On Friday, the FDA announced that during the COVID-19 public health emergency, it will provide flexibility on the criteria for farms to be “qualified exempt” under the Produce Safety Rule.
[Meanwhile, the Texas Department of Agriculture continues to overstep its role in administering the federal Produce Safety Rule in Texas, so our lawsuit against them continues. READ MORE.]
Under the Tester Amendment to the Food Safety Modernization Act (FSMA), produce farms are “qualified exempt” and do not have to meet many of the expensive, burdensome requirements of the Produce Safety Rule if:
- The farm’s food sales averaged less than $500,000 (as adjusted for inflation since 2011) per year during the previous three years, and
- The majority of the farm’s sales, in dollar amounts, went to “qualified end users.” A qualified end user is either (a) the consumer of the food, or (b) a restaurant or retailer that is located within the same state or the same Indian reservation as the farm, or not more than 275 miles away, and which directly sells to or serves consumers.
Both of these elements are based on 3-year rolling averages. In other words, to know if a farm has a qualified exemption in 2020, you would look at the average sales and to whom those sales were made in 2017, 2018, and 2019.
The closing of many restaurants and retail food establishments due to COVID could mean that a farm that normally would be qualified exempt may not meet the second part of the test. The FDA has issued a guidance document that allows farmers to shift their sales to other entities as needed, and still remain qualified exempt. For the duration of the COVID public health emergency, farms must meet the first prong of the test (the average annual food sales), but not the second in order to maintain their exemption. The current inflation-adjusted cut-off for average annual gross sales is $561,499.
FDA’s announcement is posted online. After the COVID emergency ends, FDA will issue additional guidance to establish how to calculate average sales to qualified end users under the second part of the test, since the sales during the emergency will impact the calculations for the next three years.
Qualified exempt farms must keep specific records, as well as display their name and business address on the packaging or at the point of sale.
Update: Our Suit Against the Texas Department of Agriculture Continues
Our lawsuit against the Texas Department of Agriculture continues, and the agency’s responses to our initial discovery requests reflect that it is doubling down on its overreach and unconstitutional claims of power.
There is no dispute that the Texas Legislature gave TDA the authority to implement the federal Produce Safety Rule in 2017. But in its discovery responses, the TDA claimed that it has the right not only to enforce the Produce Safety Rule, but also the authority to enforce general provisions of the Federal Food, Drug & Cosmetic Act. TDA asserts that it can come onto any farm, even those that are “not covered” under the federal Produce Safety Rule, at any “reasonable” time in order to inspect for whatever the inspector believes could cause the food to be adulterated or misbranded.
This is NOT what the law provides nor what the Texas Legislature intended to do.
We are now entering another round of discovery – we have sent document requests to the agency, and we are in the process of responding to the agency’s discovery requests to us.
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