Regulatory Requirements

The Food Processing Center Author

06/05/2019 Added

164 Plays

Description

In this lecture requirements associated with state and local regulations are described for reduced oxygen packaging. Included are also some examples of how to meet those regulations, such as when variances are required and temperature/time controls for different food products.

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[00:00:04.930]Okay, so my name is Andrea Bethke,
[00:00:06.560]and I'm with the Lincoln-Lancaster County Health Department.
[00:00:08.380]I am a food inspector,
[00:00:12.157]and could maybe be called someone
[00:00:14.840]who's kind of a subject matter expert in this, I guess.
[00:00:19.050]So, kinda start off, I've provided you guys
[00:00:23.030]with a copy of a section of the food code
[00:00:25.290]dealing with reduced oxygen packaging,
[00:00:27.230]and so when we're, you know, when we come to your facility
[00:00:31.880]and we notice you're doing something like this,
[00:00:33.560]this is what we're referring to
[00:00:36.790]to provide guidance on what you need to do
[00:00:39.260]to produce your food safely,
[00:00:41.570]and so I strongly encourage you guys,
[00:00:43.830]'cause I don't know the last time
[00:00:44.663]you guys maybe have looked at the food code,
[00:00:47.250]but I strongly encourage you guys to read it.
[00:00:48.733]It's kind of a foreign thing,
[00:00:50.260]and I think sometimes we are your contact with the food code
[00:00:54.050]so sometimes when a violation's occurred
[00:00:56.060]or maybe we're talking about some kinda process
[00:00:58.430]you have in your facility,
[00:00:59.460]we are your contact point for what's in the food code.
[00:01:02.200]So I said, yeah, I strongly encourage you to read it,
[00:01:04.810]'cause that's pretty much what we're referring to.
[00:01:07.800]Whoa, not going.
[00:01:10.916](student mumbles)
[00:01:12.050]Oh, a slide, okay.
[00:01:14.010]Slide, no, oh.
[00:01:16.340]Okay.
[00:01:17.590]So, you wanna reduce oxygen package in your facility,
[00:01:21.350]and so this is kind of an area
[00:01:25.260]where it gets kinda confusing for folks,
[00:01:27.970]and I would humanize us as inspectors,
[00:01:30.920]and sometimes it can be confusing for us too.
[00:01:33.250]We don't see it all the time,
[00:01:34.470]and so we have to refer to that a lot and interpret it a lot
[00:01:37.470]and look to FDA Annexes
[00:01:39.820]to kinda help us understand, too, how to better help you,
[00:01:42.900]and so there are some things that you might need to do
[00:01:45.910]if you're gonna reduce oxygen package in your facility.
[00:01:48.400]So, you might need a HACCP plan,
[00:01:50.890]you might need a variance,
[00:01:52.010]you might need to have your product validated.
[00:01:54.590]But, first and foremost, call us before you do it,
[00:01:58.010]'cause we can better help you
[00:01:59.830]and guide you where you need to go
[00:02:01.790]before you do something where we may say,
[00:02:03.480]you gotta stop, like right now, doing this,
[00:02:05.620]and we need to talk about your process
[00:02:08.330]before you continue this,
[00:02:09.510]or we might have to even throw away some product
[00:02:11.440]'cause we can't trust that it was done safely.
[00:02:13.540]So please call us, we don't want that to happen.
[00:02:18.160]So, what is a HACCP plan?
[00:02:20.300]So, it's a hazard analysis of critical control points,
[00:02:23.900]but really it just describes the process of a product
[00:02:26.450]from receiving to serving,
[00:02:28.070]and Andrea did a really great job
[00:02:30.120]of just kind of laying out that,
[00:02:33.860]you know, if you just kinda look at your,
[00:02:36.640]what you do in a facility, so you get your product in,
[00:02:40.624]you store it, you prep it,
[00:02:42.520]you might cook it, cool it, reheat it, hold it, serve it,
[00:02:46.670]so we're pretty much just asking you to lay that out,
[00:02:48.960]lay that all out and explain that to us,
[00:02:51.340]and then you need to look at,
[00:02:54.230]and this is where it gets kind of intimidating and scary
[00:02:56.960]is kind of identifying all the hazards,
[00:02:58.520]and that's why we're here today.
[00:03:01.580]Andrea and Jane just have kind of laid out
[00:03:04.100]where you need to look in the process
[00:03:05.620]and describe what kind of hazards that you're looking for,
[00:03:08.170]and as I said, that's the most intimidating part,
[00:03:10.390]so hopefully this kind of helped
[00:03:14.348]with developing that in your process.
[00:03:16.690]And then there's certain points of the process
[00:03:19.100]that you need to monitor
[00:03:22.280]and that, you know, action might be taken,
[00:03:26.228]and then records need to be kept,
[00:03:27.760]and so you might be asked to take logs at this point
[00:03:32.400]and monitor temperatures at certain points of the process,
[00:03:34.760]certain times, and that if an issue does occur
[00:03:37.970]that you need to take action to correct it,
[00:03:40.430]whether we discard or relocate it or whatever,
[00:03:42.940]and that those records need to be kept on file
[00:03:44.810]for us to look at when we come and do your inspection.
[00:03:48.560]Making sure I got everything now, okay.
[00:03:53.471]Oh, oh, other way.
[00:03:56.120]So, when do I need a HACCP plan for ROP?
[00:03:59.640]So, pretty much all processes need a HACCP plan
[00:04:04.350]according to the code,
[00:04:06.100]except for ROP items that are held at 41
[00:04:09.890]and removed from the package 48 hours after it was packaged,
[00:04:14.400]and it has to have that date and time on it
[00:04:17.240]and it has to be removed 48 hours after it was packaged.
[00:04:24.720]They've kind of, I think, before in the code
[00:04:27.010]they didn't have this,
[00:04:28.030]and then through some studies they've kind of found
[00:04:30.010]that with that time and temperature combination
[00:04:34.550]that the risk is low, and so that's enough of a barrier,
[00:04:38.130]and so they found that to be sufficient.
[00:04:41.270]But as I said, I've had facilities
[00:04:43.140]where, you know, it can be a struggle
[00:04:47.340]to get it out of that package in 48 hours,
[00:04:50.140]and so that's somethin' to think about,
[00:04:52.240]about the amount of product that you have.
[00:04:53.680]'Cause yeah, I think that that's kind of,
[00:04:56.000]in the past places that have tried to do this
[00:04:58.430]can't get it out of the bag in 48 hours,
[00:05:00.280]and that doesn't mean you have to throw it away,
[00:05:02.800]you just cut it out, take it out of the package
[00:05:05.050]and put it in a regular container,
[00:05:06.890]just get it out of the reduced oxygen packaging atmosphere.
[00:05:15.820]So, when do I need to provide the HACCP plan?
[00:05:17.540]So, by code a HACCP plan needs to be provided
[00:05:21.490]prior to the implementation
[00:05:23.210]of the reduced oxygen packaging process.
[00:05:25.177]And so once again, call us
[00:05:26.820]so we can better help guide you on what you need.
[00:05:30.240]So, what needs to be available for review?
[00:05:33.500]So, all those monitoring records
[00:05:35.860]that you're keeping at each critical control point,
[00:05:38.190]that would need to be available for us.
[00:05:41.340]The one part of the code that's really specific
[00:05:43.730]on how long you need to keep it
[00:05:45.820]is for sous vide and cook chill,
[00:05:47.000]that needs to be kept for six months.
[00:05:49.410]But really, that's just a good practice anyway,
[00:05:51.430]so that if there is an issue
[00:05:53.300]you have a time period where you can go back
[00:05:55.110]and you can look and see what happened on that day,
[00:05:58.260]just as a reference.
[00:06:00.150]Once again, yeah, check with your inspector,
[00:06:01.540]I can't stress that enough.
[00:06:02.870]I do have a question on that.
[00:06:04.380]Is sous vide, can you actually cook sous vide
[00:06:09.010]here in Lancaster County, is that--
[00:06:12.340]You can, so with the code you can do it.
[00:06:16.850]We're gonna kind of get to the specific part
[00:06:18.650]of the code on that,
[00:06:20.500]so hopefully that's gonna kind of address that,
[00:06:21.627]but if you have additional questions at that point
[00:06:24.380]then you let me know.
[00:06:26.600]So, what is a variance?
[00:06:30.060]So, it's pretty much,
[00:06:33.460]there might be times or certain process that you're doing
[00:06:35.730]that you might need to submit what's called a variance.
[00:06:37.930]So, it's pretty much saying that you're gonna do something
[00:06:41.060]that's not specifically addressed from the code,
[00:06:43.130]i.e. vary from the code.
[00:06:45.620]So, with that you need to provide evidence
[00:06:48.030]of how hazards are gonna be controlled,
[00:06:50.600]whether with your HACCP plan or validation studies,
[00:06:54.620]or a validated process that's been done in another facility
[00:06:58.990]and you're gonna implement it in yours,
[00:07:00.480]so there may be validated processes
[00:07:02.730]that are already out there,
[00:07:03.670]and you're just going to do that in your facility.
[00:07:09.740]And so what is validation?
[00:07:13.820]Your recipe and process are reviewed
[00:07:15.620]by an approved process authority,
[00:07:17.310]and that is right here at the UNL Food Processing Center.
[00:07:23.070]You guys have a great opportunity here
[00:07:25.210]to kinda meet and greet those folks
[00:07:26.690]of who your Food Processing Center is,
[00:07:29.630]and kinda get to know them.
[00:07:33.732]With that, it's not,
[00:07:36.840]it's ensuring that your product is safe
[00:07:39.930]when you're doing an alternative process
[00:07:42.070]that has not already been tested and validated
[00:07:45.410]and put in the code,
[00:07:47.500]and so you wanna make sure
[00:07:51.860]that you follow that recipe the same way every single time,
[00:07:55.120]so the same measurements,
[00:07:56.460]the same time that you're doing that process
[00:08:00.790]is the same every single time
[00:08:02.190]to ensure that that process is safe.
[00:08:04.490]So there's a lot of extra monitoring with that, too,
[00:08:07.880]with the validated process.
[00:08:10.320]So, when do I need a variance when doing ROP?
[00:08:16.770]In the code there's specifically laid out secondary barriers
[00:08:20.590]and so if you're not using any of those
[00:08:23.410]then you're gonna need a variance,
[00:08:25.890]so for products that do not have
[00:08:27.760]a validated secondary barrier mentioned in the code.
[00:08:31.950]So examples of processes that require a variance,
[00:08:34.350]so just for example, like in sous vide
[00:08:37.330]you know you wanna cook chicken
[00:08:38.470]for a lower temperature for extended period of time,
[00:08:41.080]that varies from the code.
[00:08:42.470]The allowed cooking temperature for chicken is 165,
[00:08:45.460]you're cooking below that,
[00:08:46.770]so you'd have to show us with a HACCP plan
[00:08:49.530]and a validated process that that is still meeting
[00:08:54.060]that same kill step for that product.
[00:08:57.220]And then another example
[00:08:58.220]would be holding ROP cooked pulled pork
[00:09:00.650]for 30 days at 41 degrees,
[00:09:01.990]and we'll kinda see later why that would be a variance,
[00:09:04.370]'cause in the cook chill sous vide
[00:09:07.710]there's certain date mark requirements that are there.
[00:09:11.890]Okay, down.
[00:09:16.250]Okay, so allowed secondary barriers.
[00:09:19.490]So, with this, this kind of ties in
[00:09:23.860]to Andrea's presentation,
[00:09:25.540]so if you kind of refer back
[00:09:27.830]it kind of shows why these are there.
[00:09:30.860]So a water activity of .91 or less,
[00:09:35.060]a pH of less than 4.6,
[00:09:37.480]and a cured meat that was processed in a USDA facility,
[00:09:41.230]and for that particular kind of product
[00:09:45.760]they are cured with nitrates or nitrites,
[00:09:48.270]and that is a really great barrier
[00:09:51.643]for clostridium botulinum.
[00:09:53.970]Not so much listeria, listeria, you know,
[00:09:55.730]is really good at recontaminating product
[00:09:58.090]after it's been processed, and so it doesn't really work,
[00:10:01.710]listeria loves deli meat and lunch meats,
[00:10:05.555]and so then I kind of put a point here
[00:10:08.130]that a lot of deli turkey, chicken
[00:10:11.130]is not treated with nitrates or nitrites,
[00:10:13.360]so that would not fall underneath
[00:10:15.450]that particular secondary barrier.
[00:10:18.780]And then raw products with competing organisms.
[00:10:23.830]And so I kind of had a point that even for that,
[00:10:29.260]back in 1987 they had some folks
[00:10:33.720]that had this ROP'd package of cabbage,
[00:10:39.010]and they temperature abused it
[00:10:41.880]and all four of them came down with clostridium botulinum,
[00:10:45.570]so even then you can still have issues there
[00:10:47.900]with temperature abuse.
[00:10:49.690]So, all those items,
[00:10:51.160]and I have asterisks here, too, as well.
[00:10:56.070]It's one of those things I always tell folks,
[00:10:58.460]so if you have a product
[00:10:59.630]and you feel like it's acidic enough
[00:11:01.180]or has a low water activity,
[00:11:02.720]we can't look at that and know,
[00:11:04.690]so that would be another,
[00:11:07.310]it might be considered another special process
[00:11:09.290]'cause you're saying I've acidified it enough,
[00:11:11.420]or I've reduced the water activity enough,
[00:11:14.410]and so that might require a whole other HACCP plan for that
[00:11:18.240]to make sure that that product is meeting that,
[00:11:20.920]and then you're reduced oxygen packaging that as well.
[00:11:25.910]So with this secondary barrier with the code,
[00:11:28.780]it used to be 14 days but it changed to 30 days
[00:11:32.410]for the shelf life if kept at 41 and below.
[00:11:40.140]So, here we go for sous vide and cook chill.
[00:11:43.730]This is in the code,
[00:11:44.760]or the specific, you have something Brian?
[00:11:48.870]Yeah, I missed,
[00:11:50.980]was cheese included in that last one?
[00:11:53.077]Not with the secondary barrier,
[00:11:55.150]there is a specific portion of the code
[00:11:57.560]that deals with cheese,
[00:11:58.950]and we're gonna get to that at the end. So yeah, it's there.
[00:12:01.550]And that's your favorite part, Brian,
[00:12:03.250]you're like the cheese guy at the health department.
[00:12:05.210](laughs)
[00:12:08.260]So yeah, so there's a section of the code
[00:12:10.160]that deals specifically with sous vide and cook chill,
[00:12:11.917]that's another reason why we encourage you guys to read it
[00:12:14.010]'cause not all of it's up here,
[00:12:15.760]but these are what I thought
[00:12:16.670]that were some of really the important parts.
[00:12:21.640]It needs to be prepared and consumed
[00:12:23.780]on site within the business entity,
[00:12:25.330]so you cannot sell it directly to a customer.
[00:12:30.658]And I guess that's kinda confusing that it's,
[00:12:32.920]you can't package it and sell it directly to a customer
[00:12:35.660]if that helps clear that up.
[00:12:39.782]You can't sell it to another business entity either.
[00:12:42.160]And there was a case in the '90s
[00:12:44.450]of some folks that purchased a ROP bag of clam chowder
[00:12:50.910]from a grocery store, and they brought it home,
[00:12:54.760]and then they temperature abused it
[00:12:56.580]'cause there was no really label
[00:12:58.460]of how to handle that product,
[00:12:59.740]it didn't say keep refrigerated or that it was perishable,
[00:13:02.490]and so, yeah, you just don't know
[00:13:03.960]what your customers are gonna do with that product
[00:13:06.320]when they take it home, so that's why that rule is there.
[00:13:12.070]And it needs to be placed in the bag prior to cooking,
[00:13:16.190]or placed in the bag prior to cooling below 135,
[00:13:19.700]and so that reasoning is that, you know,
[00:13:23.520]if it's hot when you package it
[00:13:26.230]it's not gonna be recontaminated, it's hot.
[00:13:29.390]And then prior to cooking, you know that
[00:13:32.250]you're going to immediately cook it after packaging,
[00:13:36.550]and so it reduces the risk there.
[00:13:39.120]And then it needs to be,
[00:13:41.550]once again, so then you can't have
[00:13:42.840]any other kind of contaminating factors,
[00:13:44.810]after it's been cooked it needs to be cooled
[00:13:46.640]to 41 in the package.
[00:13:52.020]And I've found, like for cook chill and sous vide
[00:13:55.860]it really can be a great way to cool products in the bag,
[00:14:00.120]you can take a big trash can size container
[00:14:04.610]and fill it with water and ice,
[00:14:06.780]and as long as you have really good distribution
[00:14:08.770]of that bag in that kind of setting
[00:14:12.300]it can cool very quickly.
[00:14:13.960]Sometimes some places, I think, inspectors have found
[00:14:18.090]places might stack a bunch of bags together like in a sink
[00:14:22.180]and then dump all the ice on top,
[00:14:24.000]and then right, yup, yeah, you're shaking your head no,
[00:14:26.270]it won't cool very well like that,
[00:14:27.870]it doesn't have really great contact with the ice
[00:14:30.810]and you're reducing the surface area
[00:14:32.610]kind of contact with the bags.
[00:14:35.970]So here's where it can be kind of complicated,
[00:14:39.750]really, I guess it's all complicated,
[00:14:40.583]but this is really kinda complicated to keep straight
[00:14:44.810]with the shelf life product with sous vide and cook chill.
[00:14:48.010]So once again, these are other kind of barriers
[00:14:49.910]that they've found, or that is a sufficient barrier
[00:14:53.070]to reduce the risk of both C. bot and listeria.
[00:14:59.381]When you cool it to 41,
[00:15:00.660]you can treat it just like a regular product,
[00:15:02.543]like the regular shelf life that you're quite familiar with
[00:15:05.470]and have it for seven days.
[00:15:08.240]You can chill to 34 within 48 hours,
[00:15:12.320]and can store it for 30 days,
[00:15:14.570]and if you kinda look at that 34
[00:15:18.601]and you look at C. bot type E and listeria,
[00:15:23.046]that's kind of a temperature
[00:15:23.990]where they really kind of slow down their growth.
[00:15:29.370]You can store in the freezer indefinitely,
[00:15:31.620]and that's a great way to store.
[00:15:33.710]'Cause I would say, you know,
[00:15:35.440]if you're gonna chill to 34 and hold it at 34,
[00:15:39.130]you're gonna have to really have
[00:15:40.020]a piece of equipment that can do that.
[00:15:41.960]If you're trying to do that in a piece of equipment
[00:15:43.740]that you're in and out of,
[00:15:45.550]I don't think it's really gonna be able to maintain that.
[00:15:47.850]So in a freezer it's designed to be frozen,
[00:15:50.910]and so you've got bigger problems
[00:15:53.200]if your freezer can't be frozen.
[00:15:58.190]Another point is that the unit
[00:16:00.178]needs to be electronically monitored
[00:16:02.681]so you have a continuous monitoring system,
[00:16:05.340]and there's local places that offer that
[00:16:09.130]that you can get that type of service and monitoring,
[00:16:14.290]and it needs to be visually checked at least twice daily.
[00:16:16.870]Then, once again, because this is so important
[00:16:20.900]getting it out within seven days at 41, or 30 days if at 34,
[00:16:26.260]it's gotta be labeled with a product name
[00:16:27.910]and the date packaged.
[00:16:32.200]Fish need to be frozen before, during, and after,
[00:16:35.390]and I think Andrea talked about that.
[00:16:36.993]It's really important
[00:16:38.460]because C. bot type E occurs naturally in a fish's guts
[00:16:45.910]and their spores germinate as low as 34 degrees,
[00:16:49.900]and so it's just really, really important
[00:16:52.510]that it's maintained frozen.
[00:16:57.090]I think it was alluded to in one of the previous lectures
[00:16:59.380]that there's been a few outbreaks in Europe
[00:17:02.840]associated with your hot, smoked, vacuum packed fish,
[00:17:06.600]or vacuum packed scallops,
[00:17:08.420]so it's something that's occurred
[00:17:10.770]and is found to be an issue.
[00:17:12.660]Also, just another tidbit,
[00:17:16.350]that if you're getting commercially packaged ROP fish
[00:17:19.890]that there's a label on a lot of them now
[00:17:23.240]that says it needs to be removed from packaging
[00:17:24.850]prior to thawing,
[00:17:25.683]and I find a lot of places that, you know,
[00:17:27.270]because they're just stockin' the cooler
[00:17:28.820]and they don't see that label,
[00:17:30.510]but that's why it's really important
[00:17:32.060]that you've gotta get it out of the bag,
[00:17:33.400]so you need to remove that fish prior to thawing
[00:17:38.479]so then it reduces the risk of that,
[00:17:40.850]it eliminates the risk of that growing.
[00:17:43.670]I think there's an exception, too,
[00:17:44.820]that you can thaw with cold, running water
[00:17:49.770]completely submerged and keep it in the package,
[00:17:52.400]but you have to immediately get it out after that.
[00:18:00.320]And Brian's favorite part.
[00:18:01.570]So, for cheeses--
[00:18:03.460]Oh, Andrea, I had a (mumbles).
[00:18:05.210]Yeah, sure.
[00:18:06.390]What about the sealed air type barriers?
[00:18:11.710]What about the sealed air barriers
[00:18:13.590]that allow oxygen-- The 10-K packaging?
[00:18:17.120]Is that what you're referring to?
[00:18:19.570]So, and you guys might be aware, I think,
[00:18:20.793]that that might have been at a facility.
[00:18:22.780]So, with fish there is a type of packaging,
[00:18:28.240]it's like 10-K, and it allows for enough air transfer,
[00:18:31.520]and so the FDA does not consider that
[00:18:33.970]reduced oxygen packaging,
[00:18:34.940]so that's another method that you could use
[00:18:39.730]to package your fish and reduce the risk of that.
[00:18:46.440]Yeah, okay.
[00:18:48.540]So, for cheese.
[00:18:52.636]Hard cheeses, pasteurized cheese,
[00:18:54.280]and semisoft cheese with no ingredients added
[00:18:56.330]can be ROP'd without a variance.
[00:19:00.830]You can't brine it or add any other ingredients to do that,
[00:19:03.820]'cause that could add contaminants at that point,
[00:19:06.840]and you cannot ROP soft cheese like brie,
[00:19:09.870]cottage cheese, et cetera,
[00:19:11.150]just because of the water activity of that product,
[00:19:13.940]and it can be held for 30 days and then discarded.
[00:19:19.530]So, things that I would definitely encourage to ask yourself
[00:19:23.030]is do I have the right equipment, do I have enough space,
[00:19:28.670]are my staff and managers capable
[00:19:31.000]of taking on this load and monitoring?
[00:19:33.070]Because with a HACCP plan
[00:19:34.730]it's not just a binder you stick on the shelf
[00:19:37.350]and you don't ever do anything with,
[00:19:39.320]you have to be checking and monitoring all day every day
[00:19:42.790]when you're doing these processes,
[00:19:44.380]and so you really have gotta think,
[00:19:47.330]do I have enough staff
[00:19:48.440]and are my staff capable of that kind of commitment?
[00:19:51.340]I mean, we strongly encourage you
[00:19:52.730]to be monitoring and checking your processes
[00:19:54.700]in your facility anyway,
[00:19:55.640]but this one, you aren't required to keep logs and do that.
[00:19:59.220]You're required to keep logs and monitor these processes.
[00:20:04.220]Do I have enough, oh, yeah,
[00:20:06.300]do my staff have time, think about their barriers,
[00:20:08.740]like, you know, if they have enough time
[00:20:11.330]to do these kind of tasks,
[00:20:12.990]and then I said, have I talked to my inspector as well.
[00:20:16.290]All right, I think that is pretty much it,
[00:20:18.930]does anyone have questions?

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