Commercial farms, food processing facilities, food packing operations, restaurants and other businesses that are regulated by the FDA must comply with FSMA. In addition, businesses that must maintain hazard analysis and critical control points (HACCP) management systems for juice and seafood production also are typically subject to FSMA requirements.

The FDA regulates about three-quarters of the US food supply, including 35,000 produce farms and 300,000 restaurants. The remaining quarter is regulated by a patchwork of state and federal agencies that collaborate to help keep the nation’s food supply chain safe. State-level departments of agriculture and public health work side by side with the FDA, the US Department of Agriculture (USDA) and other federal agencies, with each regulator playing an important role:

• Food Safety and Inspection Service (FSIS): Part of the USDA, FSIS oversees the labeling and packaging of commercial meat, poultry and egg products.
  
  
• FDA: Primary public health regulator for all food that’s not regulated by FSIS, and cosmetics, dietary supplements, tobacco, medicine, pharmaceuticals for humans and animals, vaccines and other biologics, and medical devices.
  
  
• Centers for Disease Control and Prevention (CDC): A national public health agency that tracks and investigates foodborne illness outbreaks, and surveillance and response efforts when pathogen contamination occurs.

FSMA provides exemptions for small manufacturing facilities and local food providers that produce and sell food in their own communities. To help organizations with FSMA compliance, the FDA, USDA and Cornell University’s Produce Safety Alliance also provide technical assistance, FSMA training, and education and outreach opportunities to the small business community.

In implementing FSMA since 2013, the FDA has issued 16 final rules detailing requirements for industry stakeholders. These guidance documents outline for enterprises the various operational changes that must be implemented to remain compliant in specific areas, including:

Under FSMA rule 204(d), organizations that manufacture, process, pack and hold any items on the FTL must gather and maintain key data elements (KDEs) about critical tracking events (CTEs) in what the FDA defines as the “farm-to-table continuum.” These CTEs include:

• Harvesting: The removal process of raw agricultural commodities (RACs) on a farm or similar facility where they are grown, raised or prepared.
  
  
• First land-based receiver: A designation assigned to the first individual or entity that takes possession of a food item for food obtained directly from a fishing vessel.
  
  
• Cooling: Any active process for reducing the temperature of RACs, including vacuum cooling or the use of ice (for non-seafood food products), hydrocooling or traditional air conditioning.
  
  
• Initial packing: For food not obtained from a fishing vessel, the first-time packing of a RAC.
  
  
• Shipping: A supply milestone representing the movement of food “from one location to another location.” This CTE does include intracompany shipments but not direct-to-consumer sales or donations.
  
  
• Receiving: A supply chain milestone that signifies a food item’s arrival at another physical location after it has been shipped. This CTE does include intracompany shipments but not direct-to-consumer sales or donations.
  
  
• Transformation: The manufacturing, processing, commingling, repacking or relabeling of a finished food item that’s on the FTL.

All FTL food must be assigned a unique alphanumeric identifier or descriptor, called a traceability lot code (TLC), when it is initially packed as RAC, received directly from a shipping vessel or transformed into a regulated food. FTL foods received from enterprises that are exempt from the FDA’s FSMA rules must also be assigned a TLC by nonrestaurant recipients.

For a typical 15-store grocery chain that receives an average of three shipments per week, the National Grocers Association estimates that each CTE might require 117,000 data points per year.

The FDA’s Food Traceability Final Rule also requires farms and restaurants to establish a traceability plan. For farms and food establishments, the minimum traceability information requirements include:  

• A description of how records are maintained
  
• A description of how FTL foods are identified
  
• A description of how TLCs are assigned
  
• A designated point of contact
  
• A farm map of where FTL foods are grown
  
• All updates to the traceability going back two years

In addition, organizations are required under FSMA Section 204(d) to maintain original paper, electronic or true copies of traceability plans and other related documentation. 

Farms and food establishments produce these records within 24 hours of an FDA request. Similarly, in the event of “an outbreak, recall or other threat to public health,” organizations must produce an electronic sortable spreadsheet that contains “relevant traceability information” within 24 hours of a request.

On its website, the FDA provides comprehensive guidance detailing how organizations can meet food traceability rules and other record-keeping requirements under FSMA rule 204(d). The agency also offers a downloadable electronic sortable spreadsheet that can help organizations develop compliant traceability systems.  

Enterprises that fail to comply with FSMA’s food pathogen contamination-prevention provisions are prosecuted under the Food, Drug and Cosmetics Act. In publishing its rules on traceability, the FDA has indicated its desire to work with food industry stakeholders “to prompt voluntary compliance.” Still, the agency has indicated publicly that it might take certain enforcement actions for FSMA noncompliance, such as:

• Issuance of advisory letters
• Seizures, injunctions and other court actions
• Administrative detention
• Mandatory recalls
• Suspension of food facility’s registration

IBM helps organizations meet FSMA Section 204(d) traceability requirements through compliance management solutions that meet the needs of enterprises, regardless of size. These tools use decades of experience in the development of food traceability software so stakeholders can connect their entire food supply chain.
 

iFoodDS and IBM partnership
 

Comprehensive FSMA Section 204(d) traceability and compliance management solutions from iFoodDS and IBM also help organizations with interoperability and scalability challenges through deep innovative food industry, regulatory and technical expertise.

A collaborative network of growers, processors, wholesalers, distributors, manufacturers and retailers, the IBM and iFoodDS partnership enhances visibility and accountability among organizations and their supply chain partners. Built on IBM Blockchain®, this solution connects participants through a permissioned, immutable and shared record of food provenance, transaction data and processing details.

In addition, IBM Consulting® works closely with enterprises to help them modernize both their supply chains and their entire data landscape. This holistic approach helps organizations meet new regulatory requirements, realize cost savings and create value for their customers. 

Find more information on the IBM and iFoodDS partnership or IBM Consulting at IBM.com.