APRIL 27-28-MINUTES OF MEETING 
3 
pose no more risk than work with the infectious virus or its nucleic 
acid and in most, if not all, cases clearly present less risk. 
Similar conclusions have been reached by agricultural scientists, 
meeting under the auspices of the USCA, NSF, and NIH, who concluded 
that current containment levels for the cloning of DNA from plant pathogens 
in E. coli K-12 are too high. Dr. Fredrickson stated that, although it 
was not possible to reduce the risk to zero, the burden of proof should 
now shift to the opponents of the research. Dr. Fredrickson then summarized 
the recent steps taken by the NIH. At the meeting of the Director's 
Advisory Comm t tee in December 1977, there was universal sentiment for 
the exemption of certain experiments from prohibition on the basis of a 
need for risk assessment . There was also agreement on the need for 
exemptions for most self-cloning experiments, and for experiments involving 
organists that are known to exchange genetic material. 
Dr. Fredrickson noted that Guidelines in other countries placed fewer 
restrictions on scientists. The current Guidelines are too complex and must 
be revised on the basis of new evidence prior to their possible promulgation 
as regulations. He then briefly described the procedures associated with 
release of a revised version of the Guidelines. This will include publication 
of the proposed revised Guidelines together with an Environmental Impact 
Assessment and a decision document explaining the rationale for the 
revisions. The public would have a period of time to comment on the 
proposed revised Guidelines. A final version would then be published. 
Dr. Fredrickson noted that members of the CAC and public commentators 
had suggested further revisions of the Guidelines. The RAC at this meeting 
must take these suggestions into consideration and make further recom- 
mendations. Among the issues that need to be addressed are a revised 
definition of recombinant DNA, changes in the scope of the Guidelines, 
a list of exempted exchangers, alterations in the roles and responsibilities 
of the investigator, institution and NIH, and the changes in the containment 
guidelines for covered experiments particularly those involving viruses 
and plant pathogens. Dr. Fredrickson continued by describing in further detail 
the scope of some of the changes. He noted that in the proposed revision 
the list of prohibited experiments would precede any list of exemptions. 
There was no need at the mcment to remove any prohibitions. The following 
five classes of exemptions are proposed: recombinant DMAs not in organists 
or viruses, recombinant DNAs from a single non-chramoscmal source, recombinant 
DMAs from a host when propagated in that host, recombinant ENAs from species 
that exchange DNA by physiological processes, and recombinant DNAs that do 
not present a significant risk to health or the environment. In response 
to a question from Dr. Hel inski of the RAC, Dr. Fredrickson stated that 
the definition of exchanging species could include both chromosomal and 
plasnid exchangers as long as standards were set. He also pointed out 
that the definition of recombinant DNA did not represent a change from a 
previous draft, but now included the concepts of exemptions and synthetic 
DNA. 
[ 519 ] 
