UNITED STATES DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C.

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:

ADVISORY COMMITTEE ON :

BIOTECHNOLOGY AND 21ST CENTURY :

AGRICULTURE (AC21) :

NINTH PLENARY MEETING :

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A meeting in the above-entitled matter was held on Tuesday, August 9,
2005, commencing at 8:30 a.m., at Loews L\'Enfant Plaza Hotel, Ballroom
D, Washington, D.C. 20036.

Dr. Patricia Layton, Chairperson

[A P P E A R A N C E S]{.underline}

[Page]{.underline}

Dr. Michael Schechtman, USDA 3

Dr. Patricia Layton, Chairperson 11

Chuck Conner, Deputy Secretary of Agriculture 37

Dr. Canice Noland, European Commission 177

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

DR. SCHECHTMAN: Good morning. This is the ninth meeting of the U.S.
Department of Agriculture\'s Advisory Committee on Biotechnology and
21st Century Agriculture or AC21. My name is Michael Schechtman and I\'m
the Executive Secretary and Designated Federal Official for AC21. I\'d
like to welcome our committee members. I think we expect to see sixteen
of them, of you, by the end of the day, and another one tomorrow, and,
also, I believe we have one of our ex officio members here today as
well.

We have four new members here today and I\'d like to welcome each of
you. We\'ll have more formal introductions in a little while. To my left
is the AC21 Chairman, Dr. Patricia Layton from Clemson University. To my
right are our facilitators, Ms. Abby Dilley and Ms. Kathy Grant from the
organization, RESOLVE, and to my left at the end is Cynthia Sulton from
the organization, HW&W, who are partners in helping to make the advisory
committee process work.

We have established a tradition in this committee that every time we
hold a meeting at least one of us up here is passing some disease along
to the other people in the committee and today\'s meeting, hopefully
that won\'t be happening.

Also joining us today is USDA Special Assistant to the Secretary for
Biotechnology, Bernice Slutsky, who will be helping us out as well and
will providing a few remarks shortly. We\'re also very happy to be
joined this morning by the Deputy Secretary of Agriculture, Chuck
Conner, who was not yet with USDA at the time of your last meeting.
He\'ll have some words of guidance and welcome for you as well.

We will have a very full agenda so we ask that the meetings and
sessions, conversations need to be limited to those between members. The
public will be invited to participate by providing comments to the
committee and USDA this afternoon between 3:30 and 5:00. Four members of
the public who requested to speak during the public comment period, I
will need hard or electronic copies of your remarks.

We will be providing the Minutes of this meeting and a computer
transcript of the meeting will also be available within a few weeks. We
hope we get the Minutes and all the meeting announcements up on the Web.
The website address for this committee, if you don\'t know it yet, is
www.usda.gov/agencies/biotech/ac21.html.

For any members of the press who may be in attendance, you\'re welcome
to speak to whomever you wish during the breaks of our meeting and
before or after the meeting itself. We ask that you not conduct any
interviews or request comments from members while the AC21 is actually
in session. Dr. Layton, our Chair, and I will be available for questions
and comments at the end of each day of the meeting.

I\'d like to now request that all members of the AC21 as well as all
members of the audience and the press please shut off your cell phones
and beepers while we\'re in the meeting room. Bathrooms are located just
outside this room and to the right. On the side of the room there are
two tables with meeting documents and background documents on them.
Please take only one copy.

For the information of the members of the public let me indicate that
the AC21 has two distinct charges from the Secretary of Agriculture in
its charter. One, examining the long-term impacts of biotechnology on
agriculture and the work of USDA, which the AC21 has interpreted to mean
over the next five to ten years, and addressing pressing specific
biotechnology-related issues identified by the Secretary.

In beginning to fulfill these charters, the AC21 at its last meeting,
with just a few final flourishes added afterward, approved two consensus
reports, one entitled, Preparing for the Future and the other entitled,
Global Traceability and Labeling Requirements for Agricultural
Biotechnology Derived Products: Impacts and Implications for the United
States.

Let me kick off the work of this meeting by congratulating committee
members once again for their hard work, vision, and willingness to work
together and to compromise in comparing and signing off on those
reports. They demonstrate what this committee is capable of which is, we
think, quite a lot.

For members of the public, those two documents are to be found in the
background documents at the tables on the side. They make very
interesting and bulky reading. Further along those lines, let me mention
the other background documents for this meeting. They are, first, the
official AC21 Charter; second, the AC21 By-Laws and Operating
Procedures; third, a package of biographical sketches of all of the
current AC21 members, including our new members; fourth, the draft
meeting summary prepared from the previous, the eighth AC21 meeting held
on February 7th and 8th of this year; and a draft meeting summary from a
meeting held with the four new members to acquaint them with the working
of the Federal Advisory Committees in general and this committee in
particular.

Specific to this meeting, we have just a few official documents. One is
the provisional agenda for this meeting. All of the remaining documents
relate to unfinished work on what has been what we call the large report
on how biotechnology is likely to change agriculture and the work of
USDA over the course of the next five to ten years.

Let me note for members of the public that one of the two reports
recently completed by the committee, the one entitled, Preparing for the
Future, was to have been a chapter of that report, but, was instead
finalized and transmitted to the Secretary after the last meeting as a
stand-alone document. So, a key task of this meeting, which we will
discuss in greater detail as we go along, will be to discuss how to
restructure the remainder of that report in view of that change and in
view of our need to provide the report to the Secretary in a timely
fashion.

So, the remaining documents that I\'m about to mention are all very much
in flux and very much draft documents and they\'re almost \-- and
they\'re all documents that ongoing members have seen many times before.
They are three. One, the most recent draft version of the issues to
consider document. Second, the most recent draft version of a document
that was to have comprised the two introductory chapters for that report
as it had been previously structured. The document contains an outline
for the first chapter and the revised text for the second, and, finally,
a draft definitions list based on the work of the definitions group.

Those are the documents on the official document table. Please note on
the agenda for this meeting that there are breaks scheduled this morning
and afternoon. For members of the public who wish coffee, that coffee, I
think, that we have here is available up at the Starbucks in the lobby
of the hotel around the corner.

Also on the agenda, let me note again that we\'re planning for a period
of up to one and a half hours for public comment between 3:30 and 5:00
p.m. today. We want to be responsive to the needs of the public and
we\'ll see as the meeting progresses how we need to structure that time.

Members of the public, please be sure you have signed up at the door if
you wish to make a comment and you haven\'t already signed up, so we can
plan that time.

Now, from USDA\'s perspective there are four objectives for this
meeting. They are, first, to introduce new members of the AC21. Second,
to provide very brief updates on reports already completed. Third, to
consider how best to complete it in a timely fashion your ongoing work
examining the impacts of ag biotech on American agriculture and USDA
over the next five to ten years.

That is to say, to overhaul our current approach and in that light
consider the status of any current sections of the text that may be
appropriate and discuss how best to finalize text to provide a coherent
report for USDA.

Now, the Secretary, when he met with some members of this committee in
May, and received the two completed reports, indicated his interest that
this work be completed and that work be done by the end of this year.
So, you will need to develop a work plan for completion of that ongoing
work consistent with that time frame and we\'ll provide some ideas on
how to do that a bit later.

And, finally, in terms of objectives, to have some preliminary
discussions of potential future work comments of the committee.

Before I move on, let me just give you a brief status update on a couple
of topics. First, the two reports. The reports you provided to the
Secretary in May have been distributed to the relevant senior USDA
appointees. Both reports have been read with great interest and the
Department thanks you for your clear exposition of the many facets of a
very complex subject in the traceability and labeling report.

With respect to the Preparing for the Future report, the document has
now been brought up in a recent meeting of our Biotechnology Policy
Group, a group at the Deputy Under Secretary level, and they\'re
considering how best for USDA to use the framework you provided to the
Department for future planning.

I think it\'s safe to say though there are a number of members of that
group who see the value of the scenario process as a planning tool and I
will report back when there\'s additional information that I can share
with you.

One additional update that I have is a bit more legalistic and it
relates to the status of members on the AC21. Under federal conflict of
interest regulations individuals who serve on advisory committees fall
into three categories, Regular Government Employees, Special Government
Employees, or Representatives.

Apart from ex-officio members, none of you is a Regular Government
Employee. In consultation with USDA\'s Office of Ethics when this
committee was established, all committee members who are not brand new
to this committee were initially classified as Representatives.
Individuals assumed to represent a particular point of view or group to
the AC21, whether a Representative from industry or business
constituency or NGO. Members classified as Representatives, according to
law, are expected and intended to provide a point of view and be able to
speak for and even bind a particular constituency group they represent
rather than necessarily speak impartially on a subject.

The same is not true of Special Government Employees. Because of this,
standards for impartiality and for financial disclosure for SGE\'s are
more stringent than for Representatives. Last summer new guidance was
published by the Federal Office of Government Ethics that clarified one
relevant fact as to this type of characterization, for Agencies in
general and for Designated Federal Officials, that individuals chosen
for advisory committees, specifically for their technical expertise, may
not necessarily qualify as representatives and may instead more
appropriately be classified as SGE\'s.

In accordance with this clarification, we\'ve gone ahead and
re-evaluated classification of committee members. So, several committee
members from academia, both new and ongoing, are now classified as
Special Government Employees. In the week following this meeting I will
individually notify members as to their classifications and for those of
you who are classified as SGE\'s I\'ll provide you with additional
confidential financial disclosure forms as well as a background of
Federal rules that apply for SGE\'s.

You should not think of this as a big deal, but, I\'ll provide you with
the relevant information shortly. Let me now turn the meeting over to
our Chairman, Dr. Pat Layton, who has some welcoming words for the
committee.

DR. LAYTON: Thank you and welcome everyone. It\'s been a while since
we\'ve seen each other. Some of you we saw in May when we met with the
Secretary, others we saw in March, and it seems like forever.

I\'m going to be brief because it\'s now twelve minutes to nine and we
have \-- that means we have only 38 minutes until he arrives and we want
to make sure that we have plenty of time for his remarks and for all of
us to have a chance to speak with him during the break. To do that, I\'m
going to just say a couple of remarks myself and then I\'m going to ask
each of us to introduce ourselves and briefly give our affiliations so
that our new members who are joining us today, and there are four
members, can spend a little bit more time on yourselves and your
introductions, if you don\'t mind, so it\'s a little bit more about
yourself and why you were interested in joining this committee is one of
the things that we\'d like you to include.

The rest of us will fill you in on that. I hope that the day goes a lot
better. I\'d like to get your remarks out today quickly. To do 18 we
could be here 40 minutes which I think we were the first time, so, I
wanted to make sure we got through all the technicalities we can.

Again, I\'m Pat Layton. I\'m from Clemson University originally and
probably I\'m going to be a professional-government-something-or-other.
And it\'s been a pleasure to work on this committee for the last two
years. I\'ve learned a lot from each of us, from each of the members of
the committee, and I continue to learn and I\'m sure that we all do.

I\'m going to take just two seconds to point out that in reality in
order to get a final report at the completion of the first two years of
work out, we have three meetings scheduled, this meeting, the one in
October, and one in December. Looking at how we worked on the last
report that had the one in December it was pretty much finalizing a
document and getting our own sense of approval and getting our seal of
approval and planning for how we were going to get it out.

So, I take those two days off the table as far as our ability to produce
something. That literally gives us three \-- four days roughly to get
that done here and in fairly short time with this meeting being in
August and the next one being in October. That\'s an intense time for us
to work so I urge everyone on the committee to work as we did in the
last couple of meetings where we were very focused, we were very
diligent. We had an expectation of work to get done and we did it, our
best that followed, I believe, and were able to produce the fine
documents that we were able to get to the Secretary in May.

I think it was an incredible accomplishment to produce those two
documents. One was quite long. One was quite unusual. And I think that
to tell you that both were a very long document that had a lot of
technical material in it and one that was very unusual were very
outstanding of this committee to handle that, to get them done, get them
completed, and pass them out to the Secretary with a total consensus of
opinion on their value.

I am very proud of each of you for doing so and I know that in December
we\'re going to look back and be very proud of the work we\'ve been able
to accomplish in the next four meeting days and then the final two days.

With that, I\'m going to end my remarks for now and turn to \-- you
introduced pretty much the head table, but, Bernice has not been
introduced so I will start with Bernice.

DR. SLUTSKY: I will make this brief. My name is Bernice Slutsky and I am
the Secretary\'s Senior Advisor for Biotechnology. And, first of all, I
want to welcome all the new members and welcome back all the continuing
members and I\'d just like to echo what Michael and Pat just said and
congratulate you on completing the work that you have completed. I can
tell you that both of your reports have been and are continuing to be
read by the Department and then they will be used by the Department.

And we look forward to using your ongoing work as the Secretary said
when some of you met with him in May. And, also, we\'re very excited. We
had to round down the topics in fact that we think will be useful to
this committee so you won\'t be lacking, let\'s put it that way. And we
will be discussing that tomorrow. We\'re really looking forward to that,
so, with that, welcome and we look forward to a very useful and
productive two days of meetings.

MS. SULTON: My name is Cindy Sulton. I am one of the facilitators for
the meeting and I\'m with the company HW&W out of Bethesda, Maryland.

MR. MARYANSKI: I am Jim Maryanski from the Food and Drug Administration.

MR. CORZINE: Good morning. I\'m Leon Corzine. I have a farm in Central
Illinois and I\'m currently serving as President of the National Corn
Growers Association.

DR. VAN EENENNAAM: I\'m Alison Van Eenennaam. I\'m a new member. I\'m
from the University of California at Davis and I guess to tell you a
little bit more than that, my accent\'s Australian\'s for those of you
that were wondering. And I have been in my position as a cooperative
extension specialist in animal biotech and genomics which is basically
an outreach position working with the public and producers on aspects
related to animal biotechnology and I guess that\'s the expertise that I
bring to the committee.

My background is I\'ve got a bachelor of ag science out of the
University of Melbourne and then a masters in animal sciences from USC,
Davis, and then another as a county agent or a farmer advisor as they
call them California with the livestock and dairy industry for a number
of years before going back and getting a Ph.D. in genetics and that\'s
my background.

DR. CRAMER: Hi. I\'m Carole Cramer and I\'m currently in the Arkansas
BioSciences Institute at Arkansas State University. My area of expertise
is in molecular biology and plant-made pharmaceuticals. So, I think that
official card carrying molecular biologist for the committee.

DR. CROWDER: I\'m Dick Crowder with the American Seed Trade Association.

MR. OLSON: Ron Olson. I\'m with the Grain Operations Division for
General Mills.

DR. HUNT: My name is Josephine Hunt and I have another accent for you.
It\'s English, British/English.

(Discussion off the record)

DR. HUNT: I\'m with Kraft Foods. I\'ve been with Kraft Foods for nearly
11 years. Most of that time I\'ve been based in Munich in Germany and
that\'s where I had my first connections to biotechnology where the
European legislation came forward about labeling and so on and so I was
very much involved in that time in setting up methodologies to show
compliance to making regulations and so on.

I\'ve been in the U.S. now for around about one year and I work in the
Global Scientific and Regulatory Affairs Group near Chicago and one of
my topics that I\'m taking care of in that role is biotechnology. Hence,
my interest in this committee. And I\'m very happy to be on the
committee. The reasons being we have an opportunity here to put forward
the opinions of the food industry and also which we couldn\'t afford to
misunderstand, the opinions of the other stakeholders when it comes to
biotechnology.

Now, background. My academic point of view was food science. I have a
degree in food science at the University of Leeds in North England and I
also obtained a Ph.D. there as well. Thank you.

DR. DYKES: Michael Dykes with Monsanto Company, responsible for
government affairs program.

DR. MELLON: I\'m Margaret Mellon. I\'m with the Union of Concerned
Scientists and I am trained as a molecular biologist.

DR. HERDT: I\'m Bob Herdt. I\'m here from Cornell University where I\'ve
been for the last couple of years. Prior to that time I was with the
Rockefeller Foundation, you know, responsible for its work in
agriculture for about 15 years. That includes basically working in the
developing world, about half in Asia, half in Africa. Prior to that I
attended several universities and worked at the World Bank for a short
time. And I guess I\'m here representing the rest of the world.

(Discussion off the record)

DR. HERDT: I know it\'s a small part of our consideration, but, in any
case, the foundation did have a fairly ambitious, although rather
limited, funded program in biotechnology over the period of time I was
there.

And, so, that\'s the background I bring in and a continuing interest in
biotechnology.

MR. SLOCUM: I\'m Jerry Slocum. I farm in the northwestern corner of
Mississippi. I also have four country grain elevators down there in that
area that my family and I own and I\'m responsible for their management
also.

DR. BUSS: I\'m Daryl Buss. I\'m Dean of the School of Veterinary
Medicine at the University of Wisconsin, Madison.

MS. ZANNONI: I\'m Lisa Zannoni and as of yesterday I\'m the head of
Global Regulatory Affairs for Syngenta and I\'m an old rep on the
committee.

MR. SHURDUT: Good morning. I\'m Brad Shurdut with Dow AgroSciences. I
think I\'m the last of the new members. You won\'t hear an accent from
me unless you detect a little bit of a Boston accent there every now and
then. I\'m with Dow AgroSciences located in Washington, D.C. I head up
their government affairs program and regulatory affairs for
biotechnology. At Dow Agro we focus on a really wide array of biotech
from input traits to output traits, to animal health, to
biopharmaceuticals, to renewables.

So, clearly, biotechnology is of interest to me, interest to our
company. I think as biotech evolves it\'s real important that we get a
number of the stakeholders around the table and that\'s why I\'m in
support of this discussion moving forward. My background is really in
environmental health, toxicology area. Then, you know, I have a lot of
degrees to that and I\'ve been in the biotech area for five or six
years; spent a bit of time in the midst of my 15 year career with Dow
Chemical and Dow AgroSciences, with the Health Agricultural Committee.

So, it\'s been kind of broad, so, again, appreciate the opportunity to
be here and thank you.

MS. FOREMAN: Hi. I\'m Carol Tucker Foreman with Consumer Federation of
America. It\'s a membership organization. We have 300 local, state, and
national consumer interest organizations.

MS. GRANT: Hi, everybody. I\'m Kathy Grant from RESOLVE. For all of you
who aren\'t new members, Angela Agosto, who used to take notes and
facilitate, is about to give birth and I am filling in for her.

MS. DILLEY: I\'m Abby Dilley. I\'m with RESOLVE. My voice seems to be
missing which is kind of difficult for a facilitator. But, I\'ll
persevere. Michael referred to me as the designated legion of disease
but I don\'t think I\'m contagious so, hopefully, my voice should come
back over the course of the meeting and I\'ll be able to do my job and
I\'m glad to be here.

DR. SCHECHTMAN: Okay. So we are now a little bit a head of time to my
great amazement and we\'re ready to move on to the second item on our
agenda which is meeting objectives and agenda review and I\'ll turn this
over to \-- oh, I\'m sorry. Dick?

DR. CROWDER: Excuse me, but, before we start it, I\'d like to discuss a
few minutes the rules and what we operate under. Most of you know I sent
an e-mail out suggesting that we look at priorities and so forth. Carol
sent back an e-mail which properly noted that we had agreed to follow a
course of action and I respect that, but, I reflect on the last two
meetings we had at which we had a number of changes and process made,
some structured, some on the fly, some made while some of us were in
another room on the consumer project that morning in terms of how the
final report was made.

I read the notes of the telephone call of new members and I see such
things as working definition of consensus which is not a definition in
itself. And the implication in Carol\'s e-mail, and I accept it, is that
we made a decision and we should go forth with it. And I buy that.

But, I would like to agree that we would buy that and then go back to
the original charter, original bylaws, and stick with those throughout
the process rather than being flexible on one end and not flexible on
the other.

MS. DILLEY: Dick, I\'m not really sure what you mean in terms of how
going back to the original bylaws are different than how we\'ve been
operating. Can you elaborate? Because I\'m being flexible in one way but
not in another. I\'m sorry. I just \-- I don\'t \-- if you could be more
specific.

DR. CROWDER: If I recall correctly the original bylaws said we operate
by consensus. We did not operate by \-- we agreed not to do that with
this working definition of consensus. We established deadlines. You had
to submit your report and state your reason why rather than just a
consensus vote. We made a number of changes in the process as we went
along during the last several meetings that we had.

I have no problem with that. I have no problem with one way or the
other, but, just tell me what \-- tell all of us what the rules are and
let\'s stay with them so we know what they are because we were flexible,
if you will, in our approach. And I have no problem with what Carol sent
back in terms of that. I just think that we ought to have a lightpost
and stay with it rather than moving it around.

MS. DILLEY: Carol, did you have a question or a comment?

MS. FOREMAN: Well, I have a comment, but, I\'m afraid I still don\'t
understand what the problem is with the definition of consensus that we
use, Dick. I\'m sorry, I just don\'t understand.

DR. CROWDER: The consensus has some definition as far as I\'m concerned.
It\'s just consensus. And we have what, and I don\'t know what we
discussed on the other call, a working definition of consensus. It\'s in
the notes from the new members and what a working definition of
consensus is or what versus consensus we \-- the way we proceeded with
the two reports which is different than the way the charter was.

Then we have \-- asked for separate reports. We agreed as a committee. I
have no problem with that. We agreed as a committee that we\'d send two.
We were pretty flexible along the way, but, some of the changes \-- I
know that, Carol, you and I were working on the consumer report. You and
Ron and I think Leon were working on that and we came back in and we got
reported on what the process was going to be at that stage of the game
when we came back into the room.

The process should not change over time and I just think that while we
got a new group, a new start, we ought to agree and just maybe going
back to what the original charter and what the bylaws were is the place
we ought to be to be simple rather than just trying to find another one.

MS. FOREMAN: My comment is that I think you may not have been present at
the point where we first began, I believe it was in December, to discuss
how we were going to move forward with the labeling and traceability and
scenarios chapters and I had expressed great distress that we were going
to send these forward without finishing the issues chapter because I
thought it doomed the issues chapter.

And I received an assurance from the Chair and from the committee that
we would, in fact, have the issues chapter as the first item of business
and we would go forward with it. Had that not happened, I would never
have agreed to go forward with the other two chapters and it was only
out of deference to some of those members who were leaving the committee
that I agreed at the time to go forward without objecting procedurally
which would, I think, then have opened the door for me to object
substantively to some of those things.

MS. DILLEY: I think both of you are emphasizing two different issues.
Dick, I think the issues you\'re raising is that we need to have a
conversation about consensus and how we achieve consensus and how we
move forward during the agenda and what our objectives are and how the
committee\'s going to operate.

We\'ve talked about \-- well, you\'re shaking your head. Tell me if I
have it wrong, but, I think we\'ve talked about consensus in terms of
procedurally trying to operate by consensus as a committee and being on
the same page as to how the process will continue. I think the other
thing in terms of a goal and a final report or a product is that it\'s
not necessarily unanimity but that everybody is comfortable with
ultimately when a document goes forward or is presented to the Secretary
as consensus that everybody has signed off on the document.

So we just talked about a variety of different things with regard to
consensus and what that means procedurally and content-wise, but, I
don\'t \-- I mean, Carol, I think you\'re talking about where we \--
what we talked about in terms of our work plan and agreed to in terms of
what we\'re going to pursue.

Michael, did you want to add?

DR. SCHECHTMAN: I mean, I think if I\'m interpreting at least part of
what you\'re saying, Dick, there I think there were some issues around
procedures for how documents were going to be finalized and what was to
be finalized. Is that the topic that you\'re speaking to?

DR. CROWDER: I\'m speaking to really two things. One, what do we mean by
consensus and, two, once the process is put in place can we change it
because the implications of the way we\'re proceeding as we open this is
that based on the e-mail I sent is that the process was in place and we
cannot review it and we reviewed processes that were in place before,
including what the Secretary asked for in terms of sending forth a
separate document on tracing and labeling.

I have no problem again. We agreed as a group to change that and to do
that. My concern is that we have flexibility at some times and not
flexibility at some times in terms of what the process and agendas are
and I think we need to understand when we start what the rules of the
game are in terms of changing priorities, changing the agenda and so
forth because the implication that I\'ve interpreted it, Carol, and I
don\'t think you were dealing with the process, you were dealing with an
own issue that you wanted to, and I don\'t have a problem with that, is
that once we have something in place we tend to stick with it and it\'s
not up for discussion.

We need to decide whether things are up for discussion in terms of
process by the group, what it takes to change the process, or what\'s up
for discussion, and then what we mean by consensus. Those are the three
things I\'m talking about. I think it would be much clearer to get it
done now than when we get into the middle of some issues and so forth
that we\'re going to be dealing with.

DR. SCHECHTMAN: If I can just reflect back. I think the point of our
need to be much more sensitive to being sure that folks are on board
with changes, now we made a series of changes in the process leading up
to getting those two documents out.

One of them was changing the agendas at each of the last two meetings to
accommodate a lot of time for producing the traceability and labeling
report so the agendas got extremely skewed in the direction of working
on those two reports and at the same time the agenda also got changed as
well on the fly to get the scenarios, Preparing For The Future document
done at the end.

Now, I think it\'s a good point that we will need to be very sensitive
to the views of committee members and that everyone is okay with any
sort of change. I think we need to maintain the ability to have some
flexibility, but, I think your point that we need to be very attentive
to all the members of the committee before we make any of those changes
before we see that everyone is on board before we do that.

In terms of the topic of consensus, I would say that it\'s my fault that
we have the words in there, "a working definition of consensus." I think
we have a definition of what consensus means in the by-laws of how we
use it and I think that\'s intended. There are \-- you know

\-- in terms of procedure on how we get there, I think we have made up
some of that as we go but those are things that are not specifically
spelled out.

You know, the committee was under a very severe deadline to try to get
some documents out before the members departed and to the extent that we
deviated at all from what\'s in there we\'ll need to be more sensitive
to that as we go forward.

I\'m not exactly sure how that could have been done differently, but, I
take your point.

MS. SULTON: Leon?

MR. CORZINE: If I could add, I think what I recall, that change, we were
working on our work group, Carol and I and Dick and I think Ron and I
think Duane and we came back and it had changed. We thought, okay,
we\'ll get this done and then all of a sudden, well, this is kind of
held hostage until we do this. You do what you do to have to finish
things up, but, I guess some of those things I think Dick\'s referring
to, if we can be clear, maybe a little more clear going in.

For example, I wonder if we move forward with the issues draft are we
going to be able to go back and take a look at that because a lot of the
issues change. I mean, even as I was reading what we had already
submitted as far as the scenarios, you know, enough time has passed, a
lot of that isn\'t really relevant as far as a scenario anymore, I
think, but, you will need to go back and take a look at those issues
kind of from the beginning.

I know we have a time constraint, but, that\'s a question too.

DR. SCHECHTMAN: I think that\'s a fair question. We\'re going to go back
and we will actually have a proposal for how to have some chance at
success in producing a document incorporating some information from the
issues pieces that are in various stages from extraordinarily drafty to
somewhat less drafty but virtually all contentious so we need a way to
move forward on that and when we move along on the agenda we\'ll talk
about a proposal for how to do that.

MR. SHURDUT: Just one additional question regarding process. We have at
least four new members here and you went through the consensus process
you put together and you probably closed some sections of a particular
document that you\'re still working on. In the definition of consensus
how will that incorporate the fact that you have new members that really
haven\'t had an opportunity to weigh in previously on some of these
papers or the fact of even whether there\'s merit, you know, to a
particular paper?

DR. SCHECHTMAN: I think the answer to that is, first off, that nothing
is closed at this point except papers that we\'ve already submitted. I
don\'t think there are going to be new scenarios, but, I could be wrong.
And we want to make sure that there\'s an opportunity for new members to
incorporate their ideas as well. That was one of the considerations in
the proposal that we will come to going down the process.

MS. SULTON: Bob?

DR. HERDT: Yeah. Just to be clear. Consensus is achieved when no one
objects. Is that correct?

MS. GRANT: That\'s correct.

DR. HERDT: Okay. So that\'s the definition and I was on the phone call.
I don\'t think I heard any different definition, Dick, in terms \-- I
mean, \--

DR. CROWDER: I was on the phone call \--

DR. HERDT: No, no. No, no. I just wanted to clarify that. I don\'t know
why it was declared as a working definition, but, the definition that I
understand is nobody objects.

MS. SULTON: That is correct. Thank you.

DR. SCHECHTMAN: I\'ll take that as an indication to remove the word
"working" from the draft meeting summary.

MS. SULTON: Okay. Since we\'ve moved to meeting summaries you have the
summary of our last meeting before you. In light of our efforts before
us today if you want to spend time on them; if you have any comments on
changes that need to be made in those Minutes, if it would be all right
for you to please provide them in by e-mail to us within the next week
so that we can finalize those Minutes and post them.

Is that agreeable to everyone? Is there anything that anyone needs to
\-- feels we need to discuss here? Basically that meeting was just
getting those last two reports out as you know. So, if we could, we\'ll
turn now to the agenda for this morning and today.

MS. DILLEY: Michael\'s already talked about the meeting objectives for
the meeting. They\'re note posted on the green handout that\'s at your
table. Just a couple of things. The vast majority of this meeting is \--
picks up on all of those objectives, but, the one that we really are
focusing on is bullet number 3 which is to pick up where we left off
with our work on Issues to Consider relative to the primary charge of
the committee when it was first established two years ago and really to
focus on a vision for the cumulative work that will ultimately conclude
in a document and approach as to how to complete that work and a work
plan to follow that so that, as Michael said, we\'ve got \-- and Pat
referred to \-- we\'ve got two meetings, two additional meetings from
this one to generate and work around the Issues to Consider work and to
submit that document by the end of the year to the Secretary.

So, we will, following the remarks from the Deputy Secretary, will pick
that conversation up and hopefully engage the new committee members and
that\'ll give you a very brief background. You\'ve already had a fair
amount of that background on the call, conference call.

But, just to talk a little bit about that in terms of background and
then a proposed approach for how to re-engage in that discussion, both
drawing on some of the previous discussion as well as acknowledging the
time frame that we\'re working under to complete the work and how best
to do that.

So, we will spend some time doing that up till lunch. Hopefully we\'ll
have a pretty good discussion of the approach as to how to do that and
break for lunch. We do hope that during that time, if we do have any
people who want to comment during the public comment period for this
afternoon that they sign up. We\'ll pick up that conversation when we
come back from lunch and then take a break prior to a public comment
period.

And in the past we have used some of that time, if not all of it, to
continue working if there is no public comment or public comment
doesn\'t take up the full hour and a half, but, we\'ll gauge that and
talk about how to use that time should public comment not fill that time
and adjourn today no later than 5:00 this afternoon.

I\'m usually here. For those of you who are both in and out town some
opportunity for people to get together and go out to dinner together,
so, we\'ll talk about that later. Pat\'s usually taken the lead on that,
so, hopefully we\'ll do that this evening.

Tomorrow we do hope that you will bring your calendars. We referred to
dates in October and December. We\'d like to pin those down as best we
can. We know you\'re all busy people and scheduling you is always a
constant challenge so we hope to at least identify dates that meet with
most of your calendars to be able to designate those dates in advance
and then we\'ll pick up a discussion on the ongoing work and then spend
most of the morning tomorrow continuing developing that approach and
work plan for the ongoing work.

A break for lunch will be followed by a discussion of potential future
committee work which has been referenced, but, we haven\'t talked about
substantively, and then talk about the overall work plan for the
committee and discussion of the next steps and then we\'ll adjourn by
4:00. And hopefully I\'ll have a voice by tomorrow.

Any questions about the agenda overall? Greg? Carol, did you have a
comment on the agenda and then Greg?

MS. FOREMAN: Greg, go ahead.

MS. DILLEY: Okay. Greg.

MR. JAFFE: I\'m Greg Jaffe and I\'m sorry I\'m late this morning but I
got stuck in the Metro for a little while. I guess I was a little
disappointed at the agenda that I got a couple of weeks ago and I guess
I\'d like a better explanation. I see seven hours of spending on
completing ongoing work and now I hear that we mentioned there is a
proposal. I guess I\'m a person who likes to be prepared for meetings
and I feel like I\'m not very well prepared because I wasn\'t given a
lot to think about.

I mean I\'ve been here for two years so I know about our ongoing work,
but, I didn\'t we were going forward and I knew we were at a crossroads
and I guess other agendas and other things have been a lot more detailed
about what we\'re going to do and how we\'re going to spend it. It seems
like this agenda is very, very undefined and it seems like there are
suggested proposals out there and things like that.

And I guess I would ask that at least in future meetings that we be
provided a lot more details about what are going to be done and specific
times and even if things aren\'t set to give us questions to think
about, about ways to move forward here. I know that there were lots of
phone calls, conference calls made with each of us in June to sort of
figure out where we\'re going and we got no summary of what those were
and I expected that in the agenda.

I expected to know in the agenda sort of what people\'s thoughts were,
where we were moving with the issues chapter and I guess when I got this
I was sort of \-- I got our background documents \-- our documents that
we\'ve had that haven\'t changed in a long time told us to review them
and given an outline that sort of says we\'re going to work on ongoing
work for two days.

So, I\'m a little \-- I feel like I\'m not prepared for this meeting and
I\'m going to be asked to address proposals sort of on the cuff when I
could have been prepared and had a week or two to think about things and
I guess I\'d ask in the future for our meetings in October and December
to have really defined agendas. I think if somebody \-- also for the
public. I mean, if the public was looking at this and the public \-- for
the public who wanted to attend this meeting, this provides them no
information whatsoever about what we\'re doing.

MS. DILLEY: I\'ll respond to that. I mean, typically, Greg, you know you
get more detailed agendas than these. It\'s an acknowledgement that we
don\'t know exactly how we\'re going to reconfigure our work and part of
that is what we\'ve talked about already. The last time we discussed the
substance of the issues discussion was almost a year ago, so picking
that back up we\'ve talked to almost all the committee members and
including the new committee members.

We don\'t have a particular \-- we have a plan in terms of how to start
that conversation. We don\'t have a proposal for how exactly we\'re
going to do that. It really requires a discussion by the committee and
because we \-- because we\'re in the place that we are with picking that
work back up after a year of setting aside and incorporate the new
members and having them have an opportunity to get engaged in the
discussions as much as possible we don\'t have a boiler plate proposal
that we know we\'re going to necessarily move forward with.

It\'s something to start the discussion. The committee needs to decide,
as we operate by consensus in terms of our approach, that we need to
have a conversation about how best to do that. We hope that it\'s not
\-- we hope that that approach will not take very much time and that we
can actually get into the substantive discussions over the course of
today and tomorrow. For future agendas it will be much more detailed
because then we\'ll be functioning as a committee that\'s been working
together and has a clear vision of its plan and where we\'re going and
how to get there.

I think the agenda\'s just representative of where we are as a committee
in terms of reconfiguring and reforming our work effort, adding new
members, and getting a game plan that everybody is in agreement with and
move forward. So, it is more vague than we would like it to be as well,
but, it\'s just the nature of where we are as a committee.

MS. FOREMAN: I have a question that I think probably best fits into the
context of the discussion of where we go from here, so, I\'m sorry, tell
me again when we\'re going to discuss that.

MS. DILLEY: We\'re going to set that at ten. I don\'t know if you
anticipate the Deputy will be here at any time.

(Discussion off the record)

MS. DILLEY: So that is where we break and pick it up in full swing.

DR. SCHECHTMAN: Let me just ask whether you meant by where we go from
here in terms of these or in terms of future work after these? In terms
of ongoing work or in terms of future work beyond this ongoing work?

MS. FOREMAN: Well, it\'s a little bit of both. I\'m really referring to
your comment to the new members that the definition of biotechnology did
not include animal cloning because that\'s under FDA, but, then it goes
on to say that an issue can be of interest to the Secretary or influence
his work more than to a member even if it\'s not within USDA\'s legal
purview.

When I joined the committee a year ago, I came in a year after everybody
else, I was told that animal biotechnology generally was not on our
agenda. As we go forward I certainly want to propose that that change.
We have some people here who I think are very interested in that and
I\'m very interested in including cloning in that. So, I was distressed
to read that and I assume that some of these definitions are now open
for reconsideration.

The definition of biotechnology doesn\'t say it excludes that, but, in
your comments you say it does.

DR. SCHECHTMAN: I take your point. I think what I\'d like to do, if
possible, we\'ll note that for now, but, when we get back to talking
about our proposals for future work if we can pick it up at that point
if that\'s okay.

MS. FOREMAN: Well, I think it may enter into the discussion of the
issues as well.

DR. SCHECHTMAN: Okay. If it does we\'ll pick it up at that point if
that\'s okay. I see that we\'re now joined by the Deputy Secretary and
for all of you who have not met him before this is the Deputy Secretary
of Agriculture, Chuck Conner. Welcome. It\'s a pleasure to have you
here.

DR. CONNeR: Bernice, Michael, thank you. Well, again, Bernice and
Michael, thank you for your work in organizing this. I think I see a lot
of familiar faces. Leon, good to see you. Hope you\'re getting a little
rain out there.

MR. CORZINE: A little bit.

DR. CONNER: A little bit, okay, that\'s good to hear. It really is a
pleasure for me to be with you as your Deputy Secretary of Agriculture
now. I\'ve known many of you in other capacities throughout my career
here, but, I think this is the first time I\'ve got to be together with
most of you in this capacity and I am deeply honored to be your Deputy
Secretary of Agriculture as well as deeply honored to be here on
biotechnology issues.

I think most of you know I\'ve got \-- been around the track a few times
on these issues and really look forward to working on them from a
slightly different perspective. Let me just tell you that I think what
you guys are doing is really challenging, difficult work and the
Secretary and I really appreciate what you\'re doing. We appreciate the
experience and expertise and your vision that you bring to this group
and I know and, believe me, I understand that that\'s not necessarily a
consistent vision, but, I think we all, you know, bring our views to the
table and I think we all come here with the desire to be constructive on
behalf of the future of biotechnology and the future of American
agriculture.

We are grateful truly for your willingness to serve American agriculture
in this way. As you guys are well aware, the U.S. Department of
Agriculture is pro-biotech. We believe that biotechnology is an
innovative and powerful tool and it\'s one that we embrace fully as
regulators of this technology and the one that we are going to continue
to support.

USDA activities from research and development, to regulation, to
marketing, and, of course, to our international trade activities
highlight the importance of biotechnology to improving our agricultural
productivity in America.

And let me just say that with regard to this issue of productivity,
Secretary Johanns, who actually has the honor today of being in
Crawford, Texas with the President at an economic summit and he sends
his regards to this group, but, he is doing some interesting things
today with the President, I asked him if he was going to join \-- try
and join me at Three Mile Club today and the Three Mile Club in Crawford
is if you manage to run or walk fast over the course of three miles at
any time in which the humidity is 90 percent and the temperature is 90
percent.

The Secretary said he didn\'t think he was going to try and join the
club. So, anyway, he\'s having a good time today; appreciates you guys
being here and appreciates our activity. One of the things that has been
occupying a great deal of his time is traveling around the country
having farm bill listening sessions where he is attempting to get at a
grass roots level input from farmers and ranchers and other interested
stakeholders on the future of farm bill issues.

And this issue of productivity is coming up a great deal in these farm
bill listening sessions. I think as farmers, you know, at a local level
are beginning to grasp this concept of, you know, what have I got to do
frankly to compete against the Brazilians or the Indians or the Africans
or whatever the case may be, you know, in the future going forward. And
it\'s something we\'ve taken for granted, but, I think farmers are
beginning to tell us that they need to focus upon this.

And certainly biotechnology is one area that I think will play a very
valuable and significant role in our future productivity and
competitiveness as we go forward in this area.

So, your work is very, very important. It\'s worth reflecting on how
much has changed over this period of time that we\'ve truly been
involved in biotechnology which has been really about ten years as
we\'re close to the ten year anniversary of the first introduction of
transgenic soybeans and the planting of those soybeans for commercial
practices so we\'ve been at this about ten years and as biotechnology
has become more important to our agricultural production during this
period the smooth integration into the, what I\'ll call the complexities
of the food and agricultural chain has become, you know, even really,
really much more critical for us.

You\'ve been working hard to identify and analyze some of the challenges
to that smooth integration and helping us, helping USDA, and the U.S.
Government predict some of the challenges that the Department may face
in the future in this regard.

I know that in your discussions themselves there have been many
challenges, but, that is, again, as I indicated, to be expected given
what you\'re wrestling with and given the range of views that are
represented around this table. And as I look around this table I can
tell you guys probably have some interesting discussions.

Michael, just the fact that you\'re here without security detail may
reflect that fact. Many key policymakers and staff, you know, have
already read the two reports you gave the Secretary in May and we\'re
considering how best to use that information and we do thank you for
those reports. We applaud your success in coming again to closure on
those reports given the divergent views that are represented around this
table.

It\'s not every day that, you know, a committee containing this broad
membership can successfully produce a unanimous report and they were
incisive and thought provoking and I\'m not going to tell you I\'ve read
absolutely every word yet. I intend to, but, I\'ve been through a good
portion of both of those reports and they truly are insightful and
thought provoking and we appreciate that.

The Secretary and I are very interested in your ongoing discussions on
what the next step holds for agriculture and for USDA and I hope more
than anything else you come away from this understanding that the
Secretary and I are very interested in the future of American
agriculture and that is, you know, getting reflected in a lot of
different ways, including our farm bill process.

We like to talk about our past. The Secretary and I both have deep, deep
farming roots, but, that\'s really not why we\'re here; that\'s not what
we\'re \-- how we intend to manage the USDA going forward. You know, we
want to be about the future and we want to \-- we truly want to leave
this place in two, three, four years, whatever the President decides for
us in terms of our tenure at USDA, we want to leave it a much better
USDA, a much more future focused USDA than perhaps when we came into
office.

Let me just continue on. The high standard you\'ve set in these reports
makes us look forward to, you know, what you are going to do in the
future. We know you\'re working on some pretty tight timelines in terms
of the, you know, future activity that you\'re on, and, again, we just
encourage you to continue on this.

I also want to, you know, be clear to you that it\'s our view this
committee is not a committee we see dissolving any time soon so if any
of you have thoughts of leaving us shortly, you know, please reconsider
because perhaps a lot of advisory committees we have, and I don\'t want
to sound too disparaging here because our advisory committees play a
very, very important role, but, some, perhaps more than others, I will
tell you that we have more topics that we want you to work on here for
this field that we\'re challenged to look at.

Agricultural biotechnology is advancing rapidly and we just simply need
to stay on top of it and, you know, this committee is one of our means
of doing that because every new advance does pose a dramatic new
challenge for this agency and for our government and for the whole
farming and ranching and processing network.

For USDA that means not only adapting regulations that are science-based
and adapt to these advances in science that we\'re seeing through
biotechnology, but, also helping our farmers and food manufacturers take
advantage of these new technologies, the ones that can be safely used,
the ones that will help our farmers produce crops, we believe, in an
environmentally friendly way, one of the huge, I think, possibilities
out there in terms of biotechnology and enable them to compete in a
worldwide marketplace.

And we\'ve already discussed a little bit about how we\'re seeing more
and more focus upon this notion of competing in the world marketplace.
We\'re seeing more and more biotechnology developments outside the U.S.
as well, in addition to seeing farmers vote through their seed choices.
In many countries in the world, countries like China, Brazil, India,
they\'re all devoting increasing resources to making advances in this
area.

And we can expect to see these biotech products coming into the U.S.,
not, of course, just being exported from us as we\'ve dealt with
primarily up until this point. Sometime soon that\'s probably going to
be a new challenge upon us that we\'re going to see given the
biotechnology activity that is going on in the international
marketplace.

Even in much, much poorer developing countries technology is, of course,
being seen as a key to their future success and particularly the success
of feeding their people. When I spoke to the U.S. Africa Business Summit
just a few weeks ago I noted our commitment to the world to lead by
meeting our duty of helping the world\'s most vulnerable people.

In addition to supporting our own farmers, of course, which is always
fundamental to any USDA agency, we have an explicit goal, and I might
add, probably a humanitarian obligation to provide these technologies
and practices to help the poorest developing countries feed their own
people independently. And, again, I think this is a humanitarian
obligation that we face.

USDA is a major proponent of the science and technology dialogue between
the U.S. and Africa. Secretary Johanns was just there a couple of weeks
ago promoting that and we have \-- I believe we have a great future in
there.

Many of today\'s technologies, including the new biotech varieties, are
coming from scientists in the developing world for producers in the
developing world and this is a significant trend and we believe it\'s a
good trend. It\'s a good trend and something we ought to encourage.

But, let me just close by noting too that our emphasis is not restricted
to the latest and most groundbreaking technologies and I think this is
getting reflected in some of what you\'re looking at in terms of the
future agenda, Bernice and others. Many of the conventional technologies
and systems widely used for decades in the U.S. need to be adapted for
significant productivity gains in the world\'s poorest countries.

And we need to recognize that key to increasing productivity that it\'s
not a new technology of our own but the integration of old and \-- of
new technologies and many old traditional technologies that may date
back for many, many decades, perhaps even centuries ago.

So, we applaud your current work and after your current work is
completed we will look forward to the new projects that you\'re working
on. These are not simply reports to fill space but ones that we\'re
taking very, very seriously as we explore the future of this industry
and we will explore some of these interactions, the co-existence between
the traditional and the new products, and the recommendations on how to
get the greatest benefit for our efforts at USDA so that our producers
and all those involved in this can make the right choices in terms of
new varieties, specialized products that are out there, and the value
that they\'re going to bring both to our own farmers as well as to these
international markets with particular focus on the developing countries.

So, thank you again for your efforts. Know that the Secretary and I are
very, very much hands on participants in the USDA. Our doors are always
open to you, to each one of you, and when I say that I do mean that
literally. If you haven\'t been inside the cage lately you will note
that there\'s been some changes. They\'re just in terms of the makeup of
the Secretary and I\'s office are very, very close to each other. The
doors are always open. Our traffic flows pretty freely between our
offices and that is not just by chance.

That is our effort, I think, to maintain an open door policy so that
people such as yourself have open access to us so that others within
USDA, whether it\'s an Under-Secretary or somebody within the agency
more or less has free access to the people inside the cage so that we
are on top of the day-to-day operation of this Department because we do
intend, hopefully, to leave this Department better managed and a better
place to operate than when we came and that is always a challenge, but,
it\'s one that we take very, very seriously.

So, thank you again for your work and we truly do appreciate all you\'re
doing for us in this area.

DR. SCHECHTMAN: The Deputy Secretary would be happy to answer a few
questions if there are any from members of the committee.

DR. DYKES: First, let me say, Chuck, thanks to what you\'re doing at the
Department and appreciate the job you\'re doing. I also wanted to
comment on some of the other aspects of USDA, namely the Foreign Ag
Service and the APHIS units that Cindy Smith is leading up, the BRS. I
think they\'re both doing a great job of trying to stay on top of new
and changing things and working. The embassy staff around the world is
absolutely critical to what we\'re doing in terms of making sure we\'ve
got market access and the U.S. position is clearly articulated.

So, for that I\'d just like to say thanks on behalf of Monsanto. I guess
the question I have, Chuck, is, as this committee begins our
deliberations and thinking about how we\'re going to do over the next
year or period of time, in your mind what are some of the things that we
could do, Chuck, that would be most helpful to you and the Secretary as
we look ahead to the next five to ten years?

You know the makeup of this committee so I don\'t know if you have any
thoughts on that, but, anything you\'d have we\'d appreciate as to what
you see as being most beneficial to the Department. Thank you.

DR. CONNER: Well, from a \-- just in terms of where I see us going
forward, Michael, and leave it to you guys, I guess, a little bit to
dialogue in terms of how, you know, how and what ways biotechnology
should fit into this, I mean, we are obviously very, very strong
believers in the international marketplace and, you know, you can
imagine where you\'ve been if you sort of haven\'t seen that kind of
demonstrated out in the last two or three weeks with the debate over the
CAFTA legislation.

We believe, you know, it\'s used so often that it almost sounds
rhetorical, but, it is not rhetorical for us in terms of this notion
that, you know, the consumers of the world are not \-- you know \-- are
no longer, you know, housed within our borders and our productivity
gains in the U.S. really, you know, probably with or without
biotechnology, but, certainly aided by biotechnology, our productivity
gains are, you know, outstripping, you know, the U.S. \-- any reasonable
potential for U.S. consumption of agricultural goods.

Our population growth is relatively stable, but, yet, our productivity
gains are really at an all time high and, you know, I don\'t see that
changing in the U.S.; probably wouldn\'t encourage it to change in the
U.S. I mean, if anything, you know, I think the average U.S. consumer is
attempting to reduce their average daily, you know, caloric consumption
and that\'s probably a good thing and, so, just, you know, in terms of
our future we\'ve got to export or else, you know, a massive number of
the people currently involved in what we call our food production system
are just simply going to have to find something else to do.

And that\'s not good either, you know, not only for the producers, but,
for our world communities and, you know, the area, you know, that we
call the middle part of the country, I mean, it just would be
devastating to all of those areas. So, we\'ve got to export and I say
this, you know, sounding a little bit preachy, but, you know, I have all
the frustrations, I understand all the frustrations that come with
exporting, but, there flat out, you know, is not an alternative to that.

And that\'s why, you know, for us the notion of having the CAFTA of
being an absolute must pass, you know, treaty took place. We\'ve got a
huge session coming up in Hong Kong in the Doha round and I really sort
of see that being pivotal. Again, it almost sounds rhetorical given how
many people are talking about it, but, it is pivotal. I mean, it will
determine the shape of the next farm bill. It will determine the future
of American agriculture as we know it, I think, just in terms of
outcome.

And we have great confidence that we\'re going to make progress in that,
so, biotechnology must, you know, fit within this concept of trade and,
you know, the future of trade development. Briefly, in my remarks, we
are truly hearing, you know, at a local level, you know, this issue of
competitiveness has been kicked around now for a number of years by
academia and, you know, people who have traveled to Brazil and come back
and say, wow, you know, you should see all this acreage and all this
kind of stuff and that\'s important insight.

But, you know, I don\'t think that message should really perhaps have
gotten down to the ground level like it is now, or, at least the way,
you know, it\'s coming out in terms of a lot of our farm bill listening
sessions in those forums that we\'re having where, you know, producers
out there, you know, that probably have never been to Brazil certainly
and never had any desire to go to Brazil or places like that are
recognizing that, you know, we\'re in some fairly significant
competition.

And I really think, you know, the future of this committee needs to be
driven as well by the notion that, you know, what we are about is
maintaining our competitive position for U.S. producers as well.

Long answer, but, that\'s kind of \-- Dick?

DR. CROWDER: Again, echo what Michael said, thanks for being with us
this morning and sharing your thoughts. And I also want to echo my
comments, his comments on the Foreign Ag Service. I have spent quite a
bit of time since May from Latin America to Africa to just last week
getting back following the Secretary; well, not following. I was in
China for nine days and people are developing, are changing on
biotechnology, changing their approaches on biotechnology.

There\'s one key issue that you mentioned and I just wonder what, if
there\'s a role for this committee, or, if there\'s a process ongoing in
the U.S. Government to deal with it and if you could elaborate on that
process and that is this issue of biotech being developed in other
countries that\'s going to eventually find its way here.

And I don\'t know that we have a policy for that. I don\'t know how we
deal with it, but, I just know that it is there and it\'s big in
visiting with representatives from Europe, Latin America, Brazil, and so
forth in the last four or five weeks.

What is the process in the U.S. Government, USDA, to anticipate and be
ready for this when it comes? It just doesn\'t show up and we deal with
it in a crisis management type standpoint. And is our role for this
group in there?

DR. CONNER: I think there is a role for you guys in this, Dick, and let
me just kind of share these thoughts with you in general terms and you
guys know that I\'m a candid guy and so I\'m not going to flat out sit
here and, you know, just tell you don\'t worry about it, USDA\'s got \--
you know \-- we\'ve got this one in the bag and, you know, I don\'t do
that.

At the same time too I think there is a lot of work, you know, going on
in this. In general terms, I\'ll just share this thought with you. How
we\'re going to treat this is much the same as we treat, you know, other
imports and other technologies that may be out there, you know, meaning
that first and foremost we are going to be science-based and, you know,
I say that knowing that that, in and of itself, is a controversial
statement because science-based may not necessarily be the most
consumer-based policy.

But, we will, you know, evaluate these technologies based upon science
and, secondly, you know, the President, you know, often says in these
trade situations, you know, we will treat the other countries as we
expect, you know, them to treat us in this trade relationship.

And, you know, that is not to say that, you know, we are not going to
have strong regulatory structures in place, but, at the same time too,
you know, those regulatory structures will be based upon, you know, the
best available science that is out there and it will always be done, you
know, with an eye toward, you know, we will treat those countries in the
same way that if, you know, we not only expect to be treated, but,
frankly, the way we have been treated by some of these other countries,
you know, up until this point as we have been, you know, the innovator
of these technologies and struggled, you know, to keep those
international markets open, you know, during the period of time where we
were the innovators.

And, you know, just because the shoe is on the other foot now doesn\'t
mean that we\'re going to, you know, flip and become the protectionist
element of this. So, in broad regulatory terms, you know, that\'s going
to kind of be the standard by which we will proceed at this point.

And, again, you guys\' input is extremely valuable because, again, I
realize that may be the high level view, but, within that, you know,
there\'s nuances there that are going to need a tremendous amount of
work. And in some cases, you know, products that may not be suitable,
you know, for import into this country and, you know, we\'re going to
need your help as we look and evaluate each of those situations.

MS. SULTON: Margaret.

DR. MELLON: I too would like \--

MR. CONNER: Margaret, are you trying to send me a message there by
putting your name vertically?

DR. MELLON: I\'m sorry. That is the standard signaling your willingness
to speak. I did want to pass on my compliments to you on the job that
Cindy Smith is doing. I think she really is running a first-rate
operation. She\'s got the resources to do it and I think that you all
ought to be very proud of what you\'ve put together there.

My question, I guess, is two-fold. One is that as you\'re going ahead
trying to deal with the problems that now confront USDA whether you\'re
willing to consider new legislation as part of the package of responses
to those problems? And I would give as context, specific context for the
question, my kind of surprise when I read the decisions that came out of
BRS actually approving the farm \-- the planting of pharm crops,
pharma-crops, drug-producing crops in North Carolina.

The decision that document that backed up that approval said that all of
the concerns that have been raised about \-- by Anheuser Busch, by the
rice growers, by folks concerned about our trade and the implications of
contamination for trade, were simply not within their purview. They were
socio-economic concerns and that the agency was unable to take those
economic trade-related concerns into account under the legislation it
currently has.

I mean, my question is, if not under that statute, under which statute
can the USDA address what I think we all agree are ongoing and difficult
\-- I mean, ongoing concerns and difficult issues?

DR. CONNER: Well, it\'s a good question, Margaret, and I appreciate it.
You know, we\'re never \-- you know \-- I\'m not going to say, you know,
definitively that there aren\'t circumstances and, you know, under which
we would, you know, never seek legislation for regulatory authorities in
this area. I don\'t \-- you know \-- I will tell you right now and I say
this, as you guys know, in my previous, you know, position having
chaired, you know, the Biotech Working Group within the White House so,
you know, I had some background in terms of, you know, reviewing these
authorities and reviewing, you know, whether the Administration, you
know, needs additional points.

I would say right now, you know, it\'s not our view that we do. That\'s
not to say that, you know, I couldn\'t be persuaded otherwise and,
certainly, you know, to protect the, you know, safety and integrity of
the food supply, you know, we would not hesitate to seek legislation if
we thought, you know, that that was necessary.

Obviously, the Secretary and I are \-- you know \-- I think you would
describe us as aggressive administrators within USDA and, so, you know,
it would be our view that, you know, if those types of circumstances
arose we would, you know, use the maximum authority that we have within,
you know, the agency to attempt to solve the problem ourself before, you
know, simply throwing it to Congress and, you know, you\'ve been around
this town a long time too, Margaret, and know that seeking legislation,
particularly of this type in the Congress is not, you know, is not
something, you know, the odds-makers would put, you know, great, you
know, great odds of happening.

So, you know, we would obviously first and foremost always prefer to use
our existing authority. You know, in terms of the point that you raised
about, you know, do we have, you know, the authority for the, you know,
what Les Crawford often refers, you know, to in this business as kind of
the yuck factors out there, you know, I\'m not certain I foresee us
seeking legislation, you know, to address, you know, those kinds of
issues out there again.

I mean, if the science is telling us this product is safe and, you know,
that science is clear, you know, from our standpoint, you know, within
this Administration, you know, we\'re going to regulate accordingly
even, you know, even if that\'s something that is, you know, less than
\-- you know \-- has less than desirable effects.

I think we\'ve demonstrated that probably. I\'d be kidding you if I
tried to convince you that I agreed with you given our past track record
for the last five years because we\'ve \-- you know \-- we\'ve survived
some pretty \-- you know \-- pretty rough going, some pretty tough years
in terms of some of these products out there and the consumer acceptance
of them.

So, I\'m not \-- I don\'t see us seeking legislation to address the
particular point that you\'re raising, but, we would not \-- you know
\-- if we felt it was necessary \-- we would not hesitate if we felt it
was necessary to protect the safety and integrity of the food supply
from seeking legislation if we needed it, felt like we needed it.

DR. SCHECHTMAN: Thank you very much, Mr. Deputy. I think what we will do
is take a break. I don\'t if your schedule will allow you to mingle for
a couple of minutes before you head back or if you need to \--

(Discussion off the record)

(Whereupon, a brief recess was taken)

MS. SULTON: Okay. All right, thank you for coming back. We\'ve had a
good break and we are about to start the meeting, but, before we do
that, Michael kind of kicks us off, I want to go over the \-- what we
have is the ground rules for the way we\'re going to interact. Those of
you who were members of the committee two years ago will remember this.
It\'s a nice reminder. And for those of you who are new to the committee
this is just the basic way we function and it works pretty well for us.

First of all, we\'re looking forward to full participation from everyone
in the committee. However, one at a time. So, we will ask for only one
conversation at a time and we will, in order to expedite and make things
productive, at times set some time limits for conversations after we\'ve
pretty much exhausted the point that we want to make.

We will also ask you to honor the agenda acknowledging today that our
agenda is very loose and will be developed in greater specificity as we
go along. Once we have approval we would like to stop the conversation
rather than continue to make the point several times. And we would like
to also ask that people, be free to disagree. We have a wide diversity
of perspectives on the committee from which we would like to benefit,
but, we would like to disagree without being disagreeable. So, we will
focus on the issues and not the persons.

And then we will keep in mind that our ultimate goal is to gain
consensus, to reach some point of agreement on the various issues, some
of which contentious though they may be. So, if we can focus in on those
ground rules, I think we will have a productive effort.

And I\'d like to now turn it over to Michael to take us on to the next
step.

DR. SCHECHTMAN: Okay. We are now returning to the discussions on how to
complete the report, the AC21, since its inception, the report that has
been entitled, Future Impacts of Biotechnology on the Food and
Agriculture System of the United States, A 5 to 10 Year Perspective.

Although portions of this report were largely put on hold at the last
couple of AC21 meetings, it is, I believe, very safe to say that
committee members over the last two years have worked long and hard on
this report. Four facts, and I realize in my remarks here I\'m going to
be making lots of lists, but, four facts are important to note as we
begin discussing how to bring this portion of the AC21\'s work to a
successful close.

First one. As a result of a decision reached at the previous AC21
meeting, one major chapter of this report was removed and presented as a
stand-alone document to the Secretary. That was the Preparing for the
Future report.

Two. Despite the very rich and interesting discussions we\'ve had on
many of the topics, many of the discussions tended to highlight
different points of view of the committee members rather than reveal
areas of potential agreement. So, pursuing the discussions in the same
mode that we\'ve used up until now may very well likely not lead to
consensus.

Texts from most of the remaining chapters that this group has to
consider, sections and even paragraphs are still quite contentious and
not ready for sign off. On some portions of the text consensus may not
even be possible.

Third. At the May meeting with the Secretary, the Secretary of
Agriculture, the Secretary indicated his interest in receiving this
report by the end of this year and we committed to do so.

And, four. We\'ve lost a few committee members and we\'ve gained some
new ones. So, what do these facts together imply? First, we need to
re-evaluate the structure of the report in the light of the removal of
one of its key elements. Second, significant changes in what\'s being
discussed and, in fact, perhaps what the end goal is are necessary in
order to meet the stated deadline.

A number of our continuing members have expressed either to me, or, to
our facilitators, or, the Chair a significant lack of enthusiasm for
continuing down precisely the same path and facing the same difficulties
in achieving consensus on concepts or on language.

Third. New members need to be provided the opportunity to provide their
own new ideas into the mix as the AC21 moves forward. And, fourth, the
USDA needs to ensure that as much as is feasible the group\'s
discussions that the committee has had are captured in some way, either
in the new formulation of this report, or, perhaps in some future
reports.

So, what does all of this lead to? Before I get to that, for the benefit
of members of the public and the new committee members, let me describe
what the format of the draft report has been up until now and then I\'ll
move on to what we would propose.

The report, prior to removal of a chapter, had been divided into four
chapters. Chapter 1 was to be an introductory chapter describing what
the report is and its structure and how and why it was developed and
providing definitions of key terms.

Chapter 2, which was also considered an introductory chapter, was to
have discussed the current and future state of the art which was to
include a very brief history up to the current technology; a brief
description of current products being offered for sale and discussion of
current impacts, including benefits that have arisen from them; a more
general discussion of the overall promise of a technology and a rough
guess as to the kinds of products that are likely to be commercialized
over the next five to ten years based on information received from
technology providers and international organizations.

Now, the draft outline for Chapter 1 and the draft text, the very draft
text from Chapter 2, incidentally, are stapled together in one handout
on the table. Then Chapter 3 was to have discussed issues for the
Secretary and USDA to consider looking into the future.

And, finally, Chapter 4 was to have been the chapter delving into the
uncertainties of the future which was the one extracted and provided to
the Secretary and turned into the document, Preparing for the Future.

So, what do we collectively, USDA working with our Chair and
facilitators, propose as a way forward to enable the committee to meet
its obligations? Let me start with just a couple of proposed assumptions
for this work. First, that we need to ensure that continuing discussions
by the committee are structured in such a way that they encourage
constructive dialogue among members and, where possible, highlight areas
of common ground.

This isn\'t to say that wrestling with very controversial issues isn\'t
a productive and, in fact, an important undertaking for this committee.
In fact, it\'s obviously necessary in order to develop useful insights
and information. However, most of you have engaged in these discussions
for two years and the current format has probably provided roughly as
much insight as it\'s capable of, with the caveat that some issues
haven\'t been talked about in detail owing to the difficulty of moving
along the long list.

So, after that long introduction, these following are the suggestions
for some next steps for completing this report. First. One moment\'s
pause, please. First, reframe the overall work on Issues to Consider as
Topics or Issues Discussed by the AC21. Under that heading, start by
providing a list of roughly single-sentence topics or issues
representing all of those agreed upon for inclusion.

Some of the issues identified on the current list have not been
discussed in detail. So, if they are to be kept on the list it may be
desirable to dedicate a fixed amount of time for discussion of them to
clarify their meaning.

Second. Identify any additional issues for the committee and dedicate a
fixed amount of time frame for discussion and deliberation on them. Both
current and new members should be offered the opportunity to introduce
new topics or issues to this so-called single sentence list.

Third. The committee should consider if there\'s an approach that will
enable the committee to encapsulate more of the substance or flavor of
its discussions on any of the individual topics in a constructive way.
If such an approach is identified it should be discussed here and the
committee should determine how best to proceed with it.

Now, much work was done on a number of issues, among which were the
three most recent; that is to say, adventitious presence, coexistence,
and asynchronous approval and the committee might consider whether it
would be productive to see if some of those efforts on these, or, in
fact, on other issues could be captured in the final report.

As another example, we might suggest that if there\'s time you might
consider continuing discussions to see if it\'s possible to expand on
the one issue near the end of the issues list that currently reads, "The
success of new, more visible agricultural biotechnology derived food
products will be influenced by whether food processors and retailers
embrace these products as adding value to their businesses. Their
decisions will, in turn, be influenced by whether the consuming public
perceives the result in genetically engineered food products as offering
enhanced value such as improved safety, taste, appearance, price, or,
nutrition."

Now, we here thought that those statements in a very broad sense really
captured many of the very interesting and important discussions that
have happened in the past in this committee. So, even though the topic
embodies a fair amount of controversy and hasn\'t gotten as much full
committee attention as some of the other topics, we wanted to at least
commend it to you as maybe worth a second look for possible, at least
small level expansion, time permitting, and if you choose to and are
able to develop additional text beyond the issues statement and are able
to agree on what that might be that might be of some interest to USDA.

Now, I need to emphasize though that for any of this work on issue
expansion, at this point only a very limited amount of time can be
devoted to discussing any single issue. If a way forward is not evident
on a particular issue the so-called single sentence text would need to
be used. And I don\'t specifically mean that it is one sentence. The
issue that I just read actually was, I believe, two sentences.

So, we don\'t need to remove the period for that purpose. But, finally,
develop a report that lists the issues in whatever form is agreed upon
for each and includes some information about the types of products
expected to be seen in the marketplace over the next five to ten years,
plus, of course, a brief description of how the report was developed and
how it evolved into the document that\'s presented.

Note that we are suggesting refocusing this report in several ways in
order to capture a brief record of this committee\'s discussion for most
of what we\'ve called issues, shortening, but, not abandoning them, but,
at the same time recasting them as Topics or Issues Discussed and at the
same time we\'ve proposed significantly shortening the introductory
materials.

Note in addition, as you\'ve heard from the Deputy Secretary, that there
will be future work that will provide an opportunity to delve further
into some of these areas that will have been undoubtedly abbreviated in
this report and we\'ll talk about those topics. We\'re hoping to discuss
those later in the meeting.

Now, this approach is described in the handout that we distributed to
you all and made available to the public. Many committee members were
consulted as we thought about how to get the work back onto this very
accelerated track. We think that this offers at least a balanced and
realistic approach to a framework forward, but, we\'d like to open that
up for your thoughts.

MS. DILLEY: Let me just elaborate while you\'re looking this over. Let
me just elaborate on a couple of points. When you see in black and white
in the proposal it looks much more solid than it actually is and I just
want to talk a little bit about some of the dimensions of that. I mean,
Greg had referred to the fact, and Michael did too, that we consulted,
we tried to talk to everybody on the committee, both current members as
well as new members.

The commonality among everybody is that wanting to fulfill the charge
given to the committee as requested by then-Secretary Veneman and to
complete that as constructively and expeditiously as possible. I mean,
that was Secretary Johanns and made to produce the two reports. It also
committed to completing that charge and his response was, well, I hope
to get that report by the end of the year.

So, we have this extra factor of completing that on an accelerated time
frame. So, on consulting with members I think the common theme was we
want to meet that charge that we\'ve been given and do it in a
constructive a way as possible. Michael\'s also alluded to the fact that
a lot of discussion around these issues are very productive and
insightful in terms of taking advantage of that element of the
committee, that is, the diversity of perspectives that is represented
around the table.

It may not always represent \-- lend itself to finding consensus easily
and exactly, so, one of the thoughts that \-- and I think part of that
is that there isn\'t a common view and I think that during this
particular insight we don\'t all have a common view of what the vision
of agricultural biotechnology is for the five to ten years and part of
that is driving some of the different perspectives and talking past each
other sometimes if there\'s value in some of that discussion.

What I think is the challenge to the committee is to find a constructive
format that people feel is valuable and continuing the deliberations on
the issues to consider, recognizing a lot of things have changed, both
over the course of the deliberations as a whole in the last two years
and having taken one of the key \-- one of the major sections of what
was originally the report, the scenarios piece, out of a document
because we had talked about getting at some of these issues in a
conversation in two ways, doing the issue-spotting and elaborating on
those while also having the scenarios to come at it from a different
angle.

And in extracting that chapter we\'ve changed the configuration of the
report in terms of what we were trying to accomplish. So, one of the
things that people had suggested was, can you think of a concept that\'s
more abbreviated, not cutting short necessarily the discussion,
recognizing that we currently have 18 issues listed when we last left in
September which have had varying degrees of work already done on them
re-massaging that list and the members of the issues committee know that
all too well in terms of lumping and splitting and re-categorizing and
reconfiguring and coming back to the committee with their efforts to do
that and then getting some feedback from the committee and trying
another attempt at doing that.

So, it\'s been a challenge to get our hands around it and doing it in a
way that makes sense to everybody and then proposes a clear path forward
in terms of the work plan. I think what our challenge is today is to
come to some sense of \-- and I think it\'s going to be a matter of
process.

I don\'t think we could write the outline to the report right now and
that\'s not what we\'re asking, but, some sense of the overall
culmination of what these discussions can do in terms of highlighting
what a report might look like and then figuring out a work plan to get
us from where we are now, picking up that work, and integrating new
members and new perspectives into that discussion in a constructive way
that can get us where we need to go by the end of the year in producing
a document to deliver to the Secretary.

So, it does require some discussion and deliberation by the committee in
terms of how to best do that. The proposal that Michael\'s put forward
is an attempt to get that conversation started in terms of maybe a more
abbreviated concept because the path we were on when we last left this
document probably would have been more like a year and a half effort to
give as much time and effort to each of the 18, possibly plus, issues
that we might consider and putting those out in a succinct and coherent
way.

So, we\'re trying to figure out how best to review that list, take note
of what has been discussed and what we can abstract from that, and then
add new ideas and new concepts to some of the issues or new issues that
we haven\'t spent as much time on and come up with an overall vision and
concept for the report and then work on how best to approach this
constructively.

So, we put this forward as a way of kind of starting that conversation
and moving from there.

Mardi?

DR. MELLON: It seems to me that \-- I mean, as one looks at the list of
issues we\'ve talked about, I mean, I\'d certainly be willing to think
about cutting down the list, but, one basis on which to cut down the
list and the discussion of issues in this format is kind of having on
the table what the Secretary wants us to do after this. So, if there are
issues that are going to be addressed later then it may mean that they
are not appropriately addressed in this forum.

So, I mean, I would suggest that it would be important to have an idea
of what else we are going to be asked to do now and that it would help
us kind of inform our decision about how to deal with these lists.

MS. DILLEY: One criteria that maybe could be used or applied to how we
approach this is the future work of the committee. Sorry.

DR. DYKES: Yeah, I was just \-- as I was sitting here thinking about
this, I would share Mardi\'s comments that we kind of know where we\'re
going after this piece it might make more sense to know some of that
stuff could be dealt with in other places, or, at least a more informed
decision and that takes us back to Greg\'s comments earlier this morning
about the agenda.

Most of this stuff we\'re going to have to look at and have some time to
think about because otherwise this is going to be kind of off the cuff
comments.

MS. DILLEY: Other comments, just initially? Dick?

DR. CROWDER: I agree with both what Michael and Mardi have said about
it. I just don\'t know how productive it is to list a set of issues and
then here comes another set of issues that\'s not part of that. So, I
just \-- and I don\'t know how we anticipate without some discussion.

Then a couple of comments. I\'m not so sure our goal is right in what
we\'re trying to do. And I think we need to \-- I think it would be
helpful for us to define what success would be in December because if
you read this and it is a constructive effort in terms of trying to
reach somewhere, but, the goal is to complete a report and I don\'t
think that\'s what our goal is.

Success is not a report. Success is a report that does something, that
says something, and if we look back and reflect on the work that we have
done and the two reports that were successful they had some pretty
well-defined, for lack of a better word, operational objectives. We knew
what we wanted in the tracing and labeling report. We knew what role the
scenarios report was supposed to play. We had a vision of that as a
group and, therefore, all of us could come together and coalesce around
that with different processes and different procedures and changing
things and making it work because we knew where we were going.

I guess my question to Michael and Bernice and maybe to the committee
also, if we stood on December the 19th or whatever it was looking back
at a report, how would we determine if that report were useful and a
successful project rather than just having a report?

And I think we have to look at what we\'re trying to get done and what
will be useful and I think we have to consider what we\'re doing on this
in context of, as Mardi and Michael have said, subsequent steps. We work
better as a group when we are focused on clearly defined objectives and
visions of where we\'re going to go.

And if we could get some definition or some clarity in terms of what the
vision of success would look like if we had this report, but, I think
the goal of completing work on a report is not a very good place to
start, even though I don\'t disagree with the process, but, I think
there\'s a higher goal than completing a report.

DR. SLUTSKY: Well, actually, I think that\'s a really good point. I
mean, the goal isn\'t just to have a report. That is not an end in and
of itself. And I also take what both Mardi and Michael said about, you
know, having an idea of what the next topics will be. I think I guess I
would agree that that would help you in your deliberations.

In terms of what\'s a success, I think to the extent that you could
communicate to the Department at least, you know, what you have
identified as issues that the Department needs to consider as, you know,
a backdrop of, you know, what we will be doing over the next, you know,
five to ten years, I think that that would be extremely helpful to the
Department.

If \-- you know \-- for those issues that you feel that you can expand
upon, I also think that would be helpful. Do I think that you have to
expand on all the issues? No. And because I think in and of itself
knowing that you discussed the specific issues and knowing that you at
least, some of the members of the committee have raised a particular
issue, that tells us that \-- that gives us useful information.

So, I guess my recommendation would be to \-- and I think this is
exactly what you did, for example, is the traceability and labeling
report, is, you know, to let\'s draw a box around what \-- you know \--
what we can do and \-- and not try to sort of spin our wheels just so
\-- just to produce something. And because, you know, what you have here
is useful and I think there are \-- there appear to be some issues where
you can go into more detail because of the nature of the issue and, you
know, you may identify others that you think that you can go into more
detail.

And for the rest of them, I think it is useful to us for us to know that
these are issues \-- I\'m using the word issue a lot here, but, the
topics that, you know, are important to certain segments of the
agricultural system from consumers all the way through, you know, end
products, that\'s important for us to know that those are topics that
have been raised.

So, I don\'t know if you want to add anything, Michael? And we could
also \-- you know \-- I think we would be prepared to discuss, you know,
at least let you know and we can discuss these in more detail later on
in the agenda but at least we can let you know the topics that \-- you
know \-- new topics, new areas of work that we would like you to look
at.

DR. SCHECHTMAN: Yeah, let me just add sort of one thought. This proposal
is, you know, really only the beginnings of a framework. We frankly are
not sure how much text can be agreed upon by committee members on any
one issue. We wanted to provide a mechanism to ensure that all of the
issues that were important to people were captured and to provide the
flexibility for there to be some additional information on topics when
the committee could agree to include that.

We\'re not quite sure how that \-- how far that will go and, frankly,
probably there is not time to have, I would guess, to have any issues
actually go in in the current form at the length that they are in any of
the previous drafts. That would be my guess. I think we\'re looking for,
you know, even if there\'s additional text beyond the so-called single
sentence I would expect that it will be, you know, just an abbreviated,
brief expansion on them and that\'s probably all that we can
realistically hope to get to by the end of this year.

And I think that just to echo what Bernice said, I think that will in
itself be very, very useful. You know, I think painting \-- in some ways
painting the outlines makes it easier to see what\'s important than
sometimes than going into a lot of detail. I know people have looked at
the traceability and labeling report and people who are interested in
the broad outlines have been very grateful for the executive summary and
obviously people who are more in the trenches have read the whole
report.

But, you know, there\'s a lot of detail in it to the extent, I think,
that we can start by focusing on the starting place and then see how far
the committee goes beyond that, that will be useful.

DR. SLUTSKY: If I could just mention one other aspect of this. You know,
we are looking at the report that you provided to us that laid out the
scenarios and, you know, that was a very innovative approach by the
committee. You know, in government, we can try to be innovators
sometimes and we\'re going to try to be innovative and use that \-- you
know \-- use that report and we are looking at as to how we can best do
that.

And I think, you know, laying out, even if it\'s just a listing of
issues, that provides us a good backdrop for looking at, you know, that
report, the scenario report. And I think that will help us as we
determine how we can best use the scenario report. So, in that sense,
even if every issue isn\'t expanded upon in great detail, and, in fact,
you know, it could be so useful that it\'s not expanded upon in great
detail, it gives us a good basis because that\'s really where you all
started too.

And, so, I think that that will be useful to us in using the scenario
report.

DR. BUSS: In reviewing this, it seems as we develop these issues as
multiple, quite detailed in many cases, issue statements we have a lot
of redundancy, if you will. There are six issues alone that use the term
regulatory system and, so, I guess I\'m wondering about trying to look
at this a little more broadly retaining the issue statements, but,
rather than as using them as individual considerations under a smaller
number of topics because it seems that when you read through these,
these do sub-divide into regulatory systems issues which could be
thought of then as bullet statements which might not need any text
whatsoever.

There are some that pertain to marketing, some that pertain to
consumers, and I agree, I think the challenge we get into is less the
issue statements, or, maybe that ought to be considerations for the
agency, adhere to sub-headings under those and the prose is where we get
into a lot of contention and I\'m not sure how necessary or valuable it
is.

DR. SCHECHTMAN: If I can just make one small comment about that. On this
committee we have various lumpers and splitters and we\'ve been through
\-- and we\'ve been through \-- and you know who you are \-- and we\'ve
been through several different iterations of trying to group, un-group,
regroup, sub-group, and I have no problem with doing that, but, I think
it bears noting that that\'s one of the processes we\'ve done several
times already.

DR. BUSS: Well, if I could clarify though. I think what we\'ve sometimes
looked at in the past are combining issue statements or splitting issue
statements. That\'s not what I\'m referring to. I\'m talking about
retaining the issue statements and their individual integrity. But,
instead, logically putting them together because right now it wanders
through issues that pertain to regulatory, to consumers, to something
else.

And, so, I\'m not advocating trying to lump these together into a
smaller number of issue statements but use them as bullet headings under
a topic.

MS. DILLEY: So maybe elaborate on each of those topics, but, then retain
individual statements underneath those.

DR. SCHECHTMAN: If I could suggest that maybe once we get the issue
statements, once there is agreement on the issue statements we can see
how well that works.

MS. DILLEY: Just as a note, Bob, I know you have your hand up, as the
Deputy Secretary noticed Mardi had her card on end, forgot to mention
that for the new members it\'s helpful to keep track of who wants to
talk if you stand your card on end. So, thank you. Bob and then Carol.

DR. HERDT: Thanks very much. I\'m trying to figure this out. I think
that where we are is the committee has done a lot of work. It completed
two papers and sent those to the Secretary. It has two papers in
progress or maybe there are two \-- maybe it\'s one paper with two
pieces, but, anyway, something. There\'s two things.

The proposal, draft proposal, et cetera is, I think, to focus on one of
these, which is the issues, and then there\'s the other one here which
is the future impacts. I don\'t think there\'s anything in the proposal
about future. Maybe I\'m wrong.

MS. DILLEY: It\'s one paper but the issues is one sheet of the future
impacts.

DR. HERDT: Okay. But, the proposal really speaks about the issues, how
to make progress on that.

DR. SCHECHTMAN: If I can just tell you.

DR. HERDT: Yeah, go ahead.

DR. SCHECHTMAN: Let me try to clarify a little. There are three pieces
of text that are what\'s left, if you\'ll permit me to phrase it that
way, of this report on future impacts and the three pieces that exist,
that remain at this point are the chapter that was issues, the piece of
the two introductory chapters which includes the current and future
state of the art and the introduction per se and a piece of definitions
which would also fit into the introduction somewhere.

The proposal talks about shortening the issue piece, also providing a
shortened introduction which would contain only some elements of the
previous long version of the introduction, and we didn\'t mention
definitions, but, using them as needed and perhaps if the document is
quite a bit shorter we wouldn\'t need so many of them.

So, that\'s the sort of general framework, but, it also allows with the
shortening of issues at the same time, you know, the opportunity to
lengthen them once you get past the agreement on what they are and an
agreed upon ground rule that if you can lengthen them in a fixed amount
of time you will and if you can\'t it\'s not going to be productive.

And we certainly take the point that several of you made earlier that
helping to inform that discussion would be very useful to know what the
possible future projects are as well.

DR. HERDT: Okay, good. The structure is good. So the report will have
four chapters if this committee tries to meet the Secretary\'s request
for a report by the end of the year? Because I think that\'s a risk. I
mean, I don\'t \-- then that report has four parts. One is, introductory
chapter which is process, as I see it. Second one is, or, one of the
others is current and future state of the art. Another one is topics or
issues discussed. And the fourth is definition.

DR. LAYTON: Yes. Except the definitions may be integrated into the
introduction in some way.

DR. SCHECHTMAN: And current and future state of the art is also going to
\-- I mean, I don\'t know if that title would still be appropriate if
we\'re proposing to shrink that down to simply talk about the kinds of
things that we\'re expecting to see and not have such a lengthy
discussion.

We\'re trying to cut down as much as possible on all the sections of the
report to make it more possible to reach some consensus.

DR. HERDT: Right, but, this proposal that you just put on the table, is
one page, is dealing with how to deal with the section of this report
that is issues.

MS. DILLEY: That\'s correct.

DR. HERDT: Okay. So, good. I\'m just trying to figure out what we\'re
trying to \-- okay, so, I think that the proposal to try to develop
these which are now very brief statements of issues into what you\'re
characterizing as one sentence statements which, in a way, may be fuller
than one sentence, but, still very brief and not contain a lot of
discussion. I agree with that. I think it\'s the way to go, although I
haven\'t foretaken of all this discussion.

And I further endorse Daryl\'s statement that when they\'re done they
should be structured in some way because it just \-- it\'s kind of like
ping pong. So, short statements of these issues or topics the committee
has discussed and then structure them.

MS. SULTON: Carol and then Greg.

MS. FOREMAN: Before we spend more time, would you please tell us what
the issues are? Because we can\'t have this \-- I can\'t have this
discussion until I know what those are.

MS. SULTON: Greg? Did you want to respond?

DR. SLUTSKY: I\'ll do that for you. I\'m going through \-- I\'m trying
to go through the issues that you have down and at least a couple of
them are specifically related to the two projects that we have discussed
within the Department in terms of what we think would be useful topics
for you to provide us, in one case recommendations on, and in another
case information on.

And I wanted to just let you know, you know, the process that we went
through in the Department because I think it will show that there really
is a lot of interest across the Department on what this committee works
on. We

\-- in the Secretary\'s office we had a list of topics and, as you know,
we have, you know, Biotech Coordinating Committees and we brought these
lists to the Coordinating Committee where virtually, you know, every
Agency in the Department that has, you know, any interest or
responsibilities in this area participate and we got feedback from them
and we also got new topics from them.

And we, you know, went through this process a number of times and then
we whittled those topics down to two topics that, you know, there\'s
interest across the Department on both these topics because they are
crosscutting in the Department.

And the first topic is one where we are asking for recommendations from
the committee and I know that can be difficult from a diverse committee,
but, you know, to the extent that you can give us recommendations we
would \-- that would be of use and I see that you do already have an
issue that\'s very directly related to this topic and that\'s the issue
on minor crops that you have on your list and what our topic, and,
again, we\'ll go into more detail on these, I guess, later in the
agenda, but, it\'s what avenues of technology transfer or actions by
USDA are most likely to result in the production of biotechnology
derived crops, other than large-scale commingled major commodity uses,
i.e., minor crops, or, some call them specialty crops, that would have
the greatest positive economic impact on domestic markets, world
communities, and of the United States, and in developing nations.

So, the focus is on minor crops and what actions USDA can take to
encourage their production. The second topic is, again, directly related
\-- and I have to say we didn\'t look at your list when we developed
these topics so it\'s \-- maybe we should have, but, it is directly
related to your issue that you have expanded upon and that we want
further expansion is on the issue of coexistence.

And more specifically what we would like is a report on the effects in
terms of planting decisions, markets, and rural communities of
coexistence issues on the development and use of specialty crops for
non-food uses and to quality enhanced crops.

So, those are the two issues as we have described them and we can talk
about them in more detail. I think that gives you an idea of the two
areas, at least the two plant areas that we\'ve identified as future
topics and then just to let you know that, you know, in the future we
will be coming to you with a topic on transgenic animals, but, that\'s
farther into the future.

Michael?

DR. DYKES: Could you repeat that last one?

DR. SLUTSKY: Sure.

MS. DILLEY: In terms of while Michael\'s passing that out, the questions
to the committee I think in the context of a couple delving into two to
three topics in the future. You mentioned two on plants and one on
animals. The question, I think, comes back to Dick\'s question of the
goal is not to produce a report, it\'s a report that may provide those
issues that constitute the backdrop against which USDA is trying to do
its work over the next five to ten years.

And I think the question that we\'ve been wrestling with is beyond
listing those issues that everybody on the committee could identify
individually on its own is there value to deliberating further on those
lists of issues, or, categories of issues that can provide some
additional insight to the Secretary and to the Department that could
help guide how we would approach a final report and structure our
deliberations on those issues from now until completing the report.

So, we have over the course of the two years identified issues and have
used criteria to put a broad set of issues on the table and now the
question is really where do we go from here to add value to those
discussions and thinking about those issues for the Department.

Greg, you had a comment or question while these are being circulated?
They may not be specifically on future topics, but, no?

MR. JAFFE: Well, it wasn\'t on the future topics. I need to think about
those before I respond to those. But, it was on sort of where we go from
here on issues or whatever and what I think is interesting about what we
just sent out is it would be nice to remind us all of what the issue
statement is or what the scope of what the original report was supposed
to be because we have all these chapters but it\'s been so many years
I\'d like to go back and sort of see what that original statement is.

I think it sort of gets to some of Dick\'s question, what are we trying
to answer here as opposed to just writing a report. I think that would
be something valuable to maybe pass out later today, or, at lunchtime,
or, something is go back and find out what was the original \-- where
that charge is or what is \-- what is the question that is being asked
by the Secretary\'s office for this report that we\'re talking about
this morning?

That would be helpful, I think. But, I think, I mean, in my mind what
was good about the labeling and traceability report and the scenarios
one was we gathered on the expertise that was around the table and we
added value to something and I think those are two things to keep in
mind both on these new topics, but, also for the report that we\'re
talking about here.

There are parts of the proposal that I like, the draft proposal here. I
never thought that this committee\'s expertise was in talking about what
the future of these products are. The people around the table are policy
people. They\'re not scientists. We weren\'t the people who would be
able to tell. We brought some people in and we wrote something, but,
that wasn\'t in our area of expertise, and, so, I don\'t think have a
lot in any report on that is of value.

So, I\'d like the part of the report that sort of limits discussion in
the future similarly talking about the benefits and things like that.
Again, that wasn\'t something people around here had \-- we sort of
looked to outsiders to talk about. I think we\'re better off sticking to
a smaller report that really sets the value of this committee, which is
having the range of stakeholders throughout the food chain talking about
implications of different aspects of biotechnology.

So, I like that aspect of this that sort of cuts down some of those. I
don\'t look at this as four chapters. I think it\'s hard for committees
to write long reports. I think global traceability and labeling was
unique because we had a lot of facts and we had a sub-committee that had
people with some very good knowledge.

But, I think if we start writing a long report with four chapters in it
we\'ll never get it done. I like to think of what we\'re doing as a
paper. Preparing For The Future was a paper and this would be another
paper, 10 or 15 pages that would put some background together, an
introduction, and then have some discussion without lots of chapters,
without lots of definitions and so forth and concentrate on the things
that are the value that this committee can add.

So, I think having been through two years of brainstorming and back and
forth with lumping and not lumping and everything about these kinds of
things I\'m not averse to having shorter statements about them. I am a
little concerned about shorter statements about some and bigger
discussions about others because I tend to think we all, we all forget
the ones that are the least controversial and therefore it gives the
wrong impression to both the Secretary\'s office and to the public that
these are the ones that have \-- that are more important because we
wrote more about them when, in fact, they tend to be the ones that have
the least common denominator.

The ones that are the easiest to write about and the ones that are
actually the most important to different stakeholders don\'t get
discussed. So, I\'m of the impression that whatever we decide, things
should be of equal length and equal priorities and, in fact, we\'ve in
the past not ranked things. Because of that problem of ranking them and
just listed them I think it\'s better to do that.

I think I don\'t have a problem with it if there\'s one or two of those
topics they\'re proposing to the Secretary we write a five page separate
paper about those that\'s submitted separately as just a thought piece
on a given topic or two. That might be a way to get around that if
there\'s one or two that\'s important to everybody and we can get
defenses around it.

But, I\'m uncomfortable putting into one report things that are very
different, very uneven, because I think it does give a different message
than I think the message we want to provide. But, I think part of that
message has to go back to what are the issues that we\'re talking about.

DR. HUNT: I thought it might be useful to give a perspective from
somebody coming new to the group after having read the chapters. My
first question was, and I\'m hearing this around the table again now,
what exactly are we trying to achieve with these two chapters? It
wasn\'t that clear to me and I think very important to define before we
go further really what the scope of these documents are, what it is we
hope to achieve at the end, more or less what Greg just said as well.

And the chapter where you\'re putting down the state of the art and I
think it would be a good idea to reduce it. I think that\'s what people
are suggesting now. And to have it much more structured and then these
state of the art points that are put in that section of the report
reflect then the issues that we cover.

MS. DILLEY: Just in terms of people for the language in the original
charter and I believe it was to identify issues associated with future
agricultural biotechnology products, so, as far as that outline in terms
of what are the future biotechnology products \-- God, sorry \-- and the
time frame was determined to be five to ten years to define future and
then identify what those issues are so that kind of gives you whether
it\'s a paper or different chapters.

(Discussion off the record)

DR. SCHECHTMAN: Yeah, I\'d lend you my voice box if I could. I think
it\'s worth pointing out, certainly for the new members, that there was
a lot of \-- that the structure of the report has been something that
was configured and reconfigured and reconfigured a whole number of times
trying to figure out how to get a handle on what was initially a fairly
amorphous charge.

And, so, we are \-- you know \-- it\'s not been set in stone, so,
that\'s why the proposal was to try to see if we could reduce it to its
elements that would yield a brief and coherent report.

So, the point that you make about linking issues to expected product is
something I think the group would make sense to bear in mind as they
look at the text. At the same time, I think, you know, there\'s sort of
been an attempt to try to balance all the various different pieces.
There are a number of the issues got a great deal of discussion and a
number of the issues didn\'t get very much discussion in the room and
that\'s because once we got started on some other issues they took a
whole lot of time and they were not necessarily completely resolved.

And I think Greg made a very useful point about not wanting to leave the
impression that some issues are more important than others just because
the committee can agree more easily on the text. And I think it points
out the fact that it may be that everyone\'s going to decide we just
want to leave it at sentences, or, you know, one or two sentences to
define the issue.

But, even if that isn\'t the final discussion, I think we\'re not
talking about not having some issues being three pages and some issues
being one sentence. I don\'t think that is in the realm of what we were
thinking about anyway, but, your point is certainly really well taken.
That\'s something that, I think, we will need to \-- that\'s something
that you should consider carefully.

DR. CROWDER: I think one thing we\'ve heard is that short is better and
I agree with Greg on also on the weighting issue, weighting question.

Mike, when you used the term early this morning that I think might have
some merit in considering going forward in terms of reaching something
that we can consider useful, particularly given Bernice\'s comments on
what would be useful, just, okay, what had you discussed, maybe we
should take the word issue off the table and put topics of discussion.

Okay. This is what we\'ve talked about that should be considered in the
formulation of policy and just enumerate what was discussed and stop it
there. Because one of the things we had a problem with to start with is
I would say it\'s an issue and Carol would say it\'s not an issue and
then we\'d go back and forth. But, if we just said, okay, these were
topics that this group discussed as related to this charge and make it
an enumeration rather than a discussion and let the policymakers at USDA
decide that.

And, Greg, this could go into the benefits side also. These were topics
that were discussed and I believe there\'s a longer section in there on
those than the write-up is on issues and just say these were topics for
discussion and just let it be at that if that would be useful and
that\'s what I heard earlier. Maybe I mis\-- maybe I misinterpreted what
Bernice was saying, but, that might help us move along maybe by just
changing our terminology.

MS. FOREMAN: I think it would help to remember some of the old members
of the committee if they had access to all of the write-up of each of
these things because then you would have a flavor for how long and we
know that we don\'t want to go forward with that.

As it is, we have the lengthy write-ups for the ones where we had
discussion and nothing but the statement for those where we didn\'t. And
the problem is we have had no discussion and we can\'t say right now
there were topics of discussion because except for our work group where
we chewed over them at great length in the middle of the summer in a hot
room at USDA they haven\'t been subjects of discussion.

And they have been brought up in some of the presentations that have
been made to us, but, each time we\'ve gotten around to looking like we
were going to discuss the consumer issues, for example, we do something
else and it doesn\'t happen. I\'ve been on the committee for over a year
now. We still haven\'t had any discussion of these, although at each
meeting it says oh, we\'re going to get around to that one of these
days.

So, that\'s \-- I don\'t think the new topics help us very much get
through this. I really feel like the products will not be successful in
the long term if people will not buy them and use them. We now have
expertise, additional expertise on the committee from the processing
companies that have to purchase these crops and turn them into food
products that people will buy and I think that it would be worthwhile
having a conversation about what is necessary, not just for approval,
but, for consumer acceptance of new and more visible products.

DR. SCHECHTMAN: I take your suggestion, Carol, and we are, in fact,
prepared to distribute the versions of the rest of the text, but, I
wanted to introduce that before we actually did it because the work
group members, as I recall, did not feel that those texts were actually
yet ready for prime time so I want to distribute them solely on the
basis of indicating that they are background materials. I would say you
wouldn\'t even call them necessarily draft texts.

But, just to give people a flavor of what the materials were that were
developed so that they can see what some of the discussion was on the
various topics that are listed as one sentence. The document that I have
that I can pass out that has those in them looks just a little bit
different than the last lengthy version of that that you saw in the
issues group.

All that I did was eliminate all of the pages of struck-out text and
indicate where for the three issues that are in the other document that
you received, instead of having older versions of them left behind in
this one, I just said, see the other document. But, I have that version
and that will at least provide a little bit of background information to
other members that can see at least where those individual issues were
coming from by at least, from at least the person who was writing them
up, if that\'s agreeable to the rest of the committee. Any problem?

DR. DYKES: I\'m not clear then what you have that you\'re passing out.
If it doesn\'t have previous text and if it doesn\'t \-- and the things
that we have written up here you\'re just saying refer to them, then if
it\'s not previous text what is it?

DR. SCHECHTMAN: No, no, it has all of the texts that existed in the work
group for the other issues, okay, but, not intended, you know, since
those things were not necessarily felt to be ready for prime time to be
discussed as texts and since at this point we\'re not actually \--
perhaps I should rephrase that.

MS. FOREMAN: Most of what was deleted were places where we had worked
combined issues and so the separate answers or the separate statements
were no longer appropriate. And, as I understand it, what you have is
only the last go around of what we had brought to the work group, what
each of us had brought to the work group. There\'s absolutely no
agreement in the work group. I agree with Michael on it.

But, people could see, among other things could see what a problem
exists here in trying to reach some agreement.

DR. SCHECHTMAN: The intent of this is not to try to advance any of those
texts specifically. It is to provide specifically for new members just a
little bit of flesh on what the issue was to the person who thought it
was important and wrote it up. Just so at least for those issues that
are there and only one sentence they can see \-- they can see where it
came from.

We\'re not proposing that that text be included in the report. It\'s
background. It\'s a proposal just that it be seen as background
information.

MS. DILLEY: A little history of the discussions of the committee is more
or less if we are to go this route of listing them as topics of
discussion to Carol\'s point, some of them had been discussed and some
of them haven\'t. So, one of the things we would need to do is go
through the inventory of the issues and figure out how best to approach
those to get to the shortened version of each one.

And it gives you a little bit of that history of the various issues that
we\'ve been talking about.

Greg, is your card up? Okay.

MR. JAFFE: I mean, I find that that document \-- my memory of that
document is that it is \-- not only is it the committee didn\'t agree to
it or the sub-committee, the work group didn\'t agree to those things,
but, even some of those issues there were on their second or third total
re-writes. So, we\'re only showing people one of the writings of those
issues that, at least for some of those, I remember writing a draft a
year earlier than that that was totally thrown out and somebody else
then re-wrote it.

So, I also don\'t want people to think that this was the only crack at
this one. There were other reiterations of those same write-ups, I
think, even as early as a year earlier. So, this is just one, I would
say just one snapshot in time. If you really wanted people to get a
total flavor you\'d have to show them all the other ones or the
brainstorming sessions.

But, I think \-- I mean, I think it\'s valuable that they\'re handed
out, but, I just want people to understand that some of these have been
\-- went through several reiterations before this one.

MS. SULTON: Michael?

DR. DYKES: I\'d just like to add about Greg\'s comments and that\'s all
I was asking because I wasn\'t thoroughly passing out so it is clearly
one snapshot in time and I even not opposed to that fashion but I
question what the real value of going back and digging through all that
is. I mean, I know what Carol\'s trying to say, it\'ll help people
understand what the discussion\'s been, but, by so doing we\'re only
giving them one snapshot or part of a two year long discussion.

And I, too, wrote some of those three different times and I\'m not sure
they\'re even reflected in the last document so I question the real
value of that approach.

MS. SULTON: Leon?

MR. CORZINE: I guess I have a little frustration in that too that, you
know, you can\'t go back though with all the discussion. For example,
for the record, Carol\'s comment on consumers. She\'s done a very good
job getting consumer component in each part. I would disagree that we
haven\'t addressed any of the consumer things because our work group
finishing up on labeling and traceability, we went to your \-- battery
went down on your computer, Carol, even trying to get through and spent
a lot of time on the consumer part and I don\'t know how you capture
that for the reflection or historic part for the entire group.

I don\'t \-- you know \-- we about have to go with that snapshot and
move on. I don\'t see how you do it any other way.

MS. DILLEY: Well, I think the basic question is how much more history do
you need to be able to move forward and not rehash the same ground, but,
get to a point that we\'re on a track that\'s productive and producing a
report and have a constructive discussion. So, that\'s what we\'re
trying to sort through. Carol and then Michael.

MS. FOREMAN: Well, I\'m specifically referring to this issues chapter
where we have never gotten to the consumer issues in this chapter as a
\-- in a plenary session. They have never had that discussion. The
reason that we had to go sit in the USDA cafeteria and run down the
battery on my computer at the very last moment was that the committee
had never discussed what the consumer issues are, the issues for
American consumers in labeling and traceability.

And it was only in a last minute effort to remedy that that we ended up
in the USDA cafeteria. I\'m trying to make sure that we don\'t get in
that situation again.

DR. DYKES: It seems to me that we have two things that we\'re looking at
here. I thought I heard a proposal, and it gets back to a question, Dick
raised it up, you know, what are we trying to accomplish. But, if we are
looking at now to December to issue something, a paper \-- I\'m more of
where Greg is \-- a paper, if we\'re to issue something to kind of \--
if we want to, for lack of a better way, say kind of clean out where we
have been before we take on, tackle new proposals, either through
Bernice, Dave, or whatever, however we want to go forward, we\'ve got
two different phases as I see it.

We\'ve got between now and December to kind of close out on any kind of
pending stuff that\'s there. To Carol\'s point, some of the stuff on
issues, topics to be discussed, this other chapter. How do we want to
put that? It seems like what I\'m hearing is that we have \-- we also
have a proposal that we take what we have here and maybe shorten this
chapter on whatever it\'s called, the introduction or the future
technologies.

And, then the other proposal is we look at the issues, and to Greg\'s
comment, we don\'t have some of them with a three page write-up and
others are just the one sentence, we look at all those and maybe we try
to come around at least put them down as topics that were discussed in
their one sentence format so that it\'s clear to whoever in the
Department is taking this, these were things that were on the minds of
the committee members that need to be addressed by policymakers inside
the Department; needs to take a look at.

And there are topics and, hopefully, to Josephine\'s comment, those
topics will relate to what we have in the other text as preparing for
the future and some of those kinds of things. So, I\'m kind of where
Carol is. I don\'t know that these other two new topics are necessarily
going to take any of the topics off the table per se. I mean, we\'ve got
some stuff about minor crops. But, I think if we have them into one
sentence formats they\'re not mutually exclusive.

So, my thought would be is if we\'re going to try to look at the next
six meeting days as productive, we try to get our mind around is are we
comfortable taking what text we have and preparing the \-- what in the
world do we call it \-- we\'re talking about what the technologies of
the future, what the technologies are going to do, looking at that.
Maybe that\'s longer than we now want it to be. I don\'t know.

And then we look at adding to that one sentence kind of thing that\'s
about topics that were discussed and then we include a definitions
chapter of what pieces out of the current definitions thing is relevant
and so I object if it comes to Dick\'s question, not necessarily to do
or to die, but, just to finish \-- check the box that we\'re going to
finish that report before we move on without ascribing any kind of
values to what the value of that is other than we\'re going to do it,
that\'s what we have, that\'s what\'s pending, and we\'re going to kind
of clean out before we start on something new.

Is that \-- are others of the same mind? Is that what others are
hearing?

DR. SCHECHTMAN: Mardi?

DR. MELLON: Well, without \-- I mean, I guess I hope we don\'t do that.
I think we\'re an expensive assemblage of folks to the taxpayers and
there has to be something of genuine value that we can offer to the USDA
that, you know, isn\'t just checking the box.

Now, so, I guess I \-- you know \-- I wouldn\'t want to think that we\'d
walk away and say we\'re going to come up with ten issue statements and
we all agree on them and then we hand in a report because I don\'t think
anybody will care what the ten issue statements are.

So, I mean, my thought is that, you know, it would be better to address
in some \-- you know \-- in some honest and helpful way some of the
issues that we have run around the maypole on in this issues discussion.
I want to second what Carol said that, you know, I was not on the issues
committee so basically I don\'t \-- I represent that part of the
committee that really doesn\'t think that we have looked at a lot of
these issues.

I was over there doing scenarios. So, I mean, I can\'t help but think
that there is value to us addressing \-- even if we can\'t come to
consensus \-- and I mean, I don\'t think any of us think that we really
would come to consensus on a recommendation, but, at least in terms of a
description of what \-- you know \-- of one or, you know, of some of
these issues in a way that would be helpful to the Department.

I mean, that would let them kind of know what, you know, we would have
articulated the issue, what\'s out there, why some people feel so
differently about the issue raised in ways that they might use. And I
also would say that the 800 pound gorilla in the room is regulation and
it is the consumer issues and to kind of take on something that
diminishes them to the point that they\'re not out there at all, again,
I just don\'t think it\'s a service. That\'s not why they put us
together.

DR. SCHECHTMAN: A couple of points about that, Mardi. I can see \-- I
disagree a little in thinking that the single issue statements by
themselves would not be useful. But, at the same time I think it\'s the
first step. I think that there was not, in fact, agreement up until this
point for all of the issue statements about precisely how they were
worded so that one of the things that needs to be done back over is
checking to make sure that everyone is in agreement and modifying the
issue statements themselves to make sure that we have a set of issue
statements.

If there\'s to be expansion beyond that, you know, part of that is
dictated by how difficult all of the tasks on this report have proven to
be, a little more difficult than we had initially thought. So, we have
to \-- we have to repeatedly go back through the process and see what
the possible is.

It would be good to provide the streamlined material. It would be good
if all the topics could be expanded a little bit, but, I think we have
to repeatedly through this process over the next few months see, you
know, what is actually going to be possible as the group moves along.

I should just clarify one thing about the document that Carol had
mentioned and that I had mentioned here that really since part of that,
the thought about providing those old snapshots was purely \-- was
specifically in addition because of the fact that the wording of the
text was not yet agreed upon for those; that that at least helped
understand where they were coming from; not because we thought the text
was going to go into the \--

MS. DILLEY: Can I just to comment? Bob\'s card is up and it looks like
Dick wants to talk to you. I think honestly the challenge to the
committee is the topics of discussion, when have we reached that
threshold and, Mardi, you\'re pointing out the value of the discussion
itself. And some of the issues have been discussed pretty extensively in
the group, but, not in the full committee.

So, we need to go through the list and can allocate our time as to how
\-- what we need to do to table that discussion and have it that\'s
constructive and useful to provide the insights to USDA and to each
other recognizing that a lot of that\'s not going to end up in a final
report; that ultimately the product may be much smaller than the
deliberations themselves and the value around those deliberations; but
that the final product may be much more streamlined and minimalist as
opposed to capturing the richness of the discussion. Sorry.

Bob and then Dick.

DR. HERDT: I think the other new members would agree that we\'ve had
enough \-- we\'re on the committee because we\'ve been exposed to these
issues enough that we don\'t want to see all the words. You know, we
don\'t need that because we\'ve read these words in so many different
forms. Okay.

I think what we should do is \-- I mean, I think we do need \-- what I
would \-- I think what the proposal is on the table is agree on the
wording. I think we ought to try to agree on the wording of these issues
as one sentence or two sentences, you know, the short version so that we
as a committee look at each one of these things and say, that\'s an
issue or a topic that we are concerned about.

And we also need to be careful that we get on the table, on the list, if
you want, any additional such issues or topics. And maybe that\'s where
we have to follow this process of a time limit to say, okay, we\'re
going to spend the next half hour on this, let\'s try to get it nailed
down. If we can agree on the wording at the end of a half hour we\'ll go
ahead. If we don\'t we\'ll have to come back to it at some time.

And, so, we can use our time and discuss it and then somehow divide up
into work groups or something for the fuller discussion and we come back
and we agree on that. Otherwise, we\'re going to discuss the process for
the next day.

DR. CROWDER: I\'d like to go back to a point I made earlier based on the
discussion and then on Mardi\'s comments and where they might take us
and I don\'t disagree that a full discussion of the issues, or, topics
is a word I prefer, would not be useful.

But, my question is, is it practical given the time constraints? And,
again, if we look at what the report is going to be or what we can
possibly agree on in terms of the report, just one person\'s opinion in
terms of how I come to where I am and it\'s triggered by Greg\'s, in
short, paper and so forth, and it also by what Bernice said that just
our thoughts on what\'s important, what the important topics would be
important to the Secretary, I think that \-- and, Carol, I may have used
the wrong word in terms of topics discussed; it could be topics
identified, something we haven\'t discussed. Sometimes we\'re not
precise enough in our English.

But, if we say what \-- if something is useful to the Secretary what is
the best we can give. What I think we can give a list of topics to
discuss benefits, what has been called benefits, what has been called
issues, and I think that\'s if we visualize what that\'s going to be
then we come back and say, okay, how do I get there and what do I need
to get there?

I don\'t need a full discussion and a drafting of all the comments
around the issues to get there. So, I think we ought to at some point go
back to the paper that Michael outlined and also back to what we think
might be useful and what we can get to and then let the process best get
into that.

And the last thing I was going to make, I was not involved on this
issues discussion either and I guess my question is, what am I suppose
to do with it when I get it and, secondly, how am I supposed to use it?
Not that I wouldn\'t find it interesting, but, as it relates to how we
go forward how am I supposed to use it because I\'ve not been involved
in that one either?

DR. SCHECHTMAN: Yeah. I mean, I think members of the committee certainly
there was a discussion as we moved along in terms of when there was the
full committee issue-spotting process there was a little bit of
discussion around each of the topics that was mentioned as it made it on
to the list so that for current members of \-- for members of the
committee who were ongoing, they\'ve probably heard a little bit and
understand at least a little bit. sometimes a lot depending on the
issue, but, understand the context from which each of the issues came to
some degree.

I think the same is not necessarily true for the new members and there
is perhaps a value in just seeing this entirely as background. Maybe it
can help shorten a little bit of a discussion when the wording \-- when
the group is as a whole trying to sit down and figure out what the right
words are for the particular issue; not that it has any other status
particularly, just that it may be an informative background piece.

MS. SULTON: Ron?

MR. OLSON: I just wanted to kind of second what Dick said and Mike said.
If you want to pass it out that\'s fine and we can choose to read it or
not if we want to so we\'re all familiar with the issues and have our
opinions on them. But, we do a thing at work where we have kind of a 20
minute version and a three minute version and a 30 second version
depending where you\'re going and it seems like we need the three minute
version because we got the 30 second version just by listening to issues
or listening, what do we call them, discussed, identified, whatever,
doesn\'t make any difference.

But, what we need is three or four or five what the key points under
those and just try to get those down as opposed to what we\'ve written
on the others as a 30 minute version or we\'re trying to persuade
somebody. And what I hear from Bernice, and when Chuck talked as well,
is we want you just to tell us if you think this issue is there and what
are the key points around it rather than ask for more debate or more
feedback if we need it.

But, I would rather just get started on the process and let\'s just tee
one up and put down three or four pluses, what do they call them, pluses
or minuses, or, lead-ins or whatever you want to call them, just get
them identified and we don\'t need to persuade each other that it\'s
important to you individually. It\'s just an issue and what are the key
points around it and let\'s just go.

MS. SULTON: Daryl?

DR. BUSS: I would agree with Ron\'s approach. I think also as we do that
though we need to think a little bit about the intent of the report that
we\'re providing and maybe a different way to look at it is to provide a
very concise bullet-oriented report, if you will, but, in the context of
providing that to the Secretary to react to and then if there are
elements of that individual considerations that we\'ve listed as bullets
on which the agency would like more amplification then that\'s a useful
exercise, then let\'s get into it and do the three hour version if
necessary.

If not, then why develop these\-- are we sort of going about as
individual expositions in their own right. It doesn\'t serve us well in
terms of time or anything else. So, I think if we look at it from the
standpoint of providing enough detail so that there\'s clarity in what
the issue really means in our view or what the consideration is then I
think we\'d be much better served.

MS. DILLEY: Any other comments? It\'s almost lunchtime. I\'d like to
propose on the table actually that the way to get going on this is jump
into the issues and just take that list of issues. People want to pick
up the document on extra background do that. If not, fine. But, then
start when we come back from lunch. We may be even working backward
through the list because I think for five items on the list are the ones
that we have 30 seconds level as opposed to the three minute and see if
we can catch it up and work more towards the three minute on that and
then we can get to the other ones in a much more formal text later.

Because I think we have not gone to those issues as thoroughly so if
people are in agreement, I see nodding heads, some of you may still be
confused as to what we\'re trying to do but I think we\'ve got a sense
of where we need to at least get started and then view how that\'s
tracking and revisit our plan maybe later this afternoon.

So, if you don\'t have that document in front of you I think there are
extra copies on the side table. No? Okay. So we\'re going to put them on
the side table and maybe you can put it at one end, Michael. And we\'ll
start at the back of the issues. I think there are 18 and that is a
document that you received initially. I don\'t think they\'re more or
less from the other document. I could be wrong. But, anyway, we\'ll
start at the back and work our way through, get a sense of that. Does
that make sense to everybody? Hold on before we disband. Michael wants
to say a few more things.

(Discussion off the record)

(Whereupon, a luncheon recess was taken at 11:52 a.m.

[A F T E R N O O N S E S S I O N]{.underline} 1:32 p.m.

DR. LAYTON: Can we get started, please.

MS. SULTON: All right. All right. I need to remind to us of what I think
we came to agreement on before the break is that we\'re taking the list
of issues starting with the last issue working backwards and our goal is
to ensure that we have a clear and understandable statement of the
topic.

At the end of the day we will have a list of well-stated topics to
present to the Secretary in as part of the body of the report. As far as
process is concerned, what I would suggest is that we spend no more than
15 minutes on a topic to ensure that we believe it\'s clearly stated.

So, if we could start then with the last topic, the public interest with
regard to food \-- a broader than can be addressed by a science-based
regulatory system.

Greg, is it process?

MR. JAFFE: Process.

MS. SULTON: Okay.

MR. JAFFE: Questions. I guess my question is, we\'re trying to draft
language here that\'s going to be in a report? I mean, are we trying \--
are we just trying to capture what the issue is?

MS. SULTON: We\'re trying to capture what the issue is.

MR. JAFFE: Okay.

MS. SULTON: And we can wordsmith it further.

MR. JAFFE: So, format doesn\'t \-- we don\'t \--

MS. SULTON: It\'s the content of the statement. Is the text clear; does
it clearly state what we want to say there, not that it cannot be
wordsmithed further later, but, does it capture conceptually what we
want to say about that issue for that topic.

MR. JAFFE: Okay.

MS. SULTON: Any other process questions? I invite comments on that first
issue which is, in fact, the last issue on the list. A few minutes.

DR. VAN EENENNAAM: Is this specifically related to G food or old food?

MS. SULTON: Alison, your question is it is specifically to what kind of
food?

DR. VAN EENENNAAM: Well, genetically which I assume is what the issues
we\'re trying to address are.

MS. SULTON: Yes. I would think so, yes. We\'re talking about genetically
engineered food. Well, we don\'t use that term, do we? Is it genetically
modified?

DR. SCHECHTMAN: It is genetically engineered.

MS. SULTON: It\'s genetically engineered is correct. All right. Right.
So, yes, genetically engineered food. All right. Yes, Dick?

DR. CROWDER: I don\'t think we ought to move so quickly. I\'m not sure I
understand what the intent of the statement is to get back to your
point. There are the issue of if you put GE in there it begs the
question of what the science-based regulatory system is applying to and
I\'m not so sure that I can either agree or disagree with the statement
when we talk about public interest because I don\'t know exactly what
we\'re talking in terms of public interest as it relates to food.

MS. SULTON: Okay. Putting a place hold on that in hopes that maybe Greg
or others might answer it in their question. You had your card up first.

MR. JAFFE: Naturally, I\'m going to agree with Dick. I mean, I think
that \-- I mean, I\'m not sure I understand the statement. I mean, I\'m
not sure what the issue is because I think a science-based regulatory
system is related to safety so are we talking about food safety here,
are we talking about environmental safety?

So, I\'m not sure exactly what we\'re referring to when we say
science-based regulatory system, especially in the context of the public
interest. I think if you\'re going to have a discussion you\'re going to
have some language about this issue I think you need to qualify it with
how is it related to genetically engineered foods, as Alison said, but,
I also think you have to have some discussion about what are the public
interests we\'re talking about here and what are we talking about when
we say science-based regulatory system.

What are we referring to?

MS. SULTON: Okay.

MR. JAFFE: I think all of those things need to be qualified. I\'m not
going to answer what I think they should be, but, I \--

MS. SULTON: That\'s the question. Okay.

MR. JAFFE: But, I think they all need to be included.

MS. SULTON: All right. Carol?

MS. FOREMAN: Yeah. Let me \-- you know, some of these things grew out of
a lot of stuff that was thrown up on white pieces of paper at one of the
meetings. I think it would probably be more appropriate to have it say
the public\'s concerns about genetically modified foods are broader than
those addressed by a science-based regulatory system.

Food safety regulation as it\'s practiced today applies \-- uses
microbiology, toxicology, chemistry with regard to nutrition, but, many
people think about food in terms of purity and wholesomeness and these
are not issues that are addressed by a science-based system. That\'s why
you have a lot of people who want organic, for example, or free-range,
whatever it is that that means.

There are people concerned about the moral and ethical issues, concerned
with transgenic animals and cloning animals, so, it was an attempt to
address the notion that while a science-based system is what we have
and, goodness knows, I don\'t have an alternative to it, it clearly does
not respond to a substantial portion of the population that is concerned
about other things.

MS. SULTON: So, what you\'re saying, Carol, if I\'m hearing you
correctly is that it goes beyond food safety?

MS. FOREMAN: Yeah, it goes, I guess, to how people feel about their
food. It has not been much of an issue with plant products, but, it has
been for some people, but, it\'s a pretty substantial issue with regard
to animal products.

MS. SULTON: Mardi?

DR. MELLON: I made this point earlier and I\'ll make it again, I mean,
not today, in our discussions, and that is I\'m very uncomfortable with
the use of the word, science-based. I know that the U.S. Government does
it all the time. But, in fact, these concerns are not science versus
non-science. They are risks, either health or environmental risks versus
other kinds of concerns, all the way from humane concerns to how you
feel about your food, socio-economic concerns, moral and ethical
concerns.

I mean, there are a set of concerns that are not captured in the notion
of risk and it is those concerns that folks, you know, either don\'t
want addressed by regulatory systems, or, are quite clearly excluded
from the purview of the concern that a regulatory agency can take into
account.

So, I suggest that we don\'t use the word, risk \-- I mean, don\'t use
the word, science-based systems, or, we talk about risk-based systems
and, but, I do think, just as Carol said, it is a fact that the
regulatory systems in place, which are more or less confined to looking
at health and/or safety risks, do not address and are not a place to
address a lot of the concerns that folks have about genetically
engineered animals, but, I would also say about conventionally raised
animals.

I think there are a host of concerns that are emerging that will
increase the importance in the future that also find a hard \-- don\'t
have a home. So, I like \-- I think this is an important issue to \--
topic \-- an important topic to highlight because I think that it
actually does capture some of the problems that we\'re all going to
encounter as we try to use this narrowly based regulatory system to deal
with a technology that raises a host of non-risk based concern.

MS. SULTON: Is there a term that encompasses these types of concern? Is
there a term that we could use there?

DR. MELLON: Humane, social, economic, ethical. As Dr. Crawford put it,
yuck.

MS. SULTON: I\'m sorry, Alison.

DR. VAN EENENNAAM: I guess would a way to phrase it be the public
concern with regard to GE food or the public concerns are broader than
those associated with food safety and environmental risks?

MS. SULTON: Any response? Any reaction to that? Carol, does that
encompass what you were saying? Mardi?

DR. MELLON: I prefer it the way it is because, I mean, the problem
isn\'t just that there\'s a broad range of concerns. It\'s that the
systems, there\'s a mishmash between systems available to think about
approvals of products and the concerns that people have about those
products. I mean, I\'d be happy to restrict it to animals, I think.

I mean, I think, you know, not that there aren\'t some ethical concerns
about plants, but, I think that they all are social and economic, but, I
think that they are of a much lower level of intensity than will be the
set of concerns about animals.

MS. SULTON: Leon?

MR. CORZINE: I guess just for clarification or comment, I agree with
most of what Margaret said as far as there are those other concerns,
but, as I read this, that\'s what this says. But, I think everything
that USDA does and the government does we talk about science-based.

So, I would not be in favor of removing that term, science-based, and
this says there are broader \-- there are some issues broader than
science-based, so, that\'s kind of what you\'re saying?

DR. MELLON: No, but, they\'re not \-- I mean, let me give you an
example. A lot of people don\'t want genes from animals in their food.
They don\'t want genes from, say, from a fish in a tomato. Now, that is
not a risk-based concern. They don\'t believe that it threatens their
health. They don\'t believe it\'s an environmental concern. They simply
don\'t want that.

Now, that is an issue that needs to be addressed in the context of
science. It is only science that can tell us where the genes come from
and could help articulate the ways in which that would make a
difference.

If you have a system that would address that concern, which is, I would
say, an ethical concern for a lot of folks, it would have to be
addressed by a science-based system. What makes those concerns different
isn\'t that they are not based in science or you don\'t need science to
address them, it\'s just of their nature. They are \-- these are moral
or ethical concerns rather than risk concerns.

So, I think we would do the world a big service to move away from
talking about science-based concerns. That is way too broad a use of the
word and it doesn\'t accurately convey what people are, I think, trying
to say. So, I would really prefer that we not use that.

MS. FOREMAN: Your suggestion then would be that it be something like the
public concern with regard to genetically engineered food is broader
than can be addressed by a risk-based system, regulatory system? Is that
what \--

MS. SULTON: Pat, did you want to make a comment?

DR. LAYTON: No.

DR. MELLON: Public concerns with regard to food animals are broader than
can be addressed by a risk-based regulatory system or animal foods maybe
would be the better.

DR. DYKES: I guess just a \-- I understand what you\'re saying, Mardi,
that there are concerns that people have about foods and the example of
fish in some products or something, but, that they could be handled by
science. If we say that they are concerns that can\'t be addressed by a
risk-based system, but, yet they could be handled by science \--
there\'s a concern that can\'t be addressed by a risk-based system then
how do we address them?

I guess \-- I mean, I\'m just wondering what your thinking is about how
you use science to address the fact that people don\'t want them and I
agree with you, there are people that for a multitude of reasons want
things that are any number of examples, but, help me think through how
you do it if it was not risk-based, but, yet, it\'s science-based.

DR. MELLON: There are a number of concerns that are science-based. I
mean, it is a scientific question whether the genetic material you\'ve
got in your tomato came from a \-- you know \-- came from an animal and
it is further a scientific question, you know, whether it is a gene or a
set of genes that conveys fishness or whether not, whether they are just
such small snippets of DNA that they don\'t matter.

I mean, those are scientific questions that you would have to address if
you seriously wanted to take into account someone\'s morally or
ethically based concern about not taking in animal food, you know, in a
plant food.

And I don\'t want to get into those issues, but, I\'m just saying it\'s
not accurate to say that they\'re not science-based. There is a
scientific basis to them, both in terms of how they\'re articulated and
how they would be responded to. So, I just think it\'s \-- what we\'re
talking about is health and environmental risks.

I mean, and it is systems that address those and that\'s the set of
concerns that, you know, is treated differently and more explicitly in
most regulatory systems.

MS. SULTON: Greg?

MR. JAFFE: Yeah, I guess I wanted to say a couple of things. One is, I
mean, I agree with Mardi about the \-- I mean, the problem I have with
the science-based regulatory systems is that there\'s a lot of interests
that aren\'t science-based. Regulate organic foods, the use of the word
organic, it\'s not a science-based regulatory thing. It\'s based on
misleading, it\'s based on a whole set of criteria, but, it\'s a
regulatory system.

Clearly, government regulates how you can use the term organic. We have
all kinds of labeling of foods that are all based and are not
necessarily based on science. So, I mean, I think \-- so, I\'m not sure
when you say science-based regulatory systems what we\'re referring to
because we have regulatory systems that are some more science-based than
others.

So, I think we do need to clarify if we\'re going to discuss this
whether we\'re talking about, you know, a regulatory system that
addresses food safety or addresses environmental risks or whatever it
addresses that we\'re talking about here. The biotech products don\'t go
\-- don\'t tend to go through those kind of systems, so, I think we need
to specify. That\'s the first thing.

So, I do think it\'s a little weird to say science-based regulatory
system because it sounds like you\'re talking generically about
regulatory systems and not all regulatory systems are science-based. And
I\'m not sure how we would start defining which ones are and which ones
aren\'t.

The second one is, I think if we\'re going to discuss the public\'s
concerns, and I think Mardi mentioned something, Carol mentioned
something about that, I think you have to have, maybe not on the first
sentence, but, you do have to have some discussion of what those
concerns are, some examples or something like that just to have a single
statement about it. I think more people will understand. Those who
haven\'t heard the discussion won\'t have the context for that.

The third one is, I mean, I think I go the opposite way than Mardi did.
She was making GE foods narrower, just animals. I actually think I\'m
not sure we should limit it to food, but, genetically engineered
products. I mean, I think of pharmaceutical crops where a lot of these
concerns that I\'ve heard, economic concerns, the concerns Mardi talked
about, about Anheuser Busch and the people in Missouri, the farmers in
Missouri who were rice farmers, their concerns were that this might \--
that this pharmaceutical crop might get in and it would hurt their trade
and that was an economic.

I include \-- we\'re talking about public concerns I assume they
included economic things and I assume they included farmers\' concerns.
The public is a very broad term here, so, if anything, I would want to
go the other way and call it genetically engineered products and not
limit it just to food because I think that some of these same concerns,
human, social, ethical, economic exist not just for the animals and not
just for the plants, but, for the range of genetically engineered
products out there.

MS. SULTON: If I can try to summarize what I think I\'ve heard us say
here is that we are talking about genetically engineered products or
food, that\'s the point in discussion, and possibly striking
science-based and just talking about regulatory systems. So, \--

DR. MELLON: Risk-based.

MS. SULTON: Risk-based instead of that. And then to have some examples
that clarifies or elucidates a little bit about what we mean by public
concerns to include the environmental, ethical, and yuck.

DR. MELLON: I think that is a term in the philosophical literature.
It\'s not \-- I did not make it up.

DR. VAN EENENNAAM: If we\'re going to include all products do you want
to distinguish, you know, between \-- are you talking about agricultural
products or \--

MR. JAFFE: Yeah, yeah, limit that. I\'m not talking about \-- I wasn\'t
saying \-- suggesting that we talk about drugs that are produced from
microorganisms in vats in manufacturing plants. What I was trying to
sort of say that I think the role of this committee has always been
agricultural biotechnology, so things that are related to agricultural.

DR. CROWDER: Quick question. If the fish gene that Mardi put in the
tomato cured diabetes would it be included?

MS. FOREMAN: Let me \-- let me respond. Yeah, I think people \-- what
you\'re saying here is not that it should be excluded. You\'re saying
that the concerns that people have are not always addressed by this
statement that we have a science-based system because some of those
issues aren\'t. And, of course, you know, if you\'re going to get into
the fish gene that might cure diabetes then you\'d run into a whole
bunch of regulatory questions about how do you make sure it only ends up
in that tomato.

MS. SULTON: Getting back to our, I think, commitment to just explain the
issue rather than solve the problems that might be raised with it, it
appears to me \-- and please correct me, as I\'m sure you will, if I\'m
wrong \-- that the public\'s interest with regard to genetically
engineered agricultural products \-- I\'m sorry, the public concern?
Concerns with regard to genetically engineered agricultural products are
broader than can be addressed by a risk-based regulatory system.

Okay. Leon?

MR. CORZINE: The only thing, if you\'re going to say it that way I would
recommend we put "some" instead of "the" because it looks like a
statement that I wouldn\'t agree with, but, if there is some it makes a
heck of lot \-- it makes a difference.

MS. SULTON: Obviously it wouldn\'t be all so some makes sense. All
right. Dick, did you have another point?

DR. CROWDER: I just wondered where we are in the process. If we move
from this to the next issue is this considered sign off or agreement or
what because, okay \--

MS. SULTON: No, it\'s a place holder that we\'ve discussed it now
because it hadn\'t been discussed before. In the next document that
comes out it will be our \-- it will be based on our notes and you\'ll
get to review it again.

DR. CROWDER: How the issue is stated?

MS. SULTON: Right.

DR. CROWDER: Because I get concerned about \--

MS. SULTON: Well, we\'ll make \-- actually, at the end of this meeting
we\'ll set up a work plan on how we\'re going to proceed to expand or
wordsmith these things, make them into a report.

DR. CROWDER: Okay. Just let me summarize what I just heard and then you
can correct me if I\'ve misinterpreted. An issue similar to, as been
stated \-- a topic similar to what has been stated here will be included
for final review in terms of the statement of the topic before it goes
to press?

MS. SULTON: Yes.

DR. CROWDER: And this will be the case for all of these?

MS. SULTON: Yes.

DR. SCHECHTMAN: If I can just add one thing. One of the ways we talked
about this over lunch is that we are inventorying the issues, going
through, making sure that we all understand what they are. If we
actually should get a statement that everyone is very clearly
comfortable with that\'s great. If that doesn\'t happen we\'re going to
go back and check a number of times before anything is, you know,
considered to be checked off on.

This is not \-- none of this is irreversible at this point. But, we want
to \-- we\'re examining the state of play of each of the issues. And
we\'re trying to make sure that we go through all of them, get a rough
approximation of, "Is it clear, do we know what it\'s talking about?" Is
the statement, you know, on its face, is it something that all of a
sudden everyone on the committee says, that\'s great. If we do that,
that\'s fine. We\'ll still have a chance to go back and look at it
anyway, but, at the very least to get an approximation that this is part
of the inventory and process as we go along.

MS. SULTON: Greg?

MR. JAFFE: I mean, what I thought we were doing here was trying to find
out if everybody\'s clear on what the issue is, not whether the
statement states what the issue is because, again, like I said here,
you\'d want to have some discussion of what the public concerns are,
you\'d want to have some discussion of what is the risk-based, what the
regulatory system means.

So, \--

MS. SULTON: That\'s all \--

MR. JAFFE: \-- I\'m a little concerned here that we\'re \--

MS. SULTON: No, no.

MR. JAFFE: \-- not trying to \-- I thought we were trying to come up
here and have a discussion on topics and say everybody understands what
this topic is, not necessarily the language that describes that topic.
But, you\'re sort of saying, well, if everybody likes the statement then
we\'ve described the topic. I don\'t think we should go there for any of
them today because I think it starts getting us all confused whether
we\'re \-- I don\'t know whether I\'m doing this one or not doing that
in this one; whether I\'m committing myself in this one or not
committing myself in this one.

So, not even commitments. I\'m not even talking commitments. I don\'t
want to come back and say, well, we had this discussion and people
seemed comfortable with the word concerns or whatever. I thought our
goal here was to make it so everybody understood the topic and the topic
that we want to include.

MS. SULTON: We\'re going to have the Minutes from this discussion to
include all those points that you made about expanding the term or
giving examples and at the end of the day when we come up with our work
plan we\'ll figure out how we\'re going to begin to address the sum of
things that we will have gotten.

This is just an opportunity for the committee to talk about each and
every issue today for at least 15 minutes, which brings us to the next
issue. Thank you. The issue is currently stated. Mardi, you don\'t want
that, do you?

DR. MELLON: No, sorry.

MS. SULTON: Okay. The issue as currently stated, as presently stated is,
"The success of new, more visible agricultural biotechnology derived
food products will be influenced by whether food processors and
retailers embrace these products as adding value to their businesses.
Their decisions will, in turn, be influenced by whether the consuming
public perceives the resulting genetically engineered food product as
offering enhanced value such as improved safety, taste, appearance,
price, or, nutrition."

Is everyone clear? Does that clearly state an issue that we can all
understand? Josephine?

DR. HUNT: Just a question. What is meant by more visible agricultural
biotechnology?

MS. SULTON: Very good question. Carol?

MS. FOREMAN: One of the earlier texts on this referred specifically to
genetically engineered wheat that would be clearly distinguished. It was
trying to move away from the feed grains into products that are more
likely to be used immediately in a final product and to be quite
distinguishable in that product.

MS. SULTON: Carole Cramer?

DR. CRAMER: Am I missing something? Why is this an issue? It seems like
it\'s stating the obvious that, of course, the success of a product is
going to be based on whether it\'s embraced. As we\'ve talked to all of
our food manufacturers, the General Mills guys and stuff, they say we
don\'t bring something forward unless our consumers say they\'ll
purchase it in order to protect their brand.

MS. FOREMAN: I think that\'s specifically not true with regard to corn
and soybeans which were supply- push products, not demand products, and
that people accepted them, have been using them for years without
actually knowing they were in the food and in part because a great
portion of those products come to us after being passed through animals
as feed.

So, as the products move to meat, and bread, or, animal products that
are clearly the fish, the transgenic fish, fruits and vegetables, and
they are quite obviously visible as genetically engineered products I
think it is a question. I think it was one of the questions, as I
recall, that was referenced in the scenario document as to whether or
not these products would continue to grow; the breadth of products
offered would continue to grow.

MS. SULTON: Do you want to follow up?

DR. CRAMER: I don\'t disagree. I think that from the point of view of
there\'s a real need and opportunity to bring real consumer demand of
biotech products too, but, my question is, what\'s the actual issue
here? Because as it\'s stated I don\'t see that there is a discrete
issue. What\'s the concern?

MS. SULTON: Greg?

MR. JAFFE: I mean, I think the issue \-- I mean, I agree with what Carol
said and I think that the issue is is that the next generation of
products, be it genetically engineered wheat, be it transgenic animals,
be it enhanced soybeans, whatever it is in it, they\'re going to be more
influenced. In the past, that\'s right, the market \-- in the past it
was whether the farmer got some benefit from it and it went throughout
the rest of the chain. The rest of the chain didn\'t chime in in the
same way. They didn\'t know it was happening. Today though, the rest of
the chain is going to chime in and they have been chiming in as you saw
in engineered wheat and so forth.

So, I think that this is stating that for the next generation of
products, and we can define what those are, maybe not the words, more
visible and new, but, for the next generation of products I think what
this is saying is that food processors, retailers, and others are going
to play a much bigger role in whether those products get to market and
that decision will, in turn, be based on whether there\'s value to
others in the chain other than just the farmer.

So, I think it\'s raising \-- I think what it\'s sort of saying is that
new products coming to market in the future have a more complex group of
actors in the society that they\'ve got to show benefits for it or
people are going to at least have that \-- there\'s going to be more of
a discussion about those products.

MS. DILLEY: The issue that I remember is this is like I refer to, Ron,
as your pink car discussion.

MS. SULTON: Brad?

MR. SHURDUT: Yeah, I\'m a little bit where Carol is too. I mean, we\'re
just making a statement. There\'s no question whether it\'s a biotech
product, or, a new flavor, or, anything. Obviously with a biotech
product and it\'s new and it hasn\'t been like genetically engineered
wheat and some of those that haven\'t been on the market or as we get
into animals or something that will create more, I guess, involvement in
the decision making process by food manufacturers whether to roll this
out or not.

But, it\'s not any \-- it\'s not an issue to me. It\'s just a fact.
We\'re going to do that. And the industry\'s going to do it. So, I
don\'t know whether we plan \-- maybe we get rid of the word issue and
just say that\'s just a statement or a topic because it\'s not an issue
whether we\'re going to do it or not. We are going to do it.

MR. JAFFE: Then the issue becomes the first two words of the thing. The
success of those products is now going to be tied. That\'s right,
that\'s right, the food industry and other people are going to have a
discussion about whether to embrace this, whether to market this,
whether they want to sell products that have genetically engineered
wheat in them or not or they want their bread to include that or not
include that.

You\'re right. You guys are going to make logical, whatever, kind of
decisions. What I think this issue is getting to is, and what\'s
interesting for the Secretary of Agriculture, who, you know, we had the
Deputy here talking about how they\'re pro biotech and so forth, is that
now the success of biotech products, the next generation of products, is
going to be in part related to that discussion.

So, that is the issue is that there\'s now this \-- the discussion that
went on for around everybody\'s soybeans or around everybody\'s corn was
different and now the discussion that will go around in terms of the
success of these next generation of products is going to have different
actors involved.

I don\'t think it\'s a statement that what food processors are doing is
negative or anything like that. It is logical what you\'re going to do.
I think what this is saying is that now the success of biotech is going
to be more tied to that than it has been in the past.

MS. SULTON: Brad?

MR. SHURDUT: I guess just my point here is one I agree the fact that
this seems to be more of a fact than an issue, but, how is this any
different, if you took the last issue we looked at and brought in the
public to stakeholders in general, how is this not tied into and rolled
into that same issue? Why are we differentiating the two? It seems to me
it\'s just restating it.

I mean, you just want to elaborate it, elaborate on it more, but, it\'s
really the same as the last issue.

MS. SULTON: An example perhaps of what Daryl was talking about earlier
that we would have that opportunity.

MR. SHURDUT: So why don\'t we just cut it and brought in the other one
and maybe the public or stakeholder?

MS. SULTON: I think for process we wanted to keep them here now so we
could make sure we state it clearly what we meant by them and then if we
saw that we could combine or categorize them that would be another
discussion.

Mardi?

DR. MELLON: I do think we ought to call it topics. I think they\'re not
issues in the sense that one usually thinks of an issue and certainly, I
mean, this is, you know, this is a statement that I think we\'d all
agree with, but, I think it is a topic that is important for us to raise
to the Secretary because it, in fact, links the efforts and the goal of
the USDA which is to push biotech. What happens over at FDA, for
example? It makes it harder for the Secretary to not want to know what
is going on over at FDA because this links the success of the USDA\'s
efforts with the success of products in the consumer arena dominated by
other agencies.

MS. SULTON: Carol?

MS. FOREMAN: Yeah. Actually, there is another issue raised by these. If
you were to go back and look at the original text for both of these
issues you\'d see that they were stated much more pungently. In order to
try to make them more acceptable in every single statement in this
chapter the sharp edges have been taken off.

And, so, you get a question like so what\'s the issue here, I can sure
state this one as an issue, the effort was being made to state it in a
way that was extremely even-handed and, so, I think topics, concerns,
factors that the Secretary will have to deal with probably addresses all
of these more appropriately.

But, as they were thrown up on the board and as we tried to address them
initially they were all a lot sharper than they are now.

MS. SULTON: Okay. Michael?

DR. DYKES: I just want to comment on the comment about soybeans and
corn. I think this thing is true, not just about new products, but,
continuing to keep products on the market as well. You\'ve got to make a
decision about when you\'re going to take things off the market. And
there have been other new products introduced in corn and soybeans. I
think there have been four or five new, six, seven, eight new corn
products introduced. There have been new cotton products introduced.

So, I don\'t think corn and beans have been introduced with any kind of
discussion with the food processors.

MS. FOREMAN: How about with the public?

DR. DYKES: I would say there\'s a lot of discussion with the public
about corn and beans, Carol. I mean, that\'s always been the \--

MS. FOREMAN: Only after the fact.

DR. DYKES: We\'ll have to agree to disagree, but, there\'s a lot of
discussion about \-- I could think about companies around the table we
had discussions with about these products.

MS. FOREMAN: Let me \-- let me rephrase then just a little bit. Once
again, nobody marketed genetically engineered corn or soybeans because
there was a great consumer demand, retail consumer demand for them. They
were created because they provided a benefit to the agricultural
producer the way that Chuck stated it this morning.

It probably didn\'t make much difference to the consumer because these
products weren\'t very visible. It made a hell of a difference when the
corn \-- gosh, I can\'t remember it now \-- the StarLink® corn that
wasn\'t supposed to be food got into Fritos and everybody was apoplectic
so it clearly did create a public concern.

When you have these products being visible every day then the
producer\'s desire for a more effective raw product will get balanced
against the consumer\'s willingness to accept something that they\'re
not entirely comfortable with.

MS. SULTON: All right. Dick, did you have your card up?

DR. CROWDER: Yeah. Carol, not to disagree, but, I want to make a point I
made earlier a year ago, two years ago, whatever it was. I get a little
concerned about our discussion of things that benefit the farmer but
don\'t benefit the consumer and I appreciate very much and regret very
much the StarLink® corn and that\'s something that goes with this, but,
let\'s put that aside and talk about things that benefit the farmer that
were designed to benefit the farmer, not to benefit the consumer.

Hybrid corn was designed to benefit the farmer. Over the years hybrid
corn has benefitted the consumer extensively. The development of no-till
ability in terms of agronomic practices in soybeans were designed to
benefit the farmer and the environment, but, the consumer has benefitted
from those. The increase in the production of milk per cow was designed
to benefit the farmer, but, the consumer has benefitted more.

So, I don\'t think that we should condemn something or say it won\'t be
accepted because it was designed to benefit the farmer and not the
consumer because consumers here and a lot of places have benefitted from
productivity on that side. I don\'t think that\'s what you\'re saying,
but, I just wanted the record to at least say that benefitting the
farmer is not \-- is independent of benefitting the consumer.

MS. SULTON: Think we\'ve had some rich discussion of this next
generation or more visible agricultural biotechnology derived foods and
the implications thereof, so, if we could move to the next issue if
that\'s okay.

Michael?

DR. SCHECHTMAN: Yeah. I just wanted to add one other clarification and
this is, again, I think for the benefit of the new members on the
committee that in one way earlier version of the efforts of this
committee products were categorized into three different categories, the
names of which I think at the last iteration were productivity
enhancements, quality enhancements, and specialty products.

My impression of this issue was at one point it was leaning a bit more
towards some of the newer ones which were in the second and third
categories, but, I think that Carol also brought up that some of the
products that may be in the first category, that that will be more
directly used by consumers might also fit in that.

But, I just wanted to add that little bit of history from how we were
talking about the product and the work that was going on.

MS. SULTON: Leon?

MR. CORZINE: Cindy, I, just for statement of fact, I guess, and probably
didn\'t have \-- I don\'t have producer when you\'re talking about when
you\'re categorizing things, but, going along with what Dick said, you
know, we look at things, production enhancement, but, that first corn
product with BT corn was also quality enhancement because we didn\'t
have \-- we had a more uniform product. We didn\'t have the insect
damage and all of those kinds of things and the toxins that go with some
of the storage problems.

So, it was a consumer benefit at the end of the day, my consumers and
processor. Now, at the end of the day that is me as a consumer that eats
whatever we produce from that and I guess I am still in the camp that,
okay, this is a statement of fact. We\'ve got the next one. I guess
it\'s okay to leave it, but, I\'m confused as to why it\'s even needed
to be here as Carole said, and this Carol said, in the first place and
Brad did.

This is true with any product that I choose to use on my farm anywhere.
It doesn\'t matter if it\'s biotech or not. If there isn\'t consumer
acceptance we\'ll have influence on whether this product is used or not.
If I want to grow pink corn it\'s going to be whether there\'s a market
and the consumer acceptance or a demand for it.

To me, this doesn\'t even \-- this is just adding some words to the
document that don\'t do anything.

MS. SULTON: You know, as a non-agricultural person, when I read it I
read it to mean to infer that there was going to be increased public
perception that biotechnology engineered food was out there more so than
it had been in the past; that it was getting to kind of the growing
knowledge of the public and inferring that there was a certain degree of
ignorance at one point in time and that\'s what I thought it was saying.
Carol?

MS. FOREMAN: Yeah. Let me \-- we\'re now into it. This morning Chuck
talked about we\'re all here because we care about agricultural
production. You know what, it\'s not my first concern. I\'m on the
committee to represent all those other people. There is a public concern
about biotechnology, about genetic modified foods. You would
characterize much of that as being irrational.

I\'m suggesting that whether it\'s rational or not, it\'s real and if
people don\'t like it they will not want to buy it. The products that
are on the market now have not confronted this so much because they
weren\'t very visible and got out there into all these products before
anybody was really aware of biotechnology.

And, if you had to market them today after the EU battles they might
not, in fact, succeed. There\'s a reason why the wheat\'s not out there
now and it has to do with the concern about public acceptance of wheat
products. So, it is true that hybrid corn and other things have come
along over the years, changed our food supply very substantially, the
basic products of the food supply. This is the first thing that has come
along since we have had instantaneous communication so that every
mistake and every concern is circulated around the world very quickly.

So, you have a problem that you didn\'t have to address before and,
again, the initial products were not put out there because I wanted them
in my Fritos and my corn oil. It benefitted the original producer.
Sometimes our interests are not exactly the same. Frequently they are,
but, sometimes they\'re not and the public perception that genetically
engineered food is less than desirable is clearly a concern that food
processors and food retailers have about \-- that they have.

If they didn\'t have it all these products would probably be labeled.

MS. SULTON: We\'re coming to the end of this discussion. Greg, Bob, Abby
and Carole.

MR. JAFFE: I just wanted to comment that I don\'t think these first two
topics we\'ve been discussing are the same at all. I mean, I think that
the first one we discussed really deals with regulatory system and says
that there are concerns outside of the risk-based regulatory system and
says people have those. It hasn\'t talked about whether people accept
the products or doesn\'t accept the products or what causes them to
accept it.

It just talks about the fact that when one talks about agricultural
biotechnology there are a host of concerns that are raised. Some of them
are food and environmental safety concerns, but, others of them are
social, or, economic, or, ethical, or, religious, or, other ones and
we\'re just pointing out that those aren\'t covered by the regulatory
system and that\'s something that the Secretary should be aware of
because just saying a product made it through and got an approval does
not automatically mean that people will accept it.

The second issue is different. It\'s sort of saying \-- I think it\'s
getting to \-- I mean, I\'ve been involved with this issue for five
years now and I\'ve been to numerous, thousands of conferences and
discussions and articles and constantly the issue is brought up of, you
know, who benefits. Who\'s the beneficial person for that particular
product and one of the things that people say is why the products
haven\'t been accepted in Europe is that the consumer doesn\'t benefit.

I don\'t dispute with you, Dick, at all. I do think that, and I\'ve
advocated that the fact that farmers benefit and other people down the
chain benefit, that\'s beneficial to consumers also at some level. But,
I think that I\'ve always thought of that as more an indirect benefit
than a direct benefit.

But, I do think that the second issue is getting to how people are going
to accept these next generation of products which are being \-- and
that\'s how I would describe some of these \-- they\'re going to be more
directly related to the consumer. And, so, I don\'t think these issues
are the same as the topics. I don\'t think these topics are the same.

I think there are two topics that any time you see articles in the media
about agricultural biotechnology, any time you go to conferences about
them, these are two \-- and the discussions between the U.S. and EU,
these are very big topics so I think to not include them would be
missing something.

MS. SULTON: Bob?

DR. HERDT: Basically I agree with the last two comments. I think that
this report is a report to the Secretary of Agriculture. It seems to me
it\'s saying that this committee is advising him that consumer concerns
are going to be more important in the future than they were in the past.
I think we ought to say that.

MS. SULTON: Carole?

DR. CRAMER: As we talk through and I look at this I\'m remembering some
of the history of coming up with this issue and I think that this is one
of the situations where we merged several issues and one of the issues
was the concept that we need value-driven or consumer benefit products.

But, the other was the issue that perceived acceptance and major
retailers are driving much of what goes on. And I\'d just like to throw,
especially to the new committee members, one of the earlier discussions
in the first year we had a number of experts come in and one of the
things that I was struck and discouraged by was I think we had maybe
somebody from DuPont come in and talk about high density potatoes that
actually could have resulted in a significant reduction in the oil that
would be in French fries and potato chips.

But, in fact, because of issues of acceptance by, I believe it was
McDonald\'s, this was scrapped from the country \-- the company and
their products. So, the idea is that it\'s not clear necessarily that
consumer value will protect a product going forward. If it were up to me
and anybody asked I would be delighted if this product were currently on
the market.

And, but, it doesn\'t appear to be that just value and acceptance by
consumers as enhancing that product\'s safety, or, health, or, taste is
sufficient to address the issues that we\'re getting to. So, that was a
long-winded answer to say maybe part of the reason that I find this
statement bothersome is that actually there\'s multiple issues in here
and I\'m going to have to admit to being a splitter instead of a lumper
here because I can\'t stomach the lump.

MS. DILLEY: Just say hi, my name is Carole and I\'m a splitter.

MS. SULTON: Abby, you had more to say, right?

MS. DILLEY: I just think that maybe it\'s just the fact that of what
Carole said that there are a couple of different things in here. I
thought the bottom line on this one was that the conversation around the
next generation of products has become a more complex conversation. We
didn\'t used to talk about what Wal-Mart or McDonald\'s might do in the
first generation of products and this is just getting to be a more
complex conversation and it was a recognition of that.

MS. FOREMAN: Can I just quickly respond there? You know, McDonald\'s
would have used it if McDonald\'s thought it would sell more hamburgers
so in the end, in fact, it was that they were not willing to adopt a
more visible product because they knew that their competitors might say,
oh, yeah, look at what they\'re using, GM potatoes. So, in the end it
was, I think, the same issue that there was a concern that the retail
consumer would be reluctant to purchase this quite visible product.

It\'s a worry to me because I would love to see biotechnology used to
produce fruits and vegetables that can retain their freshness longer, a
whole range of products that would have more nutritional benefit. It\'s
having the retail consumer know those products were made with
agricultural biotechnology prevents people from producing them and using
them it lost something.

It lost the chance to sell it. So, until there\'s a perceived consumer
benefit I think there\'s a real problem out there.

MS. SULTON: Dick?

DR. CROWDER: One statement and that is that we are all in our
discussions implying that this new, more visible set of products will be
of the same id and nature that the past have; that there won\'t be any
health benefits; that they\'re won\'t be any Omega-3 oil that may be
useful. We\'re making some assumptions here that I\'m not so sure are
correct or may not be correct.

And I think as we think forward the statement that Bob made a minute
ago, without getting into all the details, and I would change one word
in it, and Bob said, consumer concerns will be more important in the
future than in the past. I think the word I would probably change in
that is consumer awareness because the concerns could be positive \--
the word, concerns, could be positive or negative. Consumer awareness
will be more important in the future than in the past, period.

And we all know what consumer awareness means. Just a thought.

MS. FOREMAN: Let me \-- Dick, listen, this sentence says their decisions
will be influenced by whether products offer enhanced value such as
improved safety, taste, appearance, price, or, nutrition. I think
that\'s what you just said. It assumes that if you\'ve got a product
that offers some of these values it may be successful.

DR. CROWDER: Thank you for the statement. If that\'s what I just said
then if we were going to go to the objective of shortening of what Bob
said and change the one sentence was one sentence versus a paragraph.

MS. FOREMAN: And I want to tell you that I think it\'s important to
spell it out just a little bit. You\'ve got a 50 page or so labeling and
traceability product which I thought sometimes went maybe into a little
too much detail, so, you know, let\'s have a little \-- a few words. You
know, we can take a paragraph on consumer concerns.

MS. SULTON: I guess we were also talking about the impact on the whole
chain. There are a lot of places where the decision is going to be made,
as everybody inferred, whether it would be at the retail, or, at the
processor, or, at the absolutely end consumer. But, it\'s obviously an
issue because we\'ve talked over 15 minutes about it.

If I could, it\'s obviously an interesting and changing topic.

DR. DYKES: I don\'t know that the fact that we talk about something for
15 minutes necessarily automatically directly means that it\'s an issue.
I\'d question that.

MS. SULTON: I stand corrected on it. I\'m sorry.

DR. DYKES: I\'d question that assumption.

MS. SULTON: Yes. That was a flip remark. I will withdraw it.

DR. DYKES: Thank you.

MS. SULTON: And I was trying to use it as a segue but it was very
clumsily done.

DR. DYKES: A lot of times you end up talking about topics for a lot more
than 15 minutes and I\'m never convinced that they\'re very important.
Not just this committee, but, in general.

MS. SULTON: I understand completely, truly. If we could though go to the
issue that deals with information and it is this topic reads, "In the
next five to ten years consumers will continue to want information about
foods derived from agricultural technology and there will be a need to
ensure accuracy of the information." Margaret Mellon?

DR. MELLON: Well, just for the sake of all the folks who were not with
us that is the labeling statement with its little edges roughed off. In
case you couldn\'t hear that, Dr. Layton.

DR. LAYTON: Thank you, Mardi.

MS. SULTON: So, does that mean everybody understands this statement?

DR. MELLON: I think we do.

MS. SULTON: Is there any need to discuss it? Any comments on it? All
right. We\'ll elaborate in the future on that.

The topic just prior to that one states \-- okay, Michael wants \--

DR. SCHECHTMAN: Just to make sure that there\'s no one else who wants to
say anything after the laughter dies down.

MS. SULTON: Okay. The topic before that reads, the FDA system for
regulation of foods \-- I\'m missing a page. Sorry about that. We were
really progressing under my system. The topic reads, "The emergence of
transgenic trait sensitive markets has introduced a new level of
commercial risk with liability insurance implications for all
participants in the food feed chain."

Oh, Ron.

MR. OLSON: It\'s not just liability insurance, it\'s liability
implications. There\'s an insurance issue that elevators can\'t get
insurance on some farms, but, there\'s a liability implication that\'s
not covered by insurance that\'s out there as well.

MS. SULTON: Okay. So, we\'re deleting insurance, not because it\'s not
applicable, but, it\'s not the entire thing, is that right?

MR. OLSON: That\'s right. Yeah, \--

MS. SULTON: It\'s one category.

MR. OLSON: Yeah, if you go back to what Chuck said this morning, this is
really an issue on export grain more so than the domestic. Insurance
problem, it\'s a domestic issue, but, it\'s really not an issue in the
marketplace, the domestic market. So, it\'s really an insurance \--
it\'s an issue of how do you handle cargos that arrive on the other end
that tested okay on this end and tested maybe on the other end and who
pays for that, where does the liability go.

I think the tracing labeling report covered this in relatively good
detail.

MS. SULTON: Okay. Michael and then Daryl and then Greg.

DR. DYKES: Ron addressed some of my comments there at the end. I guess I
just raised a question about is it for all \-- do we want the word all
participants on there? I\'m not sure all is applicable.

MS. SULTON: Many. Some. Participants. Shaving words. Daryl?

DR. BUSS: My memory may be faulty, but, I was recalling this as having
started with the specific discussion about insurance and I was wondering
if we really want to drop insurance entirely or broaden it to say level
of commercial risk of liability implications, including insurance
coverage, so, we didn\'t lose that element of it. I mean, we\'re not
really at the point of wordsmithing, but, I hate to drop it out entirely
if that was one of the original drivers that I thought led to that
statement.

In the notes that I just took down from what Ron had said I thought when
we expanded we were going to deal with both the export issue and the
domestic insurance issue, but, I thought I heard him say so when we
wordsmith it we would make sure that we covered both.

Greg?

MR. JAFFE: I guess I had a question maybe to Ron. But, just generally, I
mean, I think I understand this issue, but, I also assume that
transgenic markets are also organic markets and people domestically who
would be, you know, eating General Mills or other types of organic lines
and things like that isn\'t \-- I mean, are those included here? Should
those be discussed?

And there is an issue of, when you\'re talking about transgenic
trait-sensitive markets, organic are a transgenic-trade-sensitive
market. I mean, it\'s \--

MR. OLSON: The only thing organic, the rules are defined, it\'s a paper
trail. There\'s no testing for organic. You can\'t test for it.

MR. JAFFE: But, I mean, I hear about all these \-- there are lots of
commercial risks with organic and the interaction of the coexistence of
organic and transgenic and the markets, therefore, the markets that
they\'re going to, I mean, there is a lot of commercial risk from
different participants in that market.

MR. OLSON: Yeah. I guess I didn\'t \-- I would treat that as a separate
issue totally. I mean, we could maybe incorporate it. Even the fact that
you\'re exporting organic and somebody tests it and it tests transgenic
may say it\'s not organic. Is that what you\'re referring to?

DR. MELLON: Yes. So that \--

MR. OLSON: That was the question. I just wanted to clarify.

DR. CROWDER: But, that\'s not how you determine what organic is by
testing.

MR. JAFFE: What about the commercial? We\'re not talking about legal
issues here. I\'m not talking regulatory issues. It\'s not a regulatory
issue. I\'m not \-- I mean, the difference between the regulatory \-- I
mean, organic is \-- that\'s right, there is a regulatory program for
organic and organic, if you follow the paper trail you can call it
organic. What I\'m saying is there\'s a lot of commercial risk involved
with organic markets these days because of people do require testing or
they have other commercial obligations and there\'s a whole new level of
risk, commercial risk, and this was the major issue here, I thought was
the level of commercial risk because of transgenic-trait-sensitive
markets.

Organic is a trait-sensitive market that has commercial risk. That\'s
why I was asking about it. Whether it\'s put in a different issue, I
have no problem with that, but, I just wanted some clarification. I
think it is the same kind of risk issues different than a regulatory
issue.

MS. SULTON: Dick and then Leon.

DR. BUSS: Just to follow up to Greg\'s point on the organic liability.
The commercial risk in terms of organic, in terms of liability, occurs
only if you voluntarily enter into a contract to deliver organic food in
which you have assured that it\'s 100 percent trait-free.

It\'s something that you enter into in terms of a commercial contract.
Other than just a normal organic process, the commercial risk is not
increased unless you violate the process of producing organic.

DR. MELLON: No, but, really there are now countries, South Korea is one,
that will not buy. I mean, they\'re not entering into contracts.
They\'re simply telling the organic folks here that if there\'s any
detectable GE in it they\'re not buying it as organic and, again, not
legal, purely commercial, and proceeding not as a result of a contract.

MS. SULTON: Leon and then Greg again.

MR. CORZINE: Yes. I was going to \-- Dick said a lot of what I was going
to, but, it is still, and I understand, Margaret, as far as with South
Korea that is a contractual arrangement if you want to sell anything to
that country, but, the organic folks and a lot of other niche markets, I
mean, there are commercial risks even before the days of transgenic
crops.

I mean, there are risk as far as if chemical residue shows up, you know,
and if \-- so there are a lot of things that I don\'t know if you need
any separate deal. It\'s not organic specifically. It\'s not \-- it is
not trait sensitive necessarily, what the risks are, commercial risks
are, for the organic grower.

The folks in my area that grow organic, their biggest commercial risk is
whether they have so much foreign material whether they can store the
product and they have a lot of storage costs and then whether they can
find a market.

So, see, those are completely outside of the realm of what we ought to
be talking about here.

MS. SULTON: Greg?

MR. JAFFE: Dick\'s comment raised another issue in my mind on this and I
don\'t dispute what Dick said, but, it seems \-- I guess the question I
have about this issue is when we\'re talking about
transgenic-trait-sensitive markets are we talking about approved versus
unapproved products, or, are we just talking \-- because then I would
agree with Dick.

But, if we\'re talking about approved ones and people just don\'t want
to label them and so they\'re doing it for a commercial reason then I
think that the organic fits in with that category. So, I guess I was
reading this as not situations where \-- I was reading it as not just a
situation where one is exporting something and it\'s not approved and so
it has to be sent back, but, also things that were exported that have
been approved but people don\'t want to label them and so there\'s
commercial risk there because they may have to label it. It changes the
value of it.

Well, that would be \-- to me, that\'s identical to the organic one
where all of a sudden they would have \-- they would be exporting it,
but, they now have to \-- can\'t call it organic anymore. So, I guess I
would want some clarification as to whether this issue is solely about
approved versus unapproved, which is not just a commercial risk, but, a
regulatory risk. It\'s because of a regulatory \-- it\'s a regulatory
reason. It\'s a legal reason as opposed to, I\'ll call it, you know,
whether you want to call something organic or not, or, whether you\'re
going to label it.

If you eat or not, there\'s nothing illegal about labeling what you eat,
you just may choose for commercial reasons not to label it until you\'re
having a risk there. I think we need to make \-- I need some
clarification here from Ron or somebody else as to what we\'re trying to
cover in this one.

MS. SULTON: Daryl?

DR. BUSS: Well, I think, you know, our mission and goal for these topics
specifically is meant to pertain to biotechnology-related products. And
I think we ought to resist the temptation to draw in parallel
illustrations from all other sorts of things because we can go into many
of these topics and you could use other parallels other than organic.
You could use conventionally-produced. And I think where you draw that
line becomes infinitely difficult.

So, I think we ought to just focus on the biotechnology-related issues
as opposed to drawing in other things, whether it be organic or
otherwise. I just don\'t see that as our mission in this exercise.

MS. SULTON: Ron?

MR. OLSON: Yeah, I mean, I agree with Daryl. I think you can just make a
statement and if the USDA wants further answers it applies to all those
things. I don\'t know if we need to list them all. Just the fact that
biotech exists creates a liability risk because you have different
regulatory, different regulations evolving all around the world.

So, there is a liability risk somebody in the marketing chain has to
bear when you\'re trading in those markets, whether you\'re the
exporter, and that\'s where a lot of it falls today, but, the dollar
value, you know, rejecting a cob of corn in Japan because of one gene,
that is a very expensive rejection. And the exporter doesn\'t have
enough margin to cover that.

So, the question is, how does the liability shift occur and who bears
it? And that\'s the issue of where does the liability land over time. I
go back to the tracing and labeling report because the more you trace,
the more you have the ability to pass liability on. And, so, the
question is, who can afford to pay and where does it get?

And that, to me, was meant to be the guts of this issue as just saying
there\'s an increased liability that\'s out there that is undefined
today who bears that. We can give incidents where it\'s clear and we can
give incidents where it\'s unclear. And it\'s the unclear issues that
cause all the problems today.

MS. SULTON: Okay. If we could go to another issue \-- topic. Sorry.
Commercial differentiation between conventional and transgenic product
sources is creating demand for testing based assurance systems resulting
in significant challenges for the U.S. commodity merchandising system,
which I believe is what you were referring to, Ron.

Leon?

MR. CORZINE: Just kind of for my own information. We\'ve got several of
these issues that are issues, but, they\'ve numbered these and we
addressed labeling and traceability section. I guess, is it the intent,
even though they\'ve been addressed elsewhere, that we still list them
here? Just a question.

MS. SULTON: It\'s my understanding that the purpose of the two reports
were different. The purpose of the tracing and labeling report was to
explain the implications for U.S. manufacturers or producers who were
trying to export to foreign countries and the purpose of this report is
to list issues that the Department might want to consider if having
implications for the emergence of biotechnology in agriculture for the
next five to ten years.

So, yes, there would be overlap between the two. That\'s my
understanding. Dick?

DR. CROWDER: I don\'t know that it\'s necessary, but, I\'ll accept that
it is, but, I think we need to be careful as we go through what the
final draft on this thing to make sure that how it\'s constructed here
is consistent with how it\'s constructed elsewhere. We should not end up
with two different concepts and two different reports.

MS. SULTON: We will make a note to check that. Any comments on the
statement of this topic? Josephine?

DR. HUNT: Just a question really. Were there discussions on this
particular issue regarding the fact that there\'s no globally harmonized
testing methodologies?

DR. LAYTON: Extensive.

DR. HUNT: Okay. Because this, it\'s not explicitly defined there in the
issues statements.

MS. SULTON: Go ahead. Was it Alison speaking? I\'m sorry, I thought I
heard someone speak. It was explained. The testing thing was explained
as you\'ve seen in the other report in great detail. So, the discussion
took place in that committee. I don\'t know whether the issues committee
went into great discussion on testing or not, but, Abby\'s nodding that
they did. But, it was discussed in that workshop.

It has not been \-- this is the first time \-- it\'s not the first time
that this committee has addressed this because they did address it when
we were looking at the other report.

DR. HUNT: I guess my point, I think it\'s missed a little bit in the way
that the issue was worded today and I haven\'t seen it mentioned as a
specific issue or topic.

MS. SULTON: So, something more specific about the testing? I\'m not sure
I understand.

DR. HUNT: Yes. That would be my recommendation.

DR. SCHECHTMAN: Might I suggest that when we go back and ask for new
topics to add to the list after we go through these that perhaps make a
suggestion for some wording for that later on? Even acknowledging the
fact that it was discussed at some length in the other report.

MS. SULTON: Greg?

MR. JAFFE: I guess my view really, this is a stand alone report. I
don\'t have a problem with reiterating issues here that were done there.
I think the fact that we left them out without some statement that
specifically those were issues, I think this would, again, we\'d be
missing things that we should have in here and it would look like
they\'re missing, so, I am in favor of keeping something that\'s been
discussed in the labeling and traceability included in, although I agree
with Dick, we should have consistency.

I guess, and this is the problem, again, with sort of looking at just
these topics is, and this is where, I guess, I have problems with
Michael\'s only one sentence is enough kind of thing. I don\'t think
that one sentence is enough for these things because I read this
sentence and I\'m still not \-- if somebody asked me to explain
resulting in significant challenges for the U.S. commodity merchandising
system I\'m not sure what we would mean. That\'s such a broad thing. I
don\'t know what that is.

And I don\'t think we\'d do the Secretary a service just sort of saying,
you know, the first part and then \-- but then leaving that second part
open. They don\'t have \-- you don\'t give any examples of what are
those type of things and I guess Josephine has mentioned what I think is
one of them. It\'s harmonization. One of the challenges that different
countries have different testing. I think what she\'s talking about is
the globally recognized standard is the harmonization issue.

So, I guess I\'d like a little more discussion on what we mean by
resulting in significant challenges. What are those significant
challenges because I think that that would need to be articulated for
this topic to have it meaningful to somebody reading this report.

Without that, I think the insiders might know it, but, somebody else
might not know what is meant there.

DR. SCHECHTMAN: If I can just respond to one point that you made because
it\'s actually a very good point. And that is that the statements that
were written here, you know, were written for what was going to be, I
forget who said it earlier, the 30 minute version of the issues as
opposed to the three minute version of the issues.

So, there was a real attempt to smooth off all the rough edges of the
issue knowing that there was going to be a substantial discussion below
it. Now, they may need to be backed up a little bit with a little bit
more discussion but not as much as was here to make it clearer to people
so that people will understand what the issue is now that they\'re not
going to have anywhere from two to ten paragraphs afterwards to
understand what\'s there.

So, that actually \-- the context changes so the way some of them will
be worded will need to change.

MS. SULTON: Ron?

MR. OLSON: This issue, we\'re not going to stump the USDA on this one.
They already spend an inordinate amount of time on this. They\'ve had
multiple conferences. They are the lead. USDA is required to inspect all
export grain by law so they are the forefront of this particular issue.

They\'ve had multiple conferences on this. They are the ones that do the
testing. I mean, I don\'t think we could spend two days and not come up
with half the issues they already know. So, I think your telling
statement was, "Who is the reader of the report?" If this is the USDA,
we hit it right on the nose. If we\'re going to read it for the general
public you may need to expand it somewhat, but, the USDA is very, very
involved in this issue as are anybody in the grain industry so is all
over this one.

MS. DILLEY: Ron, to Greg\'s point is that the issue is the testing
harmonization. Further, other significant challenges.

MR. OLSON: The issue is the accuracy of the test, the sampling methods,
the timing of the testing. And if you just took export grain alone and
you just add wheat, corn, and beans together you\'re probably talking in
the neighborhood of ten million truckloads a day. We can\'t test \--
there isn\'t any instant test. A lot of these things that we have to
test for there are no instant tests. It\'s a three-hour test, it\'s a
two-day test.

Here you\'ve got 400 trucks in line; you can\'t hold them for two days
until you determine what\'s in every truckload. And, so, the
commodity-based grain handling system does not allow for waiting. It\'s
instant. Unless you have a test you can do, an ELISA or something that
you can do instantly there is no way to test effectively before you bin
the stuff because you don\'t have a bin for every truck. And there\'s
too much volume flowing through the system, whether it\'s domestic
export or at all to really test effectively for everything that\'s
evolved in the marketplace; transgenic world or you can pick any trade
you want, but, in the transgenic world you don\'t have time.

You don\'t have one test that tests for stacked traits so you might have
to run three tests instead of one test and the costs, the time, it
doesn\'t fit with the commodity based system today.

DR. SCHECHTMAN: Can I make a suggestion that with regard to this issue
maybe at the break we go back. There were a list of policy concerns
raised in the traceability and labeling document and maybe it would make
sense to go back and look at the statement, the way the statement was
constructed in that list of things that were specifically raised for the
Secretary and see if that fits specifically with the issue that\'s
raised here.

And we can bring it up again when we get back to the new topics added.

MS. SULTON: Josephine?

DR. HUNT: Yes. Just another point as to the list that Ron said there is
the point which you test along the food chain, you know, at the
commodity end you\'re using the ELISA type tests and as you go up the
food chain those become less appropriate so by the time you\'re testing,
for example, a product going from the U.S. into the EU you may be using
a PCR type test and agreements of these methodologies is not clear at
all.

MR. JAFFE: I just wanted to thank Ron. That\'s the kind of \-- I needed
that. I mean, you may know that, USDA may know that, but, since we\'re
all trying to understand I want to make \-- you know \-- make sure that
I understand the topic and I didn\'t understand it until I had a better
understanding of what those challenges were so that was helpful.

MS. SULTON: It does help us clarify what we need to do to expand and do
what Michael suggested during the break. Anything further on this topic?
If not, we have time for maybe one more before our break.

"Market access restrictions, including regulatory systems that consider
socio-economic issues, could limit the ability to capture value from
transgenic products."

MS. FOREMAN: I thought we deleted it.

MS. SULTON: Carol remembers we deleted that one. Does anyone else have
that memory? That\'s from your work group you deleted it? It\'s deleted
here.

MS. FOREMAN: It\'s either the one about the transfer of biotech products
to people in developing countries or the market access and we chose to
delete those issues.

DR. SCHECHTMAN: No, actually between the two there\'s one in brackets.

MS. FOREMAN: That\'s right. Sorry.

MS. SULTON: Okay. Disregard. So, again, the market, the access
restrictions, any comments on the statement of that topic?

DR. CROWDER: I think that needs one word change and that is that it
should say could limit, it does limit. I think we\'ve seen that already.

MS. SULTON: Mardi?

DR. MELLON: I don\'t understand this one at all. I mean, who\'s
capturing the value of the product? Does this mean that \-- I just
don\'t understand. Are we saying \-- I don\'t know. I just don\'t \-- it
seems to me that it mixes up a lot of topics in a very unproductive way
and I \-- unless there is a real, you know, crystal and nugget here I
would be comfortable in deleting it.

MR. JAFFE: I guess my question is, I\'m not sure what we\'re talking
about when we talk about market access restrictions. Therefore, the
clause, including regulatory systems, socio-economic issues, I\'m not
sure why we\'re singling that one out because I\'m not sure that is a
market access restriction or not. I mean, as far as I know the only
country in the world that has a regulatory system that currently
considers socio-economic considerations is Argentina and I\'m not sure
they really restrict it.

Most countries that are restricted don\'t have a regulatory system in
place or they haven\'t, at least, articulated a socio-economic reason
for \-- they haven\'t put forth a reason for denying access or
something. So, I guess \-- so, I don\'t agree with Dick\'s wording
change if we\'re using that including regulatory systems. Like I said,
I\'d want an example of a system that has looked at socio-economic
issues and caused a market restriction based on that in a regulatory
decision.

So, I guess I\'d like a better understanding of what we\'re talking
about when we talk about market access restrictions.

DR. CROWDER: Well, we may disagree on what socio-economic restrictions
is, but, the European position on the approval and import of biotech
products is surely not science-based and the scientists there will tell
you and it\'s a known fact that we lost a two hundred million dollar
corn market into the European Union so there is a specific impact.

I think the question then, Greg, is whether or not you would already
argue that European is scientific or socio-economic influence and so
forth, but, there is a two hundred million dollar corn market that was
lost in Europe for these items.

MS. SULTON: Greg?

MR. JAFFE: I don\'t have a problem with changing wording or talking
about moratoriums or lack of regulatory decisions. I\'m just saying that
those restrict market access and those prevent capture of value that
would be fine, but, when I hear market access restriction without that
context of what it was, if we\'re talking about moratoriums here or
talking about countries that don\'t have decisions or aren\'t making
decisions, I don\'t have a problem with that.

Again, whether that\'s socio-economic or not, I think we don\'t want to
\-- when I see the socio-economic issues things there that seems to me
they\'re wrangling with the Biosafety Protocol and things that countries
may be allowed to do in certain instances. I don\'t think any of them
does it one way or the other to know whether that\'s been the market
access restriction.

Clearly there are political things that went on in Europe. I guess I
would rather describe it as Dick\'s described it.

MS. SULTON: Mardi and then Michael.

DR. MELLON: Maybe we could just \-- I mean, I do think it\'s difficult
to characterize the European situation as regulatory systems that
consider socio-economic issues. So, we might just say market access
restrictions and then delete the next phrase and, but, then I would just
like to say limit the ability to sell transgenic products, meaning,
again, I\'m not sure who\'s capturing the value. I don\'t know what that
means other than being able to sell it.

DR. DYKES: I just want to respond to Greg. In the documents over on the
table, on page 11, it talks about a couple of examples of the system,
Argentina, South Africa. I don\'t know if you have that or not. In the
text, the previous text that Michael put on the table of how that\'s
socio-economic considerations. Just to answer your question, on page 11.

MR. JAFFE: Right. I don\'t think Argentina and South Africa would have a
situation where they have restricted access to markets. That was my
whole point. There are a few countries that have systems that have
socio-economic issues that they address those socio-economic issues.
They haven\'t actually restricted access to markets. I don\'t think
Argentina\'s \-- I don\'t know if Argentina has restricted their access.

DR. DYKES: It\'s restricted approvals.

MR. JAFFE: They have approved things. That\'s what I\'m saying.

DR. DYKES: Well, but, their approval process clearly links it to
economic consideration.

MR. JAFFE: I understand that, but, they didn\'t \-- they haven\'t
restricted a market based on that. They haven\'t said we\'re not going
to allow in U.S. corn because of that, that I\'m aware of.

DR. DYKES: Only if they delayed both soybean approvals and they delayed
a couple of corn approvals without a very specific point.

MR. JAFFE: Well, I like Dick\'s way of describing this as opposed to
using the word market access restrictions and looking at the regulatory,
the specific instance as economic.

DR. CROWDER: I\'m trying to say it wasn\'t my proposal. I was just
trying to give an example of a place where we lost market and I said I
didn\'t know whether we may disagree on whether he described it as a
socio-economic, a political, or, a non-science based. I\'m not \--
that\'s \--

MR. JAFFE: What I heard Dick sort of saying was something to the effect
of countries that have imposed moratoriums are not allowed the
importation of biotech products, have limited that ability to capture,
you know, the cross export of goods, to capture that value.

What I liked about it was that he was talking about a particular thing
here and in this case it was a moratorium by Europe or not making any
decisions; not that they\'ve made a decision and they\'re trying to
restrict the access.

MS. SULTON: Carol?

MS. FOREMAN: That\'s fine. I\'d be perfectly happy if you say based on
political considerations in that sentence.

MS. SULTON: So are we saying that market access restrictions such as
moratoriums, the EU moratorium on corn? Is that what you\'re suggesting,
Greg?

MR. JAFFE: I was trying to understand what we meant by market access
restriction.

MS. SULTON: By putting the examples in we\'ve just \--

MR. JAFFE: Or, talking about the situation and not mean the same market
access restriction.

DR. SCHECHTMAN: If I could understand, Carol, you were suggesting
something to the effect of market access restrictions based on political
considerations, is that what you were suggesting?

MS. FOREMAN: If you want to say the examples such as the European
moratorium.

MS. SULTON: Dick and then Josephine.

DR. CROWDER: I guess that if we would \-- again, we\'re not finalizing
anything today, but, market. I think market access restrictions and,
again, I go back to what Ron said a minute ago by telling USDA we\'re
not going to enlighten you on market access restrictions given \-- I
know that from \-- but, anyway, due to political or other
considerations, and I believe I\'d broaden it to the other, there are
other political considerations which would encompass some other options,
but, \--

MS. FOREMAN: You might include as other reasonable and real disagreement
about science. I don\'t think that was the case with the EU. I think it
was purely a political decision. But, if you use the term other you
might include a legitimate difference about what the science said.

MS. SULTON: Wait. Josephine and then Mardi, please.

DR. HUNT: Just a point. We\'ve been talking, the way I\'ve been hearing,
that the EU moratorium is still in place when, in fact, with the
instruction of legislation last April officially it has been lifted.

MS. SULTON: The restriction?

DR. HUNT: That\'s why I said officially. We were just having a
discussion and we were talking about the European moratorium as if it
was still in place when, in fact, it isn\'t. Officially.

DR. MELLON: I still would like to ask again, I mean, who \-- what \--
I\'m not sure why we\'re including this point. What does this \-- you
know \-- what discussions does this set up? In what way is this \-- I
mean, another way of putting it is kind of what are we telling the
Secretary of Agriculture that he doesn\'t already know?

I mean, I still think this is kind of a confused. You know, it\'s not
that it\'s not true, but, it doesn\'t go anywhere and since we have such
a long list I\'d like to say once again it might be one that we could
consider, you know, doing without.

MS. SULTON: Lisa, then Michael. Did you change your mind?

MS. ZANNONI: No. My comment was just to the moratorium because even
though they have approved products and they turned around and banned
both based on their science and then came out and set up what they call,
I think, there\'s still in effect a moratorium until things get in play
in Europe.

MS. SULTON: Michael?

DR. DYKES: I think this issue goes more to \-- I think it\'s both on
exports but I think it\'s also on commercializing products in other
countries that we\'re alerting the U.S. Department of Agriculture to.
And I think, again, if you look at the text of what we had before it\'s
clearly been the case in Argentina. Argentina\'s had a policy that
they\'re not going to approve products until they are sure that there is
no damage to economic markets with the European approval.

We\'ve seen it in numerous product approval. So, this is not just \-- I
agree with Dick\'s comments about two hundred million dollar corn market
the EU lost, but, it\'s also about commercializing products in other
countries that have policies as part of \-- economic considerations as
part of their regulatory approval process. It\'s just fact.

MS. SULTON: Okay.

DR. CROWDER: I just want to \-- I may not understand it clearly, but, on
the moratorium issue, just to pick up a little bit again, it\'s my
understanding that the moratorium has been officially lifted by
approving sweet corn and one other type of field corn, but, I don\'t
think there\'s a lot of commercial corn still moving because only
certain categories have been approved. Certain events have been approved
for feed and not have been approved for food yet.

MS. SULTON: We are, according to the agenda, to have a break in five
minutes and be back at 3:30 for the public comment. I don\'t know if it
make sense to just talk for five minutes about the next issue but I will
at least read it so you can think about it.

The next issue that we were to discuss is that of the next topic, "The
transfer of biotechnology products to people in developing countries
through humanitarian use licenses may provide important benefits, but,
the ability to gain humanitarian use licenses in the future is not
assured."

If we could come back like right at 3:30. If we could come back a little
before 3:30 so we can see if there\'s anyone here for public comments.
If there\'s not then we\'ll take up where we were on these issues. So,
it\'s now \-- I have 3:10 so if you could come back about 3:25 or there
that would be great.

(Whereupon, a brief recess was taken)

DR. LAYTON: It is now 3:30 and we\'re back in the meeting officially and
it is time for our public comment period. We do have a comment from the
public today. I\'ll introduce him in a second. I would like to reiterate
to the committee that during this time we will have the comments from
the person. It is not a time to dialogue or question or interact. It\'s
a time for comments only.

And that we hope that you will stay around for a while and, therefore,
after the meeting, if there is interactive time we\'d be happy to chat
after the meeting. And you have about five minutes for your comments.

We are joined today, and I hope I get the name right, by Dr. Canice
Noland. Dr. Noland is the first counselor for Food, Safety, Health and
Consumer Affairs with the European Unions and he is in the delegation of
the European Commission and I am assuming that you are situated here in
Washington, D.C. as a representative here.

Please join me in welcoming Dr. Noland.

DR. NOLAND: Thank you very much. Yes, my name is Canice Noland. I work
for the European Commission. I\'m based in Washington. I\'m in the
delegation and I\'m head of the section that deals with food safety,
health, and consumer protection. For those of you who know Tony
Vanderhagen, he retired a couple of months back, and I\'m replacing him
here in Washington.

My background is actually in pesticides regulation. This is the first
time I\'ve been out allowed in public to speak about biotech. I just
have a few comments. I won\'t even discuss this alleged moratorium that
you all were talking about. But, I do welcome the opportunity to
participate as observer and even to make comments to this group. I think
it\'s a highly commendable process that you have where you show such
transparency and inclusiveness. This is much to be welcomed and I wish
we had more of it back in Brussels.

This is an area where a lot of problems have existed between the EU and
the U.S. And it\'s an area where I think a lot more dialogue would be
very useful and very welcomed. There is an ongoing WTO case which over
the last couple of years has inhibited such dialogue. I understand
that\'s coming to a close in the coming months. It might even vindicate
our position; we don\'t know. But, once that comes to a close I would
hope that there can be a reopening of dialogue in this area of GM.

Now, I have a few comments. First, I understand that the role of USDA is
to promote U.S. agriculture and to make sure that the products of
agriculture are safe. In terms of safety, I think that the U.S. and the
EU have very high, very sophisticated systems to show or to assess
safety and to say, yes, this can go ahead, it is safe, or, no, this will
not go ahead, this is not safe.

I\'m not sure that we have actually to date rejected anything on the
grounds that it is not safe. We have made several decisions to let
things go ahead because they are safe in the EU and many more are
pending. Now, you may not like the length of the assessment process,
but, this is just our process.

And as the Deputy Secretary said today, we treat each other the way we
would expect to be treated. We in the EU reserve the right to have our
own safety assessment systems just as you in the U.S. have the right to
have your own safety assessment system and it\'s not just in the area of
GM, it\'s in all areas.

And, indeed, we could voice complaints about the length of time it
sometimes takes the U.S. in other areas to say something is safe, or,
something is not safe. Coming from the area of pesticides I am acutely
aware of the need to say science-based when you\'re talking about safety
because for many people in my experience we could have forgotten about
the assessments in the first place and just banned all the pesticides in
sight.

That was not our objective. We put in place a very extensive assessment
methodology and we stuck to it and people did not agree with the
outcomes, but, we went ahead and we said, this is safe. Not always
popular decisions. You are seeing this now in the EU now that this
alleged moratorium is over. We are actually starting to reach
conclusions and we are saying yes, this is safe, this can go ahead.

We don\'t always have the agreement of all the Member States, but,
that\'s the prerogative of the Member States. And this is something that
we still need to discuss with the Member States and look at basic issues
of basic governance and who makes decisions and on what basis. At the
moment we have a great system in the EU and the commission pushed ahead
with it.

Now, moving away from the safety issue and onto the issue of promotion
of U.S. agriculture, this is a completely different thing because here
we\'re talking about the 21st Century and the USDA, I guess, has an
obligation to promote U.S. agriculture, whether this is organic
agriculture, or, conventional agriculture, or, biotech agriculture. It
can promote all three.

In the EU \-- no, sorry \-- when you\'re promoting agriculture I think
you need to think about in the 21st Century we\'re going to have a
global agricultural production system and it\'s not going to be enough
to say I grow great stuff, you have to buy it. You\'re going to have to
think about the consumer and what does the consumer want.

At the moment in the EU the consumer does not want GM and the consumer
is paying a price for that. They\'re actually paying extra to have
GM-free food. Up to now we have a lot of discussions how to ensure that
the customer gets what they want. And we\'ve heard base science, based
on science, science-based. I have to admit that when I personally go to
the supermarket I don\'t have \-- you must have \-- it must be
science-based on the top of my shopping list. Neither does my wife,
neither does the average consumer. I just know what I want and what I
don\'t want.

And, sometimes, through clever marketing, I actually buy things I don\'t
want. That\'s something else. But, also the supermarket manager doesn\'t
make science based decisions. They fill the shelves on the basis of what
sells. And the processors sell to the supermarkets on the basis of what
the supermarkets think will sell.

And it\'s not going to be enough to say, well, wait a minute, this is
good for you and so you should have it, or, you should buy it.

The consumers will be more and more informed and will demand more and
more of what they want and I think that\'s the objectives that you\'re
going to have to work through is not to oppose informing the consumers
of what they want, or, what they don\'t want, or, what they should know
or shouldn\'t know, but, instead of trying to force the consumers to buy
stuff you should try to engage the consumers and actually get the
consumers pulling the process rather than trying to push the process.

That\'s just an observation. To finish, I think that in the area of
biotech we do need a dialogue. I am very, very encouraged by the
dialogue that has started in this area in the area of pro-tech. But, I
hope that we can also promote this in the coming months. I\'m new here
in Washington. I hope we can promote it in the coming months or in the
coming years of a more bilateral and open fresh dialogue. Thank you.

I will provide a written text if you like.

DR. SCHECHTMAN: Thank you.

MS. SULTON: Is there anyone else that would like to make a statement?
Okay. If there are no other comments from the public then we\'ll go back
to our discussion of our topics for our report. Thank you very much,
sir.

Okay. The topic before the break was the one that had to do with
humanitarian use licenses. I presume I don\'t need to read it again,
but, I will. Just give you a chance to read it over a minute and see if
you have any comments. If you numbered all this I\'m told it would be
number 12. It\'s the fourth from the bottom of page 6.

So, the point of this topic, is it clear to everyone what the point of
this topic is? Bob?

DR. HERDT: Yeah. This topic is fine the way it is and this may be
superfluous, but, actual property restrictions are one fairly small part
of the challenge facing developing countries and developing more
productive agriculture. Buying comes from people who need to eat more
food and have more income. So, I certainly don\'t object to a statement
like this.

But, just so that we all recognize that the actual property is not the
thing, the paramount problem. The paramount problem for developing
countries in accessing biotechnology is biotechnology that addresses the
crops and problems, the challenges that they face. That\'s the primary
problem. That\'s a research problem.

So, just to comment.

MS. SULTON: Mardi?

DR. MELLON: I\'m searching for a better word than developing country.
Developing countries are China, Brazil. They\'re fast emerging as major
competitors. At the same we know there are lots of other countries in
the world that I\'m not sure they\'re developing at all. I mean, they
seem to be sliding backwards.

But, I think statements like this, it\'s not \-- I agree that it\'s
clear the way it\'s written and I agree with what Bob said about the,
you know, kind of the circum \-- that we want to circumscribe in some
way and not think of it as the only problem, but, I think we need to \--
the world has changed under our feet and some of what we used to think
of as developing countries are now our competitors.

So, I want to know we\'re talking about when you say developing
countries. Are we talking about Brazil? Are we talking about China,
Indonesia, or, just Africa? When you read The Economist they now talk
about Russia \-- I mean, Brazil and India as the rapidly developing
countries.

MS. SULTON: Leon?

MR. CORZINE: I think Margaret\'s right. Hopefully in the WTO we can
straighten out some of this developing country definition and maybe we
will, maybe we won\'t, but, maybe it helps that it goes on to say
through humanitarian use license. Maybe that helps.

I don\'t know, Bob, whether that \-- whether you meant the one above as
far as intellectual property rights, but, I guess I question it may be
outside the ability to send products to other countries through
humanitarian use licenses and other programs that we have. It may not
have anything to do with biotechnology, but, it will have things to do
with where we end up in world trade as far as through MAP funding and
other export programs for humanitarian use or other ways.

So, I would say that would be more outside the realm of biotechnology
because I\'m not sure and I may not just be aware, I don\'t know if any
of those licenses have ever been granted or not granted because of
biotechnology. But, they may not be granted because of them being seen
as having an effect on trade or economy for other countries for whatever
reason, whether you agree or disagree, so, I don\'t know whether this is
needed where we\'re talking about biotechnology if that\'s what we\'re
addressing because this issue isn\'t really about biotechnology as I see
it.

MS. SULTON: Greg?

MR. JAFFE: Yeah. I was going to say this topic, I think, I guess I would
\-- it talks about the transfer of biotechnology products. That suggests
to me taking a product that was developed here and transferred it over
there and I think what was discussed over there before was a little more
broader than that.

I mean, these countries are developing their own products using our
technology or technology that was developed here. So, I\'d like to
capture that broader concept as opposed to sounding like the U.S. is
sending their product. This is solely limited to us sending products
that we develop here to those countries where I think the broader issue
is technology that may have been developed here being adapted and used
in developing countries for their own products.

You still need the same licenses. You may still need the same licenses
for those. The property that this is referring to is broader than just
the transfer of biotechnology products, but, it\'s also the transfer of
biotechnology \-- of the technology, the implementing technology.

MS. SULTON: Leon?

MR. CORZINE: Maybe it would be good for clarification of what Greg said
as well, whoever came up with this, are you talking about food aid or
are you talking about technology transfer?

MS. DILLEY: As I recall this was an issue that Dave Hoisington raised
and I think it was a combination of the two because there was a
technical transfer issue but it goes to the issue of which countries are
we talking about, which are the countries with food security or scarcity
issues. So, I believe it was within that context so it touched on both
aspects.

MS. SULTON: Michael?

DR. DYKES: Yeah, I thought it was more about the associated problems
with intellectual property rights and humanitarian use of patents and
there was some thought that because the patents blocked people from
transferring the technology to developing countries, and I agree with
what Mardi said about how that\'s applied, but, I thought it was meant
to people who wanted to take technology and use it for their own crops.
Certain patents block that and, so, these humanitarian use licenses was
an important avenue for the transfer of technology.

It was important that they be assured to people. That was my
recollection of kind of the general issue that IPR was blocking tech
transfer.

MS. SULTON: Pat?

DR. LAYTON: There was a fairly decent little write-up on page 10 of a
document that was compiled on August 5th and I think it was mostly about
the intellectual property holders so that was the consensus I think
where we were going. It\'s not consensus. It was sort of the explanation
that the working group had put down for consideration by the committee,
but, the committee never got to consider it or rule on it so I rescind
what I just said.

MS. SULTON: Anything further on this topic? Do we feel like we want to
keep it? Michael?

DR. DYKES: Just one comment, about the ability to gain a humanitarian
license in the future is not assured. I don\'t know, maybe we\'re into
words, that almost sounds like it\'s presupposing that there\'s going to
be a problem with whether you can get them or not so maybe it needs to
be stated that it\'s important that they\'re readily available or
continue to be available or need to improved \-- availability needs to
be improved or maintained or something.

But, it just sounds like it\'s portending that there\'s a real problem.

MS. SULTON: Bob?

DR. HERDT: Yeah. Unless I\'m mistaken, I don\'t notice any pieces in
which a humanitarian use license has resulted in a product
commercialized. Golden Rice is the poster child. Golden Rice is stuck in
the lab being improved. It\'s not out there. There is agreement that
most of the processes, if not all the processes, will be available in
the poorest countries under a humanitarian use license.

But, I\'m not aware of other cases, other products, so, and I\'m not
sure the role of USDA in what has happened on Golden Rice. So, that\'s
why I said, this is sort of a stand-alone statement. I don\'t know what
the Secretary will do with it.

MS. SULTON: Pat?

DR. LAYTON: If somebody can help me remember, I think that part of the
conversation, I think this was in the "Shriners meeting," we had the guy
from Purdue come in and talk about land grant universities and
intellectual property rights and how they want money for their
intellectual property now and I think it was tied to there\'s no such
thing as a free lunch and do land grant universities get paid to do
research and should it then be given out to the public and the poorest
countries.

So, I\'m thinking that there was some context around this issue that
went back to the role of USDA and funding. I\'m thinking, but, I don\'t
remember for sure, but, you all could help me remember, funding land
grant university research and intellectual property and all of those
things. I think it was all tied up with that also.

So, that was just what I was remembering.

DR. SCHECHTMAN: If I could just add to that for a second. I think there
were sort of two things. One, that research priorities that are in part
funded by USDA are partly tied up with the ability of researchers to
gain the flexibility to go beyond the lab work to actual products that
countries may wind up using was one point.

And, the second, that the issues here don\'t perfectly reflect
necessarily only things that are within USDA\'s purview, but, that
because USDA\'s responsibilities are so broad in overseeing agriculture
that there are things that the Secretary is going to be \-- is going to
have to deal with the ramifications of one way or another of whether or
not USDA\'s specific authority goes to it. I think that\'s how we were
talking about some of these things up until now.

MS. SULTON: Since this one doesn\'t seem to be noting what you mean, is
there a more meaningful statement that we could be making about this
issue because it sounds like there\'s something here but it may not be
in what was stated.

Greg, I don\'t know if that \--

MR. JAFFE: I was just going to say that I think USDA has a fair number
of patents in this area actually. They have, you know, them and their
researchers so they do have a role in how those patents get used and
whether they decide to pass things and put them in the public domain and
so forth so I think it is an area where they could set policy that would
have an impact.

MS. SULTON: Bob and then Mardi.

DR. HERDT: Yeah. A number of you might remember that a year or two ago
ten or twelve of the presidents of \-- the presidents of ten or twelve
of these major land grant universities and research universities signed
a statement agreeing that they would in a sense try to organize in the
future themselves to give specific use licenses for different markets
and reserve the use \-- reserve licenses of certain products for
humanitarian use or for in very poor countries or for minor crops which
seed companies may not be commercializing.

And, so, a group of university presidents agreed on whether USDA \-- I
don\'t think USDA was a signatory \--

DR. SCHECHTMAN: We were involved in the discussions. I don\'t know if
USDA firmly signed.

DR. HERDT: Yeah. So, I mean, I guess that\'s \-- this statement is
trying to get at that \-- you know \-- we need to be aware of that,
there\'s an issue there, there\'s a challenge in the future. I\'m not
sure, getting humanitarian use licenses in the future is not assured or
more difficult, is this going to be a continuing issue? These are going
to be case by case as far as I can \-- you know \-- as far as I can see
from what I see.

MS. SULTON: Mardi?

DR. MELLON: I think \-- I agree. I think part of this issue was \-- came
out of the Purdue discussion and it had a lot. What I remember is, is
what might be important to the Secretary of Agriculture is this kind of
feeling that a lot of scientists wanted to do some science to create new
whatever. I mean, you know, we got a ton of molecular biologists and
like surgeons operate, I mean, they need to modify and, so, they\'re
modifying a lot of plants and yet they were finding that they were
blocked in a number of ways from kind of seeing that research go to
fruition and it is a complicated problem.

I mean, it\'s not \-- it\'s not just that people \-- some people, you
know, want to do cassava and other people want to do minor crops or
whatever, but, that there was this kind of general feeling that there
were impediments from that \-- that they felt were out there and so
maybe we could reframe it like that or something.

But, I think that there is some frustration within the academic
community that there are \-- that they are hemmed in in terms of, you
know, what can come to fruition and, therefore, the kind of circle of
enthusiasm for continuing to fund their research.

MS. SULTON: Dick?

DR. CROWDER: I missed the Purdue discussion. I think I was gone. I think
what Mardi just described is a little different than the way I read
this. And I think that maybe the developing country issue, the products
issue, and so forth are issues in this language. I think it\'s
appropriate to include something along this line in here. It\'s just so
important not to, but, maybe by leaving out some of the terms it could
get us where we want to go.

And the transfer of biotechnology, transfer of biotechnology has the
potential to provide important humanitarian benefits to certain
countries or to a number of countries I should say and I wouldn\'t go
beyond the saying it\'s not assured and so forth.

I think the issue is, is we know that nothing is assured and the issue
is that this transfer has the potential of providing humanitarian
benefits. I don\'t want words submitted any further than that, but, I
think that\'s the point we\'re trying to make here rather than a
domestic licensing or availability or research funding system, I
believe.

DR. LAYTON: The Purdue discussion did specifically address the
intellectual property issues because you\'re not doing a thing on campus
these days that isn\'t going to make a profit. And he did speak
specifically to if we\'ve come up with a gene at my university and it
has value we\'re going to patent it and we\'re going to license it and
we\'re going to make as much money off of it as we can. I\'m sorry,
that\'s the way the world is.

And there was a discussion about can we allow humanitarian use licenses
in the poorest countries, which, I think, is said here, to some of
those. I thought I remembered that in the Purdue discussion. Maybe I
read more into than I did because I\'m coming from an academic
background and I knew what they were going to do.

MS. SULTON: Dick, did you want to respond?

DR. CROWDER: If I may. I don\'t disagree with any of that. I think it\'s
all happening, but, I don\'t think the Purdue discussion way is being
related to me is the point that this is trying to make. The point that
this is trying to make is just what you said, that licensing of
biotechnology has the potential of providing humanitarian benefits, I
like your word, in the poorest countries.

I mean, that gets to some of what it is. I think the other is a separate
issue.

MS. SULTON: Is it the licensing or is it the transferring or is IP
making it more complicated? Is that what we\'re talking about?

DR. CROWDER: My feeling is it ought to be licensing because it can be
humanitarian use license, but, we ought not to get away from the fact
that there is an owner of the intellectual property and the other person
is using it under a license where there is a fee, no fee basis, or, some
fee basis, or, something else.

But, the idea of the integrity of intellectual property ought to be
maintained.

MS. SULTON: Greg?

MR. JAFFE: I guess I must have missed the Purdue discussion on the
surface. At least I\'m not remembering what it was, but, I mean, I guess
the question in my mind is whether they\'re one topic or two topics
here. I think one is intellectual property and the transfer of licenses
is a topic. I think it should be a topic.

The question whether there\'s a more general thing about developing
country use of this technology and potential benefit, which is what I
thought I heard Dick say at the beginning, and he said included, might
be a separate topic and that\'s what Bob was trying to get at, that
intellectual property is only one obstacle. There are a number of
obstacles actually, biosafety is an obstacle.

You know, just general research capacity, a whole number of obstacles to
developing country absent to this technology. So, the question in my
mind is, I think we need to have the intellectual property issue in
here. I think that\'s a topic and I think it\'s relevant to the
Secretary for a number of reasons as we sit here.

The question is whether we want to have a separate topic in addition on
access or use of this technology by developing countries and I\'m open
to suggestions on that, but, I do think they\'re two different topics.

MS. SULTON: Are you suggesting barriers to the transfer among which
would be intellectual property, licensing, et cetera?

MR. JAFFE: I\'m saying that I think a topic that clearly should be in
this report is the topic of humanitarian use licensing and the
relationship between making sure that there\'s access in developing
countries to the intellectual property. The integrity \-- even the
integrity and so forth for that, that is an issue.

I think that is a topic that\'s going to be a major issue and continues
to be a major \-- will continue to be a major issue over the next five
to ten years over agricultural biotechnologies.

I think the Secretary should be aware of that and I think for a number
of reasons we\'ve mentioned the Secretary\'s going to have impact on
that, in part because USDA has a number of patents. They fund research
that has patents. They have ability to have some impact on that policy.

So, I think that that\'s a topic. I think that\'s separate than the
topic that Bob had been getting at or Dick sort of talked about which
was just generally whether biotechnology can benefit, has a potential to
benefit developing countries, in which case that \-- I think what Bob
was sort of saying, the question is, if you want to just highlight this
one as the barrier when there are a bunch of other barriers also to
developing countries accessing this technology and accessing not only in
the sense of transfer, but, accessing it generally in the sense of using
and getting benefit from it.

MS. SULTON: Michael and then Mardi.

DR. DYKES: I was just going to \-- I agree with what Greg\'s saying. I
think the whole issue of humanitarian use license is going to
intellectual property rights and technology transfer as one obstacle to
developing countries and I agree with what Bob said, it is only one
obstacle and there are many, many other obstacles.

Whether we want to go to the others or not, but, in my mind someone had
an issue that developing countries could not have technology transfer
because they were blocked on humanitarian use license, or, blocked on
patent and this whole area of humanitarian use license is in place to
try to address it. So, I think that\'s how this issue got framed. That
was an important thing.

I think it\'s going to the narrow thing. Whether we want to go to it
broader, other obstacles, benefits, all the other things that Greg
talked about, but, this issue was aimed specifically at how do you
address the concern that was expressed that developing countries are
blocked from having access to the technology. And the answer was
humanitarian use license.

So, I think it should stay in it.

MS. SULTON: Mardi?

DR. MELLON: Well, I think it should probably stay in there because it is
an issue that will probably be discussed, but, what is at the bottom,
what underlies it for me is kind of the extent to which the USDA
conceives of itself as having responsibilities to the world\'s poorest
countries.

I mean, is this the only thing that we\'re going to do for the world\'s
poorest countries? You know, is this \-- I just \-- this seems to float
out there apart from a bigger discussion of what it is that the U.S.,
with its gargantuan research, you know, budget \-- you know \-- what
responsibilities do we have to the rest of the world, especially those
who, you know, who are poor.

And, so, I don\'t know whether we just, you know, say that\'s not our
issue, but, it is, I guess, the one that bothers me is that this \-- you
know \-- that the \-- that it seems to be the most prominent thing that
we are doing. When we look at our trade policies and how they act to
disadvantage the world\'s poorest countries, the plight of poverty, and
poor farmers doesn\'t matter, but, here all of a sudden it does.

So, I don\'t know. I mean, I guess I would be \-- I could go along with
putting it in here as simply an issue folks are going to have to
address, but, I do think it begs larger discussions.

MS. SULTON: All right. Michael?

DR. SCHECHTMAN: A couple of points on that line. One that I would make
is that we had sort of a very fuzzy place holder for research and for
something having to do with research issues in biotechnology and
obviously that was one of the things that\'s sort of on the appendix to
this list here and the group did not address that. It\'s not clear that,
you know, how much clarity can be gotten on that recognizing fully that
it\'s a very, very big topic.

But, secondly, I mean, and this is more perhaps a little bit more in
direct response to your point, and that has to do with the fact that the
greatest part of the mission as funded by Congress for certainly
in-house research is research to benefit U.S. agriculture.

So, that\'s a very complicated question given who funds the research and
who makes the \-- you know \-- sets the overall guidelines for what
research is done in the U.S. That having been said, there obviously is
some work that is done and USDA scientists are doing \-- are certainly
doing some of the collaboration with others, but, there are limits and
that, I think, needs to be realized in the context of the point that
you\'re making.

MS. SULTON: The issue above also gets to intellectual property and if
it\'s all right we\'ll talk about that a little bit. This topic reads
that "International protection of intellectual property rights is
essential for the capture of sufficient product value to justify and
recoup costs of developing and marketing biotechnology products."

I\'ll give you a few seconds to consider that and then open it up to
your comments. Bob?

DR. HERDT: The international law, the international IP export, you\'ll
correct me if I\'m wrong, but, the word "international protection of
intellectual property" is misleading because there is no international
IP law. There\'s national IP. You guys in the industry have to deal with
country, country by country, so, if the committee is saying that USDA
ought to, or, the U.S. ought to push the world to create one single
international property protection system that\'s a big statement.

Otherwise, we need to do something with this.

MS. SULTON: Daryl and then Mardi.

DR. BUSS: Yeah. My recollection is that it wasn\'t with that intent at
all, but, recognizing a nation by nation event. So, I think it could be
reworded to make that more clear. I guess the question I had is whether
this begins to fall in the category of we hold these to be self-evident.
Where do you draw the line between just stating the patently obvious
because we\'re going to have a very long document at that point.

MS. SULTON: Mardi, go ahead.

DR. MELLON: I mean, I don\'t think it is patently obvious, although I
know it is considered an article of faith. To me you could \-- you know
\-- we have lots of ways of doing research and putting them out in
market and justifying recouping the costs of the research.

That\'s one issue, but, the other is that it certainly is not the case
that every country on earth has to participate in an intellectual
property system and basically pay above-market prices for products in
order to, you know, provide a sufficient amount of income to drive the
search.

I mean, you need \-- even if you accept the notion of \-- I think of,
you know, kind of royalties on patents as a patent tax. It\'s a tax on
products; it drives research; and it\'s one way to get that money, and
that\'s fine. But, the idea that everyone in the world needs to
participate in that system where the companies that develop these
products to have sufficient incentive to continue to develop products, I
think, is open for discussion and I think, in fact, it has been opened
on the drug side, you know, big time.

Not every country has to pay the very high prices for us to continue to
drive a very well-funded drug industry. So, I would say that \-- I mean,
I would certainly take out the idea of international protection. Maybe
we could say the protection of intellectual property rights is
considered essential or something, but, I really do think that this is
something that, you know, isn\'t \-- doesn\'t deserve the kind of \--
doesn\'t deserve to be accepted as an article of faith.

On the other hand, I\'m not sure it\'s a fight that we want to have
here. I\'m not sure that it gets us anywhere, so, having registered my
own belief I would also be comfortable if people, you know, just wanted
to move on because I\'m not sure it\'s a discussion that gets us
anywhere.

MS. SULTON: Dick?

DR. CROWDER: I agree with Mardi but for a different reason. I agree that
the topic is poorly constructed in terms of international protection.
Protection of intellectual property internationally is a much better
construction of that and I think that\'s what was meant.

This is a very important topic. It\'s very important for two reasons,
one of which is not included. It\'s important for recouping investment.
It\'s also important for insuring or helping to ensure the transfer of
technology to other countries. In the past five weeks we have had
requests from Argentina and Chile, from Kenya, from China, earlier than
that, India in terms of helping within the countries on intellectual
property issues so they could have access to technology.

So, this is not only a return on investment issue, it is an economic and
food development issue in a number of countries. The Congresswoman from
Argentina told me in the office two weeks ago that Roundup Ready®
soybeans, because of what happened in terms of rural development in
no-till and so forth, was one of the primary reasons they came out of
the recession they were in because of their increase in soybean oil
exports and so forth. I think that may have been a bit of an
overstatement, but, she made it anyway that Argentina has requested help
from us and we\'re going to do that.

I was in China last week. They want access to it, to cotton. They want
access to sunflower, corn, everything else. They can\'t get it until the
\-- at least what they want until then. So, I think that I would change
the issue to protection. And, by the way, Kenya, the permanent
secretaries of the Kenyan Ministry of Agriculture was in the office
three weeks ago and they were asking how could they change their system
also and they\'re interested in doing it.

So, I think this is an issue of not only to capture the value, but, also
to help and ensure the transfer because even under a humanitarian use
license you would want some assurance on the other side that that
license wasn\'t going to be abused in some type of way in terms of sold
to another country or something like that.

So, it\'s not an issue without depth and without importance in this
whole process and it goes beyond in terms of food development,
biotechnology into basic germplasm, also to increase the amount of
product that the biotechnology is helping to produce.

So, I think it ought to stay and I think it ought to be reconstructed to
recognize what Bob said that it\'s country by country and that it will
also influence the transfer of technology related to both biotechnology
and relate to germplasm also.

MS. SULTON: Any further comments? Yes?

DR. HERDT: This transfer of technology bothers me. We\'re talking about
selling seeds, aren\'t we? I mean, we\'re talking about selling
products. Why don\'t we just say sales. I mean, export markets. Because,
I mean, you know, transfer \-- I don\'t know \-- transfer \--

DR. DYKES: It could mean selling seeds.

DR. HERDT: Pardon?

DR. DYKES: It could be transferring genes.

DR. HERDT: But, I mean we\'re talking about selling products.

DR. CROWDER: If you\'re talking about exporting products from the U.S.,
no. If you\'re talking about Pioneer or Monsanto or Beck\'s Hybrids
selling its vegetable seed to someone introducing a new variety and so
forth in India that would increase production because the technology is
better and selling the seeds within the country, yes, you\'re talking
about that.

You\'re also talking about the willingness of people to go to places
like India and produce seed there and export them to the rest of the
world. So, you\'re talking about transferring intellectual property into
a country that increases the domestic and international potential of
that country, but, this is not only about exporting seed from the U.S.
It\'s about the use of seed companies\' intellectual properties \--
property around the world.

DR. HERDT: Now we\'re talking about licensing of properties. I mean,
I\'m talking about selling in the broad sense, licensing of intellectual
property, or, selling products, or, selling final products, or, rights
to use product. I mean, transfer of technologies, maybe it\'s meant to
convey a whole range. Maybe it\'s meant to be very broad in context and
maybe the definitions say that.

But, maybe we also need to be very clear on that.

DR. CROWDER: May I give an example? The Argentines, who are the largest
exporter of soybean oil in the world, do not have an adequate
intellectual property system. The Omega-3 oil is a technology. The
Argentines are very concerned that because of their lack of intellectual
property that that technology will not be transferred there and will
affect their position as a competitor in the soybean oil market in the
world.

That is a clear, just simple transfer of technology with no germplasm
transfer with anything else. At the same time you can transfer soybean
varieties, corn varieties, plant lines and so forth. So, it is transfer
of germplasm. It\'s strict transfer of technology. It\'s production
within the country. It\'s exports out of the country. It\'s the movement
of seed both ways.

MS. SULTON: If I\'m hearing you correctly, it\'s the lack of a system of
laws, of intellectual property laws such to facilitate the transfer of
technology and products? Is that right?

DR. CROWDER: That\'s what I think this statement says and I would add to
it that to effect the transfer of technology because it could be good
for us as well as good for them. I mean, nothing is better for us than
economic development and there\'s anything better for economic
development than a good agriculture.

MS. SULTON: Carole?

DR. CRAMER: I\'d just like to confirm I think it\'s broader than seeds.
Seeds are what we\'re doing now, but, there\'s other instances where
even in something like plant made pharmaceuticals someone in the U.S.
may have demonstrated that such and such will work and put, you know,
six million dollars into figuring that out, patent that, and somebody in
India can just read the paper because you patented it, therefore, you
published, and do it. You may get no return without a good system of
international protection.

So, I think you\'re talking broad technology here, not just the seed
industry.

MS. SULTON: Any further comments on this? Mardi?

DR. MELLON: It does presume a world very different from the world that
the USDA used to be a part of where research in staple food crops is
completely privatized and the interactions between people interested in
developing products based on that research, you know, is all done in the
context of these big private entities.

And that is a problem for a lot of folks and it\'s not the only model
out there. I mean, the other models that the U.S. followed for a century
or more, you know, had us with a very vibrant research base that
basically gave a lot of intellectual property away because we thought it
was good for our farmers and for the rest of the world.

So, and I don\'t \-- you know \-- I understand some of the benefits and
some of the particular kinds of technology that are advantaged by an
intellectual property system, but, I guess I just don\'t want to think
that this is \-- this is not the only way to do research and to transfer
it to other people so that they can help themselves or that we can help
ourselves.

It is a choice of the system that, you know, leaves behind the kind of
approach that has done us well in the past, but, I guess, saying it does
have implications for, you know, the USDA and its research
establishment. If everything that\'s being done is all to be privatized,
all to be patented, all to be dealt with in an intellectual property
system then I guess managing that system becomes a \-- you know \-- some
sort of a new mandate that USDA really needs to undertake.

MS. SULTON: Michael?

DR. SCHECHTMAN: Yes. If I could just make one response to that I think
from our perspective. I don\'t think \-- I mean, I think intellectual
property is, as a rule, generally being patented, but, I don\'t think
that necessarily precludes giving it away.

DR. MELLON: Well, I agree with that, but, you\'re still giving it away
inside of a system that I guess is a complicated one. I mean, what
you\'re giving away doesn\'t \-- as well know, the parameters of this
property are very fuzzy. It could be this big, or, this big. So, I guess
what I\'m trying to say is that I think it is important perhaps for us
to say that even if we can\'t do more than just say that it is an issue.

You know, say that the kind of increasing reliance on patents and
private companies for the development of agricultural research does have
implications for USDA and more in the future than in the past. It\'s
going to have to learn how to negotiate the system, how to accomplish
what it accomplishes. For example, giving away stuff in the context of
that system in ways that it never had to in the past.

MS. SULTON: Dick?

DR. CROWDER: Mardi, we could have a separate conversation on this
sometime, but, I think we need to be careful going down that road
because if you look at what has happened to research on germplasm and
plant technology and so forth in the U.S. since the introduction of
hybrids and since the introduction of the Plant Variety Protection Act
and since the introduction of patents you will see that the investment
in research in these items has increased many-fold and that the
productivity has increased.

And I would argue that that is not spurious correlation. It\'s cause and
effect. And other countries around the world who have adopted similar
intellectual property systems have seen investments in the development
of germplasm and technology increase on a comparable basis. And I think
that it would be well before we made a statement about a judgment of the
system and how it is, we ought to be very careful \--

DR. MELLON: I was trying very hard not to \--

DR. CROWDER: Okay. Okay. Then I\'m not so sure that I would agree that
it\'s fact, I mean, just given the results that we have seen. If I may,
I\'ll make one more comment. The international community, including the
FAO, is recognizing the importance of this. Three weeks ago I spent a
week in Tunisia on a material transfer agreement negotiation for the
United Nations as an advisor on how germplasm and materials should be
transferred and protected among countries and gene bank holders and so
forth around the world.

So, I think that globally the importance of intellectual property is
becoming increasingly recognized and the contributions that it makes to
productivity and to security.

MS. SULTON: All right. Shall we move to issue number 10 on transparency?
This topic reads, "The issue of the transparency in the regulatory
system will become increasingly important, especially to different
stakeholders\' perceptions of biotechnology products." I\'ll give you a
few seconds to contemplate that.

So, the question to you is the significance of transparency in the
regulatory system clearly communicated by the statement and do you \--
does everyone understand what was meant as being significant?

DR. SCHECHTMAN: Does that mean that it\'s completely transparent or \--

MS. SULTON: To stump the panel.

DR. SCHECHTMAN: \-- the opposite?

MS. SULTON: Ron and then Dick.

MR. OLSON: I was just reading the handout on this. The way it\'s stated
initially here doesn\'t seem to quite capture what\'s written in the
narrative. Maybe that\'s \-- the narrative talks more about developing
export markets and, you know, those kind of issues start evolving out of
there a little bit broader.

I don\'t capture that when I just read the way it\'s stated in the short
form and maybe that\'s okay and this will be captured and picked up in
bullet points later on.

MS. SULTON: Could you expand a little bit about what \--

MR. OLSON: It talks about increased transparency, more understandable
regulatory system which would help worldwide acceptance of ag biotech
products, who\'s carrying them out, and FDA should also be safety. You
know, a lot of it\'s on food safety issues that the consumer doesn\'t
get to read about what tests of the development company, whoever
developed the product or the grain that made it, this whole thing seems
to be kind of basically saying we don\'t get to see those tests. We
don\'t get to see those other than the USDA, FDA, or, whoever it is
that\'s doing the process. Just send it, okay.

MS. SULTON: So, reassuringly.

MR. OLSON: I\'m just saying it doesn\'t seem to quite match the issue. I
don\'t disagree with what it\'s saying, but, I don\'t know if we need to
re-word it or not or some of these points get picked up as a couple of
bullet points underneath as you expand them.

MS. SULTON: Greg and then Michael.

MR. JAFFE: Yeah, I was going to say that I mean, I think this is, again,
more examples of where we tried to make the topic statement sort of
generic or broad and expect some text underneath it to explain it. I
think if you just \-- I don\'t want everybody to assume lack of
discussion here doesn\'t mean that this one sentence, the way it\'s
worded, is sufficient for this topic because I do think \-- I mean, I
think you\'re right, that this had \-- I think originally this had come
in some part by Food Watch that talked about this trust-me situation and
this idea that, you know, they would be marketing foods but didn\'t have
the information behind them necessarily in the transparency and that was
going to be difficult for them, not just in the U.S., but, especially
internationally when they tried to explain to people why they had
certain things in their products.

And, so, I mean, I think this transparency is a topic that should be
discussed. I don\'t think that the statement that\'s involved here
necessarily because it has been watered down alone would capture it
again. I think you need a few sentences to capture sort of the extent of
the issue.

MS. SULTON: Along the lines that Ron says. As in page 9 of the text.
Michael and then Dick.

DR. DYKES: Yeah, I was just going to \-- Greg said it best what I was
going to say. I\'m not sure they match. I think if we\'re going to keep
that in there we need to think about restating the topic so that it\'s
more relevant to what\'s intended. I\'m not sure that the thesis that\'s
in the topic statement today is exactly true. I would say there\'s
really less interest in the biotech regulatory system today than there
was ten years ago that we measure by metrics, such as comments made
during comment periods and all those kinds of things.

There\'s far less interest today than there was ten years ago. But, I
don\'t think that gets to the issues that are within the body of the
text, so, if this is to stand the whole thing needs to be reworked.

MS. SULTON: Okay. Dick?

DR. CROWDER: Another process question. I thought that the text that was
handed out was background information and had no tie-in to what we\'re
talking about here.

MS. SULTON: In this case, whether you bring it up verbally or whether
you refer to it in the text you\'re informing us that we need to \--

DR. CROWDER: Okay.

MS. SULTON: You know, we\'re looking for a way to inform what was meant
by this and I think what Ron was doing was giving us a source and what
we then need to know is do everybody agree that given that source
that\'s what we were trying to say.

DR. CROWDER: Okay. So then in contrast to what we read earlier we need
to go back and read that source so that we\'ll have it as background,
our own background. Okay. MS. SULTON: What we said is you could take a
look at it and see if that would help and, if so, offer it up or not.
But, it was not meant to be text that we\'re definitely going to use
unless it\'s brought to our attention that we should.

Leon?

MR. CORZINE: Along that line, how we use this text, this text, I assume,
\--

MS. SULTON: This text?

MR. CORZINE: \-- the one that expands, I assume there\'s nothing in
there that anyone will consider that was anything senseless or agreement
by this group because there\'s some pretty inflammatory stuff in that
text I would say that I would hope that would be the case.

MS. SULTON: Around this specific issue, Leon?

MR. CORZINE: Yes.

DR. MELLON: Where is it?

MR. CORZINE: The paragraph before the one that Ron referred to, if you
want it specific, Margaret.

DR. SCHECHTMAN: Again, the text \-- you know \-- if there are ones that
are being a sentence or a piece of text that the group wants as a whole
to take out of this there is nothing that prevents the group as a whole
from doing that. But, this, the text itself, has no status as an
official version of anything.

MS. SULTON: It\'s referenced.

MS. DILLEY: I think that mostly there are a lot of different dimensions
to the issue of transparency and to get a sense of that look at the
text. That\'s all it was.

MS. SULTON: And then my question to you is, do we want to include any of
that? I guess what I need to know now is to know \-- I think what I was
hearing before is that this is something that needs to be clarified
beyond the one sentence that was here and one place we might look is the
part of the text so in that consideration when we figure out our work
plan we\'ll figure out whether we use it or not and, of course, at that
point things \-- the discussion of what was appropriate or inflammatory
or would be re-argued.

MR. CORZINE: I guess in that, and I guess if we\'re not going to re-work
this right now, but, it seems to be it\'s a pretty simple issue and I
would question somewhat in that becoming increasingly important. The
transparency is important now. And the statement that transparency is
important in the regulatory system would pretty much cover it.

MS. SULTON: Greg?

MR. JAFFE: I guess I would want more details of what we mean by
transparency and, therefore, why that is important. And, so, I just
think we need some other text around that. I guess from a process thing,
I mean, again, I\'m assuming all of these topic statements we have here
are going to be re-worked and all of them are going to be added to.

You sort of said \-- you said \-- you said something \-- you made a
statement whether this one or this one statement. All of these, I
assume, are going to capture all of the discussion we\'ve had about them
and how these are going to be re-worked and we\'re going to decide how
to do that. So, again, we\'re not wordsmithing single one-line
statements here, but, we\'re having discussions about these topics,
deciding on the topic, and then we\'re going to write a discussion of
the topic based on the discussion \-- write statements about the topic
based on the discussion we\'ve had here which may encompass some of
these words that are on this page and may not encompass some or more of
these words.

MS. SULTON: That\'s correct. I was just saying that if someone wanted to
specifically refer to wording that we might consider then we\'d
certainly be open to considering that. As Ron pointed out, that one
paragraph, that he was suggesting that we take a look at.

Brad?

MR. SHURDUT: Yeah, and this is going to be real brief, but, I know
we\'re not wordsmithing or looking at details there, but, the one thing
you just may want to add here, which was brought up in one of the first
comments, is in addition to the safety of biotech products. Just leaving
it broad perception, it\'s really not what we\'re getting after. You
know, perception\'s really to the safety of biotech products. So,
transparency around the regulatory system and what we do from a risk
assessment standpoint lodge that in there somewhere and it may be any
easy wordsmith that would catch everybody\'s opinion here.

MS. SULTON: Okay. Mardi?

DR. MELLON: Well, I guess one of the most important things I think we
ought to elaborate on is \-- I mean, I agree with Leon that we can kind
of just say transparency is important to regulatory systems as the
headline, but, I think we \-- I don\'t know, I would think that we would
want to give the Department, you know, a kind of heads up on the
concerns about the lack of transparency in the systems that are
available to look at animals.

To me, that\'s like a huge issue there is that the drug system that\'s
being used to regulate animals is by definition, you know, completely
opaque and that\'s one, again, without saying what we need to do about
it, if anything, that we would want to kind of offer.

MS. SULTON: Carol?

MS. FOREMAN: I think that if we had the statement that we have a lack of
transparency and it\'s a concern that we could then follow with some
bullets that are examples of the lack of transparency. USDA not making
available notifications or permit applications. FDA\'s maintaining \--
not providing data until the end of the process and then very little.
The problem with the animals, the system being completely opaque which
would explain the first statement and make the issue coverage a lot
shorter.

MS. SULTON: Any further comments on this topic before we go on to topic
number 9? Leon?

MR. CORZINE: I guess I would just say that we want to re-work the
sentence is fine, but, I think we want to stay away from opinion things
like lack of transparency. We could just say transparency is important
because we could get into a discussion we would never end as far as how
transparent we are, may or may not be, and can or cannot be, but,
transparency\'s important.

MS. SULTON: Carol, go ahead.

MS. FOREMAN: I think if you said it\'s important then you have to cite
places where there is no transparency now. The approval of transgenic
animals is not under dispute. It\'s being nobody disputes it. They may
dispute whether or not you should do it another way, but, the law says
that in licensing a new animal drug you may not release any of the
information until the license is granted.

So, the lawyers all agree on the legal situation. The issue debate there
is about other subjects. But, nobody, I think, has ever disputed if
there is completely opacity there. Is that a word?

MS. SULTON: We understand what you mean. Greg, please.

MR. JAFFE: Yeah, I mean, I think if you want to do a report that\'s
beneficial to USDA to just say transparency is important without putting
a biotech context around that, it's not meaningful. We could do that
with all these other ones. We could say, you know, market access
restrictions are bad. You know, or, I mean, exist. I mean, all of these
could be intellectual property is important.

I mean, the whole point of this is to take \-- is to move down \-- I
mean, I guess I\'m \-- that kind of generality I don\'t think is
beneficial in this report. We have to, as Alison said before, make it
biotech-specific and relate it to the issues of why is this important in
the next five or ten years, or, why is this going to be an issue that
the \-- I look at this and we still haven\'t talked that much about is,
you know, what\'s sort of the sieve for deciding why are we talking
about these topics and the sieve, I thought, we\'re going through is
it\'s something that\'s related to agricultural biotechnology that the
Secretary\'s going to have to \-- going to hear about in the next five
years, five or ten years, as new products come forward.

And I think what Keith \-- if Keith were here he would have said, you
know, I have trouble going and marketing these products worldwide
because our system\'s not particularly transparent and so people, when I
tell them it\'s safe, people can\'t go and look and find out for
themselves that it is safe or why, what was the basis behind that safety
decision.

And we may not have to go into the details and saying, well, in this
particular case USDA doesn\'t make this particular permit available or
something like that, but, I think the concern he was raising is one I
agree with and it\'s out there and it\'s going to continue to be out
there for the Secretary and for the U.S. system and that is that there
are places where there aren\'t \-- it isn\'t as transparent as it could
be and that is hurting worldwide acceptance of this technology.

It\'s hurting consumer acceptance in this country about this technology
and that\'s the issue that we want to make the Secretary aware of. And I
think there are ways we can do that in a neutral way, but, if we\'re
going to go down the road of we can\'t criticize any part or comment
about facts about the system and I think we\'ve been doing that on other
parts about the intellectual property, about market access, about
liability insurance, all those were more detailed discussions of how a
particular broad principle or statement is affected by biotech crops.

We have to do that in this case also. We can\'t begin to make
distinctions because we\'re getting into a regulatory context and we
want to hold back from it.

MR. CORZINE: My point is and I don\'t disagree with what you say, Greg,
and maybe we need some examples like Carol mentioned, but, if you start
making statements like in this \-- this really grabbed me \-- convoluted
nature of the U.S. regulatory system. You can\'t even \-- you can\'t go
down that path or we might as well quit the discussion now.

That\'s my point.

MS. SULTON: So, biotech specifically with some examples of why it\'s
significant just to explain it, but, not necessarily to be judgmental.
Abby, did you want to say something?

MS. DILLEY: I just think there were different meanings of transparency
and those might come out as different sentences and I think we can do it
in an even-handed way. So, I think that\'s the next task of what we need
to do to work on that sentence.

MS. SULTON: We\'ve heard it, I think, enough to know what we want to do
here. Dick?

DR. CROWDER: Just a quick observation. While we were talking about this
I happened to read up a little bit and we talk about the issue of
animals up above. We talked about plant made pharmaceuticals above. So,
maybe as we get through some of this, some of the concerns may already
be covered in a different place.

MS. SULTON: This is a segue to topic number 9, "Future products,
by-products, and events associated with agricultural biotechnology may
create urgent needs of the regulatory system and process to respond to
any very rapid, effective, and coordinated manner."

A few minutes to contemplate and get your comments on it whether it\'s
clear with that statement is enough.

Alison?

DR. VAN EENENNAAM: I just wanted to get clarification of what type of a
scenario you had meant with regard to urgent? It looks like you wrote
it, Daryl. I was just curious. Do you mean products coming in from
overseas that are genetically engineered but not approved here?

DR. BUSS: I don\'t think it was \-- well, it was driven by a discussion
where we were talking about several contexts. One context was the
potential for multiple federal agencies to be involved in regulation,
depending on what the nature of the product was and a concern that some
products might well fall between the cracks, between agencies. That
stemmed to the coordination piece of it.

And then related to that coordination, if that requires coordination is
that going to be sufficiently timely to be able to respond in a rapid
way. It doesn\'t mean it isn\'t, but, I think that was the context as I
recall it that arose.

DR. LAYTON: I was going to say rapid doesn\'t mean two days. I think it
meant not five years.

DR. BUSS: And it was also driven by the discussion of concern about the
system being driven by products we now know and relatively understand
and is it going to be set up to handle those things we don\'t now
foresee and by definition you don\'t know what those are. So, that\'s
where, again, the interagency cooperation or cross linkages came up for
discussion.

MS. SULTON: Alison, does that \--

DR. VAN EENENNAAM: Not really, so, just to get a clarification. For
products developed in America or for exports coming into America?

DR. BUSS: The context was meant to be either direction.

DR. SCHECHTMAN: As I recall, one of the things that came up at about the
time that this topic was mentioned was glowfish® which had just hit the
news and one of the former committee members was very anxious to read us
the article about glowfish® having appeared the day before or two days
before our meeting.

MS. SULTON: I think I recall that and possible legislation state by
state. Carol, did you want to respond to this?

MS. FOREMAN: No. Actually I was going to ask a question, but it was
answered.

MS. SULTON: It was answered, okay. Does anyone else have a comment or
question on that? Lisa?

MS. ZANNONI: I think that future products I think you\'re talking more
about novel products, something along those lines. Because when I first
read this about going back I thought this talked about responding, an
agency responding, to an unapproved event or something like that which I
think this is more the novelty of something might not have a system
created for it yet and that the agencies have to find a way to evaluate
it effectively.

It\'s not really responding. It\'s evaluating it.

MS. SULTON: Let\'s see. I see some heads nodding in affirmation on that.
Greg?

MR. JAFFE: I mean, I was going to say for this topic I think Daryl did a
good job of summarizing it. I think the statement may not do that when
he talked about coordination issues, timeliness issues, and sort of
making sure things don\'t fall through the cracks. So, I think that
those \-- I think without some collaboration on those three things the
statement is of itself doesn\'t give you that impression.

So, either we have to re-work the statement, or, incorporate it in those
three things because I think those are all important messages to give it
to the Secretary that, you know, coordination\'s going to become very,
very important. Timeliness is something that needs to be looked upon and
also making sure that things like the glowfish® or whatever don\'t fall
through the cracks. The novel applications are important.

So, I think that was the point of it.

MS. SULTON: So, with that, are we ready to move on to another one or are
there any further comments or questions on this topic? Okay. Number 8.
"The extent of application of biotechnology to minor crops is highly
dependent on the cost of product development and the unique
characteristics of minor crops."

I\'ll give you a moment. Dick?

DR. CROWDER: I suggest we delete it. We have a special request from the
Secretary on minor crops and I don\'t know what this is going to add to
the discussion.

MS. SULTON: In light of the upcoming request does anybody concur or
object to the suggestion, the argument of keeping this in this document
right now? Greg?

MR. JAFFE: I guess I\'d like to at least reserve judgment to hear more
details about what the topics are suggesting because they \-- I don\'t
know enough about what the topic is here that the Secretary wants an
additional report on to see whether this overlaps that.

And I think even if it did, that doesn\'t mean you wouldn\'t include
this. I don\'t know what the timing is for those reports. They\'re not
going to begin until after this one is submitted. My understanding is
they don\'t start work on these until 2006.

So, just like we might be repeating things on global labeling and
traceability here, it seems to me that if this is an issue topic we
should put it here and somebody justifies it than doing a more detailed
report on it. I wouldn\'t spend a lot of time on it, but, I think you
would want to include it.

And, to me, one of the things that was \-- what I remember about the
discussion in this one was, and particularly we talked about things
like, I don\'t know, a discussion of genetic engineered lettuce and
because of the kinds of variety and things like that you may in the
aspect of lettuce you may have to do many more approvals because you
can\'t just backcross it into different varieties in the same way that
you can do with corn and things like that.

There are actually scientific reasons for maybe reviewing how the
regulatory process deals with some of these crops because the regulatory
burdens were significant and I don\'t think that\'s the topic of
discussion that the Secretary wants in this new report, but, again, I
don\'t know.

MS. SULTON: Dick and then Mardi.

DR. CROWDER: Well, I just would like to respond to, first of all, what
we were trying to list issues that make the Secretary aware of and,
secondly, I don\'t think that the topic as written here reflects the
same topic that you just discussed. This says the extent and application
of biotechnology to minor crops is highly dependent on the cost of the
relevant and unique characteristics of minor crops.

I don\'t see a lot of value ahead of it. I don\'t see that running into
science and so forth that you were talking about.

MS. SULTON: We\'ll come back to Greg in a moment.

DR. MELLON: I remember on this topic was just a discussion about how we
contrast corn, which is a 70 million acre crop; you know, lettuce is a
\-- help me, somebody who knows \-- you know, maybe \-- is 1,000 acre
crop; and, so, if you are going to pour R&D costs into lettuce your hope
of being able to recoup those costs with some sort of premium price on
that lettuce is \-- you know \-- you got to have something a lot better
than DT in order to really drive the cost of the research going into the
small \-- to products which have such small markets.

MS. SULTON: Abby is saying that\'s what she recalls as well.

MS. DILLEY: It\'s that last, second to the last sentence on that page 7.
That\'s exactly what Mardi said which is if you\'re talking about \--

MS. SULTON: Michael\'s \--

DR. SCHECHTMAN: Yeah, I\'ll just read that sentence. It\'s not that this
piece of text has any \--

MS. SULTON: It\'s not binding.

DR. SCHECHTMAN: It\'s not binding, but, it says consequently, if greater
application of biotechnology to minor crops is perceived to be a need
these factors, things like size, unique characteristics, then added to
the marketplace in the previous sentence, will require mitigation in a
way that enables the application of biotechnology to minor crops without
compromising safety.

That\'s what the sentence says.

MS. SULTON: Any affirmation for that point. Any other comments on this
topic and its inclusion in the list? It sounds like we\'ve gotten back
to \-- Dick, do you feel better about including it now?

DR. CROWDER: No.

MS. SULTON: No.

DR. CROWDER: I mean, I read what you just said or read what the
Secretary read and \-- one second.

MS. SULTON: Okay. We\'ll work that out at the next date. Any other
comments on this? Okay. Now, it\'s about two minutes to five.

MR. JAFFE: I was going to ask if we\'re going to do a time check and I
guess I would offer that we don\'t start the next topic at this point.

MS. SULTON: That\'s what I was about to do too. So, we concur on it. I
was about to \-- I wasn\'t going to make a decision, but, to say that it
is now five o\'clock and \--

(Discussion off the record)

MS. SULTON: So, it is the pleasure of the committee that we will resume
discussion in the morning. Michael?

DR. SCHECHTMAN: There was a request earlier in the day that was made to
hear our tentative dates that we\'re going to suggest for the next
meeting. Based on looking at everybody\'s schedule now it\'s worth
reminding everyone that as usual there is no dates that fits everybody.
There are no dates that fit everybody but one person, but, the best
dates that we have looking at everyone\'s schedule are tentatively
October 24th and 25th and sometime in the range between December 13th
and December 16th. Those were fairly free with everybody.

I would say the October 24th and 25th dates are tentative. After this
meeting if people largely still have those dates available those dates
are tentative only to the extent that we\'re going to have to find a
place to have the meeting and that\'s not always trivial. This will be
somewhere in the two days in the range of December 13th through 16th.

DR. BUSS: Can I ask, I guess, the reverse question. I need to release
some of the dates on which I have holds so if we can release \--

DR. SCHECHTMAN: We\'ll have a discussion on this tomorrow. I just wanted
\-- someone asked. You will all go back and consult your calendars and
we will discuss that tomorrow.

MS. SULTON: We are to convene tomorrow at 8:30. We\'ll have this
wonderful coffee discussion in the morning so you can come earlier if
you\'d like, but, we would like to start the meeting promptly at 8:30.
And we\'ll start with issue number 7, I think it was. All right. Have a
pleasant dinner.

(Whereupon, at 5:00 p.m., the meeting was adjourned to reconvene on
Tuesday, August 9, 2005 at 8:30 a.m.)