Deirdre Schlunegger, STOP Foodborne Illness
Food Safety Culture Club

Join the Club

By Deirdre Schlunegger
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Deirdre Schlunegger, STOP Foodborne Illness
 
Deirdre Schlunegger, CEO of STOP Foodborne Illness 

What is the Food Safety Culture Club and what does it mean?  Long before it was trending, STOP Foodborne Illness was talking about and cultivating food safety culture. We intimately know and share the compelling reasons, along with the “Why” behind food safety. Statistics without stories are not compelling. By hearing the stories and seeing the faces of those who have been ill or who have lost loved ones, the reason for a food safety culture is remembered—and these memories may translate into everyday food safety practices. Everyone has a role in food safety but for some, the only role was to become ill.  Think about cantaloupe, peanut butter, ice cream, pre-washed greens, candy apples and more.

Why should you care?  We are all consumers; we all have children, parents, friends and loved ones who we do not want to become ill from a preventable illness. No one wants for individuals to contract a foodborne illness.

So here we are, on a journey towards creating strong food safety culture in the lives of business leaders, the food industry, employees handling food, and in our schools and homes. I recently attended several conferences that had themes and program titles related to “A Food Safety Culture”. We know it is critical for leaders to embrace the culture, model safe and best practices, and we know it is important to share the reasons why.

In this column, I will talk about summer food safety, back to school food safety, the importance of hand washing, and many other Food Safety Culture Club topics.  

You are a significant contributor in keeping food safe; you make a difference.

STOP Foodborne Illness is a national nonprofit organization dedicated to preventing illness and death from foodborne illness by advocating for sound public policy, building public awareness, and assisting those impacted by foodborne illness. Contact STOP Foodborne Illness if you are interested in having one of the staff members or board members speak at your training.

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

How the Blue Bell 483 Inspection Reports Affect Us

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

FDA has released the 483 Inspectional Observation reports involving the Blue Bell facilities following the recent Listeria outbreaks in ice cream. While most of the information contained in a 483 is not a big surprise to a typical food safety expert, I was still struck by some of the observations. Below are extracted sections within the 483 language that raised some questions in my mind.

Point 1

“Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination… Plant Environmental Program was used as an indicator determining whether the cleaning and sanitation program was effective. However this sampli ng program failed to include the following:

  • Sampling food contact surfaces.
  • Determination of the Listeria spp. associated with the presumptive positive results.
  • Root cause analysis of why the cleaning and sanitizing treatments were inadequate in controlling the occurrences of microbiological contamination.”

Q: Does this mean that FDA expects us to do zone 1 testing on a routine basis?
A: Based on this 483 – the answer is yes. But, if so, when should this be done? Is post clean up and pre-start up adequate? I sure hope so!

Q: Does this mean whenever we identify Listeria spp. we need to get it typed to determine the type of Listeria?
A: Based on this 483, the FDA will write you up if you simply stop at Listeria spp.

Q: Does this mean that every time we have a positive finding, we must document a root cause analysis?
A: Maybe…or is it only when we have multiple positives?

Point 2

“You also stated the results of your daily total coliform sampling on finished product, in process product, and raw ingredients added post pasteurization were used as an indicator in determining whether the cleaning and sanitation program was effective. However, this sampling program failed to include the following:

  • Determination of the pathogenicity of the coliform isolates.

Q: Does this mean when we find coliforms in finished product, or in ingredients being added post lethality or with in-process product, we need to determine if any of the coliforms would be considered to be pathogens?
A: The answer would appear to be yes.

Point 3

“Failure to store cleaned and sanitized portable equipment in a location and a manner which protects food-contact surfaces from contamination.”

This observation was related to equipment that was being stored in a basement area uncovered and unprotected, and that same equipment would be re-cleaned and sanitized prior to use.

Q: If you are storing equipment that has a food-contact surface, should the food-contact surface area be fully covered and protected, even if you will clean and sanitize it prior to production?
A: Based on this observation, the answer is yes. When you store equipment you will later use and if it has a food contact surface, make sure you cover and protect that surface during storage.

Point 4

“All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, you do not have cleaning and sanitizing procedures for employee shoes worn into the sanitary food production areas of the firm to ensure that any potential contamination risks are minimized.”

Q: Does this mean that, at all entries to a sanitary or RTE area, there needs to be a process for cleaning and sanitizing footwear?
A: While this is certainly a common industry practice, it appears to now be a requirement.

Point 5

“The design of equipment does not allow proper cleaning and maintenance. Specifically wooden pallets which are porous and not easily cleanable are used throughout your firm to store and transport raw ingredients, finished product, and packaging materials. The wood pallets were observed in different stages of damage and disrepair while they were being used in the kitchen, warehouse, freezer, production, and mixing areas. The top platform, bottom, and corners of the pallets were broken, discolored, and soiled. The wood pallets were also observed to be saturated from being used in the wet processing areas and were observed as having black mold-like residues and red stains.”

Q: Is FDA declaring war on wood pallets?
A: Certainly wood pallets are known to be a potential problem, but FDA is making it clear that you should not use wood pallets if they are damaged, discolored or soiled – even to store packaging materials or containers of food that will subsequently be used in production.

Conclusion

There are always opportunities to learn from others’ 483s, however, the above 483 extractions a little alarming. Not many companies will speciate Listeria spp., they will treat a Listeria finding as though it were LM and act accordingly. But based on these 483s, FDA could issue a 483 if you don’t speciate your Listeria spp. They could issue a 483 if you don’t test your coliforms in finished product or raw ingredients being used in finished product to see if any are pathogenic.

The language in the Blue Bell 483s is sending a strong prevention message to the food industry. It is also clearly using FSMA-like approaches. I see some of the observations in these 483s as being grenades that FDA has lobbed out – and it will be interesting to see if they have pulled out the pins as FSMA continues to roll out and FDA kicks up its inspections of food safety plans and preventive controls a notch. My message to the industry is this: Watch out and learn from others’ mistakes.

Randy Fields, Repositrak
FST Soapbox

The Silver Lining of FSMA Compliance: Leverage the Cloud to Mitigate Risk

By Randy Fields
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Randy Fields, Repositrak

It may seem counter-intuitive that any government regulation could generate an opportunity for food industry manufacturers, processors and marketers. But that is exactly the case with the Food Safety Modernization Act (FSMA). Manufacturers as well as your suppliers and customers need to invest in and change some business practices to comply with FSMA regulations, and doing so will enable them to bolster other processes and technologies to further cut costs and help mitigate risks not directly associated with food safety.

FSMA requires food manufacturers and your trading partners (both upstream and downstream) to have the documentation for regulatory compliance readily accessible for government inspection, with specific records required for companies that transport food or are deemed to be the procurer of foreign products. When you add these records to the business relationship records that food manufacturers, your suppliers and customers should already be maintaining (such as indemnifications and certificates of insurance that help manage brand risk), the databases start to become very large, very quickly.

The easy part of FSMA compliance for food manufacturers is with your largest customers and suppliers, because they likely have the processes and technologies in place to ensure both companies have the proper documentation. It’s really the group of smaller customers and ingredient providers, which can represent thousands of companies, that may not have the sophistication to supply the data points required under the law. Collecting and managing the information from these firms can be costly and labor intensive.

The good news is that cloud-based technology now exists to help all trading partners in the food supply chain meet FSMA requirements while working to prevent outbreaks and quickly limiting situations when they occur. This technology goes beyond just storing digital copies of documents—it helps to manage compliance with exception-based alerts for expired, missing or inaccurate records. It can also be the basis of an approval process for new vendors that incorporate record compliance. By linking and automating the management of compliance documentation and new vendor approvals, companies save time and allow for redeployment of resources to more productive activities. 

If you are serious about reducing brand risk, linking compliance management data with your purchase order system will swiftly and effectively accomplish that goal. Holding a purchase order for a non-compliant vendor protects the retailer, manufacturers and the consumer, and communicates a commitment to food safety within the entire supply chain. 

So, complying with government regulations such as FSMA doesn’t have to represent a significant one-time investment in technology and ongoing upkeep. Look to cloud-based technology with an eye for streamlining current processes, reducing overhead and supporting new customer or regulatory requirements.  And, being proactive to ensure the safety of your company and your customers will put you in a position to sell more and grow your market share. 

Melanie J Neumann is Vice President and Chief Financial Officer for The Acheson Group
Beltway Beat

From Beijing to Baltimore Integration and Collaboration a Common Theme

By Melanie Neumann, JD, MS
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Melanie J Neumann is Vice President and Chief Financial Officer for The Acheson Group

At the recent Food Safety Summit in Baltimore, the focus was on building an Integrated Food Safety System (IFSS) to aid in implementing FSMA and continued progress along the path of prevention vs. reaction, while at the International Forum on Food Safety (IFoFS) in Beijing, speakers emphasized colla boration for more effective and accurate communication of food safety risks.

In China, the media often over reports on food safety scandals that are actually food quality issues. Consumers are led to believe that food safety is a widespread problem across China and thus have developed a dis trust in the local food industry. At the heart of the matter is multi-stakeholder risk communication. The media is not solely to blame for this problem. Industry and regulators must be more proactive in communicating the true nature of food-related incidents in a way that is more accessible to consumers and the media.

The entrenched culture and government supremacy of China also contributes to the problem. The food industry typically does not communicate openly about food safety risks once the government has spoken out. However, at IFoFS, openness was a key focus, and I think we are at pivotal turning point. Chinese and other Asian companies, along with the Chinese FDA, have begun discussing the criticality and need for risk communication as it relates to food safety and food quality as a means to protect both consumers and food brands. One significant challenge involves instances in which errors in judgment are not quickly admitted when a regulator positions an incident as one of food safety when soon after it’s realized it is a quality issue. It’s safe to assume that regulators may not take the initiative to openly admit the misclassification, and speaking out against these issues may be perceived as openly challenging the government.

I also see the same phenomenon happening in the United States, but the over-reporting, is more so connected to the lawsuits against FDA and topical focus by consumer activist groups. For example, certain activist groups are over-amplifying the purported risks of GMOs, and we’re seeing over-reporting of the pressure and lawsuits against FDA related to FSMA deadlines. Similar to China, these issues are not food “safety” issues per se, but the media’s coverage exacerbates consumer misunderstanding and feeds a belief of widespread adverse food safety issues.

At the Food Safety Summit there was more focus on the integration and collaboration of federal, state, local, and regulatory bodies to implement FSMA. Michael Taylor, FDA’s Deputy Commissioner of Foods said that the publication of the final rules will meet the court-mandated deadlines, beginning in August. He added that there is an existing, established network between these groups, but FSMA elevates this association to a new level, because Congress has mandated it. The discussion of interaction and integration raised a question during a Town Hall on “integrating” the federal food agencies into a single agency. The general answer: If we were starting from scratch, we probably wouldn’t create separate agencies, but given that there are two today, there are more effective ways of integration versus completely disrupting the system to create a single-agency. (Sorry David—we know how much you would like a single food agency!)

The common thread? The U.S. and China are calling for increased relationship building and trust between all stakeholders. This common thread sews these two conferences, countries, and the global community together. But the question remains, with the media, consumers, regulators and industry seemingly still at odds with each other in both countries, how do we make this happen?

Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC
Bug Bytes

Five Pest Management Tips for Restaurant Employees

By Ron Harrison, Ph.D.
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Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC

Restaurants can face major risks related to pest activity, which is why a proper Integrated Pest Management (IPM) program must be in place. However, restaurant owners are not the only ones who should play a part in the IPM program; employees should participate as well.

Often times, live pests are sighted in restaurants, which can result in immediate consequences to a restaurant owner’s bottom line. Therefore, restaurant employees should be trained on how to prevent and react to pest sightings in their establishment.

The following tips will help restaurateurs get their employees on board with pest management:

  1. Contact a pest management professional for a complimentary on-site employee training that will teach employees the importance of pest management and how it could affect the diners’ experience.
  2. Diners have zero tolerance for pests. Ensure employees know the protocol for pest sightings, which should include:
    • Catching the pest for identification
    • Recording when, where and how many pests were seen
    • Assisting your pest management professional to determine the method of treatment.
  3. The most productive way to keep all employees involved in pest management is to add one or two pest control responsibilities to their daily routine. These responsibilities should align with employees’ roles and can be as simple as regularly emptying trash cans and re-lining them, or clearing and sweeping food debris.
  4. In common employee areas, post educational materials such as sanitation checklists and pest identification sheets that provide information on common pests and potential health threats.
  5. Establish an open line of communication that encourages all employees to report pests immediately. Remember that employees can bring pests into the restaurant on their belongings from home, so it’s important that they know pest sighting reports are encouraged to prevent pest activity in areas such as break rooms, the kitchen or the dining area. Fostering an open line of communication will help restaurateurs get ahead of any pest issues and related health and safety threats.
Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC
Bug Bytes

Make Employee Training a Team Effort in Your Pest Management Program

By Ron Harrison, Ph.D.
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Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC

Pest management plays a key role in food safety and product integrity, and ensuring such is a critical, facility-wide undertaking. The success of a pest management program can be the difference between acing a third-party audit and facing a plant shutdown. An effective program is not just a one-person job; it requires an ongoing team effort from a company’s pest management provider and all employees. As such, beyond selecting an effective pest management provider, it’s equally important to recruit employees to help enhance your efforts. After all, they are the eyes and ears of your facility, as they spend a lot more time there than your pest management provider.

Arming your employees with the right tools and pest control knowledge will set up your pest management program for success. The following steps outline how you can get your entire team involved in your company’s program.

Teach the what, where and how

Your employees can be the first responders to any pest problems, but only if they know what they should be looking for and where they should be looking. For that reason, it’s essential that they complete training on the specific pest pressures your property faces and the red flags that alert them to pest activity.

Many pest control providers offer complimentary employee training, so ask your pest management professional to conduct an on-site training session for your team. These training sessions should include not only information about the specific pest pressures on your property, but also the conducive conditions and pest hot spots that your employees can help control. Pest hot spots are the key areas inside and outside your building that pests target as entry or harborage points. These areas are in constant danger of being penetrated by pests and are areas that currently or have previously had pest issues. Areas with standing water, excessive condensation or improper drainage are just a few examples.

Your pest management professional can also teach your employees the key components of integrated pest management (IPM). Rather than reacting to pest issues, IPM takes a proactive approach through a combination of non-chemical solutions, relying on chemical treatments only as a last resort. Proper sanitation practices, ongoing property maintenance to exclude pests, and regular monitoring are paramount to a pest-free facility.

Training sessions are also a great way for your employees and provider to build a strong relationship so your team is more likely to proactively report any pest issues.

Keep the lines of communication open

An open, ongoing line of communication between management, employees and your pest management provider is also an important component of successful pest management programs. Regular communication helps ensure that your employees are kept in the loop on important pest control information and initiatives. Furthermore, an open line of communication will keep you thinking proactively about pest management, which can help reduce decisions that lead to reactive chemical treatments.

This open dialogue will also help build rapport with your employees so they are more comfortable talking about sensitive issues, including the potential for bringing pests into the facility from home. 

Know your role

Your pest management program will work best when everyone involved knows his or her role. Consider assigning each team member a specific pest management task based on his or her daily duties. For instance, employees involved in facility maintenance can monitor for small holes or gaps in the building façade and seal them immediately to help prevent pest entry. 

 

In case of a pest sighting

Sometimes no matter how effective your IPM program is, resilient pests can still find their way inside your facility. Further, pest activity may not only originate locally, but from other parts of the country throughout the supply chain, making it somewhat difficult to immediately pinpoint the pest issue. This means there is a chance for both live and dead pests to make their way into your product, which can pose a nationwide health and safety threats to consumers.

With this in mind, it’s important to have a plan in place should a pest be spotted. Establish a pest sighting protocol that identifies the steps to report a pest incident, including who should be notified. The following are a few examples of steps that should be included in a pest sighting protocol:

  • If possible, catch and show the pest to your pest management professional.
  • Record the pest activity in a pest sighting report, making note of when, where and how many pests were seen.
  • Work with your pest management professional to determine what is causing the issue and how to resolve it.

Continue the education

Your employees need continued education to help keep your property on the cutting edge of pest control. Many pest management providers offer educational resources that facilities can use as ongoing education, including tip sheets, sanitation and maintenance checklists, and seasonal pest management tips. Ask your pest management provider if they have resources you can share with your team. You may also consider having your pest management professional provide further training sessions on specific pest problems.

Pest control is most successful when a team effort is involved. Work with your pest management provider to get your employees up to speed on the pest management efforts at your facility and ensure they have the basic knowledge needed to play a role in keeping pests out.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Translating the Talk into Action

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

With a little less than two months under my belt as an editor in the food safety industry, I have already started to become a bad dinner date and my hands beg for mercy as a result of my newfound obsession with soap and water.

Quirks aside, I am seeing some common threads in this industry, although they are themes we see in any highly regulated industry. Partnerships. Collaboration. Transparency. Alignment. Accountability. Now more than ever, these words mean something. FSMA has forced the issue of food safety to the forefront. Yet, we’ve barely begun and I’m already hearing the phrase “FSMA Fatigue”.

For the folks who have been involved in preparing for FSMA from the start, they probably are a bit fatigued. There have been many meetings, and there’s been a lot of talking surrounding what’s going to happen, what needs to be done, and what challenges we’ll face (in many cases, together). But let’s not forget that not everyone is as well versed on the nuances of the regulation. I admit, I am raising my hand here… for now.

Now let’s back up a couple of sentences. “There’s been a lot of talk…” Yes, there has been. While these are enthusiastic discussions about what we as regulators, food processors, retailers, suppliers, scientists and everyone in between should be anticipating with FSMA rules and the consequent implementation, HOW are we going to navigate this new frontier?

Let’s start this conversation now.

You’ll see a lot of changes to Food Safety Tech this year. We’ve already started the information exchange with industry stakeholders about how we’re going to work together to get through FSMA implementation and the tools we need to arm our audience with to help them along this journey. We also just announced our Call for Abstracts for the Food Safety Consortium Conference in November.  The Consortium will bring together leaders and regulators in this industry and facilitate a forum for that candid “how” discussion. Food Safety Culture will receive strong attention, and key players will be presenting a case history of how to apply metrics to food safety culture within organizations.

I’m excited to join this industry, and thank you to those who have already extended a warm welcome. And for the many who I have yet to meet, please drop me a note as you encounter challenges or have ideas about critical food safety topics. Our job at Food Safety Tech is to provide a platform through which we can enable a constructive dialogue about overcoming challenges, working together effectively, and navigating this journey into the future of food safety.

Maria Fontanazza
Editor-in-Chief

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

World Health Day Shines Spotlight on Food Safety

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

Drawing attention to the fierce urgency to advance overall food safety and reduce the devastating impact of food borne illnesses around the world, the World Health Organization (WHO) dedicated the 2015 World Health Day to Food Safety. To support these efforts, the Laureate International Universities hosted a special webinar as part of its annual activities to mark World Health Day. During the webinar, Constance Shumba, a public health faculty at the University of Roehampton (London) and I explored the potential impact of FSMA on the global food supply with a case study on how the people and government of Uganda are advancing food safety in the sub-Saharan African country.

Globally, more than 2.2 million people, most of whom are children, die of foodborne and waterborne diarrheal diseases annually. In the United States alone, the CDC estimates that 48 million people become ill from food borne diseases each year. About 128,000 of these individuals are hospitalized, resulting in more than 3,000 deaths. The overall annual U.S. economic burden due to food borne illnesses is estimated to cost $77.7 billion.

These grim statistics illustrate the necessity to overhaul the outdated U.S. food safety system. FSMA is the most significant statutory change to both human and animal food safety in more than 70 years (since the passage of the Food Safety & Cosmetic Act of 1938). It is a radical shift from FDA’s previously reactive approach to a more robust, proactive scientific and risk-based prevention-oriented system. When fully implemented in 2016, the most important impact of FSMA will be to ensure that contaminated foods as well as those containing unwholesome or adulterated ingredients never reach retailers and consumers. Interestingly, FSMA may also positively affect the global food supply chain as it drives the improvement of food safety practices around the world, especially in countries that export food and food products to the United States.

Several provisions of FSMA will affect food exporters to the United States both in terms of reshaping their local food safety policies to align with the new law and the resulting improvement in food safety practices. Some of the areas of potential impact include:

  • Foreign Supplier Verification Program
  • Effective Traceability and Recall Program
  • Hazard Analysis and Risk-based Preventive Control (HARPC) System
  • Documentation and Record Keeping Inspections
  • Sanitary Transportation Rule for Human and Animal Foods
  • Produce Safety Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.

Notably, regulatory agencies of major U.S. trading partners are in the process of updating their food safety laws to ensure that local food productions remain in compliance with FSMA. Canada, Mexico, China and Australia are among the countries that are proactively working with their U.S. counterparts to ensure compliance and uninterrupted food exports to U.S. markets. Overall, it will be easier for developed economies with fairly robust food safety regulatory policies to upgrade and catch up with the new FSMA requirements.

Developing nations will be the hardest hit, as an extensive overhaul may be required to meet FSMA regulations. In the face of poor infrastructures, these countries may struggle when upgrading their systems to achieve compliance and maintain a certain level of trade relations with the United States, not just in raw materials or unprocessed food and food products, but also in valued-added food exports. Despite these challenges, these countries are motivated to remain trusted U.S. food-trading partners and will most likely improve their food safety policies and practices, thus helping to make the global food supply safer.

Uganda is an example of a developing country that is making serious efforts to improve its food safety policies and programs. The country is working on its Food and Drug Act of 1964 and its subsequent Drug Act of 1993 to develop a modern and unified National Food Safety Law. To make the global food supply safer through FSMA, the United States must collaborate with its trading partners around the world in building and upgrading their food safety systems. This would be beneficial to U.S. companies doing business in foreign countries either in terms of manufacturing their own private food labels or simply in assisting local industries in these countries in growing, processing and packaging food and food products destined for the U.S. market. It would also help these countries upgrade their food safety laws, improve export capabilities, and balance trade with the United States, consequently making food safer for their own citizens.

During the webinar we also emphasized the need to focus on the family kitchen in improving food safety practices around the world, using the five WHO key principles to a safer quality food:

  • Keep clean—engage in proper washing of hands and food contact surfaces
  • Cook food thoroughly to the required temperatures
  • Separate raw and ready-to-eat (RTE) foods to avoid cross-contamination
  • Keep food at safe temperatures to ensure that hot food remains hot and cold food remains cold at all times
  • Use safe water and raw materials to avoid cross-contamination

We all agreed that the culture of food safety must start in the home and at a very early stage in life and from there, spread to our schools, and public and private institutions. Food companies must do all that is necessary to uphold the integrity of the highly profitable food industry by delivering safe quality food to their customers. Overall, the global food supply chain will be made safer with a considerable reduction in food borne illnesses, and chemical or physical adulteration of foods.

The webinar referenced in this column, “From Farm to Fork – A Public Health Perspective”, can be found on the Walden University (Minneapolis) website.

Okenu is also affiliated with Walden University as a contributing professor in public health

Rick Biros, President/Publisher, Innovative Publishing Co. LLC
Biros' Blog

Food Safety Tech Welcomes New Editor

By Rick Biros
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Rick Biros, President/Publisher, Innovative Publishing Co. LLC

We launched Food Safety Tech three years ago this month.  Sangita Viswanathan has lead the editorial efforts for those three years and has played a significant role in launching Food Safety Tech and helping establish it as a leading industry news source.  I wish Sangita the best as she has left Food Safety Tech to spend more time with her family.

I am thrilled to introduce Maria Fontanazza as Food Safety Tech’s new Editor in Chief.  Maria has more than a decade of experience in journalism, marketing and communications within the medical device industry. While at UBM Canon for more than eight years, she served in various editorial roles, including as the managing editor for Medical Device + Diagnostic Industry (MD+DI). She has authored hundreds of articles that have appeared in domestic and international industry publications and has moderated educational sessions and panel discussions at various industry events. Maria also has experience in organizing industry conferences and tradeshows as well as in website design and development.

Maria brings contacts and experience to Innovative Publishing and will have an immediate impact on our medical device online journal, Medical Device Summit.  Having worked in an FDA regulated industry, the learning curve for the food industry will not be long, especially with the help of Food Safety Tech’s solid group of Editorial Advisors including David Acheson, Shawn Stevens, Mark Carter, Purnandu Vasavada, Hal King, Gina Kramer, Beth Johnson and Bill Bremer, to name just a few.  She will be traveling to many of the food conferences such as GMA’s Food Science Forum, Food Safety Summit, IAFP and the Food Safety Consortium.

This year, you will see many changes and additions to Food Safety Tech many of which will be spearheaded by Maria. She’s already had an impact with Food Safety Tech’s twitter account, @FoodSafetyTech, with frequent new tweets.

Please feel free to reach out to Maria with your thoughts, comments, perhaps your interest in contributing an article or just to say hi. 

All the best!

Rick Biros
Publisher/President

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

The Impact of FSMA on Private Label Food Retailers

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

When fully implemented, possibly by the spring of 2016, the new U.S. Food Safety Modernization Act (FSMA) will raise the bar on food safety regulatory compliance both in the United States and around the world. The key provisions of FSMA will shift emphasis from the current reactive approach to food safety and food security, towards a more proactive science-based risk mitigation and prevention strategy. The impact will be felt across the entire global food supply delivery system from farm to fork including private label foods manufacturers, processors, suppliers, importers and retailers.

It has been projected that the sales of private label groceries in the United States alone will grow by 36 percent from $98 billion in 2011 to $133 billion in 2016. This impressive growth may be as a result of the competitive pricing of private label foods and the comparable quality with major brand products, as well as the convenience and customer trust in these in-store retail brands by today’s savvy shoppers. The consumer-friendly collaboration of private label manufacturers and retailers, or retailers that own their own private label manufacturing facilities is known to reduce the unnecessary supply chain costs by improving supply chain efficiency, enhances processes and systems, and improves the overall customer experience. These great value-proposition attributes will continue to make in-store private label products popular among consumers and profitable for businesses.

An important question however is how the new FSMA regulatory climate will impact these private label food products amid this growing popularity and in the context of the core business benefits of active management control, competitive prices, considerable return-on-investment and consumer satisfaction. On top of this list is the FSMA requirement for risk-based foreign supplier verification. This is to ensure that imported foods manufactured by foreign third party vendors or by US companies running their own facilities overseas are in compliance with the new FDA requirements, and that the food products are not adulterated or misbranded. Retailers of private label foods will be required to provide documented evidence from an accredited certification entity that shows that their foreign-supplied food products are in compliance. Frequent inspections of these foreign-based facilities and foods imported into the United States will be mandated under the new rule.

FSMA also sets the bar higher for retailers of private label foods in the key areas of food safety record keeping and documentation, traceability/recall programs, upgrading from ordinary HACCP to the more advanced Hazard Analysis and Risk-based Preventive Controls (HARPC), and implementing a verifiable supply chain management program. These provisions have the potential of making it more profitable for companies to manufacture their private label foods here in the United States instead of overseas where they lack active managerial control to ensure full compliance. Although domestic US-based manufacturers and suppliers are already covered under FSMA, retailers of private label food products manufactured in the United States are still advised to consistently verify that their suppliers are compliant, since retailers will also be liable for any infringement or negative outcome from such products.

For private label retailers that have proactively pursued industry benchmarking standards by insisting on GFSI certified facilities and who have an effective verifiable food safety management system in place, the impact of FSMA will be minimal. They will only need to re-examine their processes and systems to identify any gaps within the provisions of the new rule and put corrective actions in place. For others hoping to play catch-up, implementing the new FSMA requirements may become so overwhelming that the obvious business benefits of in-store private label foods like competitive prices and comparable quality with major brands may become severely undermined. The relationship of private label food manufacturers and processors with their retail partners could be impacted, as retailers would need to collaborate to profitably deliver what their customers want, namely, safe quality competitively priced mix of private label and brand food products.

Although the production and sale of safe quality food is mandatory to all food companies, under FSMA, small companies with less than $500k in annual sales and who sell directly to consumers within 275 miles radius of their facility may be exempt from some of the rigorous requirements of the preventive control rule. However, when large companies patronize these small local businesses, they must ensure that they are in full compliance since liability extends to retailers. National food service chains that manufacture their own private label ingredients and condiments or obtain these supplies from third party vendors are also expected to comply with the new rules. Overall, companies will be better off taking proactive steps in evaluating their suppliers’ food safety management system in line with the preventative control provisions under FSMA.

In conclusion, FSMA brings with it, a complete paradigm shift that will impact the entire global food supply chain. Retailers of private label foods must continue to assure their customers that their favorite in-store brands were produced, processed, stored and handled in a safe manner every step of the way. Thus, FSMA readiness and preparedness must include a comprehensive gap analysis to identify provisions of the new rules that must be implemented to stay ahead of the curve by next year when these regulations will potentially come into effect.