Questions about the safety of fresh produce are in the headlines again following recent North American outbreaks involving Salmonella in sprouts, Salmonella in papayas and E. coli O157:H7 linked to romaine lettuce. Moreover, the Produce Safety rule of the Food Safety Modernization Act (FSMA) took effect for large farms in January, and the U.S. Food and Drug Administration (FDA) implemented the next stage of its targeted sampling program for fresh produce and related commodities.

As the agency shines a spotlight on produce safety, the industry has expressed concerns about the scientific basis of certain requirements, including the water testing mandate and the FDA’s current zero tolerance policy for Listeria monocytogenes on raw agricultural commodities.

In order to understand the current issues surrounding the implementation of new produce safety regulations, it is important to consider the following three questions:

1) How is the FDA targeting microbial hazards in fresh produce?

Under FSMA, the FDA is implementing a risk-based and preventive approach to food safety. Towards this goal, the agency has begun sampling for microbial hazards in certain agricultural commodities previously associated with outbreaks. In recent years, the program has included the sampling of sprouts, whole fresh avocados, raw milk cheese, cucumbers, hot peppers, fresh herbs, guacamole and processed avocado.

During the current fiscal year, the FDA has been sampling fresh herbs, specifically basil, parsley and cilantro to test for Salmonella, Shiga toxin producing E. coli (STEC) and possibly Cyclospora cayetanensis. Fresh herbs were selected for targeted sampling due to their use in multi-ingredient foods without being subjected to a kill step. Basil, parsley and cilantro were implicated in nine outbreaks that involved 2,699 illnesses between the years 1996 and 2015.

The FDA also declared that processed avocado and guacamole samples will be tested for Salmonella and Listeria monocytogenes.  Avocado, avocado products or guacamole were identified as the vehicles for 12 outbreaks that occurred in the U.S. between 2005 and 2015.

On February 23, the agency issued the first quarterly report of its FY18-19 sampling program for fresh herbs. To date, the FDA reported the collection of 35 domestic samples for microbiological testing but reported no positive results. The collection and testing of 104 import samples of fresh herbs resulted in four positive results for Salmonella and three positive results for STEC, however no samples tested positive for E. coli O 157:H7. The testing of processed avocado and guacamole for Listeria monocytogenes resulted in three positive samples among 58 domestic samples and one positive sample for the pathogen in 49 imported samples.

The FDA intends to collect 1,600 samples per assignment over the course of 18 months. The agency has indicated that positive results during the sampling program may result in enforcement actions, including recalls or public warnings.

2) What is the controversy surrounding water testing and microbial standards?

On January 26, 2018, large farms, other than sprout operations, were required to comply with the FSMA rule, Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption, which established the first federal science-based minimum standards to ensure the safe growing, harvesting, packing and holding of raw agricultural commodities.

Microbial quality standards and the establishment of a microbial water quality profile for agricultural water were emphasized within the produce safety rule. The United Fresh Produce Association (United Fresh) and other industry associations have expressed concerns about the actual benefits of the prescribed agricultural water testing program in terms of food safety.

Last fall in an article for Food Safety Magazine, Jennifer McEntire Ph.D. of United Fresh and Jim Gorny Ph.D. evaluated the issues surrounding the monitoring of agricultural water to ensure its “adequate microbial quality” for the intended use.   

Due to industry concerns about the microbial quality and testing requirements, the FDA proposed a two-year extension of the compliance dates and announced plans to work with industry stakeholders to simplify the requirements. As proposed, the deadline for large produce farms to test untreated surface water would be extended until January 2022. However, large produce farms are expected to initiate baseline testing programs for establishing a microbial water quality profile following the compliance date for the rule, which was January 26, 2018.  

3) Should the FDA impose a ‘zero tolerance’ policy for Listeria monocytogenes?

Under the current CGMP and preventive controls rule (21 CFR 117.3), the FDA defined a ready-to-eat (RTE) food as “any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.” Given this definition, how should the industry address the risk of Listeria monocytogenes in fresh produce that lacks a processing step for eliminating the hazard?

Listeria monocytogenes is a naturally occurring risk on produce farms. Recently, the leading produce industry trade groups prepared a joint statement to urge the FDA to reconsider its current regulatory policy concerning this pathogen and fresh produce. The Produce Marketing Association (PMA), United Fresh and other groups submitted public comments to ask the agency to exempt or establish a tolerance level for Listeria monocytogenes (Lm) in fresh produce, “as there are no known preventive controls that can be implemented to reduce, control or eliminate Lm on fresh produce during growing operations in open fields.”

The produce industry understands the challenges of establishing a numeric regulatory limit and recognizes the value of preventive controls to manage the risk of pathogens during fresh produce postharvest handling and fresh-cut processing operations. The industry groups have stated the current FDA zero tolerance approach to Listeria monocytogenes in fresh produce is not achievable.

Knowledge is Power

Regulators, scientists and produce industry advocates can all agree that establishments covered by the Produce Safety rule must understand their hazards. Although the FDA is not planning to begin routine Produce Safety inspections until Spring 2019, all FDA-regulated facilities should prepare for the new FSMA approach to facility inspections in which “swabathons” are conducted for environmental pathogens.

Food manufacturers can prepare to comply with the Produce Safety Rule under FSMA by implementing a comprehensive environmental monitoring program. Tracking every area within your production environment for the presence of Listeria monocytogenes will enable you to detect the pathogen early-on and take corrective actions to prevent product contamination. EnviroMap®, Mérieux NutriSciences’ cloud-based environmental monitoring solution, automates scheduling, mapping and tracking sampling procedures to provide actionable data. Pure Pacific Organic, one of food industry’s leading produce suppliers, recently implemented EnviroMap® to better align themselves with FDA Listeria requirements. Download our case study to learn how the software helped them improve their environmental monitoring program.

 

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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