GRADUATE SCHOOL
U.S. DEPARTMENT OF AGRICULTURE
* * *
FDA FOOD ADVISORY
COMMITTEE MEETING
* * *
FOOD BIOTECHNOLOGY SUBCOMMITTEE
OF THE FOOD ADVISORY COMMITTEE
MOLECULAR CHARACTERIZATION
CENTER FOR FOOD AND APPLIED NUTRITION
Wednesday, September 24, 2003
J.W. Marriott Hotel
1331 Pennsylvania Avenue, N.W.
Washington, D.C.
The meeting convened,
pursuant to notice
at 8:36 a.m., before Acting Chairman Francis F.
Busta.
MEMBERS PRESENT:
JONATHAN ARIAS, Ph.D.
Associate Research
Scientist
Department of Biological
Sciences
University of Maryland,
Baltimore County
1000 Hilltop Circle
Baltimore, Maryland 21250
Tel: 410-455-3470
Fax: 410-455-3875
Arias@umbi.umd.edu
BOB B. BUCHANAN, Ph.D.
Professor
University of California
Department of Plant and
Microbial Biology
111 Koshland Hall
Berkeley, California 94720
Tel: 510-642-3590
Fax: 510-642-7356
view@nature.berkeley.edu
FRANCIS FREDERICK BUSTA,
Ph.D.
Emeritus Professor
University of Minnesota
Department of Food
Science and Nutrition
1334 Eckles Avenue
St. Paul, Minnesota 55108-6099
Tel: 612-624-3086
Fax: 612-625-5272
DOUGLAS GURIAN-SHERMAN,
Ph.D.
Science Director,
Biotechnology Project
Center for Science in the
Public Interest
1875 Connecticut Avenue,
N.W.
Suite 300
Washington, D.C. 20009
Tel: 202-332-9110 Ext.
377
Fax: 202-265-4954
dgurian-sherman@espinet.org
MEMBERS PRESENT (Continued):
ANNE R. KAPUSCINSKI,
Ph.D.
Professor, University of
Minnesota
Department of Fisheries
& Wildlife
180 McNeal Hall
1985 Buford Avenue
St. Paul, Minnesota 55108
Tel: 612-624-3019
Fax: 612-625-8153
ark@fw.umn.edu
ABIGAIL A. SALYERS, Ph.D.
Professor of Microbiology
Department of
Microbiology
University of Illinois at
Urban-Champaign
B103 CLSL
601 S. Goodwin Avenue
Urbana, Illinois 61801
Tel: 217-333-7378
Fax: 217-244-8485
Temporary Voting Members:
DENNIS GONSALVES, Ph.D.
Center Director
Pacific Basin
Agricultural Research Center
99 Apuni Street, Suite
204
Hilo, Hawaii 96720
Tel: 808-932-2100
Fax: 808-969-6967
Dgonsalkves@pbarc.ars.usda.gov
STEPHEN BENEDICT, Ph.D.
Department of Molecular
Biosciences
University of Kansas
1200 Sunnyside Avenue
Lawrence, Kansas
66045-7534
Tel: 785-864-4007
Fax: 785-864-5294
sbene@ku.edu
MEMBERS PRESENT (Continued):
CALVIN QUALSET, Ph.D.
Genetic Resources
Conservation Program
DANR Building, Hopkins
Road
University of California
Davis, California 95616
Tel: 530-754-8502
Fax: 530-754-8503
coqualset@ucdavis.edu
NINA FEDOROFF, Ph.D.
519 Wartik Laboratory
Huck Institute for Life
Sciences
Penn State University
University Park,
Pennsylvania 16802
Tel: 814-863-5717
Fax: 814-863-1357
Industry Representative:
JAMES ASTWOOD, Ph.D.
Director, Food and Feed
Safety Policy
Monsanto
800 North Lindbergh
Boulevard
St. Louis, Missouri 63167
Tel: 314-694-8396
Fax: 314-694-8562
james.d.astwood@monsanto.com
ALSO PRESENT:
MR. BOB LAKE
MS. JEANETTE GLOVER GLEW,
CFSAN
MR. MICHAEL HANSON
(Public Comment)
DR. JAMES MARYANSKI,
CFSAN
DR. THOMAS CEBULA, CFSAN
C O N T E N T
S
AGENDA ITEM PAGE
Welcome and Introductions 6
Acting FBS Chair
Conflict of Interest Statement 9
Welcome from FDA 13
Charge and Questions 23
Acting FBS Chair
FDA's Biotech Food Safety Assessment 29
Ms. Jeanette Glover Glew, CFSAN
Questions of Clarification 43
FBS Members
Codex Approach 74
Dr. James Maryanski, CFSAN
Questions of Clarification 92
FBS Members
FDA's Discussion Paper — Molecular
Characterization 103
Dr. Thomas Cebula, CFSAN
Questions of Clarification 122
FBS Members
Public Comment 153
Summary and Review of Charge and
Questions 172
FDA
Discussion 179
FBS Members
Response to Questions 194
FBS Members
Concluding Comments 334
Acting FBS Chair
P R O C E E D
I N G S
CHAIRMAN
BUSTA: The meeting is called to
order. And welcome, all of the
committee members, guests, and the members of FDA to the--this Biotechnology
Subcommittee meeting of the Food Advisory Committee.
My
name is Frank Busta. I'm a professor
emeritus at the University of Minnesota.
I'm a member of the, let's see, the term is full committee. I'm--that is not implied that I'm full of
it, but some people would say it. And
I've been asked to chair this meeting as an acting chair.
In
front of you, you have an agenda, and, as you see, in addition to welcoming
you, we'd like to have our introductions so that everybody knows who everyone
is, and we have it on the record.
I
believe that we're asked always to talk into the microphones because it is
being recorded, and that gives us a record, as well as someone taking notes.
So,
if we could start with introductions, telling us basically who you are and
your--the
committee. Douglas, would you start?
DR.
GURIAN-SHERMAN: Doug
Gurian-Sherman. I'm with Center for
Science in the Public Interest.
CHAIRMAN
BUSTA: And you are a member of the--the
regular member?
DR.
GURIAN-SHERMAN: Yes, I'm a member of
the subcommittee.
DR.
QUALSET: I'm Cal Qualset, professor
emeritus, University of California at Davis.
I'm a member--a temporary member of the subcommittee.
DR.
BENEDICT: Steve Benedict, University of
Kansas, and I'm a temporary member.
DR.
ARIAS: Jonathan Arias, University of
Maryland. I'm a subcommittee member.
DR.
FEDOROFF: Nina Fedoroff, Penn State
University. I guess I'm a temporary
member.
CHAIRMAN
BUSTA: Abigail?
DR.
SALYERS: Abigail Salyers, University of
Illinois, and former President of the American Society for Microbiology. And I'm not sure what kind of member I am.
CHAIRMAN
BUSTA: You are a member of the
subcommittee.
DR.
SALYERS: Oh, okay.
DR.
BUCHANAN: Bob Buchanan, University of
California at Berkeley, and I believe I'm member.
DR.
GONSALVES: Dennis Gonsalves. I'm at Pacific Basin and Agriculture
Research Center, and I'm a temporary member.
DR.
ASTWOOD: I'm Jim Astwood. I'm with Monsanto, and, I'm the industry
liaison.
CHAIRMAN
BUSTA: And Mike?
DR.
WATSON: Mike Watson, the Food and Drug
Administration.
CHAIRMAN
BUSTA: And Mike does all the work.
All
right. To get this organized and
straight, I would like you to refer to our agenda. You see estimated times to accomplish what we need to do today on
the agenda.
We
hope that we can stay fairly close to that.
I will try to be as firm a chair as possible so that we do not diminish
our opportunities for discussion and summaries in the afternoon.
Mike,
we're five minutes ahead of time, but I'd like--I don't mind that at all.
DR.
WATSON: That's fine.
CHAIRMAN
BUSTA: I will turn over the conflict of
interest statement, et cetera, to Mike Watson.
DR.
WATSON: Good morning, again. I'm Mike Watson. I'm the Acting Executive Secretary for the Biotechnology
Subcommittee of the FDA Food Advisory Committee.
First,
I would like to read the temporary voting member appointment and conflict of
interest statements into the record.
By
the authority granted under the Food Advisory Charter of July 2002, the
following individuals have been appointed as temporary voting members by Joseph
A. Levitt, Director of the Center for Food Safety and Applied Nutrition:
Dr.
Steven Benedict;
Dr.
Nina Fedoroff;
Dr.
Dennis Gonsalves; and
Dr.
Calvin Qualset.
With
regard to the issue of conflict of interest, committee members, both permanent
and temporary, were screened for interest in bioengineered food
developers. As a result of this review,
in accordance with 18 U.S.C., Section 208 (b)(3), Dr. Robert Buchanan and Dr.
Dennis Gonsalves have been granted a particular matter of general applicability
waiver that permits them to participate fully in matters at issue.
Copies
of their waiver statements may be obtained by submitting a written request to
the Agency's Freedom of Information Office, Room 12A-30 of the Parklawn
Building.
We
would also like to note that Dr. James Astwood is participating in this meeting
as the acting industry representative, and is a non-voting participant.
With
respect to all other participants, we ask that, in the interest of fairness,
that they address any current or previous financial involvement with any firm
that develops or sells bioengineered food crops.
Finally,
FDA received a letter on Monday this week, September 22, 2003, from the Center
for Science in the Public Interest, CSPI, related to the work of this
subcommittee. This letter was signed by
Dr. Gurian-Sherman, a consumer representative on this subcommittee, on behalf
of himself and two other subcommittee members, Drs. Arias and Kapucinski.
The
letter expresses concern about FDA's management of the subcommittee, selection
of agenda topics, and other issues. FDA
has provided copies of this letter to the subcommittee members, and copies are
available to the public.
FDA
appreciates receiving suggestions for enhancing the work of the
subcommittee. Since this letter was
submitted too late for FDA to fully consider its contents and suggestions for
changes for this meeting, we intend to examine the letter carefully and respond
following this meeting.
For
today, we intend to focus on the agenda that we have prepared. Mr. Chairman, we note that one of the issues
raised in the CSPI
letter dealt with future agenda items
for the subcommittee.
We
leave it to your discretion; but, if time permits, FDA will be interested to
hear any suggestions that subcommittee members may have on future agenda items.
I'll
turn it back over to Dr. Busta.
CHAIRMAN
BUSTA: Well, thank you, Mike.
I'm
not sure if we got a copy of that letter by e-mail before this meeting. I'm not sure how many of you are in a
position to see your
e-mail en route. The--we'll have an opportunity to look at
that in case you hadn't seen it earlier; and, as Mike indicated, we will do our
best to get through the agenda. And we
will place that at the end of the agenda for comment, and we can expand that
for other comments beyond the letter as for future agenda items.
All
right. Now, we're going to have a
welcome from FDA. And I assume that's
Bob Lake?
MR.
LAKE: Yes.
CHAIRMAN
BUSTA: They're really neglecting
you this morning, Bob. They didn't give you a name card.
MR.
LAKE: Well, that's all right.
Let
me--well, again, I am Bob Lake. I'm the
Director of Regulations and Policy at the Center for Food Safety and Applied
Nutrition. I report directly to Joe
Levitt, and one of the things in my portfolio is policy issues relating to
bioengineered foods. Jim Maryanski, Dr.
Maryanski, who will be talking to you later, and who I think is--most of you
know very well--has been my technical advisor for probably 15 years.
He
is the biotech coordinator, but we established that position back in the late
'80s; and his title and mine have changed a little bit over the years. But we have worked very closely together
throughout that time.
I
want to officially, on behalf of SISAM management, welcome you here to this
meeting. I know everyone has very busy
schedules, and it's certainly hard to find a time where we can get everyone.
But
we very much appreciate all of you being here.
You are important to us. We very
much appreciate your time, your consideration; and will value whatever advice
we get from you.
I
thought I would take a little bit of a moment to just sort of update you on
sort of what's been going on, or, in some cases, not going on. Just to give you a little bit of a backdrop,
I'm going to try to do this very quickly.
As
you all I think know, FDA is only one of the agencies in the Federal Government
that is involved in issues that relate to bioengineered foods. The Department of Agriculture, most notably. The Animal, Plant, Health and Inspection
Service has responsibility for, you know, the planning of bioengineered
plants. EPA has responsibility for
genetically engineered pesticides that are genetically engineered into new
plant varieties. And then FDA, of
course, has the responsibility for the safety of foods, and, you know, again,
that's--we're talking about what happens to the person who eats the food.
Also,
we have the responsibility for animal feeds, and so we have a concern about
that, as well.
Since
the StarLink episode of a few years ago, there's been a sense across the
agencies that there has been a need for greater interaction. And, indeed, there have been numerous
meetings among the agencies, these agencies, also others, from time to time, to
deal with a couple of sort of cross-cutting issues. These, by the way, have generally been held under the auspices of
the Office of Science and Technology Policy, OSTP.
One
of these issues that we have grappled with in an interagency context has
related to the potential for new plant varieties that are still in the
developmental stage perhaps inadvertently contaminating traditional food
crops. And the OSTP, after numerous
interagency discussions, published a document setting out some tentative
thoughts about that and invited public comment.
Following
that, the--there was a recognition that there's a growing concern about
the use of food crop plants to produce
pharmaceutical, industrial chemicals.
We generally refer to these as pharm plants, spelled P-H-A-R-M, as a
convenient shorthand for talking about these kinds of crops.
As
some of you know, we did have an episode last year. Nothing got into food.
But it sort of heightened the concerns within the government about the
potential for contamination of food with non-food producing crops, such as corn
used to produce pharmaceuticals.
Those
discussions are ongoing. They have not
come to closure yet. When they do, I expect that there will be something
similar coming out of that to the OSTP publication that I mentioned a moment
ago.
Of
course, throughout all of these discussions, FDA is going to the meetings,
participating in the meetings, with the recognition that our primary
responsibility really is about the safety of the food; and we try to stay
focused on that as we go through these discussions,
recognizing there are many other
issues.
But
the one that is primary importance to FDA, and that we like to stay primarily
focused on is the safety of the food itself.
We--as
you all know, we published a proposal to make our current consultation process
mandatory. We have not taken final
action on that. Any of you who read the
proposal will know that we raised in that proposal an issue about whether we
actually had the legal authority to make the process mandatory. That has continued to be an issue.
The
other thing that has come along is the events of September 11th of 2001, and a
need to focus a lot of attention on bioterrorism. I can tell you personally that that issue has largely taken over
my life since I head the office that is responsible for developing FDA's
regulations to implement that new law that was passed by Congress and signed
President Bush June a year ago.
The
other thing, of course, that we always face is that there are a large number of
very
important issues before the agency at
any given time, and we can't deal with all of them all at once.
When
our Center Director, Joe Levitt, came back in 1998, one of the practices he
instituted was a process, a priority-setting process, that results in something
that we normally refer to as the Yellow Book, that articulates the Center's
priorities.
And
the A-list things are things we are going to do within the current, you know,
fiscal year. B-list are things that are
being worked on, and anything that's not on either of those two lists is not
going to be done for a while.
We
have--again, one of the other things that Mr. Levitt instituted was a process
of seeking public input on what these priorities are. And we can't make everybody happy. We can't deal at any instant with anything--with everything that
is deemed by even us to be important; but we do try to have this orderly
process for setting priorities. And one of the things you will note is that the
mandatory proposal is not an A-list
item.
The
other thing that we are continuing to work on, but have not come to completion
on yet, is allergenicity. This
subcommittee considered some of those issues at your first meeting. We still intend to come back to the
subcommittee with allergenicity issues, but we have not, you know, we were not
ready to do that for this meeting.
We
generally are trying to keep up with the science, though, we certainly see this
subcommittee as helping us in that process.
And, as you will hear more about a little later, we have, over the last
four years, participated actively in the Codex Alimentarias effort at the
international level to develop principles and guidelines for the assessment of
bioengineered plants and also bioengineered microorganisms used in food
production. And Dr. Maryanski will talk
about some of that as it relates to the agenda before you today.
In
the meantime, FDA is still following the guidance that we issued in 1992. We--it
continues to be our belief that all of
the foods that are in the marketplace in the United States today have gone
through that process; and, also, so far as we know, none of the foods that have
successfully completed that consultation process is presenting any kind of
public health problems to American citizens.
Nonetheless, we recognize that scien