USDA, FDA and EPA Called Before Congress to Report on Implementation of Hemp and CBD Regulations

Jul 25, 2019

By: Jessica Wasserman, Partner

Today the Senate Agriculture Committee held the first full Committee hearing on implementation of the hemp provisions of the 2018 Farm Bill. The Senate called the hearing in order to hear from the agencies working on implementation and to give Congress a chance to make clear that it expects the agencies to move forward expeditiously to implement the new law on hemp.

Senate Leader McConnell, the Republican Senate Majority Leader, kicked off the hearing stating that he believes that the implementation process is “in the red zone” with several critical areas to be worked out. The key areas for additional implementation that McConnell called out were: crop insurance; FDA regulatory clarity; credit card clarification; and EPA pesticide approvals. McConnell stated that we are: “Close to the end zone and I hope that hemp will be a really big deal in a lot of states.”

Key Takeaways:

Unfortunately, on the key matter of FDA regulatory clarity there was no new information. FDA repeated that there is not enough data to move forward and that the agency would give a status report in the fall.
USDA announced that whole crop insurance would be available for hemp this season with other crop insurance available for future crop years.
USDA announced that it is working on a national “farmer friendly” standard for 0.3 THC testing.
EPA is moving quickly on approvals for pesticides and MRLs on hemp.

The Panel Included:

The Honorable Greg Ibach
- Under Secretary for Marketing and Regulatory Programs\
- U.S. Department of Agriculture
- Washington, D.C.
- Download Testimony

The Honorable Stephen Alexander Vaden
- General Counsel, U.S. Department of Agriculture

The Honorable Alexandra Dapolito Dunn
- Assistant Administrator, Office of Chemical Safety and Pollution Prevention
- U.S. Environmental Protection Agency
- Download Testimony

- Principal Deputy Commissioner of Food and Drugs, Office of the Commissioner
- U.S. Food & Drug Administration
- Download Testimony

Highlights from Testimony

The key role of EPA is to approve new pesticides so that cutting edge pesticides are available to growers. EPA must approve pesticides and labeling, and since May 2019 EPA has received 10 requests to include hemp on labels. The requests have been for biological and microbial pesticides, which can be approved quickly. In addition for food and animal feed, EPA sets MRL limits. The biological and microbial are exempt from MRL tolerances so EPA can approve quickly.

FDA painted a picture of an unruly marketplace, including “an explosion of gummies and chocolates”, and an agency stymied by not enough data. Abernethy emphasized that adding CBD to food, or marketing CBD as a supplement is prohibited. Drugs should not be added to food.

FDA stated that “the data we do have is that CBD can harm the liver, cause exhaustion and affect appetite” and that there is risk when no physician is supervising and when used for months and years. In addition, there are risks to pregnant women, children, and when taken with another drug. Studies just have not been done yet.

FDA is:

Conducting a gap analysis and work plan
Reviewing all information on the record
Reviewing hearing public docket with over 4,000 submissions
Providing update by early fall

USDA stated that it is setting up a testing program that is farmer friendly and does not trap farmers on 0.3 THC unnecessarily.

For more information contact [email protected] or 202-669-9449.

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USDA, FDA and EPA Called Before Congress to Report on Implementation of Hemp and CBD Regulations

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