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  - April 10, 2013 -  

Supply Chain News: What's Really Happening with the Food Safety Modernization Act?

Expert Panel Details What Has and Has Not Happened, What Leaders are Already Doing

  by SCDigest Editorial Staff  

Many people, especially consultants and technology vendors, have been throwing out worries about looming requirements for food manufacturers and distributors from the Food Safety Modernization Act signed into law in 2011.

But details are often vague at best. What is really in the law, and what if any regulations have been put in place? What is the timeline going to be for additional rules?

SCDigest Says:

The law also bars the FDA from mandating a specific technology such as perhaps RFID to be used in collecting any required data.

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SCDigest tackled all these questions and more in a recent Videocast on our Supply Chain Television Channel with an expert panel on the subject that included:

Jennifer McEntire, Senior Director – Food and Import Safety, for consulting and research firm Leavitt Partners

Jeanne Iglesias, Senior Director, Industry Affairs & Collaboration, at the Grocery Manufacturers Association (GMA)

Tom Kozenski, Vice President of Product Strategy at JDA Software

McEntire is well into the details of the law and what has and has not happened with regard to actual regulations. She started off by noting the basic concept that the purpose of traceability in the food supply chain is to be able to recall any food that could pose a danger to the public as quickly as possible. The better the food can be tracked, the faster and easier that recall becomes.

The 2002 Bioterrorism Act led to regulations in 2005 from the FDA promulgating in part the "one up, one back" rule, under which companies have to document who they received food products from and who if anyone they then ship those products to.

The 2011 FSMA act could – but has not really as yet – require much higher standards of traceability, McEntire said. Only two specific rules have thus far been proposed by the FDA - one involving preventive control procedures and the other on produce safety – and though both will require additional record keeping, neither involves enhanced traceability.

But there is possibly a lot more to come. FSMA required the FDA to conduct a series of pilots related to traceability, looking at what processes and technologies could and should be deployed to improve visibility and control of the food supply chain.

Those tests were completed in mid-2012 under McEntire's leadership, and after several months of delay, the report has just recently been released. We will have details on the findings shortly in SCDigest. While traceability requirements potentially could ultimately come out of those test results, there is nothing in place from rules perspective yet from the FDA.

McEntire said another key element of FSMA is that any increased traceability requirements must be limited to what the law calls "high risk foods," presumably meant to refer to foods with a history of frequent issues or ones that might or have cause serious illness or death.

What foods will be placed into that high risk category? No one knows at this point, McEntire said, and neither whether the number will be a few or a lot. Later in the QA session, she also noted that it wasn't clear if say a potentially high risk food like tomatoes might then lead to other products that use tomatoes also being considered high risk. If the answer turns out to be Yes, that would pull a lot more products and companies into the enhanced food traceability requirements.

"FSMA did not give the FDA the authority to change food traceability requirements across the board," McEntire said.

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The FDA was supposed to release the initial list of high risk foods in January of 2013 but has so far failed to do so, McEntire said.

Further, the law, somewhat strangely from our view, says the FDA cannot require a full "pedigree" of a food product, meaning a full record of the product as it moved through the supply chain from origin to final consumer.

The law also bars the FDA from mandating a specific technology – such as perhaps RFID – to be used in collecting any required data.





Videocast Resources


Exploring the Current Food Safety Environment


Videocast Slides


Podcast of the Excellent QA Session

The FDA was also required under the law to issue a report to Congress in July of last year, based in part on the pilot test last summer, but that also hasn't happened. Neither has the requirement for proposed rules on traceability that the law required to be issues by January of this year. McEntire does not expect the proposed rules to be issued any time soon.

"This does not mean the industry gets a pass for the short term or the long term," McEntire said. "Industry should certainly keep working on traceability, understand traceability, because even if the FDA doesn't come at you with a big stick, it is likely your supply chain partners will."

GMA's Iglesias noted in her presentation that many food companies were already working to put capabilities in place for track and trace that go far beyond the current and even likely future FDA regulations, in the name of consumer safety and brand protection. But, she noted that there was a wide range of approaches by GMA members, from those being very proactive and going beyond regulatory requirements to those mostly waiting to see what the new rules will be.

JDA's Kozenski said he has seen the same wide variance in approach to the issue, but emphasized that many in the industry are seeing a strong ROI from their investments in food traceability. For example, he cited one company that is using JDA technology such that they have complete visibility and control of product as it moves out from factories to co-packers and distribution points.

That capability enabled the company to use the transit time as part of the QA hold period. If QA testing finds a problem, the JDA software will "freeze" the product at those sites, sending the affected product to quarantine upon receipt and preventing any of it from being shipped, using in part a web application that co-packers can access.

This capability enables the company to shave 1-3 days of inventory from safety stock requirements, Kozenski said.

At the resource section nearby, you can view an on-demand version of the broadcast, access the excellent slides, or download a podcast of the QA session.

Do you have any additional thoughts to offer on what is happening with FSMA? Let us know your thoughts at the Feedback section (web form) or button (email) below.

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