Brigham and Women’s Hospital 
A Teaching Affiliate of Harvard Medical School 
75 Francis Street, Boston. Massachusetts 02115 
(617) 732-6803 
January 28, 1982 
William Gartland, Ph.D. 
Director 
Office of Recombinant DMA Activities 
Building 31, 4A52 
Bethesda, Maryland 20205 
Dear Dr. Gartland: 
The Institutional Biosafety Committee of Harvard Medical Area would 
like to register Its concern about the proposed relaxation of the 
Guidelines for Recombinant DNA research. We are concerned primarily 
because In our work as a committee we have found It necessary to 
weight safety Issues In Individual protocols in this rapidly chang- 
ing field, and we have the sense that some continuing uniform level 
of evaluation Is stlH needed. We suggest that a deliberate and 
systematic phasing out of restrictions found to be unnecessary would 
make more sense than such an abrupt change as Is being proposed by 
the Recombinant Advisory Committee. 
In addition, a number of local communities throughout the country 
have enacted legislation to regulate this research. By in large the 
legislation defers to the NIH Guidelines for content. It has been 
possible for communities to accept these guidelines Intact because of 
National Institutes of Health's reputation. It Is our concern that 
the relaxation of the NIH Guidelines would lead some local communities 
to regulate this activity with different standards. The Impact of 
such an occurrence could be devastating to the scientific community 
and the public In the long term. 
We also see a potential problem with both proposals referencing the 
use of the CDC classification system as a guide for assessing the 
containment of recombinant DNA experiments. Acceptance of the revised 
CDC biosafety guidelines is certainly in question at this time. The 
ASM Public and Scientific Affairs Board has expressed the recommenda- 
tion that laboratory safety should be left to the judgement and dis- 
cretion of the investigator. It is our understanding that CDC will 
retract its most recent classification of etiologic agents. Does this 
not place the proposed NIH containment assessment scheme In trouble? 
Boston Hospital for Women/Pcter Bent Brigham Hospital/Robert B. Brigham Hospital/Brookside Park 
Family Life Center/Soothem Jamaica Plain Health Center/Peter Bent Brigham School of Nursing 
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