August 28, 1995

David L. Trimble, President
Milieu Systems Corporation
1632 Enterprise Parkway
Twinsburg, OH 44087

Dear Mr. Trimble:

This is in further response to your letter of June 20, 1995 concerning interpretation of the Bloodborne Pathogens Standard, 29 CFR 1910.1030, and your request for confirmation that your product label complies with paragraph 1910.1030(g)(1)(i) of the standard.

Regarding your request for an interpretation of the Bloodborne Pathogens standard, you asked "...at what point during the discharge process... (of blood or other potentially infectious materials into sanitary sewers)... has the blood become so dilute that OSHA would not longer consider it to be... (a regulated waste)?" This issue is addressed in the definitions established in paragraph (b) of the standard for both "regulated waste" and "other potentially infectious materials (OPIM)."

Understanding that water, urine, feces, and other reasonably anticipated biological components comprising human wastes in sewage are not included in the definition of "other potentially infectious materials" unless "...visibly contaminated with blood...," sewage would not meet the definition of "regulated waste" under most circumstances. OSHA, therefore, while recognizing that contact with raw sewage poses a number of health hazards, does not consider generally that contact with diluted raw sewage (e.g. not originating directly from a health care facility or other source of bulk blood or OPIM) to be related to bloodborne pathogens.

It is, however, an employer's responsibility to determine which, if any, employees have "occupational exposure" and are covered under the standard. Occupational exposure is defined as reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM that may result from the performance of an employee's duties. While trades such as plumbers, pipefitters, and others who may at times be engaged in maintenance activities are not generally considered to have occupational exposure as defined by the standard, it is the employer's responsibility to determine which job classifications or specific tasks and procedures may place employees at risk. For example, plumbers performing repairs on pipes or drains in laboratories, operating rooms, or mortuaries may have occupational exposure to blood or OPIM. If OSHA determines, on a case-by-case basis, that sufficient evidence of reasonably anticipated exposure exists, the employer will be held responsible for providing the protections of the standard to employees with occupational exposure.

With respect to your request for confirmation that your product label "...complies with the OSHA Bloodborne Pathogens Rule...," the requirements for labeling regulated waste under the Bloodborne Pathogens standard are rather straightforward. Paragraph 1910.1030(g)(1)(i) requires that such labels include the "Biohazard" symbol and legend, as illustrated in the standard, and they are "fluorescent orange or orange-red, or predominantly so, with lettering and symbols in a contrasting color." The agency does not, however, approve or endorse products or labels as you have requested.

The final determination of compliance with OSHA's standards must ultimately take into account all factors pertaining to the use of such devices at a particular worksite with respect to employee safety and health. This must include an evaluation, through direct observation of employee work practices and all conditions of use in the workplace, as well as an evaluation of the equipment or devices alone. Employers purchasing your product, therefore, have the ultimate duty to assure appropriate labeling for the protection of their employees. They have, for example, the responsibility to replace a label in the event an original label may become removed, damaged, defaced, or obliterated to the point that it is not legible.

Your letter did not mention whether or not your device has received clearance from the Food and Drug Administration (FDA) for marketing. If not, please be advised the FDA must clear your product before it can be legally marketed if it is a "medical device" as defined in their regulations. It is our understanding that the FDA plans to consider employee safety and health in its evaluation of products submitted for marketing clearance.

We hope this information satisfactorily addresses your concerns. Thank you for your interest in occupational safety and health.

Sincerely,

Ruth E. McCully, Director
[Office of Health Enforcement]

[Corrected 9/11/2004]