RESIDUE CONTROL IN A HACCP ENVIRONMENT

SUBCOMMITTEE 3

Pages: 1 through 57

Place: Washington, D.C.

Date: October 31, 2000

THE UNITED STATES DEPARTMENT OF AGRICULTURE

RESIDUE CONTROL IN A HACCP ENVIRONMENT

SUBCOMMITTEE 3

Lafayette Room

Loews L\'Enfant Plaza Hotel

480 L\'Enfant Plaza, S.W.

Washington, D.C. 20024

Tuesday,

October 31, 2000

The meeting on the above-entitled matter was

convened at 7:20 p.m.

APPEARANCES:

[CHAIRPERSON]{.underline}

MS. CAROL TUCKER FOREMAN

[MEMBERS]{.underline}

MR. MAGDI ABADIR

MS. CHERYL HALL

MR. LEE JAN

MS. ROSEMARY MUCKLOW

MS. DONNA RICHARDSON

MS. PATRICIA STOLFA

[P R O C E E D I N G S]{.underline}

(7:20 p.m.)

MR. ABADIR: To start this process, we need to narrow it down so that you
have an objective that can be met beforetime. That means chemicals that
we know that they have public health \-- number one, and that we know
that we can sample them and test them. Those are the objective \-- .
This is the first group to start the program so that we see the results
and then people can see results and say, hey, let\'s put more money for
research here, for the other chemicals, whatever. But to start too wide,
you\'re not going to go anywhere. It\'s too wide of an objective.

One of the interesting things here that people can start with, as I
said, is the methods \-- are the methods developed to be done. And this
is the first line of \-- that we want to be looking at specifically, so
just putting this in a comment \--

MS. STOLFA: Yes. Well, and I think that when the Academy recommends
bringing \-- having a process that integrates the concept of risk
assessment, that that\'s one of the things that they\'re talking about.
And you know, there are real issues to be thought about as to how we
might do that. Now, we have in tried in recent years to make the
selection of compounds that are in our annual testing plan more
public-health risk based.

It\'s not clear to me that anybody knows that or that anybody agrees
with the criteria we use, that people don\'t have some other ideas as to
what should be the criteria. But I think that\'s part of what centers
around the recommendation regarding incorporating risk assessment.

MS. FOREMAN: Does FSIS do the risk assessment? The tolerances are set
elsewhere, so \--

MS. STOLFA: FSIS has a group. And it doesn\'t \-- it\'s one of the
interagency groups that makes the annual testing plan. And that\'s the
group that \-- and that activity in recent years \-- you know, they tell
me, oh, we\'re risk based now. And I say, yeah, well, nobody can
understand it.

And so, you know, how can anybody have confidence that it is truly risk
based if they can\'t understand what you do. So there\'s probably room
for transparency. There\'s probably room for consideration of whether or
not people really think it\'s risk based.

All the people, which includes some people from FDA and, I think, CDC
who design that plan each year, think that they\'ve made progress and
\-- but other people might have different views on that or might have
better ideas about how \--

MS. FOREMAN: But as Magdi asked, is there someplace that I can go and
find a risk assessment that says we \-- we\'re spending our resources to
manage these risks because we know that these chemicals are very likely
to occur and likely to cause harm or are less likely to occur because
fatal harm \-- you know, the typical risk assessment? Is there someplace
where there is a risk \--

MS. STOLFA: The blue book.

MS. FOREMAN: The blue book.

MS. STOLFA: The blue book has a description of that process which its
designers characterize as being more risk based. We can certainly have
somebody explain exactly what they do. I mean, but it is in the blue
book.

MS. FOREMAN: Okay.

MS. STOLFA: And the most current version of the blue book would have a
little section on how they do that. I, myself, don\'t find it to be
transparent. But I don\'t have an extensive technical background, so,
you know \--

MS. FOREMAN: Is it a formal risk assessment?

MS. STOLFA: No. It\'s a ranking system that considers several factors.
And it\'s different from what we used to do. So that\'s, you know,
that\'s a \-- I think that\'s a topic area.

MS. FOREMAN: So the \-- one of the things that we need to look at is
having a ranking system that is logical and transparent.

MS. STOLFA: And risk based, according to the Academy.

MS. FOREMAN: Yes, and obviously risk based. Put the resources where
they\'re from.

MS. STOLFA: Yes. I mean, I think that\'s important to discuss. As I say,
I think sampling is an interesting and provocative topic. If the right
people come to the meeting, I think methods development is potentially
an interesting topic. Clearly, it\'s expensive. It takes a long time.

However, other parts of the world have developed live animal methods and
used them more than we do. And I believe that the technical capability
is not particularly retarded in the U.S. I don\'t think that anybody
knows there might be a good market there, or that has not been added to
what we convey.

So I think there is a methods development issue to be explored. We
can\'t have methods that nobody but us and FDA can figure out how to do.
We can\'t have methods that are so expensive that nobody else wants to
do them. And we\'re not going to have methods tomorrow. We have to
accept that it takes time to develop methods. And so, I mean, that\'s
another thing that we \--

MS. FOREMAN: Why don\'t we do this very informally? Let\'s \-- don\'t
look, let\'s just ask, just get into a discussion.

MS. HALL: Okay. I don\'t want to get off that subject that you\'re
currently on, but I want to go back to the logical, transparent system
of testing, to be sure that we address the risk by category of animal,
too. There are some things that I think you have to test for in all
categories, that are so dangerous, you know, that you don\'t want them
in anything. But there are certain categories, as Pat suggested, that
have continuous problems. And those probably need to be monitored a
little more closely \--

MS. FOREMAN: Thank you.

MS. HALL: \-- for that reason, for the history.

MS. MUCKLOW: Carol, having spent a lot of time working with my friend,
Mark Dopp (phonetic), here, I\'d like to ask if Mark may come and sit at
the table with us because we have done the efforts we\'ve done for the
last year in partnership together. We\'ve held many meetings on the
subject of residues and how to go from where we\'ve been to where maybe
we need to be going for the future. And we don\'t always agree. But he
brings a different perspective to this issue. And so I would ask that
the committee allow him to come and sit at the table with us and
participate as a live participant in this process.

Secondly, I think we have to recognize that the Agency in its
traditional inspection role accepted responsibility for testing
livestock that comes into the food supply that may be carrying violative
residues, because that particular act, the selling of an animal into the
food supply for food if it contains violative residues, is a violation
of the law that isn\'t under the authority of the Food Safety Inspection
Service.

It\'s the violation of the Food, Drug and Cosmetic Act, FDCA. And a
meatpacker or a poultry processor is simply that narrow space in the
funnel of the distribution system where it is very convenient to test
for this and get the best results in a distribution system to find out
whether that \-- whether those livestock are free or not free.

I think you need to give a lot of respect to the past practices of this
Agency as it has struggled with this issue, whether we\'ve gone from the
fast test to the stop test to whatever test it is, the rapid tests, and
thereafter the confirmation tests. So I think that any discussion of
this issue without a good background of the fact that a lot has been
done and there is a lot of success to talk about in terms of making the
meat food supply different \-- the challenge we are faced with now and
the challenge, as I understand it, of this meeting is how to take it
from that traditional role where the government has taken that
responsibility and convert it into a HACCP system where it is a
company\'s responsibility when they have all the testing equipment and
knowledge. And again, it\'s still a violation of FDCA, bringing that
animal in. And to what extent does the packer accept some of that
testing responsibility?

There are some firms out there, some meatpackers who have taken much
more responsibility for one reason or another in looking at the
livestock that are coming through their door, having certifications,
doing the followup with producers when they have a violative animal, and
working with the Agency to make sure that they go back to that producer
to see what education and corrective action he can take to make sure
that he quits doing whatever it was that allowed an animal with a
violation of a drug to enter the food supply.

In addition, we\'re trying to figure out, does the packer take absolute
responsibility for this? Do we say, goodbye, FSIS lab, the packer\'s now
going to be responsible? I don\'t think that anybody\'s going to be
comfortable with that. I think there is a role for the government
testing scheme to work for the industry. I don\'t know the answers to
that. But I think that\'s what we are here to talk about. And I think
there\'s a tremendous success story about what the government has done.
We are a hell of a lot better off in the year 2000 than we were in 1985.
And that\'s because a lot of energy and initiative has been put into
this process. But as I told you all today about phenylbutazone, here is
a drug that is not supposed to be given to a food-producing animal. If a
veterinarian gives it to an \-- gives it to a producer to give to a
food-producing animal, that animal should wear a special mark for the
rest of its life because neither its milk nor its meat ought to enter
the food supply. And that\'s a violation of FDCA. It\'s not a violation
of the Federal Meat Inspection Act.

MS. FOREMAN: Rosemary, I understand \-- I can understand your concern
and where you think we are supposed to go in this meeting. And if the
group decides we will go there, then it will be over my objection. But
we can go there. We have been asked to respond to \-- or to deal with
six specific questions that, instead of being oriented to the past and
the concerns of producers, are at least in five of those questions
oriented to looking to the future and how the Department can design a
system that addresses \-- that is open and transparent and creates the
greatest amount of public understanding.

I understand that in the public meeting the issues that you\'re talking
about have to be addressed. I think I\'d leave it to the subcommittee. I
would at least ask that we spend part of our time this evening
addressing the questions that we\'ve been asked to address.

MS. HALL: Do other parts of the industry have the same memorandum of
understanding about testing that some poultry companies have, where
they, you know \--

MS. STOLFA: That\'s \-- the poultry industry, as I recall, decided a
number of years ago that it didn\'t want to have any residues. And
because of its organization and its integral \-- that it\'s integrated
\-- its vertical integration, it was able to say, hey, we\'re not going
to have this problem because we don\'t need it, and took certain steps
including their own controls and their own testing programs in certain
cases. I remember when some stuff was going on in Virginia with a
laboratory that was just developing there, that was going to test \--
oh, I think they were going to test both feed and there was probably
some tissue testing also. That was particularly facilitated by the
organization of the poultry industry.

No, other people don\'t do the same things.

MS. FOREMAN: But let me understand. The poultry industry has in fact
instituted a HACCP system for \--

MS. MUCKLOW: No. Larger companies have a system where they test every
house that processes, about ten days before it processes. They take
tissue samples, kidneys and fat, and test for compounds, pesticides,
PCBs, antibiotics, everything. So those birds have to pass the test
before they\'re allowed to process.

MS. FOREMAN: Is that \-- but it\'s only the larger companies that do
that?

MS. MUCKLOW: That\'s my understanding. You see, you\'ve got to support
quite a bit of equipment.

MS. FOREMAN: Is it some MOU with \--

MS. MUCKLOW: With the government. The

government \--

MS. FOREMAN: \-- between those companies and the government?

MS. MUCKLOW: Yes. And the government still does random sampling in the
plants. That\'s not changed. But this is just a way to avoid residues
for integrated companies.

MS. FOREMAN: As \-- supposed to be with young animals, wouldn\'t it? You
wouldn\'t want to spend \--

MS. MUCKLOW: Yes. And we\'re talking about a lot of equipment and
personnel to run these tests. So smaller poultry companies \-- I mean,
they couldn\'t support that lab.

MS. STOLFA: There may be cooperative labs some places. I don\'t know.
But I do know that the practice \-- it\'s been a long time since we\'ve
had residue problems with poultry, and they tend to be true, unforeseen
hazards like the stuff that was in the clay.

And I think also that you need to \-- we have some slightly different
methods that we apply in situations where a flock is considered to be
uniformly raised. And so we do composite residue sampling for poultry.
You know, there are little things, and we can put a bunch of them
together, and then only if you have a result that\'s \-- that indicates
problems, do you go back to \-- I guess there\'s some potential for that
eventually in the swine industry, and we may do some things that we now
\--

MR. JAN: It could be done in feedlot situations.

MS. STOLFA: It could be done in feedlots. It certainly could.

MR. JAN: And in fact, now in FSIS\'s residue program, if there\'s a
violator \-- or they used to at least have the option of, if they\'re
sending a bunch in, send, like, five or so out of a lot. If they\'re all
the same, get those tested. If they\'re cleared, then they can do the
rest without testing. But I\'d like to just say one thing here, that the
topic here or our title of our discussion should be residue control in a
HACCP environment.

And I don\'t see how these six questions really relate to that directly.
I know they relate to a meeting that\'s coming up that\'s supposed to
address that. But I would like to say that with FSIS\'s past performance
in testing and the residue-control programs, that the residue problem is
very low.

We\'ve got very low incidence. So that means that if we are going to use
testing to control it further, we\'re going to have to do those three
thousand samples. So I think we need to look at HACCP and let\'s apply
HACCP principles. And those things need to be somehow moved down to the
producer and not \-- you can\'t ask the packer, just as you can\'t ask
FSIS or the taxpayer, to fund all these tests for all these things that
could happen.

I think we are at a point where the testing is throwing good money \-- I
mean, just to test everything at the high level that we have to do is
really throwing a lot of money. So I think we need to look about
recommending that HACCP principles are applied down the chain \-- or up
the chain, I guess. That would be upstream to some kind of control.

Now, that could be done with some \-- it would be easier to be done in,
like, the chicken things where you have them all \-- big operations. You
can do it in the larger swine operations and the feedlots. But there are
a lot of livestock and a lot of swine, and I don\'t think so many
chickens, maybe some turkeys, that are produced by small producers. And
they need I think to have some way \-- and I am not in favor of more
regulation. But maybe it\'s time to look at regulation outside of FSIS
and in another USDA agency.

And one would be to take these drugs away from the feed stores that
every small producer \-- and he has the right by law to treat his own
animals. And I think a new philosophy has to be looked at. These animals
that are going to be food are not their animals. They are only the
caretakers, and they are food.

And so to say they can practice veterinary medicine where they have no
training, just because they saw grandpa use something in a white \-- or
gave a shot and it made things better, now they\'re \-- we need to look
at somebody having \-- that is responsible, a veterinarian if it\'s a
drug for treating an animal, where he\'s got the training or he or she
has the training, the knowledge, the expertise. They know how to use the
drugs, they know the deals and they have a license that they stand to
lose if they abuse that. Where a farmer just can go down to a feed store
and get what he wants.

And I know when I was in practice, there was a feed store operator that
would tell the farmers that he was the next best thing to a veterinarian
because he applied for vet school. He didn\'t get accepted, but he
applied for vet school. And so he said that he was nearly as good as a
veterinarian. So he was prescribing, diagnosing, all those kind of
things illegally.

I don\'t know how much that goes on. Another example is, we had a client
that had a sick animal called out to have a look at. And I don\'t
remember now whether it was pneumonia or coughing or whatever it was.
And we asked him, you know, did you give it anything, you know, so we\'d
come prepared what to go for. He said, well, yeah, I gave it 30 cc of
regular vaccine. Well, so why did you do that? Well, that\'s all I had.

So if you have that kind of small \-- and you make all that available
through the feed stores, then you\'re really not going to get there. So
I think that maybe this committee \-- or it ought to go to Dan Glickman
and down to some of the other agencies, because I think USDA regulates
all the animal drugs.

MS. FOREMAN: No. FDA does.

MR. JAN: No, no, FDA does human drugs. USDA does \--

MS. FOREMAN: The Center for Veterinary Medicine.

MR. JAN: Oh, the Center for Veterinary Medicine. That\'s right. That\'s
right.

MS. FOREMAN: As a matter of fact, I think you\'ve come up with something
important. And I would ask if perhaps we could start by saying that we
clearly need some sort of coherent system for handling a process that
has grown like Topsy. And perhaps the President\'s Food Safety Council
might address this.

They want to get into residues, I believe, and come up with a
rationalized system so that you don\'t have this where FSIS \-- you
know, somebody else sets the tolerance. FDA sets tolerance. CVM approves
the drugs. FSIS checks for them, but FDA has to go on the farm if you
find the violation. FSIS has no authority to go back on the farm to get
it, and it\'s \-- you know, and APHIS has some responsibility for animal
health. So you\'ve got all these agencies crossing over. If FDA goes on
somebody\'s property, it is to investigate a violation and a criminal
action is possible. So nobody wants FDA out there.

So is there any disagreement that we might suggest that a first step in
this process would be for the \-- all the involved agencies, the two
departments \-- I think EPA is involved here as well, isn\'t it?

MS. HALL: I think what we are talking about, sorry, is that the control
of veterinary medicine should be in the hands of the veterinarian. And
that\'s kind of what we\'re asking for.

MS. FOREMAN: Well, I was going to take it back one step and say \-- I
mean, that would clearly be one of them \-- but that you have some
issues here that can\'t be addressed by FSIS, as Rosemary has pointed
out and Lee has pointed out, that we perhaps want to look at the
President\'s Food Safety Council or even, maybe, have the National
Academy of Sciences make some recommendations about how you rationalize
the responsibilities in a process that has never been rational. Has
anybody got problems with starting there?

MS. MUCKLOW: No, I haven\'t a problem with that. I\'d like my esteemed
friend to tell you about the request that he drafted, and I agreed and
signed on to the letter, to FSIS that we are still waiting for an answer
on about how we deal \-- the sample number. Do you want to tell us about
that?

MS. FOREMAN: Wait a minute, is this about sampling? Is this \--

MS. MUCKLOW: No, this is about finding violative residues.

MS. FOREMAN: Could we \-- just before we go there, could we address
under this general rubric here? We need to have some improved control
over veterinary drugs. The MOU arrangement that the large poultry
companies have might be one model to be examined. And now we could go
\--

MS. MUCKLOW: And an interagency model needs to be developed probably for
the large animals.

MS. RICHARDSON: And they do have \-- well, at least when I was at Labor,
there was an interagency agreement between Labor, HHS and EPA on
pesticides, because when I was looking at grapefruits and oranges, OSHA
did part of it. EPA did the other part. And HHS was involved. So I mean,
there is a model. And with blood-borne diseases, they also have an
interagency consult and regs.

MS. FOREMAN: One of the glories of the President\'s Food Safety Council
is that it is one level higher than interagency groups which sometimes
\-- and this is one of those times \-- where each agency sits on its
jurisdiction and basically doesn\'t move.

MS. RICHARDSON: Or if it\'s something they don\'t want to do, everybody
keeps \--

MS. FOREMAN: Well, that\'s probably more common. Everybody bounces it
around.

MS. STOLFA: We have a rather longstanding MOU that includes all of the
agencies that have some jurisdiction.

MS. FOREMAN: But nobody wants to spend any

money \--

MS. STOLFA: Well, some people \--

MS. FOREMAN: \-- or give up any legislative \--

MS. STOLFA: Well, nobody \-- there have been no legislative changes as a
result of the MOU. You can be sure of that. We are generally thought of
as the enforcement arm or, you know, in more common terms, verification
arm. See, FDA doesn\'t have really independent authority that they apply
to livestock which is brought to slaughter. We do that.

MS. MUCKLOW: But they go back to the producer.

MS. STOLFA: Oh, absolutely. And that is how we get our repeat violator
list. They verify it.

MS. MUCKLOW: And they prosecute.

MS. FOREMAN: Which means everybody views them as the enemy and the cop.
So it\'s \-- that\'s why I think until we find some \--

MS. HALL: There has to be an admitted cop. I mean, somebody has to be
there.

MS. FOREMAN: Yes, but \--

MR. JAN: The thing about the cop situation, if you rely on that alone,
how many of us speed every day because of the benefits that we perceive
on speeding and the risk of getting caught and then the penalty you pay
for getting caught is, well, I don\'t like to pay for it. I \-- got away
from it.

So if you don\'t move it to a more proactive thing rather than to just a
reaction to getting caught \-- I think we need to try to somehow get
this focus on the proactive. And part of \-- and we\'ve got \-- FSIS now
has a food-animal production deal, that new area, and we\'ve got APHIS
and all these that we can \-- we could try to get it. And there are
programs out there that are voluntary programs that if we \-- that need
to get addressed, these issues, to get them in a HACCP mode.

MS. MUCKLOW: Well, Lee, this is the \--

MS. FOREMAN: Would it be reasonable to say that the large grower
producers have developed a model that\'s acted on through an MOU?
Perhaps we could have some efforts to establish models for
HACCP/proactive action that are more appropriate for smaller producers?

MR. JAN: There is a little difference, I think \-- and I may be wrong,
but I think the broader people, they\'re integrated. So they kind of own
the poultry from start to finish. Cattle producers that go to a feedlot,
they don\'t slaughter, so they can slip that over here.

They don\'t have quite the same incentive. And they want to \-- they
want to produce a uniform-sized animal to their slaughter facility that
will purchase it at the slaughter facility. And if it takes drugs to do
that and if they can use it \-- and they \-- and I know that they can
find drugs that we can\'t test for, or they know that FSIS can\'t afford
to test for, or isn\'t testing for.

Spectam (phonetic) was a drug that a lot of producers used, and probably
still do, that wouldn\'t be picked up on a stock test. And there are a
lot of producers that say, I can use this drug and I know you\'ll never
catch me. And they\'re wise to that.

So that\'s why if we can go to where the producer has to, or is
encouraged to \-- and I hate to get regulatory, but maybe pushed back
down from the plant that they asked for this, they get some \-- just
have a \-- maybe an MOU or a requirement, a specification that you have
documentation of drug use and it\'s only used under approval of the
veterinarian and withdrawal times are observed and all those things, and
only using approved drugs, so that \-- and I\'m speaking of drugs. There
are other things, too. The same thing would be for pesticides,
application of pesticides or wormicides or whatever else they use.

And some of those, it wouldn\'t be done on the veterinary deal, but
pesticides, for example, a pesticide applicator\'s license be required
\-- something that people have at risk that if they sign off on and say,
look, we follow the rules in this herd and if we get caught, we know we
are going to lose our license and we can\'t do \-- we\'ll lose a
livelihood rather than losing, you know \--

MS. FOREMAN: So you just want a flat statement that we\'ve got to have a
better way to, number one, regulate the veterinary drugs so they\'re not
available.

MR. JAN: Veterinary drugs and other chemicals used on animals, I would
say.

MS. FOREMAN: Okay. Can you get that, Mike, so we\'ve got a specific
about that.

MS. HALL: The poultry is fairly easy because all of the houses are on a
ranch. You know exactly what you\'re going to process, what day you\'re
going to process them, that kind of thing. And when you are talking
about cattle, you know, you bring them all in from different places.
It\'s not the same at all.

MS. MUCKLOW: Yes, worse yet, the problem is not the feedlot cattle.
You\'re going to find that feedlot owners are really fairly responsible
because they have a huge amount of dollars at risk if they have 25,000
or 50,000 head of cattle.

MS. HALL: And they have a veterinarian.

MS. MUCKLOW: And they have a veterinarian. And they have a hospital pen,
and they have records. And they do a lot that they keep good records on.
And it\'s probably more than their livelihood is worth to have unlawful
drugs like phenylbutazone sitting on the shelf there because they
shouldn\'t be using them.

The problem you have is the owner of a few animals, the owner of cows
and they give birth to little boy calves called bob veals. And they need
to move them out. And they\'re not standing up quite like they should.
And let\'s give them a little help. Let\'s give them a shot of
something. Who\'s ever going to know? And off they go to market. And if
he really wants to hide the trail, he can sell them to a dealer who then
peddles them around. And he knows where there\'s a soft veterinarian and
how he\'s going to get them through the system without them being
tested. The problem livestock we have come in very small numbers. They
don\'t come in flocks or herds or feedlot cattle. They come in very
small numbers, in \-- they\'ll come through a market. And the guy
that\'s going to move them is going to be somebody who\'s smart enough
to know he\'s got to cover his track.

Dr. Schultz at Taylor Packing Company, has done a very interesting and
helpful job in the last year. He has written a paper on it. He has said
we need to look at different criteria for testing these livestock. We
shouldn\'t just judge them on antemortem inspection. We should have
other criteria that we look at to determine. And that would be injection
sites and other things when the animal is already dead and hanging up in
the slaughterhouse. Those thoughts have been incorporated and accepted
by the Agency, and they have been significant in helping to improve the
residue situation.

But then the packer becomes the bad guy. And the guy who sold that
animal in and who did those things to that animal is lost somewhere out
there in the system. There is a burden on that packer to make sure that
he is not contributing to shielding the producer who has wrongfully
entered that animal into the food supply.

And Mark and I have spent a year working with an interagency group to
which people from FSIS and CBM and other agencies have participated in
trying to figure out some of the ways to resolve these issues. There is
a lot of reluctance out there by \-- especially by people who protect
those who are wrongfully using this system to put an animal with drug
residues into the system and think he can hide in the system.

We think we\'ve made some progress. I would like you as part of what
you\'re hearing tonight \-- Mark is better at describing this than I am
\-- to talk about the proposal that we have made to FSIS to change the
way in which they decide when somebody comes off the violator list.
Another piece of that puzzle is that we have asked that that violator
list be made available to the packers, because if they, indeed, know the
name and address, even if Joe Blow has his sister, Helen Blow, sell the
animal instead of him, we can begin to identify those people, because
Helen Blow\'s only going to do it once and she\'s going to be on the
violator list, too.

It takes time to do this. But at least the first step should be the
publication of that violator list by the Agency because these are people
that have been clearly put on notice in a certified letter from the Food
and Drug Administration that they have violated the Federal Food, Drug
and Cosmetic Act.

MS. FOREMAN: Is there any reason not to do that, Pat?

MS. STOLFA: I don\'t think so.

MS. FOREMAN: Okay.

MS. STOLFA: Because, as I say \--

MS. MUCKLOW: But it hasn\'t been done. We\'ve been asking for it for a
year.

MS. FOREMAN: We are willing to make some suggestions.

MS. MUCKLOW: Good.

MS. FOREMAN: Look, Mark, how long does it \-- we are now one hour into
our two-hour \--

MS. MUCKLOW: Please come and sit here and tell us.

MS. FOREMAN: Now, wait a minute, Rosemary.

MR. DOPP: I\'m waiting for an invitation.

MS. FOREMAN: Thank you. We have used one hour of a two-hour period. We
have not ordinarily in these meetings, since I\'ve been a member of the
committee, had people who are not members of the committee come sit at
the table and participate in the discussion. I\'m prepared to have you
make a short presentation of this.

I\'m really \-- you\'d have to overcome my objection to have somebody
who is not a member of the committee participate actively in a
discussion in the subcommittee. I can be voted down on that, but I just
want you to know we\'re setting a precedent if we do that. And it\'s a
precedent you might not like the next time when I show up with GATT.
Does anybody object to having Mark talk a few minutes about this?

MS. HALL: I object to it.

MS. FOREMAN: I beg your pardon?

MS. HALL: I object to it.

MS. FOREMAN: Okay. I just want you to understand that precedents are
precedents. And if you\'re going to come have somebody participate as a
member of the subcommittee, it\'s not something we\'ve done before. It
does have some implications. When you do it, you might find the next
time it\'s done in a way that you don\'t like.

MR. DOPP: Perhaps it would be preferable if I declined the invitation
under the circumstances.

MS. FOREMAN: I would be more than happy to have you share in a brief \--
and I really don\'t want to use up a lot of time talking about it. My
concern is having you participate as a member of the subcommittee.

MR. DOPP: I understand your concern completely. And that\'s why I\'m
suggesting, perhaps it would be prudent that I decline the invitation so
that the precedent not be established. Rosemary has done a very adequate
job of explaining what our priorities are.

MS. HALL: Thank you for your consideration.

MS. FOREMAN: I didn\'t hear you, Cheryl.

MS. HALL: I told him, thank you \-- thanked him for his consideration.

MS. FOREMAN: Thank you.

MS. RICHARDSON: And we also \-- there is an opportunity for public
comment tomorrow.

MS. FOREMAN: Yes.

MS. RICHARDSON: So certainly that would be a venue that he could share.

MS. FOREMAN: There is also a public meeting coming up where I assume
most of these issues will get discussed.

MR. JAN: I would like to just say a couple of things. When you\'re
talking about participating in our meeting, you\'re talking about
committee members participating in the subcommittee, because last time,
we had members that were not members of this committee participate in
our committee.

MS. FOREMAN: All right. I\'m talking about members of the Meat and
Poultry Inspection Advisory Committee \--

MR. JAN: Okay.

MS. FOREMAN: \-- as opposed to people who aren\'t members.

MR. JAN: Okay. Let me go on then so we can \-- I would like to kind of
build on this.

MS. HALL: One point on this real quickly. I think it\'s admirable that
people come from other subcommittees when they\'re through with theirs,
to our subcommittee. But I would appreciate their sitting in the
audience and listening rather than \--

MS. FOREMAN: I think we can take that up in the full committee.

MS. HALL: \-- rather than strongly trying to run the meeting. There are
times available during the full committee meeting when they can make any
comment they\'d like to. We have something to accomplish in our
subcommittee and we don\'t need other people disrupting it. And I think
that\'s the approach we should take from this point forward.

MR. JAN: If we can \-- if I can build on \-- before we got into this, on
what she was talking about. And Rosemary is exactly right, that a
majority of the residue problems are going to be from the minority of
the producers \-- I mean, just very small. They don\'t have the at-risk
like the feedlots. They don\'t have the feedlot veterinarians. They feel
that if they can salvage an animal without using \-- paying for
veterinary medical care and all that, they\'ll do that.

So I think that, you know, if we would urge the HACCP approach overall,
but then focus the sampling by FSIS on those that are the \-- come from
the small producers. They go through feed \-- I mean, they go through
auctions. And there may be a truckload of them. And you can\'t test that
truckload. You have to \-- but you view it then \-- take that 3,000 \--
or to get closer to that 99 percent, you might be able to pick up more
of those violators and identify more of those producers that violate.

And then when they start getting identified and enough of them get
identified \-- I mean, it\'s the same as the cop situation. If you have
\-- and you know there\'s a cop out there, people are going to start
stopping or slowing down. But if you rarely pick up because you\'re
testing the wrong animals, then it\'s going to be a rarity that you\'re
going to catch that violator and you\'re not going to have very many on
that list. So that\'s where I think we ought to focus.

MS. FOREMAN: If we\'ve talked about risk assessment, we should have a
risk management system that concentrates in those areas where the
violations are most common. That seems like a no-brainer.

MR. JAN: And I guess I\'d like to say one other thing, at least for the
record \-- that we don\'t get into a Supreme Beef situation with
slaughterers by expecting the slaughter plants to be responsible if they
find a residue violator or if FSIS has found a residue violator. Now,
someone \-- right now \-- and it makes \-- it\'s absolutely correct if
there\'s a residue, a violative residue in a tissue, that tissue is
condemned and doesn\'t go anywhere. But to penalize the producer, and by
saying, well, this animal that you slaughtered had a residue, then
we\'re going to condemn the whole carcass \-- and this carcass may
already be owned by that slaughterer and you have no control. And so we
need to, I think, be careful that the responsibility goes where the
problem is being incurred. And that\'s at the producer level.

MS. FOREMAN: Well, let\'s tease that out a little bit because if the \--
right now, if we do the testing and if it\'s an enforcement testing,
it\'s a test and hold, right? But where they\'re just doing the
sampling, by the time the sample \--

MR. JAN: It\'s gone.

MS. FOREMAN: \-- the sample comes back, it\'s gone, so \-- and the
action is taken back against the producer. Is that right, Pat?

MR. JAN: Yes. That\'s correct. That\'s what\'s happening now. I just
didn\'t want to get into the situation where we move this and say, okay,
so now it\'s the plant\'s responsibility. It\'s the plant\'s
responsibility, I think, as far as, if there\'s a violation, they need
to address it as either an unforeseen hazard or whatever in the HACCP
plan and then do what it takes, but not necessarily to hold \-- well,
like, say, three strikes and you have to close or something.

MS. FOREMAN: I think it is the Agency\'s intention that some \-- that
slaughter houses should assume that residues are a hazard reasonably
likely to occur. So \--

MR. JAN: I would agree with that. And those that are taking those
high-risk animals, I think they should address that situation. And then
\-- but what I\'m saying is, I\'m concerned \-- or I want to be sure
that we don\'t end up and say that even if you address it in your HACCP
plan and you\'re doing the corrective action, you\'re doing whatever it
takes, we don\'t come in and say, okay, you can now slaughter three
animals and there\'s residue \-- either you found them or we found them
\-- so we\'re going to withdraw your license or withdraw your grant. I
think we need to recognize that they need to do everything they can, but
they\'re not raising those animals.

MS. FOREMAN: We can have that on the record. And we should have on the
record that I disagree with you. So just \--

MS. HALL: How close are we still \-- I mean, we must be a long ways from
having a trace-back system for these animals. Is that still a long ways
\--

MS. MUCKLOW: Yes, a long way. And that \--

MS. FOREMAN: There is no legal authority. There is no legal authority.
Is there anybody here who objects to having \-- the Department having
legal authority to trace animals back? I sent that bill to the Congress
exactly 20 years ago next month.

MR. JAN: There\'s a guy by the name of, I think it\'s Weems that works
for FSIS?

MS. STOLFA: Weems? I don\'t know about that.

MR. JAN: Something \-- or Weimer, something of that nature, that said at
a meeting last week that there will be a national identification system
regulation within three years. Now \--

MS. FOREMAN: The Department does not have the legal authority to do it.
Do we want to say the Department ought to get the legal authority to do
trace-back?

MR. JAN: Yes, they could do that.

MS. FOREMAN: We could tell Gary Webbers (phonetic). Actually, Gary\'s
group has endorsed that effort, haven\'t they? Haven\'t the cattlemen
endorsed that?

MR. JAN: See, you\'ve got the Bird (phonetic) \-- or the \-- yes, the
Bird system now, which is a brucellosis thing. And if they would just
expand that, it\'s already in place. But brucellosis is going to be
controlled. And actually, it\'s down to about \-- Texas is about the
only state. And so as that\'s gone away and the states don\'t have it,
they\'re no longer able to trace that.

In Texas right now, we can trace. We can call the Texas Animal Health
Commission. Most animals are going to have a tag for brucellosis, either
for \"vaccinate\", or if they were sold or tested. So \-- but it won\'t
be around very long. So I don\'t know where that authority is and if
that could be \-- you know, go to that authority rather than to FSIS.

MS. FOREMAN: But USDA does not have that authority nor does \-- nobody
has that authority at the federal level right now. And in fact, the last
time the administration sent a bill to the Hill, it didn\'t include that
although it had previously. I don\'t know why it got dropped out, but it
did. So that\'s \--

MR. ABADIR: The issue of tolerance is what we\'re talking about now,
different agencies here. Is the tolerance area, clear tolerance levels
being specified or would it be strictly going back afterwards to debate
which tolerance would be taken?

MS. STOLFA: I think the responsibility on that is clear, that FDA sets
the tolerances for animal drugs. EPA sets the tolerances for pesticides
and other potential environmental contaminants. And both of them, more
so FDA, have worked very hard over the past 15 years to sort of round
out that picture so that there are clear tolerances. And EPA is engaging
in a process of reviewing its tolerances and action levels under F2PA or
whatever the name of that statute is.

So although we actually have authority, we have never staffed our Agency
to do that ourselves. We could do what we have never chosen to do, but
we don\'t have the people that do the kind of risk assessments that are
at the foundation of tolerance setting. And we would not see the need
for us to do that as long as it\'s adequately done by others people.

MS. HALL: Are you seeking the \-- you\'re talking about testing methods,
et cetera \-- are you seeking funding for ARS or some help with new
testing methods for residues?

MS. STOLFA: We do that. A lot of the work that ARS does for us applies
to methods development. We\'re actually hoping to stimulate the private
sector to go ahead with some stuff that we think they can do. So it\'s
kind

of \-- there really is \-- I mean, you need to understand, there\'s not
going to be enough federal money to do all the things that need to be
done. You know, there simply isn\'t. And so why not \-- and I would say
there never has been. You know, you may be comfortable with what we\'ve
done, but we have never done as much as we could have, had we had more
money. We\'re sort of specifically out of the methods development
business ourselves. So we do our best to stimulate other people to do a
good job with it and get on with it.

MS. FOREMAN: Is there a major area of ARS work that ought to be done
that would \--

MS. STOLFA: ARS can certainly contribute to that. But they do some
methods development work. And I have not looked closely enough at their
research in recent years to tell you sort of how it breaks out. And you
know, it\'s certainly worth investigating to see what you all think
about that.

MS. MUCKLOW: Pat, who is in the Office of Risk Assessment \--

MS. FOREMAN: You ought to have some there that maybe \-- going to \--
exploring with ARS, more research into methods development. Did I say
that right? Is that where we were going?

MS. MUCKLOW: Pat, isn\'t the Office of Risk Assessment Cost Benefit
Analysis within ERS or ARS?

MS. STOLFA: Neither. It\'s a separate office that reports to the chief
economist.

MS. MUCKLOW: Okay. And he \'s not within ERS then, Keith Collins? Okay.
So he\'s in the Office of the Chief Economist.

MS. STOLFA: Yes. He is the chief economist. He has a small office. You
know, he oversees, like, ERS, not ARS. But he oversees \--

MS. MUCKLOW: ERS, yeah.

MS. STOLFA: \-- ERS. And he has those, you know, the \-- reports.

MS. MUCKLOW: I see. So it\'s an administrative office that reports to
him.

MS. STOLFA: Right.

MS. MUCKLOW: Okay.

MS. HALL: On one of the questions, question number 2 \-- I have big
concerns with that, the international residue testing, because of \-- a
lot of other countries have drugs cleared for use in their countries,
which do produce residues and they are drugs that cannot be used in this
country. And there\'s not really an adequate system for testing, I
don\'t believe, for testing those things that are imported under those
other, foreign veterinary systems.

MS. STOLFA: It\'s certainly true that if we haven\'t approved it, we
don\'t have the method for it.

MS. FOREMAN: Well, then maybe our recommendation about exploring with
ARS, the methods development ought to be \-- include the notion that we
ought to have methods for drugs that are widely used in other countries
and not permitted.

MS. HALL: You see, how it looks to the veterinary community here is that
drugs that are not allowed to be used here can be used in other
countries. And we\'re just supposed to accept that product as being fine
and dandy. That should not be. And there\'s a reason that it\'s not
approved for use here.

MS. FOREMAN: Yes. And I really \-- actually, I was going to ask if we
could look a little bit, since we\'re down to 45 minutes, at the
questions that are asked here. And there are \-- 1 and 3 have some
public questions about them. And can we do it a little bit with number 2
and then come back, maybe, and look at 1 and 3 for a few minutes, too? I
think \--

MS. MUCKLOW: Could we focus on number 2 where Codex is, on residues?

MS. STOLFA: Yes. And you could get more complete advice from people
other than me. Codex has made some effort to sort of even out the
playing field. The difference is \-- and by all means, you know, explore
that with Codex.

You know, what is the name of that committee that \-- it\'s an expert
committee that looks at minimum residue levels within the context of
sanitary, phytosanitary agreement where you can\'t really do things to
other countries \-- take all this sort of with a grain of salt \--
you\'re not supposed to do things to other countries that you\'re not
doing to yourself.

And there are ways for trying to equalize this sort of thing that are
specifically looking at residues. And someone other than me should give
you an up-to-date report. There are efforts.

MS. FOREMAN: There are at least two issues here. One is the use of drugs
in other countries, that are not allowed here. But there is the other
issue of most other countries not having residue control systems that
are as good as ours. And not having \-- I don\'t know if our import
inspection is adequate to cover that. I just don\'t know.

MS. HALL: With as much regulation and control of licensing and
everything as we have here and we still have problems with residues, you
can imagine in other countries how much \--

MS. FOREMAN: I\'m sorry, Donna?

MS. RICHARDSON: Well, picking up on what you\'re talking about is
looking at \-- we want more control over the import process so that we
aren\'t accepting animals with residue that would not be allowed here,
much the same way that you have drugs that are used in England and
France and that are approved there, but can\'t be used here because the
FDA hasn\'t approved them.

The second part is \-- which goes on all the

time \-- is that we send expired drugs and other things to other
countries that are not allowed to be used here. And so, one, we should
be looking at import to make sure that the system here stays
unadulterated, but then also doing the right thing and looking at how we
can prevent the export of residue.

MS. FOREMAN: I think we\'re looking hard at addressing \-- we\'ve been
talking about how we address the issues, making sure we are not getting
residues in our \-- how to improve the system that prevents domestic
residues, which would affect our export products.

MS. RICHARDSON: Right.

MS. STOLFA: Which eventually also affects our \-- that\'s a two-way
street. Remember, we are both a big exporter and a big importer. And you
know, that \-- I can remember in \-- about the time that this report
came out, at the behest of the Congress we delisted six Central American
countries for inadequate residue programs, and we threatened to delist
more than half of the \-- what was then still the EC. And don\'t think
they don\'t remember that. So as I say, it cuts both ways on this. And
you have to balance. You have to think about both sides of the equation
when you get into the international stuff.

MS. FOREMAN: But no one objects to restrictions if those are based on a
risk assessment and it is being applied with an even hand in terms of
the risk management, so that it\'s being applied domestically as well as
internationally. In other words, you know, the treaties require
evenhanded treatment. We can delist countries that don\'t have meat
inspection systems that come anywhere close to meeting ours.

MS. MUCKLOW: Since Mr. Billy is the chairman of Codex at the moment, I
would suggest that we ask him at what level or stage Codex is in
rationalizing \--

MS. FOREMAN: Good.

MS. MUCKLOW: \-- this issue.

MS. FOREMAN: Why don\'t we, in fact, ask him if during our report
tomorrow he\'ll take a few minutes to do that? Is that what you\'re
suggesting?

MS. MUCKLOW: Uh-huh.

MS. FOREMAN: That we get a quick report from the Codex chairman.

MS. HALL: When the Russian Treasury was being worked on for poultry and
a Russian veterinarian came and visited poultry plants, came with his
interpreter, the first question he asked when he came in was, \"Do you
use chloramphenicol?\" Everybody went, wow.

MS. RICHARDSON: But this \-- and this also relates back to the first
question about public participation in designing the program, because
getting back to pesticides, which I worked on when I was at OSHA and
that I have dealt at FDA, is that when the public becomes educated about
the possible health effects, then the public says, no, I\'m not going to
buy fruit that comes from a specific country, because of the concerns
about what they\'ll be exposed to. And it will be the same thing, doing
the same kind of educational program when you talk about meat, that has
been done with apples and grapes and fruit. So you can\'t get public
participation until you educate the public about what the possible
problems are.

And certainly, I think the public in Iowa and Texas and Arkansas that
are also involved in the industry may know more about the problem than
the public in New York City and Washington, D.C., and Baltimore. So I
think you\'ve got to have a public education campaign just like we did
with fruits and like we\'ve done now with apple juice and other things.

MS. FOREMAN: Well, I would like to follow up on that. The Food Marketing
Institute has now got, I think, 25 years of their supermarket shoppers
survey. And it is shocking that the stress level about chemical residues
and food additives continues to be substantially higher than public
concern about pathogens. They didn\'t ask about pathogens until just a
few years ago, and that question got subsumed under spoilage and other
things. They started asking it and the level of concern has \-- about
pathogens has progressively gone up.

But the public\'s level of concern about residues is very high. And
anytime there is any sort of hint of a scandal, there tends to be a very
strong reaction because if you get into Peter Sandman\'s outrage
factors, that, you know, the risk equals the hazard plus the outrage \--
and people react strongly to those things where they feel they have no
control. They can take the chicken home and cook it. But I can\'t cook
the residue out. And cancer, the dread disease, gets raised in this
context.

I\'ve got to tell you, though, I think living in an international \--
living with the global marketplace and with information systems that
make instantaneous communication, means that when there\'s a dioxin
scare in Belgium, we will have fallout here, and that it would be
beneficial if we can find some way to talk about residues in a way that
over a period of time educates the public.

And that we might be able to do that in a positive way instead of in a
response to some sort of contamination. So that \-- you know, I went and
made a speech last week to a couple of hundred women, all of them, as
they like to describe themselves, overeducated mothers who are staying
home to care for young children. And they were much less concerned about
Salmonella than they were about dioxin, and less concerned about that
than they were about stryoline (phonetic) corn.

So I don\'t how to do that. But it sure seems to me it would be worth
pursuing. I agree.

MS. MUCKLOW: We have another problem, which was the Swiss problem we had
a year or so ago. We didn\'t have any laboratories in this country, to
the great embarrassment of the government, to even test for what they
said they found in Switzerland. And that was a great embarrassment to us
internationally. They have to go to Canada to find a lab to do that.

MS. FOREMAN: Was that the BDS?

MS. MUCKLOW: We\'re the greatest country in the world and we had to go
to our poor little neighbor to the north, to get the tests run.

MR. JAN: That\'s why we\'re so good; we know where to go.

MS. FOREMAN: I was thinking that it meant that they were sending some
money up there so they could afford to buy some American feed.

MS. MUCKLOW: They don\'t buy a lot of our beef.

MS. FOREMAN: I don\'t know any way, though, to \-- that starts off with
how you encourage public participation, and maybe instead of having just
public meetings, that the Department engage in some seminars among
public health people, APHA, nurses, other people who have at least some
basic information about science, and see if you can start with a core
that builds out.

MS. RICHARDSON: And I think one of the \--

MS. FOREMAN: Excuse me. Science writers.

MS. RICHARDSON: But I also think one of the untapped resources, because
I\'m looking at the number of nutritionists that are working on women\'s
health and working on the cancer aspects now of, you know, is it fat,
you know, is it fiber, whatever, is using this growing group of
nutritionists \--

MS. FOREMAN: A great idea.

MS. RICHARDSON: And a number of whom are \-- you know, they\'re working
with diet groups, and some of the physicians\' practices now have them
on, you know, their own staff \-- is tapping the nutritionists and using
them for that education as well. The educational system \-- I don\'t
know. I don\'t know if they make people take home ec \--

MS. FOREMAN: No.

MS. RICHARDSON: \-- like they used to. When I was in school, all the
girls had to take home ec, all the boys had to take shop. We couldn\'t
take shop, they couldn\'t take home ec. My godson in the seventh grade
\-- the boys had to take home ec.

So in looking at whether or not the educational system can also do some
of this teaching \-- you know, the only reason people talk about
Salmonella and stuff now is because now you\'ve got Clorox wipes versus
Lysol saying, you know, when you spill that chicken, just wipe it right
up. So they make it a marketing issue in doing the education.

MS. FOREMAN: Oh, the American way.

MS. RICHARDSON: Yes. And so I don\'t know if there\'s a marketing factor
that will help you with the education.

MS. FOREMAN: Yes. But maybe somebody would like to market little litmus
strips that would turn red if you\'ve got a residue.

MS. RICHARDSON: I mean, the other \-- the only other thing \--

MS. FOREMAN: You can use them first.

MS. RICHARDSON: \-- is looking at, you know, what Dr. Koop did when, in
\'84 or \'85 when we were first talking about HIV disease, and then
it\'s like every household got a little pamphlet that said, this is what
HIV disease is, this is what it isn\'t; this is how you protect
yourself, this is what you need to do. But it also means that you have
to have that commitment in order to spend that money and to do that kind
of educational campaign.

MS. FOREMAN: Yes. And I\'m not sure that kind of educational campaign
will happen until there\'s some terrible scandal about a residue, which
we hope will never happen. But I think the notion about nutritionists,
because they\'re \-- the American Dietetic Association now has this
corps of people who are out talking about policy issues. And they have
lots of continuing education efforts, so \-- seminars for them and for
public health people, state government public health. Have they still
got public health educators that \--

MS. RICHARDSON: FAHA.

MR. JAN: Yes. Another thing was the Food Safety \-- National Food Safety
Month here in September is a different focus.

MS. FOREMAN: Oh, that\'s a good idea.

MR. JAN: And so that could be \-- and you know, you have to be careful
that people don\'t perceive this as another big government scare thing.

MS. FOREMAN: Absolutely.

MR. JAN: And you know, there\'s going to be a certain number of people
just, like, they still smoke, that says, you know, it\'s just a plot or
something. And so you have to be careful \-- maybe target who this
public is, like you mentioned about the Public Health Association or
public health officials or nutrition people or people that \-- but if
you just kind of go out and there\'s a whole big campaign, I\'m afraid
that it might backfire and they\'d say, oh, you\'re just trying to scare
us.

MS. FOREMAN: That\'s a good point.

MS. RICHARDSON: And you also have to have the industry to buy into it
because you don\'t want the industry reacting to it like they did to
Oprah and mad cow disease, you know, them saying that we\'re trying to
persuade people not to eat meat.

MS. FOREMAN: Yes.

MR. JAN: Yes, it would have to be credible.

MS. FOREMAN: Yes. Well, I think we have the advantage here with
residues, is that we do have a pretty good system that has kept them
under control. And the time to start that kind of process which you
recognize here is when you don\'t have a panic and you can develop
rapport with the people who have some training that makes them inclined
to accept and understand the issues here, so that if and when the day
comes, there are people out there who understand, because once again,
the fright factors with residues are so much higher than they are with
pathogens. And people do \-- all you have to do is remember Alar.

And the best line I ever read about that was in *The Washington Post*,
where the guy went and interviewed people who had driven across town to
the organic market to buy organic apples so they could be sure to avoid
getting Alar apples. And about 40 percent of them confessed that they\'d
driven across town without hooking their seat belts.

MS. MUCKLOW: Well, in my view, the veterinary drug issue needs to be
framed very much like the human drug issue \-- and that when you\'re
sick, you go to the doctor and the doctor checks your vital signs. And
he decides you\'ve got some illness that he\'s got a medication that\'s
going to be able to help. And that\'s also what happens in the animal
business except that it isn\'t the doctor, a medical doctor. It\'s a DVM
who prescribes certain drugs to treat an animal to make it better again.

And just about every family has a pet in this country. They understand
something about treating a sick animal and they certainly understand
about treating sick children. And I think it can be put in that kind of
frame of reference.

Part of the responsibility is that just like you know you\'ve got to eat
all the antibiotic pills if you have an infection and you get treated
with it, so there has to be responsible use of veterinary drugs in this
way, to make sure that the livestock that we slaughter for food do not
contain them. We have got laws that say that those animals should not
enter the food supply. And everybody needs to play their role, including
the veterinarians who prescribe those drugs.

I think it\'s a very plausible story to be told to the American public
if it\'s told in the right way.

MS. FOREMAN: And that way, you have a little bit better control over the
availability of some of those veterinary drugs.

Are there other \-- we haven\'t gotten down into some of these, and
we\'ve got about 20 minutes.

MR. JAN: Well, I think number 5 could be answered very quickly, just to
kind of put that off on \-- let\'s continue \-- or encourage the Food
Safety Committee where we really have interagency \--

MS. FOREMAN: Or the President\'s Food Safety Council. Kick this up to a
level where there might be some \--

MR. JAN: Yes, get them involved \--

MS. FOREMAN: \-- some clout behind it.

MR. JAN: \-- to \-- right.

MS. RICHARDSON: And we made some of those points when we first started.

MS. FOREMAN: Yes, yes. And I think we probably addressed the small
producer, packer and the contest \--

MR. JAN: Yes, and maybe just for the opposite of the way this question
is asked, because this is talking about how it impacts, well, we might
say that it actually impacts \-- they have the biggest impact on the
residue problem. At least we have to keep that in mind, that

they \-- how they impact residue product.

MS. FOREMAN: And to the extent that we want to institute a HACCP system,
that you want to be sure you have a risk management system that focuses
on those people who are the problem, as opposed to just \--

MR. JAN: Higher risk rather than problem, maybe.

MS. FOREMAN: Okay, higher risk. Yes.

MR. JAN: But the small producer would be higher risk, the individual
producer, mixed loads, all those \--

MS. MUCKLOW: The dealers and \--

MR. JAN: The dealers, yes, the livestock markets.

MS. FOREMAN: I want to tell you, when I was at USDA, we were in the
height of the sulfur residue issue. And it was overwhelmingly people who
bought their hogs at auction. And part of the reason the hogs were at
those auctions was \--

MS. HALL: They were hiding them.

MS. FOREMAN: \-- they were hiding them. You\'re exactly right. And
because then FSQS couldn\'t go on the farm and no one would let FDA go
on the farm because they assumed that they\'d found a residue that would
be subject to legal action, we made a deal and everybody agreed that
APHIS would go and try to find why it was that people said, I\'m
withdrawing, I\'m following all the rules and I\'m still getting
residues.

And we knew there was a problem, but we couldn\'t find somebody to go to
the farm that they would let come on the farm. And interestingly, what
we found was exactly consistent with what you said earlier. We had a lot
of people who would run medicated feed through a feed mill, you know,
they\'d do the mixing.

MS. MUCKLOW: They never cleaned the feed mill.

MS. FOREMAN: So then they\'d take another batch of feed they felt
wasn\'t medicated. Well, it\'s sure medicated enough to show up in the
residue samples. So I\'m assuming that all these years later now, you
know, that that isn\'t this kind of problem. But it was a regular
problem then.

MR. JAN: And also another risk \-- and it depends on how big the
operation is \-- particularly swine, if you set a sick pen up and you
have a trench drain where you flush manure down, then you\'ll start
medicating these pigs down here because they recycle the food one more
time, you know, particularly if they don\'t have enough in their food
\-- .

So those things can happen. I mean, I think the big, sophisticated
operations have figured that out. But a lot of the smaller ones just
don\'t have the scientific background. You know, there are just a lot of
reasons. So that makes them higher risk, not necessarily a problem, but
a higher risk which, I guess, becomes the problem then.

MS. FOREMAN: Well, Pat, have you got \-- has this been helpful to you in
planning your meeting and \--

MS. STOLFA: Yes, very helpful.

MR. ABADIR: I have a comment I would like to say here, which I have
experience with , is countries that produce an item or export it, they
have the know-how of what \-- go into this product. So by going to the
information that you get from other countries, you would find a lot of
answers to some of the residues that are mostly coming, especially
something that was very clear to us when we were dealing with seafood
like salmon.

I\'m talking about Iceland, Norway or Chile. They have been through a
lot of work here in testing. It seems like that they have references to
a lot of residues that they know specifically where to go and what to
find. Lamb, for example, in New Zealand, I\'ve done a lot of research on
that. So that\'s why I was telling you information that can be utilized
rather than working from New Zealand on it.

MS. FOREMAN: Who besides Canada ships live cattle into \-- live animals
into the U.S. for food?

MS. STOLFA: Mexico.

MS. FOREMAN: Mexico? I thought we shut them down.

MS. STOLFA: No. We let some relatively young cattle come in and are
finished on feedlots here.

MS. FOREMAN: Okay.

MS. MUCKLOW: They don\'t come in direct for slaughter, do they?

MS. STOLFA: No.

MS. MUCKLOW: No?

MS. STOLFA: They\'re too young and they are finished on feedlots.
That\'s quite what the trade is at this point.

MS. FOREMAN: So we do have a concern about trace-back to a producer that
does extend in a couple of cases across international borders.

MS. STOLFA: Absolutely. We regularly get some \-- both \-- cows and, I
think, calves from Canada. And there\'s a couple of issues. They\'re
producing compounds for use in, for instance, veal calves that we
don\'t. And now we\'re kind of looking at a problem with veal calves
that FDA has asked us to look into. And a definite aspect of it is the
\-- what about the Canadian trade and how are we going to handle that.
The same kind of letter that goes to a U.S. producer we send to a
Canadian producer if we find residue violation.

MS. FOREMAN: Can we trace back? If it goes across the border, can we
trace them there?

MS. MUCKLOW: Yes, because \--

MS. FOREMAN: Hopeful, but \--

MS. MUCKLOW: \-- those animals that come in, if they come direct from
slaughter \--

MS. FOREMAN: Right.

MS. MUCKLOW: \-- are excluded from certain inspections at the border.

MS. FOREMAN: Yes.

MS. MUCKLOW: They come direct to a slaughterhouse and they\'re known
exactly where they come from.

MS. FOREMAN: That might be a nontariff barrier.

MS. STOLFA: But many other countries have more extensive and more
consistent animal identification systems than we do.

MS. HALL: What about something like Argentinean corn beef? The animals
are from Argentina, they\'re slaughtered there. And it\'s canned and
sent here. That\'s a big import product, it\'s my understanding.

MS. STOLFA: It\'s only an import product, I think. We don\'t make that
here.

MS. HALL: No.

MS. MUCKLOW: The animals that come from Canada \--

MS. HALL: So those are not the best animals \--

MS. MUCKLOW: \-- into our feedlots have to undergo animal health
inspection in this country \--

MS. STOLFA: Oh, yes.

MS. MUCKLOW: \-- but if they come direct to a slaughter plant to be
slaughtered within X number of days, they are exempt from that because
they\'re going through federal inspection in the slaughter plant.

MS. STOLFA: In the case of countries that are eligible to export to the
U.S., the requirement is that they have residue control systems that are
equivalent to ours. We do a rather \-- I don\'t exactly know what they
do in any of their programs now, but I\'m sure that the programs are not
less intensive than what we did do 15 years ago. We do an extensive
review of their residue control programs, including their laws and
regulations, their laboratories, the methods they use, the results they
get.

In the case of Argentina, we used to go around the world 15 years ago
and say, look, nobody can test for everything. They tested every animal
in Argentina that went into corn beef. They just said that we\'re going
to test everything because it was essentially an American company that
owned \-- or a couple of American companies that run that operation. At
the time, it was certainly big companies \--

MS. MUCKLOW: Another wrinkle that you might be interested in too on that
one is that is if an American company is slaughtering those animals that
are direct shipped from Canada but is also producing for the school
lunch program, he has to have a totally segregated program to make sure
that only domestic animals go to school lunch.

MS. FOREMAN: Unless it\'s strawberries.

MS. HALL: And they have a veterinary health certificate.

MS. FOREMAN: Yeah. Has anybody else got anything to add?

MR. JAN: No other thing that I know.

MS. FOREMAN: Well, Pat says we\'ve helped her a little bit, so \--

MS. STOLFA: Yes, thank you very much. I hope some of you might be
available on the 11th, either to participate in the meeting or maybe to
help us and facilitate in some of the groups.

(Whereupon, at 8:45 a.m. on Tuesday, October 31, 2000, the meeting was
concluded.)

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CERTIFICATE OF REPORTER, TRANSCRIBER AND PROOFREADER

[Residue Control in a HACCP Environment - Subcommittee 3]{.underline}

Name of Hearing or Event

[Washington, D.C.]{.underline}

Place of Hearing

[October 31, 2000]{.underline}

Date of Hearing

We, the undersigned, do hereby certify that the foregoing pages, numbers
[1]{.underline} through [56]{.underline} , inclusive, constitute the
true, accurate and complete transcript prepared from the tapes and notes
prepared and reported by [Muriel Barclay]{.underline} , who was in
attendance at the above- identified hearing, in accordance with the
applicable provisions of the current USDA contract, and have verified
the accuracy of the transcript (1) by preparing the typewritten
transcript from the reporting or recording accomplished at the hearing
and (2) by comparing the final proofed typewritten transcript against
the recording tapes and/or notes accomplished at the hearing.

[11/8/00]{.underline}

Date Bonnie J. Niemann

Name and Signature of Transcriber

Heritage Reporting Corporation

[11/21/00]{.underline}

Date Lorenzo Jones

Name and Signature of Proofreader

Heritage Reporting Corporation

[10/31/00]{.underline}

Date Muriel Barclay

Name and Signature of Reporter

Heritage Reporting Corporation