Inside Out Quality
Inside Out Quality
When Milk Goes Bad: With Kate Haiar
In 1909 food buying food came with a risk. Sadly, in a Rhode Island orphanage, 22 infants died from contaminated condensed milk. Today that's unheard of. Why? GMP manufacturing, FSMA, and other quality and regulatory controls.
Kate Haiar, Quality Director for Regulatory and Audits and Sunbutter Divisions at Red River Commodities joins me to discuss all things food quality. Join us on this episode as we break away from our usual discussions on drugs and devices to explore other areas the FDA regulates.
Hi, I'm Aaron Harman and this is inside out quality, a podcast about real life events and experiences shared by our guests of when things have gone wrong, and how we can learn from them to build better products, companies and improve lives through an effective quality system. Condensed milk was a popular choice for Feeding Infants in the early 1900s. Here's a quote from the Jeffersonian newspaper in 1909. Ordinarily, a baby thrives pretty well for its first year on condensed milk, which is generally regarded as wholesome if better brands be used. This wasn't true at the myrtle baby home in East Providence, Rhode Island. Between June and November of 1909 22 of the orphaned children care for the home mysteriously died. The reported causes of death ranged from convulsions, to indigestion to general weakness according to the authorities. These were young babies dying, 11 of them were younger than three months old. An investigation by the Secretary of State Board of Health Dr. Koop discover the cause. The deaths were all traced back to a single case of condensed milk contaminated with what they call a highly deleterious bacteria. The Topeka daily State Journal reported further that the milk brand had labeled itself as conforming to the Pure Food and Drug Act. This was a law passed in 1906 because of poor food products and narcotics and food and medications being sold without disclosing what they were. It's unclear when how or where the milk became contaminated. No authority had provision over orphanages in that time, the coroner found no proof of negligence on the caretakers part, and the conditions to the home are good and only physician prescribed medications were used. The result of the inquiry by the coroner was a recommendation at the state supervises and regulates orphanages, which resulted in a law passed in 1809. But what about the milk? This would be unheard of today? How is today's food regulated and kept safe. And that's why Kate hire is here to help us understand she is an expert in food quality systems. Welcome to Inside Out quality.
Kate Haiar:Kate, thank you for having me on today a little bit about myself. I graduated from South Dakota State University with a bachelor's degree in food science and from there have worked from farm to table from sugar beet harvest and sugar making all the way to frozen pizza manufacturing. I currently am a quality director with Red River commodities up in Fargo, North Dakota. And I work once again from farm to fork on everything sunflower so we do RAW commodity processing of some flowers and other specialty seeds will roast them and then we also do make some finished products with them including our specialty line of SunButter, which is an allergen free peanut butter alternative.
Aaron Harmon:Do you get the sample food while you work in the space? On occasion,
Kate Haiar:I do not. Not very frequently I'm more office and regulatory focused. So I do a lot more on the paperwork documentation side. But some of our quality techs it is part of their role once an hour once every half hour depending on where they're located to sample product to ensure that it is tasting to the flavor profile that we're looking for. I'm jealous
Aaron Harmon:of that. My work career has been in infectious disease labs. So I was very frowned upon to sample that stuff.
Kate Haiar:Yes, yes. Right now it kind of gets a little bit boring with the sunflower seed side of it because it is just one kind of more specialty food group. But at my pizza manufacturing previous life we would have to sample anything and everything that went into pizza manufacturing and so you could if you were okay with cheese pizza, you could probably eat cheese pizza every day for lunch,
Aaron Harmon:you will get a spike in people applying for food positions.
Kate Haiar:It is a one thing that no one ever realizes in the quality department usually it comes with the perk of having to sample whatever you're eating
Aaron Harmon:I need to get a job for receipes
Kate Haiar:I would highly recommend that sugar factory we also had to sample sugar every day so that that's another one you sample the product that you make no matter what
Aaron Harmon:oh man. So how did you get into the food quality is basically how did you make that transition after SDSU
Kate Haiar:so it really started at the sugar factory I got brought in as a position called the assistant chemist and I was really a reports and laboratory person working with wastewater which has nothing to do with food but still a quality and regulatory aspect of you can only put water back into an environment if it is at or above the cleanliness standards of that water source did wastewater treatment for part of it and then really got into liking the checks and balances in preparation for our first safe quality foods or SQF audit at the sugar factory and from there I just flourished and love just doing everything on the call Beside I've got my new position with the Orion Food Systems located in Sioux Falls, did everything on the quality in there from working with the technicians all the way up to doing quality management for the entire system there and it was anything and everything quality and food. I've just enjoyed doing it. And I kind of specialize in the regulatory aspect of it. So what FDA rules what USDA rules what government agencies affect your quality system, and then how that quality system also needs to meet your third party regulatory audits of I'm gonna throw a lot of acronyms out there, but SQF BRC GFSI? S, those big branch third party audits to ensure your quality system is safe.
Aaron Harmon:So I know very little about food regulations is thinking about that. No, had there been ones that have really impacted the food industry.
Kate Haiar:The end all be all original of food regulations started in 1906. With the original Food and Drug Act, Teddy Roosevelt actually was the president to kind of put this into states it prohibited interstate commerce of misbranded or adulterated foods, drinks and drugs. So it was the first time that there was a solid act put into place to keep food safe. On the same day in 1906, the Meat Inspection Act was also signed into law. So there's two big food laws that went into place at the same point. And the meat inspection law was kind of based off of Upton Sinclair's The Jungle, and his eye opening reveal of everything bad with the meat industry. So this was the United States Government way of correcting those issues that were just brought to the forefront. And then it continues on. So in 1933, there was the first recommended and completed revision of the 1906 Food and Drug Act, and it started a five year battle to get what is now known as the FDA. So it really kind of battled back and forth between government and legislation to figure out how they want to define what is underneath the FDA for regulations. Those were two big ones to start it and then you have in the 1950s generally regarded as safe or grass for food additives started to be come into effect and the 1960s there was a Child Protection Act and fair packaging and labeling act. All of these started to require new definitions of what can be on a label for food. The child protection acts mainly looked at Toys and what ingredients could be made into toys. Because pre that you could you name a random substance and a toy and deem it safe. But yes, exactly. The fair packaging and labeling acts started the standardizing of labeling on ingredients and food information back in the 60s. From there, it kind of stagnated until the 1990s. So in 1990, is when the nutrition labeling and education act took place. And that's where food pyramid started to become a big thing and education of our communities and country on what is actually in your food and how to read a food label and trying to educate people so they understand what the substances that they're putting in and why American cheese is no longer called cheese and all those things that a lot of people don't didn't realize what went into making food. That was a big push through and a big act of standardization across the board. And then it's ramped up again in like 2002 and 2003. There was the trans fat labeling laws in 2003. So now trans fats mean good to hear the good side and bad side of all those and those have to be on labels. And then in 2002, it was the Current Good Manufacturing Practices became enforced in the manufacturing and Food and Drug devices era. So it was a big push to get everything standardized. And then in 2004 allergen labeling became a big push. So allergen education the top eight what does that mean? How do we need identify those products on a label and the standardized in of identifying allergens on the label that we now know today? And then the last big push that is still working its way through the legislature because they did it in phases, but the initial passing of it was the food safety modern isolation act of 2011. And this push has up preventative controls, all these big parts of the current quality and food safety sector that is required, made it standard across the board. So it really pushed everything as far as the human food safety side to the forefront. All these laws kind of work on top of each other. They're all written into the same code, or same sector of food legislation or of the government of the US government regulatory aspects. It's all just been adding on and on and on to each other to really help ensure that people are safe across the board.
Aaron Harmon:That's a that's a great overview. Yeah,
Kate Haiar:it's it's been a century plus coming of food safety, but that's how we went from, you know, Coca Cola actually containing cocaine to Coco Cola, zero sugar. It's an evolution.
Aaron Harmon:In the story that I go through in the intro. This is from 1909 incident at a orphanage, children pray to totally died from condensed milk contamination, is that something we could ever see happen today? Like it's highly unlikely.
Kate Haiar:The likelihood of that happening today. If it is a facility that is FDA registered, contains a hands up plan or Hazard Analysis Critical Control Point Plan, and follows the Food Safety Modernization Act regulations, the likelihood of this happening is going to be like one and a mil. So looking at condensed milk, the proper the system flow that it would require to make that you would have to keep the milk to a certain standard, concentrate down the fluids and do it if it was sweetened to add the sweetener, put it into the packaging, seal the packaging and label it and distribute that would be your set steps you would need to take and looking at when it was happening and how it went through. I'm going to assume and I'm just making as best of a college educated guess as I can that they did not either heat the milk properly, or they did heat the milk to the right point to get pasteurization to remove as much of the bad bacteria as possible. But then there was a contamination if they sweetened it at all, or anything they may have added in or potentially dirty packaging on the back end. But looking more at that story from 1909. My guess is they didn't follow true pasteurization. And there was a disgusting bad milk bacteria that is known to cause damage to anybody who ingests it. And it is more fatal than it is just severe illness. If you were to ingest newspapers back then reported it as a highly deleterious bacteria. Do you have any ideas which one it could have been? Or which ones? Ah, yeah, it'd be Mycobacterium tuberculosis, okay. That would be my guess on the bacteria. That it would be it is one that is killed off very easily with pasteurization. However, it does require a longer pasteurization than the standard. Okay, so yeah, if had gotten in there, and they weren't prepared for that, it could have gone wrong. There's multiple links to this bacteria throughout the world history that has caused death disease, and then all the bad stomach illness, diarrhea, vomiting, everything terrible. So my guess would be my Mycobacterium Tuberculosis. If I had to put a wager on it in Vegas, or foodborne illness is still common today in the US. foodborne illnesses are less common now in the US than they had been previously. However, they are more reported on the ability to report a foodborne illness has gotten a lot easier. And the FDA does do a lot of investigation on it being on my end, as a quality director, I've actually had to have conversations with FDA from people reporting that they got ill off of claiming it was the product that I may have produced. Most people don't understand that timeframe that it really does take for a foodborne illness to really affect you. So they always associated back to their last meal when really it could be up to 24 to 48 hours is when symptoms will start to
Aaron Harmon:show. Now we'll take a quick break to hear from one of our sponsors.
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Aaron Harmon:So for the food industry going forward, do you see new regulations on the horizon or new changes in the industry to make food safer? Or is it still just the rollout of the FISMA and Hatha programs,
Kate Haiar:so FISMA is constantly ever evolving. I think the biggest part of FISMA came through in about the 2015. When that got passed, the 2015 update on it got passed to ensure that every facility had a preventative control qualified individual on staff, that person's job is solely to ensure that everybody is following the regulations and ensuring we're following our food safety practices in the 2015. Passing of an update to the FISMA regulation really just started that FISMA is gonna stick around forever, and it's going to constantly evolve with a new potential issue or concern that they're seeing. So the latest update to FISMA, that got passed in 2019, but it's taking effect this year, is the foreign Supplier Verification Program. So now, anybody who uses a foreign supplier has to have additional verification steps in place to ensure that the product that we're receiving there is at the standards of the recognized food identity for the FDA. So however, whatever product you may receive in so for instance, my seed company will roast pumpkin seeds or pepitas for customers. And so those are sourced, not big pumpkin growing operation in the US. But there is in China and in Mexico, and a few other nations that would then require us to have a foreign supplier verification program in place. So these suppliers, I now have to make sure I have documentation. And it's suggested that we do a on Site Audit once every three years or five years, but that we're actually going and visiting and verifying that this facility these suppliers are producing product to safe quality food standards
Aaron Harmon:banner, you start getting into like coconuts and tropical foods, so you can go do some field audits.
Kate Haiar:If only my facility is actually known for being peanut and tree, nut free, and coconut, unlike most people believing that's a fruit it's actually deemed not by the FDA. So I will not go anywhere tropical for coconuts, but I am hoping for a few of our spice suppliers to have a nice sunny place to go visit at some point
Aaron Harmon:that is like one of the secrets of being in quality and regulatories you get to travel to some cool places. Yes,
Kate Haiar:that is definitely true. Most of our domestic people are not so fun in location. But I have gotten to go to Denver and then up to the upper peninsula of Michigan to verify suppliers and ensure compliance. So there is some upside of being everybody's nuisance, that is usually what quality gets called.
Aaron Harmon:We're just assuring their performance,
Kate Haiar:we are making sure that you guys are gonna not have an issue on production. So production can focus on production to make sure that they're producing the products making as much products in the shortest amount of time as possible and being as efficient as possible by having quality products coming in
Aaron Harmon:excess something goes wrong. That's a huge disruption. Yes.
Kate Haiar:And on the food end, those kinds of hiccups on the food end take weeks to recover from so from a supplier having an issue which has forced them to recall or withdraw products from the market can cause hiccups up to I'd say about six to seven weeks throughout their entire supply chain. So if a food company has to recall a product, they have to contact their customers who then their customers have to identify what product that could have potentially went into or became part of and then they have to then withdraw all of that product. And then if they're producing something for somebody else that goes into something You can just cause a massive ripple within all of a supply chain that will take months to get back to normal. And some a lot of food facilities that actually is shut down is what it ends up being it ends. If the food safety spectrum causes a withdrawal or recall that can be so catastrophic to the specific site, there's been a lot of people that it gets shut down on, which is unfortunate.
Aaron Harmon:Do you have any tips or tricks or advice for those in the industry?
Kate Haiar:I guess from a food side, my biggest thing on tips or tricks is to always be learning and always sign up for regulatory reminders from your local government agencies. I get an email every day about something new, whether it falls underneath the FDA or the USDA spectrum of new regulations coming into play. So my company right now is very forward thinking on allergens. And so now that sesame seed has officially been signed into law that it is going to be a recognized allergen come 2023 on all labeling. We've already been proactive and have worked to either eliminate or properly identify any products that contains that,
Aaron Harmon:cause if it's an allergen, that could trigger a recall right?
Kate Haiar:Absolutely any, any unidentified allergen can trigger a recall instantly that is, within the sense, allergen labeling became a big thing in the early 2000s. And properly identifying it and traceability of allergens. All those coming together have caused the most amount of recalls within the last five years, all because of improper labeling on the package that either contained allergen or identified an allergen that it did not.
Aaron Harmon:So one thing that I'm I'm hearing to this whole conversation is in GMP, we have a thing called cGMP. The C is for current. And that's because as we learn more and understand as the science develops, we can implement new things to continue raising that bar of safety for customers and, and helping us get our product out there without causing concerns. For sounds like it's very much alive and well in the food industry.
Kate Haiar:And 100% is GMPs in the food industry, they've decided to drop the sea but it's forever evolving and changing and SQF BRC these other organizations that help audit and ensure people are making food to the safest quality possible they will come in and ensure that you're following it but every year to two years they update now it'll require more risk assessment out of a facility for why they may or may not allow wedding bands should be in a production area or risk assess why you double sanitize your hands prior to putting on gloves and then sanitize your hands again before you go into a production room. So there is always a science that's coming in and developing and growing. There is quite a bit of scientific research that go into why GMPs are what they are so for instance, my company also has a wild bird food division and so in the FDA s eyes and and our third party SQF audit eyes is it's still food and might be feed for animals but it still could be part of the food chain. So you still have to have hair nets and beard nets or risk assess why they aren't required for your manufacturing area. Previously in my pizza manufacturing days, we had a little bit more hands on depending on what the topping requirements were we can automate everything so some things were ham top like tomato clumps because our equipment would break them down too much and turn into a tomato pulp and no one wants a pulpy tomato on their pizza. So our employees who were hand topping would not only have to wash their hands and have gloves smocks hair nets beard NetFlow whole standard guard, but they'd also put on these vinyl sleeves are what we call them and then went from wrist to about just above elbow and they could easily be wiped down with a sanitizing solution to to ensure that there wasn't any potential bacteria contamination coming on to the product.
Aaron Harmon:I was the consumer I really appreciate that.
Kate Haiar:Anybody who is bad as it sounds, your mass manufactured frozen pizzas or dried drink mixes or anything like that is going to be potentially more safe than your local restaurant. And that's only because of how many regulations have been passed even within the last three decades on mass food manufacturing versus your local state health department's The only thing regulating your restaurants now, not just regarding restaurants and I'm not saying don't eat at them by any means, but your likelihood a foodborne illness is going to come from either your home and mishandling a product, or a restaurant versus your mass produced products.
Aaron Harmon:And that's that's a good thing. Let's see that as the technology, what we're learning, everything's getting better, and the risk is decreasing in areas now.
Kate Haiar:For sure the risk in mass food manufacturing for foodborne illness there. I'm not saying there isn't any, there always is going to be some but as long as everybody follows their hazard analysis, critical control points and their preventative controls and everything else that the FDA says a food manufacturing facility needs to have in place that the risk of that is going to be so low that it isn't going to be an illness issue. It's going to be more of Oh, my stomach's a little upset. But I'm okay. issue. Yeah.
Aaron Harmon:Well, thank you for being on the show. Absolutely. Thank
Kate Haiar:you for having me.
Aaron Harmon:We also want to thank the Rhode Island Historical Society for their help with this episode. historical societies help preserve history and we are grateful for them and their work. Stay tuned for our next episode. We hope you enjoyed this episode. This was brought to you thanks for South Dakota biotech Association. If you have a story you'd like us to explore and share, let us know by visiting www. SD bio.org. Also, if you live in the Sioux Falls area, check out quit a local Quality Assurance Professionals Network. You can find out more about QUIBIT by clicking on the link on our website too. Thanks for listening