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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
September 28, 2023
The 2023 Final Guidance updates and finalizes the following sections of the original 2017 draft guidance:
- Cleaning and Sanitizing
- Agricultural Water in Sprout Operations
- Seeds for Sprouting
- Environmental Monitoring
The 2023 Draft Guidance re-issues certain sections of the original 2017 draft guidance and issues one new section for sprout operations as revised draft guidance. The following updated and new sections in the revised draft guidance are now available for comment:
- Equipment, Tools, and Buildings
- Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts)
- Personnel Qualifications, Training, and Hygienic Practices
Once finalized, the sections in the 2023 Draft Guidance will be incorporated into 2023 Final Guidance creating one complete final guidance document.
This draft guidance is intended for those persons (“you”) who grow, harvest, pack and/or hold sprouts covered by Subpart M of our final rule, published in the Federal Register (80 FR 74353) on November 27, 2015, entitled, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (the Produce Safety Rule or the Rule).
The Produce Safety Rule established for the first time U.S. Federal requirements for the growing, harvesting, packing, and holding of produce for human consumption, including sprouts (Title 21 Code of Federal Regulations part 112 (21 CFR part 112)). The Rule focuses on certain conditions and practices identified as common routes of contamination of produce (similar to the areas covered by the 1998 Guidance, “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs Guide)) (Ref. 1). The Rule establishes requirements addressing common routes of microbial contamination, including: agricultural water; biological soil amendments of animal origin; worker health and hygiene; equipment, tools, buildings and sanitation; and domesticated and wild animals.
Sprouts represent a distinct food safety concern because the conditions under which sprouts are produced (i.e., temperature, water activity, pH and available nutrients) are also ideal for the growth of pathogens, if present (Ref. 2). Between 1996 and 2020 in the United States, FDA observed 52 reported outbreaks of foodborne illness associated with sprouts. Together, it is estimated that these outbreaks resulted in at least 2700 cases of illness, 200 hospitalizations, and three deaths (Ref. 3, Ref. 4, Ref. 5, Ref. 6, Ref. 7, and Ref. 8). During this timeframe, sprouts have been associated with outbreaks of several different pathogens, including Salmonella spp., Listeria monocytogenes, E. coli O157:H7, and several types of non-O157:H7 pathogenic E. coli (i.e., E. coli O157:NM (H-), E. coli O104:H4, E. coli O26, E. coli O121, E. coli O103) (Ref. 9 and Ref. 10). In foodborne illness outbreaks associated with sprouts where the source of contamination was identified, epidemiological investigations often identify the most likely source of contamination as seeds used for sprouting (Ref. 2 and Ref. 11). However, poor sanitation and unhygienic practices at the sprout operation have also contributed to the contamination of sprouts (Ref. 2, Ref. 6, Ref. 12, Ref. 13, and Ref. 14).
Because the distinctive practices and conditions for growing sprouts present unique risks, we established sprout-specific requirements in Subpart M (Sprouts) of the Produce Safety Rule. Subpart M of the Rule builds on sprout production practices similar to areas covered in our 1999 Sprout Guidances (discussed further below, now withdrawn). Sprout operations subject to the Produce Safety Rule must comply with all applicable requirements in the Rule, including, but not limited to, all applicable requirements in Subpart M.
The requirements in the Produce Safety Rule are directed specifically to covered farms (as that term is defined in the Rule) that grow, harvest, pack or hold covered produce, including sprouts. Covered farms that grow, harvest, pack or hold sprouts are referred to in this guidance as “sprout operations,” or “you.” Produce that is covered by the Rule is referred to as “covered produce.”
Neither the Produce Safety Rule nor this draft guidance document is directed to growing, conditioning, or distributing seed for sprouting or to the handling of sprouts at a retail food establishment. However, as noted in our prior Sprout Guidances and our May 2009 letter to suppliers and distributors of seed for sprouting and sprout operations (Ref. 15 and Ref. 16), everyone in the sprout supply chain has a responsibility to help ensure food safety. FDA has also issued the final guidance document regarding good agricultural practices for seed for sprouting, entitled “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting: Guidance for Industry” (Ref. 17). The Produce Safety Rule does not address chemical or physical hazards. However, you have a responsibility to ensure that your sprouts are not adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. §§ 301 et seq.) and are produced in compliance with all applicable laws and regulations. Under section 402(a)(1) of the FD&C Act, a food is adulterated if it bears or contains any added poisonous or deleterious substance which may render it injurious to health, and such substances may include or otherwise result from physical and chemical (including radiological) contamination.
This draft guidance provides our current thinking and recommendations to assist sprout operations subject to the Produce Safety Rule primarily in complying with the sprout-specific requirements in Subpart M, specifically the requirements related to sampling and testing spent sprout irrigation water or in-process sprouts. This draft guidance accompanies the final guidance, Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption (Ref. 18), which discusses other requirements of Subpart M (e.g., seed treatment, environmental monitoring), which are covered in the finalized sections (Ref. 18). FDA is issuing this draft guidance to receive comments on revised sections of a currently issued draft guidance entitled “Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations” (January 23, 2017). After reviewing comments and incorporating any changes, FDA will combine the subjects discussed into this guidance into a single final guidance, as appropriate. This draft guidance also briefly discusses certain requirements (in Subpart L of the Rule relating to Equipment, Tools, Buildings, and Sanitation) of particular relevance to a sprout operation. In addition, this draft guidance may also be useful to sprout operations that are not subject to the Produce Safety Rule that voluntarily choose to follow the standards established in the Rule. In the development of this draft guidance, we particularly considered industry and international documents related to food safety and hygienic production of sprouts (Ref. 19, Ref. 20, and Ref. 21). We have incorporated aspects of these documents that are consistent with our laws, regulations, and existing policies.
Some of the material in this draft guidance relates to regulatory requirements of the Produce Safety Rule that are also covered in the draft “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry” (general produce compliance and implementation draft guidance (83 FR 53196) issued in October 2018) (Ref. 22). At the present time, the material on these overlapping topics (e.g., training, equipment, tools, and buildings) is consistent between these two draft guidance documents. This draft guidance focuses specifically on insights drawn from FDA’s experience with sprout operations, such as from inspections and sprout-associated foodborne illness outbreak investigations, and elaborates on how the broader training, equipment, tools, and buildings standards in part 112 could apply to and be implemented in a sprout operation.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- 2023 Final Guidance
- Original 2017 Draft Guidance
- Constituent Update: FDA Finalizes Draft Guidance for Sprout Operations under the Produce Safety Rule, Releases Certain Sections as Revised Draft Guidance (September 2023)
- FSMA Rule on Produce Safety
- Produce & Plant Products Guidance Documents & Regulatory Information