First, the requirements for small, direct-marketing farms: FARFA helped lead the fight in Congress to exempt small-scale, direct-marketing producers from the burdensome new requirements under FSMA. Those “qualified exempt” farms have to keep certain records, but do not have to comply with the broad, expensive requirements of the Produce Safety Rule that cover their water sources, employee training, buildings, equipment, harvest practices, and more.
FDA’s own estimate when it promulgated the Produce Safety Rule was that it would cost an average of almost $25,000 the first year for a small farm to comply with the substantive regulations, with many of those costs continuing each year–so this exemption is vital for our producers!
The federal law requires only that these farms keep internal records, so that they can produce them upon request if the agency has reason to believe that the farm isn’t exempt. But TDA’s proposed rule requires every qualified exempt farm to affirmatively submit paperwork to the agency every other year.
The agency claims this is necessary so that it can determine if the farms really are exempt. But with hundreds–as many as 1,000 or more–of qualified exempt farms in Texas, the idea that the agency staff will have time to analyze their paperwork is absurd. The agency has only six inspectors for the entire state! The real issue is registering the farms, although the agency has avoided that term.
And it could all too easily lead to farms being randomly targeted based on paperwork issues. Notably, while requiring farmers to submit documentation to the agency, the proposed rule gives no specifications as to what that documentation will need to include.
To make it worse, the agency’s proposed rule states that a farm that fails to file its biennial paperwork will automatically face an inspection and the agency will presume “that the farm is subject to all requirements of the Produce Safety Rule.”
In other words, a small farm that is exempt from FSMA, but that failed to file paperwork with the TDA for whatever reason, would face an inspection and enforcement action in which the burden of proof would lie with the farm rather than the agency. Given the extensive burdensome requirements of the Produce Safety Rule, it is all but guaranteed that the small farm would not pass the inspection and would face multiple citations and fines.
We raised this issue with TDA’s earlier proposed rule. Rather than address the real concern, TDA has focused its attention on whether the estimated annual costs are closer to $25,000 (as FDA’s 2015 document provided) or $21,000 (based on a more recent estimate) … when either number is enough to put a small farm out of business!
Second, the creation of new, subjective standards: The federal Produce Safety Rule contains multiple provisions that leave great discretion to the inspecting agency, such as whether a farmer takes “reasonable steps” to exclude wildlife from their fields. This is bad enough, but TDA’s proposed rule makes it worse by adding yet another highly subjective regulatory standard: “egregious conditions.” Under the proposed rule, TDA would be able to enter any produce farm at any time of the day or night, and to stop sales from that farm for an unspecified period of time, if there are “egregious conditions.”
This term is not found in FSMA or in the FDA’s implementing regulations, and has a very broad, vague definition. We spoke with TDA about this at length after its first proposal, suggesting that at the least the agency could provide a list of examples to give concrete meaning to the term. But the agency chose not to do so, instead simply repeating its original, vague and potentially arbitrary definition in this new proposed rule.
The agency did make two good changes from its original proposed rule. The new proposed rule would no longer require the tiniest farms (those under $25,000 in annual sales) to register with the agency. And the proposed penalties are far more reasonable. But the agency did nothing to address the two core issues discussed above. You can see a chart comparing the December 2018 and June 2019 proposed rules here.
TAKE ACTION #1
- Remove the provisions requiring qualified exempt farms to submit their paperwork every other year. The provision that allows the agency to inspect a qualified exempt farm during normal business hours to determine whether it meets the requirements for the exemption is sufficient.
- Either remove the “egregious conditions” provisions or provide a definition that includes clear, non-subjective, concrete guidance as to what constitutes an egregious condition.
TAKE ACTION #2
TAKE ACTION #3