Description
The FDA Food Safety Modernization Act of 2011 (FSMA)directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On April 6, 2016, FDA published in theFederal Registera final rule,Sanitary Transportation of Human and Animal Food(Sanitary Transportation rule) (81 FR 20091), that establishes requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. The final rule became effective on June 6, 2016.
Scope & Applicability
Product Classes
3Substances used in human food evaluated for safety.; Substances intended for use in food for humans.
Not considered a major food allergen under the FD&C Act.
Substances used in animal food evaluated for safety.; Substances intended for use in food for animals.
Stakeholders
6Person who arranges for the transportation of food; Entity responsible for establishing written procedures and specifications; A person who arranges for the transportation of food
A truck or transport vehicle holding food only in its usual course of business
Person that loads food onto a motor or rail vehicle; Entity responsible for verifying conditions before loading food; A person that loads food onto a motor or rail vehicle
The entity for which the identifier is unique in the Batch Sender Identifier field.
Entity type with specific compliance dates
Person identified to perform FSVP activities on the importer's behalf; person performing FSVP activities; person with education, training, or experience to perform FSVP activities; Person with education, training, or experience to perform FSVP activities; Person required to conduct or oversee hazard analysis; Person with education, training, or experience to perform FSVP activities.; person required to conduct and document verification activities; person with expertise to review and assess verif
Regulatory Context
Attributes
3Condition determining if transportation regulation applies
Temperature sufficient to ensure food safety during transport
12 months beyond use or termination of agreements
Identified Hazards
Hazards
5Required to prevent food from becoming unsafe during transport
Objectionable animals or insects including birds, rodents, flies, and larvae
Awareness required during training
Risk of contamination in bulk vehicles or unenclosed food; Unintentional incorporation of a food allergen
Failure to maintain required temperature during transport
Related CFR Sections (8)
- 21CFR1.910§ 1.910 What training requirements apply to carriers engaged in transportation operations?
(a) When the carrier and shipper have agreed in a written contract that the carrier is responsible, in whole or in part, for the sanitary conditions during transportation operations, the carrier must provide adequate training to personnel engaged in transportation operations that provides an awareneRead full regulation →
- 21CFR1.900§ 1.900 Who is subject to this subpart?
(a) Except for non-covered businesses as defined in § 1.904 and as provided for in paragraph (b) of this section, the requirements of this subpart apply to shippers, receivers, loaders, and carriers engaged in transportation operations whether or not the food is being offered for or enters interstatRead full regulation →
- 21CFR1.908§ 1.908 What requirements apply to transportation operations?
(a) General requirements.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 →
- 21CFR1.930§ 1.930 When will a waiver that we grant become effective?
Any waiver that we grant will become effective on the date that notice of the waiver is published in the Federal Register .Read full regulation →
- 21CFR1.906§ 1.906 What requirements apply to vehicles and transportation equipment?
(a) Vehicles and transportation equipment used in transportation operations must be so designed and of such material and workmanship as to be suitable and adequately cleanable for their intended use to prevent the food they transport from becoming unsafe, i.e., adulterated within the meaning of sectRead full regulation →
- 21CFR1.912§ 1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
(a) Shippers must retain records:Read full regulation →
- 21CFR1.904§ 1.904 What definitions apply to this subpart?
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. The following definitions also apply:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-03-18
Foreign Supplier Verification Program (FSVP)
Zacanta LLC
- 2024-10-08
Foreign Supplier Verification Program (FSVP)
Green Day Produce, Inc.
- 2024-09-24
Acidified Foods/Emergency Permit Control/Adulterated
Brewing Market Coffee
- 2024-08-27
Foreign Supplier Verification Program (FSVP)
Minland of Texas, Inc.
- 2024-05-21
FSVP/Seafood HACCP
Rash Catering Services, LLC
- 2023-10-10
Foreign Supplier Verification Program (FSVP)
Ikal LLC
- 2023-01-24
Foreign Supplier Verification Program (FSVP)
TL State Management, Inc.
- 2022-12-13
Foreign Supplier Verification Program (FSVP)
Gobwa Exotic Imports Inc.
- 2022-08-16
Foreign Supplier Verification Program (FSVP)
EH Maldonado and Company
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- CPG Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture, Auricular Stimulation, etc. (CPG 7133.21) (Status: Final)
- Guidance for Industry: Seafood HACCP Transition Guidance (Status: Final)
- Guidance for Industry: Implementation of Section 10809 of the Farm Security and Investment Act of 2002 Regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated with Irradiation (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff (Status: Final)
- User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide - Guidance for Industry (Status: Final)
- Time and Extent Applications for Nonprescription Drug Products (Status: Final)