Comments on Revised Guidelines 
page 2 
For the foreseeable future, the Committee's business 
should not vary much from this description, since the large 
majority of our work will be either exempt or PI under Section 
III-C. However, we anticipate two other items arising in 1983 
which will occupy a good deal of the Committee's time: 
(a) We expect to receive a proposal sometime this year 
involving the use of a class 2 pathogen as a host 
organism. This would require Committee approval and P2 
containment under Section III-B-l-a, and we expect the 
Committee to examine this proposal carefully. 
(b) Sometime this year, our Fermentation R&D Group will 
begin to organize a fermentation laboratory which will 
include fermentors of greater than 10 liter capacity. 
Although large-scale experiments are covered by Section 
III-B-5, the Guidelines are superseded by the Cambridge 
ordinance, which mandates a special permit for these 
experiments. The first step in obtaining this permit is 
IBC approval of the plans, procedures, etc. for this 
facility. This approval process will no doubt require 
considerable Committee time and effort. After the permit 
is issued, the Committee, of course, must specifically 
approve subsequent experiments, under the Guidelines. 
We have no general problems or specific disagreements 
with the revised Guidelines. However, like most biotech firms, 
we foresee a few future problems peculiar to industrial uses 
of recombinant DNA: 
(a) Large-Scale Requirements . Unfortunately, we cannot 
make specific comments In tKis area, due to our lack of 
experience to date. In general, we support the ongoing 
dialogue between RAC and the Industrial Biotechnology 
Association, aimed at adapting the large-scale require- 
ments to better fit the needs of the biotech industry. 
(b) Release into the Environment . The current require- 
ment ~7or RAC approval ( and publication in the Federal 
Register) of such proposals might compromise our need 
for confidentiality on proposals which might arise in the 
future. Ideally, we would like RAC to be able to 
approve such experiments on a confidential basis, 
without publication in the Federal Register. 
(c) Confidentiality , in general, is a problem whenever a 
proposal need be published in the Federal Register. 
However, the experiments discussed in (b) are likely to 
be our only ones needing RAC approval and Federal 
Register publication. 
[574] 
