- 2 - 
One of the requirements of the Cambridge City Ordinance for Recombinant 
ONA research, responding to the many concerns about the lack of concrete data 
on the risks of many varieties of experiments was a strong program of medical 
surveillance and epidemiological monitoring. 
An argument has been made for a single national standard under which 
recombinant DNA molecule work would be carried out In contrast to a minimum 
standard with additional requirements established by states or local commun- 
ities. This argument Is severely weakened when individual Institutions are 
permitted considerable discretion In such areas as medical surveillance. 
Since the guidelines may be serving as the standard to which many private 
laboratories will conform, I believe It Is Important that medical surveillance 
criteria be specified In greater detail. At the minimum, for each laboratory 
engaged In recombinant DNA molecule work there should be a mandatory require- 
ment that: 
(1) records be kept of all agents used 
(2) records be kept of all modified organisms created 
(3) records be kept on all laboratory acquired Illnesses 
(this may be covered In Sect. IV A-4-n-(3) 
( 4 ) maintenance of base line serum 
The above Information should be available to local public health 
officials. 
2. Insltutlonal Bio-Safety Committee ( I Be ) 
To avoid cases of conflict of Interest, no member of the IBC should be 
an Individual who Is principal Investigator actively engaged In recombinant 
DNA research. I propose this In lieu of the weaker provision (Sect. IV -A-2) 
No member of an IBC may be Involved (except to provide Information requested 
by the IBC) In the review or approval of a project In which he or she has 
been, or expects to be engaged, or has a direct financial Interest. 
Under Section IV -A-2-b an IBC can approve single step reductions In 
containment levels for certain experiments, without review and final approval 
of NIH. This Is a worrisome provision for the following reason. The Impact 
of having a standardized review process Is lost If substantial discretionary 
decisions such as step-wise reductions In containment are given to local boards. 
Single-step reductions In containment levels from P3 to represent a sub- 
stantial reduction In safety. That such decisions will be made without the 
oversight and final review by NIH will reinforce a weakening of the regulatory 
process. 
3. Biological Safety Officer 
Under Section IV -A-3 a biological safety officer Is required for those 
Institutions engaged In recombinant DNA research at the P-3 or P-4 level. 
Since the Impetus has been to reduce the containment levels for experiments 
while the classification of experiment types of those levels Is still a subject 
of considerable controversy among members of the scientific community, I propose 
that a biological safety officer should be designated for any Institution where 
any recombinant DNA work Is carried out. 
[A-93] 
