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The United States Environmental Agency (“EPA”) released December 19, 2019 interpretive guidance titled:

Manifesting Non-Creditable Hazardous Waste Pharmaceuticals – New Four Character Code (“Guidance”)

The document was transmitted from Barnes Johnson, Director, Office of Resource Conservation and Recovery to Land, Chemicals and Redevelopment Division Directors, EPA Regions 1-10.

The Guidance addresses the hazardous waste codes/hazardous waste numbers that health care facilities are required to utilize under Subpart P in Part 266. Part 266 is the section of the Resource Conservation and Recovery Act (“RCRA”) that encompasses the management standards for hazardous waste pharmaceuticals.

Subpart P requires that health care facilities use a manifest when shipping non-creditable hazardous waste pharmaceuticals to a RCRA designated facility. A RCRA designated facility includes a permitted or interim status treatment, storage, or disposal facility.

Health care facilities are stated to not be required to include all applicable hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of the manifest. The Guidance further notes that:

. . . In lieu of the waste codes, a healthcare facility must include the word "PHARMS" in Item 13 of the manifest. Citing § 266.502(a)(2)(ii).

The Guidance also cites the preamble to the previously referenced final rule (84 Fed. Reg. 5816) and states:

. . . we used six characters because the eManifest system can accommodate six characters, and because PHARMS communicates the nature of the waste. However, since the final rule was published, EPA has become aware of two issues related to using six characters.

The issues are stated to include:

• Although the e-Manifest system can accommodate six characters and PHARMS can be selected from a prepopulated menu within thee-Manifest system, most generators are currently using paper manifests, not electronic manifests (making it difficult to fit the entire PHARMS code in the box without going over the line.
• Some states and industry stakeholders have told EPA that their databases are not designed to accommodate six characters (rendering it difficult to exchange data with EPA's e-Manifest system).

EPA is therefore requesting that in Indian Country, territories and non-authorized states (as well as authorized states that have adopted the final rule) that healthcare facilities be encouraged to use the four-character code PHRM on both paper manifests and electronic manifests when shipping non-creditable hazardous waste pharmaceuticals under Subpart P.

EPA also notes that it does not object if healthcare facilities or their vendors include RCRA hazardous waste codes on manifests in addition to the PHRM/PHARMS. This is deemed to be a potential help to receiving facilities for better understanding the waste and determining the best course of management. Also recommended for manifested non-creditable hazardous waste pharmaceuticals shipped from a healthcare facility operating in Subpart P (but passing through a state or going to a TSDF in a state that has not yet adopted Subpart P) is that the healthcare facility/vendor check with such states regarding whether they require all applicable waste code to be on the manifest.

A copy of the Guidance can be downloaded here.