Dr. Cohen said that he sensed a consensus that certain types of non-reccmbinant 
transgenic animal experiments should be covered by the NIH Guidelines. 
Dr. Gottesman suggested that the working group work from the proposed changes 
to the NIH Guidelines recommended by the Recombinant DNA Advisory Committee at 
its meeting on September 21, 1987. These changes have not yet been promulgated 
by the NIH. 
Dr. Gottesman proposed that the working group recommend a narrow change to 
cover DNA derived from recombinant DNA, and addition of wording regarding 
production of potential undesirable traits in the host animal. She noted that 
changing the definition of recombinant DNA in Section I-B would be a very broad 
change. Dr. Neiman felt Dr. Gottesman 's proposal went a long way to cover 
the types of experiments under discussion. 
After further discussion, the working group recommended that the following 
proposed changes in the NIH Guidelines be published for comment and considered 
by the RAC on June 3, 1988. 
A. On September 21, 1987, the RAC recommended that paragraph 7 as published 
for comment in the Federal Register of August 11, 1987, be incorporated 
into Section II of the NIH Guidelines as follows: 
"Biosafety Level 1 for animals (BL1-N) describes containment vhich is 
used for animals in which the germ line has been modified through 
recombinant DNA techniques (transgenic animals) and is designed to 
eliminate the possibility of sexual transmission of the modified 
genome or transmission of reccmbinan t-DNA-der ived viruses known to be 
transmitted only vertically (i.e., transmitted from animal parent to 
offspring only by sexual reproduction). Procedures, practices, and 
facilities follow classical methods of avoiding genetic exchange between 
animals." 
The working group recommended that "(transgenic animals)" be deleted from 
this paragraph. 
B. The working group recommended that the following new sentence be added at 
the beginning of Section III-B-3 before the paragraph entitled "Caution": 
"Experiments involving the introduction of eukaryotic viral gencmes 
into the germ line of animals are covered in Section III-B-4." 
C. Oi September 21, 1987, the RAC recommended that the title of Section III-B-4 
as published for comment in paragraph 32 in the Federal Register of August 11, 
1987, be changed to read as follows: 
"Recombinant DNA Experiments Involving Whole Animals." 
Recombinant DNA Research, Volume 13 
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