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Public Meeting on "Proposed Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production - November 2004

 

November 16, 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. CDC SE Human Illness/Outbreak Presentation
    Michael Lynch, M.D., MPH, Medical Epidemiologist, Food-Borne and Diarrheal Diseases Branch, National Center for Infectious Diseases, Centers for Disease Control and Prevention
  4. Presentation of FDA's Proposed Rule
    Nancy Bufano, Office of Plant and Dairy Foods, Division of Dairy and Egg Safety, FDA/CFSAN
  5. FDA and CDC Panel: Stakeholders' Questions and Answers
    1. Question by audience member
    2. Greg Cutler, Cutler Associates
    3. David Castellan, California Department of Food and Agriculture
    4. Hyal Kinde[ph], California Health and Food Safety Laboratory
    5. Pat Curtis, Auburn University
    6. Don Bell, University of California
  6. Stakeholders' Public Statements
    1. Douglas Kuney, Area Poultry Farm Advisor, UC Cooperative Extension
    2. Richard Breitmeyer, California Department of Food and Agriculture
    3. David Castellan, California Department of Food and Agriculture
    4. Nancy Rheimer, Cutler Associates
    5. Greg Cutler, Cutler Associates
    6. Danny O'Day, VP of California Operations, Valley Fresh Foods, Inc
    7. Tom Silva, Egg Producer and VP, West and Company, Modesto, CA
    8. Ralph Erstin, Retired Poultry Specialist, University of CA
    9. Don Bell, University of California, Retired Poultry Specialist
    10. Debbie Murdoch, Pacific Egg and Poultry Association
    11. Craig Willard[ph], President, Norco Ranch, Inc
    12. Mark Oldenkamp, VP of Operations, Valley Fresh Foods, Inc
  7. Closing Remarks/Adjournment
    Louis Carson, FDA

Proceedings

 [Welcome and Introduction]

DEPUTY DIRECTOR CARSON: [In progress] --Deputy Director of the Food Safety and Security Staff, at the Center for Food Safety and Applied Nutrition.

I want to welcome you here to the third of our three public meetings on the proposed rule for prevention of Salmonella Enteritidis in shell eggs during production.

Each one of you should have picked up a folder that will have some material in it. What is in the folder is, first, an agenda and I will be going through that briefly here to start. We will have two slide presentations and the slides are contained in the folder on the righthand side, I believe.

In addition, there are--on the left side are FDA's press release on the rule and then two documents. One is a FAQ sheet. The next is a method for the detection of Salmonella Enteritidis in environmental samples from poultry houses. So, that is some background information and documentation for you.

I'd like to go briefly over the agenda and how we are going to be running the meeting today. The meeting is being taped. So, I ask each one of you as you wish to make a comment or pose a question, that you go to the microphone and please give your name and affiliation so that can be captured by the taping. Once we have the tape, we will then transcribe that tape. The entire meeting's minutes will be put on the website roughly a month after the meeting here. It takes about that long for it to be completed.

So, this morning, I will first go through some overview points. We will have a short tape by our Acting Commissioner, Dr. Lester Crawford. Then we will have two presentations, one by Dr. Michael Lynch, who is replacing Dr. Chris Braden. He is a medical epidemiologist at the CDC. He will be talking a bit about the CDC SE illness estimates and how we derive that and how those estimates are used as a baseline in our proposed rule.

Second, Ms. Nancy Bufano, who is a consumer safety officer with us in the Center for Food Safety and Applied Nutrition, in the Office of Plant and Dairy Foods, will make a presentation about the components of the rule itself.

Following those two presentations, we will then have a panel session that will include Dr. Brad Brown, who is an economist, again, within the Center for Food Safety and Applied Nutrition to take any questions for clarification from the presentation or clarifying parts of the rule that you may ask a question about. That is not the period at which you should make comments. We will have a full period following the break for each one of you to make comments.

We have a list of registered speakers for comments, which I will announce each one of those to make a presentation five minutes in length and no more. Then following all of those who have registered, I will open it up to the audience if others would like to comment. Again, I would ask you to go up to the microphone, give your name, affiliation and then your comment.

Again, we are in the proposed rule phase. So, FDA is obliged to not respond to comments here today. We can only respond to clarify issues that are not clear or, perhaps, a definition is not well stated and we need to restate it for you. We cannot make comments on changes or alternatives you may offer today. Those are for the public record and those are for us to consider, as we consider the final rule.

So, we do encourage you to make those comments but, again, please be aware that we are not able to respond directly to comments such as that, at this point in time.

As I mentioned, FDA published a proposed rule on egg safety on September 22nd. It is open for a 90-day comment period, closing December 21st. So, I encourage each and every one of you to submit your comments either in writing or electronically to FDA's docket.

As I mentioned, this is the third of three public meetings. We held one on October 28th, in College Park, just last week, in Chicago, Illinois and now here, in Los Angeles.

Again, in this proposed rule, FDA is announcing a program that would require egg safety measures on the farm. It is one step of an overall program that includes two other rules that we published in 2000. Those two other rules were the egg labeling and handling statements on egg cartons and refrigerated storage at retail. We believe all three rules together will achieve the 50 percent reduction of SE illnesses that we are putting forward as our goal by the year 2010.

As I mentioned, we will have two presentations to start with to explain our baseline illness data and Dr. Lynch will be presenting that. Then Ms. Bufano will be presenting the specifics of the rule and how we derived that.

Basically, the proposed rule has on-farm steps, but within the rule, we have asked a number of questions for commenters concerning additional steps FDA should take. At the previous meetings, people have commented about retail measures and we do have in the proposed rule where we do ask specific questions about specific retail measures that we may or may not take as part of the mandatory rules. So, I do ask you to direct your attention to those and to make comments appropriate to those, if you believe they are appropriate.

Secondly, there have been questions concerning the economics of the proposed rule and, I believe, we have extensively explained those in the rule, but we are here again to respond to specific questions of how those things were derived. Dr. Brown or others may be here to try and respond to those kinds of questions.

With that, I believe I would like to now cue up the short presentation of Dr. Lester Crawford that would open this meeting. Then we will come back to the presentations.

 [Opening Remarks]

[Videotape of Dr. Lester Crawford, Acting Commissioner shown.]

DR. 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 is 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 was not fully cooked, you could suffer symptoms ranging from mild to severe gastrointestinal 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 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, biosecurity, 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.

DEPUTY DIRECTOR CARSON: Again, thank you, Dr. Crawford.

Next on the agenda is Dr. Michael Lynch, who is going to speak to you about the CDC SE human illness outbreak data. Again this presentation is in your folders so you can follow along there.

Dr. Lynch.

[Pause]

 [CDC SE Human Illness/Outbreak Presentation]

DR. LYNCH: Good morning.

I'd like to start by defining a few terms. These may be familiar to many of you in the audience. Salmonella Enteritidis is the bacteria, Salmonella Enterica, serotype Enteritidis or what we refer to often in the slides as SE. A serotype is a subcategory of Salmonella, based on reactions with specific antibodies.

Salmonellosis is the term we use for the disease caused by Salmonella Enterica and isolate is a Salmonella bacterium obtained from a single laboratory culture.

Today, I'm going to be speaking about two types of surveillance for Salmonellosis in the United States, surveillance for individual patients and surveillance for outbreaks. For individual patients, Salmonellosis is a nationally reportable disease. All 50 states and territories report their cases to the CDC. States have laws which require Salmonellosis case reports from clinicians and laboratories. States, in turn, voluntarily report their cases to CDC.

Outbreaks are defined as two or more people becoming ill due to a common food exposure. Outbreaks may be reported to local health departments by citizens or clinicians or they may be recognized by the health department as a cluster of reported individual patients.

Once outbreaks have been recognized and investigated by local health departments, they are reported to CDC as well.

The first surveillance system I will describe is the National Salmonella Surveillance System, which was started in 1963 as a paper-based, aggregate report of the number of Salmonella cases identified in each state. In 1980, the Public Health Laboratory Information System was implemented at CDC. It is an electronic system for collection of Salmonella isolate data by serotype. It is based on the number of Salmonella isolates identified or received at public health laboratories in each state.

This is a graph of the top four serotypes of Salmonella, reported through the National Salmonella Surveillance System since 1970. Salmonella Typhimurium is represented by the magenta line, Enteritidis by the blue line, Heidelberg by the yellow line and Newport by the green line.

Note that there is a large peak of Salmonella Typhimurium cases in 1985. This was due to a very large outbreak due to milk. I'm going to remove that peak in order to see the trends better.

Originally Salmonella serotype Typhimurim had been the predominant serotype in the United States. However starting in the mid-1980s, Salmonella Enteritidis began to increase in incidence to the point that it became the most prevalent serotype in 1994. Since then Salmonella Typhimurim and Enteritidis have had similar incidence.

If we stretch out the time period, 1989 to 2002, we see the peak incidence of Salmonella Enteritidis is in 1996, with 10,201 cases. Since then, it has decreased by half to 5,116, though over the period 1990 to 2002, it did not decrease appreciably.

The rates of Salmonella Enteritidis by region of the country have been very different. The Y axis on this graph is the number of reported cases per 100,000 population or instance rate. The X axis represents years. The green line represents the New England states, which were the first to show an increase in cases of SE in the late 1970s.

By the mid-1980s, the mid-Atlantic states had rapidly increased the number of cases, followed thereafter by a western spread to include increases in the Pacific and Mountain regions of the country. All of these regions have had decreases since 1996.

The CDC surveillance system I will describe is called FoodNet. FoodNet is a network of selected state public health laboratories in the United States, which participate in conducting active surveillance, surveys in epidemiologic studies. By active surveillance, I mean that the health departments review laboratory records at hospitals and other clinical laboratories for instances of Salmonella isolates.

FoodNet conducts surveillance for the bacterial food-borne pathogens Salmonella serotype, Shigella species, Listeria Monocytogenes, E. Coli serotype 0157:H7, Campylobactor species, vibrio species and yersinia species.

In 1996, FoodNet began surveillance in five state health departments, Minnesota, Oregon and selected counties in California, Connecticut and Georgia. During this initial year of surveillance, there were 14.3 million persons in the FoodNet catchment area. In 2003, there are ten state health departments, which participate in FoodNet, with 36 million persons in the catchment area or 13 percent of the U. S. population.

This is a graph comparing relative rates of laboratory-diagnosed SE cases in FoodNet sites from 1996 to 2002. Again, we are talking about rates and comparing rates over time to a baseline rate.

The rate in 1996 is the baseline or reference rate. There was a decreased rate in 1998 and then an increase for the near return to baseline in 2002. This mirrors the curve of counts for the entire U. S., shown earlier for 1996 to 2000. That increases slightly in 2001 and 2002.

From our experience with laboratory-based surveillance, we know we do not count every case of illness that occurs. We know that each laboratory-confirmed case represents many more cases. We think of this as a pyramid.

For each case of illness, several things have to happen for a culture-confirmed case to be counted in surveillance. The person must seek care for their illness. A specimen must be obtained. The lab must run a test for the organism we are interested in and the result must be reported to the health department and then to CDC.

FoodNet activities have helped to fill in many levels of this surveillance pyramid. Population surveys of health care seeking behavior establish what proportion of ill persons will seek care for a particular illness.

Physician surveys tell us what proportion of physicians order lab tests for particular conditions. Laboratory surveys identify what proportion of laboratories test for and recover particular organisms. Active surveillance helps insure that culture-confirmed cases are reported to the health department and to CDC.

Using this information, we can estimate the total number of cases of SE in the United States in a given year. In 2002, 5,116 cases were reported.

From FoodNet surveys, we estimate that for every case of Salmonella infection reported, 38 go unreported. If you multiply 5,116 by 38, we get 194,408 estimated cases of SE in the United States in 2002.

A plausible range of values can be determined for the multiplier that we used. For Salmonella, it is 23:65, which would give, obviously, different totals for the estimated number of cases.

I will move on to talk about SE outbreak surveillance.

CDC surveillance of food-borne disease outbreaks began in 1973, with the collection of paper forms from state and local health departments, reporting information gathered during investigations of food-borne outbreaks. The reporting forms in the system were enhanced in 1998. More active surveillance of outbreaks was started, which involved CDC staff contacting states on a regular basis about outbreaks.

Our current Electronic Food-Borne Outbreak Reporting System or EFORS was implemented in 2001. With EFORS, reporting of food-borne outbreaks is done electronically by states.

This graph shows outbreaks reported to CDC's Food-Borne Outbreak Reporting System, from 1990 through March of 2003. Reports shown in blue represent those captured by our paper-based reporting system. Those in pink are those received after we changed our surveillance system.

The sharp increase in reports shown by the pink bars, follows the improvements or surveillance system previously mentioned. This increase should not be misinterpreted as a true increase in the number of outbreaks but, rather, an improvement in the surveillance for these outbreaks.

The number of outbreaks due to SE, however, decreased during this same period, from over 80 in 1990 to 29 in 2002.

We can also look at the SE outbreaks as a percentage of all reported outbreaks. From 1990 to 2002, the percentage of all food-borne outbreaks due to SE decreased. This makes sense, as we know from the two previous slides that, the total number of outbreaks increased, while the number of outbreaks due to SE decreased.

The number of cases of illness associated with SE outbreaks decreased a little during this time period. There were fewer outbreaks, but there were some of larger size. The spike in outbreak- associated cases in 1994 was due to one particularly large outbreak that year.

Shown here are outbreaks of SE by location of food preparation. Food preparation for the majority of SE outbreaks has been at commercial venues, such as, restaurants, delis, bakeries.

One of the interesting things we learned from outbreak investigations is the food vehicle associated with the infection. From 1995 to 2002, there were 960 SE outbreaks reported to CDC. The food vehicle was determined in 413 or 45 percent of these. We were able to determine that the food vehicle contained eggs in 413 of these outbreaks; 326 or 79 percent of those outbreaks were egg-associated.

Similarly, there were 32,338 cases reported from reported SE outbreaks; 23,077 cases associated with outbreaks where a food vehicle was determined and 17,413 cases in outbreaks that were determined to be egg-associated.

This slide is looking at the same data by year. The number of outbreaks associated with egg-containing food vehicles is shown in yellow. It is fairly consistent over time, with a slight decrease in the mid-'90s to 2002. The 2003 data here are preliminary.

We can also look at the types of egg-associated food vehicles implicated in SE outbreaks. Eggs or egg-battered food vehicles constitute the largest percentage, followed by desserts, sauces, pasta and others.

Determining an association between SE illness and eggs is done predominantly through a food-borne outbreak investigation. Although the association between SE eggs has been recognized for some time, food-borne outbreak investigations are conducted by generating multiple hypotheses and statistically testing them to see if there is an association.

Investigations of SE outbreaks does not involve just looking for eggs. In fact, SE has been associated with other foods, notably turkey, chicken, almonds. When trace back investigations are conclusive, SE of the same subtype is often identified on the farms of origin of the eggs.

We just looked at the proportion of outbreaks, the number of cases in outbreaks that are associated with eggs. What can we say about attributing egg association to all SE cases, including those that are not part of outbreaks?

There is uncertainty in both what we can say about outbreak-associated cases and non-outbreak associated cases. As was shown, only half of all SE outbreaks have a food vehicle identified. We don't know for sure if the outbreaks where a food vehicle is determined are similar to those where one is not.

The majority of SE cases are not associated with an outbreak. Again, we cannot be sure that they are from the same cause as cases associated with outbreaks. But our working assumption is that they are similar.

To attribute egg association to all cases, we can look at a high range estimate and a low range estimate of the proportion of SE cases associated with eggs. The range estimate we saw a few slides ago, 79 percent of SE outbreaks where a vehicle is determined are associated with eggs.

The low range estimate is determined by looking at the proportion of cases in egg-associated outbreaks as a percentage of all SE outbreaks, not just outbreaks where a food vehicle is identified. If we do that, we find that 53 percent of cases in all SE outbreaks are cases and outbreaks that are egg-associated.

The mid-range estimate is the mean of the high and low estimates or 66 percent. We use this percentage in our calculations of the estimated number of SE cases due to eggs.

So, from these data, we can estimate the number of SE cases due to eggs in the United States We take the number of reported cases, 5,614, use the FoodNet multiplier of 38, which accounts for the number of cases that go unreported and we subtract the estimate proportion of cases acquired outside the United States. We use the mid-range estimate of 66 percent of SE cases due to eggs.

To go through the calculations, we multiply the number of reported cases by the FoodNet multiplier and get 213,332 total estimated cases. We subtract out the proportion acquired abroad, the 16 percent and get 179,200. We multiply this by the mid-range estimate of cases, the proportion of cases due to eggs or 66 percent, to get 118,270. We round this to 118,000.

This number is used in the FDA SE proposed rule and will be used to follow the impact of regulations. As mentioned by Dr. Crawford, the goal is to reduce the number of cases by 50 percent.

This graphic is designed to show changes in the instances of Salmonella Enteritidis in states that adopted voluntary egg quality assurance programs. On the X axis are the years before and then after the adoption of quality assurance programs, with the middle, vertical, dotted line being the year of adoption.

On the Y axis is the annualized percent change in SE incidence relative to the EQAP adoption.

The horizontal line indicates zero percent change. Anything above the vertical line indicates an annual increase. Anything below the horizontal line indicates an annual decrease.

We examined first the changes for the group of four states that had, at least, a five-year experience with EQAPs. You can see that there was a relative decrease in the incidence of SE cases in the years after adoption.

There are six states that had at least a three-year experience with EQAPs, seven states that had a two-year experience and 11 states that had at least a one-year experience.

The Y axis shows whether SE incidence was increasing or decreasing relative to the year zero. For the group of four states who had at least a five-year experience, SE incidence increased by about ten percent per year. As you can see, it was increasing in the years before EQAPs were adopted.

In all categories of states, the incidence decreased after EQAPs were adopted.

In conclusion, nationwide, there has been a decline in SE cases since 1996, but less so in recent years. There has not been a significant change in the rate of SE in FoodNet states, comparing 1996 to 2002.

There has been an important decline in outbreaks, although a significant number of outbreaks continue to occur. Control programs are making progress, but need to be widely adopted.

Thank you.

[Pause]

DEPUTY DIRECTOR CARSON: Thank you, Dr. Lynch.

Again, hold your questions for clarification until we have the next presentation.

 [Presentation of FDA's Proposed Rule]

Next, is Ms. Nancy Bufano, Consumer Safety Officer within the Center for Food Safety and Applied Nutrition, who will talk in-depth about our propose rule.

Nancy.

[Pause]

MS. BUFANO: Good morning.

I'm going to give an overview or a little bit of background about the rule and overview. I will go through the provisions in-depth. I will talk a little bit about the economic analysis -- the costs and benefits -- and then specifically where FDA is seeking comment on the rule.

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

As you learned from Dr. Lynch's presentation, eggs are a major cause of food-borne illness. From 1993 to 2000, an average of 80 percent of source-confirmed SE outbreaks were egg-associated and eggs cause approximately 118,000 SE illnesses a year.

We believe the best way to prevent these SE illnesses is at the farm level.

Our approach to this proposed rule was developed with input from both industry and consumer groups. Many of you probably remember four years ago when we did public meetings across the country to gain input and comments from our stakeholders on how the proposed rule should look. We used that input. We used those comments and we look forward to your continued input, as we move forward with the final rule.

Our proposed requirements have already been tested at the state level. As you saw again in Dr. Lynch's presentation, the egg quality assurance programs, our proposal uses many of the same on-farm prevention measures and we know that these measures work.

The benefits are $580 million and just over 33,000 illnesses avoided annually, at a cost, a total cost of $90 million annually. The health outcomes can be clearly measured. We can clearly measure the decrease in SE illnesses.

From the very onset, we used a risk management, risk assessment approach. In 1998, USDA and FDA conducted and published a joint risk assessment on SE in eggs. The risk assessment analyzed each step in the farm-to-table continuum, egg continuum to determine the relative risks at each step, the relative risks that each step contributed to SE contamination of eggs.

It revealed that preventive measures can be taken at each step in order to maximize human health benefit. The most effective preventive measures that can be taken is to prevent SE on the farm, to prevent the eggs from being contaminated in the first place.

We do know that some infection is unavoidable, so refrigeration throughout the food chain will stop the bacteria from multiplying. We know that pasteurization and thorough cooking kill the bacteria, which is why we require a treatment or pasteurization for eggs that are found to be SE-positive on the farm and why we continue with our ongoing education for consumers and retail establishments for thorough cooking.

We will talk specifically about what the regulation says and, first of all, who is covered. You would be covered by all the requirements in the proposal if you--and this should say if you have 3,000 layers or more, not more than 3,000 layers. So, you are covered by all the requirements if you have 3,000 layers or more, you do not sell all of your eggs directly to consumers and any of your eggs are not treated.

I will define treatment in the next slide.

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

So, you are not covered by the rule at all, you would be completely exempted if you have fewer than 3,000 layers and/or you sell all of your eggs directly to consumers, like a roadside stand.

In the proposed rule, treatment is defined as a technology or a process that achieves at least a five-log destruction of SE or the processing of egg products in accordance with the Egg Products Inspection Act.

The five SE prevention measures outlined in the rule are SE-free chicks, biosecurity, rodent and pest control, 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 eggs produced on that farm.

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

The biosecurity outlined in the proposed rule applies to the grounds and all the facilities and seeks to reduce SE from environmental, personal and animal contact. The proposed rule requires that you limit visitors on your farm and in your houses; that you restrict movement of equipment between houses, so it is not a source of SE; that you restrict persons moving between 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 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, therefore, 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 populations of rodents and pests, using appropriate monitoring methods and then if necessary, use an appropriate method to decrease those populations and that you remove debris within houses and vegetation and debris around houses that may harbor pests.

Cleaning and disinfection of houses in the proposed rule would only be required at depopulation or really prior to repopulation, when either the house or the eggs in that house have tested positive for SE.

The cleaning and disinfection proposed in the rule is to remove all visible manure, to dry clean, to wet clean and then to disinfect, using appropriate disinfectants.

Refrigeration has been shown to minimize the growth of SE that might be present in eggs. So, for that reason, the rule proposes that if eggs are held on the farm for 36 hours or more after lay, that they be refrigerated at an ambient temperature of 45 degrees Fahrenheit or less. This provision would apply to all eggs regardless of whether or not they are going to receive a treatment, whether they are going to egg products, whether they are going to an in-shell pasteurization or whether they are going to the table market.

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

If you do induce molting, you are also required to conduct an environmental test at approximately 20 weeks after each molt. If that environmental test is positive, it is the same requirements as before. You review and make adjustments to your SE prevention methods and either begin egg testing within 24 hours or divert all the eggs from the positive house to a treatment for the life of the flock in the house.

Egg testing is only required if you have a positive environmental test. I have a flow chart in the next slide, which I think explains this better. I will go through it first.

Each test, each egg test consists of a thousand randomly collected eggs from one day's production. Four tests are required at two-week intervals and if all the tests are negative, you are not required to do any further egg testing.

If any of those four tests are positive, you must divert all the eggs from that house until four tests at two-week intervals are negative. Once four tests at two-week intervals are negative, you must still conduct one test per month for the life of the flock. That is because you did have a positive in there at some point.

If any of the monthly tests are positive, again, you must divert all the eggs until four tests at two-week intervals are negative.

This is the flow chart. I don't think we have a pointer, do we?

It is pretty self-explanatory. You start on the far left, where it says "start" in the little diamond. Your first thousand-egg test, if that is positive, you are required to divert. If you want to continue to produce eggs for the table egg market, that is when you are required to go back and start again with the thousand-egg test.

Now, you can just divert for the life of the flock in that house and not do any further egg testing.

If that first thousand-egg test is negative, you wait two weeks; do another thousand-egg test. If it is the same thing, if it is positive, you are required to divert and begin again, with a 1,000 egg test, that is, if you want to go back into table egg production.

If the second test is negative, you wait two weeks; do a third test. If it is the same thing, if it is positive, you have to divert, start over again with a thousand-egg test. If the third test is negative, again, wait two weeks and do a fourth test. If that fourth test is negative and you never had any positives, in other words, all four have been negative, you are not required to do any further testing for the life of that flock in that house.

If you do get a negative on that fourth thousand-egg test, but you did have a positive before, in other words, it's maybe your second or third time through, you are required to conduct one test per month, one egg test per month for the life of the flock. If any of those egg tests are positive, again, you have to divert immediately. If you want to go back into table egg production, you have to start again with the thousand-egg test, the four thousand-egg tests at two week intervals.

The methodology required for the environmental sampling - the rule states you must use a scientifically valid sampling procedure. It discusses two environmental drag swab sampling methods. But it also requests comments and data on drag swabbing methods and alternative methods for sampling that might be more uniform than drag swabbing, such as, air sampling.

We will consider the comments we receive and determine what method will be required in the final rule.

The testing methodology for the environmental samples is Detection of Salmonella in Environmental Samples from Poultry Houses or an equivalent method. That method is available on our website. I believe it is also in the packet you received today.

For egg samples, it is the pre-enrichment method published in the "Journal of Food Protection" or an equivalent method.

Administration of the SE prevention measures on the farm - the rule requires that you have one individual at each farm who is responsible for administration of the SE prevention measures. That individual must have completed training--I'll talk in just a minute about training--or have job experience that is equivalent to training.

Their responsibilities include developing and implementing the SE prevention measures, reassessing and modifing the measures as necessary and reviewing records.

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

MS. BUFANO: Guidance and training - we plan to publish guidance on the standards for each provision and per our good guidance principles, each guidance will be published for comment prior to implementation. We plan to publish draft guidance, probably around the same time that the final rule publishes. The final rule will obviously have an implementation period. During that implementation period, we will get comments on the draft guidance. So, the final guidance will be published before the rule actually must be implemented.

Training - we plan to train both industry and government, using an alliance with industry on the best practices in how to implement the rule, similar what we have done with juice HACCP and seafood HACCP.

There is a small business provision in the rule. Small farms with--this should be fewer than 3,000 layers--are exempted from all provisions. We do seek comment on the appropriateness of this exemption. This provision reduces the cost of the rule by $40 million. It allows for fewer than 200 additional illnesses.

How do we know that on-farm prevention measures work?

We know they work from specific states' experiences and the regional shifts in illnesses once controls were put in place. Dr. Lynch's slide was even more convincing. The one we have here just tracks SE outbreaks regionally for the 15-year period from '85 to 2000. You can see, the pink line shows the dramatic decrease in SE outbreaks in the northeast after 1992, when Pennsylvania implemented their egg quality assurance program.

The goal of the egg safety program is outcome-based, as you have heard earlier this morning. The current goal is to achieve at least a 50 percent reduction in egg-associate SE illnesses by the year 2010, and we are incorporating this goal into the Healthy People 2010 Initiative.

I'll talk a little bit now about the economic analysis.

The major benefits from this rule come from preventing severe, acute cases of SE illnesses and deaths and from preventing reactive arthritis as a chronic complication of acute illnesses. The major costs of the rule come from pest control and biosecurity, refrigeration, testing and diversion and records.

I talked about the small business exemption. Farms with fewer than 3,000 layers are exempt from all the provisions and it is important to note that most layer farms are small businesses.

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

The cost savings to Medicare and Medicaid for reduced medical costs is approximately $4 million.

The annual cost to the industry is estimated to be $82 million. We estimate that 4100 farms will be affected by this rule when it is finalized. That is based on the following breakdown. Just over 2300 farms with 3,000 to less than 20,000 layers, 950 farms with 20,000 to less than 50,000 layers, 350 farms with 50,000 to less than 100,000 layers and 450 farms that have more than 100,000 layers.

Annual costs to the government, these are based on 4100 farms or, to us, that is 4100 inspection sites. FDA will inspect and enforce with state and other federal agency partnerships. It is important to note that, FDA is the sole enforcer of the rule, but we may use--we anticipate using state and other federal agencies to help us in implementing and inspecting.

We phase it in over two to three years. The expected annual cost to the government is $8 million, based on the cost of state contracts, audits, lab testing, training, outreach for industry and also for FDA.

To summarize the economic analysis, the benefits are exceptionally high because of the present value of future reactive arthritis costs are prevented. Certainly, analysis shows that even at low levels, benefits are still much higher than the estimated costs.

Request for comments - we do, as you are reading through the proposal, you will notice that we request comments, seek input in many, many areas in the preamble. Something like 25 different times, we ask for comments.

There are three major areas where we are seeking input, measures for at-risk populations, registration and recordkeeping.

The measures for at-risk populations - the current 2001 FDA Model Food Code contains several provisions that are specific for institutions that serve highly susceptible populations. So, we are talking about hospitals and nursing homes and daycare centers and the like. We are asking if that alone - the fact that those specific egg handling, special egg handling provisions are in the Food Code for those institutions and the fact that states adopt the Food Code and then implement it and enforce it - is that adequate to achieve our public health outcome goals, or do we need mandatory federal standards for those institutions?

If you believe we need mandatory federal standards, how would those standards be best implemented and, specifically, which of the provisions in the 2001 Food Code should be mandated for those retail establishments that specifically serve highly susceptible populations? So, that is a big area for comment.

Also, registration. Should FDA require egg producers to register the name and location of their business with FDA?

It is important to note that farms are exempted from registering with FDA under the interim rule on registration we published under the Bio-Terrorism Act. That rule requires that all food production facilities must register with FDA, but farms are specifically exempted.

The last main area in our request for comments is recordkeeping. Should we expand the recordkeeping provisions to include the following: establishment and maintenance of a written SE prevention plan and maintenance of records indicating performance and compliance in implementing the 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, to consult with industry, states, federal partners and consumers and to use lessons learned and steps from existing egg quality assurance programs.

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

In enforcing the rule, again, it is important to note that, FDA is the sole enforcer of the rule. We are considering contracts with states and federal partners to assist us in our inspection and implementation efforts.

Again, we are seeking stakeholder comments, which is why we have had these three public meetings. The comments--it is a 90-day comment period, ending December 21st.

In conclusion, we expect that 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.

DEPUTY DIRECTOR CARSON: Thank you, Nancy.

 [FDA and CDC Panel: Stakeholders' Questions and Answers]

Now, we will entertain questions for clarification of any of the presentations or questions on clarification of the rule. If you have a question, I please ask you to go up to the microphone; state your name and affiliation and then ask your question. I would ask that you hold comments until the comment period.

So, are there any questions at this time?

Please go to the microphone.

QUESTION: Hi, I am [unintell]. I'm from Los Angeles County Department of Health Services.

My first question is for Dr. Lynch. I was just wondering how did you get the data on the proportion of cases acquired outside of the U.S.?

DR. LYNCH: That is from FoodNet surveys.

QUESTION: And specifically for SE, cases of SE or just in--

DR. LYNCH: You know, to be honest, I don't remember if that is for all Salmonella. I believe it is for all--I don't know if it's for all Salmonella or just for SE.

QUESTION: Okay.

Is there a reference; has that been published yet or you're not sure?

DR. LYNCH: Not that I'm aware of.

QUESTION: Okay.

I was also wondering if in FoodNet, since they hadn't noticed a significant change in rate of SE, that's just since 1996 when FoodNet started?

DR. LYNCH: Correct, it is comparing 1996 to 2002. You saw the one slide. There was a decrease in the late '90s and then it--

QUESTION: But it's just not enough to be significant statistically?

DR. LYNCH: Correct.

QUESTION: For Nancy Bufano, I had a question. Let's see.

[Pause]

QUESTION: Oh, do you know what the proportion is of egg production by the smaller farms, the less than 3,000?

MR. CARSON: Less than 3,000, it is less than one percent.

QUESTION: Okay.

Also, is there a reference for your health care cost estimates?

DR. BROWN: It's--

DEPUTY DIRECTOR CARSON: Speak into the microphone.

DR. BROWN: Yeah, I'll look that up for you. It's going to take--

QUESTION: Thank you.

DR. BROWN: --me a minute to find it. It's in the rule.

DEPUTY DIRECTOR CARSON: It is in the rule. We will look it up and get back to you.

QUESTION: Oh, thank you.

DEPUTY DIRECTOR CARSON: Are there any other questions?

Yes, sir.

MR. CUTLER: Greg Cutler, Cutler Associates.

I wonder if Nancy Bufano would review one more time the order of events if an environmental positive is found. I'm not sure I'm clear on that.

DEPUTY DIRECTOR CARSON: Sure.

MS. BUFANO: Specifically the egg testing, right?

MR. CUTLER: Yes.

[Pause]

MS. BUFANO: Are you talking about this slide?

It would be great if I had a pointer.

You just want me to go through it again? Did you have a specific--?

MR. CUTLER: Specifically, you find an environmental positive. Within 24 hours, you are required to do egg testing.

MS. BUFANO: Correct.

MR. CUTLER: If that first test is negative, what is the next step?

MS. BUFANO: If that first test is negative, you wait two weeks. You can continue to produce eggs for the table egg market. That first thousand egg test was negative. You wait two weeks and you do a second thousand-egg test, the same thing.

MR. CUTLER: Okay. As long as you continue testing negative, you keep producing for the table egg market?

MS. BUFANO: Yes, yes, you do not--you don't--

MR. CUTLER: There is no diversion until you find a positive egg test?

MS. BUFANO: That is exactly right.

MR. CUTLER: Thank you.

MS. BUFANO: You do not have to divert your eggs until you actually find a positive egg test.

DEPUTY DIRECTOR CARSON: Any other--yes, David?

DR. CASTELLAN: David Castellan, California Department of Food and Agriculture.

Mr. Carson, I have a question for you. You mentioned in your opening comments that production labeling and refrigeration will decrease human incidents of SE by 50 percent to reach the Healthy People 2010 goals. What is the basis for that calculation and does that agree with the estimates from the SE risk assessment that FSIS did?

DEPUTY DIRECTOR CARSON: Okay, let me--what I said was, the totality of all three rules that FDA is putting forward, our goal is to reduce SE illnesses by 50 percent by the year 2010. Our estimates are that, this rule that we are proposing here will contribute about 35 percent of that overall 50 percent goal and the egg labeling and refrigeration contribute about 15 percent of that overall 50 percent goal.

As Nancy has mentioned, we are basing this on the 1998 FDA/FSIS risk assessment, if that is what you are asking about. Based on that risk assessment, it did point out for us to look at on the farm as having the major contribution to overall risk reduction for SE illnesses.

DR. CASTELLAN: What is the foundation for that estimate being able to reach it using those three points in the food production process or food production labeling and refrigeration? I mean, what is the--what were the--what risk assessment was done to arrive at that figure, that you can reach that threshold value, that goal that you have there?

DEPUTY DIRECTOR CARSON: Well, we--again, it is contained within our rule, within the economic analysis section of the rule, where we show how we derived our net benefits of reducing SE illnesses based on the outcome that we are putting forward as our goal. So, it is in the economic analysis part that, if implemented, all of the steps we have put forward on-farm, we would then reduce the number of SE-contaminated eggs and, thereby, reduce the number of illnesses. Obviously, it would not go to zero.

So, that is the basis, where we are getting our numbers, if that is answering your question.

DR. CASTELLAN: I would only point out that, last night, I did read something in the SE risk assessment that indicated in the executive summary or near the beginning of the document relating that production, processing and food handling and consumption phases combined together could reduce SE by 25 percent. So, I'm just trying to align those two estimates that you have just given us with what I just read in the SE risk assessment.

Again, it is just something to look at.

DEPUTY DIRECTOR CARSON: Okay, we will look at it. Thank you.

Yes?

DR. KINDE: I am Halo[ph] Kinde[ph] with the California Animal Health and Food Safety Laboratory. I am a veterinary microbiologist.

I have a question for Nancy Bufano. In the environmental testing for SE, actually the layers won't be tested until they are 45 weeks of age. What is the basis for that?

DEPUTY DIRECTOR CARSON: The basis of the timing for the environmental testing was an agreement between the United Egg Producers, FDA, USDA and Food Animal Concerns Trust and it represents a mean period of time in which we would conduct one test. But it is basically contained within an agreement that we have with industry.

DR. KINDE: That means the layer flock is safe until 45 weeks of age?

DEPUTY DIRECTOR CARSON: Well, all food is assumed to be safe unless you find an adulteration. So, again, what we are trying to do here with the environmental testing, as Ms. Bufano stated, was to verify that the on-farm measures are working. If the on-farm measures are not working, then we believe the testing will identify those failures and then take additional steps with the testing that we have laid out here.

If you do find a positive egg, then there is diversion as the consequence of that.

DR. KINDE: I'm sorry, just for more clarification, is there a reference for the selection of the 45 layers?

DEPUTY DIRECTOR CARSON: Yes and it is contained within the rule. We can specify that and we can give that to you, perhaps, at break.

DEPUTY DIRECTOR CARSON: Yes?

MS. CURTIS: Pat Curtis, Auburn University.

I just have a question about the rule and decisions regarding the retail side or not including the retail side in the proposed rule.

According to CDC, 62 percent of the outbreaks were from commercial venues and, yet, in the comments you're asking for, specifically coming back for are for the health institutions or susceptible populations. Is there a reason? What is your thinking behind not just requiring all of the retail--you know, like the food code to be met by all the retail facilities?

DEPUTY DIRECTOR CARSON: Again, what we are putting forward--we already have standards established through the Model Food Code and for states to both adopt and then implement those provisions. One of those provisions or what the health care community can do is to purchase in-shell pasteurized eggs or pasteurized egg products to serve to their populations that would reduce their risk for those particular targeted populations.

So, those are already on the books. The question is, should they be mandated and regulated by FDA or should they continue to be mandated and/or regulated by state officials. That is the difference.

MS. CURTIS: No, that wasn't my question. My question related to why you chose the smaller percentage of people that would be impacted versus the larger, where it is the commercial venue and not just the susceptible populations through institutions. I mean, if you're talking about 62 percent of the outbreaks occur in just general, commercial facilities, I was wondering why--some states adopt the food code. Some adopt it only in part, you know--why you wouldn't just make that a mandatory if you're going to go and try to reduce everything and reduce it at the producers' level?

It looks like you would also go to the consumers' level, because you get abuse on egg handling that, even if it is refrigerated and it's abused at the retail level, which is often the issue, then you end up with growth on that end. I'm not talking about just in institutions, but in general restaurants.

DEPUTY DIRECTOR CARSON: I believe we have tried to lay out our rationale as to why we have done what we have done. We told you--obviously, the most sure-fire way is to reduce the presence of SE in eggs, regardless of what happens downstream.

You are right; certainly, we are not going to reduce it to zero. So, the presence of some contaminated eggs will occur in the chain of production and retail. So, what we have proposed is to impose refrigeration all the way down the line and through the Model Food Code, we have tried to establish time and temperatures for cooking those eggs to maintain them to be safe.

The question before us is, should FDA and the Federal Government mandate those at the state level? That is a big question. That is not a simple question.

You may or may not know about preemption [sic] at the state level and it is a very sensitive subject as to whether Federal Government should preempt states on how they deal with retail. FDA does set standards, but it does not implement those standards at the retail level. That is done at the state and local level.

[Pause]

DEPUTY DIRECTOR CARSON: Okay, going back to a previous question, we have the references that were asked by a previous questioner.

Dr. Brown.

DR. BROWN: [Off microphone]

DEPUTY DIRECTOR CARSON: Please speak into the microphone.

DR. BROWN: Yes.

We actually used a few different references. For moderate cases of Salmonella poisoning, we used "Williams' Costs of Visits to the Emergency Room." It is a paper and it is in the "New England Journal of Medicine." That is Reference 85 in the document.

For severe cases, we used "Health Care Costs and Utilization Projects: A Nationwide Inpatient Sample." That is Reference 87 in the document.

For the medical costs of arthritis, we used Zorn and Klontz, "Diet Consumer Loss Due to Reactive Arthritis." That is Reference 81 in the document.

MS. CURTIS: Thank you.

MS. BUFANO: I can answer the question about the reference used to arrive at the 40 or 45-week time period or age of birds to conduct the environmental testing.

In the rule, published in the "Federal Register" on--it's discussed page 56837. "Information from an egg QA program with a testing protocol indicates that the highest numbers of positive environmental samples are found when laying hens are 40 to 45 weeks of age." That is Reference No. 57.

It goes on to say, "the layer study, which is Reference 27, found that flocks less than 60 weeks of age were five times more likely to test positive for SE than older flocks." That's where we arrived at that time frame.

DEPUTY DIRECTOR CARSON: Are there other questions?

DR. BELL: I am Don Bell, from the University of California.

A continuation of Dr. Cutler's question. Once the eggs are under diversion, what is the process to get them out of diversion?

DEPUTY DIRECTOR CARSON: As we showed you, once they are in diversion, they must test negative four times over an eight-week period for batches of a thousand eggs each.

DR. BELL: Okay.

The once a month testing, what did that apply to?

MS. BUFANO: If you had an positive egg test at one time, but then you got the four negative tests so you were able to go back into table egg production for that flock, you still must test once per month, one egg test per month for that flock, because you did have a positive egg test at one time from that flock. So, you have to do that one test per month for the life of that flock.

DR. BELL: I thought I recalled that when I read it, but I was a little confused.

The diversion applies to a single house, a group of houses of the same age or a farm or what?

MS. BUFANO: The diversion applies to the house. We define a flock as a group of hens in a house, not of the same age, but a group of hens in a house. That is a flock, as defined in the rule.

DR. BELL: You don't want comments now, but we will give those later.

Okay.

DEPUTY DIRECTOR CARSON: Any other questions?

[No response]

DEPUTY DIRECTOR CARSON: Okay, let us take a 15-minute break and be back about 10:35. At least, on my watch, I have 10:20. So, a 15-minute break and we will come back for those comments.

Again, we have about four to five who have registered to comment. I will call on them first and then any others who are in the audience who wish to comment, we will offer you that opportunity after that.

So, thank you.

[Recess]

 [Stakeholders' Public Statements]

DEPUTY DIRECTOR CARSON: [In progress] --the program. We do have a number of registered commenters and we will call on them first. Then following that, I will open it up to the audience for any additional comments people would like to make.

The first is Douglas Kuney[ph], area poultry farm advisor, UC Cooperative Extension.

MR. KUNEY: Good morning. I'm Doug Kuney. I'm an area poultry farm advisor, for the University of California Cooperative Extension. My job is to bring science-based information to the commercial poultry industry and help the industry incorporate that information to the benefit of the producers and the consumers of the State of California.

I agree with the FDA, the quality assurance programs benefit producers and consumers in that, they reduce the risk of SE and other pathogens from contaminating our food supply. I also agree that all major sources of eggs should be produced under a solid, well thought out quality assurance program.

Because there are significant differences between states and even sometimes within states in climates, the environment, management practices and housing types that, quality assurance programs need to be tailor-made to address local concerns. I believe that all states that produce eggs should do so under a science-based quality assurance program that has been developed for the unique needs and conditions. I do not believe that a one-size-fits-all program will adequately address the needs of our nation.

In California, in 1994, the California Egg Quality Assurance Program was first introduced to the egg industry. Prior to that, California was experiencing a crude population rate of about eight human cases of SE per 100,000 population. Since 1997 when the California Egg Quality Assurance Program was implemented, California has experienced a steady decline in this rate to 1.8 per 100,000 in 2003. We have not seen a human outbreak associated with California-produced eggs in five years.

In 2003, we did have one outbreak associated with eggs imported from another state, however.

I believe that other than a reduced risk from imported eggs, that California consumers will have little or nothing to gain from a program that is less comprehensive than the California Egg Quality Assurance Program. I am very concerned that this proposed program, if implemented in California, will severely undermine all the hard work that has been done over many years by the industry together with the California Department of Food and Agriculture and the California Department of Health Services in establishing strong working and cooperative relationships.

The egg industry together with the California Department of Food and Agriculture, the Health Department and the University of California has made significant progress in protecting the consumer and in regaining consumer confidence in our egg products. In addition, we don't know what the impact will be on producer participation in the California Egg Quality Assurance Program if this program is forced upon them.

In California, I would like to stick with what has gotten us here and not try to fix something that is not broken. I would like to see the FDA look carefully at each state's quality assurance program to see that they are science-based and well thought out. Those states that have sound programs should be sanctioned [sic] by the FDA and those states that have either weak or non-existent programs should be assisted by the FDA to develop sound programs.

This will assure that programs across the nation will be specifically designed to meet the local needs of the industry.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you very much.

Next is Dr. Richard Breitmeyer, California Department of Food and Agriculture.

DR. BREITMEYER: Thank you.

My name is Richard Breitmeyer and I serve as state veterinarian for the California Department of Food and Agriculture. Thank you for the opportunity to provide comments to the proposed regulation to prevent Salmonella Enteritidis during production.

Here in California, representatives from government, industry and academia have worked closely together to over the last decade to address this critical food safety issue. In 1994, the California Egg Quality Assurance Plan was developed cooperatively by industry representatives, government officials and university scientists to reduce the risk of SE and other food safety hazards from eggs. This comprehensive program remains very successful today, as over 90 percent of California's eggs are currently produced under this program by approximately 45 certified farms and processing plants.

The broad support for this program was recognized by the signing of a partnership agreement in 1997 by the Food and Drug Administration, the United States Department of Agriculture, the California Department of Food and Agriculture and the California Department of Health Services, as well as representatives from the California egg industry.

In addition, this partnership was recognized in 1998 for reinventing government and received the prestigious Vice Presidential Hammer Award.

The egg quality assurance program is a comprehensive program with third party oversight. The University of California Cooperative Extension provides ongoing training classes and each industry participant is required to have trained supervisors who are in charge of implementing the program. Producers must develop a specific flock plan to address chicks, pullets, feed, rodent control, flock health, biosecurity and environmental monitoring for SE.

Processors must meet strict requirements for facilities, equipment, biosecurity, cleaning and disinfecting and refrigeration. Veterinary medical officers from our department provide the third party audits of the program. Any participant found out of compliance is given a notice to address any program deficiencies. Failure to comply with the mandatory requirements results in loss of certification.

As an added incentive, many companies will not purchase eggs from a producer that is not certified.

While it is difficult to determine the effectiveness of an on-farm food safety program in the overall farm-to-table continuum, it is worth noting that there has not been an SE outbreak traced back to California eggs for more than four years.

Because of the success of the existing egg quality assurance program and other similar state plans, we strongly recommend that FDA consider adopting state programs as an alternative to the proposed regulation. Under such an agreement, FDA would recognize any producer in full compliance with an approved state plan as meeting the requirements of the egg safety regulation.

Such an agreement would continue to support the integrity of the many state programs, which are often much more comprehensive in scope than the proposed regulation. If any regulation does go into effect, we recommend that FDA contract with states to administer production egg safety programs. The California Department of Food and Agriculture would welcome such a partnership with FDA to administer the California program.

Our department has the expertise and the infrastructure in place to provide administration for this program. Such a partnership would provide a seamless transition, since we already provide third party audits of the California Egg Quality Assurance Program.

We also encourage FDA to review available research and to consider alternate strategies to prevent SE contamination of eggs, including vaccination. Vaccination is an important part--I'm sorry -- vaccination, as a part of a comprehensive plan, may be very cost-effective to prevent SE-contamination of eggs. Such prevention strategies may prove to be more effective in protecting public health than relying on testing and diverting after the fact.

In addition to prevention strategies at the producer level, CCFA supports a much more comprehensive approach to egg safety. We recommend mandatory adoption and adequate funding to enforce the egg safety requirements in FDA's Model Food Code, to insure proper handling and preparation of eggs.

As an example, only pasteurized eggs should be used in an institutional setting where food preparation requires pooling of eggs. Many current outbreaks continue to be the direct result of improper food handling, an important risk factor that must be more effectively addressed.

Dr. Dave Castellan of our staff will provide some specific, technical comments this morning and we plan to provide additional comments in writing.

Thank you, again, for the opportunity to comment today.

DEPUTY DIRECTOR CARSON: Thank you.

Next, Dr. David Castellan.

DR. CASTELLAN: Thank you for the opportunity to provide input at this important hearing. My name is David Castellan and I am a staff veterinarian and epidemiologist with the California Department of Food and Agriculture.

I will direct my comments at four issues related to FDA's proposed rule that will impact the ultimate goal of reducing Salmonella Enteritidis in humans.

First, the epidemiology of human SE is dynamic, both regionally and over time. Regional differences and the predominance of specific SE phage types exist in the United States and human SE has declined in California over time from 3.6 cases per 100,000 population in 1993 to 1.76 cases per 100,000 in 2003. The percentage of California outbreak cases due to SE was at a maximum of 21.84 percent in 1996 and was recently at 3.4 percent of outbreak cases in 2003.

Changes in the agent, animal and human host immunity, environmental reservoirs and mitigation efforts through existing quality assurance programs may have contributed to current cyclic reduction in human SE.

Since FSIS SE risk assessment, quote, does not attempt to reflect changes in SE occurrence over time, unquote, and is based in large part from regional data collected in Pennsylvania, CDFA recommends that FDA continue to assess regional changes and patterns over time so as to optimize regional pathogen production efforts in relevant risk-based prevention and control strategies.

It is also important to note that extrapolation of findings from [unintell] data used in the proposed rule may be limited since farm selection was neither strictly randomized nor [unintell]. The second point, CDFA urges FDA to develop and utilize science-based standards and performance measures. Although the proposed rule is in the form of a regulation, it is only through the application of process control principles, such as, good agricultural practices and hazard analysis critical control points that progress at the production level can be measured against such standards and outcome measures.

The California Egg Quality Assurance Program incorporates such process control principles.

CDFA recommends that the proposed rule incorporate flexible standards, addressing sample collection, sample analysis and intervention actions. CDFA further recommends that outcome measures used to assess the program consider both internal components of the pathogen reduction program itself as well as external assessment of other emerging sources of SE.

The proposed rule is unclear as to total testing costs and who will bear these costs. CDFA intends to provide projected written cost estimates pertaining to the sampling process for the public docket.

Thirdly, implications of the proposed rule for future trace back investigations. CDFA strongly urges FDA to work with state epidemiologists and poultry professionals to develop rigorous, uniform, unbiased and science-based standards for conducting trace back investigations and to work cooperatively with state officials and poultry professionals in prescribing specific corrective action at the production level. Every outbreak investigation needs to be fully completed, documented and treated as a learning opportunity that will prevent future outbreaks.

Response strategies must also be developed to address false positive, non-motile Salmonella Group D:1E[ph] other than SE. Furthermore, CDFA encourages FDA to consider indemnifying producers when it is necessary to depopulate effective flocks, as practiced in Canada.

Fourthly, the FSIS SE risk assessment states that, quote, broadly based policy may be more effective than a policy directed solely at one area of the egg production to consumption chain, unquote. Production, processing, transportation, food preparation and consumption all impact the safety of shell eggs. For this reason, it is essential that FDA continue to work with other federal and state agencies to develop a comprehensive and coordinated effort that can effectively reduce the incidence of SE in humans.

With this testimony, I'm also submitting published peer review scientific articles that will correct and update information concerning the technical requirements of the California Egg Quality Assurance Program that appear in the proposed rule. Further written comments will also be submitted.

Finally, I would like to close my comments by posing the following question. Why did 91 percent of all egg production premises participate in the California SE validation study? Science has been the unifying force that has built trust among egg producers, animal and public health regulatory officials, academia and the general public. Partnerships assure that all parties benefit.

CDFA welcomes the opportunity to partner with FDA in a science-based, process-oriented approach that will ensure the continuing availability and safety of eggs produced in California.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you.

Next is Dr. Nancy Rheimer[ph], from Cutler Associates.

DR. RHEIMERS: Good morning.

I'm Dr. Nancy Rheimers. I am a consulting veterinarian with Cutler Associates. I just wanted to address a few points.

First, I would just like to add my voice to the strength of the California Egg Quality Assurance Plan. This is a wonderful, comprehensive program that has a large amount of producer buy-in. It has had a strong impact on human illness in our state.

The strengths of the program includes the education that it has as well as the recordkeeping components that are addressed at tracking the prevention that actually is occurring on the farm as opposed to simply relying on times when that prevention no longer works and simply tracking testing. I think it is important that we keep track of what we do to prevent disease and prevent its reduction [sic] of Salmonella into the birds as well as keeping track of other things.

The other area that I think is particularly strong in the program is the biosecurity component. Within this state, particularly within this portion of it, we have had a lot of experience with exotic respiratory disease being spread from bird to bird. Our biosecurity plans are largely directly at preventing that. They certainly, because we are looking at preventing avian influenza, which is currently at a pandemic level as well as our previous experiences with exotic Newcastle disease, we have developed programs that are more than adequate to address any Salmonella introduction.

Our programs address the disease introduction typically at the farm level as opposed to bringing it down on a house per house level. In terms of spreading the Salmonella from house to house, rodent control and vaccination seem to be more effective prevention measures at that level than simply controlling the spread of it on people and personnel, although those are incorporated as control measures as well.

Thank you very much.

DEPUTY DIRECTOR CARSON: Thank you.

Greg Cutler, Cutler Associates.

MR. CUTLER: Hi, I'm Greg Cutler. I'm the owner of Cutler Associates. We provide consulting veterinary services to the poultry industry internationally.

I strongly believe that any program that is put into effect needs to include poultry veterinarians, veterinarians who are licensed, federally accredited and who are diplomats of the American College of Poultry Veterinarians. These people are the best ones to offer effective implementation of biosecurity plans and food safety plans.

The California Egg Quality Assurance Plan has been a rousing success. Egg quality assurance plans in general have been very successful, as indicated by the graphics presented here this morning. The California plan, as indicated by Dr. Breitmeyer, is a partnership between FDA, USDA, CDFA, CDHS, the University of California and industry and as Dr. Breitmeyer has said, has been recognized for its unique approaches and successes.

The success of these quality assurance plans is documented in the literature. In California, 95 percent of eggs and 85 percent of producers are participants in this plan, which is overseen by CDFA with third party accreditation.

As indicated by a couple of the speakers there has been no SE from eggs in California from California produced eggs for a number of years.

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

MR. CUTLER: [In progress] --appropriate time to test flocks. At this time, it gives you the best opportunity to respond to any problems in that flock.

Cleaning and disinfection is best done when the houses are empty. Rodent control likewise is done when there are no birds and no alternate sources of feed that will attract rodents as opposed to rodent baits.

The current programs are action-based programs and need to be recognized as effective as they are by FDA.

Egg producing states without egg quality assurance plans should be on some federally-mandated program. Those states who have good quality egg quality assurance programs should in some way be exempted from the federal plan as long as the standards for their egg quality assurance plans are monitored and are accredited.

I think that the current plan, as presented, does not give nearly or really any credit to vaccination as a point in control of SE human disease. Effective, safe vaccines, both live and killed, are available. They are quite cost-effective, are easily done. As I said, they have been shown in the literature to be very effective.

I thank you for the opportunity to comment.

DEPUTY DIRECTOR CARSON: Thank you very much.

That is the last of the registered speakers or commenters. Are there others in the audience who would like to comment.

Please, sir.

MR. O'DAY: Good morning.

Thank you for the opportunity to provide comments on the FDA egg safety rule.

I am Danny O'Day, Vice President of California Operations for Valley Fresh Foods, Incorporated. I also serve as the Chairperson for the California Egg Quality Assurance Program Advisory Committee.

Our company believes in producing safe, wholesome table eggs and egg products for human consumption. In 1995 when SE was on the rise nationwide and in California, we spoke with other producers, scientists and people in governmental agencies to find out the best course of action to take in order to reduce the incidence of SE.

The California egg industry in cooperation with the California Department of Food and Agriculture, the U. S. Department of Agriculture, UC Cooperative Extension Service, California Animal Health and Food Safety Laboratory System, California Department of Health Services and the U. S. Food and Drug Administration developed a voluntary animal production food safety program. The California Egg Quality Assurance Plan was implemented in 1994 and has been in continuous operations since that time.

It has been recognized as one of the premier egg quality assurance plans in the United States and was awarded their prestigious Golden Hammer Award for reinventing government by Vice President Al Gore.

SE cases and outbreaks have dramatically fallen in the last four years. There was only one outbreak traced to California or in California and it was determined that the eggs were produced out of state. I think that is a remarkable record.

CQAP is always an evolving program that continually updates its components as needed. Recent amendments to the plan include enhancing the biosecurity and processing core components to reflect updated disease control measures. Additionally, CQAP is working with the California Department of Food and Agriculture to update the auditing compliance procedures for CQAP-certified operations.

CQAP provides a network clearinghouse for gathering and distributing the most current information available for insuring product quality and food safety associated with SE. CQAP develops or assists in the development of individual flock and processing plant quality assurance plans, coordinates initial evaluation by the California Department of Food and Agriculture veterinarians.

Currently, CQAP coordinates and develops continued education, training workshops with CQAP members, governmental agencies and university cooperative extension personnel. All CQAP certified personnel are required to take continuing education classes to maintain their certification.

The continuing education component of the program is designed to keep certified individuals up to date in cutting edge technology and information relative to production, processing and nutrition.

We support the efforts of the California Egg Quality Assurance Plan and recommend that states that have a reliable quality assurance plan be exempted from the FDA rule. We will submit comments in written form to fully document the California plan.

Again, I thank you for the opportunity to present these comments today. We look forward to working with the FDA in developing a sound and scientifically valid plan that will protect human health and not put an unfair burden on egg producers.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you.

Other comments? Tom.

MR. SILVA: Thank you.

My name is Tom Silva[ph] and I am an egg producer and proud to be one, have been for over 30 years. I am Vice President of J. S. West and Company in Modesto, California. We are or they are a family-owned company, established in 1909 in Modesto.

We produce, pack and distribute over 30 million dozen eggs a year in California. Our company has been a part of CQAP or the California Egg Quality Assurance Program since its inception in 1995. We take food safety very seriously and believe CQAP has been instrumental in our ability to supply a wholesome product in California.

Some of this gets redundant. Everybody has the same notes.

There has been only one confirmed case of SE in California in the last four years. That, again, was produced outside of the state.

I feel very strongly that under the direction of Dr. Richard Breitmeyer that CQAP should be the program we continue to follow and adopt here in California or that FDA adopt and let California continue. States that do not have a program like CQAP should be forced into that type of an egg quality assurance program, either through FDA or through their state programs.

The other little thing that happened this year in California that I don't know that it is covered in your plan, but eggs were brought in from Mexico when our prices got overly high this year. Those eggs are not tested for SE or AI or any other programs either. So, I don't know how that is going to get into your program to allow imports in.

So, in summary, I would like to ask you to allow CDFA to continue to regulate the plan in California. They have the trained staff, the veterinarians and the proven track record of compliance and success.

So, I'd like to thank you for the opportunity to present these comments.

DEPUTY DIRECTOR CARSON: Thank you.

Other comments?

Yes, sir.

MR. ERSTIN: My name is Ralph Ernstin[ph]. I am a retired poultry specialist with the University of California, probably the only one here who was on the original committee that wrote the California Egg Quality Assurance Program. Others might have been here if they were still working.

We wrote this program really with the council of the industry. So, while we say that a few people wrote the program, in actuality there were over 50 people obviously who contributed to the present document. It has become a living document.

So, one of the points I would like to make is, that these programs need to be flexible. If you need to respond to local conditions in your quality assurance program and if you set regulations that are too specific, it is going to make it difficult for people to respond to local challenges.

Recently, we have had a very significant local challenge, which was the outbreak of exotic Newcastle in southern California. This has had a major impact on what we could do during this interim period and, certainly, maybe our laboratory people will comment on that, because of the incredible load of laboratory work that involved.

I would like to comment on a few other areas, specifically where requests were made for comments. One is about written quality assurance plans. Of course, California's quality assurance program requires that. I think that is absolutely critical to success, if you are going to use a quality assurance approach to reducing Salmonella Enteritidis. You will find that written plans are required and, further that, written records are necessary if you are going to have oversight of this kind of a plan.

At very best, an inspector can make a brief visit. Because of biosecurity, a veterinarian, for example, from our Department of Food and Agriculture can only make about two visits a week without endangering the biosecurity of these farms.

So, oversight is difficult and it has to be a fairly brief visit. Certainly, they can look at houses, but you have to keep in mind that, some of these companies have in excess of 40 chicken houses. Certainly, their biosecurity regulations prohibit the inspector from going between houses. So, the oversight is going to be dependent primarily on the records that are available to be reviewed and the obvious compliance that can be seen externally.

So, if you are going to have effective oversight, I think you both have to have records and you have to have a written quality assurance plan to review.

Nobody has commented on farm egg refrigeration. When I first read this rule, that jumped out at me, because you had suggested that eggs ought to be refrigerated on farms to 45 degrees Fahrenheit. Forty-five degrees allows us a very narrow opportunity for egg wash water temperatures--most of our USDA egg processing plants or state-licensed plants wash eggs at 110 to 115 degrees. This is the most effective wash water temperature to use. There can't be more than a 50 degree temperature difference in the incoming egg temperature and the wash water temperature.

Therefore, if you refrigerate eggs to 45, the egg plant will have to reduce their egg water processing temperature down to 95, which is the lower level allowed by the USDA, if you are a USDA plant. In other words, it is technically feasible, but it will create problems and I think you will end up washing the eggs at an inferior temperature.

The reason for this 50 degree range is, when you exceed that, research has shown that you will get an increase in thermal checks when you wash those eggs. Certainly, we have reams of data which shows that cracked eggs or more likely to be contaminated by bacteria than intact eggs.

So, we really don't want to increase the number of cracked eggs in our commercial egg channels. So, it is critical that this be reviewed. Certainly, it should be coordinated with whatever requirements are going to be in place in the egg processing plant so that the temperatures are compatible.

We have in the universities all across the United States, certainly, for years recommended a farm refrigeration temperature of about 60 degrees Fahrenheit, knowing that those eggs were then going to go into the egg processing plant and be subjected to a higher temperature during the washing process.

Dealing with SE-positive houses, it's a little unclear to me in reading the document exactly how you expect the producer to do this. I would like to point to a couple of things that jumped into my mind immediately when I looked at this.

For one thing, you will find a lot of farms would have almost an impossible situation in the event of a positive flock, assuming the eggs were found SE positive and the farm wants to get rid of those birds and not divert the eggs to the breaker or at the end of the cycle, when he is required to get rid of those birds, he is supposedly going to do a wet cleaning and remove all of the manure.

However, he may be faced with regulations on waste handling, which prohibit him moving the manure at that time of the year. You're not allowed to spread manure, for example, on frozen ground. In some areas of the country, you can't stockpile manure on site. Therefore, what are you going to do with it?

You could compost it if you had a composting operation. Obviously, at this point, a lot of people don't. Some do. So, you have really limited the options this producer has.

Currently, in many of these cases, the flocks are replaced and the manure is left in place in the house until the appropriate time for clean out. Then when it is cleaned out, it is applied directly to farm land at the appropriate season of the year. This regulation does not allow for that seasonal clean out. It is going to force clean out at that time and then it is going to force wet cleaning.

As soon as those chickens are removed from the house, the temperature will drop to whatever the ambient temperature is. In California, that is not much of a problem for us. But in Minnesota, I would think it's a huge problem. Trying to wet clean a house when the water is going to freeze in the house is going to be a near impossibility.

I think that the regulation should allow the ranch to find the appropriate mitigation measure in the case of a positive test. As Dr. Cutler has just stated, vaccination may be the most appropriate response and certainly it has been proven effective. There are other things that can be done other than wet cleaning and removing all the manure to control this problem.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you very much.

Additional comments? Age before beauty.

DR. BELL: Don Bell, University of California, retired poultry specialist.

I have been asked to review the economic impacts both on a national level and on a California level. I just wanted to comment very briefly that economic impacts involve capital investment, involve continuous monitoring programs along with the associated recordkeeping. It involves the possible cost of diverting eggs for unknown periods of time.

The one immeasurable is the public reaction to the existence of programs and their confidence in shell eggs.

The house concept in the current program as far as testing is concerned and diversion poses a real problem for California because of the large number of small houses that we have. I don't know where these numbers came from originally, but the [unintell] program, for example, talks about one and two-house farms. In California, we have--I can't even think of a single farm that has one house. Most of our houses have eight, ten, 12, 14, 20 houses and some 50 houses.

Using a test for each of those houses becomes very expensive and penalizes the small house more than the large house. I visited farms in Iowa this last week, 250,000 birds. That is ten times as many birds on one test that a 25,000-bird farm in California.

Some of the questions we had are breaking plants available? In certain regions, they are not. What distance? At what price will such eggs be sold relative to the normal marketing methods? A penny a dozen discount is 20 cents a bird, 22 cents a bird. It's a sizeable portion of the profitability of the egg industry.

The comments earlier by many people, the recognition of the existence of--the strengths of existing programs is recognized by the FDA. Unique to these programs is the fact that, the participants have taken on considerable added expense on a voluntary basis to conform to the program. In addition, extensive educational programs that resulted in a very knowledgeable industry, as you've heard our speakers today from the industry. Close working relationships between local regulatory agencies and egg producers have occurred.

Our producers have gained experience, much needed experience and also the working relationship with the agencies cooperatively.

There are many cost assumptions made in the report. The [unintell] report was a major source of information for that. I was on that committee that put that together. I already talked about the number of farms, the houses.

One of the problems was that, the calculations for expenses to the grower were broken down on the house capacity ranges, with no recognition that all farms are different. So, when a cost--for example, your $82 million cost is like 30 cents a bird. That is an average. If we have a cost of 30 cents a bird, that means somebody has a cost of 50 cents and somebody else has a cost of ten cents. A 50 cent cost is quite high. Even a three cents cost is very high for a program of this type.

The document, the FDA document, those of us who have tried to read through it, there are items in there that are based on science. There are the scientific facts that we are all concerned about. But there is also certain proposals that are very controversial, wet cleaning, for example. There are areas in there where the exact opposite view is made on some of those comments.

Then the third category are the dozens of comments that are requested by the industry. That indicates either a lack of knowledge that we collectively have on those subjects--I think I counted 25 or 30 in the document that we have problems with having enough information on.

I would hope, we would hope that the new regulations be based upon those which reflect good science. Errors in the selection of program guidelines can lead to expensive costs to the egg industry and may not add materially to the goal of SE reduction in the nation's food supply.

A final comment.

Profits in the egg industry are variable from year to year. Five cents a dozen profit would probably satisfy most of these people, which is equal to a dollar a bird. So, a 30 cents cost and a dollar would be exceedingly generous to the industry as a 30 percent cut in profits. So, there are years where we have no profit whatsoever, but the 30 cents would go on during those years.

So, it's quite a variable industry as far as profitability is concerned.

Thank you.

DEPUTY DIRECTOR CARSON: Thank you very much.

Next?

MS. MURDOCH: Thank you for the opportunity to provide comments on the FDA's egg safety rule. I am Debbie Murdoch, representing the Pacific Egg and Poultry Association, otherwise known as PEPA.

PEPA is a non-profit trade association representing egg producers throughout the western United States as well as Hawaii. We represent over 90 percent of the egg production and distribution in the State of California.

In April and again in July of 2000, we presented testimony at the FDA public hearings on national standards for egg safety in Sacramento and Washington, D.C. Much of what I have to say today is similar to our testimony in 2000 with the exception that we have had four additional years of experience in controlling Salmonella Enteritidis.

While it is certainly appropriate that national standards relative to egg safety be established and that all producers of shell eggs implement a program to meet these standards, it is equally appropriate to recognize the importance of regional differences and regional tools currently in use today by producers to insure egg safety. Existing state egg quality assurance programs are one of the most effective tools used by industry to control SE.

On the west coast, California and Oregon have state egg quality assurance programs and in Washington, most producers follow similar programs. These programs are working extraordinarily well, as evidenced by the marked decline in egg-related SE outbreaks, which you have heard, particularly the California example.

The California Egg Quality Assurance Program has been nationally recognized. Oregon's plan is patterned after California's. The core components form the basis of a hazard analysis critical control points plan. Continuing education, training, recordkeeping, research and third party auditing are integral parts of the plan. These plans are constantly evolving and are developed and implemented in the food safety arena.

CQAP already incorporates the majority of SE prevention measures outlined by FDA. Most existing state quality assurance programs, including the UEP Five-Star Program could be modified to meet the requirements of the proposed FDA rule. The FDA would certify those programs and the state would be responsible to FDA to report producers in compliance with the state program.

Those producers not currently participating in a quality assurance program could elect to join the respective state program or simply meet the federal standards, as required. In essence, we would have a level playing field across the United States that allows for regional differences relating to the production practices, climate, the absence or presence of egg quality assurance plans, differences in components of those plans and state statutes that are in place to deal with food and egg safety.

Among the regional differences that need to be addressed by FDA is breaking capacity. The rules do not take into consideration that some areas, particularly in the west, do not have breaking capacity. The current market situation in California's status as an egg deficit state makes extension of breaking plants' capacity highly unlikely.

In Hawaii, there is no breaking plant.

To require a producer to divert all eggs for a period of up to eight weeks without some form of compensation could result in serious economic damage to that individual. I'm sure they would go bankrupt.

Also, FDA does not address the issue of laboratory capacity and costs associated with the testing, false positives and the potential economic consequences of such incidents. Since many states, such as, California already have the infrastructure in place that has proven to be an effective tool in the reduction SE egg-related outbreaks, why reinvent the wheel?

We recommend that those producers operating under a proven comprehensive egg quality assurance plan be deemed in compliance with the rules FDA will promulgate. Additionally, more emphasis on educating the public about proper food handling procedures and requiring processors and food service establishments to adopt stricter controls relative to food safety should be mandated.

If FDA truly wants to insure the public's health, the agency must develop and implement a controlled plan based on sound science that covers the food chain in its entirety, from production to distribution and processing.

Twenty of the 29 SE outbreaks reported nationwide in 2002 occurred in commercial food establishments. Producers should not have to bear the burden of zero tolerance when they have no influence on the food handling component in the food chain.

In conclusion, I am not a producer nor am I scientist. I do, however, serve as a liaison working with industry and government. Good communication and effective management are key elements to the success of any disease control program. You can be assured the egg industry remains committed to producing a safe, healthy, nutritious product.

Thank you for the opportunity to speak to you today.

DEPUTY DIRECTOR CARSON: Thank you.

Other comments?

Yes, sir.

MR. WILLARD: Thank you for the opportunity to provide comments today. I understand the agency's intent and goal to reduce SE. I think this is a very important meeting--

DEPUTY DIRECTOR CARSON: Just give your name and your affiliation, please.

MR. WILLARD: Yes, my name is Craig--I was next on the list here.

DEPUTY DIRECTOR CARSON: Oh, I'm sorry. You never know. That's why I thought I would ask.

MR. WILLARD: My name is Craig Willard[ph]. I'm President of Norco Ranch, Inc. and general manager of a group of companies, including [unintell] Enterprises, Eggs West and High Point Industries here in southern California in the southwest. We own approximately four million laying hens in this area and maintain an integrated operation from brood and grow to feed milling to marketing eggs in the region.

Through one of our companies, we break and further process eggs, primarily for food manufacturers.

We have been in operation since 1939 and have seen quite an evolution in the industry and in the regulatory environment. Given the size of our organization and the demands of our retail food service and manufacturing customers, we believe that good animal husbandry and stringent food safety go hand in hand with good business results. Frankly, we cannot afford to operate otherwise.

We firmly believe in producing safe and wholesome table eggs and egg products for human consumption. That position was enhanced when we joined the California Egg Quality Assurance Plan in the mid-1990s when SE was on the rise nationwide and in California.

As you have heard many times today, SE cases and outbreaks have dramatically fallen. This is mirrored in our company's own records. We have not had a single positive SE result from any of our animal environmental testing, which has taken place since adoption of the program and our production manager provided me a couple of year's worth of the tests right here. We are proud of our record and expect to continue that.

In addition, it is interesting to note that we are also under the strict requirements of various customers, including customers like Walmart, in an effort to promote food safety. These companies conduct their own audits and have placed certain requirements for us to be able to serve them eggs. I believe you will find similar conditions exist with our industry competitors. It is the environment in which we live and the nature to whom we sell these days. They simply expect a very safe food product.

As a result of such requirements, we have implemented detailed HACCP programs, strict biosecurity measures, additional GMPs and revised operating procedures to meet various needs. We perform three SE vaccinations on every flock we raise, including flocks grown for other producers. For us, the emphasis is on prevention first.

We support the efforts of the California Egg Quality Assurance Plan and recommend that all states that have suitable functioning quality assurance plans be recognized by the FDA as adequate to meet the requirements. We certainly have a good recent track record to prove the correlation of the CQAP with SE outbreaks.

In the interest of time and given the fact that we are becoming a little redundant here, I will just make a few comments, just one or two.

To note that the cost of complying with the FDA rule might not be equitable across the nation due to the size of flocks, the number of buildings, lab fees, et cetera.

For example, we have a large inline facility at Riverside County, which is made up of over 50 individual houses. We believe that tests should be performed in flock pool samples, which will not be as cost prohibitive, but still yield meaningful results.

We conduct SE testing at the chick stage, which is ideal to prevent a group of pullets from entering their lay houses in an infected state. Also, at the end of a flock's laying cycle, we can test and obtain a good idea of the flock's history with less disruption and the necessary information for a clean out.

Also, we have a concern that lab capacity may not be great enough if very many flocks have positive environmental tests. This was a startling lesson we learned during the Newcastle episode in California, just how much state and federal labs are able to handle of these types of issues.

The cost of implementation, as described by the FDA proposal, is significant and may not give us statistically superior results, compared to what we already have. If the $80 million is a fair estimate, our portion--for example, our company would be 1.1 million. In fairness, we have already incurred these costs in implementing our biosecurity through the various programs. It is a significant cost.

Testing and diverting would be a challenge. We believe that prevention by establishing a quality assurance plan and recordkeeping similar to CQAP is a more effective and less costly approach.

Our company operates two FSIS breaking plants in southern California. There are only a few more in the entire state and, in fact, the entire west coast in terms of suitable breaking plants. Most of us operate at full capacity. I can't imagine the logistics of handling all production from a large, diverted flock, something we will have to address, certainly, in the program.

The cost of down grading eggs from the fresh shell egg market to breaking stock can be as high as 20 cents per dozen or more during other market levels during the year. So, there is a significant margin difference in a fresh shell egg for the market versus one that is diverted, even internally, obviously, for us to sell to a major retail customer versus having to divert that to one of our two breaking plants to be sold as manufactured product.

In conclusion, we believe that the existing practices here in California and other areas justify the continuation of our programs without the costs of additional regulations. Our joint industry and government plan as well as our customer requirements more than meet the needs of good food safety.

We thank you for the opportunity to present these comments today and we look forward to working with you. Thank you.

DEPUTY DIRECTOR CARSON: Thank you.

Any additional--yes, sir?

MR. OLDENKAMP: Good morning.

My name is Mark Oldenkamp. I have been involved in egg production for nearly 25 years. I am currently the Vice President of northwest operations for Valley Fresh Foods, Inc. Valley Fresh Foods has produced and graded eggs for nearly 50 years with operations in Oregon, Washington and California. Today, I'm speaking on behalf of our company as well as the Northwest Poultry Council and the United Egg Producers, where I serve on the board of directors.

A significant percentage of the egg industry led by UEP's efforts has voluntarily participated in the development of egg quality assurance programs. I served on the charter committee for the development of the well-respected California Egg Quality Assurance Program you have heard a lot about today. This program was recognized with Vice President Al Gore's Hammer Award, recognizing cooperation and partnership between federal and state government and the California egg industry participants.

Most programs already have requirements for environmental monitoring and these programs have evolved with enhancements in areas that are appropriate and prudent. Our company, along with industry partners, has led the way in the development of equivalent programs for our operations in the northwest. For several years now, all of the egg producers in Oregon have been certified by the Oregon Department of Agriculture, under the Oregon Egg Quality Assurance Program, which was modeled after California's program.

Most companies in Washington long ago subscribed to either the UEP program or have voluntarily adopted the California-like plan. Voluntary egg quality assurance programs have been credited repeatedly with having played a significant role in the reduction in disease outbreaks related to eggs. I personally believe that mandatory third party auditing of EQAP compliance is an important part of the better plans and would urge you to consider the value of egg quality assurance programs with third party auditing as the equivalent to this additional proposed regulatory burden.

Our poultry health team evaluates the total bird health program, including Salmonella risks. I know that every egg producer considers bird health the primary goal of their business, because flock productivity is such a significant factor in our potential profitability.

The science of Salmonella vaccination has sufficiently been documented so that our company and many others have incorporated vaccination strategies. Our vaccine suppliers confirm that, increasingly, egg producers are including vaccination in their Salmonella control strategies and I feel this should be encouraged.

This is not the only part of a good program, but it certainly can be a good tool to reduce the already low risks of infection. Producers that include vaccination in their risk reduction program should be given credit for this effort and investment.

In animal agriculture, there likely will never be anything that will provide 100 percent security regarding SE infection nor protection from other poultry diseases such as AI or Newcastle. I believe our industry has already worked hard on this issue and that the success that is measured by others is evident. Let's not add another layer of regulation where existing programs have already demonstrated effectiveness.

Effective biosecurity is never more important, as emphasized with the recent disease challenges in the west. Our company is not alone in having invested significant additional resources in the area of biosecurity. I believe the industry needs to be able to make good business decisions about the level of biosecurity needed in different areas of the country and not have programs mandated to a non-practical level.

If this program is implemented, it appears that there will be considerable additional costs. It appears clear to me that existing programs already have people on the ground monitoring our industry. USDA plays a significant role in monitoring egg processing already and this existing resource should not be duplicated.

For the additional environmental testing, staff time and laboratory support to provide this service likely will be significant. In many cases, state programs and people are in place to provide necessary monitoring. While the current level of environmental monitoring with pool sampling is manageable through existing labs, we should not create a system that taxes the available resources.

No matter who pays the bill, we should not add unnecessary costs, especially those that could be considered duplicative to existing costs. For companies that have already committed to programs that have reduced the risk of Salmonella in eggs, the analysis of benefits of this regulation could be clouded. Some would argue that they would like a level playing field, so that all would incur similar costs related to risk reduction.

Well, I can support this line of thinking. I would hope that those that already have made the investment can be given credit where it is due. Let's not duplicate programs by implementing new rules where programs have already demonstrated effectiveness. For those that need to get on a program, this is likely the stimulus to close that loophole.

Egg refrigeration under certain time and temperature relationships is important, as demonstrated by science. Ungraded eggs should be refrigerated within a reasonable period of time and graded eggs, soon after packaging. It is true that cold eggs subject to warm water washing could be subject to thermal checking. I believe reasonable flexibility in this area of ungraded refrigeration, such as, for short distance transport should be allowed.

For those desiring longer term, on-farm storage, refrigeration should be required.

While this program deals extensively with the production of eggs, it is silent on the area of food handling. I believe that there are many instances of food handler caused illnesses that this program does not address. It may well be that the need to focus on food handler opportunities is greater than the need to focus on egg production, largely due to the significant progress the egg industry has made through voluntary programs and commitment in recent years.

I'm not suggesting that the egg safety action plan should not move forward, but would suggest that critical opportunities exist in food handling also.

Thank you for the opportunity and we look forward to working with the FDA on this.

DEPUTY DIRECTOR CARSON: Thank you very much.

Are there other comments?

[No response]

 [Closing Remarks/Adjournment]

DEPUTY DIRECTOR CARSON: Let me--just as I listened to all the presentations, I really appreciate all the thoughtful comments that have been made. I would ask for you, as you are preparing your written comments to the FDA, to also consider two points, which I did not hear.

There was a concern raised, a substantial concern raised about capacity concerning diversion when there are positives. I would ask you to consider what are you doing today? If there is a positive environmental test, what are the steps that you are taking today that don't already overwhelm the system? Please inform us so that we can better understand that.

It may be that your testing is done after the flock is in production and there is no negative impact on that egg production. But we would like to have some clarification. I believe the California Quality Assurance Program was going to be provided to us in its entirety and in its currency, so that would help us understand that a bit better.

I think the other thing was, there was a great consensus, I would say, in comments of your support and adoption of the California Egg Quality Assurance Program and other quality assurance programs. And that those should be, in your terms, certified or adopted or considered equivalent by FDA. I would ask, if FDA were to consider such a proposal, would the data and/or the data and production of those systems be shared with FDA on a regular basis? How would you consider FDA auditing those programs so that FDA can have the assurance, in addition to the states and the egg producers?

Consider that in your comments, because our goal and mission is to have a national program that can assure consumers of safe egg products and eggs. If you are putting forward that your egg quality assurance program already does that, how can that be part of an FDA national program, rather than having 50 individual state programs of which FDA does not have any connection across all of those?

Lastly, it was mentioned quite often concerning the economics of the rule and the costs of the rule. I believe we tried to lay those out fairly exquisitely in the rule itself. But suffice it to say, if the California Egg Quality Assurance Program does already include steps that [tape interruption] then you would not incur those additional costs, because you have already incurred them now. So, you would only incur costs for those steps that are not in place.

We tried to explicitly state that in the rule. We would appreciate comments from you as you submit them that show where you do differ or where our proposed rule differs so that we can better appreciate what you are saying are the additional costs that you would incur by implementing this rule.

Lastly, we do appreciate and we do recognize that California's efforts, as with other quality assurance programs around the country--I think Dr. Lynch's presentation, Ms. Bufano's and ours, we all recognize that those quality assurance programs have made great strides towards reducing SE illnesses and/or deaths. Our purpose here is to have a national standard across the board that all consumers, no matter where they are consuming eggs, can be assured that their egg products meet the same standards, no matter where they are consuming them.

So, that is our goal. I do appreciate your comments today and thank you very much.

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