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Season 7 Episode 3 - A Closer Look at the Food Safety Modernization Act (FSMA)

Posted by Rachel Miller

Episode Show Notes

Episode 3 features FIBR Food Safety Council Lead Trainer Bill Huntley. Bill discusses the Food Safety Modernization Act (FSMA), its impact on small and medium-sized manufacturers (SMMs), and the steps SMMs can take to ensure their compliance.

Bill Huntley is Lead Trainer of the FIBR Food Safety Council and Owner of William Thomas Huntley & Associates. Bill has been consulting since 1997, maintaining the same goal over the years – to meet his clients’ needs in food safety and quality through long-term relationships. Bill has three Associate of Science Degrees in Animal Science, Dairy Science, and Livestock Production; and a Bachelor of Science degree in General Agriculture. After graduating, he worked for 14 years in the dairy and produce industries. During this time, he created and conducted training programs in food safety, HACCP, quality, sanitation, inspection, and laboratory testing. Over his 25-year career, Bill has developed strong relationships with both industry and regulatory entities. He has active memberships with the International Association of Food Protection (IAFP), American Society for Quality (ASQ), and Food Safety Preventive Control Alliance (FSPCA). And, he continually works to build and maintain his relationships with the California Department of Agriculture Milk and Dairy Foods Branch (CDFA-MDFB, Food and Drug Administration (FDA)), United States Department of Agriculture (USDA), and Centers for Disease Control and Prevention (CDC). Education has been and will always be key for Bill’s company – whether it be his own education or his clients. Bill has taken several courses to upgrade his background and has been certified as a: Lead Instructor for the Food Safety Preventive Controls for Human and Animal Foods (FSPCA); Lead Instructor for the Foreign Supplier Verification Program (FSPCA), Quality Auditor (ASQ), Third Party Food Safety and Quality Auditor (YUM! Brands), Advanced HACCP Auditor (BRC), HACCP Auditor (USDA), Trained Auditor (BRC), Licensed California State Pasteurizer (CDFA-MDFB), and Trainer (ServSafe). 


00:01:16 - Introductions

00:03:06 - Definition of Food Safety Modernization Act (FSMA) and why Congress enacted it

00:05:25 - How FSMA has evolved since it was signed into law in 2011

00:07:16 - Phased approach to implementation 

00:11:33 - Application of FSMA to food manufacturers and to what degree

00:12:31 - Definition of PCQI

00:16:15 - Discussion of preventative controls for human and animal food

00:22:38 - Impact of FSMA on small and medium-sized manufacturers

00:26:31 - Compliance guidance for small-sized companies 

00:26:59 - Benefits of Qualified Supplier Program

00:29:54 - Potential consequences of noncompliance with FSMA

00:32:16 - First five steps to ensure compliance


Gregg Profozich [00:00:02] In the world of manufacturing, change is the only constant. How are small and medium-sized manufacturers, SMMs, to keep up with new technologies, regulations, and other important shifts, let alone leverage them to become leaders in their industries? Shifting Gears, a podcast from CMTC, highlights leaders from the modern world of manufacturing, from SMMs, to consultants, to industry experts. Each quarter, we go deep into topics pertinent to both operating a manufacturing firm and the industry as a whole. Join us to hear about manufacturing sectors’ latest trends, groundbreaking technologies, and expert insights to help SMMs in California set themselves apart in this exciting modern world of innovation and change. I’m Gregg Profozich, Director of Advanced Manufacturing Technologies at CMTC. I’d like to welcome you.

In this episode, I'm joined by Bill Huntley, the Food Safety Council Lead Trainer for the Food Industry Business Roundtable. Bill discusses the Food Safety Modernization Act, its impact on small and medium-sized manufacturers, and the steps manufacturers can take to ensure their compliance.

Welcome, Bill. It’s great to have you here.

Bill Huntley [00:01:13] Hey, it’s great to be here. Thanks for inviting me.

Gregg Profozich [00:01:16] Oh, you’re very welcome. So Bill, can you please take a minute or two and tell us a little bit about yourself?

Bill Huntley [00:01:21] Sure, I’d be happy to. I’ve been in the food industry in California, specifically Southern California/Los Angeles area now, for over 40 years. Twenty-five years ago, I started my own consulting company, William Thomas Huntley and Associates. I have been doing food safety and food quality for some of the biggest names in the food industry from Nestlé, to Unilever, to Yum! Brands – Taco Bell, Pizza Hut, and KFC – and I’ve worked with some of the smallest companies. It’s always been to help people come into compliance with what the needs of their customer base is. I come to you today… Even though my company is a consulting company, I come to you from our friends at FIBR, Food Industry Business Roundtable, who is 33 years in the industry. They’re a business partner of CMTC. What they try to do is, within the Los Angeles area, they invite food manufacturing companies to come in and take classes to try to find the best ways to do things within their industry. In that group, I actually came in to work with their food safety side, which is called the Food Safety Council. In the Food Safety Council, we offer courses, and we do them in-house, and then we also do training online. We offer food safety classes like HACCP, Hazard Analysis Critical Control Points, PCQI, Preventative Controls and Qualified Individuals training, foreign supplier verification program training, so we have all of these courses that we offer, and I think would be useful.

Gregg Profozich [00:03:01] Well, thank you for that, Bill. You have an impressive background, and I’m looking forward to our conversation.

Bill Huntley [00:03:05] Thank you.

Gregg Profozich [00:03:06] So, we’re here to talk about the Food Safety Modernization Act and what not only SMMs in the food and beverage industries need to know but also some things that consumers might want to know. I read a statistic that there are an average of 325 food recalls each year, almost one per day. Everything from peanut butter to pet food, organic strawberries to frozen shrimp, Skittles to seasonings to bagged salads have been recalled in the last year. According to the US Food and Drug Administration, about 48 million people in the U.S. get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne illness. Those are some sobering statistics. If I understand correctly, the Food Safety Modernization Act was enacted into law to deal with issues of foodborne illness, with a focus on prevention. So let’s get into it. Bill, what exactly is the Food Safety Modernization Act, and why did Congress enact it?

Bill Huntley [00:03:55] Food Safety Modernization Act, acronym FSMA, as stated all over in newspapers and periodicals and even within the FDA, is a program put together to reduce the amount of food poisoning in the United States today. Back in 2017, we had had some of the largest food poisoning recalls ever, and the government wanted to make sure that we had something in place, so the FDA went back to Congress for funding to put a new system in place. And that system was the FSMA. It had several different points to it. It keeps evolving into new points. Each one of these is to improve what they’re doing. President Obama actually signed it into as a law in January 4, 2011. So they keep working, they keep putting things out for public comment, they try to start and finish and keep things going. And the concept behind it is finding a food safety problem before it happens instead of recalling it after it happens. Ultimately, the new Food Safety Modernization Act is a proactive group of programs as opposed to a reactive group of programs.

Gregg Profozich [00:05:25] You said a moment ago that the FSMA was signed into law back in 2011. Why is it relevant to talk about today? How has it changed or evolved?

Bill Huntley [00:05:35] Well, we’ve gotten multiple programs within the FSMA. Just to name the group of programs, we would have agricultural water, which means the water used for watering plants for human consumption that don’t generally get sanitized with a sanitizer and don’t get cooked. The fear was if something was in the water, it would contaminate the produce. That fell under the produce rule. Then accredited third-party certifications, current Good Manufacturing Practices (GMP), and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for human food. The same thing for animal food. Food traceability, Foreign Supplier Verification Program (FSVP), laboratory accreditation, mitigation strategies to protect food against internal adulteration – which is the latest one being trained on right now for the food industry – sanitary transport standards for growing, harvesting, picking, and holding of produce – that’s the produce rule – then Voluntary Qualified Importer Program (VQIP). You’ve got all these programs which have been brought into the public’s realm and the responsibility of people producing, storing, shipping, and delivering food to the public. You have all of these programs put together to help prevent things from going wrong before they go wrong. Hopefully, once everything’s in place, we’ll have less of a chance of getting the number of food safety issues that we have in any given year.

Gregg Profozich [00:07:16] I hear you saying that there’s a phased or a sequential implementation, if you will. Is that what I’m hearing? Across those different things: preventative controls, and third-party certification, and sanitary transportation. You mentioned a bunch of things a moment ago. Those weren’t all enacted into law in 2011, required on the spot, or were they?

Bill Huntley [00:07:36] Those have been done at different times because they have so many pieces to them that they needed to be written, and reviewed, and gone over with the public, with corporate structures, with everybody in academia, comes back to the FDA, they go through it, they make their changes, they come out, and then it needs to be trained on. What we have is a group called FSPCA, Food Safety and Preventive Controls Alliance. What they do is they put together training materials so that these programs can be trained on. As I said before, mitigation strategies to protect food against internal adulteration is the latest of the programs being put in place with the companies to follow. The strategies there that you’re looking at and figuring out what is your culpability, what are the issues at your facility, or what you’re doing, might be to a terrorist doing something to your product or to a disgruntled employee. Do you have programs in place? Those kind of things. This is the latest one, and it’s probably the one that’s going to be the hardest to really get up and running because people have not been doing this before, so it’s going to be the hardest. In general, a lot of the other stuff has gotten done before, but not at this level.

Gregg Profozich [00:09:05] Got it. I hear you saying that the bill was signed into law back in 2011, and it’s been going through a phase review cycle between industry, and academia, and the FDA, and the other agencies. They’ve been rolling them out and putting them into enforcement. It’s not fully implemented yet or fully enforced by extension. Is that correct?

Bill Huntley [00:09:25] Correct. Not fully enforced. Some parts are fully implemented but because of the size of a company or their ability financially, they’re given a little more time to put things together. Good Manufacturing Practice (GMP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) are the ones that have been really worked on for both human food and animals. They’re the most widely taken care of because they’re the ones that are the most utilized in the food industry.

Gregg Profozich [00: 09:55] Smaller companies have more time to adjust to the new regulations and make sure they’re up to the standards?

Bill Huntley [00:10:00] Yes. Generally speaking, as things are rolled out, smaller companies, and then you get into qualified companies. A qualified company is a company that meets certain regulations for these programs. Either financially, it’s too small, or they put up a bakery product that’s fully cooked, and it’s small, and it’s not going to do a great deal of contamination. Remembering that the FDA looks at things as to how much contamination can get out there and cause a recall, something that sold within the city limits of Los Angeles is not going to be as critical as something that’s going to be eight states wide.

Gregg Profozich [00:10:47] Got it. If I am a Northern California producer of some baked good in the small town of Yuba City, the chances of any contamination there becoming a major problem causing a recall are much smaller than if I am a producer in New York City?

Bill Huntley [00:11:05] Right. If you’re Bimbo Bakeries, the FDA is looking and saying, “All right, Bimbo’s big,” and we could end up with a major recall. Bimbo is going to be handled differently than a small bakery that’s a manufacturer. The difference would be a Porto’s as opposed to another company where the bakery is a bakery and not a manufacturing plant. It would fall under the wholesale regulations.

Gregg Profozich [00:11:33] Got it. That was my next question. I think that’s a perfect lead-in there. Does the FSMA apply to all food manufacturers and to what degree?

Bill Huntley [00:11:40] Actually, the FSMA does apply to all manufacturers. However, for each one of the rules, there’s specifics that say whether or not they have to follow that rule because of what they do and how they do it. Companies that are generally considered under the USDA for meat, poultry, eggs, and such, do not have to have the PCQI, which is the preventative controls regulation, because they’re doing a full HACCP that’s inspected by the USDA. In addition, juice facilities which are FDA inspected with HACCP plans do not have to have a PCQI because they’re inspected for good HACCP programs and because they’re a sterilized product.

Gregg Profozich [00:12:31] Okay. Just for context and to make sure we’re all following, PCQI stands for what again?

Bill Huntley [00:12:36] PCQI is the acronym for Preventative Controls and Qualified Individual, which is the food plan requirement by the FDA. It is in the current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for human food. Within that, you have to have a person that is specialized, which means that a person is there that’s going to write the specific program. The trainings that everybody goes through is called PCQI training.

Gregg Profozich [00:13:10] It’s the individual within an organization?

Bill Huntley [00:13:13] Yes. The PCQI is a person within your company, or it could be a consultant. This person or consultant has background and knowledge that allows him to be able to put together a food safety plan as the FDA requires and understand what the ramifications are of putting together the food safety plan.

Gregg Profozich [00:13:38] Okay. Your PCQI puts together your food safety plan based on the rules, and regulations, and requirements of the law vis-à-vis your unique production facility —what you’re producing, how you’re doing it, what materials you’re handling—because FSMA applies to everybody, I heard you say, but not every rule or program within FSMA applies to everybody to the same degree.

Bill Huntley [00:14:02] Right. One thing I might note for people that you have out there that might be wanting to do this—they’re smaller companies, and they know they have to get it done. Right now, last meeting we had with the FSPCA, they informed us that the biggest amount of people that aren’t doing it or that there were big mistakes within the programs. It’s important to get them done correctly. The FDA never goes into anything blindly. They have program builders on the FDA website. There is a program builder for the preventative controls food safety plan. Actually, you put in your information, and you just keep putting in information, and it actually builds the program for you. People don’t have to really go into this blindly. There’s a lot of things out there within the FDA website that will help them to create this program which we call the food safety plan.

Gregg Profozich [00:14:59] I want to get in a minute into the seven rules and really get down into the depths. But just to make sure I have the context and the whole background on this, FSMA was enacted in response to some foodborne illness issues and outbreaks that we had back in the 2005-2010 timeframe. It was enacted by Congress in 2011 for purposes of much stronger focus on prevention. Within the FSMA, there are seven different programs that we’ll go through in a minute. Each of those programs, although they’re part of FSMA, may or may not apply to a given manufacturer. Depending on the foods that I’m making, and who I’m making it for, and how it’s normally processed, certain aspects of each of these programs or rules may or may not apply to varying degrees?

Bill Huntley [00:15:49] Correct.

Gregg Profozich [00:15:49] To make sure we have an effective plan, a food safety plan, we’re going to need to have a PCQI. A PCQI is a Preventative Controls Qualified Individual, someone who has been trained, either an employee or consultant, who can put together the food safety plan. That person is free to use some of the tools that the FDA has published on their website for the program builder. Does that summarize it so far?

Bill Huntley [00:16:13] Yes. Very good.

Gregg Profozich [00:16:15] Okay. Let’s get into the details then and make sure we understand the seven programs. Number one, preventative controls for human and animal food. What’s that all about? Who does it apply to? What are the nuances?

Bill Huntley [00:16:25] All right. Those are two separate ones. The idea here is that we didn’t have these before. They are the creation of a food safety plan, and these are specifically written into this part of the current Good Manufacturing Practices. We used to have Good Manufacturing Practices required by the FDA. In those, it told us how to do things specifically, what they were looking for when they came out to your facility. Then what they did, they expanded that and put the risk-based preventive controls within those current Good Manufacturing Practices. Then they expanded it again to cover both human food and animal food. In doing this, they have created two brand-new things. Back in 2017, they were enacted. They’ve had a while now that they’ve been working on these. We’ve had a lot of training and the folks are getting much better, but we still have issues because smaller companies that come online don’t understand what they really need and what they should be doing. Then along with that, we had the transportation rule come into place, the sanitary transportation rule. Basically, what it is, no matter who you’re shipping or what you’re doing, if you’re carrying a food commodity, you can’t carry things on the truck that would contaminate the product. You can’t carry raw chicken on the same truck that you carry produce. You can’t take the risk of contaminating something without cleaning properly. It put in place specific things that need to be done to stay in compliance to this part, this program within the rules. Then we go into supplier verification. We had Foreign Supplier Verification Program, which included the voluntary qualified importer program and also accredited third-party certification. Basically, what the FSVP, Foreign Supplier Verification Program, what it says is that if you’re going to import something from outside the United States into the United States, it is your responsibility as the person importing it. It is not the responsibility of the person outside the country. An FSVP, which is a person within a company or a specific group of people, they take care of what’s coming into the country. They need to make sure that their suppliers outside the United States, they’re following all the same regulations as required by the Hazard Analysis and Risk-Based Preventive Controls rule. It doesn’t matter where you are in the world. Then your responsibility as the FSVP is to make sure that you have a third-party certification. You could use an FDA or somebody else, or you can have a person that’s accredited third-party company to do the audit in a foreign country. It also includes that if you want to have records to review before they ship it in. There’s a lot of different ways you can make sure your imported goods are being produced safely. That’s the most important thing. Then within that same rule, we have the voluntary qualified importer program. What that means is that these people are automatically doing exactly what the federal government requests. If you look at Canada, Canada has many of the voluntary qualified importer programs. It all works together. If you want to make sure that you can ship things in here without problems, then you would file for that with the FDA and current Good Manufacturing Practices rules. We have a requirement for a recall program. Recall is handled under that. Now, most people will say food traceability—isn’t that recall? Food traceability falls under recalls, but what the government wanted to make sure to do is that this is a food traceability program under the FDA. That means you randomly pick things, and go out, and make sure you can retrieve what you say you shipped out and that you’re within 99% ability to find that product. Laboratory accreditations we’ve had in place, especially in California and other states like New York. Laboratory accreditations have been required for several different products. But now the FDA just put a program in place that covers that specifically, as I spoke about mitigation strategies, protect food against internal adulteration, also food security. Those kind of things have several names for that. But that program is the latest, and it’s covering the most things. Now, actually, one that was back long before the programs that we have in place now, even before 2011, standards for growing, harvesting, packing, and holding produce is probably one of our oldest in place. We’ve always had this program. It’s changed many times in the past number of years. It specifically says what you have to do to be in compliance for these kind of things. Now, within that, for those that don’t know, is the sprouts rule. That’s for growing green sprouts. They’re considered a very high-risk product. They had their own little rule that says what and how the sprout grower has to do to be in compliance within the produce rule. Agricultural water used to be in the produce rule, but they wanted to take it out and make sure that the producers were actually following very closely rules.

Gregg Profozich [00:22:38] Okay. Now we understand a lot more about the details of the various rules. We understand what the FSMA is all about and how it’s being implemented over time. Enforcement is coming at some point as each of the rules are verified and accepted by the FDA and the different review bodies that go through that process. What is the impact of FSMA on small- to mid-size manufacturers? If I am a 30-person company making some food product, what does it mean to me?

Bill Huntley [00:23:04] All right. You look at what they’re calling things. We say there are very small businesses. This means a business, including any subsidiaries or affiliates, that averages less than 1 million, adjusted for inflation, per year during the first start date. This is facilities solely engaged in packaging and holding activities of ready-to-eat products. Then in January 27, 2020, certain facilities would qualify as secondary activity farms. So, farms were given a later date to start, especially smaller farms. Then we had small businesses as opposed to very small businesses. Small businesses, including any subsidiaries and affiliates. Now remember, the first one, we said it was just a cash amount. We said a million dollars made them this. The second one, a small business has fewer than 500 full-time equivalent employees. Their start date was September 18, 2017. You notice they were supposed to have something in place before the very small companies. They had extended compliance dates for facilities solely engaged in packing and holding activities for the raw commodities. Then we have compliance date going from January 28, 2019 for the secondary farms. If you had more people working for you on a farm—you might be producing a big lettuce crop in the center of California—you might have 50 to 150 people working part-time, full-time, and they would fall under this. They didn’t have to be in place until 2019, January 28th. Now, in addition to that, they would have to have things in place that added to their food programs and that preventative controls rule or the produce safety rule. But they do have to have specific things in place for food safety. That compliance date was September 18, 2017. They would remain the same on that, but their requirement was that they didn’t have to have the same thing as a company that was actually producing products. Then a business, including any subsidiaries and affiliates, the average is equal to or more than $1 million, adjusted for inflation, per year during the three-year period preceding the applicable calendar year in sales and that has more than 500 full-time employees or equivalent, the compliance date was September 19, 2016. You’ll see that that was actually before 2017, but they had pushed that date out. They’ve adjusted for these numbers back and forth. They really at this point still just go out and do a lot of training audits for a lot of the programs when they go in. Then January 26, 2018 was for companies that were just doing packing and holding activities for raw agricultural commodities, farms, those kind of things. Those are all in place for this.

Gregg Profozich [00:26:31] Okay. These are the dates, and the various rules, and when they apply to various sizes of manufacturers. But if I’m a small 20-person company, what do I need to have? Do I need to have a written plan? Do I need to have seven written plans? What do I need exactly to do? What are the steps I need to take?

Bill Huntley [00:26:51] If you are making less than a million dollars, you can apply for the Qualified [or Approved] Supplier Program. It doesn’t mean you’ll get it, but you could apply for it.

Gregg Profozich [00:26:59] What does that do for me?

Bill Huntley [00:27:00] Well, that would say that you didn’t have to do a formal food plan. The PCQI regulation was waived for you because the smaller you are, the more chance you have. If you don’t make a million dollars a year and you’re doing a hot sauce or something out of your restaurant that you package up and you sell, you’re really not going to have a major food poisoning issue worldwide; you’re going to have a local issue. Again, they take these things in consideration when they’re writing these regulations. The issue would be that any manufacturer that has a million dollars or more would be seriously looking at having a PCQI. The larger you get, the more money you get, the more expensive food safety is for you.

Gregg Profozich [00:27:55] It makes sense because the more impact you can have on a larger portion of the population, right?

Bill Huntley [00:27:59] Correct. What’s changed now—you’ve seen it especially in the Los Angeles area—we have a lot more ghost kitchens. People are producing products in ghost kitchens that they weren’t doing before. Some of these ghost kitchens are becoming manufacturers without even knowing it. If they were to get caught… And then sell them on the Internet. This is the other problem. Where we said this was a local business, it’s actually getting to be a larger business and more complex going out to other places because if you’re selling stuff on the Internet, you don’t know if you’re selling it in Colorado or in California. The recall could be much larger than what we thought.

Gregg Profozich [00:28:47] Yeah. I have a relative who’s got a little hot sauce business he’s starting up, and he’s in Miami. Of course, all the family members on the west coast are ordering regularly because, well, we can, and we want to support him. It’s actually really good stuff. But just because it’s local Miami and his volumes are small doesn’t mean it’s a local Miami impact anymore with the Internet. That’s what I hear you saying.

Bill Huntley [00:29:08] That’s exactly it. A sprout grower in Sun Valley, California. He’s just going along his happy way, making his money, selling his sprouts. Everything’s going good. He gives me a call as the consultant and says, “Hey, I need to find something out.” I said, “What’s that?” He says, “What do I have to do because my sprouts are getting sold in Texas?” I said, “What?” He goes, “Yeah. Somebody put my sprouts on the Internet. They’re buying them from me. They didn’t tell me they were doing it. Now my sprouts are being sold in Houston.” There goes his local sprouts being grown and sold locally to Houston, which caused a question mark over the regulatory people.

Gregg Profozich [00:29:54] Right. A couple more questions here. What are the potential consequences of noncompliance with FSMA? We’re not at the enforcement stage yet at all, or we are in certain areas? What does the landscape look like?

Bill Huntley [00:30:08] All right. They have imposed greater scrutiny and tougher penalties if they fail to comply with the new food safety protocols. It used to be people hid behind corporate veils. If somebody died, it would be hard to pierce the corporate veil. After the peanut debacle a few years back, which is one of the main reasons this went into effect, which was the largest recall ever in the United States, it was found that the owner/CEO, his brother the accountant, and their quality manager, the two brothers got life sentences because of people dying and the quality manager got 10 years because they just did not show any remorse or good sense not to do what they were doing. They looked at it, they said, “We need this in place.” Now, things are in place that you need to look at these and understand what the possibilities of contamination are.

Gregg Profozich [00:31:11] Events around the world can change the importance of different aspects of the Food Safety Modernization Act and its implementation on you?

Bill Huntley [00:31:22] I think that what you’re going to see with the way that things go now and the ability of people to send things out immediately, we know that anything that gets photographed ends up on the Internet immediately. I think that as people find things, real things, real problems, I think that we’re going to see more and more issues crop up. I think that you’re going to see the government keep putting new things in place. Do they always really carry a lot of weight? No. Sometimes they can prove that under low emission that it’s not a true issue, but then in some cases, they come back and said that there may be an issue with specific things like plastics, with products that are getting into the food. But they’re not going to say it until they absolutely have proven it wrong.

Gregg Profozich [00:32:16] All right. Let’s put the shoes on the other foot a little bit. You’re a consultant that does food safety consulting. You’re now a small manufacturer. What are the first five things you’re going to do? You just inherited this farm, or you just bought this company that produces a food product. You’re making cookies. What are the first five things you’re going to do to ensure compliance? What are the practical steps you’re going to take?

Bill Huntley [00:32:37] Depends on the real size because, like I told you before, I could be considered a very small operator of a bakery product that is considered very low risk. If that’s the case, then I probably don’t have to do too much. But let’s say I’m a medium-sized place. I would say that first of all, I would specifically get training for the PCQI for food. I would look at what are the risks within my company now that I purchased? Where am I getting products from? Am I buying stuff from out of country and having it shipped in? Is there going to be an issue there? Have they already been doing it? Do they have an SFTP in place? There’s different food safety issues I’d look at depending on the company that it is. If you’re bringing in poultry from Thailand, then that’s going to be already inspected by the USDA. You really aren’t an FSVP if that’s what you’re bringing in only. You’re not going to need that. However, if I’m bringing in seasonings and powders from Mexico, then I need an FSVP in place to bring those in to make sure that they’re following what they say they’re following in food safety. Then I’d make sure that the… I understand it and if they don’t have a PCQI food plan in place, I’m going to put a food plan in place. If they don’t have FSVP but they are bringing in things, I’m going to put that in place. I’m going to look at what their intentional adulteration is. All the programs I talked about, you can bring them into place slowly, utilizing a consultant or utilizing someone in-house. You just have to hire a person. Again, that’s going to be an expense to your program. You really need to look at what the company earns, how you’re going to do it, and how you’re going to put it together. Now, not only do you have the government programs, but then we have the international organization called GFSI, Global Food Safety Initiative. The Global Food Safety Initiative sets up the parameters for certification of food safety audits and how to keep food safe in industrial situations—in manufacturing, shipping, warehousing, distribution. In that are specific groups that do food safety auditing, and training in food safety, and those kinds of things. We have SQF, which is Safe Quality Food; we have BRC, which is British Retail Consortium; we have Primus Foods in California, which is produce. We have multiple different auditing companies that handle specifically the GFSI mode of food safety. A lot of people have moved towards this. What they do is they will utilize these audits as audits that they accept for their companies and for sales purposes. The people at Sprouts, the people at Trader Joe’s accept GFSI audit schemes. To have this audit scheme means that you have SQF or one of the other groups. If you have the SQF audit group, then you get a certificate that says during these audits, we got audited for food safety, and sometimes quality but basically food safety, and within that, you got this percentage. You fixed everything that was wrong, and everything’s perfect. Everybody looks at it and goes ooh, ahh and then they buy your products. That’s why they want it. It makes it easier so everybody’s audited under the same criteria as opposed to being audited under different criteria. Because if you have a GMP audit, as we say, which is a food safety audit that’s set up under the FDA proposals, then it’s a little different than the GFSI. Most of the time, the ones that are GFSI changed the way they add some amendments in to cover the FDA statements. The government one will cost you either a person or a consultant on a basis to build these programs in place and have them going. It’s either going to be an employee program person or a consultant. Then, if you go with a third-party company that is your SQF or BRC, it could be anywhere from $3,000 to $5,000 a year to be in the certification program. All this comes under how much you want to pay.

Gregg Profozich [00:37:26] It’s definitely a risk/return conversation that you have to have to see exactly what the right level is based on the kind of food you produce, and how the rules might apply to you, and then what the various ways that you could implement and get to that level of safety that’s appropriate. Is that what you’re saying?

Bill Huntley [00:37:45] Yes, correct. A lot of insurance companies now are vetting companies before they will do any business with them because they want to know how food safe they are. A lot of these financial groups that go out and buy people, and put them together in packages, and resell them, are doing a lot of vetting to make sure that the companies are food safe before they even try to buy them or vet the products that you want to produce. Sometimes, it’s easier to be a distributor and warehouser than it is to be a producer at a manufacturing plant. Sometimes significantly cheaper to take your products over and have them co-packed.

Gregg Profozich [00:38:23] Okay. For the example I gave you—you just bought a company—but if you were a small company, you are half a million dollars in sales three years ago, and now you’re coming up on $3 million or $4 million or $10 million in sales. These rules and regulations now apply to you because you’ve potentially crossed some thresholds. I’m assuming the steps would be the same, right?

Bill Huntley [00:38:42] Yes.

Gregg Profozich [00:38:42] Number one, make sure you have somebody trained as a PCQI. Look at your food production processes. Look at your existing safety plans if you have any. Make sure you have them and make sure that they cover all of the identifiable risks. Look at your FSVP, your Foreign Supplier Verification Program. Look at your supply chain, make sure you have visibility to that. Then make sure you have a food plan in place that has the mitigation and the risk avoidance steps in it. I think that’s what you’re saying overall, regardless of the size of company or how you came to be involved in it.

Bill Huntley [00:39:13] Yes.

Gregg Profozich [00:39:13] Okay. Well, Bill, there’s a ton of great information here today. Thank you so much for joining me and sharing your perspectives and insights with me and with our listeners.

Bill Huntley [00:39:21] I was really happy to join you today. Thanks for the invitation.

Gregg Profozich [00:39:25] To our listeners, thank you for joining me for this conversation with Bill Huntley in discussing the Food Safety Modernization Act and its impact on small and medium-sized manufacturers. Have a great day. Stay safe and healthy. Thank you for listening to Shifting Gears, a podcast from CMTC. If you enjoyed this episode, please share it with others and post it on your social media platforms. You can subscribe to our podcasts on Apple Podcasts, Spotify, or your preferred podcast directory. For more information on our topic, please visit CMTC is a private nonprofit organization that provides technical assistance, workforce development, and consulting services to small and medium-sized manufacturers throughout the state of California. CMTC’s mission is to serve as a trusted adviser providing solutions that increase the productivity and competitiveness of California’s manufacturers. CMTC operates under a cooperative agreement for the state of California with the Hollings Manufacturing Extension Partnership Program, MEP, at the National Institute of Standards and Technology within the Department of Commerce. For more information about CMTC, please visit For more information about the MEP National Network or to find your local MEP center, visit

Topics: Food and Beverage, Quality

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