Description
This draft guidance is intended for those persons (“you”) who grow, harvest, pack and/or hold sprouts covered by Subpart M of our final rule, published in the Federal Register (80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).
Scope & Applicability
Product Classes
4Specific requirements for growing, harvesting, packing and holding; Specific produce category with unique compliance dates and requirements; Specific category often excluded from general pre-harvest water assessments; Specific produce category with unique vulnerability to microbes; Operations with shorter compliance timelines
Sprouts in their raw or natural state
Products distinguished from sprouts by growth stage and not subject to Subpart M; Compared against sprouts in policy discussions
Mature crops like wheat and soybeans not falling under produce definition
Stakeholders
9Entities with specific compliance timelines
obtain documentation from your seed supplier; Entity providing seeds and potentially providing Certificates of Conformance.
Entity responsible for ensuring appropriate test methods are used
Entities that assign lot numbers to seed packages.
training in aseptic techniques is recommended for the sample collector
Person responsible for monitoring or following corrective action instructions
Personnel requiring additional training on recognizing contaminated produce
Personnel assigned to ensure compliance by individuals with the requirements of part 121
Entities to whom direct sales may lead to a qualified exemption
Regulatory Context
Attributes
6Financial threshold for determining covered farm status
Recommended temperature range for holding and shipping samples
A characteristic of sampling required to ensure statistical confidence.
maintain the cold chain as much as possible
condition monitored by instruments
A specific quantity of sprouts used for tracking and testing purposes
Identified Hazards
Hazards
8risk in multidose drug products
Localized areas of contamination more likely in stationary growing units.
Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination
undesirable reversal of water flow causing contamination
Pathogens in ready-to-eat food exposed to environment
biological hazard in frozen ice cream novelty; Biological hazard in cheese
Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Pathogens that commercial processing must adequately reduce
Related CFR Sections (20)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR112.150§ 112.150 Under this subpart, what requirements apply regarding records?
(a) You must establish and keep records required under this subpart in accordance with the requirements of subpart O of this part .Read full regulation →
- 21CFR112.21§ 112.21 What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?
All of the following requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces:Read full regulation →
- 21CFR112.142§ 112.142 What requirements apply to seeds or beans used to grow sprouts?
In addition to the requirements of this part, all of the following requirements apply to seeds or beans used to grow sprouts.Read full regulation →
- 21CFR112.147§ 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?
All of the following requirements apply for collecting and testing samples of spent sprout irrigation water or sprouts for pathogens as required in § 112.144(b) :Read full regulation →
- 21CFR112.144§ 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?
All of the following testing must be done during growing, harvesting, packing, and holding sprouts:Read full regulation →
- 21CFR112.153§ 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c) ?
You must test spent sprout irrigation water (or sprouts) from each production batch for pathogens using:Read full regulation →
- 21CFR112.148§ 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?
You must, at a minimum, take the following actions if the samples of spent sprout irrigation water or sprouts test positive for E. coli O157:H7, Salmonella species, or a pathogen meeting the criteria in § 112.144(c) :Read full regulation →
- 21CFR112.125§ 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?
Equipment that is subject to this subpart that you use to transport covered produce must be:Read full regulation →
- 21CFR112.123§ 112.123 What general requirements apply regarding equipment and tools subject to this subpart?
All of the following requirements apply regarding equipment and tools subject to this subpart:Read full regulation →
- 21CFR112.143§ 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?
You must take all of the following measures for growing, harvesting, packing, and holding sprouts:Read full regulation →
- 21CFR112.116§ 112.116 What measures must I take when using food-packing (including food packaging) material?
(a) You must use food-packing material that is adequate for its intended use, which includes being:Read full regulation →
- 21CFR112.124§ 112.124 What requirements apply to instruments and controls used to measure, regulate, or record?
Instruments or controls you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), sanitizer efficacy or other conditions, in order to control or prevent the growth of microorganisms of public health significance, must be:Read full regulation →
- 21CFR112.121§ 112.121 What equipment and tools are subject to the requirements of this subpart?
Equipment and tools subject to the requirements of this subpart are those that are intended to, or likely to, contact covered produce; and those instruments or controls used to measure, regulate, or record conditions to control or prevent the growth of microorganisms of public health significance. ERead full regulation →
- 21CFR112.132§ 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?
All of the following requirements apply to the control and disposal of trash, litter, and waste in areas used for covered activities:Read full regulation →
- 21CFR112.131§ 112.131 What must I do to control and dispose of sewage?
All of the following requirements apply for the control and disposal of sewage:Read full regulation →
- 21CFR112.133§ 112.133 What requirements apply to plumbing?
The plumbing must be of an adequate size and design and be adequately installed and maintained to:Read full regulation →
- 21CFR112.32§ 112.32 What hygienic practices must personnel use?
(a) Personnel who work in an operation in which covered produce or food contact surfaces are at risk of contamination with known or reasonably foreseeable hazards must use hygienic practices while on duty to the extent necessary to protect against such contamination.Read full regulation →
- 21CFR112.130§ 112.130 What requirements apply for hand-washing facilities?
All of the following requirements apply to hand-washing facilities:Read full regulation →
- 21CFR112.129§ 112.129 What requirements apply to toilet facilities?
All of the following requirements apply to toilet facilities:Read full regulation →
Related Warning Letters (10)
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)