Beginning today, the FDA is accepting comments on proposed guidance designed to improve the safety of fresh sprouts, which have been responsible for at least 50 outbreaks in the past two decades.

The proposed guidance would apply to all entities in the food supply chain, from seed producers through distributors and on to those who grow and sell fresh sprouts. Guidance from the Food and Drug Administration includes suggested practices. If entities wish to follow other procedures, they must document that those processes are as effective as the FDA’s guidance.

Using international and domestic best practices data, the FDA developed the guidance “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” as part of its increased focus on prevention rather than response.

“The FDA is committed to taking swift action to respond to outbreaks related to sprouts and keep our food supply safe, but we also know that measures to prevent issues from happening in the first place are an important element of protecting consumers,” said Frank Yiannas, FDA deputy commissioner for food policy and response. 

Frank Yiannas

“By studying outbreaks related to sprouts over the years, we have been able to recommend changes in the industry to help lower the incidence of sprout-related outbreaks. Today’s new draft guidance is another critical step, like the Sprout Safety Alliance or sprout-specific requirements of the Produce Safety Rule, the agency is taking to prevent illnesses related to sprouts.”

Investigators linked 50 foodborne illness outbreaks to fresh sprouts between January 1996 and August 2018. Two of those outbreaks sickened more than 100 people in the United States just this past year. Overall, in the 22-year period, more than 2,600 people were confirmed with illnesses. Studies indicate that contaminated seed is the likely source of most sprout-related outbreaks, according to the FDA’s statement about the proposed guidance.

Sprouts are particularly likely to harbor and grow foodborne pathogens because of the conditions under which sprouts are produced — time, temperature, water activity, pH and available nutrients — are also ideal for the growth of pathogens. If seeds have not been grown, handled, stored and distributed properly, they can easily harbor foodborne pathogens that thrive when the seeds are sprouted.

Pathogens such as E. coli, Salmonella and Listeria grow especially well in the conditions used to sprout seeds, Yiannas said in the FDA announcement.

In developing the draft guidance, the FDA considered three documents related to food safety and hygienic production of seed for sprouting: the Codex Code of Hygienic Practice for Fresh Fruits and Vegetables Annex II, Annex for Sprout Production; the International Sprout Growers Association-Institute for Food Safety and Health’s “U.S. Sprout Production Best Practices”; and the European Sprouted Seeds Association Hygiene Guideline for the Production of Sprouts and Seeds for Sprouting. Elements of all three documents are among the provisions in the FDA proposed guidance.

The guidance states that if a grower, holder, conditioner, or distributor “reasonably believes that its seeds are expected to be used for sprouting, we recommend that the grower, holder, conditioner, or distributor take steps that are reasonably necessary to prevent those seeds from becoming contaminated.”

Although they are generally not consumed as seeds, seeds that are used for sprouting are considered food under federal law.

Fresh sprouts present such high risk and are produced in conditions unique compared with other fresh produce, the FDA has a special subset of rules for them. The Produce Safety Rule, which FDA was required to develop as part of the 2011 Food Safety Modernization Act (FSMA), includes sprout-specific requirements. 

“However, we consider the seeds used for sprouting to be outside the definition of ‘covered produce’ under the rule, and activities such as growing, conditioning, and distributing seeds to be outside the scope of ‘covered activities’ in the rule,” according to the FDA announcement. “Therefore, we did not prescribe specific requirements in the Produce Safety rule to prevent the introduction of known or reasonably foreseeable hazards into or onto seed during growing, harvesting, conditioning, or holding of seed.”

FDA wants all firms in the sprout seed supply chain take steps to reduce microbial food safety hazards in seed for sprouting, including training personnel who have food safety responsibilities. The agency also wants sprout businesses to have separate storage arrangements for seed intended to be used for fresh sprouts. Sprout seed businesses should also ensure that food contact surfaces are cleanable and cleaned regularly.

The federal government is accepting comments on the proposed sprout draft guidance from the public, businesses, academia and all other interested parties. During the 60-day comment period, comments can be submitted online, by fax, by personal courier or regular mail. The deadline is Aug. 26.

For instructions on how to submit your comments, please visit Draft Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.

Comments can be submitted electronically at https://www/ Comments can also be mailed to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-4534 listed in the notice of availability that publishes in the Federal Register.

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