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.