The Honorable Patricia Roberts Harris 
^tecember 30, 1 9* ** V 9 
Page Two 
1. A fundamental but unexamined assumption of the analysis in section 
III-B (see discussion following question 1) is that all work with E.coli 
host-vector systems would be conducted at the "PI" level of physical 
containment in which various safeguards would be maintained. Specifically, 
the analysis assumes a ban on mouth pipetting and a requirement that 
all wastes be decontaminated before disposal--two major means of pre- 
venting exposure to or dissemination into the environment of large 
numbers of microorganisms containing recombinant DNA.* 
It needs emphasis that there is currently no requirement (only a 
recommendation) that institutions require workers in this field to be 
trained in good laboratory practice. Experience in the environ- 
mental and occupational health and safety fields shows that 
safety standards can be difficult to maintain even when the dangers are 
well understood and mandatory controls and training programs are in 
place. Is it then not wildly optimistic to assume that all workers 
in this expanding and competitive field will maintain high standards 
of laboratory practice in the absence of controls and of required 
training? Under such conditions, a more plausible assumption is that 
PI containment will not be maintained, that accidents will occur, and 
that there will be cases of exposure to large numbers of E.coli bacteria. 
/'wC 
2. Many of the arguments developed in section III-B have been used 
previously to justify the revision of the guidelines (resulting in 
substantial lowering of containment levels and weakening of adminis- 
trative controls) published in December, 1978. (See, e.g., the arguments 
following questions 2,3,4,6,7,10 (in part), and 12.) All of the re- 
maining arguments, except one, are based on data that is either 
controversial (e.g. the results of the Rowe-Martin experiment, used 
in response to question 10); or incomplete (e.g. the results of the 
experiments of Levy et al . on survival of E.coli host-vector systems 
in the mammalian intestinal tract, used in response to question 10); 
or inconclusive (e.g. the data collected by Richmond, used in response 
to question 8, and the results of Brown and Burnett, used in response 
to question 9) ; or not sufficiently comprehensive to justify an across- 
the-board removal of controls (e.g. the results of Chan et al . used 
in response to question 5) . In the remaining case (question 11) , the 
argument is not based on empirical data but on the opinions of scientists 
who either do or do not believe that strains of E.coli producing modi- 
fied peptide hormones might induce autoimmune responses in humans. 
These conflicting opinions are hardly conclusive. In fact, they under- 
score the need for empirical assessment, as proposed in the NIH risk 
assessment plan of September, 1979. 
* Mouth pipetting and disposal of active biological wastes are not 
the only routes of exposure or dissemination. Other routes, e.g. in- 
jection, which can occur either through cuts with broken glassware or 
through accidents with hypodermic syringes , are not explored in this 
document . 
** See attached analysis. 
[ 626 ] 
