4th National Symposium on Biosafety

Symposium Keynote: Practicing Safe Science in Animal Research

W. Emmett Barkley, PhD
Howard Hughes Medical Institute
4000 Jones Bridge Road
Chevy Chase, MD 20815
301-215-8825 (8828)

This morning I want to talk a bit about the ILAR committee on health and safety, and share with you its vision and some of the consensus positions that have evolved over time out of the deliberations of this committee. First, I'd like to say that the goal of our committee on occupational health and safety is in fact the vision of this symposium -- safe and reproducible research, healthy animals, healthy people. The committee's intent and motivation, like the mission of this symposium, is to promote the practice of safe science.

Many people over the last two years have contributed to the work of the committee. The consensus positions are, in fact, the composite views of the insight, deliberations and the helpful guidance that we received from all over the country. I will focus on the fundamental concepts that lay the foundation on which the health and safety of all individuals who care for and use research animals can be achieved.

But first, I would like to share a recent experience of the Howard Hughes Medical Institute as background. Some of you know that the title Practicing Safe Science is also the title of a safety training video produced by the Institute in 1993 and distributed widely. I'm pleased to report that it has received high acclaim from a number of groups and organizations, but particularly from scientists, health and safety professionals, administrators, educators and regulators. In fact, it has received acclaim from groups that we must all depend upon to promote and achieve health and safety among those who care for and use research animals. To me the elements of that success come from the core of what we're talking about today and during the remainder of this symposium. It is also what we have been talking about in the deliberations of our committee.

The training video was planned initially with the expressed commitment and support of management. The concepts presented in the video were based on an actual assessment of work place injuries and illnesses within the Hughes Institute. Scientists, technicians, and health and safety professionals all as a collaborative team conceived of how the information was to be presented. Great emphases were placed on the practices that were relevant to the work that was being don at that time. There was a scientific basis for every concept, idea, and practice that was presented. The video drew upon the communication skills of scientists to communicate information to their colleagues. It was, in fact, a cooperative venture from the very beginning. As a result, the finished video is of benefit for the very community that shared in its development.

In many ways this process of collaboration, discussion, risking, and considering points-of-view from other prospectives is the same process that was followed by the ILAR committee. We tried to reflect the wisdom of a collective community. And in doing so, we dealt with issues that many times were very, very difficult but which were always rooted in the same common commitment -- protecting the health and safety of people through relevant and understandable means.

I would like to share with you my view of the consensus developing from the discussions of the ILAR committee and the ideas that were brought to us by so many people.

Institutions should initiate a concerted effort to identify work place hazards and reduce to acceptable levels risks of occupational injury and illness associated with the care and use of research animals. For this to happen, certain things are required. A collaborative effort among all those who participate in and contribute to and who will benefit from a health and safety program must be secured. In terms of research animals, there are five communities that are equally involved: the research community, the institution'senvironmental health and safety professionals, the occupational health component of the organization, individuals involved in providing leadership and technical support for animal care and use, and the institution's management and administration.

This initial collaboration is not sufficient in itself. There must be a mechanism to foster sustained interaction among these groups because health and safety is a continuing responsibility of each of us. Many people with whom the ILAR committee spoke felt that the institutional committees for the care and use of animals are an important vehicle for securing a continuing interaction.

Institutional commitment and delegation of authority are essential elements of a successful occupational health and safety program. This requires that the senior official of the institution demonstrate a personal commitment to a safe and healthful environment, delegate clearly defined duties to those with authority to commit and direct institutional resources, and establish mechanisms for monitoring the success of the program. These three functions cannot be carried out by any head or person or program among the five communities that I spoke of in the first slide. They must come from the senior official. Paramount to this is the need to delegate responsibility and authority to commit resources. This cannot come from the bottom up -- it must come from the top down.

Risk assessment should be a dynamic and continuing process. The assessment process requires a multi-disciplinary approach. Clearly, scientists who are involved in the conduct of research and the planning of that research are instrumental to the process. But, it must also involve health and safety, and it must involve management, and it must involve those who are responsible for the day-to-day care and use of animals. It is a process and an approach in which all need to collaborate and bring about.

There must be defined criteria if a process, a risk assessment, is in fat to be achieved. We believe that this requires the careful identification of the hazards that relate to the nature of the animals as well as the research in which the animals will be involved. These hazards are not limited to biological hazards but cover the gamut of exposure potentials present in our facilities. We need to understand the frequency of exposure to these hazards and we need to understand the intensity of the exposure. Is it something like tuberculosis where a single organism can induce infection, or is it something that we can be exposed to on a routine basis without much concern for the impact on our health and safety?

Susceptibility of employees is an important parameter in risk assessment as is an understanding of the availability and efficacy of the safeguards that protect employees from these hazards. Occupational health histories are perhaps one of the finest sources of true legitimate information that can lead us to a better understanding of the hazards of the workplace. Regulatory requirements, whether or not they reflect good sense and what is really true about the hazards, need to be faithfully and morally adhered to.

A vision that evolved in our discussions was also conveyed in a statement of willingness to adapt to changing circumstances. Many programs adopt standards that are appropriate for certain lines of research that then remain standards for all research that follows. Indeed change is a part of the scientific process and our standards and our practices and our concepts for safety must reflect the relevance of the work that we do. The dynamic process of risk assessment can help guide us to meet these changing circumstances.

Everyone with whom the ILAR committee spoke felt that there is a limitation set on health and safety programs if, in fact, they face only the regulatory responsibility of protecting the safety of employees of our employers. It is the view of those that contributed to the work of our committee that students, visiting scientists, volunteers and other non-employees can be exposed to substantial risks of occupational injury and illness and should be included in the occupational health and safety program.

A more practical level of discussion that we were charged to explore by those who sponsored the ILAR project was the question of substantial contact. A consensus view was that substantial contact with research animals is not a sufficient indicator of the need for occupational medicine or health care services. The need for these services should be based on the nature of hazards associated with the care and use of research animals, the intensity and frequency of the employee exposure and the findings of the risk assessment process.

Health and safety programs require a much broader perspective than a mandate to pursue an objective on just a single criterion. The committee also addressed concerns about serum collection and physical examinations and concluded with the help of those who guided us that serum collection and storage programs and physical examinations are not helpful or cost-effective in protecting the health and safety of most employees who have contact with research animals. The first statement that follows [on this slide] is consistent with the guidance provided in the NIH/CDC document on microbiological safety. Serum collection and storage should be considered as a surveillance tool only for employees who have substantial risk of an occupational infection with an agent that can be monitored serologically. A careful history based on a knowledge of work place risks should be the principle surveillance ool for periodic health evaluations. Physical examinations should be reserved for when symptoms of work-related illnesses are presented during episodic health evaluations. Understanding the knowledge that comes from work place assessments and histories of work-related illnesses can give us clear and supportive guidance for programs of this nature in the future.

These concepts do not provide in themselves specific instructions on the practice of safe science. They are the foundation on which such practices will evolve. They convey a sense that collaboration and cooperativeness, scientific bases and working together can forge practices that are relevant, accepted and successful in carrying out safety in the care and use of research animals.

This conference in itself is an exciting prelude for the future. I've noted that the organizational content and style in which you will be working over the next three days is clearly consistent with the concepts of collaboration -- hearing differing points-of-view, and working with them. This is a successful strategy for promoting health and safety, for practicing safe science, and for improving the health and safety of those who care for and use research animals.

I hope that the spirit of this meeting will nurture and guide our collective work and that we all may return to our institutions having benefitted from this experience. Thank you.

DR. RICHMOND: Dr. Barkley has agreed to entertain any questions that you may have. If we can have some lights up and perhaps put our spotlights down a little bit so we can see the hands. If you do have questions please use a microphone so that we can hear you and get your questions.

MAN: Emmett perhaps your last slide dealt with the issue of serumbanking and we had talked about that briefly yesterday perhaps you could elaborate a little bit on the thinking that went behind the recommendations that you're coming out with because I know a lot of investigators, a lot of institutions believe that the serum banking is critical, its important and I'd just like to have some more comments on that if you don't mind.

DR. BARKLEY: There's been a great deal of experience among many institutions which have developed serum banking programs to provide what is viewed as a future resource for evaluating hazards that may be associated with risks that have not been well defined. It has been found that these programs accumulated much sera but very little wisdom, and less wisdom seems to be a corollary to higher expense.

I can recall a personal experience in the National Cancer Institute when it embarked upon a program to evaluate the viral etiology of cancer. Seven years into that program, and this was in the early 1970s, there was a 150,000 dollar cost of just maintaining the liquid nitrogen tanks to accumulate this resource. It proved to be of little value. There were those who said that it was a valuable resource because of all the sera that we had. But, we quickly found that we could not use it as a research tool because it had been intended purely for a serum collection program. Others have had similar experience. I think it was the NCI experience that guided the development of the NIH/CDC recommendations that one needs to have a clear purpose when collecting serum. And it is something that ought not to be thought of as a future value; it should be something that provides input to assessing the health of workers at the time. That implies that:

This practice was seldom done. There is value I think in collection of a baseline sera when one is working with biological organisms for which one can do an assessment. But in serum programs perhaps the most value that we see is to take a post exposure sample when one is known to be exposed to an agent for which there is some serological basis for evaluation and then a sample after that to help in the management of the exposure.

So, I think this was some of the thinking that occurred. But, I will point out again that this was a consensus view. There are still many who strongly believe that banking a sera and periodic collection even without a commitment of actual testing has some merit. Our consensus view is that this position is costly to implement, and one is likely to be forced to reassess it when the economics of continuing the practice can no longer be justified.

DR. RICHMOND: As we mentioned yesterday one of the key issues associated with serum banking and testing is the development of an informed consent that is necessary in our legal structure today. I think maybe one of the reasons why all of those stored serums at the NIH could not have been used for research purposes was the need to go back and contact everybody and get a conformed consent at the point. Anyway that's an interesting topic. It will be brought up and discussed some more during this symposium.

Office of Health and Safety, Centers for Disease Control and Prevention, 1600 Clifton Road N.E., Mail Stop F05 Atlanta, Georgia 30333, USA Last Modified: 1/2/97
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Symposium Keynote: Practicing Safe Science in Animal Research