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In 2011 the FDA Food Safety Modernization Act (FSMA) was signed into law and started to be implemented in September of 2016.We looked at the recall statistics during similar periods in 2016 and 2017.  As in previous years, allergens and microbial contamination lead the reasons for recalls in both years. The early data does not show a significant impact of the new FSMA rules on recalls due to allergens. The total recalls due to microbial contamination were 60% higher in 2016 as compared to 2017. Could it be a result of the new FSMA regulations?

Original Believe of the Impact of FSMA

On January 4, of 2011 The FDA Food Safety Modernization Act (FSMA) was signed by President Obama. FSMA is believed to be the most far-reaching reform in food safety.  FDA Commissioner Margaret Hamburg, M.D., posted a blog on the meaning of the new law.

The profound changes mentioned Included:

  • Preventing illnesses, rather than reacting to them. Food producers and processors are bearing the primary responsibility to illnesses prevention.
  • The law gives the FDA new legal power making sure companies are meeting their duty to prevent illnesses rather removing the food from the market after the fact.
  • Creating a risk-based system of food safety.
  • Assuring that importers of food use the same food safety rules as domestic manufacturers.

After a long preparation period, last September (2016), the first FSMA implementation step took effect, when companies having 500 + full-time employees had to comply with Preventive Control Rules.  Smaller companies will have another year or two to comply.

Comparison of FDA recall data 2016 (Jan-Sep) and the same months in 2017

In both periods the two major reasons for the FDA recalls were due to microbial contamination and undeclared allergens.  Most microbiological recalls are due to Listeria monocytogenes and Salmonella. Most undeclared allergens recall due to not declaring allergens on the product label.

Allergens have persisted as a leading reason for food recalls due to the implementation of labeling rules in the United States and Canada, which leads to greater regulatory scrutiny and enforcement. As can seem from the figure below, the number of recalls due to allergens was quite similar in 2016, and both were lower than the recalls due to microbial contamination. The early data does not show a significant impact of the new FSMA rules on recalls due to allergens.

The total recalls due to microbial contamination were 60% higher in 2016 as compared to 2017. It could be as a result of the new FSMA regulations that were put into place. However, almost all the difference is due to two large spikes in LM recalls in April-June of 2016. These recalls are a result of many recalls associated with SunOpta, a Canadian company that on May 4, 2016, recalled sunflower kernel products that had the potential to be contaminated with Listeria monocytogenes.

The roasted sunflower kernel products were sold directly to customers and distributed to other manufacturers, including Quaker Oats, Planters and Clif Bar brands, PepsiCo, tree House, Atkins, Kashi, Hershey, Quaker, and many more companies.  It resulted in almost 50 recalls in April-May 2106. Adjusting the numbers of recalls excluding the SunOpta recalls making the two periods quite similar.

The Ripple Effect

In recent years, several cases of large-scale recalls have been linked to a single ingredient supplied to countless number of manufacturers.  In some cases, recall from a supplier to the industry causes a primary recall, followed by a secondary report and even a tertiary recalls. This happened 2017 due to powdered milk and buttermilk powder produced by Valley Milk Products (VMP). As we reported in January 2017, five months after the U.S. Marshals Service raided a powdered milk factory at the request of FDA, many companies were drawn into the Salmonella recall linked to milk powder and buttermilk produced by Valley Milk Products (VMP).

The Valley Milk Products recall resulted in a subsequent ripple effect of recalls affecting over 30 companies. Secondary recalls included companies such as Twinkies, Palmer candy, Herr Foods, Dawn Food Products, House- Autry, Dieffenbach’s,  Mikesell’s  and Route 11potato chips, Tupperware  Southwest Chipotle Seasoning, Stonewall Kitchen Cinnamon Apple, Orange Cranberry and Toasted Coconut and Pancake & Waffle Mixes and many more. The tertiary Effect included companies that used products of the secondary group of products.

However, some of these large recalls have yet to cause a single illness. The products are pulled off the shelves solely as preventive measures. This shows that most of the recalls were preventative and not necessarily as a result of the presence of dangerous organisms.

How do we Measure Success of FSMA?

FSMA is all about prevention and should transform the US system to a system that will prevent or significantly reduce foodborne illnesses. Therefore, FSMA success should result in a reduction in foodborne illnesses. However, it is too early to access success using this measure.  A reduction in the number of recalls might not be the best indicator of success.

Many of the FSMA activities that are being established, initially causes an increase in pathogens finding.  The more one looks for pathogens, including testing the environment extensively, the more one is likely to find them. Therefore, the decline in recalls is somewhat surprising.

It is very important to establish measuring systems that will allow us to access the true economic and safety impact of these new regulations.

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