4th National Symposium on Biosafety

Chemical Management in Research Animal Facilities

James Romano, LTC, MS, PhD
Chief, Drug Assessment Division
HQ: Medical Research & Material Command
Attn: MCMR-PLD
Ft. Detrick, MD 21702-5014

Abstract

The safe conduct of research in a chemical surety facility is assured by a systematic process of administrative and work control practices. The chemicals studied in such a facility are hazardous. The strategy for assuring the safety of workers in the facility is presented. The "cardinal rule" is to limit potential exposure to a minimum. Practices to assure minimal exposure include:

SAFETY AND RESEARCH MANAGEMENT IN A CHEMICAL CONTAINMENT AREA

The Medical Chemical and Biological Defense Research Program has concerns not only with the area of Chemical Surety Operations but alsohas concerns regarding Biosafety and Containment. The program operates at five US Army medical research laboratories, one DOD laboratory, and approximately 50+ contract sites. It experiences rigorous inspection and review by HQ, MRMC, HQ, DA and other agencies to include the Congressional watchdog agency, the GAO. It has had a remarkable safety record and today I am going to concentrate on those fundamental administrative and work control practices which have been developed to assure safe operations.

Mission

The mission of the Medical Chemical Defense Research program is the timely provision of medical countermeasures to chemical warfare agents which have the potential to be used against US Armed Forces. In practical terms, this mission often implies the development of pharmaceutical items to be carried by the service member or the front-line medic.The lead laboratory for the Medical Chemical Defense Research Program is the USAMRICD located at the Edgewood Area of the Aberdeen Proving Ground, MD.

Background

The practices carried out by researchers in the medical chemical defense component of the program are generally derived from public law, DOD and Army regulation, and local regulations, policies and SOPs. An example of Public Law is Title 50 USC. A sampling of the major source documents is represented in the accompanying table.

The ultimate goals of the documents are to provide a safe workplace, protect the environment, and assure public confidence in the program. Most documents lay out a general framework of safety policies and procedures in which to operate. The documents move from the general to the specific as one moves from AR -> PAM -> Memo -> SOP.

The cardinal rule in all chemical surety and related operations is to "limit the potential exposure to a minimum number of personnel, for a minimum period of time, to a minimum amount of chemical agent, consistent with safe and efficient operations."

The cardinal rule of minimizing exposure is followed through a number of strategies – to include devlopment of restricted areas, access control rosters and entry control procedures, and coordination of operations. The proponent determines the entry rosters, within the spirit of the cardinal rule .

Furthermore, there are also developed levels of hazard – surety operations vs. operations involving dilute surety materials. Safety practices are not very much different between the two levels, the differences between these two situations are in the areas of security and personnel reliability. The focus of this paper is those safety practices common to all operations. The fundamental contention of this paper is that a system of administrative and work control practices, reasonably developed, can provide the basis for a remarkably safe operation.

Administrative and Work Control Procedures

As stated above, the first step in achieving the cardinal rule is access and entry control. Management of the containment area is a matter of entry or access control, area management, and facilities management. Area managment is supported by the fact that all research is carried out under an approved protocol. Deviations from protocols without institutional approval are not authorized. This restriction applies to deviations from animal care and testing procedures, as well as laboratory practices, data management, and safety/response procedures. The proponent sponsors research in the chemical containment area and is responsible for the research performed therein. Area management and facilities management are supported by the following administrative and work control procedures:

Risk Assessment – Each operation is evaluated to determine the safety precautions and Personal Protective Equipment (PPE) required.

Job Hazard Analysis - Similar to Risk Assessment in the case of small-scale R&D operations, production,process, and control measures are evaluated, usually in an industrial type operation.

An example of how risk assessment/hazard analysis would take place in agent operations is as follows:

Hazards from mustard agents are through vapor contact with the eyes and/or respiratory tract and liquid contact with the skin. Mustard vapor may be absorbed readily through the respiratory tract and eyes and ingested through the GI tract.

The hazard from G agents is primarily that of vapor inhalation through the respiratory tract although it may be absorbed through eyes or skin. As liquids, they are hazardous by skin or eye contact and by ingestion. They are highly toxic and quick acting. The hazard from VX is primarily that of liquid absorption through the skin although it may be readily absorbed as a vapor or aerosol through the respiratory tract and eyes and ingested through the GI tract.

The risk assessment developed as a result of the unique hazard and the safety and occupational health standards conntained in ARs and DA PAMs will be used to develop procedures for each agent.

PPE – A matrix of possible levels of PPE exists, and covers the gamut from Level A through Level F, where A is fully encapsulated with butyl rubber suit and supplied air and F is street clothes with mask at hand. Laboratory work takes place in Level E, which means lab coat, appropriate gloves, eye protection, mask at hand and so on. Safety shoes are worn more in deference to common lab hazards such as animal cage racks, etc. Guidance for use, maintenance, care, decon, testing, and disposal of PPE is normally provided as part of training and perhaps in SOPs. The level of PPE is scaled to the level and type of research operation, e.g., nerve versus blister, dilute versus neat materials.

SOPs – SOPs will be prepared in advance of operations and will be in sufficient detail to outline the necessary safety and operational requirements, they are reviewed annually and practiced regularly. SOPs contain routine and emergency actions, locations of emergency equipment and supplies, etc. These SOPs address the handling of chemical surety materials within the framework of the research operation, e.g., pipette disposal, animal injection or exposure.

Recurrent Training – Training occurs prior to operations and on a recurrent basis. It involves all personnel, including researchers, technicians, first responders, etc. Prior training includes:

On a recurring basis training involves first aid and CPR, emergency procedures, and decon procedures. Traing must recur on a minimum of an annual basis.

Emergency Preparedness – Medical procedures, decon procedures, evacuation procedures are all practiced and inspected. These drills also involve, on a periodic basis, any necessary support personnel.

Medical Surveillance – Preplacement, periodic, and termination physical exams are performed on all employees assigned to agent operations. Perhaps the prime example of medical surveillance is ChE monitoring in workers to warn against potential exposure to nerve agents.

Hazard Labelling – Rooms, equipment, tools, etc are marked or tagged (rooms are color coded). Transport containers and vehicles are clearly marked. Each inner and outer container of chemical agents will be labelled with at least the following information:

Disposal Controls – This item refers heavily to decontamination procedures and procedures for verifying decontamination of agent. For the most part, in research operations, checking by analytical methods for residual contamination, after detoxification of agent is not necessary if the agent is known to be in solution, appropriate decontaminants are used in calculated excessive amounts, and the time allowed for reaction exceeds many half-lives. Note: Laboratory animals injected with or ingesting agent are not considered contaminated unless massive doses relative to the animal s mass are given. Other exposed animals require decontamination. Preferred method for destruction of chemical agents is burning, but in containment facilities we use chemical neutralizaion. Disposal, of course, cannot violate Federal, state, or local statute.

Maintenance Controls – Continuous program for equipment and facility maintenance will be implemented and documented; periodic testing of emergency backup systems is required (with documentation).

Summary

The safe conduct of research in a chemical surety facility is assured by a systematic process of administrative and work control practices. The chemicals studied in such a facility are hazardous. The strategy for assuring the safety of workers in the facility was presented. The fundamental contention of this paper was that a system of administrative and work control practices, reasonably developed, can provide the basis for a remarkably safe operation.

References

Army Field Manual 8-285, Treatment of Chemical Agent Casualties and Conventional Military Injuries.

Department of the Army Pamphlet 50-6, Chemical Accident or Incident Response and Assistance (CAIRA) Operations.

Department of the Army Pamphlet 385-61, Toxic Chemical Agent Safety Standards.

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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