Government Resources

SSA is pleased to provide selected links and downloadable content from U.S. and international government regulatory agencies and authorities. If you have suggestions for additional links, please email us at sproutalliance@iit.edu.

FSMA Rule for Produce Safety

In January 2013, FDA took the first steps towards creating new federal laws overseeing fruit and vegetable food safety as part of the Food Safety Modernization Act (FSMA) by publishing proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption in the Federal Register. The Rule was published on 11/27/2015.

You can view the Rule for Produce Safety online: www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm

Unless specifically exempt or excluded, such as by annual sales and/or sales and market channels, sprout growing operations would be subject to the sprout-specific requirements in subpart M. They would also be subject to all other requirements of the Proposed Rule for Produce Safety (exceptions are noted).

Does the FSMA Rule for Produce Safety apply to you? Information regarding Coverage and Exemptions/Exclusions for PART 112 can be found here: www.fda.gov/media/94332/download

Other Sprout Safety Guidelines

U.S. Food and Drug Administration (FDA)
Guidance for Industry: Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operation

Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds (1999)
Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production (1999)

Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption (2023)

PART 112—STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting (2022)

Fact Sheet: Responding to Results Obtained from Testing Spent Sprout Irrigation Water (or In-Process Sprouts) for E. coli O157:H7 or Salmonella to Meet the Requirements of the PSR

Fact Sheet: Determining Coverage under Subpart M of the Produce Safety Rule

Fact Sheet: Decision Tree for Test Methods Requirements of Salmonella and E. coli O157:H7 in SSIW (or Sprouts)

Testing Methodologies for E. coli O157:H7 and Salmonella Species in SSIW (or Sprouts)

Equivalent Testing Methodologies for Listeria species and Listeria monocytogenes in Environmental Samples

Equivalent Testing Methodologies for E. coli O157:H7 and Salmonella in SSIW or Sprouts Samples

Related FDA Announcements
FDA's Strategy for FSMA Training: Who Will Provide Training for the Food Industry? Public and Private Partners Working Together

The Preventive Controls for Human Food rule and Preventive Controls for Animal Food rule are now final, and compliance dates for some businesses begin in September 2016

Codex Alimentarius Committee (CAC)
Code of Hygienic Practice for Fresh Fruit and Vegetables. Annex II: Annex for Sprout Production (2003) 

Canadian Food Inspection Agency (CFIA)
Code of Practice for the Hygienic Production of Sprouted Seeds (2007) 
Food Safety Practices Guidance for Sprout Manufacturers (2008) 

Food Standards Australia New Zealand (FSANZ)
Proposal P1004: Primary Production and Processing Standard for Seed Sprouts Approval Report (2011) 

Food Safety Authority of Ireland
Guidelines on Safe Production of Ready-to-Eat Sprouted Seeds (Sprouts) (2011)