3 
One can imagine that large scale production of specific human 
proteins, at the P2/EK1 levels the revised guidelines would 
permit, might conceivably bring about an immune response as 
well as some resulting disease in those working with the 
strain. The bacterial synthesis of large quantities of insulin, 
as is already being undertaken, is one case where this might 
occur in the near future. Exposure to an altered human protein 
might not only occur via the intestine. An EKl host (namely E. coli 
K12) producing human proteins, reaching the bloodstream after 
penetrating the skin accidently, might persist in the body for 
several days. This has been shown for a strain of E. coli K12 
injected into mice (9) . The length of time during which the 
autoimmune response develops may enhance the seriousness of 
the resulting disease. 
Individual academic or industrial laboratory workers will be 
the first to discover the hazards of autoimmune diseases, not 
the general population. It is a hazard of the workplace and 
not an epidemic hazard. The NIH has not given serious consider- 
ation to this problem. 
The NIH role in developing and changing thse guidelines needs 
to be examined. First, will the guidelines be altered from 
now on, piece by piece, at the NIH director's discretion, with 
no possibility for further public hearings? Second, many scientists 
still have important concerns about the safety of the research. 
Nominations to the RAC, and the qualifications of the nominees, 
should be openly discussed. A final requirement for active, 
informed, public participation — all institutional biohazards 
committee meetings whould be open to the public. It is not enough 
that the minutes alone be available for public inspection. 
Furthermore, representatives of non-doctoral , technical staff 
should be required as members of the IBC ' s . Local community 
representatives should have their nominations to the biohazards 
committee ratified by local community governments. 
Thank you for your interest in these comments, I am a member 
of Science for the People and the Coalition for Responsible 
Genetic Research, but do not represent the opinions of either 
group. I have benefitted greatly from discussions with members 
of both in analyzing this issue. I am also a graduate student in 
the Biochemistry Department at Harvard University. 
Scott Thacher 
copies to: 
Donald Federickson, NIH 
Peter Libassi, NIH 
Douglas Costle, EPA 
Eula Bingham, OSHA 
(references follow) 
[A-372] 
