Updates and a Recap on FSMA Section 204(d) FDA's Proposed Rule for Food Traceability

Eric Edmunds (TAG)
Contributing Writer

After a series of large-scale food recalls due to contamination, the Food and Drug Administration (FDA) decided to overhaul the food safety system with the most sweeping reforms seen in decades. Then-president Obama signed the Food Safety Modernization Act into law in 2011, starting a cascade of fundamental shifts in how the FDA regulates food safety from end-to-end. Implementation of FSMA has been an ongoing process because of the size and scope of the new regulations.

What Is FSMA Compliance?

The FSMA spells out requirements for businesses based on size with the Preventive Controls for Human Food Rule. The Foreign Supplier Verification Program (FSVP) Rule applies to importers of both human and animal foods. The FDA also introduced the International Adulteration Rule, designed to prevent intentional acts that could cause large-scale public health issues. Six components within the FSMA provide the structure for proactive safety prevention:

  • Product and Facility Plan

Food companies governed by FSMA must develop a written food safety plan for each product or group of similar products and the facility itself. A food safety plan could require thousands of plan components, incorporating PRPs, CCPs, specifications, and more. Producers must also have verifiable proof that they are implementing and continuously monitoring product and facility plans.

  • Risk Assessment

Developing an FSMA compliant food safety plan requires a robust risk assessment. To examine possible hazards throughout the supply chain, companies must identify and evaluate all risks that are reasonably likely to occur. After that, they must determine the most significant risks. While the FDA does not provide a formal definition of significance, FSMA indicates that if someone knowledgeable in food safety saw the risk as a hazard they would want to control to protect the public, producers should consider the risk significant.

Potential hazards can include biological, chemical, and physical risks. To identify risks, food safety professionals can consider previous experiences with the product, its past history, or the history of similar products.

  • Preventive Controls

Once producers have identified risks, the next step is to establish controls to mitigate them. Producers should design the preventive controls within the food safety plan to do everything possible to prevent potential risks from occurring. The FSMA food safety plan controls can extend beyond hazard analysis critical control points (HACCP) and include process controls, allergen controls, sanitation controls, training, and recall plans.

  • Monitoring and Verification

The only way to confirm an FSMA food safety plan is effective is to actively monitor, verify, and validate preventive controls. The FDA requires continuous monitoring, so producers must present plans during audits as well as proof of ongoing tracking. The primary purpose of FSMA is to prevent food safety outbreaks rather than respond to issues after they arise.

Tracking FSMA plan performance is ultimately up to the discretion of each company. However, tracking controls on an ongoing basis and documenting results are two crucial aspects of a successful plan. To ensure effectiveness, companies can: 

  • Measure specific parameters such as temperature

  • Monitor the hygienic condition of the environment

  • Test products 

  • Find a similar means of tracking data

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  • CAPA and Reanalysis

Under FSMA, Corrective/Preventive Actions (CAPAs) must be in place when preventive controls fail. Producers must revisit plans and controls periodically to determine whether they can identify any areas of improvement. Generally, producers should reexamine plans at least every three years, or if a failure in preventive controls causes a food safety incident. The objective of an FSMA food safety plan is to proactively identify CAPAs so prompt remedial action can take place if necessary.

  • Documentation

With FSMA, producers must document every FSMA food safety plan component, including the programs that make up the plan, proof of completion and validation, all test results and supplier documents, and CAPAs. The objective is for each facility to tell a narrative about its FSMA food safety plan. A single, unified system of records makes composing this narrative simple. Modern food safety solutions allow users to record, store, track and retrieve all of the pieces of data for an FSMA food safety plan with ease.

What Are the 4 Types of Food Hazards?

The four categories of food hazards are:

  1. Microbiological hazards, such as:

  • Yeast

  • Bacteria

  • Molds

  • Viruses

2. Chemical hazards, including:

  • Water

  • Pesticides

  • Environmental, process, or agricultural contaminants

  • Food additives

  • Pest control substances

3. Physical hazards, including:

  • Metal

  • Pest droppings

  • Glass

  • Packaging

4. Allergenic hazards, such as:

  • Eggs

  • Nuts, including both peanuts and tree nuts

  • Shellfish

  • Soy

  • Dairy

  • Wheat

  • Fish

  • Sesame

What Are the 7 FSMA Rules?

The FDA established seven rules that became final several years ago to guide the implementation of FSMA. All of the rules are geared toward prevention and providing transparency throughout the supply chain. The seven rules are:

  1. Preventive Controls for Human Food: Facilities must maintain safety plans describing how they'll identify and minimize hazards. 

  2. Preventive Controls for Animal Food: Confirms current practices and preventive controls for animal food. 

  3. Produce Safety: Institutes science-backed standards for produce packed, grown, harvested, and held on farms within and outside the US.

  4. Foreign Supplier Verification Program: This program requires importers to verify the originators of imported food used practices for protecting public health similar to those employed in the US. 

  5. Third-Party Certification: The certification program provides accreditation for third-party auditors who can conduct food safety audits and issue certifications for foreign producers.

  6. Sanitary Transportation: Requires that transporters use sanitary practices that ensure food safety.

  7. Intentional Adulteration: Requires both US and foreign facilities to examine their processes for vulnerabilities that entities could exploit to create widespread public harm.

What Is FSMA Section 204?

FSMA 204 mandates the FDA to designate which foods require additional recordkeeping requirements to protect public health. The Requirements for Additional Traceability Records for Certain Foods (Food Traceability) proposed rule drafts other recordkeeping requirements the FDA proposes. These requirements should make it easier to rapidly and effectively track the movement of food to prevent or mitigate a foodborne illness outbreak.

Your Complete Guide to the Finalized FDA Food Traceability Rule

Promoting the Benefits of Traceability

While there are some costs associated with instituting end-to-end traceability, the FDA feels the benefits of traceability far outweigh any potential costs. Consumer safety will benefit from a proactive approach to avoid the four food hazards rather than responding to them after the fact. However, there are multiple benefits beyond the health and safety of consumers at the point of consumption. Producers can develop a more resilient response based on the transparency that full traceability provides, which is more crucial than ever as markets become more competitive, and supply chains become more complex. Traceability could also result in more significant domestic and global movement toward sustainable environmental and labor practices within the food industry.

What are the FDA's Traceability Requirements?

Recordkeeping is the name of the game under the FDA's traceability requirements. Anyone who packs, holds, produces, or manufactures foods on the Food Traceability List would need to keep records containing Key Data Elements (KDEs) associated with Critical Tracking Events (CTEs). 

The Food Traceability List

Within the FSMA, the FDA has clarified some of the foods included in the food traceability list. Foods covered by the food traceability list include:

  • Cheeses other than hard cheeses (defined as less than 39% moisture)

  • Shell eggs

  • Nut butters

  • Cucumbers (fresh)

  • Leafy greens (fresh), including fresh-cut leafy greens

  • Melons (fresh)

  • Peppers (fresh)

  • Sprouts (fresh)

  • Tomatoes (fresh)

  • Tropical tree fruits (fresh)

  • Fruits and vegetables (fresh cut)

  • Finfish, including smoked finfish

  • Crustaceans

  • Mollusks, bivalves

  • Ready-to-eat deli salads

Critical Tracking Events and Key Data Elements

The FDA recently clarified which foods are covered by traceability rules. A critical tracking event (CTE) is every event in the supply chain involving growing, receiving, transforming, creating, or shipping food. Key data elements (KDEs) are the required records a company must keep at each CTE. Reference records are the records in which you maintain the KDE. These could be invoices, a bill of lading, or receipts. A traceability lot code is assigned at harvest or transformation events such as processing. Single-ingredient products will need to include the name of the commodity, but multiple ingredient products will include the product name after processing. 

Additional Requirements, Modified Requirements, and Exemptions

Growers must establish and maintain records containing and linking the traceability lot code to the GPS coordinates, defined as where a person would typically enter the farm. Sprouts growers, like within the produce rules, have special requirements. There are multiple steps before the sprouter gets the seeds, including:

  • Identifying and describing the location of the seed grower, conditioner or processor, packinghouse, seed supplier, and including dates for each activity

  • Providing a description of seeds and supplier lot codes

  • Providing date of receipt of seeds by sprouter

Receivers must establish and maintain records containing and linking the traceability lot code to:

  • The location identifier and the location description for the immediate previous source

  • Entry number assigned to food (if imported)

  • The location identifier and location description of where, when, and what time receivers received the food

  • The unit of measure and quantity of the food

  • The food's traceability product identifier and traceability product description

  • The location identifier, location description, and point of contact for the traceability lot code generator

  • Reference record numbers and types for documents containing the information

  • The name of the transporter that transported the food

Transformers must keep documentation when change occurs to a food, package, or label. An example of a transformation would be combining ingredients or processing through cutting, cooking, commingling, repacking, or repackaging. Rule 204 differentiates foods used in transformation from foods produced through transformation. Even changing the label is considered a transformation event. 

Creators and shippers must also keep specific records that include a traceability product identifier, location identifier, product descriptions, and more. The changes in records for creators do not apply to retail establishments concerning foods they do not ship, such as foods they sell or send directly to consumers. Shippers must include an entry number for imported foods, the name of the transporter, and additional reference record types. 

There are specific exemptions to the rule, including: 

  • Small originators, such as produce farms not covered by Produce Safety Rule, shell egg producers with fewer than 3,000 laying hens, and those with less than $25,000 in annual food sales

  • Farms when selling food directly to consumers

  • Food packaged on a farm when packaging maintains the integrity of food and prevents contamination or alteration, and labeling that reaches the consumer includes the complete address and phone number of the farm

  • Food that receives certain types of processing, such as commercial processing that adequately reduces the presence of microorganisms of public health significance, and shell eggs when all eggs produced at the particular farm receive treatment per 21 CFR 118

  • Produce that is rarely consumed raw (21 CFR 112.2(a)(1))

  • Transporters

  • Nonprofit food establishments

  • Personal consumption

  • Persons that hold food on behalf of others when they are not a party to the transaction and not in the business of distributing food

Some products will be partially exempt, including:

  • Commingled Raw Agricultural Commodities (RACs), including any commodity combined or mixed after harvesting but before processing. Partial exemptions do not apply to RACs covered by the Produce Safety Rule. If required to register with the FDA, the producer will need to keep records identifying the immediate previous sources of RACs

  • Retail establishments, including food purchased directly from a farm. Must maintain records for the name and address of the farm.

  • Farm to school and farm to institution programs (direct sales). Must maintain records for the name and address of farms.

  • Fishing vessels: Partial exemptions do not apply unless the fishing vessel is required to register with the FDA

  • If required to register, vessels must maintain records of the immediate previous source of food and immediate subsequent recipient of food

The Goal of FSMA Implementation

FSMA has overhauled the approach to food safety and is providing the structure and tools to proactively prevent potentially catastrophic events that could harm or sicken consumers. By bringing greater transparency to the supply chain, food origins, and all the events a food goes through before arriving on a table, the FDA hopes to create a safer experience through visibility.

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