Description
This guidance is intended for those persons who are subject to the Sanitary Transportation of Human and Animal Food Rule (81 FR 20091), published on April 6, 2016. Specifically, this guidance provides clarification on the scope of the waiver for food establishments that provide food directly to consumers from the requirements of the Sanitary Transportation of Human and Animal Food Rule (the food establishment waiver) in response to questions the Agency has received since publication of the final rule.
Scope & Applicability
Product Classes
2Food intended for animal consumption subject to Part 507; Food for animal consumption manufactured, processed, packed, or held; Subject of the preventive controls regulation; Product manufactured by contract feed mills
Food intended for human consumption subject to Part 117; Food manufactured, processed, packed, or held
Stakeholders
6A truck or transport vehicle holding food only in its usual course of business
Person who arranges for the transportation of food; Entity responsible for establishing written procedures and specifications; A person who arranges for the transportation of food
The entity for which the identifier is unique in the Batch Sender Identifier field.
A charitable entity that prepares or serves food directly to the consumer.
Includes pet shelters, kennels, and veterinary facilities providing food to animals.; Establishment that prepares and sells food for immediate consumption
Businesses that provide food directly to consumers
Identified Hazards
Hazards
1conditions that will be unsafe for human or animal health
Related CFR Sections (1)
- 21CFR1.227§ 1.227 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, for the purposes of this subpart:Read full regulation →
Related Warning Letters (1)
- 2023-03-07
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Arrow Reliance Inc.
See Also (8)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- 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)
- CPG Sec 100.250 Food Facility Registration (Human and Animal Food) (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Determination of Status as a Qualified Facility (Status: Final)
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (Status: Draft)
- Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)