Tag Archives: food safety tech

Public-Private Partnership Aims to Fill Gaps in Supply Chain Interoperability

Partnership for Food Traceability seeking members to play key roles in decision-making.

As the food supply chain has become evermore global, the tracing of foodborne illness has become evermore complex. Although the Traceability Rule (FSMA 204) was enacted to mitigate that complexity, it has no provisions for interoperability between supply chains, primarily because FDA was not given the authority to require that.

So the Partnership for Food Traceability (PFT) has stepped up the plate to fill that gap. PFT is a public-private partnership between FDA, state officials, and all sectors of the food industry founded to help streamline the implementation of compliant traceability systems – accommodating both electronic and alternate/non-electronic methods to represent both large and small businesses.

A membership-based, sector-neutral organization, PFT provides a forum for stakeholders to come together with an equal voice to advance enhanced traceability. Companies that manufacture, process, pack, or hold foods and their trade associations can join as voting members; technology vendors and technical experts as non-voting members; and FDA and other officials will have formal, non-voting participation in full membership meetings, committees, and work groups. With the government officials serving as technical advisors to provide perspectives on regulations, guidance documents, policies, and practices, the membership will work to establish a comprehensive vision for enhanced food traceability in the U.S.

Understanding that it can be difficult for small stakeholders and businesses to have a voice in industry forums, “PFT has been designed to provide a level playing field so that everyone, regardless of your size, your sector, your business model, has an equal voice in the process of defining that vision,” said Leavitt Partners Principal Eric Marshall.

There’s also recognition that the implementation of traceability is difficult and dependent on a lot of people, companies, and sectors of the industry. “You can’t simply flip a switch and turn it on, Marshall said. “You need a clear, coordinated plan for how you get from here to compliance; and then not just to compliance, but how you get from basic compliance to actual optimization and interoperability. We think that the PFT can fill that role and provide that kind of a vision.”

“Today, traceability is the foundation for business growth,” said Kevin Edwards, Vice President of Global Market Development for the Global Dialogue on Seafood Traceability (GDST). “The key to global digital traceability is a common data language and an interoperable approach; advancing our mission cannot be done alone.”

Echoing a similar sentiment The Acheson Group Executive Vice President of Regulatory and Scientific Affairs Ben Miller said, “Our goal is to create that overarching vision and plan for traceability, but we are not intending to displace any of the work that’s come before, rather to extend it and bring it together in a town square concept. Importantly,” he added, “we don’t want to hinder innovation or efficiency.” In fact, Miller sees that as the principal return on investment of the group: “The more we can arrive at standardized approaches, the greater efficiency we will realize across the supply chain,” he said.

Additionally, the partnership is not starting from a blank slate. Rather, Miller said, “We have the benefit of standing on the shoulders of the success of the Partnership for DSCSA Governance developed by the drug industry. So we know this structure, based on previous experience, is one that can work well.”

The primary charges of PFT are to:
• Define open-source consensus business requirements and functional requirements for food traceability. The specific technical vision will be determined through decision-making mechanisms that promote balance, sector neutrality, and equitability, leveraging and incorporating existing work from various sectors.
• Coordinate pilots and share pilot learnings to advance electronic traceability. PFT will provide a forum to consolidate learnings from private and public pilots; identify and support new pilots; and promote industry/regulator interactions through pilot activity.
• Provide a forum for the sharing of common practices in supplier requirements for data sharing. Through a dedicated work group, PFT will strive to ensure its consensus business and functional requirements build on, and limit disruption to, supplier requirements, with each company free to establish its own standards. PFT will promote consistent and interoperable requirements by providing a forum for the discussion of promising practices.

With regulators also playing an essential role both in helping to define requirements for food traceability and as a recipient of food traceability information, FDA has formally agreed to collaborate with industry through the PFT to coordinate approaches across diverse supply chain sectors and help to more rapidly remove contaminated products from the market. Although interoperability is not a requirement of the Traceability Rule, it is becoming increasingly more important to how food traceability is operationalized within the broader food supply chain, and better food traceability means faster, more accurate, and more efficient outbreak investigations; and that requires FDA having a seat at the table with the broader food industry.

“PFT enables the ability to create an industry ‘town square’ that can bring the best thinking together from different functions and types of companies,” stated John Phillips, Pepsico Senior Vice President of Customer Supply Chain and Go-To-Market. “We have been involved in the planning group, and even in those sessions we have had great conversations on some of the challenges that we need to solve, and even came up with some creative ideas for many of them,” he said. Companies will benefit and help the industry by being engaged in this forum and ensuring their input helps craft the industry path forward.

It is important to understand that the PFT is for the entire supply chain through to retail foods and restaurants – large and small. “I think a lot of people assume that traceability is going to impact only the big restaurants. And that’s not true. We’ve done the math on this; we believe FSMA 204 will directly impact more than 85% of all restaurants across the United States – including mobile food trucks and food carts,” said National Restaurant Association Vice President of Food Science Patrick Guzzle. “We believe the impact will be great to the industry, so the importance of hearing from small vendors from small restaurants is really important as this all comes together.”

Whether a producer, manufacturer, processor, distributor, retailer or restaurant, becoming a member of PFT offers a strategic advantage that goes beyond compliance with the FSMA Traceability Rule. Members gain direct influence on how traceability systems are developed and implemented, a unique access to collaboration with the FDA, and the opportunity to network and collaborate with a diverse group of stakeholders across the food supply chain. Sharing best practices and learning from industry-wide approaches, can help a company innovate and improve its traceability processes, leading to greater operational efficiency, reducing duplication of efforts and lowering compliance costs, and ultimately providing long-term cost savings.

“In essence, PFT membership is an investment in your company’s future, ensuring that you play a key role in advancing safer, more transparent food supply chains that align with your company’s needs,” Marshall said.

Over the next few months, PFT will finalize the organizational details, begin an initial member sign-on period, and hold Board Member elections with a goal of holding its first Board Meeting on October 23. For more information and membership application, visit pftraceability.org.

 

Editors Note: the key leaders of the PFT are guests of Rick Biros’ webinar series, It’s 5 o’clock somewhere… A happy hour conversation about Food Safety & Quality, December 18 at 4pm EST. Register Here

 

 

Food Safety Consortium

2020 Food Safety Consortium Virtual Conference Series Agenda Announced

By Food Safety Tech Staff
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Food Safety Consortium

The agenda for the 2020 Food Safety Consortium Virtual Conference Series has been released. The announcement about the annual Food Safety Consortium being converted to a virtual series due to the COVID-19 pandemic was made last month. Due to a demand to provide attendees with even more content, the event has been extended a full month and is running into December. Food Safety Tech is the media sponsor.

The event will begin every Thursday at 12 pm ET, beginning on September 3 and continue through December 17. Each week will feature three educational presentations, two Tech Talks, and a panel discussion. Weekly episodes include food defense, food labs, pest management, sanitation, food fraud, listeria detection, mitigation & control, professional development, women in food safety, supply chain management, COVID-19’s impact and food safety culture.

Frank Yiannas, FDA deputy commissioner for food policy and response, will serve as the keynote speaker on Thursday, October 1 at 12 pm ET.

“Human connection is so important for events, and we know we’re not the only game in town. That’s why we’ve invested in a Conference Virtual Platform that can facilitate discussions, discovery, and connection that can continue whether our event is offline or online—and not end with the live streaming,” says Rick Biros, president of Innovative Publishing and director of the Food Safety Consortium. “Simply, the experience other food safety conferences are offering is not conducive to learning, staying engaged or take into consideration that you have a job to do during that week. This is why we have designed the Consortium’s program with short, manageable episodes that are highly educational.”

Registration for the 2020 Food Safety Consortium Virtual Conference Series is open. Keeping in mind that registrants may not be able to attend every week due to scheduling conflicts, there is an option to watch the each session on demand.

Tech Talk Sponsorship

Companies that are interested in sponsoring a 10-minute technical presentation during the series can also submit their abstract through the portal. For pricing information, contact IPC Sales Director RJ Palermo.

Innovative Publishing has also converted the Cannabis Quality Conference to a virtual event. More information is available at Cannabis Industry Journal.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo (The live event)

Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy.

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

food safety tech

Food Labs/Cannabis Labs Virtual Conference Includes FDA Comments on Proposed Lab Accreditation Rule

By Food Safety Tech Staff
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food safety tech

Next month join Food Safety Tech and Cannabis Industry Journal for the virtual conference, Food Labs / Cannabis Labs. The event is complimentary for attendees and will be held Tuesday, June 2 through Friday, June 5 (each day the event begins at 11 am ET). The event was originally planned as an in-person event but was converted to a virtual conference as a result of the COVID-19 pandemic.

The event kicks off with FDA’s comments on the proposed FSMA laboratory accreditation rule, which will be presented by FDA’s Timothy McGrath and Donald Burr. Other session highlights include FSMA’s impact on labs; navigating the regulatory pitfalls of cannabis lab testing; the evolution of the lab testing market; documentary standards and reference materials; and vulnerability assessment frameworks and food fraud mitigation strategies. Many of the educational sessions will be followed by Tech Talks, which will be provided by sponsors in the laboratory technology or service provider fields, who will educate attendees about solutions that can assist in the food lab and/or cannabis lab environment.

More than 500 people have already registered to attend! Don’t miss this unique opportunity and register now. Please note that only registrants who attend the live event will have access to the recording.

For companies interested in Tech Talk opportunities, Contact RJ Palermo (203-667-2212). Tuesday and Wednesday are sold out.

Frank Yiannas, FDA, food safety

2020 Food Safety Consortium Keynote Speaker Announced: Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response

By Food Safety Tech Staff
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Frank Yiannas, FDA, food safety

EDGARTOWN, MA, January 22, 2020 – Innovative Publishing Company Inc., publisher of Food Safety Tech, has announced that Frank Yiannas, deputy commissioner for food policy and response at FDA, will serve as the keynote speaker for the 2020 Food Safety Consortium Conference & Expo on October 21. The Consortium is the industry’s leading food safety event for networking and educational opportunities, and takes place October 21–23 in Schaumburg, IL (just outside Chicago).

“At last year’s Food Safety Consortium, Frank Yiannas spoke about the ‘sea change’ happening at FDA and the increased efforts on the part of the agency to drive more transparency and traceability. We look forward to his insights, as well as learning more about FDA’s progress on its initiatives, especially the New Era of Smarter Food Safety,” says Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference & Expo.

This year’s Food Safety Consortium Conference & Expo features three breakout tracks: Food Safety, chaired by Angela Anandappa, Ph.D., founding director of the Alliance for Advanced Sanitation; Food Integrity, chaired by Steven Sklare, president of The Food Safety Academy; and Food Defense, chaired by Jason Bashura, senior manager, global food defense at PepsiCo.

The call for abstracts is open until March 2, 2020.

Food Safety Consortium, Frank Yiannas, FDA
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

Food companies are concerned about protecting their customers, their brands and their own company’s financial bottom line. The term “Food Protection” requires a company-wide culture that incorporates food safety, food integrity and food defense into the company’s Food Protection strategy. The Food Safety Consortium Conference and Expo is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving food industry.

With the passage of the Farm Bill, there has been a great deal of interest from the food industry in cannabis-infused foods and beverages, which includes hemp and CBD. The Food Safety Consortium is co-located with The Cannabis Quality Conference & Expo, an educational and networking event for cannabis safety and quality solutions. Serving the Midwest market with a unique focus on science, technology and compliance, the Cannabis Quality Conference enables attendees to engage in conversations that are critical in finding solutions to improve regulatory compliance, quality, efficiency and cost effectiveness in a quickly evolving cannabis marketplace. Both conference programs run concurrently, thus, Food Safety Consortium registrants can attend any of the Cannabis Quality Conference presentations and vice versa. This year’s event takes place October 21–23 in Schaumburg, IL and is co-located with the Cannabis Quality Conference & Expo.

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ImEpik and Food Safety Tech Partner on Agreement for PCQI Online Training

By Food Safety Tech Staff
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EDGARTOWN, MA, Feb. 27, 2019 – Innovative Publishing Co., Inc., publisher of Food Safety Tech, has entered into a reseller agreement with ImEpik, an online training company that serves food manufacturers globally. Food Safety Tech will serve as a reseller of ImEpik’s PCQI online training course as per training that is required under FSMA.

“I’m pleased to announce our partnership with ImEpik, as it allows us to expand our efforts in giving the industry access to resources that are critical to food safety education and training,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo.

“Our ten-module online training program ensures that Preventive Control Qualified Individuals are proficient in the standards that are required under FSMA,” said Laura Lombard, CEO of ImEpik. “Providing compliance training in an online capacity also saves our ‘students’ time and money, as they can take the course any time and anywhere, without having to travel away from their job.”

As part of the partnership, the training will be offered at a reduced rate for professionals who also register to attend the Food Safety Consortium Conference & Expo, an annual industry event held October 1–3 in Schaumburg, IL. Full conference registration that includes PCQI training starts at $845 with the early bird discount. After September 13, the cost of the full conference registration with PCQI training is $995.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

About IMEPIK

IMEPIK is a market-driven, and research-based online training company, facilitates food safety training for food manufacturers around the world. With an emphasis on accessible and innovative training, ImEpik offers a unique advantage in providing effective training for you, your employees, your association members, or your clients to ensure food safety compliance and best practices. We offer Preventive Controls courses that include the “standardized curriculum” recognized by the FDA.

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Food Safety Tech, Food Safety Consortium Conference & Expo Announce Partnership with Alliance for Advanced Sanitation

By Food Safety Tech Staff
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EDGARTOWN, MA, Jan. 18, 2019 – Innovative Publishing Co., the publisher of Food Safety Tech and organizer of the Food Safety Consortium Conference & Expo, has announced a partnership with the Alliance for Advanced Sanitation. Angela Anandappa, Ph.D., director of the organization, will also be joining the Food Safety Tech and Food Safety Consortium Advisory Board. As part of this role, Anandappa will be a key resource on topics related to sanitation and will serve as chairperson for the Sanitation track at the Food Safety Consortium Conference & Expo, ensuring the presentations are relevant, accurate and balanced.

Angela Anandappa, Alliance for Advanced Sanitation
Angela Anandappa, director, Alliance for Advanced Sanitation

“The collaboration with Angela Anandappa and the Alliance for Advanced Sanitation is a significant enhancement to the Food Safety Consortium Conference & Expo,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Consortium Conference and Expo. “Angela brings a wealth of experience in food safety and molecular diagnostics, especially in her role developing programs that tackle hygienic design and sanitation issues.”

As a partner organization, members of the Alliance for Advanced Sanitation will also receive a discount to attend the Food Safety Consortium Conference & Expo in October.

“I look forward to working with Rick and his team at Food Safety Tech and the Consortium event to help industry further understand the issues we face in sanitation, the advances necessary for success and how we can share best practices,” said Anandappa, who is also a research assistant professor with the Department of Food Science and Technology at the University of Nebraska-Lincoln.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

About the Alliance for Advanced Sanitation

The Alliance for Advance Sanitation’s research, extension and teaching activities engage university of Nebraska–Lincoln faculty and address the needs and interests of the private sector partners. The overall goal of these activities is to develop improved sanitation practices that can be implemented by the food processing and affiliated industries. The Alliance’s mission is to create a safer food supply through advanced sanitation approaches and practices.

Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

Food Safety Consortium Sneak Peek – Food Defense Rule

By Sangita Viswanathan
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Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association

The Food Safety Modernization Act is the first instance of codified food defense regulations. This discussion is a hard look at the proposed food defense requirements and examining what compliance may look like. 

At the upcoming Food Safety Consortium, to be held November 17-18 in Schaumburg, IL, Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association (GMA), will address the key takeaways associated with the proposed regulation.

Following this presentation, Sarah Sunday from Kraft will talk about challenges the industry will face in implementing the rule as written and how the industry currently addresses food safety.

In a chat with Food Safety Tech, Cooksey provides a sneak-peek into her presentation.

FST: How are Food Defense requirements evolving under proposed FSMA rules?

Cooksey: GMA led industry in developing comments on the proposed Food Defense rule earlier this year, specifically focusing two things: one, food defense is different from preventive controls and two, food defense cannot be prescriptive—it needs to be tied to a facility-specific risk evaluation. While FDA has not yet re-proposed new food defense language as part of the supplementals released on September 29 of this year, we have good reason to believe that FDA has shifted some of its positions in light of our comments. We also believe another opportunity to submit comments on a food defense supplemental proposal, similar to what was done with Preventive Controls, would be a valuable use of time for both the industry and the Agency as they move towards issuance of a final food defense rule in May of 2016.

FST: What are some things that companies need to keep in mind to be prepared to comply with these requirements?

Cooksey: While this is the first time food defense is being proposed as a regulation, there are already some existing training materials available to industry to begin developing food defense plans. Since the requirement to have someone specially trained in food defense will likely be part of the final rule, GMA recommends that companies start early and take advantage of the available materials already available. GMA and the GMA Science and Education Foundation are planning to release additional materials and courses in 2015.

FST: Who should attend this discussion, and how would they benefit from it?

Cooksey: Security specialists at the facility and corporate level regulatory affairs staff who oversee food defense and/or FSMA within their companies should attend. Also, food quality assurance and food safety managers will need to know how the food defense plan will work in combination with food safety plans.

Click here for more information on the Food Safety Consortium, and learn from over 75 of the Food Industry’s top food safety SMEs.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

What To Expect When Expecting

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Childbirth and FDA inspections have a lot in common. Both are, in their most basic form, a natural part of life, both can be exceptionally strenuous while occurring and both, when finished, typically result in the highest form of extreme happiness and joy. But, more on that in a moment.

With the recent arrival of the Food Safety Modernization Act (FSMA), Congress has tasked FDA with the enormous responsibility of substantially improving the overall safety of our national food supply. To accomplish this goal, the new law imposes significant new legal (and, by extension) regulatory requirements on the food industry, and gives FDA a wide-range of incredible new powers and authority to enforce the new standards.  In turn, FDA will begin using those new powers in future food safety inspections to ensure that all food companies have implemented comprehensive, science-based written food safety plans, and have satisfied the long list of additional new mandates.

So, what can we expect when expecting?

Well, there is a great deal of apprehension in the industry. We all know that FDA is coming, but many companies are not quite sure what will happen when FDA finally arrives. Not a single company has yet to experience its first “FSMA inspection” and, as a result, the industry is, in part, begging for some help on how to better prepare for the arrival of this new, perhaps life-changing, event.  

We are here to help.

The first, and most important, step in getting ready for your first FSMA inspection is appropriately managing the broad range of emotions you will likely feel. Rather than being apprehensive, or resisting the inevitable, I recommend that my clients “embrace” the inescapable conclusion that FDA is coming to their facility. Like childbirth, the presence of FDA is now, or will soon become, and integral a part of their life. And, whether they like it or not, they have to prepare.

The second thing I tell my clients is that it’s okay to be at least a little apprehensive. It’s okay not to know what to expect. And, we’re here to help on that front too.

We understand, of course, that an FDA inspection can be a long and laborious process. For some, it will be downright excruciating. For others, it will instill a complete and total sense of helplessness.  

Although we all anticipate and hope that the process will end quickly and without complication, sometimes things can and will go wrong. There may be yelling, and we may even be asked, when things become really tense, to control our breathing. And, of course, sometimes, the process takes longer than we expected, and sometimes emergencies will happen. In these cases, stress builds, apprehension grows and panic, even if only briefly, may set in. Before it is over, you might even experience some chaos and, perhaps, a bit of confusion.

But, eventually, the tension subdues. And, like the incredible and indescribable joy and adulation that accompanies the arrival of a new life, so too is the overwhelming happiness that exists when the FDA compliance officers leave your facility — and are walking to their cars.

So, the first and most important lesson to master when you are truly “expecting” is to embrace the process, understand that it is a fact of life, know that it will eventually happen, and that it’s okay to be just a little bit scared. The second lesson you should embrace is to begin planning for the arrival of that inevitable day now. And, we stand ready to help there too.

In our next post, we will begin to explore why FDA is coming, and what FDA will “expect” when it arrives.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

When FDA Comes Knocking…

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

When you made the decision to work in the food industry, you also agreed to shoulder the incredible and important responsibility of feeding a nation. Put another way, you have given your own personal commitment, on a daily basis, to ensure that the food you are producing is as safe and wholesome as it can be.

In addition to this tremendous commitment and responsibility, you also agreed, whether you like it or not, to subject yourself to intense regulation and oversight by the U.S. Food and Drug Agency (“FDA”). Thus, if you have not yet had the opportunity to become intimately familiar with FDA, chances are that in the coming months and years, you will. Put simply, FDA is coming.

So, what does that mean?  That . . . “they’re coming…”

As you might recall, the phrase began its life as a line in a very scary 1982 movie called Poltergeist. And, in many respects, it encompasses what we are (or, will be) experiencing in the future as a regulated industry with the FDA in our mirror.

With food safety awareness increasing nationally among consumers and the media, and with the recent passage of the FDA’s Food Safety Modernization Act, FDA has been directed (and has consequently pledged) to begin inspecting food processors more often, more closely and more intimately. For this reason, whether you like it or not, you need to embrace the fact that in the coming months and years you will be closely … well, “haunted” by FDA.

Now that we have established that FDA is coming, what can (or should) we do about it? Well, just like in Poltergeist, locking the doors won’t help. Neither will closing the widows, dropping the shades, or completely ignoring the problem. And, no matter what, don’t go into the basement.

But, there are a number of things that can (and should) be done. Understanding that your next FDA inspection is unavoidable, and it will happen, it is absolutely critical to begin a dialogue today on what to expect, and how you should react, when it does.

Thus, in the following series of coming posts, we will walk you through the FDA inspection process, help you understand what to expect when it occurs, and give you advice on how to best respond.  We will examine closely the reasons why FDA may visit your facility, the purposes for which it is there, the things it will expect to see, and what you should be doing now to get ready.

Although some may consider this a “ghost” of challenge, we hope that we can provide greater transparency to FDA inspection process. With a little help, and some basic planning, there is no doubt in my mind you will survive.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

To Test Or Not To Test?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

In recent years, the federal government has become increasingly aggressive in its investigation of foodborne illness outbreaks, its inspections of food processing facilities, and its food safety enforcement activities. Notably, the federal government’s recent full-court, food safety press has been driven, in large part, by the increased visibility and awareness of food safety in the media and among consumers.

As FDA has been given additional food safety authority in recent years, the USDA has stepped up its game as well. Not wanting to be left behind, perhaps, USDA has begun focusing more aggressively on possible connections between slaughter establishments and outbreaks or positive regulatory ground beef samples. Under the Systems Tracking E. coli O157:H7 – Positive Suppliers (STEPS) framework, for instance, USDA will often take action against slaughter establishments that repeatedly appear in the STEPS system. This can take many forms, ranging from intensified environmental pathogen sampling to a Food Safety Assessment (FSA) for cause.

If USDA decides to conduct environmental pathogen sampling to “test” a company’s preventative controls or its compliance with the regulations, that company is always welcome to take its own “companion” or “sister” samples. With that said, I do not believe there is any benefit to actually doing it.

If an USDA environmental sample tests positive, the agency will not care whether a companion sample tests negative. Contamination is not always distributed evenly, and testing sensitivities will often vary. Thus, FSIS will in all instances treat its own result as a “positive finding.”

The same general rules apply with respect to environmental sampling, whether being conducted by USDA or FDA, for other pathogens like Salmonella or Listeria. In the event of a positive, the government will likely not care about a negative companion sample collected by the company, and will rely on its own results. Moreover, what happens if the agency sample tests negative, and the companion sample collected by the company tests positive? I have seen it happen many times.

Thus, here too, I do not see any compelling benefit, nor do I counsel my clients, to always collect companion samples. Moreover, if they elect not to do so, it also avoids the complexities of determining whether to hold, test or even destroy companion samples in the event a governmental sample ultimately tests negative.

With that said, if a company thinks that it may someday want to take companion samples when USDA or FDA performs its own environmental testing, I would strongly urge that the company adopt a written policy governing the specific circumstances under which such samples will be taken. This, of course, would apply to both FSIS environmental and finished product sampling.

Such a policy should clearly define the limited circumstances under which companion samples will be collected, and state that those samples will ONLY be tested in the event of a FDA or USDA positive. In this regard, the policy should articulate that the company will rely upon the governmental findings (and it really has no choice), while at the same time setting forth the justification for performing companion testing (i.e., in the event of a finished product regulatory positive to assist in the determination of the ultimate source). The policy should also make clear, however, that if the FDA or USDA sample tests negative, the companion sample will be discarded within a set period of time (i.e., 24 hours).

If a company adopts such a policy, and then closely follows that policy, it should be able to avoid any second-guessing from the agency (or a trial lawyer in a future lawsuit) if a subsequent issue arises or a recall later occurs. Moreover, assuming the policy provides the underlying justification for the protocol to be followed (which it should), I also think any moral obligation to test a companion sample in the event of an agency negative simply falls away.

Increasingly, companies will find themselves in circumstances where the federal government is demanding to take environmental or finished product samples. Think twice, in those circumstances, about whether a “companion” sample is really your friend.