Develop a new HACCP plan, review an existing program, identify regulatory gaps, validate critical limits and controls, and align the documentation with the FDA food-safety framework that actually applies to your product.
Hazard Analysis and Critical Control Point (HACCP) is a preventive food-safety system that identifies and controls biological, chemical, and physical hazards. But FDA does not impose one identical HACCP rule on every food facility.
Seafood processors are subject to FDA's seafood HACCP regulation in 21 CFR Part 123. Juice processors are subject to the juice HACCP regulation in 21 CFR Part 120. Many other FDA-regulated human food facilities instead fall under Part 117's hazard analysis and risk-based preventive controls requirements, which use HACCP concepts but are not identical to a traditional HACCP system.
For many human foods, the right deliverable may be a Part 117 food safety plan with preventive controls rather than a seafood- or juice-style HACCP plan. We determine the governing framework first so the documentation is built around the correct rule.
The exact regulatory requirements differ by program, but a sound HACCP engagement starts with the product, process, hazards, controls, verification, and records.
Document the product, ingredients, processing steps, intended use, distribution, and known or reasonably foreseeable biological, chemical, and physical hazards under the applicable regulatory standard.
For HACCP-regulated operations, identify appropriate critical control points, establish critical limits, and define the monitoring procedures and frequencies needed to determine whether each CCP remains under control.
Define what happens when a deviation occurs and how the facility verifies that the HACCP system remains valid and is being implemented according to the plan.
Seafood and juice regulations assign key HACCP functions to trained or qualified individuals. Supporting sanitation, cGMP, allergen, supplier, and other prerequisite controls must also be evaluated where relevant.
Seafood, juice, dairy, and other human foods do not all follow the same federal HACCP rule.
We identify the governing food-safety framework first, then build or review the plan against the actual product and process.
Provide products, ingredients, process flow, equipment, distribution, intended use, existing plan/SOPs, testing, and relevant supporting records.
Determine the applicable FDA or other federal framework and evaluate hazards, controls, CCP logic, critical limits, and supporting evidence.
Draft the HACCP plan or revise the existing program, including monitoring, corrective actions, verification, records, and supporting procedures.
Deliver the plan, explain the control structure, identify implementation items, and outline reassessment, training, and ongoing recordkeeping needs.
The scope is tailored to the product and applicable regulation. A plan should never be copied from another facility and treated as complete.
Determine whether Seafood HACCP, Juice HACCP, Part 117 Preventive Controls, dairy HACCP, or another food-safety framework applies.
Map ingredients, receiving, storage, processing, packaging, distribution, intended use, and relevant equipment/process steps.
Identify and evaluate applicable biological, chemical, and physical hazards using the terminology required by the governing framework.
Evaluate CCPs, critical limits, preventive controls, control measures, and supporting scientific or technical justification as applicable.
Define monitoring responsibilities, frequencies, record forms, review procedures, and retention requirements within the agreed scope.
Develop or review deviation and corrective-action procedures so affected product and process control are addressed appropriately.
Review verification activities, validation support, calibration, record review, and reassessment requirements under the applicable program.
Identify missing SOPs, training, sanitation, cGMP, supplier, allergen, or prerequisite documentation needed to support the food-safety system.
These programs all use preventive food-safety concepts, but they are not interchangeable.
| Seafood HACCP | Juice HACCP | Preventive Controls | |
|---|---|---|---|
| Primary Regulation | 21 CFR Part 123 | 21 CFR Part 120 | 21 CFR Part 117 |
| Primary Scope | Fish and fishery-product processors within Part 123 | Covered juice processors within Part 120 | Many FDA-regulated human-food facilities subject to Part 117, unless exempt or modified |
| Core Written Program | Hazard analysis and HACCP plan when applicable | Written hazard analysis and HACCP plan when applicable | Written food safety plan with hazard analysis and preventive controls when applicable |
| Controls Only at CCPs? | HACCP framework uses CCPs | HACCP framework uses CCPs | No. FDA notes preventive controls can be at CCPs or at other points appropriate for food safety |
| Special Program Features | Seafood hazards, sanitation controls, trained-individual functions, annual reassessment | Juice hazards, sanitation, 5-log pathogen-reduction provisions, trained-individual functions | Preventive controls, supply-chain program, recall plan, PCQI responsibilities where applicable |
Do not use a generic HACCP template as a substitute for Part 117. FDA expressly recognizes similarities between HACCP and Preventive Controls but also states that not every provision is identical.
The right service depends on whether the facility already has usable process and hazard-control documentation.
| New Plan Development | Existing Plan Review | |
|---|---|---|
| Best For | New products, new facilities, no existing HACCP system, or major process changes | Existing HACCP plan that needs regulatory, technical, or implementation gap review |
| Starting Inputs | Product data, ingredients, process flow, equipment, distribution, intended use, supporting programs | Existing HACCP plan plus current process flow, records, SOPs, validation/support documents, and recent changes |
| Primary Work | Build hazard analysis, CCP/control structure, limits, monitoring, corrective actions, verification, and records | Test the existing plan against current operations, applicable regulation, hazard-control logic, limits, verification, and records |
| Deliverable | New written plan and supporting implementation items within scope | Revised plan and/or documented gap findings and corrections within scope |
| Inspection Guarantee | No | No |
A plan review is valuable only when the underlying process information is current. A technically polished document that does not match the actual facility operation is still a compliance risk.
The term “HACCP” is used by more than one federal food regulator, so the product category matters.
| FDA-Regulated HACCP | USDA-FSIS HACCP | |
|---|---|---|
| Common Product Areas | Seafood, juice, and FDA food programs using HACCP or HACCP-based approaches | Most meat, poultry, and certain egg-product establishments under USDA-FSIS jurisdiction |
| Primary Federal Agency | U.S. Food and Drug Administration | U.S. Department of Agriculture — Food Safety and Inspection Service |
| Same Regulation? | No | No |
| Why This Matters | FDA rules, guidance, hazards, records, and inspection expectations must fit the FDA program involved | USDA-FSIS establishments follow USDA HACCP and sanitation regulations and inspection framework |
The original product jurisdiction should be confirmed before a plan is sold as “FDA HACCP.” FDA states that USDA-FSIS has primary responsibility for meat from amenable livestock and domestic poultry, while FDA regulates other meats and food categories within its jurisdiction.
These terms help distinguish HACCP plan design from the wider preventive-controls and implementation framework.
Hazard Analysis and Critical Control Point — a preventive food-safety management system based on identifying hazards and controlling them through a structured plan.
The systematic identification and evaluation of food-safety hazards associated with the product and process under the applicable regulatory standard.
Critical Control Point — a point, step, or procedure at which control can be applied and is essential to prevent, eliminate, or reduce a food-safety hazard to an acceptable level under a HACCP system.
A maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a CCP under the applicable HACCP program.
Planned observations or measurements used to determine whether a CCP or control is operating as intended and to create a record.
Actions taken when a deviation or loss of control occurs, including disposition of affected product and correction of the cause as required by the applicable program.
Activities other than routine monitoring used to establish that the HACCP system is valid and operating according to the plan.
Scientific and technical support showing that a control measure or HACCP system, when properly implemented, can effectively control the identified hazard.
Formal review of the hazard analysis and plan to determine whether they remain adequate when conditions change and at the frequency required by the applicable regulation.
A risk-based control under Part 117 used to significantly minimize or prevent a hazard requiring a preventive control; it may be applied at or outside a traditional CCP.
Preventive Controls Qualified Individual — a person meeting Part 117's qualification standard for specified food-safety-plan functions.
Foundational practices such as sanitation, cGMPs, pest management, allergen controls, maintenance, or supplier programs that support the food-safety system.
The biggest failures are usually not formatting problems — they are regulatory-scope, hazard-analysis, implementation, or recordkeeping problems.
Treating every FDA food facility as if it is subject to the seafood or juice HACCP rule can create the wrong plan structure.
A template that does not match the actual product, ingredients, process flow, equipment, intended use, and hazards is not a reliable compliance program.
Critical limits and control parameters should have appropriate scientific, regulatory, or technical support rather than being chosen arbitrarily.
A weak hazard analysis can omit significant hazards or identify controls without documenting why they are appropriate.
FDA inspectors can compare the written program with actual operations and records. A plan that exists only on paper creates risk.
Corrective-action procedures should address both affected product and the cause of the deviation as required by the applicable framework.
Plans must be verified and reassessed at the frequencies and triggering events required by the governing regulation.
Seafood and juice HACCP regulations assign certain plan-development, modification, verification, or record-review functions to appropriately trained or qualified individuals.
These services directly support food-facility, food-import, and food-safety compliance. No unrelated drug, device, or cosmetic cross-selling.
FDA Food Facility Registration and U.S. Agent support for covered foreign food facilities.
Registration, updates, and ongoing support for covered U.S. food facilities.
Foreign Supplier Verification Program development and management for covered food importers.
Preparation and filing of Prior Notice for covered imported food shipments.
Review Nutrition Facts, allergens, ingredients, claims, and other food-label compliance risks.
FCE registration and scheduled-process filing support for covered acidified and low-acid canned foods.
Ongoing food compliance and shipment-monitoring support for FDA-regulated imports.
Explore Food Facility Registration, FSVP, Prior Notice, labeling, HACCP-related support, and other food compliance services.
Direct answers about Seafood HACCP, Juice HACCP, Preventive Controls, plan development, annual reassessment, training, CCPs, critical limits, validation, inspections, pricing, and related FDA food requirements.
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.
Tell us what you manufacture, the product category, whether you need a new plan or review, and what food-safety documentation you already have. We will confirm the likely regulatory framework and project scope.
