Dr. Donald S. Fredrickson 
29 December 1979 
page 2 
in case of accident. HEW and NIH will not fare very well when basic science 
turns into political science. We will all suffer because of the self-interest 
of a minority of the scientific community. 
A typical example of what has occurred at RAC meetings is the proposal 
presented at the December meeting for cloning and cross country shipment of 
segments of the highly infectious foot and mouth disease virus (FMD). If I 
understand correctly, FMD is a CDC Class 5 Agent, and therefore is so potentially 
hazardous that it is by law forbidden entrance into this country. At the 
December meeting we spent the good part of a morning discussing this proposal. 
We also heard from scientists from the Plum Island Animal Disease Center who 
proposed to collaborate on this work with scientists from the private firm 
Genetech Inc. (of South San Francisco). We were told that the last outbreak 
of the disease was in 1929 and that since then embargo of the virus and animals 
from certain countries has eliminated outbreak. Yet, despite the presence of 
experts involved with this proposal we were never informed by them that a more 
recent outbreak had occurred only last year. And, that the outbreak occurred 
in the immediate vicinity of the one institution working with this virus, i.e. 
nearby to Plum Island. All animals in the area had to be slaughtered. We learned 
of this fact only after the vote on the proposal had occurred. This information 
was presented to us not by one of the experts in this area but by Shelly 
Krimsky, a lay member of the RAC. 
The FMD proposal also involved shipping clones of segments of this virus 
from the high containment facility at Plum Island to the minimal containment 
P2 facilty at Genetech Inc. in South San Francisco. This appears to be a 
particularly irresponsible proposal both because of the infectious nature of 
HMD and because it is to be shipped to a company which has previously according 
to NIH records been in overt violation of NIH recombinant DNA guidelines. 
Rationale for cross country shipment from an isolated high containment facility 
to a low containment facility in a densly populated area was that Genetech 
scientists would be inconvenienced if they were to travel to Plum Island to 
carry out their studies on vaccine development. That is almost as absurd as 
carrying out potentially hazardous cloning experiments to develop a vaccine 
which has not been needed in this country since 1929. Except of course, in 
the vicinity of those working with the virus. 
The FMD proposal is not an isolated one. We have received others of similar 
potential hazard especially from private industry which I am not able to mention 
because of proprietary rights involved. Granting of the E_. col i exemption will 
have the certain affect of bringing more such proposals to the RAC and more 
pressure to approve them. This pressure caused the RAC to vote for elimination 
of even simple registration of experiments with local biohazard committees 
for those experiments falling under the E_. coli exemption. The rationale here 
was that it would eliminate tedious paperwork. This may benefit the scientists 
involved but it is not in the public interest. 
It is not easy nor pleasant to take the position I have taken in opposition 
to most of my peers. However, lowering of guidelines for containment or granting 
of exemption will not make the potential hazards disappear, scientific or 
political. Based on NIH sponsored risk assessment studies the biological 
hazardous appear no less than they were considered to be when the guidelines 
were written several years ago. 
Associate Professor 
cc: Bill Gartland, Jane Setlow, Shelly Krimsky, Roy Curtis, Stuart Levy, 
Richard Krause 
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