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Proceedings of the 4th National Symposium on Biosafety
Perspective of the Office for Protection from Research Risk
Nelson Garnett, DVM
OPRR/NIH
OD/OER/OPER/DAW
31 Center Drive MSC 2180
Bethesda, MD 20892-2180
OPRR is certainly very proud to be one of the several sponsors of this exciting symposium. Most of you are aware of the various plagues that have afflicted the government in the last few months. In fact our ability to conduct this very meeting seemed to be in jeopardy in the recent past due to budget uncertainties. Those of us from the Washington area and elsewhere have endured record setting blizzards and floods. In fact, as I was driving out of my dirt road this morning at 4:30 A.M. the river was just coming up over the intersection and I made it out just in time to get to the airport. Fortunately the record setting extreme cold temperatures have temporarily averted the plague of locusts that may have been planned for us next.
Now perhaps of greater interest to this audience, a pre-publication copy of the long awaited revision of the "Guide for the Care and Use of Laboratory Animals" has been released by the Institute of Laboratory Animal Resources (ILAR), and my apologies to ILAR for this slide. From now on the title should read the "ILAR Guide" not the "NIH Guide." That document has been photocopied and is in your meeting materials. Dr. Tom Wolfly, the Executive Director of ILAR will have some comments on the status of the "Guide" after my remarks. I hope he will also speak a little about another document that is very relevant to this symposium, the in press publication entitled Occupational Health & Safety In The Care and Use of Research Animals. Because the Public Health Service embraces the "Guide" by reference and requires that PHS assured institutions base their programs of animal care and use on it, OPRR has issued guidance to assured institutions regarding the "Guide" revision. This guidance is in the form of a "Dear Colleague" letter dated this past Friday, January 26th, and addressed to all Institutional Officials and Chairs of IACUCs at PHS Assured institutions. It is also available to you here today. There's an OPRR table outside in the lobby area and you'll see a handout there. It's on green paper for easy identification.
That letter has three main points, and although it represents OPRR guidance to PHS supported institutions, the letter has been reviewed and endorsed by our counterparts at USDA. We included the Veteran's Administration and FDA and NCRR in that discussion as well. That letter has three main points. One is the fact that there is a pre-publication copy of the 1996 "Guide." Two is that until the 1996 "Guide" is actually published in its final form the 1985 "Guide" will remain the official "Guide" for the purposes of PHS policy implementation. I don't really know when that final publication will occur. Perhaps Dr. Wolfle may have some insights on that in a little bit. And three, the PHS Policy requires that assured institutions base their programs on the "Guide" and be in compliance with the USDA regulations. The pre-publication copy of the 1996 "Guide" differs from the current USDA regulations in some respects. PHS Assured institutions are reminded that compliance with the USDA regulations is an absolute requirement of the PHS Policy.
The title of my talk is Perspective of the Office for Protection from Research Risk. I think its always useful to look at these issues from a variety of perspectives, which reminds me of a story about our CDC host Dr. Jonathan Richmond. You see Jonathan was a young safety officer at NIH when I was a laboratory animal veterinarian at the NIH research farm. He thought it was particularly unusual that I had not reported any reportable accidents during the preceding year. One day Jonathan came out to the farm to find out if I was telling the truth about my perfect safety record. He asked me point blank if I had ever had any accidents while working on the NIH research farm. I thought about it a minute and replied: "well no, but that old antibody producer mule did kick in two of my ribs a few weeks ago." "Great Scott", said Jonathan, "don't you consider that an accident. You really should have reported that." I scratched my head for a second and said "Hell Jon, I could have sworn he did it on purpose!" So you see, sometimes it pays to consider the animal's perspective as well.
In preparing for this talk one of the first questions I had to ask was "What is the PHS Policy basis for OPRR's interest in occupational safety?" The Health Research Extension Act of 1985 is completely silent on the occupational safety question. PHS Policy language is also very limited under the institutional program of animal care and use. The program description that's required to be in the institutional assurance document must include a description of the health program for personnel who work in laboratory animal facilities or have frequent contact with animals.
Further instruction is gained from the sample Assurance language in the PHS Policy which asks that you describe the institution's occupational health program, including the frequency of tuberculosis testing if any, requirements for medical examinations, etc., and the institutions may submit a memorandum or pamphlet which informs animal care and use staff of institutional policies regarding health screening or tests. It is mainly by reference to the "Guide" that the occupational safety expectations of the PHS policy are flushed out. In the 1985 "Guide", occupational safety is covered under several different headings in at least three chapters, including Institutional Policies, Laboratory Animal Husbandry and Special Considerations. The term "substantial animal contact" was introduced to describe those people who need to be included in the institutional safety program. Realizing that the biomedical research community might not know what is meant by this term, a group of us pointy-headed bureaucrats got together to try to define it for you. We decided that anybody who works with these guys [slide of elephant] as substantial animal contact.
The pre-publication copy of the 96 "Guide" has been reorganized to incorporate most safety elements under one separate heading, Occupational Health and Safety of Personnel. I'm only going to describe briefly the subheadings and contents because these topics obviously will be dealt with extensively throughout the course of this meeting. One point that I think is very important in the introductory paragraph of this section is that the responsibility for the overall safety of the work place is shared by all levels, from the administration all the way down, and that it relies at least in part on individual accountability. Hazard identification and risk assessment require qualified professional staff. Risk intrinsic to the work environment should be identified and should be reduced to acceptable levels. The extent and level of employee participation in the program should be based on the actual hazards imposed and on the exposure intensity, duration, frequency, employee susceptibility, and work place history. Personnel at risk should have clearly defined duties and procedures and should understand the hazards involved. They should be proficient in implementing the required safeguards. Training should be as appropriate to the risk imposed by their work place. It is essential that all personnel maintain a high standard of personal hygiene. Suitable clothing including protective clothing and laundry services should be institutionally provided. Outer garments worn in animal rooms should not be worn outside the facility and eating, drinking, smoking, and application of cosmetics should not permitted in animal rooms. Washing and shower facilities should be provided as appropriate and facilities, equipment and procedures should be designed to reduce physical injury to personnel.
Exposure monitoring is crucial as are the proper maintenance and calibration of safety equipment. Readers are referred to the CDC/NIH publication "Biosafety in Microbiological and Biomedical Laboratories. Specific subjects including policies, equipment, practices, disposal, oversight, anesthetic deaths, scavenging, cross contamination are covered. In general, safety depends on trained personnel who rigorously follow safe practices. Personal protective equipment appropriate to the various environments should be provided as needed. Other considerations include input from health professionals concerning issues like employee confidentiality and the availability of immunization. The 1985 recommendations on serum collection and storage have been modified on the basis of ten years experience. It is now recommended only under limited circumstances. Zoonoses surveillance is recommended and special attention is focused on tuberculosis screening in non-human primate bite management.
This discussion would not be complete without some mention of "performance" standards. OPRR, AAALAC, USDA and the majority of the scientific community have expressed a strong preference for "performance-based" standards over rigid and inflexible "design" or "engineering" standards wherever possible. This approach provides the necessary flexibility to meet the unique institutional settings and research goals of this diverse community, while allowing for evolutionary improvements in the health and well being of animals as new knowledge and innovation is applied to their care and use. The same concept is applicable to the occupational health and safety issues that we are here to discuss. While agreeing wholeheartedly that this is the best approach, I also believe that it takes a far greater commitment to get it right. I know this does not apply to anyone attending this symposium but, it is still possible to find individuals and institutions who seek to do the very least that they can get by with, the "show me where it says I have to do that" set. I submit that the minimalist approach is much more compatible with the rigid "design" standards that we all work so hard to avoid.
I also believe that it's impossible to have it both ways. Here's something for you to take homewith you, and I think it applies to your occupational safety program as well as to the rest of your animal care and use program. In theory, there should be nothing that OPRR or USDA or AAALAC can find in your facility that you don't already know about. I know there's a practical limitation to that statement, based on the different expertise of the site visitors for example, or the unpredictability of the day-to-day operations. However, you are in a far better position to really know what is going on than any outside evaluator. Why is it important that you find your own problems first?
One reason is that you will have the first shot at fixing it your way, before someone else finds it and imposes their idea of what's best for your facility. To the best of my knowledge, all three regulatory and accrediting agencies will generally respect your reasonable and specific plans and schedules to correct deficiencies that your IACUC identifies in its semi-annual review.
I'd like to close now with this final thought and hopefully another take home message from this symposium. The secret to success in this business is a self-monitoring, self-correcting and self-sustaining program.
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Last Modified: 1/2/97
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