- Food Safety Modernization Act (FSMA)
- Preventive Controls for Human Foods Rule
FSMA: Preventive Controls for Human Foods (PCHF) Rule
The Preventive Controls for Human Foods (PCHF) Rule ensures food manufacturers prioritize safety by making previously optional Current Good Manufacturing Practices (CGMP) provisions mandatory and requiring manufacturers to have written safety plans.
The PCHF is part of the Food Safety Modernization Act (FSMA). It is enforced by the U.S. Food and Drug Administration (FDA). A similair rule exists for animal food.
Food safety plans
Food manufacturers must identify risks, develop and formalize risk mitigation plans, and verify the plans function as intended. Plans must be:
- Developed by a Preventive Controls Qualified Individual (PCQI)
- Unique to each facility based on their equipment, technologies, and materials
- Reanalyzed at least once every three years.
Requiring written plans for every manufacturing location and consistently revisiting those plans helps build a culture of food safety within food and beverage manufacturing facilities.
CCGMP updates
CCGMP guidance for required worker training, allergen cross-contact prevention, and oversight of human food by-products used for animal food are now mandatory:
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Employees who manufacture, process, pack, or hold food receive training on food safety plan elements relevant to their job responsibilities.
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Food facilities must reduce the risk of allergen contamination and unintentional cross-contact by identifying potential hazards and developing food safety protocols (The Rule does not specify exact protocols or require dedicated separate production lines).
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Human food by-products intended for animal food must maintain adequate sanitation during storage and distribution to prevent contamination
How the Rule achieves its goal
The Rule codifies the 7-step Hazard Analysis and Critical Control Points (HACCP) framework, requiring a proactive,science-based approach to food safety. Food facilities must consider where vulnerabilities exist and take proper measures to mitigate the risks. Food facilities must:
- Conduct hazard analysis
- Establish preventive controls
- Manage preventive controls
- Establish a relevant supply chain program
- Maintain recall plans
The Hazard Analysis should lead to specific Preventive Controls to mitigate identified hazards.
Supply chain program
Facilities must establish supply-chain programs when hazard analysis identifies supply chain risks. These programs require implementing preventive controls and verifying supplier compliance with protocols.
Manufacturers retain responsibility for reviewing documentation and verifying supplier controls, even when relying on third-party organizations to provide preventive control verification.
Who must comply
The Rule applies to domestic and foreign food facilities required to register under section 415 of the Food, Drug, & Cosmetic Act, with exemptions for food regulated elsewhere:
- Dietary supplements
- Seafood
- Juice
- Low-acid canned foods (microbiological hazards only)
- Alcoholic beverages
- Small and very small farm businesses covered by the Produce Rule
Modified requirements exist for:
- Warehouses storing only unexposed packaged food
- Grain elevators and warehouses only storing raw commodities for further processing or distribution
Noncompliance
The FDA can impose financial penalties, increase inspections and oversight, take legal action, and enact registration suspension, preventing a facility from legally selling food products in the US. Noncompliance also risks product recalls, reputational damage, and market share loss.
How can food facilities comply with PCFH?
Achieving PCFH compliance demands robust monitoring systems and verifiable data collection across all production processes.
Food Safety Plan solutions
ifm offers robust sanitary process instruments with embedded IO-Link technology to help food producers automate process data collection and catch potential production risks in real time.
Process controls
ifm’s machine library delivers innovative technologies for enhanced performance and reliability throughout food and beverage production:
- Smart flow and pressure sensors provide real-time monitoring via IO-Link
- moneo Cloud software provides digital traceability of key data points across higher-level software systems
Sanitation controls
Real-time monitoring of clean-in-place (CIP) skids provides manufacturers with continuous data that confirms machinery cleanliness instead of relying on time-based processes. IO-Link technology collects more accurate real-time data from flow, temperature, level, and conductivity sensors.
All-in-one oversight, management, and verification of Preventive Controls
- The ifm TCC series temperature sensor provides continuous, real-time temperature process values and time-stamped temperature data with embedded monitoring and verification through IO-Link digital signals.
- Dual sensing measurements and onboard diagnostic algorithms alert producers to sensor drift. These features provide an additional layer of protection between timed calibrations of temperature instruments by recording anomalies that may have previously gone undetected.
- Farm animal traceability: RFID tags on dairy cows (when did it eat, when and where it is milked, washed down before milking, walk into their stalls and tag is read, robot milks them, and then at the end the cow leaves and it’s read again. In the milker, temperature, weight, etc. is recorded to understand the health of the cow.)
History of the Rule
The Preventive Controls for Human Food rule was established under the 2011 Food Safety Modernization Act (FSMA). After being published in 2015, the FDA rolled out compliance to various company sizes from 2016 to 2018. It provided additional guidance in the early 2020s.
Timeline
- September 2011: The Food Safety Preventive Controls Alliance, a public-private alliance, is established to provide training for food facilities.
- September 2016: Large food companies are required to comply.
- September 2017: Small food companies are required to comply. Inspections begin with the goal of education before enforcement.
- September 2018: Very small food companies and those subject to the Pasteurized Milk Ordinance (PMO) are required to comply.
- May 2023: The FDA publishes new draft guidance regarding allergen cross-contact.
- January 2024: The FDA publishes new draft guidance regarding part 117 (preventive controls).