Description
On January 4, 2011, President Obama signed the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) into law. As a component of FSMA’s overhaul of U.S. food safety law to better ensure the safety and security of the nation’s food supply, section 204(d) of FSMA requires that FDA establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods the Agency designates as high-risk to facilitate the rapid and effective traceability of such foods. These recordkeeping requirements are additional to the food traceability requirements under section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (added to the FD&C Act in title III, subtitle A, section 306, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188)) and the implementing regulations in subpart J ofpart 1 of title 21 of the Code of Federal Regulations(§§ 1.326 to 1.368) (the subpart J regulations). In section 204(d)(1) of FSMA, Congress directed FDA to adopt additional recordkeeping requirements to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death to humans or animals resulting from certain foods being adulterated under section 402 of the FD&C Act or misbranded with respect to allergen labeling under section 403(w) of the FD&C Act.
Scope & Applicability
Product Classes
5Sprouts in their raw or natural state
Raw Agricultural Commodities
Specific 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
Subject to specific exemptions based on hen count or treatment
RACs; Fruits and vegetables subject to section 419 standards; Referred to as RACs in the context of packing and holding.
Stakeholders
10Charitable entities like food banks and soup kitchens
A person who has possession of food for the sole purpose of transporting it.
Source of food with specific receipt record exemptions
Exempt from certain transformation recordkeeping for foods not shipped; Entity type with specific spreadsheet exemptions based on sales; Facility that prepares and sells food directly to consumers for immediate consumption.
Exempt from certain traceability lot code assignment requirements; Entity type with specific spreadsheet exemptions based on sales; Establishment that sells food products directly to consumers.
The person who first receives food from a fishing vessel on land.; Person taking possession of food for the first time on land from a fishing vessel.
The person who first packs a raw agricultural commodity.
Target audience for the compliance guide
Exemption based on annual monetary value of food sold
Entities involved in commercial food preparation
Regulatory Context
Attributes
3Specific location data required for farm maps.
Key contact information for the location where food is handled.
Criterion for granting a regulatory waiver; Basis for requesting or maintaining a waiver
Identified Hazards
Hazards
3Risks the Food Traceability Rule aims to prevent or mitigate.
Public health risk the rule aims to mitigate; Public health threat requiring rapid identification of recipients
Pathogens that commercial processing must adequately reduce
Related CFR Sections (20)
- 21CFR1.328§ 1.328 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) ( 21 U.S.C. 321 ) apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
- 21CFR1.1465§ 1.1465 How will FDA update the Food Traceability List?
(a) When FDA tentatively concludes, in accordance with section 204(d)(2) of the FDA Food Safety Modernization Act, that it is appropriate to revise the Food Traceability List, we will publish a notice in the Federal Register stating the proposed changes to the list and the reasons for these changes Read full regulation →
- 21CFR1.1460§ 1.1460 What consequences could result from failing to comply with the requirements of this subpart?
(a) Prohibited act. The violation of any recordkeeping requirement under section 204 of the FDA Food Safety Modernization Act, including the violation of any requirement of this subpart, is prohibited under section 301(e) of the Federal Food, Drug, and Cosmetic Act, except when such violation is comRead full regulation →
- 21CFR1.1455§ 1.1455 How must records required by this subpart be maintained and made available?
(a) General requirements for records.Read full regulation →
- 21CFR1.1425§ 1.1425 What must be included in a petition requesting a waiver for a type of entity?
In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter , a petition requesting a waiver for a type of entity must:Read full regulation →
- 21CFR1.1420§ 1.1420 What process applies to a request for a waiver for an individual entity?
(a) After considering the information submitted in a request for a waiver for an individual entity, we will respond in writing to the person that submitted the waiver request stating whether we are granting the waiver (in whole or in part) and the reasons for the decision.Read full regulation →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
- 21CFR1.1360§ 1.1360 Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?
(a) General. Except as specified in paragraph (b) of this section, FDA will modify the requirements of this subpart applicable to a food or type of entity, or exempt a food or type of entity from the requirements of this subpart, when we determine that application of the requirements that would otheRead full regulation →
- 21CFR1.1330§ 1.1330 What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?
(a) Except as specified in paragraph (c) of this section, for each traceability lot of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List you initially pack, you must maintain records containing the following information and linking this infRead full regulation →
- 21CFR1.1350§ 1.1350 What records must I keep when I transform a food on the Food Traceability List?
(a) Except as specified in paragraphs (b) and (c) of this section, for each new traceability lot of food you produce through transformation, you must maintain records containing the following information and linking this information to the new traceability lot:Read full regulation →
- 21CFR1.1345§ 1.1345 What records must I keep when I receive a food on the Food Traceability List?
(a) Except as specified in paragraphs (b) and (c) of this section, for each traceability lot of a food on the Food Traceability List you receive, you must maintain records containing the following information and linking this information to the traceability lot:Read full regulation →
- 21CFR1.1340§ 1.1340 What records must I keep and provide when I ship a food on the Food Traceability List?
(a) For each traceability lot of a food on the Food Traceability List you ship, you must maintain records containing the following information and linking this information to the traceability lot:Read full regulation →
- 21CFR1.1335§ 1.1335 What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?
For each traceability lot of a food obtained from a fishing vessel for which you are the first land-based receiver, you must maintain records containing the following information and linking this information to the traceability lot:Read full regulation →
- 21CFR1.1325§ 1.1325 What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?
(a) Harvesting.Read full regulation →
- 21CFR1.1320§ 1.1320 When must I assign traceability lot codes to foods on the Food Traceability List?
(a) You must assign a traceability lot code when you do any of the following: Initially pack a raw agricultural commodity other than a food obtained from a fishing vessel; perform the first land-based receiving of a food obtained from a fishing vessel; or transform a food.Read full regulation →
- 21CFR1.1315§ 1.1315 What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
(a) If you are subject to the requirements in this subpart, you must establish and maintain a traceability plan containing the following information:Read full regulation →
- 21CFR1.1300§ 1.1300 Who is subject to this subpart?
Except as otherwise specified in this subpart, the requirements in this subpart apply to persons who manufacture, process, pack, or hold foods that appear on the list of foods for which additional traceability records are required in accordance with section 204(d)(2) of the FDA Food Safety ModernizaRead full regulation →
- 21CFR1.1305§ 1.1305 What foods and persons are exempt from this subpart?
(a) Exemptions for certain small producers.Read full regulation →
- 21CFR1.1310§ 1.1310 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, the following definitions apply to words and phrases as they are used in this subpart:Read full regulation →
- 21CFR112.4§ 112.4 Which farms are subject to the requirements of this part?
(a) Except as provided in paragraph (b) of this section, a farm or farm mixed-type facility with an average annual monetary value of produce (as “produce” is defined in § 112.3 ) sold during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as thRead full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 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
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 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
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
- 2025-06-10
Foreign Supplier Verification Program (FSVP)
Gongora USA Corp
- 2025-06-03
Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Jack & The Green Sprouts, Inc.
- 2025-06-03
Foreign Supplier Verification Program (FSVP)
Amore Produce, LLC
See Also (8)
- Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (Status: Final)
- Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (Status: Final)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)