Over the last 10 years, a significant number of outbreaks of contaminated foods, including E. coli and Listeria, have caused severe adverse health events – even death – for many American consumers. In November 2015, the Food and Drug Administration (FDA), pursuant to its authority under the Food Safety and Modernization Act (FSMA), published a final Rule titled “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” (the Produce Safety Rule). Intending to address the safety of produce entering the human food chain, this new Rule establishes “science-based minimum standards for the safe growing, harvesting, packing and holding of produce.”
The Rule sets out new procedures, processes and practices to minimize the risk of severe adverse health consequences stemming from the consumption of tainted raw fruits and vegetables and is intended to cause the agricultural food industry to adopt a more proactive preventive approach to produce safety. The goal is to ensure that agricultural products that make it to the American marketplace have been subjected to certain controls designed to specifically address the most common food safety threats.
Scope of Produce Safety Rule
The Produce Safety Rule applies to the growing, harvesting, packaging and holding of Raw Agricultural Commodities (RACs) grown for human consumption, regardless of whether they are obtained from domestic or foreign sources. RACs are any food products in their raw state, including fruits and vegetables, which are washed, colored or otherwise treated in their natural form. (21 C.F.R. § 321(r).) The Produce Safety Rule, however, does not apply to all RACs. The following RACs are exempt, because the FDA has found that they pose a low risk to public health:
- Produce that is rarely consumed raw. The new Rule provides a significant list of qualifying products, including asparagus, many varieties of beans, beets, eggplants, horseradish, potatoes and water chestnuts;
- Produce that is used for personal use on a farm;
- Produce that is not a RAC; and
- Produce that receives commercial processing that adequately reduces the presence of potentially harmful microorganisms, so long as the process is appropriately documented. These include, among others, RACs that are turned into oils, wine, spirits, beer, and sugar.
The FDA has also provided an exemption for produce from small farms that meet certain requirements including:
- Farms that have sold less than $25,000 in produce in the last three years;
- Farms that have both:
- Sales averaging less than $500,000 per year during the previous three years; and
- Sold a majority of their products to qualified end users (direct sales to final consumers or nearby restaurants)
Major Sections of Produce Safety Rule
Those farms and RACs that are covered by the new Rule are now required to implement a series of controls, processes and procedures that historically have been optional. The new Produce Safety Rule is expansive and contains many exceptions, as well as some narrowly written requirements, the major components of which are as follows.
Worker training and hygiene
Farms are now required to establish worker training, hygiene practices and other qualifications and requirements for all personnel (and their supervisors) who come into contact with covered produce products or food-contact surfaces. The Produce Safety Rule also requires new record-keeping practices to document all training programs, as well as any corrective actions taken if produce becomes tainted/adulterated.
Agricultural Water purity and safety
Agricultural Water, as defined under the Produce Safety Rule, is water that is intended to, or is likely to, contact the harvestable (or harvested) portion of produce or food contact surfaces. All Agricultural Water is required to be safe and of an adequate sanitary quality for its intended use. To comply, the grower or processor must meet farm-specific requirements for inspection, maintenance and other actions related to the use of agricultural water, water sources, and distribution systems used to grow, harvest, pack and hold covered produce products.
Biological Soil Amendment
Biological Soil Amendments (BSAs) are soil additives (amendments) that consist, in whole or in part, of materials derived from animal origin, such as manure, non-fecal animal byproducts (such as animal carcasses), or table waste. The Produce Safety Rule establishes specific requirements for determining whether BSAs need to be treated or untreated and establishes requirements for its handling, moving, storing and application. Included in the Produce Safety Rule is a prohibition on the use of human waste on covered produce (with narrow exceptions for allowed uses under EPA regulations). Furthermore, the Rule establishes science-based requirements for the treatment of BSAs with scientifically valid and verified controlled biological, physical and/or chemical processes that achieve compliance with established microbial standards. There are also requirements for records-keeping and documentation, not just for the use of the use of BSAs, but other related matters, such as supplier verification.
Domesticated and wild animals
The Produce Safety Rule also addresses the presence of wild and domesticated animals around growing produce. Farmers are expected to evaluate whether there is a “reasonable probability” that grazing animals, working animals, or intrusion by wild animals could contaminate produce covered by this Rule. If farmers find that such produce is reasonably likely to have been contaminated with a known or reasonably foreseeable hazard, they are prohibited from harvesting any such produce.
Equipment, tools and buildings
With the Produce Safety Rule’s emphasis on protecting the safety and integrity of produce, farms are now required to better control for and monitor the cleanliness and safety of tools, equipment and buildings used in the growing, harvesting and processing of produce. Each farm must establish cleanliness and safety requirements for tools, building facilities and other equipment that come into contact with produce covered by the Rule. These requirements must include, but are not limited to, instruments, controls, equipment used in transportation and shipping, domesticated animals, pest controls, hand-washing facilities, toilet facilities, sewage, trash, plumbing and animal waste.
The FDA has identified sprouts as a RAC that is particularly susceptible to contamination. Farmers must monitor sprouts for safety and integrity at all growing, harvesting and processing stages, except for those soil or substrate-grown sprouts harvested without their roots. Farmers have an affirmative duty to take measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into or onto seeds or beans that will be used to grow sprouts. Farmers must establish procedures for physical inspection of seeds and beans, as well as the packaging used to ship them, for signs of contamination. Procedures also need to be instituted in either treating the seeds or beans, or obtaining supplier certification that the seeds or beans have been treated to reduce harmful microorganisms. These processes will need to be documented.
Farmers who discover contamination because of testing results are not required to stop using the seeds if they can be, and are, treated with a process that is reasonably certain to achieve destruction or elimination of the most resistant microorganisms of public health significance. Finally, all steps must be documented and recorded, including any corrective actions in a case where certain pathogens are detected.
Taken together, the Produce Safety Rule represents a significant increase in the regulatory burden for farmers growing, harvesting or processing produce covered by the Produce Safety Rule. The Rule has staggered compliance deadlines that depend on a farming operation’s size.
If you are a member of the industry with any questions regarding this Rule or any of the recent rulemakings by the FDA under FSMA, Thompson Coburn has a team of attorneys with decades of experience with FDA compliance, the implementation of FDA rules and food safety plans and assisting companies and clients in the food and food agriculture industry. Please contact life sciences partner Diane Romza-Kutz.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.