i*i*r 
DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
April 12, 1978 
To RAC Members (See Attached list) 
Dear 
As you know, the proposed revisions to the NIH Guidelines on 
Recombinant DNA Research developed by your Committee were reviewed 
at a public meeting of the Advisory Committee to the Director, NIH, 
on December 15-16, 1577. Proposed revisions were published in the 
Recombinan t DNA Technical Bulletin in September 1977 and, for 
public comment, in tne Federal Register on September 27, 1977. 
Much of the correspondence I received before the meeting spoke to 
your Committee's proposed revisions for the definition and list of 
non-novel exchangers and the recommended containment levels for 
permissible experiments where viruses and plant pathogens would be 
used . 
At the public hearing in December, there was general support for the 
recommendations of your Committee. Flexibility to allow risk assess- 
ment experiments appears to be supported especially. Further, it was 
generally agreed that experiments at the Pl/ERl level should be 
exempted from the Guidelines. 
On the basis of the correspondence received before the hearing and 
testimony at the hearing, a "Joint U.S./EMBO Workshop to Assess Risks 
for Recombinant DNA Experiments Involving the Genomes of Animal, 
Plant and Insect Viruses" was convened on January 26-28, 1978. 
The report of the Workshop was reviewed by a Working Group sponsored 
by NIH on April 6-7, 1978. Recommendations have been referred 
to you for your consideration at the forthcoming meeting. 
Further, a meeting of agricultural scientists was convened March 20- 
21, 1978, under the joint sponsorship of the Department of Agriculture, 
the National Science Foundation, and the National Institutes of 
Health. Their recommendations are also before you for consideration. 
Over the past three months an analysis has been completed of all 
comments voiced at the public hearing in December and in correspond- 
ence received before and after that hearing. I have met regularly 
with your chairman and other members of our staff to consider 
these comments. 
On the basis of our analysis, a number of revisions are suggested which 
I ask you to review at your next meeting. I would very much appreciate 
your judgment on the possible revisions proposed in the enclosed 
document . 
[ 497 ] 
