Overview of the Seven FSMA Rules

The FDA Food Safety Modernization Act (FSMA) regulations are the most comprehensive overhaul of the FDA food safety regulations in over 70 years. They were approved in 2011, and the effective dates began in 2015, as the rules were finalized and published.

FSMA is broken into 7 different rules, with the intent to protect the U.S. food supply during all points of the supply and distribution chains. Each rule covers a specific part of domestic food production, processing and transportation of human and animal food, as well as the importation of food for humans and animals, and strategies to mitigate intentional adulteration.

The FSMA Rules are a science-and risk-based approach to the management of food safety. This is a major shift instead reacting to an outbreak after it happens.

Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), which covers fruits, vegetables and tree nuts that are likely to be consumed raw.

• This is the first time the produce industry has been regulated at the farm level. The USDA Good Agricultural Practices (GAPs) are voluntary recommendations, and offers a certification upon request. Certification is driven by market demand.

• Focuses on activities associated with the five identified routes of contamination: agricultural water, domestic and wild animals, sanitation of building, tools, and equipment, soil amendments of animal origin, and worker health and hygiene.

• Provides the accreditation framework, procedures and requirements that third-party auditors must meet to receive certification.

• Importers can use certifications to 1) expedite the review of entering the country or 2) have a food certified by an accredited third-party auditor when the FDA determines circumstances are warranted.

FSMA Rules for Processed Foods

Below is an overview of the FSMA rules for processed foods, and summarizes the requirements for food entering the U.S. supply and distribution chains. For full requirements, please see the appropriate FSMA rule.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventative Controls for Human Food) 

• All domestic food production facilities must comply with the modernized Current Good Manufacturing Practices.

• Food production facilities that must register with the FDA are also governed by the Preventative Controls for Human Food rule.

• A written HARPC food safety plan must be developed, implemented, monitored, and verified.  A recall plan is a required component of every facility having a preventative control.

• Where an identified hazard will be controlled in a facility’s supply chain (through further processing by the facility's customer) the facility is required to have a supply chain program. Specific documentation is required.

• Two definitions of Farm are specified – Primary Production Farm, and Secondary Activities Farm.  Farms meeting either of these definitions are not governed by the Preventative Controls for Human Food rule.

Very similar to the Preventative Controls for Human Food, this rule ensures the safety of food used for livestock as well as pets.

• Covers human food by-products (whether sold or donated) that will be used as animal food. Facilities must comply with the Current Good Manufacturing Practices except as noted below.

• Heated by-products for animal food must comply with Current Good Manufacturing Practice for either human food or animal food.

• If by-products were made under the Preventative Controls for Human Food, no further preventative controls need to be implemented.

• If by-products are being held only, then no additional Current Good Manufacturing Practices need to be implemented except to prevent contamination.

• A written HARPC food safety plan must be developed, implemented, monitored, and verified.  A recall plan is a required component of every facility having a preventative control.

• Two definitions of Farm are specified – Primary Production Farm, and Secondary Activities Farm. Farms meeting either of these definitions are not governed by the Preventative Controls for Animal Food rule.

• Applies to human and animal food transported by rail or motor vehicle into the U.S. and entering the food supply and distribution chains. Food transported across U.S. borders by rail or motor vehicle, and not entering the U.S. food supply, is not covered by this rule.  

• Export companies transporting food out of the country are covered until the shipment reaches a port or the U.S. border.

• Loaders, motor vehicle or rail shippers, carriers and receivers are covered by this rule. Waivers are provided for 1) certified National Conference on Interstate Milk Shipment for certain Grade A milk and milk products, and 2) food establishments such as grocery stores, restaurants and home grocery delivery operations holding valid local jurisdictional permits and delivering food from their establishment to the customer.  

• Provides sanitary requirements for vehicle and transportation equipment, transportation operations, training, documentation and recordkeeping.

Assures foreign food suppliers are providing human and animal food meeting FSMA level compliance at the time of importation.

• Covered importers are U.S. owners or consignee, or U.S. agency or foreign owner or consignee representative at the time of entry.  

• Importers are responsible for verifying foreign food suppliers are compliant with the appropriate FSMA rule, and taking corrective action if necessary.

• A written HACCP plan and mitigation plan are required of all foreign food suppliers.  

• Importers are considered to be in compliance with the major elements of the Foreign Supplier rule if they are also processors or manufacturers and are in compliance with the applicable FSMA rule governing that food.

• The Foreign Supplier rule specifies: 1) criteria which supplier verification activity must be conducted: annual onsite audits, sampling and testing and records review, 2) corrective action procedures, and 3) exemptions and modifications to the rule.  

• Importers are allowed to rely on third-party verification entities for verification of Foreign Suppler activities.

Protecting the U.S. food supply from economically motivated adulteration.

• Targets processes in large domestic and foreign FDA registered food facilities.

• Requires covered companies to develop a written Food Defense plan, identify and assess the vulnerabilities of each type of food processed, manufactured, packed or held at the facility. For each vulnerability identified, mitigation strategies must be developed to minimize or prevent the vulnerability, and management and monitoring procedures to verify effectiveness.

• Many companies covered by the Food Defense rule, will also be governed by other FSMA rules.  With this in mind, FDA has extended the timeline for companies to comply with the Food Defense rule.

Three Types of Food Safety Plans 

Through this discussion of the seven FSMA rules for processed foods, you may have noticed the mention of several food safety systems. All are based on prevention, but they each have a different focus.  Below is a very brief overview:

HARPC (Hazard Analysis and Risk-Based Preventative Controls)

FDA mandated through FSMA, this food safety plan has a broader scope than HACCP, in that is looks at all risk points, known or reasonably foreseeable hazards, with the intent of proactively taking steps to significantly minimize or prevent the hazard. Chemical, biological and physical hazards, as well as naturally occurring, intentionally and unintentionally introduced hazards are all part of HARPC.

HACCP (Hazard Analysis and Critical Control Points)

A globally recognized, voluntary, food safety standard primarily driven by retailers, auditors, and inspectors. An exception is where the FDA or USDA requires a HACCP plan for meat, seafood and juice production. HACCP looks at critical points in the food process system and applies controls to prevent, eliminate or reduce the hazard to a safe level.  Minimum temperature and time requirements when cooking meat, is one example.

An FDA mandated food safety system that is vulnerability based.  Developing a Food Defense Plan is similar to developing a HACCP plan. Each step in the production of a food is evaluated for several criteria and actionable steps put in place to mitigate the vulnerability.  This is a new type of food safety plan, introduced with the Food Defense rule.

FSMA Rule Compliance Dates 

Compliance dates for each rule are dependent on the published date of the finalized rule and the size of the covered company. For a comprehensive list of compliance dates for all rules, click here. To learn more about the FSMA Rules, click here.

See how EHS Insight can help you document your FSMA compliance.