The rDNA Debate

The rDNA Policy Makers

Historical Events in the rDNA Debate

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Historical Events in the rDNA Debate

Phase I [1971- Feb 1975 - realization of potential (1971) to Asilomar Conference (Feb 1975)]

In the summer of 1971, experiments were planned to introduce SV40 DNA into an E. coli cell. This was of concern because SV40 is a monkey virus that can transform monkey as well as human cell lines into a cancerous state. These experiments were postponed.

In June 1973, a Gordon Conference discussion related to safety issues of rDNA lab workers was held. National Institute of Health (NIH) and National Insitute of Medicine (NIM) was asked to appoint a committee to study the matter. At the same time, letters were sent by notable scientists to the journals Science and Nature calling for a temporary halt to rDNA experiments.  This request was unheard of before in the history of science.  A Recombinant DNA advisory committee (RAC) set up at the behest of the scientific committee by the NIH.

In February 1975, the Asilomar Conference was held to discuss the relevant issues.  The conclusion of this scientific conference was that most rDNA work should continue, but appropriate safeguards in the form of physical and biological containment procedures should be put in place.

Because in retrospect the Asilomar conference has appeared to be a pivotal event, it is important to assess the role of the Conference. Specifically,

  • Was it a model of scientific initiative and social responsibility?
  • Was it a disaster because of poor planning?
  • Were the results constructive or destructive?

The conference was clearly was the first step in a public policy process.  It was organized as a scientific conferences, but the legal and journalistic representation suggested organizers knew important public policy issues were being discussed.  The conference was convened as a scientific conference under the auspices of the NIH because:

  • NIH was a major financial supporter of the research
  • The government was a potential major controlling factor of the research
  • Recombinant DNA Advisory Committee had already been created

The motivation for the conference was address the issue of the potential of the research as a biohazard.  Such question considered were:

  • Was a dangerous escape possible?
  • Wanted to classify the danger of all the recombinants
  • Wanted to create guidelines, not regulations

What needs to be considered was the conference a good starting point for policy decisions regarding biohazards?  In retrospect, the conference was actually too narrow because the debate was among molecular biologists who were not trained in microbiology infectious diseases, epidemiology and public health.  Consequently, this poor training probably lead to an overstating at the conference of the biohazards of recombinanat DNA research.  Because a single group dominated the conference, full access to the decision making process was not available to all. For effective public policy, full access to all possible affected individuals is important.  Therefore, broadening the groups involved would have improved the overall process.

What successes came from the conference?  First, little real restrictions have been placed on the research.  And in the long term more importantly, scientists showed to the public that they were concerned about the issues.

What were the long-term ramifications?  First, the government became involved in regulating the research.  Secondly, because the conference agenda focused the debate on the potential biohazards, all of the later debate was focused on "worst case scenarios" of recombinant DNA research.  This is still seen today.  When any issue related to the technology is discussed many "disasters" are proposed as reasons to prevent the research from occurring. Finally, the conference helped to humanize science and scientists because this was the first time that research was halted by scientists themselves until the potential hazards could be assessed.  

This conference highlighted the fact that policy arises from both private and public debate.  Although the conference was controlled by a single group (molecular biologists), the outcome was that  other scientists and non-scientists are now on national and local review boards.  This non-scientist representation is a direct result of public debate.  If the discussion was held in private, the experts involved in the decision-making processes would probably not beconsidered credible.

rDNA and the Press

Because at the time rDNA research was not known widely by the public, no physical manifestation was igniting fear in the public.  If a lab accident had occurred, widespread hysteria could have halted research in the US.  Without vigilance by the general and scientific press, apathy could lead to sloppy research that might have caused hysteria among the public.

So how was the press involved?  The scientific press did cover the publishing of the article by Singer and Söll (Science 9/21/73) and Berg (Science 7/19/74) that called for the moratorium on the research.  

But the general press was not covering the story until it became a competitive story from a journalistic perspective.  What the press knew was that scientists wanted a moratorium on experiments because of the uncertainty about safety.  This issue was be debated at a time when the Ecology/Environment movement was beginning.  This immediately gave it a flavor of relevancy.

So when the press actually became fully involved, the issue had evolved to the point where it appeared to be a panicky situation. The press was required to report the seemingly outrageous statements of some even if they were scientifically incorrect.  Again this has had the long term effect of having the research immediately being discussed from a negative, rather than positive perspective.

Phase II (Feb 1975 - June 1976 - through development of NIH guidelines; 1st time the public was involved)

During this time frame, broad social and ethical issues are begun to be addressed.  This included:

  • what is the relationship between scientific freedom of inquiry and protection of societies interest
  • who makes the decisions and what is the public's role in this decision making proces

Also, during this period the public debate and the Federal response to that debate was defined.  This was the first time that debate went beyond the scientific community.  This broadening of the discussion also had an effect on the RAC committee membership.

It also was in this time frame that the rDNA decision making mechanism was developed.  First, RAC membership was a concern. Originally the committee had 12 members from molecular biology, genetics, virology and microbiology. It was expanded to 16 members with the fields of epidemiology, infectious diseases and the biology of enteric organisms represented. Because of the broadening of the debate into include lay individuals, two non-scientists were added.

Originally RAC Guidelines were stricter than those set out at Asilomar. But, critics still contended that they did not go far enough. One question that arose regarded the ethics of a group of individuals regulating themselves. Furthermore, who gave this group the authority to regulate other federal agencies as well as private industry.  Phase II ended when the Guidelines for Research Involving Recombinant DNA Molecules were published on June 23, 1976. As written, these guidelines only applied to federally funded research.

Phase III (mid 1976 - mid 1978 - congressional consideration of legislation; initially thought that passage of public law was imminent, but finally no law was passed)

Immediately legislative activity began to broaden the scope of the regulations to include all of the US research community. Legislation was introduced that would cover these loop holes. Three developments minimized the impetus for the legislation.

First, RAC role was expanded. Its membership was further broadened to include botany, plant pathology and tissue culture. Membership rose from 16 to 20 to include members from other disciplines and the general public. Responsibilities of the RAC were given in more detail and broadened to include the review of large-scale experiments.

Secondly, scientists were coming to the conclusion that the research was less dangerous than originally thought. Specific strains of E. coli were shown to be effective control agents for the spread of engineered molecules. And it was demonstrated that exchanges of genetic information had indeed occurred naturally between lower and higher life forms. This suggested that rDNA was not as novel in nature as first thought.

Thirdly, a large lobbying effort by scientists, based on the belief that the technology was not dangerous was successful in stalling the legislation. The legislators proposing the legislation, sensing defeat, called on the federal regulatory agencies to close any loopholes in the guidelines.

Phase IV (post 1978 - post legislative period)

In response to the conclusions regarding safety, RAC lowered the containment level for many experiments. At this point, the Secretary of HEW (now HHS) became actively involved. He took over appointments to RAC. He also asked for a review of the RAC and the IBC (local Institutional Biosafety Committee which approve projects at the individual institution level).

A large public hearing was held on September 15, 1978, and the 170 letters specifically addressing the issue lead to a major change in the guidelines. The changes increased the public participation in the IBC to 20%, ensured that most of the records were made public, and required major decisions to be forwarded to the RAC for approval.

To ensure industrial compliance with the guidelines, FDA gave notice that any product developed using rDNA procedures must have been developed with compliance to the guidelines. The EPA also adapted this approach, so effectively all research was complying with the guidelines.

Copyright © 1997. Phillip McClean