In today’s risk-based world, companies can’t just trust a third-party auditor based on a handshake, according to Melanie Neumann of Neumann Risk Services and Matrix Sciences. It is also a manufacturer’s responsibility to verify the auditor. Watch the following video, shot at this year’s Food Safety Consortium, to hear Neumann’s take on “trust but verify” and the importance of inspection and audit readiness both today and in the future.
The CDC estimates that Salmonella, E. coli O157, Listeria monocytogenes and Campylobacter cause 1.9 million cases of foodborne illness in the United States. A report just released from the Interagency Food Safety Analytics Collaboration (IFSAC) analyzed data from more than 1000 foodborne disease outbreaks involving these pathogens from1998 through 2013.
The report found the following:
A copy of the report, “Foodborne illness source attribution estimates for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States”, is available on the CDC’s website.
David Theno was scheduled to speak at this year’s Food Safety Consortium during a special session recognizing the 1993 Jack in the Box E.coli outbreak as a breakthrough moment in food safety. His untimely passing changed the course of discussion at the event to a reflection on Theno’s legacy and the significant changes that the industry has gone through over the past 25 years.
In the following video, Steven Sklare, director of customer engagement, foods program at USP, shares his thoughts on the importance of having an appreciation for what the industry went through in 1993 and the significant impact it had on the how the industry has changed since then.
What events in food safety do you think have had the most impact over the last 25 years? Share in the comments below the video.
Paradigm Diagnostics develops and markets novel diagnostic screening tests for bacterial pathogens causing foodborne illness. The company currently markets two environmental screening tests for detection of Listeria and Salmonella in the food-processing environment. The new method for analysis of ground beef offers analysts greater ease of use, lower cost, and fewer steps to simultaneously detect and isolate bacterial pathogens, E.coli and Salmonella, than the current USDA method.
The new method is significant since the USDA mandates that all ground beef and beef trim produced in the United States be continuously screened for the presence of pathogenic E.coli and Salmonella in an effort to enhance the food safety of meat produced domestically. This method is compatible with modern genetic methods used in large laboratories. Significantly, the method allows smaller laboratories to conduct these analyses since the method conforms to traditional cultural methods used in microbiology. The company is investigating the applicability of the new analytical method to monitoring the food safety of produce, fruit and grains.
Today FDA released a draft guidance to provide information about what actions by a foreign food establishment or government are considered a refusal of inspection. “FSMA gives the U.S. Food and Drug Administration the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment that produced the food,” FDA stated in a release.
The 12-page draft guidance, Refusal of Inspection by a Foreign Food Establishment or Foreign Government, outlines how the agency goes about scheduling inspections of foreign establishments (despite the fact that FDA is not required to pre-announce inspections), the inspection activities themselves, and very detailed examples of what it considers an inspection refusal from a facility (from a lack of communication with FDA that delays the agency’s request to schedule an inspection, to preventing an FDA investigator from entering a facility, when a facility sends staff home and tells FDA that it is not producing product).
The draft also details what it considers to be refusal of inspection by a foreign government. Some of the actions include preventing FDA investigators from entering the country or asks them to leave the country before an inspection is scheduled; and limiting access to areas of the facility that manufacturing, processing and packaging occurs; and limiting investigators from collecting samples for analysis.
If either a foreign food establishment or a foreign government refuses an inspection, they will stay on the agency’s Red List of Import Alert 99-32 until FDA is able to schedule and conduct an inspection.
Matrix Sciences recently announced the acquisition of Neumann Risk Services, LLC (NRS), led by Melanie Neumann, J.D., M.S., according to a press release. Neumann’s venture, NRS, combines a consulting business with a legal practice, focusing in the areas of food safety, food science, food defense, recall & crisis management.
Adding NRS to the Matrix Sciences portfolio allows them to further grow their consulting capabilities, working with Neumann to expand their set of services. She will be building a suite of services targeted at helping companies reap the benefits of their investments in food safety risk management, according to the press release.
In addition to taking the role of Executive Vice President and General Counsel for Matrix, Melanie Neumann will also maintain Neumann Legal Services, a separate but allied legal practice. “I made the decision to join Matrix Sciences because our vision for meeting the changing and unmet needs of the food industry align very well,” says Neumann. “But more than that, our value in how we need to meet those needs make for a great fit.”
Neumann received her law degree from Mitchell Hamline Law School and a Master of Science in Food Science from Michigan State University. Neumann has worked as an attorney in a number of capacities at major food companies throughout the world, building herself a reputation as a prominent consultant, thought leader and adviser in the world of food safety.
Robert Wiebe, chief executive officer of Matrix Sciences, says this acquisition is an important step in their growth strategy. “Melanie and NRS are critical to building a true full-service solution provider,” says Wiebe. “Building on the capabilities and capacity from our acquisitions of Richter International and Northland Laboratories, our portfolio of companies represents a growing and unique partner for our customers in addressing the challenges and opportunities in bringing safe food to market.”
“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?
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.
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:
Image credit: Michael Conaty
Last week, 3M Food Safety announced their 3M™ Molecular Detection Assay 2 – Cronobacter was designated by AOAC International as Performance Tested Method (Certificate #101703). The assay is compatible with their Molecular Detection System, which uses isothermal DNA amplification and bioluminescence detection to test for pathogens.
Cronobacter, a type of bacteria commonly found in powdered foods, supplements and baby formula, can survive for almost two years and exposure to an infant can be life-threatening.
“While less well known than other foodborne pathogens like Listeria or Salmonella, Cronobacter is no less dangerous – particularly because it preys on some of the most vulnerable populations,” says 3M Global Marketing Manager Carolina Riba. “It’s a point of pride for our team that the tests we’ve made for the dangerous pathogen were recognized by an organization like AOAC International.”
Using approved protocols set by the AOAC Research Institute, 3M’s testing process used an independent laboratory. They tested the assay on powdered infant formula, powdered infant cereal, lactose powder and an environmental surface.
The food industry has been one of the most celebrated and fastest-growing industries over the last decade or so. Which is no surprise, considering how much food is now being consumed, or posted on Instagram, on a daily basis. Pop-up food carts and hole-in-the-wall food places have been a huge hit too and even inspired a number of Hollywood films about the tough competition and revolutionary marketing tactics that have taken over the food industry (see: Jon Favreau’s Chef and Bradley Cooper’s Burnt). It’s good times, for sure. Well, for the most part, I mean.
Unfortunately, it’s not just the revenue that’s on the rise, because food borne illnesses too are making the headlines as of late. Talk about spoiling (no pun intended) the fun, eh? Well, according to the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, the number of foodborne disease outbreaks resulting from imported foods increased during surveillance years 2005 to 2010.
Dr. L. Hannah Gould, Ph.D., a senior epidemiologist at the CDC, revealed those findings during an oral presentation here at the International Conference on Emerging Infectious Diseases in 2012. According to the CDC, 39 foodborne disease outbreaks were reported in which the implicated food had been imported into the United States. These outbreaks resulted in 2348 illnesses, 434 hospitalizations and 3 deaths.
Though foodborne illnesses are often never formally reported, about 48 million Americans, or one in six, get sick each year from food, the CDC estimates, with 128,000 hospitalizations and 3,000 deaths. In fact, in 2014, 19,542 cases of infection were traced from 15% of the US population being surveyed by CDC.
The culprits? Chances are, you’ve been storing them somewhere inside your establishment: packaged caramel-coated apples, frozen ice cream sandwiches, fresh peaches and nectarines, frozen meet, etc. Not exactly the answers you were expecting, perhaps?
According to experts, the growing popularity of packaged foods such as pre-cut fruit and prepared sandwiches has heightened the risk of spreading foodborne illnesses. Furthermore, they have identified that contamination can occur between preparation and packaging, or in high-tech processing plants, after heating to destroy harmful bacteria and before packaging. Which means, somewhere in the last decade, we lost our way (or something like that).
The whole fiasco regarding foodborne illness is a public safety concern and must be addressed by everyone. However, while adjusting individually may not be a problem for most of us, the same cannot be said for food places and restaurants. Just imagine the public relations horror for restaurant managers if any of their customers get sick while dining at their place?
Restaurants must be more strict and thorough when addressing food safety concerns. The entire crew must be trained when it comes to food handling and a food safety manager must also take charge in overseeing procedures in the kitchen. In fact, proper storage and disposal must also be adequately done at all times. With those safety measures in play, establishments will be able to showcase their commitment to adhere with local food standards and basic food handling procedures. That’s a step in the right direction, for sure.
Summing up, foodborne illness is definitely a manageable concern and will likely not become a factor that will hinder the overall growth of the food industry. However, the fact that it can be controlled and yet still recurring means that there’s still a fair amount of work needed to be done to improve the industry in other aspects—and that isn’t necessarily a bad thing (at least not yet).
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