Federal Register / Vol. 49, No. 179 / Thursday, September 13, 1984 / Notices 
36057 
the American Associations for the 
Advancement of Science (AAAS) held a 
panel on biological-warfare at their annual 
meeting at which a spokesperson from the 
Defense Information Agency pointed out the 
convertibility between peaceful uses of this 
technology and military applications; and (3) 
Environmental Action and the Foundation on 
Economic Trends joined in releasing to the 
public a mathematical model from the leading 
Soviet mathematical modeler of 
epidemiological studies. This scientist is 
concerned that the mathematical model he 
developed for tracing and tracking viruses 
could be used for military purposes. 
Mr. Rifkin said he was curious about the 
interest in Shiga toxin because it was his 
understanding that this particular form of 
dysentery is not found in any significant way 
in the United States but is pandemic to the 
five countries of Central America. He said: 
“. . . it doesn't take much intelligence to 
understand that it would be very helpful to 
have such a vaccine, if for no oth<5r reason, to 
inoculate U.S. ground troops." 
He added that: 
"U.S. ground troops having that kind of 
vaccine would be able to be in a position to 
be deployed in those five Central American 
countries with the protection of that vaccine." 
Mr. Rifkin suggested that RAC: 
“. . . postpone consideration of this 
experiment and similar experiments by DOD 
or DOD-related institutions until such time as 
another agency, the Arms Control and 
Disarmament Agency, complies with the 
ACIS requirements." 
Mr. Rifkin called the attention of the 
committee to the letter from Dr. Jay Sanford. 
President of the Uniformed Services 
University of the Health Sciences, which 
states that the Department of Defense (DOD) 
does not believe these experiments will have 
a significant impact on arms control and 
disarmament. Mr. Rifkin said that the Arms 
Control and Disarmament Agency is the 
agency which has to deal with it, not the 
DOD. 
Mr. Rifkin suggested that RAC discuss 
setting up a RAC subgroup to: 
“. . . take a look at this whole area of 
convertibility of toxins from peaceful uses to 
military uses and to initiate a very exhaustive 
study, complete with recommendations and 
findings, to bring back to this committee for 
discussion at a future date." 
Mr. Rifkin also suggested that the 
subgroup: 
". . . look at all of the ways that we might 
deal with controls, regulations, protocols, and 
procedures dealing with this whole question 
of toxins used for domestic purposes versus 
military." 
Dr. Levine said he wished to offer a few 
clarifications. He explained that: 
“Shiga toxin was originally isolated from a 
serotype of Shigella called Shigella 
dysenteriae-1, or Shiga. That particular 
organism caused pandemic dysentery in 
Central America from 1968-1970. There no 
longer is a pandemic in Central America. 
There hasn't been for many years. In fact, it’s 
an uncommon endemic organism in Central 
America. Shigella Dysenteriae-1. amongst all 
Shigella, amongst all bacteria, is one of only 
a handful of organisms that are capable of 
exhibiting pandemic spread, and that occurs 
every couple of generations interspersed 
widely throughout the world. One does not 
really know why it turns up. There was a 
similar large epidemic in Bangladesh in the 
1970s, for example; there was one 15 years 
earlier in East Africa. There is no Shiga 
dysentery pandemic in Central America 
now. . . . 
The genes, however, that Shigella 
dysenteriae-1 have, we now recognize arejn 
all Shigella, or apparently all Shigella, 
because all Shigella serotypes that have been 
looked at are now found to produce this 
toxin. And what’s much more important, E. 
coli can produce lots of Shiga toxin. . . . 
The last point I would make, Mr. Chairman, 
is that it bothers me, as a health worker and 
health professional interested in geographic 
medicine and tropical pediatrics, to have 
such great emphasis put on one aspect of 
warfare when there's another war out there 
and it's a war that I'm involved in fighting in 
a different way and that is a war against 
disease, and that's also a real war, and that’s 
taking place now, that's not hypothetical. 
Shiga dysentery does cause disease, cholera 
causes disease. There are many, many — there 
are millions of children — that die of these 
diseases throughout the world. That's war, 
and we need every armament we have 
against that war. Without question, nefarious 
individuals in many countries can take not 
only guns and arms and such explosive 
armaments, but nefarious individuals can use 
biological means and chemical means and 
apply them in warfare without question. But 
they don't need to clone Shiga toxin to do 
this. My lord, there are so many nasty agents 
that exist for the potential for warfare that 
we know about. But there’s another war out 
there and I think it's our primary 
responsibility to come up with the best 
armaments to fight that other war. 
Mr. Rifkin said he totally agreed that: 
". . . we have a responsibility to develop 
vaccines that are going to be helpful in 
dealing with some of these dreaded diseases. 
All I'm suggesting at this point is that we're at 
a stage where there is a convertibility with 
toxins for military purposes, and just as we're 
interested in solving the problem of diseases, 
shouldn't we be interested in setting down 
some guidelines, and protocols, and 
procedures for the potential convertibility of 
this technology . . . ." 
Mr. Rifkin asked if there was: 
“. . . any room for discussion at this 
committee of the NIH for taking a look at 
how toxin-related experiments might be 
somehow used for military purposes? If not. I 
won't bring it up again if you think that there 
is no room for this committee, or the NIH, to 
look into this matter in any way, shape, or 
form about the convertibility. I will not bring 
it up again if you so decide that that’s your — 
the NIH’s — position." 
Dr. McKinney said he: 
“. . . would make the observation, Mr. 
Chairman, .that if indeed our concern would 
be predicated on convertibility of any 
technology to ultimate use in warfare that we 
should have started with the invention of the 
wheel and that we would, in fact, cease to do 
any and all research in the world, in fact, 
cease to do any and all research in the world 
because of the potential for converting any 
new technology to ultimate warfare use." 
Dr. McKinney said he wished to comment 
on the materials which accompanied Mr. 
Rifki's letter of May 15, 1984. He said he had 
found a number of gross'technical errors in 
this material. He cited Mr. Rifkin's statement 
that RAC is authorizing experiments. Dr. 
McKinney said RAC does not 'authorize' 
experiments, rather it is an advisory body to 
the NIH. It is the prerogative of the NIH to 
accept or reject RAC's recommendations. Dr. 
McKinney felt the inappropriate use of the 
word 'authorize' conveys to the public a false 
impression of RAC's function. 
Dr. McKinney said he could not accept Mr. 
Rifking's position that RAC is a participant in 
the potential convertibility of a technology to 
military applications. He said such a 
potential exists with any technology. The 
primary role of RAC, however, is to serve the 
public interest. In this service, concrete 
measures to control disease have precedence 
over hypothetical considerations which might 
be raised over what somebody might do 
someday. 
Dr. Landy said he was personally offended 
by Mr. Rifkin's implication that American 
researchers would not feel compelled to 
research diseases that are not endemic to the 
United States. 
Dr. Miller of the FDA underscored the 
public health importance of the research 
proposed by Dr. O'Brien. He urged RAC to 
recommend conditions which would permit 
this research to proceed. Dr. Miller felt the: 
". . . issue of convertibility to biological 
warfare is really . . . not an issue at all, but 
rather. . . a manifestation of what the British 
journal Nature in the May 24th issue alluded 
to in describing Mr. Rifkin as someone whose 
nuisance to substance ratio is high.” 
Dr. Rapp said a toxin is one type of 
virulence factor. If instead of using the word 1 
“toxin." the words "virulence factors" were 
used, many experiments with important 
health problem applications would be part of 
the convertibility discussion. 
Dr. Rapp strongly supported Dr. Landy's 
comments. He offered as an example the 
research being conducted in the U.S. on 
malaria. He did not think the U.S. was going 
to invade West Africa because U.S. 
researchers are studying malaria. Malaria is 
an important international health problems 
and most U.S. researchers consider 
themselves international scientists 
attempting to solve world health problems. 
Dr. Walter's agreed. 
Dr. McCarrity pointed to Appendix F as 
evidence that RAC and the Working Group 
on Toxins have deliberated long and hard in 
considering recombinant DNA experiments 
involving toxin genes. 
Dr. Gottesman said the concern that this 
research might be converted to uses scientists 
would not approve is one reason scientists 
began the process of evaluating applications 
of the recombinant DNA technique. This 
concern was discussed at Asilomar. The RAC 
meets in open session to keep the public 
aware of the issues. 
Dr. Gottesman said she was bothered a 
great deal by Mr. Rifkin's implication that 
these experiments are more likely to be 
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