May 27, 2024

FDA Announces Sprout Guidance: What Took so Long?

After eight multistate food poisoning outbreaks linked to raw sprouts in the past five years, the FDA is finally issuing draft guidance for comments to help sprout operations meet new standards that are designed to keep this product safe. Raw sprouts are often contaminated with pathogenic bacteria, and the damp and warm growing conditions are the perfect medium for bacterial growth.

The Produce Safety Rule, under the FDA Food Safety Modernization act of 2011, mandated new requirements for sprout operations. Sprouts are a unique food poisoning risk because the conditions under which they are grown are ideal for the growth of pathogenic bacteria.

Between 1996 and July 2016 there were 46 food poisoning outbreaks associated with sprouts in the United States. They caused 2472 illnesses, 187 hospitalizations, and three deaths.

The Produce Safety Rule requires that covered sprout operations take steps to prevent the introduction of dangerous microbes into seeds or beans used for sprouting. They must also test irrigation water (or, in-process sprouts in some cases) for some pathogens, and test the growing, harvesting, packing, and holding environment for the presence of Listeria species. Corrective actions must be taken when needed.

The Produce Safety Rule sets science-based standards for the safe growing, harvesting, packing, and holding of fruit and vegetables on farms for produce intended for human consumption.

The largest covered sprout operations must be compliance by January 26, 2017. Small and very small businesses have compliance dates of January 26, 2018 and January 28, 2019.

The most notable recent sproutbreaks include the E. coli O157:NM outbreak linked to Jack and the Green Sprouts raw alfalfa sprouts and alfalfa onion sprouts. That outbreak sickened nine people; seven in Minnesota and two in Wisconsin. And the fifth largest multistate food poisoning outbreak of 2016 was the Salmonella Muenchen and Salmonella Kentucky outbreaks linked to raw alfalfa sprouts produced by multiple facilities, including Sweetwater Farms in Inman, Kansas. The sprouts came from one contaminated seed lot.

In 2014, 111 people in 12 states were sickened with Salmonella infections in an outbreak linked to Wonton Foods bean sprouts. Also in 2014, an E. coli O121 outbreak linked to Jimmy John’s sandwiches made with Evergreen raw clover sprouts sickened 19 people in four states.

To protect yourself against food poisoning, even with these new regulations in place, people in high risk groups should not consume raw sprouts. That group includes the very young, the elderly, pregnant women, and those with compromised immune systems and chronic illnesses.

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