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OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at

September 13, 1993

Mr. Edward Krisiunas MT (ASCP),
CIC Infection Control Coordinator
Safe Way Disposal Systems
90 Industrial Park Road
Middletown, CT 06457

Dear Mr. Krisiunas:

Thank you for your letter of May 19, requesting interpretation of the Occupational Safety and Health Administrations Formaldehyde Standard (29 CFR 1910.1048). We regret the delay in responding to your inquiry. In your letter you question whether the Formaldehyde Standard requires labeling of the outer containers containing sealed red bags of pathological waste, i.e. tissues and other body parts, that were soaked in Formalin.

OSHA does not regulate the outer shipping container of hazardous material. The hazard warning labeling requirement is only enforced and limited to the actual container holding the hazardous substance, i.e. bottle, bag, can, jar, etc. OSHA has no requirement for hazardous warning labels on the outer shipping container. If the shipping container itself is the actual container holding the hazardous substance then it would have to be labeled in accordance with the requirements of the Formaldehyde Standard.

OSHA's Formaldehyde standard requires employers to assure that a label is affixed to all containers of materials that meet the following requirements: Formaldehyde gas, all mixtures or solutions composed of greater than 0.1% formaldehyde, and materials capable of releasing formaldehyde into the air, under reasonably foreseeable conditions of use, at levels of 0.1 ppm to 0.5 ppm.

These labels shall identify that the product contains formaldehyde, list the name and address of the responsible party, and state that the physical and health hazard information is readily available from the employer and from MSDS. At levels above 0.5 ppm, the label shall include the words "Potential Cancer Hazard" and warn of all other hazards as defined in Appendices A and B of 29 CFR 1910.1200.

Enclosed for your reference are two pamphlets, "Exposure to Hazardous Chemicals in Laboratories" and "Occupational Exposure to Bloodborne Pathogens" which summarize other standards that may be relevant to your work operations

We hope this information is useful to you.


Ruth E. McCully, Director
Office of Health Compliance Assistance

May 19, 1993

Ruth McCulley
Director of Health Compliance Division
U.S. Department of Labor - OSHA
Room N-3469
200 Constitution Avenue, N.W.
Washington, DC 20210

Dear Ms. McCulley:

I am writing to request an interpretation of the Formaldehyde Standard, 1910.1048.

I represent a medical waste disposal company. Periodically our waste disposal facility receives pathological waste, i.e. tissues or other body parts which were soaked in formalin from healthcare facilities. When readied for disposal at the healthcare facility, these items are in containers, devoid of liquid formalin, placed into a red bag, sealed, and subsequently discarded into a cardboard box (per Connecticut Department of Environmental Protection regulations). This box, 4 or 7.5 cubic foot capacity, is sealed with tape and transported to our facility for final disposal. Here, the boxes are manually removed and placed onto a conveyor system, which feeds into an incinerator. Under these conditions does the outside of our container, the "cardboard box" require a label indicating the presence of formalin?

Based upon my knowledge of Department of Transportation and Environmental Protection Agency regulations, this waste would not be constituted as "hazardous". Because these tissues are regulated as medical waste by the State of Connecticut, there are specific packaging and disposal requirements which I briefly alluded to above.

Should you have any additional questions, please contact me at (203) 632-0294. I look forward to your response.


Edward Krisiunas MT (ASCP),
CIC Infection Control Coordinator


cc: Maureen Keeler, Hospital of St. Raphael Phil Radding, Hospital of St. Raphael Martin Smith, Safe Way Disposal Systems