Tag Archives: FSMA

FSC 2016

FSMA, Listeria, Fraud and Food Safety Culture Among Top Topics at Food Safety Consortium

By Maria Fontanazza
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FSC 2016

The 2016 Food Safety Consortium was a big success, from the preconference events that included the STOP Foodborne Illness fundraiser honoring heroes in food safety and the education workshops (SQF Information Day and preventive controls courses) to the record-breaking attendance we saw during the main program (with keynotes from FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., Walmart’s Vice President of Food Safety Frank Yiannas, and FBI’s Special Agent Scott Mahloch).

As the event winded down, the leaders of each session track shared their insights on lessons learned during the Consortium.

Understanding biofilm and how it forms.  If you’re seeing peaks and valleys in the positives and negatives in your environmental swabbing program, you may have resident Listeria that has formed a biofilm, which requires a deep clean. Focus on biofilm, not just mitigation of the Listeria bacteria itself. – Gina Kramer, Savour Food Safety International. Read Gina’s column, Food Safety Think Tank, where she talks about the latest technology and innovations.

This is the first conference I’ve been to you where food fraud is being more widely acknowledged as a serious, important concern that is distinctly separate from food safety. One of the more significant takeaways is the number of tools that are now available for people to mitigate their risk to food fraud in the supply chain. – Steve Sklare, USP

Warren Hojnacki, SGS
Warren Hojnacki, SGS

A while back food safety was a nice-to-have but not a need-to-have. It’s certainly an absolute need-to-have now. There are three groups of individuals out there: The third that has picked up the baton and is proactive, the other third that are in the middle of it right now, and the other third have their heads in the sand. I come across a sizable portion that is in the bottom third, and it’s slightly scary… It’s the documentation that a lot of companies are having the biggest challenge in dealing with—the death by paper. The resources out there are immense. It’s a necessity to have right now in order to be effective and compliant.  – Warren Hojnacki, SGS

FSMA regulations require us to be risk based, scientifically based and systematic in our approach to our concerns and issues. – Barb Hunt, Savour Food Safety International

There’s potential for greater data and actions: i.e., the microbiome study or particulate contamination analysis, PLM, IR spectroscopy, SEM EDS, [and] raman spectroscopy…Lab customers may need to depend more greatly on contract labs as FSMA develops and in return, labs need to work more closely with the customers to get dependable, defensive data results. – Eric Putnam, Wixon, Inc.

Trish Wester, PA Wester Consulting
Trish Wester, PA Wester Consulting

We need to do a better job of messaging upstream to our corporate senior officials so we get the money and resources we need—there’s still a gap there. We need to find ways to communicate to them.  – Trish Wester, PA Wester Consulting

Stephen Ostroff, FDA, Food Safety Consortium

How Will FDA Gauge FSMA Success?

By Food Safety Tech Staff
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Stephen Ostroff, FDA, Food Safety Consortium

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreHow will the FDA gauge how well the food industry understands FSMA? This question was posed to agency Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D. at the 2016 Food Safety Consortium.

While it will be important for FDA to have measures that it can use in assessing compliance, the process will take time. Watch Ostroff’s response in the following video.

Read the article: FDA on Enforcement: Our Goal Is to Help, Not Punish

2017 Food Industry: 4 Trends to Watch

By Katy Jones
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From countless recalls, to FSMA deadlines, to the rising demand for transparency, 2016 has been a monumental year in the food industry. With 2017 knocking, here are the top trends and predictions to watch out for in the food industry next year.

1. Moving Toward a Fully Digital, Connected Supply Chain

The food supply chain in many ways is still lagging behind in technology compared to other supply chains. In 2017, many companies will begin or continue on their journey to fully digitize their supply chain, whether that is simply getting their list of approved suppliers out of an Excel spreadsheet and  into a supplier management software technology solution or fully capturing every step of their products along the journey from farm to fork.

The spectrum of digitization across the supply chain is quite broad. But bottom line, supply chain analytics will empower food companies to create useful KPIs, allow them to truly measure the ROI of their supply chain initiatives and give consumers the transparency that they demand. And systems that fully support the daily monitoring, sharing and interpretation of those analytics needed to help companies will experience tremendous growth in 2017.

Collaboration with your supply chain partners is an absolutely critical element, and we can expect to see more companies fully integrate throughout their network of suppliers and customers. Food companies that will succeed in 2017 will need a fully integrated supply chain network, with access to the same information, working towards a shared mission to deliver results and be ahead of their competitors. A connected supplier network will allow food companies to be agile when faced with an issue, responsive to recalls, as well as be flexible and efficient.

2. Recalls, Recalls, Recalls

We saw a high volume of recalls this year, and this trend is not going away anytime soon. As more and more advances in food testing are made, companies will have access to new technologies across their supply chain that will identify issues early. Consequently, more products will need to be pulled out of the supply chain because of that increased testing in order to maintain consumer sentiment.

The companies that are able to roll out these capabilities quickly and efficiently—armed with the data needed—will be well poised to manage their supply chain, potential recalls and the impact to their customers. With the knowledge that we can expect to see several recalls in the new year, food companies should be looking to mitigate risks and better manage their supply chain.

3. Full-force FSMA Is Here Whether You Like It or Not

FSMA focuses on amplifying preventive controls for food production in order to alleviate potential food contamination outbreaks, and the past two or more years have been focused on this preparation. This preparation will come to a pinnacle in 2017, the first full year of FSMA implementation worldwide, with the FDA starting audits for larger companies. This could lead to the FDA requesting required records, conducting audits and in the worst situation for food companies, shutting down operations if they feel it’s necessary.

FSMA will require detailed record keeping when a recall or outbreak occurs, with clearly defined corrective actions in place. Companies will see an increased need for technologies that help supply preventive processes such as food allergen and sanitation controls, as well a prepared recall and supply chain plan. Tracking and traceability will be the two key parameters that will offer manufacturers the ability to examine specific foods and trends to improve their overall process. In order to comply with these new FSMA regulations at every step of the process, food companies will increasingly look to utilize these technologies to account for full traceability of the supply chain.

4. Growth in Foodservice At the Consumer’s Doorstep

Brands like Starbucks and Panera have been testing the food home delivery waters, but more companies seem to be jumping onto the trend of bringing gourmet food directly to the consumer’s doorstep—Blue Apron, Plated, HelloFresh just to name a few.

FSMA

FDA Updates on FSMA Training

By Food Safety Tech Staff
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FSMA

Today FDA updated its FSMA training strategy to reflect the progress made during 2016. The program, which targets farmers, small food processors and small produce merchant wholesalers, includes the following updates:

  • Cooperative agreement for small and mid-size businesses involved in local food production awarded to the National Farmers Union Foundation
  • Cooperative agreement for preparing food producers in Native American tribes awarded to the University of Arkansas in Fayetteville
  • Federal grants awarded for establishing regional centers to facilitate training under FDA’s partnership with USA’s National Institute of Food and Agriculture
FSC 2016, Ostroff and Almanza

Are Final FSMA Rules Cast in Stone?

By Food Safety Tech Staff
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FSC 2016, Ostroff and Almanza

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreEarlier this month Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, told attendees at the 2016 Food Safety Consortium about the agency’s commitment to a proactive food safety system. He also discussed FDA’s stance on criminal liability and took questions from the audience, one of which was:  Now that the FSMA rules are final, are they cast in stone? Does FDA have any flexibility in making changes. Listen to Ostroff’s answer in the following video.

 

FDA

FDA Issues Final Rule on FSMA Third-Party Certification User Fee Program

By Food Safety Tech Staff
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FDA

This week FDA issued a final rule that provides for a user fee program to evaluate fees and require reimbursement for work that FDA performs to establish and administer the third-party certification program. The rule, “Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program”, is effective January 13, 2017.

FDA also announced its fiscal year 2017 fee rate for accreditation bodies that are applying to be recognized by the third-party certification program. The fee will remain in effect through September 30, 2017.

FDA on Enforcement: Our Goal is To Help, Not Punish

By Maria Fontanazza
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Over the past year and a half, much attention has been given the federal government’s commitment to prioritizing prosecution of food companies that engage in criminal behavior. In some instances, this has been used as a scare tactic, shining a spotlight on the executive responsibility of company executives.  Although focusing on executive liability isn’t necessarily a bad thing, Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, wants food manufacturers to know that FDA isn’t out to get them.

During yesterday’s opening keynote presentation at the 2016 Food Safety Consortium, Ostroff commented on FDA’s approach to enforcement. “I often have to scratch my head as why this has been such a tremendous concern in a regulated industry…sitting at FDA, we have not had any change in our thinking and approach about liability,” said Ostroff. “FDA pursues legal action against companies that are clearly negligent and clearly violating the law.” He emphasized that FDA’s goal moving into the FSMA compliance phase hasn’t changed; it’s about implementing a food safety system focused on preventive controls.

Ostroff encouraged attendees to look at the areas in which their food safety system is vulnerable, take proactive action and build redundancies into their system. “The best defense is to comply with the new requirements, and document how you are creating a food safety culture where everyone understands the expectations,” he added. “If you’re making a good faith attempt—our goal is to help you accomplish that goal, not to punish you for the attempts that you’ve made in good faith.”

The deputy commissioner also commented on the agency’s progress since FSMA’s seven rules were finalized in May, pointing out that these rules are foundational, and additional rules are to come. These rules will address lab accreditation, traceability related to imported products and a reportable food registry tool.

“If when we visit we identify very significant food safety hazards that we think pose an imminent risk of foodborne illness, we will have to take action.” – Stephen Ostroff, M.D.

Other key areas Ostroff discussed regarding agency progress and initiatives included:

  • Initial compliance date for FSMA Preventive Controls Rule (for large companies). FDA wants to be a partner in assisting companies with the preventive controls requirements. “That for us will require a lot of work on the part of those who are going to be conducting these inspections, but our goal is to help you and tell you in which areas you’re doing quite well and in which areas you can do better,” said Ostroff, adding that many of the aspects of the preventive controls rule are very similar to what many companies have already done.
  • Foodborne outbreaks. With several outbreaks in the 2015–2016 timeframe (ice cream–Listeriosis; cilantro–cyclospora; cucumbers­–Salmonellosis; Mexican-style fast food–E.coli O26; flour–E.coli O121), the Inspector General expressed concern over the FDA recall process and criticized the agency for not having  better defined timeframes. In response to that report, FDA implemented the SCORE (Strategic Coordinated Outbreak Response and Evaluation) team, which guides concrete action plans for measures that the agency must take in the areas of recalls, for example. The team consists of decision makers from key operations and enforcement offices with a goal of expediting the evaluation of compliance and enforcement options. Since April, SCORE has addressed flour contaminated with peanut protein, facilities contaminated with Listeria, Salmonella in pistachios, and baby food that was not manufactured in compliance with infant formula regulations.
  • Antimicrobial resistance. The issue is “getting attention at the highest levels of government,” said Ostroff, adding that the best way to address antimicrobial resistance is to not have to treat it in the first place—and to do this is through reducing the incidence foodborne illness. The agency is moving forward in several areas here, including addressing non-judicial use of food animals and veterinary settings; enhancing NARMS data and isolate collection; and collecting data on antimicrobial sales by species.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.

During the Town Hall part of the presentation, Ostroff was asked, with the finalization of the FSMA rules, are they cast in stone? His answer: Not necessarily. “It took five years to get in place…because we did it in a very systematic way with a lot of stakeholder input. When you put together rules that are this complicated, there’s no guarantee that you got everything right,” he said. “[We] have to recognize that sometimes some of the flaws don’t become apparent into you implement them. You always have to be of the mindset that if everything didn’t work out exactly the way things were anticipated…we always have to be open to the fact that as we move forward and implement the rules, we might have to make course corrections.”

Katy Jones, Foodlogiq
FST Soapbox

Mitigating Supply Chain Risk with Transparency and Traceability

By Katy Jones
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Katy Jones, Foodlogiq

Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREA recent study from The Hartman Group on the topic of transparency found that consumers are becoming more concerned about imports and the safety standards behind companies producing food and beverage products beyond U.S. borders.

So with the drastic rise in consumer expectations for food quality and safety in the past few years, how can companies ensure they’re mitigating risks in the supply chain while fostering transparency to meet consumer expectations?

To our benefit, the focus of the broader food industry and the government, as well as innovations in technology, are making it easier than ever to comprehensively track the supply chain.

Another Day, Another Food Recall, Another Listeria Scare

In today’s reality, whether we like it or not, food recalls are an inevitable part of the food industry, and adulteration in the supply chain is a key safety issue. With the wellbeing of consumers at stake, if a contamination finds its way into a brand’s supply chain, the best possible course of action is to take action on a recall using impeccable supply chain records and monitor the affected product moving throughout the chain.

With recalls being here to stay in the food industry, companies need to be prepared to handle these issues quickly and effectively. By implementing supplier management and whole-chain traceability software, allergens and impurities can be pinpointed to a specific lot of product as opposed to being limited to processing/issue date, and not knowing the source or country of origin of every ingredient (as many suppliers can contribute to one product) within the supply chain.

Additionally, with these technologies, brands can keep their supply chain transparent and compliant with growing industry regulations. With consumer standards on the line, proactive transparency can ensure that a company has a plan of attack when the inevitable hits.

A Targeted and Precise Plan

Companies and brands need to broaden their definition of food safety in order to manage and satisfy an expanded set of consumer expectations. The traditional, linear “one-up and one-back” (OUOB) approach to supply chain is no longer acceptable when it comes to comprehensive supply chain transparency.

Consumers need a targeted and precise plan when dealing with the safety of their food—it’s no longer just about whether the food safe to eat. The definition has expanded to include safety around ingredients and country of origin. Awareness of where a product came from and where it is going next is not an acceptable method if a company wishes to foster transparency with customers and effectively manage recalls. In addition, these standards are emphasized by federal regulations like the FSMA and FSVP—the industry is now shifting towards preventative approaches to safety matters, as opposed to reactive. FSMA requires food manufacturers to increase focus on prevention rather than response to contamination incidents, which will require a comprehensive view of the entire supply chain.

Brands will need to develop strong food safety plans with streamlined audits and compliance records, verifying supply chain partners and executing corrective actions for suppliers that are not in compliance with the process and food safety plan set in place. In establishing this process, having the technology to support it is paramount in ensuring that suppliers are sticking to the food safety practices necessary to follow industry regulation and exceed consumer expectation.

Transparency in Today’s Complex Food Paradigm

As the global food supply continues to grow in volume and complexity, brands have an opportunity and an obligation to adapt to the food paradigm. According to a Label Insight study, 94% of consumers say transparency from food brands is the #1 factor that impacts purchase. Brands are no longer able to blame a supplier’s lack of transparency or unreliable records for exposing consumers to unsafe products but instead, the brand is solely held accountable.

Transparency and proactivity were optional in the past, but are now established as fundamental components of a brand’s safety plan if they are to adapt to the changing industry landscape as well as consumer demand. As recalls are bound to happen, proactivity and transparency can ensure that a company is one step ahead of an outbreak at all times.

The fact is, adapting to this shifting environment and aligning with these best practices and the technologies that enable them is critical to the success of the supplier, distributor and across the whole supply chain. Food companies must look to utilize big data analytics and intelligent supply chain mapping technologies in order to improve transparency and increase traceability. With the ability to track ingredients back and forth across the supply chain, these technologies enable a safer consumer experience as well as provide tremendous business value in eliminating inefficiencies, managing supply chain issues, and effectively protecting the brand with the insights offered.

Randy Fields, Repositrak
Retail Food Safety Forum

The Fresh Food Supply Chain and Product Safety

By Randy Fields
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Randy Fields, Repositrak

Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREFresh foods are critically important to grocery retailers because these categories help create a point of differentiation from competitors. Store operators highlight the fresh sections in ads, promote the categories with in-store signage and now support the departments digitally and through social media. This isn’t to say the center store dry grocery items aren’t marketed, but they don’t get the advertising and promotional love that the produce, meat, dairy, deli, bakery and floral areas receive.

Given this focus, retailers and their suppliers work diligently to ensure the safety of the fresh products offered. They know that one slipup in produce or the deli can wreck the company’s reputation for months or longer. This is particularly true for the many fresh products that don’t have a brand standing behind them to share the impact (or blame).

Ask retail food safety directors where they spend most of their time and the answer 90+ times out of 100 is in the fresh areas. There are simply more things that can potentially go wrong in fresh and less that can go wrong with dry grocery. Sure there is the occasional ingredient issue, but the center store doesn’t have to worry about spoilage or even packaging problems now that nearly everything is tamper proof.

The bioterrorism act mandates that each link in the supply chain knows where their ingredients or product came from and where it was distributed. Recently, much effort has gone into developing traceability technologies and processes with the produce supply chain taking the lead. Growers and their trading partners are piecing together systems that allow practitioners to follow each batch of product through to the retail store, but the operative phrase is “piecing together.” Very few technologies can provide complete farm-to-fork traceability without standard product identification codes used by all participants in the supply chain. When a participant does not use the standard product identifier, visibility to the path of a product ends.

On the regulation front, the seven FSMA rules move the emphasis of the FDA from detection and response to prevention, which impacts both fresh and shelf-stable products. On a practical level, however, compliance with the rules is often more challenging for fresh products because of their limited shelf life. Also, some of the rules apply specifically to produce, meaning retailers and their produce suppliers need to pay special attention to preventing foodborne illness in the department.

At the recent Produce Marketing Association’s Fresh Summit in Orlando, Bob Whitaker, Ph.D., the trade group’s chief science & technology officer, and Jim Gorny, Ph.D., vice president, Food Safety & Technology, both emphasized the importance of communicating each retailer’s and supplier’s compliance with the FSMA regulations to the consumer. The North American Meat Institute, International Dairy-Deli-Bakery Association and other trade groups representing the marketers of fresh products have also been very active in helping both retailers and suppliers comply with the new regulations.

Beyond FSMA, retailers and their fresh foods suppliers need to do more work to not only ensure a safer supply chain, but to let consumers know they are working on food safety every day. Transparency needs to extend throughout the supply chain so suppliers and carriers can report on any potential safety issue from the farm to the checkout stand, because retailers are requiring more support from suppliers and more documentation for each load received. And, audits need to be periodically conducted to ensure accepted industry best practices are being followed.

Technology is helping the food safety process, especially in the fresh area, by organizing documentation for FSMA compliance and by providing supply chain transparency. The systems now available integrate all product and vendor information into a retailer’s ordering systems to ensure every requirement is met before a purchase is completed. They also send out alerts when additional details are required and they confirm that each lot shipped adheres to accepted best practices for food safety.

At the end of the day, all items sold in a supermarket or online must be safe for the consumer. The challenge is somewhat bigger with fresh foods than it is with dry grocery, so retailers and their suppliers must work that much harder to ensure the safety of products sold to their customers. A combination of accurate document management, compliance audits and traceability technology is now the most likely scenario to accomplish this goal.

FDA

FDA’s Offers Answers on Food Facility Registration

By Food Safety Tech Staff
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FDA

FDA has released a draft guidance to help food facilities that manufacture, process, pack or hold food for consumption in the United States. Aptly titled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Draft Guidance for Industry”, the document is a 15-section Q&A addresses Food Facility Registration, of which the renewal period began on October 1 and ends December 31. The seventh edition of the guidance also adds information related to the Amendments to Registration of Food Facilities final FSMA rule.

The agency is accepting comments on the draft guidance until February 6, 2017.