Thursday, January 27, 2022

The “Almost Top 10” of 2021 (Part 5)


I continue my journey through the big developments of 2021 that didn’t make my “Top 10” list.  In Part 5 today, I look at two more developments – FDA rule changes to water qualify testing for ag water, and a Missouri food labeling law that was upheld as constitutional by a federal appellate court.

More not quite top 10 developments from 2021 – it’s the topic of today’s post.

FDA Proposes Tightening of Water Quality Testing

FDA Notice of Proposed Rulemaking, 86 FR 69120 (Dec. 6, 2021)

On December 6, 2021, the Food and Drug Administration (FDA) published proposed amendments to the agricultural water regulations contained in the Produce Safety Rule (PSR).  The ag water regulations cover groundwater and numerous surface water sources including ponds, rivers, creeks, as wells as municipal and other public water supplies.   According to the FDA, the proposed rule is designed to make pre-harvest testing of water more practical and less complex while simultaneously protecting public health.  FDA says the proposed rule is designed to be flexible to more easily adapt to future developments in water quality science.  According to the FDA, the new rule would replace the current PSR with systems-based preharvest ag water assessments designed to identify conditions that are reasonably likely to "introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces, and to determine whether corrective or mitigation measures are needed to minimize the risks associated with preharvest agricultural water."

The PSR is a rule that is part of the implementation of the Food Safety Modernization Act (FSMA), enacted in 2011 as an amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA). The FSMA amended the FFDCA to require the FDA to establish minimum standards for the production and harvesting of certain fruits and vegetables that are raw ag commodities for which the Secretary determines that the minimum standards will minimize the risk of serious adverse health consequences or death. Accordingly, the FDA published a the proposed PSR in 2015 to apply to “covered produce” that are regularly consumed raw. Farmers of covered produce must ensure that there is no detectable E. coli in 100 milliliters of water used to irrigate the covered produce. “Very small producers” (those selling less than $250,000 of covered produce annually over the last three years) were to be in compliance by January 26, 2022. “Small producers (those selling annually between $250,000 and $500,000 of covered produce) had to comply by January 26, 2021. All other producers had to be in compliance by January 25, 2020.  Based on producer feedback, the FDA issued a proposed rule in 2017 extending the compliance dates to January 26, 2024; January 26, 2023, and January 26, 2022, respectively.

The December 6, 2021, proposed rule would amend the ag water requirements for farmers growing covered produce other than sprouts, and would require growers to annually prepare a pre-harvest written ag water assessment and notification anytime a significant change occurs to the grower’s ag water system that introduces a contamination risk. A grower must identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce. The proposal specifies five factors for consideration when composing an ag water assessment – 1) whether the water is ground water or surface water and whether the water is in an open or closed system; 2) the type of irrigation system used; 3) the characteristics of the crop(s) at issue; 4) environmental conditions (e.g., heavy rain or extreme weather events); and 5) the results of any testing the farmer conducted.

Three exemptions from conducting an ag water assessment are provided – 1) if requirements are met for water used on sprouts and in harvesting, packing and holding; 2) if the only water used is from a public water system or public water supply; and 3) if the water used on covered produce is treated according to requirements contained in the proposed rule. The FDA also stated that it anticipates publishing another proposed rule extending the compliance dates. The comment period on the proposed rule runs until April 5, 2022. If finalized, the new rule would replace the pre-harvest microbial quality criteria and testing requirements of the PSR. 

Food Labeling Law Upheld

Turtle Islands Foods, SPC v. Thompson, 992 F.3d 694 (8th Cir. 2021)

In recent years, food labeling issues have been in the courts.  It is an important issue to many ag producers because of the connection to marketing of ag products and the ability to properly market those products to consumers and ensure that consumers have full knowledge of the content of what they are purchasing.  In 2021, a Missouri food labeling law was challenged on constitutional grounds and upheld.

Missouri law (Mo. Rev. Stat. Sec. 265.282(7)) criminalizes the misrepresentations of a product as meat that is not derived from the harvested production of livestock or poultry.  Violations are a Class A misdemeanor that are penalized by up to a year in prison plus a fine not to exceed $1,000. The law is specifically directed at Missouri businesses that market their products that are plant-based or cell-cultured as “meat-based” and sell them as “alternative” protein sources (which implies that the products contain real meat).  The plaintiff, a maker of a vegetarian turkey substitute (Tofurkey), challenged the law as an unconstitutional violation of free speech, due process and the Dormant Commerce Clause and sought a preliminary injunction preventing the state from enforcing the law. The state submitted evidence showing how the plaintiff could comply with the law by labeling their products as “plant-based,” “veggie,” “lab grown,” or something similar.

The trial court denied the plaintiff’s request for an injunction on the basis that the law only barred a company from misleading consumers into believing that a product is meat from livestock when it is not. The trial court also determined that the plaintiff had failed to prove an irreparable injury by risk of prosecution because its packaging already contained the necessary disclaimers.

On further review, the appellate court affirmed. The appellate court noted that the plaintiff admitted that its products were labeled in such a way to clearly indicate that the products did not contain meat from slaughtered animals and denoted that they were plant-based, vegan or vegetarian. The appellate court noted that, on remand at the trial court, facts could be discovered that could possibly lead to a different result on appeal.

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