A HACCP plan is a written food-safety plan built around hazard analysis and control at critical points in a process. FDA's mandatory HACCP regulations apply specifically to covered seafood processors under 21 CFR Part 123 and juice processors under 21 CFR Part 120. HACCP is also used voluntarily or under other regulatory programs, so the applicable framework should be confirmed before the plan is developed.

No. FDA does not impose one universal HACCP-plan requirement on every food facility. Seafood and juice have specific HACCP regulations. Many other human-food facilities instead fall under 21 CFR Part 117's hazard analysis and risk-based preventive controls requirements, which require a written food safety plan when applicable and are similar to, but not identical with, HACCP.

FDA has specific mandatory HACCP regulations for fish and fishery products in 21 CFR Part 123 and for covered juice processing in 21 CFR Part 120. Other categories can use HACCP concepts but may be governed by different federal requirements.

Seafood processors subject to 21 CFR Part 123 must conduct a hazard analysis. When that analysis identifies one or more food-safety hazards reasonably likely to occur, the processor must have and implement a written HACCP plan meeting Part 123.

Covered juice processors must comply with 21 CFR Part 120. They must conduct a written hazard analysis for each type of juice, and when hazards are reasonably likely to occur, those hazards must be addressed through a properly designed and implemented HACCP plan. The regulation also contains the juice 5-log pathogen-reduction framework.

FDA and the National Conference on Interstate Milk Shipments maintain a Grade A voluntary HACCP alternative program. Dairy requirements should be evaluated under the applicable Grade A milk, state, federal, and facility-specific framework rather than assuming every dairy processor is subject to the seafood or juice HACCP regulations.

Most meat from amenable livestock and domestic poultry is primarily regulated by USDA-FSIS, which has its own HACCP requirements. FDA regulates many other foods and certain non-amenable meats. Jurisdiction should be confirmed before a meat or poultry project is described as FDA HACCP.

FDA states that HACCP and Preventive Controls share important concepts but are not identical. Under traditional HACCP, controls are applied at critical control points. Under Part 117, preventive controls can be applied at CCPs or at other points appropriate for food safety, and the food safety plan can include additional elements such as supply-chain controls and a recall plan when applicable.

The standard seven HACCP principles are: conduct a hazard analysis; determine critical control points; establish critical limits; establish monitoring procedures; establish corrective actions; establish verification procedures; and establish recordkeeping/documentation procedures.

No. The plan also has to meet the specific regulation that applies to the product and accurately reflect the facility's actual operations. Seafood, juice, Preventive Controls, dairy, USDA-FSIS, retail, and other programs have different requirements.

Yes. The service can include regulatory applicability review, process-flow mapping, hazard analysis, CCP/control evaluation, critical limits, monitoring, corrective actions, verification, recordkeeping, and supporting implementation items within the agreed scope.

Yes. An existing plan review can compare the written plan with current products, ingredients, processes, hazards, controls, critical limits, monitoring records, corrective actions, verification activities, reassessment history, and supporting documentation.

Typical inputs include product descriptions, ingredient lists, process flow, equipment, processing parameters, time/temperature data, packaging, intended use, distribution/storage conditions, existing SOPs, sanitation programs, testing, supplier information, scientific support for limits, and existing food-safety records. The exact list depends on the product and regulation.

A typical standard project is targeted for approximately 7–14 business days after complete product, process-flow, ingredient, equipment, and supporting documentation is received. Complex processes, missing technical support, validation work, or multiple distinct product flows can take longer.

The standard service price is $1,500 USD for the first product and $850 USD for each additional product. Complex processing, multiple distinct production flows, validation work, or expanded supporting-program review can require a tailored quote.

No. The HACCP plan development/review fee is a professional consulting fee. It is not an FDA government filing fee or payment to FDA.

A consultant-developed HACCP plan should not be represented as FDA approval or an FDA certificate. FDA may review HACCP plans and implementation during regulatory oversight, but preparation of the document does not constitute FDA approval or guarantee an inspection outcome.

Yes. FDA's seafood HACCP regulation requires the processor to reassess the adequacy of the HACCP plan whenever changes could affect the hazard analysis or plan and, at a minimum, annually.

Juice HACCP has specific validation, verification, and record-review requirements. FDA guidance explains that an appropriately trained individual validates the plan initially and at least annually thereafter, and also when process changes or other events could affect the hazard analysis or plan.

No. Reassessment, validation, verification, and review requirements depend on the governing regulation. Seafood and juice have specific HACCP provisions; Part 117 Preventive Controls has its own reanalysis and verification framework.

Under 21 CFR 123.10, certain seafood HACCP functions must be performed by an individual who has completed training in the application of HACCP principles to fish and fishery-product processing at least equivalent to the standardized curriculum recognized by FDA, or who is otherwise qualified through job experience.

Under 21 CFR 120.13, certain juice HACCP functions must be performed by a person who has completed training in applying HACCP principles to juice processing at least equivalent to the standardized curriculum recognized by FDA, or who is otherwise qualified through job experience.

No. FDA's juice guidance specifically notes that the appropriately trained person may be an employee or a hired outside expert. Seafood requirements likewise focus on the qualifications of the person performing specified HACCP functions.

A critical control point, or CCP, is a point, step, or procedure where control can be applied and is essential to prevent, eliminate, or reduce a food-safety hazard to an acceptable level under the applicable HACCP framework.

A critical limit is the maximum or minimum value to which a parameter must be controlled at a CCP to prevent, eliminate, or reduce a hazard to an acceptable level. The limit should be supported by appropriate scientific, regulatory, or technical information.

Validation is the scientific and technical support showing that the HACCP system or control measure, when properly implemented, can effectively control the identified hazard. The required validation approach depends on the applicable regulation and control.

Verification consists of activities other than routine monitoring that establish whether the HACCP plan is valid and whether the system is operating according to the plan. Verification can include record review, calibration, reassessment, and other activities specified by the applicable rule.

Prerequisite programs are foundational controls that support the food-safety system, such as cGMPs, sanitation, pest management, maintenance, allergen management, training, and supplier programs. Which programs are required and how they interact with the plan depend on the regulatory framework.

Sometimes products with genuinely similar hazards, processing steps, controls, and regulatory requirements can be grouped efficiently, but a plan should not combine products in a way that hides meaningful differences. Juice regulations, for example, allow grouping of juice types in a hazard analysis only when hazards and control measures are identical.

The hazard analysis and plan should be reviewed to determine whether the new product, ingredient, supplier, equipment, processing parameter, packaging, distribution method, intended use, or other change affects hazards or controls. The applicable regulation determines the exact reassessment or reanalysis requirement.

FDA can review the hazard analysis, HACCP plan, implementation, monitoring records, corrective actions, verification activities, sanitation controls, training/qualification records, and other required records. The details depend on whether the facility is subject to Part 123, Part 120, or another program.

No. HACCP is an implemented food-safety system, not just a document. Monitoring, corrective actions, verification, recordkeeping, sanitation, training, and actual process controls must operate consistently with the written plan.

Yes, the engagement can include review of the technical basis supplied for critical limits and control parameters. If specialized validation studies, process-authority work, challenge studies, laboratory testing, or engineering analysis are needed, those may require separate qualified specialists or scope.

No. HACCP or a food safety plan addresses food-safety controls. Food Facility Registration, FSVP, Prior Notice, labeling, FCE/SID, and other FDA requirements are separate programs that may also apply.

Yes. FDA's seafood and juice HACCP requirements apply to covered imported products and foreign processors within their scope. Other foreign food facilities may instead be subject to Part 117 Preventive Controls or other requirements, depending on the product and activity.

Yes. Parts 123 and 120 contain importer-related requirements for seafood and juice. Those program-specific importer obligations are distinct from the general FSVP framework and should be evaluated separately.