Swift Action from the New Administration…
It’s been an exciting week in the Capitol. We’ve seen a time-honored tradition of a new Administration taking the reins of the federal government and with it comes new policy proposals.
We saw those changes take place immediately. On its first day in office, the Biden Administration directed the immediate halt of all Trump Administration policies that were currently under review and open for comment as traditionally occurs when a new administration takes office.
NEW ADMINISTRATION EFFECT ON HEMP REGS FROM USDA AND DEA
In regard to those policies that have been published in the Federal Register, but have yet to take effect, the Biden Administration is asking agencies to consider postponing the rules’ effective date for 60 days. For rules that have been published but have yet to take effect, the Biden Administration is asking federal agencies to consider opening the rule back up for a 30-day public comment period.
This notice would have no particular effect on the rule the Trump Administration published on January 19, 2021 titled Establishment of a U.S. Domestic Hemp Production Program as it is a final rule with an effective date of March 22, 2021, just beyond the 60 days mentioned above. Nevertheless, the new administration can freeze any rule it wants to, and we actually think there’s a decent probability that the new leadership will want to intervene and make further revisions to this rule before it goes into effect (be that by March 22, 2021 or a later date that they may choose to push back to).
With substantial concern still existing in regard to provisions of this rule, NIHC will be working with the new administration to advocate for any area which warrants adjustments within the legal authority that USDA has or with Congress to provide additional legal authority as needed. Should the agency decide to rescind the rule and re-open the public comment period, rest assured that the NIHC will be reaching out to our membership to solicit feedback.
Likewise, the rule issued a few months ago by the Drug Enforcement Agency (DEA) to implement the 2018 Farm Bill should not be affected by this customary regulatory freeze since it was issued as an interim final rule (IFR) with immediate legal effect.
PROSPECTS FOR FDA ACTION OR CONTINUED INACTION
Finally, we get asked a lot about our advocacy for an enforcement discretion policy at FDA. Since the FDA never moved forward to finalize their draft policy, we’re still at the same place at the beginning of the Biden Administration that we were at the end of the Trump Administration: we’re waiting for the FDA to act.
We continue to believe that the inaction of the FDA on this critical issue is unacceptable and a failure of the agency to complete its most basic duty to protect public health. However, this inaction is representative of inherent problems with the agency and does not appear to be something that will change due to new political leadership. Unfortunately, the change in administration is likely to do nothing but add further delays – particularly as the agency waits for the Senate to confirm a full time Commissioner to lead the agency’s policy direction.
NEW AGENCY HEADS AND CABINET YET TO BE NAMED
A new administration always names a host of new agency leads and while the Biden Administration has designated cabinet secretaries, the U.S. Senate has yet to confirm all but one of President Biden’s cabinet. Until that time each agency is led by career civil servants. A list of acting Secretaries currently leading federal agencies can be found here. Kevin Shea, the Associate Administrator at the Animal and Plant Health Inspection Service (APHIS) will be leading the USDA as acting Secretary until the Senate confirms former Obama Administration USDA Secretary Tom Vilsack, who President Biden has renamed to serve in his prior post.
Trump-era FDA Commissioner Stephen Hahn resigned this week and has been replaced by Janet Woodcock who is now leading the FDA in an acting capacity. POLITICO reports that the FDA “is among a second wave of positions that could take months to move through Senate confirmation.” Under consideration for nomination to this post is Woodcock, former Obama Administration FDA official Josh Sharfstein, and current Principal Deputy Commissioner of Food and Drugs, Amy P. Abernethy.
It’s worth noting that in July, Dr. Abernethy participated in an exclusive NIHC led discussion with hemp industry leaders in her capacity as head of FDA’s CBD Working Group to discuss our recommendations for an enforcement discretion policy on CBD.
It’s an exciting time to be in Washington and we’re anxious to continue working on your behalf to solidify the voice of hemp with the new Biden Administration.
