- Food Safety Modernization Act (FSMA)
- Preventive Controls for Animal Food Rule
FSMA: Preventive Controls for Animal Food Rule
The Preventive Controls for Animal Food Rule aims to ensure safe animal food by requiring manufacturers to adopt Current Good Manufacturing Practices (CGMP) and by codifying the seven steps of the Hazard Analysis and Critical Control Points (HACCP) framework in their process.
Key requirements
The rule establishes adapted CGMPs to accommodate various animal food operations, providing flexible, streamlined requirements. It requires the creation and implementation of a written food safety plan that includes:
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It also mandates that manufacturers implement a risk-based supply chain program if sourcing raw ingredients from suppliers. If the hazard analysis identifies risks that are not controlled in their own facility, then manufacturers are responsible for only receiving ingredients from approved suppliers that have verification of preventive controls. If relying on other entities to verify suppliers' preventive controls, manufacturers must review and assess the documentation.
The Preventive Controls for Animal Food Rule is part of the Food Safety Modernization Act (FSMA) and enforced by the U.S. Food and Drug Administration (FDA).
How the Rule achieves its goal
The Rule standardizes animal food production regulations through a preventive, science-based approach. Like produce safety and human food rules, it creates transparency and mitigates risks across diverse product categories.
Who must comply
Manufacturers and processors of food for animals must comply with the Preventive Controls for Animal Food Rule. Facilities that only hold byproducts for animal food and have implemented controls for human food are exempt. Feed mill operations vertically integrated into farming operations are also exempt, but the FDA has indicated that a future rule may require some to comply with the cGMP established in this rule.
Noncompliance consequences
Non-compliant facilities face penalties ranging from fines and increased inspections to legal action and registration suspension. Suspension bars US food sales until the FDA confirms compliance. Noncompliance also risks recalls, damaging reputation, and market share.
How can food manufacturers comply with Preventive Controls for Animal Food?
Implementing an effective food safety plan requires reliable monitoring across all production processes.
Food Safety Plans: Solutions for process control
ifm sanitary process instruments with IO-Link technology automate data collection across food and beverage manufacturing processes for simplifying compliance. Temperature monitoring is vital for animal food processing, particularly pet food. With real-time data, manufacturers immediately detect changes in their processes and can intervene to mitigate risks.
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ifm smart temperature sensors ensure manufacturers maintain consistent temperatures on mixers, extruders, drying ovens, and cooling conveyors used during animal food production.
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Smart flow and pressure sensors on mixers with real-time monitoring via IO-Link communication prevent over-pressurization and maintain proper airflow across cooling trays or conveyors.
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Connected level sensors verify product levels in drying trays to avoid overloading food and incomplete processing steps.
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Field-mountable IO-Link masters connect real-time data from flow, temperature, level, and conductivity sensors to PLCs for improved machine control and higher-level software systems via the IIoT port for advanced analysis. The ifm moneo Track & Trace software platform provides digital traceability of key data points during batch production.
Preventive Controls oversight: management and verification
Manufacturers must monitor and verify preventive controls. The ifm TCC temperature sensor provides continuous oversight and verification of calibration between manual checks. Dual temperature sensing elements and onboard diagnostics alert users to sensor drift, proactively alerting the facility and enhancing protection between timed calibrations. With an additional layer of oversight, manufacturers increase confidence in their temperature measurements and food safety.
Reason for the Rule
Before FSMA, FDA inspections under the FD&C Act focused only on adulteration and misbranding. State-level regulations of animal food production were inconsistent, and many safety guidelines were non-binding.
History
FSMA became law in 2011. The FDA published the final Preventive Controls for Animal Food Rule in 2015 and implemented a staggered timeline for businesses of varying sizes.
Timeline
- September 2015: Final Rule is published.
- September 2016: Large animal food facilities must comply with CGMP requirements.
- September 2017: Large animal food facilities must comply with preventive controls. Small facilities must implement CGMP requirements.
- September 2018: Small facilities must comply with preventive controls requirements.
In the news
- FDA asks pet food manufacturers to adhere to safety plans in the wake of H5N1 (January 2025)
- Another wild cat succumbs to bird flu at local shelter as FDA issues precautions on cat food (January 2025)
- FDA Now Requires Raw Pet Food Manufacturers to Consider HPAI in Food Safety Plans (January 2025)
- Salmonella outbreak tied to pet food spurs FDA warning letter over facility failures (December 2024)
- Primal Pet Foods—A Cautionary Tale (February 2024)
