So I think that's something we're struggling with, and I won't tell you it's simple, that everybody's just doing 100 percent perfect. But I think we are working, and I think as we go each month, each year, I think we're going to learn more and more of how to put that in place.

I think we really do have potential for 100 percent participation. And, again, I think the marketing of eggs, not only in California, but across the country is going to make that happen.

We've completed education and training for over 250 people; that includes both government people and industry. We've all sat in the same training sessions. Our veterinarians needed a lot of information so they could understand how to validate these programs. As I mentioned, we're in the process of putting some videotapes together.

We have a certification process which our Department is responsible for, to verify the records on the ranch and as I mentioned, document any corrective actions.

We've got the support from industry on the continued research, which I've already touched on. And, again, I think I've touched on most of these points already in general comments.

But this really does provide the infrastructure for cooperation, communication, to share information. When we do discover something new that might work we want to be able to transfer that information or technology to the industry as quickly as we can. I'm not going to spend any time on the partnership agreement because Ray's going to cover that.

Microbial monitoring and testing. I think we do not currently mandate that in our program. I think if our program would have come together in the last year or two there's no doubt in my mind that would have been mandated.

The ideas for the program originated about four years ago, and testing was a very sensitive issue with the industry. They made a decision at that time not to include it. I will tell you, though, that I think the majority of the industry today is kind of pushing the committee to make this a requirement of the program. And I will tell you that most of the companies are monitoring. And we're trying to educate our companies today that if you are not monitoring your flocks, you're running a huge risk again, given the environment. And we're really trying to convince the industry that that is the right thing to do.

We do get hundreds of samples through our laboratory system, in our diagnostic system every year. And so we know most of the better companies are doing a lot of monitoring.

I guess I'd just throw out the question: are human cases truly a measure of success of a on-farm program? I don't know. I just throw that out for thought. It's going to take some time, I think, to get all the components in place to answer that question. Now, we're looking for risk reduction strategies. We'd also like to see those same risk reduction strategies throughout the rest of the food chain and not just at the farm.

In our opinion, voluntary programs work very well, in fact, I think sometimes better than just passing a law or a new regulation. Because you really do develop that ownership and commitment of the industry that's involved.

So, with that, I'm going to ask David Goldenberg to come up and make a few comments from the industry perspective of the program.

Thanks a lot.

Mr. Goldenberg
David Goldenberg
Facilitator, CA Egg Quality Assurance Program

First of all I'd like to say that I'm very honored to be here and speak before this distinguished group of individuals of State and Federal regulators.

I'm going to give you the points of view of industry and a facilitator sometimes match and sometimes they don't. It's been a very exciting, sometimes difficult, but also sometimes very flexible experience to be in, caught between a rock and a hard place, or as someone told me, between a dog and a fireplug.

I'd like to say that when we first started this program, California was the number one egg producing State. Ohio is number one now. And we are number two, which has been probably a hard pill for us to swallow, but nevertheless we carry on.

I'd like to make a correction before I begin with Rich's Statement about refrigeration. Actually in the beginning of 1998, in January we're going to have two refrigeration requirements that are going to be put into place. One is for the egg processors, which requires that once the eggs are put in a carton they will be refrigerated at 45 degrees ambient temperature. And that is going to be a State regulation.

And also, at the same time, there's been a regulation on the books that was passed a number of years ago, and will be implemented in 1998. That's for the retail side. Eggs, once they hit the retail stores, have to be held in refrigeration even in the back room.

So as of January we're going to have the full continuum covered here in California. I’m going to probably cover a little bit of the same things that Rich has, because I wasn't sure exactly what he was going to say. And I think I need to come back and hit some points and make sure that they're covered fairly well.

Probably the most important reason why the California Egg Quality Assurance Plan has been successful is because everybody who has been involved in the program wanted it to be successful, from the producers to the regulatory community to the University of California cooperative system. Everybody that's been involved here has taken a very positive approach in making this a success. Nobody came into it trying to dodge it, to submarine it. Everybody came here with the highest aspirations to make this program a success.

And also it's successful because there was a perceived need to solve a problem, but nobody had all the answers, and so the collective thoughts were the brainchild of pulling it all together. So, to the system, producers and also finding solutions were the overriding concern.

Also, I think it's been alluded to in the past, but I want to point out that relationships, people were the driving force. Building relationships amongst industry and government replaced there being on two opposing sides, one not understanding the other. Putting them in a group and putting them in a room together, locking the door, and coming out with solutions was the most important factor.

We took regulators or agency people on the farms to show them what's being done, so they have a good understanding of what the industry practices were, what's acceptable, what's not acceptable, what can be accomplished, what can't be accomplished. And they also know what can be accomplished over time and what needs to be done immediately.

So I'd say that the Egg Quality Assurance Plan was built on trust.

You also need to get a buy-in from the industry. And I believe that as the facilitator — and this is a hard part to say — you almost have to be humble about yourself. But I think the efforts of laying the groundwork early on by going out to the industry, explaining what was going on, what was happening on the horizon in the regulatory community and in Washington, and seeing the storm coming, the industry sat down and said we need to do something.

So I think laying the groundwork out for the industry to understand what was coming down in the future brought them to the table.

Marketing pressures also helped build interest. With the Jack-in-the-Box and Food Maker, and the relationship with Von's, a number of supermarkets were beginning to take a strong look at all their suppliers to make sure that all the suppliers have a quality assurance plan in place. And that market pressure then went back to the producers.

And then you have peer pressure amongst the producers. In fact, some of our larger cooperatives and packing plants that buy eggs outside of their own production were putting into contracts that they have to be a member of the California egg quality assurance plan. And believe me, I started getting calls from producers that I never heard of, that I never even knew that were out there, saying, I got to get on this plan, what do I got to do to get on there. Come one, come all, we'll show you the way!

Also, it's important to get a strong industry chairman or chairperson. The group needs somebody who understands, who's well respected, who is a key player in the industry, and who has made a commitment to this. It takes a lot of time and a lot of energy for them outside of the daily work pressures to make this program a go.

But probably most important, and Rich alluded to this, is that economics play the major factor here. It's great that we could show them all the great things that could be done, and should be done, but it has to make economic sense. In fact, that was one of the glaring things that came out of the very early on when we went out to see if there was an interest in coming up with this program.

In California we have high labor costs, we have high land costs, we have to truck in or rail in all of our feed. We're at an economic disadvantage when it comes to the cost of production.

But what we have here are the markets. And so there's a tradeoff. It's almost a balance of the added costs versus the eggs that need to come in from the Midwest. So, it's about even.

The producers here were willing to take on additional costs as long as they weren't economically disadvantaged too much, and so that it would not make it too high a cost to produce eggs here, and then have eggs coming in from the Midwest.

We also wanted to make sure that we weren't putting up economic barriers to eggs outside of California. There were some producers that probably early on wanted to build a shield saying, "Only buy California eggs" because they're under this Egg Quality Assurance Plan. But, we were able to keep that from happening.

On a lighter side, quite frankly, I'm amazed every day that the program has lasted this long and this strong. We began this program three years ago as Rich mentioned, every time we have a meeting we get more and more people attending our sessions, want to find out what's going on, and how they can all participate. So, the interest is strong. And, in fact, almost equate it to the O.J. Simpson trial, where there was like cottage industries that sprouted from the trial. Where you had all these different talk show hosts and everyone was analyzing and strategizing on that trial.

Well, with our Egg Quality Assurance plan there are people coming out of the woodwork trying to make a living off quality assurance, and they're going around and helping producers do some of their validation or they're helping them try to set up their flock plans, or to do on-farm sampling.

So, this is expanding into a larger and larger program. And as Rich mentioned early on, we tried to figure out: How do you measure success? Is it the number of people that have gotten sick, or the reduction in the number of people that have gotten sick? Or the number of farms that are involved? I suppose we're taking a look at all that.

It's hard to say exactly when we're going to be successful, or how you put a measure on that. But I think time will tell.

From an industry point of view we hear about science, and obviously I think some of our producers say, whose science are we talking about. And that fully hasn't been resolved.

As Rich also mentioned early on, we stated that there would be no testing. And quite frankly we never really did incorporate testing. We do have something now where we've fallen back on a double-blinded prevalence test and a validation test to see what our levels are at the farm. But on a double-blind basis you're not singling out any one producer or any mandatory problems.

To the economics. In the Midwest or East Coast, because of problems they divert their eggs to pasteurization. A lot of the farms in those areas just geared for pasteurization. So if they have a problem with one particular flock they can switch and the problem eggs go to pasteurization.

Out here on the West Coast, that's not an option. We don't produce eggs just for breaking. The breaking is the subsidiary of trying to deal with some of the under-grade eggs. So, the economic consequences to producers that have a problem are much greater here than they are in the Midwest.

Rich talked about confidentiality. That was an important factor in bringing producers to the table. They didn't want to be singled out in a voluntary program for having problems, or having liability problems. So having the farm, keep all the record there, and out of bounds from the Freedom of Information Act requests, was very important to bringing producers to the table.

Rich also explained the education program. I believe we are the only State that has a mandatory education program tied to their quality assurance program. We went for the five different areas in developing a HACCP plan and flock plan: C&D (Cleaning and disinfecting) and Biosecurity, Flock Health, Egg Processing and Vector and rodent control.

We tape those educational sessions and we use those tapes to further educate and make sure we get people that we didn't catch the first time around. Those tapes are long, and quite frankly they're also boring to watch, because just like here, you got to sit furthest from this presentation.

And our producers thought the same thing. Well, I had to sit by it, let the next guy sit through it. Well, we're trying to take a little different approach. And not everybody can make it to those sessions, and not everybody can spend the time to go through and watch 20 hours of videotape.

So we tried to take the show on the road and tried to make it into an interesting and lively discussion. And we got some funding from USDA and from CDFA to try to compile it. And there wasn't much known about rodent control. So we took our rodent information, which was about three and a half hours of tape, and boiled that down into about 40 minutes of professionally cut and produced videotape.

So when we talked about rodents running along wires to get from point A to point B, or from jumping a distance of about oh, three feet, four feet, we showed it on videotape, and brought to light what the problems are. And showed them in an entertaining fashion. We made it into a Sherlock Holmes case.

You have a problem. You see the destruction. You see evidences left behind. Who's your perpetrator? And you put together the pieces and you find out who your perpetrator is. And if you know who your perpetrator is, then you know how to attack the problem.

So educating them to know what they're doing, to applying their knowledge, and also record-keeping are a very important component.

Our goal is to take these videotapes and also translate them into Spanish so that they can be used on the farm to inform those caregivers of what their role is on the farm and towards food safety. We have to get buy-in from the top to the bottom, and where the tire meets the road is with the caregivers, and they are our most important link. And unfortunately we don't get to see them all the time. In fact, they never came out to be educational programs.

We got owners, we got high level managers, or mid-level management. So bringing that message to the farm and trying to boil down the 20 hours of educational time into the short videotape is a most important task. We competitively went after a grant and we got the funding for that. We also got funding from Bayer Corporation to assist us as well. So we have private and government support in trying to develop these educational tapes and programming. And it's going to hopefully go beyond California. We want to make them available nationwide to anybody that wants to participate and have this information available.

Ray's going to talk about the partnership agreement. I think that's a hook that we need to have to get industry involved. They need some incentive. There's economic incentive, but they need some incentive from a regulatory standpoint to know how they're going to be treated and to know what the rules are. I think knowing the rules is the most important factor, so the rules don't get changed on them in midstream.

In regard to outbreaks, we've had a few. I think from industry’s point of view, you always feel that they are always being looked at as the guilty ones, and that the government’s point of view is that it is easier to control 600 egg producers nationwide versus 6 million food handlers. I think that both areas need to be addressed at the same time.

And I think government needs to come to the industry and say, all right: "We're going to participate. We're going to do our part. You're going to do your part. And we're going to explain and educate each other on what we're doing so that everybody's informed and doesn't feel left out."

Some of the positives I feel is that the industry needs to feel like they're making a difference. And that's an important goal. It's a win/win situation. It's win/win for the agencies and win/win for the industry and consumers, as well.

We need to keep everybody involved. Everybody likes to give advice. And we ask people for advice. We don't tell them. We ask them; we ask their advice. There's a lot of pride in this program, a lot of State pride, and that's very important for our people here.

As I mentioned, relationships and foundation are very important building blocks in developing trust.

We had FDA people from Washington down here last December viewing our egg quality assurance plan. We took them around to some of our better producers, we took them around to our not so better producers. We showed them farms that had been on the program for quite some time, farms that were just beginning to get on the program.

The farms opened up their records, and they were very candid with these officials. The FDA’s officials went in and they made a lot of good points, and they asked a lot of questions. But when it came down to it at the end, I think they were very impressed with what was going on out here, and the amount of record keeping we were doing.

So I think from an agency and industry standpoints, we'll probably always have some issues of disagreement and maybe we can't get them all solved, or maybe time will take care of that. But first we come together, and we begin to learn more about each other's positions.

Unfortunately politics hurts. I think politics and science do not match, do not mix very well. And we have to be sure to remove the politics from these voluntary programs if you want to get participation. Obviously, these are family farms. They take it very personally. And when they are being scrutinized, they don't like what they feel are personal attacks on their production practices that they have grown accustomed to, and even more, problems that are beyond their control.

Regarding some of the problems that have been encountered, I think Rich probably stated and hit it right on the head, there haven't been very many. But probably, lack of record keeping has been the highest concern. We have companies that have a lot of personnel and they're very good at nitpicking and keeping a lot of records; and with those producers, we don't have a problem. But some of our smaller producers, the family, small family farms, the one person that is their quality control supervisor, who is also the sales agent, he's production, he's everything. And it's hard for these farms to keep all their records down on paper. A lot of records are up here, but that doesn't help, especially when we go back and want to re-validate or make sure the producer's following along.

So, I think record keeping is probably our greatest challenge. And one of our USDA officials stated it so eloquently when we were going through our educational process. He said, "If it's not in writing, it hasn't been done." It may have been done, but if it's not in writing, it hasn't been done. So we try to get that point across.

As the role of the facilitator, I think having the trust of both government and industry has been the success for this program and helping this project move along. You have to have knowledge of the industry and of the industry practices.

Rich wanted me to go into some of my background. Before coming to California, I was in Indiana. And in that job I held a dual role as a regulator and as an industry representative, which was unique. And I really don't have enough time to go into it. But knowing that the regulatory side, working with USDA back when they had the SE control program, knowing how things operate I was able to take that information to the producers, and then take the information from the producers and educate the agency people, as well. So that there was a good cross-knowledge going back and forth.

And having that clear direction of where we wanted to be, I moved along the industry groups so that we made progress time and time again.

It took a lot of time to coordinate meetings, mailings, building a database, and just talking, talking to people and keeping communications open. In private, with industry, or with the agencies, we could speak and be open.

And I suppose, the facilitator is the essential person that everybody looks to coordinate and make sure that everything is going along. But I think that it's being sincere in the genuine belief that you're doing what's right for everyone has been the motivating force and factor, and making sure this program is successful.

Thank you.

Mr. Nelson
Raymond Nelson
Food and Drug Administration

Well, good morning, and I know it's almost lunchtime. And I can see a few of you fading out there. So, I'm going to divert just a little bit aside from talking about the eggs, to talking about partnerships. In California and Arizona, we have 13 different partnerships, the Department of Ag in California with the Salmonella enteritidis with eggs. In Arizona we have partnership with their Department of Ag on pesticide residue collection and the other things. We have a partnership here again, we'll mention that, with CDFA where we accept their data and we provide other information. So we have a lot of different partnerships going on.

You have formal partnerships, which I'm going to talk about here, where it's a written document and we've all agreed what we're going to do, et cetera.

There are also a lot of informal partnerships that we're going to talk about later on, concerning strawberries, sprouts, Western Growers, lettuce, and Apple Hill. Those are informal partnerships where we're committed to working with industry and States.

Anyway, but those are informal, and this is supposed to be a partnership discussion and so far I haven't heard anybody ask anybody any questions. I don't know if that's forbidden here or not. Question and answer sessions are what you really need to have with partnerships. I got involved in the egg quality assurance program by accident. We had a program picking up eggs for pesticide analysis and poultry bacterial counts. We sent a couple of investigators to the San Bernardino/Riverside area to pick up eggs and chicken feed, and they arrived at a couple of farms and all of a sudden the farmers end up calling Dr. Breitmeyer. They were upset because FDA was there collecting samples.

Dr. Breitmeyer called the now-retired Regional Director, asked him what was going on. He called my boss, the District Director, to ask what is Los Angeles doing. And they said, well, it's probably Nelson doing something.

And so a few days later, I was in an egg meeting in San Bernardino County. Upon walking in, I found a person who's now retired, but was someone I went to college with 30 years ago, and was at that point, I guess, the second major producer of eggs in California. And so from that point on, I have been visiting egg meetings for a long time.

And after we had a few meetings, over a few months, it was evident that a partnership would be advantageous. This is not something you just sit down and write a partnership and say we'll sign that thing, go from there. It takes months to write a partnership. Sometimes it takes years to get one.

But if you'll notice on this one, it's not just one agency. It’s members including the Quality Assurance Program, the egg producers; CDFA; USDA; California Health Services and FDA. Now you're taking about all those people, sitting around a table. You try and get everybody to agree on one document. Sounds easy, but it isn't.

You hope personalities don't get involved. Sometimes they do, but then they back off. We have some rather lively discussions, most meetings are parties. You bring the egg industry in and you have a room this size, and you have 80 to 100 people there, something like that, a lot of them. And you start talking about trace-backs. And it can get to be pretty lively.

You start bringing in health services from different counties in; everyone has a different opinion. It took us about 18 months to actually formalize this partnership.

As David mentioned, we actually had the partnership done. We brought people out from the Center for Food Safety and Applied Nutrition (CFSAN of FDA) out of Washington, and we visited the farms because these same individuals had been in the Midwest and other areas where they had quality assurance programs and they would go out to the farm. And what would they find? Yeah, they had a document sitting on the shelf, dust on it, never been used. And they were of the opinion that the documents here in California were the same type of documents sitting on someone's shelf that had never been looked at.

They had their eyes opened, when we started visiting in the southern California area. The first plant we visited wasn't even on the program yet, but they were working on it. And we looked at what they had. We worked our way through the State.

And by the time we got done, the CFSAN visitors were very impressed. They were also very impressed with the training program that was put on here in California. I've had requests since this partnership has been formed from a number of other States looking to create a partnership. They're also looking at using the California plan for quality assurance programs.

Before the California quality assurance program was here; everybody was doing their own thing. And since the program's gone into effect roughly 85 percent of producers either are on the program or are getting onto the program. So that's a lot of eggs being produced; it's a real advantage.

One critical output of these partnerships is commitment. Commitment is something you have to have in any partnership. If you don't have overall commitment by everybody and spend a lot of time maintaining it, your program is never going to work.

Also you have to sit up front. Whoever is going to be doing the work has to have free rein to do it, and to be working on it continuously.

Yesterday, we had a meeting for over three hours with the regulators here discussing price facts. And it was a very pleasant meeting, and we sat around here, we discussed things. Everybody had their opinions. But we were able to sit there and talk for three hours and have good communication. We've had three trace-backs recently in California for eggs. So we discussed each case. We went over how can we do things better, and where can we go from here. And we reached a mutual consensus. Maybe not everybody was perfectly happy, but at least we have a consensus of what's going to happen.

Quality assurance programs bring an awareness to the industry, to the government agencies, all involved, in what's going on, and the biggest thing for the egg industry. All of a sudden they realize that there's Health Services that is involved, the FDA's involved, regulatory.

And if there's a trace-back all of a sudden, say the FDA shows up and does the whole thing. We didn't notify the Department of Ag, we didn't notify Health Services under the old system. Here we have a trace-back, everybody's notified. Everybody shows up.

On the three trace-backs we had a team effort. We all showed up, and we all, you know, worked together as a team. We picked up in one case almost 500 samples, marvelous samples were picked up, 4000 eggs. We divided those up between the different laboratories, and we shared all the information. We shared the reports. We went back to the farm and talked to them. So there's a lot of benefits in quality assurance plans and partnerships.

This particular program has been nominated for Vice President Gore's Award. Hopefully that will be issued to us sometime next year. As far as I know this is the only partnership in the country right now where you have industry and four government agencies involved in it.

When we first started it I didn't think we could ever get everybody to agree upon it, but we did, and it's working quite well.

Any questions?

Thank you. That's pretty much all we're going to cover this morning. I appreciate your listening to these examples.

One comment. I know many of you are from the meat and poultry side, and look at the schedule this afternoon and say, well, gosh, I don't need to go to a bunch of vegetable and fruit talks. But I will

encourage you to keep an open mind and remember that many of the emerging pathogens and bugs we're talking about do have their source in our animal species, and I think there really is a very good link — not good, but unfortunately, but there certainly is a link between certain animal products, animal waste, manure issues, environmental waste issues with some of these products, as well.

So I would encourage you, the lessons learned, I think, are transferable to whatever program you're working with.

I'm Bonnie Buntain from FSIS, Animal Production Food Safety Staff, and my name's been mentioned in case you people don't know who I am. For the record, I want to say that some speakers have noted support from the FSIS program, which I am fortunate to direct. And that is the Animal Production Food Safety Staff.

And I want to thank the speakers for recognizing FSIS' support for seed moneys for these partnerships. I think it's an example of how Mr. Billy and FSIS are committed to promoting State-based, grassroots team initiatives.

So I just want to recognize and thank those speakers for recognizing FSIS' support in these areas.

Yeah, I would echo that. I've had an enjoyable relationship with Bonnie for many years working on these issues. Her staff have been extremely supportive, provided a lot of both financial and very strong encouragement. We really do appreciate that support.

A couple — one quick thing, we talked about is our educational program. This is an educational binder for egg quality assurance program. I'll set it over on the table. If any of you want to

take a look at it. These cost about 25 bucks to put together, and if I only get a couple requests I'll be happy to send a couple out. But if I get a lot I'll have to charge you for them. So if anybody would like those.