FOOD AND DRUG ADMINISTRATION COMMISSIONER'S VIDEO TELECONFERENCE CHICAGO DISTRICT

FOOD AND DRUG ADMINISTRATION
COMMISSIONER'S VIDEO TELECONFERENCE
CHICAGO DISTRICT
Chicago, Illinois
Wednesday,
April 28, 1999
2:30 p.m.
ON BEHALF OF THE AGENCY:
RAYMOND MLECKO
District Director
Chicago District
VIRGINIA CONNELLY
Executive Officer
JOSEPH LEVITT
Director
Center for Food Safety & Applied Nutrition
DAVID ARMSTRONG
Associate Director for Research
Moffett Center
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I N D E X
SPEAKER
JOSEPH A. LEVITT
Director, Center for Food Safety and
Applied Nutrition
DR. DAVID ARMSTRONG
Associate Director for Research
Moffett Center
PAGE
3
37
JOSEPH DOSS
Consumer Health Care Products Association
44
KAREN TRUSKOWSKI
50
NANCY DONLEY
Safe Tables are Our Priority
59
SHIRLEY BOHM
Illinois Department of Public Health
67
MERLE SOSA
Food Animal Concerns Trust
71
KEN MOORE
Interstate Shellfish Sanitation Com.
78
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P R O C E E D I N G S
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MS. CONNELLY:
2
I just want to thank everybody for
3
returning for the continuation of our program today.
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going to begin the panel discussion portion of today's event.
We have three distinguished FDA panelists:
5
We're
Mr.
6
Joseph Levitt, the director of the Center for Food Safety and
7
Applied Nutrition; Mr. Ray Mlecko, the District Director of
8
Chicago and Detroit District; and Dr. David Armstrong, the
9
Associate Director for Research at the Moffett Center, which
10
we heard about this morning from Dr. Henney -- or earlier this
11
afternoon.
12
Mr. Levitt will be monitoring the remainder of the
13
discussion after he makes a presentation, but let me just remind
14
everybody to use the forms that have been provided for questions
15
and comments, and if you'd like to make a presentation or ask
16
your question orally, there are microphones set up in the middle
17
aisle.
18
Joe?
19
MR. LEVITT:
Thank you very much.
It's a pleasure
20
for me to be here today, but most importantly, it's a pleasure
21
for me to see so many of you here today.
22
the local district staff, who organized the local end of this
23
conference, and for getting the word to all of you to come.
Let me begin by thanking
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I have seen and talked to a number of people in the
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2
audience, especially our state and local counterparts and
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consumer industry representatives in the audience.
4
Also, David Armstrong will have a few words after
5
me, and I'm just trying to figure out what they had to trade
6
over at the Moffett Center to get that paid political
7
announcement from Dr. Henney.
8
I can assure you that it was well -- it has been one of FDA's
9
best-kept secrets, and I think it's good that we are unveiling
10
it, because it really is at the heart of a lot of our food-safety
11
efforts that we're trying to accomplish.
But having visited it myself,
I have a fair amount of information that I'm going
12
13
to try to run through.
A little bit I'm almost going to rush
14
through as a way -- we can come back during questions and
15
answers.
16
For those of you who do not know me, I'm the director
17
of CFSAN, the Center for Food Safety and Applied Nutrition at
18
the FDA and headquartered in Washington.
19
FDA for 20 years, and I've worked in almost every part of the
20
FDA.
I have been at the
I became director of this center about a year ago.
21
A lot of what I'm going to try to do, then, is to
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give you a little bit of a sense of, number one, who we have
23
put together as our senior team within the center, running the
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National Foods Program; number two, having been in the job a
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little more than a year, give you a little bit of a report card.
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What was I saying last spring that was going to be
4
done?
How are we doing on it a year later?
Note some specific
5
accomplishments, and then talk a little about the budget.
6
There's a lot of interest; you've heard some of that.
7
of what you're going to hear reinforces and gives you a view
8
of the foods version of what Dr. Henney was saying.
A lot
Let me begin with the CFSAN management team.
9
We
10
have put together a group of, in addition to myself, five or
11
six people that have a variety of backgrounds and experience:
12
13
Janice Oliver, who was the food spokesperson in the
14
FDA studio audience that you saw before, has been at FDA for
15
30 years.
16
been at the center for the last ten years, and really was the
17
person at FDA most directly responsible for getting the
18
food-safety initiative off and going and off the ground.
Most of her background is in the field, and she's
19
Number two is Bob Lake, who has actually spent this
20
entire year in the Center for Food Safety and Applied Nutrition;
21
is known to especially to those that have worked on the Hill;
22
it's involved a lot of legislation activities.
23
We have just recruited -- I was very pleased when
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he was brought up to FDA -- Dr. Morrie Potter, who has 25 years'
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experience in foodborne illness down at CDC.
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many in Washington, because he's been in many ways the Washington
4
connection, but he really brings a strong public-health
5
perspective to the issue, which I think is absolutely critical.
6
Number four, we have Bob Buchanan, who is my senior
He is known to
7
science advisor.
I'm a lawyer; people don't know that.
8
are a science-based agency.
9
position that I would surround myself with strong scientists.
10
Morrie Potter and Bob Buchanan are but two examples of that.
I pledged when I was put into the
11
Dr. Buchanan came from the USDA Agricultural
12
Research Service up in Philadelphia and has a wealth of
13
background and knowledge in a variety of programs.
14
15
16
We
And finally, our executive officer, Juanita Wills,
who I'll just say, by coincidence, comes from the EPA.
And so just within this group, what I've tried to
17
put together is people that, number one, are experienced.
18
the junior member of the team, with 20 years federal experience.
19
20
21
Number two, they have a variety of experience:
I'm
We have the
FDA field, FDA headquarters, other parts of FDA; CDC, USDA.
We have new problems.
Dr. Henney talked about the
22
changes that are happening in the food supply.
23
problems; we need new solutions, and therefore we need a variety
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We have new
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of perspectives on the subject.
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And finally, we have a commitment of people who want
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to work together, not only with each other, but with the other
4
counterparts around the other agencies.
5
go back and forth between different agencies -- people have
6
gone from FDA to USDA, also -- we actually now have a person
7
stationed at CDC; CDC has a person stationed at the FDA -- we
8
are recognizing more and more that it's critical that we think
9
of ourselves as a single food establishment, because from the
10
consumer's point of view, the consumer, I'm sure, doesn't look
11
at their plate and say, Oh, I'm eating an FDA-regulated product;
12
ooh, I'm eating a USDA-regulated product; I'm consuming
13
something that the states are responsible for.
14
The consumer doesn't care.
And so by having people
The consumer wants safe
15
food, period, and it's our responsibility as federal and state
16
food-safety officials to look at our missions more broadly,
17
to look at blurring the lines but strengthening the connections,
18
and I'm starting that internally here at the FDA.
19
Now, report card from last spring:
I gave a variety
20
of speeches to a lot of groups last spring, and I stressed,
21
number one, values that I bring -- I'll talk about that -- number
22
two, food safety as our top priority; number three, the need
23
to set priorities in the other areas of the foods programs,
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and, four, and probably most importantly, the need to show clear
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accomplishments.
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something for the benefit of consumers.
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how we're doing.
We need to show we're here and we're doing
Number one, values:
5
So let's see at least
One of the first things I
6
did -- I'm new to a lot of you; when I came to CFSAN, I was
7
new to a lot of people there, too, and so one of the first things
8
we did was say what are the values that we bring to the table;
9
what is the foundation that is underpinning what we want to
10
11
do?
We put together this rather simple slide that talks
12
about public health and safety as I talk:
priority; respect
13
for our stakeholders, for ourselves, for the law; integrity,
14
objectivity; dedication, and dedication to excellence.
15
put that down the side and you see the letters PRIDE; that's
16
not a coincidence, obviously, and we have signs and posters
17
throughout our center talking about CFSAN PRIDE and really
18
trying to reinforce that we want a system that has high
19
standards, that is responsive to stakeholder needs but, above
20
all, has a dedication to excellence and to safe food.
You
21
Number two, talked about the food-safety initiative,
22
and one of my favorite slides was, knowing it's a presidential
23
initiative, I knew my priorities:
food safety, food safety,
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and food safety.
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still spend most of my time on.
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And that really is what I at least began and
The vision is clear:
We have to reduce the incidence
4
of foodborne illness.
5
challenged, and we recognize they are soft, but the numbers
6
that are out there of 9,000 deaths, 6 to 33 million illness,
7
those are too many.
8
one way or another; it is too many.
9
The numbers -- and these numbers are
It doesn't matter if it's off by 50 percent
And if there's one thing I could change and will
10
try to change at the FDA, it's not so much the focus on just
11
the product but the focus on the impact on the consumer.
12
got to reduce the incidence of illnesses.
13
really know if we're doing the job properly.
14
in place to help measure and gauge that, but we really want
15
to change vision to foodborne illness and away from just looking
16
at the product for product's sake.
17
We've
That is when we'll
We have systems
Now, how are we doing in the first year?
Number
18
one, we have what I call laid -- we spent a long time laying
19
a strong foundation for the program.
20
building blocks of the food-safety program.
21
There are six major
Number one is surveillance.
Through CDC we have
22
put in place the new FoodNet system and the new PulseNet system
23
that are now in place.
They need to be expanded and enhanced,
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but a major advance is to get those systems in place.
Number two, we have a clear research agenda within
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3
FDA.
We have a three-year research plan; we also have a
4
cross-government research plan for produce and other
5
activities.
Number three, risk assessment:
6
We really have to
7
take a stronger look at risk assessment, be sure that we are
8
addressing things that have the highest risk.
9
consortium of agencies to establish a risk-assessment
We have a
10
consortium, and we are establishing a clearinghouse to collect
11
information on risk assessment and exchange it through our
12
collaboration with the University of Maryland.
We have, number four, education:
13
the
14
public-private partnership.
I see in the back the back puppet,
15
the Fight Back campaign; Janice Oliver referenced that also.
16
It is a critical part of what we're trying to accomplish, as
17
well as education for retail and food-service establishments.
Fifth part of the building block is outbreak
18
19
response.
We have something called Force D, which is a broad
20
coordination unit, but more important than that is at the
21
operational level we're working very hard and diligently to
22
get in better systems so outbreak response will really result
23
in early detection and containment, and we are getting there,
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and PulseNet is helping us out with that.
And the sixth building block is really the FDA
2
3
outcome, which is the inspection.
We have -- are implementing
4
this year our Seafood HACCP program, during 1998, as USDA did
5
with meat and poultry, and we are seeing improvements across
6
the board.
7
And the importance of that is the money that Congress provided
8
is not designed to be a one-year fix.
So our year number one, we have the foundation.
It was designed to really change the landscape and
9
10
the direction of how we're approaching these issues.
And so
11
I see that first year foundation as an investment in the future,
12
not just what happened that year.
13
happened that year, as we did inspect every seafood plant for
14
HACCP in the calendar year as we promised that we would.
But we do have things that
The good news is that a full 1,200-plus firms got
15
16
it fully right the first time.
17
unregulated in the past, that is an important step forward.
18
The bad news is we still have a long way to go.
19
educational letters with our untitled letters to industry.
20
We are following up with warning letters of enforcement where
21
that is needed.
We are providing
We also are putting what I call a booster shot of
22
23
For an industry that was largely
education.
So -- but Seafood HACCP round one is finished; round
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two is just as important, if not more.
2
practices:
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book.
Good agricultural
You have in your package in front of you a green
This is a very significant effort in the first year.
4
If you think back to the earlier telecast, somebody
5
asked the question, Are you going to get the industry involved
6
early on?
7
was a decree shortly before I took over first of the fiscal
8
year that we would do these good agricultural practices.
And this is a perfect example of that, because there
So the FDA quickly ran around, put together a working
9
10
draft.
The people who did it were very pleased with it, put
11
it out, and had grass-roots meetings.
12
got creamed.
I have to tell you, we
We were harshly criticized for not really being in
13
14
touch with agricultural practices.
And we then took that,
15
rounded more people -- got in more people from the agricultural
16
community, more from the states, more from USDA.
17
By the time we came up with our draft, the discussion
18
had shifted from whether to do it to, Are we doing exactly right?
19
We then went on with site visits and came out with a final
20
guide.
Within 12 months, it was endorsed by United Fresh Fruits
21
and Vegetables.
22
of speed and intensity, as well as involvement.
23
a start.
So we feel that is a good model, both in terms
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But it is only
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So we have a die.
1
That's nice if anybody's using
2
it.
I'll come up to that in Round 2.
But at least in the first
3
year, we did what we said we would.
We had a proposal where
4
we would extend HACCP for unpasteurized juice for juice
5
products.
6
fall apple season that has been in place since last September.
7
The president of the United States himself announced
8
that in the Fourth of July radio address, and that was really
9
clearly one of the highlights of the year.
And we put in place a label warning in time for the
But it's a highlight,
10
not just because he announced it.
11
it's giving consumers the important information they need to
12
protect themselves.
13
so much of a problem, but for vulnerable populations, a big
14
problem.
15
important.
18
You have a product that is largely not
We have those warnings in place.
And I think that's
Egg safety, we've got a start on.
16
17
It's a highlight because
notice with the USDA.
We issued a joint
We have a long way to go on egg safety.
We also -- kind of a sleeper area is the antimicrobial
19
resistance.
That is really a focus of another sector.
20
Center for Veterinary Medicine has the lead on that, but we
21
have put in place again as part of the broader surveillance
22
system, a surveillance system for resistance to antibiotics
23
used in animals.
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Our
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And we issued a progress report at the end of the
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2
year, which is available on our web.
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terms of the first year, we made a good start.
4
a start.
5
looking at, What do we feel the highest risk area is?
6
one is imports.
7
So at least we feel, in
But it is only
Where are we trying to go this year?
Well, we're
Number
The level of imports has skyrocketed over the last
8
five years, and the level of FDA coverage FDA has been able
9
to provide has lowered, and that is a bad combination.
And
10
so with the money we got from Congress last year, we are
11
strengthening both our emphasis to borders who are also
12
realizing we've got to have a stronger border presence.
13
increasing our inspections overseas.
14
We're
We're increasing our technical assistance to foreign
15
governments.
16
America, in overseas further.
17
conference out of Washington on rolling out and implementing
18
these produce guides overseas.
19
at that meeting.
20
We're using a variety of mechanisms in Latin
We just this week held a national
We had over 140 representatives
And so there was a lot of input there.
Number two, that leads me into the roll-out of the
21
good agricultural practices.
We work closely with USDA.
22
working jointly so that -- because they have the extension
23
service here.
They have the lead domestically.
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We're
We get the
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lead internationally.
We made -- sponsored the conference in
2
Orlando two weeks ago.
Domestically, we did the international
3
conference in Washington this week.
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its way.
5
6
Seafood HACCP-Round 2:
And so that is well on
I alluded to this already.
We are going back this year and we will be less patient.
We
7
are going to be providing more education along the way.
8
also -- we're saying we're going to get serious.
9
letters have already started to go out and if we need to take
10
enforcement, we will do that, because we need to get that entire
11
industry up to snuff.
12
Juice HACCP:
We're
Warning
We have to go forward with a final
13
rule on that.
14
out starting to address the issue of Salmonella in eggs, focusing
15
on retail, refrigeration and on consumer safe-handling
16
practices following on a transportation regulation that USDA
17
issued last year.
18
We have a proposed rule getting ready to come
And we have a broad number of issues under the
19
umbrella of the President's Council for Food Safety involving,
20
as the Commissioner said, in moderate term strategic plan and
21
coordinated budget, a better -- and even better coordinated
22
research across the government.
23
we have made a good start.
So I think in food safety,
We have to realize this is going
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to be a multi-year effort and is really challenging us in very
2
many ways.
I think, if you will, the good part of it is that,
3
4
number one, we are recognizing -- I think more people are
5
recognizing more and more this is a real problem.
6
problem because of some of the things Dr. Henney mentioned.
7
We have a change in the food supply.
8
distribution practices.
It is a real
We have different
We are eating at different places.
9
We're actually -- believe it or not, 50 percent of
10
the dollars Americans spend are on food prepared outside the
11
home.
12
We also have an increasing vulnerable population.
13
the very young, the elderly, the immune-suppressed, pregnant
14
women, that's almost 25 percent of the U.S. population.
And so the retail food service is an important area.
Think about it.
15
If you take
Twenty-five percent are at high
16
risk.
17
and makes the issue more compelling.
18
is more compelling -- is so compelling is making us break down
19
a lot of barriers that did exist in the past.
20
like me at the FDA are now talking about reducing foodborne
21
illness, not just about:
22
the product?
23
This is not a small amount.
It is a very high amount
The fact that the issue
And so people
Are we getting good regulations on
We have a recent MOU that we've signed with the Food
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Safety and Inspection Service at USDA in plants of joint
2
jurisdiction.
We have closely worked with CDC.
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better?
Can we do more with the states?
4
But the issue is sufficiently compelling.
5
6
Yes.
Can we do
Yes, also.
We're seeing that.
And the good news is that people are rising to the occasion
of what is needed.
But we move on.
7
Priority setting:
I've already
8
told you the top three priorities.
9
responsibility over a lot of other aspects of the food supply
10
and the food regulation.
11
Okay.
12
safety.
13
simple basic questions.
We also have a
And so what I said last year was,
After we take care -- we at least get
going on food
We even looked across the foods program and asked the
We can't do everything that Dr. Henney said.
14
Where
15
we do most good to consumers, that's where I'm going to direct
16
that our time be devoted.
17
an open and participatory priority-setting process for the year
18
we're in now and to develop a blueprint for our foods program.
19
We have established as always having
Again, it's what I said last spring.
We held a stakeholder meeting.
20
This was the birth
21
of the FDA stakeholder meeting that the Commissioner mentioned
22
in June.
23
presentations.
We had -- you see a number of oral written
It was at that meeting that I first showed this
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chart.
And I'll dwell -- pause on this for a moment.
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worked for FDA for 20 years.
So I've
I took a job as director of CFSAN.
I consider myself knowledgeable enough that I knew
3
4
something what I was getting into.
But I was
5
surprised -- genuinely surprised when I saw this chart.
6
Center for Food Safety, if you go back 20 years, which isn't
7
just the day I started and it isn't just 20 years as a round
8
number -- it also, in fairness, is the peak of the foods program.
9
This is the year that the Food Center had the most
10
people.
It was just under 1,000 -- 995.
11
clearly is ten years of constant reductions.
12
among a lot of agencies across government.
13
'90s start to get better.
14
was in the seafood area.
15
seafood.
The
Now, what you see
That is common
You see now early
Almost all of that getting better
There was a lot of visibility on
16
We had some small increases for imports, as well
17
as some small increase for our nutrition labeling, somewhat
18
after the fact, and some very recent at FSI that doesn't really
19
show up here because it was the first year.
20
with those increases, we still are 200 people below where we
21
were 20 years ago.
But you see even
22
Now, another way to look at it if you worked in the
23
Center, if you take away those added targeted resources -- that
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they were mostly for seafood, but also some for imports and
2
nutrition labeling and the first little wave of food
3
safety -- we're down a full 33 percent.
4
people -- or at least a lot of people that work in CFSAN -- number
5
one, they've been there 20 years, because the last big hiring
6
binge in foods in FDA was the 1970s, following the Bon Vivant
7
incident -- those with good memories.
And most of the
8
Number one, they've been there.
They look around.
9
They know how many were in their branch.
But I went around
10
around from office to office.
11
turn, she filled out a sign -- held up a sign that said, Small
12
but mighty, proud but poor; my division could sure use a lot
13
more.
14
One person, when it got to her
And I actually took that.
I framed it.
Dr. Henney took it recently across to show the
15
secretary, because it reflects, unfortunately, a lot of what
16
is going on across FDA.
17
there are a number of programs in FDA that are getting very
18
well funded:
19
mammography program.
20
food safety program.
As Linda Suydam said on the tape before,
the prescription drug user fee program, the
Now we're starting to get there with the
21
But when you look at all the other programs, they're
22
the ones that are really getting squeezed, and this shows it
23
very graphically.
At the same time, of course, Congress passed
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all these laws adding new responsibilities.
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director; I look at these charts, and I say, Wow.
3
to set priorities.
And so we did.
4
5
I'm the new center
We have got
We then tried an internal process.
Each program presented what they thought priorities should
6
be.
We did cross-cutting priorities.
We shipped aside
7
traditional comprehensive plans.
8
as we were finishing up that.
9
overlapped strongly with foods, and we wrapped those in, and
The Commissioner joined us
We took her priorities, which
10
we came out in January with this CFSAN priorities document.
11
Internally, we call this the bible, because this
12
is not just our work plan; this is what we are doing this year
13
and what we are committed to finishing.
14
looking at it is, number one, food safety covers about 50 percent
15
of our priorities.
16
What you find from
It's also now about 50 percent of the Center's
17
resources are devoted to food safety initiative work, which
18
is a translation for anything related to microbiological
19
contamination falls under that general umbrella.
20
And so I will not go through those since you have
21
it all in front of you, but we have specific objectives that
22
we will accomplish in imports and HACCP and produce and
23
additional prevention efforts, in surveillance and outbreak
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response research, risk assessment, and education, to continue
2
a growing emphasis in this area.
Number two, you'll find we identify five other
3
4
program areas that need emphasis:
premarket review of food
5
ingredients, nutrition, health claims and labeling, dietary
6
supplements -- and one of the speakers is going to be addressing
7
that after me, an area of growing interest -- chemical and other
8
contaminants.
9
I'll tell you, if you looked at this same slide from
10
a previous director a decade ago, you would see it reversed.
11
You would see chemical contaminants way up there high and
12
microbiological problems much lower in priority.
13
a real reversal in that.
14
problems.
15
readdressing a number of the chemical issues, as well, and
16
finally cosmetics.
17
shrinking of the science base; increasing federal, state, local
18
collaboration; establishing what I'd call an affirmative
19
international agenda.
20
codexed in other areas.
21
We've seen
That's good for the microbiological
At some point, we're going to have to start
We also have cross-cutting areas and
There are lots of international meetings
I want to be sure that not only are we prioritizing
22
where and how we go, but we go with a mission to accomplish
23
something positive for American consumers.
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I think Linda
22
1
Suydam said, We see harmonization as an opportunity to be world
2
leaders.
And we want to be there.
But to do that, we have to think about it.
3
We can't
4
just get an agenda to a meeting, go there and come up with a
5
position, you know, immediately prior to that.
6
to spend more attention internally to the resources.
7
all the specifics on here.
8
look at it.
9
item to just very clearly say, This is what we're going to try
10
You have
Again, I ask you to take it and
You will find simple one-line listings of each
to do.
We also have what I call the A list and the B list.
11
12
And we have
The A list means we will do it.
It doesn't mean we're going
13
to try to do it.
14
those.
15
and the boulder.
16
thought that FDA makes the mistake of spreading ourselves too
17
thin.
18
We're going to do it.
And there are 79 of
I am well known for telling my story about the pebbles
And what it basically means is I've always
And I think it likes taking 100 pebbles, pushing
19
them up a mountainside one mile an hour.
20
have you got?
21
identify a fewer number of boulders, get them up and over the
22
hill; show the consumer we are something -- you know, the
23
taxpayer has gotten something.
A mountainside of rubble.
After 50 years, what
And I would rather
There was something to show
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1
for ourselves and some real accomplishments.
2
Even though we've whittled this list down and down
3
and down and down and down, we still came up with 79 boulders.
4
And people are challenging me on whether my pebble/boulder
5
theory works.
6
so I think we're in the right direction.
7
challenge, but it's something I'm gladly taking on, because
8
I believe if we focus on specific things, we can do them and
9
we will.
10
And I said, Well, we started with a thousand,
It is a management
The B list means not the opposite, but a
11
separate -- these are things we know they're important.
12
want to make progress on them.
13
on the A list.
14
other and not get done.
15
progress on as we can.
16
We
I would love to see them all
But with them all, they will neutralize each
So these are the ones we will make
We are monitoring very clearly all the boulders,
17
and I promise to have four-month reviews and modifications as
18
new things happen during the year.
19
up at the end of this month.
20
Accomplishments:
And the first one is coming
I noted earlier I don't believe
21
that in jobs such as ours it's enough to have nice plans.
22
important to have nice plans, but they really don't mean a lot
23
unless you have real accomplishments that we're doing.
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It's
I am
24
1
going to run through these ever so quickly.
2
slides are on our website, so you can access them and go back
3
and look at them.
But just to note:
4
The copies of these
In addition to food safety that
5
I mentioned, in food additives, we approved last year two new
6
artificial sweeteners, did a postmark review of Olestra,
7
approved a new food additive, chlorine dioxide.
8
of that that was one of the stimulants to focus on creating
9
expedited review for food-safety related petitions.
And because
10
And so we have a new program now that says if you
11
in the industry have a new chemical, have a new process that's
12
going to make the food safer, that's going to kill pathogens,
13
we are not going to put that on the routine track; we're going
14
to move that to the front of the line.
15
incentive for companies to invest in these products.
16
want FDA to be the logjam for that.
17
place now.
18
We want to create an
We don't
And that has been put in
In the area of health claims and food labeling, you
19
can read them up there.
We are having a public meeting in May
20
11 to look at the issue of authoritative statements.
21
a somewhat controversial area.
22
psyllium we said yes to; soy protein, we said yes to.
23
nine notifications, we said no to.
It is
You'll see amongst up here
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The first
25
1
And our pledge is to work on the basis of science
2
and openness.
3
that people understand and is consistent with the law.
4
so we're having a meeting to try and address that.
5
But we also want to be sure we have a process
Dietary supplements:
And
We issued a structure
6
function proposed rule last year -- very controversial -- a
7
lot of comments and questions about that.
8
9
We issued a proposed rule extending to dietary
supplements, the same provisions of FDAMA that apply to
10
conventional foods on authoritative statements.
11
coming in place -- and this was referenced earlier very quickly.
12
Just like the food nutrition panel, we have now the same kind
13
of panel focus on supplements that became effective this past
14
month for dietary supplements.
15
It's called supplement facts.
And we have
It gives very clear
16
information on what's in there:
17
acids, herbs.
18
if it's from the leaf, if it's from the stem.
19
daily reference value, it gives you the percent.
20
same format you're used to seeing on the food label.
21
that it's focus is what I call the bottom half of the label
22
instead of the top half of the label.
23
vitamins, minerals, amino
Within herbs, it tells you if it's from the root,
If there's a
It's in the
It's just
In foods, I think most people look at fat, saturated
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1
fat, sodium, cholesterol, fiber and so forth.
2
in dietary supplements more on the vitamin, mineral, amino acid,
3
botanical section.
4
now.
But that is coming out.
This is focusing
That is effective
And consumers will start to see that on shelves.
Federal-state collaboration, an increasingly
5
6
important area:
7
such, as I meant before, that nobody can do it ourselves
8
individually.
9
10
The scope of the Food Safety Initiative, as
And we're devoting major efforts in this area.
Number one, we have come out with the latest -- really first
real and widely endorsed provision of the Food Code.
11
As I mentioned before, if 50 percent of our dollars
12
are spent on food prepared outside the home, and a lot of those
13
foods prepared outside the home are institutions that deal with
14
individuals at high risk of foodborne illness -- nursing homes,
15
hospitals, day care centers -- then the Food Code really becomes
16
a very important vehicle.
Secretary Shalala, Secretary Glickman have written
17
18
to all 50 governors.
19
in feedback from our state colleagues here -- increased
20
receptivity in the states.
21
effort.
22
integration meetings.
23
We are seeing -- and I'd be interested
But that will clearly be a major
We have sponsored a series of what we call national
We have representatives from all states -- state
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1
health departments, Ag departments, FDA, USDA, CDC, state
2
epidemiologists -- Janice Oliver referenced that -- focusing
3
first on outbreak response, laboratory capabilities and
4
findings and techniques, and finally on inspections.
5
very closely with the ISSC on the specific issue in shellfish
6
safety in the state of Florida.
7
more about that, we can address that in the question and answer
8
period.
Budget:
9
We work
And if people want to know
Let me focus a little bit on the budget.
10
Let me give the usual caveats, which is that federal officials,
11
including myself, are not permitted to either lobby individuals
12
or ask people to lobby on their behalf.
13
trying to desiring to do that.
And I clearly am not
What I have found, however, is people just surely
14
15
do not understand our budget.
16
FDA don't understand our budget.
17
both inside and outside, to just lay out -- What is it?
18
is the budget?
19
I'll tell you most people in
What has it been?
What does it mean?
And we have found it valuable,
What is our budget request?
What do we get this year?
And I will try to do that quickly for you.
20
What
FY '99 budget increases for all of FDA.
Number
21
one:
22
perception that the food sector of FDA does not get sufficient
23
interest when it comes to funding.
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There is a wide
28
There may be some historical basis for that, but
1
2
that is being turned around under the auspices of the Food Safety
3
Initiative.
4
of the money given to FDA as an addition in FY '99 was for the
5
foods program.
You see here just from last year virtually all
Number two, with the Food Safety Initiative $25
6
7
million, we devoted about 14 to the field, nine million to the
8
Center, a small piece, 1.3 million, to veterinary medicine for
9
antimicrobial resistance and a half million to NCTR, our
10
Arkansas research facility, for research.
The allocation was
11
done this way because the purpose of the money was to really
12
devote on imports and on produce, and a lot of that is done
13
in the field with headquarter's help and direction.
We also got a number of very small but targeted
14
15
increases for cosmetics, for food contact substances and for
16
seafood, which was to be devoted to equivalency assessments
17
with border countries.
18
is part 2 to the same chart you saw before.
19
impact -- certainly, the last chart looked good.
Now, let's see.
I'll go back.
This
Let's see what
20
We see the good news is for the first time in a number
21
of years the FTE Base within my Center has increased, and that's
22
very good.
23
essential to the food safety effort.
And we are devoting it to those programs that are
And so we're starting
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1
to get that.
Even so, we're still, of course, a long ways away
2
from 1978 laws.
But remember the second chart I showed.
3
If you're
4
a part of the base program, non-Food Safety Initiative part
5
of the Center, you took an additional cut.
6
happened within FDA each year now is that -- and this has been
7
so for about the last five years -- we need to absorb
8
inflationary increases.
Because what
And so if the base program gets the same amount of
9
10
money as the year before, we can't sustain the same program
11
the year before, because costs have increased.
12
cost increase; other costs increase.
13
replace people, because we need what would have gone to their
14
salaries to make up for that shortfall.
15
happening for about five years in a row at the FDA.
The payroll
And so we need to not
And this has been
And so you see, even with those increases, the base
16
17
program is going down.
18
restoration, which I put it here because that was part of the
19
base program, it would have gone down even further.
20
this is very important to understand as we are allocating
21
resources.
22
where the biggest problems are in the area of food safety.
23
And were it not for that cosmetics
And so
The good news is that the new money is going to
The not-so-good news is that the base program, as
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1
Linda Suydam says, is being eroded.
2
I know to try and illustrate what the facts are there.
3
And this is the best chart
2000 budget, looking ahead:
Because of that -- I
4
just want to come back for one second there.
5
not unique to foods.
6
about foods.
7
worked in all parts of FDA.
8
9
This chart is
I know we're here; I'm supposed to talk
But I'll take advantage of the fact that I've
And it is certainly true in the field.
You ask
anybody here in the Chicago district or Detroit district.
10
People realize that the base programs across have been eroded.
11
And we all got together last spring and all the center directors
12
realized we have issues, say, more common than you think.
13
There's nothing like a common problem that can band
14
people together, whether you're in food or drugs or devices.
15
And we realized that we need to seriously address that.
And
16
so this year for the 2000 budget, which is what is before the
17
Congress -- we had our Senate hearing yesterday -- FDA -- the
18
president has proposed a $216 million increase for FDA above
19
last year's appropriation.
20
That's an 18 percent increase.
If enacted, it would be the largest one-year
21
increase, at least any of us can remember.
The Secretary
22
Shalala is getting directly involved.
23
Appropriations Committee in February, "The president's budget
She wrote the Health
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1
request for FDA for FY 2000 begins a fundamental rebuilding
2
of this agency and its science base."
3
I would focus on a number of things, starting with
4
"fundamental," but also focusing on "begins." I think Linda
5
Suydam used the phrase "downpayment" in terms of strengthening
6
the Agency and its science base.
7
Now, let's see where those monies are put.
There
8
was a question on the telecast about injury reporting and adverse
9
event reporting.
10
There's 15 million there.
I'll show you later where the food pieces are in
11
all of this.
Product safety assurance:
Most of that is for
12
drug and device inspections; there's also money for an L.A.
13
lab within there; premarket approval across a number of areas;
14
Food Safety Initiative is a separate line item; tobacco and
15
bioterrorism.
16
Now, coming to food and back about Secretary Shalala,
17
food safety is a compelling public health issue and is a critical
18
responsibility of my Department.
19
reduce a persistent hazard.
20
in view of what is needed.
21
FDA to the food program?
22
foods program.
23
The requested new funds will
And so we are clearly very much
Now, how is this translating to
Again, the full 30 would go to the
Within food and color additives, that was approved
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1
on the review section.
There was 11.4 million, most of which
2
would be in review fees.
I'm going to come back to that.
3
reporting is a two-and-a-half million dollar piece.
4
that would go to dietary supplements, food ingredients and
5
cosmetics.
6
College Park in two years.
Injury
Most of
We are moving to a new modernized facility in
That is very good.
We need to start getting the basic funding.
7
8
Construction has been funded, but there are moving costs.
9
we're starting to request both funds this year.
And
This money,
10
by the way, will just wire the new building.
It is important
11
to have the building wired, obviously, and that's what that
12
money is for.
But is all that money would cover.
We also have a proposed transfer of a seafood
13
14
inspection program from Department of Commerce to the FDA.
15
That is also a fee for service program, and that would be a
16
transfer.
17
areas are off $64.2 million.
18
bit, what would we do with the money?
19
But total affirmative increase of FDA in the foods
Now, breaking that down a little
You've heard me stress I believe in results.
In
20
terms of inspection capability, we want to be able to inspect
21
once a year all of the facilities that have food that we believe
22
is at high risk of microbiological contamination.
23
about 6,200 such firms nationwide.
There are
That includes seafood.
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We will more than double our foreign inspections.
2
And we also have to devote money to the necessary
3
research and so forth to give our inspectors the right tools
4
to do the job.
5
methods that inspectors can use to really detect food safety
6
issues.
We need better rapid tests.
Outbreak response:
7
8
we have a better system.
9
more things.
We need other
The good news on surveillance;
The bad news is it's going to detect
And we have to be available and ready.
Probably
10
one of, I think, the few mistakes I've seen in the food safety
11
funding is outbreak response was never budgeted in the first
12
two years.
13
tell you from the field -- if it happens, we will do it.
14
if we do it, it comes off the top, but it works -- it cuts into
15
the time that otherwise could have been spent on inspections.
16
So we have to realize we have a better surveillance
And I can tell you -- and I'm sure Ray Mlecko would
17
system.
18
the resources to have the kind of rapid response teams to develop
19
them.
20
the hook-ups to the PulseNet system.
21
It's going to reveal more outbreaks.
And
We have to have the life support.
We have to have
We have to increase
We also have to focus more on retail and food
22
service -- training in the Food Code -- you've heard me talk
23
about that -- antimicrobial resistance contained in the
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surveillance there.
2
in these areas.
3
Injury reporting:
Food additives:
As I said, 2.5 million
I'll pause it here a moment.
There's 1.4 million in appropriated funds.
4
related feed-based requests.
5
substances.
There are two
One is for food contact
This is actually a provision in FDAMA.
6
These are
7
the so-called indirect additives, something used in the
8
packaging that might leach into the food.
9
request there.
There is a $6 million
There is also -- and that would essentially
10
fully fund that program.
There also is a $4 million request
11
for direct food and color additives.
12
to the funding of that program.
That would be a beginning
13
Both of those will be based on a successful model
14
of having fees that are dedicated to the task, clear performance
15
goals, and accountability all around.
16
last year.
17
to be identifying real public health issues and be sure they
18
are being addressed properly.
19
safety and food safety is our top priority.
20
So here's a slide I used
The challenge is still there.
Number one, we have
That's why food safety, food
Number two, we have to establish clear priorities
21
and stick to them.
We've established priorities.
We have to
22
stick to them.
23
now that want me to do this, that, or the other thing.
I will tell you I meet with people frequently
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And
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1
I have this book out and I say, Show me something on here that
2
is more important than.
We have to realize, as Dr. Henney said, that we cannot
3
4
do everything.
I'd rather do something well than everything
5
poorly.
6
will support me in trying to stick to them.
7
our best way of matching expectations with resource availability
8
and finally enhancing a two-way communication with
9
stakeholders.
We have to be able to stick to them.
To me, that is
In that connection, we have established a website
10
11
within the Center that is very popular.
12
a new information center.
13
stakeholder meetings.
14
stakeholder meetings Mark Barnett set.
15
event.
16
I hope you folks
We are establishing
We have special mailings,
On here, just a listing of the food
Today is not an isolated
In addition to the one that I talked about last
17
summer, we had one on cosmetics to deal with the restoration,
18
one on an international scheduling issue, one on food contact
19
substances, today's; I referenced the one on health claims,
20
and finally, we are scheduling one on dietary supplements.
21
So that's very important.
22
23
In conclusion, last spring I just took the job.
I saw the excitement, the challenge.
I said to everybody, It
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1
really is -- I mean it -- a great time to be in the foods
2
business.
3
time to be in the foods business, but it's getting better all
4
the time.
5
a real recognition of the problems.
A year later, I say not only is it still a great
And it's getting better because, I think, there is
6
People are coming together to solve those problems
7
and we're doing something valuable and critical for the American
8
consumer.
9
again, our job is just beginning.
I'm delighted to be a part of that, but we know,
Thank you very much for your
10
attention to a talk that was probably a little too long.
11
thank you very much.
12
I
We will have time later for questions.
What we're going to do now is Dr. David Armstrong,
13
who is the research director at the Moffett Center down the
14
street, has a presentation which he promises you is shorter.
15
And then we have a number of public presentations, people who
16
came here prepared, wanting to give a presentation, also.
17
Please welcome Dr. Armstrong.
18
(Applause.)
19
DR. ARMSTRONG:
I might say while we're waiting that
20
I had no idea the Commissioner was going to mention the Moffett
21
Center, in spite of what Mr. Levitt thinks.
22
Center a few months ago.
23
She did visit our
She also visited the Chicago district.
And I guess she was quite impressed with our operation.
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I don't know if that's in focus.
1
This is a picture
2
of the facility.
And it's located three miles west of Midway
3
Airport in Bedford Park.
4
Chicagoans may have gone by this facility and thought it was
5
part of the Corn Products Company, but it really isn't.
6
FDA part of this Center is located on the fourth floor here.
And I'm sure those of you who are
The
What is the National Center for Food Safety and
7
8
Technology?
It began about ten years ago as the Cooperative
9
Research Consortium.
And it was really, in my view, one of
10
the first attempts -- first modern attempts of FDAMA by FDA
11
in that we instigated to enhance FDA's food science expertise,
12
expand the FDA's food science research program, cope with
13
emerging food production, processing and packaging technology
14
and enhance FDA's scientific communication with industry.
15
Our goals were that we were the open lines of
16
communications with our stakeholders.
17
scientific and technical exchange among diverse segments of
18
the food science community.
19
to understand the science and engineering behind food safety.
20
And we needed to conduct much more research promoting the safety
21
We wanted to foster and
We recognized we better needed
and quality of the U.S. food supply.
22
And this is where we get into the concept of being
23
a proactive Center within FDA in that once a food safety problem
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appears, we take the initiative.
2
my diversity as far as multimedia and flip over to the
3
transparency.
4
(Pause.)
5
DR. ARMSTRONG:
And now I'm going to show
I'm going to kill all my time with
6
audio visuals.
7
Intervention Program research program for FDA.
8
I said, it's really a proactive approach to FDA's mission to
9
ensure food safety.
10
11
At the National Center is the Prevention and
And I -- as
Actually, we've had a long history in this
program of responding to acknowledged food safety issues.
And we've done many collaborative projects and task
12
forces in the past.
13
president's Food Safety Initiative.
14
stakeholders we have involved at the National Center, we have,
15
of course, CFSAN in Washington, who we are a part of.
16
the National Center for Food Safety and Technology, which
17
consists also of Illinois Institute of Technology, University
18
of Illinois and also industry.
19
Currently, we are responding to the
As an example of the
We have CFSAN-Dauphin Island.
We have
And then we have our
20
various collaborations with USDA, particularly ARS.
21
several universities that we do contract research with.
22
collaborate with the U.S. Army/Navy laboratories.
23
we're beginning to collaborate with JIFSAN, our sister
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We have
We
And now
39
1
organization back in Washington.
As well, we have extramural
2
grants that CFSAN has given in this program.
Actually, we do three parts in this Prevention and
3
4
Intervention Program.
We do what's called a hazard reduction
5
assessment.
6
reduction that FDA is proposing for the juice regulation.
7
we look at technologies to see if they're capable of actually
8
doing a five-log reduction.
And some of you have heard about the five-log
Here
Besides that, we need to look at the critical control
9
10
points in the process to assure us that we can measure that
11
this reduction is being achieved.
12
is technology validation.
13
process that assures us that this reduction is achieved and
14
can -- more importantly, can we deliver every time?
The next part of the program
What is it that we measure in the
15
So do we have a valid technology that we can trust?
16
And finally there, the par-market approval considerations for
17
the technology -- during the process of doing this new
18
technology, are there substances generated that might be fruit
19
safety problems in themselves?
20
today some examples of the research that we're doing out at
21
the National Center for Food Safety and Technology.
Number one, we're working on particularly alfalfa
22
23
I just wanted to give you here
sprouts.
Number two, we're working in the safety and assurance
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1
of unpasteurized juices.
Three, we're working on the control
2
of pathogenic organisms in seafood and four, on the survival
3
of pathogens during the 60-day aging period for hard cheeses.
I might mention that this has recently been
4
5
challenged because of some outbreaks that have occurred with
6
hard cheeses from unpasteurized milk.
7
this -- unpasteurized milk and not pasteurized milk.
8
at the Moffett Center, we have a what we call pathogen pilot
9
plant.
And I should emphasize
Currently
It's biocontainment pilot plant where we can
10
11
actually inoculate E-Coli 015787, which is an organism some
12
of you have heard about, directly into cheese and follow its
13
growth in cheese.
14
in the United States.
15
the Center.
This is one of the few pathogen pilot plants
And we're just initiating that work at
16
I wanted to talk a little bit about another subject
17
I'm sure some of you have read about, and that is the risk from
18
sprouts.
19
Washington and California.
20
conditions really allow for pathogen growth.
21
most interesting part or the most exacerbating part is that
22
sprouts are consumed raw.
23
Recently, they've been linked to numerous outbreaks,
We have found that the sprouting
And probably the
There's no kill step involved.
What we have done at the National Center is to develop
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1
what we call a sprout task force.
And we got together all the
2
industry, the academia, USDA, other governmental agencies, if
3
they were involved, and sit down with them and try to determine
4
what we could do in terms of research to address this food safety
5
problem.
And the research approach that we came up with was
6
7
first, we're going to try to assess thermal, chemical,
8
irradiation and other treatments that we might do for pathogen
9
inactivation in seeds.
Next, we're going to try to conduct
10
some commercial scale process evaluation in our biocontainment
11
pilot plant.
12
And finally, we're going to try to develop a rapid
13
test method to detect pathogens in the sprout irrigation water.
14
I don't know if many of you are familiar with the sprout-growing
15
process, but these sprouts are grown in huge rotating drums.
16
And generally, they grow -- you start with about 40 pounds
17
of seeds which turns into about 800 pounds of sprouts.
But in the process, that takes from four to seven
18
19
days.
These -- this time period is an ideal incubation period
20
for both microorganisms and pathogens.
21
methods where we could, at the end of two or three days, test
22
this irrigation water that's constantly being sprayed on these
23
sprouts to determine if pathogens would exist in that water.
So we're looking at
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Therefore, the sprouters could make a determination
1
2
at that time whether the sprouts were safe to distribute.
3
Finally, I want to talk about who benefits from this approach.
4
First off, the sprout growers benefit because in general, these
5
are small -- very small companies, if you want to call them
6
companies.
7
operations where they're growing sprouts.
And they do not have a lot of money to do the needed
8
9
They're usually individuals that have garage
research in this area.
So if we're going to have a sprout
10
industry, much research needs to be done for prevention.
For
11
CFSAN, we can look at the guidance for HACCP and GMP
12
implementation that we need to provide and we also need, perhaps,
13
to incorporate into our regulatory programs.
Finally, when this all distills out, we need to
14
15
provide guidance to the FDA field operations.
16
by saying that research is fine.
17
published -- and all of our research is published and we have
18
great scientists, both in Washington and at the Center.
19
the most important part, I think, is the technology transfer
20
part of it.
21
And let me finish
And that if it's
But
We need to get this technology out to the people
22
who use it and out to the people who inspect it.
23
my song and dance for today.
And so that's
Thank you very much.
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MR. LEVITT:
1
We now have three speakers that have
2
asked to address us today.
Before I announce them, I'm
3
wondering if it would be well for everybody to stand up for
4
just one minute in our places and take a stretch.
5
have realized you were coming to a double-header here.
You may not
If I could have everybody's attention, please.
6
We
7
have, as I mentioned, three people who have asked to make a
8
short presentation.
9
we're not sure if the third one will be available.
Actually, two of them are here, and so
If not,
10
we'll be happy to take their presentation and add it to the
11
record of the proceedings.
12
But let me begin by introducing Joseph Doss, who
13
is the senior vice president and director of public affairs
14
at the Consumer Health Care Product Association.
15
going ask for each speaker to try to limit yourself to about
16
ten minutes.
MR. DOSS:
17
18
Thank you very much.
And we're
I will be brief.
I want to first thank Joe Levitt for the opportunity to be
19
here.
The Consumer Health Care Products Association thinks
20
that this is a very important forum to encourage a dialog and
21
sharing of information.
22
to the industry.
23
to the consumer.
It's helpful to FDA.
It's helpful
And I think ultimately, it will be helpful
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1
We have had participants at not only this location,
2
but as you saw, we had someone in the Washington meeting, as
3
well as the Philadelphia meeting.
4
important, and we try to participate whenever possible.
5
those of you who may not know, the Consumer Health Care Products
6
Association represents manufacturers of non-prescription
7
medicines, as well as dietary supplements.
8
9
So we think these are very
It's a relatively new name.
1881 -- over 118 years.
For
We've been around since
But with our new name, we've only been
10
around for about a month and a half.
11
we were formerly known as the Non-Prescription Drug
12
Manufacturers Association.
13
200 companies involved in the manufacture and distribution of
14
consumer health care products, primarily OTCs and dietary
15
supplements.
16
It's a new name.
And
And we basically now represent over
My comments today will be just directed to dietary
17
supplements.
18
Agency's and CFSAN's objective of developing an overall strategy
19
for dietary supplements, which is listed in that bible that
20
Joe mentioned earlier, I think on page 10.
21
offer a few thoughts on how the Agency might want to go about
22
for developing this overall strategy.
23
And I first want to say that we agree with the
And we'd like to
We were first very interested in the Agency and CFSAN
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1
statement that they are seeking to set boundaries between a
2
dietary supplement and a conventional food, between a dietary
3
supplement and a drug and between a dietary supplement and a
4
cosmetic.
5
And I just wanted to bring up the issue of -- as
6
we've looked at that sort of terminology, boundaries, I wanted
7
to talk a little bit about that, because we think that in some
8
cases, some people might have a sense that that's a pejorative
9
term, in the sense that it seems rather limiting and doesn't
10
seem to acknowledge that some of these could be more than -- fall
11
into more than one category.
12
It may not have been the intent, but it was just
13
sort of a reaction that some of our members had as they heard
14
the word, boundaries.
15
and would hope that as we move forward and discuss this that
16
we start thinking about what dietary supplements are, rather
17
than what they are not.
18
So we think terminology is important
And if strict boundaries were to be set for
19
particular classes of products, we think that it might have
20
a tendency to box out other product classes.
21
it's obvious that there are certain examples of where products
22
fall under more than one classes.
23
instance, are both -- they have health claims for osteoporosis,
And, you know,
Calcium products, for
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1
as well as making drug claims.
There are also psyllium products which are both
2
3
dietary supplements and OTC drugs.
As we're getting away from
4
dietary supplements, you have the traditional antiperspirant
5
deodorants which are categorized as cosmetics as well as OTC
6
drugs.
7
containing pesticides regulated by EPA.
And there are certain OTC drugs which are also
8
So it's sort of -- there can be an overlap of product
9
category, and we just wanted to begin thinking about that and
10
to make sure that there was no unintentional sort of activity
11
that might exceed the current boundaries of DSHA [phonetic],
12
and just wanted to have the opportunity as the Agency moved
13
forward to talk to them about that and engage in a dialog on
14
that.
Also mentioned in CFSAN's priority A list are dietary
15
16
supplement good manufacturing practices and adverse even
17
reporting.
18
Association, as well as the rest of the dietary supplement
19
industry, have supported establishing GMPs for dietary
20
supplements.
21
As for the GMPs, the Consumer Health Care Products
We have submitted comments to FDA.
We're continuing
22
to look at it and hope to further discuss it with the Agency
23
as they move forward with the issue.
On AERs, adverse event
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1
2
reporting, we heard a little bit of discussion about that today.
As we go forward and we look at this issue for dietary
3
supplements with regard to AERs, we wanted the Agency, and CFSAN
4
particularly, to be aware of a couple of our thoughts.
5
And first of all, one is that there are currently
6
several sources of information that are available to obtain
7
dietary supplement adverse event reporting information.
8
You've got Med Watch, Dawn [phonetic], spontaneous reports from
9
consumers, the toxic exposure surveillance at the Poison Control
10
Center, the published literature and other sources, as well.
11
12
So it's important to take a look at that.
Also, let's talk about the website and putting up
13
of adverse event reports on the website.
Clearly, the web is
14
an important tool to get information out to consumers.
15
we have some reservations about, I guess, the way it's currently
16
being done in terms of putting things up there that might not
17
have had the proper filter to make sure that they're accurate
18
reports about a specific scientific concern.
However,
19
And in keeping with the thought of today in trying
20
to get input from groups like ours, we think that it's important
21
to think about the kind of approach that would allow the
22
education of the public about the concept of balancing the risks
23
and the benefits, but without unnecessarily alarming them,
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1
because it might not have been an accurate report or you just
2
don't know what the source was.
So we, again, welcome the opportunity to be a part
3
4
of that discussion.
As to the -- how the Agency can enhance
5
its outreach efforts, these are great meetings -- stakeholder
6
meetings.
7
mentioned that perhaps that the Agency should take a look -- or
8
CFSAN should take a look at having a meetings manual policies
9
and procedures.
Dr. Soller, who was at the Washington meeting,
I don't think you have one.
10
As Bill mentioned,
11
that's something that you might consider.
12
[phonetic] to develop that.
13
scheduling meetings and conducting the meetings with outside
14
groups.
15
after request for a meeting to be scheduled, the need for prompt
16
preparation and sharing of minutes from the meeting and for
17
a summary of the major points that take place during the
18
meetings.
19
We worked with CEDER
And it set forth procedures for
It describes, among other things, the maximum time
And we found them very successful and would encourage
20
such procedural documents be prepared within CFSAN.
21
I just want to thank Joe and Ray for the opportunity to be here
22
to share our thoughts, and look forward to working with the
23
Department, with the Center as they move forward.
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1
Also, just one procedural matter:
We'd hope that
2
maybe the record could be kept open for a week or so.
3
that you're going to be accepting more questions, but we may
4
have some follow-up process as a result of some of the things
5
that were said today.
Okay.
I know
Thank you very much.
6
MR. LEVITT:
7
Our next speaker is Ms. Karen Truskowski, multiple
8
9
10
Thank you.
chemical sensitivity health and environment.
She's here.
MS. TRUSKOWSKI:
I'm going to discuss the problems
11
with fragrances.
12
fragranced products in a day.
Many of these products are
13
applied directly to the skin.
The users of these products
14
assume the safety of the materials used in them and the final
15
product has been established.
16
people that this is not the case.
17
A person easily uses a dozen or more
It has never occurred to most
Fragranced products such perfumes, colognes and
18
personal care products come under the jurisdiction of the FDA.
19
However, due to the trade secret status of fragrances -- or
20
fragrance formulas, the fragrance industry is basically
21
self-regulated.
22
do not have to be disclosed to anyone, even the FDA.
23
The ingredients used in fragrance formulas
Increasingly, fragranced products are cited as
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1
triggering or causing health problems.
Though the industry
2
has in place procedures for establishing the safety of fragrance
3
materials, these measures are not adequate.
4
been slow to address the issues involved.
5
by the industry need closer examination.
The industry has
The answers provided
The industry says fragrance materials have a long
6
7
history of relatively safe use.
8
have been used for centuries.
9
1860s, virtually all fragrance materials were obtained from
10
plant and animal sources.
11
close to found in nature.
It is true that fragrances
However, until late the late
And the concentrations were pretty
12
No one chemical was found in isolation.
Companion
13
chemicals found together often had synergistic and modifying
14
effects.
15
synthesized from petroleum products.
16
nature.
17
are obtained from plant materials are often extracted as
18
isolates.
The majority of modern fragrances materials are
Many are not found in
There is no long history of use.
The material that
This means individual chemicals, rather than the
19
20
complex mixtures found in nature, are used.
History of use
21
of -- history of use no longer applies, as the action of
22
individual chemicals may be far different than in mixtures.
23
Okay.
Industry also says compounds are used at such low levels
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1
that they are not a health risk.
The current trend in fragrance formulation is toward
2
3
using powerful long-lasting synthetics at higher levels.
One
4
material may make up as much as 25 percent of the formula.
5
It is not unusual for four or five materials to make up 80 percent
6
of the formula.
Industry also says fragrance materials are safety
7
8
tested.
The Research Institute for Fragrance Materials safety
9
tests fragrance materials.
Only about 1,300 of the more than
10
5,000 materials used in fragrances have been tested for safety.
11
The testing that is done is generally limited to acute oral
12
and dermal toxicity, irritation and dermal sensitization and
13
phototoxicity.
14
Testing is limited to individual materials.
There
15
is little effort to address synergistic and modifying effects
16
of materials in combination through the -- though the IF -- RIFM
17
is aware they do occur.
18
when similar materials were tested together, more positive
19
sensitization reactions occurred than when the materials were
20
tested individually.
21
Early on in testing, it was found that
Testing procedures were changed so only unrelated
22
materials were used in a testing sequence.
Most chemical data
23
sheets and the MSDS information on fragrance materials plainly
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1
states, "The chemical, physical and toxicological properties
2
have not been thoroughly investigated.
And they say -- industry also says present testing
3
4
is adequate.
Musk ambrette was found to have neurotoxic
5
properties.
6
fed varying levels of musk ambrette.
7
of musk ambrette is generally very low, the impact was discounted
8
and no assessment was made of exposures from fragranced
9
products.
This was first discovered in 1967 when mice were
Since dietary consumption
In 1985, after studies were published on the
10
11
neurotoxic effect and it was determined that the musk ambrette
12
was readily absorbed through the skin, the IFRA recommended
13
that musk ambrette not be used in direct skin contact products.
14
Musk ambrette had been used in fragranced products before the
15
16
1920s.
Versalide had been used in the fragrance industry
17
since the 1950s.
18
accident that this material was severely neurotoxic and caused
19
the internal organs of mice to turn blue.
20
fragrances were recognized as triggers for asthma by the
21
American Lung Association and other organizations concerned
22
about respiratory health.
23
In the mid-'70s, it was discovered that -- by
Perfumes and
In spite of legitimate concerns, the industry does
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1
not include testing for neurological and respiratory effects
2
of fragrance materials.
3
can adequately regulate itself to ensure safety of fragranced
4
products.
5
information obtained from the RIFM materials and establishes
6
guidelines for use -- safe use of fragrance materials.
The industry also says the industry
The International Fragrance Association takes the
These guidelines are not binding and there is no
7
8
enforcement by the industry.
9
that musk ambrette not be used in direct skin contact products.
10
11
12
In 1985, the IFRA recommended
In 1991, the FDA still found musk ambrette in skin contact
products.
Musk xylol is found in waterways and aquatic life.
It is being found in human adipose tissue and breast mill.
In spite of this, the IFRA has made no restrictions
13
14
or recommendations concerning its use.
15
only a small segment of the population has adverse effects from
16
fragrances.
17
allergies to fragrances.
18
causes of adverse reactions to cosmetics.
19
The industry also says
One to 2 percent of the population has skin
Fragrance is one of the most common
Asthma rates have doubled in the past 20 years.
20
In 1994, there were 14 million asthmatics.
Perfumes and
21
colognes trigger 72 percent of asthmatics.
Each year, over
22
35 million people suffer from sinusitis.
23
general irritants that contribute to the incidence of sinus
Fragrances are
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1
problems.
For some, they are the primary triggers for upper
2
and lower respiratory illnesses.
Migraines affect as many as 25 million people.
3
4
Fragrances are known triggers for migraine headaches.
5
of these health conditions are adversely affected by fragrances.
6
Those with chronic lung diseases find exposure to fragrances
7
exacerbate their condition.
8
treatment of cancer often find exposures nauseating.
Okay.
9
Okay.
Many
Those receiving chemotherapy for
The attempt to regulate fragrances
10
is not an isolated incident.
11
effort to regulate fragrance inserts in magazines.
12
possible solution may be to require odorless sealed packets
13
for fragrance samples.
14
the U.S. Postal Service, because it regulates the use of such
15
inserts.
16
Okay.
In Massachusetts, there was an
One
Resolving this issue may well involved
In light of the fragrance industry's
17
unwillingness to adequately address this issue of fragrance
18
safety, it is time for the FDA to intervene.
19
resources are limited, there are cost-effective means of acting
20
and ensuring the safety of public's health.
21
resources already in place can be utilized to more effectively
22
monitor the safety of fragranced products.
23
Though FDA
Programs and
Make available fact sheets that acknowledge exposure
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1
to fragrances can exacerbate or trigger asthma, sinus or upper
2
respiratory problems, migraines and other disorders.
3
important that consumers are aware that the FDA does not require
4
pre-market testing of products.
5
children are not aware that the products they use may be
6
contributing to the their child's illness.
7
It is
Many patients with asthmatic
Such education would also increase the awareness
8
that second-hand fragrance can cause problems for others.
9
parents are unaware of the general consensus among pediatricians
10
11
Many
that fragranced products should not be used in infants.
Expand the Cosmetic Adverse Reaction Monitoring so
12
that complaints can be registered via the FDA website.
This
13
would make it easier to file complaints.
14
to pinpoint specific products that are problematic.
15
National Center for Toxicological Research can be utilized to
16
analyze fragrances that are problematic.
Data could be used
The
17
The results can be examined to determine if there
18
are substances or formulations that common in the -- that are
19
common in the products that complaints have been filed.
20
Further, the results of analysis can be examined to make sure
21
that materials banned, voluntarily or by law, are not present.
22
Also, any lack of compliance with the IFRA recommendations
23
for restricted materials should be noted.
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The product should also be examined for proper
2
labeling, et cetera.
3
fragrances makes the task of ensuring safety of each and every
4
substance beyond the scope of the FDA's resources.
5
by closer examination, several reasonable points to start can
6
be determined.
7
for the majority of skin allergies to fragrances.
8
9
The vast numbers of materials used in
However,
The fragrance mix patch test is diagnostics
These materials would be a good place to start in
determining if fragrance materials can be -- also act as
10
respiratory sensitizers.
More complaints are registered
11
concerning fragrance formulated since the mid-'80s.
12
Examination of these products may prove clues to why these
13
formulations are frequently cited as causing problems.
14
Material -- some materials may have been used on a limited basis
15
previously, but newer information increased their use.
16
For example, in the late '70s, it was found that
17
amylcinnamaldehyde and hexylcinnamaldehyde have the ability
18
to hold the scent, even after washing and rinsing.
19
of these materials have been used for some time, usage in
20
products with a wet application increased.
21
Though both
Materials introduced in the past several decades
22
need to be closely monitored, as they have no history of use.
23
This is especially true of the newer products that are used
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1
at relatively high levels in modern fragrance formulas.
2
Fragrance materials are not the only things that need examining.
3
Newer technologies, such as the use of cyclodextrins, also
4
need to be examined to determine if the use of such materials
5
add to the health risks.
6
Though health risks from an individual fragrance
7
may seem insignificant, the sheer numbers of fragranced products
8
used make them a concern.
9
materials increases the concern.
Further bioaccumulation of fragrance
Presence of fragrance
10
chemicals in fat tissue and breast milk raise the issue of
11
effects on the fetus and nursing infants.
12
concerns that should not be ignored.
These are health
13
Increases in asthma and other respiratory problems
14
triggered by fragrance exposure raises concerns over effects
15
on the airways and the lungs.
16
to be addressed by the FDA and fragrance industry.
17
MR. LEVITT:
These and other concerns need
Thank you.
I believe that the third speaker who
18
requested to speak was not able to be here.
19
do instead is we will go to the last segment of the
20
program -- baseball terms, the ninth inning.
21
up to this table Mr. Mlecko, Dr. Johnson [sic] and myself.
22
And we won't make you fax your questions up.
23
So what we will
And we'll invite
We will invite you to just walk up to that nice little
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1
microphone over there and raise what you would like to within
2
the context of either the Dr. Henney-Linda Suydam teleconference
3
from the first segment of the program, or issues that were raised
4
by any of our presentations or by the programs that we
5
administer.
I think that our original goal was to try and finish
6
7
around 4:00.
8
interest and questions, because you come out to a meeting and
9
we want to be responsive to that.
10
11
But I think we will stay longer if there is
I'm going to now walk over
there.
The other thing I've learned is some of these
12
microphones are so you can hear me and some of these microphones
13
are so this lady who's recording can hear me.
14
that you can hear me with.
15
could please introduce yourself before you ask your questions.
16
Yes.
17
MS. DONLEY:
Good.
This is the one
I think I got it.
If you
Nancy Donley.
I'm Nancy Donley, and I'm president
18
S.T.O.P. -- Safe Tables are Our Priority.
19
illness victims' organization.
20
comprised of families who have lost loved ones to foodborne
21
illness, who have been victims themselves and who are just
22
consumed -- concerned consumers everywhere nationwide.
23
We're a foodborne
We are a national organization
We are very active in policy advocacy, public
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1
education and as well as victim assistance and support.
That
2
said, I have -- and I -- this is to the third question that
3
has been brought up with the purpose of this meeting today.
4
And it has to do with communicating with consumers and as an
5
educational type of component.
6
you propose for educating the public about the concept of
7
balancing risk against benefits in public health
8
decision-making?
It's the -- what actions do
I want to start off by saying, first of all, I'm
9
10
going to make a couple comments, and I am going to ask a question,
11
as well:
12
for the usefulness and the necessary component of just being
13
truthful in disclosing all of the facts available.
14
no sugar-coating of messages.
15
One being that I think that enough cannot be said
That means
Too often, consumers are hearing conflicting
16
information.
When, on the one hand, we have the safest food
17
supply in the world, but on the other hand, we're also being
18
told is, You better treat it -- treat all your food as toxic
19
waste, because it's up to you to make sure that if it's unsafe,
20
it's your fault.
We're getting conflicting information.
21
And that's why I want to really bring up a couple
22
things, because it was brought up by Janice Oliver earlier today,
23
and that is the fight back campaign.
And I just picked up this
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1
book and kind of leafed through it that was left on the back
2
table.
3
say we offer S.T.O.P.'s assistance in producing any consumer
4
information, if you'd like, because we're starting out right
5
here with a "keep your food safe" message.
And I would also
And that's in the fight back campaign.
6
7
And here is just another instance.
If you really
stop and think about, we're not keeping food safe; we're keeping
8
people safe from unsafe food.
9
implied message here that if something goes wrong and you get
10
So we have an implicit -- an
sick, Mr. or Ms. Consumer, it's your fault.
No.
11
We're dealing -- what we have to be aware of is we're
12
dealing with our safety and how to work with it and decontaminate
13
it, if you will, or practice safe food handling practices or
14
not to take -- cross-contaminate safe food with unsafe food.
15
This year's fight back educational message is a -- is going
16
to be a really, really tough one for FDA and the consortium
17
that is dealing with it.
And I think you're really going to be challenged
18
19
here.
This year's education focus is on the cook it component
20
of the fight back four areas of -- that they position.
21
have -- and the cook it -- and these are kind of outdated in
22
here, is another thing you might want to know.
23
problem here in this particular quadrant of the fight back
AIM Reporting Service, Inc.
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We
We have a real
61
1
campaign where we're going to -- we have mixed messages and
2
conflicting information that is going out to the public.
On the one hand -- let me give you two examples.
3
4
On the one hand, both industry and government has acknowledged
5
that the only safe hamburger to eat is one that is cooked to
6
160 degrees internal temperature verified by the
7
thermometer -- that color is not a reliable indicator and that
8
you must -- the only way to ensure that it's safe is to use
9
a thermometer.
Yet you can walk into just about a restaurant
10
11
anywhere across the United States and order your burger any
12
way you want to.
13
part of the Food Safety Consortium, as well as public health
14
departments.
15
eggs.
16
acknowledged, is to make sure that they are cooked thoroughly
17
and that all whites and yolk is firm.
Now, the National Restaurant Association is
And this is a real problem.
Another example is
You -- the only way -- safe way to eat eggs is -- as
18
But you still get -- ask routinely anywhere you walk
19
into the -- into restaurants, How do you want your eggs prepared?
20
21
22
23
That's conflicting information.
We can't be a "do as a say,
not as I do" society and expect any changes in consumer behavior.
And that's the key here.
It's not consumer education; it's
behavior modification we should be after.
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And we cannot achieve that if we are sending out
1
2
conflicting information to the public.
3
this points out is kind of an overall larger problem that I
4
hope FDA is going to -- and CFSAN, in particular, is going to
5
recognize the need for further federal regulations throughout
6
the food industry, and that we cannot have -- and the Food Code
7
is a great example of this.
In the Food Code, it's because municipalities can
8
9
That said, I think what
adopt any portion that they want to of it.
They can take -- they
10
look at the Food Code as a menu and say, I'll take this part
11
and this part and this part, but I don't want this part or I -- and
12
I'll modify this part.
13
for food throughout the United States.
We cannot have a patchwork safety system
Public shouldn't be more protected in one area or
14
15
one state or one county or one city -- more protected there
16
than they are anywhere else.
17
we, the public, are looking to the federal government to
18
establish food safety standards that must be utilized evenly
19
throughout the United States.
20
enough.
And where we -- this is where
And I can't emphasize that
21
It's once you get strong federal regulations that
22
you build a good base to develop these partnerships that you
23
are talking about on the state and local level.
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And once you
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1
have national regulations, national performance standards, then
2
you can branch out and develop your partnerships.
3
then you will probably have a very even system across the
4
country.
5
And I think
You then stand a chance of really developing
6
something good and something wonderful.
7
on a national framework and a level playing field throughout.
8
So I guess that said -- I'm sorry I'm taking so much time up
9
But it has to be based
here -- I do -- I really feel we have this coming up in
10
September -- this education -- I'm going to end with the
11
education component here of this fight back campaign.
12
And I'm -- I am very, very concerned as a president
13
of an organization who -- we are routinely giving out
14
information to people who ask it -- of what we should do.
15
then these same people are hearing other things back or just
16
viewing other things -- getting wrong, wrong, unsafe
17
information coming back to them from industry.
18
MR. LEVITT:
Thank you very much.
And
Thank you.
I'm not going
19
to try and respond to every point made, but I will highlight
20
a couple of items.
21
your whole organization for the important advocacy you're
22
arguing in the area of food safety.
23
One, I want to begin by commending you and
As Ms. Donley mentioned, she and -- I don't
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1
know -- all -- most -- many members of your organization have
2
really seen the dangers of food safety as -- firsthand and had
3
members of their families become very sick or even die as a
4
result of foodborne illness.
5
comes with more credibility than that.
And to me, there is nobody who
6
In fact, when I first saw -- I've never said this,
7
but when I first saw the name of your group, Safe Tables are
8
Our Priority, I thought it stood for -- as S.T.O.P., Stamp Out
9
Pathogens.
10
Maybe that's a -- and so let me begin with that.
The issue of cooking:
You're right.
We will be challenged.
We -- I mentioned that we're -- are coming forward,
11
12
in addition to the fight back campaign, with a proposed
13
regulation on egg safety, one component of which is safe handling
14
practices for consumers, which will include both refrigeration
15
and cooking thoroughly.
16
explain to people is, Wait a minute.
17
had this all my life.
But you're right.
The hard thing to
I grew up on this.
I've
You know, how do we convey how the world has really
18
19
changed?
20
the materials, you know, we welcome.
21
say, Cook thoroughly.
22
regulated by USDA, you know, cook to a certain degree level.
23
And, you know, any help as we go through developing
We can put on labels that
Or as you say, in meat, even if that's
It's different from making it happen.
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I will give
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1
you just a couple of anecdotes that I've just experienced.
2
And they're only anecdotes.
3
little disposable -- I'll put in a plug for USDA products.
4
There is now a little disposable thermometer that you just put
5
in your hamburger, hold it for six seconds, pull it out.
And if it's white, it's -- you have to cook it more.
6
7
You know, they do have now the
And if it's black, it's heated to the proper temperature.
8
And I can tell you I put it in and it's still white, so I have
9
to close the oven again.
10
are reasonably priced.
11
something we need to do.
But, I mean, they do work and they
And people need to understand that's
But you're right -- behavior modification.
12
I think
13
you're exactly right.
14
New England state over vacation, and it was on a border.
15
I'm honestly not sure if it was in Massachusetts or if it was
16
in Connecticut, because it was right on that border.
17
people at the next table ordered a rare -- a hamburger medium
18
rare.
19
to you that way.
20
21
I also -- good news -- I was up at a
And the waitress said, I'm sorry.
So
But the
We can't serve it
So there is -- the message is starting to get out.
But clearly, more needs to be done.
The last point I wanted
22
to address is the issue of federal standards.
23
think, coming to understand that in a real way.
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And we are, I
We have had,
66
1
as I mentioned, a number of meetings with state and local
2
officials about how to expand food safety coverage in an
3
appropriate way.
And one of the first themes that we had -- we had
4
5
a list of criteria.
One of the first themes was uniform minimum
6
standards.
7
much misinterpreted.
8
standards became common minimal standards -- became exactly
9
what you suggest as allowing or even encouraging a patchwork.
10
And at least within our internal discussions -- and
11
you'll see in the response that the administration gave to the
12
Academy, you know, that the first criteria is strong national
13
standards so that we do have a level playing field across the
14
country, you know, where we can do that.
15
the HACCP regulations from either Agency are a major step in
16
that direction.
And what we found was, number one, that was very
I found that common uniform minimum
The last thing is the Food Code.
17
I think, you know,
I would just invite
18
any of our state and local health officials here, if you would
19
like to comment at all on the Food Code, on implementation
20
efforts, on how that is seen from the receiving end, because
21
we do see it as a critical component to the whole food safety
22
effort.
23
MS. BOHM:
My name is Shirley Bohm, and I'm the food
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program manager with the Division of Food, Drugs and Dairies,
2
Illinois Department of Public Health.
3
very strong proponents of the FDA Food Code.
4
January, we adopted critical portions of the Food Code into
5
Illinois rules.
6
departments in Illinois have those as their -- part of their
7
legal base.
We are, in Illinois,
In 1996, in
And the majority of the local health
8
We felt at the time that our director, and basically
9
the entire department -- all of the food program -- felt that
10
it was a very large document and it would be very difficult
11
to make that changeover with the -- with so much material.
12
So we started with step one by incorporated critical
13
sections -- all the time temperature control and consumer
14
advisory and hand contact with ready-to-eat food and a number
15
other -- of other issues.
16
We're at the stage now of finishing up a
17
review -- continued review of the Food Code, and we expect to
18
share a draft with our stakeholders here in the state later
19
this summer and then propose it for -- the entire Food Code
20
for adoption.
21
I would like to make one recommendation to FDA.
I think this might help you, and certainly would help us.
22
The two-year cycle that you have where you come out
23
with a new Food Code every two years is very difficult for the
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1
recipients.
Rulemaking is a long and sometimes difficult
2
project.
3
don't think -- I don't see how you have enough time to continue
4
doing that two-year cycle.
And we can't keep up with you.
And CFSAN can't -- I
5
I think now we've resolved a lot of the issues with
6
the conference for food protection and a lot of input from the
7
industry and regulatory agencies, as well.
8
be so difficult now for you to maybe go on a four-year or six-year
9
cycle that would correspond with the conference for food
So perhaps it won't
10
protection, because I know you take a lot of input from the
11
conference.
12
So that was a recommendation, I think, from a lot
13
of people I've talked to, and certainly would make my life a
14
lot easier.
Thank you.
MR. LEVITT:
15
Wait.
Before you -- could you help
16
us?
17
hasn't revised it in the next four years.
18
about it in that way.
19
in your state, knowing how your state counterparts are, do you
20
foresee the result being broad in uniform adoption, or do you
21
perceive the result being a patchwork approach as was suggested
22
with a degree of worry a few moments ago?
23
If you look ahead four years from now -- let's assume FDA
MS. BOHM:
We'll try and think
Do you see -- knowing how it's viewed
With the present system where it's a
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1
recommended document -- a model document that's made available
2
for everyone to adopt as they will, certainly every
3
jurisdiction, whether it's a state or a local level, will have
4
the opportunity, then, to tweak it as they will or as they want
5
in response to local situations, to local lobbyists, to whoever
6
makes comment.
7
Without changing a system so that there's a -- oh,
8
I don't want to use that M word for mandatory -- but without
9
changing the system that you will end up with some local
10
differences at the -- at whatever level -- whatever
11
jurisdictional level.
12
pot, let's say, to encourage state and local agencies to adopt
13
as is -- for example, a model code as is -- perhaps funding
14
or whatever -- I can't see -- I can't foresee that situation
15
changing, really.
16
MR. LEVITT:
17
MS. BOHM:
18
MR. LEVITT:
And without something to sweeten the
Okay.
But you just gave me one idea.
Good.
And I'll take that -- your idea.
My
19
impression on the Food Code -- I'm not a long-term expert.
20
My impression is that this year was viewed as a breakthrough
21
year and that there had been a lot of opposition to some key
22
points.
23
And with basically an agreement reached at the
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1
conference of food protection last -- about a year ago by
2
now -- as basically ratified in the Food Code that came out
3
in January or February -- January, I guess -- that this really
4
should become the code we are trying to get implemented.
5
And it is probably not useful as people in the process
6
of implementing for us to keep moving the target a little bit.
7
So I certainly will take that -- to make that suggestion back
8
and the other idea back, too.
MR. MLECKO:
9
10
pot."
Shirley, you mentioned "sweeten the
How can we sweeten the pot?
MS. BOHM:
11
Well, I can use the USDA setup -- USDA
12
and State Department of Agriculture setup with meat and poultry
13
inspection.
14
agriculture departments to basically adopt, as is, federal
15
regulations, make their program equivalent or identical to the
16
federal program and, therefore, they also get -- I believe it's
17
50 percent of the program funded by the feds.
18
19
That's one possibility where USDA requires state
That's a possibility.
Certainly that's one setup.
I, you know, don't know enough about how it could work.
20
may be other alternatives.
21
some federal funding tied to that uniform adoption.
There
But that's one possibility of having
22
MR. LEVITT:
Thank you very much.
23
Who else has a question?
Yes.
Please.
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MS. SOSA:
1
My name is Merle Sosa, and I'm manager
2
of food safety programs for Food Animal Concerns Trust, or FACT.
3
And my question has to do with the announced notice of public
4
rulemaking that was done in May of last year for Salmonella
5
enteritidis in shell eggs.
6
your presentation about things you've got coming up for eggs,
7
But none of those related to anything on-farm.
I should mention that our group is involved -- the
8
9
And you mentioned a few things in
group that I represent -- what we advocate is more
10
humane -- using animal husbandry systems to improve the safety
11
of milk, meat and eggs.
12
concerned with is the fact that there doesn't seem to be any
13
regulation on the horizon that would relate to systems on the
14
farm.
So one of the things that we're
So what you're doing is implementing programs that
15
16
will be -- I think you mentioned refrigeration and
17
transportation and things like that.
18
the best chance for trying to prevent SE in eggs is right on
19
the farm.
20
Pennsylvania where we use extensive SE testing programs to try
21
and prevent SC.
22
23
But our group feels that
And we do have model farms.
We have 14 in
So what we don't understand is what happened in the
interim process.
There were comments made.
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We tried to find
72
1
out more information on the comments and what the whole process
2
is going to be, but there hasn't been anything that's come out
3
since comments were made in August.
4
Number one, is there going to be anything on the horizon
5
concerning regulations for on-farm pathogen protection programs
6
with regard to SC.
So my questions are:
And number two, my question -- my second question
7
8
relates to communication.
9
kind of left with:
Once comments are submitted, you're
Where are things going?
And so one thing
10
that we've tried to do is we've tried to contact FDA officials
11
to check on the status.
12
whatsoever.
And we have received no response
Whereas, when we contacted the USDA for their part
13
14
of this whole joint process, we received very, very prompt
15
response.
16
want to communicate.
17
stakeholders and we want to communicate with you.
18
are my two questions.
19
So my take on the FDAMA modernization act was:
We
We want two-way communication with the
MR. LEVITT:
Okay.
Thank you.
So those
Number one, if
20
you'll leave me a card or something, I'll be sure that somebody
21
more specifically knowledgeable than me will call you back.
22
But in general, let me kind of give you broad brush.
23
one, we recognize that the first steps I outlined we're doing
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1
because they're the clearest and most direct that can be
2
done -- if you will, the easiest -- and so we ought to get them
3
done.
The refrigeration will limit further growth of
4
5
Salmonella enteritidis, and that's important.
6
handling practices -- refrigeration will do the same and the
7
cooking will kill the bacteria.
8
however, where we're relying on the consumer to be the principal
9
checkpoint.
You are right.
And the safe
We do not want a system,
We've got to go back to the farm.
There have been some successful farm quality
10
11
assurance programs in Pennsylvania.
We have within the
12
priorities documents -- you'll see it -- it is on the B
13
list -- to continue to foster those.
14
this area myself, but the discussions I've had on it so far
15
have at least convinced me that it is a -- it's a hard problem
16
to try to figure how to solve.
I am not an expert in
That doesn't mean we shouldn't try to solve it.
17
18
I said when I was up there, you know, eggs -- Salmonella
19
enteritidis is one of the big food safety challenges we have.
20
I'm not sure that the comments in totality gave us a clear
21
direction.
But, you know, we will try to get done this year
22
what we've laid out and come back and follow that more intensely
23
in the future.
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1
2
I don't know if that answer is fully satisfactory
to you, but it's at least truthful and honest.
3
MS. SOSA:
4
MR. LEVITT:
5
6
Right.
We appreciate that.
And did I hit both of your questions,
or did I -MS. SOSA:
Well, I'd like you to address -- well,
7
I guess one of things I have about the communication issues
8
is there -- I guess my question is, is there a directive to
9
the FDA personnel?
I guess what I'm trying to say is some people
10
feel that regulatory agencies are insular and are hard to
11
communicate with.
12
is trying to change that impression.
And I think that the FDAMA, as a document,
13
And so I guess what my question would be is, is there
14
going to be some work within the FDA to try and make FDA personnel
15
more accessible and have some responsibility for them to -- if
16
people do reach out to them, that they'll come back and at least
17
respond either by e-mail or some other kind of communication?
18
MR. LEVITT:
Okay.
I think -- let me address this
19
first in the case of a rulemaking proceeding, which is different
20
from a lot of other things.
21
is what's called ex parte contacts with the idea that the process
22
is, I'm afraid, kind of an arms-length process.
23
I tend to like these public meetings, because it gives you a
One of the issues in rulemaking
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That's why
75
1
chance to get more give and take than just read the document,
2
summarize the comments and figure where to go from there.
And we're doing -- you know, we've done workshops
3
4
in a number of areas.
5
here for people to extrapolate.
6
we really are not supposed to be talking to people outside of
7
the process, because that creates an elements of unfairness.
8
9
10
11
But actually, it's not exactly the case
I'm talking to you now.
called?
When we issue a proposed rule,
I'm talking to somebody else.
Who didn't call?
So it unfortunately does put you at a feeling like:
I'm in the dark.
And I don't -- I mean, the best solution
12
to that is speed.
13
from proposal to final in less than 60 days.
14
been less than 30 days.
15
count them all.
16
Who
When we did the juice labeling rule, we went
It might have
It was so fast, we can't even -- can't
But that was unusual.
We had a particular time
17
element we had to hit for the fall -- apple season.
18
tried to say to people and staff who literally worked all day,
19
all night, all weekend for about a month or a month-and-a-half
20
on that, we will reserve that for when there is not just
21
importance, but time certain urgency where we'll bring out our
22
staff so fast that they won't be here to do the next one.
23
And I've
But part of it also is, when you think of my boulders
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1
and pebbles, is how many of these can we systematically address
2
well at once, including follow through.
3
following through on seafood.
4
on the fresh foods and produce, both domestically and
5
internationally.
6
areas can we take on at once?
7
We're working on
We're working on follow through
And so part of it is how many of these major
And I wanted to be sure the ones we do take on
8
are -- we can do right and thoroughly and not have everything
9
neutralize it out.
So I think it's a combination of how much
10
we know, how clear the comments were, what its priority is
11
against other things.
12
13
But yes.
We know it's a real problem.
We've got to get to it.
MS. SOSA:
I guess in a situation like the SC regs
14
when they've basically gone on for this long -- I mean, it's
15
been -- what -- eight months since the comments were received.
16
Then in that situation, I guess, as stakeholders, what we want
17
is at least perhaps some status report that's put onto the web
18
that says, you know, We're working on this, or, you know, We
19
foresee in the horizon X regs.
20
And that way, at least we're -- we feel like we're
21
part of the loop and we can -- and if there's something that
22
we want to address, we could at least file more comments or
23
do something.
But we feel like there's -- we're just in this
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1
black abyss.
And I understand.
I, too, am an attorney, also.
And so I understand the concept of ex parte
2
3
communication and things like that and how that would be a
4
problem.
5
something that we can have.
But once it gets so lengthy, there has to be at least
MR. LEVITT:
6
7
Okay.
That's a valid point.
Thank
you.
8
Other questions or comments?
9
While he's walking up there, I'll welcome Ken Moore,
10
who's executive director of the Interstate Shellfish Sanitation
11
Commission.
12
who travelled the furthest today.
14
I think maybe he wins the award for the person
Okay.
13
Yes?
We'll let you introduce yourself, though,
for the record.
MR. MOORE:
15
I'm Ken Moore, and I am with the
16
Interstate Shellfish Sanitation Com.
17
not so much a question.
18
organization, quite frankly, provided the blueprint that the
19
Conference for Food Protection used when they developed their
20
organization.
21
conference.
22
23
I really want to comment,
Regarding the Food Code, our
And quite frankly, we copied ours from the milk
Ours is -- the Interstate Shellfish Sanitation
Conference is a little different in the fact that we deal with
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1
interstate shipments of shellfish.
Therefore, when our
2
organization adopts a requirement, every state is expected to
3
go home and adopt the requirement in their entirety.
4
are no choices regarding whether -- you know, whether you can
5
adopt a portion or not, because not only is FDA, but the states,
6
as well, expect reciprocity in programs.
There
7
I'm going to tell you with the Food Code, if every
8
state was required to adopt the Food Code in its entirety, it
9
would look different today.
One of the reasons you have the
10
adoption of the document that you have or the ratification by
11
the states is they recognize the fact that they would have
12
options when they return home.
13
you expect every state to adopt the Food Code as it is presently
14
written.
15
You have a unique talent if
I see difficult issues before our
16
conference -- issues of things like particular situations in
17
shellfish which affect immuno-compromised individuals.
18
issue are debated over years.
19
frankly, found themselves in situations where certain public
20
health officials felt differently about the right of choice
21
the consumers had.
Those
The organization has, quite
22
Those issues become very difficult if you're in a
23
process in which the results of the discussion will result in
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every state having to adopt each requirement in its entirety.
2
So I only want to suggest that you do have a challenge if your
3
purpose is to develop a Food Code in which every state is going
4
to adopt it.
5
when she said that we'll sweeten the pot.
I mean, I recognize what Shirley said, as well,
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Well, quite frankly, if you look at democracy, and
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that's what the country's all about, everyone supposedly has
8
their own process.
9
looking at situations that aren't necessarily interstate
And when you're looking at food, you're
10
shipments of food.
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frankly, the states have that choice as to how they plan to
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regulate it.
Quite
You find different opinions in different parts of
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14
the country.
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of the country.
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you.
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They're intrastate shipments.
You find different cultures in different parts
Again, you have some unique challenges.
MR. LEVITT:
Thank you.
Thank
If I was Mark Barnett, I'd
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be at the point that I'd say we have time for one more question.
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And seeing none, let me again thank all of you for coming,
20
thank the presenters, again thank the staff both in Chicago
21
and from back in Washington.
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Mr. Mlecko, thank you for your hospitality --
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MR. MLECKO:
You're welcome.
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1
MR. LEVITT:
2
Armstrong from the Moffett Center.
3
on this issue.
4
will conclude the meeting.
And we'll continue to work
So we wish you all a safe trip back home.
(Whereupon, at 4:25 p.m., the hearing was
5
6
-- as host of the meeting, and Dr.
concluded.)
7
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This
81
REPORTER'S CERTIFICATE
1
2
3
4
IN RE:
Chicago District Video Teleconference
5
DATE:
April 28, 1999
6
LOCATION:
Chicago, Illinois
7
8
I hereby certify that the proceedings and evidence
9
are contained fully and accurately on the tapes and notes reported
10
by me at the hearing in the above case before the Food and Drug
11
Administration.
Date:
May 7, 1999
Official Reporter
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