U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

FOOD ADVISORY COMMITTEE

MEETING

METHYLMERCURY

(VOLUME II)

Thursday, December 11, 2003

9:10 a.m.

Hotel Washington

515 Fifteenth Street, N.W.

Washington, D.C.

PARTICIPANTS

SANFORD A. MILLER, Ph.D., Chair

LINDA REED, Executive Secretary

MEMBERS:

ALEX D.W. ACHOLONU, Ph.D.

MARION H. ALLER, D.V.M.

H. VAS APOSHIAN, Ph.D.

DOUGLAS L. ARCHER, Ph.D.

FRANCIS FREDRICK BUSTA, Ph.D.

PATRICK S. CALLERY, Ph.D.

ANNETTE DICKINSON, Ph.D.

GOULDA A. DOWNER, Ph.D.

RICHARD A. DURST, Ph.D.

JOHANNA DWYER, Ph.D.

JEAN M. HALLORAN

DOUGLAS C. HEIMBURGER M.D., M.S.

NORMAL KRINSKY, M.D.

DARYL B. LUND, Ph.D.

MARK F. NELSON, Ph.D.

ROBERT M. RUSSELL, M.D.

CLIFFORD SCHERER, Ph.D.

CAROL I. WASLIEN, Ph.D., R.D.

C O N T E N T S

PAGE

Call to Order

Robert M. Russell, M.D. 5

Focus Group Testing

Dr. Marjorie Davidson 5

Questions of Clarification 10

Joint Advisory

CFSAN: Dr. David Acheson 18

EPA: Jim Pendergast 23

Questions of Clarification 36

Public Comments

Susan West Marmagas 83

Physicians for Social Responsibility

David Wallinga, M.D., MPA

Institute for Agriculture and Trade

Policy 90

Caroline Smith DeWaal 96

Center for Science and the Public

Interest

Carol Stroebel 97

Children's Environmental Health

Network

Robert Califf 104

National Fisheries Institute

Edward Groth III, Ph.D. 110

Consumers Union of U.S., Inc.

Michael T. Bender 118

Mercury Policy Project

C O N T E N T S (CONTINUED)

PAGE

Public Comments (Continued)

Susan Boehm, Ph.D. 125

New York Academy of Science

Jane Houlihan 132

Environmental Working Group

Rona Applebaum 157

National Food Processors Association

Diana Zuckerman, M.D. 167

National Center for Policy Research

for Women and Families

Dr. Joshua Cohen, 175

Harvard Center for Risk Analysis

John Stiker 188

Bumble Bee Tuna

Lillian Beard, M.D. 203

George Washington University;

Howard University

FAC Discussion and Comments 209

P R O C E E D I N G S

Call to Order

DR. RUSSELL: Since we are starting late, we thought we should go ahead. We have a talk today on focus group testing by Marjorie Davidson. Marjorie, please go ahead.

Focus Group Testing

DR. DAVIDSON: Thank you. Good morning. Carrying forth our discussion on the process that we went through in developing our Methylmercury Advisory, once we had our initial draft, we took it to focus group testing.

In the draft version that we took to our focus groups, I want to remind you that the message

was for pregnant women or women who may become pregnant, nursing mothers, and young children was included in the whole advisory this time, as well.

We have eight focus groups. They were geographically located throughout the country and we picked high fish-eating areas - Calverton, Maryland, New Orleans, Louisiana, Seattle, Washington, and Minneapolis, Minnesota.

We held mixed gender groups, as well as low education and high education groups. There were groups of pregnant women, women of childbearing age, and parents of young children. We held them in November 2001 and as Denise mentioned yesterday, it was an iterative process. We took the initial draft we had and modified it as we went along through the focus groups.

I would like to add that virtually everyone but probably one or two people was already eating within the limits of the consumer advisory, eating fish within those limits.

The goal of the focus groups was to examine risk communication formats, to look at various approaches we could use at explaining the risk of methylmercury in fish and also we wanted to see how these consumers would respond to the advice.

We were particularly paying attention to the three areas that were recommended by the Food Advisory Committee, the enhanced attention to young children that was not included in the advisory, the

merging of commercial and noncommercial fish, as well as a discussion of tuna.

We were continuing, as we have constantly done as we have been working on this advisory, we wanted to be sure that we kept a balance between letting consumers know about the risks of methylmercury in fish, and not jeopardizing their eating fish to get the nutritional benefits from it.

Our findings were that most people want a very simple message. This is not unusual for fish advisories, it is pretty much the case for all of our health education messages. People wanted to know what the arm was and they wanted to know how to avoid the harm.

As always, there were people who were greater information seekers, who wanted to know more information than the norm, and some of the things they wanted to know about were what exactly would methylmercury do to affect the health of the child, data about particular species of fish. They wanted to be able to look up this particular fish

they eat, and they also wanted to know how methylmercury would affect others, other members of their families, other members of their community.

Also, our results regarding tuna, we found that the difference between tuna fillets and tuna steaks, the different methylmercury contents versus white canned tuna was not known to most people. To most people, that was new information. As a results, some participants said that they would avoid tuna steaks and albacore tuna and move more to the lighter tuna.

The results of tuna in general, how they felt about their actions to tuna as a fish, I will talk about more in the general reaction to fish advisories.

What about recreational fish? Again, this is the first time we had merged the recreational fish advice with the commercial fish advice. We learned that avoiding commercial fish when you were eating recreational fish in the event that there was no fish advisory in a particular state was new information to many participants.

We also learned that people, for the most part, think of their fish-eating practices as holistic. They don't think I ate three commercial fish this week and two sport-caught fish.

I personally found it interesting that quite a number of people in these focus groups weren't aware that they needed to look at state advisories on the safety of their fish. That was surprising to me.

What did participants say they would do? Almost all participants reported that they do not eat fish. This was not particularly difficult to do since most of them did not eat that species of fish anyway, but some participants said that they would eat less fish and some participants said they would serve less fish to their children, and this was the same as the description of what they would do with tuna.

Another finding that we found, there was a spillover effect as actually was the case in our first set of focus groups, as well, that once they learned there was a risk of methylmercury in fish,

they thought it was important to tell others about it, because if it wasn't good for a pregnant woman or a young child, it probably wasn't good for them either.

So, in conclusion, I would like to say that it is our belief that women will follow, they won't exceed the safe fish advisory, however, we will be challenged to ensure that they continue to eat fish and gain the nutrients from it.

DR. RUSSELL: Before you start the questions, I just want to remind you to turn off any cell phones that you have or turn them to vibrate at any rate.

Questions, please.

Questions of Clarification

DR. DURST: I was just curious, how were the participants in these focus groups selected? I mean as far as the breadth of their education, and so on.

DR. DAVIDSON: We had separate groups, which were high school graduates or less than high school, and then we had groups that had some

college or had finished college, and then we had some that were a mixture of the two.

DR. APOSHIAN: I am very ignorant of focus groups and I wondered, is there any evidence that validates the use of focus groups for this sort of thing?

DR. DAVIDSON: Well, they are used traditionally to find more patterns of response from different kinds and groups of people. It is a research tool that is used frequently in social science research.

DR. APOSHIAN: If I were doing a study and published something, one of the first things that a referee would ask is how do you validate the analytical techniques you are using, and I am curious and wonder whether there is some reference that is available to us to validate the use of focus groups to obtain this kind of information.

DR. LUND: I am not a sensory scientist, but the use of focus groups in a wide variety of industries, particularly the food industry, is well documented and I think there would be books and

other materials that would have been peer reviewed, in fact, attesting to the validity of using focus groups.

DR. RUSSELL: Dr. Scherer.

DR. SCHERER: The use of focus groups, keep in mind, really, the objective is to get them to help you with the message in this case. I don't think there was any attempt to really try to use it to get a more demographic profile about how people react to the message. It was for improving the message over time, getting people to interact.

But I guess my question would relate to the extent to which different demographic groups, particularly, for example, Asian groups, might react to the message in a very different way.

It would seem to me that one of the issues might be that certain groups--again, I refer to the Asian group--may eat a narrower range of fish, they may have different names for the fish, there may be other kinds of issues that are relevant to particular demographic profiles.

I was wondering whether there was any

thought given to examining other groups, for example, a focus group specifically with

Asian-Americans or some other.

DR. DAVIDSON: We haven't formally through FDA, but we are informally working with folks in California right now, with the State of California, as well as our local public affairs specialists in the field there, and trying to see how this advisory could be translated into that community. I totally agree with you.

DR. DURST: It was just to follow up again, but I think your comments clarified, because I was a little concerned that with the focus groups, that if they were not representative of the general population, you were going to get a biased result.

That was my original question about how these people were selected. If they were volunteers, again, you are going to get people who are more proactive in things and would not be representative.

DR. ACHOLONU: As a follow-up to that, I

was wondering about the focus group. Did you include the African-Americans because it is believed that this group eat more fish than other groups?

DR. DAVIDSON: African-Americans were part of these focus groups. There wasn't a special African-American focus group.

DR. SCHERER: I had one other question and this relates more to perhaps a little bit broader issue than just the focus groups, but it seems to me that going through a process in which we evaluate the message and have some understanding of how people are reacting to that message is really only the first step, because it seems to me that the real issue is the behavioral step.

That is a much more difficult one to try to analyze and understand, yet, in a message as complex as this particular message, it seems to me that that is really what we are trying to do.

We really would not want people to, number one, stop eating fish as a result of seeing or remembering one little bit of the message, and at

the same time, we don't want them to say yes, I understand the message, but I am going to ignore it.

So, it seems to me that that is the real component of trying to understand. I realize that that is a very difficult thing to begin doing, but I am just wondering whether there is any thought about giving some effort to try to understand at least behavioral intent, if not actual long-term behavioral measures.

DR. DAVIDSON: How it is planned further than what I reported on at this moment, but we are also not finished with our efforts in this regard, as well. I appreciate very much what you are saying.

MS. HALLORAN: I think that is a very interesting point. You obviously reported some statements of intent about behavior. I don't know if you have a way to follow up with the members in six months and a year to see if they report actually changing buying habits.

DR. DAVIDSON: I would not surmise that we

would be following up with these particular members, but we do have evaluation techniques that we will undertake at FDA, more of a survey nature actually, to find out what people are actually doing regarding the fish advisory.

DR. DOWNER: I have conducted several focus groups for different things myself in terms of health. I am just curious, can you tell me exactly how the focus groups were done in terms of exactly what you did as you got the groups together?

I have found that when you select a group and you have somebody who is very vocal, that they can easily sway the discussion and the intent is changed. So, what I usually do is I have something in writing for people to fill out the form and then go into the discussion.

Can you tell me if you did something like that or it was completely discussion? The information you gathered is very important and was very worthwhile actually, but I am just curious to see if there are one or two persons in several

groups that had the majority input and you didn't get some more substantive supplemental information from other members of your focus group.

DR. DAVIDSON: I certainly agree and appreciate the comment that you are stating. I actually did not do the focus groups, we hired a professional company to do them, who are skilled in turning the discussion away from folks that tend to dominate.

That was also one of the reasons why we divided education up for the most part, so that the higher educated people didn't dominate the group.

DR. DWYER: Dr. Russell, could you just tell us or could someone tell us - we have got a bunch of press releases here, one of which seems to be from this year, one of which seems to be from last year, and one of which seems to be from the year before.

I understand why the press release from this year is here, but why are the others here, just as background, or what?

MS. REED: Can you just tell us what you

are referring to, Dr. Dwyer? These were all distributed this morning, I am presuming by public commenters, that we will be hearing from this morning. It's just background information.

DR. DWYER: Oh, I see. Fair enough.

DR. MILLER: I want to, first of all, apologize for being late. It just took two hours to come in from Bethesda, normally, a 25-minute drive. I am not sure whether it was this meeting or it was the weather.

In any case, we now have come to the essence of the discussion, the presentation of the joint advisory.

David, you are going to start out?

Joint Advisory

CFSAN

DR. ACHESON: Yes, Dr. Miller. This again is going to be a joint effort between myself and Jim Pendergast from EPA, and I am just going to give a little introduction and overview of some of the major changes in the new advisory and then hand over to Jim to continue.

These first few slides just summarize some of the major points in response to the recommendations and how we have tried to incorporate those into the revised advisory.

The first point is that this new advisory does cover both commercial and recreational fish and shellfish as part of the joint effort between FDA and EPA.

Secondly, this revised advisory is directed towards pregnant women, women who may become pregnant, nursing mothers, and young children, and that, as I explained yesterday, is a slight departure from what FDA did in 2001 in that there is more emphasis on young children than we had in the past.

The third major issue in response to the recommendations, the Do Not Eat list, that is unchanged, there was no recommendation to change that, and again as I pointed out yesterday, we do not have new data, new science that would suggest that we should change that, but clearly, we will keep an open mind, and as we pursue testing on, for

example, tilefish, we will revise the advisory accordingly.

The fourth point in relation to the amount, again, the amount, the 12 ounces has not changed. That was the same as 2001. What we have done is we have tried to clarify that message in response to the request or the recommendation from the committee to be more specific about variety.

As we explained yesterday, we have found a way to do that through new language, and as you have just heard, that has been tested in the fact that we are now saying two to three servings. So, that is how we responded to that.

The fifth point in relation to locally caught fish. The advice on the amount of the locally caught fish again has not changed. It is the same as in the 2001 EPA advice. But what we have tried to do is to clarify this issue of don't consume locally caught fish and commercially caught fish in the same week, so that there is a better understanding of that issue.

Finally, again, this was really in

response to focus group testing and what worked the best was that we have developed a series of questions and answers on specific points, and that is a departure from the 2001 format, in fact, it is quite a significant departure.

As you will see on the draft, we now have a series of questions and answers that cover a variety of issues. We certainly don't intend that this is going to be a compendium of methylmercury in fish.

We anticipate that people may have other questions, so we provide a hot line number, and we provide a web site which we would augment with data and information and keep updated again with specific amounts of methylmercury in the different fish species as we develop it.

The one point again I want to emphasize in relation to the Q and A is what we said about tuna, which I did mention yesterday, and the bottom part of this slide just is the quotation of our answer to that question.

I am not going to re-read that, but I just

want to point out that we are now saying something specific about tuna. We decided that a factual statement about tuna was the most appropriate way to go and added the statement at the end that you can safely include tuna as part of your weekly fish consumption diet.

Now, that statement, linked with the second rule in the advisory, would indicate that if you mix up the fish, as we are recommending, and you want to consume tuna, then, you would essentially be consuming four to six ounces of tuna a week, because you would only eat one type of fish per week. If you have eaten one type of fish, then, you need to do some other kind of fish, some other type of fish if you are going to have a second fish meal.

That really summarizes the main issues and I really just wanted to pick those out and focus on them just briefly before handing over to Jim Pendergast, who is going to take you through kind of the full advisory from beginning to end, so maybe you can defer questions on this part until we

are completed.

Joint Advisory

EPA

MR. PENDERGAST: Good morning. I guess this is the part that folks have been waiting for is what is the draft advisory. As Marjorie had said, during the focus groups, we had tried different types of the advisory, we learned as we went along. If the message wasn't getting across, we tinkered with it and tried to make it more clear and tested it at the next focus group.

So, what you are going to see on here is what has resulted from the process of going through the four focus groups.

The draft advisory has three parts. There is a risk message, what is the risk, there is the consumer advice, and as David said, there are some Q's and A's that we put at the end to help provide some more information. A lot of the reasons for these Q's and A's came about from some of the questions that we heard at the focus groups.

The first part of the risk message is who is at risk. It is in the title of the document

itself, women who are pregnant, who may become pregnant, nursing mothers, and young children.

We also explained why they are at risk and we talk about the benefits, the positive benefits of eating fish. We want to make sure that that point comes across, and that is something you also heard from the focus groups, why should we eat fish, and also point out that what are the potential problems of eating fish that are high in methylmercury. That is part of the risk message.

Precisely what we say is that, "Fish and shellfish can be an important part of a balanced diet. It is a good source of high quality protein and other nutrients and is low in fat. The FDA and EPA are advising pregnant women and nursing mothers to eat the types and amounts of fish and shellfish that are safe to prevent harm to the development of their baby or young child."

We also provide a statement that, "If you follow the advice given by FDA and EPA, you will gain the positive benefits of eating fish but avoid any developmental problems from mercury in fish."

Again, this something that we heard from the focus group is that why should we eat fish and what is wrong about eating fish that are high in mercury.

The second part of the advisory is actually the advice to the consumers. We have tried to break it down into three parts. We tried to get it to a message that was clear, so the results in the focus groups, that the feedback we got from them is that they understood what the message was and they would be able to tell us how this might affect their behavior.

The first part is similar to what we had in the 2001 advisory. There are four types of fish based upon the information we have that we recommend that the target of the advisory, pregnant women, women who may become pregnant, nursing mothers, young children, don't eat the four fish we have here: shark, swordfish, tilefish, and king mackerel.

The second rule is the part that David talked about just briefly before, is that we recognize that levels of mercury in fish can vary,

and we recommend that you can safely eat up to 12 ounces, which is two or three meals a week, of other purchased fish and shellfish a week, but mix up the types of fish, and do not eat the same type of fish and shellfish more than once a week.

What we mean by this is that, for example, if a pregnant woman was going to have a meal of tuna, which is 4 to 6 ounces, that that would be the sole meal of tuna that week, and that she would balance that with eating a different type of fish that week.

The same thing is that if a woman was eating, let's say, grouper, that would be one meal of grouper a week and balance it with different types of fish.

As we have talked before, is that in the implementation that we will be having up on the FDA website and links from the EPA website to what we know about levels of mercury in fish, so that the consumer who wants to do research for himself or herself can go and look and find what types of fish that perhaps are lower in mercury and choose how he

or she is going to construct their diet. That is a piece of information to be able to help.

The third rule is the rule that brings in the role of local advisories. What we are saying is for people to check their local advisories about the safety of fish caught by family and friends in your local rivers and streams. If no advice is available, you can safely eat up to 6 ounces, one meal per week of fish that you catch from local waters, but don't consume any other fish during that week.

We needed to do this because across the United States where people are catching fish, the amount of mercury in fish varies, and vary for something as low as 0.05 parts per million as an average for species up to almost 0.9. This varies based upon the type of species, the location, the age of the fish.

States have already issued advisories based upon what they know from data that they have collected. We want to make sure that consumers know about this information. This is the reason for

this third rule, and it is part of the implementation links that go from here to a website that we have in EPA that links to advisories that states have issued around the country.

We also recognize that states can't be everywhere and test fish everywhere. What to do about those waters where a state has either not issued advisory or doesn't have any information to be able to say that folks can safely eat fish at 8 meals a month, 12 meals a month, or something like that, that is the reason for the 6 ounces, it catches where we don't have information, and it is based upon what we know from where we do have information and taking a look at essentially a median of the various species, so that folks can have some level of protection or some level of knowledge in terms of what they can safely eat.

Recognizing that concentrations can be high in some of these fish, that is why we came up with the recommendation that if you eat that one meal a week of recreationally caught fish, that's it, don't add anything else to it.

In recognition of small children, we also recommend that the people following the advice follow the same advice with children, but recognize that children have smaller body mass and they tend to eat a little bit less, that they should eat less fish or less than the 12 ounces.

Now, the Q's and A's. Again, this comes from the balance of how much information you put upfront in an advisory that gets the message across without overwhelming people so that they lose the message.

It also comes from the part of being able to recognize or to respond to some of the questions that we got or that we heard from the focus groups, the questions that they asked the moderator, places where they said they needed more information.

One of the most frequently asked questions that we heard was, "I thought fish was good for me. Why are you telling me that I should constrain the amount of fish that we eat?"

We tried to answer that. It is, that is, fish and other seafood have long been considered to

be good sources of protein with the added advantage of being low in saturated fat and high in healthy omega-3 fatty acids. However, scientists have learned that shark, swordfish, king mackerel, and tilefish contain levels of mercury in them that may harm your unborn child.

This is why FDA and EPA are advising you to avoid these fish. By eating other types of fish in moderation, you will get the health benefits of fish, trying to directly respond to the concerns and the questions that we heard at the focus groups.

The second question is about tuna. David went over this question before, but this was also a question that came up as folks would ask that question, what about tuna, and they did not understand, as Marjorie said, the differences between the mercury levels in albacore tuna and tuna steaks as compared to the chunk light tuna. We wanted to be able to provide that information to them.

The third question is, is methylmercury in

all fish, and this is recognition of the idea that there is a natural reaction of fearing that there is something bad in your food, that people may run away from that food completely.

We know that there is methylmercury in all fish, and we needed to be able to provide the appropriate information for people to understand that it is the level of mercury that is important in the amount of fish they eat, not the fact that there is some measured mercury in a fish.

So, we answer that by saying nearly all fish contain traces of methylmercury. However, larger fish that have lived longer have the highest levels of methylmercury, so they have had more time to accumulate it.

One of the questions that Marjorie pointed out is people wanted to know why is there mercury in the larger fish.

Other types of fish are safe to eat, if you want more information, where to go for the information, trying to respond again to the focus groups.

Another question that came up in a couple of focus groups is, "But I am not pregnant, so why should I care about this?" Some of this also came to a point that was made in a couple of the groups, that not every woman intends to get pregnant, and therefore, women need to understand the message if they could become pregnant.

This is a very important point that we needed to clarify, because at one group we actually heard a woman, who to me appeared to be in her 30s, said, "I am not going to have any more children, so can I just eat all the fish I want?"

This is to try to answer that question, that mercury can accumulate in your bloodstream over time, it is removed from your body naturally, but it may take over a year for the levels to drop significantly, therefore, it may be present in a woman even before she becomes pregnant. That is why it is important, of women who are of the age that they could become pregnant, and we also suggest that if they have questions about a concern that they may have consumed large amounts of mercury, to

talk to their physician.

Another question that came up is about the local information, why be concerned about the local information about advisories. We tried to address that, as well, to explain that some kinds of fish and shellfish may have higher or much lower than average levels of mercury. Like I said, from the information we have based upon species, it can range from 0.05 parts per million to almost 0.9 parts per million. That is an order of magnitude variation.

This is the reason why people, this is how we try to answer why folks needed to understand about locally caught fish.

Another question that we heard is how do I get this information, how do I learn about local advisories, and we try to answer that question by pointing out that states have fishing regulations booklets, some of them do. You can contact local health departments, and we also provide links to state and tribal contact information.

One of the last questions on here is what

is mercury. Recognizing that mercury is an element and it has been around, that it occurs naturally in the environment and also can be released into the environment, from our view, primarily from air emissions through industrial pollution.

It falls from the air, accumulates in streams and oceans, turned into methylmercury in water. We try to provide that information. We did hear folks who asked questions, well, how does mercury get into the fish anyhow, and this provides some of the basic information, so that folks can understand.

At the very end of the advisory, of course, we provide links to where to go for more information, both with FDA and EPA with websites, and in the case of FDA, with their hot line.

We also provide links to the state and tribal public health offices that issue fish advisories, so people can very quickly find where the local advice is.

Lastly, where are we going from here? The advisory we have right now is draft. We are

seeking input today. We have some other steps along the way. As Marjorie said, we did talk to focus groups.

Back in July, we had a stakeholder meeting where we talked about some ideas, but in the future, we have a National Forum on Contaminants in Fish that EPA co-sponsors with ATSDR. We will be discussing with state and tribal public health officials the draft advisory, get some of their concerns and ideas on that and what we need to do.

We are targeting to be able to come up with a final advisory by February, after receiving the input that we can possibly gain on here, again with the overall idea of having a message that is able to capture the sense that it is important to eat fish, but it is important not to eat too much of the wrong fish, and to try to get that simple message, so that people understand that and change their behavior to follow that in ways that protects their house.

Following that, in 2004, we, in FDA, will actively engage in getting this message out. We

have not yet sat down and worked out all the various ways in which we are going to do it, we have just been working on the draft advisory, but we recognize that getting an advisory done is just the first step. The next 10 steps is in the effective implementation.

With that, I think that closes this presentation.

DR. MILLER: Thank you.

Questions of Clarification

DR. ACHOLONU: I noticed that in your presentation, Item 7 has what is mercury. I have a copy of the draft advisory here. It does not indicate what mercury is, but goes on to say, "Mercury occurs naturally in the environment." Don't you think that you should include what mercury is?

MR. PENDERGAST: That is a good point on here, and I actually said it myself, showing a little bit of what I know, that mercury is an element. It might help to start off with saying that.

DR. MILLER: Dr. Scherer.

DR. SCHERER: I would like to first congratulate you on all the work you have done in terms of structuring the message, because I think often we end up with messages that people just write and think that's the way it should be done, so that you have had a lot of input into the message.

You seem to have arrived at a message that is understandable by focus groups, but I wonder if there is a point at which, in a sense, we have simplified a bit beyond meaning. Let me try to explain what I am talking about.

I guess I am one that advocates that we need to simplify messages for people to understand, but if we lose what the science and the meaning is about, then, I have concerns.

The message essentially says do not eat the same type of fish each week, and I understand why the message is that we should eat a mixed grouping of fish, but as a consumer I look at it and say wait, I eat trout, and I look at the list,

and if I eat anything other than trout, I am increasing my intake of methylmercury.

So, somewhere I may be losing some of what the message is trying to do. Does that make sense to what I am asking?

MR. PENDERGAST: It does, and I think we thought about this at the same time, how do you get that type of information in people's hands for making decisions. That led us to developing the database or the list of what we know about levels of mercury in fish and to make that available, so that in the case that if you ate trout, and you would be looking for something that was lower in mercury.

DR. ACHESON: My perspective on that is this is a balance between once you have eaten your portion of trout, you think, well, I know fish is good for me, what should I do next, and the idea would be that you would have something else that week.

If you really want to go and investigate, you could look up on the web and say, okay, I

really want to keep it low, which is why we have also gone for the 12 ounces, because we figured that if you have had your portion of trout, say, 6 ounces, and you want to eat another serving of fish, another 6 ounces of something, so long as you have got the mix-it-up message, you are going to go for something different, and it will still keep you safe even if you don't want to go and investigate.

Then, you can certainly eat trout again the following week. This is sort of going week by week. But I agree with you, it is difficult to keep it understandably simple and yet not lose the science. We have tried to get that balance and certainly if you have some perspectives that could help ensure we maintain that, we would love to hear them.

DR. MILLER: Dr. Krinsky.

DR. KRINSKY: It seems to me there is a huge difference between reading the advisory and listening to the presentation that Dr. Pendergast gave, and listening to it makes it so much clearer if I try to put myself in the position of a

consumer, of a pregnant woman or something of that nature.

So, I just wonder, in the focus groups, were they simply given the draft advisory without any comment from the individual who was administering the focus group. I don't know how focus groups function, so I just wonder if I could get some clarification on that.

MR. PENDERGAST: Yes. The way that the focus group worked, and the participants were in a room with a moderator. The moderator read the advisory, that current version of the advisory, and then people reacted to that. There was no explanation that was given by the moderator.

We did break it up into two parts. The first part was the risk message with the consumer advice as one part, and then the participants discussed that. Then, we went for the Q's and A's.

What we learned from that part was that a number of the questions that people had popped up when they read the advice, like isn't it good for me, isn't fish good for me, and things like that,

and the Q's and A's then answered those questions on there, but there wasn't any explanation by the FDA, EPA, or the moderator as the focus group went on.

DR. KRINSKY: So, the focus group was given the full document that we were presented with.

MR. PENDERGAST: They were given the version at that time, the draft advisory evolved. The group in Calverton, which is the first one, had the first iteration of it, and then we learned from that. We made a second version, and then the group in New Orleans had the second version. We learned from that and made some revisions to it, then, Seattle, and then revisions, and then Minneapolis.

So, what you see is the culmination of four iterations and learning from the four groups.

DR. KRINSKY: So, how many focus groups received the document that we are reading now?

MR. PENDERGAST: The precise document?

DR. KRINSKY: The precise document that we received.

MR. PENDERGAST: None of them, because this represents the last change from the Minneapolis one, however, the change from Minneapolis to what you see in front of you was very small. The largest change was after the first group, and the groups in New Orleans was the second group, saw pretty much the same language, the three parts of the message, the Do Not Eat, the 12 ounces and mix it up, how to integrate the local advisories, they saw that.

Where we spent most of time in the revisions was in the ordering of the questions and precisely which questions.

DR. KRINSKY: Thank you.

DR. DOWNER: Thanks for a very informative presentation. I decided to take in a few of my teaching tools for my consumers and patients to let the committee see what a serving of tuna looks like, and this is not a lot.

So, when we are hearing 12 ounces, 12 ounces compared, for example, to 3 ounces of hamburger patty, it looks a little bit more

substantial than this 3 ounces or this quarter cup rather, of tuna. It is not a lot of tuna.

My challenge is in talking to patients about increasing their fish consumption, when you hear limit, along with it you hear avoid, and that is a big challenge. That is the big challenge, how do we get the message out to say yes, we say to limit, not avoid.

So, the slide that says how much fish to eat, the consumer advice, how much fish to eat, do not eat shark, swordfish, I would like that slide to include what to eat. The method is too far removed.

The very slide that says do not eat so-and-so, I urge you to put instead eat so-and-so, et cetera, and you can give a reference to where they can go on to get other information, because it is easy to just look at this and say oh, I give up, I give up.

One week you say or one year you say eat more fish and cut out the red meat, the next time I am hearing eat less of this, I am confused, so I

give up. So, I urge you on this very slide that says do not eat shark, put the positive message with it. That is the only thing, as consumers and as clinicians--I am a nutritionist in clinical practice--will give to my patients and say here, this is the other side of this.

MR. PENDERGAST: Thank you.

DR. MILLER: Do you have another comment?

MR. PENDERGAST: No, I think that is a good piece of advice for us to consider.

DR. MILLER: Jean.

MS. HALLORAN: If I understood the presentations correctly yesterday, from the exposure analysis, I think it was quite clear that you actually, for 98 percent of the population, can achieve the desired exposure only if you eat 12 ounces of low mercury fish, and it won't work if you are mixing it up with middle mercury fish.

So, is it correct that if you, for example, had grouper, orange roughy, and albacore tuna for your mixed-up variety that week, isn't it correct that you would be over the reference dose?

DR. ACHESON: The short answer to your question is if you were to eat grouper--what was the--

MS. HALLORAN: Orange roughy and albacore.

DR. ACHESON: Yes, and if you were to eat 4 ounces of those, based on the means, you would be over the RfD, yes. We regard the RfD as an important guideline as to where to target.

As the discussion has gone on, what we are trying to do here is to achieve a balance between the health benefits of fish and the dangers of methylmercury.

The exposure assessment is a model and it was a very useful guide to keep us on track. What we took from the exposure assessment was that if we can get the word out, we will be improving over current baselines.

We may not get everybody below the RfD, but we will do better.

MS. HALLORAN: But you are quite definitive in the advice. You say you can safely eat, safely eat, and yet it seems to me your

analysis shows actually that you can only really safely eat the bottom 20 fish, so I would actually like to second the suggestion of Goulda that perhaps you could say safely eat 12 ounces of low mercury fish and then list half a dozen of them, and encourage eating those, because it is quite a long list.

DR. MILLER: Dr. Dickinson.

DR. DICKINSON: A lot of people are eating more fish now because of concerns about omega-3 fatty acids, getting more omega 3 fatty acids, and, in particular, they are turning to salmon, because they all know that salmon is one of the high sources of omega-3's, and fortunately, salmon is also one of the low category for methylmercury.

So, it seems to me that it would be very beneficial for people to know that even several servings a week of salmon would not put them above that level, and if that means giving them more advice on the entire selection of low mercury fish, I think that would be very positive, but, in particular, I think they should know that salmon is

one of those low mercury fish, and that if they are seeking to increase their omega-3 levels through eating salmon, they can safely do that.

In fact, I think it is not quite true what it says about not eating the same fish more than once a week, because if you are eating from the low end of the list, and, in particular, if you are eating salmon, you may be quite well off eating more than one serving of those kinds of fish a week.

DR. ACHESON: Those are excellent points. The first draft that we tested, we put in a list of low fish, included salmon, light tuna. It didn't work, people didn't understand it.

What we are hearing here is somewhat of the same thought process that we went through - why don't you list them, why don't you do this, and where we have tried to end up with is a balance between what is understandable and what people can do considering this is a national advisory.

We have certainly gone down that road of, well, let's list everything.

DR. DICKINSON: But there is a difference between listing everything and mentioning the two or three things that people eat the most of, and salmon is one of those.

DR. ACHESON: I agree with you, and that is exactly what we did in the first draft. If you look at the first draft--I forget which tab it is in the notebook--but where we have those three drafts in there, that is in there, in our variety explanation, and the focus groups didn't understand it.

DR. DICKINSON: Well, that may have to do with the way it was said, as well as with the message itself, but I think that is worth another look.

DR. ACHESON: Thank you.

DR. MILLER: Dr. Durst.

DR. DURST: I just have a few comments, several of them. I agree completely with my colleagues that my first reaction when it talked about mixing the varieties of fish was that it added confusion to me and, just to reiterate, that

if you pick low mercury-containing fish, you can eat as much of that as you want without having to mix the species. So, I think that phrase in there is more confusing than helpful.

On the point of mercury and what it is, the way it is stated in here, mercury occurs naturally in the environment, it is really mercury compounds, it is not the element, it doesn't exist in nature, so I am not sure if we want to get into all the science of it, that it's an element, which would be more or less meaningless to most of the population.

I also agree that the three rules, the positive points should be emphasized, No. 2 maybe moved to No. 1, and I would recommend dropping out the mixing of the types.

Finally, I think in presenting this in the final document, it would be nice to highlight just important aspects of it. There is a lot of verbiage in here that the consumer might be interested in, but they are going to see a two-page document that is going to be intimidating to most

people who won't want to read through the whole thing, but if you highlight and bold in some way some of the main points, this might actually get the message across.

Then, if the people want more information, they can read the fine print, if you will.

I would also like to see some kind of a listing of the fish with the ranking as far as the amount of methylmercury in them. One of the documents we were given this morning from the Consumer's Union has a nice table of that sort, and I would recommend providing at least that kind of information.

MR. PENDERGAST: Those are very good thoughts in there. Those are some of the things that we are also wrestling with is that, how much information can you put out before people stop reading.

That is what led to the format that you have in front of you, where I think in one of the first iterations, some of those questions and answers for part of the verbiage of the advisory,

and people in the first focus group could not get past that.

They had gotten to that first paragraph, which is about what was mercury and where is it in the environment, and then they started getting worried, because they never got to the actual advice.

Some thoughts, you know, I appreciate thoughts in terms of how to help focus people to where the thoughts are in there. We also had some thoughts about, you know, putting the information about fish and methylmercury content in the fish.

That table, in itself, could depending on the number of species in there. Again, since it is national advice, we want to be able not just to give examples, but to be able to give all the information you have, because people eat different types of fish.

We agonized over how to do that and came up with having a web site where not only would we be able to put a longer list on there, we would be able to update it. Instead of having to have

printed advisories out and have to continually change what is in print, we would be able to continually change what is there on the website, so people would have the most current information.

DR. DURST: Well, the only problem with the website, it is only going to hit a certain portion of the population, not the poorest segments and that sort of thing, so I think the website is nice for the Internet-active type people, but it is going to miss an important segment of the population.

DR. MILLER: Dr. Russell.

DR. RUSSELL: I actually liked the advisory very much, I think it is quite clear. I think it can be tweaked some, but I think it is a really good job.

I wondered, however, there is just one little thing that came up in my mind, why, at one point, 12 ounces is defined as two to three meals, whereas, 6 ounces is defined clearly as one meal per week. I just wondered why the two to three if you are trying to make the message very clear.

MR. PENDERGAST: That is a good point. Do you know that meals depending upon--are people's choice. I know that my wife's meal and my meal are different sizes on there.

DR. RUSSELL: I realize that, but in trying to make it clear, I just wonder whether people would start thinking is it three I could eat, or two, or one, or I can't remember.

MR. PENDERGAST: That is a good point. We will really consider that one.

DR. MILLER: Dr. Aposhian.

DR. APOSHIAN: I just have three comments I would like to make. I agree with Dr. Krinsky as to the presentation seemed to be different than the advisory. I have lost count because I was interested in what someone else said. You mentioned tuna fish many more times in your presentation than it is mentioned and cautioned about in the advisory. That is number one.

Number two, as Dr. Durst was saying, the poor group, the uneducated group, if you will, the immigrant group, if you will, may not read

something this long. I think we have two extremes.

You have the Ph.D./M.D. who is so busy that he is just going to read the first line, and then you have the poor people who either have to work for a living and don't have the time, but you ought to read the paper that the good people from the EPA have put out on environmental health perspectives, and it points out that as far as racial or ethnic groups are concerned, Asians, Native Americans, and Pacific Island women have anywhere from at least about one point times higher amounts of methylmercury than do the so-called white Caucasian American.

So, I think what Dr. Durst was saying is to reach that group that is not as highly educated, that may not have the time or the desire to read something this long, my suggestion would be, as Dr. Durst made with highlighting, is maybe even using bullet statements that will get across.

I have one more comment, that I hope an FDA attorney looks at the consumer advice that says benefits and risks. If you follow advice given by

FDA and EPA, you will gain the positive benefits of eating fish, but avoid any developmental problems from mercury in fish.

I don't testify in court anymore, it is just too much trouble, but that would just increase the consulting fees of most toxicologists that I know that do go before court, and I think that is a very dangerous statement for a governmental organization to make.

MR. PENDERGAST: I appreciate the advice on there. That is something that I know that attorneys would take a look at.

Getting to your comment about the length of the advice and message, that is something we also think about on here. As we get into the implementation in terms of how does this message get out, certainly we know that people will be taking it, paraphrasing it, putting it into publications.

Within EPA, we have worked joint with ATSDR in terms of getting pamphlets out in the hands of pediatricians and OB-GYNs to be able to

help pass the message on. We even have pamphlets in Vietnamese, Hmong, Spanish, and other languages to be able to get to the people who actually eat higher fish than the national median to be able to get the message out in their language that they best understand, to be able to do that.

We are going to be looking at doing some of those same things because the important thing is to be able to have something which then helps generate the various different ways in which the message can go out, you know, press, consumer advisories by states, pamphlets we put out, pamphlets states put out.

That is going to be where taking that message and putting it into real terms is going to make the difference.

DR. MILLER: Dr. Scherer.

DR. SCHERER: Just a few minutes ago there was some discussion about the advisory starting off with, "Do not eat shark, swordfish, mackerel," and so forth. There is a phenomenon known as primacy and recency meaning that when we are hearing

information, we tend to remember the first and the last.

So, it would seem to me that some attention really needs to be given to how the advisory is organized, because it seems to me that starting out with "Do not eat" says that's the most important part, and if that is what we want people to remember, that is the part of the message they will remember.

On another topic, thinking about--and I keep going back to the idea of the behavioral, because it seems to me that that is really our bottom line. If people go away from this being confused because of the complexity of the message, as simplified as it is, we still haven't succeeded, and I wonder why you haven't gone to something like--I am looking at the Minnesota one that is here in front of me--that gives the simple behavioral rules to follow when you are interested in consuming fish.

Most people, most of us have very simple behavioral rules that we follow. When you go to

the grocery store, you don't go through all of the cereal reading the labels to decide what you want. You have a very simple behavioral rule what you are looking for, and it is probably a particular brand.

So, I wonder if the kind of structure that the Minnesota one uses, that is giving those very simple behavioral rules would not serve a majority of the people better than a longer narrative kind of description.

Secondly, it seems to me that we have to keep in mind, and some of you hinted at it, that all the consumers aren't the same. Some want those very simple behavioral rules. Other people do want more the arguments about why should I follow those behavioral rules, and still others in this room want data.

So, the levels need to be there to the extent possible, and it seems to me that you were mentioning the web, that despite the fact that we could argue that the web will not serve most consumers, there will be consumers that want that depth of information, and it should be available on

the web.

So, I think the kind of linkage between the levels of message, in fact I would even include the web link right in the message, so that people who want more information can go and get that message.

But I guess my real question is whether you have given some thought to trying to come up with a behavioral structure of a message here is the kind of advice that is given specifically.

This is talking about if you eat two to three meals of fish per week, they can be from this group or this group.

DR. MILLER: Dr. Dwyer.

DR. DWYER: Thank you. I share Dr. Russell's concern about portion size, and I think it would help if all government materials used the same portion sizes. I know FDA, USDA, and other agencies sometimes use different ones, so we have to get on the same page particularly in the same advisory on a portion size, but it should be uniform with what other government agencies are

doing.

It seems to me there are four forks in this advisory. The first is are you pregnant or lactating or a young child, and that M.D./Ph.D. guy that you were talking about would go and he could eat all the fish he wanted, but if the answer is yes, then, the next thing is this business of no big fish, the four big ones.

I think in the previous two or three days we spent on this, we talked about common names, and there are common names for some of them, and they are not in this. I imagine you will tell me that, well, this is for the nation and therefore the common names change from one place to another, therefore, we won't put the common names in, but it seems to me if it's consumer communication, you are going to have to, so it's no big fish is the second fork in the road.

Then, it seems to me--maybe I am still confused about this advisory--that then there is a fork--back to this behavior stuff that Dr. Cliff was talking about--I don't think most people really

call their local health department and check about advisories, so you have to have a rule for those lazy people like me.

That would be I think you have said it's no more than 6 ounces--if you don't know in the advisory--it's no more than 6 ounces of game or sport-caught fish. Right?

DR. SCHERER: Right.

DR. DWYER: Then, the last fork in the road is this one on variety, and it's something, 12 ounces of variety of other fish a week. The problem I have got is that I am not going to do that. Now, hopefully, I am not going to get pregnant either.

[Laughter.]

DR. DWYER: I am not going to do that. I want advice about the fish that I eat, and the fish I eat unfortunately are those available in cafeterias, and it tends to be something, I can't tell what it is because it is covered with mayonnaise, but it is probably some kind of tuna fish, and it is probably like tuna fish.

So, I want something more specific than that, that variety message there, because I am not going to change my consumption. I want to know what I am going to do within the consumption. I think it is highly unrealistic to think that we can change people's consumption to orange roughly or to something else away from these other fish.

So, the common names, the serving size, the fact that people don't mix things up even though we want them to, the issue of too much verbiage. If you think about it, the Ten Commandments are about a third or less or maybe a tenth of the list of this advisory, not that people follow that behavior either.

[Laughter.]

DR. DWYER: Then, the final issue about there are other groups and other agencies of government. Certainly I don't want to hang crepe around fish, but the point is I don't think that FDA's first mandate is to promote fish. I think the first mandate it to promote the public health, and in this specific case, to avoid a contaminant,

so I am more concerned about that than I am these other things.

I think other folks and other parts of the government and other kinds of advice are going to get that larger and important message as well out.

MR. PENDERGAST: Thanks.

DR. MILLER: Dr. Waslien.

DR. WASLIEN: I follow on what my colleague said, but I am not all together sure that the message gets out that not everyone in the household should drop fish. The first point doesn't say that for everybody else it is okay, it just says for women.

I think that one of the comments that was made even by the group talking about the focus group presentations says, well, then, we have dropped fish, and they haven't dropped it just for the woman or even for the children, they are dropping it for everyone.

What made me also react is, you know, this Washington Post made a comment that the Bush Administration is changing the regulations on

pollution, and it says in there that the mercury is a threat to public health, to all public health, especially for children and mothers, but that means it's a threat to everybody else, too.

So, the message gets out that mercury is bad and you shouldn't eat fish. That is for everyone. In fact, all of us who didn't eat fish last night were part of that group.

The second group that I want to identify is my own constituency, the Pacific Islanders and Asians that are present in Hawaii. For Pacific Islanders, fish is it, there is no chicken, there is no meat.

I spent a month in Micronesia and tuna is it, it is the only meat source available, and we need to look at that group, as well as Native Americans, as a potential message that has to be delivered.

The third point is, is there some way

for--and I know this isn't a policy meeting--that industry or food stores or restaurants can be involved in this, or if they should, because that

is always a question, of identifying the low mercury fish for their public, because when you eat in a cafeteria line, you don't know what the fish is, but I don't know how that message can be set up and that is not the topic of this meeting, but certainly there will be industry people who follow up on that and identify the low mercury fish for us hopefully.

MR. PENDERGAST: If I could add something to your last thought, that is somewhat the thoughts that we had on implementation is how do you get the message out and where do you get the message out.

Some of our thoughts include working with grocery retail chains, working with restaurants, and even working within our own agency and what we serve our senior executives at their annual dinner, they had a choice between--was it steak and swordfish on there--so we have a lot to do in terms of how do we get the message out.

In this case, it is caterers, and those are the things that we will be looking at and considering as we do the implementation step.

DR. DOWNER: How many people chose the swordfish?

[Laughter.]

DR. ACHESON: Can I just respond to the issue of subpopulations? I don't think you can answer your question about swordfish, maybe no data.

One of the things that we recognize is that we are striving to develop a national advisory. The studies out of NHANES and CDC have told us on '99 to 2000 that 7.8 percent of the population had mercury above the RfD.

One of our goals at FDA, working with EPA, is to better identify who these people are. The NHANES data isn't powerful enough to give us a really good insight as to who these people are, what they are consuming, what their habits are. Some of them who are above the RfD profess not to eat fish at all, so we are dealing with other things, as well.

As we move forward on this, one of our goals at FDA is to develop programs to better

identify who this susceptible population is ethnically, et cetera, geographically, so that we can develop targeted advice.

This is a theme that has come up from a number of the committee members of should we target some people more than others, and it is our intent to try to develop those data, so that we can move in that direction, but frankly, we are not there yet, but it is one of our goals.

DR. MILLER: Did you want to make an announcement about something, Johanna?

DR. DWYER: No, I wanted to ask a question.

I wondered if you could, Dr. Acheson, just what you were talking about with the percent above a certain level of mercury in the blood.

DR. ACHESON: I am referring there to the NHANES work.

DR. DWYER: What is the variability there, is there just one measure of serum or blood mercury that they have?

DR. ACHESON: I believe so, one measure

per person, I believe that is what it is, but obviously, those data--

DR. DWYER: You could only get cells, right? You can get like age, sex cells or something?

DR. ACHESON: You can get broadbrush strokes on did you eat fish in the last 30 days, but we are not getting information on what kind of fish was that, do you eat sports-caught fish.

DR. DWYER: Are you revising those questions, those items for the 2005 survey?

DR. ACHESON: Yes. That is part of where we want to go, but that is not going to give us answers until 2007 or 2008. I am a little more anxious than that.

DR. APOSHIAN: There are people in the audience that can answer Dr. Dwyer's question as to how many blood samples were taken, there are people that were involved in that study in the audience.

DR. MILLER: Why don't we have a break and then we will come back to the discussion. I think the discussion here indicates exactly how complex

the situation is. That is what I heard not only from members of the committee that the advisory is too complicated, that it is not complicated enough even from the same person.

I might point out to Johanna that the debates over the Ten Commandments have continued and maybe it's too simple.

DR. DWYER: Thank you, Dr. Miller.

DR. MILLER: We will come back in about 10 minutes.

[Break.]

DR. MILLER: Unless there are some vital issues that members of the committee want to raise to the presenters, I would like to move on to the public comment section of the discussion on methylmercury.

DR. ACHOLONU: I have a comment to make.

DR. MILLER: Yes, of course.

DR. ACHOLONU: Thank you, sir.

I am compelled to make a comment about this. I looked through the list of mercury levels in various fish presented to us yesterday, and I

anxiously went through to see the fish called codfish, c-o-d, codfish, and I didn't see it here.

This is a sort of a follow-up question or comment to Dr. Waslien's, who comes from Hawaii. This fish is eaten a lot by people from the Caribbean Islands and people from Africa, and as a matter of fact, this fish is being shipped from Norway, and many of the Africans here eat it almost every day, and I find that it is not on the list.

I am concerned about it. Could we be told if any examination has been made of this to find out if it has a high level of methylmercury, because not too long ago, in Houston, Texas, some people ate this and it caused some death, and which I know.

Forgive me for bringing this into discussion. I would like this to be addressed, where does codfish stand with respect to mercury level content.

DR. MILLER: David.

DR. ACHESON: Yes, Dr. Miller, with pleasure.

Again, to reiterate, the data that I presented yesterday and the new data versus the old data is a subset of the total information that we have in our possession.

That table was constructed to compare the recent assignment of the 12 fish with the old data on those same 12 fish. We have a lot of data on other fish that are not in that list of 12 including codfish.

I refer you to the latter part of your folders where there is a copy of the exposure assessment, which actually on Table 2, I believe, lists a lot of the other fish data that we have. I just took a quick look at it. I think the mean mercury level on codfish was 0.143.

So, please don't assume that that list of 12 is all that we have data on. Hopefully, I made that clear yesterday, but obviously, failed to do so. We have a lot more data and we use it.

DR. ACHOLONU: I used the word "codfish." It is called stockfish, s-t-o-c-k, stockfish. Some people say that stockfish may be a kind of codfish,

it is really not codfish, called stockfish.

Also, we have this codfish that is salted fish eaten by the Caribbean people. They have what they call aki, salted fish, and it's a form of this stockfish, so you may want to find out if stockfish is the same as codfish.

DR. ACHESON: We would have to look into that as to exactly what stockfish is. We will have to ask a fish expert.

DR. MILLER: This is one of the big problems with this, that not only are there different names for the same fish in different areas, but even there are different fish that have the same name. Halibut in one part of the world is not the same fish as halibut in another part of the world.

It is really an incredible task, and I think that compromises are going to have to be made between the complexity of precision and the ability to make these things understanding for the bulk of the population we want to reach.

Public Comments

We now turn to the public comment part of this meeting having to do with methylmercury. Before we do, there are a couple of administrative issues.

First, I have been asked to read the statement which you have heard before in other areas of discussion, but in order to get it in the record and to remind each of the speakers that they have to fulfill the transparency requirements of our rules for this committee

Both the Food and Drug Administration and the public believe in a transparent process for information gathering and decisionmaking. To ensure such transparency at the open public hearing session of the Advisory Committee meeting, FDA believes that it is important to understand the context of an individual's presentation.

For this reason, FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement to advise the committee of any financial relationship that you may have with the sponsor, its product, and its

known direct competitors.

For example, the financial information may include the sponsor's payment of your travel, lodging, or other expenses in connection with your attendance at this meeting.

Likewise, FDA encourages you at the beginning of your statement to advise the committee if you do not have any such financial relationships. If you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking, but I encourage you to do so.

The second issue is to remind you that we have a very tight time schedule and we are going to stick to the time required. Most of the speakers have five minutes. A few have asked for and we have decided to allow them to have eight minutes, but whatever the time that has been assigned, please keep to your time, so that we can finish this up. The committee has a long discussion ahead of it afterwards.

Also, I would ask the committee to try and

keep your questions for these public speakers short and to the point of the discussion rather than trying to bring up other issues that we have already discussed or we will discuss later on.

The first speaker is Susan West Marmagas.

MS. MARMAGAS: Good morning. My name is Susan West Marmagas and I am the Environment and Health Director with Physicians for Social Responsibility.

In keeping with the request of the Chair, I have no, and our organization has no, financial relationship with the sponsor of this meeting or the advisory.

It is a pleasure to be with you this morning. Physicians for Social Responsibility is a national organization representing over 28,000 physicians, other health providers, and concerned citizens.

We work really on two fronts. One is we involve and educate the medical profession about a whole set of issues related to environmental health, of which mercury in fish is one, and we

also are involved in protective, precautionary public health policy work at the state and national level, and it is really from that perspective that I speak to this committee this morning.

We appreciate the opportunity to express our views. We were involved in the stakeholder meeting in July with FDA and EPA and have been closely following this issue because it is such an important public health issue and it is so important for clinicians. I am going to speak a little bit about the role of the clinician and the importance of advice for them as I get further into my comments.

We, however, are deeply concerned about the advisory that is put forward this morning to you to consider. We think that it's the status quo that FDA has put forward and it really gives false assurance to the American people that this issue of fish--we think it is false assurance on what is really safe in fish.

Therefore, I am going to speak briefly on six concerns, criticisms, recommendations of this

advisory and provide some guidance to you as a committee about how you might address those concerns.

The first, and we heard a little bit about that this morning, is the issue of science. We know that a credible and health protective fish advisory must have a foundation in public health science.

In the case of methylmercury, any advisory must be based on the EPA RfD, and we know that that is 0.1 micrograms per kilogram of body weight per day. As you know, the National Academy of Sciences endorsed this RfD in its 2000 report, calling it "scientifically appropriate level for the protection of public health."

In recent months, FDA has indicated that it will adopt and rely on the EPA RfD. However, the RfD is clearly not reflected in the draft fish consumption advisories before this committee.

We are concerned and baffled why the RfD is not being followed in this case and being met, and even yesterday, Dr. Carrington, in speaking to

this committee, acknowledged that the exposure assessment clearly indicates that the only way to ensure that 98 percent or more of the population remains below the RfD is to limit consumption to 6 ounces of a variety of fish--this is minus the high risk fish--or to limit consumption to 12 ounces of the low variety fish.

So, therefore, we don't understand why this RfD is not being followed. We think it is both misleading and irresponsible of FDA not to follow and meet the RfD and we urge this committee that the FDA should do that in this advisory.

The second area I want to talk about is children. In this new advisory, parents are urged vaguely to feed their children portions that are smaller than the 12 ounce recommended amount. What is "smaller"? We need to actually and I think we are able to think about how children are not just little adults and to model what is actually safe for children. We do this in other areas of child protective policy, let's do it with fish.

Why has the agency not consulted with

pediatricians, the American Academy of Pediatric experts who know how to model to protect children, and we would encourage that the FDA do that, because we believe that you can develop a formula for children's consumption that begins with the reference dose and accounts for the child's body weight and age and their neurological development.

You might look at a life stage approach, and we would encourage the FDA, we encourage you to consider asking FDA to do this, so that we can give more specific guidance to parents on protecting children.

The third area I want to address is tuna. Here, we believe very strongly that while the advisories note that canned albacore tuna is higher in mercury than canned light tuna, they are unexpectedly soft on this point. In fact, FDA's own new testing of methylmercury levels in canned tuna shows that albacore may contain up to three times as much mercury as light tuna.

FDA must make this distinction clear to the American public. In addition, there is no

clear guidance on canned tuna consumption. Eleven states now advise pregnant women and children to limit their consumption of canned tuna. We need to now do this at the national level. We need to provide federal guidance on the issue of tuna.

The fourth issue, and I think the one nearest and dearest to the heart of my organization that represents clinicians, is that we are very concerned that there is conflicting and unclear advice, medical advice on how to deal with this issue.

The advisory needs to clarify the potential effects. It equates so-called "minor delays" with medical condition, but it doesn't clearly talk about what that link is, so these

so-called minor delays that we believe are serious are sort of equated with medical problem. There is a distinction that needs to be made in this advisory.

In addition, the advisory assumes that health care professionals are prepared and ready to answer questions from their patients. It talks in

this document about if you think you have been exposed to mercury, immediately seek advice from a health care provider.

We believe that in order to avoid unnecessary concern from parents and to prepare health providers to really be part of the solution, that FDA needs to develop tailored and substantive guidance for clinicians.

We recommend that FDA reconsider the following statement, "If you have questions or think you have been exposed to methylmercury, see your doctor or health care provider immediately."

We question this message for several reasons. First, the advisory has previously implied that everyone is exposed to some level of mercury since it is ubiquitous in our environment, so are we now saying that everybody should seek medical advice? We need to clarify that point.

Second, health care providers are not prepared to answer questions from their patients without clinical guidance from EPA, and we believe it is incumbent to provide clinicians with more

details on what they should offer to their patients.

Finally, I want to conclude on my last fifth and sixth points, and we have heard this earlier today, we need to give an empowering message to the public and therefore, we need to talk about the low-level mercury fish. That information is not in here, and that is a great opportunity to say avoid these, these are where you can focus your attention. We think it is very important to highlight the low-level fish in this advisory.

Finally, and I think this is very important, in one of the initial drafts of the advisory, there was a statement that said, "There is no harm in eating more than the recommended amount of fish and shellfish in one week as long as you do not do it on a regular basis."

This doesn't work for pregnant women and we strongly recommend that in here, it says, "Pregnant women should be advised to follow the guidelines at all times, that at all times during

pregnancy, they should reduce their exposure to fish that are high and moderately high in mercury."

DR. MILLER: Ms. Marmagas, your time is up.

MS. MARMAGAS: Thank you.

We need to protect children and the fetus in their vulnerable windows of vulnerability and therefore all pregnant women throughout all of pregnancy should follow these guidelines.

I thank you for your time.

DR. MILLER: Any questions that need to be asked?

If not, we will go to the next speaker, Dr. David Wallinga. You have eight minutes.

DR. WALLINGA: I am Dr. David Wallinga. I am a physician with the Institute for Agriculture and Trade Policy in Minneapolis, Minnesota.

Thank you very much to the committee for allowing me to speak. As with the previous speaker, my organization has no financial relationships with the sponsor of this meeting.

I speak with many different hats including

having carried out training around how physicians can give advice on fish consumption to almost 1,000 health professionals over the last couple of years.

I also come with the hat of having helped prepare this consumer advice that we distributed to you, which is Minnesota-specific, but I think it has some interesting lessons, and then, thirdly, as a resident of Minnesota, which I believe has the most fish advisories of any state, most of those being for lakes, which are not mentioned in the advisory, by the way.

Also, somebody had raised the issue of the states having to distribute advisory information. Minnesota prepares advisories, but its $35,000 a year budget for actually distributing it was cut.

So, I wanted to applaud the committee and FDA for a couple of things, first, renewing their testing program and generating more comprehensive data, and also for trying to work jointly with EPA to come up with a single piece of advice.

But I did have several concerns that are going to be echoing those of the previous speaker.

As a physician, primarily, I want to point out some ways in which this advisory may make it harder for physicians to practice in a way that is consistent with their oath to do no harm.

First of all, relative to serving sizes, I agree that the draft advisory is confusing on this score, and I wanted to just talk a little bit about Dr. Jane Hightower's data. She gave me permission to use some of this information, and she did this study that you are familiar with, looking at 123 patients of hers from a practice that sees about 700 patients a year.

The patients in that sample had a number of fish meals that ranged from 3 1/2 to about 50 per month with an average being 18 per month or 4 per week, and they considered a serving size to be between 5 and 8 ounces. Many of the restaurants they frequented served fish servings in that amount. So, I really think that this 12 ounces, whether it is 2 or 3 servings, it should reflect real life.

I also noted the inconsistency between the

serving size for the 12 ounces of seafood and the 6 ounces of freshwater fish, and that should be addressed.

Second, I wanted to point what I did in this chart was to start again with the reference dose of 0.1 microgram per kilogram per day for a 60 kilogram woman, equates with a 180 micrograms of mercury ingested per month, and I compared that to what the ingestion would be with fairly modest 6 ounce servings of these species, which is not as much as up to 12 ounces that is recommended, but is consistent with the advice to only eat one species a single time per week.

As you see for grouper, orange roughy, Minnesota walleye, canned albacore, and for those species, they all exceed the reference dose amounts. In addition, just for yuks, for halibut, I looked at what would happen if you ate it eight times per month or, alternatively, a one-pound serving, and again you are over.

As you can see, there is this disconnect between the reference dose and the advice that is

actually given. I think the Environmental Working Group is going to talk about this later, but I wanted to just point that out.

Patients don't eat fish based on just mercury, they want to know which fish are safe to eat, and they also want to, as was mentioned earlier, they see things holistically. I don't think this is too surprising. They want to know the totality of the fish that they can eat. Although the draft advisory mentions freshwater species, there is not much concrete advice about freshwater species.

We attempted to do that in this report. We had combined information from both FDA, as well as state information data on PCB and mercury contamination for Minnesota fish.

We did some others things, too. We had an expanded Do Not Eat list reflecting our belief that a 0.5 parts per million cutoff in terms of what people should have, and because many of the species that have been most recently tested by FDA have elevated levels above 0.5, we think that the draft

advisory should have an expanded Do Not Eat list, but I would also point out that in Minnesota, PCB contamination including many of the low mercury species can result in fish advisories, and we should say something about predatory fish that are freshwater fish, like muskies, white bass, large walleye, and large pike.

That didn't prevent us from starting off telling people what they can eat, and I think this is a very key point, that people are not confused or scared because of too much information, rather a lack of specific information, and we tried to empower consumers to find fish that are safe that they can eat.

We added in some sustainability criteria that I don't think I will talk about, but that is what some of the coloring has to do with.

Second of all or another point is that our advisory seeks to protect everybody, and I know you are familiar with this graph. This is from EPA's Children's Report, just depicts the CDC data, and so that is what a lot of us have been talking

about, but obviously, the advice doesn't protect wealthier people who tend to be high-end consumers of fish, and maybe that can't be covered in this advisory, but perhaps this committee should recommend another advisory.

It also doesn't reflect concerns for adults who don't plan on getting pregnant, namely, concerns for their cardiac health and people with cardiac disease.

This is just to say, again data from Jane Hightower's study showing that a large percentage of the people that she looked at, and did mercury sampling for, had blood lead levels that exceeded, in some cases many fold, the maximum recommended blood mercury levels, and their hair levels were also elevated in some cases.

What is this talk about cardiac toxicity, because again the advisory doesn't mention this at all. The literature about the cardioprotective effects of omega-3 fats is pretty good, but as the NAS also pointed out, there is much data from both animals and humans that exposure to methylmercury

can have adverse effects on the developing and adult cardiovascular systems and that some research suggests that these adverse effects occur below levels associated with neurodevelopmental deficits.

Here is again some other studies that they have talked about pointing out that just a 2-fold increase--

DR. MILLER: Dr. Wallinga, could you summarize, please.

DR. WALLINGA: Yes. Let me just skip to the end. So, suggested changes - serving sizes should reflect real life, that in the upper limit of recommended fish consumption should be safe. We should empower patients by telling them what fish they can eat and don't insult the intelligence of the patients by assuming that it is more than they can handle.

We should do more testing of fish that people can eat, and we should also test for pollutants other than mercury. Right now I have trouble finding any PCB or dioxin or flame retardant testing for fish in the FDA website.

Finally, perhaps we need a separate advisory dealing with cardiac endpoints, so that, as a physician, we can give good advice to all our patients, and not just those expecting to get pregnant.

Thank you.

DR. MILLER: Any brief comments? Thank you.

The next speaker, five minutes, is Caroline Smith DeWaal.

MS. DeWAAL: Good morning. I have no financial ties with the sponsors of this meeting.

I am Caroline Smith DeWaal and I represent 800,000 consumers who are members of CSPI and subscribers to Nutrition Action Health Letter.

We actually put out consumer education to consumers 10 times a year on foods that they may want to purchase were very specific, and we have a lot of good advice, both for nutrition and also for food safety.

We have been very supportive of this process and we appreciate the work that EPA and FDA

have done to date. Just bringing the agencies together and agreeing on common language is progress.

However, we are disappointed with the final consumer advisory, which I didn't see until yesterday morning, and in my remarks which are included in this paper, we talk about three draft advisories, which is what we saw prior to this meeting.

Let me give you just one example of our concern regarding this advisory. I am going to read the risk message.

"The FDA and the EPA are advising pregnant women and nursing mothers to eat the types and amounts of fish and shellfish that are safe to prevent any harm to the developing nervous system of their baby or young children."

That may mean something to other people, but I can tell you it doesn't mean a lot to me, and I think it doesn't mean a lot to the consumers that we are trying to communicate to. I think it is a double positive to communicate a warning message

and it really doesn't work.

In addition, I think one example that shows perhaps the way we got to that kind of message as being a risk message, which it isn't, may be in some misunderstandings of the people drafting it.

For example, Dr. Acheson was quoted in the Washington Post this morning, saying that the advisory was implicit in telling at-risk women to eat more than 4 to 6 ounces of tuna per week.

I mean in a consumer advisory, we cannot be implicit, we cannot have implicit messages. If that is an important message to at-risk women, it needs to be explicit.

I have a couple of pieces of advice. We believe that the advisory needs significant redrafting in order to be effective, and I hope that the Food Advisory Committee can make some recommendations that will help get this advisory out quickly, but in a form that is much more effective.

First of all, we would urge you to

recommend to Commissioner McClellan that he convene a roundtable of experts from consumers, public health organizations, and the seafood industry early next year to make recommendations on the advisory.

You might want to think about this as a stakeholder focus group. They are doing focus groups with average consumers. Perhaps they should do one with stakeholders and get very specific ideas for making improvements.

Frankly, I think we could--I have been working on this issue since 1991 when the National Academy of Sciences first criticized FDA's standard for methylmercury--I think that I could sit down with members of the seafood industry and come up with a clearer, shorter, and more effective message.

I think you also might want to recommend that they think about more than one advisory. There is the advisory to pregnant women, but there should be a separate advisory to the parents of young children.

Children eat--anyone who has children knows this--if a child likes a food, they eat it all the time. If they like tuna, they are going to want tuna five days a week. We need to be very explicit with consumers, and in CSPI's Nutrition Action Health Letters, we actually published a list that has the weights of children and how much is safe to eat for canned tunafish.

Again, these numbers need to be redone on the basis of the new data that FDA has developed, but giving parents very specific information about what is safe to eat I think is quite important.

My third recommendation to the Advisory Committee is to ensure that the final advisory reflects the science. We heard yesterday from Dr. Carrington in the exposure assessment that really, the 12 ounces recommendation only goes to the seafood that contains low amounts of mercury, and not to many of the fish that are on the list.

The better recommendation may be 6 ounces of seafood, not 12 ounces. In addition, the names of the fish aren't clear. My understanding is

tilefish is actually frequently sold as golden snapper. So, getting the actual correct names of the fish in the advisory is very important.

Again, I think a focus group of experts from the seafood industry and consumer communities might be able to work out some of these issues if it can't be done at FDA.

DR. MILLER: Caroline, can you finish up, please.

MS. DeWAAL: I can. finally, we would like to bring to the committee's attention another advisory which is in use in California. This is in your packet. I would urge every member of the committee to look at it.

This is actually at point of purchase when you buy seafood in California, and it mentions salmon, shrimp, and scallops as the low risk seafood, the things that people can eat a lot of very safely, but this has a lot of good information and the information that the Advisory Committee has been asking for. So, if you look at this in our packet, this will I think also give you some ideas

of how to do the advisory more effectively.

Thank you very much.

DR. MILLER: Thank you, Caroline.

Any questions for her? Thank you.

The next speaker is Carol Stroebel from Children's Environmental Health Network. Five minutes.

MS. STROEBEL: Thank you. Thank you for this opportunity. My name is Carol Stroebel and I am representing the Children's Environmental Health Network, and although I am not a scientist myself, I am honored to be working with the nation's foremost researchers and clinicians in the field of children's environmental health through their participation in the Network.

In terms of financial disclosure, my sole relevant financial relationship is the compensation I receive from the Network from the work I do for the Network.

The Network was created to promote the incorporation of basic pediatric principles in policy and practice. My written statement includes

these principles in detail, but I will summarize them now simply by urging you to always keep in mind that children have unique vulnerabilities, susceptibilities, and exposure.

We have learned from sad experience that exposures to environmental toxicants that result in little or no harm to adults can lead to lifelong harm in children. The Network strongly urges you to help assure that these principles are applied in all FDA actions and policies, especially those that relate to methylmercury.

We know that methylmercury is a potent developmental neurotoxicant. Thousands of U.S. children are estimated to be at risk from exposure to mercury, an estimated 60,000 infants each year from in-utero exposure alone. We have a responsibility to prevent these risks, and the FDA has a substantial responsibility in this regard.

Certainly, what FDA and EPA and other government agencies communicate to the public is vital, and I will speak on that momentarily, but these decisions must also be made in the context of

two paramount issues.

One is that standards that are not adequately health-protective of children will place children at risk. Dietary advice, while vital, is, by itself, inadequate to eliminating the risk of methylmercury, and prevention of risk begins with a better understanding of the sources and levels of exposure. We cannot successfully undertake the task of keeping mercury out of our food chain if we do not monitor our foods for the presence of mercury.

Thus, the Network strongly urges the FDA to adopt and enforce the NAS/EPA standard for the safety of methylmercury in fish. We have been heartened by the recent joint EPA and FDA discussions on mercury and we are hopeful that they will result in coordinated and health-protective standards for children.

We commend the FDA for undertaking some increased monitoring of mercury levels in fish. However, we need to undertake a systematic monitoring of mercury in fish and in people, as

part of a coordinated governmental effort to protect people from the harmful effects of mercury.

In addition, other foods with known or potential mercury contamination must also be tracked and analyzed, so I want to take the opportunity today to mention another issue I hope that the committee considers.

There is a recent analysis of baby foods by government agencies in the United Kingdom and it found a quarter of the samples contained mercury and that the average level of mercury in those foods was double that found three years earlier, and some babies were found to be consuming twice the amount that the U.S. EPA would deem safe for adults.

The Network communicated to the FDA earlier this year and asking for them to undertake an analysis of baby foods. Unfortunately, the Network has yet to receive a response, so we request that you consider recommending that FDA also monitor these foods for mercury.

In terms of the consumer advisories, our

written comments also refer to the three draft advisories, not to the fourth version that we just saw this morning.

The Network commends the FDA for the efforts it has undertaken to improve its consumption advisories, and we thank the Advisory Committee for the great leadership it has shown on these efforts.

We wish to associate ourselves with the testimony and the materials developed by Consumers Union and by Physicians for Social Responsibility, and we urge the committee to carefully consider their proposals.

In brief, we urge that all consumer advisories on methylmercury in fish and seafood reflect the following concepts:

First of all, the advisories must be based in science; they should define what science indicates is a "safe" dose and provide advice that would keep consumers from exceeding the RfD. None of the draft advisories do so.

The advisories should assure that all

subpopulations at risk are targeted. Certainly, women of childbearing age must be targeted. But so must other groups at risk, particularly children. The draft advisory does not focus on children and is not specific enough for children. The draft advisory title, for example, says advice for women of a certain group about children.

Children can safety consume far less fish than adults, and the advisories must clearly make this point, and advisories must make clear that even one-time high-end consumption - a spike in mercury exposure - could be harmful to children.

Some advisories have mentioned a specific number of ounces that would be okay for adult consumption, but then used vague term, such as "smaller" when providing guidance related to children.

DR. MILLER: Ms. Stroebel, could you summarize.

MS. STROEBEL: Sure. The advisories should provide more information about different fish and seafood varieties, so that consumers are

not given the impression that all species off the Do Not Eat list are equal, and the advisories should put health first even if it means a message to eat less tuna rather than a misguided statement that you can safely include tuna as part of your weekly fish consumption, which is not the case clearly for some part of the population.

Thank you very much.

DR. MILLER: Thank you.

Yes.

DR. APOSHIAN: I think your statement of 60,000 children at risk is extremely conservative. We have been all handed a copy of a peer-reviewed paper from the EPA group co-authored by Mahaffey, Clickner, and Joseph.

In the summary on page 4, and I will just read the statement, "Based on the distribution of blood mercury concentration among the adult female participants in 1999-2000 NHANES and the number of U.S. bursts in 2000, more than 300,000 newborns each year in the United States have been exposed in-utero to methylmercury concentrations higher

than those considered to be without increased risk of adverse neurodevelopment effects associated with methylmercury exposure."

The article, peer-reviewed journal by the EPA, that I think should not be ignored.

DR. MILLER: Thank you.

The next speaker is Robert Califf [ph] from the National Fisheries Institute.

MR. CALIFF: Good morning. I would like to thank the Food and Drug Administration and the Environmental Protection Agency for the opportunity to address the Food Advisory Committee this morning.

I represent the National Fisheries Institute, an Arlington, Virginia based nonprofit trade association representing the commercial fish and seafood industry, and we have no financial connection with the sponsors.

NFI wishes to commend the Food Advisory Committee for its recommendations provided to FDA at the conclusion of the committee's meeting in July 2002. We also wish to acknowledge the work

undertaken by FDA in response to the recommendations and the efforts by both agencies to develop a joint advisory for mercury and fish.

In 2002, NFI made a presentation to the Advisory Committee with the assistance of Dr. William Connor of the Oregon Health and Science University. Dr. Connor provided a review of the scientific literature that shows the positive influence that fish and seafood has on nutrition and health status of U.S. consumers.

Dr. Connor's review included the large body of scientific research on the cardioprotective effects of N3 fatty acids found in fish and the essentiality of N3 fatty acids in the development of the brain and retina during fetal growth and in babies after birth.

In addition to this body of research, new information is emerging on N3 deficiencies and depression. In 2001, a paper was published in the Lancet by NIH researcher Dr. Joe Hiblin [ph], who observed that mothers transfer DHA to their fetuses to support neurological development during

pregnancy, and further concluded that mothers without sufficient intake can become depleted of DHA, which may increase their risk of suffering major depressive symptoms in the postpartum period.

I have begun my comments by mentioning this information to make the point that fish is not like tobacco or alcoholic beverages that carry risks with little or no health benefits to those who use them.

We believe the benefits of fish consumption must be highlighted in explaining the mercury issue. Advisories should be educational messages that are easily understood and balanced regarding the risks and benefits associated with fish consumption.

If they are not, we believe consumers will be confused, causing them to deselect fish from their diet. This would be unfortunate and perhaps harmful to consumers because they would lose the health benefits associated with fish consumption.

There is some evidence that the release of the existing fish advisory and media coverage

surrounding that release has already resulted in the decrease of consumption amongst pregnant women.

Dr. Emily Oken of Howard Medical School and colleagues published a paper this year that showed an association between the release of the advisory and reduced consumption of tuna, dark meat fish and white meat fish alike in a cohort of 2235 pregnant women in Massachusetts.

The authors concluded that the public health implications of these changes in consumption remain unclear because fish may confer nutritional benefits to mothers and infants.

The study suggests to me that women may not understand the dietary changes may not be needed if they are already avoiding fish with the highest levels of methylmercury and are eating a variety of fish on average in the amounts recommended.

There has been considerable discussion about whether the existing advisory goes far enough in warning women of childbearing years about methylmercury and making recommendations about fish

to avoid.

I think some context can be provided by looking at what some of the other developed nations around the world have done. In Canada, the recommended limit for swordfish, shark, fresh and frozen tuna is one meal per month for young children and women of childbearing age. The Canadian advisory notes that this restriction does not apply to canned tuna.

In Australia and New Zealand, the current advice for pregnant women is to limit the consumption of shark, swordfish, and six other species to four portions per week. It also indicates that other fish, including canned tuna, can be consumed as often as desired, but consumers should eat a variety of fish.

The health agencies in Australia and New Zealand have said that they are reviewing this advisory in part due to the establishment of a new WHO tolerable weekly intake that is intended to protect the developing fetus. The WHO's tolerable exposure level is a little more than double EPA's

RFP.

In June of this year, a news article in Japan indicated that the Japanese Ministry was advising pregnant women not to eat swordfish and alfonsen [ph] more than two times a week and to limit consumption of shark and sperm whale to no more than once a week.

Interestingly, the article indicates that the Ministry said the consumption of fish does not pose a health problem to pregnant women, but despite that effort by the Ministry, the message conveyed to consumers resulted in a drop in the sale and price of alfonsen sharply.

DR. MILLER: Could you summarize, please.

MR. CALIFF: Thank you.

In regard to the advisory itself, we would like to first commend the agencies on the work they have done to develop the joint advisory, to test it, and then to rework it based on focus group responses.

We ask that agencies ensure the advisory provides adequate reassurance to consumers that

fish is a healthy food choice that should be maintained in the diet. Finally, we urge the agencies to continue the careful process they have begun by testing the version of the advisory that they propose to use including the evaluation of the impacts of the advisory after it has been issued.

Thank you for your time.

DR. MILLER: Any questions or comments? Thank you.

The next speaker is Dr. Ned Groth from Consumers Union. Eight minutes.

DR. GROTH: Thank you very much, Mr. Chairman.

Consumers Union is a not-for-profit testing and publishing organization supported by subscribers, of which we have about 5 1/2 million.

For those of you who don't know me, I am a biologist. My specialty is environmental health. I have been at CU for 24 years doing risk analysis, risk assessments, scientific research, and policy advocacy and risk communication on food safety and environmental health issues. In fact, I have been

dealing with issues like this since Sandy was the head of the Bureau of Foods.

We have a considerable amount of experience to share with you. I have distributed a written statement. I am going to highlight some key elements of that in the context of what I hope this committee can do today to help move this process forward.

We think the FDA and EPA have come a long way, but there is still a lot of improvement needed in three particular areas I want to call to your attention and hope you will concur with.

One is the advisory has to be based on sound science in terms of defining what is a safe intake. As we have heard in many ways, it is not at this point. It simply cannot say that it is okay to eat more fish that contains mercury that will give doses above the reference dose and call that safe.

The reference dose is a definition of safety in that it means exposure below that is reasonably certain to pose no risk of harm, but

above that, it is not certain it is harmful, it is just we are in the gray zone between knowing there is no risk with scientific reasonable certainty and knowing there is a risk.

The gray zone is only a factor of 10Y in this case. It is not a huge safety factor. So, if you are talking about exposure that could be 3 or 4 or 5 times above the RfD, which could happen with some of the fish meals that people are likely to be eating, we are way too close to the level where we know harm is likely, and we have to stick to a reasonably scientific and well-vetted definition of safety.

The FDA has adopted the RfD, but it isn't reflected in this advice, and it has to be. So, I think that is point 1.

Point 2 is about populations at risk and several people have already addressed that. I endorse what Carol Stroebel and David Wallinga and others have said about targeting advice to other groups we know are at risk, not merely pregnant women. Children as a separate group, yes; high-end

fish eaters, I want to say some more about that.

I have looked at the data on fish consumption from figure 2 of the Carrington and Bolger paper, and tried to read that graph. Right around the inflection point is where it gets interesting, but it appears that about 2 1/2 percent of the population consume more than 0.6 fish meals a day, which would be 4 fish meals a week, and if you go down to 0.5, it is about 5 percent of the population consumes half a fish meal a day or more, which would be 3 1/2 fish meals a week.

When we consider portion size, which I will, I think it is reasonable to assume that those people are eating more than 12 ounces of fish a week. That means if we are talking about the population of the United States, 2 1/2 percent is about 7 million people, 5 percent would be 14 million people. Not all of the people in the United States eat fish, but it is still a very large number of people we are talking about who eat more than, and can be reasonably expected to eat

more than, 12 ounces of fish a week.

I can just say anecdotally I have eaten more than 12 ounces of fish in a meal. If you go to Legal Seafood, at the prices they charge, and have a shrimp cocktail and a plate of scallops, you are getting 20 ounces of seafood by my conservative estimate in one meal, and that is not unusual especially as someone mentioned, for wealthier consumers.

There is an article in the Consumer Reports issue that is out now which talks about the obesity problem, and one of the factors in obesity is portion size, and one of the things we have learned about portion size is that people take home from restaurants a subjective impression of what is an appropriate portion size.

So, people are now serving much larger servings of meals at home because they get them in restaurants, and people are eating more, consuming more calories than was true a decade ago.

I think the last point I want to make is about the message, and I think this is the area

where the advisory needs the most work. I found it very confusing, I found it scientifically incorrect, and I found it, in many cases, self-contradictory.

I think the message is it follows in an FDA tradition of what I call the warning label approach, which is if something is dangerous, you want to tell people not to eat it. That leads to a false dichotomy.

If it is not dangerous enough to require a warning label, it must be safe, and that is not the case. Risk is a continuum and to single out four very high mercury fish and then say in several ways, and everything else is okay if you moderate your intake, I think is misleading and wrong.

We have also learned at Consumers Union that what people want more than anything else is tell me what to buy, what should I be eating. Telling me what not to buy is one part of the information, but what people want most is to know what to buy.

If you look at Table 2 in the handout, and

if you modify that, which I have done, but haven't done in that one, by including the updated FDA data that were released for this meeting, there are now about 15 varieties of fish and seafood, including a large number that are very widely consumed, like shrimp, scallops, and salmon, that are below 0.12 parts per million, which is the level of mercury at which, if you consume 12 ounces a week, you will just meet the RfD.

So, there are 15 low mercury choices, and if I were to rewrite this advisory at this point, and, like Caroline, I think I could do it pretty quickly, I would say, first, choose from this list of fish to keep your mercury within safe limits, and basically, you could say eat as much as you would like of these fish and you will be safe. That would be those with less than 0.12.

Then, I would say do not eat the four with the highest mercury, put the warning label in there, and with respect to everything else, I would say don't eat more than one portion a week. Eat a variety, but don't eat more than one portion a week

of any of those others because many of them are moderately high in mercury.

The one point I might modify in what I just said is FDA, in the Carrington and Bolger paper, has defined high and low and moderate mercury content. High is above 0.5. I might add to the Do Not Eat list those fish that have above 0.5. There would be three or four other things to add to the four that are already on that list.

I think also in terms of specific advice about tuna, it needs to be much clearer that albacore tuna and fresh tuna steaks are in the moderate, don't eat more than once a week, and eat only small portions of category.

I think light tuna fits into the low mercury category especially with the decimal point refined with the latest data it would be around 0.12, and that is fine, but you need to be much more specific and give clear advice about not eating too much albacore or fresh tuna steaks.

I think that is it, and I would be happy to answer any questions.

Thank you.

DR. MILLER: Thank you, Ned.

Any questions or comments? Thank you.

The next speaker is Michael Bender, Director of Mercury Policy Project. Eight minutes.

MR. BENDER: My name is Michael Bender. I am the Director of the Mercury Policy Project. We are a nonprofit, focused on reducing mercury emissions and exposure to mercury at the local, national, and global level.

We have no financial relationship with the sponsors. I appreciate the opportunity to be here. Like others, I just wanted to express my appreciation for FDA and EPA getting together and trying to put together a comprehensive advisory.

It is also good to see that FDA has gone out and done some canned tuna testing, some comprehensive testing for the first time in 10 years, and that sort of came on the heels of our testing of 60 cans of tuna in June of this year, and we are also glad to hear that they are planning on doing additional testing.

While this is difficult for people to read, and I apologize for this, everyone should have a copy of this in front of them, at least the committee members, and I decided to take a more pragmatic approach than my colleagues, and while I would second the recommendations to work with the stakeholders and to see if we can come together and to make some kind of a comprehensive approach that addresses the issues pragmatically, I wanted to make some suggested changes if you are presumably working off from this draft and trying to improve it.

The first thing I would suggest would be simplification, offer more specific consumption advice for children would be secondly. An approach to the use by the State of Washington, and I will show you a graph exactly what they do, and also, as other speakers have suggested, make your recommendation more consistent with the EPA's reference dose while promoting consumption of low mercury fish and shellfish.

I would reword the title, Advice for women

who are pregnant, might become pregnant, nursing mothers, and young children, about reducing mercury exposure from fish and shellfish consumption. Straightforward and to the point.

I don't have a problem with starting out with saying that fish is an important part of a balanced diet. I think it is important to continue to convey that message, but the first change would be the suggestion to eat low mercury fish and shellfish, I don't think this can be emphasized enough. That would be in the second clause of the handouts.

The second change would be, suggestion would be to add albacore tuna, and that would be both fresh and canned tuna, based on not only the FDA's data, but also our data, and other data from Consumers Union, the FDA data from 1992, et cetera.

That third change would be in No. 2, where there is a recommendation for 12 ounces a week. I would recommend that in lieu of any kind of list, that you change that to 6 ounces (one meal) per week of purchased fish and shellfish.

I would also, in my next suggested change, move from the Q and A, where we are for the first time ever addressing tuna in a question and answer, and I would argue that a lot of people won't get that far, that you need to have a sentence in No. 2 which, in a positive way, states that you can consume light canned tuna in moderate amounts or in moderation as part of your weekly consumption.

My next suggested change, and mentioned by Dr. Wallinga, was in the EPA part of the advisory where they talk about local streams and rivers at lakes and ponds. Most of the fish probably comes from lakes.

I guess for the children-specific section of the advisory, give examples. For example, a

20-pound toddler can eat 1 ounce of fish or shellfish per week, a 40-pound can eat 2 ounces of fish or shellfish per week, and an 80-pound child can eat 4 ounces of fish or shellfish per week.

I just will quickly go through--I just have two or three slides. This has been mentioned before. There are now 11 states that warn pregnant

women and, in some cases, young children, to limit consumption of canned tuna. These warnings started in 1997. Actually, there is another one, Hawaii is now added to the list.

Not only do they talk about limitations, but they also note starting in 2000 in Maine, that women of childbearing age limit to one can of white or two cans of white. There is a distinction that is being made. Again, that was based on the FDA dataset from 1992, a very robust dataset.

This is from the Washington State Health Department. It's right on their website. It basically talks about, it follows the EPA reference dose of body weight per kilogram per day, or I think it might be a little more stringent. The note I have here is that it is based on the FDA lumpage of 0.17 ppm, and not the new FDA data, the average mean of 0.358.

Just looking at the person's body weight at the bottom, that is where I derived the recommendation for the children. As you can see, for a 20-pound child, this would be less than 2

ounces; for an 80-pound child, it would be 4 ounces.

So, I think there is some information out there that is available on this.

Secondly, I just wanted to bring your attention to our canned tuna dataset. As I mentioned earlier, we released our results in June, and the average we found was about 0.5 ppm, a little bit higher than the FDA dataset.

The range was greater. It was from 0.23 to 1.1 ppm. I believe the last time this committee met, Dr. Aposhian had mentioned that he had tested 10 cans of tuna and found 1 over 1 part per million. The industry has also indicated that some of the canned tuna comes in over 1 part per million.

[Inaudible comment.]

MR. BENDER: I am sorry. Yes, the bottom is the light tuna and what we found--I am glad you mentioned that--the average for the 10 cans was 0.118, which is very consistent with the FDA's testing both this year and in their 1992 test.

It is difficult to read this one, as well, but basically, we just did some calculations if we were to apply the FDA's mean of 0.358 to the different body weight.

For instance, a 22-pound toddler eating only 2 ounces of tuna per week with the 0.358 ppm would exceed the EPA's RfD nearly 3 times; a 44-pound child consuming 1, 6-ounce can of tuna with 0.358 would exceed the RfD by over 4 times; an

88-pound child consuming 1, 6-ounce can of tuna with a 0.358 ppm would exceed the RfD by over 2 times.

A woman with a typical body weight of 132 pounds consuming 2 cans of tuna per week with 0.358 will exceed the EPA's RfD by almost 3 times. Also, if the same woman eats only 1, 6-ounce can with the same ppm, she will exceed the EPA's RfD by over

1 1/2 times.

DR. MILLER: Could you summarize.

MR. BENDER: Yes. So, in summary, I guess I would just reiterate many of the points of my colleagues, and if the committee was at a place

where they wanted to move forward now rather than suggest revisions for the future, I would suggest that they consider some of the points not only that I made, but of my colleagues.

Thank you.

DR. MILLER: Thank you.

Questions or comments? Thank you.

The next speaker for 5 minutes is Dr. Joanna Burger of Rutgers University.

DR. BOEHM: My name is actually Dr. Susan Boehm from the New York Academy of Sciences. I am speaking on behalf of Dr. Burger who could not be here for part of my remarks, and then I will speak for myself, as well.

Dr. Burger has no financial ties to either of the funders here.

I am talking specifically today about a paper that is in publication by Drs. Burger from Rutgers University and Dr. Gochfeld from the Robert Wood Johnson Medical School, where they looked at approximately 145 cans of tuna, white and light. I will present the highlights of that.

There are about 12 copies of this paper. It has been embargoed until publication, but she got permission to distribute it to the committee, and some of those have been distributed. Then, there is a summary page that is out on the table that summarizes the findings.

Of the 123 cans of albacore and 45 cans of chunk light tuna, they demonstrated there was a much higher mercury concentration in the albacore tuna, on the order of 3 1/2 times. This is very similar to what has been seen before.

They also did these analyses over a number of years, and there is evidence that there could be increases, that we could be increasing mercury concentrations over time in cans of tuna.

Also, there have been some spike years probably due to changes in fishing.

Approximately, 90 percent of the mercury that is in the tuna is in the form of methylmercury. That is important to always keep in mind. Twenty-five percent of the albacore tuna that they tested was over the 0.5 ppm level.

They recommend that persons who are frequently eating canned tuna could, in fact, choose light tuna over the white tuna if they were aware of these differences, and that systematic monitoring of the cans of tuna supplies should be established, that doing it once every 10 years is clearly not enough if we are, in fact, seeing increasing levels of over time, and that fish advisories should always distinguish between the two types of canned tuna.

They also measured about 9 cans of mackerel, canned mackerel, and found them to have low mercury concentrations, so that might be something that could be put as a positive thing, something that could be eaten.

That is the summary of Dr. Burger's comment.

I am now going to speak for myself from the New York Academy of Sciences, and I will disclose that we do have--I work on a project, a large-scale, ongoing project, multi-funded, but one of our funders is EPA.

Our work, what we do is we track sources of mercury and methylmercury to the New York/New Jersey harbor, so we backtrack to every product process that releases or produces or uses mercury, trace how it is used, released, and produced through disposal, and look what is getting into the harbor, but the idea of figuring out ways to step in and keep mercury out of the harbor. That is the background of our work.

I wanted to sort of echo something that Dr. Dwyer pointed out, that this wording in the newest advisory really focuses, while it is very important to focus on women and children, the rest of the population has now been left out, that the rest of the population is not included or is not specifically included now in this document.

It is the responsibility of the FDA to provide the information to the consuming public, and it is very important that we target children and pregnant women about safe consumption habits and about light versus dark tuna, but also cover all populations.

Fish are well established as being a healthy source of protein. The FDA has an opportunity to give people positive choices for fish consumption, not just what should not be eaten.

From our work, I think really crucial is implementation, is how this is going to be implemented. The old approach of handouts and things like that or fish advisories on the web is not going to work. We know this from our own work as we try to implement some of our recommendations, you really have to target specific populations.

We know in the New York area, we have a lot of subsistence fishermen. We have recently learned that women in the WIC program, women with infant children are subsidizing their food by fishing in the East River, and this is a population that has been completely ignored.

Finally, I just wanted to mention in the advisory, in the statement on what is mercury, it notes mercury "occurs naturally in the environment and can also be released into the air."

Mercury is released into the air from industrial pollution. We don't need the word "can" there at all.

Also, in the New York/New Jersey region, the major source of mercury is not necessarily from the air to the harbor, it is through the wastewater treatment facilities and generally from dentists, hospitals, and laboratories. So, that statement isn't quite complete for the national picture.

That's it. Thank you.

DR. MILLER: Thank you.

Questions? Johanna.

DR. DWYER: Just a quick one. On the values that you were talking about, the samples that were analyzed, I was intrigued by Dr. Lund's suggestion yesterday that there was a way to try to find out geographically where high samples might come from, and wondered if you had done that, of if that group, or anybody else had done that.

DR. BOEHM: They have made note of where the cans of tuna indicated they were from, the countries, but that doesn't necessarily mean they

were caught near that country, because the fish can be moved to areas where it is easy to process, so there is not, in this report, they had no way to track where the fish were coming from.

DR. ALLER: Just a quick question, I just want to make sure I understood. For the second half of your remarks, were you speaking for yourself or for the National Academy?

DR. BOEHM: New York Academy of Sciences.

DR. ALLER: Thank you.

DR. ACHOLONU: You mention that mercury comes from dentists. Is that significant enough to be mentioned in the advisory?

DR. BOEHM: The mercury that you are seeing in fish, there is no way to tell where it is coming from, and in different places, it is going to have different sources. It is sort of a very separate issue from what is being discussed here, I would say.

DR. MILLER: The difference is, is the amalgam. It is direct exposure. Since our concern is entirely on what appears in the fish--

DR. BOEHM: We are talking about mercury that goes through a dental facility into the wastewater treatment facility and gets into the New York/New Jersey harbor, not the direct human, in your mouth, it is human contact. We are talking about what ends up in the harbor.

DR. MILLER: Right, and that is the source of mercury that contaminate fish would probably be relatively small.

DR. BOEHM: In fact, it is not because wastewater treatment facilities are great methylators. They have all the right conditions for methylating mercury, so it turns out to be a source of methylmercury to the harbor.

DR. MILLER: Thank you.

The next speaker is Jane Houlihan, Environmental Working Group.

MS. HOULIHAN: Good morning. I am Jane Houlihan, Vice President for Research, Environmental Working Group. We are a public health research organization based in Washington, D.C.

Just a point of clarification, Dr. Miller, I requested and was told I was granted 15 minutes. Is that what you understand?

DR. MILLER: That's right.

MS. HOULIHAN: I just want to cover two things briefly today. The first, is this advice protective? We think it's not and I will lay out some detailed calculations on why that is. I also want to talk about the adequacy of some of the fish testing data that underlies the exposure and risk models and that really forms a backbone of the consumer advisory.

For many, many species, adequate testing has not been done, and it gives this advisory a pretty weak scientific background for a lot of the popular fish that are consumed in the U.S.

First of all, I did just want to say congratulations to EPA and FDA. It's a big step forward to work together on this advisory and get together on one page. I also wanted to thank FDA for responding very rapidly in expediting a Freedom of Information Act request we submitted for the new

testing data, so thank you for that.

As you all know by now, there are three key parts to FDA's consumption advice: Don't eat shark, swordfish, king mackerel, or tilefish.

It is safe to eat up to 12 ounces of seafood each week except for these.

Do not eat the same type of seafood more than once a week.

Then, the advisory tells the target population that following this advice is safe and protective.

So, I want to go into why it is that that advice is not safe and not protective to follow in a lot of instances. The case study I want to use is canned tuna, but I will also point out that a number of fish that have even higher levels than canned albacore tuna later in the presentation.

First of all, this graph represents FDA's understanding of mercury levels in canned tuna as it has evolved through time. That second bar represents the average level of 0.17 ppm of mercury in canned tuna as FDA understood it when the 2001

advisory was issued. At that point, the agency had very little information to differentiate between kinds of tuna.

There was a 1993 study done by FDA. That is represented by the third bar. In that study, 19 samples of albacore tuna were tested and were found to have significantly higher levels of mercury than the bulk of the tuna samples FDA had in hand.

Well, now this new testing program from 2003 really gives FDA a lot more ability to differentiate between tuna types. So, now we see the first and fourth bars on that graph represents what is known now as the difference between light tuna and albacore tuna.

There are substantial numbers of samples and probably represent a fairly good estimate of what is really going on - 170 samples of albacore, even more samples than that of light tuna.

So, we see right off the bat, first of all, albacore tuna has twice the levels that FDA believed were generally in tuna for the 2001 advisory. Albacore tuna has 3 times the levels

that are found in light tuna.

So, out of this new understanding of mercury and out of the committee's recommendations last year, that FDA really needs to tell women what is going on with canned tuna, we get this advice. Mercury levels in tuna vary. Tuna steaks and canned albacore tuna generally contain higher levels of mercury than canned light tuna, and we also get this sentence after this, you can safely include tuna as part of your weekly fish consumption.

So, a read of this advice and FDA's own statement that this implicitly means 4 to 6 ounces of tuna can be safely consumed each week gives us a safe scenario under this advice of eating 6 ounces of canned albacore each week, and that is the scenario I would like to look at in detail here.

We find that the simple calculation outlined here that by eating 6 ounces of canned albacore tuna each week, a woman of average size would exceed a safe dose by about 30 percent. For instance, a woman who weighs 140 pounds, a weekly

serving size of 6 ounces, which is 170 grams, translates into a daily serving size of 24 grams, so we are thinking about average mercury exposures here and averaging them through time. Mercury concentration in canned albacore tuna based on FDA's new testing program is 0.36 ppm.

So, the amount of mercury this woman would ingest each day, of course, is her daily serving size times the mercury concentration, and that equates to 8.6 micrograms of mercury each day.

The body weight adjusted dose then, we just divide that number by her weight, 64 kilograms. Her long term steady state dose from this consumption pattern is 0.13 micrograms of mercury per kilogram of body weight per day.

We compare that against EPA's reference dose of 0.1 and find that it is substantially higher than a supposed safe level of exposure.

So, the conclusion that we find from this is that women who follow FDA's advice could face a significant risk of being exposed to mercury at levels above a safe dose.

You know one of the arguments that has been made is that women don't really eat this much tuna, so we don't need to explicitly say in the advisory please don't eat this much tuna. I just want to point out some women from FDA's focus groups conducted in 2000 who said that they do eat this much tuna.

I haven't looked at the transcripts from the recent focus groups, but the 2000 focus groups, FDA tested their messages on approximately 100 consumers maybe, and, of that, 5, I had pulled out 5 women from these groups. This woman ate tuna every day, 5 days a week for lunch for 7 weeks.

This woman ate more than a can and a half a week. She is referring to her long-term consumption in this sentence.

Another woman ate tuna every day for lunch because it was convenient. Another woman says she just bought a whole bunch of it because it was on sale for 39 or 49 cents a can.

Even another woman says she ate during the summer as part of being on the Adkins diet, a can

of tuna, a hard-boiled egg. That was her lunch, and she was on this diet in preparation for being pregnant.

Another woman just sums it up as "It is real cheap," and that's why women eat it, it is very convenient and cheap.

Now, albacore canned tuna is more expensive than light, but it is still relative inexpensive as a protein source for pregnant women.

We went one step further and looked at the distribution of women in the population and how much they weigh, and really a more detailed look at the risk faced by women who would eat 6 ounces of canned albacore tuna a week.

We conducted a Monte Carlo style model. This is simply a model that creates virtual women by picking measured body weights from CDC's NHANES population and pairing those with mercury concentrations from FDA's most recent albacore sampling program conducted this year.

So, we used body weights, measured body weights for 1,767 women. We used mercury

concentrations in canned albacore tuna from 170 samples, and we modeled a period of 40 weeks to simulate a typical length of pregnancy. We are just working with steady state concentrations here, we are not thinking about spikes or shorter term exposures.

The result of this model was that by eating a 6-ounce serving of albacore tuna weekly, we found that 74 percent of all women would exceed a safe dose of mercury for the duration of their pregnancy on average.

The detailed calculation results are shown here. The red line, the Y axis is, of course, the dose of mercury, the average dose a woman is exposed to over pregnancy in this model. The X axis is the percent of women who exceed that dose, and that red line represents the current reference dose from the Environmental Protection Agency.

So, you can see where the blue and red lines cross is really what we care about, and we show that that percent of women exceed, 74 percent of women exceed that dose.

This point has been made in other ways, but I would just like to say the point of this slide is to show that what FDA is doing in translating a risk model into individual advice for consumers is inappropriate.

FDA's simulations show that by chopping off, by forcing high-end seafood eaters to eat less seafood, they can ramp down populationwide risks from about 8 percent to 1 percent of over exceedences, but it does not, therefore, then translate that it is safe to eat up to that amount for an individual. In fact, in FDA's models, probably the women who tend to exceed the reference dose are those who are eating 12 ounces of fish a week, and by telling an individual that is a safe thing to do, you are actually advising them to do a fairly risky thing.

So, the model has really been used in an inappropriate way in developing advice for individual consumers.

I want to use this slide to point out two things. The data here represent the new data that

FDA collected this year in their testing program. Tilefish in this testing program showed an average concentration of 0.2 ppm. These fish are on the list of fish not to eat.

Now, these tests are substantially lower than tests that FDA based the initial advisory on, but one of the interesting things in the new data is that 5 other kinds of fish exceed the level that are in tilefish, I think gold-faced tilefish that were tested. Bluefish, sea trout, canned tuna, orange roughy, and grouper.

Now, the question is tilefish levels are certainly not well understood. Levels were much higher in the earlier sampling tests than they are shown here. It is not even clear what tilefish are. I think people are very confused about that. The data we were sent from FDA calls the fish "golden tilefish," which I don't find in my guidebooks or in FDA's regulatory market dictionary.

There is something called gold-faced tilefish, it might be that, there is also a Pacific

tilefish that is commonly referred to as "ocean whitefish," so it is not at all clear what tilefish are, and I think this is a concern because it is one of the four fish explicitly mentioned in the advisory, and I don't think the agency even has a real understanding of what it is.

It is an example of sort of the weak scientific underpinnings of many points in this advisory.

The second thing I want to point out is that the new data show that there are fish that have even higher levels of mercury than canned albacore tuna. We have shown that it is not safe to regularly consume canned albacore tuna. It would also not be safe to consume orange roughly or grouper if these samples are representative of what is really going on in these species.

We also find that tuna steaks and American lobster according to FDA's testing data have similarly high levels.

This is a quick comparison of data used by FDA to develop their 2001 seafood consumption

advisory shown in the lighter bars, and then the darker bars represent what their new data shows.

I just want to point out that in a couple of key instances, the new data, even though the sample sizes are very small, increase the agency's understanding of what is going on with that fish dramatically. In these cases, it seems that the mean levels for this fish group or sea trout and bluefish are substantially higher than what the agency previously believed.

This is a concern for a couple of reasons. The sample sizes FDA is working with are so small that even 20 samples can significantly alter the agency's understanding of concentrations in fish. We don't see the kind of statistically valid sample sizes we need really to have a solid scientific underpinning for an important public health advisory like this.

This is another instance where I am just showing you the sample sizes FDA is working with in this risk model in the development of this public health advisory.

On the lefthand side of this chart are the sample sizes FDA is working with for the top 10 seafood in the U.S. - canned tuna, crabs, pollocks, salmon, catfish, shrimp, cod, flatfish, tilapia,

and clams. This is ordered by sample size.

There are only 3 kinds of fish in the top 10 seafood for which FDA has more than 100 samples. For 6 of these, FDA is working with fewer than 30 samples.

I just compare that briefly to an assessment FDA recently did on children's exposure to organophosphate pesticides. This is just a tiny fraction of their sampling program. I pulled out some fruits and vegetables they test as part of the underpinning to their assessment of just one organophosphate pesticide of the many analyzed dimethoates. They sampled a minimum of hundreds of samples for each of the fruits and vegetables that were included in the assessment.

They sampled over 2,000 carrots, they sampled almost 2,500 apples, over 1,000 bananas to provide them the kind of scientific underpinning

that they needed for this public health advisory, and the risks are of similar magnitude to what we are talking about here, if not greater magnitude here than EPA's analysis.

So, I just want to point out briefly, just pull out 3 of the fish in the top 10 to show you really the kinds of complexities we are working with and the kinds of sample sizes that are really needed to understand what is going on here.

FDA has tested 25 samples of shrimp. Shrimp is the number one seafood in the U.S. The National Marine Fisheries Service data shows it is caught commercially in 20 states, it is imported from 21 countries, it is farmed, it is caught in the wild.

We eat such a diverse source of shrimp and we only have 25 samples, and for the top seafood in the U.S., this does not seem like a solid scientific basis for moving forward with an advisory that includes advice on shrimp.

FDA has tested 6 clams. Claims is the No. 6 seafood in the U.S. The National Marine

Fisheries Service says it's landed in 9 states, we import from 30 countries. Six samples of clams is not enough to move forward with a public health advisory on clams.

FDA has tested 8 tilapia, the No. 9 seafood in the U.S. It is landed commercially in 2 states, we import from 27 countries. Clearly another case where the sample size is insufficient for FDA to understand what the mercury distribution might be in that particular fish, and clearly, the sample size is not sufficient to move forward on that fish with a public health advisory that includes advice for women to consume that fish.

DR. MILLER: Would you summarize, please.

MS. HOULIHAN: Yes. I am on the last slide.

Our recommendations are, first of all, obviously, FDA should test fish. They need to adequately characterize the distribution of mercury levels in the U.S. seafood supply. They can't get there by testing 20 fish a year for a fraction of the species we eat.

This has got to be a big comprehensive sampling program that has some statistical backing, and I hope the committee can recommend that FDA do this because I think it would help them shake loose some funding to get that done, which would require substantial funding.

FDA should issue an advisory that tells women what fish are safe to eat in quantities that meet omega-3 requirements. Two of three peer reviewers told FDA specifically please consider omega-3's when you are developing this advisory. We think it is really important, women need to be able to consume fish safely to meet their omega-3 requirements. It is very important for proper fetal brain development.

One of the key things FDA can do in that department is provide consumers with a list of safe fish. FDA should also add canned albacore tuna, as well as the other species I mentioned with high levels, to the list of fish women of childbearing age and children should not eat.

Any questions?

DR. MILLER: Yes.

DR. ACHOLONU: A few speakers have made the observation that some of the common names varied depending on where you are.

Do you think it would be advisable for the FDA to include the scientific name of the fish, put that in parentheses in the advisory to be distributed to the public?

MS. HOULIHAN: I think that is absolutely critical, and I think FDA has got to figure out what is going on in the various states, so that people get the right advice in the right state.

I mean you brought up the example of cod, and I will pull that out, because cod, 71 percent of our cod we eat is domestically caught, Pacific cod from Alaska, 12 percent is imported Atlantic cod, 17 percent is imported other cod. FDA has 20 samples of cod, most of it is domestic. They have 2 samples just called "cod," one sample of black cod that I actually think is from a completely different family of fish.

So, it is so complex and will vary so

much, and it is such important advice to get out to people that it is really going to require that FDA and EPA figure this out.

DR. MILLER: Yes.

DR. NELSON: Considering your statement that you want the advisory to be science based, and the data you provided about the analysis for

tilapia and shrimp, are you suggesting that FDA

consider those guilty until proven innocent, or disregard those species, or what?

MS. HOULIHAN: I think because of the import to public health, if I were in charge of FDA, I think what I would do is move forward with advice on fish for which they have statistically significant numbers of samples, and that includes canned tuna. So, I feel like they are in a good position now to include albacore canned tuna on the list.

I would also advocate for providing a list based on the agency's current understanding of what low mercury fish are, so women know what is safe to eat, and then, at the same time, move forward very

aggressively on testing fish in adequate levels, so they really get a much more in-depth understanding of the distribution.

DR. NELSON: I also wanted to comment on the emphasis on a safe level, or, in quotes, on a "safe" level in reference to the RfD, and wanting sound science and something definitive.

I don't believe the RfD is quite that solid in that sense, not the calculation, but the concept of the safety, and I am not convinced that somebody consuming 0.13 as opposed to 0.1 is a significant increase or decrease in safety, if you will.

MS. HOULIHAN: Right.

DR. NELSON: I think the RfD is based on consumption over a lifetime, and I think that is why, in earlier drafts of the advisory, we saw a statement like if occasionally you consume more, it is not the end of the world, but clearly, the advice needs to be there to moderate the consumption.

MS. HOULIHAN: And I think it is also

important to remember that the reference dose is consistent with NAS recommended benchmark dose which is derived from fetal cord blood levels, and the NAS said that those are best thought as corresponding to probably a trimester of pregnancy.

So, in that instance, FDA's assessment is not conservative, but they are considering steady state dose over an entire pregnancy, they are not considering excursions above the RfD for a trimester or shorter periods during pregnancy.

DR. DWYER: It seems to me two things are becoming clear from what you have said. One is just the notion of modeling, I don't think you are disagreeing with. You are just saying you think you have a better model, right?

MS. HOULIHAN: I think that the data that underlies this model is extraordinarily weak.

DR. DWYER: It seems to me one of the pieces of data that is weak, that you didn't mention as much, that I thought I heard Dr. Acheson say that they were trying to remedy is the issue of exposures.

In other words, and it is complicated by what Dr. Alex just said about the names, in other words, for things that are not very commonly eaten, not perhaps tunafish, but some of these other fish, you really have to do better than what we are doing right now in national survey data.

It seems to me it is very important in our recommendations for the future that we include better estimates of recalls than we get right now. I think there is some work being done now on a propensity sort of questionnaire to add to the data that we could get from NHANES, and I hope that is done.

The second point is exposure depends on knowing what people are eating, and the other thing it depends on, as you pointed out, were food composition values, and in this case, this contaminant. I think it is very important, as you do I guess, to get as many representative data as we can on the mercury levels in these various kinds of seafood.

Again, I wonder if the only way to get

them is having FDA go out and do a huge survey. It probably doesn't come as news to you, but there are many values for many nutrients that are not much better than the values we are talking about here. We don't have a lot of food composition data even sometimes on essential nutrients.

So, again, I go back. Are there any other sources other than going out and doing food surveys where we could get more data, perhaps industry, perhaps states have data, that are collected in a uniform fashion using appropriate standards for judging how much mercury there is, just to get on with this instead of going into the fourth millennium still arguing.

DR. MILLER: Dr. Russell.

DR. RUSSELL: I wonder, are you suggesting that FDA and EPA do a continual survey of fish, kind of ongoing, with the idea that maybe levels are rising in certain fish species?

MS. HOULIHAN: It may be that levels are changing in certain species. There aren't the data to say that definitively. But it makes a lot of

sense particularly for fish that live near the coast where land-based pollution may be much more of an issue.

What I would like to see is a big comprehensive testing program, one big bang program to try to get a really good grasp of this problem, get a great consumer advisory developed out of that, and then a smaller program of ongoing testing that would try to get at some of the issues of trend or levels going up with time.

DR. MILLER: But are you saying that FDA and EPA should delay issuing their advisory?

MS. HOULIHAN: I don't think we lose much by not issuing this current draft advisory because it doesn't really represent any more substantive information for consumers than the previous advisory.

What I do advocate for the agency going forward with at this point is getting information to people much more specifically on canned tuna, an explicit warning, and explicitly telling pregnant women to not eat canned albacore tuna, and I would

also just advocate that FDA move forward with getting a list of fish to women that are believed to be low in mercury at this point.

DR. RUSSELL: Just one other thing I have been thinking about. If you come out with a list of fish that you say are safe based on mercury, are you concerned that down the road, that some of those fish on the safe list will be contaminated with PCBs or something else, and then the message has become just so very confusing about what you are telling people to do?

MS. HOULIHAN: Right, and if not more, it's a three-pronged problem because omega-3's are so critical, it is our most important source of omega-3's, and mercury and PCBs are both big pollution issues in fish.

So, for instance, if FDA moved forward with recommending that people eat farm salmon, that is probably not safe from the perspective of PCBs. So, I have advocated for a long time that the agency take a more holistic look at seafood.

DR. MILLER: We are going to move on. We

have several speakers still and it is only fair they have their chance.

Thank you.

The next speaker is Dr. Rick Jarman from the National Food Processors Association.

MS. APPLEBAUM: I am also from the National Food Processors Association, but I am Rona Applebaum instead of Rick Jarman.

Good morning. I do work for the National Food Processors Association. I work as their Executive Vice President and Chief Science Officer. NFPA is the principal scientific and technical trade association for the food industry. We represent over 400 processing and supplier companies.

Our focus is public policy and science issues involving food safety, food security, nutrition, technical and regulatory matters, and consumer affairs, and NFPA has no financial relationships with either of the sponsors.

We very much appreciate this opportunity to share our comments on FDA's and EPA's activities

regarding the revisions to the agency's consumer advisory on methylmercury and fish consumption. We are strong advocates for the use of sound science as the basis for any and all dietary advice given to consumers.

We believe the FDA is to be commended for addressing the recommendations given to them by the Food Advisory Committee and moving forward in a timely manner to develop and test the revised consumer advisory.

My comments this afternoon will focus on the consumer advisory, consumer testing, as well as the need for more research. Advice to consumers on fish consumption is very complex. Advice to consumers in general is very complex. It is critical that any action taken in regards to consumer advisories assess the potential adverse impacts that may result due to the reaction on the part of the public to such advice.

The potential impact of advisories, including those designed to improve public health, must consider the full range of implications that

may result to ensure the initial good intent of the advisory follows through to positive outcomes. More on this in a few moments.

Thus far, we believe FDA is meeting the challenges of integrating information from a variety of sources on the numerous factors that must be considered in providing sound actionable advice to the public on safely consuming fish which has repeatedly been recognized as contributing to a healthful diet.

It is clear that FDA is considering all of the key issues including quantities consumed and the benefits of fish consumption in order to provide consumers with the facts and the necessary advice on methylmercury and fish consumption.

NFPA has actively followed FDA's process of reviewing the consumer advisory. We believe that gaining insight directly from consumers is essential.

For any consumer advisory to be effective, they must be both understood and correctly interpreted by consumers. Messages are important,

but it is critical that their ultimate result be a positive behavioral change.

To this end, message testing is an absolute necessity, and such testing appropriately has been an integral part of FDA's activities in reviewing its consumer advisory.

Throughout the process of reviewing and revising this consumer advisory, FDA has acknowledged the difficulty of wording an advisory, so that it provides appropriate guidance to the populations at risk to help these populations decrease their methylmercury exposure while not discouraging consumers, or worse yet, steering consumers away from diets containing fish and other seafood.

Let's not forget the majority of food purchases are done by female heads of households. What they choose to bring into their homes is not only their dietary regimen, but also the dietary regimen of their family.

To this end, based on our observations from the FDA focus group sessions, we strongly

believe that further consumer testing is necessary to ensure that any revisions to this consumer advisory are effective in better informing consumers.

What we must avoid at all costs is the unintended effect--and it has been discussed

today--of the advisory being read, understood, and interpreted as a warning against consuming all fish. Warnings, by nature, and its consumer research supports, can be translated into complete avoidance behaviors especially if alternatives exist.

The concern here is that alternatives that might be selected--and I am not referring to fish alternatives, I am referring to non-fish alternatives--will not be identical substitutes necessarily.

In this instance, the concern that bears mentioning is the avoidance again of all fish with substitutes that do not provide the equivalent nutritional benefits of fish.

This is a major concern and is

contradictory to the advice given by many public health professionals, public health societies, and public health agencies and departments including FDA, HHS, and USDA.

The message fish can and should be part of a healthful diet is sound. Messages that may be interpreted as no fish are not a benefit to public health.

In addition to the necessary research that must be done to ensure advisories inform and not result in negative behaviors, other research will be helpful, as well, in providing FDA with further information on fish and methylmercury exposure.

We are now pursuing one such research direction. While it is true that methylmercury exposure poses health risks, it is also true that fish consumption confers real health benefits. These benefits would be lost if consumption of all fish--and I repeat all fish--were reduced in an attempt to reduce methylmercury exposure where action is being based on incomplete information.

Clearly, a comparison of the methylmercury

risks to the risks of reduced fish consumption is necessary to ensure that any policy, including the way in which advisories are worded, helps rather than harms public health.

Through the NFPA Research Foundation, a project is now underway to review the data published on the impact to health of dietary exposure to methylmercury, and evaluate and compare the risks of benefits of efforts aimed at influencing the consumption of fish.

Some might call this a risk-risk evaluation, others a risk tradeoff, but it is currently being undertaken, and you will hear more about this research from the project director, Dr. Joshua Cohen, of the Harvard Center for Risk Analysis.

In summary, while FDA's revision of its consumer advisory is still a work in progress, the agency is to be commended for its efforts to carry out the recommendations of the Food Advisory Committee.

We believe consumer testing is necessary,

will be helpful to ensure that the consumer advisory meets the goal of better informing the

at-risk population on ways to decrease their methylmercury exposure while not resulting in behaviors that may direct them away from all fish and other seafood.

Finally, we must remember that consumer advisories and messages concerning public health are only tools for public health education, and are not complete solutions in and of themselves, nor should they be.

NRPA thanks you, FDA, EPA, and the Advisory Committee for the opportunity to provide these comments.

DR. MILLER: Thank you.

Just a quick question. Dr. Dwyer has several times raised this possibility of expanding the database from which these advisories are made with data from the industry.

Would NFPA be willing to cooperate in developing that data?

MS. APPLEBAUM: NFPA has been involved in

developing a number of data on a number of issues. There was a recent publication on the levels of methylmercury in fish recently reported. I apologize, Dr. Sanford, for not knowing exactly the publication, but when we are asked to provide such information, we have stepped forward.

DR. DWYER: Would that be publicly available, going into a database that was--or is it just your own publication?

MS. APPLEBAUM: The publication, it's in the peer-reviewed literature, so there is information out there.

As with anything, Dr. Dwyer, we would talk with our companies in terms of developing ideas, but if the data is there, we would want to provide it to the stakeholders.

DR. DWYER: I have done a lot of giving advice to people about eating things and not eating things, and very often they don't do either of those things.

Can you think of any government advisory that has ever substantially decreased consumption,

and if so, what are those advisories?

MS. APPLEBAUM: Well, I think in terms of messages that were given out earlier, the last decade and in the late '80s, relating to cholesterol and fat, consumers heeded it.

What was missing in that point, and, you know, when you look at the National Cholesterol Education Program and the progress that was made there, that was one that I think that had benefit, but when you look in terms of the focus exclusively on fat messages and the impact in terms of overweight and obesity, in terms of the lost message on calories, we have to be very careful as it relates--and you know this better than I do--as relates to giving consumer messages, so that easy messages in terms of the easy take home, is not what drives the issue of bigger impact.

That is why, at the end, in terms of my final comments, advisories and messages are only one part, one tool in terms of a public health education program, and not solutions in and of themselves.

DR. MILLER: Thank you.

The next speaker is Dr. Diana Zuckerman from the National Center for Policy Research.

DR. ZUCKERMAN: I am Dr. Diana Zuckerman, President of the National Center for Policy Research for Women and Families, and our Center is a think tank that works to improve the health of women, children, and families, and we don't take contributions from anyone that makes any product that we might at some time say something nice about or something not so nice about.

Like you, our goal is to ensure that scientific information is made understandable and available in ways that safeguard everyone's health and make sure that consumers can make educated choices.

I have been attending FDA meetings on this topic for several years, and I am glad to see real progress, and I really thank you because I think a lot of that progress is really due to this Advisory Committee.

However, the proposed FDA/EPA advisory is

confusing, as we have heard people say, and the FDA's own scientists have found that the 12 ounce limit is too high to reduce mercury levels in women.

As an epidemiologist, I feel very strongly that data are essential in answering the questions we need to answer and providing information. According to the information provided to this Advisory Committee yesterday by Dr. Carrington, the proposed limit of 12 ounces of fish per week would not significantly decrease methylmercury levels in women.

According to the FDA's analysis, 12 ounces of tuna, particularly albacore tuna, and some other fish in the moderate category is just too high. So, the question is why is it in this draft advisory.

Your task is incredibly difficult and very important, and we are counting on you. You need to make sure that adults are warned, in way that they will understand and in ways that they will remember, so that children and pregnant and

nursing women are not harmed. So far the FDA has not succeeded in getting the message out to the people who really need it.

Our Center specializes in explaining research-based information to the general public, and we have been working very closely with the National Cancer Institute on some patient booklets, and I think it is informative, the experience we have had with them.

In preparing a patient booklet, they hired a specialist to translate all this research-based information that was going to patients, to translate into simple words and simple sentences that were suitable for women at the middle school reading level.

That seems very dramatic to me and drastic, and I have to admit I didn't like it at all because you lose so much information when you are trying to get down to that middle school level, but apparently that is what NIH does for their patient booklet, they aim for a middle school level because there are, in fact, a lot of people in this

country who, although they may be high school graduates, cannot read at a higher level than that.

They call this plain language. The words have to be short, so they use words like mercury instead of methylmercury, they might even use words like often instead of frequent. But it isn't just the words, it is really just dumbing-down the vocabulary.

It is also having ideas that are simple and straightforward and clear. So, using that as a guideline, a methylmercury advisory needs to say at least two things. Some fish, actually many fish are very good for you, and some fish are potentially dangerous if you are pregnant or a child or a woman who is nursing.

Now, we think that people can understand these two messages if you explain which fish are safe, which fish are not safe, and the ones in between. But we think what is wrong with the advisory as it reads now, is that it tries to do something a little different.

It tries to say fish are good, and these

are the fish that are bad, and that is not logical. That doesn't follow logically and it feels like spin control. It doesn't feel like advice for consumers, it feels like some kind of politically correct effort to say fish are good, but just these fish are bad, when, in fact, really what you want to say is these are the fish that are good, and these are the fish that are bad, and you actually might have to say bad even though we don't like to use terms like that.

With all due respect, I am just shocked by the way this process works, because I know from my experience with the National Cancer Institute that for $500 or $1,000, you hire one of these specialists, they write it, they rewrite something, make sure that the language is clear, the ideas are clear, but that it is still research based, and it takes them a few hours to do this. It is not a huge task.

I also agree that a simpler way to do this is to have separate advisories, one for pregnant women, nursing women, a different one for children,

and a different one for other adults, and perhaps one for people with heart problems. That's new information for me, I didn't know about that.

It feels to us that the underlying problem is the FDA's reluctance--and perhaps EPA's reluctance--to say that some popular fish are relatively high in mercury.

They just don't want to say it. But we have to get over that because if we don't clearly say which fish are dangerous and which fish are safe, people really will come away with the wrong message, and that will be more dangerous for everyone.

DR. MILLER: Could you summarize, please.

DR. ZUCKERMAN: Yes, I can. Thank you.

I just want to say that I know that some experts will be pointing out that we don't know exactly how dangerous methylmercury is for pregnant women and young children, we don't have all the data we need.

It might not be as dangerous as some people think or as the Institute of Medicine has

estimated, but none of us would want to include our children or our grandchildren in that kind of study to expose them.

In our experience, the Institute of Medicine, which is very concerned about this, is very cautious, so we take their concerns very seriously and we hope that you will in trying to figure out how to present this information quickly.

I think that is the other thing, not to delay this too much, not to use the proposed advisory as it is written, but have something that is simpler to understand, but that gets some of that information out as soon as possible.

Are there any questions?

DR. MILLER: Comments or questions? Yes.

DR. ACHOLONU: You are advocating that if the EPA puts out different kinds of advisories, wouldn't this open a can of worms, will this not cause confusion, and wouldn't several groups be clamoring and asking for their own?

DR. ZUCKERMAN: Well, I think that an advisory, if it is very complicated, even saying

women who are pregnant, women who might become pregnant, and women who are nursing, that alone is somewhat complicated, and when you add children to that, and you are not exactly sure what the levels are for children, I think it is very difficult.

So, I think it is fine to have short summaries that are targeted for different groups, and then maybe have the one part that is the same for everybody, which explains a little bit about what methylmercury is or what mercury is, and why is it potentially dangerous.

So, I don't think so. I do think you might even need a different kind of advisory for physicians. They are not going to want the 8th grade version of this. I think it would be fine to have a more sophisticated version, they would want a short one, but maybe not 8th grade level, for physicians than the one for the general public because the needs are somewhat different.

DR. ACHOLONU: So, about how many do you think we should have, two, three, or four?

DR. ZUCKERMAN: I think it would be very

helpful to have simple ones for pregnant women, women who might become pregnant, one for kids, and one for other adults who are not of reproductive age at the simple level, and then perhaps one that combines all of those things for a more sophisticated audience, such as physicians.

DR. MILLER: Thank you.

The next speaker is Dr. Joshua Cohen of the Harvard Center for Risk Analysis.

DR. COHEN: My name is Joshua Cohen. I am the senior research associate at the Harvard Center for Risk Analysis at the Harvard School of Public Health. I am here today to discuss the work our Center is conducting to inform policies addressing the presence of methylmercury in commercially caught fish. I appreciate the opportunity to address the FDA Food Advisory Committee today.

I will be describing the work related to a grant funded by the National Food Processors Association Research Foundation. That grant has also funded by travel expenses today, and I do not have any connection to the sponsors of this

meeting.

The issue of methylmercury in commercially caught fish is particularly difficult to address because fish consumption has health effects that cut two ways. Methylmercury is known to be a neurotoxin to which unborn children may be especially vulnerable. Methylmercury may also affect adults with recent studies suggesting that it may increase the risk of coronary heart disease.

On the other hand, fish are a rich source of nutrients, in particular omega-3 fatty acids, that are thought to aid neurodevelopment during the perinatal period. These nutrients may also reduce the risk of mortality associated with coronary heart disease in adults, so it cuts two ways.

In a project funded by the NFPA Research Foundation, the Harvard Center for Risk Analysis is currently addressing this policy issue by quantitatively comparing the health risks and benefits of fish consumption. The idea is that policies affecting fish consumption in either direction also influence these risks and benefits.

The only way to know whether a change in fish consumption is beneficial on net is to quantify the risks and benefits and then to compare them. The Center for Risk Analysis is currently drafting several manuscripts that quantify the relationship between fish consumption and these various health effects. A future paper will aggregate these results and quantify the net health benefits or the net health loss of hypothetical changes in fish consumption.

The risk tradeoff analysis we are conducting in the context of methylmercury in fish differs significantly from the evaluation of methylmercury conducted by various regulatory agencies. For example, EPA's reference dose attempts to identify a level below which exposure to methylmercury is of limited concern.

While this benchmark can be useful for the purpose of identifying exposures that are worthy of further consideration, it does not help decisionmakers to determine how badly public health will be affected if exposures exceed this limit,

nor does it help us to understand the public health costs that may be associated with even those exposures below this limit.

Importantly, the reference dose does not take into account the nutritional benefits of fish consumption. To complicate matters, it is not clear how the advisory affects fish consumption patterns as has been discussed here extensively today.

The key point is this. The focus on determining the impact of an advisory on the proportion of women above the reference dose is inadequate from a public health perspective. To know if an advisory is a good idea, we need to understand how it will influence fish consumption for the whole population, not just the target population, how the change in consumption will influence both exposure to methylmercury and the intake of nutrients, and how these changes will influence the probability of different health effects.

Because such an analysis has not been

conducted, we do not know what the net public health impacts of advisories are. We hope that the project we are currently involved in will help to shed light on this issue.

DR. MILLER: Thank you.

Comments or questions?

DR. LUND: Dr. Cohen, I didn't hear the date when you expect some of these results to be coming out.

DR. COHEN: Well, the manuscripts are virtually complete. We are going to be submitting them for peer-reviewed journals, and, of course, you know that is an uncertain proposition in terms of the timing, but we would hope that a year from now, these papers will be in the peer-reviewed literature.

DR. DURST: You are talking about developing an advisory for the entire population, which, since this one which is narrower, is already fairly complicated, would you agree with the previous speaker in that a number of different advisories would be more beneficial in terms of

directing it towards the various populations?

DR. COHEN: Actually, perhaps I wasn't clear. I am not advising or I am not suggesting that an advisory for the whole population is a good or a bad thing. What I am saying is that whatever advisory is considered, be it the one that EPA and FDA described this morning or anything else, what is important is to figure out how that is going to change people's fish consumption patterns and then trace that through to changes in the incidence of various health effects.

What I was saying in relation to the population at large is that even if you target an advisory to pregnant women, it may influence consumption among other members of the population, and that needs to be taken into account.

DR. HEIMBURGER: You have put us in a very difficult position by telling us that you have data that you are submitting for publication and an advisory could come out very soon, well before your--I don't know, I am new to the process, maybe it won't come out soon--well before your data are

published.

Can you give us any indications of how your data might specifically impact the advisability of any of the recommendations made in the advisory?

DR. COHEN: Unfortunately, as you know, when you go into the peer-review process, you know, the peer reviewers can cause you to change things, so I think it would be premature for me to say, well, the answer is X and then next year it turns out to be X plus or minus something, and that is just confusing for anybody.

DR. HEIMBURGER: Well, then, what you have done is you have put us into--I mean data are always be in flux, there will always be new data come out, and we really don't know how to respond.

DR. COHEN: Okay. Well, I mean I would say what we are providing isn't new data, it's an aggregation of the existing data. What I am really trying to stress here is that before the government goes ahead and puts out an advisory that is going to affect people's behavior, they need to

understand how it is going to influence that behavior, and if the government doesn't understand that, then, maybe it is not a good idea to do it.

Otherwise, I mean you don't know, you just don't know if this is going to be net good or net bad. It might be net good, but you don't know.

DR. MILLER: The problem really is that if you have a situation that has a significant public health outcome, the longer you wait, the greater the risk is.

The other point is that, and I still think it is something for this committee to suggest even though it is self-evident, that this process that FDA and EPA are going through ought to be an ongoing one and that changes in the advisory should be made on the basis of relatively short periods of time as new data becomes available and a new analysis is going to be available.

I mean what struck me about this business going through the last two meetings is how things seem to be changing every month. There are new data, there are new approaches to the data, there

are new ways of analyzing the data, and if we waited until the questions were all answered, there would be no advisory at all.

I understand the point you are trying to make and I agree with it, but the question is a matter of time, and you are not prepared to share that.

DR. COHEN: I mean we don't even have the aggregation yet, so even if I wanted to, I couldn't share it and besides it is not even in the

peer-reviewed literature.

DR. MILLER: I don't mean that critically. I am just saying that is the reality of life for the people who are going to write this thing. We are not going to write this thing. This committee is going to make recommendations to the people who will write this thing, whatever point they take.

But I would suggest that the committee consider that kind of recommendation to be made to the agency, otherwise, if we are trying to pick things out, we are never going to get any kind of recommendation.

DR. COHEN: Yes, I am I recognize obviously, you know, things have to be done in a timely manner and while you wait, people are living and being exposed to things. I guess I would urge you to advise FDA and EPA to at least address the broader public health question, that is, what is the net overall effect of this, not just focus on the mercury or on the nutrients. I mean you have to look at things holistically, otherwise, you don't know if you are doing net good or net bad.

DR. MILLER: Good. Norman.

DR. KRINSKY: Could you just tell me how you were able to evaluate how the advisory would alter fish consumption. Do you use focus groups of some equation?

DR. COHEN: No. What we have done, the focus of our work is essentially looking at dose response, to say if omega-3 fatty acid consumption intake increases by thus and so, what benefits does that confer, likewise, for methylmercury on the adverse health effects.

It is very difficult. We have not focused

our research on looking at how fish consumption for a particular advisory would affect things. We will consider some hypothetical changes to illustrate what the net impact will be, but, of course, without knowing the exact wording and conducting the type of research which FDA and EPA have described, but I think they need to do more and do more extensive research to figure out how the population, fish consumption will be affected, you know, that the overall picture is not going to be complete.

So, our component is going to be the

dose-response relationships for the omega-3 fatty acids and for the methylmercury, which is to think from an RfD. An RfD, reference dose, I am sorry, does not tell you what is going to happen below or above, as I think someone even mentioned on the panel this morning, the difference between 0.13 micrograms per kilogram per day, and 0.1, you know, the RfD says 0.13 is bad, 0.09 is okay. Well, in reality, that is not true. There is a gradation, and that is what we are going to try to explain

quantitatively, so that the net benefits of changes in fish consumption or the net adverse effects can be characterized.

DR. MILLER: Thank you very much.

Is this an important question, Johanna?

DR. DWYER: Of course, Dr. Miller, all of my questions are important.

[Laughter.]

DR. DWYER: Thank you for clarifying what you are up to. What I was wondering, since the focus of the analysis is primarily on omega-3 fatty acids, two questions.

One is accounting for other sources in the diet than fish, and, secondly, it is my understanding an evidence report has been in process, I think it is about a year, through NIH. I assume that you would be taking that into account in your analysis, or have you already submitted the manuscripts? I gather it will be out in two or three months.

DR. COHEN: First of all, we have not already submitted the manuscripts. We focused on

the omega-3 fatty acids because that seems to be the key issue in terms of nutritional benefits.

Optimally, one would want to look at not just the omega-3 fatty acids, but on the other nutritional benefits. But, you know, in order to get this done, this we think is a very useful first cut, and even so, it is taking time.

Now, the NIH report, I am not sure I am familiar with that.

DR. DWYER: I think it is through the evidence-based practice centers, and I know it has been in press for about a year.

DR. COHEN: On omega-3 fatty acids?

DR. DWYER: That is correct.

DR. COHEN: I am trying to remember. I think we have that report, but I can't--

DR. DWYER: If you do, that is surprising because I don't believe the NIH has it yet.

DR. COHEN: Well, I don't know. Again, I can't remember exactly which government reports we have looked at, so I guess I just don't know the answer to that question without knowing exactly

which report you are talking about.

DR. MILLER: I think we had better move on. Thank you.

The next is Mr. John Stiker from the Bumble Bee Seafoods and U.S. Tuna Foundation.

MR. STIKER: Thanks for having me. My name is John Stiker. I am a Senior Vice President at Bumble Bee Seafoods, so in the spirit of disclosure, I work for tuna company.

I had promised Dr. Acheson yesterday that I would include a little bit of kind of a Tuna 101, as I heard some of the questions about differences between white meat and light meat, where tuna are harvested, but I think I have only got about eight minutes, and I am going to be talking fast as it is, so I have included that as an appendix in the presentation that has been handed out.

DR. MILLER: Five minutes.

MR. STIKER: I thought I had eight, so I will go really fast. So, if there are questions on that afterwards, I would be happy to field them.

I have titled this presentation The Curve

Has Changed, and the curve that I am referring to is the curve that we tend to ground ourselves in, which is the NHANES curve, which was plotted out in the July 2002 Food Advisory Committee.

This one provided critical data on actual blood levels among American women and here is where the 7 to 8 percent of women over the EPA RfD curve came in, which led to that often cited 300,000 babies at risk claim.

Worth remembering, though, as we think about it, is that the average safety and uncertainty factor for that population that was above the EPA reference dose was, on average, still 8-fold, and none even approached the Faroes NOAEL.

So, from the tuna industry perspective, we do consider the reports of the methylmercury health crisis to be overblown. We do, however, support the concept of minimizing methylmercury exposure, but we believe it should be done responsibly, balancing the need to maintain or even increase overall seafood consumption given its health benefits.

So, the question that we ask ourselves as we are now four years post-NHANES and considering revising the advisory is do we have any new data which suggests that food consumption or methylmercury intake is up since NHANES or even that it is static, or do we have new data which suggests that seafood consumption and methylmercury intake is down since the NHANES and, since the advisory, is the curve improving.

So, let's take a look quickly at what the data tells us about the impact of the advisory. First, the study published by Dr. Emily Oken. Hopefully, you have all seen it in Obstetrics and Gynecology, demonstrated a dramatic dropoff in fish consumption among pregnant women in Massachusetts post-advisory.

For canned tuna, the percent change in consumption was down 28 percent--ouch-- for overall seafood, 17 percent. I laugh about it, but I would tell you that I am not sure that is even the impact that you want to have with that advisory.

Yet, despite the fact that many women may

not read it, you get the headlines like this morning's Washington Post, "Federal warning on tuna planned." I can tell you exactly what impact that is going to have on consumption.

So, it is being heard and felt throughout the seafood industry. In fact, here is the data released by NOAA and NMFS on seafood consumption, and you can see what happened to tuna. We used to refer to tuna as the most popularly consumed seafood in America. Post-advisory, it's not anymore. In fact, in 2001, post-advisory, we experienced a 17 percent decline in consumption.

We had a very modest recovery in 2002, but that is a 14 percent two-year drop in consumption post-advisory. Contrast that versus the years that the NHANES data was collected. So, in the NHANES years, we were seeing about 3 1/2 pounds of tuna consumption per year. That has dropped notably since the advisory.

To put that in perspective from a relative health point, however, you can look at ounces per week as we think about the 12 ounces per week

number. From our standpoint, we have taken consumers who eat very little canned tuna to begin with, about 1.1 ounces per week, and encouraged them to eat even less.

The average per capita consumption, as you see there, is about 1 ounce per week. We split in our industry about two-thirds or sometimes 70 percent light meat, one-third or 30 percent white meat, which suggests average albacore consumption of consumers of 0.3 ounces per week. Even at the 95th percentile, which starts to get pretty far up there, canned tuna consumption is less than 5 ounces per week or less than 2 ounces per week of albacore.

This is despite the fact that tuna and, in particular, albacore tuna is the second highest source of omega-3 fatty acids of all common seafoods and certainly the most affordable.

As you look through that list and think about a trip to your local grocery store, you are going to pay 3.99 to 4.99 a pound for almost every seafood that is up there. Chunk light tuna

typically sells, as you will see in the back of your packet, for about 69 cents a can, albacore sells for about 99 cents a can. It is a terrific economical value for the U.S. consumer.

So, while the perceived risk may be abated, as Dr. Cohen seemed to allude, the tradeoff by reducing omega-3 consumption from canned tuna is very real, something is going on, and we know that the benefits to omega-3's to both mother and child are well documented from fetal brain and retinal development to achieving full-term delivery, to other maternal benefits.

At Bumble Bee, we wondered where is that tuna volume going. Tuna is unique among all fish in that it is the only fish commonly used in a sandwich. In fact, you can see there that over half of our consumption is in a tuna sandwich. So, it is not easily replaceable by other seafoods. You are not going to have a salmon sandwich or a tilapia sandwich, it just doesn't happen.

So, we commissioned Information Resources, which is a syndicated data company, to conduct a

study on that topic using household panel data. As you can see here, here is how tuna stacks up in the world of sandwiches. The most commonly consumed sandwich in America today--I don't know this--is the ham sandwich, followed by PB&J, hamburgers, turkey, cheese, hot dogs. Tuna is Number 7.

We are pretty pleased with that fact. We would love to see it higher, but there we stand.

What IR did is they looked at pregnant households in their household panel comprised of thousands of households who became pregnant prior to the FDA advisory. Then, they looked at a set of households who became pregnant post-advisory to take a look at what happened to their seafood consumption.

Prior to the advisory, households becoming pregnant would typically tend to increase their seafood intake during their pregnancy, not by a lot, but given the relatively low starting base of seafood consumption in America, we would consider this to be a good thing, a healthy response as they increase a food that is really good for them.

Post-advisory, as we saw in the Oken and the NOAA data, seafood consumption went down relative to control, but the page I want to focus on is the next page, which shows what happened to sandwich replacements.

Well, sliced lunch meat goes through the roof. Prepared pasta dinners, which is food like Chef Boyardee, microwaveable dinners, packaged turkey, hot dogs, packaged baloney are all increasing for these pregnant women.

So, these households, which aren't even close to eating 12 ounces a week of seafood, they are buying on average 6 ounces or less for the entire household, are now decreasing their consumption of seafood and instead increasing their consumption of what we call shelf-stable convenience foods, which is microwaveable packaged dinners, not terribly good for you, and deli meat sandwich alternatives. I shudder to tell you what those look like.

I know Rona Applebaum wouldn't want me to contrast versus other foods, but it is out there,

there it is. In fact, the next page gives you that specific comparison of tuna relative to the other sandwich alternatives. This is pulled straight from the USDA Nutrient database.

You can take a look at the nutritional benefits of things like ham, hamburgers, turkey, cold pack American cheese, hot dogs, and compare those versus tuna, and what you will generally find is that on a whole host of major health benefit attributes, tuna outperforms them.

What you see there is everything in yellow is a value that is worse from a nutrient and health standpoint than tuna.

DR. MILLER: Mr. Stiker, could you summarize.

MR. STIKER: Yes, I can, sir.

Our conclusions. At the time that the advisory was issued, we perceived there was no immediate health risk from methylmercury, no U.S. consumers were even close to the Faroes NOAEL.

There is no new data since NHANES that suggest you need to make the advisory more

restrictive. On the contrary, there is substantial data that the March 2001 advisory had a dramatic impact on seafood consumption by pregnant women, perhaps even swinging the pendulum too far.

The advisory is a blunt tool. Even carefully phrased language of moderate is often taken by U.S. consumers as cease. The data suggests that the curve has changed since the

1999-2000 NHANES. Further data suggests that pregnant women are being driven to alternatives to canned tuna, which pose their own and different health concerns. It is not risk free.

Our perception is it is not proven at this point to make the advisory more restrictive. It appears to be working. It is doing what you want it to do, and the impact of driving down seafood and canned tuna consumption further brings other real health risks.

Our recommendations. Continue combining the FDA and EPA advisories. We think that is terrific to minimize confusion. Given the extremely low levels of seafood consumption by U.S.

consumers, we think there is room even for a more positive tone in the advisory to actually encourage more seafood consumption by the vast majority of U.S. women who aren't eating enough.

Definitely include the caveats that are currently in place - 12 ounces a week, ensure a variety, eliminate the high-end species. We believe there is no health-based reason to make the advisory more restrictive even implicitly. Only call out canned tuna if you are really comfortable with the health implications of moving more pregnant women to deli meats, baloney, hot dogs, cheeseburgers.

If you still feel you must call out canned tuna, please, do it in a responsible way that assures consumers that both albacore and light meat are extremely safe, and follow up to the NHANES data with current data to assess the impact of the advisory.

It is hurting the seafood industry, but that wasn't I am sure your intent, nor is it something that you should be terribly concerned

with. Public health is what you are here for. But I can tell you it is having an impact and it is working.

That's all for my formal presentation, but I am happy to take questions on that or the appendix that is included, as well.

DR. MILLER: Yes.

MS. HALLORAN: I have two questions. The first, can you tell us the relative omega-3 content of albacore versus light meat, is it the same, or is one higher than the other?

MR. STIKER: Yes, ma'am, I can. In fact, if you go to page 7, you can contrast canned albacore versus canned light. It is about almost 4 1/2, 5 times more omega-3 in albacore than there is in light meat.

MS. HALLORAN: The second question would be if the advisory were to state that pregnant women should avoid albacore, but the advisory positive encouraged them to eat more light tuna, or indicated that light tuna was safe to eat, what would the impact on the tuna industry be of that in

rough terms, or can't you speculate?

MR. STIKER: I would be happy to speculate. First, I will attack it from kind of a public health standpoint. I think there are some consumers who would shift their purchases from albacore to light meat, which would bring with it concurrent reduction in omega-3 intake.

I think there are some consumers who are albacore loyal. You will see in the appendix, there is a picture of what a can of albacore looks like versus a can of light meat, and it is a very different quality product.

Personally, I am an albacore eater and I am not a huge fan of light meat. I would switch to lunch meats, hot dogs, cheeseburgers. Then, I think there are a fair number of people who will not take away the message of, hey, light meat tuna is okay, but albacore is more concerning. I think they will take away federal warning on tuna planned, and simply stop eating tuna altogether.

Anecdotally, my sister-in-law is pregnant. She knows I work for a tuna company. She told me

she has stopped eating tuna altogether. She only eats it once or twice a month, and she has stopped eating it altogether because she has been hearing so much about mercury in tuna. That breaks my heart, not just as a business person, I mean it is good for her pregnancy, it is good for her fetus. She should be eating tuna.

DR. MILLER: We will take one more question and then we have got to break.

DR. APOSHIAN: I have an 2002 annual report of the United States seafood industry, and on this it claims that of all the tuna landings by U.S. vessels between 1992 and 2001, for the year 2001, albacore was only 12 percent of the tunafish caught. So, how can it be a great catastrophe if albacore consumption went down? You have still got all the other tunafish.

MR. STIKER: You are actually comparing kind of apples to oranges there I believe there, sir. I think what you are comparing is landings by the U.S. fleet, which only comprises a small portion of the overall tuna fishing fleet in the

world.

The data that we are looking at is U.S. consumption. So, U.S. consumption is closer to about a third that is done in albacore, not the 12 percent, sir.

DR. APOSHIAN: So, essentially, if albacore was not sold, it would not hurt the U.S. fishing industry.

MR. STIKER: Correct, which is a very small proportion of the overall world fishing fleet located primarily in the western Pacific fishing for light meat product.

Yes, sir.

DR. MILLER: I made a mistake. We have one more speaker. Thank you.

MR. STIKER: Thank you.

DR. MILLER: We have one more speaker and then we can break for lunch.

Dr. Lillian Beard.

DR. BEARD: Thank you and good afternoon.

I know the hour is late, I will not be taking very much time. As you know, as you have

just heard, I am Dr. Lillian Beard, and I have no financial relationship with either agency.

I have been practicing pediatrician in the Washington metropolitan area now for about 30 years, and I am also an Associate Clinical Professor of Pediatrics at the George Washington University School of Medicine, and an Assistant Professor at the Howard University College of Medicine.

I am here today to address my concern that the mercury advisory may in fact be hurting more than helping pregnant women and women who might become pregnant and could have an adverse effect on their young children.

As has been mentioned a few times earlier today, a Harvard Medical School study published in the August 2003 Journal of the American College of Obstetrics and Gynecology, entitled "Decline in Fish Consumption Among Pregnant Women After a National Mercury Advisory" concerns me greatly.

The study showed that after reading the advisory, women who were consuming 2 to 3 servings

of fish a month reduced their consumption to only 1 to 2 servings a month. Remember that many organizations including FDA and the American Heart Association have recommended 2 to 3 fish servings a week.

These statistics alone tell us that women are not consuming enough fish if they are only eating it 2 to 3 times a month, and if they have cut that in half, it should sound an alarm.

While the study was limited to the eastern part of Massachusetts, it, nonetheless, raises the question of whether this is a trend nationwide, in which case we should all be very concerned.

A reduction in seafood may be appropriate if individuals were close to the 12 ounces a week recommendation from FDA. However, market surveys continue to suggest that households are purchasing less than 6 ounces of seafood a week for the entire household, not just 1 individual.

As Mr. Stiker pointed out, according to the Department of Commerce, there has already been a 10 to 15 percent reduction in the consumption of

canned tuna over the last two to three years. Canned tuna is not the number one consumed seafood, shrimp is the leader, yet, the focus continues to be on tuna, which is by far the most economical means of providing a nutritional protein source for families, as well as being the second leading source for the omega-3 fatty acids.

As a pediatrician, I do follow the guidelines established by the FDA, and I advise and counsel my parents accordingly about the importance of healthy diet and the need to eat a variety of foods including fish.

I encourage my parents to include fish as part of their children's balanced diet and I discuss the health benefits for them and their children from eating fish. In my counsel to parents, I emphasize the importance of variety and appropriate portion sizes based on the child's age and size. My approach to diet and health has been to consider always balance and moderation.

Young children already consume less seafood than adults. To make separate comments

about this may unduly scare parents into not serving seafood at all. In the NHANES study, there were no children who exceeded the reference dose.

I am concerned that we may be pushing mothers and women of childbearing age away from a safe and beneficial food, such as fish, including canned tuna. When advisories are difficult to interpret, they seem more confusing than helpful. The benefits of the omega-3 fatty acids for eye and brain development of a baby are very important. Pushing women away from fish which provides them with this essential nutrient would be detrimental.

Our zeal to protect women may in fact be doing them and their babies a disservice. I encourage you to provide the public, especially health professionals, pregnant women and women of childbearing age with simple, eat to understand guidelines that help us to understand the important benefits received from eating fish, and not just the scary concerns.

This past summer, the United Nations World Health Organization gathered experts from around

the world to evaluate the most recent information available on mercury and its neurodevelopmental effects on children. They recommended establishing a safe daily intake level that is twice that of EPA. Are we supposed to ignore their advice? Does it not have some relevance to the current review that is going on?

In conclusion, I commend both the FDA and the EPA for attempting to provide one message rather than two and I sincerely hope that you will be successful in persuading the states to follow your lead, so that we ultimately hear one message, and not 52 messages.

Thank you for your time and your attention.

DR. MILLER: Any important questions or comments? If not, thank you.

That brings us to the end of the public comments. We are going to break for lunch now. It is now quarter past the hour, I am going to ask you to try to be back here in 45 minutes, and then we will start discussions on each of the topics to see

if we have any advice to offer to the committees.

[Whereupon, at 1:15 p.m., the meeting

recessed, to reconvene at 2:00 p.m. this same

day.]

A F T E R N O O N S E S S I O N

[2:00 p.m.]

FAC Discussion and Comments

DR. MILLER: We have got a busy afternoon ahead of us and I have tried to clarify some of the responsibilities we have under the charge to try and simplify our work.

There is very little we have to do with the reports from the subcommittees that we talked about the first two days. Unless there are some significant changes that we think should be made, the subcommittees will get copies of the transcripts and some of the other recommendations made, which were stylistic ones, will go the committees and they will make whatever changes need to be made.

But if there are no major differences between the subcommittee report and our thinking, I would just like to accept these for the record in saying that the full committee has reviewed the report and has referred it to the Center Director for him to take action on the report.

I really appreciate that. That allows us to go right to the methylmercury, which was a direct referral to this committee. As you all know, this was the second time that this committee has had a chance to review the agency's, and as you also know, there were 6 recommendations made by the FAC, of which 5 were reviewed and developed by the two agencies involved, the most important one being that FDA and EPA work together to develop the advisory.

The one area that did not, and I don't propose that we start discussion of it here, but just for the record, had to do with development of blood levels and the biomarkers for mercury. I would like to be able to refer that back to the agencies involved and repeat again that we think it is important for us to develop that data in order for us to tell what the biological consequences are of exposure to levels we are talking about.

The other recommendations all have to do with the advisory, and there are a number of recommendations made by the various speakers, and I

asked Jean Halloran if she would take the opportunity to make a very brief summary of some of these things.

Much of what we talked about were in the materials submitted to the committee, we don't have to review that. I would like to focus on those important things that we want to tell the agencies that they ought to do, and I have asked Jean if she would make a brief note of what some of these things might be.

MS. HALLORAN: This is a very intimidating task, but I will try and summarize our discussion, the points that were raised so far. That is what you want me to do, right?

DR. MILLER: Exactly.

MS. HALLORAN: In the discussion of the FDA exposure assessment, there wasn't much criticism or problems raised. Dr. Aposhian brought up this very interesting study of Holmes, et al. on autistic children. We had a discussion about whether there might need to be a special message for groups, this group and other groups, who might

have a special situation.

In the discussion of the focus groups, we agreed that this is a widely-used research tool on perceptions and that it was agreed that

African-Americans were included.

Dr. Scherer raised the interesting point that the real issue is how understand and perception translates into behavior, and asked if there were any follow-up plan. They didn't say that they directly planned specific follow-up although they would do some surveying.

We then proceeded to the presentation on the advisory, and this is where the most interesting points, the largest number of interesting points were raised. I will just go through them chronologically from my notes. This is not in any order of importance or logic or sense.

It was pointed out that mercury is an element. There was considerable discussion on and off about portion size and that the portion size matter is still confusing in the advisory and just

generally as an issue.

It was mentioned at various times should there be information on what consumers can eat. That information is not there. The issue of verbiage was raised, and the countervailing suggestion that the Ten Commandments is considerably more brief and covers more ground. This came up numerous times in numerous ways, though.

The question of should there be special messages for the poor, for special type relations, such as Asians came up. The order of the points and the primacy effects was pointed out.

The point was made that perhaps we need simple behavioral rules, and the Minnesota document was given u=as a good example of simple behavioral rules, also that not all consumers are the same and need access to different levels of information.

The problem of names of fish came up again and again. Fish don't all have the same names and especially for the top four problem fish, we need to have all the names that they might go under,

their aliases.

The issue of what happens to the rest of the family as a result of dietary advice was raised, also, should there be a role in communication for food stores and restaurants and cafeterias.

I think that is about it in terms of the major points. It is not everything, but those were the ones that came up to me as major points.

DR. MILLER: Thank you, Jean.

Any comments?

DR. ALLER: I will make one, and, Jean, I think you did an absolutely fantastic job, because I had done something kind of similar on my own, and will add just a couple of points to it.

I think that what we have been looking at, if we start with the starting point that the FDA has said and agree that the majority of the population is indeed okay, that this message is being crafted to improve on that smaller portion of the population for which the risk exists.

Then, from there on, it starts to get a

little touchy because that population is not all uniform and we have heard from a number of the speakers representing various different constituencies, be it cultural or economic basis, or what have you, about what that message may need to be and how best to target it.

Kind of what I gathered from all of this is that certainly, for a segment of the population that we are trying to reach, we would need to be saying it's okay to eat fish as much as you want in this low concentration or this low-risk group, and to provide that information.

I am not saying that that information needs to be provided to everyone, but that information does need to be available in some way, shape, or form for certain individuals or certain target groups.

I think that in terms of message delivery and how that is done, certainly, the advisory that was crafted was well thought out, there was a lot of input from the public, and it certainly is appropriate for at least one portion of this group

that is the target audience.

There may, however, be other mechanisms and better ways to address other segments of that population, and the behavioral model that we had handed out, which certainly is an action item, this is what you need to do in a simpler format, and providing a list is yet I think another means to successfully communicate. We just need to make sure that the message is consistent among the formats.

I think it came up both in our meeting a year and a half ago and again today, there is a great deal of confusion amongst species, and I am not sure that the advisory can address all of that issue. That, I think, is a much greater issue and extends far beyond this. But I think where possible, tilefish, I remember from our prior meeting a year and a half ago, the question we all are asking what the heck is a tilefish.

I just for grins went on the Internet Monday and just typed in tilefish to see what I came up with, and sure enough, there are lots of

different species and different names for different things, and I am not real sure of those, which are or are they all being targeted. So, I think that point particularly raises some confusion and it may be if cod or halibut has very similar types of things. I always thought that cod was cod, but this is my ignorance.

So, I think that some of those are also issues of great concern.

The issue of the first and the last message I think is also a very important one, and I don't know that we have reached agreement or consensus, but if the three points are

indeed--there are good things, here are things that you can do to limit your risk, and those are positively stated, and if there is something for which we want to ensure you don't do, I would make those our first and last points, and that gray area of a variety or what have you more in the middle, so that again we are stressing those beneficial fish, high in omega-3's and lower risk in mercury.

I think that about sums it up, so I will

hush.

DR. MILLER: Thank you very much.

DR. BUSTA: I fully agree with the first two comments, I think they are both covering areas. One additional item that I thought came up, or at least I was thinking of, is the idea of multiple advisories separated by the target groups.

I think it is wonderful to have one message from two agencies. That, I think is magnificent because at the last meeting, the confusion between what EPA and FDA said is really bad. I like that one message there, but I think that, depending on the targeted group, several messages have to be developed because without an additional message for old men like me or things like that, the simple message for pregnant women and children is going to carry across so that it won't be differentiated. If you offer several advisories, that may enhance the differentiation.

DR. ACHOLONU: With respect to names, it was stated that certain fish have different names depending on the population or the section of the

country you are coming from.

One of the speakers suggested that what will help here is putting the names, getting the scientific name, put it in parentheses. A scientific name is a scientific name and is very specific, so that we know the kind of tilefish we are talking about, because somebody that talked about tilefish, they thought about snapper and the rest of it.

You may include the common names if you want, 1, 2, 3, but then at the end, in parentheses, put the scientific name of the fish, and I think this would be helpful. Thank you.

DR. MILLER: Thank you.

Dr. Lund.

DR. LUND: Just two other points also on things that we talked about or came up during the discussion with the FDA staff and others who were presenting. One was the issue of eating a variety of fish, to what extent that is necessary and is helpful in limiting the amount or exposure to methylmercury.

The other issue that I thought came up during that earlier part of the discussion also was how specific we ought to use quantitative data in here, in other words, going back to a body weight basis particularly I think for children more so than for the women or nursing mothers.

DR. MILLER: Thank you.

Dr. Russell.

DR. RUSSELL: Just to second what you just said, I think the serving sizes for children has to be explicit as was suggested by one of the speakers.

The other thing that I think I have come to believe after hearing more and more and re-reading the tuna guidance, I think the tuna guidance, as it is written now, is pretty unclear of what is good and what is bad. I mean you have to read it pretty carefully to be able to ferret that out.

Finally, this doesn't really have to do with the advisory per se, but it has to do with the continual need for testing of not only more fish,

but more samples of the fish we have. If it is true, as one of the speakers said, that there is only 6 analyses of shrimp, which is the number one eaten fish, I think that is much too few to make any kind of any statements with, and I just think we need a lot more data.

I am almost wondering whether, at this point, it would be nice for EPA and FDA to come out with a joint advisory, but I think it has to be a moderate change from what we already have, because we are missing so much data still to come out with any kind of thing that is more definitive or complete.

DR. MILLER: Thank you, Dr. Russell.

Dr. Nelson.

DR. NELSON: I would also like to thank you, Jean, for distilling all the commentary down so effectively. Following up on Marion's comments about the order of the message, I think that is particularly important because of the consistent message we heard at different levels about unintended consequences of this kind of warning or

advisory.

FDA and EPA considered that clearly in the design of their initial advisories and their work with the consumer groups, focus groups. Dr. Downer mentioned it in her practice, and we heard from a couple of other speakers about that, as well. Part of the challenge is to make sure that a balance is struck between protecting against potential risk of methylmercury and the good dietary and nutritional contribution that fish makes.

DR. MILLER: Dr. Scherer.

DR. SCHERER: I clearly come at all of this from a slightly different point of view, maybe a major different point of view than most of you.

I sometimes get accused to stepping back and trying to look at the bigger picture more often than I probably should, but it seems to me that if I think about what this whole process is about, you know, the agency is responsible for collecting good data, providing sound conclusions from that data, and ultimately protecting the public's health.

From what I think I have heard, and

ultimately, I am getting to my level of expertise, is that I have heard that there does need to be more data. I guess part of my message is that I don't see this as an end product, that we arrive at an advisory and that's over, that there needs to be continuing collection of data, but it seems to me that the data that is within my area a little bit more, that is clearly still missing here is consumer consumption patterns, that we don't know about those subgroups that ultimately would become the targets of the advisory.

Now, that is clearly difficult data to collect, but it seems to me that it is very critical data to really be able to target messages to people that are either high fish-consumption groups or minority groups that consume particular kinds of fish in higher amounts than the average population.

When we go beyond that and we assume that we have good data, and I think at this point, obviously, there needs to be some thinking about do we have good enough data to go on, and think I hear

the conclusion is yes, we have to go on and do something.

It seems to me that the agencies--and I say "agencies," EPA and FDA--have made real strides in beginning to put together a relatively--a sound message. I congratulate them on the use of focus groups to help design that message, but they need to keep in mind that that is only the very first step, and the next level needs to really be understanding of what is it that people are reading in that message, what do they remember from that message, and what kind of action might they take as a result.

If they are coming away from this message saying I am going to stop consuming fish, then, that is not what the data would support, I think. There needs to rethinking then of what that construction is.

The warning that I would have is that the use of focus groups in constructing messages can be very helpful as long as we don't let the focus group control the content of the message, and even

if they say I don't understand this particular aspect, that doesn't necessarily mean it should be thrown out.

So, I am a little concerned that the message may not be reflecting the kind of science that is behind it to the extent that the consumers will come away with the same kind of conclusions we want them to.

The final one, and I think Jean mentioned it, is the idea that we really need to be clear in terms of presenting specific kinds of behavioral steps that individuals can take. We all operate on the simple rules, and without those simple rules, the first point, don't eat these fish, is likely to be what people come away with would be my fear.

So, I think there is still a lot of work to be done even when the advisory is ready to go at this stage.

DR. MILLER: Dr. Heimburger.

DR. HEIMBURGER: Yes. I want to lend my voice to all those who have said--I think essentially, I would be uncomfortable with rushing

to implement a revised advisory especially if it were a major revision to what was already out there.

I think I heard enough that made me think that more harm could be done than good by making a major change, and it seemed to me that the message that we were hearing this morning sort of could be coalesced into four major categories.

Number one, there needs to be a better science base. Some of that relates to the testing of fish more, maybe sharing data with industry or receiving shared data from industry, increasing the species detail with regard to the data, and then also, as expressed by the person from Harvard, assessing better what really would be the net effects, what are the net effects so far of the advisory and what might be the net effects of revision, because it seems as though the science base on all those accounts is not what it could be.

Second, to make sure that the positive message is very strong. This came through again and again from a number of different people who

testified, and I think we all ought to be concerned that the net effect could be one of reducing potentially the overall public health by turning people away from fish in an unintended manner.

The third would be to create maybe a hierarchy of recommendations. The high, medium, low concept in terms of methylmercury appeals to me; stay away from these, choose these, that maybe somehow the positive and negative messages can both be embodied in that.

That makes me think that the idea of either encouraging a variety of fish consumption or mixing it up is not helpful, and I would think that actually might need to be struck from the advisory entirely. I think there were some pretty compelling scenarios shown whereby that might actually have an unintended negative effect.

Then, finally, to the fourth general category was to refine the populations that we are looking at, perhaps separate advisories, definitely separate recommendations for children, consider high-end consumers, as well, a bit more robust

definition of what the populations are.

If anything--I am new to the process, so I don't know exactly why several of the speakers have said we need to do something quickly--I am more prone as a newcomer to the process to say why are we compelled to do something additional to what has already been done quickly, and it seems to me that perhaps that caution would be the more prudent approach.

DR. MILLER: I think in terms of the latter issue, it is pretty straightforward that there is a general and increasing belief that there is a public health problem that needs to be resolved, the consequences of this could be dramatic, and there is a role for the agencies to play in that public health aspect.

I think the agencies agree with that. I think that what we need to do is to come out

with--there are a couple of things--one, the agencies will review the transcript of this meeting, and not only those things that we point out especially need to be looked at, but all

comments will be looked at for advice to them about what to do.

What I would hope that we would come out of this with is not simply to repeat that--Jean did and Dr. Aller did wonderful jobs in summarizing that, but I think that if we can come up with a short number of general recommendations, for example, that the agencies need to develop a much larger and much more effective research program on several areas in terms of concentration of methylmercury in fish and agreement on the speciation of fish, and so on, that is the kind of recommendation we need to make, and the fewer of those, the better, that are more likely to get attention.

Dr. Downer.

DR. DOWNER: I won't belabor the points that you have already made, because I think we all are in concurrence. I just wanted to bring a little bit of light onto some additional issues.

Based on some of the data that we received today, it appears that some additional fish may be

needed to be added to this list, albacore tuna for one and halibut. Those are at higher levels than we had, at least I had first thought.

With respect to the portion sizes, USDA uses 3 ounces of the standard portion size, and perhaps when we talk about portion sizes, maybe that is what we would want to look at, 3 ounces rather than the 6 to 8 ounces of whatever the nebulous number that we are actually using at this time.

With respect also to providing information for the different groups, I think the physicians, clinicians, and other health care providers who provide information to John Public should have some material provided specifically for them, as well, so this can serve as a resource for the public, because that is important, as well.

DR. MILLER: Thank you.

Dr. Dwyer.

DR. DWYER: Thank you, Dr. Miller.

I am a little worried about the best being the enemy of the good or the better, and wanted to

congratulate EPA and also FDA for what they have striven to do in the past year or two since we last saw this.

It really has been an enormous effort and I think sometimes we get in to the niggling details without saying that this approach of modeling I think is a good one and the question is the model is always the issue, and I will come back to that in a moment.

In terms of the draft that is now available, is that likely or could it be posted on the web for comment? I am sure the answer is no, but basically, that would be one of way of keeping this evolving process going forward.

My other suggestions have to do with the--

DR. MILLER: Wait a minute, before we go any further, Johanna, I want to know if there is somebody here that can talk to that. David?

DR. ACHESON: As a relative newcomer to the Federal Government, I would say anything is possible, but that is probably not realistic. I think if that is a recommendation, Dr. Dwyer, that

you feel is important, we would certainly take it into consideration.

I mean we are looking for comment. On the other hand, we don't want to take forever, because we believe we have an important public health goal.

DR. DWYER: The reason I think it is important is this, that I think this is an improvement over what is up there now, and I have been developing, with many colleagues, advice for pregnant women, and kept telling people to go to the web to find what I thought was on the web from what we did two years ago, and nothing was there.

So, at least from my standpoint, it is a recommendation, I don't know if the committee shares it, but basically, we have done a lot of work, all of us, and we are making progress. We don't have something that is perfect yet.

DR. ACHESON: Just so I understand what you are recommending would be that the current draft advisory be posted for comment?

DR. DWYER: I am. Even though I have told you many, many things I think is wrong with it, I

think it is better than what the current advice is.

DR. ACHESON: So, post it as a draft.

DR. DWYER: Oh, absolutely.

DR. ACHESON: As a draft for comment.

DR. DWYER: As a work in progress, which is a little better than what is there now. That's all.

DR. ACHESON: Okay.

DR. DWYER: The second issues has to do with the table.

DR. MILLER: Dr. Acheson, thank you.

DR. DWYER: One has to do with this whole issue of nailing down consumption patterns of infrequently consumed foods that may be of a problematic nature or perhaps of an enormously beneficial nature, and that gets to these fishes.

Again, I am delighted that you are thinking about doing, but I would recommend specifically that you try to get better estimates of consumption by continuing to refine the questions that are being asked in the HANES survey. As you know, HANES now is doing 5,000 people a

year, so over time it really does develop into the kind of samples sizes where you can do cuts by three or four different things and get to specific subgroups, but it takes time.

The items right now for foods that are not very frequently consumed are a problems. There are ways--people at NCI have worked on this propensity questionnaire, which are lists where they get some idea of consumption over 30 days, that are more specific.

Of course, we would have to have the common names, as well as the names that some of us don't, know for these fish that we are eating. So, I would urge that that be done. Maybe HANES isn't the best place to do it, maybe it's MRCA, maybe it's some other place, but the idea is to get better consumption data.

Dr. Russell mentioned getting better data on the methylmercury in the fish because you need food, as well as consumption, to get food consumption. I would urge private sources, state sources, whatever sources--food-composition

analysis is very, very expensive, so if the data are out there and they are collected already, why go to doing the analyses yourselves.

The third thing is blood levels and the variability in blood levels, so that diet can be related to blood levels, and that is one thing that HANES can do for you, and there may be some others, I don't know.

Finally, continue to develop models and refine them, and specifically when people get into risk-risk, benefit-risk, whatever, we really do have to look at every assumption. We have to look at sensitivity analysis because each assumption can make an enormous difference in what is going on there.

I know people know it, but I am just trying to get it into the record that any analysis needs to have all of those things.

DR. MILLER: Dr. Krinsky.

DR. KRINSKY: I used to get questions as an undergraduate, compare and contrast. Some of them, one could do that, but, you know, compare and

contrast Chaucer and Saul Bellow is impossible. So I thought I would compare and contrast the 2 1/2 year old advisory to the present potential advisory.

The 2 1/2 year old advisory has three points just as this one has. The first point is, to protect your unborn child, do not eat shark, swordfish, king mackerel, and tilefish is the same.

The second point was, you can safely eat 12 ounces per week of cooked fish, and now the present one talks about 12 ounces of purchased fish. Now, we know that there is some difference between cooked and purchased, so whether that is an improvement or not, I am not clear at all.

Also, the second point 2 1/2 years ago was that a typical serving of fish is 3 to 6 ounces, and now it's 3 to 4 ounces, so they have cut down the size of each serving.

The third point was--this is the old

one--there is no harm in eating more than 12 ounces of fish in one week as long as you don't do it on a regular basis, and the new one, I am sorry, I

repeated that.

The third one is check your local advisories. They had the same thing in both of them.

So, in those three points, there has really been very little difference in the original FDA advisory and the present one, the joint EPA-FDA advisory. What has been added now is the tunafish, and I agree with Rob Russell that that is sort of ambiguous in terms of the quantities that are allowed.

So, the changes, as far as I can make out, have not been large changes, and yet it has obviously caused us to have a full day of discussion. I think what is important to me is the information that appeared at the end of this morning's session from the public organizations.

The one point that seems to stick with me is the 12 ounces of fish, cooked or not cooked, and whether, in fact, that is safe. I am not clear after listening to the presentations this morning that 12 ounces of any of the selection other than

the 4 that are proscribed would be a safe level.

So, I am very concerned about having that in the advisory as it is now.

DR. MILLER: You mean the tunafish?

DR. KRINSKY: Of any of the fish, because we did hear presentations indicating that 12 ounces of a variety of the fish that had been evaluated for their mercury content could regularly lead to levels of mercury consumption that would be above the RfD.

DR. MILLER: The problem, just to raise the issue--the problem is that there are some positive virtues of the consumption of fish that have to be taken into account, and that is part of, I think. the risk-risk analysis that needs to be done.

Without that, I think the nature of the risk process allows you to do this if you recognize what the potential hazards are.

Jean.

MS. HALLORAN: If I could speak for myself now, instead of the group, I very much agree with

what Dr. Krinsky just said, and what I think is important to realize is that the 12 ounce is--from Carrington's analysis, the 12 ounce is okay if you are eating low mercury fish, but not if you are eating medium mercury fish.

Now, I took a look at the low mercury list that he was working with and compared it to the fish that are consumed by the public, and if you take the top 10 fish that are being eaten by the public, they are all on the list of low mercury fish except for albacore tuna.

So, you could easily construct an advisory, just change a few words in what has been written here, and significantly change the import of it. Instead of saying you can safely eat 12 ounces, say you can safely eat 12 ounces of low mercury fish, which include--and then list the top 10 or even the top 5 - shrimp, salmon, pollock, catfish, cod, to take the top 5, and add shellfish, and you pretty much have it.

I also really think as a committed fish eater, that there are tremendous advantages for

eating fish, and people should not be discouraged from eating fish, but the only way, if you have a message that just says don't eat without a part of the message that says here are some you can eat, that you are going to discourage people.

If you want to have a two-pronged message and make it clear that all fish are not the same for pregnant women, then, you have to have a positive list, as well. So, that would be my main recommendation, that in the advisory, that fish be named, the low mercury fish be named by name.

Then, just a couple of other things. I agree that we could make a recommendation to have an example of body weight and serving size for a child, to make that clear. I don't think that is obvious to many consumers. It is too much arithmetic.

Then, thirdly, where it talks about tuna, so you could safely include light tuna as part or weekly fish consumption, because that is what the science supports. Thanks.

DR. MILLER: Dr. Durst?

DR. DURST: I would like to get out of the chemistry path and comment on some of the information that these recommendations are based on, the analytical data. I am not sure how these data were evaluated, whether the literature values from various studies over the years were just accumulated and added together or whether there was actually a critical review performed on how these data were acquired in terms of the methodology used, the protocols, whether you are measuring total mercury, or methylmercury, or what species in particular.

So there are a lot of possibilities for introducing a lot of the variability I think we see in the data that have been acquired over the years.

I would like to suggest that if EPA or FDA sponsors any studies in the future as far as trying to apply these data for the advisory, that a strict protocol be provided to the contractors to follow so that we do know that we are measuring the same quantity and can have a little more validity to these data.

Thank you.

DR. MILLER: Any other comments? Dr. Waslien?

DR. WASLIEN: I just made a list of what things one should look at. The list became long but I was concerned that on the RfD selection process, if that isn't also something that should be part of the ongoing research agenda, that one also makes sure that the NHANES data on blood levels be compared with risk of effects from it. If you are going to be doing a risk assessment and benefit assessment comparison, that should be part of the equation, too.

DR. APOSHIAN: I remember that at the end or during the last meeting, it was suggested by a number of people that since the tunafish industry analyzes every batch of tuna that basically goes into a can for mercury, that the FDA might want to consider looking at that data. If the analysis has been done by an approved lab, under certain conditions, it would better than no data.

I think it was the president of the Tuna

Association that told me during the last meeting that they had this data, and I think he told me also they would be glad to share it. I don't know whether the FDA would want to depend on such data, but when you think about clinical trial of drugs, the FDA's drug approval group, whatever it is called, accepts data from the pharmaceutical companies if they have compiled the data and have done the analysis.

So, there might be a bank or a reservoir of data that is available, and I would recommend that we ask the FDA to look into that. That is number one.

Number two, I am just a poor country boy, I just teach and do a little research, but from what I know about industry, I think, is that if industry had this problem of coming out with an advisory, they would hire experts who know how to write advisories. They hire communication experts. The FDA, I know hires all sorts of consultants and contracts all sort of work and I wonder whether we could recommend that for the fish advisory, that

they bring in some kind of outside expert to help them put together an advisory that might be more acceptable.

Third, I am very concerned about the albacore tuna, and I hope that--I know that maybe this may not be the time--but I hope, Mr. Chairman, we will get back to the question about what do we do about albacore tuna.

Thank you.

DR. MILLER: Why don't we discuss albacore now if we are going to discuss it.

DR. APOSHIAN: I didn't see anyone disagree about the analytical results as far as the amount of mercury in albacore tuna as compared with other fish. Again, I don't do shopping in my household unless my wife is sick. She had broken her ankle, so I stopped by the tuna shelf in the local market, and albacore, I saw it, because I was never aware of it before the last meeting. So I saw it and said, it doesn't even say tuna, it says albacore.

You know, I am supposed to have a Ph.D.

and M.S., and I didn't do know that, that albacore was tuna or is considered to be tuna. There seems to be some need, again, of educating the public about what albacore is. I do studies all over the world, and every time I see sick children who are exposed to arsenic and mercury, whatever, I feel very badly and can't help but relate them to my own personal background, namely, my grandchildren.

I certainly, at the present time--well, I have told my granddaughter who is of childbearing age, which I hope she won't have one for a long time, that she should be very, very careful about the tunafish that she eats, that she should probably have one sandwich a week, which is plenty, and I also told her just the other day when I was in Boston, that she shouldn't eat any albacore. But I have told her she should eat fish, and that fish is very, very good for her, and that message gets across.

It gets across probably because I make a point of it, and so I am asking whether the FDA could make a point of getting experts to get that

message across, because I certainly would hate to think--I don't like the idea of American children or American pregnant women or women of childbearing age eating a lot of albacore. I think that should be a very important part of this discussion.

I know we are going to have to make compromises on tunafish and other things, but the albacore seems to me--as a toxicologist, seems to me to be a potential source of danger, but there are nutritionists here who can talk more about that.

DR. MILLER: Jean.

MS. HALLORAN: This also raises the question of what should be on the Do Not Eat list, and there doesn't seem to be a firm criteria for how something gets on that list or possibly gets taken off it. I think that we have seen from

the--if we can ever figure out what tilefish was, we might be able to determine that with new data, perhaps it doesn't have as much mercury as was initially thought or perhaps there is some subspecies of it that does and that subspecies or a

particular local variety could be identified.

On the other hand, we have pretty much confirmed that albacore tuna is high and grouper and orange roughy aren't looking very good. They appear to be higher than the tilefish.

So, perhaps a recommendation could be to FDA to establish a criteria or cutoff for what goes on the Do Not Eat list and to revise that list periodically as data comes in with serious consideration as to whether albacore tuna should be on the list.

DR. MILLER: Well, that would apply also to the moderate levels, as well. In other words, if you are going to make a list, you need to have criteria to decide on which of those lists things go. It is not just the high-dose fish that we have to worry about. We have to worry about the fish with moderate doses, as well, too, the ones that you are effectively saying you can eat it, but don't eat it too frequently.

MS. HALLORAN: Although at the moment, I don't believe that exists as a public list, does

it, the middle list?

DR. MILLER: It is not in the advisory. The advisory just has the Don't Eat part of the list.

DR. ACHESON: The high, medium, low criteria were in the directions to the peer-review group.

MS. HALLORAN: My understanding is that there is data that say high, medium, low, but I don't recall FDA giving any instructions on how much you should eat from the medium and low groups.

DR. MILLER: David.

DR. ACHESON: Yes, just to clarify that point, the data is on the website. The high, medium, and low, for the purpose of the exposure assessment, as Dr. Carrington mentioned yesterday, were arbitrarily chosen to put light tuna in the low category. So essentially, the 0.12 was the cutoff for that, and everything below went low, and everything above went medium except for the 3 high, in fact, because he didn't use tile fish in the model.

DR. DICKINSON: This is just to reiterate the point that was already made about the need to clarify the reasons for classifying things in different places, because if we are talking about adding albacore tuna to the list of Don't Eat things, it actually, on their list, is not at the top of the middle mercury category, and is not that much above the couple that are just below that.

So, I think there would need to be a reason for selecting the cutoff, and some uniformity about what was on the list.

DR. APOSHIAN: It might be the idea of consumption, that they probably eat more of that than some of them above.

DR. DICKINSON: That may be true, but we don't have very satisfactory data from NHANES as to whether tuna was figured largely in the individuals who were at the top of that distribution either.

DR. DWYER: Do we know that? Do we know what that top 5 percent ate?

DR. DICKINSON: No.

DR. DWYER: It wasn't in HANES anyway, was

it?

DR. DICKINSON: Yes, it was, the 8 percent was.

DR. ACHESON: That was part of the problem is that we really don't know what those 8 percent ate, which is what I said earlier this morning, that that is part of the goal is to figure out who they are and what they eat, so we can develop a targeted message toward them.

DR. DICKINSON: But we don't have information now to say it's tuna.

DR. ACHESON: No, we do not.

May I just make one other comment in relation to that, and that is, in terms of the exposure through market share versus the amount an individual consumes, because obviously, the critical issue is how much is on your plate.

We know that a portion of albacore may be no different from a portion of salmon. The critical issue would be, as we know from the data, that there is a lot more albacore consumed, and tuna consumed, than there is salmon. So I think

that if we are going to try to set criteria for high and medium, we have got to define that very carefully.

DR. MILLER: That is reasonable. That doesn't necessarily take away from the fact that this could be very useful.

DR. ACHESON: I agree, it could be useful if it could be done, yes.

DR. MILLER: Dr. Aller.

DR. ALLER: I think that point gets back again to our definitional issue of what do we mean by high, are we talking about high risk, are we talking about high concentrations, and when I talk about risk, I am thinking not only of concentration but frequency of consumption.

I think as we talk amongst ourselves, we need to be keeping that clear in what we mean and in our advice back to FDA and EPA.

DR. MILLER: Dr. Callery.

DR. CALLERY: Thank you. I think we have often now looked to a scientific basis for what we are making our decisions on here, and it looks like

we are not having a good definition of what makes the list and what doesn't make the list, and where it fits on the list.

I think that that becomes even more difficult in the process of saying what is the criterion for putting an item on the list for the advisory or off the list for the advisory.

I think there is a negative impact to the public to change your mind after a while, and you ought to have a very good criteria set up to do that. I know, at least in my neighborhood, there is a distrust of scientific information. The concern is, you told me I could eat it, and now you tell me I can't. Can't you make up your mind?

So, I think to do that kind of idea of saying you can take it off the list at some other point, you had better have a really good rationale and criteria established ahead of time rather than you will figure it out later.

The issue about albacore, of putting it on the list of banned ones would be I think a very confusing thing for the public because some people

think of tuna as tuna, and I that it would be difficult to say, well, this one type of tuna is banned, but this other type is just fine, and then the idea that, in fact, in a few months you might decide that, in fact, it went down from 0.3 something to 0.29 and you took it off the list, would cause a lot of trouble.

I think the issue here is, I would not recommend that we put the albacore on the banned list. I think we need to address the fact that it is a very popular fish and we should do the benefit-risk analysis to determine with this important food, where it fits into the scheme.

DR. MILLER: Dr. Dwyer.

DR. DWYER: Well, the good things is there is no chronic wasting disease of tunafish, but I think there is a way to get around this. The advisory for the consumers? Who knows? But I think there is a little algorithm that could be used if we could just come up with what is medium.

You know, are you pregnant, at risk, nursing; if yes, then, the question is do you eat

shark, swordfish, king mackerel or tile fish, using the common names, and if the answer is yes, then, stop it, and if no, do you eat over 6 ounces per week of game or sport-caught fish, and if yes, then, watch not to eat more or check your local advisory.

If no, then, you never eat any of those, then, we get to the issue of trying to make it a positive message for consumers, and the question becomes what the recommendation is for low mercury fish. Doug pointed out there really isn't any if we are talking below 0.1, right?

DR. HEIMBURGER: Or at least no upper limit for low mercury fish.

DR. DWYER: You can eat as much as you want.

DR. HEIMBURGER: With the exception of body weight.

DR. DWYER: Or 12 ounces.

MS. HALLORAN: What did you mean when you said there isn't any--

DR. DWYER: That you could eat a lot of it

without--

DR. HEIMBURGER: Even 12 ounces shouldn't necessarily be considered a limit for low mercury fish in non-pregnant people who don't eat game or sport-caught fish.

MS. HALLORAN: In non-pregnant people.

DR. HEIMBURGER: Right, non-pregnant.

MS. HALLORAN: In pregnant people, it should.

DR. DWYER: There would still be a limit of 12.

MS. HALLORAN: I believe so.

DR. HEIMBURGER: Oh, I am, it is in pregnant people.

DR. DWYER: It is only in pregnant. Then, the only one I can't fill out on this would be, no more than 6 ounces per week of the medium mercury fish, and 12 ounces would be the limit for the--

DR. HEIMBURGER: Why should there be a

12-ounce limit for the low mercury fish in pregnant women?

MS. HALLORAN: Because they all have

mercury.

DR. HEIMBURGER: But if they are low--

MS. HALLORAN: Not that low.

DR. HEIMBURGER: Some are, some are nondetectable.

MS. HALLORAN: No.

DR. MILLER: Well, this isn't getting us very far.

DR. DWYER: Thank you, Dr. Miller. It strikes me that it does. You have got light tuna over in the 12-ounce side, and you have got the albacore in the 6-ounce side, and I think it does get you someplace. And no chronic wasting disease.

DR. MILLER: Well, this issue concerning albacore, that was the question that was being asked, rather than the other fish. It seems to me, having been raised, that question needs to be--we need to come to some recommendation or else we could say we can't make a recommendation because we don't have the data to support a recommendation.

Even if we said that, it seems to me that what we need to do is to recommend that an analysis

of albacore tuna be a priority issue and whatever research activity that FDA and EPA take on.

DR. APOSHIAN: But I thought we had the analysis.

MS. HALLORAN: There is plenty of data.

DR. APOSHIAN: I think there is plenty of data about albacore. The question is what are we going to do about it, are we going to accept that data, are we going to move ahead with it, or are we going to keep talking about it.

DR. LUND: You still get back to the question, though, of what is the net ingestion, not the parts per million in the fish, and if you look at the data on page 13 of their table under Tab 8, Table 2, you look at albacore versus the light canned tuna, the albacore is 3 times higher--

DR. DWYER: We are having trouble. What are you--

DR. LUND: Tab 8 is the paper by Carrington and Bolger. If you look on page 13, there is a table, and that is the one that I think some of our colleagues from FDA have referred to,

to say, look, there is a lot of data out there. The data we showed you in this little special table only happened to compare old data with new data.

So, if you look at line 6, the albacore canned tuna is approximately 3 times higher in concentration, parts per million, measured as mercury--not methylmercury, but measured as mercury, I presume--and its disappearance, its market share, however, is approximately a third.

So, from an impact level, if the market share data reflect what happens across the population, then, the exposure of the population to methylmercury through tuna, either albacore or light tuna, is the same approximately.

DR. APOSHIAN: But not the exposure to the individual.

DR. LUND: That's to the whole population, that's correct.

So, the question comes back again to what is the actual consumption of tuna by pregnant women, women nursing, or women likely to become pregnant. The answer is we don't know. So why

would we suggest banning something because, at this point, the data are incomplete? What happens if you came back with a result, and you went into the NHANES data or you went into some other method of getting those data, and you found out, in fact, that they don't eat a lot of albacore tuna. Now, would you have to come back and change your advisory and say whoops, we made a mistake because now we have more complete data. We now have more complete data, so we are going to change the recommendation again.

DR. APOSHIAN: You are talking about banning.

DR. LUND: I didn't mean banning.

DR. APOSHIAN: Well, whatever you are saying.

DR. LUND: No; I meant to put it into a Don't Consume category.

DR. APOSHIAN: Again, I am not talking about a Don't Consume. What I am talking about is in the prior advisory, no mention was made of tuna as far as a word of caution is concerned, and what

I am suggesting is that some kind of statement be made that albacore should be eaten under certain restrictions or limitations. I am not saying it should be banned. A pregnant woman should be warned that albacore has more mercury in it than light tuna, or lower than whatever the common fish is.

DR. LUND: That is number two in the advisory.

DR. APOSHIAN: Pardon?

DR. LUND: That is directly addressed in the advisory.

DR. APOSHIAN: But it wasn't in the old advisory.

DR. LUND: No; but the new advisory.

DR. MILLER: With regard to the new advisory.

DR. APOSHIAN: So, what I am asking, there is no question--

DR. LUND: But I thought we were discussing whether albacore should be put into that category with swordfish, et cetera. That is what I

thought you were getting at.

DR. APOSHIAN: I gave that up a long time ago, knowing the feelings of this committee. What I am asking for is a word of caution of some kind about albacore itself. I don't have the thing in front of me, so, if it says albacore, fine, that is certainly a major step forward from the last, old advisory.

DR. MILLER: Dr. Scherer, did you have a comment you wanted to make?

DR. SCHERER: My comment is based on the one that we discussed earlier, about the recommendations over time. That clearly is as problem and one that I think all of science faces. It seems to me that any advisory that goes out needs to have some level of small disclaimer saying, based on what we know today.

For me, that is beginning to try to educate the American public that science, by its very nature, changes and we want that to happen rather than coming out with authoritative statements that this is the way it is, and then in

the future, we change it, and, in fact, do confuse people. So I think any advisory needs to begin trying to put a context on it based on what we know today.

DR. APOSHIAN: As a point of clarification, since no one brought it up, saying it's not in the new advisory, under, "To protect your baby, follow these three rules," and I don't see tuna or albacore mentioned anywhere in those three rules.

Later on, if you get to it, frequently asked questions about mercury and fish, under No. 2, what is tuna? It says that tuna steaks generally contain higher levels of mercury than canned tuna. Now, I am not even sure I see the word albacore in there--yes, I guess it is. I am sorry--tuna steaks and canned albacore. But it certainly does not say, to protect your baby, don't eat a can, or 5 cans of albacore a week. I would like to have a word of caution in there.

No one I think believes that they can ban the canning and selling of albacore tuna, but I

thought our role as an advisory committee was to advise the FDA from the knowledge that we may or may not have as far as the public health is concerned, and I would certainly--knowing the pregnant women that I know, young ones, I would certainly like them to know that albacore should be of concern to them, and this doesn't do it at all as far as how to protect your baby.

DR. DICKINSON: I think in response to that comment and many others that have come up, that Johanna had a very good idea just a moment ago, which is what is really hanging us up and what was commented on by many of the speakers today, is the idea that you can eat up to 12 ounces of anything other than these four, and that appears not to be the case.

So, Johanna's idea of having a category of which you would have a limit of 6 ounces of the medium level fish, and then another category of the low mercury fish for which you could go up to 12, I think makes a lot of sense.

I don't see a justification except in

share of the market, and I accept that that is something that needs to be considered, but I don't see a justification for culling albacore out uniquely, out of that middle category.

DR. APOSHIAN: As long as we have three categories, which we don't have at the present time, as long as we have that.

DR. MILLER: Did you have a comment, Jean?

MS. HALLORAN: I agree with what was just said. I agree that three categories would solve the problem, and the statement about tuna, I am particularly concerned about the last sentence, that says, "You can safely include tuna as part of your weekly fish consumption," without specifying that truly, the only kind of tuna that you can include is light tuna.

DR. DICKINSON: Or a lesser amount of albacore.

MS. HALLORAN: Or a smaller amounts of albacore, right.

DR. MILLER: Dr. Aller?

DR. ALLER: No; Thank you. I think the

points have just been made.

DR. MILLER: Dr. Downer?

DR. DOWNER: I am going to talk from the public's perception, John Q. Public, the consumer.

I would suggest that we ought to think about is portion size. The other thing that I think this committee may want to think about is, is there a group that we can classify, a group of fishes that you can eat any amount of, that there is no limit.

That is the group I am interested in, which means the group that can eat as much as I want. That is the group I want us to talk about if we get a chance.

DR. HEIMBURGER: That will address the high-end users.

DR. DOWNER: I am interested in high end and low end, just tell me that you can eat as much of this as you want, that is all I am interested in.

DR. HEIMBURGER: But it would avoid alarming high-end users that they need to drastically reduce their intake of seafood.

DR. DOWNER: I'm sorry; I didn't get you. What did you say?

DR. HEIMBURGER: If you were to give a category within which you could eat as much as you wanted, then, you would avoid alarming people who are already high-end consumers of fish.

DR. DOWNER: That's right, but also for those who are interested in eating fish, this is another way to say, enjoy it, all of these kinds of things. Is the such a group?

DR. HEIMBURGER: But is it possible to create such a category even for--that are low enough to allow that statement.

DR. MILLER: Jean?

MS. HALLORAN: I think the best clue on that is if you look again at this Table 2 that was just referred to, I think you would have to probably stick to like the bottom 3 or 4 items on the list. It would be a very small list. Sardines? Pregnant women like strange things.

DR. HEIMBURGER: Would you want to extend it up as far as salmon and which would include

shrimp. That is the most consumed populationwise.

MS. HALLORAN: We need someone to do the calculations on that for us.

DR. MILLER: Why can't we make a recommendation--let me put it this way--we have come close to the time when we have got to come up with some of these recommendations, and certainly one of the recommendations ought to deal with the format. Much of what we are talking about are format issues, and among them is the development of the three lists indicating the concentration of mercury.

Another thing might be the indication on those list which are the ones--well, let me go back a bit. Another thing is that we have got to recommend that the advisory be more positive in many ways. It is very negative in many areas. We could indicate a group of fish in the lowest concentration area can be consumed. That is the kind of recommendation I think we are going to have to make.

We are also, I think, going to have a

research recommendation. One of the things we ought to be saying in that research recommendation is this is an important enough issue to be a very high priority to the agency. That means that they ought to be spending more money on this issue than they have been spending.

Among these, also in terms of research, we ought to reemphasize the importance of trying to develop a collaboration with the industry, who I am sure have data, and there are ways of developing this data which would not pose difficulty with the companies that are providing that data, like what the agent is with lead in condensed milk. That was a very successful program to reduce lead in condensed milk.  These were data that were collected by NSDA who acted as a broker in making sure that FDA--the data was not used for any regulatory purposes.

There ways of doing this.

But those are the kind of recommendations, and it seems to me that the issue of the albacore thing, it can be at least partially resolved by

having three lists, one of which, the moderate one, is fish to be consumed in restricted consumption of fish.

Dr. Krinsky.

DR. KRINSKY: Thank you. Referring back to this Table 2 in the draft document of December 24th, 2003, the right-hand column has three categories, high, middle, and low. The title of that column is Advisory Group. Was this decided on at the last meeting of this advisory group? What is the basis for this?

DR. MILLER: I have no idea. David, can you clarify it for us?

DR. ACHESON: Yes, I will try to. That was the arbitrary exposure assessment along with the definition of high, medium, and low. The low was modeled around the light tuna, taking that as that, and the low, would be low.

DR. KRINSKY: Then, would it be possible for the recommendation to say no fish consumption in the high group--this is for the pregnant--no fish consumption in the high group, maybe 1 fish

consumption for the serving that is from the middle group, and I don't know how much from the low group. Would that then become unlimited from the low group? Somebody would have to go through the calculations to figure out how much that that group could consume.

I am also not sure whether the arbitrary high grouping is really appropriate, because it seems to me the grouper and orange roughy are really quite high.

DR. MILLER: I think if we recommend that they establish these three groups and the subsequent criteria for them, you would have to look at the entire listing of issues when we develop those pages.

DR. KRINSKY: Well, they would only have to look at the fish for which there is data, though.

DR. MILLER: Yes; that's all they can do.

DR. KRINSKY: I assume that that is what this table is. Were there fish that were not included in this table?

DR. ACHESON: I think essentially, no. Tilefish, frozen tilefish, as we discussed, they are not in there.

DR. MILLER: Dr. Aller?

DR. ALLER: I would also just to make another point. Getting back to the point you raised about collaboration with industry, there are also state laboratories that are out doing NRs. We do mercury analyses on a regular basis and would be very happy to--and, I believe have provided, whether or not they have been used in any of these risk assessments. But we have those data, and share methodologies, et cetera, and I know that has been an ongoing difficulty for FDA over a number of years. I really think we need to get it, not just for the safety, but for so many more--we need to get to the point where FDA can accept other data.

DR. APOSHIAN: Not as a written recommendation, but could we sort of ask the FDA and the EPA people that, when they give us a chart like this, they sort of give us a range of standard

errors, some idea as to what the figure means, because, you know, for a graduate student to give me this kind of data, it just would be absolutely unacceptable without some range or statistical analysis.

DR. CALLERY: I have a suggestion for something that might be added as a recommendation that came out of the discussions of the last couple of days was the use of website information on an advisory, the recommendation that the website for further information be listed on the advisory.

DR. MILLER: Dr. Heimburger?

DR. HEIMBURGER: Just back to the question of whether there are three groups and whether there will be an unlimited group, could we at least recommend that they consider the establishment of a fourth group, which may be just called "very low," from which it might be possible to consider not placing a limit on consumption?

Just end it looking at criteria and deciding where the cutoffs will be between high and medium, medium and low, to consider a third cutoff

for a fourth category of very low.

DR. MILLER: We can do anything. We can make any recommendation we want. It is up to the agencies to implement it.

DR. HEIMBURGER: Right. I am just suggesting--

DR. MILLER: Given the fact that among the most common recommendations that were made in various presentations was to develop a simple approach to the problem, so that anybody could understand it, it seems to me we are going in the opposite direction.

We are making things more complex, not that we don't have to. As long as we couch these recommendations in terms of to have the agency consider these things, because something has to give sooner or later, particularly as we develop and build more into these things.

When I think, for example, we haven't discussed at all, and I would suggest that we do, that we really consider the possibility of having multiple advisories for different population

groups. It simply makes sense to do that.

Having said that, that just makes it more complicated. But there is plenty of experience of doing that. Every dentist's office has a pamphlet in it that tells different groups of people what to do about their problems with their teeth. Well, we are worrying about mercury, not teeth--maybe we are worried about teeth, I don't know.

DR. HEIMBURGER: The amalgams are in there.

DR. MILLER: Johanna?

DR. DWYER: I think that is a good idea, and I certainly don't want to quote Vladimir Lenin in a government advisory group, but I will. Remember he said, "First, socialism in one country," and first, we need an advisory, one advisory, and then we can get to these multiples ones.

It seems to me one thing that might help clarify, back to Dr. Aller's issue, is that the very low fish are fine if we know the frequency of consumption, we have some kind of population-based

data where we know frequency of consumption. Yes; there will always be demand for the lady, like the case in the New England Journal where the man ate 40 eggs a day. Then your bets are all off. The basic point is if most people don't eat very much of very low ones, maybe that is the way.

DR. HEIMBURGER: Salmon and shrimp are there. Shrimp is at the very top, the number-one one, it could be in that group, and salmon is not far behind.

DR. DWYER: If that is what market-share means. Is that what market-share means?

MS. HALLORAN: It is per capita. They are ranked by pounds per capita. Shrimp is number one. Tuna is number two, and salmon is number three.

DR. DWYER: I am sorry, so it's disappearance data, or is it consumption data? Do people eat it or is it what was on the market? It's disappearance data. So, those data are, with all due respect, if it's disappearance data, those data are probably higher amounts of mercury than the actual amount eaten, right?

DR. HEIMBURGER: It's just market-share. Is some of the market-share going to our cats?

DR. DWYER: There is always waste. There is always waste between what is on the market and what you eat.

DR. CARRINGTON: It is supposed to be market-share. I don't know how well they do it. Those aren't my estimates, so I can't tell you exactly how they are done, But they are supposed to be human use, so it should not include pet food.

DR. MILLER: Somebody handed me a list here of fish that would meet the standard of being able to consume as much as you want. They are very low levels.

DR. CARRINGTON: Well, I can volunteer to do another simulation. I can add another simulation to my series. I can do a no high, low only, and then I can do a very low only. I guess the question is where do I pick my cutoff, and I guess I heard salmon. I guess I can take sardines as another one. I can do very low, and very, very low.

DR. HEIMBURGER: A level of 0.03, according to Table 2, though, there is a bit of a gap that the 0.03 might fit into without coming close to any high consumption fish that are just over that level.

DR. MILLER: Well, I don't think we ought to spend too much time or any more time. We are trying to work out what we want the agency to do in the first place, and we don't have the time nor the data to be able to do that, but at least we can make a recommendation to the effect that the agency should consider establishing a very low level for the purposes of determining those fish species that can be consumed in reasonable amounts. But I want to say, as much as you want, that always gets you in trouble.

DR. HEIMBURGER: You get into the obesity issue. The language would have to be chosen carefully.

DR. BUSTA: Earlier, Dr. Halloran indicated that if one made a modification to the current advisory, and included, in addition to the

top 3, we have 4 there and the tilefish could exclude the golden tilefish, which comes in as a low one, probably is a different species, and if one added grouper, orange roughy, and albacore, one would have a top 7 to exclude for this group, and then name the bottom 10--I wouldn't even limit it to 5--I would name the bottom 10 including light tuna as to what you shouldn't do and what you should do.

That seems to me to get us off the dead center. Now, If you want to add this group of reasonable unlimited, and the others 12 ounces, but to me, that seems to give names, and if somebody is eating fish sticks, they have got to just roll the dice.

DR. MILLER: What is in fish sticks?

DR. BUSTA: I don't know what is in fish sticks.

DR. DOWNER: Bread.

DR. APOSHIAN: Whatever is cheap.

DR. DOWNER: Mostly bread.

DR. APOSHIAN: Are we recommending three

separate advisories or are we recommending more than one advisory?

DR. MILLER: I would think we are recommending more than one advisory.

DR. APOSHIAN: We are. Good. Thank you.

DR. MILLER: That is the idea, that there would be more than one advisory designed to be aimed at a specific population.

DR. DWYER: And what are these different advisories for, for whom?

DR. MILLER: Different populations.

DR. DWYER: What different populations, women who are pregnant?

DR. MILLER: I am sure a male, for example, could certainly eat more, and should eat more, fish, and we don't have to worry as much for them.

DR. DWYER: I don't see why you can't have an algorithm that deals with all of them, and then develop the communications tools, which I certainly am not competent to do, and I might add that there are many others who are not competent to do, and

leave it at that. I mean our expertise is not communications.

DR. MILLER: What we are looking for is a simple way of dealing with this, at least I think that is what we are looking for.

DR. DWYER: Right.

DR. MILLER: And if you try to put everything into the same mode, you end up with a tree that doesn't necessarily prune very well.

DR. DWYER: I don't think you do. I think you end up with an algorithm like that sheet that I proposed.

DR. MILLER: I was going to say that this is one more approach to the problem. This isn't the only approach to the problem. To ask people to sit down and fill out a form to decide how much fish they are going to eat is a bit much.

What I would say is, what I would like to do is include this in the record as an approach that the agency might choose to select. I have my own problems with algorithms like this.

Dr. Russell.

DR. RUSSELL: I actually agree with Dr. Dwyer. I think that to have one advisory is what we need, and then to have different communication tools to be targeted to parents of young children, to professionals, and to other groups, I don't know. I don't know whether Asians would need a different advisory or not--a different educational tool or not, but I do believe that one advisory is really what we want to lean toward, and that would be the simplest, most clear message to the population in general.

DR. MILLER: David, did you want to make a comment?

DR. ACHESON: Yes. Thank you, Dr. Miller. We were just having a brief discussion of some of the complexities that would be involved in developing multiple advisories, and also the complexities involved in trying to define high, medium, and low.

Certainly, it is obviously the committee's prerogative to say that is our problem to deal with, but I fear that if we were to set a divide,

criteria that was specific for high, medium, and low, particularly medium/low, obviously, there is a big issue whether a fish jumps from medium to low, and if there is going to be a defined point, and we are going to continue to test. I have already said that, and you are certainly recommending that we continue to do that.

I worry that we would have another tilefish example where we thought some something was high, and whoops, you know, goldface tilefish or golden tilefish are low, maybe we need more data.

I am just concerned that we are going to get, as you pointed out, Dr. Miller, increasing complexity and increasing concern about that, and I really just wanted to make that point, that the science may be some good ideas, but it is certainly, in terms of trying to translate this into a simple message, going to be difficult.

DR. MILLER: Without debating the issue, it seems to me that what should be done is to try it, in other words, as far as the different groups

are concerned, the data would have to be worked out, and the endpoint would be what would be the exposure, based on your exposure information.

I think as far as the multiple advisories are concerned, again, the question is how different would these advisories be.

DR. ACHESON: Well, we would have to look into that. I mean again it would be nice to have a recommendation as to--if we are doing multiple advisories, do we break out young children from pregnant women and women who may become pregnant? That wasn't clear to me from the discussion.

Obviously, adult males are a different category, sure. But if we are going to go down the road of multiple advisories, just exactly what would the recommendation be of what they should be would be helpful, and what would come first, what is the most important one to tackle first and get that out.

DR. MILLER: I think an answer, to start on the second. My own recommendation would be pregnant women or women who might become pregnant.

Dr. Scherer.

DR. SCHERER: I had a couple of points. It seems to me that the issue is not multiple advisories as much as it is putting it in a format that is better understood by the multiple audiences, so that the idea is to identify those target audiences that are at the highest risk, take this common advisory that everyone has agreed upon, and make sure it is in a format so that they understand that, that content.

So, it might be a general advisory that is available to the public but targeted to make sure that pregnant women understand the importance of the parts for them. So, it is more of a design issue as opposed to changing the content of it.

I had one other thought in terms of a recommendation related to this. It seems to me that once the tinkering with the content of the advisory and getting it to a point where it seems to be appropriate, I think the next step really needs to be, in terms of a recommendation from this committee, that it then be taken to audiences again

to understand what is it that they remembering from it and what is it that they translate into the behavior, so they have a better understanding of those audiences before it really is distributed widely.

DR. MILLER: One of the thoughts of our charge was to agree, or disagree, for the development of an outreach and educational program for these things. Do I take it, given the nature of our discussion here that the committee agrees with that, that the agencies ought to develop those programs?

DR. HEIMBURGER: Yes.

DR. DWYER: I have to say I think those are wonderful ideas, but first, we have to find out what is in the fish, and how many fish that people are eating.

DR. MILLER: Well, that is the other question. The other question is shall we tell the agency to delay in releasing an advisory at all until all this data is together or do we suggest that they go ahead with the changes that have been

suggested, and that further testing needs to be done, but go ahead with the idea that they are going to put it out and have to change it later on when new data comes on.

That is the balance that we are running into here. This could be taking several years.

DR. HEIMBURGER: Could we come up with a very short list of things that we think ought to be considered for very, almost, you know, for accelerated implementation, but just very minor things, and rest should wait until more data are available?

DR. LUND: I actually thought that is where we were going. I thought that EPA and FDA were charged to look at a specific advisory to a specific subgroup of our population; pregnant women, women nursing, and women that may be about to become pregnant, or wanting to become pregnant or something, but in any event, that these special subgroups and small children, and babies, and they were to look at those advisories from those two regulatory agencies and come to a common

understanding of what the advice should be.

I haven't heard anything that suggests that they should not continue to do that. What I have heard around the table that there are some things in here that we think need to really be examined, and that is, the issue of meal size or the portion size, the issue of naming specific species and making sure people understand what they are, making sure it is absolutely clear that there is a strong, positive message in here, it is not just a negative message first, et cetera.

So, I think our recommendation is to proceed in going through this process based on what you have heard here, coming out of the comments of the various members of the Advisory Committee, and continue to work, however, on the database both with regard to populations and what they eat, what the distribution of the consumption is of fish and fish products, and with regard to the database for the levels of methylmercury in fish.

That is where I thought we were coming out at.

DR. ACHOLONU: I thought that somebody suggested that we prepare this and put in on the website as a draft and leave it there with the understanding that it may be undergoing some changes as permission becomes available. I thought a suggestion was made that we put this on the website.

DR. MILLER: The suggestion was made to put it on the website, but it doesn't indicate necessarily how long the agency will have to wait. I mean what is concerning me is that we can continue to increase the amount of data that we think we need in order to deal with this.

The question is at what point do we say that can continue, but we have got to get on with the process of coming out with an advisory of some kind, and you just keep making the risks bigger and bigger and bigger.

DR. ACHOLONU: If we indicate that, as of now, there is going to be information available, because things change, and the list that we have, the high, the medium, and the low, there is a

possibility that they can change with time.

DR. MILLER: I agree.

DR. ACHOLONU: So, we may not come up with something that is finite at this time, but there should be something that people can use as guideline at the present moment, just indicate that it is not final and that as new information becomes available, it will be updated.

DR. MILLER: Well, several members of the group are going to be leaving in the next 15 to 30 minutes, so we need to come to a conclusion. I can one make recommendation to facilitate this.

When the transcript is available, we can go through the transcripts and try to make a list of the recommendations that we made, and we will share it with the committee for their comments. Let's try and focus on the most important issues rather than every one of them.

DR. WASLIEN: If we did it as individuals and voted on which ones we thought were first priority, second priority, you know, when we get it back. Then you can get a democratic process.

That is not necessarily the correct process, but that would help us in sort of prioritizing afterwards.

DR. MILLER: We can indicate on the list where we think this ought to be in terms of priorities, first, second, or third.

DR. WASLIEN: Yes.

DR. MILLER: Dr. Durst?

DR. DURST: I agree with Dr. Lund that the primary issue for this committee was to determine what could come out as a unified document from the two agencies, and I think we have a good basis for this in the advisory that is here. Once the comments of the committee are incorporated into this, and it is put on the web for further discussion, I think we are off to a good start for this document.

I also agree with Dr. Lund that this should be aimed at the individuals that were in the original advisory, that we focus in on this particular group.

DR. MILLER: That is true.

Dr. Krinsky?

DR. KRINSKY: In the first place, I don't see how you can put it on the web without the EPA approving of what has happened here, because this is a joint advisory, not a single-agency advisory, and I don't know how long that process would take and how much input they would want in changing whatever has been changed here.

So, this, to me, is a very complicated issue with the two agencies putting out a simultaneous advisory, but I want to go back to a suggestion that the Chair raised, and that was to have more than one advisory.

It seems to me when an issue becomes sufficiently complicated in a committee, somebody always says, well, let's divide the question so we can address each portion as well as we can. I think the issue of the children is given very short shrift in the present advisory.

The statement is, "Follow these same rules when feeding fish and shellfish to your young child, but the serving sizes should be smaller."

Well, you know, the young child can vary from 20 pounds to 80 pounds, and we don't have any clarity in terms of what the serving size is, certainly not what the serving size is for children.

I think if that were presented as a single free-standing advisory, one could, in fact, give some very useful information that would be immediately available rather than having the consumer having to go to another source to look up that particular information.

DR. MILLER: Good point.

The bus to take the people back to Reagan National is waiting and he wants to know how long.

DR. DWYER: Could I ask a question, a procedural question. Isn't all of this public information?

DR. MILLER: Oh, yes.

DR. DWYER: So, it is already all over the Washington Post and Chicago Tribune, and so forth.

DR. MILLER: There is nothing secret about it.

DR. DWYER: What is the problem about

posting it to the web and than making better things as time goes on?

DR. MILLER: No problem. It's a question of time. It's a question of how long. Before you post things, you have got to get permission through the hierarchy.

DR. DWYER: Well, it can't take more than two years, which is what it has taken.

DR. MILLER: But, Johanna, that's the issue right there in a nutshell. It took two years.

DR. ALLER: I am going to also try to bring us back perhaps--again, I keep going back to the fact that we are looking at targeting at some, what, 8 percent of the population, and that we were provided a draft advisory and asked to comment on it, and at the risk of something, it seems to me that where I would like to see us focus on that advisory is we heard that, in framing that message, that several behavioral do's and don'ts are appropriate; don't eat this fish, do not consume this.

I think in my very simplistic view of this, it seems that my advice back to the agencies would be tinker a big with your three rules. I am not sure you have quite got those rules correct. Do eat this. There may be a group from which you can have one meal, and this gets to the serving size and the portion, and all of that, but here is something for which you need to be very, very limited, and here are the fish, here is a whole list in this case of the do eats.

These are the ones, again getting back to that low group. I don't know if we are going to come up with that very low group or not, and I wouldn't worry about it at this particular point in time, because I do think it is important to get this message out.

I do think we also need to say to the agencies, you made a stab at tuna, but we don't think you quite got that right, so let's put light tuna into that lower group. I am not quite sure I have heard enough to be convinced where albacore goes, whether it goes in the do not or into that

once-a-week with whatever portion size.

I think the other place that we thought the agency didn't quite get it right had to do with portion size, not only for the adult, but for children. I think that there was a suggestion, and I think it has a great deal of validity, to take a couple of weights of kids and say this is what this translates into. I think that is very useful advice that people can follow.

Those were the, like, basic messages that I heard. The other thing I heard was in the delivery of these messages, there may be different ways to deliver that message, and let's get some more work on that. But my own sense is, if we structure our conversation next to where do we think that albacore should be, I would feel more comfortable going back, and I think we have come up with a pretty good set of, this is your priority, this is what we feel is the priority for the agencies, and we can give you these wonderful long laundry lists that we have heard here of lots of other things you can do spend your money and direct

resources into more information, which I believe we do still need.

DR. MILLER: That is very good. I wish I would have thought of it myself.

Suppose we take that as a start for putting together the recommendations that we talked about, and we will get it out of the transcripts, so I won't make you write it down.

DR. ALLER: Thank you.

Because of the hour, unless there is something that is vital, really vital, I am going to thank you all very much for dealing with an extremely complex situation, thank all the other speakers and the staff people from EPA and FDA for making excellent presentations.

I declare this meeting adjourned.

[Whereupon, at 3:55 p.m., the meeting

concluded.]