The FDA Food Safety Modernization ACT and FSMA Compliance

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August 20, 2019

The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) makes shippers and carriers responsible for maintaining proper temperatures for food transportation within the United States, with the aim of preventing foodborne illness across the national food system. The FMSA impacts how food for both human and animal consumption is handled in transportation through hazard analysis, current good manufacturing practices, and preventive controls.

What are the FSMA requirements?

The FSMA gives the FDA new ways to regulate the way food is grown, harvested and processed. Carriers and shippers are under increased scrutiny by FDA inspections and are being held responsible for documenting that proper reefer temperatures are maintained throughout the cold supply chain. Under FSMA safety regulations, it is critical that drivers and transportation companies prove that a shipment of food was kept at safe temperatures all the way through its journey. Below we cover details over the seven major elements to the FSMA.

1.   Preventive control rules for human food.

If you are required to register with the FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act then you are required by the FSMA to have a written food safety plan. Food safety plans must include the following:

      1. Identification and analysis of potential biological, chemical, and physical hazards.
      2. Preventive controls to ensure food served to humans is not adulterated. Process controls, food allergen controls, and sanitation controls are all key to this part of the rule.

2.   Preventive control rules for animal food.

This rule follows a similar structure to the preventive controls for human food. Animal food facilities are required to comply with the preventive controls requirements similar to the preventive controls for human food facilities. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.

3.   Foreign supplier verification.

The final rule regarding Foreign Supplier Verification Programs (FSVP) requires verification of importers of food for human or animal consumption into the United States. Verification determines if the food that is being imported has been produced and handled in a manner that meets the standards of U.S. food safety laws. Importers must have written policy and procedures for ensuring food safety standards. Specific hazards that need to be identified are outlined here:

      1. Biological hazards, including parasites and disease-causing bacteria.
      2. Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens.
      3. Physical hazards, such as glass or metals.

4.   Protection against intentional adulteration.

Preventing intentional adulteration protects against widespread harm caused by acts of terrorism in the food supply. A good example of intentional adulteration is the Chicago Tylenol murders when Tylenol branded capsules were laced with cyanide. This incident lead to the packaging reform that still exists today. This rule enforces processes that prevent intentional adulteration, rather than outlining specific hazards.

5.   Sanitary transportation of human and animal food.

The goal of this rule is to prevent safety risks during transportation, such as failure to properly refrigerate food, improper cleaning of vehicles or handling of goods during loading/unloading, and failure to properly protect food while it is in transit.

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6.   Standards for growing, harvesting, packing, and holding of produce for human consumption.

This rule is also known as the Produce Safety rule and establishes science-based standards for growing, harvesting, packing and holding of fruits and vegetables. Some of the requirements focus on:

      1. Water quality
      2. Biological soil
      3. Domesticated and wild animals for grazing
      4. Working training, health, and hygiene
      5. Equipment, tools, and building safety.

7.   Accredited third-party certification.

This certification is a program for accrediting third-party certification bodies, also know as auditors, who are responsible for conducting food safety audits. Any organization looking to be recognized by the FDA must apply online.

There are many nuances to the FSMA but ensuring compliance isn’t as difficult as it may seem. If you’re in the business of transporting food for human and/or animal consumption, telematics solutions can help.

FSMA compliance

For transportation companies, complying with the FSMA is made easier with telematics and reefer trailer monitoring. Reefer monitoring refers to maintaining regulated temperatures in refrigerated trailers and containers, or reefers. Regulating reefer temperatures and maintaining temperature control is critical to shippers for several reasons:

      • Reefer monitoring helps prevent unsafe temperature fluctuations for shipments of perishable goods.
      • It helps save carriers money by reducing the number of rejected deliveries due to spoilage.
      • It helps carriers deliver quality goods, on time, with safety guaranteed.
      • It alerts drivers of potential issues with cargo while in transit so they can prevent spoilage.
      • Proving FSMA compliance is made easier with digital logs instead of paper.

FSMA training programs

There are a few training programs for FSMA compliance available including the Food Safety Preventive Controls Alliance (FSPCA) and the Hazard Analysis and Critical Control Points (HACCP). The FSPCA develops accredited training programs in human food, animal food, and foreign supplier verification for FSMA compliance. HACCP training is a preventive food safety program that helps train workers on identifying physical, biological, and chemical hazards while handling and preparing food.

Shippers involved in the cold supply chain have a responsibility to protect public health and safety by verifying that reefers are monitored and safe temperatures are maintained. Proper temperature tracking also helps reduce cargo waste due to spoilage and helps prevent rejected loads - all of which impact the cost of doing business.

The FSMA is designed to protect public health and safety by holding food facilities and carriers responsible and accountable. The Act covers proper handling of food while in transit and after delivery is received. Solutions exist today that can help with the safe transportation of food. If your business is working on solutions for FSMA compliance, reach out to the experts at Verizon Connect today to learn how telematics can help.

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