Collaborative Efforts Align USDA and FDA: Can They Be Taken Even Further?
Updated: Nov 22, 2018
I have been an advocate for a Single Food Safety Agency for years and this issue may be coming up again under the current administration. The challenges and inefficiencies of having two separate departments overseeing food in the U.S. and the need to streamline the regulations of FDA and USDA are topics that tend to come up in discussion every time a major rule or standard is introduced. And with the recent announcement from the agencies, it’s likely to arise again … but this time it is the regulatory bodies themselves which have taken positive action to streamline requirements.
On June 5, FDA and USDA announced their new collaborative effort to streamline produce safety requirements for farmers by aligning the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of FDA’s FSMA Produce Safety Rule (PSR). The purpose is to ensure a better understanding of and compliance with produce safety standards by produce farmers; it follows the signing of a formal agreement earlier this year that outlined plans to increase interagency coordination.
The produce segment became a focus for interagency coordination because the first of the key compliance dates for the PSR came due for large farms in January 2018, although FDA will not begin compliance inspections until spring 2019 (except for sprouts). But while farmers prepare for these inspections, they also face requirements from most produce buyers to meet market access standards, which can be met by USDA H-GAP audits. Having alignment between that audit and the PSR enables farms to demonstrate compliance with both regulatory and buyer requirements. USDA audits will not replace FDA inspections, however. At least not yet but I speculate that may happen at some point in the future.
As already noted, I have often said that I am completely in favor of a single food safety agency, though I don’t know that we will evolve that far anytime soon. But like the USDA’s actions to harmonize its standards with GFSI discussed in last week’s newsletter, I see this as a very positive step in that direction.
But I also think that even with this new alignment, we are missing a very significant factor in produce safety – and general food safety. That is the setting of requirements or regulations for traceback – beyond one forward/one back. In thinking about this, my mind wandered back to the Produce Traceability Initiative (PTI) which we also discussed in a recent newsletter. Whatever happened to that? Is it being used in the produce industry? Is it working the way it was intended? How many are using the PTI? What are the challenges to PTI? Can it be adapted to other food? Should it, or a similar program, be required of the entire food industry?
The timing of my questions was, in fact, quite serendipitous, as it coincided with an article published in The Packerjust last week in which a number of industry leaders were asked similar questions. One of those cited was FDA Deputy Commissioner for Foods Stephen Ostroff. While noting that he did see that PTI labels made it easier for FDA to reconstruct supply chains in investigating outbreaks, complete and quick traceback is directly dependent on the availability of information and its ease of access. And PTI, “I think helps to address that,” he said. But, he added, “The degree to which it’s been adopted and is actually being used, I think, is the critical issue in terms of how helpful it is in terms of doing tracing.”
I find it interesting that Ostroff only “thinks” this helps? Perhaps it is just political rhetoric so as to not make too strong a statement toward any particular initiative? But there’s really no question that adoption and use of a traceability system – be it PTI or any other system – is critical to its ability to be helpful in tracing. If it’s not adopted or used, it doesn’t trace. And that is exactly the problem. There is no requirement for traceability to the source, let alone one that enables ease of access.
So even while the article cites Walmart, PMA, United Fresh, and others all advocating for PTI – which is great – Is this enough? FDA has the authority to beef up one forward/one back for high risk foods, and I urge them to get moving on that. But FDA doesn’t expressly have the authority for full pedigree traceback. In terms of rapid identification of risks, it would be great to have expanded traceability – beyond one forward/one back.
Or, perhaps, once again, it will be the end consumer who really drives it; so that, as Walmart’s Vice President of Food Safety Frank Yiannas was cited as saying, “It won’t be just a 'nice to have,' it’ll be a requirement to have, and you’ll be able to do (traceback) in seconds. Consumers are expecting it, demanding it, they want to know more about their food, where it came from.” It would not be the first time that major retailers drive change in the food industry.
And, advocating his closing comments which, in fact, echo the essence of many statements I’ve made myself, I would agree that, with the romaine lettuce outbreak, regulators will (or should!) be more interested in rapid traceback, and I, too, “would encourage them to do it and to do it now.” Perhaps this could be the next collaborative effort of USDA and FDA? But better yet a three-way collaboration between USDA, FDA, and the produce industry.
About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG's team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com