Dr. F redrickson 
- 5 - 
11/14/77 
The experimental Guidelines - for "viruses of plants" 
specify P2 + EK2 or P3 +■ EK1 containment. Since the two 
types of containment are complementary, the flexibility 
provided by balancing changes in physical containment 
with changes in biological containment is certainly reason- 
able. From the standpoint of the experimenter, such flex- 
ibility is also most desirable, since many more types of 
experiments are possible using EK1 vectors. The failure 
to provide a similar flexibility for other P2 + EK2 experi- 
ments, for example, shotgun experiments with DNA from 
mammals other than primates, or from birds appears to be 
inconsistent. 
c. Lowering of Containment Levels for Characterized or 
Purified DNA Preparations and Clones 
The first sentence of the last paragraph of this section 
should be modified in some manner to read, for example: 
"This institutional biohazards committee (IBC) must review 
and may approve such a reduction". 
IV. Roles and Responsibilities 
D. NIH Recombinant DNA Molecule Program Advisory Committee 
The last sentence of the third paragraph of this section should be 
modified to take into account expertise in the field, for example: 
"In making recommendations for exceptions, weight ‘will be given to 
scientific and societal benefits, potential risks, and to industrial 
experience with large-scale production of pathogenic organisms and 
toxic materials". This same modified statement shouH also appear 
in Section III. , A. , third paragraph. 
We recognize that the NIH Guidelines for Recombinant DNA Research as present- 
ly constituted do not apply to research conducted in private industrial labora- 
tories; nevertheless, the spirit and intent of the Guidelines has been, and will 
continue to be, followed by PMA member firms. If, at some time in the future, 
compliance with all provisions of the Guidelines becomes mandatory for all lab- 
oratories involved in recombinant DNA research, certain procedures in the 
Guidelines will pose a difficult problem in terms of patentability of new con- 
cepts and protection of proprietary interests. With the few exceptions discussed 
in our specific comments, compliance with all other features of the Guidelines 
appears reasonable. 
As a general feature of the revision, then, we recommend the insertion of an 
acknowledgment that premature disclosure of hypotheses, protocols, designs. 
[Appendix A — 66] 
