LOU CARSON: I want to welcome you all here. Thank you for your participation ahead of time. We hope to have a very full and open public meeting and hearing your comments. Today each one of you should have picked up a green folder in the back which will have the materials as well as the agenda. If you have not, please pick one up in the back. We have additional agendas out at the registration desk if you need them. Today we're going to be starting here and just now we are going to go over an introduction. These are some of the administrative details that I'd like to remind you about. When you do speak, when you get up to speak and make a comment, if you would, identify yourself by name and affiliation. And the reason this is important is we have the two young ladies over there on the side who are taking this down as a transcript and we hope to have a transcript of this meeting that will be displayed on our web site in probably a few weeks. So it's important to hear your name and your affiliation so that we can link up to comment with that your person.
Let me just quickly go through the agenda. The agenda is laid out that we will have some brief background remarks from Judy Riggins and myself. Then we are going to go into a presentation from CDC on SE illness. And then we're going to go into the segments of the Egg Safety Action Plan. One thing that's changed from the agenda that you have before you, we will have a question and answer period right after the CDC presentation and I'd like you to note that there is a different speaker. Mary Evans will be speaking from CDC in that 8:45 slot. So immediately following her presentation, we will open the discussion for any questions or answers of the opening remarks and then the CDC presentation and then go into the next presentation. The way we're going to handle the presentations and the comments is that there will be a brief five to ten minute presentation of each segment such as on-farm production -- overview of the issues. And then we will ask our panelists to answer a few questions that we will have on the screen. And these questions were the ones that were in the federal registered document. That discussion period will be moderated by Marilyn Balmer in the morning, and Ms. Vicky Levine in the afternoon. And basically what they are going to be doing is trying to acknowledge people as they get to the microphone so that we don't have everyone trying to speak at the same time.
We will have a break around a little after 10:00. Again, the sessions will be up to an hour. If there are no other comments, then we will move on to the next section. So we do not need to hold each session for an hour if there are not sufficient comments. We will try to move the program forward. We will break for lunch approximately at 11:35, return in approximately an hour and start the afternoon program and repeat.
We have asked people if they wish to make a statement at the end of the meeting, to register. And Linda Russell out at the registration desk is taking names so we can just acknowledge certain people in an orderly fashion so that you can make statements. So if you wish to do so, please register out at the registration desk and then we'll acknowledge you after the meeting.
And then finally, at around 4:30, we will try to make some closing remarks. Those remarks will simply try to highlight those points that we've heard during the whole day of discussion. Are there any questions on how the meeting will be run? Okay. Judy.
JUDY RIGGINS: Good morning. You've met my colleague, Lou Carson, and I'm Judy Riggins from the U.S. Department of Agriculture in the office of policy. And I have a voice like Minnie Mouse so you'll have to bear with me here. Lou and I appreciate the opportunity this morning to welcome you on behalf of the Food Safety Council and the Task Force to our first of two public meetings.
The two departments, HHS and USDA are developing a farm-to-table approach to reduce the illnesses from salmonella enteritidis from shell egg and egg products. We appreciate the opportunity today to hear your thoughts, your concerns, and your comments on our current thinking for proposed rules for on-farm practices, shell-egg packing, and breaking and pasteurization facilities. Last year, the President's Food Safety Council initiated a process to develop a national strategic plan for food safety.
As a first step, the council identified egg safety as a public health issue that warranted immediate federal interagency action. The council established a Task Force that's co-chaired by Dr. Jane Henney, the commissioner of FDA, and Dr. Catherine Loteke the undersecretary for food safety at USDA.
Lou and I served as co-chairs for the Egg Working Group convened by the Task Force to draft an Egg Safety Action Plan which we published on December 10, 1999. The overarching goal of the Action Plan is to eliminate SE illnesses associated with egg consumption by 2010. The interim goal is a 50 percent reduction in egg-associated SE illnesses by 2005. The action plan is based on the SE Risk Assessment that indicated that multiple interventions can achieve a more substantial reduction in SE illnesses than using any one intervention alone. The Egg Safety Action Plan offers two equivalent SE reduction strategy to the industry each delivering eggs into distribution and to the consumer at an equivalent level of safety.
Egg producers and/or packer/processors will determine the point at which pathogen reduction steps will be taken. Pathogen reduction steps may be taken on the farm using SE testing and egg diversion and at the packer and/or processor with a "kill step" to eliminate SE. FSIS in cooperation with CDC, AMS, APHIS, and representatives from the states are drafting proposed regulations to address SE hazards on the farm at egg-packing facilities and in egg-pasteurization facilities. We published a March 21st Federal Registered Notice announcement of this meeting that requested comments on numerous questions related to our interagency coordinate egg rulemaking. We welcome your comments and request that you submit them to us by April 20th. Now Lou will talk to you in more detail about the Egg Safety Action Plan and it's two strategies.
LOU CARSON: The way the agenda is arranged is to try and give you the picture that the two strategies that Judy just talked about. One focuses on the farm and putting in preventive control systems. The other strategy focuses at the egg-processing segment that would apply whatever technology that would provide a "kill step" whether it's pasteurization or other, they need to deliver to the distribution chain the same safe eggs regardless of which pathway has been taken. And what this really means is that the pathway for both strategies require renewed emphasis at the farm, at the packer/processor, at the retail, and at the consumer level. Each strategy is built on each one of those as an interval element to achieve this reduction by 2005. And so our agenda today is arranged so that we are covering each one of those segments from farm-to-table. We recognize that we can do better at each level. In the back of the room, for example, we have put up the Fight Back Campaign which Fight BAC! is really targeted at consumers, but we are also looking at educational efforts at the retail level, at the packer/processor level, and at the farm production level. So we can, I think, make people more aware of what are the potential hazards of each one of the steps and where we might be able to make a difference in achieving our reduction goal of 50 percent by 2005.
Today, what we are trying to present to you are some of those elements at each one of those segments which we believe have a contribution. What we need to hear from each one of you is to what level you believe they can contribute and how best they can contribute. As Judy mentioned, we were charged by the Food Safety Council to come up with an Egg Safety Action Plan. This Action Plan required the coordination and cooperation of the agencies that Judy mentioned, APHIS, AMS, FSIS, CDC, and FDA. We continue to work together crafting our proposed rules, and we are working with a group of state officials that are assisting us in that regard. The time line that we have before us is this: We are charged with proposing rules by the end of this year and then allowing those for public comment, trying to finalize those rules the following year, and try to implement those standards in either 2002 or 2003. We would assume that there would be a phased-in approach so it would take more than one, probably one to two years to phase that in.
We need to achieve implementation by 2003 if we hope to be able to measure the success by 2005. So to measure whether we have achieved the goal of 50 percent reduction, we will have to have a plan in place, allow it to perform to see if that program is really deriving the benefits that we're trying to achieve. The next speaker, is Mary Evans from the Centers for Disease Control. We mention in our Egg Safety Action Plan that we were going to be using the baseline data from CDC as the starting point for trying to achieve our 50 percent reduction of SE illnesses. And what we would like for Mary to come up and talk a little bit about are those systems that we would be using to determine the incidence of SE illnesses and whether we are being successful.
MARY EVANS: Good morning. Today I would like to present an overview of the CDC surveillance data for salmonella serotype enteritidis infections in the United States. I'll begin with a short background about SE and continue with our laboratory-based active surveillance and SE-outbreak surveillance systems and then offer some short conclusions.
SE emerged in the Northeastern United States in the early 1980s and has since spread throughout the United States. Since 1993, SE has been the first or second most common salmonella serotype behind salmonella type venereum. Previous studies as well as outbreak investigations have shown that raw or undercooked eggs are the predominant vehicle of SE infection.
Culture-confirmed cases of salmonella are reported to CDC through the Public Health Laboratory Information System or what we call PHLIS. This slide shows the proportion of salmonella isolations from human sources that were SE between 1996 and 1998. As you can see from the graph, the proportion of SE has dramatically increased from 1996 reaching a high of 26 percent or approximately 98,000 on isolations in 1994. Since then, the isolation rate has fallen to 18 percent in 1998 representing approximately 6,000 culture-confirmed cases. This slide shows the SE isolation rate by region of the United States. And as you can see, the New England region shown in yellow and the Mid-Atlantic region shown in blue have historically had the highest rate of SE infection.
Although in recent years, both of these regions have fallen dramatically. Conversely, the Pacific region which is shown in green, while it has historically had low rates of infection, dramatically increased in the 1990s, but, again, this region has also fallen in 1998. The Food-Borne Diseases Active Surveillance Network, or FoodNet, is collaboration between CDC, FDA, USDA, and selected sites around the United States. And the purpose of FoodNet is to conduct active surveillance for various bacterial and parasitic pathogens including SE. In 1999 there were eight FoodNet sites which represented about 25 million population that was under surveillance.
Now, as you can see from FoodNet data, the rate of SE was approximately 2.5 per hundred thousand in 1996 and 1997. However, in 1998, we again saw a dramatic decline in the rates of SE in the FoodNet sites, about a 44 percent decline down to 1.4 per hundred thousand population. And as you can note from this slide, this graph is only based on the original FoodNet catchment area which was five sites.
Now, we know that for any culture-confirmed case of salmonella or any pathogen that's reported to CDC, many more cases go unreported. And this rate of under-reporting can be estimated and shown here by what we call the burden of foodborne illness pyramid. Along the base of the pyramid represents the general population. The next tier represents the people that actually become ill. Now a person may or may not decide to seek care for their illness. Their health care provider may or may not order a specimen to be tested. The lab to which the specimen is submitted may or may not test for all potential bacterial pathogens. A proportion of the specimens that are submitted will actually yield a pathogen and then a proportion of these culture-confirmed cases will actually be reported.
So FoodNet is unique in that it allows us through the act of surveillance and through the various surveys listed here, the laboratory survey, physician and population survey, to estimate the number of cases that occur along each level of the pyramid. From this we can create a multiplier that helps us to estimate the number of SE cases in the entire country. And the FoodNet multiplier that has been derived is 38. That is, for every one culture-confirmed case that you see at the top of the pyramid, it actually represents 38 cases in the general population.
Now, this model can be applied to SE to calculate the approximate numbers of SE that we would expect to see in the general population. We'll use, for example, the 1998 PHLIS data. There were 6,035 culture-confirmed cases reported in the United States. If we apply the FoodNet multiplier of 38, we can see that we estimate in 1998 there were approximately 230,000 cases of SE in the United States. Now, again, this is based on the 1998 data, and as you saw in previous slides, the rates have dramatically fallen. So, obviously if you would have based this on an earlier year, 1996 or 1997, the numbers would be a lot higher.
Now, we would expect from previous studies that a proportion of these cases would actually be associated with consuming raw or undercooked eggs. However, it's extremely difficult to calculate the exact number of these people who have eaten eggs because we don't have information of how individual people acquired their SE infection. Rather what we do have is information about vehicles in outbreak settings. And that's the information I would like to present to you now.
Since 1985 CDC has maintained an SE-outbreak surveillance system which is basically a system where we keep track of SE outbreaks that are reported around the United States, and as you can see we reached a high of approximately 82 outbreaks in 1990. Since then the numbers have fallen and, in recent years, have leveled off. And in 1999 there were 44 outbreaks reported from the entire United States. This slide, again, shows the outbreaks between '85 and 1999 and, as you can see, there have been a total of 842 outbreaks representing approximately 29,000 cases, 2,900 hospitalizations and 79 deaths. And it should be noted that the majority of these deaths occurred in people that were in hospitals and nursing homes.
This slide shows the SE outbreaks by region of the United States. It looks like the red line may be a little difficult to see, but that actually represents the Northeastern region which has historically had the greatest number of outbreaks. Although, in recent years, there has been a dramatic decline in the number of outbreaks in this region. Again, the Western region shown in green has dramatically increased in the early 1990s. And today this region represents half of the SE outbreaks we see in the entire country.
This slide shows the outbreaks of SE infections by location of food preparation. And, historically, over 60 percent of the outbreaks have involved foods that were prepared in a commercial venue. And by this I mean a restaurant, deli/bakery, or a catered event. Eleven percent have involved food prepared in health institutions, 13 percent in private homes, and 15 percent in other locations; for example, schools and churches.
This slide shows outbreaks by food vehicle. Now, historically, we've been able to determine a vehicle in outbreaks in only approximately 45 percent of outbreaks. And by "determine a vehicle" I mean that there was either a case control study or a cohort study done that statistically implicated that vehicle and/or we were able to isolate SE from a food source. However, of these outbreaks, 295 or 81 percent of them have involved foods that were egg associated, that contained eggs.
Now, if you want to translate this into numbers, we saw from the previous slide 842 outbreaks represented approximately 29,000 cases; 20,000 of these cases were in outbreaks where there was a confirmed vehicle; and 15,000 of these were egg-associated cases. Again, this is just based on outbreak data.
This slide shows the egg-associated vehicles by category, and I apologize for the slide being slightly cut off on the side, but you can see the proportion in green represents traditionally-prepared egg vehicles such as omelettes and egg-battered foods. That's been our highest percentage followed by desserts, sauces and dressings, and then pastas. So, in conclusion, we can say a couple of things. Based on our 1998 PHLIS numbers and applying our FoodNet multiplier, we can estimate that there are approximately 230,000 cases of SE in the United States at least for 1998.
Both our PHLIS and our FoodNet Surveillance have shown that there are nationwide declines in the number of SE cases. In terms of outbreaks, while there have been drastic declines in certain regions of the United States, particularly the Northeastern region, the number of outbreaks have remained relatively unchanged in the most recent years, like, '97, '98, and '99. However, with outbreaks with a known source, we know that the predominant vehicle remains raw or undercooked eggs.
So despite the declines in SE we think it is still a very important health problem that's going to require cooperation between public health officials and industry at all levels and an entire farm-to-table approach for prevention. Thank you.
MARILYN BALMER: Are there any questions at this point on the CDC data? Could you please go to a microphone.
KEN KLIPPEN: Good morning. My name is Ken Klippen and I'm with United Egg Association and United Egg Producers in Washington, D.C. And, Mary, I just have a question for you if you could help me with this. In the recent morbidity/mortality weekly report, dated March 17, 2000, it stated that, and I'll read it, that SE rates declined, salmonella enteritidis rates declined, 48 percent from 1996 to 1999 with a 7 percent decline from 1998 to 1999. Of course, the salmonella enteritidis is the one that we're most concerned with because that's the one that's associated with eggs.
Why is it declining? What programs have taken place to substantiate a fall in the SE rates?
MARY EVANS: That's a good question. I don't really have an answer for that. We only collect the data and monitor the trends. Maybe someone with the USTIT would have some better ideas about that.
JILL SNOWDON: Good morning. Jill Snowdon with the Egg Nutrition Center. The information that you put that you're collecting is on all salmonellosis from SE. So the program that we're looking at is salmonellosis from SE from eggs. So if we're talking about benchmarks and what we're going to use for the success of the program and also communicating to the media, because the media have trouble distinguishing between all salmonellosis cases, all SE cases aren't all associated with eggs.
Those little details tend to be important. Likewise, not all cases of salmonellosis, although a large majority are, are foodborne. So there's also -- the CDC estimates a 5 percent chunk that isn't even foodborne. So we need to make sure that we are even. If the program is directed at eggs then we need to be thinking about measuring the egg involvement with accurate, stable databases such as the salmonella surveillance system, such as PHLIS stated, that you put forward, such as FoodNet. Because it would be illogical and unsound scientifically and kind of put everybody in a vulnerable or unfair position if we're mixing the two. So it's very important to communicate when the data is representing salmonellosis, salmonellosis from SE, or SE-based salmonellosis associated with eggs.
The question to what extent outbreaks affect sporadic cases, particularly since outbreaks are -- What? -- less than 1 percent of all the cases across the United States in recent years, is another question that we've got to grapple with anybody looking at epidemiology and how we're going to use it. I mean, it's a tool. It's a great tool. But, again, I think we need to be very clear in our communication and very clear in our goal setting then as to what we're using as our benchmarks and are they accurate reflections of what the goal of the plan is.
Either that, or we expand the program to include more than eggs and just take care of all salmonellosis associated with SE. One or the other.
MARILYN BALMER: Okay. Let's progress into the main portion of the program. Okay. Darren.
DARREN MITCHELL: Darren Mitchell with Center for Science in the Public Interest in Washington, D.C. It sounds like CDC has not yet or won't track down what the source of the declines are. I'm not saying that figuratively, I'm just not sure that it's within your purview. Do the other agencies tend to look at, sort of, the regional declines and try to see whether, as the agencies have noted, and other groups have noted, successful quality assurance programs in places like Pennsylvania, are the source some of the declines?
LOU CARSON: Again, I think, the reason we are here today and talking about a farm-to-table approach, both FDA and USDA and CDC do believe that nationwide consistent standards reflecting the programs that certain states have already enacted, are certainly indicative of those kinds of preventive controls that will have a positive effect on reducing SE illnesses. So the Egg Safety Action Plan is certainly based on the history of what states in the Northeast and in the Central region have already taken.
The question you ask though goes to surveillance and making a direct connection. I think that is a very complex question. We certainly are going to attempt to survey and try to link wherever possible. We may not be able to directly link, but we will make that effort.
JUDY RIGGINS: I just wanted to add that research is a very important part of the Safety Action Plan. And we do intend each year to develop an agenda for research in cooperation with FDA, and ARS, AMS, and other agencies. Of course, CDC is central to that because we use the information from CDC to form the questions for our further research. So we do intend on an ongoing basis to determine what research needs we have each year and to refine the knowledge that we have.
Understand that we have to start where we are. We have to start someplace. So it is our intent to have that ongoing effort.
MARILYN BALMER: Okay. We have a panel today representing various parts of the industry, the public and the states. On the panel today, we have, starting on the left, or your right, Tad Gross, who is president of Hemmelgarn and is also president of the Ohio Poultry association and the Ohio Egg Processors Association. Next to him is Meryl Sosa who is with FACT, Food Animal Concerns Trust. She is manager of their food safety programs. Next to Meryl is Dave Glauer who is the state veterinarian for the State of Ohio.
These panel members will initiate discussions after each presentation. The first presentation will be given by Rebecca Buckner.
REBECCA BUCKNER: Good morning. I'm Rebecca Buckner and I'm with FDA's Office of Plant and Dairy Foods and Beverages. And this morning I'm going to give you a brief overview of some of the issues that FDA is considering for it's proposed rules On-farm SE Risk Reduction Control.
As you heard described earlier, the Egg Safety Action Plan outlines two strategies for reducing the risk of SE in eggs. I'm going to discuss a portion of Strategy I this morning. Strategy I focuses on on-farm controls, retail, and education for SE Risk Reduction. Later today there will be a presentation and discussion on the retail and education efforts. However, right now, I'm going to focus on the on-farm controls. Under the Egg Safety Action Plan, it is FDA's responsibility to develop consistent nationwide standards for on-farm preventive controls. We plan to implement the inspection and enforcement on the farm through state contracts.
FDA envisions that these consistent nationwide standards will consist of two parts. The Plan, or the SE Risk Reduction Plan, and the verification of that plan. The Plan is composed of the measures that will actually provide the risk reduction. The verification ensures that these provisions are, in fact, working effectively and providing risk reduction. Potential components of the Plan include purchasing chicks from SE-monitored breeders, biosecurity in which you would maybe limit visitors and not move equipment between houses and not allow stray poultry into your houses; also the use of SE-negative feed, cleaning and disinfection of houses and equipment, a rodent and pest control program, because we know that rodents and flies can harbor SE; a flock-health monitoring program and use of a monitored-water supply. And all of these provisions are aimed at reducing the production of SE contaminated eggs. And those would make up the SE Risk Reduction Plan.
The verification of this plan, FDA is considering perhaps the possibility of environmental testing and perhaps egg testing with diversion if the egg testing is positive. Verification is necessary to provide assurance that the components are actually effectively reducing SE. And that is a basic overview of these issues. My presentation is very short. That's the Plan as I have described it and it's potential that's under construction. We're developing a proposed rule at this point. So we are very interested in your input and, therefore, we have the following three questions for discussion this morning. And they relate to on-farm controls and I guess at this point I'm going to turn it back over to Marilyn to begin the discussion.
MARILYN BALMER: If we could start the discussion with those on the panel, the questions are: Are the following appropriate and adequate components for nationwide SE Reduction Plan. They are biosecurity, SE-negative feed, chicks from SE-monitored breeders, flock-health monitoring program, cleaning and disinfecting of houses, rodent and pest control, and monitored water supply.
Let's start with the first question. Shall we start with Tad on the end?
TAD GROSS: Well, my experience has mostly been with the program that we have developed in the State of Ohio here. I feel that all the above mentioned things have been put into place. In the Ohio program we have come along and started on a small basis and continued to modify as we went incorporating things with the help of the ODA to pick and choose what was brought to our attention.
For example, from UEP, they have a 5-Star Program and we've kind of worked off of that. The Pennsylvania situation is naturally one of the leaders in the Egg Quality Assurance Program. Ohio had nothing when we started. And we've worked to at least focus on something, got our producers working in the general directions. We have implicated all of the following things into this program. And at this point we feel it's come a long way and naturally improvements can be made as it goes.
MARILYN BALMER: Can we just move along? Meryl, if you have any comments?
MERYL SOSA: Of those elements, we, of course, feel that all of them are very important, but I'd like to focus for a minute on the requirements that there be SE-free chicks placed in the pullet house. Because even if a small percentage of salmonella-positive eggs enter the hatching cabinet, the spread of salmonella from these eggs can be extensive. Chicks are extremely susceptible to salmonella contamination because they do not develop immune systems until they are ten days old. In addition, hatchery contamination can limit the effectiveness of competitive exclusion products.
A study found that salmonella could be found inside the beaks of chicks which were still in the egg but ready to hatch. Here, also, competitive exclusion products would be ineffective since colonization had already occurred. Since it is not possible to totally prevent SE contamination in the chicks, testing of chick papers is a necessary component of the program.
And the other aspect regarding SE-free chicks that we would like to talk about for just a second is the idea of indemnification resulting from the SE-free chicks. Because if the producer tests the chick papers on delivery and finds that the chicks are contaminated, then the breeder should be required to provide a new batch of uncontaminated chicks. Currently breeders do not maintain extra stocks of chicks for such emergencies. Instead, if such an occurrence arises, the producer must order new chicks; and the flock houses must remain dormant thereby creating a financial hardship for the producer. Thus, if the breeder fails to provide replacement chicks then it should be required to financially indemnify the producer for any losses incurred as a result of the inability to commence the flock in a timely fashion.
And I would like to note that while I am the manager of Food Safety Programs, and FACT is an advocacy organization, we also have a subsidiary called Nest Eggs. And Nest Eggs is a producer of eggs from uncaged, drug-free hens. And we have been implementing an SE program since 1991 on our farms. And our farms have been in existence since 1984. So we do speak from sort of both sides.
MARILYN BALMER: Dave.
DAVID GLAUER: Thank you, Marilyn. Just a brief diversion from the program just to welcome to all of you to the State of Ohio. We are pleased that you are here.
From Ohio's standpoint, we did begin work back in 1996 relevant to salmonella enteritidis issues in eggs, and we have reviewed a variety of different state programs and feel that we have put together a program that encompasses the individual segments of a program that you've seen on the screen before, and that are listed here in that program.
We feel that in following those and developing those best-management plans on the farm that we do have the ability to put in place a program that will help reduce SE in the egg.
MARILYN BALMER: Okay. In the audience and around the table, I know there are representatives from other states, other producers. The floor is open for any comment. Can we start with the table first?
DARREN MITCHELL: Hi, Darren Mitchell with CSPI again. I just have a couple of comments on this portion of the plan. First of all, to CSPI, the most important element of this entire Egg Safety Plan is a successful testing and diversion plan for producers/processors who aren't going to rely on a "kill step". And there aren't any specific -- I guess we may get to it in Question No. 6 -- What I assume is that the agencies, while during rulemaking, hash out whether the testing should be focused on environmental only, environmental plus eggs, there's some combination that makes sense. But we would like to see a lot of emphasis on that discussion and we would like the rulemaking to be focused on that in large part. In terms of what is listed, we also agree that every single one of those components is critical and we have a couple of enlargements or additions as well.
One is that -- and I'm not sure this is the appropriate place to put it, but enforcement, obviously, is critical. And I'm not sure that we're going to talk about enforcement in the other questions, but if the state agencies are going to be responsible for enforcement, we'd like to see very, very strong federal oversight to the extent that the federal government preapproves or preaudits the state enforcement program and then conducts regular, preferably annual, audits of those programs to ensure that the state agencies are doing a good job. The need to disinfect and clean, obviously, is critical and we would like to see SE testing as a means to ensure that the cleaning and disinfection is actually successful.
We haven't addressed the issue of forced molting. For producers who rely on induced molt -- First of all, we would prefer to see that practice banned because of it's relationship to SE and the fact that it increases the colonization of hen intestines with SE and can also increase shedding. But to the extent that it's not prohibited, we'd like to see extra measures in place to make sure that flocks that are induced, that have induced molting, are tested to ensure that SE is not being shed.
And finally, we think it's important -- we talked about SE-free chicks -- SE-free pullets prior to placement in the pullet house, we think, is also a critical element. So I'll leave it at that. Thank you.
MARILYN BALMER: Anybody else from the table? Meryl.
MERYL SOSA: I'd like to elaborate on what Darren mentioned about forced molting since it's not mentioned as one of the elements there and I don't see it mentioned under any of the other two questions. As you are probably all aware, we do not force molt on our farms. The Risk Assessment stated that 22 percent of flocks producing eggs on any given day are flocks that were previously molted. And we feel that this figure underestimates the extent of the practice. In fact, according to the recently completed NARMS study, 82.6 percent of all egg farms routinely molt their layers. The West force molts 94.9 percent of it's flocks. Further, 32.1 percent of the last completed flocks in the West were force molted twice.
As more consumers have become aware of this practice which is both inhumane and hazardous to the public health, the issue is now being raised at the state level. In California there is now a bill pending in the legislature to prohibit this practice. The Plan calls for, quote, a consistent nationwide program that addresses each stage of the farm-to-table continuum, close quote. Thus, if the issue of forced molting is not addressed in the Plan, then individual states may start enacting prohibition on the practice which will defeat the concept of a consistent nationwide program.
I just want to mention also that the SE Risk Assessment demonstrates the need for testing especially on large farms. The Risk Assessment found that by flock size strata, the largest stratum, flock sizes of 100,000 per flock, contributed almost two-thirds of SE-positive eggs. And finally, in terms of the test itself, FACT supports environmental testing over testing batches of eggs. Environmental tests provide a more accurate picture of whether or not the flock is contaminated. Infected hens do not produce contaminated eggs all the time. Furthermore, not all hens at a flock house are infected by SE at the same time. Therefore, testing batches of eggs will not provide sufficient evidence to determine whether the flock house is contaminated by SE. On the other hand, since infected hens will shed SE, environmental samples provide greater certainty as to whether SE is present in the hens.
So as a final note regarding forced molting, if the Plan does not include a prohibition from the practice -- which, of course, we feel it should -- then at a minimum, mandatory post-molt environmental tests should be required as part of the Plan.
MARILYN BALMER: Anybody else at the table? Okay. Can we start with the floor?
RITCHIE LAYMON: Thank you. My name is Ritchie Laymon. I'm from Columbus, but I'm representing United Poultry Concerns which is located the Del Marva area. And I am so glad the two panelists noticed that glaring omission. That was the first thing that jumped out at me is there was no mention of a stoppage of forced molting. When Mary Evans said in her introductory speech that there was a dramatic increase in SE in the Pacific region, I immediately thought of California being number one, at one time, in the production of eggs and the fact that they used forced molting on tens of millions of chickens every year. And I would have thought that CDC would look immediately at that connection since we know there is a connection between SE and forced molting. And that spike in the Pacific I would think would be directly related to that.
And another point, I want to make a vow to necessity to stopping forced molting because with the graying of America you have so many elderly people who eat eggs. It's an easy food to eat for them. I think you're going to see an increase. I think this trend to go down will go back up again. And also something as simple as the Atkin's Diet which asks people to eat bacon and eggs, you're going to see an increase, I think, in that area too. Anyway, I would like the CDC to respond a little bit if there was any research done on forced molting and SE and the spike in the Pacific area?
MARY EVANS: I'm not aware of any research that's currently going on, but that's certainly an interesting question that we could look at.
MARILYN BALMER: Other comments from the audience?
ALICE WALTERS: Hi, I'm Alice Walters, the executive director of the Ohio Poultry Association. My comment on forced molting would be we have a program here that will also affect small, medium, and large producers. Our larger producers may be able to stop force molting but I seriously doubt that our small and medium producers would be able at this point in time to incur the economic losses that would occur if the federal government does a total ban on forced molting. I'm sure there's some other producers in the room that would state that.
So if you are concerned about the smaller family farmer, you need to take this into consideration at this point in time. We do have other mechanisms available to us and we are using them currently in Ohio. And that is the environmental testing of the manure. We are not seeing at this point, and maybe Dave can correct me if I'm wrong, but most of the flocks force molted that are on our program and have been on our program since 1996, we're not seeing an increase in SE in those manure samples that are coming in through the Ohio Department of Agriculture Laboratory.
Also we have available to us the vaccines.
Bioimmune is one, and the Megan Vaccine, that we can also utilize at this point in time to treat our flocks here in Ohio. And I think there are some management tools available to us that can also be built into a program such as this. One other comment that I would like to make, and excuse me if I offend anyone, but I have a problem with this forum being a forum for animal rights agendas. And I know that Ms. Laymon is also with an animal rights organization that is very active against the poultry industry here in Ohio. And I would just like all of you to also weigh those comments in that regard. Thank you.
MARILYN BALMER: Bob.
BOB ECKROADE: Bob Eckroade from the University of Pennsylvania whose worked with the PEQAP Program there for many years. My guess is in Pennsylvania we molt at least 60 percent of the birds. And our program also requires testing post-molting, additional testing post-molting. And I can tell you that in the real world, there is absolutely no evidence that there's a great increase in the shedding of salmonella enteritidis in flocks that are monitored post-molting.
So while there's been some experimental evidence done by some good people, I think, as always, when you extrapolate that to the real world, it may not hold up. And I too think it's important to separate out the issues of animal rights and the issues of how best to control the shed of salmonella enteritidis and still allow our industry to make a profit and to run its own business.
MARILYN BALMER: If there are no more questions, let's move on to the second one that is: Is environmental testing an appropriate verification step to ensure that the Risk Reduction Plan is working? If so, how often and when should testing be performed to ensure that the Plan is working and that the consumer is protected from consuming SE-contaminated eggs? At this time I'd like to reverse the order and start with Dave on the panel.
DAVID GLAUER: I think research does indicate that environmental testing is an appropriate means of surveillance or at least verification of the effectiveness of a program from the standpoint of SE. We are, here in Ohio, doing NAA testing and that allows us then to effectively react to a house that has a positive environmental and cleaning and dust infection. The producers need to review their program, if they do have a positive, to make sure that all of the best-management practices really are in place and if any of them need to be improved.
MARILYN BALMER: Meryl.
MERYL SOSA: We believe at FACT that the cornerstone of an SE Risk Reduction Program is mandatory environmental testing. Absence of such testing, how does the producer know whether the layers are infected since the infected layers are generally asymptomatic? Unfortunately, most of the QAPs including the UEP Program and the Ohio Program, if they do include any environmental testing, require the test only two to three weeks prior to depopulation. By this time, thousands of contaminated eggs could already have been produced and marketed. The risk assessment demonstrates the need testing especially on large farms. It found that by flock size strata, the largest stratum, flock size is of 100,000 per flock, contributed almost two-thirds of SE-positive eggs. In terms of the test itself, FACT supports environmental testing over testing of batches of eggs as I discussed earlier.
And FACT will be including a copy of the Nest Eggs SE-testing protocol as part of its written comments. However, briefly, the protocol requires at a minimum, environmental tests of chick papers, the empty layer house, pullets at 10 to 15 weeks, layers at 29 to 31 weeks, layers at 44 to 46 weeks. And we feel that in flocks that are force molted, there should be an additional test at 5 to 7 weeks following return to feed. And that a similar protocol is followed by PEQAP.
MARILYN BALMER: Tad.
TAD GROSS: The one thing, the thing that does assure, is that testing does educate us as producers to verify that we do have problems and, you know, it has become very essential that the testing be done at all stages in the Ohio Program. In the initial offset, we were missing parts of that program and now have put them into place. And as we go ahead and continue to put our program together and make it better, our producers are now becoming more educated to the fact that you got a problem. You know it. You can fix it. Without the testing you're lost in the world and things go on. So the environmental testing is a very big help for everybody in trying to do the best-management practices.
MARILYN BALMER: Within the Ohio Program, how often? I need a comparison here.
TAD GROSS: We just put the pullet monitoring in which we had not had prior to about four months ago. We're doing testing after the molting and we're doing testing prior to the birds going out. So we basically have an environmental testing in three different locations in the laying flock now.
MARILYN BALMER: Anybody at the table?
DARREN MITCHELL: Darren Mitchell, CSPI. Part of the reason I brought up the testing and diversion under Question 4 and not Question 6 is because, I guess, the term "verification" is a little too restrictive from our perspective. We see the testing program serving both the verification function to inform producers and the regulators when there is a problem so appropriate corrective actions can be taken. But also that's part of the egg-diversion component that's to be used if a "kill step" is not being used at the processing plant. And I think it may behoove the group and the national standards work group as well to tease out those two aspects. There's a verification component and there's a testing and diversion component. The same tests could be used for both purposes but let's tease that out and let's separate them. Have different categories so it's less confusing -- maybe I'm totally misinformed -- but, so that it's less confusing if people are trying to understand the program.
I noticed in looking over the components that under 4 there is a verification validation category, but none of the letters or numbers after it say egg testing and diversion and talk about diversion. So we'd like to see that change made to both the components and to the overall Action Plan.
MARILYN BALMER: Anybody else from the table? Okay. Open to the floor.
RITCHIE LAYMON: Yes. I'd just like to respond. I heard the term best-management practices used seven times and I can't see any justification for forced molting being called a best-management practice. And with regard to Ms. Walters' statement that this shouldn't be turned into a forum for animal rights activists, I agree with her. It shouldn't be turned into a forum for AR. But, I think people should know here that the animal rights activists are very often advocates for the consumers. It was animal rights activists that were the first people to alert the State of Ohio to the best-management practices of the Buckeye Egg Farm, which is the largest egg producer in the state, and they are now being pursued by the attorney general. So I wouldn't dismiss us as not caring about consumers, just having our own agenda, we do care about consumers. We are consumers.
MARILYN BALMER: I believe there was another hand.
LOU CARSON: You need to identify the speakers.
MARILYN BALMER: Could you repeat your name?
RITCHIE LAYMON: Yes. Ritchie Laymon. I'm speaking on behalf of the United Poultry Concerns.
MARILYN BALMER: Okay. If you could go to the mike.
KEN KLIPPEN: My name is Ken Klippen with United Egg Producers. And I was much encouraged, Rebecca, to see that the testing, the environmental egg testing, would lead to egg testing and then with positives would lead to diversion of that product. And that's something that the egg industry is supportive of. We're not against testing. But we're against extensive testing when we find there's a negative environmental test. Why continue testing when it's negative? So, the product that is actually going to the consumer is the egg, not the environment, so if the egg is positive, by all means, those eggs should be diverted to pasteurization. We are much encouraged to see that clearly defined. We are supportive of environmental testing, supportive of when the environment proves positive to testing the eggs and then diverting that product.
MARILYN BALMER: Any other comments, any comments on the number of times? Meryl.
MERYL SOSA: I would just like to pose to Mr. Klippen the question that the United Egg Producers Program currently -- and this is the program that I would assume that you are proposing in their comments -- only requires testing two to three weeks prior to depopulation. So given the fact that it takes several days to get the results back, how many eggs would then, if there was an environmental test, and it proved positive, then how many eggs would really be then tested. And really how effective is that going to be if you're only testing the eggs at the very end of the cycle and you're not testing throughout the cycle?
That's why we really feel, and we've been doing on our farms, tests throughout the layer cycle so that we really have a good understanding of whether we have SE on the farm and we can really do something about it.
KEN KLIPPEN: I think this is the --
MARILYN BALMER: Ken, can we just note for the record that it's Ken Klippen?
KEN KLIPPEN: With United Egg Producers, thank you. I think this is the kind of conversation that we like to continue, because we have seen some dramatic changes both in the industry and also some of the comments we heard this morning. People were trying to come together on the kind of testing. Now, the point that we're making is: Why is it necessary to continue testing when you already have established that you do not have it on the farm? If you test prior to depopulation and it's negative, well, then you know that you have not got a problem. Why continue any kind of testing? So when you replace that flock you do not have a problem on that farm.
If you do have a problem, well, then you go into a much more extensive testing program where you ratchet it up so to speak. You do a cleaning and inspection. You test extensively at that point. You test later on in the production cycle, 30 weeks of age, ect. But the point is: If you haven't -- If it's not on the farm, why go to the extent that's being proposed? And that's what we're saying. There's testing of the chick papers, so you have the initial tests and it's testing at depopulation. And that is what we're trying to accomplish. And I think that's significant and you're seeing some changes in the egg industry coming over to accepting increased amounts of testings.
MARILYN BALMER: Dave.
DAVE GLAUER: Dave Glauer, Ohio. Again, I think as we look at programs and as programs do change, there are critical areas of intervention that we can include in these programs. And I believe that the placement of SE-monitored free chicks, then with a pullet testing program, that we know what is going on with that pullet, and if they're placed, I agree with Ken, why continue testing? But if we do have a positive then this allows the producer again to make the decisions as to what they are going to do with that flock. And so the programs do allow for that. And if a flock is tested throughout its life, then the coming back with egg testing also makes sense to me from an economic standpoint. That way we have the ability to look at what really is going on in that flock and whether it is a critical food safety issue.
MARILYN BALMER: Meryl Sosa.
MERYL SOSA: I'd like to respond to the issue of why would you want to test if the test prior to depopulation shows no SE. And the response that I would have is: Based on the research and studies that have been done, it doesn't take a lot for SE to get into the house. It can be in the feed. It can be in the dust. It can come in on rodents which it's extremely easy for it to come in on. And once it comes in on the rodents, studies have shown that rodents go directly to the feed. They leave pellets. And that's the first thing in the morning that the hens eat. So without getting too graphic, I just feel that SE can be introduced into the house at any time. And so it's not enough to just do it at the beginning and at the end. But I did want to make one comment which is I had not noticed in the UEP Program prior to this that they do believe in testing chick papers. So I really appreciate the fact that they want to add that to their program.
JILL SNOWDON: A general comment that I'm --
MARILYN BALMER: Name.
JILL SNOWDON: Jill Snowdon, thank you, Marilyn. Jill Snowdon at the Egg Nutrition Center. I'm hoping that there's going to be enough flexibility in whatever is used as verification that as research reveals new mechanism to verify that a program is working, or that eggs are free of contamination that we can roll those in. Because, what is currently could be considered to be the best means of verifying that a program is working or that an egg is free of contamination, could change as research results come in. So it's a comment suggesting that enough flexibility to allow the Egg Safety Plan to change to reflect advances in research and technology. It's a less than perfect system that we currently have to predict the probability of a contaminated egg. So that's certainly an area that we could improve upon.
MARILYN BALMER: Phil.
PHIL DEBOK: Phil Debok for the Pennsylvania Department of Agriculture. I think one of the key statements that Ken made in his comment would be the follow-up action on a flock that was shown to be environmentally positive at the increased oversight and the increased testing, that this approach would likely meet the objectives of the reduction by up to 50 percent by the year 2005 and perhaps win the nation eradication by 2010. But the other important thing is it also may be the only affordable way to go. The amount of testing that's perhaps proposed that's on the same level as Pennsylvania Egg Quality Assurance or whatever spread across the country even though the flocks of Pennsylvania may be barely affordable. This is somewhat of a compromise but still may meet the goal that we're after.
KEN KLIPPEN: Ken Klippen, United Egg Producers. I think I'll move my chair right here so I don't have to say it. I just wanted to make one more clarification and that is the testing that we are proposing, the egg testing, is not just a one-shot type of testing. This is over an extensive period of time. If we find positives and we go to egg testing, we would test over a four-week period because we recognize the intermittent shedding of SE. And the second thing is that if we have a positive house, environmental sample positive, the recommendation from United Egg Producers is that they vaccinate. And some of the recent research we have seen has suggested that that would contribute to furthering the efforts of reducing the sheds. So that's another step, that the egg industry has come over to doing what it can to try to play it's share at reducing the incidence of salmonella.
MARILYN BALMER: Ken, could you clarify that? You're saying you recommend vaccination when? If you find a flock positive, the next flock, that flock?
KEN KLIPPEN: Correct.
MARILYN BALMER: No, I'm asking when are you saying it? Please clarify.
KEN KLIPPEN: Well, if you have a positive flock, positive house, thank you -- I'm turning to my expert here --if you have a positive house, well, then you would start your egg testing. And if you have positive eggs, you would start to divert those eggs. You would vaccinate -- the next set of pullets that would come into the house would be vaccinated. Did that answer the question?
MARILYN BALMER: Yes. Thank you. I just wanted clarification. Bob.
BOB ECKROADE: Bob Eckroade from the University of Pennsylvania. I'd like to support what Phil Debok said here about these programs. Certainly in Pennsylvania we went the hard route of all this testing and felt that it was necessary to get a handle on the problem. If we use Pennsylvania as a model, and that may not be absolutely correct, we could predict that the number of positive houses are probably going to be down in the 15 percent range, not in the 50 or 60 or 70 percent range. And I think perhaps our program should be designed to at least identify and then focus in a very significant way on those positive houses. And that's not to say that a previously negative house may not go positive. But I think we need to stand back. And this is an extraordinary new program; that is, to think we are going to go on every layer house in this country and start doing microbiological assessment.
Now, we support the idea that that needs to be done at some level. I think the question is can we jump in with a new program and do all this testing when we could almost predict that only a very small number of those, relatively small, is going to be positive. So my own position, having worked in Pennsylvania with all the testing that we do and still do for a national program would be to start a little smaller. And it won't be perfect. And we will miss some of those flocks, as was said up here by Meryl, that have been shedding infected eggs for some period of time if you only test at the end of lay.
But I don't think we're going to be able to do the degree of testing on every layer house in this country in order to achieve that. What I really do believe is that we start with the chick papers, NPIP monitored, and the end of lay, and then we really focus in on the positive houses. And we spend our time and our money and our efforts directing at that, and gradually, I believe that the industry itself will demand even more to control where we have positive houses, but not to impose a Pennsylvania Program uniformly on every layer house in this country.
DARREN MITCHELL: Darren Mitchell, CSPI. I would urge UEP and others who are talking about the prohibitive costs of the kinds of testing that people like Ms. Sosa are talking about. I would urge them in their comments to elaborate on what those costs would be and then let's compare that to the costs to consumers of the SE problem. Instead of throwing around statements that things are too cost prohibitive, let's actually look at some of those numbers, let's compare them to the CDC numbers and the cost of foodborne illness and figure out what the cost of consumers would be if a program like the one proposed in the Action Plan is not adopted.
MARILYN BALMER: Terry.
TERRY TROXELL: Terry Troxell, FDA. Bob, if you're approach would be to identify the positive flocks, then would you be recommending that all flocks be tested initially at the start of the program so that one could identify and focus in on those flocks?
BOB ECKROADE: That would make sense to me that you do a national testing and then focus in on the ones where you have any positive samples. Yes.
MARILYN BALMER: With that, could you clarify? Would you start at any age or at the beginning at the placement of a new flock?
BOB ECKROADE: Well, I would start at the end because the opportunity for the contamination to build up in the manure even though we know they can go negative having been positive would be the more likely one than to test an empty, just cleaned, layer house. I don't believe that the testing after cleaning is absolutely going to correct the problem either. That is clean, then test and then not allow chickens to go back in there. That in itself we've seen is not an indicator of whether that flock will end up being positive at their end of lay.
MARILYN BALMER: There was somebody from the floor that had their hand up. Can you go to the mike, please?
TOM HERTZFELD: Tom Hertzfeld, Hertzfeld Poultry Farms. I also am a member of Ohio Poultry Association and UEP and in regards to the testing of the eggs in Ohio here, which is quite similar to UEP, if a layer facility environment sample is positive, sample 480 eggs no later than two weeks from the initial sample; then in intervals of every two weeks for a total of four samples. If egg testing results are positive of SE, eggs from that house will be immediately diverted to a breaker and in Ohio we will submit four 1,000-egg samples collected at two-week intervals. If the four samples are negative, the production following the last negative sample may enter the whole-shell egg market.
In response to some of the cost associated with it for the Quality Assurance Program in Ohio, our biosecurity paperwork and documentation, our research, indicates that the cost for an Egg Quality Assurance Program is $60,000 per year per million chickens which does not include economic losses or the possible devaluation for diverted eggs. And then U.S. grading costs another $100,000 per million birds. And then there's also upgraded refrigeration that we're looking at. Our test kit costs, and then the costs are out there. And we did poll the producers in Ohio, and that's where these figures came up from. Thank you.
MARILYN BALMER: And you will be submitting them?
TOM HERTZFELD: Correct.
MARILYN BALMER: Thank you. Another one from the floor and then we'll come back to Meryl.
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. To follow-up on cost estimates, the industry is starting to develop so I just wanted to share an example with you. I think the point that was made is very valid that we need to look at specifics on what things are costing and to flush that out. We're estimating somewhere for testing costs alone, and I believe it was only twice during the life of a flock -- Is that right? -- I think we're somewhere near $20 million. So that just starts to give you some perspective on it. That would need to be flushed out more completely depending on what the testing program is how detailed the analytical process would be, number of tests and so on and so forth, but you're definitely talking about millions of dollars, and that's just testing.
MARILYN BALMER: Meryl, you had your hand up?
MERYL SOSA: Well, first of all, we did bring our figures on how much it's costing us to test our flock and, as I said earlier, we have a fairly extensive flock testing program. So, basically, what we've found was that it cost us about $2500 per flock, and our flocks are about 5,000 hens. So that would be a cost for a very extensive program. And in addition to that cost, we also vaccinate and that costs us about $675 per flock. And then we clean out each flock house. That cost $250 per house. And we're performing water monitoring tests at about $36 per flock. Finally, we pelletize our feed at about $8 per ton. And I think the total cost came up to be something like $3900.40 higher package of the plan. Basically, it cost $16.50 per laboratory sample. So that kind of gives you an idea.
But we also want to mention at this point that we do feel that there should be some kind of insurance mechanisms or indemnification programs that should be out there. Another one we agree with UEP on is that their proposal that there should be indemnification to the producer at the dollar value of differences from the shell-end market value and breaking-stock egg value when eggs have to be diverted.
So I think that some of these mechanisms can help producers and will encourage compliance by producers by putting these mechanisms in place. And they have been used in other areas, in other food/animal areas.
MARILYN BALMER: Tad.
TAD GROSS: Tad Gross. The comment that I'd like to make is: As we developed our Ohio program, and Dr. Glauer you can correct me if I'm wrong, one of the issues that come up in regards to testing was there was a lot more testing required and asked for. But it got to the point with our lab here in the state that we could bury them in testing work and not get the results that we needed. So I think some of this has been sorted down to try to get to a point where it's effective but also can be worked through our state laboratory here. In the state was where one of the problems was that we faced by having so much testing. So that's the reason we put together what we have.
RICH DUTTON: I'm Rich Dutton from Michael Foods Egg Products Company. I'm going to read in part and I'll send this in later. Actually, Michael Foods Egg Products Company accounts for about 12 million hens and about one and a half million contracts and then, plus, contract processing also. We've been in a testing program since 1991. In '92 we had a trace back and that focused quite acutely at some problems. And in actuality, those houses had been tested previously and I'll refer to them later.
Our program was basically developed and we have become very aggressive as a self-administered program and we also do our own testing. Our many experiences have given us a wealth of information on relative value of various SE-intervention strategies. Over the past three years, well, if we just average up tests in the last three years, we do about 5,000 cultures a year, about 2,300 of those are environmental, about 500 chick-box samples and about 350 meat and bone samples to give you an idea. What I have is several comments, and if there are questions later, I can answer those.
Number one is that we confirm that pullet testing is an important tool for protecting the total farm environment. Our pullet farms in Nebraska are washed, disinfected between broods, and the farm or sister buildings are depopulated at the same time. In other words, we take the farm, hopefully, and depopulate the whole farm. In most cases, the farm is without birds for a short time, hopefully. In the real world it doesn't always happen. These houses, for your information, are cement-floored, flat-floored built houses, primarily.
Growths are very few in most cases. We do and have been checking and culturing chick papers for some time. In actuality, infrequently, but it does happen that we do have a positive in a house. In fact, in one of our circumstances we had, of ten houses, we had one positive house which was in the center of the complex. Sister birds that were placed three days afterwards, the same breed, same strain, same hatchery, and so forth, never did become positive.
Going on to another point, we actually have been testing chick papers for a long time. In the last three years we've checked about 1,500 chick papers, we've had no SE positives. In nine years we've had one SE positive, and that was early on in the program and we've not had any since. But, of course, my comments are relative to our situation. We find rodents are a major source of SE exchange. The cost of doing a program would be somewhere between $15,000 and $30,000 for a million -- actually, those are figures from a 4-million-bird complex.
Vaccination is the single most effective step in slowing the contamination of SE in a complex. The vaccination of one house in the complex does not seem to be as effective as vaccinating all houses. In our complexes we have between 18 and 24 houses predominantly, and one complex of 32 houses. The vaccination cost for a kill-vaccine program is between nine and ten cents, generally speaking; for a live-vaccine program, somewhere in the one and a half to two cents; for a combination maybe ten to eleven cents; and in severe cases where you do a double vaccination, a kill vaccination, that would be somewhere between 18 and 20 cents per bird.
Based on effectiveness for dollars spent, the priority of activities within a Flock Quality Assurance Program should include an effective rodent control program, a vaccination and sanitation in that order of importance. The live vaccine has not had the longevity of use to prove itself in practice although the cost appear to be attractive and the yearly results look to be good.
And going on to another point, in the last three years, we tested probably 1,000 samples of meat and bone. And in our situation, we've had no SE, although, the salmonella varies from zero in some cases from some companies to 80 percent.
I guess one point I would like to make is that there is no predictability of when and where you will have salmonella or SE. Just because we've had a program in existence does not mean that that house will remain negative. On the other hand, we have had SE-positive houses that we've converted to negative. We've had complexes that we've converted to negative. We've got complexes with -- the 3.2 million complex has been negative, and never has had an SE isolation.
Our success has come with persistence, tenacity, and aggressiveness. Rodents are the key difference between a negative and a positive program. Actually when we began in 1991, we tested all houses. We had probably, predominantly, at that time, most of the contract houses, so we tested approximately 100 houses. We had four houses that were positive out of 100.
MARILYN BALMER: Rich, could you quickly summarize because we still have the last question to bring up.
RICH DUTTON: Sure. Egg cultures will cost between $500 and $1000 for a thousand egg sample. And sanitation costs between $1000 and $5000 to sanitize a house. And actually, we've had a circumstance where we did a complete sanitation and replaced with negative birds and did a rodent program and so forth and came back with a positive house within 12 weeks. And then going into that, those eggs were diverted then for the life of the flock. The next flock was vaccinated and we were then able to, for the next four years, we had no isolations of SE. I guess in comment to the environmental testing, our predominant testing program was testing chick papers at 14 weeks for the pullets at peak production, at peak-molt production and end of lay and that gave us the opportunity to control our situation basically.
MARILYN BALMER: The third question is: In the event that an environmental sample for SE is positive, what, if any, additional steps should a producer be required to take with a positive flock house and with the next flock that will be placed in that house? If we can start, we will start with Meryl.
MERYL SOSA: I'm going to keep my comments brief since I've already addressed this issue. The additional steps that should be required with a positive flock should be that there should be diversion of eggs. Our program requires that we take some other measures, you know, increase our biosecurity, you know, review our plan and then test again to see if we still have SE and if we do, then we would continue to divert the eggs. Prior to placing the next flock, of course, we would clean and disinfect the house and test after we've cleaned and disinfected because research and studies have shown that even after you've cleaned and disinfected, sometimes SE persists in the house and you need to clean and disinfect again. So, you have to clean and disinfect until you've made sure it is SE negative.
MARILYN BALMER: Tad.
TAD GROSS: I think most of it's been covered here again. You go into environmental samples, you're going to sample 480 eggs which Tommy Hertzfeld alerted to. The biggest thing is the continued follow through of cleaning and disinfecting after the birds are taken out and following up to make sure it's kept clean. But I think what we've covered most of what we need to do here in this particular question.
MARILYN BALMER: Dave.
DAVID GLAUER: A couple of comments, and they would kind of be encompassing of what we've tried to approach here, I think, in this first segment. And I think we've had some figures given on the economic aspect of the program. Also we need to look at that.
We need to include, then, laboratory capabilities. We need to focus our testing on those very critical kinds of areas that can create a control in the programs that allow us to do the environmental testing. If it's during a lay, then we have the ability to continue testing those eggs, divert those eggs, or whatever the appropriate step may be.
The other aspect that we need to think about is we put together the critical parts of a national standard program that allows the use of vaccine. Vaccine is not the entire program, but it certainly can be used as a very useful tool.
The best-management practices also are critical to that. The things again that we had listed on the screen earlier from those individual standpoints, I believe, are the individual components with the addition as we look at environmental testing, pullets become part of that.
Chick papers, my Pennsylvania colleagues and I have had many conversations about that. I believe that NAA pullet testing, the environmental, can be looked at from a scientific standpoint as being a critical test.
MARILYN BALMER: Okay. Those at the table here. Any comments? Okay. Then we'll start with Tom.
TOM HERTZFELD: Tom Hertzfeld, Hertzfeld Poultry. I'd just like to add that on a house that is a positive, for us to C & D it here in Ohio, depending on the size of the house, it is approximately anywhere from $4,000 to $8,000 to wet clean that house. The concern that people like myself and Tad have is our contract growers that we've got, this is a substantial cost for a smaller contract and unless we step in and help them out with the cost of C & D it's extremely hard for them to cover that cost so we would ask that you would consider an indemnity for a situation like that.
MARILYN BALMER: Tom, you gave a range. Is it style of house or number of birds per house?
TOM HERTZFELD: It's basically the number of birds and the style has a little bit to do with it, but depending on the size, the $4,000 range would be right at a 100,000 bird house -- probably 70,000 to 100,000 bird house and then it would go up from there.
MARILYN BALMER: There was another one. Ken.
KEN KLIPPEN: Ken Klippen, United Egg Producers. Just a quick comment about environmental testing and then diversion as Meryl brought up. The concerns we have about environmental testing and then the likelihood of a diversion, which has already been brought out by the panel, are the rodents that we are trying to control in a farm environment. One rodent can deposit 100 pellets in the course of one night and each pellet can contain 25,000 different salmonella organisms. So you can see how one rodent can really cause extensive damage to a farm facility if you are looking at that kind of environmental testing. Biosecurity is all part of the program, but the diversion doesn't enter into it until you have sampled the eggs. That's extensive and we're still working on the size of the sample. But, sample the eggs and then when you find those positives, then you divert.
RICH DUTTON: Rich Dutton, Michael Foods. Just on a cost basis, we have a flat floors, stack decks, belted houses; to wash a house takes at least two weeks, eight to ten people, and nearly 24 hours a day washing per day to get it clean. In one case we had a farm that we washed up, and it took two or three disinfectings and two or three foggings to get it to a point where it would be culture negative. The only thing in all of our changes and problems with houses and so forth, the only things that we've been able to use has been vaccination and elimination of rodents and clean up consistently.
As to other sources, chicks have not been a problem. Feed is not a problem. We've not had an isolation from feed. And water is automatically tested because of the required AMS Programs and so forth.
MARILYN BALMER: Mike.
MIKE OPITZ: Mike Opitz, University of Maine. With regard to what should happen if a test house is positive, I would like to present this philosophy which we have. We use testing in our area to verify the management practices which we have implemented on the farms.
We believe that sustainable long-term egg safety is achieved through the management practices which are implemented on the farms. Most of them have been mentioned here. Therefore, as a consequence of a positive test result, our main emphasis will be on viewing the management strategies and correcting management problems that can be refined and improved and, therefore, test positive results will be a tool to identify those needed improvements which we may not even completely understand at this point as we are sitting here. But we have to keep in mind long-term sustainable, error-management practices and not look for short-term bandage solutions.
MARILYN BALMER: If that is it for comments, we'll take a break and start back again at 10:25.
(A break was taken 10:12 to 10:30)
MARILYN BALMER: Alice Thaler will begin.
ALICE THALER: The information that I'm going to cover now is information that's directly from the Federal Register Notice for this meeting and also in the document that's in your packet which is posted on the web which is the outline of the information that the Egg Safety National Standards work group has put together as a draft.
The question is: What steps will help us reach our Risk Reduction Goals. And it clearly says in the notice that we're considering several mandatory components as part of our Risk Reduction Plan. The thinking so far is that industry would establish a HACCP-based system for shell-egg processing and prerequisite programs to help reduce the risk.
What would it take to implement the proposed components of a HACCP-based system? Of course, this morning we had some information provided as to cost for the producer section and we're interested in costs here as well. And what are adequate good manufacturing practices? We need to define those and as a basic requirement they have to minimize the growth of SE and prevent cross-contamination during shell-egg processing. We're here to discuss record keeping; what should be the requirements, things such as receipt and inventory usage records that would include returned eggs which perhaps now aren't tracked as well as they should be. Producer identification, how important will that be to this effort? Data production by lot. Records on temperature on transport. That might help our effort. And monitoring storage temperatures. Controls and receiving would be part of the components.
For example, methods that a packer or processor could use to determine how old eggs are when they are received. Certainly some eggs go very quickly if you are a producer/packer. Some eggs go directly to packers, but there are many that seem like they skirt all around the country before they get there. How important would getting a handle on that be to our risk reduction effort? Other controls at receiving, especially now that we may be identifying and diverting more positive eggs. That's certainly one of the issues. What will be the measures to ensure that those eggs are diverted from the table-egg market, and measures to make sure that they go and are pasteurized.
This was, for example, an issue. If the status of a flock is not revealed to the packer then they don't have the information on how to deal with those SE-positive eggs. Where if they knew the status, they could have something in their plan to address handling those eggs and making sure that they go to pasteurization. Packers might require information about how the eggs were produced. Give them a little bit more to go on in making their decisions on how to handle the eggs at packing to know if the producer did use the components that we heard earlier on-farm plan.
What about the materials that the eggs come in on? How important is it to control the sanitation of those materials? Should we go so far as to allow reusable materials? Should they all be new? All that is at issue. Under Strategy I, the movement of SE-positive eggs needs to be controlled. So, again, we're talking about how do you store them if you're the packer and they come through your facility because your a producer/packer?
Refrigeration from the time of gathering to processing, will that be important to the Risk Reduction effort? And if so, what would be the temperature be that would be appropriate is up for discussion. At the packing plant, refrigeration might play a role. So what would be the cost of maintaining refrigeration, for example, let's say 60 degrees fahrenheit, for eggs for grading and packing before they're packed. They can't get too cold because of the process they go through for washing and packing as a shell egg. But in particular, if they're going to be held for a period of time that would exceed 24 hours from the time to lay. The prerequisite programs that FSIS typically use when we're talking about HACCP or HACCP-based systems would include sanitation, standard operating procedures, the basics of these require processors to address basic sanitation of premises and facilities. And then the plan specifically describes the food handling practices, the cleaning of the equipment and the maintenance of the facility itself. Other prerequisite programs would include the rodent/pest control, which we just heard, is seen as a very important thing and on the production side, it is also important on the packing side, especially if you're a producer/packer. Programs to ensure employee health and hygiene of people handling the eggs, portable water issues. Prerequisite programs for controlling the compounds that go into the overall process. Things used to clean, to stain, sanitize we have used in, for example, meat and poultry plants. Letters and guarantees from manufactures is acceptable if they state that the product is acceptable for the intended use. Also prerequisite programs can cover things such as guidelines in general and education of people during the process.
We move then from prerequisite programs to process control, I didn't put HACCP here because we were talking about HACCP-based at this point with the shell-egg packers. But that is essentially process control. Issues such as washing the eggs. How detailed should we get in the specifics of what's required for process control programs? We have some information already in the shell-egg grading program they address some of those issues and whether or not what's already available could be used, modified, or adopted to deal with HACCP-based programs more broadly for all shell-egg processors. They get down to specifics such as pH. Should you recommend a specific level? Should you just make a general statement that has it has to control microbial hazards? So we're looking for that level of detail as well. The shell-egg packers do grading of their own as well as some of them -- 30 percent being under the USDA grading program. We have an issue of the tolerances allowed for the checks and undergrades because of the possible relationship they might have to increased SE risk. So it's possible that the tolerance might need to be changed either now or in the future if that connection is considered to be important to address, if it exists than it is important to address.
And the probably really big one, although it's only a short line, eliminate reprocessing and returned eggs for table use, I would imagine, will be a big issue to discuss. Packaging materials for what goes out to the consumer, again the question of should it be limited to new materials, storage and handling practices for the packaging materials themselves.
And then I put down customer specifications as they relate to the processing of SE-positive eggs for egg products. We heard some earlier requests for indemnity. The general question of if the customers who are going to get the eggs are very concerned about the SE eggs and where they go, and more eggs are going through the packer/processor that need to be diverted to egg products depending on how the eggs flow, what would be the influence overall to the packer? And packing shell eggs for the consumer to prevent cross-contamination.
Again, process control, there is to consider using new packaging materials. But then the question of what would it take to be able to reuse and have clean reused materials? Another general broad issue for this area's labeling, having records that explain what codes they used, whether or not records should correlate with the producer and with the company processing records; such as, the actual lot and whether that should be by case, by carton, how that should be broken down; and just realizing that there will be some FSIS and FDA labeling requirements that would be part of what will affect the shell-egg packer.
Control at storage and transportation, address the issue of what's best to monitor the temperature of the refrigerated storage units. Is that important and should it be an ambient temperature? All of this is still open for discussion.
Now we'll go through this one quickly and I was asked to mention, of course, there's another section farther on that will focus on research and have the broader question But, specifically, for the packer/processor, keep in the back of your mind, what kind of information don't we have in order to be able to make statements about some of the earlier issues that were posed? So just to recap the general areas of issues, we had the prerequisite programs, we have labeling, we have Risk Reduction Strategies in general, controls at receiving, process control, and storage and transportation and then, of course, research to help answer some of that. So we'll move to the questions now. I'll take the first questions now.
MARILYN BALMER: I want to remind everybody there is at the end of this day an open session where you can give talks in general. Let's try to keep the comments to the specific questions in this area, the first one being: What is the cost of maintaining refrigerated storage, maximum temperature, 60 degrees fahrenheit for eggs received that are destined for grading and packing or in-shell pasteurization when time of processing will exceed 24 hours from the time of lay? Let's start with Tad first.
TAD GROSS: Tad Gross with Hemmelgarn. As we're all aware, we now have refrigeration requirements that we, as processors, are required to live by which is 45 degrees. In our company's case, we were in compliance with all that. We stepped up and put additional refrigeration in to make sure we can maintain that in the heat of the summer. I guess you start looking at a cost get towards 80, 90, $100,000 to make sure that you've got all your cooling capacity in place.
We, at our company, have taken extra steps to make sure that we can do these things. And in our Quality Assurance Program, we feel that some of the issues throughout the country have been lax as far as the temperature thing. There were still people, quite frankly, a few years ago that didn't even have refrigeration at all. So as egg processors, we are starting to get the attention that, yes, we've got to get in focus here and get going. But in answer to the cost thing, I think we feel it's going to cost about $100,000 to make sure that you've got refrigeration in place.
MARILYN BALMER: Meryl.
MERYL SOSA: We don't have any comment.
MARILYN BALMER: Dave.
DAVID GLAUER: I really believe that Tad covered what I would say. But, again, just in review of the industry, it does look like in Ohio that somewhere around $100,000 is required on a million birds from a refrigeration standpoint. We do have a refrigeration law. Here in Ohio our Food Safety Division from the Department of Agriculture is responsible for maintaining that. They inspect that on a regular basis. So that does provide some additional incentive and makes sure that that part of the program is followed.
MARILYN BALMER: One question to the three, does there make any difference between offline and online for refrigeration costs? Any comments on this?
TAD GROSS: This is Tad Gross. I guess my answer to that would be, naturally, on an inline coming directly into the processing facility they'd have one facility that they'd have to keep under refrigeration. In our case, with the contract producers in my particular case having 18 or 20 different family farm operations, each one the facilities have to have refrigeration at the farm. And then the next step is the transportation to the processing facilities. That equipment has to be able to maintain the 45 degree temperatures that our Egg Quality Assurance program alludes to as well as in the plant. So in my particular case, we have three sets of refrigeration in order to comply with the 45 degree temperatures.
MARILYN BALMER: Okay. Anybody at the table?
VICTORIA LEVINE: Vicky Levine, FSIS. So you're saying that for each of those three facilities, it cost $100,000 for the equipment? So 300 total?
TAD GROSS: Probably at the farm -- I'm talking from on the farm to the transportation and you're going to have $100,000 because we have three steps in there.
MARILYN BALMER: Any other comments from the table? Okay. Out on the floor? Presently are many people staying at 45 -- or there's a comment here about maximum temperature of 60 degrees?
TAD GROSS: Tad Gross. Our plant runs two shifts. We're totally under USDA supervision. Now when the USDA people come in to do surveillance, they monitor our air quality, the temperatures in all of our coolers, to make sure that we are around or close or below that 45 degree temperature. So being a voluntary program, which USDA is, it puts us, you know, keeps our act together as far as keeping it. But it also assures to our consumers that have the USDA product seal on their cartons that we're maintaining all the things that we say that we're doing.
DARREN MITCHELL: Darren Mitchell, CSPI. We'd like to see this at 45, actually we've called for 41 degrees, but we'd like to see this at 45 degrees for the whole process. And, if during rulemaking that 60 degree maximum shows up, we would like to see some substantiation justification for the 60 degree fahrenheit number versus the 45 degree number.
TAD GROSS: Tad Gross. I think one thing that you have to remember here, there's two basic situations in egg processing. You have inline which comes right out of the chicken house into the egg grader versus offline, which my particular situation is different. The problem you've got with your request is, if you take 45 degree eggs and put them on an egg grader like I would have to and try to run them through that washer at 100 degrees, you create checks. And that's one of the issues that has become very sensitive between us as egg packers and USDA. Because naturally that's one of our goals, to eliminate checks. And here these temperatures are also putting us in a position where we're actually creating checks. So the ultimate goal is to reduce checks not to increase. If it comes in there and -- Quite honestly, we see our eggs going into the egg grader somewhere at 45 to 48 degrees, but if we get it down to 40 like you suggested, we can increase checks as high as 3 to 4 percent just because of the snap of the temperature change. And it's very crucial and it's very sensitive and, again, the main goal here is to reduce checks. I mean, obviously, if you've got a cracked egg, you're susceptible to bacteria. So let's try to eliminate that thing first of all.
MARILYN BALMER: Darren.
DARREN MITCHELL: Can I respond to that quickly? Darren Mitchell, CSPI. I guess the concern is that exceeding 24 hours from time to lay and whether that number makes sense, the length of time that the eggs are sitting around at the elevated temperature makes sense. And there must be some way to do this so that the egg sees a higher temperature just when necessary for purposes of going in through the washing steps, ect.
MERYL SOSA: Meryl Sosa, Food Animal Concerns Trust. I'd like to respond to two things that have just been said between Mr. Mitchell and Mr. Gross. First of all, I can completely understand the idea of preventing checks. We, too, want to do that with our eggs. But in looking at the General Accounting Offices Egg Safety Report, they discussed the issue of cooling and things like that and one of the things that we felt was really important from that report was that it noted that rapid cooling at a relatively low cost is available.
And for example, researchers at North Carolina State University have experimented with cryogenic gas to rapidly cool eggs. They found that eggs could be cooled to 38 degrees within 12 minutes using cryogenic gasses and one company has developed a prototype cooling method that is soon to be tested in production or may have already been tested. And according to that company's estimates, that process would three cents or less to the cost of a dozen eggs. So we feel that this is possible to have a 45 degree internal temperature, it would just require an additional step at the processing.
Now, one other thing I would like to take note of that Mr. Gross said. His main goal is to decrease or prevent checks. I don't know if I necessarily agree with that comment because I think our main goal in breeding is to prevent SE in shell eggs. I think what we now know is that most of the SE problems occur on the farm. That's where it gets into the eggs. And the idea that the SE is coming in through the checks is a possibility. But the primary location of where SE is getting into the eggs is on the farm. So we do want to focus on that issue. And the idea of preventing checks from a grading standpoint is important, but only one-third of the nations eggs are graded by USDA. So what we really want to focus on is all eggs and making sure that all eggs are safer for consumers.
MARILYN BALMER: Terry.
TERRY TROXELL: Terry Troxell, FDA. Since there is a natural protection resistance to outgrowth of bacteria in the newly laid egg and it depends on time and temperature, Tad, can you or some other people comment on the length of time eggs might be stored prior to processing? You know, the range of times?
TAD GROSS: Well, I guess that could vary from company to company. In our particular case I would think that eggs are in our plant less than 36 hours. They come in and process and then are shipped to market. It would be my opinion, again, I'm speaking for my situation as contract producers who, you know, have family operations gathering these eggs at the farm. And in most cases in today's society with the size of the houses, eggs are most generally picked up every day. In our case almost every day or every other day. But, I don't really feel that with the way the chicken houses are designed today and set up that most eggs lay in the chicken house less than probably 12 or 15 hours before they go in the refrigeration. And that should not be a basic problem from that end. A comment to Meryl's suggestion here of refrigeration and quick chill and whatever, my only comment to that, as a producer, is how and when and where and why. How can you justify that expense to do all these things when you already basically got it down there to 45 degrees? I mean there has to be some give and take here I would think.
MERYL SOSA: I understand the idea of give and take but I think this overall process that we're embarking on, we have to recognize that the cost of eggs is going to increase and the cost of eggs to consumers is going to increase. And Nest Eggs charges more to our consumers because we do have an SE Program and because also because we provide eggs from uncaged hens. So we do both those parts. But I think that all producers are going to end up incurring these same costs. So everybody is going to be charging a little bit more and consumers are going to have to accept that. I mean, eggs are much lower cost than meat or chicken or any other source of protein. So I think that's really important to keep in mind that while we have low cost now, those costs are going to increase due to this new program. And so we want to make this program the best it can be coming out of the box with some flexibility for whatever research shows. I don't know the cost for rapid cooling other than the three cent or less cost of a dozen eggs. I know that Andy Rhorer from NPIP did a talk at a seminar I was at and he had studied this issue. So he may be of some help in providing some figures and costs on this issue.
MARILYN BALMER: There was a hand from the floor.
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. I just need to reinforce the biology of the situation and how that affects the cost of food and relative to the safety of the food. And that is that the data that we have indicate that SE -- Let me back up. Refrigeration is only going to control the growth of the organism. It's not going to control if the organism is present or not. So we are talking about a very low incidence to begin with. So if SE happens to be in there, the egg has a enough natural protective properties and as long as that egg is below 68 degrees fahrenheit and that yolk membrane stays intact, that SE is not going to grow.
So what the question is here is talking about from the time that the egg is laid to the time that you are starting to move it into processing. So the question as written, I think, is written with the appropriate science in mind; that is, you're giving protection make sure that that yolk membrane isn't deteriorating and the organism has a chance to multiply. Anything other than that type of thing is going to increase the cost of food with no commensurate benefit. And I think that's frivolous because you want policies then that are going to change the disease impact and not simply increase the cost of food.
So I would say the food cost increases need to be tied into things that are going to have a benefit that society is going to value, like, say, for food. So we need to target what the actions are to the ones that are going to be reflective of the microbiology of the situation.
MARILYN BALMER: Any other comments from the table or the floor?
KENNETH ANDERSON: Kenneth Anderson, North Carolina State University. Be careful what you say because the individual doing the work may be present. But first of all, a couple of comments. North Carolina has been on a 45 degree cooling program since the early '90s. Prior to that we did an egg temperature survey in the state basically outlining the fact that at that time producers could not meet that standard.
The producers and packers at that time went in, modified their coolers, and the cost in North Carolina were a little bit higher. Some of our processors spent up to $250,000 to modify their cooling systems in order to meet the 45 degree ambient standards and to be able to maintain those temperatures throughout the processing day. Because as soon as the doors are opened at 6:00 AM in the morning, when they start running eggs, temperature fluctuations increase dramatically.
The second comment is on the amount of time that the eggs can be stored at 60 degrees. It is fairly extensive. If you look at the work that's been done in Europe by Humphries in the early 1990s, 1990-1993 specifically, it basically says that the natural protection chemical, as well as physical protection that the egg holds for itself, does extend over more than seven days so that there is a biological component that does prevent the growth of salmonella enteritidis in the egg. In addition, a lot of his work also shows that the number of organisms in the egg are almost at the nondetectible level. I mean, you're down in the 1 to 10 organisms, if they are present, which is rare in itself, are very low. So you have to look at the combination of things that the natural protective characteristics of the egg will instill to get a safe product at the processing plant prior to that.
A third comment on the egg temperatures. You really cannot start with a 45 degree temperature coming out of the production facility. Mainly, because of the requirements placed upon it by USDA grading regulations that state that the wash water shall be 90 degrees or 20 degrees warmer than the warmest egg entered into the processing plant. And like Tad mentioned, you throw a cold egg into the hot water, you're immediately going to create thermal checks. In addition, contamination rates -- contamination does occur in those thermal checks after the washing process. So you have to be careful. We're trying to prevent that. And so you want to keep an intact shell. You need to maintain that integrity of the product until the consumer gets it. And anything we do to detract from that actually defeats the purpose that we're trying to do at this particular meeting.
MARILYN BALMER: Ken, before you leave can you clarify? You were talking 45. Is that post-processing?
KENNETH ANDERSON: When I talk 45 degrees ambient, I'm basically talking post-processing. I think there's some recommendations out right now that prior to processing the eggs need to be stored at 60 degrees. However, even at that there needs to be a tempering process before the eggs are actually put into the washing system. And that's basically because when you exceed a 40 degree temperature differential between the egg and the wash water, you get thermal checks creating. And it's a gradual thing, you know, at 40 degrees it may start at 3 to 5 percent, but as soon as you hit 50 degrees temperature differential, you'll hit 15 to 20 percent of thermal check. So you need to be very careful about the temperatures. And if you look at a lot of the wash-water temperatures that are used, every processing plant that we surveyed, their wash-water temperature was not 90 degrees, it was 115 degrees which actually changes the initial temperature that you can actually start the washing process at. So, I mean, you have to be very careful.
And I think that brings into a fourth comment I might as well make while I'm standing here. We've talked about something now that we probably should have lead off with and that's HACCP. Every processor and every producer in this country has different circumstances. And if we follow the HACCP principles and seven steps and use the testing and whatnot for verification that your program is working, if your HACCP Program is working, your actual monitoring and verification is going to drop. And I think that's what a lot of people will show. Bob Eckroade, you know, pointed out that if you test and your levels are low, you don't need to continue this elevated testing because your HACCP guarantees that you are doing everything, best-management practices, everything to keep that level low.
JUDY RIGGINS: Can I ask an additional question?
MARILYN BALMER: Judy Riggins.
JUDY RIGGINS: USDA. You said that at the start when North Carolina first required the 45 degree ambient temperature, that packers couldn't reach it. Over what period of time were they able to comply? Do you have any idea of the percent compliance over the first year, over the second year? What were your milestones?
KENNETH ANDERSON: First of all, the actual passage of the law took about a year. But most of the producers in the state began the modification process immediately. Most of them saw the writing on the wall and knew that the 45 degree ambient was going to come in. So they began modification. So basically within six months after adoption of 45 degree, the processors had spent the money and were capable of maintaining 45 degrees in off-run hours. There was still a problem with the situation during the processing day.
It's very difficult when you're moving ten tons of product into a cooler and you're shipping it out to maintain that ambient temperature. So what a lot of them have done now is they're not cooling to 45. There coolers are set at 39-41 so that they can maintain that temperature compliance throughout the day. And I think by and large I feel that the producers in North Carolina have done a tremendous job of meeting these standards of 45 throughout the day. But it has taken time. And it's really difficult to put a "how many years does it take to do this or that". But, I think basically within six months, we were able to do the 45 in general; but then it took a little more refinement of their cooling process to achieve that consistent compliance throughout the day.
JUDY RIGGINS: Can you share with us any methods, techniques, that individual processors might have used in achieving their HACCP objectives? One of the things we've done with meat and poultry is developed a set of models that are used kind of as guidance for industry. And you've kind of triggered an idea in my head. If there is useful, experienced information that comes from programs that have already instituted this kind of requirement, that we could apply nationwide in guidelines, so that when a packer processor is looking at his or her own situation, can be used as guidance. Were there things that North Carolina producers did or are doing that help them to achieve that 45 degree over time throughout the day so that they know that their systems are actually effective?
KENNETH ANDERSON: Well, I think there were a number of things employed by the processors to achieve that goal of throughout-the-day compliance. But I think by and large, the models that we used -- there's three. One is the HACCP principles that were actually outlined by the Pilsbury Association when they developed their food source for NASA. The second one is the 5-Star Program from UEP. North Carolina has adopted that as the basic program for that. And then the other model is PEQAP. Let's face it. That's probably one of the premier programs in the country. And look what they've done as far as that region of the country as far as SE outbreaks.
So I think we've got models out there. And the Pennsylvania people said a lot of testing -- And there, again, if you employ the HACCP principles to the whole development of a farm-to-table program, you will actually develop a program that works well, that has adequate testing for verification that the process is working; and, then, it has procedural steps of additional testing, like Ken mentioned, that if you fall out of control, you have additional testing that automatically trips in and comes into play. I think Rich Dutton mentioned some of those as well from out at Nebraska. I think the models are there. I think what we're doing is we're using the HACCP principles in the industry to develop our programs to make them meet the needs that the consumer is -- let's face it -- the consumer is telling the egg people what they want and we're doing everything we can to comply with that. I think what we're seeing here is forced introduction of a component, something of a HACCP Program. And you don't force a HACCP Program. A HACCP Program grows and develops over time. And I think that's what we need, is the time to develop and refine it so you get an adequate program that works.
MARILYN BALMER: Ken, can we delay HACCP until the end of the day?
TERRY TROXELL: Terry Troxell. I have a follow-up for Ken. Can you comment from the North Carolina perspective on the range of times from lay until the shell egg is processed which we were discussing before? Because, that's relevant to this question of temperatures.
KEN ANDERSON: From the time in offline to processing plant, is that what you're asking?
TERRY TROXELL: The range of times from lay until processing.
KEN ANDERSON: It will vary from probably an hour to maybe two days. It depends on the pick-up schedule at the production unit. I think most of the offline production units are on daily pick-ups. But some of them may have a day where they don't pick them up. But, typically, hours in an inline -- to a day; 48 hours, maximum, for offline.
TERRY TROXELL: Thank you.
MARILYN BALMER: Are there any methods by which a packer/processor can determine how old eggs are when they are received? Let's start with Dave.
DAVID GLAUER: I'm not sure I'm the best one to answer this. I understand that there are some methods, but I'm sure someone else has a better answer.
MARILYN BALMER: Meryl.
MERYL SOSA: No comment.
MARILYN BALMER: Okay. Tad.
TAD GROSS: Well, obviously, this question goes back to the old theory of your egg quality and determining a "AA" from an "A". And in our case, if I personally don't do it, USDA will walk to the eggs and take a look and they're going to tell you by the size of the inner-cell and the interior quality of that egg, approximately how old it is. And that has been probably the industry's best indicator. If you buy eggs from the outside, that's the first thing you're going to look at is under a candling light to see how big the inner-cell is. It's going to determine whether it's two days old or whether it's four weeks old.
MARILYN BALMER: So you're saying the bottom line is the internal grading?
TAD GROSS: That's how I would approach it, yes.
MARILYN BALMER: Anybody from the table? Anybody from the floor?
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. Just a comment that eggs are a pipeline because chickens are laying them all the time. So all the market and the dynamics of the process are going to be for the eggs to be moving promptly.
MARILYN BALMER: I know we have a few people involved in egg grading out in the audience. Is there any comments as to the age of eggs? Okay. Then we'll move on. When packing shell eggs for the consumer, will the use of only new primary packing materials increase your marketing cost? If yes, what is the estimated cost? Is there a way to clean plastic containers to prevent cross-contamination so they can be reused? Let's start with Meryl.
MERYL SOSA: I did talk about this issue with our farm program manager and he responded that the packing materials that we use on our farms are not reused unless we know that those eggs are destined for the breakers. So the other area that we would like to see more research or testing done are the carts that the eggs are shipped on. And I know that those are reused throughout the industry. So that may be a source of SE. We're not sure.
MARILYN BALMER: Tad.
TAD GROSS: Well, here again we get back to the USDA situation. USDA -- again, I'm speaking for my plant -- but USDA pretty much makes us use new material for our packaging. In some cases there are people that use, maybe, something that's used one time. But in our case, all the stuff that we're packing for consumers is always in new material. We use a plastic flat for the eggs coming in from the farm. For an example, they're on plastic flats so that they can come in and they're run through a washer and sanitized so that they can be taken back to the facilities without cross-contamination. Meryl suggested here that the racks that we now use today in retail are made so they can be washed and sanitized also. But in most cases, especially in USDA plants, they're going to be packing new material.
MARILYN BALMER: When those sanitized plastic things go back to the farm, do they go back to the specific farm they came from or could they go to any farm?
TAD GROSS: In my case, no. We feel once we've run them through the flat washer and sanitized them, that they should be free of any particular bacteria and they may go in any direction. Now if we have paper flats -- which we, at this point have a few left -- those are specifically set aside to go directly back to that farm. In my case, it's two instances of two smaller houses. But they're definitely set aside and designated with names put on them as to where they go. But 95 percent of our stuff going back and forth to the farm is washed and disinfected.
MARILYN BALMER: Dave.
DAVID GLAUER: In our program we speak to the aspect of the non-reuse of soiled materials and if there is reuse that they go back to the farm of origin.
MARILYN BALMER: Anybody at the table? Terry.
TERRY TROXELL: Terry Troxell. Either Meryl or Tad, do you have cost figures for -- you say you are using new materials -- do you have any cost figures?
MERYL SOSA: I did ask the farm program manager for that information. But, he said, in our program we've always used the new materials and we've never considered using reused materials. So he didn't have any kind of figures for comparison. So we've always included that cost
as part of the price of Nest Eggs.
MARILYN BALMER: Anybody from the floor? There are other producers out there. Do you reuse? Do you use plastics and sanitizers? Any comments? Tom.
TOM HERTZFELD: Tom Hertzfeld. I'm also like Tad. All of our eggs coming in are on plastic and they are run through a flat washer continually before they go back out. So we follow the same program.
MARILYN BALMER: Rich, you're another producing area.
RICH DUTTON: We also use plastic flats on eggs coming in. Rich Dutton, excuse me. And we also sanitize everything going back out.
MARILYN BALMER: And they go back to any house?
RICH DUTTON: They go back to any house. It's pretty difficult if you've got 15 houses or more that you are doing on any one individual day to separate out. It takes a lot of storage space and tracking to keep track of those, especially if the truck may come in every other day rather than every day.
MARILYN BALMER: Are there any other producers out there that do not use plastic that still use the fiber?
There are some egg-grading representatives in your states, do you see fiber or do you see plastic? And what are the procedures? Would either of you volunteer comments?
DEANNA BALDWIN: Deanna Baldwin. I'm with the Maryland Department of Ag. We do see some of the eggs coming in nest-run and fiber-filler flats and we have seen reuse of those for graded eggs.
LOU CARSON: Tad.
TAD GROSS: Tad Gross. I see throughout the State of Ohio that there is some producers that market strictly nest-run, and sometimes they go throughout the country. But my experience and exposure to them is I see the gentlemen using only new because of the circumstance that we do. And, naturally, if a producer in the State of Ohio is sending a load to Texas or wherever, naturally, that becomes a problem to send them in plastic. So we go back to the issue then of putting them in new paper and transporting that way. But the stuff that goes back in and out of the plants usually stays close and local and usually is in plastics.
MARILYN BALMER: Any other questions on this? Judy did you have one?
JUDY RIGGINS: I was going to ask everyone in the room if there is anyone here who is not under a current AMS Grading Program and what you are doing. I'm concerned that we're hearing about the more prescriptive approach that we currently have. But if we're going to consider the option of moving to a HACCP-based performance standard approach, how many in the country, if 70 percent are not under the USDA Grading Program. What's being done in those programs is going to be important to us. I was wondering if anyone had any knowledge of that here.
MARILYN BALMER: Are there any comments on the general area of packer/shell egg processing and what Alice presented?
KEN LOOPER: I'm Ken Looper with Cal-Maine Foods, Jackson, Mississippi. We have an egg-clearing house in the United States for trading of eggs and then UEP has an egg-trading center. Today there's about a 3 to 4 percent of all eggs that are not produced and packaged on the farm that go from one farm to another farm. And they go through ECI or UEP. Now there's another 3 or 4 percent that are handled through private brokers. So this makes somewhere between 6, 7, 8 percent that are not produced and packed on the farm, that go to different places. Then there's those private arrangements where a processor may buy directly from another producer that doesn't appear on the ECI or UEP trading block or do not appear with the broker.
Our experience, and ECI has all the actual data, but all the eggs will either trade on new material, disposable new material, or on pallets and racks. UEP does the same thing. It will be all-new material, like graded- loose will be new material, nest-run would be on racks with plastic or on disposables, which would be new disposables. And then, beyond that, all other material in our processing plant for some time, to my knowledge -- and I know at the USDA plants -- will go out in new material or plastic baskets or on dollies. But all those materials would be new. But most material today is new. It would be interesting to hear from those plants that are not USDA. I think you'd find probably the same thing. I know from the eggs they would buy off of ECI or UEP. Thank you.
MARILYN BALMER: Was there a question from the table here? Terry? If there are no more comments on this section, we'll break a little early for lunch. If you're in the hotel, check-out time is up until noon. Be back here at 12:35 promptly so to start the next section, please.
(Recess for Lunch 11:25 -12:35)
VICTORIA LEVINE: All right. This afternoon we are starting off with an egg products processing discussion by Roger Glasshoff of FSIS. Now, before we get started, I'd just like to remind you, if you're going to make a general comment at the end of today's session, please, go outside and register to do so. Thank you.
ROGER GLASSHOFF: Now that your stomach is full, you can doze off and you won't miss anything. This morning we spoke about the Action Plan and Strategy I which is the methods of reduction and the risk associated with SE and shell eggs marketed to the table market for consumer use. This afternoon we're going to address Strategy II which essentially is marketing eggs for further processing which will be subjected to lethal treatment which will essentially destroy salmonella.
I'm going to begin with egg products and then come back and talk a little bit about in-shell pasteurization. Currently the department is working to develop proposed regulatory changes, to incorporate HACCP as a basis for the Egg Products Inspection Program.
The approach on this program is to change from a prescriptive requirement that currently exists in our regulations to various instructions and policies which have existed over the last 30 years for egg products for the Egg Products Inspection Program.
Under HACCP, the focus will be directed upon verifying the effectiveness of processes and process controls to ensure food safety. With the incorporation of HACCP in the Egg Products Inspection Program, the agency will have then correlated its meat, poultry and egg products inspection programs to use HACCP as a basis for determining food safety.
Each company under HACCP will be required to complete its own written HACCP Plan. These plans will be individually tailored to the company processing procedures and the products produced. HACCP will provide a great deal of flexibility and innovation that allows a company to achieve a performance standard to produce safe food in a manner which will assure consumers that they will not be faced with problems of the food products for which FSIS has jurisdiction.
The HACCP Plan will identify the process and establish the critical control points. This is accomplished through hazard analysis. Critical limits could be established. Essential to the program is monitoring. Through monitoring, you would also identify any critical corrective actions necessary and, of course, record keeping and verification.
The key point here is record keeping. Documentation will be essential. USDA will move from monitoring individual aspects of processing to a verification and oversight procedure. The company will be responsible for monitoring in-process aspects and documenting their verification of compliance or conformance. The Plan will also describe who, within the company, is responsible for oversight of the Plan. The agency is interested in implementation of HACCP including documentation to demonstrate compliance with the sanitation, standard operating procedures, and establish performance standards. For the development of Performance Standard for Pasteurization of Egg Products, FSIS is seeking information on the enumeration of salmonella in liquid eggs prior to pasteurization. Currently we have some scientific information that could be as old as 30 to 40 years. Research that was conducted to develop the current relationship of time and temperature for the pasteurization of egg products.
We also have a risk assessment that was completed in 1988 which will be used as predictive modeling for the development of a performance standard. We mentioned the sanitation standard operating procedures. This is part of a prerequisite program. This morning, those that addressed you referred to your prerequisite components to a HACCP-based Program to reduce the risk of salmonella enteritidis in shell eggs destined for the consumer.
We would anticipate that in a true HACCP program, the processor would also maintain documentation from the producer as to what strategy they are participating in to reduce the risk of salmonella enteritidis. That would be part of the documentation that would be verified by our field operations staff.
We began speaking about producer-implementing components of the prerequisite programs, and one of the questions that still is at issue is whether or not environmental testing would be a valid component of Strategy II. Other issues are refrigeration as an intervention to microbial growth when eggs are not processed within 24 hours from the time of lay.
We heard previously about the aspects of the shell egg having inherent characteristics to inhibit the growth of salmonella. These issues would be addressed through the hazard analysis that is conducted by each processing establishment. We also heard this morning about the impact of eliminating the reuse of fiber and pulp packaging materials. In the egg products industry, quite frequently, materials are reused. We are seeing a trend, a movement towards, the use of plastic which can be cleaned and sanitized, but there's still quite a bit of the pulp-filler flats being used.
One of the principle record-keeping aspects of a HACCP Program is the identification of production lots. We have in the situation of diversion of eggs from SE-infected flocks, the requirement to assure that those eggs are pasteurized or treated in a manner to destroy salmonella.
In a processing plant where FSIS has jurisdiction, the company would be responsible for documentation of receipt of these eggs and the inspector would verify that they are, in fact, broken or treated in a manner to destroy salmonella.
We've also heard from a number of industry members that some of their customers are beginning to develop specification that restricts or prohibits the use of eggs that have been diverted from SE-infected flocks. We would like to collect more information with regard to that comment also. It definitely would have some influence on the price of eggs being marketed.
The basic time line for establishing HACCP as part of the inspection program is as follows: A proposed rule will be developed within the fiscal year. Hopefully, we'll achieve the clearances for publication in the Federal Register. Upon receipt of the comments to that proposed rule, we would determine when the final rule would be published. But again, we project fiscal year 2001. That final rule, of course, will address the implementation dates.
We have been urging everyone in the industry to utilize publications that are available from FSIS. Many of these, such as the Sanitation Performance Standard, are available through the Internet address which is posted here. As we develop the HACCP-based Inspection Program, many of the current instructions or prerequisite regulatory aspects of the program will either be changed or they will be converted to guidelines. These guidelines can be utilized in the development of the HACCP Plan if it is applicable to the process at a particular plant.
We would also envision the development of generic HACCP model which would assist the industry in development of their HACCP Plan.
Let's move on to in-shell pasteurization. At this time, this is the only process that we are aware of for the destruction of salmonella for shell eggs that are being marketed for table use. This process usually involves some type of water immersion for the destruction of salmonella. Again, we would envision a HACCP-based Program where the processor would again request the information from the producer of the shell eggs or the source of those shell eggs that are proposed for treatment as to what strategy they are participating. Will it be Strategy I or Strategy II?
That documentation would be maintained for verification and audit purposes. At this time it will appear that we will continue the performance standard as it currently exists for the destruction of salmonella in shell eggs that was established several years ago. Currently, it is referenced as a five log reduction of salmonella and it's derivatives. However, there may be a number of processing procedures that can accomplish that type of a performance standard. As you recall, under HACCP it allows plenty of freedom for innovation and flexibility. So the door remains open to development of various processes in the future.
One of the concerns of pasteurization of shell eggs is to ensure the integrity of the product as it is distributed to the market. Under such conditions, it will either be packaged to maintain the integrity or the individual eggs would be identified to ensure that the customer is comfortable that those eggs that are in the container have been properly treated. Packaging material, of course, would meet the labeling criteria established for shell eggs with the exception that the warning, or as it has been referred to "the warning statement", would probably not be included in the format of the label. Although the eggs have been pasteurized, the pasteurization process occasionally may only injure cells of salmonella.
So at this point we're still considering whether or not these types of products should be shipped under refrigeration to the retail level. Under the proper controls, that is a written description of the identity of a lot or the quantity that was processed, the containers would be identified for purposes of trace back. Under a HACCP-based Program, the company would be responsible for all documentation and verification of their process. The documents would demonstrate conformance on a continuing basis. It would identify oversight of the HACCP-based system maintained by each firm, and a USDA representative or designee would verify the pasteurization criteria of being met before the validated process as it is described.
And with that, I think we'll move on to the questions that we're seeking information to complete rulemaking.
VICTORIA LEVINE: We'll run this afternoon's session exactly like we did this morning. Let me remind you when you are commenting, please, give your name and your affiliation. Before we go on with the question, let's start with any general comments. Front table? Anybody in the audience? Yes.
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. I just want to make sure I'm understanding. You used the phrase "HACCP-based" with in-shell pasteurization, do you mean that it's a HACCP Program? And the reason I'm asking that is when working with a production system, we use the phrase "HACCP-based" to indicate that we don't have the guaranteed control that you did with food for astronauts where HACCP was originally applied. The principles are all there. We just recognize it's not a guaranteed control. Where as I would think with in-shell pasteurization, you would be much closer to real HACCP and could actually call that a HACCP Program. So are you saying that for in-shell pasteurization it's a HACCP Program and you just happened to use the phrase "HACCP-based" to indicate it's nature, or are you using it the way I do which means that it's not exactly guaranteed?
ROGER GLASSHOFF: Jill, I was referring the HACCP-based Program as it contains the aspects of HACCP including the lethal destruction of salmonella for in-shell pasteurization.
JUDY RIGGINS: Let me add my comments on that. We have not yet done the rulemaking. So we are not prejudging or predicting where we may come out in the rulemaking. What we do think is important is to have a system that embraces the principles of HACCP. We recognize in the packer area that we are forging new ground. We are sure of our path with respect to breaking and liquid pasteurization and we are going to propose a HACCP system for liquid pasteurization, pasteurization of liquid eggs, in processing plants. But with respect to packers, we are still exploring that.
We have shared with you our thinking about the use of performance standards at the packer level because understanding that this is not a monolithic industry and that there are a number of ways that a public health performance standard could be met, we want to give maximum flexibility in order to achieve that. So we are considering what options we might propose that would be HACCP-based in principle, but not necessarily as formalized at the HACCP system that we currently have for meat and poultry which we are extending to pasteurization plants. We don't want to prejudge where we are at this point.
KEN LOOPER: My name is Ken Looper, Cal-Maine Foods. Will the in-shell pasteurization have the same oversight? I know you just went through a description there that you haven't done that yet, but as I understand it, there is in-shell pasteurization going on today. Do they have an oversight plan or program?
JUDY RIGGINS: Roger, you need to speak up to this. But we are aware of two currently running operations right now. AMS is currently in each of those facilities because they are co-located at facilities where there is also grading. How we use inspection resources will depend greatly on where facilities are located. If a processor decides to co-locate a grading and an in-shell pasteurization facility in the same building, or in connecting buildings and AMS is currently there doing grading, then for us it would mean a better use of resources to have AMS conduct whatever inspection of in-shell pasteurization of eggs.
KEN LOOPER: An oversight will be the cost of the in-shell pasteurization company like in egg products that the federal funded?
JUDY RIGGINS: No. No. Let me explain. Under the Egg Safety Action Plan, the decision was made to redelegate, that the secretary of agriculture would redeligate to FSIS, responsibility for shell-egg inspection. It will not be a fee for service. It will be conducted as we currently conduct inspection in meat, poultry, and egg plants. So unless the administration proposes fees, user fees, and that passes in Congress, things will remain as they are. So it will not be a fee for service as far as we know now.
LOU CARSON: Let me also add a clarification. Currently, a processor considering in-shell pasteurization will submit documentation of that process to FDA to review from a technical standpoint. We then share our review of that process with AMS if that processor wishes to have AMS in the shield, then we work together with AMS on that process. Just as Judy has mentioned, in the future when the standards that we are proposing become final, then FSIS would oversee that entire process either in consultation with FDA or on their own.
VICTORIA LEVINE: All right. The first question we're going to address is Number 9 in the Federal Registered Notice. In the event eggs from an SE-positive layer flock are diverted from the table-egg market, what measures should be implemented to ensure those eggs are pasteurized? We'll start up front with Dave.
DAVID GLAUER: Currently, I believe the system is in place that when we have positive identification of an egg, it would fit into our law from an adulteration standpoint. Therefore, parts of ODA would be brought into that process that would track, with producer records, the effect of those eggs being diverted to a breaker pasteurizer.
MERYL SOSA: Meryl Sosa, from FACT. FACT is not aware of the proper steps necessary to ensure pasteurization of egg products. However, from an on-farm perspective, we believe records must be created and maintained on the farm to demonstrate compliance by the farm with diversion requirements. By maintaining such records for the period of one year, the farm can prove, in the event of an outbreak that it properly shipped the contaminated eggs to a breaker plant. By doing this, the farm insures that it will not be liable in the event of an outbreak and that the breaker will be responsible for any deficiencies in it's own pasteurization process. However, it should be recognized that pasteurization is not a substitute for a strong on-farm SE Risk Reduction Program.
And we'd also like to mention at this time that we believe that this area of the continuum represents the safest area of the farm-to-table continuum. And while there have been a few outbreaks resulting from improper pasteurization, this is a safe assessment because it includes a "kill step". Despite the fact that this area includes a "kill step", the USDA has chosen to employ 120 inspectors to inspect these facilities. But this proportionate quantity of inspectors is highlighted by the fact that FDA has only one person assigned to oversee on-farm issues related to eggs. And this example provides a clear illustration of the problem of having multiple agencies overseeing the issue of shell-egg safety.
TAD GROSS: Well, I think Dave and Meryl have covered most of it, but, again, I think the most important factor here is the paper trail that we need to create. You know, if we have eggs to be diverted that we can show to anyone that wants to see it that we are following the guidelines with verification of invoices back and forth. Sometimes it even comes down to sealing the trailers. USDA can become involved in that, but verification and a paper trail is the most important thing here.
VICTORIA LEVINE: Anyone else at the table?
DARREN MITCHELL: Darren Mitchell, Center for Science in the Public Interest. I'd like to reiterate in support with what Ms. Sosa said about the problem of resource allocation and too much resources going to the pasteurization process and too few to other areas which pose greater risk. And we would expect that if we don't have consolidation into a single agency for egg safety, that the resource allocation issue would be a primary thing that you look at in proposing the Egg Safety Action Plan.
VICTORIA LEVINE: The audience? Going once. Going twice. Okay. We will now go to Question No. 11. Do customer specifications exist that prohibit the processing of SE-positive eggs for egg products? Considering your production volume and available market for egg products, will this influence the price for SE-positive eggs? Tad.
TAD GROSS: This is a very important question from a producer's standpoint. Naturally we would be the first to admit if we have an SE problem that we need to do everything in our power to correct the situation. One thing that continually comes up or that I've been exposed to is diversion to a breaker. We also have breakers now that say that their customer base will not allow them to even process or put SE-positive eggs into their product. So as a producer, we get a little paranoid because we potentially are going to take in the past anywhere from four to six cents less for these eggs because of the potential SE problem.
Now if we lose that right or the potential to go to a breaker, that situation could even -- instead of four to six it could be double that. From our standpoint, we get very cautious about that and it has always been my feeling that pasteurization is exactly what the word means. It's to remove any bacteria. Hopefully, we can get everybody to agree that, yes, we can divert these eggs and work with them from there.
VICTORIA LEVINE: Meryl.
MERYL SOSA: Meryl Sosa for FACT. We have not had that experience regarding the SE-positive eggs, but from the breakers that we use for other reasons, for cracked eggs or what have you, they have not indicated to us that they would not accept those to kill their eggs. So we haven't had that experience yet, but possibly it's because we don't have as enormous a volume as other producers have. So that's one possibility. And, secondly, I guess, in speaking to it, the price differential would be, I think, about 35 cents at least for our eggs by going to the breakers. So obviously it would be a very difficult situation for us to address. And that's why we recommend that sometimes indemnification according to the guidelines that UEP has proposed.
VICTORIA LEVINE: Do you have any comments Dave?
DAVID GLAUER: No, I really don't. I think Tad has covered it.
VICTORIA LEVINE: Front table?
BOB ECKROADE: Based on my recollection of the Pennsylvania Pallet Program -- Is it on? Oh, thanks. Bob Eckroade, University of Pennsylvania and PEQAP. Based on my recollection of the pallet program, when diverted eggs went under a USDA red tag to the pasteurization plants, they took a bath. There was no doubt that the pressure will be on to pay far less for those eggs than normally would be paid for eggs going to pasteurization.
And while I think we have to do whatever is necessary to guarantee that the diverted eggs end up in pasteurization, I also agree that we have to do what we can to avoid a disaster for the fellow who happens to get caught up in having SE-positive eggs.
VICTORIA LEVINE: The audience?
LEONARD BALLAD: I'm Leonard from Ballad Egg Products. We're an egg-products company. We are not breaking SE eggs because there were three national concerns that have given us specifications for bidding on the breaking of SE eggs. We have or we know of other firms that will break them because there are no restrictions by their customers. On the other hand, there is no doubt that there will be a great economic disaster for anybody that has to send those eggs to an egg-products plant because of the fact that there are limited customers that take them.
DARREN MITCHELL: Darren Mitchell, CSPI. We're still investigating the indemnification issue and trying to decide where we come out on it. But I can tell you a little bit about our thinking process in hopes that it will you a little bit and that is: We like incentive-based regulations, and we think that the potential loss of profit is an incentive for improved management practices and everything else in the SE Reduction Program. Having said that, the question is: How much incentive do you need and does it really need to be full loss and shouldn't there be some partial indemnification?
So that's what we're grappling with right now.
JAY SCHUMAN: Good afternoon. I'm Jay Schuman with the Michael Foods Egg Products Company and we represent the Papetti's and M.G. Waldbaum brand name. Actually, we're going to be addressing this question. We're going to have a session with several of our different operations. We'll be addressing this in the written comments.
I was a little slow to the trigger to get up after the last question, Question 9, but I did want to, for the record, comment on Ms. Sosa's comment earlier. I just want to clarify one point. We do agree with Ms. Sosa that an aggressive SE Risk Reduction Program on the farm is very valuable and I think we've proven that. As Dr. Dutton has described, our program has been around for nearly a decade. And that is part of our entire integrated approach to pasteurized egg products. We do a full range, liquid, frozen, dried, precooked, as well as we are the innovators in in-shell pasteurization.
But the statement was made in passing. I don't want to let that go without challenge that egg products, pasteurized egg products, have been involved in cases or outbreaks of salmonellosis in humans. And to my knowledge, of all the literature, that has never been documented. And that's a very proud record of our industry ever since passage of the Egg Products Inspection Act of 1970. When we talk about egg products, we're talking about USDA-inspected pasteurized products under strict standards and specifications. I think sometimes we lose clarity when we use the words "egg product" when what we really mean to say is an egg-containing food or a complex food made using shell-eggs. So for the record I would like to challenge that. Thank you.
VICTORIA LEVINE: Anyone else? All right. The final question we'll address in this portion of the program is Number 17. Are the proposed components of the national standards for packing and processing of shell eggs and egg products appropriate and adequate to reduce the risk associated with SE?
DAVID GLAUER: The national standards that are proposed, I think, have many of the component parts to them that will reduce SE in shell eggs. Some of the comments that were made in the past relevant to the economic aspect really are also important in this aspect. But I believe that a set of records that assure the final destination of these eggs is important.
VICTORIA LEVINE: Meryl.
MERYL SOSA: We don't have a response.
VICTORIA LEVINE: No response? Fine. Tad.
TAD GROSS: I would like to speak for what I've seen that has happened here in our state here, in the State of Ohio. The awareness that we've taken back to the farm is getting these people involved with understanding what SE is, number one, and what they can do to help straighten this out, I mean, 5-Star Programs, what we document in our state and got everybody working on, I think the program that's in place has merit. I agree there's a lot of unanswered questions, but I think that everything is going in the right direction.
The farmer is kind of a different breed. You don't see them walking up and down the chicken coops with a laptop computer in their hip pocket, you know. So probably their worst thing to do is document stuff, and in our case, is to get them to understand that one of the most important things of any of these programs is to make record keeping a first priority. And I think as we continue to develop this education from the farm all the way to the store, and everybody pulls together, that what is being proposed by the 5-Star Program, the Pennsylvania Program, as well as Ohio's and anybody else's, they're all in the right direction and have a lot of merit and they continue to work for them. I think we can get this thing in order.
VICTORIA LEVINE: Anyone else at the table? All right. The audience?
KEN KLIPPEN: Ken Klippen with United Egg Producers. In answer to Question No. 17, the answer is, no. It's not comprehensive enough. There is more that can be done. And that's what the egg industry is trying to tell USDA and FDA right now. We need a uniform nationwide quality assurance program that assures consumers that our product is safe. The egg producers are trying to develop their own programs and trying to come forward with something that demonstrates uniformity.
The administration's plan doesn't go far enough as it relates to repackaging. I mean, it talks about conducting research on repackaging of eggs which is a practice that is not occurring universally, but it has happened in the past. We shouldn't study this practice, we should ban this practice. Repackaging eggs should not occur. And in the United Egg Producers Program, we actually are proposing that. And you'll hear that a little bit later when Ken Looper presents his comments. We should have stronger incentives to implement promising vaccination programs where rapid progress is taking place. We've talked about this over and over again about the plans putting so much emphasis on testing rather than putting emphasis on good quality assurance. The first question I asked today when I stood up here is: Why are we seeing reductions in salmonella enteritidis over the last four years? Nobody answered that question. I'll answer the question now. It's because we have quality assurance programs out there. And more and more people are participating. So the answer to Question No. 17 is, no, we need to go further, and we have some plans of actions that we're going to introduce today to suggest that. Thank you.
VICTORIA LEVINE: Meryl.
MERYL SOSA: Meryl Sosa for FACT. I'd like to take this opportunity to agree with Mr. Klippen on two of the points that he made. First of all, we believe that the plan does appear to include repackaging as a component. And while USDA/AMS temporarily prohibited the practice of repackaging and redating eggs, that prohibition at least currently would apply only to the one-third of the nations eggs graded and packed under the AMS voluntary grading program. FDA has not taken any measures to address this issue. And there are two key risk factors that can affect the growth of SE in eggs, age and temperature. And experts agree that an egg's natural defense to SE can break down as the egg ages or is exposed to high or fluctuating temperatures. Eggs that are repackaged must be transported to the processing plant and, therefore, may be subject to temperature fluctuations as well as additional heating during rewashing; therefore, ensuring that eggs are fresh and are maintained under a consistent, appropriate temperature from packing to the table. These are critical SE Risk Reduction measures. We would agree with you on the last point that you made.
DARREN MITCHELL: Darren Mitchell, CSPI. While we're adding to the plan, another lacking element is a required expiration date based on the date of lay. That's something that we strongly believe should be included in this plan and I would also like to agree with both UEP and FACT on the point of repackaging. It's something that we've argued long and perseveringly for. Thank you.
DANNY HUGHES: Danny Hughes with Arkansas Livestock and Poultry Commission. I have a question as far as egg products as it pertains to the shell-egg handlers. At the present time, they're not registered under the Egg Products Inspection Act as it relates to the eggs that are picked up at hatcheries, shell-egg plants. Will there be any restrictions on them where they're picking all these eggs up and then their destined for an egg-products plant for egg pasteurization? Will they come under temperature requirements, any age requirements or anything of that nature?
ROGER GLASSHOFF: Roger Glasshoff. Currently the Egg Products Inspection Act requires that all the eggs be of current production. Those records are to be available to the egg-products inspector as part of the documents maintained by the processor. As far as refrigeration, there's no refrigeration requirements on the movement of eggs currently from the producer level to egg-products processing plants. We haven't completed our rulemaking with regard to that aspect and it will probably be taken under consideration.
DANNY HUGHES: One more comment on the gaps in the food safety program as far as areas like food banks that are scattered all over the United States where they're receiving eggs from distributors that have been damaged for one reason or another; and then they are donated to food banks. I don't know if that's going to come under FDA or FSIS as far as the monitoring of these type operations or not. I know in Arkansas we've had some bad experiences with food banks. And I was just wondering if that was going to be a part of it.
LOU CARSON: That is a part of it and that would be covered by FDA.
DANNY HUGHES: One more and I'll sit down. The repackaging was brought up. What about the repackaging at the store level? Was that under consideration at this point?
LOU CARSON: We'll take that under advisement. I don't think we've talked about repackaging in the Plan per se so we need to look at it at all levels. There is a segment of the plan on retail. And so we'll have to look at repackaging at retail.
DANNY HUGHES: Thank you.
TERRY TROXELL: Terry Troxell, FDA. Darren, you said that CSPI believes that expiration dating is useful. If eggs are maintained at 45 or less, where outgrowth doesn't occur, could you elaborate on what public health benefit the expiration dating will provide?
DARREN MITCHELL: We see it as an extra measure of safety. The system that the Action Plan is proposing governed by several agencies. There's some gaps. We can not be sure that the eggs can be maintained at 45 degrees. We've heard comments about the post-production preprocessing time period where we could get some outgrowth. Things like that, we think, argue for an expiration date.
MERYL SOSA: Meryl Sosa, FACT. I'd like to respond to Mr. Troxell's question because at FACT we put out Nest Eggs. We also get the calls from Nest Eggs. And that is one of the most common questions that we get at our offices. And I'm not sure about AEB or UEP. But, how long can I keep the eggs; what is the expiration date; what does the expiration date mean? And they may not even ask us about our eggs. They may ask about other eggs. But we don't really know what other people are basing their expiration dates on. So there's this whole continuum of what the expiration date means that's on the box, because some people date it from the date of lay, some people date it from date of processing. Some people have 30 days. Some people have 60 days. It's just a whole mixed bag. And so I think it would be a great element for consumers to give them some confidence in the eggs because they would know the expiration date means from date of lay and I can keep the eggs for this many days in my refrigerator. And that's the way it is and I don't have to worry about whether the egg is from Nest Eggs or whether from Dominix or wherever they come from. They will all be the same.
VICTORIA LEVINE: Do you have a comment?
RICH DUTTON: Rich Dutton, Michael Foods. From a practical point of view, I'd just like to comment. I'm not sure if you're getting 30 or 40 lots or whatever. They may be eggs from a farm that just came in. Preferably it would be eggs by date where the next eggs are done. But there could be some lots that were two days old versus one day old. That would make a horrendous problem with trying to change the date on the carton.
I do have one other question. I am reluctant to bring this up. There are about 30 percent of flocks that are currently broken and designated breaker flocks. The question is whether those flocks are handled the same as shell-egg flocks? And the reason for asking that is we've identified rodents for being a source of SE potentially. Then breaker flocks, unmanaged, would likewise become a source. On the other hand, I realize that diversion allows the breaking of those eggs from those flocks anyway.
ROGER GLASSHOFF: One comment as a response. This is Roger Glasshoff with FSIS. As part of the HACCP System that would be implied for the processing plants with regard to pasteurization for egg products, we would anticipate that that HACCP Plan would include components of the prerequisite program which we are addressing for the producer. In other words, rodent control, in the case in which they were washing the eggs prior to shipping them to the breaking plant, they would be utilizing a proper source of water, things of that nature. But not necessarily environmental testing. Does that answer your question better?
RITCHIE LAYMON: Ritchie Laymon, United Poultry Concerns. Getting back to the repackaging. When Dateline NBC did their expose at Buckeye Egg on repackaging of eggs where the eggs were repackaged several times. Discovery of this situation wasn't made through federal inspections or state inspections, it was made because of a whistleblower. And I was wondering if there is a whistleblower contingent in the Plan here or if just the general federal whistleblower protection pertains here?
JUDY RIGGINS: Well, with respect to USDA or FSIS programs, yes, there is a general whistleblower provision that would apply to all employees and companies that are under inspection by FSIS which, of course, we do respect and take seriously. So, yes, the answer is when we extend our inspection authority to packer facilities, the whistleblower provision would also apply to them as they do currently to egg processing and meat and poultry slaughtering processing.
VICTORIA LEVINE: That was Judy Riggins.
LOU CARSON: This is Lou Carson for FDA. Obviously, as we would receive any information concerning the safety of a product, we would follow up on it whether it's whistleblower or other means. So it would be the general procedure that we would follow. Any information we would be responsible in following up on.
VICTORIA LEVINE: Any other comments? Moving right along. We will now hear from Nancy Bufano who is going to give us an overview of retail food service and consumer issues.
NANCY BUFANO: The last segment in the farm-to-table continuum is the retail food service and consumer segment. Or I should say, the last, but certainly not the least segment in the farm-to-table continuum. I'll start with the discussion of the retail and food service segment. FDA is considering codifying certain egg-related provisions of the 1999 Food Code. One of the first provisions that the Food Code talks about is temperature and condition of shell eggs upon receipt at retail.
If these provisions were codified, they would require that shell eggs received at retail would be at 45 degrees fahrenheit or below, be clean and sound, and not contain more restricted eggs than allowed in U.S. Consumer Grade B. The temperature for holding shell eggs at retail will be addressed by FDA's final rule on labeling and refrigeration of shell eggs at retail. This final rule will be published later this year and I'm sure most of you know that the proposed rule which was published in July specifies this temperature as a 45 degree fahrenheit ambient temperature.
All liquid, frozen, dry eggs, and egg products received at retail would be required to be received pasteurized. Four retail establishments that specifically serve at risk consumers -- here we're talking about your hospitals, nursing homes, and day care centers -- these establishments would be required to substitute pasteurized eggs or egg products for raw eggs in menu items that either traditionally contained raw egg ingredients and are not subsequently thoroughly cooked, or are prepared by combining or pooling and then holding eggs prior to service or are prepared by holding eggs following cooking prior to service. And then, additionally, soft-cooked eggs and meringue made from raw shell eggs would not be allowed to be served for retail establishments that do not specifically serve at-risk consumers. And, just for clarification, this would include family restaurants and bakeries, ect. Raw eggs would have to be served fully cooked or the establishment would be required to substitute pasteurized eggs or egg products or raw shell eggs in the preparation of foods that traditionally contain raw-egg ingredients and then are not subsequently fully cooked. Or if the establishment is going to serve or offer undercooked eggs or food containing undercooked eggs, they would be required to inform consumers of the increased risk that consuming those types of foods pose to at-risk consumers.
So FDA will be crafting consumer advisory language for those retail establishments -- and those are the ones that do not specifically serve at-risk consumers -- language for them to use to inform the consumers of the increased risk that consuming raw or undercooked eggs poses to at-risk consumers.
The very last segment of the farm-to-table continuum is obviously the consumer. FDA is not going to regulate the consumer, but we want to make you aware of the current food safety education efforts that have been underway, that are underway, and that will continue and will be strengthened. FDA has published two fact sheets, one for the consumer, one for food service relating to eggs. I believe they're both in your packet. They're also on the display in the back, the Fight BAC! display. These fact sheets explain that salmonellosis is associated with fresh eggs and they explain who is at high risk. They outline safe buying, handling, preparation and storage of eggs and egg dishes, and they explore the hidden risk in foods containing raw or undercooked eggs, and how to avoid them. These fact sheets have been widely distributed to the media; 82,000 day care centers; 22,000 school district food service directors; 13,000 nursing home directors. They are posted on FDA's web site which is FDA.gov. They are available from FDA's food safety hotline, 1-888-SAFEFOOD. And the consumer fact sheet was included in the 1999 National Food Safety Education Month Consumer Education Planning Guide.
FDA has also developed a video news release which alerts consumers to the potential risks of undercooked eggs and egg foods and the simple steps they can take to avoid these risks. This was produced and distributed last July at the same time FDA's egg-labeling-and-refrigeration regulations were proposed; and this video news release has been carried by 18 stations with a viewership of 2.5 million.
We've also developed two feature articles on egg safety, one in English, one in Spanish which have been distributed to print media nationwide, and these have appeared in -- Howard Seltzer who is sitting at the table who is with our food safety initiative education staff, he just updated me that it is now over 1200 publications and a readership would be more than 74 million.
The Fight BAC! brochure which is also included in your packet and is also available at the Fight BAC! display in the back of the room also includes safe egg-cooking information that has been widely reproduced and distributed both in English and in Spanish as part of the Fight BAC! campaign and it is also available on the Fight BAC! web site the foodsafety.gov web site and FDA's food safety hotline.
And lastly, FDA has developed in conjunction with USDA has developed a patient handout for physicians which is currently under review. It includes both safe cooking information and the identification of persons at risk of foodborne illness from raw or undercooked eggs. It is developed for the American Medical Association, FDA, USDA, CDC, physician food-safety initiative. And with that, I will turn it back over to Vicky, and I'll leave you with the retail food service consumer discussion questions.
VICTORIA LEVINE: Again, before we hop right into the questions, are there any general comments?
KEVIN KEENER: Kevin Keener, North Carolina State University. My question is in regard to a lot of the educational materials and things that you've developed, have those been distributed some of the cooperative extension type services?
HOWARD SELTZER: Howard Seltzer, FDA. Yes. The Fight BAC! materials particularly have been widely used by cooperative extension. I don't know if they have at North Carolina State, but I know they've been distributed literally by the tens of thousands through extension. The egg fact sheets I don't have that much data on. We send the National Food Safety Education Month Planning Guide to extension agents all over the country, to our own public affairs specialist, and last year to school-food service directors and to a lot of other people, the idea being that they would then use these guides to develop activities at the local level.
So, I would say, to a large extent, yes, they have been distributed through extension.
KEVIN KEENER: Okay. Thank you.
VICTORIA LEVINE: We are going to start with Question No. 18 in the Federal Register Notice. Do the provisions in the 1999 Food Code which apply to shell eggs adequately protect at-risk consumers in retail establishments? If not, what other provisions are necessary for their protection? Let's start with Tad.
TAD GROSS: I guess my comment on this question would be there's a very big need for education at the retail and institutional level. I mean, as an egg producer, and as someone who sometimes has to be forced to make deliveries, you pull into a restaurant or institutional place of business and put your eggs in the proper part of the refrigerated cooler and decide to have lunch and go in and come back out find your eggs sitting outside and the chickens went in. Again, as an egg producer, frustrations come out of my fingers. I'm saying, "What did I do here?"
But it's not only a situation that the Food Code may have enough in it. It's for everybody to understand that the necessities to follow that Food Code to ensure and to help ensure the producers that we're doing our part and we need to go up to that end of it. So education to me is one of the biggest things here that needs to go through the system. And, obviously, they're doing this with the Fight BAC! But to me, it's very important.
VICTORIA LEVINE: Meryl.
MERYL SOSA: My name is Meryl Sosa, I'm manager of Food Safety Programs for FACT. We do not believe that the Food Code is an adequate solution for providing protection to at-risk consumers in retail establishments. And during Ms. Bufano's discussion she mentioned that the USDA and FDA are considering codifying the Food Code.
And by that I assume that means that they are going to put it into a set of regulations. We would definitely encourage that thought. The Food Code is only operable in states that have adopted its provisions. States currently are free to adopt any or all of the provisions of the Food Code. The GAO, in preparing its Egg Safety Report, found that 24 of the 50 states did not require food service operators to serve highly susceptible populations pasteurized eggs or any food items that usually contains raw eggs such as Caesar salad dressing.
Further, the Food Code is not a federal regulation. It only has the force of law when it has been adopted by a state or local governmental entity and when sufficient penalties are imposed under the adopted provisions and the state adequately enforces such provisions. Thus, the reliance by the FDA on the Food Code as a method of protecting the safety of food is completely inadequate. Regulations should be included as part of the Egg Safety Action Plan that provide adequate protection for at-risk consumers in retail establishments rather on relying on the hit-or-miss approach offered by the Food Code. It cannot be emphasized enough that the Plan is an opportunity to provide a comprehensive regulatory approach to the issue of egg safety, providing regulations that truly govern all aspects of the farm-to-table continuum.
DAVID GLAUER: Dave Glauer, Ohio. Again, I think producers, for a period of time, have been held to refrigeration standards. And I believe that by codifying at least the principles that are here within the Food Code do bring the next level of the whole farm-to-table continuum that will help reduce foodborne contamination.
VICTORIA LEVINE: Comments from the front table?
DARREN MITCHELL: Darren Mitchell, CSPI. I also encourage the adoption of the Food Code provisions, its regulations. It's something that we've been pushing for across the board throughout the Food Code. And, actually, Mr. Gross' comment on the training, that sort of arises there again. At this year's Conference for Food Protection, there will be a certification program, a training program for managers at the retail level. If that's not part of what's codified for egg safety, it's not going to happen in many, many jurisdictions.
So as much of that as you can get into this plan as well, would be extremely helpful, I think.
VICTORIA LEVINE: Any other comments? Anyone in the audience?
KEN KLIPPEN: Ken Klippen with United Egg Producers. Is this how we address problems is with more regulations? More regulations trying to command and control people who just by implementing common sense -- I'm going to pull some figures that were given earlier. In food preparation areas between 1985 and 1999, 87 percent where there was an outbreak occurrence, it was in restaurants, health care facilities, schools or churches 87 percent of the time.
In those occurrences where they were able to identify the vehicle, 45 percent of the time they identified eggs. Now let me just share with you an FSIS document that says salmonella serotypes isolated from raw meats and poultry -- January 26, 1998 to January 25, 1999. And this is where the agency identified 1,174 positive isolates from large plants subject to pathogen reduction testing requirements. And then, of those, 903 they actually serotyped. And it's interesting to reflect on this identification.
In the boiler plants, the salmonella isolates of serotypes, they had upwards of 31 percent salmonella, Kentucky; 17 percent salmonella, Heidleburg; you go down the list. You get down to salmonella enteritidis, 2.4 percent in the ground beef or the beef plants. You had upwards of 19 percent salmonella isolates. You get into the pork.
VICTORIA LEVINE: Mr. Klippen, could you make the connection for me?
KEN KLIPPEN: The point is, that the incidence of salmonella enteritidis in eggs is .005 percent. That is the risk. And the reason why we don't see this happening is because people are using common sense. They are cooking their food. And that's what we are saying is cook your food. If we can just educate people, that is the most important element in all of this is to educate people to handle this food properly. And once they cook that food properly, then we're not going to have a problem. We're not going to need the warning labels that are being proposed. We don't need to alarm consumers. We need to educate consumers. And that was the point.
VICTORIA LEVINE: Thank you.
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. I would give a yes and a no answer to that question. And there is so much complexity on the subject of food handling, food preparation, and specifically egg preparation that I'd urge the agencies to consider the retail end of things and the food handling in a more amplified light whether it be a meeting, another public meeting, or a separate Task Force. But this is classically where food protection has the biggest problem. And I'm going to give a couple of examples of that.
But I cannot cover, in the few minutes that I know you want me to limit my comments to, all of the aspects of this that I could. I'll try to do that in written comments. I'll speak more to it in Sacramento also. But that's my first point is there is so many nuances and subtleties on this that I'm asking for more emphasis and thought on the food service end of things.
To give some examples to that effect then, let me state that the United Egg Producers was very supportive of the use of pasteurized product with at-risk consumers. So there's no objection to these concepts that are coming through Food Code from the viewpoint of needing to protect individuals and work in collaboration with this end of the chain. So we're supportive of that. I am finding that there are lots of instances where it's inadequate and does not cover the specifics of the situation. And I'll work with the Conference for Food Protection in Milwaukee to that effect and any other mechanisms that we can.
A couple of examples. The food handling practices in nursing homes presumably have changed because we don't have near the number of outbreaks or the numbers of illnesses associated with that demographic group that we used to when we first discovered this issue. So there's been a change. But the outbreaks that we now have in this instance, they are usually egregious food handling practices, the gloved hands, cutting up raw animal product and then tossing the green salad with the same gloves on those hands.
So this cross-contamination issue and the food preparation practices, those types of things are not going to be addressed by this type of thing whether it came originally from an egg or a non-egg source. The egregious practices is what's coming through in that particular at-risk population. Another example is the at-risk population of the young. Salmonellosis typically hits those below age one in large numbers. With SE, it's about 25 percent of those under age 10.
And so I think we have a greater need in working in food protection to tie in the specifics of that epidemiological information than with our education and action plans both at retail and consumers. We're not necessarily addressing either anybody in a restaurant or anybody in a consumer situation of spreading a product, contaminating a counter, and then putting the baby's nipple or baby's bottle on that counter top without a disinfection of that counter top in between.
So these are the types of specific things that these broad recommendations that are coming through Food Code aren't going to address. And I'm assuming that you mean the receipt of eggs at 45 degrees ambient in coming in as the recommendation. And, again, going back to the speed at which eggs are delivered from the producer to the retail establishment, the natural protective properties of the intact shell egg -- so that's pretty well covered, very well covered with 45 ambient. But we're not covering the temperature of that egg in that restaurant once it's broken out and pooled.
Is it kept on the line, in a pitcher, unrefrigerated before it's turned into a scrambled egg or a french toast or an omelette or what not? Is it handled in a fashion such that that pitcher or that container that's making the french toast is cleaned periodically or simply the next batch comes in? So you can see I could go on and on with the examples, and, given the chance, as I work with you individually, I will. So I will try to list some of the specific examples. But my key point is that this is a very broad subject and I think, certainly, it's a good start with Food Code and consumer education, both, on the things we need to do.
I'm going to do one more example. If we really want to come up with blocking disease transmission, we've got to look at the epidemiological information and pie it into our messages. Nowhere do I hear being addressed frozen casserole that is taken out and put in the oven without the oven being preheated first. Or a thermometer inserted in the middle of the deep dish casserole so that we see that we actually get the temperature there. The hollandaise sauce that was made without a thermometer making people sick. But, in the same restaurant upstairs, same machine, same eggs, the only difference is the chefs upstairs used a thermometer because they were chefs and not short order cooks. Those people didn't get sick, the others did. So we've got a lot of things that we could be doing and it involves a little more detail and specificity than we've got a start on here.
TERRY TROXELL: Terry Troxell, FDA. Follow up so that I understand correctly. Then the position of the UEP is that -- I mean, you said about supportive of the concepts of the Food Code, but are you supportive of the need for the Food Code egg provisions being codified so that we can get greater adherence to that, the refrigeration and the cooking, or as Ken said, this is a necessary command and control? Or was that just with respect to the warning label? Would you please clarify?
JILL SNOWDON: I have to let UEP respond to that directly as I'm providing technical and scientific information for them. So I'll let them respond to the specifics of that. I simply wanted to make a point that we are supportive of the concept of protecting at-risk populations and using techniques to do that.
KEN KLIPPEN: Ken Klippen, United Egg Producers. We're supportive of enforcing whatever regulations are that are adopted. If we do go along the lines of codifying the model Food Code, then it must be enforced uniformly. That's why we're asking for uniformity within the egg industry as well, a uniform enforcement. That's all.
It's just that it's frustrating to us to see the predominant area where there is abuse and not to be directing the attention to that immediately. I think Tad said it well. He's frustrated. We're frustrated when we see this area not being addressed as rapidly as we are focusing on the farm. And that is such an important element when you look at the tremendous contributing factors being the abuse at the restaurants and food service establishments.
VICTORIA LEVINE: Any other comments? Our next presentation is by Robert Scharff. And he is going to talk about the role of economics in the rulemaking.
ROBERT SCHARFF: Well, we've heard a lot about costs today. We know a lot of people have been talking about that and we know a lot of people don't like hearing that, but as an economist, I have to say that I love hearing about that. So you can keep talking about it as far as I'm concerned. Anyway, as I said, I'm an economist. I work at FDA in the Center for Food Safety. And I'd like to talk a little bit about how we analyze regulation from an economic point of view.
We basically are required to analyze regulations based on two requirements. One is the E.O. 12866. That's a standing order by the President. And that's what requires us to do cross-benefit analysis, regulatory impact analysis, things like that. The other is the Regulatory Flexibility Act of 1980 as it's amended by the Small Business Regulatory Enforcement and Fairness Act of 1996. And what that requires us to do is to look at the impact of any rule on small businesses.
Going a little deeper into E.O. 12866, the Executive Order says, and these are quotes, each agency shall assess but the cost and benefits of the intended regulation. And I know there was some concern earlier today about, you know, that we were just talking about cost and that we were not going to include the cost to the consumer of SE. And that is something that we are going to look at and we are going to include in our analysis.
Furthermore, each agency shall base it's decisions on the best reasonable attainable scientific, technical economic and other information. Now, we have pretty good resources with regards to trying to get this kind of information. We don't know everything. You are really the experts in a lot of cases. So anything you can tell us is very useful. We're also required to identify and assess alternative forms of regulation and tailor our regulations to impose the least burden on society. The regulatory impact analysis, which I talked a little bit about before is what comes out of this. This is the report that the economists write. This is true at both at FDA and FSIS. As I said, that's required by the E. O. 12866, and in that we assess the positive and negative impacts of the rule.
So we will look at what SE reduction will occur from the rule, but we will also look at what it will cost the industry. And this is written by economists with input from agencies, scientists and policy makers.
Now, for the Egg Safety Action Plan, the benefit that will be discussed in the RIA will be the reduction of illness due to SE in eggs. Pretty straightforward. The costs of the Plan are going to be the increased expenditures due to the implementation of the Plan's components. I listed a few of these.
Now, it's important that you look at that word "increased". I italicized it and underlined it because it's important. If people are already doing things, that's not considered a cost by the agency. So if you want to report what the increased cost will be to you from this Plan, not what the total cost is going to be.
Now, the Regulatory Flexibility Act of 1980 requires that agencies assess the impact of proposed regulation on small businesses in something called the Regulatory Flexibility Analysis. That's also a report that we put out. That's actually written at the same time as RIA. And it provides for the participation of small businesses in rulemaking through notes in the Federal Register, public hearings and review in response to comments. That's part of what this meeting is all about. We're talking to large businesses, but we're also hoping that there are some small businesses that are represented here as well.
Now, this next flag, I labeled it -- How should small businesses comment? Now, this is true for everybody, small or large businesses who are going to comment. You should submit detailed information that will assist us in assessing the value of the proposed rule. And you should also submit detailed information about your company. Recognizing that we've become publicly available, everything that you give us goes into our docket. So anything that's proprietary that you do not want getting out to the public, you don't want to give us. But if there's anything that you can give us that's detailed information about what your operation is like and what the cost to you would be, that's great, we want to hear it.
Comment's that provide little detailed information are not useful to the agency. This rule will put us out of business. People often write comments like that. That's not as useful as telling us about cost structure of your farm and how it's going to be affected and why it's going to go out of business or it is going to go out of business. At the FDA, we have several resources to help you make comments which came in the packet you were provided with this guide. It's a guidance for small business. As I said, it's also relevant for large businesses and submission of comments for CFSAN rulemaking. And it basically goes through detailed instructions on how to make comments and what comments will be useful to us.
We also have a web site where the same brochure is located and the address is there if you would like to write it down. Also, one other thing about this, I have a number of these guides, so if you are a representative in a state and you'd like to distribute some of these, I can give you a few. I don't have a whole lot, but I have a few of them. Another thing we have is a small business hotline. The phone number is located on the back of the guide. This is meant for small business, it's not for large businesses. And the purpose of this hotline, is to aid small businesses in making comments that are going to make sense. Because, often, small businesses do not have the expertise in regulatory work to know what exactly would be useful. So, what we will do if somebody calls is say, if you give us this information, this information will be recorded and it will be useful to us.
The one thing I want to stress is we cannot use this hotline to record comments. So if you call up this hotline and say, well, we have this cost structure and this is happening, it's not going to be recorded. It's not a good way to make comments. The hotline is there purely to assist you in making your comments. And, I guess, that's it.
Excuse me. One other thing. Since we were talking about comments, in the Federal Register Notice for the meeting, where to send your comments and how to technically make the comments is listed under Part 5.
VICTORIA LEVINE: All right. It is now time for a short break. I have 2:05 on my watch, so we'll reconvene at 2:15.
(Break from 2:05 to 2:15.)
VICTORIA LEVINE: Apparently there were a few questions for Bob. So we will recall him to the podium. Ms. Laymon.
RITCHIE LAYMON: Ritchie Laymon, United Poultry Concerns. I had a question for Dr. Scharff about other costs involved in the economics of this. If the National Centers for Infectious Diseases can be believed, the actual cases of salmonella enteritidis are 38 times the reported cases. So that's a lot of people running off to the emergency room in the middle of the night and missing work for several days. Who does the economics of the costs beyond the producer to the consumer and to the tax payer?
ROBERT SCHARRF: We also do that. If you want to get an idea of how we do it -- I'm not sure if it has been released yet, but I know when the final rule comes out for the refrigeration rule for eggs, we did an economic analysis where we did both sides of the costs and the benefits. We looked at salmonella and we measured the value of illness and hospitalization and death that results from salmonella. So we do include it. Any other questions?
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. Is that posted or available? That analysis?
ROBERT SCHARRF: I'm not sure. Does anybody here know?
TERRY TROXELL: Terry Troxell. Certainly, the proposal on the egg labeling and refrigeration was out last July and their Egg Impact Analysis for that was out thereabouts.
JILL SNOWDON: I'll check that again. And that included the specifics on the cost of illness too? It did, didn't it? Thanks Terry.
MERYL SOSA: Meryl Sosa for FACT. You mentioned that as part of your analysis you just wanted the increased costs that people would incur. Now, in getting the information that you need, will that be somewhat difficult by the fact that some people are already in these quality assurance programs? They're different? Each program is different. I'm just trying to figure out how that's going to play into it.
ROBERT SCHARRF: That's a very good point. I guess I should be a little bit clearer on that. There are some places where some people are doing something and other people are not doing it. In those cases the people who are not doing it would probably be the ones who want to complain about the costs or write about the costs. And they would just say, okay, well, it's going to cost me "X" amount. The other people who are doing it, they may want to say that they're already doing it. We will try to determine through other means how many people are in compliance or not in compliance with different provisions.
But there are other components where there may be an increase in something. So for example, if you have an SE-positive flock, one of the things that has been talked about is increased rodent control. And there are some things you can do for rodent control that you were not doing beforehand. We're not looking at the total cost of your rodent control problem. We're just looking at the cost that would occur due to this rule from the increased rodent control. So, you're right. It depends on what we're talking about whether you want the total cost or whether you want just the incremental cost.
But, when we measure it, we're going to measure everything as incremental costs and some of them will be weighted averages. So it will be the cost say -- Let's say you already have a testing program that's the same as what we end up doing. For you the cost will be zero. For somebody else, the cost will be the full cost -- somebody who's not doing anything. The weighted average is the incremental cost in that case. So it's a little bit confusing but it's the same principle.
BOB ECKROADE: Bob Eckroade, University of Pennsylvania. As someone who has worked for years with producers convincing them that certain practices carry with it great benefits for more than the single disease than they're working at, I've always said that the investment in education that we just spoke about of the consumers and the cooks and what have you, would not just eliminate salmonella enteritidis; it would reduce all the others. And so we get way beyond what that investment would bring us back for the E.coli and the shegellas and all of the others by simply educating them to handle food properly.
And I don't know whether you can put a value on that. But I would like to re-emphasize that I think the dollars spent there is going to pay back tremendous benefits in food safety in general that we may not get into. But it's going to have that effect.
ROBERT SCHARRF: That's a good point. There are going to be some external benefits. When we try to reduce salmonella, we reduce other pathogens as well. Because the purpose of this program, however, is salmonella reduction and because of the complexity of trying to answer the question of what else is reduced, we're probably not going to do an explicit analysis of that; however, if anybody wants to send in comments about how other pathogens could be reduced through this program, we'd be happy to at least qualitate that we mentioned that as a positive side effect.
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. I don't get it. I don't get that the producer that has been an industry leader, gotten ahead of this, done a quality assurance. His costs are not included because he's already doing what the federal government plans to do for everybody else. And the person who said, I don't know what's expected of me and I don't want to proceed until I know what's expected of me, his costs count?
ROBERT SCHARRF: I understand that does sound unfair. But, in fact, what we are doing is we are trying to analyze what the effect of the rule is going to be. Basically, it cuts both ways. The benefits from the guy who is already doing the right thing, those benefits have already been realized. We've seen a tremendous decrease in SE in the last few years and it's because of the guys who have been responsible and who have pulled their act together. Those benefits are not going to be included in the analysis. It's only going to be the increased benefits that will accrue due to the rule and the increased costs that will accrue due to the rule that are going to be in the Regulatory Impact Analysis.
JILL SNOWDON: So we've had the 50 percent reduction already without federal regulation and that part is not going to count?
ROBERT SCHARRF: Not for this rule. Because that's happened in the absence of this rule. We're only going to look at what this rule --
JILL SNOWDON: But this rule was necessary?
ROBERT SCHARRF: Yes.
JILL SNOWDON: I'm getting a needle here because this is not motivating to an industry to say all that investment that you've put in just doesn't factor into the economic analysis.
ROBERT SCHARRF: It does, in fact, because it gives us some information about how well the steps they have taken -- what the effects of those steps have been. And we have seen this tremendous decrease in SE. And from that we can project, what the additional decrease in SE will be from requiring everybody to do it. So in a sense, they've laid the groundwork for this rule.
TERRY TROXELL: Terry Troxell here. Jill, you may recall CDC's presentation that there's over 200,000 illnesses. So there is need for further controls and I think everybody has been arguing for some national uniform consistent approaches so that those people who have taken the steps to use best practices will not be paying a penalty so to speak because of those people who have not.
So we're trying to get everybody up to the same level. And the baseline we're at right now is what today is and the impact of the rule will be, whatever the effect it will have, once it's implemented. That's the way costs are done, otherwise we go back a few years ago where we had 600,000 cases estimated and the health impact of that. So that's the way the economics are done for all rules.
JILL SNOWDON: Perhaps my suggestion is more of an academic one, Terry, I think somewhere along the line, we need to model the sense of the economic burden on food production relative to the ultimate public health benefit and not as "is it worth it". Because, certainly, even one illness is too much. So, yes, it's always worth it, but in terms of are we directing our resources at production at the most efficient mechanisms to give the public health benefit from it. So I'm being a little bit of an agitator here because in terms of the economic burden that gets passed on to the consumer, that's not being realized in this type of analysis.
And I think what you're telling me is it's not appropriate to this type of analysis because you're only talking about what's changed. So my suggestion may be more of an academic research one than pertains to regulation making.
PHIL DEBOK: Well, I just wanted to interject a cautionary comment here, at least, from the production side of the house. Currently many of the major egg producing states already have upwards of maybe 85 or percent or more of their production already enrolled in quality assurance programs that are similar to what we are talking about mandating here. And I'm not sure that enrolling the other 15 percent is going to make a significant reduction over what we've already seen. So you need to take that into fact. Because doubling the effort here is not necessarily going to cut your cases in half as a result.
VICTORIA LEVINE: That was Phil Debok.
ALICE WALTERS: Alice Walters, Ohio Poultry Association. I guess I'm like Jill here, it's a matter of academic research, but in your own safety plan, it states you're going to use the data compared in 1998 baseline values, not currently. So I would call upon you to compare those 1998 baseline values and also put into that analysis what people are paying currently that are in the program. Because as Phil states, we do have a large majority of the largest egg producing states on a program like this.
So if you're going to an economic analysis you need to include those figures in this analysis.
VICTORIA LEVINE: Anyone else? Good. Speaking of research, that is our next topic. Robert Brackett.
ROBERT BRACKETT: One of the important provisions of the Egg Safety Action Plan has been from the inset that the recommendations and the policy that come out of it are to be based on sound science and sufficient scientific data. And during the creation of the plans, a number of different data gaps were identified that would need to be addressed in order to do this.
The overall research questions addressed in the Plan that were suggested were based on these gaps. And just as sort of a review of what the Plan entails, as has been stated all the way through the data, through the two strategies: Strategy I, which deals primarily with controlling SE at the production level versus Strategy II, which is to focus on the lethal treatments to eliminate SE in eggs.
And this is important for a research point of view too, because the way in which you address the research will be fundamentally different depending on which of these two strategies that you are addressing. And it's also important to the research to remember the overarching goals to the whole plan which is to eliminate all egg-associated SE illnesses by 2010 and to also meet the interim goal of reducing by 50 percent egg-associated SE illnesses by 2005. And this will also impact the research that's chosen to be done.
The mechanism that has been selected for reaching both of these goals are addressed in eight objectives and they are listed in the plan that you have. The one that I'm going to focus on, obviously, is Objective 7, and that is to ensure adequate current information is available to make decisions about SE, preventative controls, the surveillance and the education; and that, again, is based on sound science.
From this, four sub-objectives were identified. And when you look through the Plan, it sort of looks like these are just a list, but, in fact, there are some organizational reasons for this. The first research sub-objective which I call 7.1 here is to develop and evaluate on-farm intervention strategies as far as technology. And this primarily addresses Strategy I, that is, on-farm control. And it would include such things as forced molting and other stress factors, vaccines and immunomodulators, SE- competitive exclusion and such technologies as ion air scrubbers in hatcheries. Now with this objective and those that come after it, these were the initial identified tasks or gaps in the data that were needed to enact the Plan.
These are not the only things, and as good research usually does, as more is learned from this research, they may be changed, they may be addressed and new ideas may come from them, and that's the way research should work. The sub-objective 7.2, the second one, was to address and to provide additional information about the commercial processing technologies and practices for reducing SE in eggs.
Obviously, this addresses primarily Strategy II and it would include research on such topics as in-shell pasteurization of eggs, rapid cooling before and after processing, the issue of continuous re-washing and re-packaging, pasteurization of egg products and additives. And the first thing that you might notice is that even though we're into the year of 2000 here, that several of these have already been addressed. In fact, there have been publications on this and these are moving more towards commercial and practical applications; that is, in-shell pasteurization of eggs and pasteurization of egg products and additives. So as these are addressed, of course, we may have new questions and new ways of doing this.
The third sub-objective involves improving testing methodologies for salmonella enteritidis on farms and in eggs including identification of virulence factors and development of rapid tests, screening tests, sampling protocols for sub-typing SE isolates. Now, this particular sub-objective really provides tools that could be used both in Strategy I and/or Strategy II.
And finally, the fourth sub-objective that was identified are those that again would address both Strategies I & II, but were more of a fundamental or long-term nature. And this will be shown by the time line. And this is to understand the ecology and the epidemiology of SE in the hen and farm environment and includes such research topics as the sources of SE in the environment; the actual mechanisms of colonizing; how these organisms colonize the layer house; factors affecting the infection of the hens and the contamination of eggs mechanisms; pasteurization again, characteristics of salmonella enteritidis that promote infection of hens; and then more of the fundamental topics like biochemical characteristics; immunological and other factors that affect humans in their infection; and risk factors associated in humans that affect infectivity as well.
One of the research issues that all of these have to address and these are the issues that are taken into account by both government as well as academic and industry researchers first of all is the immediate versus long-term results. This goes back to remembering the interim goal of reducing by 50 percent SE by 2005. Some research is geared long term such as the fourth sub-objective; some is much more applied and can be used right now. And that's where most of the research has been addressed so far.
There's also the issue of practicality and economics of the solution which was addressed by Bob previously. And then one also has to ask the question of who is best to conduct the research? Some types of research are best done by government, some by academia and some by industry. And it's when the three different groups together work and share the research results that the research questions become answered.
And so the whole idea of the research component of the Food Safety Action Plan must consider these three particular issues as well as some others, and be understood to be sort of a moving target or a progressive type of situation where research in the future will be built upon the research that's done now. And that is all I have to say.
VICTORIA LEVINE: All right. Shall we start with any general comments?
KEN ANDERSON: Ken Anderson, North Carolina State University. Simple question, who's going to pay for this research? It's extremely expensive to do long-term studies dealing with issues such as molting and what effect it can have on the microbiological characteristic. Who is going to pay for it?
BOB BRACKETT: This is Bob Brackett, FDA. It turns out that as was shown in the last one, it's going to end up being that everybody pays for it. Some of the programs are going to be addressed in the form of government-competitive grants, as has been done. Much of the research that already has been done has been paid for by industry, quite often, through universities; and others have been done within different state programs that have paid for salmonella enteritidis research for research as well.
JUDY RIGGINS: Judy Riggins, USDA. As a part of the Food Safety Initiative, one of the areas that the administration or the sister regulatory agencies are collaborating on is research. And the intent is that for each budget year, each fiscal year, when we do our budget formulation, there will be collaboration among the agencies first of all to decide on the priorities. Obviously, SE is one that has been identified as a priority. The agencies will come together and agree on an agenda for not only government research, but also for grants and other mechanisms that would engage the private sector. So it is something that is an ongoing operating agreement among the regulatory agencies with respect to research for food safety. So it's being included in that umbrella.
JILL SNOWDON: Jill Snowdon, Egg Nutrition Center. Certainly if the plants identified are in keeping with what industry scientists and academicians have been speaking about -- and we are, certainly, particularly at the Egg Nutrition Center since we do research and education. We're delighted to have continued emphasis in the research area as well as all that the federal government and others have provided in the decades -- not quite decades yet -- but the years have already gone by. And so I thought I'd just make a couple of comments and emphasize a few things and identify a couple of gaps. Again, it's a such a large area that I'm hoping there will be another meeting to deal with some of the scientists and researchers and whatnot to flush it out a little bit more.
But in a quick response, and simply to emphasize the need for understanding transmission, there are still things at the farm level that need to be addressed and certainly support for the concept of improving testing methods so that we could better identify a farm that's at risk of producing the contaminated eggs. We've got some information on that, but it always can be improved upon. If the new technology can be developed due to direct detection of the contaminated egg, that would be pie in the sky but certainly ideal.
And the thing that I think I would like to touch on most though is the social science research. When we deal with food-safety questions, particularly ones that are microbiological in nature, we don't tend to think about research other than microbiological research and where it ties in. But that's one of the gaps that I'm seeing is some sense of understanding about -- How should the messages be phrased? So that we have a risk communication based on consumer research and not simply somebody's opinion on what somebody ought to hear. But rather let the public health professionals identify what does the consumer as an example or the food service worker, as another example, need to know. And then get the social scientist to help us craft -- How do you get that message across? Along with completing the feed-back loop of where were we when we started, and what have we accomplished then by our educational programs?
This whole area of the social sciences as applied to food safety is not one that I've heard very much about and so there are a wealth of opportunities here so that we can see if we are being effective and accomplishing what it is that we're setting out to do. Likewise, consumer attitudes, knowledge, and practices, yes, I know that the agencies do some work to that effect, but I think that the results end up coming back that you either fry an egg completely or don't fry an egg completely. And again the specifics of what are the cultural practices and attitudes on it?
Who's cracking the raw egg into a glass of Coca-Cola for breakfast or orange juice? It's a cultural practice that's been described to us. Using that type of product as a health remedy is also a practice that we've gotten from market research. So this type of thing, I think, is a gap in our knowledge and understanding on this. Because how the consumer is preparing the food and, in more specific detail, are the eggs runny or not is, again, something that we're not knowledgeable about or understanding.
And, likewise, with food service attitudes, knowledge and practices, to what extent are the handling practices that are going on at the commercial level appropriate to the situation? And also their limitations, a better understanding of what their constraints are, relative to the things that could be recommended. I think there is always more room for detail in epidemiological study. Both the case controls and both the study of outbreak and sporadic disease are opportunities to plum for more details than we currently have on that. As I eluded to earlier on the educational ideas, if we have some more specifics, if we're using either the data that we have or developing a little bit more, it will give us more information on which to base the programs that are coming out.
And ultimately, the research information is not as effective if it's not communicated. If the data that's developed at either the private sector or the public sector isn't communicated to the rest of the world, a single presentation and an abstract at some obscure scientific conference somewhere doesn't count, the availability and the ability to access the research data that has been developed is part of all this.
And then the technology transfer that comes with it so that when we develop solutions on things get ideas, get information out, how to get it out into the field, and into practice no matter what it is that we call the field. So compliments, certainly, to everything that's been accomplished and those are just some thoughts in terms of additional things that we can go forward on.
VICTORIA LEVINE: Dr. Opitz, did you want to comment?
MIKE OPITZ: No.
VICTORIA LEVINE: Any other comments? If you look at Question 20 which I know is out of order, you can see that that's where we sort of are at the moment. So why don't we finish addressing that one. The question is: What research on SE in eggs is already under way and what additional research is needed to assist producers, packer/processors, and retailers in proper practices? We'll start with Dave.
DAVID GLAUER: Certainly we've seen a lot of different research projects or -- from Dr. Brackett -- what needs to be done. As I would look at it from the producers standpoint, certainly the areas of transmission, how do we get a colonized in a house, the use of vaccines? Where do they fall into a preventative program or into an overall flock-health management? Also I think there's a lot of data that is being generated in academic as well as departments of Agriculture's laboratories. And there is a risk assessment module out there in which a lot of this data can be put in. I think we ought to make some utilization of that risk assessment module and maybe we can help address the issues of what test samples where they should best be taken. So I think there are a lot of opportunities there.
MERYL SOSA: Meryl Sosa for FACT. First, there are four areas of research that FACT would like to recommend: Research to develop or to make more available and effective live vaccine for SE; research that compares SE contamination rates between deep-litter floor systems and cage systems; research on the issue of which breeds of layers are more susceptible to SE so that the strains that are less susceptible to SE could be used; research that determines the relationship if any between hen density in cages and the shedding of SE.
Finally, under that particular list, we heard from the CDC that they have some information from FoodNet and PHLIS and those would be sporadic cases as I understand it. And then they have other information that's based on outbreaks. And as far as the information on outbreaks, they have some knowledge of the causes of those outbreaks whereas, with the sporadic cases, they don't have any information on what those particular cases are. And so we'd like to see that type of research come out so we can learn more from that.
Second, FACT recommends the creation of a central information database. Researchers would be aided by the creation of such a database. The Plan should include a requirement that results from farms operating under Strategy I and should be forwarded to a central authority such as FDA or CDC in a format that includes as identifying information only the state in which the farm is located, but not any other identifying information.
Collection of this information would be useful in determining the actual incidence of SE in shell eggs. The only other method of surveillance relies on determining the incidence of SE in shell eggs by inference from information derived from SE outbreaks. This may not provide an accurate picture of the actual incidence of SE. Finally, this centralization of information will provide a measure of the success of the Plan by analyzing the results of the sampling protocol combined with data obtained from any trace backs that have been conducted and FoodNet.
TAD GROSS: Tad Gross, OPA. As producers, I think we're all open to suggestions and practices that are developed by the universities and FDA and whoever, but I think, more importantly, from my standpoint as a producer being in Ohio Egg Quality Assurance Program now for three years, the data that we have collected ourselves here in this state has been very beneficial to all the participating members.
We as the egg processors are sharing what's working, what's not working, and we've grown in knowledge bouncing off ideas amongst ourselves and learn to understand these things better as producers and the more we continue to educate ourselves and keep our ears open to what the University of Ohio State in our case advise us to do, has been very beneficial.
VICTORIA LEVINE: Any comments from the table?
MARY EVANS: I just wanted to say that there haven't been no -- I'm sorry. Mary Evans from CDC. It's not that there have been no case-control studies of sporadic illness done. There have been and I'm not aware of all of them offhand. One in particular was a sporadic case-control study done in the FoodNet sites, 1996 and 1997, that specifically looked at SE. And I'm not sure if this information has actually come out yet, but there were increased risks from consuming runny eggs outside of the home. There is also increased risk from consuming chicken outside the home.
So there have been studies that have been done. It's just that we haven't actually taken those studies and quantified them into a risk that we're able to apply to the total number of SE illnesses. So, that's certainly something that we're working on. Research is ongoing and it's just something we need to actually pin down.
VICTORIA LEVINE: Any other comments? Okay. The audience.
BEVERLY BYRUM: I'm Beverly Byrum. I'm from the Ohio Department of Agriculture Animal Disease Diagnostic Lab. And the topics we're talking about now, remind me a little bit of what we discussed this morning in terms of what's the correct environmental sample that we should be taking? The question that we've been facing is what's the correct number of eggs that should be collected when you're looking at an environmentally-positive house? And I would suggest that there's data that is currently available applied to research, you might say, that could be utilized to answer some of these questions.
In 1996, I think it was the FDA and the USDA got together and started to create a model in which they've collected data, a large part of it which was coming from the Pennsylvania SE pilot program with some other information as well. And they came up with a conclusion and a report called the Risk Assessment of Salmonella Enteritidis in Shell Eggs and Eggs Products. And they made some suggestions using that data.
But I think that that data and some additional data that's being generated by other states including Pennsylvania and Ohio can be applied to answer some of the questions like: Which samples should be collected? I don't think those questions have been asked utilizing that data. I would suggest that that's readily available and that we take that a step further and apply the existing information that we already have and answer some of these questions. Thank you.
VICTORIA LEVINE: Anyone else?
MIKE OPITZ: I'm coming back to management strategies that were solved in the reduction of the risk. In those suggested strategies, terms like cleaning and sanitation and rodent control -- which we know are very important -- have been mentioned. I would suggest that priority in the research should be placed on refining and defining and improving those management strategies which are on the top of the priority list.
It means measures like vaccination, sanitation, and disinfection. There are new procedures and new technologies out there which involve, also, cultural engineering and so on which need to be taken into consideration. And I think there if we get more research done in those areas which is usually involved and very expensive. But see how we could make the quickest progress, the fastest progress in improving our methods to reduce the risk.
I would urge not to spend too much time on looking for sources, for new sources, where the infection might come from and how flocks can get infected. We know an awful lot about this. The last twelve years have not passed by without research. A lot of research has been created. A lot of information is available at this time.
VICTORIA LEVINE: That was Mike Opitz. Anyone else? Then we'll move to the final question which is number 19 in the Federal Register Notice. Rewashing of shell eggs is a widespread industry practice. Are there data or research to support it? And if it is disallowed, what economic effect will it have on the shell-egg industry? Tad.
TAD GROSS: Tad Gross, OPA. I'm not exactly sure that there's much of a problem in this particular question as what some people may think. If there is, the economic outcome would probably be somewhere at 30 cents a dozen less for your product if you can't rewash it. A dirty that would go through a second time would be cleaned up. So you're making a Grade A down to a Grade C under USDA specifications. So that's somewhere near 30 to 40 cents depending on market spread there in that area.
MERYL SOSA: Meryl Sosa for FACT. We don't engage in this practice on our farms or at the processing plant that we use, so we really don't have any information that we can help with.
VICTORIA LEVINE: Dave.
DAVID GLAUER: No additional comment.
VICTORIA LEVINE: Front table? Audience? Okay. We will now turn the mike over to Lou Carson.
LOU CARSON: We're going to now go to the section where people have asked to make a general statement at the end of this meeting. We have allotted a certain amount of time. We have 16 people currently who would like to make a statement. So based on that and the amount of time, we would ask you to try to keep to three to four minutes rather than five minutes if you could. So then we can allow each person to make their statement. First on the list is Ken Looper from Cal-Maine Foods.
KEN LOOPER: My name is Ken Looper. I am vice chairman of Cal-Maine Foods which is an integrated egg operation consisting of production, processing, packing and distribution. We're located in 15 states and have about 300 hen houses and 22 egg-processing plants that are USDA inspected and have been for some time.
I'm the immediate past chairman of United Egg Producers, I'm the current chairman of the Egg Quality and Food Safety committee that is working with the food safety. And I'm very interested in the Egg Safety Action Plan and any other efforts that are designed to decrease the incidence of SE in our eggs. Enclosed with this document that I am presenting to put on the record, is twelve of the ways to improve egg quality and safety that's found in UEP's Streamlined Grading Inspection Program that I would like to have included in the record. As most of you know, UEP is a national cooperative representing approximately 80 percent of all the egg producers in the U.S. These 12 items represent our recommendation to the Food Safety Action Plan: No. 1, Quality Assurance Program based on HACCP provisions at the farm and shell-egg packing plants and enforced by USDA, AMS, or USDA/APHIS. 2. Uniformity among all egg producers and packers in addressing food safety. No. 3, A streamlined monitoring program for grading inspection and surveillance of shell-egg plants administered by USDA/AMS. No. 4, Change from continuous inspection to a continuous monitoring of performance standards program for all shell-egg plants. 5. Requirements for shell-egg refrigeration and storage and transportation. 6. Requirements regarding repackaging of shell eggs. 7. Requirements regarding the dating of shell eggs. 8. A validation testing component and incentive for using SE vaccine. 9. Uniform trace-back procedures of shell eggs. 10. Documentation, verification, and third-party validation procedures. 11. Tax-payer funding consistent with meat and poultry inspection programs that are now in existence. 12. Indemnification to producers who divert eggs from the table-egg market to pasteurization as a result of the flock being SE positive.
Those are the 12 items included in our 12 point program. I think it will be very difficult to have an effective food-safety program without an effective food-handling program. An effective food-handling program in the egg business starts with an egg-processing plant. An effective food-handling program for eggs must contain mandatory inspection of all egg-processing plants funded by the federal government, the same as all other poultry and livestock plants. The President's Food Action Plan, as I understand it, does not include contain these provisions. The President's Food Action Plan overemphasizes environmental testing at the farm and does not recognize at this time the benefits of vaccination of hens to prevent SE. The United Egg Producers Plan as has been recommended to the President's Food Safety council addresses these two important issues. The producers of eggs in the U.S. strongly recommend that our plan be adopted and we will have an effective Food Safety Program that will reach our objectives. Again, Thank you for having the opportunity to comment.
LOU CARSON: Thank you. Mr. Jay Schuman from Michael Foods.
JAY SCHUMAN: Yes. Thank you. I would just like to use my couple of minutes to revisit the issue of retail food service, food safety. I didn't weigh on that topic earlier. I just wanted to state that in the food service setting, as several people have already said, food handling plays a key part in any food safety or risk management system that we could look at. It's a very visible portion of the total SE foodborne-disease illness burden that is currently in the United States.
I would like to mention that I did hear Dr. Bob Tokes from CDC at a meeting about a month ago in Atlanta, the Watt Poultry Summit, and I was surprised to learn that I guess upwards of 90 percent of the cases are believed to be sporadic or individual cases that are not picked up in major outbreaks. I believe food service settings are where most of the outbreaks can be traced. At the food service setting, I believe the model code Michael Foods has long supported a more widespread implementation of the egg-relevant portions of the Model Food Code.
The Food Code is a very rational science-based document, and it's involving a transparent process with the Conference on Food Protection that happens every two years and is about to happen again this April. And we would just support any effort to make these provisions mandatory. And part of that, as was mentioned by one of the panelists, the Certified Food Manager Program, I think, will effectively address the overall context in which food safety issues are dealt with in a food service setting that were mentioned by one of the other speakers. So we do support codification or mandatory requirement of the egg-relevant sections of the FDA Model Food Code. That wraps it up. Thank you.
LOU CARSON: Thank you. David Farmer from Praxair Incorporated.
DAVID FARMER: Good afternoon. My name is David Farmer. I'm the marketing director at Praxair Incorporated. Praxair is global leader in industrial air products and application of those products that benefit our customers and help add value to their businesses around the world.
In response to your questions on the adequacy of the imposed components of the Risk Reduction Plan, Praxair believes that given the time-temperature sensitivity of eggs related to the growth of salmonella, the proposed plan should be more emphatic on reducing the egg as quickly as possible to inquellebrate an internal egg temperature of 45 degrees or less followed by storage and transportation and ambient air temperature of 45 degrees or less.
It is a well-accepted fact that the growth of salmonella is slow in cooler temperatures. Research documents that packaged eggs in the center of a pallet requires as long as six days to reach the ambient temperature in refrigerated storage. Rapidly reducing the internal egg temperature and maintaining it through distribution reduces the possibility for increases in salmonella population.
Praxair and North Carolina State University Scientists have jointly developed the technology to cool shell eggs with cryogenic carbon dioxide to inquellebrate an internal temperature of 40 to 45 degrees and a processing time of approximately 80 seconds. This process of rapidly cooling shell eggs before packaging is expected to cost less than seven cents per dozen. Rapid-cooling technology may be seen as an economic alternative to pasteurization processes and it may also be complimentary to pasteurization processes which may need to quickly reduce egg temperatures after high-temperature treatment.
The rapid-cooling process with carbon dioxide provides several benefits to the egg industry. These benefits include enhanced food safety, extension of the shelf life of shell eggs, and enhanced quality of shell eggs. In the food safety area, research was completed in a laboratory environment evaluating the growth of salmonella in inoculated eggs after being rapidly cooled by carbon dioxide. Inoculated eggs cooled cryogenically, actually showed reduction in the number of salmonella organisms over a 14-week storage period thereby enhancing the safety egg. Eggs that had been rapidly cooled with carbon dioxide were found to have stronger vitellin membranes which protect the eggs and prevent migration of salmonella by separating the contents of the yolk and the albumen. Strengthening the vitellin membrane could relate to a longer shelf life over time. Preliminary testing shows that shelf life could be extended from current industry practice of 30 days to 60 days. Rapidly cooled eggs also have a statistically higher haulage value than the eggs that were not cooled with carbon dioxide.
Praxair is currently in the process of commercializing the technology to rapidly cool shell eggs with carbon dioxide. A prototype egg cooler is currently being tested in a production facility for shell eggs. It is expected that the units will be available to the egg industry in the second half of this year. Thank you for your time.
LOU CARSON: Thank you. Alice Walters from Ohio Poultry Association.
ALICE WALTERS: Well, hello again. As you heard earlier, we've had a program in place in Ohio since 1996. Currently, 98 percent of our egg producers are part of the Plan. But it wasn't the Ohio Poultry association alone that developed that Plan. We had a great deal of help and hard work from partners in the plan, and that's our egg producers, the State Department of Agriculture, our State Department of Health, our Food and Drug Administration regional office, the Ohio Grocers Association, the Ohio Restaurant Association were also part of that.
And credit needs to go to Dave Glauer who sits on your panel because he has also been very proactive in a lot of the implementation of the areas that we have started here in Ohio. It's important during the process that we're undergoing today, that the federal agencies that are developing these standards and guidelines that are going to be implemented amongst the states and across the nation that we have a program in place that can pass to implement those and also takes into account what's happening in the state associations and with the state systems already in place. And, also, the producer could choose to be part of the state association or national program.
An effective guideline which we haven't talked about very much today is the National Poultry Improvement Plan Program which is in place and operating similar to this which could be used as a model for the National Egg Safety Program. In the interest of time, I brought with me and I gave to Linda out in the hall disks of the copy of our program so you could have those of the complete program here in Ohio.
Since the implementation of our shell-egg program, the Ohio Department of Health, which is one of the partners in our program, has reported that the cases of SE has dropped from 332 cases to 157 cases in Ohio, of course not all these cases are egg related. That's based upon the data that's available to us, but the 1998 FoodNet surveillance reported a 44 percent decrease in the United States from SE in eggs as you heard earlier. During 1999, this is some data I know some of you were looking for, Ohio had 1,204 manure-picked environmental samples from 223 flocks tested by the Animal Disease Diagnostic laboratory at the Ohio Department of Agriculture, they're the third-party tester in this program. The lab is an AAVLD accredited lab, one of only 36 in the nation. In 1999, 2.9 percent of our environmental samples which were from 21 flocks in Ohio were positive. And this was an environmental program, but 98 percent of the producers, once again, were part of it.
We do require a mandatory training of those individuals charged with implementing the program at the farm levels. The training includes biosecurity, management records, insect and rodent control, and manure testing. The program also requires manure -- and even egg -- testing if the manure sample is positive. The keeping of management records is required to be part of a program. And this year, we've started third-party auditing by the Ohio Department of Agriculture. They'll be going to all the farms and doing those record checks.
We meet regularly, all of us involved as partners in this program to discuss what works and what does not work. I would encourage you to have flexibility of some sort built into the program because we have found we have to be flexible. As technologies change, and as other areas change within the industry, we have to sometimes also change and add new parts to the program or delete some parts that aren't working. So I encourage some type of flexibility.
Once again, this whole set of comments will be put into the record. But for the interest of time, I'm skipping over a lot of it. You also heard this year that pullet testing will also be included in the program. Environmental samples will be taken in the pits of the pullet houses at 8 to 12 weeks of age prior to placement in the layer house. Probably the greatest cost to producers could occur if a pullet house does turn up positive. We haven't had that yet occur in Ohio and it could be costly to the producer. There are a couple of mechanisms in place as I mentioned earlier such as an SE vaccine and then further egg testing. But, once again, it could be costly especially to contract growers.
You've heard about our egg-processing plant participation and the oversight of that program lies with the Food Safety Division in the Ohio Department of Agriculture. That is required by law. It is in the Egg Quality Program, but 45 degree ambient temperature and twice a year inspections by Food Safety are required in the egg-processing plants under Ohio law. Thank you very much for allowing to present testimony today.
LOU CARSON: Thank you. Dr. Jill Snowdon, the Egg Nutrition Center.
JILL SNOWDON: Thank you. I'm going to confine my comments to two topic areas. And to no great surprise they will reflect and repeat some of the things I've already said earlier in the day. The first subject is that of training, the need to make sure we are taking the information that we have and getting it out where it needs to be so that when we think about training. I've got four categories. We think about industry training, technology transfer on control techniques.
This is an opportunity that we have to take the information that we know from the years of research and get it implemented. Some of that is needed to help and support individuals that may want more knowledge about things, rodent control, the effectiveness of vaccines, whatever the technologies or processing technologies that might help. Another category of training is certainly the consumer area, the concept of a consumer using a fresh, intact, cool egg that they cook completely. Training in terms of cooking for large groups.
What does it mean as a volunteer food service operator when you're working either for a large family gathering or with an organization that you're working for and then preparing food for large masses? We get outbreaks associated with that kind of thing on a regular basis.
The importance of cleaning or choices, in the dietary choices, what recipes might be a little more risky than others, what are the options and alternatives on that kind of thing? And food service, certainly training comes into play there time and time again. The concept of pooling. And even if we start with pasteurized product for pool product, then you're taking another product and combining it with that which is perhaps contaminated. So starting with pasteurized product may not be adequate. But all of these details, the cross-contamination, the inadequate cooking --
The fourth category under training is training of those who tend to serve the vulnerable population. We might want to be thinking of that as a completely separate category whether we're talking about the aged, the ill, or the young.
And the second category on comments is what I'm calling low technology control options that in some instances I think that we can use simple solutions to complex problems or at least not overlook them. And I'll give a couple of examples of what I'm talking about on that, and this is to amplify and support all the other alternatives that we have, other options for control techniques including the technologies that are available or the new technologies that might be developed.
But one example is the use of pasteurized liquid product. We already have pasteurized liquid product that's available and the food service industry is using it. And so there is an option that we have that doesn't take time or money to access, but maybe it's a change in attitude, advertizing, marketing, education, or some such thing like that. If we knew maybe more about consumer preferences or if we knew what would stimulate the use of that type of thing --
Again, it's a low cost, low technology option here that's going to amplify alternatives in this situation. Another low technology technique is the communications and technology transfer and the social science studies that I've been talking about earlier. They may be kind of obscure to us, and they may be sophisticated in terms of social science, but they're not extraordinarily expensive or hard to implement. The studies, getting the actual results out there, might be a little more difficult. Vector control is another example, but that again is a technique that is not terribly sophisticated but can be a gap that can continue to be addressed on this.
Another example would be the small and backyard producer that the program, as it's currently designed, is only addressing the large commercial operations. And so if the role of the program is to eliminate disease associated with eggs, then there is a gap here and that is with the small and backyard producer. We're talking about millions of eggs. You've got thousands of backyard producers across the nation. A handful, again, more of those who may be producing with small flocks for the localized areas, for niche markets, specialized markets, that may be on the increase in some instances.
This is going to represent millions of eggs. Any one hen -- let's say if somebody has a flock of ten birds, you know, that's going to be thousands of eggs coming out in the course of the year just from that flock alone. So we're talking about thousands of illnesses here, but we're also talking about millions of eggs that aren't included in this kind of program.
And so from a public viewpoint, I have to wonder is it just the large commercial production we're concerned about or is this a gap that we want to address on that.
And then forced-air cooling is another example of a low technology technique that in some instances punching holes in the sides of boxes and putting fans and cooling units and things of that nature. California is the one that did the study on that. But that's an example of a low technological approach that would amplify the chilling of the product. It's based on the chilling that's done with fresh fruits and vegetables, that forced-air cooling type of thing.
So I'm simply encouraging us to think of the basics as well as the sophisticated as we move forward on all of the plans that we have going on. Thank you very much.
LOU CARSON: Thank you. Ms. Ritchie Laymon, United Poultry Concerns.
RITCHIE LAYMON: Yes. I'd like to thank FSIS for making this a public forum. I think it's very important that everyone in the community get a chance to speak. I was very pleased to see that in the research portion that you do have forced molting on the list of things to be studied. Starving livestock to increase production is not only barbaric, but I think it's unsafe and I hope it will be outlawed at some point. And I have two fact sheets I'd like to enter into the record. Thank you.
LOU CARSON: Thank you. Tom Hertzfeld, Hertzfeld Poultry Farms Incorporated.
TOM HERTZFELD: Tom Hertzfeld, Jr., vice president of Hertzfeld Poultry Farms near Toledo, Ohio. Our farm has over 1,400 acres and 900 layers. These have been operated by our family since the 1930s and employs 100 employees with 18 of those being family members. We market our eggs in Ohio, Michigan, and the East Coast from our USDA-graded egg- processing plant. We have two contract growers and the rest of our layers are company-owned birds. There also is a separate grain mill. We have been a participant in the Egg Quality Assurance Program since it started in 1996.
The Ohio Egg Quality Assurance Program has helped us to look at the management of our operation in such areas as egg quality and HACCP issues. Rodent control has much more emphasis than it did before being on the program and our participation has made us more knowledgeable in the area of food safety and biosecurity.
I want to commend the Egg Safety Action Plan for bringing this meeting to Ohio and my recommendations will be based upon what we as egg producers know already works because of Ohio's Egg Quality Plan. You have heard Alice Walters the Executive Director of the Ohio Poultry Association comment on Ohio's plan, and I would like to follow-up on some other areas that should be emphasized on the federal level.
All of the egg-processing plants in Ohio are part of the Ohio Egg Quality Assurance Program and Inspected by Ohio Food Safety laws. Our laws in Ohio also require that all eggs be refrigerated at 45 degrees ambient temperature from farm-to-table this law has been in place since the early '70s and it is enforced by the Ohio Department of Agriculture Division of Food Safety. Most of our processors also have USDA egg-grading services. So effective HACCP programs are required.
However, under food safety laws in Ohio, all Ohio egg-processing plants are inspected twice a year, and the critical control points and HACCP plans that have been established are monitored. There is also a policy letter issued by the ODA to all our egg processors that prohibit repackaging by retail food markets and excludes the retailer from returning eggs to the processor for repackaging. The only time that the eggs are allowed to be reprocessed and repackaged is if the USDA grader finds dirt in the lot at the egg-processing plant. Therefore, it is important that there is an indemnification plan built into the program.
Most of our egg-processing plants also have flat washers for plastic flats. Processors are encouraged to wash pallets and flats to return to the grower to reduce the possibility of contamination.
Since a level playing field is necessary to prevent unfair marketplace competition, the federal government should oversee the program in those cases where state departments of agriculture have the capability and willingness to participate. The day-to-day implementation of a program should be left to the state as is true with the National Poultry Improvement Plan Program.
Ohio's program is effective only because we have worked jointly with the Ohio Poultry Association and various state agencies like the Ohio Department of Agriculture, Health Department, and the FDA regional office, in its development.
As for additional labeling of egg cartons, unless it is a seal for this program similar to the egg pasteurization seal, it is impractical because wording, for one, will not fit on the cartons.
I would call upon the FDA to spearhead initiative to help egg producers on this program to be able to establish a price floor for their table eggs. This would allow them to cover the increased costs of being on an egg safety program. Otherwise, only larger egg producers can compete because of the greater flexibility to spread costs in a larger operation. Egg prices have not increased dramatically in the last 20 years while inputs to egg producers involved in HACCP implementation have risen in cost.
In Ohio, all of the water used in our processing plant is required to be monitored by our local health department and EPA twice a year. The test results are submitted to USDA. The layer houses are also tested twice a year for iron, choliform, ect. Our state also encourages farmers and rural residents to have their water wells to have tests conducted. So I do not believe additional federal oversight is needed in this area.
Additional research is needed as a cost-effective strategy for producers to produce SE. The mechanism whereby SE is transmitted also needs to be defined. Reliable rapid detection kits would also be extremely helpful. We know that a trace back of SE to a farm has severe economic consequences for that producer. In fact, oftentimes, it seems as if the producer stands alone burdened with all the risk even if the product was mishandled and contaminated by humans with SE at another level of preparation. Safeguards against food mishandling or contamination must be incorporated for the producer. When the producer already incurs the cost associated with an effective egg HACCP Program, it is unfair if mishandling it at another level causes blame not to mention all the negative media coverage to be laid on his or her farm doorstep. I've mentioned that a C&D of a positive barn can be anywhere from $4,000 to $8,000. In surveying our producers in preparation for this public meeting, we have been able to determine costs associated with implementing an egg safety standard. Many of our farms in Ohio have personnel totally dedicated to implementing our egg quality assurance program.
There are employees for rodent and pest control, quality control, biosecurity, paperwork and documentation. Our research indicates that the cost for an egg quality assurance program is $60,000 per year per million birds annually, which does not include the economic losses for the possible devaluation for diverted eggs. USDA grading costs another $100,000 per million birds annually. To upgrade refrigeration could be a one-time expenditure of $100,000. This is why it is important that whenever a new program is developed, we check the cost consequences for small, medium, and large producers.
In fact, we have contract growers in Ohio concerned about the consequences for them if the pullets they are growing come up positive or if the contract layer house come up positive. To date, contract holders have been willing to help contract holders absorb C&D costs. But this may not be true in other states. That is all the more reason for the establishment of either a fund to indemnify or an egg price floor for participants. If you wish to protect the family farmer, then this area must be seriously considered.
Thank you for allowing me to present testimony today. I hope that the comments from those of us who are already participating in a program in Ohio will be helpful in planning a federal program.
LOU CARSON: Thank you. Phil Debok, the Pennsylvania Department of Agriculture.
PHIL DEBOK: I'm making this statement on behalf of the Department of Agriculture and the Pennsylvania Egg Industry. Unfortunately, it was written based on the plan as we reviewed it, and we didn't have the benefit of some of the information that's been put out at the meeting today. Pennsylvania received this draft notice very early in the SE war. Our egg industry answered this call to arms willingly and at great expense.
Based on this considerable experience, we do feel that shell-egg safety could best be managed through voluntary cooperative federal, state, and industry programs as evidenced by the success of the National Poultry Improvement Program, our own Egg Quality Assurance Program, other states quality assurance programs, and corporate programs as described by the representatives from Michael Foods and Nest Eggs.
Voluntary programs have the disadvantage of perhaps taking a little bit longer, but that's probably offset by industry buy-in and ultimate savings to the taxpayer. That said, however, we will support the National Egg Safety Plan and it's mandated approach to egg safety. We do this with full realization to the significant expense that will be borne by all parties, federal, state, industry, and the taxpaying consumer.
However, there are several portions of the Plan with which we have concerns. Number one, priorities for research. Objective 7 of the Action Plan focuses on adequate current information that is available to make decisions about SE preventive controls, surveillance and education based on sound science. With that purpose stated, the timeline for research then proceeds to have pasteurization listed as an action to be completed ahead of intervention strategies, on-farm testing, and even ecology and epidemiology of the SE organism. Now, that may be a misinterpretation on our part, but in our opinion, the research on ecology and epidemiology of SE in the chicken and on the farm, should be the top priority for the research guidelines.
Specifically, we need to determine why, even with applications of known best-management practices, are we unable to eliminate infection in some houses or complexes and what can be done to more effectively decontaminate a premises. We also need cheaper, more sensitive, and rapid tests with which to validate the effectiveness of our program.
Warning labels, you maybe didn't want this discussed at this venue, but this is something that the industry in our state feels strongly about. In the scope section of the Action Plan, it mentions a proposed rule that would require a safe-handling statement on the package. Objective 8 of the Action Plan, Section 8.3.3 adds warning labels as a part of the statements required on those packages. This is an area of concern to us. We support safe-handling instructions and refrigeration labeling for all eggs produced and marketed in the United States. Our concern is with the specific wording of the warning label that is mentioned in 8.3.3, the July 1st, 1999 press statement from USDA which states the proposed handling instructions will include the following statement: Safe- handling instructions, eggs may contain harmful bacteria known to cause serious illness, especially in children, the elderly and persons with weakened immune systems. For your protection, keep eggs refrigerated, cook eggs until yolks are firm and cook foods containing eggs thoroughly.
The first part of this label is not a safe- handling statement. It is an overly aggressive warning that alarms consumers who may very well interpret it as these eggs may kill my child or grandparent and I better not even open the carton or someone may get sick.
To require an industry to undergo intense monitoring, implement certain production management practices, and then at the same time tell their customers that the product may be unsafe seems counter productive to us. Our recommendation is to include a true safe handling instruction statement on all cartons of eggs that says, keep refrigerated at all times, cook eggs until yolks are firm, and cook foods containing eggs thoroughly. This is a simple statement that consumers will understand and that will accomplish our objectives. Funding for implementation at the state level. Testing, monitoring and education programs are very expensive and many states may be unable to adequately fund an effective program. Since this is being proposed as a nationally mandated food safety plan, we would encourage the federal government to provide funding proportional to the size of the egg industry in each state for states to implement the Action Plan.
Also, when developing standards, please remember that at least on the state level this program will be in competition with a number of other quality assurance programs such as a Units Disease Program, Dairy Quality Assurance Program and others that are all rely very heavily on microbiological testing.
We need to tailor the Egg Safety testing program to get the maximum effect with the minimum testing. In other words, if we can address 80 or 90 percent of the problem with "X" number of dollars, let's think long and hard before we commit to spending three or four "X" dollars to attack the other five or ten percent of the problem.
That concludes my comments. Thank you.
LOU CARSON: Thank you. Beverly Byrum, Animal Disease Diagnostic lab. Darren Mitchell, Center for the Science in the Public Interest.
DARREN MITCHELL: I thank you. I will keep my remarks pretty brief. I thank you for the opportunity to sit at the table and comment on other aspects of the Plan. CSPI believes that the Egg Safety Action Plan is a giant step forward compared to what we have today. And we commend and applaud those of you who have worked very hard on it. As we said before, it's a long time coming, but we are very pleased that the overall strategy, the two-pronged strategy we think will really improve egg safety.
However, our concern is that what looks good on paper may not bear fruit in practice based on the fact that the Plan doesn't, in our view, adequately address the highly fragmented federal program. And we think that a single independent safety agency dedicated to egg safety is necessary and what we need really is consolidation, not more attempts at cooperation and coordination.
Just one more brief point. I wasn't going to mention labeling, but since the last speaker did, I'd like to say our position on the labeling issue is that the language -- we don't completely agree with the current language. We think it may be a little lengthy. We believe strongly that there needs to be a tie-in on the instructions to handle eggs safely due to the hazard. I think FDA research has shown that that's necessary and that's something that we believe in very strongly.
We do, however, for those states and programs that are currently using quality assurance programs that have seemed to work, think there's room for sort of a two-tier system until there's a mandatory uniform national standard where perhaps people with PEQAP-type programs that have those kinds of standards could use a label that is less harsh. And ultimately, as the program is used on a national level, and data shows that it's being effective, we can revisit the labeling issue and see if different language makes sense. That's it. Thank you again.
LOU CARSON: Danny Hughes, Arkansas Livestock and Poultry Commission.
DANNY HUGHES: I am employed with Arkansas Livestock and Poultry Commission, however, my statements this afternoon represent the National Egg Regulatory Officials. We're a group of member states which now consists of the majority of the states across the nation made up primarily of program managers and program directors. We got together back in '92 to try to get the states more uniform with their state egg-marketing laws. We have made some headway towards that. Our meeting and annual work that we do is getting better each year.
Due to the food safety issues, we've become more involved with the federal agencies, both the FDA, FSIS, AMS, and when all of our states working as hard as we have, many of us for 30 years involved in our egg state laws because of the absence of federal regulations, the states have developed their own programs for the egg safety based on the regional risk, industry practices, funding, and our legislative support. Because of this, this has created a lot of variations in our programs and in enforcement across the country.
A mandatory program with funding provided at the federal level will eliminate these variations. USDA and FDA have successfully used contracts and cooperative agreements with states for many federal programs; example, the sea food and animal disease monitoring for APHIS, poultry and egg volunteer grading programs, and the surveillance for the Egg Products Inspection Act.
Many of our states have been involved in both the grading and Egg Products Inspection Act for 25-30 years. The majority of the inspections under the surveillance program with AMS is conducted by state employees. These employees are licensed by USDA and follow inspection guidelines issued by USDA. This program has been very successful. The state employees are highly qualified and their use is very cost effective. The program has been uniformly enforced throughout the country.
For these reasons, we believe the use of contracts with states would be extremely effective. Because of the experience of the state people and the majority of them who are involved in both grading and surveillance, we have probably got more years of hands-on experience in shell-egg processing plants and the surveillance program than all the federal agencies put together. And for those reasons, our integrity has been proven and I think that would be backed up by the federal agencies which we've had partnerships with. There again, we would very much like for not only FDA but FSIS to consider the state departments of agriculture when it comes to the enforcement of distribution at the retail level and in the plant. I appreciate you for your time.
LOU CARSON: Thank you very much. Meryl Sosa from FACT.
MERYL SOSA: Before I get into my final additional comments, I did want to ask one question to FSIS, FDA which is a bookkeeping requirement -- when are the written comments due?
LOU CARSON: The written comments are due by April 20th to either docket.
MERYL SOSA: Again, we'd like to thank the USDA and the FDA for asking us to participate in the meeting. It is our hope that the USDA and the FDA will use the Egg Safety Action Plan to develop a comprehensive, mandatory federal program with uniform standards designed to eliminate the threat of SE in shell eggs.
Earlier, we discussed the issue of the 120 inspectors currently used to inspect a processing facility. We believe that in a single egg agency, the head of the agency would recognize that using 120 inspectors to inspect the safest area of the shell-egg continuum is a tremendous waste of resources. It would redeploy such funds and employees to other areas of the continuum such as on-farm where they would be better utilized. Under the current version of the Plan, FSIS will continue in it's role and the Plan does not provide for a position with responsibility for oversight of the entire continuum. Thus, it may be assumed that this type of anomaly will continue. By continuing the division of responsibility between three departments of two agencies, many of the same deficiencies existing in the current system will continue. First, confusion on the part of producers and consumers will continue. For example, the Plan merely states that "FDA" will develop standards for egg producers that the states and the FDA will enforce.
However, the Plan does not disclose which department or departments within FDA will perform these functions. Second, nothing within the Plan addresses the issue of conflicting mandates within the same agency. For example, part of the USDA's purpose is to both promote egg sales and to regulate portions of the egg industry. When the USDA permits producers to affix the USDA Grade A stamp on egg cartons, which mandate is being fulfilled?
The consumers may believe that the stamp certifies that they are purchasing a safe product. In fact, the stamp is a promotional tool signifying that the egg meets certain quality standards, not food safety criteria. The USDA regulation regarding stamp does not include any provision for the prevention of SE. In the final analysis, the juxtaposition of these two purposes within one agency conceivably places the interests of the food industry over and against the food safety needs of consumers. Nothing in the plan addresses this source of confusion to producers and consumers as well as the possible conflicting mandates.
Fourth, FACT disagrees with the use of AMS as the agency for enforcement of performance standards for packers and egg-products processors. AMS is an inappropriate choice. AMS is only role with regard to eggs to date has been to assist in the marketing of eggs by ensuring that eggs from those producers participating in the USDA grading program meet USDA's quality standards. Of course, it should be noted that only one-third of egg producers participate in the voluntary AMS egg-grading program. Thus, AMS does not have the expertise to support an egg-safety department.
Fifth, the Plan leaves enforcement of on-farm regulations to the FDA and the state. This is not a viable option as allows for variation among the states since states have different priorities and fiscal abilities. For example, some states may not place a high priority on egg safety and, therefore, will not allocate sufficient funds towards enforcement of egg-safety regulations. This may lead, as it has with hog-concentrated, animal-feeding, operations to egg producers making their citing decisions based on the strength of a state's egg-safety enforcement program. This should not be permitted.
In conclusion, FACT believes there should be a single egg-safety agency with responsibility for the entire farm-to-table continuum. Absent a single agency at a minimum, there must be put in place a method for effective coordination among the agencies in order to avoid duplication of efforts, allow for clear roles and responsibilities, and to ensure the efficient and effective enforcement of regulations regarding egg safety. Thank you.
LOU CARSON: Thank you. David Stein, Indiana State Egg Board.
DAVID STEIN: Thank you. I have no statement.
LOU CARSON: Richard Dutton, Michael Foods.
RICHARD DUTTON: I'd just like to reaffirm some of the comments that have been made. Actually, we would reaffirm that the pullet-testing program as stated is essential. Reaffirm also that NPI Programs have been effective and support their continued use. Also that vaccination is an essential part of a program, that without it there will not be success. Also that sanitation is short term in effectiveness although temporarily effective. Multiple testing of houses is essential. One test will not be effective in reducing the problem. We would encourage the use of certified laboratories and for testing of samples. Also, support the third-party verification programs preferably with one coordinator at least. Also that uniform requirements across all producers and all states are essential, and then bring up a couple of questions. One is in my travels and in talking with producers and so forth. There is still very much a concern about privacy of test results and safety of the individual producers. And if something in the program could be developed to ensure their safety, their privacy at least. Also, that purchased eggs -- have run across this a couple of times -- in either that ECI or purchased eggs are not required to have label or to be under program that I am aware of anyway. And also, a clarification as to who is required to be with the program and what size farm? That needs to be clarified. Thank you.
LOU CARSON: Thank you. Kenneth Anderson.
KENNETH ANDERSON: I'm Kenneth Anderson, North Carolina State University. There was a topic brought up at the beginning of this session indicating that we need to evaluate husbandry practices -- I think Mike Opitz brought that up -- to reduce and get the best management practices in play that would eliminate or reduce the salmonella incidence in layer flocks.
I think this is a poor forum for people to push the agenda of animal rights, and molting of layers is an animal rights issue. As an individual with many of years of experience in animal behavior as well as physiology knows, it is not an inhumane practice if it is done correctly. That does not mean that it is not stressful. That's the whole idea of it. But it does extend the productive life of the flock and as the other research from Bob Eckroade and others have shown, there is no real relationship between that practice and increased incidence of salmonella-positive environments.
So I think this is a poor venue for that and I think we need to look at it as a husbandry practice, evaluate it, just like we need to do all husbandry practices and get the best management practices in to reduce the problem as we see it as a problem in the reduction of salmonella in eggs. Thank you.
LOU CARSON: Tim Davis, Fort Dodge Animal Health.
TIM DAVIS: Hi, I'm Tim Davis with Fort Dodge Animal Health. We are a manufacturer of salmonella vaccine. I'd like to thank you for the opportunity to speak. We've heard vaccination mentioned several times today. I'd just like to make a few comments concerning vaccination.
My comments aren't necessarily to push for additional steps in the President's Plan, but instead to be considered as alternatives to the President's. I'd just like to say what vaccination does. Vaccination reduces the colonization of SE in the gut and in the reproductive tract of a bird. Vaccination offers the bird a line of defense the day of exposure which could potentially occur the day after testing.
The second thing that vaccination offers that has been talked about quite a bit less is the line of defense that it offers in the egg. Dr. Peter Holt at the University of Georgia has done quite a bit of work that demonstrates that antibodies in the egg from salmonella vaccinated chickens actually offer a line of defense to salmonella. It actually inhibits the growth greatly of salmonella enteritidis in eggs.
I don't have the numbers, but I think it's something like when he did a side-to-side experiment of vaccinated eggs and non-vaccinated eggs, I should say, eggs from vaccinated hens and non-vaccinated hens, that there was a difference of a 10 to the 2 and 10 to the 8 salmonella populations in the eggs. So it's very significant.
An egg antibody could be a line of defense in eggs that are mishandled in the marketplace. Antibodies in the egg could be beneficial in situations such as pooling of eggs and nursing homes and other at-risk consumer groups. Dr. Holt has done some small studies that need to be looked at further where he's actually taken an egg with antibodies from a hen and pooled it with eggs from hens that were not vaccinated and he actually saw some reduction in salmonella growth when comparing it to eggs that were completely without antibodies. So I just wanted to bring those points up and thank you for your time.
LOU CARSON: Thank you. That is the last person who is registered to speak. Does anyone else wish to make a statement at this time? Thank you. We are going to then move to closing remarks. Judy.
JUDY RIGGINS: I'm just going to speak from where I'm sitting. First of all, we really thank you for your active participation this afternoon. One of the important things for us as regulatory agencies is to gather an accurate record upon which to make our decisions in doing our proposals and going forward. And so this has really been a very productive meeting. And we hope that we have shared as much of our thinking with you as we could at this point having not thought through all of the complexities of the issues, but we thank you for your thoughts, your ideas because it will form the basis for our being able to make some informed decisions going forward.
Some of the things we've heard you say this afternoon that we are going to take serious consideration of, and have a very thoughtful approach to, in our proposal based on the information you've given us are, first of all, benchmarks. We heard loudly and clearly that we need to have a very clearly defined benchmark and to have adequate information upon which to base those benchmarks, so we know where we're starting and we know what our goals are.
Secondly, indemnification. That's clearly an issue that's important to the industry. We know that currently the only agency within the sister agencies that are working on this is APHIS. APHIS currently has indemnification, however, we will have to explore what the opportunities might be for legislative change in the event that we can build an adequate record of costs that would be incurred.
But, I just wanted to mention that none of the agencies, FDA, FSIS -- I don't think AMS currently has indemnification -- so APHIS at this point -- and that's for animal health disease issues -- And so, we will explore that. We know that we would have to have legislative change.
Then we heard clearly your concerns about testing and diversion measures. And we're going to have to seriously think how we will approach that issue in our rulemaking. Animal management practices, especially molting, is important and we will take into account all that you said, and I know that there has been numerous concerns expressed about molting and the stress factor and how that contributes to SE illnesses.
Environmental testing, how to approach environmental testing and the importance of understanding what the public health benefit is that can be gained by environmental testing and comparing that to the costs that would be incurred by the industry. We hear that very clearly in your comments.
The other issue of verification versus testing and diversion and making sure we, in our rulemaking, clearly define those and make a distinction between verification activities and testing and diversion actions that we might propose.
Vaccination is, of course, another area that we've heard many, many comments about today. And we will take that into consideration where new technologies such as vaccination and rapid cooling -- where they can be used on an ongoing basis and to make sure that we provide flexibility so that any new technology that emerges can rapidly be incorporated into practices by company.
And then we heard the concern about focusing our efforts on those areas that we know that we may gain the best bang for the buck, I guess is a way to say that. There was a discussion about the fact that there's data that shows 15 percent of the houses that are currently positive, that we might consider allocating our resources on that problem area in order to achieve the best bang for the buck and the best public health buck that is.
Then we heard about resource allocation and the disparity that currently exists in the allocation of federal resources with respect to inspection. But there is a heavy allocation of resources in the processing plants and not enough allocation of resources at high-risk facilities such as packing and on-farm. So we understand your concerns regarding allocation. We will work with the food safety initiative to redefine those priorities and to hopefully gain more resources where they are needed.
And then the last area was food service training. We heard very clearly that we need to emphasize and we need to increase the training that we are getting from food service handlers. They are a very critical point in the continuum from farm-to-table whereby contamination may occur. And we know that we need to emphasize and to build upon what we started, but to strengthen our training programs for food service handlers. Lou.
LOU CARSON: Thank you Judy. Just a few more comments. I want to echo what Judy has said. I think this has been an excellent exchange of ideas and all of the comments have been very constructive today. I want to thank you very much. Not to dwell on the same points that Judy did, but to pick up on a few others that I thought I heard.
I heard clearly that we need to clearly define roles and responsibilities especially in the area of enforcement. We need to also take into account something that's not in the Plan and that's regrading of eggs and its impact on SE illnesses. We also need to take a focus with the Plan that really does identify the positive flocks and deal with those appropriately and where there are no positive flocks, then to take appropriate actions there as well.
We need to look for long-term solutions and not simply try to solve the problem at hand, but to see how we can best assimilate those into the best practices. It's been pretty clear, I think across the board that with clear responsibilities -- what people have been asking about is strong leadership and making sure that what we craft here in our proposed rules -- taking into account the advances that the state programs along with the industry have made to date and to provide a strong leadership to make sure that moves forward.
And lastly, I think, it's been pretty clear that we do want to have nationwide consistent standards that everyone has the same benchmark, as Judy mentioned, we have the same benchmark and the same goals that we're all trying to achieve. It's been pretty clear that everyone in the room, while you may be in the poultry or egg business has public health right behind whatever your primary duty is. And that was very reassuring and refreshing to hear. So from FDA's standpoint, I really want to thank you for your time today.
Okay. Are there any other comments? Then we thank you very much. (Meeting ends 4:15 P.M.)