Tag Archives: FSMA

What Constitutes a Successful FDA Audit?

By Sangita Viswanathan
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From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the auditing process?

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, an expert team from The Acheson Group, comprised of Melanie Neumann, J.D., M.S., VP and Chief Financial Officer; Jennifer McEntire, Ph.D., VP and Chief Scientific Officer; Anne Sherod, M.S., Director of Food Safety and Valerie Scheidt, MBA, CP-FS, Director of Food Safety, answered key questions on conducting successful FDA audits. We present some excerpts below.  

How does the FSMA third party audit accreditation rule impact the audit process?


The purpose of the third party accreditation and certification audit is to issue a certificate for high risk foods or the voluntary qualified importer program. The main foundation of the standards that FDA is setting will come from the human preventative controls rule, the animal preventative controls rule, and the produce safety rule. Some standards may also come from the sanitary transportation rule and food defense rule. FDA will be appointing an accreditation body and this accreditation body will approve and monitor certifying bodies (CB). These CBs can be private companies or private individuals who will be authorized by the accreditation body to perform the audits and issue those certifications. 

Foreign governments can also be approved by FDA to act as a CB. Right now only New Zealand is approved and FDA is looking at approving Canada. We don’t anticipate any other country to be approved in the near future.;

Certifying bodies will have strict conflict of interest and reporting requirements to FDA. CBs must report to FDA within 45 days even if they’re just performing a consultative audit. They must also report to FDA if they see an issue that could lead to a Class I or Class II recall and they have to report to FDA before they report to the company that they are auditing.


Will a GFSI audit satisfy FSMA audit requirements?

GFSI audit requirements do not match the FSMA audit requirements, but they are not too different. Several of the schemes are very similar, and each scheme owner is making a concerted effort to become FSMA compliant. If an auditor is doing a GFSI audit, they do not need report to FDA before the company. The FSMA requirements of avoiding conflicts of interest, record keeping, and training may deter GFSI auditors from becoming Certifying bodies under FSMA. Unless FDA offers an incentive, there will be a shortage of FSMA CB auditors. 


What are the elements of a successful audit?

The number one goal of an audit is to identify risk. The audit needs to accurately describe the non-conformances against the audit standard to give your quality and operations team reliable and actionable data so they can mitigate that risk. The relationship between the auditor and the facility should be a partnership, add value, and build trust. The facility should learn from the auditor and the auditor should understand what the facility is doing to mitigate risk and promote food safety. Continuous improvement takes the feedback from the non-conformances and evaluates them against the organization’s goal around risk. Whether the results are from an announced, unannounced, internal, second, or third-party audit, continuous improvement is critical, and this requires commitment from management and will help the facility become audit ready. 


How can I ensure my auditor is up to the task?

Most audits use checklists. This goes for both the auditor and the audited. The checklist provides a standardized list of what’s expected and adds an element of order and control to the audit. It also allows for an effective way to quantify metrics. 

However, using a checklist alone can lead to minimum risk finding. The auditor needs to find a balance between being strategic and prescriptive. In order to be effective, audit protocols need to be periodically reviewed and updated. This is especially relevant with FSMA and holds true for internal and third-party audits. Check to see if the auditor’s checklist is pre-FSMA or post-FSMA. Ask the auditor when was the last time that they reviewed and updated their audit protocols. 


Will we have enough good auditors to meet the need?

No, we already don’t have enough good auditors. The implications of this are that we may get substandard audits from substandard auditors. The current model isn’t working and we need a new approach. Currently, most auditors have extensive prior experience working in industry and often become auditors after they retire.

We are creating auditors not through structured training. This model is not sustainable and has limited growth potential. It will not provide the level of training required for GFSI or FDA third party certification requirement. We need a training program for auditors who come right out of school. We need people to go to school for food safety and be able to become an auditor after graduation. Food safety needs to be incentivized at the university level. There should be a bachelors degree in food safety auditing. We need structured training and developmental opportunities for folks earlier in their career rather creating auditors at the end of their career.

Training in the Food Safety Industry

By Sangita Viswanathan
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Dr. John Surak food safety trainer and Warren Hojnaki of SGS talk about trends they see in food safety training, areas of focus, how to keep training relevant and useful, and what they are expecting to see in the future.

FDA, FSMA, FSMS, HACCP, GFSI, BRC, SQF, IFS, FSSC… The food safety sector is a cornucopia of new regulations, abbreviations and standards. Helping navigate this maze are food safety training courses and the instructors. However, the success of training programs depends on how applicable these courses and the curriculum are to the industry and the specific client, and how experienced and knowledgeable the instructor is in understanding current regulations, specifications of standards, hazard profiles and compliance requirements of that client. 

In an interview with FoodSafetyTech.com, Dr. John Surak, food safety trainer, and Warren Hojnaki of SGS, talk about trends they see in food safety training, areas of focus, how to keep training relevant and useful, and what they are expecting to see in the future.

John Surak, Ph.D., is principal of Surak and Associates, a full service food safety and quality consulting service. He works with the food processing industry in developing food safety and quality management systems, designing and implementing process control systems, and implementing Six Sigma and business analytics systems. Warren Hojnacki is Training Manager, for SGS North America. His department delivers training services for North American clients. 

FoodSafetyTech.com: What are some broad trends in food safety training that you are noticing?
Hojnacki: What we are seeing is a lot of clients needing foundational training. For instance, our most popular training programs are still HACCP, implementation for FSSC 22000, SQF etc. On the other side, clients are still very confused about what they should do regarding new and proposed food safety regulations. While they are following the directives that they receive from their customers, currently there still is a wait-and-see mentality. 

Dr. Surak: I notice the focus on food safety moving up the food chain. About 5 to 7 years ago, our primary clients for food safety training programs were food processing companies. Now our clients are suppliers to these companies as food companies are pushing the requirement for training on them. These supplier companies then need to make decisions on what schemes they want to be certified under. Most of the time, the customer accepts any GFSI-recognized scheme, but sometimes the customer names a specific scheme. Different GFSI schemes have different sweet spots and advantages. They all assume different knowledge about food safety and some are more prescriptive than the others. Clients have to figure out which scheme would be the best fit for them. 

FST: What kind of training courses are most popular, most asked for?
Hojnacki: When clients and companies decide on getting audited or certified against a particular food safety standard, training for that standard is a common requirement. Auditors specifically want to be trained to build their skill level, whether it’s getting trained for HACCP or FSSC 22000. A number of our clients also come to us saying that when they have a 3rd party audit, the most common non-conformances pertain to a less than robust internal audit system, so auditor training is a critical area that our clients ask for. 

Dr Surak: One of the biggest aspects of training that I try to focus on is lead auditor training. This course is designed to help an individual get certified in a particular audit scheme. We cover the same information for internal auditor training. However, the difference in this case is that for the internal auditor, the goal is to get his company certified. If a company has a strong internal auditor, they can reap substantial benefits. We also focus on, as part of our training, doing mock audits. This is more than going into a course or workshop and giving a lecture. For mock audits, you are put into a spot where you have to make real decisions on the floor. When we conduct such practice audits with our clients, in addition to our regular food safety training courses, we find a high level of involvement and interaction from the attendees and appreciation from the client. 

FST: What are some of the gaps in the training that you notice?
Hojnacki: What we see in general is people not covering the topic in-depth enough. Many training courses (outside those offered by SGS) seem to cover the topic in a very superficial manner and this doesn’t help. 

Dr. Surak: Many of the attendees who come to an audit training class have never taken the time to familiarize themselves with the standard. So what you are doing in that time is teaching them the standard and then teaching them how to audit. If the participants already know the standard, then you focus on just reviewing the standard and cover how to go about doing the audit. 

FST: What are some common questions attendees ask at ‘implementation/auditor’ training?
Hojnacki: Attendees very much want to know application to their respective situation. As an auditor, you need to know the right open-ended questions to ask when you are conducting an internal audit, and in our training, we provide examples for that. 

Dr. Surak: Our training focuses on enabling auditors to get the participant in a conversation and be able to answer questions during an audit. We are not in the business of writing traffic tickets, we are out to assess if the food safety system meets the standard, and also to identify the areas where it needs to be strengthened. Things that participants typically want to know are, going into a 3rd party audit, what is the auditor going to do? How is he going to react? And how can they present themselves in the best possible way to have a good audit? Also the instructor or auditor needs to understand the differences in the standards and the different hazards. There are unique challenges for different suppliers – or where along the supply chain they are, for instance are they a retailer, a supplier or a processor. It’s not a one size fits all situation. If you are looking at ingredient suppliers, the hazards are very different than what a retailer would be looking at, for instance. 

FST: How do you identify the best training company or program for you?
Hojnacki: We go through this everyday with every client call and we understand that we are not the only resource, our clients have several options. We first evaluate the trainer to understand what’s their educational and work experience background? Does it correlate to the industry you are in? Are they practitioners or just theorists? Food industry is a very big growth area right now, and we are seeing a proliferation of tutors coming into this field. Some of them have varied backgrounds, such as in automobile or aerospace industry. Often times, clients will make a decision based on prices quoted, and then realize that it didn’t work out the way they had anticipated. We (SGS) have often had to go to that client and redo things. Today, more than ever, the decision to choose a trainer/ training vendor, needs to be based on their competence, experience, and skills. 

Dr. Surak: I was recently at a client where they had completed certification training. When I asked to see the materials and bios of the instructor, I noticed that he had no prior experience in the food industry. I wondered how you could teach internal auditing in a food processing industry if you did not know about food processing! It’s imperative that clients look at the trainer’s background and experience. 

FST: Food safety training in 2015 – what will change?
Hojnacki: Food safety training curriculum will have to increasingly show greater applicability to clients to meet their needs. It has to be a round peg and in a round hole type of situation. Especially with FSMA rules getting finalized, clients are going to expect more out of their training. They are going to expect their instructors to be a resource, and to be up to date on the respective regulations and be able to tell clients how these rules will apply to them, and what they need to do differently. 

Dr. Surak: Processors are going to ask questions such as ‘I am certified to a GFSI scheme, so now do I have to do anything additional to meet new requirements’ or ‘are there areas where we have done some basic groundwork, and we have to raise the bar higher because of new regulations,’ and trainers need to be able to answer these.

FSMA Sanitary Transport Rule: What You Need to Know

By Michael Biros
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Who does the proposed Sanitary Transport rule apply to and what will be its impact on the various transportation industries? This Q&A offers some insights and key takeaways from the critical rule.

On January 31, 2014, FDA announced the “Sanitary Transportation of Human and Animal Food” rule which will require certain shippers, receivers and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. The proposed rule establishes requirements for vehicle and transportation equipment, transportation operations, the exchange of information, training, written procedures and records. The proposed FSMA rule is broad and comprehensive and will likely have far-reaching effects across the food transportation industry.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Melanie Neumann and Jennifer McEntire, from The Acheson Group, answered some questions about the extent and implications of this rule.  We present some excerpts below. 

Who does the Sanitary Transport rule apply to?

Compared to other FSMA rules, the Sanitary Transport Rule’s coverage is broad and comprehensive. It will apply to businesses regulated not just by FDA, but by USDA as well. It will apply to food for human consumption as well as animal consumption. It will apply to both intrastate and interstate commerce. 

However there are a few exemptions: Companies with annual sales less than $500,000 and foods that are fully packaged and shelf stable are exempt. 

What impact will this proposed rule have on various transportation industries?

When it comes to Shippers and Carriers, this rule will affect everyone. Shippers need to establish and communicate with carriers about specific conditions for the food such as temperature control, cross-contamination control, hand-washing facilities for loading and unloading, etc. Carriers need to ensure that they are meeting the shipper’s requirements. They need to make sure equipment is appropriate and clean. Like other FSMA rules, this rule will require documentation. Carriers also need to complete a fair amount of training to establish how they can achieve these expectations. 

Receivers, historically, haven’t had a lot of responsibility in ensuring sanitary food transport. Now they have a regulatory obligation to do so. This rule will apply to anyone receiving food including retailers, food service, and small convenience stores. They will be required to actively participate and are subject to more regulatory oversight than they have had ever before. 

What is a waiver in the context of this rule and who might be eligible?

There are opportunities to receive a waiver and waive out of this rule. Those who qualify for a waiver are those who can prove that they are under other practices, protocols, and ordinances that ensure safe transportation of the food. For instance, businesses that transport USDA Grade-A dairy and pasteurized milk may qualify for a waiver. 

What are some key takeaways about the Sanitary Transportation Rule?

A lot of industry members have already implemented many of the best management practices that will be mandated by the proposed rule. Companies will need to focus on documentation and training. Companies will need to develop procedures to communicate requirements across shippers, carriers, and receivers. They will also need to develop training regimens and validation systems to ensure that these requirements are being met. Documentation is critical. In the eyes of a regulator, if it isn’t documented, it didn’t happen.

More information visit www.SafetyChain.com/FSMA-Fridays.

Food Defense Rule – What You Need to Know

By Food Safety Tech Staff
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What is the Food Defense rule and how is it different from the Preventive Controls rule proposed under FSMA?

On December 24, 2013, the U.S. Food and Drug Administration proposed the Rule for Focused Mitigation Strategies to Protect Food against Intentional Adulteration under the Food Safety Modernization Act

Also known as the food defense rule, the proposed rule would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm, and would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation. Comments are due by end of the month.

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, Dr. David Acheson, and Melanie Neumann of The Acheson Group discussed this rule. We present some excerpts below). 

Who does the Food Defense rule apply to?

The goal of this rule is to put preventive controls in place where terrorism is a threat. By making this rule risk-based, FDA aims to prevent a single-point attack with potential mass casualties. This rule is focused on large manufacturers and processors of human food with sales of over $10 million. It will not affect small manufacturers or farmers with the exception of dairy operations and bulk liquids. 

If the rule applies to you, what do you need to do?

Assemble a food defense team with industry experts and come up with a food defense plan. Conduct vulnerability assessments. Think about the possible agents and the processes whereby that agent could be added to one of your foods. What are your actionable process steps and mitigation strategies? For instance, how can you control access to bulk liquids and bulk mixing? The food defense plan does not need to be validated, but it does call for training, monitoring, and documentation. 

What are the similarities and differences between Preventive Controls and Food Defense rules?

Unlike Preventive Controls rules, there is no need to validate that the Food Defense mitigation strategies are effective. Also, if you’re doing your own vulnerability assessment, you need to have someone who knows what they’re doing, but they don’t need to be a ‘qualified individual’ as required under the Preventive Controls rule. Another distinction is that with Food Defense, there’s no assumption that the food you produce is automatically adulterated if there are problems with your mitigation strategy.

How will I know if my Food Defense approach is effective?

It is impossible to know if a food defense strategy is effective without challenging the system. It is highly unlikely that FDA will simulate an attack to gauge Food Defense effectiveness. Even though the likelihood of a terrorist attack on the food supply is rare, the industry must go through due diligence to try to prevent attacks from happening. It is not enough to have a security camera in place if that camera doesn’t work or if no one is monitoring it. 


This rule will not be finalized until Spring of 2016. FDA wants comments from industry on Food Defense and on how it can be shaped into a practical and economically feasible program. 

Where does economically motivated adulteration fit into this?

FDA is covering economically motivated adulteration with the Preventative Controls rule, not Food Defense. There has been a lot of controversy regarding this decision. Where does precedent lead to a reasonably likely event to control? If the scope is not limited, this could require an excessive amount of testing for many different compounds in incoming ingredients with significant economic impact. 

More information visit www.SafetyChain.com/FSMA-Fridays. 

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EQMS and HACCP – Friends or Foes?

By Kelly Kuchinski
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How quality processes can allow companies to take a more preventative approach to product recalls.

HAACP4 300x281 EQMS and HACCP Friends or Foes?I recently spoke to a friend who was a plant manager at a food manufacturing company, and he is all too familiar with today’s manufacturing challenges and product quality issues. We discussed how quality processes allow companies to take a more preventative approach to product recalls. He agreed that if quality and regulatory requirements are met before a product leaves the facility, organizations can be sure that they are providing safe product to their customers. The ability to identify issues before a product is distributed can also reduce additional costs associated with product recalls and the impact on a brand’s reputation and sales.

We then discussed how important HACCP was to his team. Hazard Analysis and Critical Control Points (HACCP) is a process control system that identifies where hazards might occur during the food production process and puts actions into place to prevent such hazards from occurring. By monitoring and controlling each step of the process, there is less chance for contamination or other hazards to occur.

He shared a story on his first experience implementing a HACCP plan at his previous facility. He noticed key areas where sanitation standards were not being met so he identified necessary corrective actions required to keep finished product safe. The process of monitoring these changes was difficult to manage and was draining the already limited resources in the plant.

During a team meeting, he brought up the issue and the QA Director mentioned that they were using a quality management system that managed workflow processes. They discussed how CAPA and complaint management were key processes that they were using in the QA area and it would easily support corrective actions associated with HACCP.

Within a few days, they were able to setup the system to support his team and automate the process. The most notable difference in using the QMS software was the time savings and reduction in recording errors. The system provided an interface that was easy to use and provided drop down menus for easier navigation through the system, unlike the cryptograms needed to use their ERP system.

As we finished up our call, we agreed that the true benefit of a quality system is visibility. We can now monitor potential hazards in the facility, manage outside supplier and third party manufacturers, and track compliance with regulatory requirements across the enterprise using one centralized system.  It is this visibility across the organization and its supplier network that allows organizations to tie in multiple quality controls, regulatory requirements and HACCP processes to automate and maintain the record of any change and preventative action to ensure consistency and safety of all finished products.

With companies encountering spikes in unforecasted demand, new levels of regulatory scrutiny, and fewer resources than ever before, my friend and I agreed that EQMS systems are more crucial than ever to help manage the complexities of quality process and allow issues to be resolved when they are identified early on.

About the Blogger:

Kelly Kuchinski, Industry Solutions Director at Sparta Systems, has 20 years of product management and marketing experience with a focus on consumer packaged goods, chemicals, life sciences and technology. Prior to joining Sparta Systems, Kelly focused on developing products and solutions to support companies across multiple industries to enhance functionality, increase efficiencies and reduce costs. She held product management and marketing positions at Merck Chemical, GS1, Checkpoint Systems and GE Capital. Kelly has an MBA from LaSalle University and received her Six Sigma Green Belt certification while at GE Capital.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

To Test Or Not To Test?

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

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

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

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

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

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

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

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

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

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

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

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Food Safety Labeling – Putting Rare Steak On The Chopping Block

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

Like most people, I enjoy a good steak.  

I have also found that, in recent years, my options for good, quality steaks have increased significantly, as food processors and restaurant chains look for ways to distinguish themselves and their products. Industry has moved toward more value-added products, such as mechanically tenderized steaks, using needles to soften the meat and even to inject marinade. Indeed, I think it would be safe to say that the vast majority of steaks now consumed in restaurants are mechanically tenderized.

The use of such technologies, however, creates additional food safety challenges not present in non-tenderized products. This is because, to the extent there is any possible pathogenic contamination present on the exterior of a steak, the process of mechanical tenderization can push that contamination deep into the product, where it becomes more difficult to destroy through cooking.

With that backdrop, the U.S. Department of Agriculture is now becoming more involved in helping educate end-users on the risks associated with mechanically tenderized products. In particular, USDA has published new proposed rules requiring meat processors to properly label any mechanically tenderized meat products they sell. These new rules will likely have two effects: (1) they may make mechanically-tenderized rare or medium rare steaks nearly impossible to sell; and (2) they may drive the vast majority of these products out of the food service market.  

Here’s why. In addition to requiring processors to label these products as “mechanically tenderized,” USDA will also require processors to include validated cooking instructions which, if followed, will ensure that any harmful pathogens in these products are destroyed. The question, then, for industry will be whether cooking mechanically tenderized steaks to the higher temperatures needed to kill foodborne pathogens will prevent them in most cases from being served “rare” or even “medium rare.”  

To justify its new rules, USDA has cited a number of recent outbreaks caused by mechanically tenderized steaks. According to USDA, since the year 2000, there have been a total of six E. coli O157:H7 foodborne illness outbreaks attributable to mechanically tenderized steaks served in restaurants and consumer homes. These six outbreaks, spanning 13 years, have included a total of 176 confirmed E. coli O157:H7 cases that resulted in 32 hospitalizations and 4 cases of HUS (acute renal failure).  

While you can decide for yourself whether such a substantial change in the labeling of steak products is warranted by the fewer than 15 cases reported annually since 2000, what we do know is that the labeling rules are changing fast, and serving mechanically-tenderized medium rare steaks in restaurants may no longer be a legal option. Time (and temperature), of course, will tell. Ultimately, this is because whether the term “medium rare” survives will depend upon the validation studies governing any new labeling. USDA’s rules will require validated instructions to include, at a minimum: (1) the method of cooking; (2) a minimum internal temperature validated to ensure that potential pathogens are destroyed throughout the product; (3) whether the product needs to be held for a specified time at that temperature before consumption; and (4) an instruction that the internal temperature should be measured by the use of a thermometer. 

In turn, processors will need to demonstrate to USDA that the instructions are also “scientifically supported,” meaning they must demonstrate that: (a) the cooking instructions can repeatedly achieve the desired minimum internal temperature and, if applicable, rest time; and (b) the minimum internal time and, if applicable, rest time achieved by the instructions will ensure that the product is fully cooked to a level designed to destroy any potential pathogens throughout the product. On the other side of the coin, even if processors could properly validate their cooking instructions, it may be that we see some major restaurant chains shift away from using these products altogether.

Indeed, once the new labeling requirements go into effect, then restaurants will have a difficult decision to make: comply with the labeling instructions, or ignore them?Responsible restaurant chains will, of course, determine that they need to comply with the instructional labels. This is because the instructions, themselves, anticipate (or, at least warn) that the product at issue could possibly contain pathogens and thus must be cooked to a predetermined temperature in order to render that product safe for consumption. If those instructions are ignored, however, and a customer becomes sick (or, even dies, as a result), that company could be exposed to significant punitive damages for disregarding a known risk. Thus, the only responsible course will be to either:  (1) refine internal policy to ensure that all such products are cooked to the recommended temperatures; or (2) to purchase steaks that are not mechanically or needle tenderized. There really will be no other options.

So, the most likely longer term result, in my opinion, may be that the restaurant industry will begin to move away from needle or mechanically-tenderized products, unless and until those products can be subjected to processing interventions (like irradiation) that will allow the end users to prepare and then serve them somewhere south of well-done.  

So, if you like selling or serving (or, I suppose, eating) steaks that can be cooked medium rare, you may want to watch these new rules closely. In in the end, “medium rare” may become much more rare you think.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Brand Protection Requires More Than Wishful Thinking

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

We have learned in recent years that, if you work in the food industry, it’s not a matter of “if” your products will be associated with a recall, it’s really a matter of “when.”

Indeed, lurking somewhere in the darkest corner of a hot box, in the silent throes of a sales cooler, or in a case-ready package being staged for delivery, there are a few colonies of pathogenic bacteria waiting patiently for their chance to wreak havoc in our business and lives.

For more than a decade, our firm has worked closely helping the meat industry with crisis management, regulatory response and complex litigation following large-scale outbreaks and recalls. The unfortunate reality from a business perspective is that, in a disturbing number of instances, when outbreaks and recalls occur, the companies that are involved cease to exist.

Watching innumerable outbreaks unfold over the years, our firm has gained a deep understanding about the science of food safety, the epidemiology of foodborne illness outbreaks and the legal consequences of food product recalls.

We have also gained far-reaching experience analyzing why recalls occur in the first instance, and how they, in many instances, could have been avoided.

While all companies want their customers to believe that their products are as safe as possible, and try to communicate this fundamental message through their brand, in today’s world success requires more than just a good advertising campaign. In order so sell food safely, a company needs to demonstrate it can process a safe product. In order to process a safe product, the company needs to invest in making it a reality.

Food safety, unfortunately, doesn’t just “happen” by itself.

In addition to facilitating their own third party audits, and also ensuring they are maintaining regulatory compliance, companies should also be auditing their operations from a brand protection standpoint. When I conduct Brand Protection Audits on behalf of my clients, I can usually accomplish what I need in just a single day. I like to interview employees, learn about the company’s food safety culture, and review food safety training and operational materials. I will also assess a company’s written food safety plans, identify hidden gaps that create additional exposure, and suggest improvements that will avoid criticism by lawyers or media in the event of an outbreak or recall. Moreover, many companies are surprised to find out that their policies are not actually being executed as written.

In addition, companies can lessen their exposure (and, thus better protect their brand) in other ways as well. Working together, we can easily develop stronger and more effective supplier specifications and indemnity agreements that provide added protection, as well as ensuring that existing insurance coverage is sufficient to cover potential liabilities. We also work closely with companies to develop crisis plans and conduct mock recall training, in as close to a real-world scenario as possible, to improve their ability to trace, contain and effectively manage potential problems.

Finally, we help our clients respond to FDA Warning Letters (and 483s), as well as FSIS issued NRs (so as to avoid criticisms months or years later from a judge or jury), and also prepare for and respond to both routine and for cause Food Safety Assessments. Many companies simply do not realize that what they say today can (and always will) be used against them tomorrow.

With that said, merely creating the “image” that you care about food safety is no longer enough. History has taught us that by taking a few additional proactive steps right now, such as auditing the true depth and survivability of your brand (i.e., the Brand Protection Audit), companies can significantly and strengthen the trust in, and longevity of, their most important assets – their image and their brand.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

The Food Safety Modernization Act for Dummies (Part 2)

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

In my previous column, I introduced the novel concept that achieving compliance under FSMA can in many ways be really quite simple.

Indeed, in its most basic form, FSMA mandates only a handful of requirements. If you are a food company, and if you source your ingredients domestically, you will only be required to show that you have:

  1. A written food safety plan;
  2. Records to prove that you are following your written food safety plan; and
  3. A traceability system in place (or, stated differently, that you have records to demonstrate where your ingredients came from, the products in which your ingredients were used, and the customers to whom your resulting finished products were sold).

In turn, the key to actually demonstrating compliance to FDA (when FDA visits your facility to perform its first FSMA inspection), is to craft your FSMA materials so that they are aligned as closely as possible with what the FDA will “expect” to see.

The cornerstone of FSMA is the development of a written food safety plan. To create your written plan, you will need to conduct a food safety assessment within your facility, identify those food safety hazards that are reasonably likely to occur within your products, and then develop and implement controls (i.e., critical control points) designed to manage those hazards.

It is important to note that the controls you identify will need to be proven effective (i.e., validation), and you will need to create and maintain monitoring records that will prove that your controls are working as intended (i.e., verification). You will also need to develop prerequisite programs designed to ensure that you are following good manufacturing practices, that your employees are following hygienic practices, and that your facility remains clean. Although you can actually write the first draft of your plan, it will ultimately need to be approved by a “qualified individual.” We, of course, can help you there.

To establish compliance under FSMA, companies will also need to adopt a robust traceability system. From a food safety standpoint, it will be very important in the eyes of FDA that all companies be able to identify the source of their incoming ingredients, the specific products in which those ingredients were used, and the companies to whom the resulting finished products were sent. This way, if there is a downstream problem associated with a product, FDA can immediately trace the product back upstream, and then quickly identify, contain and solve any potential problems.

So long as your program enables you to accurately and quickly accomplish these goals, FDA will likely characterize your program as compliant.

Next, if you do decide to source any food ingredients from foreign suppliers, you will also need to ensure that those suppliers are complying with each of the FSMA requirements as well. You can demonstrate compliance under FSMA by having a copy of your supplier’s written food safety plan (developed by a qualified individual) in your file. I would also recommend having your foreign suppliers audited annually, and performing some type of microbiological testing to verify the effectiveness of their programs and the quality of the products they are shipping. Also remember, both your plan and your supplier’s plan will need to be reassessed any time there is a change in any manufacturing process, or at least once annually, whichever comes first.

Finally, although this column represents the essence of FSMA, I would not be doing my job as a lawyer if I did not at least offer the following disclaimer: There are at least a few finer rules contained within FSMA not specifically addressed in this column and, regardless of where they are hidden, all of the rules are and will be changing routinely. Thus, as you work to develop your plan, it will be critical to read the Act and ensure you understand each of the Federal requirements and FDA’s corresponding expectations.

But, we, of course, can help with that too. So, as you march forward toward compliance, rest assured, it really can be quite simple. Yes, you CAN develop a written food safety plan and chew gum at the same time … just don’t do it on the production floor.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

The Food Safety Modernization Act for Dummies (Part 1)

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

There has been a lot written in recent months about the perceived complexities of the Food Safety Modernization Act (FSMA). The new requirements are broad and onerous, stakeholders complain. The proposed rules will be burdensome and costly, experts predict. And FDA enforcement will be varied and inconsistent, others warn. And, yes, even I have been at least partially guilty (I will reluctantly admit) of adding my own voice to the growing chorus detailing all the unfavorable features of FSMA.

But, as I continued to think about the problem, I quickly began to realize that none of this commentary is overly helpful for the business owner simply trying to achieve compliance. Most companies don’t really care about listening to experts pontificate endlessly (which has been going on months and, in some instances, years). Instead, most companies just want to be told what they need to do. So, with that in mind, I thought it would be helpful if we started with a blank canvas, and approached FSMA from a different angle. FSMA for Dummies – or, compliance made simple.

To start out, let’s be clear, the general principles underlying FSMA are really quite easy to grasp. In its most basic form, FSMA requires companies to make safe food. Duh.

Second, food companies shouldn’t be misled about the difficulty of compliance. How a company goes about making safe food is, well, with just a few exceptions, left up to the company itself.

So far, so good? I hope so. It’s not very difficult.

Next, to actually demonstrate to FDA that a company has achieved compliance, a food company needs only to understand what the FDA inspectors will want to see when they show up at the company’s door. Here too, the answer is very simple. Generally speaking, if you process food products using ingredients sourced from suppliers in the U.S., there will be three basic requirements.

First, you will need to show FDA inspectors that you have a written food safety plan. Second, you will need to show the inspectors the records that you have created which prove you have been following your written food safety plan. And third, you will simply need to show the inspectors where your ingredients came from, the products in which those ingredients were used, and your customer to whom you shipped them. If you process foods using ingredients sourced from overseas, you will also need to have a folder in your file cabinet (or on your computer) called “foreign supplier verification program.” We will talk about what exactly FDA will want to see in that folder in our next column.

So, when it comes to FSMA, try to discount any forecasts of rough seas or dark clouds. Instead, embrace the idea that complying with FSMA can be very straightforward and easy.

And, with that footing, I will detail, in my next column, the basic steps companies can take to meet the three (or, maybe four) basic requirements listed above.

Yes, it is possible, even dummies can do FSMA.