> 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]{.underline}
>
> **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]{.underline}
>
> **Public Comments (Continued)**
>
> Susan Boehm, Ph.D. 125
>
> New York Academy of Science
>
> Jane Houlihan 132
>
> Environmental Working Group
>
> Rona Applebaum 157
>
> National Food Processors Association
>
> Diana Zuckerman, M.D. 167
>
> National Center for Policy Research
>
> for Women and Families
>
> Dr. Joshua Cohen, 175
>
> Harvard Center for Risk Analysis
>
> John Stiker 188
>
> Bumble Bee Tuna
>
> Lillian Beard, M.D. 203
>
> George Washington University;
>
> Howard University
>
> **FAC Discussion and Comments** 209
>
> P R O C E E D I N G S
>
> **Call to Order**
>
> DR. RUSSELL: Since we are starting late, we thought we should go
> ahead. We have a talk today on focus group testing by Marjorie
> Davidson. Marjorie, please go ahead.
>
> **Focus Group Testing**
>
> DR. DAVIDSON: Thank you. Good morning. Carrying forth our discussion
> on the process that we went through in developing our Methylmercury
> Advisory, once we had our initial draft, we took it to focus group
> testing.
>
> In the draft version that we took to our focus groups, I want to
> remind you that the message
>
> was for pregnant women or women who may become pregnant, nursing
> mothers, and young children was included in the whole advisory this
> time, as well.
>
> We have eight focus groups. They were geographically located
> throughout the country and we picked high fish-eating areas -
> Calverton, Maryland, New Orleans, Louisiana, Seattle, Washington, and
> Minneapolis, Minnesota.
>
> We held mixed gender groups, as well as low education and high
> education groups. There were groups of pregnant women, women of
> childbearing age, and parents of young children. We held them in
> November 2001 and as Denise mentioned yesterday, it was an iterative
> process. We took the initial draft we had and modified it as we went
> along through the focus groups.
>
> I would like to add that virtually everyone but probably one or two
> people was already eating within the limits of the consumer advisory,
> eating fish within those limits.
>
> The goal of the focus groups was to examine risk communication
> formats, to look at various approaches we could use at explaining the
> risk of methylmercury in fish and also we wanted to see how these
> consumers would respond to the advice.
>
> We were particularly paying attention to the three areas that were
> recommended by the Food Advisory Committee, the enhanced attention to
> young children that was not included in the advisory, the
>
> merging of commercial and noncommercial fish, as well as a discussion
> of tuna.
>
> We were continuing, as we have constantly done as we have been working
> on this advisory, we wanted to be sure that we kept a balance between
> letting consumers know about the risks of methylmercury in fish, and
> not jeopardizing their eating fish to get the nutritional benefits
> from it.
>
> Our findings were that most people want a very simple message. This is
> not unusual for fish advisories, it is pretty much the case for all of
> our health education messages. People wanted to know what the arm was
> and they wanted to know how to avoid the harm.
>
> As always, there were people who were greater information seekers, who
> wanted to know more information than the norm, and some of the things
> they wanted to know about were what exactly would methylmercury do to
> affect the health of the child, data about particular species of fish.
> They wanted to be able to look up this particular fish
>
> they eat, and they also wanted to know how methylmercury would affect
> others, other members of their families, other members of their
> community.
>
> Also, our results regarding tuna, we found that the difference between
> tuna fillets and tuna steaks, the different methylmercury contents
> versus white canned tuna was not known to most people. To most people,
> that was new information. As a results, some participants said that
> they would avoid tuna steaks and albacore tuna and move more to the
> lighter tuna.
>
> The results of tuna in general, how they felt about their actions to
> tuna as a fish, I will talk about more in the general reaction to fish
> advisories.
>
> What about recreational fish? Again, this is the first time we had
> merged the recreational fish advice with the commercial fish advice.
> We learned that avoiding commercial fish when you were eating
> recreational fish in the event that there was no fish advisory in a
> particular state was new information to many participants.
>
> We also learned that people, for the most part, think of their
> fish-eating practices as holistic. They don\'t think I ate three
> commercial fish this week and two sport-caught fish.
>
> I personally found it interesting that quite a number of people in
> these focus groups weren\'t aware that they needed to look at state
> advisories on the safety of their fish. That was surprising to me.
>
> What did participants say they would do? Almost all participants
> reported that they do not eat fish. This was not particularly
> difficult to do since most of them did not eat that species of fish
> anyway, but some participants said that they would eat less fish and
> some participants said they would serve less fish to their children,
> and this was the same as the description of what they would do with
> tuna.
>
> Another finding that we found, there was a spillover effect as
> actually was the case in our first set of focus groups, as well, that
> once they learned there was a risk of methylmercury in fish,
>
> they thought it was important to tell others about it, because if it
> wasn\'t good for a pregnant woman or a young child, it probably
> wasn\'t good for them either.
>
> So, in conclusion, I would like to say that it is our belief that
> women will follow, they won\'t exceed the safe fish advisory, however,
> we will be challenged to ensure that they continue to eat fish and
> gain the nutrients from it.
>
> DR. RUSSELL: Before you start the questions, I just want to remind you
> to turn off any cell phones that you have or turn them to vibrate at
> any rate.
>
> Questions, please.
>
> **Questions of Clarification**
>
> DR. DURST: I was just curious, how were the participants in these
> focus groups selected? I mean as far as the breadth of their
> education, and so on.
>
> DR. DAVIDSON: We had separate groups, which were high school graduates
> or less than high school, and then we had groups that had some
>
> college or had finished college, and then we had some that were a
> mixture of the two.
>
> DR. APOSHIAN: I am very ignorant of focus groups and I wondered, is
> there any evidence that validates the use of focus groups for this
> sort of thing?
>
> DR. DAVIDSON: Well, they are used traditionally to find more patterns
> of response from different kinds and groups of people. It is a
> research tool that is used frequently in social science research.
>
> DR. APOSHIAN: If I were doing a study and published something, one of
> the first things that a referee would ask is how do you validate the
> analytical techniques you are using, and I am curious and wonder
> whether there is some reference that is available to us to validate
> the use of focus groups to obtain this kind of information.
>
> DR. LUND: I am not a sensory scientist, but the use of focus groups in
> a wide variety of industries, particularly the food industry, is well
> documented and I think there would be books and
>
> other materials that would have been peer reviewed, in fact, attesting
> to the validity of using focus groups.
>
> DR. RUSSELL: Dr. Scherer.
>
> DR. SCHERER: The use of focus groups, keep in mind, really, the
> objective is to get them to help you with the message in this case. I
> don\'t think there was any attempt to really try to use it to get a
> more demographic profile about how people react to the message. It was
> for improving the message over time, getting people to interact.
>
> But I guess my question would relate to the extent to which different
> demographic groups, particularly, for example, Asian groups, might
> react to the message in a very different way.
>
> It would seem to me that one of the issues might be that certain
> groups\--again, I refer to the Asian group\--may eat a narrower range
> of fish, they may have different names for the fish, there may be
> other kinds of issues that are relevant to particular demographic
> profiles.
>
> I was wondering whether there was any
>
> thought given to examining other groups, for example, a focus group
> specifically with
>
> Asian-Americans or some other.
>
> DR. DAVIDSON: We haven\'t formally through FDA, but we are informally
> working with folks in California right now, with the State of
> California, as well as our local public affairs specialists in the
> field there, and trying to see how this advisory could be translated
> into that community. I totally agree with you.
>
> DR. DURST: It was just to follow up again, but I think your comments
> clarified, because I was a little concerned that with the focus
> groups, that if they were not representative of the general
> population, you were going to get a biased result.
>
> That was my original question about how these people were selected. If
> they were volunteers, again, you are going to get people who are more
> proactive in things and would not be representative.
>
> DR. ACHOLONU: As a follow-up to that, I
>
> was wondering about the focus group. Did you include the
> African-Americans because it is believed that this group eat more fish
> than other groups?
>
> DR. DAVIDSON: African-Americans were part of these focus groups. There
> wasn\'t a special African-American focus group.
>
> DR. SCHERER: I had one other question and this relates more to perhaps
> a little bit broader issue than just the focus groups, but it seems to
> me that going through a process in which we evaluate the message and
> have some understanding of how people are reacting to that message is
> really only the first step, because it seems to me that the real issue
> is the behavioral step.
>
> That is a much more difficult one to try to analyze and understand,
> yet, in a message as complex as this particular message, it seems to
> me that that is really what we are trying to do.
>
> We really would not want people to, number one, stop eating fish as a
> result of seeing or remembering one little bit of the message, and at
>
> the same time, we don\'t want them to say yes, I understand the
> message, but I am going to ignore it.
>
> So, it seems to me that that is the real component of trying to
> understand. I realize that that is a very difficult thing to begin
> doing, but I am just wondering whether there is any thought about
> giving some effort to try to understand at least behavioral intent, if
> not actual long-term behavioral measures.
>
> DR. DAVIDSON: How it is planned further than what I reported on at
> this moment, but we are also not finished with our efforts in this
> regard, as well. I appreciate very much what you are saying.
>
> MS. HALLORAN: I think that is a very interesting point. You obviously
> reported some statements of intent about behavior. I don\'t know if
> you have a way to follow up with the members in six months and a year
> to see if they report actually changing buying habits.
>
> DR. DAVIDSON: I would not surmise that we
>
> would be following up with these particular members, but we do have
> evaluation techniques that we will undertake at FDA, more of a survey
> nature actually, to find out what people are actually doing regarding
> the fish advisory.
>
> DR. DOWNER: I have conducted several focus groups for different things
> myself in terms of health. I am just curious, can you tell me exactly
> how the focus groups were done in terms of exactly what you did as you
> got the groups together?
>
> I have found that when you select a group and you have somebody who is
> very vocal, that they can easily sway the discussion and the intent is
> changed. So, what I usually do is I have something in writing for
> people to fill out the form and then go into the discussion.
>
> Can you tell me if you did something like that or it was completely
> discussion? The information you gathered is very important and was
> very worthwhile actually, but I am just curious to see if there are
> one or two persons in several
>
> groups that had the majority input and you didn\'t get some more
> substantive supplemental information from other members of your focus
> group.
>
> DR. DAVIDSON: I certainly agree and appreciate the comment that you
> are stating. I actually did not do the focus groups, we hired a
> professional company to do them, who are skilled in turning the
> discussion away from folks that tend to dominate.
>
> That was also one of the reasons why we divided education up for the
> most part, so that the higher educated people didn\'t dominate the
> group.
>
> DR. DWYER: Dr. Russell, could you just tell us or could someone tell
> us - we have got a bunch of press releases here, one of which seems to
> be from this year, one of which seems to be from last year, and one of
> which seems to be from the year before.
>
> I understand why the press release from this year is here, but why are
> the others here, just as background, or what?
>
> MS. REED: Can you just tell us what you
>
> are referring to, Dr. Dwyer? These were all distributed this morning,
> I am presuming by public commenters, that we will be hearing from this
> morning. It\'s just background information.
>
> DR. DWYER: Oh, I see. Fair enough.
>
> DR. MILLER: I want to, first of all, apologize for being late. It just
> took two hours to come in from Bethesda, normally, a 25-minute drive.
> I am not sure whether it was this meeting or it was the weather.
>
> In any case, we now have come to the essence of the discussion, the
> presentation of the joint advisory.
>
> David, you are going to start out?
>
> **Joint Advisory**
>
> **CFSAN**
>
> DR. ACHESON: Yes, Dr. Miller. This again is going to be a joint effort
> between myself and Jim Pendergast from EPA, and I am just going to
> give a little introduction and overview of some of the major changes
> in the new advisory and then hand over to Jim to continue.
>
> These first few slides just summarize some of the major points in
> response to the recommendations and how we have tried to incorporate
> those into the revised advisory.
>
> The first point is that this new advisory does cover both commercial
> and recreational fish and shellfish as part of the joint effort
> between FDA and EPA.
>
> Secondly, this revised advisory is directed towards pregnant women,
> women who may become pregnant, nursing mothers, and young children,
> and that, as I explained yesterday, is a slight departure from what
> FDA did in 2001 in that there is more emphasis on young children than
> we had in the past.
>
> The third major issue in response to the recommendations, the Do Not
> Eat list, that is unchanged, there was no recommendation to change
> that, and again as I pointed out yesterday, we do not have new data,
> new science that would suggest that we should change that, but
> clearly, we will keep an open mind, and as we pursue testing on, for
>
> example, tilefish, we will revise the advisory accordingly.
>
> The fourth point in relation to the amount, again, the amount, the 12
> ounces has not changed. That was the same as 2001. What we have done
> is we have tried to clarify that message in response to the request or
> the recommendation from the committee to be more specific about
> variety.
>
> As we explained yesterday, we have found a way to do that through new
> language, and as you have just heard, that has been tested in the fact
> that we are now saying two to three servings. So, that is how we
> responded to that.
>
> The fifth point in relation to locally caught fish. The advice on the
> amount of the locally caught fish again has not changed. It is the
> same as in the 2001 EPA advice. But what we have tried to do is to
> clarify this issue of don\'t consume locally caught fish and
> commercially caught fish in the same week, so that there is a better
> understanding of that issue.
>
> Finally, again, this was really in
>
> response to focus group testing and what worked the best was that we
> have developed a series of questions and answers on specific points,
> and that is a departure from the 2001 format, in fact, it is quite a
> significant departure.
>
> As you will see on the draft, we now have a series of questions and
> answers that cover a variety of issues. We certainly don\'t intend
> that this is going to be a compendium of methylmercury in fish.
>
> We anticipate that people may have other questions, so we provide a
> hot line number, and we provide a web site which we would augment with
> data and information and keep updated again with specific amounts of
> methylmercury in the different fish species as we develop it.
>
> The one point again I want to emphasize in relation to the Q and A is
> what we said about tuna, which I did mention yesterday, and the bottom
> part of this slide just is the quotation of our answer to that
> question.
>
> I am not going to re-read that, but I just
>
> want to point out that we are now saying something specific about
> tuna. We decided that a factual statement about tuna was the most
> appropriate way to go and added the statement at the end that you can
> safely include tuna as part of your weekly fish consumption diet.
>
> Now, that statement, linked with the second rule in the advisory,
> would indicate that if you mix up the fish, as we are recommending,
> and you want to consume tuna, then, you would essentially be consuming
> four to six ounces of tuna a week, because you would only eat one type
> of fish per week. If you have eaten one type of fish, then, you need
> to do some other kind of fish, some other type of fish if you are
> going to have a second fish meal.
>
> That really summarizes the main issues and I really just wanted to
> pick those out and focus on them just briefly before handing over to
> Jim Pendergast, who is going to take you through kind of the full
> advisory from beginning to end, so maybe you can defer questions on
> this part until we
>
> are completed.
>
> **Joint Advisory**
>
> **EPA**
>
> MR. PENDERGAST: Good morning. I guess this is the part that folks have
> been waiting for is what is the draft advisory. As Marjorie had said,
> during the focus groups, we had tried different types of the advisory,
> we learned as we went along. If the message wasn\'t getting across, we
> tinkered with it and tried to make it more clear and tested it at the
> next focus group.
>
> So, what you are going to see on here is what has resulted from the
> process of going through the four focus groups.
>
> The draft advisory has three parts. There is a risk message, what is
> the risk, there is the consumer advice, and as David said, there are
> some Q\'s and A\'s that we put at the end to help provide some more
> information. A lot of the reasons for these Q\'s and A\'s came about
> from some of the questions that we heard at the focus groups.
>
> The first part of the risk message is who is at risk. It is in the
> title of the document
>
> itself, women who are pregnant, who may become pregnant, nursing
> mothers, and young children.
>
> We also explained why they are at risk and we talk about the benefits,
> the positive benefits of eating fish. We want to make sure that that
> point comes across, and that is something you also heard from the
> focus groups, why should we eat fish, and also point out that what are
> the potential problems of eating fish that are high in methylmercury.
> That is part of the risk message.
>
> Precisely what we say is that, \"Fish and shellfish can be an
> important part of a balanced diet. It is a good source of high quality
> protein and other nutrients and is low in fat. The FDA and EPA are
> advising pregnant women and nursing mothers to eat the types and
> amounts of fish and shellfish that are safe to prevent harm to the
> development of their baby or young child.\"
>
> We also provide a statement that, \"If you follow the advice given by
> FDA and EPA, you will gain the positive benefits of eating fish but
> avoid any developmental problems from mercury in fish.\"
>
> Again, this something that we heard from the focus group is that why
> should we eat fish and what is wrong about eating fish that are high
> in mercury.
>
> The second part of the advisory is actually the advice to the
> consumers. We have tried to break it down into three parts. We tried
> to get it to a message that was clear, so the results in the focus
> groups, that the feedback we got from them is that they understood
> what the message was and they would be able to tell us how this might
> affect their behavior.
>
> The first part is similar to what we had in the 2001 advisory. There
> are four types of fish based upon the information we have that we
> recommend that the target of the advisory, pregnant women, women who
> may become pregnant, nursing mothers, young children, don\'t eat the
> four fish we have here: shark, swordfish, tilefish, and king mackerel.
>
> The second rule is the part that David talked about just briefly
> before, is that we recognize that levels of mercury in fish can vary,
>
> and we recommend that you can safely eat up to 12 ounces, which is two
> or three meals a week, of other purchased fish and shellfish a week,
> but mix up the types of fish, and do not eat the same type of fish and
> shellfish more than once a week.
>
> What we mean by this is that, for example, if a pregnant woman was
> going to have a meal of tuna, which is 4 to 6 ounces, that that would
> be the sole meal of tuna that week, and that she would balance that
> with eating a different type of fish that week.
>
> The same thing is that if a woman was eating, let\'s say, grouper,
> that would be one meal of grouper a week and balance it with different
> types of fish.
>
> As we have talked before, is that in the implementation that we will
> be having up on the FDA website and links from the EPA website to what
> we know about levels of mercury in fish, so that the consumer who
> wants to do research for himself or herself can go and look and find
> what types of fish that perhaps are lower in mercury and choose how he
>
> or she is going to construct their diet. That is a piece of
> information to be able to help.
>
> The third rule is the rule that brings in the role of local
> advisories. What we are saying is for people to check their local
> advisories about the safety of fish caught by family and friends in
> your local rivers and streams. If no advice is available, you can
> safely eat up to 6 ounces, one meal per week of fish that you catch
> from local waters, but don\'t consume any other fish during that week.
>
> We needed to do this because across the United States where people are
> catching fish, the amount of mercury in fish varies, and vary for
> something as low as 0.05 parts per million as an average for species
> up to almost 0.9. This varies based upon the type of species, the
> location, the age of the fish.
>
> States have already issued advisories based upon what they know from
> data that they have collected. We want to make sure that consumers
> know about this information. This is the reason for
>
> this third rule, and it is part of the implementation links that go
> from here to a website that we have in EPA that links to advisories
> that states have issued around the country.
>
> We also recognize that states can\'t be everywhere and test fish
> everywhere. What to do about those waters where a state has either not
> issued advisory or doesn\'t have any information to be able to say
> that folks can safely eat fish at 8 meals a month, 12 meals a month,
> or something like that, that is the reason for the 6 ounces, it
> catches where we don\'t have information, and it is based upon what we
> know from where we do have information and taking a look at
> essentially a median of the various species, so that folks can have
> some level of protection or some level of knowledge in terms of what
> they can safely eat.
>
> Recognizing that concentrations can be high in some of these fish,
> that is why we came up with the recommendation that if you eat that
> one meal a week of recreationally caught fish, that\'s it, don\'t add
> anything else to it.
>
> In recognition of small children, we also recommend that the people
> following the advice follow the same advice with children, but
> recognize that children have smaller body mass and they tend to eat a
> little bit less, that they should eat less fish or less than the 12
> ounces.
>
> Now, the Q\'s and A\'s. Again, this comes from the balance of how much
> information you put upfront in an advisory that gets the message
> across without overwhelming people so that they lose the message.
>
> It also comes from the part of being able to recognize or to respond
> to some of the questions that we got or that we heard from the focus
> groups, the questions that they asked the moderator, places where they
> said they needed more information.
>
> One of the most frequently asked questions that we heard was, \"I
> thought fish was good for me. Why are you telling me that I should
> constrain the amount of fish that we eat?\"
>
> We tried to answer that. It is, that is, fish and other seafood have
> long been considered to
>
> be good sources of protein with the added advantage of being low in
> saturated fat and high in healthy omega-3 fatty acids. However,
> scientists have learned that shark, swordfish, king mackerel, and
> tilefish contain levels of mercury in them that may harm your unborn
> child.
>
> This is why FDA and EPA are advising you to avoid these fish. By
> eating other types of fish in moderation, you will get the health
> benefits of fish, trying to directly respond to the concerns and the
> questions that we heard at the focus groups.
>
> The second question is about tuna. David went over this question
> before, but this was also a question that came up as folks would ask
> that question, what about tuna, and they did not understand, as
> Marjorie said, the differences between the mercury levels in albacore
> tuna and tuna steaks as compared to the chunk light tuna. We wanted to
> be able to provide that information to them.
>
> The third question is, is methylmercury in
>
> all fish, and this is recognition of the idea that there is a natural
> reaction of fearing that there is something bad in your food, that
> people may run away from that food completely.
>
> We know that there is methylmercury in all fish, and we needed to be
> able to provide the appropriate information for people to understand
> that it is the level of mercury that is important in the amount of
> fish they eat, not the fact that there is some measured mercury in a
> fish.
>
> So, we answer that by saying nearly all fish contain traces of
> methylmercury. However, larger fish that have lived longer have the
> highest levels of methylmercury, so they have had more time to
> accumulate it.
>
> One of the questions that Marjorie pointed out is people wanted to
> know why is there mercury in the larger fish.
>
> Other types of fish are safe to eat, if you want more information,
> where to go for the information, trying to respond again to the focus
> groups.
>
> Another question that came up in a couple of focus groups is, \"But I
> am not pregnant, so why should I care about this?\" Some of this also
> came to a point that was made in a couple of the groups, that not
> every woman intends to get pregnant, and therefore, women need to
> understand the message if they could become pregnant.
>
> This is a very important point that we needed to clarify, because at
> one group we actually heard a woman, who to me appeared to be in her
> 30s, said, \"I am not going to have any more children, so can I just
> eat all the fish I want?\"
>
> This is to try to answer that question, that mercury can accumulate in
> your bloodstream over time, it is removed from your body naturally,
> but it may take over a year for the levels to drop significantly,
> therefore, it may be present in a woman even before she becomes
> pregnant. That is why it is important, of women who are of the age
> that they could become pregnant, and we also suggest that if they have
> questions about a concern that they may have consumed large amounts of
> mercury, to
>
> talk to their physician.
>
> Another question that came up is about the local information, why be
> concerned about the local information about advisories. We tried to
> address that, as well, to explain that some kinds of fish and
> shellfish may have higher or much lower than average levels of
> mercury. Like I said, from the information we have based upon species,
> it can range from 0.05 parts per million to almost 0.9 parts per
> million. That is an order of magnitude variation.
>
> This is the reason why people, this is how we try to answer why folks
> needed to understand about locally caught fish.
>
> Another question that we heard is how do I get this information, how
> do I learn about local advisories, and we try to answer that question
> by pointing out that states have fishing regulations booklets, some of
> them do. You can contact local health departments, and we also provide
> links to state and tribal contact information.
>
> One of the last questions on here is what
>
> is mercury. Recognizing that mercury is an element and it has been
> around, that it occurs naturally in the environment and also can be
> released into the environment, from our view, primarily from air
> emissions through industrial pollution.
>
> It falls from the air, accumulates in streams and oceans, turned into
> methylmercury in water. We try to provide that information. We did
> hear folks who asked questions, well, how does mercury get into the
> fish anyhow, and this provides some of the basic information, so that
> folks can understand.
>
> At the very end of the advisory, of course, we provide links to where
> to go for more information, both with FDA and EPA with websites, and
> in the case of FDA, with their hot line.
>
> We also provide links to the state and tribal public health offices
> that issue fish advisories, so people can very quickly find where the
> local advice is.
>
> Lastly, where are we going from here? The advisory we have right now
> is draft. We are
>
> seeking input today. We have some other steps along the way. As
> Marjorie said, we did talk to focus groups.
>
> Back in July, we had a stakeholder meeting where we talked about some
> ideas, but in the future, we have a National Forum on Contaminants in
> Fish that EPA co-sponsors with ATSDR. We will be discussing with state
> and tribal public health officials the draft advisory, get some of
> their concerns and ideas on that and what we need to do.
>
> We are targeting to be able to come up with a final advisory by
> February, after receiving the input that we can possibly gain on here,
> again with the overall idea of having a message that is able to
> capture the sense that it is important to eat fish, but it is
> important not to eat too much of the wrong fish, and to try to get
> that simple message, so that people understand that and change their
> behavior to follow that in ways that protects their house.
>
> Following that, in 2004, we, in FDA, will actively engage in getting
> this message out. We
>
> have not yet sat down and worked out all the various ways in which we
> are going to do it, we have just been working on the draft advisory,
> but we recognize that getting an advisory done is just the first step.
> The next 10 steps is in the effective implementation.
>
> With that, I think that closes this presentation.
>
> DR. MILLER: Thank you.
>
> **Questions of Clarification**
>
> DR. ACHOLONU: I noticed that in your presentation, Item 7 has what is
> mercury. I have a copy of the draft advisory here. It does not
> indicate what mercury is, but goes on to say, \"Mercury occurs
> naturally in the environment.\" Don\'t you think that you should
> include what mercury is?
>
> MR. PENDERGAST: That is a good point on here, and I actually said it
> myself, showing a little bit of what I know, that mercury is an
> element. It might help to start off with saying that.
>
> DR. MILLER: Dr. Scherer.
>
> DR. SCHERER: I would like to first congratulate you on all the work
> you have done in terms of structuring the message, because I think
> often we end up with messages that people just write and think that\'s
> the way it should be done, so that you have had a lot of input into
> the message.
>
> You seem to have arrived at a message that is understandable by focus
> groups, but I wonder if there is a point at which, in a sense, we have
> simplified a bit beyond meaning. Let me try to explain what I am
> talking about.
>
> I guess I am one that advocates that we need to simplify messages for
> people to understand, but if we lose what the science and the meaning
> is about, then, I have concerns.
>
> The message essentially says do not eat the same type of fish each
> week, and I understand why the message is that we should eat a mixed
> grouping of fish, but as a consumer I look at it and say wait, I eat
> trout, and I look at the list,
>
> and if I eat anything other than trout, I am increasing my intake of
> methylmercury.
>
> So, somewhere I may be losing some of what the message is trying to
> do. Does that make sense to what I am asking?
>
> MR. PENDERGAST: It does, and I think we thought about this at the same
> time, how do you get that type of information in people\'s hands for
> making decisions. That led us to developing the database or the list
> of what we know about levels of mercury in fish and to make that
> available, so that in the case that if you ate trout, and you would be
> looking for something that was lower in mercury.
>
> DR. ACHESON: My perspective on that is this is a balance between once
> you have eaten your portion of trout, you think, well, I know fish is
> good for me, what should I do next, and the idea would be that you
> would have something else that week.
>
> If you really want to go and investigate, you could look up on the web
> and say, okay, I
>
> really want to keep it low, which is why we have also gone for the 12
> ounces, because we figured that if you have had your portion of trout,
> say, 6 ounces, and you want to eat another serving of fish, another 6
> ounces of something, so long as you have got the mix-it-up message,
> you are going to go for something different, and it will still keep
> you safe even if you don\'t want to go and investigate.
>
> Then, you can certainly eat trout again the following week. This is
> sort of going week by week. But I agree with you, it is difficult to
> keep it understandably simple and yet not lose the science. We have
> tried to get that balance and certainly if you have some perspectives
> that could help ensure we maintain that, we would love to hear them.
>
> DR. MILLER: Dr. Krinsky.
>
> DR. KRINSKY: It seems to me there is a huge difference between reading
> the advisory and listening to the presentation that Dr. Pendergast
> gave, and listening to it makes it so much clearer if I try to put
> myself in the position of a
>
> consumer, of a pregnant woman or something of that nature.
>
> So, I just wonder, in the focus groups, were they simply given the
> draft advisory without any comment from the individual who was
> administering the focus group. I don\'t know how focus groups
> function, so I just wonder if I could get some clarification on that.
>
> MR. PENDERGAST: Yes. The way that the focus group worked, and the
> participants were in a room with a moderator. The moderator read the
> advisory, that current version of the advisory, and then people
> reacted to that. There was no explanation that was given by the
> moderator.
>
> We did break it up into two parts. The first part was the risk message
> with the consumer advice as one part, and then the participants
> discussed that. Then, we went for the Q\'s and A\'s.
>
> What we learned from that part was that a number of the questions that
> people had popped up when they read the advice, like isn\'t it good
> for me, isn\'t fish good for me, and things like that,
>
> and the Q\'s and A\'s then answered those questions on there, but
> there wasn\'t any explanation by the FDA, EPA, or the moderator as the
> focus group went on.
>
> DR. KRINSKY: So, the focus group was given the full document that we
> were presented with.
>
> MR. PENDERGAST: They were given the version at that time, the draft
> advisory evolved. The group in Calverton, which is the first one, had
> the first iteration of it, and then we learned from that. We made a
> second version, and then the group in New Orleans had the second
> version. We learned from that and made some revisions to it, then,
> Seattle, and then revisions, and then Minneapolis.
>
> So, what you see is the culmination of four iterations and learning
> from the four groups.
>
> DR. KRINSKY: So, how many focus groups received the document that we
> are reading now?
>
> MR. PENDERGAST: The precise document?
>
> DR. KRINSKY: The precise document that we received.
>
> MR. PENDERGAST: None of them, because this represents the last change
> from the Minneapolis one, however, the change from Minneapolis to what
> you see in front of you was very small. The largest change was after
> the first group, and the groups in New Orleans was the second group,
> saw pretty much the same language, the three parts of the message, the
> Do Not Eat, the 12 ounces and mix it up, how to integrate the local
> advisories, they saw that.
>
> Where we spent most of time in the revisions was in the ordering of
> the questions and precisely which questions.
>
> DR. KRINSKY: Thank you.
>
> DR. DOWNER: Thanks for a very informative presentation. I decided to
> take in a few of my teaching tools for my consumers and patients to
> let the committee see what a serving of tuna looks like, and this is
> not a lot.
>
> So, when we are hearing 12 ounces, 12 ounces compared, for example, to
> 3 ounces of hamburger patty, it looks a little bit more
>
> substantial than this 3 ounces or this quarter cup rather, of tuna. It
> is not a lot of tuna.
>
> My challenge is in talking to patients about increasing their fish
> consumption, when you hear limit, along with it you hear avoid, and
> that is a big challenge. That is the big challenge, how do we get the
> message out to say yes, we say to limit, not avoid.
>
> So, the slide that says how much fish to eat, the consumer advice, how
> much fish to eat, do not eat shark, swordfish, I would like that slide
> to include what to eat. The method is too far removed.
>
> The very slide that says do not eat so-and-so, I urge you to put
> instead eat so-and-so, et cetera, and you can give a reference to
> where they can go on to get other information, because it is easy to
> just look at this and say oh, I give up, I give up.
>
> One week you say or one year you say eat more fish and cut out the red
> meat, the next time I am hearing eat less of this, I am confused, so I
>
> give up. So, I urge you on this very slide that says do not eat shark,
> put the positive message with it. That is the only thing, as consumers
> and as clinicians\--I am a nutritionist in clinical practice\--will
> give to my patients and say here, this is the other side of this.
>
> MR. PENDERGAST: Thank you.
>
> DR. MILLER: Do you have another comment?
>
> MR. PENDERGAST: No, I think that is a good piece of advice for us to
> consider.
>
> DR. MILLER: Jean.
>
> MS. HALLORAN: If I understood the presentations correctly yesterday,
> from the exposure analysis, I think it was quite clear that you
> actually, for 98 percent of the population, can achieve the desired
> exposure only if you eat 12 ounces of low mercury fish, and it won\'t
> work if you are mixing it up with middle mercury fish.
>
> So, is it correct that if you, for example, had grouper, orange
> roughy, and albacore tuna for your mixed-up variety that week, isn\'t
> it correct that you would be over the reference dose?
>
> DR. ACHESON: The short answer to your question is if you were to eat
> grouper\--what was the\--
>
> MS. HALLORAN: Orange roughy and albacore.
>
> DR. ACHESON: Yes, and if you were to eat 4 ounces of those, based on
> the means, you would be over the RfD, yes. We regard the RfD as an
> important guideline as to where to target.
>
> As the discussion has gone on, what we are trying to do here is to
> achieve a balance between the health benefits of fish and the dangers
> of methylmercury.
>
> The exposure assessment is a model and it was a very useful guide to
> keep us on track. What we took from the exposure assessment was that
> if we can get the word out, we will be improving over current
> baselines.
>
> We may not get everybody below the RfD, but we will do better.
>
> MS. HALLORAN: But you are quite definitive in the advice. You say you
> can safely eat, safely eat, and yet it seems to me your
>
> analysis shows actually that you can only really safely eat the bottom
> 20 fish, so I would actually like to second the suggestion of Goulda
> that perhaps you could say safely eat 12 ounces of low mercury fish
> and then list half a dozen of them, and encourage eating those,
> because it is quite a long list.
>
> DR. MILLER: Dr. Dickinson.
>
> DR. DICKINSON: A lot of people are eating more fish now because of
> concerns about omega-3 fatty acids, getting more omega 3 fatty acids,
> and, in particular, they are turning to salmon, because they all know
> that salmon is one of the high sources of omega-3\'s, and fortunately,
> salmon is also one of the low category for methylmercury.
>
> So, it seems to me that it would be very beneficial for people to know
> that even several servings a week of salmon would not put them above
> that level, and if that means giving them more advice on the entire
> selection of low mercury fish, I think that would be very positive,
> but, in particular, I think they should know that salmon is
>
> one of those low mercury fish, and that if they are seeking to
> increase their omega-3 levels through eating salmon, they can safely
> do that.
>
> In fact, I think it is not quite true what it says about not eating
> the same fish more than once a week, because if you are eating from
> the low end of the list, and, in particular, if you are eating salmon,
> you may be quite well off eating more than one serving of those kinds
> of fish a week.
>
> DR. ACHESON: Those are excellent points. The first draft that we
> tested, we put in a list of low fish, included salmon, light tuna. It
> didn\'t work, people didn\'t understand it.
>
> What we are hearing here is somewhat of the same thought process that
> we went through - why don\'t you list them, why don\'t you do this,
> and where we have tried to end up with is a balance between what is
> understandable and what people can do considering this is a national
> advisory.
>
> We have certainly gone down that road of, well, let\'s list
> everything.
>
> DR. DICKINSON: But there is a difference between listing everything
> and mentioning the two or three things that people eat the most of,
> and salmon is one of those.
>
> DR. ACHESON: I agree with you, and that is exactly what we did in the
> first draft. If you look at the first draft\--I forget which tab it is
> in the notebook\--but where we have those three drafts in there, that
> is in there, in our variety explanation, and the focus groups didn\'t
> understand it.
>
> DR. DICKINSON: Well, that may have to do with the way it was said, as
> well as with the message itself, but I think that is worth another
> look.
>
> DR. ACHESON: Thank you.
>
> DR. MILLER: Dr. Durst.
>
> DR. DURST: I just have a few comments, several of them. I agree
> completely with my colleagues that my first reaction when it talked
> about mixing the varieties of fish was that it added confusion to me
> and, just to reiterate, that
>
> if you pick low mercury-containing fish, you can eat as much of that
> as you want without having to mix the species. So, I think that phrase
> in there is more confusing than helpful.
>
> On the point of mercury and what it is, the way it is stated in here,
> mercury occurs naturally in the environment, it is really mercury
> compounds, it is not the element, it doesn\'t exist in nature, so I am
> not sure if we want to get into all the science of it, that it\'s an
> element, which would be more or less meaningless to most of the
> population.
>
> I also agree that the three rules, the positive points should be
> emphasized, No. 2 maybe moved to No. 1, and I would recommend dropping
> out the mixing of the types.
>
> Finally, I think in presenting this in the final document, it would be
> nice to highlight just important aspects of it. There is a lot of
> verbiage in here that the consumer might be interested in, but they
> are going to see a two-page document that is going to be intimidating
> to most
>
> people who won\'t want to read through the whole thing, but if you
> highlight and bold in some way some of the main points, this might
> actually get the message across.
>
> Then, if the people want more information, they can read the fine
> print, if you will.
>
> I would also like to see some kind of a listing of the fish with the
> ranking as far as the amount of methylmercury in them. One of the
> documents we were given this morning from the Consumer\'s Union has a
> nice table of that sort, and I would recommend providing at least that
> kind of information.
>
> MR. PENDERGAST: Those are very good thoughts in there. Those are some
> of the things that we are also wrestling with is that, how much
> information can you put out before people stop reading.
>
> That is what led to the format that you have in front of you, where I
> think in one of the first iterations, some of those questions and
> answers for part of the verbiage of the advisory,
>
> and people in the first focus group could not get past that.
>
> They had gotten to that first paragraph, which is about what was
> mercury and where is it in the environment, and then they started
> getting worried, because they never got to the actual advice.
>
> Some thoughts, you know, I appreciate thoughts in terms of how to help
> focus people to where the thoughts are in there. We also had some
> thoughts about, you know, putting the information about fish and
> methylmercury content in the fish.
>
> That table, in itself, could depending on the number of species in
> there. Again, since it is national advice, we want to be able not just
> to give examples, but to be able to give all the information you have,
> because people eat different types of fish.
>
> We agonized over how to do that and came up with having a web site
> where not only would we be able to put a longer list on there, we
> would be able to update it. Instead of having to have
>
> printed advisories out and have to continually change what is in
> print, we would be able to continually change what is there on the
> website, so people would have the most current information.
>
> DR. DURST: Well, the only problem with the website, it is only going
> to hit a certain portion of the population, not the poorest segments
> and that sort of thing, so I think the website is nice for the
> Internet-active type people, but it is going to miss an important
> segment of the population.
>
> DR. MILLER: Dr. Russell.
>
> DR. RUSSELL: I actually liked the advisory very much, I think it is
> quite clear. I think it can be tweaked some, but I think it is a
> really good job.
>
> I wondered, however, there is just one little thing that came up in my
> mind, why, at one point, 12 ounces is defined as two to three meals,
> whereas, 6 ounces is defined clearly as one meal per week. I just
> wondered why the two to three if you are trying to make the message
> very clear.
>
> MR. PENDERGAST: That is a good point. Do you know that meals depending
> upon\--are people\'s choice. I know that my wife\'s meal and my meal
> are different sizes on there.
>
> DR. RUSSELL: I realize that, but in trying to make it clear, I just
> wonder whether people would start thinking is it three I could eat, or
> two, or one, or I can\'t remember.
>
> MR. PENDERGAST: That is a good point. We will really consider that
> one.
>
> DR. MILLER: Dr. Aposhian.
>
> DR. APOSHIAN: I just have three comments I would like to make. I agree
> with Dr. Krinsky as to the presentation seemed to be different than
> the advisory. I have lost count because I was interested in what
> someone else said. You mentioned tuna fish many more times in your
> presentation than it is mentioned and cautioned about in the advisory.
> That is number one.
>
> Number two, as Dr. Durst was saying, the poor group, the uneducated
> group, if you will, the immigrant group, if you will, may not read
>
> something this long. I think we have two extremes.
>
> You have the Ph.D./M.D. who is so busy that he is just going to read
> the first line, and then you have the poor people who either have to
> work for a living and don\'t have the time, but you ought to read the
> paper that the good people from the EPA have put out on environmental
> health perspectives, and it points out that as far as racial or ethnic
> groups are concerned, Asians, Native Americans, and Pacific Island
> women have anywhere from at least about one point times higher amounts
> of methylmercury than do the so-called white Caucasian American.
>
> So, I think what Dr. Durst was saying is to reach that group that is
> not as highly educated, that may not have the time or the desire to
> read something this long, my suggestion would be, as Dr. Durst made
> with highlighting, is maybe even using bullet statements that will get
> across.
>
> I have one more comment, that I hope an FDA attorney looks at the
> consumer advice that says benefits and risks. If you follow advice
> given by
>
> FDA and EPA, you will gain the positive benefits of eating fish, but
> avoid any developmental problems from mercury in fish.
>
> I don\'t testify in court anymore, it is just too much trouble, but
> that would just increase the consulting fees of most toxicologists
> that I know that do go before court, and I think that is a very
> dangerous statement for a governmental organization to make.
>
> MR. PENDERGAST: I appreciate the advice on there. That is something
> that I know that attorneys would take a look at.
>
> Getting to your comment about the length of the advice and message,
> that is something we also think about on here. As we get into the
> implementation in terms of how does this message get out, certainly we
> know that people will be taking it, paraphrasing it, putting it into
> publications.
>
> Within EPA, we have worked joint with ATSDR in terms of getting
> pamphlets out in the hands of pediatricians and OB-GYNs to be able to
>
> help pass the message on. We even have pamphlets in Vietnamese, Hmong,
> Spanish, and other languages to be able to get to the people who
> actually eat higher fish than the national median to be able to get
> the message out in their language that they best understand, to be
> able to do that.
>
> We are going to be looking at doing some of those same things because
> the important thing is to be able to have something which then helps
> generate the various different ways in which the message can go out,
> you know, press, consumer advisories by states, pamphlets we put out,
> pamphlets states put out.
>
> That is going to be where taking that message and putting it into real
> terms is going to make the difference.
>
> DR. MILLER: Dr. Scherer.
>
> DR. SCHERER: Just a few minutes ago there was some discussion about
> the advisory starting off with, \"Do not eat shark, swordfish,
> mackerel,\" and so forth. There is a phenomenon known as primacy and
> recency meaning that when we are hearing
>
> information, we tend to remember the first and the last.
>
> So, it would seem to me that some attention really needs to be given
> to how the advisory is organized, because it seems to me that starting
> out with \"Do not eat\" says that\'s the most important part, and if
> that is what we want people to remember, that is the part of the
> message they will remember.
>
> On another topic, thinking about\--and I keep going back to the idea
> of the behavioral, because it seems to me that that is really our
> bottom line. If people go away from this being confused because of the
> complexity of the message, as simplified as it is, we still haven\'t
> succeeded, and I wonder why you haven\'t gone to something like\--I am
> looking at the Minnesota one that is here in front of me\--that gives
> the simple behavioral rules to follow when you are interested in
> consuming fish.
>
> Most people, most of us have very simple behavioral rules that we
> follow. When you go to
>
> the grocery store, you don\'t go through all of the cereal reading the
> labels to decide what you want. You have a very simple behavioral rule
> what you are looking for, and it is probably a particular brand.
>
> So, I wonder if the kind of structure that the Minnesota one uses,
> that is giving those very simple behavioral rules would not serve a
> majority of the people better than a longer narrative kind of
> description.
>
> Secondly, it seems to me that we have to keep in mind, and some of you
> hinted at it, that all the consumers aren\'t the same. Some want those
> very simple behavioral rules. Other people do want more the arguments
> about why should I follow those behavioral rules, and still others in
> this room want data.
>
> So, the levels need to be there to the extent possible, and it seems
> to me that you were mentioning the web, that despite the fact that we
> could argue that the web will not serve most consumers, there will be
> consumers that want that depth of information, and it should be
> available on
>
> the web.
>
> So, I think the kind of linkage between the levels of message, in fact
> I would even include the web link right in the message, so that people
> who want more information can go and get that message.
>
> But I guess my real question is whether you have given some thought to
> trying to come up with a behavioral structure of a message here is the
> kind of advice that is given specifically.
>
> This is talking about if you eat two to three meals of fish per week,
> they can be from this group or this group.
>
> DR. MILLER: Dr. Dwyer.
>
> DR. DWYER: Thank you. I share Dr. Russell\'s concern about portion
> size, and I think it would help if all government materials used the
> same portion sizes. I know FDA, USDA, and other agencies sometimes use
> different ones, so we have to get on the same page particularly in the
> same advisory on a portion size, but it should be uniform with what
> other government agencies are
>
> doing.
>
> It seems to me there are four forks in this advisory. The first is are
> you pregnant or lactating or a young child, and that M.D./Ph.D. guy
> that you were talking about would go and he could eat all the fish he
> wanted, but if the answer is yes, then, the next thing is this
> business of no big fish, the four big ones.
>
> I think in the previous two or three days we spent on this, we talked
> about common names, and there are common names for some of them, and
> they are not in this. I imagine you will tell me that, well, this is
> for the nation and therefore the common names change from one place to
> another, therefore, we won\'t put the common names in, but it seems to
> me if it\'s consumer communication, you are going to have to, so it\'s
> no big fish is the second fork in the road.
>
> Then, it seems to me\--maybe I am still confused about this
> advisory\--that then there is a fork\--back to this behavior stuff
> that Dr. Cliff was talking about\--I don\'t think most people really
>
> call their local health department and check about advisories, so you
> have to have a rule for those lazy people like me.
>
> That would be I think you have said it\'s no more than 6 ounces\--if
> you don\'t know in the advisory\--it\'s no more than 6 ounces of game
> or sport-caught fish. Right?
>
> DR. SCHERER: Right.
>
> DR. DWYER: Then, the last fork in the road is this one on variety, and
> it\'s something, 12 ounces of variety of other fish a week. The
> problem I have got is that I am not going to do that. Now, hopefully,
> I am not going to get pregnant either.
>
> \[Laughter.\]
>
> DR. DWYER: I am not going to do that. I want advice about the fish
> that I eat, and the fish I eat unfortunately are those available in
> cafeterias, and it tends to be something, I can\'t tell what it is
> because it is covered with mayonnaise, but it is probably some kind of
> tuna fish, and it is probably like tuna fish.
>
> So, I want something more specific than that, that variety message
> there, because I am not going to change my consumption. I want to know
> what I am going to do within the consumption. I think it is highly
> unrealistic to think that we can change people\'s consumption to
> orange roughly or to something else away from these other fish.
>
> So, the common names, the serving size, the fact that people don\'t
> mix things up even though we want them to, the issue of too much
> verbiage. If you think about it, the Ten Commandments are about a
> third or less or maybe a tenth of the list of this advisory, not that
> people follow that behavior either.
>
> \[Laughter.\]
>
> DR. DWYER: Then, the final issue about there are other groups and
> other agencies of government. Certainly I don\'t want to hang crepe
> around fish, but the point is I don\'t think that FDA\'s first mandate
> is to promote fish. I think the first mandate it to promote the public
> health, and in this specific case, to avoid a contaminant,
>
> so I am more concerned about that than I am these other things.
>
> I think other folks and other parts of the government and other kinds
> of advice are going to get that larger and important message as well
> out.
>
> MR. PENDERGAST: Thanks.
>
> DR. MILLER: Dr. Waslien.
>
> DR. WASLIEN: I follow on what my colleague said, but I am not all
> together sure that the message gets out that not everyone in the
> household should drop fish. The first point doesn\'t say that for
> everybody else it is okay, it just says for women.
>
> I think that one of the comments that was made even by the group
> talking about the focus group presentations says, well, then, we have
> dropped fish, and they haven\'t dropped it just for the woman or even
> for the children, they are dropping it for everyone.
>
> What made me also react is, you know, this Washington Post made a
> comment that the Bush Administration is changing the regulations on
>
> pollution, and it says in there that the mercury is a threat to public
> health, to all public health, especially for children and mothers, but
> that means it\'s a threat to everybody else, too.
>
> So, the message gets out that mercury is bad and you shouldn\'t eat
> fish. That is for everyone. In fact, all of us who didn\'t eat fish
> last night were part of that group.
>
> The second group that I want to identify is my own constituency, the
> Pacific Islanders and Asians that are present in Hawaii. For Pacific
> Islanders, fish is it, there is no chicken, there is no meat.
>
> I spent a month in Micronesia and tuna is it, it is the only meat
> source available, and we need to look at that group, as well as Native
> Americans, as a potential message that has to be delivered.
>
> The third point is, is there some way
>
> for\--and I know this isn\'t a policy meeting\--that industry or food
> stores or restaurants can be involved in this, or if they should,
> because that
>
> is always a question, of identifying the low mercury fish for their
> public, because when you eat in a cafeteria line, you don\'t know what
> the fish is, but I don\'t know how that message can be set up and that
> is not the topic of this meeting, but certainly there will be industry
> people who follow up on that and identify the low mercury fish for us
> hopefully.
>
> MR. PENDERGAST: If I could add something to your last thought, that is
> somewhat the thoughts that we had on implementation is how do you get
> the message out and where do you get the message out.
>
> Some of our thoughts include working with grocery retail chains,
> working with restaurants, and even working within our own agency and
> what we serve our senior executives at their annual dinner, they had a
> choice between\--was it steak and swordfish on there\--so we have a
> lot to do in terms of how do we get the message out.
>
> In this case, it is caterers, and those are the things that we will be
> looking at and considering as we do the implementation step.
>
> DR. DOWNER: How many people chose the swordfish?
>
> \[Laughter.\]
>
> DR. ACHESON: Can I just respond to the issue of subpopulations? I
> don\'t think you can answer your question about swordfish, maybe no
> data.
>
> One of the things that we recognize is that we are striving to develop
> a national advisory. The studies out of NHANES and CDC have told us on
> \'99 to 2000 that 7.8 percent of the population had mercury above the
> RfD.
>
> One of our goals at FDA, working with EPA, is to better identify who
> these people are. The NHANES data isn\'t powerful enough to give us a
> really good insight as to who these people are, what they are
> consuming, what their habits are. Some of them who are above the RfD
> profess not to eat fish at all, so we are dealing with other things,
> as well.
>
> As we move forward on this, one of our goals at FDA is to develop
> programs to better
>
> identify who this susceptible population is ethnically, et cetera,
> geographically, so that we can develop targeted advice.
>
> This is a theme that has come up from a number of the committee
> members of should we target some people more than others, and it is
> our intent to try to develop those data, so that we can move in that
> direction, but frankly, we are not there yet, but it is one of our
> goals.
>
> DR. MILLER: Did you want to make an announcement about something,
> Johanna?
>
> DR. DWYER: No, I wanted to ask a question.
>
> I wondered if you could, Dr. Acheson, just what you were talking about
> with the percent above a certain level of mercury in the blood.
>
> DR. ACHESON: I am referring there to the NHANES work.
>
> DR. DWYER: What is the variability there, is there just one measure of
> serum or blood mercury that they have?
>
> DR. ACHESON: I believe so, one measure
>
> per person, I believe that is what it is, but obviously, those data\--
>
> DR. DWYER: You could only get cells, right? You can get like age, sex
> cells or something?
>
> DR. ACHESON: You can get broadbrush strokes on did you eat fish in the
> last 30 days, but we are not getting information on what kind of fish
> was that, do you eat sports-caught fish.
>
> DR. DWYER: Are you revising those questions, those items for the 2005
> survey?
>
> DR. ACHESON: Yes. That is part of where we want to go, but that is not
> going to give us answers until 2007 or 2008. I am a little more
> anxious than that.
>
> DR. APOSHIAN: There are people in the audience that can answer Dr.
> Dwyer\'s question as to how many blood samples were taken, there are
> people that were involved in that study in the audience.
>
> DR. MILLER: Why don\'t we have a break and then we will come back to
> the discussion. I think the discussion here indicates exactly how
> complex
>
> the situation is. That is what I heard not only from members of the
> committee that the advisory is too complicated, that it is not
> complicated enough even from the same person.
>
> I might point out to Johanna that the debates over the Ten
> Commandments have continued and maybe it\'s too simple.
>
> DR. DWYER: Thank you, Dr. Miller.
>
> DR. MILLER: We will come back in about 10 minutes.
>
> \[Break.\]
>
> DR. MILLER: Unless there are some vital issues that members of the
> committee want to raise to the presenters, I would like to move on to
> the public comment section of the discussion on methylmercury.
>
> DR. ACHOLONU: I have a comment to make.
>
> DR. MILLER: Yes, of course.
>
> DR. ACHOLONU: Thank you, sir.
>
> I am compelled to make a comment about this. I looked through the list
> of mercury levels in various fish presented to us yesterday, and I
>
> anxiously went through to see the fish called codfish, c-o-d, codfish,
> and I didn\'t see it here.
>
> This is a sort of a follow-up question or comment to Dr. Waslien\'s,
> who comes from Hawaii. This fish is eaten a lot by people from the
> Caribbean Islands and people from Africa, and as a matter of fact,
> this fish is being shipped from Norway, and many of the Africans here
> eat it almost every day, and I find that it is not on the list.
>
> I am concerned about it. Could we be told if any examination has been
> made of this to find out if it has a high level of methylmercury,
> because not too long ago, in Houston, Texas, some people ate this and
> it caused some death, and which I know.
>
> Forgive me for bringing this into discussion. I would like this to be
> addressed, where does codfish stand with respect to mercury level
> content.
>
> DR. MILLER: David.
>
> DR. ACHESON: Yes, Dr. Miller, with pleasure.
>
> Again, to reiterate, the data that I presented yesterday and the new
> data versus the old data is a subset of the total information that we
> have in our possession.
>
> That table was constructed to compare the recent assignment of the 12
> fish with the old data on those same 12 fish. We have a lot of data on
> other fish that are not in that list of 12 including codfish.
>
> I refer you to the latter part of your folders where there is a copy
> of the exposure assessment, which actually on Table 2, I believe,
> lists a lot of the other fish data that we have. I just took a quick
> look at it. I think the mean mercury level on codfish was 0.143.
>
> So, please don\'t assume that that list of 12 is all that we have data
> on. Hopefully, I made that clear yesterday, but obviously, failed to
> do so. We have a lot more data and we use it.
>
> DR. ACHOLONU: I used the word \"codfish.\" It is called stockfish,
> s-t-o-c-k, stockfish. Some people say that stockfish may be a kind of
> codfish,
>
> it is really not codfish, called stockfish.
>
> Also, we have this codfish that is salted fish eaten by the Caribbean
> people. They have what they call aki, salted fish, and it\'s a form of
> this stockfish, so you may want to find out if stockfish is the same
> as codfish.
>
> DR. ACHESON: We would have to look into that as to exactly what
> stockfish is. We will have to ask a fish expert.
>
> DR. MILLER: This is one of the big problems with this, that not only
> are there different names for the same fish in different areas, but
> even there are different fish that have the same name. Halibut in one
> part of the world is not the same fish as halibut in another part of
> the world.
>
> It is really an incredible task, and I think that compromises are
> going to have to be made between the complexity of precision and the
> ability to make these things understanding for the bulk of the
> population we want to reach.
>
> **Public Comments**
>
> We now turn to the public comment part of this meeting having to do
> with methylmercury. Before we do, there are a couple of administrative
> issues.
>
> First, I have been asked to read the statement which you have heard
> before in other areas of discussion, but in order to get it in the
> record and to remind each of the speakers that they have to fulfill
> the transparency requirements of our rules for this committee
>
> Both the Food and Drug Administration and the public believe in a
> transparent process for information gathering and decisionmaking. To
> ensure such transparency at the open public hearing session of the
> Advisory Committee meeting, FDA believes that it is important to
> understand the context of an individual\'s presentation.
>
> For this reason, FDA encourages you, the open public hearing speaker,
> at the beginning of your written or oral statement to advise the
> committee of any financial relationship that you may have with the
> sponsor, its product, and its
>
> known direct competitors.
>
> For example, the financial information may include the sponsor\'s
> payment of your travel, lodging, or other expenses in connection with
> your attendance at this meeting.
>
> Likewise, FDA encourages you at the beginning of your statement to
> advise the committee if you do not have any such financial
> relationships. If you choose not to address this issue of financial
> relationships at the beginning of your statement, it will not preclude
> you from speaking, but I encourage you to do so.
>
> The second issue is to remind you that we have a very tight time
> schedule and we are going to stick to the time required. Most of the
> speakers have five minutes. A few have asked for and we have decided
> to allow them to have eight minutes, but whatever the time that has
> been assigned, please keep to your time, so that we can finish this
> up. The committee has a long discussion ahead of it afterwards.
>
> Also, I would ask the committee to try and
>
> keep your questions for these public speakers short and to the point
> of the discussion rather than trying to bring up other issues that we
> have already discussed or we will discuss later on.
>
> The first speaker is Susan West Marmagas.
>
> MS. MARMAGAS: Good morning. My name is Susan West Marmagas and I am
> the Environment and Health Director with Physicians for Social
> Responsibility.
>
> In keeping with the request of the Chair, I have no, and our
> organization has no, financial relationship with the sponsor of this
> meeting or the advisory.
>
> It is a pleasure to be with you this morning. Physicians for Social
> Responsibility is a national organization representing over 28,000
> physicians, other health providers, and concerned citizens.
>
> We work really on two fronts. One is we involve and educate the
> medical profession about a whole set of issues related to
> environmental health, of which mercury in fish is one, and we
>
> also are involved in protective, precautionary public health policy
> work at the state and national level, and it is really from that
> perspective that I speak to this committee this morning.
>
> We appreciate the opportunity to express our views. We were involved
> in the stakeholder meeting in July with FDA and EPA and have been
> closely following this issue because it is such an important public
> health issue and it is so important for clinicians. I am going to
> speak a little bit about the role of the clinician and the importance
> of advice for them as I get further into my comments.
>
> We, however, are deeply concerned about the advisory that is put
> forward this morning to you to consider. We think that it\'s the
> status quo that FDA has put forward and it really gives false
> assurance to the American people that this issue of fish\--we think it
> is false assurance on what is really safe in fish.
>
> Therefore, I am going to speak briefly on six concerns, criticisms,
> recommendations of this
>
> advisory and provide some guidance to you as a committee about how you
> might address those concerns.
>
> The first, and we heard a little bit about that this morning, is the
> issue of science. We know that a credible and health protective fish
> advisory must have a foundation in public health science.
>
> In the case of methylmercury, any advisory must be based on the EPA
> RfD, and we know that that is 0.1 micrograms per kilogram of body
> weight per day. As you know, the National Academy of Sciences endorsed
> this RfD in its 2000 report, calling it \"scientifically appropriate
> level for the protection of public health.\"
>
> In recent months, FDA has indicated that it will adopt and rely on the
> EPA RfD. However, the RfD is clearly not reflected in the draft fish
> consumption advisories before this committee.
>
> We are concerned and baffled why the RfD is not being followed in this
> case and being met, and even yesterday, Dr. Carrington, in speaking to
>
> this committee, acknowledged that the exposure assessment clearly
> indicates that the only way to ensure that 98 percent or more of the
> population remains below the RfD is to limit consumption to 6 ounces
> of a variety of fish\--this is minus the high risk fish\--or to limit
> consumption to 12 ounces of the low variety fish.
>
> So, therefore, we don\'t understand why this RfD is not being
> followed. We think it is both misleading and irresponsible of FDA not
> to follow and meet the RfD and we urge this committee that the FDA
> should do that in this advisory.
>
> The second area I want to talk about is children. In this new
> advisory, parents are urged vaguely to feed their children portions
> that are smaller than the 12 ounce recommended amount. What is
> \"smaller\"? We need to actually and I think we are able to think
> about how children are not just little adults and to model what is
> actually safe for children. We do this in other areas of child
> protective policy, let\'s do it with fish.
>
> Why has the agency not consulted with
>
> pediatricians, the American Academy of Pediatric experts who know how
> to model to protect children, and we would encourage that the FDA do
> that, because we believe that you can develop a formula for
> children\'s consumption that begins with the reference dose and
> accounts for the child\'s body weight and age and their neurological
> development.
>
> You might look at a life stage approach, and we would encourage the
> FDA, we encourage you to consider asking FDA to do this, so that we
> can give more specific guidance to parents on protecting children.
>
> The third area I want to address is tuna. Here, we believe very
> strongly that while the advisories note that canned albacore tuna is
> higher in mercury than canned light tuna, they are unexpectedly soft
> on this point. In fact, FDA\'s own new testing of methylmercury levels
> in canned tuna shows that albacore may contain up to three times as
> much mercury as light tuna.
>
> FDA must make this distinction clear to the American public. In
> addition, there is no
>
> clear guidance on canned tuna consumption. Eleven states now advise
> pregnant women and children to limit their consumption of canned tuna.
> We need to now do this at the national level. We need to provide
> federal guidance on the issue of tuna.
>
> The fourth issue, and I think the one nearest and dearest to the heart
> of my organization that represents clinicians, is that we are very
> concerned that there is conflicting and unclear advice, medical advice
> on how to deal with this issue.
>
> The advisory needs to clarify the potential effects. It equates
> so-called \"minor delays\" with medical condition, but it doesn\'t
> clearly talk about what that link is, so these
>
> so-called minor delays that we believe are serious are sort of equated
> with medical problem. There is a distinction that needs to be made in
> this advisory.
>
> In addition, the advisory assumes that health care professionals are
> prepared and ready to answer questions from their patients. It talks
> in
>
> this document about if you think you have been exposed to mercury,
> immediately seek advice from a health care provider.
>
> We believe that in order to avoid unnecessary concern from parents and
> to prepare health providers to really be part of the solution, that
> FDA needs to develop tailored and substantive guidance for clinicians.
>
> We recommend that FDA reconsider the following statement, \"If you
> have questions or think you have been exposed to methylmercury, see
> your doctor or health care provider immediately.\"
>
> We question this message for several reasons. First, the advisory has
> previously implied that everyone is exposed to some level of mercury
> since it is ubiquitous in our environment, so are we now saying that
> everybody should seek medical advice? We need to clarify that point.
>
> Second, health care providers are not prepared to answer questions
> from their patients without clinical guidance from EPA, and we believe
> it is incumbent to provide clinicians with more
>
> details on what they should offer to their patients.
>
> Finally, I want to conclude on my last fifth and sixth points, and we
> have heard this earlier today, we need to give an empowering message
> to the public and therefore, we need to talk about the low-level
> mercury fish. That information is not in here, and that is a great
> opportunity to say avoid these, these are where you can focus your
> attention. We think it is very important to highlight the low-level
> fish in this advisory.
>
> Finally, and I think this is very important, in one of the initial
> drafts of the advisory, there was a statement that said, \"There is no
> harm in eating more than the recommended amount of fish and shellfish
> in one week as long as you do not do it on a regular basis.\"
>
> This doesn\'t work for pregnant women and we strongly recommend that
> in here, it says, \"Pregnant women should be advised to follow the
> guidelines at all times, that at all times during
>
> pregnancy, they should reduce their exposure to fish that are high and
> moderately high in mercury.\"
>
> DR. MILLER: Ms. Marmagas, your time is up.
>
> MS. MARMAGAS: Thank you.
>
> We need to protect children and the fetus in their vulnerable windows
> of vulnerability and therefore all pregnant women throughout all of
> pregnancy should follow these guidelines.
>
> I thank you for your time.
>
> DR. MILLER: Any questions that need to be asked?
>
> If not, we will go to the next speaker, Dr. David Wallinga. You have
> eight minutes.
>
> DR. WALLINGA: I am Dr. David Wallinga. I am a physician with the
> Institute for Agriculture and Trade Policy in Minneapolis, Minnesota.
>
> Thank you very much to the committee for allowing me to speak. As with
> the previous speaker, my organization has no financial relationships
> with the sponsor of this meeting.
>
> I speak with many different hats including
>
> having carried out training around how physicians can give advice on
> fish consumption to almost 1,000 health professionals over the last
> couple of years.
>
> I also come with the hat of having helped prepare this consumer advice
> that we distributed to you, which is Minnesota-specific, but I think
> it has some interesting lessons, and then, thirdly, as a resident of
> Minnesota, which I believe has the most fish advisories of any state,
> most of those being for lakes, which are not mentioned in the
> advisory, by the way.
>
> Also, somebody had raised the issue of the states having to distribute
> advisory information. Minnesota prepares advisories, but its \$35,000
> a year budget for actually distributing it was cut.
>
> So, I wanted to applaud the committee and FDA for a couple of things,
> first, renewing their testing program and generating more
> comprehensive data, and also for trying to work jointly with EPA to
> come up with a single piece of advice.
>
> But I did have several concerns that are going to be echoing those of
> the previous speaker.
>
> As a physician, primarily, I want to point out some ways in which this
> advisory may make it harder for physicians to practice in a way that
> is consistent with their oath to do no harm.
>
> First of all, relative to serving sizes, I agree that the draft
> advisory is confusing on this score, and I wanted to just talk a
> little bit about Dr. Jane Hightower\'s data. She gave me permission to
> use some of this information, and she did this study that you are
> familiar with, looking at 123 patients of hers from a practice that
> sees about 700 patients a year.
>
> The patients in that sample had a number of fish meals that ranged
> from 3 1/2 to about 50 per month with an average being 18 per month or
> 4 per week, and they considered a serving size to be between 5 and 8
> ounces. Many of the restaurants they frequented served fish servings
> in that amount. So, I really think that this 12 ounces, whether it is
> 2 or 3 servings, it should reflect real life.
>
> I also noted the inconsistency between the
>
> serving size for the 12 ounces of seafood and the 6 ounces of
> freshwater fish, and that should be addressed.
>
> Second, I wanted to point what I did in this chart was to start again
> with the reference dose of 0.1 microgram per kilogram per day for a 60
> kilogram woman, equates with a 180 micrograms of mercury ingested per
> month, and I compared that to what the ingestion would be with fairly
> modest 6 ounce servings of these species, which is not as much as up
> to 12 ounces that is recommended, but is consistent with the advice to
> only eat one species a single time per week.
>
> As you see for grouper, orange roughy, Minnesota walleye, canned
> albacore, and for those species, they all exceed the reference dose
> amounts. In addition, just for yuks, for halibut, I looked at what
> would happen if you ate it eight times per month or, alternatively, a
> one-pound serving, and again you are over.
>
> As you can see, there is this disconnect between the reference dose
> and the advice that is
>
> actually given. I think the Environmental Working Group is going to
> talk about this later, but I wanted to just point that out.
>
> Patients don\'t eat fish based on just mercury, they want to know
> which fish are safe to eat, and they also want to, as was mentioned
> earlier, they see things holistically. I don\'t think this is too
> surprising. They want to know the totality of the fish that they can
> eat. Although the draft advisory mentions freshwater species, there is
> not much concrete advice about freshwater species.
>
> We attempted to do that in this report. We had combined information
> from both FDA, as well as state information data on PCB and mercury
> contamination for Minnesota fish.
>
> We did some others things, too. We had an expanded Do Not Eat list
> reflecting our belief that a 0.5 parts per million cutoff in terms of
> what people should have, and because many of the species that have
> been most recently tested by FDA have elevated levels above 0.5, we
> think that the draft
>
> advisory should have an expanded Do Not Eat list, but I would also
> point out that in Minnesota, PCB contamination including many of the
> low mercury species can result in fish advisories, and we should say
> something about predatory fish that are freshwater fish, like muskies,
> white bass, large walleye, and large pike.
>
> That didn\'t prevent us from starting off telling people what they can
> eat, and I think this is a very key point, that people are not
> confused or scared because of too much information, rather a lack of
> specific information, and we tried to empower consumers to find fish
> that are safe that they can eat.
>
> We added in some sustainability criteria that I don\'t think I will
> talk about, but that is what some of the coloring has to do with.
>
> Second of all or another point is that our advisory seeks to protect
> everybody, and I know you are familiar with this graph. This is from
> EPA\'s Children\'s Report, just depicts the CDC data, and so that is
> what a lot of us have been talking
>
> about, but obviously, the advice doesn\'t protect wealthier people who
> tend to be high-end consumers of fish, and maybe that can\'t be
> covered in this advisory, but perhaps this committee should recommend
> another advisory.
>
> It also doesn\'t reflect concerns for adults who don\'t plan on
> getting pregnant, namely, concerns for their cardiac health and people
> with cardiac disease.
>
> This is just to say, again data from Jane Hightower\'s study showing
> that a large percentage of the people that she looked at, and did
> mercury sampling for, had blood lead levels that exceeded, in some
> cases many fold, the maximum recommended blood mercury levels, and
> their hair levels were also elevated in some cases.
>
> What is this talk about cardiac toxicity, because again the advisory
> doesn\'t mention this at all. The literature about the
> cardioprotective effects of omega-3 fats is pretty good, but as the
> NAS also pointed out, there is much data from both animals and humans
> that exposure to methylmercury
>
> can have adverse effects on the developing and adult cardiovascular
> systems and that some research suggests that these adverse effects
> occur below levels associated with neurodevelopmental deficits.
>
> Here is again some other studies that they have talked about pointing
> out that just a 2-fold increase\--
>
> DR. MILLER: Dr. Wallinga, could you summarize, please.
>
> DR. WALLINGA: Yes. Let me just skip to the end. So, suggested
> changes - serving sizes should reflect real life, that in the upper
> limit of recommended fish consumption should be safe. We should
> empower patients by telling them what fish they can eat and don\'t
> insult the intelligence of the patients by assuming that it is more
> than they can handle.
>
> We should do more testing of fish that people can eat, and we should
> also test for pollutants other than mercury. Right now I have trouble
> finding any PCB or dioxin or flame retardant testing for fish in the
> FDA website.
>
> Finally, perhaps we need a separate advisory dealing with cardiac
> endpoints, so that, as a physician, we can give good advice to all our
> patients, and not just those expecting to get pregnant.
>
> Thank you.
>
> DR. MILLER: Any brief comments? Thank you.
>
> The next speaker, five minutes, is Caroline Smith DeWaal.
>
> MS. DeWAAL: Good morning. I have no financial ties with the sponsors
> of this meeting.
>
> I am Caroline Smith DeWaal and I represent 800,000 consumers who are
> members of CSPI and subscribers to Nutrition Action Health Letter.
>
> We actually put out consumer education to consumers 10 times a year on
> foods that they may want to purchase were very specific, and we have a
> lot of good advice, both for nutrition and also for food safety.
>
> We have been very supportive of this process and we appreciate the
> work that EPA and FDA
>
> have done to date. Just bringing the agencies together and agreeing on
> common language is progress.
>
> However, we are disappointed with the final consumer advisory, which I
> didn\'t see until yesterday morning, and in my remarks which are
> included in this paper, we talk about three draft advisories, which is
> what we saw prior to this meeting.
>
> Let me give you just one example of our concern regarding this
> advisory. I am going to read the risk message.
>
> \"The FDA and the EPA are advising pregnant women and nursing mothers
> to eat the types and amounts of fish and shellfish that are safe to
> prevent any harm to the developing nervous system of their baby or
> young children.\"
>
> That may mean something to other people, but I can tell you it
> doesn\'t mean a lot to me, and I think it doesn\'t mean a lot to the
> consumers that we are trying to communicate to. I think it is a double
> positive to communicate a warning message
>
> and it really doesn\'t work.
>
> In addition, I think one example that shows perhaps the way we got to
> that kind of message as being a risk message, which it isn\'t, may be
> in some misunderstandings of the people drafting it.
>
> For example, Dr. Acheson was quoted in the Washington Post this
> morning, saying that the advisory was implicit in telling at-risk
> women to eat more than 4 to 6 ounces of tuna per week.
>
> I mean in a consumer advisory, we cannot be implicit, we cannot have
> implicit messages. If that is an important message to at-risk women,
> it needs to be explicit.
>
> I have a couple of pieces of advice. We believe that the advisory
> needs significant redrafting in order to be effective, and I hope that
> the Food Advisory Committee can make some recommendations that will
> help get this advisory out quickly, but in a form that is much more
> effective.
>
> First of all, we would urge you to
>
> recommend to Commissioner McClellan that he convene a roundtable of
> experts from consumers, public health organizations, and the seafood
> industry early next year to make recommendations on the advisory.
>
> You might want to think about this as a stakeholder focus group. They
> are doing focus groups with average consumers. Perhaps they should do
> one with stakeholders and get very specific ideas for making
> improvements.
>
> Frankly, I think we could\--I have been working on this issue since
> 1991 when the National Academy of Sciences first criticized FDA\'s
> standard for methylmercury\--I think that I could sit down with
> members of the seafood industry and come up with a clearer, shorter,
> and more effective message.
>
> I think you also might want to recommend that they think about more
> than one advisory. There is the advisory to pregnant women, but there
> should be a separate advisory to the parents of young children.
>
> Children eat\--anyone who has children knows this\--if a child likes a
> food, they eat it all the time. If they like tuna, they are going to
> want tuna five days a week. We need to be very explicit with
> consumers, and in CSPI\'s Nutrition Action Health Letters, we actually
> published a list that has the weights of children and how much is safe
> to eat for canned tunafish.
>
> Again, these numbers need to be redone on the basis of the new data
> that FDA has developed, but giving parents very specific information
> about what is safe to eat I think is quite important.
>
> My third recommendation to the Advisory Committee is to ensure that
> the final advisory reflects the science. We heard yesterday from Dr.
> Carrington in the exposure assessment that really, the 12 ounces
> recommendation only goes to the seafood that contains low amounts of
> mercury, and not to many of the fish that are on the list.
>
> The better recommendation may be 6 ounces of seafood, not 12 ounces.
> In addition, the names of the fish aren\'t clear. My understanding is
>
> tilefish is actually frequently sold as golden snapper. So, getting
> the actual correct names of the fish in the advisory is very
> important.
>
> Again, I think a focus group of experts from the seafood industry and
> consumer communities might be able to work out some of these issues if
> it can\'t be done at FDA.
>
> DR. MILLER: Caroline, can you finish up, please.
>
> MS. DeWAAL: I can. finally, we would like to bring to the committee\'s
> attention another advisory which is in use in California. This is in
> your packet. I would urge every member of the committee to look at it.
>
> This is actually at point of purchase when you buy seafood in
> California, and it mentions salmon, shrimp, and scallops as the low
> risk seafood, the things that people can eat a lot of very safely, but
> this has a lot of good information and the information that the
> Advisory Committee has been asking for. So, if you look at this in our
> packet, this will I think also give you some ideas
>
> of how to do the advisory more effectively.
>
> Thank you very much.
>
> DR. MILLER: Thank you, Caroline.
>
> Any questions for her? Thank you.
>
> The next speaker is Carol Stroebel from Children\'s Environmental
> Health Network. Five minutes.
>
> MS. STROEBEL: Thank you. Thank you for this opportunity. My name is
> Carol Stroebel and I am representing the Children\'s Environmental
> Health Network, and although I am not a scientist myself, I am honored
> to be working with the nation\'s foremost researchers and clinicians
> in the field of children\'s environmental health through their
> participation in the Network.
>
> In terms of financial disclosure, my sole relevant financial
> relationship is the compensation I receive from the Network from the
> work I do for the Network.
>
> The Network was created to promote the incorporation of basic
> pediatric principles in policy and practice. My written statement
> includes
>
> these principles in detail, but I will summarize them now simply by
> urging you to always keep in mind that children have unique
> vulnerabilities, susceptibilities, and exposure.
>
> We have learned from sad experience that exposures to environmental
> toxicants that result in little or no harm to adults can lead to
> lifelong harm in children. The Network strongly urges you to help
> assure that these principles are applied in all FDA actions and
> policies, especially those that relate to methylmercury.
>
> We know that methylmercury is a potent developmental neurotoxicant.
> Thousands of U.S. children are estimated to be at risk from exposure
> to mercury, an estimated 60,000 infants each year from in-utero
> exposure alone. We have a responsibility to prevent these risks, and
> the FDA has a substantial responsibility in this regard.
>
> Certainly, what FDA and EPA and other government agencies communicate
> to the public is vital, and I will speak on that momentarily, but
> these decisions must also be made in the context of
>
> two paramount issues.
>
> One is that standards that are not adequately health-protective of
> children will place children at risk. Dietary advice, while vital, is,
> by itself, inadequate to eliminating the risk of methylmercury, and
> prevention of risk begins with a better understanding of the sources
> and levels of exposure. We cannot successfully undertake the task of
> keeping mercury out of our food chain if we do not monitor our foods
> for the presence of mercury.
>
> Thus, the Network strongly urges the FDA to adopt and enforce the
> NAS/EPA standard for the safety of methylmercury in fish. We have been
> heartened by the recent joint EPA and FDA discussions on mercury and
> we are hopeful that they will result in coordinated and
> health-protective standards for children.
>
> We commend the FDA for undertaking some increased monitoring of
> mercury levels in fish. However, we need to undertake a systematic
> monitoring of mercury in fish and in people, as
>
> part of a coordinated governmental effort to protect people from the
> harmful effects of mercury.
>
> In addition, other foods with known or potential mercury contamination
> must also be tracked and analyzed, so I want to take the opportunity
> today to mention another issue I hope that the committee considers.
>
> There is a recent analysis of baby foods by government agencies in the
> United Kingdom and it found a quarter of the samples contained mercury
> and that the average level of mercury in those foods was double that
> found three years earlier, and some babies were found to be consuming
> twice the amount that the U.S. EPA would deem safe for adults.
>
> The Network communicated to the FDA earlier this year and asking for
> them to undertake an analysis of baby foods. Unfortunately, the
> Network has yet to receive a response, so we request that you consider
> recommending that FDA also monitor these foods for mercury.
>
> In terms of the consumer advisories, our
>
> written comments also refer to the three draft advisories, not to the
> fourth version that we just saw this morning.
>
> The Network commends the FDA for the efforts it has undertaken to
> improve its consumption advisories, and we thank the Advisory
> Committee for the great leadership it has shown on these efforts.
>
> We wish to associate ourselves with the testimony and the materials
> developed by Consumers Union and by Physicians for Social
> Responsibility, and we urge the committee to carefully consider their
> proposals.
>
> In brief, we urge that all consumer advisories on methylmercury in
> fish and seafood reflect the following concepts:
>
> First of all, the advisories must be based in science; they should
> define what science indicates is a \"safe\" dose and provide advice
> that would keep consumers from exceeding the RfD. None of the draft
> advisories do so.
>
> The advisories should assure that all
>
> subpopulations at risk are targeted. Certainly, women of childbearing
> age must be targeted. But so must other groups at risk, particularly
> children. The draft advisory does not focus on children and is not
> specific enough for children. The draft advisory title, for example,
> says advice for women of a certain group about children.
>
> Children can safety consume far less fish than adults, and the
> advisories must clearly make this point, and advisories must make
> clear that even one-time high-end consumption - a spike in mercury
> exposure - could be harmful to children.
>
> Some advisories have mentioned a specific number of ounces that would
> be okay for adult consumption, but then used vague term, such as
> \"smaller\" when providing guidance related to children.
>
> DR. MILLER: Ms. Stroebel, could you summarize.
>
> MS. STROEBEL: Sure. The advisories should provide more information
> about different fish and seafood varieties, so that consumers are
>
> not given the impression that all species off the Do Not Eat list are
> equal, and the advisories should put health first even if it means a
> message to eat less tuna rather than a misguided statement that you
> can safely include tuna as part of your weekly fish consumption, which
> is not the case clearly for some part of the population.
>
> Thank you very much.
>
> DR. MILLER: Thank you.
>
> Yes.
>
> DR. APOSHIAN: I think your statement of 60,000 children at risk is
> extremely conservative. We have been all handed a copy of a
> peer-reviewed paper from the EPA group co-authored by Mahaffey,
> Clickner, and Joseph.
>
> In the summary on page 4, and I will just read the statement, \"Based
> on the distribution of blood mercury concentration among the adult
> female participants in 1999-2000 NHANES and the number of U.S. bursts
> in 2000, more than 300,000 newborns each year in the United States
> have been exposed in-utero to methylmercury concentrations higher
>
> than those considered to be without increased risk of adverse
> neurodevelopment effects associated with methylmercury exposure.\"
>
> The article, peer-reviewed journal by the EPA, that I think should not
> be ignored.
>
> DR. MILLER: Thank you.
>
> The next speaker is Robert Califf \[ph\] from the National Fisheries
> Institute.
>
> MR. CALIFF: Good morning. I would like to thank the Food and Drug
> Administration and the Environmental Protection Agency for the
> opportunity to address the Food Advisory Committee this morning.
>
> I represent the National Fisheries Institute, an Arlington, Virginia
> based nonprofit trade association representing the commercial fish and
> seafood industry, and we have no financial connection with the
> sponsors.
>
> NFI wishes to commend the Food Advisory Committee for its
> recommendations provided to FDA at the conclusion of the committee\'s
> meeting in July 2002. We also wish to acknowledge the work
>
> undertaken by FDA in response to the recommendations and the efforts
> by both agencies to develop a joint advisory for mercury and fish.
>
> In 2002, NFI made a presentation to the Advisory Committee with the
> assistance of Dr. William Connor of the Oregon Health and Science
> University. Dr. Connor provided a review of the scientific literature
> that shows the positive influence that fish and seafood has on
> nutrition and health status of U.S. consumers.
>
> Dr. Connor\'s review included the large body of scientific research on
> the cardioprotective effects of N3 fatty acids found in fish and the
> essentiality of N3 fatty acids in the development of the brain and
> retina during fetal growth and in babies after birth.
>
> In addition to this body of research, new information is emerging on
> N3 deficiencies and depression. In 2001, a paper was published in the
> Lancet by NIH researcher Dr. Joe Hiblin \[ph\], who observed that
> mothers transfer DHA to their fetuses to support neurological
> development during
>
> pregnancy, and further concluded that mothers without sufficient
> intake can become depleted of DHA, which may increase their risk of
> suffering major depressive symptoms in the postpartum period.
>
> I have begun my comments by mentioning this information to make the
> point that fish is not like tobacco or alcoholic beverages that carry
> risks with little or no health benefits to those who use them.
>
> We believe the benefits of fish consumption must be highlighted in
> explaining the mercury issue. Advisories should be educational
> messages that are easily understood and balanced regarding the risks
> and benefits associated with fish consumption.
>
> If they are not, we believe consumers will be confused, causing them
> to deselect fish from their diet. This would be unfortunate and
> perhaps harmful to consumers because they would lose the health
> benefits associated with fish consumption.
>
> There is some evidence that the release of the existing fish advisory
> and media coverage
>
> surrounding that release has already resulted in the decrease of
> consumption amongst pregnant women.
>
> Dr. Emily Oken of Howard Medical School and colleagues published a
> paper this year that showed an association between the release of the
> advisory and reduced consumption of tuna, dark meat fish and white
> meat fish alike in a cohort of 2235 pregnant women in Massachusetts.
>
> The authors concluded that the public health implications of these
> changes in consumption remain unclear because fish may confer
> nutritional benefits to mothers and infants.
>
> The study suggests to me that women may not understand the dietary
> changes may not be needed if they are already avoiding fish with the
> highest levels of methylmercury and are eating a variety of fish on
> average in the amounts recommended.
>
> There has been considerable discussion about whether the existing
> advisory goes far enough in warning women of childbearing years about
> methylmercury and making recommendations about fish
>
> to avoid.
>
> I think some context can be provided by looking at what some of the
> other developed nations around the world have done. In Canada, the
> recommended limit for swordfish, shark, fresh and frozen tuna is one
> meal per month for young children and women of childbearing age. The
> Canadian advisory notes that this restriction does not apply to canned
> tuna.
>
> In Australia and New Zealand, the current advice for pregnant women is
> to limit the consumption of shark, swordfish, and six other species to
> four portions per week. It also indicates that other fish, including
> canned tuna, can be consumed as often as desired, but consumers should
> eat a variety of fish.
>
> The health agencies in Australia and New Zealand have said that they
> are reviewing this advisory in part due to the establishment of a new
> WHO tolerable weekly intake that is intended to protect the developing
> fetus. The WHO\'s tolerable exposure level is a little more than
> double EPA\'s
>
> RFP.
>
> In June of this year, a news article in Japan indicated that the
> Japanese Ministry was advising pregnant women not to eat swordfish and
> alfonsen \[ph\] more than two times a week and to limit consumption of
> shark and sperm whale to no more than once a week.
>
> Interestingly, the article indicates that the Ministry said the
> consumption of fish does not pose a health problem to pregnant women,
> but despite that effort by the Ministry, the message conveyed to
> consumers resulted in a drop in the sale and price of alfonsen
> sharply.
>
> DR. MILLER: Could you summarize, please.
>
> MR. CALIFF: Thank you.
>
> In regard to the advisory itself, we would like to first commend the
> agencies on the work they have done to develop the joint advisory, to
> test it, and then to rework it based on focus group responses.
>
> We ask that agencies ensure the advisory provides adequate reassurance
> to consumers that
>
> fish is a healthy food choice that should be maintained in the diet.
> Finally, we urge the agencies to continue the careful process they
> have begun by testing the version of the advisory that they propose to
> use including the evaluation of the impacts of the advisory after it
> has been issued.
>
> Thank you for your time.
>
> DR. MILLER: Any questions or comments? Thank you.
>
> The next speaker is Dr. Ned Groth from Consumers Union. Eight minutes.
>
> DR. GROTH: Thank you very much, Mr. Chairman.
>
> Consumers Union is a not-for-profit testing and publishing
> organization supported by subscribers, of which we have about 5 1/2
> million.
>
> For those of you who don\'t know me, I am a biologist. My specialty is
> environmental health. I have been at CU for 24 years doing risk
> analysis, risk assessments, scientific research, and policy advocacy
> and risk communication on food safety and environmental health issues.
> In fact, I have been
>
> dealing with issues like this since Sandy was the head of the Bureau
> of Foods.
>
> We have a considerable amount of experience to share with you. I have
> distributed a written statement. I am going to highlight some key
> elements of that in the context of what I hope this committee can do
> today to help move this process forward.
>
> We think the FDA and EPA have come a long way, but there is still a
> lot of improvement needed in three particular areas I want to call to
> your attention and hope you will concur with.
>
> One is the advisory has to be based on sound science in terms of
> defining what is a safe intake. As we have heard in many ways, it is
> not at this point. It simply cannot say that it is okay to eat more
> fish that contains mercury that will give doses above the reference
> dose and call that safe.
>
> The reference dose is a definition of safety in that it means exposure
> below that is reasonably certain to pose no risk of harm, but
>
> above that, it is not certain it is harmful, it is just we are in the
> gray zone between knowing there is no risk with scientific reasonable
> certainty and knowing there is a risk.
>
> The gray zone is only a factor of 10Y in this case. It is not a huge
> safety factor. So, if you are talking about exposure that could be 3
> or 4 or 5 times above the RfD, which could happen with some of the
> fish meals that people are likely to be eating, we are way too close
> to the level where we know harm is likely, and we have to stick to a
> reasonably scientific and well-vetted definition of safety.
>
> The FDA has adopted the RfD, but it isn\'t reflected in this advice,
> and it has to be. So, I think that is point 1.
>
> Point 2 is about populations at risk and several people have already
> addressed that. I endorse what Carol Stroebel and David Wallinga and
> others have said about targeting advice to other groups we know are at
> risk, not merely pregnant women. Children as a separate group, yes;
> high-end
>
> fish eaters, I want to say some more about that.
>
> I have looked at the data on fish consumption from figure 2 of the
> Carrington and Bolger paper, and tried to read that graph. Right
> around the inflection point is where it gets interesting, but it
> appears that about 2 1/2 percent of the population consume more than
> 0.6 fish meals a day, which would be 4 fish meals a week, and if you
> go down to 0.5, it is about 5 percent of the population consumes half
> a fish meal a day or more, which would be 3 1/2 fish meals a week.
>
> When we consider portion size, which I will, I think it is reasonable
> to assume that those people are eating more than 12 ounces of fish a
> week. That means if we are talking about the population of the United
> States, 2 1/2 percent is about 7 million people, 5 percent would be 14
> million people. Not all of the people in the United States eat fish,
> but it is still a very large number of people we are talking about who
> eat more than, and can be reasonably expected to eat
>
> more than, 12 ounces of fish a week.
>
> I can just say anecdotally I have eaten more than 12 ounces of fish in
> a meal. If you go to Legal Seafood, at the prices they charge, and
> have a shrimp cocktail and a plate of scallops, you are getting 20
> ounces of seafood by my conservative estimate in one meal, and that is
> not unusual especially as someone mentioned, for wealthier consumers.
>
> There is an article in the Consumer Reports issue that is out now
> which talks about the obesity problem, and one of the factors in
> obesity is portion size, and one of the things we have learned about
> portion size is that people take home from restaurants a subjective
> impression of what is an appropriate portion size.
>
> So, people are now serving much larger servings of meals at home
> because they get them in restaurants, and people are eating more,
> consuming more calories than was true a decade ago.
>
> I think the last point I want to make is about the message, and I
> think this is the area
>
> where the advisory needs the most work. I found it very confusing, I
> found it scientifically incorrect, and I found it, in many cases,
> self-contradictory.
>
> I think the message is it follows in an FDA tradition of what I call
> the warning label approach, which is if something is dangerous, you
> want to tell people not to eat it. That leads to a false dichotomy.
>
> If it is not dangerous enough to require a warning label, it must be
> safe, and that is not the case. Risk is a continuum and to single out
> four very high mercury fish and then say in several ways, and
> everything else is okay if you moderate your intake, I think is
> misleading and wrong.
>
> We have also learned at Consumers Union that what people want more
> than anything else is tell me what to buy, what should I be eating.
> Telling me what not to buy is one part of the information, but what
> people want most is to know what to buy.
>
> If you look at Table 2 in the handout, and
>
> if you modify that, which I have done, but haven\'t done in that one,
> by including the updated FDA data that were released for this meeting,
> there are now about 15 varieties of fish and seafood, including a
> large number that are very widely consumed, like shrimp, scallops, and
> salmon, that are below 0.12 parts per million, which is the level of
> mercury at which, if you consume 12 ounces a week, you will just meet
> the RfD.
>
> So, there are 15 low mercury choices, and if I were to rewrite this
> advisory at this point, and, like Caroline, I think I could do it
> pretty quickly, I would say, first, choose from this list of fish to
> keep your mercury within safe limits, and basically, you could say eat
> as much as you would like of these fish and you will be safe. That
> would be those with less than 0.12.
>
> Then, I would say do not eat the four with the highest mercury, put
> the warning label in there, and with respect to everything else, I
> would say don\'t eat more than one portion a week. Eat a variety, but
> don\'t eat more than one portion a week
>
> of any of those others because many of them are moderately high in
> mercury.
>
> The one point I might modify in what I just said is FDA, in the
> Carrington and Bolger paper, has defined high and low and moderate
> mercury content. High is above 0.5. I might add to the Do Not Eat list
> those fish that have above 0.5. There would be three or four other
> things to add to the four that are already on that list.
>
> I think also in terms of specific advice about tuna, it needs to be
> much clearer that albacore tuna and fresh tuna steaks are in the
> moderate, don\'t eat more than once a week, and eat only small
> portions of category.
>
> I think light tuna fits into the low mercury category especially with
> the decimal point refined with the latest data it would be around
> 0.12, and that is fine, but you need to be much more specific and give
> clear advice about not eating too much albacore or fresh tuna steaks.
>
> I think that is it, and I would be happy to answer any questions.
>
> Thank you.
>
> DR. MILLER: Thank you, Ned.
>
> Any questions or comments? Thank you.
>
> The next speaker is Michael Bender, Director of Mercury Policy
> Project. Eight minutes.
>
> MR. BENDER: My name is Michael Bender. I am the Director of the
> Mercury Policy Project. We are a nonprofit, focused on reducing
> mercury emissions and exposure to mercury at the local, national, and
> global level.
>
> We have no financial relationship with the sponsors. I appreciate the
> opportunity to be here. Like others, I just wanted to express my
> appreciation for FDA and EPA getting together and trying to put
> together a comprehensive advisory.
>
> It is also good to see that FDA has gone out and done some canned tuna
> testing, some comprehensive testing for the first time in 10 years,
> and that sort of came on the heels of our testing of 60 cans of tuna
> in June of this year, and we are also glad to hear that they are
> planning on doing additional testing.
>
> While this is difficult for people to read, and I apologize for this,
> everyone should have a copy of this in front of them, at least the
> committee members, and I decided to take a more pragmatic approach
> than my colleagues, and while I would second the recommendations to
> work with the stakeholders and to see if we can come together and to
> make some kind of a comprehensive approach that addresses the issues
> pragmatically, I wanted to make some suggested changes if you are
> presumably working off from this draft and trying to improve it.
>
> The first thing I would suggest would be simplification, offer more
> specific consumption advice for children would be secondly. An
> approach to the use by the State of Washington, and I will show you a
> graph exactly what they do, and also, as other speakers have
> suggested, make your recommendation more consistent with the EPA\'s
> reference dose while promoting consumption of low mercury fish and
> shellfish.
>
> I would reword the title, Advice for women
>
> who are pregnant, might become pregnant, nursing mothers, and young
> children, about reducing mercury exposure from fish and shellfish
> consumption. Straightforward and to the point.
>
> I don\'t have a problem with starting out with saying that fish is an
> important part of a balanced diet. I think it is important to continue
> to convey that message, but the first change would be the suggestion
> to eat low mercury fish and shellfish, I don\'t think this can be
> emphasized enough. That would be in the second clause of the handouts.
>
> The second change would be, suggestion would be to add albacore tuna,
> and that would be both fresh and canned tuna, based on not only the
> FDA\'s data, but also our data, and other data from Consumers Union,
> the FDA data from 1992, et cetera.
>
> That third change would be in No. 2, where there is a recommendation
> for 12 ounces a week. I would recommend that in lieu of any kind of
> list, that you change that to 6 ounces (one meal) per week of
> purchased fish and shellfish.
>
> I would also, in my next suggested change, move from the Q and A,
> where we are for the first time ever addressing tuna in a question and
> answer, and I would argue that a lot of people won\'t get that far,
> that you need to have a sentence in No. 2 which, in a positive way,
> states that you can consume light canned tuna in moderate amounts or
> in moderation as part of your weekly consumption.
>
> My next suggested change, and mentioned by Dr. Wallinga, was in the
> EPA part of the advisory where they talk about local streams and
> rivers at lakes and ponds. Most of the fish probably comes from lakes.
>
> I guess for the children-specific section of the advisory, give
> examples. For example, a
>
> 20-pound toddler can eat 1 ounce of fish or shellfish per week, a
> 40-pound can eat 2 ounces of fish or shellfish per week, and an
> 80-pound child can eat 4 ounces of fish or shellfish per week.
>
> I just will quickly go through\--I just have two or three slides. This
> has been mentioned before. There are now 11 states that warn pregnant
>
> women and, in some cases, young children, to limit consumption of
> canned tuna. These warnings started in 1997. Actually, there is
> another one, Hawaii is now added to the list.
>
> Not only do they talk about limitations, but they also note starting
> in 2000 in Maine, that women of childbearing age limit to one can of
> white or two cans of white. There is a distinction that is being made.
> Again, that was based on the FDA dataset from 1992, a very robust
> dataset.
>
> This is from the Washington State Health Department. It\'s right on
> their website. It basically talks about, it follows the EPA reference
> dose of body weight per kilogram per day, or I think it might be a
> little more stringent. The note I have here is that it is based on the
> FDA lumpage of 0.17 ppm, and not the new FDA data, the average mean of
> 0.358.
>
> Just looking at the person\'s body weight at the bottom, that is where
> I derived the recommendation for the children. As you can see, for a
> 20-pound child, this would be less than 2
>
> ounces; for an 80-pound child, it would be 4 ounces.
>
> So, I think there is some information out there that is available on
> this.
>
> Secondly, I just wanted to bring your attention to our canned tuna
> dataset. As I mentioned earlier, we released our results in June, and
> the average we found was about 0.5 ppm, a little bit higher than the
> FDA dataset.
>
> The range was greater. It was from 0.23 to 1.1 ppm. I believe the last
> time this committee met, Dr. Aposhian had mentioned that he had tested
> 10 cans of tuna and found 1 over 1 part per million. The industry has
> also indicated that some of the canned tuna comes in over 1 part per
> million.
>
> \[Inaudible comment.\]
>
> MR. BENDER: I am sorry. Yes, the bottom is the light tuna and what we
> found\--I am glad you mentioned that\--the average for the 10 cans was
> 0.118, which is very consistent with the FDA\'s testing both this year
> and in their 1992 test.
>
> It is difficult to read this one, as well, but basically, we just did
> some calculations if we were to apply the FDA\'s mean of 0.358 to the
> different body weight.
>
> For instance, a 22-pound toddler eating only 2 ounces of tuna per week
> with the 0.358 ppm would exceed the EPA\'s RfD nearly 3 times; a
> 44-pound child consuming 1, 6-ounce can of tuna with 0.358 would
> exceed the RfD by over 4 times; an
>
> 88-pound child consuming 1, 6-ounce can of tuna with a 0.358 ppm would
> exceed the RfD by over 2 times.
>
> A woman with a typical body weight of 132 pounds consuming 2 cans of
> tuna per week with 0.358 will exceed the EPA\'s RfD by almost 3 times.
> Also, if the same woman eats only 1, 6-ounce can with the same ppm,
> she will exceed the EPA\'s RfD by over
>
> 1 1/2 times.
>
> DR. MILLER: Could you summarize.
>
> MR. BENDER: Yes. So, in summary, I guess I would just reiterate many
> of the points of my colleagues, and if the committee was at a place
>
> where they wanted to move forward now rather than suggest revisions
> for the future, I would suggest that they consider some of the points
> not only that I made, but of my colleagues.
>
> Thank you.
>
> DR. MILLER: Thank you.
>
> Questions or comments? Thank you.
>
> The next speaker for 5 minutes is Dr. Joanna Burger of Rutgers
> University.
>
> DR. BOEHM: My name is actually Dr. Susan Boehm from the New York
> Academy of Sciences. I am speaking on behalf of Dr. Burger who could
> not be here for part of my remarks, and then I will speak for myself,
> as well.
>
> Dr. Burger has no financial ties to either of the funders here.
>
> I am talking specifically today about a paper that is in publication
> by Drs. Burger from Rutgers University and Dr. Gochfeld from the
> Robert Wood Johnson Medical School, where they looked at approximately
> 145 cans of tuna, white and light. I will present the highlights of
> that.
>
> There are about 12 copies of this paper. It has been embargoed until
> publication, but she got permission to distribute it to the committee,
> and some of those have been distributed. Then, there is a summary page
> that is out on the table that summarizes the findings.
>
> Of the 123 cans of albacore and 45 cans of chunk light tuna, they
> demonstrated there was a much higher mercury concentration in the
> albacore tuna, on the order of 3 1/2 times. This is very similar to
> what has been seen before.
>
> They also did these analyses over a number of years, and there is
> evidence that there could be increases, that we could be increasing
> mercury concentrations over time in cans of tuna.
>
> Also, there have been some spike years probably due to changes in
> fishing.
>
> Approximately, 90 percent of the mercury that is in the tuna is in the
> form of methylmercury. That is important to always keep in mind.
> Twenty-five percent of the albacore tuna that they tested was over the
> 0.5 ppm level.
>
> They recommend that persons who are frequently eating canned tuna
> could, in fact, choose light tuna over the white tuna if they were
> aware of these differences, and that systematic monitoring of the cans
> of tuna supplies should be established, that doing it once every 10
> years is clearly not enough if we are, in fact, seeing increasing
> levels of over time, and that fish advisories should always
> distinguish between the two types of canned tuna.
>
> They also measured about 9 cans of mackerel, canned mackerel, and
> found them to have low mercury concentrations, so that might be
> something that could be put as a positive thing, something that could
> be eaten.
>
> That is the summary of Dr. Burger\'s comment.
>
> I am now going to speak for myself from the New York Academy of
> Sciences, and I will disclose that we do have\--I work on a project, a
> large-scale, ongoing project, multi-funded, but one of our funders is
> EPA.
>
> Our work, what we do is we track sources of mercury and methylmercury
> to the New York/New Jersey harbor, so we backtrack to every product
> process that releases or produces or uses mercury, trace how it is
> used, released, and produced through disposal, and look what is
> getting into the harbor, but the idea of figuring out ways to step in
> and keep mercury out of the harbor. That is the background of our
> work.
>
> I wanted to sort of echo something that Dr. Dwyer pointed out, that
> this wording in the newest advisory really focuses, while it is very
> important to focus on women and children, the rest of the population
> has now been left out, that the rest of the population is not included
> or is not specifically included now in this document.
>
> It is the responsibility of the FDA to provide the information to the
> consuming public, and it is very important that we target children and
> pregnant women about safe consumption habits and about light versus
> dark tuna, but also cover all populations.
>
> Fish are well established as being a healthy source of protein. The
> FDA has an opportunity to give people positive choices for fish
> consumption, not just what should not be eaten.
>
> From our work, I think really crucial is implementation, is how this
> is going to be implemented. The old approach of handouts and things
> like that or fish advisories on the web is not going to work. We know
> this from our own work as we try to implement some of our
> recommendations, you really have to target specific populations.
>
> We know in the New York area, we have a lot of subsistence fishermen.
> We have recently learned that women in the WIC program, women with
> infant children are subsidizing their food by fishing in the East
> River, and this is a population that has been completely ignored.
>
> Finally, I just wanted to mention in the advisory, in the statement on
> what is mercury, it notes mercury \"occurs naturally in the
> environment and can also be released into the air.\"
>
> Mercury is released into the air from industrial pollution. We don\'t
> need the word \"can\" there at all.
>
> Also, in the New York/New Jersey region, the major source of mercury
> is not necessarily from the air to the harbor, it is through the
> wastewater treatment facilities and generally from dentists,
> hospitals, and laboratories. So, that statement isn\'t quite complete
> for the national picture.
>
> That\'s it. Thank you.
>
> DR. MILLER: Thank you.
>
> Questions? Johanna.
>
> DR. DWYER: Just a quick one. On the values that you were talking
> about, the samples that were analyzed, I was intrigued by Dr. Lund\'s
> suggestion yesterday that there was a way to try to find out
> geographically where high samples might come from, and wondered if you
> had done that, of if that group, or anybody else had done that.
>
> DR. BOEHM: They have made note of where the cans of tuna indicated
> they were from, the countries, but that doesn\'t necessarily mean they
>
> were caught near that country, because the fish can be moved to areas
> where it is easy to process, so there is not, in this report, they had
> no way to track where the fish were coming from.
>
> DR. ALLER: Just a quick question, I just want to make sure I
> understood. For the second half of your remarks, were you speaking for
> yourself or for the National Academy?
>
> DR. BOEHM: New York Academy of Sciences.
>
> DR. ALLER: Thank you.
>
> DR. ACHOLONU: You mention that mercury comes from dentists. Is that
> significant enough to be mentioned in the advisory?
>
> DR. BOEHM: The mercury that you are seeing in fish, there is no way to
> tell where it is coming from, and in different places, it is going to
> have different sources. It is sort of a very separate issue from what
> is being discussed here, I would say.
>
> DR. MILLER: The difference is, is the amalgam. It is direct exposure.
> Since our concern is entirely on what appears in the fish\--
>
> DR. BOEHM: We are talking about mercury that goes through a dental
> facility into the wastewater treatment facility and gets into the New
> York/New Jersey harbor, not the direct human, in your mouth, it is
> human contact. We are talking about what ends up in the harbor.
>
> DR. MILLER: Right, and that is the source of mercury that contaminate
> fish would probably be relatively small.
>
> DR. BOEHM: In fact, it is not because wastewater treatment facilities
> are great methylators. They have all the right conditions for
> methylating mercury, so it turns out to be a source of methylmercury
> to the harbor.
>
> DR. MILLER: Thank you.
>
> The next speaker is Jane Houlihan, Environmental Working Group.
>
> MS. HOULIHAN: Good morning. I am Jane Houlihan, Vice President for
> Research, Environmental Working Group. We are a public health research
> organization based in Washington, D.C.
>
> Just a point of clarification, Dr. Miller, I requested and was told I
> was granted 15 minutes. Is that what you understand?
>
> DR. MILLER: That\'s right.
>
> MS. HOULIHAN: I just want to cover two things briefly today. The
> first, is this advice protective? We think it\'s not and I will lay
> out some detailed calculations on why that is. I also want to talk
> about the adequacy of some of the fish testing data that underlies the
> exposure and risk models and that really forms a backbone of the
> consumer advisory.
>
> For many, many species, adequate testing has not been done, and it
> gives this advisory a pretty weak scientific background for a lot of
> the popular fish that are consumed in the U.S.
>
> First of all, I did just want to say congratulations to EPA and FDA.
> It\'s a big step forward to work together on this advisory and get
> together on one page. I also wanted to thank FDA for responding very
> rapidly in expediting a Freedom of Information Act request we
> submitted for the new
>
> testing data, so thank you for that.
>
> As you all know by now, there are three key parts to FDA\'s
> consumption advice: Don\'t eat shark, swordfish, king mackerel, or
> tilefish.
>
> It is safe to eat up to 12 ounces of seafood each week except for
> these.
>
> Do not eat the same type of seafood more than once a week.
>
> Then, the advisory tells the target population that following this
> advice is safe and protective.
>
> So, I want to go into why it is that that advice is not safe and not
> protective to follow in a lot of instances. The case study I want to
> use is canned tuna, but I will also point out that a number of fish
> that have even higher levels than canned albacore tuna later in the
> presentation.
>
> First of all, this graph represents FDA\'s understanding of mercury
> levels in canned tuna as it has evolved through time. That second bar
> represents the average level of 0.17 ppm of mercury in canned tuna as
> FDA understood it when the 2001
>
> advisory was issued. At that point, the agency had very little
> information to differentiate between kinds of tuna.
>
> There was a 1993 study done by FDA. That is represented by the third
> bar. In that study, 19 samples of albacore tuna were tested and were
> found to have significantly higher levels of mercury than the bulk of
> the tuna samples FDA had in hand.
>
> Well, now this new testing program from 2003 really gives FDA a lot
> more ability to differentiate between tuna types. So, now we see the
> first and fourth bars on that graph represents what is known now as
> the difference between light tuna and albacore tuna.
>
> There are substantial numbers of samples and probably represent a
> fairly good estimate of what is really going on - 170 samples of
> albacore, even more samples than that of light tuna.
>
> So, we see right off the bat, first of all, albacore tuna has twice
> the levels that FDA believed were generally in tuna for the 2001
> advisory. Albacore tuna has 3 times the levels
>
> that are found in light tuna.
>
> So, out of this new understanding of mercury and out of the
> committee\'s recommendations last year, that FDA really needs to tell
> women what is going on with canned tuna, we get this advice. Mercury
> levels in tuna vary. Tuna steaks and canned albacore tuna generally
> contain higher levels of mercury than canned light tuna, and we also
> get this sentence after this, you can safely include tuna as part of
> your weekly fish consumption.
>
> So, a read of this advice and FDA\'s own statement that this
> implicitly means 4 to 6 ounces of tuna can be safely consumed each
> week gives us a safe scenario under this advice of eating 6 ounces of
> canned albacore each week, and that is the scenario I would like to
> look at in detail here.
>
> We find that the simple calculation outlined here that by eating 6
> ounces of canned albacore tuna each week, a woman of average size
> would exceed a safe dose by about 30 percent. For instance, a woman
> who weighs 140 pounds, a weekly
>
> serving size of 6 ounces, which is 170 grams, translates into a daily
> serving size of 24 grams, so we are thinking about average mercury
> exposures here and averaging them through time. Mercury concentration
> in canned albacore tuna based on FDA\'s new testing program is 0.36
> ppm.
>
> So, the amount of mercury this woman would ingest each day, of course,
> is her daily serving size times the mercury concentration, and that
> equates to 8.6 micrograms of mercury each day.
>
> The body weight adjusted dose then, we just divide that number by her
> weight, 64 kilograms. Her long term steady state dose from this
> consumption pattern is 0.13 micrograms of mercury per kilogram of body
> weight per day.
>
> We compare that against EPA\'s reference dose of 0.1 and find that it
> is substantially higher than a supposed safe level of exposure.
>
> So, the conclusion that we find from this is that women who follow
> FDA\'s advice could face a significant risk of being exposed to
> mercury at levels above a safe dose.
>
> You know one of the arguments that has been made is that women don\'t
> really eat this much tuna, so we don\'t need to explicitly say in the
> advisory please don\'t eat this much tuna. I just want to point out
> some women from FDA\'s focus groups conducted in 2000 who said that
> they do eat this much tuna.
>
> I haven\'t looked at the transcripts from the recent focus groups, but
> the 2000 focus groups, FDA tested their messages on approximately 100
> consumers maybe, and, of that, 5, I had pulled out 5 women from these
> groups. This woman ate tuna every day, 5 days a week for lunch for 7
> weeks.
>
> This woman ate more than a can and a half a week. She is referring to
> her long-term consumption in this sentence.
>
> Another woman ate tuna every day for lunch because it was convenient.
> Another woman says she just bought a whole bunch of it because it was
> on sale for 39 or 49 cents a can.
>
> Even another woman says she ate during the summer as part of being on
> the Adkins diet, a can
>
> of tuna, a hard-boiled egg. That was her lunch, and she was on this
> diet in preparation for being pregnant.
>
> Another woman just sums it up as \"It is real cheap,\" and that\'s why
> women eat it, it is very convenient and cheap.
>
> Now, albacore canned tuna is more expensive than light, but it is
> still relative inexpensive as a protein source for pregnant women.
>
> We went one step further and looked at the distribution of women in
> the population and how much they weigh, and really a more detailed
> look at the risk faced by women who would eat 6 ounces of canned
> albacore tuna a week.
>
> We conducted a Monte Carlo style model. This is simply a model that
> creates virtual women by picking measured body weights from CDC\'s
> NHANES population and pairing those with mercury concentrations from
> FDA\'s most recent albacore sampling program conducted this year.
>
> So, we used body weights, measured body weights for 1,767 women. We
> used mercury
>
> concentrations in canned albacore tuna from 170 samples, and we
> modeled a period of 40 weeks to simulate a typical length of
> pregnancy. We are just working with steady state concentrations here,
> we are not thinking about spikes or shorter term exposures.
>
> The result of this model was that by eating a 6-ounce serving of
> albacore tuna weekly, we found that 74 percent of all women would
> exceed a safe dose of mercury for the duration of their pregnancy on
> average.
>
> The detailed calculation results are shown here. The red line, the Y
> axis is, of course, the dose of mercury, the average dose a woman is
> exposed to over pregnancy in this model. The X axis is the percent of
> women who exceed that dose, and that red line represents the current
> reference dose from the Environmental Protection Agency.
>
> So, you can see where the blue and red lines cross is really what we
> care about, and we show that that percent of women exceed, 74 percent
> of women exceed that dose.
>
> This point has been made in other ways, but I would just like to say
> the point of this slide is to show that what FDA is doing in
> translating a risk model into individual advice for consumers is
> inappropriate.
>
> FDA\'s simulations show that by chopping off, by forcing high-end
> seafood eaters to eat less seafood, they can ramp down populationwide
> risks from about 8 percent to 1 percent of over exceedences, but it
> does not, therefore, then translate that it is safe to eat up to that
> amount for an individual. In fact, in FDA\'s models, probably the
> women who tend to exceed the reference dose are those who are eating
> 12 ounces of fish a week, and by telling an individual that is a safe
> thing to do, you are actually advising them to do a fairly risky
> thing.
>
> So, the model has really been used in an inappropriate way in
> developing advice for individual consumers.
>
> I want to use this slide to point out two things. The data here
> represent the new data that
>
> FDA collected this year in their testing program. Tilefish in this
> testing program showed an average concentration of 0.2 ppm. These fish
> are on the list of fish not to eat.
>
> Now, these tests are substantially lower than tests that FDA based the
> initial advisory on, but one of the interesting things in the new data
> is that 5 other kinds of fish exceed the level that are in tilefish, I
> think gold-faced tilefish that were tested. Bluefish, sea trout,
> canned tuna, orange roughy, and grouper.
>
> Now, the question is tilefish levels are certainly not well
> understood. Levels were much higher in the earlier sampling tests than
> they are shown here. It is not even clear what tilefish are. I think
> people are very confused about that. The data we were sent from FDA
> calls the fish \"golden tilefish,\" which I don\'t find in my
> guidebooks or in FDA\'s regulatory market dictionary.
>
> There is something called gold-faced tilefish, it might be that, there
> is also a Pacific
>
> tilefish that is commonly referred to as \"ocean whitefish,\" so it is
> not at all clear what tilefish are, and I think this is a concern
> because it is one of the four fish explicitly mentioned in the
> advisory, and I don\'t think the agency even has a real understanding
> of what it is.
>
> It is an example of sort of the weak scientific underpinnings of many
> points in this advisory.
>
> The second thing I want to point out is that the new data show that
> there are fish that have even higher levels of mercury than canned
> albacore tuna. We have shown that it is not safe to regularly consume
> canned albacore tuna. It would also not be safe to consume orange
> roughly or grouper if these samples are representative of what is
> really going on in these species.
>
> We also find that tuna steaks and American lobster according to FDA\'s
> testing data have similarly high levels.
>
> This is a quick comparison of data used by FDA to develop their 2001
> seafood consumption
>
> advisory shown in the lighter bars, and then the darker bars represent
> what their new data shows.
>
> I just want to point out that in a couple of key instances, the new
> data, even though the sample sizes are very small, increase the
> agency\'s understanding of what is going on with that fish
> dramatically. In these cases, it seems that the mean levels for this
> fish group or sea trout and bluefish are substantially higher than
> what the agency previously believed.
>
> This is a concern for a couple of reasons. The sample sizes FDA is
> working with are so small that even 20 samples can significantly alter
> the agency\'s understanding of concentrations in fish. We don\'t see
> the kind of statistically valid sample sizes we need really to have a
> solid scientific underpinning for an important public health advisory
> like this.
>
> This is another instance where I am just showing you the sample sizes
> FDA is working with in this risk model in the development of this
> public health advisory.
>
> On the lefthand side of this chart are the sample sizes FDA is working
> with for the top 10 seafood in the U.S. - canned tuna, crabs,
> pollocks, salmon, catfish, shrimp, cod, flatfish, tilapia,
>
> and clams. This is ordered by sample size.
>
> There are only 3 kinds of fish in the top 10 seafood for which FDA has
> more than 100 samples. For 6 of these, FDA is working with fewer than
> 30 samples.
>
> I just compare that briefly to an assessment FDA recently did on
> children\'s exposure to organophosphate pesticides. This is just a
> tiny fraction of their sampling program. I pulled out some fruits and
> vegetables they test as part of the underpinning to their assessment
> of just one organophosphate pesticide of the many analyzed
> dimethoates. They sampled a minimum of hundreds of samples for each of
> the fruits and vegetables that were included in the assessment.
>
> They sampled over 2,000 carrots, they sampled almost 2,500 apples,
> over 1,000 bananas to provide them the kind of scientific underpinning
>
> that they needed for this public health advisory, and the risks are of
> similar magnitude to what we are talking about here, if not greater
> magnitude here than EPA\'s analysis.
>
> So, I just want to point out briefly, just pull out 3 of the fish in
> the top 10 to show you really the kinds of complexities we are working
> with and the kinds of sample sizes that are really needed to
> understand what is going on here.
>
> FDA has tested 25 samples of shrimp. Shrimp is the number one seafood
> in the U.S. The National Marine Fisheries Service data shows it is
> caught commercially in 20 states, it is imported from 21 countries, it
> is farmed, it is caught in the wild.
>
> We eat such a diverse source of shrimp and we only have 25 samples,
> and for the top seafood in the U.S., this does not seem like a solid
> scientific basis for moving forward with an advisory that includes
> advice on shrimp.
>
> FDA has tested 6 clams. Claims is the No. 6 seafood in the U.S. The
> National Marine
>
> Fisheries Service says it\'s landed in 9 states, we import from 30
> countries. Six samples of clams is not enough to move forward with a
> public health advisory on clams.
>
> FDA has tested 8 tilapia, the No. 9 seafood in the U.S. It is landed
> commercially in 2 states, we import from 27 countries. Clearly another
> case where the sample size is insufficient for FDA to understand what
> the mercury distribution might be in that particular fish, and
> clearly, the sample size is not sufficient to move forward on that
> fish with a public health advisory that includes advice for women to
> consume that fish.
>
> DR. MILLER: Would you summarize, please.
>
> MS. HOULIHAN: Yes. I am on the last slide.
>
> Our recommendations are, first of all, obviously, FDA should test
> fish. They need to adequately characterize the distribution of mercury
> levels in the U.S. seafood supply. They can\'t get there by testing 20
> fish a year for a fraction of the species we eat.
>
> This has got to be a big comprehensive sampling program that has some
> statistical backing, and I hope the committee can recommend that FDA
> do this because I think it would help them shake loose some funding to
> get that done, which would require substantial funding.
>
> FDA should issue an advisory that tells women what fish are safe to
> eat in quantities that meet omega-3 requirements. Two of three peer
> reviewers told FDA specifically please consider omega-3\'s when you
> are developing this advisory. We think it is really important, women
> need to be able to consume fish safely to meet their omega-3
> requirements. It is very important for proper fetal brain development.
>
> One of the key things FDA can do in that department is provide
> consumers with a list of safe fish. FDA should also add canned
> albacore tuna, as well as the other species I mentioned with high
> levels, to the list of fish women of childbearing age and children
> should not eat.
>
> Any questions?
>
> DR. MILLER: Yes.
>
> DR. ACHOLONU: A few speakers have made the observation that some of
> the common names varied depending on where you are.
>
> Do you think it would be advisable for the FDA to include the
> scientific name of the fish, put that in parentheses in the advisory
> to be distributed to the public?
>
> MS. HOULIHAN: I think that is absolutely critical, and I think FDA has
> got to figure out what is going on in the various states, so that
> people get the right advice in the right state.
>
> I mean you brought up the example of cod, and I will pull that out,
> because cod, 71 percent of our cod we eat is domestically caught,
> Pacific cod from Alaska, 12 percent is imported Atlantic cod, 17
> percent is imported other cod. FDA has 20 samples of cod, most of it
> is domestic. They have 2 samples just called \"cod,\" one sample of
> black cod that I actually think is from a completely different family
> of fish.
>
> So, it is so complex and will vary so
>
> much, and it is such important advice to get out to people that it is
> really going to require that FDA and EPA figure this out.
>
> DR. MILLER: Yes.
>
> DR. NELSON: Considering your statement that you want the advisory to
> be science based, and the data you provided about the analysis for
>
> tilapia and shrimp, are you suggesting that FDA
>
> consider those guilty until proven innocent, or disregard those
> species, or what?
>
> MS. HOULIHAN: I think because of the import to public health, if I
> were in charge of FDA, I think what I would do is move forward with
> advice on fish for which they have statistically significant numbers
> of samples, and that includes canned tuna. So, I feel like they are in
> a good position now to include albacore canned tuna on the list.
>
> I would also advocate for providing a list based on the agency\'s
> current understanding of what low mercury fish are, so women know what
> is safe to eat, and then, at the same time, move forward very
>
> aggressively on testing fish in adequate levels, so they really get a
> much more in-depth understanding of the distribution.
>
> DR. NELSON: I also wanted to comment on the emphasis on a safe level,
> or, in quotes, on a \"safe\" level in reference to the RfD, and
> wanting sound science and something definitive.
>
> I don\'t believe the RfD is quite that solid in that sense, not the
> calculation, but the concept of the safety, and I am not convinced
> that somebody consuming 0.13 as opposed to 0.1 is a significant
> increase or decrease in safety, if you will.
>
> MS. HOULIHAN: Right.
>
> DR. NELSON: I think the RfD is based on consumption over a lifetime,
> and I think that is why, in earlier drafts of the advisory, we saw a
> statement like if occasionally you consume more, it is not the end of
> the world, but clearly, the advice needs to be there to moderate the
> consumption.
>
> MS. HOULIHAN: And I think it is also
>
> important to remember that the reference dose is consistent with NAS
> recommended benchmark dose which is derived from fetal cord blood
> levels, and the NAS said that those are best thought as corresponding
> to probably a trimester of pregnancy.
>
> So, in that instance, FDA\'s assessment is not conservative, but they
> are considering steady state dose over an entire pregnancy, they are
> not considering excursions above the RfD for a trimester or shorter
> periods during pregnancy.
>
> DR. DWYER: It seems to me two things are becoming clear from what you
> have said. One is just the notion of modeling, I don\'t think you are
> disagreeing with. You are just saying you think you have a better
> model, right?
>
> MS. HOULIHAN: I think that the data that underlies this model is
> extraordinarily weak.
>
> DR. DWYER: It seems to me one of the pieces of data that is weak, that
> you didn\'t mention as much, that I thought I heard Dr. Acheson say
> that they were trying to remedy is the issue of exposures.
>
> In other words, and it is complicated by what Dr. Alex just said about
> the names, in other words, for things that are not very commonly
> eaten, not perhaps tunafish, but some of these other fish, you really
> have to do better than what we are doing right now in national survey
> data.
>
> It seems to me it is very important in our recommendations for the
> future that we include better estimates of recalls than we get right
> now. I think there is some work being done now on a propensity sort of
> questionnaire to add to the data that we could get from NHANES, and I
> hope that is done.
>
> The second point is exposure depends on knowing what people are
> eating, and the other thing it depends on, as you pointed out, were
> food composition values, and in this case, this contaminant. I think
> it is very important, as you do I guess, to get as many representative
> data as we can on the mercury levels in these various kinds of
> seafood.
>
> Again, I wonder if the only way to get
>
> them is having FDA go out and do a huge survey. It probably doesn\'t
> come as news to you, but there are many values for many nutrients that
> are not much better than the values we are talking about here. We
> don\'t have a lot of food composition data even sometimes on essential
> nutrients.
>
> So, again, I go back. Are there any other sources other than going out
> and doing food surveys where we could get more data, perhaps industry,
> perhaps states have data, that are collected in a uniform fashion
> using appropriate standards for judging how much mercury there is,
> just to get on with this instead of going into the fourth millennium
> still arguing.
>
> DR. MILLER: Dr. Russell.
>
> DR. RUSSELL: I wonder, are you suggesting that FDA and EPA do a
> continual survey of fish, kind of ongoing, with the idea that maybe
> levels are rising in certain fish species?
>
> MS. HOULIHAN: It may be that levels are changing in certain species.
> There aren\'t the data to say that definitively. But it makes a lot of
>
> sense particularly for fish that live near the coast where land-based
> pollution may be much more of an issue.
>
> What I would like to see is a big comprehensive testing program, one
> big bang program to try to get a really good grasp of this problem,
> get a great consumer advisory developed out of that, and then a
> smaller program of ongoing testing that would try to get at some of
> the issues of trend or levels going up with time.
>
> DR. MILLER: But are you saying that FDA and EPA should delay issuing
> their advisory?
>
> MS. HOULIHAN: I don\'t think we lose much by not issuing this current
> draft advisory because it doesn\'t really represent any more
> substantive information for consumers than the previous advisory.
>
> What I do advocate for the agency going forward with at this point is
> getting information to people much more specifically on canned tuna,
> an explicit warning, and explicitly telling pregnant women to not eat
> canned albacore tuna, and I would
>
> also just advocate that FDA move forward with getting a list of fish
> to women that are believed to be low in mercury at this point.
>
> DR. RUSSELL: Just one other thing I have been thinking about. If you
> come out with a list of fish that you say are safe based on mercury,
> are you concerned that down the road, that some of those fish on the
> safe list will be contaminated with PCBs or something else, and then
> the message has become just so very confusing about what you are
> telling people to do?
>
> MS. HOULIHAN: Right, and if not more, it\'s a three-pronged problem
> because omega-3\'s are so critical, it is our most important source of
> omega-3\'s, and mercury and PCBs are both big pollution issues in
> fish.
>
> So, for instance, if FDA moved forward with recommending that people
> eat farm salmon, that is probably not safe from the perspective of
> PCBs. So, I have advocated for a long time that the agency take a more
> holistic look at seafood.
>
> DR. MILLER: We are going to move on. We
>
> have several speakers still and it is only fair they have their
> chance.
>
> Thank you.
>
> The next speaker is Dr. Rick Jarman from the National Food Processors
> Association.
>
> MS. APPLEBAUM: I am also from the National Food Processors
> Association, but I am Rona Applebaum instead of Rick Jarman.
>
> Good morning. I do work for the National Food Processors Association.
> I work as their Executive Vice President and Chief Science Officer.
> NFPA is the principal scientific and technical trade association for
> the food industry. We represent over 400 processing and supplier
> companies.
>
> Our focus is public policy and science issues involving food safety,
> food security, nutrition, technical and regulatory matters, and
> consumer affairs, and NFPA has no financial relationships with either
> of the sponsors.
>
> We very much appreciate this opportunity to share our comments on
> FDA\'s and EPA\'s activities
>
> regarding the revisions to the agency\'s consumer advisory on
> methylmercury and fish consumption. We are strong advocates for the
> use of sound science as the basis for any and all dietary advice given
> to consumers.
>
> We believe the FDA is to be commended for addressing the
> recommendations given to them by the Food Advisory Committee and
> moving forward in a timely manner to develop and test the revised
> consumer advisory.
>
> My comments this afternoon will focus on the consumer advisory,
> consumer testing, as well as the need for more research. Advice to
> consumers on fish consumption is very complex. Advice to consumers in
> general is very complex. It is critical that any action taken in
> regards to consumer advisories assess the potential adverse impacts
> that may result due to the reaction on the part of the public to such
> advice.
>
> The potential impact of advisories, including those designed to
> improve public health, must consider the full range of implications
> that
>
> may result to ensure the initial good intent of the advisory follows
> through to positive outcomes. More on this in a few moments.
>
> Thus far, we believe FDA is meeting the challenges of integrating
> information from a variety of sources on the numerous factors that
> must be considered in providing sound actionable advice to the public
> on safely consuming fish which has repeatedly been recognized as
> contributing to a healthful diet.
>
> It is clear that FDA is considering all of the key issues including
> quantities consumed and the benefits of fish consumption in order to
> provide consumers with the facts and the necessary advice on
> methylmercury and fish consumption.
>
> NFPA has actively followed FDA\'s process of reviewing the consumer
> advisory. We believe that gaining insight directly from consumers is
> essential.
>
> For any consumer advisory to be effective, they must be both
> understood and correctly interpreted by consumers. Messages are
> important,
>
> but it is critical that their ultimate result be a positive behavioral
> change.
>
> To this end, message testing is an absolute necessity, and such
> testing appropriately has been an integral part of FDA\'s activities
> in reviewing its consumer advisory.
>
> Throughout the process of reviewing and revising this consumer
> advisory, FDA has acknowledged the difficulty of wording an advisory,
> so that it provides appropriate guidance to the populations at risk to
> help these populations decrease their methylmercury exposure while not
> discouraging consumers, or worse yet, steering consumers away from
> diets containing fish and other seafood.
>
> Let\'s not forget the majority of food purchases are done by female
> heads of households. What they choose to bring into their homes is not
> only their dietary regimen, but also the dietary regimen of their
> family.
>
> To this end, based on our observations from the FDA focus group
> sessions, we strongly
>
> believe that further consumer testing is necessary to ensure that any
> revisions to this consumer advisory are effective in better informing
> consumers.
>
> What we must avoid at all costs is the unintended effect\--and it has
> been discussed
>
> today\--of the advisory being read, understood, and interpreted as a
> warning against consuming all fish. Warnings, by nature, and its
> consumer research supports, can be translated into complete avoidance
> behaviors especially if alternatives exist.
>
> The concern here is that alternatives that might be selected\--and I
> am not referring to fish alternatives, I am referring to non-fish
> alternatives\--will not be identical substitutes necessarily.
>
> In this instance, the concern that bears mentioning is the avoidance
> again of all fish with substitutes that do not provide the equivalent
> nutritional benefits of fish.
>
> This is a major concern and is
>
> contradictory to the advice given by many public health professionals,
> public health societies, and public health agencies and departments
> including FDA, HHS, and USDA.
>
> The message fish can and should be part of a healthful diet is sound.
> Messages that may be interpreted as no fish are not a benefit to
> public health.
>
> In addition to the necessary research that must be done to ensure
> advisories inform and not result in negative behaviors, other research
> will be helpful, as well, in providing FDA with further information on
> fish and methylmercury exposure.
>
> We are now pursuing one such research direction. While it is true that
> methylmercury exposure poses health risks, it is also true that fish
> consumption confers real health benefits. These benefits would be lost
> if consumption of all fish\--and I repeat all fish\--were reduced in
> an attempt to reduce methylmercury exposure where action is being
> based on incomplete information.
>
> Clearly, a comparison of the methylmercury
>
> risks to the risks of reduced fish consumption is necessary to ensure
> that any policy, including the way in which advisories are worded,
> helps rather than harms public health.
>
> Through the NFPA Research Foundation, a project is now underway to
> review the data published on the impact to health of dietary exposure
> to methylmercury, and evaluate and compare the risks of benefits of
> efforts aimed at influencing the consumption of fish.
>
> Some might call this a risk-risk evaluation, others a risk tradeoff,
> but it is currently being undertaken, and you will hear more about
> this research from the project director, Dr. Joshua Cohen, of the
> Harvard Center for Risk Analysis.
>
> In summary, while FDA\'s revision of its consumer advisory is still a
> work in progress, the agency is to be commended for its efforts to
> carry out the recommendations of the Food Advisory Committee.
>
> We believe consumer testing is necessary,
>
> will be helpful to ensure that the consumer advisory meets the goal of
> better informing the
>
> at-risk population on ways to decrease their methylmercury exposure
> while not resulting in behaviors that may direct them away from all
> fish and other seafood.
>
> Finally, we must remember that consumer advisories and messages
> concerning public health are only tools for public health education,
> and are not complete solutions in and of themselves, nor should they
> be.
>
> NRPA thanks you, FDA, EPA, and the Advisory Committee for the
> opportunity to provide these comments.
>
> DR. MILLER: Thank you.
>
> Just a quick question. Dr. Dwyer has several times raised this
> possibility of expanding the database from which these advisories are
> made with data from the industry.
>
> Would NFPA be willing to cooperate in developing that data?
>
> MS. APPLEBAUM: NFPA has been involved in
>
> developing a number of data on a number of issues. There was a recent
> publication on the levels of methylmercury in fish recently reported.
> I apologize, Dr. Sanford, for not knowing exactly the publication, but
> when we are asked to provide such information, we have stepped
> forward.
>
> DR. DWYER: Would that be publicly available, going into a database
> that was\--or is it just your own publication?
>
> MS. APPLEBAUM: The publication, it\'s in the peer-reviewed literature,
> so there is information out there.
>
> As with anything, Dr. Dwyer, we would talk with our companies in terms
> of developing ideas, but if the data is there, we would want to
> provide it to the stakeholders.
>
> DR. DWYER: I have done a lot of giving advice to people about eating
> things and not eating things, and very often they don\'t do either of
> those things.
>
> Can you think of any government advisory that has ever substantially
> decreased consumption,
>
> and if so, what are those advisories?
>
> MS. APPLEBAUM: Well, I think in terms of messages that were given out
> earlier, the last decade and in the late \'80s, relating to
> cholesterol and fat, consumers heeded it.
>
> What was missing in that point, and, you know, when you look at the
> National Cholesterol Education Program and the progress that was made
> there, that was one that I think that had benefit, but when you look
> in terms of the focus exclusively on fat messages and the impact in
> terms of overweight and obesity, in terms of the lost message on
> calories, we have to be very careful as it relates\--and you know this
> better than I do\--as relates to giving consumer messages, so that
> easy messages in terms of the easy take home, is not what drives the
> issue of bigger impact.
>
> That is why, at the end, in terms of my final comments, advisories and
> messages are only one part, one tool in terms of a public health
> education program, and not solutions in and of themselves.
>
> DR. MILLER: Thank you.
>
> The next speaker is Dr. Diana Zuckerman from the National Center for
> Policy Research.
>
> DR. ZUCKERMAN: I am Dr. Diana Zuckerman, President of the National
> Center for Policy Research for Women and Families, and our Center is a
> think tank that works to improve the health of women, children, and
> families, and we don\'t take contributions from anyone that makes any
> product that we might at some time say something nice about or
> something not so nice about.
>
> Like you, our goal is to ensure that scientific information is made
> understandable and available in ways that safeguard everyone\'s health
> and make sure that consumers can make educated choices.
>
> I have been attending FDA meetings on this topic for several years,
> and I am glad to see real progress, and I really thank you because I
> think a lot of that progress is really due to this Advisory Committee.
>
> However, the proposed FDA/EPA advisory is
>
> confusing, as we have heard people say, and the FDA\'s own scientists
> have found that the 12 ounce limit is too high to reduce mercury
> levels in women.
>
> As an epidemiologist, I feel very strongly that data are essential in
> answering the questions we need to answer and providing information.
> According to the information provided to this Advisory Committee
> yesterday by Dr. Carrington, the proposed limit of 12 ounces of fish
> per week would not significantly decrease methylmercury levels in
> women.
>
> According to the FDA\'s analysis, 12 ounces of tuna, particularly
> albacore tuna, and some other fish in the moderate category is just
> too high. So, the question is why is it in this draft advisory.
>
> Your task is incredibly difficult and very important, and we are
> counting on you. You need to make sure that adults are warned, in way
> that they will understand and in ways that they will remember, so that
> children and pregnant and
>
> nursing women are not harmed. So far the FDA has not succeeded in
> getting the message out to the people who really need it.
>
> Our Center specializes in explaining research-based information to the
> general public, and we have been working very closely with the
> National Cancer Institute on some patient booklets, and I think it is
> informative, the experience we have had with them.
>
> In preparing a patient booklet, they hired a specialist to translate
> all this research-based information that was going to patients, to
> translate into simple words and simple sentences that were suitable
> for women at the middle school reading level.
>
> That seems very dramatic to me and drastic, and I have to admit I
> didn\'t like it at all because you lose so much information when you
> are trying to get down to that middle school level, but apparently
> that is what NIH does for their patient booklet, they aim for a middle
> school level because there are, in fact, a lot of people in this
>
> country who, although they may be high school graduates, cannot read
> at a higher level than that.
>
> They call this plain language. The words have to be short, so they use
> words like mercury instead of methylmercury, they might even use words
> like often instead of frequent. But it isn\'t just the words, it is
> really just dumbing-down the vocabulary.
>
> It is also having ideas that are simple and straightforward and clear.
> So, using that as a guideline, a methylmercury advisory needs to say
> at least two things. Some fish, actually many fish are very good for
> you, and some fish are potentially dangerous if you are pregnant or a
> child or a woman who is nursing.
>
> Now, we think that people can understand these two messages if you
> explain which fish are safe, which fish are not safe, and the ones in
> between. But we think what is wrong with the advisory as it reads now,
> is that it tries to do something a little different.
>
> It tries to say fish are good, and these
>
> are the fish that are bad, and that is not logical. That doesn\'t
> follow logically and it feels like spin control. It doesn\'t feel like
> advice for consumers, it feels like some kind of politically correct
> effort to say fish are good, but just these fish are bad, when, in
> fact, really what you want to say is these are the fish that are good,
> and these are the fish that are bad, and you actually might have to
> say bad even though we don\'t like to use terms like that.
>
> With all due respect, I am just shocked by the way this process works,
> because I know from my experience with the National Cancer Institute
> that for \$500 or \$1,000, you hire one of these specialists, they
> write it, they rewrite something, make sure that the language is
> clear, the ideas are clear, but that it is still research based, and
> it takes them a few hours to do this. It is not a huge task.
>
> I also agree that a simpler way to do this is to have separate
> advisories, one for pregnant women, nursing women, a different one for
> children,
>
> and a different one for other adults, and perhaps one for people with
> heart problems. That\'s new information for me, I didn\'t know about
> that.
>
> It feels to us that the underlying problem is the FDA\'s
> reluctance\--and perhaps EPA\'s reluctance\--to say that some popular
> fish are relatively high in mercury.
>
> They just don\'t want to say it. But we have to get over that because
> if we don\'t clearly say which fish are dangerous and which fish are
> safe, people really will come away with the wrong message, and that
> will be more dangerous for everyone.
>
> DR. MILLER: Could you summarize, please.
>
> DR. ZUCKERMAN: Yes, I can. Thank you.
>
> I just want to say that I know that some experts will be pointing out
> that we don\'t know exactly how dangerous methylmercury is for
> pregnant women and young children, we don\'t have all the data we
> need.
>
> It might not be as dangerous as some people think or as the Institute
> of Medicine has
>
> estimated, but none of us would want to include our children or our
> grandchildren in that kind of study to expose them.
>
> In our experience, the Institute of Medicine, which is very concerned
> about this, is very cautious, so we take their concerns very seriously
> and we hope that you will in trying to figure out how to present this
> information quickly.
>
> I think that is the other thing, not to delay this too much, not to
> use the proposed advisory as it is written, but have something that is
> simpler to understand, but that gets some of that information out as
> soon as possible.
>
> Are there any questions?
>
> DR. MILLER: Comments or questions? Yes.
>
> DR. ACHOLONU: You are advocating that if the EPA puts out different
> kinds of advisories, wouldn\'t this open a can of worms, will this not
> cause confusion, and wouldn\'t several groups be clamoring and asking
> for their own?
>
> DR. ZUCKERMAN: Well, I think that an advisory, if it is very
> complicated, even saying
>
> women who are pregnant, women who might become pregnant, and women who
> are nursing, that alone is somewhat complicated, and when you add
> children to that, and you are not exactly sure what the levels are for
> children, I think it is very difficult.
>
> So, I think it is fine to have short summaries that are targeted for
> different groups, and then maybe have the one part that is the same
> for everybody, which explains a little bit about what methylmercury is
> or what mercury is, and why is it potentially dangerous.
>
> So, I don\'t think so. I do think you might even need a different kind
> of advisory for physicians. They are not going to want the 8th grade
> version of this. I think it would be fine to have a more sophisticated
> version, they would want a short one, but maybe not 8th grade level,
> for physicians than the one for the general public because the needs
> are somewhat different.
>
> DR. ACHOLONU: So, about how many do you think we should have, two,
> three, or four?
>
> DR. ZUCKERMAN: I think it would be very
>
> helpful to have simple ones for pregnant women, women who might become
> pregnant, one for kids, and one for other adults who are not of
> reproductive age at the simple level, and then perhaps one that
> combines all of those things for a more sophisticated audience, such
> as physicians.
>
> DR. MILLER: Thank you.
>
> The next speaker is Dr. Joshua Cohen of the Harvard Center for Risk
> Analysis.
>
> DR. COHEN: My name is Joshua Cohen. I am the senior research associate
> at the Harvard Center for Risk Analysis at the Harvard School of
> Public Health. I am here today to discuss the work our Center is
> conducting to inform policies addressing the presence of methylmercury
> in commercially caught fish. I appreciate the opportunity to address
> the FDA Food Advisory Committee today.
>
> I will be describing the work related to a grant funded by the
> National Food Processors Association Research Foundation. That grant
> has also funded by travel expenses today, and I do not have any
> connection to the sponsors of this
>
> meeting.
>
> The issue of methylmercury in commercially caught fish is particularly
> difficult to address because fish consumption has health effects that
> cut two ways. Methylmercury is known to be a neurotoxin to which
> unborn children may be especially vulnerable. Methylmercury may also
> affect adults with recent studies suggesting that it may increase the
> risk of coronary heart disease.
>
> On the other hand, fish are a rich source of nutrients, in particular
> omega-3 fatty acids, that are thought to aid neurodevelopment during
> the perinatal period. These nutrients may also reduce the risk of
> mortality associated with coronary heart disease in adults, so it cuts
> two ways.
>
> In a project funded by the NFPA Research Foundation, the Harvard
> Center for Risk Analysis is currently addressing this policy issue by
> quantitatively comparing the health risks and benefits of fish
> consumption. The idea is that policies affecting fish consumption in
> either direction also influence these risks and benefits.
>
> The only way to know whether a change in fish consumption is
> beneficial on net is to quantify the risks and benefits and then to
> compare them. The Center for Risk Analysis is currently drafting
> several manuscripts that quantify the relationship between fish
> consumption and these various health effects. A future paper will
> aggregate these results and quantify the net health benefits or the
> net health loss of hypothetical changes in fish consumption.
>
> The risk tradeoff analysis we are conducting in the context of
> methylmercury in fish differs significantly from the evaluation of
> methylmercury conducted by various regulatory agencies. For example,
> EPA\'s reference dose attempts to identify a level below which
> exposure to methylmercury is of limited concern.
>
> While this benchmark can be useful for the purpose of identifying
> exposures that are worthy of further consideration, it does not help
> decisionmakers to determine how badly public health will be affected
> if exposures exceed this limit,
>
> nor does it help us to understand the public health costs that may be
> associated with even those exposures below this limit.
>
> Importantly, the reference dose does not take into account the
> nutritional benefits of fish consumption. To complicate matters, it is
> not clear how the advisory affects fish consumption patterns as has
> been discussed here extensively today.
>
> The key point is this. The focus on determining the impact of an
> advisory on the proportion of women above the reference dose is
> inadequate from a public health perspective. To know if an advisory is
> a good idea, we need to understand how it will influence fish
> consumption for the whole population, not just the target population,
> how the change in consumption will influence both exposure to
> methylmercury and the intake of nutrients, and how these changes will
> influence the probability of different health effects.
>
> Because such an analysis has not been
>
> conducted, we do not know what the net public health impacts of
> advisories are. We hope that the project we are currently involved in
> will help to shed light on this issue.
>
> DR. MILLER: Thank you.
>
> Comments or questions?
>
> DR. LUND: Dr. Cohen, I didn\'t hear the date when you expect some of
> these results to be coming out.
>
> DR. COHEN: Well, the manuscripts are virtually complete. We are going
> to be submitting them for peer-reviewed journals, and, of course, you
> know that is an uncertain proposition in terms of the timing, but we
> would hope that a year from now, these papers will be in the
> peer-reviewed literature.
>
> DR. DURST: You are talking about developing an advisory for the entire
> population, which, since this one which is narrower, is already fairly
> complicated, would you agree with the previous speaker in that a
> number of different advisories would be more beneficial in terms of
>
> directing it towards the various populations?
>
> DR. COHEN: Actually, perhaps I wasn\'t clear. I am not advising or I
> am not suggesting that an advisory for the whole population is a good
> or a bad thing. What I am saying is that whatever advisory is
> considered, be it the one that EPA and FDA described this morning or
> anything else, what is important is to figure out how that is going to
> change people\'s fish consumption patterns and then trace that through
> to changes in the incidence of various health effects.
>
> What I was saying in relation to the population at large is that even
> if you target an advisory to pregnant women, it may influence
> consumption among other members of the population, and that needs to
> be taken into account.
>
> DR. HEIMBURGER: You have put us in a very difficult position by
> telling us that you have data that you are submitting for publication
> and an advisory could come out very soon, well before your\--I don\'t
> know, I am new to the process, maybe it won\'t come out soon\--well
> before your data are
>
> published.
>
> Can you give us any indications of how your data might specifically
> impact the advisability of any of the recommendations made in the
> advisory?
>
> DR. COHEN: Unfortunately, as you know, when you go into the
> peer-review process, you know, the peer reviewers can cause you to
> change things, so I think it would be premature for me to say, well,
> the answer is X and then next year it turns out to be X plus or minus
> something, and that is just confusing for anybody.
>
> DR. HEIMBURGER: Well, then, what you have done is you have put us
> into\--I mean data are always be in flux, there will always be new
> data come out, and we really don\'t know how to respond.
>
> DR. COHEN: Okay. Well, I mean I would say what we are providing isn\'t
> new data, it\'s an aggregation of the existing data. What I am really
> trying to stress here is that before the government goes ahead and
> puts out an advisory that is going to affect people\'s behavior, they
> need to
>
> understand how it is going to influence that behavior, and if the
> government doesn\'t understand that, then, maybe it is not a good idea
> to do it.
>
> Otherwise, I mean you don\'t know, you just don\'t know if this is
> going to be net good or net bad. It might be net good, but you don\'t
> know.
>
> DR. MILLER: The problem really is that if you have a situation that
> has a significant public health outcome, the longer you wait, the
> greater the risk is.
>
> The other point is that, and I still think it is something for this
> committee to suggest even though it is self-evident, that this process
> that FDA and EPA are going through ought to be an ongoing one and that
> changes in the advisory should be made on the basis of relatively
> short periods of time as new data becomes available and a new analysis
> is going to be available.
>
> I mean what struck me about this business going through the last two
> meetings is how things seem to be changing every month. There are new
> data, there are new approaches to the data, there
>
> are new ways of analyzing the data, and if we waited until the
> questions were all answered, there would be no advisory at all.
>
> I understand the point you are trying to make and I agree with it, but
> the question is a matter of time, and you are not prepared to share
> that.
>
> DR. COHEN: I mean we don\'t even have the aggregation yet, so even if
> I wanted to, I couldn\'t share it and besides it is not even in the
>
> peer-reviewed literature.
>
> DR. MILLER: I don\'t mean that critically. I am just saying that is
> the reality of life for the people who are going to write this thing.
> We are not going to write this thing. This committee is going to make
> recommendations to the people who will write this thing, whatever
> point they take.
>
> But I would suggest that the committee consider that kind of
> recommendation to be made to the agency, otherwise, if we are trying
> to pick things out, we are never going to get any kind of
> recommendation.
>
> DR. COHEN: Yes, I am I recognize obviously, you know, things have to
> be done in a timely manner and while you wait, people are living and
> being exposed to things. I guess I would urge you to advise FDA and
> EPA to at least address the broader public health question, that is,
> what is the net overall effect of this, not just focus on the mercury
> or on the nutrients. I mean you have to look at things holistically,
> otherwise, you don\'t know if you are doing net good or net bad.
>
> DR. MILLER: Good. Norman.
>
> DR. KRINSKY: Could you just tell me how you were able to evaluate how
> the advisory would alter fish consumption. Do you use focus groups of
> some equation?
>
> DR. COHEN: No. What we have done, the focus of our work is essentially
> looking at dose response, to say if omega-3 fatty acid consumption
> intake increases by thus and so, what benefits does that confer,
> likewise, for methylmercury on the adverse health effects.
>
> It is very difficult. We have not focused
>
> our research on looking at how fish consumption for a particular
> advisory would affect things. We will consider some hypothetical
> changes to illustrate what the net impact will be, but, of course,
> without knowing the exact wording and conducting the type of research
> which FDA and EPA have described, but I think they need to do more and
> do more extensive research to figure out how the population, fish
> consumption will be affected, you know, that the overall picture is
> not going to be complete.
>
> So, our component is going to be the
>
> dose-response relationships for the omega-3 fatty acids and for the
> methylmercury, which is to think from an RfD. An RfD, reference dose,
> I am sorry, does not tell you what is going to happen below or above,
> as I think someone even mentioned on the panel this morning, the
> difference between 0.13 micrograms per kilogram per day, and 0.1, you
> know, the RfD says 0.13 is bad, 0.09 is okay. Well, in reality, that
> is not true. There is a gradation, and that is what we are going to
> try to explain
>
> quantitatively, so that the net benefits of changes in fish
> consumption or the net adverse effects can be characterized.
>
> DR. MILLER: Thank you very much.
>
> Is this an important question, Johanna?
>
> DR. DWYER: Of course, Dr. Miller, all of my questions are important.
>
> \[Laughter.\]
>
> DR. DWYER: Thank you for clarifying what you are up to. What I was
> wondering, since the focus of the analysis is primarily on omega-3
> fatty acids, two questions.
>
> One is accounting for other sources in the diet than fish, and,
> secondly, it is my understanding an evidence report has been in
> process, I think it is about a year, through NIH. I assume that you
> would be taking that into account in your analysis, or have you
> already submitted the manuscripts? I gather it will be out in two or
> three months.
>
> DR. COHEN: First of all, we have not already submitted the
> manuscripts. We focused on
>
> the omega-3 fatty acids because that seems to be the key issue in
> terms of nutritional benefits.
>
> Optimally, one would want to look at not just the omega-3 fatty acids,
> but on the other nutritional benefits. But, you know, in order to get
> this done, this we think is a very useful first cut, and even so, it
> is taking time.
>
> Now, the NIH report, I am not sure I am familiar with that.
>
> DR. DWYER: I think it is through the evidence-based practice centers,
> and I know it has been in press for about a year.
>
> DR. COHEN: On omega-3 fatty acids?
>
> DR. DWYER: That is correct.
>
> DR. COHEN: I am trying to remember. I think we have that report, but I
> can\'t\--
>
> DR. DWYER: If you do, that is surprising because I don\'t believe the
> NIH has it yet.
>
> DR. COHEN: Well, I don\'t know. Again, I can\'t remember exactly which
> government reports we have looked at, so I guess I just don\'t know
> the answer to that question without knowing exactly
>
> which report you are talking about.
>
> DR. MILLER: I think we had better move on. Thank you.
>
> The next is Mr. John Stiker from the Bumble Bee Seafoods and U.S. Tuna
> Foundation.
>
> MR. STIKER: Thanks for having me. My name is John Stiker. I am a
> Senior Vice President at Bumble Bee Seafoods, so in the spirit of
> disclosure, I work for tuna company.
>
> I had promised Dr. Acheson yesterday that I would include a little bit
> of kind of a Tuna 101, as I heard some of the questions about
> differences between white meat and light meat, where tuna are
> harvested, but I think I have only got about eight minutes, and I am
> going to be talking fast as it is, so I have included that as an
> appendix in the presentation that has been handed out.
>
> DR. MILLER: Five minutes.
>
> MR. STIKER: I thought I had eight, so I will go really fast. So, if
> there are questions on that afterwards, I would be happy to field
> them.
>
> I have titled this presentation The Curve
>
> Has Changed, and the curve that I am referring to is the curve that we
> tend to ground ourselves in, which is the NHANES curve, which was
> plotted out in the July 2002 Food Advisory Committee.
>
> This one provided critical data on actual blood levels among American
> women and here is where the 7 to 8 percent of women over the EPA RfD
> curve came in, which led to that often cited 300,000 babies at risk
> claim.
>
> Worth remembering, though, as we think about it, is that the average
> safety and uncertainty factor for that population that was above the
> EPA reference dose was, on average, still 8-fold, and none even
> approached the Faroes NOAEL.
>
> So, from the tuna industry perspective, we do consider the reports of
> the methylmercury health crisis to be overblown. We do, however,
> support the concept of minimizing methylmercury exposure, but we
> believe it should be done responsibly, balancing the need to maintain
> or even increase overall seafood consumption given its health
> benefits.
>
> So, the question that we ask ourselves as we are now four years
> post-NHANES and considering revising the advisory is do we have any
> new data which suggests that food consumption or methylmercury intake
> is up since NHANES or even that it is static, or do we have new data
> which suggests that seafood consumption and methylmercury intake is
> down since the NHANES and, since the advisory, is the curve improving.
>
> So, let\'s take a look quickly at what the data tells us about the
> impact of the advisory. First, the study published by Dr. Emily Oken.
> Hopefully, you have all seen it in Obstetrics and Gynecology,
> demonstrated a dramatic dropoff in fish consumption among pregnant
> women in Massachusetts post-advisory.
>
> For canned tuna, the percent change in consumption was down 28
> percent\--ouch\-- for overall seafood, 17 percent. I laugh about it,
> but I would tell you that I am not sure that is even the impact that
> you want to have with that advisory.
>
> Yet, despite the fact that many women may
>
> not read it, you get the headlines like this morning\'s Washington
> Post, \"Federal warning on tuna planned.\" I can tell you exactly what
> impact that is going to have on consumption.
>
> So, it is being heard and felt throughout the seafood industry. In
> fact, here is the data released by NOAA and NMFS on seafood
> consumption, and you can see what happened to tuna. We used to refer
> to tuna as the most popularly consumed seafood in America.
> Post-advisory, it\'s not anymore. In fact, in 2001, post-advisory, we
> experienced a 17 percent decline in consumption.
>
> We had a very modest recovery in 2002, but that is a 14 percent
> two-year drop in consumption post-advisory. Contrast that versus the
> years that the NHANES data was collected. So, in the NHANES years, we
> were seeing about 3 1/2 pounds of tuna consumption per year. That has
> dropped notably since the advisory.
>
> To put that in perspective from a relative health point, however, you
> can look at ounces per week as we think about the 12 ounces per week
>
> number. From our standpoint, we have taken consumers who eat very
> little canned tuna to begin with, about 1.1 ounces per week, and
> encouraged them to eat even less.
>
> The average per capita consumption, as you see there, is about 1 ounce
> per week. We split in our industry about two-thirds or sometimes 70
> percent light meat, one-third or 30 percent white meat, which suggests
> average albacore consumption of consumers of 0.3 ounces per week. Even
> at the 95th percentile, which starts to get pretty far up there,
> canned tuna consumption is less than 5 ounces per week or less than 2
> ounces per week of albacore.
>
> This is despite the fact that tuna and, in particular, albacore tuna
> is the second highest source of omega-3 fatty acids of all common
> seafoods and certainly the most affordable.
>
> As you look through that list and think about a trip to your local
> grocery store, you are going to pay 3.99 to 4.99 a pound for almost
> every seafood that is up there. Chunk light tuna
>
> typically sells, as you will see in the back of your packet, for about
> 69 cents a can, albacore sells for about 99 cents a can. It is a
> terrific economical value for the U.S. consumer.
>
> So, while the perceived risk may be abated, as Dr. Cohen seemed to
> allude, the tradeoff by reducing omega-3 consumption from canned tuna
> is very real, something is going on, and we know that the benefits to
> omega-3\'s to both mother and child are well documented from fetal
> brain and retinal development to achieving full-term delivery, to
> other maternal benefits.
>
> At Bumble Bee, we wondered where is that tuna volume going. Tuna is
> unique among all fish in that it is the only fish commonly used in a
> sandwich. In fact, you can see there that over half of our consumption
> is in a tuna sandwich. So, it is not easily replaceable by other
> seafoods. You are not going to have a salmon sandwich or a tilapia
> sandwich, it just doesn\'t happen.
>
> So, we commissioned Information Resources, which is a syndicated data
> company, to conduct a
>
> study on that topic using household panel data. As you can see here,
> here is how tuna stacks up in the world of sandwiches. The most
> commonly consumed sandwich in America today\--I don\'t know this\--is
> the ham sandwich, followed by PB&J, hamburgers, turkey, cheese, hot
> dogs. Tuna is Number 7.
>
> We are pretty pleased with that fact. We would love to see it higher,
> but there we stand.
>
> What IR did is they looked at pregnant households in their household
> panel comprised of thousands of households who became pregnant prior
> to the FDA advisory. Then, they looked at a set of households who
> became pregnant post-advisory to take a look at what happened to their
> seafood consumption.
>
> Prior to the advisory, households becoming pregnant would typically
> tend to increase their seafood intake during their pregnancy, not by a
> lot, but given the relatively low starting base of seafood consumption
> in America, we would consider this to be a good thing, a healthy
> response as they increase a food that is really good for them.
>
> Post-advisory, as we saw in the Oken and the NOAA data, seafood
> consumption went down relative to control, but the page I want to
> focus on is the next page, which shows what happened to sandwich
> replacements.
>
> Well, sliced lunch meat goes through the roof. Prepared pasta dinners,
> which is food like Chef Boyardee, microwaveable dinners, packaged
> turkey, hot dogs, packaged baloney are all increasing for these
> pregnant women.
>
> So, these households, which aren\'t even close to eating 12 ounces a
> week of seafood, they are buying on average 6 ounces or less for the
> entire household, are now decreasing their consumption of seafood and
> instead increasing their consumption of what we call shelf-stable
> convenience foods, which is microwaveable packaged dinners, not
> terribly good for you, and deli meat sandwich alternatives. I shudder
> to tell you what those look like.
>
> I know Rona Applebaum wouldn\'t want me to contrast versus other
> foods, but it is out there,
>
> there it is. In fact, the next page gives you that specific comparison
> of tuna relative to the other sandwich alternatives. This is pulled
> straight from the USDA Nutrient database.
>
> You can take a look at the nutritional benefits of things like ham,
> hamburgers, turkey, cold pack American cheese, hot dogs, and compare
> those versus tuna, and what you will generally find is that on a whole
> host of major health benefit attributes, tuna outperforms them.
>
> What you see there is everything in yellow is a value that is worse
> from a nutrient and health standpoint than tuna.
>
> DR. MILLER: Mr. Stiker, could you summarize.
>
> MR. STIKER: Yes, I can, sir.
>
> Our conclusions. At the time that the advisory was issued, we
> perceived there was no immediate health risk from methylmercury, no
> U.S. consumers were even close to the Faroes NOAEL.
>
> There is no new data since NHANES that suggest you need to make the
> advisory more
>
> restrictive. On the contrary, there is substantial data that the March
> 2001 advisory had a dramatic impact on seafood consumption by pregnant
> women, perhaps even swinging the pendulum too far.
>
> The advisory is a blunt tool. Even carefully phrased language of
> moderate is often taken by U.S. consumers as cease. The data suggests
> that the curve has changed since the
>
> 1999-2000 NHANES. Further data suggests that pregnant women are being
> driven to alternatives to canned tuna, which pose their own and
> different health concerns. It is not risk free.
>
> Our perception is it is not proven at this point to make the advisory
> more restrictive. It appears to be working. It is doing what you want
> it to do, and the impact of driving down seafood and canned tuna
> consumption further brings other real health risks.
>
> Our recommendations. Continue combining the FDA and EPA advisories. We
> think that is terrific to minimize confusion. Given the extremely low
> levels of seafood consumption by U.S.
>
> consumers, we think there is room even for a more positive tone in the
> advisory to actually encourage more seafood consumption by the vast
> majority of U.S. women who aren\'t eating enough.
>
> Definitely include the caveats that are currently in place - 12 ounces
> a week, ensure a variety, eliminate the high-end species. We believe
> there is no health-based reason to make the advisory more restrictive
> even implicitly. Only call out canned tuna if you are really
> comfortable with the health implications of moving more pregnant women
> to deli meats, baloney, hot dogs, cheeseburgers.
>
> If you still feel you must call out canned tuna, please, do it in a
> responsible way that assures consumers that both albacore and light
> meat are extremely safe, and follow up to the NHANES data with current
> data to assess the impact of the advisory.
>
> It is hurting the seafood industry, but that wasn\'t I am sure your
> intent, nor is it something that you should be terribly concerned
>
> with. Public health is what you are here for. But I can tell you it is
> having an impact and it is working.
>
> That\'s all for my formal presentation, but I am happy to take
> questions on that or the appendix that is included, as well.
>
> DR. MILLER: Yes.
>
> MS. HALLORAN: I have two questions. The first, can you tell us the
> relative omega-3 content of albacore versus light meat, is it the
> same, or is one higher than the other?
>
> MR. STIKER: Yes, ma\'am, I can. In fact, if you go to page 7, you can
> contrast canned albacore versus canned light. It is about almost 4
> 1/2, 5 times more omega-3 in albacore than there is in light meat.
>
> MS. HALLORAN: The second question would be if the advisory were to
> state that pregnant women should avoid albacore, but the advisory
> positive encouraged them to eat more light tuna, or indicated that
> light tuna was safe to eat, what would the impact on the tuna industry
> be of that in
>
> rough terms, or can\'t you speculate?
>
> MR. STIKER: I would be happy to speculate. First, I will attack it
> from kind of a public health standpoint. I think there are some
> consumers who would shift their purchases from albacore to light meat,
> which would bring with it concurrent reduction in omega-3 intake.
>
> I think there are some consumers who are albacore loyal. You will see
> in the appendix, there is a picture of what a can of albacore looks
> like versus a can of light meat, and it is a very different quality
> product.
>
> Personally, I am an albacore eater and I am not a huge fan of light
> meat. I would switch to lunch meats, hot dogs, cheeseburgers. Then, I
> think there are a fair number of people who will not take away the
> message of, hey, light meat tuna is okay, but albacore is more
> concerning. I think they will take away federal warning on tuna
> planned, and simply stop eating tuna altogether.
>
> Anecdotally, my sister-in-law is pregnant. She knows I work for a tuna
> company. She told me
>
> she has stopped eating tuna altogether. She only eats it once or twice
> a month, and she has stopped eating it altogether because she has been
> hearing so much about mercury in tuna. That breaks my heart, not just
> as a business person, I mean it is good for her pregnancy, it is good
> for her fetus. She should be eating tuna.
>
> DR. MILLER: We will take one more question and then we have got to
> break.
>
> DR. APOSHIAN: I have an 2002 annual report of the United States
> seafood industry, and on this it claims that of all the tuna landings
> by U.S. vessels between 1992 and 2001, for the year 2001, albacore was
> only 12 percent of the tunafish caught. So, how can it be a great
> catastrophe if albacore consumption went down? You have still got all
> the other tunafish.
>
> MR. STIKER: You are actually comparing kind of apples to oranges there
> I believe there, sir. I think what you are comparing is landings by
> the U.S. fleet, which only comprises a small portion of the overall
> tuna fishing fleet in the
>
> world.
>
> The data that we are looking at is U.S. consumption. So, U.S.
> consumption is closer to about a third that is done in albacore, not
> the 12 percent, sir.
>
> DR. APOSHIAN: So, essentially, if albacore was not sold, it would not
> hurt the U.S. fishing industry.
>
> MR. STIKER: Correct, which is a very small proportion of the overall
> world fishing fleet located primarily in the western Pacific fishing
> for light meat product.
>
> Yes, sir.
>
> DR. MILLER: I made a mistake. We have one more speaker. Thank you.
>
> MR. STIKER: Thank you.
>
> DR. MILLER: We have one more speaker and then we can break for lunch.
>
> Dr. Lillian Beard.
>
> DR. BEARD: Thank you and good afternoon.
>
> I know the hour is late, I will not be taking very much time. As you
> know, as you have
>
> just heard, I am Dr. Lillian Beard, and I have no financial
> relationship with either agency.
>
> I have been practicing pediatrician in the Washington metropolitan
> area now for about 30 years, and I am also an Associate Clinical
> Professor of Pediatrics at the George Washington University School of
> Medicine, and an Assistant Professor at the Howard University College
> of Medicine.
>
> I am here today to address my concern that the mercury advisory may in
> fact be hurting more than helping pregnant women and women who might
> become pregnant and could have an adverse effect on their young
> children.
>
> As has been mentioned a few times earlier today, a Harvard Medical
> School study published in the August 2003 Journal of the American
> College of Obstetrics and Gynecology, entitled \"Decline in Fish
> Consumption Among Pregnant Women After a National Mercury Advisory\"
> concerns me greatly.
>
> The study showed that after reading the advisory, women who were
> consuming 2 to 3 servings
>
> of fish a month reduced their consumption to only 1 to 2 servings a
> month. Remember that many organizations including FDA and the American
> Heart Association have recommended 2 to 3 fish servings a week.
>
> These statistics alone tell us that women are not consuming enough
> fish if they are only eating it 2 to 3 times a month, and if they have
> cut that in half, it should sound an alarm.
>
> While the study was limited to the eastern part of Massachusetts, it,
> nonetheless, raises the question of whether this is a trend
> nationwide, in which case we should all be very concerned.
>
> A reduction in seafood may be appropriate if individuals were close to
> the 12 ounces a week recommendation from FDA. However, market surveys
> continue to suggest that households are purchasing less than 6 ounces
> of seafood a week for the entire household, not just 1 individual.
>
> As Mr. Stiker pointed out, according to the Department of Commerce,
> there has already been a 10 to 15 percent reduction in the consumption
> of
>
> canned tuna over the last two to three years. Canned tuna is not the
> number one consumed seafood, shrimp is the leader, yet, the focus
> continues to be on tuna, which is by far the most economical means of
> providing a nutritional protein source for families, as well as being
> the second leading source for the omega-3 fatty acids.
>
> As a pediatrician, I do follow the guidelines established by the FDA,
> and I advise and counsel my parents accordingly about the importance
> of healthy diet and the need to eat a variety of foods including fish.
>
> I encourage my parents to include fish as part of their children\'s
> balanced diet and I discuss the health benefits for them and their
> children from eating fish. In my counsel to parents, I emphasize the
> importance of variety and appropriate portion sizes based on the
> child\'s age and size. My approach to diet and health has been to
> consider always balance and moderation.
>
> Young children already consume less seafood than adults. To make
> separate comments
>
> about this may unduly scare parents into not serving seafood at all.
> In the NHANES study, there were no children who exceeded the reference
> dose.
>
> I am concerned that we may be pushing mothers and women of
> childbearing age away from a safe and beneficial food, such as fish,
> including canned tuna. When advisories are difficult to interpret,
> they seem more confusing than helpful. The benefits of the omega-3
> fatty acids for eye and brain development of a baby are very
> important. Pushing women away from fish which provides them with this
> essential nutrient would be detrimental.
>
> Our zeal to protect women may in fact be doing them and their babies a
> disservice. I encourage you to provide the public, especially health
> professionals, pregnant women and women of childbearing age with
> simple, eat to understand guidelines that help us to understand the
> important benefits received from eating fish, and not just the scary
> concerns.
>
> This past summer, the United Nations World Health Organization
> gathered experts from around
>
> the world to evaluate the most recent information available on mercury
> and its neurodevelopmental effects on children. They recommended
> establishing a safe daily intake level that is twice that of EPA. Are
> we supposed to ignore their advice? Does it not have some relevance to
> the current review that is going on?
>
> In conclusion, I commend both the FDA and the EPA for attempting to
> provide one message rather than two and I sincerely hope that you will
> be successful in persuading the states to follow your lead, so that we
> ultimately hear one message, and not 52 messages.
>
> Thank you for your time and your attention.
>
> DR. MILLER: Any important questions or comments? If not, thank you.
>
> That brings us to the end of the public comments. We are going to
> break for lunch now. It is now quarter past the hour, I am going to
> ask you to try to be back here in 45 minutes, and then we will start
> discussions on each of the topics to see
>
> if we have any advice to offer to the committees.
>
> \[Whereupon, at 1:15 p.m., the meeting
>
> recessed, to reconvene at 2:00 p.m. this same
>
> day.\]
>
> A F T E R N O O N S E S S I O N
>
> \[2:00 p.m.\]
>
> **FAC Discussion and Comments**
>
> DR. MILLER: We have got a busy afternoon ahead of us and I have tried
> to clarify some of the responsibilities we have under the charge to
> try and simplify our work.
>
> There is very little we have to do with the reports from the
> subcommittees that we talked about the first two days. Unless there
> are some significant changes that we think should be made, the
> subcommittees will get copies of the transcripts and some of the other
> recommendations made, which were stylistic ones, will go the
> committees and they will make whatever changes need to be made.
>
> But if there are no major differences between the subcommittee report
> and our thinking, I would just like to accept these for the record in
> saying that the full committee has reviewed the report and has
> referred it to the Center Director for him to take action on the
> report.
>
> I really appreciate that. That allows us to go right to the
> methylmercury, which was a direct referral to this committee. As you
> all know, this was the second time that this committee has had a
> chance to review the agency\'s, and as you also know, there were 6
> recommendations made by the FAC, of which 5 were reviewed and
> developed by the two agencies involved, the most important one being
> that FDA and EPA work together to develop the advisory.
>
> The one area that did not, and I don\'t propose that we start
> discussion of it here, but just for the record, had to do with
> development of blood levels and the biomarkers for mercury. I would
> like to be able to refer that back to the agencies involved and repeat
> again that we think it is important for us to develop that data in
> order for us to tell what the biological consequences are of exposure
> to levels we are talking about.
>
> The other recommendations all have to do with the advisory, and there
> are a number of recommendations made by the various speakers, and I
>
> asked Jean Halloran if she would take the opportunity to make a very
> brief summary of some of these things.
>
> Much of what we talked about were in the materials submitted to the
> committee, we don\'t have to review that. I would like to focus on
> those important things that we want to tell the agencies that they
> ought to do, and I have asked Jean if she would make a brief note of
> what some of these things might be.
>
> MS. HALLORAN: This is a very intimidating task, but I will try and
> summarize our discussion, the points that were raised so far. That is
> what you want me to do, right?
>
> DR. MILLER: Exactly.
>
> MS. HALLORAN: In the discussion of the FDA exposure assessment, there
> wasn\'t much criticism or problems raised. Dr. Aposhian brought up
> this very interesting study of Holmes, et al. on autistic children. We
> had a discussion about whether there might need to be a special
> message for groups, this group and other groups, who might
>
> have a special situation.
>
> In the discussion of the focus groups, we agreed that this is a
> widely-used research tool on perceptions and that it was agreed that
>
> African-Americans were included.
>
> Dr. Scherer raised the interesting point that the real issue is how
> understand and perception translates into behavior, and asked if there
> were any follow-up plan. They didn\'t say that they directly planned
> specific follow-up although they would do some surveying.
>
> We then proceeded to the presentation on the advisory, and this is
> where the most interesting points, the largest number of interesting
> points were raised. I will just go through them chronologically from
> my notes. This is not in any order of importance or logic or sense.
>
> It was pointed out that mercury is an element. There was considerable
> discussion on and off about portion size and that the portion size
> matter is still confusing in the advisory and just
>
> generally as an issue.
>
> It was mentioned at various times should there be information on what
> consumers can eat. That information is not there. The issue of
> verbiage was raised, and the countervailing suggestion that the Ten
> Commandments is considerably more brief and covers more ground. This
> came up numerous times in numerous ways, though.
>
> The question of should there be special messages for the poor, for
> special type relations, such as Asians came up. The order of the
> points and the primacy effects was pointed out.
>
> The point was made that perhaps we need simple behavioral rules, and
> the Minnesota document was given u=as a good example of simple
> behavioral rules, also that not all consumers are the same and need
> access to different levels of information.
>
> The problem of names of fish came up again and again. Fish don\'t all
> have the same names and especially for the top four problem fish, we
> need to have all the names that they might go under,
>
> their aliases.
>
> The issue of what happens to the rest of the family as a result of
> dietary advice was raised, also, should there be a role in
> communication for food stores and restaurants and cafeterias.
>
> I think that is about it in terms of the major points. It is not
> everything, but those were the ones that came up to me as major
> points.
>
> DR. MILLER: Thank you, Jean.
>
> Any comments?
>
> DR. ALLER: I will make one, and, Jean, I think you did an absolutely
> fantastic job, because I had done something kind of similar on my own,
> and will add just a couple of points to it.
>
> I think that what we have been looking at, if we start with the
> starting point that the FDA has said and agree that the majority of
> the population is indeed okay, that this message is being crafted to
> improve on that smaller portion of the population for which the risk
> exists.
>
> Then, from there on, it starts to get a
>
> little touchy because that population is not all uniform and we have
> heard from a number of the speakers representing various different
> constituencies, be it cultural or economic basis, or what have you,
> about what that message may need to be and how best to target it.
>
> Kind of what I gathered from all of this is that certainly, for a
> segment of the population that we are trying to reach, we would need
> to be saying it\'s okay to eat fish as much as you want in this low
> concentration or this low-risk group, and to provide that information.
>
> I am not saying that that information needs to be provided to
> everyone, but that information does need to be available in some way,
> shape, or form for certain individuals or certain target groups.
>
> I think that in terms of message delivery and how that is done,
> certainly, the advisory that was crafted was well thought out, there
> was a lot of input from the public, and it certainly is appropriate
> for at least one portion of this group
>
> that is the target audience.
>
> There may, however, be other mechanisms and better ways to address
> other segments of that population, and the behavioral model that we
> had handed out, which certainly is an action item, this is what you
> need to do in a simpler format, and providing a list is yet I think
> another means to successfully communicate. We just need to make sure
> that the message is consistent among the formats.
>
> I think it came up both in our meeting a year and a half ago and again
> today, there is a great deal of confusion amongst species, and I am
> not sure that the advisory can address all of that issue. That, I
> think, is a much greater issue and extends far beyond this. But I
> think where possible, tilefish, I remember from our prior meeting a
> year and a half ago, the question we all are asking what the heck is a
> tilefish.
>
> I just for grins went on the Internet Monday and just typed in
> tilefish to see what I came up with, and sure enough, there are lots
> of
>
> different species and different names for different things, and I am
> not real sure of those, which are or are they all being targeted. So,
> I think that point particularly raises some confusion and it may be if
> cod or halibut has very similar types of things. I always thought that
> cod was cod, but this is my ignorance.
>
> So, I think that some of those are also issues of great concern.
>
> The issue of the first and the last message I think is also a very
> important one, and I don\'t know that we have reached agreement or
> consensus, but if the three points are
>
> indeed\--there are good things, here are things that you can do to
> limit your risk, and those are positively stated, and if there is
> something for which we want to ensure you don\'t do, I would make
> those our first and last points, and that gray area of a variety or
> what have you more in the middle, so that again we are stressing those
> beneficial fish, high in omega-3\'s and lower risk in mercury.
>
> I think that about sums it up, so I will
>
> hush.
>
> DR. MILLER: Thank you very much.
>
> DR. BUSTA: I fully agree with the first two comments, I think they are
> both covering areas. One additional item that I thought came up, or at
> least I was thinking of, is the idea of multiple advisories separated
> by the target groups.
>
> I think it is wonderful to have one message from two agencies. That, I
> think is magnificent because at the last meeting, the confusion
> between what EPA and FDA said is really bad. I like that one message
> there, but I think that, depending on the targeted group, several
> messages have to be developed because without an additional message
> for old men like me or things like that, the simple message for
> pregnant women and children is going to carry across so that it won\'t
> be differentiated. If you offer several advisories, that may enhance
> the differentiation.
>
> DR. ACHOLONU: With respect to names, it was stated that certain fish
> have different names depending on the population or the section of the
>
> country you are coming from.
>
> One of the speakers suggested that what will help here is putting the
> names, getting the scientific name, put it in parentheses. A
> scientific name is a scientific name and is very specific, so that we
> know the kind of tilefish we are talking about, because somebody that
> talked about tilefish, they thought about snapper and the rest of it.
>
> You may include the common names if you want, 1, 2, 3, but then at the
> end, in parentheses, put the scientific name of the fish, and I think
> this would be helpful. Thank you.
>
> DR. MILLER: Thank you.
>
> Dr. Lund.
>
> DR. LUND: Just two other points also on things that we talked about or
> came up during the discussion with the FDA staff and others who were
> presenting. One was the issue of eating a variety of fish, to what
> extent that is necessary and is helpful in limiting the amount or
> exposure to methylmercury.
>
> The other issue that I thought came up during that earlier part of the
> discussion also was how specific we ought to use quantitative data in
> here, in other words, going back to a body weight basis particularly I
> think for children more so than for the women or nursing mothers.
>
> DR. MILLER: Thank you.
>
> Dr. Russell.
>
> DR. RUSSELL: Just to second what you just said, I think the serving
> sizes for children has to be explicit as was suggested by one of the
> speakers.
>
> The other thing that I think I have come to believe after hearing more
> and more and re-reading the tuna guidance, I think the tuna guidance,
> as it is written now, is pretty unclear of what is good and what is
> bad. I mean you have to read it pretty carefully to be able to ferret
> that out.
>
> Finally, this doesn\'t really have to do with the advisory per se, but
> it has to do with the continual need for testing of not only more
> fish,
>
> but more samples of the fish we have. If it is true, as one of the
> speakers said, that there is only 6 analyses of shrimp, which is the
> number one eaten fish, I think that is much too few to make any kind
> of any statements with, and I just think we need a lot more data.
>
> I am almost wondering whether, at this point, it would be nice for EPA
> and FDA to come out with a joint advisory, but I think it has to be a
> moderate change from what we already have, because we are missing so
> much data still to come out with any kind of thing that is more
> definitive or complete.
>
> DR. MILLER: Thank you, Dr. Russell.
>
> Dr. Nelson.
>
> DR. NELSON: I would also like to thank you, Jean, for distilling all
> the commentary down so effectively. Following up on Marion\'s comments
> about the order of the message, I think that is particularly important
> because of the consistent message we heard at different levels about
> unintended consequences of this kind of warning or
>
> advisory.
>
> FDA and EPA considered that clearly in the design of their initial
> advisories and their work with the consumer groups, focus groups. Dr.
> Downer mentioned it in her practice, and we heard from a couple of
> other speakers about that, as well. Part of the challenge is to make
> sure that a balance is struck between protecting against potential
> risk of methylmercury and the good dietary and nutritional
> contribution that fish makes.
>
> DR. MILLER: Dr. Scherer.
>
> DR. SCHERER: I clearly come at all of this from a slightly different
> point of view, maybe a major different point of view than most of you.
>
> I sometimes get accused to stepping back and trying to look at the
> bigger picture more often than I probably should, but it seems to me
> that if I think about what this whole process is about, you know, the
> agency is responsible for collecting good data, providing sound
> conclusions from that data, and ultimately protecting the public\'s
> health.
>
> From what I think I have heard, and
>
> ultimately, I am getting to my level of expertise, is that I have
> heard that there does need to be more data. I guess part of my message
> is that I don\'t see this as an end product, that we arrive at an
> advisory and that\'s over, that there needs to be continuing
> collection of data, but it seems to me that the data that is within my
> area a little bit more, that is clearly still missing here is consumer
> consumption patterns, that we don\'t know about those subgroups that
> ultimately would become the targets of the advisory.
>
> Now, that is clearly difficult data to collect, but it seems to me
> that it is very critical data to really be able to target messages to
> people that are either high fish-consumption groups or minority groups
> that consume particular kinds of fish in higher amounts than the
> average population.
>
> When we go beyond that and we assume that we have good data, and I
> think at this point, obviously, there needs to be some thinking about
> do we have good enough data to go on, and think I hear
>
> the conclusion is yes, we have to go on and do something.
>
> It seems to me that the agencies\--and I say \"agencies,\" EPA and
> FDA\--have made real strides in beginning to put together a
> relatively\--a sound message. I congratulate them on the use of focus
> groups to help design that message, but they need to keep in mind that
> that is only the very first step, and the next level needs to really
> be understanding of what is it that people are reading in that
> message, what do they remember from that message, and what kind of
> action might they take as a result.
>
> If they are coming away from this message saying I am going to stop
> consuming fish, then, that is not what the data would support, I
> think. There needs to rethinking then of what that construction is.
>
> The warning that I would have is that the use of focus groups in
> constructing messages can be very helpful as long as we don\'t let the
> focus group control the content of the message, and even
>
> if they say I don\'t understand this particular aspect, that doesn\'t
> necessarily mean it should be thrown out.
>
> So, I am a little concerned that the message may not be reflecting the
> kind of science that is behind it to the extent that the consumers
> will come away with the same kind of conclusions we want them to.
>
> The final one, and I think Jean mentioned it, is the idea that we
> really need to be clear in terms of presenting specific kinds of
> behavioral steps that individuals can take. We all operate on the
> simple rules, and without those simple rules, the first point, don\'t
> eat these fish, is likely to be what people come away with would be my
> fear.
>
> So, I think there is still a lot of work to be done even when the
> advisory is ready to go at this stage.
>
> DR. MILLER: Dr. Heimburger.
>
> DR. HEIMBURGER: Yes. I want to lend my voice to all those who have
> said\--I think essentially, I would be uncomfortable with rushing
>
> to implement a revised advisory especially if it were a major revision
> to what was already out there.
>
> I think I heard enough that made me think that more harm could be done
> than good by making a major change, and it seemed to me that the
> message that we were hearing this morning sort of could be coalesced
> into four major categories.
>
> Number one, there needs to be a better science base. Some of that
> relates to the testing of fish more, maybe sharing data with industry
> or receiving shared data from industry, increasing the species detail
> with regard to the data, and then also, as expressed by the person
> from Harvard, assessing better what really would be the net effects,
> what are the net effects so far of the advisory and what might be the
> net effects of revision, because it seems as though the science base
> on all those accounts is not what it could be.
>
> Second, to make sure that the positive message is very strong. This
> came through again and again from a number of different people who
>
> testified, and I think we all ought to be concerned that the net
> effect could be one of reducing potentially the overall public health
> by turning people away from fish in an unintended manner.
>
> The third would be to create maybe a hierarchy of recommendations. The
> high, medium, low concept in terms of methylmercury appeals to me;
> stay away from these, choose these, that maybe somehow the positive
> and negative messages can both be embodied in that.
>
> That makes me think that the idea of either encouraging a variety of
> fish consumption or mixing it up is not helpful, and I would think
> that actually might need to be struck from the advisory entirely. I
> think there were some pretty compelling scenarios shown whereby that
> might actually have an unintended negative effect.
>
> Then, finally, to the fourth general category was to refine the
> populations that we are looking at, perhaps separate advisories,
> definitely separate recommendations for children, consider high-end
> consumers, as well, a bit more robust
>
> definition of what the populations are.
>
> If anything\--I am new to the process, so I don\'t know exactly why
> several of the speakers have said we need to do something quickly\--I
> am more prone as a newcomer to the process to say why are we compelled
> to do something additional to what has already been done quickly, and
> it seems to me that perhaps that caution would be the more prudent
> approach.
>
> DR. MILLER: I think in terms of the latter issue, it is pretty
> straightforward that there is a general and increasing belief that
> there is a public health problem that needs to be resolved, the
> consequences of this could be dramatic, and there is a role for the
> agencies to play in that public health aspect.
>
> I think the agencies agree with that. I think that what we need to do
> is to come out
>
> with\--there are a couple of things\--one, the agencies will review
> the transcript of this meeting, and not only those things that we
> point out especially need to be looked at, but all
>
> comments will be looked at for advice to them about what to do.
>
> What I would hope that we would come out of this with is not simply to
> repeat that\--Jean did and Dr. Aller did wonderful jobs in summarizing
> that, but I think that if we can come up with a short number of
> general recommendations, for example, that the agencies need to
> develop a much larger and much more effective research program on
> several areas in terms of concentration of methylmercury in fish and
> agreement on the speciation of fish, and so on, that is the kind of
> recommendation we need to make, and the fewer of those, the better,
> that are more likely to get attention.
>
> Dr. Downer.
>
> DR. DOWNER: I won\'t belabor the points that you have already made,
> because I think we all are in concurrence. I just wanted to bring a
> little bit of light onto some additional issues.
>
> Based on some of the data that we received today, it appears that some
> additional fish may be
>
> needed to be added to this list, albacore tuna for one and halibut.
> Those are at higher levels than we had, at least I had first thought.
>
> With respect to the portion sizes, USDA uses 3 ounces of the standard
> portion size, and perhaps when we talk about portion sizes, maybe that
> is what we would want to look at, 3 ounces rather than the 6 to 8
> ounces of whatever the nebulous number that we are actually using at
> this time.
>
> With respect also to providing information for the different groups, I
> think the physicians, clinicians, and other health care providers who
> provide information to John Public should have some material provided
> specifically for them, as well, so this can serve as a resource for
> the public, because that is important, as well.
>
> DR. MILLER: Thank you.
>
> Dr. Dwyer.
>
> DR. DWYER: Thank you, Dr. Miller.
>
> I am a little worried about the best being the enemy of the good or
> the better, and wanted to
>
> congratulate EPA and also FDA for what they have striven to do in the
> past year or two since we last saw this.
>
> It really has been an enormous effort and I think sometimes we get in
> to the niggling details without saying that this approach of modeling
> I think is a good one and the question is the model is always the
> issue, and I will come back to that in a moment.
>
> In terms of the draft that is now available, is that likely or could
> it be posted on the web for comment? I am sure the answer is no, but
> basically, that would be one of way of keeping this evolving process
> going forward.
>
> My other suggestions have to do with the\--
>
> DR. MILLER: Wait a minute, before we go any further, Johanna, I want
> to know if there is somebody here that can talk to that. David?
>
> DR. ACHESON: As a relative newcomer to the Federal Government, I would
> say anything is possible, but that is probably not realistic. I think
> if that is a recommendation, Dr. Dwyer, that
>
> you feel is important, we would certainly take it into consideration.
>
> I mean we are looking for comment. On the other hand, we don\'t want
> to take forever, because we believe we have an important public health
> goal.
>
> DR. DWYER: The reason I think it is important is this, that I think
> this is an improvement over what is up there now, and I have been
> developing, with many colleagues, advice for pregnant women, and kept
> telling people to go to the web to find what I thought was on the web
> from what we did two years ago, and nothing was there.
>
> So, at least from my standpoint, it is a recommendation, I don\'t know
> if the committee shares it, but basically, we have done a lot of work,
> all of us, and we are making progress. We don\'t have something that
> is perfect yet.
>
> DR. ACHESON: Just so I understand what you are recommending would be
> that the current draft advisory be posted for comment?
>
> DR. DWYER: I am. Even though I have told you many, many things I think
> is wrong with it, I
>
> think it is better than what the current advice is.
>
> DR. ACHESON: So, post it as a draft.
>
> DR. DWYER: Oh, absolutely.
>
> DR. ACHESON: As a draft for comment.
>
> DR. DWYER: As a work in progress, which is a little better than what
> is there now. That\'s all.
>
> DR. ACHESON: Okay.
>
> DR. DWYER: The second issues has to do with the table.
>
> DR. MILLER: Dr. Acheson, thank you.
>
> DR. DWYER: One has to do with this whole issue of nailing down
> consumption patterns of infrequently consumed foods that may be of a
> problematic nature or perhaps of an enormously beneficial nature, and
> that gets to these fishes.
>
> Again, I am delighted that you are thinking about doing, but I would
> recommend specifically that you try to get better estimates of
> consumption by continuing to refine the questions that are being asked
> in the HANES survey. As you know, HANES now is doing 5,000 people a
>
> year, so over time it really does develop into the kind of samples
> sizes where you can do cuts by three or four different things and get
> to specific subgroups, but it takes time.
>
> The items right now for foods that are not very frequently consumed
> are a problems. There are ways\--people at NCI have worked on this
> propensity questionnaire, which are lists where they get some idea of
> consumption over 30 days, that are more specific.
>
> Of course, we would have to have the common names, as well as the
> names that some of us don\'t, know for these fish that we are eating.
> So, I would urge that that be done. Maybe HANES isn\'t the best place
> to do it, maybe it\'s MRCA, maybe it\'s some other place, but the idea
> is to get better consumption data.
>
> Dr. Russell mentioned getting better data on the methylmercury in the
> fish because you need food, as well as consumption, to get food
> consumption. I would urge private sources, state sources, whatever
> sources\--food-composition
>
> analysis is very, very expensive, so if the data are out there and
> they are collected already, why go to doing the analyses yourselves.
>
> The third thing is blood levels and the variability in blood levels,
> so that diet can be related to blood levels, and that is one thing
> that HANES can do for you, and there may be some others, I don\'t
> know.
>
> Finally, continue to develop models and refine them, and specifically
> when people get into risk-risk, benefit-risk, whatever, we really do
> have to look at every assumption. We have to look at sensitivity
> analysis because each assumption can make an enormous difference in
> what is going on there.
>
> I know people know it, but I am just trying to get it into the record
> that any analysis needs to have all of those things.
>
> DR. MILLER: Dr. Krinsky.
>
> DR. KRINSKY: I used to get questions as an undergraduate, compare and
> contrast. Some of them, one could do that, but, you know, compare and
>
> contrast Chaucer and Saul Bellow is impossible. So I thought I would
> compare and contrast the 2 1/2 year old advisory to the present
> potential advisory.
>
> The 2 1/2 year old advisory has three points just as this one has. The
> first point is, to protect your unborn child, do not eat shark,
> swordfish, king mackerel, and tilefish is the same.
>
> The second point was, you can safely eat 12 ounces per week of cooked
> fish, and now the present one talks about 12 ounces of purchased fish.
> Now, we know that there is some difference between cooked and
> purchased, so whether that is an improvement or not, I am not clear at
> all.
>
> Also, the second point 2 1/2 years ago was that a typical serving of
> fish is 3 to 6 ounces, and now it\'s 3 to 4 ounces, so they have cut
> down the size of each serving.
>
> The third point was\--this is the old
>
> one\--there is no harm in eating more than 12 ounces of fish in one
> week as long as you don\'t do it on a regular basis, and the new one,
> I am sorry, I
>
> repeated that.
>
> The third one is check your local advisories. They had the same thing
> in both of them.
>
> So, in those three points, there has really been very little
> difference in the original FDA advisory and the present one, the joint
> EPA-FDA advisory. What has been added now is the tunafish, and I agree
> with Rob Russell that that is sort of ambiguous in terms of the
> quantities that are allowed.
>
> So, the changes, as far as I can make out, have not been large
> changes, and yet it has obviously caused us to have a full day of
> discussion. I think what is important to me is the information that
> appeared at the end of this morning\'s session from the public
> organizations.
>
> The one point that seems to stick with me is the 12 ounces of fish,
> cooked or not cooked, and whether, in fact, that is safe. I am not
> clear after listening to the presentations this morning that 12 ounces
> of any of the selection other than
>
> the 4 that are proscribed would be a safe level.
>
> So, I am very concerned about having that in the advisory as it is
> now.
>
> DR. MILLER: You mean the tunafish?
>
> DR. KRINSKY: Of any of the fish, because we did hear presentations
> indicating that 12 ounces of a variety of the fish that had been
> evaluated for their mercury content could regularly lead to levels of
> mercury consumption that would be above the RfD.
>
> DR. MILLER: The problem, just to raise the issue\--the problem is that
> there are some positive virtues of the consumption of fish that have
> to be taken into account, and that is part of, I think. the risk-risk
> analysis that needs to be done.
>
> Without that, I think the nature of the risk process allows you to do
> this if you recognize what the potential hazards are.
>
> Jean.
>
> MS. HALLORAN: If I could speak for myself now, instead of the group, I
> very much agree with
>
> what Dr. Krinsky just said, and what I think is important to realize
> is that the 12 ounce is\--from Carrington\'s analysis, the 12 ounce is
> okay if you are eating low mercury fish, but not if you are eating
> medium mercury fish.
>
> Now, I took a look at the low mercury list that he was working with
> and compared it to the fish that are consumed by the public, and if
> you take the top 10 fish that are being eaten by the public, they are
> all on the list of low mercury fish except for albacore tuna.
>
> So, you could easily construct an advisory, just change a few words in
> what has been written here, and significantly change the import of it.
> Instead of saying you can safely eat 12 ounces, say you can safely eat
> 12 ounces of low mercury fish, which include\--and then list the top
> 10 or even the top 5 - shrimp, salmon, pollock, catfish, cod, to take
> the top 5, and add shellfish, and you pretty much have it.
>
> I also really think as a committed fish eater, that there are
> tremendous advantages for
>
> eating fish, and people should not be discouraged from eating fish,
> but the only way, if you have a message that just says don\'t eat
> without a part of the message that says here are some you can eat,
> that you are going to discourage people.
>
> If you want to have a two-pronged message and make it clear that all
> fish are not the same for pregnant women, then, you have to have a
> positive list, as well. So, that would be my main recommendation, that
> in the advisory, that fish be named, the low mercury fish be named by
> name.
>
> Then, just a couple of other things. I agree that we could make a
> recommendation to have an example of body weight and serving size for
> a child, to make that clear. I don\'t think that is obvious to many
> consumers. It is too much arithmetic.
>
> Then, thirdly, where it talks about tuna, so you could safely include
> light tuna as part or weekly fish consumption, because that is what
> the science supports. Thanks.
>
> DR. MILLER: Dr. Durst?
>
> DR. DURST: I would like to get out of the chemistry path and comment
> on some of the information that these recommendations are based on,
> the analytical data. I am not sure how these data were evaluated,
> whether the literature values from various studies over the years were
> just accumulated and added together or whether there was actually a
> critical review performed on how these data were acquired in terms of
> the methodology used, the protocols, whether you are measuring total
> mercury, or methylmercury, or what species in particular.
>
> So there are a lot of possibilities for introducing a lot of the
> variability I think we see in the data that have been acquired over
> the years.
>
> I would like to suggest that if EPA or FDA sponsors any studies in the
> future as far as trying to apply these data for the advisory, that a
> strict protocol be provided to the contractors to follow so that we do
> know that we are measuring the same quantity and can have a little
> more validity to these data.
>
> Thank you.
>
> DR. MILLER: Any other comments? Dr. Waslien?
>
> DR. WASLIEN: I just made a list of what things one should look at. The
> list became long but I was concerned that on the RfD selection
> process, if that isn\'t also something that should be part of the
> ongoing research agenda, that one also makes sure that the NHANES data
> on blood levels be compared with risk of effects from it. If you are
> going to be doing a risk assessment and benefit assessment comparison,
> that should be part of the equation, too.
>
> DR. APOSHIAN: I remember that at the end or during the last meeting,
> it was suggested by a number of people that since the tunafish
> industry analyzes every batch of tuna that basically goes into a can
> for mercury, that the FDA might want to consider looking at that data.
> If the analysis has been done by an approved lab, under certain
> conditions, it would better than no data.
>
> I think it was the president of the Tuna
>
> Association that told me during the last meeting that they had this
> data, and I think he told me also they would be glad to share it. I
> don\'t know whether the FDA would want to depend on such data, but
> when you think about clinical trial of drugs, the FDA\'s drug approval
> group, whatever it is called, accepts data from the pharmaceutical
> companies if they have compiled the data and have done the analysis.
>
> So, there might be a bank or a reservoir of data that is available,
> and I would recommend that we ask the FDA to look into that. That is
> number one.
>
> Number two, I am just a poor country boy, I just teach and do a little
> research, but from what I know about industry, I think, is that if
> industry had this problem of coming out with an advisory, they would
> hire experts who know how to write advisories. They hire communication
> experts. The FDA, I know hires all sorts of consultants and contracts
> all sort of work and I wonder whether we could recommend that for the
> fish advisory, that
>
> they bring in some kind of outside expert to help them put together an
> advisory that might be more acceptable.
>
> Third, I am very concerned about the albacore tuna, and I hope
> that\--I know that maybe this may not be the time\--but I hope, Mr.
> Chairman, we will get back to the question about what do we do about
> albacore tuna.
>
> Thank you.
>
> DR. MILLER: Why don\'t we discuss albacore now if we are going to
> discuss it.
>
> DR. APOSHIAN: I didn\'t see anyone disagree about the analytical
> results as far as the amount of mercury in albacore tuna as compared
> with other fish. Again, I don\'t do shopping in my household unless my
> wife is sick. She had broken her ankle, so I stopped by the tuna shelf
> in the local market, and albacore, I saw it, because I was never aware
> of it before the last meeting. So I saw it and said, it doesn\'t even
> say tuna, it says albacore.
>
> You know, I am supposed to have a Ph.D.
>
> and M.S., and I didn\'t do know that, that albacore was tuna or is
> considered to be tuna. There seems to be some need, again, of
> educating the public about what albacore is. I do studies all over the
> world, and every time I see sick children who are exposed to arsenic
> and mercury, whatever, I feel very badly and can\'t help but relate
> them to my own personal background, namely, my grandchildren.
>
> I certainly, at the present time\--well, I have told my granddaughter
> who is of childbearing age, which I hope she won\'t have one for a
> long time, that she should be very, very careful about the tunafish
> that she eats, that she should probably have one sandwich a week,
> which is plenty, and I also told her just the other day when I was in
> Boston, that she shouldn\'t eat any albacore. But I have told her she
> should eat fish, and that fish is very, very good for her, and that
> message gets across.
>
> It gets across probably because I make a point of it, and so I am
> asking whether the FDA could make a point of getting experts to get
> that
>
> message across, because I certainly would hate to think\--I don\'t
> like the idea of American children or American pregnant women or women
> of childbearing age eating a lot of albacore. I think that should be a
> very important part of this discussion.
>
> I know we are going to have to make compromises on tunafish and other
> things, but the albacore seems to me\--as a toxicologist, seems to me
> to be a potential source of danger, but there are nutritionists here
> who can talk more about that.
>
> DR. MILLER: Jean.
>
> MS. HALLORAN: This also raises the question of what should be on the
> Do Not Eat list, and there doesn\'t seem to be a firm criteria for how
> something gets on that list or possibly gets taken off it. I think
> that we have seen from
>
> the\--if we can ever figure out what tilefish was, we might be able to
> determine that with new data, perhaps it doesn\'t have as much mercury
> as was initially thought or perhaps there is some subspecies of it
> that does and that subspecies or a
>
> particular local variety could be identified.
>
> On the other hand, we have pretty much confirmed that albacore tuna is
> high and grouper and orange roughy aren\'t looking very good. They
> appear to be higher than the tilefish.
>
> So, perhaps a recommendation could be to FDA to establish a criteria
> or cutoff for what goes on the Do Not Eat list and to revise that list
> periodically as data comes in with serious consideration as to whether
> albacore tuna should be on the list.
>
> DR. MILLER: Well, that would apply also to the moderate levels, as
> well. In other words, if you are going to make a list, you need to
> have criteria to decide on which of those lists things go. It is not
> just the high-dose fish that we have to worry about. We have to worry
> about the fish with moderate doses, as well, too, the ones that you
> are effectively saying you can eat it, but don\'t eat it too
> frequently.
>
> MS. HALLORAN: Although at the moment, I don\'t believe that exists as
> a public list, does
>
> it, the middle list?
>
> DR. MILLER: It is not in the advisory. The advisory just has the
> Don\'t Eat part of the list.
>
> DR. ACHESON: The high, medium, low criteria were in the directions to
> the peer-review group.
>
> MS. HALLORAN: My understanding is that there is data that say high,
> medium, low, but I don\'t recall FDA giving any instructions on how
> much you should eat from the medium and low groups.
>
> DR. MILLER: David.
>
> DR. ACHESON: Yes, just to clarify that point, the data is on the
> website. The high, medium, and low, for the purpose of the exposure
> assessment, as Dr. Carrington mentioned yesterday, were arbitrarily
> chosen to put light tuna in the low category. So essentially, the 0.12
> was the cutoff for that, and everything below went low, and everything
> above went medium except for the 3 high, in fact, because he didn\'t
> use tile fish in the model.
>
> DR. DICKINSON: This is just to reiterate the point that was already
> made about the need to clarify the reasons for classifying things in
> different places, because if we are talking about adding albacore tuna
> to the list of Don\'t Eat things, it actually, on their list, is not
> at the top of the middle mercury category, and is not that much above
> the couple that are just below that.
>
> So, I think there would need to be a reason for selecting the cutoff,
> and some uniformity about what was on the list.
>
> DR. APOSHIAN: It might be the idea of consumption, that they probably
> eat more of that than some of them above.
>
> DR. DICKINSON: That may be true, but we don\'t have very satisfactory
> data from NHANES as to whether tuna was figured largely in the
> individuals who were at the top of that distribution either.
>
> DR. DWYER: Do we know that? Do we know what that top 5 percent ate?
>
> DR. DICKINSON: No.
>
> DR. DWYER: It wasn\'t in HANES anyway, was
>
> it?
>
> DR. DICKINSON: Yes, it was, the 8 percent was.
>
> DR. ACHESON: That was part of the problem is that we really don\'t
> know what those 8 percent ate, which is what I said earlier this
> morning, that that is part of the goal is to figure out who they are
> and what they eat, so we can develop a targeted message toward them.
>
> DR. DICKINSON: But we don\'t have information now to say it\'s tuna.
>
> DR. ACHESON: No, we do not.
>
> May I just make one other comment in relation to that, and that is, in
> terms of the exposure through market share versus the amount an
> individual consumes, because obviously, the critical issue is how much
> is on your plate.
>
> We know that a portion of albacore may be no different from a portion
> of salmon. The critical issue would be, as we know from the data, that
> there is a lot more albacore consumed, and tuna consumed, than there
> is salmon. So I think
>
> that if we are going to try to set criteria for high and medium, we
> have got to define that very carefully.
>
> DR. MILLER: That is reasonable. That doesn\'t necessarily take away
> from the fact that this could be very useful.
>
> DR. ACHESON: I agree, it could be useful if it could be done, yes.
>
> DR. MILLER: Dr. Aller.
>
> DR. ALLER: I think that point gets back again to our definitional
> issue of what do we mean by high, are we talking about high risk, are
> we talking about high concentrations, and when I talk about risk, I am
> thinking not only of concentration but frequency of consumption.
>
> I think as we talk amongst ourselves, we need to be keeping that clear
> in what we mean and in our advice back to FDA and EPA.
>
> DR. MILLER: Dr. Callery.
>
> DR. CALLERY: Thank you. I think we have often now looked to a
> scientific basis for what we are making our decisions on here, and it
> looks like
>
> we are not having a good definition of what makes the list and what
> doesn\'t make the list, and where it fits on the list.
>
> I think that that becomes even more difficult in the process of saying
> what is the criterion for putting an item on the list for the advisory
> or off the list for the advisory.
>
> I think there is a negative impact to the public to change your mind
> after a while, and you ought to have a very good criteria set up to do
> that. I know, at least in my neighborhood, there is a distrust of
> scientific information. The concern is, you told me I could eat it,
> and now you tell me I can\'t. Can\'t you make up your mind?
>
> So, I think to do that kind of idea of saying you can take it off the
> list at some other point, you had better have a really good rationale
> and criteria established ahead of time rather than you will figure it
> out later.
>
> The issue about albacore, of putting it on the list of banned ones
> would be I think a very confusing thing for the public because some
> people
>
> think of tuna as tuna, and I that it would be difficult to say, well,
> this one type of tuna is banned, but this other type is just fine, and
> then the idea that, in fact, in a few months you might decide that, in
> fact, it went down from 0.3 something to 0.29 and you took it off the
> list, would cause a lot of trouble.
>
> I think the issue here is, I would not recommend that we put the
> albacore on the banned list. I think we need to address the fact that
> it is a very popular fish and we should do the benefit-risk analysis
> to determine with this important food, where it fits into the scheme.
>
> DR. MILLER: Dr. Dwyer.
>
> DR. DWYER: Well, the good things is there is no chronic wasting
> disease of tunafish, but I think there is a way to get around this.
> The advisory for the consumers? Who knows? But I think there is a
> little algorithm that could be used if we could just come up with what
> is medium.
>
> You know, are you pregnant, at risk, nursing; if yes, then, the
> question is do you eat
>
> shark, swordfish, king mackerel or tile fish, using the common names,
> and if the answer is yes, then, stop it, and if no, do you eat over 6
> ounces per week of game or sport-caught fish, and if yes, then, watch
> not to eat more or check your local advisory.
>
> If no, then, you never eat any of those, then, we get to the issue of
> trying to make it a positive message for consumers, and the question
> becomes what the recommendation is for low mercury fish. Doug pointed
> out there really isn\'t any if we are talking below 0.1, right?
>
> DR. HEIMBURGER: Or at least no upper limit for low mercury fish.
>
> DR. DWYER: You can eat as much as you want.
>
> DR. HEIMBURGER: With the exception of body weight.
>
> DR. DWYER: Or 12 ounces.
>
> MS. HALLORAN: What did you mean when you said there isn\'t any\--
>
> DR. DWYER: That you could eat a lot of it
>
> without\--
>
> DR. HEIMBURGER: Even 12 ounces shouldn\'t necessarily be considered a
> limit for low mercury fish in non-pregnant people who don\'t eat game
> or sport-caught fish.
>
> MS. HALLORAN: In non-pregnant people.
>
> DR. HEIMBURGER: Right, non-pregnant.
>
> MS. HALLORAN: In pregnant people, it should.
>
> DR. DWYER: There would still be a limit of 12.
>
> MS. HALLORAN: I believe so.
>
> DR. HEIMBURGER: Oh, I am, it is in pregnant people.
>
> DR. DWYER: It is only in pregnant. Then, the only one I can\'t fill
> out on this would be, no more than 6 ounces per week of the medium
> mercury fish, and 12 ounces would be the limit for the\--
>
> DR. HEIMBURGER: Why should there be a
>
> 12-ounce limit for the low mercury fish in pregnant women?
>
> MS. HALLORAN: Because they all have
>
> mercury.
>
> DR. HEIMBURGER: But if they are low\--
>
> MS. HALLORAN: Not that low.
>
> DR. HEIMBURGER: Some are, some are nondetectable.
>
> MS. HALLORAN: No.
>
> DR. MILLER: Well, this isn\'t getting us very far.
>
> DR. DWYER: Thank you, Dr. Miller. It strikes me that it does. You have
> got light tuna over in the 12-ounce side, and you have got the
> albacore in the 6-ounce side, and I think it does get you someplace.
> And no chronic wasting disease.
>
> DR. MILLER: Well, this issue concerning albacore, that was the
> question that was being asked, rather than the other fish. It seems to
> me, having been raised, that question needs to be\--we need to come to
> some recommendation or else we could say we can\'t make a
> recommendation because we don\'t have the data to support a
> recommendation.
>
> Even if we said that, it seems to me that what we need to do is to
> recommend that an analysis
>
> of albacore tuna be a priority issue and whatever research activity
> that FDA and EPA take on.
>
> DR. APOSHIAN: But I thought we had the analysis.
>
> MS. HALLORAN: There is plenty of data.
>
> DR. APOSHIAN: I think there is plenty of data about albacore. The
> question is what are we going to do about it, are we going to accept
> that data, are we going to move ahead with it, or are we going to keep
> talking about it.
>
> DR. LUND: You still get back to the question, though, of what is the
> net ingestion, not the parts per million in the fish, and if you look
> at the data on page 13 of their table under Tab 8, Table 2, you look
> at albacore versus the light canned tuna, the albacore is 3 times
> higher\--
>
> DR. DWYER: We are having trouble. What are you\--
>
> DR. LUND: Tab 8 is the paper by Carrington and Bolger. If you look on
> page 13, there is a table, and that is the one that I think some of
> our colleagues from FDA have referred to,
>
> to say, look, there is a lot of data out there. The data we showed you
> in this little special table only happened to compare old data with
> new data.
>
> So, if you look at line 6, the albacore canned tuna is approximately 3
> times higher in concentration, parts per million, measured as
> mercury\--not methylmercury, but measured as mercury, I presume\--and
> its disappearance, its market share, however, is approximately a
> third.
>
> So, from an impact level, if the market share data reflect what
> happens across the population, then, the exposure of the population to
> methylmercury through tuna, either albacore or light tuna, is the same
> approximately.
>
> DR. APOSHIAN: But not the exposure to the individual.
>
> DR. LUND: That\'s to the whole population, that\'s correct.
>
> So, the question comes back again to what is the actual consumption of
> tuna by pregnant women, women nursing, or women likely to become
> pregnant. The answer is we don\'t know. So why
>
> would we suggest banning something because, at this point, the data
> are incomplete? What happens if you came back with a result, and you
> went into the NHANES data or you went into some other method of
> getting those data, and you found out, in fact, that they don\'t eat a
> lot of albacore tuna. Now, would you have to come back and change your
> advisory and say whoops, we made a mistake because now we have more
> complete data. We now have more complete data, so we are going to
> change the recommendation again.
>
> DR. APOSHIAN: You are talking about banning.
>
> DR. LUND: I didn\'t mean banning.
>
> DR. APOSHIAN: Well, whatever you are saying.
>
> DR. LUND: No; I meant to put it into a Don\'t Consume category.
>
> DR. APOSHIAN: Again, I am not talking about a Don\'t Consume. What I
> am talking about is in the prior advisory, no mention was made of tuna
> as far as a word of caution is concerned, and what
>
> I am suggesting is that some kind of statement be made that albacore
> should be eaten under certain restrictions or limitations. I am not
> saying it should be banned. A pregnant woman should be warned that
> albacore has more mercury in it than light tuna, or lower than
> whatever the common fish is.
>
> DR. LUND: That is number two in the advisory.
>
> DR. APOSHIAN: Pardon?
>
> DR. LUND: That is directly addressed in the advisory.
>
> DR. APOSHIAN: But it wasn\'t in the old advisory.
>
> DR. LUND: No; but the new advisory.
>
> DR. MILLER: With regard to the new advisory.
>
> DR. APOSHIAN: So, what I am asking, there is no question\--
>
> DR. LUND: But I thought we were discussing whether albacore should be
> put into that category with swordfish, et cetera. That is what I
>
> thought you were getting at.
>
> DR. APOSHIAN: I gave that up a long time ago, knowing the feelings of
> this committee. What I am asking for is a word of caution of some kind
> about albacore itself. I don\'t have the thing in front of me, so, if
> it says albacore, fine, that is certainly a major step forward from
> the last, old advisory.
>
> DR. MILLER: Dr. Scherer, did you have a comment you wanted to make?
>
> DR. SCHERER: My comment is based on the one that we discussed earlier,
> about the recommendations over time. That clearly is as problem and
> one that I think all of science faces. It seems to me that any
> advisory that goes out needs to have some level of small disclaimer
> saying, based on what we know today.
>
> For me, that is beginning to try to educate the American public that
> science, by its very nature, changes and we want that to happen rather
> than coming out with authoritative statements that this is the way it
> is, and then in
>
> the future, we change it, and, in fact, do confuse people. So I think
> any advisory needs to begin trying to put a context on it based on
> what we know today.
>
> DR. APOSHIAN: As a point of clarification, since no one brought it up,
> saying it\'s not in the new advisory, under, \"To protect your baby,
> follow these three rules,\" and I don\'t see tuna or albacore
> mentioned anywhere in those three rules.
>
> Later on, if you get to it, frequently asked questions about mercury
> and fish, under No. 2, what is tuna? It says that tuna steaks
> generally contain higher levels of mercury than canned tuna. Now, I am
> not even sure I see the word albacore in there\--yes, I guess it is. I
> am sorry\--tuna steaks and canned albacore. But it certainly does not
> say, to protect your baby, don\'t eat a can, or 5 cans of albacore a
> week. I would like to have a word of caution in there.
>
> No one I think believes that they can ban the canning and selling of
> albacore tuna, but I
>
> thought our role as an advisory committee was to advise the FDA from
> the knowledge that we may or may not have as far as the public health
> is concerned, and I would certainly\--knowing the pregnant women that
> I know, young ones, I would certainly like them to know that albacore
> should be of concern to them, and this doesn\'t do it at all as far as
> how to protect your baby.
>
> DR. DICKINSON: I think in response to that comment and many others
> that have come up, that Johanna had a very good idea just a moment
> ago, which is what is really hanging us up and what was commented on
> by many of the speakers today, is the idea that you can eat up to 12
> ounces of anything other than these four, and that appears not to be
> the case.
>
> So, Johanna\'s idea of having a category of which you would have a
> limit of 6 ounces of the medium level fish, and then another category
> of the low mercury fish for which you could go up to 12, I think makes
> a lot of sense.
>
> I don\'t see a justification except in
>
> share of the market, and I accept that that is something that needs to
> be considered, but I don\'t see a justification for culling albacore
> out uniquely, out of that middle category.
>
> DR. APOSHIAN: As long as we have three categories, which we don\'t
> have at the present time, as long as we have that.
>
> DR. MILLER: Did you have a comment, Jean?
>
> MS. HALLORAN: I agree with what was just said. I agree that three
> categories would solve the problem, and the statement about tuna, I am
> particularly concerned about the last sentence, that says, \"You can
> safely include tuna as part of your weekly fish consumption,\" without
> specifying that truly, the only kind of tuna that you can include is
> light tuna.
>
> DR. DICKINSON: Or a lesser amount of albacore.
>
> MS. HALLORAN: Or a smaller amounts of albacore, right.
>
> DR. MILLER: Dr. Aller?
>
> DR. ALLER: No; Thank you. I think the
>
> points have just been made.
>
> DR. MILLER: Dr. Downer?
>
> DR. DOWNER: I am going to talk from the public\'s perception, John Q.
> Public, the consumer.
>
> I would suggest that we ought to think about is portion size. The
> other thing that I think this committee may want to think about is, is
> there a group that we can classify, a group of fishes that you can eat
> any amount of, that there is no limit.
>
> That is the group I am interested in, which means the group that can
> eat as much as I want. That is the group I want us to talk about if we
> get a chance.
>
> DR. HEIMBURGER: That will address the high-end users.
>
> DR. DOWNER: I am interested in high end and low end, just tell me that
> you can eat as much of this as you want, that is all I am interested
> in.
>
> DR. HEIMBURGER: But it would avoid alarming high-end users that they
> need to drastically reduce their intake of seafood.
>
> DR. DOWNER: I\'m sorry; I didn\'t get you. What did you say?
>
> DR. HEIMBURGER: If you were to give a category within which you could
> eat as much as you wanted, then, you would avoid alarming people who
> are already high-end consumers of fish.
>
> DR. DOWNER: That\'s right, but also for those who are interested in
> eating fish, this is another way to say, enjoy it, all of these kinds
> of things. Is the such a group?
>
> DR. HEIMBURGER: But is it possible to create such a category even
> for\--that are low enough to allow that statement.
>
> DR. MILLER: Jean?
>
> MS. HALLORAN: I think the best clue on that is if you look again at
> this Table 2 that was just referred to, I think you would have to
> probably stick to like the bottom 3 or 4 items on the list. It would
> be a very small list. Sardines? Pregnant women like strange things.
>
> DR. HEIMBURGER: Would you want to extend it up as far as salmon and
> which would include
>
> shrimp. That is the most consumed populationwise.
>
> MS. HALLORAN: We need someone to do the calculations on that for us.
>
> DR. MILLER: Why can\'t we make a recommendation\--let me put it this
> way\--we have come close to the time when we have got to come up with
> some of these recommendations, and certainly one of the
> recommendations ought to deal with the format. Much of what we are
> talking about are format issues, and among them is the development of
> the three lists indicating the concentration of mercury.
>
> Another thing might be the indication on those list which are the
> ones\--well, let me go back a bit. Another thing is that we have got
> to recommend that the advisory be more positive in many ways. It is
> very negative in many areas. We could indicate a group of fish in the
> lowest concentration area can be consumed. That is the kind of
> recommendation I think we are going to have to make.
>
> We are also, I think, going to have a
>
> research recommendation. One of the things we ought to be saying in
> that research recommendation is this is an important enough issue to
> be a very high priority to the agency. That means that they ought to
> be spending more money on this issue than they have been spending.
>
> Among these, also in terms of research, we ought to reemphasize the
> importance of trying to develop a collaboration with the industry, who
> I am sure have data, and there are ways of developing this data which
> would not pose difficulty with the companies that are providing that
> data, like what the agent is with lead in condensed milk. That was a
> very successful program to reduce lead in condensed milk.  These were
> data that were collected by NSDA who acted as a broker in making sure
> that FDA\--the data was not used for any regulatory purposes.
>
> There ways of doing this.
>
> But those are the kind of recommendations, and it seems to me that the
> issue of the albacore thing, it can be at least partially resolved by
>
> having three lists, one of which, the moderate one, is fish to be
> consumed in restricted consumption of fish.
>
> Dr. Krinsky.
>
> DR. KRINSKY: Thank you. Referring back to this Table 2 in the draft
> document of December 24th, 2003, the right-hand column has three
> categories, high, middle, and low. The title of that column is
> Advisory Group. Was this decided on at the last meeting of this
> advisory group? What is the basis for this?
>
> DR. MILLER: I have no idea. David, can you clarify it for us?
>
> DR. ACHESON: Yes, I will try to. That was the arbitrary exposure
> assessment along with the definition of high, medium, and low. The low
> was modeled around the light tuna, taking that as that, and the low,
> would be low.
>
> DR. KRINSKY: Then, would it be possible for the recommendation to say
> no fish consumption in the high group\--this is for the pregnant\--no
> fish consumption in the high group, maybe 1 fish
>
> consumption for the serving that is from the middle group, and I
> don\'t know how much from the low group. Would that then become
> unlimited from the low group? Somebody would have to go through the
> calculations to figure out how much that that group could consume.
>
> I am also not sure whether the arbitrary high grouping is really
> appropriate, because it seems to me the grouper and orange roughy are
> really quite high.
>
> DR. MILLER: I think if we recommend that they establish these three
> groups and the subsequent criteria for them, you would have to look at
> the entire listing of issues when we develop those pages.
>
> DR. KRINSKY: Well, they would only have to look at the fish for which
> there is data, though.
>
> DR. MILLER: Yes; that\'s all they can do.
>
> DR. KRINSKY: I assume that that is what this table is. Were there fish
> that were not included in this table?
>
> DR. ACHESON: I think essentially, no. Tilefish, frozen tilefish, as we
> discussed, they are not in there.
>
> DR. MILLER: Dr. Aller?
>
> DR. ALLER: I would also just to make another point. Getting back to
> the point you raised about collaboration with industry, there are also
> state laboratories that are out doing NRs. We do mercury analyses on a
> regular basis and would be very happy to\--and, I believe have
> provided, whether or not they have been used in any of these risk
> assessments. But we have those data, and share methodologies, et
> cetera, and I know that has been an ongoing difficulty for FDA over a
> number of years. I really think we need to get it, not just for the
> safety, but for so many more\--we need to get to the point where FDA
> can accept other data.
>
> DR. APOSHIAN: Not as a written recommendation, but could we sort of
> ask the FDA and the EPA people that, when they give us a chart like
> this, they sort of give us a range of standard
>
> errors, some idea as to what the figure means, because, you know, for
> a graduate student to give me this kind of data, it just would be
> absolutely unacceptable without some range or statistical analysis.
>
> DR. CALLERY: I have a suggestion for something that might be added as
> a recommendation that came out of the discussions of the last couple
> of days was the use of website information on an advisory, the
> recommendation that the website for further information be listed on
> the advisory.
>
> DR. MILLER: Dr. Heimburger?
>
> DR. HEIMBURGER: Just back to the question of whether there are three
> groups and whether there will be an unlimited group, could we at least
> recommend that they consider the establishment of a fourth group,
> which may be just called \"very low,\" from which it might be possible
> to consider not placing a limit on consumption?
>
> Just end it looking at criteria and deciding where the cutoffs will be
> between high and medium, medium and low, to consider a third cutoff
>
> for a fourth category of very low.
>
> DR. MILLER: We can do anything. We can make any recommendation we
> want. It is up to the agencies to implement it.
>
> DR. HEIMBURGER: Right. I am just suggesting\--
>
> DR. MILLER: Given the fact that among the most common recommendations
> that were made in various presentations was to develop a simple
> approach to the problem, so that anybody could understand it, it seems
> to me we are going in the opposite direction.
>
> We are making things more complex, not that we don\'t have to. As long
> as we couch these recommendations in terms of to have the agency
> consider these things, because something has to give sooner or later,
> particularly as we develop and build more into these things.
>
> When I think, for example, we haven\'t discussed at all, and I would
> suggest that we do, that we really consider the possibility of having
> multiple advisories for different population
>
> groups. It simply makes sense to do that.
>
> Having said that, that just makes it more complicated. But there is
> plenty of experience of doing that. Every dentist\'s office has a
> pamphlet in it that tells different groups of people what to do about
> their problems with their teeth. Well, we are worrying about mercury,
> not teeth\--maybe we are worried about teeth, I don\'t know.
>
> DR. HEIMBURGER: The amalgams are in there.
>
> DR. MILLER: Johanna?
>
> DR. DWYER: I think that is a good idea, and I certainly don\'t want to
> quote Vladimir Lenin in a government advisory group, but I will.
> Remember he said, \"First, socialism in one country,\" and first, we
> need an advisory, one advisory, and then we can get to these multiples
> ones.
>
> It seems to me one thing that might help clarify, back to Dr. Aller\'s
> issue, is that the very low fish are fine if we know the frequency of
> consumption, we have some kind of population-based
>
> data where we know frequency of consumption. Yes; there will always be
> demand for the lady, like the case in the New England Journal where
> the man ate 40 eggs a day. Then your bets are all off. The basic point
> is if most people don\'t eat very much of very low ones, maybe that is
> the way.
>
> DR. HEIMBURGER: Salmon and shrimp are there. Shrimp is at the very
> top, the number-one one, it could be in that group, and salmon is not
> far behind.
>
> DR. DWYER: If that is what market-share means. Is that what
> market-share means?
>
> MS. HALLORAN: It is per capita. They are ranked by pounds per capita.
> Shrimp is number one. Tuna is number two, and salmon is number three.
>
> DR. DWYER: I am sorry, so it\'s disappearance data, or is it
> consumption data? Do people eat it or is it what was on the market?
> It\'s disappearance data. So, those data are, with all due respect, if
> it\'s disappearance data, those data are probably higher amounts of
> mercury than the actual amount eaten, right?
>
> DR. HEIMBURGER: It\'s just market-share. Is some of the market-share
> going to our cats?
>
> DR. DWYER: There is always waste. There is always waste between what
> is on the market and what you eat.
>
> DR. CARRINGTON: It is supposed to be market-share. I don\'t know how
> well they do it. Those aren\'t my estimates, so I can\'t tell you
> exactly how they are done, But they are supposed to be human use, so
> it should not include pet food.
>
> DR. MILLER: Somebody handed me a list here of fish that would meet the
> standard of being able to consume as much as you want. They are very
> low levels.
>
> DR. CARRINGTON: Well, I can volunteer to do another simulation. I can
> add another simulation to my series. I can do a no high, low only, and
> then I can do a very low only. I guess the question is where do I pick
> my cutoff, and I guess I heard salmon. I guess I can take sardines as
> another one. I can do very low, and very, very low.
>
> DR. HEIMBURGER: A level of 0.03, according to Table 2, though, there
> is a bit of a gap that the 0.03 might fit into without coming close to
> any high consumption fish that are just over that level.
>
> DR. MILLER: Well, I don\'t think we ought to spend too much time or
> any more time. We are trying to work out what we want the agency to do
> in the first place, and we don\'t have the time nor the data to be
> able to do that, but at least we can make a recommendation to the
> effect that the agency should consider establishing a very low level
> for the purposes of determining those fish species that can be
> consumed in reasonable amounts. But I want to say, as much as you
> want, that always gets you in trouble.
>
> DR. HEIMBURGER: You get into the obesity issue. The language would
> have to be chosen carefully.
>
> DR. BUSTA: Earlier, Dr. Halloran indicated that if one made a
> modification to the current advisory, and included, in addition to the
>
> top 3, we have 4 there and the tilefish could exclude the golden
> tilefish, which comes in as a low one, probably is a different
> species, and if one added grouper, orange roughy, and albacore, one
> would have a top 7 to exclude for this group, and then name the bottom
> 10\--I wouldn\'t even limit it to 5\--I would name the bottom 10
> including light tuna as to what you shouldn\'t do and what you should
> do.
>
> That seems to me to get us off the dead center. Now, If you want to
> add this group of reasonable unlimited, and the others 12 ounces, but
> to me, that seems to give names, and if somebody is eating fish
> sticks, they have got to just roll the dice.
>
> DR. MILLER: What is in fish sticks?
>
> DR. BUSTA: I don\'t know what is in fish sticks.
>
> DR. DOWNER: Bread.
>
> DR. APOSHIAN: Whatever is cheap.
>
> DR. DOWNER: Mostly bread.
>
> DR. APOSHIAN: Are we recommending three
>
> separate advisories or are we recommending more than one advisory?
>
> DR. MILLER: I would think we are recommending more than one advisory.
>
> DR. APOSHIAN: We are. Good. Thank you.
>
> DR. MILLER: That is the idea, that there would be more than one
> advisory designed to be aimed at a specific population.
>
> DR. DWYER: And what are these different advisories for, for whom?
>
> DR. MILLER: Different populations.
>
> DR. DWYER: What different populations, women who are pregnant?
>
> DR. MILLER: I am sure a male, for example, could certainly eat more,
> and should eat more, fish, and we don\'t have to worry as much for
> them.
>
> DR. DWYER: I don\'t see why you can\'t have an algorithm that deals
> with all of them, and then develop the communications tools, which I
> certainly am not competent to do, and I might add that there are many
> others who are not competent to do, and
>
> leave it at that. I mean our expertise is not communications.
>
> DR. MILLER: What we are looking for is a simple way of dealing with
> this, at least I think that is what we are looking for.
>
> DR. DWYER: Right.
>
> DR. MILLER: And if you try to put everything into the same mode, you
> end up with a tree that doesn\'t necessarily prune very well.
>
> DR. DWYER: I don\'t think you do. I think you end up with an algorithm
> like that sheet that I proposed.
>
> DR. MILLER: I was going to say that this is one more approach to the
> problem. This isn\'t the only approach to the problem. To ask people
> to sit down and fill out a form to decide how much fish they are going
> to eat is a bit much.
>
> What I would say is, what I would like to do is include this in the
> record as an approach that the agency might choose to select. I have
> my own problems with algorithms like this.
>
> Dr. Russell.
>
> DR. RUSSELL: I actually agree with Dr. Dwyer. I think that to have one
> advisory is what we need, and then to have different communication
> tools to be targeted to parents of young children, to professionals,
> and to other groups, I don\'t know. I don\'t know whether Asians would
> need a different advisory or not\--a different educational tool or
> not, but I do believe that one advisory is really what we want to lean
> toward, and that would be the simplest, most clear message to the
> population in general.
>
> DR. MILLER: David, did you want to make a comment?
>
> DR. ACHESON: Yes. Thank you, Dr. Miller. We were just having a brief
> discussion of some of the complexities that would be involved in
> developing multiple advisories, and also the complexities involved in
> trying to define high, medium, and low.
>
> Certainly, it is obviously the committee\'s prerogative to say that is
> our problem to deal with, but I fear that if we were to set a divide,
>
> criteria that was specific for high, medium, and low, particularly
> medium/low, obviously, there is a big issue whether a fish jumps from
> medium to low, and if there is going to be a defined point, and we are
> going to continue to test. I have already said that, and you are
> certainly recommending that we continue to do that.
>
> I worry that we would have another tilefish example where we thought
> some something was high, and whoops, you know, goldface tilefish or
> golden tilefish are low, maybe we need more data.
>
> I am just concerned that we are going to get, as you pointed out, Dr.
> Miller, increasing complexity and increasing concern about that, and I
> really just wanted to make that point, that the science may be some
> good ideas, but it is certainly, in terms of trying to translate this
> into a simple message, going to be difficult.
>
> DR. MILLER: Without debating the issue, it seems to me that what
> should be done is to try it, in other words, as far as the different
> groups
>
> are concerned, the data would have to be worked out, and the endpoint
> would be what would be the exposure, based on your exposure
> information.
>
> I think as far as the multiple advisories are concerned, again, the
> question is how different would these advisories be.
>
> DR. ACHESON: Well, we would have to look into that. I mean again it
> would be nice to have a recommendation as to\--if we are doing
> multiple advisories, do we break out young children from pregnant
> women and women who may become pregnant? That wasn\'t clear to me from
> the discussion.
>
> Obviously, adult males are a different category, sure. But if we are
> going to go down the road of multiple advisories, just exactly what
> would the recommendation be of what they should be would be helpful,
> and what would come first, what is the most important one to tackle
> first and get that out.
>
> DR. MILLER: I think an answer, to start on the second. My own
> recommendation would be pregnant women or women who might become
> pregnant.
>
> Dr. Scherer.
>
> DR. SCHERER: I had a couple of points. It seems to me that the issue
> is not multiple advisories as much as it is putting it in a format
> that is better understood by the multiple audiences, so that the idea
> is to identify those target audiences that are at the highest risk,
> take this common advisory that everyone has agreed upon, and make sure
> it is in a format so that they understand that, that content.
>
> So, it might be a general advisory that is available to the public but
> targeted to make sure that pregnant women understand the importance of
> the parts for them. So, it is more of a design issue as opposed to
> changing the content of it.
>
> I had one other thought in terms of a recommendation related to this.
> It seems to me that once the tinkering with the content of the
> advisory and getting it to a point where it seems to be appropriate, I
> think the next step really needs to be, in terms of a recommendation
> from this committee, that it then be taken to audiences again
>
> to understand what is it that they remembering from it and what is it
> that they translate into the behavior, so they have a better
> understanding of those audiences before it really is distributed
> widely.
>
> DR. MILLER: One of the thoughts of our charge was to agree, or
> disagree, for the development of an outreach and educational program
> for these things. Do I take it, given the nature of our discussion
> here that the committee agrees with that, that the agencies ought to
> develop those programs?
>
> DR. HEIMBURGER: Yes.
>
> DR. DWYER: I have to say I think those are wonderful ideas, but first,
> we have to find out what is in the fish, and how many fish that people
> are eating.
>
> DR. MILLER: Well, that is the other question. The other question is
> shall we tell the agency to delay in releasing an advisory at all
> until all this data is together or do we suggest that they go ahead
> with the changes that have been
>
> suggested, and that further testing needs to be done, but go ahead
> with the idea that they are going to put it out and have to change it
> later on when new data comes on.
>
> That is the balance that we are running into here. This could be
> taking several years.
>
> DR. HEIMBURGER: Could we come up with a very short list of things that
> we think ought to be considered for very, almost, you know, for
> accelerated implementation, but just very minor things, and rest
> should wait until more data are available?
>
> DR. LUND: I actually thought that is where we were going. I thought
> that EPA and FDA were charged to look at a specific advisory to a
> specific subgroup of our population; pregnant women, women nursing,
> and women that may be about to become pregnant, or wanting to become
> pregnant or something, but in any event, that these special subgroups
> and small children, and babies, and they were to look at those
> advisories from those two regulatory agencies and come to a common
>
> understanding of what the advice should be.
>
> I haven\'t heard anything that suggests that they should not continue
> to do that. What I have heard around the table that there are some
> things in here that we think need to really be examined, and that is,
> the issue of meal size or the portion size, the issue of naming
> specific species and making sure people understand what they are,
> making sure it is absolutely clear that there is a strong, positive
> message in here, it is not just a negative message first, et cetera.
>
> So, I think our recommendation is to proceed in going through this
> process based on what you have heard here, coming out of the comments
> of the various members of the Advisory Committee, and continue to
> work, however, on the database both with regard to populations and
> what they eat, what the distribution of the consumption is of fish and
> fish products, and with regard to the database for the levels of
> methylmercury in fish.
>
> That is where I thought we were coming out at.
>
> DR. ACHOLONU: I thought that somebody suggested that we prepare this
> and put in on the website as a draft and leave it there with the
> understanding that it may be undergoing some changes as permission
> becomes available. I thought a suggestion was made that we put this on
> the website.
>
> DR. MILLER: The suggestion was made to put it on the website, but it
> doesn\'t indicate necessarily how long the agency will have to wait. I
> mean what is concerning me is that we can continue to increase the
> amount of data that we think we need in order to deal with this.
>
> The question is at what point do we say that can continue, but we have
> got to get on with the process of coming out with an advisory of some
> kind, and you just keep making the risks bigger and bigger and bigger.
>
> DR. ACHOLONU: If we indicate that, as of now, there is going to be
> information available, because things change, and the list that we
> have, the high, the medium, and the low, there is a
>
> possibility that they can change with time.
>
> DR. MILLER: I agree.
>
> DR. ACHOLONU: So, we may not come up with something that is finite at
> this time, but there should be something that people can use as
> guideline at the present moment, just indicate that it is not final
> and that as new information becomes available, it will be updated.
>
> DR. MILLER: Well, several members of the group are going to be leaving
> in the next 15 to 30 minutes, so we need to come to a conclusion. I
> can one make recommendation to facilitate this.
>
> When the transcript is available, we can go through the transcripts
> and try to make a list of the recommendations that we made, and we
> will share it with the committee for their comments. Let\'s try and
> focus on the most important issues rather than every one of them.
>
> DR. WASLIEN: If we did it as individuals and voted on which ones we
> thought were first priority, second priority, you know, when we get it
> back. Then you can get a democratic process.
>
> That is not necessarily the correct process, but that would help us in
> sort of prioritizing afterwards.
>
> DR. MILLER: We can indicate on the list where we think this ought to
> be in terms of priorities, first, second, or third.
>
> DR. WASLIEN: Yes.
>
> DR. MILLER: Dr. Durst?
>
> DR. DURST: I agree with Dr. Lund that the primary issue for this
> committee was to determine what could come out as a unified document
> from the two agencies, and I think we have a good basis for this in
> the advisory that is here. Once the comments of the committee are
> incorporated into this, and it is put on the web for further
> discussion, I think we are off to a good start for this document.
>
> I also agree with Dr. Lund that this should be aimed at the
> individuals that were in the original advisory, that we focus in on
> this particular group.
>
> DR. MILLER: That is true.
>
> Dr. Krinsky?
>
> DR. KRINSKY: In the first place, I don\'t see how you can put it on
> the web without the EPA approving of what has happened here, because
> this is a joint advisory, not a single-agency advisory, and I don\'t
> know how long that process would take and how much input they would
> want in changing whatever has been changed here.
>
> So, this, to me, is a very complicated issue with the two agencies
> putting out a simultaneous advisory, but I want to go back to a
> suggestion that the Chair raised, and that was to have more than one
> advisory.
>
> It seems to me when an issue becomes sufficiently complicated in a
> committee, somebody always says, well, let\'s divide the question so
> we can address each portion as well as we can. I think the issue of
> the children is given very short shrift in the present advisory.
>
> The statement is, \"Follow these same rules when feeding fish and
> shellfish to your young child, but the serving sizes should be
> smaller.\"
>
> Well, you know, the young child can vary from 20 pounds to 80 pounds,
> and we don\'t have any clarity in terms of what the serving size is,
> certainly not what the serving size is for children.
>
> I think if that were presented as a single free-standing advisory, one
> could, in fact, give some very useful information that would be
> immediately available rather than having the consumer having to go to
> another source to look up that particular information.
>
> DR. MILLER: Good point.
>
> The bus to take the people back to Reagan National is waiting and he
> wants to know how long.
>
> DR. DWYER: Could I ask a question, a procedural question. Isn\'t all
> of this public information?
>
> DR. MILLER: Oh, yes.
>
> DR. DWYER: So, it is already all over the Washington Post and Chicago
> Tribune, and so forth.
>
> DR. MILLER: There is nothing secret about it.
>
> DR. DWYER: What is the problem about
>
> posting it to the web and than making better things as time goes on?
>
> DR. MILLER: No problem. It\'s a question of time. It\'s a question of
> how long. Before you post things, you have got to get permission
> through the hierarchy.
>
> DR. DWYER: Well, it can\'t take more than two years, which is what it
> has taken.
>
> DR. MILLER: But, Johanna, that\'s the issue right there in a nutshell.
> It took two years.
>
> DR. ALLER: I am going to also try to bring us back perhaps\--again, I
> keep going back to the fact that we are looking at targeting at some,
> what, 8 percent of the population, and that we were provided a draft
> advisory and asked to comment on it, and at the risk of something, it
> seems to me that where I would like to see us focus on that advisory
> is we heard that, in framing that message, that several behavioral
> do\'s and don\'ts are appropriate; don\'t eat this fish, do not
> consume this.
>
> I think in my very simplistic view of this, it seems that my advice
> back to the agencies would be tinker a big with your three rules. I am
> not sure you have quite got those rules correct. Do eat this. There
> may be a group from which you can have one meal, and this gets to the
> serving size and the portion, and all of that, but here is something
> for which you need to be very, very limited, and here are the fish,
> here is a whole list in this case of the do eats.
>
> These are the ones, again getting back to that low group. I don\'t
> know if we are going to come up with that very low group or not, and I
> wouldn\'t worry about it at this particular point in time, because I
> do think it is important to get this message out.
>
> I do think we also need to say to the agencies, you made a stab at
> tuna, but we don\'t think you quite got that right, so let\'s put
> light tuna into that lower group. I am not quite sure I have heard
> enough to be convinced where albacore goes, whether it goes in the do
> not or into that
>
> once-a-week with whatever portion size.
>
> I think the other place that we thought the agency didn\'t quite get
> it right had to do with portion size, not only for the adult, but for
> children. I think that there was a suggestion, and I think it has a
> great deal of validity, to take a couple of weights of kids and say
> this is what this translates into. I think that is very useful advice
> that people can follow.
>
> Those were the, like, basic messages that I heard. The other thing I
> heard was in the delivery of these messages, there may be different
> ways to deliver that message, and let\'s get some more work on that.
> But my own sense is, if we structure our conversation next to where do
> we think that albacore should be, I would feel more comfortable going
> back, and I think we have come up with a pretty good set of, this is
> your priority, this is what we feel is the priority for the agencies,
> and we can give you these wonderful long laundry lists that we have
> heard here of lots of other things you can do spend your money and
> direct
>
> resources into more information, which I believe we do still need.
>
> DR. MILLER: That is very good. I wish I would have thought of it
> myself.
>
> Suppose we take that as a start for putting together the
> recommendations that we talked about, and we will get it out of the
> transcripts, so I won\'t make you write it down.
>
> DR. ALLER: Thank you.
>
> Because of the hour, unless there is something that is vital, really
> vital, I am going to thank you all very much for dealing with an
> extremely complex situation, thank all the other speakers and the
> staff people from EPA and FDA for making excellent presentations.
>
> I declare this meeting adjourned.
>
> \[Whereupon, at 3:55 p.m., the meeting
>
> concluded.\]