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FSMA Produce Rule: What Produce Farms Need to Know
David Hatch

By: David Hatch on March 20th, 2019

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FSMA Produce Rule: What Produce Farms Need to Know

FSMA

Like many aspects of food safety, the details surrounding compliance with industry regulations are complex. In efforts to protect consumers, the Food Safety Modernization Act (FSMA) has mandated prevention-based protocol for all sectors of the food industry, including produce farms. In fact, the Produce Rule presents its own nuances and requirements for which farms must be especially prepared. To help you grasp the ins and outs of the Final Rule on Produce Safety and develop a stronger understanding of your obligations, we’re providing a breakdown of important information.   

FSMA’s Produce Rule provides the minimum standards for safe production and harvesting of fresh fruits and vegetables for human consumption. It comprises key requirements in the areas of Agricultural Water, Biological Soil Amendments, Sprouts, Domesticated and Wild Animals, Worker Training, Health and Hygiene, Equipment, Tools and Buildings. Following is a summary of the fundamental aspects of this rule. From affected parties and products to essential deadlines, recent changes and expert advice to stay on track, this resource offers valuable guidance on addressing your compliance responsibilities.

 

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Who Needs to Comply?

The FDA claims responsibility for ensuring the safety of all domestic and imported fruits and vegetables. To accomplish this, the agency is focused on identifying and implementing measures that reduce foodborne illness in this important category of food. Because contamination can take place during various aspects of the farm-to-fork process, the Produce Rule addresses the following definitions of applicable farms, activities and types of produce:

  • Covered Farms: Those that annually gross more than $25,000 in sales of produce, averaged across a rolling three-year period, and adjusted for inflation (with 2011 as the baseline year)

  • Covered Activities: Growing, harvesting, packing or holding covered produce on a farm

  • Covered Produce: Any fruit or vegetable, as well as mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts and herbs, that are in their unprocessed state and usually consumed raw. The FDA’s non-exhaustive list of covered produce can be found here.

The Final Rule on Produce Safety does NOT apply to:

  • Produce that is not a raw agricultural commodity (i.e., any food in its raw or natural state)

  • Produce commodities that the FDA has identified as rarely consumed raw, including asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts

  • Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed)

  • Produce that is used for personal or on-farm consumption

  • Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less

A farm can also be exempt if it meets special criteria, and variances may be requested for circumstances that meet the FDA’s specifications in its Final Rule on Produce Safety.

 

What Dates Are Critical to Know?

Though the Produce Safety Rule was first proposed in January of 2013, the final rule was not officially published until November 27, 2015, with an effective date of January 26, 2016. Make sure you are on track with the FDA’s stated compliance dates:

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What Has Changed Since the Effective Date? 

Because agricultural water can be a major conduit of pathogens that contaminate produce, the Final Rule on Produce Safety sets microbial quality standards for agricultural water. These standards, however, have proven to be so complex that understanding, translating and implementing them has become a source of difficulty and contention. As such, the FDA is evaluating options to simplify these standards and plans to extend the compliance dates for the agricultural water provision.

As explained in a recent Food Safety Magazine article, “The current provisions need to be amended, because as currently formulated, they are overly prescriptive, cannot be practically implemented by most farms and provide limited value in protecting public health. A more flexible approach that incorporates new science and technology, such as the use of metagenomics, to better characterize agricultural water source and distribution system microbial quality is the only viable solution going forward. Everyone agrees that agricultural water needs to be of appropriate quality for its intended purpose. However, how that is measured does and will vary based on situation specifics of a particular water source and distribution system. Over time, additional FDA guidance to industry, using data derived from agricultural research, should provide the produce industry with situation-specific, safe-harbor guidance as to how one determines whether the microbial quality for agricultural water in a specific situation is or is not adequate for its intended purpose.”

 

Is There Compliance Support for Produce Farms?

The answer to this question is a resounding “yes.” The responsibility of protecting consumers from contamination falls, in large part, on the shoulders of the farms that grow, harvest, pack and hold produce -- but that doesn’t mean compliance has to be burdensome. The use of automation to streamline compliance efforts is a crucial catalyst of food safety all along the supply chain. A valuable software like CONTROL enables you to keep segmented aspects of your farm’s food safety and compliance approach both organized and efficient.

FSMA was designed to bring food safety efforts into the 21st century. It has prompted businesses throughout the food industry to adopt proactive versus reactive measures and to focus on the early identification and prevention of issues associated with foodborne illness. With the technological advancements now available in the industry, you have the benefit of top solutions at your disposal to meet this challenge head on and fully comply with current regulatory standards.

To get a closer look at the comprehensive food safety solution that supports compliance and helps minimize risk, download your free CONTROL guide.

How Does Food Safety Software Facilitate Compliance and Minimize Risk?

Access your free guide to uncover the answers and learn more.

DOWNLOAD NOW

About David Hatch

Dave Hatch has spent over 30 years solving data management, information security and analytics challenges across multiple industries, including food/beverage, healthcare, publishing, manufacturing and financial services. As Chief Strategy Officer at Corvium, Dave focuses on the emerging digital transformation occurring in the food industry, and its impact on the advancement of food safety programs across the food supply chain.