[Excerpt from Donald S. Fredrickson's diary on the exemption of E. coli experiments from the NIH Guidelines for Research
Involving Recombinant DNA Molecules]
In the revised NIH guidelines for recombinant DNA research released in January 1979, containment requirements for experiments
with Escherichia coli (E. coli) strain K-12, the most commonly-used host-vector system in recombinant DNA research, were greatly
eased. This reflected a growing realization that experiments during which foreign DNA fragments were inserted into this strain
of E. coli did not present the environmental hazards earlier feared by scientists.
Number of Image Pages:
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1979-10-29 (October 29, 1979)
Fredrickson, Donald S.
This item is in the public domain. It may be used without permission.
The Controversy over the Regulation of Recombinant DNA Research, 1975-1981
Infection Risk Small in Some DNA Experiments [ca. 1979]
Letter from Philip L. Bereano to Patricia Harris, Department of Health, Education, and Welfare (November 21, 1979)
Letter from Richard Goldstein to Donald S. Fredrickson (December 29, 1979)
Letter from Susan Wright to Patricia Harris, Department of Health, Education, and Welfare (December 30, 1979)
Letter from Francine Robinson, Coalition for Responsible Genetic Research to Patricia Harris, Department of Health, Education,
and Welfare (January 21, 1980)
The press reports of the "PI/EKl recommendationl" by the RAC have really brought out the hate mail. The correspondence
includes Simring, Hartzman, Bereano (even Goldstein and two other members of the RAC), plus Solomon Garb, most of the letters
contain the predictable reflexes. This has been a difficult issue, however, because it was decided by a divided vote of the
RAC. After the RAC acted, on September 7, I waited for the documents from Gartland. When we met in the last week in September,
I was put out to find that Dr. Elizabeth Milewski, a
new ORDA staff member, had prepared an extensive analysis of her own views of why the RAC minority was right. I thought this
proper, but not before I received a full analysis of the decision and its background myself. ORDA must prepare these analyses
of both sides before it begins any advocacy campaigns of its own. In the bluntest of terms, I "ordered" Gartland
to prepare a full decision document in one week, and put the responsibility for its arrival ultimately upon Bernie Talbot.
A 312 page document, plus the crude transcript of the RAC discussions, arrived on my desk on time. I also requested the actual
tapes, but did not listen to them. I had heard the pre-vote discussion on a visit to the RAC on September 7, but from the
privacy of the audio room. Thus I knew that enmities described later, in the letters of complaint, were not there at the
actual moment of decision.
So we scheduled a full meeting of the "kitchen RAC" for mid-October. I scheduled Elizabeth W. and Sue Gottesman,
who was in the minority on the vote, to first present the views of the minority for 20 minutes. As I questioned Sue, it was
brought out that her major concern, and the only main one, related to Jonathan King's "auto-immune disease" anxiety.
I questioned Emmett Barkley closely, and his statement that for E. coli, P1 had all the essential physical containment that
one could get, P2 over P3 not adding any safety in handling enteric pathogens.
Barkley's view seemed to startle Sue and most of the opposition faded quietly. (Fortunately, I'd decided in December
to prohibit mouth pipetting in P1, a move essential to protecting against contamination in dealing with enteric pathogens).
Then 20 minutes were for Wally Rowe to give the majority view, on the P1/EK1 exemption with Maxine Singer, Mal Martin, Talbot,
Zimmerman and Perpich, and with Nalton and Barkley listening critically.
By 4:00, I'd decided how this dilemma might be resolved. There would be no "exemption", (from the needed scaleup
regulation, etc.). Instead, I would simply order that all work with EK1 had to be in P1, with no national registration needed.
For experiments where there might be protein expression, a little tougher treatment at the local level would be required.
Above all, we'd also whip up a national "hype" on P1. This would include a letter from me to the president of
institutions, enclosing a nice, bright, black and orange P1 sticker that they could put on their doors. This would put the
leadership of the institutions on notice that thev were responsible for enforcing the Guidelines.
Everyone took the order calmly. Talbot started to work. We've now been 10 days at it and are into the 3rd draft of the
order. I also went to Secretary Harris to warn her of some possible moderate flack on this decision, but urged her not to
draw the erroneous assumption that she's got to take any offical action. In this era of new guidelines, the decision
is delegated to me. (cf. decision document).