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Is Your Biowaste Recordkeeping Compliant?

In Massachusetts, medical and biological waste is regulated by 105 CMR 480, Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII).

The Sanitary Code requires that all biological waste removed for off-site treatment must be manifested for shipping using a medical waste tracking form.  Waste generators are responsible for confirming that the waste was received by the off-site treatment facility within 30 days of shipment. The signed biowaste manifest (or tracking form) that is returned within 30 days serves as proper documentation.

A copy of all manifests is required to be kept on file for a period of 375 days after the material is accepted by the transporter, although retaining manifests for three years is recommended.

Please keep in mind that maintaining biowaste manifests is not enough! The Sanitary Code also requires that a recordkeeping log be kept for all biological waste. The State has published forms that must be maintained for both off-site waste shipments and on-site treatment.

The recordkeeping log forms must be retained for three years. Logs for off-site treatment need to include the date of each shipment, the type of waste, the total number of containers, and the total combined weight or volume. A copy of all manifests must be kept with the log.

The log book must have on its cover the name of the facility, the name of the owner and operator, if applicable, and in large print the words Medical/Biological Waste Recordkeeping Log. There are other recordkeeping requirements associated with the log book including having SDS for all chemicals used for waste disinfection as well as IBC-related documentation.

It should be noted that biowaste recordkeeping requirements vary by state. For instance, in New York, the Department of Health (DOH) and the Department of Environmental Conservation (DEC) share responsibility for regulated medical waste (RMW) oversight. The DOH oversees regulated medical waste (AKA biowaste) for hospitals, residential health care facilities, diagnostic and treatment centers, and clinical labs. The DEC oversees RMW generated at all facilities outside the DOH jurisdiction, including research laboratories. 

Although there aren’t specific requirements for a recordkeeping log, New York generators of regulated waste must keep a record of how all RMW was managed. For RMW that is shipped off-site, copies of the shipping tracking documents (Copy 1 and Copy 4) must be kept on file for each shipment.

In addition to these requirements, the New York City Department of Sanitation (DSNY) also regulates biological waste at the City level as discussed in a previous blog. To track proper disposal of regulated medical waste, generators must file a Solid Waste Removal Plan with the DSNY annually. The plan must be accompanied by the most recent copy of the company’s biowaste manifest(s).

For additional information about biowaste recordkeeping requirements for your facility, or for assistance implementing them, please email us at [email protected].

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