CALIFORNIA INSTITUTE OF TECHNOLOGY 
PASADENA. CALIFORNIA 9112S 
DIVISION OF BIOLOGY 100-29 
September 22, 1978 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Sir: 
At its last meeting, our Institute Biohazards Committee discussed the 
Proposed Revised Guidelines published in the Federal Register on Friday, 
July 29, 1978. Comments about these Guidelines were favorable with one 
exception. It is unclear to our Committee why Section IV-A-l-e (concerning 
medical surveillance) is so written. On the one hand, at the Falmouth 
Conference, the conferees agreed unanimously that E. coli K12 cannot be 
converted into an epidemic pathogen by laboratory manipulations with DNA 
inserts. On the other hand, any risk associated with recombinant DNA work 
is purely hypothetical and no medical procedures exist to test for such 
risks. Thus, taking of routine serum samples, collection of detailed 
medical records, and involvement of the local public health authorities 
would seem to serve no useful function while being expensive, both in terms 
of time and money. Although it is true that the Guidelines do not require 
such detailed surveillance, but merely suggest it, it is also true that 
such a suggestion as part of the Guidelines carries the implication that 
such surveillance should be maintained. The experience of the past several 
yeans has been that recombinant DNA work is safe, and to introduce at this 
time more detailed requirements for such work seems unjustified. It would 
seem sufficient to maintain the current level of medical surveillance, 
namely, that any serious or extended illness be investigated. We are also 
of the opinion that some of the medical surveillance procedures detailed 
on page 203 of the accompanying monograph on laboratory safety constitutes 
a serious invasion of privacy which is unjustified in the absence of 
compelling reasons to collect such data. 
Sincerely 
X Jam< 
Ass< 
Barnes H. Strauss 
Associate Professor 
Chairman, Institute Biohazards Committee 
JHS gc 
[A-253] 
