The FDA has issued final guidance for those producing and using seeds for sprouting, partly because of a string of foodborne illness outbreaks stretching back more than two decades.

“Contamination can occur at any point in the supply chain, but the seeds themselves are the most likely source of contamination in many of these outbreaks,” according to the Food and Drug Administration.

The guidance gives companies recommended steps to prevent adulteration throughout the production chain. Contaminated seeds mean contaminated sprouts, which can cause serious illnesses.

There were at least 52 outbreaks associated with contaminated sprouts between 1996 and 2020. At least 2,700 people were sickened — and likely thousands more based on the multiplier equation developed by the Centers for Disease Control and Prevention.

Raw and lightly cooked sprouts are considered a dangerous food, with public health officials recommending against eating them. People at particular risk include older people, pregnant women, children and anyone with a compromised immune system.

An abbreviated list of outbreaks traced to sprouts in recent years includes:

  • 2019 and 2020 — an E. coli O103 outbreak linked to raw sprouts at Jimmy John’s restaurants sickened at least 22 people in Iowa. 
  • 2018 — Another Jimmy John’s outbreak, this time caused by Salmonella Montevideo, sickened at least 10 people in three states.
  • 2016, a Salmonella Muenchen and Salmonella Kentucky outbreak linked to raw alfalfa sprouts sickened at least 26 people in 12 states.

Between November 2015 and May 2016, contaminated seed was associated with a multistate outbreak of Salmonella. The outbreak investigation traced the underlying cause to a single contaminated seed lot, which had been sprouted by several different sprout operations throughout the United States. After positive test results for multiple serotypes of Salmonella were obtained from this seed lot and from sprouts grown from this seed lot, the entire seed lot was recalled.

“In addition, based on the epidemiological information and traceback data from FDA’s analysis of 14 sprout outbreaks that occurred in the United States between 2012 and 2020, FDA found that contaminated seed was the likely cause of most sprout-related outbreaks during this timeframe,” according to the guidance document.

“. . . The problem is that the sprouting environment, which is moist and warm, is the perfect environment for bacterial growth. Then, the seeds can have bacteria inside the seed coat, which means that cleaning methods are ineffective,” according to the FDA.

“While the Produce Safety Rule (PSR) includes sprout-specific requirements, the FDA does not considered seed for sprouting (to be) covered produce. So the growing, conditioning, and distribution of seed for sprouting is not covered by the PSR.”

The final guidance recommends that everyone in the sprout business become as informed as possible about food safety practices, processes, and procedures followed by the firms that sell seeds. The practices and conditions appropriate for producing seeds for sprouting will have a higher level of food safety precautions than those for producing seed used for other purposes.

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