-4- 
problems with this structure, especially if the Guidelines 
were applied to the private sector as would occur if pending 
legislation is enacted. 
I have several specific suggestions for improvement of this 
Section . 
- Membership on the IBC or Area Biosafety Committee 
(ABC) should specifically be mandated to include significant 
worker representation and public membership. I also suggest 
that you urge consideration of members from disciplines 
in addition to the biological sciences, e.g., engineering 
and chemistry. 
- Additional emphasis should be placed on the emergency 
plans to be developed by the Biological Safety Officer. I 
suggest the addition of a requirement for a team of experts 
"on call" to handle emergency situtions. This team should 
include, among others, a medical officer and an engineer 
knowledgeable of physical and chemical containment. 
- The PRG's state that it is the responsibility of the 
Institution to "determine, in connection with each project, 
the necessity for medical surveillance of recombinant DNA 
research personnel..." In view of the fact that the effects 
of exposure are unknown, we suggest a requirement for bio- 
logical monitoring of all exposed personnel. 
- Too much responsibility lies with the Principal Inves- 
tigator. Perhaps the Biological Safety Officer should share 
this primary responsibility for enforcement. To accomplish 
this, an independent Biological Safety Officer, not engaged 
in such research, should be required at all levels of con- 
tainment (not just at the P3 and P4 levels). He or she 
should have a background in occupational or environmental 
safety and health as well as microbiology. Such a position 
is important to insure strict enforcement of procedures and 
monitoring of personnel, especially at the lower levels of 
containment where technique is so important. Standardized 
inspection reports should be filed with NIH in order to 
insure enforcement. 
- Under the PRG's, NIH notification is not required 
before research can begin. That is, once a local IBC or ABC 
has approved a specific experimental protocol and determined 
the level of physical and biological containment that it 
requires, the project may proceed without a second review at 
the federal level. I urge you to require such notification 
to strengthen your control over the uniform interpretation 
and enforcement of the guidelines. 
[A-367] 
