UNITED STATES DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C.

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--x

:

ADVISORY COMMITTEE ON :

BIOTECHNOLOGY AND 21ST CENTURY :

AGRICULTURE (AC21) :

NINTH PLENARY MEETING :

:

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--x

A meeting in the above-entitled matter was held on Wednesday, August 10,
2005, commencing at 8:30 a.m., at Loews L\'Enfant Plaza Hotel, Ballroom
D, Washington, D.C. 20036.

Dr. Patricia Layton, Chairperson

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

[Page]{.underline}

Bernice Slutsky, USDA 147

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

DR. LAYTON: Now I think we can start on the record.

MS. SULTON: We would like to go over the dates and have you all check
your calendars. So, if you could pull your calendars out we\'ll look at
the dates for our October and December meeting and see if it continues
for most everybody.

Again, the dates we were looking at were in October for the 24th to the
25th and in December, between the 13th and the 16th, those dates seemed
initially to look good. So, if you could take a moment and let us know.

DR. LAYTON: There\'s really not an option on the 24th and 25th date.
It\'s really which dates the 13th and 14th.

MS. SULTON: Okay. Actually, to be fair to you, we really don\'t have any
options in October so we just want to count and make sure that who is
available.

UNIDENTIFIED MALE: I\'m sorry, I don\'t quite understand.

MS. SULTON: Okay. Well, it turns out the Chair is limited in her
availability in October, okay. We\'re not being mean and nasty. The
24th, 25th, is that going to \-- is there anybody for whom that will not
work?

DR. LAYTON: Besides Dick.

DR. SCHECHTMAN: Besides Dick.

(Discussion off the record)

MS. SULTON: Won\'t work for Brad. Brad and Dick. What about the week of
the 13th of December, how does that look on your calendars, between the
13th and the 16th?

(Discussion off the record)

MS. SULTON: Alison and Carole Cramer.

(Discussion off the record)

DR. SCHECHTMAN: We did the dates of the 24th and 25th of October. We
just mentioned those. We\'re looking to have two meetings to be able to
finish.

MS. SULTON: WTO conflict for Leon, Michael, and Dick. And Dick already
missed the meeting.

(Discussion off the record)

DR. SCHECHTMAN: We\'ll have to revisit the December dates but other
parts of December did not look very good.

(Discussion off the record)

DR. SCHECHTMAN: The complication is, you know, there are basically two
weeks to try to do stuff in December so I\'m not quite \--

(Discussion off the record)

DR. SCHECHTMAN: I think the issue in part was not being able to turn
around transcripts and all of the rest of the meeting. As it is, this is
five or six weeks and that\'s mighty short.

(Discussion off the record)

MS. SULTON: Unfortunately, we need the transcripts to develop the
document.

(Discussion off the record)

DR. SCHECHTMAN: Abby just mentioned the 19th and 20th of December.

(Discussion off the record)

MR. JAFFE: I mean, is the worry about trying to have a meeting in
December trying to get the document done in December? I mean, having a
meeting even the 13th to the 16th, given our last experience, we still
want people to look at the document and get a chance to review it, which
will be over the Christmas time when people wouldn\'t have a chance to
do that anyway.

So, I mean, I don\'t \-- I mean, even having a meeting December 13th
through 16th, the proposed dates, wouldn\'t get a document to the
Secretary\'s office before December 31st so we wouldn\'t meet that
deadline with a mid-December meeting as it is given the fact that people
have to turn around a document, have a chance to look at that over a
time period that most people aren\'t in the office.

So, it seems to me, therefore, to rush and try to have that meeting if
people aren\'t doing it, waiting till January isn\'t a problem because
we wouldn\'t get the document to the Secretary anyway in December even
if we had a meeting during that time.

DR. SCHECHTMAN: Okay. If the group is okay with the thought of holding
the meeting, say, the first week in January. We haven\'t taken
everyone\'s schedule yet so we\'ll just have to see.

(Discussion off the record)

DR. SCHECHTMAN: We\'ll take a second and try to pin it down, but, I just
wanted to check on one thing, that our intent is to finish all of the
full committee work on \-- to have the last meeting discussing this
document in plenary session as that meeting in January to having the
deadline much as we had for the other reports. So, that would be the
intent.

MS. SULTON: That housekeeping done \--

DR. SCHECHTMAN: Oh, no, I don\'t think we\'re quite done yet.

MS. SULTON: No?

DR. SCHECHTMAN: We have folks here. If everyone has their calendars we
might actually try and see if we can pin down January dates and spend a
minute or two doing that.

(Discussion off the record)

DR. SCHECHTMAN: How about January 5th and 6th? Let\'s see how many
people can\'t make the 5th and 6th. Cannot.

(Discussion off the record)

DR. SCHECHTMAN: That\'s actually having only one person who can\'t do it
at this point is pretty good so with all apologies that sounds like a
pretty good pair of dates. Should we tentatively plan on January 5th and
6th? Thank you.

(Discussion off the record)

MS. SULTON: Okay. What we were hoping we could this morning is get
through the rest of these topic statements and then we\'ll work on a
work plan for getting the document completed for review in the October
meeting and finalization in the January meeting.

So, if we could start with issue number 7 on page 6 and the topic
statement is, the regulatory system for plant derived products not
intended for food or feed use must ensure appropriate \-- I skipped one,
sorry. Disregard.

The trend towards local efforts to impose additional regulatory burdens
on ag biotech products will have impacts on agricultural biotech. So,
the issue is the local laws.

MR. OLSON: I agree.

MS. SULTON: Ron?

MR. OLSON: I agree.

MS. SULTON: There\'s a statement of agreement with the statement from
Ron. Any \-- is it clear? The question is, do we understand what we mean
by that statement and do we \-- or does it need any further explanation.
Brad?

DR. SHURDUT: Yeah, the only minor comment here is local could be local
anywhere around this world so I think they\'re assuming like state and
county or state and local initiatives, so, maybe there\'s a bit of just
a bit of clarification there.

MS. SULTON: Say domestic?

DR. SHURDUT: Domestic will be fine, or, you know, state and county, you
know, initiatives, or, however you want to put it.

MS. SULTON: Any other comments? Greg?

MR. JAFFE: I guess in the discussion on the issue, I mean, again, what
we would want to put about it, I mean, I think I sort of understand the
issue, but, again, I would want to make it clear whether we\'re just
talking about local or State and local. I think we\'re probably talking
about a State and local, not just local.

I guess I\'d want to talk about what is additional regulatory burdens.
I\'m not sure moratoriums are regulatory burdens. They just prevent \--
I mean, they don\'t add regulatory burdens. They just say we can\'t \--
you can\'t have it in this situation, so, I\'m not sure if we\'re
talking about moratoriums here, or, we\'re talking about additional
regulatory requirements such as a permitting requirement by the State of
California, or, a Rice Commission requirement in the State of
California, or, permitting requirement in Missouri, or, whatever it is.

So, I think we just should be clear about what we\'re talking about
because I think they are different things. We might want to talk about
both of them, or, we might just be talking about one or the other.

And the other thing is, I mean, this was written a year ago and I think
maybe a year ago there was more of a trend towards doing this. I\'m not
sure there is a trend or not. I\'m not sure we want to opine then,
whether there\'s a trend or not. We could talk about the fact that there
have been some of these, there will be more in the future, may be more
in the future. I don\'t know whether we want to opine as a group as to
whether or not we could get trends increasing or decreasing.

The latest stuff in California suggested a lot of these are being voted
down and, in fact, they may not be something that is continuing in a
larger effort. Some of them may be continuing for very specialized
things such as pharmaceutical crops, but, they may not be happening for
the more commodity crops and things like that.

So, I agree with the issue. I think it\'s a very important issue to
discuss. I think we just need to flush out with a little more
specificity about what we\'re talking about in a couple of these ares
when we get to the drafting stage.

MS. SULTON: Okay. Alison?

DR. VAN EENENNAAM: This is an issue I\'m intimately familiar with having
come from a state that\'s drafted a lot of these and although three of
them were voted down last year, three of them have been approved. These
are county-based bans effectively on GE. There\'s one coming up in
November to ban all genetic organisms in one county and some of the
counties are talking about additional regulatory burdens such as go
through a county-by-county permitting process whereby a group of experts
in the county will evaluate whether these products are safe and okay to
have in that county.

And, so, I think there is the potential there if anything like that did
get approved that there could be additional regulatory burdens. And, to
Bradley\'s point about this just being county and state based or an
American thing, I think, and correct me if I\'m wrong, Josephine, but,
there are some talk of GE-free zones in Europe and, so, I don\'t think
we should narrow it down to just counties when it\'s potentially just
any local effort that could put additional burdens on it.

MS. SULTON: Josephine?

DR. HUNT: Yes. Just to confirm, there are some member states of the EU
which essentially do ban GE products.

MS. SULTON: Are we talking about the states of nations or locally?

DR. HUNT: I believe, I want to say member states, I mean, a country. For
example, Luxembourg is one of those countries.

MS. SULTON: Dick?

DR. CROWDER: I don\'t know where we want to go with it, but, just to add
to what has just been said about Europe, Chile has some of the same
restrictions in terms of GE-free zones because of their off-season seed
production. They have a number of GE-free zones and they worked with the
co-existence regime down there that works, but, it\'s \--

MS. SULTON: Greg?

MR. JAFFE: I mean, I guess I\'m not uncomfortable going on to the
international level for this discussion unless we\'re going to talk
solely about moratorium-type situations because you have \-- when you
start talking about state and local and things like that you get very
different kinds of governmental structures.

India, for example, is a very different kind of governmental structure
than the United States and, so, things are delegated in different ways
into what we would consider federal might be considered equivalent in
some of those countries and we start talking about Luxembourg, well,
what about Zambia or other countries that just as countries, as
sovereign entities, at national levels are banning or doing something.

So, if we want to have an issue about bans of moratoriums or bans on GE
in geographic areas I think that would be fine, not to be global if one
wanted to do that. But, if one wants to talk about regulatory burdens
and regulatory requirements and starts talking about national versus
state versus local those terms have specific meaning in the United
States and have very different meanings in different countries around
the world and Luxembourg is a \-- I mean, it\'s a national \-- it\'s a
country.

So, you sort of start mixing things that I think are wrong and we don\'t
make the point we want to make, I think. So, you want to talk about
additional regulatory burdens, I think we should limit that to state and
local levels in the United States. If we want to talk about moratoriums
or something like that, or, bans and make it a global thing I think one
could word it that way.

But, I think to mix them up, I\'m uncomfortable understanding the
different political systems and different state, local, federal means
very different things in different parts of the world.

MS. SULTON: It appears that the original text was talking about
conflicts, that there will be a conflict between having laws that have
been built at the federal level and state and local level.

Michael? Abby?

MS. DILLEY: I don\'t think people had a problem with maybe splitting
those topics. It just seemed that there was a lot of nodding in terms of
there are different points and one\'s kind of patchworked domestically
but the other is moratoria or bans internationally. So, I think those
issues could be split without too much trouble.

MS. SULTON: Okay. Michael?

DR. DYKES: Yeah, I think they\'re two different issues as well. I think
when we originally had this we were talking about counties in California
and some of the local town meetings in New England. I think we were not
necessarily thinking about states when this was originally brought up, I
mean, specifically to the California counties. And I\'m kind of where
Greg is. I think there are two different aspects here.

One is the local political subdivisions in the U.S. about restrictions
of various types and then the other one is the international scene in
terms of countries and different things in different countries.

MS. SULTON: So, is the consensus that both should be addressed or just
the \-- both should be addressed, okay. Anything else on this topic?
Dick?

DR. CROWDER: I just want to say that I am comfortable with leaving the
word trend in there because our experience in terms of member states
with different state laws affecting this. Our activity last year in
terms of watching things come through was greater than it was the
previous year which was greater than it was the year before that.

So, it may in the future, but, right now I\'m comfortable with \-- it
may change in the future, but, right now I\'m comfortable with the word,
trend, remaining in there.

MS. SULTON: Anything further on this topic? The next topic which is
number 6, the regulatory system for plant derived products not intended
for food or feed use must ensure appropriate containment and the safety
and integrity of the food feed system. Are we okay with that stating the
issue as we understand it? Any comments or need for expansion? Greg?

MR. JAFFE: I just want to clarify. I mean, I think that that is a
summary of the issue, not the statement of the issue because, again,
these were sort of watered down statements because we were trying to
have them as the bullet point and then there would be discussion
explaining it.

So, I think I understand the issue. I\'m comfortable with the issue. I
think it\'s a topic that should be discussed, but, I wanted to just,
based on what you just said, I just wanted to clarify how we\'ve been
going about this yesterday and today that that\'s by no discussion here
that doesn\'t mean that we\'re just going to keep those 15 words and
that\'s a description of the issue; we\'ll set up a work group or
whatever that\'s going to put together the short topic explanation of
that topic.

MS. SULTON: When we were talking about it yesterday we were thinking
that, again, to keep it balanced we\'d probably have three or four
sentences for each of these. Anything further on this topic?

Topic 5.

DR. LAYTON: Wait. Carole.

DR. CRAMER: Just in \-- just to throw it out on the table. I don\'t
think that the regulatory system through the USDA essentially ensures
the safety. I mean, anything that you would be writing for containment
of PMP\'s is not going to be something. I think the focus should really
be on the integrity and the lack of commingling.

It seems to me that if you put an onus or if you\'re suggesting that the
onus for food safety is on PMP regulations that you\'re mixing apples
and oranges. The whole idea is that you\'re ensuring the integrity of
the food system in these non-food products.

MS. SULTON: Greg?

MR. JAFFE: If I might respond to that, I guess I read regulatory system
as not limited to USDA at all, but, also would include FDA. And, so, I
do think food safety is paramount and I think we are saying that one of
the issues is ensuring that PMP\'s are both contained and that they
don\'t have a safety impact on the food supply.

My reading of this was, it wasn\'t limited to APHIS or USDA\'s
regulation. That\'s why in our discussion we would spell that out.

MS. SULTON: Any \-- go ahead, Michael.

DR. SCHECHTMAN: Can I see if I\'m understanding some part of this? Is
part of what you\'re saying, Carole, that the onus can\'t be on
regulations specifically for plant derived pharmaceuticals to ensure the
whole safety of the food and feed system? I mean, there is the safety
aspect with respect to these things entering the food supply, but, it\'s
not their responsibility to deal with all of the other aspects of food
safety that don\'t have anything to do with the plant derived
pharmaceuticals.

There are many aspects to the safety of the food and feed system that
have nothing to do with the presence or absence of plant-made
pharmaceuticals and the way this statement reads, it\'s reading as if
plant made \-- regulations for plant made pharmaceuticals are
responsible for all aspects of the safety of the food and feed system.

MR. JAFFE: And I agree with you there, but, I do think that we are
talking about the safety of the food and feed system as related to the
plant made pharmaceuticals and that is not limited to the purview of
USDA.

DR. SCHECHTMAN: No, there\'s no disagreement.

MR. JAFFE: Okay.

DR. SCHECHTMAN: I was just trying to see if I was capturing what
Carole\'s point was.

MS. SULTON: Michael?

DR. DYKES: Yeah, I understand what you\'re saying that the regulation
with PMP can\'t be held accountable for all aspects of the food system.
I think that\'s what you\'re saying. But, I don\'t think that\'s what
the statement says. I think the statement is talking specifically about
those products, so, naturally I think the statement\'s limited. I think
it\'s accurate. I mean, you can\'t say that somebody does something
unrelated to PMP\'s in the food supply that all of a sudden it\'s not
safe, therefore, it\'s the responsibility of the PMP regulations.

I don\'t follow the \-- I agree with what you said. I think it\'s a true
statement, but, I don\'t understand what it\'s applicability is here.

MS. SULTON: Pat?

DR. LAYTON: I think in reading this statement it\'s grammatically
incorrect and it does do what Carole said it does. I think it\'s a
grammar issue. And it can be easily fixed.

DR. DYKES: That\'s probably why I missed it.

DR. LAYTON: I think it\'s just not grammatically correct and I think it
does \-- if an English teacher, you know, the fifth grade English
teacher read it she would say you\'re making it take care of E. coli
too. So, it\'s not doing that and it\'s just grammatically incorrect and
needs to be changed.

MS. SULTON: Okay. Any further comments on this topic? Number 5.

MR. JAFFE: Wait.

DR. SHURDUT: Yeah, just one quick comment. In terms of the clarification
maybe you can do this in the subsequent sentences. There are plant
derived products that will come about in vitro in the laboratory. So,
how do you make this sort of field produced, you know, plant derived
products? Because there will be cell culture work with plant cells and
they\'re called plant derived. And I think we\'re talking about the open
pollinated, open field production.

MS. SULTON: Noted. Carole, did you have your card up or no?

DR. CRAMER: No. Sorry.

MS. SULTON: Okay. Topic 5. There is no comprehensive federal regulatory
system that will assess the environmental and food safety of transgenic
animals before they are commercialized. Michael?

DR. DYKES: I guess just one of the comments on this whole animal thing.
I think the committee needs to have a discussion about \-- maybe I\'m
the only one that\'s somewhat confused about the animal side of things.
Are we going to talk about animals, transgenic animals, or, are we going
to defer that to another time?

And I simply ask the question because, in my view, most of this
committee, speak for myself, focused primarily on the plant side and not
the animal side. So, I\'m not going to be giving the best advice as to
what the animal regulations are because I just \-- I don\'t do them all
the time and I\'m not saying that there shouldn\'t be a look at that and
I\'m not saying anything about the statement.

I\'m just asking the procedural question, are we going to talk about
animals and, if we are, are there any boundaries that we\'re going to
talk about it, or, should we put the animals to a whole different group,
maybe a different makeup of a different committee that has people that
are as much animal as this committee is plant?

That\'s the question I ask.

DR. SCHECHTMAN: Let me respond to that in part having to do with the
initial charge to the committee. The initial charge addressed both
plants and terrestrial livestock animals. Certainly we recognize that
the focus of this committee is largely plant-based, plant-derived.
That\'s right. But, we think that certainly to the extent that this is a
very general identification of very broad issues and is not, you know,
the more \-- a more comprehensive look at some animal issues, we think
that this is perfectly fine within this purview.

Now, your point is certainly well taken and I think one of the reasons
\-- we\'ll come back to this later \-- that an issue having to do with
animals was suggested on the new work list as being a little bit down
the road is our recognition of our need to perhaps augment some of the
expertise along those lines on the committee before we have those
lengthy discussions.

But, I think I\'ve presumed that this was going to be there. Without
putting words in anyone\'s mouth I presumed that it was within bounds.
I\'ll put it that way.

MS. SULTON: Carol?

MS. FOREMAN: Yeah. I think that, in fact, there are a number of people
on the committee, including some of the new members, who deal with
animals. Alison, Daryl deal with them. Greg, and Mardi, and I regularly
deal with these issues. I think it\'s a very big issue for Kraft. So, I
think there may be more interest and expertise than a quick look might
indicate and certainly I think we should leave that open because it was
part of the initial charge.

And had I read the initial charge as excluding animals I probably
wouldn\'t have accepted appointment to the committee. I took the words
that were on the paper.

MS. SULTON: Yes, Michael?

DR. DYKES: Carol, I didn\'t mean to in any way make any accusations
about anybody\'s expertise on the committee and I recognize you, and
Greg, and, obviously, Alison and others. But, I was just talking more
generically to the committee that I thought by and large most people
were plant-based.

MS. FOREMAN: I think I listed about 40 percent of the committees in the
names that I\'ve ran through there.

DR. DYKES: Okay.

MS. SULTON: Bob?

DR. HERDT: Yeah, I would only say that as a topic, as a statement it
seems to me that this is an important statement to keep in.

MS. SULTON: Pat?

DR. LAYTON: My only question is should this be qualified \-- what\'s the
proper term? Is it food animals? We use that and some write-up that we
had earlier. Are we worried about all animals, or, is it food animals?
So, is that the right term, transgenic food animals versus transgenic
animals? And I didn\'t know the right answer. Someone had asked that as
a question.

MS. SULTON: Alison?

DR. VAN EENENNAAM: I guess I\'ll follow up which was a question I had
which someone just popped in there, terrestrial animals, and I was
curious, is that actually the written charge of this committee? I mean,
the first product going through is a fish.

DR. SCHECHTMAN: It\'s not the charge to the committee as a whole. It was
the charge that was agreed to by the committee for the writing of this
report. So, it was always conceived that it was possible that there
could be a subsequent report dealing with some of the other critters
that this report wouldn\'t be discussing. Yeah?

DR. VAN EENENNAAM: Going to Pat\'s point then, if we\'re going to say
that it\'s terrestrial food animals then that eliminates both glowfish®
and Aqua Bounty® salmon which are two products that have already
approached market or going through the regulatory review process that
seem to be very in the purview of the next five to ten years in
agricultural biotechnology.

DR. SCHECHTMAN: Let me just add two sentences and then I\'ll \-- I
don\'t think I would have a particular problem with leaving it, with not
making the distinction between terrestrial and not in this description
of transgenic animals since it would be essentially a big chunk of it
would be the same regulatory system at least.

I don\'t know that \-- I don\'t know how members feel about it, but, in
terms of the fact that that might slightly expand what was talked about
in the report, I don\'t think that causes us special heartburn.
Obviously, it\'s not a report that\'s focusing on fish or insects or
trees. But, we recognize that the statement has a wider applicability,
but, that\'s just my view.

MR. JAFFE: I guess I would also agree with Alison that I think we may
want to rethink that limitation of terrestrial to include fish, I guess,
especially since we\'re talking about the next five to ten years. Those
are the most likely \-- some of the most likely transgenic animals to
come to market are fish.

And I think adding that additional small amount won\'t make a change and
I would also, to answer Pat\'s question, say that it shouldn\'t be
limited to food animal and the glowfish® is an example, so, I would not
limit it to food animals or animals for food. I\'m not sure if you were
making a distinction there.

MS. SULTON: Daryl?

DR. BUSS: On the other hand, I wouldn't leave it completely broad,
including any type of transgenic animals. You include every research
transgenic animal that\'s ever been created. That clearly was not the
intent of the statement. So, I\'m not sure what the right wordsmithing
is to do that, but, all encompassing would be a mistake.

MS. SULTON: Greg?

MR. JAFFE: I do think that \-- I mean, as I said before, they are
commercialized. I think what we\'re talking about, we could make that
clearer in the discussion that we\'re not talking about research stage,
but, talking about stages \-- regulatory systems towards
commercialization.

DR. BUSS: However, commercialization of research rodents, for example,
is also a reality.

MR. JAFFE: I don\'t disagree with you. I\'ve had this discussion with
you at FDA on numerous occasions where if you read the few statements
they have on transgenic animals and the legal authority upon which they
plan to regulate transgenic animals, that\'s right, rodents that have
been genetically engineered to answer whatever that are sold
commercially would fall under, in my reading would fall under their
regulatory system.

They have chosen to exempt those. Orally they\'ve told me that. I don\'t
think they\'ve ever made a formal decision about that, but, for some
reason they\'ve just never taken \-- they would say they\'ve never used
their discretion to regulate those. I\'m not sure as a lawyer you could
say that you can discretionally decide which things fall within your
legal mandate or not, but, you can exempt things, but, to discretionally
not bring them in, I don\'t know if you can do that.

But, anyway, they have made a choice to not include things like rodents
and that are genetically engineered at all and they\'ve required no
regulatory requirements at all for those to date. They have not
officially stated the basis for that, but, I\'m not planning on
including those in this.

MS. SULTON: Bob, did you still want to make \-- okay. Alison?

DR. VAN EENENNAAM: I guess just the charge of this committee is
agricultural biotechnology and, so, is that the distinction that we want
to make and, if so, that kind of takes glowfish® out of the picture,
which I don\'t know that everyone would be comfortable with. Are pets,
genetically engineered pets the purview of this committee, or, is it
agricultural animal?

MS. SULTON: Yes, Bob?

DR. HERDT: Well, it seems like it\'s a big issue. You know, I mean, we
could say, well, we\'re only supposed to deal with agriculture. What
we\'re pointing out is a lacuna here in the regulatory system that
affects Americans, you know, it affects everybody. The Secretary may not
be able to deal with it, but, you know, this is a big issue.

You know, potentially can find its way into the food chain. I mean, I
don\'t think we have to \-- we\'re not going to write a paper on this
issue, but, the statement that, you know, there\'s no regulatory \--
comprehensive federal regulatory system seems to be \-- I don\'t know if
that\'s an accurate statement, if it is an accurate statement.

MS. SULTON: Okay. Greg, Daryl, Leon, Carol.

MR. JAFFE: I mean, I was going to say that I\'ve looked at our charge as
sort of \-- that the Secretary is involved in lots of things related to
agricultural biotechnology and things that are going to affect things
that the Department does. And the fact is, glowfish® or other kinds of
animals might have huge impacts on transgenic plants, for example.

I mean, the controversy around transgenic animals may fall \-- may have
a side effect just like the controversy on human cloning may have an
effect on animal cloning. Even though they may be very different things,
they may have an effect because of the public perception and public
issues.

So, I look at our charges as looking at things that will impact what the
Secretary does related to agricultural biotechnology and I do think some
of these transgenic animal issues, including animals that are not
agricultural animals, will have an impact on what the is nationally or
internationally related to agricultural biotechnology.

So, I do see that in the purview for that reason.

MS. SULTON: Daryl?

DR. BUSS: Well, I guess conceptually I struggle with getting into what
could be even second or third order effects on the system. Just
simplistically looking at the title of this document it says future
impacts of biotechnology on the food and agricultural system of the
United States. So, unless our society is going to change substantially,
I don\'t see some of the examples that we\'ve talked about as being
terribly relevant to the food and agricultural system, which doesn\'t
solve the rewording, but, I think we need to define our thinking or
circumscribe our thinking toward that sort of goal.

MS. SULTON: Leon?

MR. CORZINE: Daryl summed it up pretty well because I had a concern. I
mean, you can pull these things out and get so broad that you end up
with a document that includes absolutely everything and we\'re talking
about recommendations for the Secretary or is this supposed to just be a
public document of statements?

I think we have to be a little careful because of this comes under FDA
now, right, although you want USDA to be involved, if that\'s what
we\'re saying. But, Daryl put it really well. You get so broad it could
become meaningless.

MS. SULTON: Carol?

MS. FOREMAN: I don\'t have really strong feelings about this, but, the
Secretary administers the Animal Protection Act which deals with
non-food animals, not the glowfish®, but, I think it\'s not
inconceivable that you will end up having agricultural animal,
agricultural biotechnology affecting animals that the Secretary might
well regulate under the Animal Protection Act.

So, for example, cloning. One use of animal cloning is to protect its
species that might become extinct and that might well fall under the
Secretary of Agriculture. I think, in fact, there\'s a big paper from
USDA about just how far the Animal Protection Act can be used in this
area.

So, I think it\'s not unreasonable. I would sure not like to get into
laboratory animals. I think that\'s \-- those are used for research.
They do seem to me to fall into a separate category that we shouldn\'t
try to get into.

MS. SULTON: Duane?

MR. GRANT: I think it\'s been pretty well said, although because of the
emotional cachet of animals we can get dragged out into the weeds there.
We\'ve got some real important issues that have the ability to pull us
into trade battles with folks. Glowfish® isn\'t one of those. I think we
have to apply the relevance test to what we spend our time on and we
have a hard time getting through what we set for ourselves anyway, so, I
guess Daryl said it well and I just wanted to chime in on that today.

There is a relevance test that we have to apply.

MS. SULTON: Michael, do we have enough for us to \-- Carol?

MS. FOREMAN: Can I just say one more thing quickly? Because Mardi Mellon
has to be on jury duty this morning let me just say I think Mardi would
probably make an argument that this is \-- that we shouldn\'t exclude
the glowfish® and she\'s not here, but, since her choice is they would
have come with the marshals and dragged her off if she hadn\'t gone to
court this morning. My guess is she would have suggested that was
something appropriate for us to do.

DR. SCHECHTMAN: Can I make a suggestion? And that would be a suggestion
that would go to a subsequent text in this. Judging from the
conversation that I\'m hearing now, my proposal would be that glowfish®
not be used as an example, but, at the same time agricultural organisms
be mentioned and also organisms under other USDA authorities such as the
Animal Protection Act, but, be alluded to that they are part of \-- that
USDA has some responsibilities in that area.

Would that be a solution that would accommodate everybody?

MS. SULTON: Greg?

MR. JAFFE: I don\'t have a problem not using the glowfish® as an
example. I don\'t want to limit this to \-- this discussion to only USDA
authorities when we\'re talking about the regulatory system overall
which is food safety and environmental.

DR. SCHECHTMAN: There was no intent to do that.

MS. SULTON: Thank you, Michael. The issue or topic number 4 at the
bottom of page 5. The FDA system for regulation of foods (feeds) derived
from transgenic crops must be adequate to ensure human safety and public
acceptance. Carol?

MS. FOREMAN: Yeah, it just seems to me that there\'s nobody at the table
that\'s going to dispute that particular statement. What gets said after
it is \-- it leaves us like this. In reading that statement I don\'t
think it begins to address the concern. You have to do something more
there.

MS. SULTON: Greg?

MR. JAFFE: I mean, I was going to say this was, again, a watered down
statement that we didn\'t agree to that was just an attempt to put a
heading for what was going to be a discussion. For the new people, who I
assume still know what this issue is, it\'s the issue of voluntary
versus mandatory pre-market approval for FDA and I think it\'s a very
big issue.

So, I think it is an important topic for the Secretary to be aware of.

MS. SULTON: Other comments? So, this one you\'re suggesting is going to
require a work group effort, correct?

MR. JAFFE: I mean, I would \-- I was going to make a comment after we
finished this discussion, but, I\'ll make it now in response to that. I
think that\'s the last four that we went through, we went through very
quickly. Everybody understands the topic. I think the work group has
worked for a year and a half trying to write those, both in small
amounts and in large amounts, and they were very difficult.

I think we\'re going to need work groups for all four. Not that we\'re
not going to need work groups for all of these, but, in particular,
these last four we went through in about 35 minutes and I think we
should not assume that the lack of discussion about those, at least in
my opinion, based on what we\'ve done historically in the work group, in
the issues work group is, that writing these, and I think all four of
these statements, again, aren\'t sufficient, but, putting them together
down.

And, depending on what our timing is today, we might even consider
getting some small groups today while we\'re in person and spending an
hour, four different groups, trying to write three sentences or four
sentences for each of these.

I don\'t know what our work plan is going to be, but, I think that I
wouldn\'t limit it to this one, a lot of these, in particular, since we
spent a little time on the last four discussing them, I think will even
be more important.

MS. SULTON: Okay. Well, we will, when we put together the plan shortly,
maybe at the end of this effort here, we will figure that out. Could we
look at the \-- I\'m sorry, Daryl?

DR. BUSS: Well, along that line, I was going to comment on it as written
because literally you would have to conclude that a system for
regulation, all regulations can ensure acceptance, and that\'s not
reasonable for anything.

MS. SULTON: Facilitate or encourage. We\'ll wordsmith that. Any other
comments on this topic? Okay.

The topic number 3, the coexistence of biotech production with various
specialty and commodity crops will be important. Dick?

DR. CROWDER: I don\'t know where to go with this one, but, I guess the
"will be" is an issue. I think it is and it always has been. I don\'t
know that the world has changed on this one with the introduction of
biotech. Crop corn and field corn, yellow corn, white corn, canola, red
seed and everything else, I\'m not so \-- I mean, co-existence has been
around.

I\'m not quite sure what we\'re \-- what\'s \-- what we\'re driving at
here that doesn\'t already exist.

MS. SULTON: Are there any other comments? Leon?

MR. CORZINE: I guess I would say in the final document, I don\'t know
how much you want to expand the statement, we can \-- I mean, everything
here is pretty much true, but, how much dialogue or verbiage do you want
under the statement or it\'s kind of a statement of the obvious.

As Dick said, this is coexistence, is nothing new. If you want a
statement that says, okay, it\'s important, okay, it\'s important, but,
I don\'t know what else it needs.

MS. SULTON: Well, to keep it to two, three more sentence will be chosen.
Any other comments? We\'re talking about the number 3, coexistence, on
page 4. Any further comments on this? Okay. Daryl? I\'m sorry, was it
Michael who raised his hand? Yeah, sorry.

DR. DYKES: I was just going to say I\'m kind of where Dick is. I think
maybe instead of will be it should be is important.

MS. SULTON: Okay.

DR. DYKES: A very minor comment.

MS. SULTON: All right.

DR. LAYTON: This is where I get to talk about trees. We may not have
biotechnology in trees unless we come up with a system that works. They
are long-lived perennials. We harvest them for not their fruit and
they\'re \-- you know \-- there is complicated regulations that we\'re
working through now with USDA to allow us to even test. Right now we
can\'t even test past flowering time.

And if they don\'t flower then we can\'t breed them and we\'re going to
be clonal and it\'s going to make a very complicated mess. And
coexistence is very difficult for us and it is \-- it will be an
international problem. We already know that we have trees planted in
China that are not sterile and, you know, wind carries and wind carries
pollen thousands upon thousands of miles.

So, it is an issue. I don\'t think we\'ve explored it. I don\'t think
this group has thought about it very much. It\'s thought about in the
circles I work in a lot and we don\'t know how bad, or, how good, or,
how easy it\'s going to spread. But, it is an issue and we have pretty
much stayed away from animals. We\'ve pretty much stayed away from
long-lived perennials also in the plant world.

But, this has tremendous implications for us ever, ever getting the
first crop in the ground. We\'ve been working on trees and round up
ready trees since 1985 and we don\'t have the first commercial product
yet. And until this time that things get solved we won\'t. So, we have
the number one commodity crop in almost 30 of the states. The number one
ag crop in almost 30 states cannot have biotech.

So, it is an issue.

MS. SULTON: Did you have a comment you wanted to make? Dick?

DR. CROWDER: Pat, I don\'t agree that it\'s not an issue. I think it is
an issue. It\'s just not a new issue. And the thing that I\'d like not
to see in the U.S. is what just recently happened in Spain where
they\'ve been growing biotech crops and have worked under the
co-existence system in the marketplace and it worked quite well and then
last week a whole new set of regulations was imposed from the top down,
from the federal government all the way down to the local on coexistence
practices.

And, you know, even though for ten years it\'s been working quite well
and it is an issue and always has been an issue, and I don\'t know the
problem with putting coexistence in, for us it\'s an issue in finding a
workable solution that\'s not regulated in terms of everything you do is
what we\'ve been looking for in a number of countries working on that.

The Dutch have probably done more than anyone else on it in terms of
getting acceptable solutions.

MS. SULTON: Any further comment? The number two topic reads as more
biotech events are commercialized globally the problem of asynchronous
approvals will become increasingly important.

MS. DILLEY: Just a couple of things on this one. Obviously, both two and
one are topics that were addressed to quite some degree in the
traceability and labeling so we want to make sure that we\'re not doing
something different than what we did in that report and also our
statements that are more generic, but, obviously had a lot of work done
by the work groups and conversation around these, so, I think we\'re
going to have to try and just fill out the gist of both those
conversations as well as make sure they\'re not running contrary to the
reports that have already been submitted. So, just to provide that
context.

MS. SULTON: Brad?

DR. SHURDUT: I guess the question here is just in terms of the statement
at the top over the issue. It\'s pretty obvious that you\'re going to
have problems with asynchronous approval, but, what\'s the issue here? I
mean, is it a trade issue; is it holding back, you know, launches or
commercialization of a product so it could delay launches?

So, I don\'t know if it fully articulates in one sentence or captures
the issue here. Is distinguishing approval just a process issue, but, it
doesn\'t articulate why we care about asynchronous approvals?

There\'s also a big piece of this which seems to be captured, or, could
be captured in the whole adventitious presence discussion if you had a
policy in place and you had it globally then it would diminish some of
the effects of asynchronous approvals. I understand that there\'s things
beyond that for asynchronous approvals, but, possibly a large part of
this issue is embedded within that first issue. It\'s not distinct and
necessarily separate.

MS. SULTON: Michael?

DR. DYKES: I would agree with Brad. I do think that a lot of this is a
subset of the adventitious presence.

MR. JAFFE: I\'d like to see them separately. I think they are two
different issues. I\'m not say that they don\'t overlap or have some
things, but, I do think that they are different issues and, so, because
one\'s talking about adventitious presence can be both non-approved
events, but, also approved events whereas asynchronous approvals really
deals with unapproved events, not dealing with approved events.

So, I mean, I think \-- I understand that there is a subset where they
overlap, but, I think I\'m in favor of keeping them as two separate
topics.

MS. SULTON: Josephine?

DR. HUNT: I would just second that as well. I think there\'s lot of
different types of adventitious presence which we\'ve covered in the
discussion now and that needs to be separate, but, they don\'t all
overlap, I think, with the second issue, so, I think keeping it separate
will be best.

MS. SULTON: Leon?

MR. CORZINE: Maybe clarification. We did keep them separate in the
labeling and traceability and, so, I don\'t know how much you want to
expand. We\'ve got a lot of repetitive things in here already. If we
continue down that path, I guess, if we state separate statements we
should keep or \--

MS. SULTON: Duane?

MR. GRANT: Really just to follow up on Brad\'s point that this really
isn\'t clear. I agree that it\'s not clear. The problem, what\'s the
problem? In my mind, the problem is there are trade issues. I don\'t
know of any other problems that develop with asynchronous approvals
except for trade issues. And, so, I would suggest that we use that
terminology rather than just say it\'s a problem.

DR. SCHECHTMAN: If I could just reflect on what Brad said. You also
mentioned things like that having secondary effects like slowing down
product launch and development, those sorts of things as well?

DR. SHURDUT: That point. You know, if you don\'t have approvals in major
countries and clearly working and talking with the stakeholders in some
cases it does delay how you introduce a product. You know, companies are
continually sensitive about export trade and agricultural needs, so, it
could delay the introduction of new novel product.

MS. SULTON: Further comments? That takes us to the adventitious presence
statement. There is no comprehensive policy regarding adventitious
presence of biotech derived events in seed, grain, or, food and lots of
discussion. As Abby pointed out, we will obviously make sure that
whatever we write here is consistent with the other report. Leon?

MR. CORZINE: I would guess that \-- I would just comment that\'s the
most important part. We\'re consistent with what we\'ve already done
because we put a lot of time in it already and that should take care of
pretty much it, any problems, or, cover the issue, I\'d say.

MS. SULTON: Daryl?

DR. BUSS: I guess just looking ahead towards redoing this document, I
just want to raise a question. Would it be appropriate under some of
these to actually just refer the reader to the other document instead of
abstracting it again?

MS. DILLEY: I think that may be appropriate. It\'s hard to make that
judgment, I think, without actually going through that given that that
was particularly focused on traceability and labeling requirements and
industry\'s response, the food chain\'s response to that. So, I think
that may be a completely appropriate thing to do. It\'s just maybe that
there are additional points that the committee wants to add, the two to
three sentences allocated to that particular issue statement.

MS. SULTON: Michael and then Dick.

DR. DYKES: Yeah, I made that comment yesterday that I thought that might
be appropriate as well.

DR. CROWDER: I know it\'s not the time for wordsmithing, but, this has
come up twice, at least to me. The no comprehensive policy versus the
need for a comprehensive policy, just in terms of statement of issue,
came up in terms of the animals and has come up again here, the same
language. And it seems like, to me, that the topic of discussion was the
need for \-- I don\'t get hung up about it, but, it\'s a way of stating
things. I think the need for is a more positive way of looking at it,
but, I\'ll stop there.

MS. DILLEY: Actually, there is, I think, a larger question, Dick, too in
terms of just the overall structure of these statements and that they
need to be somewhat consistent, hopefully when we decide to land on our
particular format that\'s appropriate.

MS. SULTON: Greg? Sorry.

MR. JAFFE: I was just going to say that the way this one was written, I
think the way the committee, the work group had talked about this was
very much national focus. It was a comprehensive policy for the U.S.
adventitious presence policies. It wasn\'t discussing global
adventitious presence policies or adventitious presence policies in
other places. I just wanted to make \-- point that out to people that
this one was focused and especially since the traceability and labeling
report was much more focused on trade issue and the international
adventitious presence issues.

This was much more focused on the domestic needs for domestic
adventitious presence policy. That\'s not to say that we wouldn\'t
decide to include both or have a separate issue on either harmonizing
adventitious presence policies or global adventitious presence policies.
I would argue at least we\'d want \-- there has to be specific
discussion of the U.S. one.

If we were to do more, I would suggest it in a separate issue or topic.

MS. SULTON: What does the rest of the committee think? Michael?

DR. DYKES: I can see where Greg\'s coming from, so, I think if we talk
about this one, the domestic perspective, and reference back to the T&L
report for the more global aspects of a similar type of issue that seems
to make sense to me and I would think that\'s appropriate and I do agree
with Greg, this was focused domestically whereas T&L was looking more
globally.

So, if you have a brief description here and then tie them it kind of
hangs together for me, would be my point.

MS. SULTON: All right. Anything further on this topic? If not, I think I
heard Abby\'s voice coming back, so, perhaps we\'ll talk about the work
plan, Abby?

MS. DILLEY: Well, just a suggestion. I mean, I thought we have about 15
minutes before the break is maybe just talk a little bit about the other
piece of what now the committee\'s conceptualizing as a paper as opposed
to a report with chapters, but, thinking about what else, other than the
issue statements, need to be included in the concept of the paper in
terms of any kind of background, et cetera and introduction and talk a
little bit about that.

Maybe you want to go back to the proposal in terms of trimming it back
and then what\'s in that. Spend a little time on that. Take a break and
then come back and maybe go into a little bit of working groups or doing
some drafting on the issue statements. That might be helpful.

Greg, you\'re waving your card, so, it\'s just basically a process
suggestion as to how to go to the next steps.

MR. JAFFE: Yeah. I guess I\'m not comfortable yet going to the process
because, well, first of all, we have new members of the committee and
this was an old list of issues and people mentioned that it is over a
year old. There may be new issues.

There were also some issues that we said we might return to and we
haven\'t discussed whether we will and, so, for example, I\'d like \--
Dick raised an issue yesterday with the Deputy Secretary about \-- that
I think is a very important topic that I think we should include and
that was what about products from other countries that will be coming
into this country.

I mean, that\'s something the Secretary definitely needs to be alerted
to. I mean, it was something in our \-- on page 7, it was one of the
four sort of semi-discussed in one of the four there, whether transgenic
products in the U.S. moved on to the regulatory system. I\'d like to see
that as a topic, but, I think that fairness dictates that we have some
brainstorming session, or, something to let the new committee members
and people think about other topics other than these 15 or 16.

MS. DILLEY: We said we\'d do that and it obviously lasts more than just
my voice there for a minute so, yeah, you\'re absolutely correct, we
need to talk about any additional issues, not only from the current
members, but, from new members after taking a step back and looking over
the list that we have right now, the 18 issues that we have, actually,
19, I think, because we split one into two.

So, we have 19 issues, so, if there are additional issues that are
missing, including the one you referenced in terms of the issue that
Dick raised yesterday, so, we should spend a little bit of time in doing
that.

I wonder if maybe it might be best to take a 10-15 minute break, come
back and do that, and then talk a little bit about the other portions of
the paper. So, why don\'t we do that. I can see people saying, yeah,
that\'s a great idea, I\'m dashing off to get my Starbucks coffee. So,
15 minutes and start up again at 10:00.

(Discussion off the record)

(Whereupon, a brief recess was taken)

MS. DILLEY: So, when we left at the break we talked about the fact that
we need to have an opportunity to having gone through the list, to take
a step back and see if the additional topics that we want to add or
propose to include on that list. You know, it\'s been some time since we
generated this initial list, as well as we do have new members and want
them to have an opportunity to add their facts in terms of topics.

The criteria we use in terms of drafting the list were primarily two
which were that it\'s an issue of interest to one member, more members
of the committee and that we think it\'s going to be something that the
Secretary will need to be aware of, not that it necessarily has to be
under only USDA\'s purview, but, that it will be a topic that needs to
be dealt with by the Secretary.

So, I know, Greg, you had referenced Dick\'s topic that came up
yesterday. So, Dick, I don\'t know if you want to put that up there as
an additional issue and how you want to frame it, but, I thought I\'d at
least give you that opportunity if that\'s something you do want to add.

DR. CROWDER: I do want to add it. I thought Greg added it before the
break, but, we didn\'t write it down and I don\'t know how articulate I
will be.

But, the topic is biotech products developed in other countries exported
to the U.S.

MS. DILLEY: Can you elaborate on that just in terms of what you think
the issues associated with that are in a little bit more detail?

DR. CROWDER: The approval process.

MS. DILLEY: The approval process out of the country or \--

DR. CROWDER: Approval process for entering \-- the rules and the
approval process for those products entering into the U.S.

DR. LAYTON: Can I suggest a clearly defined approval process for
imported products into the United States needs to be developed to
clearly define transparent, something like that?

MS. DILLEY: Now you\'re talking about \-- there\'s two issues there.
There\'s the other country\'s approval process, but, then there\'s the
U.S. Are you talking about a policy in the U.S. to \--

DR. CROWDER: I\'m not concerned about approval processes in other
countries. If Chile wants to put

their \--

MS. DILLEY: I didn\'t think \--

DR. CROWDER: If Chile wants to approve something in Chile, that\'s fine,
and they have every right to do that. But, if Chile approves something
in Chile and says, okay, we\'re going to export it to the U.S. or Europe
is going to export it to the U.S. then we have to have a process in
place for approval in the U.S., it seems to me.

DR. SCHECHTMAN: If I can \-- Michael, did you want to go first? Go
ahead. I was going to say that I suspect that if you ask the regulatory
agencies they would say that there is a system that exists and imported
products have to follow the same rules as other products in the U.S. Let
me just finish this.

So, I don\'t know that it\'s completely accurate to say that we have to
set up a system. If there are issues \-- you know \-- if there are ways
that you think these need to addressed differently then that may be
something worth bringing up because the regulators would say that the
same rules apply. So, it\'s not that there is no process. It may be that
you think that it\'s inadequate for reasons A, B, and C.

MS. DILLEY: You want to elaborate on that, Dick, because \--

DR. CROWDER: If it\'s in place, well and good, and I\'m not going to
comment on that. The point is, is that there is going to be a lot more
coming in and the attention given to this is going to have to be a lot
more than it has been in the past, even with the \-- even if you don\'t
change the regulatory system, the process stays. The flow of the number
of products from a number of countries is going to increase and it\'s
going to require additional attention and effort on the part of the
Department, even if it is implementing what we\'ve got in place.

MS. DILLEY: Michael and then Greg.

DR. DYKES: I guess I was going to go somewhere where Michael went. I\'m
not sure that we want to say that we need the regulatory system, whether
we do or whether we don\'t. I think in my view what we\'re trying to
communicate to the Department is there is going to be an increasing
number of products coming in from other countries, does the U.S. have a
policy to handle those, manage those? Do you have a way to explain that
to the public that you\'re on top of it and we\'re ensuring the safety
of the food supply as a result of that?

Because a lot of this comes from we may have a system, but, to me, the
bigger issue is how do you know what you\'re looking for if you don\'t
know it\'s out there? So, there are a whole lot more things to me other
than the system that are a part of this. And, so, for my own mind, I\'d
just like to make some statement to the Department that it\'s an
ever-changing area, it\'s rapidly changing, are you equipped to deal
with; are you thinking about it; do you have policies in place; and are
you prepared to explain it to the public?

MS. DILLEY: Greg?

MR. JAFFE: I would agree with Michael and I think it is a broad issue,
not just a regulatory issue, but, also, that\'s right, how do you
oversee what other countries are doing; how do you know when those
products are coming into the country; what\'s your testing regime;
what\'s your oversight regime? You know, as a policy, what procedures
and things are you going to put in place, not necessarily the regulatory
approvals, but, you may have products and things like that coming in
that you don\'t know are coming in and so forth.

So, I do think it\'s a broader issue, although I do think the regulatory
pathway is not so clear. I think that you say that, well, they\'ll be
treated the same. I think that the Deputy Secretary yesterday didn\'t
say that. He said, we would treat them the way we expect other countries
to treat ours and we don\'t necessarily tell other countries, oh, go
ahead and do your own completely new risk assessment. Use ours, we say,
defer to us a lot of times.

I don\'t think, at least from a consumer perspective, I want us to be
deferring to China or Kenya or some of their products that they might
develop if it\'s coming in as a finished product. I\'m not sure I want
to just defer to their risk assessment and their food safety
assessments.

So, I am not sure he was correct in what he said, but, at least what I
understood from him yesterday was we\'ll treat theirs the same way we
expect them to treat ours. I\'m not sure from a consumer perspective I
want that necessarily if that is the policy. I\'m not sure it is.

The other thing I\'d mention is we have all kinds of laws and
regulations and things set up especially for imports that are
independent of biotech. They may be duplicative. There may be gaps that
are filled in because of those kinds of things and, so, there may also
be a need to clarify some policy about what do you do because you would
have \-- there are specific things that are done for imported products
and things like that.

The final thing I might mention is a lot of these will come in again as
sort of finished food products. It might be something that\'s grown in
China or Chile or things like that and it doesn\'t come across as an
organism, but, comes across as a product of an organism and what is the
policy at all going to be related to those from FDA and USDA and so
forth?

So, I think there\'s a broad policy thing.

MS. FOREMAN: How much of this would be covered by the equivalence
agreements that we have, generally speaking, if the other countries have
systems equivalent to ours? We admit the product, when you\'re talking
about imported food more generally. And since ours for regulating
biotechnology is fairly limited on the plant side, what do you think the
role of equivalence is there? And Michael may know too.

MR. JAFFE: I mean, I\'m not really sure. I think maybe more on the food
side than the plant side. I mean, one of the things that at least APHIS
has talked about, BRS in their proposed EIS in change in regulations is
they\'ve talked about taking authority over not just parts of plants or
parts of plant products and things like that.

It\'s unclear what \-- not just the organisms but maybe parts of plants,
even if they\'re not reproducible which might address some of these
import issues. I don\'t know what they\'re going to do on some of those
areas.

So, and it\'s unclear whether then they would take \-- the EU countries,
which we\'re equivalent, whether they would take those and defer to
those on a high profile issue like that, I don\'t know.

MS. DILLEY: Michael, do you want to add and then your own?

DR. DYKES: I don\'t have a lot to add other than I\'m where Greg is. I
don\'t think they really know. I think they\'ve had a lot of discussions
about it up to this point, but, I don\'t think they\'re really clear and
I think a lot of it depends on what they do on these changes to Part 340
by tiering the different risks.

I\'d say in summary, if a protein were to be identified today of which
they have not done a risk assessment I think the answer today, as of
this morning, would have to be it\'s not allowed here. Jim could answer
that if he was here, but, that\'s my understanding of the current
situation if it\'s one for which they\'ve done no risk assessment.

MS. FOREMAN: What about food product? That comes under FDA.

DR. DYKES: Other than a biotech thing, Carol?

MS. FOREMAN: A biotech.

DR. DYKES: Well, again, I think if it was \-- I think based on what
they\'ve done before, if they found a protein they would say, if
they\'ve not done a risk assessment it\'s not allowed here and, Ron, and
Kraft, and General Mills, others may.

I think \-- which I think that is what\'s tied up in finalizing the
draft AP guidance that FDA put out and I think some of it was also tied
up in the changes to the USDA regs in terms of clearing the risk which,
I would add, I would agree with Greg, it\'s not finalized either.

MS. FOREMAN: I thought we had FDA guidance \--

DR. SCHECHTMAN: Microphone, please. Microphone.

MS. DILLEY: Carol, you want to wrap up and then let\'s go to Daryl and
then Brad.

DR. BASS: Similarly, I think we\'ve adequately answered the spirit of
the intent.

DR. SHURDUT: Similarly, I think we went around last here, but, I just
wanted to make sure and I think Michael touched upon it, that this is
not just products, but, also it covers the adventitious presence about
incoming products because if we focused on our AP domestically and I
don\'t know if in that definition we included the imports as well. But,
it\'s the U.S. AP policy for imports.

MS. DILLEY: It seems like there\'s a broad spectrum of issues that are
generally raised in terms of increasing number of products being
developed elsewhere. Okay. Mike?

DR. DYKES: Just one other quick comment that wound up at the upcoming
CODEX meeting in September. The biotech task force, this is one of the
areas that they\'re looking at, Carol, is, do we establish an
international body of CODEX, for example, as what\'s been done on
pesticides and other things so that if you have not done a risk
assessment maybe CODEX has looked at it and there\'s some level of risk
assessment\'s been done you can choose to use it if you want to for
countries, but, I think, even in the U.S., in the case of the U.S., I
don\'t think we\'ve deferred to the CODEX decisions historically
speaking.

To Greg\'s point, we want to do our own.

MS. DILLEY: Anything else on this particular set of issues on this
topic? Are there any additional other topics that people want to raise?

DR. HUNT: Well, I brought this up yesterday when we were talking about a
topic on trace insurance programs and that was the need for global
harmonization of methodologies and also for something that would ease
essentially some of the issues that we\'ve been discussing and the new
one we talked about was the mentioned testing. We need to know what
we\'re testing for; we need to know how we\'re testing; we need to know
how to sample it and when to sample it and so on.

And, to me, they haven\'t gone really strongly through in their issues
as they\'ve been written to date.

DR. SCHECHTMAN: Can I suggest that we \-- that for that one it might
make sense to look \-- since that was discussed in fairly great detail
in the other paper that you look for a piece of language that captures
that from the other paper so that it can be in there, in this list.

DR. HUNT: I think that makes a lot of sense if that\'s already
published. But, I would like to see it within this document just for
completion sake.

DR. DYKES: I think another general area that with this previous
conversation and with many of the things that were raised and being
defrayed and the belated nature of these issues, or, what happens to
U.S. products that are exported, I think that we need to have some
mention to the Secretary of the staffing needs and not necessarily
numbers, but, the expertise and do we have the technical experts in our
embassies and through other SPS measures or whatever else SPS committees
or whatever else that we have the people out there that are
knowledgeable of U.S. process system, knowledgeable of this area of
technology and they can serve as a resource.

It\'s going to be growing because other countries are grappling with the
same kinds of things we are. I think that whole area for the secretary
to be thinking about. What\'s the Department of Agriculture doing to
advance U.S. agricultural production to Chuck\'s comments yesterday.
We\'re producing food. We have to have trade.

If we\'re going to have to have trade we\'re going to have to think
about all the other things that we need to ensure and facilitate trade
relative to the biotech issues, which, I think, as we lower the subsidy
issues if that happens, the more that will do, the more of these
technical barriers we\'re going to see.

MS. DILLEY: You\'re particularly talking about sufficiency in terms of
numbers and expertise of staff at USDA on trade issues specific to
biotech, or, is that broader than that, or, is that the particular
focus?

DR. DYKES: I would limit it to the biotech aspect for agriculture
production and it\'s not just the numbers, but, it\'s do we have the
technical expertise? Are we anticipating the regions of the world where
we\'re going to need them? Do we have them there? Are our people trained
and equipped?

Because I think it takes them \-- moves them from more a market
promotion type of thing to much more in-depth knowledge of at least
being able to respond. So, what is the situation with this trade in the
U.S., for example. One aspect of it. It\'s a whole huge area that I\'m
not sure \-- and I think that also goes, and it may be a separate deal,
but, it\'s a summary thing.

I think we need to be anticipating the next five to ten years in terms
of APHIS and do we have the technical expertise that\'s going to be able
to evaluate some of the new advances that are going to come? Because
they\'re not going to be the single gene inserts that we have typically
seen. They\'re going to be RNA inhibitors. They\'re going to be
transcription factors. There are going to be other things coming.

And, so, in anticipation of that from the Secretary\'s perspective of
30,000 feet are we ready to address those things?

MS. DILLEY: Dick and then Lisa and Leon.

DR. CROWDER: I want to echo Michael\'s comments on staffing domestically
and internationally. But, question, Josephine, and not being a testing
expert and I don\'t recall exactly how we dealt with it in the tracing
and labeling paper, do we need harmonization or do we need equivalency
in terms of testing?

I\'m not being an expert on this. I don\'t know. But, if you say
everybody in every part of the world does the same test at the same time
with the same material, I don\'t know.

DR. HUNT: I think with the kind of techniques which you employ it\'s
very important that there is harmonization because of the different
types of techniques. The people need to be using the same kind of
method. And I can\'t remember the details of the T&L document, even
though I have read it, but, I\'m sure it\'s addressed in there.

We can cross check.

MS. DILLEY: That\'s like standardization and harmonization, right? Lisa
and then Leon.

MS. ZANNONI: This is actually to add to Michael\'s point with the
staffing, U.S. staffing in countries with expertise. Along with that the
capacity building for countries because what these countries are doing,
you see them under the Biosafety Protocol and Greg was talking about
this at the break. They\'re putting things on paper so they have
regulations, but, they don\'t have the know-how to get to a decision.

And there\'s very few countries that can get \-- deal with capacity
building and because you already have to know how to do it, have the
systems in place, have already made decisions to teach another country
that people in that country could do the same thing.

So, I think the U.S. has to be a leader in getting industrialized
countries that can do that to countries that need that, but, you will
always have issues with approvals if countries can\'t make decisions.

MS. DILLEY: Leon and then Bob.

MR. CORZINE: Lisa pretty well summed it up. I would say though that
we\'ve got \-- there are two topics. One is the international arena and
FAS and that area where we need the resources and expertise and also
domestic. For domestic approvals the expertise, kind of what Michael
referred to as well. So, we really have two topics and they\'re both,
I\'m not sure USDA\'s prepared for at this moment.

So I think we should list them as two.

MS. DILLEY: So, it\'s overall kind of the issue of increasing number of
products and we need to address the staffing levels and expertise both
at the domestic and international level. Bob?

DR. HERDT: Yeah. I\'m not sure how much the committee wants to get down
the road that I\'m going to suggest, but, it\'s a little bit of a
different direction, although building on the last couple of comments.

So, let me just take a minute. Maybe the issue could be stated like
this. The capacity of the poorest developing countries to deal with the
scientific, intellectual property, regulatory, and international
negotiations requirements related to biotech food will limit the growth
of U.S. exports in the future.

And given the dramatic emphasis he placed, Conner placed on exports, and
we know the reliance of U.S. agriculture on exports, there\'s a chain
here. I really believe that what we\'re facing in a number of countries,
especially in Africa, is a lack of trust because there are very few
people from those countries who have the technical capacity, the
scientific capacity, you know, the legal, the negotiating capacity. I
mean, we\'ve got battalions of people who go to these meetings, or, at
least companies, if not battalions. Battalions, all right, battalions.

And, you know, Zambia has two guys. And you see the same two guys every
\-- you know \-- now, I mean, they don\'t have any scientists able to
say, yes, you know, what these guys are saying is actually, in my
personal understanding, true. So, you know, there\'s a big pipeline to
be filled and what we are doing, when I say we, USDA and USAID, are
limping along with completely inadequate financial support to efforts to
help build capacity.

You know, and I\'m not sure if this committee wants to go there, but,
you know, I could expand on this for weeks if you want. I know you
don\'t. But, it\'s really, in my view, it\'s this basic capacity. I
mean, you know, they need to have people with Ph.D. degrees in molecular
biology who have the capacity to really know the science and to say to
the President of Zambia or Uganda or whoever it is this week, you know,
yes, yes, sir, this is okay.

And just because those guys from Monsanto say so or USDA doesn\'t mean
it\'s not okay, you know, and that\'s what we\'re facing. But, we don\'t
have the resources. We have not deployed the resources in this country
to address the capacity building. We did deploy resources to address
capacity building in India in the 1950\'s and 60\'s and 70\'s and
that\'s why India is out there in front.

I mean, yeah, they\'re having a big argument in India about biotech,
but, they\'re having an argument. They\'re not saying, you know, well,
we don\'t trust these guys. I mean, but, it\'s their argument. And they
will put in place regulations and then we\'ll see, well, Greg, are they
okay for us, you know, but, they\'ll have something.

And our scientists can talk to their scientists and, you know, we\'ll
have it, but, right now we\'re just trying to \-- Cornell is the prime
recipient of the Agricultural Biotechnology Support Project which is
USAID\'s primary instrument for trying to get acceptance of ag
biotechnology in the countries that are reluctant to do it, the poor
developing countries.

You know, it\'s three or four million dollars a year, most of which
goes, you know, for U.S. scientists to do their thing. Very little goes
for actual training at depth. So, enough said. That\'s my issue. One of
my issues that I\'ll put out to you.

DR. SCHECHTMAN: Do you want to just restate the sentence of the issue
you just did?

DR. HERDT: Yes.

DR. SCHECHTMAN: Say it again.

DR. HERDT: I thought that I was using the mike but I can restate it.

DR. SCHECHTMAN: No, no.

DR. HERDT: Yeah, for the information of the committee.

DR. SCHECHTMAN: Yes.

DR. HERDT: The capacity of the poorest developing countries \-- I\'m
stressing the poorest, I\'m not talking about India and China where
economic development is accelerating. I mean, I don\'t think it\'s
accelerating in China anymore but certainly accelerated. And they have a
lot of capacity.

I\'ll tell you about the poorest developing countries to deal with the
scientific, intellectual property, regulatory, and international
negotiations requirements related to biotech will limit growth of U.S.
food exports, agricultural exports. And then, you know, if we want to
\--

MS. DILLEY: I saw a lot of heads nodding when you were talking so I
wanted to see if anybody else had any additional comments or questions.
I\'m sure you captured it. Dick?

DR. CROWDER: I\'d just like to echo his comments on the need for
capacity building. It is a big issue. There is just no two ways about
that.

MS. DILLEY: Okay. Michael? A new topic or on this one?

DR. DYKES: A new topic. I\'m not really sure exactly how to articulate
this and perhaps others can chime in. But, I think another thing to
anticipate is the shifts that are likely to occur in agriculture as a
result of biotechnology and the spending on research and development.
And I\'m thinking primarily about something as an example what will be
the U.S. role in wheat production ten years from now if we stay on the
continued path we\'re on with using 30 year old varieties to produce
wheat and no incentive for R&D in wheat. What does that do?

The land is used to produce something less and it doesn\'t go to
highways and so forth, but, there will be shifts and what does that do?
The technology is going to bring shifts as it makes \-- as we bring more
technology to some crops than we do other crops, make those more or less
economically attractive, we\'re going to create shifts.

And, somehow another \-- I think there has to be someone, especially at
the Department of Agriculture, that\'s trying to look at this and
anticipate this five to ten years out what do they do about it and what
do they want to do about it and how do we manage it and how do we manage
the impacts of it? Because the technology\'s going to change the way
different \-- the cropping systems and the acres and the production of
various commodities.

MS. DILLEY: I\'m trying to envision the sentence that captures that
because it seems like in one you focus on the research, but, it\'s
broader than just research. It\'s looking at the whole expansive
landscape in terms of how ag biotech is evolving and what are the
implications it has for agriculture generally and, to me, it\'s almost
like the sum total of these issues, but, I don\'t know the sentence or
couple of sentences to capture what you\'re saying, Michael, and I\'m
not sure I\'m capturing it adequately.

DR. DYKES: Yeah, I don\'t know that I am either. I think it\'s kind of
the impacts of technology and what \-- and both domestically and
internationally you could think about, too, Bob\'s point about India and
what they\'re doing in advancing and adopting technology and that\'s
also going to be shifting acreages as well and shifting efficiencies.

And what\'s the impact here domestically for the Secretary of
Agriculture to be anticipating?

MR. CORZINE: Maybe you stated it. The impact of blocking technology
development, where you expand that into specific crops because we have
already seen shifts. In my part of the world you don\'t grow wheat
anymore. You\'re growing less and less soybeans because that was
somewhat blocked technology development there as well, so, I don\'t know
if that helps capture it.

But, the impact of that out five to ten years, we\'ve already seen it in
the past five years.

DR. HERDT: I wanted to follow up on the research issue. It seems to me
that biotechnology has given a big push to research on certain crops and
it\'s drawn the best and the brightest from academia into those crops,
into those fields. Essentially, they\'re the crops where companies \--
the seeds of those crops can make a lot of money.

So, you know, going big time in those things. On the other hand, for
crops where the market is small, research money is dwindling and the
interest of scientists, therefore, is dwindling. Let\'s face it. We\'re
like everybody else, we follow the money. So, and, in fact, you all have
seen the report on plant breeding, the training of plant breeders in the
land grant colleges is going down because they\'re doing microbiology.

I think there\'s one \-- but, anyway, I think that\'s the issue,
Michael, isn\'t it?

DR. DYKES: Absolutely.

DR. HERDT: But, that\'s one of the issues.

DR. DYKES: Absolutely, big part.

MS. DILLEY: Daryl?

DR. BUSS: Well, just to take a run at it. I was thinking about this sort
of a statement just for reaction. The Department should consider the
impact of the lack of application of biotechnology to certain plant
species, such as wheat, to the future of U.S. agricultural production
and producers.

DR. DYKES: I don\'t know if I\'d want to necessarily want to single out
wheat. I only used it and I only used it as one, but, I think there are
many examples. But, yeah, I think that\'s in the defining things of
where I was coming from, but, I think it also includes some of the
aspects of what Bob\'s talking about, about plant breeders who going out
with germplasm and put genes in.

DR. HERDT: That may be what the Department\'s pointed out in one of the
new work talking about minor crops in part. Wheat is not a minor crop,
but, I mean, it\'s that whole issue of other stuff. So, maybe, you know,
one statement in here that tries to capture that.

MS. DILLEY: Carol and then Duane.

MS. FOREMAN: I think you\'re right. I think that the minor crops
question that they\'re giving probably goes to that and I think that
something that talks about the need for research money in crops to help
improve crops that aren\'t likely to be big moneymakers is a worthwhile
public purpose.

I think that nobody has done anything to block biotech wheat. It has
failed to gain acceptance. And I\'d be very uncomfortable with anything
that suggests that biotech wheat is not out there because of some public
conspiracy. It\'s not out there because it has failed to gain acceptance
within the public and, as people who sell food know, it\'s real hard to
get people to buy something that they don\'t want to buy and farmers and
food processors will always be dependent on being able to sell the
product to a retail consumer who wants to buy it if it\'s a visible
product.

We talked yesterday about why the feed grain weren\'t that visible. So,
I\'d be reluctant to have a statement that suggests anything other than
some of these crops have failed to gain acceptance.

MS. DILLEY: Duane?

MR. GRANT: I like Daryl\'s statement and I actually don\'t mind singling
out wheat. I wouldn\'t oppose that. And I think this is an issue that
USDA will need to address. I think we\'re already seeing and I could
actually demonstrate that we\'re already seeing significant shifts in
planting patterns within the U.S. driven by access to biotechnology or
the lack thereof.

And I think we\'ll continue to see that evolve, not just within the
U.S., but, will also see it evolve globally and it is definitely
something USDA needs to be aware of and be studying and be preparing
U.S. agriculture to make the right choices in.

So, I guess I want to take it one step farther. It\'s not just
opportunity for commodities that have access to biotechnology, I think
we have to prepare ourselves for emerging trading blocs, some which
accept biotechnology and some which do not and the changes that that
will drive in production of agriculture especially within the U.S.

MS. DILLEY: Okay. Pat and Dick.

DR. LAYTON: I think mine may be more a recommendation and not an issue
so I\'m going to withdraw it, but, in thinking about some of the
discussion, the capacity building, the minor crops issues, the
discussion we had yesterday about crops for other countries that are the
poorest nations, how do we get some of those worked on, and not just
genetic engineering, but, to some extent the genomics piece and the
breeding piece of those, and capacity building in terms of the
technology in those poorest countries.

It would be interesting to consider a joint AID/USDA effort pairing
those partners or those countries with some of our currently supported
land grants who are involved or could handle it to do \-- to bring the
masters and the Ph.D. students to the U.S. to do that training and to
work on some of those crops and our minor crops that might grow there
also, to think about that.

But, that may be too much of a recommendation and not an issue and I may
withdraw it and it may be in the next report, so, I wanted to throw that
out.

MS. DILLEY: I think both of those are true. They\'re important issues
and the committee may want to spend more time on those and if it\'s
beyond kind of the scope of what we\'re currently doing in terms of
framing topics.

Dick and then Michael.

DR. CROWDER: I think we\'ve got a couple of issues. The first one, I
think, going back to Michael\'s, in terms of the impact on production
patterns and so forth, I would suggest that the issue may be something
like, or, the topic may be something like following the impact of
availability and adoption of biotechnology domestically and global on
crop production patterns in the U.S.

I think that\'s because we talk in the U.S. about the issue of minor
crops. There\'s not a vegetable in China that\'s a minor crop. And they
are working on it. And as they adopt those it\'s going to affect our
competitive position. They are much further ahead than we are on rice
and so are the Philippines and so is India and you start getting into a
lot.

So, it\'s the availability and adoption and, Carol, it gets away from
what causes it or doesn\'t cause it, but, the availability and adoption
rates are going to affect what we do and the Secretary ought to be
looking at domestically and internationally.

Then there\'s the whole other of research and so forth in terms of
policy implications, I think, that come out of that.

DR. DYKES: Yeah, I like what Dick\'s saying and I agree with where
Carol\'s coming from because I don\'t think it matters whether they
block it or whether they adopt it openly, that\'s not in my mind. It\'s
the change and that\'s what needs to be anticipated. So, I agree, it
should be more as Dick has stated it.

I think to your point, Pat, in my mind, if we highlight this and this is
something the Department looks at, and I agree, I don\'t think it\'s a
recommendation, we probably shouldn\'t put it here, but, in my mind,
where I\'m thinking about this issue, that\'s one of the things that
could very well could lead to an integration with AID as to what we are
trying to accomplish globally and I also agree with you that it goes to
the genomics and the marker breeding and all those kinds of things that
are a part of biotech, but, not a transgenic event necessarily.

Minor crops, I think, is, as Dick points out, which is what I was going
to raise, minor crops is a relevant term, apparently subjective term. It
depends on whose point of view you\'re looking at. And I would argue
that, again, we have some crops in the U.S. today that ten years from
now we might call minor crops in America. Oats would be one that I would
say has gone, when we think back two years ago, oats, and today I\'d say
oats is a minor crop in the U.S.

MS. DILLEY: Is that a better term?

DR. DYKES: Well no, I\'m just saying that we\'ve got to be thinking
about minor crops and that\'s a changing definition. It changes, depends
on whose perspective. And that\'s not a good thing or a bad thing that
oats, from what they used to be 30 years ago to today and now a minor
crop, it\'s just a change that\'s occurred and one needs to, when
you\'re talking about ag costs, you just need to be aware of it and try
to anticipate those things happening.

MS. DILLEY: Jerry?

MR. SLOCUM: I don\'t think oats are a minor crop yet, Michael. There\'s
still five to six million acres of them. They\'re just not horsepower
anymore. We don\'t have to feed the mules oats to pull the plows. It
seems like to me there are three issues that Duane mentioned; an issue
about emerging trading blocs and that\'s not part of this issue about
availability and adoption of biotechnology and it\'s not a part of this,
what I keep hearing about training U.S. researchers, which is a U.S.
technical capacity to keep up with genetic events and competition around
the world, right?

USDA does a lot of thinking about crop mixes. I mean, they publish every
February ten year baselines for every major crop in this country, the
soybeans, and corn, and wheat, and even oats and barley and all sorts of
things. It\'s a huge effort that they do and they release it late
February here in D.C. every year and it\'s widely anticipated and
guessed at.

But, people in the industry use it as a tool and not only people in the
U.S. industry, but, people in the world industry. And believe it or not,
they make some assumptions about adoption of biotechnology and about new
developments in biotechnology and about things like how well or how
poorly we manage Asian rust and U.S. soybeans and so there\'s a lot of
thought at the Department given to those things.

Now, so, if you wanted to think about that from a different perspective
you\'re going to have to word the issue so that you don\'t just look at
it and say, yeah, we\'re doing that. You\'re going to have to word it in
a way that says to them you\'re missing something, keep filings in your
assessment because he\'ll say I\'m already doing that, Jerry, and, to a
large extent, he\'s right.

I do think there\'s \-- and when we talk about the emerging trading
blocs we\'re not going to talk about that right now because is that an
issue? Duane put that on the table late in the discussion, but, in my
mind, that\'s another issue rather than the two that we sort of
confused, okay.

MS. DILLEY: I think that\'s probably a separate issue and it may be part
of the issue that we talked about earlier, the trading blocs and other
moratoria or other things. I don\'t know if that falls into that, but,
maybe it\'s a separate one.

DR. SCHECHTMAN: You mean blocs, without a k?

MR. SLOCUM: Exactly, blocs, without a k.

MS. DILLEY: Pat, did you have your card up?

DR. LAYTON: Yes. Yes, I did. I think the issue, it goes to research
again. I\'m going to bring that research issue back up. The
administration has pushed to take formula funding away and make it more
competitive. There was a move to reduce by half, Hatch and McIntyre sent
us this year, and to zero it out next year.

That is formula funding. Formula funding to land grant universities has
allowed research to take place in a variety of areas that were not
creating new science but were solving applied problems. Given that, when
we reduce that we do not have the capacity to solve applied problems
and, therefore, when we as researchers go out to put in proposals we
don\'t find \-- we can\'t go do me too for genomics of lima beans
because we\'ve already begun the genomics of rice.

So, there\'s no new science to be created by doing that. So, I\'m going
to go back at \-- there is a need to rethink formula funding versus
competitive funding or some way to look at competitive funding so that
we allow that stretch of research over the variety of USDA type products
or the ag products to occur.

Does that make \-- do you all understand what I\'m talking about?

DR. SCHECHTMAN: I just note, I think you raised a really interesting
issue. The question that I have is I note that we have a very, very
vague place holder \--

DR. LAYTON: For research.

DR. SCHECHTMAN: \-- for research and it\'s got multiple issues that we
haven\'t talked about. Now, you sort of want to raise that question to
the committee of what people feel is the best way to deal with those. I
mean, it\'s obviously a very interesting issue. How do people feel about
it?

MS. DILLEY: I\'m trying to \-- do we need a particular topic on
research? Anyway, Ron and then \--

MR. OLSON: I might be a little bit late here. We don\'t consider oats a
minor crop, but, obviously, the U.S. has basically de facto abandoned
oats. So, most of you probably know that the oats that goes into our
food supply doesn\'t come from the United States. All of oats pretty
much comes from Canada. So, most of the private funding, whether we do
it or Quaker or you can name the two big horses, if we do any funding of
research it\'s all in Canada today.

And malt barley is going through the same issue and we\'ve alluded to
wheat from Duane, and Michael, and a few others. Wheat is on a path,
given the current structure of the farm programs, to do the same thing,
and especially with diseases and things like that.

The thing I guess I\'m throwing out is, I think USDA is aware of those
shifts and they\'re allowing them to happen, but, the thing that I
don\'t think they\'re fully aware of is the substitutability issues that
arise. So, you could start \-- and this gets into policy issues. If you
start taking wheat to a minor crop, or, oats to a minor crop, whatever
it is, you increase the amount of contracting that goes on and it
removes price discovery from the marketplace.

And most of the farm programs are based on, I would call, the concept of
a family farm where all farmers get the same base loan rates and stuff
like this, but, you\'re going to get a lot of dichotomy in prices where
you have two farmers growing wheat and one guy\'s going to get a dollar
a bushel more than his neighbor because it\'s in the contract of
non-transparent system as the crop gets more and more minor or more and
more targeted.

We saw it this year on high protein wheat. People say, you know, wheat
prices were cheap. I mean, if you had high protein wheat it was trading
at \$6.00 a bushel this year. So, the market \-- I guess what I\'m
trying to say is the market has \-- I\'m the economist here, I guess \--
but, the market will help dictate how farm policy is written and you\'re
going to get into substitutability because to get into soybeans it is
not out of bounds to say that we don\'t need wheat anymore ten years
from now.

I don\'t know if ten years is the right number, but, if you solve a
couple of issues in soybeans genetically you basically can make the bulk
of the wheat product out of soybeans and I don\'t know if that has any
implications for farm policy or things like that, but, the USDA needs to
be conscious of the genetic advancements that are made in other crops
that could substitute for what we would call today, major crops, and,
again, wheat becomes the primary issue.

If we can\'t get biotech wheat accepted or advances made on wheat,
whether \-- maybe the market just solves it. Maybe we\'ll just pay
\$10.00 a bushel for wheat some day to get farmers to grow it and
that\'s the only issue that\'ll happen.

But, they need to be aware of the market dynamics as well as just the
science behind it. I don\'t know if I stated that very clearly or not.

DR. SCHECHTMAN: Can I ask you a question on that? Does that mean since a
lot of the issues around wheat had to do with the product being one of
those more directly visible products, if soybean takes up those issues,
takes up some of those roles, wouldn\'t you expect that those new
soybean varieties would take the issues with them?

MR. OLSON: I\'ll speak to that briefly. I think the issue on biotech
wheat was not so much the U.S. consumer because it never got that far.
It was on market access thing worldwide of exporting it to other
countries because we export half the wheat crop. So, when you get, you
know, your top, I think what was eight out of the top ten countries said
I\'ll never buy a bushel of wheat. If you grow one bushel of it I\'ll
buy no wheat from the United States in any class so it became a market
access issue worldwide on the export side which really \-- which put the
brakes on a significantly faster than a consumer reaction because the
consumers didn\'t see it.

It wasn\'t in the marketplace yet or anything like that, so, I think
it\'s an issue that we\'re conscious of, but, wheat is a food crop for
people and soybeans and corn are not, even though they eat all the
derivatives of those grains. So, there\'s a different attitude out
there.

You bring up a good point, Michael. I don\'t know what the reaction
would be if you started making all of our bread out of soybeans today.

MS. DILLEY: I\'m not sure how to exactly capture all that you said, Ron,
on the comments before this, but, it just seems like there\'s a much
more complex and richer story about the impact of availability and
adoption of ag biotech on production patents.

I mean, you really elaborated on that whole series of issues.

MR. OLSON: Yeah, and I think from the USDA\'s standpoint what it starts
to affect is how we write farm policy. We write farm policy today on
where all farmers are treated equally in a sense. You get the same
amount per bushel and stuff like this. But, if you have \-- you\'re
going to start to segregate the market more and I think the USDA needs
to be conscious of that, that some of these crop shifts occur.

And that gets into the \-- it gets complex because what\'s the
substitutability of other things in the market to make the same product.
And most companies look at that quite strongly. I mean, if the price of
oats goes to \$4.00 a bushel you certainly seek to be making out of
barley or can you make it out of something else and that\'s what the
market\'s job is, is to do that.

But, the USDA needs to be aware of that.

DR. CROWDER: I think some of that \--

MS. DILLEY: Duane, you want to talk to this specifically? And then I had
Michael and Daryl.

MR. GRANT: Yeah, I did want to try to follow up a little bit, I guess,
how we see it happening from the ag perspective, what Ron\'s been
talking about. Farm policy does drive \-- what we\'re observing is that
we\'re able to go biotech on beans and corn. Of the export commodities
we can go beans and corn. Anything else that moves outside the U.S. we
haven\'t been able to find \-- that\'s a food product

\-- we haven\'t been able to find a way to move to biotech on.

Now, we may be able to make a few inroads, but, that general rule holds
and that\'s what\'s stopped wheat. It wasn\'t the domestic market, it
was the export market. I don\'t \-- I don\'t really see that changing.
And if that continues that will definitely drive changes in U.S.
cropping patterns in a way that\'s at least as powerful as farm policy,
farm programs do.

I don\'t know if that helped to illustrate that at all, Ron. That\'s
really how we see it playing out. And that\'s a big issue for us.

MS. DILLEY: By the way, I think that\'s been explained in terms of
impact on cropping pattern. Michael, I don\'t moved past your point and
then Daryl and then Dick.

DR. DYKES: Well, I agree with the conversation. I was going to come back
to the trading blocs. I think trading blocs are a part of this as well
and I would use the example of Brazil. Look at what happened in the
Chinese requirements for safety certificates. That\'s what worked Brazil
out of the pocket to have to acknowledge that 90 percent of their
soybeans are biotech soybeans.

And if we look at going into Doha, Brazil is no longer there. They\'re
there with a different type of mentality because they do have to worry
about protecting their own exports of Brazilian soybeans and Brazilian
cotton from the same types of issues.

Argentina is in much the same situation and it relates to corn and beans
as well. So, I do think there\'s a part of this technology and adoption
and production shifts that influence the trading blocs and I think from
a USDA policy perspective we need to be anticipating more of those are
going to occur because they\'re non-traditional allies and some of those
kinds of things, the examples I just gave.

DR. BUSS: Well, for my time was actually going to be back on the
research findings so if Dick, you know, has a comment on this I think
that would be \--

MS. DILLEY: We\'ll talk to Dick and then come back to you.

DR. CROWDER: I just \-- on the point that Ron and Duane were talking
about I think there\'s some language, if I recall correctly, in the
tracing and labeling report on this that we might want to go back and
pull out for this that we don\'t have to recreate.

MS. DILLEY: Daryl, back to research.

DR. BUSS: Yeah. I think that it is important for us to fold in whether
in these issues or as a separate one the importance of continuing
research funding, both for the research and for training. I would feel
uncomfortable about specifying or endorsing a particular mechanism of
funding so I would be concerned about specifying that need to be formula
for funding because there are other ways to do that.

So, I think we need focus on the need for research and research funding
and then let it go at that.

MS. DILLEY: Okay. Michael?

DR. DYKES: To further comment on the research, and I\'m more where Daryl
is. I understand what you\'re saying, but, I think the general trend has
been NIH type of atmosphere in agriculture. How that comes about is to
be debated, but, I think I agree that we need to lodge with the
Secretary to recognize that there\'s going to be changes, whichever way
they are, good or bad, but, there are going to be changes in the way
agriculture research is funded.

And the Department needs to be anticipating, especially from an ARS
perspective and from many of these other points, how that is going to
impact ag policy at the Department.

MS. DILLEY: Are there any other topics that we haven\'t touched on?

MR. CORZINE: I might have one. And I think it is a topic. We\'ve covered
a really broad spectrum, but, I think maybe we need to point out to the
Secretary that more could be done to help biotechnology in general on
the environmental benefits of biotech products as far as in sub-sets
under that would be, you know, we could talk about chemical use, but,
maybe even before that, soil losses. There\'s a soil loss equation that
was very important back in the mid 90\'s that we achieved much quicker.

One goal that was hit very early that doesn\'t happen very often and I
think that \-- I think the Department could do. That\'s a topic that
should be pointed out. In essence, we have a lot of other topics that,
you know, here is something that there hasn\'t been enough publicized to
work on.

MS. DILLEY: I\'m trying to wrestle with the exact statement of it. Are
you looking \-- is this an issue on research, more research needs to be
done?

MR. CORZINE: No. It is more communications. We\'re talking about
communications really.

DR. SCHECHTMAN: If I could just \-- I want to be a little careful. One
of the things we haven\'t \-- we\'ve tried not to do in the issues is to
not get into recommendations on the issues. So, if there\'s a way that
it can be stated as a topic discussed that might ensure us a greater
consistency with a lot of the rest of the report.

MS. DILLEY: Other cards are up, so, I think it was Carole, Dick, Alison.

DR. CRAMER: so, my comment was pretty similar. I\'ve done this over and
over in this committee, but, my biggest concern is that there\'s
tremendous benefit that could be brought about that are not coming
through due to market forces and public perception and a lot of \-- I
mean, there needs to be more effective communication and that\'s
something that we see from the educational points of view and it\'s not
just biotech, but, an understanding of where our food comes from, what
the process is, where health issues are.

And, so, I had the same sort of problem in trying to articulate that,
but, I think that some sort of statement that effective communication of
the benefits to the environment and to public health that are emerging
from agricultural biotechnology and need to be effectively communicated
in order for us to be gaining those benefits and, help out, guys,
something from that point of view.

I mean, that\'s my nightmare when I go out of here is the opportunities
that are being lost to make a real difference globally.

DR. CROWDER: Leon made a point that reminded me of a point and it is a
process question. One of the sections of the earlier drafts listed
benefits as topics were discussed. Where did that get into paper now? In
the second part of the paper?

DR. SCHECHTMAN: Our suggestion, in fact, on this was that that section
would not \-- our initial suggestion was that that was not going to be
included.

DR. CROWDER: I have some real problems with that.

MS. DILLEY: I think the question is to the committee of where to include
that. I think it\'s also the question that I\'m trying to shape it as
either a topic in this section and keeping it within the context of
future products and, so, I\'m not sure, Dick. I mean, what \-- do you
have a sense of how to frame it in a topic format like we\'ve been doing
to capture that?

DR. CROWDER: Sure. We discussed \-- I guess in terms of concept, in
terms of how to do it, we spent quite a bit of time talking about these
and items were drafted and everything else and they were topics of
discussion such as the same as the topics of discussion we\'ve got going
here.

And I don\'t understand the merits or the logic of sending a report
forward that says these are policy topics that we discussed that you
ought to consider and leave this out and give the Secretary and the
public the impression that we talked about this for two years and never
discussed any benefits and I guess I\'m going to have some difficulties
getting past that bump in the road.

DR. SCHECHTMAN: If I can respond to that a little. I think the
discussion was the idea that we had was that that wouldn\'t be a section
of whatever introduction there was to this, but, I think \-- I mean, I
think you\'re quite right that it was a topic. I think you\'re quite
right, it was a topic discussed and to the extent given that the text
was quite \-- there was quite a bit of disagreement about what to
include in there it may make sense to have it included though as a topic
discussed again in the same format as others.

DR. CROWDER: I\'m with you in that concept because I understand there
were some differences of opinion on that just like there were and still
are differences of opinion on the topics that we have, but, I think that
that set of discussions should receive equal treatment to the set of
discussions we\'ve gone through in the past 24 hours.

MS. DILLEY: I think, again, and just like we\'re opening up to other
topics, if there\'s a way to formulate the language to raise those as
topics then let\'s do it. So, if you want to think about that in terms
of particular language and come back to you? Whatever you want to do.

DR. CROWDER: I will and I think it ought to be shortened, abbreviated,
similar to this. It ought to be treated in parallel to what we have been
doing with the rest of it.

MS. DILLEY: Alison, Carol, and then Daryl.

DR. VAN EENENNAAM: I guess it gets down to some of the benefits that are
documented in here and it seems to me the USDA has by now ten years of
data with regard to the use of biotech crops in U.S. production. What
has been the environmental impacts with regard to pesticide use and that
type of thing because you kind of have those two contradictory reports
that interpret USDA data, Gianessi and Benbrook that basically come to
opposite conclusions somewhat.

And I know it\'s how you interpret them, blah, blah, blah. But, what I
would really like to see is some, you know, neutral USDA scientists put
out some peer review data on all that data that they have to give us
some idea as to what actually the benefits have been from just an
objective source rather than maybe groups that have other interests in
putting out that data.

And, so, it seems to me the USDA has a real opportunity there to use
that data to actually look at what the impacts have been.

MS. DILLEY: I guess I\'m struggling and maybe you can think about some
language as to where the frame is, putting it in the context of future
products, and I don\'t know if there\'s a way for USDA to consider how
to evaluate benefits of future products or something. I don\'t know.
It\'s not \-- it\'s kind of a formulation of a topic. We\'re not making
recommendations. We\'re also talking about future products as opposed to
current. It\'s just trying to walk that kind of formula of how to frame
it.

DR. SCHECHTMAN: And I just wanted to add just one little response to
Alison and that is the Economic Research Service has, in fact, done
several papers analyzing some of that data \-- I think it\'s more than
two at this point \-- from various aspects. Obviously, USDA can always
do a better job communicating, but, typically we come to fairly dry
conclusions about \--

DR. VAN EENENNAAM: As a scientist, to see it appear in the literature
would give an added degree of confidence in terms of the results that
come through for any source. I don\'t mind who does the research as long
as it\'s been through some sort of a POD process.

MS. FOREMAN: I was just going to ask, you know, if Greg was going to
specifically address the research studies about benefits.

MR. JAFFE: I\'m going to try to propose \-- I think there are two
topics. One is Leon\'s topic and I think you could claim that as
somehow, you know, that one of the keys to biotech going forward in the
next five to ten years is better communication about the impacts of the
technology.

And, so, I think that is something that\'s in the purview of the
committee and the charge and would fit in the product as one of the
topics. I also think Dick\'s issue can also be \-- I mean, I don\'t
think \-- clearly, the current benefits will also move forward because
those current crops will continue to grow, be grown.

And, so, I think that is a future \-- I don\'t think we have to look
just at the future products of agricultural biotechnology. We\'re sort
of looking at the future of agricultural biotechnology in five to ten
years and that will still, I assume, include soybeans and BT corn and
things like that. So, I think it is an appropriate topic to sort of say
that one of the issues that it needs to be aware about is those benefits
of those products if they continue to be grown in those next five to ten
years and the impact of them.

So, I think there\'s a way to frame that. It does relate to the five to
ten years and then have the same three or four sentences as these other
ones on it.

MS. DILLEY: I didn\'t hear anybody dispute that that was appropriate.
It\'s just the framing of it. I don\'t have the right language yet.

MR. JAFFE: To me, I thought you were saying if it wasn\'t related to
future products and I\'m saying I think the topic is future agricultural
biotechnology in the next five to ten years, not limit it to future
products. We don\'t know the impact of future products. Although, I
think we can talk about Leon\'s in terms of it\'s important to
communicate the impact. I would use the word impact because whatever
those are, the impact of future products, when those future products
come to market it\'s going to be very important for the Secretary to be
involved in communicating the impact of those products.

But, I also think that our charge is broader than just future products.
It\'s future of agricultural biotechnology five to ten years from now.
We can also discuss the current impact and the benefits of current
products as those will be part of the industry five to ten years from
now.

MS. DILLEY: Carol. Michael, is your card still up? Carol and then Daryl.

MS. FOREMAN: It\'s fine by me if we do this, but, I think it\'s
important to note that there a number of studies that show that efforts
to communicate the value of particular science is simply not absorbed by
the public and it doesn\'t influence them unless in \-- there are fairly
large number of studies about it. In fact, the National Academy of
Sciences in its research work on risk analysis goes into great depth on
risk communication and how it goes right past people because of the way
it\'s usually done.

I think there\'s a limited value to communicating the benefits of
agricultural biotechnology unless the benefits are accrued to the people
that you\'re trying to educate, that you\'re trying to persuade whereas
there\'s not \-- it may reduce opposition in some people to say it\'s
beneficial to farmers. It doesn\'t really make much difference to most
consumers. You say it gives you fruits and vegetables that last longer,
are more nutritious, can be produced more cheaply and those products are
in your store right now, that gets real important. That\'s good for me.

And there\'s a fairly substantial amount of research that shows that
when people think there is a biotechnology product that benefits them
they get enthusiastic about it. Medical biotechnology obviously benefits
people who are desperate for help and they get real excited about it.
Food biotechnology has not earned its stripes with the public in that
regard.

So, I don\'t mind this. I think on the environmental points there are
probably things that both there are benefits and there are benefits that
are important to end consumers so I think there\'s something you can
talk about there. But, I\'m very cautious about promising the whole lot
or trying to educate consumers about something where they don\'t see any
benefit and won\'t share your view of the benefits.

MS. DILLEY: I think in terms of the model that we have we need to
capture something about effective communication and raising that as a
topic and then if the Secretary wants to come back and say, well, what
do you mean by effective communication, we can have that longer
discussion.

But, I think we\'re starting to capture some language that has been
offered in terms of the need for effective communication.

MS. FOREMAN: I\'m not sure because I\'ve heard that phrase really too
many times. When the USDA does effective communication they mean are you
going to sell me \-- they\'re going to sell me on the benefits of
something that doesn\'t really have any benefit for me.

MS. DILLEY: I mean, I just want to make sure the way the format is is
we\'ve got statements on topics and we\'re not getting into a whole lot
of detail because that\'s where we decided to go, so, I think if we\'re
going to have

\-- if the Secretary or USDA wants more on any of these we\'re going to
have \-- we\'ll come back and respond to that.

But, in terms of capturing a particular topic area at least we\'ve so
noted and we\'re going to have do some work in terms of formulating the
exact language as to how we convey it. I just want to make sure that we
have exhausted the opportunity to offer new topics and language to at
least put a place holder there for it and then try and figure out what
our next steps are to work the list of issues that we had.

So, I had Daryl next and then I don\'t know whose card went up when.
I\'ll do Michael and Leon and then Carol. Is that okay?

MR. CORZINE: I just had something quick in response how Carol says
things so profound she turns the music on. I think, me, it captures it
and that\'s why I wanted to go to the environmental part because I do
think consumers are concerned about the environment. And that\'s why
Carol, and maybe rather than even benefit, Greg mentioned impact.

And I think there\'s a place for this evaluation. Maybe peer review and
there is \-- because a lot of things get thrown out there with
absolutely no peer review, so, the peer review evaluation of
environmental impacts of biotechnology.

DR. BUSS: I was going to throw out something to try to capture Leon\'s
point and the suggestion I had was clear and effective communication of
the environmental and public health benefits of ag biotech will be
important in supporting current and future applications of
biotechnology.

From my personal point of view I would, if you make the case for
pesticides, I would see that as both an environmental and a public
health benefit. I certainly see that need.

MS. FOREMAN: I have trouble with that statement.

MR. JAFFE: Can you repeat that?

MR. CORZINE: Clear and effective communication of the environmental and
public health benefits of ag biotech will be important in supporting
current and future applications of biotechnology. And I\'m not trying to
wordsmith to a final form. I think what we\'re trying to do is capture a
topic and then it\'s going to have to be refined just like everything
else we\'ve talked about.

DR. LAYTON: Would you consider a friendly amendment?

DR. BUSS: I don\'t mind.

DR. LAYTON: Documentation of and.

MR. CORZINE: Documentation and communication. Sure.

MS. FOREMAN: To put this real basic, the public health really is not
there. Much has been promised. Virtually none has been delivered. People
read public health as including nutrition and reduction of pathogens and
those things have been promised and not delivered and I\'d just dump
that out and then I\'d be fine with it.

MR. CORZINE: Well, you\'re back to a matter of opinion, I think, Carol,
so, if we have the place holder I think Daryl and I and a number of us
would not agree with your comments, so, we can go down that path, but,
it might be a waste of time at this point. We\'ve got a place holder to
wordsmith just a little bit and we move on. I would object.

MS. FOREMAN: I prefer the place holder doesn\'t have public health in
it. That\'s not documented.

DR. SCHECHTMAN: Please use the microphone.

MS. FOREMAN: The public health is not documented.

MS. DILLEY: You know I have two aspects of this. We\'ve got clear and
effective documentation of communication of beneficial impacts and then
we need to figure out a particular language for that. That\'s right. And
we know we have differences of opinion on the public health dimension of
it. So, we need to work that one any more right now? Okay. I think \--

DR. CROWDER: Carol, I think on the public health thing there\'s two ways
of looking at it. You look at it in the U.S. public may be broader than
you would like. If you look at it in terms of developing countries it\'s
pretty broad and maybe \-- and to the person who is making the
applications of the chemicals in the U.S. and is able to do less of
them, there are health benefits for that person, so, maybe one way to
bridge the gap here is to say health benefits rather than public health
benefits which implies a broader connotation.

I don\'t know what will be acceptable to you or acceptable to him, but,
for the person who is making less applications, having less chemicals
and that type of thing there are health benefits.

MS. FOREMAN: If you want to say health benefits to producers that\'s
fine by me. People read the term public health or health and they see a
much broader definition than what can be documented here. It\'s just \--
it just goes way wide, but, if you want to say \-- you know \-- I think
your point that it certainly improves the health of the people who have
to handle these chemicals I absolutely agree and I\'d be very
comfortable with the phrasing that makes that clear.

MR. SHURDUT: I know I\'m going a bit out of order, but, it is responsive
to this. I think it is important to keep public health in there because
there are some healthy products out there and I can speak to products
that we have and those that are already on the market that there is a
public health aspect as to healthy oils and other things. So, it\'s not
just the chemical and reduced chemical use. There are some things that
we can illustrate from a public health perspective and I think it is
important to keep the public health and not just the health for those
reasons.

MS. DILLEY: I guess the question along these lines is, is it important
to name or elucidate every type of benefit that could be helpful to
document and communicate and it may be broader than environmental or
people\'s different definition of health, but, I don\'t know, if it
helps to clarify it or it makes it more confusing.

Ron?

MR. OLSON: Yeah, I\'ll add just one thing. I mean, we test because of
pesticide residue throughout the manufacturing process and you\'ll
notice a reduction in that. Some chemicals, you know, dissipate quicker
than others so there is some pesticide effects, but, nobody \-- I don\'t
know if there\'s a food manufacturer that\'s going to actually share the
data or publicize it, but, my food has less pesticides than yours, and
it\'s a hard thing to market.

So, but, I think there is a reduction that does transfer through on a
broader than just the guys who are putting the crops on.

MS. FOREMAN: It\'s not going to satisfy Brad, I think, but, the
environment and health effects of reducing the use of pesticides in
agriculture.

(Discussion off the record)

MS. FOREMAN: The environmental and health benefits of reducing
pesticides in agricultural production. The environmental and health
benefits of reducing pesticide use in agricultural production.

DR. CRAMER: I\'ve been patiently sitting over here with my card up, but,
I think that part of what we do in this five to ten years, and we\'ve
all spoken about how the fact \-- what we would really like to do is
have a consumer pull that actually is going to be reduced fat french
fries or vitamin C lettuce. And, so, my feeling is we\'re not talking
just about what\'s out there already and we don\'t need to do that
argument.

Our goal is that as these things develop we want to make sure that those
benefits are effectively communicated. But, that wasn\'t why my card was
up.

DR. LAYTON: And that\'s why I said document. I mean, I think that that
really makes a difference is that you collect the data and it is
transparent, it is open. So, that was why I added document.

MS. DILLEY: What, Greg? You\'re shaking your head no.

MR. JAFFE: I mean, the question of the document, I mean, these are not
recommendations, so, are we just saying that documenting and
communicating impacts will be very important to the technology in the
future? We\'re not telling USDA to document it. Okay.

DR. CRAMER: Well, this is just if we\'re going to go away from issues.
Basically I\'m going to punt, but, it seems to me that some of the stuff
that Pat said today about the forest industry and biotechnology was
actually very interesting and surprising and not something that was
obvious to me and I think a lot of other people.

And I don\'t know if there\'s actually an issue there or a topic of
discussion that should be put forward that there are special issues in
forestry, forest products.

DR. SCHECHTMAN: If I can just make a little response. I think Pat noted
the fact that we explicitly tried to not talk about trees or fish or
insects largely in this report. Now, you know, that doesn\'t say that
you\'re bound to keep it that way, but, that was certainly the original
intent and undoubtedly there are a bunch of very interesting issues
related to trees. I\'ll just sort of throw that out there.

DR. LAYTON: And insects.

DR. SCHECHTMAN: And insects. Certainly there are a whole number of
those.

MR. JAFFE: I mean, my view is, I mean, that was our own internal
limitation when we were really talking about a much bigger scope paper
and lack of expertise, but, I think if it\'s the committee\'s view that
trees are going to be on USDA\'s doorstep they would be the primary
regulator for them in the next five to ten years then at least alerting
them to that fact that there\'s a lot of research going on that there
may be products before them and that there may be a range of
environmental or other issues associated with them in a three or four
sentence thing I think we shouldn\'t be bound by that previous decision
where we were talking about it on a different level.

I feel more comfortable with that than going into insects, which I think
is a very different thing and I don\'t think USDA plays a major role,
although I think they could have, could have impacts. Tangentially, I
think we\'ve talked about transgenic animals and things like that, but,
I\'m not as comfortable going there, but, I think because Pat is an
expert on the trees and has some feeling for where that industry is
going I think it would be appropriate to put that down as a topic with a
three or four sentence discussion pointing out that this is on the more
immediate horizon.

That\'s my understanding of the research that\'s out there that there is
a fair amount of field testing that\'s going on and for different kinds
of trees and those will be not just fruit trees also in addition to
trees for lumber and so forth.

So, I would recommend that we rethink that.

MS. DILLEY: Go ahead.

DR. SCHECHTMAN: I don\'t have a problem with doing that. I do want to
make two points though. One is that there hasn\'t been a lot of \--
obviously, there hasn\'t been a lot of discussion about this and I think
there might be other issues along those lines that are different that
are like the trees, so, I\'ll just say that as one thing.

And the other thing is just to add a little bit of fact that with
respect to insects, USDA actually does have a major responsibility. So,
I\'m not suggesting that we start up, that the committee start up on
that today, but, it is a major \-- it\'s more \-- it\'s a more clear
responsibility to USDA than to anybody else.

MS. DILLEY: I\'ll add, does anybody have a problem with adding language
on trees and then we\'ll probably have to up front just say what we
maybe didn\'t talk about or the scope of what we did? Jerry, you had a
hand?

MR. SLOCUM: Well, Pat, when you mentioned trees you mentioned it in the
context of co-existence. Is that the pressing issue for trees at this
point? If it is, then we certainly need to address that in the
co-existence topic that the Department wants us to flush out in 2006.

DR. LAYTON: It is one of the pressing issues. I\'d actually like to
think about it and talk to a couple of my cohorts to make sure that I
have that and suggest something via e-mail to all of you, if you\'re
comfortable.

MS. DILLEY: Greg?

MR. JAFFE: My understanding of trees is one of the big issues is how do
you deal with field trials and how do you deal with getting to the
commercialization stage of products that take a long time to grow to
times when they start reproducing and is the data requirement different?
How do you deal with some of the pollen issues? So, I think of it less
as a co-existence.

I mean, I\'m not saying there isn\'t a co-existence issue when things
get commercialized, but, I think there\'s really an issue of how do you
\-- how does one conduct their research towards commercialization for
genetic engineered trees which have \-- and how does one assess those
risks and how does one manage?

I mean, for field trials or other kinds of things do we manage them, we
plow them under the one \-- you know \-- you do one row of corn, you
plow it under afterwards. Trees are of a different nature and I think
those are issues which I think you have to grapple with to some extent,
but, obviously, Pat is raising a concern that the industry feels that
they\'re being hand strapped for other aspects of that. They\'re not
really being \-- it is hindering the development.

MS. DILLEY: I would take up Jerry\'s and Pat\'s response to that in
terms of suggestion of it\'s an area that people are uncomfortable
venturing into because it\'s obviously of importance to at least one
member of the committee and that it will be before USDA over the next
five to ten years that maybe you can consult with your colleagues and
put something before the committee to consider for language to the
report. Okay.

Any other issues? And, Michael, you had a process suggestion?

DR. DYKES: I was going to introduce one more topic and I\'m not \--
being the time, on these other things I don\'t have a crystallized
statement to make with it, but, I think if we look in the next five to
ten years and we look at what we\'ve seen in terms of alternative
energies we see the changes and focus on alternative energies and we see
that \-- sorry?

MS. DILLEY: As we see gas going up to \$2.50 a gallon.

DR. DYKES: As we see gas continuing to be expensive and the
modifications are going on in terms of oilseed crops, modifying oil
content, modifying protein content and the shift that\'s going to have
and even on the other side I think there\'s some transgenic products on
amylase corn there are going to be some \-- again, there are going to be
some modifications.

This whole energy issue will drive some changes. The Department of
Agriculture\'s going to be much more involved in than they had been
heretofore and it will have some implication for ag production as well
because I think we now have another, I guess, driver or market for
agriculture production that heretofore we have not had.

And I think that\'s another implication we need to be thinking about
that technology is going to drive.

DR. SCHECHTMAN: I think one would be here gloating, smiling broadly
after he had, you know, brought up all of those topics in the scenarios
and in preparing for the future as we watch the gas prices doing what
they\'re doing and the new focus on some of the alternative energies
from bio-energy.

DR. DYKES: My point on that too is with the passage of the energy bill
it\'s now gone from debate and discussion to we\'re making policy on
that as a nation. It\'s gone from theory to policy.

MS. DILLEY: Carole.

DR. CRAMER: Again, this is one I have no clue how to articulate and we
may not even want to touch on it, but, if we look at the products that
will be around in the next five years, but, maybe in ten years, one of
the things that\'s happening in molecular biology are alternatives for
additives, say, involving RNAi where you actually knock out an existing
function. And in some cases it can be virally vectored that\'s
temporary.

So, my question is, does that \-- will any of these new technologies on
a real technical, in a laboratory now basis, create new regulatory
issues or require new definitions of what we call \"transgenic\" or
recombinant. And, you know, is this something that now we should start
having an issue. And, you know, you just reach the depth of my
knowledge, but, I just throw it out there, is that something that we
want to sort of put on their plate to say that, you know, there\'s a new
generation of, you know, triple helices that knock and create mutants
and stuff like that and is that something we want to put on this list at
all?

DR. DYKES: I mentioned that earlier and that\'s where my thinking was
about tolerances in RNAi and that\'s where I mentioned is the Department
thinking about, are they prepared for the coming next wave of products
that won\'t be the traditional gene insertions. I had that all
encompassed in that. But, I agree with you, it\'s something that needs
to be thought about.

DR. CRAMER: If I can just follow up. I mean, from that point of view
there may be changes in how one could text it as well and, so, the
common \-- you know \-- when we look at testing and standardization of
testing protocols there may have to be, you know, new approaches to
testing and may need to be phenotype based because the pieces are \--
so, that might be something that we kind of play with as far as the next
generation of technology that will be moving into ag product.

DR. DYKES: Even more thought provoking it may be the absence of
something rather than the presence of something.

DR. SCHECHTMAN: I\'d just point out that I think Pew held a workshop on
this question.

MS. DILLEY: Any other topics?

DR. CRAMER: Do we have that formulated or some little word? I mean, as
an issue. Okay.

DR. LAYTON: It\'s RNAi.

DR. SCHECHTMAN: Let me do a couple of procedural things if I can right
now. One is to mention that we just learned that that little bit of
noise that you heard next door was a prelude to, in fact, what is going
to be a walk through luncheon with 300 people and music next door from
1:00 to 2:00 so what we would like to do is take a very short break,
come back, and work until 1:00 because we would probably not \-- work
until 1:15 because \-- we\'ll have to work until 1:00 and then we\'ll
come back at 2:15 because we will need to be able to hear each other and
I suspect we won\'t other than by doing that.

If people are okay with that suggestion.

(Discussion off the record)

DR. SCHECHTMAN: We\'ll take a quick break first though.

(Discussion off the record)

DR. SCHECHTMAN: Okay. The one other point that I just want to mention to
folks since I know we\'ve gone through this issue process, but, I want
to mention that it hasn\'t completely gone through, you know, all the
paperwork has not yet been registered where it needs to be, et cetera.
But, there\'s going to be one more member added to the committee. The
Secretary has indicated that that is at this point adding one more
member who is a representative from the National Farmers Union from
Missouri and he will be joining the committee.

He thought that he was actually going to be able to be here as an
observer for this meeting, but, he wasn\'t in the audience, but, that
should be starting at the next meeting so we\'ll need to afford him an
opportunity as well to consider the issues list. I just wanted to
mention that.

MS. DILLEY: So that will bring the total number to?

DR. SCHECHTMAN: That will bring the total at present to 19.

(Whereupon, a brief recess was taken)

MS. DILLEY: I just want to get a sense of people\'s schedules.

(Discussion off the record)

MS. DILLEY: Okay. That just gives us a sense of the day and allocating
the rest of the day. Carol, just before I come to you, there are a
couple of things we still need to get to, make sure we spend time
talking about.

First of all, I was just talking about some other concepts for the rest
of the report. We\'ve talked about the issues section and we\'ve talked
about a much reduced paper overall or referring to it as a paper instead
of a report in some respects. So, just trying to get a sense of what
other portions of the paper do we need, what that looks like.

I also want to talk a little bit about formatting for the issues because
we are now up to approximately 28 topics. So, one thing we need to be
clear about when we talked about it needs to be four sentences or under
per topic, we\'re talking about still a fair amount of text and a fair
amount of work because these are all place holders at this point. It\'s
not finalized language. We all know how long it\'s going to take to get
to finalized language.

So, we need to talk a little bit about commonality of approach and
format for those topics as well as any other portions of the report that
we need to pin down a little bit just so we have a vision of what the
overall paper is going to look like and how we make progress between the
end of this meeting and the next meeting.

So you need to have a work plan basically between now and then with some
clear direction on where we\'re trying to get to.

The other thing we want to spend a little bit of time on is we passed
out the new topic, at least get a little bit of discussion on those
topics, to start thinking about formulating that and how the committee
might want to approach those charges. Anyway, a little bit of time to
just understand them, et cetera.

(Discussion off the record)

MS. DILLEY: So, and I think those are things that we need to discuss
before we conclude the meeting. Is there anything else, Michael,
something on your pad, or, Cathy? Okay. So, we just need to allocate our
time on those things.

Carol, I don\'t know if you had a process suggestion or you wanted to
raise.

MS. FOREMAN: When are we going to talk about the new issues, when
Bernice gets back?

MS. DILLEY: I was thinking to do that now so we can conclude our work
plan for the day.

MS. FOREMAN: Okay.

MS. DILLEY: If we could pick up when you think about 28 topics, four
sentences or less, we obviously have to have some kind of commonality to
how we\'re phrasing those questions as well as formatting for that. I
just wanted to see if people had a concept that they want to toss out, I
mean, other than some may be one sentence and some may need the full
four lines to get us there.

Pat, you want to \--

DR. LAYTON: I wanted to pick up from something Daryl said yesterday. He
did suggest that there was some grouping of things in a topic or topics
that would be, you know, sort of there\'s the regulatory grouping and
then there was maybe the harmonization and testing grouping and then
there may be a couple on research that were grouped together.

And, so, I wanted to ask if that concept is still okay with everybody
rather than just random without giving any sense of order or is there an
order. We certainly didn\'t have an order of importance in the last
global traceability and labeling and I just wanted to see if that was
okay.

MS. DILLEY: I think in my mind the question, because we\'ve tried
various iterations on that, is, if the benefits, I guess, outweigh the
potential costs of spending a whole lot of time reorganizing and if
there is kind of a likely fallout as in the categories then maybe
that\'s helpful but I want to make sure that we don\'t devote our time
in arguing about formatting and grouping as opposed to adding some
structure to the report.

So, maybe if there\'s a way of taking the first pass at that, but, if it
becomes too complicated we just kind of drop back to the \-- but, I
don\'t know, Michael.

DR. SCHECHTMAN: I was just going to make a suggestion for you to think
about, of assuming at the moment for the purposes of writing them up
that they\'re in a random order and then we can go back and look at them
and see if there\'s an order and a grouping once we have them.

I see Daryl nodding his head.

MS. DILLEY: Does everyone agree to that?

DR. HUNT: I don\'t disagree with that. I think what may happen is once
we put them in chapter 2 we\'re going to reduce that much down. It may
be that we can develop some structure in that which then reflects a
similar structure in the way we organize the issues. It may fall out
naturally.

MS. DILLEY: Okay. So, I think why don\'t we assume, as Michael said,
let\'s work on the statements or the topics, the language, and then if
there is a natural way to group them and it can be easily done then
we\'ll consider that later on in the process.

Are there other thoughts in terms of phrasing? We know we\'re not trying
to frame these as recommendations, but, I guess if there are any
thoughts in terms of how to have consistency among the topics and other
formatting considerations that are important. I don\'t want to get into
language so much, but, just consistency which I\'m aiming for
consistency here.

Michael and then Carole.

DR. DYKES: I was just going to comment, I think the kind of path we\'re
on is three or four sentences underneath the issue statement so that you
can read and it\'s kind of clear to you what the aim of the committee
was. And I think another thing we have out that these are not \-- there
are no recommendations in these.

I think another one is that I think we had this in previous
conversations of this committee, no value judgments on them. They\'re
kind of just as statements that stand on their own, that stand alone.
So, I think we\'re guided by that and then we should be able to make
three or four statements and some may take less than that to know what
the committee is trying to convey with that particular topic statement.

MS. DILLEY: Carole.

DR. CRAMER: You can tell I\'ve moved into administration because I\'m
sort of thinking of it from the point of view of an Excel spreadsheet.
But, if we were to sort of like imagine an Excel spreadsheet with column
one being the issue statement; column two being sort of key elements of
why it\'s an issue; element three being, column three being, you know,
if the opposition \-- if there\'s other views and the final one being
why we think it\'s important for USDA just as \-- but each one being
nothing more than a sentence.

So, if we were to do something like RNAi which we have never talked
about so I\'m not going to push anybody\'s buttons but sort of say
there\'s new technology that, you know, may have to do something or
other. The issue might be there\'s going to have to be new technologies
for testing and assessment and terminology that USDA needs. That might
have been a bad choice.

But, so, that\'s sort of the idea that if you\'ve got sort of a
structure in here, Excel thing, then you say well, what\'s our major
sentence here, major sentence there, and you try to be at least
consistent.

DR. SCHECHTMAN: Yeah, I think having heard some of the discussion from
some folks I\'m not sure that being quite so rigid as to one sentence
for this and one sentence for this is necessarily going to fit perfectly
for each one. And I just want to, you know, offer the possibility that,
you know, conceptually that\'s not a bad idea, but, we need to offer
folks perhaps a bit more flexibility because in some cases people may
feel there needs to be, you know, a few sentences explaining why it\'s
an issue, or, giving an example, so, I think that\'s a way maybe to help
think about it, but, not necessarily \--

DR. LAYTON: We talked about these. Right now there are words out beside
it in bold with bullets is issue. We talked about them as topics. Did we
come to a decision on what word we want to use?

MS. DILLEY: Topics.

DR. LAYTON: Topics is what we\'ve decided. Topic.

MS. DILLEY: I think topics of discussion is how we were going to be
labeling that section. Dick?

DR. CROWDER: Picking up on what Michael Dykes said and what Michael
Schechtman just said in terms of guidance on this, Michael Dykes listed
three things for consideration in terms of how we approach each of these
topics and then based on what Michael said it was a comment or I think a
philosophy yesterday that it would be short, whatever they are.

But, then I guess the last word in terms of describing these, at least
in relationship to each other, there was a perception of at least
balance in them and whether that balance takes one statement or two
statements, Michael, but, I think it\'s a subject matter balance rather
than a one sentence per se, or, two sentence per se, but, the issue of
balance should be respected all the way through.

So, in addition to those two I\'d say, you know, shorten is the
objective and balance is a must.

MS. DILLEY: It\'s kind of a balance as well as just pragmatic. At 28
topics, you know, so, make sure it\'s balanced and short.

DR. CROWDER: If I may, I think we\'re getting pretty long in terms of
topics and I don\'t know how the list of those that we agreed to add in
in addition to these, I don\'t know how many we\'ve got in terms of
total of what\'s included in the 28. But, if there is any way that there
can be consolidation as a group we ought to look for that.

It would be much more readable and much more usable and be read by
higher ups rather than saying giving it to \-- delegating and say
you\'re going to read this and let me know what it is. We might be the
best filter for this rather than having someone else filter it later on.

DR. SCHECHTMAN: Yeah. I just would add, I mean, I think that\'s
important, but, I think it\'s also going to be we have to look at them
all and look at the four sentence versions of each before you can decide
to do that. I think I would add one other point in thinking about
writing some of these. And that is sort of a request to folks who write
the issues to attempt to, what\'s the word, anticipate the disagreements
that will occur on the text so that in addition to saying it\'s
balanced, I mean, if it\'s an issue that\'s going to require, you know,
indicating that there are opposite points of view, that there are
different points of view, you know, don\'t shy away from doing that.

It takes away, you know, one step in the committee in talking about
things. So, you know, if the end result is likely going to have to be
acknowledged and that there\'s more than one point of view we start with
that and I think there are a few issues that may fit that category. That
may be a lot easier.

MS. DILLEY: Let\'s try and find a statement that everybody can agree to,
taking different points of view into account. Okay.

DR. SCHECHTMAN: Let me just add something to that. I mean, I think there
are instances where there will be statements that everyone will agree
to, you know, by compromising from both ends and there are statements
that, you know, may not necessarily come out that way, so, people are
going to have to sort of be aware of thinking about those things in
moving into the writing, however we actually get to the writing part of
this.

And I guess we\'ll have to talk about that coming up.

MS. DILLEY: Other thoughts on formatting? Okay. Michael, any other?

DR. DYKES: I was going to raise my comment earlier, try to get to where
Abby is, can we get statements. If they\'re not recommendations and
they\'re not as best we can genuinely try not to have value judgments in
them, hopefully we can have statements that just make a statement.

MS. DILLEY: The next challenge is to get something in black and white
and then the committee can take a look at. But, before we do that,
before we start talking about work assignments or how to actually do
that, I think we need to look at the other portions of this report and
we talked about the concept of eliminating chapters per se and really
having a paper.

But, there obviously still are some sections of a paper so we\'ve got a
list of topics, the topics of discussion and there\'s some amount, some
of the introduction part of the committee that we\'d have on the other
reports too. We came, we met, we worked together, we had some of our
meetings and this is a result of those and some of the process pieces of
it.

I guess the question then is, what other portions, and I think, Michael,
and the proposal there was some kind of more briefly discussion of what
future products are anticipated in the next five to ten years and then
the question was is there anything more; what do people think about that
in terms of characterizing that; the concept for that; and then anything
else that needs to be included as a prelude to the topics for
discussion.

Did you want to add anything to that?

DR. SCHECHTMAN: Yeah. I think that one portion of the introduction, of
what was the introduction we addressed in the discussion earlier about
benefits, and making that a topic of discussion so that can be included
in that topic of discussion list.

The portion of original proposal, again, just to sort of run through the
pieces of what was there before, there was a piece on the promise of
biotechnology. I\'m not sure that for the report as it\'s constructed
now that actually is needed. There is the piece about future products
and that was written, I don\'t recall, a year and a half ago or
something and that, I think, certainly needs to be re-visited to see if
some predictions are now old hat, or, are wrong, or, that are others and
I\'m not sure who will know best about it, with the section that\'s
called the next decade of biotech products in that version in chapter 2.

So, I think we\'ll need a process to figure out how to go back over
that. That was one intent that we really never talked about in great
detail, in here anyway, and that was my attempt to capture what I had
heard from information from various companies and from international
organizations as well.

MS. DILLEY: There\'s really two questions. Let\'s just take that piece
for now. Is there some value in having a description of future products
and then if the committee says yes then we can talk about how we update
it or fine tune it.

So, the first question, you all think it\'s essential to have a
description of future products? Michael?

DR. DYKES: I think there is. Going back to Chapter 2 may not be in the
same length. It obviously needs to be updated, but, I think there is
some need to kind of build some kind of context for where we have been
with biotechnology and then where do we foresee the next five to ten
years taking us and then there\'s a subsequent piece to that that would
be some of the other topics that have been discussed which, I think, has
a blend of how we dealt with them previously, what other topics need to
be addressed with the coming five to ten years.

So, the topics that stand both of those as well. So, I do think we need
to have some chapter that kind of fills that context for what has been
and what\'s likely to be.

MS. DILLEY: Carol?

MS. FOREMAN: Yeah. That whole chapter is 13 pages long and there are
about four pages of that, four or five, that are potential products. And
I think they\'re overly optimistic in some cases in describing them and
in no case does it say this is a potential new product and that may
arouse opposition.

For example, animals are being developed to serve as animal models of
human disease and I think there\'s a reference in there, I may be wrong,
I thought there was a reference to cloning animals for human organs.

I think we have to include that we have to say somewhere that these are
things that have been mentioned but may not go forward because they will
arouse opposition. But, I think this whole thing can be substantially
shorter.

MS. DILLEY: I don\'t hear any disagreement with an abbreviated section
and the question is really kind of what\'s the nub of, the real core of
what that section looks like and what has been and what are likely to be
in terms of describing the types of products and then understanding that
these are projections and whether they actually are produced in the next
five to ten years there are a lot of factors that go into that; whether
conjecture becomes reality in terms of opposition or other issues,
topics that are mentioned in the next section.

So, that seems to be kind of the core of the overall flow of the report.
I guess I\'m just \-- is there something that\'s missing that we
haven\'t talked about that\'s really necessary to lead up to that
section or anything else that people think is important to make sure is
on the table as part of the preliminary section to the report.

Yeah, did you want to comment? And then Dick.

DR. LAYTON: I guess I wanted to ask about the benefits piece which is, I
think, current impacts of adoption. That\'s just going to be gone pretty
much.

DR. SCHECHTMAN: That\'s going to be a topic of discussion. That will be
added as a topic of discussion.

DR. LAYTON: Discussion?

DR. SCHECHTMAN: Yes.

DR. LAYTON: Okay. So, does that mean that you\'re dropping the bottom of
page 2 through 9? Okay. So, that\'s pretty much all gone.

DR. SCHECHTMAN: No, actually from 6 through 9, from the very, very
bottom of 6 there\'s a new topic.

DR. LAYTON: Oh, the promise.

DR. SCHECHTMAN: Yeah and that \-- we still have yet to discuss exactly
how to deal with that.

DR. LAYTON: Okay. So, 2 to 6 is gone?

DR. SCHECHTMAN: Yes. It\'s gone from an introduction. It\'s moved as a
topic of discussion, to the topics discussed section.

MS. DILLEY: To the degree that we can, I\'d rather put the vision out
there, outline it, and then pick up what we need to \-- I don\'t want to
back into the formatting of the report in terms of what\'s dropped and
what\'s kept. Let\'s come up with a concept that everybody agrees to and
then we can pick and choose what\'s there can fit into or not fit into a
revised document.

Dick?

DR. CROWDER: Okay. I agree with what was going on in terms of the pages
in here. Those pages have gone. The topics that were discussed stay.
I\'m just going to make \-- pull something out following up on the
future. I think we have to have something perspective in here and I
think that just in terms of process we have company representatives and
we have scientists from universities and so forth and it may be that
group could get together and take a look at what we\'ve got in terms of
what was written here versus \-- and that was almost two years ago, I
guess, or, is how they see things now, some things are progressing
faster, some things are progressing more slowly \-- to revisit that to
see how to shorten it and make it \-- and update it would be something
that might be worthwhile.

Because I agree, Abby, that, as you said, it\'s worth having, but, I
think an updating would be appropriate given how many changes have taken
place.

MR. GRANT: So, we\'re trying to put together a list of topics and a
response to where this issue may be five to ten years ago, but, I don\'t
know if we can really do that unless we emphasize the promise. Failing
that, I just can\'t see how we can get to a rational discussion of what
the future might look like and what the topics might be unless you
emphasize the promise.

If we emphasize all of the reasons why we won\'t achieve the promise
then the topics really become moot points. And, so, recognizing that,
perhaps emphasizing the promise doesn\'t give equal balance to the side
that says the promise is going to be difficult to achieve or may be
over-sold, et cetera. Nonetheless, if we don\'t frame it as a potential
promise then the discussion of the topics, to me, really loses a lot of
its relevance and our ability as a group to offer a good discussion of
the topics becomes limited.

MS. DILLEY: I guess I just want \-- I don\'t think the promise dimension
of it is necessarily lost even though if it\'s not in a section. If
you\'re talking about what products have been developed and what are
future products you talk about their applications. And, I would imagine
that highlights some of the promise.

I guess I\'m trying to understand what in addition to that and then kind
of the carryover of whether, in fact, these products are commercialized
depends on a variety of factors in terms of whether you can actually
realize that promise or you\'ve got other factors that are including
some of the things we talked about in the preparing for the future
piece.

So, I\'m trying to understand what section isn\'t quite there that
you\'re looking for that needs to be a separate section other than
describing future products and their applications that doesn\'t already
elucidate some of that promise.

MR. GRANT: So, I\'ll respond, I guess. It seems to me there are really
kind of two ways you can do this. You could kind of build a narrative of
where we are today and you could say, you know, we\'ve seen
commercialization in the U.S. We\'ve seen commercialization in Brazil
and other areas. We\'re seeing some new products come on line in China.
At the same time we\'re seeing strong resistance in the European market.
We\'re seeing resistance in other market blocs. And you could kind of
establish a narrative of where we are today and then move into the
issues.

But, I think that\'s into the topics of discussion, I think as we\'re
calling them. But, I think that\'s a much more limited way to approach
looking at this five to ten years out than to develop a good narrative
of what the promise could be and then from that narrative illustrate
what we think the topics will be.

Because if we just build a narrative of where we are today and give
equal weighting to all of the issues that are out there today I think it
distracts and alters the direction of where we\'re headed to in the
future. The light that\'s shining on these issues today is not
necessarily the same focus that they\'ll have five years out.

DR. CRAMER: I guess I\'d like to throw out as well is your initial
rendition of this we had the scenarios chapter as the final chapter and
a lot of the things Duane is just bringing up is sort of in the context
of the scenarios and the fact that we\'ve got different directions than
what USDA has the ability to impact those directions over the next five
to ten years.

So, we might want to think about in reducing this introduction to sort
of tie it back to the scenarios chapter and say, you know, we provided
with a report that raised these issues. Here\'s our deliberations on
some of the topics of discussion for which the resolution of these
things may impact which one of the scenarios is born out so that we can
without putting all the text in this tie it back to the deliberations
that we\'ve done.

MS. FOREMAN: That\'s exactly \-- I agree. It also \-- I hadn\'t thought
about it, but, does the scenarios chapter give us an organizational
structure that it\'s possible for us to apply to this one?

DR. SCHECHTMAN: Microphone.

DR. LAYTON: I actually sort of had an organizational structure I was
going to suggest. If you begin the chapter with a description of the
AC21 and why we exist and then a brief introduction of who we are, you
know, with some discussion of whose on the committee, and then move to
\-- I thought about the where, but, that might mean that we held nine to
ten meetings to date or something like that, mostly in D.C., so, I went
back to journalism here.

And, then, finally, my biggest issue then was the whats and in that what
piece we describe that what we did was review a series of, you know,
materials and topics and things like that. We had people come in and
speak to us. We had different groups that we all have produced two
topics, two papers already, or, two reports to the Secretary and that
some of the issues that, you know, just maybe a few sentences about what
those are about and how they\'ll relate to what the final report of the
committee is which this is it and then it finally, culminating from that
discussion, we developed a list of topics that we believe are important
to USDA and to agricultural biotechnology in the 21st Century and then
that just leads us into our list of topics.

And, then, you know, as a concluding paragraph we, you know, submit this
to the Secretary for his consideration basically. So, really kind of
going with that, why, who, or, who, why and the what, and the what is,
at this point in time, the what is the first two projects we\'ve already
given to them and then finally the list of topics and their somewhat
small, limited explanation and that\'s it.

DR. SCHECHTMAN: So, are you suggesting then no talk about potential
future products or promise?

DR. LAYTON: I would suggest that in the discussion of what we did we did
do a review of potential products and we mention that. We can list some
of those briefly in that discussion. But, that\'s \-- you know \--
that\'s, you know, not five pages, it\'s, you know, a succinct
discussion of that. That we had done some work on looking at what\'s
been done to date, please see ERS document X, Y, Z on impacts and please
see X, Y, Z list on things like that that we did do those things, but, I
don\'t think we have to expound on the buildup of knowledge gathering
that we did as a group to work together because what\'s really important
is the final list of topics.

And, then we\'ll move into other pieces of work or more detail on some
pieces of work or something like that. Just a proposal.

DR. DYKES: I just want to comment on the dropping of the pages 2 through
6. I would like to reserve on that to see just how we\'re going to deal
with that in the topics that\'s been discussed section. Because I think
as part of building a context for the past ten years it is important
that we have some, maybe not four pages, but, we have some of that so
before we leave here with a conclusion we\'re just going to drop all
that, I\'d like to reserve judgment on that for my own personal
standpoint.

Because I think it\'s important that it be captured somewhere, maybe not
in that volume, but, somewhere in order to give a context we\'ve got to
\-- we need to include something on that and I may be alone in there,
but, I don\'t want to leave saying that I have agreed that we\'re going
to just drop all of the comments about benefits.

MS. DILLEY: Duane and then Carole.

DR. CRAMER: I agree and I think that a lot of what Pat said is what\'s
listed on this thing as chapter 1 which I think we can consolidate a
lot. I think that they\'re important points and we\'ve already done some
work in organizational thought in chapter 2.

But, I think that this can be shrunk significantly. So, if we just look
at our headings and take what\'s there and put it into, you know, shrink
it to a single paragraph that sort of highlights some of the points I
think we can cover. You\'ve got recent history. Then you\'ve got current
impact where it at least gives an opportunity to mention improved soil
improvement, conservation, and pest management, yields, and then the
promise of biotechnology where, again, it just goes into a relatively
small, but, you take the same format, you just write a really crunch so
you\'ve at least got those points.

And, you know, do the same with the last section. We could even consider
taking sort of the next decade into a table format where you just say,
you know, in the area of nutritional enhancement these are, you know,
possibilities and you could even say likely or maybe, sort of table.

But, then you condense it into a very accessible and readable form that
takes 12 pages and brings it to four page table.

MS. DILLEY: You\'re basically suggesting that take the same format, just
shrink it?

DR. CRAMER: Yes. Seriously shrink it.

MS. DILLEY: Duane and then Carol?

MR. GRANT: So, I guess I first put my card up because I wanted to
respond to what Pat was suggesting and I don\'t think that\'s, from my
perspective that\'s not the way I would take it. I don\'t think \--
well, we have done a lot of deliberation, a lot of work, I don\'t think
anybody else is really that interested in that. I think what they\'re
interested in is the product that we put out, and to the extent that we
can, the observations, the collect wisdom that we offer towards where we
think the USDA should drive in the future.

And that\'s why I really don\'t want to back away too far from putting
emphasis on the promise. In the scenarios document we had the
opportunity to lay out three very distinctly different futures and none
of us really bought into any one of those particular futures. We kind of
bought into different areas of each one of those, but, none of us bought
into any one of them.

In the promise, I think it gives us a chance to kind of lay out a
vision, if you will, of where this country might go with this technology
and then building on that, these are the topics that we discussed as we
look at where this country might go. I don\'t think we can put it in the
framework of a recommendation of where this country might go, but, we
can look to the future and say these are areas where we think there is
significant promise; that this country really could develop and the USDA
could focus on developing; and these are the issues that come up when
you start thinking about how we go about getting there as a country and
as USDA as an agency.

I think that would be a real useful document. If we have to boil that
down to where it\'s just in the form of a matrix, that\'s a pretty
sterile way to do it, but, I would at least accept that rather than
moving completely away from the promise.

MS. DILLEY: Actually, I may be missing something, but, I think though
one huge challenge that you\'ve put out there is I don\'t think this
committee is going to reach a consensus on a common vision. I think the
committee is made up the way it is to have the diversity of
perspectives.

So, I think if part of the effort \--

MR. GRANT: Can I stop you for just a second?

MS. DILLEY: Sorry. I may have misinterpreted what you\'re saying.

MR. GRANT: I\'m not looking for a common vision at all. I fully agree on
a common vision, but, can we agree on common potential promise, all
right, that there is potential value in this technology that can be
realized, that can be discussed, and articulate a potential promise?

MS. DILLEY: I don\'t know. That\'s a question for the committee. Carol,
I think you were next and then Alison.

MS. FOREMAN: I\'m not sure we can, particularly not by the end of
December. I\'m willing to try, but, I\'m not very hopeful. I liked
Pat\'s formulation for a couple of reasons. One, it\'s precise. It gets
us through. It boils it down; references a scenario and placing the
labeling and traceability chapter.

And by saying that these are some of the things that we got in
presentations, if most of what\'s here could be boiled down and
presented that way and then all the committee members don\'t have to
endorse that language as something that we accept. Another thing, that
it got made as a presentation. It was stuff we studied. And there were
some people who were a little less sanguine in their presentations and
that should probably be noted as well.

So, as a way to get this done in two more meetings and by the end of
December I think that\'s realistic.

DR. VAN EENENNAAM: I just had a comment on the promise of biotechnology
section. It includes several paragraphs pertaining to application
unrelated to genetic engineering such as genomics and marker selection.
I think Richard focused his report on genetic engineering because
that\'s what it\'s about and that\'s a way to at least cut out some of
the language.

MS. DILLEY: Dick, comment?

DR. CROWDER: Carol, I guess I would be a little more optimistic on the
ability to reach some type of consensus on promise. I mean, I think it
would be almost unfortunate if we could not find some statement here
that said biotechnology \-- agricultural biotechnology has some promise.

The extent and how you quantify it and maybe it\'s not, you know, in
terms of the specifics and so forth, but, that\'s a pretty strong
non-statement, if you will, if this group cannot agree that there\'s
some promise in agricultural biotechnology. We may not be able to
quantify what it is, but, we ought to be look at some area or something.

I would support Duane\'s idea, but, the position that at least it ought
to be examined and not thrown out before we at least give it some try
and I know we all have a difficult time agreeing on exactly what it is
and where it\'s going to come and whether this particular item is going
to come and this particular time and so forth. But, if someone says
could the committee agree that agricultural biotechnology had some
promise and the answer would be no, that\'s a pretty strong statement.

MS. FOREMAN: I\'ve always started all my speeches on biotech by saying
agricultural biotechnology has enormous potential promise and then I
always go through and describe what some of those are and then I say and
these are the things that could screw it up. So, if we\'re open to the
statement of what precautions ahead are then I could probably agree to
having it. I\'m not sure that we can.

DR. CROWDER: I would encourage us \-- I\'m not going to be at the
October meeting. I don\'t know what\'s going to happen between now and
October, but, I would encourage us to have that conversation that we
just got through talking about and what Carol just said. I don\'t know
where it will end up, but, I\'d rather have the conversation and come to
a conclusion than not have the conversation and come to a conclusion.

I don\'t think any of us think anything that is certain and given and it
falls along the way, but, I would encourage the group, at least in the
October meeting, to at least have that conversation.

DR. LAYTON: I do want to go back. The "what" could describe what we
heard and actually the promise could be the conclusion. You know, we\'ve
addressed some topics and, Carol, you just said you believe there\'s a
potential. You\'ve reiterated it in speeches. You know, maybe that\'s
it. You know, we believe there\'s a potential. We believe there\'s a
promise. We\'ve listed some of the roadblocks, some of the issues that
we think have to be resolved or dealt with and, hopefully, you\'ve
brought most of those to the table or that they\'re covered in some
areas so that we\'ve covered a lot of those.

But, if not, maybe that\'s the wrap up piece, that\'s the end piece.
It\'s a note to end on that putting it there may actually bring it as a
highlight rather than put in the middle of something. So, just as a
thought. I\'m just looking for a solution.

MS. DILLEY: Duane and then Dick.

MS. FOREMAN: I actually think that doing it as a conclusion might in
fact work pretty well. My concern is that we now have 28 issues and I
think maybe three, maybe four of them raise the concerns that I have
about things that might undermine that promise and the others can too.

Do you need an educational program to tell consumers how wonderful this
all this so that in the process of expanding this list we have, to my
way of thinking, gone way off on the side of all the wonderful benefits
rather than these are cautions and concerns.

MS. DILLEY: Let\'s call them topics for discussion and not a concerns
part. I mean, I think we are trying to frame \-- the question in my mind
and I know, Duane, you had your card up and then Dick. I don\'t think
anybody\'s disagreeing with having that discussion. I\'m just trying to
figure out a work plan that accommodates both having that discussion as
well as making progress on formatting, what is still a tall order in
terms of getting work done between now and January, two plenary
sessions.

So, in terms of trying to figure out how to do that and finish up the
report you need to have some specific stuff to do that. Duane and Dick.

MS. FOREMAN: One more thing. I think if we\'re talking about a two
paragraph description of promise that we probably agree on something
similar to that statement that we got together on about the consumer
issues and labeling and traceability. I think if we get past that that
we\'ll have a hard time.

MR. GRANT: Yeah. And we might be able to get it down to two paragraphs.
You know, definitely it doesn\'t need to be four pages, Carol. I fully
agree with that. And I think \-- I don\'t think I know I would agree
with your statement earlier that the pitfalls need to be listed as far
as \-- and I have no objection to listing the pitfalls. What I think
they need to be listed in is in the context of what their pitfalls as we
move towards. In other words, if you just list them as pitfalls without
having a description of what we\'re trying to move towards then they
really have no context and, so, I guess my objective in having the
promise section in there is to set the context.

And this is the context in which we had these discussions in because
that really is \-- that is, I think, an accurate representation of the
conversation that we\'ve had for the last two years is what are all of
the pitfalls as we try to move towards what all of us as see as the
promise.

So, I think I\'m just trying to capture the discussions that we\'ve had
and say this is where we think that we want to go. This is what the
promise is. These are all the pitfalls and these are the topics. Whether
we do that after we have the topics or before, in my mind it makes a
little more sense to set the context and then list the discussion of the
topics, but, I don\'t know.

MS. DILLEY: So, then outline the report just the way you\'re laying it
out is kind of preliminaries, we are, et cetera; the current products
and future products, the promise, the pitfalls attendant to whether or
not those products will be conveyed in the list of topics for
discussion. I\'m trying to understand.

MR. GRANT: And I don\'t \--

MS. DILLEY: I think you need an outline format.

MR. GRANT: Yeah, I definitely wouldn\'t call the section with the
comments the pitfalls. So, it would be the topics and there will be both
sides, I mean, in the topics. There definitely would be a description of
the issues that could hinder achieving the promise.

MS. DILLEY: We\'re using the topics for discussion section to do that.
That\'s what I\'m trying to understand is are they different? Dick?

MR. GRANT: If we don\'t do it, then I\'ll give it a try. If we don\'t do
that, the reason we\'ve got 28 topics on there right now is because
we\'re all trying to illustrate what the promise is by describing the
topics. I challenge you to go back and look at why did the issue of
needing to identify the benefits come up? All right. Because we\'re
trying to illustrate what the promise is. And that\'s why that list of
topics got so long is because we\'re all sitting around the table trying
to illustrate what the promise is and on the other side we\'re trying to
illustrate what the pitfalls are to achieving each one of those promised
items.

And I think we just kind of back away from that, acknowledge what the
promise is we\'re trying to push towards, and then have the discussion
of the relevant topics, the list of topics will shrink and become more
focused and we\'ll end up with a document that I think will make more
sense in the end.

DR. CROWDER: I was going to \-- I think we ought to be flexible in terms
of how we finally piece this together, but, I was going to make a point
that Duane made in terms of where this would fit. If I were doing my own
outline of it, but, the promise, whatever that is, before the topics and
say, okay, we went through this; this is what we see as a promise; and
these are the topics we discussed in relation to this and that the
Secretary should consider as he develops policies and so forth; and then
it lists those and then you come to a conclusion, whatever it is, that
wraps up a little bit.

So, to me, I think it fits a little bit better then rather as a
conclusion. But, I think we\'ve all got to look at what it is in terms
of how it fits together before we decide about it exactly.

MS. FOREMAN: Say that again, please.

DR. CROWDER: What I said?

MS. FOREMAN: Yes.

DR. CROWDER: Is I would start with the objective, the construction of
the committee, the objectives of the committee, the process and
procedures we use, the context, if you will, or, what we used to call in
a number of places, the environment or whatever it is, the context, and
then that would end with some paragraph or two, as you said, on the
future and then say in looking at these objectives, this context, this
environment, and this future these are topics that the committee
discussed and think that the Secretary consider moving forward and then
list those and then wrap it at the end with whatever the final good-bye
is. I mean, I don\'t know what that is.

MS. DILLEY: Brad, did you have \--

MR. SHURDUT: Yeah, and I think it was well articulated by Dick and Duane
but I support their views completely. If you don\'t go forward and look
at the promise or the future of the technology that provides the road
map and the context for ultimately talking about the topics for
consideration.

Without that, all you\'d have is a brainstorming, dump, download,
whatever you want to call it, on every issue under the sun and it
doesn\'t really provide content as to why you\'re actually bringing
those up as important issues to consider.

We all look at, whether it be markets or anything else, it\'s freedom to
operate so we can get to the next level. And it\'s to realize the
promise in the future. So, I think we need to recognize that and I think
the way it was laid out by these guys is a framework that I fully
support.

MS. DILLEY: Any other comments on format? Michael?

DR. SCHECHTMAN: Just one clarification. I wasn\'t \-- I heard that there
were going to be a couple of paragraphs on promise and that sounds fine.
I was trying to check on whatever happened to the "crystal ball-ing" on
the kinds of products that were going to be in the next five to ten
years. Was that dropped? Was that a table?

MR. SHURDUT: Was that part of the promises?

DR. SCHECHTMAN: There are two separate sections here so I was trying to
\--

DR. CROWDER: I did not intend to drop it. It was an oversight on my part
how it fits, it would fit in the context or after the promise or it
would fit somewhere in there. I think you wind up this with the \-- at
least if I were doing it on my own \-- it would wind up with these
topics that we have discussed. I think they\'re important to say these
are the areas you ought to be focusing on with some summary paragraph.

I did not intend to drop it purposely, Michael, exactly where it fits,
but, it would fit before the topics.

DR. LAYTON: And what I said it fit in the what because they were things
that were presented to us so they were \-- it was a review of things
that we saw. I think everything in here was presented to us so as part
of our process we reviewed new topics and you could list those there,
so, in my scenario it fits in a review of what we did, so, it is context
and sets up as context of how we worked.

MS. DILLEY: Jerry?

MR. SLOCUM: It seems to me just a listing of the new products is
extremely sterile because the new products are the promise, or, really
the new products are the opportunities that biotechnology affords us.
And there are some very real challenges to seeing those opportunities
come to reality and I think Carol Tucker Foreman, you know, knows those
challenges better than the rest of us. She could certainly describe them
to us better than any of us could do.

And I think it\'s a disservice to ourselves and to the Secretary to go
forward and say this is the promise and there are no challenges. You
have that discussion in the same context. These are the promises, but,
these are the challenges that must be accomplished. And I think if we
approach it in that spirit and recognize there\'s both opportunities and
challenges, both challenge and opportunity, then I think we might write
something that people find of use.

And we may get to a point, guys, that the challenges are so great that
that opportunity can\'t be recognized, okay, and we may decide that
there are opportunities that we can reach that if we can just overcome
these challenges.

I just think that it\'s important for us to be able to get to the point
that we can have that discussion that\'s not so polarized and it\'s not
so, I\'ll use the word, I\'m guilty, I\'m selfish, that we can\'t go
forward because, Michael, you encouraged us, you know, in the way we
finish our work in 2005 to get to a point where we can write about the
things that we discussed that we can\'t come to agreement on and I
paraphrase.

And I think this challenge and opportunities or this challenges and
promises, all the obstacles and promise section, whatever you want to
call it, I think that\'s the place we can do that and I don\'t see why
we can\'t do that.

MS. DILLEY: Daryl?

DR. BUSS: I like Jerry\'s comments and maybe a different way to think of
this, I think perhaps sometimes the terminology\'s inhibiting us. We\'re
focused on promise and some of these things even though we\'re talking
about as integrated topics. I like opportunities as it was a polarizing
sort of way to think about it.

And, maybe we ought to think about as an integrated section that we
might call realizing the opportunities that would let us raise the
opportunities in terms of new products and potential, but, also let us
raise if there are issues that jeopardize those, that allows us to pull
it together and that would then feed in, to me, into a topic section
that says in order to realize those opportunities more fully here are
some topics for the agency to think about.

MS. DILLEY: Duane?

MR. GRANT: I don\'t know if I would fully agree with that, Daryl,
although I definitely see the wisdom in it. I guess what I see
potentially happening in that kind of a scenario though is you end up
with a pro and con. You start to lay out, you know, the opportunity and
the challenge, the opportunity and challenge pro and con.

I\'d like to avoid that if we can. I\'d like to \-- let\'s take a look
and describe what we think the opportunities are and I have no problem
using opportunities. That is a more neutral word than promise. But, then
let\'s have a frank discussion of the challenges, but, not necessarily
in a tit for tat kind of manner.

MS. DILLEY: So, I think, I mean, first of all, the music is starting
which is about our indication. I think we have a general sense. It may
be partly semantics. I think we got a feel for what people are looking
for, what we need to do, as we\'ve got a game plan to actually get word
to paper and do the work necessary to have a draft in front of people,
have some of the conversations in October, but, some work done prior to
that and we need to think through that.

So, what I would suggest is maybe we come back. We break for lunch now
and then come back at \-- what were we proposing to do? 2:15 and try and
wrap that up in terms of what can be done between now and October and
the sense of the October agenda.

Because some of these things I don\'t think can be done in work groups.
Some of it does require group discussions. So, it\'s preparing for that,
what do we allocate to the agenda for that, and what can be done between
now and October to help advance the work I think is what we need to
really concentrate on. So, spend some time doing that and then talk
about future topics.

At that point Bernice should be here. And then we\'ll get through no
later than 3:30, 4:00.

Michael, did you want to say something?

DR. SCHECHTMAN: I guess I still wasn\'t entirely clear about whether the
\-- what specifically happened to opportunities versus predictions on
new products. I wasn\'t sure that there was agreement that they were
exactly the same. I wasn\'t sure that the idea of a description of
opportunities and challenges eliminated \--

MS. DILLEY: Let me take a stab at it. I think it was opportunities that
had both a description of some of the products because those do
illustrate some of the opportunities and then some discussion of
challenges as well within that context. Some of that will end up being
put into the topics for discussion. Some of it may be appropriate in
terms of kind of a balance to some of those things.

I don\'t think we\'re going to know exactly what that looks like until
we actually start talking about it and getting some stuff on paper, but,
there\'s just like three sections to me right now. There\'s the
preliminaries of what we did, et cetera, the opportunities, and that
includes the assessment of future products as well as opportunity and
challenges, kind of a mush of things, and then the topics for discussion
is the last piece, and then any ending statement that we \-- what did
you call it, Dick, good-bye for now or whatever.

Okay. But, anyway, Duane, am I missing anything?

MR. GRANT: So, the only thing I would clarify, Abby, and, again, this is
just my concept so it may not \-- I\'m not trying to reflect what I
think the group said, but, my concept would be that we wouldn\'t
incorporate the challenges within the opportunities section, all right.

The opportunities simply sets the context and then the challenges are
clearly incorporated in the topics for discussion.

DR. SCHECHTMAN: No, no, I think that wasn\'t \--

MS. DILLEY: I think that\'s what \-- I don\'t think we can up front make
a decision about that. I just \-- because I think we\'re maybe talking
past each other as to what that looks like and how to capture a sense of
that. I think we need to have a conversation.

MR. GRANT: Okay. We can have a conversation. So, what I heard you read
back to me wasn\'t what I tried to put on the table so I just want to be
clear on that.

MR. OLSON: I think you probably need to put some reference in that
opening, the second section, whatever you want to call it, because then
you can address the challenges. I mean, we know we\'ve got consumer
acceptance issues, we have technical issues, we have, you know, you can
kind of hit on the core issues. If we put all the challenges in the
individual topics then we get back to the dialogue, this is good, this
is bad on each individual item.

So, I think we can summarize the opportunities and new products quite
well and we can then make whether it\'s woven together. Sometimes it\'s
nice just to have a separate paragraph there to say these are the core
challenges that we have to conquer, or, face, or, wrestle with, or,
whatever the right term is. You know, generically, make sure they\'re on
the table and that they\'re there.

We don\'t have to get into exact detail about what numbers or what sense
or what area of the country or stuff like that, but, I think generically
you can put up what the challenges are. Then in the topics you might be
able to \-- if there\'s a need to highlight an issue then you can do it
there, but, it seems like we ought to \-- we know consumer acceptance,
technical issues. There are four or five really core challenges that
have to be met, plus or minus, going forward.

So, then you can just kind of put them there without getting
topic-specific on them.

MR. SHURDUT: Well, you know, because my reaction\'s sort of a hybrid
reaction here. I agree with Duane and also Ron to some extent. To me,
the topics, the way they were flushed out, do articulate the concerns
and the issues so why be redundant by including it in both pieces. If
it\'s woven together seamless you talk about the promise and then you
actually have a whole section on your concerns which are sensitive to
topics of interest.

So, again, I don\'t see why \-- I\'m not sure why we\'re sticking up
where it goes and why you need to integrate it in one section since
it\'s going to be on the back end of the promise section. That was, I
thought, the purpose of the topics for discussion, there was challenges
more or less down the road.

MS. DILLEY: I think, Carol, if you have another comment. I mean, I do
agree with Brad about the point where we just need to put some things
down on paper, have some discussion, and then figure out how to meld
this all together. So, Carol, I don\'t know if you want to add anything
very briefly and we\'ll break for lunch.

MS. FOREMAN: No.

(Whereupon, a luncheon recess was taken at 1:05 p.m.)

[A F T E R N O O N S E S S I O N]{.underline} 2:15 p.m.

DR. LAYTON: Can I remind everyone as you leave today, please, please
take off your name tag and deposit it at the front desk out here with
Diane because we reuse those. So, don\'t forget to do that.

DR. SCHECHTMAN: Okay. What we\'re planning to do now, again, a slight
departure in schedule. We thought we would briefly talk about the new
topics since Bernice has managed to come back for a little while. We
wanted to just provide an opportunity for a very brief discussion of
those.

We have two new topics that have been sent to the committee by the
Secretary and an indication of a third topic, a general area that will
be coming. What we really want to do is not talk about how to do work on
them, but, simply try just to clarify what the topics are, certainly for
the two that have been flushed out. The third one, obviously, is pretty
unclear at this point anyway. We could listen to thoughts on that, but,
let\'s begin with comments, requests for clarification on the first
topics.

MS. SULTON: Greg.

MR. JAFFE: I guess I would like a little more explanation of what is the
second topic so I can understand it. I don\'t have a real good feel for
what is the issue there.

DR. SLUTSKY: Well, clearly, and coexistence itself has been an issue
that has been raised in the international arena and to a large extent it
has been raised particularly in the European Union, but, this isn\'t
focused on the European Union. This is a topic on co-existence of
biotech crops and non-biotech crops.

And that isn\'t necessarily the focus of this topic, but, the issue of
coexistence also exists as we start having the technology to produce a
different variety of characteristics in crops, some of which will need
to be kept separate because of value added to them; some of which will
be kept separate because they\'re not intended for food use.

And, so, there are a variety of, you know, sub-issues in the topic. And
I guess a question, not necessarily on this topic, asking for specific
recommendations to the Department, although to the extent that you all
can agree on recommendations we aren\'t saying don\'t give us
recommendations, but, we certainly want to know \-- we want to gather
information on, in a sense, a state of play and how the overall of
coexistence be handled; how the impacts on different sectors of
agriculture at large, including, you know, local communities.

We\'ve seen a number of laws, for example, that have been \-- I don\'t
know how many have been passed, but, clearly it\'s a topic at the local
level. It\'s clearly something that affects our international markets
and, so, in a way it\'s a topic that\'s sort of akin to what we asked
you on traceability and labeling. You know, what is the state of play,
so to speak.

And I know that there\'s been a great deal of interest, for example, on
pharmaceutical producing crops and industrial compound for decent crops.
I always forget the acronym for those two, but, I know there is an
acronym. But, I would also include, you know, value-added traits put
into food crops.

MR. JAFFE: I mean, I also think coexistence is the really good issue. I
guess what I\'m concerned about is limiting it. It seems to me we should
do the whole range of coexistence issues, including coexistence issues
with commodity crops. And I guess I\'m concerned, especially when I read
this one. It says, what are the effects of co-existence? There aren\'t
any special \-- that I\'m aware of, there aren\'t any quality enhanced
products out there currently to have coexistence issues with.

And there aren\'t any pharmaceutical crops really out there being grown
in the commercial stage to have co-existence issues with. So, when this
says, what are the effects of coexistence, that sounds to me to be a
present tense kind of discussion, but, those products don\'t seem to me
to be out there.

They may be out there in five years from now and, so, we could
hypothesize on what could be the effects, although I think to do that I
think to some extent the best way to look is to look at organic and look
at some of the coexistence issues now and then sort of be able to map
how those might play out.

So, I guess what I was \-- so I think coexistence is a good issue. I\'m
concerned. I wanted to get a little more feel for how broad one can look
at that because I think if it\'s done very narrowly on things that
don\'t exist yet in the market I think I\'m not sure what we can add and
what will be there. I think if it\'s a broader look what\'s happened and
what will happen then I think it does make sense.

DR. SLUTSKY: Well, clearly, to the extent that \-- and I agree with you
that much of this is forward-looking and maybe we should have used a
more forward-looking tense than the present tense. And which is why we
have this committee so we can look to the future and to the extent that
you can use coexistence issues today, that exists today, as a backdrop
for thinking about what these different types of crops will present in
terms of co-existence, I think that would be fine and I think it would
be helpful.

So, in that sense you don\'t have to limit yourself.

MR. JAFFE: Thanks.

MS. SULTON: Any other questions or comments on the new topics that
we\'ll be looking at after we finish the report? Carol?

MS. FOREMAN: Thank you. I don\'t think we have anybody on the committee
who is an expert in rural development. We have a couple of economists,
but, not people who specialized in it. I only question whether we\'re an
appropriate group to look at impact on rural communities.

DR. SLUTSKY: I think that might be a valid point, you know, to the
extent that you don\'t think that you have the expertise to do that and
if we can \-- you know \-- if you think it would be of value we can, you
know, see if we can bring expertise in, or, if you don\'t believe that
you have the expertise to do it then you can \-- you do not need to
address that aspect of it as a body.

MS. FOREMAN: Thank you.

MS. SULTON: Michael?

DR. SCHECHTMAN: I just wanted to, not to disagree with the fact that we
don\'t have economists on the committee, but, certainly I think that
there are some people on the committee who come from rural communities
who may actually want to apply a little bit of their own experience.
Obviously that\'s not going to go as far as having an economist who can
really analyze it, but, I suspect there would be some people on the
committee who at least might want to talk to that to some extent.

MS. SULTON: Dick?

DR. CROWDER: I\'d like to go back to the co-existence topic just for a
minute in terms of clarification. Is this \-- I\'m going back to asking
Greg\'s question maybe in a different way. Is this anticipatory in terms
of policy issues that you expect to have to deal with? Or, is it driven
by some policy issues that you think may not be being addressed
currently? Because so far the marketplace and private contractors and so
forth have done a pretty decent job in the U.S. of addressing this.

In Europe it\'s been more of an issue because by the way they treat
biotech crops and conventional and organic and I think it makes some
difference, at least some difference in terms of whether it\'s
anticipatory or whether there\'s something out there. I think maybe when
you were not here I mentioned that in Spain for the past eight, nine
years coexistence between biotech and conventional has existed quite
well and last week there was a whole host of regulations from the
federal right down to the local level that came through and I hope
we\'re not trying to sole a problem that may not exist that\'s being
taken care of.

And I also agree with Greg that coexistence is more than just biotech in
terms of the way people farm it. Just a little bit in terms of your
perspective.

DR. SLUTSKY: I actually think that\'s a really good point and I think
this is more anticipatory than them thinking we have a problem in the
here and now necessarily. But, to the extent that as a committee you can
identify what is working now and that what, you know, what could be, you
know, and use that as kind of a basis for looking to the future, what
the problems are now, and to look to the future.

I think our feeling is as a Department is that this is something that
would \-- that we will have to face and in some instances maybe a little
sooner than we think. But, it certainly is something that\'s on our
horizon.

MS. SULTON: Yes, Duane?

MR. GRANT: Hi, Bernice. I wonder on both of these if you could give us
some guidance as to the level of feedback that you\'d be looking for
from the committee. And I guess specifically are you looking for simply
our observations or perhaps even if we\'re looking into the future,
speculative observations, if you could call them that, or, are you
looking for suggestions based on our observations? I\'ll leave it at
that.

DR. SLUTSKY: Well, I think on the first topic to the extent that you
feel that you can make recommendations or suggestions to the Department
I think that that would be helpful to us. And on the second topic, I
mean, primarily I think we\'re looking for your observations from your
perspective, but, again, if there are areas where you feel as a
committee you can make some suggestions to the Department I think
that\'s just value added, not to use the term, but, it\'s value added to
the report and would be extremely helpful to us.

Your observations in and of themselves will be helpful too.

DR. LAYTON: Do you have a time frame and a type of response to these
that you have in mind?

DR. SCHECHTMAN: Only in the most general sense. We think it would be
great if these two could be completed next year. I mean, that\'s a very,
very rough \-- you know \-- we think that these \-- we hope that these
are enough better defined that they\'re not going to be really long
reports or that they will in the process be turned from long reports
into short reports.

But, you know, we thought that \-- we\'re hoping that these were
straightforward and clear topics, but, as with everything, time will
tell.

MS. SULTON: Greg?

MR. JAFFE: Yes. I had a question on the first one. It says there that it
sort of seems to be limited only to economic impact and we know that
biotech products have, you know, both environmental benefits, have
health benefits. I\'m thinking especially when you get to developing
nations and so forth.

I\'m wondering, do you really mean to only limit this to positive
economic impacts or are we free to discuss other kinds of beneficial
biotech small \-- I mean, non-major crop things that have other benefits
to society, either domestically or developing countries but that aren\'t
necessarily quantified as positive economics?

DR. SLUTSKY: You do not need to limit yourself to only economic impacts.
I think we were thinking of that sort of at large.

MS. SULTON: Anything further while we have Bernice here? Thank you so
much Bernice.

Michael, shall we go on to the work plan discussion now?

DR. SCHECHTMAN: Yeah. I think just perhaps for just a second or two,
obviously we haven\'t told you, because it hasn\'t yet been figured out,
what exactly what project will be sent to USDA on the animals topic,
but, this was just intended as a place holder, if you will, to let folks
know that it\'s on USDA\'s radar screen. The topic in general is on
USDA\'s radar screen. And we\'ll be thinking about how \-- you know \--
what the needs are in terms of additional information, expertise,
representation on the committee might be necessary to address those
issues.

So, I just wanted to put that out there and see if there were any
particular comments on that.

MS. SULTON: Carol?

MS. FOREMAN: Do you know the timing on it at all? The committee \-- my
appointment, for example, expires next year.

DR. SCHECHTMAN: Your first appointment. I mean our intent was that when
these two projects are completed that that would probably be the next
thing that the committee would tackle and we were hoping that these two
would be finished next year.

MS. FOREMAN: The whole year?

DR. SCHECHTMAN: I\'d be very prepared to be happily surprised and see
the projects get done sooner.

MS. SULTON: Okay. Anything \-- oh, Dick, sorry.

DR. CROWDER: Just one quick process question that could probably wait
but curiosity is important sometimes. The two that have been identified,
is it your expectation that we would work on these and parallel our work
on them in sequence and that if we work on them in sequence what\'s the
\-- which one has priority over the other?

MS. SULTON: We haven\'t talked about whether \-- and I\'ll leave it to
those \-- you know \-- when you talk about your work plan, but, if you
determine that you cannot work on them in parallel I think that what we
would like to see is you work on the coexistence topic first and then
minor crop second.

But, to be honest, they\'re almost of equal importance to us so that\'s
an almost arbitrary decision on my part.

DR. SCHECHTMAN: I think we\'ll at least discuss among ourselves whether
it will be possible to have work go on simultaneously with them and, you
know, there will be some discussion on that before we get going on it.

MS. SULTON: Anything further? Thank you again. What comes next, if we
can turn to what\'s on our table now, we had a proposal about how we
might proceed that we think is consistent with what we were discussing
before lunch.

As regards to the new issues piece, we expect that we\'ll probably have
to convene a couple of telephone work groups in September and we\'ll be
reaching out to you all for schedules very soon after this meeting. As
regards to the old issues that we now have to write in three minute \--

DR. SCHECHTMAN: Topics.

MS. SULTON: \-- topics, the old topics that we\'re going to write in
three minute fashion as opposed to three, 30 minutes, we\'re thinking
that we\'ll put together a Chair\'s draft in consultation probably and
there will probably be consultation with individuals as that\'s being
put together.

After that Chair\'s draft is written it will be disseminated for
comments via electronically and then we\'re thinking after you\'ve had a
chance to look at that Chair\'s draft then we can convene a third work
group to work on the opportunities and challenges piece thinking that it
would be a little easier to write that one after you have a better sense
of how we\'re writing out the issues.

That we think will give us a very full time between now and the October
24th-25th. Michael?

DR. SCHECHTMAN: Let me just add a little bit to that. In thinking about
this the thought was, for the existing issues we\'ve heard lots of the
discussion and we\'ve also heard some comments from people that it would
be really very difficult to get all of the \-- get all of the writing
done in work groups on those things. We can consult with a number of the
members in the drafting of a last version to be shot at, if you will,
for the issues.

But, if we have, you know, one set of people trying to produce at least
a consistent format for the existing issues that might expedite the
process a little bit. Where we have a little less sense that we know
exactly what the new topics are about and we thought that it might make
sense to be sure that we had specifically each of the proponents of the
folks who raised the new topics involved in work groups, helping to
flush out what they are, and that we can put those two pieces together
in the topics for discussion piece that you\'ll have a chance to respond
to before the next meeting.

Also, if we can go back to the discussion on what the first piece of the
report is going to look like. We\'re probably going to need to do some
portion as a Chair\'s draft as well for the \-- certainly how the report
was developed which is sort of the easier, who we are and how the report
was developed, is the easier part perhaps.

In terms of the promise, the opportunities and realizing the
opportunities and challenges, whatever that is, I can\'t recall if we
were going to come up with something.

MS. SULTON: We said we were going to do a workup on that.

MS. DILLEY: We said first cut or at least a bullet for that group to at
least start taking a run at it. But, we need a group to work on that.
The whole goal is to have another \-- a full draft of the document at
our October meeting and we\'re trying to do that in pieces, having two
discussion groups on the new topics which require a little bit more, I
think, to distill out and it can remain two or four sentences, whatever
it\'s going to be, take a run.

We take a run at the other topics that we\'ve gone through over the
course of this meeting and put that back out for preliminary reaction
before we get in the room together in October and then we also take a
first cut at compiling some elements of what the introductory parts look
like and then have a group actually get on a call and walk through a
question and outline.

DR. SCHECHTMAN: I think the one thing that I would just emphasize that
in the work of preparing the Chair\'s text on the existing issues, we
may be working on the drafting here, but, that\'s going to be a
consultative process with the folks whose issues they are to try to \--
and with others to try to see how much we can address concern along the
way.

MS. SULTON: Dick?

DR. CROWDER: I think I\'ve heard two things and I want to make sure I\'m
right and make a comment. When Cindy was commenting what I heard was
this is going to be a Chair\'s draft of the topics and there would be a
working group \-- Chair\'s draft, working group on new topics, the
Chair\'s draft, all the topics, and then after we got that we would work
on the opportunities and challenges and so forth.

But, that\'s not what I heard from Abby and Michael and I think if I
know from Abby and Michael what I heard I liked that better. I don\'t
think we have enough time to do those in sequence. I think they need to
be done more in parallel and two other observations on that just in
terms of the flow of the product, flow of the work product, the paper,
the challenges and opportunities were going to lead into what the
discussion topics were.

And the second point is, is much of that work has been done and just
needs consolidating. So, I would encourage us if administratively
possible, \-- I know there\'s a lot being put on your office and I
recognize that and respect it although I don\'t fully understand it
because you\'ve got other stuff to do and I don\'t know nothing about
\-- but, I think it would be better if those things were in parallel
rather than in sequence, not only because of the flow of the report,
but, because of what we\'ve got and timing also.

MS. DILLEY: It\'s meant to be in parallel and the limiting factor is
who\'s on those groups and how quickly we can pull them together.

DR. CROWDER: Okay.

MS. SULTON: Any further reactions to the process we\'re proposing? It is
a lot we\'ll be doing between now and October. Pat?

DR. LAYTON: I guess I\'d like to think about time line. If we had a
draft by October 1st \-- I know that\'s a lot, but, that\'s actually six
weeks.

(Discussion off the record)

DR. LAYTON: Or maybe the first week of October it would allow people to
actually read it and even have maybe a first set of comments back in
writing to go before the 24th and 25th. Because I know, Dick, you can\'t
be here, right? No decision on comments, but, constructive, you know, if
there\'s a line and you don\'t like it you have to say what you\'d
replace it with.

And even if it\'s just a matter of cutting and pasting, all those
different versions of it together, I think that it would allow us to
move through the 24th and 25th more rapidly. And not that we would ever
get to final there, I\'m not sure we would, but, at least we have a lot
more in place to work with.

And, so, I guess the question is, how long before the 24th and 25th
would you need to see a document in order to get something back? I mean,
would a week before that? Are you going to be somewhere out of the
country? I know the week before that I\'m the limiting factor on
meetings so it sounded like some of your calendars were clear.

MS. DILLEY: The reaction that Pat \-- so you\'re looking for a draft
when we all sit down on October 24th and 25th we have a draft that has
the original language and a compilation of the comments incorporated
into it. So we need a bit of time.

DR. LAYTON: Not incorporated into it. I literally in a style we talked
about before, side by side. So, it\'s cut and paste. So, there\'s no
decision made. It\'s just here\'s what we said, here\'s the comments we
got on this, here\'s what was said, here\'s the comments we got. And
it\'s just a good working document to work from.

MS. SULTON: Greg, do you want to comment on that?

MR. JAFFE: I can comment on that. I also have some general possibilities
for process. I mean, my comment on that is I just want to make sure that
whatever we \-- if we get things with enough time in advance of the 24th
or 25th to look at them I don\'t want to get a document the day before
or the Friday before with comments or without comments or a second
draft.

So, I think we need to have, you know, get a document a week or at least
four business days or something before the meeting for whatever we\'re
doing preparing for the meeting so you could then work backwards, but, I
think that\'s fairness dictates that or something like that.

Two other suggestions though and one is, I\'m not sure why we have to
wait until all the topics have been drafted to circulate a draft,
especially if they\'re old topics and new topics and things like that.
It seems to me this could be done serially. I mean, I don\'t want every
single one that\'s come out. But, as a number of them were done I don\'t
see why we couldn\'t do some rolling thing here instead of waiting for
25 of them to come out. So, that\'s one thing.

The second thing, and, again, I\'m just drawing from my experience on
the issues work group for the past two years is, is format has become a
issue in how you\'re going to title these and how they\'re going to
look.

And one option would be to put together a few, two or three of them as
straw men before the Chair spends a lot of time in a particular format
and people have some concerns with that format and so forth. We haven\'t
really talked today about the format of the three or four questions.

MS. SULTON: Actually, that was while you were out of the work room.

MR. JAFFE: Oh, okay. Well, but, I just \--

MS. DILLEY: I don\'t think you were here but we had an additional
discussion of putting a couple out in advance.

MR. JAFFE: Just sort of see it that that format works for people before
\-- because in the past what we\'ve done is written them one way and
then we go back and there were questions and we put them into statements
and we put them into innocuous statements and so forth. We constantly
spent a lot of time actually changing format. Getting that down
initially might save us later on.

MS. SULTON: We can try to do that, Michael?

DR. SCHECHTMAN: We can certainly try to do that.

MS. SULTON: What would really help is when we send out these
availability questionnaires to get them back really fast so we can
schedule those first work groups because we\'re looking ideally to do
that the first week in \-- beginning of the first week in September,
right after Labor Day, in order to get started. We have to write
something before then. From what my knowledge of people\'s availability
was in August. That was the other reason.

MS. DILLEY: I mean, I think the other thing, unless you want us to
propose \-- we basically talked about three conference calls, two of
which are on new topics and one of which is on the not topics for
discussion, but, the other portion of the report. It would be helpful, I
think, to, one, we wanted diversity of perspectives on each of those
calls, but, we also want to be as accommodating as we can in terms of if
there are particular discussions that you want to be a part of. It\'s
hard to know that in the absence of just putting out the eight or nine
issues and sorting through them.

So, we could either take a run at that immediately after the meeting or
at least get a sense of people who had a burning desire to be on the new
topics discussion or the other discussion that might be helpful at least
to get us a sense of allocation of effort.

DR. SCHECHTMAN: Let me just also make the suggestion that even if we do
ask particular people if they\'d be willing to work on a particular set
of issues each of those calls would be open-ended so if someone else
wants to join into the discussion they\'d be welcome to do so.

MS. DILLEY: Yeah.

DR. LAYTON: Did we consider actually assigning the new topics to like
two people to submit a first draft on?

MS. DILLEY: We can consider anything.

MS. SULTON: I guess part of the thought, since we\'re not writing the 30
minute piece, we\'re writing very succinct pieces, that we could get
that formatting and style thing down and then have everybody react to it
whereas if we had individuals write it they would come back in different
styles and format.

DR. SCHECHTMAN: Yeah, I think we can try here to get two of what we will
naively assume to be some of the easier issues we\'ll pick out and
we\'ll try to draft up a version of those and have you see how you like
them in terms of style as opposed to content.

And, if people are okay with the way they look that may help the process
in working on the new ones.

MS. DILLEY: Trial.

DR. SCHECHTMAN: Yeah, trial balloons.

MS. SULTON: Any other reactions or suggestions to help us with this
process? People have a sense whether they will be available in September
for work group? Early September. Carole?

DR. CRAMER: It sounds like you guys have thought a bit about what would
be an appropriate work group and focus. Why don\'t you guys just throw
it on the table? I want to go, let\'s \--

DR. SCHECHTMAN: No, our lunch wasn\'t that long.

DR. CRAMER: Oh, okay. So, I think we should move as quickly as possible
to figure out how we\'re focusing these groups.

MS. SULTON: Greg, you have a suggestion on that?

MR. JAFFE: Are these work group? I thought they were just a couple of
individual conference calls to sort of work through the select things.
In our past history we\'ve had work groups. They\'ve been a long-term
group with a specific charge and worked as a group to do a specific task
over a number of conference calls and things like that.

What I just heard was more like we\'re going to have three individual
conference calls on three separate topics and we\'ll pick some people to
be on them but they\'re not \-- anybody else could be on them, but,
they\'re not a work group. I don\'t \-- maybe I\'m \--

MS. SULTON: In the words of Ed McMahon, you are right, sir. Three calls.

MS. DILLEY: Yes. I mean, the bottom line is yes, there are three
conference calls. We just want to make sure that there is a critical
mass of people actually show up on these calls and are responsible for
taking the lead in developing them. So, you don\'t have to call them
work groups. They\'re not established work groups with a particular
charge other than to bring text, to have a conversation enough to spill
out text for those topics that were identified, nearly identified
topics, and then also on the other introductory section.

DR. SCHECHTMAN: I think it\'s also maybe building on something that you
were saying, I think. We might in the preparation leading up to those
work groups identify who the proponents were of the individual issues
and maybe go to them to get, you know, some of their ideas down, maybe
not in the form of the issue, but, at least so we\'ll have a little
background going into each of those calls to the extent that it\'s not
clear from the meeting notes, from this meeting.

Carol?

MS. FOREMAN: As I understand that on the introductory remarks, benefits,
et cetera, we\'re going to have a set draft, a leader\'s draft and that
the word groups are going to trying to flush out the issues? I just want
to be sure I understand.

MS. SULTON: The bullet from that and then the work group to flush it
out. I mean, a work session, not a work group, but, a work session to
flush it out.

DR. SCHECHTMAN: There will be some text drafted whether it looks like
bullets or whether it looks like long tortured sentences that, you know,
we\'ll try to have a short, fairly succinct portion on that as a straw
person to be dealt with summarily.

MS. FOREMAN: And that\'s for the introductory benefit, promise,
opportunities, challenges. I think that\'s a terrific idea. On the
statements that we already have a statement of concern are we going to
have work groups rewrite those?

MS. SULTON: We\'re going to have a Chair\'s draft of that. Based on what
we heard today, we\'re going to do the three minute summary of each one
of those.

MS. FOREMAN: Good.

DR. SCHECHTMAN: And we\'ll try to consult the proponents of those things
in the process of putting those together.

MS. SULTON: Does anybody else have any comments on the process or any
advice or ideas about it? Okay. Then, Pat \--

MS. FOREMAN: Just a personal matter.

(Discussion off the record)

DR. HUNT: Michael, if I understood you correctly for the topics which
aren\'t new you\'re still going to approach those people who were the
original proponents of them. So, how do the new members get involved if
they want to?

MS. SULTON: If there\'s a particular topic you want to get involved in
you could let us know about that and we\'ll certainly reach out because
I don\'t think we\'re talking about the reach out to the people who
originally proposed it. The outreach will be broader than just an
individual.

DR. HUNT: So, in each of these discussions are going to happen the whole
group\'s going to hear about it and then those who want to partake in it
will have the option to do that?

DR. SCHECHTMAN: I don\'t think it\'s feasible at this point to think
about having 28 sessions or however many, 18 sessions on the individual
issues. We will attempt to consult with folks that we know were
specifically quite interested in particular topics. I know that the new
members haven\'t had quite the same level of opportunity to do that.

I welcome hearing from folks, particularly ones that you want to have
discussions about. There will be a new draft that will come around for
the full committee to discuss at the next meeting so there is that
backstop.

If there are particular ones that you want to be involved in before and
there will be an opportunity for everyone to see them and comment on
them via e-mail, one round, if we try to get you a draft by the
beginning of October there will be an opportunity for submitting
comments prior to the next plenary session as well.

But, if there are others that you actually want to be more actively
consulted on, again with the limitations of trying to pull all of this
together, let me know.

DR. LAYTON: I actually put up some proposed dates and they\'re just out
there. If we have the meeting the 24th and 25th to honor Michael\'s
request that whatever come out \-- whatever we\'re going to use in the
meeting \-- we are having the meeting the 24th and 25th. Not if, sorry.
Meeting, 24 and 25.

To honor Greg\'s request he would like to see whatever he has to prep
for the meeting four business days ahead of time. That really puts it
out. We could send it out the close of business Monday afternoon, the
17th. That way you\'d have it in your e-mail when you got back to work
the morning of the 18th. That gives you four business days.

Backing from that though that means that whatever draft we have to
solicit people\'s comments I wanted to give you like a couple of weeks
to give comments on an initial draft, but, then what I propose is that
when we come to the 24th and 25th the document that comes out on the
17th is basically the document we sent out on the 5th with the comments
by line.

So that what we\'re going to do on the 24th, 25th is work through that.
So, basically it\'s cut and paste comments into the draft. So, what we
have to do is have a draft of the document out so to everyone by the 5th
to give you almost two weeks to comment on, you know, by line, by
section, or, by topic, whatever, and you may construct a comment, not
note, but, suggested wording, this really should be folded into, you
know, something constructive.

Is 10/5 a date that if you had something by, that gives us the month of
August and September, early August or between now and say middle of
August, third week of August, we could come out with two or three of
these topics that we feel like you know a lot about with the format
issues down and then allows you to move into, say, the first of
September with some formats down for the newer topics to get on a
conference call and flush out the newer topics.

Meanwhile, there\'s still work going on on the rest of the document as
well as the older topics, working on those. Anybody got suggestions they
can send it in. If you\'re burning a desire on an old topic and you\'ve
seen the format and you want to send it in prior in September you could
send one in.

Our text for challenges, text for opportunities, text for whatever, you
could send it in and then that by the 5th we\'d have some kind of at
least draft of the entire thing, rough as it may be.

DR. SCHECHTMAN: I guess I think that schedule is generally good. The one
little caveat that I had there was that I thought I heard new texts
coming in unexpectedly on old topics and \--

DR. LAYTON: No, I didn\'t mean that.

DR. SCHECHTMAN: Okay. Okay.

DR. LAYTON: You know, if somebody \-- no, that\'s not what I\'m talking
about.

DR. SCHECHTMAN: Okay. Okay. Because, I mean, we\'ll incorporate all
those comments that come in, but, I don\'t want to have to think about
multiplying the number of texts as opposed to just having other things
as comments.

DR. LAYTON: The Chair\'s document would come out with text for 19 and
you said there were how many other new ones?

MS. GRANT: Nine or ten.

DR. LAYTON: Okay.

MS. GRANT: If research is a separate issue it makes it 10. If it\'s get
rolled into another what we first came out with 9.

DR. LAYTON: Okay. So then September we would have two conference calls
on those coming up with those 10. Is that what I heard? As well and then
a third conference call on kind of going through some of the intro
pieces, putting it together by the end of October for a draft that would
then come out as a complete paper draft for comment on. You get them in,
back by the 17th. We get it in a side by side manner and we have
something to work from on the 24th and 25th.

MS. SULTON: I think we should, just to be realistic, we have to \-- if
we do a work group the first week in September or two work groups the
first week in September then we will have writing to do subsequent to
that. Have another work group and we\'ll have writing to do and then
have to compile it. If that slips and we don\'t have that work group
that first week in September then that makes it even more difficult to
meet that schedule.

So, hopefully, again, we get immediate response to availability. Greg?

MR. JAFFE: I\'m going to make my suggestion one more time that I don\'t
\-- I\'m not sure why we have to wait until October 5th to get a full
draft of all of it. There are 28 issues. That is a lot to go through
even in a week and give substantive written comments back to. If 12 or
15 of those are done in the middle of September I don\'t see why since
they\'re going to be written serially, parallel, I assume, the Chair was
writing them, I\'m not sure why one can\'t send out a draft on September
20th for 15 of them and send out a draft out on October 5th with the
other 13.

I just \-- but, I think that\'s a more efficient way of doing things as
they get done, obviously not sending one out each time, but, I think one
can review these without waiting to see the whole picture October 5th.

And looking at my calendar if you got it October 5th you have a week to
send it back. It\'s a week to do it. It\'s October 12th. But, the 17th a
Monday. So, the 16th, 15th, 14th, so, you\'re really giving the Chair
only a day or two to compile all those and put them back in. It\'s not
really two weeks between the 5th and the 17th.

There\'s a week. You\'ve got to give everybody at least a week to review
so it\'s really only one or two days for the Chair to then take all
those comments from 20 different people and put them in and return the
draft around to people. So, anyway.

MS. SULTON: You have two groups and then you have the old topics. Those
might be able to get out to you serially or in advance, but, the new
ones won\'t be ready until after the work group, the work session.

Duane?

MR. GRANT: Yes. I don\'t disagree with Greg\'s comment to send them out
serially. The only thing I would suggest to the Chair who other than
good luck, but, to the Chair who would put this together is that there
are some of the new ones that are closely related to some of the old
ones and there are a few of the old ones that could probably be
consolidated and there are some of both the new and the old that will be
affected depending on what\'s placed in the promise section.

So, I would just suggest you take the ones that clearly stand on their
own merits and do those first and then look for the ones that can be
consolidated and/or will be affected closely by what\'s in the promise
\-- what was the rest of that \-- promise \-- opportunities challenges,
there we go. Get the new vernacular down. And do those as you put the
opportunities challenges section together because I think those really
will need to be reviewed conjunctively.

DR. LIPTON: And that is exactly \-- I had it has one draft because I
knew that was probably going to be the case.

MS. SULTON: Michael?

DR. SCHECHTMAN: I just want to check on one thing from what you said,
Duane. I wasn\'t thinking or I don\'t think we were thinking that the
Chair\'s draft was at this go around going to actually do those
consolidation things. Maybe there are places we can point out to the
full group that they might consider whether they wanted to consolidate,
but, I didn\'t think at this point through we would actually do those
things.

MR. GRANT: I think that\'s the appropriate way to handle it, Michael,
other than as you\'re drafting them I think you\'re going to hear some
of them that the draft \-- I mean they\'re going to just suggest to you
that they clearly could be consolidated and those, I would take the
liberty to at least place them one above the other on the pages we get.

DR. SCHECHTMAN: We\'ll break them in complete randomness in that way.

MS. SULTON: Further comments?

DR. SCHECHTMAN: Actually, just one thing first. I think it\'s clear from
this that we will need to turn around a next steps memo sort of flushing
out what it is that we understood was agreed to here and we\'ll try to
do that very quickly because there is a lot of work that\'s going to
have to happen very quickly as well.

MS. SULTON: You can expect the next steps memo and the availability
chart.

DR. LAYTON: Thank you. We have done a tremendous amount of work over the
last day and three quarters and I appreciate your help in getting
through this. It is a challenge. I think you\'ve allowed the Chair\'s
draft to take a few liberties in editing what documents that we\'ve seen
what wonderful words other people have written and try to present
something that based on what we\'ve heard today, seen today, and
yesterday will come together in a draft that will allow us to see a flow
and a working document that will follow.

Please, I encourage you when you do get your calendars to make those
dates available quickly or let us know what availability you have so
that we can schedule these conference calls to be sure we have the input
and I know it\'s a tight time schedule but even if I have to work on a
Saturday myself, personally, and do the cut and paste I think there\'s a
football game that I don\'t have that weekend, so, I\'ll stay home and
not tailgate and if I have to I\'ll do it myself, cut and paste.

But, I think it is important to try and get it done and I think if we
can we\'ll all feel better about what we have as a work product because
I also heard the frustration today and yesterday morning about, well, I
don\'t know what we\'re working on and I\'m not sure what I\'m going to
do in this session and then, you know, this agenda wasn\'t very neat,
you know, didn\'t tell me a lot and I don\'t want to have that again
because I did hear that and I think that\'s a very constructive
criticism to be sure that we have this out.

And I want to also respect the missing members like Dick who might not
be here because his comments, given that we have a draft ahead of time
he can either pass in ahead of time or get with one of you and making
sure that his comments get \-- because if we get to this point we\'re
getting very final on this document on the 24th and 25th, so much so,
you know, that depending on the 24th and 25th and then have a rewrite so
we may ready to move onto the new material in early January which would,
I think, make a lot of us very happy.

I\'m dreaming, yes, I\'m dreaming. Well, I am a cockeyed optimist in the
group, but, I urge you to \-- you know \-- if we call and ask with
questions or seek your input, you know, we didn\'t flush out this
discussion well, you know, please try to get back to us, Abby, or,
Cindy, or, myself, or, Michael when we\'re trying to find out what\'s
going on so that we can get your comments early and make sure we\'re
writing these up correctly.

I don\'t know about Abby, Cindy, and Michael, but, I have time today. My
plane\'s not until seven, so, if we could sit here and crank out one or
two of these over the next couple of hours and if you\'re here and you
don\'t have to go get a plane, you\'re welcome, I\'m sure, to stay with
me and try to crank out one. The sooner the better.

Michael\'s dying. I\'m ambitious. I have four hours. I need to fill it.
But, whatever we can do to get these things working and I do think that
format is very key so if you\'ve got any ideas on format even if you
can\'t stick around, holler and let us help quickly get the format
entered, take a shot, and draft one up that you think works and I\'m
willing to look at it.

Thank you very much.

(Whereupon, at 3:10 p.m., the meeting was concluded.)