FSMA, One Year Later: Top 5 Things We’ve Learned

By Erika Miller

January 18, 2017

Categories: Compliance, Food Manufacturing, FSMA, RC - Food Safety Training

Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.

5. Don’t Scrap Your Current Plan

Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.

4. Education Is Key

A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).

3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”

Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.

2. An Ounce of Prevention is Worth a Pound of Cure

The entire purpose of FSMA is to shift the focus of food safety from reactive to proactive. Historically, the safest products to buy were those from companies with recent major recalls, as every process at the company is under a microscope for some time after such an unfortunate event. However, that’s really an unsafe way to play, and tells you more about what the United States didn’t have before, in terms of regulatory presence and capability. By shifting focus to prevention rather than detection after the fact, we engage the core tenet of HACCP in its most basic form. There are decades of data to demonstrate that prevention works, and the proliferation of HACCP-based systems in companies around the globe, even those that lie outside the food sector, shows it is a workable way of preventing issues.

1. Attitude Is Everything

There has been a very combative relationship between FDA regulators and industry in many sectors, with each feeling the other side is aggressive and unnecessarily difficult. I can say from personal experience that the FDA regulators I have met through our public PCQI workshops put their pants on one leg at a time. They are people too, and approaching a potentially hostile facility must be nerve-wracking. Treat them with respect, engage the golden rule and all interactions can be as amicable as possible (if not completely painless!). The FDA is doing their part to promote a more open system of communication by sending their inspectors to public PCQI classes, holding webinars and other training sessions, and introducing tools like the Technical Assistance Network to help individuals who have questions about the regulations. We must meet them halfway, give the benefit of the doubt and remember that you catch more flies with honey than with vinegar, after all!

Of course, we learned so much more than just these five things. The intricacies of the regulation, the ways that FDA will use their new authority, the plans for spreading the word to the smaller processors who don’t even know what FSMA is yet—these are all challenges for the new year, and we await them eagerly. We must continue to build on the foundation we have set and move forward in the New Year with a focus on prevention, objective evidence and education.

About The Author

Erika Miller

Food Safety Specialist

D. L. Newslow & Associates, Inc.

Erika Miller has 10 years’ experience in the restaurant business, both front and back of house, where she worked her way up from washing dishes to waitressing. She learned the concept of food safety at a Servsafe food handling course during this time. Throughout her college career, she worked in several foodservice establishments. This experience has taught her the challenge and necessity of maintaining a safe food handling culture during times of peak production. Miller has experience as a quality assurance manager, as well as an analytical chemist. She understands the advanced instrumental analysis methods, such as gas chromatography and mass spectrometry, as well as microbiological testing methods commonly employed within the industry. She has an understanding of organic chemistry and takes a fact-based, scientific approach to system development and implementation.

Miller received her Bachelor of Science degree in chemistry from the University of Florida. A Tampa native, she is trained in and experienced with GMPs, HACCP, FSSC 22000, Internal Auditing/Risk Analysis and FSMA; including program design and implementation, facility compliance, and training. After a brief stint in aggregate quality assurance where she learned the basics of ISO and developed her first SOP manual, she entered the Florida Citrus industry (on the byproducts side), where she received further extensive training in the citrus industry. She has completed the FDA/FSPCA Preventive Controls Qualified Individual (PCQI) course. Miller has the unique ability to understand the scope of an operation and is able to logically develop a Food Safety Management System in a non-traditional food handling facility.