Ideally, FDA wants to have the ability to use metrics for monitoring and measuring reductions in foodborne illnesses. However, this is extremely difficult right now, according to Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. At the 2015 Food Safety Consortium, Taylor responds to an audience question of whether metrics for FSMA compliance have been established.
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.
Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.
According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:
Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria 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.”
All images by amyBcreative photography.
Last night at the Food Safety Consortium, STOP Foodborne Illness held a fundraiser to honor those who have dedicated their careers to raising awareness of foodborne illness and promoting a food safety culture. Here are some moments from the event.
All images by amyBcreative photography
With the signing of FSMA in 2011, wholesaler and retailer executives are now legally responsible for the safety of their supply chains. In addition, FSMA’s focus on prevention and its seven new rules requires retailers and wholesalers to collect, manage and store multiple documents from each vendor for compliance. These documents must be accessible upon FDA request within 24 hours and extend two years back. And here’s the kicker: Senior executives are now responsible for the compliance of their supply chain with FSMA.
At the Food Safety Consortium, Affiliated Foods Midwest (AFM) will talk about their preparation for FSMA compliance and decision to move away from their “home-built” and “highly manual” compliance system, which stored both soft and hard copies of vendor documents. With FSMA rules focused heavily on documenting preventive measures, AFM executive leadership assessed the company’s gaps and determined they needed to be more proactive. John Grimes, director of safety for AFM, estimated that at the start of the company’s journey, about 30% of vendors were non-compliant with the three records they required: Certificates of Liability with specified limits, Hold Harmless forms and W-9s.
“We knew compliance built on trust was not enough and wanted more business documents and regulatory records collected. We also needed to increase compliance, be more proactive, and so we were looking to automate our systems,” explains Grimes.
AFM decided to adopt the cloud-based Compliance Management System to proactively manage both business-related documents and FSMA-related records. Once implemented, the wholesaler’s non-compliance among vendors was reduced by 60% in the first 90 days through proactive alerts, automated exception reporting and focused, personal follow up.
On Thursday, November 19, Randy Fields and John Grimes will discuss “FSMA Compliance Really Starts With Knowing Your Supply Chain” at the Food Safety Consortium. LEARN MORE“With our prior system I could find a requested document within 24 hours, but with the cloud-based compliance management system, I can pull it up and instantly share it with an FDA agent even before they have a chance to leave my office,” says Grimes.
Document management at AFM is now much more proactive vs. reactive. The Compliance Management System automatically sends alerts to Grimes and the vendor when documents are missing, when insurance limits are too low, or when a document is due to expire. The system enables AFM to proactively manage more documents by vendor than ever before.
The active approach that our staff enables its customers to take in managing compliance is really its differentiator. Each customer is provided with a dedicated team to reach out to their vendors to speed enrollment and quickly address their compliance issues.
According to Grimes, as more retailers and wholesalers adopt this type of system, the vendor community will move more quickly to embrace solutions that will help them comply with FSMA.
Industry awaits Federal Register publication.
Today FDA announced that it submitted the final FSMA rules for produce safety, foreign supplier verification and third-party accreditation rules. As we await final publication by the Federal Register, here’s a look back at some of Food Safety Tech’s recent coverage related to FSMA issues:
Is your supplier program aligned with new FSMA rules?
The Real Cost of Not Having an Effective Food Safety Management System
How Does SQF Certification Prepare You for Better FSMA Compliance?
FDA Awards $600,000 for FSMA Training Center
Not to miss event this month: FDA to Weigh In on FSMA Enforcement at Food Safety Consortium
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:
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.
Today FDA announced its strategy for training the food industry as part of the successful implementation of FSMA. This included awarding a $600,000 grant to the International Food Protection Training Institute (IFPTI) to establish a National Coordination Center. This center will serve an important function in the training process for the food industry.
“One size won’t fit all when it comes to training,” according to an FDA release. “The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements.” The agency indicated that there will be different options and delivery formats for the training, but wants all hands on deck—domestic and international stakeholders from government, industry and academia—to work with FDA on developing and delivering the training to food suppliers.
The major components of the FSMA Training Strategy include:
Cardiologist and former medical researcher Robert Califf, M.D. has been nominated as the next commissioner of FDA by President Obama. Coming from Duke University, Califf joined FDA earlier this year as the deputy commissioner for medical products and tobacco. He would replace Stephen Ostroff, M.D., FDA’s acting commissioner since Margaret Hamburg’s departure in March. The Senate must confirm the nomination, but opposition is not anticipated.
Califf clearly has a solid background in the medical field. His nomination comes at a time when FDA is undertaking significant issues right now, as it continues to manage the Affordable Care Act, the recently passed 21st Century Cures Act, concerns in tobacco regulation, and prepares for the implementation of FSMA.
