Looking for information on FSMA PCQI 2.0? Click here to view our FAQs on the latest updates.

Q - What is FSMA? (Food Safety Modernization Act)

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 Guidance

Q - What is the FSMA Preventive Controls for Human Food (PCHF) rule and does it apply to my facility?

A - The Preventive Controls for Human Food Rule, has been called “HACCP on steroids” by many industry insiders. What they mean is that while the rule uses HACCP principles to identify hazards and control them in your process, 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.

Q - What is a PCQI (Preventive Controls Qualified Individual) and what are responsibilities?

A - 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)

Q - How does someone become a PCQI (Preventive Controls Qualified Individual)? and What training is needed?

A - A company appoints the facility's PCQI, similar to 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 - according to the FDA Preventive Controls for Human Food Rule, a PCQI is a qualified individual who has successfully completed the 20-hour training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.

Q - How do I get “certified” to HACCP or PCQI (Preventive Controls for Human Food)?

A - Attending a Preventive Controls for Human Food (PCQI) 20-hour course does not grant “certification” to the attendee. A “Certificate” of Attendance (or Completion) is presented to attendees for completing the course. The Food Safety Preventive Controls Alliance (FSPCA), developer of the PCHF training materials, specifically says that they are not “certifying” anyone, including the Trainers. Any firm that advertises FSMA or PCQI “Certification” is misleading. However, having the ability to show an auditor or inspector your issued Certificate of Attendance for the PCHF course will satisfy the training requirements for the Preventive Controls Qualified Individual under the rule.

Q - How are the Preventive Controls rules different from the Hazard Analysis and Critical Control Points (HACCP) system?

A - 

Q -What are the Key Requirements for the Preventive Controls for Human Foods Rule?

A - 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 that includes:

• 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.

Q- What firms are exempt from the Preventive Controls Rule (Subpart C)

• 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 (RAC) 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.

Q- Are dietary supplements included in the Preventive Controls Rule?

A - Dietary supplements are exempted in the Preventive Controls for Human Foods Rule. However dietary ingredients would be addressed by the Rule. See FDA guidance here

Q - What are FSMA training requirements for personnel other than the PCQI?

A - Previously non-binding provisions, such as education and training, are now binding–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.)

Q – How are Distributors with cold storage covered under FSMA?

A - 1) Foreign Supplier Verification Rule Program (FSVP) if importing. o Am I subject to the? See here FSVP rule Key Requirements – see here

2) Preventive Controls Rule with modified requirements and GMPs. TITLE 21--CHAPTER I--FOOD AND DRUG ADMINISTRATION 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 Link

3) Sanitary Transport Rule Q – How are food packaging materials covered under FSMA? A -Food packaging materials wouldn't fall under the Preventive Controls rule which only applies to registered food facilities. If any materials are imported, the company would be subject to the Foreign Supplier Verification rule. There is a need to follow GMPs to ensure packaging is not contaminated and is produced under sanitary conditions. It may be helpful to packaging companies to familiarize themselves with the PC rule to appease customers.

Q - How is fruit and vegetable packing covered under FSMA: Preventive Controls or Produce Safety Rule?

A - 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

For their 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).

Details and related requirements are reviewed in the class HACCP for Produce Operations

If your 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 – need to do a hazard analysis for what comes into your 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.