In an Op-Ed published by Politico today, former FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor is calling on FDA’s Food Program to be separated from the current hierarchy—with the establishment of a new agency that has its own head and reports directly to the HHS secretary.
“Under FDA’s current structure, no one is really in charge and realistically accountable for the food program’s strategic direction, sound resource management and overall success; and this state of play has real consequences for consumers. It puts at risk the public’s health and consumer confidence in the nation’s food supply,” Taylor wrote in “It’s Time to Fix FDA by Breaking It Up”. He emphasizes that food has not been given a high enough priority at the agency, despite the passage and implementation of FSMA, and the past two administrations did not help either. “Neither the Obama nor Trump administration empowered the deputy commissioner for food to oversee the program’s largest organizational unit, which is responsible for food inspection and import activities and manages nearly 70% of all the dollars Congress gives the food program,” he stated. “The success of food safety modernization won’t succeed without the policymaking and inspection units working as an integrated whole. Because they are all managed separately and report directly to commissioners whose attention is elsewhere, this is virtually impossible in today’s FDA.”
Allowing the Food Program to stand on its own, reporting directly to HHS, would create an agency that is empowered not only with more resources but also with having more accountability.
With FDA’s limited resources, it’s important for the agency to work smarter, not necessarily harder, when it comes to implementing FSMA. During an FDA Town Hall at the Food Safety Consortium last fall, Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, briefly touched on the agency’s strategy for working with foreign parties to ensure compliance related to importing foods into the United States, including the Food Safety Systems Recognition Agreement with New Zealand.
One of the industry concerns related to FSMA implementation surrounds the change in approach required of FDA investigators—from a resolutions approach to a systematic method of assessing systems and facilities. During an FDA Town Hall at the Food Safety Consortium, Michael Taylor, deputy commissioner for foods and veterinary medicine at the agency explained that he was initially concerned about this shift, but is now pleased with the enthusiasm he sees among FDA investigators. “They’re part of a public health force that is out there empowered and supported in the verifying the systems… as opposed to the historic role of collecting evidence [and] going back to the office…” he said.
We honored Nancy Donley, former STOP spokesperson with the Legacy Tribute award. Since the death of her son Alex, in 1993, Nancy has selflessly advocated for stronger food safety policies and practices. Our other esteemed guest was Frank Yiannas, vice president of food safety for Walmart, a man known for passionately escalating the notion of a “food safety culture.” Frank received STOP’s Industry Advocate Hero award.
Another highly regarded guest, FDA Deputy Commissioner Michael Taylor, shared his reflections on the magnitude of the evening. Please take a moment to read Taylor’s eloquent and thoughtful words regarding this milestone celebration.
Part II of Michael Taylor’s speech at the Food Safety Consortium gets into what’s at stake as the implementation stage of FSMA begins. “We’re regulating areas we haven’t regulated before,” said Watch Part I of Michael Taylor’s speech HERETaylor, as he acknowledged the work FDA has been doing with produce growers and the enforceable standards that will now be present on farms. He also indicated the challenges ahead in regulating imports and managing the supply chain—more than 150 countries send food products to the United States, and this continues to grow rapidly.
“We see the import aspect of implementation perhaps being the most daunting in the sense that it’s really requiring us to work in completely new ways with foreign partners, with the import community, and a whole new robust toolkit…that needs to be used in a strategic new way,” said Taylor.
Four years in the making and the FSMA implementation journey has begun. Michael Taylor, deputy commissioner for Watch Part II of Taylor’s speechfoods and veterinary medicine at FDA, describes, from a high-level perspective, what lies ahead in his first public speech since five of the seven rules were finalized. The following video is Part I of Taylor’s speech at the 2015 Food Safety Consortium conference.
FSMA isn’t about zero risk but rather minimizing the hazards, said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine at the opening of the Food Safety Consortium conference yesterday. “We have hundreds of thousands of businesses that are subjected to something that they weren’t before,” said Taylor. “The reality is, we’re still going to have outbreaks this year and the next year.”
In his first public speech since three final FSMA rules (on produce safety, foreign supplier verification, and accredited third-party certification) were filed on the Federal Register last week, Taylor shared some of the highs of the formation of the regulation as well as the challenges that are to come with implementation. “Many of us who were involved in the process 20 years ago didn’t imagine we’d get here today,” he said.
Right now FDA is looking at the big picture challenge of preparing the agency and industry, and actually getting the work done. Taylor called the implementation challenge “enormous”, thanks to the significant scale of the food system, and said the import piece of the regulation will take the most hands on deck. The ultimate goal of FSMA is real-time prevention versus reaction, and the regulation will require a lot of change within FDA. According to Taylor, the agency is revamping its internal management processes, along with its training and orientation programs, which also includes food safety culture training. Other activities include restructuring the inspection and compliance approach by realigning its field force to have fully specialized teams of inspectors.
One of the challenges that industry sees is the mindset shift in investigators from a resolutions approach to a systematic approach in assessing systems. When asked how FDA will get investigators to this level, Taylor admitted he was a lot more worried about the issue than he is now. The district folks in the front line are enthusiastic about the new approach and feel empowered by FDA’s new mission, he said. And while he didn’t want to be a Pollyanna about the extent of the effort, FDA knows that the agency workforce will not be 100% aligned on day one of implementation and is managing the process with this awareness.
Voluntary compliance is key, and while the weight of ultimate accountability stands on the shoulders of food and beverage companies, success cannot happen without collaboration with FDA. “We are convinced we’ll get 90% of the job done by working with those who are committed to doing the right thing,” said Taylor. “When that fails, there are other ways to deal with that issue.”
How will FDA enforce the new FSMA rules? It’s a question that has been circulating throughout industry over the past few months, and it will be answered at this year’s annual Food Safety Consortium conference next month. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA will deliver the opening plenary presentation on November 18, which will be followed by an “Ask the FDA” interactive town hall meeting. During the afternoon,
Roberta Wagner, deputy director of regulatory affairs at CFSAN will discuss FSMA implementation and FDA’s strategies for gaining and maintaining industry compliance with the new rules. The agency will also be participating in several conference sessions dedicated to the FSMA rules that will be finalized by November, including:
Foreign Supplier Verification
Preventive Controls in Human Foods
Preventive Controls in Animal Foods
Voluntary Qualified Importer Program
During the event, USDA’s Food Safety and Inspection Service (FSIS) will also be answering questions related to regulatory compliance and food safety issues at a Small Plant Help Desk.
Beyond FSMA-related topics, the Food Safety Consortium conference will feature several concurrent food safety and quality assurance tracks, workshops and training programs in compliance, food manufacturing and operations, supply chain management, food labs, and foodservice and retail. Food Safety Culture is an especially hot topic right now, and the conference will address the practical ways to actually measure behavior and start taking action. Frank Yiannas, vice president of food safety at Walmart will deliver a keynote presentation, “Food Safety = Behavior” on Wednesday, November 18.
With the upcoming regulations right around the corner, the good news is that FDA is still on track to meet the FSMA deadlines for August (preventive controls for human and animal food). But as industry looks to the future of FSMA and its implementation, resources and funding will be a challenge. Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, continued this message (which he declared several months ago) at the 2015 IAFP conference in Portland, OR.
“We’ve been given a brand new mandate by Congress to do things we haven’t done before,” said Taylor, as he emphasized that FDA will be in a do-more-with-less resource-challenged state. FDA would need, over the five years following the enactment of FSMA, $580 million, said Taylor. Over the first five years, FDA has received about $162 million (through 2015). “2016 is the absolute crunch year for FSMA funding,” he said. President Obama’s budget request for FY2016 would provide $109.5 million.
The issue is that there simply isn’t enough funding to get it all done, or as Taylor put it, not enough money to “maintain momentum towards comprehensive implementation of the FSMA vision.” As a result of the funding limitations, Taylor said that FDA will be making “hard choices” and will be forced to prioritize the funding that it receives. He indicated that the agency will focus on preventive controls implementation first. But this leaves a potential for disruption due to the investments needed for implementing the produce safety rule and building a strong system for imports, which may pose the biggest challenge over the next decade, Taylor warned. While trying to remain positive, the deputy commissioner also maintained that he wanted to be transparent about the situation.
FSMA will give FDA the ability and technology to act in real-time when issues occur, but it will also require new skills and training, as well as a shift in culture. In November, Taylor will be the opening plenary speaker for the Food Safety Consortium Conference and will surely have more insights, as industry will be entering the implementation phase.
FDA gives establishments another year to comply with the controversial rule.
Whether it was Congressional pressure or the heat felt from large retail businesses and industry associations, FDA decided to extend the date for compliance with the menu labeling rule by one year. The final rule, “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments”, was published on December 1, 2014 with the effective compliance date originally set for December 1, 2015. As announced in a Federal Register notice last week, covered establishments now have until December 2016 to make sure they comply with the requirements.
“The FDA agrees additional time is necessary for the agency to provide further clarifying guidance to help facilitate efficient compliance across all covered businesses and for covered establishments to come into compliance with the final rule,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, in an FDA notice.
“The final rule requirements are intended to ensure that consumers are provided accurate, clear, and consistent nutrition information for foods sold in covered establishments in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.” Source: Federal Register
“Covered establishments” are restaurants or similar retail food establishments that are part of a chain and have 20 more locations that conduct business under the same name and offer the same menu items. This can include individual franchises.
Since February, FDA has received four requests for an extension of the final rule’s compliance date. These concerns, which were submitted by a large retailer and industry associations, stated that there wasn’t enough time to fully implement requirements. The requests also detailed the extensive steps involved in compliance, which include:
Developing software and information systems that provide nutritional information
Rolling out standard operating procedures
Developing and installing updated and consistent menus (across retail chain operations)
FDA plans to issue a draft guidance next month that will answer questions it has received about complying with the rule. The agency will also offer educational and technical help to businesses covered under the rule and will work with state, local and regulatory partners to support nationwide compliance.
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