May 16, 1990

Douglas E. Kelly, Ph.D.
Associate Vice President for Biomedical Research
Association of American Medical Colleges
One Dupont Circle N.W.
Washington, D.C. 20036

Dear Dr. Kelly:

Thank you for your inquiry of April 2 concerning the application of the Occupational Safety and Health Administration (OSHA) formaldehyde standard to private medical school personnel (e.g., faculty, graduate teaching assistants, and morgue technicians) working at gross anatomy laboratories.

As you note, OSHA promulgated a standard for formaldehyde in December 1987. This standard addresses employee protection from the health risks associated with formaldehyde exposure. The main health effects are respiratory cancer, dermatitis, sensory irritation (eye, nose, throat) and sensitization. In addition to the inhalation hazard, solutions of formaldehyde (such as the formal in used as a tissue preservative) can damage skin and eye tissue immediately upon contact. For this reason the standard requires effective protective equipment to prevent skin and eye contact, as well as eyewashes and showers if there is the possibility of splashes to eyes and body. There is a wide selection of effective protective equipment available which will prevent skin and eye contact to formaldehyde while allowing for relative comfort and ease of work. Your staff should consult with a safety and health professional to find specific equipment which will meet work requirements and reduce the hazard. Handling and storage procedures might also be modified to eliminate or reduce splash hazards.

As part of the standard development process, OSHA identified the types of establishments using formaldehyde, the levels of exposure, and numbers of employees exposed. Comments and testimony were solicited from all affected groups, and based on this information, the Agency made a determination of whether compliance with all the provisions of the standard are feasible in each of the types of user establishments. Agency economists also projected the costs of compliance. The formaldehyde record contains a good deal of information about control of formaldehyde hazards in histology, pathology and anatomy laboratories, and the agency's conclusion is that control of these hazards is feasible, both technically and economically.

Industrial hygienists and other health and safety experts have indicated that formaldehyde exposures are greatly reduced when ventilation rates exceed 15 room changes per hour. In addition, work practices should be developed that control sources of formaldehyde such as elimination of open containers and utilization of laboratory hoods where work permits. Where dilution ventilation and other measures are not sufficient, downdraft anatomy tables or local exhaust ventilation may be necessary. The National Institute for Occupational Safety and Health (NIOSH) has developed some ventilation designs for embalming tables that may be appropriate for your laboratories. If the use of such controls is infeasible in a particular application, or while controls are being installed, use of respirators is permitted, provided the respiratory protection requirements of the standard (paragraph g) have been met.

Many institutions have instituted effective programs of hazard control, including exposure monitoring, employee training and use of appropriate protective equipment, and are in compliance with the requirements of the formaldehyde standard. It might be valuable to contact other medical schools to obtain information on means of employee protection and hazard control which have been found to be effective.

We hope this information is helpful.

Sincerely,

Gerard F. Scannell
Assistant Secretary

[See also 06/22/90 letter to Douglas E. Kelly.]

April 2, 1990

Mr. Gerard F. Scannell
Assistant Secretary of Labor
Occupational Safety and Health Administration
200 Constitution Avenue
Washington, DC 20021

Dear Mr. Scannell:

Last October, responding to an unidentified complaint concerning formaldehyde fumes, officials from OSHA inspected Howard University College of Medicine human dissection teaching laboratories. While finding no violation of permissible fume standards, OSHA cited the college for other violations of safety standards in the use of hazardous materials (see attached). The College of Medicine must demonstrate compliance with standards for employee safety by April 28, 1990 or face further sanctions which threaten the viability of the teaching program in anatomical sciences.

Compliance in this case does not relate to the welfare of students in the dissection course, but rather all who are regarded as employees - faculty, graduate teaching assistants, and morgue technicians. These individuals would now be required to be garbed in non-permeable rubberized aprons, heavy industrial arm-length gloves, and full face-mask. All containers of formaldehyde, phenol, alcohols, and other embalming ingredients would have to be labeled with warnings, and atmospheric fume levels of formaldehyde (for example) must be maintained below 1 part/million (a standard which has been quadrupled in stringency recently).

These standards have been promulgated primarily with the safety of industrial workers in mind. They are absolutely impossible to observe in the course of laboratory teaching and dissection practiced in one form or another by every medical school in the country.

While some gross anatomy laboratories probably warrant scrutiny and enforced upgrading, the vast majority are carefully controlled, and faculty are sensitive to maintaining clean, respectful, and well-ventilated conditions. There is no firm evidence that faculty, students, or service personnel serving in the normal gross-anatomy laboratory have been affected by the routine exposure to these necessary substances. Unlike industrial employees, these workers are generally exposed intermittently in the course of their duties. No less-toxic, economically feasible alternative methods of preservation have emerged despite persistent exploration for many years. Computerized gross anatomical instruction (the so-called "electronic cadaver") is promising, but probably ten years away due to soft-ware development.

At present, it is unlikely that any medical school in this country, could meet the OSHA criteria and preserve its instructional functions. These functions are absolutely essential and fundamental to medical education. Hence the OSHA standards have the potential of shutting down the medical degree program of any school at which a complaint instigates an inspection.

On behalf of our constituent medical colleges and their faculty, we would appreciate your advice and assistance in finding a resolution to this dilemma. Thank you for taking time to consider this request. We would be pleased to meet with you to examine the matter in more detail.

Sincerely,
Douglas E. Kelly, Ph.D.
Associate Vice President for
Biomedical Research

cc: Dr. Raymond Hayes