THE NATIONAL ANTIMICROBIAL
RESISTANCE MONITORING SYSTEMS MEETING
June 24, 2005
I N D E X PAGE
NARMS International Activities Discussion Comments
by Patrick McDermott, Ph.D.
by Tom Chiller, M.D., M.P.H.
by Shaohua Zhao, D.V.M., Ph.D.
NARMS Funding Comments
by Stephen Sundlof, D.V.M., Ph.D.
Panelist Comments on Questions Posed by NARMS
by Linda Youngman, Ph.D., Moderator
Panelist Comments:
Question One
Question Two
Question Three
Question Four
Question Five
Question Six
Keynote: “---“ indicates inaudible in the transcript.
M O R N I N G S E S S I O N
(8:34 a.m.)
Recap
by Linda Youngman, Ph.D., Moderator
We then turned to the retail meat sampling. Terry Proescholdt gave a talk about the sampling strategy and how we switched from a convenience sampling to a random sampling. Elvira Hall-Robinson then spoke about the NARMS annual reports, how we are reporting data, how we are trying to work toward the three arms reporting in a similar fashion so that data from the three arms can be used and compared directly.
And, finally, we finished with Shaohua Zhao, who talked about the molecular characterization in PulseNet and what we can do with the information from PulseNet that can help guide us toward looking at associations between animal-human outbreaks, that sort of thing.
Today, we are going to be talking about international/national issues. And, Pat McDermott and Tom Chiller are both going to be talking today about some of the international activities that NARMS is involved with in particular. The WHO Global Salm-Surv activities where we provided funding and training around the world.
Dr. Sundlof is going to talk a little bit about funding. And then, after the break, we are going to spend time going through the six questions, hearing from each of the panelists. And, again, we aim to finish by 11:30, 12:00 today.
Just a reminder, to help our transcriber who has been working very hard trying to keep up with all of the comments, we have moved the microphone to the center of the room. It is helpful when she is doing the transcribing if you speak directly into the microphone rather than from your seat.
So without further ado, I am going to turn it over to Dr. Pat McDermott, and then Dr. Tom Chiller, who are going to talk about NARMS international activities.
NARMS International Activities
Comments
by Pat McDermott, Ph.D.
DR. MCDERMOTT: Thank you, Linda. What we will do first is I will talk a little bit about international surveillance supported by NARMS, Tom is going to make a few points about other national surveillance programs that interact with NARMS, and then Shaohua will talk about PulseNet International. So there is really three of us that are going to contribute to this topic today. It probably would be best if you have questions, to wait until we have all presented. That might make it go more smoothly.
NARMS programs supports the work of international organizations involved in foodborne disease surveillance and monitoring. We do it in a number of different ways; we are really going to focus on three points: The WHO Global Salm-Surv; Tom will talk about interactions between NARMS and other national surveillance networks; and then Shaohua on PulseNet International. I mentioned the training of scientists in this slide, only because I know that all three laboratories (CDC, USC, FDA) have been involved in the past, or are currently involved, in training scientists from around the world who are interested in the same sort of programs that we put together in NARMS. So, Paula mentioned interacting with CIPARS and also supporting the Mexican Resistvet Project by training their scientists. We currently have two visiting scientists from the People’s Republic of China who are trying to do what we are doing in NARMS; that is, to include in their surveillance animal isolates and food isolates. So they are in our labs for most of the summer, working with our scientists. So I consider that part of our international activities because we at least have the reputation that inspires people to come and seek our expertise, whether at USC, CDC, or at FDA.
(Slide)
I am going to address one important way in which we are involved with international activities. And Dr. Walker had this mentioned in his slides on the budget that FDA-CVM contributes financial and technical support to this program, the WHO Global Salm-Surv.
The WHO Global Salm-Surv mission is to build capacity in foodborne disease surveillance and response.
(Slide)
What I want to emphasize, at the outset, is it is not a program which WHO intends to run indefinitely. The goal is to help countries build that capacity for themselves to take over, ultimately, the financial responsibility, garner the political support, train scientists in the area in lab-based surveillance and in outbreak response.
(Slide)
The steering committee, in addition to FDA-CVM, Centers for Disease Control and Prevention -- and I would be remiss if I didn’t applaud Dr. Angulo who has really spearheaded much of the work this program has done, and has seen it grow from one training course in Thailand to now really a global organization.
Institut Pasteur is on the steering committee; the Danish Institute for Food and Veterinary Research. You can see Public Health Agency Canada in the Netherlands; and Lelystad, the Animal Sciences Group; the Australian Surveillance Group; and then Enter-Net, which Tom may talk about, which is a European surveillance network.
(Slide)
The goals are: to strengthen capacities of national public health institutions; establish regional centers for specialized training; and to expand to new areas of need -- so this is a level at which, through the regional centers, we hope to turn over responsibility for building on the initial training and coordination provided by WHO to regional centers. I will say a little bit more about that. Another goal is to foster collaboration among microbiologists and epidemiologists. We all struggle to do that more effectively. It is considered, in some cases, a major barrier to really fully integrate a mature system, that is to keep those channels of communication open.
(Slide)
The other goals -- of course, these all look familiar to us in NARMS – are to advocate for financial and national support, to foster global communication; and to improve quality and reporting of national data.
(Slide)
This shows members, or member institutions, around the world. There is now more than 800 such members around the world. It has really become a worldwide organization.
(Slide)
And the activities, the way WHO-GSS seeks to meet its mission statement and the goals of the program, one of the main ways, and one of the ones which requires a lot of the financial support, is to conduct international training courses. Courses are setup in regions, and multiple countries send representatives to participate and to learn the laboratory methods and the epidemiology methods.
Another major activity is to develop the regional center so they can pick up the responsibility for promoting the program and maintaining, sustaining, if you will, the program. We do have an external quality assurance system which also some of the NARM sites participate in, in which Salmonella are sent out to the participating institutions for serotyping and susceptibility testing.
We also send campylobacter isolates out for speciation. Susceptibility testing of Campylobacter may be forthcoming.
There is a list-serv and electronic discussion group. A country data-bank in which the countries who have received training are required as part of that training to provide information on the top Salmonella serotypes in their regions or countries.
Because there are region-specific foodborne illness issues, focused regional and national projects often come out of this training and are encouraged; and, coordinated in some cases by the regional centers. These centers are also required to provide reference testing.
(Slide)
International training courses are done in multiple cycles and there are different levels of training. Some members, some laboratories, some institutions have some experience but are interested in learning more and expanding their surveillance capacity. Other places have no experience, essentially. And so, depending on the needs of the nation, and the experience of the members, and the participating laboratories, we will try to adjust and customize the training to best suit their needs.
In general, about 10 countries attend each training course, although it varies somewhat. We try to go back to that same training center within a reasonable amount of time, 12-18 months. Because in that process, what is done in the previous training course is sort of reinforced and repeated, and then other more advanced courses are introduced at that time.
And again, the goal is to bring together microbiologists from the human, veterinary and food disciplines. So, just like we are doing in NARMS, we are trying to encourage the same sort of WHO recommended three-part approach to surveillance.
So we bring together microbiologists and epidemiologists in this course work. It is to develop -- as it notes in the final bullet -- practical skills; the importance of communication and interaction between the disciplines; platforms for communication, a critical element; and we ask them to participate in providing future plans for their countries. So now that you have this training, what can you do with it. Show us, give us some evidence, give us a plan on how you are going to implement it. What you can do in terms of communication and training others within your area in gaining political support, and so on.
(Slide)
So the courses are both microbiology, largely bacteriology, and then an integration of that with the epidemiologists. So it is hands-on teaching, lectures, and exercises. Usually, in the basic course, it begins in focusing on one pathogen, Salmonella. And then in subsequent advanced courses, more sophisticated methods, and additional pathogens are added to the surveillance, and so on.
We spend a lot of effort teaching them proper methods for susceptibility testing. And then when we bring the micro. and epi. groups together, we review the micro-course so the epidemiologists can get an understanding of what goes on in the laboratory-based side of it. And the laboratory people meet the epidemiologists, so they can basically understand each other and use the information from both disciplines to do their capacity building.
In these integrated courses, we have small group discussions with lectures and exercises where they do simulated outbreak investigations and things of that nature. And then also at these meetings, we request a joint country plan of action by the microbiologists and epidemiologists. So there is always this push to show that the training has benefitted you and that the support WHO and the program has provided, you are actually going to implement. Because we don’t want to go back to a country where, either through lack of political support, or just an inability to generate interest, that the training isn’t really put into use.
(Slide)
This shows places around the globe where the training sites are and also the regional centers. You can see there are four regional centers. And at the time of this slide, anyway, I think it has changed a little bit, over 90 countries have participated. There are new proposed training sites in different parts of the world. We are trying to do our best to provide training in areas where we can get the most attendance and the best bang for the buck, if you will.
(Slide)
We don’t just give them the information then and cut them loose, so-to-speak. So we do ask for them also to tell us how we can do the job better on a regional basis. Because as I mentioned, some areas have different needs and different experiences than others. So we ask them to evaluate the training course, and CDC’s developed this type of evaluation form; which is a fairly recent addition. I mentioned the external quality assurance system to help also measure the impact of the training. And also, the regional and national projects, which can come out of the training.
(Slide)
Some of this I mentioned, I really have this slide up here so that you can see the website. There is an English and Spanish version on the website if you want to learn more details. It wasn’t my intention to do more than just give a general overview today, but it is an excellent program that, I think, has done a lot on a shoestring often. So it is something that FDA-CVM has seen as valuable in its public health protection function of GSS.
(Slide)
I want to say just a few things about another project that CVM has supported in the international arena, and I should say USDA also. And that is the Resistvet Project in Mexico.
Again, Mexico expressed an interest in trying to set up an national surveillance system modeled on NARMS. So we provided expertise again and financial support to help them develop this. Paula was instrumental in getting this off the ground, along with Dr. Tollefson and Marsha Headrick.
We have participated as advisors, generally, in training and in some collaborative research projects.
(Slide)
This shows the states that are participating in the Mexican surveillance system. There are four states that have been included in, really, what is a pilot attempt to get this off the ground.
(Slide)
They are looking at healthy and ill humans. They look at all intestinal and extra intestinal isolates from one hospital and two primary care centers within each of the regions --states, if you will. They also look at healthy, asymptomatic children in kindergartens and also food-animal products. And it shows you here that they go out and collect poultry and pork at the supermarkets in the same area where the asymptomatic children are sampled.
(Slide)
As far as moving to slaughter houses, that has been a major challenge in this project. Getting the political support, getting the producers and local authorities to grant that access. Dr. Zadi, who runs a program in Mexico, has had some success in this arena. So there is more support, I think, to have access to the slaughter houses. And, of course, some you don’t know where they are. I thought to bring some pictures of Mexican slaughter houses, it is quite a bit different than the U.S. system.
(Slide)
And then we can all be familiar with these points. They have met major obstacles trying to get this off the ground. Recruiting, training, and retaining personnel in the laboratories. They had some problem early on with campylobacter isolation, which they resolved; and campylobacter susceptibility testing which, hopefully, will be resolved by the availability of the broth method.
So that is all I wanted to say. I just wanted to give that information to you to just, basically, tabulate it for you without showing you the data -- which there is a lot from WHO Global Salm-Surv. And you can get an idea of that from the website.
I am going to let Tom take the podium now and talk about other collaborations between NARMS and other national surveillances.
Comments
by Tom Chiller, M.D., M.P.H.
DR. CHILLER: Thanks, Pat. Thanks. And I am just going to talk for about three or four minutes. And building on what Pat talked about we, obviously, at CDC do a lot of work with WHO Global Salm-Surv and, I think, have enjoyed tremendous success internationally. And have learned a lot and have partnered with a lot of people.
One of the things Global Salm-Surv does is it introduces you to many people at these training courses that are working in these diseases, working in surveillance, from all these different disciplines, as Pat mentioned. You learn things about them, you learn some of their needs, and you also get -- as with any training course, there is some people that sort of rise to the top because of their enthusiasm. Potentially, their financial support.
And those people, many times we end up partnering with further because they are very enthused and they might have to find local resources to do something else. And we are clearly trying to help these groups where we can in our own busy schedules move forward in different arenas.
And one of those arenas has, obviously, been in antimicrobial resistance surveillance. And so what I am going to talk about is the concept that we have been throwing around now for about a year and a half. And that is to form some sort of international collaborative working group. I don’t want to call it a network, we have too many networks in the world of health right now. So I look at it more as an international collaboration of people working in antimicrobial resistance surveillance; specifically, for enteric bacteria.
Because as we have all been hearing about yesterday, there are some very unique issues to enteric bacteria that are quite different from pneumococci and meningococci, and other things that we do look for resistance in in human health.
(Slide)
I just want to say the international work, just to make two points -- you guys have all heard these points before but, obviously, diseases have no national borders, as we all know. And that is a big, big reason that we are involved in emerging diseases and why we at the CEC are all over the world working on understanding how diseases emerge. And, of course, within that is how antimicrobial resistance emerges and disseminates around the world.
And in food safety, which we are all involved in by default now, is working with enteric pathogens -- I mean, that is a huge international issue and huge trade issue. And there is more and more support worldwide for doing good surveillance as a cornerstone and key to any food safety program. Even the Food and Agricultural Organization, FAO, has put as one of their core principles foodborne disease surveillance.
And so WHO Global Salm-Surv, we are approaching them and, hopefully, we will be working more with FAO to help build capacity for this foodborne disease surveillance around the world.
(Slide)
This is the map that Pat just showed, and I just re-show it to say that you can see that we are working all over the place. And, again, because of these various training courses, we have been able to meet partners and find people that are very enthused to move forward with their resistance surveillance work and foodborne disease surveillance work.
(Slide)
One of the things that has happened as a result of Global Salm-Surv is the formation of an international collaboration of burden of illness studies. As you know, FoodNet -- well, you don’t know -- but FoodNet, essentially, is done to try to understand the burden of illness because it is able to calculate a distinct number of disease within a distinct population. You have numerator and denominator data.
And then you are able to go out and survey the population, survey the hospitals and clinics and understand that pyramid of surveillance that I showed you. Understand what the different steps are and so you are able to calculate a burden of disease, using these sort of principles we have been able to estimate.
You know, there is one point -- you all heard the number, 76 million foodborne disease. All that kind of stuff. That is all based on estimations by building this pyramid. Well, other groups around the world and WHO has been pushing to understand the burden of foodborne diseases in parts of the world. Or, the ideal would be all over the world but that is, obviously, very difficult with 300 and some countries.
So building out of Global Salm-Surv training and the contacts we made, we formed a group called the International Collaboration of Burden of Illness Studies. Which is, essentially, a working group and there are now over 30 countries that are represented that are interested in conducting studies. This group has quarterly conference calls where you will get upwards of 30 countries represented.
They discuss protocols for doing these studies, they discuss results of studies, and discuss ways in which to analyze the studies and problems. They, actually, have had an annual meeting now for the second time. It happened this year in collaboration with the Enternet meeting -- and I will talk about Enternet in a second. Enternet is a European collaborative surveillance effort for foodborne diseases. And then they have even had some site visits to countries that want to start burden of illness studies, so have been able to provide support.
So this network, or this collaborative group, has been able to get together and talk and find a country that wants to do something. And they have been able to find people nearby that have experience in conducting these studies to actually go over and support the country that wants to begin one.
(Slide)
So in a similar sort of parallel fashion, we have been thinking about this idea for antimicrobial resistance. And we have done -- and Pat and Paula will point out the collaborative work with Mexico that they have been heavily involved in -- we have not -- but we have been involved in a lot of other places, and I am just listing a bunch here just to give you some ideas about the different things that we are involved in.
There is a lot of resistant Salmonella and Shigella out there, and we are involved in a lot of different country-specific projects to try to understand the movement of that Salmonella; both in the country and to our country, and to other countries for quinolone resistant Salmonella in the Phillippines. We have our share here now. Fiji, that we just heard of naladixic acid resistant Typhi. Nalidixic acid resistant Typhi is also not responsive clinically to Cipro, so that is a problem. It hasn’t been reported in the Pacific yet, but it looks like it is there.
Argentina has been very instrumental in a antimicrobial resistance network within the southern cone and within South America. We are very involved with them. Peru sent me a proposal two weeks ago to actually start their own NARMS. That sort of was out of the blue, and through discussions we have been having for the last couple of years, so that is sort of interesting.
I haven’t had a chance to read it yet, but there is, obviously, movement down there in South America. Similarly, Paraguay is trying to do something with PAHO on a pilot project to look at agricultural use of antibiotics.
We do a lot of work in Kenya. There is a lot of MDR Salmonella and Shigella there. Australia, we have worked with colleagues there and they, actually, have just found that their campylobacter, which is not resistant to floro-quinolones, but it looks like there is a budding resistance to macrolites. It is very interesting.
Bangladesh, incredibly resistant Shigella. Enternet, as we know, that is the European system that Pat mentioned that we work with. This represents all EU countries, so it used to be 17, now it is something like 27, 28. They meet once a year, but they also have a very good collaboration throughout the year in outbreaks of Salmonella and E. coli, and they are expanding to other enteric pathogens.
And then I just threw out Denmark as an example, the DANMAP Report, which we all sort of look at as one of the pinnacles of integrated reporting. We, obviously, worked with them and asked the questions about how they are doing and doing things and reporting on things.
(Slide)
So, some of the issues on the table for this international collaborative group would be to talk about emerging bacteria. I just showed a whole bunch of those. We all know those are emerging and resistance is emerging. And it would be nice to know about what other people are seeing.
Testing methods. I mean we, obviously, debate a lot about our own testing methods, but they need support and they have interesting testing methods that they are using. And to ultimately compare our data with Fiji, we need to understand how they are testing their bacteria for resistance. So being able to talk about that, maybe harmonize some methods to a certain extent, or understand what the world is doing will help us compare data.
And then issues of reporting which we have -- again, these are all issues that NARMS is tackling right now, but resistant versus non-susceptible. What is the rest of the world doing, or what are other groups that are involved in this doing? How do you define multi-drug resistance? There has been a lot of debate on that in enteric bacteria. We have some good definitions for it in some of the other bacteria, but in enteric bacteria, how do we define it, by drug, by class?
And then statistical issues, you know, do we put confidence intervals around things, do we not? How are other groups doing that? These are some really, really interesting issues that would be, I think, perfectly vetted in an international collaborative group that is specifically working in these areas. So these are some of the things that we would like to put on the table and to talk about at this group.
(Slide)
So, in putting together this collaborative effort, we have taken some first-steps. We introduced the concept at an Enternet meeting last year in June. We continued discussions this year in June about the format of this group at the Enternet meeting that happened this year. We plan on presenting and talking about forming it, and coming up with some plan at the Antimicrobial Resistance/Global Salm-Surv meeting that is going to be happening in Canada in September that Rebecca Erwin and Lei King are hosting.
And then, I said network, I should have said working group here, but the concept of actually launching this thing would happen in collaboration, or in conjunction, with the ICEID meeting at CDC in Atlanta in March of 2006. So that is sort of right now the proposed plan for how we are planning on moving forward.
(Slide)
Again, the format would be very similar to the International Collaboration of Burden of Illness -- at least we envision it -- in that it is a loosely affiliated group that meets quarterly on the phone, as many people that want to, that has an agenda that discusses some issues for an hour, an hour and a half, and that informs collaborative efforts outside of that, which we have all been doing. And then, potentially, could try to meet face-to-face once every other year, or something like that.
Again, the group would need to define how formal it wants to get. But there is just so many issues that we want to discuss and talk about, and there has been a strong sort of grassroots movement to get this group together that we are excited to try to make it happen.
And then now, I guess I will turn it over to Shaohua to talk a little bit about PulseNet.
Comments
by Shaohua Zhao, D.V.M., Ph.D.
DR. ZHAO: Good morning. Yesterday, I talked about PulseNet U.S.A., and today I just wanted to briefly talk about PulseNet International Program. PulseNet was established in 1996, --- that time just --- U.S. Now, we have PulseNet Canada, PulseNet Euro, PulseNet Asia Pacific, and a PulseNet Latin America.
(Slide)
PulseNet U.S.A., as I mentioned yesterday, we have over 70 laboratory participants that include --- PulseNet Central, 50 state public health laboratory, and the 12 county and city laboratory, two USDA laboratories, and the eight FDA laboratories.
PulseNet Canada, they have nine federal and province laboratories. They are one of the earliest countries to join PulseNet, so right now, they have -- just like one of our states, we have daily communications through their web ---, so they are very active participants with PulseNet.
PulseNet Europe, they have 54 institutions from 28 countries. The headquarters is in Denmark, so I think right now, now that they are ---, through the online, PulseNet cannot communicate with --- I don’t know when we will be online communicating with PulseNet and CDC, but they still have lots of --- in structure, you know, internally --- later work.
PulseNet Asia, they have 12 countries and 13 laboratories. So the headquarters is in Hong Kong. So the --- PulseNet has invited scientists from different regions to come to cities, all cities. All cities --- they also send the people in Hong Kong and the training in the Hong Kong.
PulseNet Latin America, they have 13 countries. I think PulseNet has cities they send the scientists, they train in Argentina. Argentina is their headquarter.
I think I want to give an example here about the PulseNet in Canada. How closely they are working together to show some of the significance to protect the public health. 1999 PulseNet Canada, they have some non- --- due to the dog treats. So they have the same pattern as the U.S., but we do not have the pattern made. The same pattern, but because there is --- dog treats, CVM has regulated those --- or dog treats.
So the same --- is a program. So we do have isolates and multi-drug resistant, some --- from the domestic or the imported food from Canada. Found out the same, there is non- --- contaminated with dog treats. So FDA said to publish a warning to the nationwide to be aware of the problem.
So that is the example how successful --- with another country’s problem, but we take the action to protect the public and the U.S.
(Slide)
So why should PulseNet go to the international? I think pattern, the team pretty much covers what I said here. You know, because we live in the global community, and the food produced --- part of the --- consumed in another part of the world. Diseases transmitted through the food should be addressed as a global problem and that is why we need effective global early warning system. And the global --- worker and the communication will allow us to utilize the scarce public health resources effectively.
And, lastly, I want to give another example here. Two years ago, Denmark outbreak cipro resistant to Salmonella ---. So because of the global Salmonella program, or PulseNet program, so we have the ---. So this --- to say is anything the U.S. to say that is a PFGE pattern? So we compare, we take the -- this is just an e-mail. So we compare that data fingerprinting to all databases. We look at the domestic. You know, we do have any single isolates to share this exactly same pattern. Because the cipro resistant -- you know, Salmonella is, I think, very low in this country.
So, however, we look at it as an importer for the isolates. We have collaboration with FDA field laboratory. They service imported food to look at the Salmonella isolates. So we do the DNA fingerprinting, and there we compare this importer for the isolates. --- have exactly the same PFGE pattern.
An interestingly, --- is also the cipro resistance. So we e-mail back and say -- they say that they found a dose of cipro --- is isolated from imported Thai chicken from Thailand. So we look at the back-up to our data, those isolates are also from Thailand too, but it is from a safe food. You know, it is interesting, we don’t know exactly how the chicken farmer, or fisherman, how close they are to each other. Or I know some Asian countries use chicken feces to feed the fish in ponds.
But, anyway, maybe that is kind of to let us know how the Asian countries -- how the --- use as an animal environment. It is very effective to know this can be just a global problem.
So I think a leverage is the network to respond to other emerging infectious diseases or acts of bio-terrorism. Thank you.
DR. YOUNGMAN: Are there any questions about the international issues related to NARMS?
DR. KOTARSKI: Yes, I had one question. When we looked at the NARMS budget yesterday, what percent of the NARMS budget is attributable to these activities?
DR. WALKER: $101,000.00 goes to the WHO Salm-Surv.
DR. YOUNGMAN: So that is in addition to that money that is divided for that, we also supply trainers to go for two weeks at a time to provide training sessions.
DR. KOTARSKI: Was that in the budget that we saw in yesterday’s budget?
DR. YOUNGMAN: It was, yes.
DR. KOTARSKI: Oh, okay.
DR. YOUNGMAN: There was a line-item for $101,000.00.
DR. WALKER: Right.
DR. KOTARSKI: Okay, thank you.
DR. YOUNGMAN: In 2005. Each year, it is a different amount depending upon our appropriated dollars.
DR. MILLER: But $100,000.00 is not the same as the personnel.
DR. YOUNGMAN: No. The personnel is in addition to the $101,000.00.
DR. MILLER: And that is not in the budget.
DR. YOUNGMAN: That is not in the budget, no.
DR. KOTARSKI: I had another question. I think it is very impressive that you can link up all these isolates across the world. It is very impressive.
Did I understand correctly that we get chicken imported from Thailand as part of our meat supply? Did I misunderstand?
DR. ZHAO: No, that is in Denmark. Denmark gets chicken imported from Thailand. But we, our field laboratory inspectors are mostly safe food import. Imported from Asian countries. So the ---. You know, imported chicken in Denmark, and we --- from Thailand ---.
DR. KOTARSKI: And just a general question. From what you have learned so far, do you see regional-specific serotypes and pattern?
DR. YOUNGMAN: I am not certain ---.
DR. KOTARSKI: Yes. But do you expect to see very different PFGE patterns across different parts of the world? So when you do see a match you say, ah, we didn’t expect to see anything.
DR. ZHAO: So far, we only did it at two years of research. This was imported through the isolate. In general, they are a very different pattern. But a --- is exceptional. You know, because --- which country --- a pattern. But in another --- type, there are general bridging from what we see in this country.
DR. CHILLER: And I will answer that too. In Global Salm-Surv we work really hard initially to try to get people to serotype Salmonella. And so we have a pretty good idea now internationally about where serotypes are occurring. And there clearly are differences, and it is exciting to see those differences.
At the same time, we have also been able to use these serotype differences to identify outbreaks, as sort of Shaohua is saying. If we are seeing -- just to give you an example, we had a Salmonella wealth of raden -- which is a rather rare serotype in this country -- outbreak in a prison in this country.
We know Salmonella waltaraden is the most common serotype in Asia. So immediately, because of that knowledge, we were able to think. Well, maybe there is something being imported from Asia. Maybe it is homegrown, but certainly we were thinking what things. And we know waltraraden is very much associated with seafood in Asia. So, immediately, it went toward that sort of hypothesis, helping us generate the investigation. And, I think, at the end of the day, we implicated tuna from the Phillippines.
But yes, there are ways that we can already show that this kind of data and information is helping us here locally. And, yes, when you do see matches, even in a serotype, it can be very, very helpful in performing an investigation and understanding epidemiology. So you don’t even need to even go to pulse field. Although, pulse field has helped us identify chocolate outbreaks, for example. German chocolate being imported in the United States, pulse field gels were matching on that.
So it can be very, very helpful, but sometimes you don’t even need to take it to that level.
DR. YOUNGMAN: Thank you. Yes?
DR. AIDARA-KANE: It is not a question, it is a comment from WHO. I would just like to express our gratitude to NARMS and all of our partners who are working hard to sustain Global Salm-Surv, because it is really a great program. It is amazing to see how we are successful in building capacity inter-laps in developing countries. And what is most important is to see people from the same country coming to Global Salm-Surv.
Epidemiologist and microbiologists, who they don’t know each other, who were not able to share information. And only the fact that they meet and share information through Global Salm-Surv training process make them start something on several of foodborne diseases into their countries. It is really a great program and I would like to thank all of the partners. NARMS -- CDC is working very hard on this program, and is really the force that is behind WHO. The main --- falls behind WHO and I would like to thank all the partners of Global Salm-Surv on behalf of WHO.
DR. YOUNGMAN: Thank you very much. Are there other comments about international?
DR. ALTEKRUSE: I have a question. Some of the partners, especially, developing nations, what are sources of funding that they are identifying to get their projects off the ground?
DR. CHILLER: There is a lot. A lot of different sources of funding. Some of them are reaching to the World Bank, for example. I mean, I will start at the big level. Some people are reaching out for funds to the World Bank. Brazil has a very big amount of money from the World Bank that has been given to their ministry of health. And the ministry then decides how they want to spend it. And they have decided that foodborne disease surveillance, Salmonella surveillance, is important.
It turns out that salmonellosis in Brazil is a huge, huge problem; yet, they don’t serotype. So they don’t really know where it is coming from. So they are very excited about getting serotyping going down in Brazil. They have decided to dedicate some of those World Bank funds; which, of course, is a loan that they get which they have to eventually pay back. They have to decide. They have decided to dedicate that to Global Salm-Surv training in capacity building in foodborne disease surveillance.
So that is just a big example. There are then funding organizations like JICA, from Japan. Japanese International Cooperation Agency that has funded, and co-funded some activities in Asia. Then there are local sources of funding that we help partners go after and try to help them identify. Or they may identify with us a local source of funding that we can help them tap into.
I think as Pat mentioned, these international activities, although both FDA and CDC have given about $100,000.00 each year to Global Salm-Surv that goes up to WHO -- that, obviously, not a lot of money, you can run two training courses.
So I think we all do a lot of -- I think we all volunteer a lot, I think we all try to be as creative as we can in funding. And we are constantly looking out at new opportunities and new possibilities; including, USDA that does a lot of -- they have, obviously, educational grants that they give. So we are constantly looking for new sources.
So I think we sort of have three ways we approach the global way. Like the Gates Foundation, World Bank. Sort of a national way, through donor countries, like the U.S. and Canada. And Australia has given some money. And then, actually, there are some funds within certain countries that you can tap into.
DR. YOUNGMAN: Any other comments on international issues for NARMS?
(No response)
DR. YOUNGMAN: Okay, the next thing on our agenda is to talk a little bit about funding. And Dr. Stephen Sundlof, who is our Director of the Center of Veterinary Medicine -- of which NARMS is, obviously, a part -- has said he would say a few words about NARMS funding. He is here with us today. I don’t think he has slides.
DR. SUNDLOF: No.
DR. YOUNGMAN: Okay. Thank you.
NARMS Funding
by Stephen Sundlof, D.V.M., Ph.D.
DR. SUNDLOF: Well, thank you. I am a poor substitute for Dr. Tollefson, I will just confess right up-front; who has really got a very firm grip on the budget of NARMS.
But I wanted to talk about a few things that I would really like to have this expert panel, as individuals, comment on and give us your thoughts. And then I want to talk about two different areas. First of all we, obviously, have to make the best use of the appropriated dollars that we have available to us. And in sitting here the last couple of days, I have heard a lot of really very interesting things that the money that funds NARMS now is being used to produce some really valuable information.
And it becomes an issue of prioritizing. Everything I have heard here sounds like it is just wonderful things that we need to do but, obviously, we can’t do everything. So help us, if you can, with trying to prioritize what you think are the most important things that we need to be doing.
And I think I heard Dr. Kotarski say yesterday, you know, really, we need to have a sense of what it is we want NARMS to be. And then once we have that vision, we can have a better sense of priorities about what we should be funding.
So, number one, what are the areas that are most important that we should make sure that those get the appropriate attention before others. And then the other thing is the future. What about NARMS in the future. And I think most of us recognize that the funding picture for, at least, the foreseeable future, through the appropriations process, is not a very pretty picture. That we will be seeing continued reductions in our appropriated budget over the next few years, as a result of the war and deficits, and other things.
These always turn around eventually, but right now, we are not in the best shape from the standpoint of looking at increases in appropriated dollars.
What I have heard during the last couple of days also is that, you know, one of the great successes of NARMS is it has been able to leverage off of pre-existing programs. And, you know, FoodNet, and PulseNet, and FSIS slaughter samples, all of those have really contributed to the success of it.
But are we at a point where we need to -- there are also some deficiencies as a result that those systems were not developed specifically for the purposes which NARMS had in mind. And we maybe ought to be thinking bigger and broader about what would it really take to have a system that would do all of the things that we really want it to do.
You know, the sampling systems that we have in place right now don’t really give very clear representation of what the true population of enteric organisms are out there; through no fault of anybody, except that they were designed for something else, not for what we want the information on.
So I wanted to kind of ask the experts here to think in broader terms about what it would really take to have a robust NARMS program. And then once we have that in mind, then I think it is up to us in the government to seek out funding. And we would do that with the help of a lot of folks.
One of the things that has impressed me about the NARMS program is that the number of stakeholders that are in support of this program. There is a broad base of support through a number of stakeholders. And when you have that kind of support, you can translate that into new dollars, new appropriated dollars, because that is how things get done in Washington.
With broad coalitions of people all pushing together with some coordination, I think we can -- it would be my desire to try and work up a budget that we can work over the next few years to try and gain enough support for that, that we can take it at some point to our appropriators and say, this is important, here is why it is important.
We will have a lot of folks supporting that, and really try and make NARMS a -- you know, it is already a world-class program, but really make it the world-class program. One that we can all stand shoulder-to-shoulder and present the united front and say, you know, we have the best program we can think of.
So that is really all I have to say. I would be glad to answer any questions, but just to preface my remarks that I don’t have detailed knowledge of the budget on NARMS. So, with that, I will see if there is any questions.
DR. YOUNGMAN: Are there any questions for Dr. Sundlof?
DR. ALTEKRUSE: Yes. Could you elaborate on some of the broad coalition outside of the government? Just to help us.
DR. SUNDLOF: Sure. Well, we have recently had live interaction with the Animal Agriculture Coalition. It is made up of a number of the trade organizations, including the ADMA. But Lyle may have a better list, but you certainly -- you know, pork producers, National Cattlemen’s Association, National Chicken Council, National Turkey Federation, Sheep Association -- who am I forgetting Lyle? The Farm Bureau.
MR. : Veterinarian medical colleges.
MR. : The Meat Institute.
DR. SUNDLOF: Yes, the Meat Institute. And all of them are very supportive of NARMS. So that is a big coalition. It is also very popular among the consumer advocacy organizations, so there is a strong stakeholder base there. It is in some ways, it is very unusual to have that broad of support for a program by groups that generally don’t agree with each other on anything. They, generally, agree with each other that NARMS is important.
DR. YOUNGMAN: Are there some other questions on funding?
DR. SUNDLOF: Oh, we have a list of the Animal Agriculture Coalition. The American Farm Bureau Federation, American Feed Industry Association, American Meat Institute, American Society for Animal Science, American Veterinary Medical Association, Animal Health Institute, Livestock Exporter’s Association, National Cattlemen’s Beef Association, National Chicken Council, National Grain and Feed Association, National Milk Producer’s Federation, and National Pork Producer’s Council.
That is just who sent me the last letter. I think there are additional members on that, but it gives you a sense of who is out there.
DR. VOGEL: Yes, I think there is about 30 to 35 different organizations that are participating with the Animal Agriculture Coalition. They come together in different formats on different issues, depending upon what their interests are. So, on this letter, there is just some of those organizations sign onto that letter.
DR. SUNDLOF: And what the Animal Agriculture Coalition does is -- one of their functions is to make sure that the appropriations committees -- generally, the Agriculture Appropriations Committee -- is aware of the issues that are important to them around the time that they are working on the budget. So they are a good source of -- they have a direct access to the appropriators. They interact with them on a frequent basis and they make sure that, again, when the appropriations bills come up, the issues that are important to them get the attention of the appropriators.
DR. YOUNGMAN: Are there other questions for Dr. Sundlof?
(No response)
DR. SUNDLOF: Okay, thank you.
DR. YOUNGMAN: Okay, thank you very much.
Well, I guess now is a good time for a break. I can see that they brought the refreshments for our break. If we could take 15 minutes, we are ahead of schedule; which is a good thing, a good position to be in. And if we can reconvene please at quarter to ten. Thank you.
(Whereupon, a brief recess was taken)
DR. YOUNGMAN: We are about ready to start again.
(Pause)
DR. YOUNGMAN: While you are getting into your chairs, I just wanted to remind you of a couple of things. One is this morning there was a booklet that describes the NARMS Program that was provided on the table outside. If you don’t have a copy, please help yourself.
Also, Elvira asked me to remind you that she put out on the table also home pages for the USDA’s report on NARMS for the FDA’s report. So it just briefly describes what is there if you want to check on your computer when you get back to your offices what kind of information we have on our web page. And this is the CDC’s report, so this shows you where to go and how to get more information that each of the arms have for NARMS.
Panelist Comments on Questions Posed by NARMS
by Linda Youngman, Ph.D., Moderator
DR. YOUNGMAN: Now we get to the part where we start to talk about the panelists’ recommendations. And before I start that, I just want to say I have sensed over this past day and a half how much enthusiasm there is for NARMS from a lot of different people. And that is a good thing. I would like to build on that enthusiasm and just say that it is clear to me there are a lot of people who really are working very hard on NARMS and want it to become the best program it can possibly be. So we are really looking to your advice in helping us achieve that.
So if I can just run through the questions that we would like each of the panelists to consider individually. The first question that we posed to you was, is the current sampling process by FSIC adequate and effective for Salmonella surveillance? So this has to do with the animal isolates. Are these samples adequate and effective for campylobacter? There are possible concerns about campy dying. So are there better ways to get samples that are adequate and effective?
What other pathogens should or should not be isolated and susceptibility tested from the poultry rinsates? If additional sampling is suggested, please consider what we should stop doing since no additional funding is available for NARMS. So if we want to add new things, or embellish and existing program, it means that there are other things that we are already doing that we need to stop.
Are the current sampling strategies for the retail meat arm of NARMS adequate as currently conducted? Could we be doing a better job? Should we change our strategy on that?
Issue three, is reporting sufficient to be able to use data from the three arms effectively for public health surveillance? And how would you change the reports? So there are examples of reports out on the table here. So how would you change the reports to accomplish us being able to use data from the animals, from humans, from retail meat?
What should be retained, or what should be omitted, from future reports? How can we work toward those three reports being -- you know, for us to be able to use the data interchangeably between the three arms? What are the top three elements of a well coordinated collaboration for the molecular characterization of isolates from all three arms? We are doing that in all three arms so that we can demonstrate or refute a continuum from animal, food, and human origins for specific pathogens and/or resistant phenotypes.
The fifth question, how should NARMS be involved in international efforts? We heard a bit about that today and that is an area that is really critical to NARMS, in our opinion. And sixth, how do you suggest that we enhance and sustain funding for NARMS?
So, what I would like is to ask each panelist, in turn, if they could take say 15 minutes or so to respond to these six questions. I also want to start by thanking all of the presenters and attendees today, and the panelists. We really look forward to a vigorous discussion of the six questions that we posed, and also your comments on ways that we might be able to strengthen NARMS. We really want to do that, so we look forward to your comments today.
So if I could start with Sean Altekruse, if you could give us some of your comments on those six questions. Oh, sorry, did you have a comment before we started?
DR. KOTARSKI: Yes, I have a question about protocol. Would it be useful to go through one question at a time by the individual panelists, as opposed to going through all six over and over again?
DR. YOUNGMAN: We can do it that way if that is your preference. Okay, shall we start with the first question then?
DR. ALTEKRUSE: Could I make a suggestion related to protocol as well? And that is that since I am an FSIS employee, I think it might be interesting to hear from other members of the panel on this first issue before I said anything.
DR. YOUNGMAN: Okay.
DR. VOGEL: I can start. Do you want to go this way?
DR. YOUNGMAN: All right, that is fine. Do you want to start Lyle?
DR. VOGEL: Before I start addressing the specific issue, I just want to get on the record that I hope whoever is looking at the transcript to develop the report for the Science Board will look at all the comments and questions that were asked by the panel members through yesterday and this morning. Because there were, I think, a lot of good points made on these issues, as well as others, by the panel members.
And I would hope that you don’t just concentrate on this session on developing the report for the Science Board, but look at the whole transcript for the whole two days.
DR. YOUNGMAN: Yes, that is a fair comment. We definitely will look at all the comments that have been made throughout the one and a half days.
DR. VOGEL: Thank you. And in that report -- I guess it is a protocol issue too -- is it possible that this panel can take a look at the draft of the report to the Science Board before it is submitted to make sure -- you know, sometimes I have trouble enunciating or making sure that I am saying things the way I really intend them to be meaningful. And I guess I would like to have an opportunity to make sure that my ideas and thoughts are captured correctly.
DR. YOUNGMAN: The plan is for the transcription of the day and a half’s proceedings to be put on our web page. And, certainly, you could have a look at that before it gets put on the web page to make sure we have accurately reflected what you said today.
DR. VOGEL: I am asking for a little more than that. For a look at the draft report for the Science Board.
DR. YOUNGMAN: I am not sure what the rules and regulations regarding that are. Certainly, if we can do, we will do.
DR. VOGEL: I appreciate the consideration of that.
DR. YOUNGMAN: Okay.
DR. VOGEL: For the first issue, is the current sampling process by FSIS adequate and effective for Salmonella surveillance? Well, first I need to start -- I don’t know that I can answer that question without knowing what the objective of the sampling of the FSIS sampling is.
So I will start there. So, without knowing what the specific objective is, I cannot judge whether it is adequate and effective. Now, if the objective is to determine changes over time in the percent resistant of Salmonella isolated for slaughter and processing, well, then I think the sampling process is currently adequate to do that.
As explained, it is not a national representative sample, so we cannot make predictions of what the percent resistance is in slaughter samples. But, we can examine what the changes are over time. You know, we can look at trend data.
I do have a caveat. I am not sure whether the numbers are currently adequate to do everything that we want to do with those Salmonella slaughter isolates. If we want to quickly identify emergence of infection of resistance, well, then I am not sure if the numbers are adequate to be able to identify that quickly. Especially, if we are looking at rare serotypes and strains of those serotypes.
If the objective of this surveillance is to help FDA regulate on-farm drug usage through the approval, disapproval, or withdrawal of drugs, then this system is not adequate. And it is not effective. What we need is an on-farm surveillance system that can record resistance on-farm in Salmonella and tie that with the epidemiological data, such as drug usage on those farms. So in that aspect, I guess I would be supportive of a program such as the CAHFSE, the Collaboration for Animal Health, Food Safety, and Epidemiology. An expansion of that program, if the objective of NARMS is to help FDA regulate drug usage.
That is it. Thank you.
DR. YOUNGMAN: Well, if I can press on that point. You have spoken in favor of on-farm sampling and also trying to monitor drug usage.
DR. VOGEL: Right.
DR. YOUNGMAN: Do you have a proposal for how to go about that?
DR. VOGEL: I mentioned CAHFSE, Collaboration for Animal Health, Food Safety, and Epidemiology. And as I understand, that program will do that. It will take samples on-farm, it will follow those samples to the slaughter plant to determine if there is a change in serotypes, as well as resistance, between the farm and the slaughter plant and the processing plants. And the intent is also to record what drugs are used on those farms.
DR. YOUNGMAN: Just if I can press on that further, one of the things we have really been trying to achieve in NARMS is to be able to look at temporal trends. And, possibly, even further to detect problems where they are, year-by-year. One of the concerns if we use the CAHFSE structure is that -- as my understanding about that is -- is that one particular species wouldn’t be gone back to until five years’ time.
DR. VOGEL: No.
DR. YOUNGMAN: So you wouldn’t really be able to look easily at temporal trends.
DR. VOGEL: No, I think you are thinking of NAHMS, the National Animal Health Monitoring System, which does surveys on a five-year basis. CAHFSEs would be a yearly project.
DR. YOUNGMAN: Okay. Did you want to speak to the sampling for campylobacter? That was a part of the first question.
DR. VOGEL: Okay, are these samples adequate and effective for campylobacter? Well, I think some of the same comments I made for Salmonella apply here. You know, what is the objective for sampling for campylobacter. If it is to examine trends, changes over time, it is probably adequate. If we are looking at trends of resistant campylobacter from poultry rinsates since 2001. If the objective is to look at all campylobacter, well then no, it is not adequate. We need to get sampling from other products, such as pork. Do you want me to go on with the others then?
DR. YOUNGMAN: Sure.
DR. VOGEL: What other pathogens should or should not be isolated in susceptibility tested from the poultry rinsates? I don’t see any additional that need to be added. If we come down to prioritization and need to start cutting testing, I would suggest looking at testing of cutting Enterococci testing. I am not convinced that that has given us a lot of useful information about human illness related to resistant Enterococci. And, I guess, I would also maybe just do minimal E. coli testing from those rinsates.
DR. YOUNGMAN: Okay. Are there things you think we should stop doing in addition to those?
DR. VOGEL: No.
DR. YOUNGMAN: Okay. Thank you very much. Can I go to Awa next.
DR. AIDARA-KANE: Yes, thank you. For the first part of the question, I think that, although not adequate to estimate national surveillance, the sampling can provide descriptive data on trends over time of antimicrobial susceptibility for Salmonella. And I think that it would be useful to monitor antimicrobial use at farm level. Can you hear me at the back?
DR. YOUNGMAN: If you move the microphone maybe a little.
MS. : If you speak into the mics and a little louder, that would be great for us in the back. Thank you.
DR. AIDARA-KANE: Okay. So I think that the sampling process is not adequate for effective Salmonella samples, but it can give an idea of trends over time on antimicrobial susceptibility testing. It would be also useful to monitor use of antimicrobials at farm level and try to link antimicrobial resistance to antimicrobial use.
I think that there is selection bias, because the plants that do not meet the regulatory performance standards can be over represented. So I think that this can lead to a bias. And the fact that there are more frequent sampling during the first six months of the year can also lead to a bias on representativeness all over.
Concerning campylobacter, I think that campylobacter are fragile organisms and the fact that the isolation is delayed and the samples are delayed, may lower the number of positive samples. But still, it can give an idea of antimicrobial resistant campylobacter.
Concerning other bacteria of interest, I think that if we have to add one bacteria, it should be E. coli as indicator micro-organism. And I don’t think that testing Enterococcis is of interest.
If less funding is available, I think that one way to lower the cost should be to avoid taking multiple samples from the same source. That is all.
DR. YOUNGMAN: Thank you very much. We appreciate your comments. Thank you. Scott.
DR. MCEWEN: Well, thanks very much and I appreciate being asked to come and comment. I always find this very informative and enjoyable. When I was preparing my comments, there was a number of issues that cut across and all the questions are maybe sort of broader than the questions. So I have got some notes on that and ask you if you want those --
DR. YOUNGMAN: Maybe after we address each specific question, we can open it for more general comments. Would that be okay?
DR. MCEWEN: Yes, as long as we have time for that.
DR. YOUNGMAN: Okay.
DR. MCEWEN: With respect to the first question, I agree with what previous panel members have said. So it all depends on what the objective is, I guess. I also didn’t see, and would encourage you to undertake a formal revisit of the design issues and undertake a specific design; including sample size estimates in order to see whether the available samples -- how they fit with -- how you would design a program to fulfill the objectives.
Based on what we heard in the short time there has been to sort of look at it, it seems to me that the baseline samples are probably most ideally suited to identifying prevalence in slaughter animals. I think with respect to information from the other isolates, I would like to see some epidemiologists and statisticians turned loose to identify how some verification samples can be used in a meaningful way. I have got some of the same concerns that were raised yesterday and today about their representativeness. And inferences that can be drawn from those.
We will be talking later about budget, but I guess in the face of at least short-term budget issues, you kind of have to work with other partners and leverage other efforts. But I think you can try to do that in a sort of more meaningful way; perhaps, by sampling some of the available isolates in a more strategic fashion.
With respect to other pathogens, I think it is important to prioritize. Dr. Sundlof said, and for that, the major foodborne pathogens are top priority, and Salmonella and campylobacter, obviously. But I, certainly, wouldn’t want to see the commensals cut from the program. I think we could maybe be strategic and --
DR. YOUNGMAN: The Enterococcus and E. coli.
DR. MCEWEN: As representatives of gram negative, gram positive populations that -- Enterococcis has been sort of walking the line between a pathogen and an indicator species, and so we have heard a bit about its role in both camps. But, I think, it is important to have a representative species for sort of both major groups. And I am not sure that we need to have thousands of isolates, but at least a bit more strategic there.
And whether they come from poultry rinsates or whatever source, whatever works out the best, but I agree that we need other species represented there as well.
In terms of the concerns about campylobacter isolation from the rinsates, I guess there is an issue of survival, and then that affects prevalence, so we have to be careful about making -- but unless it results in a differential loss based on resistance, I think we can still make inferences about prevalence of resistance among cultured organisms. Maybe not prevalence of resistance at the carcass level if there is going to be loss of campylobacter.
What should we stop doing? I guess I have kind of addressed that in terms of being more strategic in sampling. With respect to identifying other areas that need to be sampled, such as farm, and so on, I think I will leave that for the funding issue, because I think it is tied in with that.
DR. YOUNGMAN: Okay. Thank you very much. Thank you. Marissa.
DR. MILLER: Thank you for the invitation to be here. It has been very gratifying to see how this program has grown and matured in all the different areas now. You know, you are conquering the world, and I like that concept.
I just have a few thoughts. I am kind of echoing what Dr. Vogel and McEwen have already touched on, that I think you do need to go back and re-evaluate the original mission goals and objectives, along with your stakeholders. Because there may have been a bit of a mission creep in what has gone on over the years.
And, I guess, to start with the animal, the FSIS sampling for Salmonella and other pathogens, I really think at this stage of the game, what is needed is more than descriptive data; which was in the original kind of mission statement. I think that I would strongly encourage the agencies collaborating here to move towards a nationally representative sample of slaughter isolates, if at all possible.
Not to say what has been done in the past hasn’t been useful, it has. But I think you are bumping up to a point where if you want to use these data in making policy, being able to go forward into litigation and other areas, and be able to say what the data represent, they need to be based on a nationally representative sample.
And Sean suggested in something he said, and I don’t know if this is just a thought or in the plans or not, that FSIS may move back to the baseline sampling strategy. Kind of pre-HACCP, which was a nationally representative sampling scheme.
If that is possible, that would be wonderful. I think that there are other options if you had some good statisticians working with you to look at the type “A” facility sampling and how to do that. You could probably get there as well from that direction. And as I said, I think this is a critical element at this time.
Now, that having been said, I also have some concerns about possible overlap between what the data will be telling you from the slaughter samples and the retail meat arm. So I think that what you should do in the near future is do a side-by-side comparison of those data and that information and see, actually, the nuances and what is most useful for the missions of the different agencies.
In case the slaughter isolates are actually telling you what you are already seeing in the retail. That may or may not be true, I don’t know, and there needs to be some studies looking at that.
I think that what Dr. Vogel was saying about the following from the farm, including the drug use into the slaughter facilities is extremely elegant.
And I don’t know if that would be tied into the surveillance system, or that would be an off-shoot study that could be done, or done on an ongoing basis. But that is very compelling and would answer some of the really basic questions we have been asking for so long about causality.
Let’s see, I have rambled now for awhile. As far as campylobacter, I think more thought is needed here, from what I have heard. Because of the issues related to losing the very sensitive organisms. And I pose a question, I don’t know the answer, but could sampling earlier in the slaughter process be more productive as far as getting a more reasonable estimate of the prevalence of campylobacter?
And also, on the other side, are the retail meat samples actually giving you more information, or more useful information? So, just some questions to consider as you move forward in that area.
There weren’t any other pathogens that I could think of that need to be looked at at this time. I think you have a very comprehensive spectrum. I guess I would agree with the other presenter, or the comments made, that if you want to focus down, the commensals are less relevant if you have to make cuts, then the pathogens. And I guess I will stop there.
DR. YOUNGMAN: Okay, thank you very much. Sue.
DR. KOTARSKI: Yes, I want to first say thank you for inviting me here and I just want to say I am just so impressed with all the information you have collected over these many years and the expertise that you have accumulated. It is an honor for me to be here and I feel like you should be telling me about the answers to these questions, quite frankly. I think you can do a great job on that.
But, since I am asked, I would like to echo, actually, many of the sentiments that have already been expressed by the panel members. The first question I would have is, in response to the question, is the current sampling process by FSIS adequate and effective for Salmonella surveillance? Again, surveillance of what and what is the objective of the surveillance program.
There can be many surveillance objectives. One, to understand the temporal trends on a national basis. A second can be a surveillance system constructed with emphasis to provide an early warning program of resistance emergence. It can be set up as a portion of a program in risk assessment and in support of our Guidance 152 platform within that framework, within that framework, for our drug approval process.
And I am sure that members of the group, as well as this panel, can provide other objectives as well.
So given that, it is difficult to answer the question. The system is it is designed to obtain Salmonella from the HACCP Program includes the A and B and C sets. I do question, based on the presentations yesterday as to whether or not the B set and the C set are needed in terms of providing national representation because of the bias.
Or, if you are going to consider continuing to provide resistance information about B and C set, please provide the public information about that bias, and to the extent to which it is a component of that data-set that you are providing. It helps everyone as you provide this public data to understand that bias and to go forward.
With regard to the campylobacter, is that adequate and effective? Yesterday’s comments about the implications of isolating campylobacter from the rinsate materials brought questions to my mind as to what biases that actually introduced if that is significant for the purposes of resistance monitoring. How does that bias the campylobacter set that we do obtain as to the percentage resistance?
I would ask the group to consider that bias, and if they do identify a bias, then to provide that in the information that they provide in their published documents, in the commentary.
What other pathogens should or should not be isolated in susceptibility tested from the poultry rinsates? I would like to comment on the E. coli and the Enterococcus, only from the interest of focus. My understanding is is that by the time we get through the six questions, we will say what should we emphasize and what shouldn’t we emphasize.
My understanding is is that the E. coli and Enterococcus isolates are a component of the program, or future program, as a sentinel indicator of resistance emergence. If that is the case, I would like to know the database we have, or the database we intend to generate to allow us to say, yes, by monitoring E. coli in these isolates, we are predicting the likelihood of certain types of resistance plasmas, or whatever.
In other words, there is a lot of resources expended in getting those isolates, and if you are going to go for that for the purposes of sentinel, try to generate that database to help you decide that, in fact, you will be meeting objectives of having sentinel organisms on resistance emergence.
Or, possibly, just focus on your campylobacter and Salmonella. Take resources, expend them on understanding -- getting more campylobacter and more Salmonella isolates so you can fulfill your primary goals if, indeed, that is what they are.
If additional sampling is suggested, please consider what we should stop doing on NARMS, since no additional funding is available. I wouldn’t suggest to do additional sampling, per se, but I wanted to emphasize that as we look at the slaughter isolates, if we are going to use that as an indicator of healthy foods, from my standpoint, it seems that the slaughter isolates represent contamination of Salmonella and/or campylobacter due to the animal as it came into the plant.
It also represents that contamination that occurred as a result of commingling of the animals before they entered the plant, the contamination that occurred at the truck, the contamination that occurs at the slaughter plant.
So, as a representation of resistances occurring on-farm, it provides the information collectively about the contamination. So I don’t know, it is an indirect indicator of resistance that occurs on-farm. And if we look within the nom-sampling for a particular year, for a particular commodity, versus what we see for resistance in the slaughter plants for that same commodity, I am not sure that we would see the same numbers.
And I would ask the group to think in terms of making those comparisons between a broad national base where you have resistance information on-farm, versus what you see in the HACCP Program; particularly, just the A sets and say, are they the same, are they representative, do I have the information to go forward and say this is what I have for resistance on-farm. Does it adequately represent, or is it predictive, of what is on-farm. If the answer is no, or you need information to address that, then try to find out if you can do that. I guess I have said enough.
DR. YOUNGMAN: Okay. Thank you very much. All right, Sean.
DR. ALTEKRUSE: I just wanted to thank you for the conference, it really shows how far things have come in the last 10 years. I think that everything that has been done, and that was talked about, has been worthwhile. It is just we are in a slightly different environment now.
I am confident that after we go through this particular cycle, the program will be stronger. And, in fact, it is kind of useful to assess where we are with what we know now. And, you know, adapt accordingly.
In terms of is the current sampling process for the FSIS isolates adequate and effective, that sounds like a yes/no type of questions. But really, there are a variety of issues there. First of all, those are regulatory isolates and, therefore, they are of a lot value to FSIS.
Secondly, we are at a crossroads in terms of how we are doing our HACCP verification testing. And, in the past, it wasn’t an absolutely perfect representative sample, but it was pretty good. And I think it worked. But, as we move towards risk-based verification, we are going to be sampling more frequently in establishments where we think there is evidence of Salmonella problem. And it will become less representative.
So, it may be worthwhile considering adding a carefully designed, nationally representative sample of slaughter isolates to this activity. So if I can jump ahead to if additional sampling is recommended, what should be done since no additional funding is available, perhaps, this could be done as part of CAHFSE. So, additional funding could be identified for this purpose.
And, secondly, if we really are forced to cut, I might suggest that the emphasis be placed on serotypes that appear to cause human illness. Because I think the objective of NARMS is related to human illness, and we are not so interested in serotypes that occur with a high frequency in veterinary isolates, but aren’t particularly common in people. Just a thought there.
In terms of are the samples adequate for campylobacter, Dr. Walker mentioned yesterday -- or, he had some question about the 24-hour shipment at four degrees Celsius, and whether we were getting survival -- or, perhaps, some viable, but non-culturable campylobacter as a consequence of that. And I think that could be addressed very easily by taking rinses and doing same-day plating and 24-hour plating to see if there is a substantial difference in counts, or in prevalence.
In fact, my guess is the answer is likely to be no. I think that the coccoid state for campylobacter starts to come into effect at about 48 hours. But there is an inherent issue with campylobacter that will be difficult to address, and that is injured cells and detecting of them.
What pathogens should also be considered? Dr. White presented some data about campylobacter coli yesterday, showing macrolide resistance. And campylobacter coli isn’t found with high frequency in poultry isolates, to the best of my awareness. So my question is, what would be the reservoir of that in people? That type of infection? Two possibilities are turkey and pork.
Now, the ground turkey isolate, the ground turkey samples at retail are not, particularly, ideal for campylobacter because they have been through the grinder, literally. And you don’t find very high rates of campylobacter in those samples. So, I don’t know, perhaps, some of our turkey sponge samples could be added to this activity and, perhaps, some swine samples as well, just to see if we are finding C. coli. and if they are macrolide resistant. It is just a thought.
In terms of the baseline concept, I think in this sampling for other pathogens, maybe that would be a good time to do a little pilot study beforehand to see if there are differences in prevalence and enumeration, depending on the media and the atmospheres that are used. And that might be done before FSIS starts its 2006 Campy baseline. Sometime in the next budget year. I think that is all I have got. Thanks.
DR. YOUNGMAN: Okay. Thank you very much for your comments.
DR. YOUNGMAN: If we could start with question two now. In the same order, Lyle, do you want to comment on question two.
DR. VOGEL: Okay. Are the current sampling strategies for the retail mea arm of NARMS adequate, as currently conducted? And I guess I have questions about the sample sizes that we are testing. Even though they are increased, maybe even doubled since 2002, I think when we start looking at the rarer serotypes -- well, maybe not so much the rarer serotypes -- but at least in 2002, we are not getting very many isolates of Salmonella Newport; I think it was eight. And even Salmonella Typhimurium, I think we only had 15 isolates.
So we really can’t depend upon that data for giving us good trend data, much less resistance data for that single year. So I think we need a statistician, epidemiologist to really look at that sampling scheme and give good advice on what we need for sampling. But, again, that is related back to what is the objective of the retail sampling. So we need to examine that as well.
I also mentioned, and I have concerns about the E. coli sampling scheme. That is taking samples from only 4 of the 11 FoodNet sites. That if there is regional variation going on that is being missed by that sampling strategy, I would suggest looking at a systematic sampling from all sites. Maybe taking one out of every 20 samples from all sites. Or 1 out of 10, whatever is best epidemiologically.
I also would, like the previous question, I would advise take a look at Enterococci, and if something needs to be cut, that may be the organism that needs to be cut.
DR. YOUNGMAN: Okay, thank you very much. Awa.
DR. AIDARA-KANE: So I think that there is also a need to better define the objectives, and then to sample size estimate. According to the objective, may be helped by epidemiologist. And I think that we need to extend E. coli and Enterococcis testing to all the sites.
DR. YOUNGMAN: So expand from the four sites to all 10 FoodNet sites.
DR. AIDARA-KANE: Yes.
DR. YOUNGMAN: Okay, thank you very much. Scott.
DR. MCEWEN: Yes, just a couple of comments. I agree with what the previous people have said. I think the switch from a convenience to random sampling is a distinct improvement over the past. It enhances confidence and enables better interpretation of the results. I think the integration with FoodNet was an excellent move and strengthen, if possible. That makes a lot of sense in terms of integration with the other branches of NARMS and other activities.
The only other thing I would suggest is consider some pilot studies in other types of meat, like veal and lamb, and things like that. I understand the logic in targeting the high volume products, but in order to be more comprehensive, I think we have to look at some of the minor species and, hopefully, eventually include ready-to-eat products and so on. I think the whole spirit of the retail side is to try to get a closer picture of what consumers are exposed to.
DR. YOUNGMAN: So you are proposing looking at like luncheon meats, and things like that, for Listeria?
DR. MCEWEN: Well, nothing that specific. The only specific ones I would mention is to look at some of the named pathogens in the more sort of minor species of animals. So veal and lamb is two examples of that and, perhaps, others. But in terms of the ready-to-eat products, I think that needs a bit more thought and look for opportunities. But it should be on the list of things considered.
DR. YOUNGMAN: Okay, thank you very much. Marissa.
DR. MILLER: I agree with all the comments so far, so I won’t repeat them. The only thing I wanted to say in addition is I think there are a lot of opportunities that are starting to be taken for working together between the veterinary side and the human side in terms of the, I think it was monthly or quarterly, conference calls. And asking those next questions in terms of how you interpret the data in light of human disease in those areas. So I think there are great opportunities here.
DR. YOUNGMAN: Thank you very much. Sue.
DR. KOTARSKI: Yes, my compliments to the group in providing such a broad database and providing a solid database to go forward. I agree with the comments that have been put forward by the rest of the panel.
The addition that I might have to that is to, again, from the concept of focusing resources, is to consider -- you know, I just looked at the 2002 retain meat data. The number of isolates that were obtained for Campy from ground turkey was 4 out of the 300 and some isolates. The number of isolates of Campy for ground beef was 0 out of the 300 some isolates. And for pork, it was 5 out of the some 300 isolates.
So for the efforts that you expend in obtaining or conducting an isolation, you will get a lot of negatives. I wondered if you could work with a statistician, now having that previous database to say, okay, what sampling strategy do I need to have confidence that I will get “X” number of isolates. If I get those number of isolates, what confidence do I have in the percent resistance that I do measure from those “X” number of isolates? Because in this case, you are going to get from the database that you have generated for 2002, you would predict that you are going to actually get a very small number of isolates. So if one isolate has a resistance to whatever, you would have a 20 percent resistance rate. And so is that a matter of chance or is that truly representative of the area that you are sampling? And, of course, is it or is not representative of a national basis?
Again, we go back to the objectives. I think because of the broad database that you have already generated, by working with a statistician to say, here is the objectives that I wanted to accomplish in my sampling strategy, how many samples do I need, and with what confidence will I have in terms of interpreting the antibiotic resistance that I measure for those isolates.
It could be after thinking about it, you might decide I won’t expend the resources to get campylobacter isolated from ground beef because the likelihood that I will obtain a positive sample is going to be pretty low. So by extension, the confidence that I will have in identifying the resistance rate will be a wide-variability associated with that number. So you might want to rethink your strategy there.
Same comments apply to Salmonella. You had nine isolates in 2002 from ground beef, and you had 10 isolates from pork loins. So, again, it is the same thing. I would revisit that and revisit with the statistician about what is possible and the confidence you would have with the isolates.
The other thing that I might mention is, again, the concept of integration of the program and what is the primary and secondary objectives. If one of the primary objectives is to understand the implications of drug use in animals, and you are using this as an indicator, the retail meat is, of course, going to tell you what your product has as a result of the animal, plus the trucking, plus the commingling, plus the lehrage (phonetically spelled), plus the slaughter house, plus the processing that gets you to the retail meat product.
So it is even more indirect than the slaughter in terms of predicting or understanding what happens at the animal level. And also, when you think about the sampling strategy in using the FoodNet catchment areas which, I think, is an improvement, like has already been expressed by the panel members, to increase and enhance your understanding of exposure to the public at the retail level. It does increase the possibilities that you can do it for those catchment areas.
The implications for the national levels, I don’t have that expertise to comment. But at least that allows that intensive epidemiological sampling for the exposure retail to humans. The sampling strategy that you have for that, versus the information that you have from the food animal is such that we go back to the HACCP Program.
The HACCP Program is designed to get -- the national data level is not designed to reflect the catchment areas. So I don’t know how you interpret, or how you compare, HACCP samples to the HACCP sampling program, to what you have at the retail.
So, again, you come back to your objectives. What is your objectives for risk assessment? Is it for national prevalence levels, is it for epidemiology, and work from there in terms of refining your objectives. Or, excuse me, refining your sampling.
DR. YOUNGMAN: Thank you very much. Sean.
DR. ALTEKRUSE: I just wanted to note something. It looks like the actual prevalence, when the switch was made from a convenience sample to a randomized sample, it didn’t change very much. And I think that -- well, actually, what I am referring to is in the Iowa Study, it was a random sample and then, initially, in the FoodNet sites it was a convenience sample. And the percents were very similar.
So it is good to use a randomized sample approach, but the reason I bring this up is because I think the same sort of thing is likely to apply with the HACCP isolates. They are, in some senses, a convenience sample. But, I think, what we will find is that they correspond pretty closely with random sample baseline.
DR. YOUNGMAN: If I can just interject. That we haven’t shown data for the retail meats, subsequent to it being changed to a random sampling.
DR. ALTEKRUSE: Right. What I was saying is that in the Iowa Study, that was a random design.
DR. YOUNGMAN: Oh, okay.
DR. ALTEKRUSE: And then the convenience design had a very, very similar prevalence of resistance. And now we are going back to a convenience sample. And I suspect what we will find is that the two are very similar.
DR. YOUNGMAN: We are going to a random sample.
DR. ALTEKRUSE: I am sorry, it is Friday. It has been a tough week.
Now, let’s see. The only thing I would suggest in terms of the retail food samples is related to yield. And the skin on products, like chicken breasts, for example, may have a higher yield of pathogens. So if the objective is to look at the pathogens that are being transmitted via these various food producing animal commodities, it may be that, for example, sampling a turkey leg, or a turkey wing, could have some advantages for recovery of pathogens versus ground turkey. And that is, in particular, for campylobacter.
And then using primal cuts like pork chops, or is it pork loin?
DR. YOUNGMAN: Chops.
DR. ALTEKRUSE: But those are not cuts that are from near the surface of the animal. So they are, actually, sort of sterile site type cuts. And you may have a lower yield than if you took something like a picnic ham, or a picnic shoulder, or a ham sample with some skin on, for example, as your sampling unit.
The same thing with ground beef. There is meticulous attention being paid now to sanitary dressing because of O157. That seems to be the control. And ground beef trim is being sampled to make sure that it is free of even indicator organisms, to the extent possible.
So I don’t know if there might be some other product that would enhance the yield of the pathogens that are being transmitted. A skin-on type product, perhaps. Although, the skin is removed from beef, but something near the surface, like a flank. It is just a thought.
And, in fact, I think that the area where they are particular concerned is the back of the neck because that is where the incision is made for hide pulling. So I just throw that out there in terms of the retail product that is most likely to reveal the pathogens that are being transmitted.
But it is a trade-off, because you are getting away from the most frequently consumed product to the product that has the highest yield. It is just something to consider.
That is all I have.
Panelist Comments
Question Three
DR. YOUNGMAN: Thank you very much.
I guess if we can switch now to question three, which has to do with how data are reported. Is reporting sufficient to be able to use data from the three arms effectively? How would you change the report so we could use the data more interchangeably? What should be retained and/or omitted? And if we can start with you, Lyle.
DR. VOGEL: I think we should go a little more basic before we talk about the reporting, specifically. I have concerns that the whole program needs to be improved for public health surveillance. You know, as we talked about before, I am not sure that the slaughter samples are really reflective of what resistance on the farm, and I am not sure if the retail samples are reflective of on-farm, or the slaughter.
So, consequently, I am not sure that the sampling from humans is reflective at all of what is going on on the farm. So with that caveat, and we have discussed some of the ways to change that to make the NARMS more effective for public health surveillance, focus just on the reporting.
And I think we all agree that the current reporting via the three separate arms is not effective. We need to have a consolidated report where all arms are reporting the same thing at the same time in sufficient detail that the readers can understand the correlations, if there are any.
We need a summary report that reports all three arms; the human, the retail, and the animal. And on the animal side, we need the detail down to the separate species of animals and the separate sources of the samples for those animals. And on the retail side, we also need a detail as to the species of animals rather than, for example, consolidating all Salmonella together from all sources.
I am very thankful and grateful for the information that we have been given about the proposed changes, or the contemplated changes in the reports. And I think that is going to be a big improvement as that goes forward. I think one of the things that was mentioned that is under consideration, but I guess not a determination yet, is an interactive database. I want to emphasize to please give great consideration to that. A database that is available to stakeholders to gather the information that they need.
The other improvement, and we need to compliment all arms, CDC, USDA, and FDA in their efforts to make the reports more timely with just a six-month leg from yearly reporting. That that be a great step forward.
What should be retained and/or omitted in future reports? Well, I guess, in an ideal world, we would retain everything we have got now and then add other things. But I guess the only caveat I would put on there about retaining is sometimes in the past in the narratives of the reports, the authors of the reports have started putting in interpretations in there, and evaluations of the data. And I would prefer that just the data be presented and let the reader make their own interpretations.
DR. YOUNGMAN: Thank you very much for your comments. Awa.
DR. AIDARA-KANE: Thank you. So I think that there is a need to harmonize between the three arms in terms of availability of the reports. And also, in terms of reporting system and reporting format.
At retail, I think that having the species specified can be useful. And also, I think that it is important to consider having an integrated surveillance report. And to publish a collaborative report and use it -- this can be used to advocate for prudent use of antimicrobials in food animals. I think that it is important to have an overall picture of what is going on at farm level in human and animals to advocate for this.
And maybe in order to have this done more easily, it could be interesting to consider having a NARMS coordinator nominated by the three agencies to work on this issue.
DR. YOUNGMAN: Thank you very much for your comments. Scott.
DR. MCEWEN: I liked some of the things that I heard about the improvements that are expected in the NARMS Report. I think now, we currently have reports on the parts, the components of NARMS, but I think it is bigger than just the sum of the parts. I think you should shoot for a much more integrated consolidated report that covers the various branches of NARMS.
So, some of the words that came to mind would be consolidate, integrate, synthesize. I think we do need to have some interpretive summaries there. I think the part of surveillance is analysis and interpretation of data. So I think in the past, we have kind of thrown out lots of data, but the missing bit, I think, have been attempts to analyze it, interpret it, in an appropriate manner and using appropriate techniques involving, again, more sophisticated statistical analysis and trend analysis where possible.
I think that there should be a report which is readable, more narrative. As many of these comments we have made to the CDC -- review last summer, I think they are appropriate here. It should be more readable and sort of -- I think it would have much more of an impact in delivering on the goals and objectives of NARMS and reaching out to the users of the information.
I think you should consider subjecting the reports to peer review. I know that would slow things down. We don’t want to do that, we want to maintain timeliness. But sort of a short turn-around review, I think, would be helpful. I think when we are all preparing our papers and so on, if you know it is going to be critiqued by someone else, that helps you sharpen the things you say.
I agree with the comments that the availability of a searchable database for stakeholders would be a major plus.
DR. YOUNGMAN: Thank you very much. Okay, Marissa.
DR. MILLER: In a large part, I agree, again, with all the other excellent comments. To have an integrative report, I think it is critical. I think it was CDC that stated that they have a six-month goal. A goal to have the data out within six months. I think, you know, that should be a goal for all the arms in this integrated report.
I think it would be helpful to have an executive summary that is released as soon as possible, that can stand alone. And, again, that is for policymakers and others that may want to have a sense of what the findings are.
I wonder if it might be helpful to go back and look at DANMAP and what Denmark is doing as far as their reporting. Because in my mind, they have the most functional system in terms of enlightening public health and policy activities. So there might be some lessons to learn from how they do their reporting and generating of data. I like the enhancements that Paula spoke to about the trend analysis and web-based queries. I think if you can move in that direction, that would certainly increase the usefulness of the data to both folks inside the government and outside.
DR. YOUNGMAN: Thank you very much. Sue.
DR. KOTARSKI: I guess I will just add to the comments that were already provided by the reviewers. That it is a great body of information to summarize, so the aspect of trying to provide one report for all the information at the same time would be an awesome goal. Everybody wants it, I guess, but that is something for the future. I think that would be a difficult one.
In any event, I also like the aspect of seeing the MIC distributions. Those summaries come across. I think that is very useful because as breakpoints change by NCCLS standards, or you are using different screening mechanisms to detect a change in susceptibility, those distributions are very helpful and they last the long-term. So I commend you for putting them in when you can.
I like the idea of seeing the patterns of resistance if you are seeing -- to have that listing. I think it is very useful for your audience as well.
More context regarding the data. For example, the sampling strategy. How the sampling strategy changed from one year to the next. The limitations and the biases in the data. That stated explicitly helps those that are trying to use the interactive database, if you will, for their own purposes.
At least you have there in writing what those biases are, how those biases have changed, and it allows you public statement as to the extent to which you can examine temporal trends. Because, heretofore, in many of the cases of the different aspects of the NARMS, the sampling strategy has changed as just as a process of developing the system.
So maybe in the future, it will be systematic for the long-term and that won’t be necessary. But at this point, that would be useful for the reader.
Another aspect that comes up is the updates. As best as we can QC all of our results, we do find errors. And when we find those errors, we provide those updates. It seems that the CDC updates it in terms of the latest report provides the most accurate set of data. For the USDA, the NARMS, the USDA reports there was a period in which the website said, we have changed some of the database, watch out for “X,Y,Z.”
Either one can be effective but, explicitly, I would like to see on the websites, and in the reports, how you update it so that the reader can use the most accurate information and knows where to find the latest and greatest versions. Because there will be errors, and there will continue to be errors, it is the nature of the beast.
And, I guess, I would add too, just to emphasize, that some information about the nature of the sampling would be very useful in the text, and the summaries as well.
DR. YOUNGMAN: Thank you very much. Sean, your comments.
DR. ALTEKRUSE: The three arms of NARMS, they meet on an ongoing basis to discuss the reporting process. And I think that is really helpful. If they can use that to identify some consensus issues that they want to address, it is really helpful.
In particular, I agree with what Lyle suggested, and that is that by serotype information is valuable. Because there are thousands of serotypes and they have unique niches and so, in particular, the serotypes that I would recommend emphasizing are those top ten serotypes in people.
They are, actually, the top 20 serotypes in people, but overlaid with the ones that are found in meat and poultry, you come up with a list of about 10. That is Typhimurium, Enteradidus, Newport, Heidleburg, St. Paul, Monovadao, Thompson, Agona, Hadar and Redding.
There was a chart in Elvira’s presentation that I thought was really helpful. It showed the human isolates and their MICs by serotype as sort of a referent group. And then it showed the meat from retail in that serotype. And then, again, the meat at slaughter for that serotype.
So if that could be repeated, then you would have serotype-specific information and you can sort of see if the human isolates look similar in terms of their resistance patterns to what is being found in each commodity group.
Also, one last thing is that I think in addition to collapsing the HACCP isolates by what is called slaughter class, it would be helpful to expand it out so that ground beef and young cattle and older cattle are shown separately. Because that data should exist. And they may have very different characteristics. The serotypes coming from those categories.
Similarly, ground chicken versus chicken carcases and ground turkey versus turkey carcases. There is some value in keeping those separate. Okay.
Panelist Comments
Question Four
DR. YOUNGMAN: Thank you for your comments.
If we can now consider question four. What are the top three elements of a well-coordinated collaboration for the molecular characterization of isolates from all three arms so that we can demonstrate or refute a continuum from animal, food and human origins for specific pathogens and/or resistant phenotypes? Do you want to start with that, Lyle?
DR. VOGEL: I will try. Take what I say with a large grain of salt. I am not a microbiologist, and I am a long way from being a molecular biologist. But I will try.
What are the top three elements? I would say a linkage to epidemiologic information, for number one. Linkage to epidemiologic information for number two. And the same for number three. So I think it is extremely important that we gather epidemiologic information in order to make these -- either to demonstrate or refute the continuum. And somehow, we need to get back to the on-farm sampling as well.
DR. YOUNGMAN: Just so I am clear, when you say linkage to the epidemiological information, are you saying that things that link it to human disease?
DR. VOGEL: Yes. Was their human disease involved for the animal isolates. You know, especially, on-farm. Was their antibiotic use on those farms, et cetera. That type of information.
DR. YOUNGMAN: Thank you for your comments. Awa.
DR. AIDARA-KANE: --- standardization of methodologies and --- of numbering of the PFGE patterns, and timely information sharing. And I also put that linking of typing to other epidemiologic data is important. An important issue to track outbreaks. So epidemiologic also.
DR. YOUNGMAN: Thank you for your comments. Scott.
DR. MCEWEN: I think as Tim and Tom outlined yesterday, there was a lot of discussion about this area in the CDC review, so I would just make a note of that. I think it is relevant to the other arms as well; at least, some of those comments and recommendations. So just to make a couple of suggestions further to that.
Again, I think it is important to be strategic in the use of the resources available for characterization and concentrate on those efforts where NARMS is in the best position to make an impact. And then try to rely on collaborators in academia, or elsewhere, for some specific things. And, again, that was mentioned in the CDC review.
I think it is important to link the efforts. The efforts have to be relevant to human health outcomes, and I think we should try to be broad in all those sort of things that contribute to the burden of illness; not just resistance and treatment failure, but explore some of the other possibilities, including links between resistance and virulence of pathogens.
And, especially, the thing that I think needs attention is better understanding of the role of commensal populations as reservoirs of determinants and explore opportunities for trying to estimate the amount and type of transfer there is of genetic determinants among species of bacteria to human pathogens.
And not just enteric pathogens, but possibly other pathogens. I think that is an issue that kind of simmers in the background and doesn’t get enough opportunity. I think NARMS, with its very rich database of isolates. And, prudentially, epidemiological information, as Lyle has said, is in an excellent position to contribute to that. If not, be the sole investigator at least provide those opportunities for others.
I am not, sort of, ranking mine in threes because I am not, again, a microbiologist. I did have some questions about the extent of efforts in PFGE. But, I think, in answer to the questions yesterday, the group showed that that information is potentially useful, so let’s see how that goes.
DR. YOUNGMAN: Thank you very much. Marissa.
DR. MILLER: My understanding of the molecular characterization program currently in NARMS is utilization of pulse-field gel electrophoresis, and linking through PulseNet. So that is the strategy, as I understand it. And I think that was the opportunity presented to the government, and it has a lot of advantages. It has some disadvantages.
I think that Paula pointed out, and I really do agree with her, that there is going to be an evolution over time. And with the hope in my mind that there is movement towards a micro-array system, ultimately. And as long as everyone is sort of thinking about the future as you deal with the present, I think you will be prepared.
So, in just then thinking about the PulseNet system, I think the number one element that I would put forward is all the isolates from all three arms need to go in in a timely way and be available to everyone for interpretation. That is critical. My understanding is you are moving in that direction and, ultimately, that will happen. And, probably, in the near future.
I think that the second element is that the interpretation needs to be done in concert with the three entities. And that is important that there is discussion, and it is not just another generation of data that is out there. But that there is secondary hypotheses that are formulated. So there is a thought process about what is going on that leads to either field studies, or other collaborations, or other data analysis.
And good examples are the ones that were provided, I think, by CDC of working with David Hooper and Fred Tannover to drill down to that next level and try to figure out what is really going on. And why that is so critical is that PulseField really is a quick look-see that is very useful for outbreak investigations, but beyond that, it doesn’t tell you much. So you have to take it that next step.
DR. YOUNGMAN: Thank you very much. Sue.
DR. KOTARSKI: I don’t know if my background qualifies me as an expert to comment on this, but I will try as best as I can. I have a question about the question. And that is, it says, so that we can -- what are the top three elements of well-coordinated collaboration for the molecular characterization isolates from all three arms?
So that we can demonstrate or refute a continuum from food and human origins for specific pathogens and/or resistance phenotypes. And if I look at the question I can say, well, is that the objective is to refute a continuum or demonstrate a continuum. And I got kind of confused. Well, is this another objective we would like to have as a focus.
So I just offer the question, I was a little confused by that. Maybe you can help me a little on that.
DR. YOUNGMAN: I wasn’t one of the ones that helped to formulate the question, but to my take on this question is, what are the aspects of our molecular characterization research programs that are the most helpful in looking at foodborne disease? What are the things that work the best, in your opinion?
DR. KOTARSKI: Okay. Well, thank you. Again, from my limited understanding, I am very impressed with the fact that you do have the PulseNet system and the opportunity to forge you to quickly go through your different isolates and identify matches, if you will. I think that is a strength and is something that should be supported.
I think another element of that though is an integrated sampling strategy. We have an integrated sampling strategy from human illness, the FoodNet system, and the retail sampling strategy. And then we have another integrated system of sampling, which is in the CAFSHE.
And then we have the NAHMS Program, which is a different sampling strategy than the CAHFSE or the FoodNet and the retail. So they are not completely integrated, but you can take advantage to which each system has its own integrations. You have it with the VetNet and the PulseNet.
The fact that you have good standardization among the different programs is also a top element of that. It allows you to identify isolates that are identical and allows you a platform then to identify whether or not there is an epidemiological link.
But to use that as a major objective, I am not sure that is really the nature of the program, or if, in fact, that -- I am getting a little confused as to -- like I say, I come back to my original thing, what is the point of the question.
But I think that to have the integrated sampling would be very useful to enhance the PulseNet system that you have. And the standardization that you already have, or are putting into place.
DR. YOUNGMAN: Thank you very much for your comments. Sean.
DR. ALTEKRUSE: Well, I would say that the system should be transparent. That is something that Marissa said. I will get back -- transparent and that it should be useful by a variety of laboratories for comparisons. And then third, it should evolve with technology. But I would like to go into what I mean by those things.
In terms of transparency, queries should be possible across all three parts of it, and those will allow exploration of similar patterns that can be useful for deciding about field studies, or case control studies, or on-farm studies, whatever the case might be. And then going one step further for confirming those results in terms of finding a pathogenic bacteria in the environment where the studies would suggest you might find it.
So there needs to be an openness across the three systems to allow comparisons. And then the second thing is that not all laboratories are going to be as sophisticated as the three arms of NARMS are. Sometimes we will want to do comparisons with a laboratory in Thailand, or something like that. So it is not always possible to go with the very best technology.
Because as Shaohua pointed out yesterday, a laboratory in another location may not have a sequencer available for the purpose of comparisons. So for the time being, I do think that PFGE is something of the standard. Each of the presentations mentioned micro-array platforms that they were developing.
And I would encourage the three groups to consult on that so that they have a really well-defined set of resistance genes, pathogenicity, island genes, maybe somatic and flagella antigens. Because these micro-array platforms allow tens of thousands of oligo- nucleotides to be screened simultaneously.
So that is much more powerful than a banding technique for comparisons. And once the platform is established, it allows for high throughput and at very low cost. The cost of these chips is probably in the range of $5.00 to $10.00. But there is a research and development, and consensus building process that has to go on. That is sort of the evolution of new technology.
Panelist Comments
Question Five
DR. YOUNGMAN: Thank you.
Now, if we can move to the next question, question five. Currently, there are global efforts in health and food security relating to antimicrobial resistance surveillance. How should NARMS be involved in international efforts? Can we start with you, Lyle?
DR. VOGEL: Sure. First off, I would like to commend all three arms of NARMS for the efforts that they have had in international cooperation and the attempts for international standardization and international assistance.
With that said -- and I better move away from my colleague here to my right from WHO -- I do think in the time of constraints for funding and other resources, that this is one area that we really need to look closely at a potential way where we need to cut funding. And the amount of attention that we are giving to international efforts.
It is important but, to me, it is not one of the top priorities of a national antimicrobial resistance monitoring system. So I don’t believe that funding for international efforts should come from a national program.
DR. YOUNGMAN: Thank you for your comments. Awa.
DR. AIDARA-KANE: Thank you. So I would like to say that WHO, FAO, and OIE, on request from Codex Alimentarius Commission are currently examining the issue of antimicrobial resistance arising from antimicrobial use in animals intended for food. So I think that NARMS is very important program for all these international organizations. And this integrated surveillance will help development of food safety standards and antimicrobial resistant management strategies.
WHO urges members states to implement antimicrobial surveillance system to first implement sound public health interventions, and also to enhance prudent practices in human and veterinary medicine.
And as some of the speakers have already said, foodborne diseases need to be addressed globally. So I think that there is no sense protecting your national public health if you don’t look at what is going on globally. I think that participating to a global effort is someway also participating in your national improvement of your public health.
So I have to say that NARMS should join other existing networks, like DANMAP, CIPARS from Canada, to share information. For example, emergence of multi-resistant material. We have already had international outbreaks. It is only through information sharing between existing network that we were able to trace the origin of international outbreaks. It is also a good way to coordinate and harmonize the format of data reporting at international level, which would be very helpful.
And I am also here to encourage NARMS to continue supporting the work of international organizations involved in foodborne surveillance in terms of training scientists, in terms of activities of Global Salm-Surv, and also other networks, like Resistvet Project in Mexico and other existing networks.
DR. YOUNGMAN: Thank you very much. Scott.
DR. MCEWEN: Yes, I would also like to commend the various branches for their international efforts. I think it is very important. I think NARMS really is kind of a goal standard and needs to continue to show leadership and help other countries get on-side. I think it has provided some excellent examples of where this has been positive, as is the support and collaboration with WHO and other international organizations.
I agree that AMR is a global problem, and we need global efforts to confront the problem. I think as one of the slides showed, that bacteria don’t respect international borders. So I kind of think of the intelligence analogy where, if you have got threats abroad, you need to have intelligence gathering efforts abroad.
So I would look at the development of these other national programs beyond the U.S. borders as part of that information gathering. So I think it does serve a national interest, United States. So, again, I would encourage participation. And it didn’t seem to me to be a large expenditure for the return on investment.
DR. YOUNGMAN: Thank you. Marissa.
DR. MILLER: I guess I have to jump on that last point, because for an investment of $100,000.00, there is a remarkable scope of activities that I think are very important. And I would, certainly, support continuing in the international global arena.
I think that it is important on a lot of levels. One is for predicting what may be headed our way. Obviously, DT104 is a good example of that. And there is just recently a very, very compelling story about -- it doesn’t relate to enteric pathogens, but the use of Amantidine in China for bird flu, which has made the emerging pandemic strain resistant to one of our first lines of therapies. So, I think we just have to know and be involved in what is going on around us.
And I think it is wonderful that NARMS has had a leadership role, and I would hope that that continues. I agree that NARMS is a goal standard. And, I would say, to me, the three most important areas are training, which sounds like you are fully engaged, standardization of lab methods, and reporting. So I think for the small investment, the wealth of information and collaborations that have resulted are well worth it.
DR. YOUNGMAN: Thank you very much. Sue.
DR. KOTARSKI: Yes, I would also like to underscore the comments for the relatively small investment, the extent to which it is played out in terms of our outreach programs. The involvement in the PulseNet. It is the ability to take them on a passive basis -- incomings, if you will, as the examples that Shaohua gave us today. I think that it is all worth it.
On the surface you say, well, it is a national antimicrobial resistance monitoring program. And from that standpoint, one might question whether or not the monies that are spent should be under the NARMS funding. But that is beyond my decision-making, or my recommendations.
So the question would come up but, obviously, going back to the concept that bacteria have no borders, pathogens have no borders, for our public health surveillance, it certainly is essential.
I do have a question as to whether or not we can -- for the investment we spend in Mexico for monitoring or setting up a surveillance program there, or an integrated surveillance program there, how that influences our ability to help our own public interests, or the Mexican public interests. There wasn’t sufficient information for me to understand that, but I am confident it probably does. There wasn’t enough time, I am sure you could have told us all, but it was just a short time to go over it.
DR. YOUNGMAN: Okay, thank you. Sean.
DR. ALTEKRUSE: I agree that one of the legacies of NARMS will be its extension internationally. And the thing is that the interpretive criterion and the micro broth dilution methods -- all these methods are in place. That was a tremendous amount of work to establish these sort of standards.
And what that means is that by proving these resources to other countries, they don’t have to reinvent the wheel. So there is a leveraging effect by what has already been accomplished. And, therefore, I consider it really critical that the experts in the NARMS system continue to help with training and consultation on all of those aspects. On laboratory methods, quality control, troubleshooting.
It seems like we heard several times that some of the labs had difficulty with Campy at the outset. It sounds kine of familiar. And then on reporting systems, because that has been something that we have struggled with and it looks like we are getting to a good point with it.
Also, Tom mentioned some of the outside sources of funding. And if we can help cultivate those networks for funding -- he mentioned the World Bank, the Japanese agency, local sort of -- what do they call it -- micro-economic -- micro-loans, and other creative methods. That is really worthwhile.
DR. YOUNGMAN: Thank you very much.
We are at our last question, and then I would like to open it up for general comments, if I could. So if we could finish off with the last question, which is, NARMS is funded by FDA through inter-agency agreements with CDC and USDA. For the next several budget cycles, it is unlikely that funding for NARMS will be increased. In fact, it is likely it is going to be decreased. How do you suggest that we enhance and sustain funding for NARMS? And if I can start with you, Lyle.
DR. VOGEL: Sure. From the viewpoint of an organization that has gone by itself -- that organization being AVMA -- by itself to Congress to obtain and support funding for the FDA total budget, as well as specifically for NARMS budget. And also, as a member of the Animal Agriculture Coalition.
I think one of the ways that we can enhance and sustain funding for NARMS is to ensure that we maintain and improve stakeholder buy-in into NARMS. Stakeholders that we deal with are supportive, but with some concerns. So we need to improve that buy-in from the stakeholders.
Some of the concerns that have been expressed in the past are the fact that one arm of NARMS saw decreased funding over a period of time, while other NARMS were having increased funding. And that caused concern with the stakeholders.
One of the ways I think that we can improve buy-in of stakeholders is the oversight committee that was mentioned in the CDC panel review, that there be an oversight group of experts to meet periodically to --- the list, to evaluate the whole total NARMS program, and to provide advice.
You know, receive information about what is going on with NARMS, with the budget, with other aspects, and then to provide scientific advice to NARMS. I think if that such an oversight group was created, and the stakeholders had an opportunity either to sit on that group, or to provide nominees for that group, I think that would improve the stakeholder comfort with the programs.
DR. YOUNGMAN: Thank you very much. Awa.
DR. AIDARA-KANE: Yes, I have also noted the stakeholder’s participation should be improved maybe by sharing some success stories, or using data from the three arms of NARMS for advocacy.
And also, another point is maybe NARMS should consider having a steering committee with representatives from the three agencies, but also from all stakeholders. And one of the terms of reference of this steering committee may be, for example, fund-raising.
DR. YOUNGMAN: Thank you very much. Scott.
DR. MCEWEN: Yes, I found this kind of the toughest question. And I would just like to thank Dr. Sundlof for making it harder by saying we should also suggest how it could be even better. But I think that was a very wise request because funding does go in cycles. And while there needs to be some short-term belt tightening, hopefully, things will be better down the road. So we need to keep that in mind.
I guess general suggestions would be -- and it has been said many times, we need to revisit and tighten the objectives and use those as a basis for prioritizing activities and sort of -- hopefully, there won’t be things, actually, that fall off the table. That, hopefully, there will be some things that maybe can be cut back, but kept alive I guess until anticipating that there will be more opportunities for support down the road. So there is a maintenance of at least a presence in some of these other areas in the meantime.
It seems to me a core activity is monitoring of susceptibility and representative isolates of key foodborne pathogens, Salmonella and campylobacter in humans, food animals, and food. And I think we have to maintain that as a core.
I think it is important to retain some flexibility in the budget for various types of pilot studies and sort of investigations into other areas. I think those types of things tend to be trimmed in periods of physical crises, but I think that is -- and lots of examples provided in the last couple of days where those pilot studies have yielded useful information. So, try to retain some of that flexibility.
And, where possible, to try to deal with the question in front of us to continue to partner with other organizations. Again, to leverage opportunities where they exist. And, again, it made good use of that. There may be some others that can be taken advantage of.
Where possible, broaden the collaboration outside of government, to academia and elsewhere, to help fulfill some of the objectives of NARMS. I think, again, to expand on the example provided with CDC’s collaboration.
And I know that the other branches do this as well, but where the opportunities arise, to provide NARMS data and isolates to willing researchers and graduate students who may be funded from other sources. That is an opportunity to meet objectives, again, but have it paid for by other sources sometimes.
I guess, you know, if push came to shove, if I had to identify some things, I guess I -- again, I mention what I see is the core. Obviously, there is questions about cutting back on some of the commensal testing if necessary.
Maybe be more strategic, at least, with some of the characterization studies. I guess I wonder whether the return on investment of the Vet diagnostic isolates is there. And the usefulness of some of the isolates from compliance testing.
In answer to Dr. Sundlof’s request for some thoughts about how NARMS could be made even better, given an opportunity -- I think it has been mentioned already -- but I think try to make it more comprehensive in its representation of the farm-to-fork continuum.
So much more presence on the farm, and at other levels of the continuum. And, obviously, then try to integrate that information. A big, big challenge, but it needs to be met.
I think the system could do a lot to be more robust and statistically valid. And that is going to require a stepping up of sampling. I think another thing to consider is to broaden the range of antimicrobial resistance issues beyond purely animal, and its impact on humans to animal health issues. And, eventually, perhaps, embrace other, more purely human health issues and resistance.
I think design a system to better address issues of attribution. The contribution made by antimicrobial use in various animal species on impacts in human health, I think we need to get a much better handle on that.
Get a better handle on the issue I have already mentioned, the impact of resistance and sort of non-target, or non-pathogen species, commensal species, and their role as reservoirs of resistance.
A system that is better able to measure the impact of co-selection. And I think that is an important issue that is under estimated. And a better capacity to link NARMS with other important databases, such as human health databases, animal health databases. And, again, in the spirit of helping us to better address the main objectives of NARMS and measure impacts on human health.
I think there could be capacity for broader input of scientists from outside of the agencies. And if we had a blank check, to have capacity for research grants and fellowships that would encourage members of academia to make more use of NARMS data and help fulfill NARMS objectives would be beneficial.
And a point I will mention later is I think we need to include antimicrobial use in different ways. The farm level, aggregate, measures of use, and that sort of thing, to address NARMS objectives.
DR. YOUNGMAN: Thank you very much. Marissa.
DR. MILLER: I have just a couple of thoughts. First of all, I think there is a remarkable amount of productivity for the $5 million investment. At least what was the dollars that were presented to us. So bravo, good job.
And I know that it was mentioned, the leveraging off of other resources; which, obviously, will need to continue and be expanded as appropriate. Especially, in lean budget years. I think what you are not really taking into consideration are many hidden costs.
And, I wonder if it might be worthwhile to look at those. In other words, the true costs of running these programs so you would build in personnel costs, travel, training, the provision of isolates. Other things that happen that aren’t a line item in the budget.
And the reason I bring this up is it might help you justify continued funding it at your current level -- or, hopefully, slightly higher -- if you show the resources that go into it that aren’t being asked for. Just a thought.
I also will bring up once again an idea. It may not be viable but, perhaps, it can be explored. Because NARMS is really providing a post-marketing monitoring strategy for the center and, in essence, covering quite a few industry sponsors and industry groups, I think that, perhaps, there could be a justification for asking industry to pay into the system if it comes down to it.
I don’t know how this could work out, but I just throw that out; particularly, because of CDER’s requirements. Similar requirements for post-marketing surveillance that are burdened by the sponsors themselves.
I agree with Dr. Vogel about rallying your constituency groups and your stakeholders. And I would suggest that it might be a good time to bring those groups in into a forum similar to this where you ask for feedback, get buy-in, allow some ownership, and then raise the funding issue with them as well. And that could help, again, building up steam for justifying more money, or the current funding levels. I guess that was all I had.
DR. YOUNGMAN: Thank you. Sue.
DR. KOTARSKI: Yes. I would like to echo the sentiments of Dr. Vogel and Dr. Miller about the possibilities for engaging the ag groups. It seems like there has been points in the discussions over the past day and a half that we are lacking that information about resistance associated with food animals. We only have the NARMS every five years for a particular commodity. And it would be useful to have that.
We do have available the CAHFSE Program, which is an example by which we can get integrated data, but that program needs to grow so it takes into account more commodities. So you have elements in the NARMS Program, and in the CAHFSE Program, where you have systematic sampling, national monitoring, and good examples of obtaining that data.
And, with the engagement of the ag industries, capitalize on that. Identify if you can take a portion of your NARMS money and invest that with those groups to enhance your ability to understand the resistance that you are seeing, or that is out there with respect to animals. Engage them, actively involve them, and developing and enhancing that program.
You have good example right now of that occurring. So it seems like there has been opportunity to have that happen by working with them. And I would encourage that.
And, perhaps, you could think about doing that at the expense of the diagnostic isolates. Ask yourself, what information are we getting from the diagnostic isolates, how are you using that information, are we using that information, could that be put towards the healthy animals instead rather than diagnostic animals. That is a process that I think the agency might want to consider.
DR. YOUNGMAN: Thank you very much. Sean.
DR. ALTEKRUSE: First, I think it would be helpful if each of the arms of the surveillance system defined what their core objectives were. We have heard that a lot. And then, if the three arms could develop sort of an integrated summary of what the overall objectives were, and work with their stakeholders -- and that has the potential to form a pretty unusual coalition, potentially, of the agricultural coalition, the American Public Health Association, drug companies.
So, as Marissa was pointing out, maybe they would support -- perhaps, they could provide funds, but they might also advocate on our behalf for post-marketing surveillance activities. Consumer groups, the American Society for Microbiology. There are a lot of constituents that have specific interests related to this.
And as Awa and Marissa mentioned, those people could be brought together in a sort of forum like this to talk about what commonalities they share and support us, I think it would go a long way towards getting the funding to continue this.
The other aspect is it may be that we could find some places that we could, at this point -- you know, nine years into the project -- where we could identify some aspects for belt tightening and some refinements. And if that could be incorporated in the sort of integrated objectives. I think each arm mentions some aspects that they might be willing to take a look at.
Listeria and vibrio isolates, diagnostic isolates, commensal isolates, and some slaughter isolates that belong to less than compelling serotypes, as examples. But, I believe that if this is packaged correctly, and a broad coalition is brought together, it is very possible to get funding for this project to continue.
DR. YOUNGMAN: Thank you very much.
Well, that finishes our six questions that we posed originally to be considered during this conference. Again, I want to thank everyone who presented, everyone who attended, and all of the panelists for your thoughtful comments. Thank you very much, we appreciate them.
I would now like to open it, I know we have very limited time. We were aiming to end by 12:00, which is about 10 minutes away. But if there are some additional over-arching comments that have nothing to do with the six original questions posed, I would like to open it up for general comments now. Scott.
DR. MCEWEN: Yes, I had a few that I thought were over-arching. Some of them we touched on already. I think, again, I just want to reiterate that I think NARMS is an excellent program and all the groups presented an impressive amount of information and effort that is just unbelievable. I think just keep up the good work.
It seems, perhaps, most obvious that there needs to be better integration of the three areas. There is a lot of that already happening, but there is always room for improvement. I think this cuts across all the things that we have talked about.
Goal setting, setting objectives, sampling issues, design issues, testing issues, data analysis and interpretation. So that is going to be tough in some ways, especially, when it gets to interpretation and summary reports. But I think that has to happen to be really effective.
It seems to me there are some management issues that need to be considered in order to achieve that. And I think a point was made a couple of times, that there needs to be better coordination. And it seems to me it probably calls for sort of one voice to champion NARMS and to have some decision-making capabilities.
So it seems to me that, given that funding comes from FDA and the major, kind of over-arching goal in my mind, at least, of NARMS is antimicrobial resistance and how animal use of drugs effects that, that FDA would be a -- that CVM would be a logical place for that.
So I think we need to have somebody who can sort of take on a leadership role. And it seems to me that since he is not here today, it is easy to say, somebody like Dave White would be kind of a good example of somebody to take that on. So I think that is something to consider.
I already mentioned, and others have, that we need to kind of look at the objectives. They will be sort of NARMS-wide objectives, and then sort of area-specific ones that should relate to those over-arching objectives.
I think, again, a missing component in all of this is antimicrobial use information in animals and in people. And that would be something to strive for.
DR. YOUNGMAN: Thank you very much. Are there other general comments that someone would like to make? Sue.
DR. KOTARSKI: I had mentioned it before, but I would like to echo the sentiment of a steering committee or an advisory committee to work through over the years as a stopping point to reflect. I think that that is a good idea.
DR. YOUNGMAN: Thank you.
DR. MILLER: I agree with that point, and I would ask that you extend it internationally as well so that you have international representation involved.
DR. YOUNGMAN: Thank you very much.
Okay, I guess that wraps up our comments. Again, thank you very much to all of the attendees, the presenters, and the panelists. Thank you for all of your comments, we really appreciate them. Thank you very much. Concluded-11:51am
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