President's Council on Food Safety

U.S. Department of Agriculture	Department of Health and Human Services	Environmental Protection Agency	Department of Commerce

Place:
Federal Hall
Washington Plaza Hotel
10 Thomas Circle, N.W.
Washington, D.C. 20005

Date: Wednesday, January 19, 2000

PARTICIPANTS:

(8:45 a.m.)

DR. WOTEKI: Good morning. I'm Cathy Woteki, and I would like to welcome all of you to this meeting. As you know, it is being held under the auspices of the strategic planning task force of the President's Food Safety Council. And that council was established to strengthen and also to focus food safety policy and resources in this country.

As one of its major tasks, the council was directed to develop a comprehensive federal food safety strategic plan. We who have been working as the strategic planning task force have about six months remaining before we have to deliver our final document to the President's council and to the President in July of this year. This has really been a very challenging and multiagency effort, which I think reflects in many ways the complexity of the challenges that we face in ensuring the safety of the American food supply.

The task force felt that the plan has developed to a point where we needed to hear your views, and essentially to step back from the work that we have been doing so far and to hear your views. That is why we are here today. And I think we all are going to benefit from the sharing of those views.

Now despite the confidence we have in the safety of the food supply today, we are still confronted by a significant number of cases of food borne illnesses in this country. I'm sure you are all aware of the recent estimates that the Centers for Disease Control have provided and which have also been very helpful to the strategic planning task force. However, there are more microorganisms and other hazards continuing to emerge, and some intractable problems continue to cause illnesses.

So one of the tasks of this plan is to ensure that the food safety system continues to evolve to meet those old as well as new challenges. At the same time, nearly a quarter of the population is particularly at risk or susceptible to food borne illnesses. It is also important to develop a comprehensive and forward looking strategic plan to ensure the safety of the nation's food supply into the 21st century. And as a result, the task force that Dr. Henney and I are cochairing feels that this is an extremely important meeting in the development of the strategic plan and in the directions that that plan is taking.

Your contributions to the dialogue today, and we hope over the weeks to come, are critical to enriching a plan that will provide an effective system capable of responding to and preventing food borne illnesses and hazards.

Now many of you here today also attended the last meeting of this task force, public meeting of this task force, in July of 1999. And I hope that you will see that there is very -- there are very substantial differences in the plan that is under discussion today from that one that was made public in July. It now contains three goals that are framed around risk assessment in science, risk management, and risk communication. Each of these goals is accompanied by a narrative, objectives, and action items that are intended to achieve the goal.

These changes are a result of the many very substantive and thoughtful comments that were received at the July meeting, and also many of the written comments that have been submitted after the meeting. We expect that this meeting today will help us to refine the strategic plan even more.

Now I would also like to point out that the task force is doing a more comprehensive examination of legal authorities as part of its strategic planning effort. That examination looks at a variety of proposals and may result in legislative initiatives that go beyond the current proposals. The administration has already asked for more legal authorities to strengthen our food safety statutes, particularly in the area of recalls and civil penalties. We would welcome comments during the meeting today as far as views of what are barriers in legislation to attainment of the goals and objectives of the strategic plan, as well as potential statutory changes that you view would be meaningful and helpful additions to the current authorizing statutes.

Now before we talk specifically about the format for today's meeting, let me introduce two people who have played extremely important roles in the work of this task force. The first is my cochair, Dr. Jane Henney, commissioner of the Food and Drug Administration at the Department of Health and Human Services. And she will be followed by Ms. Susan Wayland, who is deputy assistant administrator for prevention, pesticides, and toxic substances at the Environmental Protection Agency. They would both like to make some opening remarks. So we will start with Dr. Henney.

DR. HENNEY: Well, let me add my words of welcome to all of you here today in our latest series of public meetings. We have enjoyed very, I would say, both broad and deep input from the community in terms of our task force's work to date, and we look forward to what this meeting holds for us as well.

I think I would like to underscore a few points already made by Dr. Woteki. I think we want to make sure that we emphasize how much your comments meant to us last summer because it was based on many of these comments and concerns that we really stepped back, evaluated the approach that we were taking at that time, and really redefined many of the specific goals of the plan that you saw in the summer.

In addition, we have added more detailed objectives and action items to flesh out some of the steps that might be taken to achieve this plan's overarching goal, which is really protecting the public health by reducing food borne hazards. It is going to be not just important to us, but important to the work that we all do in protecting the nation's food supply to make sure that we here enact on the public input on the direction and focus of this plan as we further define the specific elements.

Again, you know, as we are working under a vision statement that was developed some time ago, and I have already stated our overarching goal with respect to public health, but we are working now within the constraints of three goal areas, in science and risk assessment, in risk management, and furthering our efforts in terms of risk communication. We believe it is integral to not keep these -- although we want to discuss each of them separately, we also need to see the linkage and integration between and among all of these separate goals because it is only if we are able to do this that we will really achieve our vision for public health and food safety.

We want to make sure that we get responses to some very specific questions. In particular, are there issues or specific tasks that are not identified that you think should be part of the strategic plan. Another question that we have is we have identified priorities and chosen action items that we believe will result in a real difference to the public health, but we need to hear from you as to whether you believe the same in this regard. And I think we also need input from you in terms of how we move forward together to increase the food safety and protect the public health in the United States.

There are a number of other questions that I think have been posed to the panel that were also raised as we issued this public document that Dr. Woteki may be going over once again. We want to listen to all of your responses, your thoughts and concerns about the plan to date. Each of our agencies, the FDA, the USDA, and the EPA, have opened a public docket that will allow people beyond this room to have their own input into this process. And the docket will remain open until February 14th of this year. So as you or others that you know have thoughts and concerns that you want to raise post this meeting, please feel free to do so.

Another reminder of something that has been said, we intend to meet that deadline that we have been given in terms of issuing a final report and strategic plan and providing that to the President's Council on Food Safety this coming July. We believe that plan will be based not only on what we have done to date but what we hear from you today and what we hear from you in the coming weeks and months ahead.

I want to thank you for your participation. I feel myself one of the most unfortunate in this room because I am not going to be able to be here to hear all of your deliberations, as I have been called to a meeting across town in my own department, which I have been told I must attend. So I will. But I have set aside time so that I can not only review what is said here today, but to also spend some time on that public document as we receive it in February.

I do hope I will be able to rejoin you later this afternoon. I wish you well, and I look forward to hearing all of the discussion, debate, concerns that you have during the course of the day. Susan?

MS. WAYLAND: Thank you very much, Jane. Good morning, everybody? Is my mike on? I can't -- it is hard for me to tell. But I want to first echo Dr. Woteki and Dr. Henney's welcome to all of you. It is truly wonderful to see so many people here, to see old friends and new faces. This is a very important and serious issue, and I think it is terrific to have the number of folks and the amount of support that we have in this room today to help us with our mission.

On behalf of EPA, I want to thank all of you for coming here today to help us fulfill the charge that we have from the President and the council to develop a comprehensive strategic plan that will ensure the safety of the U.S. food supply for years to come.

Food safety is actually a very high priority at EPA. For those of you who have not yet memorized the EPA strategic plan, we do have ten strategic goals that we have articulated as part of our Government Performance and Results Act. And in addition to those areas that you probably think of more with the EPA, like clean air, clean water, healthy ecosystems, safe food is one of the strategic goals of the Environmental Protection Agency.

We are concerned not only about the pathogens in the food supply, but also about the chemicals that may inadvertently contaminate the food supply, and about pesticide and pesticide residues, which, of course, are intentionally added to help us grow the food in this country.

There has certainly been an increased emphasis on food safety at EPA since the passage of the 1996 Food Quality Protection Act, or FQPA. Developing a strategic plan for FQPA and having that plan fit into the work of the council and developing a comprehensive plan for the nation in protecting the food supply is a very big job, but it is a job that I know that we can do. And with your help, I think we will make great progress on that journey today.

The strategy is really a way to focus, all of us, those of us in the public sector, those of you in the private sector, on the important goals that all of us face in reducing food borne illness and hazards. Certainly, for EPA, our experience in working with these other agencies, just as far as we have gotten, has been tremendously valuable. And I think that working with the public has been tremendously valuable already in developing a comprehensive plan.

We know that our work in the pesticides arena, in our implementation of FQPA, has taught us in a very real way how tremendously important and valuable public input is. And working with our stakeholders, working with the states, working with our other partners and with public interest groups and environmental groups, I think it enriches this debate, and will result in a strategy that really does address the challenges that the President gave us.

I am very much looking forward to hearing all of your comments today. I would echo both Dr. Woteki and Dr. Henney by saying that we really are here to listen. We truly value all of the input that you are going to be giving us today. And I really look forward to a very rich conversation throughout the day. Thank you. I'll turn it back to Dr. Woteki.

DR. WOTEKI: Thank you, Susan. Let's now talk about what we are going to do today. I would like to first of all highlight some of the themes that we have identified in the development of this plan. These are more fully discussed in the draft that was posted on the web. But I think they are worth noting as we begin to have a more in-depth discussion of the plan and its goals. And the themes are six in number.

The first is the food safety system must be based on sound science and risk assessment, as recommended by the National Academy of Sciences. The second theme is priorities must be selected based on where the scientific data show the greatest food safety risks. The third theme is objectives and actions must be measured in terms of their impact on public health. The fourth is prevention. Prevention of food safety problems must be emphasized. The fifth is fair and even-handed oversight and enforcement of laws and regulations by the responsible federal, state, tribal, and local agencies is critical. And lastly, we must better coordinate our efforts and the use of our resources.

These themes are important to emphasize in the plan, and are really the threads that kind of tie together the action items under each of those three goals. So as we go through the goals and objectives and action items and further discuss them today, I think it is worthwhile to keep these themes in mind and think of them as measures against which we want to evaluate the action items.

Now for the format of today's meeting, for those of you who have participated in the past public meetings that we have held, and more recently, the one in July of '99, I am sure you can see that there is a change already in the format of the room, just the way this room is set up for today's meeting. Our objectives, though, are the same, to have an active dialogue among all of the communities interested in improving food safety in this nation.

That dialogue is important to create a plan that improves food safety in the United States and serves as a foundation for bringing about what many of us have talked about as being a seamless food safety system from farm to table. Now just in setting up the room today, what we tried to do is to strike a balance between promoting discussion and seating anticipated were going to be 150 participants in today's meeting.

You'll notice that the focal point of the room is this large almost square table. And there are also smaller tables all around the edge of the room. As we move through the agenda, we expect that some participants are going to want to participate more actively in discussion of specific goals or specific action items, and they are perhaps less interested in discussing another goal or set of action items.

So at the beginning of each segment of the agenda, we are going to ask those who have a lot to say to move up to this table, and those of you who are anticipating that you'll have less to say about that goal, to take a chair either along the row of chairs on either side of the room or at one of the round tables.

Everybody, though, will have an opportunity to say something about the goals and objectives, no matter where you are seated, whether it is at this table or away from the table because you can see that there are microphones that are set up all around the room. So if you have something you want to say, just come up to one of those microphones, and we will recognize you.

I would also like to indicate to you all that there are many members of the task force that are here. And as I look around the room, I think most of the members of the task force are here. And there are also many people who have participated in some of the working groups that have developed initial outlines and text and ideas that the task force has developed into the draft document that you see. And I might just ask at this point that all the people who are members of the task force who are here today, if you could raise your hand so people around the room can see who you are.

(Show of hands)

DR. WOTEKI: You might in breakout session or breaks want to approach one or more of these people with an additional idea that you might want them in particular to know.

I might also ask people who are members of one or more of the working groups who are here if you might also raise your hands.

(Show of hands)

DR. WOTEKI: So there are a fairly significant number of people also here who have participated in the working groups.

Clearly, it is a benefit to all of us who have worked on the development of this text to hear all of the ideas. I am really glad as many members of the working groups and the task forces could be here today.

Now let's just briefly look at the agenda. After this opening portion of the meeting, we have asked three people to at least get us started in the discussion about the plan. And I'm going to come back in a moment to introduce those three members of that panel. After the opening panel discussion, we are going to take a short break. And then we are going to move into a discussion of the overall framework.

Now if you look at your agenda that you received when you checked in at registration, we'll see that there are three questions that we are going to use to focus and direct the discussion about the structure of the plan. At 11:15, we'll go from the overall plan to addressing the individual goals with their respective objectives and action items. And we'll just proceed from the first to the second to the third.

So the first is the goal about science and risk assessment. And again, if you look at your agenda, you'll see that there are four questions on the agenda that we would like to use to focus the discussions. You'll also see that one of those questions has to do with organization, the organization of the federal agencies. And we would like as well for you to comment at each point for each of the goals on whether there are certain organizational structures that were described under the list of -- or the paper on options that was included again on the web document as to which ones would help to forward the achievement of the goals and objectives.

And after lunch, we will reconvene at 1:45. We'll have a discussion of the risk management goal, again focusing on those four questions. And lastly, we'll end the afternoon with a discussion of the risk communication goal.

That last session this afternoon will be chaired by Caren Wilcox, who is deputy undersecretary for food safety at the Department of Agriculture, and is seated to my right here at the head of this table, and also by Joe Levitt, if Dr. Henney is not able to make it back this afternoon.

Now I want to make clear that the format is intended to be interactive. We did start this morning with some opening comments. But it is probably going to be the last that you are going to hear from us, other than to ask some provocative questions as we go along. Prepared remarks that any of you might have can be submitted in writing to the dockets that are open at all three of the agencies that are represented here, the Food and Drug Administration, the Environmental Protection Agency, and the Food Safety and Inspection Service, and written comments and information about how to submit written comments was detailed in the Federal Register statement and is also included in a handout that you should have received as well when you picked up your registration materials.

So everyone is encouraged to participate regardless of where you are sitting. We are going to have this meeting transcribed, so we will have a formal record. And when you begin your discussion, it would be very helpful to all of us here if you first start by giving your name and the organization that you are here representing.

Now the first item on the agenda then is to move to the panel discussion. We have asked three people to get us started this morning by making some remarks on the strategic plan. They were selected as in some ways representing the major communities that have an interest in food safety. But we also, when we asked them if they would make some comments, told them that in no way would anyone here be expecting that they were representing completely in any way the views of the communities from which they come.

So I would like to introduce all three panelists, and then ask them to get us started in this discussion. First, speaking as an expert in public health is Dr. Dean Sienko. Dr. Sienko works as the medical director of the Ingham County Health Department in Lansing, Michigan, and he has been working there for the last 12 years in that capacity. From the consumer community is Mrs. Nancy Donley, who is president of Safe Tables Our Priority. It goes by the acronym STOP. And thirdly, from the private sector, is Dr. Rhona Applebaum, who is executive vice president for science and regulatory affairs at the National Food Processors Association, a position that she has held since 1994.

So our invitation to be on the panel was not intended to put these people on the spot for their entire communities. We just wanted them to help get this discussion started. And I want to say we really appreciate your willingness to take on that responsibility. So, Dean, would you like to start us off?

DR. SIENKO: Thank you. As you heard in the introduction, my background is largely in local public health. Some of my comments will reflect that orientation, I'm certain. At one point in my career, my card said medical epidemiologist, and my role was to crunch numbers. Now as a local public health official, I usually try to get my message across by telling stories.

So to help you appreciate my perspective and to put you in my frame of mind, I would like to dissect aspects of the first well studied e. coli 0157:H7 out break that occurred in Traverse City, Michigan in the early 1980s. It began with a nurse, a health practitioner and consumer, who had a child with bloody diarrhea. She talked about this illness with her physician. This local physician noted that there were other cases of bloody diarrhea with a compatible clinical picture. So he took specimens and notified his local health department of this unusual occurrence.

He received the first tier and the rudimentary elements of the public health side of the food safety system, the informed consumer and knowledgeable health care providers who think beyond the clinical illness and relate to public health. If the CDC estimate is that one of three people suffer a food borne illness annually, then where are these people? We see but a sliver of them. We have a tremendous gap to overcome in food safety knowledge among our citizenry and our health care providers.

Finally, when doctors report to the local health department, local, state, and federal disease control investigators worked cooperatively to conduct the epidemiological analysis of this outbreak. They found that hamburger consumption from a fast food restaurant was associated with illness. This was followed by local environmental health staff who worked with the restaurant to uncover a malfunctioning grill that accounted for some hamburgers being undercooked.

Ultimately, this investigation led to the identification of the e. coli 0157:H7 pathogen and a further understanding of this food borne threat.

Here we see the second tier of public health, the professional system, responding to surveillance supportings, conducting an epidemiological analysis, using the results of that analysis to prevent further cases and enhance our knowledge base.

So does the strategic plan respond to these things? The overarching goal does not mention consumer complaint, surveillance, or outbreak response, all key elements of the above scenario, and the public health role in food safety. The plan could do more to promote not only data collection but data sharing. Many argue that the outbreak of the future involves sporadic and geographically dispersed cases of illness. Effective surveillance and real time data sharing will help us respond to such occurrences.

The plan talks about education, but we need to underscore its importance. From consumers to doctors in emergency rooms to public health nurses in local health departments to laboratorians in state health departments, all need the knowledge and capacity to respond appropriately and work cooperatively on food borne illness. The plan gives me hope. It mentions state of the art science based education. Federal institutions can play an important role by developing such educational tools and working with us to disseminate them and to train appropriate audiences in our communities, both public and private, professional and lay.

More informed consumers, professionals, and employees in the food industry will lead to a successful plan. The ultimate measure of success is greater prevention and less human illness. And although the plan is referred to as a federal strategic plan, the President's mandate of safe foods for Americans will require a national effort, and this will require an improved infrastructure, better coordination involving both public and private sectors at the state and local levels.

The encouraging part of this initiative and this plan is that we have consensus on where we want to go, safe food for consumers. This plan offers a beginning for the dialogue on how we are going to get there. Thank you.

MS. DONLEY: Good morning, everyone. I am Nancy Donley from STOP, Safe Tables Our Priority. I would like to thank you for being asked to participate today. And it's a pleasure to be here. I am from Chicago, and I have been kind of entertained by what happens to Washington, D.C. when there is a little tiny bit of ice.

(Laughter)

MS. DONLEY: I am just going to say very, very briefly a little bit about STOP and who we are for some of those who may not know. We are a food borne illness victims' organization, and we represent the people -- our membership are people who have been personally impacted by food borne illness or have had loved ones or family members personally impacted by food borne illness. We also represent concerned citizens everywhere.

My involvement got started with the death of my six year old son from eating e. coli 0157:H7 contaminated meat. And we are very committed to food safety, and we would like to thank the administration and the various food agencies here for their support and commitment to food safety. And we hope it continues and continues to grow stronger and stronger.

I would like to just begin my comments with -- I'm going to be talking some very general types -- making some general observations of this strategic plan. And I would like to start with the vision statement and overarching goal. The vision statement -- and both of these are very laudable. But I have a concern that if the vision statement becomes a publicized statement that the public will stop reading after the first or second lines. And what -- I will just quickly state that the first line says that consumers can be confident that food is safe, and that the second lines says we protect public health through a seamless food safety system that uses farm to table preventive strategies and integrates research, surveillance, inspection enforcement, and education.

It sounds like there is no problem, we don't have to be concerned, food is safe. Then I question where our overarching goal goes on to say that the goal is to protect public health by significantly reducing the prevalence of food borne hazards, thereby reducing acute and chronic illnesses and injuries.

I perceive this as a conflict. On the one hand -- we have got conflicting information here. On the one hand, we are saying food is safe. But on the other hand, we are saying we are going to reduce food borne illness and death. So there is a problem here that I think needs to be discussed and addressed.

I'd love to be able to say that our food is safe, and I think everyone in this room is, and that we don't have to worry about it. But the way this is structured right now, the public will take it to mean that the food is safe when they get it, and therefore it is a no risk thing for them. So I'm very concerned with that.

The second observation I would like to make is that all these goals, I think, are very laudable, but somewhat unspecific. So I would like to encourage the development of very measurable goals with accountabilities built in as well. I think a key point missing as well that I would like to suggest is that there are no timelines right now in this document. And I think that it is necessary that when you set goals, to have it within a structure, a framework, of time and what specifically you want or you can have. It can be a five year and keep narrowing it down. But it has to be measurable within certain time frames.

I also am concerned -- I think again that these sound terrific on paper, but where is the funding going to come from. I don't see anything mentioned in the plan as it currently stands on funding, funding this issue. So I would hate to see all of this hard work that I know the task force has done and put this together, and the commitment that we all have to this, just be a waste of time and effort because the funding isn't there. So I think we need to have some of those specific things addressed.

And lastly, I just want to comment that it is absolutely crucial that what -- where we take this plan, where we take this document, be founded on a very solid foundation. We have to have -- to build a structure and to have all of these admirable goals, you can't just keep piling on and on. I pay my bills by being a real estate agent. And I know enough about houses and structures that if you don't have a good foundation, a solid foundation, a cohesive foundation, one that is fully cemented and there are no cracks, the structure will not -- you will not support the structure of the building itself.

So we have got to have not such a fragmented system. We have got to somehow solidify it and create a solid foundation. So I hope these remarks are -- I hope these remarks are kind of helpful for starting the discussion today.

DR. APPLEBAUM: Thank you and good morning. NFPA appreciates this opportunity to provide comments. The time allotted to me this morning will not permit me to go into detail on all of the aspects of the plan that NFPA supports, as well as those aspects of the plan we feel require more attention. However, you can rest assured that NFPA will be providing detailed comments on those particular issues. In fact, we will be comparing this draft plan very closely to our own food safety agenda, an agenda we developed to guard our public activities in the area of food safety.

Preliminary comparison of our five objectives with the plan's three principal goals indicates we the industry and the federal agencies that regulate us have the same goal, to ensure to the extent possible the safest food supply. In fact, our food safety philosophy embraces the strengths of this plan, a commitment to scientifically sound preventive systems as the key to ensuring a higher level of food safety assurance. Further, we both recognize that food safety is a shared responsibility requiring the attention not only of government but of companies throughout the food system, as well as safe food handling practices by consumers and commercial food handlers.

Our commitment to sound science and risk assessment has been articulated in numerous comments, as is our commitment to research, surveillance, and education. With that said, NFPA wants to compliment on the government on the drafting of a plan that is first and foremost bold and designed to enhance, advance, and build upon strengths currently existing in the agencies at all levels of government and others in the public and private sectors.

Despite criticism we know you will face, the decision made to build upon a foundation that has been successful rather than raising and undercutting all of the progress that has been made is the right decision, and we support your action.

I would now like to remaining time to focus on specifics of the plan, beginning with the overarching goal and framework of the plan. I will address the questions laid out for each goal. Those I don't comment upon will be covered in our written comments.

As I mentioned earlier, NFPA is supportive of the strategic plan's overarching goal, which is to protect public health by significantly reducing the prevalence of food borne hazards through science based and coordinated regulation, inspection, enforcement, research, and education programs. We think this is a well focused and comprehensive plan. NFPA also supports the plan's overall framework, which sets goals for science and risk assessment, risk management, and risk communication.

The remainder of my comments will address the draft goals outlined in the strategic plan, beginning with science and risk assessment. It has long been our position that government resources should be direct toward the areas where there is sound evidence of real risk. This position is clearly reflected in the strategic plan's first goal. In fact, as was mentioned earlier by Dr. Woteki, the draft strategic plan notes that the National Academy of Science's position that, "The food safety system must rest on sound science," is a point that has been repeatedly by NFPA.

We agree with the draft plan's objectives of expanding surveillance and data collection capabilities to better identify emerging and potential high risk food safety threats. We recommend that the council add an action item to expand active surveillance programs such as Foodnet to provide the most accurate data. In particular, we support the establishment of extramural programs to conduct targeted research and develop training programs, especially with regard to using public, private, academic consortia, as this ensures that research and training will be practical and applied.

We also support the strategic plan's objective of enhancing the scientific infrastructure and skills, and improving the coordination of activities at the federal, state, and local levels. NFPA strongly believes that food safety partnerships among federal, state, and local health agencies will only be effective if they are well coordinated. As far as the risk management goal, NFPA has no disagreement with the strategic plan's goal that the United States system for managing food safety is effective from farm to table.

We have no agreement with this goal. We believe that a holistic approach to a well-integrated and coordinated food safety system is vital to enhancing the effectiveness of our nation's food safety system. We strongly support a number of the objectives suggested to support this goal.

In the time remaining, I would like to focus attention on objective one under the risk management goal, specifically the two action items. First, we strongly support the need to harmonize standards and regulations between state and federal governments and among federal programs. If the issue concerns food safety standards and regulations based on sound science, there is no reason for having different national, state, and local standards and regulations. It makes no sense from a food safety standpoint.

As for the second action item under this objective, that is the need to build the infrastructure to support a seamless federal, state, local food safety system, we strongly recommend you elevate this action item to an objective. We also urge attention be given to the need for strong oversight and internal auditing to ensure accountability of the process.

As for objective two under this goal, we support what you are saying, but caution you to be very careful in your wording. The use of the phrase, and I quote, "preventive techniques and controls using risk based approaches," has the potential to be misinterpreted to support the use of a precautionary principle or approach as defined by our colleagues across the ocean. NFPA knows this is not what is meant, but we urge you to use such terms as, "science based risk assessments," more freely in the phrasing of this objective.

One objective contained in the strategic plan that I would like to address specifically is expansion and enhancement of inspections and performance standards. We are concerned that the strategic plan's focus here is on expanding government's enforcement authority rather than targeting existing authority and resources to ensure that they are most effectively applied.

NFPA feels that certain changes would result in more efficient inspection regulation of the food industry. Much can be accomplished by cooperative efforts among agencies, both at the federal and state levels. Such cooperative efforts should target a risk based food regulatory inspection system which focuses all available resources, regardless of whether it is for meat, poultry, seafood, eggs, dairy, or vegetables onto areas where attention is warranted. Thus we support the plan's objective to prioritize inspections by risks to public health and allocating resources accordingly. We also support the objective for consistent training and consistent enforcement.

On the risk communication goal, while enhanced risk assessment and risk management certainly must be key components of any successful food safety strategic plan, it is the area of risk communication that may pay the greatest dividends in protecting consumers. Therefore, NFPA strongly supports the strategic plan's stated goal that the U.S. food safety system openly and effectively provide information on food safety risks and education on how to control these risks.

NFPA has long urged expanded efforts by FDA, USDA, EPA, and CDC to educate the public on food safety. Education efforts should be aimed where they will have the most impact, for example, in the schools and in local newspapers, and industry should be a part and must be a partner in this educational activity. Extending education to the general public must involve partnerships among industry, government, and the media, and others in the public and private sectors.

Moreover, food safety experts in the government should actively promote safe food practices and processes. NFPA urges you not to lose the opportunity of using the dietary guidelines for Americans as a vehicle for educating the public on safe food handling practices. While we strongly support public education efforts by government, we are concerned that the plan's stated objective of providing "rapid access" to information about food safety surveillance safety hazards, outbreak actions, and enforcement may be misplaced.

While NFPA supports the use of all tools available to recognize and find sources for food borne outbreaks, it is imperative that rules be established that will maintain security of preliminary information and assure that information is properly reviewed before public release. Although it is tempting to opt to err on the side of safety and inform the public of all of the possible risk factors, our experience is that this is overly conservative and can negatively influence the effective handling and resolution of a food borne illness outbreak.

Subsequent messages regarding food borne outbreaks have diluted effectiveness, especially when the message changes. Thus the public and the regulatory agencies are better served by targeted and accurate messages about food safety problems. It is our strong belief consumers should be notified of food recalls only when the products in question pose a threat to consumers and consumers need to take action. Releasing information to media and consumers on each and every recall would overload consumers with nonessential information and very critical alerts on which consumer attention should be focused.

A final area I wish to address is consideration of organizational changes to the way that our nation's food safety system is governed. The current regulatory system in the U.S. has provided the framework for what is generally regarded as one of the safest food supplies in the world. While enhancements to the effectiveness and improvements to the coordination of this system should be sought, we must not lose sight of the fact that the current system has been highly effective in protecting consumers.

To become more effective, regulatory agencies must adopt a scientifically sound, risk based approach to developing and implementing regulatory policies, as outlined in the strategic plan. Cooperation within the existing system can produce the desired results.

In conclusion, NFPA supports a strong government program to provide every reasonable assurance of the continued safety of America's food supply. By working cooperatively, consumers, industry, and government can continue to achieve the highest levels of food safety. We thank you for this opportunity, and we will carefully study the plan and provide detailed comments at a later date, including suggestions on how to evaluate progress and measure success.

We look forward to working with the task force on ways to further improve and enhance the effectiveness of our nation's food safety system, an overarching goal that we all support. Thank you.

DR. WOTEKI: Well, thank all of you. Let me ask, first of all, do any of you, Dr. Applebaum, Ms. Donley, and Dr. Sienko, have thoughts or comments about what you have just heard from other members of the panel?

MS. DONLEY: I think it is rather interesting that we all bring our own personal experiences and personal perceptions here on this. And I just would like to make a comment, I guess from the public consumer perspective. I just -- I also would like to see, I think, that there is an opportunity here with this plan to do a risk assessment, if you would, on the whole farm -- look at the whole farm to fork continuum itself and allocate resources accordingly, and where you have an opportunity to make the most impact and the most beneficial impact to the public health and safety.

And I guess what brings me to that point were some of the comments about consumer education, public education, and what some parties view as what the public needs to know and what the public doesn't need to know. And so I really think there that if, with this vision statement being that all parties know and understand their responsibilities, they have to be given food -- because everyone understands and fulfills their responsibilities, we have to be given the complete picture.

So you can't just give a little bit here and take a little bit there. It has to be a full disclosure by all parties.

DR. WOTEKI: Rhona.

DR. APPLEBAUM: I'm just very pleased to see -- and perhaps I'm just being a bit optimistic, but I don't think I am -- that we are not that different in terms of our focus. Obviously, I think we all do share the overarching goal. We want to enhance the safety of our food supply. We want to make it, to the extent that we can, as safe as possible. So I'm encouraged by the fact that I did not hear any major differences in terms of where we are all heading and wanting to work cooperatively to that end objective from the representatives from the public and -- the public sector as well as the consumer sector. So I am encouraged by what I have heard this morning.

DR. WOTEKI: Okay. Have any thoughts, Dr. Sienko?

DR. SIENKO: Oh, I would probably just echo that, that final comment. And I think we have a plan here. We have something to work with. And I heard a lot of shared visions and statements of purpose. And I think to go forward, we need to build on those areas where we do have a common ground, and not to destroy this, in a manner, based on those areas where we have differences.

We need to resolve our differences, and we need to discuss those. No question about that. But I think if in our discussions today, we can frame this in terms of the many areas where we want to move forward and advance the food safety system, that is in all of our benefits. And I heard a lot of that in the comments that were made.

DR. WOTEKI: Let me then open up to -- let's first start with the folks that are seated at the table. We have got about ten minutes before our first scheduled break. And are there any initial things from the panel's points that you would like to comment on? Let's just go counterclockwise around the table. Dan Sowards.

MR. SOWARDS: Thank you. I represent AFDO, the Association of Food and Drug Officials and Texas Department of Health. AFDO will be filing some formal comments. But to echo one of the points that Dean made, we would like -- the states and locals would really like to be able to have a document, a finished document, that we could take back if we needed to to our state legislatures and say, see, this document looks at a national framework for food safety in the United States, and it points out the place that state and locals have in the overall picture of food safety in the country, and that it isn't a statement that says that the four, six, eight, ten federal agencies that have a role in food safety are the only players in food safety.

We echo the position that there should be federal oversight of state programs, strong oversight. We echo the idea that we have an overarching plan for, let's say, lab certification, not just food inspection programs, so that if this were adequately reflected in the final document, we feel that it would be a more appropriate way of saying to consumers, academia, industry, and to the states and locals, as well as the federal agencies, that this is a plan that we can use the enormous resources throughout the country in food safety to increase and reduce -- increase oversight, reduce food borne illness in this country.

Dean mentioned the -- he used the term federal system and national system. Twice, I believe, in the document it refers to national food safety system. In early December, when we had our meeting, the task force members indicated that the we in the national food safety system includes state and local. I think that that needs to be strengthened in the document to show that the resources and the role that state and locals play out there is a very vital role, particularly in the enormous amount of resources that we have out there. And I'll stop.

DR. WOTEKI: Any other people who want to comment who are sitting here? Okay.

MS. DeWAAL: Caroline Smith DeWaal, Center for Science in the Public Interest. I'm less concerned about what is in the plan than what is not in the plan. It doesn't answer some really critical questions which were raised by the National Academy of Sciences in their report ensuring safe food, which this panel was specifically asked to answer. It doesn't tell us who is in charge of food safety. It doesn't tell us what is the best approach for managing existing and emerging hazards in the food supply. We have two different agencies that utilize two entirely different approaches.

It doesn't tell us who is accountable if things aren't done. It doesn't give us timelines for accomplishing these objectives. It doesn't unify the agency's approaches. It doesn't give us consistency in addressing hazards between different hazardous food products that are regulated by different agencies.

There is no single regulatory approach in this document that I can see. So it doesn't answer these critical questions. I guess I'm a little concerned, and there is a lot of really good stuff in the document. And I'll try to point that out as I comment later in the day. But I'm a little concerned there is no there there, which means that these strategic plans end up in drawers all over town, and they are not acted on, they are not funded.

And without the real meat of the answer to the questions posed by the National Academy of Sciences, CSPI, and other groups on who is really in charge here, I am very concerned that this strategic plan doesn't do what it was meant to do.

DR. WOTEKI: Thank you. Does anyone on this side of the table have a comment you would like to make at this point? How about seated on this side of the room, anyone? Okay. Please go to the microphone and identify yourself.

MR. MANN: My name is Jim Mann. I am part of the industry group here. I'm in the process of writing a strategic plan for a new company. It is Health Minder. We are dedicated to safe handwashing solutions. I'm here, and I am enjoying very much what I have heard already because it helps me set some long term engineering solutions to work. We do have to find uniformity, and I like the idea of stressing science.

As I face writing my strategic plan, I am reminded of how tempting it is to want numbers on everything. Certainly, my boss wants that. But you have to look at a strategic plan as a guideline. There is another plan that is an operational plan. So I would encourage the group to think about that. And perhaps we have too many words in the vision. Maybe it should stop after the first sentence, and find the areas where the common ground is so that we can move forward on that. Thank you.

DR. WOTEKI: Good. Anyone else behind me who wants to speak? Okay. How about on this side of the room, and at the back? Okay. Everybody wants a cup of -- okay. There is one right here.

MR. KRUEGER: Bill Krueger, with the Minnesota Department of Agriculture. And also, I am with the laboratory operations and coordination work with NFSS as well. I am the chairperson. Throughout the document, it uses the words share and coordinate information, I think for better risk assessment and so forth, and trend analysis. But we don't emphasize the mechanism to do that. And I realize this is a strategic plan, and it has go to be general in a lot of its terms.

But under the science and risk assessment goal, there is an action item that says to encourage data sharing among all relevant sources of food safety information. I don't think that encouraging sharing is strong enough. I think that we have to -- as Dean pointed out, real time is a critical word here. And I think that we have to develop standards and systems that will facilitate rapid real time sharing of information.

In the absence of that, the word sharing in that has interpretations to a lot of different people. And because the systems are in place, we have success stories like Pulsenet, but I think we need many more of those in the nation in order to have that sharing take place. So standards and systems need to be in this document somewhere.

DR. WOTEKI: Good. Thank you. We're right on time at this point for a break. Before we break, though, I want to indicate that we have asked that the temperature be reduced in this room.

(Laughter)

DR. WOTEKI: If any of you are uncomfortable, please do not feel constrained if you want to remove your jacket. You will not offend anyone. But it is really overly warm for those of us who dressed for the 20 degree temperature outside. Well anyway, we are trying to get the hotel to, if they can, reduce the temperature in this room.

And also, before we break, I wanted to introduce to you the other person who is sitting here who I did not introduce this morning, and that is Dr. Cliff Gabriel, who is seated on my left next to Susan Wayland. Dr. Gabriel is here representing the Office of Science and Technology Policy. And as many of you who are familiar with the President's Council on Food Safety know, that Dr. Neal Lane, the President's science advisor and the head of OSTP, is the cochair of the council along with Secretary Shalala and Secretary Glickman. So, Cliff, we are glad that you are here.

Anyway, we'll take a 15 minute break at this point and reconvene at 10 o'clock.

(Recess)

DR. WOTEKI: We'd like to get started with the next session, so please take your seats. Before we start, let me remind you that if you do want to be an active participant in the discussion, anticipate that you are going to have a lot to say, move up to this table. And don't feel constrained. Do find a seat at the table. Also, I'd like to remind you, before you comment, to please give your name and identify the organization that you are representing.

Susan Wayland is going to be chairing this next discussion session. So, Susan.

MS. WAYLAND: Okay. This next discussion will be a full plenary discussion about the overall framework. And I think that the panelists really gave us an excellent jump start on this session, as well as some of the comments that we received in response to the panel's comments. So I think that we already have some good ideas. And this is an opportunity for the next hour or so, or however long or however little we want to delve into this topic before we move on to sound science and risk assessment.

So this discussion will be about the overall framework. And there are three questions that you will see on your agenda. First, is the overall goal and the overall framework of the plan well focused and comprehensive? And we have heard some comments on that, and here is our opportunity to get into even more depth on that question.

The second question is what modifications would you suggest. And feel free to be very specific about the kinds of modifications that you would like to see in the draft that you have in front of you. And third, what issue or concern would your modification address?

So with those three questions in mind, we would like to open up the floor. And I think we are going to do this the same way that Dr. Woteki did the first session, which is we are going to go around the table, and then we'll go around the room, and see if they have something they would like to say. And because variety is the spice of life, we are going to go clockwise this time, and we are going to start on this side of the table. And let me just ask if any of you would like to offer some thoughts on these three questions on the overall framework.

Okay. If not, about the back of the table or the front of the table? Any other comments? Okay. How about this side of the table? Yes, sir.

MR. STEINHOFF: I'm Steve Steinhoff with the Wisconsin Department of Agriculture Consumer Protection, a division of Food Safety. I'm also a member of the AFDO board and work on a national integrated food safety system project.

I just had a general comment about the whole document. There is the sixth point in there. It does have to do with coordination. That's fine. And I think there is a lot of good stuff in the document, science based, risk focused, very hard to argue with. The other piece that is always there, though, is limited resources. I doubt that we have all the resources we need. So prioritization of things is very, very important.

The piece that I think is missing, or it is stated there, is it has to do with agencies working with state and local governments and tribal governments. But the issue of correlation and coordination and integration in a more generic sense, you know, within the agencies, even at a federal level, if you narrow to that, just within the federal system, between agencies and within agencies, if you want to get your bang for the buck, you know, to use your limited resources wisely, to use a term I use with my children, you have to be aware of the world around you, you know, you have to know what others are doing so that you can connect with them and do things effectively so you are not wasting a lot of effort and duplicating it, and so that you use what limited resources you have wisely.

I just think it needs to be made -- that point needs to be made more often at the beginning and throughout, and as you talk about specific action items.

MS. WAYLAND: Thank you. Yes, sir.

MR. SOWARDS: Yeah. Dan Sowards, Association of Food and Drug Officials and Texas Department of Health. To strengthen some of the statements I made earlier regarding the role of state and local, I think it would be very advantageous to all of us, considering the enormous resources that are out there at the state and local, understanding that you need adequate federal oversight, you need as uniform regulations as possible, I think the statement in one of the objectives that you have in the document regarding the examination of the laws and regulations and rules, standards, that currently exist at the state level, there are a number of gaps that we see in the federal system that by examining state and local regulations, state in particular in this instance, and seeing where certain state regulations could strengthen the national system, fill gaps in the national system -- that is an excellent point that you made there, and I think it needs to be done -- and to also mention the partnerships that could be developed with state and local.

Our resources are such that in order to strengthen the federal system, the national system, I think the federal agencies need to look at what the state and locals not only are doing, but what they are capable of doing, and saying, okay, if we can integrate those resources, both human resources and dollar resources, into this national system, then where can we most effectively our federal resources in this system because there are things out there that the states and locals are doing.

For example, I think about in 90 percent of the inspections of non-amenable foods in our system are currently conducted by state programs, state and local, if you consider retail. That being the case, then there are obvious advantages to using those resources even more, and at the same time being able to focus the federal resources into more specific areas where risk is greatest into research and so forth.

So I think that if the document can be adjusted to include these considerations, it will be a stronger document.

MS. WAYLAND: Thank you very much. Any other comments? Yes, sir.

MR. HIGGINS: Yes. My name is Tom Higgins. I'm manager of regulatory affairs for Viskase Corporation. Viskase appreciates and thanks you for the opportunity to comment at this public meeting. Viskase is proud to participate in the development of this food safety strategic plan.

Viskase is a packaging company. And among other products, we make packaging for holding food during irradiation. And that is what I want to talk to you about today. I want to talk really about a specific action step that would improve the plan, and that action step would deal with issues of food safety that are simple. They are straightforward, but they require government review.

I'm specifically talking, in the case of our packaging, letters of no objection, which are granted on our request for the review of packaging, and particularly for the review of packaging that is for holding food during irradiation. The FDA has stopped writing letters of no objection, and I would like this strategic plan to address that and to restore priority to letters of no objection, particularly when they are needed for food safety.

The reason I -- the reason letters of no objection are useful is that packaging and the review of this packaging is a pretty simple and straightforward process. This packaging is composed of components that are already cleared for irradiation. But it is still -- our formulas still require government review.

To give you a little more specifics, we have 13 formulations in now with the FDA on requests for a letter of no objection, and we are having difficulty getting output from this process, and that output being the letter of no objection. In March of last year, we were told that a formula that was submitted four months earlier met all requirements, that we had verbal approval on that formula, and a letter was promised, the letter of no objection, a clearance letter.

We have not received the letter. And at the end of last year, in follow-up, we found that these letters are no longer written. To make matters worse for this case, the reviewer that we have been working with has been promoted. That is not the bad part. The bad part is we are left holding the verbal approval, and the reviewer no longer has anything to do with packaging approval.

We are very troubled because of this loss of continuity, and it is unacceptable to stop issuing letters of no objection. So I would like this plan to address that and to restore priority to issuing -- writing letters of no objection.

Our dialogue went this way, and our follow-ups, this case. What is the status of our request for letters of no objection? Letters of no objection are no longer written. Are we doing something wrong? No. We want you to submit your packaging films for review. Well, why don't we get the promised letter? Well, FDA is working on a priority for food safety, and we are concentrating on petitions related to food safety and other petitions. Letters of no objection are ordinary correspondence, and we don't write ordinary correspondence any more. But these letters are related to food safety. Yeah, but they are also ordinary correspondence, and we don't write ordinary correspondence any more.

Well, should we resubmit, perhaps as a petition? Well, you can do that, but it is not going to give you what you want. We'll evaluate your request, and we'll convert it to a request for a letter of no objection. That will result in a letter of no objection, but letters of no objection are ordinary correspondence, and we no longer write ordinary correspondence. But these letters of no objection are related to food safety. Yeah, but they are ordinary correspondence, and we don't do that any more.

Well, how about premarket notification? This is the new quick way to get FDA approvals. Well, you could do that. It wouldn't give you what you want. We would evaluate your request, then we would convert it to a no objection letter request. That will result in a letter of no objection, but letters of no objection are ordinary correspondence, and we no longer write ordinary correspondence.

Well, none of this really makes sense. And so we are asking that priority to writing letters of no objection be restored. Thank you.

MS. DEASY: -- action additional action item -- to address this?

MR. HIGGINS: Yes, I would. And I would like to see an action step to address simple, straightforward matters of regulatory concern that require government review. When you have a process like this that is government review, you have got an input, and that is our request.

MS. DEASY: You were very clear. I appreciate that. I just wanted to clarify.

MR. HIGGINS: Okay. And we would like to see the output, so you truly have a process.

MR. LEVITT: Could I just say, since that area isn't my program area, I thank you for the suggestion for the plan. We will not wait for the plan to address that. I take the point very clearly.

MR. HIGGINS: Thank you, Mr. Levitt.

MS. WAYLAND: Okay. Anybody else on this side of the table? Oh, excuse me.

MR. COLETTE: With apologies. I'm sorry that I missed my part of the cycle.

MS. WAYLAND: That's okay.

MR. COLETTE: I'm Robert Colette, with the National Fisheries Institute. And I would like to thank the government agencies for the opportunity here to have the public comments today. NFI does plan to provide more detailed written comments before the deadline.

In regard to the particular section that we are on right now, which deals with the overall framework, I want to make a quick comment about the first question here regarding the overarching goal and the overall framework of the plan being well focused and comprehensive. We actually liked the vision statement and the overarching goal quite well. I would like to point out, however, that the vision statement uses the term farm to table preventative strategies. And I know that that is sort of the coined buzzword that is being used.

But it doesn't recognize the fact that some foods do come from other than the farm, such as the oceans. So it might be something worth considering.

MS. WAYLAND: Thank you. Okay. Any other comments from the table? Yes, Ms. DeWaal.

MS. DeWAAL: Thank you. Caroline Smith DeWaal, with the Center for Science in the Public Interest. I think one thing that is missing from this first really two paragraphs of the document is an emphasis on prevention. From the standpoint of consumers, we would really like to see food safety hazards prevented at either the far or the processing plant rather than relying on education to inform consumers that hazards exist.

So I just note that the concept -- you mentioned farm to table preventive strategies. But it doesn't follow into -- or it doesn't follow enough into the actual overarching goal. So I think I would like to see that remedied, and I don't have a specific language on that.

I do think that the United States -- that under your section on risk management, you said the United States system for managing food safety is effective from farm to table. I think we need more than one that is effective, although one that is effective would certainly be an improvement. But I think we also need one that is coherent and one that is applied across the board on the basis of risk so that we don't have products that represent a similar hazard for consumers that are regulated under entirely different regulatory programs.

So I would like to suggest that you add to that. Maybe you could also prevention here. But the U.S. system for managing food safety focuses on prevention and is coherent, effective, and applied across the board on the basis of risk from farm to table, or from farms and sea to table. So I would just like to propose that because I think you are missing some rather critical element.

You know, the gentleman over here had a great story about bureaucratic issues. It gets worse when you actually have to deal with agencies who have multiple responsibilities for approving food safety technologies, or have duplicative responsibilities for inspecting food plants. I mean, the pizza plant is the best example there. I am still not seeing in this document the answers to the criticisms of the current system which we have laid out extensively in comments to this council.

So there are still -- we are still missing the boat on a lot of these bureaucratic inconsistencies. Thank you.

MS. WAYLAND: Yes, ma'am.

MS. LAUTNER: I'm Beth Lautner with the National Pork Producers Council. And I would say -- one comment that I would make on the visions statement, I would agree with the visions statement, but -- and perhaps to address somewhat of what Caroline may have said, we would like to see the word education moved up after research because that is one of the focuses of when you conduct research, to put that into a technology transfer education process. And hopefully, if you do that successfully, you have to do less of the inspection enforcement part. So education, I think, is an important part.

The other comment I would like to make briefly is that I am cautiously optimistic about the strategic plan. I think -- and based on the track record already from the food safety initiative, I am very fortunate to not live in the beltway, and get an opportunity to go and see what is really happening, what is actually filtering down to the group I represent, which is producers. And I can say that we have seen some tangible benefits from the coordinated efforts that have taken place, and we see that this strategic plan provides future opportunities to continue that coordination.

And just a couple that have gotten to the producer level that we are using are the enhanced surveillance through the Foodnet, Pulsenet. That information is helpful to the producer communities to try to understand where they fit and what they need to be addressing.

We are seeing real tangible evidence of coordination on food safety research from the research -- USDA research agencies. We are seeing coordination of researchers. We are seeing more tangible information being transferred to producers there. We are seeing more cooperation from state departments of Ag, through FSIS' animal production food safety program. We are seeing -- being able to help us extend the reach of our quality assurance programs to reach more producers through those types of things.

The Partnership for Food Safety Education has been very successful. It has been a way for us as a producer group which has limited resources to be able to leverage with others, with other industry groups, consumers and government, consumer education. And we visibly have been participating in that.

I think those are all reasons, I think, for our group to be cautiously optimistic that continuing on this road with a strategic plan the components are in there. We may all have comments of things we would like to see added or worded differently. But I think for tangible things that we are seeing out, that are things that we can use to impact food safety, I think there has been successes already, and hope to build on those.

MS. WAYLAND: Great. Thank you. Yes, ma'am.

MS. DUNHAM: Yes. I'm Bernadette Dunham, with the American Veterinary Medical Association.

MS. WAYLAND: Could you go ahead and repeat your name again because the microphone was being moved at the very moment you were saying who you were.

MS. DUNHAM: Bernadette Dunham, with the American Veterinary Medical Association. And again, we thank you for having the opportunity to say a few things while you have your whole day conference here. Generally, we do in fact support and are very pleased to see the science risk assessment based approached that you now have outlined.

At this time, one comment just to make, and that would be to see how interesting this particular proposal is going to compliment or follow the established objectives that are going to be released with the Healthy People 2010 initiative, which I think is going to come out January 25th and 28th. And I would hope that overall, as this goes forth, both of those can actually compliment each other. I think it is going to be very important that they do.

So at the moment, that is the only thing right now. Thank you.

MS. WAYLAND: Okay, great. Thank you. Any other comments from folks at the table? Yes, Ms. Donley.

MS. DONLEY: Nancy Donley, from STOP. When we submit our public comments, frankly, I am going to redraft your vision statement and make some changes. But one thing I just -- I think that when we talk education, and throughout the day, and that maybe start thinking a little bit about, is that education without behavior modification is nothing. And we have got to build in some sort of measurements of, say, what types of behaviors are actually changing.

And also, I think what we need to be looking at is remembering that there is just not one group here that needs education. Education is something that needs to be done. It is not just a consumer issue. It is an issue that needs to be done all along the line. I hear it being really focused primarily as being just something that is consumer oriented. And I think we are missing tremendous opportunities there. But we have got to be able to somehow assess how effective educational campaigns are.

And then -- I guess that is it for now. Thank you.

MS. WAYLAND: Okay. Great.

MR. SOWARDS: Yeah. This is Dan Sowards, with AFDO. I wanted to strengthen a couple of points that Caroline made, and that is the emphasis on prevention and across-the-board application of food safety measures. We have seen FSIS adopt HACCP for meat and poultry. We have seen FDA adopt HACCP for seafood then for juice, as we found problems with juice. We foresee that that may be the situation with sprouts because of the situation with sprouts.

What we would like to see is the concept of universal HACCP applied across the board to food. Now that doesn't mean that everyone should -- that laws and regulations should mandate HACCP for everyone. What it does mean is that the initial step for HACCP, that is the risk assessment, should be mandated for all foods. Then we can determine where HACCP is needed and where it's not. I think that's a concept whose time has come.

MS. WAYLAND: Thank you. The gentlemen in the back that are -- the two gentlemen that are standing, do you want to come to the microphone?

MR. PARK: Thank you. I'm Doug Park. I'm with epidemiology and food safety at the Michigan Department of Agriculture. And I also chair a work group with the national food safety system. And I would like to make three comments regarding the overall framework on -- as represented on page 2 of the document. And I would like to echo what Dr. Sienko said earlier, and that is that the overarching goal perhaps could be embellished a little bit to include three additional items.

First of all, surveillance is not referenced, and yet you will find surveillance enumerated a couple of times within the objectives. Also, secondly, with regard to state and local agencies, we are inundated daily with complaint systems. There is a feedback loop, and the complaint systems are -- they are a great source of information and should be included here, we believe.

And then thirdly, the large amount of activity as epidemiologists that we have results in activities in outback and trace back. And that is a third item that perhaps should be looked at and included in the overarching goal. It is certainly a great impact on state and local agencies.

Secondly, in the objective two in a very important document, the initiative, and that is with regard to data collection, all of our agencies across the nation are collecting a lot of material. And perhaps that is not the greatest need. But it is sharing the information that results from that data collection. And perhaps we should look at embellishing that a little bit to say data collection and information sharing.

And then, finally, as Dr. Sam Page has eloquently pointed out many times, with regard to bioterrorism events, the statement that adverse human health outcomes should be related is certainly important. But with regard to bioterrorism, perhaps there is a need to include this as a reference, either on this line or another line within the goal. Thank you.

MS. WAYLAND: Thank you.

MR. HOLMES: My name is Scott Holmes. I am chief of the environmental health division with the local health department in Lincoln, Nebraska. I am here today as an active member of the National Association of County and City Health Officials, which represent about 3,000 local health departments.

When you eat lunch today, FDA, USDA, EPA, they did not inspect the restaurant that served your food. Local health departments did. Every place in the nation, just about, that is the case. And so when -- I realize that there are huge and critical issues, especially on the production side -- in fact, I think there have been huge steps forward in the last few years to address those, yet on the inspection side, there are still some major issues to be addressed there.

But my comments are really related to the vision statement. And I think Doug touched on the overarching goal in the vision statement. The word surveillance is used. In the overarching goal, surveillance is not used. Just a little nuance there, but I think there has been a lot of effort put into this plan, and those sort of things are going to happen.

But perhaps the question that comes to mind, is this a federal food safety plan or is this a national food safety plan -- I think that comment was made before. And I don't know that we have the answer to that yet. I do realize that the federal strategic initiative has to focus on federal government. But a seamless system, as identified, has to include state and local government. And I would suggest the vision statement could be broadened to add a statement that it views state and local food agencies as full partners in the seamless system. That simple statement then makes the rest of the document work for state locals for the most part.

We can pick and nitpick. But you don't mention it there, and then it's touched on in various areas throughout the document. I don't see why it isn't just said up front in the vision statement. And that's all my comments.

MS. WAYLAND: Thank you very much.

MR. OSAKI: My name is Carl Osaki. I just retired last year as the chief of environmental health with the Seattle King County Department of Public Health. And I have had a few episodes that I have had a chance to work in real time, Jack-in-the-Box and Autwala (phonetic) outbreak regarding e. coli. I am also a clinical social professor at the University of Washington in the School of Public Health and Community Medicine, where we teach food safety to students.

By my reason for being here really is as a member of the Washington State Board of Health, where we make policy regarding health for the state of Washington citizens, including food safety. And as a matter of fact, just within the last six months, we have passed two food safety regulations in the state of Washington as a state board of health, not because the federal government told us to do so, but we felt it was the right thing to do. One is that we are requiring 30 minutes of interactive training and education for all food workers in our state. And another had to do with ensuring that any restaurant that serves unpasteurized juice notifies all of its consumers that it is unpasteurized.

I'm going to work backwards here and say that on the overarching goal, I would, one, make a suggestion, and that is that you talk about coordinated regulation, inspection, et cetera. I would recommend that we say something about coordinated policy development as well. And the reason I say that is, again, in the state of Washington, we have a board of health. And I think about half of the states in the nation have boards of health that define food policy, develop regulations. The rest of them default, I think, to the state legislature for food safety regulations.

I am not accountable to any organization at the federal level as a Washington state board of health member to set food state policy. However, it would be nice if in fact we had some kind of continuity in terms of policy development from the local to the state to the federal government. It has to have some kind of a flow of accountability or some incentives so an objective, for example, might be something that creates an incentive for state and local health departments for developing policy that is consistent, for example, maybe a certification program for state and local health departments upon -- using agreed upon performance standards, and actually tie it in with some kind of monies that are available from the federal government to do so.

So I would suggest that policy development, along with incentives, be a part of the strategic plan to make it work. Thank you.

MS. WAYLAND: Thank you very much.

MS. BILLAUER: Thank you. My name is Barbara Billauer. I am with the Association of Environmental Health Academic programs, and I want to retake off what Ms. Donley said. Education is not just important for the consumer; it is important for the people who are involved in food safety. We are talking about food safety today, but what about food safety tomorrow? Who is training the future food safety people?

And that includes not just the inspectors, but the people in industry who should be doing internal safeguards, and the people in service institutions who should be making sure that there is internal compliance with internal policy that might be generated as a result of a meeting like this, but is useless if it is not part of the corporate culture. And so where most corporations now have OSHA or EPA assigned health and safety people, I'd like to see in the future that we have that same commitment in food safety. But then the question is who is training them and what is the training.

At this moment, most states will hire inspectors -- or may hire inspectors; they are not required to -- and food safety or other environmental health safety professionals who are not required to attend an accredited college with a program in environmental health. That means that I can make sure or feel comfortable that my manicurist has some degree of certification, but the person in my state may not have that same level of oversight.

And so I would like to call up this council to do three things: one, to support the National Accreditation Council on Environmental Health's role as a federally approved accrediting agency so we can make sure that those programs that exist in the country do have an approved standard in environmental health programs and curriculums. And the second thing is I would like to see a commitment to the future of students who will end up in the field of environmental health, and that is in the form of scholarships, internships, working for people like yourselves so that these young students can see the way we hope things should be done, as well as -- and this is a sad fact, that the number of students in environmental health programs has been declining over the past five years.

That means that the field is not perceived as being glamorous or important, and that can be done through public relations and through a commitment by the federal government to impress upon the country that we need to appropriately train people that can carry out this mandate. Thank you.

MS. WAYLAND: Now were there any other comments? Let me just -- yes.

MR. MANN: Jim Mann, Health Minder. I just wanted to -- I was looking for an appropriate place to put the potential addition here that industry is the primary person responsible for food safety. From a strategic point of view, I find that helpful to be acknowledged somewhere here, that we are trying to help them. Perhaps by the end of the day, I'll come up with some wording. But I just wanted to make that point. Thank you.

MS. WAYLAND: Thank you. How about from behind here? Yes, sir.

MR. GARCIA: I am Dr. Genaro Garcia. I represent the Pan American Organization. Briefly, I want to thank you, you all, USDA, for inviting us to this important forum. I just came two weeks ago to Washington. I was -- Barbados, and I came just about two weeks ago with my family, just am glad to be here.

I have probably three specific comments, information to the mission statement and the overarching goal. I endorse the motion on -- board of education to -- the orientation after -- right after research. I would say -- I would suggest to put it after, immediately after, surveillance because -- the reason being that surveillance and research are basically all the same thing. Research studies are a part of surveillance. Surveillance and research will provide the information to elaborate the educational tool and different levels and targets to the different people. That is one suggestion.

The second one is in the overarching goal is reducing the prevalence of food borne hazards and will include after food borne the word -- two words, food borne -- before, I'm sorry -- prevalence of old and new food borne hazard, the reason being that there is a characterization already being done at the -- characterization of the old food borne hazard and the new one. And that characterization is already being done; information is available. Therefore, I believe that is important.

I also endorse the inclusion of the epidemiological surveillance in the overarching goal. The reason has been explained by various of the speakers. But I want to emphasize that the epidemiological characterization is very important given the scarcity of resource and the need to prioritize in the explanation.

I believe that the information was at the National level and at the local level, and I would give more importance to the local level analysis of the information, the epidemiological information available in order to do the epidemiological characterization of risk according to the epidemiological trends, what are the food borne more likely implicated associated with food borne outbreak and -- what are the critical control point violation.

All this information may be available, and that has to be analyzed in order to prepare a profile, epidemiological profile, at the local level in order to prioritize the industrial strategic plan and in the uses of resources, and therefore getting a more cost effective and cost benefit in the smaller resources.

In relation to education, again, going through what -- I know we are going to touch on the risk communication. But I didn't see the word there of universities, college, or that has been mentioned. And I believe there is a really having the opportunity to be in Davis in California in the early 80s, I know that all the extension services at the university have no material education. And I believe they need to particularly compile all this information and -- probably standardize and use the information that is already available.

Thank you very much.

MS. WAYLAND: Thank you. Let me see if there is anyone else from behind here before I turn to you.

MS. MURANO: Thank you. Elsa Murano. I am associate professor of food and microbiology at Texas A&M University and director for the Center of Food Safety at Texas A&M University.

I wanted to start off by saying that I agree wholeheartedly with Nancy Donley about the vision statement. I think it definitely needs a lot of rewrite. And I agree with what you said as far as what implications it might have on the minds of consumers or other groups when they read it and maybe get the wrong impression. But my comment has to do with I love the fact that this strategy or strategic plan is science based.

It is a term that I think we should all appreciate. And for that reason, I would like to really emphasize that we include the word science as much as possible throughout the document. It is here or there, but perhaps not in there as much as it should be. On the first objective, for instance, or the first goal, I would love to see the scientific community's input be showcased as a place where information would be gathered in terms of research.

That has a lot to do with the way that we have viewed food safety over the last few years. We tend to be very reactive, even in terms of funding. Listeria, e.coli 0157:H7 are the bugs of the moment, so all of the funding goes to those. And we talk about looking at emerging threats, but do we really look at emerging threats, or are we always, because of what is in the news, always looking to work on those threats that are right now and important.

I would suggest to you that by having the scientific community be an integral part of the decision making process, is that we will include such things as looking at the microbial ecology and factors, environmental and otherwise, that may promote the emergence of new food safety threats. And that is something that I really didn't see in here specified as well as it should be.

It talks a lot about surveillance, and surveillance -- I will disagree with my friend from PAHO. Surveillance and research are not the same thing. Certainly, surveillance is something, as we know, that provides the data on perhaps where we should be focusing our resources in a way. But research, especially basic research, is really where we get our focus for what may be coming down the pike. Otherwise, we will continue to be reactive, and we cannot afford to be reactive any more. Thank you.

MS. WAYLAND: Thank you. Yes, sir.

MR. DOOLEY: I'm Lou Dooley, with the Southwest Washington Health District in the great state of Washington, the other Washington, and also representing the National Association of City and County Health Officials. I want to make a couple of comments about the overall framework of the plan and just -- and think that we need to strengthen our system to get to what Scott shared with us a little bit as where the rubber meets the road. We need to be able to make the system stronger out there where we are doing the inspections and are doing the leg work that is necessary.

I agree with the comments of the former -- of the person just before me. However, we need to be able to communicate those issues to the people who are affected and those that are the consumers of the products that we inspect or the food service establishments that we interact with. And we need to be able to communicate to them. And if we start trying to talk about the difference between research and surveillance, we are never going to be able to meet those needs because we have got to be able to talk to them at a level that they understand. And we are just poor folks down there at the local level, and we need to understand what the regulations are in black and white and not be able to get lost in all of the rhetoric, or not -- I don't mean that as rhetoric, but get lost in all of the big words of education.

We have a great system in the state of Washington, but we approach public health as a four legged stool. It is academia, particularly the University of Washington and the state systems, the state board of health, the state department of health, and local all working together. And we do that because we can communicate together.

Now our problems are very large. And what we are trying to do address with this system is very, very large. The states and locals can't get their arms around the issues that we see or that we all agree are some of the problems. Imports, exports, just the coordination of issues at the federal level is more than the federal level can deal with. When we get down to it, we need to get down to where -- to the implementations of the rules and the standards.

About the vision and the goal, I feel strongly that we do need to set a vision that is out there beyond where we are at right now. We have gotten into problems in this country because we have been able -- because we have always boxed things in. And we need to look beyond it. And that is what a vision statement is. We are looking out there, is this somewhere we want to be.

Now maybe we need to articulate that a little bit differently because I agree, we can't put the public to sleep and say that we have got a great system. But we have to have it out there beyond where we are at right now. It has to be a vision or else call it something else. But if we are going to call it a vision, it has to be out there, something that we are striving to get to.

We have to have the capacity to respond. The local level, the state level, can't reasonably set risk focused science based standards and issues. We have to look to the federal level to do that because that is where the science is. That is where those standards are set, on a national basis. And we can't do that at the local level. We need to look to you to do that. We are going to implement them down where the rubber meets the road.

You can really help us in doing that. The communication is really the success, or really the key to success, of a lot of this. We have had more than our share of issues in the state of Washington. Carl talked about the e. coli and the odwalla issues. We also have had just some issues with e. coli in a swimming lake where we had 34 cases 0157:H7 in a lake. We were able to respond to those very quickly and prevent people from becoming more ill, or more people from becoming ill, because we could communicate.

We had a federal system that has been implemented in the state of Washington that allowed us to communicate with CDC and every other health district that was participating in the pilot project, where we put a health alert network across the country. That communication opened up the ability for us to be effective and prevent illnesses from growing. We responded well, and it was through the coordination of the resources from the federal level to the local level. And we need to clarify who, what, where, and when -- what our rules and expectations are. And we can best do that in a document like this.

We appreciate the opportunity to testify and give some input into this. We need to all work together as partners and work on the successes rather than just relying on the frustrations of what we have done in the past. When we do that, we get beyond the issues and start to look at emerging things. But we also can't lose face -- or lose sight of the fact that we have diseases, communicable diseases, which we thought were controlled in the past but are coming back because we have been off looking for new things and new emerging problems.

But we have problems like polio and tuberculosis, things coming back that we thought were controlled. And we can't lose sight of that either.

MS. WAYLAND: Thank you very much.

MS. STEVENS: Jennifer Stevens, with the American Academy of Pediatrics, Washington office. I just wanted to highlight one sentence from the vision statement: "We are vigilant to new and emerging threats and consider the needs of vulnerable populations." I think it is important to highlight the needs of vulnerable populations right up front, especially infants and children. Obviously, not all consumers are affected equally by food borne pathogens, pesticides, and other threats in the food system.

However, I would -- I think the academy would like to see the impact on vulnerable populations as an issue that is more thoroughly discussed throughout the document, not solely in the vision statement. I think it is important that it is in the vision statement, that it guides -- it is a principle that guides this process. But I think it also needs to be brought up more frequently in some of the action items and some of the objectives.

MS. WAYLAND: Thank you very much. Anybody from this side of the room? I feel like I have neglected you all over here. Any comments anyone would like to come up and make? Am I missing anyone behind me? Yes, sir.

MR. LERMAN: Yes, Dion Lerman. I work at Drexel University in Philadelphia in a program called Food Safety First, where my emphasis is on training food safe -- or food handlers, the people who actually cook the food, as one of our earlier commenters mentioned. And I did notice that they are in fact absent from the list of people that get cited in the document. And I would like to suggest that they deserve some consideration.

My further comments may be a little odd, given that I am speaking -- that I am an educator, and that is what I do. But I do think that the plan does need to focus much more on prevention further down the line. Educating the food handlers and consumers is an important step, but they need to have food that requires less intervention. Let's put it that way.

And I think, for instance, of another product of this group, which is the egg safety plan that one of the task forces put together, which is based largely on an extremely successful plan in Pennsylvania, the PEQAP plan that helped pioneer farm based intervention strategies that has been extremely successful, and would recommend -- commend that to people.

Also, I would like to comment on things that other people have said, our friend from Texas A&M, specifically about science and the science basis, which I think is one of the things that makes the current food safety programs so strong and impressive. But I would also like to sound a word of caution here. When the phrase "sound science" gets used, who says what science is sound? Science is a moving target. And what we know today is different than what we knew yesterday; what we know tomorrow will be even broader. And if we base our ideas on sound science only on what is known, then we are constantly reacting. And as Ms. Murano said, we need to be proactive in our science and constantly looking for the new challenges, the emerging problems, and for creative responses to that.

And finally, that these efforts, as with all of our efforts, need to be transparent and independent. The public is demanding transparency, and it is being codified in Europe right now. I think it is an excellent thing. And if we try to fight it, we are going to find ourselves in a lot of trouble because I do think that ultimately we are all here, all of us, to build that partnership that we keep talking about.

We do have, in fact, common goals. We may have different priorities, but we all have common goals. And we need to remember that.

MS. WAYLAND: Thank you very much. Okay. Are there any other comments? Is there anyone who has an opinion, a comment, reaction to something that someone else has said or your own comment that you haven't been able to make yet on the vision statement? Yes, sir.

MR. GREENBLAT: Good morning. My name is Jessie Greenblat. I worked as a state epidemiologist with New Hampshire Department of Health and Human Services. I'm also here representing the Council of State and Territorial Epidemiologists, a network of approximately 400 epidemiologists at state and local health departments throughout the nation investigating food borne illness.

I wanted to make a few comments with regard to what has already been said. First of all, I do want to support a number -- the statement that have been made by a number of individuals regarding the importance of surveillance in the overarching goal statement. And we also feel that it is very important to add that as well to the statement.

As well, we wanted just to ask that in the first iteration of the strategic plans with the five different goals that were mentioned, or objectives that were mentioned, that have now become three, surveillance was in particular one of those original five. In the process of making it -- of going to the three, surveillance -- and the word surveillance occurs in a number of different areas throughout the document. We feel it is important to make sure that those are well defined.

I'm not sure surveillance is actually a very public term which a lot of the public might understand very well, unless we specifically state every time that it is surveillance for human health conditions. That is different from surveillance in laboratory mechanisms for surveillance of pathogens in food or surveillance as might be defined in many other ways by different groups who are involved. I think all of us sitting here understand that. But again, I am concerned about the translation to the public setting, what surveillance means and defining that.

In addition, I would also like to suggest that one of the action items be a clear understanding and agreement about what risk means. We all mention risk management, risk assessment. Risk is one of the more common words throughout this document. However, I think we need to agree, does risk mean that the priority conditions are those that occur to the greatest extent. Is salmonella or campylobacter, because it has -- there more condition -- more people becoming ill with that disease of higher risk than something such as e. coli, which has a greater mortality associated with it? So I think we need to agree in an action step exactly what do we mean by risk as a concept.

In addition, I wanted to suggest that one thing that we find missing in the plan is the translation of surveillance information to investigation and action. There is an awareness in the plan of the importance of responding to food borne outbreaks of illness. And there is a recognition that surveillance is important. What we are missing is the translation of that surveillance information into action and potentially into regulatory action as well.

So, for instance, what we see as a regular occurrence is we'll find ten cases of salmonella occurring throughout the state of New Hampshire. And it is depending on how aggressively we pursue those independent reports, how aggressively we pursue the laboratory methods to characterize them, to do the DNA fingerprinting, sometimes, whether or not recognize it as an outbreak or not. So we want to be able to place that concept in there.

I may also -- I was thinking of making some of these comments later. But seeing as everybody was standing up, I felt it was important to also make that mention here as well. And I think I'll end with that. Thank you.

MS. WAYLAND: Thank you. Now are there any other comments? I know that -- yes, sir?

MR. HIRSCH: I'm Martin Hirsch, the manager of the French Food Safety Agency. If you'll allow me, I will say a few words because I think it is very interesting to see that different countries have the same concerns at this period. And I was very interested to -- listening to the opinion which was expressed this morning, and maybe to give you a few words about our experience in France and in Europe.

As you know, in France, we created the Food Safety Agency ten months ago, and there is a draft in Europe at the European level to create a food safety agency. And I think that the reason why we did that in France and in Europe -- some reasons which were summarized this morning. The first reason is the new attitude of consumers, which are more demanding of more safety. This may be the same attitude, the same behavior that had consumers with malpractice, with -- diseases.

It is now a big fear, a big concern about the food safety, and some problems that we could tolerate a few years ago are not tolerated, not accepted now. And they want more safety. They want also more information. And they want also to understand how is the decision making process.

The second fact is that in Europe, like here, we are facing emerging risk. And the question is how we can be ready when these emerging factors are coming with new infectious diseases like BSE or new interrogation about some chemical products.

And the third reason is that we faced a major crisis with a huge impact on the economy and on the organization of the production. In some cases, there is no direct relationship between the crisis and its impact and the real risk. Sometimes we act to underreact, sometimes to react more, and to more -- because we were in a system in which we were not prepared to these events.

That is on this kind of analysis that we tried to reform our system in France. And I think it is the same way it is done on the European level now.

What are these principles? The first principle was to create an organization based on science with the responsibility for risk assessment on the global food chain, and then for all products which are animal products, which are vegetable products, which are drinking water, and from upstream to downstream towards a scientific community, which can be mobilized for this kind of problem.

The second principle was to have -- is to compare two different systems, this system with risk assessment, a second system with risk management. And if we organized a very close relationship between both of them in terms of exchange of information, as was underlined by some participants this morning, it is absolutely crucial that information at good time can circulate between all the people involved in that.

We tried to organize two different chains of responsibility, one responsibility for the risk assessment, independent of economic interests, independent of political interests, and to have -- to create a chain of risk responsibility for the risk management.

With the third principle, we just tried to make as transparency as we can -- as many transparencies as we can. And in the process, we tried to make that every scientific opinion expressed on the problem is systematically published so that the people and the consumers can say on which ground a decision can be taken. When sometimes you have -- it was, I think, underlined to take into account the scientific evidence, but sometimes also just the scientific uncertainties.

And sometimes the science doesn't give you every answer you would like to have. And so in the case, you have to take what the science can say and what it can't say, but also other factors, such as what are we able to do every level of the administrative and the economic action, and what are the consequences of the regulation on the new standards.

I think that addressing -- to seize it, we are facing exactly the same problems. And we don't know what is in terms of organization. But we see that there are a few principles which can be adapted according to what are the administrative organizations, what is the political organization. And you can't have a single model which can be applied everywhere in the world. But you can have some common principles. And I listened to things this morning which shows that some of these principles are the same in different countries. Thank you very much.

MS. WAYLAND: Thank you very much. I think we have heard a lot of different perspectives this morning and tremendously valuable comments. I would like to turn it over right now to Dr. Woteki because I think she has some questions of you based upon what we have heard this morning.

DR. WOTEKI: Yes. Thank you, Susan. I first of all want to say how impressed I am by, Dr. Hirsch, your remarks, and also by the fact that there are representatives here from many different countries. Clearly, our neighbors, Canada and Mexico, are well represented here. But there are personnel not only from the World Health Organization and PAHO, but also from many embassies, both in the western hemisphere as well as from around the world.

So I think that is an indication, as you said, of the importance of food safety in many different countries. And also, I think, a reflection of the fact that so many of us are either completing reorganizations of our federal or national approaches to assuring food safety, or are contemplating such changes. So we -- you are good to remind us that similar discussions are occurring in many different countries.

Also, I have been quite impressed by the statements that we have heard so far from the many representatives that are here from state and local governments. And there were two issues that came up in the sessions we have had so far this morning that I wanted to ask some questions back to you about. The first is that there are several comments that were made about is this a federal plan, or is this a national plan. And certainly from the task force's perspective, we view this plan as clearly representing the needs and the interest of a overall federal, state, local, and tribal government approach towards assuring food safety.

So from our perspective, this has to be a national plan. But also, because of the charge that was given to us by the President, we also need to be looking at the roles and responsibilities of the federal agencies and how we can better work with our state, local, and tribal counterparts. So at least my take away from the discussion so far has been that we need to do a better articulation of that focus.

But I would certainly like to hear if there are -- those of you who have not spoken so far, or those of you who have on this issue, what you see as the specific things that we should do in this plan's -- at this point, we are talking about the overall framework. But also, as we get into the discussions later on today, what are the specific changes that you think need to be made in the phrasing of the objectives and the action items?

So let me just ask at this point, is there anyone who would like to address the question since we are now talking about the overall framework of federal versus national plan, and specific changes that you think need to be made at the framework level.

MR. SOWARDS: Cathy, one of the things that -- this is Dan Sowards, AFDO. One of the things that I tried to articulate earlier was that by looking at it as a national plan and seeing where the resources are and the abilities are at the state and local area, that can help the federal agencies concentrate on where they need to most in particular to use their resources.

But at the same time, one of the things that I didn't articulate is how that plays into the framework of the strategy. And that is by looking at what the states and locals are doing and are able to do, or could do, then the federal agencies across those agencies can see more clearly, I think, where they can use their resources and not really duplicate what each other is doing.

An example that others have given over the last several years in particular would be the federally inspected meat facility that does non-meat products. I mean, there is absolutely reason to have two agencies doing an inspection in the facility. So -- and at the same time, I think you can also look at the distribution of products, whether they are FDA distributed products or FSIS distributed products.

If there is certain information, certain assurances of safety that the federal agencies need, you already have state and local folks that are going into these facilities and doing inspections, obviously, for a number of reasons. And I think it would facilitate an overall national plan and more concentration on resources, on risk, if there is this specific information, specific guarantee that the federal agencies need of the continuing safety of the products once they leave the processing plant. And if there is need for additional training, let's say, of state and local investigators, that that be one of the considerations that the federal agencies use in determining where their resources can most best be used.

DR. WOTEKI: So I would take it then that you would suggest that there be an action item that would be an assessment of resources, federal, state, and local, within the context of regulatory and statutory authorities, and then to identify ways that we could make better use of those resources and remove impediments to that.

MR. SOWARDS: Correct. In fact, one of the resource assessments that has been suggested and actually worked on by one of the national workgroups will address the capacity and the resources and the laws and regulations that are out there right now, that perhaps we don't have a total picture of at the present time.

DR. WOTEKI: Okay. Joe?

MR. LEVITT: If I could just follow up on that. As we look at this in terms of even more strongly covering the state and local governments in your contributions, are there things that should be added or included in here that would address ways to strengthen the state and local programs, whether it is in infrastructure or training or competencies or consistency or anything like that, that we could help, as you said, you can take back in the different states and say, yes, we need to do some upgrading here, too?

MR. SOWARDS: There are two or three issues that you have addressed in the document, but not strongly addressed, and I think perhaps a rewording of an action item or strengthening of an action item. And they are oversight, federal oversight of state, state oversight of local. I think that needs to be strengthened because if consumers are out there and are fearful that if anything is given up by the federal government to state and local, that it will weaken the system.

I think there needs to be strong oversight there to ensure that whatever the state and locals are doing is equivalent to what is envisioned of the federal government doing. I think the other issue is what you have said about looking at the laws and regulations, standards, that are currently at the local and state level that may fill gaps and are strengthening what you have at the national level. I think that needs to be reinforced.

And I think the third thing would be the resource assessment. And that is you need a strong statement in there about doing the resource assessment in determining where the resources are, and therefore determining how best federal resources can be used.

DR. WOTEKI: Okay. Stu?

MR. RICHARDSON: Stuart Richardson, California Department of Health Services. And just to add on a few comments, when I got up here I had some ideas that Dan expanded on. But why the discussion of the federal system, the national system, is important, as the federal ideas occur and change, there is significant impact to the locals, as everyone would expect.

We talked about the large resources that are out there already. It seems to me that the add on items here are objectives and action items dealing with not only assessing and trying to find out what is going on, but really marshalling and mobilizing all of our joint resources to those highest priority risk identified issues.

One of the statements which is in the document which I think is very good is another challenge is to allocate resources where risks are high. It can't be done only by a federal system by itself or a national system. We will never have enough resources collectively for all of us to do all of the things we think we might need to do at all levels of priority. So it is essential that in the document, past the overarching philosophy, which I think should encompass some of this thought, but in those goals, that there be specific objectives and action items in all three areas dealing with mobilizing, marshalling, or action statements that say that we are going to reach out and not only identify the resources, but we are going to build them into a system and utilize them so that those resources are going to the highest priority as well.

MS. DeWAAL: This is Caroline Smith DeWaal, with the Center for Science in the Public Interest. I think the comments and what we are hearing from the states is very good. But I want to caution the panel that it is not acceptable from a consumer standpoint to have the federal government simply turn over parts of its responsibility for food safety to the states.

There are issues around state regulation that, you know, are just there. There is a very close at times political relationship between the regulated entity and potentially the governor, who may impact how a particular plant is being regulated. We have tremendous concerns about that. We are also very concerned that the state budgets cannot -- can vary from year to year. And we can find food safety inspections being dramatically cut back in a year based on a particularly tight budget that year at the state level.

That is not a reliable system. We need -- at the same time, the states have jobs which they are already responsible for, things like we have heard a number of times today. They have primary responsibility for inspecting restaurants, hospitals, schools, nursing homes, and other places where food is prepared. And in many instances -- we have done a study on this. Those jobs are not being adequately done today.

So I think it is very important. I recognize the tremendous job the state has done in filling in the gaps, particularly in FDA's inspection program. But that is not the system of the future. The system of the future is one where we need a uniform, across the board inspection program that consumers can rely on with the states knowing what their jobs are and knowing what their responsibilities are so they can apply their resources appropriately so they can budget appropriately.

And I have tremendous concern. While I support entirely the work the states are doing on food safety, we need a coherent federal system into which they know where they can best do the job.

DR. WOTEKI: Thank you. In the interests of keeping us on time, since we have such a busy agenda today, I would like to then pose a second question and ask people if in the written comments that you will submit, you could pay some attention to this question. And a number of commenters have talked about the lack of measurable outcomes.

One of the things we are particularly interested in hearing from you would be what concrete outcome measures would be appropriate for the overall goal for this plan. Certainly, as our task force will be moving after this meeting, one of the things that we have set for ourselves to do is to develop the action plan that would essentially go along with the strategic plan, and that action plan would have measurable performance objectives. It would have a timetable associated with it. But at the level that we're talking about right now, which is, you know, the overall, overarching goal, are there some performance measures that you think would be appropriate to use in evaluating our progress towards that goal?

So we would particularly be interested in your comments on that. And I might say, as we go through the rest of the discussion today, if any of you on the action items, objectives, or the specific goals as we are going through have got recommendations for performance measures for any of those, we would also welcome your comments on that. Okay. Thank you, Susan.

MS. WAYLAND: Thank you.

DR. WOTEKI: The next discussion is going to be moderated by Dr. Gabriel.

DR. GABRIEL: Thank you, Cathy. It is my privilege to talk about some science, one of my favorite topics. Clearly, the National Academy of Sciences, many of the organizations, individuals have really driven this message home to us loud and clear that the food safety system needs to be based on good science, sound science, credible science, and also on a good system of risk assessment. And this goal, objective and objectives and action items really is our attempt to try to get to that.

So I guess what I would like to do is follow suit with Susan's approach here, go around the table, and then go around the room and get your comments. So why don't we start over here?

MS. SOSA: -- right now. Are we going to address all of our comments with regard to each of the objectives and action items at this time?

DR. GABRIEL: I think that is the best way to go.

MS. SOSA: Okay. One of my concerns --

DR. WOTEKI: Can you identify yourself, please?

MS. SOSA: I'm sorry. My name is Meryl Sosa, and I representing Food Animal Concerns Trust. One of the main concerns that I have about the document overall, and particularly objective three, is that I wondered why the focus under the final action item is limited to water used for food production and processing. And I wondered what about water use for humans. And it would seem that safe water is an important area to be considered in this area.

And one of the things that concerns me is I recognize that EPA is represented in the pesticide area. But there is no representation with regard to animal waste. And our organization views this as being part of the farm to table continuum. And, for example, objective three mentions animal feed. Well, one of the items that is often included in animal feed is animal waste, for example, poultry litter or things like that.

And we have a concern that there are no regulations of this whatsoever. And even in the guidance manual and the example permit for concentrated animal feeding operations, the review draft that was issued in August of 1999, there is no mention of this at all. And that has to be considered because studies have shown that antibiotic resistance can be transferred through, for certain, poultry litter. And therefore, this scenario is relevant to consumer health.

So we feel that that is a really big consideration. And also, we know from studies that e. coli 0157:H7 can survive for substantial periods in the soil. And we don't know what impact that has on our crops or on the water because it can filter through into the ground water, which is also not covered by the manual. So we feel that animal waste is a big area, and it is not addressed in this document at all. So we would like to see that be considered.

The other thing that we would like to find out is how transparent the process is going to be as we progress because we would like to know whether consumer groups are going to be able to provide input regarding research needs and gaps as they perceive them, and not just as perhaps regulators and academics and industry perceive them because we may not have the funding to be able to do the research. But we would like to see some areas that we feel are important be addressed by research. And we would like to know how we can be included in that process.

And we would just like to note that there were apparently two meetings in December for, I guess, professional organizations and industry organizations, and consumer groups were not brought into that forum. And we are a little concerned about that because last summer we were brought in, and everybody had an opportunity to speak to the issues. But then, in December, we were somehow excluded from that, those considerations. And there wasn't a separate meeting held for us or anything like that.

So we just kind of w