Tag Archives: Food Safety Consortium

Stephen Ostroff, FDA

FDA’s Ostroff Says Foodborne Illness Still Resistant to Change

By Maria Fontanazza
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Stephen Ostroff, FDA

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

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

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

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

FSMA Update

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

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

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

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

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

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

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

Discussing Key Issues: Images from the 2017 Food Safety Consortium

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

Image credit: Michael Conaty

Deirdre Schlunegger, Stop Foodborne Illness
Food Safety Culture Club

Sharing Food Safety Stories Around The World

By Deirdre Schlunegger
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Deirdre Schlunegger, Stop Foodborne Illness

Last month, I spoke in Santiago, Chile at the Inofood Conference. I spoke about the impact of foodborne illness in the lives of individuals and families.

I showed photos of little Reese who died two years ago and talked about how Stop Foodborne Illness works with the food industry to drive home the importance of food safety and the consequences of foodborne illness. Together, we work to raise awareness, create and sustain strong food safety cultures and to promote the importance of food safety.

Deirdre Schlunegger will be speaking as part of a panel of experts during the Food Safety: Past, Present & Future Plenary Session during the Food Safety Consortium, November 29th at 4:00pm.

I was in good company with Frank Yiannas as he spoke of food safety culture and his book was even translated into Spanish for this conference. Tim Jackson from Driscoll’s and DeAnn Benesh from 3M addressed technical issues related to food safety and many others spoke. Food Safety representatives from Chile and around the globe were very interested and are dedicated to the topic and practice.

I am proud that we are among the nonprofit, behavioral and scientific experts and making a difference as food safety culture, tools, data and interventions improve. I have already been contacted to see if the video, which I showed in Spanish, can be used throughout Chile in the coming months.

Just a few days following his conference, I was in Greenbelt Maryland attending the JIFSAN (Joint Institute of Food Safety and Nutrition) Conference and Advisory meeting as I serve on the Advisory Council. The topic was Risk Analysis Tools and Data and it was a fascinating two days. Again, professionals who teach and share food safety knowledge around the world gathered to share vision, tools and practices.

The 5th Annual Food Safety Consortium conference will take place November 28 through December 1st and we will be there! We continue to see a strong drive and desire to improve food safety and we need to continue to press until the estimated number of people who die each year from foodborne illness diminishes significantly from 3,000 towards zero. No one should die from nourishing their body with food.

I am ending this blog with the powerful story of Aly: http://www.stopfoodborneillness.org/stories/aly/

Julie McGill

Make Your Food Chain Recall Ready At The 2017 Food Safety Consortium

By Julie McGill
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Julie McGill

As we reflect back on 2017, food recalls continued to dominate our headlines even after the implementation of FSMA. Our industry has taken corrective actions to limit risk. We want to protect consumers as well as our brands, limiting the financial and reputational damage that a recall can inflict on a company. We, along with consumers, are also more aware and in tune with the news due to social media and the 24-hour news cycle. It may appear that there are more recalls, but I would argue that the industry is more proactive and more accountable by submitting itself to voluntary recalls. Without a doubt, the food industry is under increased pressure.

Looking forward to 2018, we are reminded that it was 25 years since the E. coli outbreak at Jack in the Box. It was a monumental turning point in food safety that sparked the industry to modernize and examine processes. Since then, the food industry as a whole has come a long way. During my 16 years at GS1 US, working on programs such as the Foodservice GS1 US Standards Initiative, I saw food companies embrace global standards to increase efficiencies and build a foundation for traceability and supply chain visibility. Now adding Blockchain, Smart Labels, and IoT data to the technology mix will continue to advance the modernization of the food industry.

The good news for our industry is that consumers are patronizing companies that are embracing transparency as a strategic business strategy and these are the companies who are winning the market share as a result.

As stewards of our industry, we will always review our processes, continue to train and educate our employees and adopt better ways of guarding the supply chain. One way to become better at protecting the food chain and the public is exchanging ideas with our peers. We are stronger together.

That is why I am excited to bring together a diverse group of industry leaders for this year’s Food Safety Consortium to discuss this very topic. Titled, Is Your Food Chain Recall Ready?, I will be joined on Thursday, November 30th at 2:30pm CST by Jessica Jones, sr. specialist of Supplier Quality & Safety at Chick-Fil-A; Barbara Hullick, senior director of Food Safety at Produce Alliance and Bryan Cohn, vice president of Operations at Seal the Seasons.

During this panel session, we will discuss:

  • Best practices for FSMA compliance before, during and after a recall.
  • Best practices to execute precise, data-driven and timely recalls and stock withdrawals.
  • Establish and execute a process for escalation and post-recall audit reporting.
  • Work and communicate with suppliers and distributors on “what if” scenarios and what they can expect when quality issues arise.
  • Create a food safety culture which works in concert with legal, marketing and other internal teams.

I hope you will join us in person at the Renaissance Schaumburg Convention Center Hotel for the entire conference but if not, join us virtually! Registration details can be found on the Food Safety Consortium website.

Patricia Wester, PA Wester Consulting

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

By Food Safety Tech Staff
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Patricia Wester, PA Wester Consulting

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

Background on the AFSAP and FSC Alliance

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

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

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

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

FoodSafetyTech: How are audits used in FSMA?

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

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

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

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

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

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

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

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

§117.435 states:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Food Safety Tech

Enhancing Education, Chicago Section of IFT and Innovative Publishing Enter Event Agreement

By Food Safety Tech Staff
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Food Safety Tech

The Chicago Section of the Institute of Food Technologists (CSIFT) and Innovative Publishing, LLC, publisher of Food Safety Tech and organizer of the annual Food Safety Consortium, have entered into a Memorandum of Understanding (MOU) in support of each organization’s key industry events at the end of this year.

CSIFT will be holding its Annual Suppliers’ Night on Wednesday, November 1 at the Donald E. Stephens Center in Rosemont, IL. More than 500 organizations exhibit at the event, which is free to attend. “The Chicago Section IFT is the oldest and largest of the IFT sections. We are proud to host the largest regional suppliers night that draws over 3500 professionals to the Chicagoland area from around the country,” says Joy Dell’Aringa, business development manager at bioMérieux Food Pathogen and Quality Indicator Solutions. “This year, in addition to the Suppliers Night Expo, we are also hosting valuable scientific and professional development pre-show sessions.”

Food Safety Consortium, Stephen Ostroff
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.

CSIFT members will receive 10% off registration to the 2017 Food Safety Consortium, which will be held at the Renaissance Schaumburg Convention Center in Schaumburg, IL from November 29–December 1. The conference begins with a plenary presentation by Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by a town hall.

Pre-conference workshops begin on Tuesday, November 28 and run through the morning of Wednesday, November 29. Educational courses include the Certified in Comprehensive Food Safety Credential Exam Review Course, a FSVP workshop, a food defense workshop, a PCQI human food blended workshop (FSPCA curriculum) and SQF Information Day.

“The Food Safety Consortium was launched in the Chicago area for multiple reasons, and we consider Chicago our home,” says Rick Biros, conference director and president of Innovative Publishing. “The Chicago Section of the Institute of Food Technologists represents a large group of local food safety professionals and this partnership provides CSIFT members benefits to a focused food safety event. The ‘Consortium’ is a collaboration of multiple organizations, and we are honored to have the CSIFT as part of the team. This partnership commits the Food Safety Consortium to the Chicago area for the foreseeable future.”

“The CSIFT is pleased to partner with the Food Safety Consortium. This will bring value not just to our membership base, but to the food safety community as a whole,” says Dell’Aringa. “We hope this partnership leads to increased collaborations and engagement between our shared member base and the food science community.”

2018 Food Safety Consortium

Save the Dates for the 6th Annual Food Safety Consortium conference in Schaumburg, IL, a summit of Food Safety and Quality Assurance (FSQA) industry experts and government officials. The agenda is comprised of panel discussions, individual presentations, “Ask The Experts” discussion groups, workshops and training programs running concurrently, coupled with overarching plenary sessions paired with a table-top exhibition. This is an event focused on food safety education and networking providing attendees best practices and new technology solutions to today’s food safety challenges.

Food Safety Consortium 2017

Update: 2017 Food Safety Consortium Date Change

By Food Safety Tech Staff
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Food Safety Consortium 2017
FBI, food safety, terrorism
Watch Food Safety Tech’s exclusive video interview with FBI Special Agent Scott Mahloch at last year’s Food Safety Consortium

This year’s annual Food Safety Consortium will take place November 29 at 1 pm until December 1, concluding at noon. The main conference kicks off on Wednesday, November 29 at 1 pm with a plenary presentation by Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by a town hall meeting where he will answer audience questions. General sessions for the afternoon include a presentation on food defense given by Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI.

During the final session of the day, industry experts will gather for an engaging reflection on Food Safety: Past, Present and Future. Stay tuned for more details on this special event.

On Thursday, attendees will be treated to an interactive court case:

  • Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham, represented by Shawn Stevens vs. Food Safety victims, represented by Bill Marler. Stevens and Marler will be present their case to the honorable Judge Steve Sklare

In addition to the general event, there will be pre- and post-conference workshops. Pre-conference workshops take place on Tuesday, November 28, beginning at 9 am and run for the first half of the morning on Wednesday, November 29. Post-conference workshops take place during the afternoon of Friday, December 1, following the conclusion of the main event.

For more information, visit the Food Safety Consortium website: http://www.foodsafetyconsortium.org/ .

The super early bird discount ends September 8, 2017!

FSC 2016, Audits panel

Collaborating on Food Safety: Images from the 2016 Consortium

By Food Safety Tech Staff
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FSC 2016, Audits panel

Image credits: amyBcreative

Food safety superstar panel discuss controlling pathogens. Photo: amyBcreative

FSMA Implementation, GFSI Alignment and other Hot Topics to be Addressed at the 2016 Food Safety Consortium

By Food Safety Tech Staff
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Food safety superstar panel discuss controlling pathogens. Photo: amyBcreative
Food safety superstar panel discuss controlling pathogens. Photo: amyBcreative
Panel on controlling pathogens at last year’s Food Safety Consortium

Food Safety Leaders will meet to assess the status of FSMA implementation, the impact of GFSI alignment and important industry developments at the fourth annual Food Safety Consortium, December 5–9, 2016, in Schaumburg, IL. The Consortium brings together hundreds of Food Safety and Quality Assurance (FSQA) professionals, and scores of speakers over several days attending concurrent conference tracks, workshops, training programs, plenary sessions and exhibits.

“Engagement at this year’s Food Safety Consortium will be more powerful and valuable to the industry, as we have the convergence of key federal officials and top industry experts sharing expertise and guidance on the future of the global food safety industry,” says Rick Biros, president and publisher of Innovative Publishing. “With FSMA compliance dates now in motion, attendees will hear directly from FDA and other regulatory agencies on how implementation is going, the status of enforcement actions, how GFSI fits in and more.”

The Consortium conference begins on Wednesday, December 7, kicking off with a keynote presentation from Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, followed by an “Ask the FDA” Q&A Town Hall. Frank Yiannas, vice president of food safety at Walmart, will deliver the lunch keynote presentation on December 7.

Audience response during Food Safety Culture debate. Photo: amyBcreativeConference tracks will address FSMA and GFSI compliance, food manufacturing and operations, supply chain management, laboratories, and ask the experts discussion groups.

Pre-conference (December 5) and post-conference (December 9) workshop topics include Preventive Controls in Human Foods training, supplier verification, HACCP to HARPC, SQF Information Day and recall strategies.

To register for the Food Safety Consortium, visit http://foodsafetyconsortium.org/. For more information about Food Safety Tech, the event media sponsor, visit https://foodsafetytech.com/food-safety-consortium/.

Food Safety Consortium Team
The Innovative Publishing staff

About Innovative Publishing: Innovative Publishing Company LLC (IPC) delivers industry-specific opportunities for business growth and professional development through an integrated B2B platform that includes online publishing, conferences, webinars and hybrid events. IPC launched MedTech Intelligence @MTI_Editor (https://www.medtechintelligence.com/) in 2010; Food Safety Tech @FoodSafetyTech (http://www.FoodSafetyTech.com) in 2012; and Cannabis Industry Journal @CannabisEditor (https://www.cannabisindustryjournal.com/ ) in 2016. Our focus is to provide game-changing knowledge and expert opinions about breaking news, innovative technology, emerging trends and ever-changing international regulations. Our mission is to aid in the advancement and progress of global industries that contribute to a healthier world.