> UNITED STATES DEPARTMENT OF AGRICULTURE
>
> WASHINGTON, D.C.
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--x
>
> :
>
> ADVISORY COMMITTEE ON :
>
> BIOTECHNOLOGY AND 21ST CENTURY :
>
> AGRICULTURE (AC21) :
>
> TENTH PLENARY MEETING :
>
> :
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--x
>
> A meeting in the above-entitled matter was held on Tuesday, October
> 25, 2005, commencing at 8:30 a.m., at USDA, 1400 Independence Avenue,
> S.W., Room 107-A, Jamie L. Whitten Bldg., Washington, D.C. 20250.
>
> Dr. Patricia Layton, Chairperson

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

MS. TUCKER FOREMAN: Before we get too far, I know we\'re going to do
something else first, but, I did want to say, because I was doing this a
little late last night, there\'s a plural verb where there\'s just a
singular one and a couple of other little things like that.

DR. LAYTON: Now, we\'ve finished all of page 5, right? I have notes all
over it so we are \-- when we get to the introduction again we\'re at
the top of page 6 which is where you have suggestions. And I still
didn\'t get copies of that. Are we still waiting for them?

(Discussion off the record)

MS. SULTON: Before we can all get a feel for what we are going to try to
accomplish today by going over the agenda again because we need to make
a few changes. I believe it\'s the view of the committee that we
continue and complete the introduction so we are setting aside until
about 10:15 to complete our work on the introduction and Paul will be
facilitating that and I work the changes on the machine or on the
screen.

We\'ll have a break about 10:15 and then we\'ll come back to discuss the
issues. We went over the issues last night and decided that we will just
proceed with them in the order in which they are written starting with
the ones that are somewhat new because we haven\'t had a chance to
discuss them before.

And we\'ll talk a little bit about how we might approach the issues
after the break. That will take us all the way until about 3:30 at which
time we\'ll need to close and put together a work plan for how we are
going to complete this document between now and our next meeting in
early January.

So, everyone agrees that\'s the agenda we\'d like to follow for this
morning. Any questions about that or any suggestions? Okay. I\'m going
to turn it over to Paul and switch places.

MR. DEMORGAN: Yeah. I just need to facilitate.

(Discussion off the record)

MR. DEMORGAN: Okay. So, good morning. Welcome everybody. Hope you had a
nice dinner.

(Discussion off the record)

MR. DEMORGAN: Anyway, okay, so as Cindy said we\'re going to go right
back into the introduction with the objective here of reaching closure
on that before we wrap up for the \-- before we turn our attention back
to the issues.

And so where we left off yesterday was we had made it up to \-- we made
it through pages 1, 2, 3, 4, and 5, and so the way I had been measuring
that was that we\'re actually on what I call the tenth paragraph so when
I was doing the flip charts yesterday I was doing it by paragraph so the
tenth box here. So, we\'re on this tenth box, AC members have diverse
views as to the proper role.

And as Pat already mentioned, Carol\'s got some suggestions for each of
the remaining paragraphs and I\'m sure others have some comments and
questions on the box as well. So, Carol, why don\'t I just turn to you
to offer kind of your observations, your thoughts about the changes that
you\'re suggesting the group consider.

MS. TUCKER FOREMAN: Okay. Thank you. First, I tried to shorten it
somewhat by taking out fewer words where I thought that was possible. I
noticed that Alison, I thought, had raised a good point about some
consumers have been more aware of. Since we\'re making it a point that
the marketplace has changed I thought it was worthwhile to say a little
bit about what has changed in that marketplace. So, I made reference to
the advent of cable television, you know, 24/7 news coverage and
channels completely devoted to food.

Then a reference to the fact that the debate about the U.S. regulatory
system has kept this issue before the public off and on fairly
regularly; that some new products may raise ethical and moral concerns
that just aren\'t addressed by the regulatory system or by science and
suggested that it\'s necessary to find \-- to secure public approval to
the products.

Made a reference to picking up from the other document, especially the
outcome of Codex and Cartagena. That\'s the first paragraph. I have
tried to keep all the information that is in the original but I
condensed it in some places in order to condense a number of words.

And you want me to go to the next one or just stop here?

MR. DEMORGAN: Well, just from my \-- Alison, you had a question?

DR. VAN EENENNAAM: I guess I have more of a process check which seems to
be the word that the committee uses.

MR. DEMORGAN: Sure.

DR. VAN EENENNAAM: I had understood that we were going to go through
this and that we were to have comments back on our edits to Pat by a
certain date that was made clear to the whole committee and then we
would go through those at that time and now we\'ve been given a totally
new wordage on a, you know, fairly substantial changes on the day of and
that wasn\'t the process that I think the committee had agreed to.

And, so, I just want to understand. Is it, you know, I\'m thinking on
behalf of perhaps it did go through and do the edits based on that. I
feel like that was a bit of waste of time because now we\'re just going
willy-nilly and getting new input and, so, I guess I need an
understanding of where we are with regard to that process.

MS. TUCKER FOREMAN: I think it\'s clear that we\'re going to go through
the document as originally prepared. I was asked to comment on something
that I have proposed. I didn\'t assume when the document came that the
format was locked in, the structure was locked in.

DR. VAN EENENNAAM: Well, I think it\'s not that so much as \--

MS. TUCKER FOREMAN: That the editing columns really limit you to trying
to deal with the language. But, you know, if the committee doesn\'t want
to deal with this that\'s fine. Your points are well taken.

MR. DEMORGAN: So, Alison, I guess a couple of thoughts. One is
especially how yesterday unfolded, clearly people who had submitted
comments, including folks who aren\'t here, we referred to those, people
looked at them, and they were very helpful in moving the conversation
forward. But, clearly, others who hadn\'t commented participated in the
conversation and worked the language.

Carol did submit comments, I believe, but, not within the arranged time
frame originally and now she\'s got comments, just like any of you might
have today, and, I think, you know, my understanding behind Carol
putting this together was rather than, you know, just explain it all
verbally she wanted to show you the specific changes.

But, what we have on the screen is the original document and what we\'ll
work on is the original document. And, so, in essence, all I see this as
is Carol\'s verbal comments put in front of you. Now, I admit, if all of
you had done this, all of the folks who had done this, we\'d have a very
\-- a much more difficult situation to overcome and I guess your point
is very well taken and I guess I would encourage all of you, as you
figure out a work plan moving forward, that if you set deadlines that,
for the sake of the group, you try to meet those deadlines and try to
get your comments in on time so that Pat can do her work as you\'re
suggesting.

But, in this instance, I guess, you know, it seems to me she\'s really
putting some issues on the table and then we can discuss your comments
and anybody else\'s comments and see what we want to do with the
specific language. Is that okay for now recognizing that it is a little
bit awkward?

DR. VAN EENENNAAM: Yeah. Okay.

DR. DYKES: What is the process here?

DR. SCHECHTMAN: We will be working from the original Chair\'s text that
was circulated. To the extent that as Carol mentions things in the
document as it\'s presented we can see those and the committee can
decide what to do with suggestions that come in and how to incorporate
things that the whole committee can agree on into the text where
appropriate.

MR. DEMORGAN: Is that okay?

DR. VAN EENENNAAM: Okay.

MR. DEMORGAN: Carol, if you could just, in one of the questions I had
for you was, I\'m looking at paragraph 10, as I call it, the top of page
6, basically takes up everything but that last line on this document.

MS. TUCKER FOREMAN: Are you trying to \--

MR. DEMORGAN: Yeah. We\'re just putting it up on the screen and it\'s
this document and what I\'m trying to understand personally is your
first page. Is your proposal is that you replace all of that with this
thing?

MS. TUCKER FOREMAN: Yeah.

MR. DEMORGAN: So, if you just put a group, say, explain \--

DR. LAYTON: Through the top of the second page. Through the bullet.

MS. TUCKER FOREMAN: I\'m sorry, yes, through the bullet.

MR. DEMORGAN: Okay.

MS. TUCKER FOREMAN: Up to the point where it says AC21 members share a
vision.

MR. DEMORGAN: Okay. So, all of that would replace that. So, if you could
just, for everyone\'s sake, explain what the essence of your changes are
and then I think the challenge here is to then suggest to the group what
edits \-- and if there\'s \-- I mean, basically you\'re just saying a
quid pro quo switch out and I think that is going to present some
challenges given how we went yesterday, but, the group can discuss that
once you\'ve given them the overview.

DR. LAYTON: I read the first paragraph, the introductory, and, so, the
question is some of your editorials. So, are they \-- if you can, kind
of highlight which are substantive and which are just editorial.

MS. TUCKER FOREMAN: I think \-- I think the first paragraph there before
the first bullet is editorial.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: It does have one substantive change which is that
all the way through this, instead of referring to the agricultural
marketplace, I\'ve referred to the food and agricultural marketplace
because much of this does hinge on consumer public acceptance.

The first bullet had consumers have become more aware of the food they
eat, expect to be provided more information. You know, you can challenge
whether or not consumers have become more aware. What\'s happened is
that we now have continuous non-stop table news coverage which is a, you
know, a yawning maw that has to be filled and they fill it through
food-related discussions. There are food channels. There are endless
numbers of shows.

MR. DEMORGAN: I\'m sorry. Greg, Michael, what are you guys \--

DR. LAYTON: So, substantively, \--

MS. TUCKER FOREMAN: I have tried to make the first substantively fuller
than the first bullet was on the other one, on the committee draft.

DR. LAYTON: Okay. After looking at it sort of, I think \-- let me
suggest what Alison\'s comment was. Instead of consumers have become
aware, she had some consumers have become more aware of the food they
eat. And then what I saw you added especially was adding like at the end
it has its production through the internet and cable. I see you\'ve
added that, cable television.

MS. TUCKER FOREMAN: No, what I\'ve done is turn it around and say cable
and the internet have exposed consumers more and then down at the bottom
it contributes to an increased awareness.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: Which I think is more accurate than consumers
generally.

DR. LAYTON: Okay. And that\'s what I was trying to lay out. So, it\'s
really a switch around of the order of the paragraph and the main
additions were?

MS. TUCKER FOREMAN: A little detail about what it is that has changed in
the last ten years about the information that the public gets.

MR. DEMORGAN: Greg, do you have a question?

DR. JAFFE: I have a process thing. I guess I \-- I guess I didn\'t
realize you were going to go on to continuing the introduction today.
I\'m not sure that\'s the most fruitful use of our time as a group and I
would propose that the introduction be done by a work group on
conference calls in the coming weeks and us move onto the topics.

This was a \-- this is a Chair\'s draft, but, even I was in the work
group that worked on the introduction and there was a big discrepancy in
that group whether we were at the stage even drafting text and we let
Michael and Pat go ahead and do that. But, this is \-- we spent a lot of
time yesterday on this and I think based on the discussion we had about
this kind of stuff on the work group call, plus Carol\'s edit, and what
other people have, this is a very sensitive part of the introduction.

I think we\'re going to spend more than just, you know, ten on this. You
know, we\'ll probably spend the whole morning on it and I think if our
goal is in the end to get something done in the January time meeting
then I think it would be valuable to put this off, have a work group
work on this, and at least spend time of some part of today, and I
don\'t believe we can get through even if we start at 10:15 on the
topics get through all of those today.

That\'s just my \-- I didn\'t \-- I\'m sorry I came in a minute too
late. I don\'t know if there was a discussion about how we were going to
proceed.

MR. DEMORGAN: I think the presumption from the facilitation and the
Chair\'s perspective was that, yes, people did want to finish the
introduction this morning, but, you know, obviously folks can suggest
some different changes to the agenda.

Carol?

MS. TUCKER FOREMAN: Actually, I will support Greg because I think that
the introduction, even though we did lots of detailed revision to it
yesterday, is still very much in the nature of a preliminary draft and
it seems to me that a work group would be a good way to handle these,
especially this part, which is sensitive to people, and I do think that
although we made a lot of progress yesterday the only reason I went home
and wrote this was that when I read over what I had at least it didn\'t
\-- you know \-- it still needs a lot of work.

I was trying to short-circuit that work. I think it would be a good idea
to have this, what we\'ve done so far, plus these last three paragraphs
go to a work group for discussion.

MS. SULTON: How does the rest of the committee feel about this? Duane?

MR. GRANT: I would suggest \-- I would support taking this paragraph 10,
and which is page 6 and 7, to a work group, pages 7 and 8. I\'m not at
all excited about taking pages 1 through 5 back to a work group. I think
we had a work group of the entire committee yesterday and it would be
extremely wasteful of our time to take everything that we\'ve worked
through word-by-word yesterday and put that back to a work group. So, I
don\'t support that at all.

I do, you know, just looking at what we\'ve got ahead of us and 6, 7,
and 8 today, especially in light of the recent submission that Carol
brought to us this morning, I can\'t see where we\'d finish this
introduction and, frankly, probably we shouldn\'t finish it until we\'ve
done the issues anyway, especially on this section.

DR. LAYTON: Okay.

DR. SCHECHTMAN: I have one possible suggestion and that\'s just having
briefly looked at Carol\'s document and knowing that one place where the
committee had substantial discussion at the last meeting was around this
idea of a vision and there\'s this one paragraph on a vision where the
two are not identical but are similar enough that it might be useful to
aid the committee going forward if we had a discussion on that one
paragraph on the vision.

DR. JAFFE: Yeah, I would support that. I mean, I think that we had an
internal discussion in the work group about whether we wanted a vision,
what that vision would be. Having had plenary discussion about whether
we\'d get down to wordsmithing it or not we can see, but, these kinds of
discussions about the value of having that in the introduction and what
that should say I think would be valuable but I think the other
paragraph would be better for a work group.

DR. LAYTON: I\'m comfortable delaying this. I\'d like to have a little
bit of words about the vision even if we don\'t come up with a final
statement. I\'d like substantive changes. But, the other thing is, if
we\'re going to do this then I\'d like to send it out one more time
before January hopefully after we\'re working so that you guys look at
it, but, I\'d like to make sure that we all agree that if we\'ve got
substantive problems with it that we make sure we deal with those ahead
of time so that we can, you know, at least get it out and have an open
discussion about it.

And I\'m comfortable working with a work group, or, the attack on some
of these things based on all the substantive comments that we get.

Carol?

MS. TUCKER FOREMAN: When you go back to look at what we did yesterday it
does read like a document drafted by \--

DR. LAYTON: It\'s going to take some editing.

MS. TUCKER FOREMAN: \-- a committee and it\'s going to have to be \--
you know \-- I think we\'re in agreement about the substance, but, there
is \-- you know \--

DR. LAYTON: And I\'ll tackle it. And I don\'t have \-- and I don\'t mind
red lines either, so, I don\'t mind dealing with that, but, I just, you
know, but, I want to make sure that we\'re comfortable that, you know,
you\'re going to allow a work group to do that and you\'re going to feel
comfortable that when you do that we\'re going to really get perceptions
so they\'re not picky.

DR. DYKES: So the work group is going to work on Duane\'s suggestion?

MR. DEMORGAN: So, what I jotted down on the schedule, we\'re going to
discuss paragraphs 10, 11, and 13, assuming that we\'re going to have
some conversation on 12 right now, and I added as is appropriate because
there was that outstanding question of the milieu paragraph and linking
and where that actually fits in.

DR. LAYTON: And we had that other one paragraph that had to get fixed.

MR. DEMORGAN: So, what I was thinking was just based on you\'d share a
red line version with folks and there may be a need to kind of revisit a
couple of those things but not get into detail in all those paragraphs.
Bob?

DR. HERDT: Do I understand that you\'ll take this input and work
through, clean it so it reads to your satisfaction and so forth?

DR. LAYTON: Yes.

DR. HERDT: Without changing the meaning and then they\'ll be a work
group.

DR. LAYTON: Well I think that might \--

DR. HERDT: And then there will be a clone.

DR. LAYTON: I think it will be \--

DR. HERDT: And that avoids us picking around words and tenses and that
kind of thing.

DR. LAYTON: Yeah, I think that would help. Especially get the first of
it so that it reads kind of smoothly and flows.

DR. HERDT: Yeah, yeah. It was a committee so somebody go through, at
least clean that. So, clean it.

MR. DEMORGAN: What you\'re saying, Bob and Pat, is that Pat is going to
take the lead in developing a new draft of the introduction that
incorporates the edits that you made. Now, do you want that a red line
version? You want to see those changes?

MS. TUCKER FOREMAN: It would be helpful, I think, if we had a red line
version and then one that just accepted all the changes we made
yesterday because it\'s hard to read percents (sic), something that we
edited in that instance.

MR. DEMORGAN: What I find works is that you share the red line version
if anybody wants to use it, but, you use the clean version. You can
compare words yourself.

DR. SCHECHTMAN: We\'ll be happy to send out both versions and those who
don\'t want the red line version. If you don\'t know where it is I can
show you.

DR. CRAMER: But, I also think that from a logistic point of view we
ought to add new collections of text in the un-red lined one or you\'re
going to end up with \--

DR. SCHECHTMAN: Yes.

DR. CRAMER: \-- a billion different colors.

DR. SCHECHTMAN: Yes, yes, we will do that.

DR. CRAMER: And something that\'s completely incomprehensible.

DR. LAYTON: A document that doesn\'t have any red line on it, new text,
of all changes and I\'ll try to make sure all the verb tenses are
correct and it flows well and then we\'ll start from there for the work
group is what I heard. But, everything that\'s done, most of which we
won\'t go back and touch because we\'ve done all the substantive things
in paragraphs 1 through 9, except there were a couple of paragraphs that
had the milieu thing and then the one that Randy had problems on that
was the ref file or whatever it was.

So, we\'ve got to fix those and then we\'ll go from there with a work
group. And if anybody\'s got heartburn on the other paragraphs let me
know.

DR. SCHECHTMAN: Greg?

DR. JAFFE: I mean, I was just going to say, I mean, the draft that was
submitted was a Chair\'s draft that nobody in the committee had seen
before.

DR. LAYTON: Right, absolutely.

DR. JAFFE: And people on the introduction hadn\'t seen it, the
introduction committee hadn\'t seen it. There was nothing in the
consensus about whether or not we should even do a draft for this
meeting.

DR. LAYTON: Right.

DR. JAFFE: Based on the outline we had. We did a lot of editing
yesterday and a lot of stuff. I reserve my right at least to review that
and make additional, substantive changes.

DR. LAYTON: Nobody\'s saying no, Greg. Absolutely.

DR. JAFFE: And I want the committee to go ahead and put it on its
agenda, but, I also don\'t want people to misunderstand that I think
that\'s still a draft and at this point there\'s substantive changes,
not just editorial changes.

DR. SCHECHTMAN: The whole document\'s going to go back out for comments
and changes.

DR. LAYTON: And for, again, coming to the committee.

DR. SCHECHTMAN: Coming to the committee again.

DR. LAYTON: Absolutely.

DR. SCHECHTMAN: There was no expectation of any other greater status at
this point.

MR. DEMORGAN: My understanding of what Duane was saying was from the
work group perspective focus your efforts on 10, 11, and 13; get the \--
and it won\'t be the next, but, the version that comes out of that then
this group is going to have to have another conversation and you\'re
going to do that by sharing it ahead of time. You\'re going to get your
comments in in advance of that next meeting and people are going to
review all those things. Okay?

DR. LAYTON: Okay. Yes, Josephine?

DR. HUNT: I just want to do a checking of the final document was going
to be ready at the end of the January meeting. That\'s how it goes?

DR. SCHECHTMAN: Yes.

MR. DEMORGAN: That\'s what we asked for.

DR. HUNT: That\'s our deadline?

MR. DEMORGAN: Yes.

DR. DYKES: Just so everybody\'s clear. Deadlines have slipped so \--

DR. SCHECHTMAN: And I think it\'s worth pointing out the history on the
previous document where there was a general agreement that the document
was basically okay but people were given the opportunity to make \-- you
know \-- if they find little things that they couldn\'t \-- you know \--
the little things that they couldn\'t live with sounds a little bit like
an oxymoron, but, there was an opportunity for a final check, check mark
to be put via conference call.

DR. LAYTON: Yes. We did have an opportunity and we did the document and
at that last meeting we sent it out. We said if you\'ve got a
substantive issue we\'ll have a conference call. If there are no
substantive issues we\'re going forward. And, so, we had a process that
took about a month and a half to get it out once we had finished at the
last meeting.

So, it wasn\'t a \-- I mean, we didn\'t have a paper final copy.

DR. SCHECHTMAN: There was sort of a general agreement in principle that
the document could go forward subject to final corrections and that
could very well happen.

DR. LAYTON: Right, but, it gets it out and allowed everybody who was
going off the table to feel that they had completed the document and
were signatures to it.

DR. SCHECHTMAN: Yeah, and that was because people were going off of the
committee and we wanted to make sure that \--

DR. LAYTON: And we\'re facing that same issue again because we have
potentially four people going off the committee and, frankly, the
Secretary\'s asked us to finish it by the end of year. We\'re slipping
it to January. It\'ll be February before we give it to him probably.

MR. DEMORGAN: Okay. So, we said \--

DR. SCHECHTMAN: There are potentially \--

DR. LAYTON: Four? Four?

DR. SCHECHTMAN: Nine.

DR. LAYTON: Nine. Sorry.

DR. SCHECHTMAN: But, you know, exactly \--

DR. LAYTON: It was four last time.

DR. SCHECHTMAN: Yeah, but, at that point we knew four were not
re-upping. We don\'t have any information yet from you all about those
whose terms expire, whether you plan to reapply for membership on the
committee. We\'ll come back to that later.

DR. LAYTON: Okay. Let\'s take sort of 15 minutes or so and do this one
paragraph or big substantive changes or issues.

DR. SCHECHTMAN: Or thoughts \--

DR. LAYTON: Thoughts.

DR. SCHECHTMAN: \-- about the idea of vision. Yes?

DR. DYKES: Just for my thought process. Is there a work authority
established on the introduction?

DR. LAYTON: There was, but, it\'ll be at the conference call, but, it
was for an open conference call and I\'m sure everybody will be
notified.

DR. SCHECHTMAN: These are open-ended work groups. We identified some
people for the purpose of ensuring that there would at least be a core,
a balanced representational core, but, everyone is welcome to join the
conference call.

DR. DYKES: So, you\'ll send out a notice notifying us on the call and so
forth?

DR. LAYTON: Absolutely.

MR. DEMORGAN: Okay. So, we\'ve got three steps. Develop and revise the
intro. Pat\'s going to do that after these conversations. Schedule a
work group call to focus on paragraph 13 but also a couple of sundry
issues that are out there and then, third, show a draft review and
comments to full AC21 and comments in prior to January and you all can
figure out the schedule, you know, as we go.

So, then we\'re going to issue 12 which is on page 7. It\'s the middle
of the three boxes. So, we\'ll put that one up. It\'s up on the screen.
So, comments, questions about this? Carol, we know you have some
comments. You need to put them \-- the first being that food and
agricultural is one suggestion.

DR. LAYTON: Well, Alison has comments also.

MS. TUCKER FOREMAN: What I tried to do was shorten the sentences and I
was trying to get all of the same thoughts that were in the document, in
the paragraph that\'s there.

DR. LAYTON: Okay. So, really in the paragraph that\'s there, are the
thoughts all there? Are we in agreement with the thoughts? I can
certainly help shorten sentences.

MS. TUCKER FOREMAN: That was my goal.

DR. LAYTON: Okay. Are the ones that are already in the existing document
all there or did you make any substantive changes?

DR. HERDT: Could I?

DR. LAYTON: Yes.

DR. HERDT: Okay. While we were talking I read both, all right. So, let
me just \-- the first six or seven words in our version on the screen
are unchanged up until sensitive to and able to meet. Reading the second
line. Agricultural marketplace sensitive and able to meet. Carol has
substituted that can meet. All right. Now, is that a substantive change
or is that an editing change? I think it\'s an editing except the word
sensitive. You\'ve got to have sensitive. You can object.

Then the needs and preferences of customers and consumers appear in both
in the same order. In the United States and the world is in the original
draft and Carol has around the world.

DR. CRAMER: I prefer with the United States in there because I think it
has two different senses.

MS. TUCKER FOREMAN: I don\'t understand what the other sense is. It\'s
not a big deal to me, but, the United States is in the world.

DR. CRAMER: Yeah, but, this is going to our Secretary and the issues are
actually different than these two areas and the sensitivities are
different in these two areas so I like the way it reads better having
the United States in there.

MR. DEMORGAN: Any questions about that? Is that okay? Carol seems to be
okay. All right.

DR. HERDT: Can I continue? Reading on. Our text, original text says
transgenic derived and non-transgenic derived products. And Carol says a
variety of products including those derived from modern biotechnology.

MR. DEMORGAN: I see people\'s heads shaking.

DR. LAYTON: That actually sounds better. And then there is a period
which I think is a wonderful addition. Then going on in the usual text,
supported by. There\'s achieving the goal would depend upon regulatory
systems instead of supported by a strong regulatory system. But,
Carol\'s suggesting a new sentence beginning with achieving the goal
will depend upon.

DR. DYKES: I like Alison\'s.

DR. HERDT: Which was?

DR. SCHECHTMAN: On the right.

DR. LAYTON: Can we start a sentence though instead of Alison has it
still as the same sentence, we kind of all agree that the second
sentence would be good.

DR. HERDT: No, we\'re not \-- I don\'t think we\'re to Alison\'s
sentence yet.

DR. LAYTON: We are on the sentence.

DR. HERDT: I\'m on the line before that. Supported by a strong
regulatory system.

DR. DYKES: That\'s what Alison said.

DR. LAYTON: Okay. Is it this vision is supported by a strong national
\--

DR. VAN EENENNAAM: Achieving this goal will require us \-- will require.

DR. LAYTON: But, we don\'t have a goal. I\'m sorry. Achieving the
vision. Achieving this vision, okay? See what I\'m saying?

GROUP IN UNISON: Uh-hmm.

DR. HERDT: Will require a strong regulatory system.

MS. TUCKER FOREMAN: But there\'s not one national or international
regulatory system so it has to be plural.

MR. GRANT: I would like to suggest an edit in front of regulatory
systems used in front of the word science-based. I don\'t think that\'s
wise.

(Discussion off the record)

MR. DEMORGAN: We\'ve got the first sentence now with a period at the
end. Including those derived from modern biotechnology period. Now, the
next sentence is now changed to begin with something along the lines of
what Alison was suggesting?

DR. LAYTON: Achieving this vision \--

DR. SCHECHTMAN: Will depend on.

DR. LAYTON: \-- will depend on or will require?

MS. TUCKER FOREMAN: I think require is a better word.

DR. LAYTON: Will require. And you like the strong national and
international regulatory systems that ensure \--

MR. DEMORGAN: Strong national and international regulatory systems.

DR. LAYTON: That ensure.

DR. DYKES: I think food, feed, and environmental safety.

DR. LAYTON: Food, feed, and environmental safety.

DR. JAFFE: I would go back to Carol\'s line which is human and
environmental safety. There\'s worker safety. There\'s other kinds of
things other than just food, feed, and environment the regulatory system
addresses. Worker\'s safety in particular. And, so, \--

DR. LAYTON: Yeah, but, that\'s not an issue for this committee. We\'re
not talking about worker safety.

DR. JAFFE: We\'re talking here generally a statement about \-- and
that\'s not true at all. The regulatory system does ensure that the
workers who are working pesticides or putting on other things in the
farm have safety.

DR. SCHECHTMAN: Is everyone okay using environmental safety?

DR. LAYTON: Well, I don\'t think that addresses animals.

MR. DEMORGAN: To ensure human \--

DR. HERDT: To ensure human, animal, and environment.

DR. LAYTON: Environmental plants? I mean, you know, I don\'t know the
answer.

MS. TUCKER FOREMAN: It says here on the fact it\'s not just food and
feed, it\'s what we eat, but, you know, it\'s the focus of this I think
is having a system that serves the people who put governments in power.
And I keep being troubled by it kind of getting into this food and feed
which seems to be removed from people.

MR. DEMORGAN: Well, let me just ask you all to, first of all, to take a
step back and remember at least one of my ground rules is usually you
just pick one at a time so that a couple of times people are talking
over each other and that\'s not going to help moving forward. So, I\'d
just ask you to slow down, start using your cards again if you need to,
that\'s fine, or, just respect each other in terms of letting people
finish what they\'re going to say. One point.

Second point. I would say look at your vision because that\'s what
you\'re talking about. What does your vision say? Because this next
sentence says achieving this vision. Well, what do you need to do to
achieve that vision? Just put it in that context as opposed to a
discrete sentence by itself.

So, your vision is a diversified food and agricultural marketplace that
can meet the needs and preferences of customers and consumers in the
U.S. and the world for a variety of products including those derived
from modern biotechnology. Okay. Everybody agreed that that\'s a vision
that you share, right? So, then achieving this vision will require
strong national and international regulatory systems that ensure what?
So, somebody put a proposal on the table and we talked about that.

Duane?

MR. GRANT: I responded before the proposal that Greg put out. I mean, I
don\'t object to the term human. In my mind it actually weakens the
sentence somewhat. We\'re talking about food safety and human safety. I
mean, that\'s a much, much broader context. I grant you that the
regulatory system does provide for worker\'s safety but it\'s a
peripheral benefit almost.

What consumers care about, and I think the message that we want to put
out is, that we\'re concerned about food safety and, so, I guess I would
prefer that we use the word food in reference to things that people eat.

MR. DEMORGAN: Okay. So your proposal would be that it say what, that it
should be food?

MR. GRANT: Food, feed, and environmental safety.

MR. DEMORGAN: Okay. So type that in. I\'m not saying that\'s the final.
Just that\'s what Duane suggested. Now, Greg, you want to get back to
that?

DR. JAFFE: Well, I had your comment on what we\'re doing here and the
breaking up of the sentences, the way they point to me, which relates to
this and that is my vision includes safety in it and the original
sentence had that safety in it. The second one says the regulatory
systems is achieving that vision. So, actually, I mean, I prefer human
rather than food in the second sentence.

But, I think I need to \-- for the vision I think we should include AC
members share a vision of a safe and diversified food and agricultural
marketplace because to me that is my \-- when I think about it it\'s not
just go buy the food in the agricultural marketplace but it has to be a
safe one. When it\'s been broken up and says achieving this vision
suggested safety is somehow \-- that it\'s an unnecessary part of
getting that.

MR. DEMORGAN: Let me just check. Is there anybody who would disagree or
want to question whether or not you add safety on there? Daryl?

DR. BUSS: Well, grammatically, it modifies marketplace. It makes little
sense to me.

DR. DYKES: Say marketplace.

DR. JAFFE: Well I\'m not sure what it does, but, the way you\'re
proposing it.

MS. TUCKER FOREMAN: Well if you put it before safe.

MR. DEMORGAN: Daryl, is that what you\'re suggesting?

DR. BUSS: My point is, as it now reads it modifies marketplace.

DR. SCHECHTMAN: I think in part that was why it was all in one sentence
before so that that safety was supporting that marketplace. I think \--

MR. DEMORGAN: So, how\'s that, safe food supply and diversified food and
agricultural marketplace? Does that get your point? No, people don\'t
want that.

DR. JAFFE: That\'s my point.

MR. DEMORGAN: Right. I\'m just \--

DR. JAFFE: It does get my point.

MR. DEMORGAN: The question is, does anybody disagree with the idea of
integrating, say, the concept of safety into the vision? Michael?

DR. DYKES: I think to Michael Schechtman\'s point. That was what when we
had the comma and that\'s what was finally done by the tail end of that
sentence is to tie that to it.

MR. DEMORGAN: So, it\'s okay if we\'re splitting it to include safety
somehow in there in the vision?

DR. DYKES: Yeah, I\'m okay with putting in safety. That\'s fine.

MR. DEMORGAN: So rather than wordsmith it at this point right now about
how it fits, just put a little placeholder saying \--

DR. LAYTON: Safety needs to go in the first vision statement.

MR. DEMORGAN: Right.

MR. OLSON: I\'d like to \-- I\'m sorry \-- I\'m just saying this survey
we do about food safety is by far the number one item that\'s always
listed all the time. It is ahead of diversification. It\'s ahead of
everything. Food safety is very, very important.

MR. GRANT: The only comment I would make is if we\'re not going to
wordsmith it now is that whoever does the wordsmithing needs to be
careful not to imply by the place that they put the word safe that the
food supply is not safe currently.

DR. LAYTON: Got it.

MR. DEMORGAN: Okay. Carol?

MS. TUCKER FOREMAN: Oh, I absolutely agree with that, but, just saying
that it is a vision to have a safe food supply as this did up there a
minute ago I don\'t believe suggested the current food supply is not
safe and if that is a problem for people just saying that makes people
think we\'re suggesting it\'s not safe then we ought to have that
discussion in the plenary because that\'s a big problem.

MR. DEMORGAN: Ron?

MR. OLSON: Actually, it\'s usually you use the term vision to suggestion
something moving toward away from where you are now. So, in fact, that
does \--

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

MR. OLSON: \-- imply that the current system is not safe.

MS. TUCKER FOREMAN: I would also suggest that there\'s some evidence
that it\'s not entirely safe. There\'s 76 million cases of food-borne
illnesses every year and 5,000 deaths.

MR. DEMORGAN: Okay. Okay. Okay. Ron?

MR. OLSON: Just add the words it\'s a vision of preserving a safe system
or something like that where you \--

DR. LAYTON: Okay. We can work on that one. Let me go back. If we put
safety in the first issue do I have to have safety in the next part
about achieving the vision of the regulatory systems and do I have to
have safe again there? That\'s a question.

If we move it under the first sentence and get the concept of food
safety in there can we then just say \-- can we just describe in the
regulatory system without talking about what it\'s going to ensure? You
know, can I just say it\'ll be supported by a strong international and
national regulatory system and by evolving and strengthening regulatory
mechanism in other countries? I\'m just asking.

MR. DEMORGAN: Carol? I think it\'s on this sentence, right?

MS. TUCKER FOREMAN: Yeah.

MR. DEMORGAN: This question.

MS. TUCKER FOREMAN: I \-- I \-- I think if you can adjust it to say but
what does a strong regulatory system do? Is that assumed from having
safety? It could just

be \--

DR. LAYTON: That\'s my question. Do I need to list out environment and
food or human and environment? That was the next question.

MS. TUCKER FOREMAN: I think that it has to be there because otherwise it
might be taken as just a regulatory system that assures diversity.

DR. LAYTON: Okay.

DR. MELLON: I agree.

DR. LAYTON: Okay. That\'s all I wanted to know.

MR. DEMORGAN: Alison?

DR. VAN EENENNAAM: Yeah. I just \-- because when I put national and
international in there that kind of removes the evolving science part of
it from the center.

DR. JAFFE: Yeah, that second part.

DR. LAYTON: Okay. We all vote for that change. Okay. So, got it.

MR. DEMORGAN: So, we\'re going to strike that sentence or that part of
it. Any questions? Okay. Michael?

DR. DYKES: I agree with that, striking that last part, what Alison said.
Also, I would suggest we remove the word strong. I\'m kind of where
Carol is. I don\'t know what a strong regulatory system means. I think
national and international regulatory systems, to me that\'s rendering
decisions on food, feed, and environmental safety. I just don\'t think
the word strong is an appropriate modifier for a regulatory system. Does
it mean it wants to keep on, is that a strong one?

DR. LAYTON: Okay.

MR. DEMORGAN: Okay. Are these \-- is your comment in response to that?

MS. TUCKER FOREMAN: Only in part because I wanted to go back to the
human versus food and feed issue.

MR. DEMORGAN: So we\'re to take strong out. Alison is your\'s up for
that?

DR. VAN EENENNAAM: Not for the strong.

MR. DEMORGAN: Okay. So, Carol and then Alison.

MS. TUCKER FOREMAN: The \-- in the community that I operate in there is
a difference between food safety and human safety. One suggests that we
build something that meets \-- that the industry can achieve for a given
price and the price and the burden of regulation is part of the
equation. The same human safety puts whether or not humans are the focus
of the system and the food system therefore has to produce something
that meets a human food safety standard.

We\'ve run into this problem in microbiological issues all the time. You
have to prove it\'s safe for humans and you have to have something that
scientists suggest is a reasonable level of purity to be expected of the
industry. So, I see from the expressions that I\'m not making this
entirely clear. But, for us the goal of the system when it\'s food that
people are going to eat is that it be safe for human beings.

MR. DEMORGAN: So you would like it to say human

\-- you\'d be okay with overseeing animal and environmental safety?

MS. TUCKER FOREMAN: Yeah.

MR. DEMORGAN: Okay. So, we\'ve got the other option \-- maybe you can
just type this in in brackets \-- is food, feed, and environment.
That\'s what we\'re currently debating. Alison?

DR. VAN EENENNAAM: How about just safety? That\'s how it was originally.
This is all being modified and you can draw your own \--

MR. DEMORGAN: Other comments on this? Michael?

DR. DYKES: Yeah. I guess I\'m a little confused as to what Carol is
trying to articulate and I\'m trying to understand you, Carol. I guess
what \-- and what I think I hear you talking about is the whole concept
around risk assessments and, so, I don\'t want to put words in your
mouth. Are you saying you want it so that it\'s safe with zero risk
versus an acceptable level of risk is assumed?

Because I didn\'t get the distinction that you were trying to \--

MS. TUCKER FOREMAN: No, no, I\'m not saying zero. I\'m saying I want the
focus to be what is safe for humans to consume, not what is reasonable
to expect that the industry can produce.

DR. LAYTON: Yeah, but, that means we can never grow peanuts again.

DR. CRAMER: So, that means we should hold Twinkies.

MR. DEMORGAN: So let me get Mardi in here.

MS. TUCKER FOREMAN: You know, the truth is I tried to take them out of
the school lunch system thirty years ago and it hasn\'t been a good
thing.

MR. DEMORGAN: Mardi?

DR. MELLON: I mean, I would be in favor of including what we wrote, the
regulatory systems to ensure. I think ensure safety is just way too
broad. I mean, to me it isn\'t even broad enough. I\'d like to see a
system that looked more broadly just at safety issues, that look at
socio-economic consequences, but, we\'re not going there. But, if we\'re
not going there at least I want to know where we are going and, so, I
think including the three components is important.

MR. DEMORGAN: I\'ve got human, animal, food, feed, and environment.
Carol?

DR. CRAMER: I had actually put \-- we\'re putting safety first, ensure
safety of the food and feed supply which is basically what Carol is
saying. I mean, the safety of the food supply is the issue we\'re
looking to regulate. But, then I said, food and feed supply and the
environment. Do we ensure safety of the environment?

DR. MELLON: No, we really don\'t. I agree with you. But, it is an
elocution that is about as good as one can get, but, you\'re going to
look at environmental issues.

DR. CRAMER: Especially in hurricane season, you know.

DR. SCHECHTMAN: Can I ask how people might feel about a very, very
inelegant solution to this which might be to say to ensure human and
animal (food and feed) safety and environmental safety.

DR. CRAMER: I think she just said that.

DR. SCHECHTMAN: Did you say that?

DR. LAYTON: No, it\'s up on the wall.

DR. CRAMER: Ensure safety of the food and feed supply.

MS. TUCKER FOREMAN: How about ensure that the \--

MR. DEMORGAN: Just real quickly, what Carol did was not add humans and
Michael was trying to integrate that in so it was a little different.

DR. CRAMER: But, also since my card is still up. And we\'re not ensuring
animal safety. That\'s not even what we\'re trying to say. We\'re
ensuring safety of the food and feed supply. And we can\'t ensure safety
of the environment. You know, what is this? So, what we\'re really
saying is that we want this regulatory system to ensure safety of the
food and feed supply and not to mess up the environment in the farm
step. So, if we say the safety of the food supply have we not captured
the concept of human health?

MR. DEMORGAN: Okay. Carol and Greg.

MS. TUCKER FOREMAN: Pass me because I\'m still trying to work something
here.

MR. DEMORGAN: Greg?

DR. JAFFE: I just think the system does ensure animal safety. I mean,
the new animal drug provisions toughly deal with animal welfare and
efficacy of drugs and transgenic animals are being treated as drugs and
so it does. I mean, there is a lot of animal safety in the regulatory
system that APHIS and FDA both address so it\'s not just whether the
food that the animal is eating is safe for the animal, but, there
actually is a lot of other instances where the animal safety is
considered, maybe not in an absolute sense, we\'re not guaranteeing the
animal safety nor are we guaranteeing the environment safety.

But, clearly, the goal of the regulatory system is to minimize the
impacts on the environment, the result being a safer environment and
clearly the goal is to balance the risks and benefits to the animals and
attempt to ensure their safety or relative safety compared to other
systems.

MR. DEMORGAN: Pat?

DR. LAYTON: I think the issue that I sort of hear is this concept of we
can\'t ensure or ensure against hurricanes, tornados, things like that.
If you lay it out there in a broad vision it\'s that. So, what I think I
hear is it\'s to ensure human and animal safety in the food and feed
supply and production systems.

It\'s the end supply of food and feed and you\'re also, Carol, I think
you\'re worried \-- you\'re talking about the production system itself
so that humans and animals are okay during the production of that food.
So, I don\'t know if that solves or just irritates the system \--
irritates the complication, but, it\'s not that we\'re trying to have
this regulatory system do the world of safety, it\'s really the
production system of that and then how it\'s used in the food and feed
system.

And that would include the animals for production of pharmaceuticals and
things like that. So, I don\'t know if that\'s a help or not. I just
thought that.

MR. DEMORGAN: So, did you offer a specific suggestion?

DR. LAYTON: I think it was that ensures supply and its production
system. Something like that.

MR. DEMORGAN: But, it would start with the human and animal safety
point, right, the way you said it?

DR. LAYTON: Yeah, and I think if you do that then the environment might
be included under production system but I\'m not sure about the word
environment. Again, I don\'t know that we can ensure environmental
safety. That\'s \--

MR. DEMORGAN: Okay. Carol?

MS. TUCKER FOREMAN: I have a proposal, please. Would ensure that the
food and feed supply is safe for humans and animals and the environment
is protected.

DR. CRAMER: It\'s okay with me.

DR. LAYTON: Okay. I could live with that.

DR. CRAMER: Good job, Carol.

MS. TUCKER FOREMAN: It\'s building off of what you were proposing.

MR. DEMORGAN: So, could you read that one more time?

MS. TUCKER FOREMAN: Yeah, I actually wrote it down. To ensure that the
food and feed supply is safe for humans and animals and the environment
is protected.

MR. DEMORGAN: Ensure that the food and feed supply is safe for humans
and animals and that the environment is protected.

MS. TUCKER FOREMAN: Yeah.

(Discussion off the record)

MR. DEMORGAN: Anybody unable to live with that statement? Okay. Alison?

DR. VAN EENENNAAM: I\'m not sure you can ensure food safety. That word
is very strong.

DR. LAYTON: Ensure is a bad word for you?

DR. VAN EENENNAAM: Nobody can ensure food safety. You can consider it,
or, check it, or, something, but, you can\'t ensure it.

MS. TUCKER FOREMAN: But, the government thinks that it\'s doing that
now.

DR. JAFFE: And that\'s what the laws talk about.

DR. DYKES: You could say our goal is to ensure.

MS. TUCKER FOREMAN: It\'s our vision. We\'re talking about a vision. A
vision is to ensure.

MR. DEMORGAN: I guess, Alison, what I suggest is, I mean, you raised an
interesting point and something for folks to think about. In terms of
today though, if we can live with it now, recognize that the whole
document comes back, so people should look at this vision just like you
look at the rest of the document \-- the rest of the introduction at
some point in the future in its full context.

MR. SLOCUM: Paul, since food is internationally traded are we presuming
that these national and international regulatory systems are compatible
or consistent with one another? We talk about that in a lot of places in
these documents.

MS. TUCKER FOREMAN: Does it have to be in the vision statement?

DR. LAYTON: I think that\'s what\'s going to lead up to an issue. I
mean, we have a vision and then we have an issue that\'s going to talk
about it. I think there\'s an issue that covers some of that.

MR. SLOCUM: It\'s in just about every time we talk about regulations it
seems.

DR. LAYTON: Okay.

MR. DEMORGAN: So ready to move on almost? Greg?

DR. JAFFE: Well, that comment just made me re-look at the words there. I
mean, there aren\'t really international regulatory systems. I mean,
there are national regulatory systems and there are international in
different countries, but, I mean, Codex and things like that aren\'t not
regulatory systems. They\'re guidelines and other kinds of things and
even the Protocol is implemented through national programs.

So, I understand what Alison was trying to get at and I agreed with that
because I hated the evolving systems in other countries frankly, but,
\--

DR. LAYTON: Okay. So strong national systems \--

DR. JAFFE: \-- if you read, literally international regulatory system
might be something \-- I\'m not sure we are \-- that is necessarily all
of our visions that we, at least, are regulated by some international
body as opposed to what we\'re trying to get at is different countries.

DR. LAYTON: It just says national regulatory systems. As long as it\'s
plural it\'s multiple systems.

MR. DEMORGAN: Okay. Mardi and then Carol.

DR. MELLON: I understand the point, but, I really think an efficient
system is better than in a vision statement that the notion of national
and international regulatory systems is \-- you know, is appropriate. We
then say we know this isn\'t going to be easy. The reason it isn\'t
going to be easy is that for all the reasons we\'re going to talk about.

But, I think we\'re \-- you know \-- that we\'re being too picky there
to worry about whether Codex is really a regulatory system rather than a
guideline.

MR. DEMORGAN: Okay. Carol?

MS. TUCKER FOREMAN: Yeah. I was actually going to go to another point so
if \--

MR. DEMORGAN: Okay. So, just \-- other \--

DR. HUNT: I just have one comment on that.

MR. DEMORGAN: Yeah.

DR. HUNT: How about \-- I\'ve forgotten who mentioned it, I think it was
you, Jerry, something like compatible domestic and foreign regulatory
systems as a vision?

MS. TUCKER FOREMAN: Depend upon compatible domestic and foreign?

DR. HUNT: Uh-hmm. Yeah, because I think if we just say national systems
it might be \-- it\'s not clear what you mean within different
countries.

MR. DEMORGAN: Duane?

MR. GRANT: I\'m going to agree with that.

MR. DEMORGAN: Greg?

DR. JAFFE: I mean, I\'ll be fine with domestic and foreign. I don\'t
like the compatible there. I mean, I know we want to have our system
whether it\'s compatible with other systems or not. We want to ensure
safety in the U.S. first and foremost and that\'s probably going to the
lowest common denominator with other countries and so compatible to me
suggests that we\'re giving up some of our domestic abilities.

MR. DEMORGAN: Okay. Josephine\'s waving and then we\'ll go to Michael.

DR. HUNT: What we\'re saying, it has to be safe so that has to be safe.
That is the common denominator. I\'m not saying we have to go to a lower
level. It has to safe.

MR. DEMORGAN: Greg?

DR. JAFFE: I don\'t know why we need the compatible and just say
domestic and \-- I don\'t see what compatible gets us other than
attempting to make ours the same as somebody else\'s or flopping us in
that they\'ll have to be the same regulatory systems. So, I mean, I
guess I understand what you\'re saying, but, I don\'t see we\'re
compatible as them.

DR. HUNT: I\'m thinking in terms of the vision if we\'re looking at
global trade. Having systems that are compatible is something that is
going to help global trade and biotechnology.

DR. LAYTON: If they\'re all like ours that works. If they\'re not \--

MR. DEMORGAN: Michael, do you have a comment on this point?

DR. DYKES: I\'m kind of with Greg. I hear you on the trade aspects. To
me, this is the regulatory system and I would not personally like the
word compatible. I don\'t know what it really means in this context
here.

DR. HUNT: Organized.

MR. DEMORGAN: Just so \-- I mean, Josephine was going to Jerry\'s point
about compatibility but I think you\'re hearing at least some folks
saying that in terms of achieving vision, making it domestic and foreign
regulatory systems, get \-- I mean, again, the focus of this sentence is
to ensure that food and feed supply is safe. So, that\'s what some folks
were saying, that we don\'t need \--

DR. DYKES: But, she also \-- the compatible, whether it\'s the right
word or not, also addresses my concern that if we didn\'t \-- if food
and feed didn\'t cross borders we wouldn\'t have this problem, but, the
fact that food and feed does cross borders there\'s a trade element here
that we can\'t avoid, that we don\'t talk about specifically in the
vision. When we talk about domestic and foreign regulatory systems we
can apply it.

So, we need to talk about there being some harmony between them. Maybe
compatibility\'s not the right word. But, there needs to be a sense of
co-existence so trade can happen because it\'s going to.

MR. DEMORGAN: Okay.

DR. DYKES: What\'s that word, harmonize?

MR. DEMORGAN: Okay. Duane?

MR. GRANT: If we take the word compatible out then I would come back to
the comment made a minute ago and that\'s to support Mardi\'s insertion
of the word international is broadly defined and has to capture what our
vision is here and that is that there would be regulatory systems in
countries that do ensure safety of its food, etc., etc. but that there
are also roles for international regulatory systems that are emerging,
Codex, etc., that in the next five to ten years likely will play a
larger role.

So, I think if we exclude the word international and leave only domestic
and foreign it seems to me to exclude those cooperative and
collaborative systems that we\'re trying to develop to \-- that will
lend compatibility in the regulatory system.

MR. DEMORGAN: Josephine?

DR. HUNT: No, sir.

MR. DEMORGAN: Okay. Greg?

DR. JAFFE: I\'m comfortable keeping that \-- I mean having the thing
national and international. I just wanted to raise the issue of the way
somebody could interpret it. I do think that trade is covered in the
first sentence where we say that can meet the needs and preferences of
consumers and customers in the United States and the world for a variety
of products. To me that\'s the whole vision is to \-- is not just the
domestic marketplace, but, it is an international marketplace and
meeting customers in the U.S. and the world.

So, I think that first sentence clearly brings in the trade aspect and
the international aspect. But, I\'m still uncomfortable with compatible
or harmonized being in there.

DR. DYKES: Well, are we comfortable then with an international
regulatory system that replaces national systems?

DR. JAFFE: I\'m comfortable with the language, national and
international regulatory systems.

DR. SCHECHTMAN: I thought what I heard a moment ago was the suggestion,
I think from Duane, that there be domestic, foreign, and international;
that all three be listed. That wasn\'t \--

MR. GRANT: That wasn\'t exactly my suggestion. I said national and
international.

DR. JAFFE: And I\'m comfortable with that.

MR. DEMORGAN: Is there anybody that \-- we\'ve got two kinds of related
issues obviously. Is there anybody that wants to argue to keep domestic
and foreign or is national and international regulatory systems
acceptable for the time being moving forward recognizing you\'re going
to have another chance to look at the whole document?

DR. LAYTON: Yes. The word system is plural to both national and to
international and I know there\'s not an international regulatory
system, but, \--

MR. DEMORGAN: Okay. So we\'re going to get rid of domestic and foreign,
go back to national and international, and then the outstanding question
then is, does the concept of compatibility in any way need to be
incorporated?

DR. LAYTON: Compatible.

DR. HUNT: Well, the idea was covering international systems is that
there would be compatibility was my understanding.

MR. DEMORGAN: So it\'s inherent.

DR. LAYTON: Yeah, but, take the word compatible out.

MR. DEMORGAN: Leave that in there for the time being and Jerry can think
through how to \--

MR. SLOCUM: My question is, not a question, so, is our vision
accomplished with international regulatory systems? Is that what we\'re
saying is going to take to accomplish our vision is that we have an
international regulatory system?

MS. TUCKER FOREMAN: National and international.

DR. CRAMER: National and international.

MR. SLOCUM: So, to accomplish your vision we must have in addition to
national, international regulatory systems?

MR. DEMORGAN: Broadly defined.

DR. CRAMER: Broadly defined.

MR. DEMORGAN: Okay. So, why don\'t you think about that off-line. You
know, I appreciate Greg\'s suggestion that we, you know, move out of the
introduction now quickly to save time.

MR. SLOCUM: But, I think it\'s important to understand what our vision
is.

MR. DEMORGAN: Absolutely. Absolutely. I think you all are getting a
better understanding.

MR. SLOCUM: That\'s why we\'re doing this, isn\'t it?

MR. DEMORGAN: Yeah, exactly.

MR. SLOCUM: So, it\'s our vision, part of our vision then that we have
international regulatory systems.

MR. DEMORGAN: Broadly defined.

MR. OLSON: I want to come back to the trade issue. USDA is very
concerned about trade and a lot of this stuff falls under other
organizations of the government, but, I don\'t know if we adequately are
picking up trade. But, if we didn\'t have regulatory systems in every
nation in the world we can\'t trade with each other. So, the fact that
they have a system that ensures food and feed safety and environmental
safety may be different enough from us, we can\'t trade with each other.

So, somehow we have to get something in there that implies, I think,
more strength around the trade issue that how do we work together; how
do we get to the sharing or this workable system or whatever the term
is.

MR. DEMORGAN: What I need now is a suggestion. I mean, because I think
you\'re right. Your first sentence, your vision says marketplace in
there and Carol\'s got a comment on this.

MS. TUCKER FOREMAN: Jerry, if we could say it we would probably say
domestic and foreign. I think people thought that kind of flanks this
language and national and international in my mind is where it should
be; read domestic and foreign rather than having actual international
systems that apply to everyone.

I\'m really reluctant to raise the issue of trade in the vision
statement. I think we have some strong differences about that and at
this point I think the diversified food and agricultural marketplace
that meets the needs of people around the world would include,
obviously, trade. If you\'re going to meet the needs of people around
the world you\'ve got to be trading.

MR. DEMORGAN: So, I think, you know, what \-- I mean, it says what
you\'re saying there, Carol, in the first sentence.

MS. TUCKER FOREMAN: Yeah.

MR. DEMORGAN: That\'s right. So, I mean, the question, I guess, and you
all can figure out whether you want to have this continuous conversation
now, achieving this vision will require regulatory systems. The question
is, is that the only thing that will be needed? Probably not. But, do
you want to list out in this statement everything, exactly what you\'re
talking about? And that\'s the question you have to look at.

I guess at some level, once you\'ve got the introduction and once
you\'ve got your issues flushed out, you can cycle back to it and figure
that out. That\'s one thought. But, it\'s up to you. So, do you have
anything specific, Ron, at this point to suggest?

MR. OLSON: I like the way to add it on rather than \-- add on and
support international trade as part of this because I still say we can
have a perfect regulatory system all around the world. We can\'t trade.
And part of it, we\'re already at the tail end of the dog on some
commodities, especially like wheat and stuff like that. The world may be
trading, but, we may not participate.

MR. DEMORGAN: Okay. So, if we have a work group, so, let me just \--

DR. JAFFE: I mean, I guess I\'m with Ron on the same language on trade
in the vision statement, but, not in that same sentence or clearly not
the way it\'s worded there because that suggests that the regulatory
system job is to support international trade and I don\'t think that is
the case.

That doesn\'t mean that the U.S. Government\'s job isn\'t to support
international trade or other things, but, the regulatory systems that
we\'re talking about here I don\'t think their job is to support
international trade and, so, I don\'t think \-- I don\'t think it should
be in that sentence because the sentence is already long enough, but, I
would be open to seeing some language in a third sentence there that
might also say something about importance of trade or something like
that.

But, I don\'t think the language as put in there or even just modified
is valuable.

MR. DEMORGAN: Okay. Josephine?

DR. HUNT: I mean I\'d just like to say this, and I think you brought it
up earlier, that this first sentence is our vision and the rest of that
paragraph is how we\'re going to achieve that and that we do mention
about international trade in the first sentence so I think it should
appear somewhere in the how to.

MR. DEMORGAN: Okay. So similar to Greg then. You\'d be willing to
entertain language, think that it\'s a good idea, may not be the best
place in that longer sentence.

DR. HUNT: Well, put a stop in there somewhere and start again.

MR. DEMORGAN: Mardi?

DR. MELLON: I support that. I think somewhere in there there ought to be
and I\'m also willing to go along with, you know, only having it in a
separate sentence, but, I think it \-- you know \-- it is in the
interest of the U.S. and all of our farmers to have a system that works.

So, understanding that in some way, the priority for trade has not
served some other interests that I care about. I don\'t want to go all
the way to the other end and say that somehow having a functional trade
system isn\'t important because I think that it is.

MR. DEMORGAN: Okay. So, given that nobody\'s proposed specific language
we\'ve got it as a placeholder at the end and it\'s a new sentence and
it\'s in brackets, like that safety issue, the first one. So, that\'s
where we\'re going to leave it for the time being unless someone\'s got
a specific suggestion about it, recognizing the work group can talk
about it and you all will have a chance to look through it again.

MS. TUCKER FOREMAN: I realize it\'s not as important to international
trade, but, I think the regulatory system has to do something beside
assure safety. It has to inspire public trust in the process by which we
got there. Acceptance of these products is probably \-- it impinges on
confidence and integrity of the system as it does in anything else. We
all know that in Great Britain, throughout the EU, the problem with
rejection of biotech products has been \-- has grown out of their lack
of confidence in their own regulatory systems and the lack of trust.

So, I had to put in mine inspire public trust in the decision-making
process. The sentence may have gotten too long now to do that.

MR. DEMORGAN: It would be down in the second sentence, right?

MS. TUCKER FOREMAN: Yeah, keeping the vision will require national and
international regulatory systems that protect humans and animals and the
environment.

MR. DEMORGAN: You\'ve got all the language.

MS. TUCKER FOREMAN: Yeah, and inspire public trust in the
decision-making process.

MR. DEMORGAN: And inspire.

DR. CRAMER: I would just say inspire public trust probably.

MS. TUCKER FOREMAN: That\'s fine.

MR. DEMORGAN: So if you just added and inspire public trust does anybody
have a problem with that?

MS. TUCKER FOREMAN: We have systems as plural, isn\'t it?

DR. LAYTON: Uh-hmm.

MR. DEMORGAN: We\'re good, we\'re good. There was an editor out there
somewhere \--

DR. LAYTON: Thank you.

MR. DEMORGAN: \-- who can work through this. Okay. Okay. So, we\'re
going to leave this for now.

DR. SCHECHTMAN: There\'s one more sentence.

DR. JAFFE: There\'s one more sentence that Carol had that I thought was
a good, I think, editorial.

MR. DEMORGAN: Sure. So, on the all recognized sentence?

DR. JAFFE: Uh-hmm.

MR. DEMORGAN: Okay. What\'s the suggested edit?

MS. TUCKER FOREMAN: That while achieving the goal will not be easy it\'s
a worthwhile endeavor.

MR. DEMORGAN: We can type it up in a second. Is there any problems with
that editorial change?

DR. HERDT: Just to be consistent we should use vision rather than goal.

MR. DEMORGAN: Okay. Good. Good catch. Okay. So, there\'s two outstanding
issues here. I think what I would suggest is that given the construct of
steps that we\'ve asked all of you to agree to with Pat, work to develop
some language around safety as well as the sentence around the
international trade aspect and imbed that into the next version. And I
would just say, you know, make sure people understand that those are
yours, not the groups agree to, some like it, and bracket it maybe for
the small group, some task group, or others to talk about.

DR. LAYTON: And I would appreciate any helpful suggestions in those
middle-of-the-night brainstorms.

MR. GRANT: I just would like to put brackets around the word inspire. I
don\'t disagree with it. The concept, the word, I don\'t like. That\'s,
in my mind that\'s the wrong word for that place as far as the wrong
definition. I believe that the concept I fully support. I\'m just \--

MS. TUCKER FOREMAN: I thought visions were supposed to inspire.

MR. GRANT: Maybe they are.

MR. DEMORGAN: All this language has brackets around it at some level.
Bracket means you\'re asking Pat to rework it.

MS. TUCKER FOREMAN: Let me just make one suggestion. Since we\'ve used
ensure I think \-- did we use ensure or assure?

MR. DEMORGAN: Ensure, yes.

MS. TUCKER FOREMAN: Maybe we could assure public trust.

DR. MELLON: I like ensure.

MR. DEMORGAN: So, all I\'m saying is you raised it. Is engender okay?

UNIDENTIFIED MALE: Engendered is great, yeah.

MR. DEMORGAN: Okay. So we\'ll leave that for now and then, again, the
whole thing, you will have a chance whether you like it or not to do
this again. Michael?

DR. SCHECHTMAN: I just want to make a point that we\'re going to leave
this right now, but, I think that this little thing is actually a
considerable accomplishment because it really was not clear at the last
meeting that there was going to be something that looked like a common
vision statement.

Now, if you believe there\'s still a blank sentence in there and a few
missing words, but, I think it\'s quite useful.

DR. LAYTON: Actually, everybody should, you know, really pat themselves
on the back.

MR. DEMORGAN: Okay. All right. Thank you. So, like we said \--

DR. LAYTON: Could we just take a quick five break.

MR. DEMORGAN: Yeah. So, like we said, we\'ve got the next steps in terms
of this document. Basically we\'re going to move off of this for the
time being. And you\'ll see versions of that and you\'ll have
conversations set up. So, look at your watches and in seven minutes
we\'ll be getting started again.

DR. LAYTON: We\'ve got a lot to do today.

(Whereupon, a brief recess was taken)

MS. SULTON: Well, welcome back to part two. Okay. We are on the record
now. We\'re resuming to discuss the issues, the topics of discussion.
There are 27 of them. There are 28. The first nine are new and haven\'t
been discussed in any great detail by the full committee so we want to
make note of that fact and possibly delay the discussion of those topics
that were covered in the T&L report until the end.

The other thing that I think we want to keep in mind as we pursue this
discussion is that we want to continue as we did this morning to work
beyond our differences and I think we did a really great job on the
vision to do that. We\'ll focus on first the statement and make sure
that the statement is understandable and consistent with our vision and
what we want to say and then we will review the text that follows that
statement to make sure that it also is clear and does further explain in
a clear manner what this statement meant.

So, again, if we can\'t agree then we\'ll table the issues, these topics
that are discussed in the T&L report, and then just go on in order to
the topics, the 28 topics.

Yes, Greg?

DR. JAFFE: Can we just have sort of a discussion about what is our work
plan for the rest of the day? When you say table T&L things does that
mean we\'re going to come back to them later in the day, we\'re not
going to discuss them all today?

MS. SULTON: The T&L topics we won\'t get to.

DR. JAFFE: Well, I guess that\'s sort of what I would like to know. What
are sort of our goals? Are we going to micro-edit things like we\'ve
been doing here? Is our goal to try to get through all of them, but, at
a higher level to make sure we\'re on board with topics being in the
report? I\'m trying to get a feeling for what we\'re trying to
accomplish so I understand the level of detail we\'re going to deal with
being the ones that we\'re putting off, what\'s going to happen to those
and so forth.

MS. SULTON: We don\'t intend to edit this microscopically but rather
look at it at another level.

DR. JAFFE: So, not what we\'ve done yesterday with some of the
discussion. We\'re not going to do that today?

MS. SULTON: That was not out intent. Yes?

DR. LAYTON: At a mental level I have a question and then I\'m going to
beg your permission. When we left our last meeting you asked for
everything to be in three or four sentences in the issue discussions
underneath. Michael and I tried to do that, although it left us with
very long sentences that were somewhat complex.

Okay. I would like your permission to use a little more than three
sentences so that I can \-- so that we can edit it down so that it \--
you know \-- not too substantively unless you direct me to substantive
change, but, to basically utilize a few more sentences so that it\'s
easier to read and I could read it out loud without having to take a
breath.

DR. SCHECHTMAN: Not make them any longer.

DR. LAYTON: Right. No sentences that are longer and no issues that are
longer. It\'s just like, say, number 1, but, more sentences instead of
less sentences.

MS. SULTON: More elegant.

MS. TUCKER FOREMAN: Two points. One, if the \-- take these issues as two
or three people suggested in the comments, if we take the issues that
are covered in the trace and label, traceability and labeling document,
and just reference where they are in that document rather than having
the discussion written out here, and I urge us to do that, at least in
part, because dealing with it again here raises the possibility that we
say something inconsistent.

So, having said it, we ought to shut up now. Just reference those
documents. That will give us more time and space to discuss some of
these issues in more than two or three sentences and since I think that
there will be places where, unfortunately, we will \-- not unfortunate
\-- it educates the Secretary \-- but, we will have different views on
the committee. We can say, we have different views on the committee.

I don\'t view that as a problem. I think that it, in fact, would
demonstrate to the Secretary that these are, as he already knows, these
are complex and there aren\'t easy answers or even easy descriptions
that can be done in three sentences.

I know we imposed that on you, but, I think we ought to reconsider.

MS. SULTON: So you\'re agreeing with we park the T&L issues and that
when we do come back to them we\'ll reference the document and make sure
that we have a consistency?

MS. TUCKER FOREMAN: Yeah, but, I had something that we ought to discuss
before we start and have people agree that that\'s how we\'re \-- how to
handle it or not, because, otherwise, we\'ll never have a chance to
discuss them.

MS. SULTON: Did you want to speak to that point, Greg?

DR. JAFFE: Well, I still want to have \-- know what the process is for
the remainder of the day. But, I want to respond to Pat\'s. I don\'t
know if it\'s the appropriate time now or so forth. I mean, I\'m
comfortable with not necessarily staying to three or four sentences for
certain topics depending on what needs to be done there. I don\'t have a
problem with that.

My general comment, which I felt a lot of the write-ups, there were a
lot of extraneous clauses in lots of sentences, but, trying to balance
things and if we just stuck to the facts, to a factual rendition of the
issue and not extraneous things that try to balance it, and try to
pretend it\'s not an issue, I think in the end the write-ups will get
shorter and there wouldn\'t be these long convoluted sentences.

I think my reading of it, at least a number of the issues and not a
reflection on the Chair\'s draft or anything, but, that there was a lot
of phrases and other types of things in there, although this, although
that, despite this, or, those kinds of things, this attempt to sort of
balance sentences and balance things, my real thing is that we should be
just be putting down factual descriptions of these issues and the
positions or the views on the committee on them.

And I understand these are topics and we\'re just identifying what the
topics are. That doesn\'t mean as though our counter-facts of things
that goes against these or somebody else might else might raise, but, I
think, I don\'t want to get into that mold here. So, I\'m for broadening
them but I also think that there\'s a lot of material in a lot of these
that can be taken out.

MS. SULTON: Michael?

DR. SCHECHTMAN: Yes, a few points, thoughts about this. The first is
that in terms of needing to go back over some and using \-- and making
them more sentences, I think the goal is that the length that we have
these things at now we really should try to make them not any longer
than they are now. If that means just adding commas and a period and
then moving a few ands, that\'s great. If that means changing some
sentences and achieving the same length, that would be okay too from my
perspective.

In the issue of the so-called parked topics or ones for which at least
candidates for just making a reference to the other document, I think
it\'s worth noting that that document was really focused very
specifically on mandatory traceability and labeling systems and it\'s
possible that this report may be addressing some of those things in some
additional context that the other report didn\'t deal with.

So, I think it probably makes sense that the committee is going to need
to have some time to go back and look at these things to see (a) that
they\'re consistent with what was there before and, (b) whether there
was anything new in these that needs to be mentioned or whether simply a
reference is going to be enough.

But, still, I think the idea that we might park these things for the
next meeting or for a work group to go back and look at all of those and
see what needs to be done with them, that\'s certainly something that
can be done. I think we probably don\'t have time at this meeting today
to address those, but, they will \-- you know \-- they\'re not going to
magically disappear. There will need to be some concerted committee
effort to make sure that if there\'s new stuff in them that\'s
important, but, if we can, that they\'re just referenced and the
committee cannot devote a lot of time to them if that makes sense to
everyone.

That would be my suggestion. But, for the third point about \--

MR. DEMORGAN: Hey, Michael, could I just ask the group if that\'s \-- I
mean, given what Michael said, it\'s not a question of whether they\'re
important or not. It\'s just you\'ve spent some time talking about that
general area. In terms of interest of giving yourselves enough time,
especially with the new topics, can we just park these but flag that you
have to make a decision, do you want a work group, or, do you just want
to bring them back on the next meeting? But, is that okay that we park
them away out of this meeting? Is anybody against that?

Okay. So we\'ve got approval of that piece.

DR. SCHECHTMAN: Okay. The third point, and that\'s to Greg\'s point
about recognizing that there are different issues. I mean, I think, you
know, part of the reason that the text was drafted the way it was with
the althoughs and counter-balancing phrases was the need that ultimately
everyone on the committee is going to need to be able to sign off on the
report.

One person\'s view of what the facts are, I think we\'ve had a number of
discussions in the committee where different folks have different views
of the facts. And while I mean I think it\'s undeniable that there are
going to be some issues where there are going to need to be \-- there\'s
a diversity of views on the committee, but, I think, again, the strength
of the committee comes from the places where you can get past the
differences to find the places that you agree on.

I\'m not saying that \-- I mean, I can see certainly several candidates
of issues where that might not be the way that they\'re described
ultimately. But, I think for the most part if we can \-- if the
committee cannot feel compelled to go that way it\'s a useful thing
because I think ultimately everyone on this committee has a say as to
whether or not an issue is described in a way they can live with.

And since there are different views of what the facts are I think you
just all need to be sensitive to the dynamics on that and to what really
can be \-- you know \-- the value in part from an advisory committee as
opposed to a group of individuals is seeing where you can get beyond.
I\'ll just offer that.

MS. SULTON: And speaking to the other point that Greg made about how we
were going to proceed today, this morning and this afternoon, so, we
will focus first on the basic statement of the topic and that we agree
that the statement is the substance of what we want to say and, then
subsequently, if all the sub-points we want to make under that statement
are at least included in the text there leaving us room to go back and
edit subsequent to this meeting.

So, we would put up for your view the statements so you can be very
critical on the statements and then we will just review and see if the
sentences that follow include the items that we want, all the items that
we want included under that statement.

Some members of the committee have noted that perhaps we could split or
lump topics. We ask that probably in the interest of efficiency and time
that we not try to lump and flip here, but, rather just look at each
topic as a stand-alone and see if it is in fact clear. The other things
that there had been discussion in the committee earlier on that we were
not going to have recommendations in the report but really just
statements of the issues.

There may be places in the document where some of the people who
reviewed it have already indicated that there is something that looks
very much a recommendation so a decision needs to be made; is that a
recommendation and do you want it to be worded as more of a statement or
do we want to delete it.

Are those ground rules or is that approach seem to be appropriate? Okay.
Well, then with no further ado let\'s take the first topic.

DR. LAYTON: I do want to have a question. I think there is one place
where someone has pointed out, and as Carol has pointed out, that there
is an issue that probably are identical almost. You just want to ignore
that? Okay.

MS. SULTON: Yes, that\'s what we\'re proposing to do.

MR. DEMORGAN: I mean the only observation I would make, I mean, it is
exactly the same. I mean, you could flag that, just let\'s not feel like
you have to make the decision to strike it or not, but, just flag it.

DR. LAYTON: Okay. Or could flag it.

MS. SULTON: Start on the new issues, number 1.

DR. LAYTON: Okay. Okay. And they\'re really topics.

MS. SULTON: They\'re topics. It says issue but it\'s topics. Lead
topics. As biotech products developed in other countries are imported to
the United States it is important to have adequate regulations and
processes in place to address the safety and to have a plan for
communicating with the public about the products.

There\'s a lot of discussion in here from the comments that we have
already whether the communication system is for communicating about the
regulations or communicating about the product and I believe some
alternative language was offered. If you read the comment side at the
same time as you read the statement side you\'ll see that.

Yes, Greg.

DR. JAFFE: I guess my overall question is what are we referring to here
when we talk about biotech product? I\'m not sure I understand if we\'re
talking about crops, transgenic crops, or transgenic animals. Are we
talking about wood made from genetically engineered trees or paper made
from genetically engineered trees? Are we talking about \-- what are we
talking about here because the initial one doesn\'t really identify it?

And then, clearly, the following sentences keep going back and forth
about food and feed, about crops for approval and products for approval.
I mean, I don\'t \-- I tried to get a feel before I can go to my other
comment of what is the scope of what we\'re discussing here in terms of
that? And we need a phrase for what we mean by it.

DR. LAYTON: And we need to go back to our document.

DR. JAFFE: I understand. Biotech, I\'m not \-- the biotech I understand
we can put transgenic in there or genetic engineering. I don\'t want to
get at that. I\'m trying to get the word product in particular as to
what is this issue referring to?

MS. SULTON: How broad, what are we talking about when we say products
here? Was anybody on the draft of this topic? Michael?

DR. DYKES: I think I was on the conference call on this, I don\'t
rightly remember, but, nonetheless, I thought from the discussion we had
last time, Greg, I think your question is a valid question. I think my
recollection from the last meeting, what we were talking about here was
primarily around crops that were going to be introduced into other
countries and we talked about it here too, the BT rice, the transgenic
rice was one. I think we probably should include possibilities of PMP\'s
that may be produced in another country.

I would assume we should talk about \-- we should include possibly
transgenic animals that may be involved since this committee is doing
animals as well.

DR. JAFFE: I guess what I\'m saying is, though, are we worried about the
BT rice coming in and somebody\'s going to grow it? Are we talking about
importation of a genetically engineered organism? Are we talking about
the rice meal that the Chinese grind up and then is imported to some
Chinese store in New York City Chinatown? Are we talking about both of
those? I think we need to specify because people, when you say biotech
products, I don\'t think people are going to understand what we\'re
talking about.

And, clearly, for regulatory systems, I don\'t know anybody who
regulates the rice, you know, the rice meal imported. I mean, I just
think there are very different kinds of regulatory systems, very
different issues. I don\'t have a problem putting them in the same one
but we need to specify and explain what we\'re talking about.

MS. SULTON: Mardi?

DR. MELLON: Well, I agree that it\'s a point well taken but I think the
purpose of this is really to provide, you know, a heads up to the
Secretary that all of a sudden we are no longer \-- all of our problems
are not simply the export problems. We\'re now going to have to face
problems as an importing country.

So, I think the scope, you know, should be crops, animals, and trees and
products made from them. I don\'t think we can address here, you know,
how we\'re going to address it. As you said, a lot of the products of
the things made from biotech products are going to be \-- they\'re just
not going to be \-- they\'re not going to be visible in our system
because it just doesn\'t pick those kinds of things up, but, that isn\'t
our point.

It\'s just to raise that flag and say we\'re going to start thinking
about it coming in. So, I would say a broad scope, you know, mentioning,
you know, and I think all of those are important crops, animals, trees,
and products made from them, you know, are likely to be imported into
the U.S.

DR. SCHECHTMAN: Well, that\'s just plants and animals.

DR. MELLON: Plants and animals is fine.

DR. LAYTON: Can we say transgenic organisms?

DR. MELLON: Yeah.

DR. LAYTON: And products made from them.

DR. JAFFE: And products made from them.

DR. LAYTON: Carole?

DR. CRAMER: I think that we also ought to replace exported to imported
into because what we\'re really highlighting is the concept that now
we\'re talking the other way around.

MS. SULTON: It would make it read clearer. Is everybody okay with that?

MR. SLOCUM: Carole\'s suggestion as edits.

UNIDENTIFIED MALE: Is there another change on this?

DR. JAFFE: So, it would say transgenic organisms and products made from
them. How about as transgenic organisms developed in other countries and
products made from them?

UNIDENTIFIED FEMALE: Are imported.

DR. LAYTON: Are imported into the United States.

MS. SULTON: Okay. Is everybody okay with that statement? Mardi?

DR. MELLON: Hold on. I just wanted to raise my concept.

MS. SULTON: So now we\'re going to go to the concepts that are listed
under it?

DR. MELLON: Yes.

DR. SCHECHTMAN: Well, is it the concept that\'s later in the statement?

DR. MELLON: No, it\'s just a concept that I thought was missing in the
discussion.

MS. SULTON: You have a point of concept? Okay. Mardi and then Greg.

DR. SCHECHTMAN: I don\'t know that we\'re through with the topic
sentence.

MS. SULTON: Are we finished? You\'re not through with the topic
sentence. All right. Greg?

DR. JAFFE: So, the second part of the topic sentence I had a question on
was it says adequate regulations and processes. I don\'t know what
we\'re referring to when we say processes other than regulations.

DR. LAYTON: You better believe quarantine and inspections is a very big
process for wood side.

DR. JAFFE: They\'re a part of regulatory systems so I\'m not sure. I\'d
rather put of adequate regulatory systems in place and you could then
capture. I don\'t think processes to me captures quarantine and things
like that.

DR. LAYTON: I just want to make sure that it\'s just not a regulation,
it\'s a process. I mean, it\'s a thing.

MS. SULTON: So, these processes are in support of the regulation?

DR. DYKES: I think regulatory system is going to be an all encompassing.

DR. LAYTON: To have regulatory systems.

MS. SULTON: So changing regulations and processes to regulatory system.
Is everybody okay with that?

DR. JAFFE: Yeah.

DR. DYKES: That\'s in Daryl\'s comments.

DR. JAFFE: And my third question is, I don\'t understand the
communication plan with the public about the products. First of all,
it\'s not really discussed in the details for discussion below and, so,
I\'m not sure why it should be in there, but, if we\'re going to have it
I guess I have a couple of comments.

One is, I mean, if we\'re talking about communication plan for the
government to have a communication plan or is it about industry or I\'m
not sure who\'s having the communication plan.

But, assuming it\'s the government that\'s having a communication plan
then the question is I think I\'m comfortable with them having a
communication plan about the safety of the products, but, a
communication plan about the products, that, to me, is too broad. I
don\'t want the government to go out there and advocate those products
and other kinds of things.

I think you need to be specific about what we\'re talking about.

MS. SULTON: Did you see Daryl\'s rewrite there on the right-hand side? I
think he spoke about that.

DR. JAFFE: But, I could not \-- it just didn\'t have red line
strikeouts. It was very difficult to follow what the rewrites were.

MS. SULTON: It\'s a rewrite of the issue about the communication and it
doesn\'t speak \-- I think it speaks to your question, Greg.

DR. LAYTON: Actually, I think his write-up is just a total revamp to
kind of make structure better so if you read it, and I don\'t think
Daryl tried to change the concepts there, so, if you read it as a whole
does it seem to flow for everything better?

MS. SULTON: Right.

MR. OLSON: I just had a question. This implies that we don\'t
communicate about U.S. biotech-derived products, but, we are going to
communicate about imported biotech products. What\'s the difference?

DR. DYKES: Why would we communicate?

DR. LAYTON: Okay. So, I hear a thing to end it after safety?

MR. OLSON: Yeah.

MS. SULTON: You want to strike this? Jerry?

MR. SLOCUM: Yeah, I\'d end it after safety period.

DR. LAYTON: Anybody challenging ending it after safety and to all the
communication plan? Carol? Everybody\'s okay? I see nodding around of
the heads. I don\'t see anybody having a cow.

MS. SULTON: Anything else on the statement. We\'re comfortable with the
statement. How about all the concepts underneath, do we have everything
that we want to say included?

DR. VAN EENENNAAM: I like Daryl\'s rewrite.

DR. DYKES: I like Daryl\'s rewrite. They got the word and communicated
in it in the last sentence and I like Daryl\'s rewrite.

DR. LAYTON: Implemented and enforced?

DR. DYKES: Implemented and enforced and enforced in a manner. I think
that strikes the balance of systems and all the things we\'ve talked
about.

MS. SULTON: So, all concepts there, but, we\'re feeling more comfortable
with Daryl\'s rewrite.

MR. DEMORGAN: That\'s the one that begins U.S. regulations?

DR. LAYTON: Yes, and procedures.

MS. SULTON: Wait. Strike and communicated from it.

DR. LAYTON: Okay.

MS. SULTON: Okay. All right. One more? I\'m sorry, Greg?

DR. JAFFE: I guess, I mean, I\'m comfortable generally with Daryl\'s
rewrite. I do think that you need to substitute for biotech crops and
biotech products, the language we had above there about transgenic
organisms and products made from them.

MS. SULTON: So we\'ll make that consistent with the change in the
statement.

DR. SCHECHTMAN: Let\'s make a \-- we will, in working on the Chair\'s
draft, the next version that you see will have specifically all of that
stuff fixed. And if there\'s a place where there\'s an ambiguity we\'ll
try to raise it if we see it. We might miss some, but, we will try that
in all of the text that we receive from this point. We\'ll try to put in
suggested fixes for all of that stuff.

MS. SULTON: So, we change a word in the statement we\'ll make sure it\'s
changed in the body.

MR. DEMORGAN: And just to be quick, we wanted "and communicated"
stricken?

DR. LAYTON: Yes. So, it\'s implemented and enforced.

MR. DEMORGAN: In a manner that.

DR. LAYTON: Yes.

MS. SULTON: Anything further on this topic before we go to topic 2?

DR. JAFFE: The only thing that I have on Daryl\'s is that it is very
specific to the food and feed system. Are we limiting ourselves here to
things that are only in the food and feed system, not PMIP\'s, or,
PMP\'s, or, trees or something like that, but, both of the sentences
talk about import of food and feed, environmental safety, and then the
bottom one talks about enforced in a manner that maintains confidence in
the U.S. food and feed systems.

I mean, the suggestion is that we\'re really talking about products that
are going to go in the food and feed system as opposed to other things
and I\'m just asking whether that\'s the scope we want.

MS. SULTON: Do you want it broader, any broader in the statement?

DR. LAYTON: Okay. Is the agricultural system better? Because that covers
\--

DR. DYKES: I think Greg\'s going to say it should include
pharmaceuticals, for example.

DR. JAFFE: Or trees.

DR. LAYTON: Well, trees is an agricultural product. We\'ve got
environmental safety in there.

MS. ZANNONI: The pharmaceutical could be national systems anyway. It\'s
not like because pharmaceuticals have to be registered in the countries
that they\'re sold in. It wouldn\'t be the same as food and feed flying
across the border. Isn\'t that the point, that it could go across
without an approval? And pharmaceuticals wouldn\'t do that.

MS. SULTON: Carol, did you have a point? And then Duane.

MS. TUCKER FOREMAN: I\'ve changed my mind. Thank you.

MS. SULTON: Okay. Duane?

MR. GRANT: There was a way to address that issue, I think it\'s a valid
issue, if we put a period after the U.S. must ensure food, feed, and
environmental safety period. It must be approved before entering the
domestic food and feed system.

MS. SULTON: I\'m sorry, say that again.

MR. GRANT: Okay. The way that Carol said it that you all suggested edit.
It says U.S. regulations and procedures for review \-- that sentence.
Okay. And the third line down. Available for import into the U.S. must
ensure their food, feed, and environmental safety period.

DR. LAYTON: I think that Greg\'s saying is it really also would include
fiber because fiber\'s not food/feed. Cotton and trees aren\'t food and
feed, although they can be used as food and feed. They\'re not generally
used as food and feed.

MR. GRANT: So, what \--

DR. LAYTON: And, so, that\'s where I think Greg is going is that bigger
than food and feed.

DR. JAFFE: I\'m not expressing a viewpoint. I\'m just saying as written
it\'s limited to \-- we\'re the ones who are limited to things that are
affecting the food and feed supply. I think what Duane is suggesting is
eliminating the limitation. I would just \-- I\'m not \-- I don\'t feel
strongly one way or the other. I just was pointing out that it\'s
limited.

DR. LAYTON: An ambiguity.

MR. GRANT: And it seems to me if you pick up primarily on safety that
pretty well covers it, I mean, other than I suppose wearing safety as in
the context of talking cloth you might wear, but, that\'s not food but
that would be human safety, I guess, I don\'t know. That would be an
issue there.

DR. LAYTON: Yeah, I\'m fine.

MR. DEMORGAN: So, I missed Duane. Just so if you\'re looking up here I
accepted this with a note, this was the intention, Daryl, so you can see
the edits we\'re making to Daryl\'s language. Otherwise it was edits on
edits. So your question was, right here, put a period?

DR. LAYTON: Yes.

DR. BUSS: Yes. And then deleting the rest of it and then eliminate
everything down to the next period.

MS. SULTON: Okay?

DR. LAYTON: And the only other concept that I had was at the end and the
U.S. food and feed system or is it in the U.S. agricultural system? And
I think it\'s food and feed and I\'m okay with that even if fiber\'s not
in it.

MS. SULTON: Anybody?

MR. GRANT: I have only one other question on \-- it\'s both in the
original and in Daryl\'s edit, the word at least equal to. That implies
that we could place restrictions on imports that would be more
restrictive than those placed on domestically produced. And although I
wouldn\'t object in the case of products that I produce.

MS. TUCKER FOREMAN: We\'re always for the highest standards so you want
to put a higher standard on imported products, that\'s fine.

MR. OLSON: But, there could be a product we don\'t have here because
it\'s not equal to. There might be a new product coming, so, what is it
equal to.

DR. DYKES: Are you saying the product must be equal to or just the
safety has to be equal to?

DR. LAYTON: The regulations and procedures are equal to.

DR. DYKES: Those standards for domestically developed items.

MS. SULTON: Their standards could be greater than ours is what he\'s
saying.

MR. OLSON: I would suggest you just take out the words at least.

DR. SCHECHTMAN: If I can just mention, I think where this came from in a
discussion in the work group was the concept that products that might be
coming from places where you had less confidence in the type of review,
or, the safety assessments, or, the data that came in that they were \--
that that little bit of buzzword and I think that was where \-- that was
where people were coming from in that discussion.

DR. LAYTON: We need to move on.

DR. SCHECHTMAN: So where is that?

DR. LAYTON: To reduce the commercial risk.

MS. SULTON: But, we\'re leaving it as is.

DR. LAYTON: We\'re going to leave it for right now. We\'ve got another
chance at it. We need to move on.

MS. SULTON: Mardi?

DR. MELLON: It\'s gone right now.

MS. SULTON: Okay.

DR. LAYTON: It\'s back in.

DR. MELLON: And it does read at least it\'s equal to ours so if theirs
could be as good as or better than.

DR. SCHECHTMAN: No, no, no.

DR. LAYTON: Our systems are good.

MS. TUCKER FOREMAN: She\'s right, Michael.

MS. SULTON: Mardi?

DR. MELLON: I was going to move on.

MS. SULTON: Okay.

DR. LAYTON: Okay. Let\'s move on.

MS. SULTON: Issue number 2.

DR. MELLON: Well, no, I was actually going to \-- I wanted to \-- under
concept, issue number 1. I don\'t want to wordsmith it at all, but, I
think it\'s important out there that we understand that one implication
of this stuff coming our way is that there will be contamination of
those grain products, for example, with adventitious presence from the
field trials being conducted with unapproved products being grown in any
other country.

So, this, I don\'t want to \-- it\'s a huge issue, but, I think it\'s
something that ought to be taken on by the Secretary in terms of
thinking through adventitious presence is that we not only have to think
about, oh, it won\'t be anything but some BT from here in the U.S. We
have to say what kinds of traits is China testing and introducing and we
have to face the fact that their grain supply is going to be
contaminated at low levels with all of those traits and I think that\'s
just an issue we need to think about partially from a substantive point
of view and partially in terms of whatever we impose on ourselves.

DR. LAYTON: Okay. My note is understand the implication of AP presence
in imports.

DR. MELLON: Right, and that would be fine.

MS. SULTON: Any other concepts missing from this statement? Okay. Then
we can move to the second topic. To reduce the commercial risk
associated with supplying ingredients based on transgenic testing
results. This is one we\'re going to park because it does \-- it is, in
fact, related to something we talked about in \--

DR. LAYTON: Let\'s park it.

MS. SULTON: We\'re parking it. Moving to 3. And 3 reads, given the
importance of trade to the U.S. economy, continuing controversies and
the growing complexity of biotechnology it is important to anticipate
the technical expertise in staffing needs both domestically and
internationally in order to respond to information needs regarding
modern biotechnology products.

There are some questions raised on this in the comment section that were
presented beforehand by both Greg and Mardi, both of which talked about
staffing at U.S. embassies and asking whether \-- what exactly are we
clear on, what staffing issues we\'re talking about in the statement,
and which ones should we be referring to.

Mardi offered us a little \--

DR. LAYTON: I was going to say, one thing I think we did when we brought
this issue up at our last meeting in August it was both our embassies
overseas, our own federal staffs, and those of other countries, as I
remember, what we were trying to go after from my last discussion. Did
we get that in the statement, I don\'t know.

MS. SULTON: The question becomes did we get enough in the statement so
we can elucidate the listing of what exactly you need in the paragraph
that follows, or, you know, do we need more in the statement?

Carol?

MS. TUCKER FOREMAN: Having even before there at that meeting I don\'t
understand what this is about. I think you have to say straight out
that, and I assume that Mardi\'s right here, that we\'re going to have
to develop staff at USDA or at AID and other places who understand these
needs.

Then I want to know why.

DR. LAYTON: Well, and I\'d just point out that the one \-- that there\'s
two issues on the staffing issues. One is the next one also. It\'s about
the lack of capacity in the poorest countries too. So, you want to make
sure they understand we\'re going to come back to this again. This
one\'s only the U.S. staff. Because I misspoke. That\'s what I said
there\'s two.

MS. SULTON: All right. Greg?

DR. JAFFE: I mean, I still don\'t understand the issue or what the
sentence states the issue as. I do understand what the information needs
are and who has the information needs to understand who to respond to
those information needs and I do not understand, are we talking about
technical issues; are we talking about staffing issues? We seem to be
lumping. We seem to be lumping a lot of things together and I cannot
understand.

And the importance of trade to the U.S. economy, I mean, a lot of this,
to my understanding a lot of this stuff is for embassies in Africa and
we do so little, particularly so little agricultural trade to Africa,
and I suppose from an economy point of view, except we get food aid, we
don\'t get paid for it. But, no economic benefit to that. You know, I\'m
uncomfortable given the importance of trade. The trade may logically be
Europe or Japan. I think those embassies are pretty well staffed on some
of these issues.

So, I\'m trying to understand what the information needs, what is the
technical expertise of the staffing you were talking about, what is the
information, the content part, what are the questions?

MS. SULTON: Michael, go ahead.

DR. DYKES: I\'m kind of where Mardi\'s comments are here. When we talked
about this last time we had talked about how the different applications
of biotech with different questions in order to build capacity in some
of these countries that we needed people with some specialized expertise
in the field of biotech to go beyond what our ag attaches and
agricultural counselors have that are more or less generalists.

And, we even went so far as to talk about how these may be regional
experts that can (1) answer the questions for other countries as to what
the U.S. risk assessment review process is; how detailed they get; those
kinds of questions rather than have to bring \-- rely on the people that
are based here to always fly around the world to do those kinds of
things.

DR. SCHECHTMAN: And I think it\'s worth pointing out that from my past
days working for the regulatory agency, folks in the regulatory agencies
were in great demand to go to embassies to discuss how the regulatory
process works in more detail, specifically how particular safety
assessments were generated, what data was considered, etc.

DR. DYKES: And I think that\'s what this is trying to get to is just
expand that beyond so it\'s not all based in Washington but you have
people out, maybe not in any of the embassies, I recall from our
conversation, but, maybe in regional bases. Maybe if the U.S. Mission to
Brussels, for example, that covers Europe.

MS. SULTON: Both Jim and Lisa have their cards up. Jim, are you going to
explain that for us?

DR. MARYANSKI: Well, I don\'t know how to explain it. I\'m just like
Michael. From the, you know, regulatory perspective I had some
experience, a bit of experience in this, and I think if you want to
advocate having, you know, experts, more experts out there, you need to
explain what that need is and how those experts are going to be
maintained because my experience is that the people in our embassies,
for example, rely on the agencies in Washington and the questions. They
are a conduit to bring the questions back so that they can get, you
know, the most recent information that they can provide.

And it\'s hard for me to imagine how someone in a regional post or an
embassy can really be on top of the issues continuously, more than for,
say, a short period of time. Now, I\'m not saying that the idea doesn\'t
have merit. I just think it probably needs to explained better of how
this would be accomplished relative to all the other issues. You know,
this is one issue, of course, not an unimportant one, but, out in, you
know, the number of people that the U.S. can post, there are obviously
lots of issues and that\'s why the people are generalists.

So, I just think there\'s \-- you know \-- something needs to explained
in terms of how this will function.

MS. SULTON: Lisa, did you have a comment?

MS. ZANNONI: Yeah, and I agree. I think it\'s more toward the regulatory
aspect than \-- because I would see it more important for importing
countries like the APEC countries because they ask companies how systems
work, you know, how the U.S. system works and stuff when we go in to
them.

And it really should be the U.S. Government having somebody there
talking about their system and some of the issues there instead of
relying on different companies. But, again, my company, or, Monsanto,
they might get two different opinions of what\'s going on, so, and you
don\'t develop this stuff, so, they don\'t see all that\'s going on,
information, that kind of thing since they\'re importers.

MS. SULTON: Carol?

MS. TUCKER FOREMAN: I think what I see working here is a suggestion that
we hire more federal employees. The FDA tells me every time I want them
to enforce something that they don\'t have enough enforcement people to
do it and the OMB has told USDA they\'ve got to reduce the number of
meat inspectors. I think it\'s perfectly appropriate for companies to be
doing this.

I have a really hard time suggesting out of context that they should go
out and hire a bunch of people to do a job when there are a lot of other
competing demands.

DR. LAYTON: So you would suggest we draw up this issue?

MS. TUCKER FOREMAN: Either that or it has to be

\-- I don\'t know how to qualify it to say in the context of other
needs.

MS. SULTON: Mardi, then Bob.

DR. MELLON: I don\'t feel strongly about this at all except to the
extent that I \-- I mean, to me the important message we\'re sending to
the Secretary is if you\'re going to continue to, you know, basically
let biotechnology, which is a very, very controversial technology, be
the vanguard of our ag policy then you\'re basically going to have to
spend a lot of time and money on dealing with these controversies all
over the world and that it really \-- there will be kind of requests for
information about regulation and that will \-- you know \-- that kind of
comes out of that decision to give this the priority it\'s been given in
the past.

Whether, you know, they \-- I mean, so that to me is the \-- that to me
is what I would see important in taking up to the Secretary is that
there are staffing implications continuing to go ahead with a technology
that you\'re going to have to explain every day from all around the
world.

MS. SULTON: So you\'re suggesting that if this continues to be the
forefront then?

DR. MELLON: Well, I just \-- I mean, I don\'t mind having it in here. I
also don\'t mind, you know, losing it. I don\'t think it\'s a big \-- it
is a \-- it isn\'t \-- you know \-- it\'s a real important issue.

MS. SULTON: Okay. Bob and then Jerry.

DR. HERDT: Well, I agree with Carol that we shouldn\'t have a
recommendation for staffing or expenditures in the absence of the whole
pie, of the whole thing. And I think that I\'d be happy to drop it. To
keep it, I think we need to suggest that there be some shifting maybe to
achieve this additional expertise, shifting of it toward more people
with these capabilities and fewer people maybe doing some other things.
That\'s the only way you\'re going to do it, more staff.

MS. SULTON: Jerry?

MR. SLOCUM: Our personal experience with soybeans is when soybeans were
exported to Europe. It was appalling at times how unaware or how
uneducated the U.S. staff at its embassies were with respect to the
dynamics about trade revolving around biotechnology. I think there were
enough people in place. I think it\'s a simple matter of
re-prioritization of what it is they do and some education, you know,
some technical education and not in the sense that you make them, you
know, molecular biologists, but, just to understand the U.S. system and
to understand the processes that a product goes through before it\'s
allowed to be planted and exported.

And to understand, a lot of these folks have a much better understanding
of the importing country\'s regulations than they do of the procedures
and processes in place in the U.S. So, I don\'t \-- I agree, I don\'t
think we need more people, I think it\'s just a re-prioritization of
what is they do and what it is they communicate and what it is they
know.

DR. LAYTON: And, so, a continuing education of \--

MR. SLOCUM: No, I don\'t think it\'s continuing. In most places it would
be a starting.

DR. LAYTON: For education of existing staff.

MR. SLOCUM: There\'s been some attempts at that because I\'ve been
involved in some of those attempts and the people are anxious and
willing to learn it, it\'s just not made a priority so it\'s not what
they think about when they get up in the morning.

MS. SULTON: This actually speaks to the question Greg raised in the
promise.

DR. JAFFE: Right. So, what I\'m hearing, and I started to write down,
jot down something that might be of some topic sense, is that to answer
other countries\' questions about the regulation and safety of
transgenic organisms, because that sounds like what Lisa told you we\'re
talking about, it\'s not information needs, it\'s specifically about
regulation and safety of transgenic organisms, existing staff at
embassies or USAID or whatever, I mean, existing staff at blank need to
be educated about the regulatory system and the products that have been
approved in it, something like that.

MS. SULTON: So USDA is keeping the foreign \--

DR. JAFFE: The regulatory system, about the regulatory system and the
products that have gone through it or something like that. Well you
can\'t be equal about things that are going to go through it. You only
can educate them about the products that have gone through it. You
can\'t \--

DR. MELLON: And since we\'re getting ready for cloning it wouldn\'t be a
bad idea.

MS. SULTON: So when we say USDA needs to be educating the people who are
stationed overseas, the embassies or under the offices of organizations
like USAID as to the most current regulations and processes, etc.

MR. SLOCUM: I mean, a good number of these personnel are foreign
nationals that don\'t grow up in the U.S. and don\'t understand FDA and
EPA and USDA and may understand USDA, but, they understand the Foreign
Ag Services primarily about USDA.

MS. SULTON: So, it\'s not \--

MR. SLOCUM: It\'s just a basic educational effort that if done and
accomplished will go a long, long way toward addressing this.

MS. SULTON: So, it\'s not just federal employees but the employees of
those agencies.

DR. JAFFE: They\'re not U.S. citizens. Half of the embassy staffs are
usually \-- they\'re locals.

DR. HERDT: Assume that, you know, we\'re adding another idea here and
it\'s going to be distinguished. We\'re instructing the whole \--

MS. SULTON: A restatement of the topic.

DR. JAFFE: The first part was \--

MR. DEMORGAN: Yeah, that would be helpful because this is really a
recommendation, not a topic.

DR. JAFFE: Well, I mean, the first part was to answer other countries\'
questions about the regulation and safety of transgenic organisms.

MR. DEMORGAN: The regulatory?

DR. JAFFE: About the regulation and safety of transgenic organisms.

MR. DEMORGAN: So, you may want to address moving your approaches, topic
sentence discussion. Then the topic is \--

DR. JAFFE: Right, this may not be \--

MR. DEMORGAN: So I\'ll just put it in here like this.

MS. SULTON: Carol?

MS. TUCKER FOREMAN: I think this is much better. However, I thought we
had agreed not to make recommendations.

MS. SULTON: Right.

DR. JAFFE: Right.

DR. LAYTON: But, if you all agree this is a recommendation and we all
feel comfortable with it you don\'t want to do it?

MS. TUCKER FOREMAN: Not until I see how many other recommendations
we\'re all prepared to agree to.

MS. SULTON: So we could say this is a restated rather than a
recommendation, a statement of a need.

MR. OLSON: Existing staff lack or something like that.

DR. CRAMER: Or it is important that. And I think we should take existing
since, again, that\'s a judgment call to say staff. It is important that
staff are better educated.

MS. SULTON: Carol?

MS. TUCKER FOREMAN: That by taking existing out suggests we\'re going to
hire new people.

DR. CRAMER: It makes no judgment whereas existing makes a judgment.

MS. TUCKER FOREMAN: I think it\'s a springboard for people to ask for
more staff. We don\'t have anybody now. We\'ve got to have somebody who
knows.

MS. SULTON: Well, we could phrase it in a way that talks more about
training and education than about expanding staff.

MR. OLSON: The existing staff are educated which is what I was hearing
and future staff won\'t be?

MS. SULTON: No, just staff.

MS. TUCKER FOREMAN: Oh, I\'ll agree to that. If staff were educated.

MR. DEMORGAN: So, now it is a topic statement, right?

MS. SULTON: Yes.

MS. TUCKER FOREMAN: Could we say it would be useful instead of it\'s
important? I don\'t care as long as it\'s adequate. As we look at all of
our issues here is this one important in the context of the things
we\'re saying.

DR. LAYTON: Can we move onto the next one? That\'s not a question.

MS. SULTON: Yeah, I think we have the sense of the statement. I see
Carol nodding. We also know we have the general sense of what this topic
is about.

MR. DEMORGAN: So, just to be clear, I mean, strike that whole thing?

MS. SULTON: Right. You strike the whole thing.

MR. DEMORGAN: And that\'s a new topic statement?

MS. SULTON: That\'s a new topic statement. So, all the concepts listed
here.

DR. JAFFE: I think we need to rewrite the whole thing.

MS. SULTON: Does anybody have anything they want to make sure is in
there that\'s not there before we move onto the other? The next one \--

DR. SCHECHTMAN: Hold on. I think I\'m not entirely clear specifically
what to rewrite.

DR. LAYTON: We\'ll work on it.

DR. SCHECHTMAN: I just wanted to get just a quick sense of what they
want to see in the text underneath. What they want removed or what they
want \-- you know \-- just from an idea standpoint, not from changing
the text substantively.

MS. SULTON: Greg and then Carol.

DR. JAFFE: I mean, I think based on this what you\'d want to do is
articulate in a sentence at least what other kinds of questions \-- the
information that\'s being asked because you\'re sort of saying to answer
questions about it you might give some context, a little more detail
about that. I think you also need to get Mardi\'s statement in there
which sort of suggests to the extent that biotech continues to be a
major component of our agricultural production system that these type of
issues will arise and may need priority.

I mean, I think her concept is that you need to put in this \--

DR. LAYTON: It\'s a growing area.

DR. JAFFE: It depends on \-- the whole point of this topic is it depends
on the role of biotech in the future, five to ten years from now.

DR. SCHECHTMAN: Okay. Thank you.

DR. CRAMER: This is actually Jerry and I are chatting over here, but,
sort of a nice way to articulate the importance of these as a conduit
for information and direction and, so, that sort of \-- you know \--
recognizing the role of these staffers as conduits of information I
think is something you ought to highlight.

MR. SLOCUM: Just one thing. When the Chinese exporter starts to send
that bioengineered potting plant to the United States he\'s going to go
the ag guy in Beijing. That\'s where he\'s going to start. That\'s his
contact with the American government and American people. That\'s where
he\'ll start. If he has trouble that\'s where he\'ll go.

MS. SULTON: So we\'ll move to issue number 3 \-- 4. The lack of capacity
of the poorest developing countries to address scientific, intellectual
property, regulatory and international negotiation requirements related
to biotechnology will have an impact on the growth of U.S. food and
agricultural exports in the future.

Comments provided from Alison and Mardi and Greg. Alison was kind of
reluctant so we will come back to that. Greg\'s question was whether
this would really have a major impact on imports.

DR. JAFFE: I mean, my first comment was I guess I just sort of didn\'t
agree with the premise of the topic\'s end. We\'re talking about the
poorest developing countries and our food and agricultural exports. I
don\'t have the numbers in front of me, but, it\'s got to be so, so,
minuscule, again, the paying exports that we give to the poorest
developing countries, we\'re talking about the inner parts of Africa.
We\'re talking about the island nations. We\'re talking things like that
that I guess I disagree with that whole premise in the topic.

That doesn\'t mean that there\'s a capacity, a lack of capacity in
biotech, and I don\'t dispute with that, but, as that \-- in having an
impact on the growth of our agricultural exports in the next five to ten
years I really didn\'t see that as a major issue to our exporting
agricultural exports to those countries to the extent that we would
increase them.

Even if we increased them by a thousand-fold they would still be such a
minuscule portion of our imports/exports.

MS. SULTON: So you\'re agreeing that the expertise in a country is
important but that the premise that was put there for why it is
important is the question?

DR. JAFFE: Yes.

MS. SULTON: Carol?

MS. TUCKER FOREMAN: I have questions about whether the U.S. should take
this obligation on. As I recall, Gordon Conway, the former president of
the Rockefeller Foundation, said years ago, suggested that the biotech
producers band together and set aside a certain amount of their profits
from biotechnology each year to help fund international development so
that these developing countries could have scientists and the expertise
to, again, use biotechnology.

Again, this is a suggestion for spending federal money and I have
trouble with it.

DR. VILKER: I would just observe that FAO does a lot of that. WHO has a
mechanism for \-- they\'re trying to do that. It\'s an observation.

MS. TUCKER FOREMAN: You mean we should pay our dues to the UN and maybe
they \--

DR. VILKER: Well, I\'m making the observation that we\'re not \-- the
world is paying attention and there are other people besides the U.S.
Department of Agriculture trying to promote and handle these issues and
it probably would be best if we integrated with those efforts rather
than struck out in a new direction.

MS. SULTON: Duane?

MR. GRANT: So I\'m definitely not an expert in this area, but, I would
observe that in several conferences that I have attended where there
have been representatives of the regulatory system as they are in
developing countries, or, are not, there has been repeated requests from
those individuals or speaking for their governments or their developing
regulatory agencies for assistance in capacity building.

We heard that over and over again. So, then the question becomes where
do they receive this assistance and what types of systems does the
assistance start to engender within developing countries and I think
that\'s our interest in the U.S., to foster development systems that are
based in our concepts of risk assessment and risk management versus some
other concepts that are out there.

But, I do think it will have eventually an impact on the growth of U.S.
food exports because systems that are developed in the developing worlds
will either accommodate our system of regulation or conflict with our
system of regulation.

MR. DEMORGAN: I just had a question which was, you know, the way Greg
\-- I thought what Greg was really pointing to was put the use of the
word poorest. If you look \-- no? Oh, any developing country.

DR. LAYTON: No, I don\'t think \-- they don\'t buy a lot of food.

DR. JAFFE: I don\'t think either way. I agree with \-- I completely
agree with everything Duane said except for the last part which says I
think it\'ll impact our exports. I agree that they lack capacity and
they need help with capacity in this area and, in fact, I helped them.
It\'s what I do with USAID, so, I try to get involved in that aspect.
So, I agree with everything there.

I just don\'t think even if you got rid of the poor, I mean, we were
trying to get poorest so we weren\'t trying to address India and Brazil,
and the other countries that are considered developing countries by
certain World Bank and other kinds of things. That may or may not be
developing countries. It may or may not need this kind of help. So, I
think building the poor or the poorest doesn\'t make the difference,
but, I was questioning the impact on exports.

But, I agree with Duane on the capacity issue.

MS. SULTON: Carol, Jim, and Bob.

MS. TUCKER FOREMAN: Well, I\'d be okay if we said that the Secretary
should encourage corporations and non-profit organizations to fund
efforts to do this work.

MS. SULTON: That would be a recommendation.

MS. TUCKER FOREMAN: Yes, it would be, but, to shorten it, I\'d be in
favor of suggesting that this is an appropriate thing to be done
non-governmentally.

DR. JAFFE: But, could we just not have a recommendation at all and just
sort of say, talk about there is lack of capacity in poor countries and
that they don\'t have a great knowledge of this technology and the
products from it.

MS. SULTON: So that the statement focuses on the capability. Jim and
then Bob.

DR. MARYANSKI: Well, I think that was the point I was going to suggest
is that I see a tremendous increased demand already coming in for
information in this area and certainly there\'s going to be an impact on
U.S. agencies to provide their experience, but, I think, you know, it\'s
a multi-faceted issue. FAO certainly has a role. So, does industry and
other organizations. So, it\'s not something that\'s all government.

But, I think maybe an issue here is that there\'s going to be an
increasing demand, not just from the poorest countries, but, from any
country or region that doesn\'t have the same level of experience.

MS. SULTON: Bob?

DR. HERDT: Yes. Well, I think the lack of such capacity in the poorest
countries has already absorbed a lot of the U.S. resources in dealing
with issues. It has caused a big, huge discussion in the case of food to
Southern Africa. I mean, this has become a big thing because, I believe
because people don\'t have \-- don\'t have the capability in their own
country to turn to. That\'s number one.

Whether \-- I accept Greg\'s point that currently, and maybe in the near
future, it\'s not going to impact on U.S. exports to these countries,
but, we do know that if we begin to get some economic growth in these
countries in a respectable way food imports to those countries will
increase very rapidly. We know that from experience with countries that
have had rapid growth. We can only pray for rapid growth in Africa, but,
we need it and we can hope that we\'re going to get it.

Whether it\'s the U.S. Government\'s responsibility, I agree that we
shouldn\'t increase our deficit, but, it\'s our long tradition that we
sponsor education. People are going to reach for education. They\'re
going to get it somewhere. We have practically eliminated our national
support for long-term education of people from developing countries. I
think it\'s something we need to add back in.

I\'m not going to, you know, insist on it. If the committee doesn\'t
want to put it in here, that\'s fine. But, I really do feel strongly
about it. And, yes, Gordon Conway urged the companies to do that. I
would urge the companies to do it as well. They ought to take part of
the responsibility and if I had a bigger pulpit I\'d give a longer
speech about it.

DR. SCHECHTMAN: Just two observations. One is that in terms of affecting
the overall trade picture in the world, I participated in the
negotiation around the Biotech Protocol and what one heard from
developing countries over and over again in the discussions was, we\'re
worried about this and we want to put in place, this particular
instrument, because we don\'t understand and we don\'t have the
technical capacity to address these things.

So, certainly from the point of view of having potentially broad impact
on international trade regardless of whether or not it was for the
specific trade to that country, that was certainly one place where this
perceived lack of information did have, I think, some impact.

I think the other point that I would make though is that this isn\'t
entirely a recommendation for new efforts because it is something that
USDA, the regulatory agencies, do work at, capacity building to groups
of the poorest countries. There\'s, you know, a staff that\'s involved
in doing that. USAID does it as well. So, it\'s not entirely new, not
entirely new staff. Just throw those out, a couple of observations.

MS. SULTON: Mardi and Daryl.

DR. MELLON: Well, what appeals to me about this is that I want the
poorest countries of the world to be basically in a position where it\'s
in their interest to fight off the U.S., you know, to have the capacity
to have enough technical expertise in their country to make their own
decisions about whether biotech is good for them.

I don\'t think that in all cases it is or needs to be, and I\'m
uncomfortable with the idea that we use all of our expertise to simply
build capacity so that they can say yes to us. I am much more enamored
of the idea that people have sufficient expertise to advance their own
interests in a complicated international trading environment.

And, I don\'t pretend that that\'s an easy, you know, thing for anyone
to do and that the disparity and the resources between, say, the poorest
countries and the richest, you know, makes it almost quixotic, but, I
mean, to me I\'m not signing on to, you know, let\'s give them more
money so that they can all learn how to say yes.

And I think that that is somewhat the thrust of some of our capacity
building. What appeals to me about this is that we would be providing
people with a cadre of, you know, highly trained folks in these issues
with respect in their own countries who can help them make their own
decisions.

MS. SULTON: We\'ve gotten a lot of discussion around this so that we can
possibly begin to rewrite it and we have two more cards up and I remind
you, it\'s almost 11:30 and we\'re on issue 4 of 28.

DR. BUSS: I was just going to suggest a rewording of the topic segment
that would read so that its current wording would read the poorest
developing countries lack capacity to address scientific, intellectual
property, regulatory and international negotiation requirements related
to biotechnology period. Delete the rest.

MS. SULTON: Jerry?

MR. SLOCUM: The point I think that hasn\'t been made that we ought to
make when we rewrite this thing, when you guys rewrite it, is that these
people are going to put in some kind of safety and regulatory regimes.
And we talk about these international regulatory systems it scares the
life out of me.

But, certainly the people that, like these national systems in Togo, I
think was the example used this morning, need to be qualified to do
that. And if that\'s not part of our role and part of the western
European role I don\'t know what is. It\'s part of the Chinese role. So,
I think that there needs to be a U.S. effort at capacity building and,
yet, ought to be sponsored in part by the Chinese and the Indians and
whoever\'s going to export to them, eventually export to them.

Because though we don\'t import today, they\'re going to be players in
these international regulatory schemes or whatever those things are.

MS. SULTON: Lisa?

MS. ZANNONI: I just have a minor thing. Could we change poorest to least
because internationally the classification is least developing
countries. It just kind of \-- poorest just seems a little bit \--

DR. JAFFE: I mean, I know you want to move on, but, I\'d like to at
least have summary of what is going to try and go back and be written
about this because it\'s not clear to me.

MS. SULTON: Well, as I understand it, it\'s just a statement that the
capacity is not there and that the future in the sense that they will be
importing \-- coming up to the question of importing biotech and they
need to be prepared to answer those questions. Daryl?

DR. BUSS: Actually, I was going to say suggest that Jerry\'s statement
that appeals to the concept, he makes an excellent point for a
discussion. Countries need to develop their own safety and regulatory
systems and then yet questions arise regarding new biotechnology
products. You know, I think that logically flows into the next sentence.

MS. SULTON: Do you have \--

DR. LAYTON: It\'s there.

MS. SULTON: It\'s above?

DR. LAYTON: No, I think the concept is there.

DR. BUSS: As opposed to the concept.

MS. SULTON: Okay. As I said, is that concept there?

DR. LAYTON: So, I had to integrate with international efforts and I
think there\'s a concept too. Is there any more concepts?

MS. SULTON: Greg and then Duane?

MR. GRANT: It is an important issue because they\'re not just importers.
These developing countries are exporters of some products. Thailand, for
example, is, I think, the second largest shipper/exporter of sugarcane
for export, yet they don\'t have the capacity to adequately regulate
within their own country and we\'re going to ask them to meet our
standards. They\'ve got to know how to meet our standards if they\'re
going to move into the world market.

MS. TUCKER FOREMAN: Well, that\'s their obligation, not ours.

DR. LAYTON: I don\'t think that what\'s up here doesn\'t say that now,
the way we fixed it. Okay.

DR. JAFFE: I would just say that I mean, I think one of the problems
with this was that, whoever\'s going to write this up, I mean, it was
trying in some ways to do too much and I would sort of tone it down to
do less. In particular, I mean, what I hear Jerry talking about is
really regulatory systems and safety stuff. But, getting into
intellectual property and international negotiation skills is one issue
I\'m not sure that this was trying to do too much there.

And the second comment I would give is I was uncomfortable with some of
\-- in the detailed discussion about scientists and lawyers and legal
training and regulatory training and expert technological expertise.
These are very different areas and to sort of bunch them all together,
especially capacity building, I think is problematic as I\'d just sort
of say stick to what we really want to do here, but, some of the
language that was in the details I know we\'re not going to take it,
but, it was sort of confusing things about legal versus scientific and
also public spokesmen versus people who are helping to write regulatory
systems.

MS. SULTON: All right.

MR. DEMORGAN: I just added don\'t go too broad in the current language.

DR. LAYTON: Next.

MS. TUCKER FOREMAN: I did hear a few people talk about the use of
international efforts in this.

DR. LAYTON: Yes. I made a note, integrate international efforts.

MS. TUCKER FOREMAN: And the role of industry.

DR. LAYTON: And she\'s got it at the \--

MS. TUCKER FOREMAN: Okay. Thank you.

MS. SULTON: All right. Topic 5. The adoption of agricultural
biotechnology domestically and globally have had and may increasingly
have important impacts on crop production patterns. The extent and
degree of adoption of biotechnology in certain crops and plant species
will impact the producers and the U.S. agricultural production patterns.

DR. LAYTON: And modern should probably be prefaced saying biotechnology.

DR. SCHECHTMAN: We\'ll fix all that.

DR. LAYTON: I was just going to say and don\'t worry about that.

MS. SULTON: Any comments on this change from Greg? We\'re talking about
USDA should be aware of the effect of the changes domestically.

DR. JAFFE: My comment was only to the last sentence and the discussion.
I have no problem with this.

MS. SULTON: No problem with the statement?

DR. JAFFE: No problem with the statement except for, again, I think we
need to put what you\'re talking about and the definitions being
correct. It was the last one that sort of said it, that it\'s important
for USDA to be aware of international market access and the competitive
implications of these changes. But, I didn\'t know why we were focusing
on that. I think that it\'s important for them to understand the
domestic impacts of people getting more Roundup Ready^®^ soybeans or GE
papayas in Hawaii or things like that.

And, so, I was uncomfortable with the last statement which suggested the
primary focus here was international.

DR. LAYTON: So we can actually just take out the word international and
it means any market access issues and competitiveness be they domestic
or foreign. Is that okay? MS. SULTON: Does everyone agree to this
statement pretty much captures our context? Okay. Shall we go to 6. It
has to do with funding of research. Funding for agricultural
biotechnology research has a direct impact on agricultural policies and
which biotechnology derived crops get commercialized impact where
scientists gravitate.

In the comments from Alison where she\'s raising some questions about
how direct that impact is on policy, the impact of research is on
policy.

DR. VAN EENENNAAM: Yeah, I guess I just didn\'t understand how funding
for biotech research has direct impact on any policy.

MS. SULTON: And then Carol provided some language again, some suggested
rewrites. And Mardi also had some questions in here. Talking about what
drives the private sector with the profitability and the issue of the
government focusing on public issues. Duane and then Greg. Looking at
the statement.

MR. GRANT: Yeah, the statement. It seems to me that actually it\'s USDA
policy that has a direct impact on agricultural technology research
versus the other way around.

MS. SULTON: Greg and then Carol.

DR. JAFFE: I don\'t agree with Alison\'s comment. I don\'t think funding
has a direct impact on funding of agriculture. Agricultural advisory
research (sic) has a direct impact on everyone. Perhaps that\'s too
broad a statement. And similarly, I think one of the problems with the
write-up here is we seem to be mixing up private and public and
agricultural research funding in general and biotech research funding in
particular and I think we\'re trying to mix a bunch of apples and
oranges in the whole topic which made it difficult to understand or
comment on.

MS. SULTON: I was thinking back to the presentations we had on research
and we may have jumbled them in here.

MR. DEMORGAN: So, what\'s this change, Alison, you think you\'d
recommend in terms of the discussion of the topic like that?

DR. VAN EENENNAAM: I guess you could just, funding for agricultural
biotechnology has a direct impact on which biotech derived crops get
commercialized and I\'m not sure, are we arguing here that we want to
have more public funding to develop genetically engineered crops? I\'m
not sure that everybody in the room would agree on that.

MR. DEMORGAN: I\'m sorry. I didn\'t quite \--

DR. VAN EENENNAAM: Just that I don\'t think it has \-- just take out, it
has a direct impact on agricultural policy, because I don\'t think
that\'s true and then I think the rest of it\'s going to depend on what
the discussion says as to how to separate out the private/public
discussion before we make that determination.

MS. SULTON: Carol Tucker Foreman and then Carole Cramer.

MS. TUCKER FOREMAN: I think Daryl was going with the suggestion you
made, Alison, we might be getting there. I think without making a
recommendation, which I think that last sentence probably is, no, it\'s
not really, I think there should be more public funding for agricultural
research because it has been static over the last ten or so years.

As Pat and I have discussed, I\'ve been eager to see that go in the
direction of competitive grants and away from formula funding and I
think the competitive grants is the issue that is keeping the money from
going to the minor crops, isn\'t it?

DR. LAYTON: Absolutely.

MS. TUCKER FOREMAN: So, I know that Michael raised that. Again, if we
can be in favor for agricultural research I can get along there and I
thought Daryl was getting pretty close to something I could go with.

DR. LAYTON: Yeah, I think Daryl was a lot closer than what we have
already.

MS. SULTON: Mardi\'s card\'s up.

DR. MELLON: Well, I just \-- I mean, I think this is just a huge issue
and probably a difficult one to encapsulate, but, it is \-- you know \--
it is that our whole \-- we\'re not funding \-- we\'re not using public
monies to fund ag research. We\'re depending, you know, on companies to
do it, on the prospect of profits to kind of drive the choice of
research projects. We\'re turning our agricultural research universities
basically into industrial incubators, incubators for new products.

And I understand why people are doing that. I think it\'s just huge,
huge mistake because I think the big problems in agriculture are much
bigger than those that can be solved by new products, even though new
products are important. I think what we really need to address, the real
big problems of agriculture will be \-- I\'ll just, you know, say
systems, being able to think about how we should address our systems so
that it can accommodate global warming and new diseases; I mean, the
whole thing out there.

So, I do believe that this is big and I do think that one consequence of
this huge shift in the way we set priorities in ag research is that not
only get money for products, you only get money for big products and
that means you only get money for major crops because that\'s the only
place where you can really look forward to income stream that will drive
any sort of a research program.

I mean, there just ain\'t enough money in individual improvements of
lettuce to do it. So, I mean, so I would like to see us, you know, say
that there should be more public funding; that it should be \-- but, I
would like to see it have a broader set of potential applications other
than just new products. I wouldn\'t stand in the way of the notion that,
you know, that a broad public focus to our broad ag research would be
that you get more money to do appropriate biotech in minor crops. I
think that that\'s one thing that you might get out of a different
priority setting mechanism.

But, I actually think you get much, much more. You get much more money
looking at traditional breeding, marker-assisted breeding, these new
mixed-up systems that are going to have a little biotech and a lot of
marker-assisted breeding and a lot of traditional breeding. You know,
that, to me, would be a big deal. So, I\'m not opposed, you know, to
have it kind of written the way Daryl did, but, I still think it\'s too
narrow.

We want some recognition that we need \-- that our research
establishment needs to do more than just be an incubator for new
products.

MS. SULTON: Carole?

DR. CRAMER: I guess I still don\'t think we have a clear statement of
the issues, but, in fact, even if you\'re talking about your most
traditional approach ultimately the only way that research can have an
impact on agriculture is through the production of a product. It may be
a new seed line, a new variety that\'s developed to be fusarium
resistant but by traditional methods. But, in general, your research is
either understanding where to control disease so \--

DR. MELLON: No, I really fundamentally disagree. I mean, I think that
you want to look at \-- if your problem is how do you control weeds or
pests, one response is a pesticide. Another response is the system, is
the way you choose to grow crops together, one after another now. If you
just \-- you know \-- if you rotate your crops, for example, you can
control pests. That\'s a systems approach that solves the problem that
doesn\'t involve a product.

That kind of thinking is not being done except in the most narrow way in
a lot of \-- in the USDA today and it is \-- I think it\'s just a huge,
you know, strategic mistake for us to not be thinking about the system
as a whole.

So, I do think you need the products too. I\'m pro-product, but, I am
just not for this kind of \-- you know \-- every solution to our
problems is products but I really don\'t think it is.

MS. SULTON: Pat and then Greg.

DR. LAYTON: I understand that it is hard for some of you to understand
research\'s impact on policy, but, I do think it is there. And I\'m
going to \-- because policy may be that we actually \-- I think it is
serendipitous that we have a policy that allows us to have papaya
production in Hawaii; that we actually cure a disease by a competitive
grant to just figure out how to stick genes into something; that we
actually have a crop that grows in Hawaii. We wouldn\'t have that. So,
that has to do with, you know, a lot of other things.

And there have been some other times. So, while I\'m okay that you
don\'t want to say it has a direct impact on agricultural policy it is
linked to ag policy and I don\'t know how to get that back into this. I
just don\'t want to lose, totally, policy out of all this. I\'m going
back to that policy issue. I don\'t know how to do that. It may be that
it\'s down in the write-up and not out and maybe I missed it. I just
want to make sure we didn\'t totally take it out.

MS. SULTON: Does anybody want to speak to this policy thing before we go
\-- wait a minute.

DR. VAN EENENNAAM: Yeah, I guess how does the papaya affect that policy,
the example?

DR. LAYTON: I think it would have \-- I want to think about it. I just
don\'t want to abandon it without thinking about it and having a
discussion on it. I don\'t want to abandon the policy stuff. I\'m
willing to \-- I\'m comfortable with taking it out of maybe topics, but,
I want to think about it, so, I\'m holding my statement here on \-- what
did Michael do yesterday, he didn\'t want to get rid of modern
biotechnology, I\'m not willing to get rid of policy yet without having
another discussion.

So, I want to hold my powder here.

DR. JAFFE: Just to that, I have another comment. Just to that, I mean, I
think the problem was that the absolute nature of funding \--

DR. LAYTON: I agree. I agree. And I\'m \--

DR. JAFFE: \-- has a direct impact on funding of products. You ought to
say funding for GE papayas has an impact on GE papaya agricultural
policy or something like that, papaya agricultural policy.

DR. LAYTON: I didn\'t say \--

DR. JAFFE: But, it\'s so broad is the problem.

DR. LAYTON: I\'m just not ready to agree to drop policy out.

MS. SULTON: We\'ll come back to the other point. Okay. Jerry and then
Bob. This is on policy?

MR. SLOCUM: This is on policy. And I\'m a recipient of agriculture
policy. I get payments from the federal government. We export grains and
that\'s regulated by federal policies and some agricultural, some not.
As those policies change it changes the need for agricultural research,
both basic agricultural research, systems research that Mardi talks
about because that is incredibly important, and the only place that\'s
going to be done is in public universities.

The only place it\'s going to be done there is public universities, so,
there is a linkage. It\'s not a direct linkage, but, as policies change,
as agriculture policy changes, as we move toward a more market-access
economy, etc., etc., etc. with respect to agriculture our research needs
are going to change. And I don\'t think agriculture research drives
policy changes, but, I do think policy changes has a great impact on
where agricultural research needs to be focused.

DR. LAYTON: That\'s why I wanted to hold my \--

MS. SULTON: Yeah, I think that\'s what Alison\'s point was originally,
was that policy affected research rather than research affected policy.

MR. GRANT: That\'s what I said at the beginning.

DR. LAYTON: And I wanted to make sure it wasn\'t totally dropped. Bob?

DR. HERDT: I think the idea is \-- let me just try a completely
different approach. I think what we\'re partly saying is commercial
companies provide most of the funding for agricultural biotechnology
research and the focus of that research is on large markets with little
attention to minor crops. Without appropriately directed publicly
supported modern biotechnology research on those crops they will slide
into a competitive disadvantage. I mean, it seems to me that that\'s
behind what these things are. Is it?

DR. LAYTON: Yes. To some extent.

DR. HERDT: Now, and Mardi has an additional point, I think, that not all
publicly supported research goes toward producing crop varieties. There
are lots of other kinds of research that can address needs of
agriculture. That\'s another point. I mean, are we trying to say that
here? Is that what we\'re doing?

MS. SULTON: Okay. You have a comment on that, Greg?

DR. JAFFE: Yes. I was trying to get back to what is the issue here and I
think that the issue is that \-- I mean, I think the problem is we\'ve
tried to discuss this in a much broader sense. We don\'t talk about
agricultural policy. We don\'t talk about agricultural funding in
general and the stagnation of it. I think we just get down to the bare
facts which is commercial companies work on \--

DR. LAYTON: Things they make money on.

DR. JAFFE: \-- they make big products which are commodity crops in the
biotech arena. The federal government is not spending very much money on
biotech research, especially for minor crops. If one wants minor crops
to benefit from agricultural biotechnology something needs to change. I
mean, that\'s the concept.

MS. SULTON: So, you\'re agreeing with Bob\'s language that the approach
is that. Does anybody have a additional point on this? Duane?

MR. GRANT: Yeah. So I think that I don\'t disagree with that rendition.
I think that\'s an accurate rendition of an issue. I don\'t think that
gets to the issue of the link between policy and research.

DR. LAYTON: But, that would solve my issue which is why these whole
issues in here is frankly to get minor crops and trees than what it
originally says and research so I\'m happy.

DR. HERDT: Your point is another point.

MS. SULTON: Okay. Michael? Michael first and then Michael.

DR. DYKES: I think the other \-- when we originally discussed this, I
think that going along with what Mardi was saying, I think this also
ties into what the statement that Mardi and Carole prepared yesterday.
What this was talking about was it will cause other things to happen
once there\'s funding, research brought into it.

DR. LAYTON: That rich milieu.

DR. DYKES: The milieu deal is a part of this conversation as well.

MS. SULTON: All right. Michael?

DR. SCHECHTMAN: Just before we move on from this topic I wanted just to
mention something that I think is probably relevant to this committee
but is not \-- but is related to the subject of this issue but is not
the issue itself and that is that USDA has an initiative that\'s been
going on, to talk about how to support the regulatory process for work
that\'s done in minor crops and there\'s actually going to be a workshop
in the Washington area on November 21st and 22nd for a
university-government consortium that\'s talking about this issue.

So, if people are interested in it it\'s something that I can get you
information on and I will send it out to the whole committee. But, I
just wanted to make note of it.

MS. SULTON: Okay. Noting that and moving on. Go ahead, yes?

MR. DEMORGAN: Could I just ask, so Bob\'s statement is a concept that
needs to be in here or is it a replacement?

DR. LAYTON: It\'s a replacement.

DR. HERDT: It\'s a replacement for the topics sentence.

MR. DEMORGAN: And that doesn\'t anymore address Duane\'s question of a
linkage between research and policy?

DR. HERDT: It is gone. My understanding of what this really is meant to
address, I don\'t know how a direct impact on ag policy got into the
topic sentence \--

DR. LAYTON: I don\'t either.

DR. HERDT: \-- because it just doesn\'t fit. It doesn\'t fit, I don\'t
know, some \--

DR. LAYTON: It was a wild hare in a phone call but I\'m okay with that.
I\'m okay with that.

MR. DEMORGAN: Okay.

MS. TUCKER FOREMAN: I would like to \-- I liked Greg\'s last set of \--
Bob, while you were up working with Paul, Greg had a close, but,
slightly different statement and would you \-- have you got it written
down?

DR. JAFFE: I didn\'t write it down, but, it\'s something to the effect
of, you know, if \-- I mean, I sort of did it as a three statement kind
of thing. The first statement says that the commercial companies are
funding biotech research primarily in commodity crops. And the federal
government is just not funding a lot of biotech research, especially in
minor crops. And then the third sentence is if one wants minor crops to
gain any benefit, to benefit from the advantages of genetic engineering,
that system needs to change.

DR. LAYTON: The rich milieu.

DR. JAFFE: Something needs to change, you know, in that so it gives you
that idea. You\'re not saying that

\-- you\'re saying if you think or if you want to derive a benefit from
this technology.

DR. HERDT: Right, right, that\'s better. I mean, I used competitive
disadvantage. That\'s good.

DR. SCHECHTMAN: Are you feeling that another sentence is needed to talk
about \--

DR. MELLON: I\'m just not \-- I want at least another place to talk
about, you know, a broader issue of research funding or some notion that
this is one of the many, you know, problems of \-- that might be facing
public funding.

MS. SULTON: So the contextual statement sentence in that detail speak to
that?

DR. MELLON: Well, I just \-- it\'s just such a big issue, but, I guess I
don\'t like \-- I just don\'t want to leave the people with the
impression that that\'s the big problem is that we need to use our
limited public funding to do minor crops, you know, in the U.S., that
that is a major kind of need. It may be. Forestry, actually, I would go
along with. I mean, that feels a lot better to me.

I think somehow we have to get into why it is that the companies don\'t
want to invest money in minor crops is because minor crops already do
what they need to do; that there isn\'t enough value in this expensive
kind of control technology for anybody to be willing to pay for it.

MS. SULTON: Well, we actually made note of that concept so that when the
rewrite is done \--

DR. MELLON: I will just do what Patricia did which is to reserve a
little powder.

MS. TUCKER FOREMAN: I think the problem is that having Mardi\'s concept
led by the minor crops issue is the gnat leading the elephant.

MR. DEMORGAN: What I added was this could be a new issue. I mean, it
sounds like \--

MS. TUCKER FOREMAN: Okay. But, \--

MR. DEMORGAN: But, Mardi, you\'re saying \--

DR. MELLON: Right, and I wrote, you know, a provocative probably too
strong a statement of kind of some of my concerns in this little
paragraph and maybe they would be another \--

MS. SULTON: So you might put a note here to see Mardi\'s comment.

DR. MELLON: Yes, and we could try to maybe do that and do something
about this idea of all of these things working together to me is much
more beneficial to our agriculture than just focusing on these crops.

DR. LAYTON: Okay. We\'re going to continue to work on this one. Let\'s
try to get one more in.

MS. SULTON: All right. Number 7. One of the keys for the future of
biotechnology is to focus an objective documentation of the impacts of
agricultural biotechnology products, including soil use, pesticide use,
and other environmental impacts. And we have contributions from Alison,
Daryl, and Greg. Daryl actually provides \--

DR. LAYTON: A rewrite.

MS. SULTON: \-- a rewrite. And, Alison, we\'re going to table this,
whether we lump it. And then Greg raises the question whether this topic
should be limited to environmental impact and, if not, we should
identify the range of impact.

DR. LAYTON: Is that about the modern biotechnology question? Is that the
issue, Greg? I\'m asking.

DR. JAFFE: No. I mean, the issue is that \-- I mean, I think I\'m all
for documenting the impacts of genetic engineering and genetic
engineering products, whatever you want to call them. It\'s not that,
that wasn\'t the issue. But, let\'s call a spade a spade. Is this one
about just documenting the environmental impacts? If it is, let\'s just
say it up front, such as soil and pesticide use.

If we\'re talking about a broader impact then we should use other
examples than just those and I was giving some other examples. I\'m just
saying if the scope of this is environmental impacts I\'m comfortable
with that. But, I think we need it explicitively stated.

If the goal, if our idea is to broadly talk about the impacts then we
should talk about food impacts, impacts on farmers in the Midwest, other
kinds of things, we should say that we want to have a research agenda
that looks at more probative impacts. We want a broad statement.

It\'s a key to future of the biotechnology. One of the keys to the
future of biotechnology. But, I would \-- that was sort of my concern is
whether or not all these examples are environmental, are we just
limiting it to that.

MS. SULTON: Carole, did you want your card up again?

DR. CRAMER: I\'ll leave it down for a minute.

MS. SULTON: Russell.

MR. KREMER: Yeah, a follow up on Greg\'s comments that I agree. I looked
through this thing and noticed that really this is the only place that
talks about impacts and I\'d like to see it more inclusive. I mean,
basically, not only does it, I think, directing it basically toward
environmental impacts, but, also just toward crops. You\'re talking
about soil loss and pesticide use. And, so, I guess I would be in favor
of expanding the whole \-- looking at the impacts of agricultural
biotechnology to include such things as economic impacts.

I mean, there\'s no place in here that I\'ve seen anything that talks
about, you know, does this stuff actually pays for farmers, pay farmers
to do this. And, so, I would like to expand it to agriculture, economic
and social impacts as well as dietary issues.

DR. LAYTON: Okay. Can we expand or not expand? Michael?

DR. DYKES: Help me understand the dietary impact.

MS. SULTON: How you would measure them?

DR. DYKES: Yeah, and how you measure them.

DR. VAN EENENNAAM: You missed one back here.

DR. DYKES: I don\'t know what that is.

MS. SULTON: Well, Greg wrote it.

DR. LAYTON: Greg wrote it.

DR. JAFFE: I\'m not somebody who idolizes impacts on some things. I\'m
the wrong person to say this, but, clearly, if Roundup Ready^®^ soybeans
are really working very well and they\'re planting a lot of soybeans and
we\'re changing the amount of soybeans in our diet from corn in our diet
there might be dietary impacts because of the amount of soybeans people
eat and, therefore, you know, the levels of whatever the isoflavones are
in soybeans or impact on those ingredients in the products. I mean, I\'m
not doing this as a design for a study here.

My point is that over time biotech crops may impact what is grown, what
isn\'t grown, the amount of wheat is grown versus the amount of soybeans
and corn that are grown, the amount of cornstarch that is used. I don\'t
know what they are. I was just broadening this to sort of say, I don\'t
want to use that one as a specific example, but, that we should be
looking at the range of impacts and those could be dietary impacts. It
could be economic, social, movements of rural populations. I don\'t know
what they are.

DR. DYKES: I didn\'t mean to put anybody on the spot, I just don\'t
understand when we say we\'re going to measure dietary impacts. I was
just trying to understand what you mean by that.

DR. JAFFE: Right. I\'m giving you an example. We now substitute soybean
for corn or soybean for wheat in lots of products and it might have a
dietary impact, it might not.

MS. SULTON: Carol?

MR. SLOCUM: I\'m certainly not opposed to whatever biotech crops impact
as long as it is objective documentation. And I think that was the point
that we made when we put this item on the table several months ago. We
wanted to be able to measure what we talked about here, analytically
measure it and point to it and say this is an impact.

MS. SULTON: Carol?

MS. TUCKER FOREMAN: Yeah. I agree with Jerry that the thrust of this is
that we need an analysis of the effects about these products and it
should be as broadly stated.

MR. SLOCUM: It should be as broad as it should be.

MS. SULTON: Ron?

MR. OLSON: I would just like \-- I mean, you\'re not the right guy to
make the example and I\'m not either probably, but, the reasons soybeans
are being used more is there\'s a health claim on soybeans and there
isn\'t one on wheat so it has nothing to do with biotech. So, I mean, I
think, and I go back to what Jerry said. It has to be objective and say
there\'s a link here rather than is there a direct impact. I would say
there probably isn\'t, but, I think there are crop shifts that belong
for various reasons and they\'re driven by things that aren\'t
necessarily biotech.

MS. TUCKER FOREMAN: And we\'d want to know that.

MR. OLSON: Yeah, and that\'s what we need to point out.

MR. DEMORGAN: So if you just did this, what was on the screen, which is
the effects on social impacts, the last part, going with Greg and
everyone else so far would say.

DR. JAFFE: I would probably just take all that out and the topic
sentence and have a sentence in the body talking about as examples as
opposed to putting it there, but, \--

MR. DEMORGAN: Putting what where?

DR. JAFFE: I would just sort of say the impacts of, I don\'t know if
they\'re biotechnology products, not for economic, social, environmental
in the topic sentence. I would then have a sentence in the body that
said we included the kinds of impacts one might be looking at would be
environmental impacts such as soil loss, other kinds of soil, you know,
whatever. I don\'t know what would go in the sentence.

DR. LAYTON: Are you guys comfortable if we switch that sentence around
the way Daryl did?

UNIDENTIFIED MALE: I like Daryl\'s.

DR. LAYTON: I like Daryl\'s. We can say key to the future is important
might be good enough, but, I just wanted to ask.

DR. DYKES: This is what the discussion was last time.

DR. LAYTON: Yes.

DR. JAFFE: Just wordsmithing it here. I don\'t know what effective
documentation is. I mean, I know what objective documentation is. I
don\'t understand what effective documentation is.

DR. LAYTON: I\'ll tell you what it is. Can people read it, get a hold of
it, and have access to it. That\'s effective.

DR. JAFFE: I\'m not sure it\'s \--

DR. LAYTON: Effective means it\'s available.

MS. TUCKER FOREMAN: Put that\'s understandable there.

DR. LAYTON: How about that\'s available.

DR. JAFFE: I\'m not sure it\'s \--

MR. SLOCUM: Well, that describes it as fair, unbiased, understandable,
and factual.

DR. LAYTON: I like that.

MS. SULTON: Mardi and then Bob. We\'re going to take Daryl\'s.

DR. MELLON: I would just \-- conceptually I don\'t \-- I mean, one of
the things I thought we talked about in our discussion was how important
it is for the USDA, especially the ERS, to collect the kind of data on
which the analyses can be done.

If we\'re going to know you want to find out the effects on farmers,
their incomes, and then you\'ve got to have people collecting that kind
of data and USDA is uniquely situated to collect the raw data on which
the analysis is done and, so, I just want to \-- that is the message I
would like to send to the Secretary is it\'s worthwhile collecting that
robust set of \-- several sets of data on which these kinds of analyses
can be done later on because they\'ll always be tough and a lot of
people can use the analysis.

MS. SULTON: And you\'re describing the collecting of the data to the
USDA\'s unique role.

DR. SCHECHTMAN: USDA has the data and \--

DR. MELLON: And you\'re deriving information from all of these folks and
that\'s got to be objective. All of us have to be able to believe in it
whether we use it to answer questions.

MS. SULTON: Bob?

DR. HERDT: Yeah. I would agree, it\'s impossible, that is, that you can
have effective and objective documentation of use, but, I think you have
to \-- if you want to know the impact, you have to do research. You
can\'t just document impact. I think, you know, impact is \-- you\'re
talking now about complicated things. You\'re talking about economic
impact, you\'re talking about dietary impact, you\'re talking about
these things. You\'ve got to have research in there.

You cannot just say, you know, collect the data and document the impact.
So, I think we need to have the word research in there.

DR. SCHECHTMAN: Put analyze there.

DR. HERDT: Analyze is in the \-- next to the last \--

DR. LAYTON: It is essential to the resources to collect, analyze, and
disseminate.

DR. HERDT: I would say effective and objective documentation for use and
research on the impacts. But, anyway, I mean, understanding impact is
going to be complicated, so, don\'t say, you know, document it.

DR. LAYTON: But, I\'m adding research as an aid.

MR. DEMORGAN: In the topic?

DR. LAYTON: In the write-up.

MR. DEMORGAN: Well, I just put Daryl\'s paragraph here.

MS. SULTON: Just say, maybe put a concept in there that we need to make
sure that we focus on the \-- maybe elaborate on the analysis to include
the complexion of research.

Bernice and then Greg.

DR. SLUTSKY: I guess I was going to make some of the points that Bob has
made in terms of what, in fact, we\'re asking USDA or recommending USDA
do because we\'re talking about a wide range of impacts here and you
also mentioned ERS. I think it\'s not \-- I mean, this is very
complicated and I\'m not quite sure what \-- you know \-- there\'s some
areas that USDA can do more effectively than other areas and it\'s not a
matter of going out and looking at data and the different things about
the dietary effects. I mean, that, in and of itself, is, you know, well
beyond what ERS does and could, you know, in terms of being able to
analyze that kind of data.

That\'s really research in my view.

DR. DYKES: Well, we still have the dietary effects on \--

DR. LAYTON: It\'s gone.

MS. SULTON: It\'s gone. Okay. Greg?

DR. SLUTSKY: My point still stands. It may be research, for example, you
know.

MS. SULTON: Greg, Bob, and then Alison.

DR. JAFFE: And I think Mardi got a little bit into it and Bernice, the
same thing. I read the sentences below the topic sentence and it\'s not
clear to me what \-- where we\'re differentiating. We\'re asking USDA to
play a dissemination role or actually asking them to play a collection,
analyst, and research role, and I don\'t see a statement about who else
is going to be doing this.

So, I\'d like something in those two sentences to sort of say that, you
know, that the government has some role in this, but, that there are
other, whether public researchers or others, also have a role. I mean,
we sort of say encouraging peer review, analysis, and information. I
guess that\'s the information that USDA does, but, we\'ve mixed a lot of
things in those two sentences.

I\'d like to sort of get in there that we\'re asking for independent
public researchers to identify and analyze and research the impacts and
I guess what we\'re asking at some point, we\'re talking about USDA
doing some of that, but, also I think part of it is the question for a
dissemination role for USDA.

MS. SULTON: Okay. Bob?

DR. HERDT: I guess I would just put another vote to put research in the
topic sentence.

MS. SULTON: Okay.

DR. LAYTON: Would it be the effective and objective documentation of
research?

DR. HERDT: Research on impacts.

DR. LAYTON: Research on impacts.

DR. HERDT: It\'s research on impacts.

DR. BUSS: Or you could say research to effectively and objectively
document impacts.

MS. SULTON: Say that again, Daryl.

DR. LAYTON: Daryl was good.

DR. BUSS: Research to effectively and objectively document the impacts
and the rest of the sentence.

MS. SULTON: Alison?

DR. VAN EENENNAAM: I think what drove this topic originally was that it
was intended that the USDA would do that research. The data\'s available
there now and independent researchers have interpreted it in several
different ways and, so, I think the thought is that USDA is the same as,
you know, not being paid by anybody and that they have the unique role
in actually researching and documenting what the impacts are that will
be believed by the general public more than it will of studies sponsored
by this group or that group, even looking at the same data.

DR. SLUTSKY: I guess I would just say it would depend on what impact
you\'re talking about USDA was \--

DR. VAN EENENNAAM: Well, I mean \--

DR. SLUTSKY: \-- than other \--

DR. VAN EENENNAAM: Well, on a really base level, you know, just, you
know, has it increased or decreased pesticide use. You know, that should
be a slam dunk. But, that one should be a slam dunk to do.

MS. SULTON: Carol?

MS. TUCKER FOREMAN: I just want to flag it because this is another place
where we\'ve got hidden in here by \-- in other language a
recommendation and I don\'t think we need to take it out, but, I think
we\'ll have to go through it at some point and flag all the things where
we\'ve actually got an action sentence there so that at the end we know.

DR. LAYTON: What I can do is try to bold or to italicize any action
statements that might be questionable so that someone can suggest some
alternative ones.

MS. TUCKER FOREMAN: No, I\'m not saying \-- I think in the end, you
raised it earlier today, that everybody agrees that I think in the end
we may agree that there is some things that it\'s okay to have action
sentences about. But, I think in the end we probably want to look at the
list of what that is and \--

DR. LAYTON: Okay. So, action sentences should be italicized for review.
Okay?

MS. TUCKER FOREMAN: Thanks.

MS. SULTON: I just want to make sure I\'m clear that we\'re now talking
about collecting \-- we\'re talking about doing research. Are we also
taking about dissemination of results in this?

DR. LAYTON: Yes. You\'ve got to do \-- if you do research you\'ve got to
disseminate the results.

MS. SULTON: Okay. Anything \-- Ron?

MR. OLSON: We also have the use of research. I think one thing we\'re
saying we want the USDA to give us the actual facts that they know. They
give us acres planted, those kinds of things, pesticide usage. There are
some things out just on the use of these things that are valuable
because people use different \-- people outside will say, well pesticide
use is skyrocketing. Others will say, well, it\'s gone down.

DR. LAYTON: So, document use and research impacts.

DR. HERDT: That\'s always going to happen.

MR. OLSON: Oh, I know, but, \--

DR. HERDT: How are you going to ask USDA to prevent that? You know,
it\'s nice to have the USDA choose the county. Come on.

MR. OLSON: It\'s kind of like having the USDA crop report. There\'s
twenty others out that have a crop report but it\'s nice having one that
everybody can look at.

MS. SULTON: So you want some statistical input. Alright. I think we have
enough to work with on this particular topic. It is five minutes after
twelve. So, lunch. So, do you think we\'re going to be right here in the
building we can limit it to an hour and be back here by one.

(Whereupon, a luncheon recess was taken at 12:11 p.m.)

[A F T E R N O O N S E S S I O N]{.underline} 1:12 p.m.

MR. DEMORGAN: Okay. So, we\'re going to try to keep moving forward.
We\'re going to take the last two of what were called new topics. I
think the presumption is that after today it will be just one list of
topics, but, the list of new topics and then we\'ll transition into the
current or however you want to characterize them. But, we\'re on number
8, which is listed up here. It\'s at the bottom of the third to the last
page.

It starts with government policy on alternative energy sources and the
need for energy will drive changes of agricultural production. We had
comments from Alison on this, including some proposed edits; Daryl and
I\'m not sure \--

DR. LAYTON: Josephine.

MR. DEMORGAN: Oh, Josephine. Good. Thank you.

DR. LAYTON: The issue is not commenting upon itself, correct?

DR. LAYTON: So any questions about the topic statement itself? Greg?

DR. JAFFE: I guess, just generally, the comment is the topic is very
generic. It doesn\'t mention biotechnology or genetic engineering or
transgenics at all, so, I mean, it seems like when they want to put
something that relates it to the topic of this report \--

DR. LAYTON: So, comma including \--

DR. JAFFE: I\'m trying to understand the issue because then when it goes
down lower it says the tools of biotechnology, and I guess, for me,
again, our report is just not on biotechnology and I didn\'t know what
to replace in there. Is it tools of genetic engineering that are being
employed to change oil and starch and so forth, but, \--

DR. LAYTON: Okay.

DR. JAFFE: \-- I don\'t have language, but, that\'s just a general
comment.

DR. LAYTON: Okay. Got it. I\'ll take care of it.

MR. DEMORGAN: And it looks like the paragraph itself does speak to what
you\'re saying so it\'s just a matter of making the topic sentence
related. Josephine?

DR. HUNT: My comment just refers to the fact that if we\'re looking at
global implications and we\'re looking at food products and non-food
uses we need to be ensuring safety of food and it\'s nowhere the wording
that we\'ve got, I know you haven\'t gone through that in detail yet,
when we talk about pharmaceuticals.

MR. DEMORGAN: Okay. So, your language though is to be putting the
descriptions?

DR. HUNT: I\'ve given the suggestion.

MR. DEMORGAN: Not as the topic statement

though \--

DR. HUNT: No, no, no.

MR. DEMORGAN: \-- as the description?

DR. HUNT: No.

MR. DEMORGAN: So, any thoughts about Josephine\'s suggested language?

DR. DYKES: Could you repeat that?

MR. DEMORGAN: It\'s right here. It\'s in your notes.

DR. HUNT: It\'s at the end of the section there. It was just we\'re
talking about applications and we\'re talking about use of food crops.
There needs to be considerations of safety too.

DR. VAN EENENNAAM: Does that kind of argue against the last sentence as
written that says future uses of non-food crops might lessen AP related
food concerns?

DR. HUNT: I don\'t think it contradicts it. My statement refers to the
end, food crops.

DR. LAYTON: You\'re saying it takes the place of the one that\'s right
above that one?

DR. HUNT: It starts here, if more.

DR. LAYTON: If more novel applications.

MR. DEMORGAN: So it\'s a suggestion, not as an addition, but, to replace
that sentence?

DR. LAYTON: Yeah.

DR. HUNT: Yes.

DR. LAYTON: Yeah.

DR. HUNT: Or use red line next time.

DR. LAYTON: No, it\'s okay. Actually it was red

\-- Josephine, I think yours were red, but, this was printed in black
and white. Somebody\'s in all of their edits were red. Okay. It was
Alison. Never mind.

DR. DYKES: Are we agreeing with the topic sentence?

MR. DEMORGAN: I think what Greg had noted was that we need to make it a
little bit more specific about technology, but, otherwise yes. Duane?

MR. GRANT: Mine is to a little bit different subject.

MR. DEMORGAN: Let me just \-- so, Michael, is that okay in terms of the
topic statement?

DR. DYKES: Well, I mean, yeah. Are we going to deal with that now? Are
we going to leave that aside? I thought we\'d probably go kind of get
the topics in before we want to do it and then we\'re going to go
through and get to these other sentences. So, to me, it makes more sense
to go through and modify the body if we don\'t know what the topic is.

MR. DEMORGAN: Sure, so Greg said he didn\'t have a specific suggestion.
Does anybody have a specific suggestion for the topic sentence that
would bring in the biotechnology aspect of this?

DR. LAYTON: My thought was could you put comma including modern
biotechnology at the end of the sentence, but, I\'m not sure that\'s
appropriate.

MR. DEMORGAN: Ron?

MR. OLSON: Yeah, it might just be that several \-- some of the changes
in the introduction, it might be a biotech-type crop that\'s at issue
there.

DR. LAYTON: Yes. That\'s what I was thinking, so, \--

MR. OLSON: So, I would put it before the changes in agricultural
biotech.

DR. LAYTON: Okay. So, government policy on alternative energy sources
and the need for energy will drive changes in modern biotechnology.

MR. OLSON: I don\'t know if it will drive the changes.

DR. JAFFE: How about \-- I mean, \-- sorry.

DR. DYKES: How about energy ag production may be addressed by \--

DR. JAFFE: Using. Government policy on alternative energy sources need
for energy \-- I\'m trying to say that the whole point of this is that
you\'re going to be using \-- will result in use of agriculture might
result in use of agricultural \--

DR. SCHECHTMAN: And the use of products derived from biotechnology.

DR. LAYTON: That\'s what I was trying to put in there.

DR. DYKES: Yeah, that\'s what I was going to do. I was going to do, and
modern biotechnology may provide some solutions or \--

DR. LAYTON: It\'s a need for energy will drive changes in agricultural
products and agricultural production and use of products of modern
biotechnology \-- of products from modern biotechnology.

DR. VAN EENENNAAM: I\'d almost turn that on its head and say that, you
know, genetically engineered crops may provide alternative energy
sources.

DR. LAYTON: Okay. I like that one. Okay. So \--

MR. DEMORGAN: Genetically engineered crops?

DR. LAYTON: Yes. Genetically engineered crops may provide alternative
energy sources.

DR. DYKES: In changes in agricultural production.

DR. LAYTON: And drive changes for in agricultural production. And the
need for energy derived changes?

DR. DYKES: Uh-hmm, yes. And the need for energy.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: Is may provide alter \-- may drive production
practices the most important thing you want to say there? First of all,
I think it would be good to use the examples that \-- a couple of
examples here, the change oil or starch content to energy production.
You don\'t have to say it in that sentence, but, it should be in the \--

DR. LAYTON: It\'s in the text.

DR. DYKES: I think the point is, is that biotech may have some impact on
energy needs. That\'s the basic concept coming out of that. The examples
Carol\'s pointing to are starch content and whatever the other one is
there. That\'s the follow-along sentence. To support \--

MR. DEMORGAN: Could you do something like genetically engineered crops
may provide alternative energy sources to help address the need for
increased \-- for an increased need for energy?

DR. VAN EENENNAAM: May provide sources for energy need or whatever.

DR. DYKES: To provide solutions to the increased energy needs.

DR. HERDT: Genetically engineered crops provide alternative energy
sources.

DR. LAYTON: That\'s it.

DR. HERDT: And drive changes in agricultural production. That\'s all you
need.

DR. LAYTON: Yes, that was it. That\'s sort of what we did in the
scenario thing. We talked about how it would drive changes in
production.

DR. VAN EENENNAAM: Is it the energy sources or genetically engineered
crops?

DR. LAYTON: Both.

DR. VAN EENENNAAM: What was driving changes in energy production?

UNIDENTIFIED MALE: Energy and the need for energy drives it.

DR. SCHECHTMAN: And the need \--

DR. VAN EENENNAAM: And this will. And this may. And this would.

DR. SCHECHTMAN: Their use may. The need for their use may.

DR. LAYTON: And their use may drive changes.

DR. CRAMER: So, I just thought there may be \-- what is the real issue?
There may be changes \-- there may be non-genetically engineered crops
that are used as fuels and also alter crop production patterns and as
you read it this seems to be completely linked. So, why don\'t we say
crops, including. The other thing is, you know, people have gotten to
buy solge grass (sic) and various other things that we couldn\'t call
crops per se. So, one thing we might say is, you know, agriculture may
provide blah, blah, blah including genetically engineered crops.

DR. SCHECHTMAN: Would it be something like their use may part of energy
driven changes \-- energy need driven changes in agricultural production
or something like that?

MR. DEMORGAN: Aren\'t you trying to do two things here? The first is,
you know, the need for energy is driving changes in agricultural
production. That\'s part one. Part two is ag biotech is going to help
agriculture more broadly respond to that need. And you\'re trying to put
it into two sentences it seems or one sentence and that\'s the
challenge.

DR. DYKES: I think the half that we have in the current sentence.

DR. LAYTON: Genetically engineered crops may provide alternative energy
sources.

DR. DYKES: Well, no, I was going back to the original sentence. I think
you\'re right. I think that\'s the issue. The sentence as originally
constructed has half of that. The need to drive agricultural production.
The ag biotech piece is not included in there.

DR. LAYTON: Okay.

MR. DEMORGAN: Okay. So, Carol are you on this?

DR. CRAMER: It changes all of that in there. I think all of what\'s up
there is mixing concepts and, in fact, as we seek more I believe that
I\'m approaching more confusion rather than less. As written here, as
gas prices go up we\'re driven to put less pesticide on because of the
cost for driving a tractor through. I don\'t think that\'s what we\'re
talking about, right? We\'re talking about the concept that with a push
toward biofuels there may be implications and the biofuels may be linked
both to genetic engineering and non-genetic engineering approaches.

And I think that\'s what we\'re addressing, right? Help me out, guys.
It\'s not \--

DR. DYKES: I think the first thing you\'re addressing is, is to follow
your discussions. As energy prices increase it will cause a shift in
production in agriculture, i.e., more corn\'s going to be produced for
ethanol than currently. Then the second piece of that, biotechnology may
play a role by increased oil or starch content or some of the others,
it\'s kind of a second aspect. It\'s not the total answer. Just plain
numbers of corn acres are going to shift probably because of energy.

Biotech will also be a part of it. Does that \--

DR. LAYTON: So it really is government policy on alternative energy
sources and the need for energy will drive changes in agricultural
production.

DR. DYKES: I think that\'s a true statement today. It already has.

MR. GRANT: It\'s not just government policy though. It\'s not just
government policy, it\'s the cost of energy.

DR. LAYTON: Okay. How about this. Alternative

\-- the need for alternative energy sources \--

DR. DYKES: Yeah, that may be the need for alternative energy sources
will drive changes in agricultural production.

DR. HERDT: Energy costs \-- energy demand will increase; genetically
engineered crops may provide alternative sources. Yeah, it\'s basically
what Michael said. Just put a semi-colon and you\'ve got one sentence.

DR. LAYTON: Okay. Okay. You all make sure she got it.

MR. DEMORGAN: So you struck policy. It\'s energy demands will increase;
genetically engineered crops may provide one source \-- one alternative
\--

DR. HERDT: One alternative.

DR. LAYTON: An alternative.

DR. HERDT: An alternative one source.

DR. LAYTON: Alternative energy sources. I don\'t know. Because it can be
more than one crop.

MR. DEMORGAN: May provide alternative \--

DR. LAYTON: Energy sources. Alternative sources of energy. And then we
talked about the oil and starch content, blah, blah, blah in there.
Okay. And the food, non-food uses, that kind of thing.

MR. DEMORGAN: And then strike the drive changes in agricultural stuff.
Period after energy.

MR. GRANT: Do you really want to strike that and drive changes?

DR. LAYTON: Because they will use less fuel and they will \-- you have
to less of some other chemical. Is it phosphorus that uses so much
energy?

MR. GRANT: Nitrogen.

DR. LAYTON: Nitrogen. That\'s it. I knew it was one of those.

MR. SLOCUM: Well, how are you going to explain coal production then?

MR. DEMORGAN: Alison?

DR. VAN EENENNAAM: How does this \-- I mean, crop production patterns
are going to change in respect to energy. Let\'s forget biofuel. That\'s
going to have some changes in production. That\'s not what we\'re
talking about here, is it?

DR. DYKES: Well, we\'re capturing that. That is happening.

DR. VAN EENENNAAM: Okay. I guess how does that relate to genetic
engineering?

DR. HUNT: It doesn\'t per se because the crops don\'t \-- \-- that\'s
the difference because the way it\'s reading there it says it\'s
genetically engineered crops that are going to then drive the changes in
agricultural production.

MR. DEMORGAN: But, Alison, I think, is suggesting that you do strike
that highlighted language.

DR. VAN EENENNAAM: Right, right.

MR. DEMORGAN: Jerry?

MR. SLOCUM: I think we first need to agree to the concept we\'re trying
to capture because we\'ve got about six of them on the table.

MR. DEMORGAN: What are the six then?

MR. SLOCUM: Well, I think I know the one though that we tried to capture
when we put this is that because of increased energy prices, because of
U.S. government\'s commitment toward biofuels \--

DR. LAYTON: National security issues.

MR. SLOCUM: \-- yeah \-- there may be a need for some genetically
engineered crops that address that new demand, that new demand for
biofuels.

MR. DEMORGAN: And that sentence, the first one, energy demands will
increase, provide a reason like you said. Genetically engineered crops
may provide alternative sources of energy to address those increased \--

MR. SLOCUM: I really think that probably I would say crops may be \--
may need to be genetically engineered to be more efficient as those
biofuel crops.

MR. DEMORGAN: Is that in the topic sentence statement or in the
paragraph that describes it in your mind?

MR. SLOCUM: It could be either place. But, I think \-- I really think we
had this discussion two months ago that was the concept we were after.

MR. DEMORGAN: So the concept being that you may need to do more
research, find more opportunities where GE crops can fulfill this need.

MR. SLOCUM: They may need to design GE crops to meet this demand.

MR. DEMORGAN: Right.

MR. SLOCUM: They may need to design new crops, whether it\'s through
traditional breeding or through genetically engineering to meet these
energy demands. Right now, you know, corn is not bred to be an energy
crop. Soybeans are not bred to be an energy crop. They\'re not bred to
be that way and, yet, that\'s the two major sources of our biofuel
program.

MR. DEMORGAN: Okay. So, could it be genetically engineered crops, either
existing or yet to be defined, and then you describe it further in the
discussion?

MR. SLOCUM: Okay.

MR. DEMORGAN: To get to your point.

MR. SLOCUM: Yeah.

MR. DEMORGAN: So strike that \--

MR. SLOCUM: We don\'t know that energy \-- honestly, we don\'t know that
energy demand will increase.

MR. DEMORGAN: Okay. So, Carol, are you up on this again?

DR. CRAMER: Isn\'t it if they stay at the level they are?

DR. DYKES: Jerry, I think the costs of that are going to increase.
Energy demands are going to increase. I think that\'s a true statement.

DR. LAYTON: Huh?

DR. DYKES: Energy demands are going to increase. Jerry was saying he
didn\'t know for sure if energy demands are going to increase or not. I
think we do.

UNIDENTIFIED MALE: Is that what\'s driving this though to biofuels?

DR. LAYTON: No, national security is driving it.

DR. DYKES: It\'s the cost.

MR. GRANT: It\'s the cost of energy is driving it.

DR. LAYTON: And \--

MR. GRANT: If we all switch to hybrid cars.

DR. DYKES: Yeah, increased demands, increasing costs, bringing things
into production that otherwise wouldn\'t come into production.

MR. DEMORGAN: Potentially decreasing supplies or less certain supply.

DR. DYKES: Yeah, yeah.

MR. DEMORGAN: So is there specific change then to that first part? Did
you want to make it clearer what\'s driving this?

UNIDENTIFIED MALE: I would say energy demands have increased the use of
crop-based, something like that.

MR. DEMORGAN: Have increased the use of crop-based \--

DR. DYKES: Alternative energy sources.

(Discussion off the record)

MR. DEMORGAN: So, we have energy demands have increased the use of
crop-based fuels.

UNIDENTIFIED MALE: I think you have to say government policy and energy.

MR. DEMORGAN: Okay.

UNIDENTIFIED MALE: You can\'t leave it out.

DR. VAN EENENNAAM: Then let\'s do it.

DR. CRAMER: Government policy in response to energy demands?

DR. LAYTON: No.

MR. DEMORGAN: Government policies.

DR. LAYTON: Because I worked in the 80\'s on biofuels and there is no
big \-- it wasn\'t cost, it was national \-- that\'s when it was
national security and we talked about it religiously. It was national
security.

MR. DEMORGAN: So, then if that\'s comfortable in terms of the \-- then
the second part, what Jerry was trying to get to, was genetically
engineered crops, either existing or to be created \-- I\'m not sure
that\'s the right terminology \--

MR. SLOCUM: New.

MR. DEMORGAN: \-- either existing or new.

DR. VAN EENENNAAM: So which current genetically engineered crops would
be used for biofuel?

MR. SLOCUM: Corn, soybeans.

DR. LAYTON: Canola.

MR. SLOCUM: They\'re not engineered to be used for fuel, just
engineered.

DR. VAN EENENNAAM: Because they\'ve got Roundup Ready^®^ doesn\'t mean
that they\'re readily available.

MR. SLOCUM: No, there are things out there that significantly change the
oil composition that make it, the starch composition that make it much
more adaptable for fuel uses.

DR. VAN EENENNAAM: Right, I understand that.

MR. SLOCUM: There\'s no demand for it.

DR. VAN EENENNAAM: But, I don\'t think that genetically engineered
current crops are being engineered for crop \-- for biofuel and so may
be developed for optimal or something. I mean, isn\'t that what you\'re
\-- isn\'t that the point we\'re trying to capture?

MR. SLOCUM: That\'s the real point.

DR. CRAMER: So that would go down in the text probably.

MR. DEMORGAN: But, Alison, you\'re suggesting genetically engineered may
be developed to provide or may be enhanced or/or developed to provide?

MR. SLOCUM: May be developed to be alternative sources of energy.

DR. VAN EENENNAAM: Yeah, there you go.

DR. DYKES: Developed to provide alternative sources.

MR. DEMORGAN: To provide.

DR. LAYTON: Okay. We can move on.

MR. DEMORGAN: Are you on in the below?

MR. GRANT: Yeah, I\'m below.

MR. DEMORGAN: So, that\'s the topic sentence statement. Good? Thanks.

DR. LAYTON: Remember substantive below because we really want to move
on. It\'s after 1:30.

MR. GRANT: It\'s substantive, at least to me it is, which is the
definition, I guess, right?

DR. LAYTON: Uh-hmm.

MR. GRANT: Second sentence says tools of biotechnology are being
employed to change oil or starch content. I mean, an additional concept
is the use of biotech to change cellulose content.

DR. LAYTON: Actually, by lignin content.

MR. GRANT: Well, cellulose for me, lignin for you?

DR. LAYTON: Lignin for me, cellulose for you.

MR. GRANT: It\'s cellulose is in raising corn but lignin in trees I
guess.

DR. LAYTON: It depends on what kind of fuel you want. If I\'m going to
burn it I want more. If I want alcohol \--

MR. GRANT: Okay. So, it\'s just not oil or starch, I guess. That\'s the
point.

DR. BUSS: It\'s alternatively if you said tools of biotechnology are
being employed to change composition for maximum energy production.

MR. GRANT: Then that would work. It seems to \--

MR. DEMORGAN: To change composition of. I think you said a couple of
more words.

DR. HERDT: Crops for commercial breeding.

DR. LAYTON: Maximum energy.

MR. DEMORGAN: Okay.

DR. LAYTON: Okay.

MR. DEMORGAN: Anything else on this, any other concepts? So, the
changes, that change and it\'s down there below that it\'s moved, that
language. Incorporate the suggested edit from Josephine earlier. Okay.
All right. Okay. Let\'s move on them to number 9. Carol?

MS. TUCKER FOREMAN: Let me just see what\'s still in there because I had
some \-- would you run it down just a little bit, Cynthia. Modern
applications are developed for bioenergy uses. This was suggested by
you, Josephine, but, I have a suggestion for the \-- it\'s disappearing
on me. Okay. I think that\'s absolutely the bottom line on this.

I thought it would be okay to say that important non-feed uses \-- there
is a reference to this increasing consumer acceptance \-- important
non-food uses of biotechnology products could be a direct consumer\'s
benefit that leads to greater public acceptance of the technology.

DR. SCHECHTMAN: Better than the other message.

MS. TUCKER FOREMAN: Since we want to \--

DR. LAYTON: Have you got that written down somewhere?

MS. TUCKER FOREMAN: Yeah. But, then I think \-- I don\'t think that
conflicts with what I think \-- the two go together. You want me to just
write it down and take it to Cynthia?

DR. LAYTON: Yeah.

MR. DEMORGAN: And is this to replace the last sentence?

MS. TUCKER FOREMAN: No. No. No.

DR. SCHECHTMAN: There\'s another sentence after this.

MR. DEMORGAN: I know, that\'s the last sentence.

DR. LAYTON: She just wants to make a change.

MS. TUCKER FOREMAN: I want to take out the \-- before it goes before
it\'s more novel applications are developed.

DR. SCHECHTMAN: Switch them around.

MS. TUCKER FOREMAN: Yeah, just switch those two around. I wrote it down,
Cynthia, and will bring it to you. Because I think the bottom line is
Josephine\'s point.

DR. JAFFE: So, Josephine\'s point will still be in or not in?

DR. LAYTON: It will still be in.

MS. TUCKER FOREMAN: Any time you\'re having non-food uses maintaining
the integrity of the food supply.

DR. SCHECHTMAN: But then that doesn\'t \-- alternatively it\'s not
necessary.

MS. TUCKER FOREMAN: I don\'t think \-- just getting this down and I\'ll
give it to you, Cynthia.

DR. LAYTON: Did she get it, Carol? You might want to look at my computer
and see.

MS. TUCKER FOREMAN: It has a phrase in there that I think is useful.
Would be a direct consumer benefit.

DR. JAFFE: Well, we\'re still keeping in ensuring the integrity of the
food supply?

MS. TUCKER FOREMAN: That\'s the last sentence. That\'s the \--

DR. JAFFE: Okay.

DR. DYKES: We\'ve given up on the integrity of the food supply, Greg.

MS. TUCKER FOREMAN: Consumer benefit and could lead to better public
acceptance of the technology.

MR. DEMORGAN: Okay. So, moving on to number 9 then. It is important to
anticipate the impacts of the new generation of technologies such as
RNAi gene silencing technology that would be available in the next ten
years on our regulatory policy and on testing. So, we had Greg had a
comment and that was it. Greg?

DR. JAFFE: My comment was that the topic sentence seemed to talk about
three things but the text only seemed to deal with one of those things
so, I mean, the text is on regulatory issues whereas this topic talks
about agriculture, very broad, testing very broad, so, my proposed
change would be to say it is important to anticipate how a new
generation of biotechnologies that are not transgenic such as RNAi gene
silencing technology will be addressed by the regulatory system period.

MR. DEMORGAN: So, how a new generation of \--

DR. JAFFE: Biotechnologies. They way we define biotechnology is very
broad and technology is like too broad.

DR. SCHECHTMAN: And are modern.

DR. LAYTON: They\'re not genetically engineered.

DR. JAFFE: No, they can\'t be modern. You can\'t use the word modern.
Just think what the future will be, super modern or something.

MR. DEMORGAN: Genetically engineered.

DR. JAFFE: That are not transgenic. I said genetically engineered.

DR. LAYTON: That are not \-- I think transgenic looks better though.

DR. JAFFE: That are not transgenic such as RNAi gene silencing
technology.

DR. LAYTON: Silencing.

DR. JAFFE: Silencing. Will be addressed by the regulatory system. Just a
proposal.

MR. DEMORGAN: Okay. So, reactions, comments? I didn\'t see the order.
Carol?

DR. CRAMER: We have to be careful because RNAi as utilized in plants
currently may be introduced through a transgenic step and you have \--
so part of the issue here is that you\'re truly merging concepts of what
is a transgene, whether if I have all pieces that emerge from tomato and
I put them back in tomato and there\'s nothing else and what I\'m doing
is shutting off so that there\'s no new product made, is this
transgenic?

So, there are issues here of how you test that and you can\'t just say
non-transgenic because, in fact, one, the most common currently of
introducing an RNAi strategy in plants is to utilize a DNA, an
integrated DNA intermediate.

MR. DEMORGAN: So, in terms of that would you just remove the example?

DR. CRAMER: Well, I think \-- I mean, what you want to do is actually
\-- I think what you might want to do is to say that are not transgenic.
We need to say it\'s a new generation. We could say in some cases are
not transgenic.

DR. LAYTON: Or that may not be transgenic.

DR. CRAMER: Yeah.

DR. LAYTON: Actually that may not be transgenic.

DR. CRAMER: Yeah.

MR. DEMORGAN: You keep the example?

DR. CRAMER: I think so because I think that\'s what you want to do is
highlight this is one of the things that\'s fundamentally new.

DR. SCHECHTMAN: Well, is it that may not be transgenic but that may not
mean through transgenic organisms?

DR. CRAMER: But, again, I think that\'s a matter of new definition that
needs to be addressed.

MR. DEMORGAN: All right. Let\'s take the other work in this. Josephine,
Alison, and Michael.

DR. HUNT: It\'s essentially the same comment. If it can\'t be transgenic
I think we\'ve already answered that and discussed it. I\'m okay with
that.

MR. DEMORGAN: Okay. Alison?

DR. VAN EENENNAAM: I guess I\'m not sure how you would make RNAi without
using both. We\'ve made transgenic and genetic. We\'ve engineered the
same thing which I don\'t know that they are. But, in our context of our
definition of transgenic which is genetically engineered \--

DR. CRAMER: You could use viral-vectored, a transient viral-vectored
system to pull it in and to trigger a non-integrative mechanism to do
it. There are several appropriate things that one could do.

MR. SLOCUM: That doesn\'t sound very healthy.

DR. CRAMER: I mean, so there\'s a number of strategies.

MR. DEMORGAN: And so between \-- I mean, the folks who understand that
\-- Alison, given what Carol just said, are you comfortable with that
language at present? So, hearing nothing I\'m going to presume that
Alison, at least, is okay so at least for the time being I\'m going to
go to Michael and then Bob.

DR. DYKES: I just wanted to comment. It is for this reason. Since we
also have products on the market that aren\'t necessarily transgenic
that I put the placeholder earlier on the definition.

MR. DEMORGAN: Okay. Bob?

DR. HERDT: Yeah. I think that we should strike in the next ten years on
agriculture and regulatory policy needs around testing. Because I think
it really is, how are these new things going to be addressed by the
regulatory system? That\'s where you have a problem.

MR. DEMORGAN: Okay. Duane?

MR. GRANT: I mean, it appears to me it\'s not just going to be the
regulatory system, but, also the marketing system, the market
environment response to these which will be triggered in part by the
regulatory system\'s response, but, the market doesn\'t always interpret
it the same as the regulatory system does.

DR. LAYTON: I wouldn\'t put a market environment. I\'d just say and the
market.

MR. GRANT: Right.

DR. HERDT: I think that the market is going to do what it\'s going to do
and I don\'t think anticipating or not anticipating it has any \-- we
don\'t advise USDA to try to anticipate that. I really don\'t. I mean,
it\'s going to happen.

MR. DEMORGAN: Duane, are you okay not including that for the time being?

MR. GRANT: I frankly don\'t know. I mean, I don\'t know how \--

MR. DEMORGAN: Do you want to put a concept in a paragraph?

MR. GRANT: I\'ll tell you, after the market reacts, I guess, if the
market reacts negatively I\'m going to be really unhappy.

DR. SCHECHTMAN: Can I ask one question? Has this been addressed by
talking about how it being important how it\'s going to be addressed by
the U.S. and foreign regulatory systems?

MR. GRANT: It\'s not just no, it\'s not just foreign, it\'s also the
domestic system.

MR. DEMORGAN: Bob?

DR. HERDT: Suppose you anticipate the market reaction is going to be
negative, you\'re going to prevent it by regulation?

MR. SLOCUM: Well, they don\'t develop it.

MR. GRANT: To a certain degree \--

DR. HERDT: Scientists may develop it. Scientists are the guys developing
\--

MR. SLOCUM: We need money, remember? They don\'t get any money unless
they can sell it.

MR. DEMORGAN: So, the question here is for Duane, at least Bob, and I\'m
not hearing anybody else speaking up on this. Bob\'s suggesting not
including it. So, I suggest you just put it as a concept and maybe work
into the text. Carol\'s got a comment on it?

DR. LAYTON: No, she was just asking him.

DR. CRAMER: I\'m about to be jumped on seriously. What about the \-- I
mean, I think one of the things we can ask is, for some of these that
are not transgenic, will they be regulated under the current system or
should they be? I mean, it\'s actually a question of a whether these
things. As it stands now some of these things may be outside and it\'s
essentially no different than mutagenesis except it\'s a bit more
precise.

And, so, one could throw out the concept of, you know, as new things
emerge, will these fall under the current regulatory system?

DR. LAYTON: Well, I think that\'s what you said.

MR. SLOCUM: I think will they be addressed by the regulatory system. I
think that\'s \--

DR. LAYTON: That\'s it.

MR. SLOCUM: \-- the issue.

MR. GRANT: I would be all right with that being the issue as long as the
market is addressed in the discussion below. I can \-- I agree, concur
that as long as the regulatory system in terms of blind eye as they have
the mutagenesis so far then the market will probably also ignore them.

DR. LAYTON: But, we\'ve been doing mutagenesis for years.

MR. GRANT: Yeah, I know, and we can have a discussion about that.

DR. LAYTON: I understand that, but, we\'ve been doing it for a long time
in a unregulated environment.

MS. TUCKER FOREMAN: But, then the Food Channel did a program on it and
that was the end of it.

MR. DEMORGAN: Okay. So, we need to move on so the question really is,
you know, Duane seems to be, at least, able to live with the concept for
now and there will be an opportunity \-- Daryl\'s got \--

DR. BUSS: Well, I guess I\'m hearing two different questions and so the
question I was raising, what I was hearing last, would suggest rewording
that to say it is important to consider whether a new generation of
biotechnologies will be transgenic, will be addressed, or should be
addressed. That\'s a very different statement than anticipating how they
will be addressed.

DR. JAFFE: I had put down how they should be addressed. They may be
addressed by non-regulation. I don\'t think that\'s \-- that suggests
\-- I mean, FDA would say they regulate \-- they have a voluntary basis.
They regulate \-- they show all the food as safe. They would say they
regulate mutagenesis crops as much as they regulate any other kind of
crops. They make sure that they\'re safe. They would say they\'re under
their purview. They say it\'s a regulated product. They just don\'t have
any affirmative pre-market approvals or anything of them, but, they
would be considered a regulated product.

DR. LAYTON: If somebody got sick they\'d be \--

DR. JAFFE: That\'s right. That\'s right. They don\'t have high promise
(sic).

MR. DEMORGAN: So, Greg, are you suggesting keep it how \--

DR. JAFFE: That\'s right.

MR. DEMORGAN: \-- well?

MS. TUCKER FOREMAN: How and whether? Whether and how?

DR. DYKES: I\'d rather just say how because I\'m where Greg is. If they
decide not to then that\'s how.

MR. DEMORGAN: Are you all right with that, Daryl, given the response?

DR. BUSS: Yes.

MR. DEMORGAN: Okay. And is it, will, how will be addressed? Okay. So,
Greg, Carol, more comments?

DR. JAFFE: I have comments on the text.

MR. DEMORGAN: So we\'re done with the topic sentence statement. Okay.
So, concepts, additional concepts to include in the text itself.
Questions about it?

DR. JAFFE: This one in particular, I think, you need to be very careful
about the language for what are biotech and transgenic and things like
that because under current, the first sentence, fits under current
government biotechnology-related regulatory definitions. You can\'t use
biotechnology there. You got to use transgenic or something.

But, more particular, my difficulty is, I think, from this redrafting
that you all have to be careful what words are used there. The last
sentence, there are a couple of comments. Again, here, these
technologies like transgene technologies will influence the overall
worldwide debate on agricultural biotechnology products. I don\'t think
there\'s an overall debate on agricultural biotechnology products.
There\'s a debate on genetic engineering.

I think biotechnology is a broad word you\'re using so then by saying
like transgene ones it doesn\'t make any sense to me anymore because
you\'re sort of saying non-transgene products will affect transgene \--
the transgene debate. That doesn\'t make any sense to me. So, I don\'t
know what \-- I understand the point somebody was trying to make there
which is new biotechnologies may affect how we perceive genetic
engineering.

But, we have to be real careful about the language here.

MR. DEMORGAN: So, Greg, your edit to that sentence is instead of use
technologies like transgene technologies is to say?

DR. JAFFE: It\'s sort of weird because of our definitions here. This
becomes very \--

MR. DEMORGAN: Right, and you\'ve already said that it needs to be
addressed and, so, you\'re not suggesting then, you\'re offering
comments which is probably sufficient for now and the re-drafters will
address it.

DR. LAYTON: This new generation of biotechnologies is what we called it
in the sentence above.

DR. JAFFE: Okay. Unlike. Okay. Might influence the overall debate on
genetically engineered \--

DR. SCHECHTMAN: On genetic engineering.

DR. JAFFE: Right.

DR. LAYTON: Okay.

MR. DEMORGAN: Can you just read that back?

DR. LAYTON: I just took the words we had from before. New generation of
biotechnologies. So, this new generation of biotechnologies, and then I
have, may influence the overall worldwide debate on genetic engineering
\-- genetically engineered products \-- I\'m sorry. On genetic
engineering. It was genetic engineering. And it will be important for
the government to be ready to articulate policies regarding this new
generation of technology. These new technologies or something like that.
DR. JAFFE: I would delete that second half of the sentence and replace
it with the government will need to specify how the regulatory system
will ensure the safety of those organisms. The idea being ready to
articulate policies.

DR. LAYTON: Okay. Say that again, Greg. The government \--

DR. JAFFE: The government will need to specify how the regulatory system
will ensure the safety of those organisms. And that may doing something
or not doing something.

DR. LAYTON: The reg system will ensure the safety \--

MR. DEMORGAN: Of those organisms.

DR. LAYTON: \-- of the resulting organisms.

MR. DEMORGAN: Okay. Other comments on this language, the description?

DR. SCHECHTMAN: Just one observation which is this is another
recommendation.

MR. DEMORGAN: Unless.

DR. LAYTON: Unless I rework it.

MR. DEMORGAN: Right, exactly.

DR. LAYTON: Even so, great idea on that sentence, Greg.

MR. DEMORGAN: Michael?

DR. DYKES: This is we\'re talking about the organism and, again, I think
it comes back to open it up to our thoughts when we come back to the
definitions thing in future meetings, but, I don\'t think this is just
limited to the organisms. We\'re talking about the organism and its
products.

DR. LAYTON: Organism and its products.

DR. DYKES: Yeah, that\'s why I think for the sake of the previous papers
and this one we\'ve talked about the products of modern biotechnology,
not to re-plow that ground, but, I mean, you get into distinguishing
between organism and products you get quite tied up here.

DR. LAYTON: Okay. We\'ll work on it.

MR. DEMORGAN: Okay.

DR. LAYTON: Greg, do you still have a comment?

DR. JAFFE: No, I\'m sorry.

MR. DEMORGAN: Okay. Anything else on number 9? All right. We are done
with the new topics of discussion. They are no longer new. They are now
current. So, the next document we need to pull out is the thickest one
you probably have and this is the following: a brief description of
topics discussed. Does anybody not have that in front of them? The page
numbers, it\'s 35 pages long.

DR. SCHECHTMAN: There\'s a paragraph in italics.

MR. DEMORGAN: Right. Does anybody not have the document in front of
them? Okay. So, as they\'re just pulling this up just in case we need to
pull the documents over the text, the first issue, number 10, we just
kind of kept going with the numbers, I guess as I understand it, this
was one of the ones to park. Okay. Any questions about that?

DR. DYKES: Why are we parking it?

MR. DEMORGAN: This is the one that goes to \-- it\'s one referring to
T&L report.

DR. DYKES: All right.

MR. DEMORGAN: Okay. It doesn\'t mean it\'s being removed, just parked
for the time being. Okay. All right. So, then let\'s move to number 11
on page 2. The co-existence of different agricultural products and
production methods intended to meet different market specifications has
become more complex with the emergence of biotechnology derived crops.

Alison, Daryl, and Randy, and Greg, and Mardi all commented.

DR. SCHECHTMAN: Were any of those comments on the topic sentence?

MR. DEMORGAN: So, and, again, these are older topics. You\'ve had some
discussion at the very least about these so hopefully the topic sentence
is going to be closer than some of those newer ones throughout as we go
through this. So, we should rip through these.

MS. TUCKER FOREMAN: Oh, yeah.

MR. DEMORGAN: Come on, Carol, the antithesis here, right. Okay.

MS. TUCKER FOREMAN: I could take out a few words.

DR. LAYTON: That\'s what I\'ve got.

MR. DEMORGAN: Okay. So, any comments on that topic, minor edits which
can be dealt with? Okay. Then what about the text, the issue, does it
represent the \-- does it accurately inform the reader about the topic
statement?

MS. TUCKER FOREMAN: No, this really is one where we sat with everybody
on a phone call about a year ago and, I thought, rewrote this one to
everybody\'s satisfaction.

DR. SCHECHTMAN: Okay. Except that it was way long.

MS. TUCKER FOREMAN: That\'s true.

DR. SCHECHTMAN: Yes.

DR. VAN EENENNAAM: The last sentence.

DR. HERDT: Several people suggesting removing the last sentence.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: I would suggest that rather than \-- you know \--
this is one that we may still not be in agreement on it, but, where we
had some agreement and the length is the only problem I would suggest
that we try to deal with that, you know, between staff and a work group
and not spend a lot of time trying to edit it down right now.

DR. LAYTON: Okay. Thank you.

MR. DEMORGAN: Okay.

DR. LAYTON: Michael has a comment.

DR. SCHECHTMAN: Yeah, I mean, rather than working very hard on trying to
go back, certainly the attempt was made in this was to capture the
important points and keep things within roughly the same length. I mean,
if we don\'t talk about this from the standpoint of, you know, detailed
words, but whether the concept, whether the relative concepts have been
put in here, you know, it will go back to a group that will look at it
again.

MS. TUCKER FOREMAN: Yeah, that\'s what I\'m suggesting.

DR. SCHECHTMAN: Yeah, yeah, but, I just wanted to get \-- make sure we
have a rough check on it.

MS. TUCKER FOREMAN: I think Greg actually might have had a substantive
issue with it.

DR. JAFFE: Right, the last sentence.

MS. TUCKER FOREMAN: Right.

DR. LAYTON: That we\'re taking out.

DR. SCHECHTMAN: Everyone said take it out.

DR. LAYTON: Okay.

MR. DEMORGAN: So, we\'ve run into a little logistical challenge in terms
of the document so that\'s why.

DR. LAYTON: Now, this twelfth one is \--

MR. DEMORGAN: It\'s red lined. Strike out the last sentence.

DR. LAYTON: And the twelfth one is parked.

MR. DEMORGAN: Okay. So, number 12 is another of the T&L\'s so I need any
comments before. Is that understandable to everyone why that\'s parked?
Okay.

Number 13 is the same thing, also a T&L. Any comments? All right. Then
number 14. The regulatory system for plant-derived products not intended
for food or feed use must be assured appropriate containment. Address
all relative safety considerations and ensure the integrity of the feed
and food system. But, some are not satisfied that the current approach
adequately meets these requirements and prevent contamination in the
system.

Okay. Okay. So, let\'s see. Alison.

DR. LAYTON: Keep going.

MR. DEMORGAN: So, Alison, Daryl, Bob, Josephine, Greg, Mardi. So a lot
of comments on this one. I guess the first question is folks on the
topic sentence itself. Comments that have been made related to edits to
that and/or the substantive changes. Yes?

DR. HUNT: I have a couple, yeah, that relate to the heading and that was
actually, move all relevant that address safety considerations. And also
I have another suggestion to delete the last bit, and will prevent
unintended contamination in the system.

MR. DEMORGAN: And strike that last part?

DR. VAN EENENNAAM: I\'ve got \-- I changed that to and are concerned
about rather than \--

MS. TUCKER FOREMAN: The concern, as I understand it, as filed by the
Food Processors Association in the comments to USDA, is that they don\'t
think there is a regulatory system that will prevent that contamination.

DR. VAN EENENNAAM: Are there words different to that? Because they\'re
concerned about unintended contaminations in the system.

DR. JAFFE: I mean, I think it\'s preventing \-- the system isn\'t going
to work.

DR. HUNT: I guess I had moved it because I thought earlier on in that
sentence we addressed that when we say assure appropriate containment
and then we talk about meet these requirements. So, to me, we had
addressed in the last sentence, the last few words, earlier on.

MR. DEMORGAN: So, the proposal is strike it. Alison, you had suggested
that you accept Josephine\'s rationale. Greg, is it with respect to that
specific strike?

DR. JAFFE: Yeah. I mean, I prefer that it still remain in.

MR. DEMORGAN: Put brackets around it, please. Okay. So, Greg, why do you
want to \-- given what Josephine just said about ensure appropriate
containment and meet these requirements, that rationale, why is that
necessary in your mind?

DR. JAFFE: Well, there is a difference between appropriate containment
and preventing unintended contamination in the system. I think those are
different and I\'m sending an overall view if we\'re going to go the \--
if we\'re going to go the route of some people say this and some people
say that then the people who say certain things should be allowed to say
it however they want to say it.

If we\'re not going to go that route and we all try to come to consensus
then it\'s fine, but, when we start getting into some of these some say
this and, although you\'re trying to describe it, what those people are
saying.

MR. DEMORGAN: So you\'re saying that this rises to that level?

DR. JAFFE: Yes.

MR. DEMORGAN: This is the first time we\'ve gotten there, so, that\'s
fine. I was just asking kind of from a \--

DR. JAFFE: Yeah.

MR. DEMORGAN: So the reason some people in their mind want to strike
this is because?

DR. JAFFE: I don\'t know why they want to strike it. I\'m just saying
that for those of us who do think that that\'s a good description of
what the problem might be.

MR. DEMORGAN: Okay. Michael?

DR. DYKES: I was just going to say I agree with Josephine as far as
anything after requirements. I think it\'s, as she stated, I think
what\'s stated covers that.

MR. DEMORGAN: Others want to weigh in on it? Lisa?

MS. ZANNONI: Yeah. It\'s when you get to your concern, Greg, at the
bottom, if you just put what Josephine said, must ensure appropriate
containment to ensure the integrity of the food and feed system period.
The integrity of the food and feed system \--

DR. JAFFE: Well, I hold the comment on the language including integrity
of the food system I don\'t.

MR. DEMORGAN: Okay. So, it\'s bracketed for the time being. Greg, you
have some other comments and then we\'ll have to cycle back to look at
this.

DR. JAFFE: Yeah, I have some other comments. First, at the beginning of
it, the regulatory system for plant-derived products, I mean, I think
they used to say \-- oh, how do I have it here \-- genetic engineered
plants that produce a non-food product because there are a lot of
plant-derived products out there that are not genetically engineered.

MR. DEMORGAN: Genetically engineered plants.

DR. JAFFE: That produce a non-food product.

DR. LAYTON: What about animals?

DR. JAFFE: That\'s fine, plants and animals, but, I don\'t have a
problem with that, or, genetically engineered organisms that produce a
non-food product. But, to me, plant-derived products are much broader
than \--

MR. DEMORGAN: I mean, the way this was written previously was it was all
about plants.

DR. LAYTON: It is and it could be. I just had a question.

MR. DEMORGAN: Okay.

DR. LAYTON: So, it\'s regulatory system for genetically engineered?

DR. JAFFE: Organisms that product a non-food product.

MR. DEMORGAN: Must ensure? Is that where you\'re going so it replaces
all that language?

DR. JAFFE: No, that was before must ensure. It says \-- you know \--

DR. LAYTON: Right. To pick back up at must ensure.

DR. JAFFE: It\'s not replacing must ensure. It\'s just \--

DR. LAYTON: I know. We start back in the text again.

DR. JAFFE: Yes. Yes.

DR. LAYTON: So I\'m starting at plant-derived and going striking through
use.

MS. TUCKER FOREMAN: Regulatory system for GE organisms that produce
non-food products.

DR. LAYTON: Must ensure the appropriate containment addressing safety
considerations.

DR. JAFFE: And I would say and ensure the safety of the food supply. I
don\'t know what it means, the integrity of the food feed system. Maybe
that\'s a term of art that others in the food-feed system use, but, \--

DR. LAYTON: Okay. Are you comfortable if we still say food-feed system?
Safety of the food-feed system.

DR. JAFFE: I think consumers are concerned about the food supply. I
don\'t think they\'re concerned about the food-feed system. I think
they\'re concerned about the food supply.

DR. LAYTON: Yeah, but, \--

DR. JAFFE: The safety of it.

DR. LAYTON: \-- Joe cattle rancher is.

DR. SLUTSKY: If I could, I mean, I think the integrity of the food-feed
system is larger than what you are saying. There are other components to
it so you have safety concern and then you have the, you know, the buyer
and seller component to it, and the buyer, you know, wants to buy
something and the seller needs to be able to sell what the buyer wants
and that goes to the larger integrity.

DR. JAFFE: And I\'m sure the regulatory system\'s role is \-- I\'m not
sure what the regulatory system\'s role is in that.

DR. SLUTSKY: Well, that could be too.

DR. JAFFE: And this is saying the regulatory system must ensure.

DR. DYKES: Safety of the food-feed supply.

DR. SLUTSKY: It depends upon what you\'re trying to get at.

MR. DEMORGAN: I think your point is a good one but he\'s going off on
what this currently says. Carol, you wanted to get in on this?

MS. TUCKER FOREMAN: Yeah. I have \-- I think the feed supply is less
important than the safety of the food supply and we\'re talking about
this kind of issue you either have to use the food supply or
differentiate. If it means the issue of the safety of the food supply to
talk about the food supply.

DR. LAYTON: Do you think that Russell would not be as concerned about
the feed supply system for his hogs?

MS. TUCKER FOREMAN: I think Russell\'s more concerned about the safety
of the health of the people who eat his product.

MR. DEMORGAN: So, Carol, did I hear you say you could split it?

DR. LAYTON: I\'m just using you since you\'re a pig farmer.

MS. TUCKER FOREMAN: This is a general issue. This keeps popping up all
the way through and, you know, in my view, concerns about the safety of
the food feed system misplace the emphasis here which I think should be
on the safety of the food supply.

MR. DEMORGAN: When somebody\'s talking I\'ve got to stay with them. I
can\'t interrupt them and go straight to you, but, I understand, if
you\'re waving you\'ll go in front of Russell, honestly, unless he
waves.

What I\'m trying to understand, Carol, is you\'re raising up a more
global point and it\'s \--

MS. TUCKER FOREMAN: Yes.

MR. DEMORGAN: That\'s helpful for people to understand. The question
that I have, at least the way we\'re proceeding right now is, so are you
proposing that it just say of the food supply and we strike through feed
system or of the food supply and the feed system?

MS. TUCKER FOREMAN: You could say ensure the integrity \-- ensure the
safety of the food supply and the integrity of the feed system.

MR. DEMORGAN: Okay. So, that\'s an alternative. So, Carol\'s waving and
then we\'ll go to Russell to speak for himself.

DR. CRAMER: Two points I\'d like to make. One is that I think the safety
of the feed system is actually one of the areas for which there\'s a
really big focus and there\'s issues that will emerge in the next couple
of years that are going to be animal vaccines for pigs, for example, and
there the real issue to make sure that they don\'t move into the regular
food supply.

I also would say that you need to remember who the audience is, which is
the Secretary of Agriculture for which food and feed supply is, I mean,
I would say from that point of view the food supply is a significant
player here and is important.

MR. DEMORGAN: Okay. Russell?

MR. KREMER: I don\'t think you can lump it together, food and feed, and
I kind of tend to agree with Carol\'s approach. I don\'t know, maybe it
can be more clearly defined. I think we\'ve already set a precedent that
was deemed satisfactory to animals, not necessarily deemed satisfactory
to humans in the case of StarLink^®^.

I think that this whole thing about integrity, I like that word be on
the feed side of it because, you know, when I\'m looking at a product
it\'s not just safety for my animal, it\'s also, you know, is it, you
know, the stuff that\'s made, intended for industrial uses isn\'t
necessarily good for my animal.

For instance, there\'s some, as an example, that corn stalks in the
field from BT corn, my cows won\'t eat it, so, I mean, integrity is a
good word to use on the feed side and safety on the food side.

MR. DEMORGAN: Okay. So, we\'ve got three cards up and then we\'ll figure
out where to go. Lisa, and Carol, and Michael.

MS. ZANNONI: Since she\'s talking about the regulatory system in the
U.S., the regulatory system, food-feed is together in an approval so
you\'ve written separate that in the U.S., and then you also talk about
containment and in the U.S. the regulatory system shouldn\'t distinguish
containment between food and feed. So, I think if you\'re only talking
about safety so I think since we\'re talking about a system that keeps
food-feed together then we should put them together.

MR. DEMORGAN: Okay. So, the safety is an okay word from your perspective
of the food-feed system and you were given the rationale for it.

Carol?

MS. TUCKER FOREMAN: I still would prefer \-- well, they\'re regulated
within different areas of FDA. The FDA clearly invests far fewer
resources in assuring the safety and integrity of the feed supply than
they do food. And it\'s \-- you know \-- it\'s more than message than
anything else. As Paul pointed out, I\'m making more \-- trying to make
a more global point than this one specific one. And I\'m not sure why
saying the integrity of the safety of the food supply and integrity of
the food system hasn\'t satisfied that.

MR. DEMORGAN: Okay. So, Michael and then Michael and then we forgot \--
I mean, we want to keep moving. We may not resolve every single \-- I
mean, if we just stop here and dig in on this and get it to it by 3:15
that\'s when we\'re done, right, so, we may have to agree to disagree
for the time being and make sure we understand how we flag it and figure
out what the next steps are.

Michael?

DR. DYKES: I just want to say that I think we\'ve got to be concerned.
Most of the products are out there for feed consumption today. And also
it\'s the feed safety because we\'re going to, in turn, eat the meat,
eat the animals that have been eating the feed. So, I think that
ultimately it\'s all going to come back to food.

So, that\'s why I think they should be together. I think also from the
product standpoint it\'s important to know that they\'re both safe from
the food and a feed perspective just as Russell\'s comments about BT
cornstarch. I mean, I think part of the thing is, is it safe for cows to
eat. Whether they eat them or not is a different issue, but, the fact
that they are safe to be eaten for animal feed is an important
consideration. Or, otherwise, that\'s exactly what you have out there,
it\'s okay for humans but not okay for cows to eat. You know, that\'s
just not what the system is.

MR. DEMORGAN: Okay. Michael Schechtman knew the answer.

DR. SCHECHTMAN: No, actually it\'s just with a little bit of good memory
from the last meeting. There was a question about safety versus
integrity and I recall the comment that Carol had made at the previous
meeting about the fact that the regulatory system for these PMP\'s
can\'t be depended upon the ensure the safety of the food supply.

You know, that was why the word integrity was there, I think because it
can deal with one component of that which is to say the lull of these
organisms in the food supply \--

MS. TUCKER FOREMAN: You\'re right and I remember it now that you raise
it because I go back to the issue that one of Ron\'s colleagues raised
which was he doesn\'t care if it\'s safe. His customers don\'t want it
in the corn flakes. That\'s the integrity part of it. I still have a
problem with lumping food and feed together. You know, I don\'t want to
hold this up about it at this point.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: Greg, are you going to address the more general
point here of who gets to kind of state what the position is because
there are issues down in the third paragraph that I don\'t think address
\-- I think they\'re referring to concerns that I had but don\'t address
them in a way that\'s \--

DR. LAYTON: Could you send me how you want them addressed?

MR. DEMORGAN: Can we just real quick before we \--

DR. JAFFE: Putting back integrity aside, I think.

MR. DEMORGAN: So, integrity of whatever, we\'re not there yet. I think I
heard \--

MS. TUCKER FOREMAN: Leave that food-feed system. If we have time we can
come back.

MR. DEMORGAN: Greg, are you okay with that?

DR. JAFFE: For now.

MR. DEMORGAN: Okay. So, it\'s of the food-feed system. Okay.

MS. TUCKER FOREMAN: And its safety and integrity.

MR. DEMORGAN: So, that\'s not what I heard you say, Carol. I heard you
say you could live with integrity given the way that Michael revised or
reminded you of your prior conversation and I heard Greg saying he\'s
okay with just integrity.

MS. TUCKER FOREMAN: Okay.

MR. DEMORGAN: Okay. So, okay. So, now, I guess Ron and Duane have more
comments on this. Note that we do have agreement here on this right now
for the time being.

MR. OLSON: I was just going to add, the practicality is when a processor
buys corn he doesn\'t know if it\'s gone to food or feed. And some parts
of it go for food and some parts of it go for feed. From a practical
standpoint, it\'s the same grain going into the thing so you got to
regulate it the same. You can\'t separate it.

MR. DEMORGAN: So your comments are on the integrity of the food
feed-system.

MS. TUCKER FOREMAN: I\'m not going to quarrel with that, but, I do want
to point out that this is a little different than our original one
because we\'re now talking about a regulatory system for GE organisms
that produce non-feed products and we\'re assuming that it might mean
animals as well as plants. And that \--

DR. LAYTON: If you want it to be plant I\'m comfortable saying
genetically engineered plants. I just suggest \--

MS. TUCKER FOREMAN: I think the way that you restated it is more
appropriate.

DR. JAFFE: Organisms. I thought we just put organisms.

DR. LAYTON: It was plant-derived products so what I said was organisms.

MS. TUCKER FOREMAN: Yeah, genetically engineered organisms.

DR. LAYTON: That\'s what I had put.

MR. DEMORGAN: Okay. So, we still have this issue. It\'s bracketed at the
bottom. Duane, is yours about the topic or the substance?

MR. GRANT: The paragraph below it.

MR. DEMORGAN: Okay. So hold just one second if you don\'t mind.

MR. GRANT: Sure.

MR. DEMORGAN: There\'s still this issue that Greg has raised and others
have suggested that it be stricken and Greg suggested that it not, so,
he\'s indicated that appropriate containment is not the same as the
concern about unintended contamination. Is it okay to leave it for the
time being? Can people live with that? So, and/or concerned about
unintended contamination \--

DR. JAFFE: I had and/or prevent. That was what the original language
was.

MR. DEMORGAN: Right, it\'s been changed. So, you\'re not comfortable
with it, saying that, are concerned about? Right? You want it back is
what you\'re saying?

DR. JAFFE: Because the system is not concerned about.

MR. DEMORGAN: This is about the some. I\'m not sure some. It\'s the some
that are concerned.

DR. JAFFE: Some are not satisfied that the current system adequately
meets these requirements and will prevent and the way I read the
sentence is \--

MR. DEMORGAN: Grammatically, there\'s a little challenge there.

DR. JAFFE: \-- some people.

(Discussion off the record)

MR. DEMORGAN: Some stakeholders are not satisfied that the current
approach (1) adequately meets these requirements and (2) \-- I mean, I
don\'t think we need that.

DR. JAFFE: And that\'s why I said I think grammatically our concern
there is not \-- it\'s not modifying that. I\'m not articulating this
well.

DR. HERDT: A concern that it will not prevent \--

DR. JAFFE: The current approach (1) adequately meets these requirements
and (2) will prevent \-- and are concerned. That\'s why.

DR. VAN EENENNAAM: Well, to me, you can also read that as some
stakeholders will prevent \--

MR. DEMORGAN: Right, that\'s why I\'m saying, grammatically it doesn\'t
quite work, but, let\'s \--

DR. JAFFE: We can work on it.

MR. DEMORGAN: \-- leave it. It\'s going to be subject to a grammatical
edit on the sentence. Okay. We\'re done with that topic statement, okay.
Duane and I think Carol and Greg have also been alluding back and forth
to some bigger issues here, so, Duane first.

MR. GRANT: I\'m going to use my card for two things and, first of all,
just bracket the word prevents and then we can have a long debate about
whether \-- what was meant by the word prevent. Is that zero? What is
acceptable, zero? So, I just need to bracket that and understand the
context of the word doesn\'t work.

And, another one my card was up for was, there\'s a concept, as
contained in the paragraph below, that talks about two-thirds of the way
down the sentence on the left starts, especially because for some of the
potential industrial-producing plants. The incentive for producers to
stringently control their use may be less than for those for medical
uses due to lower profit margins and acreages.

I\'d like to strike that whole concept thing, all of those words.

MR. DEMORGAN: So, the whole sentence?

MR. GRANT: Everything I read.

DR. LAYTON: No, just especially. It\'s a comma. It ended above with the
word products is what he\'s done.

MR. GRANT: Clear to the period.

DR. LAYTON: So the remaining sentence would be some of these concerns
including heightened public emotions as well as perceived
liabilities/commercialism in the food industry for both types of
products.

MR. GRANT: Yes.

DR. LAYTON: The next sentence then reads, the federal government\'s
ability to successfully address the issues of containment and public
confidence, blah, blah, blah.

MR. DEMORGAN: So, comments about that edit specifically is, Michael,
yours to that specifically?

DR. DYKES: No.

MR. DEMORGAN: Get back to yours. So, any concerns about that edit? Okay.
That it, Duane?

MR. GRANT: Yes.

MR. DEMORGAN: Greg?

DR. JAFFE: I had a question about the first sentence. And it really gets
to an issue that I\'ve been talking about for the past four days. What
do we mean by products? I read the first sentence as new specialty
products from plants for medical-industrial markets. That, to me, is not
the crop itself, but, is the thing produced by the crop because it says
new specialty crops, pharm plants.

DR. LAYTON: New specialty crops from genetically engineered plants.

DR. JAFFE: New specialty products.

DR. LAYTON: From genetically engineered plants.

DR. JAFFE: Right. For medical-industrial markets.

DR. LAYTON: Organism.

DR. JAFFE: Right, whatever. So, are there systems currently for specific
regulatory oversight of these products by USDA? And I\'m not sure what
the regulatory \-- first, I\'m not sure what the regulatory oversights
for the products of the plants at USDA to me is more EPA and FDA and so
my question \-- and then the next sentence doesn\'t seem to talk about
the \-- we\'re talking about contamination here. Are we talking about
containment?

Those are because USDA was regulating the crops but they\'re not
regulating the products of the crops and I think we either need to \--

DR. SCHECHTMAN: Clarify it.

DR. JAFFE: \-- separate out this issue only to beyond \-- it\'s my
preference to only have this discussion about the crop, not have a
discussion here about the regulation of crops, but, from the crop.

But, if we\'re going to go there I think you need the EPA and a whole
bunch of other regulatory agencies and I don\'t think USDA is actually
the one regulating most of the products. They may if it\'s an animal
drug or animal vaccine.

There are certain kinds of animals which they do regulate. I think it\'s
too complicated. And I think all these sentences need to be rewritten
with that in mind. I\'d feel more comfortable with that.

DR. DYKES: I\'d agree with Greg\'s concept of the first, limit it to the
crops and not get into all the products.

DR. LAYTON: Can I end that first sentence at the end of benefits and
then start the next sentence with systems and then I can differentiate
in there the fact that the systems at USDA for the organisms? Systems
currently exist for specific regulatory oversight of these organisms by
USDA.

DR. JAFFE: I\'m not sure that FDA regulates per se the organisms. They
may have some \-- I would eliminate the FDA reference and say we\'re
just talking about the USDA.

DR. SCHECHTMAN: This is organisms in addition to plants.

DR. JAFFE: All right. Then it would be \-- it\'s for the animals, not
the pharmaceutical. That\'s right.

MR. DEMORGAN: So, just to track it up there. After, you know, you say
health and economic benefits, it\'s period, right, is that what you\'re
proposing?

DR. LAYTON: Right.

MR. DEMORGAN: Pat?

DR. LAYTON: Yeah.

MR. DEMORGAN: And then strike \--

DR. LAYTON: Then I would start that next, systems or something like
that, but, break those two things up to begin like one talks about
products and then we talk about systems and I agree there needs some
work on that sentence because that\'s now not a sentence, but, \--

UNIDENTIFIED MALE: Do we need the sentence at all?

DR. SCHECHTMAN: Can I actually just respond to one thing about Greg\'s
\-- now, it\'s a shame that Jim is not here. He would probably know the
answer to this better than I do, but, at the point when one of these
things becomes an actual product and it becomes a manufacturing \-- and
the growth of it becomes a manufacturing process I\'m not sure at what
level FDA might not actually be involved in looking at those.

USDA obviously will, but, I\'m not sure exactly the level of the
handoff.

DR. JAFFE: There\'s something that\'s put out that suggests that at the
stage when there\'s a \-- to the extent that the field is a
manufacturing facility then they will have operating procedures and
other kinds of things.

MR. DEMORGAN: Can I just request that or suggest that, Pat, I understand
that you want to make some changes, but, we were trying not to edit \--

DR. LAYTON: Right, and I\'m not.

MR. DEMORGAN: \-- and strike out.

DR. LAYTON: What I\'m trying to say is I think that two lines needs work
and we can work with FDA to get the right wording there.

MR. DEMORGAN: So the concept here was, you know, limit to crops and not
derived products was what the gist of it was.

DR. DYKES: I think we also have a suggestion that perhaps ending it at
benefits and we don\'t need those next sentences.

DR. LAYTON: So, don\'t need that at all.

DR. DYKES: Just stop with benefits and then pick up with however.

DR. LAYTON: Okay. Good.

MR. DEMORGAN: Is that okay with folks?

DR. LAYTON: Okay. So, this is a lot shorter.

DR. DYKES: Yes.

DR. LAYTON: Does that bottom sentence need to be in italics? I\'m trying
to ask and find out if that\'s a recommendation or not?

DR. SCHECHTMAN: We\'re not there yet.

DR. LAYTON: Okay.

MR. DEMORGAN: So, Greg, I think \-- did you have any more comments? Your
card is still up.

DR. JAFFE: Yeah. I guess for the sentence that starts with some of those
concerns, I don\'t have a proposed suggestion at this point, but, I
think that sentence needs to be rewritten and explain much better what
the concerns are of the people who have those concerns.

MR. DEMORGAN: Okay.

DR. JAFFE: I don\'t know what it means by heightened public emotions,
especially when we talk about, here we say that the concerns are safety
concerns.

We say I\'m not satisfied they meet the requirements of safety and
integrity of the food supply and proper containment. We don\'t go into
those which are perceived liability and heightened public emotion. So, I
think that that \-- and I\'d be happy to work with Carol and others to
come up with language. I don\'t have that language here, but, I think it
should better reflect the safety concerns.

DR. VAN EENENNAAM: I do have one. Outside concerns range from liability
and commercial risk in maintaining continued consumer confidence in the
safety of the food supply. I don\'t know if that works. It\'s
underlined.

MS. TUCKER FOREMAN: I think the \-- I think the \-- I\'m sorry.

MR. DEMORGAN: If it\'s on that specific suggestion. Josephine, are you
on the specific thing that Greg had?

DR. HUNT: I\'m on that specific sentence, yes.

MR. DEMORGAN: Go ahead.

DR. HUNT: Because I think as well as the safety and things that\'s just
being discussed by Alison\'s sentence, brand reputation and I think
would cover what aspect.

DR. DYKES: Is that commercial reputation?

DR. HUNT: Yes. I\'ve got \-- I mean, as well as commercialism and brand
reputation.

MR. GRANT: Which is different than?

DR. DYKES: That\'s different from commercial risk?

DR. HUNT: Yeah.

DR. LAYTON: If you\'re Kraft Foods it is.

DR. DYKES: I\'m not arguing. I\'m just saying is impact on brand
reputation and sub-set of commercial risk?

DR. HUNT: I would say brand reputation is a bigger thing.

UNIDENTIFIED MALE: If it\'s your brand.

UNIDENTIFIED MALE: If that\'s what the risk is.

DR. DYKES: See, to Kraft, that is the commercial risk is the impact on
brand reputation.

DR. HUNT: Unless we just say and brand reputation.

UNIDENTIFIED MALE: You could say commercial risk including brand
reputation.

DR. HUNT: Yeah.

DR. DYKES: I think commercial risk is a whole bunch of different kinds
of things.

DR. LAYTON: Some people have no names.

DR. HUNT: True.

MR. DEMORGAN: So the suggestion is that this sentence that Alison wrote
replace the sentence that says some of these concerns, the whole
sentence? Okay. So, strike some of these concerns and that\'s what
replaces it. So, put proposed. Carol, on this?

MS. TUCKER FOREMAN: I\'m sorry, which one?

MS. SULTON: That\'s what was replaced.

MS. TUCKER FOREMAN: I think we should say what people are worried about.

MR. DEMORGAN: Yeah, I know, look at the red lines though. It\'s really
just a reorganization.

MS. TUCKER FOREMAN: It doesn\'t say people are worried that there are
going to be prescription drugs in their breakfast cereal. You know, you
can\'t just say heightened public emotions. What is it people are
worried about?

DR. LAYTON: She took that out.

MS. TUCKER FOREMAN: No, but, it doesn\'t \-- I\'m missing it if it says
people are worried that there will be prescription drugs in their
breakfast cereal, in their food supply.

UNIDENTIFIED MALE: I think it\'s a typo, I don\'t think it\'s the
breakfast cereal.

MR. DEMORGAN: So, the language that Alison wrote is up there. And where
it\'s addressing consumer needs is to maintain \-- you know \-- concerns
range from x to maintaining continued consumer confidence in the safety
of the food supply. You\'re proposing that you replace that with their
concern about pharmaceuticals in their cereal?

MS. TUCKER FOREMAN: Or, for example, that there might be. That\'ll work.

DR. LAYTON: So comma, a safe food supply, comma, such as.

MR. DEMORGAN: Comma.

DR. LAYTON: Consumer confidence in the safety of the food supply.

MS. TUCKER FOREMAN: Such as

DR. LAYTON: Comma such as.

MS. TUCKER FOREMAN: It doesn\'t read very well.

DR. LAYTON: Just period. Another sentence.

MR. DEMORGAN: Okay. Concept. Pharmaceuticals in your food.

MS. TUCKER FOREMAN: Yes.

MR. DEMORGAN: Okay. So, to incorporate. Carol?

DR. CRAMER: The first line, I didn\'t think I had a constituency but I
actually do. You work on plant-made pharmaceuticals with an effort to
really bring real solutions to medical problems in a way that is focused
on the integrity and safety of the food supply. And this is inflammatory
to me. We have to figure out other language. This is not acceptable.

MR. DEMORGAN: So, it\'s a concept now, not a specific thing. So, you
have serious concerns with that example.

DR. DYKES: That\'s a specific thing. Pharmaceuticals in your food is a
specific thing.

MR. DEMORGAN: Right.

DR. CRAMER: This is a fear-mongering statement.

MR. DEMORGAN: Just let me clarify what I was trying to say. The word
concept right here doesn\'t indicate that it\'s in \-- that word\'s not
going to stay there. It indicates to Pat that she needs to work that in.
Good luck. And what you\'re raising is, and that\'s fair, that\'s great,
you\'re raising a concern with that being an example in this situation.
So, what Carol wanted to respond and \--

MS. TUCKER FOREMAN: You know, I think this is one of those cases where
you can say, and, in fact, we had said up above that the creation of
these plants holds real potential for serious medical benefits. The flip
side of that is that we\'re having trouble because I hear that I might
end up with a prescription drug in my food supply. I think what I\'m
saying is just as true as that initial statement. It\'s a reality.

The reason that the food processors and the grocery manufacturers filed
comments over here urging that USDA not approve the use of food products
for the growing of pharmaceuticals. Now, it\'s not me, that\'s Ron and
his guys, is that they fear this will happen. They said it\'s a
commercial problem. Frankly, I think the more important issue is that
consumers fear that it will end up in their food supply.

So, I think it\'s just the simple other side of the fact that we all
acknowledge that there\'s potential benefit here. It would be better,
you know, if we could go on to something besides corn, but, \--

MR. DEMORGAN: Okay. So, what we did up here in the concept was just,
again, it\'s conceptual. It\'s, for example, while pharmaceuticals will
benefit lots of farmers, there\'s concern it will end up in the food
supply. So, it might be linked. So, it\'s a concept. Alison \--

DR. JAFFE: The benefit one\'s up there already in the first sentence. It
should not be put in that sentence.

MS. ZANNONI: Can that sentence go in there that starts with however?
Because it has the safety \-- the issues about into the food supply.

DR. CRAMER: They\'re still there.

MS. ZANNONI: So, \--

MS. TUCKER FOREMAN: It\'s not a safety issue. It is \--

DR. LAYTON: It\'s safety, commercial, and emotional concern.

DR. SCHECHTMAN: Consumer.

DR. LAYTON: And consumer concern. It\'s safety, commercial, and
consumer?

MS. TUCKER FOREMAN: We\'re not going to be able to work this out right
here because it\'s my view that when you say this is a specific benefit
that one that is also a specific risk that we should be as specific of
the risk as we are about the benefit.

MR. DEMORGAN: But, right now, I mean, I think this is a fair point and
maybe we could just leave it to the person who is going to rewrite it,
but, if you look at the sentence, especially the way that Alison rewrote
it above, it says the potential of assessed products, although never
intended for consumption as food, might inadvertently enter the food
supply, which is the point you\'re raising, raises safety and commercial
concerns.

Then this next sentence was attempting to give some examples, but, do
you need to give those examples, I guess, is the question. You just \--
so that\'s \--

DR. VAN EENENNAAM: I would argue that the consumer confidence in the
safety of the food supply is addressing Carol\'s point. I know you and I
are going to disagree on that, but, I mean, we haven\'t really listed
specific benefits up there. We say could have substantial health and
economic benefits and then we acknowledge that consumer confidence,
which is really what that\'s potentially \-- you know \-- if you\'re
worried about something in your cereal that\'s really what you\'re
talking about, that\'s acknowledged too and, so, I don\'t think either
of them go \-- you know \-- it\'s going to cure cancer or you\'re going
to have something bad in your Wheaties^®^. I think both of them are
moderate and both viewpoints are represented.

So, I guess I can tell Carole Cramer that that example is very specific
and very scary.

MR. DEMORGAN: Okay. And it is, as you say, inadvertently entered the
food supply. All right. So, Carole?

DR. CRAMER: I guess I would just point out that just to reinforce it,
the concept of pharmaceuticals in my cereal is not necessarily a safety
risk, unh-unh. We haven\'t \-- that hasn\'t been addressed in any way,
shape, or, form. This is \-- I mean, what Carol\'s talking about is
actually a perception and it actually \-- we captured it in the concepts
of brand integrity and consumer confidence.

But, we really are not \-- I mean, I\'ll go back, and I brought it up a
number of times. We drink milk because it\'s full of antibodies but yet
a plant with an antibody is somehow, you know, really dangerous. We have
to really be careful about how we word this.

MS. TUCKER FOREMAN: Okay. I think we\'re not going to settle it now.
Being careful is having the effect of being more specific, I think,
about benefits all the way through than we are about what bothers the
public. I think this is not a safety issue. I think it is, however, an
important \-- it may be a safety issue so you got to have it there. I
think it goes beyond that. It goes to people\'s concern that there\'s
going to be something in their food that they don\'t want to have.

They didn\'t buy it to get that and they don\'t want it.

MR. DEMORGAN: Okay. So, I guess I would say just ask that we think
we\'ve got this one flap, we\'ve got it flagged out. Some people, and I
think as you see the edit, a lot of it already may be there and when
Carole sees it and Carol sees it they may both be comfortable. But,
we\'re not going to mix in both that way. Greg may not, but, that\'s
okay.

DR. JAFFE: I mean, I\'m going to agree with Carol Tucker Foreman here
and I\'m going to raise what I raised before which is if we\'re going to
have issues that say some say this or some say that there has to be some
deference to the people who have those opinions to identify and describe
those the way they want to describe those and I think what Carol\'s
saying is that she\'s willing to let other people describe what they
think these are \-- the benefits to this when someone else may not think
that, but, if there\'s a concern I don\'t want my concern to be
wordsmithed to it be not my concern anymore and that\'s what I think
somebody\'s trying to do here is take what we think \--

DR. LAYTON: And what I\'m going to ask you to do, Greg, is I\'m going to
have a few days before I\'m going to send you a new draft out and if you
think \-- I really \-- you know \-- if you\'ve got words that are
appropriate please, please send them to me and I will put them in for us
to all look at if we can, even if I have to bracket them, but, at least
it will be there for concern. I\'ll try to do my best.

And I\'m simply saying, and I think that\'s the only job you all got to
do, but, I can\'t say \--

DR. SCHECHTMAN: We can talk about the issues.

DR. LAYTON: We can talk about the issues, but, I can\'t \--

DR. SCHECHTMAN: These general issues.

DR. LAYTON: Let me just finish. If we don\'t want somebody else to write
it for us on the general issues.

DR. JAFFE: I\'ll just give you language. I sent you something on
language before.

DR. LAYTON: And that\'s what my thing is, if we\'ve got an issue then
you\'ve got to give me word. Okay. I agree with your issue. I just have
to have real words. Carol?

DR. CRAMER: I mean, I think there\'s a compromise here which is I\'m
bothered by the concept of bringing examples up that link it with safety
and risk. There is a real issue which is that because we\'re using human
genes and animal genes in food products there are different concerns,
so, there\'s a public \-- a greater consumer concern that is not
science-based necessarily, sorry to do that, but, really is this
fundamental relationship to food.

I think that it\'s okay to have a sentence addressing that because that
is something that is important to bring to the Secretary\'s vision and I
think \--

MS. TUCKER FOREMAN: I think you have done a better job at addressing my
concern than I did and that we can probably work out the language \--

DR. CRAMER: Right.

MS. TUCKER FOREMAN: \-- because that\'s going to come up.

DR. CRAMER: The real thing is, there are issues with safety. We want to
look at the issues of safety and containment, but, this is something
special because people feel differently about this and that\'s okay to
say. As long as we pull it out in a way that reflects that.

MS. TUCKER FOREMAN: I do.

MR. DEMORGAN: So, maybe Carol and Carol could get together and work on a
little language to send to Pat. Would that \--

MS. TUCKER FOREMAN: Well, I can\'t do it at four o\'clock. I\'m sorry.
I\'m getting crunched here, but, Carol, \--

MR. DEMORGAN: Okay.

MS. TUCKER FOREMAN: We\'ll do it. We\'ll do it.

MR. DEMORGAN: So, Michael wants to say, I think, something about
processing.

DR. SCHECHTMAN: Yes.

MR. DEMORGAN: And we can kind of look at the clock and figure out where
we are.

DR. SCHECHTMAN: I mean, I think what this discussion just did was
actually demonstrate what I hoped would happen. Rather than having
specifically \-- I mean, I think if one side on a particular discussion
says I need to have a lot of deference on my way of saying this at the
end we get to a point of people saying I can\'t live with this. It may
get to the point of people saying I can\'t live with this document. And
I think this example of where people said, okay, we can find a solution
where someone on the opposite side of the debate says that you said it
better than I did, I think that\'s precisely the kind of things we want
to see happen.

And sometimes that\'s easier than \--

MS. TUCKER FOREMAN: I don\'t believe that will be possible in all of the
cases.

DR. SCHECHTMAN: Okay. I think that you\'re probably right, but, I think
that it behooves us to try before we have to move off of \-- you know
\-- and it\'s exactly what happened here.

MR. DEMORGAN: So we have an agreed upon topic statement in this
instance. We have a recognition of the different perspectives here and
you\'ve basically been asked to \-- Pat\'s asked to give her a chance to
redraft it in a way that hopefully meets your \-- we\'ve got 14 more
issues that this may not work. It just may not.

MS. TUCKER FOREMAN: I got a process just to tack on there.

MR. DEMORGAN: Sure.

MS. TUCKER FOREMAN: I think Greg\'s point\'s very well taken, though,
that initially when there is one of these we think this and somebody
else thinks that that the language used there ought to be the language
that the person\'s who voiced that particular point of view and then we
work to a compromise from that if we can.

DR. LAYTON: And I will look to you all now, and you, meaning every one
of us here, if you would look in the document ahead of time because we
will not get to all of them today, and send me that I will make a note
from Greg, from Carol Tucker Foreman, or, from Ron, if it\'s the
industry side or if it\'s, you know, the animal side, whatever side it
is, if we\'ve got it in there, and I don\'t remember all of them right
now, I\'ll put it in there and that will give us the discussion step off
point.

Michael?

DR. DYKES: I hear you and I appreciate the direction you\'re going in.

DR. LAYTON: I\'m just trying to keep everybody happy.

DR. DYKES: Well, that\'s not possible.

DR. LAYTON: No.

DR. DYKES: But, I just think sometimes it\'s hard to go ahead and look
at these things now and anticipate where those are going to be because
so much of the time by and large most of all of them with the
conversation we come up with something that we can all kind of get
behind. So, I think at the end of the day rather than try to go ahead
proactively and look at those things there will be very few of those I
would think that we\'re going to come to. But, that\'s being optimistic
perhaps.

So, I\'d rather us have the conversation and then clearly identify where
we need to go away and work on rather than anticipate.

DR. LAYTON: Okay. Let me suggest this. One of the things we can do is at
least if you can pick out those spots where we need to have those
conversations to get to this point we are going to have to have a series
of work group conference calls that at least they would be flagged for
having that specific discussion during that \-- during a conference call
in which that issue is discussed.

So, I at least need \-- I\'m thinking if you\'ve got a sensitive area
that especially is some think one way, some think another way, I just
want to make sure we pay attention to that discussion and that the
appropriate people are in that discussion.

For example, when we\'re scheduling a conference call if it\'s a
consumer issue then I\'ve got a consumer on the phone call. Does that
make sense? We\'re all consumers, but, I mean, Carol.

MS. TUCKER FOREMAN: Some of us have that as our primary concern. It\'s
true, but, just for the record, the last call was scheduled not in
consultation with anybody except the work group which was appropriate,
but, I couldn\'t be on it.

DR. LAYTON: I totally understand, Carol, and that\'s why I say I want to
make sure if you\'ve got an issue that you\'re one of the people that we
make sure we get in on the call. If it has to do with scheduling,
absolutely.

MR. DEMORGAN: So, you know, one of the challenges from a process
perspective is if you put agreement in finding that middle ground as
your objective that\'s very different than your objective being he
said/she said or they said/they said because if you\'re going for that
pathway, you know, it\'s much easier to just say, you know, let\'s not
work that hard and as the time crunch comes on you it\'s going to be
even easier to go that way.

So, I do think that it\'s what Pat\'s basically said and you need to
identify the topics that you think \-- so far, this is the first one
where you\'ve even got the inkling of a he said, or, they said, the
other person said, and even then it looks like there may be some common
ground to get the language that works. But, I do understand from having
other conversations during the next 14 you\'re going to find a few that
it may not be worth the four hours or eight hours it might get to that
watered down statement at the very end and one could live with.

So, from a timing perspective, it\'s a quarter to three and it\'s later
than that.

DR. JAFFE: That was my point though. I mean, I\'m happy to work on
compromise, but, a watered down statement is not suggesting what the \--

DR. LAYTON: That\'s what I\'m saying. There may be those issues where
it\'s not worth giving your time on.

DR. LAYTON: But, it\'s also not a watered down statement.

DR. JAFFE: That doesn\'t do the Secretary benefit to have a watered down
statement because it doesn\'t then address to show the difference of
opinion. If you have to get the watered down statement then I don\'t
think it\'s valuable.

MR. DEMORGAN: Right, I agree.

DR. JAFFE: Okay. I thought you were saying even if we do it in one hour
I\'m saying I\'m not sure it\'s worth the watered down statement.

MR. DEMORGAN: Okay. Thank you. Okay. So, I guess the process question at
this point is there are 14 more issues to talk about. Now, you talked
about all of these. I think there\'s one of them that\'s the labeling
and the other report issue. It strikes me you could spend another 15
minutes talking about issue number 15; maybe another 15 on 16; and then
you\'d have to go into your work plan conversation about what are you
going to do between now and then.

I guess the proposal, and I\'ll look to Michael and Pat and Cindy here,
is just wouldn\'t it be worth just going through the other 14 and just
flagging kind of is this one of these types of issues that\'s going to
need a different level of approach that you need to talk about very
briefly, or, I\'m not sure what you do because you\'re not going to get
to all of them.

DR. DYKES: I\'m not following what your thoughts are.

DR. JAFFE: Go ahead.

MR. DEMORGAN: It just sounded like Michael or Carol, I\'m not sure, was
suggesting there was some issues out here. Maybe you all know what they
are, but, they\'re going to be of this something going one way,
something going the other, and it would be useful to just flag those and
pull those out right now. But, maybe, if that doesn\'t make sense,
that\'s fine.

So, are we ready to move on to issue 15?

DR. JAFFE: Is our work plan we\'re going to talk about next, proceed to
the next step until about 3:15 or 3:30? Is that the \--

MR. DEMORGAN: Yeah, right. We\'ll take a break probably after this
number 15 and then come back unless you want to take a break right now.

DR. LAYTON: Let\'s wait until 3:30. If you need a break jump up and go
or go get a drink.

MR. DEMORGAN: So, who\'s leaving before four? Who\'s leaving before
3:45? Just Carol. Okay. And when are you leaving, Carol?

MS. TUCKER FOREMAN: I need to be gone by 3:15.

MR. DEMORGAN: 3:15, okay. So we need to have the work plan conversation
with you here?

MS. TUCKER FOREMAN: I don\'t want to inconvenience people, but, it would
be real nice.

MR. DEMORGAN: So, \--

DR. LAYTON: Let\'s do the work plan conversation.

MR. DEMORGAN: And then when we\'re done with that cycle into \--

DR. LAYTON: Issue 15.

MR. DEMORGAN: \-- issue 15 and 16 until four o\'clock. Why don\'t we
take just a \-- I would suggest a five minute break right now.

(Whereupon, a brief recess was taken)

DR. LAYTON: Okay. On the board or on the screen are \-- would be that
sometime between now and November the 4th I will try to get out to you
all a new version and what I\'m thinking of it\'s not table format,
it\'s just a document with \-- to show all the pieces that we\'ve done,
with sentences chopped up, where we\'ve done the edit, we\'ll do the
edit, and then meanwhile though the facilitators will start scheduling
conference calls in November.

Those conference calls and the introduction may actually be the last
conference call to be done, but, one group will be dealing with that
part T&L topics and with that part T&L topics I want to make sure to
have some people from the T&L paper on that conference call because
they\'re more infinitely familiar with what\'s in that paper than some
of us are who haven\'t read it in six months, but, since they wrote it
they probably remember it more.

Topics that we discussed in the last two days might be another breakout,
so, the 15 that we\'ve already had time to discuss would be maybe a
shorter group. And then topics not discussed today, again, might we \--
to get a smaller chunk of time we might need to bite those off in two
pieces. But, at least, so, we\'re talking four, possibly five,
conference calls with the introduction being maybe the last one.

Then what I would try to do is if we can do all those in November, redo
based on what we heard on this, conference calls, another draft out by
the 7th. After that draft goes back out you will then try to get your
comments back into me by the \-- you would get your comments, not try.
You will get your comments in to me by the 14th. And then I will try to
have them out early on the 16th but it might be later on the 16th of
December which is \-- you know \-- in the world, those last two weeks of
December nothing\'s going to happen so I want them out before you walk
away so you can print them out and carry them with you as you go to the
Bahamas and celebrate Christmas or whatever you\'re doing this year and
get your comments back to me \-- that\'s right, your comments are due
back to me by the 14th and I would then send it back out all tabulated
and done so you can think about everything that\'s in there by the 16th.

And then that will be the document then that we have by the 16th that
we\'d be working from with comments at our January meeting.

DR. HERDT: So, in January.

DR. LAYTON: In January 5th and 6th.

DR. HERDT: You have the 6th, final draft with comments. This is from you
to everyone.

DR. LAYTON: To everyone.

DR. HERDT: What comments are those?

DR. LAYTON: That\'s the comments that \--

DR. HERDT: Incorporated from the 14th?

DR. LAYTON: Right.

DR. HERDT: Gotcha. Okay.

DR. LAYTON: Incorporated comments or side-by-side comments.

DR. HERDT: Side-by-side, yeah, side-by-side.

DR. LAYTON: Yes, Greg?

DR. JAFFE: Can you go up a little higher, I can\'t see the whole thing.
But, I guess a couple of questions. One question I had was for the
conference call for the conference discussed today that would be after,
I assume, the draft comes out so we could be responding to the draft?

DR. LAYTON: I will have something to you by the 4th of November so after
the 4th of November, that draft. So, it would have whatever we\'ve done
today in it, yes, over the last two days.

DR. JAFFE: And I guess one of my recommendations would be there are
series of paragraphs on the introduction that clearly we parked because
of my suggestion. I would suggest that we get a small working group
together to actually draft something that would then be something that
could be reviewed on the conference call for the introduction that has
some volume from this group and a small group of people draft into an
e-mail or some form, but, to have something so that we\'re not \--
don\'t even scratch there, but, people who are interested in that to get
together and do that, especially if that\'s going to be the last
conference call in terms of the timing it would be advantageous in my
mind to have something for those paragraphs that need to be drafted by
more than just the Chair at this point.

DR. LAYTON: I\'d love for you to send me something. I\'m very happy \--
I\'m trying to remember which paragraphs you\'re talking about.

DR. JAFFE: Nine, ten, and thirteen. Those are the paragraphs that \--

DR. LAYTON: Ten, eleven, and thirteen.

DR. JAFFE: They all had \--

MS. SULTON: Greg, do you see a small, a couple of people getting
together to write that and submitting it to Pat as a draft that she can
use or do you see that as a facilitated conference call?

DR. JAFFE: If you want to do it as a facilitated conference call, I\'m
not talking about a whole work group. I\'m just saying that \--

MS. SULTON: Could get together and write something, right?

DR. JAFFE: Well, they\'re not going to get together physically and write
that so, no, the answer to that is no. A conference call would be the
way to \-- if you\'re talking about it in a way that get people together
to do it that would be a conference call.

MS. SULTON: No, what I\'m saying is it possible for a couple of members
just to initiate that and submit that that anyone might submit to Pat.

DR. SCHECHTMAN: I guess there\'s a little bit of process \-- there\'s
some process questions here. I know we have comments that exist on the
current text. We also have suggested alternate text for those paragraphs
that came in from Carol Tucker Foreman already. So, I\'m trying to
figure out whether the appropriate thing is to have a whole new version
of this text drafted or to have the people who \-- to have a work group
assembled who have all of the comments that may be submitted on those
few paragraphs by day x.

Maybe we need to set a special other date x to make sure that people
comment on those few paragraphs and we collate all of those comments,
Carol, the old ones, and any new ones that may come in, and that\'s what
is worked from in the conference call.

DR. LAYTON: Yeah. I was just going to do what we had to date.

MS. SULTON: We would have one document so we know what we have to date
as opposed to having the pieces and then that way we have the benefit of
the work that we\'ve done the last couple of days.

DR. JAFFE: I guess I was just hoping that \-- I mean, the Chair\'s done
a great job, but, I was hoping if we got a couple of the different \--
as opposed to the Chair trying to make sense of those and putting it out
sort of strawman for everybody else to look at, if a few of the
different interests got together and actually came to consensus on it in
a small way then when they got to the work group you would have some
people who had some ownership in that then presenting that we might just
save ourselves one step and what I think are potentials on some fairly
controversial paragraphs. That\'s all I was trying to suggest.

DR. LAYTON: I totally understand and I guess I\'m asking you, are you
volunteering?

DR. JAFFE: I\'m happy to be one of those people, but, \--

DR. LAYTON: Okay. But, can \-- you know \-- there is a deadline and
there is a timeline and, you know, you have to get \-- you have to find
out \-- we need to leave here with who and when.

MS. SULTON: Here\'s the thing. We need the comments back on that
introductory piece back to Pat in time for her to get that document out
on the 4th of November.

DR. JAFFE: No, that\'s not what \-- I\'m not suggesting these are
appropriated for November 4th. It would be submitted by November 5th or
November 10th for the conference calls or work groups which would be
later in November for the conference calls.

MS. SULTON: Right. So you would have the benefit of the November 4th
document. Okay.

DR. JAFFE: Right, so, I mean, this group would work well at working on
the rest of it. I don\'t \-- instead of Pat working on making a draft
somebody else would be making a draft of those and getting them out for
the work group to work up but I don\'t want to make any problems here so
\--

MR. DEMORGAN: So I think what I\'m just hearing is just that basically
Pat\'s going to do her thing by the 4th. She\'s going to make changes to
1 through 9 and 12 revision to capture a conversation that you all had
yesterday and this morning. And then she may look at 10, 11, and 13 and
propose some edits that track with some of the other conversations, you
know, terminology and stuff, etc. She\'s not going to spend a ton of
time reworking those things that you didn\'t have conversations on.

DR. LAYTON: And milieu has got to be in there somewhere.

MR. DEMORGAN: And that\'s going to go out on the 4th. Then before then
you will have already scheduled a conference call.

DR. LAYTON: You will be scheduling something.

MR. DEMORGAN: And anybody can initiate a conversation amongst a small
group of you in advance of that conversation and say here\'s some
thoughts, here\'s some ideas, or any individual could send out some
language in advance of that and say here\'s some thoughts.

So, I think Greg\'s only question is do you want to formalize that
process someway and flag now that three or four people are going to look
at that November 4th version and rewrite something, or, propose
something to the small group, or, just do it in a more *ad hoc* way
which could just be doing the exact same thing. Greg could call up Ron
and bill and Russell and say, hey, let\'s work on some language and
throw it out to the group.

Is that right, Greg, formalize it or not?

DR. JAFFE: It\'s all right.

MR. DEMORGAN: So, anybody want to join Greg formally right now saying
that you know as of the 4th you\'re going to do some work in advance of
the call or just keep it at an ad hoc level? So, Carol and Greg may work
on something.

MS. TUCKER FOREMAN: Greg and I will get together.

MR. DEMORGAN: Okay. So, it\'s *ad hoc*. Anybody can work on that
document in advance of the call like one would hope you would.

MS. SULTON: But we\'ll still have a work group on these.

DR. SCHECHTMAN: Let me just suggest that maybe we plan \-- maybe the
simplest thing to do is actually just to plan for two calls and we will
have \-- you know \-- maybe not everyone \-- maybe more people will be
interested in looking at it the second time around than the first time
around. They\'ll both be open-ended. We\'ll make sure at least there\'s
some balanced representation on the first call so we\'ll just go through
it that way if that\'s okay with everyone.

DR. LAYTON: On the introduction?

DR. SCHECHTMAN: Yeah. Does that make sense to work through that stuff
just so we can ensure that people who aren\'t inclined to always agree,
not that I\'m saying that people always agree, but, people \-- that
there\'s balanced representation of views, getting that new piece in for
everyone to discuss.

So, we\'ll just plan on there being two calls then.

DR. DYKES: So, by November 4th Pat\'s plan to have a rewrite of the text
\--

MS. SULTON: Of the whole thing.

DR. DYKES: \-- and anyone wanting to submit comments on 10, 11, and 13
can do so?

MS. SULTON: On anything.

DR. DYKES: On anything. Preferably prior to the November 4th do you want
views to be reflected by the Chair and the Chair\'s draft. If you don\'t
you\'ve not missed the boat. There\'s going to be conference calls to
discuss the whole thing.

DR. SCHECHTMAN: That\'s it.

DR. LAYTON: And you still get your crack at it on the 5th and 6th.

DR. DYKES: Yes.

DR. LAYTON: So, everybody can reserve their right.

MS. SULTON: So that means that you\'re going to hear from Kathy very
soon like maybe tomorrow or the next day asking for your calendars for
November and early December so we can schedule these things. Okay.
Carol, did you have something?

DR. CRAMER: Yes. I just think that one way to look at what Greg was
saying is that we\'re running out of time if the two calls between
eleven and four and one of the things we may look at is having for the
introduction group, the first call could be even before November 4 if
you\'re going to try to get two in, but, the first call would focus on
the one that wouldn\'t be incorporated in what Pat\'s doing, just
because getting people together might \--

DR. SCHECHTMAN: In other words, \--

MS. TUCKER FOREMAN: I didn\'t catch the tail end of what you said,
Carol. Would be focused on?

DR. CRAMER: I\'m just saying that if the first intro group was focusing
on those paragraphs that were not dealt with here then we may even look
at it sooner like next week.

DR. SCHECHTMAN: So, in other words, \--

DR. LAYTON: If you could do something and get it to me by the 4th that
would be great.

DR. SCHECHTMAN: If we could schedule a call for next week to work on
those few paragraphs. Can you just get a schedule to everybody out \--

DR. LAYTON: Between now and November 3rd.

DR. SCHECHTMAN: And I guess if we get \-- well, we guess we want to get
schedule information out for the whole time but the question will be I
know that Carol Tucker Foreman and Greg are interested in this. Who else
will be interested in getting it to the first round of discussion on
these paragraphs? I just want to see who.

DR. CRAMER: Why don\'t we just use the interim work group. We already
had them.

DR. SCHECHTMAN: We\'ll use the interim work group with Carol and try to
find \-- we will try to find a time next week when we can do this. The
call will also be open-ended so that if someone wishes to join in the
discussion next week we won\'t be trying to accommodate other people\'s
schedules for next week, we\'ll just be trying to accommodate the
schedules of the people on the work group plus Carol since she indicated
she wants to be there.

DR. CRAMER: She was on that.

DR. SCHECHTMAN: Was she on that? Yeah, that\'s right, she just couldn\'t
make the other call. Okay.

DR. SULTON: Okay. You\'re going to get started on all the schedules so
next week for the intro.

DR. LAYTON: And you\'ve got to get back to us quickly then.

MS. SULTON: And you\'re also going to get requested for your
availability throughout November and throughout December for the other
potential work group session. Okay. So we have a plan. Yes, Alison?

DR. VAN EENENNAAM: Are we going to be firm on when comments are due
back?

DR. LAYTON: Yes.

DR. VAN EENENNAAM: This time around? Because otherwise I\'ll just do it
here. I guess I feel like there\'s going to be a process. Either it\'s
due on the 4th or the 8th, or whatever it is, I forget exactly, but, are
we going to be firm on that?

DR. SCHECHTMAN: Let me just ask what you mean. If by being firm on it
you mean that \--

DR. VAN EENENNAAM: There has to be some sense \--

DR. SCHECHTMAN: Let me just finish.

DR. VAN EENENNAAM: I have a concern.

DR. SCHECHTMAN: Yes. If by being firm you mean that members will not be
allowed to make any comments at the next meeting that weren\'t written
down \--

DR. VAN EENENNAAM: That\'s not what I mean. It would be that if someone
has a concern, maybe like some of Greg\'s, I don\'t understand this
whole topic, it\'s written in here as such, and then if it\'s going to
be new verbiage or new paragraphs or new suggestion that would be
written in here too, so, that everybody has a time to read them, digest
them, think about it, instead of being faced with them on the 5th and
6th. Totally new words or ideas and, of course, there\'s going to be
discussion on each one, but, to give it some teeth.

Otherwise, I don\'t know why people would obey the schedule.

MS. SULTON: So you\'re suggesting that there won\'t be written things
handed out at the meeting but it is possible during that meeting people
will come up with solutions.

DR. LAYTON: Solutions. But you\'ve got to raise the issue in the table
type document.

MR. DEMORGAN: The only comment that I would make, Alison, I mean, what
you\'re doing is, in essence, legislating, which is fine, good behavior,
and you can only do that so much to an extent. I mean, everybody has a
responsibility to each other to get their comments in by the 13th and it
is at one level disrespectful to bring a whole written set of comments
the day of the meeting when everybody else submitted theirs.

However, you are working by consensus or at least striving to get to a
place where you can reach agreement for the Secretary. And, so, if
somebody does that it\'s hard to say absolutely not because they could
just read it. You know, I mean, it is one of the dilemmas, the problems
of this kind of process. So, I think the point is, and we had a big
illustration, we were get past it today because of Greg\'s good
suggestion, and I think the request to all of you is that you meet the
deadline, that if you\'ve got a major heartburn issue that it\'s on the
table, it\'s in the table that Pat sends out on the 16th so others can
call you, talk about it off line, think about a solution that maybe
works for them, or, say, you know, that\'s never going to work, we need
to find that coming in.

So, I think it\'s a very good statement, very helpful. I think
legislating it is challenging, but, you know, I think encouraging and
really requesting it of each other you respect each other and I think
that\'s a message that just needs to be sent out by the facilitation
team in the next e-mail and when Pat sends these out to say that.

Is that fair?

DR. VAN EENENNAAM: Yeah. I mean, it was half the group didn\'t do that
this time.

MR. DEMORGAN: Sure, exactly. Yeah, so, it\'s not just the fact that half
the group didn\'t written comment, so, clearly other people had issues
with these things and didn\'t have time.

Michael?

DR. DYKES: Yeah, I was just going to say I think it\'s part of the
process and I agree, I didn\'t comment on before either, but, I have
seen this process \-- I\'m guilty

\-- I have seen this process play out. So, when we run across this,
let\'s stay with the process, rather than get a new document handed out
here and we flip over and start talking about the new document. Let\'s
stick to the document we have at hand and if you want to bring in and
prepare your comments in writing so you can guide your discussion I\'m
fine with that.

But, to pass out two pages to all of us, this new text here today, on a
topic is all of us did that we\'d be shuffling papers here forever. I
mean, it\'s just not the belief that we\'re going to hold up for the
process.

DR. LAYTON: And, again, for the nine of you who didn\'t comment, you
know, to me that says I don\'t have substantive issues. Okay. And to be
respectful to each other if you have substantive issues that are coming
up you need to respect each other and you need to put those on paper so
that everyone knows they\'re coming and we can think about them and be
ready to present solutions.

We have not got very long to get to a document that\'s in good enough
shape to come to a vote on or to come to a sign-off point on. Because
we\'re ready to get ready to do the next set of work and I\'m anxious
and happy to do the next set of work, but, we\'ve all said we\'re going
to do this and we\'re going to do it quickly. We said that in March. We
said that in August. We\'re saying it again.

MS. SULTON: Okay. Very quickly, are we ready to do a couple of more
topics?

DR. VAN EENENNAAM: Yeah.

DR. DYKES: No. Are you going to send this \--

MS. SULTON: You\'ll get a next steps memo after this.

DR. DYKES: By when?

DR. LAYTON: Tomorrow. I can take this and send it out by e-mail
tomorrow.

DR. DYKES: The reason I\'m asking, so much of the time we\'re going to
give it and it takes a while and \--

DR. SCHECHTMAN: The next steps memo we\'ll get out within a couple of
days just to be \--

DR. LAYTON: I mean, I can send out what I\'ve got tomorrow to all of
you, remind you, and then the official next steps memo then may come out
later from Michael and then you will see, hopefully, tomorrow from Kathy
a calendar.

DR. DYKES: The reason why I ask why, and I\'m not trying to be
persnickety, but, if we\'ve got that on e-mail if you just send it to us
so then we don\'t have to call.

DR. LAYTON: Right.

DR. CRAMER: Could I also Michael to put on that to ask people to submit
their application if they want to continue on that timeline of next
steps for those of us who need it, a 2x4 to get our attention.

DR. LAYTON: When are they due?

DR. SCHECHTMAN: They\'re due November 14th. Yeah, November 14th.

DR. LAYTON: Can you please add November 14th.

MS. SULTON: New applications.

DR. LAYTON: Applications for \--

MS. SULTON: Reappointment.

DR. LAYTON: \-- reappointment.

MS. SULTON: Okay.

DR. SCHECHTMAN: Actually, on that point, just one little comment. I
would appreciate if there are members who are not going to reapply whose
terms expire if you would let me know that just to sort of aid in our
thinking about what\'s happening in the future. You know, obviously we
haven\'t gotten many applications yet and we\'re waiting for anything
like decisions on anything, but, it will help us in our planning to
understand who is not planning to resubmit their nominations.

DR. LAYTON: Yeah. Somebody\'s got to choose the one. Just kidding.

MS. SULTON: Okay.

DR. LAYTON: Okay. 15.

MS. SULTON: Topic 15 which presently reads new modern agricultural
biotechnology products, whether produced in the United States or
imported, will challenge the abilities of the U.S. regulatory system to
deliver careful, efficient, and coordinated evaluation of novel
products.

We have comments from Alison, from Bob, from Josephine, and from Greg.

DR. LAYTON: And from Mardi.

MS. SULTON: And from Mardi. Some of the questions that were brought up
more specifically by Mardi who is not here, whether the existing
framework \-- kind of a statement that the existing framework is not
ready for novel products.

Questions from Greg about, how are we defining novel? Let\'s start with
the statement. Other than the fact that we\'ve agreed that we\'re going
to lay out United States is there any other thing?

Michael Dykes?

DR. DYKES: Yeah. I\'ve asked the question. Isn\'t this identical to the
other one we did? Not similar or close to, but, isn\'t it identical to
the last one we just did?

MS. SULTON: 14?

DR. DYKES: Yes.

DR. SCHECHTMAN: To 9?

DR. DYKES: I don\'t know.

DR. SCHECHTMAN: You mean the one about new techniques?

DR. DYKES: Yeah, about new products in the system, coordinated,
efficient, get all the words, but, I think they\'re even the same words.

DR. LAYTON: The one that Daryl said these are the same. I remember that.

DR. DYKES: We went through this issue unless there\'s something about it
I\'m missing.

DR. LAYTON: Greg?

MS. SULTON: Wait a minute. Alison had hers up first and then Greg.

DR. VAN EENENNAAM: Yeah. I guess I see it as a combination of two
previous issues, one of them is how we handle the RNAi-type products and
then one\'s how to handle the imported stuff, but, then I think there\'s
also the issue of domestic things that are coming through and, so, it\'s
\--

MS. SULTON: I will mention as a point of topic that we said we weren\'t
going to set them up at this point. Greg?

DR. JAFFE: I think there are three issues. The issue, which we discussed
earlier today, and the new issues were the issues that Brad Shurdut
addressed which is products are going to be imported in the United
States and there we\'re talking about not just organisms but also
finished food products. And as our system \-- he wanted to give a
heads-up, I think, which is what he said at the last meeting that the
government needs to be really thinking about how those are going to be
playing into the regulatory system and that was a specific thing to the
fact that biotech research is going on in other parts of the \-- biotech
research is going on in other parts of the world.

The issue is that we discuss at the end of the new issues on the RNAi
silencing dealt with non-genetically engineered, the non-transgenic
things and how do biotechnologies... This one, my reading of it is it\'s
talking about, and that raises my first question is when we\'re talking
about agricultural biotechnology products here, I\'m substituting
transgenic, so, a new and novel transgenic products that are
domestically produced.

So, it\'s slightly different than the other two.

DR. LAYTON: You could certainly craft it to where that would be the
case. We certainly crafted item number 1 this morning to be imported
into the U.S. That certainly was crafted that way and the last one we
worked was definitely crafted to be non-transgenic and, so, Greg\'s
proposal is is that we craft this to be new or novel transgenic
domestic. Correct?

DR. JAFFE: Right. My question is whether \-- this says new and novel,
not new or novel.

DR. LAYTON: Oh, sorry.

DR. JAFFE: So, the question in my mind is, I\'m not sure what we mean by
novel. I understand what we mean by new and, so, new means anything we
don\'t have today. I\'m not sure what we mean by it has to be new and
novel. What is that? How are we defining that? Does that mean does
things that aren\'t BT technology and herbicide resistant and virus
resistant, or, are we talking about something broader than that?

DR. LAYTON: Daryl and Duane.

DR. BUSS: Not to define it, but, my recollection of this historically is
that this arose out of a discussion about products being novel in the
sense that they were very unusual they might well fall through the
cracks of regulation by different \--

DR. LAYTON: The fish. Glowfish^®^.

DR. BUSS: Well, that was one that sort of drove the discussion. So, I
don\'t know that we defined it, but, that\'s how this evolved has I
recollect it at least.

MS. SULTON: And that goes with Mardi\'s point too in her comments.
Duane?

MR. GRANT: Actually, I was going to agree somewhat with Mardi\'s
comments that new really isn\'t the issue. We\'ll have new things all
the time. As long as new fits within our framework they\'ll pass through
the system. It\'s the novel things such as Glowfish^®^ that are the
issue. So, I would agree with Mardi\'s edit.

I do have a question whether, I guess, whether \-- \-- produced in the
U.S. are imported. I think that is extraneous to the issue statement.
That should probably be deleted.

DR. LAYTON: So, Mardi\'s thing would then read, novel agricultural
biotechnology products will challenge the abilities of the U.S.
regulatory system to deliver scientifically sound, efficient, and
coordinated evaluation. That would be her edit based on your consult
there.

MS. SULTON: And it was previously suggested that we say transgenic.

DR. LAYTON: New, novel, transgenic organisms and their products.

MS. SULTON: So, this will do?

DR. SCHECHTMAN: No. Will challenge.

DR. LAYTON: Will challenge the abilities of the U.S. regulatory system.

MS. SULTON: The whole clause is gone.

DR. CRAMER: It\'s not agricultural.

MS. SULTON: No, it\'s transgenic. But, now we\'re saying transgenic
organisms and their products.

DR. LAYTON: Will challenge the abilities of the U.S. regulatory system.
Deliver scientifically sound, efficient, and coordinated evaluation. And
we talked about this.

MR. DEMORGAN: Did you want me to add scientifically sound?

DR. LAYTON: That\'s what Mardi\'s edit says. So, I was reading Mardi\'s
edit because I thought I heard Greg say or some say they liked Mardi\'s
approach.

MS. SULTON: Okay. Greg and then Michael.

DR. JAFFE: I mean, I\'m comfortable with scientifically sound. I would
say scientifically sound and efficient evaluations. I\'m not sure about
the coordinated aspects of it.

DR. SCHECHTMAN: If more than one agency is involved.

DR. LAYTON: If EPA and somebody else wanted to get involved. It just
solves the jurisdictional issue. We don\'t need to answer the
jurisdictional issue here is what I think they were trying to avoid.

DR. DYKES: Probably the Coordinated Framework.

DR. LAYTON: Huh?

DR. JAFFE: I understand, but, I don\'t necessarily buy into the
Coordinated Framework so I\'m not \-- I don\'t see that it needs to
happen so \--

DR. LAYTON: So you\'re saying efficient is going to include that?

DR. JAFFE: It may be efficient through one agency. It may be efficient
through multiple agencies whether they\'re coordinated or not.

DR. DYKES: Yeah, I see what you mean.

DR. LAYTON: Okay. So, scientifically sound and efficient evaluations.

DR. DYKES: I\'ll just ask a general question. As it reads now then
we\'re making a statement that novel transgenic organisms and their
products are going to challenge the capabilities of the U.S. regulatory
system?

MS. SULTON: That was the statement that Mardi was proposing.

DR. LAYTON: And I think that\'s what we said the Glowfish^®^ did.

DR. DYKES: I don\'t think we can just \-- I mean, they may not. I don\'t
think we can make that \--

DR. LAYTON: May challenge?

DR. DYKES: Yeah.

DR. LAYTON: Okay. May challenge.

DR. DYKES: And somewhere we\'ve got to spend time talking about it, but,
I think we\'ve got to key out what some things we have in mind here that
may do that.

DR. JAFFE: Give some examples of novel, some definition.

MS. SULTON: Well, should we maybe just note for concern that we should
put some examples in here?

DR. SLUTSKY: Well, it\'s vague enough right now that I\'m not quite sure
from \--

MS. SULTON: What it means.

DR. SLUTSKY: \-- what we read, you know, what you are asking.

DR. DYKES: Rainfall may alter U.S. production.

DR. JAFFE: But, our scope is not then pets and animals or insects. It\'s
been terrestrial animals and \--

DR. DYKES: Livestock.

DR. JAFFE: \-- plants. Livestock. So, it hasn\'t \--

DR. SLUTSKY: Or USDA.

MS. SULTON: Bob, do you have a suggestion?

DR. HERDT: Well, we are talking about \--

MS. SULTON: Could we just use our cards again.

DR. HERDT: We\'re talking about developments of products that haven\'t
been anticipated so I think that\'s why it\'s vague. This is novel
things that haven\'t been anticipated. How are you going to give
examples?

DR. JAFFE: Just say the regulatory \-- I was thinking about that what
Bob just said.

DR. DYKES: Things for which are not anticipated may cause challenges to
the system. We\'re soothsayers now.

DR. LAYTON: Glowfish^®^ did.

MS. SULTON: Alison?

DR. VAN EENENNAAM: We were just having that discussion about, you know,
this is agricultural biotechnology and, you know, like I think
transgenic pets do pose a regulatory challenge and I think they
somewhere probably do fall under what we\'re talking about, but,
they\'re not agricultural. I don\'t know, maybe a sheltie that\'s a
better herder or something would be agricultural, but, you know, and I
think a lot of people, at least in my state, are worried about
transgenic pets and, so, \--

DR. LAYTON: Whoa, whoa. Agriculture includes the entire U.S. Forest
Service and all public forests in the nation so if a dog came in and
could cross-breed with a wolf and that would have an impact on the deer
population of the United States that affects USDA, I think.

I mean, I\'m going to give you the rare, extreme example, but,
agriculture is not row crops.

DR. DYKES: That\'s what I had in mind when I said that.

DR. LAYTON: But, I\'m just saying, but, I think you have to get off the
fact that agriculture is row crops. Agriculture is not just row crops.
The USDA has a very broad responsibility that is not row crop and animal
systems, and production animal systems.

MS. SULTON: Okay. With that vision in mind, Daryl?

MR. GRANT: I just want to raise the point too that we have to be careful
by equating pets with dogs and cats because the growth of 15-20 acre
farm-ettes and three cows that are pets is a hugely increasing part of
the landscape and nobody quite knows what to do with them as agriculture
production or not. But, they are pets in many cases and their owners
would have many of the same desires as the owner of a Great Dane. So,
before we divorce pets too quickly I find this pretty blurred.

MS. SULTON: So is the issue that these animals might somehow affect
those animals that are a part of the food chain or is that what the
issue is?

DR. VAN EENENNAAM: I think it\'s just regulating. Are you going to have
to be regulated.

MS. SULTON: But, the reason we care?

DR. VAN EENENNAAM: Well, you have to ask the people. You know, I don\'t
know what a hypoallergenic cat might do, a breed or something. It\'s
just is there regulation for pets or not, are they covered or not?

DR. LAYTON: Duane?

MR. GRANT: I guess the question is, why do we care about the cat and why
do we want to address them in this? I would suggest that we probably
need to define what we mean by novel. If you leave it undefined it\'s
the universe of possibilities. It\'s science fiction, you know. Novel to
me would be any product that has either direct or indirect impact on
agriculture and does it clearly fall within the Coordinated Framework
that regulates biotechnology today. That would be my working definition
of a novel product.

MS. SULTON: So we have a proposed definition for novel. It was actually
requested in Daryl\'s comment.

DR. SCHECHTMAN: Can I ask one \-- just one follow up question in terms
of novel things? Are there things that are kind of organisms where we
might anticipate novel things where we\'re apart from possibly Bossie
and Elsie where we think USDA might very well wind up needing to be
involved and it would be relevant?

MS. SULTON: Carole?

DR. CRAMER: Maybe some horticultural crops that are transgenic but then
are initiated in lawns or yards or somewhere. Is that currently
regulated?

DR. SCHECHTMAN: But, those would certainly be regulated as transgenic
plants. And I think regardless of the trait it would be regulated. I\'m
trying to see where \--

MS. SULTON: Where this becomes an issue.

DR. SCHECHTMAN: \-- where this is \--

DR. DYKES: If you\'re saying triticale, in my day triticale was my novel
product.

DR. SCHECHTMAN: But, I mean, any plant that\'s genetically engineered,
there\'s a system \--

DR. LAYTON: To take care of it.

DR. SCHECHTMAN: \-- for doing it.

DR. LAYTON: Is any animal where there\'s genetic engineering, is there a
system to take care of it?

DR. SLUTSKY: If I could just make a point that animals, you know, I
understand why we\'re including animals in some issues, but, just keep
in mind that down the road \--

DR. LAYTON: We\'re going to deal with animals.

DR. SLUTSKY: \-- we\'re going to deal with animals in a lot more detail.
But, just to \--

DR. LAYTON: You\'re right.

MS. SULTON: Russell and then Greg.

MR. KREMER: These novel animals, so to speak, we\'re talking about novel
animals, I mean, although they may be a novel animal they can be an
agricultural occupation.

DR. SCHECHTMAN: There\'s a whole separate issue on transgenic animals
that\'s in here and underneath for understanding regulatory issues and
there will be a new project on transgenic animals a little bit down the
road.

DR. LAYTON: Let me suggest something. Have we \-- and I know this is
outrageous, but, have we covered this enough that we could potentially
not have this issue?

UNIDENTIFIED MALE: Yeah.

DR. LAYTON: Okay. We don\'t have everyone here, but, can I propose that
it was, and I need to see a firm, propose that it be excluded? And I
will do this in the documentation. So, I only got one, two, three. All
right. Here\'s the question. Can I propose to exclude this topic in the
future in our next document?

In other words, I\'m going to put a \--

UNIDENTIFIED MALES: Delete it.

DR. LAYTON: Delete this issue. Propose to delete this issue. Thumbs up?
Duane is not thumbing up. Can\'t do it.

DR. SCHECHTMAN: Yeah. Who wants it to stay in?

DR. LAYTON: Who wants it to stay in?

DR. SCHECHTMAN: Okay.

DR. LAYTON: Okay. I\'ve got three people \-- four people. Three people
want it to stay in. Lisa has another question.

MS. ZANNONI: I have another point that Greg was going to comment on.

DR. JAFFE: I mean, I was going to say, I mean, I don\'t think you can
define novel as it doesn\'t fall within the regulatory framework because
I mean, I think it may challenge the regulatory framework even though it
may fall within it. And, to me, this issue to some extent is, you know,
seven years ago we predicted the PMP\'s and the PMIP\'s, they fall
within the regulatory framework but there\'s been lots of issues that
the regulatory framework wasn\'t ready to address and how to adapt for
it.

And, so, to me, the issue is that this technology is constantly
changing. We will see novel things. I can think of something novel\--
would be a lot of, potentially, some of the crops that they're thinking
of being engineered that might have nutritional benefits. They will
raise novel issues by the regulatory system and FDA. How much is enough
to be considered to consider it a benefit that you can label it?

There may be issues of how do you assess the safety of those kind of
things? What happens if you knock out an allergen but there\'s still
some percentage of the population that may have some allergenic
properties to it? I mean, there may be some safety issues that are
raised by something that we are calling more novel than just a BT or
resistant new types of crops.

They still may fall within the regulatory system. I look at this issue
as again trying to \-- would we have seven years ago thought about
PMP\'s or PMIP\'s and been able to have told the agency they needed to
sort of think about this more? I don\'t think we would have. But, I
think this issue raises those kind of things that the agency needs to
keep thinking about the fact that there will be novel things that may
challenge some of these definitions and boundaries.

MS. SULTON: So it\'s almost an advisory to be diligent.

MS. ZANNONI: I would suggest that they stay in; that we actually have a
different term than novel because novel\'s in the Canadian system and
it\'s in the EU system which the U.S. system, I don\'t think somebody
should think that\'s what Canadians think and should have to accommodate
those types of things or the EU, so, I think we need a different word.

DR. SCHECHTMAN: Whatever they think is novel we\'re going to be
challenged by.

MS. ZANNONI: Exactly.

DR. DYKES: And novel depends on who it\'s \-- like novel to the EU.

MS. ZANNONI: It\'s defined in both the EU and it\'s defined in \--

DR. DYKES: If it\'s something the Europeans \-- a kiwi was introduced to
Europe, so it\'s novel to them but it may not be novel to somebody else.

DR. VAN EENENNAAM: Let\'s get it right. I think Duane said, you know,
it\'s going to be new all the time. That\'s not \-- it\'s \-- it\'s \--
it\'s unanticipated. I don\'t know.

DR. LAYTON: I\'ll do a thesaurus check.

MS. SULTON: Okay. Bob?

DR. HERDT: Well, I just wanted to support Greg. I mean, this is a
general statement. The regulatory agencies have to be in a new mode of
thinking that new things are going to come along that they\'re going to
have to address and be able to deal with things that raise new
challenges. I mean, that\'s what this is saying. So, I think we should
keep it in.

DR. LAYTON: Can I utilize the concept that he used before as an example
which were PMP\'s and PMIP\'s seven years ago, would they be in this
class and, therefore, you know, given that we\'ve seen this development
once we should at least anticipate something\'s going to happen like,
not like that exactly, but, something will happen in the future and
it\'s just \-- it\'s almost a precautionary principle.

MS. SULTON: Okay. Do we have enough on this to rewrite it, everybody?

DR. LAYTON: We got at least a try.

MS. SULTON: Or do you have something burning?

MR. GRANT: Well, actually I don\'t have anything burning and I have to
leave, but, I would say that I think to suggest that there would be
novel products would clearly follow within in the existing framework for
which some new type of regulation needs to be developed by the Secretary
or by USDA or, etc. I think we said that in several other issues and,
so, this one to me is worth keeping only if it focuses on developments
on products that are technologies that are clearly outside of the
existing Coordinated Framework.

Otherwise, I think we\'ve covered it.

DR. DYKES: I\'d just like to ask a question. I guess I think there\'s
two things in there. And I think they\'re different than what you had
suggested and Greg suggested. PMP\'s seven years ago, I\'m fine with
that logic that there may be things coming. But, would they fall within
or outside the Coordinated Framework I think is a totally different
thing. So, now we are anticipating things for which we have not defined,
but, we\'re confident enough that they\'re going to be outside the
Coordinated Framework.

I don\'t know how we could be confident they\'re going to be outside the
Framework when we don\'t know what they are. I could foresee us saying
new things for which we\'ve not encountered, e.g., PMP\'s, PMIP\'s from
seven years ago, but, the question of how they are regulated and do they
fit within the system or something like that to ask, but, just to
presuppose they\'re going to be outside when we can\'t say what they are
I have a problem.

MS. SULTON: Lisa?

MS. ZANNONI: I think it would be hard to come up outside the Coordinated
Framework because Coordinated Framework is probably vague so that means
you have a different kind of product at the end. I mean, within \--
it\'s really within the agencies when they have a different mode of
making the product. Isn\'t that what it is? It\'s not falling out of the
Coordinated Framework.

DR. DYKES: Right.

MS. ZANNONI: The technologies aren\'t in the Framework.

DR. DYKES: But, that\'s what we just said here is we want to anticipate
things that will be outside the Framework.

MS. ZANNONI: I know, but, that means you have a whole different kind of
product.

DR. DYKES: I don\'t agree with that I\'m saying.

MS. SULTON: Okay. We\'ve got that. Michael?

DR. SCHECHTMAN: Yeah, two points. I mean, I think it\'s possible that,
you know, there may be some things for which there are some questions
about exactly how they fit within the Coordinated Framework. There\'s
that question. But, also I think the question of particular things not
having been anticipated using the example of PMP\'s and PMIP\'s, I think
those things were actually anticipa \-- you know, the idea of plants
producing pharmaceuticals was anticipated in APHIS\' regulations of
eight years ago.

Whether they still pose challenges, which they obviously have, is a
different matter, but, I don\'t think you want to necessarily say that
those things were completely unanticipated.

DR. JAFFE: I don\'t think the question does. It says these things may
challenge the abilities for an efficient and scientifically sound
regulatory system. So, I think \--

DR. SCHECHTMAN: No, I\'m not \-- the way you refer to these things as
being \--

DR. JAFFE: I meant that they weren\'t \-- that the system didn\'t
anticipate all of the issues around them.

DR. LAYTON: And how will these fit within the Coordinated Framework in
the future is what I heard Michael state.

DR. DYKES: I just want to \-- I agree it\'s helpful to this committee to
say, listen, keep thinking out there. There\'s some things that you may
not have thought about, and I agree and that\'s where Bob\'s coming
from. I totally agree with it. I just think to add as much to it as we
can is the thinking to be helpful so that it is something that you can
really get your hands around it rather than just kind of a
non-descriptive sentence and I don\'t, myself, know how to do it, or,
later on do we want to conclude that this is something, this is a
statement or a comment we make someplace else in the document as a
conclusion, part of a conclusion that says we\'ve talked about a bunch
of things, just be aware that in this whole area it\'s changing so
rapidly that there may be new things coming for which are unanticipated.

So, I\'d like to reserve whether I think this is worthy of a special
notation here without having some more specificity put around it.

MS. SULTON: All right. Ron?

MR. OLSON: I\'d probably change my vote to keep it. One thing that the
University of Minnesota says that we eventually will move some things
that are substantially equivalent to things that are substantially
different. And, so, the question is how do you define a grain that today
is substantially equivalent, when does it become substantially
different? I mean, that\'s the \-- to me, those are the kind of words
you\'d use in something \-- and that, I think, is the issue as where\'s
the boundary of what\'s substantially equivalent to substantially
different. When does it cross that boundary? I think that\'s the \-- and
how does the system make that evaluation.

And if it is, then what happens.

DR. DYKES: The specificity of it.

DR. SLUTSKY: I think you need to be careful using the term
substantially.

MR. OLSON: Yeah, but, that\'s the concept I think I\'d like to see first
spelled out under this and you don\'t need to use those words because
they\'re used in other terms.

DR. LAYTON: Can you think about that on your way home and maybe send me
an e-mail? That would be helpful.

MR. OLSON: I was going to sleep on that.

(Discussion off the record)

MS. SULTON: Okay. It\'s a quarter to four. Should we try one more, the
transparency issue?

(Discussion off the record)

MS. SULTON: Okay. This is kind of a big one. We have a lot of comments
on it. It\'s the transparency issue which means transparency in the
regulatory system is important for enabling stakeholders and the
consuming public in the U.S. and elsewhere to have competence in the
safety of genetically engineered agricultural products.

And we have suggested rewrites from Daryl, as well as \--

DR. LAYTON: Greg, Mardi. Well, Alison has rewrites. Daryl has rewrites.
Greg has some understanding issues. And Mardi had some edits.

MS. SULTON: And actually it looks like she provided us a rewrite as
well.

DR. LAYTON: She did, yes.

MS. SULTON: It\'s called a products statement \-- I mean of the topic
statement.

(Discussion off the record)

MS. SULTON: The question becomes about the topic statement. Looking at
the original and the suggested changes and your own ideas. Greg?

DR. JAFFE: I have a one word suggestion which is to change products to
organisms. Especially when you\'re talking about transparencies here.
You\'re talking about transparency of the crops and animals and the
regulatory system, or, are we talking about transparency in terms of
labeling of the food, finished food products, and I don\'t think we\'re
talking about the latter. I think we\'re talking about the former.

And by putting genetically engineered agricultural products that leaves
that ambiguous.

DR. LAYTON: So, genetically engineered agricultural organisms and
you\'re fine.

DR. JAFFE: Delete agricultural.

MS. SULTON: Okay. And that would be consistent with the way it was said
earlier.

DR. LAYTON: Mardi wanted to take out enabling stakeholders. It\'s
essential if stakeholders, customers, and consumers in the U.S. and
elsewhere are to have confidence in the safety of genetically engineered
organisms. Any preference?

DR. DYKES: I like the way it is but I don\'t know if it\'s a major part.

DR. LAYTON: It just makes a better read.

DR. HERDT: Well, I think the big thing she has done is to use the word
essential.

DR. LAYTON: Instead of important.

DR. HERDT: Instead of important. And then use the word essential if
stakeholders are to have confidence rather than enabling stakeholders to
have confidence. I think getting that enabling out is an improvement.

MS. SULTON: Everybody okay with going to Mardi\'s rewrite on this?

DR. SCHECHTMAN: Can I ask \--

MS. SULTON: Michael?

DR. SCHECHTMAN: Yeah, I just wanted to ask a question about it. I just
wanted to get folks\' views. If then, you know, I know there are
examples about systems that are then prevented by law in the
descriptions, various versions of descriptions, but, providing
information at certain times. Do you want that sentence to say that
it\'s essential for there to be confidence and have the examples
implying that there is, therefore, no confidence. Maybe some believe
that, but, I don\'t know that everyone around the table believes that.

DR. DYKES: Yeah, I guess that\'s partly where I\'m coming from on that
issue. And the other thing is I\'m thinking about the EU system as a
matter of fact when I think about the transparency and I don\'t want to
sit here and say that, in fact, the EU system is not transparent,
therefore, the EU consumers don\'t have confidence. I don\'t want to
presuppose that because I don\'t know that we\'re going to necessarily
improve the transparency EU regulatory system.

I think it\'s important that I agree that more transparency is better. I
don\'t know the right equation, if not transparent than no confidence. I
think there is some confidence in the EU system today, but, it\'s
certainly not very transparent.

MS. SULTON: Well, if you want to just then just get rid of the word
enabling, you could say what Bob had said earlier that transparency in
the regulatory system is important for stakeholders and the confidence
of the consuming public.

DR. SCHECHTMAN: For stakeholders to have confidence.

DR. HERDT: Yeah, that works.

MS. SULTON: Bob?

DR. HERDT: Yeah, that works.

MS. SULTON: Is important for stakeholders to have confidence in the
safety of genetically engineered organisms. And the U.S. and elsewhere
staying in.

DR. VAN EENENNAAM: Do we want to cover the whole national and
international?

MS. SULTON: Do you want to keep in the U.S. and elsewhere or are you
going to suggest \-- are you suggesting that we take that out?

DR. VAN EENENNAAM: I don\'t know. I know we went through all this last
time and I don\'t remember the discussion to know for sure if someone\'s
adamant about that being removed.

DR. JAFFE: I mean, I think historically that comes back to somebody
who\'s not on the committee anymore, was Keith Triebwasser who had
always talked about the concept that the lack of transparency in the
U.S. system hurts him when he gets his products and tries to explain
them abroad and, so, I think that\'s part of the reason behind this was
the concept that the information access here will help understanding of
the products and not just here but elsewhere.

DR. VAN EENENNAAM: That\'s what the discussion was.

DR. DYKES: Well, this morning you changed U.S. and elsewhere to around
the world. So, I like that. I think we\'re talking about generally
speaking \-- generically speaking more transparency is better for
increasing confidence in the consuming public, whether it be here or be
anyplace.

DR. LAYTON: Stakeholders or consumers?

MS. SULTON: Well, they\'re both up there. Stakeholders and consumers.

DR. LAYTON: Okay. Are stakeholders customers? We\'ve not used the term
stakeholders before. That\'s why I\'m trying to \-- we did? Yesterday?
No?

MS. SULTON: We had one or two times.

DR. LAYTON: Never mind. I withdraw my comment.

MS. SULTON: Okay. Ron?

DR. JAFFE: I think you want to say in the U.S. and \--

MS. SULTON: In the United States and \--

DR. JAFFE: I mean, that\'s the \--

MR. OLSON: I just have a question.

DR. JAFFE: Say around the world and elsewhere in the world, or,
whatever. Right what we said before.

DR. DYKES: Around the world is what we said before.

MR. OLSON: I just have a question. I mean, if somebody knew that
FlavrSavr^®^ tomato had a fish gene in the plant would that inspire
confidence or inspire less confidence if you were more transparent about
some things? I don\'t know that we can always assume that transparency
means more confidence. It might destroy confidence.

I mean, if you instruct people who know nothing about biotech, you talk
about FlavrSavr^®^ tomato and you can say well, there\'s a mackerel gene
in there, it makes them feel worse than if you just tell them \--

DR. SCHECHTMAN: That there\'s what in there?

MR. OLSON: A fish gene or something like that. But, I mean, that\'s the
concept. If it\'s an animal gene that\'s crossed into a plant does that
make them even less confident?

DR. HERDT: If something is there it\'s going to come out. It\'s going to
come out in the public. I mean, so, therefore, transparency in the \--
from the official system is better than if it\'s then not because that
information is going to come out. They didn\'t say so, they said it was
okay, but, there\'s a mackerel gene in there. Don\'t go there.
Transparency is better. That\'s what Bob said.

DR. SLUTSKY: So, what you\'re saying is transparency \-- I\'m sorry. It
doesn\'t necessarily \-- I mean, he\'s not saying not to be transparent,
but, \--

MR. OLSON: I agree with Bob to tell the truth, but, some customers may
be more uncomfortable when they know what happened. So, I don\'t know if
linking confidence \-- I mean, obviously any information is better than
none, so, transparency typically is good, but, it may not to lead to
more confidence or confidence. It may lead to less confidence.

MS. SULTON: I guess the issue could be whether you\'re consistently
transparent.

MR. OLSON: Or maybe it\'s just something to think about the rest of the
time.

DR. LAYTON: I know that some of my folks don\'t want to have their crop
rotations or test locations known out in the public world because of
organizations like the Earth Liberation.

MR. OLSON: That\'s another side of it, yeah.

DR. LAYTON: And \--

DR. DYKES: Well, I think what you\'re going to is limitations around
just how far you go with transparency. That\'s one. And the other one\'s
Confidential Business Information on what gene contracts are. So, I
mean, most of the time this issue comes up because it\'s directed at the
U.S. system. I would contend the U.S. system is far more transparent
than a lot of the others. So, I\'m usually fine with it because I
generally believe, as Bob was saying, if it\'s there people are going to
find out so it\'s much better just to tell them.

You do have to have some limitation. You just can\'t turn over all the
raw data, you can\'t just turn over all the CBI stuff, all those kinds
of things. But, I don\'t think when I read this I\'m not thinking this
is going to dramatically change the U.S. system. I\'m thinking that
there are a lot of other systems that are a lot less transparent than
the U.S.

MS. SULTON: Okay. Russell?

MR. KREMER: I appreciate what Michael\'s saying. I think we have the
obligation, we\'re serving the stakeholders and there are a lot of
people involved in that and I would be truthful. It\'s a transparent
system.

DR. LAYTON: Okay. So we\'ll work on it.

MS. SULTON: Greg and then Ron.

DR. JAFFE: I was going to say I agree with Michael that we have one of
the more transparent systems in the world. I have a lot of criticisms
about the transparency of the system and this is a very important issue
to me in this report that our system needs to get better as transparency
and I think that relates to the future of agricultural biotechnology and
debate about it.

Whether there\'s confidence in genetic engineering organisms I don\'t
have a strong view one way or the other about that. In terms of the
contents of the write-up here I think there are a fair number of factual
inaccuracies in it. Being a lawyer there are certain things in it that I
don\'t think \-- that aren\'t either covered by the law or not properly
described in terms of what is exempt and what isn\'t exempt. These need
to be worked through and I think I wrote some comments about some of
those.

MS. SULTON: Yes.

DR. JAFFE: I also think that one of the examples is incorrect because
they actually expose the letter they send back to the company on the
voluntary disclosure so I think that that\'s not a good example to use.
Second of all, I think we have to have a USDA example and have a USDA
example that\'s critical of USDA\'s lack of disclosure, lacks of
disclosure that are not necessarily legally \-- this is not an issue.

The problem with the write-up in my mind is the issue here isn\'t \-- is
there are two parts. One is the lack of transparency where one is not
allowed by allowed to, but, there\'s also lack of transparency where, as
far as I know of, there is no law preventing that, but, it\'s agency
policy or prerogative or \--

DR. SCHECHTMAN: Inefficiency.

DR. JAFFE: \-- inefficiency or what, I don\'t know what the reason is,
but, I feel it\'s important to have an example in that situation and
USDA \-- I can come up with USDA one and provide that to you.

MS. SULTON: Wait.

DR. JAFFE: But, this is a report of USDA and use two FDA examples is not
appropriate I don\'t think.

MS. SULTON: So, Greg, if you could expand upon your comments here and
provide that to Pat that would be helpful. We are approaching four
o\'clock and Ron has to go.

MR. OLSON: Just a thirty second one. Just to follow up on what Greg
said. I think part of that presentation and keeping that one together is
it\'s how do you get to the safe harbor concept and it was transparency,
getting a positive statement rather than make the letter public. Somehow
if there\'s a positive statement. And then also the education side of it
is that there\'s a lot of people just don\'t understand.

I don\'t know if that ties into this one. It might be a separate issue
again but, I think those were all kind of looped together when that
presentation was made about a year and a half ago.

DR. SCHECHTMAN: Wasn\'t that positive statement really relating to the
other FDA issue about the safety, of the new system of FDA. Is that what
you\'re talking about?

MR. OLSON: I was just saying it would be nice if you\'re going to
release some food product with some trait that\'s there that somebody
would stand up and say yes, we have looked at this and it\'s safe. That
kind of stuff. And you can\'t. So, I mean, that was the concept of the
discussion about transparency would cover more, focused on making sure
people understand that there is a regulatory system that looks at this
stuff that is known to the public. It\'s the education side of what\'s
done as much as what is said. It\'s part of the discussion as well.

MS. SULTON: All right. I\'m going to wrap up topic 16 and turn to Pat.

DR. LAYTON: Okay. We have a very ambitious set of work to do and I see
that our next issue is the AC21 members differ in their views. So, I
would encourage you to tell me if I\'ve done that one wrong or what I
need to do on that one so I just want in response please tell Carol to
send it to me also. That is our next one to do.

I will, along with staff, work very hard to get this out. I think it\'s
important to move forward. Believe it or not, while it feels like we
didn\'t do a lot, man, we\'ve done an awful lot. I really \-- you know
\-- we\'re a lot farther along and when you talk about issues, you know
we weren\'t starting all over again. That was good news.

I mean, process-wise there\'s a lot to be congratulated. We\'re moving
along and I think we have a process that will get us to a point that we
will get this report out, I think, successfully. And I think that\'s to
be congratulated on \-- ourselves on and I think it will then allow us
to focus shortly after January on the next set of work that we have to
do.

I would ask that is there any way possible that for those of us who are
flying in next January, because we do need that Friday to be a good work
day, and I do understand that I, too, would love to get home early on
Friday night, if we could possibly do an earlier than 8:30 start on a
Friday morning for those of you who live in town and for those of us who
are local.

I may ask that in my letter is that, you know, \--

DR. SCHECHTMAN: To give us a little more time?

DR. LAYTON: Yeah, to really work 8:00 to 3:30 or 8:00 to 3:00, you know,
really work and focus hard on an 8:00 start, not an 8:30 start because
we really want to get it done. Thursday, I can wait on Thursday, maybe
go an extra hour, maybe go 8:30 to 6:00 on Thursday, whatever. If we can
keep our schedules flexible then. We have a lot of work to accomplish at
that point in time and if we can avoid making evening commitments that
Thursday evening, early evening commitment, and is there a religious
holiday?

DR. JAFFE: I don\'t think so.

DR. LAYTON: I hope not. Okay. Could you stay till 6:00 if we had to?
I\'m going to put that in my letter to you, on that Thursday, and at
least and start at 8:00 because this is an important meeting. We can go
back to a more flexible schedule, but, I want to get as much work as we
can, start at 8:00 Thursday and Friday?

DR. JAFFE: Yes.

DR. LAYTON: I know that it\'s hard because you guys have meetings like
this all the time, but, it would be nice if we could do it just for that
one meeting and then go from there.

(Discussion off the record)

DR. LAYTON: Okay. That was my concern and with that I, again, thank
everybody for their real hard work on this one and let\'s be respectful
on our dates and getting our comments in.

DR. DYKES: One of the things about the process this time that I would
add, we can talk about these things in work groups and that\'s okay,
but, we don\'t make the progress on them unless we got them back here in
the full committee discussion so I agree with you, Pat. The best way you
make progress, taking these difficult things off the work groups and
then bringing them back in and half the group still doesn\'t agree with
them, I don\'t know if you really accomplish much.

And that\'s what happened on all the old issues. They\'ve been in work
groups fifteen times and then rewritten fifteen times.

DR. SCHECHTMAN: But, to be fair, we\'re not in work group. These were
Pat and my people\'s attempt to shrink what were difficult and
non-consensus.

DR. LAYTON: Some of them were in work groups though. There were a couple
of that had been.

DR. DYKES: And I am complimenting you on the process.

DR. LAYTON: Thank you.

DR. DYKES: I\'m just saying that this is slow but to take these
difficult issues and put them off on work groups and then come back here
and we\'re just kidding ourselves if we think we\'re making progress.
That\'s why we made real progress today. We did it in the full
committee.

DR. LAYTON: I think it also helps to have other people\'s comments
written out so we can compare notes and I really do think that helps.

DR. SCHECHTMAN: Okay. Are we \--

MS. SULTON: I am going to adjourn unless Michael has some other
comments?

DR. SCHECHTMAN: No, I would just echo my words of thanks. I think you
all did a whole lot of hard work and we\'ll keep that pace up until the
next meeting.

DR. LAYTON: Okay. Happy Thanksgiving and Merry Christmas.

(Whereupon, at 4:07 p.m., the meeting was concluded.)