FDA Issues Draft Guidance for Seed for Sprouting

FDA Issues Draft Guidance for Seed for Sprouting

Guidance intended to reduce food safety hazards in production.

June 25, 2019

FDA has issued draft guidance to provide recommendations to those in the sprout seed industry to help reduce food safety hazards in the production of seed used for sprouting.

Between January 1996 and August 2018, contaminated sprouts were associated with 50 outbreaks, which together resulted in more than 2,600 cases of foodborne illness. Studies indicate that contaminated seed is the likely source of most sprout-related outbreaks.

Sprouts represent a special food safety concern because the conditions under which sprouts are produced (time, temperature, water activity, pH and available nutrients) are also ideal for the growth of pathogens, if present. Because the distinctive practices and conditions for growing sprouts present unique risks, the Produce Safety Rule, as required by the FDA 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. 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. 

In addition, although that the end use of seed may sometimes be unknown by the farmers who grow the seed and by the conditioners and distributors who handle the seed, seed for sprouting is considered “food” under the Federal Food, Drug, and Cosmetic Act. Therefore, the draft guidance is intended to provide food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting.

In this draft guidance, FDA recommends that seed for sprout production be grown using good agricultural practices (GAPs) or in conformance with international standards such as the Codex Alimentarius International Code of Hygienic Practice for Fresh Fruits and Vegetables, and that seed is packed and held under sanitary conditions. The draft guidance also recommends that all firms in the sprout seed supply chain take steps to reduce microbial food safety hazards in seed for sprouting, including training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, storing seed for sprouting separately from seed for other uses, and ensuring that food contact surfaces are cleanable and cleaned regularly.

In the development of the draft guidance, 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. Aspects of these documents were incorporated in the draft guidance.

The draft guidance will be available for public comment for 60 days starting June 25, 2019. Although comments can be submitted at any time, FDA recommends comments be submitted on or before August 26, 2019, to ensure it is considered during the development of the final version of this guidance. Comments can be submitted electronically at https://www/regulations.gov. 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.