fsma

The Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by implementing best practices and requirements designed to prevent foodborne illnesses in consumers. Many of the FSMA provisions relate directly to the supply chain and keeping food and beverage products safe, fresh and enjoyable.

Here are eight things those within the supply chain need to know about FSMA:

Best Practices Apply

Under the Sanitary Transportation of Human and Animal Food rule within FSMA, shippers and carriers involved in transporting human and animal food must follow recognized best practices, such as protecting food during transportation, properly refrigerating it and cleaning vehicles between loads. The rule applies to foods transported in bulk (such as milk), packaged foods not fully enclosed in a container (such as fresh produce), and foods that require temperature controls for safety.

Shippers Hold the Most Responsibility

The primary responsibility for determining appropriate transportation operations rests with shippers, but they may rely on contractual agreements to assign some of these responsibilities to other parties. Specifically:

  • Shippers must develop and implement written procedures to ensure that equipment and vehicles are in appropriate hygienic condition.
  • Shippers of food transported in bulk must develop and implement written procedures to ensure that previous cargo does not make food unsafe.
  • Shippers of foods that require temperature control for safety must develop and implement written procedures to ensure that food is transported under adequate temperature control.

Requires Strict Procedures and Record-Keeping

As part of FSMA, the Food and Drug Administration (FDA) requires carriers to develop and implement written procedures subject to record-keeping that outline practices for cleaning, sanitizing and inspecting vehicles and transportation equipment used to transport food. Carriers must keep records of their processes that prevent contamination and ensure all training requirements are met. They must also maintain written procedures and records related to equipment cleaning, prior cargoes and temperature control for up to 12 months.

The Ability to Track-and-Trace Is Essential

Under FSMA, those within the supply chain must be able to track and trace products in the event of a recall. Utilizing warehouse management systems, transportation management systems and GPS monitoring can help pinpoint the exact location of food products quickly.

Temperatures Are Critical

When food requires specific temperature parameters, vehicles and transportation equipment must be able to provide adequate temperature control. The shipper and carrier can agree to a temperature-monitoring mechanism for foods within the trailer or truck body, and carriers must provide temperature-related documentation. If a covered person or company at any point in the supply chain becomes aware of a possible temperature failure or condition that could make food unsafe, the food cannot be sold or distributed until it is determined to be safe.

Supply Chain Partners Must Share Information

FSMA establishes procedures for exchanging information about prior cargoes, cleaning of transportation equipment and temperature control between the shipper, carrier and receiver.

Training Is Required

Training of carrier personnel, even temporary employees, in healthy transportation practices is required as part of FSMA when the carrier and shipper agree that the carrier is responsible for clean conditions during transport. What’s more, training must be documented and available for inspection.

There Are New Requirements on the Horizon

While FSMA has been around for years, the FDA continues to roll out new requirements. One of the latest, the Food Traceability Rule, mandates additional traceability record-keeping requirements for certain foods and takes effect on Jan. 20, 2026. Also, in January 2023, the FDA released new guidance on the requirements for a foreign supplier verification to ensure food imported into the United States meets applicable requirements, is not adulterated and does not have misbranded allergen labeling.

It's essential for those working with food to be current on the latest requirements and best practices. Penske Logistics has earned Cold Carrier Certification, adding to its strategic approach to safety. The certification, which is the first of its kind, recognizes cold trucking carrier companies that comply with the Refrigerated Transportation Best Practices Guide from the Global Cold Chain Alliance, a trade association representing all major industries engaged in temperature-controlled logistics. Additionally, Penske associates undergo regular training to ensure food safety.

The Food and Drug Administration (FDA) has issued new requirements for additional traceability records for certain foods, ranging from nut butters to cut veggies to shrimp, under the Food Safety Modernization Act (FSMA). The requirements, which take effect on Jan. 20, 2026, create new traceability record keeping requirements beyond those in existing regulations for certain foods. All entities in the supply chain will be subject to the Food Traceability Rule.

The FDA said the changes, which require entities to share information with others in the supply chain, will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

The list of foods includes some cheeses, eggs, certain vegetables, including cucumbers and leafy greens, some fruits, including melons and tropical tree fruits, fresh-cut fruit and veggies, some fish, nut butters, and ready-to-eat deli salads, such as egg salad, potato salad, pasta salad and seafood salads.

In preparation for the new requirements, which are less than three years away, it’s essential to start evaluating current warehouse management system (WMS) capabilities now to be best prepared for the near future. Since traceability in our food supply chain is essential to providing better service to our customers and end consumers, and a detailed record-keeping system is important for all the foods we handle in our food chain, making updates now will lead to a seamless transition when the new requirements become mandatory.

Key Data Elements and Critical Tracking Events

As part of the rule, those who manufacture, process, pack or hold foods on the Food Traceability List (FTL), must maintain and provide to their supply chain partners specific information — called Key Data Elements (KDEs) — for certain Critical Tracking Events (CTEs), in the food’s supply chain.

For example, if a distribution center (DC) receives the repacked fresh cucumbers from a produce processor, it must keep records on the receiving KDEs of the fresh cucumbers. Since the DC will be shipping the cucumbers to a retail store, it must maintain KDEs related to the shipping of the cucumbers to the next point in the supply chain, the retailer. The DC must also send the KDEs to the retailer.

Records must be kept regarding where the shipping event began and where it ended, meaning where the food was received. Still, the FDA said it is unnecessary to have records of the food's route, including any instances where it may have been moved from one carrier to another. Also, for cross-docking situations where food is arranged for transport from point A to point B but is briefly placed on a loading dock at point X at the DC to be transferred from one truck to another, records don’t need to be kept for point X.

Key Data Elements for those receiving food include:

  • Traceability lot code for the food
  • Quantity and unit of measure of the food
  • Product description for the food
  • Location description for the immediate previous source (other than a transporter) for the food
  • Location description for where the food was received
  • Date the food was received
  • Location description for the traceability lot code source or the traceability lot code source reference
  • Reference document type and reference document number

Key Data Elements (to maintain and provide) for those shipping food include:
  • Traceability lot code for the food
  • Quantity and unit of measure of the food
  • Product description for the food
  • Location description for the immediate subsequent recipient (other than a transporter) for the food
  • Location description for the location from which the food was shipped
  • Date the food was shipped
  • Location description for the traceability lot code source or the traceability lot code source reference
  • Reference document type and reference document number (maintain only)

Traceability Plan

All parties covered by the rule must create a traceability plan, and several are specific to those holding the food, such as a DC. The plan must include a description of the procedures used to maintain the required records, including the format and location of the records. It also needs to have a description of the procedures used to identify foods on the FTL and a statement identifying a point of contact for questions regarding the traceability plan and records. Traceability plans must be updated as needed to ensure the information reflects current practices and previous traceability plans must be maintained for two years after an update.

The Importance of Equipment, Technology and Training

There are several layers to the FSMA, which was signed into law in early 2011, and several requirements apply to the transportation and storing of food. All parties in the supply chain need to ensure they’re complying with current requirements and prepared to meet upcoming compliance dates.

FSMA includes requirements surrounding vehicles and transportation equipment, which must be “adequately cleanable” to allow the sanitary transport of food and “must be stored in a manner that prevents harborage of pests or becoming contaminated in any other manner that could result in food becoming adulterated.”

The ability to track and trace products is at the heart of several requirements, making the right WMS a vital resource. Tier 1 systems provide information on where products are stored and have embedded algorithms that can find ways to maximize productivity and the movement of product in and out of the warehouse.

It is also important for those transporting and storing food to be current on the latest requirements and best practices. Penske Logistics has earned Cold Carrier Certification, adding to its strategic approach to safety. The certification, which is the first of its kind, recognizes cold trucking carrier companies that comply with the Refrigerated Transportation Best Practices Guide from the Global Cold Chain Alliance, a trade association representing all major industries engaged in temperature-controlled logistics. Additionally, Penske associates undergo regular training to ensure food safety.

Foods on the Traceability List

Foods that will be subject to greater requirements in 2026 include:

  • Cheeses, other than hard cheeses
  • Shell eggs
  • Nut butters
  • Cucumbers
  • Herbs (fresh)
  • Leafy greens (fresh and fresh cut)
  • Melons
  • Peppers
  • Sprouts
  • Tomatoes
  • Tropical tree fruits
  • Fruits (fresh cut)
  • Vegetables (fresh cut)
  • Finfish
  • Smoked finfish
  • Crustaceans
  • Molluscan shellfish, bivalves
  • Ready-to-eat salads

Learn more at:

https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list