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From: The eUpdate, 4.16.13

Food & Beverage Manufactures Still Unsure Regarding FSMA Guidelines

Survey provides insights into how manufacturers are handling government expectations

by Sudhakar Kaup, CTO

The Food Safety Modernization Act (FSMA) was signed into law two years ago, however most food and beverage regulations were just released this past January. A new study by iRely, a solution provider for food and beverage manufacturers, has found that while the guidelines have been pending for some time, many process manufacturers are still either uncertain or unaware of how the new regulations will affect their production processes.

According to the survey, an overwhelming majority of respondents (71 percent) agreed that the new FSMA regulations would affect their operations, but about 47 percent were “unsure” as to which requirement would affect them the most. In addition, about 44 percent of respondents listed “uncertain or unclear implementations” as their biggest concern about new FSMA rules. In short, how are companies supposed to follow regulations they don’t understand?

While food and beverage manufacturing leaders seem to be mostly aware there are new requirements, they are still trying to figure out how exactly those requirements will serve as a motivator for operational changes. The survey also found that a large number of manufacturers are either unconcerned or unaware of how the new regulations directly correlate to the safety and quality end products.

The FDA has made it clear that most plants will need to increase capital expenditures in order to upgrade technology and meet new regulations. Ironically though, when asked if the new FSMA rules affected their ability to plan/budget, about 45 percent of respondents answered no, they have not acknowledged FSMA guidelines.

In fact, most don’t plan to increase resources at all. Seventy-six percent of respondents said they’re not looking to increase their resources or employees simply to meet FSMA requirements.

This is a concern considering the FSMA is requiring additional safety protocols from manufacturers. Mock recalls, for example, will need to be conducted more often. In most cases, these mock recalls can take days or weeks to complete and requires the participation of staff from various departments. But in order to complete the mock recalls, an increase in resources would likely be required. The new regulations also give the FDA power to assess fees and fines. If companies fail to respond to a mandated recall or conduct them regularly, a company’s registration, without a court order, could be suspended.

The FDA has already flexed its new-found authority—making an example of Sunland Inc.’s New Mexico plant. The operation was shut down November 2012 because they failed to comply.

The lesson: Companies should utilize new adaptable manufacturing systems. With these upgradable systems, not only will they be protected from immediate threats, they will also be prepared for new, possibly stricter, FDA regulations in the future.

But the truth is many plants still rely on basic ERP systems or spreadsheets to track and manage production processes. Forty-five percent of survey respondents reported using spreadsheets or manual processes to manage traceability, quality, and inventory issues. This basic technology has gotten the job done in the past but FSMA regulations state clearly the need for improvement in electronic record keeping and auditing, which requires more up-to-date technologies in order to properly track and report all necessary items.

Part of the hesitancy to upgrade plant-tracking technology is likely centered around slim margin and the still recovering economy. Generally, companies have chosen to hold more cash since factors like unemployment have caused the economy to fluctuate. Today’s investments are directly related to revenue improving and cutting costs only.

Furthermore, companies are skeptical as to whether or not these FSMA-related improvements will actually be enforced. But plant owners should know that the Congressional Budget Office has allotted $280 million per year for enforcement of these regulations.

Still, 76 percent of respondents said they would not start using an automated system now because their current system is already efficient.

The results of the survey seem to show that the FDA and government need to do a better job of educating and enforcing the rules of the FSMA. However, facilities managers have a responsibility as well. It is their duty to have better tracking and tracing technology—allowing them to meet and pass FDA recalls or audits, as well as providing customers with the assurance that their food and/or beverages face no contamination threats throughout the production process.

If for no other reason, one of the most convincing reasons to submit to new FSMA regulations is to avoid complications in court. When rules and guidelines are loosely defined, the chances of winning a case against a manufacturer are pretty slim. But once rules are clearly laid out, as they have been under the new FSMA guidelines, lawyers are more willing to take the case because they can more easily identify any incorrect interpretation the manufacturer might have made and analyze every aspect of the regulations.

Kaup (CPIM) is the chief technology officer at iRely, LLC, a provider of process manufacturing and commodities software. He has over 18 years of experience in designing and implementing solutions for the manufacturing industry. Reach him at



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