UNITED STATES DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C.

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:

ADVISORY COMMITTEE ON :

BIOTECHNOLOGY AND 21ST CENTURY :

AGRICULTURE (AC21) :

ELEVENTH PLENARY MEETING :

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A meeting in the above-entitled matter was held on Thursday, January 5,
2006, commencing at 8:30 a.m., at USDA, 1400 Independence Avenue, S.W.,
Room 107-A, Jamie Whitten Building, Washington, D.C. 20250.

Dr. Patricia Layton, Chairperson

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

Patricia Layton, Chairperson

Michael Schechtman, USDA

Abby Dilley, Resolve

Kathy Grant, Resolve

Cindy Sulton, HW&W

Bernice Slutsky

Leon Corzine

Duane Grant

Kathleen Jones

Randal Giroux

Josephine Hunt

Elizabeth Milewski

Carole Cramer

Russell Kremer

Gregory Jaffe

Jerome Slocum

Michael Dykes

Vincent Vilker

Ronald Olson

Margaret Mellon

Carol Tucker Foreman

Bradley Shurdut

Alison Van Eenennaam

Lisa Zannoni

William Hensley, Public Commentor

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

DR. LAYTON: And just an update. Daryl is not going to be with us today
and neither is Bob Herdt, although we\'re expecting I think everyone
else.

DR. SCHECHTMAN: Yes.

DR. LAYTON: So, that\'s just an update of who\'s missing and who\'s not
coming.

DR. SCHECHTMAN: Okay. I guess we\'ll officially get started then.
Welcome everyone. Happy New Year and good morning. This is the 11th
meeting of the U.S. Department of Agriculture\'s Advisory Committee on
Biotechnology and 21st Century Agriculture for AC21. I\'d like to
welcome our committee members today. I\'d also like to specifically
welcome an addition, Dr. Kathleen Jones, who will be our new *ex
officio* member on this committee from the U.S. Food and Drug
Administration.

She replaces, if anyone can replace, Dr. Jim Maryanski, who has retired.
We wish him well and welcome to our discussions, Kathleen. To my left is
the AC21 Chairman, Dr. Patricia Layton, from Clemson University. To my
left and right a bit further out are our facilitators, Ms. Abby Dilley
and Ms. Kathy Grant from the organization, Resolve, and Ms. Cynthia
Sulton from the organization, HW&W, who are our partners in helping us
make the advisory committee process work.

Also joining us, probably in a few minutes, is USDA\'s senior advisor to
the Secretary for Biotechnology, Dr. Bernice Slutsky, who will be
helping us out as well. We\'ll have a very full agenda so we ask that
when the meeting is in session conversations need to be limited to those
between members. The public will be invited to participate by providing
comments to the committee and USDA this afternoon between 3:30 and 5:00.

For any members of the public who request to speak during the public
comment period, I will need hard or electronic copies of your remarks.
We will be preparing the Minutes of this meeting and a computer
transcript of the meeting will also be available within a few weeks. We
hope to get the Minutes and all meeting announcements up on the Web. I
should let you know that the USDA has a new website. The AC21, rather,
has a new website and a new web address that\'s linked to the overall
USDA website.

The committee\'s new web address is www.usda.gov/ac21Main.xml. I\'ll
check to make sure that these are correct up on the board at the break.
The committee can now also be reached through USDA\'s new main biotech
portal and I\'ll put that address up during the break on the wall \-- on
the board. This has all been done to make the committee\'s website match
the overall format, look, and feel for USDA\'s other web-based
materials.

It\'s still a work in progress so there may be a few glitches along the
way in the transition from the old web address to the new one. In
theory, all the content has been transferred and you\'ll automatically
be rerouted if you use the old address but I\'ll need committee members
to let me know if you encounter any problems.

Now, for any members of the press who may be here you\'re welcome to
speak to whomever you wish during the breaks of our meeting and before
or after the meeting itself. We ask that you not conduct any interviews
or request comments from members while the AC21 is actually in session.

Dr. Layton, our Chair, and I will be available for questions and
comments at the end of each day\'s meeting. I\'d like to request that
all members of the AC21 as well as all members of the audience and the
press who are going to be here please shut off your cell phones and
beepers while in the meeting room. Bathrooms are located on either side
of the main patio outside; ladies on the near side, gents on the far
side.

Just outside the room there\'s a table with meeting documents and
background documents on them. Please take only one copy of each. For the
information of members of the public let me indicate that AC21 has two
distinct charges from the Secretary of Agriculture in its charter.
First, examining the long-term impacts of biotechnology on agriculture
and the work of USDA, which the AC21 has interpreted to mean five to ten
years, and, secondly, addressing specific biotechnology-related issues
identified by the Secretary.

Now, the committee has completed one paper each related to those two
charges and is currently working on completing another paper which deals
in a broad way with that first charge as well. We also anticipate that
the committee will take on some additional work relating to the second
charge in the near future.

As for meeting documents for this meeting, there are several background
documents and they are, first, the official AC21 Charter, then the AC21
Bylaws and Operating Procedures, then a package of biographical sketches
of all of the current AC21 members, a draft Meeting Summary prepared
from the 10th AC21 meeting which was held on October 24th and 25th of
last year, and, finally, a package of six meeting summaries from
open-ended work groups that met between the last plenary in August or,
rather, between the last plenary in October and this meeting, to work on
the introduction and the various topics that followed.

Now, specific for this meeting we have a few official documents as well
as a couple of small glitches that I will indicate. First we have the
provisional agenda for this meeting. This is actually one of the
glitches. There\'s a slightly different version of the agenda from the
one that you received previously. Basically what\'s happened in the
agenda is that discussion of the topics has been moved before a
discussion of the introduction. I had thought that this version was sent
out previously. We just noted this last night, but, essentially it\'s
just a switch of a few topics.

Secondly, the next document, which is our main working document, is the
current version of the draft text of the current paper, both
introduction and the topics of discussion that follow side-by-side with
all the comments compiled from members. I\'ll have more to say about
that document as we progress this morning.

I should indicate, however, that at each of your places there is another
version of topic number 23. We discovered again last night that the
version that was sent out to you was incomplete. So there is a new
version of number 23 which contains, I think, an expanded view of the
views of one camp on the discussion.

There\'s also another document with the header, working draft with
possible approaches to incorporating comments, which committee members
received just this week. It contains possible language incorporating
many of your collective comments on the December 22nd document. Now,
that document is not intended to be the text from which the committee
will work. It\'s not a substitute for the draft that Pat sent out on
December 22nd.

Instead, it\'s offered as a means of facilitating the editing process as
well as your deliberations to help find language for some challenging
sections. The plan is that the committee will work from the draft report
that was sent out by Pat. However, if it becomes desirable and
appropriate to bring in the proposed language in that new document that
can be an option of the committee if it so chooses.

And, finally, the last document for this meeting is a one-page listing
of the topics for future work of the committee which was discussed two
meetings ago and which has one very minor change in it reflecting the
discussions we had at that meeting. We\'ll talk about this actually only
very briefly at the end of our two day session.

I\'d like to take a moment as an aside to thank all of the committee
members for their willingness to adjust their schedules around the
holidays and for their hard work in participating in calls and in some
instances drafting new text, either singly or in groups, to produce the
current text we have and also for reviewing text and providing comments.

Please note on the agenda for this meeting that there are breaks
scheduled this morning and afternoon. For members of the public who wish
coffee, coffee is available below us one floor in the cafeteria. Also,
on the agenda, let me note again that we\'re planning for a period of
one and a half hours for public comment from 3:30 to 5:00 p.m. today. We
want to be responsive to the needs of the public and we\'ll see as the
meeting progresses how we need to structure that time.

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

We have a few brief updates for the committee. As all the AC21 members
should be aware, on October 13th of last year a Federal Register notice
was published announcing an open nomination period for membership on the
AC21. That nomination period ended 30 days later in November and we
received around 35 nominations for membership on the committee. No
choices have yet been made for positions on the committee.

Now, the current terms of membership for roughly half the committee
members expire in February of 2006 and additionally we have lost Dick
Crowder from the committee. He has left the American Seed Trade
Association to become the chief agricultural negotiator for the Office
of the U.S. Trade Representative. He was confirmed by the Senate a
couple of weeks ago. Ambassador Crowder will be missed in our
discussions and we wish him well.

I should also note that in expectation of moving on to new committee
topics and specifically in expectation of moving on to work related to
specialty crops soon and transgenic animals in another year or so we\'re
considering how best to have the flexibility to address new and
different work topics.

You should all expect that there could be greater turnover on the
committee from this appointment cycle to the next in order to bring in
specific new expertise onto the committee. Needed flexibility might also
be provided by amending the charter to expand the committee is likely,
using sub-committees possibly, or, maybe some other approaches. We\'re
still in discussion with the Secretary\'s Office and the counsel on how
best to structure the committee to take on the new work.

In view of the fact that we\'re planning to embark on the coexistence
topic soon we\'re also looking into having someone from the National
Association of State Departments of Agriculture or NASDA possibly join
the committee as an *ex officio* member, such crops being of
considerable interest in some states.

Now, from USDA\'s perspective, the main objective for this meeting is to
complete major work on a paper examining the impacts of agricultural
biotechnology on American agriculture and USDA over the next five to ten
years and to do this through review and revision of the current draft
text.

Secondarily to this meeting, again, we hope to have a very brief
discussion at the end relating to organization of the committee\'s
subsequent work once that first paper is completed. Everyone should
recall that the Secretary, when he met with some members of this
committee in May and received the two reports the committee completed
early in 2005, indicated his interest that the report under discussion
now be completed by around the end of 2005.

We\'ve stretched that date to accommodate the realities of the Christmas
season and so we\'ve brought you together so soon after New Year\'s. The
Secretary\'s office continues to be very interested in the outcome of
this committee\'s discussions on the whole range of topics you\'ve been
addressing since the AC21\'s inception and that are encapsulated in the
draft that you\'ve been working on.

The desire of the Secretary\'s office is that the work on this report
substantially be completed by the end of this meeting subsequent to
final editing and sign off as was done on the two previous reports. It
will be a benefit to USDA to be able to view this document in parallel
with the previously submitted and compare it to the future report as the
collective completion of those efforts.

It\'s unlikely that plenary work on the paper can be extended past this
meeting barring a clear indication of success would be imminent with
just a modest amount of additional discussion. It\'s particularly
important that the utmost efforts be made to achieve this goal at this
time because with the expiration of the current membership terms of half
the committee in February, the next meeting may see membership changes
and new members.

Whatever new insights and perspectives new members may bring, they also
complicate the process of finalizing any committee work. So there\'s a
great challenge ahead of you for the next two days. Many people on this
committee have invested a great deal of time and effort on this paper.
I\'ll have more to say about the actual text that you have and the
status of various portions of it a little bit later on.

I think, though, that the committee is pretty close to completing this
paper, maybe closer than many people realize, and I hope that just with
this next push we\'ll be able to get there. Now for a few exhortations
before the work starts. Firstly, each of you, I think, is anxious to
reach a successful conclusion on these efforts and the report is
important to each of you. So, I think it\'s important that everyone
needs to be willing to work, not only work a little bit \-- to work hard
a little bit longer, to persuade others of your points of view, but,
also be willing yourself to compromise on issues both large and small
for each of you.

A final report is unlikely to describe the world as you see it or
describe discussions in the words you prefer. As I indicated in the last
meeting, members cannot expect others to compromise in some areas
without themselves offering a similar willingness elsewhere in the
paper. Let me emphasize, as I did at the last plenary session, that from
USDA\'s perspective what is most useful in the final document is one
that reflects as much as possible with the things you agree on.

Members were selected to this committee based not only on their
expertise, but, also on the views they hold and the constituencies they
represent. Senior officials at USDA know it can be roughly the views of
individual constituencies on the various different topics. What an
advisory committee rather than a group of individuals can particularly
and uniquely add to USDA\'s understanding of a complex world is a
picture of where consensus exists.

So, I think that while some topics in the paper may need to be discussed
in terms of some people think A and some people think B, that\'s not
generally the most useful presentation. That having been said, I think
it\'s clear to all members that some topics in the paper will only
achieve consensus around a formulation of the some think A and some
think B format; that the AC21 will undoubtedly need to use that approach
in some instances; and that the number of topics described under that
format may expand a bit.

To my mind, it\'s an approach that does not add much new to the
discussion and that doesn\'t particularly build trust among committee
members and further the relationships that are critical to the
committee\'s continued success. So, that format needs to be used with
care and only when it\'s really necessary. On the other hand, the
quicker the committee realizes that that needs to be done on a
particular topic and can move on, the more efficiently our time will be
used.

So, we\'ll need to see in these discussions how often that format needs
to be adopted if there are places beyond where it currently is. We\'ve
set aside some time on the agenda should we need to break into work
groups on particular issues to resolve impasses or draft new text to
bring back to the full committee.

One final point I\'d like to make before I turn it over to the Chair,
let me suggest that each of you do your best to hold back from
interjecting editorial suggestions solely for the purpose of making the
report read better. Once again, you have a report that\'s been drafted
by committee. It\'s been smoothed out somewhat by the efforts of Dr.
Layton and myself but it\'s not a work of polished prose. I know we have
lots of great editors here, but, I think you have better and more
important tasks to accomplish at this meeting and your time is limited
and other work is going to await you.

Everyone would love to be an editor, but, my request to everyone is that
each try to exercise restraint in this regard. I\'ll have a little bit
more to say about the draft text in front of you in a little while, but,
first let me turn to our Chair, Dr. Layton, with your words of welcome
and views on the work that you and the committee members have done and
your thoughts for the meeting. Pat.

DR. LAYTON: Thank you. First let me welcome Kathleen. Thank you for
being here with us. I think most members have come in since Michael got
started, so welcome, everyone. I see we\'re still missing Mardi and
hopefully she\'ll be here soon and Josephine who we know is coming in a
little bit later.

Thank you again for being here today. In the world of academics where I
live everybody\'s still on vacation because classes don\'t start until
next week so for me this is like taking a holiday. But, I enjoy being in
D.C. and I enjoy being with each of you and that\'s what made a pleasure
to work with you all here and I\'m going to say that I know that we are
all great people and it\'s going to be a tough two days and I know it\'s
going to be hard to get through this, but, I want to congratulate every
one of us on getting this far.

I was on all but one conference call I think and a tremendous amount of
work occurred during this period in terms of getting words rewritten, of
making sure we were crisp and clear, and, in fact, you know, really when
you came down to it if you look at the topics that are listed, you know,
they all pretty much held up. It\'s the words underneath them that are
changed more than others. I think we did a great job on doing that.

During this period we added \-- we separated one topic into two and for
some of you who haven\'t paid attention that\'s one of the things that
happened. So, now we have 29 instead of 28. Even though there\'s only 28
numbers we have a 10-1/2.

But, it\'s been a tremendous, tremendous amount of work and several of
us had a drink last night and watched the beginning of the football game
and it was amazing, you know, several of the members commented how close
we are that, you know, while it looks like there\'s a lot of words here,
a lot of them are very editorial.

The substantive issues are very close and I challenge us to make sure we
deal with those substantive issues as quickly as possible so that we
really do get through this document. As we said, some members are
leaving and will not be returning. Ron, I think, is one that I know will
not be returning and I know he would love to see us finalize this
document as will others and move on to other things and I think we\'re
assuming that same position we were a year ago almost at this time when
we had members leaving and we wanted to finish up the document.

So, we have a challenge and we made it once. We\'ve done it on two
documents so I know we can do it this time and I\'m encouraging us all
to be sure to compromise when we need to compromise, to not be
editorial, but, to be substantive in nature in our comments, and to try
and work quickly through the document and get all of our thoughts on the
table as quickly and concisely as we can.

And it\'s that sort of conciseness and moving on to the spirit of the
document in getting those done. I\'ll just reiterate my welcome and say
thank you and I look forward to these two days of really, really hard
work and getting done with everything we need to get done. Michael.

DR. SCHECHTMAN: I think we are now ready to turn this over to the
facilitators for a little while. Let us know where we are and talk about
the summary.

MS. DILLEY: We have a question. Carol.

MS. TUCKER FOREMAN: It\'s not really a question. I\'m sorry to start off
on a dissenting note, but, I\'m going to. It seems to me that this
document is of value to the Secretary and to the Department as much for
what it says about where we\'re unable to agree as it is where we\'re
able to find consensus.

You only mentioned where we could find consensus. I think the fact that
we\'re not able to reach consensus in some areas is very instructive to
a Secretary who spends about 90 percent of his time speaking to
organizations that have an agricultural point of view and that knowing
that that is not always the majority position in the United States is of
value to the Secretary.

So, I\'m not going to be able to just sit back and say I give up on
this. Second, I\'m troubled about the notion that we should ignore
editorial work on this document. Using glittering generalities and
language that is unclear is not a service to the Secretary and, frankly,
it\'s not a service to us if people read it and think that we\'re not
able to write English very well.

The meaning, the substantive meaning of what we want, what we intend,
can be completely eliminated by language that\'s so diffuse and general
that nobody knows what it is we\'ve said. So, again, I\'m just not going
to be able to say that we should forego editorial comments because I
think the document that we have has come a long, long way, you know,
that Pat spent her holiday putting together the jigsaw puzzle, it is
really an amazing work of art. But, the document can\'t go forward, in
my view, unless it is something that most people can read and
understand.

MS. DILLEY: I would just like to respond, Carol, to those comments
because I don\'t think you\'re disagreeing with Michael. What Michael
said is where we want to emphasize our time. I mean, I think, first of
all, over the course that we\'ve been working on this document I think
the notion or the goal has been to try and find a unified way to express
a topic and an issue and there\'s also been recognition over time that
that\'s just where a topic gets onto the issue of where we share a
vision and we talk about that in the document then I think we can come
up with language that expresses a unified comment.

Where we don\'t, where there\'s just fundamental differences of where
people have fundamental differences on how that plays out in the future
or now, that we go to some members think this and some members think
that and I think Michael said that we recognize that up front. I think
still we don\'t \-- what we don\'t want to end up is 29 topics that say
some members think this and some members think that.

So, where I think where it\'s a goal to have unified statements I think
there\'s a clear recognition that we\'re not going to do that in every
single topic and the sooner we recognize that, as Michael said, then the
better off we are to be clear about what we are trying to say and what
different members \-- the different views that members have and to move
to that language.

I think right now we have about six topics, I think, the way I would
interpret Michael\'s comments is, hopefully it doesn\'t go from six to
29. It goes maybe six to eight, but, hopefully, the majority does not go
to 29. On the editorial comments, I think it\'s obviously 18 pages is a
lot to slog through in two days. I almost said ten days which is what it
would take. But, sorry, don\'t worry, you don\'t have to cancel your
plans for the next eight days.

So, the emphasis is really on trying to get the substantive points clear
and some of the editing can take care, hopefully, as follow up just as
we did with the last two documents. I don\'t think that means we skip
editing. Ideally we get to all 18 pages and we go through it. The one
document that you do have, that you received on the 3rd unfortunately,
but, it was mostly my attempt at trying to take all the comments,
including the editorial comments, and incorporating them into language
that I had offered.

And Alison did a particular amount of editing. Greg and Carol and Daryl,
who unfortunately is not here, but, trying to take those editorial
comments to make the document read better and take a run at it. So, I
don\'t think we want to \-- even though we\'re not working off that
document, but it\'s there to try and reflect the editorial comments that
hopefully make the document better, if members like that language,
great. If you don\'t, it\'s not fine, you know, and hopefully we\'ll get
to some of the editing.

But, I think where \-- in terms of setting priority I think we need to
focus on those \-- on trying to resolve some of the substantive issues
and the topics in terms of the gist of their meaning and then hopefully
do some editing work and some \-- because it does need to read. I mean,
it has to be an understandable document and I think a lot of effort has
really gone in to try and make it more understandable, but, that the
final edits will probably need to be done post this meeting because we
just \-- you know \-- we only have two days.

So, I mean, that\'s how I would translate and I don\'t think you\'re in
disagreement in terms of that.

MS. TUCKER FOREMAN: I appreciate the clarification.

DR. SCHECHTMAN: Yeah, and, in fact, I don\'t think that we\'re in
disagreement either. I mean, I think there\'s really a continuum of the
kind of edits that are offered and some are they think this word sounds
better, you know, or we can remove two words and make the sentence a
little bit shorter. That\'s one end of the spectrum. Those are sometimes
\-- you know \-- those may be a little bit less of a priority to address
here now than things where, as you pointed out, there are things that
are not clear.

Those things clearly have to be dealt with.

MS. TUCKER FOREMAN: Where are we going \-- where and when will we deal
with taking those words out and making the language clearer and more
concise if we don\'t do it now?

MS. DILLEY: Hopefully we will get to that as much as we can over the two
days and, again, I think we\'ve got \-- we have both the original
language and the document that we\'re working off of that\'s dated the
22nd. There\'s an attempt to take comments, editorial comments made by
various people and take a run at language reflecting those editorial
comments. If that\'s helpful, great. If it\'s not helpful, then we\'ll
get to as many of reworking those as we can and then we\'ll have to
figure out the plan to complete and send just as we did towards the end
of the last two documents, reports that were submitted, make a plan for
how do we edit and complete it and get it to the Secretary.

MS. TUCKER FOREMAN: I ask this because really on the labeling and
traceability report and on the scenarios report the material that \--
the changes that were made after the last meeting and before the
document was signed off on were really very, very minor. We sat in long
meetings and dealt with not just the substantive issues, but, most of
the editorial issues while we were here. And, you know, I think there
probably weren\'t more than 25 changes, sometimes very, very minor ones,
in that labeling and traceability document.

So, I\'d like for us to get to the point where we have a similar
experience here and in the event that we don\'t finish in the next two
days, you know, I came onto the committee a year after it had started
and with the scenarios and labeling and traceability reports really
already in a first, more than a first draft, and a little over a year
ago, December of 2005, 2004, I was willing to sign off on the labeling
and traceability report with asking very, very few changes, recognizing
that most of that work had been done before I joined the committee.

It is my assumption that if it\'s necessary in order for us to complete
our mission here that our new members would be willing to allow us a day
in session to finish this report if that becomes necessary. I\'m
perfectly willing to try to get through all of it and I\'ll shut up now
so we can start, but, I think it\'s important to recognize that it may
be necessary to do this. Thank you.

MS. DILLEY: And maybe we need to come back and revisit that at the end.
Let\'s see where we get over two days and then assess where we are and
what our plan needs to be to get it actually finalized.

DR. LAYTON: Let me just add, if I may, that, Carol, I think one of the
comments that I heard from some of the members during this last three
weeks or two weeks especially has been that you and Daryl both have
done, and also Alison because I know she caught all the grammar and the
commas, have done a remarkable job of editing and some felt in their
expressions to me that, you know, there are places where it's said
better in what you\'ve presented and I hope it\'s here so we can just
say "cut and paste this sentence into it" and go from there because
I\'ve heard lots of wonderful comments about the work that\'s been done.
And Greg also.

But, everybody did. But, I know particularly Daryl and Carol had spent a
lot of time and Greg also. So, that\'s where we are. One issue that I
will say I apologize for, I don\'t know if it\'s different Word versions
or what, some people\'s comments when you cut and paste come over with
the editorial stuff in and it still shows up. Some people\'s comments
when you cut and paste it loses the editorial comments. So, there is a
discrepancy.

But, I have with me a printed version of everyone\'s comments in color
that I printed before I left the office on Tuesday and I also have
everyone\'s comments on electronic document so if you do not have it or
if there\'s a question, for example, about Daryl\'s or someone else\'s
who\'s not here, I have everyone\'s comments as they came back to me.
And we can show them on the screen so that there will be no confusion
over what somebody meant or did not mean.

And, again, I don\'t know why it works that way and I am not a Microsoft
Word expert enough to fix it and sometimes it just is that way and
sometimes it isn\'t and, you know, I can\'t figure it. I didn\'t have
time to make it happen.

MS. TUCKER FOREMAN: If I were an expert on it you wouldn\'t have had the
problem with mine. But, I have brought, I think, ten copies of the
document that I sent around yesterday and I also have it on a thumb
drive.

DR. LAYTON: Okay. And the other issue, I will say, on your table, I hope
everyone got a copy, I have went through and cut and pasted everything
that is on the left-hand side of the text boxes that is the table
documents into a document with line numbers and everyone got a copy of
that this morning.

(Discussion off the record)

DR. LAYTON: And that is the version that is up on the screen to edit
from so I just wanted to let you know that nothing is hidden. I did
incorporate the last paragraph of topic 23 and I do not know how I
didn\'t pick it up. It was \-- it\'s three or four lines longer than the
rest of them and I don\'t know if I just didn\'t think it was below the
screen and I didn\'t see it, you know, when you\'re cutting and pasting
and it\'s hidden or what, but, I deeply apologize for that last
paragraph on topic 23. It has been incorporated here today.

So, I just wanted to let everyone know while we\'re working from the
side-by-side I did pull up on the screen a large version of it so it\'s
easier to see as we make edits. So, I just wanted to let you know I\'ve
done that too and that you have that so that we can all see.

MR. JAFFE: Pat?

DR. LAYTON: Yes.

MR. JAFFE: I just wanted to say I\'m going to pass out \-- I made copies
for the committee members of the comments that I had sent to Pat, both
the comments that you put into the compilation document, but, also, I
think I sent her a revised one of two days later that had comments with
the remainder of the issues that didn\'t get into the compilation that
was sent on the 22nd. And this is a red line strike out so everybody can
see the red line strike out version.

DR. LAYTON: Perhaps you\'ll just pass that around, Greg, so, everyone
will have it at the table. Thank you so much. That way we won\'t have to
pull that one up. It is hard, you know, if somebody \-- it is hard. It
helps if they all come at once because then you can\'t find what\'s new.
But, there was a deadline and we had to get it out.

MS. SULTON: Just one piece of housekeeping before Abby goes over the
agenda for the next two days and that has to do with the summary, the
Minutes for our meeting of October 24th and 25th. If you could kindly
take a look at that document and if there are any changes in the summary
just in the interest of time if you could provide those back to Michael
within one week that we can revise the Minutes and post it on the web if
that\'s agreeable with the committee.

We won\'t go over it now, but, I\'d ask you to get your comments in
within a week. Basically it\'s just a summary of the fact that we had a
meeting that focused on editing the document. Okay. Abby?

MS. DILLEY: Just in terms of the agenda, I think Michael has already
mentioned that there has been a slight revision, just a reordering of
how we want to approach the document and our work and if you look at the
green handout I think that reflects the approach that we want to take.

We thought it best to start with the topics as opposed to introductory
language because I think the introductory language and working on the
introduction will be \-- there would be more insight to finish \-- to
working on that if we work on the topics first and spend our time and do
the introduction tomorrow and start with the topics that either have
some confusion or had a lot of comments or were recommended for a lot of
additional language or things along those lines.

And I would say we\'d start with like 1 and 7. I think from 2 through 6
we\'ve got \-- they were more along the lines of editorial comments.
That doesn\'t mean we won\'t get to them. It just \-- I think where we
want to be at the end of the day is to have a chance to clarify some
things that really need clarification or to make sure we\'re all on the
same page on each topic and then where there is the situation where we
need to do some members think this and some members think that, some are
further along in terms of capturing that.

Others, I think we have some members think this and we don\'t have the
other members saying that so we need to make sure that we have done an
inventory of where we need to do that so that we have enough time to be
able to take advantage of working together potentially in drafting
groups and have the opportunity to review language on both situations
and those circumstances where we need to go that route.

Again, we\'re trying to come up with unified statements as much as
possible. So, we\'ll spend the time on topics most of today and up
through and past lunch perhaps this afternoon getting into drafting
groups to work further on some language to make sure we get as close to
finalized statements as possible.

We do have public comment period from 3:30 to 5:00 this afternoon and I
don\'t think we have anybody signed up at this point, but, that doesn\'t
mean that we won\'t and we encourage people who do have comments to sign
in. We will use that time for public comment.

If we don\'t use all that time then we will still work until five; we
certainly will need time; and then adjourn later today no later than
5:15 this afternoon; come back tomorrow and we\'ll probably take a sense
of, before we break today, on the status of where we are and how we want
to organize our work for tomorrow given the status of where we are at
the end of today.

Start up at 8:30 tomorrow and then continue to work basically on the
report until towards the end where we want to do two things. One is,
come back to the issue of where are we after these two days and what do
we need to do to get it done and how do we do it and what\'s our time
frame, et cetera, and then also spend just a few minutes at least, we
have, I think, 15 minutes allocated, to talk about future work and how
we want to start thinking about setting up for preparing, getting
ourselves into that new work and what that might look that and then wrap
up and adjourn no later than four tomorrow so you can \-- those of you
who need to travel can get on your way and we\'ll have in hand a plan to
complete the document.

That\'s just a very brief thumbnail sketch of the outline, the agenda,
but, I think we just will take shape and change as we need it to to
reflect where we are on the document and the progress of our efforts and
deliberations.

The only other thing I wanted to mention, I just wanted to kind of take
a step back and it goes to earlier comments that it\'s an incredible
amount of work and I think people are anxious to have a completed
document as soon as we can. In having gone through the comments and
really looking at the document and the comments, I do want to emphasize
what Michael said which is I don\'t think we\'re as far off as we think.

When you look at just the number of comments you can get a little
intimidated and say, oh my gosh, there\'s still so much work to be done,
but, then when you really sit down and look at the comments I found, at
least on, I would say more than less of the document, that really it\'s
not a question of disagreement. It\'s more \-- and I don\'t mean to
gloss over those areas where we do disagree. We need to talk about
those.

But, I would say that the majority of the document, a lot of it was the
comments were trying to make the document read better, clarify it,
really offer some language. I think people really made the effort to
problem solve and where they could find a way to try to meet the needs
of different perspectives, try to attempt language or offer language to
do that.

I think having said that I just, in terms of, you know, one of our
ground rules is to be tough on ideas and not on each other. I would flip
that to say let\'s be most generous with each other. This is at the end
of a very long process. It\'s been two and a half years to work on this
with a lot of time. It\'s kind of frightening if you really think back
on how much time you all spent on conference calls and in meetings.
It\'s a lot.

And it\'s no small task because you\'re trying to capture where the
discussion of biotech now and regarding future products. It\'s
complicated, it\'s hard, and I\'m really impressed with how much work
has been done over the last two and a half years and that we are close.
And, again, not to minimize where there are disagreements and there are
some challenges for us to really meet over the next couple of days, but,
it\'s going to take, I think, listening really to what the points people
are making rather than how they\'re saying it maybe and really trying to
find and problem solve a way to find language that everybody can agree
to, I think we\'ll make a lot of progress.

So, that\'s my pep talk for today. But, I think it\'s based on looking
at the comments and really trying to work through them; that we aren\'t
far off on a lot of the document. So, that was also just a way of
reviewing some of our ground rules too in terms of staying in one
conversation and being mindful of time limits, et cetera, and being most
generous with one another.

So, I think with that I\'ll turn it back to Michael.

DR. SCHECHTMAN: Okay. Let me just talk for a couple of minutes about the
document that\'s before you. I think we\'ve heard a few places where
there are some updates and some additional materials. I think before I
talk about \-- yes?

MR. JAFFE: We have lots of documents.

MS. DILLEY: Yeah.

MR. JAFFE: We just got one this morning. Are you talking about the one
we got this morning with the lines? I was wondering which document are
we talking about?

DR. SCHECHTMAN: I think the one that I was prepared to talk about, since
I didn\'t know about the other one that came in this morning, was the
line by line.

MS. DILLEY: The side-by-side.

DR. SCHECHTMAN: The side-by-side rather, excuse me.

MR. JAFFE: The Pat Layton compilation?

DR. SCHECHTMAN: Yes, yes, yes.

MR. JAFFE: Okay.

DR. SCHECHTMAN: And the comments that I\'m making will hopefully apply
to all of them. But, if I\'m wrong I\'m sure I\'ll \--

DR. LAYTON: This one is just one column of that same document with the
exception of one additional paragraph in topic 23 so that is \-- I just
did this document and I brought copies of it this morning just so it
would be easy to edit on with line numbers.

DR. SCHECHTMAN: Okay. Before I talk about the actual text that\'s before
you, let me just mention one useful comment that was received that was a
general comment and that is that presuming the committee emerges with a
consensus at the end of the day, whenever that day is, that there should
be an appendix listing all of the members who joined in consensus, plus,
separately, a list of all the members who contributed to the
discussions, but, who were no longer on the committee at the time
consensus was achieved.

So, with your permission, following satisfactory completion of all of
this, I\'ll just prepare that appendix and I\'m sure that will not be a
controversial piece of this document.

Now, as I talk about the various sections of the compiled side-by-side
draft I\'ll try to indicate by number or paragraph the section to which
I\'m referring. Some sections I\'ll mention only briefly if at all.
Please follow along. As you know, the document has both draft
introduction followed by draft topics of discussion. Most of the topics
of discussion follow the format of one or two topic sentences followed
by several explanatory sentences; some are longer; some are shorter.

The original plan had been to have only three or four explanatory
sentences following the topic. That, as you all know, led to some rather
long run-on sentences which have been now largely fixed with the
committee\'s permission by easing that rule. Also, some topics make
explicit reference to one of the AC21\'s earlier reports and these are
generally fairly brief.

A few of the topics, as we\'ve talked about already, have the some
believe A, some believe B format either in whole or in part. Let me talk
about some of the particulars of some of the topics. As I mentioned
earlier, there have been six open-ended conference calls since the
October plenary to discuss the text and come up with this version and,
again, thank you all for your hard work.

I\'m not going to go through the list of which call discussed which
topics and who was on each call. That\'s contained in the summaries.
Through the calls, though, almost every piece of text that\'s before you
was either discussed or arose out of those discussions. The only
paragraph that was intentionally not discussed in detail was the third
paragraph of the introduction since it describes the nature of the
consensus that the committee had reached and we\'re not there yet.

Now, nearly all the texts were sent out to committee members for comment
on December 14th and the current compilation containing the latest texts
and the comments received from AC21 members was sent out to you all on
December 22nd, slightly later than we had scheduled, but, with some time
at least for review and a significant achievement nonetheless in the
holiday season.

The introduction was gone over in considerable detail with the exception
of that one paragraph. With respect to the topics of discussion
following the introduction there are currently 29 of them. The numbers
go up to 28 but there\'s one new one which arose in discussions and that
has for the moment the fractional number 10.5.

In the text we\'ve highlighted for the committee in italics any
recommendations, however vague, that might be present in the write-ups.
Additionally, there are a few places where there are phrases highlighted
in some way or bracketed where we know there\'s going to be some
different points of view that will need to be accommodated.

As you look through the text, topics 1 through 10 were worked on by a
work group and some members felt on the call at which topic 10 was
discussed that a re-focus of 10 to strictly focus on domestic impacts
was in order and a separate topic relating to the international trade
impacts of adventitious presence for the food and feed supply chain was
necessary. That became 10.5. It was drafted by Ron Olson and Randy
Giroux but it wasn\'t vetted by other members who were on the call on
which 10 was discussed.

I\'d note that a number of members have provided comments on that that
are contained in the compilation. Topics 11 through 16 were discussed at
considerable length in work groups with topic 14 relating to non-food
uses of transgenic crops having, in part, the formulation, "some
committee members believe A and some committee members B." But, the
topic is pretty well worked through.

Topic 17 relating to FDA\'s voluntary system for regulation of foods
from transgenic plants has been very contentious over the last few years
in this committee\'s discussion so it\'s also in the A/B format.
However, I\'m pleased to note that no one provided comments on the
current formulation on that topic. The comments from one member on an
earlier formulation are included at the end of the compilation.

Topics 18 and 19 on regulation of transgenic animals and the application
of modern biotech to specialty crops respectively are now in part in
that A/B format as a result of conference call discussions. Topic 20
relating to benefits of current transgenic products was refocused by
those on the conference call so that it would fit better with the other
topics that were presented.

Members will recall that several meetings back the subject was
originally planned to be part of a discussion in the report introduction
and a number of committee members felt that its inclusion was necessary
to balance a report that in their view was largely presenting a series
of issues without enough context about the value of biotechnology for
farmers.

Two meetings back it was agreed that it would be included in the report
in an abbreviated form as one of the topics discussed. The text provided
is the current iteration. It remains a subject on which there\'s going
to need to be some further discussion here.

Topics 21 and 22 were discussed at some length in work group. Topic 23,
the mandatory labeling topic, was another topic where it\'s clear that
there\'s different strongly held views among committee members and,
accordingly, it\'s in the A/B format and was put together by Abby after
receiving input from adherents to the different views and, again, the
corrected version of that was passed out as a separate page at each of
your places this morning.

Topic 24 was discussed in work group discussions. Topic 25 was discussed
in one work group discussion and issues about it were raised in a
subsequent work group as well. It was then revised by me into a partial
"some think A, some think B" format in an attempt to address the issues
that were brought up and that will be under discussion here.

Topics 26 through 28 were discussed in work group discussions. I know
there are some divergent views on those that have emerged in the
comments and we need to take those up as well. We all know these are
going to be a challenging couple of days, some challenging discussions.
It would be very pleasing and satisfying and very important for you to
be able to meet your very difficult charge from the Secretary were you
able to come to at least rough closure on the document before you during
these two days.

Let\'s see where we can go with that.

MS. DILLEY: Carol.

MS. TUCKER FOREMAN: You know, some of these are not very controversial
and we\'ve talked about them a lot, particularly those that are in the
labeling and traceability report. Could we begin by discussing those
where we know that we\'re going to have to worry with it?

MS. DILLEY: Yes.

MS. TUCKER FOREMAN: Instead of starting with number 1.

DR. SCHECHTMAN: Yes.

MS. TUCKER FOREMAN: Thank you.

MS. DILLEY: Yes, and I also thought we might start with number 1 because
I actually think there\'s an issue that can be addressed pretty quickly.

DR. SCHECHTMAN: But not necessarily in order 1 through 28.

MS. DILLEY: Yeah. Okay. So, having said that, I think, to me, the best
way to focus that we\'re all on the same page, on the same document at
the same time, let\'s make sure we\'ve got the right documents in front
of us. So, I would suggest we use version for editing at the January
plenary, the one that Pat used, because it\'s in a line by line numbered
page document and it\'s the same document that\'s in the compiled
document but it\'s in a line by line numbered page format.

So, it\'s nothing different than what you have in this, the column, with
the exception of 23. That\'s correct. So, if we could use that.

DR. LAYTON: There\'s no color here but there is color on the screen.

MS. TUCKER FOREMAN: And the type is large enough that I can read it.

MR. GIROUX: Is that document identical to this one that you sent out?

DR. LAYTON: No.

MS. DILLEY: No, it\'s different. Let me tell you what the documents are,
okay. I know, it\'s challenging. So, this document that Pat circulated
this morning is exactly the same as this and what you can do \-- I would
have three documents in front of you. I\'d have this one and that\'s the
one we\'re going to use to reference you where you need to be, on what
page, on what topic.

This contains comments by people and as you\'ve heard we\'ve done our
best to make sure those comments show up on the column, on the
right-hand side, so you have that for your reference. This document,
Randy, that you just held up and that\'s in color, that is, and I\'ll
take the blame for it, my attempt to take the comments and offer
language as a result of those comments, okay, and I put my own comments
in there where I was confused or I didn\'t know how to resolve it or I
didn\'t know how to merge comments.

And, so, in terms of editing, I took a lot of the editing comments and
tried to do the editing with this draft. This document, as Michael said,
it has no special status other than it\'s offered as something to use if
the committee finds it useful to take the next step of polishing on the
report, great. If not, we start where we are with this document, the
original document, okay.

MR. GIROUX: And just for clarity so that I\'m almost all the way there
\--

MS. DILLEY: Good.

MR. GIROUX: \-- so the one that we got that\'s at the front of the room,
Pat, that is a side-by-side, those do not contain the comments that Greg
sent separately and passed out today so do I have to be looking at this
as well?

DR. LAYTON: I\'d have to ask Greg. I thought I had all of his comments.
Apparently not.

MR. GIROUX: Greg?

MR. JAFFE: There\'s two ways to answer that question. Two parts to it.
There was a deadline of December 20th. I was able to get through issue
17 and got to Pat the document that I had gotten, the introduction
through topic 17 by that deadline with other work considerations. The
due date was by noon on December 20th. I got it by noon December 20th.
I\'m not sure how many other people got it in by noon that day. In other
words, some may have come in afterwards. I sent to her on the morning of
the 22nd the remainder, 17 to 28.

When I looked at her compilation those were not included in the
compilation. I\'m not saying she should have included those in. I\'m
just saying I got them a day and a half later to her. I also sent that
draft on the 22nd to everybody.

So, my understanding is Pat\'s compilation does not have my comments for
numbers 18 through 28 at all included in the right-hand column so the
draft I gave you does include those done out.

The second thing was that I did do redline strikeout and although
Daryl\'s analysis came across when she did the compilation, mine didn\'t
and I, at least, when I read other people\'s, I have a hard time looking
at, and I talked to Michael and Pat about this, I have a hard time
figuring out what the changes are and, so, as a courtesy I printed that
out so that people can see more easily the red line and strikeout for
topics \-- up to topic 17.

So, those comments are included. My best figuring out was that the parts
where my comments are italics in the right are comments, you know,
discussion comments. The portions that are addressed to my initials that
aren\'t in italics are a cut and paste of my proposed changes but they
only include the additions. I mean, they don\'t show where the deletions
are. They include the additions but they\'re not underlined.

DR. LAYTON: Deletions are gone.

MR. JAFFE: Right, deletions are gone. So, those are duplicative.

MS. DILLEY: So, I mean, I guess the way I\'m looking at it is on the
compilation you have, the first cut at them, but, if you want
elaboration or there\'s some that were turned in past 17 then you have
that as a reference document. If Greg wants to offer that point and
elaborate on it, you have his comments to look at if you want to look at
it in more detail.

DR. LAYTON: And I went to graduation on Thursday morning so they didn\'t
get in.

MR. GIROUX: One additional question. Carol also sent us a copy of her
edits in this red line format. Are those incorporated in the
side-by-side draft?

DR. LAYTON: Everything that I had from Carol I tried to cut and paste
with her name because she sent them more like this \--

MR. GIROUX: Correct.

DR. LAYTON: \-- rather than on side-by-side. But, I did try to
incorporate everything I had from Carol before I said that\'s it, I
can\'t take anymore. So, what I had missed, and I\'ve already written
Carol and begged forgiveness, but, you know, there\'s only so much that
I could get in before I had to say that\'s it and send it out. I think I
got most of it.

MS. TUCKER FOREMAN: I think you did. Again, the problem is that because
I did it off another \-- off that document there are two issues. One, I
did it off not the side-by-side but the regular document. Sometimes
what\'s been crossed to help doesn\'t show up and the changes don\'t
show up in red.

Secondly, in a document I sent yesterday, just to reiterate, I actually
made a change on one of the issues that I thought might address some
concerns that were raised about the language in it and we all have to
talk about that now when we get to it later on.

So, the answer is most of them are there, Randy.

MR. GIROUX: Okay. I\'m just trying to get as few documents in front of
me as possible.

MS. TUCKER FOREMAN: Good luck.

DR. LAYTON: And this is everyone\'s comments in color if we need them
and I have the electronic version so I will just leave them sitting here
because it will get very confusing if we had all of these put up.

MR. GIROUX: It already is.

DR. LAYTON: It is confusing. I agree.

DR. DYKES: Plus, we can\'t. I guess part of my thing is, it\'s okay to
have all these comments, but, quite frankly, I don\'t know about the
rest of you, I can\'t read all these every night. Only get them one
night for the next morning. I mean, I can\'t read them all. So, I\'ve
looked at the document originally and I\'ve commented on it and, as for
me, I\'m ready to start rolling through it and if you\'ve got comments
to make we\'ll probably look at them and read them, but, I do not in any
way claim that I\'ve read everyone\'s comments and I have them all
committed to memory nor do I intend to.

DR. LAYTON: Thank you.

MR. GIROUX: To that point, for the process, as we go through these ones
side-by-side in addition to the line by line can we not race through the
individual topics and make sure that we give all of the committee
members an opportunity, a minute, to read to themselves that particular
section so that they know what they want to say?

DR. LAYTON: Absolutely. Okay.

MS. DILLEY: All right. So I would suggest that we do two things. One is
I want to start with topic 1 which is on page 8. There are just a couple
of suggestions in terms of looking of this that I wanted to bring up.
One is that, again, we just re-emphasized this, we\'re striving for a
unified description, but, where we can\'t get there we\'re trying to
clarify as best we can what some members think and other members.

I would suggest also at this point that we don\'t spend time talking
about dropping any topics. We got comments like that, but, I would say
we\'re just sticking with 1 through \-- we\'ve got 29 topics so let\'s
not spend time talking about whether we should or what ones to drop.

DR. SCHECHTMAN: For the purpose of condensing.

MS. DILLEY: Right.

MR. JAFFE: For the purpose of what? I\'d didn\'t hear what you said.

DR. SCHECHTMAN: Condensing. You know, splitters versus lumpers.

MS. DILLEY: Or just dropping period. I think we\'re going to end up with
29 topics. I think if we can just put that to rest it would be a lot
easier rather than spending time dropping or not dropping. That\'s just
my sense of it. And then also I think another principle is that we\'re
trying to reformulate recommendation language.

In other words, we\'re not \-- a lot of people offered a way around
that. We had talked about not putting recommendations in this document.
And I think there have been some really helpful suggestions as to how to
maintain the point that\'s in the italicized recommendation type
language; that that is a goal that we try and maintain the essence of it
but we take it out of a recommendation-like sentence.

So, I think those are \-- if we can stick with some of those that kind
of just puts those issues aside and we don\'t have to think about those
now. So, I mean, does anybody have problems with taking those as
assumptions before we get going? Okay.

So, with number 1, why don\'t you, as Randy suggested, take a second to
both look at it. That\'s on page 8, the compiled document. I numbered
mine and it\'s on page 14. If you want to look briefly at the comments.
I think there are a couple of things in there that need to be addressed.
I took a run at this. Again, we don\'t need to look at that right now,
just read, and I\'ll be quiet so you can read, and then we\'ll start off
in just a minute.

Has everybody had a chance to read it? So, to me, when I read this,
there are obviously some comments on this one and they\'re of a
different nature. I think they\'re editorial comments. There\'s a
comment in terms of clarifying what this topic is about, whether it\'s
about other countries\' regulatory systems or it\'s about the U.S. and I
think it\'s the U.S. regulatory system looking \-- in my mind it was \--
so we need to make that decision up front in terms of what are we
talking about exactly in this topic.

If it\'s the U.S. regulatory system then we have some comment in there
that don\'t quite match that and we need to address that and then we
have some other language issues. We\'ve got a recommendation language in
there as well so we need to do a couple of different things.

So, one of the things in my mind was the issue of whether we want to
take out the language in terms of \-- or change it in terms of other
countries\' regulatory systems.

And, Greg, I think this was your comment on this one, so, I don\'t know,
you offered \-- I can\'t remember if you offered alternative language or
I ended up offering alternative language on it.

MR. JAFFE: Yeah, I had a comment. I mean, I was comfortable with the
whole topic with the exception of the final sentence as I thought it
wasn\'t consistent with the topic statement and I suggested deleting it.
Having read your draft, the language you suggested as an alternative, is
fine with me in the spirit of compromise. But, I would also \-- my
initial suggestion had been \--

DR. LAYTON: Which is still delete it.

MR. JAFFE: \-- to delete that sentence, both because it didn\'t seem to
talk about things in the U.S. system, but, also it seemed to talk about
non-regulatory issues and the topic sentence was purely on regulatory
issues and it seemed to me procedures for preventing things and
commodities coming to the United States talked to me about segregation
and other kinds of things that are not necessarily safety regulatory
things.

But, this sentence was talking about adequate regulatory systems for
safety and those aren\'t adequate systems for safety. They\'re something
different.

MS. DILLEY: So, the language we\'re looking at is that last, the
adequacy of procedures in those countries to address adventitious
presence, et cetera.

MR. JAFFE: Yes.

MS. DILLEY: And you just want to get \-- Michael, I don\'t know if your
comment was on that. It is, okay. And then Leon. Michael first.

DR. DYKES: So, we were talking about deleting starting, "In addition
when import --"

MS. DILLEY: Yeah. That\'s the statement there.

DR. DYKES: Stop after feed system.

MS. DILLEY: After feed system.

DR. DYKES: U.S. food and feed system, full stop, and from in addition
all of the next, from lines 244, 45, 46, and 47 would be deleted. Is
that what we\'re saying?

MS. DILLEY: I think that\'s what Greg\'s proposal is, yes.

DR. DYKES: Okay. But, I was going to raise I have concerns about \-- I
agree with what Greg said. I don\'t think it relates to the topic
sentence. I also don\'t think that\'s \-- I think there\'s some
inconsistency with even what\'s said there because I don\'t think it\'s
importance of procedures in those countries to address adventitious
presence because if they\'re coming from a country you would assume
they\'re approved in that country. Therefore, they wouldn\'t be
adventitious in that country. It would be the U.S. procedures to handle.

MS. DILLEY: So, just delete it?

DR. DYKES: So, I\'m fine with deleting it. I just want to make another
rationale for why I think it needs to be \-- if we don\'t delete it, it
needs to be made accurate, so I support deleting it.

MS. DILLEY: Any concern about deleting it? Leon or Alison?

DR. VAN EENENNAAM: I think we should \-- I think what you\'ve got
written in the colorful draft as a replacement language really addresses
what we\'re concerned about which is the U.S. has to have ability to
detect unapproved events and I think that does fit into the topic
sentence so I think that\'s a good replacement sentence. So, rather than
just outright deleting it I would suggest those last four lines of topic
1 in the colorful version would

be \--

MS. DILLEY: I just want to make sure people are comfortable with that
language. Yes, Greg? Okay. He said yes. Any objections to \--

DR. DYKES: Just so I\'m clear. What are we \--

MS. DILLEY: So the suggestion on the table is if you look at that
colorful draft, which is on page 7 is \--

DR. LAYTON: Which is labeled working draft.

DR. DYKES: I\'m on page 7.

UNIDENTIFIED MALE: It\'s 247 to 249.

MS. DILLEY: It\'s that very last \-- it\'s the proposed language at the
very last of that first topic. So, it says, "In addition, when imports
of agricultural commodities are allowed from countries developing and
approving new transgenic varieties a new potential consideration is
raised: the adequacy of the U.S. regulatory system to address
adventitious presence of traits not approved in the United States."

DR. DYKES: I think that corrects the \--

MS. DILLEY: Is that technically correct? Okay. Leon?

MR. CORZINE: I would agree with that. I like your language, the colorful
language, other than I think, and there\'s several places we do this,
that we should put products in place of commodities because it might not
be the commodity. It could be the products and there are two places in
that sentence.

MS. DILLEY: Okay. Imports of agricultural products then you would say?

MR. CORZINE: Products. Yes.

MS. DILLEY: Kathleen?

MR. CORZINE: And then adventitious presence in those product shipments.

MS. DILLEY: I went with traits because Michael was trying to get us to
be consistent about traits versus \--

MR. CORZINE: That\'s fine.

MS. DILLEY: Okay.

MR. CORZINE: Oh, yes, in that one that\'s okay with me.

DR. LAYTON: Are we accepting Abby\'s language in that first line 235 on
the colorful document? We\'re not there so we\'re just talking about the
last sentence, the beginning of the last sentence.

MS. DILLEY: The last sentence, right.

MR. CORZINE: In addition.

DR. LAYTON: And the word commodities is changed to products.

MS. DILLEY: And I want to get Kathleen and Brad because your card went
up on this.

DR. JONES: If we are going to use that language then I would like to
suggest \--

DR. SCHECHTMAN: Could you speak up?

DR. JONES: I\'d like to suggest perhaps not using the term approved
given that FDA does not approve biotech products.

MS. DILLEY: Does not approve. Okay.

DR. JONES: Maybe use some of the language that Michael used under topic
10, something like satisfactorily completed all regulatory procedures
were not \--

MS. DILLEY: So that have not.

DR. SCHECHTMAN: Completed.

DR. JONES: Completed all regulatory procedures.

MS. DILLEY: Completed all regulatory procedures.

DR. LAYTON: I have a question. We\'re not talking about the U.S. in that
word? 247, is that where you\'re using the word approved?

DR. SCHECHTMAN: No, no, the very end.

MS. DILLEY: 249.

DR. LAYTON: Approved in the United States, 249.

MS. DILLEY: So the way the sentence would now read is, "In addition,
when imports of agricultural products are allowed from countries
developing and approving new transgenic varieties new potential
consideration is raised: the adequacy of the U.S. regulatory system to
address adventitious presence of traits that have not completed all
regulatory procedures in the United States." Technically correct. Brad,
did that address your comments?

DR. SHURDUT: I was going to address the topic sentence.

MS. DILLEY: Okay. Let\'s see if we can get this language and then we\'ll
\--

DR. DYKES: And I guess to be consistent that should be \-- I like the
changes so far. I think it says \-- I guess 246 \-- allowed from
countries developing and approving new transgenic varieties. Some new
improved varieties. I\'d say most approved traits. So, I think it maybe
should be transgenic traits/varieties.

DR. JONES: Most approved events, not varieties.

DR. DYKES: Most approved events, not varieties.

MS. DILLEY: Okay. Most.

DR. LAYTON: So, traits/events?

MS. DILLEY: New transgenic events or varieties?

DR. DYKES: Events. I\'d say new transgenic events.

MS. DILLEY: So, substitute the word transgenic varieties with transgenic
events.

DR. DYKES: Yes. I think that\'s more accurate.

DR. LAYTON: Okay. And that last line went that have not completed \--

DR. SCHECHTMAN: All regulatory procedures.

DR. VAN EENENNAAM: Can you use regulatory review?

DR. SLUTSKY: Technically what you should say is all necessary regulatory
procedures in the United States.

MS. DILLEY: All necessary? All regulatory procedures?

DR. VAN EENENNAAM: Applicable.

DR. LAYTON: All applicable regulatory procedures in the U.S.

MS. DILLEY: That\'s technically correct language, Bernice. Is that what
you\'re saying? All applicable regulatory procedures.

DR. SLUTSKY: Technically, none of our regulatory agencies approve. They
register things. They deregulate them. You know.

MS. DILLEY: Okay. So are we comfortable then with that last sentence now
as amended and do you want me to read it again?

MS. TUCKER FOREMAN: Uh-hmm.

MS. DILLEY: In addition, when imports of agricultural products are
allowed from countries developing and approving new transgenic events a
new potential consideration is raised: the adequacy of the U.S.
regulatory system to address adventitious presence of traits that have
not completed all applicable regulatory procedures in the United States.

DR. SLUTSKY: I have a question.

MR. JAFFE: You\'re saying events there. If you said events before
you\'ve got to say events. It\'s got to be consistent.

DR. SLUTSKY: Yeah, it\'s really events.

MS. DILLEY: Okay. Events and presence of events that have not. Okay. So
that\'s where we\'re replacing that.

MS. SULTON: Read it again.

MS. DILLEY: Yes, ma\'am. Hold on. Okay. So, let me take another run at
it. In addition, when imports of agricultural products are allowed from
countries developing and approving new transgenic events a new potential
consideration is raised: the adequacy of the U.S. regulatory system to
address adventitious presence of events that have not completed all
applicable regulatory procedures in the United States.

DR. SCHECHTMAN: Next line down, events instead of varieties. That have
not completed all applicable regulatory procedures.

MS. DILLEY: Okay. So, are we there? Are people comfortable? Okay.

MR. GIROUX: Should the word commodity be stricken from that?

DR. LAYTON: Not approved. You\'ve got to take out were not approved.

MR. GIROUX: But, then in the commodity shipment of events goes out of
there too. Right there, yeah. Of events stays. Just say shipment.

DR. LAYTON: Does it look right now?

MS. DILLEY: All right. So, other comments on this topic?

DR. LAYTON: Somebody had one that was the topic sentence I know.

DR. SHURDUT: The only thing is just a minor clarification because we\'re
talking about imported events in the topic sentence. Should we just
clarify and say regulatory systems in the U.S.? I mean, make sure we\'re
talking about U.S. regulatory systems.

DR. LAYTON: Or to have adequate U.S. regulatory systems.

DR. SHURDUT: Yes.

DR. LAYTON: Could we just put the word U.S. in between adequate and
regulatory on line 235?

MS. DILLEY: So that it\'s consistent.

DR. LAYTON: Of this document.

MS. DILLEY: Okay. Mardi?

DR. MELLON: I think the adventitious presence would be a problem not
only in the transgenic \-- in the shipments of transgenic crops coming
from those countries, but, virtually any shipment of that grain coming
from that country, right?

I mean, if people start producing transgenic rice in China then because
of the fact that they\'d be testing transgenic varieties and
contamination as a result of testing or other activities would
contaminate rice it seems to me that the adventitious problem, presence
problem would be more \-- would be associated with any of the commodity
shipments from those countries.

So, we might modify the last sentence to say the adequacy of procedures
to address adventitious presence in the commodities and shipments from
those countries of events that have not completed all regulatory
procedures in the United States.

Does that do it?

MS. DILLEY: I don\'t know.

MR. JAFFE: I\'m not sure I understand why \--

DR. DYKES: You\'re saying it may not just be a rice shipment. It could
be rice or corn.

DR. MELLON: No, I\'m just concerned, the way it reads to me they\'re
worrying about the adequacy of the procedures to address adventitious
presence in those commodity shipments of events that have not completed
regulatory review in the U.S. That doesn\'t make sense.

MR. JAFFE: We\'ve taken out the reference to commodities in that portion
of the sentence.

MS. DILLEY: Of product.

MR. JAFFE: So, there\'s no reference at all to commodities in this
sentence, only one reference to products. So, that\'s why \-- maybe \--
why don\'t you read the sentence to Mardi and see if \--

MS. DILLEY: You want me to read it?

DR. MELLON: Yes, that would help. Thank you.

MS. DILLEY: I think it captures what you\'re saying, Mardi, but, I\'m
not sure. "In addition, when imports of agricultural products are
allowed from countries developing and approving new transgenic events a
new potential consideration is raised: the adequacy of the U.S.
regulatory system to address adventitious presence of events that have
not completed all applicable regulatory procedures in the United States.
So, I think it captures \--

Okay. The other piece in here \-- okay, Carol?

MS. TUCKER FOREMAN: If you go to Abby\'s draft, the colorful draft, I
have a problem with having the standard be at least equal to the U.S.
system because I don\'t think the U.S. system\'s adequate, number one.
And, number two, it\'s not necessary there. If you take and look at
what\'s in the colorful draft, U.S. regulations and procedures for
evaluation of an increasing number of imported transgenic crops and
their products into the U.S. must ensure their food, feed, and
environmental safety.

And then I changed what Abby had next and said, and be implemented and
enforced in a manner that maintains confidence in the U.S. food and feed
system. But, even if you leave it the way Abby has it, you don\'t need
at least equal to phrase in here because we\'ve already said we want to
be safe.

DR. LAYTON: Which is why she took it out, right?

MS. DILLEY: Yes. But, the question is, is that acceptable to people and
I think it also shifts the language from recommendation-like language to
a statement basically so it takes out that issue as well. But, I want to
be sure that people are \-- we need to be sure that we\'re all
comfortable with it.

MS. TUCKER FOREMAN: The second thing I suggested was \--

DR. SCHECHTMAN: Can you repeat that again, please?

MS. TUCKER FOREMAN: Sure. If you have exactly what Abby has through the
word safety but then say and the implemented and enforced and you can
drop these regulations and procedures should includes standards.

DR. LAYTON: And at least equal to.

MS. DILLEY: No.

MS. TUCKER FOREMAN: She\'s already brought that out.

DR. LAYTON: I\'m sorry, I\'m on the wrong document. I apologize.

MS. TUCKER FOREMAN: I\'m just trying to drop some words.

MS. DILLEY: So you\'re combining those sentences to make sense.

MS. TUCKER FOREMAN: Yes. Thank you.

MS. DILLEY: Any concern with that or is that acceptable language?

DR. DYKES: I apologize. Could you just read one more time how it would
read?

MS. DILLEY: Absolutely. So, now the explanatory text under the topic
statement reads, "U.S. regulations and procedures for evaluation of an
increasing number of imported transgenic crops and their products into
the United States must ensure their food, feed, and environmental safety
and be implemented and enforced in a manner that maintains confidence in
the U.S. food and feed system."

Were there any other comments on this, on number 1, because I think from
what I understood of the comments previously that doesn\'t mean there
aren\'t any additional comments, but, that seems to address the main
comments that were made.

DR. VAN EENENNAAM: No.

DR. LAYTON: Is that it?

DR. VAN EENENNAAM: Well, you need to delete \-- you\'ve got repetition
down there.

DR. LAYTON: I think there\'s a deletion that needs to be done. U.S.
regulations and procedures needs to be deleted. That sentence.

MS. DILLEY: So, do you want me to read one more time the whole thing or
no, people are comfortable? Okay.

DR. LAYTON: I think that\'s a good one. It\'s the same.

MS. TUCKER FOREMAN: In that second \--

DR. SCHECHTMAN: No, no, you left something else out. You cut too much
off. Delete up until the italics but don\'t delete the italics. What you
were deleting except not including the italics.

DR. LAYTON: And should that be italics or can we take the italics off
now?

DR. SCHECHTMAN: Yes. Okay.

MS. TUCKER FOREMAN: Still kind of recommendation- like but at least it
doesn\'t say flat out.

DR. LAYTON: Okay. Moving on.

MS. DILLEY: All right. So, I would suggest that for now we set aside 2,
3, 4, and 5 and move to 6 because I think most of the comments on 2, 3,
4, 5 were primarily editorials, not that we\'re not going to come back
to those, but, I think our time\'s better spent on those topics up front
that are a little bit more difficult to resolve and that we need to talk
through.

So, on the version for editing at the January plenary text that\'s on
page 10 on the colorful document. It\'s page 8, number 6, topic number
6. So, it\'s the private sector, public sector funding specialty crops,
et cetera, et cetera. So, why don\'t we take a minute or two to read
through and reacquaint yourself with that particular topic on comments
which is on number 6 on the compiled document. Again, I numbered those
and that page is \-- hold on.

DR. LAYTON: It\'s 8 on these and 10 on the computer document.

MS. DILLEY: If you\'re referencing comments it\'s on page 20 of the
side-by-side if you numbered your document, but, topic 6. And when you
get to 6 you\'re on the right page.

So, I know people are still reading it. It\'s obviously a long topic
sentence to begin with and it\'s trying to do a combination of a variety
of concepts in here. It\'s an interaction between the dynamic between
private and public research as well as how that plays out on specialty
crops and trying to be clear about what specialty crops are because I
think one of the things, just generally in the document, is we were
using specialty crops to refer to a lot of different things and we\'ll
get to that in other topics. I think some of the suggestions that people
made work that out.

But, this is a hard one because it\'s a lot of different things in here
and we want to make sure that we get the topic statement and explanatory
text right.

Jerry.

MR. SLOCUM: I think Carol Tucker does a nice job saying what we mean to
say.

DR. LAYTON: I agree.

MS. TUCKER FOREMAN: Thank you. I was trying to say it\'s really not to
benefit the crops. It\'s that these things may have a benefit to the
public and I think we started trying to get through that in our
discussion.

MS. DILLEY: Carol\'s comment was on \-- it\'s two pages. If you\'re
looking at the compilation document it\'s two pages past the actual
topic on the left-hand column and it\'s the last set of comments on that
particular topic in the compilation document. And it\'s language, if you
look in the colorful draft, is inserted into the \--

MS. TUCKER FOREMAN: Yeah, most of it.

DR. LAYTON: Yeah.

MR. SLOCUM: Most of it\'s in Abby\'s?

MS. TUCKER FOREMAN: Yeah, most of it\'s in Abby\'s.

MS. DILLEY: The colorful document.

DR. LAYTON: And I think what you did, Carol, was eliminate the last
sentence, but, Abby, I don\'t think you did.

MS. DILLEY: Okay.

MS. TUCKER FOREMAN: I thought she did.

DR. LAYTON: It\'s still in italics, right?

MS. TUCKER FOREMAN: Oh, I\'m sorry.

DR. LAYTON: So, I think the difference was

that \--

MS. DILLEY: We\'re just starting with the topic statement. Why don\'t we
start with that.

DR. SHURDUT: How far does that go? It\'s hard to tell with the bullet.
Does it include "that transgenic?"

MS. DILLEY: Yeah, you\'re right, it does. It goes all the way down to,
"also is scarce."

DR. LAYTON: 313.

MS. DILLEY: If we could start with the topic statement and then \--

DR. LAYTON: It goes all the way down though, Cindy, to \--

MS. SULTON: I know. Just look at the topic part.

MS. DILLEY: So, Jerry, your comment may have been to all the text and
editing. I wasn\'t sure. But, I thought we\'d start with the topic
statement.

MR. SLOCUM: The topic statement and the rest of it.

MS. DILLEY: And the rest. Okay.

MR. SLOCUM: All of it.

MS. DILLEY: That we could just take \-- yeah, yeah.

MR. SLOCUM: Just that it\'s a much simpler approach to me and I think it
states the intent of the committee.

DR. DYKES: I would concur.

MS. DILLEY: Carol\'s recommended language?

DR. DYKES: Which I understand was the same thing as what you got in your
colorful document at page 8, right?

MS. DILLEY: Yeah, and then would you just delete the italicized last
sentence.

DR. LAYTON: So, pick up lines 307 through half of 320 from Abby\'s
document and move it instead. So, if that\'s Abby\'s document it stops
at the italics.

MS. DILLEY: Right.

DR. DYKES: I\'m fine with this document and I\'m also fine with that
bringing additional benefits such as market system bringing priority to
USDA. I\'m fine with the last sentence too.

MS. TUCKER FOREMAN: The thing is that\'s a recommendation and it\'s
really redundant because it said before that you get some benefit.

DR. DYKES: I\'m fine with deleting it too. Oh, yeah.

MS. DILLEY: Okay. Leon?

MR. CORZINE: Abby, I agree. I think that language is good. A question I
have in the interest of wordiness, do we need publicly funded research
general and public research specifically or can we just say public
research?

MS. TUCKER FOREMAN: It\'s fine by me.

DR. SCHECHTMAN: Where?

MR. CORZINE: At the beginning of Carol\'s sentence. With publicly funded
research generally and public research specifically. Everybody would
pretty well get it, wouldn\'t they? Or, if somebody has heartburn it\'s
not a big thing, but, I just thought it would be much simpler to just
say public research aimed at.

MS. TUCKER FOREMAN: Yes, yes.

MS. DILLEY: If people think that\'s better, definitely.

MS. TUCKER FOREMAN: Yes.

DR. LAYTON: Are you talking line 314? I\'m not sure where you are.

MR. CORZINE: No, where I am is \--

MS. DILLEY: Yeah. So, it\'s the second statement of explanatory text.

MR. CORZINE: Let\'s work with Carol\'s language, okay?

DR. LAYTON: Carol\'s language, okay.

MR. CORZINE: The second sentence.

UNIDENTIFIED MALE: I like Carol\'s.

MR. CORZINE: The second sentence.

DR. DYKES: I thought it was on the same language.

UNIDENTIFIED FEMALE: Does it begin with the word transgenic?

MR. CORZINE: No, it begins with the word publicly funded research
generally.

DR. LAYTON: In the non-bold text.

MR. CORZINE: Right, right.

DR. LAYTON: Halfway through the line.

MR. CORZINE: Third line down.

MS. DILLEY: And so your language again, Leon?

MR. CORZINE: Just you scratch publicly funded research generally and you
start the sentence with public research and scratch specifically.

MS. DILLEY: Okay.

MR. CORZINE: Public research aimed.

MS. DILLEY: Got it. Got it.

MR. JAFFE: No, because you need to fund it.

MR. CORZINE: It\'s public research.

MR. JAFFE: But, the whole point of this is it\'s funded by the public as
opposed to funded by the private. I mean, there are many \-- what is
public research? If you work in a public university but you get funded
by the private sector. We\'re talking here a distinction between
privately funded research and publicly funded research so, I mean, I
think you need the word funded in there.

The whole point of this is funding.

DR. LAYTON: Publicly funded research aimed at the development of new
varieties. You\'re okay? Compromise?

MR. CORZINE: It\'s fine.

MR. JAFFE: I\'m just \--

DR. LAYTON: I\'m asking. Publicly funded research aimed at.

MS. DILLEY: So, now that reads publicly funded research aimed at the
development of new varieties has remained static over the past several
years.

MR. JAFFE: But, the colorful version is not the same as Carol\'s
version.

DR. LAYTON: As Carol\'s comments.

MR. JAFFE: So, I think it is not the same.

MS. DILLEY: You like Carol\'s comments.

MR. JAFFE: Right, so, we shouldn\'t \-- right, so, I\'m just telling her
it\'s not the colorful version.

DR. VAN EENENNAAM: This is on the side-by-side version actually. It\'s
not the original.

DR. LAYTON: Yeah, it\'s not the original. She would have to have eight
documents pasted in front of her.

DR. DYKES: I\'m not sure we\'re going to be able to do this via a
computer. The only thing we can do with a computer is we\'re editing as
we go. I mean, it\'s helpful to have as a guide.

DR. SCHECHTMAN: We\'ll see as we go. It may sometimes not work, it may
sometimes work.

MS. DILLEY: Okay.

DR. SCHECHTMAN: Where it\'s useful, we\'ll do it.

DR. DYKES: If that\'s the document we\'re editing you can do it, but,
that\'s not necessarily the document.

MS. DILLEY: Right.

DR. SCHECHTMAN: Well, we\'re pulling things from various different
places.

DR. LAYTON: This is the document we\'re editing, but, where we get the
data is from many different places, so, but, I\'d like to walk out of
here with one edited document when we get done, so it incorporates all
the edits that we\'ve all agreed to.

MS. TUCKER FOREMAN: Do I understand then that we\'re using the language
that I suggested with the changes made by Leon?

MS. DILLEY: Yes.

DR. LAYTON: It is there but it\'s not up on your screen so you\'re just
going to have to type it in.

MS. DILLEY: She\'s doing that.

DR. LAYTON: She\'s typing it in.

MS. DILLEY: So, we\'re all on the same page. We\'re just catching up
electronically. Carole and then Mardi.

DR. CRAMER: I have a suggestion on the next one. Just to shorten it, the
next one.

MS. DILLEY: The next one what?

DR. CRAMER: The next sentence. The one sentence starting as a result.

MS. DILLEY: Okay.

DR. CRAMER: I don\'t know that we need "are not able to attract research
personnel." You read that sentence, crops don\'t attract. I think we
just ask that.

MS. DILLEY: So just take out the clause and are not able?

MR. SLOCUM: But, I think it\'s an important thing to realize that if
there\'s not funding then they\'re not going \-- there\'s not going to
be research done and I think that\'s what \--

MS. TUCKER FOREMAN: That\'s where we started out.

MR. SLOCUM: Yeah.

MS. TUCKER FOREMAN: It maybe said that, but, that was the reason we were
talking about it.

DR. LAYTON: Could I suggest, therefore do not attract research
personnel?

MS. DILLEY: Mardi?

DR. MELLON: I just have a clarifying question. Is it the case that
funding overall for the specialty crops is adequate except for the
research that would involve the use of genetic engineering? I mean, it
seems to me that the general argument that big crops are for bigger
returns and, therefore, attract more research is true across the board.

DR. DYKES: Not just biotech you\'re saying?

DR. MELLON: Not just biotech. So, we kind of start out with a general
rationale that \-- but, then we\'re

\-- I mean, are we \-- I really \-- I don\'t mind it the way it\'s
written. I don\'t mind pointing out that there are these big crops,
small crop problems and a kind of a market dysfunction here that the
public should address, but, it just seems that we might want \-- you
know \-- we might want to say something that, you know, they need more
research overall including or something like that.

DR. LAYTON: Mardi, I would \-- I mean, looking at our university just as
an example, I think that we do research at a certain level on many of
what I consider as minor crops. For example, blueberries or peaches or
some of the other things that I\'m very familiar with. And you can do
those if you can make some progress with a lot less money because of the
kind of research you do.

It\'s when you take that step up to the genetically engineered or the
biotech improved the cost of it gets way beyond what a university \-- we
always call bootstrapping or, you know, doing it for a little bit of
money. There are a little bits of money that Hatch and McIntyre sent us
to do a good bit of research, but, for example, I mean, we get about a
half a million dollars and McIntyre sent us money to do forestry
research but a half a million dollars doesn\'t even begin to start on
focusing on a genetically engineering project on loblolly pines.

So that, I think, is the bigger issue. It\'s that while we can do
research at a certain level it\'s one thing, but, when you hit that
genetic engineering level the cost of it is exorbitant.

DR. VAN EENENNAAM: I think the way the final sentence reads from
Carol\'s draft here is not really germane necessarily to what this
particular group\'s about and, i.e., biotech or genetic engineering, and
I actually think back to the colorful version. Abby inserted a little
thing there that says in that final sentence of bringing the advantages
of \-- excuse me \-- some of these specialty crops, including forests,
trees, vegetables, and fruits might benefit from advances in, and I\'m
going to insert biotechnology here to cover certain people\'s concerns
about including marker-assisted selection and other type things.

If you put might benefit from advances in biotechnology if adequate
research funding was available, then it kind of focuses it back rather
than just we should do more research on loblolly pines to biotech
research on those specialty crops.

MS. TUCKER FOREMAN: The problem that I have with that, and I know where
you\'re trying to go and I think it\'s okay, but, if you start with the
crops may benefit I don\'t think we\'re making an argument that perhaps
lays as you might say, with the public. If you say the public benefits
from the development, could benefit from the development of these crops
then you can change it to be more specific, biotechnology, and I\'m fine
with that.

DR. VAN EENENNAAM: Oh, okay. I don\'t mind could provide public
benefits. I guess \--

MS. TUCKER FOREMAN: Yes. Okay. I don\'t mind your suggestion. I just
want to be sure.

DR. VAN EENENNAAM: Could provide public benefits.

DR. LAYTON: So, for my benefit it would be could provide public
benefits.

DR. VAN EENENNAAM: Yeah, where that \--

MS. SULTON: I\'ll make it bigger. Sorry.

MS. DILLEY: So, it reads some of these specialty crops, including \--

DR. LAYTON: You did it right. It just jumped down on you.

MS. DILLEY: Some of these specialty crops, including forests, trees,
vegetables, and fruits could provide public benefit from advances in
biotechnology if adequate research funding were available.

MS. TUCKER FOREMAN: That\'s fine.

MS. DILLEY: So I think it captures what you\'re all saying.

MS. TUCKER FOREMAN: You know, with the dietary guidelines saying we need
to eat more fruits and vegetables obviously if we had ways for them to
stay fresh longer.

DR. LAYTON: Or don\'t have root rot or blights.

MS. DILLEY: Okay. Any other comment on number 6?

DR. DYKES: I don\'t know if that reads right.

MR. JAFFE: I don\'t know if that reads right.

MS. DILLEY: The last sentence or the whole thing?

MR. JAFFE: The last sentence.

MS. DILLEY: Okay. We have, "some of these specialty crops" and then
elaborates on what those specialty crops are, "including forests, trees,
vegetables, and fruits could provide public benefit from advances in
biotechnology if adequate research funding" \-- is it public research?
If adequate research funding were available.

So, if adequate research funding were available \--

MR. SLOCUM: But, the advances in biotechnology is in the wrong place.
That belongs after fruits, doesn\'t it? Yeah. What if it read, "some of
the specialty crops including trees, vegetables and fruits might benefit
from advances in biotechnology and to provide public benefits if
additional public research funding were available? Might benefit from
advances in biotechnology and?

MS. TUCKER FOREMAN: Why not say improvements. Use the word agricultural
biotechnology might provide improvements in these specialty crops or
provide public benefits if more research funding were available.

DR. LAYTON: It\'s probably modern biotechnology. I like that. Modern
biotechnology.

DR. VAN EENENNAAM: Didn\'t we define that as being genetic engineering?

DR. LAYTON: I\'m sorry, you\'re right. It\'s biotechnology. Just
biotechnology.

DR. SCHECHTMAN: Advances in biotechnology.

MS. TUCKER FOREMAN: Improvements provided through.

DR. SCHECHTMAN: Improvements provided through advances in biotechnology
might.

MS. TUCKER FOREMAN: I\'m sorry, I turned it around. Advances in
biotechnology could provide improvements in some of the specialty crops.
Advances through biotechnology.

MS. DILLEY: Let\'s make sure we\'ve got it. Advances through
biotechnology could provide improvements to these specialty crops.

MS. TUCKER FOREMAN: Or in some of the specialty crops. I\'m reading off
the screen, Abby. Including et cetera. And provide public benefits.

DR. CRAMER: How about just saying yielding public benefits.

MS. TUCKER FOREMAN: Yielding public benefits if research funding were
available.

MS. DILLEY: All right. Any other comment on number 6? Okay. So, advances
through biotechnology could provide improvements in some specialty crops
including et cetera yielding public benefits if adequate research
funding were available. Okay.

DR. LAYTON: And the rest of it gets deleted down below there?

MS. DILLEY: All right. That was 6. I would suggest, and this is a little
bit more challenging, as if these other two weren\'t, but, go to 7.

MR. SLOCUM: We were trying to guess where you were going. That\'s all.

MR. JAFFE: If you have a road map of where we are going to go it would
be helpful for us to know. When you have a minute if you\'re not \-- you
can look at other things and start to prepare yourself.

MS. DILLEY: No, I would say \-- I can give you the next one but don\'t
read it yet. It\'s 7 and then I\'m going to 10.5.

MR. JAFFE: Okay.

MR. SLOCUM: We\'re in 7 now?

MS. DILLEY: Seven now. So, why don\'t we take a couple \--

DR. LAYTON: And I'm keeping a scorecard of what we completed here.

MS. DILLEY: Do you want to take a break now? Why don\'t we take \--

DR. LAYTON: Five minutes.

MS. DILLEY: For those of you who want to read and take a break while we
do that but we\'ll start out \-- we\'ll take kind of a long break.
We\'re going to take 15 minutes to stretch your legs.

DR. LAYTON: Five minutes.

(Whereupon, a brief recess was taken)

DR. LAYTON: Okay. If we could get seated. We\'re making significant
progress, two in an hour.

MS. DILLEY: So, we\'re reviewing 7 which is on page 11 in this document.
On the colorful document it\'s 9, page 9, and on your compilation
document it\'s page 22. Topic 7.

DR. LAYTON: Future of modern biotechnology. And, Greg, I think on your
italics here is the bold part, impacts of modern transgenic organisms
and it must be that first sentence that you were doing editing on.

MS. DILLEY: So, there are a lot of comments on this one and some of them
are editorial, some of them are to address the recommendation-like
language, as well as some other comments. And we have cards up already.
Carol, was your card up before?

MS. TUCKER FOREMAN: Well, before it fell down, yes.

MS. DILLEY: Okay. So you are up. Okay. So, Carole, Michael, and then
Carol. So, Carole Cramer, you want to start and then Michael and then
Carol Tucker Foreman.

DR. CRAMER: So, I could have looked at Carol Tucker Foreman\'s responses
and several other responses and I know you\'re reluctant to try to
change the statement that we\'ve already come up with. I have an idea
which would be just a concern, or the issue is that there\'s really a
paucity of available objective, non-biased information on the impact of
uses of biotechnology.

If we sort of say it that way, that as opposed to the future depends,
which has all of the ramifications, we could say the real issue is that
there\'s a paucity of unbiased objectives we may be able to dissipate
some of the emotions of the later statement.

DR. LAYTON: So, there is a \--

MS. DILLEY: Did you have specific language?

DR. CRAMER: Yes. There\'s a paucity of objective, unbiased information
on the use and impact of transgenic organisms.

MS. DILLEY: There\'s a paucity of objective and unbiased information on
the use and impact of transgenic organisms.

MS. TUCKER FOREMAN: Analysis rather than information. I don\'t care. I
think it\'s a terrific idea.

MS. DILLEY: So, it\'s objective and unbiased information or analyses?

DR. VAN EENENNAAM: I think I was going to say instead of analysis or
instead of \--

DR. CRAMER: Information.

DR. VAN EENENNAAM: No, unbiased put objective analysis.

MS. TUCKER FOREMAN: Yeah.

MS. DILLEY: There is a paucity of objective analysis?

DR. VAN EENENNAAM: Whatever Carole had it first.

DR. LAYTON: There is a paucity of objective analysis.

MS. DILLEY: Unbiased information?

DR. LAYTON: No, she was taking unbiased information out.

DR. CRAMER: How about objective and unbiased analyses?

MS. TUCKER FOREMAN: I think she\'s objecting the word unbiased and I
think it\'s okay to drop that and understandable might be one of the
words you use.

MS. DILLEY: A paucity of objective analyses?

MS. TUCKER FOREMAN: Yeah.

MS. DILLEY: Analysis?

DR. SCHECHTMAN: Analysis.

DR. CRAMER: Analyses. The plural. It\'s the plural.

MR. JAFFE: I mean, it\'s the Department\'s data. I mean, the data
analysis.

DR. MELLON: Yeah, I want to separate data from analysis.

DR. LAYTON: Objective data analysis.

DR. DYKES: No, objective and \--

DR. LAYTON: Objective analyses.

MS. DILLEY: Of data and objective analyses on the use and the impact of
transgenic organisms?

DR. SCHECHTMAN: Impacts.

MS. DILLEY: Impacts.

MS. SULTON: You\'ve got use and \--

DR. LAYTON: You\'ve got use and impact twice Cindy said.

MS. DILLEY: No. Oh, I\'m sorry. So now it reads \-- now that the topic
statement reads, "There is a paucity of data and objective analyses on
the use and impacts of transgenic organisms."

DR. VAN EENENNAAM: On U.S. agriculture?

UNIDENTIFIED FEMALE: That\'s implied.

DR. DYKES: When we say on the use of what do we mean? How much has been
out there?

DR. CRAMER: Yeah, how much has been out there.

DR. DYKES: Are we saying that there\'s a paucity, there\'s just
absolutely no information out there on how much has been done?

MR. JAFFE: How they\'re used and not necessarily acres. Not necessarily
the acres. There\'s information about how many acres are grown but how
they\'re used and their impact.

MR. GIROUX: I\'m just very confused by that sentence because I don\'t
know what it means. I mean \--

MS. DILLEY: So maybe on the impact stuff as opposed to the use of?

MR. GIROUX: Is that on environment? Is that on diet? What?

DR. SHURDUT: It was initially benefits.

MS. DILLEY: On the impact. Well, doesn\'t impact cover the benefits too?

DR. LAYTON: No.

MS. DILLEY: Is impacts downsized?

MS. TUCKER FOREMAN: I\'m okay with saying benefits here.

DR. LAYTON: Okay. Instead of the word use?

MS. DILLEY: Benefits and impacts of transgenic organisms?

MS. TUCKER FOREMAN: The broader impact?

DR. CRAMER: On the broader impact. I mean, just saying the broader
you\'re talking about acreages.

MS. DILLEY: So, broader impacts of transgenic on the broader benefits
and impacts? What are we doing?

DR. VAN EENENNAAM: Benefits and broader impacts?

MS. DILLEY: On the benefits and broader impacts?

DR. CRAMER: Broader benefits. Broader benefits and impacts.

MS. DILLEY: So, broader is clarifying benefits and impacts. So, now it
reads, there is a paucity of data and objective analyses on the broader
benefits and impacts of transgenic organisms.

DR. VAN EENENNAAM: Benefits and impacts. After broader put benefits and.

MS. DILLEY: Randy, any comment on that topic or on that sentence?

MR. GIROUX: First, the word paucity, I think we should replace it with
something \-- you know \-- is that the same as dearth or, you know, I\'m
not \-- I don\'t know how many sesquipedalians there are out there \--

MS. DILLEY: Whatever you think.

MR. GIROUX: I guess I\'m struggling with the sentence because knowing
that the International Life Science database includes over five to six
hundred peer-reviewed journals on impacts and benefits that come from
biotechnology. I was struggling with that sentence.

You know, I guess it all depends on what are you calling unbiased piece
of information. If you think all research articles are biased pieces of
information then that\'s true. If you don\'t \-- I mean I\'m struggling
with making that statement knowing how many articles come out about
agricultural biotechnology, how many scientific citations are released
on a monthly basis around this topic that we could make such a
statement, that there\'s no information about biotechnology.

I just don\'t get it.

MS. DILLEY: So you could flip that to a positive in saying there\'s a
need for greater \-- there\'s a need for much more data and objective
analyses, or, I don\'t know. Is that what you\'re suggesting?

MR. GIROUX: No, I think there\'s a lot of that going on. I\'m not sure
that\'s a factual statement.

DR. SHURDUT: But, I think the driver of that wasn\'t it USDA in the
unique role they have in development of data so it goes beyond other
data than USDA has.

MS. TUCKER FOREMAN: The official \-- I think that we don\'t want to use
that word, but, that\'s what you\'re saying, in the absence of publicly
funded, publicly sponsored.

DR. SHURDUT: And then going forward, USDA has a role to continue to
generate that data.

MS. TUCKER FOREMAN: Publicly sponsored.

MS. DILLEY: Publicly sponsored data and objective analyses, is that what
we\'re trying to insert there? Do you think the notion of government
linked research \-- Alison, go ahead.

DR. VAN EENENNAAM: I\'m not sure that I actually agree with Randy\'s
comment that there\'s a lot of pure data out there. For example, on the
effects of GE on herbicide use, I mean, you\'ve got kind of the two
camps that cite their favorite guys, both of whom are not pure good
science literature. There\'s actually, if you go look, there\'s not that
much science pure literature out there on the effects and, you know,
USDA you know has herbicide databases, how much herbicide.

I mean, they have a really unique data set that, to me, is where you
could logically look and say, well, what has been the effect on ten
years of GE. You know, we certainly can look. I forget the names of the
guys. Benbrook and Gianessi are two. I forget who\'s who, but, you know,
that\'s kind of the two that get brought up depending on whose camp
you\'re in and there\'s not that much objective stuff.

MR. GIROUX: I guess \-- I\'m sorry to interrupt. I guess my struggle is
this is a very general statement and I think in some specific areas
there are two camps and they\'re, you know, battling it out, but, I
think in some of the areas there\'s a lot of information.

DR. DYKES: I don\'t think that\'s what I heard you saying. What I
thought I heard you saying, which I think, to me, clarified what the
real issue here is, is that you\'d like to see the information for which
USDA already has. You\'d like to see them put that together in an
objective analysis and make it publicly available. That\'s what I heard
the request being, which I don\'t think that\'s what that sentence says.

MR. GIROUX: Right. That\'s the request.

DR. DYKES: That\'s what the paragraph says.

DR. LAYTON: Yes, that\'s what the paragraph is all about.

MR. GIROUX: So the topic sentence is the problem.

MS. DILLEY: Carol Tucker Foreman and then Jo.

MS. TUCKER FOREMAN: Well, I think they improved the topic sentence
substantially and I was \-- that made me a lot more comfortable with it
so I would just, this is minor but important, I\'m looking at the
colorful document and it says that the application of modern
biotechnology has had numerous impacts on U.S. agriculture and the food
and feed chain.

I don\'t think it\'s had substantial impacts on the food chain, on
crops, on commodities, but, not on the stuff that I buy. So, we just
need to \--

DR. LAYTON: Add that piece.

MS. TUCKER FOREMAN: Yeah, we just need to \--

DR. LAYTON: We haven\'t accepted her piece.

MS. TUCKER FOREMAN: It just needs to be massaged a little bit.

MS. DILLEY: Okay. So, when we get to the explanatory text let\'s make
sure we get the topic statement right. So, we need this notion of the
USDA pulling together data or providing public information and I\'m not
sure where they are. So far we\'ve got there is a paucity of publicly
available or sponsored data and objective analyses on the broader
benefits and impact of transgenic organisms.

I\'m still not sure that that gets to where the last conversation went.
Jo, do you have \--

MS. TUCKER FOREMAN: Sponsored and available I think.

MS. DILLEY: Sponsored and available.

DR. HUNT: Reading the topic sentence and then looking at the detailed
paragraph what to me seems to be missing in the topic sentence was the
communication \-- was a communication of the data. I don\'t know how
much data is really out there, but, it\'s the collection of that data
and then communicate to the various stakeholders in the future and I
think we should try and capture the communication aspect in the topic
sentence.

MS. DILLEY: So, Carol Tucker Foreman just added there\'s a paucity of
publicly sponsored and available data. Available doesn\'t get to the
more proactive of communicating, but, I don\'t know if that\'s what
you\'re looking for.

DR. HUNT: Could you put communicated, analyses communicated and the
broader detail about that?

MS. DILLEY: I don\'t know if that gets \-- Jo, I\'m looking at you
because there\'s a paucity of publicly sponsored and available data and
objective analyses. I\'m not sure again that gets where you want to go.

DR. HUNT: In terms of the communication end, yes. I mean, I really
don\'t know how much data is out there, whether there\'s a big gap in
there, I don\'t know, and it seems to be it depends on which specific
area we\'re looking at, but, that would seem to address the fact that
whatever data is out there is not currently communicated in a safe world
(sic) fashion.

DR. LAYTON: In looking at what Cindy\'s trying to write, I would have
said it was there\'s a paucity of public communicated data and objective
analysis on the broader benefits and impact of transgenic organisms. And
drop the word sponsored. Publicly communicated.

MS. TUCKER FOREMAN: No, there\'s a lot of communication from private
sources.

MS. DILLEY: Alison and then Mardi.

DR. LAYTON: I don\'t like the way the sentence is structured.

DR. VAN EENENNAAM: Can I just suggest moving communicated to the paucity
of publicly sponsored data and objective analysis communicated to \--
communicating the broader benefits and impacts of transgenic organisms?

DR. LAYTON: Yeah, communicating the broader benefits.

MR. JAFFE: If you\'re going to add communication it should be added at
the end of the sentence. Say the paucity of publicly sponsored data and
objective analysis on the broader benefits and impacts of transgenic
organisms that gets communicated, or, that needs to be communicated or
something.

MS. DILLEY: Yeah. So, the notion of communication as in the topic
sentence should be at the end because otherwise it gets a little
confusing.

MR. JAFFE: Yeah. Two different issues.

MS. DILLEY: Okay. So, now, right now it reads, there is a paucity of
publicly sponsored data and objective analyses. The broader benefits and
impacts of transgenic organisms that is communicated.

DR. VAN EENENNAAM: That is being \-- I don\'t know. That is being \--

MS. ZANNONI: I think you\'re missing too much.

MS. DILLEY: We are. We\'re trying to jam a lot in that topic sentence.
Mardi?

DR. MELLON: I think we need to separate. There are three issues here.
One is the collection of data on how many acres are used, how much, you
know, the amount of pesticide that\'s used, the size of farms that, you
know, use it, whatever data that are \-- there\'s a need to collect
data.

The second is that there\'s a need to analyze those data. That is a big
\-- that\'s what Benbrook and Gianessi do. You know, they go out and
they look to see whether they can connect the use of biotech with the
increase or the decrease in the amount of herbicide. That is a very
complicated process. It can be done in all kinds of different ways. It
depends on the questions you ask, you know, really the kinds of analyses
that you get.

The third is that whatever analyses are produced, you know, need to be
communicated. I would say that we would want to actually take
communication out of this. This is advice to the USDA. I\'m
uncomfortable with the notion that the USDA is kind of a communicator of
analyses of data.

What I\'d like to emphasize is what USDA can do uniquely and that is to
collect the data on which the analyses are based. So, I\'d like to \--
and then I\'d like \-- and that\'s where I think the emphasis of the
piece should be, that USDA should be encouraged to continue to do that.
I mean, it has the best, certainly on American agriculture the best data
set out there and it could be made even better.

In addition, I think, as we said here, USDA has an important role in
encouraging external, independent, peer reviewed analysis of the data
that it collects. Rather than doing the analysis itself it ought to
encourage the Gianessis of the world, the Benbrooks, all of these other
people, to analyze the data but to do it in, you know, hopefully it
would be much better if it were done in peer reviewed publications where
people could kind of battle those differences out.

So, and then, as I said, I think we should just leave communication out
of this issue because it\'s a very problematic \-- you know \-- it\'ll
get us all tied up with, you know, what the communications are for. So,
I\'d like to suggest that we \-- that we change the topic to, you know,
there is a need for objective data on the use and impact of transgenic
organisms on which to base \-- no, wait a minute.

There\'s a need for objective data on which to base the analysis of the
impacts of modern biotechnology. And then we can just \-- that would be
a topic sentence and then we can \-- I mean, I\'m comfortable with most
of the rest of what\'s in the explanation here.

But, I don\'t necessarily think there\'s a paucity of that raw data
right now. I think there actually is quite a bit of it out there but I
would like to encourage, you know, in a general way USDA to collect even
more, but, also to separate that collection function from the analysis
function.

MS. DILLEY: Okay. Michael and then Carol.

DR. DYKES: I would have a suggestion. I\'m more along the lines of where
Mardi is. I would suggest that another suggestion for the topic sentence
that incorporates I think some of what we already have, but, I think
tries to encompass the discussion. The future of modern biotechnology
depends upon the availability of data, availability of data, objective
peer reviewed analysis of the data, communications of the information on
the use and impact of transgenic organisms in a manner that the public
can understand.

DR. LAYTON: Okay. Slowly.

DR. DYKES: The future of modern biotechnology depends upon and then I
would insert the availability of data, the objective peer reviewed
analysis of data, and communication of the information on the use and
the impact of transgenic organisms. I\'m just trying to pick up the
language that\'s already there.

DR. LAYTON: Communication of what? What\'s the next word again?

DR. DYKES: Communication of the information on the, and then pick up the
use and impact of transgenic organisms, the last few words of the
original text. Okay. Information on the use and impact of transgenic
organisms in a manner that the public can understand.

MS. DILLEY: Because I think that to your concept, I think that Mardi and
you are both on the same relative wave length. I think that Mardi\'s
right in terms of there are three different issues here. There\'s data
collection. There\'s analysis. And then there\'s the public information
communication. I think communication is seen very differently by people
around the table.

I think if we can stick with publicly available information we\'ll make
a lot of progress. I think the notion of communication we talk about in
other topics and if we don\'t pick it up we should come back to this
one, but, that one seems to be a harder one to crack.

I mean, if it\'s publicly available information on which to base the
analyses, *et cetera*, I think we make a lot more progress if we have
those three different dimensions of it and we talk about it as publicly
available or public information rather than get into it\'s
understandable by the public or it\'s communicated to the public because
that\'s where I think where we run into some trouble.

That\'s my own observation on various comments.

DR. DYKES: I\'m trying to say the same thing as Mardi so I may have done
a poor job saying it, but, in spirit \--

MS. DILLEY: No, I think you are right. I think you are relatively in the
same ballpark, so, a couple of cards went up. Carole Cramer, then Leon,
then Duane and Lisa.

DR. CRAMER: Actually, if we just move the screen down a little bit. I
had, even before Mardi talked, another possible one which just would
replace a paucity with there is a need for more publicly sponsored data
collection and objective analysis that would compromise what she had as
well, but, more \--

MS. DILLEY: Publicly sponsored data collection?

DR. CRAMER: Publicly sponsored data collection have and objective
analyses on the broader benefits, impacts and importance.

MR. JAFFE: Period.

DR. MELLON: I wouldn\'t say they\'re necessarily benefits. I think we
should just say impacts. We need to know what the impacts are, whether
they\'re beneficial or not.

MS. TUCKER FOREMAN: But, the question is what \--

DR. MELLON: And that\'s what\'s occurred to the analysis is, you know
\--

MS. DILLEY: Can you just say analyses of modern biotechnology?

DR. MELLON: On the impact. I mean, I think we do need objective analysis
of the impacts.

MS. DILLEY: Well, I think the challenge on that language is that some
would view impacts as being negative, right, so, we\'re trying to \--

DR. MELLON: Having any impact is a negative?

MS. TUCKER FOREMAN: You don\'t view it as negative, do you, Carole?

DR. CRAMER: No. Impacts can be positive or negative. They generally are
both.

MS. DILLEY: Carole Cramer, let me make sure I\'ve got your suggested
sentence. There is a need for more publicly sponsored data collection
and objective analyses of the impacts of modern biotechnology?

UNIDENTIFIED FEMALE: Of the broader impacts.

MS. DILLEY: Of the broader.

DR. CRAMER: Broader impacts.

DR. MELLON: Broader than what?

DR. VAN EENENNAAM: And take out benefits.

MS. DILLEY: I think, Mardi, I heard you say what do we mean by broader,
I think it\'s kind of a nod to the fact that there\'s data out there,
there\'s analyses out there, but, we need \-- no?

DR. MELLON: But, we can say there\'s a need for objective data. I mean,
publicly collected objective data on which to base analyses of the
impacts of modern biotechnology. There is a data collection something
and then there\'s \--

MS. DILLEY: So there\'s a need \--

DR. MELLON: \-- analysis function.

MS. DILLEY: So, then if we took that out I\'m still trying to find the
right sentence. There\'s a need for more publicly sponsored data
collection and objective analyses \--

DR. MELLON: On which to base the objective analyses of the impacts of
modern biotechnology.

MS. DILLEY: Objective analyses of the impacts of modern biotechnology.
Okay. Let me get to some of the other comments I don\'t want to bypass.
Yes, Leon, you were next.

MR. CORZINE: I wonder if what we\'re trying to say here, the two things.
We want peer reviewed and publicly available, okay, and if we can focus
on that. Maybe we insert that in Carole Cramer\'s here. There\'s a need
for more and maybe we don\'t even need more in there. Maybe we need peer
reviewed, publicly available. We don\'t need more data and public data
collection. We just need it peer reviewed and we need it publicly
available. Right?

DR. CRAMER: Well, I think we need more data and then we need more
publicly \--

MR. CORZINE: Well, I guess I wouldn\'t necessarily agree with that
because there\'s a host of things going back to what Randy mentioned.
There is a lot of data out there.

MS. DILLEY: Say your statement again, Leon.

MR. CORZINE: Well, I haven\'t wordsmithed it well enough yet, but, I
think the focus needs to be, it needs to be peer reviewed and USDA\'s
role, I guess, is question, and publicly available. And if it\'s peer
reviewed, I mean, that\'s the analysis, isn\'t it?

DR. CRAMER: So, should we just peek at the last version of what Michael
put on just to see if those context \-- go back.

DR. DYKES: You should drop the communications is what I said.

MS. DILLEY: Yeah, and maybe emphasize the peer reviewed.

DR. HUNT: We\'re sort of capturing it because we\'re saying publicly
available.

MS. DILLEY: Right.

DR. DYKES: Right.

MS. DILLEY: Michael, I\'m not sure we have it up.

MS. ZANNONI: I would take out the future of modern biotechnology. There
is a need for objective peer reviewed.

DR. LAYTON: There is a need for.

MR. CORZINE: There\'s a need for. Wouldn\'t you want to put peer
reviewed data.

DR. LAYTON: You could say quality data.

MR. CORZINE: Okay.

MS. DILLEY: So, there is a need for publicly available \--

DR. VAN EENENNAAM: Publicly funded.

MS. DILLEY: Publicly sponsored.

DR. DYKES: Publicly sponsored.

MS. DILLEY: Publicly sponsored data collection.

DR. DYKES: Right.

MS. DILLEY: Objective peer reviewed analysis or analyses.

DR. DYKES: Of that data. Maybe you don\'t need of that data.

MS. DILLEY: On the use. I thought we were taking communications out. So,
it would be there is a need for publicly sponsored data collection,
objective peer review, I think it\'s just the end, objective peer
reviewed analyses on the use and impact of transgenic organisms period.

DR. DYKES: Period.

MS. DILLEY: Yeah. Okay. Let\'s get there and read it again and then
let\'s see if people are comfortable with that framing. There is a need
for publicly sponsored data collection and objective peer reviewed
analyses on the use and impact of transgenic organisms.

DR. CRAMER: I still like the concept of broader. Does anybody else like
it or dislike it?

UNIDENTIFIED FEMALE: Broader than what?

DR. CRAMER: If you look at, as we said before, use can be defined as how
many acres or how much, but, what we\'re really interested in is a
demonstration that has actually impacted environmental issues or
mycotoxin issues or things that are broader than just, you know, the
farmers who are planting 40 percent.

UNIDENTIFIED FEMALE: What about just making it broad?

DR. DYKES: Broad impact.

MS. DILLEY: Broad.

DR. LAYTON: It can\'t be broader unless you\'ve already got a broad.

(Discussion off the record)

MS. DILLEY: Okay. So, let\'s read it one more time. There is a need for
publicly sponsored data collection and objective peer review analyses on
the use and broad impacts of transgenic organisms.

DR. HUNT: There\'s also the availability.

DR. MELLON: We need to take the use out. We need data collection and an
objective analysis of the broad impacts. We don\'t need analysis of the
use.

MS. DILLEY: On the broad impacts of transgenic organisms?

UNIDENTIFIED FEMALE: You do on the use.

DR. MELLON: On the use?

DR. LAYTON: Yeah, I think you do.

MR. SLOCUM: One region versus another. Watersheds.

DR. LAYTON: How it fits into crop rotations and things like that.

MS. DILLEY: Josephine said a comment and because she\'s soft-spoken
nobody else heard than me. We\'ve lost the concept of availability,
accessibility, availability.

DR. HUNT: What about communication? So, I guess it\'s the analyses that
needs to be publicly available.

MS. DILLEY: It\'s objective publicly available peer reviewed?

MR. CORZINE: Maybe you need a second sentence.

DR. MELLON: Available peer reviewed analyses because objective analyses
are not really \--

MR. JAFFE: The second sentence. Such information should be made publicly
\-- such information needs to be part \--

MS. DILLEY: Okay. You guys reached a conclusion but I didn\'t hear it.

DR. MELLON: Perhaps delete objective and just have publicly available
peer-reviewed analyses.

MS. DILLEY: And publicly available peer-reviewed.

DR. DYKES: Objective and peer-reviewed should mean the same thing. It
should.

MS. DILLEY: Right.

DR. MELLON: To me, they\'re not.

MS. DILLEY: So, you\'re getting peer-reviewed, right? Okay. So, let\'s
just read it one more time. There is a need for publicly sponsored data
collection and publicly available peer-reviewed analyses on the use and
broad impact of transgenic organisms. Are we saying what we mean and we
mean what we say?

Carole, your card\'s still up. Pat, your card\'s up. Is that \--

DR. LAYTON: You covered it in the last edit. Sorry. Mine actually was
the broader, so, \--

MR. SLOCUM: I mean I\'m not so sure that publicly available\'s in the
right place. You want data to be publicly available. I mean do you want
the raw data to be publicly available too, don\'t you?

MS. DILLEY: So you want there is a need for publicly available, publicly
sponsored?

DR. HUNT: No. Carole mentioned the second sentence so let\'s do that
because then it would make sense. This data and the analyses \--

MS. DILLEY: Such data and the analyses should be publicly available? I
like that. That\'s good. Okay. So, there is a need for publicly
sponsored data collection and peer-reviewed analyses on the use and
broad impacts of transgenic organisms. Such data and the analyses should
be publicly available.

DR. LAYTON: You don\'t want to scratch and, just publicly available.
Okay?

DR. CRAMER: I still think that the concept is that there\'s a need for
more because the implication there is that there isn\'t any, which we
know there is. So, I still like the idea there is a need for more.

DR. MELLON: I support Carole.

MS. DILLEY: Mardi supports Carole. Does everybody want more?

DR. DYKES: Where are you going to put it, right there?

MS. DILLEY: Okay. So, now it reads there\'s a need for more publicly
sponsored data collection and peer reviewed analyses on the use and
broad impact of transgenic organisms. Such data and the analyses should
be publicly available. Okay. Such data and analyses should be publicly
available.

DR. DYKES: Yup. This is the topic sentence.

MS. DILLEY: Okay? Okay. So, that explanatory text should be a piece of
cake. Okay. So, that\'s good though. An hour and we\'ve got the right
topic statement.

MR. GIROUX: You said it all in the statement. Can we ever do anything
about it?

DR. LAYTON: You can just leave it as USDA has a unique role.

DR. DYKES: That was my suggestion. Just take 351 through 356.

MS. DILLEY: So, it would read, USDA has a unique role in collecting
primary data and providing \-- we deleted definitive, so, providing
information to the public.

DR. DYKES: In a fair, unbiased \--

MS. DILLEY: We had comments on that, but, you know, okay, so, I hope we
made it more clear.

DR. MELLON: I think we could delete unbiased. I mean, in a fair,
understandable, and factual way.

DR. DYKES: Right, right. And then I think we\'ve also \--

DR. LAYTON: So, we\'ve deleted unbiased?

DR. MELLON: Yes.

DR. DYKES: I thought we\'ve given some meaning here to those broad
impacts we have in the topic statement there with some of these
examples.

DR. MELLON: Good point.

DR. DYKES: I think if we just take those four or five lines I think it
hangs together \--

DR. LAYTON: And then let it go.

DR. DYKES: \-- and we don\'t get into the controversial stuff of what
the USDA\'s role is and all the other stuff.

MS. DILLEY: I\'m sorry, Michael. You wanted to take some of the
examples?

DR. DYKES: No, I say leave what we \-- in 351 through 356, mid-point, I
think we\'ve got it.

MS. DILLEY: Okay. 356, mid-point, so, ending where?

DR. DYKES: USDA also has an important role. Very last column.

MS. DILLEY: Okay.

DR. LAYTON: Leave the italics.

DR. DYKES: No. Delete it.

DR. LAYTON: No? I\'m sorry, I was thinking you were thinking
parentheses. I thought parentheses. You said italics.

DR. MELLON: What are we deleting?

DR. DYKES: The last sentence.

DR. LAYTON: We deleted the italics because it was a recommendation. It
says USDA has a unique role in collecting primary data and providing
definitive

information \--

DR. MELLON: No, definitive is out.

DR. LAYTON: Definitive is out. And providing information to the public
in a fair, understandable, and factual way. Relevant topics include not
only environmental impacts. For example, on pesticide use patterns, pest
resistant management, soil loss, et cetera, but, also social and
economic impacts, for example, on farm income, distribution of benefits,
economic opportunities, et cetera.

MS. DILLEY: Mardi?

DR. MELLON: I mean, I would \-- I don\'t \-- this is not a fall on your
sword issue, but, I actually would favor keeping it to make it clear
that there are \-- I think it makes it clearer that there is a kind of
data collection role and there\'s a peer-reviewed analysis role that
USDA isn\'t itself going to play but it\'s going to encourage.

DR. VAN EENENNAAM: You mean keeping the last sentence?

DR. MELLON: Yes, keeping the \-- I like the last sentence. And I think
it should do that. It should say here are the data, you know, all you
scientists out there.

DR. DYKES: Yeah, I\'m with Mardi. I\'d just leave it there.

MS. DILLEY: Does anybody else have a comment on that?

MR. CORZINE: Leave peer-reviewed.

DR. DYKES: It ties into the topic sentence.

DR. MELLON: Yeah, that\'s true.

DR. VAN EENENNAAM: All you did was deleted one thing.

DR. LAYTON: And then go back and take definitive out. And un-italicize
it.

MS. DILLEY: Okay. Do you need me to read it one more time or are people
clear? Russell, comment?

MR. KREMER: Just a comment. I think this is all great. I\'m happy with
the changes. But, there\'s one thing that you may think is trivial, but,
on 355 when you talk about and give examples, the first example of farm
income, this is one or two places in this document that really addresses
the number one concern of farmers and that is the profitability; is the
stuff profitable. I would like to suggest that we call it net farm
income rather than just farm income.

MS. DILLEY: So it would be add the word a net farm income?

MR. KREMER: Yes. It\'s more accurate.

MS. DILLEY: Net farm income. Okay. Okay.

DR. SCHECHTMAN: Going once, going twice.

MS. DILLEY: Okay. So, why don\'t we tackle another one. 10.5 I would
suggest would be the next one we take a look at and we start on. That
had a lot of comments. So, 10.5 on this draft is on page 13 on the
colorful document that\'s 10. And this is adventitious presence and I
know there\'s some history behind this that was also in terms of the
group\'s discussion of it in separating out 10 from 10.5; that there
were two topics and that\'s some of the background.

But, take some time to read it and reacquaint yourself with what that is
and comments and we\'ll pick that up in a couple of minutes.

DR. LAYTON: If I remember correctly the issue is we put domestic AP in
10 and international AP in 10.5. Correct?

DR. SCHECHTMAN: Yes.

MS. DILLEY: Just also a comment on the colorful document, that one edit
didn\'t come through. The first time you see a colorful, not the AP,
but, the tested, it should read origin "have tested negative," not "have
come out tested negative."

DR. SCHECHTMAN: Come out should come out.

MS. DILLEY: Come out should come out wherever you are and that should
read, "have tested negative," for a suggested edit.

Okay. Are people ready to start? Carol and then Michael.

MS. TUCKER FOREMAN: I have a threshold issue which is, I would like to
see exactly what we said on this subject in the tracing and labeling \--
traceability and labeling report. Does anybody have the document?

MS. DILLEY: No? So, do we need to maybe pick this up after lunch?

DR. LAYTON: It may be on my computer.

MS. TUCKER FOREMAN: Okay. Unless it is, because, you know, we spoke
about it at length and it would be embarrassing to say something
different.

MS. DILLEY: Different. Okay. That\'s one point. I also, Randy, probably
butchered grammatically the point you had made in here, but, you were
trying to get a concept in here and I wasn\'t sure that I addressed it
because it goes to Carol\'s point perhaps that we talked about it and
shortening it was not the way to go, but, Michael, you had your card up
and then Greg. So, go ahead.

DR. DYKES: I\'m basically fine with the two or three different versions
here I\'ve read. But, one question I have is on line 414, -15, and -16.

MS. DILLEY: Okay.

DR. DYKES: National discussions on AP issues are unlikely to
satisfactorily address these disruptions without considerations of the
perspectives of those involved in international trade. I read the
sentence and I know what it says. I don\'t see the relevance. I\'m
assuming that any discussions of the issue of AP would automatically
include the relevant stakeholders.

Unless there\'s a feeling that those involved in international trade
somehow are being excluded from these, I mean, I don\'t know what gives
rise to that. I don\'t understand.

I know what the sentence says. I just don\'t understand the significance
of it. So, my suggestion would be unless I have a better understanding
would be to delete that sentence. I don\'t think it adds anything.
Perhaps, Randy, you\'re the one that \--

MR. GIROUX: I may be able to clarify what that statement is. I think
when we wrote it we talked about the many countries individually are
looking at setting up frameworks for dealing with adventitious presence.
A section or part of each individual coming up with its own framework
for dealing with adventitious presence likely wouldn\'t solve the
international trade issues because they would all be different.

So, trying to come up with mechanisms more internationally for dealing
with AP are where the resolution lies, not in individual countries.

DR. DYKES: So I misunderstood the word national discussions. I was
thinking \-- so, what you\'re saying is, individual countries come up
with a patchwork set, you need to make sure to look at the international
perspective when you talk about it.

DR. SCHECHTMAN: The U.S. national.

MR. GIROUX: I believe that was the intent.

DR. DYKES: I agree with that statement.

MR. GIROUX: Lack of harmonization.

DR. DYKES: So, maybe we need to say something instead of national
discussions.

MS. TUCKER FOREMAN: Domestic?

DR. DYKES: Domestic. In-country domestic discussions are going to miss
the boat if they don\'t take into effect their impacts on international
trade.

DR. LAYTON: Individual country discussions?

DR. MELLON: In-country.

DR. DYKES: Yeah, something like that. I think that\'s \--

MS. DILLEY: Well, can you flip it around and be a more positive
statement like global AP mechanisms require all?

DR. DYKES: It would require countries \-- basically I think global AP is
going to require that when countries are talking about it they\'re
looking at their own domestic policies with regards to how the impact is
on international trade.

MS. DILLEY: Yeah, yeah. So, it\'s kind of a global collaboration needs
to come up with a global system basically.

DR. MELLON: Maybe we should just insert the word global.

DR. CRAMER: How about the writing? Just say discussions of AP issues
within individual countries.

DR. LAYTON: Are unlikely to satisfactorily \--

MS. DILLEY: I think Mardi had a good suggestion. Maybe it\'s global
discussions on AP issues are unlikely to satisfactorily address these
disruptions without consideration \--

SEVERAL UNIDENTIFIED SPEAKERS: No, no, no.

MS. DILLEY: All right. Okay.

DR. DYKES: I think individual country discussions on AP issues.

DR. CRAMER: So I think it reads better that, "Discussions on AP issues
within individual countries\..."

MS. DILLEY: Okay.

DR. DYKES: Yes.

DR. CRAMER: Are unlikely.

MS. DILLEY: Read it again, Carole, please.

DR. CRAMER: Discussions on AP issues within individual countries are
unlikely to satisfactorily address the disruptions.

MR. CORZINE: Do you need that unlikely to satisfactorily address these
disruptions? Could you just go on and say \-- we need one more word in
there, but, greater consideration need to require or should have
consideration of the perspectives of those involved in international
trade.

DR. SCHECHTMAN: Need to consider.

DR. DYKES: Yes, yes, I like that better, Leon.

DR. LAYTON: Okay. Say that again now.

DR. SCHECHTMAN: Need to consider.

DR. LAYTON: Need to consider.

MR. CORZINE: Or need consideration of.

DR. DYKES: To the perspectives of those involved in international trade.

MS. DILLEY: Better? Mardi?

DR. DYKES: Yes.

DR. MELLON: In the sentence that begins development of commercially
viable, I mean, maybe it would be better there to say development of a
commercially viable and certain global AP policy is a key step to
minimizing disruptions in the food and food supply chain and then we
could go on to \-- I mean, but, our objective here is a global AP
policy.

MS. DILLEY: Right. Okay. Greg.

MR. JAFFE: When I made two sort of comments about this. One was that it
was \-- it\'s very industry focused. I mean, consumers have concerns
about international AP issues as much as that and so I have some concern
that this is very focused on the food and feed chain industry impact
when I think there also are consumer impacts to adventitious presence,
but, I\'m willing to drop that concern, but, there are two parts of the
\-- that\'s one concern, but, I\'m not sure how to fix that one and
bring it in without getting this very broad issue, so, I just wanted to
state that.

But, there are two specific areas that I have additional concerns. One
is the sentence that Mardi just talked about, the development of
commercially viable AP policies is a key step. I mean, that\'s very much
a recommendation and not a sentence that I agree with. I would be more
comfortable if you took out the word commercially viable and I\'m not
convinced that they\'re a key step to minimizing disruptions. They
might.

So, I mean, I\'d be more comfortable saying development of AP policies
might minimize disruption in the food and feed supply chain. I mean, if
you have an AP policy the AP policy might say up to five percent label
it and I don\'t know if that\'s going to change what companies have to
do. I mean, AP here is not just unapproved events, but, it\'s also
approved events that are found in other places.

And, so, I think that what we\'ve learned is that there may be
contractual specifications that are different than governmental AP
specifications and those still are driving. Our consumer demands or
consumer wants are based on driving.

The AP policy of the government may be five percent, but, the public may
say, I want things that are zero percent and General Mills may still try
to give that to them. So, I\'m not convinced factually that how a
commercially viable one that makes sense commercially may still be one
that consumers are willing to accept and won\'t minimize disruption. So,
I think that sentence needs to be changed somehow.

I\'m uncomfortable with commercially viable because I\'m not sure that
addresses safety issues when we\'re talking about unapproved events.
We\'re talking about unapproved events, I\'m not sure a commercially
viable one for all type of events might in fact ensure safety so that\'s
why I\'d like those words deleted.

MS. DILLEY: So, there are a lot of nodding heads. So, the language you
suggested, I think, is what you put out there is development of \-- and,
again, if we insert global AP policies might minimize disruptions in the
food and feed supply chain.

MR. JAFFE: Right.

DR. DYKES: I think we\'ve got to characterize what that trade disruption
because I think we have to characterize \--

MS. DILLEY: So we need a qualifier on disruption?

DR. DYKES: I think so. Minimize trade disruption, I think is what we\'re
talking about.

DR. SCHECHTMAN: This would help to minimize?

DR. HUNT: This would help to minimize trade disruption?

DR. SCHECHTMAN: Might help.

MS. DILLEY: Might help.

DR. HUNT: Might help to.

MS. DILLEY: Why do that? I mean, development of global AP policies might
minimize trade disruptions in the food and feed supply chain. It might
help. I don\'t know what that adds, so, \--

MS. ZANNONI: So, are we going to ask USDA \-- or, is it that the
national policy or approach has to advance a global solution? Because
\--

MS. DILLEY: We took out national.

MS. ZANNONI: You put a global AP policy \--

MS. DILLEY: Yeah.

DR. LAYTON: Actually, that sentence needs to go after the first
sentence. I mean, after the sentence we just worked on. Development of
global AP policies should go after the sentence, discussions on AP
issues within individual countries.

MS. DILLEY: That\'s a good idea. Then I think that helps, Alison, but, I
don\'t know. If you flip those sentences would that help? I\'m sorry? I
was looking at you, Lisa. It was you who made the comment.

MS. ZANNONI: But, a global AP policy is quite different than all the
countries having their own policies but put together.

MS. DILLEY: So, should you take out global AP policies?

MS. ZANNONI: I think different countries having policies that fit toward
a global solution or a global trade policy or something.

MS. DILLEY: So, how do we say that then?

MS. ZANNONI: Harmonized.

MS. DILLEY: Harmonized AP policies? No?

MR. OLSON: I don\'t think we\'re going to get to that.

MS. ZANNONI: You think global AP policies would be easier?

MR. OLSON: You can have different policies and still function. To say
everybody\'s got to have the same policy I think is unreal.

DR. SLUTSKY: So, what\'s a global AP policy?

MR. OLSON: That\'s why there\'s policies.

DR. LAYTON: Policies.

MR. OLSON: That\'s why there\'s policies because I don\'t think they\'re
going to agree on one.

MS. DILLEY: Carol?

MS. TUCKER FOREMAN: Did we find the text from the other report because
we\'re wordsmithing something that we wordsmithed once before I think.

DR. LAYTON: I think she has.

MS. DILLEY: We\'re going to have to add because it\'s going to take \--

DR. SCHECHTMAN: Yeah, we may need a lunch break.

MS. DILLEY: Do you want to set this one aside and come back to it or are
we almost there?

DR. DYKES: I would suggest that \-- I agree with Carol. We need to make
sure that \-- obviously, we\'ve got make sure that we\'re not saying
something that\'s different. What I would suggest we try to reach some
kind of agreement on this one with the caveat that during lunch or
something we look at the other one and if we find that, hey, we\'re
saying two different things we got to come back and start over. But, if
we looked at it and think it\'s consistent \--

MR. OLSON: I think it\'s consistent, it\'s fair. I mean, the words may
be all together but I don\'t think we said anything different than we
said in the other.

DR. DYKES: But, we need to check.

DR. LAYTON: Yeah, because the authors of this were responsible for going
back to the original document and looking at it, I think.

DR. DYKES: I would advocate we finish this.

MS. DILLEY: Okay. Greg and then Mardi.

MR. JAFFE: When I was on the AP group I think generally this was
consistent with what we talked about there with the exception of the
last sentence and I would recommend that we delete the last sentence. We
did not discuss early food safety evaluations. I\'m very uncomfortable
with any kind of recommendation or suggestion that that\'s the solution
and I\'m especially uncomfortable with it when we talk about the second
part of the sentence, response about ones that are received from other
governments.

I mean, I\'m not somebody who\'s advocating that if Botswana has an
early food safety assessment and they produce one that we in the United
States should just accept that one as our evaluation for our safety of
our food.

MS. DILLEY: Does anybody have heartburn deleting that last sentence?

MR. JAFFE: Not for me.

MS. DILLEY: I don\'t hear any objection to that.

DR. DYKES: We\'re agreeable to delete.

MS. DILLEY: Okay.

DR. DYKES: It\'s adding that\'s the problem.

MS. DILLEY: It\'s adding that\'s more challenging. I know.

DR. LAYTON: The other notice we have to cite, the study, so we\'ll need
a copy from 10, the citation, I think, on this one.

MS. DILLEY: What study?

DR. LAYTON: The first, the previous, the topic, that needs to be copied
at the bottom of 10.9.

DR. DYKES: Noting that this has been done in another report?

DR. LAYTON: Noting that we have done it before.

MS. DILLEY: Oh, oh, oh, you mean in another report.

DR. LAYTON: Yeah, I\'m sorry. Other study meaning other report. Thank
you. That\'s all.

DR. SCHECHTMAN: With the same citation that we used for all of the
others.

DR. LAYTON: We\'ll just cut and paste it.

MS. DILLEY: Alison, you had a \--

DR. VAN EENENNAAM: That sentence we just wordsmithed, you should delete
it. It doesn\'t fit in there very well to me. You know, I think if you
take that out because I don\'t know what development of global AP
policies means. Actually, are we talking \-- I don\'t really know what
it means and I\'m not really sure that it adds anything. I think it
flows all right without that sentence there.

DR. LAYTON: Okay. Let\'s try it. We\'ll delete it.

MS. DILLEY: Cindy, can you read it?

MS. SULTON: Okay. I can read it. Discussions on AP issues within \-- you
want me to read the whole thing from the beginning?

MS. DILLEY: No, just that middle. Where we are is we deleted the
development of commercially viable and it starts \--

DR. SCHECHTMAN: Actually, hold on. I would say, suggest deleting it
because I know \-- I see one person shaking their head \-- shaking his
head.

DR. VAN EENNENNAAM: People know you\'re going to delete it.

MS. SULTON: Well, I\'ll put a strike through.

DR. SCHECHTMAN: Or just highlight it.

MS. SULTON: Highlight it?

DR. VAN EENENNAAM: It is highlighted. Just leave it.

MR. GIROUX: Two comments. First comment is I don\'t agree; that we
should not provide at least some guidance on the solution if we say that
currently what\'s happening is not going to work and, secondly is, I
think that we needed the sentence that says discussions \-- when we
changed the sentence above and removed the comment unlikely to
satisfactorily address the issue I think we took the essence of the
sentence out which was probably what\'s going on in the global
marketplace of individual countries developing AP policies and expecting
that they would ever fit together with each other is unlikely to be
satisfactory is an important comment and I think what we\'ve done is
taken that \-- the spirit of that out by changing the sentence the way
we did, so, I\'m not in agreement with the way that we\'ve changed that
sentence first of all.

MS. DILLEY: The discussions on AP issues.

MR. GIROUX: Right, discussions of AP issues in individual countries need
to consider the perspectives of those involved in international trade.
You\'re reading the sentence is more than that. It said \-- it said that
individual countries solving AP within those countries is unlikely to be
successful in solving the issue of international AP problem disruptions
to the food and feed supply chain, which is in the topic sentence.

I think that\'s an important point and I think we\'ve removed it so I
would want to change that sentence back again and then if we do say
that, I think we have a \-- remember, this is an advisory committee and
we should be advising the Secretary, if possible, if we can come up with
some general statement of how do we go forward I think we should make
that statement.

DR. SCHECHTMAN: Can I sort of back up on that but just make the general
question. We have two sort of conflicting things going on here. One was
a sense and some of the others of trying to remove recommendations or to
recast recommendations so they sound less like recommendations and
obviously here\'s a case where you feel strongly, Randy, that
recommendations are a good thing and I just want to sort of take the
committee\'s \--

MS. DILLEY: I\'m trying to understand which part of the recommendation,
Randy, specifically. Is it the last sentence that we had just talked
about deleting or are you talking about \--

MR. GIROUX: The sentence in red. I don\'t like the way it\'s worded,
but, if it\'s something along that line would be useful in that
paragraph.

DR. DYKES: I\'d benefit from knowing what your \-- I\'d like to hear how
you think it should read.

MS. DILLEY: I think we can fix it. I think I understand what you said
about how we changed the last one. It\'s like we talked about unlikely
and I can see where that\'s a step removed from what you\'re saying in
terms of we\'re not going to get there if countries are doing it
separately basically.

So, we need to find language that captures that because the way we\'ve
done it so far is not working. So, we need to look at that. And then
I\'m not sure on what \-- if it\'s this, that\'s the second sentence,
so, we need to kind of take those one-on-one. Do you have \--

DR. DYKES: Maybe it\'s what we \-- maybe one suggestion may be is your
point is to satisfactorily address disruptions.

MR. GIROUX: Correct.

DR. DYKES: So, maybe what we \--

MR. GIROUX: Put that back.

DR. DYKES: \-- ought to do is put that back and we say discussions on AP
issues within individual countries need to consider \--

MR. GIROUX: Let\'s put it the other place. Individual countries are
unlikely.

MR. SLOCUM: Then it\'s not a recommendation. It\'s a statement.

DR. CRAMER: How about development of AP policies within individual
countries are unlikely to satisfactorily address.

DR. DYKES: Market disruptions.

MR. GIROUX: Are unlikely. The piece that we cut which is are unlikely to
satisfactorily address the disruptions belongs after individual
countries.

DR. DYKES: Yeah.

MS. DILLEY: Okay.

MR. GIROUX: And need to be considered and considered the perspectives of
those involved in international trade.

DR. DYKES: Right.

MS. DILLEY: So, it would be \--

DR. LAYTON: In the italics words after the word countries the words you
want to put in are?

MR. GIROUX: Are unlikely to satisfactorily address these disruptions.

DR. SCHECHTMAN: So, no individual country is likely to be able to
address these disruptions even \--

DR. VAN EENENNAAM: Trade disruptions.

DR. SCHECHTMAN: Trade disruptions.

DR. VAN EENENNAAM: Is that what you want? I think it\'s trade
disruptions.

MS. DILLEY: Is it trade or market?

DR. DYKES: Trade.

MR. GIROUX: International trading issues for the food and feed supply
chain.

DR. SCHECHTMAN: Only if it\'s done \-- so what you\'re saying is that
only if it\'s done globally will these things be. Was that your point?

MR. GIROUX: No. I\'m saying that \-- what they\'re saying is no
individual country without being in discussions with other countries
considering the impacts on international trade will solve the AP issue.

MS. ZANNONI: So the solution is not unilateral.

MR. GIROUX: The solution is not a unilateral decision by a country.

DR. SCHECHTMAN: Okay, now I see.

MS. DILLEY: I\'m trying to figure out if we need two sentences or one
sentence. So now it reads, "Discussions on AP issues within individual
countries are unlikely to satisfactorily address trade disruptions
without considering the perspective of those involved in international
trade." But, I\'m not sure even if they considered them and they\'re
doing them independently if that\'s going to \-- that\'s what I don\'t
know if we\'ve got what you\'re intending, Randy, because I\'m not sure.

There are two issues. If they\'re doing it independently, which is what
perhaps they\'re doing now, that\'s not going to resolve satisfactorily.
But, even if they considered others and then still operated alone
you\'re still looking for a global AP policy, or, is it if they consider
making a step in the right direction?

DR. CRAMER: How about if instead of discussions within individual
countries we actually say development of AP policies within.

MR. CORZINE: Well, only if they\'re similar AP policies.

DR. SHURDUT: Can you just say AP policies within individual countries?

DR. CRAMER: Well, that\'s okay.

DR. SHURDUT: Just say AP policies, not even development of. Just start
off with AP policies are unlikely. Well, it says or AP policies within
individual countries or countries\' specific AP policies and then you
can scratch within individual countries.

MS. DILLEY: So, does that capture it if we do it up there?

DR. SHURDUT: Do you like that?

MS. DILLEY: Countries\' specific AP policies are unlikely to
satisfactorily address trade disruptions without considering the
perspective of those involved in international trade.

DR. SHURDUT: If they do not.

MR. OLSON: I think we lost the commercially viable way back in the
beginning and it\'s all tied to that.

MS. DILLEY: Right.

MR. OLSON: How do you make the marketplace work whether it\'s
commercially viable and take out consumers like Greg was just talking
about. It\'s commercially viable from the marketplace but we deleted
that and these sentences kind of explain that.

MS. DILLEY: So, let\'s try and break it down like we did with the
public/private research thing, or, the one we just did, not the
public/private \-- I\'m sorry.

So, we\'ve got three different concepts that we\'re trying to capture.
One is that countries are doing this on their own and that\'s
problematic and then we\'ve got the commercially viable and then we\'ve
got the consumer. There are lots of different things that are going to
work to make AP, any kind of AP policy work.

Are those the three elements that we\'re trying to weave into this text?

MR. OLSON: Pretty much.

MS. DILLEY: It\'s the market, trade and consumer pieces. Is that what
we\'re trying to do? So, we need some language. Mardi? Or, Randy, were
you \-- did you want to have another comment?

MR. GIROUX: No, I\'m good, thank you.

MS. DILLEY: Okay. I mean, I think we\'re trying to \-- we\'re
disaggregating what we need to tackle and then we need language to get
there so I think we\'re making progress. Mardi?

DR. MELLON: I mean, I would \-- I think the virtue of separating this
out and addressing the trade issue by itself is that, you know, is that
it helps \-- it\'s a way of addressing a very complex problem. I agree
wholeheartedly with everything Greg said. I just don\'t think we can
kind of address that in this \-- you know \-- in this one paragraph.

So, I would say conceptually that this one should just focus narrowly on
the issue of international trade; that there are disruptions and that
\-- in place and that there is some \-- I mean, that we need some \--
that to the extent that that is one\'s problem one needs an
international globally accepted kind of approach to solve it.

So, I mean, just conceptually I would like to say I want to have it \--
we would have other places to address the consumer concern and that\'s
why I supported Greg\'s suggested deletion of the early safety testing
which was a non-starter. But, that would be my thought is, that we ought
to think about this one very narrowly from the perspective of the
international trade community and put things in their language to
address their problems and then similarly we\'ll want to do that same
thing for others in other parts of the document.

MS. DILLEY: Okay. So here we focus on the trade and market issues on AP.
Greg?

MR. JAFFE: I mean, I just was going to say we also need to be careful
that number 10, we talk about the fact that there\'s no federal policy.
And indirectly we call for this federal policy and we did that in the
traceability and labeling report saying that, you know, there needs to
be this policy on adventitious presence federally.

I just don\'t want to put language in the next one that sort of suggests
that will not really help anything. It\'s like saying do it but then
when you do it it\'s really not going to be helpful to anybody.

MS. DILLEY: It can\'t be done individually.

DR. SCHECHTMAN: Or in a vacuum.

MS. DILLEY: Somehow we\'re just not getting there. Do you have language,
Carole? Let\'s hear it.

DR. CRAMER: Country-specific AP policies which do not encompass
considerations of international trade will not be \--

DR. LAYTON: Slow down.

DR. CRAMER: I can\'t slow down. Will not successfully address trade
issues or something like that.

MS. DILLEY: Trade disruptions. Say it again.

DR. CRAMER: Well, it sort of ties it back to commercially viable.

MS. DILLEY: Okay. But I\'m not sure we still have commercially viable in
there.

DR. CRAMER: Yeah, we put it back in.

MS. DILLEY: I don\'t know. Okay. Read it again, Carole. Just try it.
Just try it.

DR. CRAMER: Country-specific AP policies which do not encompass
considerations of international trade will not successfully address
commercial trade disruption.

UNIDENTIFIED MALE: How about are unlikely to satisfactorily address.

MS. DILLEY: Unlikely.

MS. SULTON: Unlikely to satisfactorily address what? Give me the words.

UNIDENTIFIED MALE: It\'s the last part of the sentence.

MS. SULTON: Address what?

MS. DILLEY: Address trade disruption? Eliminate disruptions. Okay. I
think it was addressed. Satisfactorily addressed, right? Okay. So, it
reads country specific AP policies which do not encompass considerations
of international trade.

MR. CORZINE: Are unlikely to satisfactorily.

MS. DILLEY: Thank you. I didn\'t know if there was another word.
Unlikely to satisfactorily \--

MR. CORZINE: Minimize.

MS. DILLEY: Is it address or minimize?

MR. CORZINE: Resolved. Or resolved. Resolve trade issues.

MS. DILLEY: Trade issues.

DR. LAYTON: Trade issues is what we have in our topic sentence.

MR. JAFFE: I think Randy\'s point is, I mean, it\'s a fine sentence.
It\'s sort of tautological. Well, obviously, if you don\'t consider it
trade then you\'re going to not address it. I think Randy\'s point is
even if you did consider trade individually in a country-specific way
you still may not avoid the trade disruption so I think \-- I mean,
again, I think it\'s a true statement, what\'s written there, because
\-- but, it\'s tautological to some extent and I think what Randy\'s
point is, is that it\'s independent of whether \-- even if that
individual country does encompass trade considerations it still may not
resolve \-- it\'s not likely to resolve.

MS. DILLEY: Is that it then? Independent country-specific AP policies
blah, blah, blah? Because if they\'re independent they\'re not knit
together basically is what you\'re saying, Greg. I mean, you\'re right
in that \--

MR. GIROUX: The first sentence is fine and, Greg, you\'ve addressed it.
That\'s the first issue. Now, the second issue is as a committee do we
make some kind of pseudo-recommendation about how you solve that
problem? And I\'d like to see that say the development of
country-specific AP policies because it suggests there are a number of
them out there and there are not.

MS. DILLEY: But, is it development of independent country-specific?

DR. LAYTON: We don\'t need the word independent on there, do you?

UNIDENTIFIED FEMALE: You don\'t need the word independent in there.

MR. GIROUX: Well, then just leave that, yes.

MS. DILLEY: So, we don\'t have independent in there, so, it\'s
development of country-specific AP policies. Okay. But, then, so, I
still don\'t understand, Randy, where you\'re looking for possible
approaches to help resolve it.

MR. GIROUX: That\'s why I\'d leave that sentence alone if everybody\'s
comfortable with that sentence, I hope. The question is what do we do
with the red sentence.

MR. CORZINE: In italics. You can scratch the red.

MS. DILLEY: Development of global AP policies might minimize trade
disruptions in the food and feed supply chain. Is anybody \--

MR. JAFFE: I\'m comfortable with that sentence.

MS. DILLEY: Okay.

MR. OLSON: I\'m still struggling with the commercially viable. You can
have it but if it doesn\'t work it doesn\'t work. I mean, you have to
have a workable policy or commercially viable policy and that\'s the
issue. You can have policies all over the place, but, they don\'t work,
that\'s the problem.

MS. TUCKER FOREMAN: Is it possible to describe commercially viable so
that it includes the consumer end of it as well as \--

MR. OLSON: Yeah. They could, yeah, probably.

MS. TUCKER FOREMAN: That may make this way too long.

MS. DILLEY: So, is it resolve trade disruptions? Ron, are you looking
for something on commercially viable in that sentence?

MR. OLSON: Well, I think the reason we got to this string of discussion
on the conference call is that we were missing this piece on
international trade and we wanted to insert it because we talked about
consumers in 10 instead of 10.5. So, 10.5, the instructions were to take
out this context of international trade.

MS. DILLEY: Okay.

MR. OLSON: And, so, that\'s kind of the theme it was written on in the
first place. When you get into workability and it\'s viable and \--

MS. DILLEY: Okay.

MR. OLSON: \-- the market functions.

MS. DILLEY: So, let\'s try and figure out language for a commercially
viable, either defining it, or, alternate language. Alison?

DR. VAN EENENNAAM: Can I ask why we deleted the sentence that had
commercially viable? It used to be above that italics sentence and \--

MR. JAFFE: We just moved it.

MR. OLSON: We deleted it, not added it back in.

MS. DILLEY: It sounds like either we need different language to be more
specific or we need to define commercially viable, what is meant by
that.

DR. DYKES: I\'m fine with commercially viable or some other words that
communicate what we\'re trying to say there.

DR. SCHECHTMAN: Can I ask a question about the heartburn regarding
commercially viable that I\'ve heard some folks? Is it commercially \--
is it \-- is this about commercially viable policies or commercially
viable approaches?

MR. JAFFE: My issue is that, I mean, I\'m comfortable with the word
commercially viable because we\'re talking about \-- I don\'t think
commercially viable works when you\'re talking about a safety issue.
We\'re not talking about a safety issue, I don\'t have a problem with
that.

But, we\'re talking here about both approved events and unapproved
events and so for approved events I don\'t have a problem with
commercially viable because then it\'s not really a regulatory safety
issue. It\'s an issue of market workings and I put labeling in that
commercially \-- you know, it\'s after something\'s been approved.

But, we\'re talking here about also unapproved events and the science
out there says that some basic allergens at very low levels and I\'m not
real comfortable with commercially viable which might be 5 percent or 3
percent. I\'m very comfortable with when it\'s approved and the issue is
labeling and traceability and other kinds of things, but, I\'m not
comfortable with it in the unapproved context.

And I don\'t think that safety standards should be driven by commercial
viability.

DR. LAYTON: So, if you put for approved events in that sentence and
commercially viable you\'re okay?

MR. JAFFE: But, AP is involving both of those.

DR. LAYTON: Okay.

MR. JAFFE: I mean, the AP international is involving both of them so
that\'s why I\'m comfortable with global AP policies. I think that\'s
advantageous to get. I don\'t want harmonization down to \-- I don\'t
want to accept any country\'s thing. I understand the need for moving
towards global standards that meet with everybody\'s needs here. I
don\'t have a problem with that, but, I don\'t \-- I don\'t want them to
be driven by commercial viability as the sole or the main driver for
that policy.

MS. DILLEY: Randy?

MR. GIROUX: So, I don\'t agree that they would be because if an
individual country determined that they\'re unapproved and from a
commercial perspective we deliver them, so, I\'m not sure I understand
where you\'re coming from, Greg, when you say I don\'t want a
commercially viable \-- I don\'t want commercially viable to be the
decision for the safety of an event.

I\'m not sure that\'s what we\'re saying here. I think that whatever the
solutions are that whatever the national solutions are for AP that they
have to be commercially viable. If they say it\'s zero tolerance then
that\'s not commercially viable. And that exists today. We all know it
is not commercially viable. And, so, but, if a country makes that
decision, if individual countries can make a decision to have a policy
that is not commercially viable \--

MS. DILLEY: Bernice?

DR. SLUTSKY: I think what Greg is saying and it\'s reflected in, you
know, what we laid out in that OSTP document is that when you\'re
talking about events that haven\'t gone through a regulatory process,
whether it\'s here, whether it\'s, you know, whether it\'s anywhere
it\'s not possible to set across the board, for example, a threshold
because of issues like allergens where you cannot determine an absolute
level under which, you know, an allergen is safe, a potential allergen
is safe.

And that\'s why the U.S. Government took the approach of doing it on a
protein-by-protein basis and, so, I think that\'s, you know, the basic
concern when you\'re talking about unapproved events and, so \--

MS. DILLEY: You\'re not disagreeing. We need to find language that
clarifies what you\'re saying.

DR. DYKES: We need to modify AP policies to say that the AP policies
have to ensure or assure food, feed, and environmental safety.

MR. GIROUX: I think that I understand that issue and I think it became
very relevant, the issue of unapproved everywhere became very relevant
in Japan and so for that case I believe that\'s why I crafted this
additional language that talked about there\'s two buckets here.
There\'s things that have never been approved anywhere and a food safety
assessment may be the solution to it, but, there is a more pressing need
around events that have completed regulatory approval process that we
set some commercial tolerances around those types of products.

And that\'s what was clear in the language that we haven\'t discussed
but it\'s in the document.

DR. SHURDUT: And it sounds like that is consistent with what Greg\'s
talking about.

MR. GIROUX: Exactly.

MS. DILLEY: Right.

DR. SHURDUT: I do think we need to make that distinction because that\'s
where we trip up, experimental events versus approved events.

MR. GIROUX: Always.

MR. JAFFE: I\'m not necessarily talking about experimental events. I\'m
talking about events that have been approved somewhere but haven\'t been
approved in ours and I\'m not \-- I\'m not comfortable with saying that
if it\'s been approved in Botswana that we should take their approval
and have an adventitious, commercially viable adventitious level for
that.

That\'s just \-- that is sort of harmonization down to the potentially
lowest \-- and I don\'t mean to pick on Botswana, but, you know, I want
our sovereignty to make our own decisions about whether something is
safe for our \-- for the U.S. I want FDA or somebody to make that
specific decision. I don\'t want to rely on China or Botswana or
somebody else\'s determination that that\'s safe for their people. They
have different safety standards.

So, I do \-- that was one of my problems with that statement.

MS. TUCKER FOREMAN: Randy, how did you all say it in the labeling \--
I\'m sorry I keep coming back to this, but, we\'re trying to wordsmith
something where I think we\'ve been through this process before. Did we
not address it?

MR. GIROUX: I don\'t agree, Carol. What we did in the traceability and
labeling document is, we did lay out the different types of AP. We did
talk about what are the different types. When we started talking about
how we were going to deal with AP internationally we never \-- we
defined it but we didn\'t do anything \-- we didn\'t say anything about
it. It was just a here are the facts and we didn\'t \-- it isn\'t the
same as what we\'re doing here. That\'s the facts. Now we\'re trying to
get the issue which is different.

And, you know, this is clearly evident that when we talk about AP, if
the discussion is about safety, it\'s derailed. If there a lot of events
in the marketplace that have four, five, six, seven national safety
assessments and that piece of the AP is more of a commercial issue than
the events that have never been approved everywhere. And, so, the
challenge, the question is, can we separate those two. Is it possible to
separate those two and talk about ones that are not safety issues and
however you want to define that.

MS. TUCKER FOREMAN: I know we\'ve talked about the problem with
autonomous national decisions, but, are we prepared to say it\'s been
through the regulatory process in the United States. It\'s okay with us
if it\'s autonomous.

MR. GIROUX: It\'s a whole other debate and I don\'t think we should get
into here.

MS. DILLEY: Right. So, would it be possible \-- I think \-- I mean,
we\'ve done some work to disaggregate what the different issues are that
we kind of lumped together here and I think that\'s been the cause of
the \-- one of the \-- I mean, we may just disagree, but, I think we\'ve
got a ways to understanding what issues we\'re actually trying to tackle
and communicate here.

I think it would be best served to go to a couple of people to take a
crack at some language because drafting in committee has been a little
challenging. And we\'re also at that lunch \-- at the appointed lunch
hour. So, I don\'t know if, like you and Greg would take 15 minutes to
take a crack at some language.

MR. GIROUX: We\'re struggling over the word commercially viable and
that\'s all we\'re struggling on this entire paragraph so I don\'t want
us to go have an entire re-craft of this and we\'re only struggling with
two words.

DR. SCHECHTMAN: I think there\'s also an issue on the last sentence, if
I heard Greg right, that goes to issues of national sovereignty.

MR. JAFFE: That sentence is deleted. I don\'t know, are you proposing
that it goes back in? I don\'t think anyone\'s proposing that it go back
in.

DR. SCHECHTMAN: No, I thought that Greg \--

MR. JAFFE: It\'s gone.

DR. LAYTON: International acceptance is gone, that sentence.

DR. DYKES: The last sentence in the paragraph is gone. 423 through the
end of the thing is gone.

DR. LAYTON: The last sentence of the whole system now is situations in
which.

DR. SCHECHTMAN: Okay. I think that sentence is gone, but, I think
another of Randy\'s comments was accommodated in the last sentence of
the colorful draft which is what you were speaking about before, Randy,
if I can \--

MS. ZANNONI: You mean the one in parens?

DR. SCHECHTMAN: Yes, the one that\'s in fancy brackets.

MR. GIROUX: Fancy brackets. And I\'m willing to drop that.

MS. DILLEY: If we can resolve commercially viable piece.

MR. GIROUX: I mean, that just says commercially viable.

MS. DILLEY: Okay. So, we still need to \--

DR. DYKES: The one in red.

MS. SULTON: You want the one in red? Okay.

MR. GIROUX: I don\'t want one in red.

MS. DILLEY: You don\'t want the one in red?

MR. GIROUX: No, I\'m okay with commercially viable.

MS. DILLEY: Development of global commercially viable AP policies might
minimize trade disruptions in the food and feed supply chain. But,
that\'s still problematic, right, if I understood?

DR. SHURDUT: It depends on the interpretation. It\'s not necessarily
exclusive, the one word. It can be commercially viable and meet this
threshold.

DR. DYKES: Is there another word or something other than commercially
viable that would satisfy you, Greg?

MS. DILLEY: Well, I\'m turning to Ron because I think \--

MR. JAFFE: I mean, and I would want to add something in the sentence
that also said, development of just global and commercially viable AP
policies that also ensure safety might minimize trade disruptions.

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

MS. DILLEY: Okay.

UNIDENTIFIED MALE: I think we all agree with that.

DR. DYKES: So, finish your statement. Food, feed, safety.

MS. DILLEY: That also ensures \-- say it again. That ensures \--

MR. JAFFE: Safety.

MS. DILLEY: That ensures safety.

MR. JAFFE: You\'ve got to put food, feed, and environmental safety,
whichever.

DR. DYKES: Food, feed, and environmental is what we\'re using in a
number of places.

MS. DILLEY: Okay. So, development of global \--

MS. SULTON: Global commercially viable AP policies that also ensure
food, feed, and environmental safety might minimize trade disruptions in
the food and feed supply chain.

DR. SLUTSKY: We\'ll do that next week.

MS. DILLEY: Okay. Does that get us closer to \--okay, so, maybe we
don\'t need additional work on it. Let\'s just make sure because it
would be great to knock this one out if we can before lunch.

So, now it reads, the whole thing. Okay. So, you want to hear the whole
thing?

MR. GRANT: Before you do, Abby, it\'s just a minor change in there, but
we talked about grain and grain products and that needs to be food and
feed products. Grain and grain products is too narrow.

MR. GIROUX: Yeah, agreed.

MS. SULTON: Food and feed products?

MR. GRANT: Food and feed.

MS. DILLEY: Okay. So, let\'s take a run at this again.

MS. SULTON: From the top?

MS. DILLEY: From the top. Cindy, do you want to read it?

MS. SULTON: Okay. Adventitious presence of transgenic varieties in
commodities for food or feed use can occur with transgenic events not
yet approved in export markets, events unapproved in all markets, or,
events present in conventionally sourced specialty programs. The
development of country-specific AP policies that do not encompass
considerations of international trade is unlikely to satisfactorily
resolve trade issues. Development of globally commercial \-- global
commercially viable AP policies that also ensure food, feed, and
environmental safety might minimize trade disruptions in the food and
feed supply chain.

The adoption of different approaches to AP by different countries
hinders the flow of food and feed products and exposes trade to shipment
rejections and substantial costs. Situations in which no adventitious
presence of a particular transgenic event is allowed to carry the risk
and even after multiple tests at origin have come out negative a
substantial positive \-- a subsequent positive test at destination may
place a shipment out of compliance.

DR. SCHECHTMAN: Take out that to you had added.

MR. GRANT: It will come out negative. It tested negative.

MS. DILLEY: Go ahead. Tested negative, yeah.

DR. HUNT: I have a comment regarding the sentence beginning, the
adoption of the approaches to AP. Haven\'t we just said that two
sentences above? And, therefore, we could just strike that sentence out.

MS. DILLEY: Redundant sentence, yeah.

DR. HUNT: The adoption rejection. We talk about trade disputes.

DR. CRAMER: No, I think we ought to leave it.

MS. DILLEY: You want to leave it. Mardi?

DR. HUNT: But, don\'t we say that?

MS. DILLEY: It\'s redundant, part of it, but, in terms of the
continuation of that sentence, it\'s a new concept, I think. Right now
we\'re keeping it. Mardi, did you have a comment?

DR. MELLON: I just want to go back to Michael\'s point about whether
we\'re going to have recommendations or not. If there\'s ever an issue
that cried out for a recommendation it\'s this one. We have never in
this country had an open public discussion of all the ramifications of
an adventitious presence policy. I mean, all the discussions are taking
place in various little unconnected venues, often in the trade
environment.

But, it seems to me that one of the problems that we have here is that
there has been no \-- you know \-- there has been no discussion where
all the issues have been brought together, particularly at a place where
the consumer interests have had an opportunity to express, you know,
their views about what adventitious policy, present policy ought to be.

So, I would at least like to put on the table that this is one issue on
which we might consider a recommendation along the lines that the USDA
sponsor a conversation about adventitious policy that includes all the
stakeholders.

MS. DILLEY: Can we put it on the table and then come back after lunch?

DR. MELLON: Yes, yes. I do it reluctantly.

MS. DILLEY: There are two things. I mean, one is setting the precedent
of taking a run at recommendation language because I think that at the
last meeting or the last \-- it\'s hard, but, you put it on the table
and I acknowledge that and, so, can we pick that back up after lunch
because it\'s ten after twelve right now and I don\'t want to cut you
short of your lunchtime break.

So, why don\'t we leave this up here for now and we\'ll come back and
make a check of this when we come back because we\'ve got to put it to
bed but I think we\'ve made a lot of progress in getting there. And do
we have any particulars on lunch. There\'s the cafeteria downstairs.

DR. SCHECHTMAN: The cafeteria downstairs is the easiest. If people want
to go over across the way we can escort people over but it\'s probably
easiest just to go downstairs.

DR. LAYTON: And what time are we going to be back?

MS. DILLEY: 1:15.

(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}

MS. DILLEY: When we left off, Mardi raised the issue of perhaps we want
to attempt recommendation language from this and her and I talked
briefly and I don\'t know if this is an acceptable way to address it
from the committee\'s point of view, but, again, to look at
recommendation language is maybe the sprinkles on the icing on the cake
and so if we can maybe go through the cake first and then \-- I\'m not
sure what the icing is \-- and then \--

DR. LAYTON: Introduction.

MS. DILLEY: Introduction. And then \-- but, basically the concept would
be to table that conversation at this point. We need to get through
understandable topics and the explanatory language first and then come
back to \-- having done that, are there any topics that we want to take
a run at recommendation language and then see if we can get to that
point and take it on at that point.

So, it\'s really setting it aside right now and get through the rest of
the text before we come back to that topic.

DR. SCHECHTMAN: And if I can add. If there\'s anything in there that
sneaks through as a recommendation and no one thinks is a
recommendation.

MS. DILLEY: I mean, we\'re still trying to eliminate recommendation
language \-- reformulate recommendation language as we said at the
beginning so we\'ll be going through the rest of the text to do that and
then ask the question is there any additional thing we want to say.
Randy?

MR. GIROUX: You were just saying knowing that we are going to run out of
time \--

MS. DILLEY: Right.

MR. GIROUX: \-- and knowing that this is such an important topic I think
to everybody here at the table, I\'d be more comfortable if we would
take at least a quick run at a recommendation \-- a non-recommendation.
I support Mardi in that.

MS. DILLEY: A non-recommendation?

MR. GIROUX: Well, whatever you want to call it. That if we make a
recommendation that we should do it now while it\'s fresh, while most of
what people have said is already still in their minds post-lunch, and if
we get hung up maybe think twice about it, but, \--

MS. DILLEY: Can we put a time limit on maybe?

DR. LAYTON: Maybe ten minutes.

MR. GIROUX: We may be able to come up with something pretty quick. In
fact, I like what Mardi recommended, I think, at the beginning if she\'d
just reiterate it.

DR. LAYTON: Michael?

DR. DYKES: I\'m kind of there too. I\'m with Randy on that. We know how
this process works. We get down too far and we won\'t get there. I think
adventitious presence is an absolute important issue. We spent a lot of
time talking about it on the T&L report. We\'ve got 10 and 10.5 here on
the topic. I would think \-- I\'m where Mardi is. I think we should have
something in there that acknowledges from this group that this is
something that needs to be worked on.

MS. DILLEY: Carol?

MS. TUCKER FOREMAN: Oh, I\'d use basically the same facts to argue the
other way. The adventitious presence, we\'ve got a whole report on it.
There are issues here where we have some substantial disagreement and we
haven\'t spent any time on them and I would like to get through the
basic work on these other issues and then come back and think about
other recommendations.

MS. DILLEY: Okay. Would you object, Carol, to spending like ten minutes
on this and then stop or do a time limit, or, you just don\'t want to go
into recommendations period?

MS. TUCKER FOREMAN: You know what, it\'s okay if we spend ten minutes on
it.

MS. DILLEY: Okay.

MS. TUCKER FOREMAN: I\'m going to have a hard time with anything that is
specifically a recommendation because all the way through we\'ve said we
weren\'t going to have recommendations and we\'ve taken recommendation
language out of a lot of other issues. If you open this box we\'re going
to be looking at recommendation language on other issues. This one\'s
not that different.

MS. DILLEY: Okay.

DR. SCHECHTMAN: Can I make one?

MS. DILLEY: Yes.

DR. SCHECHTMAN: I mean, one thing may be the context to think about it
is that there is some sense to think about once you have one
recommendation, if that\'s the only one that has a recommendation on it
\-- I think once you start doing recommendations you need to think about
the whole set of recommendations that you\'re making to see \-- if
there\'s only one issue with the recommendation it assumes \--

MS. DILLEY: That that\'s a message of the report.

DR. SCHECHTMAN: That\'s right. That that\'s the message of the report,
so, I think there is, even if we work on it now, there would need to be
a time afterwards where you\'d have to think about all the
recommendations together.

MS. DILLEY: Pat and then Randy.

DR. LAYTON: I guess, and this is something that we sort of \-- Margaret,
who I ate lunch with, mentioned. I think that coexistence comes up next.

MR. JAFFE: No.

DR. SCHECHTMAN: You mean as the next topic?

DR. LAYTON: As the next topic after this report is done.

DR. SCHECHTMAN: That\'s one of the two.

DR. LAYTON: One of the two.

MS. DILLEY: Okay. So, finish your thought.

DR. LAYTON: And maybe if that were the case that may be where we could
actually have a fuller discussion and more time if that isn\'t part of
the issue. I just throw that out. I don\'t remember what we said at
lunch. It\'s not general, but, anyway.

MR. GIROUX: So, I disagree that every topic has to have a
recommendation. I think there are some that deserve recommendations and
some that don\'t. There very likely will be some that Carol would like
to make a recommendation for and I don\'t think we should throw that off
the table if we think a recommendation is of value to the Secretary.

I think if we can\'t come to an agreement very quickly on what the
recommendation would be on any topic then there shouldn\'t be a
recommendation. But, if we can come to consensus on one, two, five of
the topics for what the recommendation should be I don\'t think we
should throw it out.

MS. TUCKER FOREMAN: I\'m sorry. The agreement was we would go forward
and we would not make recommendations. That was how we wrote these and
where recommendations creep into the language we\'ve tried to get them
reworded so that they\'re not recommendations and if you open this up to
making a recommendation we\'re going to have a discussion about
recommendations on all of them, Randy.

I don\'t think we have the time to do that.

MS. DILLEY: Why don\'t we do this. One is, Mardi, I don\'t know if you
wrote down anything because what I\'ve heard in terms of an argument for
recommendations is I\'m kind of on the same wave length with Mardi, and
I don\'t know if that was the wave length of making recommendations or
making a particular recommendation that you were making for language on
this one.

If you can just repeat that and we table the discussion on
recommendations to come back because I do think there are a lot of
different things in terms of going down the path of recommendations of
when we end up, if we only have two recommendations then those are the
two things that people are going to look at and I don\'t know if that\'s
what you want the group to do or whatever.

So, I\'m free associating. I don\'t know what I\'m doing, but, why
don\'t we just \-- I would like Mardi, if you have that language, to
repeat it and then if there are any other comments in terms of it\'s in
the ballpark or it\'s not and then we just move on to 14. That\'s what
we said we would pick up and we come back. We definitely come back to
the issue of recommendations more global when we\'ve gone through a few
more topics.

DR. LAYTON: Let\'s not put it on the computer.

MS. DILLEY: No.

DR. LAYTON: Let\'s write it down but not put it on the computer, Cindy.

MS. DILLEY: That\'s fine.

MS. SULTON: Fine.

MS. DILLEY: Did you have language because I\'m not sure if you did?

DR. MELLON: It\'s a one sentence recommendation.

MS. DILLEY: Okay. Let\'s have it.

DR. MELLON: The USDA sponsor a national conversation on the implications
of adventitious presence and that they invite to that conversation all
the stakeholders.

DR. LAYTON: Okay. The USDA sponsor a?

DR. MELLON: But, the essence is that they have an open public
conversation about the issues associated with adventitious presence and
that they invite all of the stakeholders to that conversation.

DR. LAYTON: Sponsor a conversation on AP including all stakeholders.

DR. MELLON: But, having said that, I do agree with Carol that we if
leave that \-- you know \-- we got to kind of decide whether we\'re
going to be on the recommendation side of the fence or
non-recommendation side of the fence and it seems to me that for the
time being it\'s probably better to be on the non-recommendation side of
the fence.

DR. LAYTON: Can I ask a question? On this 10, is about domestic AP. This
is about international trade. Is that the same thing on both?

DR. MELLON: It\'s a conversation that included everybody. It includes
the people who care about it from all points of view, I mean, domestic
and international. They\'d all be at the table.

MS. DILLEY: Ron and then Jo.

MR. OLSON: This is just a softer way of saying it perhaps but instead of
saying you need an open forum or something like that you could just say
something like this is an important or complicated issue requiring input
from a broad base of stakeholders or something like that rather than
saying you\'ve got to hold a meeting and do it this way. You send a
message that input is needed from everybody on this issue because it\'s
very important.

MS. TUCKER FOREMAN: And that\'s consistent with the way we handled the
other issues.

DR. DYKES: Then it\'s not a recommendation.

MS. DILLEY: Okay.

MR. OLSON: Yeah, but, then you can \--

DR. VAN EENENNAAM: You\'ll be able to capture the essence, I think, of
what Mardi said with a different kind of language. Let\'s look at the
message you\'re trying to send.

MS. DILLEY: Right. The concept in there. Okay.

DR. DYKES: That allows them to stay within the guidelines of no
recommendations.

MS. TUCKER FOREMAN: And we\'ve got it in a couple of these already where
there\'s language that clearly sends \--

MS. DILLEY: Okay. So we do want to add it to 10.5?

MS. TUCKER FOREMAN: Yes.

MS. DILLEY: Okay.

DR. SCHECHTMAN: We successfully turned it into a non-recommendation.

MR. CORZINE: Can we get that captured? What did you say, Ron?

MR. OLSON: It\'s either like an important or complicated issue requiring
input from a broad base of stakeholders.

DR. LAYTON: This is an important issue requiring an input from a broad
base of stakeholders.

MR. OLSON: Something like that.

(Discussion off the record)

MS. DILLEY: This is an important and complicated issue requiring input
from a broad range of stakeholders. Is that the \-- okay. Greg?

MR. JAFFE: My question is, assuming we agree with that language, is it
going in 10.5 or 10?

DR. LAYTON: It may go in both.

DR. MELLON: I would say it just be a general recommendation at the end
of the whole thing. I don\'t think we need to associate it with a
particular \-- you mean if it doesn\'t \--

MR. JAFFE: I don\'t think we\'re agreeing to have a separate section
that has recommendations.

MS. DILLEY: No, no, no, right. We haven\'t done 10 yet.

MR. JAFFE: You\'re talking about putting a sentence in there like in a
discussion. It\'s supposed to go to a specific place.

DR. MELLON: I\'d put it in the domestic one.

MR. JAFFE: Okay. If it\'s not being put there and I think it has a very
different meaning depending on whether it\'s international or domestic
and I\'m more comfortable with that language in the domestic one, 10,
than 10.5 because you\'re talking about a broad range of stakeholders in
10.5 when 10.5 is really talking about feed and exports and trade. That
broad range of stakeholders may not include the same group of
stakeholders as 10.

MS. DILLEY: So, is it both or is one or the other?

MR. JAFFE: I don\'t think it goes in both.

DR. DYKES: How about we put it in 10.5 and we hold it when we come back
to 10 we determine if it best suits in 10 or 10.5 or both. How about
that.

MS. DILLEY: When we come back to 10. Okay.

DR. DYKES: We agreed to the sentence. We\'re just now debating about
where to put it.

MS. DILLEY: Where to put it.

DR. LAYTON: Okay. Can we move to 14?

MR. JAFFE: Well, I guess if it\'s put in 10 I\'m comfortable with it. If
it\'s put in 10.5, 10.5 isn't really talking about consumers and other
kinds of NGO\'s. It\'s talking about impact on trade disruption and feed
and food chain and I would read a broad range of stakeholders to mean
the people in that narrow group of people that trade disruptions are
relating to, not necessarily the consumer on the street, so, I think it
has a different meaning.

I\'m not as comfortable with it in \--

MS. ZANNONI: In 10.5 they should be talking to other governments.

MR. JAFFE: Right. A broad range of stakeholders is different things.
It\'s a different discussion.

MS. ZANNONI: Exactly.

MR. JAFFE: And the one that Mardi\'s talking about is really to sort of
set forth the U.S. AP policy, not to talk about just trade disruptions
and how to minimize those. It\'s what 10.5 is talking about.

DR. MELLON: I agree. It\'s better in 10 for the time being.

MS. DILLEY: If the language you just came up with went to 10 \--

MR. JAFFE: Then I\'m more comfortable with it.

MS. DILLEY: But, I also think that Randy\'s point is that it kind of
carries \-- it goes to the next step potentially, logically, from if all
these countries are having different conversations and that\'s not going
to satisfactorily address it then you \-- the next step is to say you
should really promote, not harmonization, we\'re not using that term,
but, the discussion of an AP policy globally and have the various
stakeholders, i.e., governments, I guess, at the table.

Is that what you\'re \--

MR. GIROUX: That\'s correct. I was not suggesting a recommendation for
10. I was suggesting a recommendation for 10.5 and I think we crafted it
under 10.5 so I\'m not comfortable all of a sudden taking that
recommendation and craft it for 10.5 and sticking it on 10.

Now, if broad range of stakeholders isn\'t the correct word, maybe it
should say appropriate stakeholders. Would that make you feel more
comfortable? Because you\'re right, it\'s not everybody in the
international market, but, it is something, a stakeholder discussion
that has to occur. Maybe appropriate is a better word.

MS. DILLEY: No, I think it\'s stakeholders it\'s more about.

MR. OLSON: Maybe broad isn\'t the right word. I don\'t know.

MS. DILLEY: It\'s confusing.

DR. MELLON: Or just use appropriate, put it in. I like broad in 10.

DR. SCHECHTMAN: A suggestion that may or may not do anything here. What
if you were to say in 10.5 this is an important complex issue linked to
issue number 10 which requires a \--

DR. DYKES: Why don\'t you put it in 10 and then 10.5 say as in \--

DR. LAYTON: The previous issue.

DR. DYKES: This is an important issue and say it twice and then be done
with it.

MR. JAFFE: I guess I would add all interested stakeholders.

MS. DILLEY: Okay. In 10.5?

MR. JAFFE: Yes.

DR. LAYTON: And then you\'d be leaving it as is?

MR. JAFFE: I mean, yeah. I want the stakeholders to self-select them as
opposed to somebody else selecting who the stakeholders are.

MS. TUCKER FOREMAN: Can we use the same language in 10 as in 10.5?

MS. DILLEY: Yes.

DR. DYKES: I think that\'s the simplest.

MS. TUCKER FOREMAN: It\'s the same language in 10 as in 10.5. That\'s
fine by me.

MS. DILLEY: Say interested stakeholders as the qualifier?

MR. JAFFE: Right.

MS. DILLEY: Okay. We\'re done. Move on.

DR. DYKES: Stick it in 10 as well.

DR. CRAMER: It would have to be.

MS. DILLEY: We\'ll fix 10. We\'re going to get to 10. I didn\'t think it
was as challenging as some of the other ones. 14. We can make it a
challenge. All right. So, 14. Do you want a minute to read and
reacquaint yourself with the comments?

On the text, version for editing at the January plenary it\'s on page
15, template 14. On the colored document it\'s page 11.

So, in 14 there are a mix of comments and one is terminology which I
think is a helpful point to be made in terms of we, in our previous
topic, used specialty products that refer to specialty crops and it
started getting confusing so there was a suggestion, I think it was
Carol who suggested maybe being specific to medical and industrial
products because that\'s what we were talking about in here.

But, that\'s up to the committee in terms of whether that is the right
terminology you want to use. Then there\'s also \-- this is not just
some members think and others think, but, there\'s also still others in
terms of taking a different cut of the issue so different perspectives
on it and that\'s what\'s been highlighted in alternative text. But, you
can take these issues one at a time and working off the text that was
the original language on page 15 of the version for editing at the
January plenary.

But, those are some of the things that struck me as comments that needed
to work through.

MR. GRANT: Abby, I guess just to start, I liked the insertion of the
word "food" in the colorful draft where in the first sentence of the
issue statement and I think that\'s critical that the word "food" be in
there. The regulatory system for genetically engineered food crops that
produce non-food products. I think that\'s important that that be there.

I don\'t like the word contamination used farther down. I think the
issue is the adventitious presence, not necessarily contamination.

MS. DILLEY: Okay. Where\'s that?

DR. LAYTON: Last sentence in the bold, others accept that contamination.
You would say others accept that adventitious presence may occur?

MR. GRANT: Yes. Or inadvertent presence or something like that.
Adventitious presence probably would be the word I would use.

MS. DILLEY: Okay. So, Alison and then Carole Cramer.

DR. VAN EENENNAAM: Just the topic sentence. I think the first time
we\'ve had, "Some members this and some members that" in the actual
topic sentence. I\'m not sure that should be in the topic sentence or
the first paragraph of the discussion.

DR. CRAMER: I agree with that. That\'s actually part of why my card was
up. I think we ought to just have the first sentence of the topic
sentence, some members and then step down into the text. The other thing
is I don\'t necessarily think we should put food crops because are we
asking the regulatory system to develop distinct regulations for if
it\'s a food versus a non-food crop? I mean, it\'s just the regulatory
system for genetically engineered crops that have come in. It\'s a
single regulatory system.

But, what we\'re then saying is that it ensures the safety of the food
feed systems. Well, I guess I don\'t like the insertion of feed.

MS. DILLEY: Greg?

MR. JAFFE: Well, I guess I\'m of the view that I like the topic, the
heading, the head sentence the way they were with the three sentences. I
think the first sentence really doesn\'t capture the point, a summary of
what the discussion is below and the discussion below is that some
members have different opinions on this topic.

The first sentence alone, for me, is too generic and it doesn\'t convey
the topic.

MS. DILLEY: Okay. So, basically you\'re addressing the issue of whether
you continue with the bold as part of the topic statement that\'s on
some others, still others?

MR. JAFFE: Yes.

MS. DILLEY: Okay. Carol?

MS. TUCKER FOREMAN: Yeah, I agree with Greg on the first issue. It\'s
okay with me to not have food in that first sentence, but, the real
issue here is having these things show up in food crops so somehow we
have to have in that system \-- in that sentence a reference in fact. I
don\'t care if these things end up in tobacco and flax and all sorts of
other things. It\'s if they end up in somebody\'s breakfast cereal that
it makes a difference.

And I think that\'s an important point.

DR. CRAMER: So you don\'t think that the last statement which is going
to ensure the integrity of the food feed system covers that?

MS. TUCKER FOREMAN: No, I don\'t. I think that the real issue is food
crops and I think it\'s worth emphasizing that that is an issue.

DR. SCHECHTMAN: Can I ask one question about that? The specific
reference that you want is contained in text below. Is that \--

MS. TUCKER FOREMAN: You know, I\'m the one who put the word in. I\'m the
one who thinks that it belongs in the bold face type because that\'s why
the food processors and the grocery manufacturers both filed comments
that really said that USDA\'s proposed regulations were quite inadequate
to deal with this issue; that they\'re concerned. That\'s the one we
ought to deal with.

MS. DILLEY: So, other comments on the \-- is it the food crops that
we\'re really trying to highlight or is it keeping \-- is it the broader
issue of variety of different crops?

MS. TUCKER FOREMAN: Abby, I have one \-- I\'m sorry, a third thing which
was, well, we can have a word other than contamination, but,
adventitious presence is \-- it\'s a hard one for me there because I
think this is a different category of issue. Whether it is technically
and scientifically it is clearly a different category with regard to the
public\'s response.

MS. DILLEY: Randy?

MS. TUCKER FOREMAN: I\'ll open the computer and see if I can find a
category.

MS. DILLEY: Randy?

MR. GIROUX: I hear what you\'re saying, Carol, but, I wouldn\'t agree
that it is only the food industry that\'s concerned with presence of
pharma industrial crops in their particular products. The same would
apply to the feed industry, I believe it would be fair to say. As well,
it may apply to the tobacco industry who wouldn\'t want people smoking
pharma crops.

So, I\'m having a little struggle calling it food specifically.

MS. DILLEY: Okay.

MR. GIROUX: And I would want to see consistent regulations across all of
the classes of that particular crop.

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

MS. DILLEY: So, to ensure the integrity of the food-feed system it\'s
really broader than that. I don\'t know if you can pick up your point on
the food crops or a particular issue below in explanatory text or maybe
be able to do that because it is broader the way we\'re talking about
it, I think.

MS. TUCKER FOREMAN: I will accept \-- I\'ll accept that. I think that is
\--

MR. GRANT: I\'m not sure I will, but, I\'ll listen for a while and see.
I do think there is an issue that is especially relevant to potential,
and I\'ll use the word contamination in food. I think that\'s a real
issue. And I will grant you that an appropriate regulatory system that
ensures integrity of the food-feed system, that should capture it, but,
this is larger than just simply \-- in my mind, this is larger than just
simply an adequate regulatory system.

And, so, I\'ll accept that there may be a different way to word it and
to draw that distinction as we work through this, but, just place that
marker.

MS. DILLEY: I guess the issue is if you were to remove it from the top
sentence just for now, and we need to work through it and appreciate
your seeing if we can satisfactorily address it in the explanatory text,
we pick that concept back up in the explanatory text saying a major
concern regarding the use of food crops to produce medical and
industrial products is that the food crops in which they are grown are
the products derived from them although never intended for food or feed
use.

Well, or, oops, might inadvertently end up in the finished food product.
That\'s a mouthful, but, I think it comes to your point, Duane and
Carol, that this is a particularly sensitive dimension of the topic but
it\'s not the statement that\'s trying to cover more than that, so, it
comes back to explain that further in the text. That\'s obviously up to
you guys to say well, that\'s \--

MR. GRANT: I\'m sorry to interrupt, but, actually, I think that is what
the topic sentence is trying to cover is, specifically the issue of
pharma PMP\'s in food crops.

MS. DILLEY: Well, ask the question then. I mean, I heard Randy say it\'s
broader than that. That we want the integrity of the food and feed
system to include not only food products but feed and other \-- the
whole range of products for inadvertent, whatever word we\'re going to
use. So, then the question is, is it buried too much in this one for
your satisfaction. Do we need \-- you know, that\'s the question in my
mind.

MR. GRANT: I guess I would just make the point that I\'d have to go back
and look at other issues that we\'ve raised, but, if the issue is simply
so broad that we\'re talking about a regulatory system that ensures
integrity of the food and feed system that really doesn\'t get at all to
the issue of the potential of PMP\'s in food.

MS. DILLEY: Okay. Mardi, Michael, and then Leon.

DR. MELLON: This is suggested language that might address it. I\'m not
sure, but, the first sentence might be the U.S. regulatory system must
ensure that genetically engineered food crops used to produce non-food
products are appropriately contained, address safety considerations, and
ensure the integrity of the food feed system.

MS. TUCKER FOREMAN: Say that again.

DR. MELLON: The U.S. regulatory system \-- and, in fact, there are \--
you know \-- it\'s an interlocking system that will be required to
accomplish this \-- must ensure that genetically engineered food crops
used to produce non-food products are appropriately contained, address
safety considerations, and ensure the integrity of the food feed system.

And then I think \--

DR. SCHECHTMAN: Can I ask one question? Actually, this sort of goes to
Duane\'s concern about this and I heard what you said about from the
first sentence not capturing everything. The second sentence at the
three sentence introduction though, of the three sentence topic
sentence, goes very specifically to the fact that some people are
concerned that it\'s not going to prevent these things from entering the
food supply and isn\'t that really specifically what the concern is that
you raised?

Isn\'t that really the nub of the issue?

DR. SHURDUT: I don\'t know necessarily. There may be some perceptions,
yeah, that folks still think the regulatory system is stringent enough
so you may want to say the regulatory system alone can assure.

DR. DYKES: I was going to go to the point you were raising. I don\'t
think the first three sentences \-- I like the three sentences. I don\'t
think they\'re the topic. In my mind the topic sentence is the one that
was highlighted. There is a major concern regarding the use of food
crops to produce specialty products in the food crops or specialty
products derived from them although never intended for food or feed use
will inadvertently end up in the finished food or feed product.

I think that\'s the topic. And I don\'t think \-- I think I\'m with the
crowd. I think there\'s some questions about whether you pin the whole
\-- and I acknowledge what you\'re saying, I think, but, it\'s fair to
require the regulatory system alone to address all these issues.
Obviously it\'s a huge part of it, but, there\'s more to it than that.
So, maybe the topic sentence is that one sentence.

And then we take those other things out and I think it flows well to say
some members feel one way and other members feel another way and we go
through them. But, that, to me, is the topic sentence.

MS. DILLEY: Does that cover or is that too narrow from your perspective,
Randy? I don\'t know.

MR. GIROUX: I guess I\'m struggling with making it so narrow to food
crops because from \-- I think from the food supply\'s perspective a
pharma coconut ending up in a corn shipment and ending up in somebody\'s
food will do as much damage as a kernel of corn, a pharma corn showing
up. I mean, it\'s the presence of a non-food pharma/industrial substance
showing up in food that\'s the issue. It\'s not the vehicle of the
delivery.

So, by saying it\'s only food crops does that mean that we don\'t care
if somebody uses a non-food crop to make \-- if there is the potential
that that grain/seed or whatever it is can end up in the food supply. I
mean, for me the issue is I don\'t want to see specialty products that
aren\'t meant for food in food.

DR. LAYTON: Right. I think he\'s stronger than you were.

MR. GIROUX: I am being, yes.

MS. DILLEY: You\'re saying I don\'t care where it comes from, I just
don\'t want it in my food. To say that grown in food crops only limits
it to things grown in food crops. Now, I kind of get it, what you\'re
saying if that\'s what you\'re saying.

DR. DYKES: So, it\'s a major concern regarding the use of food crop or
any crop to produce specialty products that may inadvertently end up in
food or feed when they\'re not intended to be there.

MS. DILLEY: Right.

MR. GIROUX: Correct.

MS. TUCKER FOREMAN: Michael, would you \-- could Michael get this
sentence? It\'s not on there, is it?

DR. LAYTON: It\'s in the text. It\'s right there.

DR. DYKES: It\'s in the text already.

DR. SCHECHTMAN: There is a major concern.

MS. DILLEY: Say it again. So, there is a major concern regarding the use
of crops to produce. Would you then take food \--

DR. DYKES: Food crops or any crops.

MS. DILLEY: Food or any crops? Just crops. To produce specialty products
or medical/industrial. That\'s still got a question. I don\'t know what
you guys think of that. But, \--

DR. LAYTON: E.g., medical and industrial?

MS. DILLEY: Products.

DR. CRAMER: So, tell me how the crops that\'s never used in a food end
up in food.

MS. TUCKER FOREMAN: Randy and \--

DR. LAYTON: Kenaf is related to okra. Kenaf is related to something. I
don\'t know, I\'m just throwing out something.

DR. MELLON: The possibilities are remote but it has to be either
physical \-- it\'s probably more likely to be physical especially in
some sort of situation when people are handling lots of different kinds
of products.

MR. OLSON: It\'s better to say food crops or any other substance or
something like that because food crops is an issue.

MS. DILLEY: Okay. So, food crops \--

DR. HUNT: Any crops \--

MS. DILLEY: Other sources?

DR. HUNT: \-- not intended for food. Just keep it like that, that\'s not
intended for food.

DR. DYKES: I don\'t think it\'s necessary to limit it to any crops not
intended for food. I think it\'s the result of product that was not
intended for food. Whether we\'re producing a food crop to start with,
that\'s irrelevant. It takes care of the 99 percent of that, but,
that\'s not the point, in my view.

DR. LAYTON: Randy was much broader than food crops.

DR. DYKES: Yes.

MS. TUCKER FOREMAN: Randy, could you \-- I, you know, I bought Randy\'s
argument because I thought he made it that it could go indirectly into
that food product. What did you say?

MS. DILLEY: It was going the way you said. Could you say it again?

DR. LAYTON: There is a major concern regarding the use of crops to
produce specialty products \--

MR. GRANT: Non-food products instead of specialty products.

MR. GIROUX: If you break the issue down it\'s what is the risk of it
showing up in a finished product. There\'s a lot of discussion about
food crops because the risk is greater if you make it in food crop and
it ends up in the food.

DR. LAYTON: I\'ve got it.

MR. GIROUX: If I put it in the coconut then when I calculate \-- when I
look at the risk, the risk is much lower and, so, the discussion is much
different so that the discussion would be relative to the risk of it
being in the crop and, so, \--

DR. DYKES: That\'s why I suggested food crops or other crops because if
somebody\'s reading this they\'re going to go, oh, food crops, I\'m
familiar because they\'re broader. They\'re saying food crops or other
crops if they inadvertently end up in food or feed. That was my intent.

DR. LAYTON: So, food or other crops.

MS. DILLEY: Food crops or other crops.

MR. JAFFE: You have to get engineering in there. The whole part of this
is that they\'re engineered to produce specialty products. There are a
lot of crops that are used to produce specialty products all the time. I
mean, I think that the whole point of this is you\'re engineering them
to produce it.

MS. DILLEY: Got it.

DR. MELLON: Yeah, that\'s for sure.

MS. DILLEY: So, the use of genetically engineered food crops or other
crops?

DR. LAYTON: No.

MS. DILLEY: Where do you put that?

DR. LAYTON: Engineered to produce specialty crops.

DR. SCHECHTMAN: Food crops or other crops engineered to produce
specialty products not intended for food or feed use.

MR. CORZINE: I think that needs to be there.

MS. DILLEY: Yes. I don\'t hear any difference of opinion on that.

MS. TUCKER FOREMAN: Say it again, Michael.

DR. SCHECHTMAN: There\'s a concern, a major concern regarding the use of
food crops or other crops genetically engineered to produce specialty
products not intended for food or feed use.

DR. DYKES: I think you pick up the end of that sentence, never intended
for food or feed use.

DR. SCHECHTMAN: Never intended.

DR. DYKES: Never intended to end up in finished food or feed products.
It reads well. It captures the essence of the argument.

DR. LAYTON: So, what you\'re saying now is there is a major concern
regarding the use of food or other crops genetically engineered to
produce specialty products never intended for food or feed use.

DR. DYKES: Inadvertently end up in the finished food or feed product.

MS. TUCKER FOREMAN: You know, not specialty products.

MR. CORZINE: I would say non-food.

MS. DILLEY: Non-food.

MR. CORZINE: Non-food instead of specialty. Right, Carol?

DR. LAYTON: Non-food. Okay. Let\'s get it right.

MR. JAFFE: Instead of regarding you would say that. There\'s a major
concern that the use of food or feed crops never intended for food or
feed will inadvertently. You can say that.

DR. DYKES: Yes. Will inadvertently end up in finished food or feed
product.

MR. JAFFE: Change regarding to that. Replace regarding with that.

MS. DILLEY: So, there\'s a major concern regarding the use of food or
\--

MR. JAFFE: That. Replace regarding with that.

MS. DILLEY: There\'s a major concern that the use of food or other
crops. That doesn\'t make sense. Is it food crops or other crops?

DR. DYKES: Just food crops or other crops.

MS. DILLEY: Food crops or other crops genetically engineered to produce
non-food products never intended for food or feed use will inadvertently
end up in the finished food product.

DR. SCHECHTMAN: There\'s a grammatical problem with the last part of the
sentence.

DR. VAN EENENNAAM: Take out the use. Major concern that food crops or
blah, blah, blah and then it makes sense, doesn\'t it.

MS. DILLEY: That food crops or other crops genetically engineered to
produce non-food products never intended for food or feed use. There\'s
some commas in there. Will inadvertently end up in the finished food
product.

MR. GIROUX: I\'d like to see us replace will with could.

DR. SLUTSKY: Can\'t you delete non-food?

DR. VAN EENENNAAM: Yeah, non-food, that can go.

DR. LAYTON: It\'s redundant.

MS. TUCKER FOREMAN: No, it\'s not redundant because you\'re \-- well,
\--

MS. DILLEY: We really, really mean it.

MS. TUCKER FOREMAN: I think you\'re right.

DR. LAYTON: It\'s redundant?

MS. TUCKER FOREMAN: Yeah.

DR. LAYTON: Okay. So, to produce products never intended for food or
feed use could inadvertently end up in a finished product. Finished
product.

MR. JAFFE: Food product.

MR. GRANT: Food or feed product.

DR. MELLON: Because we\'re saying there\'s a major concern we could
limit the topic to food crop. I mean, there is a major concern that food
crops genetically engineered to produce products never intended would
end up in the food. There are, I would say, very, very \-- there are
concerns, but, they are minor. The use of coconut is one. Trust me, I
worked hard for crops that are not used in food and they are almost
impossible to find.

MS. DILLEY: Are people okay with going with Mardi\'s proposal in terms
of concentrating on food crops as the major concern?

DR. DYKES: I think Mardi answered the point since we\'re talking major.
The major concern is the food crops.

MR. JAFFE: Feed still stays in.

DR. MELLON: Yeah, feed stays in.

MR. JAFFE: Feed stays in.

MR. OLSON: Yeah, I think you pick up feed in the comments.

MR. GIROUX: If you\'re going to focus on food then take feed out.

MR. OLSON: You can take out feed in the comments too.

DR. SCHECHTMAN: No. I think what I \-- maybe there\'s sort of two
different places going on here. I think there was a concern that, the
major concern regards the use of food crops and that it might end up in
food or feed.

MR. JAFFE: That\'s right.

DR. LAYTON: Yes, they could end up in food or feed.

MS. DILLEY: But, you want the last one to be the finished product is
food.

DR. SLUTSKY: Mardi, are you saying that the biggest concern is whether
it ends up in food products?

DR. MELLON: I\'m saying, yes, that the big concern is the use of food
crops that would end up in food products. There are also concerns that
it might end up in feed but I would say that\'s remote. There are also
concerns that non-food, you know, crops may also pose a risk but, all in
all, I\'d say that\'s small.

DR. SLUTSKY: So you would just delete all those references to food and
feed and \--

DR. MELLON: I\'m willing to have it, you know, later on because there
were concerns of finding it in food but I just don\'t think that\'s the
major concern.

MR. CORZINE: I would say, you know, you\'re right. I mean, we focus on
the food products but we\'ve got two things going here, I think. One is
that, you know, we had an issue with splitting food and feed a few years
ago that we don\'t want to go back to. And it is a major concern if you
would get something in the feed system that you didn\'t want there as
well.

So, whether you address it in the topic line or the issue line or
underneath you really need to be addressing feed as well.

DR. MELLON: I defer to you all to know. I think we should leave it in.

MR. GIROUX: Well, food crops, they\'re all feeds.

MR. CORZINE: Yeah.

DR. LAYTON: All food crops are feed crops.

MR. CORZINE: Yeah. One way or the other.

DR. LAYTON: Let\'s keep it in. Unless we\'re only talking about sweet
corn, but, you could probably feed that.

(Discussion off the record)

DR. LAYTON: I think I know where Michael\'s coming from and it was what
you all talked about this morning about using the word approved. You
don\'t want to use the word approved because that\'s not what the FDA or
the USDA \"does\".

MS. ZANNONI: But, that\'s not the point.

DR. LAYTON: I understand that.

MS. ZANNONI: You can change it to procedure or whatever.

DR. LAYTON: Whatever you want to put it. I understand what you\'re
saying. We\'ve just got to find the right word.

MS. TUCKER FOREMAN: I\'m not sure. I like the sentence the way it reads
now. Why are we changing it?

MS. DILLEY: I think because she\'s raising up another dimension and that
you can go through \-- its primary market may not be the food and feed
system but you go through the regulatory process. Intention is the one
that doesn\'t completely cover it. Maybe that\'s not a major concern
though, Lisa.

MS. TUCKER FOREMAN: The thing is it doesn\'t make any difference if
it\'s been \-- I may not understand, Lisa, but, it doesn\'t make any
difference how many approvals it gets. It\'s not supposed to be in the
food and it ends up in the food, the product is harmed, that the
finished food product is harmed, and the public goes berserk. The FDA
can approve them and say those proteins have been in your food supply
forever. It\'s a protein associated with the pharmaceutical and
industrial use. The consumer doesn\'t want it in his breakfast food.

MS. ZANNONI: Right, so, it\'s a market issue.

MS. DILLEY: So, I think it links back to the major concern piece of it
too. So, if we\'re sticking with a major concern then I think it is the
intended language is the appropriate one. Does that make sense?

DR. LAYTON: So, we\'re comfortable?

MS. TUCKER FOREMAN: I was just going to say I think this is changing the
topic sentence. The first sentence here is an important and good change,
but, it really is what this is about.

MS. DILLEY: Okay. So if we have a sentence \-- I\'ll read it one more
time and then we can move on to the rest of the discussion.

There is a major concern that food crops genetically engineered to
produce products never intended for food or feed use but inadvertently
end up in a food or feed product. That\'s the main topic statement.

DR. DYKES: That to me is the topic.

MS. DILLEY: Okay. Alison?

DR. VAN EENENNAAM: I just wonder if we should put medical/industrial in
front of products just for people that don\'t really \-- aren\'t really
on board with what the topic\'s about until they read that potentially.

DR. LAYTON: We\'ll put e.g.

DR. CRAMER: No. Actually, don\'t put it there. Put it after food or feed
and then parenthetically you put, you know, e.g.

DR. LAYTON: Parenthetically e.g.

DR. CRAMER: Yeah, e.g., pharmaceutical or industrial.

MS. TUCKER FOREMAN: I\'ve got a problem with \-- I think I\'d probably
prefer to see it go in the actual \-- I don\'t like parentheticals. To
produce pharmaceutical or industrial products never intended for food
and feed use. I think it\'s reasonable. Put it into the body of the
sentence. Then it reads fine then.

MR. JAFFE: I think it\'s medical. I think pharmaceuticals are a term of
art. I think the legal definition in the fact sheet that not all things
are biologically end up being pharmaceuticals. They\'re biologics. So,
if you\'re making a biologic here you\'re limiting yourself to
pharmaceuticals.

MS. DILLEY: Our FDA expert is nodding.

MR. JAFFE: I\'m not an expert on this, but, the FDA person can speak
better.

DR. JONES: There are vaccines that are being developed in plants and
they may not be covered by a drug term so a medical product would cover
both drugs and biologics.

MS. DILLEY: So is everybody okay with clarifying product to be
industrial or medical?

DR. DYKES: Instead of specialty?

MS. DILLEY: Yes.

DR. DYKES: I agree. Especially if it\'s confusing.

MS. DILLEY: So, if that\'s the topic statement then does that mean that
some members, others, still others goes into the text or does that
change now given that we\'ve refined the topic statement?

DR. DYKES: In my opinion I think we\'ve not done some some ways and some
others in the topic. I think we leave that as the topic. We keep the
some/some/somes, but, we put them down in the text. They\'re not a part
of the topic to me because I think we clearly defined what the topic is.

MS. DILLEY: Because everybody is on board with that, that\'s a major
concern. Okay. So, then you move the something that into the explanatory
text.

DR. DYKES: Right. And they read some think and the some think reinforces
our topic.

DR. VAN EENENNAAM: Where\'s the first sentence?

MS. DILLEY: It\'s gone.

DR. VAN EENENNAAM: Have you replaced it?

DR. LAYTON: I don\'t know that the somes and somes are fair.

DR. CRAMER: Just save it.

DR. DYKES: Just save it. We may want to put them someplace else within
the text.

DR. LAYTON: I like the way that Carol had written up her text. I don\'t
know if it fits right or not. It read very smoothly to me.

MS. DILLEY: So, if you were go to the side-by-side and you need to go
the bottom of the comments on the right-hand side you\'ll get to
Carol\'s suggested language.

DR. LAYTON: I can tell you what it says. It says new genetically
engineered organisms designed for medical and industrial markets could
offer substantial health and economic benefits. There are a number of
new products under active development in these categories and the
majority of those being produced in plants have been engineered for
production use in important food crops.

A major concern regarding the use of food crops to produce medical and
industrial products is that the food crops in which they are grown or
the products derived from them, although never intended for food or feed
use, will inadvertently end up in a finished food product.

Food processors and consumers believe it is unlikely that any regulatory
process or containment system can assure that these products will never
enter the food supply. Even if the products are safe, most consumers
should not want them in their food supply and are likely to respond
negatively to the unexpected, unintended presence.

You know what, I\'m not sure that we need to reiterate all that now that
I read it again.

MS. DILLEY: Yeah. The first two sentences go on to explain. I think then
the question is that middle sentence is the one that we reconfigured and
put as a topic statement.

DR. LAYTON: It\'s gone.

MS. TUCKER FOREMAN: The concern\'s already in it.

MS. DILLEY: Right.

MS. DILLEY: And then where you get \-- I think if we still have some
think, others think, still others think then that\'s where we put it.

DR. LAYTON: Yeah, and not ending of it right there.

MS. DILLEY: Because that\'s then a comment on whether the regulatory
system can do x, y, and z and different people have different views on
that. Is that kind of the general formulation of the explanatory text
and then we need to come up with language that \--

MS. TUCKER FOREMAN: I want to say I haven\'t yet totally bought into not
having this in the introductory boldface, but, let\'s go through and see
if we can work it out.

DR. LAYTON: So, let me go back to the original text.

DR. SHURDUT: Just one point there. I don\'t know if that\'s factually
correct though that there are no new products under active development
that would use the plants. They\'re not necessarily imported food crops.
I mean, there\'s a dramatic movement away.

DR. LAYTON: Do you want to say \--

DR. CRAMER: But, that\'s not true.

DR. LAYTON: Okay. I got that. I said let\'s go back to the original
text, okay. Let\'s start from the original.

DR. VAN EENENNAAM: I wouldn\'t delete it. I\'d move it because you\'re
not coming back.

DR. LAYTON: Wait, wait.

MS. TUCKER FOREMAN: Well, let\'s keep some of it because it reads a
little better there.

DR. CRAMER: Well, I was only asking to change one word.

DR. LAYTON: Right.

MR. JAFFE: This is the problem with not seeing Carol\'s in the red line
strikeout. If you saw Carol\'s in the red line strikeout and if you have
her draft she\'s only made about six one-word changes and then you\'re
taking the word specialty out so I wish you would either work from the
regular draft we have and make her changes, or, otherwise, people should
look at the red line strikeout that she has on the desk because we
didn\'t get \-- it really is almost the same and so they\'re really
editorial changes and it does read a lot better, but, I don\'t think
those are controversial if one looked at just what those differences
were.

The problem is on the side-by-side you can\'t see what those differences
are.

DR. DYKES: I think we\'re all fine with Carol\'s statement.

DR. LAYTON: Yeah, Carol\'s changes are red lined on my other edits and
it is \--

MS. TUCKER FOREMAN: There are only ten of these hard copies so you all
can share.

(Discussion off the record)

DR. LAYTON: Scoot down about to page 12. This is Carol\'s comments, red
lined.

MR. GIROUX: These are in the colorful draft? They\'re red lined in the
colorful draft.

MS. DILLEY: Right. I mean, yeah, in the colored draft there are Carol\'s
edits but there\'s also additional language. Because, Randy, I put in
some of your stuff there. Okay. So, we\'ve got it up there.

MS. TUCKER FOREMAN: Can you drop the major change?

MS. DILLEY: Take out a major concern?

MS. TUCKER FOREMAN: First of all, you changed the majority to many.

DR. CRAMER: No, not even many. I would say some.

DR. LAYTON: Some.

DR. CRAMER: At this point there are dramatically few.

(Discussion off the record)

MS. TUCKER FOREMAN: I think the important element is that there is
"important food crops." You want this in red?

DR. LAYTON: No, it\'s here. I have it.

MS. DILLEY: She just has to get it in a document that can be modified.

(Discussion off the record)

DR. LAYTON: See, that\'s the problem I have.

MS. TUCKER FOREMAN: If you cut and paste it doesn\'t show up. That\'s
why I\'m offering you the hard drive.

DR. LAYTON: But, I have it on the other shot. That\'s the other part,
Carol.

MS. DILLEY: While Cindy\'s trying to get the text up technologically,
Greg, you had a comment and then Carol?

MR. JAFFE: I guess I\'m trying to figure out where we\'re going with all
of this. I mean, I like the topic sentence we have now. My suggestion, I
mean, I was comfortable generally with the whole text that was
underneath it. I think Carol\'s things of changing specialties are fine,
but, I think they\'re minor things so I think we should.

But, the one \-- there was a proposal I have is I don\'t think we need
to repeat the topic sentence in the text. I would delete that sentence
and instead replace the first sentence from our original topic sentence
about the regulatory system must ensure appropriate containment in that
place and then move on.

I think that\'s a very important issue and that needs to be covered and
then I think the rest of it flows very nicely from that. So, you have
the first two sentences introduce the topic. What we\'re talking about
is these products might have some benefits. They\'re being developed.
Whether you say majority or not, we can figure that out. And then you
say the regulatory system needs to ensure these are safe and then you
say some members say this, other members say that.

MS. TUCKER FOREMAN: Sounds good to me.

DR. LAYTON: Does that mean we can delete the food processors and
consumers believe blah, blah, blah?

MR. JAFFE: No. No.

DR. LAYTON: You want all that still too?

MR. JAFFE: Yeah, all that\'s in. I don\'t think we need to put the other
some. I think the some members that was in the topic, those are deleted
because I think those are covered in the text.

MS. TUCKER FOREMAN: You can take those out of the topic sentence and put
them in the text.

MR. JAFFE: I\'m saying use the \-- we have a new topic sentence and we
had three old topic sentences. Take the first of those and put it where
the old topic was, that sentence number three in the discussion. The
other two topic sentences about some members and others accept I would
delete those because I think they\'re covered in the remainder of the
discussion.

DR. LAYTON: Okay.

DR. DYKES: I would add just before the change I\'d make one caveat. I
think I like the way Carol has addressed the regulatory process in her
suggested draft because she has broadened it to just she says unlikely
that any regulatory process or containment system. I think it\'s more
than just relying on the regulatory process so I think Carol has
addressed the first topic, original topic sentence, in her draft.

I would propose we take the new topic sentence. I don\'t know that
we\'ll need some think, some think anymore. I think we take the new
topic sentence and Carol\'s suggested draft and text and put it in
there. Then we could change major to some and some of those words. But,
if we do that we\'re 99 percent of the way there.

MR. JAFFE: Where are you referring to in Carol\'s draft?

DR. DYKES: If you look at Carol\'s document it\'s on line 485. Food
processors and consumers believe it is unlikely that any regulatory
process or containment system can assure that these products will never
enter the food supply. I think that\'s the real issue.

DR. LAYTON: That\'s already in there.

MS. TUCKER FOREMAN: He said \--

DR. DYKES: I\'m saying what Greg\'s saying. We\'ve got go both the old
topic sentence and add it. I\'m saying we don\'t have to. Carol\'s
already got it covered. Use the new topic sentence in Carol\'s draft and
then we go through and wordsmith major to some or some of those kind of
things.

MR. JAFFE: She\'s adding the word any. She\'s added the word any from
the Chair\'s draft.

DR. DYKES: Yeah. Any regulatory process or containment system.

MR. JAFFE: But, that containment system was in the Chair\'s draft.

DR. LAYTON: It was in the Chair\'s draft.

MR. JAFFE: It was in the Chair\'s draft, so, I mean, I\'m comfortable
with adding the word any, but, I don\'t think that takes away from the
sentence of that the regulatory system must ensure appropriate
containment, address safety considerations, and ensure the integrity of
the food system. I think that that\'s a very important point, in my
opinion, that still needs to be covered and I don\'t think that sentence
covers it.

UNIDENTIFIED FEMALE: Do you want any out?

MS. TUCKER FOREMAN: No.

MR. JAFFE: I\'m comfortable with the word any in there but I don\'t
think that adding the word any takes away from the point. I think that
those \-- I don\'t think those two sentences that Michael has referred
to and the original topic sentence, I don\'t think they\'re synonymous.

MS. TUCKER FOREMAN: You\'re saying that after the word food crops in the
first sentence \--

MR. JAFFE: Right.

MS. TUCKER FOREMAN: \-- then you go to the second sentence. Then you say
\-- then you take what used to be the topic, the first topic sentence.

MR. JAFFE: The regulatory system for genetically engineered crops have
produced a non-food product \--

MS. TUCKER FOREMAN: Move it there.

MR. JAFFE: \-- must ensure appropriate containment, address safety
considerations, and ensure the integrity of the food system.

MS. TUCKER FOREMAN: And then you say food processors and consumers are
worried that that can\'t happen.

MR. JAFFE: That\'s right.

DR. DYKES: He\'s talking about any regulatory process.

MS. TUCKER FOREMAN: And then you go on.

MR. JAFFE: Any regulatory process or containment. That\'s right. You
need that transition. You need that sort of \-- you need that or you
lose it.

MS. ZANNONI: I\'d rather have some and some because the rest of this
doesn\'t have the other side of it. This is so \-- I mean, this is
basically saying these have a lot of value but it\'s never going to
happen.

MS. TUCKER FOREMAN: But, I worked off the \-- before Pat added back in
the sentence of the people who are sure that some believe that there is
a system \--

MR. JAFFE: It\'s right there in the text.

MS. TUCKER FOREMAN: \-- so if you take what\'s there on mine and add the
\--

DR. LAYTON: It\'s there.

MR. JAFFE: It\'s there.

MS. TUCKER FOREMAN: Oh, it is?

DR. LAYTON: It\'s there.

MS. TUCKER FOREMAN: No, no, it\'s not in that. So, if you take that and
start from the end and go to the document that Pat had on our desk when
we came in this morning then you have all three positions laid out, I
think, pretty fully.

DR. SCHECHTMAN: Okay. So, if I can \-- let me see if I can go back,
reiterate where we are. I think we\'ll have to go back on those other
positions in just a second. We have the new topic sentence which is up
there, there is a major concern. Then we are going to Carol\'s draft for
the first two sentences after which we take the original \--

MS. TUCKER FOREMAN: No, then you\'d strike the sentence with the major
concern.

DR. SCHECHTMAN: Yes, yes. Then you strike that sentence and in its place
we put the original regulatory \-- the first sentence of the topic. Then
from there we continue down, food processors, it\'s unlikely that any
regulatory process, et cetera, et cetera. We go through until the end of
Carol\'s text.

MR. CORZINE: Is it too strong?

DR. CRAMER: We have to say some food processors because I\'m a consumer
and I don\'t believe it.

MR. CORZINE: Maybe we put most or some food processors and consumers.

MS. TUCKER FOREMAN: You could say some are concerned.

DR. LAYTON: Some? Okay.

MS. DILLEY: Food processors and consumers believe that it is unlikely.
Okay. And then?

DR. SCHECHTMAN: And then from there we go back

to \--

MS. DILLEY: Even if the products are safe.

DR. SCHECHTMAN: \-- the text that is \-- is it Abby\'s? Is it the
original?

MS. TUCKER FOREMAN: Well, this was on our desk this morning.

MS. DILLEY: Wait a minute. I think there\'s one piece that is not in
Carol\'s or Pat\'s which is, I think, Randy, your comment, so, I need to
\-- the last part of this says some think and others think and then I
think you had raised the point of other committee members believe that
with adequate regulatory oversight and appropriate industry standards.
So, there was a third dimension to that.

MS. TUCKER FOREMAN: And I thought that was what Pat put on the table
this morning.

DR. SCHECHTMAN: No. No.

DR. LAYTON: That is topic 23.

MS. DILLEY: It\'s in the colorful \-- colored draft.

DR. SCHECHTMAN: That additional sentence is starting on line 475 in the
colorful draft and it reads other committee members believe that with
adequate regulatory oversight and appropriate industry standards the
likelihood of these products entering the food supply is remote.

DR. LAYTON: That is Randy\'s comments and my side-by-side it\'s in red.

DR. MELLON: And in either case, what are the two cases? In any case.

DR. SCHECHTMAN: And yet we haven\'t put that back yet.

MS. DILLEY: Right. Not yet. So, I don\'t know. Maybe we ended it others
believe, some, some others.

MR. GIROUX: I am willing to rescind that comment since I think it\'s
captured it.

MS. DILLEY: Okay.

DR. LAYTON: Okay.

MS. DILLEY: So we can stop at remote, right? Is that what you\'re
saying, Randy?

MR. GIROUX: Yeah.

MS. TUCKER FOREMAN: Stop after remote?

DR. SCHECHTMAN: Yes.

DR. LAYTON: Ron?

MR. OLSON: Just one point. Food processors are saying like any will
never. I think the food processors have said you can grow it under
containment. You can grow it in place of. It doesn\'t have any
possibility of contaminating. It\'s not a never. It\'s under these
conditions you can grow it. You can\'t say they can\'t grow drugs in
corn because there probably are situations that you can do it where
it\'s safe in the food supply.

DR. LAYTON: In a greenhouse.

MR. OLSON: So, never is a little strong though, I think. It\'s line 486
on Carol\'s draft.

MS. TUCKER FOREMAN: 486.

MR. OLSON: On Carol\'s draft.

DR. LAYTON: Not Carole.

MR. OLSON: Carol Tucker Foreman.

DR. LAYTON: Oh, you want copies. I don\'t have her copy.

MS. TUCKER FOREMAN: It says some food processors. We added some in
there.

MR. OLSON: You added some which helps.

MS. TUCKER FOREMAN: Some food processors and consumers will believe it
is unlikely that any regulatory process or containment system can assure
these products will never enter the food supply.

MR. JAFFE: So, now you want to delete the any?

MR. OLSON: No. I would say never. It sounds a little too strong maybe
because I think the food processors have said if you can grow it in a
greenhouse or grow it in a state that doesn\'t have any cross
contamination.

MS. TUCKER FOREMAN: And if you will excuse us from any liability if it
ever does, which really is saying they don\'t think that it\'s possible.

MS. DILLEY: Is it never? It\'s kind of a double negative so I don\'t
know if you can \--

MR. OLSON: That works better than never for me.

MR. JAFFE: Yeah.

MS. DILLEY: Will not enter the food supply.

MR. OLSON: Yeah. I think never\'s just too strong of a word there.

DR. HUNT: Well, we could talk about, you know, getting one hundred
percent containment is extremely difficult or something along those
lines.

MR. OLSON: But, I don\'t think they\'re saying never.

DR. MELLON: But, the never applies to the \--

MS. TUCKER FOREMAN: Let me say. I think that the not rather than the
never is acceptable here. But, a more general principle. If we\'re going
to go to the some members think this and some members think that, those
of us who think a particular way get to say it our way but not the
other, or, we\'ll be here forever.

MS. DILLEY: Right, that\'s correct, and Ron was adding his food
processor\'s point of view so we just need to sort through that. It
sounded like we ended up with not enter the food supply was okay.

MR. OLSON: It says the same message.

MS. TUCKER FOREMAN: That\'s okay.

MR. CORZINE: My question was, and I think it addresses what Carol was
sort of asking or stating. I thought maybe we were getting to some of
these changes where the some/some we won\'t need. Is that right?

MS. TUCKER FOREMAN: What\'s that?

MR. CORZINE: We won\'t need the some/some sentences, some think
sentences, if we get this language where we\'re working towards, Carol,
working off of your draft.

MS. DILLEY: I think you\'re right in that we are, in this draft, if
we\'re working off of Carol\'s draft, we stay with that until we hit the
some committee members believe that the federal regulations need to
acknowledge that it\'s impossible blah, blah and then other committee
members, so, the question I think is right in that are we trying to move
away from that or are we trying to make sure we get all the different
angles and I don\'t know.

MS. TUCKER FOREMAN: Yeah. If I can just say that I think that we
probably have to take some food processors and consumers out and say
some committee members believe that. Then you get down and some believe
that the federal regulations need to acknowledge and then some believe
that with appropriate oversight it can be done.

MS. DILLEY: Is that your preference, Carol, I mean, to go to some
committee members say x, y, and z or do you want to keep it in a more
general in terms of some consumers and food processors believe? I mean,
I don\'t know. I think that\'s \--

MS. TUCKER FOREMAN: I really \-- yeah, I would rather have it say some
committee members.

MS. DILLEY: Committee members. So, that\'s your preference.

MS. TUCKER FOREMAN: Because I think that\'s really what we\'re talking
about and I don\'t believe there are very many people whose primary
connection to the food system is as consumer, not as producer, not as
academic, not as anything but consumer really don\'t think that the
system can protect them.

MS. DILLEY: Okay. So, your preference \--

MS. TUCKER FOREMAN: Again \-- again, both the grocery manufacturers and
the food processors filed comments saying I don\'t think so either
because unless you will excuse them from any liability when the
unthinkable happens.

MS. DILLEY: Okay. So, I mean, one option, I mean, just to get back to
what we\'re trying to do is to go either some members think versus
trying to person out in terms of consumers versus food processors versus
other stakeholders so that\'s what we\'re trying to wade through in
terms of getting the points on the table or in the explanatory text as
well as how you want to attribute those different points of view.

Michael and then Carole Cramer.

DR. DYKES: I was going to \-- I would like to see if we could drop the
some members feel and other members feel, but, I\'m where Carol is. I
think if we state this as strongly as we are \--

MS. DILLEY: Yeah.

DR. DYKES: \-- perhaps we can get down to the point that we\'re saying
this is a major concern and that any regulatory is unlikely that it\'s
not going to happen, it wouldn\'t get to a full stop in there before we
get into some \-- just I\'m trying to get fewer of these where we\'ve
got some say one thing and some say another thing. I think we\'re pretty
well in agreement here that this is a major issue and we\'re not going
to be able to keep this stuff from ever happening.

MS. DILLEY: Right.

DR. DYKES: Better said in the text, but, I think that\'s where \-- does
anybody really want to hang onto and other members feel that the current
system can handle this?

MS. ZANNONI: What are you going to say on the other side, the tech
companies and I mean, if we start out with food processors and consumers
then what are you going to say on the opposite end, academics?

DR. DYKES: I don\'t think you need say about anybody else to me.

MS. DILLEY: I think what Michael\'s saying is that can we stick with the
theme of this is a major issue and we don\'t think a regulatory system
and/or other containment, whatever measures are going to completely a
hundred

percent \--

DR. DYKES: Right.

MS. DILLEY: \-- not result in none of this stuff ever ending up in our
food system, right, so, you can\'t have a foolproof system is basically
what you\'re saying and it\'s a major issue.

The question then is if you \-- how much further do you need to go?
Because if you need to go further then you get into some members think
and others members think. If people are satisfied with going as far as
it\'s a major issue and you can never develop a foolproof system then we
don\'t necessarily need to go into the some members think, other members
think.

DR. CRAMER: I don\'t agree that we can never develop a foolproof system.
And I think that the industry is going in many ways. There\'s transgenic
and non-transgenic. People are going with (unintellgible), people are
going with non-food, non-feed, and so we\'ve got to be careful that we
don\'t emerge here with a message that, no plant-based medical products
are off the table.

DR. DYKES: I was just talking about some and some, that we won\'t need
that.

MS. DILLEY: So, it\'s a major issue, yes, everyone can agree on, whether
you get a foolproof system, people are divergent on that, so that\'s
where we need to start making the some think and others think and still
others think.

MS. ZANNONI: But, if you start out with the beginning that these could
offer substantial health and economic benefits it seems like you\'d want
to go toward how do you get them on the market then.

MS. DILLEY: I think that\'s a different topic.

MS. ZANNONI: Well, we had it as the first sentence and then you go into
well, it\'s not a reality, you can\'t, so it doesn\'t make sense. Why
are you \-- you\'re saying you have to know benefits. So, instead, we
should turn it around. How do you get them. There are some issues with
it, but, how do you get them on the market.

MS. TUCKER FOREMAN: By growing the non-food crops.

MS. DILLEY: See, that\'s where \-- yeah, I mean, how that plays out. So,
Mardi?

DR. MELLON: Well, \--

MR. JAFFE: I\'m comfortable with deleting that first sentence. I think
that was put in because people wanted that balance and didn\'t want to
just be negative here. They wanted a sentence that sort of said that
there is some potential positives, it\'s worth exploring these, but,
these are the concerns.

DR. MELLON: It seems to me that \--

MR. JAFFE: But, I\'m comfortable taking that sentence out \--

MS. ZANNONI: I don\'t want it out.

MS. DILLEY: She doesn\'t want it out.

MR. JAFFE: \-- and I agree that it\'s not \-- going into more detail on
that would \-- gets away from the main issue here which is the main
issue is the concern that these things are going to get into food.

MS. DILLEY: Mardi and then Duane.

DR. MELLON: But, we \-- our topic sentence is \-- just talks about the
major concern that food crops used to produce these products will result
in the presence of these substances in the food system. And then we say
\-- I mean, it seems to me that if we remember that that\'s our topic
sentence then we can say that this is a big problem and that most people
feel that the use of the food crops, I mean, will, in fact, \-- I\'ve
forgotten how I said \-- but, it will create this problem.

Now, that leaves open kind of Carole\'s set of solutions which is that
the technology might go ahead by not using food crops.

DR. CRAMER: Or, I mean, there are situations and we can\'t be too
exclusive, so, flax is a food crop, although it\'s not used in a lot of
foods, but, flax is primarily grown in the north because it handles
short day lengths. If you were to grow flax in Arkansas there\'s not
another flax field as far as one can drive in a day. So, this is a food
crop. I mean, you could design things. We can\'t be exclusive. You could
design and people are looking at that.

MS. TUCKER FOREMAN: You want to say major food crops?

DR. CRAMER: I mean, rice is a major food crop and it\'s grown in like
not very many states so if you were to grow rice in Minnesota \--

MS. TUCKER FOREMAN: They grow rice in Minnesota. They have rice in
Minnesota.

DR. SHURDUT: I do think that you have to keep it open though. I mean, I
agree you can\'t shut the door on this; that I think the topic sentence
is way too strong because of the concern, current and in the future. I
think we\'re talking about future fears, perception, the acreage out
there, there\'s no major concern now. So, again, I\'m not having
heartburn over the topic sentence. I can live with it, but, to shut the
door on use of food crops.

MR. JAFFE: I guess that\'s where I\'m confused about this. I\'m
confused. I understand what Brad says and his concern with the topic
sentence, but, for the rest of the text, I mean, where we have the some
say this, the some say that, I\'m not sure where people\'s concerns are,
what\'s the specific language.

DR. SHURDUT: You can comment.

MR. JAFFE: I think we all agreed to do that.

DR. LAYTON: Can we see where we are?

MR. JAFFE: Yeah. I really think we \--

DR. LAYTON: Let\'s go back and see where the language stands as it is
right now because I\'m lost. Total language that we have right now. Can
you accept all the changes and show me what we\'ve got?

DR. VAN EENENNAAM: Go up and look at the topic sentence. Go up four
sentences.

DR. LAYTON: Start at the beginning. Okay. And right now we have,
"There\'s a major concern that food crops genetically engineered to
produce medical or industrial products never intended for food or feed
use will inadvertently end up in a food or feed product."

Now it reads, "New genetically engineered organisms designed for medical
and industrial markets could offer substantial help and economic
benefit. There are a number of new products under active development in
these categories and the majority of those being produced in plants have
been engineered for production in important food crops.

The regulatory system for genetically engineered crops that produce a
non-food product must ensure appropriate containment, address safety
considerations, and ensure the integrity of the food and feed system.
Some food processors and consumers believe it is unlikely that any
regulatory process or containment system can ensure these products will
likely \-- will not enter the food supply.

Even if the products are safe, most consumers do not want them n their
food and are likely to respond negatively to their unexpected,
unintended presence. As a result, processors, retailers, and consumers
believe the Federal Government should not approve the use of food crops
for the production of pharmaceutical and industrial substances." And
there I think might be medical.

"Food processors and retailers fear the loss of brand value if such an
event occurs. Some committee members believe that the federal
regulations need to acknowledge that it is impossible to guarantee the
absolute absence of particular substances in commingled commodities so
that the allowances must be made for such specialty products that meet
an established standard for food safety. They also believe that the
Federal Government\'s ability to successfully address the issues of
containment and public confidence in the containment system remains
critical to the development of these products."

MR. JAFFE: And then we added the other, Randy\'s sentence: "Other
committee members believe that with adequate regulatory oversight and
appropriate industry standards the likelihood of these products entering
the food supply is remote."

DR. LAYTON: Okay. So we add a sentence that starts out with adequate
regulatory oversight \--

DR. SCHECHTMAN: Other committee members.

DR. LAYTON: Other committee members, I\'m sorry, believe that with
adequate regulation \-- adequate regulatory oversight and appropriate
industry standards, the likelihood of these products entering the food
supply is remote.

DR. SCHECHTMAN: I think that\'s \--

MR. JAFFE: No, well, I don\'t know what we did with that last sentence.

DR. LAYTON: In either case?

MR. JAFFE: No. In either case, we deleted that.

DR. SCHECHTMAN: We deleted that.

MR. JAFFE: The Federal Government\'s ability to successfully address the
issues of containment and public confidence in the containment remain
critical for the development of these products. I mean \--

DR. LAYTON: Actually, that is above. I just read that above.

MS. TUCKER FOREMAN: Yeah.

DR. LAYTON: The Federal Government\'s ability to successfully address
the issues, blah, blah, blah, that\'s right above other committee
members feel.

MR. JAFFE: Well, if that goes anywhere it should go after the brand new
sentence. I mean, it\'s a concluding sort of statement. But, I think
that probably is where it goes.

DR. LAYTON: They also believe that?

MR. JAFFE: It was switched. People switched it from they also believe to
the Federal Government\'s ability.

DR. LAYTON: Okay. Cut this whole sentence. They also. Cut that down to
product. Move it to the bottom and take they also and make it the
Federal Government.

MR. JAFFE: That\'s probably a statement everybody can agree to is the
fact that with all these different points of view and the Federal
Government clearly has to \--

DR. LAYTON: I think \--

MR. JAFFE: \-- step in.

DR. VAN EENENNAAM: Delete forward.

DR. LAYTON: Take out what you just did. Take out the \"t\" and believe
in that and the next little \"t\". The Federal Government\'s ability to
successfully address the issues of containment and public confidence in
that containment system remains critical for the development of these
products. Full stop. That\'s the end of it.

MS. DILLEY: So, we have both a mix of what committee members think and
then we also have kind of declarative statements.

MS. TUCKER FOREMAN: I think we have to go back up to where it says food
processors and consumers and make that some people \-- some members of
the committee \--

MS. DILLEY: Some members, yeah.

MS. TUCKER FOREMAN: \-- believe that it is.

MS. DILLEY: Rather than.

MS. TUCKER FOREMAN: And since it\'s some members of the committee I
would like to go back to it\'s unlikely that any regulatory processor
containment system can assure that products will never enter the food
supply.

DR. LAYTON: Okay. Then as a result processors, retailers, and consumers?

MS. TUCKER FOREMAN: As a result, some of these members, these committee
members. I\'m trying to make this consistent.

MS. DILLEY: Yeah, yeah, shift it over to committee members think as
opposed to, yeah.

DR. LAYTON: Members believe that the Federal Government should not
include the use, blah, blah, blah, okay. Then there\'s another food
processor here.

MS. TUCKER FOREMAN: Well, that\'s more an explanatory thing about why
and I just think we may just want to drop that, just drop that sentence.

MS. DILLEY: Take it out.

DR. LAYTON: Food processors\' going to come out?

MS. TUCKER FOREMAN: No, I don\'t want it out, but I\'m trying to be
unhappy.

MS. DILLEY: Tongue-in-cheek. Generously so noted.

(Discussion off the record)

DR. LAYTON: Okay. I have a question. Are these the same committee
members as the first set of committee members?

MS. TUCKER FOREMAN: Other committee members, yes.

DR. LAYTON: These committee members then instead of some.

MS. TUCKER FOREMAN: Or you might just say one group of committee members
and then a second group and then a third group in order to make it
clear.

MR. CORZINE: We have three groups?

MS. DILLEY: I think what you\'ve got is kind of a diverse perspective in
terms of \--

DR. LAYTON: Okay. Where did the first group stop, Carol? That\'s what I
need to know.

DR. VAN EENENNAAM: You\'ve got it right. Because Carol\'s group doesn\'t
think that there should be an adventitious presence allowed.

DR. LAYTON: Okay. Put a paragraph up here. Make that a paragraph. Then
other members is a paragraph.

MS. TUCKER FOREMAN: I think it works better if you have \--

DR. LAYTON: Then go down \--

MS. TUCKER FOREMAN: \-- one group, a second group, and a third group
because there\'s a lot of somes in there.

DR. LAYTON: Okay. So, the first group says.

MS. DILLEY: Okay. First group. Let\'s try and get this down to some
group.

DR. LAYTON: The first group of committee members believe that it is. How
about that?

MS. TUCKER FOREMAN: It is unlikely that any regulatory process.

DR. LAYTON: We got it. Hang on a minute, Carol. One group of committee
members believes it is unlikely blah, blah, blah. Okay. We got that.
Does that look all right?

MS. ZANNONI: I would take the second sentence out and just say the first
and third.

DR. LAYTON: Even if these products.

MS. TUCKER FOREMAN: No.

MS. ZANNONI: Because the other ones are basically if they get into the
system and what to do so the second sentence doesn\'t make it equal for
what the three things are looking at. It\'s an extra sentence.

DR. DYKES: What are the three can\'t?

DR. LAYTON: That\'s what I\'m trying to figure out.

MS. ZANNONI: That\'s what we\'re doing.

DR. LAYTON: So, the first group is no regulatory food processor
containment system is going to work, okay. The second group acknowledges
an impossible guarantee that allow for such specialty products to meet a
standard for food safety and then the third group says \--

UNIDENTIFIED MALE: How is that different from number one?

MS. TUCKER FOREMAN: We would not approve it.

DR. LAYTON: They would never approve it. This says set up some standards
so you could approve it.

MR. GIROUX: That\'s impossible.

MS. DILLEY: Okay. So nobody really advocates for that, is that what
you\'re saying? So there\'s only some and others. Is that what you\'re
saying?

MS. TUCKER FOREMAN: Aren\'t there three groups?

MR. GIROUX: I think there\'s three. There\'s not never.

MS. TUCKER FOREMAN: Yeah.

DR. LAYTON: Group number one.

MR. GIROUX: They may have set up standards to deal with it and third is
that you \--

MS. DILLEY: You can\'t do it.

MR. GIROUX: \-- you can do it with standards.

MS. TUCKER FOREMAN: I think you\'re right.

MS. DILLEY: Okay.

DR. LAYTON: Okay. So, let\'s read this over.

MR. GIROUX: And the second one is it says you can\'t do a hundred
percent so set up standards but the third one says you can do a hundred
percent if these standards are appropriate.

DR. DYKES: And the first one was what, I don\'t want them regardless of
whether you can do it or not?

MS. DILLEY: Right.

MR. GIROUX: The first one is you can\'t do it ever. The second one is
you need an AP safety term. The other one is yes you can if the
standards are right.

DR. VAN EENENNAAM: What standards?

MS. DILLEY: That\'s how you end up with some others.

MR. GIROUX: Regulatory containment standards.

MR. CORZINE: I still don\'t know that I buy that middle group because
even the third group, it says remote. The word remote is in there and
I\'m not sure that that is different from the second group.

MR. GIROUX: Converge the two, I think.

MS. DILLEY: I think it\'s increasing confidence in the regulatory system
or other systems to keep things where they need to be.

MR. SHURDUT: What I\'m saying is I think that what the third group is
saying and what that says is inclusive of the second group because
you\'ve got that word remote. It\'s saying it is remote.

DR. SCHECHTMAN: Maybe what that implies is that the thing to do is to
make that sentence about with adequate regulatory oversight the first
sentence of the description of the second group, if that makes sense.
Some people think you can\'t do it. Other members believe that with
adequate regulatory oversight the likelihood is remote and then go on
and talk about the rest of what group two believed.

MS. DILLEY: And you set up standards to do that.

MR. SHURDUT: What else is there?

DR. SCHECHTMAN: That federal regulations need to acknowledge that it\'s
impossible to guarantee and that \--

MR. SHURDUT: Well, that\'s for everybody. I mean, that\'s kind of a
closing line, right?

DR. SCHECHTMAN: Yes.

MR. SHURDUT: So, that\'s sort of we do have the two groups now. Is that
right? Is that \--

MR. CORZINE: I think you could say that you could put in a regulatory
system that\'s appropriate when you\'re going to have the top level of
containment. You know, you can go into, you know, the desert or
something. That\'s different from then accepting that there\'s a
tolerance system that you need to put in place.

DR. LAYTON: And the middle group is tolerance.

MR. CORZINE: And the middle group is for tolerance.

MS. DILLEY: So it is three different perspectives. So, let\'s just make
sure we\'ve got them.

DR. SHURDUT: I think that\'s what the last group is saying.

MR. CORZINE: It\'s saying you can contain it.

(Discussion off the record)

MR. CORZINE: Then what you\'re saying then is the third group, and
that\'s fine, Brad, I don\'t completely disagree with you but you take
out the word remote because you\'re saying an absolute. So, get that
word remote out of there.

MS. DILLEY: Remove remote.

MR. CORZINE: Remove remote. Entering the food supply period.

DR. VAN EENENNAAM: These products will not enter the food supply.

MR. CORZINE: Period.

MS. DILLEY: These products will not enter the food supply.

MR. CORZINE: And instead of the likelihood you put in will not enter.
Industry standards will prevent these products from entering the food
supply.

MS. DILLEY: Right. That\'s the third group. That\'s right.

DR. DYKES: I do think that it is a valid point. I\'m sure that we have
people in all the groups we are identifying here. We\'re identifying
three groups. I\'m not sure we\'ve got \--

DR. SCHECHTMAN: Well, someone did suggest that sentence though.

DR. HUNT: What\'s the second group saying now? I got very confused over
this food process thing.

MS. DILLEY: So you\'ve got the no, not never, and you\'ve got the \--
even if you set up a regulatory system you\'re still going to have
things ending up where they may be shouldn\'t be but you can set up
tolerances, standards, procedures to address them.

DR. HUNT: In that section I would like to see something about
containment and also food safety, whether we captured that.

DR. LAYTON: Is there a group \-- are there people who are proposing the
middle group, the tolerances?

UNIDENTIFIED MALE: Yeah, absolutely.

MS. DILLEY: Yes, because there are people saying that you can address
safety issues by recognizing that you can never have a hundred percent
foolproof system. There are ways to deal with it. Also, there are tools
you just mentioned that can address food safety. We can elaborate on
that. Then there\'s a last group that says you can set up a regulatory
system that doesn\'t require some additional tools.

DR. SCHECHTMAN: That\'s good enough by itself.

MS. DILLEY: That\'s good enough by itself, right? Maybe there\'s not
anybody in the last group. Brad, I thought you were articulating the
last perspective?

DR. SHURDUT: Again, I might as well \-- \-- the last group.

DR. SCHECHTMAN: Can we have one conversation, please.

DR. SHURDUT: But, there is the likelihood of if you did it in a
greenhouse, or you did it in a desert, and remote area or you do flax in
a region. There are areas you can envision where you are going to have,
you know, a hundred percent containment.

DR. LAYTON: Take out the with.

DR. SHURDUT: I mean, there\'s cell technology going on.

MS. DILLEY: I just want to understand. I don\'t think the people
disagree that there are scenarios where you could do a hundred percent
containment, but, is that going to be adequate to say you always will
have containment. I think that\'s what I\'m trying to understand if
there\'s a difference.

MR. CORZINE: New paragraph. There you go.

DR. LAYTON: And entering the food supply.

DR. SHURDUT: It depends on how far the regulation is driving.

MS. DILLEY: Carole?

DR. CRAMER: I\'m a small company. I\'m a company who wants to go forward
with a plant-made pharmaceutical and I am not going to go forward in a
way that\'s sloppy that ends up in the food supply. I think that it\'s
challenging. I think that the industry is aware of those issues. I think
the USDA and FDA are aware of those issues and I think that people are
going to be crazy to go in and do it in something that does not have
such a level of redundancy of containment in that they don\'t have an
understanding of the impacts of their transgene.

I mean, I feel strongly that people are becoming extremely creative in
recognizing the consumer and

industry \--

MS. DILLEY: I don\'t know if that changes that we have two or three
groups.

DR. CRAMER: I like the three groups.

MS. DILLEY: You do like the third group?

DR. CRAMER: Yes.

MS. DILLEY: So, let\'s just make sure we\'ve got the right language for
each of those three groups then.

MS. TUCKER FOREMAN: One group of members.

DR. SCHECHTMAN: Believes.

MS. DILLEY: One group of committee members believe that it is unlikely
that any regulatory process or containment system can assure that these
products will never enter the food supply. Even if the products are safe
\-- shouldn\'t that be these members do not want them in \-- don\'t you
continue the some members?

DR. SHURDUT: Yes, you did.

MS. TUCKER FOREMAN: Yes, yes.

MS. DILLEY: So, it says even if these products are safe these members
believe most consumers do not want them in their food and are likely to
respond negatively to their unexpected unintended presence. Then we take
out the next sentence, as a result, blah, blah, blah.

MS. TUCKER FOREMAN: No. These members believe the Federal Government
should not \--

DR. LAYTON: Should not approve the use of food crops.

MS. ZANNONI: But, I don\'t think the second sentence equates with the
other two.

DR. LAYTON: I agree.

MS. ZANNONI: So, I think you need to make them all even where everybody
has a sentence that kind of publicizes \--

DR. HUNT: Justifies their rationale.

DR. LAYTON: Can you read it with \-- did you look at it, Carol, if she
just deletes that second sentence for a moment and see how you feel
about it.

MS. DILLEY: Well, you\'ve got to look at it in the whole because I think
your rationale for taking it out is balance for all three groups.

DR. LAYTON: Okay. Let\'s look at it now for balance. One group of
committee members believes it\'s unlikely that any regulatory process or
containment system can assure that these products will never enter the
food system \-- food supply. As a result, these committee members
believe that the Federal Government should not approve the use of food
crops for the production of pharmaceutical and industrial substances.

MS. TUCKER FOREMAN: I think you have to say \--

MS. DILLEY: Medical and \--

MS. TUCKER FOREMAN: Wait, wait, wait.

MS. DILLEY: \-- industrial.

MS. TUCKER FOREMAN: You want to read through the rest of it?

DR. LAYTON: I want to read through the rest of it and make sure we\'re
balanced. Other members believe that federal regulations need to
acknowledge it is impossible to guarantee the absolute absence of
particular substances in commingled commodities so that allowances must
be made for such specialty products \--

MS. TUCKER FOREMAN: Not specialty products.

DR. SCHECHTMAN: Such products when they meet.

DR. LAYTON: When they meet an established standard for food safety.
Still other committee members \--

DR. SHURDUT: Shouldn\'t it say another group of?

DR. LAYTON: Another group of committee members believe that adequate
regulatory oversight and appropriate industry standards will prevent
these products from entering the food supply.

And then finally the wrap up sentence is the Federal Government\'s
ability to successfully address the issues of containment and public
confidence in that containment system remains critical for the
development of these products.

MS. TUCKER FOREMAN: I would say, first of all, that that last sentence
really goes to the interests and concerns of groups two and three
because you\'re assuming that the Federal Government can in fact do it
and that sentence reinforces your view.

I would suggest that you say after enter the food supply \--

DR. SCHECHTMAN: Where?

MS. TUCKER FOREMAN: If you say any regulatory process or containment
system can assure these products will never enter the food supply
period. These members

believe \--

DR. SCHECHTMAN: Going back up to \--

MS. TUCKER FOREMAN: Yeah, I\'m sorry. These members believe consumers do
not want these products \-- even if these products are safe, most
consumers do not want them in their food and you can cut it off right
there.

DR. CRAMER: So that was the sentence that was there in the middle of the
page, right?

MS. TUCKER FOREMAN: I just cut it in half. And my argument is that the
last sentence reinforces the positions of groups two and three because
it actually says that the Feds can do it and we don\'t believe they can.

DR. CRAMER: But the decision of the Feds might be that it can\'t be done
fully approved properly.

DR. VAN EENENNAAM: Take that out. It\'s the one that you deleted a
little while ago.

MS. DILLEY: So you\'re for delete that and the \--

MS. TUCKER FOREMAN: Well, you know, I\'m back now to this thing. If
we\'re going to have some members do this and some do that.

MS. DILLEY: I think your point\'s taken. It\'s just a question of
evenness in each of these so there\'s an extension of the some numbers.
Okay. It\'s not. Go ahead, Carole.

DR. CRAMER: I don\'t have a problem. Let her put back the sentence in
its form. I don\'t think that that\'s a problem.

MS. DILLEY: Well, other people I think do have a problem.

MS. ZANNONI: I would just take out the last sentence then.

MS. DILLEY: Okay.

DR. SCHECHTMAN: So you\'re taking out the as a result of government
shouldn\'t?

MS. TUCKER FOREMAN: No, I\'m not taking that out.

DR. SCHECHTMAN: I\'m sorry, I didn\'t understand.

MS. TUCKER FOREMAN: My suggestion is that you, again, where it has never
entered the food supply, these members believe consumers do not want
these products in their food. Even if the products are safe, consumers
do not want them in their food supply period. There has to be a reason
why we say that it should never be there.

The others are saying you don\'t quarrel with the fact that consumers
don\'t want them in the food supply in one case and, but, they don\'t
know. You\'re arguing that you don\'t care if it\'s \-- and you can put
that in if you want.

The second group believes that consumers won\'t care if it\'s a minor
amount.

DR. LAYTON: Would you read it and see if it says what you want it to
say?

MS. TUCKER FOREMAN: I\'m sorry, I have to stand up.

MS. DILLEY: It\'s hard to see.

MS. TUCKER FOREMAN: I would say these members believe that consumers \--
the belief that even if these products are safe consumers do not want
them in their food supply. And we can take out as a result if you want
to, but, it doesn\'t make any difference.

MS. DILLEY: Should we take out that last sentence?

DR. LAYTON: These members believe that even if these products are safe
consumers do not want them in their food supply. So take out the second
products?

MS. TUCKER FOREMAN: No. Yeah. You leave that next sentence in there.

DR. LAYTON: Take that word out. Consumers do not want them in their food
supply.

MS. TUCKER FOREMAN: Right. In their food period.

DR. LAYTON: Food period.

MS. TUCKER FOREMAN: As a result, some committee members believe that the
Federal Government should not approve the use of food crops for the
production \--

MS. DILLEY: Can you just say and believe the Federal Government?

MS. TUCKER FOREMAN: That\'s fine.

MS. DILLEY: Okay. Josephine?

DR. HUNT: I think for all three groups we can all agree that consumers
don\'t want these products.

MS. TUCKER FOREMAN: I\'m sorry, I can\'t hear you.

DR. HUNT: For all three groups we can agree that consumers wouldn\'t
want such products to end up in the finished food product.

MS. TUCKER FOREMAN: Then put it up in the sentence above.

DR. VAN EENENNAAM: I think it depends on the product. I don\'t know that
some products wouldn\'t worry me in the slightest if they were in there.

MS. TUCKER FOREMAN: You\'re not a typical consumer.

DR. HUNT: Well, consumers generally.

DR. CRAMER: I think you increased that.

DR. HUNT: Then we disagree.

MS. DILLEY: We are talking about medical and industrial products so I
don\'t know if that goes to your point, Josephine, of those consumers
wouldn\'t want medical and industrial products in their food supply.

DR. HUNT: Well, it\'s a conflict.

MS. DILLEY: Other things \-- Alison, you\'re right. Maybe it\'s not \--
I don\'t know if that\'s what \-- why

you\'re \--

MR. GRANT: Leave the words out. It\'s going to \-- it changes it too
much if you put it up on top. I mean, the dose makes the poison issue.

DR. HUNT: It\'s not intended to be food in the first place.

MS. DILLEY: Right. Go to the next section. Wait. Carol\'s happy, right?

MR. KREMER: While we\'re on that, I\'m a little uncomfortable with the
sentence that says even if these products are safe. Carol, I think I\'m
part of that group. I feel that the consumers don\'t feel things are
necessarily safe. I\'d like to see it change to either is safe, or,
considered, or, claimed to be safe, or, something like that. MS. TUCKER
FOREMAN: Food safe. Sounds to me like a good improvement.

MR. KREMER: It might be a minor technicality, but, the reason why I
think those consumers don\'t want them in the food is because they
don\'t feel they\'re safe, they don\'t think the same.

MS. TUCKER FOREMAN: I think that\'s a good point.

DR. LAYTON: Okay. So you\'re comfortable that?

MR. KREMER: I am.

DR. LAYTON: Okay. Josephine is not.

DR. HUNT: Well, I\'m going back now \-- you all are going to hate me \--
to the very original text because that\'s what I read. And that was when
we were talking about food producers and consumers and I have some
issues with the way the position for the food processes are being put
forward. Now we\'ve got rid of the word food processors and consumers. I
see it in some way that we\'re almost falling between groups one and
two, if you see what I mean.

So, we\'ve now got three groups where I\'m feeling we\'re not really
fully belonging to one or two. We\'re somewhere in the middle of it. So,
I\'d hate to make a fourth group.

MS. TUCKER FOREMAN: Add that consumers don\'t want them in their food as
a general sentence.

DR. HUNT: If we look here, we talk about some committee members feel
it\'s unlikely, blah, blah, blah, and then this last sentence, as a
result these committee members believe that the Federal Government
should not approve the use of food crops in the production of medical
and industrial substances.

Now, originally, when we talked about instead of one group of committee
members it was food producers and consumers. That wasn\'t entirely true
for the food processors. I think what we\'re saying is food processors
is ideally we wouldn\'t want these products to be in food crops.
However, if there was the right kind of regulatory process in place, for
example, safety and, for example, containment, then we\'re not saying it
should not be.

MS. TUCKER FOREMAN: May I try something then? If you say will never
enter the food supply then are we agreed that consumers \-- you want to
say food processors and consumers don\'t want them in their food or
don\'t want \--

DR. HUNT: I\'m fine up to that point.

MS. TUCKER FOREMAN: Let me try this. Don\'t want an intended,
unexpected, or, unintended products in their food and then you go as a
result, but, not as a result, but, then you say some members think the
answer is ban them in food products.

Some members think, and you might want to expand that, your rationale
for being in position two, and then go to three?

DR. HUNT: Well, essentially, I mean, I know it\'s changed a lot since
the original text, but, that last sentence there would then split into
two. While we can all agree that consumers don\'t want these in their
food products, one camp may say, therefore, you should never have it in
food, developing food crops, but, another camp says under certain
conditions it\'s ideally never in food crops, but, acknowledging that
sometimes it may make sense the only way forward that we have systems
such as containment and food safety assessments in place.

MR. OLSON: So, there are four at the end of that?

DR. HUNT: I\'m not quite sure how the language should be.

MR. JAFFE: I think you can just say \-- I think where that second group
is just change it a little bit to work directly into that.

MS. TUCKER FOREMAN: I thought Josephine had some good language there.

DR. HUNT: I have no idea what I said.

MS. DILLEY: You\'re placing the emphasis on \-- well, everybody can
agree people don\'t want these \-- consumers don\'t want them to show up
in the food supply and then the difference of opinion is whether or not
\--

UNIDENTIFIED FEMALE: How you deal with it.

MS. DILLEY: Yeah. How effective the tools are to make sure that that
happens.

DR. SCHECHTMAN: Could you move down to number 2.

DR. HUNT: Maybe then we could squeeze it into the three groups.

DR. SCHECHTMAN: Could you move down to group two for a second.

MS. DILLEY: Right.

DR. SCHECHTMAN: I mean, you could start group two with other members
acknowledge that consumers have concerns, but, believe, you know,
something along those lines.

MS. DILLEY: But, that\'s not part of what she\'s saying. I think it\'s
moving the consumer \-- you don\'t want it to end up in the \--
everybody\'s agreeing that the ideal situation is that these products
don\'t end up into the food supply. But, the best approach to ensure
that is where people have different points of view. Some people say
therefore you never grow it in food crops. Other people say you can grow
it in food crops as long as you have the right containment tools and
still others \--

DR. HUNT: Others are between two as well. You know, saying ideally not
in food crops. However, if so, then safety assessments and containments.

MS. DILLEY: Then there really are only two groups, I think.

DR. HUNT: No, no. There\'s a third group. They\'re saying, I believe,
that the systems are okay as they are. Is that right?

DR. CRAMER: They\'re saying if one could design a system you could \--

MS. DILLEY: Without any additional tools?

DR. HUNT: A hundred percent containment?

MS. TUCKER FOREMAN: Maybe that shouldn\'t be in places where we never
intended them to be.

MR. CORZINE: What I wonder, Alison, where I am is I don\'t think we
should say that there is only one group that has consumer concerns.

MS. DILLEY: No, I think everybody\'s interested in not \--

MR. CORZINE: Yeah, now how we word that, but, maybe if you\'re going to
have something about consumer concerns in group one you should have that
also in group two and maybe also in group three because I think
everybody \-- there\'s not an exclusive right to consumer concerns in
any one group.

MS. TUCKER FOREMAN: I think that Josephine really addressed by having
the \-- whereas we all agree that consumers don\'t want these substances
in their food, but, disagree about \-- we disagree about the actions
that arise from that. One group believes you never approve them, one
group believes that with appropriate safety measures that you can or
that you should \-- that it probably will happen, but, it\'s fair to say
it\'s not a problem and the third group believes it\'s fine, that you
can have a system that works and never lets them get there. I think your
approach by having \-- I think you\'re right, Leon.

If you put consumers up in that given part and you have them \-- then
you can have \-- we disagree about

having \--

DR. CRAMER: So, right before the regulatory system we can insert a
sentence that says something like it\'s recognized that, you know, most
food processors and consumers are not \-- would not want unexpected and
unintended things even though I wouldn\'t care if there\'s an antibody
in it. I don\'t want surprises.

DR. SLUTSKY: Can someone explain to me what the three groups are?
Because, when I listen to you all, it seems like there\'s only two
groups.

MR. JAFFE: I\'ll be happy to do it. The one group \-- I look at it this
way. One group is saying no, don\'t, never do this in food crops.
That\'s one group saying they can\'t be contained, never do them in food
crops. Moratorium group let\'s call it. Moratorium group.

There\'s one group that\'s saying we can contain them. Do them in food
crops. We can contain them. They will never get in the food supply.
That\'s their honest view. The middle group, I\'ll call it the practical
group. They would prefer it never be grown in food crops. But, the
reality is that they know that they can\'t get that so they want to make
sure that there are safeguards in place so that when they get \-- if and
when they get into food crops and there\'s a liability thing, whatever,
there\'s some tolerances. The regulatory system is set up to address
that fact. It\'s not fitting into either of those camps.

DR. SLUTSKY: Okay. But, can I just ask, how come the third group is the
gung ho group. If the third group \-- is there really a third group, and
there might be, I just want to hear you guys discuss it. I\'m not sure
that there is. Is there a third group that says, okay, yeah, we want to
put these in food crops and we think everything is in place? So, I just
\--

MR. JAFFE: It may not be in place now, but, they say it can be in place.

DR. SHURDUT: No, no, no. I think there\'s sort of a hybrid thing here.
I\'ve kind of thought through this again. I thought number two was that
on issue you build sort of an AP strategy. You grow a big industrial
ethanol crop. Gets in the food supply so you kind of expect it to get
out there. The way we\'re talking about it now is that we go out and the
initial thing we do is put a containment strategy system in place. The
risk management piece is if you can\'t manage it then you have food
safety behind it.

I think two and three are blurred together because I do think those,
even those things that in certain cases you can contain it a hundred
percent, if there\'s that potential risk there\'s also that need to sort
of have that risk management tool, that being an AP type food safety
system. So, two and three do blur together. It\'s how you articulate it.

I think the goal is to get that hundred percent containment and then to
have that AP fall back as a risk management opportunity.

MS. TUCKER FOREMAN: Would you agree with that, Josephine?

DR. HUNT: Yeah. I\'m just thinking about like in terms of having AP for
pharmaceutical products.

DR. SHURDUT: It\'s a bad term and I used a bad precedent.

DR. HUNT: Because, you know, if it\'s not intended to be food it
shouldn\'t be \--

DR. SHURDUT: But, some kind of food approval.

MS. DILLEY: Randy?

MR. GIROUX: It blurs two issues though. PMP\'s are a marketing issue and
potentially a food safety issue. And if you don\'t separate the
marketing issues which are where food processors and the branded food
companies are and then there\'s safety issues that may involve
containment or some \-- those two issues get blurred together when you
blur the food safety issues and the risk management strategies with the
\-- if it\'s ever found in my branded food product I got a big problem.

If you blur those two issues together, that\'s why this is such a
confusing issue because there\'s, from a marketing perspective, some
people feel one way. From a food safety regulatory perspective, people
may feel the other. But, if you\'re both, you\'re stuck in the middle
with both.

MS. TUCKER FOREMAN: That\'s why risk managers get old early.

MR. GIROUX: So, it\'s a very complicated issue and I think that\'s why
we\'re struggling so much is we\'re trying to come up with \-- we\'re
trying to describe it from a food safety, risk management perspective,
and from a marketing perspective in the same bucket.

MS. TUCKER FOREMAN: That\'s what I was trying to do with the \--

MR. GIROUX: Number two would be more of a risk management group, not
addressed to marketing issues. Those are for the food industry to deal
with and for the consumer the market will take care of that. It
theoretically takes care of that. And then from a regulatory
perspective, from a food safety perspective, science-based risk
management approach, is that the correct approach. And I think with this
issue it\'s so hard to tear those apart but this is a common
argument/discussion all the time.

MS. ZANNONI: Well, and it\'s not just the safety and marketing, but, all
these products aren\'t equal.

MR. GIROUX: Right.

MS. ZANNONI: And so some you can get a safety assessment for food and
feed which is one thing and some you will never, ever get that and, so,
you need to be careful like we\'re not hindering the ones that have
better going for food and feed safety regulatory procedures with the
ones that strictly should never, ever see \-- get into food.

DR. LAYTON: And some are specifically talking about in the food world.

MS. ZANNONI: No, it\'s the pharmaceutical and the industrial.

MR. JAFFE: The second group. And there\'s a sentence in there that they
acknowledge the fact that although you\'re talking containment there\'s
a chance that these things will eventually get in the food supply and,
therefore, we need regulatory mechanisms to deal with that. The third
group says they don\'t acknowledge that you can get it \-- will
eventually get into food supply.

Carol\'s described it as saying maybe by containing it there\'s no need
for those things because there\'s ways you can contain it and won\'t get
in the food supply long-term.

MS. DILLEY: But, I think it goes back to Randy saying it\'s more
marketing and safety issues. That\'s why I\'m not so sure. I mean, two
things. One, you had your card up and then Carole and then we are at the
point where we have to take a break here before public comment and I
guess let\'s take the comments but we also need a way \-- obviously
it\'s very complicated because we\'ve just spent almost two hours on
this topic in trying to \-- and I think we made a lot of progress on it
and we need to resolve it so we can move on to other topics.

So, if people can suggest ways to move us forward, that would be
helpful. Ron and then Carole.

MR. OLSON: I\'ll just make a minor suggestion. Make group number two
group number three. You have a total don\'t put it in food crops. You
have a group that says, okay, we can do it in food crops under the right
conditions, and then group three is what if group two fails and some
gets out, then we need a tolerance.

DR. CRAMER: Mine is sort of the same which is, I think that if we
rethink the way we phrased it we could possibly put two and three
together which is to say something along the line that other committee
members believe that there are mechanisms to manage all the risks that
would involve containment, use of non-food crops.

MS. TUCKER FOREMAN: You\'re referencing only food crops.

DR. CRAMER: Tolerances.

MS. TUCKER FOREMAN: You can\'t say non-food crops because you already
said the problem is food crops.

MS. DILLEY: Okay. Maybe when we come back I think we need to go with
Ron\'s formulation and maybe that gets us to where we need to go which
is, you know, don\'t do it; do it, we can contain it; and the third
group is really if you move forward and containment doesn\'t work you
need a backup system that doesn\'t completely wreck the marketplace, I
guess.

MS. TUCKER FOREMAN: But, in all cases we are only talking about getting
it in food products.

MS. DILLEY: Right.

MS. TUCKER FOREMAN: You can go out and grow tobacco until the cows come
home, that\'s fine, but, \--

MR. CORZINE: Can we, as we do that, then maybe we look at whether we can
meld them together and then the other thing we should look at, I think
we need to make sure that because there\'s not an exclusive on the
consumer concerns and whether we can soften or change that consumer
language to where it is to all.

MS. DILLEY: I think we have already made that leap. That Josephine has
said \-- no? I thought we did agree that there was language that goes to
the consumer point of view, goes to all, everybody. All right. We need
to come up with the language to make sure it\'s there and that we\'ve
got the formulation that Ron has.

DR. LAYTON: Why don\'t we take 15 minutes? Abby and Cindy work on that.

(Whereupon, a brief recess was taken)

DR. LAYTON: If we can get everyone seated. We have a public commentor.
Can I have your name, please?

MR. HENSLEY: Yeah. My name is William Hensley. I\'m with Bayer Crop
Science.

DR. LAYTON: William?

MR. HENSLEY: Hensley \-- H-E-N-S-L-E-Y.

DR. LAYTON: H-E-N-S-L-E-Y.

DR. SCHECHTMAN: Why don\'t we let you do this in the microphone so that
it can get on. Come up to the table.

MR. HENSLEY: Hello. My name is William Hensley. I\'m with Bayer Crop
Science, the public relations office here in Washington, D.C.

DR. LAYTON: Wait. I want to make sure people hear you. Okay.

MR. HENSLEY: Great. First of all, I just want to say thank you all for
this great dialogue today. It\'s been very interesting and informative
and appreciate everyone\'s effort here. And since we just got off of
14-A, I just want to make one brief comment on the dialogue on that
topic. And there was a brief discussion about it earlier in one of the
opening sentences, the discussion about benefits and how there could
potentially be substantial economic and health benefits to the
development of these technologies.

And I think that in any discussion about the potential for this
technology under the context of providing the Secretary with information
about where biotechnology is going in the next ten years I think it\'s
incredibly important to frame this whole debate with all of these very
different perspectives which many people are obviously very passionate
about under the context of where those benefits could potentially go.

So, I just think that it would be important to flesh that out just a
little bit so that the Secretary, when reading this document, is very
much understanding of why everyone is so passionate about it, why there
are so many different views, because potentially in the long term it
could offer these very substantial benefits. So, that\'s just one
comment on the discussion about point 14.

And now I want to jump over to point 10.5. Just briefly, and this was
raised as well by a couple of folks, and I just want to reinforce it and
that\'s when you\'re talking about the need for these international
approaches to adventitious presence oftentimes, and it was very clear
that no single country can provide one solution to this. However, I do
think that it is important for the United States to be the leader in
that discussion internationally.

And as the panel talked about somewhat disparaging these individual
countries moving forward, there was some commentary on how the United
States in turn could say, well, what does it matter if we develop our
own policy. And I think that it would be important in that context of
10.5 to make it very clear, especially the United States unilateral
policy on adventitious presence is an important step in moving forward
with the international piece and making sure that international
countries then have a framework to look at and move forward with.

So, and I think that it could potentially be very possible that U.S.
agencies could look at these comments and say, well, you know, the
stakeholder position and the stakeholder recommendations said that it
doesn\'t matter and I just think that\'s potentially very dangerous and
I think it needs to be very clear that the United States is the leader
internationally and that their unilateral policy is an important one.

And those are my two comments. Again, thank everyone, I thank everyone
for their work and comments to it.

DR. LAYTON: Thank you very much and if you will provide us a written
statement that would be wonderful because it does go in the record.

MR. HENSLEY: I certainly will. Great.

DR. LAYTON: Any other public comments? With that, I will then return the
agenda to Abby.

MS. DILLEY: So, we\'re close but we\'re not quite there.

DR. LAYTON: Can you tell us which one we\'re going to next and some of
us could begin reading the next one?

MS. DILLEY: Oh, I see, you don\'t want to keep talking about \-- do you
want those people \--

DR. LAYTON: You said you were going \-- you needed a few minutes. I
thought we\'d continue where you were.

MS. DILLEY: Do you want to do some editing up here and then come back to
the group or not while people read the next topic or what do you want to
do?

MS. TUCKER FOREMAN: I have a suggestion.

DR. SCHECHTMAN: Closer to the microphone please.

MS. TUCKER FOREMAN: I was really going to suggest that we go over there
while you all start on the next one. Because then we come back and \--

MS. DILLEY: I was going to suggest we tackle transparency, number 16.

DR. LAYTON: Number 16, transparency in the regulatory system.

MS. DILLEY: So, that\'s on page 16 of the document that Pat circulated,
the version for editing, at the January plenary and it\'s on page \-- it
starts on page 12 on the colorful draft, if you will. And, so, while
you\'re reviewing \-- people are reviewing this, Josephine, Ron, and
Carol, I think we were trying to work out language up here on 14.

The process was \-- I guess I had a question. You guys want to wait and
see if they can get there in a couple of minutes or do you want to jump
into 16 and come back to 14 when they get there?

DR. SCHECHTMAN: Let\'s ask them where they are.

MS. DILLEY: How close are you guys?

MS. TUCKER FOREMAN: We\'re not.

MS. DILLEY: You\'re not. Okay. Michael, did you have a suggestion?

DR. DYKES: With regard to 16, without that group\'s participation all
that leads to is we\'ll do 16 twice.

MS. DILLEY: Twice. So, we don\'t want to do that. Okay. So, maybe \--

DR. LAYTON: Can we go back and help them?

MS. DILLEY: That\'s true. It\'s kind of hard to do 16 without everybody
talking about the topic. So, do we want to set 14 aside for now and talk
about 16 and have you guys worked on it and come back?

MS. TUCKER FOREMAN: No. We\'re going to do it at the end.

MS. DILLEY: End of today.

DR. LAYTON: At night before you leave?

MS. TUCKER FOREMAN: We\'re close.

DR. LAYTON: You\'re close?

MS. DILLEY: Well, if you\'re close do you want to keep at it?

MS. TUCKER FOREMAN: No.

MS. DILLEY: You don\'t want to do it now. Okay.

DR. SCHECHTMAN: Number 16.

MS. DILLEY: Okay. On transparency. I think it would be the same approach
would be helpful on transparency as would the other ones where we tried
to kind of break it down into what are we trying to say and how we want
to say it. We\'ve got a lot here in terms of it seems like the key that
we\'re trying to link is transparency and confidence in the safety of
genetically engineered organisms and then we start talking about \-- we
talk about why transparency is important and then we talk about the
different requirements of different federal agencies and I think one of
the things that we may end up linking is kind of the A system and
animals and PMP\'s, et cetera with everything else.

So, it gets a little mushed together and it\'s pretty lengthy so maybe
if we try and sort through what are the particular points that we\'re
trying to make and how we want to make them that might be helpful.

So, Michael, you have a comment and then Carole Cramer, is your card up?
Okay. So, Michael and then Alison.

DR. DYKES: I\'d just ask the general question in my own mind because I
looked at this. It\'s a fairly straightforward concept about
transparency is important in the regulatory process. But, it seems to me
that we ramble on and on and on about a whole bunch of stuff when I\'m
only asking the question, is it really \-- are we really trying to make
a different point or is this all about transparency? Is this all
contained \-- all the discussion here is contained to the U.S.
regulatory system?

So, I wonder if our concern we\'re trying to convey is accurately put
forward in the topic statement about transparency or is it more a desire
to have access to more information because there\'s some places it\'s
provided and other places it isn\'t. I\'m not clear that I understand as
I read this, I read this and say I\'m not sure what this group\'s trying
to tell me.

MS. DILLEY: Okay. The explanatory text is trying to \-- and, so \--

DR. DYKES: Yeah. I don\'t see that the explanatory text necessarily hits
home, transparency. Then the other fundamental thing, transparency is
not going to ensure the safety. I think we come close to trying to make
that equation in here that if it\'s more transparent it\'s more safe and
I\'m not sure in transparency about the decisions made regarding safety,
but, I don\'t know that there\'s a relationship between transparency and
safety.

And I think we\'ve come fairly close to making that connection.

MS. DILLEY: Greg? Oh, I\'m sorry, Alison.

DR. VAN EENENNAAM: I was going to say that looking at the comments on
this it was really mostly Greg\'s comments and, so, I wonder \-- and he
cut out quite a lot of stuff in his that removes some of what Michael\'s
concerned about. I\'m wondering if we should look at Greg\'s version
which is minimized relative to the one that\'s in the side-by-side and
then make comments on that one.

MR. JAFFE: I mean, responding to Michael. I don\'t think more \-- I
think you can make the argument that transparency does increase safety
because if you have transparency then you can get public participation
without transparency. If you have public participation there\'s
government information that it might not readily have which might
actually hinge on the safety determination so if there\'s a study that,
you know, or a problem with the study that a scientist points out that
can actually improve safety.

But, I don\'t think that\'s what this point. What we\'re trying to make
here is not with public participation, but, I\'m just saying that you
can\'t have public participation without transparency and I do think
that combination of those two things does lead to better decisions by
the government, in my opinion.

I\'ve been inside the government and been on the other side and know
that public comment can help make better decisions. So, but, I don\'t
think that\'s the point here. I think the point here is that
transparency does help in the confidence of those understanding the
decision the government is making.

If you don\'t have an understanding of what\'s behind that decision, you
don\'t have transparency, both in knowing what the decision is and
knowing what the regulatory process and the information that was the
basis for that decision, I think those do add to the confidence in the
system, both the U.S. and abroad.

I think that\'s what this is trying to get at. Most of my comments, I
don\'t have a problem with the sort of overall concept of the topic. In
fact, this is a very, very important topic and very near and dear to my
heart, so, it is. My concern was \-- and, so, I have a couple of
concerns. One was we took out \-- there was a sentence taken out over in
the work group and I\'m not sure why it was taken out. It was changed in
two sentences, the second and third sentence.

It\'s not a comment that I\'m going to drop my sword on. I think that
the original sentence was stronger and better where it said full
transparency requires the ability of organizations and individuals to
gain timely access, et cetera. But, if people want to stick with the
other two sentences, I think they\'re just a little less strong.

But, most of my comments relate to the second half, which was the
examples and I really felt that they were giving a wrong impression on
the realities of the system and they seem to have been written as sort
of a justification for what goes on and, so I tried to rewrite those
and, so I think accurately reflect the balance that goes on with
transparency, the exemptions, the legal requirements, and then how well
some different agencies in fact carry those out.

So, that\'s what my comments relate to, is I thought that the discussion
was not giving an accurate picture, at least a picture that I didn\'t
believe was true or that I could support and tried to rewrite it to a
more accurate portrayal of what happens with different agencies who are
doing biotech in terms of transparency for the regulatory system.

DR. DYKES: Well, I guess I\'d come back to say I\'m fine with what
Greg\'s saying. It just seems to me like we go a long way around. We
start off with saying it needs to be transparent which, I think,
everybody agrees with it. So, what are we trying to communicate relative
to transparency and can we somehow another say that in a much more
succinct manner.

Once you read it and go, okay, I now know what the issue is and where
the rub is. As I read this, it\'s a complete rendition of what happens
today with different agencies but when I read it I\'m not sure I\'m any
more informed about where the problem is or what needs to be done.

MR. JAFFE: And I guess \-- I guess my problem with what was written was
that it seemed to try to give a justification that everything is fine.
It\'s just doing the best it can. I don\'t think that\'s the case. So,
I\'m comfortable deleting all of the examples and we could have the
first three sentences and then say although \-- you know \-- although
there are places where the system is transparent, there are also places
where there could be improvement and leave it at that.

But, I felt that what was written by whoever wrote it, the previous
draft, was sort of a justification in some sense and the system\'s doing
the best it can. It\'s hamstrung by CBI and it's hamstrung by the Food
and Drug Cosmetics Act, the new animal drug provisions. And I thought
that was an inaccurate portrayal of the reality. So, I\'m comfortable
getting rid of all of those examples and putting some sentence in after
the first three.

DR. LAYTON: So, you could say each federal agency and from there on
delete it? That is line 544 on the draft for the editing today.

MR. JAFFE: No. That was the sentence where I started having problems
with.

DR. LAYTON: Okay.

MR. JAFFE: I would say \--

DR. LAYTON: From which they\'re derived period.

MR. JAFFE: No, I think they have to \-- then they would have to say
something about \-- then I would add some sentence that says although
portions of the regulatory system have done a very good job of
transparency, there\'s also areas that could be improved.

DR. LAYTON: But, you said keep the first three sentences.

DR. SCHECHTMAN: You\'re saying keep the first four sentences.

MR. JAFFE: One, two three. No.

DR. LAYTON: Transparency. In a transparency and addition.

MR. JAFFE: Right.

DR. LAYTON: Okay. So, the fourth sentence is, each federal agency.

MR. JAFFE: Right.

DR. LAYTON: So you\'re saying start with each federal agency and delete
the rest of the paragraph, the rest of the topics, the rest of the
sentences?

MR. JAFFE: I\'m saying I started having problems when you got to the
fourth sentence because that is already justifying what the Federal
Government was doing in saying they\'re doing the best they can. I
don\'t believe that\'s the case. I started re-editing that to more
accurately portray. If you want to delete all of that, I think that\'s
fine. Again, I think we need some sort of concluding sentence.

Okay. So, I\'m saying, I\'m suggesting the statement would say, although
there are portions of the system that are very transparent there are
other portions that could be more transparent.

DR. LAYTON: Okay.

DR. SCHECHTMAN: So, if I can go back. You\'ve made a modification to
sentence four in your version.

MR. JAFFE: Yes.

DR. SCHECHTMAN: And \--

DR. LAYTON: Which says \--

DR. SCHECHTMAN: Which says, each federal agency involved in regulation
of medically engineered organisms tries to address transparency of its
actions within the requirements of their legislative mandates and other
laws that address public disclosure of government information such as
the Freedom of Information Act\'s restrictions limiting disclosure of
confidential business information.

MR. JAFFE: Right. That was my edit of that sentence. That\'s correct.

DR. LAYTON: You don\'t like that sentence to begin with.

MR. JAFFE: Yes. If we\'re keeping that sentence in, but, I think
there\'s another sentence that needs to be said. Some members don\'t
believe they\'ve done a very good job at that. That\'s right.

DR. LAYTON: But, what if we don\'t keep that sentence in.

MR. JAFFE: I still think you need something. The first three sentences
is just a bunch of explaining what transparency is. You haven\'t
identified the issue. The issue in my mind is that some will do a better
job than others at that.

DR. LAYTON: Okay. And, so, now what I\'m \--

DR. DYKES: So we leave the sentence and we take this fourth sentence.

DR. SCHECHTMAN: This fourth sentence.

DR. DYKES: Although there are portions of the system, whatever you said,
Greg, that have worked well, other portions could be or other aspects or
agencies or parts could be improved.

MR. JAFFE: That\'s right.

DR. DYKES: Full stop. I think, to me, that\'s fine. That makes the topic
sentence have some meaning. You read three, four sentences and you got
it.

DR. LAYTON: Although some agencies or some aspects?

MR. JAFFE: Other portions of the federal regulatory system.

DR. LAYTON: Portions of the fed reg system.

MR. JAFFE: Have been very transparent.

DR. LAYTON: Have been very transparent.

MR. JAFFE: Other portions.

DR. LAYTON: Other portions have not.

MR. JAFFE: Could be improved. Could improve on this important issue or
improve in this area.

DR. LAYTON: Other portions could improve in this area.

MR. JAFFE: That\'s right.

DR. DYKES: And delete everything else and 16\'s done. Is that what
you\'re saying, Greg?

MR. JAFFE: That\'s what I\'m saying.

DR. DYKES: I would concur with that. That makes much more sense to me
than all the other \--

DR. LAYTON: Would everybody concur with that?

DR. DYKES: \-- you\'ve got here.

DR. LAYTON: Okay. I see heads nodding around the table. Carol and
Margaret.

MS. TUCKER FOREMAN: I\'d say yes and go on before we change our mind.

DR. LAYTON: Okay. Going once, going twice. Okay. Number 16 is now done.
Congratulations. Thank you for your ability to get through the wheat and
chaff.

DR. SCHECHTMAN: Can I just back up for one second?

DR. LAYTON: No, you\'re not going back.

DR. SCHECHTMAN: A little bit of clarification on what you wanted, Greg.
I know people hate this. You wanted the sentence that I read?

MR. JAFFE: Unh-uh.

DR. LAYTON: No. He doesn\'t.

DR. SCHECHTMAN: Get rid of that sentence entirely.

MR. JAFFE: Right.

DR. SCHECHTMAN: The first three sentences.

UNIDENTIFIED MALE: And then the although sentence.

DR. SCHECHTMAN: Got it. Okay. Fine.

DR. LAYTON: Absolutely. The deletion starts on line 544 and a new
sentence is in place and that\'s it. We\'re moving. What number are you
doing next, Abby?

MS. DILLEY: You want to take on 18?

DR. LAYTON: Okay. 18. 18 says no clear comprehensive federal regulatory
system. Animals. This is animals. This is page 14. We have Daryl\'s
comments.

MS. DILLEY: It\'s topic 18, page 16 on the draft that was circulated \--
no, sorry \-- page 19 on the draft that Pat circulated this morning,
version for editing at the January plenary and the colorful draft is
page 14. Carol and Daryl both had suggested editorial comments, I think.
Carol, you had some \--

MS. TUCKER FOREMAN: I can\'t remember.

MS. DILLEY: Why don\'t we take a minute.

MS. TUCKER FOREMAN: Most of them were editorial, I think.

DR. LAYTON: Alison, your comma, I think, I put in. I put it in where you
wanted it to be and because I couldn\'t figure out how to show it other
than that.

DR. VAN EENENNAAM: I\'m glad everybody\'s clear that I put in a comma.

DR. LAYTON: And I can tell you in a minute where you put it in at,
Alison.

DR. VAN EENENNAAM: I\'m sure I\'m comfortable with where you put it.

MS. DILLEY: Okay. Kathleen and then Greg.

DR. JONES: I just have one minor clarification. In the sentence, the
second sentence of the explanation that begins the Office of Science and
Technology Policy published case studies in 2001 that suggested that
there is some transgenic animals that would be considered new animal
drugs. That\'s not the case. It would be that some transgenic animals
would contain new animal drugs.

MS. DILLEY: Would contain new animal drugs?

DR. JONES: Yes. Correct.

DR. LAYTON: So instead of be considered we are making the word contain.
Are you comfortable with that correction?

MS. TUCKER FOREMAN: What does that mean?

DR. JONES: That means the transgenic \-- the way it reads now it says
that transgenic animals themselves would be the animal drugs and the
change I\'m making and the way it was laid out in the OSTP case study is
that these transgenic animals would contain new animal drugs that would
require a review and approval before being able to be marketed.

DR. SCHECHTMAN: So they would be considered to be.

DR. MELLON: But, the risks associated with the new animal drugs are \--
I mean, you know, the risks of the, environmental risks are not of the
drug that you put into the fish. They\'re of the fish in the ocean. So,
if the agency isn\'t asserting jurisdiction over the animals themselves
it\'s even more limited than I thought in its ability to look at the
full range of risks associated with transgenic animals.

DR. JONES: This is the way it was laid out at the OSTP case study.

DR. SLUTSKY: But, you\'re not saying that you\'re not \-- that that
doesn\'t \-- that that precludes FDA from looking at the animal?

DR. JONES: No. The FDA \--

DR. SLUTSKY: She was just clarifying what was in the OSTP.

DR. JONES: Yes. FDA would still have to evaluate the new animal drug and
that means within the animal in

any \--

DR. MELLON: But, I\'m saying the risks of the fish are not the drug in
the fish. They are the fish in the ocean. So, are you asserting
authority over the fish in the ocean and its potential for leading to
disruptions of other fish populations, for example.

MS. DILLEY: Are we blending FDA \-- how FDA is looking at it versus how
the OSTP laid it out?

DR. MELLON: FDA has not yet laid it out.

MS. DILLEY: No, I know. I know. So, you\'re trying to clarify what OSTP
stated?

DR. JONES: Yes.

MS. DILLEY: Which \-- right, so, it would be \-- if we\'re talking about
the OSTP published case study, they didn\'t assume that the transgenic
animal would be a new animal drug. What they said was the transgenic
animal would contain a new animal drug and now FDA\'s trying to figure
out all that stuff out in the middle of figuring out \--

DR. JONES: Yes. And the U.S. Government is trying to figure that out,
yes.

DR. LAYTON: So, she\'s just clarifying what OSTP said, not what FDA\'s
doing.

DR. DYKES: To make it accurate.

DR. JONES: Yes.

DR. MELLON: Okay.

DR. LAYTON: You can still have that argument with FDA.

DR. JONES: And I\'m not the person at FDA to have that argument with.

DR. LAYTON: But, she\'s got the name and number, right?

DR. JONES: Yes, I do.

MS. DILLEY: Greg?

MR. JAFFE: Would this language work for you? You said instead of what
you suggested which would contain a new animal drug to say the Office of
Science and Technology Policy published case studies in 2001 that
suggested that at least some transgenes \-- that transgenes put in some
animals would be considered new animal drugs.

DR. MELLON: The genes aren\'t considered the drugs though. I think the
gene products are considered the drugs.

DR. JONES: I\'m not sure about the clarification about the genes
themselves or just the gene products would be the drugs.

MR. JAFFE: How about that the products from transgenes put in some
animals would be considered new animal drugs?

DR. MELLON: I could go with that.

MR. JAFFE: When you say transgenic animals would contain new animal
drugs it\'s unclear to me that you\'re talking about the transgene is
what \-- unlike the other situations where transgenic animals would
contain a drug that\'s a new animal drug but not \-- you\'re not linking
the genetic engineering process to it here and I was trying to link the
genetic engineering process to it.

So, it would say it\'s suggested that products from transgenes put in
some animals would be considered new animal drugs.

DR. SCHECHTMAN: I think it\'s at least some transgenes produced in
animals would be considered \--

DR. JONES: I don\'t know if it\'s the genes themselves.

MR. JAFFE: It\'s the product.

DR. JONES: I\'m not sure if it\'s the genes themselves is the product.

DR. SCHECHTMAN: At least some products produced in animals. It\'s not
the some animals, it\'s the some products.

MR. JAFFE: I\'m saying that products produced from transgenes put in
some animals. It\'s not all animals. That\'s part of what\'s key to
this. Not all animals.

DR. LAYTON: It\'s transgenic animals.

MR. JAFFE: No, it\'s only some transgenic animals.

DR. MELLON: Right. It\'s only the ones that actually are producing gene
products.

MR. JAFFE: They didn\'t do it for the Glowfish^®^ so it\'s not all
transgenic animals. It\'s only some.

DR. SCHECHTMAN: I think it\'s also not all genes because the gene has to
meet the definition of a new drug.

DR. LAYTON: But it\'s transgenic animal derived products. That some
transgenic animal derived products.

DR. JONES: Might this be easier for me to pull the OSTP document and see
what it says?

DR. LAYTON: That\'s a good idea.

MR. JAFFE: Okay.

MS. DILLEY: We\'re trying to be clear as to what the OSTP document says.

DR. CRAMER: They looked at some and said okay, if you look at the top
transgenic animals some will be regulated under this.

DR. MELLON: Could be.

DR. SCHECHTMAN: I\'ll just set the stage \-- I believe what this
actually says is what\'s here. I went back to case study. We will check
that before tomorrow.

MS. DILLEY: So, first we need to be sure we\'re being consistent with
what the OSTP published case study said and that\'s the homework
assignment, right? Okay. So, then we have other and I think, Greg, you
were next in terms of commenting and then Michael.

MR. JAFFE: I actually have one comment with this whole section and that
was delete those sentences between the 2003 USDA data and my suggestion
to delete that is because, first of all, I don\'t think \-- it doesn\'t
add anything to the topic and when it remains there and I think for some
of us I don\'t think necessarily that \-- I don\'t think it adds
anything so I don\'t think there\'s any reason for it to be in there.

If it is in there then I feel like I have to sort of say that it\'s
unclear if that regulation is satisfactory.

MS. DILLEY: So it\'s basically what are we saying with that sentence?

MR. JAFFE: Right. Why are we putting that sentence in there. It doesn\'t
add anything.

DR. MELLON: I think it does add something. It says to me that even the
USDA thinks that the FDA is not \-- does not have enough authority to
regulate animals and it\'s investigating the use of its own authority so
I think it is an important piece of information. If we want to say that
people have concerns about, you know, the applicability of this, of the
authority that USDA intends to use, then I think that that applies to
the FDA as well.

MS. DILLEY: I thought that it was that there is no clear, comprehensive
federal regulatory system. There are two agencies that are looking at
this. The regulatory

\-- the regulations, that\'s FDA and USDA are both looking at this.

DR. MELLON: Right, but, I don\'t see any reason to, I don\'t know, to
cast aspersions on USDA and not cast them on FDA as well. I guess
that\'s my point.

DR. SLUTSKY: Just as a clarification. If USDA looks at our regulatory
part, it\'s not because we think FDA\'s not doing what they should.

MS. DILLEY: There\'s no clear regulatory system. There\'s been hints
that there is something, that there\'s a lot of discussion about it.
USDA has published case studies. FDA has indicated they\'re looking at
this and have given some signals. USDA\'s also looking at it and, Mardi,
you\'re saying the bottom line is we don\'t know if it\'s going to be
adequate until we\'ve got something out there for us to look at.

DR. MELLON: I really believe that the bland statement, there is no clear
comprehensive regulatory, there is no regulatory system to address the
environmental and food safety system. It isn\'t just that it\'s not
clear and it\'s not comprehensive, it\'s not there. I mean, there is no
articulated policy applying statutes under which anybody wanting to
commercialize an animal can come to USDA. So, I mean, I can live with
this. I\'m not just venting a little.

MS. TUCKER FOREMAN: I actually suggested a rewording of it because it
struck me \-- I\'m sorry for butting in, but, it struck me that it would
as it spans is not enough of an issue to really be talking about.
What\'s the implication that there\'s no clear, comprehensive federal
regulatory system? That the absence of it is likely to arouse public
concerns about the technology and whether it\'s used.

And I thought the colorful document did a pretty good job of smoothing
out some parts of that and I think shortened it. Did shorten it.

MS. DILLEY: Isn\'t there also just \-- I mean, it\'s beyond consumers, I
would imagine, people are trying to market these products can\'t get it
to market.

MS. TUCKER FOREMAN: That\'s a good point. I have public concerns
assuming that would \--

MS. DILLEY: Michael, you had \-- I\'m sorry, did you have comments? So,
we\'re really trying to struggle with what the topic statement says as
well as the explanatory text.

DR. DYKES: Well, I\'m okay with the topic statement and I just think to
me the 2003 USDA looking at it, I\'m kind of where Mardi is. I think it
says there is no clear thing. OSTP laid out some stuff. FDA\'s looking
at it and as far back as 2003 USDA has said they\'re looking at it. So,
this has been going for a while. It still is out there. I think it
provides some context in color to kind of the nature of this thing so
you can say this isn\'t just something brand new; that there\'s some
ongoing things that need to be brought to fruition so that it is clear
for the marketers and the public concern and all these other things.

MS. TUCKER FOREMAN: And I was just suggesting that if you\'re going to
say it\'s not there, you ought to say why that\'s a problem.

DR. DYKES: Maybe, I don\'t know. To me, the logical thing would be the
last sentence you kind of said that it\'s not there, plus, there are
three different efforts out there. The last concluding statement might
be that it\'s important that this be brought to closure for the
consuming public\'s confidence in the food and for the commercial
applications or whatever. I mean, that\'s why you want to do all this.

MS. TUCKER FOREMAN: And I\'ve tried to take it out of the recommendation
language because I think \--

DR. DYKES: Okay.

DR. LAYTON: How about the Abby version of number 18?

DR. DYKES: I liked it.

DR. LAYTON: The last sentence there you\'ve got something didn\'t get
deleted, but, on your version, Abby.

MS. DILLEY: Okay.

DR. LAYTON: Take a look at that last sentence in italics, but, is \--
Abby version is the colorful document working approach \-- working draft
with possible approaches to incorporating comments. It\'s a colorful
document.

DR. VAN EENENNAAM: You just need to take the last five words off
basically and then that sentence becomes \--

MS. DILLEY: Was increasingly important period.

DR. LAYTON: Italicize it then.

MS. DILLEY: Yeah, that\'s the question.

MR. JAFFE: Are you looking at just the last sentence?

DR. LAYTON: No, we\'re looking at the whole of 18 to see if the colorful
document presents the issue as we want it to be presented with the
checking of the considered and contained.

MS. DILLEY: It does say the bottom line the government has issued no
further guidance on the scope or implementation of such a policy.

DR. DYKES: It seems to me you don\'t need the last three or four \--
till the end with research has increased. The use in scientific research
is increasingly important.

DR. LAYTON: Got it. Full stop. Take off research is increasingly
important.

MS. DILLEY: That was a mess, you know, a mistake.

MS. TUCKER FOREMAN: Is increasingly important.

DR. LAYTON: 585. Stop after the first important.

DR. DYKES: I think, to me, the colorful version does a pretty good job
of bringing it all \--

MS. DILLEY: I think its major failing is that it has some have concerns
blah, blah, blah. It doesn\'t really have others. Maybe there isn\'t
others. Maybe everybody wants to see that.

DR. DYKES: Some have. Maybe to say \--

MS. TUCKER FOREMAN: Because that differentiates and I don\'t think there
are differences within the committee and that would \--

DR. DYKES: Well, you say there are concerns.

DR. LAYTON: And the FDA\'s new animal drug regulatory process is not \--
I thought you told me they didn\'t have one.

MR. JAFFE: They have a new animal drug process. There\'s no question
about that.

DR. LAYTON: It\'s not transparent.

MR. JAFFE: Right. There\'s no question about that. How applicable it is
to transgenic animals is \--

DR. DYKES: You may want to delete that sentence because it\'s not
talking directly to the topic of new transgenic animals. I don\'t know.

MS. TUCKER FOREMAN: Which is why I changed it a little bit because I do
think that\'s an important piece. It is important. It\'s a process but
it\'s a process that\'s going to get you kind of acceptance that will
let the technology move forward.

DR. DYKES: So, I guess what you all are saying is although we\'re
talking about a policy on transgenic animals since the current general
theme is to come at it from a new animal drug perspective it\'s
important to point out the problems using the new animal drug process.
Is that the \-- okay. So, maybe \--

MS. TUCKER FOREMAN: You think one should say the problem with the new
animal drug.

DR. DYKES: Right. You know, they recited it. That\'s what they\'re
doing. They look at the animal. There are concerns that the FDA\'s using
the new animal drug process it is not transparent, participatory. That
gives a little more reason to be in here.

DR. LAYTON: If we put that second new animal drug in quotes to refer
back to the first new animal drug in quotes does that make it clearer?

DR. DYKES: It may. I just think it would tie better to the \-- it has
more context for that paragraph. Putting it in quotes doesn\'t.

MR. GRANT: How about the suggestion on line 574 of the colorful version
it would say \--

MS. TUCKER FOREMAN: What line?

MR. GRANT: 574 of the colorful.

MS. TUCKER FOREMAN: Yeah.

MR. GRANT: There are concerns that FDA\'s new animal drug regulatory
process will be used to regulate transgenic animals, but, it is not
transparent and participatory.

MS. TUCKER FOREMAN: If you could say there\'s \-- you can say that it
will be \-- that the new animal drug regulatory process which is not
transparent and regulatory and participatory will be used.

MR. JAFFE: How about \-- yeah.

MS. TUCKER FOREMAN: Go ahead. I\'m just trying \--

MR. JAFFE: I would say there are concerns that if the new animal drug
regulatory process is used to regulate transgenic animals, it is not
transparent.

DR. SCHECHTMAN: Or, could you leave out the transparent and
participatory and say there are concerns that if this process is used,
the general public will have no access to any information and there will
no provision for public participation in the process?

MR. JAFFE: I think you need both in there.

DR. MELLON: I think you need to point out that it\'s this.

DR. DYKES: Now we\'re getting to fixing it so that it ties into what I
said.

MS. TUCKER FOREMAN: Yeah. Yeah.

DR. LAYTON: Okay. So, what was the \-- I\'m sorry, go ahead.

DR. SLUTSKY: So, essentially what you\'re saying is, you know, the U.S.
Government has not articulated anything about transgenic animals, but,
to the extent that they do, it\'s the sense of this committee that using
\-- that FDA using their new animal drug regulatory authorities would
not be adequate?

MR. JAFFE: It\'s a problem.

DR. DYKES: There\'s a problem in transparency participation are the two
main areas.

MS. TUCKER FOREMAN: There are problems in using the FDA new animal drug
process because it is not participatory, isn\'t transparent, and some
people think that it doesn\'t apply to the full range of animal issues.
Does that answer?

DR. SLUTSKY: You\'re not suggesting that they should not use those
authorities?

MS. TUCKER FOREMAN: No. It just \--

MR. JAFFE: It\'s pointing out.

DR. DYKES: If you rely solely on that as it is now it will be deficient
in those areas. Is that all right, Carol?

MS. TUCKER FOREMAN: Yeah.

DR. DYKES: It\'s okay to use it. Just recognize it doesn\'t go far
enough.

MS. TUCKER FOREMAN: It\'s a fairly simple sentence. And I think the key
there may be that since it\'s preceded by the government\'s issued no
further guidance then if they rely on the new animal drug the absence of
transparency and public participation and full environmental review may
be a problem.

DR. DYKES: There are concerns about lack of transparency, participation.

MS. TUCKER FOREMAN: If they do use it the lack of transparency, public
participation, and full environmental review, power, may be a problem.

DR. MELLON: It is not may be. It is a problem.

MS. DILLEY: So, it says OSTP publishes cases studies where, and we\'re
checking language, new animal drugs would require approval from FDA for
marketing. Then you say, however, the government has issued no further
guidance on the scope or implementation of such a policy. If the \--

MR. JAFFE: If FDA uses the new animal drug process to regulate
transgenic animals, there are concerns that that process is not
transparent and participatory.

MS. DILLEY: Transparent, participatory.

MS. TUCKER FOREMAN: Let me put it this way. Uses the new animal drug
process which is not transparent or participatory and has no \-- and
doesn\'t have full environmental.

MR. JAFFE: It\'s a later sentence.

MS. TUCKER FOREMAN: Okay.

UNIDENTIFIED FEMALE: Well, what she said was there are concerns \--

MR. JAFFE: I think \-- I mean, make less changes just to \-- I\'m
looking at Abby\'s draft. It says, however, the government has issued no
further guidance on the scope or implementation of such a policy. If FDA
uses the new animal drug provisions to regulate transgenic animals,
there are concerns that the regulatory process \-- there are concerns
that \-- there are concerns that FDA\'s regulatory process is not
transparent and participatory period and then just continue on.

DR. LAYTON: Kathleen?

DR. JONES: I\'d like to phrase that a little differently because it\'s
not a matter of FDA using its new animal drug regulatory process. It\'s
the way these products will be regulated will be determined by the U.S.
Government. It won\'t be FDA just deciding we\'re going to use our new
animal drug provision. So, it will be if FDA\'s new animal drug
regulatory process is used to regulate transgenic animal drugs.

DR. LAYTON: Let\'s make sure that Cindy and Alison hear that. If FDA \--

DR. JONES: If FDA\'s new animal \--

DR. LAYTON: If FDA\'s new animal drug policy \--

MR. JAFFE: Process.

DR. JONES: If FDA\'s new animal drug regulatory process is used to
regulate transgenic animals.

DR. LAYTON: If FDA\'s new \--

DR. JONES: Animal drug regulatory process is used.

DR. LAYTON: Is used. Okay. Got it.

MR. JAFFE: There are concerns.

DR. JONES: There are concerns \--

MR. JAFFE: That FDA\'s procedures are not transparent. The process,
FDA\'s process.

DR. JONES: There are concerns \--

MS. TUCKER FOREMAN: There are concerns about the lack of public
participation.

MR. GRANT: Do you want participation, transparency, and the
environmental?

MS. TUCKER FOREMAN: That\'s another sentence.

MR. GRANT: Okay. All right.

MR. JAFFE: There\'s another sentence.

MR. GRANT: Sorry.

MS. TUCKER FOREMAN: For the sake of simplicity.

DR. DYKES: Get rid of participatory.

MR. GRANT: I think I\'d put transparency ahead of participation.

DR. DYKES: Could you read it to us now?

MS. SULTON: The government has \--

DR. LAYTON: Whoa. Okay.

MS. SULTON: I have it here. However, the government has issued no
further guidance on the scope or implementation of such a policy. If
FDA\'s new animal drug regulatory process is used to regulate transgenic
animals there are concerns about transparency and the lack of public
participation in the process.

DR. VAN EENENNAAM: About the lack of transparency and participation?
About the lack of?

MS. TUCKER FOREMAN: Yes. The lack of.

MS. SULTON: The lack of transparency and public participation in this
process.

DR. LAYTON: Okay. Is the next sentence then following okay?

MS. TUCKER FOREMAN: Yeah.

DR. LAYTON: Is that not duplicative? Can we take out the next sentence?

MS. TUCKER FOREMAN: No. No. You need to say that \--

UNIDENTIFIED FEMALE: Is that out?

MS. TUCKER FOREMAN: Yeah, that\'s out.

DR. LAYTON: Yeah, that goes out.

MR. GRANT: No, it wasn\'t.

MS. TUCKER FOREMAN: The next one was the thing about legal authority for
environmental.

DR. MELLON: No, that\'s in the next sentence.

DR. LAYTON: Can we take out the sentence, the general public has no
access to any information in the proposed new process and there is no
provision. That can go? Okay.

DR. VAN EENENNAAM: There are also concerns \--

DR. LAYTON: There are also concerns FDA has adequate legal, right? Okay.
To assess and address the full range of environmental risks that could
arise from different transgenic animals and I think that\'s parens,
particularly fish.

DR. DYKES: I think we stop it with animals.

DR. LAYTON: Take out particularly fish?

MS. TUCKER FOREMAN: Yeah. Because that was an environmental risk that
could arise period.

MR. GRANT: Yeah, period. I agree.

MS. DILLEY: Could arise period. So, the clause from different transgenic
animals is out?

MR. GRANT: It\'s larger than \--

MS. TUCKER FOREMAN: I think it\'s \--

DR. MELLON: I don\'t know what different transgenic animals means.

DR. VAN EENENNAAM: I think it was different transgenic.

MS. DILLEY: Okay. Period after arise. Okay.

DR. LAYTON: Then it goes in 2003 USDA indicated it had \-- it was
reviewing whether it might have the legal authority to regulate certain
transgenic animals. As research involving transgenic animals moves
toward commercialization a credible, appropriate, and transparent
federal regulatory framework applicable to such products as food
animals, animals genetically engineered to produce specialty products
such as drugs or spider silk, and non-food animals other than those sold
for use in scientific research is increasingly important.

MS. TUCKER FOREMAN: We agreed earlier, I think, to drop everything
between engineered and this increasingly important.

DR. LAYTON: Okay. So, after it we\'re dropping to produce specialty
products all the way down to \--

MS. TUCKER FOREMAN: It says as research involving transgenic animals
moves toward commercialization a credible, appropriate, and transparent
federal regulatory framework applicable to these animals is increasingly
important.

DR. LAYTON: It\'s okay so far.

MS. TUCKER FOREMAN: That was the suggestion, wasn\'t it, Michael?

DR. DYKES: No, not really. I mean, I\'m not saying I had a problem. My
suggestion was that down at the end Abby had it kind of messy. I was
just suggesting we delete as research is increasingly important.

DR. SCHECHTMAN: That\'s gone.

MS. TUCKER FOREMAN: That\'s gone?

DR. SCHECHTMAN: No, no, it\'s duplicative at the end of the sentence.

DR. LAYTON: Let\'s read this and see if we need those identifiable
pieces of animals.

DR. DYKES: I was thinking leave them in there because Daryl had them. It
was my fault.

DR. LAYTON: But, simpler and shorter is better, so, if we can. Is that
okay with everybody? You can delete that section.

MR. GRANT: What\'s our next one, Abby?

DR. LAYTON: Okay. Everybody, this is your last chance.

DR. DYKES: Can you read it? We can\'t see it.

DR. LAYTON: Okay. There is no clear, comprehensive federal regulatory
system to assess the environmental and food safety of transgenic animals
before they are commercialized. Topic sentence.

DR. DYKES: That\'s the topic sentence, yeah.

DR. LAYTON: The next generation of genetically engineered products will
include transgenic food as well as non-food animals. The Federal
Government has not clearly indicated how and under which laws and
regulations transgenic animals will be regulated. The Office of Science
and Technology Policy published case studies in 2001 suggesting that at
least some transgenic animals would be considered new animal drugs and
would require approval by FDA before marketing. That sentence is under
review for writing.

DR. DYKES: For accuracy.

DR. MELLON: Yeah.

DR. LAYTON: However, the government has issued no further guidance on
the scope of implementation of such a policy. If FDA\'s new animal drug
regulatory process is used to regulate transgenic animals there are
concerns about the lack of transparency and public participation in the
process. There are also concerns about whether FDA has adequate legal
authority to assess and address the full range of environmental risks
that could arise.

In 2003 the USDA indicated it was reviewing whether it might have legal
authority to regulate certain transgenic animals. As research involving
transgenic animals moves toward commercialization, a credible,
appropriate, and transparent federal regulatory framework applicable to
these animals is increasingly important.

MS. DILLEY: Does that say USDA also is reviewing whether \--

DR. DYKES: I would keep it in.

DR. LAYTON: In 2003 it indicated it was.

DR. DYKES: I would keep in what Daryl had in there in that last
sentence.

MS. TUCKER FOREMAN: The list of the animals?

DR. DYKES: Yeah. I just think it just adds a little more clarity.

DR. MELLON: I agree.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: That\'s fine.

DR. DYKES: He\'s not here to defend this so he may have some \--

DR. HUNT: Just back to the third sentence. It just doesn\'t read well to
me. It says the next generation of transgenic products will include
transgenic food as well as non-food animals. I just think an example
would be the next generation of genetically engineered products will
include food and non-food products from transgenic animals. Just enough
to make it read better. It\'s an editorial.

MR. JAFFE: It\'s only about animals.

MS. TUCKER FOREMAN: Animals created or bred for both food and non-food
purposes. Because this is just about animals.

DR. HUNT: Yeah, yeah, that\'s what I said. My suggestion was the next
generation of genetically engineered products will include food and
non-food products from transgenic animals.

MS. TUCKER FOREMAN: Oh, okay. Okay. I\'m sorry, I didn\'t hear part of
it.

MR. JAFFE: Just so that we\'re not \-- it\'s the animals we\'re talking
about, not that they\'re not food products. Your suggestion about food
and non-food products from transgenic animals. Here we\'re talking about
food and non-food animals.

MS. TUCKER FOREMAN: That\'s right.

DR. MELLON: I like animals raised for food and non-food.

MR. JAFFE: The first one captures the products from the animals, not
there\'s just going to be non-food animals. Transgenic non-food animals.
They don\'t have to be products.

DR. DYKES: How about will include transgenic animals as well as food and
non-food products from transgenic \--

MR. JAFFE: From the animals suggest that the animal itself is not the
product, but, there\'s something from the animal.

MS. TUCKER FOREMAN: If you say animals bred for both food and non-food
purposes \--

MR. JAFFE: Right.

DR. MELLON: I like that.

MS. TUCKER FOREMAN: \-- I think you get it.

DR. HUNT: Yeah, and it reads better to me than the original sentence.

DR. LAYTON: Did that get in?

MR. JAFFE: Not yet.

MS. DILLEY: Not yet.

DR. MELLON: Somebody write it.

MS. DILLEY: I\'m writing. Bred for food and non-food products. Purposes.
We have Daryl\'s list back in.

MS. TUCKER FOREMAN: See what challenge she has for us next.

MR. GIROUX: I just have one comment. You\'re talking about in 2003 USDA
indicated that they\'re doing research. They either are reviewing it,
or, they did, or, they\'re not, or, do we know if they are?

DR. LAYTON: That review is continuing since?

MR. GIROUX: We can say since 2003 they have been reviewing?

DR. LAYTON: All we really know is they said they were going to do it.
Bernice, you can clarify that if you want.

DR. SLUTSKY: The U.S. Government is still in discussions.

MR. GIROUX: So, maybe we should say that instead of \--

DR. SCHECHTMAN: I mean, and part of the reason that this indication has
been was because the laws that the legal authority for USDA to address
some animal issues with the farm bill of, I forget which year, \--

MR. JAFFE: The 2000 animal \--

DR. SCHECHTMAN: The animal section act.

MR. JAFFE: They had three years to figure out that they should look at
this. That\'s the only factual thing we have on the record so I just
think we ought to stick with that.

DR. DYKES: It says it\'s almost three years old now and we\'re still
saying indicated that \--

MR. JAFFE: That\'s the only thing they said.

DR. DYKES: Can we say they started reviewing?

MR. JAFFE: No.

DR. MELLON: This is the U.S. You don\'t know if you\'re still doing it?
I mean, that doesn\'t make sense.

DR. SLUTSKY: The U.S. Government is in discussion. They\'re still
discussing. It\'s not \--

DR. MELLON: Maybe we should say that.

DR. SLUTSKY: There\'s not a lot more information.

MR. JAFFE: I think we should stick with that statement. That\'s a
factual statement that in 2003 there are no \--

UNIDENTIFIED FEMALE: I think the point you\'re making is we haven\'t
completed it.

MR. JAFFE: We can say that. If you want to say

\-- add another sentence. If you want to add another sentence.

DR. LAYTON: Let me suggest this. I\'m going to suggest this. After the
word animals on line 626, this is in the version for editing before we
go to the credible transparent thing, could we state the committee found
no conclusions.

MR. JAFFE: I think it\'s fine the way it is.

DR. DYKES: Leave it alone.

DR. LAYTON: Leave it alone. Let it go. It\'s obvious that somebody\'s
missing the boat.

MR. CORZINE: I would put is rather than was because it indicated it is
reviewed.

DR. LAYTON: It was three years ago and they\'ve not done anything else.

MR. JAFFE: That\'s what it did. It said at that time we\'re reviewing
this, but, it\'s now \-- it is past tense.

MS. TUCKER FOREMAN: We don\'t know if they still are.

DR. LAYTON: We don\'t know anything. Let\'s just leave it alone.

MR. JAFFE: But, this, "in 2003" was specific to USDA was looking at its
regulatory authority track. That\'s what they said in 2003. They came
out with a statement that said we are looking at it and I think this is
an accurate statement. That\'s different than the U.S. Government has
\-- if you want to say the U.S. Government has an interagency committee
that\'s looking at a host of issues \--

UNIDENTIFIED FEMALE: Well, I\'d like to say that because \--

MS. DILLEY: I think we\'re still saying it. We\'re still trying to state
what\'s in there. It was informative. It was reviewing in 2003. There\'s
been nothing else stated so I don\'t know how you could say it is
reviewing because nothing further has been done.

DR. VAN EENENNAAM: There\'s been no public statement.

DR. LAYTON: Are we finished with this one?

(Discussion off the record)

DR. SCHECHTMAN: Are we putting this one to bed?

DR. LAYTON: Yes.

MS. DILLEY: Well, do you want to take a look at 23 because we didn\'t
give you correct language on the compilation document?

DR. DYKES: Is that 515?

MS. DILLEY: I think it was 515.

DR. DYKES: We\'ve got 30 minutes. So, do you have one we can do \--

MS. DILLEY: I just want to \-- I want to do at least a first pass at 23.

DR. LAYTON: 23.

MS. DILLEY: So, if you\'d just look at the document that was handed out
this morning.

DR. LAYTON: And it is two-sided.

DR. DYKES: So, this one pager is what, everybody\'s comments or what is
this?

MS. DILLEY: If you\'ll look on the back, yeah.

DR. SCHECHTMAN: Actually, what this 23 is, there were not many comments
on 23. Not quite all of the text was circulated. This 23 was a version
that was put together with \-- out of comments from phone calls from
both points of view and, Abby, you put \--

MS. DILLEY: Yes, this is my document.

DR. SCHECHTMAN: You assembled this from pieces from both.

DR. LAYTON: And it is \--

MS. TUCKER FOREMAN: But, she asked for suggestions from different \--

DR. LAYTON: Right. She went around and got it. It is in this document as
it is in this document without the underlines and the other stuff.

MS. DILLEY: The compilation document unfortunately lopped off the last
paragraph. There also weren\'t comments probably because you all ran out
of gas before you hit 23, but, \--

DR. VAN EENENNAAM: I want to make a clarification.

MS. DILLEY: Okay.

DR. VAN EENENNAAM: The one that was sent out by Pat, whenever, we were
to edit it, is not even \-- there\'s not one piece of language that\'s
the same that was sent out in the compilation document and, so, the
language that we were putting edits on is nowhere to be found in
anything that we\'ve got on the later version and, so, I think that I,
personally, am safe in saying I have substantial comments on the stuff
that\'s been circulated after the 18th because that\'s a writing that we
never saw before until we got it at Christmas but we haven\'t had a
chance to comment on it at this stage.

DR. LAYTON: Correct.

MS. DILLEY: Okay. So \--

DR. LAYTON: Nobody has had a chance to comment on the 23 that you sent
out.

MS. DILLEY: Yes, that\'s right.

DR. LAYTON: Even without the missing paragraph.

MS. DILLEY: Okay.

DR. LAYTON: So, I would prefer that people work on this tonight. Let\'s
choose another one today now.

MS. TUCKER FOREMAN: You want people to go home and read this one and
think about it and then come back?

DR. LAYTON: Yes.

MS. DILLEY: Because then that gives you an opportunity to review it.

DR. LAYTON: How about 22?

DR. VAN EENENNAAM: I guess we did have wording that was in 23 that\'s
now been totally removed from the table that nobody has a copy of unless
they happen to bring along their 12/18 version and I don\'t show \-- if
we want to go at this from the text we got in late December or what had
originally been agreed on on the 12/18 one \--

DR. SCHECHTMAN: Actually, let me. We had a phone conversation. We had a
telephone conversation, an open-ended work group on which this one was
discussed, at which time very substantial problems emerged with the old
language, the result of which was that this was assembled with a version
containing views from the two different perspectives on this issue.

That\'s how this came about. It did not get assembled perhaps in time to
make it into \--

DR. LAYTON: It didn\'t make it into the first draft I sent out which
went out looking like a real document which was on the 12th. It did not
get into that. The majority of it got into the version that I sent out
on the 22nd, except for one paragraph.

DR. VAN EENENNAAM: Right.

DR. LAYTON: But, again, there have been no time to take comments on the
version that we sent out on the 22nd.

DR. VAN EENENNAAM: There wasn\'t.

DR. LAYTON: There was no interim turnaround. Alison\'s very correct.
However, it had a lot of comments and a lot of thought and a lot of
rewriting based on a phone call.

MS. TUCKER FOREMAN: And there were two or three, one where Carole Cramer
and Daryl tried to write \-- no, not this one, but, another one where in
order to save time in a couple of places people went off to do this and
Abby asked people who had very different views on it to see if they
couldn\'t \-- there were two or three sentences and then she put them
together. And that\'s the problem of this.

DR. LAYTON: So, I\'m comfortable if people want to look at this tonight.

MS. DILLEY: So you want to set this one aside.

MR. CORZINE: Is this in the side-by-side where Alison has scratched out?

DR. LAYTON: That was the old, old stuff.

MR. CORZINE: Was that the original?

UNIDENTIFIED MALE: No.

DR. LAYTON: She commented on the original, but, that has nothing to do
with what\'s here.

MR. CORZINE: Okay.

DR. LAYTON: Because Alison had gotten her comments in like two weeks
before everybody else did.

DR. VAN EENENNAAM: I did not.

(Discussion off the record)

DR. LAYTON: Do we have another one we can work in 15-20 minutes?

MS. DILLEY: Well, I just am trying to act in the reality of time which
topic to pick.

MS. TUCKER FOREMAN: While you\'re doing that, let me say I was standing
with Josephine and Ron trying to come up with a statement of the three
groups on the \--

MR. OLSON: 14.

MS. TUCKER FOREMAN: \-- 14 and it\'s my view it was clearly stated in
that first group. As we were talking I wasn\'t sure that we had actually
three separate groups or two and I came away from it confused. We might
well spend the last few minutes going back and seeing if we really have
two or if we have three.

MS. DILLEY: Sounds good. Let\'s do that. If we can wrap that one up that
would be great. Okay. Why don\'t we try and tackle 14 and finish it up
and then if we have any more time than that \--

MR. CORZINE: Carol, did your group \-- did you get a chance to talk
about changing that consumer language where it would fit in the general
and move it up? Is that \--

MS. TUCKER FOREMAN: Yes. That\'s in there. That\'s in there, Leon. Take
a look at it as it is now. What the problem seems to be is, and I have a
hard time distinguishing the group that says it\'s okay to use food
crops because we can contain it and the group that says I think we\'d
rather not use food crops for fear that you can\'t contain it, but, if
you do get this product, these organisms in through a food product,
there needs to have been a process that assures that they\'re safe.

But, that was how I heard it, but, I\'m not sure that Ron and Josephine
had described their positions so I think I ought to withdraw from where
we are right now.

MR. CORZINE: Okay.

MS. DILLEY: Can you all see it or do you want it read?

DR. DYKES: I like it read because I can\'t see.

MS. DILLEY: There is a major concern that food crops genetically
engineered to produce medical and industrial products never intended for
food or feed could inadvertently end up in a food or feed product. Using
genetically engineered organisms designed for medical and industrial
markets could offer substantial health and economic benefits.

There are a number of new products under active development in these
categories and the majority of those are being produced from plants that
have been engineered for production using important food crops. All
committee members agree that consumers do not want unexpected and
unintended substances in their food.

One group of committee members believes that the Federal Government
should not approve the use of food crops for the production of medical
and industrial substances even if deemed safe because no regulatory
process or containment can ensure that food and feed products will never
enter the food supply.

Other members think that it is possible to successfully contain these
crops containing these substances. This group believes that adequate
regulatory oversight and appropriate industry standards will prevent
these products from entering the food supply.

Still, another group, while preferring the use of non-food crops for
such products, believes that if food crops were to be used, appropriate
allowances for meeting food safety standards were raised, then federal
regulations could provide for food containment and food safety
assessment.

MS. TUCKER FOREMAN: Well, that\'s where we\'re running into the problem.
I\'m not sure. So, people ought to just discuss it and see if there are
three positions.

DR. DYKES: Well, to me, the place of the confusion is, if I\'m correct,
is in position 2 and 3. We\'re fine until we get to the second and third
group.

MS. DILLEY: It\'s pretty clear, right.

MS. TUCKER FOREMAN: We thought to have the ones that say never and the
ones that say you can successfully contain it and then the third is what
I call the rational group. You know, I don\'t agree with them.

MR. CORZINE: I think first up there there was a thing that I think that
Carole Cramer brought up on the \-- maybe if scroll up before we get to
the different groups. The majority is not accurate.

(Discussion off the record)

MR. JAFFE: Well, is it a majority?

UNIDENTIFIED FEMALE: Of the ones that are there.

MR. JAFFE: That have been approved. The last few years it has been.

MS. DILLEY: So is it many of those being produced or many of those
approved in plants?

DR. LAYTON: No, it\'s many of.

MR. JAFFE: That are being tested. That are being developed.

MS. DILLEY: That are being tested?

MS. TUCKER FOREMAN: Being developed.

MR. JAFFE: Being developed.

MS. DILLEY: Being developed.

DR. CRAMER: If you look at what\'s being developed now, I would say that
those in major food crops are the minority. If you look at what\'s in
the field trials

that\'s \--

MR. JAFFE: They\'re in the majority.

DR. LAYTON: Okay. So, many of those are in the field trials.

MR. JAFFE: The ones that are getting to market, they\'re going to be
field trials. The things that are farther back are not that close to
market.

DR. LAYTON: So, many of those in field trials? Are you comfortable if
that\'s correct?

DR. SCHECHTMAN: Many that have been field tested having been developed
in.

DR. MELLON: The majority by far that have been field tested have been
food products. Corn. A number of years ago corn was just by far the \--

MS. TUCKER FOREMAN: We just have to \-- you know

\-- are we talking field trials or \--

DR. CRAMER: It\'s actually moving towards human clinical trials; the two
that I know of are derived from tobacco.

MR. JAFFE: If none of them are approved then this issue is a meaningless
issue. So, but, none of us around the table think this is a meaningless
issue. So \--

DR. LAYTON: But, we had that guy come in and talk to us and he was doing
something on corn.

MR. JAFFE: And that\'s been three years ago. Anheuser Busch thought this
was an issue.

MS. DILLEY: Many of the field tested ones have been in major food crops.
Many under development are in the \-- I\'m trying to get to the point,
Carole \--

DR. CRAMER: Why not say some. Some of these. Because that\'s the issue.
Some are in food crops. Many\-- make the adjustment that have to be
gone.

MS. TUCKER FOREMAN: It doesn\'t make a judgment but it requires data so
let\'s say so.

MS. DILLEY: So, there are a number of new products under active
development in these categories. Some of these products have been
developed \--

MS. TUCKER FOREMAN: Instead of the majority \--

MS. DILLEY: \-- using and growing food crops. Using food \--

DR. LAYTON: Some have been engineered for products for production using
food crops.

MR. CORZINE: Go back to the other sentence and just put some.

DR. CRAMER: I thought you went to get back and say majority.

MS. DILLEY: Majority is gone. It\'s some of these products.

MS. TUCKER FOREMAN: It said under active development and some are being
produced.

MS. DILLEY: Have been developed in plants. No?

DR. CRAMER: Go back to the original and just state majority in place of
some. That\'s all.

MS. TUCKER FOREMAN: And some of those being produced in plants have been
engineered for production in important food crops.

DR. VAN EENENNAAM: Replace many with some.

MR. JAFFE: Some of those.

MR. GRANT: Now, before we leave here, I\'ve got a problem with that next
sentence. All committee members agree that consumers do not want
unexpected and unintended substances in their food. That\'s awfully
broad. I mean, they get unintended, unexpected substances all the time.

MS. TUCKER FOREMAN: And when they find out that they\'re there they
don\'t like it at all. You tell them that FDA allows a certain number of
rat hairs in a container of flour, I can get on local television any day
of the week if I want that out.

MR. GRANT: Right. But, still, it doesn\'t change the issue and I\'m not
talking about rat hairs actually. But, there\'s a number of sentences.
We can make a long list that end up in food that consumers have no idea
is going to be there \-- aren\'t going to be there.

MS. TUCKER FOREMAN: But, if they know. These may get there and consumers
never know it. It\'s when they know that they\'re there is a problem.

MS. DILLEY: How would you change it?

MR. JAFFE: Just say such substances in their food they do not want.

DR. MELLON: They do not want to discover unexpected and unintended
substances.

DR. CRAMER: I think we need to say all members agree. Just say \--

MS. DILLEY: Not want substances in their food.

MS. TUCKER FOREMAN: I think Carole Cramer\'s got it. Say \--

DR. LAYTON: Say again.

MR. GIROUX: Cross out committee members.

MS. DILLEY: Consumers do not want.

DR. CRAMER: Consumers generally do not want.

MS. TUCKER FOREMAN: Generally is the qualifier and I think that\'s
important there.

MS. DILLEY: Okay. Consumers generally do not want unexpected, unintended
substances in their food?

MR. GRANT: I would still prefer such substances in their food. We\'ve
already said they\'re unexpected and unintended. Thank you.

MS. DILLEY: Carole, are you okay?

DR. CRAMER: Good. Listen, I would like some more antibodies in my food.

MR. GRANT: She\'s a specific consumer.

MS. DILLEY: Okay. One group of committee members believes that the
Federal Government should not approve the use of food crops in the
production of medical and industrial substances even if contained
because no regulatory process or containment system can ensure that
these products will never enter the food supply.

Then the question is, other members are trying to see if there\'s still
others and others. Other members believe that it is possible to
successfully contain these products with these substances \--

DR. VAN EENENNAAM: Producing?

MS. DILLEY: Contain these substances?

DR. VAN EENENNAAM: Producing these substances? Contain crops producing
these substances?

DR. CRAMER: Why do we need both sentences? Other members believe that
adequate regulatory oversight and appropriate industry standards.

MS. TUCKER FOREMAN: If you say that then I don\'t think that you have
three groups.

MR. GIROUX: In fact, I don\'t think we have three groups.

MS. DILLEY: I think we\'re reaching agreement that we don\'t have three
groups.

DR. VAN EENENNAAM: Other members believe \--

DR. DYKES: Well, delete the second group and see if everybody\'s
comfortable.

MR. GIROUX: There\'s a risk management part of it too.

MR. CORZINE: Wouldn\'t that do it? Other members believe that adequate
regulatory oversight. Abby, other members believe that adequate
regulatory oversight, okay.

DR. DYKES: Don\'t think it\'s possible to contain. I think that the
products may be safe and I think there may be levels of tolerance that
can be set, but, I don\'t think it\'s possible to entirely contain them.

MR. JAFFE: That\'s where you\'re missing \-- you guys took out from the
third group was the sentence that said that the \-- and you have to go
farther down that says that it wants the Federal Government to
acknowledge that these things can\'t be contained and that we need to
set up tolerances and other things.

That\'s key to that analysis being true.

MS. TUCKER FOREMAN: To ensure safety and tolerances.

MR. JAFFE: That\'s the group that Jerry and I are in.

MR. SLOCUM: That is the second group.

MR. JAFFE: That is the second group.

DR. VAN EENENNAAM: We haven\'t got to the second group yet.

DR. SCHECHTMAN: May I back up for a second. I think I\'ve heard two
different third groups. One articulated by Jo and another which was more
of the original articulation.

MS. TUCKER FOREMAN: Michael, do you understand that when we got up to do
this we switched what we originally had as group three \--

DR. SCHECHTMAN: Yes, yes.

MS. TUCKER FOREMAN: \-- with group two?

DR. SCHECHTMAN: Yes. I know that. I\'m talking about this intermediate
group and my \--

UNIDENTIFIED FEMALE: We haven\'t done that.

DR. LAYTON: I understand that. That is now group three, but, it\'s my
sense that the description that Greg and Jerry just \-- or Jerry and I
forget who else, Greg, just gave for a third group is a bit different
than what I\'m hearing from what Jo was saying about a third group.

Let me check with Jo.

DR. HUNT: The third group, \--

DR. SCHECHTMAN: Your version.

DR. HUNT: \-- according to the way we worded it now, where we say that
this group prefers the use of non-food crops, however, recognizes that
food crops may be used and there has to be containment, et cetera, but,
they\'re not comfortable with having tolerance and that\'s different to
what the second group is saying.

DR. SCHECHTMAN: So, that\'s a different third \--

MR. JAFFE: Is not comfortable with the tolerance you\'re saying.

DR. HUNT: Right. Not comfortable with tolerance. DR. SHURDUT: That\'s
not true.

DR. CRAMER: Let\'s go step by step. Now group two is basically a \--

MS. DILLEY: Carole \--

DR. CRAMER: I think if you just take that and shorten it and say other
members, make it one sentence, believe that adequate regulatory, that
finishes that group.

MS. TUCKER FOREMAN: No.

DR. CRAMER: Yes.

MS. TUCKER FOREMAN: The regulatory what?

DR. CRAMER: Oversight appropriate industry. So, that \--

DR. LAYTON: Let her finish the believe. Okay.

DR. CRAMER: I mean, that \--

UNIDENTIFIED MALE: Does that do it, Carole?

DR. LAYTON: That\'s Carole.

DR. CRAMER: Yeah, that\'s fine with me.

DR. LAYTON: Okay.

DR. CRAMER: Now, go to the next group and let\'s figure out something
that makes everybody \--

MS. DILLEY: Still another group.

DR. LAYTON: Okay. Is this the Jerry/Greg one?

MS. TUCKER FOREMAN: I have a question about Carole. I understood that
you were saying that with adequate regulation you will successfully
contain these products. They will not get in the food products.

DR. CRAMER: I just put \--

MS. TUCKER FOREMAN: Because I think that

there\'s \--

DR. CRAMER: And it\'s not a statement that adequate is necessarily in
place now but that they can do that.

MS. TUCKER FOREMAN: I understand that.

MR. GRANT: I have one question for Carole also. Just kind of a reality
check. Is that regardless of scale? Or, do you want to put a qualifier
on that?

DR. CRAMER: I mean, I think that as with anything in the current
regulatory system every single product needs to be looked at from that
point of view and the types of regulations and containment issues that
you may have or something used as an energy or a large scale plastic
would be different than a pharmaceutical that has a bioactive form on
it.

But, do I believe that in fact we can come up with regulatory standards
that would ensure segregation, I think we can.

DR. LAYTON: This is Carole and what she says is correct. Let\'s move to
the next group. Brad.

DR. SHURDUT: Just to ask before we go and, again, when we think about
this I think we\'re talking about different shades of gray here. I think
you can develop a regulatory standard that can get a hundred percent
containment for several uses and applications. In the event, like when
you have large scale, you go to industrial, that you cannot seek
containment. The regulatory system allows for this alternative
tolerance, a development of an alternative tolerance level.

But, it\'s part of the regulatory scheme but it\'s stepwise progression
based on the size, the type, and modality. I\'m saying in certain cases
and uses it\'s in a greenhouse, if it\'s included you can do it, it gets
larger, bigger, industrial, then you go to the level number three. So,
it\'s part of the regulatory sort of staging of the product.

DR. LAYTON: So, are you wanting to change the middle paragraph?

DR. SHURDUT: That\'s why I say two blending into three. It\'s the
regulatory phase.

DR. LAYTON: But, I still think there\'s a difference.

DR. SCHECHTMAN: I think there\'s another three.

MS. ZANNONI: It\'s not three. It\'s not the same as the original two.

MR. JAFFE: I mean, you can come that way. It\'s a different premise. The
premise on two is that you can contain these. The premise on three is
you can\'t contain them. And the regulatory system has to acknowledge
that and put in things related to that. It\'s a different premise. I
understand you think it\'s the same. I don\'t think it\'s the same.

DR. SHURDUT: I\'m saying contained in certain cases, in certain
applications.

MR. JAFFE: That statement there will prevent those products from
entering the food supply. People in three admit it\'s going to get in
the food supply. There\'s a different premise there. So, then when you
can\'t contain it but it\'s still going to get there. So, humans are
infallible.

MS. DILLEY: Does that capture \-- ssh! So we don\'t have to stay here
till 6:00 let\'s try and pin this down.

DR. HUNT: Aspects. That\'s what I\'m uncomfortable with in group three.

DR. LAYTON: I\'m sorry, I can\'t hear you, Josephine.

DR. HUNT: It\'s the tolerance, I think you mentioned.

DR. LAYTON: Allowances.

DR. SCHECHTMAN: I think again that there\'s more than one group. There
are two different group threes here. And I think that we\'re having
problems talking about this because the things that you\'re saying, Jo,
are different from the things that Greg and Jerry are saying so I think
when each of you refers to as \-- refers to group three you have to
acknowledge \--

MR. SLOCUM: Just refer to us as the practical, rational group.

DR. DYKES: I think that, Michael, to follow on your question. I think I
agree with you. I think the differences falls out in those that think
they\'re in group three as to whether you can have a tolerance for it or
not. I think Josephine doesn\'t want a tolerance. I\'m not sure where
Greg is, if he wants a tolerance for PMP\'s or not.

MR. JAFFE: And I don\'t think \--

DR. DYKES: I want the tolerance that meets those established food safety
standards. I know you do. I\'m not sure Greg is going to go along with
the tolerance for PMP\'s in food.

MR. JAFFE: I want a food safety review, the same, and if that turns out
to be a tolerance, it may turn out to be a tolerance. It may turn out to
be they\'re safe and it may turn out to be they\'re not safe then we
shouldn\'t grow them at all, but, I do want a food safety.

DR. DYKES: So you may be on the same place.

MR. JAFFE: I think we are. I think if we could work on language. If her
only concern is the word tolerance I don\'t think we need to have that
word in there.

MS. DILLEY: Safety review.

DR. HUNT: The safety review and containment.

MR. JAFFE: Right.

DR. HUNT: These are the things I would like to see in group three and
also, you know, the preferred use in the food.

MR. JAFFE: Right. I think group three has four characteristics. One,
preference for non-food crops. Two, a realization that these will get in
the food over time. Three, if food crops are used. And three, that
additional regulatory food safety.

DR. LAYTON: Okay.

MS. DILLEY: Mardi?

DR. MELLON: I think it is reasonable to articulate that as a kind of
comprehensive approach. I mean, it\'s not \-- I wouldn\'t agree with it,
but, I do think Brad needs to be \-- I mean, what I\'m hearing from Brad
is something quite different. He really believes that in many ways one
does not need an ultra \-- we don\'t really need an ultra effective
containment because you can address the issues of the kind of
contamination that might occur by setting tolerance.

DR. SHURDUT: No, I\'m actually not. I\'m more following on the
containment being in the primary system. In certain applications you can
rely a hundred percent on containment to do the job with certain
applications. As a fail-safe, different type of scale of application you
then need to have a tolerance in place as a risk management tool should
it get into the food supply.

So, I am in support of \--

DR. MELLON: But, it\'s not a fail-safe if you have a hundred \--

DR. SHURDUT: I am supportive of a food safety evaluation for certain
applications if the regulatory system cannot be controlled, adequately
be controlled in the system.

DR. MELLON: Well, what would you say about those things that cannot be
hundred percent controlled like any large-scale uses, industrial crops?

DR. SHURDUT: It goes through the food safety process.

DR. CRAMER: No, I don\'t think that\'s totally correct.

DR. SHURDUT: No. No. Cost containment. Containment bothers me. It\'s the
first step.

DR. LAYTON: Carole.

DR. CRAMER: You can change the language. The language down there is not
the right language.

MS. DILLEY: Right. It\'s not, but, \--

MS. ZANNONI: The safety assessment.

MS. DILLEY: We\'re trying to pick up certain applications. It\'s not
just all these products. There\'s some dimension to certain
applications.

DR. CRAMER: We can say it will be effective.

DR. SHURDUT: In certain applications.

MS. DILLEY: Okay. Regulatory oversight and appropriate industry
standards can \--

DR. SHURDUT: In certain applications.

MS. DILLEY: \-- in certain applications will prevent these products from
entering \--

DR. CRAMER: No, no. If you put in certain applications there it weakens
that hugely. What you want to do is to say that adequate regulatory
oversight and appropriate industry standards will be effective and will
prevent these products from entering the food supply in certain
applications.

MS. DILLEY: Okay. These products from entering the food supply in
certain applications?

DR. CRAMER: I don\'t know if I like that.

MR. SLOCUM: You\'re going to be with us before it\'s over. If you\'re
going to agree with us, come on over now.

MS. DILLEY: Isn\'t it be effective in certain applications in
preventing?

DR. VAN EENENNAAM: Certain situations?

MS. DILLEY: I hear it \-- I just think in certain things you think food
crops are appropriate because you can contain them is basically what
you\'re saying. So, it\'s a qualifier in that and some.

DR. CRAMER: Adequate regulatory oversight.

DR. VAN EENENNAAM: What if you just took out the last three words?

(Discussion off the record)

DR. CRAMER: Just go back to what it was before.

MS. DILLEY: It\'s back. That is it. Other members believe that with
regulatory oversight and appropriate containment systems will prevent
these products from entering the food supply. These products is hanging
me up.

MR. JAFFE: Medical and industrial compounds produced in food crops.

MS. SULTON: The question is does it move independently of the crops.

MS. DILLEY: The way it sounds is all medical and industrial products.
I\'m hearing Brad \-- maybe I\'m making them up \--

DR. SHURDUT: If you do large scale industrial work you\'re not going to
be able to keep it out.

DR. CRAMER: Then there is a situation where you if you don\'t then
you\'d agree that there would be a situation where \--

MS. DILLEY: Okay. So, everybody\'s different perspective is up here in
these three things?

DR. SCHECHTMAN: The third one needs work.

MS. DILLEY: I thought we worked on the third one.

DR. SCHECHTMAN: No, no, no, no.

MS. DILLEY: Okay. So, still another group preferring the use of non-food
crops in such products believes that if food crops were to be used
appropriate allowances for meeting established food safety standards
remain then federal regulations could provide for food containment and
food safety assessment.

DR. LAYTON: I think what you all said was you didn\'t like the
appropriate allowances for meeting established food safety standards
remain. I think what I heard you wanted to say was and that they meet
established food safety standards. If food crops are used they have to
meet established food safety standards.

MS. TUCKER FOREMAN: That needs to be a little more precise though. It\'s
the transgenic organisms in the food that need to meet.

MS. DILLEY: You need to go back to those three things.

MS. TUCKER FOREMAN: And I agree but I think that\'s what you mean.

MR. JAFFE: It\'s that last sentence below it that\'s just starting
there. You need to acknowledge it was there before and a little farther
down what you want to say is this group prefers that food crops not be
used but also acknowledges that it is impossible to guarantee the
absolute presence of \-- but, if food crops are used the system needs to
acknowledge that it\'s impossible to guarantee the absence of a
particular substance in \-- \-- quantities.

DR. LAYTON: You\'re right.

MR. JAFFE: And, so, instead of taking the first part of that previous
paragraph saying we prefer not to have food crops, but, if you use food
crops one needs to acknowledge \-- this group acknowledges that they are
going to get in to food in the long term and, therefore, you need to
have food safety assessments and containment.

So, that\'s, you know, whether you use the word allowances there or
whatever, but, that\'s the gist of it is prefer not to use food crops.
If you use food crops this group acknowledges it is going to get into
the food supply and you need to have additional regulatory steps,
including food safety analysis.

DR. HUNT: If they\'re ever going to review potential food safety issues
and stringent safeguards to prevent intermingling.

MR. JAFFE: That\'s right. There you\'ve got it. Josephine has it.

(Discussion off the record)

DR. SCHECHTMAN: Ssh! Ssh!

DR. HUNT: First it was, as Greg mentioned, that this group prefers the
use of non-food crops to be used whenever possible. And then their
recognition of \--

MR. JAFFE: If food crops are used, that\'s right.

DR. HUNT: If food crops are used there\'s a potential to get inadvertent
mixing in the food feed supply.

MR. JAFFE: I like that. The one below is an acknowledgment that it\'s
going to \--

DR. HUNT: You\'ve worded that better. And then that no food crop should
be used without looking into the review of the potential food safety
issues and the establishment of stringent safeguards to prevent
intermingling with the food feed supply.

MS. DILLEY: You better put that on there. Do you have that written down?

DR. CRAMER: Actually, I want to ask the group a question. So, is what
group three is asking, is that if anybody wants to grow a PMP in any
food crop they have to take it through the food safety system as well as
the FDA system? Do you have to go through a full regulatory review?

MR. JAFFE: Yes.

DR. CRAMER: For any PMP?

MR. JAFFE: Yes.

DR. SCHECHTMAN: Or any PMP in a food crop.

DR. CRAMER: If it\'s in a greenhouse?

DR. SHURDUT: How can you be sure it\'s in a greenhouse?

DR. HUNT: Yes, yes, because the premise is we say it could be.

UNIDENTIFIED MALE: So the answer is yes.

DR. MELLON: I\'m wondering if the second group ought to be confined to
small scale production. Some people believe that it is \-- that with
stringent regulations you can completely prevent contamination of the
food supply resulting from small scale productions because I don\'t
think there\'s anybody who believes that you could have large scale
production and completely prevent contamination or whatever word we
choose to use. I just don\'t think there\'s anybody that would sign on
to that.

You might be able to obviate the results of that by doing the food
safety review but nobody believes it can be done. I mean, I don\'t
believe it can be done.

MS. DILLEY: I don\'t know. If you just modify the second group to say in
small scale production some members believe that you can contain it.

MS. TUCKER FOREMAN: Does that reflect what they think?

MS. DILLEY: I don\'t know, Carol.

MR. JAFFE: I think we should stick with what the groups described the
way they want to describe themselves. If the second wants to do that,
that\'s fine, but, I don\'t think if you\'re not in that second group
you should tell them they should practice it that way.

MS. DILLEY: Let\'s make sure.

(Discussion off the record)

DR. LAYTON: Jerry, since Greg left, can you look at what\'s up here now
and feel comfortable with where we are?

MR. SLOCUM: I can get a lot closer and see it better.

DR. LAYTON: Okay. Still another group prefers the use of non-food crops
for certain products.

MS. DILLEY: It\'s being edited because Josephine\'s putting the language
in.

DR. HUNT: I left the last sentence there.

MR. SLOCUM: Put another qualifier on it. She\'s working on that, I can
tell you. She\'s a reluctant member of my group.

MS. DILLEY: Okay. So, do you want to start with this one and make sure
we\'ve just got it pinned down tomorrow?

DR. VAN EENENNAAM: Let\'s wait two minutes and get it finished.

MS. DILLEY: Because people have left.

DR. LAYTON: Well, only Greg and he and Jerry are in final agreement.

DR. SCHECHTMAN: And Randy.

DR. LAYTON: Okay. We\'ll go back over it but let\'s see if we can\'t pin
it down. Still another group prefers the use of non-food crops for such
product. However, they acknowledge that if the crops are to be used
it\'s impossible to guarantee the absolute absence of such substances in
the food supply. Therefore, no food crop should be used without thorough
regulatory review of food safety and the establishment of stringent
safeguards to prevent intermingling with the food supply.

DR. SCHECHTMAN: I just have one suggestion on that. I don\'t think \-- I
think they\'re not acknowledging that, they believe.

DR. LAYTON: They believe that.

DR. SCHECHTMAN: However, they believe that \--

DR. LAYTON: I agree.

DR. SCHECHTMAN: And without the however.

DR. VAN EENENNAAM: I wonder which they consider no food crop rather than
just having that sentence on its own because it almost sounds like \-- I
don\'t know, you just read that. If it\'s clear that that\'s that
group\'s opinion rather than a statement that\'s kind of in the text so
they consider that no food crops.

DR. SCHECHTMAN: In their view.

MS. DILLEY: Okay. So we\'ve got the three particulars.

MS. TUCKER FOREMAN: The second group just so we can see what it says in
there.

MS. DILLEY: Other members believe that adequate regulatory oversight and
appropriate industry standards will prevent medical and industrial
products from entering the food supply.

MS. TUCKER FOREMAN: And the first one?

MS. DILLEY: One group of committee members believes that the Federal
Government should not approve the use of food crops for the production
of medical and industrial substances even if the substances are safe
because no regulatory process or containment system can assure that
these products will never enter the food supply.

MS. TUCKER FOREMAN: I think it may say even if the substances are deemed
safe. Okay.

MS. DILLEY: Okay. All right. So, hopefully, this is just a review and
done tomorrow morning.

DR. SHURDUT: On the second one again, just getting back to that one
before we close.

MS. DILLEY: Okay.

DR. SHURDUT: Shouldn\'t we put in something about for certain
applications but I don\'t want to be dogging this point, but, the
possibility \--

DR. CRAMER: Let\'s just the three of us get together.

MS. DILLEY: Do you want to come with language tomorrow then and we\'ll
put that in first thing and then we can go through it. Okay. All right.
Excellent work, everybody.

Let me tell you where I think \-- so I just want to note that we\'ve
done 1, 6, 7, 10.5, 16, 18, and almost all the way to 14. You can take
that out tomorrow. I think we need to do 19, 20, 21, 23.

DR. LAYTON: 23 you\'re already looking.

MS. DILLEY: Right. 19, 20, 21, 23, 25, and then I\'m not sure about 26,
27, 28 only because they\'re relatively \-- they\'re comments but it
wasn\'t for a particular language. So, Mardi said if she had alternative
language she\'ll bring it. Those may be \-- it depends on where she is
in terms of giving her comments if she has suggestions for change and
she may or may not.

So, I would say then that it\'s 19, 20, 21, 23, and 25.

DR. SCHECHTMAN: And we\'ll go from there.

MS. DILLEY: Right. And then the other ones need to be touched on because
it\'s my assessment that most of the other comments may not be your
assessment that they were just editorial so we need to touch on some of
these other ones. I missed 22. Is 22 one that you all would like to have
on the list? Okay.

MS. TUCKER FOREMAN: I\'m curious about the basic differences I think
about that one.

MS. DILLEY: Okay. So, 22 then add. So, it\'s 19, 20, 22.

DR. CRAMER: I thought there wasn\'t that much disagreement on 22.

MS. TUCKER FOREMAN: Okay. I\'m sorry, I made

the \--

DR. LAYTON: I thought it was your editorial comments were about it.

MS. TUCKER FOREMAN: Okay. Sorry.

DR. LAYTON: And I didn\'t think they were substantive but I could be
wrong, Carol.

MS. TUCKER FOREMAN: I may be just have lost it because of the turn.

DR. LAYTON: We\'re off the record. We\'re adjourned.

(Whereupon, at 5:25 p.m., the meeting was adjourned to reconvene on
Friday, January 6, 2006 at 8:30 a.m.)