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Asilomar Conference

Asilomar Conference

Soon after the discovery in 1970 of the first restriction enzyme by American microbiologist Hamilton Smith, it became possible to combine DNA from different sources into one molecule, producing recombinant DNA. Concern by scientists and lay people that some of this recombinant technology DNA might be harmful to humanseither by unintentional or deliberate release or recombinant DNA into the environmentprompted the research to stop until scientists could evaluate its risks.

In February 1975, over 100 internationally respected molecular biologists met at the Asilomar conference center in California. There, they decided upon a set of guidelines to be followed by all scientists doing recombinant DNA research. They considered each class of experiments, and assigned it a level of risk: minimal, low, moderate, or high. Each level of risk required a corresponding set of containment procedures designed to minimize the chance of vectors (carriers) containing recombinant DNA molecules from escaping into the environment where they could potentially harm humans or other parts of the ecosystem. Because these projected experiments had never been done, assignment to a risk category was, of course, somewhat speculative and subjective. Accordingly, the potential risks were arrived at by estimate.

At all risk levels, the guidelines called for the use of biological barriers. Bacterial host cells should be from strains unable to survive in natural environments (outside the test tube). Vectors carrying recombinant DNA, including plasmids, bacteriophages, and other viruses, were to be nontransmissible and also unable to survive in natural environments.

For experiments having minimal risk, the guidelines recommended that scientists follow general microbiology safety procedures. These included not eating, drinking, or smoking in the lab; wearing laboratory coats in the work area; and promptly disinfecting contaminated materials.

Low risk procedures required a bit more caution. For example, procedures producing aerosols, such as using a blender, were to be performed under an enclosed ventilation hood to eliminate the risk of the recombinant DNA being liberated into the air.

Moderate risk experiments required the use of a laminar flow hood, the wearing of gloves, and the maintenance of negative air pressure in the laboratory. This would ensure that air currents did not carry recombinant DNA out of the laboratory.

Finally, in high risk experiments, maximum precautions were specified. These included isolation of the laboratory from other areas by air locks, having researchers shower and change their clothing upon leaving the work area, and the incineration of exhaust air from the hoods.

Certain types of experiments were not to be done at all. These most potentially dangerous experiments included the cloning of recombinant DNA from highly pathogenic organisms or DNA containing toxin genes. Also forbidden were experiments involved the production of more than 10 liters of culture using recombinant DNA molecules that might render the products potentially harmful to humans, animals, or plants.

The scientists at the Asilomar conference also resolved to meet annually to re-evaluate the guidelines. As new procedures were developed and safer vectors and bacterial cells became available, it became possible to reevaluate and relax some of the initially stringent and restrictive safety standards.

FURTHER READING:

PERIODICALS:

Barinaga, Marcia, "Asilomar Revisted: Lessons for Today?" Science 287 (2000).

SEE ALSO

Biocontainment Laboratories
Biodetectors
Biological Weapons, Genetic Identification
DNA Fingerprinting
DNA Recognition Instruments
DNA Sequences, Unique

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Asilomar Conference

Asilomar conference

Soon after American microbiologist Hamilton Smith's 1970 discovery of the first restriction enzyme, it became possible to combine DNA from different sources into one molecule, producing recombinant DNA. Concern by scientists and lay people that some of this recombinant-technology DNA might be harmful to humans prompted the research to stop until scientists could evaluate its risks.

In February 1975 over 100 internationally respected molecular biologists met at the Asilomar conference center in California. There they decided upon a set of guidelines to be followed by all scientists doing recombinant DNA research. They considered every class of experiment and assigned each a level of risk: minimal, low, moderate, or high. Each level of risk required a corresponding set of containment procedures designed to minimize the chance of vectors (carriers) containing recombinant DNA molecules from escaping into the environment, where they could potentially harm humans or other parts of the ecosystem. Because these projected experiments had never been done, assignment to a risk category was, of course, somewhat speculative and subjective. Accordingly, the potential risks were arrived at by estimate.

At all risk levels, the guidelines called for the use of biological barriers. Bacterial host cells should be from strains unable to survive in natural environments (outside the test tube). Vectors carrying recombinant DNA, including plasmids , bacteriophages, and other viruses , were to be nontransmissible and unable to survive in natural environments.

For experiments having minimal risk, the guidelines recommended that scientists follow general microbiology safety procedures. These included not eating, drinking, or smoking in the lab; wearing laboratory coats in the work area; and promptly disinfecting contaminated materials.

Low-risk procedures required a bit more caution. For example, procedures producing aerosols, such as using a blender, were to be performed under an enclosed ventilation hood to eliminate the risk of the recombinant DNA being liberated into the air.

Moderate-risk experiments required the use of a laminar flow hood, the wearing of gloves, and the maintenance of negative air pressure in the laboratory. This would ensure that air currents did not carry recombinant DNA out of the laboratory.

Finally, in high-risk experiments, maximum precautions were specified. These included isolation of the laboratory from other areas by air locks, having researchers shower and change their clothing upon leaving the work area, and the incineration of exhaust air from the hoods.

Certain types of experiments were not to be done at all. These most potentially dangerous experiments included the cloning of recombinant DNA from highly pathogenic organisms or DNA containing toxin genes. Also forbidden were experiments involving the production of more than 10 liters of culture using recombinant DNA molecules that might render the products potentially harmful to humans, animals, or plants.

The scientists at the Asilomar conference also resolved to meet annually to re-evaluate the guidelines. As new procedures were developed and safer vectors and bacterial cells became available, it became possible to re-evaluate and relax some of the initially stringent and restrictive safety standards.

See also Recombination; Viral genetics; Viral vectors in gene therapy

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Asilomar Conference

Asilomar Conference

Introduction

History and Scientific Foundations

Impacts and Issues

BIBLIOGRAPHY

Introduction

The Asilomar Conference of 1975 was held to consider the possible biohazards of the then newly developed recombinant DNA technology. This technology involves selectively removing the genetic material (deoxyribonucleic acid or DNA) from one organism and inserting it into the DNA of a different organism. As a result of this recombination, the proteins encoded by the inserted genes are expressed in the host organism.

Following the development of recombinant DNA technology in the mid–1970s, researchers were soon able to successfully transfer DNA into target microorganisms, such as the bacterium Escherichia coli, thus enabling the target organism to produce the protein(s) encoded by the inserted DNA. Almost immediately, the researchers recognized the potential for the deliberate or accidental misuse of this technology to create an organism whose ability to cause disease was enhanced or even created anew.

The researchers took the extraordinary step of declaring a moratorium on recombinant DNA research until they could meet, discuss their concerns, and formulate guidelines to restore confidence in future research. The meeting took place in February 1975 in Asilomar, which is located on the northern coast of California near San Francisco.

History and Scientific Foundations

Recombinant DNA technology had its roots in the 1970 discovery by American microbiologist Hamilton Smith (1931–) of an enzyme dubbed a restriction enzyme. (In the decades that followed dozens of different restriction enzymes have been discovered.) Restriction enzymes function by recognizing a certain sequence (unique to each restriction enzyme) of nucleotides—the building blocks of DNA—and cutting the DNA at that site. The cut is made in such a way that a portion of one of the two nucleotide strands that normally intertwine to form the DNA double helix is exposed. Activity of the restriction enzyme on another segment of DNA produces an exposed portion of the opposite strand. Because the exposed nucleotides on one exposed portion can bind to the corresponding nucleotide on the other exposed strand (the exposed nucleotide sequences are described as being complimentary to each other), segments of DNA from different sources could be made to meld together.

WORDS TO KNOW

DNA: Short for deoxyribonucleic acid, a double helix shaped molecule that is found in almost all living cells and that determines the characteristics of each organism.

RECOMBINANT DNA: DNA that is cut using specific enzymes so that a gene or DNA sequence can be inserted.

RESTRICTION ENZYME: A special type of protein that can recognize and cut DNA at certain sequences of bases to help scientists separate out a specific gene. Restriction enzymes recognize certain sequences of DNA and cleave the DNA at those sites. The enzymes are used to generate fragments of DNA that can be subsequently joined together to create new stretches of DNA.

Following the discovery of restriction enzymes, progress in recombinant DNA technology occurred with astonishing swiftness. In 1972, Paul Berg (1926–) of Stanford University reported the manufacture of recombinant DNA consisting of an oncogene from a human cancer-causing monkey virus ligated (joined) into the genetic material of the bacterial virus lambda. The following year, Stanley Cohen (1935–) and Herbert Boyer (1936–) were successful in transferring foreign DNA into E. coli.

The rapid developments of recombinant DNA technology, combined with Bergs’ demonstration that a potentially-harmful gene could be transferred into a new organism caused great concern. The specter of the malicious design of a deadly microorganism that was capable of person-to-person transmission, and the realization that the technology had outpaced knowledge of its potential pitfalls prompted the moratorium and the Asilomar conference.

Impacts and Issues

In February 1975, the leaders of the international molecular biology community—then just over 100 researchers, in contrast to the hundreds of thousands of molecular biology researchers in 2007—met at the Asilomar conference center in California. The purpose of the gathering was to establish at least a minimal set of guidelines for those engaged in recombinant DNA research. Then, anyone seeking to conduct recombinant DNA research would be required to follow these guidelines (a goal since achieved).

Conference delegates considered all the equipment and laboratory facilities that would be required to perform recombinant DNA research, and the type of research that might be done, to rate the risks of the research as minimal, low, moderate, or high. As the riskiness of the research increased (e.g., the organism being used was a known pathogen), the stringency of the precautions increased. For example, a low-risk research lab would not need any special ventilation, while high-risk research would require a facility designed to contain the organism in the event of a spill or other accident.

This task was very difficult, since guidelines were being formulated to some experiments that had yet to be done. Still, some realistic guidelines emerged. For example, the scientists decided that the bacteria used in the research should be incapable of surviving outside the controlled environment of the lab. This could be achieved by, as one example, genetically crippling the bacteria so that the cells could not make some vital nutrient. As a result, bacterial survival depended on the presence of the nutrient in the artificial food source on which they were grown. In this way, the chance of spread of the recombinant bacteria to the outside world would be extremely remote.

Other risk-related guidelines included a ban on food in a laboratory; wearing of protective gear, including a lab coat, gloves, and face mask; scrupulous clean up of work areas before and after an experiment to make sure surfaces and equipment was free of bacteria; and, at the highest risk level, the design of a laboratory that was self-contained and, as a result, completely separated from the outside world.

The guidelines banned certain types of experiments, such as the use of highly pathogenic organisms or genetic material known to encode a harmful product like a toxin. Then as now, it was recognized that scientists or organizations bent on the deliberate design of harmful organisms would circumvent the guidelines. However, the vast majority of the scientific community supported and have followed the guidelines developed at the Asilomar conference.

RECOMBINANT FIRSTS

In 1972, Paul Berg of Stanford University was the first to create a recombinant DNA molecule. Berg isolated a gene from a human cancer-causing monkey virus, and then ligated (joined) the oncogene into the genome of the bacterial virus lambda. For this and subsequent recombinant DNA studies (which followed a voluntary one-year moratorium from his research while safety issues were addressed), he was awarded the 1980 Nobel Prize in chemistry.

In 1973, Stanley Cohen and Herbert Boyer created the first recombinant DNA organism, by adding recombinant plasmids to E. coli.

Since these firsts, advances in molecular biology techniques, in particular the development of polymerase chain reaction (PCR) techniques, make the construction of recombinant DNA swifter and easier.

IN CONTEXT: REAL-WORLD QUESTIONS

Potential applications of recombinant DNA technology include food crops engineered to produce edible vaccines. This strategy would make vaccination more readily available to children worldwide. Because of their use across many cultures and their ability to adapt to tropical and subtropical environments, bananas have been the object of considerable research effort. Transgenic bananas containing inactivated viruses that normally cause cholera, hepatitis B and diarrhea and transgenic potatoes carrying recombinant vaccines for cholera and intestinal disorders have been developed and evaluated, though their potential use remains controversial and the approach not yet fully accepted.

BIBLIOGRAPHY

Books

Clark, David P. Molecular Biology Made Simple and Fun. 3rd ed. St. Louis: Cache River Press, 2005.

Dale, Jeremy W., and Simon F. Park. Molecular Genetics of Bacteria. New York: John Wiley, 2004.

Periodicals

Berg, Paul., et al. “Summary Statement of the Asilomar Conference on Recombinant DNA Molecules.” Proceedings of the National Academy of Sciences of the United States of America 72 (1975): 1981–1984.

Frederickson, Donald S. “The First Twenty-Five Years After Asilomar.” Perspectives in Biology and Medicine 44 (2001): 170–182.

Brian Hoyle

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Asilomar Conference

ASILOMAR CONFERENCE

In February 1975 an international group of scientists met at the Asilomar Conference Grounds in Pacific Grove, California, to discuss the potential biohazards posed by recombinant DNA (rDNA) technology. The official title of the meeting was the International Conference on Recombinant DNA Molecules, but it is remembered simply as the Asilomar Conference. It established guidelines concerning the physical and biological containment of rDNA organisms that served as the model for the current guidelines used by the National Institutes of Health (NIH). Although the Asilomar Conference marks a watershed moment in the regulation of rDNA technology, its broader implications remain controversial (Barinaga 2000, Davatelis 2000). Some claim that it was an example of self-promotion by a small but powerful interest group. Others argue that the process was too alarmist and generated unfounded fears in the public. Still others contend that it was an instance of scientists successfully regulating their own work.


The Events Preceding Asilomar

The first successful trial of rDNA technology (a type of genetic engineering that involves splicing genes into organisms) was performed by Paul Berg and other researchers at Stanford University in the early 1970s. It quickly raised concerns about "playing God" and the potential biohazards posed by recombinant microorganisms. In an unprecedented call for self-restraint, prominent scientists sent letters to the journal Science calling for a temporary moratorium on rDNA research (Singer and Söll 1973, Berg et al. 1974). Concerns included the development of biological weapons and the potential for genetically engineered organisms to develop resistance to antibiotics or to escape control.

Singer and Söll's letter was the result of a June 1973 meeting of the Gordon Conference on Nucleic Acids. In response, Berg led a committee of the National Academy of Sciences (NAS) in April 1974 to formulate policy recommendations for the use of rDNA technologies. The Berg committee, which met at the Massachusetts Institute of Technology, was composed of leading molecular biologists and biochemists involved in the emerging rDNA field.

This committee produced three recommendations addressed at the scientific community and the NIH: (1) instituting a temporary moratorium on the most dangerous experiments; (2) establishing an NIH advisory committee to develop procedures for minimizing hazards and to draft guidelines for research (which became the Recombinant DNA Advisory Committee [RAC]); and (3) convening the Asilomar Conference. All three recommendations were implemented.


The Conference Itself

Participation in the NIH-sponsored Asilomar Conference was by invitation only. It was attended by 153 participants. Outside of sixteen members of the press and four lawyers, it was composed entirely of scientists, mostly molecular biologists from the United States. There were no representatives from ethics, social science, ecology, epidemiology, or public-interest organizations.

The formal task of the conference was to identify the potential biohazard risks involved with rDNA technology and design measures to minimize them. Yet there was also a more important informal task faced by the participants. The emerging rDNA technology presented novel problems of regulation characterized by vast uncertainties concerning potential environmental and public health threats. The conference was set within a cultural and political context marked by a growing awareness of these threats and an increasing suspicion of new technologies. Therefore, the informal task faced by the scientists was to regulate rDNA technology in such a way that satisfied the public and, most importantly, allowed the science to be self-governing.

A comment made by Berg, cochair of the conference, illustrates this mind-set:

If our recommendations look self-serving, we will run the risk of having standards imposed. We must start high and work down. We can't say that 150 scientists spent four days at Asilomar and all of them agreed that there was a hazard—and they still couldn't come up with a single suggestion. That's telling the government to do it for us. (Wright 2001 [Internet source])

In order to achieve the goal of self-governance, the participating scientists narrowed the agenda such that the issue was defined as a technical problem. The organizers decided not to address ethical concerns but to focus on biohazard issues (Wright 1994). Defining the problem in technical terms legitimated the model of self-government by scientists, because they were the only group that could solve such problems.

The conference organizers shaped a consensus around this technical problem definition. There were, however, threats to consensus from both sides. Some participants were opposed to any type of regulation, because it would compromise their freedom of inquiry. Others wanted a broader agenda that included public input on ethical considerations and explicit bans on the development of biological weapons.

In the end, guidelines with respect to physical and biological containment of rDNA organisms were drafted that allowed the scientific community to police itself under the auspices of the NIH-RAC mechanism. The guidelines involved working with disabled bacteria that could not survive outside the lab and classifying experiments according to the level of containment necessary. They also called for an end to experimentation using known carcinogens, genes that produce toxins, and genes that determine antibiotic resistance. The Asilomar Conference established a general sense that the burden of proof rested with scientists and that they must proceed cautiously until they can show that their research is safe.

The laboratory guidelines also became the international standard for rDNA research (see Löw 1985, Wright 1994). In the United States, the system of self-policing avoided both the chaotic patchwork of local legislation established by community decision-making forums and the legal rigidity, yet political changeability, of federal legislation.


Conference Legacy

There have been changes to the guidelines drafted at Asilomar. The membership and role of the NIH-RAC have been expanded, and containment levels have been lowered for many experiments. More public involvement has been incorporated into decision-making processes, and subsequent Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) rules have ensured that the private sector complies with rDNA guidelines as biotechnology has experienced an increasing corporatization. Despite such developments, the Asilomar Conference established the fundamental institutional mechanisms for decisions about rDNA technologies in the United States. It also heavily influenced rDNA research guidelines developed by other countries. In this sense, the legacy of Asilomar is unequivocal.

Yet in another sense its legacy remains controversial. Participants at Asilomar wrestled with two basic questions: How should the protection of scientific freedom of inquiry be balanced with the protection of the public good? How should decisions about scientific research and its technological applications in society be made, especially in climates of uncertainty? Evaluating the legacy in light of these questions points toward three possible conclusions.

First, it has been argued that the conference represented the use of covert power by special interest groups (Oei 1997). According to this claim, scientists marginalized social and ethical questions in order to legitimize the new rDNA technology and persuade the public that control of this technology is best left to scientists (Wright 1994). The Asilomar Conference is portrayed by external critics as an elitist process with a narrow agenda designed to justify the self-government of science.

Second, there is an internal criticism voiced by some within the scientific community. According to this conclusion, the process of the Asilomar Conference and the controversies over regulation were too alarmist. The conference set the precedent for debates that focus on worst-case scenarios and largely ignore a growing scientific consensus about the safety of many rDNA applications. Increasing public opposition to many types of genetic engineering may prevent beneficial uses of these technologies in agriculture and medicine.

The third conclusion is that, despite its shortcomings, the Asilomar Conference represents an unprecedented exercise of the social conscience of science. For the first time, scientists voluntarily halted their own work until the potential hazards could be assessed (Mitcham 1987). This made it one of the first instances of what came to be known as the "precautionary principle." The Asilomar Conference was a novel attempt to balance scientific self-interest with self-restraint. It has left a legacy that transcends rDNA technology by taking an important step in the process of integrating scientific progress into its environmental and social contexts.


ADAM BRIGGLE

SEE ALSO Genetic Research and Technology; Governance of Science.

BIBLIOGRAPHY

Barinaga, Marcia. (2000). "Asilomar Revisited: Lessons for Today?" Science 287: 1584–1585. Covers a meeting that examined the Asilomar Process twenty-five years later and its implications for contemporary societal issues surrounding rDNA and other technologies.

Berg, Paul; David Baltimore; Herbert Boyer, et al. (1974). "Potential Biohazards of Recombinant DNA Molecules." Science 185: 303. One of the letters that sparked the temporary moratorium.

Davatelis, George N. (2000). "The Asilomar Process: Is It Valid?" Scientist 14(7): 51. Examines a meeting held on the twenty-fifth anniversary of the Asilomar Conference and interprets the usefulness of the Asilomar process for the social regulation of current and future scientific research.

Grobstein, Clifford. (1979). A Double Image of the Double Helix: The Recombinant DNA Debate. San Francisco: Freeman. Surveys the main political and social issues surrounding rDNA science in its infancy.

Löw, Reinhard. (1985). Leben aus dem Labor: Gentechnologie und Verantwortung—Biologie und Moral [Life from the laboratory: Gene technology and responsibility, biology and morality]. Munich: C. Bertelsmann. An introduction to the German discussion on recombinant DNA technology.

Mitcham, Carl. (1987). "Responsibility and Technology: The Expanding Relationship." In Technology and Responsibility, ed. Paul T. Durbin. Dordrecht, Netherlands: Reidel Publishing. A broad treatment of the ethics of science and technology, which covers rDNA and Asilomar on pp. 11–13.

Oei, Hong Lim. (1997). Genes and Politics: The Recombinant DNA Debate. Burke, VA: Chatelaine Press. Explores policy-making processes in the early years of rDNA debates. Outlines three alternative policy processes: technocratic, democratic, and legislative. Offers recommendations for emerging controversies.

Richards, John, ed. (1978). Recombinant DNA: Science, Ethics, and Politics. New York: Academic Press. Contains a good annotated bibliography of primary, first-hand accounts of the Asilomar Conference.

Rogers, Michael. (1977). Biohazard. New York: Knopf. Explores the moral and ethical confrontations over rDNA research. Includes three full sections on the Asilomar Conference with detailed quotations from many top participants.

Singer, Maxine, and Dieter Söll. (1973). "Guidelines for DNA Hybrid Molecules." Science 181: 1114. Outlines the potential benefits and hazards of rDNA technology and propose an NAS committee to study the issue and "recommend specific actions or guidelines should that seem appropriate."

Wade, Nicholas. (1975). "Genetics: Conference Sets Strict Controls to Replace Moratorium." Science 187: 931–935. An eyewitness account of the Asilomar Conference.

Wright, Susan. (1994). Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, 1972–1982. Chicago: University of Chicago Press. Chronicles the response of various groups in the United States and Britain to the emerging genetic engineering technologies, traces the evolution of policies and discourses, and includes a section on the Asilomar Conference and its legacy.


INTERNET RESOURCE

Wright, Susan. (2001). "Legitimating Genetic Engineering," Foundation for the Study of Independent Social Ideas. Available from http://www.biotech-info.net/legitimating.html. Examines the problem definition and the consensus forged at Asilomar and the process of persuading the public. A somewhat cynical interpretation of the self-governance of science.

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