November 21, 1994

[Name Withheld]

Dear [Name Withheld]:

This is a response to your letter of August 21, 1993, concerning the Occupational Safety and Health Administration's (OSHA) Hazard Communication Standard (HCS), 29 CFR 1910.1200, as it relates to the guidelines described in OSHA's 1986 publication regarding disposal of hospital wastes contaminated with cytotoxic drugs. The questions in your letter also relate to the requirements under OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030. Please accept my regret for the long delay in responding to your letter. We are providing responses to your questions in the order presented in your letter.

1. Is [the requirement to dispose of cytotoxic waste in distinctively labelled and color-coded bags] designed to comply with the Hazard Communication Standard so that employees can define the appropriate hazard and handle the waste appropriately?

No. Although the requirements of the HCS do apply to the storage and handling of parenteral cytotoxic pharmaceuticals, the HCS does not address proper disposal of hazardous materials and does not apply to hazardous waste. The guidelines in OSHA's 1986 document are intended to address the safety and health of workers handling cytotoxic waste while meeting the disposal requirements of EPA's National Hazardous Waste Program and equivalent state laws.

2. [Is the requirement to place] needles, syringes, and breakable or sharp items used with cytotoxic drugs...in specially designated puncture proof boxes...designed to comply with the Hazard Communication Standard?

Please refer to question number 1.

3. [Could] items that are considered "empty"...or "residually contaminated" with cytotoxic drugs [by definition under RCRA]...be placed in a regular sharps container...that is used for infectious waste?

Yes. OSHA promulgated the Bloodborne Pathogens rule after the publication of the 1986 document on safe handling practices for cytotoxic drugs. For needles, syringes, or other sharps that are contaminated with blood or Other Potentially Infectious Material (OPIM), but only residually contaminated with cytotoxic drugs, puncture-resistant receptacles meeting the requirements of the Bloodborne Pathogens standard must be used.

4. Can empty IV bags and tubing or gowns and gloves used...be placed in with infectious waste as these are only residually contaminated? If not, do they need to be placed in specially labelled and color-coded bags or containers?

OSHA's Bloodborne Pathogens Standard permits disposing of residually contaminated protective clothing with infectious waste, so long as such waste was labelled in accordance with 29 CFR 1910.1030. In lieu of labeling, such waste may be placed in red bags or red containers. OSHA's Hazard Communication Standard would not apply to the labeling of non-infectious waste that is contaminated with cytotoxic residues. Of course, disposal of material contaminated with cytotoxic chemicals must conform to state law. Please refer to the Medical Waste/RCRA Hotline for the State of Illinois; the hotline number is (217) 782-6760.

5. If a hospital segregates true chemical/hazardous chemotherapy wastes such as vials with greater than 3% or the original medication remaining, or mixed infusion bags that were partially given, would only these items need to be handled in a different manner?

Yes. Items defined as "empty" or "residually contaminated" under RCRA or applicable state law do not require handling as described in OSHA's 1986 protocols for handling cytotoxic wastes.

6. Is it necessary to use...the above mentioned bags or containers for the segregation of residually contaminated cytotoxic waste?

No. As discussed above, residually contaminated items may be disposed of in receptacles meeting the requirements of OSHA's Bloodborne Pathogens Standard. Sharps that are residually contaminated may be disposed of in sharps containers meeting the requirements of 1910.1030, and other residually contaminated items may be disposed of in containers that conform to 1910.1030.

We hope this information is helpful. If you have any further questions, please contact the Illinois Medical Waste/RCRA Hotline at (217) 782-6760.

Sincerely,

Ruth McCully, Director Office of Health Compliance Assistance