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FDA Publishes Draft Guidance For Sprout Seed Producers

Sprouts are associated with numerous foodborne illness outbreaks. According to the U.S. Food and Drug Administration (FDA), more than 2,600 documented illnesses have been associated with consuming contaminated sprouts since 1996. Much of the challenge to controlling risks lies in the fact that seeds are often the source of contamination in sprout products. In FDA’s Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (the Produce Safety Rule), the agency established regulations intended to prevent the introduction of known or reasonably foreseeable hazards in sprout operations (Subpart M). However, Subpart M does not address hazards associated with sprout seeds because FDA did not believe that growing, conditioning, and distributing seed to be “covered activities” under the Produce Safety Rule.

Recognizing that sprout seeds are a significant source of microbial contamination, on June 24th, FDA released a draft guidance document, Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting (Draft Guidance), with recommendations to growers, holders, conditioners, and distributors of sprout seeds to prevent them from being adulterated.

FDA has some general guidance for companies and individuals in the sprout seed supply chain, including growers, conditioners, packers, holders, and distributors.  This guidance includes:

  • Take steps to educate and train personnel who have food safety responsibilities on the principles of food hygiene, food safety, and personal health and hygiene;
  • Provide adequate, clean, and well-maintained toilet and hand-washing facilities to personnel;
  • Encourage good hygiene practices among personnel;
  • Store seed for sprouting separately from seed for other uses;
  • Ensure that food contact surfaces are cleanable. Food contact surfaces are those surfaces that contact human food (including seeds for sprouting) and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations;
  • Clean food contact surfaces regularly and sanitize them as appropriate. For example, clean and sanitize food contact surfaces before their use to contact lots of seed for sprouting, and between individual lots of seed for sprouting, to minimize potential cross-contamination between lots; and
  • Ensure that seed is transported in a manner that minimizes the likelihood of contamination with pathogens. For example, choose transportation vehicles and equipment that are suitable for their intended use and cleanable; and take measures to segregate, isolate, or use packaging to protect seeds for sprout production from contamination by other foods or non-food items in the same load or previous loads.

The Draft Guidance also has instructions specific to sprout seed growers.  As a general matter, FDA recommends that sprout seed growers adopt good agricultural practices (GAP) or conform with international standards, such as the Codex Alimentarius International Code of Hygienic Practice for Fresh Fruits and Vegetables. Additionally, FDA recommends the following for sprout seed growers:

  • If you use biological soil amendments of animal origin (e.g., manure) in seed growing fields, you should only use them in such a way that they do not contaminate the seed for sprouting. For example, we recommend that you treat any such soil amendments to ensure they do not contain pathogens of public health concern.
  • You should assess the relevant areas used for growing seed for evidence of potential contamination of seed as needed during the growing season (based on your seed, your practices and conditions, and your observations and experience). If significant evidence of potential contamination is found (such as observation of animals, animal excreta or crop destruction), we recommend that you evaluate whether or not the seed should be harvested. If any seed should not be harvested because it is reasonably likely to be contaminated (for example, if it is visibly contaminated with animal excreta), we recommend that you take measures to assist you later during harvest so you can identify, and not harvest the affected seed. For example, you might mark the affected area in a manner that will ensure it is not harvested, even if weather events or other occurrences remove the evidence, so it is not visible later during harvest.
  • You should ensure that water used for irrigation of areas where you grow seed for sprouting is safe and of adequate sanitary quality for its intended use. For example, if you learn that your irrigation water has tested positive for a pathogen of public health significance (e.g., Salmonella or E. coli O157:H7), we recommend that you consider treating your water to eliminate the pathogen or changing your water source.

The Draft Guidance also provides recommendations specific to sprout seed packers and holders:

  • Seed should be stored in closed or covered containers, in a clean, dry area dedicated to seed storage. We recommend that containers be positioned off the floor and away from walls to reduce the possibility of contamination by rodents or other pests and to facilitate regular monitoring for pest problems.
  • You should use appropriate packaging for seeds to minimize potential for contamination.

 FDA will be accepting public comments on the draft guidance until August 26th.

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