FSMA Consultant for Food Safety Modernization Act compliance
Our FSMA consultants and former auditors confirm which of the seven FSMA rules apply to you, build your Food Safety Plan and preventive controls, and get your facility ready for an FDA inspection.
- A clear read on which FSMA rules apply to your business
- A Food Safety Plan written by a Preventive Controls Qualified Individual
- Inspection readiness for every rule that reaches you
A 30-minute call with an FSMA expert. No cost and no obligation.
What is FSMA?
FSMA is the Food Safety Modernization Act, signed into law in 2011 and enforced by the FDA. It was the biggest change to US food safety law in decades, and it shifted the focus from responding to contamination after it happens to preventing it in the first place.
FSMA is not one requirement. It is a set of seven foundational rules, plus the newer Food Traceability Rule, and the ones that apply depend on what your business does. A consultant's first job is to tell you exactly which rules reach you, and then to build only what those rules require.
FSMA sits inside the FDA's wider authority. If you need the broader picture of FDA compliance such as registration and labeling, see our FDA consulting page. For the traceability rule specifically, see our FSMA 204 consulting page.
The seven foundational FSMA rules
FSMA is built on seven rules. Most businesses are covered by one or two, not all of them. Here is what each one does and who it applies to.
Preventive Controls for Human Food
A written Food Safety Plan with hazard analysis and preventive controls.
21 CFR 117
Preventive Controls for Animal Food
The same prevention approach for animal food and feed.
21 CFR 507
Produce Safety Rule
Standards for agricultural water, worker hygiene, and handling.
21 CFR 112
Foreign Supplier Verification
Importers verify foreign suppliers meet US standards.
21 CFR 1 L
Sanitary Transportation
Safe practices for moving food by truck and rail.
21 CFR 1 O
Intentional Adulteration
A food defense plan against intentional contamination.
21 CFR 121
Accredited Third-Party Certification
Recognized audits that support import programs.
Voluntary
An eighth rule, the Food Traceability Rule under FSMA 204, adds recordkeeping for foods on the Food Traceability List. We cover it in depth on our FSMA 204 page.
Which FSMA rules apply to your business?
Your role in the food chain decides your obligations. This is the starting point we confirm on the first call, including any exemptions. Many businesses fall under more than one rule, and small or qualified facilities may have reduced requirements. We map yours exactly.
| Your business | Rules that usually apply |
|---|---|
| Food manufacturer or processor | Preventive Controls, 117; Intentional Adulteration; Sanitary Transport |
| Animal food or pet food maker | Preventive Controls, 507; Sanitary Transport |
| Produce farm | Produce Safety Rule |
| Importer | Foreign Supplier Verification |
| Shipper, carrier, or receiver | Sanitary Transportation |
| Handler of foods on the Traceability List | FSMA 204 Traceability |
The Food Safety Plan and its preventive controls
For most manufacturers, the Preventive Controls rule is the heart of FSMA. It requires a written Food Safety Plan built on a hazard analysis, with preventive controls in four areas.
A Food Safety Plan starts with a hazard analysis that identifies the biological, chemical, and physical hazards in your process. Wherever a hazard needs a control, you put a preventive control in place, then monitor it, correct it when it slips, and verify it works.
The four control categories cover the ways a hazard is actually managed on a food line. We build all four where they apply, along with the recall plan the rule requires.
The PCQI requirement.Your Food Safety Plan must be prepared or overseen by a Preventive Controls Qualified Individual. We can serve as or train your PCQI so the plan holds up under FDA review.
Process controls
Cook, chill, and other steps with parameters you monitor.
Food allergen controls
Labeling and cross-contact prevention.
Sanitation controls
Cleaning and hygiene where they control a hazard.
Supply-chain controls
Verification of hazards controlled by your suppliers.
What changed, and who gets a break
Two things food businesses ask most: how FSMA changed the old approach, and whether their size earns an exemption.
Before FSMA, most food safety ran on HACCP, which focuses on a set of critical control points. FSMA introduced HARPC, Hazard Analysis and Risk-Based Preventive Controls, which is broader. It expects you to consider more hazard types, apply preventive controls beyond classic critical control points, and document a fuller Food Safety Plan. If you have a HACCP plan, we build on it rather than start over.
FSMA scales with size. Very small businesses and qualified facilities below certain sales thresholds have modified, lighter requirements, and some very small farms are exempt from parts of the Produce Safety Rule. An exemption is not automatic and still carries obligations such as attestations. We confirm your status so you neither overbuild nor miss a requirement.
Farms that grow, harvest, pack, or hold covered produce follow the Produce Safety Rule, which sets standards for agricultural water, worker training and hygiene, equipment, and domesticated and wild animals. We build the program and the records, and align it with a GAP certification if you hold one.
If you import food into the United States, FSVP requires you to verify that your foreign suppliers produce it to the same standard required of domestic makers. That means supplier evaluations, verification activities, and records, with a named FSVP importer of record. We build the program that clears your shipments at the port.
Larger facilities must have a food defense plan under the Intentional Adulteration rule. It requires a vulnerability assessment to find the steps most open to intentional contamination, mitigation strategies at those points, and monitoring and training. We build the plan and prepare your team for how the FDA assesses it.
- 7
- Foundational FSMA rules, plus the traceability rule
- 2011
- The year FSMA was officially signed into law
- 4
- Preventive control categories in a Food Safety Plan
- 30
- Minutes free consultation to get started
Support for the FSMA rules that reach you
Assess your obligations, build your Food Safety Plan, or cover multiple rules across sites. Every engagement begins with a free consultation.
FSMA Applicability Assessment
Start here. Know exactly which rules apply, and which exemptions you can claim.
- Rule-by-rule applicability review
- Qualified facility analysis
- Gap report against each rule
- Prioritized action plan
Food Safety Plan and Compliance
A PCQI-built Food Safety Plan and the programs your rules require.
- Hazard analysis and preventive controls
- Allergen, sanitation, and supply-chain programs
- Recall plan and records
- Inspection readiness
Multi-Rule and Import Program
Multi-rule. For businesses covered by several rules or importing food.
- FSVP for imported products
- Sanitary transport and food defense
- Produce Safety where it applies
- Ongoing support as rules change
Meet the lead of our FSMA team
"FSMA rewards prevention. Build the Food Safety Plan around your real hazards, keep the records honest, and an FDA inspection becomes a conversation, not a fight."
Dave Seddon, MBA, RDN, LDN, CFSO
Co-founder of FoodReady and a finalist for SQF Auditor of the Year named by the SQF Institute.
- 500+ audits
- PCQI and FSMA expertise
- FDA inspection experience
Run your Food Safety Plan, not just file it
A Food Safety Plan is only useful if it runs. FoodReady builds and maintains your hazard analysis and preventive controls, captures monitoring and verification records, and keeps supplier documentation ready for an FDA inspection. Consulting writes the plan; the software keeps it current.
- Hazard analysis builder -Preventive controls mapped to hazards.
- Monitoring records -Logs and verification captured live.
- Supplier program -Approval and verification documents.
- Inspection ready -Records retrievable in seconds.
Dashboard
What manufacturers say about working with us
"I have been building food safety programs for companies since 2009 and this process has taken anywhere from 6 months to a year, including facilities that had USDA in place to make them comply with FSMA and GFSI. I needed Eurobake to reach compliance at a faster rate."
"I would advocate for the FoodReady software for a few reasons. It helps to reduce the complexity of the implementation and tracking of the program. It provides an accessible way for management and production staff to fill out required checklists, and paperwork, and for the reviewers to approve or make note of any issues."
FSMA consulting FAQ
How can an FSMA consultant help my business prepare for FDA inspections?
An FSMA consultant provides a thorough gap assessment, develops customized HACCP and food safety plans, trains staff, and ensures that all documentation and processes comply with FSMA regulations, ensuring a successful FDA inspection.
Which FSMA rule applies to me?
It depends on your role. Manufacturers usually fall under Preventive Controls for Human Food, importers under Foreign Supplier Verification, farms under the Produce Safety Rule, and transporters under Sanitary Transportation. Many businesses are covered by more than one. We confirm your exact obligations and any exemptions on the first call.
What are the key components of an FSMA-compliant food safety plan?
An FSMA-compliant plan includes hazard analysis, preventive controls, monitoring procedures, corrective actions, verification activities, and record-keeping systems.
How does FoodReady’s software enhance FSMA compliance efforts?
FoodReady’s software offers tools for real-time monitoring, HACCP plan management, digital record-keeping, and traceability, helping businesses streamline their FSMA compliance processes and stay audit-ready.
What is the Preventive Controls Rule under FSMA, and how does it impact my business?
The Preventive Controls Rule requires facilities to implement a risk-based approach to food safety, including identifying hazards, establishing preventive measures, and maintaining proper documentation to prevent food safety issues.
How can an FSMA consultant help with supplier verification programs?
FSMA consultants assist in creating and implementing supplier verification programs to ensure that all suppliers comply with FDA standards, reducing the risk of contamination and ensuring traceability.
What are the penalties for non-compliance with FSMA, and how can consultants help avoid them?
Non-compliance with FSMA can result in FDA warnings, product recalls, fines, and facility closures. FSMA consultants ensure your processes and documentation meet FDA requirements, minimizing the risk of penalties.
Is my small business exempt from FSMA?
Possibly, in part. Very small businesses and qualified facilities below certain sales thresholds have reduced requirements, and some small farms are exempt from parts of the Produce Safety Rule. Exemptions are not automatic and still carry obligations such as attestations and records. We confirm your status so you do exactly what the rule requires.
How long does it take, and what does it cost?
An applicability assessment takes days, and a full Food Safety Plan usually takes a few weeks, depending on your process and how many rules apply. Cost depends on scope. After a free consultation we provide a clear, fixed-scope quote for your operation.
Find out which FSMA rules apply to you
Book a free consultation. We will confirm your obligations, flag any exemptions, and map the fastest path to FSMA compliance.