Tag Archives: FSMA

FDA Reflects on Monumental Effort of FSMA

By Food Safety Tech Staff
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Four years in the making and the FSMA implementation journey has begun. Michael Taylor, deputy commissioner for Watch Part II of Taylor’s speechfoods and veterinary medicine at FDA, describes, from a high-level perspective, what lies ahead in his first public speech since five of the seven rules were finalized. The following video is Part I of Taylor’s speech at the 2015 Food Safety Consortium conference.

Palmer Orlandi, FDA, Food Safety Consortium

FSMA and Laying Groundwork for Data Acceptance in Lab Partnerships

By Food Safety Tech Staff
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Palmer Orlandi, FDA, Food Safety Consortium

Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.

According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:

  • Mutual reliance on partners (federal, state and FDA)
  • Data-sharing capabilities (how data is generated and transmitted)
  • Acceptance of lab data

Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria at the 2015 Food Safety Consortium conference.

FSMA: Biggest Challenge is Preparation, Outbreaks Still to Come, Says FDA

By Maria Fontanazza
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FDA's Michael Taylor called the journey to FSMA an "amazingly robust process". (Click to enlarge)
FDA’s Michael Taylor called the journey to FSMA an “amazingly robust process”. VIEW VIDEO

FSMA isn’t about zero risk but rather minimizing the hazards, said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine at the opening of the Food Safety Consortium conference yesterday. “We have hundreds of thousands of businesses that are subjected to something that they weren’t before,” said Taylor. “The reality is, we’re still going to have outbreaks this year and the next year.”

In his first public speech since three final FSMA rules (on produce safety, foreign supplier verification, and accredited third-party certification) were filed on the Federal Register last week, Taylor shared some of the highs of the formation of the regulation as well as the challenges that are to come with implementation. “Many of us who were involved in the process 20 years ago didn’t imagine we’d get here today,” he said.

Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators.
Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators. (Click to enlarge)

Right now FDA is looking at the big picture challenge of preparing the agency and industry, and actually getting the work done. Taylor called the implementation challenge “enormous”, thanks to the significant scale of the food system, and said the import piece of the regulation will take the most hands on deck. The ultimate goal of FSMA is real-time prevention versus reaction, and the regulation will require a lot of change within FDA. According to Taylor, the agency is revamping its internal management processes, along with its training and orientation programs, which also includes food safety culture training. Other activities include restructuring the inspection and compliance approach by realigning its field force to have fully specialized teams of inspectors.

One of the challenges that industry sees is the mindset shift in investigators from a resolutions approach to a systematic approach in assessing systems. When asked how FDA will get investigators to this level, Taylor admitted he was a lot more worried about the issue than he is now. The district folks in the front line are enthusiastic about the new approach and feel empowered by FDA’s new mission, he said. And while he didn’t want to be a Pollyanna about the extent of the effort, FDA knows that the agency workforce will not be 100% aligned on day one of implementation and is managing the process with this awareness.

Voluntary compliance is key, and while the weight of ultimate accountability stands on the shoulders of food and beverage companies, success cannot happen without collaboration with FDA. “We are convinced we’ll get 90% of the job done by working with those who are committed to doing the right thing,” said Taylor. “When that fails, there are other ways to deal with that issue.”

Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium take a selfie to capture the "Kodak" moment.
Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium, take a selfie to capture the “Kodak” moment.

All images by amyBcreative photography.

Randy Fields, Repositrak
FST Soapbox

Dealing with FSMA’s Documentation Demands

By Randy Fields
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Randy Fields, Repositrak

With the signing of FSMA in 2011, wholesaler and retailer executives are now legally responsible for the safety of their supply chains. In addition, FSMA’s focus on prevention and its seven new rules requires retailers and wholesalers to collect, manage and store multiple documents from each vendor for compliance. These documents must be accessible upon FDA request within 24 hours and extend two years back. And here’s the kicker: Senior executives are now responsible for the compliance of their supply chain with FSMA.

At the Food Safety Consortium, Affiliated Foods Midwest (AFM) will talk about their preparation for FSMA compliance and decision to move away from their “home-built” and “highly manual” compliance system, which stored both soft and hard copies of vendor documents. With FSMA rules focused heavily on documenting preventive measures, AFM executive leadership assessed the company’s gaps and determined they needed to be more proactive.  John Grimes, director of safety for AFM, estimated that at the start of the company’s journey, about 30% of vendors were non-compliant with the three records they required: Certificates of Liability with specified limits, Hold Harmless forms and W-9s. 

“We knew compliance built on trust was not enough and wanted more business documents and regulatory records collected. We also needed to increase compliance, be more proactive, and so we were looking to automate our systems,” explains Grimes.

AFM decided to adopt the cloud-based Compliance Management System to proactively manage both business-related documents and FSMA-related records. Once implemented, the wholesaler’s non-compliance among vendors was reduced by 60% in the first 90 days through proactive alerts, automated exception reporting and focused, personal follow up. 

On Thursday, November 19, Randy Fields and John Grimes will discuss “FSMA Compliance Really Starts With Knowing Your Supply Chain” at the Food Safety Consortium. LEARN MORE“With our prior system I could find a requested document within 24 hours, but with the cloud-based compliance management system, I can pull it up and instantly share it with an FDA agent even before they have a chance to leave my office,” says Grimes.

Document management at AFM is now much more proactive vs. reactive.  The Compliance Management System automatically sends alerts to Grimes and the vendor when documents are missing, when insurance limits are too low, or when a document is due to expire. The system enables AFM to proactively manage more documents by vendor than ever before.   

The active approach that our staff enables its customers to take in managing compliance is really its differentiator. Each customer is provided with a dedicated team to reach out to their vendors to speed enrollment and quickly address their compliance issues.

According to Grimes, as more retailers and wholesalers adopt this type of system, the vendor community will move more quickly to embrace solutions that will help them comply with FSMA.

FSMA Final Rules on Produce Safety, FSVP and Accredited Third-Party Certification Out

By Food Safety Tech Staff
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Unpublished documents available on Federal Register; FDA to weigh in at next week’s Food Safety Consortium.

FDA has released its final FSMA rules on produce safety, foreign supplier verification programs (FSVP) and accredited third-party certification. The documents were filed today and are scheduled to be published on the Federal Register the day after Thanksgiving, Friday, November 27.

An agency alert called the finalization of the rules “groundbreaking”, as FDA takes “major steps to prevent foodborne illness”.

The final FSMA rules (unpublished documents) are available for download:

Next week’s Food Safety Consortium will feature several sessions dedicated to the discussion of these rules, including:

  • “Ask the FDA” Town Hall with Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine
  • Foreign Supplier Verification with Eric Putnam of Wixon, Inc. and Shawn Stevens of Food Industry Counsel, LLC
  • Compliance for Accredited Third Party Auditing with Trish Wester of PA Waster Consulting and Janet Raddatz of Sargento Foods, Inc.
Jacob Bowland, Heateflex
In the Food Lab

FSMA to Increase Role for Food Microbiology Testing Laboratories

By Jacob Bowland
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Jacob Bowland, Heateflex

As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.

Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities.  Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.

In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records.  Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility.  This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon.  LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.

In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs.  The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.

Debby Newslow

Strong Prerequisite Programs Half the Battle in FSMA Compliance

By Maria Fontanazza
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Debby Newslow

Having a strong prerequisite program is a key part of maintaining compliance with FSMA and food safety management systems standards. In a recent discussion with Food Safety Tech, Debby Newslow, president of DL Newslow & Associates gave a preview of some of the expertise that she will be sharing during her session at next week’s Food Safety Consortium, “Food Safety/HACCP Prerequisite Programs” (session takes place Thursday, November 19).

Food Safety Tech: What are some of the challenges that companies face in establishing prerequisite programs for HACCP?

Debby Newslow: Understanding the significance of the prerequisite program—a lot of times, employees are [going through the motions] of things like wearing hairnets or not wearing jewelry—but [they need to] understand why it’s important. There’s a weakness in the education of employees. We need to redefine the word “training”, because training should mean education, too and understanding the importance of it. Companies take it for granted—they have defined procedures that they may or may not follow. And the other challenge is commitment and an understanding from management as to why it’s important.

On Wednesday, November 18, Debby Newslow will participate in the Ask the Experts session, “Food Safety Training Challenges”. LEARN MOREFST: What are best practices that companies can implement in this area?

Newslow: They need a program established, along with commitment to and support from a food safety team that has a responsibility to the team to evaluate the effectiveness. They also need support from top management. Every group and department needs to understand their requirements and why they’re important. They need to have the tools and the knowledge to understand what’s needed. Through the food safety team or internal audit team they can have the independence to monitor and look at its effectiveness. A lot of companies hold strong that the auditors need to find everything that’s wrong, and that’s an old school way of thinking.

Educate everyone and encourage them to take ownership for compliance, and use the internal programs and teams to evaluate the effectiveness.

On Thursday, November 19, Debby Newslow will present, Food Safety Management Systems—Understanding the Three Legged Stool” LEARN MOREFST: What do you hope attendees gain from your session on food safety & HACCP PRPs at the Food Safety Consortium?

Newslow: My session is going to be focused on prerequisite programs and how they fit with FSMA and the preventive controls (they really go side-by-side)

  1. I want folks not to be so nervous about FSMA. If they have a strong program now for food safety and HACCP, and have the prerequisite programs identified and managed, they’ll be 95% there for FSMA [compliance]. Companies really need to focus on their internal programs and have a food safety program that is compliant with FSMA, and expand and confirm the effectiveness of these internal programs. Take pest control, for example. Some companies will hire the outside company and will monitor and know the effectiveness on a regular basis. Other companies will hire an outside firm and let them do whatever they want, and not have a clue what’s going on. Then there are smaller companies that have someone come in, spray, and send them a bill, and they won’t even know what the [outside] company is using as an insecticide. So you have different levels, and that’s why we have to understand each program and what is required for effectiveness and compliance.
  2. The role of the prerequisite program and preventive controls is that if you look at recalls in today’s world, 90% of recalls are caused from ineffective or nonexistent prerequisite programs [Newslow estimate]. Very seldom do we see a recall because a CCP fails. We get so hung up on other things and forget why do we take off our jewelry, for example. The odds of something going wrong are thin but when you look at it from the big picture, it can happen and it does happen. I’ll have some significant recent examples in my session.
Barbara Levin, SVP of Marketing & Customer Community, SafetyChain Software

SafetyChain Software Wraps 2015 Food Safety & Quality Enabling Technologies Series with More Than 2,000 Participants

By Barbara Levin
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Barbara Levin, SVP of Marketing & Customer Community, SafetyChain Software

SafetyChain Software recently announced the successful wrap-up of its online series, “FSQA Enabling Technologies – the Food Safety & Quality Assurance Game Changer.” Kicked off in January of 2015 and ending this past October, the series attracted more than 2,000 participants.

Known for offering a wide variety of complimentary online FSQA thought leadership events to the food industry – including its FSMA Fridays and GFSI in the Age of FSMA series – SafetyChain introduced the Enabling Technologies series to begin an important dialogue on the role of emerging technologies in managing key challenges faced by today’s food and beverage companies.

The complimentary series, which featured Leadership Forums, Tech Talks and eBriefs – many featuring recognized industry thought leaders as well as SafetyChain experts – is now available on-demand.

  • Series topics included:
  • Leveraging Technology for Best-in-Class Food Safety & Quality Operations
  • Tackling FSMA Compliance
  • Understanding and Managing Cost of Quality
  • Unleashing the Power of the Cloud on Food Safety & Quality
  • Conquering HACCP, HARPC and Food Safety Program Management
  • Tackling Food Safety Audits
  • The Critical Role of Technology on Today’s Food Safety and Quality Operations
  • FSQA on the Go – the Power of Food Safety & Quality Automation Mobile Applications

Dr. David Acheson, president of The Acheson Group and former Chief Medical Officer for USDA and Associate Commissioner for Foods at FDA – who kicked off the series with a leadership forum on Food Safety Risk Management and Supply Chain Controls, which also featured Nancy Wilson, Director of Quality Assurance, Risk and Safety for Wawa – commented, “With today’s global, complex food supply chain – and increasing regulatory requirements such as FDA’s FSMA – it is becoming increasingly difficult to manage risk while meeting operational KPIs using manual FSQA management systems.” Acheson continued, “There’s an important role for enabling technologies to increase operational efficiencies while sending safer food into commerce, and this was an important series to bring the food safety community into the discussion.”

Added Jill Bender, Vice President of Marketing Communications for SafetyChain, “SafetyChain is a recognized leader in offering online forums that provide insights, and facilitate discussions, on how the industry addresses challenges in sending safe, quality food into commerce – with more than 20,000 registrants for our events.  Deploying enabling automation technologies has become a vital strategy for improving FSQA, creating ROI and protecting brand from risk – and we wanted to promote meaningful dialogue on the impact of technology on key food safety and quality issues. We’re delighted that more than 2,000 safety, quality and operations professionals joined the conversation.”

Series Now Available On-Demand

To access the series’ complimentary Leadership Forums, Tech Talks and eBriefs, visit: www.safetychain.com/2015techseries

Rod Wheeler, The Global Food Defense Institute

Are Food Companies Prepared for Intentional Contamination?

By Maria Fontanazza
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Rod Wheeler, The Global Food Defense Institute

Unfortunately, quite often we are reminded of the vulnerabilities throughout the food supply chain. The latest E. coli outbreak linked to Chipotle restaurants in Oregon and Washington once again has consumers and the food safety industry on edge about traceability and a company’s ability to quickly identify the source of a serious outbreak. According to the CDC’s most recent update, laboratory testing is ongoing to find the DNA fingerprint of the bacteria. Concerning as this may be, no deaths have been reported thus far, but 42 people have been reported ill and 14 have been hospitalized in Washington and Oregon. In the most recent statement released on Chipotle’s website, the company said it is “aggressively” taking steps to address the problem, including by conducting deep cleaning and sanitization of its restaurants as well as environmental testing in its restaurants, and replacing all food items in the establishments that it closed “out of an abundance of caution”.

What if this were a situation of intentional contamination? Would Chipotle or any other company in this type of scenario really be prepared? These questions were posed by Rod Wheeler, CEO of The Global Food Defense Institute during a recent conversation with Food Safety Tech about food defense, and food tampering and intentional adulteration. Wheeler and Bruce Lesniak, president of Lesniak & Associates, shared their views on the threats that the food industry is facing and why companies need to have a strong plan in place to prepare for an attack on the food supply.

During next week’s Food Safety Consortium conference, Rod Wheeler will moderate the Ask the Experts session, “Engaging Food Tampering Discussion Surrounding Food Defense” on Wednesday, November 18.  LEARN MOREFood Safety Tech: What challenges do you see companies facing in the area of food tampering and adulteration?

Rod Wheeler: Our food supply is wide open. It accounts for 13% of the overall U.S. GDP. One thing we know about terrorists is that they want to affect our financial markets. What’s the best way to do that? You attack the 13% GDP – and what infrastructure is that? It’s our wireless systems, airline systems, transportation systems, medical supply, or our food and agricultural supply. Those are the top areas in which we need to focus, and we have to make sure the food & agriculture supply remains safe and secure in the United States.

On 9/11 the world changed, and the challenge for us becomes, within all of our 18 infrastructures, but how have we changed? Do we continue to do business the same way we always have, even prior to 9/11? Over the past few years, we’ve seen a significant increase in terroristic activity around the world—from France to Syria to Yemen to Pakistan. Here in the United States, we have to be mindful of what is happening.

Rod Wheeler, The Global Food Defense Institute
Rod Wheeler, CEO of The Global Food Defense Institute

We’ve always had food safety programs: HACCP, HARPC, GFSI, SQF, etc.—those are good for unintentional contamination. But what happens if someone wants to intentionally place a deadly contaminant into a product?

In this country, on a daily basis we see contaminations occurring.  We were recently notified of a massive outbreak of E. coli that has occurred throughout the Chipotle system: 47 Chipotle stores have been closed. What does that mean? Is that just a food safety issue? What if that E. coli could have been intentionally grown in a test tube and placed into the food supply? Going forward, we have a duty and an obligation to look at these things, not just at face value but think about whether they are intentional events.  

FST: Where are the biggest holes within food defense plans?

Wheeler: With more than 15 years of visiting food processing facilities, agricultural farms, dairy farms, and dairy processing facilities, the biggest concern that resonates with me is the fact that the culture of security is not there. The culture of security is simply security awareness—not planning. People in food plants are being taught to be mindful not vigilant. The largest of food companies have well thought out and active safety and defense plans, and their employees are educated, trained and empowered. We find that this falls off sharply with the mid-sized and small manufacturers and suppliers.  All food providers must have a comprehensive and strategic security plan that is active and measureable.

For example, let’s say a contractor is walking though a food plant. You have worked in that plant for five years but have never seen this person before. Would you question that person about their credentials? Are people thinking about the things they can personally do to reduce or mitigate the risk… are they empowered?

Darin Detwiler of STOP Foodborne Ilness, PCA sentencing
“When Someone Dies, It’s Not Business as Usual”: Darin Detwiler of STOP Foodborne Illness discusses the impact of the PCA sentencing on the food industry. Watch the video

So, the question is “what do you do when/if”: This is one of the topics we will be discussing at the [Food Safety Consortium] conference. It’s interesting that when we present this scenario to the management of a food company, many answer back with a blank stare. We ask, do you shut down your facility? Do you notify your customers? Do you notify the national media? This question goes to the root of the company’s security culture and the strength of its strategic planning. Until we develop the necessary plans, processes and protocols to respond proactively, we will continue to remain vulnerable.  

FST: Do you think many food companies assume something catastrophic won’t happen to them?

Wheeler: I always ask why it is that we don’t anticipate these things in advance. People are complacent. “It’s not going to have happen here,” they say. “What terrorist would come to our small town and do this? We’re just a small mom and pop [business].”

Recently, I received a call from a 17-employee company in Tennessee. This particular company processes honey for 100 large box retail stores. I received a call from the CEO who said, “My client wants us to have one of those vulnerability things.” He was referencing the vulnerability assessment. He said, “I don’t know why they’d want us to have one of those. We’re a small company down here in Tennessee, why does my client think some terrorist would come here?” The fact is, attackers will find the weakest link to attack: The small honey company is not the target; they are the vessel by which the attackers get to the primary target, and in this case, the big box retailer. The big box retailer/supplier is the target and the simplest, most effective way to get to them is through the hundreds of small, low to no protection suppliers.

These are the issues we need to enlighten and educate companies about; we need to get them thinking differently, because this way of thinking is completely different. If you ask someone who’s been in this industry for years, they’ll say, we never had to worry about locking our doors, or use biometrics to gain access to certain areas. We never had to think about these things in the Food & Ag supply before.

During our front line training course, we place a significant amount of focus on the food plant blending areas and why it is the number one threat area for intentional/unintentional contamination of our food supply in the United States. The blending area is exposed to a number of vulnerabilities and once attacked, the tainted ingredients are spread among numerous products that once distributed, are not necessarily quickly traced once they are blended into the final product.

Bruce Lesniak: The consequences of such an emergency are multifaceted; they affect the consumer and their product confidence, the manufacturer through recall and the retailer through recall, brand damage and loss of consumer loyalty. Often, this ripple effect begins with the small supplier and works its way upstream to affect the entire process.

We are seeing this scenario unfold in real time with Chipotle—this is huge in the food industry. FDA has not been able to determine exactly where that genetic fingerprint has originated resulting in location closures, shaken consumer confidence and brand damage. –Rod Wheeler

FST: What will it take the industry to wake up to what could become a serious reality?

Wheeler: Unfortunately it’s probably going to take a major incident for people to wake up and smell the coffee. With that said, we firmly believe that it is critical to awaken the sleeping giants before something happens. We must increase the awareness and provide education to heighten the reality of what can potentially happen and promote proactive engagement of risk mitigation.

FST: In the context of FSMA, are companies prepared for the compliance stage?

Wheeler: Over the years, I’ve seen a number of companies begin to ramp up security at their facilities. But a number of them are doing it because they realize they need to comply with the food defense elements of FSMA; the larger companies are driving compliance and are requiring that their suppliers comply. But I think convincing companies about “Why” this is important, is the challenge. Often times companies will say, “we’re doing this training”, or “we’re doing this vulnerability assessment because it’s a requirement of FSMA.”

We feel that if being compliant is your “Why “reason, then you are spending time and money for the entirely wrong reason. You don’t do vulnerability assessment or training in food defense because you want to comply with the law. You do it because you want to protect your company and the consumer from the reality of what can happen and proactively work to avoid a threat.

Lesniak: We see the adoption trend take hold as it has traditionally, in three phases. First are the early adopters—they understand the importance of compliance for the right reasons and the need for food defense, Second are those who feel the urgency to comply due to a compelling issues (an incident or have been instructed to do so by larger suppliers in order to retain contracts), and third are those who will come kicking and screaming.

Wheeler: A lot of the requirements of FSMA were generated as a result of the PCA event in 2009. The prosecution and subsequent conviction of the Parnell brothers isn’t the last prosecution we’re going to see for someone violating a food safety protocol. This is the first, and it’s a wake up call.

SVP, Food Safety, United Fresh Product Association
FST Soapbox

GFSI and FDA’s Preventive Controls: Complementary or Redundant?

By Jennifer McEntire, Ph.D.
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SVP, Food Safety, United Fresh Product Association

Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?

Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference.  LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?

Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.

The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”.  FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.

When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.

To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.

Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.

So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment.  And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.