Pitfalls of Accounting for Intentional Adulteration in Your Food Safety Plan

Pitfalls of Accounting for Intentional Adulteration in Your Food Safety Plan



hello welcome my name's Simon simply from the international food safety and quality Network welcome to ignition 95 of the food safety Fridays a webinar program today we're going to be talking about the pitfalls of accounting for intentional adulteration in your food safety plan with an ill Arnold from AIB international but before we meet oh just a couple of things I've loaded in the sidebar a attendee webinar checklist please have a look at that file if you are having problems it gives you the best practice and things to do so that you can watch and listen to this webinar and get the best out of it so please do download that file and have a look also obviously a lot of you regulars are already commenting in the sidebar saying good morning hello from wherever you are you are welcome yet just type your comments get to know each other and type your questions we'll highlight those and we'll pick those up at the end of the webinar so welcome everybody nice to have you with us and Earl are you are you with us I hope you are hi microphone microphone here we go yeah al are you doing good how are you doing today sir Eamonn fantastic fantastic where you calling him from well I am calling in from a bombing Austin Texas Austin Texas and I'm calling him from actually it's quite quite warm and sunny in Manchester England as well so yeah lovely we're both basking in sunshine okay if you'd like to get your slides ready Earl I'll just tell the audience about next week's upcoming webinar and then we'll get get going okay right you'll seen the sidebar a picture of George Howlett from safe food 360 and the webinar is understanding the link between hazard risk and control so that's next Friday at 3:00 p.m. before I move on I'm just going to thank the sponsors of the food safety Fridays webinars or else none of us would be here they are safe food 360 trace analytics Mettler Toledo DNV GL and AIB international and on that note I'll leave it to Earl from AIB international I'll be back later excellent all right well good morning everybody so today we're gonna be discussing the pitfalls of combining the food safety plans and food defense plans together at first glance this seems like it might be a great idea however we're gonna discuss during this presentation the reasons why you might not want to do this during this training we're going to discuss the pitfalls of combining the food safety and food defense plans we'll discuss the general requirements for the food safety plan and the food safety plan and we'll cover some of the similarities and differences that these plans contain we'll also cover the differences in methodologies used to complete either the hazard analysis or the vulnerability assessment so that we understand our responsibilities and requirements next we're going to discuss the records requirements for both plans and last we'll look at the reasons why we might not want to combine these two programs together so here is our first question that we want to find out a few guys know so from your current understanding what are some of the similarities between the food safety and food defense plans that we have to put together whether we're talking about the FDA requirements or the GFSI requirements okay ladies and gents you know how to type in this sidebar yes so what do you think some of the similarities between the food safety and food defense plans might be a little tested knowledge to make sure you're you're awake so yeah do type in if anybody is having a problem remember look at the checklist and then follow the best practice in there and that you shouldn't have any problems okay Pauline we have to conduct a risk analysis Brown brandy searching for risks and how to address them perimeter security Fran both must be documented and must include a risk analysis Brooke plants access GM food safety own intestine intentional adulteration Ernest conducting hazard analysis of meal identify how an employee may adulterate a product Cheri risk assessment alaria both risk-based to be documented required by FDA require how does hazard analysis Andromeda's proactivity vs. planning prevention so from so all of those are some really good examples and and your guys are right for the most part here is some similarities so like you guys were saying both do you require some sort of an assessment for the food safety plan we call it a hazard analysis for food defense we call it a vulnerability assessment both of them require some preventative measures for those significant issues we identified during those risk assessments or hazard analysis so for the food safety plan we kind of call those preventative controls or critical control points underneath the house of requirements and then for the food defense plan we call those mitigation strategies both plans require these things to be conducted by trained and qualified personnel both are supported by prerequisite programs like somebody mentioned secured parameter so that's a good prerequisite program for food defense and you know say washing hands after we go on break is a good prerequisite for the food safety plans now both also require if we identify significant risks to monitor them to develop corrective actions and to conduct verification activities so seems like we have a really smart class here today Simon always always so now we're gonna go with an overview of the food safety plan so as you can see on the screen the food safety plan is 21 CFR 117 that's the FDA's regulatory requirement the title is good current good manufacturing practices and hazard analysis and risk based preventive controls for human food with some exceptions this rule applies to both domestic and foreign companies that are required to register with the FDA and then on that next slide we're going to look at some of the exemptions so the people that don't have to comply with this so it's also important to note that this part of the regulation also covers new GMP s so in the past the regulatory GMP s were in 21 CFR 110 but when your compliance date hit you're not required to follow the ones that are found in subpart B of this regulation and there have been some enhancements from the old to the new now compliance dates for when you had to be ready for this rule is for very small businesses you've had three years to comply with this regulation which means that September of this year you need to be ready for being in compliant with this regulation for small businesses you had two years to comply and you needed to be compliant last year and then for the larger companies you had to be in compliance one year after the rule was written now exemptions if you were a facility that that's supposed to fall underneath USDA regulated products then you do not have to follow the preventive controls rule requirements if you're considered a qualified facility which means basically that you met that requirement for a very small business which is basically you don't make more than 1 million dollars annually for three years consecutively in a row and that includes all products you still have in stock plus what you sold if you meet that requirements then you only have to follow a very limited amount of what this regular requires if you're required to fall underneath regulated fish or fishery products then you're gonna follow that if you're required to follow half sup either juice or seafood then you don't have to comply with this regulation if you are following the low acid canned foods regulation then you don't have to do the full-blown procedures in here you would not have to account for micro but microbial hazards but you would still need to focus on the physical chemical radiological and economically motivated adulteration if you produce or hold on to dietary supplements you will follow that regulation and not this one and then if you're considered a farm and if you produce alcoholic beverages in most cases you won't have to follow this rule and if you hold fully enclosed foods that are not exposed to the environment then you'll have to follow the modified requirements if you maintain temperature for food safety if you don't then you're exempt from the rule altogether now a little bit of what the regulation covers which is these following sub parts subpart a really focuses on just basics of the regulation it gives you who's who's applicable to this regulation it gives you a list of definitions and what those meanings are it talks about qualifications of individuals and it also has in there who needs to comply with the regulations and what are the exemptions subpart B is the new GMP requirements that I mentioned earlier so it's got some updates basically one of the major ones is that it brings in cross-contamination as a new term or across contact as a new term meaning that allergens accidentally being introduced into the supply system subpart C talks about everything you need to do for the hazard analysis subpart D is those modified requirements I mentioned so if I'm considered a very small business I would follow these or also if I'm a warehouse and all I do is hold fully-enclosed products but I do have temperature control for safety then I would follow the modified requirements in here subpart II talks about if I do bad things what's going to happen to me meaning that I'd lose my qualified status subpart F covers all the records requirements for this rule so what I have to do and how the records need to look and then the last part is this is the supply chain program so I need to ensure that if I have any anything important dealing with food safety that my supplier is going to control I need to include that within my food safety program now in overview like I mentioned you need to have your updated GMP s and you want to make sure that if you haven't take a good look at these new changes within the program which is basically like I mentioned they added in the new term allergen cross contact the significance of this is it is mentioned over 24 times within the new GMP requirements so you really want to make sure that you're focusing on how you control allergens within your facility the other things that we're included was they changed a terminology like the word using must – shall and then they also did include in their requirements that you might need to clean non-food contact surfaces more often to prevent that potential allergen issue they also had other requirements in there what the hazard analysis had and how what the hazard analysis looks like it is similar to a hasip analysis that we've been doing probably since the 60s in the food industry which basically requires you to look at the following contaminants chemical biological radiological and physical the last one that we need to include in this program is also economically motivated adulteration from the FDA's requirements which basically means food fraud that could lead to a food safety issue such as melamine and milk products or peanut residue in cumin that was added in there on purpose to help increase the yield it also requires us that if we when we did our hazard analysis if we had significant hazards then we needed to implement preventative controls the possible preventive controls that we can implement our process preventive controls allergen preventative controls sanitation preventative controls and supply chain preventive controls and the last one is any others that we see fit could be maybe a maintenance preventive control or something like that if we have a preventive control then we need to develop management components that shows that we are controlling it and this is going to be the monitoring the corrective actions and the verification activities for food safety if we have preventative controls then we must have a documented recall plan and then of course have all the records that are going to support what we do in our food safety plan so pretty pretty cut-and-dry I know most of you already know this information now we're going to switch over to the requirements and the food defense plan so the official regulation name for food defense is 21 CFR 121 which is mitigation strategies to protect food from against intentional adulteration and this regulation was published on May 27 2000 2016 and it comes effective for those very large facilities next year so May of 2018 or I'm sorry 2019 this rule or regulation only focuses on intentional adulteration whereas the food safety regulation focuses on accidental contamination or adulteration now one thing the caps are here to is the definitions of a small business very small business and other than small and very small are a little bit different so FDA's definition of a very small business is generating annually 10 million under 10 million dollars for a three consecutive years to include product we may still have in Dok instead of the $1,000,000 so there is a slight difference the definition of small business is the same which is basically having under five hundred full-time employees now the exemptions for the food defense plan you're gonna see are also similar to the food safety plan if I follow USDA regulated products then I fall underneath that regulation if I'm a considered a very small business I'm on relatively exempt from the regulation I'm considered a qualified facility and so I only have to let FDA know that hey I am having I do have a vulnerability assessment I am following some format but I don't necessarily have to have the full-blown program that we're going to cover in a minute if all I do am a business that holds food and that food is fully enclosed and it's not exposed to the environment I don't necessarily have to have a regulated food defense program the only difference is is if I am holding on to balck liquids now FDA's perspective of bulk liquids is not barrels totes or buckets it's large tanks with huge amounts of liquid if I am a facility that packages repackages and I'm exposing that primary product to the environment then I need to follow the rule but if I'm not if all I'm doing is taking different flavored waters from individual packages and combining it like into a multi pack and I'm not exposing the product to the environment then I'm exempt from having this regulated food defense program additionally if I'm a farm then I follow the produce safety rule requirements if I'm in beverage facility then I'm gonna follow those requirements underneath the state treasury or or other applicable regulations additionally if I'm a facility that produces animal food or animal feed I'm exempted from this regulation and last but not least on farm manufacturing shuts as eggs and game meats and those kind of things those types of facilities are exempted from the rule as well now the regulation breakdown for the food is basically subpart a again similar to the food safety plan where it has who needs to comply with the regulation the definitions that are covered within the regulations so we understand what those terms are and it also includes exemptions from the rule subpart B is totally blank right now they do have it there but they're holding it in case they need to add something new into the future subpart C talks about all the requirements for the vulnerability assessment and what we need to do for this regulation subpart D talks about the records requirements and subpart E talks about compliance and fair with compliance now here is our next poll question so and we're kind of focusing on the food defense requirements but what is meant by a significant vulnerability so what do you guys think yep yep what is a significant vulnerability also seen an egg pasteurization facility is xn of exempt to the rule right right anyone sorry it broke any vulnerability that could result in harm to VIN humor that's not bad star risk likely to occur adulterated kodox outdoor silos smth under a greater risk for food products milk powder coming from China a high risk high opportunity no food safety plan slip in the process that if exploit C could reasonably expected to cause White's Gail public harm are just money it's just my word not implemented huset plump properly one which could cause widespread harm I think I probably well the audience yeah they'd mentioned it they've captured it I think I'm there absolutely they have so the death finishing out of the regulation is a vulnerability if exploited could cause wide scale public health harm now keeping that in mind you can also even use this and say what is a significant hazard because you're looking for that and a food safety plan and it's basically the same thing really what you're doing is looking for that issue or that problem whether you're looking at food safety or food defense for where in my processing step could a significant hazard happen that could lead to a class one recall or people getting sick or hurt or dying and that's both for food defense or food safety so great answer guys now the overview of the food defense plan says that I need to conduct a vulnerability assessment if I have a vulnerability assessment and identify a significant vulnerability then I'm required to develop mitigation strategies and if I have mitigation strategies then I have to develop those management components which are called food defense monitoring food defense corrective actions and food defense verification I'm then required to have records to support my whole entire program so as you can see it's a little bit at least up on the screen appears just a little bit less than what the food safety plan is requiring so now what I want to discuss is the similarities between the two requirements now I know initially I was talking about the regulatory requirements however all of you are very familiar and probably follow some sort of GFSI scheme as well so whether it's be our CFS SCS QF or others most of you are aware that those new changes that have been added in and I'll give an example of FSS C's version 4.1 that asks facilities to develop a food defense threat assessment the requirements of what they're asking for and what the FDA regulation ask is asking for are very similar as well not identical but the the requirements that they're looking for are pretty similar in fact those of you that are following the FSS a FSS C scheme might have seen a couple of weeks ago those guidance documents that they brought out that actually even references being able to use the FDA's food defense plan builder to help you cover those requirements so even though we're kind of discussing FDA requirements here this does fit if you're following a GFSI scheme and maybe don't even have to follow the FDA requirements now similarities so in both plans the training requirements are similar you basically need to have those four levels of training for either the food safety or food defense however the training is a little bit different but in food safety and food defense we need to have that top trained individual whether you're considered a preventative controls qualified individual or an individual that can conduct or oversee the development of the vulnerability assessment so that's your top tier level of training someone has to be qualified to conduct that hazard analysis or vulnerability assessment the next level of training that you're going to want to have is the training for your supervisors and managers more than likely in your facilities these individuals are going to be the ones that are going to be doing your corrective actions your verification activities and might have oversight of more than just one preventive control or mitigation strategy so their training will need to be a little bit more than your associates or your full-time employees but not as extensive as that preventive control qualified individual or the one that's doing the vulnerability assessment the next level of training is that person doing that job so if you have a preventative control say conducting a metal detector then that person needs to be specifically trained on how to do that task and what to do if there's a failure and that could be as simple as I got a call a manager same thing for a mitigation strategy if I've identified a deviation in that plan or if I'm doing that task like say checking seals on any bulk liquid tanker so that I can ensure that contamination or adulteration did not occur during transport then I need to be trained on that task and what I'm supposed to do the last level of training that we need to cover is everyone in the facility has to be in general food safety awareness as well as general food defense awareness training so the requirements for training are very similar between both plans the assessment is similar meaning that we have to complete an assessment whether we're doing food safety or food defense so we have to do a hazard analysis and and look at likelihood and severity for those contaminants and food defense requires you do the same thing like I mentioned earlier if we have a significant hazard or a significant vulnerability then we need to develop mitigation strategies or preventative controls in this part similar to we got to develop our preventative measures and these are going to look different from facility to facility because they're supposed to be facility specific if we have those preventative measures then we have to have those monitoring corrective actions and and verification activities and the requirements are similar but there are some differences that we'll talk in the next slide in general record's requirements are almost identical between the two plans but there are a key a major key difference that we'll talk about on the next slide both plans have to be reviewed on a certain specified frequency from the FDA standpoint at a minimum you have to review both plans every three years in their entirety there are some ORS meaning that there might be conditions where you need to review it more frequently than that but it stipulated that at a minimum it has to be every three years additionally once we complete our food safety or food defense plans they're required to be signed by this senior most person in that facility once we complete it and anytime there's a change so this requirement between both write-up plans are the same at last we're going to have those prerequisite programs that support our food safety and food defense so and even in some cases the same prerequisite programs will support both programs for instance we'll talk about our hand-washing procedure and washing after coming back from a break or going and and utilizing the restroom are both important for food safety and food defense from a food safety side it's just oh I might have accidentally contaminated my hands so why don't my own Oh make sure I wash them in the proper manner before I go back and you know act and start touching product or whatever from a food defense perspective it's also a good idea because of the fact that if I don't wash my hands and I'm the kind of person that's looking to try to do something bad I could use something so so easy as intentionally contaminating in my hands with whatever it could be a microbe of some sort or even just you know allergens like say maybe I had peanut butter for lunch and I put it all over my hands don't wash it and now I'm gonna go touch product and that allergen might be able to intentionally transfer to a product somewhere so that's just an example of how I pre work as a program can support both programs now the differences in these are kinda really drastic so the first one is the assessment on the assessment for the food safety plan it's pretty basic meaning we just have to look at those contaminants and then when we're going through our processing steps look at likelihood and severity if that issue may or may not occur that's all we're required to do and most of the time the hazard analysis that we conduct is a house of style hazard analysis and there's no different options to choose from to do that the management components are also completely different the food safety plan calls out those four or five potential preventative controls and there are some prescriptive requirements if we have them for instance if we have a process preventative control like say the metal detector or even say temperature requirements like we're going to ensure that a product gets to a certain temperature we also have to validate those preventive controls meaning we have to pull out that scientific information that really shows that if I do get it to that temperature it will kill that fact that that microbe that I'm worried about or my mom my metal detector really will scientifically detect those sizes that I'm worried about that could lead to food safety for food defense there's no requirements for validating anything yes verification has to occur but validation does not records are going to be very similar but there are some major differences the major key one is food safety for those of you that may or may not be aware if you if you have to show them to the FDA any records that they take out of your facility are potentially available to the public due to the public disclosure laws so in all honesty in some cases I can write up to the FDA and say hey can I see the food safety records you've gathered for XYZ facility and if they have them they might have to share them food defense is going to be totally different the FDA recognizes that you're developing this plan and these mitigation strategies you may have employed is how you're trying to stop a bad person from doing something bad on purpose so these records in the food defense plan are not going to be shared with the public they will not be part of the public disclosure laws how do you review the plan there are a few differences so the minimum is the same however there's one major difference between the two one of the ORS meaning the other time you might need to review your food defense plan is if FDA tells you to now this one's a pretty big one because people really don't understand what this means FDA has a lot of great contacts and there have a close relationship with the security agencies in the United States so if for instance the FBI or Homeland Security would receive a credible threat on say an ingredient being contaminated or a facility being targeted they would actually reach out to that facility or facilities that are dealing with those things and give you that information sup saying hey you might want to look at your food defense plan because here's all the information we have you may be a target or the ingredient you're handling as a target so if you do get that call it's very important that you do take a look at your plan again and make sure that it's as tight as it can be now for the recall plan the only one of the programs that requires to have a recall plan is the food safety one so food defense does not stipulate that if you have a mitigation strategy you have to have a recall plan the major difference between the two is the methodology and the thought process behind conducting the assessments food safety is accidental and we've been doing this since the beginning of food safety regulations and the following of the GFSI schemes this is in our blood this is what we do every day we look for those accidental contamination issues intentional adulteration in the context that the FDA and the new GFSI regulations are asking for is drastically different in the past we used to utilize things like oh I got a perimeter fence I have cameras on the outside my doors are locked so bad people can't get in and I'm really good the requirements for food defense now or at least the regulatory ones coming up or the GFSI ones is drastically different you need to look at your processing steps and determine how can someone do something bad so where is product exposed to the environment what can I do to reach out and touch it and add something bad and do it where you won't catch me this is a total different thought process from from accidental that if you maybe add it in to the food safety plant you're gonna miss that if you have the same groups of people doing both assessments you might miss that concept and last but not least prerequisite programs so I kind of gave an idea on the similarities of where there are going to be some prerequisite programs that that will support both food defense and food safety whether there are going to be prerequisite programs that are gonna be totally different that maybe right now you don't think think of them in that way for instance as I go and develop my food defense plan I might utilize locks or locked doors as a potential mitigation strategy so that somebody nobody can get into a room unless you know they're authorized to however my that mitigation strategy will only be as good as my key control program is so I'm gonna have to have a well-developed prerequisite program and how I control keys and my facility to limit access to them for instance if I have five keys to my chemical just Orage room and I'm only issuing them out to five people I should have good documents that shows that I've issued them out to these five people that they're acknowledging that they got them and I periodically inventory to make sure they have those same five keys and haven't made copies of them if we don't control keys good in our facility then we don't really have a good mitigation strategy so an example of how there are going to be different prerequisite programs that we either may have to develop or review that's going to be different than we would normally have in our food safety programs now when it comes to methodologies like I mentioned when we're doing the food safety plan hazard analysis there's basically only one and that's the hasip style of an assessment when it comes to food defense there is a list of potential methodologies we can use unless long as we capture the basic requirements so for food safety we can do the house of style we just need to consider those contaminants which is biological chemical physical radiological and economically motivated adulteration we identify those hazards and assess just the likelihood and severity if that event would occur and we're looking at is control required so if we have a significant hazard that then we need to go ahead and implement some kind of control based on that risk rating that we gave it during our assessment pretty cut-and-dry because we've been doing this for very long time the FDA even helped us out because they created a food safety plan builder software system that you can download and use standalone and it captures all those requirements and if you haven't had a chance to look at that you might want to consider it because it's really good it's actually I'm so surprised that a government agency came out with a very good program it always doesn't happen that way for food defense as you can see on my little pun on the slide it's the wild wild west there's no true defined methodology in fact the FDA says you just need to use an approved methodology and they give you some examples but they're not cut and dry so one that gets mentioned a lot is Harbor plus shock and we're going to talk about this individually in the next few slides these actual methodologies another one is operational risk management and yes it's it's mentioned in the preamble of the regulation for food defense but we can use a half SEP or harp C style assessment and we can also use the key activity types as part of our assessment and there's many more the Carver plus shock the goal is to identify critical nodes that are the most likely targets for intentional adulteration Carver plus shock results in targeting conclusions that are consistent with those high risk vulnerabilities and in augments the or it augments because processes are allows identification of either economic or psychological impact through that shock factor now Carver plus shock is an acronym and it fits these following seven attributes so when you're doing the assessment using Carver plus shock it hits these seven nodes so it covers criticality it covers accessibility it covers recuperate ease so how fast can you recover after an event and not just focused on the facility but also on the individuals health that might have been affected it covers the vulnerability of that critical node what would be the fact if that event occurred and then the recognized ability of the company or that processing step and last the shock factor which covers in that financial or backlash maybe on your brand if there's if there would be an issue now originally Carver plush shock was developed by the military and utilized for those types of events so that it could capture you know before they did something what would occur but the regulator's in food safety have have kind of hijacked this assessment because it's really detailed and factors into food safety parameters in fact before USDA developed these regulatory requirements they conducted several hundred vulnerability assessments using this Carver plus shock system on farm-to-fork ingredients and facilities and that's how they came across the requirements of the regulation and also the key activity types that we're going to talk about and then in a few slides from now another approved methodology is the operational risk management system it's a six step sequence that allows you to increase operational effectiveness by looking at in anticipating hazards and reducing a potential for loss the purpose is to minimize risks to acceptable levels and and being able to do this proportional to whatever your accomplishments are as you can see in the next slide here are the six actual steps so step one is you need to identify the hazard so an example could be I'm going to look at how could contamination occur at my bulk liquid tanker receiving process step two is I'm going to assess the risks so I'm going to rate the risk for the three required elements so food defense is prospective from the regulatory standpoint where it says I need to assess these three things the ability to contaminate so how likely can someone do it like is it located in an isolated area or are there nearby chemicals or contaminants that could be used intentionally with an easy grasp the second element is the accessibility of the products so you're looking at how can I can I reach out and touch product so do I have a tank and is the lid locked and secured or is it just wide open to the environment and the third one is public health impact so if I added a contaminant at this processing step what would be the impact what a lot of people get sick what a lot of product be affected those kind of things so when you're for step two when you're assessing the risk you would just need to demonstrate how you looked at those three elements but you can analyze potential control measures like placing on seals or conducting inspections or even doing testing and then step four is you're going to make those control decisions so you might come up with three or four potential mitigation strategies but in step four you're going to actually pick the best one that fits for your facility Step five is you're going to implement those controls and then step six is you're going to supervise and change as needed based upon your findings this is an example of a hasip style assessment that covers the requirements of the vulnerability assessment as the FDA dictates it so as you can see on the left-hand side of this you have your contaminants listed so biological chemical physical radiological because that's what you're required to evaluate during food defense you can see there that I have a place to rate based on likelihood and severity the degree of physical access to a product the ability to contaminate and the public health impact and a place where I can give my overall vulnerability ranking and is it an action of a process step or have I identified as significant vulnerabilities so just another type of a methodology that could be utilized the next one oh that I I guess I don't have a slide for so I'll cover it really quickly the FDA like I mentioned did those vulnerability assessments hundreds of them when they did those they always came out with four key processing steps that were always considered high-risk those included bulk liquid receiving and unloading bulk liquid storage secondary ingredient handling and mixing and blending activities so FDA says that you could take those for processing steps and utilizing your flow diagram you have for your facility compare these four key steps to what you have in your flow diagram and if you have similar activities then those would be considered your significant vulnerabilities where you had needed to implement controls now in my personal opinion I think this type of methodology could be misleading and might make us miss some things that we normally might not have observed during an assessment but it is an authorized methodology of conducting a vulnerability assessment now the pitfalls what are the dangers of combining both of these plan so if we do and include both together as we've seen yes there are some similarities but there are some major differences too as well so although the food safety and food plane requirements are similar there are major differences when combining plans you very well could miss some of the requirements for one or both plans such as capturing the three specific elements in the food defense plan assessment public health impact accessibility and ability to contaminate or not capturing economically motivated adulteration in the food safety plan as well as the differences in the verification requirements such as for food safety you need to verify all documents within seven working days and in food defense you just need to verify documents on your own define frequency that you've put into your plan those are just a few examples of the different requirements now as we discuss the training aspect is similar however the methodologies used you conduct these assessments is vastly different APC Qi leading the food safety team would focus on food safety which probably comes natural however the qualified individual conduct to conduct or oversee the development of the vulnerability assessment well think differently and this will take training and education to think like a criminal and think intentional versus accidental combining the plan could potentially allow you to miss hazards or vulnerabilities like I mentioned earlier your food defense plan will state how you will prevent intentional adulteration so sharing this plan with those that do not need to see it couldn't put you at risk if you combine your plans and a third party auditor or customer will now have access to those vulnerabilities and mitigation strategies you have implemented to reduce the potential that intentional adulteration would occur for food safety we want everyone to know how we're going to control accidental food safety hazards for food defense we don't want people to know how they can contaminate our product remember those public disclosure laws I mentioned earlier if you combine both plans these documents and/or records may not be able to be separated now leaving it possible for the public to aim to obtain these elements of your food defense plan and increasing your risk of intentional adulteration at the facility as an auditor and food safety professional I can see the attraction of combining both plans our time and resources are very limited many of the members to assist the development of the food defense and food safe plant might even be same members however as an auditor and food defense expert I see the pitfalls of combining them in my opinion having them remaining two distinct separate plans will protect your company and allow you to ensure that the requirements of both plans are met so in summary during this presentation we discussed the requirements of 21 CFR 117 the current good manufacturing practice hazard analysis and risk based preventive controls for human food and we discussed 21 CFR 121 mitigation strategies to protect food against intentional adulteration regulation we discussed the similarities and differences between both plans we also discussed the methodologies used to conduct the assessments in both plans and last we discussed why it might be a hazard or the pitfalls of combining them together here in a moment Simon's going to start opening up the floor for questions so we will do those questions then but I just want to add in just a couple of things for those of you that might or might not be aware here at AIB we have a course called the for the food defense coordinator online it's a new program it's focused on the regulatory requirements for the FDA and it may be important for you to do so that you can be understand the requirements of conducting the vulnerability assessment another potential product that we have is we can help you by conducting gap assessments or vulnerability assessments at your facilities so we can come to your facility we can review your plan we can walk your facility and coach educate and teach on potential gaps you have and where you might want to adjust anything some other things that we have is we have what's called the FDA preparedness inspection where we can come into your facility and we act as the FDA to test your facility to see are you ready for FDA's new type of inspections some of you on here may have already gone through a recent FDA inspection understand what I'm talking about that it's totally new where they used to stay in your facility one day now they're staying five days a lot of our customers that have gone through this type of inspection already they're nicknaming it an FDA preventative control inspection so anyways these are the some of the products that we have that can insist and there's many many more but I'm not gonna I'm not a Salesman so I'm not going to go through them all but I do want to say thank you here at AIB we really do enjoy working with all of our customers and hopefully new customers on food safety and food defense requirements and if you're interested and you have any questions please reach out to the link attached to this slide which is info at AIB Online org or you can call our number at eight hundred six three three five one three seven if you have any questions either related to food defense or food safety okay thanks for that oh you can stop first sharing now and that's rich web come on and there have been a lot of comments and questions throughout but some some of the members actually we're answering the questions and providing links and also I have no idea where we're up to so we'll start again so let's see Ernest just was providing the recording and slides afterwards by email and Scott has mentioned it's a bit of a challenge I don't know it's quite a long one to me this didn't clarify anything how and who you are preventing against is it a Breaking Bad PhD person who knows the whole system or a barely literate person is it a person that knows how to get microbes or a person that doesn't seem to know how to wash their hands so Scott that's a really good question now from GFSI and food defense here this what you're looking for is similar you're really trying to focus within your processing step where someone can reach out and touch product it doesn't matter how much knowledge they have or how little knowledge they have but the both both requirements are you have to consider that these things can be done by somebody inside of your facility such as like a disgruntled employee or maybe even a contract so these individuals that might be in your facility might have a little bit more knowledge than say Joe walking off the street and being able to get inside your door and go do something so yeah we need to look at that potential that that person might have a lot of knowledge or a little bit but in general your food defense program is going to be based on how can I limit access if I've observed a significant vulnerability I'll give an example at bulk liquid receiving the biggest hazard that that's been identified is when we get that truck driver in our bulk liquid area and we open up the top of that tanker so that we can allow venting during the unloading process now that product is accessible if someone's not watching the top of that tanker during the whole time the unloading is happening or if it isn't a fully secured building and the drivers left their uh nilin or unattended now that driver has an opportunity to when we're not around climb up to the top of that opening and add a contaminant in so that's kind of like the perspective that you're looking at and I hope that kinda explains a little bit better what were what we're talking about okay thanks so yet one from these kind of food safety defense plumby can bind with the food fraud plan so it can but truth in reality I would consider putting the food fraud plan with my food safety plan from the FDA standpoint when you're looking at food fraud that could lead to a food safety issue you're already required to combine it in the food safety plan now I do know that GFSI requirements for your food fraud assessment is totally different it's wide-ranging it's not just food safety elements but it's things such as are you sure that that ground beef isn't horse meat or are you ensuring that that honey you're getting in is not just pure honey but could it be combined with corn syrup to thicken it up and fraud somebody so the requirements are different but again this is how someone's trying to do something intentional yes but the point is I'm just trying to make money usually the intent is not to hurt anybody they just want to make that profit and you not know that they've actually done the fraud event so in my personal opinion I would consider not putting it with food defense but I would put it with my food safety plan okay thanks earnest Rai be developing a food fraud vulnerability core so have you got no actually that's a good question we are working on that development now so we are almost through with our development phase we still have to go through the test phase so stay tuned now a little birdie told me that we're looking at possibly holding our first course and maybe as early as October don't hold me to that but I think that's the Birdy's goal I don't know where it's gonna be held out but it's going to be a public event so stay tuned and sign up for it when it comes out okay great and it's just another question will AIB make the food defense coordinator certification course in a printed format I'm not sure what's meant by that I know we have the online course where you can do it individually and then we also offer this as a public course or even a private course so we can come to your facility and just be facilities specific now when you are a participant for our public or private course you have the option of getting the printed materials because we do offer the printed participants guide and the handouts and stuff or getting these materials electronically so now you already have them on your computers so I hope that's what you meant Ernest okay irena what are the possible emergency steps in the food industry for a case when all staff have food poisoning it's slightly off topic a thing but can you answer help with that so I might be able to so now this is something that I have noticed I've been consulting with the industry and helping out and I know some facilities have those cafeterias or cantinas that are located within where your employees have the ability to purchase lunch there so I'm gonna use that as a potential scenario even though this portion is not required to be covered underneath FDA because FDA is worried about customer not retail however it could be a risk if your kitchen staff that's making that food for your for your employees to purchase they could intentionally adulterate so you want to look at that potential if there is a potential for that maybe you now require that contractor or whoever's running your kitchen to develop a plan themselves and you guys review it to help minimize that potential impact so I hope you also might want to consider when you're doing massive office events like barbecues or dinners that may be scrutinizing your vendors you're getting that from and how they move that product from their facility to wherever you're having the event to minimize the potential of mass food poisoning and such like that okay thanks so Kristoff is asking how our Freight is affected by the food defense plan are they responsible for their own activities or will the companies be the only accountable as for transport so that's a good question so most of you might be aware that in the States there is a sanitary transport act under FISMA which basically does hold the transportation or freighters with some responsibility when it comes to food safety however the responsibility is defined by the entity that's required to ship the product so if I am a maker of widgets and I'm gonna ship those widgets out I need to tell that freighter company what they need to do to keep my product safe and then they're required to develop processes and procedures and conduct training for their employees food defense is kind of not underneath that so when you're doing your own food defense plans it's only when that product touches your door where you start receiving your ingredients until it goes out your door but in most cases when you're making products such as say you know canned goods or something like that it's leaving your facility triply protected so you got a box and then you got a can and then you might have individual packages so the likelihood of intentional and alteration occurring that's going to cause that wide scale type potential is almost non-existent because that person receiving that product if they see the package is damaged they're probably not going to accept it so that's kind of by the FDA didn't make it a requirement to for freighters to kind of control anything okay very good John jump to the AIB food defense coordinator class in 2002 Oh 16 years ago Wow is it the same or is there a change and there are major changes from that program so what you took back in 2002 was current industry requirements best practices now our our course is for really focused on meaning FDA requirements however like I mentioned earlier even though we focus at the FDI it also will help you meet those GFSI requirements because they are really similar now if you're current and you're looking at recertifying every year we produce to our webinars that have the newest updated information so for instance if your recertifying this year you can go and watch two webinars one is a one-hour webinar on basically a condensed version of the requirements of the new regulation of what we need to do and the second webinar is some prerequisite programs that might be important for food defense and how to develop those so I hope that answers your question that the new online course is not the same but but we do have a way to capture if you become a sort of a certified individual that when you recertify you can get that new information and stay up to date right brilliant rocki rocki is asking about the fee structure but I guess there's a variety of course is it better off looking at the AIB website I guess for pricing absolutely or if you really have some specific information just send that question to info at AIB Online org and our and our individuals that the office will send you all the information you could ever ask for and it'll be pretty quickly – okay great and SG you know sometimes the auditors are aware of the possible hazards in the facility even though the company is SF SF hasip certified I'm just wondering that why auditors neglect this hazards on what basis do they pass the orders okay so I can only speak on what we do at AIB and I'm going to focus on our GMP audits that we do so when we do an audit and we review your plan your your hazard analysis or your hasit plan we're not judging it we're just looking to see are you meeting the requirements so did you assess all of those hazards that you're required to how did you include EMA in your assessment how did you include looking at radiological hazards and if you identified significant hazards did you develop preventative controls and then of course we would review are you following them the beauty about the requirements of the FDA is is that there's nothing regulated so you might have identified a food safety hazard or say a food defense hazard but the FDA does not say if you have this hazard you have to do this a facility can choose many different ways to control it so when we review food safety plans or food defense plants we're just seeing does it make sense and then whatever you wrote down are you following it we don't judge um whether you're wrong or right on how you assess the plan that we might educate or we might say you might want to consider but we would never score anything unless you're really missing the requirements of the regulation okay so thanks for the clarification Vivian how to keep the food defense blank confidential if it's been audited by GFSI are requested by a customer earlier in your presentation you mentioned food safety plan is available versus food defense not available to the public so what you thought this is good so a lot of you in the past always have been doing really good and having a basic vulnerability assessment that doesn't show a lot of things I've seen some facilities have a checklist I've seen some facilities that have a rough statement that says we've done this we've captured this and we've done this I would initially try to share that with a GFSI auditor I would also reach out to your scheme owner what other it's sqf or BRC and just ask let them know your concerns and find out what you can show them to show that you're meeting those requirements but not sharing those secrets that's important to your facility that's what I would recommend okay stacy has just said also we have customers request our food defense plan yeah okay Laura Lori in another webinar I attended it was mentioned that the current food defense plan build that did not meet the requirements required for a food defense plan under FISMA is this also AI be his opinion so it's not even AI B's opinion but I do agree with that FDA has stated it on numerous occasions the current food defense plan builder does not meet the regulatory requirements of their role now they are working diligently to update it to meet those requirements if you are out there and you are using the current food defense plan builder just make sure that you meet all the requirements however they say that when they get the updated version which I know is going to be up soon before the compliance date hits for the big ones the information you already have in it is supposed to be able to automatically transfer over to the newer one so you didn't waste your time if you're using the old one but currently right now it doesn't meet regulatory requirements however it may meet GFSI current requirements so especially from FSS ii standpoint they even say that is a good vulnerable or Vanar ability assessment you can use to cover the requirements so again regulatory know the current one doesn't mean but GFSI it might okay irena in case a step had a high risk eg water storage in the food defense plan after the review considering historical data can it become a middle or low risk if nothing happened so yeah you bring up a great great a great concept so when I'm evaluating a processing step say like a bulk liquid storage tank just remember though yes historically you are looking at has water ever been you know intentionally adulterated before and those kind of things but when you're reviewing a processing step you need to keep in mind that if you do have control say like you already have a lock at the top of the tank when you're doing the assessment you need to pretend that that measure is not there because more than likely that measure will become your mitigation strategy you'll just have to formalize it more often now what I encourage facilities to do is re-evaluate where they use locks if I have a storage tank and say the top of my hatch is locked but I rarely get into it something you might want to consider doing is having maintenance come along and bolt it down we can still get in it when we need to so we can use a special tool to open it up but now in general it's not accessible so now the risk rating can be dropped lower because now I don't need a lock and it's not going to be a mitigation strategy because it's just not accessible make sense yeah okay okay at least does the FDA have a list of the gaps posted somewhere okay so this is also a good question they really don't have a list of gaps but they do have a very useful tool that can help you when you're looking at mitigation strategies they have what's called the FDA mitigation strategies database so when you're doing your assessment if you find a vulnerability but you can't figure out how what you can do to reduce the potential you can go on this website and this database and you can type in a processing step say bulk liquid unloading and you can hit enter and you're gonna see like for for bulk liquid unloading about six or seven pages of options of potential mitigation strategies you could use now these are only recommendations they're not requirements so it isn't that you have to use these but what I always encourage facilities is if you're struggling look at it you might be able to see a couple of things that get your brain going oh that makes sense I didn't even think that that could be a mitigation strategy so I can take this piece here and this one combined it and this will work and I can show that it's going to reduce the potential so I hope that helps yeah I'm sure it does all right on that note we'll call it a day I think we've picked through all the questions if there are any further questions just send them over and Earl said that they will follow up with those if we've missed any great thanks very much for your time today for the presentation and also for answering the attendees questions it's great to have you and I hope you'll be back on another webinar very soon Thank You Simon as always it's always a pleasure to work with IFS QN and I I look forward to any opportunity brilliant all right have a nice weekend Earl and I'll see you soon hopefully thank you have a nice weekend everyone cheers bye ladies and gents that was Earl Arnold from AIB international will issue the slides and the recording afterwards the slides will include all the contact details so if you have any questions about any of those courses mentioned training courses just get in touch with them I've already loaded this certificate in the sidebar so you should be able to download that it's Friday yes bye bye another good webinar 95 next week we've got George Howell up from Saifu 360 and the topic is the fundamental principles of food safety understanding the link between hazard risk and control so hope you'll join us then but for now enjoy the rest of your day have a lovely weekend and we'll see you soon take care bye

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