MassDEP declines full adoption of EPA 'Farmer Rule' (Subpart P) now, invites written comment

MassDEP told stakeholders it is not proposing to adopt the remainder of EPA’s Subpart P (known as the ‘Farmer Rule’ for hazardous pharmaceuticals) in the current regulations package and is seeking stakeholder input before making a final decision.

A MassDEP staff member explained: “As many of you know, we have adopted the exclusion for certain nicotine, smoking cessation products. However, at this point, we are not proposing to adopt the rest of Subpart P for reasons that I'll get into later on.” The staff member said the agency is evaluating whether Subpart P would meaningfully reduce hazardous pharmaceuticals reaching unregulated facilities, and expressed concern that the rule is detailed and could be difficult for MassDEP’s multimedia inspectors to implement and enforce alongside air and water inspections.

During the call, Nikki Radagon of CVS Health asked whether MassDEP would accept written comments after the call; she said consistency across states is “extremely helpful to ensure compliance” for companies with facilities in multiple states. Radagon asked, “Are you also accepting, like, a written comment after this call that could be submitted to you?” The agency replied that it will accept written comments (the staff member said comments could be emailed and that the agency would accept comments through the end of the month) but noted the session was not a formal public hearing under the Massachusetts Administrative Procedure Act (Chapter 30A). The staff member said the agency would consider experiences from other states that have implemented Subpart P before deciding whether to adopt it now or in a later package.

MassDEP also pointed stakeholders to a “blueprint for managing pharmaceutical waste” and other EPA resources and checklists to help stakeholders review the rule’s details. The staff member said the agency expects to finalize the list of regulations, prepare drafts for public comment and hold the required public hearings later in the rulemaking timeline, but cautioned that rulemaking and federal authorization can extend the timeline and that it may take a year or two to reach finalization.

Ending: MassDEP asked stakeholders to submit written comments (the agency said comments will be accepted through the end of the month) and offered to discuss specific state‑level language suggestions for any proposed regulatory change to Subpart P.