U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition

Opening Remarks

MR. LEVITT: Good morning and welcome. We put out a Federal Register notice about a month ago and we are delighted with the response we have got. We have a very good cross-section of speakers. I would encourage people to not stay only for your presentation but I think an important part of the day to listen to everybody else's also.

There is an agenda that has been passed out and so people can see where they fit on that. We will have up here, along with me, a rotating set of panel members from the senior staff in our center.

Just before we get going and I introduce Dr. Friedman, I just want to take a moment and thank the staff that worked very hard to put this meeting together; Tracy Summers, Lynn Guzens and her entire group from the Office of Constituent Operations. If you could just stand for a minute.

Without further ado, I think we should get going. It is my pleasure to introduce our Acting Commissioner, Dr. Michael Friedman. I can tell you he is someone who cares deeply about the Food Program, has been very actively engaged and is going to slug me if I go on any more.

DR. FRIEDMAN: Thank you. My interest in the Food Program is an intensely personal one. But I also have a programmatic interest as well. Let me thank everybody for being here today. I would like to take just a few minutes at the beginning of this program to go over some general issues that I would like you to think about.

This public exchange of ideas comes at a critical time for CFSAN and for the agency. I appreciate people's willingness to participate. With the launching of the President's Food Safety Initiative last year, the attention paid to the quality and the safety of the nation's food supply has never been higher.

There are good reasons to focus on this issue. Insuring the nation's food supply is an increasingly complex task. The agency faces growing numbers of imported products, both raw and finished products, the emergency of new food-borne microorganisms, changes in the demographics of our population as we age and as we eat out more. All of this focuses attention on CFSAN, its activities and its needs.

While the Center has received additional resources under the Food Safety Initiative in the current budget and we earnestly hope we will receive more next year--but that is a matter being considered by the Appropriations and other committees at this moment--we need to look beyond mere budgetary considerations in thinking about the ways in which to help CFSAN best fulfill its missions.

That is what you will be spending the next bit of time discussing. I, personally, look forward to hearing the results of these discussions.

What I would like to address, though, this morning, very briefly, is sort of the technical basis for this meeting, that the agency as a whole and the relevant interest groups, both consumer and industry, need to communicate more frequently and more effectively to deal with issues of joint interest.

This kind of consideration certainly has been ongoing and I am not suggesting that it is a novel idea, at all. Already, there are a number of points of contacts and communications and these have improved considerably recently. But, as the voice of our populus, Congress wants us to do an even better job and our own staff wish to do an even more effective job.

Last year, in the FDA Modernization Act, Congress gave the agency many important tasks. I would like to talk about just two of those tasks specifically, now. First of all, FDA was charged with formally assessing the discharge of its statutory obligations under the Food, Drug and Cosmetic and Public Health Service Acts, and then determining if there are any obligations that the agency fails to completely fulfill.

This analysis has been initiated and it is ongoing now. As part of that evaluation, Congress directed FDA to consult with, and here I quote, "appropriate scientific and academic experts, healthcare professionals, representatives of patient and consumer advocacy groups and the regulated industry.

In other words, what I am doing is soliciting your input as to what FDA is not doing as well as it should and how we can improve. Once this analysis is complete, FDA is directed to develop and publish a plan for achieving compliance--and here, again, I quote--with each of the obligations under the Act.

The first edition of this published plan for addressing these shortfalls is due in November of this coming year, November of 1998. We have a great deal of work to do in the next few months under this obligation. For those of you who are interested, it is referred to as Section 406(b) of the FDA Modernization Act.

So I am inviting your participation today. We have a lot to do and relatively little time to do it. I hope that today's meeting is an example of the kinds of consultations that Congress had in mind. The Agency benefits very importantly from the input of those who are knowledgeable and who have a stake in the effective operation of the FDA.

You have a perspective about the things that the agency is doing well and the things that we are not doing as well as we would like and areas where we can improve. Clearly, we do not currently have sufficient resources to do everything conceivable. So this evaluation must be balanced, risk-based and key to the best public-health value.

I ask you to think broadly about FDA's mission to promote and protect the public health, help us find the right combinations of initiatives and improvements that can advance our mission. Proactively, the agency, itself, has begun to identify areas where we would like to see improvements made.

Some of these are obvious areas. Some are less obvious, but all are fairly complex. Let me, if I may, raise three of them for you that we have identified, not to limit your thinking but to give you a sense of the kind of priorities that we see important and to welcome your input.

First of all, application reviews. This is an important invisible process for FDA. There is an enormous effort prior to the filing of an application, and I recognize that. But reviewing an application to market a new product is a major activity.

I think you are aware of the fact, and let me recall for you, that the agency's workload, as measured by new applications of all sorts, not just food but of all sorts, is increasing at the rate of 12 percent per year for each of the last five years.

That is a remarkable growth. What that means is that every six years, the agency's workload for new applications doubles. We have every expectation that that rate of increase will continue or, perhaps, even accelerate.

In programs not covered by user fees, such as blood products, animal drugs, generic drugs, medical devices, and, of interest to this office, of course, food additives, the agency, despite our stable budgets that we have had in the past, faces erosion of its ability to perform this job.

We need to find solutions to demonstrable gaps posed by the steadily rising workload in the face of static budget projections and the recognition that, for example, with food additives, we are not meeting our statutory deadline of review times.

Now, product quality-assurance is a second area that I think is important to this audience. It is really highly relevant to many of the considerations that you will have. How does the agency assure the high quality of the products that we regulate. At the beginning of this decade, the average inspection, and now I am talking about all kinds of problems, for FDA was 17 hours at a facility.

Last year, because of rising complexity in the correction processes and other considerations, the average inspection more than doubled, 36 hours. In 1990, FDA processed nearly one-and-a-half million shipments of regulated imports. Today, that number is 4 million and, again, it is going up dramatically.

Essentially, we have had the same number of staff working on these considerations. Through management changes and improved efficiencies, we have struggled to keep up. I think we have done satisfactorily. What I am concerned about, however, is that we will not be able to continue to make these kinds of performance gains in the future.

We need to find better, smarter, faster ways to insure the quality of the products that are under our jurisdiction. This is one of things that I ask you all to help us focus on.

Let me mention a third area, if I may, and that is adverse events and injury reporting. I think this is a truly critical issue. Recently, an article in the Journal of the American Medical Association pointed out the large number of people estimated to either die or be made ill by the use of drugs. These were drugs that were properly prescribed and properly used.

Nonetheless, this was an important consideration. The economic costs associated with medicine errors is very, very substantial. There is mis-use or improper use of medical devices. There are errors and accidents associated with biologic products and we are struggling to deal with the large number of new products and new uses for those products for the American public.

I think that this has less direct import for foods but it is not completely divorced from foods. And I ask you to think about these things. These are three large areas that the agency has identified as deserving greater attention.

There are some themes that are woven into that. Let me just mention a few of the background themes, if I may. The first and the most important here, something that is integrated into all of these efforts and underlies everything we do is our desire, our need, for greater scientific expertise within the agency.

Please recognize that the National Institutes of Health continues to pour more than $13.5 billion a year into basic and applied biomedical research. It is hoped, it is estimated, that that amount of money will double over the next five years. That is a widely held consideration.

At the same time, pharmaceutical companies are investing $21.6 billion a year in research and development. Medical device manufacturers, another $4 billion a year. I don't have good figures for the numbers invested by the food producers or manufacturers but, clearly, we are talking about an incredibly robust period of scientific research.

What this means is that, for each dollar invested in research and development, there will be a downstream effect on agencies that must regulate those products, like the Food and Drug Administration. First of all, there is going to be this vast flow of products but, secondly, and equally importantly, these products are going to be novel products, new mechanisms of action, new ways in which they are produced, and they present new scientific problems to the agency.

If the agency is not fully competent in science--I don't mean just conversationally competent but thoroughly competent--if we are not, then we will fall behind in our ability to make timely, accurate, rational, science-based, public-health judgments and decisions. That would be a great disservice to the American public.

We don't want to slow the development process, but we want to do a very good job in discharging our responsibilities. We are going to work hard to have the agency scientists, but the clinical scientists and the laboratory investigators, continue to have their own scientific expertise, to have access to be able to do their own clinical studies and laboratory studies and to remain at the top of their field.

This is a very important consideration for us. We will work hard to enrich and maintain scientific relationships with our sister agencies, especially CDC and NIH, but all other parts of government as well including USDA. Important linkages need to be made to form regulatory bodies, important linkages to academia and important linkages to industry as well. That kind of collaboration with all those parties will be necessary.

There are a couple of other themes that I just want to mention to give you the full range of responsibilities here. One is a continuing need for outreach and information. Increasingly, FDA is becoming a purveyor of information. While we are an agency that has regulatory authority, and the power to enforce the law, our decisions are based upon science and we recognize that a large number of the things that we wish to do require good information to be provided; provided to the producers, industry, provided to consumers so that we have the best scheme that we can.

I think that is one of the reasons why the guidance documents, the other sorts of guidance that we provide, are so critical. Additionally, it is very important that the public receive good, reliable, understandable information on how to use the products properly. This is a huge responsibility but one of our most important missions.

How we can do that better, I think, is a real challenge for us, whether we are talking about nutrition or how to properly use a prescribed medication. I think the need for public education is very important.

You recognize that we have important responsibilities in the food-safety activities. I have already mentioned some of those. This is one of the highlights of the administration and one of the most important things that CFSAN and the agency are engaged in.

No discussion would be complete without at least a brief mention of tobacco. This is an important public-health issue for us. There are several components of our activities that have been ongoing and will continue to be ongoing. The courts have been supportive of us in that regard and our efforts to reduce underage smoking will be an important activity for the future and an important investment in the nation's public health.

I don't want to just mindlessly catalogue a list of everything that we are doing. That is not my intention. My intention is to give you a framework in which to think about the kinds of things we would like from you and ask for your specific input.

In the weeks and months ahead, we will be meeting with stakeholders, constituencies who are affected by the agency's decisions. These will be public meetings. There will be discussions with representatives of various groups. We want to have a lot of input but we don't want a totally open-ended process that could be messy, difficult to interpret or not guiding us in a useful way.

There are three considerations here. The first is that FDA does not expect the meetings to find specific solutions for all the challenges raised by FDA modernization. Give us the best advise you can. Recognize that it is interim advice but the best advice at that moment.

The second is these discussions will be open. The agency is very receptive to constructive input and proposals. This is not a sham operation. The third is that we will make every effort to include the views of stakeholders in new proposals, but we recognize that, at any moment in time, there is going to be some tension and it will not be possible, of course, to satisfy everybody's desires.

At the same time, we recognize the decisions and plans that are made today may be very useful today but may not be useful in the future and we will have to continue to revise those. While we are setting up these mechanisms for taking in and analyzing the comments, we have already established the traditional docket to record input and ideas that people would like to submit to us.

May I give you that docket number. That docket number is 98N0339. We don't have a way of electronically assessing, inputting, these comments but you can mail or fax us any comments that you have. Our fax number is 301 827-6870. You can mail your comments to the FDA dockets management and I think many of you have done this in the past and are familiar with that.

If you miss that, it will be available at other times and I don't mean this to be the only opportunity. But I do want to say that we welcome your input in that regard. These are very important issues, in general. The issues that you will be struggling with and discussing are, obviously, very important and very complex as well.

I look forward, very much, to hearing about the input from these discussions and what suggestions you will have from us. And I beg your indulgence after the very good advice that Joe Levitt gave, that people should stay around for more than just their presentation. I am not going to do so and I apologize for that very much because I am supposed to be someplace else. But it is still good advice and you all should follow it and do it.

I do appreciate this chance to give you these few remarks. I do appreciate your willingness to work with us and provide the kind of input that this open meeting promises to convey.

Thank you all very much for your efforts.

MR. LEVITT: Thank you very much for trying to set the tone for the meeting and for kind of giving an FDA-wide perspective. I know it is hard, from somebody who has worked in or with just about every FDA program, I recognize that it is hard to really give a good FDA overview because everybody is focussed on their areas. But we thank Dr. Friedman for doing that.

Overview of Research A llocation/Resource Needs

Let's, now, start to focus more in on foods issues directly. I will talk just a second on the importance of establishing priorities. A number of people have heard me in my various talks this spring, what somebody jokingly called my stump speech, where I have talked about values, vision, priorities and challenges.

I often give the example of too many of FDA's activities are like we are trying to take a hundred pebbles and push them up a mountain an one mile an hour and, after fifty years, what do we have to show for it. We have got a lot of pebbles halfway up the mountain and nothing over and, really, nothing to show for it.

So I really am going to try to take the opposite approach, to identify what I call several boulders, get them up and over the hill, to focus, to finish and to move on; that is, I can say something that all of FDA copes with, certainly the Foods Program is no stranger to that, but it is an important thing we are going to try to do.

Really, when you stop and think about this meeting, what I would like you to do is help us identify what those boulders should be.

I have a couple of slides I want to run through to kind of further set the stage. You will enjoy the splendor. This meeting room is what they call a BYOS, Bring Your Own Screen, and so we are a little into home movies here.

[Slide.]

In terms of what we are trying to do today, we are trying to look at priorities across CFSAN. I have asked people to focus outside of Food Safety Initiative because there have been lots and lots of public meetings focused on Food Safety Initiative and I want to kind of make time for everything else.

To the extent that people want to talk about food safety, that is fine. I would just ask you to focus on FDA-specific issues and not issues involving other agencies. As Dr. Friedman said, this also is part of our general fulfillment of the mandated under the Modernization Act to reach out and meet with stakeholders.

[Slide.]

I have got a couple of graphs that I want to run through, and let me take a minute with it. I tease myself about when I was asked to take over the program, I had worked in FDA for twenty years. I know exactly how big CFSAN was. CFSAN had 1,000 people. I knew that. Everybody else knew that. I guess I must have a time warp for when I started because when I started, twenty years ago, in 1978, sure enough, CFSAN had 995 people. I am going to round up and call that 1,000.

But what has happened, and this chart just covers full-time equivalents or essentially people in the program, but, in FDA, in general, and Foods is similar to that, virtually all of our money is in payroll. So this very much reflects at least how we see our resource base.

The first think you see is that, for ten years, there was a cut every year for ten years. That was part of the general downsizing of government during the 1980s but you can see it hit the Food Center particularly hard, and you can see one year in the middle which was probably the Graham Rudman year, if we look back, for when there was even a steeper cut than in other years, but a ten-year constant decline.

The second thing that is not obvious but I point out is in the middle, where you start seeing some increases, they were very targeted increases for very specific reasons. And so there was an increase for imported foods. There was an increase for seafood. There was an increase for NLEA for Nutrition Labeling and Education Act, and there was a most recent increase in this year for Food Safety Initiative.

Even with those increases, we still have 20Êpercent. We are still started this year at 791. We still are 20 percent smaller than the memory I had which is probably the memory that a lot of you have because the FDA budget is presented more as a whole or as a foods program which includes the field. And it is hard to tease apart for public understanding of what the resources of the center are.

So that is one thing to look at. Now, there is another thing to look at which is how much people in the center look at it.

[Slide.]

If you take out those four areas that I mentioned, if you take out the increase of imports and seafood and nutrition and Food Safety Initiative which are important but, nevertheless, very specific increases, if you look at the general base of the program--so if you are working in food additives, if you are working in color additives or cosmetics, if you are working on Codex or if you are working on food standards, you are working on pesticides, you are working on the Milk Program, you are working on any number of activities, this is how your world looks to you.

You don't have a 20 percent decrease, although that would be enough. You really are down to 666. You are really down to a full 33 percent decrease. As I said, if you talk to people in the center, that is just naturally how they feel because that is how their program has gotten cut, on average; some more and some less.

[Slide.]

Now, at the same time, of course, while budgets were going down, additional responsibilities were being given to us, and this lists the major pieces of legislation involving the Foods Center; infant formula, pesticides, nutrition and labeling, dietary supplements, Food Quality Protection Act on pesticides, and, of course, the Modernization Act from last year.

So we have those sets of FDA and food-specific legislation. We also have, as companion to that but it is kind of hidden, all of these general international trade agreements which carry with them their own additional responsibilities. This is something that I know that has had a lot of interest outside, but I can say it is kind of below the surface because it doesn't say Food and Drug on it.

It doesn't say Food Safety on it. It says, WTO. Or it says equivalency. Or it has words like that. But what that means is that those also are additional obligations we are having to do.

So what FDA is realizing more and more is you put all of this together and you can't help but reach the conclusion that there are significant gaps from what we have, in terms of resources, for what the world's expectations are. There is a gap between the ability to deliver and the expectations to deliver.

So what we need to do is we need to try in helping to bridge that gap. One of the areas is, "All right; what are we going to do?" I was at a meeting. I was down at IFT in Atlanta earlier this week and I kind of walked in at the end of the one of the presentations because I was on the next panel.

One of the presenters, just from a food company in charge of research, said, "You know, in my research program, I have got to set priorities. That means that some of the things that people want to do aren't going to get done but it means some things are going to get done well." I said to myself, "Wow; I want to tape that. I want to replay it at the beginning of our public meeting on Wednesday," because that is exactly the theme that we have to do if we are going to succeed.

[Slide.]

In terms of priorities, people ask me, "What do you mean by priorities?" When we looked at regulations, this is kind of how we have scoped it out. We say, number one, if it is a regulation that is going to enhance consumer safety, that has got to be first.

That is, after all, why we are here. That is why the Food and Drug Administration exists. That is why the Act was passed in the first place. That has got to be our top priority and a lot of the Food Safety Initiative issues you will see in there.

Number two, what is mandated by statute. Number three, health-related labeling, nutrition issues, health claims and so forth. Four, things that improve efficiency, something, I would say, like our proposed GRAS notification process of a year ago. That is something that is going to improve efficiency. It is going to help the whole system run well. We need to give priority to that.

Finally, not withstanding those four categories, there will be other things that have major positive impact and we want to be able to identify those. Again, that is what we want you to kind of do with us today.

[Slide.]

We have listed six questions in the Federal Register that I want to call people's attention to and hope that you will try to address as we go through. Number one, are there safety issues not being adequately addressed. If there are, we want to know it. We certainly think that the Food Safety Initiative and other things, we have that covered. But, if we don't, please tell us. We want to know.

Number two, what should be the top priorities beyond the implementation of the President's Food Safety Initiative. In all my other speeches, I have a slide that says, on priorities, when you have a Presidential initiative, you know it is first. It is food safety, food safety and food safety.

But, beyond that, we have an entire program of activities. What do you think should be the priorities beyond that. Criteria; do you like the criteria I just put up or do you think other criteria are more appropriate.

[Slide.]

Four, what are the highest priority areas for research. We believe that it is essential to have a science-based program and that research is a critical part of that. But we can't do everything. Where can we best direct our research efforts so we are getting dividends, things that are unique that need to be done here that are not being done other places and are critical to our mission.

Number five, international activities, what is the priority of those. I mentioned WTO, equivalency, Codex. I think we recognize these are important but also they are expensive, they are far away, they take time. Where can we best target our efforts so that we get the most payout out of it.

Finally, I asked a question about economic fraud and the food supply or economic issues generally, where do they fit? They are not safety issues. We know they are competitive issues. But I get a fair amount of questions on that so I thought I would put the question out, where does it fit in the scheme.

[Slide.]

We are establishing, and this meeting is the formal kickoff of it, what I call an open participatory priority-setting process for Fiscal Year 1999 and beyond with a goal of establishing blueprint for our priorities. We will be taking today's and tomorrow's meeting and following through internally through the summer in our priority process, and we will be putting something out this fall for foods in addition to the general plan for Congress that Dr. Friedman mentioned.

[Slide.]

Finally, I want to just jump back, if you will allow me, very quickly, to leave one slide up there for a couple of minutes, which I misplaced as I ran through the slides, and that is really what does all this come down to? As we are looking across the Foods Program, the central issue I want to keep coming back to, and folks can prepare themselves for, because when you are sitting up here, it was going to keep being my question, where do we do the most good for consumers.

That is why the FDA is here. Where do we do the most for consumers across all these areas. That is why I keep focussing on safety. That is why I keep focussing on health-related issues. Please help us focus on that and where we are going to do the most good for consumers. That is, I think, where we will be successful.

That completes my slide presentation. Let me just say a couple of other things and then we will get the meeting kicked off. This is how we are going to do this. People have the agenda out there and so what we are going to do is we will have a series of panels--I hate to call it Congressional hearing style because I hope the atmosphere is considerably different.

But, nevertheless, we have tried to group people that have similar kinds of issues that will be doing presentations as a group. We will have, up here, sitting along with me, a rotating panel of senior staff from our center.

What I would like to do, and this is maybe a slight modification, is when we get up here for each group, I think I would like each presenter to do their presentation and then we will have question and dialogue as a group. There will be a little bell and a little sign that goes off as your time. We would like to try to keep to the schedule as much as possible.

We also will have a written record. We both will be doing a written summary of the meeting, both for ourselves and we will put that in the docket. In addition, we hold the docket open for 30 days following this meeting for people to submit written comments. So both for those that are here, if you want to get your official submission in, please send it in for that.

If you want to supplement, based on other things you hear, we encourage that. If you want to go back and talk to your friends who weren't here, we encourage you to do that, to. So the written submissions will all be looked at in, really, each area.

We will have here, at the meeting, a representative from each office and each part of the program is very interested to what you have to say.

With that, I think we will take a quick pause. I will invite up the FDA staff on the first panel and we will introduce them, I think once they are up here. So you know who you are. I will introduce them as they are coming up. Janice Oliver, who is our Deputy Director and heading up our Food Safety Initiative. Bob Lake, who is our Director of Policy. Phil Spiller, our Director of Seafood. And Terry Troxell who is our Acting Director in what we finally refer to as land food--plant, dairy and beverages. So we have land and sea.

We also have to ask indulgence for our dear Janice Oliver who has laryngitis. So, as many of us will be asking questions, Janice's assignment today is to take good notes and to pass to Bob or me for questions.

With that, let me then invite up our first panel, representatives from the states. We have Joe Corby from AFDA, the Association of Food and Drug Officials, and Ken Moore from the Interstate Shellfish Sanitation Conference.

I would welcome Mr. Corby.

Panel 1

State Affiliations

Association of Food and Drug Officials

MR. CORBY: Good morning, everyone. My name is Joseph Corby. I am the Assistant Director for the New York State Department of Agriculture and Markets, Division of Food Safety and Inspection. I currently serve as the President of the Association of Food and Drug Officials. I am pleased to be the lead-off hitter this morning.

I may be the only state official to offer public comments today and tomorrow but I hope that numerous state and local jurisdictions will provide written comments in this important effort.

Before I begin, I wish to remind everyone of AFDO's visions for a national food safety regulatory system. This vision is one we refer to as a vertically integrated national effort and it is something which I have assured AFDO's state and local government partners that I would aggressively promote during my tenure as president.

It is a vision we are so strongly committed to that my appearance here today was so important for AFDO because we believe the cornerstone of this vision of a national food safety structure begins with leadership provided by federal agencies.

This leadership is absolutely necessary for the success of a vertical top-to-bottom system. It is this leadership that we have always associated with the Center for Food Safety and Applied Nutrition. Every comment that I have received from AFDO board members, which I used to prepare my remarks today, listed, first and foremost, the need for CFSAN leadership.

AFDO concurs with the FDA work priorities as listed and agrees that food safety must be the highest priority. In addition, AFDO strongly supports those programs linked to the President's Food Safety Initiative. What AFDO suggests today are broader than programs and larger, in scope, than merely a top-ten list of priorities.

The suggestions we offer are a result of current-day concerns of state and local regulators. Please remember that while the national debate on food safety continues and while we look for answers and solutions to food-borne illnesses, state and local regulatory officials must act immediately even if it means employing interim policies.

Time might be useful in developing strategies during the debate, but it is a curse for those who must act today. Accordingly, AFDO is pleased to offer the following comments concerning CFSAN program priorities.

Number one; CFSAN must be the scientific leader in food safety. In a vertically integrated food-safety system, AFDO recognizes the scientific expertise located within CFSAN and the reliance that states have on this expertise. However, there are numerous occasions when requests for assistance, both oral and written, are not met with a timely response and, on occasion, met with no response at all.

It is incumbent on FDA, with the states as equal partners in food safety, to respond to such requests in a timely fashion. AFDO further believes that a formal procedure should be established whereby FDA can respond or give information to state programs. Perhaps reduced resources in the center has created this problem, but it seems today that state and local governments do not have a central liaison within FDA to get needed information.

Contacts are arbitrarily made with FDA districts, FDA region folks, region milk, food or shellfish specialists, the Division of Federal State Relations, and the Office of Regulatory Affairs when it would be so helpful if we could establish a singular contact liaison.

Number two; CFSAN must be adequately funded and staffed to continue research. Government regulators are often criticized for being reactive instead of proactive. In my home state, I have been involved with botulism outbreaks associated with uneviscerated fish and fresh garlic packed in oil.

We were reactive to these circumstances and, together with CFSAN, took appropriate counter measures. Research provides us our greatest opportunity to be proactive. For instance, it was CFSAN that cautioned state and local programs about the botulism concern with overwrapped fresh mushrooms.

CFSAN's research, as you recall, was a botulism challenge study which demonstrated botulinum toxin could develop prior to sensory rejection of fresh mushrooms. The research concluded the necessity for oxygen to be available at all times within this package. As you know, the application of small holes in packaging materials allows this to occur. This is an example of where government was proactive through the use of research.

Number three; CFSAN must expand the application of HACCP. Approximately six years ago, FDA determined that HACCP and the food process industry was essential. A HACCP core committee was created and included state representatives that had been recommended by AFDO. HACCP pilots with various food-processing companies were started to evaluate the effectiveness of the system.

Seafood HACCP regulations have been developed and implemented and mandatory HACCP for the juice industry is being considered. It is AFDO's understanding that HACCP is performance-based and, therefore, applicable to all food-processing industries. Since states are obliged to keep pace with FDA and the regulation of food safety, it has been incumbent upon the state to adopt federal food safety regulations as either state regulations or law.

The current approach to HACCP by FDA appears to be piecemeal in a sense and is an increasing hardship for states which must go through the burdensome rulemaking process to promulgate new regulations. This is, frankly, probably one of the main reasons FDA's food code has not been adopted in a more timely fashion.

AFDO recommends that CFSAN consider reassembling the HACCP core committee for the purpose of determining whether a universal HACCP regulation for the food-processing industry is warranted.

Number four; CFSAN needs to redirect resources for economic fraud and mislabeling issues. It is clear that the Nutritional Labeling and Education Act corrected the misdoing of the 1980s relative to false and misleading advertising. AFDO is deeply concerned that economic fraud issues has reared its ugly head once again and there appears to be a general lack of guidance and concern from FDA on these matters.

To compound the problem, states are preempted from setting standards or related labeling requirements and little is being done. AFDO does not believe that we can allow the industry to make whatever label claims they wish in order to suit their competitive market needs.

Eventually, government will be required to reenter the arena to clear up the labeling mess, just like they did with NLEA. AFDO believes that it is necessary to redirect some CFSAN resources, if only on an interim basis, to insure that we do not return to the situation created by FDA inactivity in the 1980s.

Fifth; CFSAN needs to work with state programs to monitor imported foods. At current resource levels, FDA is unable to properly monitor imported foods. In AFDO's vision of a vertically integrated regulatory system, FDA must devote more attention to import matters while states deal with domestic concerns.

Currently, imported foods affect both federal and state agencies with too much resource expelled at state level to deal with illegal or defective imports that have found their way into domestic channels. FDA should work with states and develop strategies on how best to insure the safety of imports.

Partnerships and cooperative agreements are only effective on an interim basis. AFDO believes new legislation and additional funding will be needed to fully implement a vertically integrated national food regulatory system.

As I close, I must say how important CFSAN has been to AFDO. Please understand that whenever we look for food safety solutions, for interim guidance or direction, and whenever we need scientific assurance that our cause and objective is appropriate, we look to CFSAN. We want to continue that relationship and I thank you for the opportunity to share these thoughts with you.

MR. LEVITT: Thank you.

Ken Moore.

International Shellfish Sanitation Conference

MR. MOORE: Good morning. My name is Ken Moore. I am Executive Director of the Interstate Shellfish Sanitation Conference. The ISSC has a long-standing working relationship with the Office of Seafood and CFSAN and it is certainly a pleasure to be here to provide comments today.

I have worked with CFSAN for a number of years, but I must admit that, in my review of the appendix to the Federal Register notice which includes the center's list of major activities, I was awed by the magnitude of this list. I do not envy the task you have before you, but I must compliment you for your decision to hold this meeting.

Beyond the value of the information you find helpful in the comments, this meeting will help to educate all of us regarding the extent of CFSAN's activities. Should you be unable to implement a particular recommendation, the participants here will have a better understanding of why.

First, I will address the six questions you included in the Federal Register notice and then I will make some general comments regarding priority setting. I polled the 20-plus members of the Executive Board of ISSC and their views have been incorporated into these comments.

First; are there issues directly affecting consumer safety that are not being adequately addressed? The answer is yes, but, in saying that, I am not saying that they are not receiving attention. I am going to mention three; first, sporadic outbreaks of Norwalk viruses have been attributed to overboard discharges of human waste from boats. It is receiving attention, but, in terms of a solution, the solution that we have found, we aren't sure of the success it will have.

A second is vibrios in shellfish, not related to human fecal contamination. But I don't think the biggest problem is Vibrio vulnificus. The incidence rate for Vibrio vulnificus is between 20 and 30 annually and it predominantly affects immunocompromised individuals. About 80 percent have liver disorders.

Another vibrio, Vibrio parahemolyticus, on the West Coast last summer; parahemolyticus affects all consumers and is not restricted to the immunocompromised although the health implications are more serious for those with underlying health conditions.

These issues are receiving considerable attention and will be major areas of discussion at our annual meeting next month.

Two; which programs and/or activities do you believe should be taught priorities for CFSAN? The first priority should go to programs which directly impact food safety for the general population. The majority of these programs appear to fall into the product safety assurance and outreach programs. Other priorities should focus on support for the programs such as research and enforcement.

Three; should the same criteria be used to set priorities for CFSAN regulations be used for setting priorities in other programs? The priority list that Joe Levitt talked about seems practical, but the emphasis should be on process which affect the health of the general population.

Four; what should be the highest priority areas for conducting research? I have listed three; alternative indicators, rapid methods for specific pathogens and biotoxin identification and risk-assessment models would certainly be helpful for future priority setting.

What level of priority should be given to international activities? This is a difficult issue. Compared to domestic foods, less is known regarding the safety of imported foods. States and local food-safety agencies cannot effectively address hazards in imported foods.

One executive-board member had concerns regarding the safety of imported thermally processed shellfish specifically questioning the effectiveness of processing practices and the adequacy of biotoxin monitoring in foreign countries.

Monitoring of imported foods should provide more information for identifying problems and programs for addressing these problems. The amount of imported foods should also be given consideration in establishing priorities for international activities.

Question six; what level of priorities should be given to economic fraud issues. Again, the focus should be on general-population food safety. While this area needs considerable attention, priorities should be directed to fraud issues which have food safety implications.

With respect to shellfish issues in the National Shellfish Sanitation Program, specific areas which need attention include HACCP implementation, which will require training, technical assistance and modification to the National Shellfish Sanitation Program standardization effort.

Two, program evaluation criteria and training to insure consistency and uniformity in state programs. With respect to cooperative programs, this concept offers FDA an opportunity to utilize the resources of state and local agencies to accomplish food-safety goals. Your behavior in these programs dictates your success. I advise you to not underestimate the public-health contributions of state and local food-safety agencies.

The food supply in the United States may be the safest in the world. State and local governments have played a significant role in this achievement. The Food Safety Initiative and federal-state partnerships movement have left some state public-health officials feeling unappreciated and alienated.

You share common responsibilities and, in future efforts, I suggest you find ways to nurture your relationships in cooperative programs. They will play key roles in the success of the Food Safety Initiative and HACCP.

The remainder of my comments address priority setting in general. I suggest you ask yourself who you should be attempting to satisfy. We continue to hear that the American public is demanding a safer food supply but the message is not coming from the American public. It is coming from those who make their living selling sensationalism.

The American public does expect you to do everything possible to protect them. They expect you to do what is reasonable. The American public does not want behavior mandated. They want behavior influenced; less regulation, more advice. The most effective public-health efforts that we have seen in our lifetime have been the result of advice and education.

In closing, I will share a story my grandfather told me many years ago. It is similar to the Joe Levitt pebble story. He said there was one a farmer who had a two-horse wagon which he used to harvest corn. The wagon got old and the farmer decided to build a new one.

When his neighbors came over to help, they convinced him to build a much bigger wagon, one that would hold more corn. Together, they built an enormous four-horse wagon. When the wagon was finished, the farmer realized he had to acquire two additional horses and harnesses to use the wagon. When he used the wagon, he found it was difficult to maneuver, too heavy to use in the fields, too big to get into the barn.

The four horses didn't work well together and, in a day, he could only fill one-half of the wagon. He soon realized his ambition had led him to build a wagon that did not meet his needs. My grandfather told me he learned a great lesson from this wagon because he was the farmer that built it.

He built a wagon he wanted, not a wagon he needed. I share this story with you because I find the Food Safety Initiative and your list of activities to be very ambitious. I urge you to acknowledge the activities in which you have an opportunity to excel and which provide the most protection to the largest portion of the American public.

Don't overextend your resources to a point of mediocrity and ineffectiveness and be careful not to be drawn in controversial issues which consume tremendous resources and may only solve small problems. Finally, trust yourself. You know your programs better than anyone else. And don't be afraid to acknowledge your limitations.

Thank you.

MR. LEVITT: Thank you, Bob.

I wonder if I could start with Mr. Corby, if you could elaborate a little more on your vision for a vertically integrated inspection program.

MR. CORBY: I think the two key words are vertical, in that it is top-to-bottom. It begins with the federal government providing the leadership, providing us the science, providing us the standards, evaluating state programs, those that are not believed to be up to standard, to provide the input on how to upgrade those state programs, certification of inspectors that are working and provide the training and uniform inspection procedures, recall procedures and so forth.

In return, the states can provide hundreds of thousands of inspections, hundreds of thousands of investigations of consumer complaints, hundreds of thousands of samples and a database. It is this boulder that we could both push up the hill. That is vertical part of it.

The integrated part of it is simply to combine all the data that is available at the state levels. We have fifty food-safety agencies, at least fifty food-safety agencies, doing their own thing. If we had the leadership of the federal government in this system, we could all be doing the same thing together.

MR. LEVITT: Thank you. To what extent do you think that can be done within existing funding or to what extent do you see that as an area that needs additional funding, either for us or for the states?

MR. CORBY: I would foresee that it would need additional funding. That is the part I really didn't mention, I guess, on the vertical part of. Part of the top-to-bottom would be a funding mechanism or some of the funds available through the federal government would be sent down to the states, in like fashion, like they are doing with cooperative agreements, partnerships and contracts, anyway.

MR. LEVITT: My last question, I'm not sure if it is for you or if it is for Ken. How do you see that relate to the currently existing three cooperative programs that we have in the states of which Shellfish is one? Are they separate or are they part of a more coherent whole?

MR. CORBY: I am not sure I understand your question. Whether that would be abolished, are you saying?

MR. LEVITT: Whether the cooperative programs, the Shellfish Program, the Milk Program, the Retail Program; are they part of this?

MR. CORBY: Yes; they are, because they provide the standards, they provide the guidance and the training. Absolutely.

MR. MOORE: And they also provide the mechanism to do it.

MR. LAKE: Each of you had something to say about fraud, so I am going to follow up on each of you on that a little bit. Mr. Moore, you made an intriguing comment that you thought we ought to focus on those fraud issues that had public implications. I wonder if you could elaborate on that just a little bit.

MR. MOORE: Well, there are situations that when you substitute foods, that there may be people that are sensitive to particular kinds of foods. When substitutions occur, you have people consuming foods that otherwise would not be consuming these particular foods because they have known risks and they are aware of them.

Those are the situations that, certainly, have food safety implications. But when you look at simply issues of fraud in general which may not, at all, have food safety implications, I think in a time of dwindling resources, you have to make some hard decisions.

I think it is unfair to the American consumer that he has to be in a buyer-beware situation but maybe we have to look at that as a reality that, quite frankly, we can't solve with food safety programs.

MR. LAKE: Thank you.

Mr. Corby, you, also, raised something about fraud. You thought, I think, too, or at least I got the impression you thought there might be some areas or some types of practices that, perhaps, ought to get more attention than they are getting.

Could you elaborate on the particular practices?

MR. CORBY: Yes. Our impression is, within NLEA which has preempted the states, although we do some of the inspection work during contract work for FDA, violations that we note on the Nutrifacts Panel and submit into FDA, that little or nothing is being done, or at least we are not being advised that anything is being done.

We are left with the impression that nothing is being done because we continue to see these violations. Then there is the issue of health claims which, actually, we can do something about. But I think the state has been reluctant to do anything with labeling issues. They feel they are in the preemptive box with the nutritional issues and I think they are much less progressive with some of the other issues that we really can do something about.

I think, perhaps, if FDA was as aggressive with NLEA in writing to state governors and recommending that they promulgate NLEA, I think that would help a lot. I don't think a lot of states have promulgated NLEA into their state regulation and if they did, I think you would definitely see an increase of enforcements.

MR. LAKE: Thank you.

MR. SPILLER: Mr. Corby, where FDA has issued a HACCP regulation, seafood, for example, which is in my area so that is what I am most familiar with, under a vertically integrated national effort, would it be your expectation that the states would be the primary inspectors of all domestic seafood processors implementing that regulation?

MR. CORBY: Yes. Of course, with the oversight of FDA. You know, my association, AFDO, talks about uniformity but yet there is not an awful lot of uniformity out there. If we had the guidance and the leadership from the federal government, whether it be certification, as you do have with seafood HACCP, then there shouldn't be any difference between a state inspector or a federal inspector.

The states can do those inspections. Absolutely.

MR. SPILLER: Thank you.

Mr. Moore, you talked early on about sporadic Norwalk outbreaks from overboard discharge. Is there more that the Food and Drug Administration ought to be doing with regard to the overboard discharge situation?

MR. MOORE: Given the last two or three outbreaks, I think the Food and Drug Administration has directed more attention. They have certainly led an investigation in the most recent outbreak.

I think some of the findings are somewhat intriguing and it offers us an opportunity, maybe, to address these things. I think the question was actually are they receiving attention. Yes; they are receiving attention. I was suggesting that, maybe, that these are some of the areas that need to continue to receive attention and maybe we need to find innovative ways to solve them.

DR. TROXELL: Mr. Corby, you talked about CFSAN providing leadership. In a world of imperfect science and policy decisions have to be made, do you have some thoughts on our interaction and how we might execute this together with the states and AFDO in some practical way so we can get to these endpoints? Do you have any particular thoughts?

MR. CORBY: There are a number of issues that we all deal on, I suppose, if we could deal on them jointly. We have a concern, for instance, with a variance mechanism in the Food Code where it requires a variance for curing and smoking of meat products at retail.

AFDO has a guideline program put together. We can't seem to get anybody, particularly USDA, to even look at this. If we could get that thing approved and have the scientific assurance that what is in that guideline is okay, that could be a suitable mechanism for states to comply with that difficult variance requirement in the Food Code.

It has always been a problem, these variances in the Food Code. I would just say there was some mention of, perhaps, a science officer being appointed in CFSAN that could work with the states and could be a central liaison. I think that would be very helpful. I know in AFDO we would probably interact with such a person frequently.

MR. LEVITT: I have one more, and that is you mentioned the Food Code which I think is important, but what priority do you think we collectively should be giving to getting the Food Code adopted by more states and what do you think our target should be?

MR. CORBY: Quite frankly, I think that you have done it all. I think the battle of the Food Code is over with. We went through the battles in the early '90's. That has all been ironed out. That Food Code is a superb document. It has been supported by the Conference for Food Protection, by AFDO, by industry groups.

You have written to governors and I think, perhaps, it is the associations' turn to start doing something. I know AFDO has written to all governors. I think we have to do a little bit more to--again, our motto is uniformity and we should be, I think, doing more to get that promulgated by states, more states.

MR. SPILLER: This is for Ken. You mentioned program evaluation criteria as one of the things that we need to consider doing in the future, at least in the Shellfish Program. I can tell you, as a program manager, that this is one of those things that we keep thinking about that we need to get to and we are always dealing with the crisis of the day, and so it is, "Well, we will get to it," and never quite.

How urgent a priority do you think we should make that?

MR. MOORE: If you look at the role of FDA in the National Shellfish Sanitation, one of your primary roles is the evaluation of state programs to determine compliance with the interim requirements of the program.

If we are going to insure uniformity and we are going to provide the states with assurances that all shellfish that are shipped in interstate commerce are meeting a minimum standard, I think it is important that we at least evaluate these states in a similar manner.

With the downsizing that has occurred, there has been, obviously, a number of different approaches in terms of how your regional offices are prioritizing their workloads. It has resulted in some differences in terms of evaluation.

You can imagine the difficulties that may present when FDA is finding noncompliance in particular areas. I think it is an immediate need. I think the Interstate Shellfish Sanitation Conference can certainly work with FDA. You and I have actually begun to do this with the submission of a particular issue for consideration at this year's annual meeting where we are beginning to define the kinds of things that FDA should be commenting on in the state evaluation.

Quite frankly, in years past, we have looked at this as though it was a cooperative program. We found situations, quite frankly, in which cooperation may not be the best way to describe some of the relationship. I am not blaming either party, but obviously the criteria, when everyone is attempting to be cooperative, is very different than the criteria when parties may choose not to be cooperative.

I think we have to go to that next level and ask ourselves what are the criteria that we are going to use when we are not seeing the kind of cooperation that we initially thought would happen in this program.

We have some of those issues out there that we need to deal with and we need to deal with them immediately.

MR. LEVITT: Any other questions? If not, let me thank both of you for coming and kicking off our meeting in the best possible fashion. I know also both of you needed to travel from out of state to get here, so we very much appreciate your taking the time for doing that.

Thank you very much.

Our second group is a group of food trade associations, the American Frozen Food Institute, the Grocery Manufacturers of America, and the National Fisheries Institute. If we could ask those representatives to please come up. I have listed Bob Garfield, Steve Ziller and Robert Collette.

American Frozen Food Institute

MR. GARFIELD: Thank you, Mr. Levitt. I am Bob Garfield. I am Vice President of Regulatory and Technical Affairs for the American Frozen Food Institute. The American Frozen Food Institute, known as AFFI, appreciates this opportunity to address the agency concerning CFSAN's program priorities.

AFFI is the national trade association representing manufacturers and processors of frozen-food products throughout the United States. AFFI's more than 585 member companies account for over 90 percent of the total annual production of frozen foods in the United States valued at approximately $60 billion.

AFFI members are located throughout the country and are engaged in the manufacturer, processing, transportation, distribution and sale of products nationwide. AFFI members include processors of frozen bakery, dairy, meat and poultry products as well as frozen prepared foods, seafoods, juices, fruits and vegetables.

AFFI applauds CFSAN for its efforts in launching a comprehensive analysis of the system by which it assigns and prioritizes its responsibility. AFFI agrees in principle with CFSAN's work priorities for its regulations program as outlined in the June 3, 1998 Federal Register notice.

As a threshold matter, however, AFFI strongly believes any CFSAN prioritization system, whether for regulations or for other program areas, must be guided by the overall goal of a food safety regulation scheme that is uniform with respect to its objectives, consistent in approach and coordinated in implementation and that most effectively and efficiently utilizes current resources to address risks of public health significance.

To accomplish this objective, CFSAN must conduct a comprehensive analysis of FDA's current food regulatory approach using the following five principles as its guide in assessing and assigning priority.

First, all efforts to reduce risk must be based on scientifically informed and factually based risk assessments. Second, the agency must adopt flexible and responsive regulations that encourage research and innovation. Third, CFSAN must recognize that industry is responsible for the integrity of its products.

Fourth, the agency should seek clear, consistent and performance-based regulations. Finally, it is an imperative that all food handlers in the distribution chain from farm to table be educated on food safety practices.

With these general principles in mind, I would like to share AFFI's thoughts on the specific questions posed by the center in the Federal Register notice. First, CFSAN asks whether there are issues that directly affect consumer safety that are not being adequately addressed. Some commoners may posit areas they believe warrant scrutiny. AFFI believes, however, that the more pertinent question, and the question the center should be asking is this; based on a scientific and fact-based risk assessment, which issues that directly affect consumer safety should be a priority for the agency and which should not.

An example may help illustrate my point. FDA has allocated and will allocate significant resources to a whole host of that which it considers to be important consumer safety initiatives including mandatory HACCP programs for seafood, safety plans for raw and minimally processed vegetables and egg-safety programs.

In addition to these, the agency has a number of other important initiatives which it plans to undertake. Given this ambitious agenda, some issues which the agency currently addresses will have to take a back seat. In this context of limited resources, it is difficult to comprehend why the agency has proposed to mandate HACCP for all juice processors including processors who pasteurize their product.

The reasons cited by the agency for mandating HACCP simply do not rise to the level of high consumer safety priority. Of the sixteen microbiological outbreaks cited, only three were clearly attributed to pasteurized juice. Of those, one was attributed to water or a virus, another to yeast, and a third to an infected worker. None of these would, necessarily, would have been prevented by a HACCP program.

The other justifications offered for a HACCP include tin and metal packaging issues, recalls due to inadvertent addition of ingredients like colors and sulfites, and sanitation and equipment recalls.

My purpose in presenting this litany is not to plead for the pasteurized juice industry although I think the agency has not made a substantive case for requiring mandatory HACCP for pasteurized juice operations but to ask why, given its limited resources and aggressive food-safety agenda, the agency is even contemplating expending valuable resources on an industry that has a safe record and on a problem, if one even exists, that can be handled through current CGMPs, voluntary HACCP programs, and federal and state inspection programs.

I use this example because AFFI strongly believes FDA's food safety resources must be used prudently and, in those circumstances in which a food contains a sensitive ingredient which does not undergo further processing and for which substantial evidence exists that the food may present a significant risk to public health.

Only under these circumstances will FDA be able to address, with its limited resources, those issues which directly affect and are most imperative to insuring consumer safety.

Other than food safety, let me highlight three areas from CFSAN's list of priority activities that AFFI believes warrant high priority for the center; food and color-additive petitions, food standards and Codex activities.

Let me briefly explain why each of these should be considered important activities. Each day, researchers around the country are working towards breakthroughs which will enhance the safety and efficacy of our food supply, permit the introduction of foods which will attract a broader cross-section of consumers such as foods that taste great and contain less fat and cholesterol, and create colors and additives that make food more appealing and, in general, add more diversity and choice to the American consumer.

In many ways, this is no different from the innovation constantly taking place in all segments of the American economy with one important exception. Innovation within the food industry is slowed by the regulatory process. To address this, CFSAN must work to streamline the approval process.

AFFI respectfully suggests that the center must strive to use internal resources more efficiently or look to alternate extra-agency resources to move the food and additive color petition process into high gear.

I also mentioned food standards. AFFI believes that it is appropriate, as FDA proceeds through its modernization process, that the food industry have the opportunity to do the same. Food standards were established many years ago as a means of assuring consumers that what they saw on the label was, in fact, what they got in the package.

Today, as a result of the Nutrition Labeling and Education Act and other laws and regulations, consumers have the tools they need to understand the contents of the food product. Yet food standards that remain on the books in many instances hinder innovation.

FDA should allocate resources with industry to explore this area, not necessarily to expunge all food standards but to determine the instances in which standards are inhibiting progress and can be modified to increase innovation.

Lastly, let me address Codex and international activities in general. AFFI, through its international organization, the International Frozen Food Association, represents the frozen-food industry on a number of Codex committees as well as the Codex Alimentarius Commission.

IFFA has also been active with other international bodies which deal tangentially with food issues such as the Intergovernmental Forum for Chemical Safety which addresses chemicals including food additives and pesticides.

From AFFI's perspective, the U.S. is quite frankly being routed in international activities by voting blocks such as the European Union and now the Mercusor countries which are able to use their members to project an impression of consensus during committee meetings.

Because a vote on issues is rarely taken, vocal delegates can usually prevail in these fora. Given the importance of Codex and international standards in general, the U.S. simply cannot afford to take a back seat to anyone. The U.S. must exercise leadership in Codex and FDA must play an important role in that effort.

With leadership in mind, I offer a few recommendations to strengthen the U.S. role. First of all, U.S. delegates to Codex must be effective and informed leaders who are well-trained in presentation skills. Second, U.S. delegates should be trained in the art of diplomacy.

Third, the U.S. Department of State should be represented in all U.S. delegations to Codex and the State Department representatives should be an active component of all delegations' activities. Finally, the U.S. should expend more resources to host Codex committees for which it has responsibilities.

Without a comprehensive and consistent international system of food ingredients, food standards and food safety practices that is shaped by the U.S. input, the U.S. jeopardizes both the safety of its consumers and a tremendous economic opportunity available to U.S. business in this globalized economy.

CFSAN must also ask what the highest priorities should be for the center's research resources to insure that all agency initiatives are premised on risk assessments that are scientifically sound and factually based. AFFI urges the center to make the development and application of methods to quantify exposure and risk the primary thrust of its research activities.

The importance of this research to the overall goal of building a more uniform consistent regulatory scheme for foods cannot be overstated.

Thank you for the opportunity to share AFFI's view of CFSAN's prioritization. AFFI plans to submit written comments on this important initiative in the near future.

MR. LEVITT: Thank you very much. It sounds like will be getting some comments on the juice HACCP from you, also.

Next, Dr. Ziller from GMA.

Grocery Manufacturers of America

DR. ZILLER: Thank you, Mr. Levitt. I am Steve Ziller, the Vice President for Scientific and Regulatory Affairs for the Grocery Manufacturers of America. We want to thank FDA for the opportunity to present these oral comments at this public meeting addressing the prioritization of programs within the Center for Food Safety and Applied Nutrition.

As you know, GMA is the world's largest association of food, beverage and consumer-brand companies. With U.S. sales of more than $430 billion, GMA members employ more than 2.5 million workers in all fifty states.

Our answers to the questions you have posed in the June 3 Federal Register announcement are based on input from our member companies. We asked our Technical Regulatory Affairs Committee to address the details on FDA priorities. This committee is composed of the top quality-assurance and regulatory managers within our member companies.

They collectively have hundreds of man years of experience working both the business interest and the interactions with FDA from a regulatory perspective. Thus, they are uniquely qualified to provide the most relevant input in your prioritization process.

We will submit a full written report but let me summarize some of the key points in our assessment here. GMA is acutely aware of the extensive responsibilities Congress and the President have assigned to FDA. Every effort should be made to work cooperatively, efficiently and effectively with other government bodies so that the greatest collective bang for the buck can be achieve.

This includes cooperation with the states on compliance issues and with USDA, EPA and CDC on issues of mutual interest and responsibility. It is also very important to increase cooperative efforts with the food industry to address key food-safety and regulatory issues.

In the final analysis, the food industry, though, is primarily responsible for the safety of its food products. GMA wishes to draw special attention to six key points which stand out for special consideration in prioritization.

One; major decisions on prioritization of food safety issues should be based on sound science and risk assessment. Higher priorities should be given for the most important food safety risk and lower priorities for the lower risk or negligible risk.

Two; greater research efforts should be focussed on emerging food-borne pathogens, quantitative risk assessment, practical detection methods--for example, cyclospora--faster analysis and identification of sources and the means of prevention of contamination in foods with pathogens.

Three; greater and more effective food safety educational efforts for food preparers and food service retail in the home should be undertaken. Those efforts should include alternative approaches to insuring food safety including use of new technologies such as irradiation.

Four; health contributions for the diet in maintaining health and preventing disease is as important as classic food safety. Therefore, health consideration should have a parallel prioritization as food safety. The healthful contributions of conventional foods, functional foods and dietary supplements will make it increasingly important for FDA to provide the appropriate regulatory environment to support and yet oversee.

Five; the international scope of the food supply is a reality today. Efforts must be made to harmonize the regulation of this global food supply for the benefit of consumer health and safety as well as the facilitation of U.S. food trade. A clear shorter-term focus would be harmonization across the NAFTA countries, Canada and Mexico.

Six; FDA should also consider to carry out other important functions that are less directly linked to food safety--for example, the modernization of the food standards in the United States--and also exercise an enforcement presence where there is egregious economic fraud such as in the adulteration of high-value juices.

Let me elaborate briefly on each of these points. The first point is somewhat self-evident; expend resources on the highest priorities first. However, history has shown it frequently is forgotten in practice. An ex-general counsel at FDA has confessed that a great deal of FDA resources and time went into chasing very low chemical risk for many years, almost to the exclusion of those microbiological risks that the scientific community knew were the highest priority.

FDA must set in place prioritization processes and criteria for resource expenditures which will avoid this as far as possible in this time of high budgetary restraints for the agency in the foods area. History should not be repeated.

With respect to research, FDA has made the commitment to be a leader in the important effort to develop better quantitative risk assessments, particularly in the area of pathogens. However, this is an area which has drawn attention and funded studies by many excellent scientific groups in government, industry and academia.

It will be most important to work cooperatively in developing strategic approaches to avoid duplication of efforts and to achieve the maximum new information which will aid FDA and the industry in providing safer foods to consumers. Thus, while this is a high-priority area, there may be need to assess where science gaps can be filled outside of FDA itself with FDA using the results of all this research collectively to develop better science-based regulatory policies.

Certainly, better methods of analysis and means to prevent pathogens from entering the food chain deserve the highest attention. Educational efforts on safe food preparation and handling should be a high priority. Spearheaded and supported by FDA, these are particularly good investments based on the magnitude and pattern of the current incidences of food-borne illness.

FDA has an opportunity to provide the benefit of their scientific and regulatory expertise and experience. FDA and its parent organization, HHS, are in an excellent position to be a full partner in educational coalitions with other government agencies, the food industry and other consumer scientific and educational organizations.

While other efforts should attempt to minimize introduction of contaminants as far up the food chain as possible, a strong educational effort like Fight Back can give major assurance that consumers and other food handlers will know how to best protect the food supply from inadvertent contamination.

In the current criteria, health is significantly reduced in priority compared to food safety. We believe that this traditional view is outmoded today. Health and safety should be the same priority. This is justified because of the burden of healthcare costs and the general consensus that prevention and maintenance of good health, perhaps optimum health, should be a high national priority.

Because of this, we recommend the first criteria be changed to the highest priority will be those regulations that enhance consumer health and safety. Within this criteria, we would include speeding up application reviews for GRAS ingredients, new food additives and extension of existing approvals, threshold of regulation determinants and nutrition content and health-claims petitions.

With the advent worldwide of functional foods, it will be important to make necessary adjustments in the current regulatory system for claims to avoid needless barriers while still maintaining appropriate regulatory oversight. Failure to address these areas in a timely fashion constrains manufacturers' abilities to incorporate new and improved technologies in their processing lines

In many cases, it also prevents companies from delivering the nutritionally improved products consumers are demanding and from communicating effectively with consumers. The international program area is one that deserves a high priority also with special emphasis on Codex Alimentarius standards and guidelines which serve to protect human health and facilitate trade.

Given the role imported foods play in the U.S. food supply and the interest of U.S. food producers in expanding exports, GMA strongly urges CFSAN to devote an increased amount of resources to Codex activities, particularly in the area of establishing standards and guidelines for food hygiene and safety, guidelines for import and export inspection and certification systems, general standards for food additives and contaminants, harmonization of flavor regulations worldwide, labeling of foods developed with biotechnology and harmonization of health and nutrition claims.

Of course, there is an underlying need with respect to Codex. Codex has a committee which, in essence, is like the Rules Committee. It is called the Codex Committee on General Principles. This is another area where, if you lose an important factor there, it undermines all the work you do in these other groups. So that would be another area to add.

These are areas where FDA has been involved in the past, but more effort is required to maintain U.S. leadership on key issues. There is need to assure that the necessary prework for Codex committee meetings is completed on a timely basis with appropriate participation by the industry so that U.S. positions can be decided and shared with other company delegates who will be participating in the respective Codex committee meetings.

Our recommendation is to add another criteria at the level of the previous No. 3 which would state, "CFSAN participation in and commitment to establishing an equivalent, consistent and efficient global regulatory system for food and food ingredients."

A subset to the previous international priority is emphasis, in the short term, to harmonization of food regulations between NAFTA trading partners, Canada and Mexico. Different systems of regulations in place today unnecessarily constrain cross-border operations. Many products cannot be shipped across the border without reformulation and preparation of different labels.

FDA should take greater initiative in seeking to harmonize or recognize equivalent food regulatory systems.

A final category of priorities is composed of programs which are not directly related to food safety but represent an important priority to the food industry and consumers. An example of this category is continuation of the process first started in reinventing government to modernize the food standards through simplification.

Another example is maintenance of a visible compliance program where egregious violations of economic fraud occur such as intentional adulteration of juice products. Without a visible and effective presence in this area, GMA fears that a few bad actors, wholly unrepresentative of the mainstream food industry will victimize consumers and, in doing so, shake public confidence in the food supply.

In addition, the reputable food industry will be disadvantaged in the marketplace for complying with the laws and regulations.

In closing, GMA welcomes FDA's process to address prioritization. We hope our comments are helpful at this time and we look forward to working with FDA in the future as you make decisions on prioritization and implement specific work programs.

MR. LEVITT: Thank you very much.

Next is the National Fisheries Institute, Robert Collette.

National Fisheries Institute

MR. COLLETTE: Thank you. My name is Robert Collette and I am the Director of Food Regulatory Affairs for the National Fisheries Institute. NFI is the largest trade association for the fish and seafood industry in the U.S. Our 1,000 member companies are involved in aquaculture, fishing, processing, distributing, importing and/or exporting of fishery products.

NFI commends CFSAN for its plans to develop a comprehensive program to address food safety issues in the context of emerging food technology and changing food processing and distributions systems. We also thank you for this opportunity to provide you with our comments and suggestions.

You have posed six questions. The first question is whether there are issues that directly affect consumer safety that are not adequately addressed in CFSAN's program. The FDA has done a good service to consumers in adopting its mandatory HACCP inspection program for fish and seafood. Your new inspection program under the guidance of the Office of Seafood is proactive and it has focussed the energies of the industry and the FDA on food safety concerns.

It has also provided an opportunity for closer cooperation between our industry and the agency. The present program, however, is not fully comprehensive. Most firms handling fish products are covered and almost all fish reaching consumers passes through the HACCP system.

While fishing vessels, which do not process their catch, are exempted, the processors who receive their fish are covered. The requirement that all processors operate under HACCP systems insures that most fish pass through hazard controls before being sold to consumers.

There are some fishing-vessel operators, however, who sell direct to consumers; retain food stores and/or restaurants. While the amount of fish sold in this way is small, vessel operators who sell direct to food-service or retail operators or to consumers should be covered by the HACCP regulation.

We believe FDA should evaluate the food safety risks associated with this potential loophole and expand HACCP coverage as necessary.

You also asked about programmatic priorities. NFI believes research and education are essential and need to be undertaken in cooperation with academia and industry. An excellent example of how research and educational needs can be identified is the Fish and Fishery Products Hazards and Controls Guides developed by FDA to help its inspectors and industry implement the new seafood program.

The guide represents a tremendous undertaking and has proven useful for identifying potential hazards and options for their control. The informal process used by FDA to develop and revise this guide is a very good way to identify where further research or educational efforts are needed.

In our review of the guide, for example, we have identified several instances where research is needed to reach a better understanding of risks and controls and to fill in data gaps. In this regard, FDA needs to continue working with the industry and the academic community to identify and address areas requiring further investigation and/or study.

Your notice for this meeting suggested that your highest research priorities relate to methods development. Risk assessment is identified as a secondary category of research. Given the existing data gaps associated with the significance and control of food safety hazards, research on food risk assessment should be given equal weight and conducted in careful coordination with your research of methods development.

Training and education projects should also have a high priority. When preparing for the mandatory seafood HACCP inspection program, FDA worked closely with the seafood-HACCP alliance to develop a uniform curriculum to train industry personnel and FDA investigators in the principles of HACCP and their application to fish and seafood processing.

Once that curriculum was completed, industry, FDA and state inspection personnel attended training workshops together. I emphasize "together." The effort was very successful because of the participation of FDA in both the curriculum development and workshops. This effort should be a model for future FDA cooperation with academia and industry.

It would be a serious mistake to think that further seafood training is not needed, or training in other areas of the food industry. Our experience so far suggests that the present training program should be strengthened, in particular with fish and seafood, in the areas of sanitation control and verification procedures.

Educational programs at the consumer level must also be a priority. In recent years, consumers have received confusing and sometimes conflicting information about food safety. FDA's leadership is needed in defining what the true risks are and to help consumers understand what they can do to minimize exposure to them.

Special emphasis should be placed on reaching children and young adults and those persons who are most at risk.

Your notice also raises a question about FDA's role in Codex Alimentarius. Much of the U.S. food supply is imported. The U.S. is also a major food exporting country. This is particularly true for fish and seafood products. The market for fish and seafood is global. Codex quality and safety standards are being utilized increasingly to resolve food safety disputes between nations in the World Trade Organization.

Therefore, FDA must play an active role in Codex to insure international standards and guidelines are consistent with U.S. requirements. For example, Codex is presently combining all its codes of practice for fishery products into a single comprehensive code and, in the process, is revising the code to include HACCP principles.

Given the importance placed on HACCP systems to control the safety of our food supply and the need for consistency in defining and applying HACCP principles, the FDA must help shape the new Fishery Code.

More importantly, the FDA must move aggressively in the next few months to negotiate effective international agreements for seafood inspection with nations which are producing much of the seafood Americans eat. FDA's seafood HACCP regulation covers both domestic and foreign processors. At the present time, FDA verifies foreign processor compliance by periodically testing entries and by examining U.S. importer documents describing how U.S. buyers have verified that their suppliers are obeying FDA's rules.

However, regulatory verification activities are most effective when they are conducted on site by competent inspectors. Therefore, FDA should negotiate agreements with government agencies possessing the proper authority, training and resources to conduct on-site HACCP inspection. Several countries want to enter into such agreements with FDA. Unfortunately, not a single mutual recognition agreement has yet been signed. This must change.

In short, put the other governments to work for you. The last question posed in the notice for this meeting dealt with economic fraud. FDA shares the responsibility with industry in assuring that consumers get what they have paid for. Therefore, the agency should not diminish its oversight of economic violations.

This oversight, in our view, can be best strengthened with better technology. For example, hundreds of different fish and seafood products are in the marketplace. This vast array of products provides consumers with a great variety of choices but it also creates the potential for mislabeling problems due to the complexity of fishery nomenclature.

FDA has addressed this problem in part by developing the Seafood List, a guidance document containing scientific, common and market names of fish and seafood. The Seafood List is great. However, FDA must have accurate methods to verify it is being followed. Presently, there is no proven method for identifying fishery products which have been heat-processed such as cooked crab meat.

For enforcement of label accuracy, FDA needs methods which identify the products which have been packaged. Again, for CFSAN, research is the answer.

This concludes NFI's oral comments. We plan to submit additional written comments by the July 15 deadline. Thank you again for the opportunity to provide comments on CFSAN's program.

MR. LEVITT: Thank you. As we move into the questions, I have got a few and then, again, we will move down the table here. I think my first would be for Steve Ziller, and all the others who are willing to comment, also. I was impressed with the number or priorities you thought we should have. I looked through our several-page list and I think I found maybe one thing that wasn't grouped under your six categories.

If you could identify, say, three boulders that, a year from now, would be up and over the hill, concrete things to do and get done, could you come up with a few?

DR. ZILLER: Some of the key issues that I identified are what we believe are sort of major trends in the industry and in the international activities. I think that there are subparts of that that have components that can be accomplished in the time frame that you are talking about.

But I think what is needed is to really decide how you are going to deal with the sort of overarching major issues and then subdivide that so that you can parcel out, in a given year, what resources you have available to given pieces.

Certainly, the international piece is very important and growing, and there are some time frames there on renegotiation of major international trade agreements, and there are time frames of the major decisions of Codex that occur every two years at commission meetings. So there is a certain sort of bundling of important issues that have to get done in a certain time frame or you miss a window by two years which, for some of these trends, is a long time.

But, certainly, there are important things. In the area of Codex, for example, the issues of finalization of standards at Step 8 and those that have a chance to get there can be portioned out and focus put against those issues.

Certainly, the meeting in September of the Codex General Principles meeting where they are going to decide what are the rules under which we are going to go by, are we going to base all of our technical and scientific decisions across all the important committees primarily on science or are we going to allow other things like cultural differences and so forth to be major aspects in the development of these standards which, up until this point, the industry, worldwide, really, and the U.S. government has been strongly against.

We think that is the correct position, but there is a lot of work to be done there, not just to reevaluate what our position is today but to get alignment with some of the other governments who go to these meetings who have to be with you or you will outvoted.

The General Principles meeting is being held in Paris. You can see all of the European countries and their close allies in the developing economic Eastern Europe regions are going to be in one position, in all likelihood, on that matter and we have to find other countries.

There is a lot of work that has to be done. But that is a boulder and we need to get the jacks out right away.

MR. LEVITT: Thank you.

Anybody else want to try to take a crack at some concrete things a year from now we would like to see done?

MR. GARFIELD: I would agree with what Steve said. I think we need to focus on the international activities and we need to have better training of the people that we are sending into these areas. They need to understand diplomacy. They need to have the help of the State Department.

I am sometimes appalled by the fact that there is no one from the State Department that goes along with delegations to advise them on international diplomacy and issues like that. It is just unheard of. My wife works for the FCC and, when they go on an international delegation, the State Department is there in force and they advise the FCC and others on issues.

They are very, very helpful in getting the FCC to understand the international implications of what is going on. I see that as something that is missing in our delegations that go on to the Codex Alimentarius, General Principles and down through to the committees, themselves.

MR. LEVITT: Thank you. Clearly, it sounds like Codex is a major thing and you feel that the general principles, at least in terms of timeliness, is the most important short-term thing. Did I hear correctly that, after General Principles, you would probably list General Hygiene as the next most significant, or did I not hear that right?

MR. GARFIELD: I didn't say that. Certainly, from the point of view of things directly related like pathogens, food imports, and so forth, I think it is a critical committee but I think it is a critical committee. But I think there are some other issues that I mentioned in my oral comments that relate to food additives and contaminants.

The United States has done an excellent job, for example, on things like heavy metals and some other kinds of contaminants in foods that is not the case in some other countries. And the Codex is a way, not only to try to get some harmonized standards, but it is also a good process that kind of helps educate other countries on what the key issues are that maybe they ought to be focussing on, also, which will have a good impact in terms of the quality of worldwide food trade.

So, certainly, the food additives and contaminants standards are being worked on. And then the Australian committee that doesn't meet until after the first of the year has to do with the whole import-export certification system and so forth. And that is kind of linked into many other things that Food and Drug is looking into at the present time.

So I think there are some critical elements. Many of these things are not necessarily that much added work because they are focal areas that also apply to concerns within the United States. So it is not so much totally an addition to domestic work. It is reapplication of some of the science and the regulatory thinking that has already gone.

Our position is that we think that the U.S., in many of these issues, is in a place to play a leadership role because they have access to a tremendous amount of good science. What has been missing is the translation of this and the communication. We think that government-to-government is a good thing to strengthen in those respects, but we also think that the industry can be helpful because we have connections, we have multinational companies who are in a lot of other countries.

We can help from sort of the ground up in some of these other foreign countries develop education and knowledge of these issues so that their governments are willing to take a stand in alignment with the U.S. position.

MR. LEVITT: Thank you. Believe it or not, my second, even though it sounds like I already had my three, has to do with application review. A number of you have focussed on food additives and other priorities. One thing that surprised me when I came into CFSAN was that application review extends beyond food additives and color additives.

If you think that you have to come to the FDA before something happens, and we have listed a number of them in there, but that we have, in addition to food and color additives, GRAS determinations, threshold and regulation determinations, product notifications, consultations with biotechnology firms and what I will call the food additive stuff, in addition, you have got the notification program for infant formula, the notification program for dietary supplements, the new thing on the FDAMA, the notification for nutrient content and health claims.

I know, Steve, you wanted to give equal emphasis to those kinds of things as well as the traditional petitions, or more traditional, on health claims. Is there any way to prioritize among that mass?

DR. ZILLER: There is but it is very difficult. The industry would likely have the same difficulty that you would have because we have some members who, if they have a given invention or food additive or a health claim that they are interested in making, obviously, they think that is the number one priority for them.

So you have the problem of how do you collectively look at those in some rational way and decide which ones you bring forth first and so forth. There is a variety of alternative ways you can look at that in terms of--the old way was kind of first-in, first-out, but there was little coming out.

I think Alan Rulis has done an excellent job under the resource restraints that he has had to move that system in a very positive direction and I think, to a great extent, it is resource-limited. But I also think that there are still some attitudinal and management issues that still need to be worked through to make such a system more efficient.

But, certainly, things that impact more directly and would be recognized in the scientific community as being more useful in terms of more helpful diets as opposed to other things for which there is less justification on that basis.

There is a variety of ways that could be looked at to sort out which ones of those things should happen. I think, in some cases--for example, I have heard some people who are very knowledgeable about the details of things around the indirect-additive area. I think that they think that there are a lot of those things that probably could be looked at responsibly but with less resource and intensive time demands than things have in the past simply because there is so much experience, now, with handling those that I think knowledgeable people reviewing those things could do them more quickly.

There are other countries that do a reasonably responsible job that use less resources per 25 of those that they get than FDA currently does. So that gets back to your criteria that has to do with things related to greater efficiency of operation.

MR. GARFIELD: If I might ask you what your thoughts are on extra-agency resources to help move this along.

MR. LEVITT: I would love to try to answer those questions, but I think our ground rules are that if you start getting me talking, you won't get a lot of listening done.

The last question has to do with food standards. Food standards got mentioned a couple of times. If you go back to my kind of question I closed with in opening in terms of what is the benefit to consumer, what is the case for food standards in terms of consumer benefit.

MR. GARFIELD: I think there are a number of food standards out there that inhibit what companies can do, what products they can manufacture and have out there in the marketplace. One that comes to mind in the frozen area is frozen pizzas, for example. With frozen pizzas, frozen pizza manufacturers are restricted by what can be called a frozen pizza just by standards of identity.

This isn't an FDA standard, it is an FSIS standard. But they are restricted in that respect because they can't match what the Pizza Huts and others are putting on pizza and calling them pizzas. So whatever can be done to sort of alleviate that and create a level playing field and allow those products to be put out there in the frozen aisle just as they are being served in restaurants would be helpful and give consumers more choice.

MR. LEVITT: Thank you very much.

I apologize to the Fisheries representative. I will defer to Mr. Spiller. Bob Lake, please.

MR. LAKE: Let me have a question for Bob Garfield as follow-on on the food standards. I was intrigued. I thought, as you were talking about food standards, you mentioned the possibility that there are some that we could simply do away with. Could you sort of tell us what those might be? Are you willing to put any on the table?

MR. GARFIELD: I don't know if I exactly said that. I would have to get my notes out. But I said not necessarily that we would do away with them but that they may be changed in ways that makes them more flexible. So I don't know that there is anything that comes to mind that we would do away with right off the top of my head. There may be after consultation with people.

I know that, in talking with some people from industry, they would like to test the waters out there and see what happens by giving a test case and see what happens with that, and then, from beyond that, there might be industry interest in either doing away or amending the current food standards.

MR. LAKE: Just one other follow up on that. Again, in terms of modifying food standards, what would you see as the relative priority of putting resources into that activity as opposed to some of the other things you were talking about?

MR. GARFIELD: Our members think it is a fairly strong priority. But the problem is, there was supposed to be some guidance given on how to do that. And we still haven't seen that guidance. So everyone is sort of sitting back and waiting to get the guidance from the agency so that they can move ahead and decide how much and how big a priority this should be based on the guidance they get from the agency.

Now, I do understand recently that there have been some resources that will be put back into that effort so that guidance can come out, finally, and then industry can react to it and see just how big of a priority this actually will be based on the guidance that is given them, how you have got to go about it to amend or do away with a food standard.

MR. LAKE: Thank you.

MR. SPILLER: Mr. Collette, you have been passed off to me so I will take advantage of the opportunity. You said something that was really intriguing about the need for further training in the seafood area. You mentioned sanitation control and verification procedures. Verification is something that I have been thinking a lot about lately.

I think it is going to be one of the next contentious areas of HACCP in terms of trying to figure out what constitutes adequate verification, both of the entire system and on an individual processor-by-processor basis.

Do you feel comfortable--does NFI feel comfortable that it understands what verification ought to consist of now so that the next priority should be to develop training on that? Or do you think that the next priority should be to develop more of a consensus and an understanding as to what ought to constitute proper verification?

MR. COLLETTE: Verification of the seven principles of HACCP, for many people, is the most difficult to fully grasp and understand. I think that, through the training that the industry went through and FDA regulators went through provided by the seafood-HACCP alliance, there was a baseline developed there in terms of a general understanding of verification procedures.

So I think that there is a general recognition of what verification is, but, really, the devil is in the details, I think, with verification. So, to answer your question, I think that probably from the experience that FDA is having currently, right now, in auditing programs and doing its own regulatory verification, it would probably be beneficial for the agency to get together with the industry and, perhaps, again, seeking the help of the academic community, to further define what is adequate verification in various types of operations.

It is not going to be the same across the board for every type of food processing operation and that is even true within the seafood industry. So I think the first step is to further define and characterize that. And then, I think, once we can come to some consensus, which I am optimistic we can, then, perhaps, we can look at whether further training and educational efforts are needed.

MR. SPILLER: Thank you. One more quick question for you. You talked about vessels that sell to consumers and restaurants and so they are bypassing the current HACCP system because they are not selling to processors which are covered by the program.

Is it a foregone conclusion from NFI's standpoint that the vessels should simply be incorporated within the group or should it be a higher priority--and you mentioned evaluation of the risk posed by this situation. Would that be the first priority to evaluate the risk and that is what should be done or is it already a foregone conclusion from your standpoint that they just should be brought in and would that be a priority for you?

MR. COLLETTE: First of all, again, we know that the amount of product that we are talking about here is very small, in the broad range of the entire commercial supply. I think the answer is that we need to further look at that particular situation and judge to what extent, exactly, it is occurring and to really do a risk assessment to determine whether or not these types of operations do represent any potential or significant health risks.

I would say if I were to try to answer the question of how much of a risk does this represent right now I would say very small because of the small volume, number one, and, secondly, most of these operations are handling fish species that pose little threat of chemical microbiological or physical hazards.

But there may be some exceptions. And I think that is where we need to do a further evaluation. As far as the broad scope of fishing vessels being covered, we don't think that that is necessary at this time, although I think we would look to FDA for guidance and leadership on vessel practices perhaps consistent with Codex.

MR. SPILLER: Thank you. Just one quick observation for Mr. Garfield. You mentioned a couple of times the importance of training of Codex, the U.S. delegates to the Fish and Fishery Products Committee. We are just back from that committee. I still have that very much on my mind and I can just advise you that training of delegates has become a high priority for the U.S. Codex Office of the Department of Agriculture.

I am cheering them on in that regard. No one has ever yet accused me of being adequately trained in diplomacy so I am looking forward to it.

DR. TROXELL: I want to make sure we understand what we are talking about here. Both Dr. Ziller and Mr. Garfield advocated sound science and risk assessment to underpin our decisions. I would like to understand what you mean, what kind of risk assessment you mean, and considering that, in many of the problems that we face, the science is incomplete, imperfect and the risk assessment is far from being able to be quantitative.

How shall we be reacting in that situation and set our priorities. For example, in the cyclosporine situation, there are tremendous gaps in the science yet we need to take some protective measures.

MR. GARFIELD: I tried to talk about sound science and risk assessment and put that into the context of the juice proposal. I know it is rulemaking now and you can't discuss that but, to me, it seemed like the case was not really made. It almost seemed, as a industry person--and if I could take another example that isn't under rulemaking--it is almost like you had a problem with alfalfa sprouts and you decided to require HACCP for canned beans because of the problem with alfalfa sprouts.

There just wasn't a connection with the risk assessment that you did on raw juices and the fact that you equated that over to what was going on in the pasteurized juice industry. I think until you make that connection, until you are able to, or you come out with rules that make that connection, I think that industry is going to have doubts about the purpose behind proposing rules.

There are a lot of questions out there as to why you are going about this. Is it because of the sound science and you have done an adequate risk assessment or is it just to implement HACCP? There is a lot of uncertainty out there. If it is the latter, then it should be called the latter. If it is the former, then it should be done soundly.

It seems like that is not being done currently. I know you brought Bob Buchanan on board. I know he is an expert in risk assessment and models and risk assessment and I hope that he would be able to develop some things the agency can use to quantify the risk posed by different situations.

But, right now, I don't think it is being done and I don't think the agency is doing a service to itself when it comes out with a regulation that seems disconnected or a proposal that seems disconnected.

MR. SPILLER: My reference to use of quantitative risk assessment was more in terms of helping assess priorities on what things need to be worked on. But I certainly think there are a number of excellent examples of places where the United States has used sound science and good assessment of risk, and one of them is the one that Dr. Troxell, himself, has used in terms of aflatoxin at the Codex Contaminant meeting, and so forth, in terms of what is the appropriate level, not just in the United States, but internationally where you have problems in terms of just the climate is such that it is virtually impossible to get levels that countries who don't grow certain types of crops are able to set because they have no local constituent who would demand a higher level, so to speak.

And in those arguments I think that the United States government has made at those meetings, they have been very firmly based on that. I think other areas where questions are raised about safety of certain ingredients or contaminants in the United States, I think while the full quantitative risk assessment may not be able to be made at the time, there is at least some sort of semi-quantitative or some reasonable best guesses on the data that may be incomplete but is available that you can use to sort whether it should pour tremendous FDA resources against a given question that has been raised publicly or not.

And I think it will help sort, to a certain extent, those things that demand a significant effort and those things that demand a careful and continuing look.

DR. TROXELL: I actually would like to explore the idea of the scope of use of HACCP. Earlier Mr. Corby suggested the universalized HACCP. Also both of you, Dr. Ziller and Mr. Garfield, advocated--all three of you, actually, advocated that we work towards international harmonization.

I would like to understand how you view the limitation of use of HACCP to just in those severe cases, how would that square with trying to develop international harmonization. If we don't have something that is more universal in preventive controls, we will end up with a hodge-podge, maybe, of GMPs and other controls, how can we demonstrate to our foreign trading partners that we have a system of protections equal to theirs especially when many of the countries in Europe are looking towards HACCP as the standard?

So how, basically, is the go-slow on HACCP going to get you your goal of we should put more priority on international harmonization?

MR. GARFIELD: I think just because you don't have HACCP as a mandated regulatory program doesn't mean it exists. We did a survey four or five years ago of our companies and found out that approximately 80Êpercent of them had either started their HACCP program or had it fully implemented already.

I think it is a foregone conclusion that companies have implemented HACCP to a great extent. They don't need to be prodded into that. Some may. There may be a few that may, but I think, for the majority of them, they know that this is a good system and they are going to put it into effect.

As far as international trade, they can utilize--I mean, there can be ways other than a government-mandated program that they can convince another international government, if they are importing product into that country, that they have an adequate HACCP system.

We have members who import into Japan and other countries. And they regularly are visited by officials from Japan, from other places, to inspect the plants and look at what they are doing in there. These are just mutually agreed inspections based on the fact that they are doing business with this country.

They don't have a problem with it and it works rather well. There is no need for a mandated system under those circumstances. The people they are dealing with come in and look at their facility and see that it is fine.

So I don't know that you need mandatory HACCP to convince any government overseas that, in fact, a U.S. company has a good system.

DR. ZILLER: I agree with Bob. I think most of the sort of international discussions use terms like "based on HACCP principles," and phrases of that nature. I think that, for the most part, at least most of the responsible traders in agricultural products and foods follow those HACCP principles.

I think that there is a difference and that sort of what we would call, in the industry, regulatory HACCP which has that added extra compliance factors some of which, I think, are still really being worked out because, from what I hear, and I am not close to the fisheries business, but I heard some numbers at the IFT meeting earlier in the week where people were bandying about what the percentage compliance of plants was based on the inspections in that area so far with respect to the seafood HACCP, and so forth.

Of course, the impression which was attempted to be given was that somehow that things were unsafe and things are not well in the industry and so forth. My bet is that if one looks at the details, one would find that, in fact, what it is is there are some record-keeping, paperwork, other types of things which are important, but those are the kinds of things that add significant burdens to the industry and to the government inspectors to look at.

I think until we see that we are coming to kind of a steady state in terms of implementation of regulatory HACCP and FDA on the seafood side, and on the meat and poultry in the USDA side, which I don't think that either one is at a steady state quite yet--it is still in the start-up phases in terms of how it is really going to be able to work in a streamlined fashion effectively, and cost effectively, over the long haul.

So that is really kind of what you are feeling a push-back on. In terms of working on HACCP principles, I think most of the industry and their associated suppliers, because of their own high expectations worldwide, I think are not that far away.

MR. COLLETTE: My perspective is not as broad-based as Bob's and Steve's, but with respect to seafood, particularly as you raise the question in the international context, I guess I have something of a bias.

I think the United States, FDA, has done a good job in structuring the HACCP seafood program. I think it correctly targets food safety hazards as the fundamental and central issue in doing a hazard analysis and developing HACCP control programs.

You can get into long debates with most people who are familiar with HACCP in talking about its application to foods over the issue of should it focus solely on food safety or can it, or should it, be used for other essential quality factors, sanitation issues, et cetera.

As I said, I believe FDA has appropriately targeted it to food safety matters. With respect to events at Codex, we know that there are some countries around the world who would prefer to see HACCP based, meaning when you talk about HACCP-based, generally, you are talking about going a little beyond food safety hazards being your focus and entering into not only food safety hazards but issues of sanitation and essential quality in some cases.

So we are six months into the implementation of a mandatory seafood inspection program and we are learning to live with it. We have to grow into the program. It is fairly complicated enough and it represents enough of a paradigm shift for the industry that we feel you have to learn to walk before you run.

Our concern is that there are some in the international community who would have us running before we know how to walk.

DR. TROXELL: I believe Dr. Ziller talked about filling some of the science gaps from outside of FDA. Obviously, the job we have to cover the food supply is enormous in many different avenues. And, of course, one of those aspects is to develop the science to underpin the decisions, and so on.

So I was just wondering what your thoughts are on the partnering and the role of industry either directly to do some of that research or to fund it through academia, and how could this fit in with our overall prioritization and allocation of our resources here.

DR. ZILLER: I think there are some excellent models that have worked well. Some of them, perhaps, could work better with some additional attention. I think, certainly, the forum of ILSI, both in the United States and worldwide in the various bodies they have in Europe and in Asia and so forth around the world has proven to be an excellent umbrella under which to gather with industry, government and academic research scientists to work on issues.

I know FDA, USDA and a variety of regulatory agencies have funded research there jointly or separately and found that the results have been very useful as underpinning for regulatory decisions.

There are some other areas that I think have shown limited success and have promise for the future. Certainly, the Center for Food Science and Technology in Chicago that the FDA is a partner in is one of those, and then the sort of emerging GFSAN operation will be another opportunity for government and industry to work on problems of food safety where they can jointly run research projects that they think are in their mutual interest.

So I think there are a number of those from the past some of which may be able to use some revitalization. I think they are in the process of looking for a new director of GFSAN, now, and when they get that person on board, I think they will be able to move forward with that.

And I think some of the objectives that I have heard relate to some of the things that we were talking about this morning in terms of quantitative assessment and so forth. So I think there are fora and I think that the industry will be willing to cooperate as they have in the past.

MR. LEVITT: With that, I have one kind of comment before we close and that is I am struck by the emphasis on the international. I cannot say I am so surprised but I am struck by the theme and the priority that seems to be placed on that.

One thing that would be helpful for us in your written comments or otherwise is--the way I think of it is what should our affirmative goals be in the international area. A lot of times, a worry that comes across as, there are these present meetings and these agenda items and these are the things that we have to answer, and I never feel like we are accomplishing as much as we could in that reactive mode.

If we want to be proactive and say, these are the things that we want to accomplish internationally--the seafood gave one good example of it in terms of getting more equivalency agreements and putting the foreign governments to work for us kind of notion. There is certainly one good example of that.

But in terms of what we want to affirmatively accomplish in the international area, if we had clear goals there, I think it would help us set priorities. If you could give some thinking to that, I think that would be helpful.

With that, let me thank each of you for your presentations today. This will conclude our morning session. We will reconvene in the splendor of this auditorium at 1:30.

[Whereupon, at 1:25 a.m., the proceedings were recessed to be resumed at 1:30 p.m.]

[1:30 p.m.]

MR. LEVITT: Let me welcome everybody back to our priority-setting meeting for the Center for Food Safety and Applied Nutrition. As I mentioned this morning, we will have a rotating set of CFSAN senior staff joining me up here so that everybody gets an opportunity to participate and to ask questions.

To my right is Kathy Carnevale who is the Director of our Constituent Operations, John Bailey who is the Director of our Office of Cosmetics, and Laura Tarantino who is the Deputy Director of our Office of Premarket Approval.

For folks that were not here this morning, let me just kind of quickly go over the format. I think probably everybody on the way in has a copy of the agenda. We are calling folks up in small groups that have similar areas of interest. We are asking for each person to do their presentation and then we are grouping the question and answer periods amongst them. And then we will just proceed to the next one.

There are a couple of specific announcements I am supposed to make so I don't forget. Number one, your visitors badge. For those that are coming back tomorrow, and I hope a lot of you will be able to come back tomorrow, please just keep your visitors badge. It will be good for tomorrow, also. You will be able to get in and out and you will have an easier time with that.

Second, some people have asked if we are going to have a mid-afternoon break. We are going to play that by ear in terms of how to program goes but we have a little bit between panels that people can get up and move around if they need to. If it feels like we need a break, we will use that option at the time.

One final thing is there were some questions if we would have copies of the slides that I showed this morning available. We are having copies made and they will be available when you leave, assuming you don't leave right away. Let that be a further incentive to stay.

With that, let us move to our next panel, our consumer panel. I am glad to see Michael Jacobson sitting right there in the front row. So, Mike, please come on up. If you want Bruce to join you, please do so.

We are trying to conduct this as a "looking formal but acting informal."

Summary of Proceedings | Panel B | Panel C