APPENDIX J

- 1-

A Plausible Model for Monitoring Compliance

      with Containment Guidelines

There is a need to determine whether a particular

laboratory engaged in or beginning recombinant DNA research has

the appropriate containment capability for a given type of experiment,

Insofar as possible this review process should not lengthen the time

required for review of research proposals.

is designed for the grant review process and laboratories in univer-

sities or research centers in the United States.

with certain modifications, it could be adapted to the corresponding

institutions in other countries,

The following model

Quite possibly,

Each university or research institution would have a biological

safety office whose responsibility would be to assess or

grade the physical containment facilities of its laboratories (e. g.,

assigning a rating of low, moderate or high risk containment according

to established guidelines).

laboratory head with a statement certifying the physical Containment

rating of the laboratory; this rating would, of course, be subject to

periodic reevaluation.

This local office would provide the

When an investigator applies to an agency for funds to support

work on recombinant DNA molecules, the statement certifying the

physical containment rating would be appended to the grant proposal.

The group reviewing the research proposal would determine whether

the certified level of physical containment was adequate for the

real or potential biohazard associated with the proposed experiments.
Entering into the assessment of adequacy would be the type of DNA
to be cloned, the scale of the proposed bacterial cultures to be used

and most importantly the adequacy of the biologic barriers

to be employed.
design and physical containment rating is commensurate with their
and the investigator's estimate of the risk, the grant would be processed

for scientific merit in the usual fashion.
of the adequacy of the containment capability, the experimental design
or the investigator's estimate of the risks, the matter would be
referred to an appropriate body (e. g., the NIH Advisory Cornmittee
on Recombinant DNA Molecules or its designate) for an opinion or

ruling.

If the reviewing group concludes that the experimental

If there is some question

This proposed procedure would apply to new or renewal grant

applications but it would clearly miss investigations supported by con-

tinuing grant support or by agencies not using such a monitoring
mechanism. Nevertheless, it is likely that most investigators,
because of self interest and a sense of responsibility to their colleagues,
coworkers and other laboratory personnel, would comply with the

same guidelines .