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From: Food Quality & Safety magazine, December/January 2012

Nuts and Bolts of FSMA

Essential elements of the Food Safety Modernization Act—and how organizations can get prepared

by Katie Dowling and Mohan Ponnudurai

Because a breakdown at any point in the farm-to-table food supply chain can threaten the health and safety of consumers and cause serious financial repercussions for food manufacturers, the FSMA integrates with and expands the FDA’s currently established safety practices for poultry, seafood, juice, produce, and eggs, making prevention easier throughout the domestic and international food system.

Other key regulatory changes introduced by the FSMA include:


The FDA will have the authority to issue direct recalls of potentially contaminated food items, rather than relying on individual producers to issue recalls.


Food safety plans, such as hazard analysis and critical control points plans for implementing corrective actions, will be required and must be accessible to the FDA at all times with short notice.


The U.S. Department of Health and Human Services will implement a food tracing system to streamline the process of pinpointing the source of contamination in case of an outbreak. This includes the source of the original ingredients as well as the final products (lot numbers) in which these ingredients were used.

Import compliance

Food product importers will be responsible for verifying the safety of imported food products and confirming that they are in accordance with U.S. food safety guidelines.

International cooperation

The FDA will establish field offices inforeign countries and collaborate with local regulatory agencies. Although the legislation will clearly affect food manufacturers, many of the principles it contains are similar to existing industry best practices. For example, HACCP already requires processors of all food types to evaluate hazards in their operations; implement and monitor effective measures to prevent contamination; and, in case of contamination, take corrective actions as necessary. Those organizations that already comply with guidelines like the HACCP are less likely to require implementation changes to meet the requirements of the FSMA, but all organizations should be aware of the consequences of noncompliance.

With the passage of FSMA, the FDA gains the authority to ensure that a manufacturer’s plans are adequately and properly implemented, with commensurate power to suspend company registration and levy fines. Additionally, the FDA will require food importers to verify the safety of all suppliers’ products, blocking any shipments from entities that deny inspection by the FDA. At the same time, the food safety legislation also calls for stronger collaboration with other foreign food safety agencies and improved regional training at various levels to ensure a well-integrated, efficient, and effective food safety system.

Anticipated Changes

The FSMA encompasses a number of participants in the food supply chain, providing specific requirements for each participant’s compliance. A closer look at specific areas of change and the kind of effects these requirements will have on the industry is provided below

Although the legislation will clearly affect food manufacturers, many of the principles it contains are similar to existing industry best practices. For example, HACCP already requires processors of all food types to evaluate hazards in their operations.

Track, manage, and report

With the FDA’s new authorization to issue immediate recalls, organizations must be able to quickly provide the appropriate data required to trace a source of contamination. There is a spectrum of reasons for organizations to prepare for this new requirement, from limiting the spread of an outbreak and speeding the time to recall to lowering the impact of noncompliance, including financial costs and damage to brand image. Today’s technology solutions help automate the process; for example, electronic record-keeping allows companies to track each product batch or lot with the geo-location from the point of origin to its current position in the supply chain. Third-party accreditation: The FSMA provides the FDA with the authority to require certification for high-risk international food imports to the U.S., as well as the right to inspect and to validate third-party accreditation. Any organization working with a foreign supplier—and that number will only increase as the food supply chain becomes more global—should ensure that the producer is FDA-certified.

Preventive controls

The FSMA mandates that the FDA identify the most significant food safety threats, such as foodborne contaminants and diseases, and update regulations every two years. These updates naturally impact the hazards identification and mitigation plans and controls in place at all food manufacturers, who will now need to revise plans, train personnel, and audit suppliers every two years to ensure they meet new preventive measures. Organizations that fail to enact the new registration process or to meet the updated requirements can risk suspension. Food production facilities must also advise the FDA of the hazardous practices currently in place and of their plans to implement preventive measures going forward. Because these plans are subject to FDA audits, organizations should ensure proper record-keeping when identifying hazardous practices, hazard prevention, sanitation procedures, employee hygiene training, environmental monitoring programs, food allergen control programs, mitigation plans, and corrective actions. Not only does this help organizations prepare for audits, but also it aids companies with internal operational and compliance audits as well.

Expanded authority

As the FSMA is implemented across the food and beverage industry, the FDA will also gain wider authority to access food production facilities’ records every time a suspected potential public health risk arises. As a result, organizations should implement a system, such as an automated web-based quality and compliance management system, that will record and maintain food safety-related information, as well as rule and workflow-based business processes to manage these compliance and safety critical processes. This will help companies to hand the relevant, requested records to the FDA quickly, while also providing trending and dashboard visibility to management teams for proactive decision making throughout the process.

How to Prepare

The full implications of the FSMA will be revealed over time, but organizations can and should expect that substantial portions of the FSMA will be implemented within three years, and many will be effective within the next two years.

One major element missing from current mandates and provisions in the FSMA is electronic records, which are not required but are nonetheless critical for producers to prove traceability. Because the FSMA does provide the FDA with expanded access to facility records and requires those producers to quickly recall their products, food companies should proactively evaluate how they capture, record, and manage information.

Most of the required traceability elements are covered under enterprise resource planning systems, the rest of the compliance elements under an enterprise quality management system. The typical EQMS currently used by FDA-regulated companies under 21CFR11 or 21CFR820 compliance is easily adapted for FSMA compliance. Such a system, paired with FDA accepted best practices, could also help organizations in the following critical areas:

  • Hazards analysis, control plans, and mitigation;
  • Corrective and preventive action and remediation management;
  • Employee safety and competency training;
  • Internal and external audit management; and
  • Supplier management.

The FDA’s management of regulations in the life sciences sector is a good indication of how the agency might also approach the new regulations in the FSMA. Beginning with the largest food companies, whose products “touch” the broadest spectrum of people, the FDA will likely work from the top to the bottom of the food supply chain.

Additionally, because major food manufacturers will be responsible for their suppliers, a top-down approach enables larger organizations to cover a swath of smaller suppliers as part of safety tracking and food safety/quality. Organizations should start to prepare for FSMA requirements by proactively evaluating the systems, processes, and technology needed to meet new regulatory standards.

Mohan Ponnudurai is an industry principal at Sparta Systems, addressing the needs of the food and beverage and oil and gas sectors on how automated quality and compliance solution can be used to manage, track, and improve food safety processes globally. Katie Dowling is a senior solutions consultant at Sparta. She tracks trends in the food and beverage and manufactur­ing industries.



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