The Latest in Food & Flavors Regulatory Landscape: A Recap of the FDA’s FSMA Meeting and Food Safety Summit

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May 5, 2015Bernard HennBlog

Over the last two weeks, I’ve had the privilege of attending two prestigious industry conferences, including the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) public meeting in Washington D.C. on April 23-24, 2015 and The 17th Annual Food Safety Summit held April 27-30 at the Baltimore Convention Center.

The FDA FSMA public meeting in Washington DC drew representatives from all sectors of the food and feed industries, and their supply chains. The purpose of the meeting was for FDA to outline its ideas for strategic implementation of FSMA, and obtain feedback and input from stakeholders. In addition to presentations from FDA staff, the meeting included a number of lively breakout sessions during which attendees were invited to give their candid thoughts on aspects of the implementation of FSMA, including preventive controls, produce safety, the foreign supplier verification program, third party auditor certification and intentional adulteration. Leading up to the meeting the press addressed the funding gap FDA seeks.

FDA has signaled a culture change that will see it move from “reactive” to “preventative.” The fine details of exactly how FSMA will impact food producers, manufacturers, and others in the human food and animal food and feed supply chains, remains to be seen once a number of pending final rules have been published.  However, what is certain is that FSMA is bringing sweeping changes to the human food and animal food and feed industries, and the way in which food safety is regulated. This will have implications not only for producers and manufacturers across the U.S., but is also likely to have major impacts on importers of food and their foreign suppliers.

FDA is taking comments to the docket on FSMA through May 26, 2015.

Moving over to the Food Safety Summit at the convention center in Baltimore, Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine started the meeting by indicating that the FDA was in alignment on the goals of FSMA and creative thinking was the new norm at FDA and for the industry when it came to food safety systems.

Some of the risks to the industry were exposed at the summit, including the fact that undeclared allergens account for 43% or more of all food recalls.  Allergen adulterations are a supply chain issue of several supplier tier levels. Food borne illnesses are the main motivators for FDA Food Safety Modernization Act (FSMA). Root cause analysis seems to be the solution including whole genome sequencing being used on the recent ice cream recall. Testing is not possible for everything but lacking validated documentation can indicate where random testing should be applied first as a high risk.  In addition, having updated global regulatory content can aid in any automation of a food safety risk assessment.

The industry is required to do risk analysis by FSMA. Some are further than others in the implementation of Global Food Safety Initiative (GFSI) concepts expected to be finalized between August 2015 and March 2016.

Undeclared allergens are also a big issue for the industry for another reason. For example, at the food fraud session on Wednesday afternoon, food fraud from the substitution of ingredients was addressed as a key food safety issue, because the added ingredients may contain allergens.  As criminals become more sophisticated, testing cannot keep up and risk assessment must be undertaken based on intelligence. Again, information must be gathered and supplier engagement is key. Supplier documentation is required in addition to testing and supplier assessment.

FSMA was discussed several times at the Food Safety Summit and it was confirmed that the new import controls and foreign supplier verification program will be a huge challenge both for industry and FDA.     

In general the summit included professionals from around the world discussing the most pressing issues facing the food industry including Food Fraud, the Food Safety Modernization Act, and the Integration of the Nation's Food Safety Systems.

Major leaders in the industry including FDA's Mike Taylor, USDA's Al Amanza, AFDO's Joe Corby, CDC's Chris Braden and senior operations executives from Chiquita Brands, Hormel Brands and The Cheesecake Factory shared their insights on departmental cooperation with determined industry professionals who attended and benefited from this important event.

A few of the highlights from the conference program included a Two Part Food Fraud Session with international speakers from the China National Center for Food Safety Risk Assessment, the European Commission, and Queen’s University Belfast who focused on Food Fraud trends beyond the US, and provided insight on related industry, legal, and regulatory activities. A five part series on FSMA that focused on how the industry and regulatory agencies will implement the new rules and mandates of the Food Safety Modernization Act (FSMA) and focused on the implementation of FSMA, the Produce Rule, the Preventive Controls Rule, the Imports Rules, and the Intentional Adulteration Rule.

The Outbreak Investigation Session ­– which looked at the role of the foodborne disease outbreak investigation that took place at the 2014 Summit ­– provided attendees an opportunity to discuss some of the most pressing issues facing the industry including leadership, local sourcing, food safety systems, the PCA case and more. 

Plans are already being made for the 2016 Food Safety Summit which will be held for the first time in Chicago from Tuesday, May 10 through Thursday, May 12, 2016 at the Donald E. Stephens Convention Center in Rosemont, IL. We’re looking forward to another thought-provoking and informative conference next year!

In the meantime, if you are struggling to meet your compliance obligations, 3E Company provides a central source of comprehensive and accurate compliance content solutions and services that can be easily managed and integrated into a food and flavor manufacturer's business processes. For more information, please feel free to reach out to me directly at – I’m happy to help!

Bernie Henn is the 3ESC Business Development Manager at 3E Company, responsible for developing industry-specific associations, managing existing partnerships and working closely with product management to enhance and strengthen 3ESC’s position in the marketplace.
He brings marketing, sales, regulatory and technical experience from General Electric, Teknor Color, LyondellBasell (formerly Quantum Chemical) and Rohm and Dow Chemical (formerly Haas). Mr. Henn has a B.S. in Plastics Engineering from Case Western Reserve University in Cleveland, OH and an MBA from Xavier University in Cincinnati.