Proposed Rule to Reschedule Cannabis Officially Published in Federal Register

On May 16, 2024, President Joe Biden published a video providing his long-awaited announcement that the Biden administration is actively taking steps to reschedule cannabis under the Controlled Substances Act (CSA). Hours later, the Drug Enforcement Administration (DEA) published its Proposed Rule to Reschedule cannabis from Schedule I to Schedule III. 

This step forward represents a monumental advancement in the drug policy reform movement, as it signifies the U.S. federal government’s official recognition of the cannabis plant’s medical value. The clock starts today; however, rescheduling cannabis will be a lengthy process. Amending the scheduling of a controlled substance through administrative procedures takes place in five parts: (1) review by White House Office of Management and Budget (OMB); (2) publishing the notice of proposed rulemaking in the Federal Register; (3) request and review of public comment; (4) public hearing; and (5) issuance of the Final Rule. Below is a brief overview of the procedures that must be followed by the federal government to initiate a scheduling change.

Initial Review by White House OMB

Prior to the DEA publication of its notice of proposed rulemaking, the White House’s OMB will review the DEA’s proposal. The OMB will assess budget, regulatory impacts, legislative changes, and then sign off on the DEA’s rule. This stage may last up to ninety (90) days.

Publishing the Notice of Proposed Rulemaking

Once the OMB issues an approval, formal rulemaking will commence with the publication of a Notice of Proposed Rulemaking in the Federal Register. Publication in the Federal Register initiates the process outlined by the CSA, involving rulemaking “on the record after opportunity for a hearing” as mandated by the Administrative Procedures Act. On May 16, 2024, the DEA published its notice of proposed rulemaking. Comments must be submitted electronically or postmarked on or before sixty (60) days after publication in the Federal Register.

You can read the DEA’s announcement of proposed rulemaking here.

Engaging in Public Comment

A significant phase ensues with the public comment period. The DEA will accept input from various stakeholders, ranging from ordinary citizens to healthcare providers and major drug manufacturers. The Department of Justice (DOJ) encourages that all comments be submitted through the Federal Rulemaking Portal and to be sure to reference “Docket No. DEA1362” on all correspondence, including any attachments. It is important to note that the electronic Federal Docket Management System will not accept comments after 11:59 PM Eastern Time on the last day of the comment period.

All comments received in response to the docket are considered part of the public record, and feedback received during this stage could prompt adjustments to the proposed rule. The DOJ will make comments available for public inspection online here. If you would like to submit a public comment, please reach out to our Firm. We are happy to assist you with this process.

Public Hearing 

In addition to submitting public comment, stakeholders are also permitted to request a public hearing. All requests for a hearing must be sent to DEA. The decision of whether an in-person hearing will be needed in the rulemaking process will be made by the Administrator of DEA. Upon the Administrator’s determination to grant an in-person hearing, DEA will publish a notice of hearing on the proposed rulemaking in the Federal Register. While the DEA has discretion to grant or deny a request for a public hearing, it is likely that, if there are requests for one, the DEA will grant such requests. 

If the DEA Administrator determines to grant an in-person hearing to address opposition to this rulemaking, the Administrator will then designate an Administrative Law Judge (ALJ) to preside over the hearing. The purpose of the hearing would be to review factual evidence and expert opinion regarding “whether marijuana should be transferred to schedule III of the list of controlled substances.” If, after the hearing, the DEA affirms its proposal to reschedule cannabis to schedule III, the DEA will prepare the scheduling change and likely additional cannabis-specific regulatory controls that would be necessary to comply with relevant international treaty obligations. 

Issuance of the Final Rule

After the public comment and hearing process has been completed, and assuming there is no litigation or other obstacles that delay the aforementioned processes, the DEA will promulgate a final rule. It is important to note that there is often a delayed effective date for these types of regulatory changes, so it is still uncertain as to whether cannabis rescheduling would take effect upon adoption. 

For more information, please reach out to info@feldmanlegaladvisors.com

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