FSMA & Preventive Controls for Human Food (PCHF) Q&A

The Food Safety Modernization Act is the most sweeping reform of U.S. food safety laws in more than 70 years and was signed into law by President Obama in 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.  - Link to FDA/FSMA Rules & Guidance

 The Preventive Controls for Human Food Rule uses HACCP principles to identify hazards and control them in your process, AND it incorporates controls beyond those within the HACCP framework. If your facility is required to register with FDA under section 415 of the FD & C Act, then your facility is likely covered under this rule. However, there are exceptions. The regulation requires that certain activities be performed by a Preventive Controls Qualified Individual (PCQI) who is knowledgeable in the development and application of risk-based preventive controls. 

According to the definitions in the FDA Preventive Controls for Human Food Rule, a PCQI is a qualified individual (QI) who is knowledgeable in the development and application of risk-based preventive controls either through job experience or by receiving a training under a standardized curriculum recognized as adequate by FDA. The PCQI is qualified to develop and apply a food safety system. The responsibilities of a PCQI include the following activities, according to section 117.180 of the Rule: 

• Develop or oversee preparation of the food safety plan - 117.126(a)(2) 

• Validation of the preventive controls - 117.160(b)(1) 

• Review records - 117.165(a)(4) 

• Reanalysis of the food safety plan - 117.170(d) 

 • A company appoints the facility's PCQI, which is like appointing someone to be a manager.  At least one PC “qualified individual” is required at each facility if the company is under the Preventive Controls for Human or Animal Food Rule.   

• Training - a PCQI must be  qualified in the development and application of risk-based preventive controls at least equivalent to a standardized curriculum recognized as adequate by the FDA/FSPCA.  Or, they may be "otherwise qualified through job experience (they don't specify) to develop and apply a food safety system. This training is the only training recognized by the FDA so inspectors and auditors will look for FSPCA certificates.   

•    FSPCA is the FDA organization which oversees training for FSMA courses only delivered by Lead Instructors (like Ingrid Penuela) and Certificates are FSPCA issued.  

For all employees in a PCHF regulated company - Individuals must be trained in the principles of food hygiene and food safety as appropriate to the food, the facility, and the individual’s assigned duties. All employees must be trained in food safety and food hygiene (GMPs, GDPs, GAPs, etc.) 

According to the definitions in the FDA Preventive Controls for Human Food Rule, a PCQI is a qualified individual (QI) who is knowledgeable in the development and application of risk-based preventive controls either through job experience or by receiving a training under a standardized curriculum recognized as adequate by FDA. The PCQI is qualified to develop and apply a food safety system. The responsibilities of a PCQI include the following activities, according to section 117.180 of the Rule:  • Develop or oversee preparation of the food safety plan - 117.126(a)(2)  • Validation of the preventive controls - 117.160(b)(1)  • Review records - 117.165(a)(4)  • Reanalysis of the food safety plan - 117.170(d) 

Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk‐based preventive controls. The rule sets requirements for a written food safety plan including: 

• Hazard analysis: Hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. 

• Preventive controls: These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. In addition to having a Recall Plan in place, preventive controls must be in place for the following: 1. Process controls 2. Allergen controls 3. Sanitation control 4. Supply‐chain controls 

• Oversight and management of preventive controls: The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and can correct problems that may arise. 

•  Monitoring: Monitoring is conducted as appropriate to the preventive control. 

• Corrective actions and corrections: Corrections are steps taken to timely identify and correct a minor, isolated problem that occurs during food production. Corrective actions include actions to identify a problem with preventive control implementation, to reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent it from entering commerce. Corrective actions must be documented with records. 

•  Verification: As with traditional HACCP these activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard; calibration (or accuracy checks) of process monitoring equipment and verification instruments and reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Product testing and environmental monitoring are possible verification activities but are only required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring generally would be required if contamination of a ready‐to‐eat food with an environmental pathogen is a hazard requiring a preventive control. 

• Facilities operating under Juice and Seafood HACCP programs* 

• Activities within the definition of a “farm” (Produce Safety Rule may apply) 

• Low acid canned foods* 

• Alcoholic beverage processing 

• Dietary supplement manufacture, processing or holding 

• Storing raw agricultural commodities such as wheat, soybeans to be used in food 

• manufacturing, other than fruits and vegetables 

• Storing unexposed packaged food at ambient temperatures 

• “Qualified” facilities** 

• Business with average annual sales of <$500,000 per year during that last three years, and sales to consumers or local retailers or restaurants (within the same state or within 275 miles) must exceed sales to others, OR Very small (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3‐year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed or held without sale. 

        *Foods regulated by USDA, (meat, poultry and egg products) are not covered. Facilities regulated under HACCP (Juice and Seafood) and Low Acid Foods are required to comply with 21 CFR 117 Subpart B – Good Manufacturing Practices 

      **Qualified facilities may be eligible for an exemption from the hazard analysis, risk based preventive controls requirements (Subpart “C” of the rule) and supply‐chain preventive control requirements (Subpart “G”). Qualified facilities must register and submit documentation to FDA to verify their status. They must comply with cGMPs and other parts of the rule. 

1) Foreign Supplier Verification Rule Program (FSVP) if importing.   

Am I subject to it  See here  FSVP rule Key Requirements – see here   

2) Preventive Controls Rule with modified requirements and GMPs.   

TITLE 21--CHAPTER I--FDA SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD Subpart D--Modified Requirements - see here

3) Sanitary Transport Rule   

Preventive Controls or Produce Safety Rule?  

Packing fresh fruit and vegetables does not fall under the Preventive Controls Rule – it is subject to the Produce Safety Rule (GMP and, if importing, FSVP are relevant trainings). 

Example: a contracted citrus packing company will require  Supplier Compliance - they would ask their clients to provide proof that they are in compliance with GAPs under the Produce Safety Rule.   This could be accomplished by their showing a certificate (FDA, GLOBALG.A.P., Primus) or a Letter of Continuing Guarantee (LOCG).  

If a packing business falls under the FSMA Produce Safety Rule, it likely fits* into the secondary activities farm category as defined below and requires a risk-assessment and  needs to do a hazard analysis (for what comes into the facility).  

Produce Safety Rule -   (2) Secondary Activities Farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in paragraphs (1)(ii) and (iii) of this definition.  

Packing means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. 

* Please keep in mind this may not hold true for all companies who pack. It depends on multiple factors like ownership, physical location of packing in relation to the farm, whether they pack their own fruit versus fruit owned/provided by other entities.