With the birth of the Food Safety Modernization Act (FSMA), the FDA has been armed with the necessary sanction to streamline the food safety system in the U.S. It has since issued seven proposed rules to farmers, manufacturers, and importers aimed at ensuring that our food is safe for consumption and that the issues of maintaining a global marketplace will be reduced, or at least well-managed.
However, this is merely the beginning of a long process. The authority of the FDA to enforce such mandates will do little good without the necessary resources and financial ability to guarantee that these rules are being implemented and that suppliers and manufacturers remain compliant.
The food and beverage industry is more global than ever. Food and beverage companies are more often purchasing raw materials from global suppliers in an effort to reduce costs. While these initiatives have succeeded in reducing costs and meeting inventory requirements, they have also reduced visibility into production processes and increased the risk of companies failing to meet the food safety standards enforced by FSMA. The proposed increase in funds will be used to support the ongoing efforts of the FDA and the CDC to increase their technical expertise, improve their import and domestic inspection capacity, and ensure a faster resolution to a foodborne disease outbreak.
In order to appropriately support FSMA with new required resources, training for inspectors, and education and technology assistance for the industry, the proposed $253 million in additional funding is expected to come from new user fees, specifically for imported foods. The user fees that the FDA has requested seem to have stirred up a bit of controversy, with some believing they will pay a fee and receive nothing in return, but proponents of this increased budget are merely ready to see FSMA become fully implemented and realize that this cannot happen without the appropriate funding.
At a time when the global economy is still on shaky ground, piling on more financial commitments for facility registrations and user fees on importers may result in food price increases for businesses such as restaurants or supermarkets, and eventually for consumers. In summary, the increase in prices will have an overarching impact on everyone in the market at a time when very few can afford it.
Enough to Make a Difference?
Although the idea of improving the food safety of consumers is to be applauded, the current funding cannot effectively support the effort and the resources needed to appropriately handle all the requirements imposed by FSMA. Food imports alone represent more than 15 percent of the food consumed by Americans, and in such a global supply chain network there can be hundreds and even thousands of suppliers to keep track of. For example, a single U.S. banana bread manufacturer imports its bananas from a handful of different countries. If one of those areas has a fungal outbreak and cannot properly communicate the issue to the company, then the lack of visibility into the supplier’s materials would hinder problem detection, negatively impacting overall product quality. There is a substantial need on both ends for a unified system to ensure the quality of consumer goods is maintained across the entire supplier network before products make their way onto store shelves.
Current budget allocation can support the regulatory framework of FSMA, but the management, monitoring, and inspections are just not properly staffed or trained to support these new requirements. Both the FDA and food and beverage companies should seriously consider investing in ROI-proven technologies, such as Enterprise Quality Management Systems (EQMS), to ensure the quality and safety of this country’s food supply.
Foreign Supplier Verification Programs, which aim to impose requirements on importers to perform certain risk-based actions that guarantee imported food meets the same level of public health protection as that of domestically produced food, are a big part of FSMA. The program relies on the importer’s ability to identify hazards with any of their food imports, provide documentation of verification activities, and prove that controls are in place to reduce or eliminate hazards at a critical point in the production and distribution of food products. This ties in directly with plans for Hazard Analysis and Critical Control Points (HACCP) that most regulatory or industry initiatives require, including FSMA, current Good Manufacutring Practices, Global Food Safety Initiative, Safe Quality Food, and European Union Directives, just to name a few. Providing this consistent proactive monitoring of production and logistics oversight is imperative to delivering safe food and beverages for consumers worldwide.
Back in February, the FDA’s deputy commissioner for foods and veterinary medicine, Michael Taylor, acknowledged these concerns to the House Commerce and Energy Committee by stating, “The determination that we have all made to improve the safety of our food supply requires two fundamental steps,” he said. “The first was to give FDA the mandate and tools to modernize the food safety system, and I applaud you for doing that via enactment of the FSMA. The second is to give FDA the capacity to carry out the numerous changes embodied in the law. It is that challenge that we must continue to address. Simply put, we cannot achieve our objective of a safer food supply without a significant increase in resources.”
The prevention of food safety issues such as product recalls is no light task. It is a feat that requires significant manpower, and manpower costs money—more money than the government is currently willing to supply. The existing funding for the food safety system is currently just a drop in the bucket. It is highly unlikely that these funds will cover the series of necessary audits that must be done nationwide. According to a survey conducted at this year’s Food Safety Summit, 55 percent of respondents believe that food auditors should be held responsible if a foodborne outbreak is traced back to an issue that wasn’t noted during an audit. This means that third-party auditors should be empowered to prevent issues. The manpower resources will be spread thin, and issues will likely fall through the cracks unless food and beverage companies look to automation and innovation to ensure food quality, safety, and compliance. Manufacturers and auditors alike can benefit from this, as they will be capable of easily tracking and documenting issues as well as how and when they were resolved. As a best practice, this automation of quality workflow processes is done via an EQMS.
What Can Manufacturers Do to Streamline Compliance?
Similar to other industries, quality is often managed via paper-based or spreadsheet reports in the food and beverage industry. The problem with this approach is that incidents and hazards, corrective actions, and change management are then silo’d in a manual records system and are not able to be queried easily. It can be nearly impossible to isolate specific issues that manufacturers and suppliers have had in the past, which is why it makes the most sense to keep all of that data in one place. For instance, with corrective and preventative action software, just one of the many parts of an EQMS, food and beverage companies are able to not only track a wide variety of incidents from different sources, but also manage incidents more appropriately through automated alerts and extensive reporting capabilities when issues do arise. By automating all of these quality processes in a central repository, food and beverage companies can more easily identify trends and issues across multiple facilities earlier in the process. This practice has already proved successful in the pharmaceutical industry, a vertical that is also heavily regulated by the FDA. Technology advancements like EQMS have made it possible for pharmaceutical companies to remain compliant and reduce the risk of issues such as product recalls.
If a company can catch mistakes early on, they have the ability to make necessary changes before the issue is released into the marketplace, thus another way to proactively protect consumer health and safety. When manufacturers have a change management system in place as part of their EQMS, they are able to monitor this change request process from start to finish with one system, creating a standardized and streamlined method that alleviates the potential for mistakes.
The most promising way to go about addressing these issues more proactively is to ensure quality processes are transparent across the organization, as well as its entire supplier network. If companies can maintain visibility into the entire supplier network, fewer compliance audits would be needed because all of the data and information is already compiled in a quality management system, and therefore the company has more control of its supply chain and current product development cycle.
Companies would be able to verify that incidents, investigations, corrective actions, and change management were monitored in one system, assigned to specific employees for resolution, and closed per requirements. There would be no deviation from standard operating procedures or compliance requirements, which provides reassurance for both the company and the inspector, thus streamlining the entire process.
When inspectors see food and beverage organizations using an EQMS to manage their quality processes across all facilities and their supplier networks, they know they are reviewing a single version of the truth and that the company is in compliance with regulatory requirements.
Kuchinski, the industry solution director at Sparta Systems, has 20 years of product management and marketing experience with a focus on consumer packaged goods, chemicals, life sciences, and technology. She has an MBA from LaSalle University and Six Sigma Green Belt certification. Reach her at email@example.com.
References Furnished Upon Request