-3- 
is necessary. Section I-E-4 would exempt certain recombinant 
DNA experiments on the basis of genetic exchange. It is not 
clear what scientific information is required for inclusion 
on this list, nor what administrative procedures will be 
followed to assure public participation in future additions 
or deletions. I suggest that prior to any decision, NIH 
make available to the public any experimental evidence which 
documents genetic exchange, and that such exemptions should 
be listed as pairs of exchangers by species, and not genus 
as is currently proposed. 
- Section II-A of the PRG deals with Standard Practices 
and Training, for the purpose of containment. Containment is 
dependent on good microbiological techniques as much as tech- 
nological or biological controls. Both the Guidelines and 
the PRG ' s require "adequate instruction." I suggest that you 
develop a specific curriculum to be followed in the training 
of recombinant DNA workers and require certification that 
this training has taken place for each worker. 
- The current Guidelines prohibit mouth pipetting at the 
P2, P3 , and P4 levels of physical containment, but it is 
allowable at the Pi level. I commend you for your decision 
in the PRG's to ban mouth pipetting at all containment levels 
as this greatly improves the concept of safety at the PI level. 
- Part IV of the 1976 Guidelines, Roles and Responsibili- 
ties, provide the administrative framework for implementation 
of the Guidelines. This requires that the Principal Investi- 
gator assess any potential biohazards, institute appropriate 
safeguards and procedures and prevent accidents and illnesses. 
Where research is conducted at a P3 or P4 level, there must 
be a Biological Safety Officer who must verify training, 
inspect for compliance with safety standards, develop plans 
for dealing with accidental spills and personal contamination, 
investigate accidents, review medical effects on the person- 
nel, and provide advice on laboratory security. Each 
institution must have an Institutional Biosafety Committee 
(IBC) to give advice on policies, to create and maintain a 
central reference file, and to develop a safety and operations 
manual for any P4 facility. 
The PRG's give increased local authority for implementation 
of the guidelines. The local biosafety committee has also 
been given the primary responsibility for the review, deter- 
mination of containment levels, and approval of initiation 
of all recombinant DNA research at that facility. I feel 
that too much responsibility for interpretation and enforce- 
ment has been placed at the local level. I anticipate many 
[A-366] 
