Dr. Fredrickscu 
- 2 - 
11/14/77 
As was the case in the original Guidelines of June 23, 1976, the question of 
protection of confidential information as it affects commercial, competitive 
enterprise arises throughout the present revision. We recommend that an 
acknowledgement be made of the need for such protection and that suitable 
statements be included in the various sections of the Guidelines to ensure 
confidentiality when necessary. Under the Freedom of Information Act, re- 
search protocols, designs, data and other research results become publicly 
available within the context of the current and proposed Guidelines. Sections 
of the Guidelines where such a statement would apply include but are not limi- 
ted to: 
II., D. , 3. - Distribution of Certified Host- Vectors 
HI., B. , 1. c. - Dowering of Containment Levels 
IV., A., paragraph 1, subsection (VI) - Submitting Information 
IV., B. , paragraph 5 - Minutes of Meetings 
Inclusion of an appropriate statement in these sections would assure voluntary 
compliance by industry with all requirements of the Guidelines in addition to 
the physical and biological containment provisions to which we are presently 
committed. This inclusion would be absolutely essential if the Guidelines are 
ever extended by legislation or regulation to cover non-f ederally funded 
research. 
H. Containment 
D. Biological Containment 
1. Levels of Containment 
a. HV1 
In general, this section is rather vague. What specifically is 
meant by "low potential for survival"? Also, are HV1 hosts 
meant to be wild type organisms or are they meant to harbor 
containment mutations? If HV1 host- vector systems are meant to be 
wild type, we propose that this section might, for example, be 
reworded as foHows: "Hosts should be wild type species or de- 
rivatives thereof which are non-pathogenic for plants or ani- 
mals and which do not contain conjugative plasmids or genera- 
lized transducing phage. Vectors should be non- conjugative 
plasmids or bacteriophages". If HV1 hosts are intended to har- 
bor containment mutations, then we propose that an HVO host- 
vector system be defined. An HVO system could then employ a 
wild type non-pathogenic organism with a non- conjugative plas- 
mid or bacteriophage vector. Experiments requiring P2+HV1 
could then be carried on jinder P3+HV0 containment. We also 
suggest that HVO systems should not require certification by 
the NIH, but approval at the institutional biohazards committee 
level. 
[Appendix A — 63] 
