Tag Archives: Focus Article

Dana Johnson Downing, TraceGains
FST Soapbox

Six Signs Your Quality Department Is Still in the Dark Ages

By Dana Johnson Downing
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Dana Johnson Downing, TraceGains

Increasingly, we turn to technology to simplify tasks in our personal and business lives. Platforms like Facebook and Twitter allow us to connect, shop, advertise and publish with just a few clicks. LinkedIn is where people turn to prospect for new business, publish articles, discuss issues within industry groups, and look for a job. Need a ride? Apps like Uber and Lyft can usually get you where you’re going cheaper and more easily than a taxi. Devices like Google Home and Amazon Echo can listen to your voice commands to play music, manage your shopping list, adjust your lights, or tell a joke. And experiments are underway for driverless cars, which could make us the last car-owning generation.

Food safety documentation

With technology automating and solving so many tasks, how is it possible that food production is still dependent on paper-driven and manual processes?

The current way of doing things in the food and beverage industry is outdated, labor intensive, and—most importantly—error-prone. Under FSMA, companies need to be able to justify their decisions and processes, and of course, document them. It’s not only critical for brand protection—it’s a regulatory requirement. Ignorance is not bliss. Now, senior management is obligated to demonstrate their commitment to food safety and they risk criminal prosecution if their operations don’t measure up. There’s too much at risk to keep doing things the same old way. The following are some signs that your quality department is still in the Dark Ages.

1. You’re using clipboards.

In defense of clipboards, they were a wonderful invention. They are quite well suited for gathering signatures on petitions to save the whales or signing up for a PTA bake sale. But if you’re still using clipboards to log temperatures or document sanitation procedures, then your food safety records are not as current and organized as they could be. Inputting data later is not an effective use of time. Processes like these not only take away from the core competencies of your quality team, but they also make staff spend more time analyzing everything manually, which could lead to costly mistakes or inaccuracies. Tablets and PCs have replaced paper-based logs and other quality recordkeeping. Why make your staff do a task twice? By digitizing these records, you can ensure that your records are up-to-date in real time and reduce the likelihood of errors made during transcription. Trust me, your staff will thank you for rescuing them from extra data entry. Plus, the modern workforce expects digital solutions.

Filing cabinet, food safety documentation
Still using a filing cabinet to store documentation? All images courtesy of TraceGains

2. You’re still using a physical filing cabinet to store food safety documentation.

If you’re putting your food safety plan, supplier documents and certificates of authenticity (COAs) in a filing cabinet, you have a transparency problem. Your department isn’t the only one that needs access to those critical documents. And if everyone has their own paper copy, then you are going to have problems with version control. Solve your transparency and version control problems by keeping critical documents in the cloud where the data can be extracted, analyzed and shared internally and externally across your supply chain.

Food safety documentation
Three-ring binders are no longer an appropriate place to store important information.

3. Three-ring binders are for middle school, not food safety.

If your idea of ensuring compliance involves keeping COAs in a three-ring binder, you probably still have a flip phone, too. Seriously, 1980 called and they want their Trapper Keeper back. Whether your documents are in filing cabinets or binders, you still don’t have the transparency you need to efficiently share that information with your peers and other departments. Plus, your audits are sure to drag on longer than necessary if you are doing audits with stacks of three-ring binder instead of using an online platform where you can show the auditor any documentation they need with just a few clicks of a mouse.

4. Your suppliers send critical food safety documents to you via e-mail.

Email is a great way to communicate. It’s just not the best way to gather and manage supplier documents. Admit it; we all get behind on email, and sometimes things slip through the cracks. What happens if an out-of-spec allergen declaration gets buried under the 586 emails you receive each day? I can tell you, it’s certainly not good. The alternative is allowing your suppliers to upload those documents into a platform, so they are immediately available to you and anyone else in the company that you’ve given access to the system. Leveraging a platform, you also have access to a dashboard that can quickly show you which suppliers are in compliance and which ones have issues that need to be addressed. And if you have incoming certificates of authenticity (COAs), you can sit back and rely on software to read those documents for you and spot anything that doesn’t match your specifications or purchase order details. Isn’t it time that you not only collected supplier documents, but really use that data within the documents to better manage your incoming material to ensure food safety and quality?

5. You rely on file sharing to store your food safety and quality documentation.

SharePoint and other file sharing systems may look more modern than the paper alternative, but they weren’t designed specifically for vendor management or supply chain transparency. They can file and retrieve, but it’s not automated document management. Ask yourself how long do you or fellow employees spend searching for requested documents? Perhaps you need certain documentation for your GFSI/FDA audit, but different pieces of information are stored in various locations, either in a shared drive like SharePoint or a custom vendor portal. Every minute counts when it comes to document retrieval. These systems are often a little more than an electronic filing cabinet. They can store the information electronically, but unless it’s gathering, analyzing, validating and sharing that data across all departments, you still don’t have an automated system.

Spreadsheets, food safety documentation
If you’re still using spreadsheets, consider moving data to the cloud.

6. Spreadsheets are the main source of tracking your data.

While quality managers at competing companies are investing in the latest technology, other food companies are still inputting supplier lists and data in spreadsheets. Often, managers are reluctant to move their data to the cloud, opting instead to stick with what they know by using a spreadsheet that lacks a comprehensive system to track supplier performance in real time. This is a major disadvantage when different departments need one source of the truth about supplier performance and trend data about incoming material. Not only are spreadsheets hard to share and keep up-to-date, but the majority of them also contain errors.

  • A report by Ray Panko, a professor of IT management at the University of Hawaii, found that 88% of spreadsheets contained errors.
  • Coopers & Lybrand found that 91% of spreadsheets with 150 rows or more produced results that were off by more than 5%.
  • In a sample of 22 spreadsheets, KPMG found that 91% contained serious errors.

If your executives think automated supplier, compliance and quality systems are a “nice-to-have,” chances are you are still operating in the Dark Ages. This final advice is true no matter what software your business is thinking of implementing. Whatever the aims of the system, you must choose a long-term partner. Make sure your vendor can solve these six problems and meet the needs of your business now and in the future.

FDA

FDA Issues Draft Guidance on Inspection Refusal for Foreign Food Facilities

By Food Safety Tech Staff
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FDA

Today FDA released a draft guidance to provide information about what actions by a foreign food establishment or government are considered a refusal of inspection. “FSMA gives the U.S. Food and Drug Administration the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment that produced the food,” FDA stated in a release.

The 12-page draft guidance, Refusal of Inspection by a Foreign Food Establishment or Foreign Government, outlines how the agency goes about scheduling inspections of foreign establishments (despite the fact that FDA is not required to pre-announce inspections), the inspection activities themselves, and very detailed examples of what it considers an inspection refusal from a facility (from a lack of communication with FDA that delays the agency’s request to schedule an inspection, to preventing an FDA investigator from entering a facility, when a facility sends staff home and tells FDA that it is not producing product).

The draft also details what it considers to be refusal of inspection by a foreign government. Some of the actions include preventing FDA investigators from entering the country or asks them to leave the country before an inspection is scheduled; and limiting access to areas of the facility that manufacturing, processing and packaging occurs; and limiting investigators from collecting samples for analysis.

If either a foreign food establishment or a foreign government refuses an inspection, they will stay on the agency’s Red List of Import Alert 99-32 until FDA is able to schedule and conduct an inspection.

Stephen Ostroff, FDA

FDA’s Ostroff Says Foodborne Illness Still Resistant to Change

By Maria Fontanazza
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Stephen Ostroff, FDA

“Everything changes; nothing remains without change.” It’s the Buddha quote that Stephen Ostroff, M.D., FDA deputy commissioner for food and veterinary medicine, used to kick off his plenary presentation at this year’s Food Safety Consortium. Yet “there is one thing that is stubbornly resistant to change,” he commented, and that’s foodborne illness. The incidence of culture-confirmed human infections hasn’t improved, and it can be seen in the number of cases reported through CDC’s FoodNet system. Why?

Stephen Ostroff, FDA
FDA’s Stephen Ostroff, M.D. answers audience questions during a town hall meeting at the 2017 Food Safety Consortium.

Ostroff has a few theories. First, there are much better diagnostics and surveillance systems in place versus 10 or 20 years ago. “Those improvements in finding the cases may be masking improvements that have occurred,” he said. Second, looking at the data from the big picture perspective may mask positive sub-trends. “We are actually doing better,” Ostroff said. “Within the data, there is some good news and some bad news.”

Ostroff also proposed that emerging food safety risks are having an impact on the rates of foodborne illness, including new trends that are altering the food landscape. The global food supply is more diverse than ever. In addition, the change in consumer preferences and eating patterns may lead to gravitation towards higher risk foods that are improperly handled. Other areas of risk include new methods of food delivery (i.e., e-commerce—Ostroff added that within a few years, up to 20% of our food will be delivered to our homes.). The final risk he touched on was new food types, such as synthetic foods (i.e., synthetic meat). “Nobody is quite familiar with the potential hazards associated with those foods,” he said.

FSMA Update

Over the past year, a new administration has come into place, along with a new FDA commissioner. In addition, compliance dates for six out of the seven foundational rules are now in effect (the compliance date for the Intentional Adulteration rule is July 2019). Although the new administration is focused on reducing the regulatory burden, it doesn’t appear to be impacting FSMA requirements. “To date we have no requests to change or delay FSMA requirements,” said Ostroff. “And that’s very good news.”

Third-party certification program. In June FDA launched a website through which organizations could apply to be recognized as an accredited body. Ostroff said the response and interest related to the program has been “overwhelming”, with hundred of entities visiting the agency’s website to learn more.

Voluntary Qualified Importer Program (VQIP). The agency anticipates that the application window will open January 2018 (however, Ostroff hinted that it may be delayed a bit). October 2018 is the projected start of the first benefit period.

FSMA Fixes. “There have been quirky issues that ended up in the FSMA regulations either because of the way FSMA was written by Congress or because of the way the regulations ended up,” said Ostroff, who added that the most problematic “quirk” is the intersection of whether an entity must comply with the Preventive Controls rule or the Produce Safety rule, and it all comes down to the farm definition. As a result, the agency extended compliance dates for a number of situations, one of which involves the agricultural water provision (January 2022 for large farms, January 2023 for small farms, and January 2024 for very small farms). Related to this provision, FDA is looking to reducing the regulatory burden but will keep standards in the lab analytic methods, frequency of testing and determination of water quality.

Training. The FDA has been partnering with many entities around the world to implement FSMA training both for industry and regulators. More than 50,000 people have been trained for the Preventive Controls for Human Food rule and more than 5000 have been trained for the animal food rule.

Inspection. At last year’s Food Safety Consortium, there was a lot of chatter about agency enforcement and inspection. Although Ostroff didn’t touch on enforcement, he provided a few figures on inspection activity for fiscal year 2017:

  • Preventive Controls for Human Food
    • Modernized CGMPs: 720
  • Preventive controls: 165 (46 outside of the United States)
  • Preventive Controls for Animal Food
    • CGMPs: 220
  • Foreign Supplier Verification Program: 285
  • Produce safety rule: 8 (sprouts)
Food Safety: Past Present & Future panel

Discussing Key Issues: Images from the 2017 Food Safety Consortium

By Food Safety Tech Staff
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Food Safety: Past Present & Future panel

Image credit: Michael Conaty

Cara Pahoyo

5 Burning Questions About The Rise In Foodborne Illness

By Cara Pahoyo
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Cara Pahoyo

The food industry has been one of the most celebrated and fastest-growing industries over the last decade or so. Which is no surprise, considering how much food is now being consumed, or posted on Instagram, on a daily basis. Pop-up food carts and hole-in-the-wall food places have been a huge hit too and even inspired a number of Hollywood films about the tough competition and revolutionary marketing tactics that have taken over the food industry (see: Jon Favreau’s Chef and Bradley Cooper’s Burnt). It’s good times, for sure. Well, for the most part, I mean.

When did foodborne illness become a major concern in the US?

Unfortunately, it’s not just the revenue that’s on the rise, because food borne illnesses too are making the headlines as of late. Talk about spoiling (no pun intended) the fun, eh? Well, according to the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, the number of foodborne disease outbreaks resulting from imported foods increased during surveillance years 2005 to 2010.

Where are the numbers coming from?

Dr. L. Hannah Gould, Ph.D., a senior epidemiologist at the CDC, revealed those findings during an oral presentation here at the International Conference on Emerging Infectious Diseases in 2012. According to the CDC, 39 foodborne disease outbreaks were reported in which the implicated food had been imported into the United States. These outbreaks resulted in 2348 illnesses, 434 hospitalizations and 3 deaths.

How many are affected?

Though foodborne illnesses are often never formally reported, about 48 million Americans, or one in six, get sick each year from food, the CDC estimates, with 128,000 hospitalizations and 3,000 deaths. In fact, in 2014, 19,542 cases of infection were traced from 15% of the US population being surveyed by CDC.

Why is it on the rise?

The culprits? Chances are, you’ve been storing them somewhere inside your establishment: packaged caramel-coated apples, frozen ice cream sandwiches, fresh peaches and nectarines, frozen meet, etc. Not exactly the answers you were expecting, perhaps?

According to experts, the growing popularity of packaged foods such as pre-cut fruit and prepared sandwiches has heightened the risk of spreading foodborne illnesses. Furthermore, they have identified that contamination can occur between preparation and packaging, or in high-tech processing plants, after heating to destroy harmful bacteria and before packaging. Which means, somewhere in the last decade, we lost our way (or something like that).

What can we do to stop foodborne disease from spreading?

The whole fiasco regarding foodborne illness is a public safety concern and must be addressed by everyone. However, while adjusting individually may not be a problem for most of us, the same cannot be said for food places and restaurants. Just imagine the public relations horror for restaurant managers if any of their customers get sick while dining at their place?

Restaurants must be more strict and thorough when addressing food safety concerns. The entire crew must be trained when it comes to food handling and a food safety manager must also take charge in overseeing procedures in the kitchen. In fact, proper storage and disposal must also be adequately done at all times. With those safety measures in play, establishments will be able to showcase their commitment to adhere with local food standards and basic food handling procedures. That’s a step in the right direction, for sure.

Summing up, foodborne illness is definitely a manageable concern and will likely not become a factor that will hinder the overall growth of the food industry. However, the fact that it can be controlled and yet still recurring means that there’s still a fair amount of work needed to be done to improve the industry in other aspects—and that isn’t necessarily a bad thing (at least not yet).

Scott Mahloch, FBI, Food Safety Consortium

U.S. Food System Continues to Be Soft Target for Terrorism

By Maria Fontanazza
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Scott Mahloch, FBI, Food Safety Consortium

Sadly, more and more these days, terrorism has become a prevalent concern. The food sector is not immune to threats either, especially as soft targets and lone wolf attacks become more common.

Food Safety Tech discussed the issue with special agent Scott Mahloch, weapons of mass destruction coordinator for FBI Chicago, during a conversation leading up to this year’s Food Safety Consortium, where Mahloch will be speaking.

Food Safety Tech: In the past year, have there been any changes or new developments in the way in which the FBI conducts outreach to the food industry?

Scott Mahloch presented FBI’s Role in Food Defense on November 29 at the 2017 Food Safety Consortium | Learn moreScott Mahloch: The U.S. food system continues to be a soft target, largely unprotected from the insider threat. Since last year’s Food Safety Consortium we have done targeted outreach to the top dozen food processing facilities in the Chicago area. We worked with our intelligence team, came up with a list of questions and spoke with food safety managers and facility managers regarding the insider threat and educated them on the WMD [FBI’s Weapons of Mass Destruction] program.

FST: Do other divisions of the FBI work in a similar manner as the Chicago division?

Mahloch: It really depends on the office. We have 56 field offices around the nation. In every office we have a WMD coordinator, so it depends on his or her area of responsibility and what that area commands. For example, our office in Springfield [Illinois] is more agriculturally based than we are here in Chicago. Their food outreach would be very similar, but they might be looking at the farms and the agricultural aspect of food production.

FST: Are there any imminent threats to the food sector? Have you seen anything new over the past year?

Mahloch: No, we have not [seen] anything here in the homeland. The bad guys overseas have always expressed interest in attacking food and water, and that remains the same. It’s more the international terrorist groups that have always stressed this in the past. That’s one of the drivers of why we’re so involved in this outreach—we never want that to happen here in the United States. To get in front of the threat, we go out and talk to subject matter experts in this area, the facility managers and food safety managers to get the information out there.

FST: As FBI takes a proactive approach to food defense, what responses have you seen with food companies thus far?

Mahloch: It’s been very positive. People out there believe in our mission and in what we’re doing, and they want to ensure safety and security in their facilities. Communication has been great; they’ve welcomed us into their facility, taken us on facility tours, shown us production lines and answered our questions. It’s been a great relationship.

FST: Does the FBI concern itself with global food supply chain security in terms of how it affects the United States?

Mahloch: Yes, absolutely. What I do is more on a local level here in Chicago, and the same goes for my fellow coordinators in the field offices. We focus on our area of responsibility. The WMD director has a unit that deals with food and water safety. We also have an overseas lead attaché program that works—those folks are also involved in WMD.

FST: What can attendees look forward to hearing about during your presentation at this year’s Food Safety Consortium?

Mahloch: A lot of it will be education and just getting the word out there that the FBI has a role in food safety, food protection and water safety. A lot of people don’t realize the FBI is involved in this. Usually when you think food protection, you think the USDA, FDA, Homeland Security and other agencies that have programs. So a lot of it will be education and telling [attendees] what we do, what we’re about, and where they can turn in a time of need for additional resources. That’s probably the biggest takeaway from the FBI.

[In addition], on outreach and how the FBI is perceived, what we’ve noticed is that we’ve gone into facilities and their defenses are up a bit because they think the FBI is going to regulate, take a look at their processes and inspect. That’s really not what we’re about. We’re not a regulator—we don’t go in and try to change internal processes or rip apart what they’re doing. What we do is strictly education. There are other regulatory bodies that mandate how things are supposed to be shipped, stored and processed. That’s not the FBI. Sometimes there’s that misconception when we go in and want to do some outreach—that FBI is there to regulate. That’s not the truth. We’re a resource and we’re trying to open those doors of communication.

And as far as the threat in the homeland, right now there is none and we continue to try to stay ahead of the threat through education and being a resource.

 

Brendan McCahill

Four Ways Technology Can Ease The Burden Of New FSVP Compliance Regulations

By Brendan McCahill
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Brendan McCahill

What if it was possible for importers, or the customs broker that imports food into the U.S. on behalf of shippers, to stop salmonella-tainted food before it arrives in the hands of a consumer? While there are assorted systems in place to prevent contamination, often times, grocery stores and other businesses are unable to track the supply chain of foreign food importers, leaving customers blind to the origin of a product.

Descartes FSVP InfographicThe U.S. Food & Drug Administration (FDA) is working to address this issue with the Foreign Supplier Verification Program (FSVP). The new program makes importers responsible for better tracking hazards, identifying their suppliers and ensuring that their food is compliant with processes that meet the FDA’s standards for preventive controls and safety.

On the surface, this visibility seems like a great benefit to both consumers and businesses. But what will it mean for importers as they try and keep up with reporting requests and new regulations?

To prepare businesses for the continuing list of FSVP regulations that must be implemented by 2019, here are four ways in which technology will ease the burden and make the food industry’s supply chain even stronger.

1. Gain a holistic view of the supply chain

For navigating FSVP specifically, technology provides food importers with an efficient way to identify and better trace a supplier network, as well as and a quick and easy way to locate D&B D-U-N-S® Numbers*. For importer self-filers and customs brokers, similar solutions enable them to streamline techniques to transmit data to U.S. Customs & Border Protection (CBP) in the Automated Commercial Environment (ACE) as their goods move across borders, as well as to store details, such as D&B D-U-N-S Numbers, Harmonized System (HS) codes and more.

Ultimately, food importers and customs brokers that enlist the expertise of one technology provider can better prepare for FSVP compliance. While piecing together a technology solution using multiple logistics technology providers may work in the short term, a forward-looking, compliance-centric approach that aligns with future regulations must be adopted – one that gives a holistic view of the supply chain via one service provider.

2. Identify and better trace the supplier network

Supplier verification is an additional area of FSVP whereby suppliers must undergo periodic review and approval, and must be identified in order to perform an effective supplier hazard analysis and evaluation. Accurately identifying suppliers is a highly complex task due to intricate supply chains, compound food formulations and the number of SKUs in a product line. Plus, a supplier ecosystem evolves over time for many reasons, such as changing cost and consumer demand. Simply put, managing a complex supplier network can be a drain on resources and costly. Luckily, technology can help.

Logistics solutions that feature periodic updates that adapt to changing supply chains can help food importers better target suppliers to ensure regulations are followed. It can also help focus on suppliers with higher shipment volumes to optimize data management and prioritize compliance responsibilities.

In the event a food code is subject to FSVP, customs brokers are required to input the importers’ name, mailing address, email address and D-U-N-S Number. Because the FDA’s consumer protection function is dependent on the entry process, brokers are aware of the added scrutiny shipments subjected to FSVP-related information will be under, especially if any of the above information is noted as Unknown (UKN). Logistics technology can help automate this process and ease custom entries, booking, security filings and more.

3. Streamline techniques to transmit important data

Transmitting data to the CBP as goods move across borders can be challenging in its own right. Basic customs issues include import/entry process, tariff classification, valuation and duty assessment.

Innovative technology solutions can help businesses go beyond the bare minimum to improve the speed and accuracy of submitting entry and Partner Government Agency (PGA) data to CBP. Users can receive and react to responses and customs status messages by exception. Proactive alert functionality can notify users of actionable items including rejections, intensive exams, requests for electronic invoices, Temporary Importation Bonds (TIB) expiration notices and more. On-demand solutions also enable brokers and forwarders the ability to run complex international operations more efficiently.

4. Dedicate D&B D-U-N-S numbers for imported food product

The D&B D-U-N-S Number was selected by the FDA as the recording system to identify importers by a common reference system. The FSVP regulation indicates that a D-U-N-S Number must be provided by an importer for each line entry of food product imported into the U.S.

Today’s complex food industry means importers often work with an extensive ecosystem of subsidiaries, affiliates and Doing Business As (DBA) divisions. To comply with FSVP, technology can help quickly locate the D&B unique identifier for each member of the network, and streamline the complicated process of managing each line entry of food product offered for importation into the U.S.

A tech-driven pathway forward

There is no doubt that the new FSVP regulation is complex. U.S. food importers are now responsible for ensuring compliance in an effort to improve the safety of food entering the U.S. This will require food importers to fully understand the regulation on a practical level and react accordingly, using technology to its fullest.

Leading businesses should consider the FSVP regulation as an opportunity to look forward and prepare. With the right logistics technology and processes in place, organizations can improve their readiness to enable compliance, improve data management and execute a holistic regulatory strategy to meet the new stringent requirements.

* D&B D-U-N-S Numbers are proprietary to D&B, are licensed from D&B and are for internal use only. 
D-U-N-S is a registered trademark of D&B.

Patricia Wester, PA Wester Consulting

Q&A On FSMA Audits: A Conversation With AFSAP CEO Patricia Wester

By Food Safety Tech Staff
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Patricia Wester, PA Wester Consulting

As a trade association for auditors and the auditing industry, AFSAP has researched the various references to audits found in all of the FSMA rules, and monitored the steps taken across the auditing community to meet these requirements. In this Q&A, we sit down with Patricia Wester, chief executive officer of AFSAP, to talk FSMA audits, criteria for supplier audits, preventive controls and FDA guidance. She will be running the Pre-Conference AFSAP Food Safety Auditing Fundamentals Course at this year’s Food Safety Consortium.

Background on the AFSAP and FSC Alliance

In July 2016, GFSI announced they would re-open the Guidance document revision process so that FSMA’s requirements could be considered for inclusion. When the final GFSI Guidance document was released, it included most of FSMA’s requirements. At this point, the Schemes still had to accommodate these changes, which were then provided to the CB’s. Depending on the Scheme, a CB also had to consider including content to address any FSMA related gaps. In the end, these audits could take more than a year to reach the market, and depending on the individual site’s renewal period, it could be many more months before a supplier was actually audited.

Patricia Wester moderated the Plenary Panel “What’s Next for Audits”
and running the
Pre-Conference AFSAP Food Safety Auditing Fundamentals Course at the
2017 Food Safety Consortium November 29 – December 1, 2017 in Schaumburg, IL.

Recognizing the need to inform the market, the inaugural Plenary Panel on Auditing, moderated by AFSAP’s Patricia Wester was presented at the 2016 Food Safety Consortium meeting. Dr. Ostroff opened the discussion to share FDA’s perspective on the use of audits for FSMA. His remarks were followed by representatives from GFSI, Schemes and CB’s as each described their role and recent activities to meet the new regulatory requirements, and provide insight into the timelines involved.

Dr. Ostroff has agreed to join us again for the 2017 meeting, and will participate in the Plenary Panel “What’s Next for Audits” as Industry, Retailers and the auditing community prepares for the accredited certification audits necessary for VQIP.

FoodSafetyTech: How are audits used in FSMA?

Patricia Wester: In the Third Party Audit rule, FDA outlines an accredited certification program for imported food that applies in 2 specific situations. The first applies to any imports FDA designates as “a high risk food” and the second is the use of certification audits for importers in The Voluntary Qualified Importer Program, (VQIP). Under VQIP, participating importers are required to source their products from suppliers that are certified under the FDA program.

In addition to the certification audits for VQIP and high-risk foods, audits are one of the options for supplier verification activities under the human and animal food preventive controls rules. When the hazard analysis identifies a raw material has a serious hazard, (SAHCODHA hazard), that ONLY the supplier controls, a supply chain preventive control is required, and the supplier verification activity must be an onsite audit. FDA allows some flexibility here, the audit can be a second or third party audit as long as it meets the requirements listed in 117.435, and is performed by a qualified auditor as defined in 117.3. These requirements are applicable to audits used to verify foreign suppliers (FSVP) as well as domestic suppliers.

FST: Don’t GFSI Scheme audits meet the criteria for Supplier Audits?

Wester: FDA allows the use of any audit that meets FDA’s criteria for audit content. This includes second party audits executed by employees of the receiving facility and third party audits, including GFSI audits, as long as they meet the requirements for audit criteria and are performed by a qualified auditor.

FDA acknowledges that the GFSI Auditor Competence provisions are consistent with the Agency’s findings, but that recognition does not extend to the audit criteria/content of GFSI audits.

In fact, any audit program in use prior to the publication of FSMA’s rules would probably need to be updated for these new requirements. GFSI, the Schemes, the CB’s, and others involved in the delivery of audits have likely all updated their audits to eliminate the major gaps, however, there are still some key FDA requirements that remain unmet.

FST: So, even though audit programs have been updated for FSMA’s new requirements, they are still missing some of FDA’s requirements? Why didn’t they just add everything?

Wester: In most cases, it appears to be due to a misinterpretation of the audit criteria that underpins all FDA’s audits. FDA’s audits focus on assessing a suppliers compliance with “applicable food safety regulations, the HACCP and/or Food Safety Plan and the plan’s implementation”. The Preventive Controls for Human Food Rule states the audit requirements in Subpart G:

§117.435 states:

If the raw material or other ingredient at the supplier is subject to one or more FDA food safety regulations, an onsite audit must consider such regulations and include a review of the supplier’s written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled.

We (FDA) have revised phrasing to state “and its implementation” to emphasize that implementation of the plan is distinct from the plan itself (e.g., § 117.126(c). (The PCHF Final rule preamble)

Similar phrasing such as “any applicable FDA regulations” is used elsewhere when FDA discusses audit criteria, such as FSVP and VQIP and the Third Party Certification Audit rules. Further, the PCHF rule, §117.190 provides a comprehensive list of “Implementation Records” that can be used as a guide to understanding what meets this element of the FDA’s requirement.

The auditing community and Industry have assumed the regulatory reference was limited to the FSMA regulations, such as Preventive Controls for Human or Animal Food or the Produce Safety final rules), and has focused on those regulations to update their audit programs. Other FSMA regulations, such as Intentional Adulteration and Sanitary Transport, could easily be considered part of the requirement, so there are a few audit options that include those rules.

FST: What about products that are exempt from the Preventive Controls Rules?

Wester: Audits for products that are exempt from the PCHF (human Food) rule, such as Juice and Seafood HACCP, are probably available under a general HACCP format, but they may not include the level of detail required under FSMA, and would have to specifically requested when arranging a supplier audit.

Audits for other PCHF exempt products, such as bottled water or low acid canned foods, would be audited using a general food safety audit, with the specific product treated as a product category under that audit. Once again, these audits lack the product specific regulatory content and implementation details required by FSMA.

The question becomes, which FDA regulations (beyond FSMA) apply to an audit used for regulatory compliance and how much detail in the audit is necessary?

In other words, what is the full scope of regulations needed for the audit, and what are the audit criteria? Is it just FSMA or does it go further?

FST: Where does one look for this information? Does FDA offer any guidance about the scope of the audit?

Wester: The CFR, or Code of Federal Regulations is the starting place for regulations. Finding the regulatory information would not be difficult, Title 21, CH 1 Parts 1-1499 include FDA’s food regulations. In addition each part can have multiple subparts etc.

Given the sheer quantity of regulations, and that some are product specific while some are not, developing different audits for all of the possible regulatory combinations would be a daunting task and enormously costly. Remember, every auditing company will have to go through this process.

There are FDA references to scope and criteria in several responses to comments:

Audit Criteria means the set of policies, procedures or requirements used as a reference against which audit evidence is compared. During regulatory and consultative audits, accredited third-party certification bodies will examine compliance with applicable food safety requirements of the FD&C Act and FDA regulations within the scope of the audit. In consultative audits, the third-party certification bodies also may be conducting an examination to determine conformance with applicable industry standards and practices.

The applicable requirements that accredited third-party certification bodies and their audit agents will use relate to the food safety standards under the FD&C Act, such as the adulterated food provisions in section 402 of the FD&C Act and the provisions on the misbranding of food allergens in section 403(w) of the FD&C Act. The applicable requirements of the FD&C Act and FDA regulations would depend on the type of eligible entity being audited. Other examples include labeling requirements and the CFR citations listed under scopes.

Certainly, more detail than this is needed, and AFSAP is working to engage all parties, including FDA, in collaborative discussions to resolve these questions and concerns. The auditing community will need to address these issues in the near future, and industry should be vigilant to understand the requirements and make sure any audits used for FSMA are compliant.

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Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
Bill Bremer, Principal, Food Safety Compliance at Kestrel Management LLC

Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”

Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.

Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?

Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).

Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.

We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.

This is a high-profile area for FDA to inspect.

Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.

Food Safety Tech: What methods should companies employ to meet FSMA requirements?

Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.

However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.

Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?

We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.

A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories
Food Genomics

Part II: Logistics of GenomeTrakr

By Douglas Marshall, Ph.D., Gregory Siragusa, Ph.D.
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Last month in Food Genomics we asked FDA scientists Drs. Marc Allard and Eric Brown to help the readers of Food Safety Tech understand the process used by GenomeTrakr. In part two we cover some logistical and more general questions.

Greg Siragusa/Douglas Marshall: Why should a food producer or processor submit its own pathogen isolates to GenomeTrakr? Are there any legal liabilities incurred by doing so?

Eric Brown/Marc Allard: The database is available publicly for any outside laboratory to be able to rapidly compare their new WGS data to all of the data in the database. The data is all publicly available so food industry members should carefully consider the strengths and weaknesses of sharing data. The main reason for sharing data is that if any matches arise then this would be immediately known for an investigation and corrective action. With knowledge, companies can better understand their risk and exposure to occasional contamination events.

Siragusa/Marshall: Are there private third-party providers who will perform the same method of sequence analysis for private companies that GenomeTrakr uses in the FDA?

Brown/Allard: Yes, as all of the FDA methods of data collection and analysis are fully transparent and publicly available, any expert third-party provider could easily set up and reproduce the GenomeTrakr methods. Third-party support may be an excellent mechanism for food industry partners that wish to examine the pathogens they have found connected to their products but do not wish to maintain an active WGS laboratory. An internet and reference search will uncover these private third-party providers, as this is a growing market with a diversity of services provided. The FDA works closely with the Institute for Food Safety and Health (IFSH) to share information that may be valuable to their industry partners.

Siragusa/Marshall: Will the FDA perform analysis of isolates for private parties and the sequence not made publicly available?

Brown/Allard: No. While we will sequence relevant strains from many different sources, as a matter of protocol we will submit all of these data to the GenomeTrakr database. That is, currently, the FDA sequences and uploads all available genomic strain data. All data are made publicly available through the GenomeTrakr and NCBI pathogen detection website. The metadata describing each isolate only includes species, date, state location and a general food description which could include the type of food (e.g., an egg) and/or the type of sample (e.g., environmental swab, surface water, sediment, etc.) as well as production date, pH, fat content and water activity. No trade or industry brand names are made publicly available, and the location is ambiguous down to the state level to allow for anonymity of specific farm names or processing centers. An example of metadata in the GenomeTrakr database might include Salmonella, from Washington State in spinach from 2015.

Siragusa/Marshall: Is the CDC tied into GenomeTrakr and if so, how?

Brown/Allard: CDC labels their clinical WGS data as PulseNet with the data uploaded to the NCBI Pathogen Detection website. USDA FSIS also uploads the isolates that they have collected and sequenced from foods that they regulate. All of this WGS data is housed in a centralized repository at NCBI Pathogen Detection website where NCBI conducts rapid analysis for QA/QC. The NCBI posts a daily tree for all species that recently have been uploaded. This way all of the data collected by these federal laboratories and their state and international partners are made publicly available for direct comparison. Numerous other international and academic laboratories also provide data to the NCBI centralized database. When isolates cluster together and appear to be closely related, the FDA works with CDC and USDA FSIS through the normal channels. The great benefit of combining food, environmental and clinical isolate genomes in a common database cannot be overstated.

Siragusa/Marshall: In the event of an outbreak, is it possible to obtain WGS’s from using a shotgun metagenome (a microbial and organismic profile obtain by sequencing all of the DNA in a sample, not just bacterial analysis of an enrichment thereby precluding isolation? (Refer to glossary; see Table 1)

Brown/Allard: Yes, preliminary research has documented the potential to obtain WGS data from cultural enrichments, saving the time it takes for full pure culture isolation, which potentially could provide time savings of two to five days depending on the pathogen. Having well characterized draft genomes such as those in the GenomeTrakr database will support rapid characterization from metagenomes after cultural enrichment. A future goal for the FDA is to transform and expand GenomeTrakr into metaGenomeTrakr to support either pure culture or enriched shotgun metagenomic samples.

Siragusa/Marshall: Is there any way that associated metadata tied to a strain (and hence its sequence) can be unmasked through legal action?

Brown/Allard: FDA protects confidential metadata collected during inspection just as it has always done with PFGE data. WGS data is protected at the same level as other types of subtyping information.

Siragusa/Marshall: Is the GenomeTrakr database associated with the GMI (Global Microbial Identifier)?

Brown/Allard: The GMI is a consortium of like-minded public health scientists who wish to collaborate to create a harmonized global system of DNA genome databases that is publicly available to promote a one-health approach. The GenomeTrakr is one of the databases that make up this larger effort that includes some data from members of the GMI.

Siragusa/Marshall: This column is meant to keep food safety professionals abreast of the latest knowledge, technology and uses of genomics for food safety and quality. Tell us your vision of how or which changes in technology (sequencing chemistry, bioinformatics, etc.) will be coming down the pike and how it might impact GenomeTrakr?

Brown/Allard: New technology has been constantly improving in WGS and in sequencing for the last 20 years, and there is no sign of this slowing down. Improvements continue to accrue in chemistry, equipment and software analysis. Likely future improvements will include more turnkey solutions for WGS from sample to report. This includes both DNA extraction and library preparation for sequencing, as well as data analysis pipelines (the system of analyzing the actual sequence data) that provide rapid, accurate and simple language results. Smaller mobile WGS devices are starting to show feasibility that would bring the lab to the samples and decrease the time to an answer (See: https://nanoporetech.com/products/minion) Metagenomics approaches appear to be maturing so that technology improvements are moving this out of a research phase and into direct applications. Currently MISeq (a commonly used workhorse nucleic acid sequencer made by the Illumina Co.) outputs are on the order of 300 base pair read lengths of nucleotides (i.e. A’s, T’s. C’s G’s), long read sequencing technologies, upwards of 1,500 base pairs may make analysis much easier so that more assembled and completed finished genomes are available in the databases. Cloud-based solutions of data analysis pipelines may provide simple solutions, giving wider access to rapid, validated data analysis and results. FDA researchers are working on all of these aspects of improvements in WGS technology as well as expanding the network to more global partners.

Siragusa/Marshall: Sequences deposited into GenBank (as part of GenomeTrakr) are accessible to anyone anywhere. Does this essentially usher in a whole new chapter in food microbiology especially at the pre-harvest level?

Brown/Allard: Yes, having well characterized reference genomes provided by GenomeTrakr partners will support microbial ecology and metagenomics studies. Metagenomics or microbiomes describing which species are present and what they may be doing in the ecology is providing new knowledge in all aspects of the farm to fork continuum. As the costs for these services decrease, we are seeing an increase in use to answer questions that have been impossible or extremely difficult in the past.

Siragusa/Marshall: GenomeTrakr is not a project per se; rather it is a program. How is it funded and will it continue on stable fiscal footing for the foreseeable future?

Brown/Allard: GenomeTrakr started as a research project in the Office of Regulatory Science in CFSAN, but much of this data collection is no longer research. Today, and for some time in the future, WGS at the FDA is collected as fully validated regulatory data to support outbreak and compliance investigations. As such, the FDA is in transition of moving WGS into a phase for more stable regulatory support. Research and development for future applications and technology exploration will always be a part of the FDA portfolio, although typically at lower funding levels than the regulatory offices. Public health funding is generally protected as everyone wants safe food.

Siragusa/Marshall: Are there any restrictions of isolate source? For instance, can isolates from poultry flocks or even wild birds be deposited?

Brown/Allard: The GenomeTrakr and NCBI pathogen detection databases are open to the public and thus there are no restrictions as long as the minimal metadata and QA and QC metrics are met. Current GenomeTrakr WGS foodborne pathogen data includes samples from both poultry and wild birds, as well as turtles, snakes and frogs. Members interested in what is in the database can go to the NCBI Pathogen Detection website and filter on simple words like avian, bird, gull, chicken, wheat, avocado, etc. An example is as follows for a snake.

Siragusa/Marshall: If a company deposits an isolate, will it have access to the GenomeTrakr derived sequence exclusively or at least initially for some period before that information becomes public?

Brown/Allard: No, currently the FDA does not hold WGS data. All data collected by the FDA is uploaded and released publicly at the GenomeTrakr bioprojects and at NCBI pathogen detection website with no delays. If companies wish to hold data then they need to look to third-party solutions for their needs. The reason that GenomeTrakr has been so successful is due to the real-time nature of the released information and that it is globally available.

Read on to page two below.

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