U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
FOOD ADVISORY COMMITTEE
MEETING
METHYLMERCURY
(VOLUME II)
Thursday, December 11, 2003
9:10 a.m.
Hotel Washington
515 Fifteenth Street, N.W.
Washington, D.C.
PARTICIPANTS
SANFORD A. MILLER, Ph.D., Chair
LINDA REED, Executive Secretary
MEMBERS:
ALEX D.W. ACHOLONU, Ph.D.
MARION H. ALLER, D.V.M.
H. VAS APOSHIAN, Ph.D.
DOUGLAS L. ARCHER, Ph.D.
FRANCIS FREDRICK BUSTA,
Ph.D.
PATRICK S. CALLERY, Ph.D.
ANNETTE DICKINSON, Ph.D.
GOULDA A. DOWNER, Ph.D.
RICHARD A. DURST, Ph.D.
JOHANNA DWYER, Ph.D.
JEAN M. HALLORAN
DOUGLAS C. HEIMBURGER
M.D., M.S.
NORMAL KRINSKY, M.D.
DARYL B. LUND, Ph.D.
MARK F. NELSON, Ph.D.
ROBERT M. RUSSELL, M.D.
CLIFFORD SCHERER, Ph.D.
CAROL I. WASLIEN, Ph.D.,
R.D.
C O N T E N T S
PAGE
Call to Order
Robert M. Russell, M.D. 5
Focus Group Testing
Dr. Marjorie Davidson 5
Questions of Clarification 10
Joint Advisory
CFSAN: Dr. David Acheson 18
EPA: Jim Pendergast 23
Questions of Clarification 36
Public Comments
Susan West Marmagas 83
Physicians for Social Responsibility
David Wallinga, M.D., MPA
Institute for Agriculture and Trade
Policy 90
Caroline Smith DeWaal 96
Center for Science and the Public
Interest
Carol Stroebel 97
Children's Environmental Health
Network
Robert Califf 104
National Fisheries Institute
Edward Groth III, Ph.D. 110
Consumers Union of U.S., Inc.
Michael T. Bender 118
Mercury Policy Project
C O N T E N T S (CONTINUED)
PAGE
Public Comments (Continued)
Susan Boehm, Ph.D. 125
New York Academy of Science
Jane Houlihan 132
Environmental Working Group
Rona Applebaum 157
National Food Processors Association
Diana Zuckerman, M.D. 167
National Center for Policy Research
for Women and Families
Dr. Joshua Cohen, 175
Harvard Center for Risk Analysis
John Stiker 188
Bumble Bee Tuna
Lillian Beard, M.D. 203
George Washington University;
Howard University
FAC Discussion and Comments 209
P R O C E E D I N G S
Call to Order
DR.
RUSSELL: Since we are starting late, we
thought we should go ahead. We have a
talk today on focus group testing by Marjorie Davidson. Marjorie, please go ahead.
Focus Group Testing
DR.
DAVIDSON: Thank you. Good morning. Carrying forth our discussion on the process that we went through
in developing our Methylmercury Advisory, once we had our initial draft, we
took it to focus group testing.
In
the draft version that we took to our focus groups, I want to remind you that
the message
was for pregnant women or women who may
become pregnant, nursing mothers, and young children was included in the whole
advisory this time, as well.
We
have eight focus groups. They were
geographically located throughout the country and we picked high fish-eating
areas - Calverton, Maryland, New Orleans, Louisiana, Seattle, Washington, and
Minneapolis, Minnesota.
We
held mixed gender groups, as well as low education and high education
groups. There were groups of pregnant
women, women of childbearing age, and parents of young children. We held them in November 2001 and as Denise
mentioned yesterday, it was an iterative process. We took the initial draft we had and modified it as we went along
through the focus groups.
I
would like to add that virtually everyone but probably one or two people was
already eating within the limits of the consumer advisory, eating fish within
those limits.
The
goal of the focus groups was to examine risk communication formats, to look at
various approaches we could use at explaining the risk of methylmercury in fish
and also we wanted to see how these consumers would respond to the advice.
We
were particularly paying attention to the three areas that were recommended by
the Food Advisory Committee, the enhanced attention to young children that was
not included in the advisory, the
merging of commercial and noncommercial
fish, as well as a discussion of tuna.
We
were continuing, as we have constantly done as we have been working on this
advisory, we wanted to be sure that we kept a balance between letting consumers
know about the risks of methylmercury in fish, and not jeopardizing their
eating fish to get the nutritional benefits from it.
Our
findings were that most people want a very simple message. This is not unusual for fish advisories, it
is pretty much the case for all of our health education messages. People wanted to know what the arm was and
they wanted to know how to avoid the harm.
As
always, there were people who were greater information seekers, who wanted to
know more information than the norm, and some of the things they wanted to know
about were what exactly would methylmercury do to affect the health of the
child, data about particular species of fish. They wanted to be able to look up
this particular fish
they eat, and they also wanted to know
how methylmercury would affect others, other members of their families, other
members of their community.
Also,
our results regarding tuna, we found that the difference between tuna fillets
and tuna steaks, the different methylmercury contents versus white canned tuna
was not known to most people. To most
people, that was new information. As a
results, some participants said that they would avoid tuna steaks and albacore
tuna and move more to the lighter tuna.
The
results of tuna in general, how they felt about their actions to tuna as a
fish, I will talk about more in the general reaction to fish advisories.
What
about recreational fish? Again, this is
the first time we had merged the recreational fish advice with the commercial
fish advice. We learned that avoiding
commercial fish when you were eating recreational fish in the event that there
was no fish advisory in a particular state was new information to many
participants.
We
also learned that people, for the most part, think of their fish-eating
practices as holistic. They don't think
I ate three commercial fish this week and two sport-caught fish.
I
personally found it interesting that quite a number of people in these focus
groups weren't aware that they needed to look at state advisories on the safety
of their fish. That was surprising to
me.
What
did participants say they would do?
Almost all participants reported that they do not eat fish. This was not particularly difficult to do
since most of them did not eat that species of fish anyway, but some
participants said that they would eat less fish and some participants said they
would serve less fish to their children, and this was the same as the
description of what they would do with tuna.
Another
finding that we found, there was a spillover effect as actually was the case in
our first set of focus groups, as well, that once they learned there was a risk
of methylmercury in fish,
they thought it was important to tell
others about it, because if it wasn't good for a pregnant woman or a young
child, it probably wasn't good for them either.
So,
in conclusion, I would like to say that it is our belief that women will
follow, they won't exceed the safe fish advisory, however, we will be
challenged to ensure that they continue to eat fish and gain the nutrients from
it.
DR.
RUSSELL: Before you start the
questions, I just want to remind you to turn off any cell phones that you have
or turn them to vibrate at any rate.
Questions,
please.
Questions of Clarification
DR.
DURST: I was just curious, how were the
participants in these focus groups selected?
I mean as far as the breadth of their education, and so on.
DR.
DAVIDSON: We had separate groups, which
were high school graduates or less than high school, and then we had groups
that had some
college or had finished college, and
then we had some that were a mixture of the two.
DR.
APOSHIAN: I am very ignorant of focus
groups and I wondered, is there any evidence that validates the use of focus
groups for this sort of thing?
DR.
DAVIDSON: Well, they are used
traditionally to find more patterns of response from different kinds and groups
of people. It is a research tool that
is used frequently in social science research.
DR.
APOSHIAN: If I were doing a study and
published something, one of the first things that a referee would ask is how do
you validate the analytical techniques you are using, and I am curious and
wonder whether there is some reference that is available to us to validate the
use of focus groups to obtain this kind of information.
DR.
LUND: I am not a sensory scientist, but
the use of focus groups in a wide variety of industries, particularly the food
industry, is well documented and I think there would be books and
other materials that would have been
peer reviewed, in fact, attesting to the validity of using focus groups.
DR.
RUSSELL: Dr. Scherer.
DR.
SCHERER: The use of focus groups, keep
in mind, really, the objective is to get them to help you with the message in
this case. I don't think there was any
attempt to really try to use it to get a more demographic profile about how
people react to the message. It was for
improving the message over time, getting people to interact.
But
I guess my question would relate to the extent to which different demographic
groups, particularly, for example, Asian groups, might react to the message in
a very different way.
It
would seem to me that one of the issues might be that certain groups--again, I
refer to the Asian group--may eat a narrower range of fish, they may have
different names for the fish, there may be other kinds of issues that are
relevant to particular demographic profiles.
I
was wondering whether there was any
thought given to examining other
groups, for example, a focus group specifically with
Asian-Americans or some other.
DR.
DAVIDSON: We haven't formally through
FDA, but we are informally working with folks in California right now, with the
State of California, as well as our local public affairs specialists in the
field there, and trying to see how this advisory could be translated into that
community. I totally agree with you.
DR.
DURST: It was just to follow up again,
but I think your comments clarified, because I was a little concerned that with
the focus groups, that if they were not representative of the general
population, you were going to get a biased result.
That
was my original question about how these people were selected. If they were volunteers, again, you are
going to get people who are more proactive in things and would not be
representative.
DR.
ACHOLONU: As a follow-up to that, I
was wondering about the focus
group. Did you include the
African-Americans because it is believed that this group eat more fish than
other groups?
DR.
DAVIDSON: African-Americans were part
of these focus groups. There wasn't a
special African-American focus group.
DR.
SCHERER: I had one other question and
this relates more to perhaps a little bit broader issue than just the focus
groups, but it seems to me that going through a process in which we evaluate
the message and have some understanding of how people are reacting to that
message is really only the first step, because it seems to me that the real
issue is the behavioral step.
That
is a much more difficult one to try to analyze and understand, yet, in a
message as complex as this particular message, it seems to me that that is
really what we are trying to do.
We
really would not want people to, number one, stop eating fish as a result of
seeing or remembering one little bit of the message, and at
the same time, we don't want them to
say yes, I understand the message, but I am going to ignore it.
So,
it seems to me that that is the real component of trying to understand. I realize that that is a very difficult
thing to begin doing, but I am just wondering whether there is any thought
about giving some effort to try to understand at least behavioral intent, if
not actual long-term behavioral measures.
DR.
DAVIDSON: How it is planned further
than what I reported on at this moment, but we are also not finished with our
efforts in this regard, as well. I
appreciate very much what you are saying.
MS.
HALLORAN: I think that is a very
interesting point. You obviously
reported some statements of intent about behavior. I don't know if you have a way to follow up with the members in
six months and a year to see if they report actually changing buying habits.
DR.
DAVIDSON: I would not surmise that we
would be following up with these
particular members, but we do have evaluation techniques that we will undertake
at FDA, more of a survey nature actually, to find out what people are actually
doing regarding the fish advisory.
DR.
DOWNER: I have conducted several focus
groups for different things myself in terms of health. I am just curious, can you tell me exactly
how the focus groups were done in terms of exactly what you did as you got the
groups together?
I
have found that when you select a group and you have somebody who is very
vocal, that they can easily sway the discussion and the intent is changed. So, what I usually do is I have something in
writing for people to fill out the form and then go into the discussion.
Can
you tell me if you did something like that or it was completely
discussion? The information you
gathered is very important and was very worthwhile actually, but I am just
curious to see if there are one or two persons in several
groups that had the majority input and
you didn't get some more substantive supplemental information from other
members of your focus group.
DR.
DAVIDSON: I certainly agree and
appreciate the comment that you are stating.
I actually did not do the focus groups, we hired a professional company
to do them, who are skilled in turning the discussion away from folks that tend
to dominate.
That
was also one of the reasons why we divided education up for the most part, so
that the higher educated people didn't dominate the group.
DR.
DWYER: Dr. Russell, could you just tell
us or could someone tell us - we have got a bunch of press releases here, one
of which seems to be from this year, one of which seems to be from last year,
and one of which seems to be from the year before.
I
understand why the press release from this year is here, but why are the others
here, just as background, or what?
MS.
REED: Can you just tell us what you
are referring to, Dr. Dwyer? These were all distributed this morning, I
am presuming by public commenters, that we will be hearing from this
morning. It's just background
information.
DR.
DWYER: Oh, I see. Fair enough.
DR.
MILLER: I want to, first of all,
apologize for being late. It just took
two hours to come in from Bethesda, normally, a 25-minute drive. I am not sure whether it was this meeting or
it was the weather.
In
any case, we now have come to the essence of the discussion, the presentation
of the joint advisory.
David,
you are going to start out?
Joint Advisory
CFSAN
DR.
ACHESON: Yes, Dr. Miller. This again is going to be a joint effort
between myself and Jim Pendergast from EPA, and I am just going to give a
little introduction and overview of some of the major changes in the new
advisory and then hand over to Jim to continue.
These
first few slides just summarize some of the major points in response to the
recommendations and how we have tried to incorporate those into the revised
advisory.
The
first point is that this new advisory does cover both commercial and recreational
fish and shellfish as part of the joint effort between FDA and EPA.
Secondly,
this revised advisory is directed towards pregnant women, women who may become
pregnant, nursing mothers, and young children, and that, as I explained
yesterday, is a slight departure from what FDA did in 2001 in that there is
more emphasis on young children than we had in the past.
The
third major issue in response to the recommendations, the Do Not Eat list, that
is unchanged, there was no recommendation to change that, and again as I
pointed out yesterday, we do not have new data, new science that would suggest
that we should change that, but clearly, we will keep an open mind, and as we
pursue testing on, for
example, tilefish, we will revise the
advisory accordingly.
The
fourth point in relation to the amount, again, the amount, the 12 ounces has
not changed. That was the same as
2001. What we have done is we have
tried to clarify that message in response to the request or the recommendation
from the committee to be more specific about variety.
As
we explained yesterday, we have found a way to do that through new language,
and as you have just heard, that has been tested in the fact that we are now
saying two to three servings. So, that
is how we responded to that.
The
fifth point in relation to locally caught fish. The advice on the amount of the locally caught fish again has not
changed. It is the same as in the 2001
EPA advice. But what we have tried to
do is to clarify this issue of don't consume locally caught fish and
commercially caught fish in the same week, so that there is a better
understanding of that issue.
Finally,
again, this was really in
response to focus group testing and
what worked the best was that we have developed a series of questions and
answers on specific points, and that is a departure from the 2001 format, in
fact, it is quite a significant departure.
As
you will see on the draft, we now have a series of questions and answers that
cover a variety of issues. We certainly
don't intend that this is going to be a compendium of methylmercury in fish.
We
anticipate that people may have other questions, so we provide a hot line
number, and we provide a web site which we would augment with data and
information and keep updated again with specific amounts of methylmercury in
the different fish species as we develop it.
The
one point again I want to emphasize in relation to the Q and A is what we said
about tuna, which I did mention yesterday, and the bottom part of this slide
just is the quotation of our answer to that question.
I
am not going to re-read that, but I just
want to point out that we are now
saying something specific about tuna.
We decided that a factual statement about tuna was the most appropriate
way to go and added the statement at the end that you can safely include tuna
as part of your weekly fish consumption diet.
Now,
that statement, linked with the second rule in the advisory, would indicate
that if you mix up the fish, as we are
recommending, and you want to consume tuna, then, you would essentially be
consuming four to six ounces of tuna a week, because you would only eat one
type of fish per week. If you have
eaten one type of fish, then, you need to do some other kind of fish, some
other type of fish if you are going to have a second fish meal.
That
really summarizes the main issues and I really just wanted to pick those out
and focus on them just briefly before handing over to Jim Pendergast, who is
going to take you through kind of the full advisory from beginning to end, so
maybe you can defer questions on this part until we
are completed.
Joint Advisory
EPA
MR.
PENDERGAST: Good morning. I guess this is the part that folks have
been waiting for is what is the draft advisory. As Marjorie had said, during the focus groups, we had tried
different types of the advisory, we learned as we went along. If the message wasn't getting across, we
tinkered with it and tried to make it more clear and tested it at the next
focus group.
So,
what you are going to see on here is what has resulted from the process of
going through the four focus groups.
The
draft advisory has three parts. There
is a risk message, what is the risk, there is the consumer advice, and as David
said, there are some Q's and A's that we put at the end to help provide some
more information. A lot of the reasons
for these Q's and A's came about from some of the questions that we heard at
the focus groups.
The
first part of the risk message is who is at risk. It is in the title of the document
itself, women who are pregnant, who may
become pregnant, nursing mothers, and
young children.
We
also explained why they are at risk and we talk about the benefits, the
positive benefits of eating fish. We
want to make sure that that point comes across, and that is something you also
heard from the focus groups, why should we eat fish, and also point out that
what are the potential problems of eating fish that are high in
methylmercury. That is part of the risk
message.
Precisely
what we say is that, "Fish and shellfish can be an important part of a
balanced diet. It is a good source of
high quality protein and other nutrients and is low in fat. The FDA and EPA are advising pregnant women
and nursing mothers to eat the types and amounts of fish and shellfish that are
safe to prevent harm to the development of their baby or young child."
We
also provide a statement that, "If you follow the advice given by FDA and
EPA, you will gain the positive benefits of eating fish but avoid any
developmental problems from mercury in fish."
Again, this something that we heard
from the focus group is that why should we eat fish and what is wrong about
eating fish that are high in mercury.
The
second part of the advisory is actually the advice to the consumers. We have tried to break it down into three
parts. We tried to get it to a message
that was clear, so the results in the focus groups, that the feedback we got
from them is that they understood what the message was and they would be able
to tell us how this might affect their behavior.
The
first part is similar to what we had in the 2001 advisory. There are four types of fish based upon the
information we have that we recommend that the target of the advisory, pregnant
women, women who may become pregnant, nursing mothers, young children, don't
eat the four fish we have here: shark,
swordfish, tilefish, and king mackerel.
The
second rule is the part that David talked about just briefly before, is that we
recognize that levels of mercury in fish can vary,
and we recommend that you can safely
eat up to 12 ounces, which is two or three meals a week, of other purchased
fish and shellfish a week, but mix up the types of fish, and do not eat the
same type of fish and shellfish more than once a week.
What
we mean by this is that, for example, if a pregnant woman was going to have a
meal of tuna, which is 4 to 6 ounces, that that would be the sole meal of tuna
that week, and that she would balance that with eating a different type of fish
that week.
The
same thing is that if a woman was eating, let's say, grouper, that would be one
meal of grouper a week and balance it with different types of fish.
As
we have talked before, is that in the implementation that we will be having up
on the FDA website and links from the EPA website to what we know about levels
of mercury in fish, so that the consumer who wants to do research for himself
or herself can go and look and find what types of fish that perhaps are lower
in mercury and choose how he
or she is going to construct their
diet. That is a piece of information to
be able to help.
The
third rule is the rule that brings in the role of local advisories. What we are saying is for people to check
their local advisories about the safety of fish caught by family and friends in
your local rivers and streams. If no
advice is available, you can safely eat up to 6 ounces, one meal per week of
fish that you catch from local waters, but don't consume any other fish during
that week.
We
needed to do this because across the United States where people are catching
fish, the amount of mercury in fish varies, and vary for something as low as
0.05 parts per million as an average for species up to almost 0.9. This varies based upon the type of species,
the location, the age of the fish.
States
have already issued advisories based upon what they know from data that they
have collected. We want to make sure
that consumers know about this information. This is the reason for
this third rule, and it is part of the
implementation links that go from here to a website that we have in EPA that
links to advisories that states have issued around the country.
We
also recognize that states can't be everywhere and test fish everywhere. What to do about those waters where a state
has either not issued advisory or doesn't have any information to be able to
say that folks can safely eat fish at 8 meals a month, 12 meals a month, or
something like that, that is the reason for the 6 ounces, it catches where we
don't have information, and it is based upon what we know from where we do have
information and taking a look at essentially a median of the various species,
so that folks can have some level of protection or some level of knowledge in
terms of what they can safely eat.
Recognizing
that concentrations can be high in some of these fish, that is why we came up
with the recommendation that if you eat that one meal a week of recreationally
caught fish, that's it, don't add anything else to it.
In
recognition of small children, we also recommend that the people following the
advice follow the same advice with children, but recognize that children have
smaller body mass and they tend to eat a little bit less, that they should eat
less fish or less than the 12 ounces.
Now,
the Q's and A's. Again, this comes from
the balance of how much information you put upfront in an advisory that gets
the message across without overwhelming people so that they lose the message.
It
also comes from the part of being able to recognize or to respond to some of
the questions that we got or that we heard from the focus groups, the questions
that they asked the moderator, places where they said they needed more
information.
One
of the most frequently asked questions that we heard was, "I thought fish
was good for me. Why are you telling me
that I should constrain the amount of fish that we eat?"
We
tried to answer that. It is, that is,
fish and other seafood have long been considered to
be good sources of protein with the
added advantage of being low in saturated fat and high in healthy omega-3 fatty
acids. However, scientists have learned that shark, swordfish, king mackerel,
and tilefish contain levels of mercury in them that may harm your unborn child.
This
is why FDA and EPA are advising you to avoid these fish. By eating other types of fish in moderation,
you will get the health benefits of fish, trying to directly respond to the
concerns and the questions that we heard at the focus groups.
The
second question is about tuna. David
went over this question before, but this was also a question that came up as
folks would ask that question, what about tuna, and they did not understand, as
Marjorie said, the differences between the mercury levels in albacore tuna and
tuna steaks as compared to the chunk light tuna. We wanted to be able to provide that information to them.
The
third question is, is methylmercury in
all fish, and this is recognition of
the idea that there is a natural reaction of fearing that there is something
bad in your food, that people may run away from that food completely.
We
know that there is methylmercury in all fish, and we needed to be able to
provide the appropriate information for people to understand that it is the
level of mercury that is important in the amount of fish they eat, not the fact
that there is some measured mercury in a fish.
So,
we answer that by saying nearly all fish contain traces of methylmercury. However, larger fish that have lived longer
have the highest levels of methylmercury,
so they have had more time to accumulate it.
One
of the questions that Marjorie pointed out is people wanted to know why is
there mercury in the larger fish.
Other
types of fish are safe to eat, if you want more information, where to go for
the information, trying to respond again to the focus groups.
Another
question that came up in a couple of focus groups is, "But I am not
pregnant, so why should I care about this?" Some of this also came to a point that was made in a couple of
the groups, that not every woman intends to get pregnant, and therefore, women
need to understand the message if they could become pregnant.
This
is a very important point that we needed to clarify, because at one group we
actually heard a woman, who to me appeared to be in her 30s, said, "I am
not going to have any more children, so can I just eat all the fish I
want?"
This
is to try to answer that question, that mercury can accumulate in your
bloodstream over time, it is removed from your body naturally, but it may take
over a year for the levels to drop significantly, therefore, it may be present
in a woman even before she becomes pregnant. That is why it is important, of
women who are of the age that they could become pregnant, and we also suggest
that if they have questions about a concern that they may have consumed large
amounts of mercury, to
talk to their physician.
Another
question that came up is about the local information, why be concerned about
the local information about advisories.
We tried to address that, as well, to explain that some kinds of fish and
shellfish may have higher or much lower than average levels of mercury. Like I said, from the information we have
based upon species, it can range from 0.05 parts per million to almost 0.9
parts per million. That is an order of
magnitude variation.
This
is the reason why people, this is how we try to answer why folks needed to
understand about locally caught fish.
Another
question that we heard is how do I get this information, how do I learn about
local advisories, and we try to answer that question by pointing out that
states have fishing regulations booklets, some of them do. You can contact local health departments,
and we also provide links to state and tribal contact information.
One
of the last questions on here is what
is mercury. Recognizing that mercury is an element and it has been around,
that it occurs naturally in the environment and also can be released into the
environment, from our view, primarily from air emissions through industrial
pollution.
It
falls from the air, accumulates in streams and oceans, turned into
methylmercury in water. We try to
provide that information. We did hear
folks who asked questions, well, how does mercury get into the fish anyhow, and
this provides some of the basic information, so that folks can understand.
At
the very end of the advisory, of course, we provide links to where to go for
more information, both with FDA and EPA with websites, and in the case of FDA,
with their hot line.
We
also provide links to the state and tribal public health offices that issue
fish advisories, so people can very quickly find where the local advice is.
Lastly,
where are we going from here? The
advisory we have right now is draft. We
are
seeking input today. We have some other steps along the way. As Marjorie said, we did talk to focus
groups.
Back
in July, we had a stakeholder meeting where we talked about some ideas, but in
the future, we have a National Forum on Contaminants in Fish that EPA
co-sponsors with ATSDR. We will be
discussing with state and tribal public health officials the draft advisory,
get some of their concerns and ideas on that and what we need to do.
We
are targeting to be able to come up with a final advisory by February, after
receiving the input that we can possibly gain on here, again with the overall
idea of having a message that is able to capture the sense that it is important
to eat fish, but it is important not to eat too much of the wrong fish, and to
try to get that simple message, so that people understand that and change their
behavior to follow that in ways that protects their house.
Following
that, in 2004, we, in FDA, will actively engage in getting this message
out. We
have not yet sat down and worked out
all the various ways in which we are going to do it, we have just been working
on the draft advisory, but we recognize that getting an advisory done is just
the first step. The next 10 steps is in
the effective implementation.
With
that, I think that closes this presentation.
DR.
MILLER: Thank you.
Questions of Clarification
DR.
ACHOLONU: I noticed that in your
presentation, Item 7 has what is mercury.
I have a copy of the draft advisory here. It does not indicate what mercury is, but goes on to say,
"Mercury occurs naturally in the environment." Don't you think that you should include what
mercury is?
MR.
PENDERGAST: That is a good point on
here, and I actually said it myself, showing a little bit of what I know, that
mercury is an element. It might help to
start off with saying that.
DR.
MILLER: Dr. Scherer.
DR.
SCHERER: I would like to first
congratulate you on all the work you
have done in terms of structuring the message, because I think often we end up
with messages that people just write and think that's the way it should be
done, so that you have had a lot of input into the message.
You
seem to have arrived at a message that is understandable by focus groups, but I
wonder if there is a point at which, in a sense, we have simplified a bit
beyond meaning. Let me try to explain
what I am talking about.
I
guess I am one that advocates that we need to simplify messages for people to
understand, but if we lose what the science and the meaning is about, then, I
have concerns.
The
message essentially says do not eat the same type of fish each week, and I
understand why the message is that we should eat a mixed grouping of fish, but
as a consumer I look at it and say wait, I eat trout, and I look at the list,
and if I eat anything other than trout,
I am increasing my intake of methylmercury.
So,
somewhere I may be losing some of what the message is trying to do. Does that make sense to what I am asking?
MR.
PENDERGAST: It does, and I think we
thought about this at the same time, how do you get that type of information in
people's hands for making decisions.
That led us to developing the database or the list of what we know about
levels of mercury in fish and to make that available, so that in the case that
if you ate trout, and you would be looking for something that was lower in
mercury.
DR.
ACHESON: My perspective on that is this
is a balance between once you have eaten your portion of trout, you think,
well, I know fish is good for me, what should I do next, and the idea would be
that you would have something else that week.
If
you really want to go and investigate, you could look up on the web and say,
okay, I
really want to keep it low, which is
why we have also gone for the 12 ounces, because we figured that if you have
had your portion of trout, say, 6 ounces, and you want to eat another serving
of fish, another 6 ounces of something, so long as you have got the mix-it-up
message, you are going to go for something different, and it will still keep
you safe even if you don't want to go and investigate.
Then,
you can certainly eat trout again the following week. This is sort of going week by week. But I agree with you, it is difficult to keep it understandably
simple and yet not lose the science. We
have tried to get that balance and certainly if you have some perspectives that
could help ensure we maintain that, we would love to hear them.
DR.
MILLER: Dr. Krinsky.
DR.
KRINSKY: It seems to me there is a huge
difference between reading the advisory and listening to the presentation that
Dr. Pendergast gave, and listening to it makes it so much clearer if I try to
put myself in the position of a
consumer, of a pregnant woman or
something of that nature.
So,
I just wonder, in the focus groups, were they simply given the draft advisory
without any comment from the individual who was administering the focus
group. I don't know how focus groups
function, so I just wonder if I could get some clarification on that.
MR.
PENDERGAST: Yes. The way that the focus group worked, and the
participants were in a room with a moderator.
The moderator read the advisory, that current version of the advisory,
and then people reacted to that. There was no explanation that was given by the
moderator.
We
did break it up into two parts. The
first part was the risk message with the consumer advice as one part, and then
the participants discussed that. Then,
we went for the Q's and A's.
What
we learned from that part was that a number of the questions that people had
popped up when they read the advice, like isn't it good for me, isn't fish good
for me, and things like that,
and the Q's and A's then answered those
questions on there, but there wasn't any explanation by the FDA, EPA, or the
moderator as the focus group went on.
DR.
KRINSKY: So, the focus group was given
the full document that we were presented with.
MR.
PENDERGAST: They were given the version
at that time, the draft advisory evolved.
The group in Calverton, which is the first one, had the first iteration
of it, and then we learned from that.
We made a second version, and then the group in New Orleans had the
second version. We learned from that
and made some revisions to it, then, Seattle, and then revisions, and then
Minneapolis.
So,
what you see is the culmination of four iterations and learning from the four
groups.
DR.
KRINSKY: So, how many focus groups
received the document that we are reading now?
MR.
PENDERGAST: The precise document?
DR.
KRINSKY: The precise document that we
received.
MR.
PENDERGAST: None of them, because this
represents the last change from the Minneapolis one, however, the change from
Minneapolis to what you see in front of you was very small. The largest change was after the first
group, and the groups in New Orleans was the second group, saw pretty much the
same language, the three parts of the message, the Do Not Eat, the 12 ounces
and mix it up, how to integrate the local advisories, they saw that.
Where
we spent most of time in the revisions was in the ordering of the questions and
precisely which questions.
DR.
KRINSKY: Thank you.
DR.
DOWNER: Thanks for a very informative
presentation. I decided to take in a
few of my teaching tools for my consumers and patients to let the committee see
what a serving of tuna looks like, and this is not a lot.
So,
when we are hearing 12 ounces, 12 ounces compared, for example, to 3 ounces of
hamburger patty, it looks a little bit more
substantial than this 3 ounces or this
quarter cup rather, of tuna. It is not
a lot of tuna.
My
challenge is in talking to patients about increasing their fish consumption,
when you hear limit, along with it you hear avoid, and that is a big challenge.
That is the big challenge, how do we get the message out to say yes, we say to
limit, not avoid.
So,
the slide that says how much fish to eat, the consumer advice, how much fish to
eat, do not eat shark, swordfish, I would like that slide to include what to
eat. The method is too far removed.
The
very slide that says do not eat so-and-so, I urge you to put instead eat
so-and-so, et cetera, and you can give a reference to where they can go on to
get other information, because it is easy to just look at this and say oh, I
give up, I give up.
One
week you say or one year you say eat more fish and cut out the red meat, the
next time I am hearing eat less of this, I am confused, so I
give up. So, I urge you on this very slide that says do not eat shark, put
the positive message with it. That is
the only thing, as consumers and as clinicians--I am a nutritionist in clinical
practice--will give to my patients and say here, this is the other side of
this.
MR.
PENDERGAST: Thank you.
DR.
MILLER: Do you have another comment?
MR.
PENDERGAST: No, I think that is a good
piece of advice for us to consider.
DR.
MILLER: Jean.
MS.
HALLORAN: If I understood the
presentations correctly yesterday, from the exposure analysis, I think it was
quite clear that you actually, for 98 percent of the population, can achieve
the desired exposure only if you eat 12 ounces of low mercury fish, and it
won't work if you are mixing it up with middle mercury fish.
So,
is it correct that if you, for example, had grouper, orange roughy, and
albacore tuna for your mixed-up variety that week, isn't it correct that you
would be over the reference dose?
DR.
ACHESON: The short answer to your
question is if you were to eat grouper--what was the--
MS.
HALLORAN: Orange roughy and albacore.
DR.
ACHESON: Yes, and if you were to eat 4
ounces of those, based on the means, you would be over the RfD, yes. We regard the RfD as an important guideline
as to where to target.
As
the discussion has gone on, what we are trying to do here is to achieve a
balance between the health benefits of fish and the dangers of methylmercury.
The
exposure assessment is a model and it was a very useful guide to keep us on
track. What we took from the exposure
assessment was that if we can get the word out, we will be improving over
current baselines.
We
may not get everybody below the RfD, but we will do better.
MS.
HALLORAN: But you are quite definitive
in the advice. You say you can safely
eat, safely eat, and yet it seems to me your
analysis shows actually that you can
only really safely eat the bottom 20 fish, so I would actually like to second
the suggestion of Goulda that perhaps you could say safely eat 12 ounces of low
mercury fish and then list half a dozen of them, and encourage eating those,
because it is quite a long list.
DR.
MILLER: Dr. Dickinson.
DR.
DICKINSON: A lot of people are eating
more fish now because of concerns about omega-3 fatty acids, getting more omega
3 fatty acids, and, in particular, they are turning to salmon, because they all
know that salmon is one of the high sources of omega-3's, and fortunately,
salmon is also one of the low category for methylmercury.
So,
it seems to me that it would be very beneficial for people to know that even
several servings a week of salmon would not put them above that level, and if
that means giving them more advice on the entire selection of low mercury fish,
I think that would be very positive, but, in particular, I think they should
know that salmon is
one of those low mercury fish, and that
if they are seeking to increase their omega-3 levels through eating salmon,
they can safely do that.
In
fact, I think it is not quite true what it says about not eating the same fish
more than once a week, because if you are eating from the low end of the list,
and, in particular, if you are eating salmon, you may be quite well off eating
more than one serving of those kinds of fish a week.
DR.
ACHESON: Those are excellent
points. The first draft that we tested,
we put in a list of low fish, included salmon, light tuna. It didn't work, people didn't understand it.
What
we are hearing here is somewhat of the same thought process that we went
through - why don't you list them, why don't you do this, and where we have
tried to end up with is a balance between what is understandable and what
people can do considering this is a national advisory.
We
have certainly gone down that road of, well, let's list everything.
DR.
DICKINSON: But there is a difference
between listing everything and mentioning the two or three things that people
eat the most of, and salmon is one of those.
DR.
ACHESON: I agree with you, and that is
exactly what we did in the first draft.
If you look at the first draft--I forget which tab it is in the
notebook--but where we have those three drafts in there, that is in there, in
our variety explanation, and the focus groups didn't understand it.
DR.
DICKINSON: Well, that may have to do
with the way it was said, as well as with the message itself, but I think that
is worth another look.
DR.
ACHESON: Thank you.
DR.
MILLER: Dr. Durst.
DR.
DURST: I just have a few comments,
several of them. I agree completely
with my colleagues that my first reaction when it talked about mixing the
varieties of fish was that it added confusion to me and, just to reiterate,
that
if you pick low mercury-containing
fish, you can eat as much of that as you want without having to mix the
species. So, I think that phrase in there is more confusing than helpful.
On
the point of mercury and what it is, the way it is stated in here, mercury
occurs naturally in the environment, it is really mercury compounds, it is not
the element, it doesn't exist in nature, so I am not sure if we want to get into
all the science of it, that it's an element, which would be more or less
meaningless to most of the population.
I
also agree that the three rules, the positive points should be emphasized, No.
2 maybe moved to No. 1, and I would recommend dropping out the mixing of the
types.
Finally,
I think in presenting this in the final document, it would be nice to highlight
just important aspects of it. There is
a lot of verbiage in here that the consumer might be interested in, but they
are going to see a two-page document that is going to be intimidating to most
people who won't want to read through
the whole thing, but if you highlight and bold in some way some of the main
points, this might actually get the message across.
Then,
if the people want more information, they can read the fine print, if you will.
I
would also like to see some kind of a listing of the fish with the ranking as
far as the amount of methylmercury in them.
One of the documents we were given this morning from the Consumer's
Union has a nice table of that sort, and I would recommend providing at least
that kind of information.
MR.
PENDERGAST: Those are very good
thoughts in there. Those are some of
the things that we are also wrestling with is that, how much information can
you put out before people stop reading.
That
is what led to the format that you have in front of you, where I think in one
of the first iterations, some of those questions and answers for part of the
verbiage of the advisory,
and people in the first focus group could
not get past that.
They
had gotten to that first paragraph, which is about what was mercury and where
is it in the environment, and then they started getting worried, because they
never got to the actual advice.
Some
thoughts, you know, I appreciate thoughts in terms of how to help focus people
to where the thoughts are in there. We
also had some thoughts about, you know, putting the information about fish and
methylmercury content in the fish.
That
table, in itself, could depending on the number of species in there. Again, since it is national advice, we want
to be able not just to give examples, but to be able to give all the
information you have, because people eat different types of fish.
We
agonized over how to do that and came up with having a web site where not only
would we be able to put a longer list on there, we would be able to update
it. Instead of having to have
printed advisories out and have to
continually change what is in print, we would be able to continually change
what is there on the website, so people would have the most current
information.
DR.
DURST: Well, the only problem with the
website, it is only going to hit a certain portion of the population, not the
poorest segments and that sort of thing,
so I think the website is nice for the Internet-active type people, but
it is going to miss an important segment of the population.
DR.
MILLER: Dr. Russell.
DR.
RUSSELL: I actually liked the advisory
very much, I think it is quite clear. I
think it can be tweaked some, but I think it is a really good job.
I
wondered, however, there is just one little thing that came up in my mind, why,
at one point, 12 ounces is defined as two to three meals, whereas, 6 ounces is
defined clearly as one meal per week. I
just wondered why the two to three if you are trying to make the message very
clear.
MR.
PENDERGAST: That is a good point. Do you know that meals depending upon--are
people's choice. I know that my wife's
meal and my meal are different sizes on there.
DR.
RUSSELL: I realize that, but in trying
to make it clear, I just wonder whether people would start thinking is it three
I could eat, or two, or one, or I can't remember.
MR.
PENDERGAST: That is a good point. We will really consider that one.
DR.
MILLER: Dr. Aposhian.
DR.
APOSHIAN: I just have three comments I
would like to make. I agree with Dr.
Krinsky as to the presentation seemed to be different than the advisory. I have lost count because I was interested
in what someone else said. You
mentioned tuna fish many more times in your presentation than it is mentioned
and cautioned about in the advisory.
That is number one.
Number
two, as Dr. Durst was saying, the poor group, the uneducated group, if you
will, the immigrant group, if you will, may not read
something this long. I think we have two extremes.
You
have the Ph.D./M.D. who is so busy that he is just going to read the first
line, and then you have the poor people who either have to work for a living
and don't have the time, but you ought to read the paper that the good people
from the EPA have put out on environmental health perspectives, and it points
out that as far as racial or ethnic groups are concerned, Asians, Native
Americans, and Pacific Island women have anywhere from at least about one point
times higher amounts of methylmercury than do the so-called white Caucasian
American.
So,
I think what Dr. Durst was saying is to reach that group that is not as highly
educated, that may not have the time or the desire to read something this long,
my suggestion would be, as Dr. Durst made with highlighting, is maybe even
using bullet statements that will get across.
I
have one more comment, that I hope an FDA attorney looks at the consumer advice
that says benefits and risks. If you
follow advice given by
FDA and EPA, you will gain the positive
benefits of eating fish, but avoid any developmental problems from mercury in
fish.
I
don't testify in court anymore, it is just too much trouble, but that would
just increase the consulting fees of most toxicologists that I know that do go
before court, and I think that is a very dangerous statement for a governmental
organization to make.
MR.
PENDERGAST: I appreciate the advice on
there. That is something that I know that attorneys would take a look at.
Getting
to your comment about the length of the advice and message, that is something
we also think about on here. As we get
into the implementation in terms of how does this message get out, certainly we
know that people will be taking it, paraphrasing it, putting it into
publications.
Within
EPA, we have worked joint with ATSDR in terms of getting pamphlets out in the
hands of pediatricians and OB-GYNs to be able to
help pass the message on. We even have pamphlets in Vietnamese, Hmong,
Spanish, and other languages to be able to get to the people who actually eat
higher fish than the national median to be able to get the message out in their
language that they best understand, to be able to do that.
We
are going to be looking at doing some of those same things because the
important thing is to be able to have something which then helps generate the
various different ways in which the message can go out, you know, press, consumer advisories by states,
pamphlets we put out, pamphlets states put out.
That
is going to be where taking that message and putting it into real terms is
going to make the difference.
DR.
MILLER: Dr. Scherer.
DR.
SCHERER: Just a few minutes ago there
was some discussion about the advisory starting off with, "Do not eat
shark, swordfish, mackerel," and so forth. There is a phenomenon known as primacy and recency meaning that
when we are hearing
information, we tend to remember the
first and the last.
So,
it would seem to me that some attention really needs to be given to how the
advisory is organized, because it seems to me that starting out with "Do
not eat" says that's the most important part, and if that is what we want
people to remember, that is the part of the message they will remember.
On
another topic, thinking about--and I keep going back to the idea of the
behavioral, because it seems to me that that is really our bottom line. If people go away from this being confused
because of the complexity of the message, as simplified as it is, we still
haven't succeeded, and I wonder why you haven't gone to something like--I am
looking at the Minnesota one that is here in front of me--that gives the simple
behavioral rules to follow when you are interested in consuming fish.
Most
people, most of us have very simple behavioral rules that we follow. When you go to
the grocery store, you don't go through
all of the cereal reading the labels to decide what you want. You have a very simple behavioral rule what
you are looking for, and it is probably a particular brand.
So,
I wonder if the kind of structure that the Minnesota one uses, that is giving
those very simple behavioral rules would not serve a majority of the people
better than a longer narrative kind of description.
Secondly,
it seems to me that we have to keep in mind, and some of you hinted at it, that
all the consumers aren't the same. Some
want those very simple behavioral rules.
Other people do want more the arguments about why should I follow those
behavioral rules, and still others in this room want data.
So,
the levels need to be there to the extent possible, and it seems to me that you
were mentioning the web, that despite the fact that we could argue that the web
will not serve most consumers, there will be consumers that want that depth of
information, and it should be available on
the web.
So,
I think the kind of linkage between the levels of message, in fact I would even
include the web link right in the message, so that people who want more
information can go and get that message.
But
I guess my real question is whether you have given some thought to trying to
come up with a behavioral structure of a message here is the kind of advice
that is given specifically.
This
is talking about if you eat two to three meals of fish per week, they can be
from this group or this group.
DR.
MILLER: Dr. Dwyer.
DR.
DWYER: Thank you. I share Dr. Russell's concern about portion
size, and I think it would help if all government materials used the same
portion sizes. I know FDA, USDA, and
other agencies sometimes use different ones, so we have to get on the same page
particularly in the same advisory on a portion size, but it should be uniform
with what other government agencies are
doing.
It
seems to me there are four forks in this advisory. The first is are you pregnant or lactating or a young child, and
that M.D./Ph.D. guy that you were talking about would go and he could eat all
the fish he wanted, but if the answer is yes, then, the next thing is this
business of no big fish, the four big ones.
I
think in the previous two or three days we spent on this, we talked about
common names, and there are common names for some of them, and they are not in
this. I imagine you will tell me that, well, this is for the
nation and therefore the common names change from one place to another, therefore, we won't put the common names in,
but it seems to me if it's consumer communication, you are going to have
to, so it's no big fish is the second
fork in the road.
Then,
it seems to me--maybe I am still confused about this advisory--that then there
is a fork--back to this behavior stuff that Dr. Cliff was talking about--I
don't think most people really
call their local health department and
check about advisories, so you have to have a rule for those lazy people like
me.
That
would be I think you have said it's no more than 6 ounces--if you don't know in
the advisory--it's no more than 6 ounces of game or sport-caught fish. Right?
DR.
SCHERER: Right.
DR.
DWYER: Then, the last fork in the road
is this one on variety, and it's something, 12 ounces of variety of other fish
a week. The problem I have got is that
I am not going to do that. Now,
hopefully, I am not going to get pregnant either.
[Laughter.]
DR.
DWYER: I am not going to do that. I want advice about the fish that I eat, and
the fish I eat unfortunately are those available in cafeterias, and it tends to
be something, I can't tell what it is because it is covered with mayonnaise,
but it is probably some kind of tuna fish, and it is probably like tuna fish.
So,
I want something more specific than that, that variety message there, because I
am not going to change my consumption.
I want to know what I am going to do within the consumption. I think it is highly unrealistic to think
that we can change people's consumption to orange roughly or to something else
away from these other fish.
So,
the common names, the serving size, the fact that people don't mix things up
even though we want them to, the issue of too much verbiage. If you think about it, the Ten Commandments
are about a third or less or maybe a tenth of the list of this advisory, not
that people follow that behavior either.
[Laughter.]
DR.
DWYER: Then, the final issue about
there are other groups and other agencies of government. Certainly I don't want to hang crepe around
fish, but the point is I don't think that FDA's first mandate is to promote
fish. I think the first mandate it to
promote the public health, and in this specific case, to avoid a contaminant,
so I am more concerned about that than
I am these other things.
I
think other folks and other parts of the government and other kinds of advice
are going to get that larger and important message as well out.
MR.
PENDERGAST: Thanks.
DR.
MILLER: Dr. Waslien.
DR.
WASLIEN: I follow on what my colleague
said, but I am not all together sure that the message gets out that not
everyone in the household should drop fish.
The first point doesn't say that for everybody else it is okay, it just
says for women.
I
think that one of the comments that was made even by the group talking about
the focus group presentations says, well, then, we have dropped fish, and they
haven't dropped it just for the woman or even for the children, they are
dropping it for everyone.
What
made me also react is, you know, this Washington Post made a comment that the
Bush Administration is changing the regulations on
pollution, and it says in there that
the mercury is a threat to public health, to all public health, especially for
children and mothers, but that means it's a threat to everybody else, too.
So,
the message gets out that mercury is bad and you shouldn't eat fish. That is for everyone. In fact, all of us who didn't eat fish last
night were part of that group.
The
second group that I want to identify is my own constituency, the Pacific
Islanders and Asians that are present in Hawaii. For Pacific Islanders, fish is it, there is no chicken, there is
no meat.
I
spent a month in Micronesia and tuna is it, it is the only meat source
available, and we need to look at that group, as well as Native Americans, as a
potential message that has to be delivered.
The
third point is, is there some way
for--and I know this isn't a policy
meeting--that industry or food stores or restaurants can be involved in this,
or if they should, because that
is always a question, of identifying
the low mercury fish for their public, because when you eat in a cafeteria
line, you don't know what the fish is, but I don't know how that message can be
set up and that is not the topic of this meeting, but certainly there will be
industry people who follow up on that and identify the low mercury fish for us
hopefully.
MR.
PENDERGAST: If I could add something to
your last thought, that is somewhat the thoughts that we had on implementation
is how do you get the message out and where do you get the message out.
Some
of our thoughts include working with grocery retail chains, working with
restaurants, and even working within our own agency and what we serve our
senior executives at their annual dinner, they had a choice between--was it
steak and swordfish on there--so we have a lot to do in terms of how do we get
the message out.
In
this case, it is caterers, and those are the things that we will be looking at
and considering as we do the implementation step.
DR.
DOWNER: How many people chose the
swordfish?
[Laughter.]
DR.
ACHESON: Can I just respond to the
issue of subpopulations? I don't think
you can answer your question about swordfish, maybe no data.
One
of the things that we recognize is that we are striving to develop a national
advisory. The studies out of NHANES and
CDC have told us on '99 to 2000 that 7.8 percent of the population had mercury
above the RfD.
One
of our goals at FDA, working with EPA, is to better identify who these people
are. The NHANES data isn't powerful
enough to give us a really good insight as to who these people are, what they
are consuming, what their habits are.
Some of them who are above the RfD profess not to eat fish at all, so we
are dealing with other things, as well.
As
we move forward on this, one of our goals at FDA is to develop programs to
better
identify who this susceptible
population is ethnically, et cetera, geographically, so that we can develop
targeted advice.
This
is a theme that has come up from a number of the committee members of should we
target some people more than others, and it is our intent to try to develop
those data, so that we can move in that direction, but frankly, we are not
there yet, but it is one of our goals.
DR.
MILLER: Did you want to make an
announcement about something, Johanna?
DR.
DWYER: No, I wanted to ask a question.
I
wondered if you could, Dr. Acheson, just what you were talking about with the
percent above a certain level of mercury in the blood.
DR.
ACHESON: I am referring there to the
NHANES work.
DR.
DWYER: What is the variability there,
is there just one measure of serum or blood mercury that they have?
DR.
ACHESON: I believe so, one measure
per person, I believe that is what it
is, but obviously, those data--
DR.
DWYER: You could only get cells,
right? You can get like age, sex cells
or something?
DR.
ACHESON: You can get broadbrush strokes
on did you eat fish in the last 30 days, but we are not getting information on
what kind of fish was that, do you eat sports-caught fish.
DR.
DWYER: Are you revising those
questions, those items for the 2005 survey?
DR.
ACHESON: Yes. That is part of where we want to go, but that is not going to
give us answers until 2007 or 2008. I
am a little more anxious than that.
DR.
APOSHIAN: There are people in the
audience that can answer Dr. Dwyer's question as to how many blood samples were
taken, there are people that were involved in that study in the audience.
DR.
MILLER: Why don't we have a break and
then we will come back to the discussion.
I think the discussion here indicates exactly how complex
the situation is. That is what I heard not only from members
of the committee that the advisory is too complicated, that it is not
complicated enough even from the same person.
I
might point out to Johanna that the debates over the Ten Commandments have
continued and maybe it's too simple.
DR.
DWYER: Thank you, Dr. Miller.
DR.
MILLER: We will come back in about 10
minutes.
[Break.]
DR.
MILLER: Unless there are some vital
issues that members of the committee want to raise to the presenters, I would
like to move on to the public comment section of the discussion on
methylmercury.
DR.
ACHOLONU: I have a comment to make.
DR.
MILLER: Yes, of course.
DR.
ACHOLONU: Thank you, sir.
I
am compelled to make a comment about this.
I looked through the list of mercury levels in various fish presented to
us yesterday, and I
anxiously went through to see the fish
called codfish, c-o-d, codfish, and I didn't see it here.
This
is a sort of a follow-up question or comment to Dr. Waslien's, who comes from
Hawaii. This fish is eaten a lot by
people from the Caribbean Islands and people from Africa, and as a matter of
fact, this fish is being shipped from Norway, and many of the Africans here eat
it almost every day, and I find that it is not on the list.
I
am concerned about it. Could we be told
if any examination has been made of this to find out if it has a high level of
methylmercury, because not too long ago, in Houston, Texas, some people ate
this and it caused some death, and which I know.
Forgive
me for bringing this into discussion. I
would like this to be addressed, where does codfish stand with respect to
mercury level content.
DR.
MILLER: David.
DR.
ACHESON: Yes, Dr. Miller, with
pleasure.
Again,
to reiterate, the data that I presented yesterday and the new data versus the
old data is a subset of the total information that we have in our possession.
That
table was constructed to compare the recent assignment of the 12 fish with the
old data on those same 12 fish. We have
a lot of data on other fish that are not in that list of 12 including codfish.
I
refer you to the latter part of your folders where there is a copy of the
exposure assessment, which actually on Table 2, I believe, lists a lot of the
other fish data that we have. I just
took a quick look at it. I think the
mean mercury level on codfish was 0.143.
So,
please don't assume that that list of 12 is all that we have data on. Hopefully, I made that clear yesterday, but
obviously, failed to do so. We have a
lot more data and we use it.
DR.
ACHOLONU: I used the word
"codfish." It is called
stockfish, s-t-o-c-k, stockfish. Some
people say that stockfish may be a kind of codfish,
it is really not codfish, called
stockfish.
Also,
we have this codfish that is salted fish eaten by the Caribbean people. They have what they call aki, salted fish,
and it's a form of this stockfish, so you may want to find out if stockfish is
the same as codfish.
DR.
ACHESON: We would have to look into
that as to exactly what stockfish is.
We will have to ask a fish expert.
DR.
MILLER: This is one of the big problems
with this, that not only are there different names for the same fish in
different areas, but even there are different fish that have the same name. Halibut in one part of the world is not the
same fish as halibut in another part of the world.
It
is really an incredible task, and I think that compromises are going to have to
be made between the complexity of precision and the ability to make these
things understanding for the bulk of the population we want to reach.
Public Comments
We
now turn to the public comment part of this meeting having to do with
methylmercury. Before we do, there are
a couple of administrative issues.
First,
I have been asked to read the statement which you have heard before in other
areas of discussion, but in order to get it in the record and to remind each of
the speakers that they have to fulfill the transparency requirements of our
rules for this committee
Both
the Food and Drug Administration and the public believe in a transparent
process for information gathering and decisionmaking. To ensure such transparency at the open public hearing session of
the Advisory Committee meeting, FDA believes that it is important to understand
the context of an individual's presentation.
For
this reason, FDA encourages you, the open public hearing speaker, at the
beginning of your written or oral statement to advise the committee of any
financial relationship that you may have with the sponsor, its product, and its
known direct competitors.
For
example, the financial information may include the sponsor's payment of your
travel, lodging, or other expenses in connection with your attendance at this
meeting.
Likewise,
FDA encourages you at the beginning of your statement to advise the committee
if you do not have any such financial relationships. If you choose not to address this issue of financial
relationships at the beginning of your statement, it will not preclude you from
speaking, but I encourage you to do so.
The
second issue is to remind you that we have a very tight time schedule and we
are going to stick to the time required.
Most of the speakers have five minutes.
A few have asked for and we have decided to allow them to have eight
minutes, but whatever the time that has been assigned, please keep to your
time, so that we can finish this up.
The committee has a long discussion ahead of it afterwards.
Also,
I would ask the committee to try and
keep your questions for these public
speakers short and to the point of the discussion rather than trying to bring
up other issues that we have already discussed or we will discuss later on.
The
first speaker is Susan West Marmagas.
MS.
MARMAGAS: Good morning. My name is Susan West Marmagas and I am the
Environment and Health Director with Physicians for Social Responsibility.
In
keeping with the request of the Chair, I have no, and our organization has no,
financial relationship with the sponsor of this meeting or the advisory.
It
is a pleasure to be with you this morning.
Physicians for Social Responsibility is a national organization
representing over 28,000 physicians, other health providers, and concerned
citizens.
We
work really on two fronts. One is we
involve and educate the medical profession about a whole set of issues related
to environmental health, of which mercury in fish is one, and we
also are involved in protective,
precautionary public health policy work at the state and national level, and it
is really from that perspective that I speak to this committee this morning.
We
appreciate the opportunity to express our views. We were involved in the stakeholder meeting in July with FDA and
EPA and have been closely following this issue because it is such an important
public health issue and it is so important for clinicians. I am going to speak a little bit about the
role of the clinician and the importance of advice for them as I get further
into my comments.
We,
however, are deeply concerned about the advisory that is put forward this
morning to you to consider. We think
that it's the status quo that FDA has put forward and it really gives false
assurance to the American people that this issue of fish--we think it is false
assurance on what is really safe in fish.
Therefore,
I am going to speak briefly on six concerns, criticisms, recommendations of
this
advisory and provide some guidance to
you as a committee about how you might address those concerns.
The
first, and we heard a little bit about that this morning, is the issue of
science. We know that a credible and
health protective fish advisory must have a foundation in public health
science.
In
the case of methylmercury, any advisory must be based on the EPA RfD, and we
know that that is 0.1 micrograms per kilogram of body weight per day. As you know, the National Academy of
Sciences endorsed this RfD in its 2000 report, calling it "scientifically
appropriate level for the protection of public health."
In
recent months, FDA has indicated that it will adopt and rely on the EPA
RfD. However, the RfD is clearly not
reflected in the draft fish consumption advisories before this committee.
We
are concerned and baffled why the RfD is not being followed in this case and
being met, and even yesterday, Dr. Carrington, in speaking to
this committee, acknowledged that the
exposure assessment clearly indicates that the only way to ensure that 98
percent or more of the population remains below the RfD is to limit consumption
to 6 ounces of a variety of fish--this is minus the high risk fish--or to limit
consumption to 12 ounces of the low variety fish.
So,
therefore, we don't understand why this RfD is not being followed. We think it is both misleading and
irresponsible of FDA not to follow and meet the RfD and we urge this committee
that the FDA should do that in this advisory.
The
second area I want to talk about is children. In this new advisory, parents are
urged vaguely to feed their children portions that are smaller than the 12
ounce recommended amount. What is
"smaller"? We need to
actually and I think we are able to think about how children are not just
little adults and to model what is actually safe for children. We do this in other areas of child
protective policy, let's do it with fish.
Why
has the agency not consulted with
pediatricians, the American Academy of
Pediatric experts who know how to model to protect children, and we would
encourage that the FDA do that, because we believe that you can develop a
formula for children's consumption that begins with the reference dose and
accounts for the child's body weight and age and their neurological
development.
You
might look at a life stage approach, and we would encourage the FDA, we
encourage you to consider asking FDA to do this, so that we can give more
specific guidance to parents on protecting children.
The
third area I want to address is tuna.
Here, we believe very strongly that while the advisories note that
canned albacore tuna is higher in mercury than canned light tuna, they are
unexpectedly soft on this point. In
fact, FDA's own new testing of methylmercury levels in canned tuna shows that
albacore may contain up to three times as much mercury as light tuna.
FDA
must make this distinction clear to the American public. In addition, there is no
clear guidance on canned tuna
consumption. Eleven states now advise
pregnant women and children to limit their consumption of canned tuna. We need to now do this at the national
level. We need to provide federal
guidance on the issue of tuna.
The
fourth issue, and I think the one nearest and dearest to the heart of my
organization that represents clinicians, is that we are very concerned that
there is conflicting and unclear advice, medical advice on how to deal with
this issue.
The
advisory needs to clarify the potential effects. It equates so-called "minor delays" with medical
condition, but it doesn't clearly talk about what that link is, so these
so-called minor delays that we believe are
serious are sort of equated with medical problem. There is a distinction that needs to be made in this advisory.
In
addition, the advisory assumes that health care professionals are prepared and
ready to answer questions from their patients.
It talks in
this document about if you think you
have been exposed to mercury, immediately seek advice from a health care
provider.
We
believe that in order to avoid unnecessary concern from parents and to prepare
health providers to really be part of the solution, that FDA needs to develop
tailored and substantive guidance for clinicians.
We
recommend that FDA reconsider the following statement, "If you have
questions or think you have been exposed to methylmercury, see your doctor or
health care provider immediately."
We
question this message for several reasons.
First, the advisory has previously implied that everyone is exposed to
some level of mercury since it is ubiquitous in our environment, so are we now
saying that everybody should seek medical advice? We need to clarify that point.
Second,
health care providers are not prepared to answer questions from their patients
without clinical guidance from EPA, and we believe it is incumbent to provide
clinicians with more
details on what they should offer to
their patients.
Finally,
I want to conclude on my last fifth and sixth points, and we have heard this
earlier today, we need to give an empowering message to the public and
therefore, we need to talk about the low-level mercury fish. That information is not in here, and that is
a great opportunity to say avoid these, these are where you can focus your
attention. We think it is very
important to highlight the low-level fish in this advisory.
Finally,
and I think this is very important, in one of the initial drafts of the
advisory, there was a statement that said, "There is no harm in eating
more than the recommended amount of fish and shellfish in one week as long as
you do not do it on a regular basis."
This
doesn't work for pregnant women and we strongly recommend that in here, it
says, "Pregnant women should be advised to follow the guidelines at all
times, that at all times during
pregnancy, they should reduce their
exposure to fish that are high and moderately high in mercury."
DR.
MILLER: Ms. Marmagas, your time is up.
MS.
MARMAGAS: Thank you.
We
need to protect children and the fetus in their vulnerable windows of
vulnerability and therefore all pregnant women throughout all of pregnancy
should follow these guidelines.
I
thank you for your time.
DR.
MILLER: Any questions that need to be
asked?
If
not, we will go to the next speaker, Dr. David Wallinga. You have eight minutes.
DR.
WALLINGA: I am Dr. David Wallinga. I am a physician with the Institute for
Agriculture and Trade Policy in Minneapolis, Minnesota.
Thank
you very much to the committee for allowing me to speak. As with the previous speaker, my
organization has no financial relationships with the sponsor of this meeting.
I
speak with many different hats including
having carried out training around how
physicians can give advice on fish consumption to almost 1,000 health
professionals over the last couple of years.
I
also come with the hat of having helped prepare this consumer advice that we
distributed to you, which is Minnesota-specific, but I think it has some
interesting lessons, and then, thirdly, as a resident of Minnesota, which I
believe has the most fish advisories of any state, most of those being for
lakes, which are not mentioned in the advisory, by the way.
Also,
somebody had raised the issue of the states having to distribute advisory
information. Minnesota prepares
advisories, but its $35,000 a year budget for actually distributing it was cut.
So,
I wanted to applaud the committee and FDA for a couple of things, first,
renewing their testing program and generating more comprehensive data, and also
for trying to work jointly with EPA to come up with a single piece of advice.
But
I did have several concerns that are going to be echoing those of the previous
speaker.
As a physician, primarily, I want to
point out some ways in which this advisory may make it harder for physicians to
practice in a way that is consistent with their oath to do no harm.
First
of all, relative to serving sizes, I agree that the draft advisory is confusing
on this score, and I wanted to just talk a little bit about Dr. Jane
Hightower's data. She gave me
permission to use some of this information, and she did this study that you are
familiar with, looking at 123 patients of hers from a practice that sees about
700 patients a year.
The
patients in that sample had a number of fish meals that ranged from 3 1/2 to
about 50 per month with an average being 18 per month or 4 per week, and they
considered a serving size to be between 5 and 8 ounces. Many of the restaurants they frequented
served fish servings in that amount.
So, I really think that this 12 ounces, whether it is 2 or 3 servings,
it should reflect real life.
I
also noted the inconsistency between the
serving size for the 12 ounces of
seafood and the 6 ounces of freshwater fish, and that should be addressed.
Second,
I wanted to point what I did in this chart was to start again with the
reference dose of 0.1 microgram per kilogram per day for a 60 kilogram woman,
equates with a 180 micrograms of mercury ingested per month, and I compared
that to what the ingestion would be with fairly modest 6 ounce servings of
these species, which is not as much as up to 12 ounces that is recommended, but
is consistent with the advice to only eat one species a single time per week.
As
you see for grouper, orange roughy, Minnesota walleye, canned albacore, and for
those species, they all exceed the reference dose amounts. In addition, just for yuks, for halibut, I
looked at what would happen if you ate it eight times per month or,
alternatively, a one-pound serving, and again you are over.
As
you can see, there is this disconnect between the reference dose and the advice
that is
actually given. I think the Environmental Working Group is
going to talk about this later, but I wanted to just point that out.
Patients
don't eat fish based on just mercury, they want to know which fish are safe to
eat, and they also want to, as was mentioned earlier, they see things
holistically. I don't think this is too
surprising. They want to know the
totality of the fish that they can eat. Although the draft advisory mentions
freshwater species, there is not much concrete advice about freshwater species.
We
attempted to do that in this report. We
had combined information from both FDA, as well as state information data on
PCB and mercury contamination for Minnesota fish.
We
did some others things, too. We had an
expanded Do Not Eat list reflecting our belief that a 0.5 parts per million
cutoff in terms of what people should have, and because many of the species
that have been most recently tested by FDA have elevated levels above 0.5, we
think that the draft
advisory should have an expanded Do Not
Eat list, but I would also point out that in Minnesota, PCB contamination
including many of the low mercury species can result in fish advisories, and we
should say something about predatory fish that are freshwater fish, like
muskies, white bass, large walleye, and large pike.
That
didn't prevent us from starting off telling people what they can eat, and I
think this is a very key point, that people are not confused or scared because
of too much information, rather a lack of specific information, and we tried to
empower consumers to find fish that are safe that they can eat.
We
added in some sustainability criteria that I don't think I will talk about, but
that is what some of the coloring has to do with.
Second
of all or another point is that our advisory seeks to protect everybody, and I
know you are familiar with this graph.
This is from EPA's Children's Report, just depicts the CDC data, and so
that is what a lot of us have been talking
about, but obviously, the advice
doesn't protect wealthier people who tend to be high-end consumers of fish, and
maybe that can't be covered in this advisory, but perhaps this committee should
recommend another advisory.
It
also doesn't reflect concerns for adults who don't plan on getting pregnant,
namely, concerns for their cardiac health and people with cardiac disease.
This
is just to say, again data from Jane Hightower's study showing that a large
percentage of the people that she looked at, and did mercury sampling for, had
blood lead levels that exceeded, in some cases many fold, the maximum
recommended blood mercury levels, and their hair levels were also elevated in
some cases.
What
is this talk about cardiac toxicity, because again the advisory doesn't mention
this at all. The literature about the
cardioprotective effects of omega-3 fats is pretty good, but as the NAS also
pointed out, there is much data from both animals and humans that exposure to
methylmercury
can have adverse effects on the
developing and adult cardiovascular systems and that some research suggests
that these adverse effects occur below levels associated with
neurodevelopmental deficits.
Here
is again some other studies that they have talked about pointing out that just
a 2-fold increase--
DR.
MILLER: Dr. Wallinga, could you
summarize, please.
DR.
WALLINGA: Yes. Let me just skip to the end. So, suggested
changes - serving sizes should reflect real life, that in the upper limit of
recommended fish consumption should be safe.
We should empower patients by telling them what fish they can eat and
don't insult the intelligence of the patients by assuming that it is more than
they can handle.
We
should do more testing of fish that people can eat, and we should also test for
pollutants other than mercury. Right
now I have trouble finding any PCB or dioxin or flame retardant testing for
fish in the FDA website.
Finally,
perhaps we need a separate advisory dealing with cardiac endpoints, so that, as
a physician, we can give good advice to all our patients, and not just those
expecting to get pregnant.
Thank
you.
DR.
MILLER: Any brief comments? Thank you.
The
next speaker, five minutes, is Caroline Smith DeWaal.
MS.
DeWAAL: Good morning. I have no financial ties with the sponsors
of this meeting.
I
am Caroline Smith DeWaal and I represent 800,000 consumers who are members of
CSPI and subscribers to Nutrition Action Health Letter.
We
actually put out consumer education to consumers 10 times a year on foods that
they may want to purchase were very specific, and we have a lot of good advice,
both for nutrition and also for food safety.
We
have been very supportive of this process and we appreciate the work that EPA
and FDA
have done to date. Just bringing the agencies together and
agreeing on common language is progress.
However,
we are disappointed with the final consumer advisory, which I didn't see until
yesterday morning, and in my remarks which are included in this paper, we talk
about three draft advisories, which is what we saw prior to this meeting.
Let
me give you just one example of our concern regarding this advisory. I am going to read the risk message.
"The
FDA and the EPA are advising pregnant women and nursing mothers to eat the
types and amounts of fish and shellfish that are safe to prevent any harm to
the developing nervous system of their baby or young children."
That
may mean something to other people, but I can tell you it doesn't mean a lot to
me, and I think it doesn't mean a lot to the consumers that we are trying to
communicate to. I think it is a double
positive to communicate a warning message
and it really doesn't work.
In
addition, I think one example that shows perhaps the way we got to that kind of
message as being a risk message, which it isn't, may be in some
misunderstandings of the people drafting it.
For
example, Dr. Acheson was quoted in the Washington Post this morning, saying
that the advisory was implicit in telling at-risk women to eat more than 4 to 6
ounces of tuna per week.
I
mean in a consumer advisory, we cannot be implicit, we cannot have implicit
messages. If that is an important
message to at-risk women, it needs to be explicit.
I
have a couple of pieces of advice. We
believe that the advisory needs significant redrafting in order to be
effective, and I hope that the Food Advisory Committee can make some
recommendations that will help get this advisory out quickly, but in a form
that is much more effective.
First
of all, we would urge you to
recommend to Commissioner McClellan
that he convene a roundtable of experts from consumers, public health
organizations, and the seafood industry early next year to make recommendations
on the advisory.
You
might want to think about this as a stakeholder focus group. They are doing focus groups with average
consumers. Perhaps they should do one
with stakeholders and get very specific ideas for making improvements.
Frankly,
I think we could--I have been working on this issue since 1991 when the
National Academy of Sciences first criticized FDA's standard for
methylmercury--I think that I could sit down with members of the seafood
industry and come up with a clearer, shorter, and more effective message.
I
think you also might want to recommend that they think about more than one
advisory. There is the advisory to
pregnant women, but there should be a separate advisory to the parents of young
children.
Children
eat--anyone who has children knows this--if a child likes a food, they eat it
all the time. If they like tuna, they
are going to want tuna five days a week.
We need to be very explicit with consumers, and in CSPI's Nutrition
Action Health Letters, we actually published a list that has the weights of
children and how much is safe to eat for canned tunafish.
Again,
these numbers need to be redone on the basis of the new data that FDA has
developed, but giving parents very specific information about what is safe to
eat I think is quite important.
My
third recommendation to the Advisory Committee is to ensure that the final
advisory reflects the science. We heard
yesterday from Dr. Carrington in the exposure assessment that really, the 12
ounces recommendation only goes to the seafood that contains low amounts of
mercury, and not to many of the fish that are on the list.
The
better recommendation may be 6 ounces of seafood, not 12 ounces. In addition, the names of the fish aren't
clear. My understanding is
tilefish is actually frequently sold as
golden snapper. So, getting the actual
correct names of the fish in the advisory is very important.
Again,
I think a focus group of experts from the seafood industry and consumer
communities might be able to work out some of these issues if it can't be done
at FDA.
DR.
MILLER: Caroline, can you finish up,
please.
MS.
DeWAAL: I can. finally, we would like to bring to the
committee's attention another advisory which is in use in California. This is in your packet. I would urge every member of the committee
to look at it.
This
is actually at point of purchase when you buy seafood in California, and it
mentions salmon, shrimp, and scallops as the low risk seafood, the things that
people can eat a lot of very safely, but this has a lot of good information and
the information that the Advisory Committee has been asking for. So, if you look at this in our packet, this
will I think also give you some ideas
of how to do the advisory more
effectively.
Thank
you very much.
DR.
MILLER: Thank you, Caroline.
Any
questions for her? Thank you.
The
next speaker is Carol Stroebel from Children's Environmental Health
Network. Five minutes.
MS.
STROEBEL: Thank you. Thank you for this opportunity. My name is Carol Stroebel and I am
representing the Children's Environmental Health Network, and although I am not
a scientist myself, I am honored to be working with the nation's foremost
researchers and clinicians in the field of children's environmental health
through their participation in the Network.
In
terms of financial disclosure, my sole relevant financial relationship is the
compensation I receive from the Network from the work I do for the Network.
The
Network was created to promote the incorporation of basic pediatric principles
in policy and practice. My written
statement includes
these principles in detail, but I will
summarize them now simply by urging you to always keep in mind that children
have unique vulnerabilities, susceptibilities, and exposure.
We
have learned from sad experience that exposures to environmental toxicants that
result in little or no harm to adults can lead to lifelong harm in
children. The Network strongly urges
you to help assure that these principles are applied in all FDA actions and
policies, especially those that relate to methylmercury.
We
know that methylmercury is a potent developmental neurotoxicant. Thousands of U.S. children are estimated to
be at risk from exposure to mercury, an estimated 60,000 infants each year from
in-utero exposure alone. We have a
responsibility to prevent these risks, and the FDA has a substantial
responsibility in this regard.
Certainly,
what FDA and EPA and other government agencies communicate to the public is
vital, and I will speak on that momentarily, but these decisions must also be
made in the context of
two paramount issues.
One
is that standards that are not adequately health-protective of children will
place children at risk. Dietary advice, while vital, is, by itself, inadequate
to eliminating the risk of methylmercury, and prevention of risk begins with a
better understanding of the sources and levels of exposure. We cannot successfully undertake the task of
keeping mercury out of our food chain if we do not monitor our foods for the
presence of mercury.
Thus,
the Network strongly urges the FDA to adopt and enforce the NAS/EPA standard
for the safety of methylmercury in fish.
We have been heartened by the recent joint EPA and FDA discussions on
mercury and we are hopeful that they will result in coordinated and
health-protective standards for children.
We
commend the FDA for undertaking some increased monitoring of mercury levels in
fish. However, we need to undertake a
systematic monitoring of mercury in fish and in people, as
part of a coordinated governmental
effort to protect people from the harmful effects of mercury.
In
addition, other foods with known or potential mercury contamination must also
be tracked and analyzed, so I want to take the opportunity today to mention
another issue I hope that the committee considers.
There
is a recent analysis of baby foods by government agencies in the United Kingdom
and it found a quarter of the samples contained mercury and that the average
level of mercury in those foods was double that found three years earlier, and
some babies were found to be consuming twice the amount that the U.S. EPA would
deem safe for adults.
The
Network communicated to the FDA earlier this year and asking for them to
undertake an analysis of baby foods.
Unfortunately, the Network has yet to receive a response, so we request
that you consider recommending that FDA also monitor these foods for mercury.
In
terms of the consumer advisories, our
written comments also refer to the
three draft advisories, not to the fourth version that we just saw this
morning.
The
Network commends the FDA for the efforts it has undertaken to improve its
consumption advisories, and we thank the Advisory Committee for the great
leadership it has shown on these efforts.
We
wish to associate ourselves with the testimony and the materials developed by
Consumers Union and by Physicians for Social Responsibility, and we urge the
committee to carefully consider their proposals.
In
brief, we urge that all consumer advisories on methylmercury in fish and
seafood reflect the following concepts:
First
of all, the advisories must be based in science; they should define what
science indicates is a "safe" dose and provide advice that would keep
consumers from exceeding the RfD. None
of the draft advisories do so.
The
advisories should assure that all
subpopulations at risk are
targeted. Certainly, women of
childbearing age must be targeted. But
so must other groups at risk, particularly children. The draft advisory does not focus on children and is not specific
enough for children. The draft advisory title, for example, says advice for
women of a certain group about children.
Children
can safety consume far less fish than adults, and the advisories must clearly
make this point, and advisories must make clear that even one-time high-end
consumption - a spike in mercury exposure - could be harmful to children.
Some
advisories have mentioned a specific number of ounces that would be okay for
adult consumption, but then used vague term, such as "smaller" when
providing guidance related to children.
DR.
MILLER: Ms. Stroebel, could you
summarize.
MS.
STROEBEL: Sure. The advisories should provide more
information about different fish and seafood varieties, so that consumers are
not given the impression that all
species off the Do Not Eat list are equal, and the advisories should put health
first even if it means a message to eat less tuna rather than a misguided
statement that you can safely include tuna as part of your weekly fish
consumption, which is not the case clearly for some part of the population.
Thank
you very much.
DR.
MILLER: Thank you.
Yes.
DR.
APOSHIAN: I think your statement of
60,000 children at risk is extremely conservative. We have been all handed a copy of a peer-reviewed paper from the
EPA group co-authored by Mahaffey, Clickner, and Joseph.
In
the summary on page 4, and I will just read the statement, "Based on the
distribution of blood mercury concentration among the adult female participants
in 1999-2000 NHANES and the number of U.S. bursts in 2000, more than 300,000
newborns each year in the United States have been exposed in-utero to
methylmercury concentrations higher
than those considered to be without
increased risk of adverse neurodevelopment effects associated with
methylmercury exposure."
The
article, peer-reviewed journal by the EPA, that I think should not be ignored.
DR.
MILLER: Thank you.
The
next speaker is Robert Califf [ph] from the National Fisheries Institute.
MR.
CALIFF: Good morning. I would like to thank the Food and Drug
Administration and the Environmental Protection Agency for the opportunity to
address the Food Advisory Committee this morning.
I
represent the National Fisheries Institute, an Arlington, Virginia based
nonprofit trade association representing the commercial fish and seafood
industry, and we have no financial connection with the sponsors.
NFI
wishes to commend the Food Advisory Committee for its recommendations provided
to FDA at the conclusion of the committee's meeting in July 2002. We also wish to acknowledge the work
undertaken by FDA in response to the
recommendations and the efforts by both agencies to develop a joint advisory
for mercury and fish.
In
2002, NFI made a presentation to the Advisory Committee with the assistance of
Dr. William Connor of the Oregon Health and Science University. Dr. Connor provided a review of the
scientific literature that shows the positive influence that fish and seafood
has on nutrition and health status of U.S. consumers.
Dr.
Connor's review included the large body of scientific research on the
cardioprotective effects of N3 fatty acids found in fish and the essentiality
of N3 fatty acids in the development of the brain and retina during fetal
growth and in babies after birth.
In
addition to this body of research, new information is emerging on N3
deficiencies and depression. In 2001, a paper was published in the Lancet by
NIH researcher Dr. Joe Hiblin [ph], who observed that mothers transfer DHA to
their fetuses to support neurological development during
pregnancy, and further concluded that
mothers without sufficient intake can become depleted of DHA, which may
increase their risk of suffering major depressive symptoms in the postpartum
period.
I
have begun my comments by mentioning this information to make the point that
fish is not like tobacco or alcoholic beverages that carry risks with little or
no health benefits to those who use them.
We
believe the benefits of fish consumption must be highlighted in explaining the
mercury issue. Advisories should be
educational messages that are easily understood and balanced regarding the
risks and benefits associated with fish consumption.
If
they are not, we believe consumers will be confused, causing them to deselect
fish from their diet. This would be unfortunate and perhaps harmful to
consumers because they would lose the health benefits associated with fish
consumption.
There
is some evidence that the release of the existing fish advisory and media
coverage
surrounding that release has already
resulted in the decrease of consumption amongst pregnant women.
Dr.
Emily Oken of Howard Medical School and colleagues published a paper this year
that showed an association between the release of the advisory and reduced
consumption of tuna, dark meat fish and white meat fish alike in a cohort of
2235 pregnant women in Massachusetts.
The
authors concluded that the public health implications of these changes in
consumption remain unclear because fish may confer nutritional benefits to mothers
and infants.
The
study suggests to me that women may not understand the dietary changes may not
be needed if they are already avoiding fish with the highest levels of
methylmercury and are eating a variety of fish on average in the amounts
recommended.
There
has been considerable discussion about whether the existing advisory goes far
enough in warning women of childbearing years about methylmercury and making
recommendations about fish
to avoid.
I
think some context can be provided by looking at what some of the other
developed nations around the world have done.
In Canada, the recommended limit for swordfish, shark, fresh and frozen
tuna is one meal per month for young children and women of childbearing age. The Canadian advisory notes that this
restriction does not apply to canned tuna.
In
Australia and New Zealand, the current advice for pregnant women is to limit
the consumption of shark, swordfish, and six other species to four portions per
week. It also indicates that other fish, including canned tuna, can be consumed
as often as desired, but consumers should eat a variety of fish.
The
health agencies in Australia and New Zealand have said that they are reviewing
this advisory in part due to the establishment of a new WHO tolerable weekly
intake that is intended to protect the developing fetus. The WHO's tolerable exposure level is a
little more than double EPA's
RFP.
In
June of this year, a news article in Japan indicated that the Japanese Ministry
was advising pregnant women not to eat swordfish and alfonsen [ph] more than
two times a week and to limit consumption of shark and sperm whale to no more
than once a week.
Interestingly,
the article indicates that the Ministry said the consumption of fish does not
pose a health problem to pregnant women, but despite that effort by the
Ministry, the message conveyed to consumers resulted in a drop in the sale and
price of alfonsen sharply.
DR.
MILLER: Could you summarize, please.
MR.
CALIFF: Thank you.
In
regard to the advisory itself, we would like to first commend the agencies on
the work they have done to develop the joint advisory, to test it, and then to
rework it based on focus group responses.
We
ask that agencies ensure the advisory provides adequate reassurance to
consumers that
fish is a healthy food choice that
should be maintained in the diet.
Finally, we urge the agencies to continue the careful process they have
begun by testing the version of the advisory that they propose to use including
the evaluation of the impacts of the advisory after it has been issued.
Thank
you for your time.
DR.
MILLER: Any questions or comments? Thank you.
The
next speaker is Dr. Ned Groth from Consumers Union. Eight minutes.
DR.
GROTH: Thank you very much, Mr.
Chairman.
Consumers
Union is a not-for-profit testing and publishing organization supported by
subscribers, of which we have about 5 1/2 million.
For
those of you who don't know me, I am a biologist. My specialty is environmental health. I have been at CU for 24 years doing risk analysis, risk
assessments, scientific research, and policy advocacy and risk communication on
food safety and environmental health issues.
In fact, I have been
dealing with issues like this since
Sandy was the head of the Bureau of Foods.
We
have a considerable amount of experience to share with you. I have distributed a written statement. I am going to highlight some key elements of
that in the context of what I hope this committee can do today to help move
this process forward.
We
think the FDA and EPA have come a long way, but there is still a lot of
improvement needed in three particular areas I want to call to your attention
and hope you will concur with.
One
is the advisory has to be based on sound science in terms of defining what is a
safe intake. As we have heard in many
ways, it is not at this point. It
simply cannot say that it is okay to eat more fish that contains mercury that
will give doses above the reference dose and call that safe.
The
reference dose is a definition of safety in that it means exposure below that
is reasonably certain to pose no risk of harm, but
above that, it is not certain it is
harmful, it is just we are in the gray zone between knowing there is no risk
with scientific reasonable certainty and knowing there is a risk.
The
gray zone is only a factor of 10Y in this case. It is not a huge safety factor.
So, if you are talking about exposure that could be 3 or 4 or 5 times
above the RfD, which could happen with some of the fish meals that people are
likely to be eating, we are way too close to the level where we know harm is
likely, and we have to stick to a reasonably scientific and well-vetted
definition of safety.
The
FDA has adopted the RfD, but it isn't reflected in this advice, and it has to
be. So, I think that is point 1.
Point
2 is about populations at risk and several people have already addressed
that. I endorse what Carol Stroebel and
David Wallinga and others have said about targeting advice to other groups we
know are at risk, not merely pregnant women.
Children as a separate group, yes; high-end
fish eaters, I want to say some more
about that.
I
have looked at the data on fish consumption from figure 2 of the Carrington and
Bolger paper, and tried to read that graph.
Right around the inflection point is where it gets interesting, but it
appears that about 2 1/2 percent of the population consume more than 0.6 fish
meals a day, which would be 4 fish meals a week, and if you go down to 0.5, it
is about 5 percent of the population consumes half a fish meal a day or more,
which would be 3 1/2 fish meals a week.
When
we consider portion size, which I will, I think it is reasonable to assume that
those people are eating more than 12 ounces of fish a week. That means if we are talking about the
population of the United States, 2 1/2 percent is about 7 million people, 5
percent would be 14 million people. Not
all of the people in the United States eat fish, but it is still a very large
number of people we are talking about who eat more than, and can be reasonably
expected to eat
more than, 12 ounces of fish a week.
I
can just say anecdotally I have eaten more than 12 ounces of fish in a
meal. If you go to Legal Seafood, at the prices they charge, and have a shrimp
cocktail and a plate of scallops, you are getting 20 ounces of seafood by my
conservative estimate in one meal, and that is not unusual especially as
someone mentioned, for wealthier consumers.
There
is an article in the Consumer Reports issue that is out now which talks about
the obesity problem, and one of the factors in obesity is portion size, and one
of the things we have learned about portion size is that people take home from
restaurants a subjective impression of what is an appropriate portion size.
So,
people are now serving much larger servings of meals at home because they get
them in restaurants, and people are eating more, consuming more calories than
was true a decade ago.
I
think the last point I want to make is about the message, and I think this is
the area
where the advisory needs the most
work. I found it very confusing, I
found it scientifically incorrect, and I found it, in many cases,
self-contradictory.
I
think the message is it follows in an FDA tradition of what I call the warning
label approach, which is if something is dangerous, you want to tell people not
to eat it. That leads to a false
dichotomy.
If
it is not dangerous enough to require a warning label, it must be safe, and
that is not the case. Risk is a
continuum and to single out four very high mercury fish and then say in several
ways, and everything else is okay if you moderate your intake, I think is
misleading and wrong.
We
have also learned at Consumers Union that what people want more than anything
else is tell me what to buy, what should I be eating. Telling me what not to buy is one part of the information, but
what people want most is to know what to buy.
If
you look at Table 2 in the handout, and
if you modify that, which I have done,
but haven't done in that one, by including the updated FDA data that were
released for this meeting, there are now about 15 varieties of fish and
seafood, including a large number that are very widely consumed, like shrimp,
scallops, and salmon, that are below 0.12 parts per million, which is the level
of mercury at which, if you consume 12 ounces a week, you will just meet the
RfD.
So,
there are 15 low mercury choices, and if I were to rewrite this advisory at
this point, and, like Caroline, I think I could do it pretty quickly, I would
say, first, choose from this list of fish to keep your mercury within safe
limits, and basically, you could say eat as much as you would like of these
fish and you will be safe. That would
be those with less than 0.12.
Then,
I would say do not eat the four with the highest mercury, put the warning label
in there, and with respect to everything else, I would say don't eat more than
one portion a week. Eat a variety, but
don't eat more than one portion a week
of any of those others because many of
them are moderately high in mercury.
The
one point I might modify in what I just said is FDA, in the Carrington and
Bolger paper, has defined high and low and moderate mercury content. High is above 0.5. I might add to the Do Not Eat list those fish that have above
0.5. There would be three or four other
things to add to the four that are already on that list.
I
think also in terms of specific advice about tuna, it needs to be much clearer
that albacore tuna and fresh tuna steaks are in the moderate, don't eat more
than once a week, and eat only small portions of category.
I
think light tuna fits into the low mercury category especially with the decimal
point refined with the latest data it would be around 0.12, and that is fine,
but you need to be much more specific and give clear advice about not eating
too much albacore or fresh tuna steaks.
I
think that is it, and I would be happy to answer any questions.
Thank
you.
DR.
MILLER: Thank you, Ned.
Any
questions or comments? Thank you.
The
next speaker is Michael Bender, Director of Mercury Policy Project. Eight minutes.
MR.
BENDER: My name is Michael Bender. I am the Director of the Mercury Policy
Project. We are a nonprofit, focused on
reducing mercury emissions and exposure to mercury at the local, national, and
global level.
We
have no financial relationship with the sponsors. I appreciate the opportunity to be here. Like others, I just wanted to express my
appreciation for FDA and EPA getting together and trying to put together a
comprehensive advisory.
It
is also good to see that FDA has gone out and done some canned tuna testing,
some comprehensive testing for the first time in 10 years, and that sort of
came on the heels of our testing of 60 cans of tuna in June of this year, and
we are also glad to hear that they are planning on doing additional testing.
While
this is difficult for people to read, and I apologize for this, everyone should
have a copy of this in front of them, at least the committee members, and I
decided to take a more pragmatic approach than my colleagues, and while I would
second the recommendations to work with the stakeholders and to see if we can
come together and to make some kind of a comprehensive approach that addresses
the issues pragmatically, I wanted to make some suggested changes if you are
presumably working off from this draft and trying to improve it.
The
first thing I would suggest would be simplification, offer more specific
consumption advice for children would be secondly. An approach to the use by the State of Washington, and I will
show you a graph exactly what they do, and also, as other speakers have
suggested, make your recommendation more consistent with the EPA's reference
dose while promoting consumption of low mercury fish and shellfish.
I
would reword the title, Advice for women
who are pregnant, might become
pregnant, nursing mothers, and young children, about reducing mercury exposure
from fish and shellfish consumption.
Straightforward and to the point.
I
don't have a problem with starting out with saying that fish is an important
part of a balanced diet. I think it is
important to continue to convey that message, but the first change would be the
suggestion to eat low mercury fish and shellfish, I don't think this can be
emphasized enough. That would be in the
second clause of the handouts.
The
second change would be, suggestion would be to add albacore tuna, and that
would be both fresh and canned tuna, based on not only the FDA's data, but also
our data, and other data from Consumers Union, the FDA data from 1992, et
cetera.
That
third change would be in No. 2, where there is a recommendation for 12 ounces a
week. I would recommend that in lieu of
any kind of list, that you change that to 6 ounces (one meal) per week of
purchased fish and shellfish.
I
would also, in my next suggested change, move from the Q and A, where we are
for the first time ever addressing tuna in a question and answer, and I would
argue that a lot of people won't get that far, that you need to have a sentence
in No. 2 which, in a positive way, states that you can consume light canned
tuna in moderate amounts or in moderation as part of your weekly consumption.
My
next suggested change, and mentioned by Dr. Wallinga, was in the EPA part of
the advisory where they talk about local streams and rivers at lakes and
ponds. Most of the fish probably comes
from lakes.
I
guess for the children-specific section of the advisory, give examples. For example, a
20-pound toddler can eat 1 ounce of
fish or shellfish per week, a 40-pound can eat 2 ounces of fish or shellfish
per week, and an 80-pound child can eat 4 ounces of fish or shellfish per week.
I
just will quickly go through--I just have two or three slides. This has been mentioned before. There are now 11 states that warn pregnant
women and, in some cases, young
children, to limit consumption of canned tuna.
These warnings started in 1997.
Actually, there is another one, Hawaii is now added to the list.
Not
only do they talk about limitations, but they also note starting in 2000 in
Maine, that women of childbearing age limit to one can of white or two cans of
white. There is a distinction that is
being made. Again, that was based on
the FDA dataset from 1992, a very robust dataset.
This
is from the Washington State Health Department. It's right on their website.
It basically talks about, it follows the EPA reference dose of body
weight per kilogram per day, or I think it might be a little more
stringent. The note I have here is that
it is based on the FDA lumpage of 0.17 ppm, and not the new FDA data, the
average mean of 0.358.
Just
looking at the person's body weight at the bottom, that is where I derived the
recommendation for the children. As you
can see, for a 20-pound child, this would be less than 2
ounces; for an 80-pound child, it would
be 4 ounces.
So,
I think there is some information out there that is available on this.
Secondly,
I just wanted to bring your attention to our canned tuna dataset. As I mentioned earlier, we released our
results in June, and the average we found was about 0.5 ppm, a little bit
higher than the FDA dataset.
The
range was greater. It was from 0.23 to
1.1 ppm. I believe the last time this
committee met, Dr. Aposhian had mentioned that he had tested 10 cans of tuna
and found 1 over 1 part per million.
The industry has also indicated that some of the canned tuna comes in
over 1 part per million.
[Inaudible
comment.]
MR.
BENDER: I am sorry. Yes, the bottom is the light tuna and what
we found--I am glad you mentioned that--the average for the 10 cans was 0.118,
which is very consistent with the FDA's testing both this year and in their
1992 test.
It
is difficult to read this one, as well, but basically, we just did some
calculations if we were to apply the FDA's mean of 0.358 to the different body
weight.
For
instance, a 22-pound toddler eating only 2 ounces of tuna per week with the
0.358 ppm would exceed the EPA's RfD nearly 3 times; a 44-pound child consuming
1, 6-ounce can of tuna with 0.358 would exceed the RfD by over 4 times; an
88-pound child consuming 1, 6-ounce can
of tuna with a 0.358 ppm would exceed the RfD by over 2 times.
A
woman with a typical body weight of 132 pounds consuming 2 cans of tuna per
week with 0.358 will exceed the EPA's RfD by almost 3 times. Also, if the same woman eats only 1, 6-ounce
can with the same ppm, she will exceed the EPA's RfD by over
1 1/2 times.
DR.
MILLER: Could you summarize.
MR.
BENDER: Yes. So, in summary, I guess I would just reiterate many of the points
of my colleagues, and if the committee was at a place
where they wanted to move forward now
rather than suggest revisions for the future, I would suggest that they
consider some of the points not only that I made, but of my colleagues.
Thank
you.
DR.
MILLER: Thank you.
Questions
or comments? Thank you.
The
next speaker for 5 minutes is Dr. Joanna Burger of Rutgers University.
DR.
BOEHM: My name is actually Dr. Susan
Boehm from the New York Academy of Sciences.
I am speaking on behalf of Dr. Burger who could not be here for part of
my remarks, and then I will speak for myself, as well.
Dr.
Burger has no financial ties to either of the funders here.
I
am talking specifically today about a paper that is in publication by Drs.
Burger from Rutgers University and Dr. Gochfeld from the Robert Wood Johnson
Medical School, where they looked at approximately 145 cans of tuna, white and
light. I will present the highlights of
that.
There
are about 12 copies of this paper. It
has been embargoed until publication, but she got permission to distribute it
to the committee, and some of those have been distributed. Then, there is a summary page that is out on
the table that summarizes the findings.
Of
the 123 cans of albacore and 45 cans of chunk light tuna, they demonstrated
there was a much higher mercury concentration in the albacore tuna, on the
order of 3 1/2 times. This is very
similar to what has been seen before.
They
also did these analyses over a number of years, and there is evidence that
there could be increases, that we could be increasing mercury concentrations
over time in cans of tuna.
Also,
there have been some spike years probably due to changes in fishing.
Approximately,
90 percent of the mercury that is in the tuna is in the form of
methylmercury. That is important to
always keep in mind. Twenty-five
percent of the albacore tuna that they tested was over the 0.5 ppm level.
They
recommend that persons who are frequently eating canned tuna could, in fact,
choose light tuna over the white tuna if they were aware of these differences,
and that systematic monitoring of the cans of tuna supplies should be
established, that doing it once every 10 years is clearly not enough if we are,
in fact, seeing increasing levels of over time, and that fish advisories should
always distinguish between the two types of canned tuna.
They
also measured about 9 cans of mackerel, canned mackerel, and found them to have
low mercury concentrations, so that might be something that could be put as a
positive thing, something that could be eaten.
That
is the summary of Dr. Burger's comment.
I
am now going to speak for myself from the New York Academy of Sciences, and I
will disclose that we do have--I work on a project, a large-scale, ongoing
project, multi-funded, but one of our funders is EPA.
Our
work, what we do is we track sources of mercury and methylmercury to the New
York/New Jersey harbor, so we backtrack to every product process that releases
or produces or uses mercury, trace how it is used, released, and produced
through disposal, and look what is getting into the harbor, but the idea of
figuring out ways to step in and keep mercury out of the harbor. That is the background of our work.
I
wanted to sort of echo something that Dr. Dwyer pointed out, that this wording
in the newest advisory really focuses, while it is very important to focus on
women and children, the rest of the population has now been left out, that the
rest of the population is not included or is not specifically included now in
this document.
It
is the responsibility of the FDA to provide the information to the consuming
public, and it is very important that we target children and pregnant women
about safe consumption habits and about light versus dark tuna, but also cover
all populations.
Fish
are well established as being a healthy source of protein. The FDA has an opportunity to give people
positive choices for fish consumption, not just what should not be eaten.
From
our work, I think really crucial is implementation, is how this is going to be
implemented. The old approach of
handouts and things like that or fish advisories on the web is not going to
work. We know this from our own work as
we try to implement some of our recommendations, you really have to target
specific populations.
We
know in the New York area, we have a lot of subsistence fishermen. We have recently learned that women in the
WIC program, women with infant children are subsidizing their food by fishing
in the East River, and this is a population that has been completely ignored.
Finally,
I just wanted to mention in the advisory, in the statement on what is mercury,
it notes mercury "occurs naturally in the environment and can also be
released into the air."
Mercury
is released into the air from industrial pollution. We don't need the word "can" there at all.
Also,
in the New York/New Jersey region, the major source of mercury is not
necessarily from the air to the harbor, it is through the wastewater treatment
facilities and generally from dentists, hospitals, and laboratories. So, that
statement isn't quite complete for the national picture.
That's
it. Thank you.
DR.
MILLER: Thank you.
Questions? Johanna.
DR.
DWYER: Just a quick one. On the values that you were talking about,
the samples that were analyzed, I was intrigued by Dr. Lund's suggestion
yesterday that there was a way to try to find out geographically where high
samples might come from, and wondered if you had done that, of if that group,
or anybody else had done that.
DR.
BOEHM: They have made note of where the
cans of tuna indicated they were from, the countries, but that doesn't
necessarily mean they
were caught near that country, because
the fish can be moved to areas where it is easy to process, so there is not, in
this report, they had no way to track where the fish were coming from.
DR.
ALLER: Just a quick question, I just
want to make sure I understood. For the
second half of your remarks, were you speaking for yourself or for the National
Academy?
DR.
BOEHM: New York Academy of Sciences.
DR.
ALLER: Thank you.
DR.
ACHOLONU: You mention that mercury
comes from dentists. Is that
significant enough to be mentioned in the advisory?
DR.
BOEHM: The mercury that you are seeing
in fish, there is no way to tell where it is coming from, and in different
places, it is going to have different sources. It is sort of a very separate
issue from what is being discussed here, I would say.
DR.
MILLER: The difference is, is the
amalgam. It is direct exposure. Since our concern is entirely on what
appears in the fish--
DR.
BOEHM: We are talking about mercury
that goes through a dental facility into the wastewater treatment facility and
gets into the New York/New Jersey harbor, not the direct human, in your mouth,
it is human contact. We are talking
about what ends up in the harbor.
DR.
MILLER: Right, and that is the source
of mercury that contaminate fish would probably be relatively small.
DR.
BOEHM: In fact, it is not because
wastewater treatment facilities are great methylators. They have all the right conditions for
methylating mercury, so it turns out to be a source of methylmercury to the
harbor.
DR.
MILLER: Thank you.
The
next speaker is Jane Houlihan, Environmental Working Group.
MS.
HOULIHAN: Good morning. I am Jane Houlihan, Vice President for
Research, Environmental Working Group.
We are a public health research organization based in Washington, D.C.
Just
a point of clarification, Dr. Miller, I requested and was told I was granted 15
minutes. Is that what you understand?
DR.
MILLER: That's right.
MS.
HOULIHAN: I just want to cover two
things briefly today. The first, is
this advice protective? We think it's
not and I will lay out some detailed calculations on why that is. I also want to talk about the adequacy of
some of the fish testing data that underlies the exposure and risk models and
that really forms a backbone of the consumer advisory.
For
many, many species, adequate testing has not been done, and it gives this
advisory a pretty weak scientific background for a lot of the popular fish that
are consumed in the U.S.
First
of all, I did just want to say congratulations to EPA and FDA. It's a big step forward to work together on
this advisory and get together on one page. I also wanted to thank FDA for
responding very rapidly in expediting a Freedom of Information Act request we
submitted for the new
testing data, so thank you for that.
As
you all know by now, there are three key parts to FDA's consumption
advice: Don't eat shark, swordfish,
king mackerel, or tilefish.
It
is safe to eat up to 12 ounces of seafood each week except for these.
Do
not eat the same type of seafood more than once a week.
Then,
the advisory tells the target population that following this advice is safe and
protective.
So,
I want to go into why it is that that advice is not safe and not protective to
follow in a lot of instances. The case
study I want to use is canned tuna, but I will also point out that a number of
fish that have even higher levels than canned albacore tuna later in the
presentation.
First
of all, this graph represents FDA's understanding of mercury levels in canned
tuna as it has evolved through time.
That second bar represents the average level of 0.17 ppm of mercury in
canned tuna as FDA understood it when the 2001
advisory was issued. At that point, the agency had very little
information to differentiate between kinds of tuna.
There
was a 1993 study done by FDA. That is
represented by the third bar. In that
study, 19 samples of albacore tuna were tested and were found to have significantly
higher levels of mercury than the bulk of the tuna samples FDA had in hand.
Well,
now this new testing program from 2003 really gives FDA a lot more ability to
differentiate between tuna types. So,
now we see the first and fourth bars on that graph represents what is known now
as the difference between light tuna and albacore tuna.
There
are substantial numbers of samples and probably represent a fairly good
estimate of what is really going on - 170 samples of albacore, even more
samples than that of light tuna.
So,
we see right off the bat, first of all, albacore tuna has twice the levels that
FDA believed were generally in tuna for the 2001 advisory. Albacore tuna has 3 times the levels
that are found in light tuna.
So,
out of this new understanding of mercury and out of the committee's
recommendations last year, that FDA really needs to tell women what is going on
with canned tuna, we get this advice.
Mercury levels in tuna vary.
Tuna steaks and canned albacore tuna generally contain higher levels of
mercury than canned light tuna, and we also get this sentence after this, you
can safely include tuna as part of your weekly fish consumption.
So,
a read of this advice and FDA's own statement that this implicitly means 4 to 6
ounces of tuna can be safely consumed each week gives us a safe scenario under
this advice of eating 6 ounces of canned albacore each week, and that is the
scenario I would like to look at in detail here.
We
find that the simple calculation outlined here that by eating 6 ounces of
canned albacore tuna each week, a woman of average size would exceed a safe
dose by about 30 percent. For instance,
a woman who weighs 140 pounds, a weekly
serving size of 6 ounces, which is 170
grams, translates into a daily serving size of 24 grams, so we are thinking
about average mercury exposures here and averaging them through time. Mercury concentration in canned albacore
tuna based on FDA's new testing program is 0.36 ppm.
So,
the amount of mercury this woman would ingest each day, of course, is her daily
serving size times the mercury concentration, and that equates to 8.6
micrograms of mercury each day.
The
body weight adjusted dose then, we just divide that number by her weight, 64
kilograms. Her long term steady state
dose from this consumption pattern is 0.13 micrograms of mercury per kilogram
of body weight per day.
We
compare that against EPA's reference dose of 0.1 and find that it is
substantially higher than a supposed safe level of exposure.
So,
the conclusion that we find from this is that women who follow FDA's advice
could face a significant risk of being exposed to mercury at levels above a
safe dose.
You
know one of the arguments that has been made is that women don't really eat
this much tuna, so we don't need to explicitly say in the advisory please don't
eat this much tuna. I just want to
point out some women from FDA's focus groups conducted in 2000 who said that
they do eat this much tuna.
I
haven't looked at the transcripts from the recent focus groups, but the 2000
focus groups, FDA tested their messages on approximately 100 consumers maybe,
and, of that, 5, I had pulled out 5 women from these groups. This woman ate tuna every day, 5 days a week
for lunch for 7 weeks.
This
woman ate more than a can and a half a week. She is referring to her long-term
consumption in this sentence.
Another
woman ate tuna every day for lunch because it was convenient. Another woman says she just bought a whole
bunch of it because it was on sale for 39 or 49 cents a can.
Even
another woman says she ate during the summer as part of being on the Adkins
diet, a can
of tuna, a hard-boiled egg. That was her lunch, and she was on this diet
in preparation for being pregnant.
Another
woman just sums it up as "It is real cheap," and that's why women eat
it, it is very convenient and cheap.
Now,
albacore canned tuna is more expensive than light, but it is still relative
inexpensive as a protein source for pregnant women.
We
went one step further and looked at the distribution of women in the population
and how much they weigh, and really a more detailed look at the risk faced by
women who would eat 6 ounces of canned albacore tuna a week.
We
conducted a Monte Carlo style model.
This is simply a model that creates virtual women by picking measured
body weights from CDC's NHANES population and pairing those with mercury
concentrations from FDA's most recent albacore sampling program conducted this
year.
So,
we used body weights, measured body weights for 1,767 women. We used mercury
concentrations in canned albacore tuna
from 170 samples, and we modeled a period of 40 weeks to simulate a typical
length of pregnancy. We are just
working with steady state concentrations here, we are not thinking about spikes
or shorter term exposures.
The
result of this model was that by eating a 6-ounce serving of albacore tuna
weekly, we found that 74 percent of all women would exceed a safe dose of
mercury for the duration of their pregnancy on average.
The
detailed calculation results are shown here.
The red line, the Y axis is, of course, the dose of mercury, the average
dose a woman is exposed to over pregnancy in this model. The X axis is the percent of women who
exceed that dose, and that red line represents the current reference dose from
the Environmental Protection Agency.
So,
you can see where the blue and red lines cross is really what we care about,
and we show that that percent of women exceed, 74 percent of women exceed that
dose.
This
point has been made in other ways, but I would just like to say the point of
this slide is to show that what FDA is doing in translating a risk model into
individual advice for consumers is inappropriate.
FDA's
simulations show that by chopping off, by forcing high-end seafood eaters to
eat less seafood, they can ramp down populationwide risks from about 8 percent
to 1 percent of over exceedences, but it does not, therefore, then translate
that it is safe to eat up to that amount for an individual. In fact, in FDA's
models, probably the women who tend to exceed the reference dose are those who
are eating 12 ounces of fish a week, and by telling an individual that is a
safe thing to do, you are actually advising them to do a fairly risky thing.
So,
the model has really been used in an inappropriate way in developing advice for
individual consumers.
I
want to use this slide to point out two things. The data here represent the new
data that
FDA collected this year in their
testing program. Tilefish in this
testing program showed an average concentration of 0.2 ppm. These fish are on the list of fish not to
eat.
Now,
these tests are substantially lower than tests that FDA based the initial
advisory on, but one of the interesting things in the new data is that 5 other
kinds of fish exceed the level that are in tilefish, I think gold-faced
tilefish that were tested. Bluefish,
sea trout, canned tuna, orange roughy, and grouper.
Now,
the question is tilefish levels are certainly not well understood. Levels were much higher in the earlier
sampling tests than they are shown here.
It is not even clear what tilefish are. I think people are very confused
about that. The data we were sent from
FDA calls the fish "golden tilefish," which I don't find in my
guidebooks or in FDA's regulatory market dictionary.
There
is something called gold-faced tilefish, it might be that, there is also a
Pacific
tilefish that is commonly referred to
as "ocean whitefish," so it is not at all clear what tilefish are,
and I think this is a concern because it is one of the four fish explicitly
mentioned in the advisory, and I don't think the agency even has a real
understanding of what it is.
It
is an example of sort of the weak scientific underpinnings of many points in
this advisory.
The
second thing I want to point out is that the new data show that there are fish
that have even higher levels of mercury than canned albacore tuna. We have shown that it is not safe to
regularly consume canned albacore tuna.
It would also not be safe to consume orange roughly or grouper if these
samples are representative of what is really going on in these species.
We
also find that tuna steaks and American lobster according to FDA's testing data
have similarly high levels.
This
is a quick comparison of data used by FDA to develop their 2001 seafood
consumption
advisory shown in the lighter bars, and
then the darker bars represent what their new data shows.
I
just want to point out that in a couple of key instances, the new data, even
though the sample sizes are very small, increase the agency's understanding of
what is going on with that fish dramatically.
In these cases, it seems that the mean levels for this fish group or sea
trout and bluefish are substantially higher than what the agency previously
believed.
This
is a concern for a couple of reasons.
The sample sizes FDA is working with are so small that even 20 samples
can significantly alter the agency's understanding of concentrations in fish. We don't see the kind of statistically valid
sample sizes we need really to have a solid scientific underpinning for an
important public health advisory like this.
This
is another instance where I am just showing you the sample sizes FDA is working
with in this risk model in the development of this public health advisory.
On
the lefthand side of this chart are the sample sizes FDA is working with for
the top 10 seafood in the U.S. - canned tuna, crabs, pollocks, salmon, catfish,
shrimp, cod, flatfish, tilapia,
and clams. This is ordered by sample size.
There
are only 3 kinds of fish in the top 10 seafood for which FDA has more than 100
samples. For 6 of these, FDA is working
with fewer than 30 samples.
I
just compare that briefly to an assessment FDA recently did on children's
exposure to organophosphate pesticides.
This is just a tiny fraction of their sampling program. I pulled out some fruits and vegetables they
test as part of the underpinning to their assessment of just one
organophosphate pesticide of the many analyzed dimethoates. They sampled a
minimum of hundreds of samples for each of the fruits and vegetables that were
included in the assessment.
They
sampled over 2,000 carrots, they sampled almost 2,500 apples, over 1,000
bananas to provide them the kind of scientific underpinning
that they needed for this public health
advisory, and the risks are of similar magnitude to what we are talking about
here, if not greater magnitude here than EPA's analysis.
So,
I just want to point out briefly, just pull out 3 of the fish in the top 10 to
show you really the kinds of complexities we are working with and the kinds of
sample sizes that are really needed to understand what is going on here.
FDA
has tested 25 samples of shrimp. Shrimp
is the number one seafood in the U.S.
The National Marine Fisheries Service data shows it is caught
commercially in 20 states, it is imported from 21 countries, it is farmed, it
is caught in the wild.
We
eat such a diverse source of shrimp and we only have 25 samples, and for the
top seafood in the U.S., this does not seem like a solid scientific basis for
moving forward with an advisory that includes advice on shrimp.
FDA
has tested 6 clams. Claims is the No. 6
seafood in the U.S. The National Marine
Fisheries Service says it's landed in 9
states, we import from 30 countries.
Six samples of clams is not enough to move forward with a public health
advisory on clams.
FDA
has tested 8 tilapia, the No. 9 seafood in the U.S. It is landed commercially in 2 states, we import from 27
countries. Clearly another case where
the sample size is insufficient for FDA to understand what the mercury
distribution might be in that particular fish, and clearly, the sample size is
not sufficient to move forward on that fish with a public health advisory that
includes advice for women to consume that fish.
DR.
MILLER: Would you summarize, please.
MS.
HOULIHAN: Yes. I am on the last slide.
Our
recommendations are, first of all, obviously, FDA should test fish. They need to adequately characterize the
distribution of mercury levels in the U.S. seafood supply. They can't get there by testing 20 fish a
year for a fraction of the species we eat.
This
has got to be a big comprehensive sampling program that has some statistical
backing, and I hope the committee can recommend that FDA do this because I
think it would help them shake loose some funding to get that done, which would
require substantial funding.
FDA
should issue an advisory that tells women what fish are safe to eat in
quantities that meet omega-3 requirements.
Two of three peer reviewers told FDA specifically please consider
omega-3's when you are developing this advisory. We think it is really important, women need to be able to consume
fish safely to meet their omega-3 requirements. It is very important for proper fetal brain development.
One
of the key things FDA can do in that department is provide consumers with a
list of safe fish. FDA should also add canned albacore tuna, as well as the
other species I mentioned with high levels, to the list of fish women of
childbearing age and children should not eat.
Any
questions?
DR.
MILLER: Yes.
DR.
ACHOLONU: A few speakers have made the
observation that some of the common names varied depending on where you are.
Do
you think it would be advisable for the FDA to include the scientific name of
the fish, put that in parentheses in the advisory to be distributed to the
public?
MS.
HOULIHAN: I think that is absolutely
critical, and I think FDA has got to figure out what is going on in the various
states, so that people get the right advice in the right state.
I
mean you brought up the example of cod, and I will pull that out, because cod,
71 percent of our cod we eat is domestically caught, Pacific cod from Alaska,
12 percent is imported Atlantic cod, 17 percent is imported other cod. FDA has
20 samples of cod, most of it is domestic.
They have 2 samples just called "cod," one sample of black cod
that I actually think is from a completely different family of fish.
So,
it is so complex and will vary so
much, and it is such important advice
to get out to people that it is really going to require that FDA and EPA figure
this out.
DR.
MILLER: Yes.
DR.
NELSON: Considering your statement that
you want the advisory to be science based, and the data you provided about the
analysis for
tilapia and shrimp, are you suggesting
that FDA
consider those guilty until proven
innocent, or disregard those species, or what?
MS.
HOULIHAN: I think because of the import
to public health, if I were in charge of FDA, I think what I would do is move
forward with advice on fish for which they have statistically significant
numbers of samples, and that includes canned tuna. So, I feel like they are in a good position now to include
albacore canned tuna on the list.
I
would also advocate for providing a list based on the agency's current
understanding of what low mercury fish are, so women know what is safe to eat,
and then, at the same time, move forward very
aggressively on testing fish in
adequate levels, so they really get a much more in-depth understanding of the
distribution.
DR.
NELSON: I also wanted to comment on the
emphasis on a safe level, or, in quotes, on a "safe" level in
reference to the RfD, and wanting sound science and something definitive.
I
don't believe the RfD is quite that solid in that sense, not the calculation,
but the concept of the safety, and I am not convinced that somebody consuming
0.13 as opposed to 0.1 is a significant increase or decrease in safety, if you
will.
MS.
HOULIHAN: Right.
DR.
NELSON: I think the RfD is based on
consumption over a lifetime, and I think that is why, in earlier drafts of the
advisory, we saw a statement like if occasionally you consume more, it is not
the end of the world, but clearly, the advice needs to be there to moderate the
consumption.
MS.
HOULIHAN: And I think it is also
important to remember that the
reference dose is consistent with NAS recommended benchmark dose which is
derived from fetal cord blood levels, and the NAS said that those are best
thought as corresponding to probably a trimester of pregnancy.
So,
in that instance, FDA's assessment is not conservative, but they are
considering steady state dose over an entire pregnancy, they are not
considering excursions above the RfD for a trimester or shorter periods during
pregnancy.
DR.
DWYER: It seems to me two things are
becoming clear from what you have said.
One is just the notion of modeling, I don't think you are disagreeing
with. You are just saying you think you
have a better model, right?
MS.
HOULIHAN: I think that the data that
underlies this model is extraordinarily weak.
DR.
DWYER: It seems to me one of the pieces
of data that is weak, that you didn't mention as much, that I thought I heard
Dr. Acheson say that they were trying to remedy is the issue of exposures.
In
other words, and it is complicated by what Dr. Alex just said about the names,
in other words, for things that are not very commonly eaten, not perhaps
tunafish, but some of these other fish, you really have to do better than what
we are doing right now in national survey data.
It
seems to me it is very important in our recommendations for the future that we
include better estimates of recalls than we get right now. I think there is some work being done now on
a propensity sort of questionnaire to add to the data that we could get from
NHANES, and I hope that is done.
The
second point is exposure depends on knowing what people are eating, and the
other thing it depends on, as you pointed out, were food composition values,
and in this case, this contaminant. I
think it is very important, as you do I guess, to get as many representative
data as we can on the mercury levels in these various kinds of seafood.
Again,
I wonder if the only way to get
them is having FDA go out and do a huge
survey. It probably doesn't come as
news to you, but there are many values for many nutrients that are not much
better than the values we are talking about here. We don't have a lot of food composition data even sometimes on
essential nutrients.
So,
again, I go back. Are there any other
sources other than going out and doing food surveys where we could get more
data, perhaps industry, perhaps states have data, that are collected in a
uniform fashion using appropriate standards for judging how much mercury there
is, just to get on with this instead of going into the fourth millennium still
arguing.
DR.
MILLER: Dr. Russell.
DR.
RUSSELL: I wonder, are you suggesting
that FDA and EPA do a continual survey of fish, kind of ongoing, with the idea
that maybe levels are rising in certain fish species?
MS.
HOULIHAN: It may be that levels are
changing in certain species. There
aren't the data to say that definitively.
But it makes a lot of
sense particularly for fish that live
near the coast where land-based pollution may be much more of an issue.
What
I would like to see is a big comprehensive testing program, one big bang
program to try to get a really good grasp of this problem, get a great consumer
advisory developed out of that, and then a smaller program of ongoing testing
that would try to get at some of the issues of trend or levels going up with
time.
DR.
MILLER: But are you saying that FDA and
EPA should delay issuing their advisory?
MS.
HOULIHAN: I don't think we lose much by
not issuing this current draft advisory because it doesn't really represent any
more substantive information for consumers than the previous advisory.
What
I do advocate for the agency going forward with at this point is getting
information to people much more specifically on canned tuna, an explicit
warning, and explicitly telling pregnant women to not eat canned albacore tuna,
and I would
also just advocate that FDA move
forward with getting a list of fish to women that are believed to be low in
mercury at this point.
DR.
RUSSELL: Just one other thing I have
been thinking about. If you come out
with a list of fish that you say are safe based on mercury, are you concerned
that down the road, that some of those fish on the safe list will be
contaminated with PCBs or something else, and then the message has become just so
very confusing about what you are telling people to do?
MS.
HOULIHAN: Right, and if not more, it's
a three-pronged problem because omega-3's are so critical, it is our most
important source of omega-3's, and mercury and PCBs are both big pollution
issues in fish.
So,
for instance, if FDA moved forward with recommending that people eat farm
salmon, that is probably not safe from the perspective of PCBs. So, I have advocated for a long time that
the agency take a more holistic look at seafood.
DR.
MILLER: We are going to move on. We
have several speakers still and it is
only fair they have their chance.
Thank
you.
The
next speaker is Dr. Rick Jarman from the National Food Processors Association.
MS.
APPLEBAUM: I am also from the National
Food Processors Association, but I am Rona Applebaum instead of Rick Jarman.
Good
morning. I do work for the National
Food Processors Association. I work as
their Executive Vice President and Chief Science Officer. NFPA is the principal scientific and
technical trade association for the food industry. We represent over 400 processing and supplier companies.
Our
focus is public policy and science issues involving food safety, food security,
nutrition, technical and regulatory matters, and consumer affairs, and NFPA has
no financial relationships with either of the sponsors.
We
very much appreciate this opportunity to share our comments on FDA's and EPA's
activities
regarding the revisions to the agency's
consumer advisory on methylmercury and fish consumption. We are strong advocates for the use of sound
science as the basis for any and all dietary advice given to consumers.
We
believe the FDA is to be commended for addressing the recommendations given to
them by the Food Advisory Committee and moving forward in a timely manner to
develop and test the revised consumer advisory.
My
comments this afternoon will focus on the consumer advisory, consumer testing,
as well as the need for more research.
Advice to consumers on fish consumption is very complex. Advice to consumers in general is very
complex. It is critical that any action
taken in regards to consumer advisories assess the potential adverse impacts
that may result due to the reaction on the part of the public to such advice.
The
potential impact of advisories, including those designed to improve public
health, must consider the full range of implications that
may result to ensure the initial good
intent of the advisory follows through to positive outcomes. More on this in a few moments.
Thus
far, we believe FDA is meeting the challenges of integrating information from a
variety of sources on the numerous factors that must be considered in providing
sound actionable advice to the public on safely consuming fish which has
repeatedly been recognized as contributing to a healthful diet.
It
is clear that FDA is considering all of the key issues including quantities
consumed and the benefits of fish consumption in order to provide consumers
with the facts and the necessary advice on methylmercury and fish consumption.
NFPA
has actively followed FDA's process of reviewing the consumer advisory. We believe that gaining insight directly
from consumers is essential.
For
any consumer advisory to be effective, they must be both understood and
correctly interpreted by consumers.
Messages are important,
but it is critical that their ultimate
result be a positive behavioral change.
To
this end, message testing is an absolute necessity, and such testing
appropriately has been an integral part of FDA's activities in reviewing its
consumer advisory.
Throughout
the process of reviewing and revising this consumer advisory, FDA has
acknowledged the difficulty of wording an advisory, so that it provides
appropriate guidance to the populations at risk to help these populations
decrease their methylmercury exposure while not discouraging consumers, or
worse yet, steering consumers away from diets containing fish and other
seafood.
Let's
not forget the majority of food purchases are done by female heads of
households. What they choose to bring
into their homes is not only their dietary regimen, but also the dietary
regimen of their family.
To
this end, based on our observations from the FDA focus group sessions, we
strongly
believe that further consumer testing
is necessary to ensure that any revisions to this consumer advisory are
effective in better informing consumers.
What
we must avoid at all costs is the unintended effect--and it has been discussed
today--of the advisory being read,
understood, and interpreted as a warning against consuming all fish. Warnings, by nature, and its consumer
research supports, can be translated into complete avoidance behaviors
especially if alternatives exist.
The
concern here is that alternatives that might be selected--and I am not
referring to fish alternatives, I am referring to non-fish alternatives--will
not be identical substitutes necessarily.
In
this instance, the concern that bears mentioning is the avoidance again of all
fish with substitutes that do not provide the equivalent nutritional benefits
of fish.
This
is a major concern and is
contradictory to the advice given by
many public health professionals, public health societies, and public health
agencies and departments including FDA, HHS, and USDA.
The
message fish can and should be part of a healthful diet is sound. Messages that may be interpreted as no fish
are not a benefit to public health.
In
addition to the necessary research that must be done to ensure advisories
inform and not result in negative behaviors, other research will be helpful, as
well, in providing FDA with further information on fish and methylmercury
exposure.
We
are now pursuing one such research direction. While it is true that
methylmercury exposure poses health risks, it is also true that fish
consumption confers real health benefits.
These benefits would be lost if consumption of all fish--and I repeat
all fish--were reduced in an attempt to reduce methylmercury exposure where
action is being based on incomplete information.
Clearly,
a comparison of the methylmercury
risks to the risks of reduced fish
consumption is necessary to ensure that any policy, including the way in which
advisories are worded, helps rather than harms public health.
Through
the NFPA Research Foundation, a project is now underway to review the data
published on the impact to health of dietary exposure to methylmercury, and
evaluate and compare the risks of benefits of efforts aimed at influencing the
consumption of fish.
Some
might call this a risk-risk evaluation, others a risk tradeoff, but it is
currently being undertaken, and you will hear more about this research from the
project director, Dr. Joshua Cohen, of the Harvard Center for Risk Analysis.
In
summary, while FDA's revision of its consumer advisory is still a work in
progress, the agency is to be commended for its efforts to carry out the
recommendations of the Food Advisory Committee.
We
believe consumer testing is necessary,
will be helpful to ensure that the
consumer advisory meets the goal of better informing the
at-risk population on ways to decrease
their methylmercury exposure while not resulting in behaviors that may direct
them away from all fish and other seafood.
Finally,
we must remember that consumer advisories and messages concerning public health
are only tools for public health education, and are not complete solutions in
and of themselves, nor should they be.
NRPA
thanks you, FDA, EPA, and the Advisory Committee for the opportunity to provide
these comments.
DR.
MILLER: Thank you.
Just
a quick question. Dr. Dwyer has several
times raised this possibility of expanding the database from which these
advisories are made with data from the industry.
Would
NFPA be willing to cooperate in developing that data?
MS.
APPLEBAUM: NFPA has been involved in
developing a number of data on a number
of issues. There was a recent
publication on the levels of methylmercury in fish recently reported. I apologize, Dr. Sanford, for not knowing
exactly the publication, but when we are asked to provide such information, we
have stepped forward.
DR.
DWYER: Would that be publicly
available, going into a database that was--or is it just your own publication?
MS.
APPLEBAUM: The publication, it's in the
peer-reviewed literature, so there is information out there.
As
with anything, Dr. Dwyer, we would talk with our companies in terms of
developing ideas, but if the data is there, we would want to provide it to the
stakeholders.
DR.
DWYER: I have done a lot of giving
advice to people about eating things and not eating things, and very often they
don't do either of those things.
Can
you think of any government advisory that has ever substantially decreased
consumption,
and if so, what are those advisories?
MS.
APPLEBAUM: Well, I think in terms of
messages that were given out earlier, the last decade and in the late '80s,
relating to cholesterol and fat, consumers heeded it.
What
was missing in that point, and, you know, when you look at the National
Cholesterol Education Program and the progress that was made there, that was
one that I think that had benefit, but when you look in terms of the focus
exclusively on fat messages and the impact in terms of overweight and obesity,
in terms of the lost message on calories, we have to be very careful as it
relates--and you know this better than I do--as relates to giving consumer
messages, so that easy messages in terms of the easy take home, is not what
drives the issue of bigger impact.
That
is why, at the end, in terms of my final comments, advisories and messages are
only one part, one tool in terms of a public health education program, and not
solutions in and of themselves.
DR.
MILLER: Thank you.
The
next speaker is Dr. Diana Zuckerman from the National Center for Policy
Research.
DR.
ZUCKERMAN: I am Dr. Diana Zuckerman,
President of the National Center for Policy Research for Women and Families,
and our Center is a think tank that works to improve the health of women,
children, and families, and we don't take contributions from anyone that makes
any product that we might at some time say something nice about or something
not so nice about.
Like
you, our goal is to ensure that scientific information is made understandable
and available in ways that safeguard everyone's health and make sure that
consumers can make educated choices.
I
have been attending FDA meetings on this topic for several years, and I am glad
to see real progress, and I really thank you because I think a lot of that
progress is really due to this Advisory Committee.
However,
the proposed FDA/EPA advisory is
confusing, as we have heard people say,
and the FDA's own scientists have found that the 12 ounce limit is too high to
reduce mercury levels in women.
As
an epidemiologist, I feel very strongly that data are essential in answering
the questions we need to answer and providing information. According to the information provided to
this Advisory Committee yesterday by Dr. Carrington, the proposed limit of 12
ounces of fish per week would not significantly decrease methylmercury levels in
women.
According
to the FDA's analysis, 12 ounces of tuna, particularly albacore tuna, and some
other fish in the moderate category is just too high. So, the question is why is it in this draft advisory.
Your
task is incredibly difficult and very important, and we are counting on
you. You need to make sure that adults
are warned, in way that they will understand and in ways that they will
remember, so that children and pregnant
and
nursing women are not harmed. So far the FDA has not succeeded in getting
the message out to the people who really need it.
Our
Center specializes in explaining research-based information to the general
public, and we have been working very closely with the National Cancer
Institute on some patient booklets, and I think it is informative, the
experience we have had with them.
In
preparing a patient booklet, they hired a specialist to translate all this
research-based information that was going to patients, to translate into simple
words and simple sentences that were suitable for women at the middle school
reading level.
That
seems very dramatic to me and drastic, and I have to admit I didn't like it at
all because you lose so much information when you are trying to get down to
that middle school level, but apparently that is what NIH does for their
patient booklet, they aim for a middle school level because there are, in fact,
a lot of people in this
country who, although they may be high
school graduates, cannot read at a higher level than that.
They
call this plain language. The words
have to be short, so they use words like mercury instead of methylmercury, they
might even use words like often instead of frequent. But it isn't just the words, it is really just dumbing-down the
vocabulary.
It
is also having ideas that are simple and straightforward and clear. So, using that as a guideline, a
methylmercury advisory needs to say at least two things. Some fish, actually many fish are very good
for you, and some fish are potentially dangerous if you are pregnant or a child
or a woman who is nursing.
Now,
we think that people can understand these two messages if you explain which
fish are safe, which fish are not safe, and the ones in between. But we think what is wrong with the advisory
as it reads now, is that it tries to do something a little different.
It
tries to say fish are good, and these
are the fish that are bad, and that is
not logical. That doesn't follow
logically and it feels like spin control.
It doesn't feel like advice for consumers, it feels like some kind of
politically correct effort to say fish are good, but just these fish are bad,
when, in fact, really what you want to say is these are the fish that are good,
and these are the fish that are bad, and you actually might have to say bad
even though we don't like to use terms like that.
With
all due respect, I am just shocked by the way this process works, because I
know from my experience with the National Cancer Institute that for $500 or
$1,000, you hire one of these specialists, they write it, they rewrite
something, make sure that the language is clear, the ideas are clear, but that
it is still research based, and it takes them a few hours to do this. It is not a huge task.
I
also agree that a simpler way to do this is to have separate advisories, one
for pregnant women, nursing women, a different one for children,
and a different one for other adults,
and perhaps one for people with heart problems. That's new information for me, I didn't know about that.
It
feels to us that the underlying problem is the FDA's reluctance--and perhaps
EPA's reluctance--to say that some popular fish are relatively high in mercury.
They
just don't want to say it. But we have
to get over that because if we don't clearly say which fish are dangerous and
which fish are safe, people really will come away with the wrong message, and
that will be more dangerous for everyone.
DR.
MILLER: Could you summarize, please.
DR.
ZUCKERMAN: Yes, I can. Thank you.
I
just want to say that I know that some experts will be pointing out that we
don't know exactly how dangerous methylmercury is for pregnant women and young
children, we don't have all the data we need.
It
might not be as dangerous as some people think or as the Institute of Medicine
has
estimated, but none of us would want to
include our children or our grandchildren in that kind of study to expose them.
In
our experience, the Institute of Medicine, which is very concerned about this,
is very cautious, so we take their concerns very seriously and we hope that you
will in trying to figure out how to present this information quickly.
I
think that is the other thing, not to delay this too much, not to use the
proposed advisory as it is written, but have something that is simpler to
understand, but that gets some of that information out as soon as possible.
Are
there any questions?
DR.
MILLER: Comments or questions? Yes.
DR.
ACHOLONU: You are advocating that if
the EPA puts out different kinds of advisories, wouldn't this open a can of
worms, will this not cause confusion, and wouldn't several groups be clamoring
and asking for their own?
DR.
ZUCKERMAN: Well, I think that an
advisory, if it is very complicated, even saying
women who are pregnant, women who might
become pregnant, and women who are nursing, that alone is somewhat complicated,
and when you add children to that, and you are not exactly sure what the levels
are for children, I think it is very difficult.
So,
I think it is fine to have short summaries that are targeted for different
groups, and then maybe have the one part that is the same for everybody, which
explains a little bit about what methylmercury is or what mercury is, and why
is it potentially dangerous.
So,
I don't think so. I do think you might
even need a different kind of advisory for physicians. They are not going to want the 8th grade
version of this. I think it would be
fine to have a more sophisticated version, they would want a short one, but
maybe not 8th grade level, for physicians than the one for the general public
because the needs are somewhat different.
DR.
ACHOLONU: So, about how many do you
think we should have, two, three, or four?
DR.
ZUCKERMAN: I think it would be very
helpful to have simple ones for
pregnant women, women who might become pregnant, one for kids, and one for
other adults who are not of reproductive age at the simple level, and then
perhaps one that combines all of those things for a more sophisticated audience,
such as physicians.
DR.
MILLER: Thank you.
The
next speaker is Dr. Joshua Cohen of the Harvard Center for Risk Analysis.
DR.
COHEN: My name is Joshua Cohen. I am the senior research associate at the
Harvard Center for Risk Analysis at the Harvard School of Public Health. I am here today to discuss the work our
Center is conducting to inform policies addressing the presence of
methylmercury in commercially caught fish.
I appreciate the opportunity to address the FDA Food Advisory Committee
today.
I
will be describing the work related to a grant funded by the National Food
Processors Association Research Foundation.
That grant has also funded by travel expenses today, and I do not have
any connection to the sponsors of this
meeting.
The
issue of methylmercury in commercially caught fish is particularly difficult to
address because fish consumption has health effects that cut two ways. Methylmercury is known to be a neurotoxin to
which unborn children may be especially vulnerable. Methylmercury may also affect adults with recent studies
suggesting that it may increase the risk of coronary heart disease.
On
the other hand, fish are a rich source of nutrients, in particular omega-3
fatty acids, that are thought to aid neurodevelopment during the perinatal
period. These nutrients may also reduce the risk of mortality associated with
coronary heart disease in adults, so it cuts two ways.
In
a project funded by the NFPA Research Foundation, the Harvard Center for Risk
Analysis is currently addressing this policy issue by quantitatively comparing
the health risks and benefits of fish consumption. The idea is that policies
affecting fish consumption in either direction also influence these risks and
benefits.
The
only way to know whether a change in fish consumption is beneficial on net is
to quantify the risks and benefits and then to compare them. The Center for Risk Analysis is currently
drafting several manuscripts that quantify the relationship between fish
consumption and these various health effects.
A future paper will aggregate these results and quantify the net health
benefits or the net health loss of hypothetical changes in fish consumption.
The
risk tradeoff analysis we are conducting in the context of methylmercury in
fish differs significantly from the evaluation of methylmercury conducted by
various regulatory agencies. For
example, EPA's reference dose attempts to identify a level below which exposure
to methylmercury is of limited concern.
While
this benchmark can be useful for the purpose of identifying exposures that are
worthy of further consideration, it does not help decisionmakers to determine
how badly public health will be affected if exposures exceed this limit,
nor does it help us to understand the
public health costs that may be associated with even those exposures below this
limit.
Importantly,
the reference dose does not take into account the nutritional benefits of fish
consumption. To complicate matters, it
is not clear how the advisory affects fish consumption patterns as has been
discussed here extensively today.
The
key point is this. The focus on determining
the impact of an advisory on the proportion of women above the reference dose
is inadequate from a public health perspective. To know if an advisory is a good idea, we need to understand how
it will influence fish consumption for the whole population, not just the
target population, how the change in consumption will influence both exposure
to methylmercury and the intake of nutrients, and how these changes will
influence the probability of different health effects.
Because
such an analysis has not been
conducted, we do not know what the net
public health impacts of advisories are.
We hope that the project we are currently involved in will help to shed
light on this issue.
DR.
MILLER: Thank you.
Comments
or questions?
DR.
LUND: Dr. Cohen, I didn't hear the date
when you expect some of these results to be coming out.
DR.
COHEN: Well, the manuscripts are
virtually complete. We are going to be
submitting them for peer-reviewed journals, and, of course, you know that is an
uncertain proposition in terms of the timing, but we would hope that a year
from now, these papers will be in the peer-reviewed literature.
DR.
DURST: You are talking about developing
an advisory for the entire population, which, since this one which is narrower,
is already fairly complicated, would you agree with the previous speaker in
that a number of different advisories would be more beneficial in terms of
directing it towards the various
populations?
DR.
COHEN: Actually, perhaps I wasn't
clear. I am not advising or I am not
suggesting that an advisory for the whole population is a good or a bad
thing. What I am saying is that
whatever advisory is considered, be it the one that EPA and FDA described this
morning or anything else, what is important is to figure out how that is going
to change people's fish consumption patterns and then trace that through to
changes in the incidence of various health effects.
What
I was saying in relation to the population at large is that even if you target
an advisory to pregnant women, it may influence consumption among other members
of the population, and that needs to be taken into account.
DR.
HEIMBURGER: You have put us in a very
difficult position by telling us that you have data that you are submitting for
publication and an advisory could come out very soon, well before your--I don't
know, I am new to the process, maybe it won't come out soon--well before your
data are
published.
Can
you give us any indications of how your data might specifically impact the
advisability of any of the recommendations made in the advisory?
DR.
COHEN: Unfortunately, as you know, when
you go into the peer-review process, you know, the peer reviewers can cause you
to change things, so I think it would be premature for me to say, well, the
answer is X and then next year it turns out to be X plus or minus something,
and that is just confusing for anybody.
DR.
HEIMBURGER: Well, then, what you have
done is you have put us into--I mean data are always be in flux, there will
always be new data come out, and we really don't know how to respond.
DR.
COHEN: Okay. Well, I mean I would say what we are providing isn't new data,
it's an aggregation of the existing data.
What I am really trying to stress here is that before the government
goes ahead and puts out an advisory that is going to affect people's behavior,
they need to
understand how it is going to influence
that behavior, and if the government doesn't understand that, then, maybe it is
not a good idea to do it.
Otherwise,
I mean you don't know, you just don't know if this is going to be net good or
net bad. It might be net good, but you
don't know.
DR.
MILLER: The problem really is that if
you have a situation that has a significant public health outcome, the longer
you wait, the greater the risk is.
The
other point is that, and I still think it is something for this committee to
suggest even though it is self-evident, that this process that FDA and EPA are
going through ought to be an ongoing one and that changes in the advisory
should be made on the basis of relatively short periods of time as new data
becomes available and a new analysis is going to be available.
I
mean what struck me about this business going through the last two meetings is
how things seem to be changing every month.
There are new data, there are new approaches to the data, there
are new ways of analyzing the data, and
if we waited until the questions were all answered, there would be no advisory
at all.
I
understand the point you are trying to make and I agree with it, but the
question is a matter of time, and you are not prepared to share that.
DR.
COHEN: I mean we don't even have the
aggregation yet, so even if I wanted to, I couldn't share it and besides it is
not even in the
peer-reviewed literature.
DR.
MILLER: I don't mean that
critically. I am just saying that is
the reality of life for the people who are going to write this thing. We are not going to write this thing. This committee is going to make
recommendations to the people who will write this thing, whatever point they
take.
But
I would suggest that the committee consider that kind of recommendation to be
made to the agency, otherwise, if we are trying to pick things out, we are
never going to get any kind of recommendation.
DR.
COHEN: Yes, I am I recognize obviously,
you know, things have to be done in a timely manner and while you wait, people
are living and being exposed to things.
I guess I would urge you to advise FDA and EPA to at least address the
broader public health question, that is, what is the net overall effect of
this, not just focus on the mercury or on the nutrients. I mean you have to look at things
holistically, otherwise, you don't know if you are doing net good or net bad.
DR.
MILLER: Good. Norman.
DR.
KRINSKY: Could you just tell me how you
were able to evaluate how the advisory would alter fish consumption. Do you use focus groups of some equation?
DR.
COHEN: No. What we have done, the focus of our work is essentially looking
at dose response, to say if omega-3 fatty acid consumption intake increases by
thus and so, what benefits does that confer, likewise, for methylmercury on the
adverse health effects.
It
is very difficult. We have not focused
our research on looking at how fish
consumption for a particular advisory would affect things. We will consider some hypothetical changes
to illustrate what the net impact will be, but, of course, without knowing the
exact wording and conducting the type of research which FDA and EPA have
described, but I think they need to do more and do more extensive research to
figure out how the population, fish consumption will be affected, you know,
that the overall picture is not going to be complete.
So,
our component is going to be the
dose-response relationships for the
omega-3 fatty acids and for the methylmercury, which is to think from an
RfD. An RfD, reference dose, I am
sorry, does not tell you what is going to happen below or above, as I think
someone even mentioned on the panel this morning, the difference between 0.13
micrograms per kilogram per day, and 0.1, you know, the RfD says 0.13 is bad,
0.09 is okay. Well, in reality, that is
not true. There is a gradation, and
that is what we are going to try to explain
quantitatively, so that the net
benefits of changes in fish consumption or the net adverse effects can be
characterized.
DR.
MILLER: Thank you very much.
Is
this an important question, Johanna?
DR.
DWYER: Of course, Dr. Miller, all of my
questions are important.
[Laughter.]
DR.
DWYER: Thank you for clarifying what
you are up to. What I was wondering,
since the focus of the analysis is primarily on omega-3 fatty acids, two
questions.
One
is accounting for other sources in the diet than fish, and, secondly, it is my
understanding an evidence report has been in process, I think it is about a
year, through NIH. I assume that you
would be taking that into account in your analysis, or have you already
submitted the manuscripts? I gather it
will be out in two or three months.
DR.
COHEN: First of all, we have not already
submitted the manuscripts. We focused
on
the omega-3 fatty acids because that
seems to be the key issue in terms of nutritional benefits.
Optimally,
one would want to look at not just the omega-3 fatty acids, but on the other
nutritional benefits. But, you know, in
order to get this done, this we think is a very useful first cut, and even so,
it is taking time.
Now,
the NIH report, I am not sure I am familiar with that.
DR.
DWYER: I think it is through the
evidence-based practice centers, and I know it has been in press for about a
year.
DR.
COHEN: On omega-3 fatty acids?
DR.
DWYER: That is correct.
DR.
COHEN: I am trying to remember. I think we have that report, but I can't--
DR.
DWYER: If you do, that is surprising
because I don't believe the NIH has it yet.
DR.
COHEN: Well, I don't know. Again, I can't remember exactly which
government reports we have looked at,
so I guess I just don't know the answer to that question without knowing
exactly
which report you are talking about.
DR.
MILLER: I think we had better move
on. Thank you.
The
next is Mr. John Stiker from the Bumble Bee Seafoods and U.S. Tuna Foundation.
MR.
STIKER: Thanks for having me. My name is John Stiker. I am a Senior Vice President at Bumble Bee
Seafoods, so in the spirit of disclosure, I work for tuna company.
I
had promised Dr. Acheson yesterday that I would include a little bit of kind of
a Tuna 101, as I heard some of the questions about differences between white
meat and light meat, where tuna are harvested, but I think I have only got
about eight minutes, and I am going to be talking fast as it is, so I have
included that as an appendix in the presentation that has been handed out.
DR.
MILLER: Five minutes.
MR.
STIKER: I thought I had eight, so I
will go really fast. So, if there are
questions on that afterwards, I would be happy to field them.
I
have titled this presentation The Curve
Has Changed, and the curve that I am
referring to is the curve that we tend to ground ourselves in, which is the NHANES
curve, which was plotted out in the July 2002 Food Advisory Committee.
This
one provided critical data on actual blood levels among American women and here
is where the 7 to 8 percent of women over the EPA RfD curve came in, which led
to that often cited 300,000 babies at risk claim.
Worth
remembering, though, as we think about it, is that the average safety and
uncertainty factor for that population that was above the EPA reference dose
was, on average, still 8-fold, and none even approached the Faroes NOAEL.
So,
from the tuna industry perspective, we do consider the reports of the
methylmercury health crisis to be overblown.
We do, however, support the concept of minimizing methylmercury
exposure, but we believe it should be done responsibly, balancing the need to
maintain or even increase overall seafood consumption given its health
benefits.
So,
the question that we ask ourselves as we are now four years post-NHANES and
considering revising the advisory is do we have any new data which suggests
that food consumption or methylmercury intake is up since NHANES or even that
it is static, or do we have new data which suggests that seafood consumption
and methylmercury intake is down since the NHANES and, since the advisory, is
the curve improving.
So,
let's take a look quickly at what the data tells us about the impact of the
advisory. First, the study published by
Dr. Emily Oken. Hopefully, you have all
seen it in Obstetrics and Gynecology, demonstrated a dramatic dropoff in fish
consumption among pregnant women in Massachusetts post-advisory.
For
canned tuna, the percent change in consumption was down 28 percent--ouch-- for
overall seafood, 17 percent. I laugh
about it, but I would tell you that I am not sure that is even the impact that
you want to have with that advisory.
Yet,
despite the fact that many women may
not read it, you get the headlines like
this morning's Washington Post, "Federal warning on tuna
planned." I can tell you exactly
what impact that is going to have on consumption.
So,
it is being heard and felt throughout the seafood industry. In fact, here is the data released by NOAA
and NMFS on seafood consumption, and you can see what happened to tuna. We used to refer to tuna as the most
popularly consumed seafood in America.
Post-advisory, it's not anymore.
In fact, in 2001, post-advisory, we experienced a 17 percent decline in
consumption.
We
had a very modest recovery in 2002, but that is a 14 percent two-year drop in
consumption post-advisory. Contrast
that versus the years that the NHANES data was collected. So, in the NHANES years, we were seeing
about 3 1/2 pounds of tuna consumption per year. That has dropped notably since the advisory.
To
put that in perspective from a relative health point, however, you can look at
ounces per week as we think about the 12 ounces per week
number. From our standpoint, we have taken consumers who eat very little
canned tuna to begin with, about 1.1 ounces per week, and encouraged them to
eat even less.
The
average per capita consumption, as you see there, is about 1 ounce per
week. We split in our industry about
two-thirds or sometimes 70 percent light meat, one-third or 30 percent white
meat, which suggests average albacore consumption of consumers of 0.3 ounces
per week. Even at the 95th percentile, which starts to get pretty far up there,
canned tuna consumption is less than 5 ounces per week or less than 2 ounces
per week of albacore.
This
is despite the fact that tuna and, in particular, albacore tuna is the second
highest source of omega-3 fatty acids of all common seafoods and certainly the
most affordable.
As
you look through that list and think about a trip to your local grocery store,
you are going to pay 3.99 to 4.99 a pound for almost every seafood that is up
there. Chunk light tuna
typically sells, as you will see in the
back of your packet, for about 69 cents a can, albacore sells for about 99
cents a can. It is a terrific
economical value for the U.S. consumer.
So,
while the perceived risk may be abated, as Dr. Cohen seemed to allude, the
tradeoff by reducing omega-3 consumption from canned tuna is very real,
something is going on, and we know that the benefits to omega-3's to both
mother and child are well documented from fetal brain and retinal development
to achieving full-term delivery, to other maternal benefits.
At
Bumble Bee, we wondered where is that tuna volume going. Tuna is unique among all fish in that it is
the only fish commonly used in a sandwich.
In fact, you can see there that over half of our consumption is in a
tuna sandwich. So, it is not easily
replaceable by other seafoods. You are
not going to have a salmon sandwich or a tilapia sandwich, it just doesn't
happen.
So,
we commissioned Information Resources, which is a syndicated data company, to
conduct a
study on that topic using household
panel data. As you can see here, here
is how tuna stacks up in the world of sandwiches. The most commonly consumed sandwich in America today--I don't
know this--is the ham sandwich, followed by PB&J, hamburgers, turkey,
cheese, hot dogs. Tuna is Number 7.
We
are pretty pleased with that fact. We
would love to see it higher, but there we stand.
What
IR did is they looked at pregnant households in their household panel comprised
of thousands of households who became pregnant prior to the FDA advisory. Then, they looked at a set of households who
became pregnant post-advisory to take a look at what happened to their seafood
consumption.
Prior
to the advisory, households becoming pregnant would typically tend to increase
their seafood intake during their pregnancy, not by a lot, but given the
relatively low starting base of seafood consumption in America, we would
consider this to be a good thing, a healthy response as they increase a food
that is really good for them.
Post-advisory,
as we saw in the Oken and the NOAA data, seafood consumption went down relative
to control, but the page I want to focus on is the next page, which shows what
happened to sandwich replacements.
Well,
sliced lunch meat goes through the roof. Prepared pasta dinners, which is food
like Chef Boyardee, microwaveable dinners, packaged turkey, hot dogs, packaged
baloney are all increasing for these pregnant women.
So,
these households, which aren't even close to eating 12 ounces a week of
seafood, they are buying on average 6 ounces or less for the entire household,
are now decreasing their consumption of seafood and instead increasing their
consumption of what we call shelf-stable convenience foods, which is
microwaveable packaged dinners, not terribly good for you, and deli meat
sandwich alternatives. I shudder to
tell you what those look like.
I
know Rona Applebaum wouldn't want me to contrast versus other foods, but it is
out there,
there it is. In fact, the next page gives you that specific comparison of tuna
relative to the other sandwich alternatives.
This is pulled straight from the USDA Nutrient database.
You
can take a look at the nutritional benefits of things like ham, hamburgers,
turkey, cold pack American cheese, hot dogs, and compare those versus tuna, and
what you will generally find is that on a whole host of major health benefit
attributes, tuna outperforms them.
What
you see there is everything in yellow is a value that is worse from a nutrient
and health standpoint than tuna.
DR.
MILLER: Mr. Stiker, could you
summarize.
MR.
STIKER: Yes, I can, sir.
Our
conclusions. At the time that the
advisory was issued, we perceived there was no immediate health risk from
methylmercury, no U.S. consumers were even close to the Faroes NOAEL.
There
is no new data since NHANES that suggest you need to make the advisory more
restrictive. On the contrary, there is substantial data that the March 2001
advisory had a dramatic impact on seafood consumption by pregnant women,
perhaps even swinging the pendulum too far.
The
advisory is a blunt tool. Even
carefully phrased language of moderate is often taken by U.S. consumers as
cease. The data suggests that the curve
has changed since the
1999-2000 NHANES. Further data suggests that pregnant women
are being driven to alternatives to canned tuna, which pose their own and
different health concerns. It is not
risk free.
Our
perception is it is not proven at this point to make the advisory more
restrictive. It appears to be
working. It is doing what you want it
to do, and the impact of driving down seafood and canned tuna consumption
further brings other real health risks.
Our
recommendations. Continue combining the
FDA and EPA advisories. We think that
is terrific to minimize confusion.
Given the extremely low levels of seafood consumption by U.S.
consumers, we think there is room even
for a more positive tone in the advisory to actually encourage more seafood
consumption by the vast majority of U.S. women who aren't eating enough.
Definitely
include the caveats that are currently in place - 12 ounces a week, ensure a
variety, eliminate the high-end species.
We believe there is no health-based reason to make the advisory more
restrictive even implicitly. Only call
out canned tuna if you are really comfortable with the health implications of
moving more pregnant women to deli meats, baloney, hot dogs, cheeseburgers.
If
you still feel you must call out canned tuna, please, do it in a responsible
way that assures consumers that both albacore and light meat are extremely
safe, and follow up to the NHANES data with current data to assess the impact
of the advisory.
It
is hurting the seafood industry, but that wasn't I am sure your intent, nor is
it something that you should be terribly concerned
with.
Public health is what you are here for.
But I can tell you it is having an impact and it is working.
That's
all for my formal presentation, but I am happy to take questions on that or the
appendix that is included, as well.
DR.
MILLER: Yes.
MS.
HALLORAN: I have two questions. The first, can you tell us the relative
omega-3 content of albacore versus light meat, is it the same, or is one higher
than the other?
MR.
STIKER: Yes, ma'am, I can. In fact, if you go to page 7, you can
contrast canned albacore versus canned light.
It is about almost 4 1/2, 5 times more omega-3 in albacore than there is
in light meat.
MS.
HALLORAN: The second question would be
if the advisory were to state that pregnant women should avoid albacore, but
the advisory positive encouraged them to eat more light tuna, or indicated that
light tuna was safe to eat, what would the impact on the tuna industry be of
that in
rough terms, or can't you speculate?
MR.
STIKER: I would be happy to speculate. First, I will attack it from kind of a public
health standpoint. I think there are
some consumers who would shift their purchases from albacore to light meat,
which would bring with it concurrent reduction in omega-3 intake.
I
think there are some consumers who are albacore loyal. You will see in the appendix, there is a
picture of what a can of albacore looks like versus a can of light meat, and it
is a very different quality product.
Personally,
I am an albacore eater and I am not a huge fan of light meat. I would switch to lunch meats, hot dogs,
cheeseburgers. Then, I think there are
a fair number of people who will not take away the message of, hey, light meat
tuna is okay, but albacore is more concerning.
I think they will take away federal warning on tuna planned, and simply
stop eating tuna altogether.
Anecdotally,
my sister-in-law is pregnant. She knows
I work for a tuna company. She told me
she has stopped eating tuna
altogether. She only eats it once or
twice a month, and she has stopped eating it altogether because she has been
hearing so much about mercury in tuna. That breaks my heart, not just as a
business person, I mean it is good for her pregnancy, it is good for her
fetus. She should be eating tuna.
DR.
MILLER: We will take one more question
and then we have got to break.
DR.
APOSHIAN: I have an 2002 annual report
of the United States seafood industry, and on this it claims that of all the
tuna landings by U.S. vessels between 1992 and 2001, for the year 2001,
albacore was only 12 percent of the tunafish caught. So, how can it be a great catastrophe if albacore consumption
went down? You have still got all the
other tunafish.
MR.
STIKER: You are actually comparing kind
of apples to oranges there I believe there, sir. I think what you are comparing is landings by the U.S. fleet,
which only comprises a small portion of the overall tuna fishing fleet in the
world.
The
data that we are looking at is U.S. consumption. So, U.S. consumption is closer to about a third that is done in
albacore, not the 12 percent, sir.
DR.
APOSHIAN: So, essentially, if albacore
was not sold, it would not hurt the U.S. fishing industry.
MR.
STIKER: Correct, which is a very small
proportion of the overall world fishing fleet located primarily in the western
Pacific fishing for light meat product.
Yes,
sir.
DR.
MILLER: I made a mistake. We have one more speaker. Thank you.
MR.
STIKER: Thank you.
DR.
MILLER: We have one more speaker and
then we can break for lunch.
Dr.
Lillian Beard.
DR.
BEARD: Thank you and good afternoon.
I
know the hour is late, I will not be taking very much time. As you know, as you have
just heard, I am Dr. Lillian Beard, and
I have no financial relationship with either agency.
I
have been practicing pediatrician in the Washington metropolitan area now for
about 30 years, and I am also an Associate Clinical Professor of Pediatrics at
the George Washington University School of Medicine, and an Assistant Professor
at the Howard University College of Medicine.
I
am here today to address my concern that the mercury advisory may in fact be
hurting more than helping pregnant women and women who might become pregnant
and could have an adverse effect on their young children.
As
has been mentioned a few times earlier today, a Harvard Medical School study
published in the August 2003 Journal of the American College of Obstetrics and
Gynecology, entitled "Decline in Fish Consumption Among Pregnant Women
After a National Mercury Advisory" concerns me greatly.
The
study showed that after reading the advisory, women who were consuming 2 to 3
servings
of fish a month reduced their
consumption to only 1 to 2 servings a month. Remember that many organizations
including FDA and the American Heart Association have recommended 2 to 3 fish
servings a week.
These
statistics alone tell us that women are not consuming enough fish if they are
only eating it 2 to 3 times a month, and if they have cut that in half, it
should sound an alarm.
While
the study was limited to the eastern part of Massachusetts, it, nonetheless,
raises the question of whether this is a trend nationwide, in which case we
should all be very concerned.
A
reduction in seafood may be appropriate if individuals were close to the 12
ounces a week recommendation from FDA.
However, market surveys continue to suggest that households are
purchasing less than 6 ounces of seafood a week for the entire household, not
just 1 individual.
As
Mr. Stiker pointed out, according to the Department of Commerce, there has
already been a 10 to 15 percent reduction in the consumption of
canned tuna over the last two to three
years. Canned tuna is not the number
one consumed seafood, shrimp is the leader, yet, the focus continues to be on
tuna, which is by far the most economical means of providing a nutritional
protein source for families, as well as being the second leading source for the
omega-3 fatty acids.
As
a pediatrician, I do follow the guidelines established by the FDA, and I advise
and counsel my parents accordingly about the importance of healthy diet and the
need to eat a variety of foods including fish.
I
encourage my parents to include fish as part of their children's balanced diet
and I discuss the health benefits for them and their children from eating
fish. In my counsel to parents, I
emphasize the importance of variety and appropriate portion sizes based on the
child's age and size. My approach to
diet and health has been to consider always balance and moderation.
Young
children already consume less seafood than adults. To make separate comments
about this may unduly scare parents
into not serving seafood at all. In the
NHANES study, there were no children who exceeded the reference dose.
I
am concerned that we may be pushing mothers and women of childbearing age away
from a safe and beneficial food, such as fish, including canned tuna. When advisories are difficult to interpret,
they seem more confusing than helpful.
The benefits of the omega-3 fatty acids for eye and brain development of
a baby are very important. Pushing
women away from fish which provides them with this essential nutrient would be
detrimental.
Our
zeal to protect women may in fact be doing them and their babies a disservice.
I encourage you to provide the public, especially health professionals,
pregnant women and women of childbearing age with simple, eat to understand
guidelines that help us to understand the important benefits received from
eating fish, and not just the scary concerns.
This
past summer, the United Nations World Health Organization gathered experts from
around
the world to evaluate the most recent
information available on mercury and its neurodevelopmental effects on
children. They recommended establishing
a safe daily intake level that is twice that of EPA. Are we supposed to ignore their advice? Does it not have some
relevance to the current review that is going on?
In
conclusion, I commend both the FDA and the EPA for attempting to provide one
message rather than two and I sincerely hope that you will be successful in persuading
the states to follow your lead, so that we ultimately hear one message, and not
52 messages.
Thank
you for your time and your attention.
DR.
MILLER: Any important questions or
comments? If not, thank you.
That
brings us to the end of the public comments.
We are going to break for lunch now.
It is now quarter past the hour, I am going to ask you to try to be back
here in 45 minutes, and then we will start discussions on each of the topics to
see
if we have any advice to offer to the
committees.
[Whereupon,
at 1:15 p.m., the meeting
recessed, to reconvene at 2:00 p.m.
this same
day.]
A F T E R N O O N S E S S
I O N
[2:00 p.m.]
FAC Discussion and Comments
DR.
MILLER: We have got a busy afternoon
ahead of us and I have tried to clarify some of the responsibilities we have
under the charge to try and simplify our work.
There
is very little we have to do with the reports from the subcommittees that we
talked about the first two days. Unless
there are some significant changes that we think should be made, the
subcommittees will get copies of the transcripts and some of the other
recommendations made, which were stylistic ones, will go the committees and
they will make whatever changes need to be made.
But
if there are no major differences between the subcommittee report and our
thinking, I would just like to accept these for the record in saying that the
full committee has reviewed the report and has referred it to the Center
Director for him to take action on the report.
I
really appreciate that. That allows us
to go right to the methylmercury, which was a direct referral to this
committee. As you all know, this was
the second time that this committee has had a chance to review the agency's,
and as you also know, there were 6 recommendations made by the FAC, of which 5
were reviewed and developed by the two agencies involved, the most important
one being that FDA and EPA work together to develop the advisory.
The
one area that did not, and I don't propose that we start discussion of it here,
but just for the record, had to do with development of blood levels and the
biomarkers for mercury. I would like to
be able to refer that back to the agencies involved and repeat again that we
think it is important for us to develop that data in order for us to tell what
the biological consequences are of exposure to levels we are talking about.
The
other recommendations all have to do with the advisory, and there are a number
of recommendations made by the various speakers, and I
asked Jean Halloran if she would take
the opportunity to make a very brief summary of some of these things.
Much
of what we talked about were in the materials submitted to the committee, we
don't have to review that. I would like
to focus on those important things that we want to tell the agencies that they
ought to do, and I have asked Jean if she would make a brief note of what some
of these things might be.
MS.
HALLORAN: This is a very intimidating
task, but I will try and summarize our discussion, the points that were raised
so far. That is what you want me to do,
right?
DR.
MILLER: Exactly.
MS.
HALLORAN: In the discussion of the FDA
exposure assessment, there wasn't much criticism or problems raised. Dr. Aposhian brought up this very
interesting study of Holmes, et al. on autistic children. We had a discussion about whether there
might need to be a special message for groups, this group and other groups, who
might
have a special situation.
In
the discussion of the focus groups, we agreed that this is a widely-used
research tool on perceptions and that it was agreed that
African-Americans were included.
Dr.
Scherer raised the interesting point that the real issue is how understand and
perception translates into behavior, and asked if there were any follow-up
plan. They didn't say that they
directly planned specific follow-up although they would do some surveying.
We
then proceeded to the presentation on the advisory, and this is where the most
interesting points, the largest number of interesting points were raised. I will just go through them chronologically
from my notes. This is not in any order
of importance or logic or sense.
It
was pointed out that mercury is an element. There was considerable discussion
on and off about portion size and that the portion size matter is still
confusing in the advisory and just
generally as an issue.
It
was mentioned at various times should there be information on what consumers
can eat. That information is not
there. The issue of verbiage was
raised, and the countervailing suggestion that the Ten Commandments is
considerably more brief and covers more ground. This came up numerous times in numerous ways, though.
The
question of should there be special messages for the poor, for special type
relations, such as Asians came up. The
order of the points and the primacy effects was pointed out.
The
point was made that perhaps we need simple behavioral rules, and the Minnesota
document was given u=as a good example of simple behavioral rules, also that
not all consumers are the same and need access to different levels of
information.
The
problem of names of fish came up again and again. Fish don't all have the same names and especially for the top
four problem fish, we need to have all the names that they might go under,
their aliases.
The
issue of what happens to the rest of the family as a result of dietary advice
was raised, also, should there be a role in communication for food stores and
restaurants and cafeterias.
I
think that is about it in terms of the major points. It is not everything, but those were the ones that came up to me
as major points.
DR.
MILLER: Thank you, Jean.
Any
comments?
DR.
ALLER: I will make one, and, Jean, I
think you did an absolutely fantastic job, because I had done something kind of
similar on my own, and will add just a couple of points to it.
I
think that what we have been looking at, if we start with the starting point
that the FDA has said and agree that the majority of the population is indeed
okay, that this message is being crafted to improve on that smaller portion of
the population for which the risk exists.
Then,
from there on, it starts to get a
little touchy because that population
is not all uniform and we have heard from a number of the speakers representing
various different constituencies, be it cultural or economic basis, or what
have you, about what that message may need to be and how best to target it.
Kind
of what I gathered from all of this is that certainly, for a segment of the
population that we are trying to reach, we would need to be saying it's okay to
eat fish as much as you want in this low concentration or this low-risk group,
and to provide that information.
I
am not saying that that information needs to be provided to everyone, but that
information does need to be available in some way, shape, or form for certain
individuals or certain target groups.
I
think that in terms of message delivery and how that is done, certainly, the
advisory that was crafted was well thought out, there was a lot of input from the
public, and it certainly is appropriate for at least one portion of this group
that is the target audience.
There
may, however, be other mechanisms and better ways to address other segments of
that population, and the behavioral model that we had handed out, which
certainly is an action item, this is what you need to do in a simpler format,
and providing a list is yet I think another means to successfully
communicate. We just need to make sure
that the message is consistent among the formats.
I
think it came up both in our meeting a year and a half ago and again today,
there is a great deal of confusion amongst species, and I am not sure that the
advisory can address all of that issue.
That, I think, is a much greater issue and extends far beyond this. But I think where possible, tilefish, I
remember from our prior meeting a year and a half ago, the question we all are
asking what the heck is a tilefish.
I
just for grins went on the Internet Monday and just typed in tilefish to see
what I came up with, and sure enough, there are lots of
different species and different names
for different things, and I am not real sure of those, which are or are they
all being targeted. So, I think that
point particularly raises some confusion and it may be if cod or halibut has
very similar types of things. I always
thought that cod was cod, but this is my ignorance.
So,
I think that some of those are also issues of great concern.
The
issue of the first and the last message I think is also a very important one,
and I don't know that we have reached agreement or consensus, but if the three
points are
indeed--there are good things, here are
things that you can do to limit your risk, and those are positively stated, and
if there is something for which we want to ensure you don't do, I would make
those our first and last points, and that gray area of a variety or what have
you more in the middle, so that again we are stressing those beneficial fish,
high in omega-3's and lower risk in mercury.
I
think that about sums it up, so I will
hush.
DR.
MILLER: Thank you very much.
DR.
BUSTA: I fully agree with the first two
comments, I think they are both covering areas. One additional item that I thought came up, or at least I was
thinking of, is the idea of multiple advisories separated by the target groups.
I
think it is wonderful to have one message from two agencies. That, I think is magnificent because at the
last meeting, the confusion between what EPA and FDA said is really bad. I like that one message there, but I think
that, depending on the targeted group, several messages have to be developed
because without an additional message for old men like me or things like that,
the simple message for pregnant women and children is going to carry across so that it won't be differentiated. If you offer several advisories, that may
enhance the differentiation.
DR.
ACHOLONU: With respect to names, it was
stated that certain fish have different names depending on the population or
the section of the
country you are coming from.
One
of the speakers suggested that what will help here is putting the names,
getting the scientific name, put it in parentheses. A scientific name is a scientific name and is very specific, so
that we know the kind of tilefish we are talking about, because somebody that
talked about tilefish, they thought about snapper and the rest of it.
You
may include the common names if you want, 1, 2, 3, but then at the end, in
parentheses, put the scientific name of the fish, and I think this would be
helpful. Thank you.
DR.
MILLER: Thank you.
Dr.
Lund.
DR.
LUND: Just two other points also on
things that we talked about or came up during the discussion with the FDA staff
and others who were presenting. One was
the issue of eating a variety of fish, to what extent that is necessary and is
helpful in limiting the amount or exposure to methylmercury.
The
other issue that I thought came up during that earlier part of the discussion
also was how specific we ought to use quantitative data in here, in other words,
going back to a body weight basis particularly I think for children more so
than for the women or nursing mothers.
DR.
MILLER: Thank you.
Dr.
Russell.
DR.
RUSSELL: Just to second what you just
said, I think the serving sizes for children has to be explicit as was
suggested by one of the speakers.
The
other thing that I think I have come to believe after hearing more and more and
re-reading the tuna guidance, I think the tuna guidance, as it is written now,
is pretty unclear of what is good and what is bad. I mean you have to read it pretty carefully to be able to ferret
that out.
Finally,
this doesn't really have to do with the advisory per se, but it has to do with
the continual need for testing of not only more fish,
but more samples of the fish we
have. If it is true, as one of the
speakers said, that there is only 6 analyses of shrimp, which is the number one
eaten fish, I think that is much too few to make any kind of any statements
with, and I just think we need a lot more data.
I
am almost wondering whether, at this point, it would be nice for EPA and FDA to
come out with a joint advisory, but I think it has to be a moderate change from
what we already have, because we are missing so much data still to come out
with any kind of thing that is more definitive or complete.
DR.
MILLER: Thank you, Dr. Russell.
Dr.
Nelson.
DR.
NELSON: I would also like to thank you,
Jean, for distilling all the commentary down so effectively. Following up on
Marion's comments about the order of the message, I think that is particularly
important because of the consistent message we heard at different levels about
unintended consequences of this kind of warning or
advisory.
FDA
and EPA considered that clearly in the design of their initial advisories and
their work with the consumer groups, focus groups. Dr. Downer mentioned it in her practice, and we heard from a
couple of other speakers about that, as well.
Part of the challenge is to make sure that a balance is struck between
protecting against potential risk of methylmercury and the good dietary and
nutritional contribution that fish makes.
DR.
MILLER: Dr. Scherer.
DR.
SCHERER: I clearly come at all of this
from a slightly different point of view, maybe a major different point of view
than most of you.
I
sometimes get accused to stepping back and trying to look at the bigger picture
more often than I probably should, but it seems to me that if I think about
what this whole process is about, you know, the agency is responsible for
collecting good data, providing sound conclusions from that data, and
ultimately protecting the public's health.
From
what I think I have heard, and
ultimately, I am getting to my level of
expertise, is that I have heard that there does need to be more data. I guess part of my message is that I don't
see this as an end product, that we arrive at an advisory and that's over, that
there needs to be continuing collection of data, but it seems to me that the
data that is within my area a little bit more, that is clearly still missing
here is consumer consumption patterns, that we don't know about those subgroups
that ultimately would become the targets of the advisory.
Now,
that is clearly difficult data to collect, but it seems to me that it is very
critical data to really be able to target messages to people that are either
high fish-consumption groups or minority groups that consume particular kinds
of fish in higher amounts than the average population.
When
we go beyond that and we assume that we have good data, and I think at this
point, obviously, there needs to be some thinking about do we have good enough
data to go on, and think I hear
the conclusion is yes, we have to go on
and do something.
It
seems to me that the agencies--and I say "agencies," EPA and
FDA--have made real strides in beginning to put together a relatively--a sound
message. I congratulate them on the use
of focus groups to help design that message, but they need to keep in mind that
that is only the very first step, and the next level needs to really be
understanding of what is it that people are reading in that message, what do
they remember from that message, and what kind of action might they take as a
result.
If
they are coming away from this message saying I am going to stop consuming
fish, then, that is not what the data would support, I think. There needs to rethinking then of what that
construction is.
The
warning that I would have is that the use of focus groups in constructing
messages can be very helpful as long as we don't let the focus group control
the content of the message, and even
if they say I don't understand this
particular aspect, that doesn't necessarily mean it should be thrown out.
So,
I am a little concerned that the message may not be reflecting the kind of
science that is behind it to the extent that the consumers will come away with
the same kind of conclusions we want them to.
The
final one, and I think Jean mentioned it, is the idea that we really need to be
clear in terms of presenting specific kinds of behavioral steps that
individuals can take. We all operate on
the simple rules, and without those simple rules, the first point, don't eat
these fish, is likely to be what people come away with would be my fear.
So,
I think there is still a lot of work to be done even when the advisory is ready
to go at this stage.
DR.
MILLER: Dr. Heimburger.
DR.
HEIMBURGER: Yes. I want to lend my voice to all those who
have said--I think essentially, I would be uncomfortable with rushing
to implement a revised advisory
especially if it were a major revision to what was already out there.
I
think I heard enough that made me think that more harm could be done than good
by making a major change, and it seemed to me that the message that we were
hearing this morning sort of could be coalesced into four major categories.
Number
one, there needs to be a better science base.
Some of that relates to the testing of fish more, maybe sharing data
with industry or receiving shared data from industry, increasing the species
detail with regard to the data, and then also, as expressed by the person from
Harvard, assessing better what really would be the net effects, what are the
net effects so far of the advisory and what might be the net effects of
revision, because it seems as though the science base on all those accounts is
not what it could be.
Second,
to make sure that the positive message is very strong. This came through again and again from a
number of different people who
testified, and I think we all ought to
be concerned that the net effect could be one of reducing potentially the
overall public health by turning people away from fish in an unintended manner.
The
third would be to create maybe a hierarchy of recommendations. The high, medium, low concept in terms of
methylmercury appeals to me; stay away from these, choose these, that maybe
somehow the positive and negative messages can both be embodied in that.
That
makes me think that the idea of either encouraging a variety of fish
consumption or mixing it up is not helpful, and I would think that actually
might need to be struck from the advisory entirely. I think there were some pretty compelling scenarios shown whereby
that might actually have an unintended negative effect.
Then,
finally, to the fourth general category was to refine the populations that we
are looking at, perhaps separate advisories, definitely separate
recommendations for children, consider high-end consumers, as well, a bit more
robust
definition of what the populations are.
If
anything--I am new to the process, so I don't know exactly why several of the
speakers have said we need to do something quickly--I am more prone as a
newcomer to the process to say why are we compelled to do something additional
to what has already been done quickly, and it seems to me that perhaps that
caution would be the more prudent approach.
DR.
MILLER: I think in terms of the latter
issue, it is pretty straightforward that there is a general and increasing
belief that there is a public health problem that needs to be resolved, the
consequences of this could be dramatic, and there is a role for the agencies to
play in that public health aspect.
I
think the agencies agree with that. I
think that what we need to do is to come out
with--there are a couple of things--one, the agencies will
review the transcript of this meeting, and not only those things that we point
out especially need to be looked at, but all
comments will be looked at for advice
to them about what to do.
What
I would hope that we would come out of this with is not simply to repeat
that--Jean did and Dr. Aller did wonderful jobs in summarizing that, but I
think that if we can come up with a short number of general recommendations,
for example, that the agencies need to develop a much larger and much more
effective research program on several areas in terms of concentration of
methylmercury in fish and agreement on the speciation of fish, and so on, that
is the kind of recommendation we need to make, and the fewer of those, the
better, that are more likely to get attention.
Dr.
Downer.
DR.
DOWNER: I won't belabor the points that
you have already made, because I think we all are in concurrence. I just wanted to bring a little bit of light
onto some additional issues.
Based
on some of the data that we received today, it appears that some additional
fish may be
needed to be added to this list,
albacore tuna for one and halibut.
Those are at higher levels than we had, at least I had first thought.
With
respect to the portion sizes, USDA uses 3 ounces of the standard portion size,
and perhaps when we talk about portion sizes, maybe that is what we would want
to look at, 3 ounces rather than the 6 to 8 ounces of whatever the nebulous
number that we are actually using at this time.
With
respect also to providing information for the different groups, I think the
physicians, clinicians, and other health care providers who provide information
to John Public should have some material provided specifically for them, as
well, so this can serve as a resource for the public, because that is
important, as well.
DR.
MILLER: Thank you.
Dr.
Dwyer.
DR.
DWYER: Thank you, Dr. Miller.
I
am a little worried about the best being the enemy of the good or the better,
and wanted to
congratulate EPA and also FDA for what
they have striven to do in the past year or two since we last saw this.
It
really has been an enormous effort and I think sometimes we get in to the
niggling details without saying that this approach of modeling I think is a
good one and the question is the model is always the issue, and I will come
back to that in a moment.
In
terms of the draft that is now available, is that likely or could it be posted
on the web for comment? I am sure the
answer is no, but basically, that would be one of way of keeping this evolving
process going forward.
My
other suggestions have to do with the--
DR.
MILLER: Wait a minute, before we go any
further, Johanna, I want to know if there is somebody here that can talk to
that. David?
DR.
ACHESON: As a relative newcomer to the
Federal Government, I would say anything is possible, but that is probably not
realistic. I think if that is a
recommendation, Dr. Dwyer, that
you feel is important, we would
certainly take it into consideration.
I
mean we are looking for comment. On the
other hand, we don't want to take forever, because we believe we have an
important public health goal.
DR.
DWYER: The reason I think it is
important is this, that I think this is an improvement over what is up there
now, and I have been developing, with many colleagues, advice for pregnant
women, and kept telling people to go to the web to find what I thought was on
the web from what we did two years ago, and nothing was there.
So,
at least from my standpoint, it is a recommendation, I don't know if the
committee shares it, but basically, we have done a lot of work, all of us, and
we are making progress. We don't have
something that is perfect yet.
DR.
ACHESON: Just so I understand what you
are recommending would be that the current draft advisory be posted for
comment?
DR.
DWYER: I am. Even though I have told you many, many things I think is wrong
with it, I
think it is better than what the
current advice is.
DR.
ACHESON: So, post it as a draft.
DR.
DWYER: Oh, absolutely.
DR.
ACHESON: As a draft for comment.
DR.
DWYER: As a work in progress, which is
a little better than what is there now.
That's all.
DR.
ACHESON: Okay.
DR.
DWYER: The second issues has to do with
the table.
DR.
MILLER: Dr. Acheson, thank you.
DR.
DWYER: One has to do with this whole
issue of nailing down consumption patterns of infrequently consumed foods that
may be of a problematic nature or perhaps of an enormously beneficial nature,
and that gets to these fishes.
Again,
I am delighted that you are thinking about doing, but I would recommend
specifically that you try to get better estimates of consumption by continuing
to refine the questions that are being asked in the HANES survey. As you know, HANES now is doing 5,000 people
a
year, so over time it really does develop
into the kind of samples sizes where you can do cuts by three or four different
things and get to specific subgroups, but it takes time.
The
items right now for foods that are not very frequently consumed are a
problems. There are ways--people at NCI
have worked on this propensity questionnaire, which are lists where they get
some idea of consumption over 30 days, that are more specific.
Of
course, we would have to have the common names, as well as the names that some
of us don't, know for these fish that we are eating. So, I would urge that that be done. Maybe HANES isn't the best place to do it, maybe it's MRCA, maybe
it's some other place, but the idea is to get better consumption data.
Dr.
Russell mentioned getting better data on the methylmercury in the fish because
you need food, as well as consumption, to get food consumption. I would urge private sources, state sources,
whatever sources--food-composition
analysis is very, very expensive, so if
the data are out there and they are collected already, why go to doing the
analyses yourselves.
The
third thing is blood levels and the variability in blood levels, so that diet
can be related to blood levels, and that is one thing that HANES can do for
you, and there may be some others, I don't know.
Finally,
continue to develop models and refine them, and specifically when people get
into risk-risk, benefit-risk, whatever, we really do have to look at every
assumption. We have to look at
sensitivity analysis because each assumption can make an enormous difference in
what is going on there.
I
know people know it, but I am just trying to get it into the record that any
analysis needs to have all of those things.
DR.
MILLER: Dr. Krinsky.
DR.
KRINSKY: I used to get questions as an
undergraduate, compare and contrast.
Some of them, one could do that, but, you know, compare and
contrast Chaucer and Saul Bellow is
impossible. So I thought I would
compare and contrast the 2 1/2 year old advisory to the present potential
advisory.
The
2 1/2 year old advisory has three points just as this one has. The first point is, to protect your unborn
child, do not eat shark, swordfish, king mackerel, and tilefish is the same.
The
second point was, you can safely eat 12 ounces per week of cooked fish, and now
the present one talks about 12 ounces of purchased fish. Now, we know that there is some difference
between cooked and purchased, so whether that is an improvement or not, I am
not clear at all.
Also,
the second point 2 1/2 years ago was that a typical serving of fish is 3 to 6
ounces, and now it's 3 to 4 ounces, so they have cut down the size of each
serving.
The
third point was--this is the old
one--there is no harm in eating more
than 12 ounces of fish in one week as long as you don't do it on a regular
basis, and the new one, I am sorry, I
repeated that.
The
third one is check your local advisories.
They had the same thing in both of them.
So,
in those three points, there has really been very little difference in the
original FDA advisory and the present one, the joint EPA-FDA advisory. What has been added now is the tunafish, and
I agree with Rob Russell that that is sort of ambiguous in terms of the
quantities that are allowed.
So,
the changes, as far as I can make out, have not been large changes, and yet it
has obviously caused us to have a full day of discussion. I think what is important to me is the
information that appeared at the end of this morning's session from the public
organizations.
The
one point that seems to stick with me is the 12 ounces of fish, cooked or not
cooked, and whether, in fact, that is safe.
I am not clear after listening to the presentations this morning that 12
ounces of any of the selection other than
the 4 that are proscribed would be a
safe level.
So,
I am very concerned about having that in the advisory as it is now.
DR.
MILLER: You mean the tunafish?
DR.
KRINSKY: Of any of the fish, because we
did hear presentations indicating that 12 ounces of a variety of the fish that
had been evaluated for their mercury content could regularly lead to levels of
mercury consumption that would be above the RfD.
DR.
MILLER: The problem, just to raise the
issue--the problem is that there are some positive virtues of the consumption
of fish that have to be taken into account, and that is part of, I think. the
risk-risk analysis that needs to be done.
Without
that, I think the nature of the risk process allows you to do this if you
recognize what the potential hazards are.
Jean.
MS.
HALLORAN: If I could speak for myself
now, instead of the group, I very much agree with
what Dr. Krinsky just said, and what I
think is important to realize is that the 12 ounce is--from Carrington's
analysis, the 12 ounce is okay if you are eating low mercury fish, but not if
you are eating medium mercury fish.
Now,
I took a look at the low mercury list that he was working with and compared it
to the fish that are consumed by the public, and if you take the top 10 fish
that are being eaten by the public, they are all on the list of low mercury
fish except for albacore tuna.
So,
you could easily construct an advisory, just change a few words in what has
been written here, and significantly change the import of it. Instead of saying you can safely eat 12
ounces, say you can safely eat 12 ounces of low mercury fish, which
include--and then list the top 10 or even the top 5 - shrimp, salmon, pollock,
catfish, cod, to take the top 5, and add shellfish, and you pretty much have
it.
I
also really think as a committed fish eater, that there are tremendous
advantages for
eating fish, and people should not be
discouraged from eating fish, but the only way, if you have a message that just
says don't eat without a part of the message that says here are some you can
eat, that you are going to discourage people.
If
you want to have a two-pronged message and make it clear that all fish are not
the same for pregnant women, then, you have to have a positive list, as
well. So, that would be my main
recommendation, that in the advisory, that fish be named, the low mercury fish
be named by name.
Then,
just a couple of other things. I agree
that we could make a recommendation to have an example of body weight and
serving size for a child, to make that clear.
I don't think that is obvious to many consumers. It is too much arithmetic.
Then,
thirdly, where it talks about tuna, so you
could safely include light tuna as part or weekly fish consumption,
because that is what the science supports.
Thanks.
DR.
MILLER: Dr. Durst?
DR.
DURST: I would like to get out of the
chemistry path and comment on some of the information that these
recommendations are based on, the analytical data. I am not sure how these data were evaluated, whether the
literature values from various studies over the years were just accumulated and
added together or whether there was actually a critical review performed on how
these data were acquired in terms of the methodology used, the protocols,
whether you are measuring total mercury, or methylmercury, or what species in
particular.
So
there are a lot of possibilities for introducing a lot of the variability I
think we see in the data that have been acquired over the years.
I
would like to suggest that if EPA or FDA sponsors any studies in the future as
far as trying to apply these data for the advisory, that a strict protocol be
provided to the contractors to follow so that we do know that we are measuring
the same quantity and can have a little more validity to these data.
Thank
you.
DR.
MILLER: Any other comments? Dr. Waslien?
DR.
WASLIEN: I just made a list of what
things one should look at. The list
became long but I was concerned that on the RfD selection process, if that
isn't also something that should be part of the ongoing research agenda, that
one also makes sure that the NHANES data on blood levels be compared with risk
of effects from it. If you are going to
be doing a risk assessment and benefit assessment comparison, that should be
part of the equation, too.
DR.
APOSHIAN: I remember that at the end or
during the last meeting, it was suggested by a number of people that since the
tunafish industry analyzes every batch of tuna that basically goes into a can
for mercury, that the FDA might want to consider looking at that data. If the analysis has been done by an approved
lab, under certain conditions, it would better than no data.
I
think it was the president of the Tuna
Association that told me during the
last meeting that they had this data, and I think he told me also they would be
glad to share it. I don't know whether
the FDA would want to depend on such data, but when you think about clinical
trial of drugs, the FDA's drug approval group, whatever it is called, accepts
data from the pharmaceutical companies if they have compiled the data and have
done the analysis.
So,
there might be a bank or a reservoir of data that is available, and I would
recommend that we ask the FDA to look into that. That is number one.
Number
two, I am just a poor country boy, I just teach and do a little research, but
from what I know about industry, I think, is that if industry had this problem
of coming out with an advisory, they would hire experts who know how to write
advisories. They hire communication
experts. The FDA, I know hires all
sorts of consultants and contracts all sort of work and I wonder whether we
could recommend that for the fish advisory, that
they bring in some kind of outside
expert to help them put together an advisory that might be more acceptable.
Third,
I am very concerned about the albacore tuna, and I hope that--I know that maybe
this may not be the time--but I hope, Mr. Chairman, we will get back to the
question about what do we do about albacore tuna.
Thank
you.
DR.
MILLER: Why don't we discuss albacore
now if we are going to discuss it.
DR.
APOSHIAN: I didn't see anyone disagree
about the analytical results as far as the amount of mercury in albacore tuna
as compared with other fish. Again, I
don't do shopping in my household unless my wife is sick. She had broken her ankle, so I stopped by
the tuna shelf in the local market, and albacore, I saw it, because I was never
aware of it before the last meeting. So
I saw it and said, it doesn't even say
tuna, it says albacore.
You
know, I am supposed to have a Ph.D.
and M.S., and I didn't do know that,
that albacore was tuna or is considered to be tuna. There seems to be some need, again, of educating the public about what albacore is. I do studies all over the world, and every
time I see sick children who are exposed to arsenic and mercury, whatever, I
feel very badly and can't help but relate them to my own personal background,
namely, my grandchildren.
I
certainly, at the present time--well, I have told my granddaughter who is of
childbearing age, which I hope she won't have one for a long time, that she
should be very, very careful about the tunafish that she eats, that she should
probably have one sandwich a week, which is plenty, and I also told her just
the other day when I was in Boston, that she shouldn't eat any albacore. But I have told her she should eat fish, and
that fish is very, very good for her, and that message gets across.
It
gets across probably because I make a point of it, and so I am asking whether
the FDA could make a point of getting experts to get that
message across, because I certainly
would hate to think--I don't like the idea of American children or American
pregnant women or women of childbearing age eating a lot of albacore. I think that should be a very important part
of this discussion.
I
know we are going to have to make compromises on tunafish and other things, but
the albacore seems to me--as a toxicologist, seems to me to be a potential
source of danger, but there are nutritionists here who can talk more about
that.
DR.
MILLER: Jean.
MS.
HALLORAN: This also raises the question
of what should be on the Do Not Eat list, and there doesn't seem to be a firm
criteria for how something gets on that list or possibly gets taken off it. I think that we have seen from
the--if we can ever figure out what
tilefish was, we might be able to determine that with new data, perhaps it
doesn't have as much mercury as was initially thought or perhaps there is some
subspecies of it that does and that subspecies or a
particular local variety could be
identified.
On
the other hand, we have pretty much confirmed that albacore tuna is high and
grouper and orange roughy aren't looking very good. They appear to be higher than the tilefish.
So,
perhaps a recommendation could be to FDA to establish a criteria or cutoff for
what goes on the Do Not Eat list and to revise that list periodically as data
comes in with serious consideration as to whether albacore tuna should be on
the list.
DR.
MILLER: Well, that would apply also to
the moderate levels, as well. In other
words, if you are going to make a list, you need to have criteria to decide on
which of those lists things go. It is
not just the high-dose fish that we have to worry about. We have to worry about the fish with
moderate doses, as well, too, the ones that you are effectively saying you can
eat it, but don't eat it too frequently.
MS.
HALLORAN: Although at the moment, I
don't believe that exists as a public list, does
it, the middle list?
DR.
MILLER: It is not in the advisory. The advisory just has the Don't Eat part of
the list.
DR.
ACHESON: The high, medium, low criteria
were in the directions to the peer-review group.
MS.
HALLORAN: My understanding is that
there is data that say high, medium, low, but I don't recall FDA giving any
instructions on how much you should eat from the medium and low groups.
DR.
MILLER: David.
DR.
ACHESON: Yes, just to clarify that
point, the data is on the website. The
high, medium, and low, for the purpose of the exposure assessment, as Dr.
Carrington mentioned yesterday, were arbitrarily chosen to put light tuna in
the low category. So essentially, the
0.12 was the cutoff for that, and everything below went low, and everything
above went medium except for the 3 high, in fact, because he didn't use tile
fish in the model.
DR.
DICKINSON: This is just to reiterate
the point that was already made about the need to clarify the reasons for
classifying things in different places, because if we are talking about adding
albacore tuna to the list of Don't Eat things, it actually, on their list, is
not at the top of the middle mercury category, and is not that much above the
couple that are just below that.
So,
I think there would need to be a reason for selecting the cutoff, and some
uniformity about what was on the list.
DR.
APOSHIAN: It might be the idea of
consumption, that they probably eat more of that than some of them above.
DR.
DICKINSON: That may be true, but we
don't have very satisfactory data from NHANES as to whether tuna was figured
largely in the individuals who were at the top of that distribution either.
DR.
DWYER: Do we know that? Do we know what that top 5 percent ate?
DR.
DICKINSON: No.
DR.
DWYER: It wasn't in HANES anyway, was
it?
DR.
DICKINSON: Yes, it was, the 8 percent
was.
DR.
ACHESON: That was part of the problem
is that we really don't know what those 8 percent ate, which is what I said
earlier this morning, that that is part of the goal is to figure out who they
are and what they eat, so we can develop a targeted message toward them.
DR.
DICKINSON: But we don't have
information now to say it's tuna.
DR.
ACHESON: No, we do not.
May
I just make one other comment in relation to that, and that is, in terms of the
exposure through market share versus the amount an individual consumes, because
obviously, the critical issue is how much is on your plate.
We
know that a portion of albacore may be no different from a portion of
salmon. The critical issue would be, as
we know from the data, that there is a lot more albacore consumed, and tuna
consumed, than there is salmon. So I think
that if we are going to try to set
criteria for high and medium, we have got to define that very carefully.
DR.
MILLER: That is reasonable. That doesn't necessarily take away from the
fact that this could be very useful.
DR.
ACHESON: I agree, it could be useful if
it could be done, yes.
DR.
MILLER: Dr. Aller.
DR.
ALLER: I think that point gets back
again to our definitional issue of what do we mean by high, are we talking
about high risk, are we talking about high concentrations, and when I talk
about risk, I am thinking not only of concentration but frequency of
consumption.
I
think as we talk amongst ourselves, we need to be keeping that clear in what we
mean and in our advice back to FDA and EPA.
DR.
MILLER: Dr. Callery.
DR.
CALLERY: Thank you. I think we have often now looked to a
scientific basis for what we are making our decisions on here, and it looks
like
we are not having a good definition of
what makes the list and what doesn't make the list, and where it fits on the
list.
I
think that that becomes even more difficult in the process of saying what is
the criterion for putting an item on the list for the advisory or off the list
for the advisory.
I
think there is a negative impact to the public to change your mind after a
while, and you ought to have a very good criteria set up to do that. I know, at least in my neighborhood, there
is a distrust of scientific information.
The concern is, you told me I could eat it, and now you tell me I
can't. Can't you make up your mind?
So,
I think to do that kind of idea of saying you can take it off the list at some
other point, you had better have a really good rationale and criteria
established ahead of time rather than you will figure it out later.
The
issue about albacore, of putting it on the list of banned ones would be I think
a very confusing thing for the public because some people
think of tuna as tuna, and I that it
would be difficult to say, well, this one type of tuna is banned, but this
other type is just fine, and then the idea that, in fact, in a few months you
might decide that, in fact, it went down from 0.3 something to 0.29 and you
took it off the list, would cause a lot of trouble.
I
think the issue here is, I would not recommend that we put the albacore on the
banned list. I think we need to address
the fact that it is a very popular fish and we should do the benefit-risk
analysis to determine with this important food, where it fits into the scheme.
DR.
MILLER: Dr. Dwyer.
DR.
DWYER: Well, the good things is there
is no chronic wasting disease of tunafish, but I think there is a way to get
around this. The advisory for the
consumers? Who knows? But I think there is a little algorithm that
could be used if we could just come up with what is medium.
You
know, are you pregnant, at risk, nursing; if yes, then, the question is do you
eat
shark, swordfish, king mackerel or tile
fish, using the common names, and if the answer is yes, then, stop it, and if
no, do you eat over 6 ounces per week of game or sport-caught fish, and if yes,
then, watch not to eat more or check your local advisory.
If
no, then, you never eat any of those, then, we get to the issue of trying to
make it a positive message for consumers, and the question becomes what the
recommendation is for low mercury fish.
Doug pointed out there really isn't any if we are talking below 0.1,
right?
DR.
HEIMBURGER: Or at least no upper limit
for low mercury fish.
DR.
DWYER: You can eat as much as you want.
DR.
HEIMBURGER: With the exception of body
weight.
DR.
DWYER: Or 12 ounces.
MS.
HALLORAN: What did you mean when you
said there isn't any--
DR.
DWYER: That you could eat a lot of it
without--
DR.
HEIMBURGER: Even 12 ounces shouldn't
necessarily be considered a limit for low mercury fish in non-pregnant people
who don't eat game or sport-caught fish.
MS.
HALLORAN: In non-pregnant people.
DR.
HEIMBURGER: Right, non-pregnant.
MS.
HALLORAN: In pregnant people, it
should.
DR.
DWYER: There would still be a limit of
12.
MS.
HALLORAN: I believe so.
DR.
HEIMBURGER: Oh, I am, it is in pregnant
people.
DR.
DWYER: It is only in pregnant. Then, the only one I can't fill out on this
would be, no more than 6 ounces per week of the medium mercury fish, and 12
ounces would be the limit for the--
DR.
HEIMBURGER: Why should there be a
12-ounce limit for the low mercury fish
in pregnant women?
MS.
HALLORAN: Because they all have
mercury.
DR.
HEIMBURGER: But if they are low--
MS.
HALLORAN: Not that low.
DR.
HEIMBURGER: Some are, some are
nondetectable.
MS.
HALLORAN: No.
DR.
MILLER: Well, this isn't getting us
very far.
DR.
DWYER: Thank you, Dr. Miller. It strikes me that it does. You have got light tuna over in the 12-ounce
side, and you have got the albacore in the 6-ounce side, and I think it does
get you someplace. And no chronic
wasting disease.
DR.
MILLER: Well, this issue concerning
albacore, that was the question that was being asked, rather than the other
fish. It seems to me, having been
raised, that question needs to be--we need to come to some recommendation or
else we could say we can't make a recommendation because we don't have the data
to support a recommendation.
Even
if we said that, it seems to me that what we need to do is to recommend that an
analysis
of albacore tuna be a priority issue
and whatever research activity that FDA and EPA take on.
DR.
APOSHIAN: But I thought we had the
analysis.
MS.
HALLORAN: There is plenty of data.
DR.
APOSHIAN: I think there is plenty of
data about albacore. The question is
what are we going to do about it, are we going to accept that data, are we
going to move ahead with it, or are we going to keep talking about it.
DR.
LUND: You still get back to the
question, though, of what is the net ingestion, not the parts per million in
the fish, and if you look at the data on page 13 of their table under Tab 8,
Table 2, you look at albacore versus the light canned tuna, the albacore is 3
times higher--
DR.
DWYER: We are having trouble. What are you--
DR.
LUND: Tab 8 is the paper by Carrington
and Bolger. If you look on page 13,
there is a table, and that is the one that I think some of our colleagues from
FDA have referred to,
to say, look, there is a lot of data
out there. The data we showed you in
this little special table only happened to compare old data with new data.
So,
if you look at line 6, the albacore canned tuna is approximately 3 times higher
in concentration, parts per million, measured as mercury--not methylmercury,
but measured as mercury, I presume--and its disappearance, its market share,
however, is approximately a third.
So,
from an impact level, if the market share data reflect what happens across the
population, then, the exposure of the population to methylmercury through tuna,
either albacore or light tuna, is the same approximately.
DR.
APOSHIAN: But not the exposure to the
individual.
DR.
LUND: That's to the whole population,
that's correct.
So,
the question comes back again to what is the actual consumption of tuna by
pregnant women, women nursing, or women likely to become pregnant. The answer is we don't know. So why
would we suggest banning something
because, at this point, the data are incomplete? What happens if you came back with a result, and you went into
the NHANES data or you went into some other method of getting those data, and you found out, in fact, that they don't
eat a lot of albacore tuna. Now, would
you have to come back and change your advisory and say whoops, we made a
mistake because now we have more complete data. We now have more complete data, so we are going to change the
recommendation again.
DR.
APOSHIAN: You are talking about
banning.
DR.
LUND: I didn't mean banning.
DR.
APOSHIAN: Well, whatever you are
saying.
DR.
LUND: No; I meant to put it into a
Don't Consume category.
DR.
APOSHIAN: Again, I am not talking about
a Don't Consume. What I am talking
about is in the prior advisory, no mention was made of tuna as far as a word of
caution is concerned, and what
I am suggesting is that some kind of
statement be made that albacore should be eaten under certain restrictions or
limitations. I am not saying it should
be banned. A pregnant woman should be
warned that albacore has more mercury in it than light tuna, or lower than
whatever the common fish is.
DR.
LUND: That is number two in the
advisory.
DR.
APOSHIAN: Pardon?
DR.
LUND: That is directly addressed in the
advisory.
DR.
APOSHIAN: But it wasn't in the old
advisory.
DR.
LUND: No; but the new advisory.
DR.
MILLER: With regard to the new
advisory.
DR.
APOSHIAN: So, what I am asking, there
is no question--
DR.
LUND: But I thought we were discussing
whether albacore should be put into that category with swordfish, et
cetera. That is what I
thought you were getting at.
DR.
APOSHIAN: I gave that up a long time
ago, knowing the feelings of this committee.
What I am asking for is a word of caution of some kind about albacore
itself. I don't have the thing in front
of me, so, if it says albacore, fine, that is certainly a major step forward
from the last, old advisory.
DR.
MILLER: Dr. Scherer, did you have a
comment you wanted to make?
DR.
SCHERER: My comment is based on the one
that we discussed earlier, about the recommendations over time. That clearly is as problem and one that I
think all of science faces. It seems to
me that any advisory that goes out needs to have some level of small disclaimer
saying, based on what we know today.
For
me, that is beginning to try to educate the American public that science, by
its very nature, changes and we want that to happen rather than coming out with
authoritative statements that this is the way it is, and then in
the future, we change it, and, in fact,
do confuse people. So I think any
advisory needs to begin trying to put a context on it based on what we know
today.
DR.
APOSHIAN: As a point of clarification,
since no one brought it up, saying it's not in the new advisory, under,
"To protect your baby, follow these three rules," and I don't see
tuna or albacore mentioned anywhere in those three rules.
Later
on, if you get to it, frequently asked questions about mercury and fish, under
No. 2, what is tuna? It says that tuna steaks generally contain higher levels
of mercury than canned tuna. Now, I am
not even sure I see the word albacore in there--yes, I guess it is. I am
sorry--tuna steaks and canned albacore.
But it certainly does not say, to protect your baby, don't eat a can, or
5 cans of albacore a week. I would like
to have a word of caution in there.
No
one I think believes that they can ban the canning and selling of albacore
tuna, but I
thought our role as an advisory
committee was to advise the FDA from the knowledge that we may or may not have
as far as the public health is concerned, and I would certainly--knowing the
pregnant women that I know, young ones, I would certainly like them to know
that albacore should be of concern to them, and this doesn't do it at all as
far as how to protect your baby.
DR.
DICKINSON: I think in response to that
comment and many others that have come up,
that Johanna had a very good idea just a moment ago, which is what is
really hanging us up and what was commented on by many of the speakers today,
is the idea that you can eat up to 12 ounces of anything other than these four,
and that appears not to be the case.
So,
Johanna's idea of having a category of which you would have a limit of 6 ounces
of the medium level fish, and then another category of the low mercury fish for
which you could go up to 12, I think makes a lot of sense.
I
don't see a justification except in
share of the market, and I accept that
that is something that needs to be considered, but I don't see a justification
for culling albacore out uniquely, out of that middle category.
DR.
APOSHIAN: As long as we have three
categories, which we don't have at the present time, as long as we have that.
DR.
MILLER: Did you have a comment, Jean?
MS.
HALLORAN: I agree with what was just
said. I agree that three categories
would solve the problem, and the statement about tuna, I am particularly
concerned about the last sentence, that says, "You can safely include tuna
as part of your weekly fish consumption," without specifying that truly,
the only kind of tuna that you can include is light tuna.
DR.
DICKINSON: Or a lesser amount of
albacore.
MS.
HALLORAN: Or a smaller amounts of
albacore, right.
DR.
MILLER: Dr. Aller?
DR.
ALLER: No; Thank you. I think the
points have just been made.
DR.
MILLER: Dr. Downer?
DR.
DOWNER: I am going to talk from the
public's perception, John Q. Public, the consumer.
I would suggest that we ought to think
about is portion size. The other thing
that I think this committee may want to think about is, is there a group that
we can classify, a group of fishes that you can eat any amount of, that there
is no limit.
That is the group I am interested in,
which means the group that can eat as much as I want. That is the group I want
us to talk about if we get a chance.
DR.
HEIMBURGER: That will address the high-end users.
DR.
DOWNER: I am interested in high end and
low end, just tell me that you can eat
as much of this as you want, that is all I am interested in.
DR.
HEIMBURGER: But it would avoid alarming
high-end users that they need to drastically reduce their intake of seafood.
DR.
DOWNER: I'm sorry; I didn't get
you. What did you say?
DR.
HEIMBURGER: If you were to give a
category within which you could eat as much as you wanted, then, you would
avoid alarming people who are already high-end consumers of fish.
DR.
DOWNER: That's right, but also for
those who are interested in eating fish, this is another way to say, enjoy it, all of these kinds of things. Is the such a group?
DR.
HEIMBURGER: But is it possible to
create such a category even for--that are low enough to allow that statement.
DR.
MILLER: Jean?
MS.
HALLORAN: I think the best clue on that
is if you look again at this Table 2 that was just referred to, I think you would have to probably stick to
like the bottom 3 or 4 items on the list.
It would be a very small list.
Sardines? Pregnant women like
strange things.
DR.
HEIMBURGER: Would you want to extend it
up as far as salmon and which would include
shrimp. That is the most consumed populationwise.
MS.
HALLORAN: We need someone to do the
calculations on that for us.
DR.
MILLER: Why can't we make a
recommendation--let me put it this way--we have come close to the time when we
have got to come up with some of these recommendations, and certainly one of
the recommendations ought to deal with the format. Much of what we are talking about are format issues, and among
them is the development of the three lists indicating the concentration of
mercury.
Another
thing might be the indication on those list which are the ones--well, let me go
back a bit. Another thing is that we
have got to recommend that the advisory be more positive in many ways. It is very negative in many areas. We could indicate a group of fish in the
lowest concentration area can be consumed. That is the kind of recommendation I
think we are going to have to make.
We
are also, I think, going to have a
research recommendation. One of the things we ought to be saying in
that research recommendation is this is an important enough issue to be a very
high priority to the agency. That means
that they ought to be spending more money on this issue than they have been
spending.
Among
these, also in terms of research, we ought to reemphasize the importance of
trying to develop a collaboration with the industry, who I am sure have data,
and there are ways of developing this data which would not pose difficulty with
the companies that are providing that data, like what the agent is with lead in
condensed milk. That was a very
successful program to reduce lead in condensed milk. These were data that
were collected by NSDA who acted as a broker in making sure that FDA--the data
was not used for any regulatory purposes.
There
ways of doing this.
But
those are the kind of recommendations, and it seems to me that the issue of the
albacore thing, it can be at least partially resolved by
having three lists, one of which, the
moderate one, is fish to be consumed in restricted consumption of fish.
Dr.
Krinsky.
DR.
KRINSKY: Thank you. Referring back to this Table 2 in the draft
document of December 24th, 2003, the right-hand column has three categories,
high, middle, and low. The title of
that column is Advisory Group. Was this
decided on at the last meeting of this advisory group? What is the basis for this?
DR.
MILLER: I have no idea. David, can you clarify it for us?
DR.
ACHESON: Yes, I will try to. That was the arbitrary exposure assessment
along with the definition of high, medium, and low. The low was modeled around the light tuna, taking that as that,
and the low, would be low.
DR.
KRINSKY: Then, would it be possible for
the recommendation to say no fish consumption in the high group--this is for
the pregnant--no fish consumption in the high group, maybe 1 fish
consumption for the serving that is
from the middle group, and I don't know how much from the low group. Would that then become unlimited from the
low group? Somebody would have to go
through the calculations to figure out how much that that group could consume.
I
am also not sure whether the arbitrary high grouping is really appropriate,
because it seems to me the grouper and orange roughy are really quite high.
DR.
MILLER: I think if we recommend that
they establish these three groups and the subsequent criteria for them, you
would have to look at the entire listing of issues when we develop those pages.
DR.
KRINSKY: Well, they would only have to
look at the fish for which there is data, though.
DR.
MILLER: Yes; that's all they can do.
DR.
KRINSKY: I assume that that is what
this table is. Were there fish that
were not included in this table?
DR.
ACHESON: I think essentially, no. Tilefish, frozen tilefish, as we discussed,
they are not in there.
DR.
MILLER: Dr. Aller?
DR.
ALLER: I would also just to make
another point. Getting back to the
point you raised about collaboration with industry, there are also state
laboratories that are out doing NRs. We
do mercury analyses on a regular basis and would be very happy to--and, I
believe have provided, whether or not they have been used in any of these risk
assessments. But we have those data,
and share methodologies, et cetera, and I know that has been an ongoing difficulty for FDA over a number of
years. I really think we need to get
it, not just for the safety, but for so many more--we need to get to the point
where FDA can accept other data.
DR.
APOSHIAN: Not as a written
recommendation, but could we sort of ask the FDA and the EPA people that, when they give us a chart like this, they
sort of give us a range of standard
errors, some idea as to what the figure
means, because, you know, for a graduate student to give me this kind of data,
it just would be absolutely unacceptable without some range or statistical
analysis.
DR.
CALLERY: I have a suggestion for
something that might be added as a recommendation that came out of the
discussions of the last couple of days was the use of website information on an
advisory, the recommendation that the website for further information be listed
on the advisory.
DR.
MILLER: Dr. Heimburger?
DR.
HEIMBURGER: Just back to the question
of whether there are three groups and whether there will be an unlimited group,
could we at least recommend that they consider the establishment of a fourth
group, which may be just called "very low," from which it might be
possible to consider not placing a limit on consumption?
Just
end it looking at criteria and deciding where the cutoffs will be between high
and medium, medium and low, to consider a third cutoff
for a fourth category of very low.
DR.
MILLER: We can do anything. We can make any recommendation we want. It is up to the agencies to implement it.
DR.
HEIMBURGER: Right. I am just suggesting--
DR.
MILLER: Given the fact that among
the most common recommendations that
were made in various presentations was to develop a simple approach to the
problem, so that anybody could understand it, it seems to me we are going in
the opposite direction.
We
are making things more complex, not that we don't have to. As long as we couch these recommendations in
terms of to have the agency consider these things, because something has to
give sooner or later, particularly as we develop and build more into these
things.
When
I think, for example, we haven't discussed at all, and I would suggest that we
do, that we really consider the possibility of having multiple advisories for
different population
groups. It simply makes sense to do that.
Having
said that, that just makes it more complicated. But there is plenty of experience of doing that. Every dentist's office has a pamphlet in it
that tells different groups of people what to do about their problems with
their teeth. Well, we are worrying
about mercury, not teeth--maybe we are worried about teeth, I don't know.
DR.
HEIMBURGER: The amalgams are in there.
DR.
MILLER: Johanna?
DR.
DWYER: I think that is a good idea, and
I certainly don't want to quote Vladimir Lenin in a government advisory group,
but I will. Remember he said,
"First, socialism in one country," and first, we need an advisory,
one advisory, and then we can get to these multiples ones.
It
seems to me one thing that might help clarify, back to Dr. Aller's issue, is
that the very low fish are fine if we know the frequency of consumption, we
have some kind of population-based
data where we know frequency of
consumption. Yes; there will always be
demand for the lady, like the case in the New England Journal where the man ate
40 eggs a day. Then your bets are all
off. The basic point is if most people don't eat very much of very low ones,
maybe that is the way.
DR.
HEIMBURGER: Salmon and shrimp are
there. Shrimp is at the very top, the
number-one one, it could be in that group, and salmon is not far behind.
DR.
DWYER: If that is what market-share
means. Is that what market-share means?
MS.
HALLORAN: It is per capita. They are ranked by pounds per capita. Shrimp is number one. Tuna is number two, and salmon is number
three.
DR.
DWYER: I am sorry, so it's
disappearance data, or is it consumption data?
Do people eat it or is it what was on the market? It's disappearance data. So, those data are, with all due respect, if
it's disappearance data, those data are probably higher amounts of mercury than
the actual amount eaten, right?
DR.
HEIMBURGER: It's just
market-share. Is some of the
market-share going to our cats?
DR.
DWYER: There is always waste. There is always waste between what is on the
market and what you eat.
DR.
CARRINGTON: It is supposed to be
market-share. I don't know how well
they do it. Those aren't my estimates,
so I can't tell you exactly how they are done, But they are supposed to be
human use, so it should not include pet food.
DR.
MILLER: Somebody handed me a list here
of fish that would meet the standard of being able to consume as much as you
want. They are very low levels.
DR.
CARRINGTON: Well, I can volunteer to do
another simulation. I can add another
simulation to my series. I can do a no
high, low only, and then I can do a very low only. I guess the question is where do I pick my cutoff, and I guess I
heard salmon. I guess I can take
sardines as another one. I can do very
low, and very, very low.
DR.
HEIMBURGER: A level of 0.03, according
to Table 2, though, there is a bit of a gap that the 0.03 might fit into
without coming close to any high consumption fish that are just over that
level.
DR.
MILLER: Well, I don't think we ought to
spend too much time or any more time.
We are trying to work out what we want the agency to do in the first
place, and we don't have the time nor the data to be able to do that, but at
least we can make a recommendation to the effect that the agency should
consider establishing a very low level for the purposes of determining those
fish species that can be consumed in reasonable amounts. But I want to say, as much as you want, that
always gets you in trouble.
DR.
HEIMBURGER: You get into the obesity
issue. The language would have to be
chosen carefully.
DR.
BUSTA: Earlier, Dr. Halloran indicated
that if one made a modification to the current advisory, and included, in addition
to the
top 3, we have 4 there and the tilefish
could exclude the golden tilefish, which comes in as a low one, probably is a
different species, and if one added grouper, orange roughy, and albacore, one
would have a top 7 to exclude for this group, and then name the bottom 10--I
wouldn't even limit it to 5--I would name the bottom 10 including light tuna as
to what you shouldn't do and what you should do.
That
seems to me to get us off the dead center. Now, If you want to add this group
of reasonable unlimited, and the others 12 ounces, but to me, that seems to
give names, and if somebody is eating fish sticks, they have got to just roll
the dice.
DR.
MILLER: What is in fish sticks?
DR.
BUSTA: I don't know what is in fish
sticks.
DR.
DOWNER: Bread.
DR.
APOSHIAN: Whatever is cheap.
DR.
DOWNER: Mostly bread.
DR.
APOSHIAN: Are we recommending three
separate advisories or are we
recommending more than one advisory?
DR.
MILLER: I would think we are
recommending more than one advisory.
DR.
APOSHIAN: We are. Good.
Thank you.
DR.
MILLER: That is the idea, that there
would be more than one advisory designed to be aimed at a specific population.
DR.
DWYER: And what are these different
advisories for, for whom?
DR.
MILLER: Different populations.
DR.
DWYER: What different populations,
women who are pregnant?
DR.
MILLER: I am sure a male, for example,
could certainly eat more, and should eat more, fish, and we don't have to worry
as much for them.
DR.
DWYER: I don't see why you can't have an
algorithm that deals with all of them, and then develop the communications
tools, which I certainly am not competent to do, and I might add that there are
many others who are not competent to do, and
leave it at that. I mean our expertise is not communications.
DR.
MILLER: What we are looking for is a
simple way of dealing with this, at least I think that is what we are looking
for.
DR.
DWYER: Right.
DR.
MILLER: And if you try to put
everything into the same mode, you end up with a tree that doesn't necessarily
prune very well.
DR.
DWYER: I don't think you do. I think you end up with an algorithm like
that sheet that I proposed.
DR.
MILLER: I was going to say that this is
one more approach to the problem. This
isn't the only approach to the problem.
To ask people to sit down and fill out a form to decide how much fish
they are going to eat is a bit much.
What
I would say is, what I would like to do is include this in the record as an
approach that the agency might choose to select. I have my own problems with algorithms like this.
Dr.
Russell.
DR.
RUSSELL: I actually agree with Dr.
Dwyer. I think that to have one
advisory is what we need, and then to have different communication tools to be
targeted to parents of young children, to professionals, and to other groups, I
don't know. I don't know whether Asians
would need a different advisory or not--a different educational tool or not,
but I do believe that one advisory is really what we want to lean toward, and
that would be the simplest, most clear message to the population in general.
DR.
MILLER: David, did you want to make a
comment?
DR.
ACHESON: Yes. Thank you, Dr. Miller. We
were just having a brief discussion of some of the complexities that would be
involved in developing multiple advisories, and also the complexities involved
in trying to define high, medium, and low.
Certainly,
it is obviously the committee's prerogative to say that is our problem to deal
with, but I fear that if we were to set a divide,
criteria that was specific for high,
medium, and low, particularly medium/low, obviously, there is a big issue
whether a fish jumps from medium to low, and if there is going to be a defined
point, and we are going to continue to test.
I have already said that, and you are certainly recommending that we
continue to do that.
I
worry that we would have another tilefish example where we thought some
something was high, and whoops, you know, goldface tilefish or golden tilefish
are low, maybe we need more data.
I
am just concerned that we are going to get, as you pointed out, Dr. Miller,
increasing complexity and increasing concern about that, and I really just
wanted to make that point, that the science may be some good ideas, but it is
certainly, in terms of trying to translate this into a simple message, going to
be difficult.
DR.
MILLER: Without debating the issue, it
seems to me that what should be done is to try it, in other words, as far as
the different groups
are concerned, the data would have to
be worked out, and the endpoint would be what would be the exposure, based on
your exposure information.
I
think as far as the multiple advisories are concerned, again, the question is
how different would these advisories be.
DR.
ACHESON: Well, we would have to look
into that. I mean again it would be
nice to have a recommendation as to--if we are doing multiple advisories, do we
break out young children from pregnant women and women who may become
pregnant? That wasn't clear to me from
the discussion.
Obviously,
adult males are a different category, sure.
But if we are going to go down the road of multiple advisories, just
exactly what would the recommendation be of what they should be would be
helpful, and what would come first, what is the most important one to tackle
first and get that out.
DR.
MILLER: I think an answer, to start on
the second. My own recommendation would
be pregnant women or women who might become pregnant.
Dr.
Scherer.
DR.
SCHERER: I had a couple of points. It seems to me that the issue is not multiple
advisories as much as it is putting it in a format that is better understood by
the multiple audiences, so that the idea is to identify those target audiences
that are at the highest risk, take this common advisory that everyone has
agreed upon, and make sure it is in a format so that they understand that, that
content.
So,
it might be a general advisory that is available to the public but targeted to
make sure that pregnant women understand the importance of the parts for
them. So, it is more of a design issue
as opposed to changing the content of it.
I
had one other thought in terms of a recommendation related to this. It seems to me that once the tinkering with
the content of the advisory and getting it to a point where it seems to be
appropriate, I think the next step really needs to be, in terms of a
recommendation from this committee, that it then be taken to audiences again
to understand what is it that they
remembering from it and what is it that they translate into the behavior, so
they have a better understanding of those audiences before it really is
distributed widely.
DR.
MILLER: One of the thoughts of our
charge was to agree, or disagree, for the
development of an outreach and educational program for these things. Do I take it, given the nature of our
discussion here that the committee agrees with that, that the agencies ought to
develop those programs?
DR.
HEIMBURGER: Yes.
DR.
DWYER: I have to say I think those are
wonderful ideas, but first, we have to find out what is in the fish, and how
many fish that people are eating.
DR.
MILLER: Well, that is the other
question. The other question is shall
we tell the agency to delay in releasing an advisory at all until all this data
is together or do we suggest that they go ahead with the changes that have been
suggested, and that further testing
needs to be done, but go ahead with the
idea that they are going to put it out and have to change it later on when new
data comes on.
That
is the balance that we are running into here.
This could be taking several years.
DR.
HEIMBURGER: Could we come up with a
very short list of things that we think ought to be considered for very,
almost, you know, for accelerated implementation, but just very minor things,
and rest should wait until more data are available?
DR.
LUND: I actually thought that is where
we were going. I thought that EPA and
FDA were charged to look at a specific advisory to a specific subgroup of our
population; pregnant women, women nursing, and women that may be about to
become pregnant, or wanting to become pregnant or something, but in any event,
that these special subgroups and small children, and babies, and they were to
look at those advisories from those two regulatory agencies and come to a
common
understanding of what the advice should
be.
I
haven't heard anything that suggests that they should not continue to do
that. What I have heard around the
table that there are some things in here that we think need to really be
examined, and that is, the issue of meal size or the portion size, the issue of
naming specific species and making sure people understand what they are, making
sure it is absolutely clear that there is a strong, positive message in here,
it is not just a negative message first, et cetera.
So,
I think our recommendation is to proceed in going through this process based on
what you have heard here, coming out of the comments of the various members of
the Advisory Committee, and continue to work, however, on the database both
with regard to populations and what they eat, what the distribution of the
consumption is of fish and fish products, and with regard to the database for
the levels of methylmercury in fish.
That
is where I thought we were coming out at.
DR.
ACHOLONU: I thought that somebody
suggested that we prepare this and put in on the website as a draft and leave
it there with the understanding that it may be undergoing some changes as
permission becomes available. I thought
a suggestion was made that we put this on the website.
DR.
MILLER: The suggestion was made to put
it on the website, but it doesn't indicate necessarily how long the agency will
have to wait. I mean what is concerning
me is that we can continue to increase the amount of data that we think we need
in order to deal with this.
The
question is at what point do we say that can continue, but we have got to get
on with the process of coming out with an advisory of some kind, and you just
keep making the risks bigger and bigger and bigger.
DR.
ACHOLONU: If we indicate that, as of
now, there is going to be information available, because things change, and the
list that we have, the high, the medium, and the low, there is a
possibility that they can change with
time.
DR.
MILLER: I agree.
DR.
ACHOLONU: So, we may not come up with
something that is finite at this time, but there should be something that
people can use as guideline at the present moment, just indicate that it is not
final and that as new information becomes available, it will be updated.
DR.
MILLER: Well, several members of the
group are going to be leaving in the next 15 to 30 minutes, so we need to come
to a conclusion. I can one make
recommendation to facilitate this.
When
the transcript is available, we can go through the transcripts and try to make
a list of the recommendations that we made, and we will share it with the
committee for their comments. Let's try
and focus on the most important issues rather than every one of them.
DR.
WASLIEN: If we did it as individuals
and voted on which ones we thought were first priority, second priority, you
know, when we get it back. Then you can
get a democratic process.
That is not necessarily the correct
process, but that would help us in sort of prioritizing afterwards.
DR.
MILLER: We can indicate on the list
where we think this ought to be in terms of priorities, first, second, or
third.
DR.
WASLIEN: Yes.
DR.
MILLER: Dr. Durst?
DR.
DURST: I agree with Dr. Lund that the
primary issue for this committee was to determine what could come out as a
unified document from the two agencies, and I think we have a good basis for
this in the advisory that is here. Once
the comments of the committee are incorporated into this, and it is put on the
web for further discussion, I think we are off to a good start for this
document.
I
also agree with Dr. Lund that this should be aimed at the individuals that were
in the original advisory, that we focus in on this particular group.
DR.
MILLER: That is true.
Dr.
Krinsky?
DR.
KRINSKY: In the first place, I don't see
how you can put it on the web without the EPA approving of what has happened
here, because this is a joint advisory, not a single-agency advisory, and I
don't know how long that process would take and how much input they would want
in changing whatever has been changed here.
So,
this, to me, is a very complicated issue with the two agencies putting out a
simultaneous advisory, but I want to go
back to a suggestion that the Chair raised, and that was to have more than one
advisory.
It
seems to me when an issue becomes sufficiently complicated in a committee,
somebody always says, well, let's divide the question so we can address each
portion as well as we can. I think the
issue of the children is given very short shrift in the present advisory.
The
statement is, "Follow these same rules when feeding fish and shellfish to
your young child, but the serving sizes should be smaller."
Well, you know, the young child can
vary from 20 pounds to 80 pounds, and we don't have any clarity in terms of
what the serving size is, certainly not what the serving size is for children.
I
think if that were presented as a single free-standing advisory, one could, in
fact, give some very useful information that would be immediately available
rather than having the consumer having to go to another source to look up that
particular information.
DR.
MILLER: Good point.
The
bus to take the people back to Reagan National is waiting and he wants to know
how long.
DR.
DWYER: Could I ask a question, a
procedural question. Isn't all of this
public information?
DR.
MILLER: Oh, yes.
DR.
DWYER: So, it is already all over the
Washington Post and Chicago Tribune, and so forth.
DR.
MILLER: There is nothing secret about
it.
DR.
DWYER: What is the problem about
posting it to the web and than making
better things as time goes on?
DR.
MILLER: No problem. It's a question of time. It's a question of
how long. Before you post things, you
have got to get permission through the hierarchy.
DR.
DWYER: Well, it can't take more than
two years, which is what it has taken.
DR.
MILLER: But, Johanna, that's the issue
right there in a nutshell. It took two
years.
DR.
ALLER: I am going to also try to bring
us back perhaps--again, I keep going back to the fact that we are looking at
targeting at some, what, 8 percent of the population, and that we were provided
a draft advisory and asked to comment on it, and at the risk of something, it
seems to me that where I would like to see us focus on that advisory is we
heard that, in framing that message, that several behavioral do's and don'ts
are appropriate; don't eat this fish, do not consume this.
I
think in my very simplistic view of this, it seems that my advice back to the
agencies would be tinker a big with your three rules. I am not sure you have quite got those rules correct. Do eat this. There may be a group from which you can have one meal, and this
gets to the serving size and the portion, and all of that, but here is
something for which you need to be very, very limited, and here are the fish,
here is a whole list in this case of the do eats.
These
are the ones, again getting back to that low group. I don't know if we are going to come up with that very low group
or not, and I wouldn't worry about it at this particular point in time, because
I do think it is important to get this message out.
I
do think we also need to say to the agencies, you made a stab at tuna, but we
don't think you quite got that right, so let's put light tuna into that lower
group. I am not quite sure I have heard
enough to be convinced where albacore goes, whether it goes in the do not or
into that
once-a-week with whatever portion size.
I
think the other place that we thought the agency didn't quite get it right had
to do with portion size, not only for the adult, but for children. I think that there was a suggestion, and I
think it has a great deal of validity, to take a couple of weights of kids and
say this is what this translates into.
I think that is very useful advice that people can follow.
Those
were the, like, basic messages that I heard. The other thing I heard was in the
delivery of these messages, there may be different ways to deliver that
message, and let's get some more work on that.
But my own sense is, if we structure our conversation next to where do
we think that albacore should be, I would feel more comfortable going back, and
I think we have come up with a pretty good set of, this is your priority, this
is what we feel is the priority for the agencies, and we can give you these wonderful
long laundry lists that we have heard here of lots of other things you can do
spend your money and direct
resources into more information, which
I believe we do still need.
DR.
MILLER: That is very good. I wish I would have thought of it myself.
Suppose
we take that as a start for putting together the recommendations that we talked
about, and we will get it out of the transcripts, so I won't make you write it
down.
DR.
ALLER: Thank you.
Because
of the hour, unless there is something that is vital, really vital, I am going
to thank you all very much for dealing with an extremely complex situation,
thank all the other speakers and the staff people from EPA and FDA for making
excellent presentations.
I
declare this meeting adjourned.
[Whereupon,
at 3:55 p.m., the meeting
concluded.]