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Apologies if this was addressed earlier this month and I missed it — were any of the flocks that USDA has confirmed infected with H5 in Washington state infected with B3.13?
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Yes, the confirmation in question was B3.13.
Short answer:
We haven’t heard of a Washington association with the currently implicated ingredients, but you may consider also asking WSDA as well – as they would know more about Washington-grown commodities. The current case we have in the state is associated with consumption of a Quarter Pounder in Colorado, so we haven’t identified a case from eating foods in Washington.
Long answer:
Preliminary traceback by FDA indicated that slivered onions served on Quarter Pounders are the likely source of contamination.
We also asked corporate McDonald’s office if stores in Washington received any of the implicated ingredients, but they indicated none of the slivered onions used in Colorado were distributed to McDonald’s locations in the state.
We are watching for additional details from FDA to see if the onions are confirmed as the cause and if they had additional distribution, such as to other products or retailers. We have not had any indication from federal investigators or any partners in the state that Washington is directly affected.
FDA is still working to confirm the source and to determine if the contaminated ingredients were distributed to other businesses.
Taylor Farms, the supplier of slivered onions for affected McDonald’s locations, initiated a recall of yellow onions associated with Colorado (Taylor Farms Colorado Foodservice Voluntary Yellow Onion Recall - Taylor Farms). We haven’t identified any Washington locations that received the recalled products.
Do you know if any of the onions linked to the McDonald’s E. Coli outbreak this year were grown or stored in Washington state? If so, has the state been able to test any of those onions for E. Coli?
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The WSDA is investigating the E. coli onion outbreak in collaboration with the FDA. We can confirm we are investigating a farm in Washington state linked to this outbreak. Additional information is unavailable at this time.
CDPH continues to monitor and investigate the current outbreak of E. coli in a number of states. Federal investigators from the FDA indicate onions may be a source of this outbreak, and Taylor Farms, a California farm and the supplier of slivered onions for affected McDonald’s locations, initiated a recall of yellow onions. A thorough investigation update is available from the CDC. At this time, there have been no reported cases of E. coli in California linked to this outbreak.
CDPH is unable to release additional investigative details or records at this time, as these are exempt from public disclosure under the California Public Records Act (Government Code 7923.600-7923.620).
Christopher Gardner, DGAC [01:31:45]
If we’re trying to get Americans to lower their saturated fat intake, here are some things that could might or should work. We’ll start with strong.
And this is really old news. Butter is not back. Butter is worse for your LDL cholesterol than all kinds of oils and spreads, higher in unsaturated fat. This really isn’t new news. It’s just reinforcing what there’s a large database for.
This isn’t morbidity or mortality, but certainly the RCTs looking at blood lipids in particular blood lipids, and LDLC in particular, suggest that you would do better swapping out your butter for those unsaturated plant oils and spreads.
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Christopher Gardner, DGAC [01:32:30]
Five of the conclusions were moderate. And the first bullet point that’s listed here is a little bit of a head scratcher, but it was pretty stunning when we looked at it, how consistent it was.
These are all prospective cohort studies looking at CVD morbidity.
And if you take processed and red meat versus dairy products, swapping out the red meat for the dairy products was consistently associated with lower risk.
So what does that mean, if I’m trying to decide if I should have a steak or a glass of milk tonight that doesn’t really seem like a practical substitution, but could have been yogurt could have been cheese.
What was really more stunning was how consistent and how many perspective cohort studies had looked at that question and it ended up with a moderate grade. So I think that merits looking into a little bit more of the details of what that practical swap would be, but it ended up in our moderate favorable difference list.
The next bullet point there is substituting processed or unprocessed red meat. So we had total, we had processed, we had unprocessed and this was strikingly consistent for plant sources of protein.
That would be our beans, peas, lentils, legumes, nuts, or whole grains or vegetables. And actually there were enough, in each of those separate categories that they generated separate conclusions.
At one point it was just gonna be plant foods, but there were enough that we separated them out. Each one warranted a moderate conclusion.
Again, the outcome is these are prospective cohort studies, CVD morbidity. And the big thing to think about here is the twofer. So for this difference that you’re getting not only are the plant sources of protein, whole grains and vegetables, much lower in saturated fat than processed or unprocessed or total red meat, but they also have fiber. And we weren’t looking specifically at what those separate constituents were. That was not part of the question.
When you’re looking at food based sources, you’re just taking it for what it is. It may have more antioxidants, it may have other differences. Fiber would be the obvious one for a mechanism for lowering LDL cholesterol, but that’s not what we’re looking at. We’re only looking at the associations of the food sources.
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Christopher Gardner, DGAC [01:37:01]
Almost as interesting were some of the differences, some of the comparisons where there was no difference. So we have five conclusion statements with a moderate grade where we didn’t see a difference.
So look what these bullet points are. So swapping one form of dairy for another form of dairy and this is prospective cohort studies. And think now that you know, these are, those are both sources of saturated fat.
So the magnitude of the saturated fat difference, isn’t going to be as large as swapping out some form of animal source of saturated fat for a plant source where the plant source would be much, much lower.
No association between processed or unprocessed red meat with other kinds of animal sources, white meat, or eggs, again, less of a difference there, and no fiber included in the white meat or eggs. So maybe less of an opportunity for that shift.
The last one is a little odd. We were looking at substituting white meat for other sources. So I don’t know if you caught this, but in the beginning we were talking about dairy and red meat and tropical oils.
But because we were looking at all the comparisons where data were available, we also were able to look at white meat versus plant-based foods or fish seafood. And that wasn’t enough of a shift in saturated fat to see a difference.
So that was a moderate conclusion for no difference there. So yes, for red meat and swapping out, but not so much for white meat.
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Christopher Gardner, DGAC [01:46:46]
So picture someone eating fewer hamburgers and one set of people replaces the hamburgers with french fries and another one replaces it with lentils. Right?
And so if all you’re doing at look is looking to see who eats fewer burgers or some source of saturated fat, the comparison group is everyone else. And so some of them might have been a beneficial change and some of them might have been a worse change. And what you’re getting is no change.
And so by doing this substitution model, you’re saying, wait, let’s separate the folks who are substituting refined grains for red meat, from the ones who are doing beans, peas and lentils for red meat. Oh my gosh.
Now that we’ve separated those out, we can see and do some statistical analyses that there is an impact, but you can’t just lump them all together as the low red meat eaters, you have to see what other, what they were replace– if you’re eating less red meat, you’re eating more of something and they don’t all have the same effect on your health.
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Christopher Gardner, DGAC [02:03:25]
In our world of food science, the more rigorous studies are the easier ones to make clean. So if it’s just a swap of saturated fat for polyunsaturated fat, that’s very clean. You don’t have to change carbs, you don’t have to change calories. You don’t have to change anything else who, what we’re seeing is four fifths of the country isn’t meeting the saturated fat guideline.
So how could you get a bigger shift and how could you get a bigger health benefit if you’re restricting yourself to something where it can be very rigorously compared without changing other variables, you’re selling yourself short.
What if you got rid of some of the saturated fat and added fiber and had fewer calories and had something else, if you really want to see a health benefit, it’s going back to the patterns, right?
So a lot of our talk for the whole 20 months has been on patterns. And this is a portion of that pattern.
It fully supports the patterns that we’ve been finding that healthy pattern. It’s more beans, peas, and lentils and less red meat, less sugar sweetened beverages, more whole foods.
It ties in, but when you put it together, that’s been the beauty of the patterns, it’s all these things together. So in this particular comparison of saturated fat, it really has been important to move past just the swap of one type of fat for another type of fat, without appreciating the benefit of putting that in the larger context of food choices of swapping things out.
If we want to make a meaningful difference, some of those smaller choose leaner, choose the lower fat version, isn’t going to get us there, is what I would suggest we’re seeing from the evidence base that we reviewed.
I wanted to follow up with a clarification regarding this statement: https://ag.colorado.gov/press-release/colorado-grown-onions-not-linked-to-e-coli-outbreak
Does that mean that the Taylor Farms facility in Colorado that was linked to the E. Coli outbreak was only supplying onions grown in other states? Do you know what states those were?
That is correct. The onions under investigation from the Taylor Farms processing facility in Colorado Springs were not grown in Colorado. The FDA is continuing the traceback investigation. I do not have information on what other states they source their onions from.
For the most up-to-date info on where the onions were grown, please contact the lead agency – the FDA. They are leading the recall investigation. You can contact the FDA Office of Media Affairs at FDAOMA@FDA.HHS.GOV for more information
Sameera Talegawkar, DGAC [02:11:05]
So we did have this question and, can you describe the limitations of the data, because it was a bit frustrating, like after looking at everything and there was a lot of public comments that we received on this particular question. So I was wondering if you could just talk a little bit about that and if you have any specific research recommendations, regarding this question, like for future committees, you know, just to consider for the research community in general so that their body of evidence can be considered by future committees.
Deanna Hoelscher, DGAC [02:11:40]
So, when we started that systematic review, one of the issues was how do you classify ultra processed foods because there’s several classification schemes right now.
So Nova is the most well known, but there’s others as well. And so we wanted to be more inclusive.
So we let the authors of the study determine what they meant by ultra processed foods. So when you got that, you had some kind of, you had consistent types of foods show up, but it was hard for us to come up with a succinct definition for ultra processed foods. And that’s not available in the literature now, although several groups are working toward that right now.
So I think until we get a better definition for what we mean as ultra processed foods, it’s going to be difficult to look at this.
The other issue was a lot of these studies that we reviewed were from other countries. So what they had as ultra processed food might be different than what you would find here. So there were several issues associated with that.
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Edward Giovannucci, DGAC [02:13:07]
It’s obviously an important issue, but, you know, I think it’s more a question of how it’s been studied or is being studied and it’s a relatively new area of research.
But you know, it’s also important to note that like the foods, like all the foods that are recommended as part of a healthy dietary pattern, would generally not be considered ultra processed foods by any standard definition.
And, we do mention sugar sweetened beverages, items like that, that would be likely considered ultra processed foods.
So I think it’s the– the pattern somewhat covers ultraprocesed foods indirectly, because you know, part of nutrition is, or part of the pattern rationale is, you know, it’s not just what you’re eating, but at the same time what you’re not eating.
So, I think it, it kind of covers ultra processed foods indirectly, but I mean, I think it’s certainly something that as more research is coming out, hopefully in the future we will be able to make more direct statements regarding it.
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Christopher Gardner, DGAC [02:14:56]
There’s a– the public is very interested in this because it’s all over the media, right? And it just seems like such a timely opportunity to address this, given that we’re revising the Dietary Guidelines for Americans.
But the reality here is most of the publications are observational epi studies. These prospective cohort studies that have data from 30 and 40 years ago. And so we have two issues.
One is we didn’t have that level of ultra processed foods 30 or 40 years ago. So they were, they weren’t actually even there. And the second one is the most current definition is clearly Nova. Nova actually isn’t as much nutrients as it is the purpose of the ingredients that were added. And the main categories there is called cosmetic additives. And there’s another really bizarre category that’s called of no or rare culinary use, which means it’s only used in industrial settings. You wouldn’t find it in a restaurant. You wouldn’t find it usually at home. And it’s an extensive list.
It’s really, really, it’s so extensive that nobody’s ever had the time to look at each one of these additives one at a time they’re sort of all grouped together. They’re not in the data sets. So as people move forward with these studies, they are saying, okay, I’m looking at what items are in the food frequency questionnaire data that we collected. And I’m kind of assuming the ultra processed ones are in this group and in this group, but there’s a huge limitation in the assessment of that and the conclusions that you can draw.
And so unfortunately as much as the public is seeing this in the headlines and as much as the papers are coming out, until we have better tools for not only defining it, but even after we’ve defined it, finding those foods that we know have the cosmetic additives that, oh my gosh, that that’s really a long way off.
So we can make some very practical recommendations at this time. But the level of evidence can’t get anywhere further than limited because of the difficulties with assessment would be my comment.
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Deirdre Kay Tobias, DGAC [02:20:36]
I think in five years from now, that’s not going to be an issue that goes away. And we’ll have a lot more clinical, experimental and epi evidence.
The definition, you know, as we know, hasn’t been intended to capture like a health outcome. It’s for like exclusively delineating by processing techniques.
So its intent is, what it is, but I think for the next five years, the research is going to explode. So revisiting, it will probably be if anything, even more of a priority.
And then the other aspect of that was, you know, as we move towards a more, I don’t know, acceptable definition if one’s actually needed or a one that can be more easily communicated if that’s necessary in the end, is one consideration.
But I think we really felt it was more the volume of literature being sparse than the definition alone explaining that because we ran into that same issue with all the patterns we looked at being vague or not quantitative.
So in five years, hopefully this isn’t sort of punted again for another five.
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Sarah Booth, DGAC [04:34:01]
So moving on the assumption that we go to a more inclusive, flexible dietary pattern, next slide, please.
First we really want to modify the order of the protein food subgroups to emphasize plant sources. And this was discussed in a number of the subcommittees.
So when we talk about protein foods, instead of starting with meat, poultry, and eggs, to seafood, to the plant based, we would flip it.
We’re proposing to flip it so that the nuts seeds and soy products are listed first, then seafood, and then meat, poultry, and eggs.
I wanted to stop there because there’ve been different discussions in different subcommittees about even the internal order within those food subgroups. But I wanted to see if people were comfortable with this. And if there were any changes within the protein foods that we’re listing here, because there’s another big change coming up.
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Christopher Gardner, DGAC [04:36:15]
So for the meats, poultry and eggs. So part of what we saw in all of our analyses were that the red meats, whether they were processed or not, were the ones to reduce more than the poultry or the eggs. So I would’ve put them very last.
So last category, I would’ve put the meats last within that category.
Sarah Booth, DGAC [04:36:40]
So eggs, poultry, and meat. Does anybody have any objection to that?
And so Christopher, just so I’m clear, I’m understanding this is really being driven by the systematic review evidence?
Christopher Gardner, DGAC [04:36:56]
Yes. So what we did for sources of saturated fat, what we did for patterns, it was most often what you needed to reduce were the red meats, whether they were processed or unprocessed.
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Sarah Booth, DGAC [04:37:24]
So this is where communication is going to come in. As we know, as everyone knows, we’ve had a great deal of discussion among the committee members in our public meetings about where do you house beans, peas, and lentils. And this becomes really challenging.
For example, when you’re looking at the healthy vegetarian pattern where you have beans, peas, and lentils, both in vegetables and protein foods in the healthy U.S. style, it’s all in the vegetables. Please note there are different units associated with the different food groups.
So when beans, peas and lentils are in the vegetable group, those are cup equivalents per week when they are in the protein foods, they’re ounce equivalent a week, which has perhaps been quite confusing as well.
When people were thinking about substitution, we are proposing, and this is again proposing for reaction, that beans, peas, and lentils be taken from the vegetable group and entirely housed in the protein foods. Again, aligned with the systematic evidence to encourage plant sources.
And it will go first, then the nuts and seeds, then the seafood. Oh, and we’ve already see, we’ve already got eggs, poultry, and meats.
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Sarah Booth, DGAC [04:39:05]
The implications of this, I want to draw your attention to, it looks like we’re recommending Americans eat less vegetables because you’re pulling a food, a sub food group or a subgroup out of vegetables and putting it into protein foods.
And we’re telling Americans, they need to eat– It looks like we need to eat more protein foods.
I think the most important thing to realize is people do not eat enough vegetables already. We’re not instructing– we’re not saying that people eat need to eat less. It’s just the beans, peas, and lentils would be put in protein foods. There would have to be a very strong emphasis on how to communicate that to the U.S. public.
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Angela Odoms-Young, DGAC [04:40:04]
I really don’t like this. I know I sounded really strongly about it, but I don’t.
I think it’s trying to prescribe something. I actually don’t like the label protein foods, I think it is somewhat confusing in itself, but that’s– I know that there’s been, you know, focus groups and other things because of that people liked the idea. It was changed for a reason.
I actually think beans, peas and lentils should be in its own group, but that’s another story. I think there should be a group that’s beans, peas, and lentils.
But, to me, it’s almost like in the translation, let people put– we are trying to force people in– we’re going to move it. And we are going to force people to make it a protein food.
My preference, as I said, would be to make it its own group. But I think it’s okay to be in the vegetables, because we still do want to reinforce that there are some cultures that eat beans, peas and lentils as vegetables, you know? So I think it’s okay to be in the vegetable group. I actually like it in the vegetable group.
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Edward Giovannucci, DGAC [04:46:40]
From a strictly scientific perspective, I don’t like distinguishing protein, I mean, animal and plant protein. Because you know, probably the health effects have actually very little to do with the protein, but what comes along with it or doesn’t so like it’s like the fiber and all the micronutrients that are important.
So protein is really not an important issue from, from that perspective, but a lot of people feel that protein is important. I think it’s one of the few items that people were exceeding and a lot of people think at least, people that I talk to, well, you have to eat meat and you have, you know, that’s where you get your protein.
So I think a lot of people don’t even think of like beans and peas as accounting for protein. So I think that would be a potential advantage of including it as a protein food.
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Deirdre Kay Tobias, DGAC [04:48:23]
I think one thing that surprised me from our modeling was the amount of protein in the diet comes only half from the protein food group, that a lot of the actual nutrient protein comes from all the other groups together.
So putting more protein sources in the protein category makes a little bit of sense just to have it more of an actual, here are your main protein sources, behaviorally, because the calculus at the end of the day is the same, but behaviorally, I think there is sort of a branding crisis when it comes to protein thinking automatically meat.
And if there are more plant sources of proteins in the protein category that could help overcome that mislabeling or misnomer or misinformation by having it more prominently, not just all that meat line.
But I also think that that’s where we would probably offer more flexibility in our swaps where we would have increased in like plant based. That’s going to get increasing beans peas and lentils at the expense of some of those other meat products, right? Not so much to displace vegetables, right, that are in the vegetable category.
I don’t know– I haven’t really thought about it being its own line item, but I think there are a lot of benefits of having it as a protein. I do appreciate the cultural perspectives of it really acting more like a vegetable in menus, so that, there will be I think some key translation needed there.
And in terms of a table you could easily have like ounce equivalence in parentheses and cups as the main unit. I think that that’s not much of a problem.
But I see a lot of pros for it being in the protein in terms of communication and helping emphasize protein comes from more than just animal products, because right now I think that’s what most people think you have to have your meat to get protein. And from all of the modeling we see, that’s just simply not the case.
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Chris Taylor, DGAC [05:18:30]
In the encouraged recommendations to shift to nutrient dense plant-based meals, this is kind of a– is it a terminology thing of encouraging people whose from data analysis, eating less plant-based meals, or is it a conceptual framework to say that the dietary guidelines are promoting more plant-based?
Because plant-based has a tendency to be used as a code word for vegan, as opposed to eating more plant protein or eating more plant products. Because if you look at the recommendations in the HUSS, it’s a foundation of grains, it’s a foundation of fruits, it’s a foundation of vegetables with some meat, poultry and eggs and dairy products, seafood, which doesn’t mean that it’s vegan, but it is more plant based.
So the terminology here in terms of what that’s like– what’s the concept that we’re really trying to convey? And that is my question.
Sarah Booth, DGAC [05:19:42]
Chris, you’ve raised a really good point and I know there’s been a lot of discussion, because different words and different terms have different connotations. And I think this is where a good discussion would come out. So I’m hoping that’s, what’s going to come out, but you’ve raised a really good point. And I don’t think that we landed on perhaps the perfect term yet.
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Heather Eicher-Miller, DGAC [05:20:12]
I’m not a big fan of the first one there to encourage shift to nutrient plant-based meals, because I also feel like this is kind of disregarding the dairy, the dairy and fortified soy group.
And we know that a lot of, also, not just because of dairy, but just are animal sources of many nutrients in general are more bioavailable. And, I think in particular for our growing age groups are adolescents and kids that they’re already not having enough from like the dairy group.
And it’s so important for bone health that these nutrients, that they’re getting bioavailable sources. So I just feel like the way that that is written there, it’s like deemphasizing some of those really important food groups for nutrients that are already under consumed.
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Christopher Gardner, DGAC [05:21:32]
I would agree that plant-based in the past was very much more inclusive. This isn’t plant restrictive or plant exclusive. This is plant-based and it’s shifting.
A lot of people are using plant-based to mean vegan, which is pissing me off because vegan already has bad connotations and now people are gonna be angry that they just switched the word, but they kept the vegan thing.
But I think plant forward may work. I don’t really want to answer that question now. I just think we should be careful about it just could be plant foods. More nutrient dense plant foods could be an option or plant sourced foods, right.
This also brings up the plant-based meats, the plant-based dairy, the plant-based, the fake things. So we’ll have to be careful there, but to build on the last point, maybe it needs to be specific by age group, right?
So Heather for the adults, the dairy, I don’t think would be as important. I didn’t really see that as shifting away from dairy, but I totally recognize your point for kids that, that might carry across for kids. So maybe this needs to have an adult one because when we get to saturated food sources of saturated fat tomorrow for adults, it’s going to be pretty clear to switch to more plant sourced foods.
And so maybe shift to more, not just to shift to, and there’s going to be a lot of terminology questions. I’m happy to help if I can, but it is confusing at the moment.
We are not seeing general decreases in pneumonia over the last few months.
Is mycoplasma continuing to trend up in children ages 2 to 4 years old?
In August 2024, the percentage of pneumonia-associated emergency department (ED) visits with an M. pneumoniae-related diagnostic code peaked at 10.7% for those by persons aged 2–4-years and 9.8% for those by persons aged 5–17 years. Since then, the percentage has dropped slightly for 2–4-year-olds.
Are there some regions currently seeing higher mycoplasma rates than others?
Though we have seen an increase in every region, the highest levels are in HHS Regions 6 and 7, while the lowest are in HHS regions 9 and 10. It is important to note that while the National Syndromic Surveillance Program (NSSP) collects data from the vast majority of emergency departments, it isn’t 100% so there may be regions of the country with more or less reporting.
What share of pneumonia diagnoses right now are mycoplasma?
As of September 21, 2024, the percentages of pneumonia-associated ED visits with an M. pneumoniae-related diagnostic were 1.8% among people of all ages. Specifically:
· 4.8% (53/1117) among persons aged 0–1-year
· 6.8% (133/1956) among persons aged 2–4-years
· 6.7% (418/6241) among persons aged 5–17-years
· 1.6% (126/8121) among persons aged 18–44-years
· 0.4% (38/9130) among persons aged 45–64-years
· 0.2% (37/19028) among persons aged 65 years or older
We are still seeing a shortage of fluids on all sizes of bags. Baxter has increased their allocations, but as of today, we have still not received orders from our allocation. We receive orders once per week from Baxter and anticipate some sort of allocation order tomorrow (Thursday). Baxter has indicated what our allocations should be, but we won’t know with 100% certainty until we received them.
I don’t believe it has had an impact on patient care as of this point. We have asked our physicians and providers to determine what fluids are needed based on the patient’s needs at the time of presentation. We have temporarily halted our elective procedures that require IV fluids, prioritizing hospitalized and emergency patients. We will re-evaluate our pause on procedures next week after we see what allocations of fluids materialize.
Due to our effective conservation efforts, Allina Health resumed clinical operations at all sites across our system late last week. This does not mean the shortage of IV fluid supplies is over. Allina Health anticipates continuing to receive less than normal amounts of IV fluid resources through the end of the year. We will continue many of our conservation efforts and monitor and assess our supplies daily for the foreseeable future.
This has been an especially difficult time for some of our patients who had their surgeries or procedures impacted. We are quickly working to reschedule them in a prioritized manner and thank them for their understanding and patience. We also express our gratitude to the state and federal officials and hospital associations who continue to help us raise the urgency of the IV fluid shortage.
M Health Fairview postponed some elective surgeries last week due to the IV fluid shortage, however, as of Friday, 10/11, we we are scheduling all services as usual, including surgical cases, catheterization lab, interventional radiology, and more. We are not postponing or rescheduling any procedures.
Thanks for reaching out. I checked with our team about this and our team is not seeing any increase in Mycoplasma pneumoniae at our campuses.
At Mount Nittany Health, we are closely monitoring our supply of IV fluids and have implemented conservation measures to ensure continued availability. We have not had to postpone, delay, or cancel any procedures as of yet thanks to the diligence of our team members. We have had some of our allocations increased over the past week, but anticipate the need to sustain conservation efforts for the next few months. We will continue to work with physicians and front line staff to evaluate alternative delivery methods of these fluids, and other ways of handling clinical needs without impacting the quality of care for our patients.
Our supply is roughly the same. Full statement below.
UVA Health University Medical Center will proceed with most scheduled elective procedures through Wednesday, Oct. 16. However, given the continued constraint on irrigation fluids, the health system has partnered with surgeons to scale back procedures with high-volume irrigation fluid use. University Medical Center is reassessing the situation to determine what is feasible for the remainder of the week.
At UVA Health’s hospitals in Culpeper, Haymarket and Manassas, elective surgeries resumed Tuesday, Oct. 15.
UVA Health representatives are contacting patients if their elective surgeries need to be postponed and will continue to monitor the supply situation in the coming days. Any postponed surgeries will be rescheduled as soon as possible once the critical IV supplies become more available.
Children’s Minnesota is encouraged to see the progress made by Baxter International as it recovers from the devastating effects of Hurricane Helene. Last week, we received news that as a pediatric health system caring for vulnerable patient populations, we are among the systems that will be receiving increased allocation of product from Baxter Healthcare based on our usage between March and Aug. 2024. We have not seen the full allocation (all fluids, all sizes) yet as Baxter continues to recover from Hurricane Helene, but we are receiving some of the ordered shipments of fluids weekly and will continue to work closely with Baxter as we work through this time of shortage.
Like other health systems, Children’s Minnesota is still taking extra precautions to conserve IV fluid product because those allocations don’t take into consideration the increase in patients due to the limited supply at other systems, and the annual anticipated increase in fall patient volumes due to respiratory illness.
Some examples of conservation efforts include:
Actively assessing patients and immediately discontinuing all non-essential use of IV solutions and irrigation solutions in the ED.
Clinically evaluating each patient prior to initiating IV fluids.
Emergency departments, surgical units, intensive care units, med/surg, hospital medicine, pharmacy and other areas have very specific conservation efforts.
While we have not yet delayed any procedures, this is a serious, fast-moving situation that requires real-time decision-making. Leaders across our organization are meeting daily to monitor the situation and take action. Our patients are our number one priority and every decision we make is in service of their best possible care.
I wanted to point out that we are not cancelling all elective procedures, but some that require certain specific IV fluids. I can also let you know that we have not yet seen an increase in our regular allocation from Baxter but do expect an additional one-time shipment this week to address urgent concerns.
Statement from Mass General Brigham re: deferring certain procedures due to IV fluid shortage
As healthcare providers across the country continue to confront the national IV fluid shortage following the devastating effects of Hurricane Helene, Mass General Brigham has made the difficult decision to defer some non-emergent, elective procedures requiring certain IV fluids from Sunday, October 13, through at least Wednesday, October 16. While we strive to minimize any impact on patients, these measures will ensure we are able to care for those in immediate need. Due to the unpredictable nature of this situation, we do not know when our supply of IV fluids will improve but we are closely monitoring and will continuously evaluate to ensure we can return to normal operations as soon as possible. We are contacting affected patients and will work to reschedule them as soon as we are able.
“At this time, VA has not identified any procedure cancelations as a result of this shortage. VA is closely tracking inventory, shipments, cross-leveling supply between facilities when appropriate, and following general conservation guidance to maximum use of existing supplies. We will continue to take all necessary actions to serve Veterans, maintain continuity of care, and ensure patient safety.”
“Ensuring people have medical supplies they need is a top priority of the Administration. It’s exactly why we are working closely with Baxter to support cleanup and restoration of the facility, including invoking the Defense Production Act to help production resume as quickly as possible. The Administration also moved quickly to open up imports from five facilities around the world and make it easier for hospitals to produce their own IV fluid during the shortage. As a result of these actions, 50% more IV fluid is available now compared to right after the hurricane. HHS is using all necessary authorities to bolster supply and mitigate impact to patients over the coming weeks.”
Main Line Health continues to experience a shortage of IV fluids. Despite maximizing our conservation strategies, unless supplies arrive, we may be forced shortly to cancel some elective surgeries. Although Baxter has increased allocations of some fluids, it has further restricted others. One-liter bags of 0.9% saline — our most commonly used fluids — are on back order, with no shipments expected for at least 3½ weeks. If so and alternate supplies cannot be obtained, we may have to curtail other services.
Because Mount Sinai uses a Baxter competitor for IV fluids, we are not as affected as others. With that being said, our supply team has been having regular conversations with our vendor to discuss the allocations that have been placed to ensure there is not a run on product. Mount Sinai has also been preparing for these types of situations by having safety stock set aside.
We have not cancelled or postponed any surgeries or procedures.
We are closely monitoring this situation and have been implementing conservation strategies while continuing to care for all patients. All patient needs are being met.
We just added three new parenteral drug products to the drug shortages database. The FDA now considers Dextrose 70% IV solution, Lactated Ringers IV solution, and Peritoneal Dialysis solution to not be commercially available in adequate supply to meet national demand.
You’ll have to ask Baxter regarding the second point. And the importations are from Baxter’s facilities.
You’re obviously already keeping an eye on our website, but please continue to do so! We’ll post updates there: https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina
Quesiton [00:23:00]
Our first question is why are these sodium reduction goals voluntary and not mandatory?
Robin McKinnon, FDA [00:23:09]
I can take that one, Janesia.
So at this time, we’re not exploring mandatory sodium targets. We’re focused on the implementation of the voluntary targets.
Currently, we believe that a voluntary, iterative approach is the most effective and appropriate approach. And we’re pleased to be seeing some initial progress already.
Voluntary targets for a broad array of food categories have shown success in other parts of the world, as I mentioned in Canada and the United Kingdom. So this is a reasonable approach for now.
We think that the real value lies in allowing both the FDA and the food industry to have a common system for defining and measuring progress in reducing sodium in the food supply. And we’ll certainly continue to engage with industry to learn about their successes, potential challenges in achieving the targets.
As palates adjust to lower sodium a company’s product could taste overly salty by comparison. So we certainly encourage all industry groups to work towards the targets.
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Lauren Zhovmer, FDA [00:30:16]
Our analysis of the food supply using the 2022 data is, again, it’s preliminary. We don’t know yet the full extent of the progress towards the phase one goals, but regarding the preliminary analysis, there’s various reasons why we might see some categories increase in sodium.
There’s– this mainly includes shifting sales at the top sellers, which may have been reformulated with lower sodium or even higher sodium, there’s new product introductions into the category, or even discontinuations of products. And also just the availability of data to us for the category.
These can all impact measured category levels.
Our Daytona Beach IV solutions manufacturing site and distribution center were not seriously impacted by Hurricane Milton and will resume operations as planned on Friday morning, October 11. We understand from discussions with employees that there have been no reported injuries, but many are still without power. We are especially thankful to the employees who remained at the site to provide updates throughout the storm.
To safeguard the supply of finished products, we worked closely with the federal government, specifically the Administration for Strategic Preparedness and Response (ASPR), to leverage their resources which allowed us to move more than 60 truckloads of IV solutions inventory from our Daytona Beach distribution center to a secure, temperature-controlled facility, north of Florida. The product will now be returned to our distribution site.
We are in daily contact with officials from ASPR, the Drug Shortage staff at CDER (Center for Drug Evaluation and Research) and the Department of Health and Human Services to address this issue and help alleviate any impact on patient care.
As of 9PM last night, 60 truckloads of product were shipped from B. Braun’s distribution center in Daytona Beach. They contained a total of 1,400 pallets and 70,000 cases of product.
The monograph forecast is a nonbinding document and does not mean with certainty that the FDA will propose action within the next three years; however, it does reflect what the FDA is currently considering a priority over the next three years.
A proposed order addressing the generally recognized as safe and effective (GRASE) status of codeine and related salts as antitussive active ingredients is currently listed on the monograph forecast. Codeine, codeine phosphate, and codeine sulfate, when used in combination with other cough-cold active ingredients, are currently considered GRASE when they are (1) indicated for OTC use as antitussives in adults and children 6 years of age and older and (2) marketed consistent with all applicable antitussive monograph conditions and other applicable requirements. With respect to whether the concern is safety or effectiveness, both can be intertwined and the FDA is re-evaluating the GRASE status in light of the risks associated with codeine-containing cough medicines.
The proposed order to address the GRASE status of OTC phenylephrine as an oral decongestant is also listed on the monograph forecast. Oral phenylephrine is currently considered GRASE for use as a nasal decongestant in adults and children ages 2 years of age and older. In September 2023, FDA held a Non-prescription Drug Advisory Committee meeting to discuss the effectiveness of oral phenylephrine as an active ingredient in OTC cough-cold products that are indicated for the temporary relief of congestion, both as a single ingredient product and in combination with other ingredients. The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. Please read the CDER Statement for more information about the results and next steps related to the FDA’s advisory committee meeting on the GRASE status of oral phenylephrine in nasal decongestant drug products.
Today the Biden-Harris Administration is announcing a plan to begin public health entry screening at three U.S. airports for people coming from the Republic of Rwanda to reduce the risk of importation of Marburg virus disease (Marburg) into the United States. Starting mid October, airline passengers who have been in Rwanda in the last 21 days will have their travel to the United States rerouted to Chicago (ORD), New York (JFK), and Washington DC (IAD) where these travelers will undergo public health entry screening upon arrival.
Currently, Rwanda is experiencing an outbreak of Marburg, a rare, severe viral hemorrhagic fever similar to Ebola. The risk of Marburg in the U.S. remains low, however, these measures are being taken out of an abundance of caution given the ongoing outbreak in Rwanda.
Dawn O’Connell, ASPR [00:31:02]
One of the concerns we have at ASPR is on the medical health supply chain.
As soon as we heard that there was a situation, with the Baxter plant in Marion, we reached out and spoke to the CEO Saturday night. We had our teams meeting for the first time Sunday morning, and we’ve been meeting daily since then.
I think folks know Baxter, has been– they provide 60% of the nation’s IV fluids and we are working to, and they are working and have been a terrific partner in trying to find additional supply.
They have fortunately plants across the world that they are looking to access supply from and bring in to be able to staunch which is the difficulty right now for them of being able to access their plant.
There was a bridge that went out and that was the bridge that would bring things back and forth.
They’ve been able to for their industry, they’ve invested in this, on their own, put a rock bridge in to begin to get some of the machines in to help augment and begin to clean up and get it back online. They also had some supply in their plant that they thought was salvageable. They’re looking at that to try to get that into the supply chain.
But from the federal perspective, we’ve been in lockstep with them helping to secure whatever bridge access they needed, and also to look around for additional suppliers who could fill the gap while they begin to ramp back up.
But I will say, it’s a concern of ours, but Baxter’s been a wonderful partner in trying to minimize the impact on the supply chain.
Of course, we saw the east coast port situation get resolved overnight. That was an additional pinch that we were worried about.
But that’s now less of a concern and we’re focused on getting Baxter back up and ready to go. And they’ve been a terrific partner in all of us and are very concerned about this as well, but we continue to meet regularly to assist.
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Andrea Palm, HHS [00:32:59]
I would just say to that end, the Food and Drug Administration, also a member of the HHS family of agencies, and as Dawn noted, there are a couple of other domestic manufacturers for some of these products.
And we through our colleagues at FDA are in touch with those manufacturers about the opportunity for them to ramp up as Baxter is getting itself square and assessing their situation and getting back online and back up to full capacity.
But we’re again, pulling all the levers we have at HHS to make sure we’re leaning in to support this work more broadly, including our colleagues at FDA.
Robert Califf, FDA [00:18:29]
It turns out, a huge part of my time has been taken up, including today, on very basic supply chain issues across every commodity that we regulate in an increasingly complex global, inter-digitated supply chain consumed by just in time low inventory thinking to reduce cost.
We are seeing shortages and supply chain interruptions, often due to climate change or international strife.
And it’s a very combustible mix.
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Robert Califf, FDA [00:27:21]
If you look underneath it all, whenever you say government agencies, there’s a negative reaction by a large part of our society.
Unfortunately, a lot of that’s driven by politics and the cultural divide, very hard to deal with.
But if you look at people’s individual interactions with people that work in these spheres, they’re not so negative.
And I think you see that right now, going on with Helene, if you’re on the ground in the Asheville area, there’s a lot of good collaboration and hard work going on.
And yet still, if you ask the question is government response adequate, it would break down according to political lines.
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Robert Califf, FDA [00:43:13]
We have hundreds of shortages of drugs, and there’s an inverse relationship between the price of the drug and the probability of a shortage with the one exception of the weight loss drugs, which I won’t talk about. That’s a whole different set of issues.
And what’s happened, it’s been called a race to the bottom, as generic drugs, over 90% of our prescriptions have become commoditized, the price has gotten so low that you can’t afford to make them and distribute them with U.S. labor costs at the current price.
And unfortunately, in my view, the purchasers driven by our own U.S. health systems are so interested in the lowest price, they don’t build resilience criteria into the contracting. And so, this is a real mess.
And something that’s talked about a lot less is that on the device side, the very low cost devices, syringes, stop cocks, we’re down to one syringe maker now in the U.S., it’s all– and PPE, you remember when there was all the upset about gowns and gloves and masks, that’s all moved back to China now.
So, we’re working, uh, with Congress to try to get fixes to the system that would require resilience as part of the effort and bring back.
We don’t need it all manufactured in the U.S., but we need enough in the U.S. and so-called friend-shored that we’re not susceptible to these lapses that occur, that create real hardship in problems in the clinical care community.
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Robert Califf, FDA [00:45:01]
In the meanwhile we have a huge effort every day and we’re doing it right now with regard to basic normal.
Who would have thought we wouldn’t have enough normal saline and Ringer’s lactate for the country?
They were already in shortage. And now this plant went down in Asheville, due the hurricane.
So in the meanwhile, we try to fix it up without having access to the data we need, because that’s been blocked.
But, you know, so far we’re mostly getting by okay. But as you point out, I think it’s a tremendous amount of hardship that could be averted.
As part of ASPR’s preparedness mission, the agency has invested approximately $365 million dollars into medical countermeasures - a vaccine and antibody treatment - for filoviruses, such as Marburg.
We have invested over $235 million into the development of Sabin’s ChAd3-based filovirus vaccines that target Marburg virus and Sudan ebolavirus.
Another $129 million has been invested into the development of Mapp Biopharmaceutical’s MBP-091 monoclonal antibody for treatment of infected individuals.
These investments, coupled with ASPR’s expertise, have advanced the two countermeasures through preclinical safety and efficacy and Phase I clinical trials.
Doses of the ChAd3-SUDV were shipped to Uganda in preparation for a ring vaccination study just prior to the end of the latest Sudan ebolavirus outbreak and both ChAd3-SUDV and ChAd3-MARV are currently in Phase 2 trials in Uganda and Kenya.
In partnership with the Rwanda Ministry of Health and international colleagues, ASPR has made an initial quantity of MBP-091 and ChAd3-MARV available in Rwanda to enable patient treatment and vaccination of contacts and healthcare workers.
Those investigational therapeutics and vaccines will be used under clinical trial protocols approved by Rwandan Regulatory and Ethics Authorities.
Nirav Shah, CDC [00:06:24]
Both individuals are dairy workers at two different dairy farms in California, both of which again are known to have cows that have tested positive.
The state of California in conjunction with their local county health departments have been conducting active symptom monitoring of exposed workers on these farms. As a reminder, this is the process whereby individuals or farm owners report any symptoms, and then are followed up by public health officials at the state or the county level for things like testing, therapeutics, etc.
Health officials in California identified both of these cases through that process. Both individuals experienced mild symptoms, including conjunctivitis and neither reported respiratory symptoms. Neither individual was hospitalized. One individual reported that they thought that they might have had a fever.
Both individuals were tested, offered antiviral treatment and are recovering. California is following up with potential close contacts.
We are aware of household contacts who are also dairy workers and who have been contacted by county public health departments, or who will be contacted today. Thus, the public health investigation is very much underway at this time.
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Demetre Daskalakis, CDC [00:17:46]
Serology is one tool public health leverages when we identify close contacts retrospectively, when they no longer have respiratory symptoms.
A flu serology test is done by drawing blood or sticking a patient’s finger for a blood sample.
Although some commercial laboratories can test for seasonal influenza A or B antibodies, there is rarely a clinical reason to conduct such testing.
Antibody tests for H5 are not commercially available. The CDC laboratory is an influenza WHO collaborating center and can perform serology testing of novel flu viruses in its BSL-3 labs. And we do this routinely.
This test is not like other clinical serologies, which is a test a clinician would order for HIV or hepatitis B or C. It’s a research test we use for surveillance that provides supportive evidence that someone was or was not infected with H5.
Testing for an H5 antibody is more complex than the clinical serology that I listed above, requiring both the appropriate viruses needed to detect specific antibodies, and in many cases, high containment laboratories to perform the testing because the methods require working with infectious viruses.
That means that it may take an additional two weeks for us to report the result of the seven serology specimens obtained from individuals in Missouri.
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Demetre Daskalakis, CDC [00:19:10]
I will briefly walk you through the steps that CDC is taking to test these samples.
As we previously reported, CDC was able to perform partial sequencing of the avian influenza H5 virus from the case in Missouri, despite a nearly undetectable level of viral RNA in the patient sample.
This showed that the virus had two potentially important mutations, meaning two amino acid differences, in comparison with the virus is previously characterized during this event that could affectantigenicity.
Antigenicity is a property of being able to induce a specific immune response, such as creation of specific antibodies. So for serology testing, to be conclusive, it needs to be done using a virus that is genetically identical to the one obtained from the human case from Missouri or else there is a risk of a false negative test.
Since this H5 virus was not recoverable, we could not grow it because there was not enough from the Missouri specimen, CDC needed to create the right virus for the test using reverse genetics to match the one from Missouri so that we can use it in these serology tests.
This requires additional time and involves multiple steps.
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Demetre Daskalakis, CDC [00:20:26]
So we’ve been working on this since we sequenced the virus from the Missouri patient in mid-September.
It took about three weeks, to rescue the Missouri virus using reverse genetics, and complete the quality control steps that ensure we have the right virus.
This process will conclude by Monday and serology testing on the samples will begin.
At this point in time, CDC expects that conclusive serology testing results will be available in mid to late October.
We realize people including all of us at CDC are anxious to see results from this testing. CDC is moving at a very accelerated pace while conducting rigorous science to assure the validity of these results.
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Eric Deeble, USDA [00:22:59]
USDA has confirmed that the virus present in California is the B3.13 strain that was detected in the first three affected California premises and has been detected in dairy herds in other states.
This is the same virus that we’ve been detecting in herd since the very beginning of the emergence of H5N1 in dairy cows back in March.
CDFA has been conducting a very thorough trace back, and the initial cluster of detections, that were noted, were found through this trace back activity.
Subsequently, CDFA has established a 10 kilometer zone around each of the affected dairies and begun testing bulk milk at the dairies in those zones, every week, for H5N1.
This bulk milk tank sampling has been the source of all of the recent detections that we’ve seen out of California.
CDFA is also evaluating additional strategies for milk, collecting milk samples from unaffected areas that are not located in the surveillance zone, which may include utilizing state, federal regulatory animal health personnel, county, or state milk inspectors, or milk processors to give them a more comprehensive picture of the emergence of H5N1 in California.
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Eric Deeble, USDA [00:25:54]
As many of you may be aware, the state initiated a mandatory bulk milk testing program, in an effort to clear the virus from Colorado in July 2024, (inaudible) and it has proven to be very successful.
The state’s surveillance was in response to ongoing detections, in individual premise. Initially this revealed a significant local prevalence about 72% of dairies, centered in Weld county.
Colorado has seen excellent compliance with the mandatory bulk milk testing. And right now we can report that there is only one positive herd, out of the state total of 86 herds that is currently affected by H5N1.
Mandatory surveillance in the state allows for continuous monitoring of herds and helps to detect any instances of non-negative results early on ensuring timely intervention.
This decrease in the Colorado cases, even in the absence of a vaccine, gives us further confidence that H5N1 can be eliminated in the national herd, even in states where we have seen an initial rapid increase in cases.
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Steve Grube, FDA [00:32:19]
Foremost, we wanted to address concerns from dairy producers that commercial milk processors might reject milk from dairy premises identified as having or possibly having H5N1 infections in their herds.
We have received no reports that this has happened anywhere. But we wanted to emphasize that there’s no reason for it to happen.
Left unaddressed, that concern could discourage robust participation in voluntary surveillance and sampling programs, which are critical to expand knowledge of the disease and inform programs to reduce H5N1 circulation.
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Demetre Daskalakis, CDC [00:48:09]
There have been extensive questionnaires that were conducted with this individual, and they included, sort of a review of food exposure.
So again, no raw milk exposure.
The individual did report using dairy and eating dairy, but we don’t have anything that would implicate an immediate dairy exposure.
Certainly not raw given the fact that they reported no raw milk exposure, but nothing that sort of directly implicates the dairy exposure at all.
Again, I think it’s fair to say that we, despite a lot of work on Missouri’s part, supported by us, in thorough investigation through survey, we have not been able to detect an animal or animal product exposure, based on that on those conversations.
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Eric Deeble, USDA [00:55:19]
I actually don’t think that it is out of place.
In those states that have had a really robust response and begun bulk milk testing very rapidly, I’d point to Colorado and Michigan in particular.
We’ve seen a very rapid phase of initial detections, and a subsequent diminishment over time, sort of a long tail as the disease is eliminated from herds within the region.
I think what we’re doing now is seeing that very steep initial run up in detections caused by the state’s very thorough testing program.
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Steve Grube, FDA [00:56:32]
So as soon as we heard about this case, we worked with our state co-regulatory partners to identify any potential pasteurization failures in any state that supplied milk for Missouri and working with our partners, we found that there were no pasteurization failures in a recent timeframe, where it might be a reason for this person to be exposed.
Again, there were no pasteurization failures in any states that were supplying dairy products to Missouri.
And in addition, the amount of virus killed by pasteurization provides a many log order of magnitude safety barrier, safety margin, that ensures that the milk supply remains safe.
Eric Deeble, USDA [00:17:35]
We are wrapping up now the third round of experiments in BSL 3 facilities, in order to help us better understand how this disease manifests in animals, and how we can address it.
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Eric Deeble, USDA [00:17:59]
I will mention that we are also sampling beef that is derived from culled dairy cows, through our national residue monitoring program, to make sure that we have as much visibility into H5N1 in the herd as possible.
To date, we have detected no H5N1 in these samples, but out of an abundance of concern, both for public health, public safety, trading relationships and opportunities, we’re going to continue to do this for the foreseeable future.
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Eric Deeble, USDA [00:18:41]
A couple of things that folks often are interested in is the way in which this disease has spread and whether or not say the fall migration and birds moving back through the environment pose a risk to dairy cattle in the same way that they do to avian flock, typically poultry houses.
And the answer is no. We have quite definitive evidence that H5N1 is spreading between states through cattle movement, which I mentioned earlier, and then spread between dairies, and sometimes, within dairies and sometimes to other dairies through the movements of individuals and equipment.
We don’t know everything that we would like to about this disease, and we’re continuing to study it as vigorously as we can. We’re particularly interested at this point at the manner in which the disease is transmitted from individual cow to individual. We know that it is not respiratory. We do know that it is associated with milk. We believe that milking equipment, and other environmental surfaces or milking practices are implicated, but it is challenging to get the definitive answer that we want, even as we continue to explore that we do know the best way to address that.
And that is to make sure that folks understand the risk to their herd, and are able to implement biosecurity, in order to mitigate the risk of the spread.
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Lizette Durand, CDC [00:39:30]
CDC is also collaborating with state health departments on H5N1 seroprevalence studies to determine if there is asymptomatic infection among people who have worked with sick cows.
Sero prevalence studies can help to answer important public health questions about whether there is evidence of asymptomatic infections and what behaviors are associated with greater or lower risk to infection.
The Michigan health department released negative results from first round of data collection last month, additional data collection is ongoing.
Colorado has completed enrollment in their study, and CDC is testing specimens in our lab.
Additionally, a CDC team of epidemiologists, veterinarians and health communications specialists worked with the Ohio department of health to conduct a serosurvey that will assess past exposures to H5 viruses among a national network of veterinarians and other veterinary professionals. Next slide, please.
As I mentioned on the previous slide, CDC collaborated with the Ohio department of health at the American Association of Bovine Practitioners or AABP annual conference to conduct a sero survey.
The study enroll at about 150 attendees who have worked closely with cattle in the past three months.
As DSM has publicly indicated, it has submitted an OMOR for bemotrizinol to the FDA. In general, after an OTC Monograph Order Request (OMOR) is submitted, the FDA will determine if the OMOR is acceptable for filing. If the FDA accepts the OMOR for filing, the FDA will review the OMOR. The FDA would then typically issue a proposed order addressing the substance of the OMOR within a timeframe agreed to under the OMUFA Goals Document. The public will have a minimum of 45 calendar days to submit comments on the proposed order (although FDA may provide for a longer comment period). After reviewing and considering the comments, the FDA would issue a final order, including to update the relevant OTC monograph(s), if appropriate.
The FDA continues to encourage industry to submit data to address the data gaps for those monograph ingredients FDA has indicated need additional data. This will enable the FDA to confirm the ‘generally recognized as safe and effective’ status of these ingredients.