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FSMA: Common FSMA Myths & Gaps

Posted on February 1, 2017 by Jennifer Kinion

Our first FSMA Fridays session of the year with The Acheson Group focused on common myths and gaps in FSMA compliance. Joining us as co-presenters were Dr. Peyman Fatemi, Vice President of Scientific Affairs and Christopher Snabes, Senior Manager, Food Safety. If you missed our January session, our presenters had some interesting insights to share on this topic.

FSMA Rules Compliance

There are commonalities in the gaps within FSMA that the Acheson Group encounters while working with companies. Some of these gaps include a tendency to underestimate the complexity of developing a FSMA plan, questions surrounding which rules apply to a particular company’s situation, and the lack of access to qualified people in rural areas for FSMA expertise.

Here are some of the common myths about FSMA rules compliance that were discussed in the webinar:

Myth: “I have plenty of time.”

Myth: “I am foreign facility, so the rules do not apply to me.”

Peyman points out, “You do need really need to get started very early, because you will undoubtedly realize that there are areas that require more time and are more complex and need resources to change and modify to become FSMA compliant.”

He further elaborated that foreign facilities that import into the U.S. will be subject to foreign supply verification program, so essentially if you're managing risk or hazards, then you will be subject to rules.

Myth: “The FDA inspector knows more about the food safety and the rules than I do.”

Peyman disputes this notion, indicating that the inspectors are also identifying their own gaps in knowledge and are trying to get themselves educated and up to speed on FSMA in parallel with food companies.

“…Our expectation is, and what we're seeing, is that they going through the same level of training and education as everybody else in the industry. Maybe some of them may have more experience and that's great, but others are going to try to feel their way through it like everybody else…”

Food Safety Plans

Christopher Snabes delved into the topic of gaps in food safety plans, which can include failure to consider all related biological, chemical, and physical hazards, processes not being properly validated, lack of funding or management support to implement necessary changes, and lack of understanding and knowledge of the science behind a food safety plan. Often, a food safety plan also lacks a process narrative to tie all of the elements of the plan together with a description of the company and their products. Some common myths pertaining to food safety plans, including the following:

Myth: “My HACCP Plan covers everything.”

Myth: “I just developed a food safety plan. My job is done.”

Christopher dispels these myths, going on to say, “HACCP is not HARPC, it's not FSMA equivalent. It's a great start, and it covers many of the areas that FSMA requires, but it's not complete. HACCP doesn't address the phrases of preventive control, for example.” For companies that operate under the assumption that their work is done after developing a food safety plan, he also pointed out, “…They don't realize that it takes time and money to continually maintain and monitor the food safety plan. If ever there's a change in the process or the building, facility, physical structure, they have to reanalyze the food safety plan. Just because you have it written, that doesn't mean it's done. It only means it's just the beginning.”

Myth: “My GFSI certification is sufficient.”

Not true, according to Christopher. He continues,”The GFSI plans and schemes are very close to what FSMA requires, but they are not equivalent…just because you're GFSI compliant does not mean your food safety plan is complete according to FSMA.“


Sanitation was discussed as an area of FSMA compliance where gaps are prevalent, including practices where sanitation is driven by production schedule rather than risk of microbial build up, and sanitation practices that fail to account for the age of the equipment and the facility. In some facilities, equipment is not designed according to sanitary design principles, and as a result, is difficult to clean.

Myth: “My sanitation chemicals have always been effective.”

Myth: “My ATP swab sampling results are low, so I have no microbial issue.”

To dispel these myths, Christopher pointed out that while facilities believe that their chemicals are effective, they may have no procedures in place to measure efficacy. Do they make up a batch once a week, and use it all week long? If they use it during the sanitation process, do they monitor the concentration and dilution during use? Regarding ATP swab sampling, he goes on to assert that while you might have a low count, the low count might be a food pathogen.

Environmental Monitoring Programs

Peyman addressed numerous gaps around environmental monitoring programs (EMP), including the problem of facilities that don’t take a serious “seek and destroy” mentality with respect to taking proper corrective actions. He asserted that vector swabbing is insufficient and that doing so does not close the chapter on investigation, as the facilities may encounter a recurring issue. While a company may be collecting data to support their EMP, often there is insufficient data analysis.

Some common myths around EMPs include:

Myth: “I haven’t had a positive in 2 years, so I am safe.”

Myth: “I have to perform Whole Genome Sequencing.”

Regarding positives, Peyman asserts that even though you have not had positives within your EMP, when you view the facility as a whole and see issues with personnel traffic management from the raw to the finished side and observe weaknesses in the equipment design, the facility design, or control of the process, it brings into question whether your practices target the right areas. On the topic of Whole Genome Sequencing (WGS), he states, “If you're repeatedly finding an organism after you have tried to take corrective action, that may be an approach you want to take but it's not something you have to do.” He further elaborates, “You have to take a lot more into consideration in terms of new exposure, potential expansion of the recall, because if you find an organism that has links with something you found two years ago, then you have an entire two years of production under question. So, the question is, how well are you managing your results? How well are you managing the corrective actions with cause analysis to avoid having to go down the road of whole genome sequencing?”

And There’s More!

Access the full session recording to hear more of our presenters’ perspectives on myths and gaps in FSMA compliance as well as their insights the upcoming compliance date for the Sanitary Transport Rule and other FDA guidance.

Need help ensuring FSMA Compliance?

The TAG team can help you identify gaps and update your food safety and recall plans. For more information visit www.achesongroup.com.

Interested in learning how SafetyChain’s solutions are helping our customers reduce risk, control costs and ensure regulatory, non-regulatory and customer compliance? Learn more at www.safetychain.com/solutions.

FSMA Fridays in 2017!

Be sure to save the date for our next FSMA Friday session, Friday, February 24. Not part of FSMA Fridays? Sign up today at https://safetychain.com/resources/fsma-fridays/.

Topics: Safety, Quality