FSMA requirements for small to mid-sized businesses clarified
PMMI’s FSMA consultant dishes out advice to companies that might be lagging in compliance
The Food Safety Modernization Act’s preventative controls rule went into effect this past fall for large CPG food and beverage companies. Most in the industry understand the new rules are focused on prevention of food safety hazards, but that doesn’t mean everyone is at the same level of comprehension and compliance.
According to PMMI’s 2016 Food Safety Modernization Act Update Report, food and beverage companies are still struggling with understanding the requirements, determining the rules’ relevance to them, knowing the deadlines, and obtaining and managing the increased amount of documentation needed.
The report also finds those who will be most affected by FSMA are: fresh fruit and vegetable companies, small companies and farms, and food companies sourcing ingredients from foreign-based suppliers.
We asked Jeffery Barach, FSMA consultant to PMMI, to answer a few of our questions to help clarify the rules:
FE: This is the year small to mid-sized food and beverage companies will need to be in compliance with the preventative controls of the FSMA rule. How prepared are these companies? What are some of their biggest challenges? What should they be doing now?
Barach: For small and medium-sized processors (companies with 500 employees or less), meeting the requirements presents more obstacles due to limited resources and lack of in-house expertise. To comply with provisions of FSMA, many food processors are making upgrades and even refurbishing their manufacturing supply chains from scratch in order to meet new standards for anticipating and preventing contamination and recall issues. The more thorough their plans to anticipate, prevent and, if necessary, execute a recall, the less likely it is that a food safety issue will present threats to consumer health and harm a brand’s integrity.
Moving forward, food and beverage manufacturers must execute best practices in sanitation, temperature control, cleanliness and record keeping more than ever before. Negligence in any of these steps can result in serious threats to food safety. For guidance on FSMA implementation and documentation, PMMI has developed the Food Safety Modernization Act Update Report.
FSMA may have provided some initial burdens for food and beverage companies. Ultimately, however, manufacturers will see the benefits in complying with these preventive control rules as a means of ensuring a safe supply chain that minimizes risks to their brands.
FE: It’s been almost half of a year since large food and beverage processors had to be in compliance with the preventative controls rule, but we haven’t really seen any huge shutdowns. Was that because those companies were well prepared or has it been an enforcement issue? Do we have a sense of how the enforcement period is being implemented or unfolding?
Barach: The big companies have had voluntary Hazard Analysis and Critical Control Point (HACCP) programs in place for several years, and this gives them a strong base for an easy transition to FSMA preventive controls. Unfortunately, smaller companies that have only had current Good Manufacturing Practices (cGMPs) may not have fully migrated to a HACCP approach. Therefore, these smaller companies have bigger challenges and are not as well prepared as bigger companies. Also, many small companies are resource-challenged making their job extra difficult.
Moreover, because of FDA’s limited resources, the FDA will use a risk-based inspection approach. It will look at companies that have had past problems and focus on them. As a result, big companies doing everything right won't be a priority for inspection to determine compliance. So far, we have heard very little about non-compliance of big companies. This may change when the FDA begins looking at the small and medium sized players beginning this fall.
FE: With the new administration, will there be any changes to FSMA?
Barach: When a new administration moves in, many of the previous people at the higher levels move out. However, you don’t see so much change at the field level, and I don’t foresee significant changes, if any—only continued reinforcement of the law.
FE: Looking past preventative controls compliance, what is the next big concern for food companies preparing to be FSMA compliant? And how should they be preparing for this?
Barach: Food and beverage manufacturers are not the only ones facing challenges. FDA inspectors must be up-to-speed with FSMA regulations as they inspect FDA regulated facilities. Still, the number of unannounced visits to inspect facilities is expected to increase and companies must be ready to present their food safety plan when it happens.
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