FSMA Preventive Controls for Animal Food: Complete 21 CFR 507 Guide

What Is 21 CFR Part 507?

21 CFR Part 507 is the FSMA regulation that applies preventive controls requirements to animal food facilities. It mirrors many concepts from the human food Preventive Controls rule (21 CFR Part 117) but is tailored to the unique aspects of animal food manufacturing. The rule recognizes that animal food hazards can differ from human food hazards and provides a framework for identifying and controlling those hazards.

The rule covers all types of animal food including pet food (dog food, cat food), livestock feed, poultry feed, aquaculture feed, and specialty animal food products. It includes both cGMP requirements (Subpart B) and preventive controls requirements (Subparts C through F).

Who Must Comply?

Facilities that must comply with the Preventive Controls for Animal Food rule include:

• Animal food manufacturers and processors
• Pet food companies
• Feed mills and feed manufacturers
• Rendering facilities
• Animal food packaging operations
• Warehouses and storage facilities holding animal food
• Both domestic and foreign facilities that supply animal food to the US market

Exemptions and Modified Requirements

Several categories of facilities are exempt or have modified requirements:

• Qualified facilities: Those with less than $1 million in average annual sales (adjusted for inflation) have modified requirements
• Farms: Farms that only manufacture, process, pack, or hold animal food for consumption by animals on that farm
• HACCP facilities: Facilities already subject to specific FDA HACCP regulations (seafood, juice)
• Establishments regulated by USDA: Facilities inspected by USDA under the Federal Meat Inspection Act or Poultry Products Inspection Act
• Facilities solely engaged in holding or storing: Holding facilities not involved in manufacturing or processing may only need to comply with Subpart B (cGMPs)

Animal Food Safety Plan Requirements

Every covered facility must develop and implement a written Animal Food Safety Plan that includes:

• Hazard analysis: Identification and evaluation of known or reasonably foreseeable hazards
• Preventive controls: Risk-based controls to significantly minimize or prevent identified hazards
• Monitoring procedures: Written procedures for monitoring preventive controls
• Corrective actions: Procedures for when preventive controls are not properly implemented
• Verification activities: Activities to validate and verify that preventive controls are effective

The Food Safety Plan must be prepared or overseen by a Preventive Controls Qualified Individual (PCQI) who has completed training equivalent to the FDA-recognized PCQI curriculum for animal food.

Hazard Analysis for Animal Food

The hazard analysis must consider hazards to both the target animal and to humans who handle the animal food:

• Biological hazards: Salmonella, E. coli, Listeria, and other pathogens that may affect animals or handlers
• Chemical hazards: Mycotoxins (aflatoxin, vomitoxin), pesticide residues, heavy metals, drug residues, and dioxins
• Physical hazards: Metal fragments, stones, glass, and other foreign materials
• Radiological hazards: Where applicable based on ingredient sourcing

Types of Preventive Controls

Supply Chain Program

If your hazard analysis identifies a hazard that will be controlled by your supplier rather than your facility, you must implement a supply chain program:

• Approve suppliers based on their ability to control identified hazards
• Determine and conduct appropriate verification activities (audits, testing, or review of supplier records)
• Document the supply chain program and maintain records of verification activities
• Establish written procedures for receiving raw materials and other ingredients

Recall Plan Requirements

Facilities must have a written recall plan for each animal food that has an identified hazard requiring a preventive control. The recall plan must include:

• Procedures for notifying direct consignees about the recall
• Procedures for notifying the public (when appropriate)
• Procedures for conducting effectiveness checks to verify recall is carried out
• Procedures for disposing of or correcting the recalled animal food

cGMP Requirements for Animal Food

Subpart B of 21 CFR Part 507 establishes cGMP requirements specific to animal food:

• Personnel: Qualifications, training, and hygiene requirements for animal food handlers
• Plant and grounds: Facility design, maintenance, and pest control requirements
• Sanitary operations: Cleaning, sanitizing, and facility maintenance procedures
• Water supply and plumbing: Safe water supply and adequate plumbing
• Equipment and utensils: Proper design, construction, and maintenance
• Plant operations: Production and process controls, including raw material inspection and storage

How Assurentry Can Help

Assurentry provides comprehensive animal food safety compliance support:

• FDA registration: Registration for animal food facilities in FURLS
• Animal Food Safety Plan development: Written food safety plans compliant with 21 CFR 507
• Human food compliance: Parallel support for facilities that handle both human and animal food
• Inspection readiness: Preparing your animal food facility for FDA inspections