Preventive Controls for Animal Food: The Rule
Subpart A: General Provisions
Subpart A discusses who must comply and provides some definitions of the language used throughout the rule.
Who Must Comply?
Facilities that manufacture, process, pack, or hold animal food for consumption in the United States. In general, those that register under the Bioterrorism Act of 2002. Animal food covered by specific CGMP regulations must still comply with those regulations (Low-acid canned food, Medicated feed).
What is a farm?
Feed mills that are part of a farm are exempt from registering as a food facility and are not subject to the rule. For a feed mill to be part of a farm, the animals and feed mill are under the same management in one general location, AND the animal food made at the mill is only fed to animals under the farm’s management.
What is the difference between a Qualified Individual and a Preventive Controls Qualified Individual?
A qualified individual is a person who has the education, training, or experience (or combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
All individuals who manufacture/process/pack/hold animal food must be qualified to perform their assigned duties. This includes temporary and seasonal workers. They must have the education, training, experience, or a combination thereof, to complete duties in a way that results in safe food. They must also receive training on animal food hygiene and safety, including importance of employee health and personnel hygiene as appropriate.
Preventive Controls Qualified Individual (PCQI)
A Preventive Controls Qualified Individual (PCQI) is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that recognized under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system.
The PCQI must oversee:
1. Preparation of the food safety plan
2. Validation of the preventive controls
3. Determination that validation is not required
4. Review of Records
5. Reanalysis of the food safety plan
6. Written justification for validation to be performed in a timeframe that exceeds the first 90 days of production
7. Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days
8. Determination that reanalysis can be completed and additional preventive controls validated as appropriate to the nature of the preventive control and its role in the facility’s food safety system, in a timeframe that exceeds the first 90 calendar days of production.
Subpart B: Current Good Manufacturing Practice
Current Good Manufacturing Practice (CGMP) is considered by the FDA to be “necessary to prevent animal food from containing filthy, putrid, or decomposed substances, being otherwise unfit for food, or being prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health” (Preambe, II: Legal Authority).
The CGMP establishes baseline standards for the production of safe animal food and the creation of a successful Food Safety Plan. The components of CGMP, as set forth by the rule are:
- Plant and grounds
- Water supply and plumbing
- Equipment and utensils
- Plant operations
- Holding and distribution
- Holding and distribution of human food by-products for use as animal food
Subpart C: Hazard Analysis and Risk-Based Preventive Controls
What is a Hazard?
A hazard, as defined by the FDA, is any biological, chemical (including radiological) or physical agent that has the potential to cause illness or injury in humans or animals. Similarly, a known or reasonably foreseeable hazard is a biological, chemical (including radiological) or physical hazard that is known to be, or has the potential to be, associated with the facility or the animal food.
A hazard requiring a preventive control is a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in an animal food and components to manage those controls (such as monitoring, corrections, or corrective actions, verification, and records) as appropriate to the animal food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
What are Preventive Controls?
Preventive controls are those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, of holding of animal food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.
Some example hazards in animal food include:
- Biological Hazards (Salmonella spp., Listeria monocytogenes)
- Chemical Hazards (Mycotoxins, Pesticides and process-related or industrial chemicals, drug carryover, nutrient deficiencies or toxicities)
- Physical Hazards (Stones, Glass, Metal)
Food Safety Plans
The Food Safety Plan must be written or signed off on by a PCQI, who is qualified through training or job experience. The plan should contain:
- Background Information (optional)
- Hazard Analysis
- Preventive Controls (as required)
- Supply-Chain Program (as required)
- Recall Plan (as required)
- Monitoring & Implementation Procedures (as required)
- Corrective Action Procedures (as required)
- Verification Procedures (as required)
A written food safety plan is required to include the hazard analysis and implementation records. If the hazard analysis determines there is a hazard requiring a preventive control, the food safety plan must also include preventive controls and their management components and a recall plan. The format is flexible to meet the needs of the facility. The food safety plan must be reanalyzed at least every 3 years or more frequently, as appropriate.
It is also important to note that the hazard analysis is not one-size-fits-all. There are going to be differences in known or reasonably foreseeable based on the species, production class, and how the animals are fed. There will also be differences in preventive controls determinations, as different PCQI will determine different severity, probability, and prerequisite programs and CGMP activities per facility and based on their experiences.
There are some items that must be considered in the hazard analysis:
- Formulation of the animal food
- Condition, function, and design of facility and equipment
- Raw materials and other ingredients
- Transportation practices
- Manufacturing/processing procedures
- Packaging and labeling activities
- Storage and distribution
- Intended or reasonably foreseeable use
- Sanitation, including employee hygiene
- Other relevant factors, such as temporal (weather-related) nature of some hazards
Types of Controls
There are four different types of controls: process controls, sanitation controls, supply-chain applied controls, and other controls. Process preventive controls utilize procedures, practices, and processes to either significantly minimize or prevent a hazard in animal food. This allows the facility to establish specific parameters that must be met in order to assure that animal food safety is protected and provides for evidence-based protection of animal food. Sanitation preventive controls are most appropriate to controls environmental pathogens when finished product is exposed to the environment prior to packaging or when pathogens are transferred through cross-contamination. Preventive controls are subject to preventive control management components to ensure the effectiveness of the preventive controls, such as monitoring, corrective actions and corrections, and verification (including validation).
Recall plans are also a requirement of the food safety plan if there are any hazards requiring preventive controls identified in the hazard analysis. The plan must be written and describe steps to take and assign responsibility to notify directly customers and consignees, notify the public, when appropriate, conduct effectiveness checks, and execute disposition of the food.
Subpart E: Supply-Chain Program
A receiving facility must establish and implement a risk-based supply-chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply-chain applied control. This program is appropriate when hazards are controlled prior to receipt by the receiving facility that manufactures/processes the animal food. It establishes specific requirements that the receiving facility must have in place in order to assure that a supplier program is sufficient to protect animal food safety.
Subpart F: Records
Records must be kept as original records, true copies, or electronic records, can contain actual values and observations, must be accurate, indelible, and legible, must be created concurrently with performance of the activity, and must be as detailed as possible. Records must include information adequate to identify the plant or facility (name and location), the date, and when appropriate, time of the activity, signature or initials of the person performing the activity, and the identity of the product and lot code, if any, when appropriate. These records are exempt from 21 CFR 11 requirements.