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Domestic Outreach Public Meetings - Egg Safety: Proposed Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production- November 2004

 

November 9, 2004

[Transcript Prepared from a Tape Recording]

  1. Welcome and Introduction
    Louis Carson, Deputy Director, Food Safety and Security Staff, FDA/CFSAN
  2. Opening Remarks [Pre-Taped]
    Dr. Lester Crawford, Acting Commissioner, Food and Drug Administration
  3. Overview of Public Meeting
    Louis Carson, FDA/CFSAN
  4. CDC SE Human Illness/Outbreak Presentation
    Dr. Christopher Braden, Medical Epidemiologist, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention
  5. Presentation of FDA's Proposed Rule
    Nancy Bufano, Office of Plant and Dairy Foods, Division of Dairy and Egg Safety, FDA/CFSAN
  6. FDA and CDC Panel: Stakeholders' Questions and Answers
    1. Todd Macklin, Cargill[ph]
    2. Richard Wood, Food and Animals Concerns Trust [FACT]
    3. Duffy Cox, National Pasteurized Eggs
    4. Larry McBee, Rose Acre Farms
    5. Ken Colcabick[ph], University of Illinois
    6. Jim Gillum, Henrickson Foods
    7. Bob Crouse, Midwest Poultry Services, Indiana
    8. Howard Magwire, United Egg Producers
    9. Rich Dutton, Michael Foods
    10. Pat Stronger, Dayvek[ph] Foods, Lake Mills, Wisconsin
    11. Dave Thompson, Pearl Valley Eggs
  7. Stakeholders' Public Statements
    1. Greg Murch, Senior Vice President, Sparbo Company
    2. Robert Crouse, Midwest Poultry Services
    3. Richard Wood, Executive Director, FACT
    4. Dr. Richard Dutton, Michael Foods
    5. Todd Macklin, United Foods
    6. Dave Thompson, Illinois Egg Producers
    7. Pat Stronger, DayReg[ph] Foods
  8. Closing Remarks/Adjournment
    Louis Carson, FDA

Proceedings

 

[Welcome and Introduction]

DEPUTY DIRECTOR CARSON: [In progress] In addition to the people I mentioned, Dr. Bradley Brown, who is an economist, again, within our Center for Safety and Applied Nutrition will be here. We will try to answer your questions to clarify any parts of the rule you may wish to ask about.

Following that, we will have a break and then following the break, we will invite you to provide public comment.

As of right now, I have four people who have requested public comment, but you all have an opportunity, even if you have not registered ahead of time. So, let me just tell you who I have so far and after those people have their opportunity to speak, I'll open it up for additional public comment.

Dr. Richard Dutton, from Michael Foods, Robert Crouse, from Midwest Poultry Services, John Mueller, Sparbo Company and Richard Wood, from FACT, those are the ones who have requested to speak today. Again, after those four have their opportunity, we will open it up for additional public comment.

So, let me first make a few public comments and then we will turn it over to the tape of Dr. Crawford.

Again, FDA proposed our rule on September 22nd. It is open for a 90-day comment period, which closes on December 21st. As I mentioned, this is the second of three public meetings. Our last public meeting will be held on November 16th in Los Angeles, California.

In this proposed rule, FDA is announcing a program that would require egg safety measures to prevent the contamination of shell eggs with Salmonella Enteritidis during egg production. This is one step of a broader farm-to-table egg safety program that includes labeling and refrigeration rules, which we published in 2000 and went into effect in the year 2001.

As Dr. Braden will tell you in his presentation, we are basing this and our public health goals of reducing by 50 percent Salmonella Enteriditis illnesses and deaths by the year 2010 on the statistics and the data that CDC does generate in their surveillance programs.

So, what we are proposing today is an on-farm prevention program measure. We also have requested comment on additional measures within the proposed rule. We would invite you to submit your comments to the dockets on the entirety of our proposed rule.

With that, I would like to now sort of cue up our presentation from our Acting Commissioner, Dr. Lester Crawford.

[Pause]

 

[Opening Remarks]

COMMISSIONER CRAWFORD: First, let me thank you for that kind introduction.

It's a pleasure for me to be with you this morning to kick off FDA's first public meeting on our proposed rule for preventing Salmonella Enteritidis in shell eggs. Obtaining stakeholder input is an important part of FDA's rulemaking process.

It's estimated that there are about 118,000 food-borne illnesses per year caused by consumption of SE-contaminated eggs. You will hear more detail on the incidence of SE human illnesses from our CDC colleagues on the program.

If you were to eat an SE-contaminated egg that wasn't fully cooked, you could suffer symptoms ranging from mild to severe gastroentestinal illness, short term or chronic arthritis and even death. We believe that FDA's proposed rule on the prevention of SE in shell eggs during production, when implemented in egg production facilities, will significantly reduce the number of illnesses caused by SE-contaminated eggs. In fact, according to our estimates, the implementation of the provisions of this proposed rule would reduce the number of SE-related illnesses by 33,500, which would be a major step toward our public health goal of a 50 percent reduction in all Salmonellosis and a 50 percent reduction in SE outbreaks by 2010.

The proposed rule that we are seeking your input on today, builds on our earlier safe consumer handling, labeling and egg refrigeration and retail rule published in 2000. Our motivation in proposing this new rule is based on a farm-to-table risk assessment of SE in eggs that identified implementation of on-farm prevention measures as a very important step that could reduce the occurrence of SE infections from eggs.

FDA realizes that voluntary quality assurance programs in the egg production industry have led to meaningful reductions in SE illnesses, but these programs are not always uniformly administered or uniformly comprehensive in their prevention measures.

Let me emphasize that, this rule would apply to all egg producers with 3,000 or more laying hens that produce shell eggs for retail sale and do not process their eggs with a treatment, such as, pasteurization to insure their safety. This rule would not apply to producers who sell all of their eggs directly to consumers or producers with fewer than 3,000 laying hens.

If a producer has 3,000 or more laying hens and all eggs at the farm are given a treatment that will achieve a five-log destruction of SE or are processed into egg products, then only the proposed refrigeration requirements would apply.

Some of the major production areas that we addressed in this proposed rule and which you will hear about in detail from our CFSAN representatives include procurement of chicks and pullets, bio-security, pest and rodent control, cleaning and disinfection of poultry houses and refrigerated storage of eggs on the farm.

We know that there will be a substantial cost to producers to implement this rule. In fact, we estimate implementation will cost $82 million annually for the more than 4,100 farms that have 3,000 or more hens. But it will prevent an estimated 33,450 illnesses due to SE annually, at a cost of $2,450 per illness, for a total annual benefit of 580 million, resulting in $498,000,000 in net benefit annually.

So, we at FDA believe this rule will provide significant public health benefit. FDA appreciates your participation and input into our rulemaking efforts on this important issue and I wish you a successful meeting.

Thank you.

[Pause]

 

[Overview of Public Meeting]

DEPUTY DIRECTOR CARSON: Okay, again, I want to emphasize our program today is to first present to you the surveillance data and how CDC arrived at our baseline number of 118,000 SE illnesses per year and Dr. Chris Braden will be doing that first. Following him will be Nancy Bufano, again, presenting the proposed rule in its entirety and, again, following that, we will have a panel session to answer any clarifying questions.

So, first, I would like to call on Dr. Chris Braden.

[Pause]

 

[CDC SE Human Illness/Outbreak Presentation]

DR. BRADEN: Good morning.

Can you hear me okay? Is this mic working? Okay.

As said, I am from the Centers for Disease Control. We conduct surveillance for a large number of diseases and illnesses, including Salmonellosis and specifically for Salmonella Enteritidis. I want to just go over a couple of terms I will be using. I'm sure you all are familiar with them. Just so that we are on the same page, however, I will go over them.

Salmonella Enteritidis is a bacteria. Salmonella Enterica, that is the genus and species name with the serotype Enteritidis and throughout, I may be referring to it as SE. A serotype is a subcategory of Salmonella, based on reaction with specific antibodies. Salmonellosis is the disease caused by infection with Salmonella Enterica. I will be talking about isolates, which are Salmonella bacterium obtained from a single laboratory culture.

Now, we have a couple of different types of surveillance for Salmonella. One is a surveillance for individual cases. Salmonellosis is a nationally notifiable disease, as defined by the Council for State and Territorial Epidemiologists and CDC. States have laws which require case reports from laboratories that isolate Salmonella or physicians who diagnose it. The states voluntarily report those cases to CDC.

Secondly, we have surveillance for food-borne outbreaks. An outbreak is defined as two or more people ill due to a common food exposure. Outbreaks may be reported to health departments, local health departments by people who are ill and call in or, perhaps more often, they are recognized by the health departments themselves. As a part of their surveillance, they recognize that there is an increase in the number or some other characteristic of cases that would lead them to believe that an outbreak is occurring.

After outbreaks are identified and investigated, those outbreaks are then reported to CDC in an aggregate report, saying that there are so many ill due to such-and-such a food, due to Salmonella, et cetera.

Now first, I'm going to talk about the case surveillance system. The national Salmonella surveillance system was actually established quite a long time ago, in 1962. But for a long time, it was a paper-based system where states would report an aggregate. This week, we had so many cases and their sex is such and the percent is such and so forth, up until the 1980s, when we implemented to the public health laboratory information system

Now, this system collects electronically isolate data, by serotype from public health laboratories. It is based upon the number of Salmonella isolates at public health laboratories. So, these isolates must be first cultured at clinical laboratories and hospitals and so forth, but it is routine that those laboratories then forward the isolates to public health laboratories for serotype characterization. They are then reported through this system.

Now, I'm going to talk first about a number of Salmonella serotypes. Here, we see a graph of the number of isolates in thousands on the Y axis. On the X axis is time in years. In the magenta line at the top, you will see Salmonella serotype Typhimurium. In the light blue line is Salmonella Enteritidis and then in yellow, Salmonella Heidelberg and in green, Salmonella Newport.

There is a large outbreak that occurred in the mid-1980s due to Salmonella Typhimurium in milk and it kind of skews the graphic. You can't see it very well, the details. So, I'm going to take that peak out and expand the Y axis to show you a little bit more the details.

So, this is the same graph, just without that peak in the middle and expanding the Y axis. You can see that, for many years, Typhimurium was the leading Salmonella serotype over time. Starting in the mid-1980s, you can see in the light blue line, Salmonella Enteritidis started to gain ground fast. By the mid-1990s, it became the most common serotype of Salmonellosis reported in the United States.

In the yellow, of course, is Salmonella Heidelberg. It made a run for the money there for a while and then tapered off thereafter. More recently, we have seen an increase in a number of Salmonella Newport isolates identified in the green line.

For both Salmonella Typhimurium and Salmonella Enteritidis, we have seen some fairly dramatic decreases, since the mid-1990s up until the present time where we have the last of our public data for 2002.

Concentrating now on just Salmonella Enteritidis, again, the number of isolates in thousands on the Y axis and time on the X. We can see that the peak number of Salmonella Enteritidis isolates reported to the CDC was 10,201 in 1995. In 2002, that number was about half, to 5,116. Between 2000 and 2002, right at the tail end here, we have another 18 percent decrease. But as a whole, from 1999 to 2002, it has not changed significantly.

Now, you all are also familiar that the Salmonella Enteritidis burden is quite different if you look at different regions of the country. Now here, we are looking at on the Y axis the rate as in the number of isolates per 100,000 people in the population. Since, obviously, different regions have different populations, we normalize it like that. Again, time on the X axis.

In green, you can see the New England states and in magenta, the mid-Atlantic states, in black, Pacific states. Those are the major regions where Salmonella has had an increase over those years. The other regions are in red and then the total in blue.

You can see in the mid--in the New England states, the rates were first increased in the late 1970s to the mid-1980s. But then, the mid-Atlantic states actually overtook that rate by the early 1990s. Since the mid-1990s, we have had fairly dramatic decreases in the rate of Salmonella Enteritidis reported to the CDC, especially for those states in the mid-Atlantic and New England regions.

I'm going to tell you a little bit about another surveillance system that we have at CDC. It is called FoodNet. FoodNet is a selected state public health departments in the United States, which participate in conducting active surveillance surveys and epidemiologic studies. I'll just give you a little detail about what we mean by active surveillance.

In the national Salmonella surveillance system, we depend upon the laboratories to forward their isolates to the public health laboratory and then, the states to voluntarily report to CDC. In this system, the states actually audit the records for laboratories in their areas and there can be hundreds of laboratories or potentially even more than a thousand in any one FoodNet area that they actually audit the clinical microbiology records and clinical laboratories to identify isolates for their surveillance.

They conduct surveillance for more than Salmonella. The bacteria that they conduct surveillance for is Salmonella Shigella species with Listeria Monocytogenes, E. Coli 0157:H7, Campylobactor species, vibrio species and Yersinia species.

Here are the FoodNet sites and this is what forms the network for FoodNet. You can see that the FoodNet network has expanded since its inception in 1996. At that time, the FoodNet population covered, coverage was about 14.3 million, but has now grown to include ten sites, with a catchment of about 36 million people or 13 percent of the U. S. population.

Now, in this graphic what FoodNet has done is relate the relative rates of Salmonella isolates reported through FoodNet compared to 1996. So, 1996 is pegged at a relative rate of one, as compared to itself. Each subsequent year is then compared to 1996 for a relative rate.

You can see that it decreased in the 1990s, but then increased somewhat until 2002, where when you compare 2002 and 1996, in the FoodNet catchment areas, it actually was not a significant change.

Now, FoodNet, as I mentioned, does surveys. The reason that they do surveys is, that in order to fill in what we call the surveillance pyramid. The surveillance pyramid is based upon this concept that the actual isolates that get reported to CDC are probably a small percentage or small proportion of the actual illnesses in the population.

So, you have at the bottom a population that is exposed, say, to Salmonella containing foods [sic]. From that population there becomes--a proportion becomes actually ill. A proportion of those actually seek care for their illness. Some of those, when they go to seek care, can be treated without a culture being taken or some of them will have a specimen obtained and then laboratories may or may not conduct the correct type of laboratory test in order to isolate the organism.

Then the proportion of culture-confirmed cases that are reported to the CDC.

What FoodNet has done, is they've done large population surveys to determine, of those who become ill, how many actually go on to seek care. Then they do physician surveys that estimate of those who are seen in clinics, hospitals, et cetera, how many of those patients actually have a specimen obtained. a laboratory survey to determine when a specimen is obtained in a laboratory, how many do the testing to actually isolate Salmonella and then the active surveillance to determine the reporting of culture-confirmed cases.

Now, when you add up all of those proportions, what you get is basically a multiplier where when you have in 2002 5,116 cases reported, you can determine that, for every case reported, there are approximately 38 that go unreported due to a lack of lab sensitivity, lack of cultures obtained or not seeking care. That then, when you multiply that out, would be an estimate in 2002 of 194,408 cases of Salmonella Enteritidis in the United States.

Now, what we have done is, we have estimated what would be a plausible range to this multiplier of 38. It is not technically a confidence interval, but the plausible range was calculated to be anywhere from 23 to 65 unreported cases for every case reported.

Now, I'm going to another surveillance system that we have and that is the SE Outbreak Surveillance. Outbreak Surveillance started in 1973 with the collection of paper reports, again. But the reporting forms and surveillance were enhanced in 1998. We actually started verifying reports with states in 1998 and when we went back and went through that trouble of verifying reports in all 50 states, then we found that there was a fairly large number of reports that were generated after verification.

In 2000, we introduced the Electronic Food-Borne Outbreak Reporting System, EFORS, which is an web-based reporting system. In 2001, all reports or outbreaks of food-borne illnesses had to be reported through the EFORS system.

Now, this gives you an idea of the overall number of food-borne outbreaks. This is not SE. This is not just Salmonella. It's food-borne outbreaks in total, starting from 1990. In the old, unenhanced system, I will call it, there is about 500 to 800 outbreaks reported each year. In 1998, when we initiated improved reporting, that number doubled. In the magenta, this is when we implemented the EFORS system for reporting. In 2002, the number of food-borne outbreaks reported to the CDC was 1,332.

Now, here are the outbreaks due to Salmonella Enteritidis from 1990 to 2002. You can see that there has been a decline over time. In 2002, there were 29 outbreaks reported to CDC. But this is not quite visually correct because, of course, there was an increase in overall outbreak reporting in 1998. So, the next slide, I'm going to correct for that by indicating that the excess is the percentage of all outbreaks that were due to SE.

So, in this graphic, you can see actually an even steeper decline in the number of outbreaks, as a percent of total over time until 2002.

This is the number of cases and outbreaks. You can see that the number of cases in the mid-1990s was around 2,000, between 2,000 and 3,000 cases in SE outbreaks in the United States. In 1994, you see a large spike there. Maybe some of you remember the Schwann's Ice Cream outbreak in which--I think that one alone was responsible for almost 4,000 cases.

But more recently, we have had, again, a decline in the number of cases and outbreaks; a little bit greater number in 2001, until we had just under a thousand cases in Salmonella Enteritidis outbreaks in 2002.

Now, when outbreaks are reported to us, we ask about where the outbreak occurred. What was the setting of the outbreak? So, where that was reported, commercial venues accounted for almost two-thirds of the settings for Salmonella Enteritidis outbreaks. By commercial settings, I mean restaurants, delis, bakeries, cafeterias, vending trucks, catered events, et cetera. Then there is about an equal distribution among other settings, including health institutions, in the home or a larger category called other.

Now, this slide looks at outbreaks between 1985 and 2002 by the vehicle that caused the Salmonella Enteritidis outbreak, meaning the food, which type of food it was.

Of 960 outbreaks during that time period, we identified the actual vehicle in the outbreak, we, meaning public health officials and states and local health departments, in almost half of those outbreaks. That is pretty consistent with the rates in which food vehicles are determined for outbreaks in general.

Now, if you look at those outbreaks in which the vehicle is determined and in which we can determine whether the vehicle was egg-associated, there is a little bit of difference in this denominator, 413 and 431, because some vehicles, even though we identified them, we could not determine whether an egg was a component.

We see that 79 percent of those determined vehicles were due to eggs or egg-associated. On the bottom, you can see the number of cases and outbreaks in general. Those were vehicle determined and then about 17,413 cases in outbreaks where it was egg-associated.

Now, that proportion, 79 percent or year by year, it could be 79, 80, et cetera, actually has been consistent over time. Although the outbreaks, the number of outbreaks has gone down, the SE outbreaks in which they were determined to be egg-associated was actually pretty consistent. That proportion was consistent. See, in the yellow portion of these bars where outbreaks where we could determined that it was egg-associated and then in the blue part is non-egg containing and then there is a gray portion there where we didn't know whether the implicated food was egg-associated or not.

So, that proportion has actually been quite consistent over time.

Here are the different types of egg-associated vehicles identified in those outbreaks, the largest proportion is in egg dishes or egg battered dishes, almost 32 percent, followed by desserts that contain eggs, 25 percent, sauces and dressings, 13 percent, pasta, 10. Then we have smaller proportions in pureed drinks, stuffings and then a multiple category.

Now, we are fairly comfortable in the determination of egg associations in these SE outbreaks. The reason why we are fairly comfortable in that is, because food-borne outbreak investigations are conducted by generating multiple hypotheses. Often times, when an outbreak is being investigated, they don't know the pathogen yet and they don't know the vehicle yet. So, you have to start fairly broad in generating hypotheses as to what might have caused it. You're not just looking for egg vehicles, although when it is known that it is SE, it would be--we always look for eggs, because that is a--historically we know a source of SE, but not just eggs, a number of other vehicles. Actually, SE has been associated with many food vehicles.

In addition, when trace back investigations are conclusive, SE of the same subtype is often identified on the farms of origin. So, that confirms what we found in outbreak investigations.

That being said, there is uncertainty in attributing the proportion of eggs in egg-associated outbreaks. That uncertainty is due to the fact that, when we estimate the total number of cases, we are actually attributing that same proportion where we know the food is associated to eggs to those outbreaks where we don't know the food. So, only half of the outbreaks have been identified with a food vehicle. And of course, what we have done in some estimates is apply that same proportion to those even when we don't know the food vehicle.

Also, outbreak associated cases are just a minority of all cases of Salmonella Enteritidis that occur. So, there is uncertainty--

[End tape 1, side 1 and begin tape 1, side 2, as follows.]

DR. BRADEN: [In progress] --you recognize the 79 percent as those that we found that our egg-associated outbreaks were food vehicles identified. That is in the top line.

We have also estimated a low range number. What we have done here is, we have taken the egg-associated number of cases and outbreaks here and applied it not just to whether the vehicle is determined, but just divided saying that, assuming that all those outbreaks, half of the outbreaks where a vehicle is not determined, we are going to say none of them are due to eggs. So, that low estimate is 53 percent and we have a mid-range estimate in there of 66. That's just the mid-range between 53 and 79.

Now, in estimating the number of SE cases due to eggs in the United States for 2001--this is the year that is used, year of surveillance that is used to calculate the number in the proposed egg rule. We use the reported number of SE cases, that is, 5,614. We use the FoodNet multiplier. And then FoodNet also has done surveys to determine how many people actually acquired their infection outside the United States. For this calculation, we are not interested in that. We want to know domestically acquired infections.

Then the proportion due to eggs, which we use the 66 mid-range estimate of the proportion. So, if you just do the math, what we have is 5,614 times 38. It gives you 213,332. You subtract out those that were due to foreign exposures, 16 percent. That gives you 179,200 and then you multiply that by the proportion, the mid-range proportion that we feel is appropriate due to eggs. That is 118,270, rounded to 118,000.

This is the number that you see in the estimate--excuse me--in the proposed egg rule that was published in the "Federal Register." Now, to follow the impact of regulations, we are going to be using this number with a goal of a 50 percent reduction by 2010, as you have heard.

Now, this is a slide that I think is fairly powerful, that looks at an analysis of the change in incidence of Salmonella Enteritidis infections in relation to the adoption of egg quality assurance programs in states. We are going to normalize that adoption by saying that, we are just going to say whatever year the egg quality assurance program was adopted in a state, we are going to call that year zero.

Of course, to the left, you have before the EQAPs were adopted and to the right, you have after EQAPs were adopted.

So, these are the axes. On the Y axis, what you have is the annualized percent change in the incidence of Salmonella Enteritidis, zero being no change, a positive 10 being an increase of ten percent by year and negative 10 being a decrease of ten percent by year and then the years before adoption and the year after adoption on the Y axis.

Now, on the green bars, there are four states in which we have data for five years after adoption. What you see is that, by year, in those states, there were fairly significant increases in the number of Salmonella--or excuse me--the rate of Salmonella Enteritidis for those years. Until the time of adoption of the EQAP program and each year thereafter, then they have had a decrease in the incidence of Salmonella Enteritidis in those states.

This is annualized so that, if you take those five years, about an average of eight percent a year reduction after the introduction of an EQAP for a total reduction in those five years of about 40 percent.

There are six states in which there are at least three years--excuse me--at the most, three years of post-adoption data and you see a similar trend in seven states in which there were at least two years of post-adoption data and, again, a similar state. This is then looking at the last bar, 11 states that have adopted EQAP programs at the time of this analysis. Bar none, after the introduction of a quality assurance program, they have had reductions in the proportions or in the rate of Salmonella Enteritidis.

I find this quite convincing, because we are quite aware that, in a particular state that adopts an EQAP program, it is not as though those farms that have those EQAP programs have saturated the market in those states. There are other states that import into those states, into that population and so forth. So, I think it is quite powerful that even given that you can't say that all the people in the state were covered by an EQAP when an EQAP program is implemented. We still see this decline.

These EQAP programs that are included in this analysis can be either state-sponsored or industry-sponsored for farms within that state. In addition, even when those--of course, you know that they are voluntary. So, not all farms within those states would have adopted it. Nonetheless, this is what we see.

So, conclusions.

There has been a nationwide decline in SE cases since 1996, but less so in recent years. There was no significant change in the rate of Salmonella Enteritidis infections in FoodNet states. There have been important declines in outbreaks, though a significant number of outbreaks occur. Control programs are making progress, but need to be widely adopted.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you, Dr. Braden.

We are now going to be turning to our next presentation. Again, hold your questions and/or other comments until the panel session.

Next, I would like to introduce Ms. Nancy Bufano, who is going to provide you an overview and description of the proposed rule.

[Pause]

 

[Presentation of FDA's Proposed Rule]

MS. BUFANO: Good morning.

I am going to provide a brief overview of the background of the rule, a detailed discussion of the rule's provisions. I will point out where FDA is seeking comment. I will briefly cover the economic analysis, which is the cost and benefits of the rule.

As both Lou Carson and Dr. Crawford stated earlier this morning, this proposed rule is just one step in a broader farm-to-table egg safety effort that includes FDA's requirements for safe handling statements on egg cartons and refrigerated storage of eggs at retail. Those have been in place now for about three years--and our egg safety education for both consumers and retail establishments, which is ongoing.

As you learned from Dr. Braden's presentation this morning, eggs are a major cause of food-borne illness. In the seven year period, beginning in 1993, an average of 80 percent of the source confirmed SE outbreaks were egg-associated. It is estimated that eggs cause approximately 118,000 SE illnesses per year.

We believe, FDA believes the best way to prevent SE illnesses is on the farm. Our approach was developed with support from, support and input from both industry and consumer groups. Many of you remember the public meetings we held several years ago to gain input from the public. We have used that input and we look forward to your continued input and your continued comments as we go forward with the final rule.

Our proposed requirements have already been tested at the state level, as you saw in Dr. Braden's presentation on the egg quality assurance programs. We know that these measures work.

The benefits of the proposed rule are $580 million and 33,000 illnesses avoided annually at a cost of $90 million annually. The health outcomes can be clearly measured.

From the onset, we used a risk assessment, risk management approach to the development of this rule. The 1998 USDA/FDA joint risk assessment on SE in eggs analyzed each step in the shell egg farm-to-table continuum to determine the relative risks at each step, that each step contributed to SE contamination of eggs. It revealed that preventive measures should be taken at each step in the continuum in order to maximize the health benefits.

The most effective preventive measures can be taken to prevent SE illnesses from--the most effective preventive measures that can be taken to prevent SE illness from eggs is to prevent eggs from becoming contaminated initially on the farm. We know that some infection is unavoidable. So, refrigeration throughout the food chain will stop any bacteria that is present from growing and pasteurization and/or thorough cooking will kill the bacteria, which is the reason we advocate safe handling statements on egg cartons for consumers and why we continue our education campaigns to both consumers and food service establishments.

I'm going to talk now about exactly what the regulation says.

Who is covered by this proposed rule? You are covered by all the requirements of this proposed rule if you--and this should say, have--this should be 3,000 or more layers instead of more than 3,000 layers. So, if you have 3,000 or more layers and you do not sell all of your eggs directly to consumers and any of your eggs are not treated--and I'll define treatment in the next slide -- you are covered.

I'm just going to say no; Windows is ready to update something.

You are covered only by the refrigeration requirements if you--again, this should say if you have 3,000 or more layers and you do not sell all of your eggs directly to consumers and all of your eggs are treated.

So, who is not covered? If you have fewer than 3,000 layers or if you sell all of your eggs directly to consumers, you are not covered by any requirements of the rule at all, completely exempted.

Treatment is defined in the proposed rule as a technology or process that achieves at least a five-log destruction of SE for shell eggs or it is the processing of egg products in accordance with the Egg Products Inspection Act.

The SE prevention measures outlined in the proposed rule include SE-free chicks, a biosecurity program, a rodent and pest control program, cleaning and disinfection of poultry houses and refrigeration of eggs on the farm. These are measures that can be taken during egg production at the farm that would reduce the risk of SE contamination of the eggs.

I'll go through each of these provisions.

Chicks and pullets must come as chicks from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for United States Salmonella Enteritidis monitored status or equivalent standards.

NPIP is a cooperative federal-state industry program for controlling certain pathogens and poultry diseases, including Salmonella Enteritidis.

Biosecurity applies -- would apply -- to the grounds as well as all the facilities, to reduce SE from environmental, personal and animal contact.

The proposed rule would require that you limit visitors to your farm and in your houses; that you restrict the movement of equipment between houses, so it is not a source of SE; that you restrict persons moving between the houses, so they are not a source of cross-contamination; that you prevent stray poultry and other animals from entering the grounds and that you do not allow your employees to keep poultry at home.

Rodent and pest control. We know that mice, rats and flies are primary carriers of SE and must be controlled. We know the presence of SE in rodent populations has been highly correlated with the presence of SE in poultry houses and in eggs. So, for these reasons, the proposed rule requires that you assess the population of rodents and pests, using an appropriate monitoring method and, if necessary, use an appropriate method to decrease those populations and that you remove debris within the houses and vegetation and debris outside houses that may harbor pests.

Cleaning and disinfection of poultry houses would only be required at depopulation, when either the house or the eggs from that house have tested positive for SE. The cleaning and disinfection procedures proposed in the rule require removing visible manure, dry cleaning, wet cleaning and then disinfecting using an appropriate disinfectant.

We know that refrigeration has shown to minimize the growth of any SE that may be present in eggs. So, for this reason, the rule proposes that eggs that are held at the farm for more than 36 hours after lay, be refrigerated at an ambient temperature of not more than 45 degrees Fahrenheit. This provision would apply to all eggs, regardless of whether or not they will receive a treatment, so whether they would go for pasteurization or to the table egg market.

To verify that your SE prevention measures are working, the proposed rule requires an environmental test for Salmonella Enteritidis once per laying cycle, when any group of hens in a house are 40 to 45 weeks of age. If that test is positive, you would be required to review and make adjustments to your SE prevention measures and either begin egg testing within 24 hours of being notified of the positive or divert all of your eggs from that positive house to a treatment for the life of that flock.

Now, if you do induce molting, an environmental test is also required approximately 20 weeks after each molt. If that is positive, the same provisions apply. You are to review and make adjustments to your SE prevention measures and then either begin egg testing within 24 hours or divert all the eggs from the positive house to treatment for the life of the flock in that house.

Egg testing is only required when an environmental test is positive. I have a flow chart on the next slide which, I think, will make this a little clearer. I'll go through first the steps in egg testing.

Each test consists of a thousand randomly collected eggs from one day's production. Four tests are required, a thousand eggs each and the four tests are done at two week intervals. If all those tests are negative, there is no further testing required. If any of those tests are positive, you must immediately divert all the eggs from that house to treatment.

If you wish to enter back into table egg production for the eggs from that house, you must begin again with the four tests at two week intervals until all those four tests are negative. Then you can go back into table egg production, but you still have to conduct one egg test per month for the life of that flock. If any of those tests are positive, you must immediately divert and begin again with the four tests at two week intervals if you want to go back into table egg production.

You always have the option of just continuing to divert and you would not have to test any more eggs as long as you are diverting.

Let me pull up the flow chart. I think this will make it clearer.

[Pause]

MS. BUFANO: I think it is pretty clear. You start with a thousand egg test, over here on the left of the chart. If that is negative, you wait two weeks and conduct another test. If it is positive, you divert and you want to go back into table--you can just continue to divert or you can go back. If you want to continue production for the table egg market, you go back and start again with a thousand egg test.

So, there are four of those thousand egg tests. If any of those are positive, you divert. If you want to go back into table egg production, again, it is going back and starting again with the four tests.

When you reach that fourth test, if that fourth test is negative, if it is negative and it's never been positive, you never had a positive, then no further testing is required. If that fourth test is negative, but you did have a positive, in other words, it is your second or third time through, you must continue to conduct one test per month for the life of that flock. If any of those tests are positive, again, you have to divert. If you want to continue to produce eggs for the table egg market, you have to start again with the four egg tests.

So, you always have the option of just continuing to divert. The egg testing is only required if you want to get back into table egg production after a positive egg test.

The methodology required for sampling--for environmental sampling, you must use a scientifically valid sampling procedure. The proposed rule discusses two environmental drag swab sampling procedures, but it also requests comments and data on drag swabbing methods and alternative methods of sampling that might be more uniform, for example, air sampling. So, we are asking for comments there. We will consider the comments and we will determine what method should be required in our final rule.

The testing methodology for environmental samples, it is Detection of Salmonella in Environmental Samples from Poultry Houses or an equivalent method. That, I believe, is in your packet. It is also on CFSAN's website.

For egg samples, it is the pre-enrichment method that is describe in the "Journal of Food Protection" or an equivalent. That method that is published in the "Journal of Food Protection" is a method that was actually developed by CFSAN researchers.

There must be one individual at each farm who is responsible for administration of your SE prevention measures. That individual must have completed training or have job experience that is equivalent to training. Their responsibilities include the development and implementation of SE prevention measures, reassessing and modifying the procedures as necessary and reviewing records.

That brings us to the recordkeeping requirements. The proposed rule requires the following records be kept; records of environmental and egg sampling and the results of SE testing, records indicating compliance with the diversion requirements, obviously, if necessary and records indicating that all eggs will undergo treatment, if applicable.

Guidance and training. FDA plans to publish guidance on the standards for each provision. Per our good guidance principles, each guidance will be published for comment prior to implementation. We are envisioning that we will probably publish draft guidance around the same time as we would publish the final rule. There will obviously be an implementation period for the final rule. During that time, we would collect comments on the guidance and then, obviously, publish final guidance before the rule would actually take effect, be implemented.

Training for both industry and government. We envision forming an alliance with industry similar to what we have done with juice HACCP and seafood HACCP, which have been very successful.

The small business provision in the rule, we exempt farms that have--this should say fewer than 3,000 layers. They are exempted from all the provisions. This exemption or this provision reduces the cost of the rule by $40 million, but it only allows for fewer than 200 additional illnesses.

How do we know that it works? We know that on-farm prevention measures work from specific states' experiences and from regional shifts in illnesses once controls were put in place. I think Dr. Braden's graph was even more convincing, but this graph just shows--the pink line shows the decrease in SE outbreaks just in the northeast after 1992, when Pennsylvania implemented their egg quality assurance program. So, this is just based on Pennsylvania's egg quality assurance program.

The goal of our egg safety program is outcome-based. Our current goal, as you have heard this morning, is to achieve a 50 percent reduction in egg-associated SE illnesses by the year 2010. We are incorporating this goal into the Healthy People 2010 initiative.

I'll go through the economic analysis very briefly.

The major benefits of the rule are preventing severe, acute cases of SE illnesses and death and preventing reactive arthritis as a chronic complication of acute illness. That's where the major benefits are derived. The major costs of the rule are pest control and biosecurity, refrigeration, testing and diversion and records.

The small business effects, as I stated earlier, are to exempt farms with fewer than 3,000 layers. It is important to note that most layer farms are small businesses.

The economic benefits. The economic benefits from averting 33,000 illnesses annually range from $250 million to $1 billion. This includes health care costs, the cost of pain and suffering and the cost due to lost productivity.

The cost savings just to Medicare, the Center for Medicare and Medicaid Services, for reduced medical costs is $4 million.

We have costs to industry and we have costs to government. The cost to industry is estimated to be $82 million. We estimate that approximately 4100 farms will be affected based on the following breakdown. Just over 2300 farms with 3,000 to less than 20,000 layers, 950 farms with 20,000 to fewer than 50,000 layers, 360 farms with 50,000 to fewer than 100,000 layers and 450 farms that have more than 100,000 layers.

What are the costs to government? These costs are based on the 4100 farm figure to us. That is 4100 inspection sites. FDA will inspect and enforce the rule with state and other federal agency partnerships. That is how we envision inspecting.

We, of course, are the enforcers. I should say that we will use state and other federal agency partnerships to inspect. We are the enforcement authority. Phased in over two to three years, the expected annual cost to the government is $8 million. That includes, among other things, state contracts, audits, lab testing, training and outreach for both industry and FDA.

To summarize the economic analysis, the benefits are exceptionally high, because of the present value of future reactive arthritis costs being prevented. The uncertainty analysis showed that even low level benefits are still much higher than the estimated costs.

The request for comments. We do, as you are reading through the preamble, the proposed rule, you will see that we do request comments in many areas. These three are the three main areas; measures for at-risk populations, registration and recordkeeping.

[End tape 1, side 2 and begin tape 2, side 1, as follows.]

MS. BUFANO: [In progress] --institutions that serve highly susceptible populations, such as, hospitals, nursing homes and daycare centers.

We are asking if the current FDA Food Code system with stated options and implementations achieves our desired public health outcome among high-risk populations or can that public health outcome only be achieved through mandatory federal standards. If so, how would those standards be best implemented and, specifically which of the egg-associated provisions in the 2001 Food Code should be mandated for those retail establishments that specifically serve at-risk populations?

So, again, we are talking about nursing homes, hospitals, daycare centers and the like. So, we are requesting comment there.

Also, specifically we are requesting comment on registration. Should FDA require producers to register the name and the location of their business with FDA? Most of you are probably aware that food production facilities are required to register with FDA under the Bio-Terrorism Act, but farms are specifically exempted. Farms are specifically exempted from registering under our interim rule, which we issued under the Bio-Terrorism Act.

So, egg producers are not registered under the Bio-Terrorism Act. So, we're asking if, indeed, they, if you think registration is a good idea. We will know where our farms are.

A final request for comment area that I will cover is recordkeeping. Should FDA expand the recordkeeping provisions that are in the proposed rule as it is now written to include establishment and maintenance of a written SE prevention plan and maintenance of records indicating performance and compliance in implementing specific SE prevention measures, for example, monitoring records and activity logs?

The participatory process we have used in developing this proposed rule was to set a public health goal, consult with industry, states, federal partners and consumers and use the lessons learned and the steps from existing egg quality assurance programs.

In enforcing the rule, we will determine if on-farm prevention measures are in place and are being administered, if eggs have been tested and the results of those tests and if SE positive eggs have been diverted.

The resources we will use to enforce the rule, as I said before, the rule will be enforced by FDA. We are considering contracts with states and other federal partners to assist us in our inspection efforts.

As Lou told you earlier, we are holding three public meetings. Our first one was in College Park, Maryland on October 28th, today's meeting and then next week, next Tuesday, we are in Los Angeles. The comment period is 90 days. It ends December 21st.

In conclusion, we expect this proposed rule will, if finalized, significantly decrease the number of SE contaminated eggs produced on-farms and, ultimately, decrease the number of SE associated illnesses and deaths caused by consumption of shell eggs.

 

[FDA and CDC Panel: Stakeholder Questions and Answers]

DEPUTY DIRECTOR CARSON: Okay, now we are going to be taking your questions. What I would ask you is, this meeting is being taped so that we can transcribe it. So, as you want to either offer a question or a comment, please come up to the microphone there in the center. Please state your name, your affiliation and then your question or your comment.

So, are there any questions at this time?

QUESTION: I may as well ask a question, for Dr. Braden.

My name is Todd Macklin[ph]. I'm with Cargill[ph].

For Dr. Braden, you did a summary of outbreak investigations. I was wondering, can you tell us how many outbreaks have been associated with pasteurized eggs? Have there been any?

DR. BRADEN: Yeah. We have not identified any outbreaks due to pasteurized eggs. Given the limitations of outbreak investigations, I can say that.

MR. MACKLIN: Right, okay, thank you.

One other question. How many states have codified the standards for the Model Food Code? How many states have actually adopted that; do you know?

DR. BRADEN: I don't know that we have the specific information. We have heard anecdotally that it is somewhere less than ten states have formally adopted all of the egg-associated measures that are in the Food Code. More than that number probably have adopted some of the measures, but not all.

MR. MACKLIN: Right, thank you.

DEPUTY DIRECTOR CARSON: Richard?

MR. WOOD: Hi, I'm Richard Wood from FACT, Food-Animal Concerns Trust. We are based here in Chicago.

Our first couple of questions for the CDC are, does--you presented three sources of SE data, one from surveillance labs, FoodNet and the outbreak surveillance. This may be a stupid question, but I was wondering--I mean, and the way you came up with the method of determining overall the likelihood of SE from shell eggs was to combine all three or to put them together in some kind of formula.

Is there any danger--and this is not a loaded question. But is there any danger of mixing--is this mixing apples and oranges and other--there are some assumptions with looking at, you know, with looking at [unintell] laboratory tests and gathering data from that, that really doesn't mix with gathering data from FoodNet or looking at outbreaks.

DR. BRADEN: You bring up a good point. They are three different systems and there is a--I guess, if you wanted let apples and oranges [sic], this is a juice combo and there are limitations in doing that.

We--I, I tried to outline some of the limitations in that and there is a lot of concern about applying the proportion of outbreak association cases due to eggs to the general population of illnesses, of SE illnesses. We tried to address that by coming up with some reasonable spread of bounds, so that you can say that there is a kind of an interval that we would be comfortable with, with the multiplier, for instance. That was not taken into account for this particular point estimate, but you could go back and back calculate what that--what would be the bounds of the number of cases given, you know, that 38 point estimate.

That is just actually high. It could go up to over, say, like 300,000 cases if you did that, using the extreme upper limit of those bounds. So, this is all part of what we call modeling. The outcome is not exact. You have to take it as an estimate and we try to put some bounds on it, especially when publishing this number.

MR. WOOD: And your last slide did indicate that SE does show--the last slide did indicate in all three methods that, SE related to shell eggs is still the major issue and the major problem.

On the slide that you looked at the annualized change of incidents of SE related to the adoption of egg quality assurance programs, you were looking only at state programs, not industry programs, because I thought I saw a slide not from you, at this meeting or others, but a year ago or so on a study that came from the CDC that looked at comparing state-mandated programs from voluntary programs that were egg quality assurance, like FACT had on its farms in Pennsylvania. But actually it showed that the state programs did have a higher success rate of reducing SE.

But I just wanted to clarify that this slide was looking only at state programs; is that correct?

DR. BRADEN: No, it actually includes farms in states where they have industry-implemented egg quality assurance programs, in addition to state-sponsored programs.

MR. WOOD: Okay, did it look at--I mean, did it look at states that had both or did it look at states that had one or the other?

DR. BRADEN: If they had both, they were included.

MR. WOOD: Okay.

DR. BRADEN: If they had one or the other, they were included.

I just wanted to point out that, that graphic is in a publication. So, you can read the details.

MR. WOOD: All right.

DR. BRADEN: The publication is from last month, the October issue of the "Emerging Infectious Diseases Journal." You can go--that journal has public access at www.cdc.gov website. Go to the "Emerging Infectious Diseases Journal" link. You go to the past editions, the October. You can print that out in a PDF. That's what I did again last night to--and it--there has been some attempt at an analysis between, the difference between just industry-sponsored and state-sponsored.

There is not enough data there to say that there is a statistical difference.

MR. WOOD: All right and, again--

DR. BRADEN: But we do tend to see some better outcome. There is a trend with state-sponsored.

MR. WOOD: This will be in our comments, but FACT certainly supports lowering the playing field, so there is common ground among all states.

Thank you.

Can I ask Nancy the final?

On your egg testing chart and in the rule, if there is a positive, you require a second--a diversion. When you get to the egg testing positives, you require another--a diversion and then another test in two weeks. Is there any reason for the two-week lapse, I mean, or am I misunderstanding that? Can a second test happen immediately if there is a positive or do you have to wait two weeks?

MS. BUFANO: No.

Do you want to bring up the slide?

[Pause]

MS. BUFANO: Are you talking about if there is a positive egg test, right?

MR. WOOD: Yeah, right.

MS. BUFANO: [Off microphone]

If any of, if any of these four tests are positive, you immediately have to divert and if you want to go back into table egg production, you immediately start again with a thousand egg test--

MR. WOOD: [Speaking simultaneously]

So, you can do a test right away--

MS. BUFANO: You go two weeks.

MR. WOOD: [Speaking simultaneously]

So--

MS. BUFANO: The two weeks are only between if you have a negative.

MR. WOOD: Oh, okay.

MS. BUFANO: You wait two weeks.

MR. WOOD: Okay, all right.

On the small business provision, the cost of redo--by not having farms of less than 3,000 layers and the cost federally is reducing it, your cost by 40 million, that's assuming that the same program, the same protocol and the same regulatory program for flocks larger than 3,000 would also for flocks less than 3,000?

DR. BROWN: That's correct.

MS. BUFANO: That's right, all right.

MR. WOOD: Okay. If there was a different protocol for flocks less than 3,000, the cost for the FDA would be, could be much less?

DR. BROWN: Yes, there is--we also--in the rule, we calculated the incremental costs to farms of less than 3,000 for each provision.

MR. WOOD: Okay, all right.

And on the slide that talks about the annual cost to industry, 82 million annually, 40--4,100 farms affected and then below that, you lay out the different number of farms with the different size of flocks. The proportion of costs would probably be different based on the number of hens or the size of the flock, right?

DR. BROWN: That's correct.

MR. WOOD: Okay, all right.

And did you calculate that?

DR. BROWN: Yes. Which breakout?

MR. WOOD: Oh, I was just--I don't want you to calculate it now. But, I mean, that is calculated in the rule?

DR. BROWN: Yes.

MR. WOOD: I must have just missed it, okay.

DR. BROWN: Well, yes, all the information is available there. You might have to use a calculator.

MR. WOOD: That's great. Okay, good. Thank you very much.

DEPUTY DIRECTOR CARSON: The range is from 19 cents up to one dollar per layer within that range. We didn't do each one of those breakouts by cost. That is the range of costs for implementing the on-farm measures.

MR. WOOD: Right.

I will make this a comment, during my comments. But just in passing, at FACT, with the farms we worked with in Pennsylvania, the costs for SE testing were very low and were to be spread out over time. And with a level playing field across the nation, those costs ought to be well absorbed.

So, thank you.

DR. BROWN: Okay.

The next question, Duffy?

MR. COX: Duffy Cox, from National Pasteurized Eggs.

Dr. Braden, the last study of the annualized change in incidence of SE, has there been any other connection with any other food safety programs like the Model Food Code or state-based provisions that might have affected this data outside of the egg quality assurance programs?

DR. BRADEN: Certainly, there were a number of programs in effect through that period of time that we were looking at.

MR. COX: You mean, that might have overlayed [sic] on the data that would, perhaps, say that--

DR. BRADEN: Yeah.

MR. COX: --you know, half of this was a result of retail-based food safety programs as opposed to just egg quality assurance programs?

DR. BRADEN: Well, certainly that would be the case if all of those other interventions were adopted at the same time as the egg quality assurance program. But that is actually not the case. Those other types of prevention programs were adopted at times, I think almost invariably, different from the specific year of adoption of egg quality assurance programs.

MR. COX: But they overlayed [sic] the specific times? For example, in Pennsylvania, we know that the food safety rules and how you handle eggs in those programs changed dramatically in the late '90s, probably just about the same time as the egg quality assurance programs were being implemented.

DR. BRADEN: That's right.

The point that we're making here and what gives us some confidence that this is actually due to the egg quality assurance program is that, going up into the year of the adoption of the egg quality assurance program, often times those prior years would have included these other control programs. But you still saw an increase. It was only the egg quality assurance program [unintell] invitation after which you saw the decrease.

Now, could there have been some interaction with these other types of programs? Yes, but we believe that, you know, given that it was normalized just on the adoption of the egg quality assurance programs and that the fact that these other programs were adopted in years other than that, that point change really reflects a significant--

MR. COX: Well, perhaps the date to look at would be the isolation of SE in states that have adopted, for example, the Model Food Code, but have not instituted state-based egg quality assurance programs.

DR. BRADEN: We could do separate analyses on those particular ones where we would see what the effect of individual other control programs, what the effect would have been. This is concentrated on the egg quality assurance programs.

But we realize that other things were going on at the same time. We feel that this graph is particularly powerful, because you see this kind of dramatic shift at that time of the egg quality assurance programs. Whereas, the other control programs were--

MR. COX: [Speaking simultaneously]

Yeah, I think I agree with that as well. I was just curious if there was some kind of an overlap of the effects of both. Obviously, the Model Food Code had some impact across the nation.

DR. BRADEN: Sure. We are not trying to downplay the effects of those other types of interventions.

MR. COX: Good, thank you.

DEPUTY DIRECTOR CARSON: Are there any other questions?

Yes, sir?

MR. MCBEE: Yes, Larry McBee, Rose Acre Farms.

Dr. Braden, I appreciate your presentation of data, a lot of data that is sometimes a bit confusing. But in one of your earlier slides, you indicate the frequency of Salmonella isolates and you indicate that in the mid-'90s, there was a major reduction in overall Salmonella isolations.

I guess my question would be, is it the egg assurance programs that have been attributed to that or other things, such as, refrigeration or industry programs that have provided the control?

DR. BRADEN: The risk assessment would lead us to believe that all of these interventions have, in effect, had a positive effect on the rate of SE illnesses. So, I think it is a combined effect that we are seeing. It's not just the egg quality assurance program. It's not just the refrigeration regulations. It's not just education of consumers, but all combined.

Common sense would tell you that, that approach would have the most combined effect, but this being a meeting mostly focused on the egg quality assurance programs, I brought in an emphasis on the egg quality assurance program effect at the end there to show that particular data.

We actually don't have, as per the previous speaker, we haven't done that same type of analysis on, say, the refrigeration rule. It would be very difficult to do on education.

MR. MCBEE: I think education of the consumer is a very important area that needs to be pumped up.

DR. BRADEN: Yes, it has been, I think, an area of active intervention. You can argue if it has been active enough.

MR. MCBEE: Yes.

Now, going to the location of outbreaks according to the location of food preparation, perhaps you could clarify for me the number of 960. It that the total isolates that were investigated as to the location over the period of 1985 to 2002 or is that only for the year of 2002?

DR. BRADEN: No, that's during that whole time period. It is the number of outbreaks in that time period.

MR. MCBEE: Okay.

DR. BRADEN: So, not isolates, it is the number of outbreaks in that time period.

MR. MCBEE: Okay.

Has that--was there any pattern in terms of the location of the food preparation?

DR. BRADEN: Any change over time?

MR. MCBEE: Yes, change over time?

DR. BRADEN: That is another proportion that has stayed relative constant.

MR. MCBEE: Okay, thank you.

Nancy, if I may address a couple of questions to you. The issue of farm sales and home flocks, in other words, those flocks that would be less than 3,000 birds--I guess it is more of a comment than not. It's my opinion that we need to look very closely at those sources of eggs as being, perhaps, less regulated than those of larger production flocks.

Also, an particular question which may be more of a comment also here is that, we do have a goal and I thank you very much for giving us a goal to measure our achievement in reduction of SE infections. As in meeting many goals, is there going to be a reward besides having safer, healthier people in particular for industry who is investing in this program?

DEPUTY DIRECTOR CARSON: Is that a comment or a question?

MR. MCBEE: That's a question.

DEPUTY DIRECTOR CARSON: Oh, because you prefaced by a comment, okay.

I'm not sure in what sense you're looking for a reward. Certainly, it is incumbent upon industry to produce safe food. Whenever you can reduce illnesses and deaths associated with the product you produce, I believe you're achieving your goal as a businessman. So, FDA does not have any goal other than that in mind, of protecting the public health.

MR. MCBEE: Would it be reasonable to assume that when this goal is met, the program would be disbanded.

DEPUTY DIRECTOR CARSON: No, we don't see why you would disband it. I mean, the mere fact that the program is in place is why it's achieving its goal. To disband it would return, we think, back to an increase in SE illnesses.

As you can see, this program is not eliminating SE. It is reducing SE and reducing it by 50 percent still means there are going to be SE illnesses and we would still remain steadfast in trying to reduce them to the lowest level possible.

MR. MCBEE: On the issue of labeling, would there be an opportunity for industry to label products from farms that are cooperating with this program in some way to differentiate them from other programs?

DEPUTY DIRECTOR CARSON: Well, again, the rule as we are proposing it would cover all egg producers. So, there would be no egg producers not already covered by this program. So, there would not be any differences between Rose Acre Farms' eggs and another producer's eggs, because they are all to be covered by this program.

I think your question, though, goes would you be allowed to label your eggs because they are now covered by this program by some other marketing labeling. We would certainly appreciate comments to that effect to the docket so that we can consider that.

MR. MCBEE: Thank you very much.

DEPUTY DIRECTOR CARSON: Yes, sir?

MR. COLCABICK: Ken Colcabick[ph], University of Illinois.

My question actually may be just a clarification on the annual cost to the industry and, you estimated $82 million annually. Is this, you know, when the producer signs up or registers with the program, does the cost actually--do they actually get a bill, for example, or is the cost absorbed into things that they are already doing like monitoring flocks and doing biosecurity measures? Is that a part of that cost or do they actually get a--you know, have to pay FDA a charge a fee in regards to that or is the cost absorbed in doing the business?

DEPUTY DIRECTOR CARSON: Well, let me first answer and then I will turn it over to Dr. Brown.

The $82 million is an estimate of the cost that will be imposed upon industry to implement each and every one of the on-farm measures. So, there is a cost associated with a rodent and pest control. When you multiply that by the number of farms we believe covered, 4100, the number of layers, then that is how you would arrive at that specific cost. So, the aggregate cost of all the measures being implemented by industry, by those 4100 farms would amount to $82 million.

There is no money coming to FDA. This is money or funds or expenses incurred by producers to implement these rules.

Now, again, we do ask for comments. So, we have gone out and costed each one of these preventive measures. If you believe our cost estimates are not accurate, we would certainly appreciate comments to what you believe those costs really are.

These are costs in addition to what steps are already being taken by egg producers, as we know and, has already been commented on. Many producers participate in egg quality assurance programs. Those egg quality assurance programs have some of these measures as part of those programs, not all and not all of these measures. So, some producers already have a rodent and pest control program, for example.

So, what we are estimating as these $82 million are the incremental increase costs to what is already in place.

Dr. Brown, is there anything else to add?

DR. BROWN: No, you got it, except for we actually also cover--it's not just farms that are already in the egg quality assurance programs that have some of these provisions in place already.

MR. COLCABICK: Thank you.

MR. GILLUM: Jim Gillum, with Henningsen Foods.

Our company produces shell eggs strictly for the breaking and pasteurizing of egg products. Can you comment on your efforts at coordination with FSIS, particularly in terms of the refrigeration proposal and diversion part of your rule and how that might affect their setting of pasteurization performance standards?

MR. CARSON: Do you want me to answer?

We have certainly worked closely with the Food Safety and Inspection Service. We--first off on your question about refrigeration, as we have proposed, if your eggs are dedicated totally to an egg breaker operation, then you are only required to have refrigeration on the farm.

As far as diversion is concerned, yes, we have certainly informed and worked with not only FSIS but AMS with their grading programs. Based on--if those eggs were to come up positive for the diversion of those eggs to egg breaker operations, based on our public meetings in the year 2000, there was some concern raised about the capacity of egg breaker operations to handle diverted eggs. We still are aware of that concern, but we do believe that there aren't any other options that we can see once you have had a positive egg.

However, we will certainly take comment if you have other options that you believe are appropriate for us to meet our public health goal.

Are there any other questions?

Yes, sir?

MR. CROUSE: I'm Bob Crouse[ph], with Midwest Poultry Services in Indiana.

I wanted to go back to a point that Mr. McBee had made about labeling. Primarily, Mr. Carson, you made this statement that, this applies to all eggs. When Nancy was speaking, she said that under the economic analysis, most layer farms are small businesses and, therefore, exempt from the--

DEPUTY DIRECTOR CARSON: Well, yeah, can I clarify that slide?

MR. CROUSE: No, that's all right. I think I more or less understand it.

One of the concerns I have and I think a lot of people in the industry have is that, you know, a lot of outbreaks and illnesses may come from smaller farms that aren't going to the same level of quality assurance that the larger farms are and it seems that there might be some benefit from being able to label eggs or to state on our labels that these eggs do follow FDA guidelines, so that a consumer is aware when they are buying an egg at a farmers' market or from the guy down the street--

[End tape 2, side 1 and begin tape 2, side 2, as follows.]

MS. BUFANO: [In progress] --exempting those farms that have fewer than 3,000 layers.

DEPUTY DIRECTOR CARSON: Are there any other questions for clarification at this time?

Howard?

MR. MAGWIRE: Howard Magwire, United Egg Producers.

Just one question that I forgot to ask in D.C. When you are estimating FDA's cost, do you anticipate FDA doing egg testing also, for example, for somebody who is not complying?

MR. CARSON: When we calculated the $8 million, we estimated some egg testing as part of that. That would be when FDA would go in and conduct and inspection either by state, FDA or others and we would collect samples to verify that steps had been taken if there was a problem or other reasons to take samples for us to conduct either environmental or egg testing on our own.

So, we were simply allowing for that egg testing to occur.

Your question goes to if we, upon an inspection, we find that a producer has failed to conduct testing as prescribed by our on-farm measures, then we have a number of enforcement tools to use at that point in time. We would obviously probably do some testing and to see what the state of that farm is. We would likely take some enforcement action on that farm as well, over and beyond the testing we might do.

MR. MAGWIRE: Thank you.

DR. DUTTON: Rich Dutton of Michael Foods.

The question just came because of Howard's comment. Has any evaluation been made of the ability of laboratories to actually do the testing? There is pretty significant testing if diversion takes place.

MR. CARSON: Well, we have certainly in our proposed rule asked for comment about the laboratory capacity. We have not done a study of laboratory capacity to do the shell egg or environmental testing. We do know of methods that are available. We do know the relative costs for doing that. We would need to check on the capacity for that.

Often times, with new rules, new capacity grows and new operations are put into place. So, we know Silliker[ph] and other laboratories would likely gear up to do such, if called upon by producers.

MS. STRONGER: I am Pat Stronger, with Daybreak Foods, Lake Mills, Wisconsin.

Actually, my question ties in with Rich's a bit. That is, are there certified--is there a requirement in the regulation for a certified lab to do, it can be--you know, at some of our facilities, we have our own labs, as do many of the producers here.

DEPUTY DIRECTOR CARSON: There are no provisions in the rules for certification of laboratories. In FDA, we put forward a performance measure or method. We say you need this method or its equivalent may be used to conduct the test either for the environmental or egg testing. So, we simply put out a method that your laboratory may use.

So, upon an inspection, we would look at those laboratory data and verification that those methods were in operation. As you conduct those tests, you general run quality assurance or quality control samples associated with that, to show that the performance of the method is sound in that laboratory and that the tests are truly showing you either positives or negatives, as appropriate.

MS. STRONGER: You kind of touched on the second part of my question. That is that, we currently do some rapid testing and it is not the official BAM method or what not, but we do have correlation studies that we run routinely with, you know, the quote-unquote official method. It's more effective, I find, on a farm where we don't have the expensive lab, not to mention the staff to keep a closer tie on what we are doing on the farm.

I'm wondering if that would be deemed appropriate and adequate?

DEPUTY DIRECTOR CARSON: We would certainly appreciate you submitting the type of test that you are using and any data you have associated with that rapid test. We are certainly looking at the most efficient way to do this and the least costly way to do this. So, if you have some information on that, we would greatly appreciate it.

MS. STRONGER: Okay.

The other question I had was just some of the wording in the regulation I'm reading now. It seems to be a bit over prescriptive. I think as part of the liquid egg market, we deal with an antiquated egg regulations that really are not state of art. They are not best practices, but we are still tied to following the regulations when, I think even the FSIS feels that there are better ways. Yet, we have our regulations we must follow.

I'm asking for some consideration. For example, for the regulations to say that employees must change clothing between going from one barn to the next or that you must wet clean your barn when we are going to find out, next year, there's going to be a super bug and that's the last thing you should do, is wet clean a barn.

I would just ask that the final wording take into account unknowns and best practices to be developed in the future and that, you know, we really just focus of what is the method here--I mean, not method, but what is the end point. The end point is for safer food supplies, so not to get overly prescriptive.

DEPUTY DIRECTOR CARSON: Thank you for that comment.

Our intention is not to codify those specific programs, but to do that as part of guidance. What that allows us to do is to take into account more rapidly new science or new best practices, just as you have mentioned, so we can modify guidance. But as we issue guidance associated with biosecurity or whatever preventive measure, we will put it out for public comment. You will have an opportunity to supply those comments. We will take those into account as we put out a final guidance to implement that.

All of the guidances are continually open for comment. So, even though we have issued guidance, let's say, upon--coincidental to the rule, we will still accept comment and change for an analytical method, for a biosecurity program and we will review that data and information that you submit to us and we will then put out a finding through guidance to say, this program is equivalent to the other. If you choose this one, that will be fine or to that effect.

MS. STRONGER: So, those guidance documents would be available even after the proposal is finally in effect?

DEPUTY DIRECTOR CARSON: Even after the--yes, that is true.

MS. STRONGER: Okay.

DEPUTY DIRECTOR CARSON: So, we are trying--the codified part of the rule will have the framework and within the framework, we will define, through guidance, what is the biosecurity program. We recognize that there will be new science, new ways to improve that over time. So, we will have to modify and update those guidances as needed or with the music in the background.

MS. STRONGER: A last question is, with the FDA and the inspection, will that be an announced inspection? I find that different producers have different biosecurity requirements, different visitor policies. Ours tend to be more stringent than quote-unquote, you know, whatever the number of hours are that other agencies might require. I wonder how much control we would have over having an inspector come on site, unannounced and we are not comfortable with where that person has been and how many hours preceding--

DEPUTY DIRECTOR CARSON: Again, I think that is a comment you should make to the docket. Generally speaking, the FDA does conduct unannounced inspections. We do recognize that biosecurity is an important part of what we see as on-farm measures. So, we're going to have to abide by biosecurity and not breaching that.

Having said that, we do believe it is in our best interests to have unannounced inspections but, again, we will perhaps need to work with industry to see how best to conduct that.

MS. STRONGER: Okay, thank you.

DEPUTY DIRECTOR CARSON: Are there any other questions?

Yes.

MR. CROUSE: Bob Crouse, with Midwest Poultry, again.

I have a question on the economic analysis. I'm wondering if it takes into account the market effect of the reduction in value of eggs that are diverted, because if those eggs are sold at a value less than where they were before they were diverted, it would almost certainly cause a drop in the market, which would have a pretty significant impact on the entire industry.

A one cent per dozen change in the price of the eggs and the commodity price of eggs on the [unintell] Market equates to about a million dollars a week to the industry. So, it doesn't take a lot for the egg markets to be affected by something like a diversion program.

I'm wondering if that was considered?

DR. BROWN: The difference in the price of a diverted egg actually is taken into account.

MR. CROUSE: Not the cost of the diverted egg, but the effect that that diverted egg has on the national egg market price.

DR. BROWN: No, that is not taken into account. If you have data on the cost to industry for that, we would appreciate comment.

MR. CROUSE: Okay, I think that is probably a comment that will be provided.

Thank you.

DEPUTY DIRECTOR CARSON: Are there any other questions at this time?

Yes, sir?

MR. THOMPSON: Dave Thompson, Pearl Valley Eggs.

Have you considered paying an indemnity to the producer if the producer cannot--I'm concerned the breaker plants may not take these diverted eggs. If we don't have anywhere to go with the eggs, we don't get any return for them. I feel that we should be paid an indemnity.

Have you considered that; have you thought about doing that?

DEPUTY DIRECTOR CARSON: FDA and HHS do not have indemnity authority. We do not have cost recovery for such acts that FDA would--through enforcement for any product. So, we do not have the wherewithal to provide indemnity at this time.

MR. THOMPSON: Is there a way that issue could be addressed?

DEPUTY DIRECTOR CARSON: Through legislation and appropriations, perhaps. But HHS does not have that authority. Only a part of USDA has that authority and it's not even FSIS. It is beyond FSIS as well. That is a comment that you can certainly make.

This is not unlike any other food product that FDA would take enforcement action against. Producers have lost monies based on enforcement actions FDA has taken to remove product from the marketplace. Again, your comment should be made to the docket on that.

MR. THOMPSON: Thank you.

DEPUTY DIRECTOR CARSON: Okay, we are going to take a 15-minute break and then we will come back for the public comments.

[Whereupon, a brief recess was taken and then the proceedings in this matter continued, as follows.]

 

[Stakeholder Public Statements]

DEPUTY DIRECTOR CARSON: Okay.

As I mentioned, our proposed rule is open for public comment until December 21st. We are offering this opportunity today for you to make public comment concerning the proposed rule.

I have four registered companies or persons who wish to make comments. Once they are finished, we will again open it up to the rest of the audience if you wish to make any additional comments.

So, first, John Mueller, Sparbo [sic] Company.

MR. MUELLER: Greg Murch is here from Sparbo Companies and he is our Senior Vice President of Operations and Production, so much more on the farm than I. So, he is going to submit our comments.

DEPUTY DIRECTOR CARSON: Okay.

If you would, when you get up to the mic, please give your name and your affiliation, please.

MR. MURCH: Thank you for the opportunity to testify on FDA's egg safety rule.

I'm Greg Murch. I'm Senior Vice President of Operations for the Sparbo Company. We are an egg producer, shell egg processor and further egg processor, with operations in Minnesota, Iowa and Colorado. We currently own about 13 million layers and are the fifth largest egg producer in the United States. We operate seven egg grading facilities and three value added egg processing facilities.

The Sparbo Companies are dedicated to providing a safe product to our customers. We follow the United Egg Producers Five-Star Quality Assurance program, utilize the USDA in-plant grading service and consider food safety as a cornerstone of our egg quality program.

When FDA began discussing the egg safety action plan some five years ago, we felt the original form of the plan was unduly burdensome, overly expensive and unnecessarily prescriptive. Therefore, we appreciate the agency's modification to the original concept or concepts to make it more practical. That does not mean, however, that the proposed rule is perfect.

We believe that a number of issues still need to be addressed. Among those issues, concerns we deem the following as most critical.

Number one, include in your proposed program an option, for producers who choose to use it, a scientifically approved Salmonella Enteritidis vaccination program to reduce potential SE shedding. With hundreds of flocks currently being vaccinated and with the positive results it has achieved in Great Britain using vaccines, we believe there is sufficient data to recommend a vaccination program.

As an incentive to follow this vaccination program, the following changes in the mandated program should be accepted. A, environmental testing would only be necessary once during the life of the flock. This environmental test should be completed within eight weeks of depopulation.

B, if an environmental tests positive, removing all visible manure and wet cleaning is not practical or reasonable. Dry cleaning and utilizing a formalin for disinfectant should be sufficient, again, with a viable, ongoing SE vaccination program.

Two, allow biosecurity regulations and clothing to be farm-specific, not barn-specific. Changing clothes between barns is not practical. Producers have alternative methods of bio-securing their operations and FDA should be concerned with results, not procedures.

Three, further mandate policies of safe storage, handling and cooking of eggs and egg products by all participants in the food handling chain. Cooking is the single critical control point in eliminating exposure to Salmonella Enteritidis in eggs. We know what heat does to Salmonella Enteritidis. We only think we know what must be done to reduce SE in the layer house.

Four, change the maximum temperature for storage of shell eggs on the farm and prior to processing, to 60 degrees Fahrenheit, with the maximum hold time of seven days. This will provide sufficient time to process the eggs without creating thermal checks and as scientific tests have shown, without increasing the risk of SE. Eggs held longer than seven days will have to be held under 45 degrees.

Change the 24-hour testing requirement after an SE positive to 72 hours between the findings of an environmental positive swab and the egg testing. This extra time allows for weekends and holidays when laboratory facilities would be unavailable. Again, that is changing the 24-hour testing to a 72-hour testing.

The FDA has no jurisdiction with regard to molting and a husbandry practice. As recent research demonstrates, molting has little, if any, impact on SE shedding from hens. The animal care programs are voluntary and we believe that the government needs to allow us to deal with the animal rights activists and our own customers on our own volition.

Seven, it would seem reasonable that, A, USDA/AMS provide the inspection and enforcement of the rule. A majority of egg producers/processors have longstanding histories of working with this agency. AMS is currently providing quarterly inspections of our egg grading facilities. In many cases, AMS utilizes state agencies who administer the state egg quality assurance programs, which have already demonstrated their usefulness in reducing Salmonella Enteritidis.

Eight, given today's organic and free-range flocks, the FDA program needs to cover all hens, even those producers with 3,000 or less birds. If food safety is the issue, all shell eggs produced should come under this regulation, assuring the consumers that all eggs are covered under the same standards. Eggs purchased directly from the ultimate consumer from the direct producer could be exempt to eliminate small, backyard flocks.

Again, if the vaccination program was in effect, this would eliminate some of the cost in those 3,000 and under flocks.

My comments today reflect or mirror fairly closely those comments and suggestions made by other egg producers and/or United Egg Producers. I would be less than honest if I were to say that there was universal agreement with the proposed rule within our industry. There is not.

However, we believe that the foregoing issues need to be addressed. We will be submitting written comments by the deadline of December 22nd to supplement the points we have referenced in our testimony here today.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you, sir.

Next is Robert Crouse, Midwest Poultry Services.

MR. CROUSE: Thank you for the chance to comment on the FDA's proposed shell egg safety rule.

My name is Robert Crouse and I'm an egg producer from Indiana. Today, however, I am speaking as a representative of United Egg Producers. I am a member of the board of directors and would like my comments today to be registered as part of United Egg Producers.

United Egg Producers is a trade organization whose members produce over 90 percent of all shell eggs in the United States. Egg farmers are dedicated to providing a safe product to our customers. The UEP designed the Five-Star Quality Assurance Program, which producers across the nation have implemented. This program has also been formally adopted by several states. In addition, our members take part in other egg quality assurance programs designed by various states.

These egg quality assurance programs have made a quantifiable difference. The Centers for Disease Control and Prevention published an impressive study of state and industry quality assurance programs, which concluded--and I quote--that egg quality assurance programs probably played a major role in reducing Salmonella Enteritidis illnesses in the United States. Even one egg-related illness is one too many. However, we should not ignore the progress that has been made.

CDC FoodNet data show that the incidence of SE per 100,000 people in 2003 was below both 2001 and 2002 levels. Outbreak data published by the CDC show that, in 2002, the number of SE outbreaks was the lowest since 1985, while the number of cases involved in these outbreaks was the lowest since 1998.

When the FDA began to discuss its egg safety action plan some five years ago, many producers felt that the original form of the plan was unduly burdensome, overly expensive and unnecessarily prescriptive. However, the agency modified its original concepts to make them more practical. FDA published its current thinking documents in 2000 that responded to many of our concerns, for example, by requiring diversion only upon a positive egg test and limiting the number of environmental tests.

We responded positively to the current thinking documents four years ago and we will honor that commitment today. The proposed rule, in its broad outlines, is faithful to the 2000 documents and we applaud the FDA for this consistency.

This does not mean, however, that we agree with everything in the proposed rule. Our members as well as scientific experts have expressed several concerns. These concerns do not call into question the value of quality assurance measures. The evidence is overwhelming that these measures can help us produce a safer product, but this proposed rule does raise some issues that need to be addressed.

I'd like to start with two broad thoughts about how the rule will be implemented and then some comments on a few scientific and technical issues.

First, the agency needs to make certain that this rule does not weaken, compromise or duplicate existing state and industry egg quality assurance programs. At least 15 states have official egg quality assurance programs. The CDC, as mentioned earlier, found a strong relationship between adoption of these plans and improvements in SE illnesses. With this proven track record, we cannot imagine that the FDA wants to weaken these existing plans.

We would suggest a recognition regime whereby FDA would review existing plans to determine whether they are equivalent to the FDA's own requirements. Compliance with a recognized plan would satisfy the producers' requirements under the proposed rule. An approach like this would reward success, honor federalism and minimize the new demands on FDA's own resources.

Secondly, we suggest that the FDA adopt a proposal that our organization has consistently made since the egg safety action plan was first announced. We believe that the FDA should streamline the regulatory process by utilizing state and federal agencies that already regulate the egg industry to carry out the inspections and enforcement of this rule.

The most obvious model is the Agricultural Marketing Service, which inspects all egg-packing facilities four times a year under the Egg Products Inspection Act. In many cases, the AMS uses state agencies for this program, often the same state agencies that are administering the state egg quality assurance programs. By using state and federal personnel who are already regulating the industry, FDA will avoid the need to hire and train additional personnel of its own.

We believe that this would be the most efficient and effective way for the FDA to achieve the annual inspection goal that is laid out in the rule's preamble, not to some of our technical or scientific uses we have.

First, can existing laboratories handle the significant increase in testing that will result from this rule?

Academic experts we have spoken to are not certain, partly because the agency has not specified exactly which labs can run the tests.

We also urge the agency to reconsider the sample size for egg testing. While 50 analysis [sic] may be statistically appropriate for a 100,000 birdhouse, a may be excessive and certainly extraordinarily expensive for a 10,000 bird flock.

Second, is 36 hours the right time for the rule's refrigeration requirements?

Eggs going into the retail market must be washed in a soap and water solution at a minimum temperature of 120 degrees Fahrenheit. When they are refrigerated beforehand, the temperature change during washing can be so severe that it causes the eggs to expand and crack. If this occurs, it will be detrimental to food safety, not helpful.

We believe that the agency should consider a longer period than 36 hours when making this rule.

Third, we believe that there should be positive incentives for producers to use vaccination, not as a substitute for other quality assurance measures, but as an adjunct. We are somewhat puzzled by the agency's lukewarm attitude toward vaccination, which has demonstrated success, not only here, but in the United Kingdom where it is an integral part of that nation's quality assurance program.

Fourth, we question whether wet cleaning will actually be helpful in reducing Salmonella Enteritidis. The FDA acknowledges conflicting science on this point and many of the experts we have consulted are alarmed by the wet cleaning requirement, because they believe that in field conditions, it may well cause a bloom of SE rather than a kill. When scientists are telling the agency that one of its control measures will actually make the situation worse, we believe the agency should take a second look.

Another issue here is geography. It may be almost physically impossible to wet clean during the winter in northern climates.

Fifth, are all the biosecurity measures outlined in the proposed rule warranted?

The industry recognizes that sound biosecurity measures are important, not only for food safety, but also for flock health, for example, to prevent the spread of avian influenza and exotic Newcastle disease. However, several scientists and producers are concerned that some of the measures suggested in the proposed rule are impractical and may have little positive impact on biosecurity.

Lastly, we urge the agency to provide indemnification for costs incurred by producers when eggs test positive for Salmonella Enteritidis and must be diverted. There is certainly precedent for this in legislation administered by the USDA, as directed toward the control of animal disease.

The egg industry has historically taken a very aggressive stance when food safety is involved. I want to assure the FDA that, while we believe the proposed shell egg safety rule is in need of some improvements, United Egg Producers is committed to working with you to maximize its benefits and make it as effective as possible.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you very much.

Next, Richard Wood, with FACT.

MR. WOOD: Thank you.

I am Richard Wood, the Executive Director of Food Animal Concerns Trust or FACT. FACT is a non-profit organization that advocates for better farming practices, to improve the safety of meat, milk and eggs. Over the years, as a consumer group, we have worked primarily with the FDA on feed safety and animal drug issues and the USDA on food-borne pathogen concerns.

It is a delight not to have to go to Washington, but rather, have you come here this time.

Also, for the last 20 years, FACT has worked with 14 smaller egg farms in Pennsylvania and in the Midwest, marketing eggs from uncaged hens to major grocery chains and developing that niche market.

Beginning in 1991, on our Pennsylvania farms, we included a control for Salmonella, a control program for Salmonella Enteritidis and we gathered extensive data on those tests and results over the years. By the way, even though those farms were smaller, only one of them was under 3,000, but they were still all small by today's standards.

We were a part when the egg safety proposal was first being discussed. We were a part of the discussions with the FDA and the egg industry and a coalition of consumer groups that arrived at a basic document. For FACT, two basic tenets are basic to this proposed rule.

First, FACT applauds the FDA for publishing a rule that is anchored in an assessment that accepts and understands the risks of Salmonella Enteritidis contamination and that recognizes where the first response must be, that being on the farm. This is by no means to point the finger only at the farm, but simply to acknowledge that any response must be a farm to table continuum if we want to together address food safety.

Second, we would like to underscore the importance of environmental testing as a central and important provision of this SE verification program. Environmental tests provide an accurate picture of whether or not the flock is contaminated. The tests must take place early enough so that if the eggs are positive, they will be diverted in time to pasteurization to protect public health.

Now, to some specific concerns that are different than what we addressed in Rockville and that are more focused on smaller productions, perhaps, than what has already been addressed here.

First, is the exemption of farms having fewer than 3,000 birds or farms that sell all products directly to consumers. As was pointed out in the proposed rule, there are approximately 65,000 small farms that produce about one percent of all the eggs consumed in the U. S. The large number of small farms creates, as we recognize it, challenge to the regulatory policy, because of the large number of resources that would be required to inspect these facilities. That was certainly reflected in the costs that were presented this morning, as compared to the benefits that would be gained from these inspections in terms of public health.

Also, from an egg producer's perspective, the burden of implementing a Salmonella control program may be higher for these small farms because they have fewer hens and fewer egg cartons over which to spread the costs, so the controls. At the same time, FACT believes that it is wrong for these farms to be completely outside the proposed program.

Mishandled eggs from a single small farm could easily result in an outbreak, affecting dozens of people. FACT proposes that the FDA require farms with less than 3,000 hens to follow a testing scheme, as described on page 56838, which merely lays out a protocol where small farms would test their flocks, but would not need to meet the other requirements of the proposed rule, unless positive environmental samples were found.

Adding on inspection of the small farms would probably not be necessary. Instead, the focus should be on educating small producers about the risks of Salmonella and the need for testing. In addition to the requirement that they do test, have one environmental test during each laying cycle of their flocks.

Secondly, while wanting small egg farmers to be included in the proposed regulation, we are concerned about the potential impact of this rule on free-range egg producers, which we feel should be covered under this rule, as we just described for smaller producers.

At FACT, our nest egg farms kept their hens indoors. Although they were uncaged and were a part of that niche market, we did have stringent biosecurity measures. Still, we support the marketing of eggs from free-range hens, hens that have access to outdoors. The USDA organic rule even requires outdoor access for laying hens.

[End tape 2, side 2 and begin tape 3, side 1, as follows.]

MR. WOOD: [In progress] --should be put in place to keep wild birds from nesting in laying buildings. But currently, in our review of the literature, there is a dearth of information on steps that free-range producers can take to lessen food safety risks. At this time, the risks of wild birds transmitting SE to free-range layers is speculative, rather than based on a range of research on that question.

Therefore, unless there is clear evidence that allowing outdoor access is a problem, the rule should not be written to preclude this type of egg production. As noted in the proposed rule, the necessary biosecurity measures should be tailored to an individual facility and this should include free-range facilities as well.

The bottom line is the environmental tests, which will confirm whether or not the biosecurity steps taken for a particular situation work, followed by if there is a positive environmental egg test and diversions to follow.

Third, FACT does not have anything to add to the debate on dry versus wet cleaning. I think the rule leaves that open as well. Wet cleaning was used on our nest egg farms in Pennsylvania. We would, however, like to suggest that you consider that a positive poultry house be required to conduct an environmental test after cleaning and disinfection if there is a positive.

On our Pennsylvania farms, we even went beyond that. We cleaned out after every flock, no matter if there was a positive or a negative. We rarely had a positive flock. And then we conducted an environmental test after the house was disinfected. In our sampling, we had one case after a wet clean out where a house was SE positive. In other testings of houses, although we didn't find SE, we did find numerous cases where we found other Salmonella serotypes, other than Enteritidis.

FACT believes that the extra step of testing a previously positive house after clean out and disinfection is necessary to protect new, incoming flocks from being infected. The cost of the environmental test would be much lower than the cost of diverting eggs if the subsequent flock becomes infected.

FACT would also recommend that FDA suggest, but not require that hens be vaccinated for SE if they are being placed in houses with prior environmental positives.

Finally, we support the proposed rule requiring environmental tests after molt, if that is the firm's procedure. We encourage the FDA and all stakeholders to review the current USDA SE risk assessment draft, which finds that a molted hen is more likely to lay SE infected eggs and that this is more likely to be present closer to a molt than at the 20-week time slot provided by this proposed rule.

Perhaps, an adjustment in the time for the test following molt needs to be made.

In conclusion, this proposed egg safety plan is a part of the continuum of food safety that truly begins on the farm. We commend the FDA for placing the initiating point for this plan where the concern begins. This plan then provides for a uniform, nationwide verification of the effectiveness of on-farm controls.

It creates a level playing field for, hopefully, all egg producers at some point and creates a level playing field of expectations for consumers. As consumers, we will know that, across the nation, wherever we buy our eggs, the farmer is taking these basic SE control steps.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you very much.

Next is Dr. Richard Dutton, Michael Foods.

DR. DUTTON: My name is Rich Dutton and I'm making comments for a number of people from Michael Foods as well.

Michael Foods Egg Products Company is, as Crystal Farms, M. G. Walbaum and Papetti's has gross sales in excess of $1.2 billion, of which 80 percent of the sales are in eggs and egg products. Fresh eggs account for approximately five percent, while pasteurized liquid, pre-cooked egg entries, hardboiled eggs, dried eggs and in-shell pasteurized eggs, frozen eggs and inedible animal products make up the remaining 95 percent.

As a company, we own approximately thirteen and a half million birds in our own facilities or as contracts and purchase eggs and liquid eggs from another 25 million birds. Our houses are predominantly ten percent high rise and 90 percent or maybe 95 percent belted-type housing.

The following comments are made from experiences since 1992 and really difficult to narrate in just a few minutes to provide any detail. However, comments will be submitted later.

Chick paper testing has resulted in isolations early and but nothing since 1993. The NPIP program is doing its part in monitoring breeder flocks. Commercial breeders have been responsible in testing and eliminating marginal farms and individual flocks that were troublesome. The result is full confidence in the NPIP program.

Pullet flock testing is independent of chick testing, however. Individual pullet houses or farms like layer farms have [unintell] characteristics of rodents, people, biosecurity and birds previously on the farm.

Single positive pullet houses have appeared in the middle of nine other houses and most of which have come from the same breeder flocks. In one case, a pullet house being positive at 12 weeks was rodent corrected and washed with the result that subsequent flocks were negative. Pullet house testing is independent and a necessary part of the program.

Refrigeration has proven an acceptable practice. However, in the breaking industry, contract producer eggs are moved to the plant at higher temperatures to increase the amount of egg white yield, improved peeling of hardcooked eggs and improved quality of pasteurized shell eggs. At 45 degrees, the rule of thumb is two percent loss of albumen, which will be attached to the shell and be lost as inedible.

Plants usually do not operate on weekends. So, the 36-hour rule will cause a loss in yield of stored eggs. An alternative program might be to allow temperatures above 65 or 60 for 72 hours, with a reduction, gradual reduction to seven days.

Those temperature conditions allow for the natural elevation of pH in the egg white, which is proven to improve shell removal after hardcooking and minimizes heat-induced cloudiness in whites of pasteurized shell eggs. These temperatures would be more applicable for eggs in transition and destined for processing, with a minimum negative impact on safety of pasteurized and hardcooked eggs.

Many contract producers do not have the ability to hold temperatures at 45, either due to inadequate space or equipment.

Testing of houses is a necessary practice to determine the presence and absence of SE. The methods need to be repeatable, simple and direct, using least cost methods. The published program costs two times more than older programs, primarily due to high numbers of single swab samples, added media and added laboratory labor.

The culture results may appear individually better, but in the grand scheme, the result is no better answer to the real question, which is whether SE is found in the house.

Identification of responsible person for a program is ideally good, but in a practical sense, many single person managed farms have time only to do the essential chores. Many of these farms are either contracted or marketed through a single processor having competent service people. Vertically integrated farms usually have designated technical people with a broad experience. Many states have voluntary programs that have been effectively servicing producers for many years.

Responsibilities need to be broadened to allow technical people to support the producer and not focus on producers alone, unless they have the time and experience to be involved.

Records are necessary to be kept on the farm. Excessive requirements and details for one person managed farms or large farms even will result in less well monitored programs in most cases. The goal is to reduce SE at the farm. The records required should be the culture results with an action to correct the problem. SE will be an ongoing problem, not correction at one point in time.

The many good voluntary egg safety programs should continue to be supported, since they provided service for the industry on a long term basis.

Cleaning and disinfecting of pullet houses is an acceptable practice, because the houses are usually smaller. Heat is readily available and down time between flocks in houses are built to manage water from washing.

Layer houses are not constructed to be wet cleaned. Basements may have manure in them. The producer is usually paid by the number of eggs going to the processor, which means the longer the down time, the less the income.

Winter conditions in the north prevent thorough washing, since birds, which are the source of heat, are gone. Water used in wet washing will freeze and drying takes several days, if not weeks. Plastic pipes freeze. Pipes shrink, become brittle, crack and break.

A number of years ago, a six-tier--we had a six-tier belted house that we decided was to be washed. The workers struggled day and night for nearly two weeks with high pressure sprayers and several employees. The result was probably a seven or $8,000 bill, a wet house, wet manure on the floor and a result not to do it again.

In another instances, three, four high belted houses on one farm that was found to be positive were dry cleaned, washed, disinfected by spray, fogged three times to the point of being SE culture negative. This project took several weeks. The costs were unacceptable, especially when the next flock was positive in 20 weeks. The following flock was vaccinated and no SE reoccurred.

In an inline complex, a single person manages more than one house by checking feeders, egg belts and pulling dead birds. The egg conveyor travels through all barns. Manure handlers will enter five to ten houses in a day. Mechanical and electrical people are moving between houses to correct problems. Tools and small equipment may be shared between houses.

The changing of clothes and shoes between barns is not beneficial. Foot baths between houses are not beneficial. One single house or separated house farms improve the ability to use some of these practices.

On the other hand, most complexes have dedicated equipment to the farm, for the farm. Equipment from the outside is restricted at the entrance to the farm. Visitors are restricted. Biosecurity for a complex is more effective at the outside gate.

Other comments.

SE in meat and bone meals, we have been monitoring for ten years and never found a positive SE. Pest and rodent control programs we believe are essential to reducing SE.

Vaccination is an acceptable alternative to washing and disinfecting houses when other biosecurity measures, such as, rodent programs are in place. We have managed a farm totally negative through an SE positive situation and back to negative again primarily with vaccination of the pullets and the layers that molt.

The cycle in any house includes the passage between two, primarily two hosts. That is the bird and the mouse. The reduction of one affects the other directly. Cats, people, flies, beetles and dust are a reflection of the level of environmental contamination, not a cause. The vaccination improves the protection of the egg, reduces the shedding in the bird, which reduces the number of organism available to the mice. Eventually, the mice die or reduce the shed of the organisms from the droppings.

Vaccination at molt has literally stopped the shed of SE and turned organism--excuse me--and turned the house to be environmentally negative. SE, phage eight and 13 have, in our conditions, been a labile organism. The organism is very well adapted to the specific intestinal environment and not well adapted to the outside environment.

When intestinal shedding is stopped for mice or birds, the environment will turn negative. Salmonella [unintell], for instance, has been recorded to remain in the environment for weeks to months, however.

A specific agency, such as, the AMS Group and voluntary programs need to be designated so that the industry has the ability to service and be serviced. SE is not a disease to be eradicated. It is a condition or exposure to be dealt with and will be for many years. There will continue to be successes and failures.

Not too long now, sorry.

The availability of breaking facilities to receive diverted eggs has been discussed many times. Egg processors are relying on plant--excuse me--egg processors are relying on planned production of shell eggs and have limited capacity to accept any significant diversions of eggs.

During the last five years, consumer pressure for further processed products of high quality have required processing plants to dedicate specific production to specific processing facilities. To insure both quantity and quality, inline breaking at the farms has increased.

A second question is the use of SE-positive eggs.

Consumers request egg products of specific quality and may not be receptive to accepting diverted eggs from known infected flocks. The industry is bound to comply by those requirements, even though it is established that pasteurization effectively results in safe products.

Safe egg programs for consumers should be federally mandated, including the use of pasteurized products, processed products in high risk areas, including hospitals and nursing facilities and better training and regulations at restaurants and catering businesses.

All producers, no matter the size, should begin the program at the same time. Many small producers or contracts are on a program already. It's a poke in the eye to the producers who have an SE program to allow two years to a small group of producers. An incentive for less than 3,000 bird producers should be developed to include them as part of the program as well. All egg producers will get blamed when a food problem occurs, no matter the size of the producer.

The most important part of the program should be testing, vaccination, where applicable, biosecurity, rodent control, practical records, responsible people or agencies and refrigeration.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you.

That is the end of the registered speakers. We now open up the floor for additional comments to be made.

[No response]

DEPUTY DIRECTOR CARSON: Okay, yes, sir?

MR. MACKLIN: I don't have any--this is Todd Macklin, with [unintell] Semi-Fresh Foods.

I don't have any written comments, but I'd like to support some of the things that I heard this morning from some of the people who just spoke, vaccination being one of them.

We definitely would support the use of vaccination and also provisions to use vaccination as an incentive. I believe, in the rule, it was listed as fairly expensive and maybe was one of the reasons why it wasn't encouraged more or more strongly supported. Actually, vaccination may prove to be less expensive when certain provisions or other things are changed within the rule that might provide more incentive, such as, reduced testing.

So, vaccination works. As scientists, we know it works. It has been proven all over the world and I think it needs to be more strongly supported in the rule.

I would also question the need for 45 degree storage for eggs that are going for processing, such as, an hardcooked egg operation. One of the reasons why eggs in this particular setting are stored at a higher temperature is in order for the pH to be increased. When the pH is increased to a higher level of the egg whites, it provides for much more peelability [sic]. Given the fact that these eggs are cooked to well over 170 degrees Fahrenheit, it would certainly support that they aren't necessarily or don't necessarily need to be store at 45 degrees Fahrenheit.

The 36-hour rule, I haven't spent a lot of time reading the articles that were referenced in that rule or in the proposal to require 36 hours for refrigeration as a maximum time, but the articles that were referenced in the rule and the ones that I have read so far, I can't see the support for a 36-hour rule.

We certainly know that Salmonella will grow extremely fast when it is inoculated into an egg, but one of the articles that was referenced cites a study that was done for naturally contaminated hens and, in fact, didn't show much growth of Salmonella at all up to about 21 days. So, I think the--I would suggest that the FDA look at those studies and support that 36-hour, if it's possible, to support that better with some of the science.

Finally, this is really about reducing food-borne illness, isn't it? So, I applaud the FDA for the work that they have done and for trying to make this more practical and more simple for the industry to implement. We would also support the adoption of the Model Food Code requirements for use of pasteurized eggs for high risk populations.

It just makes sense to me and in looking at Dr. Braden's presentation, if 11 percent of the outbreaks occurred in health institutions and if those are related to eggs, maybe you can clarify that. There is an 11 percent reduction right there maybe, for use of pasteurized eggs, which haven't been shown to be involved in any outbreaks. So, we would strongly support that as well.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you for that comment.

Are there any additional comments from the audience?

Yes, sir?

MR. THOMPSON: I'm Dave Thompson. I am an egg producer from northwest Illinois, also present on the Illinois Poultry Industry Council.

I support the comments of the Sparbo Company and Michael Foods and United Egg Producers. I'd just like to echo some of those things.

Basically, I am wondering why FDA has not proposed any mandatory steps at retailer food service. I think there should be--they should be included in the proposal.

I support the provision or the recommendations for AMS or an appropriate state agency to do the inspections.

I'm concerned, as a smaller producer, much smaller than the other people who spoke here, that we have some economical ways of testing to keep the costs down for our producers.

I would encourage FDA to include all egg producers, whether they are less than 3,000 or not as part of the program, because we are concerned, the Illinois Poultry Industry Council is concerned that, any infection in our flocks could cause a problem for the whole industry.

We support the provision that wet cleaning should not be required during the cold weather. We also feel like the regulation should promote vaccination for all producers. The 3,000 flocks should not be excluded from this.

I, again, feel like the FDA should support some sort of indemnity for producers that are required to divert eggs. I realize your comments earlier, when you were saying you don't have the provision to do that, but any producer who has to divert his eggs and is not--has to take an economic hit for that, should be provided with an indemnity.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you for your comments.

Any further comments from the audience?

MS. STRONGER: Pat Stronger with DayReg[ph] Foods. I would like to echo Dave's comments about supporting some of our co-industry or peer group here in terms of a lot of the topics they touched on. I'm going to try to keep my comments to, I think, one issue that we have not addressed here.

That is the timeline for the compliance once the proposal is finalized. I think the timeline is too restrictive really to be realistic. There are a lot of intricacies involved with moving from some control programs with pest control and insect control and clean out versus compliance with every detail of the regulation, as it is addressed right now.

For example, egg producers would need to find an SE negative supply of pullets. Right now, there is no requirement across the board for pullet growers to certify that their flocks are SE negative. And myself, as a layer producer, egg producer, I would certainly want to insist that I would be able to get a supply of negative pullets to house, if my expectations were to meet the FDA requirements for a SE negative flock.

Pullet growers will need a time to adapt to and comply with market demands as a result. Egg producers will need to look, you know, in addition, for the proof of the SE negative pullets. That proof would come via the pullet producers as well being able to train staffs and put documentation systems in place.

As an egg producer, we will need time to find and train employees to meet program needs and compliance issues. Farms will normally work on quite a skeleton staff and they may not be that person with the technical aptitude to be able to understand and comply with the regulations. So, that person will need to be able to be found and trained, as defined by the FDA. I understand that compliance training is not yet put together.

I have an issue with that as well in terms of once the proposal is out, we are going to put the curriculum for training together here, again, in a time strapped industry. This is not going to be acceptable for the producers.

If we continue to--if we must have the hundred percent manure removal regardless of the time of year for positive flocks, we are going to need to find alternative storage for that manure until it can be land-applied. There are some very severe environmental issues associated with the improper handling of waste products. Producers are very concerned about this.

Storage buildings, if necessary, can cause thousands if not hundreds of thousands of dollars to put up and to maintain. For an already cash-strapped industry, that is going to be a huge burden, especially for the producers when the market will most likely be depressed as a result of more eggs being diverted into the breaking market. The farmers will be selling eggs into a diversion market at suppressed prices and have additional costs to be borne as a result of the program.

So, in conclusion, I would just like to say that I think, here again, the timeline for compliance, I think, should be extended at least double to be more realistic and not have probably a detrimental, hugely detrimental impact to the farmers.

DEPUTY DIRECTOR CARSON: Thank you for that comment.

Any additional comments from the audience?

[No response]

 

[Closing Remarks/Adjournment]

DEPUTY DIRECTOR CARSON: Okay, I want to thank you for your attention today. Again, we are accepting public comments until December 21st of this year. We do appreciate all the comments made here today and appreciate your contributions.

Thank you very much.

[Applause]

[Whereupon, the proceedings in the aforementioned matter were concluded.]