June 22, 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:

This is in further response to your letter of May 23, concerning the application of the Occupational Safety and Health Administration's (OSHA) formaldehyde standard, 29 CFR 1910.1048, to private medical school personnel (e.g., faculty, graduate teaching assistants) and morgue technicians working at gross anatomy laboratories.

OSHA relies on information submitted by the public, as well as staff research, when formulating standards. The standard-setting process is designed so that interested parties have ample opportunity to provide initial input, review regulatory proposals, and provide comments. The record of submissions for the formaldehyde standard is quite extensive and contains material on exposures in a variety of settings, including gross anatomy laboratories. Enclosed are two such submissions. One from Dr. Melvin First, an OSHA expert witness, primarily addresses methods of compliance and feasibility of controls. The other is a report of a Health Hazard Evaluation (HHE) or on-site investigation, conducted by the National Institute for Occupational Safety and Health (NIOSH) at the gross anatomy laboratory of the University of Colorado Medical School. This report describes the evaluation methods, the existing conditions, and the recommendations for improvements.

In your mention of the special needs of the technical staff, you have recognized that each function has different hazard potentials and different requirements and that it is reasonable to provide protection accordingly. The formaldehyde standard only requires personal protective equipment (PPE) which is appropriate to the hazards of the operation, based on conditions of use. The level of protection required is limited by the degree of hazard. Dermatitis was one of the conditions noted in the NIOSH HHE section on medical surveillance, and the wearing of gloves is recommended as an effective prevention measure. While rubber gloves are mentioned, butyl and nitrile are the most effective barriers against formaldehyde. A 0.3 mm thickness of these materials resists chemical breakthrough for over 8 hours, and thinner gloves might be adequate for your needs. The newer polyethylene laminate disposable gloves have been tested to provide over 4 hours of effective protection with a thickness of 0.08mm. These materials are also available as aprons and arm coverings. Aprons or laboratory coats made of polyethylene or similar material may also provide effective body splash protection for students and faculty, if a hazard potential exists. If there is no potential for eye splash, based on experience and evaluation of the potential exposure, then eye protection would not be required. If there is splash potential, chemical goggles may provide sufficient protection.

If there is the possibility that formaldehyde can be splashed in the eye or on the body, equipment suitable for flushing contaminated body parts must be provided. If quantities are small or spills are limited to a small area, a full shower may not be necessary. Once again, the hazards in embalming areas may require a greater degree of protection so that showers may be necessary in these areas but not throughout the laboratory.

After reviewing the information provided, if you still feel that the use of PPE is infeasible, then it would be advisable for you to meet with OSHA staff to discuss how employee protection can be achieved. David Smith, Director of Health Compliance Assistance can be reached at 523-8036. You may also want to contact NIOSH. Its Hazard Evaluations and Technical Assistance Branch can be reached at (513) 841-4428.

Sincerely,



Gerard F. Scannell
Assistant Secretary

Enclosures



May 23, 1990

Mr. Gerard F. Scannell
Assistant Secretary for
Occupational Safety and Health
U. S. Department of Labor
200 Constitution Avenue, N. W.
Washington, D.C. 20210

Dear Mr. Scannell:

Thank you for your letter of May 16, 1990 in reply to my inquiry of April 2, 1990. (Copies attached) on behalf of the anatomy instructors in the medical schools of the United States.

The information you provided was not unfamiliar to us and, perhaps due to some lack of clarity in my letter, did not provide a constructive approach toward alleviating a pressing dilemma faced by every medical school in this country (as well as other programs in allied health). Specifically:

1. My letter was written not only on behalf of Howard University (which has been cited), but rather on behalf of the anatomy programs of all 126 medical schools which the AAMC represents. You state that, "Many institutions have instituted effective programs of hazard control," and advise us to, " ... contact other medical schools to obtain information on means of employee protection and hazard control which have been found to be effective." In fact, from numerous direct contacts with the departments and through the Association of Anatomy Chairmen (AAC), we are aware of no medical school that has found a solution to the problem of utilizing the personal protective equipment (heavy protective gloves, aprons, masks, faceshields, etc.) and still being able to perform dissection and instruction in the gross anatomy laboratory. This reality was confirmed at a meeting of the AAC last month. It is this dilemma that poses an insurmountable problem for our medical schools. Your specific advice on this problem would be appreciated.

2. As also confirmed at the AAC meeting, we are not aware of any department of anatomy having been consulted prior to the enactment of the OSHA standard regarding personal protective equipment. Had thorough analysis been made, the conflict between this standard and the teaching function would have been pointed out. It would be helpful if you could indicate the source of expertise on this matter implied in the third paragraph of your letter.

3. We are well aware that high fume levels of formaldehyde have been imputed by some studies to be correlated with respiratory disease, and we regard good ventilation as a reasonable precaution. Many anatomical laboratories have been or are being equipped to provide in excess of 15 room changes per hour and vapor levels lower than 1 part per million. Provision of eye washes and labeling of materials is also not an unreasonable requirement. Showers will probably never be used.

4. Other than eye-splash, we are not aware of reliable evidence that dermal formaldehyde contact, as traditionally occasioned in well operated gross anatomy laboratories, is injurious to humans as implied in the second paragraph of your letter. While it is well-known that the various aldehydes kill and preserve cells and tissues when applied by immersion to small samples or by vascular perfusion to whole bodies, the contact with cornified epithelium which can occur in the course of dissection is better described as an irritant unless an individual has developed an allergic hypersensitivity (which is relatively rare). I have attempted to follow literature on this aspect personally, and have not found evidence that such contact in the teaching setting (as contrasted to industrial scenarios) has been shown to be harmful to human health. Again, it would be helpful if you would provide appropriate references for evidence to the contrary.

5. Relative to economic considerations, it is not unreasonable to require the stipulated personal protective equipment for technical staff who perform embalming and are most at risk for splashing from the agents. Their tasks don't frequently require the digital dexterity and close inspection as compared to dissection and teaching. Outfitting faculty and teaching assistants would not be economically unfeasible, but merely incompatible with their functions. However, what is mandated for faculty and staff must certainly be deemed desirable for students. Thus, even if students and faculty could be perceived as functioning and interacting garbed in personal protective equipment, the cost to outfit an average class of 120-125 students with this disposable gear is a heavy financial burden.

There are, of course, many other aspects of this problem, but perhaps the five alluded to above provide a better insight to the concerns than did my prior letter. I am informed by a former OSHA director that conflicts of this nature with OSHA standards are not uncommon; that it is difficult for OSHA to develop standards that do not have to be compromised in some necessary sector; and that in the past OSHA has stood ready to enter into appropriate dialogue and compromise when dilemmas such as described here have arisen.

We hope that you will be willing to arrange for us to meet with you and appropriate OSHA officials to discuss these matters in more detail. It is essential that our medical schools be advised as to a solution to the problem prior to their embarking upon a new academic year.

Thank you once again for your attention to these concerns.



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

DEK:mw

cc: Dr. Raymond Hayes

Howard University College of Medicine Mr. Isaiah Barnwell Howard University College of Medicine Dr. Robert Petersdorf, AAMC Dr. Thomas Malone, AAMC Mr. Joseph Keyes, AAMC Dr. Cornelius Rosse, President Association of Anatomy Chairmen Dr. Robert Yates, Secretary-Treasurer Association of Anatomy Chairmen American Association of Anatomists

Enclosures



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 formalin 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.



Gerard F. Scannell
Assistant Secretary




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 he 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. Computed gross anatomical instruction (the so-called "electronic cadaver") is promising, but probably ten years away due to software 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

DEK/gjb

cc: Dr. Raymond Hayes

      Mr. Isaiah Barnwell
             Howard University College of Medicine
      Dr. Robert Petersdorf, AAMC
      Dr. Thomas Malone, AAMC
      Mr. Joseph Keyes, AAMC
      Dr. Cornelius Rosse, President
             Association of Anatomy Chairmen
      Dr. Robert Yates, Secretary-Treasurer
             Association of Anatomy Chairmen
             American Association of Anatomists