MEMORANDUM 
to Director, NIH 
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES Of HEALTH 
date: November 11, 1977 
from Wallace P. Rowe, M.D. 
subject Comments on Proposed Revised Guidelines for Recombinant DNA Research 
as published in Federal Register September 27, 1977. 
As you know, I am a member of the Committee that prepared the revised 
guidelines. On rereading them I noted some generally minor points that 
need clarification, and I am writing as an individual to bring them to 
your attention. 
The recommended changes, and the reasons therefore are as follows: 
1. p. 49601, Col. 3, line 24. Change the phrase in parentheses to 
read: "(i.e., not productively infected as demonstrated by standard 
assays for the common viruses of the species under study)". 
- This clarifies what the investigator must do to meet the 
requirement. 
2. p. 49602, Col. 2, line 84. This section should cross reference 
to the stated requirements for lowering containment for clones with DNA 
inserts from viruses of eukaryotes, in order to make it clear that the 
proposed mechanisms apply to these containment reductions and are not in 
addition to them. This could perhaps be handled by adding this sentence 
at the end of col. 3, line 2: "Criteria for lowering containment condi- 
tions for clones containing DNA from viruses of eukaryotes were given in 
section III.B.l .b.(l )." 
3. p. 49602, Col. 3, line 58. Change the word "infectious" to 
"progeny" . 
4. p. 49602, Col. 3, line 61. Change the word "significant" to 
"a high degree of" . 
- This eliminates confusion as to why SV40, Ad. 2, and Ad. 5 are 
not disqualified; they can be pathogenic, but are not highly pathogenic 
in any sense of the term. 
5. p. 49602, Col. 3. In the sentence beginning on line 78, the 
antecedent of "limitation" is not immediately clear. It would help to 
change the sentence to read: "Subject to the limitation In (i) above, 
(that is, that the genome not be from an agent that Is infectious for 
humans or that replicates to a significant extent in human cells in tissue 
culture), it Is not required... 
[Appendix A — 55] 
