What is this “FSMA” thing that so many of the produce growers interviewed for our “The Queen’s Garden: Oral Histories of the Piedmont Foodshed” project keep talking about?

 

Well, it’s a bit complicated. It all started with a problem. A pretty big one, in fact.

 

What Happened?

 

In 2011, the Center for Disease Control and Prevention estimated that foodborne pathogens caused 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year in the United States. Some 38.4 million of those episodes were blamed on “unknown agents.” 

 

The problem was due in large part to how the food supply chain was regulated. Until the late 2000s, food safety regulations focused primarily on the back end of the food supply chain: food processing, handling, and manufacturing. There was relatively little regulatory oversight of food sources (like farms), and that was typically limited to localized regulations that varied by state and municipality. In 2009, faced with growing nationwide concerns over foodborne illness outbreaks and the potential for bioterrorism, the federal government began looking into the expansion of regulatory oversight to include the entire food supply chain. The result? On December 21, 2010, Congress approved the FDA Food Safety Modernization Act (“FSMA” or the “Act”), which President Obama signed into law on January 4, 2011. 

 

How Does the FSMA Work?

 

The FSMA is the first major overhaul of U.S. food safety practices since 1938. Its primary goal is to protect public health with a national food safety and security system, by shifting the enforcement policies of the U.S. Food and Drug Administration (“FDA”) from a reactive mode to a more proactive strategy. The Act emphasizes prevention, detection, and response (including mandatory recalls and product tracing requirements) in dealing with food safety issues associated with the growing, packing, processing, shipping, and importing food items in and into the United States. The FDA decided to implement the FSMA with seven primary rules centered on:

 

• Produce Safety

• Preventive Controls for Human Food

• Preventive Controls for Animal Food

• Intentional Adulteration

• Foreign Supplier Verification Program

• Sanitary Transportation, and

• Accredited Third-Party Certification.

 

The Act covers the entire food supply chain for both humans and animals, from crop cultivation to food processing and transportation. It is concerned solely with the contamination of food by microbial pathogens (such as E. coli, listeria, norovirus, and salmonella). Risks that may be associated with pesticide use, antibiotic resistance, or genetically engineered crops are not covered by the FSMA.

 

How Does the FSMA Impact Fruits and Vegetables?

 

Produce growers are most directly impacted by the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (also known as the Produce Safety Rule), which was finalized in 2015. Because of the scope of implementing such a comprehensive national regulation structure, including the need to educate a variety of produce growers across the country, compliance requirements for the Produce Safety Rule have been rolled out in stages, starting in 2017 and continuing through 2020, based on types of crops and size of farming operations. Full implementation of the Rule is expected by 2022.

 

As suggested by its formal name, the Produce Safety Rule applies to farms engaged in the growth, harvesting, packing, and storage of produce intended for humans. The Rule sets a series of minimum “science-based” standards impacting all aspects of the agricultural process: water quality, biological soil amendments (namely, compost, manure, and other organic materials), protection of sprouts against contamination, livestock and other grazing or working animals, worker training and health/hygiene, and anti-contamination measures to protect farm equipment, tools, and buildings. The National Sustainable Agriculture Coalition has provided a helpful online guide summarizing these various standards.

 

Are All Farmers and Produce Subject to the Produce Safety Rule?

 

Not exactly. There are several exemptions to the Product Safety Rule’s required standards, including:

 

• The Produce Safety Rule focuses on foods that are usually consumed raw. Most fruits, for example, are subject to the Rule. Crops that are rarely consumed raw (like potatoes or pumpkins) are exempt, as are food grains like rice and oats. The regulations provide illustrative lists of exempt and nonexempt produce.

 

• Only food intended for sale to the general public within the United States is covered by the Produce Safety Rule. Produce raised for personal consumption is exempt. Produce sent to a commercial food processor for further processing is also exempt.

 

• The Produce Safety Rule applies to farms whose average annual gross revenue from produce sales over the preceding three-year period exceeds $25,000. Farms with annual sales consistently under the $25,000 threshold are exempt.

 

There is also a qualified exemption that imposes less stringent standards on farms that satisfy two specific requirements:

 

    1.    Annual food sales averaging less than $500,000 during the previous three years (note: not just produce,              but all food items; think jams, pies, and other baked goods or cooked items that a farming operation may

          offer for sale); and

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    2.   More food sales to “qualified end-users” than to all other customers combined for that same three-year

           period.

 

A “qualified end-user” is either:

 

• the consumer of the food, or

 

• a restaurant or retail food establishment located in the same state as the farm or within 275 miles of the farm.

 

So Exempt Produce Farmers Don’t Have to Worry About the FSMA, Right?

 

There’s the catch. It is up to the produce grower to prove on an ongoing basis that he or she qualifies for any exemption under the Produce Safety Rule.  That means all produce growers who may potentially be covered by the FSMA now have the added responsibility of completing and maintaining specific FDA-mandated records for at least three years, and in some instances longer. Produce growers are also subject to on-farm inspections, because the FSMA gives the FDA the authority to inspect farming operations and their paperwork to ensure compliance and continued eligibility (if applicable) for a Produce Safety Rule exemption.

 

Increased regulatory enforcement obligations under the FSMA have strained the already-limited resources of the FDA.  As a result, the FDA has partnered with state Departments of Agriculture (who previously dealt directly with most farming operations), via the National Association of State Departments of Agriculture, to implement the Produce Safety Rule.

 

What About the USDA and GAP?

 

Like we said, this is a bit complicated. GAP is completely separate and independent from the FSMA.

 

Many of the produce growers interviewed for this project have already qualified for Good Agricultural Practices (“GAP”) certification from the U.S. Department of Agriculture (“USDA”). GAP, which is now combined with the USDA’s Good Handling Practices program into the Harmonized Good Agricultural Practices (or “H-GAP”) program, is a voluntary independent audit program to help produce suppliers grow, pack, handle and store fruits and vegetables in a manner as safe and as consistent with best agricultural practices as possible to limit food safety issues.

 

Sounds familiar, right? The H-GAP program and the FSDA are similar in that they both are designed to promote food safety and security. However, the voluntary H-GAP audit and the mandatory FSDA inspection are not the same thing:

 

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           Source:  United States Department of Agriculture, Agricultural Marketing Services, “Frequently Asked Questions” (June 5, 2018).

 

That said, in June 2018, the FDA did formally recognize the alignment of the USDA’s H-GAP program with the Produce Safety Rule. However, that announcement does not relieve farmers of the mandatory farm inspections and other requirements of the Product Safety Rule or the FSMA. According to the FDA’s announcement, a produce grower who passes a USDA H-GAP audit increases his or her likelihood of passing a FSMA inspection. In short, “alignment” is little more than an attempt to ease the FDA’s enforcement activities and perhaps produce growers’ burden of additional Rule compliance inspections (since they already face multiple market access audits by produce buyers).

 

How Does the FSMA Impact Animals?

 

Farmers who raise livestock (in particular, livestock for consumption and food production) or use work animals are also impacted by the FSMA’s “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (or Animal Food Rule). The Animal Food Rule was finalized in 2015 and rolled out for staged compliance between 2016 and 2019. It applies to businesses that manufacture, process, pack, or hold food for animal consumption within the United States, including feed mills, pet and animal food processors and manufacturers, and holding facilities. The Animal Food Rule marks the first time that manufacturing standards comparable to the manufacturing practices standards for human food have been adopted for animal food.

 

Certain aspects of the Animal Food Rule remain to be finalized, but the minimum compliance standards resemble the minimum standards of the Produce Safety Rule in many respects. In addition to mandatory “current good manufacturing practices” and hazard analyses, businesses covered by the Animal Food Rule are required to satisfy standards for worker health/hygiene, sanitation, safe and adequate water supply, and anti-contamination measures focused on manufacturing plants, food storage facilities, fixtures, equipment, and utensils.

 

While more complicated in some respects than the Produce Safety Rule, exemptions are available under the Animal Food Rule, including exemptions for:

 

• Home-based businesses that process and manufacture feed within a personal residence;

 

• Retailers that sell animal feed or pet food directly to consumers;

 

• Certain “mixed type” farms that raise crops or animals where animal feed processing and manufacturing takes place, if all of the animals that eat the feed are at the same location and under common ownership or management. This exemption gets complicated, as it also takes into consideration the farm’s total sales and number of employees, as well as any unique risks associated with the particular animal feed;

 

• Facilities whose combined inventory value and average annual feed sales over the last three years total less than $2,500,000; and

 

• Facilities that only store raw agricultural commodities for use as animal food.

 

As with the Produce Safety Rule, the FDA has partnered with the National Association of State Departments of Agriculture and many of its member state Departments of Agriculture to implement the Animal Food Rule.

 

So What’s the Big Deal with the FSMA?

 

According to the FDA, “[T]his is all about keeping food safe for consumption. . . . The bottom line is that consumers can have confidence that modern preventive practices will soon be in place, no matter where in the world food is produced.”

 

That is certainly a laudable goal. But at what cost?

 

In November 2010, just before the start of congressional debates on the bill that would ultimately become the FSMA, Grist magazine (www.grist.org), a self-described “beacon in the smog — an independent, irreverent news outlet and network of innovators working toward a planet that doesn’t burn and a future that doesn’t suck,” posed the question “Will the Food Safety Modernization Act harm small farms or producers?” to a panel of consumer advocates and small farm supporters. The resulting article – insightful, animated, impassioned, and often heated – offers a range of views describing the potential benefits and problems of a national food safety system. Two of the comments are of particular interest in their almost prophetic description of the potential impact of the average farmer:

 

“[T]he history of regulation has not always been kind to small players. When I was a kid in the ’70s, I remember a nation dotted with independent gas stations that doubled as mechanic shops. At a certain point, much-needed regulations came into effect regarding the way gas stations protected surrounding groundwater from petrochemical contamination. These regulations carried heavy costs — and as I understand it, drove thousands of small players out of business. Today, gas stations are controlled almost exclusively by the few remaining major oil companies. If much-needed reforms in food safety regulations are poised to do the same thing, then I say, To hell with them.”

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          - Tom Philpott, Grist senior food writer

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“I can tell you, both from personal experience and by virtue of working for thousands of farmers, that the profit margins are so slim, and that producers are so time-pressured during the season, that adding any level of additional record keeping, testing, or regulatory hoops to jump through will make it difficult for many families who are struggling to continue. I can guarantee you these folks are not getting rich and their only desire, in most cases, is to make a fair wage.”

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          - Mark Kastel, co-founder of The Cornucopia Institute

 

Fast forward eight years.

 

In August 2018, the Economic Research Service of the USDA issued a report entitled “Estimated Costs for Fruit and Vegetable Producers to Comply With the Food Safety Modernization Act’s Produce Rule.” The 28-page report – analyzing estimated costs of compliance with the Produce Safety Rule by state, farm size, and commodity – determined that the smallest farms would suffer the heaviest financial burden of compliance, in large part due to costs associated with required recordkeeping, water and soil testing, and employee training (the very added difficulties for farmers that concerned Mark Kastel back in 2010). According to the report, “small” farms (that is, farms with annual sales between $250,000 and $500,000) can expect annual cost increases equal to 6.0% of produce sales, while “very small” farms (with annual sales between $25,000 and $250,000) will have estimated annual cost increases of 6.8% of annual produce sales. In real numbers, those estimates mean an average annual compliance cost of $5,560 for very small farms and $21,136 for small farms.

 

The lead author of that USDA report, Dr. John Bovay of the University of Connecticut, has offered a more blunt assessment of the FSMA, which he described to the Applied Economic Perspectives and Policy journal as “more [of] a band aid than a cure-all.” Dr. Bovay’s skepticism as to the likely effectiveness of the FSMA is striking: “FSMA will reduce the number of food-borne illness cases by some unknown amount. Even if FSMA is effective, because it is similar to many private and state rules and regulations already in place, I don’t have a lot of confidence that this is going to drastically diminish the number of illnesses.” And the cost of this nebulous benefit? In another interview, Dr. Bovay raised questions in that regard as well: “Our food safety system is quite good in the U.S. and the risks are quite low. It’s not clear [the FSMA rules] will lead to benefits that exceed costs.” What about those “Big Ag” large-scale agricultural operations? Probably not. Because large-scale agricultural operations have long been required by their similarly large customers to satisfy comparable food safety measures, Dr. Bovay explains, “It’s going to accentuate the advantage the big guys have, because the big guys are already complying.” That sounds a lot like the gas station scenario described in late 2010 by Grist writer Tom Philpott.

 

Somewhere, there is a disconnect. Food safety is undoubtedly important. On the other hand, a farmer with annual produce sales of less than $25,000 is hardly profitable, such that any added FSMA annual compliance costs would more likely hurt than help that farmer’s ability to sustain operations. In that scenario, the FSMA compliance exemption certainly seems appropriate. But will that farmer be pressured into compliance anyway, at the risk of losing customers (particularly any retail distributors) who would prefer produce deemed “safe” by FDA standards? What about the farmer with $30,000 in annual produce sales? Is she any more financially capable of absorbing thousands of dollars of compliance costs simply because her sales exceeded the annual $25,000 threshold? Do those added annual costs increase her financial viability of her farm or appreciably increase the safety of her crops?

 

The disconnect goes deeper, according to the National Sustainable Agriculture Coalition. With small and very small farms potentially suffering 6.0% to 6.8% annual FSMA compliance cost increases, the annual profits for farms with less than $250,000 in annual sales would be cut in half, based on 2011 USDA data showing that farmers’ national average net farm income was only 10% of total sales. How sustainable is that? Not very, according to the Coalition, pointing to the FDA’s own expectations that compliance costs with raise entry costs for new farmers and food-related businesses and that farmers will likely have to supplement income with off-farm employment: “Though they do not come right out and say so directly, the obvious implication is that FDA believes its new rules will concentrate farming into fewer and fewer hands.” Again, Tom Philpott’s gas station scenario.

 

And the consumer? The National Sustainable Agriculture Coalition points to an interesting conflict between two governmental estimates: the FDA’s estimates that consumers would willingly pay between $1,507 and $6,189 to avoid foodborne illness, and the Bureau of Labor Statistics’ surveys showing that the average U.S. household purchases only about $715 of produce each year. Why would a family buying less than $1,000 of produce per year voluntarily pay thousands of additional dollars to ensure the safety of that produce? It would be more cost effective to simply stop buying produce. The alternative would be processed fruits and vegetables. The sales volumes a food processing company could generate from large-scale grocery retailers would enable the processor to spread its FSMA compliance costs across its entire product offerings (thereby minimizing any price increases needed to recoup those costs) and to leverage its produce suppliers into FSMA compliance. Either way, are consumers and farmers better served?

 

Without a doubt, food safety requires a delicate balance between reasonable, tangible safety benefits and realistic, cost-effective compliance requirements. Increased safety necessitates increased compliance costs, both of which may adversely impact the continued operations of smaller local farms, the availability of certain types of produce in local communities, and the cost of fresh fruits and vegetables. Can federal regulations generate a reliable food supply that is safe, affordable, and provided by a thriving farming community viable from both a conservation and business standpoint? Perhaps, but it remains to be seen whether and when the FDA can achieve that necessary balance. Much remains to be determined and implemented in the long and often convoluted process that is the FDA Food Safety Modernization Act of 2011.

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