UNITED STATES DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C.

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:

ADVISORY COMMITTEE ON :

BIOTECHNOLOGY AND 21ST CENTURY :

AGRICULTURE (AC21) :

ELEVENTH PLENARY MEETING :

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A meeting in the above-entitled matter was held on Friday, January 6,
2006, commencing at 8:30 a.m., at USDA, 1400 Independence Avenue, S.W.,
Room 107-A, Jamie Whitten Building, Washington, D.C. 20250.

Dr. Patricia Layton, Chairperson

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

Patricia Layton, Chairperson

Michael Schechtman, USDA

Abby Dilley, Resolve

Kathy Grant, Resolve

Cindy Sulton, HW&W

Bernice Slutsky

Madelyn Spirnak

Leon Corzine

Duane Grant

Kathleen Jones

Randal Giroux

Josephine Hunt

Elizabeth Milewski

Carole Cramer

Russell Kremer

Gregory Jaffe

Jerome Slocum

Michael Dykes

Vincent Vilker

Ronald Olson

Margaret Mellon

Carol Tucker Foreman

Bradley Shurdut

Alison Van Eenennaam

Lisa Zannoni

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

DR. LAYTON: Good morning. Carol Tucker Foreman was going to be a few
minutes late this morning we know.

DR. SCHECHTMAN: She said she might.

DR. LAYTON: Might be a few minutes late. But we need to get at least \--
I thought we could deal with at least 14, a confirmation of language. I
mean 18. The OSTP one. Because that was a fact check. But since that was
a fact check, I thought maybe we could do the fact check.

Published case studies in 2001. That suggests?

DR. CRAMER: That language changed and it was challenged.

DR. SCHECHTMAN: I have new language which I\'ll sit down and I\'ll read
it out.

(Discussion off the record)

DR. SCHECHTMAN: In any case, let\'s see if we can talk about this. Both
Kathleen and I went back to the OSTP case studies last night and I came
up with the following new language. You can see up there, but I will
read for those whose eyes aren\'t yet focusing.

The Office of Science and Technology Policy, OSTP, published a package
of regulatory case studies in 2001, one of which described a prospective
pathway for the regulation of transgenic fish using FDA\'s new animal
drug authorities under the Federal Food Drug and Cosmetic Act. FDA
indicated in that case study that it intended in the future to draft
guidance on how the new animal drug provisions of the FFDCA pertain to
transgenic animals and on procedures by which companies developing
transgenic animals could comply with those provisions. Then it goes on.
However, the government has issued no further guidance in this regard.
So, that just gets the facts right.

DR. VAN EENENNAAM: I guess, so, do we resolve whether it\'s animal or
the product that\'s regulated under the new animal drug? I\'m just
thinking of Mardi who is concerned that it wasn\'t the animals that they
regulate.

DR. SCHECHTMAN: Well, they\'re talking about regulating the drug, but
the case study is for regulation of transgenic fish. So, you know, the
case study is headed, you know, regulation of transgenic salmon. So, I
tried to finesse that a little bit here, you know, that the fish, you
know, pretty much the way the case study is laid out. Within it, it
talks about the drug within fish.

I was trying to finesse it because the case study is not titled, you
know, regulation of new animal drugs in transgenic.

DR. LAYTON: Well, shame on them.

MS. DILLEY: Good morning, how are you?

DR. LAYTON: Good morning, Michael. Okay. So, is everybody okay if we
take that? It is what it is. Okay. Moving on. Okay. With that, we\'re
going to move to \--

MS. DILLEY: Well, we were going to 14 which had language that we were
trying to \-- I hate to do that with Carol not here.

DR. LAYTON: Okay. So, let\'s not do that one. Can we move into 17?

DR. SCHECHTMAN: Can \--

MS. DILLEY: It\'s pretty hard to do some of these.

DR. LAYTON: Okay.

MS. DILLEY: Let me anticipate not having all committee members here.

DR. LAYTON: Can we do 23? There was one that I thought was fairly
simple.

MS. DILLEY: You mentioned 22 yesterday.

DR. LAYTON: 22 was fairly \-- there were not edits but they were
editorial, I thought.

MS. DILLEY: This is an awfully hard one to do without Carol here. But if
you want to raise concerns right now. I just hate to \-- I don\'t know.

DR. SCHECHTMAN: Can we run through some of them?

DR. LAYTON: 22 is two words?

MR. OLSON: Yeah.

DR. LAYTON: Yeah. 22 is only two words.

MS. DILLEY: It\'s more editorial in nature.

DR. LAYTON: That\'s what I\'m saying, it\'s very editorial, and I
didn\'t think Carol had a big deal about it.

MR. OLSON: I thought Carol\'s ending was pretty good.

DR. LAYTON: Yeah. Can we look at 22?

DR. SCHECHTMAN: Greg, in your absence we\'ve got some new language going
back to the case study to correct the OSTP, the sentence about OSTP
regulation of transgenic animals, both which I can \-- can you flash
that back up?

MS. SULTON: Which one?

DR. SCHECHTMAN: The one you were just working on. 18, yeah, down a line
or two.

MR. JAFFE: Are you on 18 or 22?

DR. SCHECHTMAN: I\'m just showing Greg the new language that we just put
in on OSTP while people are looking at 22.

MS. DILLEY: That was lifted off a case study.

MR. JAFFE: My concern with that is that, I mean, you\'ve taken out the
word some and not all transgenic fish because the GlowFish^®^ was not
regulated and, so, I mean, if you\'re going to put that in then you\'ve
got to put in that one animal was not regulated, GlowFish^®^, if you\'re
going to use the fish unless you put in some. I mean, or, try to put in
salmon because the reality is that they have not \-- they chose not to
regulate the GlowFish^®^.

DR. SCHECHTMAN: Fair enough. Fair enough.

DR. LAYTON: Transgenic salmon instead of the word, fish.

DR. SCHECHTMAN: Regulation of a transgenic salmon using in the first
sentence of that.

DR. LAYTON: Right at 750. Line 750.

MS. DILLEY: She doesn\'t have numbers.

DR. LAYTON: Yes, she does on top. It\'s a transgenic fish, at the very
end of that.

MS. SULTON: Now you want to make that what?

DR. SCHECHTMAN: A transgenic salmon.

MR. JAFFE: Salmon and then the next sentence you\'d want to put \--

DR. LAYTON: Wait a minute. Let her go back and put a.

DR. VAN EENENNAAM: Well, why do you want to put a in there?

DR. LAYTON: Because it wasn\'t multiple species of salmon.

DR. SCHECHTMAN: It was just a particular \-- it was a fish with a
particular modification they described the regulation of.

DR. VAN EENENNAAM: A transgenic corn plant or transgenic corn?

DR. SCHECHTMAN: They were describing the regulation of a particular \--

DR. LAYTON: One single fish is what they\'re talking about.

DR. SCHECHTMAN: It was \-- fine, yeah. The next sentence was lifted
exactly from \--

MR. JAFFE: Then put it in quotes.

DR. LAYTON: Take the a out.

MR. JAFFE: If it\'s quotes, if it\'s actually quoted, quote the part
that\'s quoted because otherwise it suggests that they\'re doing all
transgenic animals when we know that some of them they\'re not; they\'ve
clearly decided not to do it.

DR. SCHECHTMAN: Well, no, they said that they were going to publish this
guidance. They never did.

MR. JAFFE: I understand. But \--

DR. SCHECHTMAN: Okay.

MS. SULTON: So, where do you want the quote to begin?

MR. JAFFE: Find where the actual quote is and let\'s quote it.

DR. SCHECHTMAN: Start with intended until the end of the sentence.

MS. SULTON: Do I need to put some dots in there?

DR. SCHECHTMAN: Sure.

DR. JONES: It\'s actually intends.

DR. SCHECHTMAN: Intends? Okay.

DR. JONES: Intends to publish.

DR. SCHECHTMAN: Actually \-- go ahead, you have it right in front of
you. That\'s fine.

DR. LAYTON: Okay. Moving on.

MR. JAFFE: Sorry about that.

DR. LAYTON: That\'s okay. We want to be sure we\'re correct. That\'s why
we have a lawyer.

DR. SCHECHTMAN: Michael.

DR. DYKES: I hesitate to raise the question, because I don\'t
necessarily have an issue with what\'s written on 22. I guess, as I read
it, so what are we communicating? What\'s it about? What is the real
issue here? I mean, again, I read the words, but why don\'t we have a
topic in here on price of lamb, you know, why prices are going up and
that\'s problematic for some and others it does not pertain. I mean, I
just don\'t know what the relevancy here is.

I mean, if I was the Secretary and I read this, I\'d go, okay.

MS. DILLEY: Greg.

MR. JAFFE: I mean, I think part of the issue here is that there are \--
that the adoption and acceptance of genetically engineered crops and
animals in particular, but also crops is not solely a factor of safety
considerations. And the regulatory system is focused primarily, but not
exclusively on safety considerations and I think the point of this,
we\'ve had a lot of discussion, and, remember, these topics are just
supposed to be the discussions that we\'ve had about the issues that we
think will play a role in biotech over the next ten years.

And, clearly, we\'ve had lots of discussions about the fact that there
are ethical, moral, and other issues that consumers and the public are
going to have about them, but aren\'t things that are addressed by the
health and regulatory system, especially for USDA and the government
where their view is, okay, APHIS, we go and we ensure that this plant
doesn\'t harm agriculture and doesn\'t harm the environment and it
should be fine, everybody\'s going to accept it.

But I think they\'ve seen with international trade, with a host of other
things, that just because you pass the safety test does not mean that
your product will be adopted. BT potatoes or GE wheat, a lot of those
things, nobody had questions about GE wheat being safe and, yet, we
don\'t have it out there.

So, I mean, I think this, whether it\'s artfully said or not, the point
of this is is to capture the discussion we\'ve had around here that just
proving a product is safe is not enough and that there are other
considerations and I think this discusses some of those.

DR. DYKES: Other considerations accepted in the marketplace.

MR. JAFFE: That\'s right.

MS. DILLEY: Maybe that\'s what it should say in the \--

MR. JAFFE: And maybe it should say the public has concerns, but talk
about that, but I think it is trying to make that distinction between
the health and safety regulatory system and the fact that that alone is
not sufficient for acceptance.

DR. DYKES: As I listen to that, that, to me, I mean, I agree with that.
I think that\'s what experience would bear out and I think it\'s
something to communicate to the Secretary. But as I read what we have
here, I\'m not sure that\'s the conclusion one reaches immediately.

DR. LAYTON: Okay. Could you suggest a change?

MS. DILLEY: Maybe accepted. Just what Greg said.

DR. DYKES: I could, but I hesitate because I think it will be seen as
trying to shorten this and take away from it. That\'s part of the
problem you get when you get to this stage of the game, but, again, I
think this is kind of one of those things that could be mentioned in a
couple of sentences, kind of like transparency in one of the others we
did yesterday. We\'ve got transparency throughout this document.

I don\'t have any problem with it. I\'m just trying to think about the
overall credibility and value of the document if we\'re going to make
\--

MS. DILLEY: Ron.

MR. OLSON: Maybe the issue is more the last sentence rather than the
topic sentence. I mean, the issue is, could moral and ethical concerns
hamper the progress of biotechnology as opposed to stating some people
have concerns. I mean, okay, I hear what Michael\'s saying. So, the
question is, does that hinder or help the advancement of biotechnology
or does the USDA think about it at all, or, does anybody think it does
hinder or help. I mean, it doesn\'t help probably.

MS. DILLEY: Just like you did yesterday in terms of really clearly
articulating what the statement\'s trying to say and we selected
actually a clarifying sentence or the clarifying text to be the actual
statement. This may be the same situation, either Ron\'s suggestion or
what Greg just said in terms of people make decisions about their
products based on other than safety considerations such as, or,
something like that, I don\'t know.

But I think you may be right, Michael, that we need a better sentence
for the topic sentence that really expresses it more specifically.

DR. DYKES: I guess I\'m kind of where Ron is. Again, I don\'t disagree
with anything that you\'ve said, Greg. I just think that to improve the
report, and I don\'t want to belabor it too long because I could live
with what\'s discussed here. I\'m genuinely trying to go about improving
the value of the report. I think where Ron is, you know, concerns, other
than those addressed by the regulatory system, are unlikely to disappear
and may hamper. I mean, I really think that\'s the essence of what
we\'re trying \--

MR. OLSON: That\'s an issue, I think.

MS. DILLEY: Leon?

MR. CORZINE: If I may. I agree with what\'s been said and I think what
Greg has said is right. I think you get into the question to how long do
you make this because it is still the markets will dictate some of these
things and we\'ve stated that. What I have a lot of trouble with is that
last sentence because that\'s conjecture.

Now, my first choice would be to strike it. I can\'t live with it like
it is. I have another choice would be to replace it with \-- and the
words that are toughest for me is, are unlikely to disappear because we
don\'t know that. And if you replace that with could continue and, if
so, makes it more real world and then we\'re not into that speculation
mode.

MS. SULTON: Could continue and \--

MR. CORZINE: If so, may hamper.

MR. OLSON: Yeah, I agree with taking out the unlikely to disappear.
That\'s an opinion. And then maybe instead of hamper could you use the
word influence or something.

DR. DYKES: Yeah, hamper\'s a negative.

MS. DILLEY: Could affect development acceptance, could impact. Leon, are
you suggesting that that then be the topic statement or just to change
it in the text?

MR. CORZINE: I was just going to change that in the text. I hadn\'t even
looked at the topic statement as far as any changes to the topic
statement. But that sentence.

MS. DILLEY: But that seemed to be the sentence that you all were looking
at to maybe be the one that would replace the topic sentence, so, I
don\'t know what you think.

MR. OLSON: The only thing about the topic sentence, it\'s one of those
some think this way, some think this way. So, some think one way is the
topic sentence and then there\'s no other side to it. Maybe there isn\'t
another side.

DR. SCHECHTMAN: I don\'t think the topic sentence is the "Some members
of the committee\..."

MR. OLSON: The public.

DR. SCHECHTMAN: Yes.

DR. DYKES: But if you read this after reading the whole document,
Michael, I\'m not sure that that\'s the conclusion one would reach.

MR. JAFFE: Right.

MR. CORZINE: It doesn\'t start off very well starting off with some
members. It\'s not a very good sentence.

MR. JAFFE: And I suggest you change it back to a portion of the public
because it was an ambiguity. I don\'t think this was written as, some
members of the committee think this. I think it was saying that there\'s
a portion of the public who, and I think we all can agree there\'s a
portion of the public who has these concerns. Whether that\'s a small
portion or a large portion or how influential they are, we can all
disagree on it. It may depend on the issue, whether it\'s genetically
engineered corn, or wheat, or a cow, or something like that.

But, so, I sort of suggest changing that to a portion of the public
because then it would avoid that ambiguity.

MR. OLSON: Carol\'s suggestion was some people.

MS. DILLEY: So, a portion of the public have concerns about?

DR. DYKES: And she suggested some Americans.

MR. CORZINE: I like a portion of the public.

MS. DILLEY: A portion of the public have concerns about and then \--
has, sorry.

DR. LAYTON: Okay. What about the rest of it?

DR. DYKES: I guess, to me, another part of this discussion is one piece
is you can be concerned about whether it\'s safe or not. And then
there\'s another level of your concerns about when you go to purchase
it. So, you might define that they may be safe, but I still don\'t want
to purchase it. I wonder if we aren\'t differentiating these two.

I think there are two concerns here. One is, there are some people who
question whether it\'s still safe or not, but I think what we\'re trying
to convey here is even if you have a regulatory system that assesses
their safety and environmental and all the other stuff we got in here,
there are still people that have concerns when it comes to purchasing
because they want other things.

DR. LAYTON: So, do you really need the first sentence because those are
the people are just worried about food safety and we\'re talking about
the people who aren\'t worried about food safety.

DR. DYKES: No, they\'re worried about food safety, but they have
concerns beyond food safety.

MR. OLSON: Yes, yes.

DR. SCHECHTMAN: But do you want to address what you said by putting that
in the last sentence so the beginning of the sentence could be something
like these concerns may continue to impact the marketplace and may,
etc.?

DR. DYKES: Yeah, something like that. I\'m fine with that. I am being
genuine. I don\'t disagree with what Greg said. I\'m just trying to get
\-- I think if you sat here for three years and listened to the
discussion and you read this the discussion doesn\'t match with what
this says.

MS. DILLEY: Greg and then Mardi.

MR. JAFFE: I mean, just to say that first sentence, I mean, I don\'t \--
I mean, I don\'t disagree with Michael that maybe this whole thing could
be better written. I mean, I guess the question is, should we get a work
group together at some point this \--

DR. LAYTON: No.

MR. JAFFE: \-- morning and do that or something like that or whether
it\'s not the best artfully worded thing, but it\'s not bad and just go
with it, although it may not convey things as best as we can. I happen
to think that first sentence, I mean, I don\'t know anybody who just
considers the food as safe. I mean, if I go and tell you this yucca
thing is safe how many people in the room are going to want to eat the
yucca thing, you know, the yucca plant.

I mean, just because it\'s safe doesn\'t mean we\'re going to eat it.
So, I think we\'ve said a little too much here in that first sentence.
Is it, you know, a drop dead issue, no.

DR. DYKES: No.

MR. JAFFE: But I think the point we\'re trying to make is contrast. Do
we need to make that contrast or just say in addition to safety, other
factors \-- you know \-- one considers other factors or something like
that.

MS. DILLEY: Right. Just shorten it and say in addition to safety people
consider x, y, and z.

DR. DYKES: It seems to me this is an issue that although we\'ve been
working on the last statement, some people have concerns that go beyond
the standard regulatory safety assessments and if they continue they may
impact the overall acceptance, or whatever we say, of biotech.

I think that pretty well sums up what we\'re trying to say, go on and on
for pages about it, but, in essence, that\'s what we\'re saying.

MS. DILLEY: Right. Mardi, did you have a suggestion?

DR. MELLON: Well, I agree. I like Leon\'s formulation, a more general
one, but because I believe that this does profoundly affect regulation,
not just \-- the regulatory process, not just consumer behavior in the
marketplace. It is \-- I mean, the dynamic is that people who have
concerns other than safety concerns have nowhere to go to take those
concerns, to have them addressed, to have them listened to and by
default they end up at the regulatory \-- at the door of regulatory
agencies making safety arguments even though those safety arguments are
often not the most important thing to them.

But because there is nowhere else to go they are at the front door of
the FDA and, you know, when you say how can we influence a decision
about this technology; how can we mold it or stop this part of it, you
have very few doors. You know, you can through basically door number one
which is go to the agency that can approve it. And if you go there,
those folks are statutorily unable to hear anything but health, safety,
and environmental concerns.

So, it does disturb the dynamic. Now, I don\'t know that we need to say
that except that I think that Leon\'s formulation, which is it defeats
things, you know, to the extent that these things can continue they
influence the course of the technology. I think it is better than trying
to kind of narrow it to just once the products are in the marketplace
people are going to bring this large set of concerns to bear on whether
or not they purchase a particular product.

MS. DILLEY: I mean, to me, that\'s almost a different point that you\'re
making because what emphasizes here is all the different ways people
make decisions about it, not the fault of the regulatory system in terms
of \-- not a fault of the regulatory system, but an outlet to talk about
those issues so that\'s actually a different \--

DR. MELLON: I think it\'s all these things. It\'s when people say I
don\'t want to buy this, but people are going to put it on the
marketplace, unlabeled, and I\'m going to have to. They are not driven
to the streets by the notion that it\'s not safe. They\'re driven by
their own set of moral, ethical, all these other values that say how can
I \-- wait, don\'t do that to me.

MS. DILLEY: Well, 23 is where we get to labeling. So, I don\'t know if
we want to lump all this stuff together. But Leon and then Michael and
then Greg.

MR. CORZINE: I wonder if maybe on that sentence rather than hamper \--

MS. DILLEY: We said put impact.

MR. CORZINE: Yeah, put impact or influence, so, that\'s fine with me.
The other question that I had. Do we need that example sentence in there
just in the interest of being a little more precise? We address things
but we\'re kind of picking on the animals here a little bit.

DR. MELLON: I think that is pretty important. I mean, it is the animals
where these ethical concerns are.

MS. DILLEY: Well, maybe, Mardi, if you want to emphasize the point you
just made I don\'t know if that one gets it. I mean, it may just be that
right now because there is no established regulatory process for
transgenic animals there\'s no venue to address issues, the wide range
of issues that people \-- I mean, that you just mentioned. I mean,
that\'s a different point than I think the way it\'s framed in here now.

MR. GRANT: A better example would be some consumers choose organic, for
example, because that is in the marketplace today. Those are choices
that are actively being made. This one about genetically engineered
animals is really a theoretical choice and we really don\'t even have
the option to make yet and, so, it\'s a little bit conjecture to put it
out there as an example of choices that consumers would make because we
really don\'t know. They haven\'t made that choice yet.

DR. MELLON: We do know from the people that they are \-- and from a lot
of polls there is a lot of disquiet and discomfort about genetically
engineered and cloned animals and those register very high. They impact
the food industry and its decisions. So, I mean, just in terms of making
it a useful document I think it is a good point to flag.

I mean, it is \-- the choices aren\'t there, but the data are there and
that is a proven kind of set of attitudes. That\'s a proven attitude.

MS. DILLEY: It may not be that example itself. It may be what you\'re
trying to say is the example. If we can find some language, and I may be
wrong about that, but \-- Michael and then Greg.

DR. DYKES: I\'m more kind of where Mardi is. And I agree with Mardi. I
think a lot of the arguments we see on biotech today are wrapped in the
safety argument. I\'m not sure if people really genuinely think there
are safety issues, but, because the process was based on safety there\'s
a feeling that we\'ve got to argue safety to be heard.

But, I philosophically agree. I think a lot of the arguments we hear
today are veiled in safety when really they aren\'t safety issues. I
maybe would suggest that, and I kind of agree with Mardi, if we look at
where this thing should advise the Secretary, if you think about this,
we\'re saying there are issues out there that are in the level, in the
noise of the concerns about biotech and they may not go away because
they won\'t be addressed by a pure scientific review of the things
because there are other avenues of concerns beyond that, and as an
example of where this is likely to take the next bump up is when the
transgenic animals come around because you\'re going to highlight this
level of concern when you get to that category.

MS. DILLEY: Yeah.

DR. DYKES: So, to me, that\'s where the example fits in is just looking
ahead. This thing we\'re telling you about today may not have a lot of
relevancy to it, but, if you apply it to the animals when they do come
you\'re going to see this thing bumped up. So, I would suggest maybe
take the topic sentence with the changes, a portion of the public or
something, where we were, and maybe replace genetically engineered foods
with products because I think it\'s beyond

\-- it\'s probably beyond foods.

And we take the changes we made in the last sentence and maybe it\'s
generic enough and conveys the point enough that we move on.

MS. DILLEY: Okay. Greg and then Randy.

MR. JAFFE: I mean, I was going to say that \-- I guess I\'m not sure
where we were going with the topic sentence or not, but I think it\'s
important to keep in the relationship to the regulatory system. We\'re
talking to the Secretary of Agriculture. That\'s the important thing
here is to convey that there are things outside that system that are
going to impact this technology and the adoption of the technology.

MS. DILLEY: Right. So, let me just stop you there because I know right
now we\'re working off the sentence that says a portion of the public
has concerns about genetically engineered products that are not
addressed by the regulatory system designed to assess and manage health
and safety regs.

MR. JAFFE: And I\'m fine with that.

MS. DILLEY: That\'s where we are right now. It doesn\'t mean \--

MR. JAFFE: But I think the example of the animals is very important to
Carol and I think it is a real example. I don\'t have a problem putting
in another example in of organic. I think the more examples the better
and if there are ways to get rid of the first sentence and just start by
saying, you know, in addition to safety other factors, you know, the
public considers other factors or something like that and then if you
want to add other examples that\'s fine.

But I think that Carol\'s not here right now, but I know that she feels
very, very strongly that that\'s an example and I think \--

MS. DILLEY: Well, I don\'t know, and maybe the way to change it again is
just to go back to what Michael said which is as an example, transgenic
animals. These issues will become more critical. I can\'t remember
exactly how you said it, but the general direction was they\'ll become
more critical as transgenic products such as \-- future products such as
transgenic animals make their way to the marketplace or \--

DR. DYKES: Well, I\'d just leave it the way it is for me. I think just
the example\'s fine.

MS. DILLEY: Okay.

DR. DYKES: I think, to me, this animal thing highlights more
specifically what we\'re trying to convey here than does organic because
to me the organic is more the labeling, a labeling solution. This is
something higher level than just even if these animals were labeled, I
don\'t think that would be sufficient.

MS. DILLEY: Okay. So, let me get Randy. I\'m sorry, Greg, did I cut you
off?

MR. JAFFE: No.

MS. DILLEY: You were finished. Randy and then Ron.

MR. GIROUX: Just two comments. First of all, I thought we\'re dealing
with a lot of topics so I wanted to go back to finishing the sentences.
Secondly, I have to disagree with you, Mardi that there are choices in
the market. Markets do listen to their customers and if people can\'t
\-- if people are going to the regulatory system because they can\'t
find in the market the products they want, I don\'t believe for a minute
that if a large portion of the population was calling food companies and
saying we want non-GM products that those companies wouldn\'t respond.
Now, there are products in the market that are non-GM. There are more
and more in the marketplace. And, so, I\'m struggling to believe that
there\'s a large portion of consumers out there who are not being
marketed to. I believe that if there are large markets, these food
companies listen to their customers. And if there was compelling, large
portions of the market that wanted those products they would be there.
There are more and more. How big that market is I think is a big
question to everybody.

But the markets will respond to the demands and, so, we may have a
problem with that.

DR. MELLON: I\'m sorry. I mean, I believe that. I plan on using that
power if they try to approve cloned animals. I mean, to go to the food
companies because I agree that the market matters. I\'m just saying that
in addition to that dimension there is a distortion of the safety debate
that comes from this. There is no place to take those concerns.

If you go to the FDA and go to Kathleen and you say we\'re concerned
about this because of \-- we think it\'s safe but it\'s morally
objectionable, the FDA \-- and we want you to do something about it, we
want you to label it, or, restrict its availability in the marketplace,
or, something like that, she will say, I may or may not agree with you,
but we don\'t have the power to do anything on the basis of your
concerns about your moral concerns.

If you can make a safety case, come on back, we\'ll listen to you. And I
think both are at work. But I think it is important that this \--

DR. LAYTON: Hampers the future or whatever.

DR. MELLON: \-- the handling of some of the issues. You know, when
you\'ve got a multitude of issues and one really \-- and that\'s the one
that can get you where you want to go that\'s the one that you choose to
lead with. So, I do agree with you completely and I think the market is
out there as responsive.

MS. DILLEY: Because, Randy, I think we\'re getting to the language
actually. A portion of the public has concerns about genetically
engineered products that are not addressed by the regulatory system
designed. So, we\'ve got that, the rest of it.

DR. DYKES: Well, maybe we should leave that as some people, as Carol
suggested, because then it flows some people and then others if you read
the text. Some people in the topic sentence I don\'t have a problem, but
the rest of the text will flow better if you leave it some people.

MS. DILLEY: Okay. Then I thought we were kind of, well, maybe we don\'t
want to do this, but I thought in addition to safety other factors such
as moral and ethical considerations or whatever you want \-- whatever
factors you want to take out of that one to condense it \-- are
considered by consumers in purchasing their foods or something like that
and then the new sentence of concerns other than, let\'s see, these
concerns not addressed by regulatory \-- sorry, I was trying, but I\'m
not quite there yet.

But then the last sentence says how Leon modified it and then with the
example and then that\'s it. I don\'t know if that\'s \-- Ron, I know
you were next and then Alison.

MR. OLSON: It\'s actually minor. Pick up on what Duane said about the
animals and we\'re not there yet. So, if you read this as an uneducated
person you kind of assume they\'re already out there. So, what if you
say when and if they arrive, you know, something that kind of qualifies
it, if and when.

MS. DILLEY: I see. Yeah, it sounds like it\'s \--

DR. SCHECHTMAN: If and when they enter the food supply?

MR. OLSON: Yes. Something like that.

MS. DILLEY: Okay.

MR. JAFFE: Well, they say some \-- I mean, the sentences read some find
genetically engineered animals to be ethically problematic. I mean,
there are \--

DR. LAYTON: And may object.

MR. JAFFE: And may object to the presence in the food supply. It
doesn\'t say we may object if they go into the food supply. I mean, if
you want to say that, that\'s fine.

MR. OLSON: Yeah, something like that.

MR. JAFFE: May object to the presence of these animals if they end up in
the food supply.

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

MR. OLSON: Something like that.

DR. DYKES: That\'s what he said, Greg.

MR. JAFFE: Okay.

DR. DYKES: If and when in the food supply.

MS. DILLEY: Okay. Alison, you had a comment and then Michael.

DR. VAN EENENNAAM: I kind of agree with Greg because I don\'t know
anybody that makes a decision on food based on safety as legally
defined.

MS. DILLEY: That\'s why I was trying to shorten it.

DR. VAN EENENNAAM: Well, I wondered and I think in addition to safety I
think some people with the acceptability of food in terms of these
factors just remove the other group that does this legal thing when they
make their food decisions. So, in addition to safety some people
consider \--

MR. JAFFE: Right, just consider.

DR. VAN EENENNAAM: \-- other factors. They kind of take out other
factors in their food purchase decisions or I don\'t know how we want to
put that and then just their concern with \-- I don\'t know if people
are involved with this language in their food purchasing decisions.

MR. JAFFE: Most people consider most foods to be safe. I think that is a
given.

DR. VAN EENENNAAM: Right. They are concerned with a product\'s origin,
or, I think we\'re good there. They are concerned with \--

DR. LAYTON: May be concerned.

DR. VAN EENENNAAM: May be also concerned.

MS. DILLEY: Go ahead Alison.

DR. VAN EENENNAAM: She\'s got it. They also may be concerned with the
product\'s origin and whether foods are wholesome, pure, and natural.

MS. DILLEY: Okay. Michael, your card was up, Russ, and then Mardi.

DR. DYKES: Yeah. I think you could make some statement, most people
think that their food is safe if it\'s gone through the process, but
there are other factors that influence purchasing decisions beyond
safety such as products origin, whether they\'re wholesome, whether
they\'re pure, whether they\'re whatever.

DR. LAYTON: So, most people consider foods safe and are more concerned
\-- and consider other factors?

DR. DYKES: But there are other factors that influence food purchase
decisions such as.

DR. LAYTON: But there are other factors.

MR. JAFFE: I mean, see, I think you start changing when you say relation
to safety people consider other factors. I think that\'s fine. But when
you sort of say most consider food safe, I mean, I think people know if
you eat raw chicken it\'s not safe. I mean, people consider food safe if
it\'s prepared correctly and if it\'s \-- I mean, they understand \-- I
mean, people understand there\'s lot of risks in lots of foods. I think
that\'s when you start \-- I don\'t think \--

DR. DYKES: I was just trying to capture and I didn\'t give all the \-- I
was just trying to pick up on what you were saying. I agree that, you
know, people think food is safe if it\'s cooked properly, if it\'s
stored properly. If it\'s on the market I think most people think, yeah,
it\'s not going to hurt me to eat it. I\'m not afraid to eat it. I may
choose not to eat it for a whole variety of other reasons.

MR. GRANT: Right. So, could you say that?

DR. SCHECHTMAN: Something like some people assume that foods that are
legally sold and available in the marketplace are generally safe?

DR. MELLON: Some people assume that?

MS. DILLEY: I would just say in addition to safety. It\'s a lot easier
way. I think Russ was next and then Mardi.

DR. MELLON: I mean, I wouldn\'t \-- just because we have so much work to
do, I would prefer to just, with the changes that we\'ve made, to just
leave it as it is. I think it is \-- to me, it\'s accurate. It may not
be the best of all possible worlds, but you know, it\'s 90 percent there
and we should go on.

Having said that, I would say that we might want to use the term
Americans rather than people just to emphasize to the Secretary that
these are not \-- you know \-- we\'re not talking here about the
Europeans and their views of the technology; that these are issues that
are going to confront the USDA in the domestic context.

DR. CRAMER: So, you want Americans in the topic sentence?

DR. MELLON: I like that, but I\'m also \-- I don\'t \-- you know, we\'ve
got \--

MS. DILLEY: In other parts of the document we talk about members of the
public or consumers. I guess we were assuming that it\'s \-- I don\'t
know if we need to qualify that as Americans or not. Can we just \-- no?
Let\'s keep it as people. Russell?

MR. KREMER: Yeah. I guess I had a question, I guess maybe. Are farmers
considered consumers in this thing? I know this thing is directed toward
consumers according to the text.

MS. DILLEY: Well, we now have some people.

MR. KREMER: Some people, yeah. But I guess my point is, because I don\'t
think it\'s addressed anywhere else, the same sort of concerns on the
farmers\' side. I mean, you know, most farmers believe the stuff is
safe. However, for instance, there\'s a larger faction now that are
resisting biotech because of the control issue, you know, who actually
controls it. They have a problem with the patented life forms. They have
a problem with not being able to save their own seeds. They have a
problem with signing different documents that restrict their
independence.

And I was just wondering if farmers are considered consumers, can we
just simply change, you know, one word. You know, instead of saying
engineered food, maybe engineered products.

MS. DILLEY: Yeah, that\'s good.

DR. VAN EENENNAAM: I think we already did that.

MS. DILLEY: It is genetically engineered products.

MR. KREMER: Okay. I\'m sorry. Okay. I think that would cover \--

MS. DILLEY: You\'re right in the corner and you can\'t see.

MR. KREMER: \-- unless it\'s somewhere else in there.

MS. DILLEY: So, that\'s acceptable then. I would suggest that we take
Mardi\'s suggestion of holding this now because I think we\'ve fine
tuned it and move onto the next topic.

MR. KREMER: I\'d just make sure if it says food anywhere else or if it
says consumers anywhere else maybe it should be changed to people.

MS. DILLEY: Okay. So, it says some people. Later on, it does say some
consumers may raise moral or ethical issues.

MR. CORZINE: I think we are consumers.

MR. KREMER: We are consumers?

MR. CORZINE: I think we\'re consumers.

MR. KREMER: I have no problem with that.

MS. DILLEY: Okay. Great. If we can come back to 14 because we had a
group that was trying to fine tune the language, at least one group\'s
language, one of three or four. So, let\'s go back to 14 and remind
ourselves.

Okay. So, Carole, I think you had language that is in hard copy but
it\'s only in that one paragraph, right? So, I need \--

DR. CRAMER: I have electronic.

MS. DILLEY: I know, but I \-- okay. But they don\'t have a copy of the
language up here, so, we\'re going to have to read it.

DR. CRAMER: It\'s up there.

MS. DILLEY: I know, but okay, so, you don\'t want it in context of the
rest of the thing?

DR. LAYTON: Both of them are up there. We can go between documents.

MS. DILLEY: I didn\'t know if people wanted to refresh their memory of
the new language that we have before we enter that. Okay. So, what we
have now is there is a major concern that food crops genetically
engineered to produce medical and industrial products never intended for
food or feed use could inadvertently end up in a food or feed product.
New genetically engineered organisms designed for medical and industrial
markets could offer substantial health and economic benefits.

There are a number of new products under active development in these
categories and some of those being produced in plants have been
engineered for production using important food crops. Consumers
generally do not want such substances in their food.

One group of committee members believes that the Federal Government
should not approve the use of food crops for the production of medical
and industrial substances even if the substances are deemed safe because
no regulatory process or containment system can assure that these
products will never enter the food supply.

Then we have the new language. No? Okay. Other members believe that
adequate \--

MR. JAFFE: This is the old language.

DR. CRAMER: This is to replace that.

MR. JAFFE: No.

DR. CRAMER: No?

MR. JAFFE: No.

DR. SCHECHTMAN: That\'s \--

DR. CRAMER: This is the new language for that.

DR. LAYTON: It\'s okay, Michael.

DR. SCHECHTMAN: Okay. Go ahead.

MS. DILLEY: Okay. So, other committee members believe that adequate
regulatory oversight of crops producing medical or industrial products
utilizing a tiered risk-based approach can assure \-- can ensure the
safety and integrity of the food and feed supply. These members believe
that at small scale complete segregation from food products can be
ensured by a combination of physical and biological containment
strategies. As scale or potential risk increases food safety assessment
may be required in addition to stringent containment procedures.

That\'s the new language, those three sentences.

DR. SHURDUT: You may want to look at number three.

DR. CRAMER: Go back to three. Still another group.

MS. DILLEY: Still another group prefers the use of non-food crops for
such products. They believe that if food crops are to be used it is
impossible to guarantee the absolute absence of such substances in the
food supply. Therefore, in their view, no food crops should be used
without thorough regulatory review of food safety and the establishment
of stringent safeguards to prevent intermingling with the food supply.

DR. LAYTON: And then the last sentence.

MS. DILLEY: Okay. Which is the last sentence, the Federal Government\'s
ability to? The Federal Government\'s ability to successfully address
the issues of containment and public confidence in that containment
system remains critical for the development of these products, period.

(Discussion off the record)

MS. DILLEY: Cool. Good work.

DR. VAN EENENNAAM: So, it was one bit that read a bit rough up at the
top and I don\'t know \--

MS. DILLEY: Do you want to edit?

DR. VAN EENENNAAM: Okay.

MS. DILLEY: Let sleeping dogs lie, as they say.

DR. VAN EENENNAAM: Let sleeping dogs lie, please.

(Discussion off the record)

MS. DILLEY: Okay. So, I don\'t know if this is also a let sleeping dogs
lie, but on 17, I think we\'ve talked that until we\'re all talked
potentially out, I\'m hoping. And, so, I\'m hoping that this captures
the some members think, others, so, I\'m not sure we need to open this
up at all.

We received no comments on this one so I just want to be sure.

MR. JAFFE: Wait a second. We didn\'t get it.

MS. DILLEY: 17, you did. That\'s 23 you\'re talking about.

MR. JAFFE: No.

MS. DILLEY: 17.

DR. DYKES: I thought you said yesterday you went 1 through 18.

DR. VAN EENENNAAM: Greg commented at the very end of the side-by-side.

DR. LAYTON: That was on the original text that you had comments on. This
is not the original text.

MS. DILLEY: Okay, I didn\'t know that.

MR. JAFFE: That\'s right. This text, in 17 here, there\'s no comments
because nobody received this text to provide comments on.

MS. DILLEY: 17?

MR. JAFFE: That\'s right.

MS. DILLEY: I think that\'s incorrect.

DR. LAYTON: The second version I sent, the side-by-side for editing had
the right text in it. The version that I sent out that would look like a
regular, normal paper, I don\'t know.

MR. JAFFE: Well, I got it not.

DR. LAYTON: I agree with you, Greg.

MR. JAFFE: Here is the 17. I have my draft, 17, that was sent out for
comment on the 14th.

MS. DILLEY: I\'m wrong, you\'re right. I thought it had gone out.

MR. JAFFE: It did not. It came in \-- it came with the \--

DR. LAYTON: Do we have a revised version of 17? There is another 17
topic. Wait a minute, let me see if I can\'t pull it out. A combined
topic 17 is the last one I have which I thought was in the file that you
all have.

MS. DILLEY: But then, I don\'t know if this is the best one to take up
because I didn\'t realize that it was my error. I obviously didn\'t look
at the document closely enough when it went out. So, I don\'t know if
you guys want to look at it before we take it on, so maybe we take it on
after lunch.

DR. LAYTON: I don\'t know if that\'s not what\'s in your document. I
thought it\'s what\'s in your document.

DR. DYKES: Well, I have the document that I commented on in my own
comments, and on 17 I had a topic sentence and then I have a sentence
and a bunch of strikeouts and then a sentence at the end.

DR. LAYTON: Right, but the document that we\'re editing from, you know,
this one, I don\'t think it has the strikeouts in it, number 17, which
is the right 17, I think.

MR. JAFFE: Abby, what happened was that the draft that went onto 14, we
had a conference call about this in early December.

DR. LAYTON: Right.

MR. JAFFE: Michael had asked me by Friday, December 4th to get him \--
we decided to do it as some say this, some say that, asked me to provide
him some language by Friday afternoon, December 4th, I think it was. I
said I would try and do that. I did, in fact, do that.

DR. SCHECHTMAN: No, we did that. We got language from the other side. We
combined them.

MR. JAFFE: That was not included in the \--

DR. SCHECHTMAN: I don\'t know exactly if it\'s \-- everyone did what \--

MR. JAFFE: It was not included in the December 14th draft that went out
for comment.

DR. LAYTON: Right.

MR. JAFFE: It was included \--

DR. LAYTON: In the side-by-side.

MR. JAFFE: \-- in the side-by-side on the 22nd that went out to people.

DR. LAYTON: Right.

MR. JAFFE: But that\'s why you have a blank on the right side because
nobody had seen it to provide comments on it.

MS. DILLEY: That makes sense.

MR. JAFFE: So, I would suggest that people look at that over lunch and
we take that up the first thing after lunch.

DR. LAYTON: Yeah, come back to it after lunch.

DR. DYKES: Just so we\'re clear on what to look at. Please look at the
document you handed us yesterday morning.

DR. LAYTON: We\'ve got line numbers on it.

DR. DYKES: With the line numbers on it.

DR. LAYTON: That\'s it.

DR. DYKES: That is the language. Okay.

MS. DILLEY: Right. So, please review that one which is on page 15 of the
lined document.

DR. LAYTON: It\'s 17 in my document.

MS. DILLEY: Okay.

DR. LAYTON: It\'s on page 17. I didn\'t have it in time to send it
originally out for editing, Greg. That was the deal.

MR. JAFFE: I\'m not blaming anybody. I\'m just describing a series of
\--

DR. LAYTON: That did happen. I knew I had sent it out, but I couldn\'t
figure out \--

MS. DILLEY: Okay. So table that and review that at lunch and we\'ll come
back to it after lunch.

DR. LAYTON: Okay.

MS. DILLEY: It\'s my fault completely. Thank you, Michael.

DR. LAYTON: Okay. Next?

MS. DILLEY: There are some topics you really can\'t take up without
Carol here.

DR. DYKES: Which one are we going to now then?

MS. DILLEY: I\'m looking, hold on.

DR. DYKES: We haven\'t done number 2 yet.

MS. DILLEY: Well, I mean, we can hit some of the more editorial, I
think, in nature, but if you have \--

MR. JAFFE: How about 25?

MS. DILLEY: Number 25 is the market access to another government\'s
moratoria. Okay. Let\'s hit 25.

MR. JAFFE: Are you looking for a difficult one or are you looking for an
easy one?

MS. DILLEY: Well, what\'s your sense of 25, Greg?

MR. JAFFE: It depends on how compromising a room we\'ve got.

MS. DILLEY: 25 was on my list.

DR. MELLON: And, remember, Carol\'s not here.

MS. DILLEY: And I think you had more comments on this and people aren\'t
here as well.

DR. LAYTON: Now, this has also been revised and did you all get to edit
it before?

MS. DILLEY: So, it\'s on page 23 of the version that was handed out and
on the colorful document it\'s on page 17. And you also have the
compilation of comments on the side-by-side.

DR. LAYTON: Okay. We can take the note out. Everybody knows what
happened.

MS. DILLEY: So, why don\'t you take a minute \--

DR. LAYTON: You can delete the note at the beginning.

MS. DILLEY: Why don\'t you take a minute or two to review topic 25 and
the comments.

DR. LAYTON: My note just had to do with the last plenary. Did this need
a counter-argument? Randy, I know you saw that.

MR. GIROUX: Yes, it does.

DR. LAYTON: If others don\'t is not appropriate?

MR. JAFFE: If you look at my draft I did suggest language.

(Discussion off the record)

MR. CORZINE: On line 17 at the bottom we\'ve got commodities in there. I
think it should be products.

MS. DILLEY: Okay.

MR. CORZINE: And I wonder, in the examples of countries if you should
include Argentina because Argentina has \-- I think they still have the
highest percentage of biotech corn than any other country in the world.

DR. SCHECHTMAN: Well, but they are one of the few countries that
consider economic and they have no \-- I mean, it is one of the two
examples.

MR. JAFFE: I think it\'s a wrong example.

DR. DYKES: I think it\'s a perfect example because I think they are one
of the two because when you do the scientific reviews before they give
you the final approval they check to see if it\'s approved in Europe. If
it isn\'t then they come up with a whole bunch of other reasons why you
don\'t get approval. As soon as it gets approved in Europe they approve
the next day. That\'s the way it works in reality.

MS. DILLEY: But is it slow? They had such economic concerns but did it
slow entry of products?

DR. DYKES: As far as entry of products into Argentina?

MR. CORZINE: Aren\'t they still the highest percentage?

DR. DYKES: Well, in terms of soybeans and the corns that they have
approved. But they won\'t approve new corns unless they\'ve been
approved in Europe.

MS. DILLEY: Greg.

MR. JAFFE: Since we\'re on the socioeconomic, that\'s my big concern
here. I do not agree with the statements. I don\'t think they\'re
accurate. And, so, I proposed some alternative language for \-- to put
in the text if it\'s going to stay, a sentence about socioeconomic.
First of all, I don\'t think it \-- I think you\'re mixing apples and
oranges and I\'ve said that before at the last plenary that, you know,
it\'s one thing to talk about moratoria and I think we all can agree
that moratoria hindered development and trade in this state.

Adding in socioeconomic factors, they\'re not moratoria. It\'s something
different. It\'s a factor in a regulatory system. And, so, I think \--
my view is you\'re adding apples and oranges. So, my preference is that
they be deleted from this issue. I don\'t think they\'re related.

If they\'re kept in, and I\'ve made that argument before, then I feel
the need to have to say some members say this and some members say that
because I don\'t think that the section here is saying that, are
inhibiting the development. I don\'t \-- I don\'t see evidence of that.
I think there\'s been very little done on socioeconomic considerations
to know whether it\'s hindering or not hindering.

Argentina is one of the largest growers of these crops and is growing
huge quantities of them. They\'re not, in my mind, hindering the
development of them. They\'re also a secondary market. They\'re not the
primary market.

MS. DILLEY: Well, you can separate those out though. I mean, whether \--

MR. JAFFE: And, South Africa is the biggest grower in Africa of these
crops and they have more crops grown and approved than anyone else. They
have dozens of field trials. I don\'t think this is hindering the
development of them in South Africa and I don\'t think it\'s swelling an
investment in South Africa. Now, I may be wrong on that, but I think
that these statements are too broad and too all encompassing to fit
within that or to compromise.

My suggestion would be, one, to delete from the topic sentence that
second sentence. If you want to put such moratoria and the incorporation
I think the topic can stand with just the first topic sentence and if
you want to take the second topic sentence and fold it into the text,
that\'s fine with me, that some members believe. I think if you keep it
in the topic sentence then you have to have another topic sentence that
says other members believe.

I don\'t think you can just leave it some moratoria. I\'m not
comfortable leaving the second sentence in without a "some members" in
the topic sentence.

MS. DILLEY: Right.

MR. JAFFE: And then I\'ve included in my proposed draft if you\'re going
to include the sentences later on in the text about socioeconomic
consideration then I\'ve added a sentence that I think captures, at
least, my point of view. I don\'t know if there are other members, other
AC members see no evidence of socioeconomic considerations within the
regulatory process that prevented a transgenic crop from being
commercialized.

I believe there are ways that those issues could be addressed by the
government without impacting trade from the United States.

DR. LAYTON: Our government or their government?

MR. JAFFE: Their government.

MS. DILLEY: So, just to clarify. So, in terms of offering alternative
language, I mean, wouldn\'t the topic statement be fine if you \-- and
this is a question, but from your perspective, if you disaggregated the
moratoria and the socioeconomic so that it would read such moratoria
could also inhibit the development and deployment of potentially useful
new crops? It\'s decoupling the moratoria and the socioeconomic factors.

Now, whether other people agree with that, I don\'t know, but I think
you\'re making two different points in my mind. One point is, you\'re
making socioeconomic and moratoria together as problematic. The other is
whether you agree or disagree. I mean, and that\'s a question to the
group in terms of whether you want to talk about socioeconomic issues in
here and whether they have slowed in particular examples and that may
result in the some members think this and other members think that,
which is your other suggestion for language.

If that stays in, and you disagree with that, and we\'ve got some think
this, some think that. It sounds like there\'s no disagreement that
moratoria inhibit, so, maybe that\'s what could stay in the topic
sentence and then \--

MR. JAFFE: I mean, you could add that second phrase just to the first
sentence. I mean, I don\'t think you need a second sentence with what
you just said.

MS. DILLEY: Right, so, you don\'t need such moratoria because you don\'t
have it as lengthy, but so, you could actually condense that topic
sentence to address specifically moratoria. Then the group needs to
decide whether you want to bring up socioeconomic issues and then we
have some members think and other members think.

I don\'t see any disagreement with that, but I want to ask the group.
Michael, your card\'s up.

DR. DYKES: First, I want to \-- I\'m okay with leaving the topic
sentence contained to the moratoria. It is an accurate statement on
Argentina. It is blatantly socioeconomic. They will not approve, there
is evidence, has been, they will not approve another new corn variety
until it\'s been approved in Europe because it will impact their markets
to Europe.

So, I mean, there is clear, unequivocal evidence that it has been \--

MS. DILLEY: But is it specific to socioeconomic dimension of the
regulatory system? Is that what you\'re saying?

DR. DYKES: Yes. No, not exactly.

MS. ZANNONI: They told companies that they weren\'t going to approve
until they had the European approval because they don\'t want to deal
with their marketing and trade issues.

DR. LAYTON: So, you use the word market instead of socioeconomic?

MS. DILLEY: Leon and then Mardi.

MR. CORZINE: Well, I think socioeconomic is right because if you even
look at the European system, if things make it through their food safety
review the only thing holding it up is what their socioeconomic which
becomes political.

MR. JAFFE: Political. They have a political vote. What stops it is a
political vote, not a socioeconomic regulatory process. It\'s not a
socioeconomic regulatory process. You\'re mixing two things.

DR. DYKES: Essentially, no, it\'s not any regulatory.

MR. JAFFE: You\'re mixing two things there.

DR. DYKES: Socioeconomic is not in the regulatory.

MR. JAFFE: You\'re mixing two things there.

DR. DYKES: Socioeconomic is not in the regulatory, Greg.

MS. DILLEY: Right.

MR. CORZINE: But it drives the political.

DR. DYKES: Exactly does.

MR. JAFFE: But it\'s not a socioeconomic criteria. MS. DILLEY: Right.

MR. JAFFE: You\'re talking about the moratoria and regulatory process
and then you\'re adding \-- I agree that clearly the European system,
it\'s a political vote. They make a political vote. If they clearly \--
they do polls, they do all kinds of other stuff. It\'s not scientific.

DR. DYKES: Yes.

MR. JAFFE: I\'m not for that system. But it\'s not \-- you\'re equating
that with Argentina and South Africa which is specifically saying in
their regulations one of the steps to approval is doing a socioeconomic
analysis.

MR. CORZINE: Well, can you say something that\'s

\-- I think socioeconomic is appropriate in there. Maybe you put it,
Greg, that that drives political decisions to continue the moratoria or
something like that because it does.

MR. JAFFE: You want to make this specific to the EU and say \-- talk
about just the EU here, that\'s fine.

MS. DILLEY: Yeah, I mean, I think what you\'re having a problem with is,
you know, socioeconomic affects political. Political affects rapidity of
products into the marketplace and saying just socioeconomic affects
rapidity of products in the marketplace there\'s a missing link there.
So, you\'ve got a \--

MR. JAFFE: I\'m talking about \-- this, in my mind, is about regulatory
processes.

MS. DILLEY: Regulatory processes, yes, I know.

MR. JAFFE: And that\'s what we should be sticking with. And there are
clearly socioeconomic considerations taken into account in Argentina and
South Africa.

MS. DILLEY: So, we just need to find language, I think. We need to find
language to see if we can say it in a unified way or we need some
members think and other members think. So, I think we\'ve stuck with the
moratoria in the topic sentence, but now I need to figure out what the
particular language down here is.

Mardi, did you have \--

DR. MELLON: I\'m still not sure the point of this. I mean, are we trying
to say that \-- and, it is a fact that in a world trading system if some
people want products, they\'re sovereign countries, they can decide they
want them and others don\'t, it\'s going to be more difficult to have a
free-flowing international commerce. I mean, that\'s a fact and I\'m
sure that it is a fact that if countries set a moratoria, whether
they\'re formal or informal, it\'s going to impact world trade.

But I don\'t know what \-- I mean, what are we \-- what is the insight
we\'re trying to give to the Secretary of Agriculture? Are we trying to
tell him this is a fact; are we trying to tell him that these are
political decisions and that they need to be addressed politically? I
mean, what are we trying to say? Is there an avenue suggested here that
these regulatory systems are \-- I mean, I think they\'re legitimate
regulatory systems.

If they want to put social and economic considerations into their
regulatory systems that\'s what they get to do. I mean, these are just
the facts of life in the marketplace. And I don\'t mind making a
statement about this, although I agree, it kind of has to be probably
balanced in some way, but I want to \-- I mean, what is it we\'re trying
to say to the Secretary of Agriculture?

You know, what is the deal? Is it face the fact that this is a political
decision that you\'re going to have to continue to address on a
political level, or, there are \-- you know \-- there might be another
way of going about it? I just don\'t quite get it.

MS. DILLEY: Duane, you had a comment and then Russell.

MR. GRANT: Yes. Yeah, and I don\'t disagree with you, Mardi. I think
we\'re probably trying to restate something that\'s probably one of the
most obvious points of contention in international trade right now, so
it\'s amazing that we can\'t get it right because it\'s so prevalent.
But and I also don\'t completely disagree with you, Greg, although I do
somewhat.

There are some very real socioeconomic criteria contained in the
regulatory process of certain countries. Europe is an example in that to
approve a variety in Europe you have to demonstrate that the variety
will actually bring some kind of an economic benefit to the producers,
so, that\'s a socioeconomic concern if you can\'t demonstrate that.

And that\'s been one of the points that the regulators in Europe have
pushed back on is to show that you\'ll actually demonstrate to our
producers an economic benefit and into that equation then goes the
analysis of what will a GM crop sell for versus a non-GM crop and the
issue never really gets to be sorted out in the marketplace.

So, I think there are, and that\'s just one example, and I think you did
a study earlier, Greg, that highlighted some in South Africa and a
couple of other countries, I believe.

MR. JAFFE: South Africa and Argentina.

MR. GRANT: Yeah, okay. So, there are some that are out there. But I also
don\'t disagree that there\'s a very strong overriding political
component to the debate. So, I would suggest, maybe as a way to get
moving on this is just to, and we\'re really going to blend out with the
wording on this, but if we can, just to make the statement, insert the
word, political or socioeconomic criteria, just to make clear that
we\'re referencing more than just the regulatory process. There are
political considerations as well. And then move on on this.

MS. DILLEY: So, the incorporation of political and/or socio-economic
criteria?

DR. VAN EENENNAAM: I have a suggestion that maybe can get us moving
here.

MS. DILLEY: Okay.

DR. VAN EENENNAAM: That we leave the topic sentence as is, as Greg has
suggested, and then start with market access for transgenic varieties.
Accept the text all the way down to the bottom of the side-by-side
version to moratoria and then stop and then go \--

MS. DILLEY: That may have moratoria?

DR. VAN EENENNAAM: Right.

MS. DILLEY: Is that what you\'re saying?

DR. VAN EENENNAAM: Stop, and then, some members believe that the
incorporation of socioeconomic and political, whatever the wording that
was just suggested, into regulatory approval of processes such has been
done in Argentina can slow the entry and investment, blah, blah, blah,
and then Greg suggested other members believe that it hasn\'t had a good
effect or whatever your wording is there.

That way we all agree the moratoria has happened and then the fact that
some people believe socioeconomic factors is what according to what
different people believe \-- what different groups believe.

DR. MELLON: Is the issue whether they\'ve had an effect or whether
they\'re legitimate?

MR. JAFFE: Effect.

DR. MELLON: So, the fact is that in some cases, even though they\'re
there and they could have been used as a trade barrier, they appear not,
or, is that they\'ve been used as a barrier but it doesn\'t appear to
have an effect?

DR. DYKES: In my mind \--

MR. JAFFE: Alison, could you say what you \-- I didn\'t follow.

DR. VAN EENENNAAM: Well, I mean, the people \-- what the order was?

MR. JAFFE: Yes.

DR. VAN EENENNAAM: So, basically keep the \-- remove the second line of
the heading.

MR. JAFFE: Right.

DR. VAN EENENNAAM: Keep market access for transgenic varieties and
derived products.

MR. JAFFE: Right.

DR. VAN EENENNAAM: All the way down to the existence of such moratoria
is a disincentive for the development of new varieties and even for
trade with some nations without moratoria.

MR. JAFFE: Okay.

DR. VAN EENENNAAM: Then stop there and go with, some members believe
that socioeconomic criteria \-- the incorporation of such socioeconomic
criteria into regulatory approval processes, as has been done in
Argentina and South Africa, can slow the entry and investment in some
varieties in such markets, and I would probably think you should stop
there because if those people believe that then I don\'t think you can
say that there hasn\'t been strong evidence this has actually occurred.

And then go in with your suggested wording for the other members believe
that this problem hasn\'t had an effect on, I forget exactly how you
worded it, but \--

MR. JAFFE: That would be great. Good spirit of compromise.

DR. LAYTON: Good spirit of compromise. You need his text, I guess.

MS. DILLEY: So, are you referring to both socioeconomic and political?

MR. JAFFE: I\'ll let the group decide what they want to say.

MS. DILLEY: Okay. Okay. I just wasn\'t sure where we were inserting
socioeconomic and political. We\'re not adding political to your
statement. We\'re taking your language from here. Okay.

DR. MELLON: Then I want to say that sovereign countries \-- that some
people believe that sovereign countries have a right to condition
approvals on socioeconomic analyses and that, in fact, these have. I
mean, I think there\'s an implication that somehow these are not
legitimately used. We have, you know, politics drives our biotech debate
as, you know, overtly and strongly as anything I\'ve ever seen. And, so,
it just doesn\'t \-- I would not \-- I don\'t like the implication that
somehow those social and economic considerations are not legitimate.

We might make the argument we ought to have more of them here to protect
our farmers. I mean, I don\'t want to get into that in this debate, but
I would \-- I\'ll write a sentence or I would want to condition the
sentence that \--

MS. DILLEY: And I think you offered a sentence in this side-by-side
compilation that said \--

DR. MELLON: That says that there are \--

DR. VAN EENENNAAM: I don\'t know about that very last sentence, whether
that\'s wrong or not.

DR. LAYTON: Recommendation. And we shouldn\'t have recommendations we
decided.

DR. DYKES: I don\'t think the last sentence is a recommendation, Pat.

DR. LAYTON: It not? Okay. I just want to hear.

DR. DYKES: I think it\'s a statement. The ability of the USDA to address
these is going to have an impact.

DR. LAYTON: Okay.

MS. DILLEY: Just take it out of italics.

DR. DYKES: I think it\'s especially true as we see the reduced direct
farm payments in the trade talks. These things are only going to
escalate. They\'re going to become more important.

DR. LAYTON: Randy.

MR. GIROUX: I\'m going to disagree with one of the statements made in
the text. I thought it was going to read but it\'s not, and that is that
these moratoria have a disincentive on the development of new varieties.
And I\'m going back to the tech companies on this, but you know, I
continue to manage one or more biotech events in the marketplace. Every
year there\'s at least three new events on the market. There\'s new
events on the market in Argentina.

So, I\'m sure it may have impacts on commercialization, but I\'m
struggling to believe that there\'s a disincentive on the development of
new transgenic crops when they continue to be commercialized in the
market. So, I\'m struggling with that one.

DR. DYKES: Maybe it should be commercialization.

DR. SHURDUT: And that was going to be my point is that the development
piece that I have a problem with. I mean, you look at the pipeline,
it\'s as robust as ever. It\'s the launching of the commercialization
which is where the focus.

DR. DYKES: That\'s more accurate.

DR. LAYTON: Okay. Better.

MR. GIROUX: Is it a disincentive or is it a challenge?

DR. SHURDUT: It\'s use of delays and more a cost challenge.

MS. SULTON: Which word?

MR. JAFFE: More of a challenge, I think. It\'s a challenge.

DR. LAYTON: Challenge?

MR. JAFFE: I think the data shows that there is a lot of development
going on.

MR. GRANT: Disincentive is a stronger word and from my observation it\'s
awfully difficult to get a tech company to come forward with a new
product when there\'s \-- you know \-- when it\'s unlikely to be able to
commercialize. I mean, that\'s a disincentive. That\'s not a challenge
if you can\'t even get over the hurdle.

DR. LAYTON: Disincentive. So, go back to disincentive?

MR. GRANT: Yeah. When you get done, Cindy, what did we change in the
issue statement?

DR. VAN EENENNAAM: We didn\'t change anything other than we\'re removing
the second line or the second sentence.

MR. OLSON: It was the second line down.

MR. CORZINE: Is it going down or is it off?

DR. VAN EENENNAAM: It basically got moved. It was talking about
socioeconomic. It got moved to the bottom and some people this and some
people that.

DR. SCHECHTMAN: There was some question about whether the other part of
the discussion about \-- never mind, it\'s in the text.

DR. DYKES: Could you read it back?

DR. LAYTON: Where do you want to read?

DR. SCHECHTMAN: I\'ll read the whole thing.

DR. DYKES: We got it now.

DR. SCHECHTMAN: Other governments\' moratoria on allowing the entry of
new transgenic crops or *de facto* moratoria on reaching decisions on
such crops are limiting the ability of the United States to sell those
transgenic crops and other commingled varieties.

Market access for transgenic varieties and derived products that have
completed U.S. regulatory review is required for those goods to reach a
broad cross-section of users, including consumers. However, some
governments, such as those in the European Union, have effectively
prevented trade in some products through *de facto* moratoria on
approvals of particular transgenic varieties.

Such moratoria can affect not only the import or growing of grain but
also the range of grain-derived food and feed ingredients and how
they\'re used. The existence of such moratoria is a disincentive for the
commercialization of new varieties and even for trade with some other
nations without moratoria.

Some members believe that the incorporation of political or
socioeconomic criteria into some nations\' regulatory evaluation
processes, as has been done in Argentina and South Africa, are factors
that could also inhibit the development and deployment of potentially
useful new crops.

Other members see no evidence that socioeconomic considerations within
the regulatory process have prevented, that should be, prevented a
transgenic crop from being commercialized and believe that there are
ways that those issues can be addressed by the government \-- those
governments, or, I\'m not sure.

MR. JAFFE: Those governments.

DR. SCHECHTMAN: Those governments without impacting trade from the
United States. The ability of the USDA to address all these barriers for
transgenic crops and derived products will directly impact trade,
technology advancement, and diffusion.

MS. DILLEY: You haven\'t added the sovereignty point and we haven\'t \--
I\'m not sure we\'ve addressed

Randy\'s \--

DR. DYKES: I would add one.

MS. DILLEY: It has been addressed. Okay.

DR. DYKES: Up where we say commercialization of new varieties, that
should be commercialization of new events.

MR. JAFFE: Be more accurate.

DR. DYKES: Be more accurate, I think. I\'m fine with it either way.

MS. DILLEY: Mardi, do you see up there where we could add the point of
sovereignty because we don\'t have that up there?

DR. MELLON: It needs to be done in Greg\'s sentence.

MR. JAFFE: No.

MS. DILLEY: No, we\'re done with Greg. Other members, I believe.

DR. MELLON: And other new varieties, that sentence.

DR. SCHECHTMAN: Next.

DR. MELLON: That\'s it.

DR. CRAMER: That\'s the only place.

DR. LAYTON: Where was the variety, Michael?

UNIDENTIFIED MALE: We changed variety.

MS. DILLEY: No, we\'re on 25.

DR. DYKES: Where we changed development to commercialization, it\'s two
words later. It\'s commercialization of new.

MS. DILLEY: New varieties. So, you want \--

DR. SCHECHTMAN: Just before the some.

DR. VAN EENENNAAM: New events.

MS. DILLEY: New events. Disincentive and commercialization of new
events, is that what you want?

DR. LAYTON: Commercialized events?

MR. CORZINE: Is it commercialized events?

DR. VAN EENENNAAM: Down further.

MR. JAFFE: Both.

DR. DYKES: Varieties containing events. He doesn\'t have any problem
commercializing varieties because of this. You can\'t commercialize new
varieties with events, transgenic events.

DR. LAYTON: Okay. So, should it be new varieties containing, or,
varieties containing new events? New events.

MS. DILLEY: Right now we have Greg\'s language which is other members
see other events as socioeconomic considerations within the regulatory
process have prevented a transgenic crop from being commercialized,
etc., etc.

DR. MELLON: You need to insert right after other members, other members
believe that socioeconomic considerations are legitimate exercises of
sovereign authority and see no evidence that socioeconomic
considerations within regulatory processes have prevented transgenic
crops from being commercialized. Further, they believe.

MR. JAFFE: I\'m not sure I agree with that \--

MS. DILLEY: Okay. Well, then we need a different sentence than
sovereignty.

MR. JAFFE: \-- where you put your sentence in.

MS. DILLEY: That\'s fine.

MR. GRANT: Third group.

DR. MELLON: Don\'t you agree that these are legitimate exercises of
sovereign authority, to condition regulatory approvals on socio-economic
considerations?

MR. JAFFE: There\'s the WTO. A lot of countries have agreed to that and
they\'ve given up some of that, so, I mean, I think it\'s more complex.

DR. MELLON: Well, I do think it\'s complex, but I\'m just \--

MR. JAFFE: I think there are only certain socioeconomic considerations
that are appropriate under the SPS and under the Biotech Protocol, only
there\'s a limited socioeconomic considerations. So, I do agree that
some can be taken into account. I don\'t agree that what some countries
are \-- I mean, this is way off point here, but I mean, there are some
things like, I mean, a lot of countries want to deal with organic,
contamination of organics and the economic impact of that and they
consider that a socioeconomic consideration.

I don\'t think that is. I think that\'s a contract liability tort thing.
It\'s not something that should be taken into the regulatory process,
so, I think there are very different definitions of that.

MS. DILLEY: So, we\'re not going to merge that sentence and the question
is, Mardi, whether you want to add another sentence so others.

DR. SCHECHTMAN: Can you just soften that and say that, you know,
incorporation of some socioeconomic considerations may be a legitimate,
but see \--

MS. DILLEY: And do not see.

DR. LAYTON: I don\'t think that Greg\'s ready to accept it as his
sentence and Mardi needs to come up with another sentence.

DR. MELLON: I will do my own.

MS. DILLEY: Mardi\'s going to do her own.

DR. MELLON: I will just have a sentence that says some people believe
that some economic \-- socioeconomic considerations are legitimate
exercises of sovereign authority, period, and then you can go on if you
want.

MS. DILLEY: Okay. That\'s fine. Did you get that, Cindy?

MS. SULTON: No.

MS. DILLEY: Okay. Can you write that down, Mardi, and give it to Cindy.
Duane?

DR. DYKES: Where does it?

MS. DILLEY: After Greg\'s.

MR. GRANT: With regard to on line 786-787 we talked about grain, but
also a range of grain-derived food and feed ingredients and that\'s too
narrow.

DR. LAYTON: I thought that using the word, for example, there.

MR. GRANT: You could use it. I would suggest you write food and feed
ingredients to replace also the range of grain-derived food and feed.
Just derived food and feed.

MS. DILLEY: Derived food and feed?

MR. GRANT: Yes. A wide range of.

MS. DILLEY: Period?

MR. GRANT: I\'m sorry. Such moratoria can affect not only imports but
the use of a wide range of derived food and feed ingredients.

DR. DYKES: Are you taking out growing of grains?

MR. GRANT: Getting rid of growing.

MS. DILLEY: So, it says such moratoria can affect not only imports but
also a wide range of.

MR. GRANT: In your colorful version, Abby, you\'ve got it in there.

MS. DILLEY: Okay.

MR. GRANT: It\'s actually a longer sentence and I need to flip back over
on my page, but \--

DR. LAYTON: It\'s the use of the word grain, it\'s very limiting.

MR. GRANT: Right. That\'s what I\'m trying to get around.

MS. DILLEY: So we replace that sentence with the sentence in the
colorful version that says such moratoria can affect not only the import
or growing of transgenic varieties but also affect the import and use of
the wider range of derived food and feed ingredients.

MR. GRANT: Yes.

DR. LAYTON: Are you okay with that, Michael?

DR. DYKES: Yeah.

DR. LAYTON: Take Abby\'s sentence.

DR. DYKES: I would just where we changed varieties to events earlier \--

DR. LAYTON: Yeah.

DR. DYKES: \-- I think we should to be consistent in this paragraph that
should say transgenic varieties. Then that way we use the same term
throughout this paragraph.

DR. LAYTON: Hang on a minute. Let her do her thing.

DR. DYKES: Commercialization of new transgenic varieties and then we use
the same terminology throughout the paragraph.

(Discussion off the record)

DR. LAYTON: What\'s our next one, Abby? I know you had a point, but I
just want to make sure we know where we\'re going.

DR. VAN EENENNAAM: I have something that\'s unrelated to this particular
little edit, but the way that it reads now, some members incorporate
socioeconomic and political is the way it read and blah, blah, blah.
Then other members and had just spoken for the socioeconomic and I guess
my question is, do some members think that political doesn\'t have an
effect, or, does everybody think that political factors have an effect
and do you want the political in the ones that do think socioeconomic
and would this all have an effect? Because, almost by definition, a
moratoria has a political effect.

MR. CORZINE: Well, I think Greg brought up a good point about the
political and the need to make that linkage. You know, I do feel the
socioeconomic, but you need the political.

DR. VAN EENENNAAM: Well, the some members, some members kind of makes it
sound like some members think political has an effect, but others
don\'t.

MR. CORZINE: Maybe they don\'t.

DR. VAN EENENNAAM: Well, I don\'t know. I\'m just \-- let me bring out
that point that the way it reads now it kind of looks like some people
don\'t think political has an effect.

DR. DYKES: I thought that the conversation, and I agree with Greg that
what\'s the driver or the other, but I kind of thought we all were the
same category, that political and socioeconomic were together. I\'m not
speaking for Greg, but those of us in that category think so.

MR. JAFFE: Socio and political are okay.

DR. VAN EENENNAAM: But on 963, incorporation of political and
socioeconomic nations\' regulatory.

DR. DYKES: Well, I thought Greg was going to articulate it.

MR. JAFFE: No.

DR. LAYTON: She wants to know if you need to add the word political and
socio.

DR. DYKES: But Greg doesn\'t believe political and socio, he believes
socio-economic.

MS. DILLEY: Just specific to socioeconomic. We asked that question.

DR. DYKES: Well, we\'re not going to challenge the sovereignty belief
here, folks.

MS. DILLEY: I think it\'s correct the way it is. I mean, it may read a
little funny but it\'s correct the way it is. Did you have another
question, Alison?

MR. JAFFE: And I think it\'s bad to put the political in there when you
then give the examples. Personally, Argentina and South Africa, I think,
but that\'s not my side. If you want to write that, that\'s fine, but
I\'m not going to respond to that in my text. If that\'s what the
question is, then it gets too complicated to the point that I want to
make.

I think that that point is not \-- well, I think adding political in
that sentence mucks up the point, to be honest with you. That was the
point I wanted to make. And I think especially when you put in as done
in Argentina and South Africa. But if they want to do that, I\'m a firm
believer of each side should write what they want.

MS. DILLEY: Any other questions, Alison?

DR. VAN EENENNAAM: Well, it\'s not really a question. It\'s just a point
that, although Carol didn\'t get her comments in on this one on time,
she does have in her thing that she\'s vehemently opposed to this as was
written and doesn\'t like the final sentence. And I guess I \-- you know
\-- there\'s about 20 people sitting here and one person that doesn\'t
agree with, I know just from what she wrote, that is not going to be
happy with that inclusion of that last sentence and I just wanted to
bring that point up.

DR. DYKES: Can I address that?

MS. DILLEY: Yes.

DR. DYKES: My view of the time we spent on it, we already had this one
some members and other members. My suggestion is she should put in
whatever sentence she wants as other members. That would just be my
thoughts.

DR. SCHECHTMAN: Her issue was with the last sentence. It was just the
last sentence that the ability of USDA to address it, which is not a
some or some.

DR. DYKES: Could be, Michael. Some believe the USDA\'s ability and
others don\'t think USDA should.

DR. SCHECHTMAN: Okay.

DR. LAYTON: Okay. We\'ll deal with her objection to the last sentence at
the end. Thank you for bringing up Carol\'s opinions in her absence.
We\'ll let her know about it.

DR. VAN EENENNAAM: We\'re watching out in the interest of fairness.

DR. LAYTON: In the interest of fairness. Cindy, are you up with us?

MS. DILLEY: We can\'t do without Carol here, I think. That\'s the
question, guys. Some people think that looks like recommendation
language, Carol in her comments, and others think that it\'s not a
recommendation, that it\'s just something that USDA needs to be aware of
that and address. There\'s no particular how to do it, etc. It\'s just,
I think, from some people\'s perspective it\'s just saying that USDA
needs to address it, but there\'s no \-- it doesn\'t go further than
that.

So, people are going to keep it in and we can\'t completely resolve that
until Carol\'s here because she made the comment about reading it as a
recommendation.

DR. LAYTON: Let\'s let Carol look at what we have now that we\'ve done
what we\'ve done to it and see what she thinks when she gets here.

MR. CORZINE: The only problem is that we\'ve got everybody else here
that\'s done it and we\'ve all had the spirit of compromise and Carol\'s
missed all that discussion so I don\'t know what \-- I think we should
close it and move on.

DR. LAYTON: You want to move on?

MR. CORZINE: Yeah.

DR. LAYTON: Okay.

MR. JAFFE: Well, if we just \-- I mean, would there be a way just to get
rid of the ability of USDA and just saying addressing all these barriers
so it\'s more of a generic statement so it\'s not a charge of USDA and,
in fact, USDA doesn\'t for a lot of these regulatory things impact other
parts of the U.S. Government.

MS. DILLEY: So addressing all these areas?

MR. JAFFE: There\'s a trade representative and a host of things and
that\'s a more generic statement that\'s less of a recommendation and
might satisfy Carol.

DR. LAYTON: Okay. The ability to address all these barriers for
transgenic crops and derived products will directly impact trade,
technology advancement, diffusion?

MR. JAFFE: Right.

DR. LAYTON: Drop of USDA?

MR. JAFFE: The ability of USDA.

MS. DILLEY: So, it just says addressing all these barriers, blah, blah.

MR. JAFFE: Right.

MS. DILLEY: Okay. Addressing these barriers? Addressing these barriers
for transgenic crops and derived products will directly impact trade,
technology advancement, and diffusion, period.

DR. LAYTON: Okay. Period. I hear you.

MS. DILLEY: Addressing such barriers. Okay. Mardi, I\'m not sure we got
your language though.

DR. MELLON: You did.

MS. DILLEY: We did. Okay, so, are we ready to close this out?

MR. GRANT: What was Mardi\'s language?

MS. DILLEY: Some members believe that social and economic conditions on
regulatory decisions are a legitimate exercise \--

DR. LAYTON: Are a legitimate exercise of sovereign authority.

MS. DILLEY: Are a legitimate exercise of sovereign authority. Okay. So,
are we ready to finalize that one?

DR. DYKES: I don\'t know what that sentence means though. What does it
mean that socioeconomic conditions on regulatory decisions?

DR. LAYTON: And or on regulatory decisions?

MS. DILLEY: Consideration within the regulatory process.

DR. MELLON: Maybe conditioning regulatory decisions on social and
economic considerations.

DR. LAYTON: Conditioning regulatory decisions on social and \--

DR. MELLON: Social and economic.

DR. LAYTON: \-- economic conditions are legitimate considerations, are a
legitimate exercises of sovereign authority.

DR. DYKES: I\'m not where Mardi, Jerry, and Greg are, I guess. I\'m not
there. I just don\'t agree with what\'s written.

MS. DILLEY: Okay.

DR. LAYTON: Some members believe that conditioning regulatory decisions
on social and economic considerations \--

MS. DILLEY: Considerations instead of conditions.

DR. SCHECHTMAN: Leave social and economic. Just get rid of conditions.

DR. LAYTON: Considerations and then delete \--

MS. DILLEY: Then go to are.

DR. SCHECHTMAN: Get rid of are. Is a \--

MS. DILLEY: Is a \--

DR. VAN EENENNAAM: Is a legitimate exercise.

DR. SCHECHTMAN: Is a legitimate exercise.

MS. DILLEY: Okay. Period. Okay.

DR. LAYTON: Okay.

MS. DILLEY: Great. I would suggest we take a break for ten minutes and
then the next topic we can address is \-- should we do 26? 26 is state
and local established moratoria. It\'s right after 25.

(Whereupon, a brief recess was taken)

DR. LAYTON: Okay. Let\'s do 27.

MS. DILLEY: So, if you can take your seats we\'ll get started. I think
we neglected to mention that Carol is absent for personal reasons.
We\'re glad she\'s back. She\'s had a chance to look at the number 22
and we\'re putting that to rest. She\'s comfortable with the changes so
we\'re all set with that. I don\'t know if you\'re redoing 25. I think
you\'ll be comfortable with it.

MS. TUCKER FOREMAN: I think I\'m fine with it. Let\'s not hold up time.
I apologize for being late. I had a death of a close friend and I had to
take people to the airport.

MS. DILLEY: So, we had talked about picking up 27 and that\'s where we
thought we would start. I don\'t know if people had a chance to review
it. This is protection of intellectual property and on the colorful
draft, it\'s page 18. On the one that was distributed yesterday, version
for editing, it\'s on page 25.

In the colorful draft there\'s only one edit in the last sentence,
removing greatly, and then Mardi had a comment and I talked to her about
whether she was looking for alternative language or just was making kind
of a side comment or what we need to do.

So, we\'ll pick up. You can see her original comment in the compilation
document, but obviously she\'s here. We have her in person so she can
make comments on topic 27, which is intellectual property. So, take a
minute and we\'ll review that one and then we\'ll start conversation.

Greg?

MR. JAFFE: I have one proposal which is to delete the reference to
humanitarian on whatever line that is in whichever draft.

MS. DILLEY: On 25. And since we\'re picking up humanitarian or what?
Which one?

MR. JAFFE: Well, I don\'t think that references

\-- I don\'t understand the reference and I think it\'s not correct.

MS. DILLEY: Okay. What line is it? I\'m sorry.

MR. JAFFE: Line 831.

MS. DILLEY: 831, okay. So, e.g. part, delete the parenthetical.

MR. JAFFE: Right. I don\'t understand \--

DR. LAYTON: Okay.

MS. DILLEY: Okay.

MR. JAFFE: \-- how that fits into that statement that\'s being made. It
somehow seems to suggest that humanitarian uses wouldn\'t get IP
protection that other uses would get in those countries or something. It
seems very strange.

DR. LAYTON: Right. I think you\'re right. I agree.

MS. DILLEY: Okay.

DR. LAYTON: Is everyone comfortable with deleting the word greatly in
that next to the last line beginning at 831? Okay. Moving on. Greg, your
sign is down again now?

MR. JAFFE: Oh, no, it\'s down.

DR. VAN EENENNAAM: We\'re done?

DR. LAYTON: Done.

DR. SCHECHTMAN: I know this is a topic that Russ may want to say
something about so we can put it aside for a moment. I mentioned it to
him. He was on the phone so I just wanted to be sure. We\'ll give him a
second when he gets back in.

DR. LAYTON: Well, while we wait, Abby, which topic do you want to pick
up next?

MS. DILLEY: 28. We were on 27. We\'ll table it for now, humanitarian use
licenses.

DR. LAYTON: Okay. Okay.

MS. DILLEY: And that\'s on 28.

DR. MELLON: What bothers me about this one is the notion that somehow
the U.S. has these obligations to the world\'s poorest people that would
lead us to want to go to a lot of trouble to make these very expensive
biotech products available and that we\'ve run into the \-- the problem
of patents, of course, makes that difficult because no one \-- because
there are too many patents on any individual product and it\'s very
difficult to negotiate around those.

But I really think that that \-- like I said, this is my comment that it
misses the point. I mean, I think the problem is that biotech is a very,
very expensive technology with very limited uses and that if we really
want to use the very limited money that the U.S. has available in any
setting to help the world\'s poorest countries, and we make very little
money available for those processes, it would be better for us to spend
it on \-- not on this limited set of very expensive products, but on
much more \-- on much cheaper agricultural technologies that we could
hopefully provide outside of the kind of complexity of the patent
system.

So, I\'d like \-- and, I mean, I think that would be a much \-- if we
really cared about the poor people rather than the technology or
advancing it I think that we would \-- this would not be the first thing
we\'d do.

And I\'d rather \-- and I would like to suggest that we add the text
that I provided in the side-by-side as, you know, perhaps as a some
committee members believe, but that the high cost of patented products
and the unwillingness of patent holders to negotiate humanitarian
licenses argue that the USDA should champion cheaper, more effective
approaches of improving crops in developing countries. Publicly funded
agricultural research using non-patented traditionally bred crops is an
option that should be considered.

MS. DILLEY: So that that last paragraph in the side-by-side comments and
it may read some members believe the high cost of, and then it goes on
from there. But that\'s the question. And you\'re suggesting that text
be added to \--

DR. MELLON: I\'m suggesting that that would be added to the humanitarian
licenses. It just strikes me as bizarre that that would be our \-- what
we would be providing to the world\'s really, really poor when
traditional breeding can do so, so, so much and need not can be, but
need not be patented.

MS. DILLEY: Michael and then Pat.

DR. DYKES: This probably doesn\'t get to your issue, Mardi, but maybe
one of the things we do is if we drop the last sentence about a role for
federal agencies so we\'re not getting into whether the federal agencies
help with IP or whether they help with bringing in things for the poor
because I\'m not totally convinced that the federal agencies \-- I\'m
not clear what that last one means in my mind.

So, I would suggest dropping the last sentence.

MS. DILLEY: So, deleting the last sentence. I don\'t think that that\'s
to Mardi\'s \--

DR. DYKES: I don\'t know if that totally addresses \-- makes Mardi feel
any better as to where she\'s coming from or not.

MR. CORZINE: The one in italics?

DR. DYKES: Yes.

MS. DILLEY: I think \-- I mean, it may be that if some members think
assuring the availability of such licenses, etc. to continue with the
thought process and then I think Mardi\'s language is more some members
believe the high cost of \-- I mean, it\'s just kind of a different
framing of the issue from what I understand you saying. But maybe that
results in a some members, others. I don\'t know.

Leon?

MR. CORZINE: I\'d just like maybe a little clarity, if I could, Mardi,
because it\'s saying one thing here that in one sense that our tech
providers or the U.S. should make the biotech products more readily
available to the poorer countries, but then, on the other you\'re
saying, no, make the conventional breeding more available. Which way is
it, I guess is my question?

DR. MELLON: Until the tech products are broader in application and much,
much, much cheaper I just \-- I think that \-- I mean, I would say that
we should do both. I mean, if we could, we would provide some of the
appropriate biotech products to the poor countries, but pointing out how
difficult that is because of the real world consequences of patents.

So, they should do it, but I don\'t want to leave the implication that
that\'s all they can do when, in fact, I think, you know, there is
another way to go where you could really make a big difference for a lot
of poor countries that would avoid all of this. It wasn\'t that I don\'t
think that they ought to be provided. They should be. But it\'s proven,
you know, talk to the folks who tried to negotiate the 85 patents that
are on the vitamin A rice. It\'s an absolute nightmare.

I would rather see that money go into providing the already available
traditionally bred iron-dense rice that could \-- you know \-- making
that available. That would be a better use of money to me.

MR. CORZINE: If I could. So, the other part of the issue from our
perspective, the U.S. farmer, we have said that we don\'t mind paying
our share of what development costs are, technology fees, but we don\'t
think U.S. farmers, for example, should pay them and the rest of the
world gets a pass. Wherever they\'re used, everybody should be paying
their fair share, whatever that cost is.

And you can argue whether it\'s too high, too low. If it\'s too high
it\'s very simple, don\'t buy it, you know. But the U.S. farmer hasn\'t
said that. So, but that is the issue that we want to make sure there is
a place for intellectual property rights in agriculture just like there
is in the pharmaceutical industry and everywhere else.

So, that\'s the issue that we have to be careful in and, you know, where
do you draw the line on humanitarian or helping out the lesser or least
developed countries, or, you know, it kind of gets to what\'s a
disaster, what\'s not a disaster. So, that\'s an issue that we have to
stay aware of.

DR. MELLON: And I agree that both of them are there and, I mean, one of
the things I tried to point out is that the patent, the ag patent issues
are going to be embedded in these larger patent issues that are rising
in the context of drugs. And I agree, I understand completely what
you\'re saying and I think it\'s a real issue that people need to
confront, but they are insisting and succeeding in providing patented
drugs at low cost to needy people around the world in some situations
and pressure in that direction is going to continue.

I just think that that context will influence and I don\'t \-- you know
\-- I don\'t quite know how, but will influence this debate about
agriculture, especially when you\'re considering very poor people. But
as I said, I agree with you. I think it\'s out there. It\'s a problem.
It\'s a huge issue.

MR. CORZINE: So, my question is, not to belabor this, in conventional
breeding, things that aren\'t patented, there isn\'t anything stopping
that now?

DR. MELLON: No, there isn\'t anything stopping it except that all the
resources are going \-- I mean, we\'re talking about the amount of
resources that are going to pushing and providing those kinds of
technologies through international research organizations of some sort
and the fact is that the U.S. isn\'t using its \-- I mean, it\'s using a
lot of its resources as we know to promote biotech around the world.

It is not using anywhere like those resources to push traditional
breeding, to make it available, to facilitate \--

MS. DILLEY: I don\'t think you guys are disagreeing. I think that
you\'re looking for more articulation of the broader picture because I
don\'t think \--

MR. CORZINE: Right.

MS. DILLEY: \-- there\'s disagreement. It\'s just the way it\'s written
from Mardi\'s perspective is that it gears it more towards that\'s the
answer and putting resources towards the patent issue and humanitarian
licenses whereas there\'s a whole range of things.

Her priority would be to put resources elsewhere, but you know, this is
one issue. It\'s just the way it\'s written from her perspective it
needs additional language to present that context.

So, I don\'t know if you have any additional language.

MR. CORZINE: That is if we do that we want to recognize, you know,
really there isn\'t anything blocking that from happening now.

MS. DILLEY: Right.

DR. MELLON: We\'re talking about promoting humanitarian.

MS. DILLEY: But you add that context within the context of a range of
avenues for providing assistance, blah, blah, blah. I don\'t know. That
may not be the right answer, but \--

DR. MELLON: Yes, but I\'d like to \-- you know, in my world I\'d like to
see these others given the same kind of \-- you know \-- to be pushed
with the same energy and the same backing of the Federal Government as
now goes into pushing biotechnology.

MS. DILLEY: Okay. So, let me pick up Pat, Duane, and then Carole Cramer.

DR. LAYTON: This is Bob Herdt\'s issue so I\'m going to sort of remember
what he said which was, I don\'t think he said anything that you didn\'t
say already. I just assumed \-- I think Bob assumed that we were going
to do everything else to be also, but in special cases that it would
really help some of the poorest nations if they had availability to some
of the future transgenic crops.

And, so, in those cases where it would be helpful and it couldn\'t be
done any other way to help with the humanitarian use patent and this is
based on both, you know, the comments from the guy from Purdue, whose
name I can\'t remember, but who\'s now got some new job at Purdue.

DR. SCHECHTMAN: Randy Woodson.

DR. LAYTON: Randy. He\'s got a promotion, by the way. And that, you
know, I thought he was pushing for those cases where a transgenic
variety or crop was important in the very poorest countries that this
was something that needed to be taken care of. I don\'t think ever that
he intended for this to not follow on top of every aid that were true,
of traditional uses.

And I don\'t know if you can qualify it \--

MS. DILLEY: And use that clarifying language in the \-- maybe you can
find that language in there to do that.

DR. LAYTON: When absolutely necessary for humanitarian uses or
something. I don\'t know. But I don\'t think he intended it to play one
against the other. I thought it was strictly for if it was needed then
we should \-- then you need to have a way to get around the patents or
get to deal with patents.

DR. MELLON: Well, I agree with that. I mean, I don\'t even think you
even need to go as far as to say if it\'s absolutely the only way. I\'m
just saying the reality right now is that the available products to
whatever, the African country, there are very few and, yet, there\'s a
whole book called \"Lost Crops of Africa\", you know, that lists
literally thousands of crops that could benefit from modern, traditional
breeding technology, or, I mean, all kinds of other things for which
there are no resources.

And, so, I just want \-- I mean, I don\'t want to \-- like I said, I
don\'t even think you have to say you would never turn to biotech until
the very end. But right now, if you want to help the poor, hungry people
this is about tenth of the list of the things that you could do that
would help people eat and I want at least some of that context to be in
there.

You know, it\'s not that people are waiting for these new biotech
products and until they come they\'re not going to be able to solve
their problems.

DR. LAYTON: But is that an issue germane to the topic of this committee?

DR. MELLON: I think the context is important for people to address with
this technology in some sort of context. Otherwise, it does leave the
implication that this is the technology that will feed the world. While
that had some currency for a while, no one says that anymore, and I
think that we should leave that implication.

DR. LAYTON: How about in addition to other aid \-- in addition to
traditional aid as a starting point future transgenic \-- you know \--
in addition to traditional aid on crops or varieties, future transgenic
crop and animals varieties are likely to involve \-- I mean some way or
another.

Okay. In addition to available technologies, assuring the availability
of such licenses \-- humanitarian licenses is a complex process.

DR. SCHECHTMAN: No complex. Will be critical.

DR. LAYTON: No complex. Will be critical.

MS. DILLEY: You\'ve got the language up there. Okay. Pat, do you want to
take another run at it again?

DR. LAYTON: Michael had me \-- was helping me.

DR. SCHECHTMAN: In addition to \--

DR. LAYTON: Traditional.

DR. SCHECHTMAN: \-- traditional technologies, or, however you want to
put that, comma, assuring that \-- after such licenses put a comma \--
though complex, will be \-- I don\'t know that traditional technologies
is the word that you want there.

MS. DILLEY: We\'re trying to add the context, Mardi, in that second \--

DR. SCHECHTMAN: Such to humanitarian in the \-- down a line to the left.
Such licenses.

DR. LAYTON: 1037.

DR. SCHECHTMAN: Yes.

DR. MELLON: I don\'t think it\'s critical at all. I think it is useful
in helping \--

DR. LAYTON: Okay.

DR. MELLON: \-- people meet responsibilities.

DR. LAYTON: Are you comfortable?

DR. MELLON: I think that plus the additional language that I suggested
would be fine.

DR. LAYTON: And we\'re saying does this cover it? In addition to the
availability \-- in addition to traditional technologies.

DR. MELLON: Where is that?

MS. DILLEY: I think what we\'re trying to do is find a unified sentence.
I\'m not sure we can. So, let\'s \--

DR. LAYTON: We don\'t have to do some members.

MS. DILLEY: So, you\'re looking for additional language to provide that
context and I don\'t think that traditional technologies, from what I\'m
hearing Mardi saying is \--

DR. MELLON: I would prefer my \-- I would prefer having the additional
language that does, you know, make it clear that these \-- you know \--
that the USDA should at least consider championing the cheaper, more
effective approaches.

DR. VAN EENENNAAM: How about in addition to \--

DR. LAYTON: Traditionally bred crops?

DR. VAN EENENNAAM: \-- traditionally \-- no. In addition to publicly
funded ag research using traditionally bred crops.

DR. MELLON: In addition to?

DR. VAN EENENNAAM: Right.

DR. CRAMER: I think this is a very simple topic and I think that you\'re
actually trying to put stuff into something that doesn\'t \--

DR. LAYTON: Doesn\'t need to be in?

DR. CRAMER: \-- need to be here. I think that this is just a very small
thing that we want the Secretary to be aware that facilitating
humanitarian use licenses have a place in looking at the future of
agriculture.

And I think that this isn\'t the place to sort of look at the broader
context of where we\'re putting our aid. I think this is making a very
simple statement. It follows on the previous intellectual property and
it\'s just saying that there\'s going to be an issue. I think we should
keep this simple. I think it\'s fine to say it the way that we did
there, but I don\'t think this is the place to make recommendations as
to where we\'re putting our aid dollars.

I think it\'s trying to mix apples and oranges.

MS. ZANNONI: Mardi, would it help if we took out that sentence, what we
have the last sentence now, just take it out?

DR. SCHECHTMAN: Which one?

MS. ZANNONI: Assuring the availability of such licenses, a complex
process, and be critical \-- because, to me, I think I kind of agree to
some extent with Mardi. It looks like this is the thing that the U.S.
has to do. So, if that was just taken out and make it \--

DR. DYKES: So maybe just kill the last two there and you stop it after
specific country and use.

MS. ZANNONI: Would that help?

MS. TUCKER FOREMAN: If you cut that.

DR. MELLON: I\'m comfortable with that.

MS. DILLEY: You can go with it. Okay, let\'s do it.

DR. LAYTON: Let it go.

DR. VAN EENENNAAM: Oh, I just had an edit that was incorporated in the
colorful version that I think clarifies. There\'s a sentence up there
that I didn\'t really get what it meant. I don\'t know if we want to
adopt the incorporated here, but basically it replaces the second as
well as \-- about the effectiveness of \--

DR. LAYTON: At least in part the concerns about the effectiveness of \--
\-- restrictions that might be attached to the license to limit the use
of the technology of a specific country and use.

DR. VAN EENENNAAM: And I just had suggested that \-- I think what
companies are concerned about is the subsequent unlicensed use of their
technology for other unauthorized applications. And that wasn\'t clear
to me in that sentence.

DR. LAYTON: Greg, is it on that?

MR. JAFFE: Yeah, it is. I was going to propose deleting that whole
remaining clause from where it says at least in part because I don\'t
\-- I\'m uncomfortable with that portion of the text because I think
there are a lot of reasons why IP holders might not provide their
humanitarian licenses. My understanding of the decisions by companies,
universities, and governments is it\'s very complex and it involves many
different reasons and I think we\'re putting undue influence on one
particular reason here and I don\'t think that\'s justified.

So, my suggestion was to \-- I mean, before we get to Alison\'s point,
my suggestion is just to delete that because \--

MS. DILLEY: Is there anything left to that sentence?

MR. JAFFE: \-- I don\'t know why we\'re putting emphasis on this
particular one that says whether it\'s going to be used effectively. I
mean, there\'s lots of reasons why. I mean, I talk to people and they
say the first reason they don\'t want to give you a humanitarian license
is because there\'s no regulatory system so they\'re worried about
liability from the safety.

They don\'t say it\'s because they\'re worried that you might think
somebody\'s going to go broader than the humanitarian license provision.
So, I think we\'re just putting the wrong emphasis.

MS. DILLEY: Okay. So, is there anything left in that sentence at all
then if you delete that?

DR. DYKES: Humanitarian use licenses vary.

MR. JAFFE: Right. Period. Vary.

DR. LAYTON: The reasons for them.

MS. DILLEY: So, you want the priorities and attitude that IP holders or
is that not what we have now?

MR. JAFFE: Good.

DR. LAYTON: That\'s it.

DR. DYKES: Humanitarian license varies.

MS. DILLEY: Period.

MR. JAFFE: There\'s one small other little edit and that is in the topic
sentence, the second sentence, just to me, likely sometimes to be
difficult. But that\'s just totally \-- so I think it should say
sometimes difficult \-- it\'s sometimes difficult to achieve. So,
sometimes difficult to achieve because likely sometimes to be difficult.

DR. MELLON: Has any humanitarian use license ever been issued? I mean,
is this a theoretical construct or \--

MS. DILLEY: I don\'t know. Bob isn\'t here.

DR. LAYTON: I don\'t know. Bob isn\'t here.

DR. MELLON: The rice?

DR. DYKES: Vitamin A.

DR. MELLON: Is it rice? The golden rice? That wasn\'t one of the 18
companies said that they wouldn\'t try to \-- but it\'s not a
humanitarian \-- But I mean is there such a thing?

MR. JAFFE: What, a humanitarian use license?

DR. MELLON: Yeah.

MS. DILLEY: Michael\'s saying yes.

DR. DYKES: A transgenic.

DR. MELLON: Well, I\'m just not aware of one that, you know, we might
want to make it clear to the Secretary that these are something they
might be issued but that they really haven\'t.

DR. LAYTON: That\'s what that first sentence is, it says future.

DR. DYKES: But I think they have, Mardi.

DR. MELLON: You think they have?

DR. DYKES: Yeah.

MS. DILLEY: Yes. So, the question is, they\'re there and they have been
used? Just for clarification.

DR. DYKES: I think there have been several of them.

MS. DILLEY: Are there any more edits that read there for this one?

DR. LAYTON: Greg?

MR. JAFFE: I\'m done.

DR. LAYTON: Okay.

MS. DILLEY: Are we there? Mardi, did you have any other comments?

DR. MELLON: No.

MS. DILLEY: Okay. We finished with 28?

DR. DYKES: So, we corrected it to say sometimes difficult to achieve and
it stops with license vary? Okay.

MS. DILLEY: Okay. So, let\'s go back to 27. It has been modified to
delete greatly and e.g., humanitarian. So, that\'s what\'s out of it now
and wanted to see if there was any additional comments before we close
and move on.

Okay. Are we finished with that one? Let me make sure that you\'ve had a
chance to read it. All right. We\'re moving on to 26 then. 26. You need
a minute to look it over? And that\'s on page \--

DR. LAYTON: 24 on the version for editing for January plenary.

DR. VAN EENENNAAM: 18 on the colorful version.

DR. LAYTON: 18 on the colorful version.

MR. JAFFE: And I had a number of comments that are on my version.

MS. DILLEY: Okay. So, you have to get at least four or five documents in
front of you to check on this one. Everybody take a deep breath, review
five documents, and I\'ll sit down in a minute. Get in touch with your
inner sense of humor and collaborative nature.

DR. LAYTON: Can we agree to the topic sentence?

MS. DILLEY: Do people want a little bit more time or are we ready to get
going on this one? I heard a nod. Okay. How about 15 more seconds. All
right. Alison and then Greg.

DR. VAN EENENNAAM: I just had a question that I wrote out. I don\'t know
if this has ever been to the state level and I look to the committee to
tell me whether it has or not.

MS. DILLEY: Outwards to establish moratoria.

DR. VAN EENENNAAM: I know it\'s happened in a lot of counties, but I
guess my question is about whether it\'s happened in the states.

DR. DYKES: It\'s been on the ballot.

DR. VAN EENENNAAM: Okay.

MS. DILLEY: Greg.

MR. JAFFE: I have comments on the \-- I have several editing changes to
the topic sentence. First, I think that it\'s more accurate to say at
the beginning public ballot initiatives at the state or local level in
the United States to establish moratoria on the use of transgenic crops
because state or local efforts, I don\'t know, it\'s ambiguous to me as
to what that means, especially the second half. You talk about state and
local regulations. So \--

DR. LAYTON: Okay. So, public ballot.

MR. JAFFE: Public ballot initiatives at the state and/or local level.

MR. GRANT: Greg, my only question there would be is that completely
accurate? I believe there have been other initiatives that have not been
public ballot initiatives that are proposed by county commissioners, for
example.

MR. JAFFE: Well, it says or to put in place state or local regulations
so I think those are covered. I mean, local commissioners, they\'re
elected people, they\'re legislative bodies that are putting in place. I
mean, there are two ways something gets enacted in law. You either have
public ballot initiative or you have a legislature. I think the second
one is covered and that\'s why I couldn\'t understand what their efforts
were.

DR. SCHECHTMAN: The way it\'s written, Greg, it sounds like the
initiatives are also to put in place those state or local regulations.

MR. JAFFE: What?

MS. DILLEY: The public ballot initiatives are qualifying the \--

DR. SCHECHTMAN: State or local regulations.

MR. JAFFE: No. It says to establish moratoria.

DR. SCHECHTMAN: Or to put in place.

MR. JAFFE: Oh.

DR. DYKES: I think we can blend the two. I\'m more where Greg is and
it\'s both things. There have been public initiatives. There have also
been the legislative action. So, somehow we need to capture both in the
sentence.

DR. LAYTON: Okay. What if we say public ballot initiatives and
legislative efforts at the state and local level and I don\'t know if
you can be legislative at the local, but anyway.

BY MAJORITY IN RESPONSE: Yes, you can.

DR. LAYTON: In the United States to establish moratoria on the use of
transgenic crops or to put in place state and/or local regulations \--

MR. JAFFE: Or to regulate transgenic crops.

DR. LAYTON: Or regulate. That\'s a good one.

MS. SULTON: Where does it go, here?

DR. VAN EENENNAAM: No. Or to regulate.

DR. LAYTON: Or to regulate. Drop out to put in place.

MR. GRANT: How about if you go to just establish moratoria or
regulations that are more restrictive.

DR. LAYTON: Okay. Or regulation.

MR. JAFFE: Or regulations. I have a problem with saying restrictive. I
mean, that\'s a very subjective term and I would say there were some
that are not \-- they\'re different. They may or may not be more
restrictive, they may be less restrictive, there are lots of things. I
mean, there a lot of regulations being put in place to do liability.

MS. DILLEY: How about additional then?

DR. SCHECHTMAN: Additional regulations.

MS. DILLEY: Additional regulations.

MR. JAFFE: No, because state and local government doesn\'t food safety.
They may not be additional. They may be just \--

DR. LAYTON: There\'s a difference.

MR. JAFFE: \-- they\'re just different. I was writing regulations \--
what?

MS. ZANNONI: Do you need a qualifier?

MR. JAFFE: I don\'t think you do because you\'re saying regulation of
transgenic crops.

DR. DYKES: Replace restrictive but different.

MS. TUCKER FOREMAN: To regulate transgenic crops.

DR. LAYTON: And just end it. Don\'t have all that federal level stuff?

MR. JAFFE: I was deleting the more restrictive than those at the federal
level and you can include have impact on the use of modern product
biotechnology on American agriculture. I mean, every regulation has
impact so I don\'t have a problem.

MS. DILLEY: So, it\'s taking out anything. Take it out.

DR. DYKES: I think it should be that are different than those at the
federal level. That\'s probably the issue here. I find I agree with
Greg. Restrictive is objective, but they are different. Whether it\'s
good or bad or restrictive or less restrictive or they differ, that\'s
the rub.

MS. DILLEY: Okay. So, how does it read?

MS. TUCKER FOREMAN: Different from those?

DR. DYKES: Different from those at the federal level.

MS. DILLEY: That are different than those at the federal level.
Different from those at the federal level. Okay. So, now it reads public
ballot initiatives and regulations at the state or local level in the
United States to establish moratoria on the use of transgenic crops \--

DR. LAYTON: It\'s not public ballot initiatives and regulations. Public
ballot initiatives and legislative actions.

MS. DILLEY: Okay. Just slow down.

DR. CRAMER: Well, they\'re legislative initiatives. Why don\'t we just
say public ballot or legislative initiatives?

DR. LAYTON: Okay. Public ballot or legislative initiatives.

MS. DILLEY: At the state and local level. State and local level in the
United States to establish moratoria on the use of transgenic crops \--

DR. VAN EENENNAAM: And animals.

MS. DILLEY: And animals. How about transgenic \--

DR. SCHECHTMAN: Transgenic organisms.

MS. DILLEY: Transgenic organisms?

MR. JAFFE: No, because a lot of them are not for products.

MS. TUCKER FOREMAN: Organisms.

MS. DILLEY: Transgenic organisms so keep going.

DR. LAYTON: Take crops out?

MS. DILLEY: Just organisms. Or to regulate \--

MR. JAFFE: Transgenic organisms.

MS. DILLEY: Wait. Moratoria on the use or regulation of? What is it?

MR. JAFFE: No. It\'s not moratoria.

MS. DILLEY: It\'s moratoria to establish \-- I haven\'t got it right
yet.

DR. SCHECHTMAN: No, it\'s or to establish

different \--

DR. MELLON: To establish local regulations.

DR. SCHECHTMAN: To establish state or local regulations that are
different.

(Discussion off the record)

MS. DILLEY: There\'s too many people talking at one time. So, Michael,
if you\'ve got it then \--

DR. SCHECHTMAN: Okay. To establish moratoria on the use of transgenic
organisms or to \--

DR. LAYTON: Ssh! Ssh!

DR. SCHECHTMAN: \-- establish state or local regulations that are
different than those at the federal level. That\'s it.

MR. JAFFE: Yeah. All \-- all federal regulations. All state regulations
are different than federal regulations by definition.

DR. MELLON: Yeah. I think you could stop it right after regulations. And
that\'s the issue is that there are local level moratoria and local and
state regulations, period.

MS. DILLEY: So you take out the clause that are different than \-- take
out only to level, between that and level. Carole?

DR. CRAMER: The point is that the reason that we brought this is the
concept that there will be a patchwork which is a challenge to \--

MS. DILLEY: So, the different needs to be there, is that your point?

DR. CRAMER: \-- commercialization so different \-- in different regions
is really the issue that we want to make.

DR. LAYTON: So, different from those at the federal level or any other
region or that are unique?

DR. CRAMER: Different from each other.

DR. MELLON: Say a patchwork of regulations.

DR. LAYTON: Can lead to a patchwork.

MS. TUCKER FOREMAN: May lead to a patchwork.

MS. DILLEY: Okay. So, may lead to a patchwork of what was it?

DR. VAN EENENNAAM: Of different \--

MS. TUCKER FOREMAN: I think it would be more accurate to say will lead
to differences \-- regulatory differences across the country.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: The reason that patchwork suggests that it is a bad
thing. Differences is a neutral word.

MS. DILLEY: Okay. So we\'ve got different differences.

MS. TUCKER FOREMAN: Yeah, I\'m not sure.

MS. DILLEY: Are we closer to articulating what we mean here?

MS. TUCKER FOREMAN: If that substance is okay I\'m sure we can fix it so
it reads better.

MS. DILLEY: So, now it reads public ballot or legislative initiatives at
the state and/or local level in the United States to establish moratoria
on the use of transgenic organisms or to establish state \-- it\'s still
not right.

DR. LAYTON: Or to regulate and take out to establish state or local. Not
that one.

MS. DILLEY: To establish moratoria or to establish \--

DR. LAYTON: Or to regulate.

MS. DILLEY: Or to regulate. Right. Or to regulate. To establish
moratoria or to regulate transgenic organisms at the state and local
level?

DR. LAYTON: Take out state and/or local regulations now. Period. To
establish moratoria on the use of transgenic organisms or to regulate
different from those \-- different than the federal level \-- different
than \--

MR. JAFFE: You want to say regulate transgenic organisms in a manner
different.

DR. LAYTON: In a manner different.

MR. JAFFE: You have to put transgenic organisms.

MS. TUCKER FOREMAN: You could drop the phrase different from those at
the federal level because I think it\'s understood and then it reads or
to regulate transgenic organisms will lead to regulatory differences
across the country.

DR. SCHECHTMAN: No. Right there. Transgenic organisms right where you
are.

DR. LAYTON: The second time.

MS. TUCKER FOREMAN: We\'ll fix it in a minute. We\'re going to regulate
them. Okay. Yeah.

(Discussion off the record)

MS. ZANNONI: But the issue is the marketing issue, not that \--

DR. SCHECHTMAN: And will complicate the marketing of these products. Is
that the \--

MS. ZANNONI: Yeah, which \--

MR. OLSON: If they pass different laws then it\'s going to be different.
The issue is marketing. It\'s a different regulation.

MS. TUCKER FOREMAN: It may also provide many other things. For instance,
safety. Since the products aren\'t regulated, safety is not regulated at
the federal level. I think we\'re going to have to go to some members
think one thing and some members think another on this one so I\'m not
sure you can try to reach an agreement on that.

DR. LAYTON: Do we agree this has the market in it too?

DR. VAN EENENNAAM: Yes. Yes, it does.

MS. DILLEY: Greg, are you looking for this language?

MR. JAFFE: Well, I agree with Carol and I proposed language in my draft
for some members and other members later in the text but we\'re not
there yet.

DR. LAYTON: But can market go in the topic sentence?

MR. JAFFE: It can go although I think the issue is broader than
marketing of these products. I mean, most of these involve the growing
of them, so, I actually don\'t think it\'s much \-- most of it\'s not
the marketing because most of these moratoria address the fact that you
can\'t plant them. They don\'t affect the food products that Ron\'s
talking about that are actually \-- you know \-- the general food
products that go into the commerce.

DR. LAYTON: It\'s not just planting. It\'s \--

MR. JAFFE: Most of them are involve planting of them. So, anyway, the
original one had impacts on the use of modern biotechnology on
agriculture. That was a broader than just the marketing of these
products.

DR. LAYTON: I would say impacts on the use of these products.

MS. DILLEY: And go back to that statement.

MR. JAFFE: Because the products here refers to organisms. We\'re talking
about the organisms, not the food products.

MS. DILLEY: Okay. So, going back to that, in the topic sentence, if we
can go back to that language.

DR. LAYTON: Complicate the use in marketing of these?

MS. DILLEY: No, not marketing. I thought we took it out.

MR. JAFFE: Will impact and then you can explain below.

MS. DILLEY: Will impact the use of these products. Okay.

DR. LAYTON: Okay. Carole?

DR. CRAMER: I don\'t think we should say moratoria on the use of
transgenic organisms because it\'s the production of transgenic
organisms that we\'re talking about. Basically, if I go to a company
that has this moratorium I can still go to the store and buy a
FlavrSavr^®^ tomato if it\'s available which is basically the use. So,
use seems to be the wrong term.

DR. SHURDUT: Mostly of them are planting.

DR. MELLON: It\'s planting transgenic crops as

the \--

MS. DILLEY: So, do you want to make it technically correct and say
moratoria on planting of transgenic crops and the use of \--

DR. MELLON: Should we deal with the moratoria separately from the
labeling initiative?

DR. LAYTON: But you don\'t plant animals.

DR. SHURDUT: That\'s right.

MS. DILLEY: Good point.

DR. MELLON: I mean, the moratoria are not going to affect marketing.

DR. VAN EENENNAAM: Production?

MR. JAFFE: You can\'t take plant for animals.

DR. MELLON: Yeah, and that\'s why I said the production.

DR. VAN EENENNAAM: Production? Production, I think.

DR. LAYTON: The production of transgenic organisms?

MS. TUCKER FOREMAN: How about production of plant crops or animals?

DR. LAYTON: Production of transgenic organisms.

DR. SCHECHTMAN: Or production of transgenic organisms?

DR. CRAMER: That was my suggestion.

DR. LAYTON: Okay.

MS. DILLEY: Production of transgenic organisms? Is that what you said?

DR. CRAMER: Yeah.

MS. DILLEY: Okay.

DR. LAYTON: Instead of the use of transgenic organisms or production of
transgenic organisms?

DR. SCHECHTMAN: Moratoria on?

DR. LAYTON: She\'s changing that.

MS. TUCKER FOREMAN: That doesn\'t prevent Monsanto from developing the
organism. That just prevents the planting of seed from it, right?

DR. CRAMER: Right.

MS. TUCKER FOREMAN: So, that\'s not \--

DR. MELLON: But you could use it. You could bring tomatoes from
someplace into the county and \--

MS. DILLEY: It\'s the production of or is that incorrect?

MS. TUCKER FOREMAN: No, you can create the transgenic organism. It\'s my
understanding that these things prohibit people from planting the seed.

DR. MELLON: The one problem is that there are a lot of them. The early
ones were really poorly drafted and ended up \--

MS. TUCKER FOREMAN: And we don\'t know what they make.

DR. MELLON: We have no idea. The Oregon one, I would say, was in that
category. So, I mean, we don\'t want to get tied up.

MS. DILLEY: So, what\'s the right language then?

DR. LAYTON: It\'s not prohibiting the development. It is the production.
They can develop whatever they want to and produce it in a specific
county.

DR. MELLON: I think the ones that are on the plate right now that have
legs are the moratoria on the planting of transgenic crops.

MR. JAFFE: But I don\'t think they make a distinction between crops and
animals.

DR. MELLON: Well, some of them don\'t. I mean, I agree they apply to
use.

DR. LAYTON: And that\'s why I went with the production word instead of
planting word.

DR. SLUTSKY: Why can\'t you use the word use? Why is that? Because
you\'re using the feed.

DR. CRAMER: The reason being that it doesn\'t ban me from going to the
grocery store and buying a transgenic organism if it were for sale. So,
it\'s the actual production.

DR. SCHECHTMAN: If the squash were grown somewhere else that you could
\--

DR. MELLON: You could even harvest them someplace else and bring them to
your factory.

DR. SLUTSKY: I don\'t understand what that means, that you can\'t use
the word use.

DR. DYKES: Yeah, but use, I don\'t think using the word use changes that
concern at all. I think use works.

MS. TUCKER FOREMAN: And it\'s short.

DR. DYKES: And it\'s short. It\'s about as short as you can get and I
can understand it until Carole started talking anyway.

MS. DILLEY: Do we have the right context then? Alison, do you have a \--

DR. VAN EENENNAAM: You know, you can still use Roundup Ready^®^ hay to
feed your dairy cattle. You just couldn\'t grow it in the county.

DR. DYKES: That\'s right.

DR. VAN EENENNAAM: And, so, it doesn\'t prohibit the use. It\'s the
growth.

MS. DILLEY: So, it is production.

DR. LAYTON: It is production.

DR. DYKES: I think we\'re talking in this example we\'re talking about
one specific issue in California. There\'s 80 some different variations
of this across the 50 states.

DR. LAYTON: Okay. Certain uses.

MS. DILLEY: We we\'re just offering certain uses and we\'re spending too
much time on this one when we\'ve got a lot more to do.

DR. LAYTON: Certain uses.

MS. DILLEY: Can we do certain uses?

DR. LAYTON: Okay.

DR. DYKES: There you go.

DR. SHURDUT: So, this not include all the labeling and this is of the
state laws.

MS. DILLEY: This is not that one, I don\'t think.

DR. LAYTON: There\'s another one that\'s coming up on labeling.

DR. SHURDUT: Marketing uses and commerce issues?

MS. TUCKER FOREMAN: There are some state activities that would require
labeling, isn\'t that right? They don\'t prohibit the growing. They just
require the labeling. But that would be covered by regulation.

DR. LAYTON: Yeah.

DR. DYKES: To me, I just thought we tried to meet and convey the general
nature of there\'s possibilities for a lot of differences here, certain
uses.

MS. DILLEY: So, do we have the topic sentence pinned down?

DR. LAYTON: Okay.

MS. DILLEY: Do you want me to read it?

DR. VAN EENENNAAM: Yeah, read it because it doesn\'t quite \-- after or.

MS. DILLEY: Okay. So what we have right now is public ballot or
legislative initiatives at the state and/or local level in the United
States to establish moratoria on certain uses of transgenic organisms or
to regulate them will lead to regulatory differences across the country
and will impact the use of these products.

DR. DYKES: Is products right or is organisms there?

MS. TUCKER FOREMAN: I can go with that, but you know, you might \-- and
we\'ll talk about it when we edit, but you might make it less cumbersome
if you said regulatory differences that arise from. Let\'s don\'t worry
about it now if everybody\'s in agreement.

MS. DILLEY: We got the general gist. We just need to make it
grammatically correct.

MS. SULTON: We know we have to come back and make it correct.

MS. DILLEY: Okay. Is there anything else within the explanatory text;
there are others? Anything else on this one?

MR. JAFFE: Are you talking about the body now?

DR. DYKES: Yeah.

MR. JAFFE: Okay. I had a number of edits but I think there is a
difference among committee members. I proposed some language to address
that. Do you want me to take them by sequence, by sentence, or, how
would you like me to deal with that?

MS. DILLEY: Can you just describe briefly the overall gist of it and
then we can go to specific language?

MR. JAFFE: I guess I was \-- the last sentence was the one that I think,
therefore, needed to go to a some members say this, some members say
that because the potential impact of where regulations could
significantly increase systemic costs, affect commerce, and slowly
develop of new products, I think that\'s probably some members believe
that. I was proposing adding that other members believe that state,
local involvement in the regulation of transgenic organisms may lead to
greater safety, increase information to the public, and more transparent
and participatory regulatory process, and a regulatory system that is
more responsive to the public\'s concerns.

I mean, I think there are two points. I mean, in some cases state and
local regulations are beneficial. They add safety, they give
information. If they make different Sunshine laws, there\'s a host of
things. So, that\'s my proposal. It\'s in my draft there. I think it\'s
a simple addition for the first one, the sentence before saying some
members believe that and then adding that additional sentence.

I\'d ask Carol whether she\'s in agreement with those points. Those
points could be edited. There are other people who agree with them, I
think, but they\'re generic enough. So, that\'s my big point.

MS. DILLEY: The range of perspectives is on the implications of those
initiatives basically?

MR. JAFFE: Right. So, do you want me to take the other ones or do you
want to \--

MS. DILLEY: No, just put that on the table for now. Michael?

DR. DYKES: I have a question, Greg. If we dropped the supply sentence,
would that \-- in an effort to try to keep from some members and other
members if we dropped the last sentence would that take care of it?

MR. JAFFE: I mean, then why have the issue?

DR. DYKES: Don\'t. Just asking.

MR. JAFFE: I mean, the whole point of some people raise this issue is
they\'re concerned that \--

DR. DYKES: I just didn\'t know if you were hell-bent to put that issue
in there. If you are, then let\'s go with some members and some other
members. I was just looking for some way to compromise so we don\'t have
every one of these be some members and other members.

MR. JAFFE: Actually, we have very few of them so far that have some
members.

DR. DYKES: I don\'t have a recall how many have some members and other
members, but that\'s all.

MS. DILLEY: Carol?

MS. TUCKER FOREMAN: Yeah. I actually think we\'ve kept that relatively
under control. It\'s the view of my organization that that states are
\-- and I remember this from high school \-- the laboratories of
democracy and that when states want to enact standards that are higher
than the federal standard we support them. If they want to have lower
ones, we don\'t.

You can\'t use state law to drag the standard down but you can raise it.
That\'s kind of a given for Consumer Federation of America so I just \--

MS. DILLEY: Okay. So, the point, I think we\'re back and forth, has been
if we keep this topic in we need to explain the take away message of
people\'s differing analysis and different initiatives and then we\'ve
got to explain and then we have to propose language as to how to flush
that out.

Ron?

MR. OLSON: I just had a question. The efforts undeniably represent the
views of a segment of the population. Do we need to say that or is that
just redundant? If they passed the law they obviously \-- or somebody
believes it?

MS. TUCKER FOREMAN: Some of them don\'t pass.

MR. OLSON: So, you\'re talking about the efforts, okay. I see what
you\'re saying.

MS. TUCKER FOREMAN: If they\'re successful.

MR. OLSON: I see what you\'re saying. Okay. I can live with it either
way.

MS. DILLEY: Okay. So, we need to add Greg\'s language; at least put it
up there in terms of the some members think and other members think and
take a look at it.

DR. HUNT: I think if we\'re going to have some think and still others we
could say some members think the potential patchwork of regulations will
significantly increase.

MS. DILLEY: Right.

DR. DYKES: If we\'re going to go some members think I think we go back
to what we had in.

MS. DILLEY: Right, absolutely. Makes sense. Duane?

MR. GRANT: I would agree with Josephine and Mike and would suggest that
if we are going to some members we need to strike that sentence that
says these efforts that represent, that can be captured in the some
members position and then I would like to amend or add a phrase in the
position of some members that believe would increase costs and also
deprive consumers of choice.

MS. TUCKER FOREMAN: You\'re going to have to explain the factual basis
for that.

MR. GRANT: That\'s very \--

MS. TUCKER FOREMAN: There's no products that have direct consumer
benefit.

MS. DILLEY: Some members think though, you don\'t.

MR. GRANT: Actually it\'s very factual and if you remember actually
Austin Sullivan, our good friend, was the author of that phrase, in my
mind, and his often repeated contention was that if labeling was
required that General Mills would not use GM products and, therefore,
deprive the consumers of the ability to benefit from those products.

MS. TUCKER FOREMAN: You actually, I think, are not quoting him directly.
It was customers, farmers, but since there are no direct retail benefits
in foods produced by biotech at this time you can\'t say that.

MS. DILLEY: I don\'t know if we want to \-- I mean, I guess the only
question is, is there a way to \-- it doesn\'t sound like there\'s a way
to find unified language. I think this is where we get into the more
challenging in terms of fleshing it out, but so, if that\'s where we\'re
going to go, then I think that some members get their opportunity to put
what they think and other members

think \--

MS. TUCKER FOREMAN: Then that\'s factually incorrect.

MS. DILLEY: No, no, Carol, wait, I don\'t know if some members think
that customers or consumers are deprived and they get to say that
because they think that.

MS. TUCKER FOREMAN: Okay.

MS. DILLEY: So, and then other members think and then we leave it at
that.

MS. TUCKER FOREMAN: May I make a reference back to the sentence about
these efforts undeniably represent, how about if you precede this with
if these efforts pass they represent segments of the population. You got
to get a majority on an elected body or through a public ballot
initiative to have them pass so they obviously \-- it is factual that if
they pass they represent.

MR. GRANT: And, so, add another phrase line and say if they fail then
they don\'t represent. I mean, it doesn\'t add anything to the paragraph
in my opinion.

MS. DILLEY: Michael, did you want to add to that and then we\'ve got
Leon?

DR. DYKES: I would suggest that if we\'re going to go to \-- to me, if
we\'re going to go to some members/other members then we need to spend
\-- we need to spend some time on other changes in this thing so that
we\'ve got it where the some members and what Greg\'s articulated and
what other members. We need to come through and make some changes.

I don\'t know if that sentence adds anything if we\'re going to the some
members and some others.

MS. DILLEY: So let\'s take it out and then we go to a potential \--

MR. JAFFE: Use efforts undeniably represent.

MS. DILLEY: Right. These efforts undeniably represent. We\'re striking
that and then you\'ve got the first two sentences and then you move to a
potential patchwork of regulations will significantly increase systemic
costs.

MR. JAFFE: Some members believe.

MS. DILLEY: Sorry. Some members believe. You\'ve got it up here, right?

MS. SULTON: Yes.

MS. DILLEY: Some members believe that a potential patchwork of
regulations will significantly increase systemic costs, affect commerce,
deny choice, and slow the development of new products. Others think that
state and local involvement with the regulation of transgenic organisms
may lead to greater safety, increased information to the public, and
more transparent and participatory regulatory process, and a regulatory
system that is more responsive to the public\'s concern.

MR. JAFFE: Just say other AC members or other members.

MS. DILLEY: Oh, other AC \-- right, other members.

DR. DYKES: Did we leave systemic costs in there?

MS. DILLEY: I\'m sorry?

DR. DYKES: Did we leave systemic costs?

MS. DILLEY: Yes.

DR. DYKES: I don\'t know what \-- I\'ll ask, I don\'t know what systemic
cost is.

DR. LAYTON: System cost.

MS. DILLEY: Do you want costs? Is it marketing production? What is it,
costs? Just increased costs?

DR. LAYTON: Significantly increased costs.

MS. DILLEY: Okay. Increased costs.

MR. GRANT: I like systemic. The definition of the word just means
throughout the entire organism so systemic means it\'ll increase costs
through the whole system.

DR. DYKES: Just say costs throughout the whole system.

MS. DILLEY: Through the food and feed chain. Is that what you\'re \--

DR. DYKES: Systemic, I guess, is coming back to me to mean some kind of
organ. It\'s really knotty or something.

MS. DILLEY: So, increased costs. Are we sticking with that? Increased
costs throughout the system, is that what \-- okay.

Leon, Alison, and then Mardi.

MR. CORZINE: One more change. On the some. Rather than affect commerce,
would impede commerce.

MS. DILLEY: Impede. Okay. Mardi and then Greg.

DR. MELLON: I\'m trying to think of what we want to say to the Secretary
and what seems to me, what is significant to me in the proliferation of
these initiatives is that the adequacy of the federal regulatory system
is a huge issue. That\'s what they talk about all the time. We need to
do it ourselves because the Federal Government is not doing it because
the safety regulations are not strong enough because the oversight of
environmental risk is not strong enough.

It seems to me, you know, without resolving it \--

MS. DILLEY: So we need specific language?

DR. MELLON: \-- that we might want to note that the adequacy of the
federal system is a big \-- these things are not coming out of nowhere.
And that it is a big issue in these local \--

MS. TUCKER FOREMAN: Other AC21 members believe the state and local
involvement is a response to inadequate federal regulation.

DR. MELLON: Is a response to.

MS. TUCKER FOREMAN: Is a response.

MS. DILLEY: You want to define it as that? I mean, I guess to me that
means you\'re adding on what other members think and I\'m not sure \--

MS. TUCKER FOREMAN: No, no. I\'m adding it to our views.

MS. DILLEY: I know, I know, I know. I\'m just trying \-- that\'s a long
sentence so I\'m trying to figure out where to add it in there.

MS. TUCKER FOREMAN: Other AC21 members believe that state and local
involvement with the regulation of transgenic organisms is a reaction to
inadequate federal regulation and may lead to so on and so forth.

MS. DILLEY: Is it and or is it that may lead? It doesn\'t sound \-- it
is right. All right. Never mind. Never mind.

MS. ZANNONI: So, should the other side, the other members talk about the
federal regulations are adequate? I mean, if you look at those two
things it looks like \--

MS. TUCKER FOREMAN: We\'re going to say that in another issue.

DR. HUNT: I was going to say, we have a topic covering that, it\'s
number 17.

MS. DILLEY: The adequacy of a federal \--

DR. HUNT: It\'s worded too much here. We can address that in another
topic.

DR. LAYTON: Would you be comfortable with that, Carol?

MS. TUCKER FOREMAN: Well, you know, I think Mardi\'s raised a good point
that why it is that these things spring up. You know, they require more
than just a half dozen people out there in a county getting something
passed in the county and many of them don\'t pass. But there is a
substantial number of people in each of these places who feel that
they\'re not \-- their interests are not being served.

MS. DILLEY: So, what I\'m hearing is if that\'s added you\'ve got to
have some kind of parallel statement. Is that what people are saying?
So, Carol\'s saying, yes, it\'s important to have it in there, so, Lisa,
your point is we need to have a parallel clause?

MS. TUCKER FOREMAN: You know, you might want to have a reality check
during lunch break and see if everyone thinks that.

MS. DILLEY: I think the issue is raised in other places and if it\'s
important to raise it in this one then we just need to balance it out. I
think that\'s where we are. I don\'t think we need to belabor it. We
either need to add a clause in another sentence and then move on or
delete it from both.

MS. TUCKER FOREMAN: I think it\'s okay to say \-- you know, I don\'t
want to tell the other side what to say, but they think that some
members believe the current regulatory \-- federal regulatory system\'s
just fine and that patchwork will significantly improve.

MS. DILLEY: Do you have language that \--

MR. CORZINE: Some members believe.

MS. DILLEY: So, in the previous clause you need to add something about
the adequacy of the regulatory system.

MR. CORZINE: Federal regulatory system being adequate and a potential
for patchwork regulations.

MS. DILLEY: Is that okay with people now; it\'s more parallel?

DR. CRAMER: No, she didn\'t put it in the right place.

MS. ZANNONI: Yes, she did.

DR. LAYTON: If you put the second believe at think.

DR. SHURDUT: Just put some members believe.

(Discussion off the record)

MS. DILLEY: Okay. Some members believe the federal regulatory system is
adequate and think that the potential patchwork of regulations will
significantly increase costs throughout the system and impede commerce
and slow the development of new products. And then other members think
that state and local involvement with the regulation of transgenic
organisms is a reaction to inadequate federal regulation and may lead to
greater safety, increased information to the public, and a more
transparent participatory regulatory process, and a regulatory system
that\'s more responsive to the public\'s concern.

Okay. Are we there?

MS. TUCKER FOREMAN: It seems to be longwinded in parts.

MS. DILLEY: Can we move on?

MR. JAFFE: No. I said I had two other comments I had that you asked me
to give that first one and then we\'d come back to them.

MS. DILLEY: Okay. I didn\'t know you had more comments.

MR. JAFFE: Two other suggested editing language changes for accuracy
purposes. First, I would delete the including food products in the first
sentence.

MS. DILLEY: So, regulation of genetically engineered agricultural
products is \--

MR. JAFFE: Genetically engineered agricultural products. Right, because
I \-- that is primarily filled by the federal government.

MS. DILLEY: Okay.

MR. JAFFE: When you talk about food products, first of all, they don\'t
specifically regulate genetically engineered food products.

MS. DILLEY: I don\'t hear any disagreement with you.

MR. JAFFE: Okay. Second one is in the second sentence. I mean, I would
have changed recent initiatives to recent public ballot initiatives, but
we can keep that in, have been launched in certain states and counties
seeking to, and I would substitute regulate the commercial use of
transgenic plants or animals. I think that\'s more accurate.

MS. DILLEY: Regulate \--

MR. JAFFE: The commercial use of transgenic plants or animals.

DR. MELLON: I don\'t think it\'s commercial use. Most of it\'s plants.

MR. JAFFE: Well, that\'s commercial use. I mean, that\'s a commercial
use. The plant seed and then you

take \--

DR. MELLON: It doesn\'t matter why you\'re planting, whether it\'s for
commerce or \--

DR. LAYTON: They\'re not regulating the universities from using them in
research. In other words, he\'s separating that out.

MR. JAFFE: Right.

DR. MELLON: I didn\'t \--

MR. JAFFE: And also there\'s additional control. It\'s different
control. I mean, it\'s \-- you know \--

MS. DILLEY: What\'s the suggested language? Seeking to?

MR. JAFFE: Seeking to regulate the commercial use of transgenic plants.

MS. DILLEY: And taking out additional control over raising?

MR. JAFFE: Raising.

MS. DILLEY: Okay.

MR. JAFFE: These are also ones that have been deregulated so there is no
more federal control over them so to say there is additional control,
there is no federal control.

MS. DILLEY: Okay. So, now that sentence reads, recent initiatives have
been launched in certain states and counties seeking to regulate the
commercial use of transgenic plants or animals and then some members and
we go on from there to some members.

MR. CORZINE: I think you want further regulate or something because
it\'s additional regulation.

MR. JAFFE: It isn\'t.

MS. TUCKER FOREMAN: It\'s just different.

MR. CORZINE: Well, it\'s further.

MR. JAFFE: Some of them aren\'t regulated at that point. They\'re
deregulated.

MR. CORZINE: As I read that, it says that it\'s not regulated unless
there\'s an issue.

UNIDENTIFIED FEMALE: It is further then.

MR. JAFFE: It\'s not further. They\'re not regulated.

DR. DYKES: What\'s not regulated?

MR. JAFFE: Well, they say it\'s unregulated. They\'re no longer
regulated. I mean, they\'re deregulated. They said we have no regulatory
authority over them. They\'re not regulated. They\'re not a regulated
article. And now the county of California is saying you can\'t grow
them.

(Discussion off the record)

MS. DILLEY: Additionally regulate? Is that what you\'re saying?

DR. LAYTON: Individually regulate? I don\'t know.

MS. ZANNONI: It looks like it\'s not regulated at all.

MR. JAFFE: They\'re seeking directly, not additional controls.

MS. DILLEY: To make decisions about?

DR. DYKES: I don\'t agree with there aren\'t additional controls.
That\'s the whole purpose of trying to do them is to be additional
controls.

MR. JAFFE: There are controls. I\'m arguing that they\'re not additional
because there are some states where there aren\'t any controls. How can
you have no controls and how can you say it\'s additional?

DR. LAYTON: Okay. Well, zero is here, one is additional.

MR. JAFFE: No.

MS. TUCKER FOREMAN: Let me make a suggestion. One group can argue that
we should not have these moratorium can certainly say these additional
regulations down there.

DR. LAYTON: Yes.

MS. DILLEY: That additional state and local involvement.

MS. TUCKER FOREMAN: You know, add anything you want to say right there.

MS. DILLEY: Okay. So, where we\'re putting additional is?

MR. GRANT: Potential for additional regulations.

MS. DILLEY: So \--

MR. CORZINE: Yeah, but still, recent initiatives launched in some states
that are seeking to regulate.

MS. DILLEY: So \--

MR. CORZINE: It\'s implying there\'s no regulation. I don\'t agree
there\'s no regulation.

MS. DILLEY: \-- that a potential additional patchwork. Is that where
you\'re adding it?

DR. VAN EENENNAAM: Yeah, additional, right where she\'s got her pointer.

MS. DILLEY: Patchwork of additional regulations. Okay. Okay. Can we put
this one to bed? No?

MR. CORZINE: Just because in that sentence it infers in the one above
that there\'s no regulation and I don\'t agree.

MR. JAFFE: Up above it says regulation is primarily the role of the
federal government. It says regulation of genetically engineered
products is a role that\'s primarily filled by the federal government
and you can say and they have a host of regulations to do that.

DR. VAN EENENNAAM: How about actively regulate?

DR. SCHECHTMAN: Could you fix that by saying something that said new
controls \--

MS. TUCKER FOREMAN: Put that up to the topic sentence.

DR. SCHECHTMAN: Seeking to assert new controls.

MS. DILLEY: That\'s a good one.

DR. LAYTON: New controls.

DR. SCHECHTMAN: Seeking to assert new controls. Does that \--

DR. VAN EENENNAAM: How about to locally regulate?

MS. TUCKER FOREMAN: To regulate locally.

MS. DILLEY: To regulate locally.

MR. CORZINE: Yeah, or something like that.

MS. DILLEY: Okay. Have been launched in certain states to regulate
locally the commercial use of \--

DR. LAYTON: Josephine.

DR. HUNT: Yeah. Something doesn\'t quite not search for me. Say recent
initiatives have been launched in certain states seeking to regulate
locally the commercial use of transgenic plants and animals. And then
you say some members believe that the federal regulatory system is
adequate suggesting for plants and animals just as you did in the
previous sentence whereas transgenic animals, we\'re not there yet.

So, that doesn\'t quite tally up, I don\'t think. This goes back to my
original point of where we\'re talking about the existing regulation
that\'s covered in topic 17. So, it does to me muddy the waters here
somewhat.

MS. DILLEY: To talk about the federal regulatory system.

MS. ZANNONI: Can we just limit this to plants?

DR. CRAMER: How about we focus on crop containment which this really is
and then put a last sentence saying transgenic plants are \-- I mean,
transgenic animals or something is another issue.

MR. JAFFE: And the initiatives are talking about organisms. In fact, you
know, one of my critiques of the ordinances, the issues are so broad
they would include medical drugs sometimes, everything, and, I mean,
they do. They\'re very broadly written.

MS. DILLEY: Yeah, I mean, but Josephine\'s right. It makes it a pretty
blanket statement of the federal regulatory system being adequate and
we\'re talking about other things where they\'re not adequate in other
topics so we need to \-- yeah, Leon?

MR. CORZINE: Here\'s some help. We were having some of the same issue
because we\'re wanting to see the system move forward, so adequate is a
tough word. Maybe if we said instead some members believe that local
initiatives are not necessary. Local regulation is not necessary and
think da, da, da, da, da and scratch the federal regulatory system out
of it.

MS. DILLEY: Okay. Is that better? Do you want to add the clause on
should be done at the federal level? Josephine or \--

MR. GRANT: Up at the top say traditionally filled by the federal
government.

MS. DILLEY: Okay.

DR. SCHECHTMAN: In light of federal regulations.

MS. DILLEY: Okay. In light of federal regulations. Does that help? Okay.
So, I think we\'re there on this one.

DR. LAYTON: Okay.

DR. SCHECHTMAN: Going once, going twice.

MS. DILLEY: We\'ve got 20 minutes so let\'s do an easy one.

DR. MELLON: What about 13?

MS. DILLEY: 13? This is the emergence of markets, non-transgenic
markets.

DR. LAYTON: We didn\'t do 19 yet.

MS. DILLEY: No. So, 13 on the draft circulated yesterday is on page 14.

DR. LAYTON: I have left that we need to do 2, 3, 4, 5, 8, 9, 10, 11, 12,
13, 15, 17, 19, 20, and 21.

MS. TUCKER FOREMAN: 23 and 26.

DR. LAYTON: We\'ve got 23. We just did 26 so we\'ve done 25, 26, 27, 28.

MR. JAFFE: And 10.

DR. LAYTON: I have 10 up here. We\'ve only done 10.5. I have 10. 8, 9,
10. I\'m scratching out as we do.

(Discussion off the record)

MS. DILLEY: It\'s not like we\'re taking on the easy ones here, guys.
Give yourselves credit. You\'ve waded through a lot of hard ones.

DR. LAYTON: And process-wise we\'re getting done what we need to get
done.

(Discussion off the record)

DR. LAYTON: Okay. Next. 13. I think we better go straight to the heart
of that one.

MR. GRANT: I like the colorful version. I don\'t see anything
controversial about it from my point of view. I think if we could just
adopt the edits that are in the colorful version we could go or we may
be able to go.

MS. TUCKER FOREMAN: You should have one that says some members think
regarding da, da, this and another report.

MR. GRANT: It does say that at the bottom.

MS. TUCKER FOREMAN: It looks fine to me.

DR. DYKES: I like it.

MS. DILLEY: Are you saying \-- which one, the colorful version?

DR. LAYTON: Okay. Going once.

MS. DILLEY: Any problems with any \--

MR. GIROUX: Can we just change with to involving in the topic sentence?

DR. LAYTON: Colorful version?

MR. GIROUX: Because it\'s new level of commercial risk. There was with
involving liability insurance instead of with.

MS. DILLEY: Involving.

MS. TUCKER FOREMAN: What line.

DR. LAYTON: 439 on the colorful version. Level of commercial risk,
delete with and substitute involving liability insurance implications
for some participants in the food and feed chain.

MR. GIROUX: Maybe just involving additional. Just so we understand,
they\'re always coming to us, but these are new.

MS. DILLEY: Involving additional liability insurance implications.

MR. GIROUX: Right.

MS. DILLEY: So, with that modification, can we accept the colorful
version?

MS. TUCKER FOREMAN: Creating an additional?

MR. GIROUX: Creating or \--

DR. LAYTON: Creating?

MR. GIROUX: Creating additional.

MS. TUCKER FOREMAN: It says really what it says.

DR. LAYTON: Okay. Going once.

MR. OLSON: It\'s just a fact check. Is the word unintended required
because I don\'t think this is specific to unintended presence. It\'s
the damage associated with the presence.

MS. DILLEY: The unintended \--

DR. LAYTON: It\'s 142 on the colorful version regarding unintended
presence of transgenic material.

DR. DYKES: This is regarding meat products?

MR. OLSON: It\'s presence, unintended or not.

DR. LAYTON: Okay. So, 442 on the colorful version we are substituting
the word the for unintended. And other than that, under 442 we changed
the word unintended to the, line 442.

MS. DILLEY: Okay. All set?

MR. OLSON: Hold on.

DR. LAYTON: Certain insurance companies have recently added exclusions
to their policies for claims regarding the presence of transgenic
material. This creates uncertainty as to which agency in the food and
feed chain will bear the liability for a transgenic-related claim.

MR. CORZINE: I wanted to ask Ron because if we\'re talking present
tense, I\'m not sure that that recently added is in there. There\'s one
that I know of that is actually recanted or brought some of that back so
I\'m not sure that statement is really factual.

DR. LAYTON: Okay.

DR. DYKES: Take out recently.

MS. DILLEY: Take out recently.

MS. TUCKER FOREMAN: Drop added so it says \--

MR. GRANT: Some have. Some have.

DR. LAYTON: Some have. Insurance companies have exclusions to their
policies for claims regarding the presence of transgenic material.

DR. DYKES: Would be excluded in their policies.

MS. TUCKER FOREMAN: Yeah.

DR. LAYTON: Certain insurance companies have exclusions in their
policies for claims regarding the presence of transgenic material. Ron?

MR. OLSON: Those claims arising from. It\'s not a claim for the
presence, it\'s a claim arising.

DR. LAYTON: Claims arising from rather than regarding.

MR. OLSON: Yeah, and, I don\'t know, Leon, I haven\'t followed it, just
some of that back.

MR. CORZINE: You know, I don\'t know that we put that in there, but
maybe there should be recognition that there has been a pullback from
that and one company that I know of in particular that had an exclusion
and removed it.

DR. LAYTON: Okay. But that\'s okay. Others still have one.

MR. CORZINE: Sure.

DR. LAYTON: Okay. So, here I have, certain insurance companies have
exclusions in their policies for claims arising from the presence of
transgenic materials.

MS. DILLEY: Okay.

DR. LAYTON: Is that what we want?

MS. DILLEY: Is that correct?

DR. LAYTON: Okay.

DR. SCHECHTMAN: Should the next sentence be in the past tense, this has
created uncertainty?

DR. LAYTON: No, it continues to create uncertainty.

MS. DILLEY: Okay.

DR. LAYTON: Some have already dropped back but we don\'t have to ask
that. We\'re just talking about certain ones still have it.

MR. CORZINE: That\'s what\'s running through my mind because they
haven\'t.

DR. DYKES: Maybe one of the ways to get your concern, Leon, you may say
while some companies have dropped their exclusions, certain insurance
companies have exclusions or while some insurance companies still have
exclusions.

DR. LAYTON: So, it\'s just certain companies that have it.

MR. CORZINE: Leave it the way it is. It\'s fine the way it is.

DR. LAYTON: Okay.

MS. DILLEY: It\'s acceptable to people then the way it\'s been modified?
It\'s finalized? Okay. 13, finished.

DR. LAYTON: Okay. It\'s done.

MS. DILLEY: Next one, how about 12. Okay. Do you want a minute to read
it?

DR. DYKES: I would just suggest maybe in the interest of time to go with
the colorful version. Does that meet people\'s needs?

MR. OLSON: The colorful version, right?

DR. DYKES: Yeah.

MR. OLSON: It meets mine.

DR. VAN EENENNAAM: There is a note saying \-- we\'re on 12, right.
What\'s the definition of off-type?

MR. OLSON: It\'s different than the type you\'re selling.

MR. GIROUX: It\'s a term of art used in the grain industry.

DR. VAN EENENNAAM: I know.

DR. SLUTSKY: It\'s a term of art.

DR. VAN EENENNAAM: It may not be commonly understood.

MR. GIROUX: Will the Secretary understand this?

DR. SLUTSKY: Yeah, he\'ll understand it. You know, this goes on a
website.

(Discussion off the record)

MS. DILLEY: Are you defining off-type?

MR. GIROUX: No, I think it\'s a term of art and \--

MS. DILLEY: Okay. I just didn\'t understand it. I don\'t know what
off-type means.

MR. GIROUX: You get a seed \--

MS. DILLEY: Types that are off?

MR. GIROUX: \-- from your orange shipment.

DR. DYKES: I\'m fine with the colorful version.

DR. SCHECHTMAN: Do you want a footnote or a definition of off-type if I
can find one, or, do you care?

MS. DILLEY: No, if people mostly know, I guess. It\'s an off-type on
this topic, I guess.

DR. SLUTSKY: You\'re an agriculture off-type.

DR. MELLON: Where\'s the opportunity in there though? I mean, we have
creating opportunities and challenges for the U.S. marketing system. We
talk about the efficiency of the system.

MS. DILLEY: Mardi, if you\'re talking to the group in general I don\'t
know what you\'re saying.

DR. MELLON: I\'m sorry. I was wondering if someone could comment on
where the opportunities are associated with commercial differentiation.

MR. GIROUX: What\'s that again?

DR. MELLON: On 12.

MR. GIROUX: The more complicated it is, the more opportunity to make and
create systems that nobody else has the ability to do so you have a
chance to cap the market share. You have a chance to make more money.
You have a chance to tie in the customers more directly. I mean, those
are the kind of opportunities we would say arise from the required
segregation or differentiation. I mean, the time of the control the more
opportunity there is, both negative and positive. That\'s how we define
it.

DR. MELLON: Okay.

MR. GIROUX: Both the opportunity and the challenge. The challenges
create opportunity.

MS. DILLEY: So clarify?

DR. MELLON: I\'m satisfied.

MS. DILLEY: Okay. So, Randy, are you ready to comment?

MR. GIROUX: Yes. Just one change I\'d like to make.

MS. DILLEY: On which document?

MR. GIROUX: The colorful version, line 490. The last sentence,
segregation of transgenic products that do have distinct function or
characteristics may be difficult because in some cases it\'s not.

MS. DILLEY: That\'s the second to the last sentence on the colorful
document, segregation of transgenic products that do not have distinct
functional characteristics may be difficult.

DR. DYKES: There\'s your opportunity. That\'s what I was thinking. That
may be different but you can charge like the world. But if they\'re not
difficult it\'s just a problem with somebody.

MR. GRANT: In the colorful version, the first sentence after the issue
statement, it has, you\'ve added in as long as there\'re commercially
viable tolerances for off- types. I\'d like to delete or propose that we
delete that and add in at the beginning of the sentence, this is a
current U.S. commodity handling system with the idea being that we keep
it shorter, simpler, not raise questions about what commercially viable
off-types might be.

MS. DILLEY: Okay. So, you\'ve got a period at the end of
characteristics?

MR. GRANT: Yes.

MR. OLSON: That\'s my addition and I\'m fine with it.

MS. DILLEY: All right. So, take it out. Okay. So, now it says the
current U.S. commodity handling system is extremely efficient at
managing commodity streams segregated by distinct functional
characteristics.

DR. LAYTON: Segregation of \-- that\'s what follows it?

MS. DILLEY: And then segregation of transgenic products that do not
have. Then it\'s the last two sentences and then that\'s it.

DR. VAN EENENNAAM: Stop at segregation.

DR. LAYTON: Just the strike through.

DR. VAN EENENNAAM: Yeah. What we struck out is gone. There you go.
Delete.

DR. LAYTON: Ron?

MR. OLSON: Just a question on current. I mean, current implies that the
future will not be or that the past was or wasn\'t. I mean, there isn\'t
anything other than the current system so are you implying then that
future system will not be?

MR. GIROUX: No. I think in my case, not the grain, but my agreement to
drop that is the current U.S. system for moving commodity grains does
involve commercially viable tolerances for off-types or adventitious
presence so if new models or biotech grain prescribe to those same
systems assigning those tolerances then it wouldn\'t be a problem. It\'s
a little convoluted perhaps.

DR. DYKES: Yeah, I\'m fine with current. I don\'t see any problems with
leaving the language we had in the colorful version. I just think it\'s
much more clear.

MR. GRANT: And I don\'t have a problem with either if the committee is
okay with it, but there were questions coming up about what are
commercially viable off-types.

DR. DYKES: We satisfied Abby\'s keep on the trade. We know what our
types are.

MS. DILLEY: Just because I\'m technically \--

DR. SLUTSKY: We\'ll explain it to her.

MR. OLSON: The reason I liked the detailed version is that it talks
about AP \--

DR. DYKES: Me too.

MR. OLSON: \-- because the market has \--

MS. DILLEY: Okay. So, we delete current and revert back to that language
then?

DR. LAYTON: But take out the word define in parentheses.

MS. DILLEY: Of course.

DR. LAYTON: Ron?

MR. OLSON: We had current in there, right?

MS. DILLEY: We took out current. I thought you didn\'t want current in
there so then it just reverts back to U.S. commodity blah, blah, blah.

MR. OLSON: This is a bigger explanation of what current implies so I can
live with current.

DR. LAYTON: Okay. Leave it out. Just leave it and under the red and
under the underline and we\'re done. We\'re out of this one.

Okay. 13 is done. 12 is done.

MS. DILLEY: Okay. So, should we go to lunch?

DR. CRAMER: Can somebody verify which version of 17 we\'re supposed to
be starting with in order to review this?

DR. LAYTON: The version from the side-by-side, the final side-by-side
that were outside and the version that is in for the editing for
January, that is also \-- both of those are correct. So, either way you
want to look at. There are no corrections on the side-by-side. It may be
easy to use the one that is version for editing at the January plenary.

MS. DILLEY: Okay. So, we still have kind of a process check. Okay. So,
we have an hour for lunch scheduled. So, if you could please review 17
and 23 in particular because we want to take those up after lunch. I
think, again, kind of with your best collaborative attitude that you had
let\'s try to work out and trying to finalize the language because we
still got a lot to do and the more we can be in problem-solving mode
when we come back the better. All right. Let\'s go to lunch.

(Whereupon, a luncheon recess was taken at 12:00 p.m.)

[A F T E R N O O N S E S S I O N]{.underline}

MS. DILLEY: Do you want to move to another topic and then when we get
the right language in the computer so you can look at it. So, you want
to move to 23. Are people prepared to talk about 23 because we don\'t
think we have the correct language, the most up-to-date correct language
that people have submitted that somehow has not been integrated into
what you\'ve been looking at. So, let\'s make sure that we\'ve got the
language that people want up there in terms of the most recent edits.

DR. LAYTON: It\'s there. It\'s in there.

MS. DILLEY: Which there?

DR. LAYTON: It\'s in the document version for editing at the January
plenary on 573. In considering this system, some AC21 members have noted
that all foods from biotechnology-derived plants that are on the market
today have successfully completed the FDA pre-market consultation
process and that the same safety standards apply to all foods regardless
of their source.

So the consultation process mirrors the voluntary process widely used by
the food industry to notify FDA prior to marketing new
conventionally-produced substances that are Generally Recognized as
Safe. The submissions reviewed by FDA scientists in their consultation
process provide the basis for the developer\'s conclusion that the food
is as safe as conventionally produced counterpart foods and may lawfully
proceed to market.

Their view is that although the FDA consultation process is technically
voluntary, the biotechnology and food industry understand that marketing
of food from a biotechnology-derived plant without obtaining the
appropriate clearance from FDA is simply not a viable commercial option,
making the FDA process effectively mandatory.

And then it goes on to say other AC21 members.

MR. CORZINE: Carole, that might be the best three sentences.

DR. CRAMER: Yeah.

MS. DILLEY: Aside from the count, is it the right language that you want
to work from? Okay. So, people, do you have the language that you would
like to see describing some members?

DR. CRAMER: That\'s what we want to work from. It got lost somewhere.
But you wrote an additional sentence out, Michael?

DR. DYKES: We originally had \-- the original had one more sentence in
there that didn\'t get captured there.

MS. DILLEY: So, you want to edit and you have the language and it goes?

DR. DYKES: I think I do. In submissions for review, FDA scientists in
their consultation process provide the basis for the conclusions that
the food is as safe as conventionally produced counterpart foods and may
lawfully proceed to market.

DR. CRAMER: The beginning is not there.

MS. DILLEY: That\'s in there.

DR. DYKES: Then I\'m on the wrong section.

MS. DILLEY: Look on the version for editing at the January plenary.

DR. SCHECHTMAN: The numbered version.

DR. DYKES: Oh, okay. My fault.

MS. DILLEY: Okay. I just want to make sure that we got the correct
language. And then \-- but that what\'s in number 18 for other AC21
members is now look at Greg\'s language? Is that \-- because this isn\'t
your language, right?

MR. JAFFE: It is.

MS. DILLEY: Oh, it is your language. Excellent.

DR. LAYTON: The only thing we have of the issue is the bracket at the
bottom.

MR. JAFFE: The bracket, I propose deleting.

DR. LAYTON: Okay. On this document it is starting at Ron\'s 603.

MS. DILLEY: So, the proposal in terms of any modification to 17 as it
stands in this document is delete the bracketed language at the end?
Does anybody have heartburn of deleting that?

DR. JONES: No, I have a \--

MS. DILLEY: Okay. This is a different point. So, can we delete that?

MR. JAFFE: Yes.

MS. DILLEY: Okay. Kathleen.

DR. JONES: Well, I don\'t know how good it is to delete that, but I have
another point earlier in the text.

MS. DILLEY: Right. Can you speak up?

DR. JONES: Sure. I have another point earlier in the text.

MS. DILLEY: Can you cite the line?

DR. JONES: I guess it is I would like to add something to my sentence
that starts on 572, the sentence, however, FDA does not require
pre-market approval of these products.

MS. DILLEY: Can you wait until people \--

DR. JONES: Sure.

MS. DILLEY: Okay. So, 572. Okay. So, however, FDA does not require
pre-market approval of these products. Okay.

DR. JONES: I\'d like to modify that to, "While FDA does not require
pre-market approval of these products, FDA does require pre-market
review and approval of food additives prior to commercialization
regardless of the method of production."

DR. DYKES: Would you repeat that?

DR. JONES: Changing the "however" to "while" and then following where
the sentence ends I\'d like to add, "However, FDA does require
pre-market review and approval of food additives prior to
commercialization regardless of the method of production."

DR. VAN EENENNAAM: That was pre-market approval of additives?

DR. JONES: Food additives.

MS. SULTON: Does require pre-market approval?

MS. DILLEY: Regardless of method of production.

DR. JONES: And I want to add that in because to date we\'ve only had one
product come through as a food additive that was \-- but in the future
with crops that are under development if the substances that are
genetically engineered into the plants are actually food additives they
would be required to undergo pre-market approval.

MS. DILLEY: So, that\'s making it technically correct.

DR. LAYTON: Does everyone on the committee agree to that? Some members
do think that?

MS. TUCKER FOREMAN: Yeah, I have one concern about it and that is I\'m
wondering if it requires us to exploring what a food additive is as
opposed to Generally Recognized as Safe.

DR. JONES: I can provide that language.

DR. LAYTON: Footnote it.

MS. DILLEY: Do you want it footnoted?

MR. GRANT: Can I make a suggestion?

MS. TUCKER FOREMAN: Okay.

MR. GRANT: Because I share \-- it seems kind of out of context without
any context to understand what we\'re talking about. I might suggest on
line 571 for foods and feeds derived from transgenic crops that are
considered GRAS, put the initials in there, FDA has a voluntary
consultative process to review safety data. I think that\'s a correct
statement.

And even though we don\'t define what \--

MS. TUCKER FOREMAN: It\'s GRAS, but I think so too.

MR. GRANT: Is that correct?

MR. JAFFE: I mean, it\'s not really correct for a number of reasons, but
I mean, it sort of in a sense of reads as if if they\'re already
addressed and they don\'t have to go through a process. I mean, it\'s
sort of the process determines at the end that they\'re GRAS. So,
you\'re sort of putting the cart before the horse.

MR. GRANT: I sort of see what you\'re saying.

MR. JAFFE: But also, and actually what they say is the DNA, DNA is GRAS,
and, so, it\'s not really a transgenic crop. When adding the GRAS I
think it doesn\'t add anything because it\'s again what these legally
defined terms like food additive.

MR. GRANT: What I was just trying to pull out was a distinction between
food additives and events that are not considered food additives because
the reference to food additives adds something to the discussion because
there is a point at which an event has to go through the additive
process.

DR. LAYTON: I think that if you define food additive that would make it
less ambiguous.

MS. DILLEY: You just want it footnoted, or, not?

MR. JAFFE: Clearly, at most, a footnote. To put it in the text it would
just go \--

MS. TUCKER FOREMAN: It would seem to me that if FDA determines that a
product is a food additive it\'s required to go through a pre-market
approval process.

DR. JONES: If it\'s a food additive as defined by law it must undergo a
pre-market review and approval. Otherwise, the foods are automatically
adulterated.

MS. TUCKER FOREMAN: No, I understand that. I\'m suggesting that if you
change the language to say if FDA determines it\'s a food additive then
it has to go through the approval process.

DR. LAYTON: But they don\'t determine.

DR. JONES: As defined by law, if it is a food additive, it must undergo.

MS. TUCKER FOREMAN: I understand, but FDA determines if it\'s a food
additive.

DR. JONES: I don\'t think so. I think that\'s a legal definition.

MS. TUCKER FOREMAN: If it is a food additive, is that what you\'re \--
what was your last \--

MR. JAFFE: Hers says \-- I think it\'s correct. I mean \--

MS. DILLEY: FDA does require pre-market approval of food additives.

MR. JAFFE: \-- I think she says while FDA does require pre-market
approval of food additives regardless of the method of production. It\'s
not \--

MS. DILLEY: Right. So we just need a footnote to additives, food
additives.

DR. MELLON: What it doesn\'t make clear is that there\'s these whole
foods will be considered food to contain food additives and will be
regulated as such.

MR. JAFFE: It\'s not making a statement about biotech. It\'s just saying
\-- I think it\'s a fair statement. It\'s saying while we don\'t have
pre-market approval for biotech crops we do have pre-market approval for
food additives regardless of the method of production. And, so \--

MS. DILLEY: So, that may include transgenic \--

MR. JAFFE: And, so, I think it\'s \--

DR. MELLON: You don\'t say that. I mean, that sounds like if you don\'t
have regulation for biotech crops and you do have regulation for food
additives it doesn\'t mean anything unless it\'s clear that the biotech
crops can be food additives.

DR. LAYTON: No.

MR. JAFFE: I\'m not saying it one way or the other. It\'s clearly
stated. I think FDA wants to say we\'re saying they don\'t have
pre-market approval for biotech crops. They say that. They do have
pre-market approval for food additives regardless of how those are
produced. If you want to put biotech or not in parentheses. I think if
you start going into the intricacies of the policy and the potential
it\'s going to eat up the whole paragraph.

DR. JONES: We can change regardless of the method of production to
whether produced by conventional or bio-engineering.

DR. LAYTON: Transgenic.

DR. DYKES: That\'s the same as saying regardless of the method of
production. You\'re just saying the same thing. But I think regardless
of the method of production, like you said, is fine.

MS. DILLEY: Okay.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: So, we will have a footnote about what a food
additive is?

DR. LAYTON: The definition, I think. Can you get that? Legal definition.

MS. DILLEY: Okay.

MR. JAFFE: The legal definition is something that\'s effective. Anything
that\'s new to food that\'s not \-- it\'s not really \--

MS. TUCKER FOREMAN: I actually think that the footnote ought to say what
is a food additive and what is generally recognized as safe in order
that we have it. These are terms of art.

DR. LAYTON: Do you want us to footnote generally recognized as safe?

DR. SCHECHTMAN: See previous footnote.

DR. JONES: Okay. That may be able to be defined.

DR. LAYTON: And the food additive and then we\'ll footnote it generally
saying see previous footnote. Okay. You\'ll trust us to do that? Okay.

(Discussion off the record)

MS. DILLEY: Alison, do you still have a comment?

DR. VAN EENENNAAM: Yeah, I do. I just wonder, in the topic sentence,
ensuring, is it showing the correct \--

MS. DILLEY: Is it e-n?

DR. VAN EENENNAAM: I don\'t know.

MS. DILLEY: Ensure. Okay. On another one?

DR. VAN EENENNAAM: And a minor one. Then I guess just there are
viewpoints with regard to page \-- to line 600 and a couple after that
on page 18 there\'s a statement there that the majority of Americans
respond with surprise and state that they would not be more \-- they
would be more inclined to accept food \-- that\'s a stated fact and I
guess I don\'t know if that\'s members think that most Americans think
that, or, are we saying that is a fact? Because the way it\'s written it
looks like it\'s a fact.

MS. TUCKER FOREMAN: It\'s a fair amount of survey research data that
shows when you say initiatives on food that biotechnology \--

MR. JAFFE: Is it a question?

DR. LAYTON: Can we attribute it a queue (sic) then? I just want to know.
I was just \-- it was just a suggestion.

MR. JAFFE: I think not.

DR. DYKES: He was talking to Pat.

DR. LAYTON: I\'m done.

MR. OLSON: Is the surprise part of that they certainly state they would
be more inclined to accept foods that are such processed but does it say
they respond to the surprise?

MS. TUCKER FOREMAN: That\'s kind of a quote from the food initiative of
food and biotechnology but I think that we could probably \--

MR. OLSON: Just state they would be more inclined to accept the food?

MS. TUCKER FOREMAN: Well, I\'m looking for another word for surprise.
They\'re unaware that it\'s not required and I think we can find a way
to say they\'re unaware instead of surprise. They respond they\'re
unaware.

MS. DILLEY: That they are unaware.

MS. TUCKER FOREMAN: And that they would be more inclined.

MS. DILLEY: And they would be more inclined.

MS. TUCKER FOREMAN: To accept the foods.

MS. DILLEY: Okay. I don\'t know whose card went up first, so, Alison,
are you finished with your comments? Then I\'m just going to start with
Josephine and head this way. So, Josephine.

DR. HUNT: Okay. Take us up to line 585 of the January plenary where it
states the biotechnology in the food industry understand that marketing
of food from biotechnology derived plants to obtain the appropriate
clearance from FDA is simply not a viable commercial option making the
FDA process effectively mandatory, whereas the food industry really
looking to make it a process for pre-market notification.

DR. VAN EENENNAAM: I can\'t hear you.

DR. SCHECHTMAN: I can\'t hear you.

DR. HUNT: It suggests here on the last sentence of the third paragraph.

MS. DILLEY: Yes.

DR. HUNT: And the biotechnology in the food industry says the FDA
process is effectively mandatory. I think the message to get across for
the food industry respectively is it should be made mandatory.

MS. DILLEY: I don\'t think we have three. No, we\'ve got a third group.

DR. HUNT: At least we should have a third group.

DR. LAYTON: Okay. Why don\'t we take food industry out of that and then
say at the end of that the food industry group would like this to be
made \-- would like this to be mandatory.

MS. DILLEY: For other members.

DR. HUNT: Voluntary consultation process. Voluntary to mandatory.

MS. TUCKER FOREMAN: Yeah.

DR. HUNT: So, it\'s just an extra sentence really to make that point.

DR. SCHECHTMAN: That\'s not true of everyone in camp number one.

MS. ZANNONI: Just take out recognizes that. Other committee members
think that.

MS. TUCKER FOREMAN: It is food use. It\'s generally speaking to some
people think it\'s fine. Some people think a review ought to be
mandatory and some think the consultation ought to be mandatory.

MR. GIROUX: The food industry agrees with everything in that first group
except for whether it should be voluntary or mandatory as reflected in
their positions.

MR. JAFFE: My understanding is that the biotech industry is also
supportive of the mandatory pre-market notification rule, so, I mean,
Monsanto and others, but maybe I\'m speaking for them, but they did
support that also, so, maybe you either should change the whole \--

MS. DILLEY: Well, either you take the biotechnology \-- either you take
the food industry out of that last parenthetical and do a different, a
group three, or, you need to modify that somehow to not reference the
effectively mandatory, I guess.

DR. SHURDUT: Well, you know, in speaking for the biotech industry which
is one company, I was at Monsanto, I think you\'re right. I mean, we do
support effectively having a mandatory system in place here, but I think
the last sentence isn\'t really stating that. It\'s just stating that
everybody goes through it so it has been effective and mandatory stating
a fact which is a little bit different than do we support a mandatory
system or not.

But I do think some members of the biotech industry do support making it
a mandatory system.

DR. SCHECHTMAN: But some don\'t.

DR. DYKES: I think biotech press releases saying they support a
mandatory system.

DR. SLUTSKY: I think we need to make, and I don\'t want to speak for
you, Kathleen, but I think we need to make a distinction between a
mandatory notification system and a mandatory consultation \--

DR. SCHECHTMAN: Consultation.

DR. SLUTSKY: \-- because I think those are two different things and, so
\--

DR. SHURDUT: Could we say a mandatory review process?

DR. JONES: Making a current consultation \-- there\'s making a current
consultation process mandatory and then there\'s creating a mandatory
pre-market approval process. They\'re two different things.

DR. SHURDUT: It\'s the first one. It\'s mandatory consultation.

DR. LAYTON: Okay. How do we say that?

DR. SLUTSKY: Then can I ask a question if I may just so I understand
what the different groups really want? Is the group that wants a
mandatory system, the one in the second and final paragraph, are you
asking for a mandatory consultation or like a food additive type system?

MR. JAFFE: I think the problem here \--

DR. SLUTSKY: I\'m just wondering if we have, you know, what difference
we have.

MR. JAFFE: There\'s a lot of differences here. I think that the problem
is different people use the word mandatory in very different ways,
although, and I say this with respect to everybody and other people\'s
positions around the table, FDA proposed a pre-market notification
process. They never used the word mandatory once in that rule or in that
proposal because they cannot, by law, say that it\'s mandatory.

The rule said we expect you to do this. If you don\'t do this, if you
don\'t get the response back, you\'re supposed to wait until you hear
from us. They never used the word mandatory. It\'s called a pre-market
notification, okay.

MS. DILLEY: So, we\'re mixing \--

MR. JAFFE: Different people have supported that. I think that has
different meaning, so, I think \--

DR. SLUTSKY: But that\'s actually not the question I\'m asking. I
understand.

MR. JAFFE: So, I don\'t consider that mandatory, okay. I don\'t think
FDA considers that mandatory.

DR. SLUTSKY: No, I understand that. That\'s not the question I\'m
asking. What I\'m trying to get at is not \-- putting aside the
notification now, okay?

MR. JAFFE: Okay.

DR. SLUTSKY: For the last group, you know, the group I presume you\'re
in and Mardi, you, are you asking for a mandatory safety assessment?
What are you asking for, I guess?

MS. TUCKER FOREMAN: A mandatory pre-market safety. Not a food additive.

MR. JAFFE: Not a food additive. An approval process. A process \-- I
look at it as two characteristics. It says that you cannot market the
product without going to FDA, okay, and FDA has to tell you the product
is safe before you can market it. There are two parts.

MS. DILLEY: It\'s a pre-market safety review and approval process.

MR. JAFFE: You have pre-market before you market it. You have to go
there and FDA has to say that it\'s safe. There\'s two aspects to it.
It\'s not a food additive process.

DR. SLUTSKY: Okay. So, then what I\'m asking, do we have other \-- I\'m
just wondering, how many camps we actually have because what you just
said, Brad, was is that inconsistent with what a mandatory review? I
guess what I\'m saying is \--

MS. DILLEY: We\'re mixing notification and consultation.

DR. SLUTSKY: \-- there\'s not much we can do about this, but if it\'s
going to be helpful, you know, information.

MS. TUCKER FOREMAN: If USDA went to Congress and said \--

DR. SLUTSKY: I retract that statement. But for us to understand what the
different groups actually want I think we have to be pretty careful in
terms of what we\'re stating because when I\'m hearing you I\'m not
hearing all that many differences and I suspect there are.

MS. DILLEY: I think we\'re mixing notification/consultation,
mandatory/voluntary.

DR. SLUTSKY: No. I think we\'re mixing \-- I don\'t think it\'s a
notification versus consultation.

MS. DILLEY: Review?

DR. SLUTSKY: I think review and what that means.

MR. JAFFE: I think it\'s mandatory. The difference is the word
mandatory.

MS. TUCKER FOREMAN: Yeah. Voluntary and mandatory.

MR. JAFFE: I mean, unfortunately, this issue has a lot of history to it.

DR. SLUTSKY: I know. I know. I know.

MR. JAFFE: And a lot of things and the difference really is \--

DR. SLUTSKY: And I don\'t want to make it into a big \--

MR. JAFFE: \-- is the limits to what the statute has currently and the
statute is, as was told by FDA colleague, is that the only thing that
gets mandatory pre-market approval is a food additive. If it\'s not food
additive then it\'s generally recognized as safe.

DR. SLUTSKY: I understand that. I understand all that.

MR. JAFFE: So, the industry position is they\'d like to craft within
that some sort of review process by FDA. Others of us say that the only
way we\'d ever make it mandatory is to change the statute because the
only mandatory one is the food additive.

MS. DILLEY: I think that\'s the confusion. To me, the confusion is the
last sentence of the first group of people. I\'ve heard a distinction
between, and that\'s what we\'re trying to clarify, is you have their
view is that although the FDA consultation process is technically
voluntary, but Jo, you were bringing up the issue of making it
effectively mandatory, that that\'s where the confusion is in that
sentence.

And I\'m trying to figure out how we fix that sentence and then in
fixing that sentence is there two groups or one group. Mardi?

DR. MELLON: I think it is a complicated issue, but as I understand it,
what the industry would like would be for the consultation to be
mandatory. The USDA would \-- companies would have to come to USDA \--
sorry \-- to FDA before they went on the market, but it would still
remain \-- the safety decision would be one made by the company. It
would not be \-- at the end of the day there would still be a letter
that said the USDA \-- I mean the FDA, you know, I\'ve forgotten what
the language is \--

MS. TUCKER FOREMAN: The company believes.

DR. MELLON: \-- yeah, but the USDA has \-- has no questions about the
company\'s declaration of safety and that\'s what they would \-- and
that\'s the real rub is that we would like a process under which the FDA
assured the safety rather than the company.

MS. DILLEY: Okay. So \--

DR. JONES: Which is along the lines of a food additive approval process.

MR. JAFFE: The real rub is \--

DR. SLUTSKY: I understand all that.

DR. DYKES: The real rub is that doesn\'t exist today.

DR. MELLON: Right, and you would need the legislation.

DR. DYKES: And, so, in addition to do, and I agree wholeheartedly,
Mardi, but if you want to implement that, now, you\'ve got to come and
define a whole new process that\'s somewhere between the food additive
approval process and the current class system. So, that all that would
have to be identified and defined.

DR. MELLON: Right.

MS. DILLEY: Okay. So, how do we \-- do we need to fix that last
sentence, in their view is that although the FDA?

DR. DYKES: No. That sentence is fine the way

it \--

DR. LAYTON: But that\'s not what I \--

DR. DYKES: They want something that essentially codifies that last
sentence. The last sentence is accurate.

DR. LAYTON: Okay.

MS. DILLEY: So, you need to add another sentence.

DR. LAYTON: If they add a sentence, the food industry would like this.

DR. HUNT: We\'d have to work out who agreed to that because what I heard
Brad say was that it also \--

DR. SHURDUT: I think that the biotech industry is largely in agreement
with that last piece, the mandatory consultation. It surrounds the
approval.

DR. LAYTON: Okay.

MR. GRANT: Make the consultation mandatory.

MS. ZANNONI: So, what\'s effective in place today you just make that
voluntary to mandatory.

DR. LAYTON: Yes.

MS. ZANNONI: The process is the same. Okay.

MR. GRANT: It\'s a consultation process.

DR. LAYTON: Can we say they believe or they feel the process \-- the
consultation process should be mandatory?

DR. SHURDUT: And I\'d go beyond food industry.

DR. HUNT: To what?

DR. SHURDUT: Just food and biotech.

MR. GRANT: Just put they.

DR. LAYTON: Just put they or the industry?

MR. GRANT: This group.

DR. LAYTON: This group believes \-- could or should?

DR. DYKES: This group believes the process remain mandatory.

MS. DILLEY: We\'re basically saying it\'s effectively mandatory, but you
need to make it mandatory?

DR. DYKES: What we\'re saying today, everybody goes through it. But if
you want it, technically it is voluntary. But everybody \-- maybe you
put it on the market so it operates as though it\'s mandatory. And the
group would be fine making it mandatory because it didn\'t change
anything. Mandatory is what they do anyway.

DR. VAN EENENNAAM: How about should be made mandatory.

DR. LAYTON: Yeah, I was going to say should be.

DR. CRAMER: Just to historically remind you guys of why we wanted this
statement in at some point was that we didn\'t want this document to
emerge giving the implication that somehow everything that\'s come up to
now under \--

MS. DILLEY: It already states that. So, you still want it is technically
mandatory but we want to make it mandatory.

DR. CRAMER: Yeah. No, it\'s not technically.

MS. DILLEY: That\'s what it says in that first sentence.

DR. DYKES: Effectively mandatory.

MS. DILLEY: Okay. Have you changed the language? DR. LAYTON: You\'re
talking about that first sentence.

MS. DILLEY: Right now it reads as technically voluntary and then
effectively mandatory. That\'s what you want, but we want to make it
mandatory. Is that what \-- okay.

DR. CRAMER: I would be comfortable with. I like that term better.

DR. DYKES: Yeah.

MS. DILLEY: What term?

DR. CRAMER: This group would be comfortable with the consultation
process or something to that effect.

DR. DYKES: I think what Carole \--

DR. LAYTON: Believes what \--

DR. DYKES: I think what Carole\'s trying to get at here is, in my view,
everything that\'s written here is accurate. You could go further to say
that there\'s a group of people that would be fine, instead of that
operating as effectively mandatory being fine making it legally
mandatory if you want to, or, some words, and be comfortable with that,
but not to say that in such a way that it implies that that group two
believes that everything\'s been done heretofore has not been adequate
or not been sufficient. I\'m just trying to couch the concern of how you
put forth \--

MS. DILLEY: It\'s not saying that. What I\'m trying to find that right
last sentence. So, this group believes this should be made mandatory or
this group would support it?

MR. GRANT: Should be.

DR. CRAMER: I don\'t necessarily mean feel that it should be. I just
don\'t have \--

MR. JAFFE: It should say those members \-- these members.

MS. DILLEY: This group, those members. We\'re trying to \--

MR. JAFFE: Using the word members.

MS. DILLEY: Okay. These members.

DR. DYKES: These members would be comfortable.

DR. HUNT: No, you want it a bit stronger than comfortable.

DR. DYKES: Some of us don\'t. Not necessarily. You do.

MS. DILLEY: That\'s where you may have a division in the group, so, I\'m
trying to understand.

DR. LAYTON: The industry \--

MR. JAFFE: No, because it\'s not \-- we don\'t use industry because
we\'re referring to members.

MS. DILLEY: It\'s not industry. It\'s some members.

DR. VAN EENENNAAM: Would support?

MR. GRANT: Would support?

DR. HUNT: I think it\'s too weak.

DR. SCHECHTMAN: I think that varies between different members of your
\--

MS. DILLEY: Right, so, if we can\'t find a word that works then we have
to figure out to then capture what members think and others think.

DR. HUNT: Well, advocates.

MS. DILLEY: Well, advocates \--

MR. GRANT: What\'s the verbiage in the biotech industry in support of?
Is it they would support or \--

DR. DYKES: I think it\'s we would support making the current whatever
term mandatory.

MR. GRANT: So is the word should?

DR. LAYTON: Shall and will are two different words.

DR. DYKES: I think support means depending on what it is and so forth
and it doesn\'t cast aspersion, disparagement that what\'s happened
heretofore, therefore, it\'s not been adequate. I think that\'s the
concern.

MR. GRANT: The process becoming mandatory.

DR. HUNT: No, I mean, we\'re not saying it\'s what\'s gone before isn\'t
adequate. We\'re just saying that to make what\'s gone before voluntary
a mandatory process.

DR. DYKES: Yeah, I\'m with you on that. I\'m with you on that.

DR. VAN EENENNAAM: How about try support making?

MS. DILLEY: So, these members support making the consultation process
mandatory?

DR. HUNT: Get rid of the word \--

MS. DILLEY: Get rid of the what?

DR. HUNT: The word.

MS. DILLEY: These members support making the consultation process
mandatory.

MS. TUCKER FOREMAN: Try that on, Abby.

DR. MELLON: Why don\'t you just \-- could we try the some members of
this group are comfortable with the system. Others believe that it
should be made mandatory.

MS. DILLEY: I think it\'s these members support making the consultation
process mandatory.

DR. DYKES: We all support making it mandatory.

DR. MELLON: You all support making it mandatory.

DR. DYKES: Yeah.

MS. ZANNONI: Josephine, are you okay with that?

DR. HUNT: I think so.

MR. GRANT: Can you read that last sentence back?

MS. DILLEY: These members support making the consultation process
mandatory. The consultation process. This consultation process. This.

DR. DYKES: This instead of the.

MS. DILLEY: Okay.

DR. DYKES: This consultation. Yes, fine with that.

DR. LAYTON: Got it?

MS. DILLEY: Kathleen?

DR. LAYTON: Violent agreement, you all.

MS. DILLEY: Kathleen?

DR. JONES: I would just like clarification of their view on 584. What
are we referring to?

DR. LAYTON: The members\' view you mean, or, the food and biotech
industry?

MS. DILLEY: When you started saying these members.

DR. JONES: It looks like it\'s referring back to scientists.

MS. DILLEY: So, you want to say these members \-- the views of these
members? These members\' view?

Members \--

DR. CRAMER: I think we need to break that into two paragraphs.

DR. LAYTON: The members\' view.

MS. DILLEY: These members.

DR. LAYTON: That although the FDA process \-- consultation process is
technically voluntary, the biotechnology industry \-- the biotechnology
and food industry understand that marketing of food from biotechnology
\-- the members recognize that although the

FDA \--

MS. DILLEY: Did we just strike that clause, the biotechnology and food
industries\' view is that although FDA consultation processes is
technically voluntary, blah, blah, blah? Okay. So, just switch the
clause to the biotechnology and food industry\'s view is that the \--

MS. SULTON: Biotechnology and food industry\'s understanding? No?

MS. DILLEY: No. Just make it the biotechnology and food industry\'s view
is that although the FDA consultation process is technically voluntary
\-- then where does it go \-- marketing of food from biotechnology \--
yes. Okay. I\'m sure you understood that because I read it so well. Let
me read that.

Biotechnology and food industry\'s understanding \-- no, sorry,
industries understand that although the FDA consultation process is
technically voluntary, marketing of food from a biotechnology derived
plant without obtaining the appropriate clearance from FDA is simply not
a viable commercial option, making the FDA process effectively
mandatory. These members support making this consultation process
mandatory.

I don\'t care about strange.

DR. LAYTON: Let\'s not go through this. This is it.

MS. ZANNONI: Let\'s just say mandatory.

DR. LAYTON: Got it. Done.

MS. DILLEY: Okay.

DR. LAYTON: We\'ve got too many together.

DR. SCHECHTMAN: May I make one suggestion for clarification just to see?
At the beginning of the other members, therefore, should this be a new
or a separate mandatory process just so that it doesn\'t get one
mandatory process, another mandatory process below just for distinction.
Some additional adjective, just something that\'s clear that they\'re
not talking about the same process.

MR. JAFFE: That\'s it. Mandatory \-- that\'s how you describe it,
mandatory pre-market. The other one\'s not mandatory either. That\'s new
also. That one is new. I\'m not going to say this one is new when that
one \-- they\'re both new. That one is not a mandatory process either.

DR. LAYTON: If you\'re going to establish one it\'s new. I\'m sorry.

MS. DILLEY: No, no, no. It\'s a mandatory pre-market. It\'s a different
process. It would be making it mandatory, the other one mandatory would
be a new one too.

DR. SLUTSKY: The difference is one\'s a consultation process and one\'s
a pre-market approval process.

MR. JAFFE: Exactly.

MS. DILLEY: So, they would both be new if they were both mandatory.

DR. SLUTSKY: Yeah, and you don\'t need that because there\'s a
distinction.

MS. DILLEY: Okay. We\'re agreed.

DR. LAYTON: Okay.

MS. DILLEY: It\'s virtually every developed country. Right now virtually
every developed country. That was just a typo. And it\'s poised instead
of posed. Line 594, transgenic crops. That\'s what I\'m on.

DR. SCHECHTMAN: So, 17.

DR. LAYTON: Gone.

DR. SCHECHTMAN: And that point actually merits

a \--

MS. DILLEY: Good work everybody. Finally got the right language.

DR. LAYTON: Okay. Actually, it is in the numbered document. It\'s the
one that has constructions, what that change \-- you never saw the one
we were changing from.

DR. DYKES: We\'re doing 23?

DR. LAYTON: 23.

MS. DILLEY: You want a minute to read it over?

(Discussion off the record)

MS. DILLEY: Okay. So, what is on the numbered document for version for
editing on page \--

DR. LAYTON: 22.

MS. DILLEY: And it\'s the same as in the

separate \--

DR. LAYTON: Yes.

MS. DILLEY: All right.

DR. LAYTON: It is the same. Go to the next page. It runs from 720 to
761. I think Duane, then Greg, then Michael and I couldn\'t tell which
one went up first.

MS. DILLEY: Okay. We\'ll just go around the table. Duane.

MR. GRANT: I guess I was trying \-- in the issue statement, probably
somewhat predictably, and would agree that consumers are likely to seek
more information about their food. I guess I would disagree that
they\'ll seek in particular information about whether or not it is
genetically engineered and would suggest that we strike those last three
words and just put a period after food.

MS. DILLEY: So, about their food.

MS. TUCKER FOREMAN: May I propose at this point an alternative to that?

MS. DILLEY: Okay.

MS. TUCKER FOREMAN: Consumers are likely to seek more information.
Consumers are generally likely to seek more information about their
food, and, in particular, whether it\'s genetically engineered. Or does
it make it more difficult for you?

DR. LAYTON: Including?

MS. TUCKER FOREMAN: Including whether it\'s genetically.

MR. GRANT: You can introduce something like including nutrition and
actually I wouldn\'t even want the word genetically engineered there,
but just nutrition and source or something like that.

MS. DILLEY: A whole range?

MS. TUCKER FOREMAN: I seriously disagree with you.

MR. GRANT: We have a disagreement already below, but it\'s just whether
we want to say some people think in the issue statement that they\'ll
seek information about genetically engineered and some don\'t, or \--

DR. DYKES: I have a suggestion as well. I wonder if that really is the
topic sentence, or, if the topic sentence \-- I don\'t think it is. I
don\'t think the discussion\'s about whether they\'re going to want more
information or not if you read the text. I think the topic sentence is
AC21 members have different points of view regarding how strongly
consumers feel about information about whether the food is genetically
engineered.

MS. TUCKER FOREMAN: How about having \--

DR. DYKES: That\'s the topic.

MS. TUCKER FOREMAN: Except that when we go that way I think you may want
to say we have a difference in whether or not genetically engineered
food products should be labeled because that\'s the real topic of this
discussion. DR. SCHECHTMAN: Well, that\'s the second half of the
sentence. And the best way to provide that information is \--

MR. JAFFE: Well, we\'re talking about the topic sentence.

DR. SCHECHTMAN: Yes.

MS. TUCKER FOREMAN: If we\'re going back up to

the \--

DR. SCHECHTMAN: No, no. I had thought that Michael was quoting what is
now the second sentence of the first paragraph below and the second half
of that sentence, the very end of the paragraph says, and the best way
to provide that information to those who want it.

DR. DYKES: That, to me, is the topic or some variation.

MS. TUCKER FOREMAN: I would agree with it, but I, you know, the real
issue is whether or not it should be labeled. That\'s really what we
disagree with.

DR. DYKES: Well, maybe that is the topic, Carol. There\'s a \--

MS. TUCKER FOREMAN: If you keep the first half of it.

DR. DYKES: AC21 members have a different view as to whether the foods
should be labeled regarding biotech.

MS. DILLEY: So, it\'s AC21 members have different points of view
regarding whether transgenic products should be labeled?

DR. DYKES: Foods containing products derived from biotechnology should
be labeled, however you say it.

MS. TUCKER FOREMAN: No.

DR. DYKES: That\'s the issue.

DR. SLUTSKY: Maybe it should be labeled because they\'ve been produced
through biotechnology.

MR. GIROUX: Why couldn\'t you use the sentence and then say AC21 members
have different views regarding how strongly consumers feel about
information or whether their foods are genetically engineered, including
labeling.

MR. JAFFE: And whether it should be labeled.

MR. GIROUX: And whether it should be labeled. Because it\'s information
added.

MS. TUCKER FOREMAN: Say it again, Randy.

MR. GIROUX: It\'s in the paragraph. AC21 members have different points
of view regarding how strongly consumers feel about having information
about whether their food is genetically modified \-- genetically
engineered \--

DR. SLUTSKY: And whether it should be labeled.

MR. GIROUX: And whether or not it should be labeled.

MR. JAFFE: Whether or not.

MS. DILLEY: On whether it should be labeled.

DR. DYKES: Whether foods should be labeled.

MR. GIROUX: And whether the foods should be labeled.

MS. DILLEY: Okay.

DR. LAYTON: Wow. So, we\'re replacing that as a topic sentence. She\'s
getting it.

MS. DILLEY: Cindy\'s getting it.

DR. LAYTON: She is.

MS. SULTON: Hold on one second.

DR. LAYTON: She\'s going to.

MS. DILLEY: You got it.

DR. VAN EENENNAAM: Whether it should be labeled?

MS. DILLEY: And whether the food should be labeled. Did you put the food
in there?

DR. LAYTON: This is 23, not 22, Cindy.

MS. SULTON: Oh, did I mess up?

DR. LAYTON: Yeah. Up above. Take out what she just took out.

DR. SCHECHTMAN: Give her a second.

DR. LAYTON: Now, here.

DR. SCHECHTMAN: Yes.

DR. LAYTON: And leave that.

MS. SULTON: Okay. Got it.

DR. LAYTON: Okay. You can just cut and paste. Beginning with AC21
members.

MS. SULTON: Here?

DR. LAYTON: Yeah. Cut that, paste it above. Hold it. And then we have to
change the last phrase of that and whether the food is genetically
engineered and whether it should be labeled.

MS. DILLEY: And whether foods should be labeled?

DR. LAYTON: And whether it should be labeled as such. Whether the food,
not it.

DR. SCHECHTMAN: Whether the foods.

DR. LAYTON: Should be labeled as such.

DR. VAN EENENNAAM: And whether the foods.

DR. SCHECHTMAN: The foods.

MS. DILLEY: Should be labeled as such.

DR. VAN EENENNAAM: After and.

DR. LAYTON: And.

DR. VAN EENENNAAM: The foods.

MR. JAFFE: Whether.

DR. VAN EENENNAAM: Should be labeled as such.

MS. DILLEY: Okay. So, that\'s the topic sentence.

DR. SCHECHTMAN: Yes.

DR. DYKES: I think so too. I think that accurately describes what it is.

DR. SCHECHTMAN: Yes.

DR. LAYTON: Is everybody okay with that?

MS. DILLEY: Randy, did you have a comment? Your card is up.

MR. GIROUX: No, we\'re moving off the topic.

MS. DILLEY: I think if we\'ve got a topic sentence then we can move on
to the explanatory text.

DR. LAYTON: Unless Randy or Michael had other comments on topics?

DR. SCHECHTMAN: On topic sentences?

DR. LAYTON: Okay. Other comments.

MS. DILLEY: Randy.

DR. SCHECHTMAN: Greg, you\'re not up for a topic sentence?

MR. JAFFE: No.

MR. GIROUX: Just some clarification. I forgot the numbering. But the
third paragraph near the bottom it says these members believe labeling
of such products of modern biotechnology is the middle ground.

DR. LAYTON: That is on 743 on the version for editing at the January
plenary.

MR. GIROUX: Right. Believe that mandatory labeling, if I\'m correct, not
labeling, but mandatory labeling.

MS. TUCKER FOREMAN: That\'s correct.

MS. DILLEY: Okay. Mandatory labeling.

MR. GIROUX: And then one other. And that correction exists also on 759
version for editing, January plenary. It\'s the last sentence of the
section, to require mandatory labeling of products they believe, would
send the wrong message.

MR. GRANT: Should require mandatory labeling?

MR. GIROUX: Right.

DR. DYKES: The last sentence there.

MR. GIROUX: It\'s the last sentence.

DR. DYKES: On 759 of what Pat\'s handed out.

MS. TUCKER FOREMAN: Say that again.

MR. GIROUX: To require mandatory labeling of these products they believe
would send the wrong message.

MS. TUCKER FOREMAN: To require labeling. Require mandatory is redundant,
isn\'t it?

MS. DILLEY: No?

DR. DYKES: Or to mandate labeling.

MS. TUCKER FOREMAN: To mandate labeling. How\'s that?

MS. DILLEY: To mandate labeling. There you go.

MR. GIROUX: And then one other change. 754. For those consumers who want
to avoid these products organic products and non-GMO products.

DR. SCHECHTMAN: Non-genetically-engineered.

MR. GIROUX: Non-genetically-engineered products serve as an alternative.

DR. LAYTON: Organic and?

MS. DILLEY: Slow down.

MS. SULTON: Where are you Randy? I don\'t have numbers.

DR. DYKES: 755.

DR. LAYTON: She doesn\'t have the number.

DR. SCHECHTMAN: Right in the middle of the last paragraph.

MR. GIROUX: For those consumers who want to avoid these products.

DR. LAYTON: Here?

MR. JAFFE: Blueberries?

MR. GIROUX: No. Well, labeled products. I don\'t know, what do you call
them, the ones \--

DR. LAYTON: Non-transgenically derived.

MR. GIROUX: Non GMO. Okay. Maybe that\'s \--

MS. DILLEY: Okay. You guys are totally losing. People are trying to
transcribe and capture what you\'re saying.

DR. LAYTON: What did you want to say?

DR. VAN EENENNAAM: Organic products and \--

MR. GIROUX: I just want to include \--

DR. LAYTON: Organic products and \--

MS. TUCKER FOREMAN: Voluntarily labeled products.

MR. GIROUX: Well, Leon suggests some specialty products have been
developed. Some specialty markets.

DR. DYKES: And voluntarily labeled.

MR. GIROUX: And voluntarily labeled.

DR. LAYTON: Some organic products and?

DR. DYKES: Voluntarily labeled products.

MR. CORZINE: But it doesn\'t say what it is though.

DR. LAYTON: Are non-transgenic. Voluntarily labeled as non-transgenic.

MS. TUCKER FOREMAN: Products voluntarily as non GMO.

DR. SCHECHTMAN: Non GMO.

DR. LAYTON: You\'ve got to say transgenic.

MR. GIROUX: Meet me half way.

MS. TUCKER FOREMAN: No, but products voluntarily labeled as non \--

MR. CORZINE: Non transgenic.

MS. TUCKER FOREMAN: \-- transgenic.

MR. CORZINE: If I can insert while we\'re on this one. I think we should
pull organic products out of there because it tends to confuse. There
are a lot of people that use organic products and it really doesn\'t
have a lot to do with genetic engineering or GMO\'s and what I was
trying to get to on language, and rather than get to labeled
non-transgenic and what that means, I just inserted some specialty
markets have been developed to meet these needs.

DR. LAYTON: Some specialty markets or products?

MR. CORZINE: Markets. Some specialty markets.

DR. LAYTON: I don\'t think a market can do that.

MR. JAFFE: Well, I think the point is then that organic existed
beforehand. Organic was not a specialty market that\'s been developed to
meet this need.

MR. CORZINE: Right.

MR. JAFFE: It happens to be one that fulfills this need, but it wasn\'t
developed to meet this need.

MR. CORZINE: And it\'s not exclusive for what you just said, Greg.
That\'s my point. I don\'t think organic should be in there as the
example.

MS. TUCKER FOREMAN: You can say since organic \-- the organic world
prohibits the use of.

MR. CORZINE: Well, this is in our other AC21 members.

MS. DILLEY: Is that specialty products or specialty markets?

MR. CORZINE: It\'s the market that\'s been developed. You could call it,
I don\'t know.

MS. DILLEY: Markets of specialty products.

MR. CORZINE: Markets for specialty products in each market and if you
want to like that word.

DR. LAYTON: But consumers are avoiding the products. Are we eliminating
that part of the sentence?

MR. CORZINE: No. For consumers who want to avoid these products, that\'s
where some specialty markets or each market has been developed which
could include organic, but I don\'t want to name organic.

DR. DYKES: I\'m okay with what \--

MS. DILLEY: Each market \-- these markets have evolved to serve as
alternatives?

MR. CORZINE: Or have been developed I think does it.

DR. DYKES: Yeah. These markets have been developed.

MS. DILLEY: Have been developed period?

MR. CORZINE: Yes.

MS. SULTON: Then take off all this reference to labeling?

MR. CORZINE: Then take off \-- yeah, take that off.

DR. DYKES: That covers Randy\'s as well.

DR. SLUTSKY: Can we flip that around and say some specialty use markets
have been developed for those consumers who want to avoid?

DR. LAYTON: Sure.

DR. SLUTSKY: I mean, just because it\'s \-- it seems like the sentence
is complete.

MS. DILLEY: Okay. Randy, is your card still up or you have another
comment?

MR. GIROUX: No.

MS. DILLEY: Greg?

MR. JAFFE: A couple of things. On the first sentence, I would propose
deleting the first sentence in that discussion.

MS. DILLEY: Which first sentence?

MR. JAFFE: The first sentence in the discussion.

MS. DILLEY: In the explanatory text?

MR. JAFFE: Explanatory text.

MS. DILLEY: Okay.

MR. JAFFE: I mean, I don\'t think we have the sentence, but if we do,
deleting "as a result of the Internet and other new methods of mass
productions." I mean, mass \--

DR. LAYTON: Mass communication.

MS. DILLEY: You want to just take that sentence out now that we\'ve made
that the topic sentence on the second part of that paragraph? Can we
just drop it? Drop.

DR. LAYTON: Drop the first sentence?

MS. DILLEY: So, now it starts \-- I mean, because it already states that
there are different points of view so you just go right into explaining
what those different points of view are.

MR. JAFFE: Okay.

MS. DILLEY: Okay.

MR. JAFFE: Second minor one. This is in the other AC21 members, at the
end it says, these members \-- I guess what line it is. line 758. These
members also believe the majority of American consumers are primarily
interested in food safety and cost. If you want to say that, that\'s
fine, but I don\'t think that\'s the case.

I think people are most interested if you gave them, you know, if you
gave them Chinese, you know, discussing food for pennies (sic) and it
was safe I still don\'t think they would buy it. They buy things because
of taste, because of other things.

I think you\'re not capturing what consumers do there, but it\'s not my
section so it\'s a friendly suggestion, not condescending, and I think,
as a food manufacturer I don\'t think you\'re selling food safety and
costs. You\'re selling your particular brand, your taste, your special
food. But I\'m not in that group.

DR. DYKES: Why don\'t we just insert buyers of food safety, taste, and
cost, and let everything go?

MS. TUCKER FOREMAN: No, because if you get to say what you want the data
show now that convenience is more important.

MR. JAFFE: So now in the first sentence of the whole discussion my
proposal would be to say the first group thinks that consumers have a
fundamental right to know the origin of ingredients in their food.
Having that information allows those consumers to have a \--

MS. TUCKER FOREMAN: Have a right to know \--

MR. JAFFE: \-- fundamental right to know the origin of ingredients in
their food, period. Having that information allows these consumers to
\--

MS. TUCKER FOREMAN: Having it on the label?

MR. JAFFE: Yeah, I mean, you can put that.

DR. LAYTON: Having that information on the label.

MR. JAFFE: Allows those consumers \-- we have to get genetic engineering
in there. I haven\'t done that very well here, but having that \--
having information on the label about \--

DR. VAN EENENNAAM: Having information about genetic engineering on the
label?

MR. JAFFE: On the label allows those consumers to choose to purchase or
avoid.

MR. GIROUX: Having the information about the foods were produced from
genetic engineering.

MS. TUCKER FOREMAN: I have consumers have a right to know what is in
their food, but you\'ve said it kind of differently.

MR. JAFFE: If you want to take yours, that\'s fine.

MS. TUCKER FOREMAN: I know what you want to do and I think it\'s
important, but I suggest that maybe we should kind of make that sentence
if that\'s all the disagreement that we have.

MR. JAFFE: Okay. I want to get a concept of right to know in there at
the beginning before we get into the labeling of the genetically
engineered choice.

DR. LAYTON: Is there any changes you want? Because I heard you volunteer
to come back with a sentence you both can agree on.

MS. TUCKER FOREMAN: Yeah, at this stage that it\'s not worth taking the
group\'s time to try to crack the sentence unless there are other people
in this group who vigorously disagree.

DR. DYKES: That\'s one of the questions just, so, again, a friendly
question. Do you want any suggestion in addition to right to know or do
you want any suggestion about whether it would be detectable or not?
Just toss that out.

MS. TUCKER FOREMAN: That\'s a little more than. I think that it\'s
really basically \--

DR. SCHECHTMAN: Okay.

MS. TUCKER FOREMAN: We\'re going to do adventitious presence in four
other issues.

DR. LAYTON: Okay. We\'re almost there then.

MS. SULTON: Greg, with your change, do we then delete \-- does that
replace \-- does it end that way, to purchase or to avoid?

DR. VAN EENENNAAM: It can\'t end on avoid.

MS. TUCKER FOREMAN: We\'re going to leave that, but we need to go off
and write that sentence and try to save everybody else\'s time.

DR. LAYTON: Okay. We\'ll leave that until we hear from you. Okay.

MS. DILLEY: Alison, Kathleen, and then Mardi.

DR. VAN EENENNAAM: Is it me next?

MS. DILLEY: Yes.

DR. VAN EENENNAAM: I have kind of a big concern in that we have already
had a topic on genetic engineering of animals and ethical concerns and
there\'s quite a large section in here that really does talk about that
and it\'s inflammatory to me the way that it\'s written, and I\'m not
really sure of the relevance specifically of the topic of labeling and
it was certainly very, very changed from last time\'s draft and I\'m
very uncomfortable with the way it currently reads.

MS. TUCKER FOREMAN: In terms of being redundant, I would once again
refer you to the number of issues we have that discussed adventitious
presence. This is the point of view of this group and there\'s nothing
there that\'s not true and, you know, I would prefer not to have some of
the things that you have described in your views on some of these
issues.

MS. DILLEY: Is it possible to offer language \-- I mean, I think the
main point you\'re making in here, again, just language in trying to
find some way to do it, that transgenic animals is going to be able to
make exercising this choice even more important, I think, Carol, is
somewhat what you\'re saying because there are a variety of reasons why
people want to avoid these foods and labeling becomes even more of an
issue on products other than for safety reasons.

So, I don\'t know if there\'s a way to \--

DR. SLUTSKY: Condense?

MS. DILLEY: I don\'t know if it\'s not necessarily condense, but make
the same point, but slightly differently. So, it would be good if I had
language off the tip of my tongue.

DR. CRAMER: I have a way that we might be able to crack those.

MS. DILLEY: Okay. If you do have language. Okay.

DR. CRAMER: It might not be that hard. Unlike the first generation,
yada, yada, yada, future modifications may be more conspicuous or
controversial. For example, even if consumers, so, you sort of break out
that as an example among others, and that sort of dissipates \--

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

MS. DILLEY: They want to avoid \--

DR. CRAMER: Okay. So, I\'ll repeat that. You have the whole business
about used in animal feed or ingredients in processed food, future
modifications may be more conspicuous or controversial. For example,
even if consumers accept that genetically engineered animals are safe.

MS. SULTON: I\'m a little confused about where you\'re starting so if
you\'d tell me that, please.

MS. TUCKER FOREMAN: Starting with unlike the first generation of
products.

DR. LAYTON: That have been largely invisible.

DR. CRAMER: Okay. Remove such as transgenic animals will in some
instances be. What did I say there? May be more conspicuous or
controversial.

MS. TUCKER FOREMAN: I\'d be willing to drop conspicuous and just have
may be more controversial.

DR. CRAMER: Fine with me.

DR. LAYTON: Would you be willing to drop conspicuous and just be may be
more controversial? Okay.

DR. CRAMER: And then the beginning of the next sentence, even if, strike
that sentence by for example. So, does that help your issues out?

DR. VAN EENENNAAM: I still feel that helps. The altering of that
sentence I think is kind of inflammatory language.

MS. TUCKER FOREMAN: That\'s what happens and I\'m not prepared really
to, you know, take that out, the impression about our views, and I\'m
willing to accept Carole\'s modifications there, but I just don\'t think
it\'s reasonable to ask that \-- that\'s a factual statement. That\'s
why people object.

MS. DILLEY: Alison, if you have alternative language, I don\'t know. I
mean, I don\'t know alternative to sentient beings.

DR. LAYTON: Okay. Anything else other than that you two are going to
finish that one sentence? Leon has something.

MS. DILLEY: I think Kathleen was next and then Leon.

DR. LAYTON: Oh, sorry. Kathleen.

DR. JONES: With regard to requiring labeling, you might want to mention
that it likely will require new legislative involvement.

MS. TUCKER FOREMAN: No, because we didn\'t say it with regard to the
regulatory statement.

MS. DILLEY: Okay. Leon?

MR. CORZINE: The first sentence under other AC21 members, I would offer
other AC21 members believe, strike that while, and then go on with
consumer interest.

MS. DILLEY: Consumer interest?

MR. CORZINE: Consumer interest and then you strike everything to the
next interest and you include is not, strike primarily.

MS. DILLEY: So, interest is primarily?

MR. CORZINE: Interest is not focused. Consumer interest is not focused
on whether food products are derived through agricultural biotechnology
or contain genetically modified ingredients.

MS. DILLEY: Okay.

DR. VAN EENENNAAM: Modified or engineered? Are we using modified?

DR. SCHECHTMAN: Genetically engineered, no.

MS. DILLEY: Genetically engineered, yeah.

MS. TUCKER FOREMAN: I just want to be sure I had that. Consumer interest
is not primarily focused?

MR. CORZINE: Is not focused.

MS. TUCKER FOREMAN: Okay. Is not focused.

MS. SULTON: You want primarily out?

DR. LAYTON: Yes.

MS. DILLEY: Yeah.

MR. CORZINE: I had one question also on the other. I question, aren\'t
there any products from biotechnology that are directly used in food?
Because one group says it isn\'t.

MS. TUCKER FOREMAN: Where are you?

MR. CORZINE: The sentence you were just working on, on yours.

DR. CRAMER: What was your question?

DR. LAYTON: It\'s the largely invisible.

MR. CORZINE: The largely invisible because.

DR. LAYTON: They\'re used in animal feed.

MS. DILLEY: You want to take largely out?

MR. CORZINE: No, I\'m just questioning where it said \-- where to go,
I\'ve lost it now. This question of fact.

DR. CRAMER: Yeah, you can have a transgenic papaya.

MR. CORZINE: That\'s my point. This says that there are none.

DR. VAN EENENNAAM: I have no idea where we are.

MS. DILLEY: It\'s up in that largely sentence.

MR. CORZINE: It\'s says in the language invisible because the animal \--

MS. TUCKER FOREMAN: Largely invisible.

MR. CORZINE: Uh-huh, largely. Unlike the first generation of products
that have been largely invisible because they\'re used as animal feed.

DR. LAYTON: Okay. Were primarily used as animal feed.

MR. CORZINE: Unlike the first generation of products that have been
largely invisible because they\'ve been used as animal feed or
ingredients in processed food. The future \-- animal feed or
ingredients.

MS. TUCKER FOREMAN: May I suggest something that might make you \-- that
virtually all are used as animal feed or ingredients, that would qualify
for papaya and squash, which I think are so minute in terms of the food
consumed by Americans that they almost don\'t count, but if you want to
say virtually all, that\'s fine.

MR. CORZINE: I think you should put something because there are some
people, some consumers, I think, where it\'s very important.

DR. LAYTON: Okay. So, unlike the first generation of products that were
virtually all invisible.

MS. TUCKER FOREMAN: No, no.

DR. LAYTON: Okay. Sorry.

MS. TUCKER FOREMAN: Virtually all are used as animal feed or
ingredients.

DR. LAYTON: So, before used. They are virtually all used.

MS. TUCKER FOREMAN: They\'re largely invisible because virtually all are
used as.

DR. LAYTON: Okay. So, we\'re there?

MS. DILLEY: Mardi?

DR. MELLON: One little tiny thing. I think on line 736 that we say meat
and milk \-- milk and meat rather than milk and hamburger. I don\'t
know.

MS. TUCKER FOREMAN: I\'m sorry, I meant to grab that.

DR. LAYTON: We were all sitting there figuring out why hamburger.

MS. TUCKER FOREMAN: Yeah.

DR. LAYTON: Okay. Lisa and Russ, Abby, while you were looking around.

MS. DILLEY: Russell and then Lisa.

MR. KREMER: Yeah. Just on the first group, I just had a strong
preference to that including the word mandatory when we\'re talking
about labeling. I don\'t see it in there and I\'ve been working with
other labeling issues and it gets misconstrued that you say labeling
when it\'s just a voluntary labeling system, so, keep that in mind.

DR. LAYTON: Well, we added the word mandatory at the bottom of that
page. Did that help?

MS. DILLEY: We put mandatory in there, but I\'m not sure if we \-- do
you have a particular reference point?

DR. SCHECHTMAN: They\'re working on the first sentence.

DR. DYKES: Mandatory is supposed to be between believe and labeling.

DR. SCHECHTMAN: Right.

DR. DYKES: Put mandatory both places.

DR. SCHECHTMAN: There was something else that was going to happen on the
first sentence and make sure that \--

MR. KREMER: That was my point.

DR. DYKES: Russ is that group. Russ and Carol and Greg.

DR. LAYTON: Okay.

MS. DILLEY: Lisa.

MS. ZANNONI: Well, I have kind of a factual thing. The thing about milk
and hamburger.

MS. DILLEY: It\'s meat.

DR. VAN EENENNAAM: Milk and meat.

MS. ZANNONI: This is the milk and meat of genetically engineered
products? I\'d say these are farther \-- the animals are going to be \--
there\'s going to be a few generations before we have plants coming
before we \--

MS. TUCKER FOREMAN: It just says future modifications.

MS. ZANNONI: We don\'t have next generation?

DR. SCHECHTMAN: 734.

DR. LAYTON: In addition.

MR. CORZINE: Some of the next generation.

DR. LAYTON: Some of the next generation of genetically engineered
products.

MS. ZANNONI: Can we just put period?

MS. TUCKER FOREMAN: Say it how you\'d like it, Lisa.

MS. ZANNONI: Well, 734 it says, in addition, these members believe that
consumers are more likely to be uncomfortable with or opposed to some of
the next generation of genetically engineered products. I\'d just put
period there.

MS. TUCKER FOREMAN: I think I\'d rather say to some future genetically
engineered products, especially milk and meat, because that\'s truly the
place where a large rub will come.

DR. LAYTON: So, we\'re replacing of the next with the word future.

DR. SCHECHTMAN: Some future.

DR. LAYTON: To some future generation of genetically.

DR. SCHECHTMAN: No generation.

MS. TUCKER FOREMAN: Some future genetically engineered products.

DR. LAYTON: Especially milk and hamburger. Milk and meat from
genetically engineered products.

MR. GIROUX: Can you say derived from transgenic animals?

MS. TUCKER FOREMAN: Yes.

MS. ZANNONI: Yeah. Derived from.

DR. VAN EENENNAAM: It\'s hard to get it otherwise. MS. DILLEY: Okay.
Were there any other comments on Lisa\'s?

DR. LAYTON: Okay.

DR. VAN EENENNAAM: I guess I don\'t know how to resolve this, but I\'m
still uncomfortable with sentient beings and I guess can it be religious
objections to the genetic engineering of animals?

MS. TUCKER FOREMAN: The reason that it\'s objectionable is that people
are uncomfortable about altering sentient beings. People are not very
uncomfortable with altering plants. I talk to my plants but they don\'t
talk back.

MS. ZANNONI: Because the point is labeling or not so we already have
this when the point is about animals, about why, but can you just \-- do
you have to put why they have objections?

MS. DILLEY: It\'s just an elaboration of the moral point or you\'re
trying to avoid?

MS. TUCKER FOREMAN: I\'m trying to avoid the point. It\'s not incorrect.
It\'s factually correct. It is argued and unless some of the people who
are in that group object I think we ought to leave that sentence there,
or, I would like to go back and alter amendments to some of the things
that were expressed in \--

MS. DILLEY: I don\'t think people want \--

MS. ZANNONI: If it\'s correct, if it\'s on point with what the issue is,
since the issue is labeling, t hat\'s what this issue is, and your
stance is you label so that people can avoid. So, you\'re making the
point that \--

MS. TUCKER FOREMAN: I\'m saying why do they want to avoid.

MS. DILLEY: Right, and I think it\'s just \-- it\'s not trying to change
the facts, Carol. From what I\'m hearing, it\'s more the discomfort with
the terminology of altering sentient beings which we haven\'t talked
about before and that seems a little bit something more, from what I\'m
understanding you saying, Alison, than genetically engineered animals
which is \--

MS. TUCKER FOREMAN: Again \--

MS. DILLEY: Such animals? But I don\'t \-- that\'s not quite getting to
your \--

MS. TUCKER FOREMAN: The problem arises \-- almost nobody has a moral or
ethical objection to altering corn. People do have moral objection to
altering cows.

DR. LAYTON: Right, and what I think she said was that they can have a
moral or religious objection to altering animals. She just didn\'t like
the sentient beings. And I actually have to say, Carol, that in this one
I\'m actually with animals and I\'m with you. I have a moral, a
religious objection to altering \-- it\'s more than sentient beings. I
mean, I go a little bit further than that and I\'m in your camp on this
one.

MS. TUCKER FOREMAN: Sentient \-- I mean, that\'s like you don\'t want to
do animals. They\'re sentient beings.

DR. LAYTON: But where does the sentient being start?

MR. CORZINE: What\'s the difference?

DR. LAYTON: I don\'t know.

DR. DYKES: Well, I don\'t think we have to do it, we have to determine
it. I think where Carol\'s coming from clearly it starts in animals so
the methodology she\'s talking about there, so, it\'s covered with
animals.

MS. TUCKER FOREMAN: I\'m saying though that I\'m not really prepared to
drop the term sentient beings.

DR. DYKES: That\'s what I\'m saying, you\'re not because you\'re talking
about animals, you don\'t have to define it. You\'re talking about
animals then clearly stipulate it.

MR. CORZINE: What might help is, Carol, could you define that?

DR. LAYTON: What is a sentient being?

MR. CORZINE: What is it?

MS. TUCKER FOREMAN: It\'s a being that is able to think and respond. If
you\'d like, I\'ll get the definition off my computer if that would make
people feel better.

MR. CORZINE: It might. I don\'t know.

DR. LAYTON: It might, Carol.

MS. TUCKER FOREMAN: It\'s not an inflammatory term. It is a term that is
used in the literature.

DR. LAYTON: But it also seems to be very broad.

DR. SCHECHTMAN: Carol, I don\'t know if this form will satisfy you, but
as a thought of saying higher animals. Does that address \--

MS. TUCKER FOREMAN: This is probably like saying sentient.

DR. CRAMER: The other thing I\'d like to bring up is that it says \-- it
doesn\'t say engineered. I mean, reading all the sentient beings all the
time. We\'ve reboxed \-- this is a significant \--

MS. TUCKER FOREMAN: Genetically engineered sentient beings.

DR. CRAMER: Yeah, so, I think we should say at the genomic level or
something like that.

MS. DILLEY: It\'s genetically engineered?

DR. VAN EENENNAAM: It\'s not the genetically engineered part I have a
problem with, it\'s the sentient being part.

MR. GIROUX: What is sentient being to mean? What\'s your definition of a
sentient being?

DR. VAN EENENNAAM: Well, I think a sentient being to me brings up an
image of a human the way I consider sentient beings and I just think if
it\'s animals we\'re talking about.

DR. LAYTON: Animals are human also. I mean, I kind of \--

MR. CORZINE: Well, the thing is, since there is direct linkage to a lot
of people it becomes inflammatory.

DR. VAN EENENNAAM: And I do think also there are certain people that
have actual objection to engineering plants as well so I don\'t know
that we can say that for any animal has a moral or ethical objection,
including people who think firmly about plants.

MS. TUCKER FOREMAN: But the numbers are really quite small and on one
hand and say to be very large in the other.

DR. DYKES: I still think too, to me, this is when you have some members
and then other members. To me, other members should be able to say what
other members feel as long as it\'s not blatantly inaccurate. If it\'s
accurate and they feel that way, I\'m of the opinion that they should be
able to say what they feel and when we start with some members and other
members then, to me, the two or three camps can say what they want to
say.

MS. TUCKER FOREMAN: The sentient is conscious.

MS. DILLEY: You mean so altering consciousness.

MS. TUCKER FOREMAN: Yeah. I think it\'s not just \-- it\'s meaningful in
this case. I will get on my other computer.

DR. SCHECHTMAN: Carol, do sentient animals work for you?

MS. TUCKER FOREMAN: Yeah.

MS. DILLEY: Sentient animals.

DR. LAYTON: Sentient animals.

MS. DILLEY: Great. That\'s okay. Okay.

(Discussion off the record)

MS. DILLEY: Can we take a break, like five minutes, stretch your legs.

(Discussion off the record)

MS. DILLEY: When we come back we\'ll take on topic 19.

(Whereupon, a brief recess was taken)

DR. LAYTON: We have twelve to do and one hour left before we start
losing people. Most of these we think are very easy. Please be sure that
you have substantive issues so we can make it through this.

MS. DILLEY: What time are we missing people?

DR. LAYTON: 3:30, we have the first wave for 5:00 flights. Okay. We\'re
taking away the note, but just to know Daryl Buss and Carole Cramer,
after a conference call, wrote the lines in italics as a result of that
conference call.

DR. DYKES: It\'s on page 18.

MS. DILLEY: Page 18, right, the topic 19.

DR. DYKES: Page 19.

DR. LAYTON: Are we trying to delete including floriculture or do we want
to include floriculture?

MS. SULTON: Are we talking about the topic sentence or are we in the
text?

DR. LAYTON: I\'m in the text.

DR. CRAMER: That terminology was provided by Michael from some official
document?

DR. SCHECHTMAN: Yes.

DR. LAYTON: And the bracket is \--

DR. SCHECHTMAN: The bracket is in the official document.

DR. LAYTON: Okay. Then read it. It is in quotes and footnoted.

(Discussion off the record)

DR. DYKES: I would suggest we drop \-- I like what Michael suggested. I
suggest we delete starting with federal agencies.

MS. DILLEY: Yeah.

DR. DYKES: And leave it one view. Maybe I take too much away. I don\'t
know.

MR. JAFFE: If you drop something else, I think would be helpful. Costs
of regulatory compliance, which is on line 650.

DR. DYKES: What do you say, Greg, take out costs of regulatory
confinement is the other one?

MR. JAFFE: Fine.

DR. DYKES: And drop federal agencies on and then we don\'t need some
think, others think?

MR. JAFFE: From my perspective, yes.

MR. GIROUX: You don\'t think the cost of regulatory compliance?

MR. JAFFE: No, they\'re not a unique factor to specialty crops. I mean,
Keith, what\'s his name, Redenbaugh or the guy from \-- \-- told me on
numerous occasions it\'s not the cost of regulatory compliance that has
been keeping him from marketing \-- commercializing and marketing
transgenic crops. So, I am uncomfortable with that.

I\'m also just uncomfortable with the concept of these all things being
factors. I guess, I propose to leaving those four words, but my other
comment is that I think these are reasons.

I would like to change those factors to reasons and the reason is we\'re
talking about these factors and then we sort of say that these factors
must be addressed, okay, and I don\'t know, how does one address small
market size of a specialty crop? Are we going to try and make the
markets bigger for that specialty crop? Are there containments for
farmers to grow that specialty crop?

DR. DYKES: How about these factors must be considered?

MR. JAFFE: And then another one. How does one address the unique or
individual biological characteristics of a crop? So, I think we\'re
identifying reasons. And, so, I think we should change it to reasons and
then we shouldn\'t say \-- I\'m objecting to somehow these factors,
these reasons have to be addressed. Some of them aren\'t addressable.
There are just reasons for it. There may be ways around them or other
things that can be done.

MS. DILLEY: Okay. So, the language is?

DR. DYKES: How about considered instead of addressed? These reasons must
be considered.

MS. TUCKER FOREMAN: That sounds like a recommendation to me.

DR. DYKES: Or reviewed. How about dropping that sentence as well?

MR. JAFFE: The only problem with that sentence is if issues surrounding
it are perceived to warrant the application of modern biotechnology. I
didn\'t know what we meant by issues there.

DR. LAYTON: All right. Let\'s drop that sentence and see how it reads.

DR. DYKES: Drop that sentence then.

MR. JAFFE: That\'s fine.

DR. DYKES: That should help it.

MS. TUCKER FOREMAN: That\'s okay.

DR. DYKES: It needs to be dropped. We had it in the topic sentence.

MS. DILLEY: Okay. So, then what we have is although many specialty crops
would potentially benefit from modern biotechnology derived innovation
and then those reasons include, but are not limited to, the small market
size of specialty crops, the costs of access to intellectual property,
unique individual biological characteristics of specialty crops, blah,
blah, and the period and then that\'s it.

DR. DYKES: We say multiple factors when we say those reasons.

MS. DILLEY: I thought we changed that to those reasons include. Oh, I
see, factors.

DR. DYKES: Those factors, we\'re referring back to the previous sentence
where we said limited to multiple factors.

MS. DILLEY: Multiple factors, right. So, is it multiple reasons or is it
consistent with reasons or consistent with factors?

DR. DYKES: Multiple reasons. Those reasons.

DR. LAYTON: She\'s got it.

DR. DYKES: In my mind I don\'t see a big difference, but I\'m fine
either way. Greg, you\'d rather have reasons.

MS. DILLEY: Okay. So, reasons.

DR. DYKES: We\'d rather have reasons. Multiple characteristics.

MS. DILLEY: Multiple characteristics? Okay. Because it\'s in the topic
sentence so now we\'re really being consistent. Okay.

DR. LAYTON: Could I offer just a question for Greg on the cost of
regulatory compliance? Is it sort of the percentage \-- it\'s not the
cost of regulatory compliance is any different for that crop than in
other crops, but is it that it\'s such a percentage, a higher percentage
of recouping the cost, the cost of that to be recouped? Is there a way
to say that? The proportional costs.

I just wanted to know if there\'s a way to say that.

DR. DYKES: I don\'t think the biggest constraints is the size of the
market size.

MR. JAFFE: The people I talk to in the industry don\'t say the reason
that they\'re not marketing these is because of the cost of getting it
through the regulatory system. There are all these other things.

DR. DYKES: It doesn\'t get that far.

MS. DILLEY: So, take it out.

MR. JAFFE: But it\'s used all the time as an excuse.

DR. DYKES: I would just say from our perspective it\'s a consideration.
But we do consider it all the time because you got to think about where
you\'re going to launch it and how many other countries you\'ve got to
get approval for and the expense of that and does the market size
warrant doing that.

DR. LAYTON: Yeah. It\'s in relation to market size. It\'s the cost of
regulatory approval and relation to the market.

DR. DYKES: It is. You can\'t get approvals in 30 countries and you
market on 1,000 acres. You can\'t do it.

DR. SLUTSKY: It\'s not the absolute cost of regulation. It\'s the cost
of regulation in relation to \--

DR. LAYTON: Market size.

DR. DYKES: It\'s a part of product development.

DR. LAYTON: Okay.

DR. SHURDUT: It\'s a return on investment.

MR. JAFFE: If you want the return on investment I\'m happy with that.

DR. DYKES: Yeah.

DR. LAYTON: I\'m just saying, is there a way to put it in?

MS. DILLEY: I don\'t know, what language is it?

DR. DYKES: I would put return on investment.

MR. GIROUX: That\'s what it really is.

DR. DYKES: That\'s what it really is.

MR. GIROUX: You\'ve got a certain period of time, you\'ve got to pay it
off.

MS. DILLEY: What is return on investment?

DR. DYKES: Replace the cost. Replace that with return on investment.

MS. ZANNONI: Can we change compliance to approval?

MS. DILLEY: No, we have compliance in there. We have return on
investment. Access to intellectual property, return on investment,
unique individual and biological. That\'s how it reads now?

DR. DYKES: Acceptable return on investment.

MS. DILLEY: Acceptable return.

DR. DYKES: On investment. That takes in the regulatory costs, the food
ship costs, all the other things important to the market.

DR. LAYTON: Is it costs of access to intellectual property or just
access to intellectual property? Because the return on investment piece
is going to take care of the cost of that.

DR. DYKES: I would agree with that because it may just be that you
can\'t get it even if you\'re willing to pay for it.

DR. LAYTON: Okay. So, now it reads limited to the small market size of
specialty crops, access to intellectual property, acceptable return on
investment, unique or individual biological characteristics of specialty
crops, the dynamics of the marketplace and other commercial challenges.
And we\'re fine?

MS. TUCKER FOREMAN: No.

MS. DILLEY: Carol?

DR. LAYTON: Carol\'s not fine.

MS. TUCKER FOREMAN: No. First, I think \-- I\'m sorry, I just had to
stand up to be able to see it. On number 6, I don\'t know, the term
specialty crops could potentially benefit. Either the producers of
specialty crops could benefit or the public could benefit because these
crops have something special to offer as we determined in number 6.

There has to be \-- crops are not sentient. If you want to say producers
of specialty crops could potentially benefit we\'re saying that, at
least we were originally saying that we are going to change things; no
authority structures, other issues in order to benefit those producers
and \--

DR. LAYTON: We dropped all that.

MS. TUCKER FOREMAN: So, how does it end?

MS. DILLEY: At the end of commercial challenges, period.

MS. TUCKER FOREMAN: I\'m sorry. Those reasons include, but are not
limited to.

DR. LAYTON: So, what I think I heard you say, Carol, was the public may
benefit from genetic engineering of specialty crops.

MS. TUCKER FOREMAN: No. I said producers of many specialty crops could
benefit, potentially benefit by adopting modern biotechnology derived
innovation.

DR. LAYTON: Okay. Producers of specialty

crops \--

MS. DILLEY: She has a point in terms of it\'s not crops that are
benefitting, it\'s trying to qualify who.

DR. CRAMER: Yeah, I think the public.

MR. SLOCUM: Slow-ripening apples.

MS. TUCKER FOREMAN: Then in order to do that we have to, and I don\'t
think it does it on this one, does it have the definition of what they
are?

DR. LAYTON: Yes, it does, legally. It\'s quoted from public law.

MS. TUCKER FOREMAN: All right. Then I will go with the public.

DR. LAYTON: Could benefit from modern biotechnology innovation in
specialty crops.

MS. TUCKER FOREMAN: Okay. I think I\'m okay with the \--

DR. LAYTON: Of specialty crops.

MR. CORZINE: We\'ve already got specialty crops there.

DR. LAYTON: The public could benefit from modern biotechnology derived
innovation in specialty crops. The extent of commercialization of
transgenic specialty crop is current.., but the extent of
commercialization of transgenic specialty crop is currently limited by
multiple factors \-- reasons.

MS. DILLEY: Characteristics because it makes it consistent with the
topic sentence.

DR. LAYTON: Okay. These reasons or these characteristics? These
characteristics include.

MR. CORZINE: Carol \--

MS. DILLEY: Can we wait until we make sure we\'ve got the language?

MR. CORZINE: I understand. Carol, to your point, because I agree with
you. I think we were \-- it might infer that we wanted regulations
reduced, right?

MS. TUCKER FOREMAN: Right.

MR. CORZINE: Because we don\'t want that.

DR. LAYTON: It\'s not all the provisions \--

MR. CORZINE: We didn\'t want any shortcuts.

MS. TUCKER FOREMAN: Yeah. Leon, I have another concern that I think that
we\'ve taken care of it. I have a hard time when the government picks
winners and losers by choosing to invest resources here and not there.
That\'s really addressed in this case by saying, as it was in number 6,
you\'re going to help produce things that are having public benefit and
in that case I can be okay with it.

MS. DILLEY: Alleviate that. So, I think if we\'ve got the language or
whatever. Ron?

MR. OLSON: Well, let\'s take a different tactic. I understand what
Carol\'s saying about public, but can you define what that is or is that
in separate terms? How about saying, using biotechnology in specialty
crops could generate benefits.

MS. TUCKER FOREMAN: That\'s okay with me.

MR. OLSON: You don\'t need the word public in there.

MS. TUCKER FOREMAN: For producers and consumers would be okay with me.

DR. CRAMER: But there\'s also the public. I mean, some of these things
will be targeting environmental issues which is a public benefit. It\'s
not just the consumer.

MR. OLSON: We need to spell it out. Is public enough to capture that?

DR. CRAMER: I think so.

MS. TUCKER FOREMAN: That\'s okay.

DR. CRAMER: Public benefit.

MR. OLSON: Okay. That was a little question mark.

(Discussion off the record)

MR. GRANT: Who is the public?

DR. LAYTON: Everyone is public.

DR. CRAMER: But would Carol feel as happy if the only person to benefit
would be Monsanto?

MS. TUCKER FOREMAN: Yeah, because in that case \-- well, it depends. If
we\'re going to invest public resources to get there I have a problem
with the government picking winners and losers and using public funds if
it\'s going to have a narrow benefit as opposed to a wide benefit.

DR. LAYTON: But we\'re not doing that. Okay. Carol, are we comfortable?

DR. CRAMER: It\'s a quote.

DR. LAYTON: It is a quote. The point though is the paren after the
footnote?

DR. SCHECHTMAN: No.

DR. LAYTON: is the parentheses \--

DR. SCHECHTMAN: No, the parentheses is in the quote.

DR. LAYTON: Is in the quote, inside the quote.

MS. DILLEY: Take out the \--

DR. LAYTON: Yeah, I think that parentheses goes away. I\'m sorry. Okay.
Fix that.

(Discussion off the record)

DR. LAYTON: Okay. I\'m sorry. I missed the parentheses. Everyone, moving
on to \-- we didn\'t get it all?

MS. DILLEY: No.

(Discussion off the record)

DR. LAYTON: And as I remember correctly, this is the benefit piece that
we moved from the introduction into the issues, right?

MS. DILLEY: So, 20 is 20. So, take a minute to read it, page 20, topic
20.

DR. SCHECHTMAN: And on page 15 on the colorful version.

(Discussion off the record)

DR. LAYTON: Abby has proposed on the colored version a few changes. I
assume those were all that came in on the commentary.

MS. DILLEY: Yes. I did not deal with them by myself.

DR. LAYTON: Okay. Are there bigger issues?

MS. TUCKER FOREMAN: Yeah. You know, I think this one doesn\'t belong in
here. It\'s not an issue.

DR. LAYTON: It may not be an issue, but we all agreed at our last
meeting, and I believe we had total consensus on this, that we would
pull it out of the introduction and we would put it in as an issue and
that we all agreed to that at that point.

MS. TUCKER FOREMAN: I don\'t think that I did and it really does bother
me to have it as an issue. If other people have \-- it doesn\'t read
like the others. And we had this discussion in any one of the telephone
conversations about it where I said very strongly that I don\'t think it
is and I submitted that in the other comments.

It may be that we make it work so that it is, but it\'s not.

MS. DILLEY: This has always been an additive. I don\'t think we\'ve ever
deleted a topic and that we talked yesterday about \-- so, let\'s see if
we can find language and edit the language.

MR. GRANT: I would suggest going to the colorful version as a place to
start. I think the colorful version is a place to start on the language.

DR. CRAMER: I would also like to just remind people what happened in
that last phone conversation. There was a lot of discussion back and
forth and what we did was really change sort of the meaning of this to
capture something that hadn\'t been articulated quite that way before
which was the concept that because the benefits of producers are
significant they\'re actually a factor as a driver for wanting more of
these biotech things in development and in the pipeline.

And that became sort of one of the points that we want to make to the
Secretary is that interest; that because of the advantages of being able
to manage pests there is \-- there may not be a consumer pull, but
there\'s producer pull, that would continue to play into how things go.
And, so, if we read the topic sentence I think that that\'s very
different from what previous versions said and putting in that it\'s a
driver.

MS. DILLEY: Duane, were you \-- did you have your card up?

MR. GRANT: No. I agree with what Carole just said, so, she said it well.

MS. DILLEY: Okay. Greg and then Ron.

MR. JAFFE: I was not on that conference call. It wasn\'t the group that
I was assigned to or couldn\'t make it so I was not aware of that. I
guess I had a question about the topic sentence because there is a link
being made here that\'s not been discussed at all in the discussion
section and I don\'t know what the basis for that link is.

MS. DILLEY: Okay. So, say the link and then let\'s get it out.

MR. JAFFE: The link that farmer demands is the driver for continued
development of agricultural varieties derived from modern biotechnology.
I mean, I don\'t know if farmers want Omega-3 genetically engineered
corn with Omega-3. That\'s the next thing that\'s coming down
Monsanto\'s pipeline. So, I don\'t see that link.

DR. SHURDUT: But it\'s a driver, not the only driver.

MR. CORZINE: I would say yes, Greg.

MR. JAFFE: But I think that if that\'s to stay in, I think you have to
have some discussion in the discussion about that because there\'s no
discussion in the discussion. All the discussion discusses is a
reiteration of benefits. So, I guess, I didn\'t see the link so I
suggested deleting it from the topic sentence.

I\'m happy to keep it in, but then there\'s got to be some discussion
about what is the link there or what\'s the point there.

DR. DYKES: Isn\'t that on line 626, 27, and 28? That whole sentence is
going to farmers and the prospects and that is the link to the topic
sentence.

MS. DILLEY: You\'re looking at the colorful document right now, because,
Duane, I think your addition may help clarify that, but I don\'t know.

MR. GRANT: Right. I submitted suggested edits as part of the process
which are picked up now in this colorful document because of the need
for a clearer link between the issue statement and producer demand.

MR. JAFFE: I guess I have \-- I mean, that last sentence, I have this
major question. I mean, is that some farmers grow irrespective of market
signals? I mean, farmers are smarter than that. If there\'s no market
for something, why are they going to grow it? And, so, I mean, to me, I
suggested deleting that second half of the sentence because I just \-- I
don\'t understand how \-- why people who do things that go against the
market.

MS. DILLEY: I see. They\'re nodding, so \--

MR. CORZINE: I was saying, I was right there, Greg. I put a period after
containing new traits.

DR. LAYTON: Period. Full stop.

MR. JAFFE: Well, then I still don\'t see how this makes a link.

DR. VAN EENENNAAM: Can we finish that sentence with trait and this
continues to be a driver for the development of new crops or something
like that to tie it back to the topic sentence?

DR. LAYTON: And this demand will drive the development of new \--

DR. VAN EENENNAAM: Other new traits.

MR. JAFFE: I think other new traits right there.

MS. DILLEY: Drive what?

MR. GRANT: Then you go off on the new traits.

MS. DILLEY: That have development of new traits.

DR. VAN EENENNAAM: New traits.

MR. JAFFE: That helps me.

MS. DILLEY: That helps?

MR. JAFFE: Yeah. Although now, my other comment on the topic sentence, I
have some comments on the topic sentence. One is, I don\'t \-- I still
don\'t see any discussion of indirect benefits. I see discussions of
direct benefits and, so, I still \-- if we\'re going to say something
about indirect benefits I think we have to define what we mean by
indirect benefit and then we need to do that.

And, secondly, I think that this makes it clear to me, based on the
second half of the topic sentence we just added, that really here we\'re
talking about farmer benefit traits and we should be saying that
providing direct benefits to farmers because we\'re not talking about
other parts of the food and feed chain.

DR. LAYTON: That\'s the production segment of the food chain.

MR. JAFFE: Well, I think farmers if that\'s what people understand.

DR. LAYTON: How about because farmer benefits. Because benefits have
been delivered to the farmer.

MR. GRANT: Just delete direct and indirect and just say \--

DR. DYKES: Take out direct and indirect if that\'s a problem.

MR. JAFFE: By providing benefits to farmers.

DR. LAYTON: Take direct and indirect out.

MS. DILLEY: Their demand for new benefits?

DR. LAYTON: No, not benefits. Just direct and indirect.

UNIDENTIFIED FEMALE: How about benefits to farmers?

MR. GRANT: This is not just farmers either. Benefits provided to
production side of the food and feed chain. It\'s not descriptive
research.

DR. LAYTON: Right. And I\'m comfortable with this. Can you be
comfortable this way?

MR. JAFFE: Well, you have to explain what those other \-- I don\'t see
any benefits here for other \--

DR. CRAMER: Well, if you\'re a farm worker and you\'re being exposed to
a pesticide that\'s a real benefit. I mean, if you\'re a minor worker
you\'re not \--

MS. DILLEY: Ron?

MR. OLSON: If you\'re a grain grower or a processor you can reduce
mycotoxin intake in corn through biotechnology, if we have more
consistent crops based on insect resistance, those types of traits.

DR. CRAMER: Or even quality issues.

MR. OLSON: Quality issues.

MS. DILLEY: Ron, did you have language you can suggest?

MR. OLSON: Let me state it slightly different. I would rather state the
issue, not the reason first. I would rather start the topic sentence,
farmer demand, and I had, for some, new benefits has become a driver for
continuing development. I mean, that\'s the issue is the farmer demand
has become a dragger for continuing development. You can add because if
you want to.

DR. LAYTON: Or you could leave it off.

MS. TUCKER FOREMAN: Farmer demand for additional benefits?

MR. OLSON: I\'d put some new benefits, but it could be additional
benefits \--

MR. CORZINE: Farmer demand for.

MR. OLSON: And additional. I\'d rather start the sentence with farmer
because that\'s the issue we\'re trying to quote is there\'s a push from
the farmer\'s side to get more of this stuff.

MR. CORZINE: Would it be demand for new traits or new products?

MR. OLSON: Yeah, if.

MR. CORZINE: Because of benefits.

MR. OLSON: That\'s right.

MR. CORZINE: Or to provide benefits. It\'s demand for traits.

MS. TUCKER FOREMAN: Farmer\'s demand for additional benefits such as.

MR. CORZINE: No, I think I would put new products or traits.

DR. LAYTON: For additional traits.

MR. OLSON: The issue isn\'t the demand, it\'s become a driver. That\'s
the issue. It\'s a non-traditional trait.

MR. GRANT: There\'s really two issues, Ron. So, I like how you\'re
going, but there really are two issues. There\'s the new demand issue
and there is the issue that the demand is strong and really will provide
the pull to bring new products to agriculture because producers have
realized significant benefits from the first generation of technologies.
That\'s really, I think, what this issue is all about is we recognize
that there have been significant issues and, so, we are pulling for new
products.

So, whether \--

MS. DILLEY: So, isn\'t that farmer demand for additional benefits has
become a significant driver for development of new traits?

MR. GRANT: Uh-hmm.

MS. DILLEY: I mean, doesn\'t it get both here?

DR. LAYTON: We have it derived from.

MS. TUCKER FOREMAN: I mean, that\'s the topic sentence.

MR. CORZINE: Well, I\'d say the farmer demand is for the new traits or
new products because of the benefits.

MS. DILLEY: I see what you\'re saying.

MS. TUCKER FOREMAN: Farmer demand for additional benefits.

MR. CORZINE: Well, you always have \-- no, I would put it \--

MS. DILLEY: The demand for additional traits.

MR. CORZINE: I like how it is up there better.

MS. DILLEY: Okay.

DR. LAYTON: Derived from biotechnology or dropping that?

MS. TUCKER FOREMAN: Where did we get our drivers? Has become a driver.

DR. MELLON: I don\'t understand what a driver is. I mean, why \--

MS. TUCKER FOREMAN: Stimulates.

DR. MELLON: Why \-- it has become a driver? Haven\'t farmers always
demanded these benefits from the \-- I don\'t \--

MS. DILLEY: No, I think Duane\'s saying that if \--

DR. CRAMER: I mean, if somebody is sitting there using the advantages of
no-till because they\'ve done this in soybean, I mean, they see that
this would be very useful.

DR. MELLON: So, the essence of this is that the realization of benefits
has increased farmer interest and in new applications of biotechnology
or something like that.

DR. LAYTON: Farmers have realized benefits and now demand \-- and demand
new traits or products.

MR. CORZINE: I would take some out of there. Farmer demands.

DR. LAYTON: Farmers have realized benefits from genetically engineered
crops. I don\'t know.

(Discussion off the record)

MR. OLSON: Go back to the original sentence and I think it already says
that.

DR. LAYTON: Okay.

MR. OLSON: Just put the because at the end instead of the beginning.
Just reverse the sentence. Just put the because at the end instead of
the beginning.

DR. LAYTON: Okay.

MS. TUCKER FOREMAN: That reads better.

DR. DYKES: So, how does it read?

MS. DILLEY: So, it says farmer demand for new benefits has become \--
farmer demand for new traits.

MS. SULTON: Are you just flipping the clauses around?

MS. DILLEY: Yeah.

MS. SULTON: Okay. So, go to the original.

DR. DYKES: Farmer demands for new traits has become a driver for
continued development of new agricultural traits because of benefits for
the production segment of the food and feed chain.

MR. OLSON: Yeah, something like that.

DR. MELLON: I have some small.

MS. DILLEY: Okay. Wait a minute. We haven\'t kept up with where you guys
are, so, let\'s make sure we\'re on the right language.

MR. OLSON: Michael said it best.

DR. DYKES: The right words are in there. We just switched it.

MS. DILLEY: I know. I just want to make sure we have them before you go
on because then we won\'t get other stuff.

DR. DYKES: Absolutely.

MS. DILLEY: But it\'s not farmer demand for new benefits. It\'s farmer
demand for new traits. Isn\'t that \-- I thought that\'s what you said.

UNIDENTIFIED MALE: Products.

UNIDENTIFIED MALE: Varieties.

MS. DILLEY: Demand for new traits.

DR. LAYTON: Okay.

MS. DILLEY: You\'ve got a driver for their continued development? Wait a
minute. Okay.

(Discussion off the record)

MS. DILLEY: All right. Now, where were you guys? What are we talking
about?

DR. LAYTON: You want to go back?

DR. CRAMER: Wait. We want to see there.

MS. DILLEY: Carol, I don\'t know if you were \--

MS. TUCKER FOREMAN: Yeah, I do.

MS. DILLEY: \-- next in the queue.

MS. TUCKER FOREMAN: Yeah. I think those would read better and be more
coherent if it said since 1995 when the first successful transgenic
crops were introduced in the United States, herbicide tolerant and
insect protected crops, and then I would drop the stuff about
effectively adopted and say, have generated substantial production
benefits, including improved soil conservation, so on and so forth.

It seems to me that that reference to having been rapidly adopted by
farmers in a number of regions of the world takes you off on a tangent
and disconnects from what you really want to talk about.

UNIDENTIFIED MALE: I agree.

MS. ZANNONI: I agree.

DR. LAYTON: Can you say that again, Carol?

MS. TUCKER FOREMAN: Okay. I\'m dropping all the words between after BT
crops, drop have been rapidly adopted all the way through \-- all
through the end of the chain and then say, herbicide tolerant, and drop
crops, and insect protected key crops have generated substantial
production benefits including, and then you just pick \-- substantial
benefits \--

DR. SCHECHTMAN: Production benefits you said.

MS. TUCKER FOREMAN: Production benefits, including. So you take out
benefits at the very end. And then just start the list of the benefits.
And I think that reads better.

MR. JAFFE: Take out the successful from that. Just say the first
commercial transgenic crops. Take out the l-y in commercially and
successful.

DR. SCHECHTMAN: I think that was there because FlavrSavr^®^ tomato was a
number of years before that.

MR. JAFFE: All right. But I mean, we\'re not here to say whether
Monsanto\'s books became successful, non-successful. I don\'t know if it
was in 1995 or some other time and, I mean, it just seems an unnecessary
qualifier.

MS. DILLEY: So, the first transgenic crop trades. So, just take out
since 1995. Why don\'t you just say when the first commercial transgenic
crop trades were introduced.

DR. SCHECHTMAN: Since the first \--

MS. DILLEY: When?

DR. LAYTON: Since the first.

MS. TUCKER FOREMAN: Since the first.

MS. DILLEY: Don\'t do that? Mardi?

MS. TUCKER FOREMAN: First of all \--

MR. JAFFE: The first transgenic traits \--

DR. DYKES: Were introduced in 1995.

DR. MELLON: A tiny one is that on line 699 we ought to get rid of that
comma after in those cases. BT corn in those cases where it decreased
insect damage. The second point is that I think in line 696 I suggest
that we substitute primarily for especially.

There\'s lower pesticide use really only in BT cotton. The evidence on
corn is very equivocal and, of course, herbicide tolerant increases the
use of pesticides. So, I think we want to focus \-- I think the accurate
word is that primarily in the case of BT cotton that\'s where you can
show decreases in pesticide use.

My third point is a more substantive one and I\'m going to ask Russ his
view too, but I\'m concerned that this \-- while I think it\'s accurate
that some farmers feel like this and their views, you know, are and
should be represented, I think it\'s also true that it isn\'t all
farmers. And I\'d like \-- I mean, a lot of the farmers I know, for
example, believe that you can get these benefits other ways.

And, so, I\'d like to propose amending the last sentence, line 700, to
just say while some farmers believe some of the benefits can be produced
in other ways, others are enthusiastic about the prospect of additional
production benefits from other new traits of biotechnology crops or
other new biotechnology crops.

But there\'s not universal agreement about the extent to which these are
really benefits. Some folks believe they are and, you know, it depends a
lot on who you are and how you farm.

DR. DYKES: I didn\'t capture Mardi by saying some farmers are.

DR. MELLON: Well, I want to be clear that some farmers aren\'t. There
are quite a few farmers who think you can deal with soil erosion other
ways; that you can reduce pesticides in other ways; that you can, you
know, become more flexible in other ways, so \--

DR. LAYTON: We have some farmers.

DR. MELLON: But that\'s why I want to \--

DR. LAYTON: Let them speak for maybe the farmers. How about that?

DR. MELLON: That would be good. I completely agree.

MR. GRANT: I didn\'t know it was up but I\'ll speak.

DR. LAYTON: Russ\'s is up and he\'ll speak.

MR. GRANT: I don\'t disagree that there are some farmers who are looking
for alternatives to transgenics as a way to develop their businesses. I
would be uncomfortable in characterizing them as some and some. I mean,
the statistics clearly show an overwhelming majority of producers are
enthusiastic about as this says. We could maybe use most and some or
something like that to accurately reflect what\'s happening in the
industry.

DR. LAYTON: But do we need to add it? That\'s the one question.

MR. GRANT: Definitely that you add something to represent the other
side.

MR. KREMER: I, for one, you know, I don\'t believe \-- up to this point
I think we\'ve been doing pretty impartial stuff, but I thought this was
from the beginning a very rah, rah type of thing that didn\'t present
the point of view of the farmers that have seen, for instance, you know,
adverse, you know, impacts of biotechnology with increased resistance
with, you know, a decrease in yield and things like that.

And I don\'t think that that fairly represents that point of view and
I\'d be satisfied if we put some words to that effect that, you know,
some farmers believe this or whatever. If not, you know, I would be in
favor of having a whole new issue talking about that that we don\'t want
to do.

So, that\'s my \-- the other thing is, you know, I don\'t necessarily
\-- I have also a problem with using the word farmer in the heading.
It\'s just something to consider because I think it is a farmer, you
know, in cases, but also the agricultural industry that drives demand.

I was out in St. Louis, for instance, with Monsanto here a few months
ago and talking about unveiling a new product that would enhance ethanol
production and it was the ethanol industry, you know, agri-industry, the
industrial industry that was driving that rather than, you know, there
were a few farmers there. So, I think that that misrepresents farmers in
a way.

So, somehow I think it\'s got to be worded to represent the other
viewpoint that some farmers believe in this but some farmers don\'t.

DR. LAYTON: Okay. But would you agree that most farmers, which you all
heard Duane say, most farmers are enthusiastic about this, but some
farmers aren\'t?

MR. KREMER: Some and some. Or many and many.

DR. LAYTON: Yes?

MR. CORZINE: Well, I think you\'ve got to say most because all you have
to do is look at the data. I mean, if it\'s there. And I also think if
you look at the products that are used in corn, besides cotton, and also
in soybeans, there\'s a definite reduction in pesticide use.

It has been \-- the market varies and it\'s been documented, the
herbicides. There\'s also been a reduction in fertilizers per bushel.
There have been increases in environmental quality and less soil erosion
and you go right on down the line of things that you cannot ignore.

We want to have balance here, but we also have to recognize we cannot
reduce the significance of the acceptance and the demand for new biotech
products by almost everyone, the majority, even the enhanced ethanol
that Russell talked about. It has been producers driving that because in
many areas it\'s the producers that own the ethanol plants.

DR. LAYTON: By producers you mean farmers?

MR. CORZINE: Yes. Farmer-owned plants, right. So, if you\'re going to
include something for balance you still need that most and some language
because it is as an organization we have had \-- if anything, the
troubles we\'ve had on the issue is trying to hold some things back
because producer demand is so high for these products and it\'s a
definite most.

DR. LAYTON: Okay. Let me suggest either most or many farmers are
enthusiastic, blah, blah, blah about the development of new traits. Some
farmers feel that traditional \-- can you tell me what the some farmers?

DR. MELLON: I said to leave similar benefits can be produced in other
ways. We could even include Russ\'s point that, you know, thinks that
there are downsides to biotechnology and believe that similar benefits
can be produced in other ways.

DR. LAYTON: Some farmers believe there are down sides to biotech \--

DR. SCHECHTMAN: To modern biotech.

DR. LAYTON: To modern biotech and that

benefits \--

DR. SCHECHTMAN: Similar.

DR. LAYTON: Similar benefits can be attained through other methods.

DR. MELLON: Yeah. Can be produced through other \-- in other ways or
through other methods.

DR. LAYTON: Okay. Is that a compromise?

MR. GRANT: That\'s a true statement, I\'m sure.

DR. LAYTON: Russ and I think I see Carol.

MR. KREMER: Yeah, and I appreciate that. I want to tell you that I
represent the second largest farm organization in this country and I
will admit that most of our farmers, most of our corn farmers have
accepted and have views. I mean, and that could be some terminology. I
don\'t like this word enthusiastic. I didn\'t like it from the very
beginning. I think that that \-- I think that sways us. Did we take that
out or not?

I could go along with most farmers have adopted or have accepted.

DR. LAYTON: I actually \--

MS. DILLEY: It\'s the last sentence.

DR. MELLON: So, you\'re proposing just the deletion of the word
enthusiastic?

MS. DILLEY: It\'s most farmers are looking something about the prospect.
We\'re trying to modify enthusiastic.

(Discussion off the record)

DR. LAYTON: Well, I think I compromised on either many or most and then
some because you say the numbers are much higher than just \-- it\'s
more than a majority.

MR. GRANT: Oh, yeah, and I think Russell\'s organization is the same
way, right, on the use of it?

MR. KREMER: Yeah. I said we have adopted it. Now, I guess the most
assumes that it\'s over half and I think that\'s a little dangerous.

MR. CORZINE: You don\'t think it\'s over half?

MR. KREMER: I can\'t say that. When you\'re generalizing here, Leon,
you\'re talking about \-- I\'m saying I think most of the corn farmers
or most of the soybean farmers, no doubt, no doubt in the world, most
soybean farmers in our organization, in the world, or, in this country
have adopted, but everything else, including wheat and whatnot, no. I
couldn\'t say that.

MR. CORZINE: If you look at the production acres, Russell, and you look
at and talk about the largest ag organization, whatever term, if you
just look at the acres used, the way they\'ve been adopted, you\'re
talking about soybeans, you\'re talking about corn, you talk about \--

MR. KREMER: Let\'s add that. I would go along with that if you would
specify those crops. This here is too general.

DR. SCHECHTMAN: He\'s talking about the other crops where the
innovations haven\'t come in yet like wheat.

MR. GRANT: So, how about most.

MS. DILLEY: Duane, do you have a suggestion?

MR. GRANT: The suggested language. Most farmers have benefitted from.

MS. DILLEY: Farmers who have benefitted from are enthusiastic about so
that helps qualify. Most farmers who have benefitted from are
enthusiastic about.

MR. JAFFE: Are grown though. I mean \--

MR. GRANT: Or grown.

MS. DILLEY: They\'re grown? Okay.

MR. CORZINE: They\'re growing them because they\'ve benefitted from
them.

DR. DYKES: Well, then would you say farmers who have grown biotech
crops? Would you say most of the farmers who have grown biotech crops
are enthusiastic?

MR. CORZINE: I think even some that are not are enthusiastic because
they\'re trying to get a niche market.

DR. LAYTON: It\'s transgenic, not biotech. Transgenic.

(Discussion off the record)

DR. LAYTON: Okay. We want to finish this one up fairly quickly. Okay. In
those cases is in red. Is it staying in or going out?

MS. SULTON: They wanted to take it out. Mardi wanted it out.

MS. DILLEY: No, she didn\'t. She wanted just the comma.

MS. SULTON: I thought she wanted the whole thing out.

MS. DILLEY: No, just the comma.

DR. MELLON: I put it in there because it is not the case at all that you
get the mycotoxin benefits from all corn all the time. At least in the
data that I\'ve read you get it in some cases some of the time. When you
get it, it\'s a real benefit and that\'s all I wanted to indicate there.

MS. DILLEY: Okay. So, are we there on that one? Michael, did you have
\--

DR. DYKES: I can\'t read it from here, but I\'ve listened to this
discussion. I just think this is similar to some consumers or most
consumers, the same things we\'ve discussed in the past. And are we
talking about all? No, we\'re not talking about all. And, so, we\'ve got
the some farmers, most farmers and I think what we\'re close to here,
and if it\'s what we really want to say, we should say some members of
the committee feel and other members feel because I don\'t want to keep
belaboring this on the some members and other members.

But I just think we\'re veiling this into that and let\'s just be honest
about it, that\'s what this is. Some members of the committee feel one
way and others feel another.

MS. TUCKER FOREMAN: Well, there are some data on this one and it may be
that the disagreement is about the extent to which these products have
been adopted and more farmers desire them. You know \--

DR. LAYTON: Let\'s read through it. Let\'s just read through it one more
time.

DR. MELLON: I don\'t think we need to do that yet. I really don\'t.

DR. LAYTON: Farmer demand has become driver for the continued
development of new agricultural traits derived from modern biotechnology
because benefits have been delivered to the production segment of the
food and feed chain.

Since the first commercial transgenic crop traits were introduced in the
United States herbicide tolerant crops and insect protected crops have
generated substantial production benefits, including improved soil
conservation through enhanced use of no-till or minimum tillage systems,
lower pesticide use primarily in the case of BT cotton, improved
flexibility and ease in pest management which has been documented in at
least one instance to result in greater net return to farmers, and
improved crop quality of BT corn in those cases where decreased insect
damage leads to decreased fungal damage and reduced levels of natural
mycotoxins.

Most farmers who have grown transgenic crops are enthusiastic about the
prospect of additional production benefits from other new traits and
some may choose to grow varieties containing new traits and this demand
is a driver for the development of the new traits.

DR. DYKES: I think if they\'re enthusiastic they will grow them, not
may.

DR. LAYTON: Okay. Some farmers believe that there are down sides to
modern biotechnology and that similar benefits can be obtained through
other methods. Go back up. I think you\'re right. And will grow \-- and
will choose to grow varieties containing new traits. I don\'t know about
the is a driver. The way you\'ve got is a driver is not right.

MS. ZANNONI: Just take it out.

DR. LAYTON: Take that out. New traits. End it, period, right below where
you are.

DR. SCHECHTMAN: No, next line.

DR. LAYTON: No, next line, new traits, period. Take out and this demand
is a driver for the development of new traits, period.

MR. GRANT: We can take it out but I just would make one more time the
case that producer demand will bring traits to agriculture that
otherwise wouldn\'t \--

DR. LAYTON: I disagree with you.

DR. DYKES: I think Duane thinks you should put a period after trait and
you start a new sentence. This demand will help drive development of new
traits.

DR. LAYTON: I think that\'s right. Undo it, undo what you just did.
Yeah, you\'ve got it. This demand will help drive new traits.

DR. DYKES: Drive the development of new traits.

DR. LAYTON: Will drive the development of new traits. Okay. Will help
drive the development of new traits. Then the some farmers is okay? We
can un-highlight that one and this one is done.

MR. CORZINE: I don\'t like primarily in front of the BT cotton, because
it\'s not primarily.

MR. JAFFE: Can you just delete that and say \--

DR. LAYTON: For example? Not put the BT cotton in there.

MR. JAFFE: \-- lower pesticide use and not put BT cotton or anything
else. Just say \--

MR. CORZINE: Just remove primarily in the case of BT cotton. Just remove
that phrase.

DR. LAYTON: Okay. Lower pesticide use. Improve flexibility in either
pest management. Okay. This one\'s going to bed. One, two, three. It\'s
3:30.

DR. SCHECHTMAN: Another insoluble problem solved.

DR. LAYTON: And that number was what?

MS. DILLEY: 20.

DR. LAYTON: Okay. We have 2, 3, 4, 5, 8, 9, 10, 11, 15, and 21.

MS. DILLEY: So, next up.

MS. TUCKER FOREMAN: I think we ought to take those that are most
contentious with the thought that some of the others we might be able to
address.

DR. LAYTON: Let me ask this. Who has to leave immediately or within the
next 20 minutes?

(Discussion off the record)

DR. LAYTON: Is there one of these issues that are something that \--
burning issues, burning to say something about that we should cover
before that?

MR. JAFFE: Isn\'t the meeting adjourning at four?

DR. SCHECHTMAN: I think we need to stop and see where we are.

MR. JAFFE: Yeah.

MS. DILLEY: We\'re not going to finish the document in half an hour.

DR. LAYTON: I thought that we were going late. I\'m sorry, I didn\'t
realize we were stopping at four. I apologize.

MS. DILLEY: So, why don\'t we talk about our options as to how we can
finish the document and then figure out a plan that makes sense to
finish the document. We have, I think, Pat, you\'ve got the tally up
there. We

have \--

MR. JAFFE: We have 11 to go.

MS. DILLEY: \-- 18 down, 11 to go. Okay. We have 18 and the vast
majority of really difficult ones are within that 18, so, we have 11
more to go. I would say half of them at least are more editorial in
nature than not, so, I mean, I think we\'ve made huge amounts of
progress. Nevertheless, we still have obviously work to do on them so
the question is, how do we most expeditiously finish the rest of the
document and we have not done the introductory section.

MR. JAFFE: Or title.

DR. SCHECHTMAN: I was just going to say that.

MS. DILLEY: The title, okay. So, those are our tasks to complete and the
question is, how best to do that. Michael and Mardi.

DR. DYKES: I think Mardi\'s was up before I was.

MS. DILLEY: Okay.

DR. MELLON: It just sounds to me like it\'s another meeting.

DR. DYKES: Mardi took the words out of my mouth. I think we need another
meeting to hash through these because I think to do them on conference
calls just doesn\'t work because everybody doesn\'t participate and then
we get here we have somebody who wasn\'t on the call has a viewpoint and
you may be happy with it, but if somebody else changes something then
you hear that, then you want to change that, so, I think it takes
another meeting.

MS. DILLEY: Greg?

MR. JAFFE: I was going to say I think this has been an amazingly
successful meeting. I think, you know, we\'ve accomplished huge amounts
in a very cooperative fashion. So, I told Michael if we had one more day
of this meeting I think we would get it done. I think we could do some
work in conference calls but I do think we need either one day out of a
two day, you know, plenary at some plenary discussion to get it done.

I think the one thing we haven\'t talked about here is, my count was at
least there were two members of the committee who weren\'t here today
and haven\'t talked about \-- I mean, I don\'t know how many \-- Carol
had comments. We haven\'t really addressed \-- whether we\'ve addressed
them or not, but we should talk also \-- I mean that\'s the problem with
the conference calls, not everybody\'s on it, but not everybody was here
also.

MS. DILLEY: We\'ve talked a little bit about that. I mean, I think one
is procedurally, I mean, it\'s our intention for one day. That means we
do not open up any of the ones that we\'ve finished in these two days. I
think for Daryl and Bob, the only one I can even imagine that they would
have any heartburn is that last one, the 28, because that was Bob\'s
issue. So, I think if you guys are willing to have the courtesy of at
least having him look at 28 only, or, the volume has to be extremely
high for those.

I think that\'s what we did for the previous two reports is the people
who were not here at all and we did such significant progress we set the
bar quite high and assumed that they\'re closed. But the only one I kind
of cringe on that is 28 because that was his particular topic. So,
Michael, I don\'t know.

And, but I think there\'s two steps of it. There\'s we close those among
the people who are here these two days and put those, the ones who are
not here, the bar is extremely high to make any comments and only ones
that would be subject to any kind of modification is 28 because 28\'s
Bob\'s issue.

Michael, you want to react to that?

DR. DYKES: Yeah, I would. I don\'t know that \-- I think we owe it to
the people who aren\'t here, and I think procedurally what we\'ve done
in the past, if you haven\'t been here you should at least have a chance
to enter and I don\'t think it should be limited to just one person\'s,
one issue that we know about, i.e., Bob on 28.

I mean \--

MS. DILLEY: Can we tell him the bar is high though?

DR. DYKES: I think what we should do is, you weren\'t here, but you
should go through these and if there\'s something that you\'re willing
to fall on your sword about you should raise it to the whole group at
the next plenary and we will try to put it in some members or other
members or we accept it or we discuss it.

MS. DILLEY: Fall on your sword is pretty high.

DR. DYKES: Kind of like what we did and I think we\'ll have to do it on
the overall document like we did last time. Once we get a final, final
text we have a one last conference call to say this has to be a may
instead of a could and I\'m willing to write a letter of rebuttal if you
don\'t do it. We\'re going to have to have that anyway so I\'d say we
give them that same kind of courtesy on anything they\'ve missed.

MS. DILLEY: Okay. Does anybody disagree with that?

DR. LAYTON: Carol\'s card is up.

MS. DILLEY: Carol.

MS. TUCKER FOREMAN: I wanted to address a specific issue. We haven\'t
been over 21 and that was one that I had a particular interest in and
sent around to you all and made the printed copies yesterday and it
included an effort to make some revisions in 21 that might make it a
little more \-- a little less controversial, but I have no idea if
that\'s, in fact, the case. So, that\'s just for the record.

DR. SCHECHTMAN: Carol, is that different than the comments you had sent
around previously?

MS. TUCKER FOREMAN: It is. I believe it is because what happened is I
didn\'t have 20, 21, and 22 that I commented on and I sent my comments
on December 20th or whenever it was and it had old versions of those
three and I was saying what\'s going on here, I know I was in a
conference call on these. So, later, immediately after I sent new
versions of those, but they came in two separate packages.

DR. SCHECHTMAN: But there\'s nothing new from that to the one you handed
out yesterday?

MS. TUCKER FOREMAN: Yes. In fact, on number 21 I had seen some of the
concerns about it so I tried to address some of those concerns and I
don\'t know that I did it so successfully, but I\'ve tried to respond to
some of the comments that you all made.

MS. DILLEY: We\'re going to have to do \-- I mean, so you\'re not
suggesting that we take up those issues now because we\'re not trying to
have a \--

MS. TUCKER FOREMAN: There was some text.

MS. DILLEY: Right. We\'re going to have to make a new document from
this, so, we just need to be sure that the compilation of the comments
on topics that we haven\'t done are the ones that are most updated. And
I think your comments are part of on the 21 and the other ones that we
haven\'t done we need to make sure we don\'t lose those for this next
meeting.

MS. TUCKER FOREMAN: Could we go through the ones that we have not yet
addressed and say which ones are obvious that most of us think will
require extensive discussion realizing our record on that hasn\'t been
particularly good? But there are two or three of those that really are
covered \-- you know \-- that have the paragraph below saying this is
covered in more detail in the labeling document. Maybe we could fix
those by telephone.

MS. DILLEY: Can we just get Randy, before we do that, maybe get Randy
and Greg\'s comments and then we\'ll \--

MR. OLSON: I thought I just heard someone say we have a one-day meeting
and I\'m just looking at 11 topics up there and the entire introduction
and suggesting a one day meeting is probably not going to work based on
our track record.

DR. DYKES: It needs to be two.

MS. ZANNONI: I think the introduction is going to take a day.

MR. JAFFE: I mean, I was going to say that I think there\'s some work
that can be done in advance of a one day meeting to get rid of some of
these things and make it a one day meeting. But we need to be very
careful about that. I mean, my assessment of the last round of
conference calls was in some ways it was helpful and in some ways it was
not particularly helpful.

There were some issues that were made easier and made things a little
smoother and there were other things that they just never tackled. And,
some of the same concerns that were raised in the last plenary were here
right away or they made some changes in the end because everybody
wasn\'t there and we weren\'t as a plenary, in my opinion, a very good
use of my time because we ended up rehashing or re-going over the same
thing.

I think there\'s some things like we don\'t have a title that at least
having a strong hand to come into the next meeting would be successful.
I think there are parts of the introduction, like that paragraph on what
is consensus and things like that, that we don\'t get work groups
together for some of those things and have a strong hand to come into
the meeting it will take a very long time to do those.

So, I think there are certain things that maybe there are some lower
hanging ones that we can just deal with.

MS. DILLEY: Right. So, in the absence of actually knowing that, perhaps
what we want to do is, I don\'t know. First of all, we need to know if
that\'s even an option with you guys. Second of all is, I think, the
better part of valor probably holding \-- looking for dates, knowing how
challenging that is, finding two days and then while we make progress or
a plan to make progress the way you suggested in terms of maybe we can
address some of these topics via conference call or whatever; that if we
find in the course of following that plan we don\'t need two days we can
only drop two days.

It\'s so much harder to decide you need an extra amount of time and not
be able to have it. I know you guys want to do two more meetings on
this, so, maybe the better part of valor is to secure two days when we
go out and look for dates and then we can always drop one of those
dates. But our basic question is, is that difficult in terms of
resources. I mean, obviously, we\'re trying to drive towards a one day,
but \--

DR. SLUTSKY: So, does this mean an extra meeting? I\'m a little confused
as to, you know, normally we resource for a certain number of meetings.
Are you talking about an extra meeting, an extra two day meeting than
you would normally have during the year?

DR. SCHECHTMAN: Yes. I mean, if we have the money for the precise number
of meetings that we currently go for. In other words, if the result
would be to try to go from four meetings a year we could not do that.
Our budgets are \-- it\'s a zero sum gain for committee budgets in the
department and it\'s already been fixed.

Whether we could \--

MR. JAFFE: That\'s independent of days. We\'re not like 8 committee days
and we do them in a different way.

DR. SCHECHTMAN: Yeah, I mean, if a meeting were to be done in five weeks
or the 10th and 11th of February if the members\' terms expire on the
following day.

DR. LAYTON: It would limit the number of meetings we have for the rest
of the year.

DR. SCHECHTMAN: It would limit the number of meetings for the rest of
the year.

DR. LAYTON: Between now and October we could only have two meetings.

MR. JAFFE: If we had a one day meeting we couldn\'t have another one day
meeting.

DR. LAYTON: One day meetings are expensive for all for those out of
town.

DR. SCHECHTMAN: They\'re just about as expensive as two-day meetings.

MR. CORZINE: There\'s more value in having that extra meeting for this
group.

MS. ZANNONI: Then you\'d only have two the rest of the year.

MS. DILLEY: For the new topics.

DR. SCHECHTMAN: It goes fiscal years in any case.

MS. DILLEY: So there are only two more if one of them is devoted to this
then the last one is devoted to the next topic. Right? Okay. So, that\'s
the deal.

MS. ZANNONI: What about announcing it in the Federal Register and all
that. Can that be done before the replacements, the new members come?

DR. SCHECHTMAN: Yeah, I mean, the only question that I don\'t have a
specific answer to is to what extent we can bend the rules to have a
meeting and bring you all in if you are not all \-- if some of your
terms have expired to get you back in for an official meeting?

MS. TUCKER FOREMAN: How many people do we know are leaving besides Ron?

DR. SCHECHTMAN: That\'s what we know, but then we have the whole
question of who is going to be reappointed.

MR. JAFFE: Like everybody else whose term has expired has been
nominated.

DR. SCHECHTMAN: So, it\'s Ron and Dick Crowder has departed but he\'s
departed before the end of the report. He\'s not a member of the
consensus.

MS. SULTON: Is it possible to have the meeting before the terms expire
or no? We\'d have enough time?

DR. SLUTSKY: Then you\'d only have one meeting from February to the
following October. You\'d only have one.

MS. SULTON: No, we\'d have two.

MS. DILLEY: Michael, your card.

DR. DYKES: Yeah. I was going to suggest that I do think we need to have
before we\'re deep into the next session I do think we need two days of
meetings. I\'d agree with that. I also think we need to organize around
like on some of the things, looking at things that are left, the title.

Maybe we can have a group that does a conference call that lays out some
straw models or something on titles and some of the unfinished products
so when we come back for the next meeting we got something to work from.

Then I think taking the 18 we\'ve done, putting those in the final text,
of circulating those to us, 11 we haven\'t done that has any and all \--
has all the comments added to it so we\'ve got something to review,
those kinds of \-- I\'d like to discuss that here, kind of what steps
can be taken so that the next time we have a two day meeting we can be
more productive.

DR. SCHECHTMAN: One observation, I think, from what you said about
conference calls not having resolved issues, that, you know, where
we\'re not down to the last word, I wonder if it would make sense to
send a draft for those issues that are largely the kind that I think
Greg alluded to about the ones that were done in the other report.

Maybe we could do all those by, I hate to use the word, chair\'s draft,
again, but having dealt with all of the largely editorial comments on
those, maybe we could send those around to everyone with the made
modifications that people wanted, thumbs up or thumbs down, or, at least
a pulse check to see if people are okay with this, do we need to hold a
conference call on those and then maybe we can put those to bed.

So, we\'ll only be left with a few.

MS. DILLEY: Carol and then Greg.

MS. TUCKER FOREMAN: I\'m trying to see. So far I\'ve found 2 and 10
where there\'s a reference to these being covered in the labeling and
traceability chapter. And had I missed others? Because it seems to me
that we ought to be able to do by telephone those that we\'ve already
covered in another report and that would reduce the number by \--

DR. LAYTON: You\'re correct.

MS. TUCKER FOREMAN: \-- two.

DR. SCHECHTMAN: Yeah.

MS. TUCKER FOREMAN: And if you add that on, you know, I\'ve done with
Michael and we\'ve done Michael\'s and we\'ve taken little bites that
might make the job a little easier.

MS. DILLEY: Greg?

MR. JAFFE: I mean, in the past, last time we finished a report where we
had some minor things that were done by committee members who were no
longer appointed. This time, we\'re running into this deadline of
February 12th. I mean, the ability to have a meeting between now and
February 12th is going to be fairly limited. It seems to me that there
has to be some \-- I mean, even if we were to have a meeting and do
this, but at some point you can\'t do conference calls, substantive
stuff, with people who aren\'t members of the committee either,
especially when new people have already been appointed.

DR. LAYTON: Let me suggest something. The majority of this committee is
located in Washington and I think the majority of this committee pays
their way when they come to a meeting because they\'re located in
Washington. Is that incorrect?

DR. SLUTSKY: No.

DR. SCHECHTMAN: No.

MS. TUCKER FOREMAN: Go ahead and finish your thought.

DR. LAYTON: Okay. My thought was that if those people were sitting in a
room and the rest of us called in by conference call that would
basically \--

MR. GIROUX: No.

MR. JAFFE: No.

MR. GIROUX: Because if you\'re on a conference call you\'re at a
significant disadvantage.

MR. JAFFE: And we did that. We\'ve done that. We did that in the past
with a work group where Carol and me and Michael Dykes came in a room.
Actually, we flew Duane in, but then some people from the conference
call didn\'t get on. I mean, we had a productive day but it didn\'t get
us anywhere.

DR. LAYTON: I\'m just trying to reduce the cost down to zero so we could
do as much as we could with all of us in place.

DR. SCHECHTMAN: If we\'re indeed having a plenary meeting there are sort
of legal requirements.

DR. LAYTON: We have to be here.

DR. SCHECHTMAN: And, well, no, you don\'t have to be here, but you need
to have notification under the public, etc.

MS. TUCKER FOREMAN: Let me try something. Are there questions, other
questions where we have a some members think one thing and some think
another and we have representatives of both groups in Washington where
we might sit down together and try to hash something out and send it out
to everybody else?

Once again, I\'m just trying to take bites where you can get bites
because I don\'t have any burning design for solving this whole problem.

DR. LAYTON: Abby, have we done all the some members think one?

MS. DILLEY: I don\'t know.

DR. SLUTSKY: Let me look because I have a list.

DR. SCHECHTMAN: We\'re close.

DR. SLUTSKY: We\'re very close. We just did 19?

MS. DILLEY: Oh, yeah. So, we would immediately need to secure dates,
late February, early March preferably for a two day meeting. So, when
does it have to be?

DR. SCHECHTMAN: The membership terms expire on February 13th. And I\'m
not sure that it\'s possible to pull off another meeting by February
13th. We\'re going to have to check and see.

DR. SLUTSKY: We have a lot of issues that we have to look at for the
committee in terms of the makeup of the committee because we\'re going
to \-- we\'re starting to head towards more specific topics where, you
know, we need the appropriate expertise for those topics, particularly
if we\'re going to do transgenic animals in the not so distant future.

So, we have to sit down with our General Counsel\'s office and look at
what our options are in terms of, you know, how the committee\'s made
up, what we can do with \-- you know \-- there are certain requirements.
You have a sub-committee and how you do that and, so, we have a lot of
issues with regard to, you know, how we have the appropriate make up for
the committee.

MS. DILLEY: Okay. So you guys need to determine committee configuration
out and then sets the parameters by when we \-- what timing the timing
is for a meeting to complete the document.

MS. TUCKER FOREMAN: We did a couple of summers ago have these work
groups that didn\'t have everybody in on them and somehow we did that
within the constraints of the advisory committee.

DR. SCHECHTMAN: Yeah, but work groups don\'t make decisions.

MS. TUCKER FOREMAN: Well, this one didn\'t make decisions either, but
only tried to iron out obvious differences within the whole committee to
take a look at, therefore, reducing \-- I\'ll tell you what I was trying
to. I was trying to look to where we could be, a one day meeting, one
day of the first meeting of the new committee when we could finish this.
But unless we can find ways to chop off some of the chunks there\'s no
\--

DR. LAYTON: Well, we won\'t if we can\'t do it before February 13th
unless they could get an extension, special acceptance. We wouldn\'t
have our committee here to do it. And it would be very difficult with
all the new members.

MS. TUCKER FOREMAN: I would just say that I know that we have a problem
of losing several old members perhaps, but I can only say when a couple
of the documents were very close to being in their final form and I
said, you know, and I think we may have to ask that kind of forbearance
of committee members.

DR. SLUTSKY: If I could just say something. I mean, I think Carol raises
a very valid point. I mean, that\'s the nature of these kinds of
committees that people come on and come off, you know, routinely and,
you know, how the committee works has to take that into consideration.
One thing I was going to suggest, and, again, it\'s along your lines is,
at the very least I would hope that we would have at least a half day at
the next meeting where we could start teeing up the new topics, and
particularly if we have some new members coming on board.

And, so, if we can do some preparatory work so that we, you know, can
finish this up in a day and a half and spend the last half of the half
day, you know, starting to, you know, discuss the new topics and how we
want to organize ourselves for the new topics then that might be, you
know, the way to go.

MS. TUCKER FOREMAN: That would work and we could find a way to do the
\--

DR. SCHECHTMAN: Yeah, and my additional desire would be that even if we
do this after the turnover and have brought in some new members we find
a way to bring in those few members who might be rotating off the
committee to drag you back here even if you\'ve already said you\'re not
coming back for that day or day and a half.

MS. TUCKER FOREMAN: I think that\'s very important that it can be done.

MR. JAFFE: I mean, the FDA committees, they make people special
employees for a day because they bring in special people at the FDA
advisory committees just for that one. They have a standing committee
but then depending on what the topic is they bring in different people
just for that specific topic and they make them a special government
employee just for those two days and for that information.

So, if there\'s any way you can make the people who are leaving
reappointed special employees for the purpose of the committee for the
next meeting. I guess one thing I would say is, I mean, I think having a
meeting separately before those dates will be almost virtually
impossible. I don\'t think that would be a good use of us. I think a two
day meeting, one day on this and one day on the new topic would be much
better.

The question \-- but I also don\'t want to wait till April or May for
this meeting. We have a limited period to finish this. So, I mean, I
guess the question is, to the department is, if we have a meeting in
March, will the new people be appointed and be ready to come in to a new
meeting? Because, I mean, it seems like I don\'t think we can do it
before February before they leave.

You guys are not going to have your appointments done so we can have a
meeting at the end of February, but March would be the ideal time to
have a meeting assuming the department has the people appointed and the
committee is up and running to have that meeting.

That seems to me the limiting factor for the next meeting is when is the
decision going to be made and I\'m not asking you for an answer. I\'m
just saying that should be a big basis for the timing.

MS. DILLEY: So we\'re trying to get a two day meeting figured out
sometime in March/April, ideally one day of it is to complete the
document, but I think the missing piece is knowing whether we need the
one day or the two day and the question is, how can we make progress on
portions of the report and I think it\'s hard to know that in the next
few minutes figuring that out.

I mean, I guess, what we need to do is put together the document as
suggested in terms of changes that have been made on the 18, the 11 that
don\'t have changes, make sure we\'ve compiled all the comments.

I mean, it\'s hard for us to assess, at least for me to assess without
not everyone having commented if I\'m guessing on the right amount of
allocation of work on differences of opinion without getting some
feedback from all the committee because of what I think are just
editorial comments may not be.

So, it\'s hard to come up with that plan. I think maybe what we need to
do is get that document turned around and come up with a proposal as to
how to proceed and making some progress while we\'re seeking dates for a
March meeting, a two day March meeting that will probably have some time
to go to finish this document and some time for new topics and then
evolve a plan that gets enough progress that it takes a day instead of
two days.

I don\'t know what else we can do right now in terms of getting more
particulars.

MS. TUCKER FOREMAN: I agree. But you know, I don\'t know what to say
about persuading people to take a look at what you send out, they send
you comments.

MS. DILLEY: So we can throw out a proposal and options of how to do it,
whether it\'s by conference call, a group meeting that can help tackle
some of this stuff, and make progress on it before that one day meeting
while we do make decisions, but it\'s hard to know that right now
without having a chance to really sit down and see what do we have left.

DR. LAYTON: Let me ask a question on that. Carol, the document you
mailed out Thursday, or Wednesday, that has all your changes. There are
no more?

MS. TUCKER FOREMAN: That\'s right.

DR. LAYTON: Greg, I have effectively all your changes based on what you
sent out on Wednesday. Yes?

MR. JAFFE: The document I sent both \-- the document I sent December
22nd.

DR. LAYTON: And reiterated on Wednesday.

MR. JAFFE: Right.

DR. LAYTON: Okay. One of the problems I have, and it\'s not Carol\'s
document, it\'s your document, there\'s a lot of "I thinks" but I don\'t
know what the changes are. It\'s really hard to tell some in those cases
where you\'re changing or where it\'s explanatory.

If you and I can work to make sure I\'ve got specific things on that and
that I\'ve got them in there correctly, if you and I can do that,
Carol\'s, I think I can pick up and I\'m going to ask one of my
assistants \--

MS. TUCKER FOREMAN: You know what I can do is I can take mine back and
give you two different colors.

DR. LAYTON: I think I\'m going to have my assistant fix it.

MS. TUCKER FOREMAN: Okay.

DR. LAYTON: She\'s better at these things than I am.

MR. JAFFE: My suggestion would be, I think at this point, since we\'re
down to a few issues is if we could not do the side-by-side but just
have a red lined strikeout.

DR. LAYTON: I can\'t incorporate everybody\'s into a red line strikeout.

MR. JAFFE: From the ones that are left I don\'t think there are so many
that I think those could be, but maybe I\'m wrong. You can put comments.

DR. SCHECHTMAN: We\'ll look and see, see how we can do it.

MS. TUCKER FOREMAN: By the way, this doesn\'t require me to be an expert
in MicroSoft.

DR. SCHECHTMAN: Can I ask one specific question? There was one point and
I know I walked out of the room briefly a couple of times. But there was
a place where you, and I forget who else, were working on a draft with a
new sentence.

DR. LAYTON: Right.

DR. SCHECHTMAN: Was that done?

MS. TUCKER FOREMAN: No.

DR. LAYTON: Can we do it before we leave?

MS. TUCKER FOREMAN: Yeah. We can take care of that sentence before we
leave.

MS. DILLEY: We need to figure out a way to have people\'s comments as
well as \-- do you guys want something like the colorful document in
terms of that language that takes an attempt to integrating that stuff
or you don\'t? You just want to see the rough comments compared to the
text?

DR. LAYTON: Because I could take the colorful comments and put them in,
make black and find all the ones that we\'ve done and complete it.

DR. SLUTSKY: We have that.

DR. LAYTON: I know that, but I\'m putting them all in one document.

DR. SLUTSKY: They\'re already in one document.

DR. LAYTON: And then have the colorful document to work from for the
rest of them. Okay.

MS. DILLEY: Okay. So, if we can do that and people want to \-- if you
need on some topics \-- some topics may need a more elaboration on
people\'s comments. We\'ll try and compile those in some way. I\'m not
sure how we\'re going to do it now. We\'ll figure it out.

MS. TUCKER FOREMAN: Can I ask the question, is the colorful document as
a base and take out everything we\'ve already covered and have in it
just those issues that we haven\'t covered.

MS. DILLEY: The 11, right.

MS. TUCKER FOREMAN: And then put that out as a side-by-side so that we
can see \--

DR. LAYTON: Comments on it? Okay.

MS. DILLEY: That would be a way to do it.

DR. LAYTON: Is that okay with you? I mean, I\'m happy to do that.

DR. SCHECHTMAN: Greg requested non side-by-side.

MS. SULTON: We have a document that has all the changes. It\'s not in
the colorful document.

DR. LAYTON: No, no, no.

MS. SULTON: I can replace \-- the stuff we haven\'t addressed to date is
in the colorful document, is that right?

DR. LAYTON: That\'s correct.

DR. SCHECHTMAN: Let us take this back and see what we\'ve got.

MS. TUCKER FOREMAN: But something that \--

MS. DILLEY: Takes a run at it.

MS. TUCKER FOREMAN: Use the colorful document as the base. There will
still be comments on it. So, you\'d have to find a way to accommodate
the comments based on our discussions today. I think that we might have
fewer. On the other hand, maybe it reduces everybody\'s.

DR. MELLON: I mean, ideally you need both. You need the colorful
coherent kind of integrated sentences based on comments and then for
the, you know, ideally you would like to have the substance of those
comments organized as the side-by-side does so that people can look and
see whether there were hundreds of things on one question or only one or
two.

DR. LAYTON: The majority of them because everybody\'s got Carol\'s and
everybody\'s got Greg\'s now.

DR. DYKES: I would just say I\'m where Mardi is. I think if your
colorful document really truly had everyone\'s comments incorporated
because that\'s helpful. Where it falls apart is you don\'t have Greg\'s
or you don\'t have Carol\'s last one and then we\'re going to \-- so I
think now that you have Greg\'s and have Carol\'s we could have one
document that says here\'s an attempt to put it in there because when we
get down to push comes to shove we intend to rely on pulling a phrase or
sentence from someplace else and inserting it, so, it takes a lot less
time.

DR. LAYTON: Okay. We can work on that.

MS. TUCKER FOREMAN: Because most of my edits deal with the early numbers
until you get up to, I think, 8. My comments were virtually all
editorial.

MS. DILLEY: Yeah. Okay. So, we can put something like that. I just think
that\'ll help us assess how much more work we need to do and it depends
on everybody commenting because it\'s not just Carol and Greg. I mean,
we obviously had people brought, even though they didn\'t submit
comments, they had a lot of comments on the document.

So, we really need feedback from all committee members because that
helps us assess how much we need to do and how best to do it.

DR. CRAMER: You\'re saying that people look at this now and have
additional comments?

MS. DILLEY: No.

DR. LAYTON: Not on the ones we did.

DR. CRAMER: No, not on the ones that have been done, but the ones that
haven\'t been done, you\'re open for that?

DR. LAYTON: No, that\'s not what I said. I said, anything that we\'ve
got. There are some that I missed on Carol\'s and I want to make sure
Greg\'s are visible.

DR. CRAMER: That\'s what I thought you really meant.

DR. SCHECHTMAN: And that captures it. It doesn\'t preclude people when
we have a meeting from making comments.

MS. TUCKER FOREMAN: Absolutely.

DR. CRAMER: But that\'s an open invitation for a whole new set of
comments.

DR. LAYTON: No.

MS. DILLEY: It would be nice to know whether \-- I mean, people have not
commented. I don\'t know if people want to comment and are okay with
that language so it\'s hard to assess how much work needs to be done to
accommodate everybody\'s concerns. So, that\'s all I\'m saying. It\'s
still an open document on those 11. While we\'re not inviting a whole
new rash of comments we also need your feedback.

MS. TUCKER FOREMAN: I do think that the colorful document speeded our
work over the last two days.

DR. SCHECHTMAN: And thank Abby again.

MS. DILLEY: Okay. So, we\'ll come up with a plan and then we need
feedback from you and it\'s kind of a back and forth process to figure
it out.

DR. LAYTON: Greg, you had a comment?

MR. JAFFE: No. I just was going to say that, I mean, only have people
send comments into you. If those people have comments they should send
them in. It\'s better to see them than to not see them and wait for a
plenary to happen. So, it\'s an open invitation, but people have
comments, get them in.

MS. TUCKER FOREMAN: I don\'t know any other way to get people to deal
with it who haven\'t already.

DR. SCHECHTMAN: Okay.

DR. LAYTON: Actually they should get comments by the 13th just so
they\'re still official members of the committee.

DR. SCHECHTMAN: We\'ve got a way of making it just a smidgeon longer. We
have to figure out how to do it. So, I think we need to wrap this up. I
want to thank all of you.

(Whereupon, at 4:09 p.m., the meeting was concluded.)