University of Rochester 
Rochester, New York 1-4627 
Vtct PIMIOCNT 
Pot CaMPU} APPAIX3 
26 Janxiary 1982 
Dr. Willian J. Gartland 
Director, Office of Heoarbinant I3NA Activities 
Building 31, Boon 4A52 
National Institutes of He^dth 
Bethesda, f^uryland 20205 
Dear Dr. Gartland; 
'Hie University of Rochester supports the proposed revisions to 
the "NIH Guidelines for Research Involving Reocrtiinant DNA Molecules" 
(the "Guidelines") proposed by the Reocrfcinant DNA Advisory Comittee 
(RAC) ^^s published in the Federal Register , 4 Deoerter 1981, page 59368 
et seq . 
It has long been our philosophy that institutions suoh as 
universities should ta)ce all reasonable precautions in laboratory 
practices to protect the heedth and safety of the oorrnmity as well as 
laboratory personnel. Suoh precautions should be taken not only with 
reocrtinant ENA procedures but adso with procedures involving such 
matters as toxic agents, radiation and radioactive substances, 
pathogenic microorgeuiisms and more familiar dangers such as electric 
shock, and fire. Self-regulation rather than rtandatory federad 
regulations can and should be used to acoonplish these ends. 
One of the primary reasons for the development of the federad 
"Guidelines" was to prevmt the unintentional construction of highly 
pathogenic and contagious microorganisms which oould produce 
uncontrollable epidemics. The experierx^e of mxnerous laboratory 
directors and scientists performing reocrtjinant DNA reseauxdi suggests 
that such presumed danger does not exist. In fact, with the approved 
vectors used in recombinant DNA procedures, the pathogenicity of 
aurtificially constructed mic r oo r g a nisms hais proven to be far less than 
that of the naturadly occurring host. 
While we are in oorplete agreement that control of biological 
systems involving reocmbinant DNA should be at a level consistent with 
the appradsed risk, we do not believe that the ^ facto regulation of 
reoonbinant DNA reseaurch, ais represented hy the current "Guidelines" or 
by the Gotteanan Proposal (FR 12/7/81) is necessary to achieve adequate 
control. vie believe that guidelines aue highly desirable if they 
contain recommendations based on the best understanding at the time of 
issue of the mechanisms for attaining control. Tb this end the RAC has 
already pirovided valuable service and is undoubtedly the proper body for 
ongoing review and modification of any "Guidelines." Similarly, the 
"Laboratory Safety Monograph" has proved imensely valuable in providing 
investigators guidance in safe handling of hazardous naterials, 
including many kinds that bear no relation to recombinant DNA. 
(6951 
