Food Safety Modernization Act produce testing has yet to get around to romaine

Analysis

Public interest in the safety of romaine has increased during the past year as Canada and the United States have experienced three back-to-back outbreaks of E. coli O157:H7 tied to the leafy green. 

Many people are surprised to learn that a bacteria generally thought of as beginning in the guts of cows is ending up in their salad bowls. But that’s what’s happening, with seven dead out of 350 sickened with E. coli infections. There have been 162 patients hospitalized and 31 treated for kidney failure.

The romaine crisis might have you wondering about just how much risk of E. coli O157:H7 might exist from eating romaine. You might be searching for related data that might exist out there. Good luck.

Before 2012, the U.S. Department of Agriculture sponsored about a dozen university labs that conducted tests on fresh produce in their areas as various crops were harvested. The industry did not like it much, and for the government, it was a tiny program costing only about $5 million a year.

The USDA’s Microbiological Data Program (MDP) was “zeroed out” of the budget, though, and two years later the U.S. Food and Drug Administration (FDA) started to pick up the slack with it Microbiological Surveillance Sampling (MSS) approach.

“As part of the FDA’s risk-based and preventive approach to food safety, which is at the core of the FDA Food Safety Modernization Act, the agency began developing a new, more robust approach to deploying its sampling resources in 2014,” according to the agency’s official website. “As the agency moves forward with this approach, it will continue to refine procedures based on lessons learned. The goals of the surveillance sampling are to keep contaminated products from reaching consumers and to facilitate a greater understanding of hazards.”

Rather than follow the harvest around the country as the MDP did, the MSS program takes a different approach.

Commodities sampled
Beginning in 2014, the FDA targeted sprouts, whole fresh avocados, and raw milk cheese that was aged for 60 days during the first year of the MSS program. The FDA collected more than 800 samples of each commodity and tested them for Salmonella, Listeria monocytogenes and E. coli O157:H7.

Cucumbers and hot peppers were tested beginning in 2016 for Salmonella and E. coli O157: H7 with 1,600 samples taken for each commodity. Tests were also conducted for Shiga toxin producing E. coli.

The MSS program checked fresh herbs, including basil, parsley, and cilantro, to test for Salmonella, Shiga toxin producing E. coli starting in 2018.

The FDA released reports on Dec. 7 for the sampling of whole, fresh avocados, and hot peppers. Like earlier tests, its work with avocados and hot peppers was to determine how frequently harmful bacteria is found in each commodity.

The MSS program tested 1,615 samples from both domestic and imported hot peppers. It found that 46 of the samples, or 2.85 percent, were positive for Salmonella. Just one was positive for STEC, but further testing found it was not the kind likely to cause a severe human illness.

It also took 1,615 samples of fresh avocados, testing for both for Salmonella and Listeria. Only 12 of the samples, or 0.74 percent, tested positive for Salmonella. Pulp testing showed 3, or less than 1 percent, positive for Listeria. However, 64 or 17.73 percent were positive for Listeria when the avocado skins were tested.

FDA claims it works with the “responsible farms” when it receives positive test results and the MSS has resulted in recalls and grower and packinghouse inspections. Likewise, when foreign produce tested positive, FDA has initiated import alerts to stop the commodities at ports of entry.

FDA also reports testing 407 domestic and 276 imported fresh herb samples. No E. coli O157 was found in any of the herb samples. Two domestic and four imported herbs tested positive for non-severe STEC. Four domestic and five imported Herb samples tested positive for Salmonella. And four — two domestic and two foreign — samples tested positive for Cyclospora cayetanensis.

Finally, the FDA reports testing 386 domestic and 88 imported avocado/guacamole samples, finding 11 positive for Listeria. No Salmonella was found.

FDA says it will evaluate the data or results generated throughout the sample collection period and use the data to inform the agency’s short and long-term decision making. By developing these data sets, the FDA seeks to identify potential vulnerabilities and ways to enhance the food safety system.

FDA may react to the data or take certain steps, such as:

• Decreasing sampling, if few positive samples are obtained;
• Implementing more targeted sampling if trends are identified; for example, if positive samples come from a specific geographic region, a specific facility, or during a particular season;
• Follow-up inspections;
• Working with state or international regulatory partners to take corrective actions and implement preventive controls;
• Developing new or enhanced industry guidance; and
• Conducting outreach and information sharing to better protect consumers.

But like the man in the song who had no bananas, the MSS has no romaine data. So, good luck with that.

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