The choice between eating a salad or a frosted donut may seem obvious in terms of nutrition, but for many of us, this can be a difficult decision. Despite our knowledge of the health benefits of fruits and vegetables, the majority of Americans are still failing to follow the federal dietary guidelines. In fact, a recently published study revealed that only 1 in 10 of American adults consume the recommended amounts of fruits and vegetables (CDC, 2017).

While many consumers struggle with eating healthy, food industry professionals face numerous challenges presented by the Food Safety Modernization Act (FSMA) that require a solid understanding of the new regulations to meet compliance. Since the law took effect, the food industry has witnessed several outbreaks related to fresh and frozen produce. During this time, we have tracked the regulatory activities related to the implementation of the seven core FSMA regulations, including the rule for produce safety.   

In step with the FSMA focus on produce safety, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have published reports, guidance and sampling assignments related to fresh produce and produce safety in recent months. Growers and buyers of fresh produce should be aware of recent trends in produce safety and understand the agricultural water provisions, mandated training and other requirements of the regulation.

Produce Safety Trends

Within the past year, many cases of foodborne illness in the U.S. have been linked to fruits and vegetables, including cantaloupe, papayas, and raspberries. Since January 2017, microbial hazards have triggered several FDA food recalls of agricultural commodities, including: peas, green beans, carrots, blueberries, broccoli, strawberries, spinach, tomatoes and cherries.

It has been estimated that nearly half of all foodborne illnesses between 1998 and 2008 were due to contaminated produce (CDC, 2013). A new study by researchers from the CDC and FDA (Parker et al, 2017) investigated the causes of multistate foodborne disease outbreaks attributed to imported produce in the United States during the years 2006 to 2013. The study aimed to identify the produce types and ports of entry associated with the highest incidence of outbreaks to improve targeted sampling activities.

FDA and Produce Safety

While foodborne illness has been linked to produce for years, the FDA only recently began to address it from a regulatory perspective. The 2015 final rule, Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, established the first federal science-based minimum standards to ensure the safe growing, harvesting, packing and holding of raw agricultural commodities. The key areas addressed by the rule include water quality, biological soil amendments, sprouts, domesticated and wild animals, worker training, health and hygiene. Ultimately, the final rule should prevent biological, chemical and physical hazards in fresh fruit and vegetables.

In September, the FDA issued a small entity compliance guide and proposed an extension of the FSMA compliance dates for produce (other than sprouts) by two years. The agency will retain the staggering of compliance dates based on farm size.

Microbial quality standards for water were emphasized within the FDA’s produce safety rule since fresh produce is often contaminated by pathogens from contaminated agricultural water. The rule established two sets of criteria for agricultural water quality based on the presence of generic E. coli.

Due to industry concerns about the testing requirements, the agency proposed a two-year extension of the requirements. Large produce farms are now expected to comply with the water testing requirements by January 2022.

While the extension was welcomed by the produce industry, consumer advocacy groups are strongly opposed. In November, the Center for Science in the Public Interest (CSPI) and the Center for Food Safety filed comments with the FDA to express concerns about a proposed extension of implementation of the water quality and testing requirements. According to the groups, the delay in microbial testing will contribute to “illnesses and deaths from fresh produce tainted by animal feces.”

The agency is set to begin produce farm inspections by Spring 2019.

Microbial Sampling Targets

An upcoming FDA surveillance sampling program involves testing for microbial contaminants in fresh herbs, such as cilantro, basil and parsley, as well as processed avocado and guacamole. Samples of fresh herbs will be tested for Salmonella and Shiga toxin-producing E. coli (STEC). Processed avocado and guacamole samples will be analyzed for Salmonella and Listeria monocytogenes. According to the assignments, FDA inspectors will collect samples from a diversity of locations, establishment types, seasonality and product varieties. Sampling should reflect current market production, but some establishments or importers may incur multiple sampling visits within one year.

Responding to Industry Concerns

In November, the General Accountability Office (GAO) published a report (GAO-18-85) detailing the FDA’s progress toward implementing the Produce Safety rule and its use of the online FSMA Technical Assistance Network (TAN) for responding to industry concerns about the rule.

Within the past year, the FDA has fielded numerous industry questions related to the agricultural water standards, including concerns about the acceptability of water testing methods. The agency also tackled many questions related to the types of produce covered by the rule and whether a particular operation would be subject to the produce rule or the FSMA rule for preventive controls.

Like the produce industry, the FDA has faced challenges stemming from the produce safety rule. According to the GAO report, the greatest challenges facing the FDA last year included identifying businesses subject to the rule and providing consistent, region-specific information in response to industry questions.

Growing Demand for Produce

Despite our current knowledge of the importance of fruits and vegetables to prevent several significant chronic diseases, the Western Diet is alive and well. However, a recent study by the market research firm, NPD Group suggested the Millennial generation is changing the North American market for fruits and vegetables. According to the study, Millennials are more health-conscious and acquire healthier eating patterns at an earlier age than previous generations.

The consumption of fruits and vegetables by Americans will likely increase, provided the current barriers to fresh produce consumption such as high cost, preparation time and limited availability are resolved. To meet the expected demand for safe and nutritious produce, the industry should act now to comply with the FDA’s produce safety rule through education, training and testing.

Are you prepared to comply with FSMA produce safety regulations? Mérieux NutriSciences offers an array of services to support the produce industry in their food safety efforts. From microbiology testing and environmental monitoring programs to nutrition labeling and chemistry testing, our experts provide the services you need to ensure the safety and quality of your products. Learn more about our services for the produce industry by downloading our sell sheet below.


Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

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