ORRHES Meeting Minutes
December 2, 2003
Presentation by Dr. William Taylor
DR. WILLIAM TAYLOR: Good afternoon. Can you hear? Good. The focus of
today’s meeting is primarily on the Y-12 Uranium Releases Public
Health Assessment and you all will be hearing a lot more about that. I’m
going to give you a very brief introduction to conclusion categories of
public health assessments. The reason for this talk is that you have before
you today resolutions to consider on concurring with the conclusions of
the public health assessment, the Y-12 assessment. My talk is more generic
and I want to give you a little background so you understand what that
means, what the conclusions are. And as a little background I will tell
you that when the agency first started doing health assessments in the
1980's there was a lot of variety in those reports and it became very
clear to the staff that worked at that time that they needed to standardize
what they were doing. And as a part of that process quite a few people
got together and put out this text which is Public Health Assessment Guidance
Manual. This was released and final in 1992 and it’s really quite
a remarkable document. It not only takes you through the steps of conducting
a health assessment but also there’s a lot of information to draw
on that helps the health assessors to complete that job. After close to
ten years of using this document the agency staff and others who were
using it realized that there was room for improvement and some updating
and so, in the late 1990's they began updating it and right now there
is a newer version of it that is not yet final. But what is final is that
the agency has adopted the conclusion categories from the revised version
of the guidance manual, and that’s what I’m going to be talking
from today is the newer version; the one that’s in use in the agency.
So, whereas the updated Public Health Assessment Guidance Manual is not
yet final the conclusion categories are. I have about eleven slides. I’m
going to go through some of them very rapidly. I just want to point out
some things to you and I’m going to try to keep this talk fairly
short. I’m going to be talking about conclusions, recommendations,
and the public health action plan, but I’m generally going to concentrate
on conclusions. Oh, you have a handout in front of you with most of my
slides on it by the way, and you can follow along. There’s one that’s
out of order from the selection but it’s the set with the lines
on it if you want to take notes. That’s just the way it was printed.
Public health assessment conclusions are intended to characterize the
degree of public health hazard at a site based on these three principle
bullets here. The existence of past, current, or potential future exposures
to site-specific contaminants including radionuclides or physical or safety
hazards. Secondly, the susceptibility of the potentially exposed population;
and finally, the likelihood of exposures resulting in adverse health effects.
That’s what the conclusions are about. There are three conclusions
and five conclusion categories. Basically, the conclusions are that the
conditions pose a hazard, do not pose a hazard, or pose an unknown hazard.
The five conclusion categories are listed here.
DR. HERMAN CEMBER: Where it says: pose an unknown hazard. Does that mean
that there is a hazard but you don’t know what it is or is it that
you don’t know whether or not a hazard exists?
DR. TAYLOR: It means that we do not know whether a hazard exists. Good
question, thanks. The five conclusion categories are as listed. You can
read them. Urgent, public health hazard, public health hazard indeterminate,
no apparent, and no public health hazard. Now, when I write conditions
up here at the top I might be referring to a particular contaminant of
concern, a particular pathway such as breathing air or drinking water.
I may be referring to the site as a whole or I may be referring to past,
present, or future exposures. The specific meaning is framed by the particular
public health assessment and we usually, sometimes there are different
choices that we can make as public health assessors. We pick a frame work
that works best for the particular instance that we’re talking about
and Jack and Paul will tell you more about the frame work for the Y-12
public health assessment. So, conditions can have different meanings depending
on the specific document. This is an overhead right out of the guidance
manual and it shows you the relationship between three conclusions and
five categories. And this is a graphic way of presenting it. The Categories
1 and 2 fall under the hazard and Categories 4 and 5 under no hazard.
I think it’s pretty obvious. I think the point I’m making
here is that the public health assessor does not make up the language
for the conclusion. The language is selected out of the guidance manual
and we use those terms and those categories. This is the menu that we
choose from when we make our decision.
MR. WASHINGTON: What’s the difference between no apparent public
health hazard and no public health hazard?
DR. TAYLOR: That’s a good question. My next slide is on the definitions
of the categories so I will address that. You may not have this in your
handouts. Ok, you’ve got it, good. ‘No apparent’ applies
to sites where exposure might have occurred in the past or is still occurring
but the exposures are not at levels likely to cause adverse health effects.
With ‘no public health hazard’ Category 5 applies to sites
where no exposure exists. So, with number four exposures may have or probably
do exists, but the levels of exposure are not likely to cause adverse
health effects. And in number five no exposures as best as we can tell.
The difference between Categories 1 and 2 is a difference between timing.
Number 1, urgent public health hazard, applies to sites that have certain
public physical hazards or evidence of short-term, less than one year
site- related exposures, which could result in adverse health effects
and require quick intervention to stop people from being exposed. With
our second category, public health hazard, applies to sites that have
certain physical hazards or evidence of chronic more than one year site-related
exposures that could result in adverse health effects. And finally, the
indeterminate public health hazard is where critical information is lacking,
missing, or have not yet been gathered to support a judgment. So, this
is the menu and these are the definitions that we’re working from
and this will be the foundation for our discussions later today when we
talk about the Y-12 Uranium releases. What does it mean to select a category?
This is wording I’ve taken out of the guidance manual: It means
to arrive at an answer to the question based on available exposure data,
toxicological data, epidemiologic data, medical data, and site-specific
health outcome data. Are adverse health effects expected in the community
including impacts to any uniquely vulnerable populations. For example,
children and the elderly in the community.
MR. LEWIS: I guess you’ve got a listing of all sorts of data there.
Are we expected to have an evaluation of all quote available date in those
areas if it is considered legitimate or validated prior to selecting a
category?
DR. TAYLOR: Yes.
MR. BOB CRAIG: James said ‘are we to’, and in fact we are
not to, ATSDR is. We advise ATSDR but they make the conclusion.
DR. TAYLOR: That’s true. The health assessor and the agency that
puts out the document, that is us.
MR. LEWIS: And if for any reason they don’t utilize some of that
should we expect an explanation that’s laid out in the body of the
document that clarifies why that is not being used or what the expectations
are around that issue?
DR. TAYLOR: I think the answer is not necessarily. It’s up to the
health assessor to do that evaluation and determine what data are pertinent.
MR. WASHINGTON: Do you really have a lot of data for the toxicological
data on the various contaminants?
DR. TAYLOR: I think it varies quite a bit. We usually have some and over
the period of years, the last few decades, we’ve accumulated quite
a lot for different contaminants. This is not only at a single site. This
would be animal studies and human studies when those studies are available.
MR. WASHINGTON: What about the combination of the contaminants?
DR. TAYLOR: That’s a difficult issue, but it’s one that’s
been taken up by the EPA, as well as other organizations for, I would
say, a good ten years and there’s research going on in that area.
So, there is some information that’s available.
MR. WASHINGTON: Of those that are listed, which one would you say is
most credible?
DR. TAYLOR: Credible in what sense?
MR. WASHINGTON: Which one has the most reliability and therefore validity?
DR. TAYLOR: Well, the data are, let me hold that question please and
I think I’ll answer it or attempt to address it in a moment, and
if I don’t let me know. Yes?
MS. BARBARA SONNENBURG: How would you define health outcome data? Give
examples.
DR. TAYLOR: These are, for example, cancer incidents data are health
outcome data. These are the data that the state is collecting and is in
a registry. Those are public data or data on populations that are available
about people’s health.
MS. SONNENBURG: How about children and maybe some kind of educational
defects? Would that be health outcome data?
DR. TAYLOR: If it’s available.
MS. SONNENBURG: And if it can be compared?
MR. TAYLOR: Yes. So, for example, somebody’s private medical records
are not health outcome data for our purposes because we don’t have
access to that. But if it’s collected in a manner that we can examine
then it’s health outcome data. CDC, for example, keeps databases
on mortality all around the country, all across the country. So, those
are health outcome data as well. If there are particular health studies
that look at the health of a particular community those might be available;
those could be health outcome data.
MR. WASHINGTON: What about the uncorroborated data we got on iodine when
we had a meeting some five or six months ago? There were about four or
five individuals who came to that meeting and said that they had had that
problem and they at least said to us that there were more people in Oak
Ridge that had a similar problem?
DR. TAYLOR: I would say the health assessors take into account anecdotal
data, which is how I would describe what you’re saying, and there’s
not any particular kind of analysis we can do with that, but it’s
taken into consideration.
MR. WASHINGTON: But we didn’t do a follow up, right, with those
individuals?
DR. TAYLOR: I’m not aware of what we did.
MR. WASHINGTON: Does anybody else remember that? What we did at that
meeting? Does anybody else remember the meeting where we had about four
or five different individuals who at the time when we were discussing
the iodine data came to us and said that many of their classmate had had
problems? Did we ever do a follow up on that? Does anybody else on the
Board remember that?
MS. PEGGY ADKINS: I remember one person in particular coming and saying
that at Kingston the Kinser Drug or Kingston Drug had a very unusual amount
of thyroid medication that they issued every month that it was totally
out of balance with what other drug stores they compared themselves to
administer.
MR. JACK HANLEY: Those concerns were likely to have been captured, and
we can validate that, but I’m sure they were captured into the community
concerns of database we have. And if it’s an iodine or thyroid issue
in discussion that will likely be discussed in the iodine public health
assessment and we would hold off that discussion until we get to the iodine
where that becomes, where thyroid becomes an issue.
DR. DAVIDSON: I have a question on the relationship of the health outcome
data and I guess in the other data too, when it comes to categories in
which there’s no exposure. So, if the health outcome data is this
data related to the particular contaminant that’s being studied
or is this just kind of a general thing? For instance, cancer outcome
data would not be related to chemicals that are not carcinogens that have
not shown to be carcinogens in either human or animal studies? Would that
type of data be discussed for those particular contaminants or would you
focus on it for contaminants in which you have said there’s no exposure?
Because if there’s no exposure then there shouldn’t be any
health outcome related to that particular contaminant.
DR. TAYLOR: I have a couple answers to that. One is that it might depend
in part on how strong the exposure assessment is. If our data for our
exposure assessment is very strong there may be little need for a discussion
of health outcome data. If the exposure assessment indicates that there
were not exposures at levels of health concern. On the other the hand,
health outcome data still could be included and still could be discussed
if there is a strong enough interest in that based on concerns in the
community. So, all of these things have to be considered by the team in
Atlanta by the health assessors in deciding what’s appropriate to
have in the document.
MR. DON BOX: I have a question on Category 3 here that you might clarify
for me. In our lives everything seems to be tightening down more and more
all the time. If you have a Category 3 and it’s judged as really
not a hazard and then new regs come out making it a hazard, do you grandfather
this Category 3 or do you go back and reassess everything on it? Category
4, actually.
DR. TAYLOR: Category 4?
MR. BOX: Yes. Where it says–
DR. TAYLOR: We do not re-evaluate our public health assessments unless
there is significant and compelling reason to do that, and it may be because
new toxicological data appear that are overwhelming and suggest to us
that we were not safe enough or we were overly protective. But it depends
on the quality of the information that become available and not regulations.
DR. CEMBER: I have a comment with regard to the items for which there’s
no exposure but a possible health outcome. If people are concerned and
they’re worried about it, we know, everybody knows, all the scientists
and I think most people know there’s a strong relationship between
body and mind. And if people are fearful about it and we do know there’s
real data that show it influences the immune system, for example. So,
if people are concerned about the possibility, if some rumor spreads around
that there’s contaminant A in there and there really isn’t
any or at least you haven’t been able to find it but people are
very much concerned about it, this might lead to some mental effects.
Does the agency consider mental effects as a medical outcome or a health
outcome?
DR. TAYLOR: I don’t know the answer to that. I think, I’m
not aware that that has occurred although it might have. One problem may
be that mental effects are something that aren’t collected in databases
as much.
DR. CEMBER: The mental attitude of the concern have physiological effects;
that’s what I was thinking of, and there is a relationship.
DR. PAUL CHARP: In response to Dr. Cember’s question, in some of
the assessments I have done on radiological issues where the category
was Category 1, an urgent public health concern, we’ve taken into
account the psychological effects that people have being exposed to high
levels of radiation. So, that’s not the direct answer to your question
but we have evaluated that and I’ve told people that they should
either see a physician or be evaluated for some type of psychiatric or
whatever. So, it has been thought about for the radiation sites and there
has actually been quite a few discussions within CDC and ATSDR dealing
with weapons of mass destruction; the psychological impacts.
DR. TAYLOR: Are there more questions here?
MR. WASHINGTON: You said that you had told some people if they thought
they had some problem with this that they ought to see, what did you say,
a psychiatrist?
DR. CHARP: Well, they should seek medical help. We can’t tell people
they need to go see a psychiatrist.
MR. WASHINGTON: And this is actually in the database, the statements
that you’re making are really a part of–
DR. CHARP: They will be somewhere within the ATSDR record of activity
for that site. It wouldn’t necessarily be for Oak Ridge but we’ve
had five sites across the country that were contaminated with radioactive
material that we considered sufficient hazard where we told EPA put these
on the national priority list, and that’s the ones they’ve
been evaluated for.
MS. KAPLAN: I don’t think that exactly addressed the question that
Herman asked though because, no, it did not. Because he was commenting
about the psychological impact on the physical body that results in tangible
physical problems, not to go see a shrink because you’re crazy.
You know, that was kind of the implication I got there but he’s
talking about actual physical effects because your immune system goes
down because you’re worried all the time.
DR. CHARP: Well, I know, and I skirted the issue and I said this didn’t
answer his question exactly but it was, I knew the question he was asking
and, have we ever evaluated that way, no. But we have suggested people
go seek medical help if they need it.
DR. TAYLOR: Probably the answer is no we’ve not looked at physical
effects as a result of stress or concerns and fear.
MS. ADKINS: Since this has been brought up I just want to clarify for
the record that in the fifties and sixties it was just the opposite; everyone
was assured unquestionably that there was no harm, that everything was
safe, and everybody felt that everything was safe and that it was a joke
to think otherwise. That was until they died from cancer and all these
other diseases. So, I want to counteract, I just want that to be on the
record that scientists would come to the classrooms and in just general
conversation it was laughable that there was any possibility that there
was harm from the plants.
MR. LEWIS: I want to get back to the statement I heard Kowetha made and
correct me if I’m wrong. Kowetha indicated if there was no exposure,
you know whether or not you would have to use the health outcome data
as a part of your evaluation. I listened to that very closely because
I guess when we get to the place there has been some exposure, whether
it’s enough to create a hazard is something different. But along
with what Herman is saying, we’re talking about the community at
large. The community at large has a quote perception, they lack the same
technical knowledge that some of the experts in this room have, and they
have a deep-seated feeling which was brought out via a good assessment
of what the community’s concerns were which is what we did not have,
which indicated that cancer was the number one issue. And as a part of
that effort I’m sort of silly enough to always read not only your
current manual but your old manual, and when I compare those two when
you go like from one rev to another you always compare the sections to
see what happens. A lot of times you can de-emphasize something. You go
from over here where you have a category that says you will address health
outcome data. You come over here and it’s a little vague. But if
you read deep enough into the body of the text it says there shall be
a discussion in that area. I guess the point I’m getting at is that
because cancer was such a high item and if it falls under the area of
quote health outcome data, is it standard practice when you get information
of this nature that that is always taken into account and evaluated as
it relates to the health of the, the mental health of the public who is
very concerned about something over thirty or forty years. Do you weigh
that in as part of the evidence that determines whether or not to address
that as a part of your health assessment?
DR. TAYLOR: I think the answer is yes. I want to return to that issue
and Mr. Washington’s question and some comments that various people
have raised in this overhead. I’m not going to read these. The title
here is what factor influence the selection of a conclusion category and
you see here at the bottom, I’m going to move this up so you can
see it. Community health concern and community specific health outcome
data are part of that, and what I want to say to you again is that the
health assessor has to determine where is the most compelling information
and we call it a weight of evidence approach in the new guidance manual
and it’s a subjective professional opinion. So, there’s not
one answer for every public health assessment. The data have to be looked
at for how good they are and how adequate they are, data of all different
kinds. So, I hope that helps you understand. Many times, I would say most
of the time, the conclusion falls out pretty easily, usually from the
exposure assessment and evaluation. Sometimes it’s not so clear
but the health assessor is compelled by the guidance manual and the way
we’ve been doing things over the course of the agency to take into
consideration all of the available information.
DR. CEMBER: I don’t see in there a category on the magnitude of
the exposure. We talked about the exposures there, potential and actual,
but I’m sure you do consider the magnitude of the exposure, but
it’s not listed explicitly in there.
DR. TAYLOR: Yeah, when I hear the term exposure assessment myself I think
it actually can mean a couple of things. It can mean a pathways assessment
of whether or not there were exposures. And secondly, if there were exposures,
what were the magnitudes and what are the health implications of those.
So, you look at the exposures and ATSDR puts its exposures in terms of
doses. So, that’s our unit of measure of exposure that we evaluate
and then we look at the toxicological information and what health information
is available. So, that is part of the work. Alright, I’m going to
switch now and tell you very quickly about recommendations. I’m
going to keep this fairly general because again they’re going to
be, they could be vastly different from one public health assessment and
from one site to another. So, recommendations are made to identify practical
ways to stop, reduce, or prevent exposure; activities to further characterize
the site and possible exposure; and health activities that are service
or research oriented, such as medical monitoring, health education, health
studies, health surveillance, or a substance specific research. Those
are wide categories so it means the recommendations can cover a lot of
territory. And in the next slide I have some examples of these and I’m
not going to read them all except to point out again that the headings
are: actions to cease or reduce exposures; actions for site characterization;
and at the bottom here health activities, which may include education
or conducting other types of research. Now, there are many more examples
and I didn’t bring lists of those for you. I just wanted to touch
on the fact that recommendations can cover a wide variety of issues. Next,
I want to tell you what a public health action plan is. It’s a part
of the public health assessment, and this is wording I took right out
of the guidance manual. Public health assessment must include a plan that
clearly describes the implementation and timing of recommended public
health actions. Public health action plans outline actions or activities
that have already been taken to protect public health, activities that
are currently under way, and activities that will be conducted in the
future. And the footnote reads: If the site poses no public health hazard
that is conclusion Category Number 5 a public health action plan may not
be necessary. Now, what this all says is that it’s a way of framing
the recommendations. It’s an elaboration. It’s a little bit
more than just sticking recommendations with no explanation; it’s
a little bit of background and it specifies the timing of any intended
activities. The recommendations can be made to different organizations
and agencies. They may go to EPA, for example, and they may be for other
parts of ATSDR or other local health authorities.
MR. WASHINGTON: It was brought to our attention some time ago that at
one time during the distant past near K-25 there was a very viable community
there, two or three hundred people. And that community no longer exists,
but we had some people come to the committee and tell us that various
people died of all kinds of illnesses. Would that be instructive to include
in this study? Could we look for some of those people who lived in that
community? Would that shed some light on what we are doing or would it
just confuse the issue?
DR. TAYLOR: It may be important. We have a separate public health assessment
for the K-25 releases and the communities that were impacted by those
releases will be looked at separately from the public health assessment
for the Y-12 Uranium releases. That’s part of the work that’s
coming. This is my last slide. I’ve listed some possible factors
to consider when developing the recommendations and the public health
action plan. You have these in front of you and I won’t read them
to you. It’s just a variety of issues that we, as public health
assessors, take into consideration. That’s all I have. Are there
any more questions? Mr. Lewis?
MR. LEWIS: I have a comment. I’d like to thank you for a presentation
that, in my opinion, is very late. I really feel that I sort of pushed
to have this done. The whole concept of what’s captured in this
guidance manual I think would be beneficial to us if we had a good preview
of what they do and how they do it. I’ve taken time to try to read
these things and study it. I hope this has been helpful. I would like
to see us look at having some real presentation given to us so that we’ll
all be aware of what we’re trying to do or at least what we’re
looking at. I think it would be helpful to the community and to the subcommittee.
I hope that could be taken into consideration at a later date.
DR. DAVIDSON: Thanks, Bill.
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