Preventive controls for human food are FDA's core FSMA requirements at 21 CFR Part 117: current good manufacturing practices for every covered facility, plus a written, hazard-based food safety plan for facilities that are not exempt. It is the frame most other food safety work in a plant hangs on.

The Food Safety Modernization Act reset the goal of food regulation from responding to outbreaks to preventing them, and Part 117 is where that shift became a rule for human-food manufacturers. It updated the old good manufacturing practices and bolted on a modern, HACCP-derived preventive controls system. This post covers who must comply, the CGMP foundation, the hazard analysis at the center, the four families of preventive controls, and what a food safety plan is and who has to write it.

What are preventive controls for human food?

Preventive controls for human food are a two-part system. Part one is the current good manufacturing practices of Subpart B: the baseline sanitary requirements for personnel, plant and grounds, sanitation, equipment, and process controls that every covered facility follows. Part two is hazard analysis and risk-based preventive controls in Subpart C: a written food safety plan in which a facility analyzes hazards, applies controls to significantly minimize or prevent the ones reasonably likely to occur, and verifies those controls work. A supply-chain program in Subpart G covers hazards a supplier controls.

"Preventive controls" is the rule's term for the risk-based procedures a knowledgeable person would use to significantly minimize or prevent identified hazards, consistent with current food safety science. The philosophy is design safety in, then prove it: control the hazard at the right step, monitor the control, correct deviations, verify, and document. It is HACCP's logic broadened to include supply chain, allergens, and sanitation as first-class controls.

Anatomy of a Part 117 food safety plan The food safety plan: hazard analysis drives the controls hazard analysis what is reasonably likely? Process cook, chill, pH, aw Food allergen label & cross-contact Sanitation pathogens, carryover Supply-chain supplier-controlled each control: monitoring · corrective actions · verification · records recall plan
A Part 117 food safety plan: the hazard analysis routes each identified hazard to a control family, and every applied control carries monitoring, corrective actions, verification, and records. A recall plan sits alongside.

Who must comply with Part 117?

Part 117 applies to facilities required to register with FDA as food facilities, most businesses that manufacture, process, pack, or hold human food in the US or for the US market. The CGMPs of Subpart B apply broadly. The preventive controls requirements of Subpart C apply to those covered facilities unless an exemption fits. The exemptions, listed in 21 CFR 117.5 include activities already covered by the seafood (Part 123) or juice (Part 120) HACCP rules, certain low-risk on-farm activities, dietary supplements under their own CGMPs, and others.

A key middle category is the qualified facility very small businesses, or those selling mostly to local consumers and retailers below a dollar threshold, which is exempt from full preventive controls and instead meets modified requirements: attesting to hazard-based controls or compliance with applicable non-federal food safety law. Compliance dates were staggered by size after the 2015 final rule, with larger businesses first and smaller ones following in later years. The safe path is to check status against 117.5 rather than assume; misjudging exemption is a common and expensive mistake, because a facility that wrongly claims an exemption is operating without a food safety plan it was legally required to have. The framework connects directly to broader GMP compliance and any HACCP-based system.

Who must comply with Part 117 Who Part 117 covers, and who is filtered out ALL FDA-registered food facilities → CGMPs (Subpart B) apply minus exemptions (117.5) & qualified-facility modified rules covered facilities: full PC plan seafood/juice HACCP, on-farm, supplements qualified facilities → modified requirements
Everyone registered follows the CGMPs; exemptions and qualified-facility status narrow who must build a full preventive controls plan. Check status against 117.5 before assuming you are out.

What is in the CGMPs?

Subpart B modernized the old Part 110 good manufacturing practices and is the floor every covered facility stands on. It covers personnel and hygiene, plant and grounds, sanitary operations and facilities, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels. Two changes FSMA made stand out: it wrote allergen cross-contact into the CGMPs explicitly, and it made certain education-and-training and management-oversight expectations firmer.

These CGMPs are where day-to-day programs live, personnel hygiene sanitation and SSOPs pest control, and equipment maintenance. They function as prerequisite programs beneath the food safety plan: strong CGMPs shrink the number of hazards that reach the level of needing a preventive control. Weak CGMPs push more risk up into the plan, where it is costlier to manage. It is worth noting what changed and what did not. The core sanitary expectations carried over from the old Part 110 largely intact, so a plant with a mature GMP program was not starting from zero. What FSMA added was the requirement to think in terms of hazards and controls on top of that foundation, and to make allergen cross-contact an explicit CGMP concern rather than an afterthought. A plant that treats its CGMPs as living prerequisite programs, audited and recorded, gives the food safety plan far less to carry.

What is the hazard analysis?

The hazard analysis is the engine of the whole plan, and everything else follows from it. A facility identifies the known or reasonably foreseeable hazards, biological, chemical (including radiological and allergens), and physical, for each type of food it makes, considering ingredients, process steps, the plant environment, and even the possibility of economically motivated adulteration. For each hazard it evaluates severity and probability to decide whether the hazard requires a preventive control.

The phrase "reasonably likely to occur" does a lot of work: it is the filter that separates hazards needing a control from those adequately handled by prerequisite programs. Get the analysis right and the rest of the plan is largely bookkeeping; get it wrong, a real hazard dismissed, or parked in the wrong control layer, and you have a gap that an auditor, or an outbreak, eventually finds. Because the analysis demands food safety judgment, the rule requires it be done by a qualified person.

What preventive controls are required?

Where the hazard analysis identifies a hazard requiring a control, the facility applies one from the appropriate family:

Every applied control is wrapped in management components, monitoring that it is operating, corrective actions when it is not, and verification that it is effective (validation, calibration, records review, and product or environmental testing as appropriate), all documented. The facility also maintains a written recall plan for any hazard requiring a preventive control. Verification of sanitation controls is often where an environmental monitoring program plugs in.

What is a food safety plan and who writes it?

The food safety plan is the written document that ties it all together: the hazard analysis, the preventive controls, and the procedures for monitoring, corrective actions, verification, the supply-chain program, and the recall plan. It is the artifact an FDA investigator asks for first, and the reference the plant runs against every day.

The rule requires that the plan be prepared, or its preparation overseen, by a preventive controls qualified individual (PCQI) someone who has successfully completed training equivalent to the standardized FSPCA curriculum, or is otherwise qualified through job experience. The PCQI also oversees validation of process controls, records review, and reanalysis of the plan. The role is covered in depth in PCQI. Building the plan is a defined sequence:

  1. Assemble the team and a PCQI. Put a qualified individual in charge and gather people who know the products and processes.
  2. Describe the product and process. Document ingredients, process flow, packaging, distribution, and intended use for each food.
  3. Conduct the hazard analysis. Identify biological, chemical, and physical hazards and evaluate which require a preventive control.
  4. Assign preventive controls. Route each hazard requiring a control to a process, allergen, sanitation, or supply-chain control with parameters or limits.
  5. Define management components. Set monitoring, corrective actions, and verification for each control, and write the recall plan.
  6. Validate and implement. Validate process controls, train staff, and put the plan into operation with its records.
  7. Reanalyze on change or every 3 years. Revisit the whole plan when products, processes, or new hazard information change it, and at least every three years.

The numbers worth pinning

Part 117's structure and obligations come straight from the rule, cite it, not the summary:

A food safety plan is only as good as the records proving its controls ran, monitoring logs, corrective actions, verification, and supplier documents. Paper systems make those easy to skip and slow to retrieve, which is why so much audit week goes to reconstructing binders. Capturing checks at the point of work flags a missed monitoring reading in real time and turns audit prep into a query, the digitize-the-paper move Harmony runs for production and quality logs (see how CLS did it). It ties Part 117 to FSMA 204 traceability physical-hazard control in physical hazards in food and its sibling rule, preventive controls for animal food.