The Food Safety Modernization Act (FSMA) is the most sweeping reform of U.S. food safety laws since the Food, Drug and Cosmetic Act of 1938. The FSMA was signed into law by President Barack Obama on Jan. 4, 2011. The act’s central goal is focused on improving the safety of the U.S. food supply.  It was created in response to several incidents of food-borne illnesses during the 2000s. Tainted food has cost the industry billions of dollars in recalls, lost sales and legal expenses.

The FSMA charges the U.S. Food and Drug Administration (FDA) to develop regulations that ensure the U.S. food supply is safe by proactively aiming at contamination prevention rather than responding to contamination outbreaks. This simple idea has sent shockwaves throughout the industry, forcing beverage processors to consider many processing issues.  From farm to fork, every link in the chain has increased regulatory scrutiny, and the repercussions of a failure are more costly than ever.

How the FSMA will impact the beverage industry

The implications of the FSMA on the beverage industry can be categorized in two ways: direct and indirect.  The direct impacts include required food safety plans and higher scrutiny by regulators.  The FSMA requires food facilities to evaluate potential hazards, implement and monitor precautionary measures to prevent contamination, and create plans to take any necessary corrective actions.  

Although these direct impacts are incredibly important, they do not show the whole picture. Ripple effects are being felt in the industry that are reshaping engineering practices. The FSMA has created a new design game for beverage processors.  Clean design principles are dominating the conversation among manufacturers, with the FSMA being the driving force. Processing, storage and transportation systems are being designed so they can maintain sanitary conditions and not contribute to product contamination.

The FDA also has new requirements to ensure that imported beverages meet U.S. food safety requirements. FSMA creates additional accountability for importers by requiring them to verify that their foreign suppliers have adequate preventive controls in place to ensure safety. The FDA will be able to accredit qualified third-party auditors to certify that foreign facilities are complying with U.S. food safety standards.

Keys to compliance

By now, all beverage producers should have registered with the FDA, where they will be placed in risk assessment pools. Processors designated as high risk will be inspected more frequently to gauge compliance with the FSMA and other regulations. Beyond this requirement, the key to compliance for many processors is the development of a food safety plan.

The key provision in the law that drives the contamination prevention mandate is FSMA Section 103, Hazard Analysis and Risk-Based Preventive Controls. This section requires that registered facilities implement a written preventive controls plan. The plan includes the following elements:

• Evaluating the hazards that could affect food safety and product risk;

• Specifying what preventive steps or controls mitigate the most likely risks from reaching the public  and engineering out the risk to the greatest extent possible or developing critical control points;

• Specifying how the facility will monitor these controls to ensure they are working; maintaining routine records of the monitoring; and

• Specifying what actions the facility will take to correct problems that arise (i.e. product recall).

This plan also is commonly known as a Hazard Analysis and Critical Control Points (HACCP) plan. This predictive analysis of the likelihood of potential hazards allows the areas of greatest concern to be addressed. Critical control points (CCP) or processes are documented and changes may be needed to reduce risk of contamination. At a minimum, the CCPs need to be tracked and monitored to ensure proper warning is given should a potential contamination situation arise.

What should you do next?

A good start is to better understand the requirements of the FSMA and the shifting dynamics of the U.S. food-safety landscape.  Once you better comprehend where things are headed, work to get out front.  The following are two critical tasks.

Facility and supply chain audits: Understand and address vulnerabilities through an assessment of internal manufacturing systems and gain greater upstream visibility of the supply chain. It is important to try and pick an outsider to assist in this.  This will help gain new perspective on risks and what others are doing to mitigate them.


• HACCP plan development and implementation: By reviewing processes, a deeper insight into the risks for contamination can be gained. For example, when making products in a machine, it is possible for a piece of that machinery to break off, placing metal into the product. The hazard, metal in the product, would then need to be reviewed in this HAACP plan for likelihood of occurrence, effect on the consumer, and other factors giving the producer a risk factor. In this example, if the risk were deemed high, the producer would move to prevent the hazard from happening by engineering it out. However, if engineering cannot remove the likelihood of occurrence, then critical control points would be put in place. Processes would be developed to ensure metal is identified as soon as possible, notifying the operations people or even shutting down the process.

 Food and beverage chain stakeholders are faced with many challenges including product quality, continuous improvement, regulatory compliance, and a safety program that spans the enterprise and extends to the supply chain. The FSMA has clear impacts. Legislators, consumers and manufacturers alike can read and understand the requirements. But the requirements, as powerful and persuasive as they might be, are merely words. What goes on inside the walls of beverage processing facilities is where the real change occurs.

Related: FSMA takes a preventive approach to safety, Food safety focus on packaging