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can now proceed, without reinforcing the FDA’s overreaching claim that covid-19-public-health-emergency-regarding-
live animals are food. qualified-exemption-standards. After the Covid
emergency ends, FDA will issue additional
FOOD SAFETY MODERNIZATION ACT UPDATE: guidance to establish how to calculate average
FLEXIBILITY FOR EXEMPT PRODUCE FARMERS AND TEXAS sales to qualified end users under the second
TROUBLES part of the test, since the sales during the emer-
And speaking of the Tester exemption, in late May the FDA an- gency will affect the calculations for the next
nounced that during the Covid-19 public health emergency, it will provide three years. Qualified exempt farms must keep
flexibility on the criteria for farms to be “qualified exempt” under the specific records, as well as display their name
Produce Safety Rule. and business address on the packaging or at the
Under the Tester Amendment to the FSMA, produce farms are “quali- point of sale.
fied exempt” and do not have to meet many of the expensive, burdensome In other FSMA news: The Farm and Ranch
requirements of the Produce Safety Rule if: Freedom’s lawsuit against the Texas Depart-
ment of Agriculture (TDA) continues, and the
1. The farm’s food sales averaged less than five hundred thousand dol- agency’s responses to initial discovery requests
lars (as adjusted for inflation since 2011) per year during the previous reflect that it is doubling down on its overreach
three years, and and unconstitutional claims of power.
2. The majority of the farm’s sales, in dollar amounts, went to “quali- There is no dispute that the Texas legisla-
fied end users.” A qualified end user is either (a) the consumer of the ture gave TDA the authority to implement the
food, or (b) a restaurant or retailer that is located within the same federal Produce Safety Rule in 2017. But in its
state or the same Indian reservation as the farm, or not more than discovery responses, the TDA claimed that it
two hundred seventy-five miles away, and which directly sells to or has the right not only to enforce the Produce
serves consumers. Safety Rule, but also the authority to enforce
general provisions of the Federal Food, Drug
Both of these elements are based on three-year rolling averages. In & Cosmetic Act. TDA asserts that it can come
other words, to know if a farm has a qualified exemption in 2020, you onto any farm, even those that are “not covered”
would look at the average sales and to whom those sales were made in under the federal Produce Safety Rule, at any
2017, 2018 and 2019. “reasonable” time in order to inspect for what-
The closing of many restaurants and retail food establishments due ever the inspector believes could cause the food
to Covid could mean that a farm that normally would be qualified exempt to be adulterated or misbranded. This is not what
the law provides nor what the Texas Legislature
may not meet the second part of the test. The FDA has issued a guid- intended to do.
ance document that allows farmers to shift their sales to other entities as After another round of discovery, the par-
needed, and still remain qualified exempt. For the duration of the Covid ties will most likely file motions for summary
public health emergency, farms must meet the first prong of the test (the judgment, so a decision in the case is still several
average annual food sales), but not the second in order to maintain their months away.
exemption. The current inflation-adjusted cut-off for average annual gross
sales is about five hundred sixty-two thousand dollars.
FDA’s announcement is posted online at fda.gov/regulatory-
information/search-fda-guidance-documents/temporary-policy-during-

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98 Wise Traditions SUMMER 2020