UNITED STATES DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C.

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:

ADVISORY COMMITTEE ON :

BIOTECHNOLOGY AND 21ST CENTURY :

AGRICULTURE (AC21) :

TWELFTH PLENARY MEETING :

:

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A meeting in the above-entitled matter was held on Wednesday, March 29,
2006, commencing at 8:38 a.m., at USDA, 1800 M Street, N.W., Waugh
Auditorium (3rd Floor), Washington, D.C. 20036.

Patricia Layton, Chairperson

APPEARANCES

JOHN RADIN

ALAN MCHUGHEN

ABBY DILLEY

KATHY GRANT

CINDY SULTON

LEON CORZINE

NICHOLAS KALAITZANDONAKES

VINCENT VILKER

DUANE GRANT

MARGARET MELLON

JOSEPHINE HUNT

ALISON VANEENENNAAM

STEVEN PUEPPKE

ADRIAN POLANSKY

RONALD OLSON

GREGORY JAFFE

JEROME SLOCUM

DARYL BUSS

BRADLEY SHURDUT

CAROL TUCKER FOREMAN

ROBERT HERDT

CAROLE CRAMER

MICHAEL DYKES

RUSSELL KREMER

LISA ZANNONI

PATRICIA LAYTON

RANDAL GIROUX

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

MS. SULTON: We\'re going to start this morning with Abby going over a
little bit of the work plan so we know how we\'re going to get the final
report to you and get your final acquisition approval on it, and after
we do that then we will have our second set of speakers and some
discussion about their presentations, as well as about the tasks before
us over the next year.

And in that discussion we will be asking, \-- in both discussions we\'ll
be asking you to take a look at your calendars. We\'ll probably need a
conference call some time in May and we\'ll talk to you about those
dates, and then we\'ll also be looking for our next meeting. So, if we
could start then with our first set of speakers. Oh, we\'re going to
start with Abby going over the work plan for getting a final report to
you.

(Off the record discussion.)

MS. DILLEY: Today is March 29th and we have a provisional final
document. And that provisional final with all the changes incorporated
will go out to all members no later than Friday, April 21st. We have
some things that we need to do first. We\'re working with that schedule,
plus we have a few details to take, to deal with before. We\'ve got
cites we need to collect and we have bullets to be arranged, *et
cetera*, just to get it all in place and make sure that it\'s as much
completed as possible.

So then you\'ll have two weeks to look over the document. It\'s a very
similar process to go on and use with the other two reports. You have
two weeks to, so by Friday, May 5th, all comments are in. What we\'re
looking for, yeah, and they\'re only comments, questions of fact. This
is very hard language to change, basically. It\'s only questions of fact
and any clarity issues. And I\'m trying to think of an example, and you
had one.

MR. SCHECHTMAN: That was, the one example that we had had that came
already was the sort of thing where \--

UNIDENTIFIED FEMALE: U.S. can\'t trade. Produce and trade.

MR. SCHECHTMAN: No. That was a question of fact.

In terms of clarity there was the issue of whether or not a statement at
the end of one of these things in a something this, or something that,
refers to one group, two groups or three groups, if that needs to be
clarified, for example. Both of those kinds of things are things of the
sort that you would expect to be non-controversial.

MS. DILLEY: So depending on the number and types of the comments that we
get in by May 5th, we\'ll either schedule a conference call to talk
through those, I think we did the last time with one of the reports as
well, or we won\'t have a call. It\'s just pretty straightforward and
there are, you know, making U.S. into U.S. producers. It\'s very
straightforward. So if we need a call we\'ll schedule one no later than
between the 5th and the 19th. If we don\'t need a call, then we\'ll just
finalize the document, send it out to everybody and give you a week to
10 days to have one last look and it\'s a thumbs up, thumbs down.

And at that point, I think we also asked in the last report that if it
is, \-- if there are any abstaining from the report or not, if you\'re
going to submit a, you know, why, and are you going to submit a minority
report. I don\'t get the sense that we have that right here, but, you
know, we\'re giving that time to thumbs up, thumbs down and some
explanation as to whether or not we have full consensus.

And so hopefully, that would mean then that we would have a final
document either at the very end of May. Depending on whether we need the
call or not, it will either be before May, and then the submission to
the Secretary. In the meantime, we can also start drafting a cover note.
We did that electronically, and there was no problem in doing that,
getting comments back electronically for the cover note and Pat\'s going
to read it for submission to the Secretary. Then the document will be
finalized with a letter and submitted to the Secretary.

So that would be no later than late May, early June, depending on
whether or not we need that call. Any questions?

MR. SCHECHTMAN: Let me just add one thing. I know that on the last
documents there was a desire to have the document, a ceremony of sorts
where the document was provided to the Secretary. I guess a question
that I would ask is, is that something that the committee wishes to do
again? Okay. I guess the one, I think I saw a couple of nods, some that
may have been just trembling from the morning coffee.

I guess we\'ll work out the logistics. I\'ll have to be in the
Secretary\'s office to figure out how and when that will be done. The
one bit of logistics that I will mention is that our committee has been
increasing in size, but not increasing in budget. So flying in a lot of
people will be a bit more challenging.

So I\'m going to ask when we get to that point to see to what extent we
can have a relatively small, representative group come and give the
presentation. Though you all may be delighted to be there and say, yes
we finished this three year project. But we\'ll work out all of that via
emails and see who wants to be involved in that process.

MS. DILLEY: So any questions or comments on the process or dates? Okay.
We\'ll draft a follow up memo after the meeting to have that in front of
you so you have a copy of it. Okay. All right. Good.

MR. SCHECHTMAN: Okay. Well I see our, the one speaker I was worried
about the arrival of has made it here. So now we come to the final topic
for this very productive meeting, and that\'s the new topic that reads
on your handout, What avenues of technology transfer or actions by USDA
are most likely to result in the production of biotechnology derived
crops other than large-scale commingled major commodity uses that would
have the greatest positive impact on domestic markets, rural communities
in the United States, and developing nations?

This is a topic on which we are specifically looking for
recommendations, a first for this committee. There are probably a range
of different types of actions that USDA could conceivably consider in
this regard, and I\'ll just give you, just an off the top of the top of
my head list of sorts of things. It could be supporting particular types
of underserved research areas that are of public benefit. It could be
actively supporting risk assessment research on particular identified
crops of public benefit.

It could be adopting some sort of measuring tool to assess public
benefits. It could be targeting license initiatives to get particular
crops into the private sector. It could be some particular specified
activities at the farm or community level. It could be partnering on the
international side with developing country scientists on certain
projects. It could be encouraging seed sector development in particular
countries. It could be, I don\'t know what else could be on your radar
screen. Those are not meant as any particular ideas that you should
include. Again, that\'s just a laundry list of possibilities off the top
of my head and not intended as a guide for your discussions.

There are some kinds of activities that are already underway in USDA and
you will hear about some of that today. So the topic is very broad in
terms of suggestions that you might give. Let me give you a few thoughts
about sorting this out. We\'re not looking for a huge laundry list of
recommendations. If you came up with five, maybe with a brief
explanation of each that you think would be appropriate and useful, that
would be great.

And I\'m guessing that probably with each of them there might be a
caveat or two attached. We\'ve also given you in this topic three
different benefit targets, markets, rural communities, and developing
nations. We don\'t need to put these targets in opposition to each other
and I also should stress that we\'re talking about public benefits.

So even though the word consumers was not there in the piece that was
handed out to you, we\'re talking about not necessarily, there are all
sorts of ways public benefits, so there may not be direct benefits to
consumers, but consumers are never far behind in this discussion. The
extent to which you want consumers to be explicitly in there, you\'ll
all have to discuss, but they\'re obviously never far from the topic.

We\'re asking you about benefits. We don\'t want you to put any of these
different targets in opposition with each other. We\'re asking about
benefits for the public, benefits in at least the general sense. So, you
know, that can be improving marketing opportunities for a particular
crop of importance that\'s public, to a group of farmers addressing
significant disease issues that might limit cultivation of a particular
crop, expanding rural opportunities with new products that might meet
the downstream value-added opportunities perhaps.

Maybe help better to address development of particular crops where
they\'re appropriate to meet the needs of farmers. It\'s a broad
possible range of things that you might decide in your priority setting
that you want to go at. We\'re not asking you to provide the strategies
in situations where the benefits might accrue to U.S. competitors. Not
that I think you\'d do that anyway. We don\'t anticipate that you\'ll
suggest how we\'re going to bring new biotechnology products to
competing farmers in major South American producing nations.

We\'d like you to consider this in the context of delivering public
benefits. Not the private benefits. We\'re not looking to necessarily
accrue to particular players in the end, but the private benefits
themselves are not the focus. And even though the recommendations won\'t
be targeted to achieve benefits in all three of the areas, we\'re not
interested in recommendations that put any of these targets in conflict
with each other or put us in competition with the poorest development
countries.

How do you rank the importance of each of the three goals, and in fact,
whether you decide whether you can address all of those three targets is
going to be up to you. But I would expect that you\'re going to wind up
doing a good bit of brainstorming on the topic around what existing
limitations are, identification of a lot of possibilities, and some sort
of ranking process to get to some recommendations.

Now what we have for you today are two presentations to provide you some
background for your discussion, and there could very well be some
additional presentations at the upcoming meeting as well, after this
one. Our first speaker \--

MS. FOREMAN: Michael?

MR. SCHECHTMAN: Yes?

MS. FOREMAN: I\'d really like to say something before we hear the
speaker, because I\'d like the context to, in which he speaks to
consider that. May I do that, please?

MR. SCHECHTMAN: Go ahead.

MS. FOREMAN: Thank you. I\'ve tried to rewrite the bullet in part
because I hard time trying to figure it out, and in part because it
really troubles me when I read something that says that the United
States Department of Agriculture wants us to think of positive impacts
on domestic markets, rural communities and developing nations, and
doesn\'t say anything at all about things that might benefit the
American people for whom, I assume, the Department of Agriculture works,
not just the two percent who raise food and fiber.

So I\'ve tried a rewrite that I don\'t think does damage to what you\'re
looking for, but would make me a lot more comfortable. There\'s a second
issue, I think the way the original one\'s written, it really excludes
any notion that technology transfer might or biotechnology might not be
the best way to achieve some of these goals, but that technology
transfer, new kinds of, other new kinds of breeding or even conventional
agriculture may be the best way. And I think that it\'s, \-- we don\'t
have to recognize that, but the current emphasis makes me uncomfortable.

So let me try this. What technology transfer activities could USDA
undertake that would be most likely to contribute the safest and most
nutritious food supply for the American people, encourage growth in
domestic markets, \-- and I have parenthesis for what, because I\'m not
quite sure what that means, benefit rural communities and contribute to
improve food security to developing nations? Which of these goals might
best be advanced through the use of agricultural biotechnology and which
through other forms of breeding? Can the technologies be applied other
than to large scale commingled major commodities?

MS. DILLEY: On that, I think we\'ve got a lot of work to do on both
bullets. I mean, I don\'t think, I personally, and I think for the
facilitators, we couldn\'t develop a work plan based on the way they\'re
framed right now. I think we need a lot of committee discussion to
really hone in on what is the committee trying to address within the
context of these two bullets that have been given to it as our charge,
and we\'re going to need a lot of massaging until we end with a
statement that we all understand, and build a work plan around.

So if we can maybe take the language if you can type it up. We\'re going
to be doing a lot of flipchart work and a lot of work post of
presentation to really fine tune both charges in order to develop a work
plan and get ourselves going. So if are thoughts are on the table, I\'m
sure there are probably others that other people have and that\'s good.
We need to do that, because you can\'t walk out of here without some
sense of being on the same page or what we\'re doing and how we\'re
going to do it. Is that reasonable?

MR. FOREMAN: Yes, thank you. I appreciate the opportunity to make the
point.

MR. SCHECHTMAN: So our first speaker for this morning will be Dr. John
Radin who is National Program Leader for Crop Production and Connection
at USDA\'s Agricultural Research Service, and he will speak to us today
on research efforts by the USDA Agricultural Research Service in
Specialty Crops. Welcome, John. Thank you.

MR. RADIN: Thank you. Distinguished members of the committee and ladies
and gentleman, can you hear me? I know you can\'t all see me. First of
all let me say that this talk is about research on genetically
engineered specialty crops in the Agricultural Research Service, which
is the in-house research arm of the Department, and it does not cover
activities that are rendered by our sister agency, you know, CSREES or
the Cooperative State Research Education and Extension Service,
representatives of whom are here in the audience.

And so we are talking specifically about the in-house research program,
and if you have questions later about the National Research Initiative
or funds that go to the Land Grant colleges and universities, you can
direct them to some of the other members of the audience. But between
CSREES and ARS, I think we pretty much cover the waterfront in terms of
research funded by the U.S. Department of Agriculture.

This is about genetically engineered specialty crops. And the definition
that\'s used in the Specialty Crops Competitiveness Act of 2004 is that
it includes fruits, vegetables, tree nuts, dried fruits and nursery
crops, including floriculture. In other words, not the major commodity
crops. And this, of course, is a very diverse panoply of agricultural
products, some of which are displayed on the screen here. Of course the
traditional fruits and vegetables, but also floral crops, in which we do
a lot of work such as the bird of paradise on your left, or the
poinsettias on the right.

Specialty crops in U.S. agriculture create about half the value of crop
products in the United States. Even though each one of them is much
smaller than say the major commodity crops like soybeans or corn, but
they are very high value crops. Of course we all understand that
they\'re necessary to provide healthful and nutritious foods for a
balanced diet, and so they are certainly an important component of U.S.
Agriculture, and not least, they diversify income sources for farmers
and they enhance the rural economy.

And so they deserve some very special consideration about why, what we
can do to enhance their production and increase their availability. I
was speaking about genetic engineering, how have specialty crops faired
compared to other crops in the United States, and these numbers are
approximate, but if you look at the big three, cotton, soybeans and
corn, which we all know have extensive penetration, in genetic
engineering, into the seeds, the marketplace. Cotton and soybean are
essentially saturated in terms of the percentage of the crop that\'s
genetically engineer. Corn is not, but it\'s increasing slowly still and
there\'s major penetration.

Canola, an oilseed, is probably about 70 percent genetically engineered.
This is largely grown in Canada, not so much in the United States, but
in the Northern Tier states in the Great Plains it is a major crop, and
is largely genetically engineered for herbicide tolerance. The only
minor crop that\'s on this list, the specialty crop is papaya, which
there\'s been a story that\'s been very well publicized and you probably
all know about that. In Hawaii there is a genetically engineered papaya
which is resistant to the papaya ringspot virus disease, and it has
essentially saved the Hawaiian papaya industry. And so there\'s major
market penetration there of that genetically engineered papaya.

As far as other crops go, of those that have been deregulated, at least
by USDA, that's the Animal and Plant Health Inspection Service, there is
either none or next to no market penetration by these deregulated
genetically engineered crops. And these include a lot of the high value
specialty crops, tomatoes, potatoes, squash, *et cetera*, and so
obviously, some of the major crops and some of the specialty crops have
faired differently with regard to the use of genetic engineering.

What is ARS doing with specialty crops? If you look at all of our
research together, not just genetically engineered specialty crops, but
everything, you can see that we\'re spending about \$190 million per
year on research spread across many of our approximately 100 labs around
the country. And of that total, a survey of all of the projects shows
that \$4 million of that or about 2 percent is actually spent on genetic
engineering research to produce GE products.

Compare this to the major crops that we work on where we spend \$390
plus million and the percentage there devoted to genetic engineering is
still small, but is in percentage terms is twice as high as it is for
specialty crops.

Why is that? Why are both of these numbers so small and why is one
smaller than the other? Well there are some specific reasons. They limit
our putting funds into genetic engineering research in specialty crops.
First of all, in looking at the major crops, we are not in competition
with the private sector to develop genetically engineered products, and
where there are market opportunities, the private sector has moved into
those and has delivered products, and it is not our business to try to
compete with them. And so in many cases we simply do not take these on
because we are spending public dollars and there are other research
goals that need to be fulfilled.

And also, it\'s worth noting that genetic engineering is not an easy
process. It\'s slow and it\'s difficult, and there are some technical
obstacles. And so to do it well requires a considerable investment. If
there is a natural genetic variability for traits that are needed, it\'s
often cheaper to go the conventional breeding route. And so when there
is a choice like that we in ARS will preferentially use conventional
breeding in order to create the new traits.

With specialty crops the situation is a little different. Often there is
no commercial outlet for the public because of, first of all, you know,
there has been, obviously, as we all understand, some resistance to
commercialization of these products and if there is no way to
commercialize the product that we develop with our public funds,
there\'s really no point in engaging in the research in the first place.

And so this has certainly been an impediment to ARS investing in genetic
engineering in specialty crops. Again, it is slow and difficult and
probably requires a greater investment than conventional breeding, if
conventional breeding is suitable. It\'s also worth noting with
specialty crops such as tree fruits or small fruits, many of them are
only a generation or two removed from the wild, and so there\'s a
tremendous amount of genetic variability yet which is not even fully
characterized, much less tapped in order to create traits of what are
needed. And so in the case of specialty crops, there are many more
opportunities to try to use conventional plant breeding to create the
traits that are needed.

And so these reasons all underlie why we have only two percent of our
research funds in specialty crops actually devoted to genetic
engineering of important traits.

When do we actually decide that it\'s appropriate to pursue a
genetically engineered product? Well, generally we go through a
case-by-case analysis and evaluate each one on its own merits, and there
are a number of criteria that we use to make those decisions. First of
all, will the project serve a public purpose? I notice that Ms. Tucker
Foreman mentioned this earlier, we certainly are concerned whether there
is a public purpose that is a higher priority than other types of
investments, so for example, if a private company wants to develop a
particular trait which will serve them well, there is really no need for
USDA to get involved in that kind of research.

And so we ask that question first of all. Secondly, if we do pursue this
pathway, are there obvious environmental or biosafety concerns? We know
that, of course, these products are regulated and they have to be proved
safe before they can be released, and so first of all it\'s, if we\'re
going to pursue this kind of product we have to make sure first of all
that we can overcome any biosafety issues, and secondly, we have to make
sure that we have the resources somewhere to be able to collect the risk
assessment data that are necessary to have it deregulated. And both of
those are very significant.

Generally, when we work on genetically engineered products of major
crops, we will end up turning the product over to a private sector
partner who will invest the money in the risk assessment data
collection. In the case of specialty crops, that\'s much harder because
they\'re grown on smaller acreage and it\'s more harder to get a
commercial, for-profit company interested in these matters. And so often
we in ARS will develop the biosafety data ourselves which requires a
further investment.

Will this duplicate or parallel private sector efforts? Certainly if
there\'s something going on in the private sector, there\'s no need for
the public sector to do the same thing, and to try to develop competing
products. And again, I can\'t emphasize this one enough, will
conventional breeding suffice? It is the preferred route if there is
genetic variability for us to tap into and try to use to develop an
improved product.

And then these projects using conventional breeding by far predominate
over the ones using genetic engineering. And then lastly, is a
reiteration of points made earlier. If the research is successful, and
we do create a genetically engineered product with favorable traits, is
there a means to commercialize the product? And we try to think about
this before we ever start the research, because if it sits on the shelf
it doesn\'t do anybody good, and so a waste of our investment, your
investment, because these are public dollars.

So what kinds of decisions have we made using these criteria? If you,
\-- there are really three categories of traits that we have been
pursuing using genetically engineered, and of all the 1,200 or so
projects, research projects, in ARS, only 17 of them actually are
engaged in genetic engineering of specialty crops. About half of that
funding actually is pursuing disease-resistant traits, in 10 of the 17
projects. And in all cases those are diseases for which there was no
naturally occurring resistance, and they are deemed serious enough that
the industry is threatened without these traits.

Three of those projects deal with nutritional quality or naturally
occurring toxins in foods to try to remove them, and four of those
projects deal with productivity, specifically environmental stress
tolerance. Again, without the sources of naturally occurring genes which
might overcome some of the problems.

This is a fairly small portfolio. I\'m sure you\'ll recognize that. Let
me give you some examples of the kinds of genetically engineered
products that ARS has worked to develop. We probably all know about the
papaya which has received a lot of publicity. The papaya ringspot virus
threatened to eliminate the entire industry in Hawaii. And the public
sector, including Cornell, ARS and the University of Hawaii, partnered
to develop a genetically engineered virus-resistant papaya and collected
all of the biosafety data for regulatory purposes.

The companies such as Monsanto, provided no-cost licenses for their
technology so that this could proceed. They were actually quite
generous. They recognized that they were not going to be involved in
papaya and that there was no reason why they should deny us a license in
order to pursue these goals. And so that was a big part of the success
with papaya, that the companies were very generous in their intellectual
property.

These varieties have been very successful. They\'re highly resistant and
they\'ve been widely adopted in Hawaii. You may know that much of the
Hawaiian papaya crop is shipped to Japan where they\'re very valuable.
And Japan has a zero tolerance policy for genetically engineered
products. And the Hawaiian Department of Agriculture has been overseeing
a protocol that all packers and growers must adhere to in order to
strictly segregate the two products. And that has been working very,
very well so far. So the Japanese market has not been lost even while
they have been growing these plants side by side.

Let\'s talk about raspberry. The raspberry bushy dwarf virus is another
one of these diseases with no naturally occurring resistance. ARS
scientists in Corvallis, Oregon developed a virus-resistant genetically
engineered strain at the request of growers, and are collecting
biosafety data in preparation for eventual regulatory review of this
product.

Now if you look at the top two rows of the raspberries, the one on the
top left is the genetically engineered resistant product, the one on the
top right is the conventional product in the absence of disease
pressure, and they\'re both full and firm and high quality fruit. If you
look at the ones in the bottom, these are the ones that are infected by
the virus. You can see that they\'re small. They\'re misshapen. The
yield is lower too.

And since quality is just about everything in terms of the market value
of these products, these raspberries are just not suitable. And so this
is one that is sitting on the shelf. We\'re waiting a time when the
growers and others decide that it is appropriate to move forward, and
also, when there is enough data to prove that, in fact, they are safe to
submit for regulatory review.

The potato is a very interesting example. Leaf blight is a disease that
reappeared in the 1990s. It\'s caused by Phytophthora. It\'s the same
disease that caused the famous Irish potato famine in the 1840s and
changed the demographics of the United States because millions and
millions of starving Irish immigrated to the U.S.

This disease has been controlled for many, many years by a systemic
fungicide, metaaxile. The new strain is considerably more resistant to
the fungicide than the old one. And so there are real problems now in
trying to control leaf blight, and if you\'ve ever had potatoes in your
storage bin in your kitchen which are infected with this, you know they
can turn into kind of a soupy mass of brown liquid and it\'s very
unpleasant.

At any rate, ARS partnered with the University of Wisconsin, our
scientists in Madison, to develop blight resistant germplasm in using
genetic engineering technology, which happens through protoplast fusion.
It worked very well. They then used that to isolate the resistance gene
from the very wide cross which would not have been possible without the
protoplast fusion. And the resistant germplasm is being used in variety
breeding. In test plots in Mexico that have been very, very successful
providing resistance to the late blight fungus. And if you look at the
bottom picture there, I suspect we can all pick out the ones that are
resistant and the ones that are susceptible.

That has also, it\'s still in development and there is not yet a
suitable variety, much less one that is ready to be, has enough
biosafety data that we would be submitted that for deregulation.
Gladiolas. There\'s a lot of interest in genetic engineering of
ornamentals where appropriate. Obviously, in part because it\'s not a
food crop and so many of the safety issues that concern the public go
away.

We\'re still left with environmental issues, of course. But with floral
bulb crops such as gladiolas, virus diseases are the greatest production
problem. And these are truly very high value crops, very attractive
targets we\'re trying to overcome some of these diseases. If you, \--
ARS is actually developing virus-resistant genetically engineered
gladiolus lines, and if you look at the pictures that we have on the
screen here, they are, the glads are subject to virus diseases that
cause stunting, as in the upper left picture, and streaking of the
flowers, as in the lower left picture.

Now these are very serious quality defects that essentially destroy the
value of this extremely high value crop. The yellow glads on the right
are the genetically engineered virus-resistant ones and they\'re
beautiful. And so this is a target that actually seems fairly attractive
to us and is supported by the Society of American Florists.

Well, what are some other examples of ARS decisions that have been made
with regard to research on GE specialty crops? The plum tree, ARS in
Kearneysville, West Virginia has developed a genetically engineered plum
tree resistant to the plum pox virus. This is a very serious stone fruit
disease which is endemic in Europe and it seemed only a matter of time
until the virus would arrive on the shores of the United States and it
did so a few years ago and is now present in the mid-Atlantic region,
and so having this resistant tree is very timely.

It\'s currently undergoing regulatory evaluation based on biosafety data
that have been collected by ARS, because this was an urgent matter that
did require that the data be available and this tree be made available,
even though we do not have at this point a private partner to help
invest in that research.

The rose. This is another very attractive target because the rose
probably accounts for half of all the value of cut flowers. ARS did
develop procedures for the genetic transformation of roses and then we
transferred that technology to the private sector, which is very active
in creating transgenic roses. And I know that this has been in the news
somewhat recently. One company has been working with researchers at
North Carolina State University and elsewhere in order to use this
technology. ARS is no longer involved because in fact there are plenty
of others who are and there\'s really no need for us to be in
competition with them.

Citrus. Now here we have an upcoming problem of unimaginable severity.
Citrus greening has just entered the country and threatens to wipe out
the entire Florida citrus industry. There is no resistance to this
disease, which really has spread worldwide at this point. And so there
is no choice if you want to save the Florida citrus industry, we are
most likely going to have to turn to genetic engineering to provide the
resistance. And it is, and so this is one that\'s very urgent, and in
fact, we are just beginning this research to follow this pathway.

We believe there will be some fairly simple and safe solutions to
provide resistance without providing any environmental or food safety
threats, but we\'re a long way from actually getting to the point where
any product can be evaluated. And lastly, I want to mention turf
grasses. When the opportunity came up ARS declined to participate in
development of herbicide-tolerant turf grasses for a number of reasons
that I showed you earlier.

There is private sector activity, and they really don\'t need us. We
really didn\'t see any great good that would be pursued by our
participation in it, so we have not been involved in any of that. And so
the take home points that I want to leave with you are that ARS is
managing genetic engineering in specialty crops with case-by-case
decisions based on strict criteria, including the probability of
commercial use. And if there is very low probability of commercial use,
there\'s really no reason for us to get involved. And all of these
criteria are considered before we ever go into the laboratory and raise
the first test tube.

It\'s clear that flow through the ARS pipeline is just a trickle. There
is not very much activity going on compared to conventional breeding.
This reflects the priorities of our stakeholders and the public whom we
serve. But we also believe that genetic engineering will have an
important role with improvement of selected specialty crops when
circumstances warrant it. Especially when other approaches such as
conventional breeding fails. And so we really do not want to abandon the
whole idea and tell you that it\'s not appropriate for specialty crops.
In some cases clearly it is, and it\'s the decision-making process to
figure out when those opportunities are in front of us, which is the
most important part of the process. Thank you.

MS. SULTON: Do we have any questions we\'d like to, Steve and Bob?

MR. PUEPPKE: You mentioned early on ARS deciding to use biotechnologies,
use the technologies. Could you help us understand how those decisions
are actually made? I could imagine everything from a council of elders
in Beltsville. I don\'t think you have, but \--

MR. RADIN; Well, that\'s not too far from the truth. We have about a
hundred laboratories distributed around the country, and we have a
matrix management. There is line management dealing with facilities and
personnel and those issues. And there is program management which is the
National Program Staff in Beltsville, of which I am a part. We have
about 25 National Program Leaders, and all program-related decisions
such as that, all program priorities are worked out through the National
Program Staff. And so we are the Technology Advisory Staff to the
Administrator of ARS, and we handle exactly those kinds of programmatic
issues.

So when I say that ARS makes decisions, of course the Administrator
makes those decisions, but it\'s with the advice and counsel of this
National Program Staff. In other words, people like me.

MR. PUEPPKE: And it gets to other sorts of, I mean, so the staff would
say, this problem or this position will be defined in such a way that
certain technologies shall be used and other technologies shall not be
used to solve the problem?

MR. RADIN: Well no project actually is approved and becomes operative
without our signatures. And so we discuss with the scientist and with
our stakeholders and anyone who can bring some light onto the issue, so
what is the most appropriate way to go. And as we have with many, many
industries, they say, you know, we will not use genetically engineered
seeds and when that\'s the case, we certainly take that into
consideration. That\'s a very major consideration if there is almost no
likelihood that it will be used. Does that answer your question?

MR. PUEPPKE: Well and then just a brief follow-up. Would those sorts of,
and I understand the need to have those discussions to make those kind
of decisions, are that kind of process followed also for other
techniques or other technologies that scientist might use, or is there
something unique about biotechnology that causes these sorts of
procedures?

MR. RADIN: Well, I wouldn\'t say that there is absolutely nothing else
that requires these considerations. But, of course, a process by which
genetically engineered products become commercialized is quite involved
and requires considerable investment. So it certainly receives more
attention than some more conventional types of products.

MR. HERDT: You indicated that most of the Hawaiian papaya industry has
gone to the genetically engineered papaya. You also indicated the
Japanese, it wasn\'t clear, are they importing the genetically
engineered papaya or they are not?

MR. RADIN: No, they are not. They are not. And in fact they actually
have inspectors in the packing houses to be sure that there is strict
segregation.

MR. HERDT: So where is the papaya going?

MR. RADIN: It goes to the islands and it comes to the mainland U.S. Let
me make one more comment about the papaya, if you will. Which is that
all the conventional papayas are at risk from the disease which is
vectored by an aphid. The growers have none found that if they plant
buffers of the resistant papayas around orchards of the susceptible
ones, that this protects them from the disease, and so instead of 100
percent transgenic papayas, they are able to coexist with about 50/50
and that\'s how they\'ve been able to continue producing the
conventional papayas for shipment to Japan.

It requires some very, very careful management in the orchards by the
growers and in the packing houses. And, as I say, the Japanese have
inspectors in those packing houses to make sure that the protocols are
strictly followed. It has worked marvelously well. It\'s a great example
of coexistence which is a topic I know you\'ve been talking about.

MR. DYKES: A couple of questions on the papaya. Are you seeking Japanese
approval for papaya?

MR. RADIN: Yes, we are. They are doing their own biosafety tests and to
the best of my knowledge no decisions have been reached.

MR. DYKES: And a couple of other questions. You made a couple of
references to conventional breeding and if you didn\'t use genetic
engineering conventional breeding could be used. Could you give us some
examples of where you\'re using conventional breeding to work on
different traits and maybe a little bit of information about what
you\'re doing relevant to improvements in basic germplasm and public
varieties of seed varieties? That issue came up yesterday. I think it
would be helpful if we knew a little bit better about what ARS\' role is
in public varieties.

MR. RADIN: Well there may be no better example than our laboratory in
Madison where we do breeding of carrots and onions, as well as the
potato work that I mentioned to you. All the carrot and onion breeding
is classical conventional breeding. There\'s a great wealth of
variability for needed traits there, and that has worked very well.

MR. DYKES: Yes, conventional breeding to do what in carrots and onions?
That\'s what I guess I\'m after.

MR. RADIN: Well disease resistance, and flavor of healthful
constituents, carotenoids for example, the actual content of carotenoids
in carrots has increased by at least a factor of two over the last
decade or so. This is not my area of expertise so I hope you won\'t
quote me on that, but I know that it has increased substantially. Fire
blight in apples. Obviously, that\'s a major problem. Everybody knows
about that. There is, apples are not easy to breed. There certainly is a
wealth of variability to use and that\'s a major goal of ours without
genetic engineering, at least so far.

MR. DYKES: And then my other question is on the improvements in basic
germplasm in major crops, soybeans for example. Could you share with us
what you\'re doing in terms of just research and improvements of basic
germplasm in soybeans, and ARS\' in public varieties?

MR. RADIN: Well, because there is a very active seed industry in
soybeans and cotton and corn, we certainly are not developing varieties
for commercial use. We limit ourselves for the most part to work that
I\'ll label as upstream. Things that for-profit companies really cannot
engage in because it\'s not clear where their profit would come from.
And so we\'re doing some very basic identification of useful germplasm
characterization, transferring traits into materials suitable for
release for use in breeding programs to develop varieties. You can name
a couple of obvious examples like the soybean cyst nematode is a major
pass the, costs the soybean industry over a billion dollars a year, and
so if there\'s going to be identification of resistance sources for
that, it\'s going to be the public genetic sector that does that. And
obviously a new one, soy bean rust has occupied a lot of our attention.

MS. MELLON: I was wondering whether ARS had any investments in genomics,
and having, in sequencing of the genome of the specialty crops, or
whether someone else makes those investments?

MR. RADIN: Yes, we do, although it\'s probably not as nearly as
extensive as we would like. And sequencing and genomics in general is a
vast activity that requires a lot of money and these are best undertaken
in partnerships. And so ARS does participate in partnerships to do some
of this basic genomic work such as, for example, sequencing the
rosaceae, a genome in the rosaceae to use as an example for genetic
advancement, and there are a tremendous number of important rosaceous
crops. And we don\'t have that. In general, the specialty crops are
behind some of the major crops. Obviously rice is already published. So
we do participate in that, but to say that ARS is doing this on its own
I think is probably a misstatement.

MS. MELLON: And then other question. It seems like some of the most
attractive uses of genetic engineering are for disease resistance, for
example, virus resistance. But virus resistance \-- well, some of the
most attractive applications are disease resistance, for example, virus
resistance. But virus resistance is also one of the applications of
biotech that raises real biosafety concerns, especially from the point
of view of creating new and worse viruses.

So I\'m interested in whether you\'re able to kind of influence the
agenda over at the risk assessment program run by USDA so that that kind
of risk assessment is being funded, you know, in parallel with kind of
projects that you see that you would like to be a part of. So that when
products come into fruition there is an adequate risk underpinning for
you to assess risk.

MR. RADIN: Well certainly, you know the Environmental Protection Agency
is in charge of assessing these issues and deciding what is appropriate
for release and what is not. And we don\'t try to influence that.
That\'s not our job. However, collecting data so that they can evaluate
it fairly and appropriately is part of our jobs, and you mention the
risk assessment competitive grants program, I think.

MS. MELLON: Yes, right.

MR. RADIN: That\'s funded about two-thirds by set-aside from ARS
biotechnology project, and those grants are competitively awarded to the
most important, or what\'s deemed to be the best proposals based on
merit, and certainly, virus resistance and its consequences is part of
that. I would also mention to you that we have the substantial
capability and risk assessment research within ARS as well, which is
in-house and funded by appropriated dollars, and so that is the other
side of the coin. And we certainly do have some influence over that. And
in fact, that is one of our major interests.

MS. CRAMER: So John, you talked a bit about the decisions that you make
and the priorities for ARS. Within that did you include things like
Hatch funding and the relationship between the USDA or ARS and
universities, Land Grant universities and sort of my question goes to is
there the same priorities, is there same oversight or involvement and
set of criteria that are used there, and were you covering both, is that
a different discussion?

MR. RADIN: Well, I\'d have to ask you to direct that question to some of
my distinguished colleagues representing the CSREES. They handle the
Hatch products. We\'re certainly, as an agency, aware of research that
goes on in the Land Grant universities and this is, well this is part of
our process, and we again, don\'t want to simply operate in isolation
and duplicate effort.

And we frequently partner with them as well because many of our
locations are on campuses, and may be, I mean adjacent laboratories in
the same building.

MR. SCHECHTMAN: We may in fact have a presentation at a subsequent
meeting from the Land Grant end of things as well.

MS. FOREMAN: Dr. Radin, could you tell me what is the current budget for
the specialty crops in ARS?

MR. RADIN: The total budget?

MS. FOREMAN: Yes.

MR. RADIN: That was in one of my graphics. It\'s about \$191 million.

MS. FOREMAN: Okay. And what\'s the total ARS budget?

MR. RADIN: This year or last year?

MS. FOREMAN: Let\'s use this year, 2006.

MR. RADIN: \$1.1 billion.

MS. FOREMAN: \$1.1 billion. Does that include CSREES?

MR. RADIN: No, ma\'am, that\'s a different budget.

MS. FOREMAN: What\'s their budget?

MR. RADIN: Again, I think you\'ll have to ask the representatives of
that agency.

MS. FOREMAN: Somebody back there just give us a number.

MR. SCHECHTMAN: I think it\'s in the range of \$800 million to a
billion, as I recall.

MS. FOREMAN: And tell me what\'s happened to your budget and the total
ARS budget over the last five years? Has it gone up, stayed the same?

MR. RADIN: Yes, it has gone up. During the years in the mid \'90s when
the federal government enjoyed budget surpluses, we went up more rapidly
than in the last few years. But it\'s gone up oh two or three percent
per year, which is basically flat because of inflation.

MS. FOREMAN: And next year\'s proposed budget?

MR. RADIN: The president\'s budget proposes a cut of \$150 million, I
think.

MS. FOREMAN: From the \$1.1 billion?

MR. RADIN: Yes. It\'s a fairly substantial cut.

MS. FOREMAN: Thank you.

MR. DYKES: I was going to ask some budget questions as well. So Carol
helped me as well. So 390 for major crops, 190 for specialty crops about
\--

MR. RADIN: Essentially correct, yes.

MR. DYKES: \-- about 580. So in other words, about half of the ARS
budget is on plants?

MR. RADIN: That\'s correct.

MR. DYKES: And the other half is on animals, is that?

MR. RADIN: That\'s correct. Well half is on animals and post-harvest
processing of various kinds of products, and a little bit on
microorganisms. And, of course, the other half is also split with
natural resources because we do quite a lot of work on sustainability.

MR. DYKES: And then the other part of my question was, are you, I know
in the years past ARS had been involved in some additional work on
genetic engineering. Are you doing any work on gene use restriction
technology?

MR. RADIN: No. Well, but genetic use restriction technology certainly
has gotten a lot of publicity. We are not doing any work specifically to
try to develop these systems that allow companies to control seed death.
So I guess the answer is no.

MR. DYKES: Gene use technology would not necessarily allow companies to
control seed death. Are we just merely turning genes on and off, genes
of interest on and off, seed would still be viable?

MR. RADIN: We are not using this in order to restrict the use of seeds.
There is, of course, a substantial research interest in technologies
that turn genes on and off. But for other purposes we really have no
interest in trying to restrict the use of seeds through one group or
another.

MR. DYKES: And my question is too, that research area of turning genes
on and off, not nothing to do with sterile seeds. I\'m not asking that.
Are ARS dollars going for turning genes on and off technology?

MR. RADIN: Yes.

MS. SULTON: Thank you very much, doctor.

MR. SCHECHTMAN: I\'ll take a moment to introduce our next speaker, and
our speaker will be Dr. Alan McHughen, and he is a Biotechnology
Specialist and Geneticist at the University of California at Riverside.
And he\'s going to speak to the committee today on a joint USDA academia
initiative titled the Specialty Crops Regulatory Initiative. Welcome
Alan.

MR. MCHUGHEN: Thank you very much, Michael. And thank you all for
allowing me a few minutes of your time. I was feeling sorry for myself
because of various flight delays and other travel. I didn\'t get in
until 2 this morning, so I\'m running on caffeine at the moment, but
then I learned that many of you were out partying until almost that
time. So I\'m not going to get a lot of sympathy clearly.

Very quickly. This is an initiative for recognizing the legitimacy and
the need for developing specialty crops using biotechnology to get
products back to our consumers. The American taxpayer has invested a
huge amount of money in this technology since the early \'80s, and there
are no specialty crops really with the exception of the papaya that is
returning any return on those invested dollars. So a number of people
almost simultaneously and informally were asking the question, what\'s
happened to that investment? Like we know that this is a powerful
technology, but the products, as you\'ve seen from John\'s presentation,
are so far limited to the major field crops. So the primary
beneficiaries being the companies that develop those, farmers growing
them and to some extent consumers, of course.

But a number of people, and you can see them here, and this again is an
incomplete list of some of the people that about the same time
independently, starting thinking, we should do something about this. Can
we use this technology to help the general public and the environment?
So you\'ll recognize some of the names. We have representatives from
different agencies within USDA coming together. We have representatives
from the Land Grant universities, from the 1890 Land Grants, from small
companies and so on.

With the singular focus of asking this question, what happened to our
investment in biotechnology concerning specialty crops? It is a grass
roots initiative. It didn\'t come from the top. These people, and many
others, came together and said, you know, what can we do to stimulate
this? We know that there are benefits. Of course there are risks, but
there are benefits from using this technology judiciously, to the
benefit of the smaller crop commodities. We have support from a number
of different institutions. As you see here it\'s not any one
institution. It\'s not any one segment of the agricultural research
community, or the government.

Federal and state governments are involved. Public and private
universities, small companies, etcetera. So where are they? You saw in
the previous slide the major field crops, soybeans, cotton and corn, and
these are the latest figures from 2005. And then we have a number of
others that have gone through development, various stages of development
and regulatory approval. But really, with the exception of the papaya,
very little market impact.

There is some squash on the market, carnations, flax was on the market
for a couple of years and now gone. and then a number of others as you
saw in John\'s presentation. Research and development since \'83. We
started way back in the \'80s. I know this is a surprise to some. We\'ve
had over 10,000 approved field trials with transgenic plants. Many of
these were developed first of all through ARS. In fact, at one point I
was looking at the stats back a few years ago, and calculated that ARS
was actually the second largest developer of transgenic plants in this
country for field products.

Now those were not all intended for ultimate commercial release. Many of
them were intended to test the technology, to do biosafety studies, to
look at things like gene flow, persistence and so on. Something over a
hundred species, different plant species. It\'s not just four or five.
Something over a hundred have been genetically engineered with various
traits and field tested in that 10-year period alone.

Again, we\'re down to a small handful that are actually in the market
and having an impact. Something over five hundred different genotypes,
different traits, characteristics in these over a hundred species have
been field trialed. But the benefits of GE crops as we say, we have
these different calculations coming for the benefits, reduction of
pesticide use and so on, increased income to farmers, increased yield
productivity from just six crops and three different traits.

So there\'s a huge potential there to expand not only the traits, not
only the species or commodities, but the benefits, to a much wider
stakeholder base. I put this in to remind us that we\'re not railroading
anyone here, and also that the GMO train is certainly moving, and it\'s
going to be very difficult to stop it. Now that many of our consumers
and farmers are aware of the benefits, are aware that we do have a very
effective regulatory system that is able to identify the legitimate
hazards and risks. At the same time, you know, many of the smaller
commodity groups of specialty crops are standing on the platform wanting
to get on this train, but they can\'t.

At the same time there are other commodity groups that want to have
nothing to do with it. I spoke, for example, to the California, at the
Cattle Commission not long ago. And they said, Alan, you know, this is a
great idea, we\'re supportive, but our markets are not ready for
transgenics, simple as that. Fair enough. They said, we know that
eventually they will, but it\'s not today, and it probably won\'t be
tomorrow. In the meantime, please get up and running because we know
that eventually they will. And that\'s fine. Here\'s your ticket for
later.

The obstacles. Why aren\'t these specialty crops on the market? There
are two primary reasons. One is the intellectual property obstacles. The
enabling technologies are patented, heavily patented. Some of the
concerns are legitimate. We can\'t, as a biotechnologist myself, I
can\'t simply use, you know, whatever technology is available and stick
it into a plant and go to market with it. There are restrictions on
that. There are also a lot of perceived issues with what is a patent.
Many people don\'t understand what is a patent? Or what is a variety
registration? Or what is a deregulation?

This is not our focus. Our focus is in the second primary obstacle, and
that is in regulatory compliance. And again, the issues fall into real
issues, real concerns, real obstacles, and also perceived. Among the
perceived include things like you\'ll hear when you talk to people that
regulatory compliance will cost you on the order of hundreds of millions
of dollars. Right. Hundreds of millions of dollars just to compile the
data that APHIS demands before they will let something through. Now
that\'s scary. If you\'re working with a specialty crop, smaller
commodity, there\'s no way a new variety has that much value in it to
justify those kinds of costs.

Fortunately, it\'s not real. There are some real costs. There are some
questions with regulatory compliance. But these are not insurmountable.
Similarly with the intellectual property. As you saw in John\'s
presentation, the intellectual property concerned with the specialty of
papaya was overcome. It was difficult. It took negotiations. But it was
overcome. Many of the enabling technologies are now expiring, the
patents are expiring. And the companies that hold those are willing to
negotiate sometimes.

I was fortunate enough to develop both a genetically engineered crop
variety and conventional mutated variety. This is a, the stack of
documents required to get the regulatory approval for environment
release alone. Whereas in comparison with a very small number of pages,
for the conventional mutant variety. Now I can tell you that, you know,
I don\'t make any money off either of these by the way, I\'m a public
sector scientist, but *a priori*, I knew with the genetically engineered
variety with the concerns were. I knew with the gene was. I knew what
the gene did. I knew it when it was expressed. I know how much it was
expressed. I knew the issues, the biosafety issues, the regulatory
issues long before we did compile most of this information.

For the mutant variety, I don\'t have a clue. The mutant variety is
still out there being grown. I don\'t know what the genes were that
I\'ve changed. It\'s a mutant. There are probably dozens of genes that
were changed. I have no idea what they\'re doing, but that\'s okay. We
don\'t worry about that.

Now, I want to emphasize that the initiative for, Specialty Crop
Regulatory Initiative is not mandated or attempting to change the
regulatory system. We\'ve had long discussions about this. Most of us
can make suggestions on how regulations can be improved, but that\'s not
our focus. We recognize that the regulatory system, as inefficient as it
may be, whether it\'s 99 percent efficient or one percent efficient is
immaterial. The fact is that it works.

It is possible to get things through. And our intention is to get things
through using the system as it is at the moment. We need an organization
to coordinate the effort to get biotech specialty crops through the
regulatory process. There is a pathway there. We know it works, even
though there are only a few examples. But it does function, unlike in
some countries.

We have broad support from all the relevant sectors. We have support, as
you know, from various branches of USDA, the ARS, CSREES, APHIS. We have
the Land Grants, traditional Land Grants and the 1890 Land Grants. State
agencies, small companies, across the board. Everybody that we\'ve
talked to is at least moderately supportive of this. We have not had a
single person say no, this is a bad idea, don\'t do it.

We\'re going to prioritize when we get up and running and we anticipate
operating in a kind of an IR-4- type organization or you may be more
familiar with the FDA's orphan drug program. We\'re looking at products
that will provide broad public good. Broad societal value. And then on a
more technical basis, need an opportunity. Now, you know, we\'re not
concerned with the intellectual property obstacles, but we do keep in
touch with another organization that is looking at that obstacle and
ways to overcome it.

And we keep in touch because, obviously, there\'s a common interest. We
had Kent Bradford at UC Davis, who many of you know, and Greg Bradd
(phonetic sp.) put together a document compiling the various examples of
specialty crops that have been developed in various of our institutions,
yet have not gone to regulatory approval. Have not gone on to the
market. And the document itself is probably 12 to 14 pages long of
different things, from lettuce to carrots to turf grasses to tomatoes,
with different features in them.

Some of these are developed, they\'re sitting on the shelf and they
can\'t go to the market. Other things are still at laboratory stage.
They\'ve perhaps been field tested one or two years, but they\'re not
getting on the market for either intellectual property or regulatory
approval. So the products are already there. We don\'t have to stimulate
the research. We don\'t have to stimulate the research. We anticipate
that some of the developers of these will come to our body, such as they
do to IR-4, and our management team of the day will decide on which of
those products we will actually sponsor and carry through, pilot through
regulatory approval process.

So we want a simple plan as possible. We want it to be efficient, of
course. It is possible. We do have several people who have expertise in
the regulatory process interested in helping us. We know that there are
ways to make it more efficient and that\'s how we\'re going to, to draw
up the plans, first of all. Our formatting, as I already mentioned,
we\'re going to look at IR-4 is a model. The great success of IR-4, we
do not in any way want to jeopardize IR-4. Let me make that very clear.
IR-4 has their own mandate. They\'re pretty good. They\'re very
successful. Everybody appreciates the work of IR-4. We do not want to
dilute that effort by being rolled into IR-4. But we do admire the way
they do things. It\'s been a very efficient and successful operation.

MS. DILLEY: Can you just explain what IR-4 is?

MR. MCHUGHEN: Oh sorry. Of course. Working in the field I just assume
everybody knows. Interregional Research Project 4 is another USDA
initiative to help get pesticidal approval for specialty crops. Again, a
similar situation in that if you\'re growing
something---raspberries---and you need a fungicide, well, you know,
getting EPA and the company who develops that fungicide to go through
that regulatory procedure is very expensive. And there\'s not enough
value in the end crop to justify the expenditure to get the approval of
that fungicide on that raspberry.

So IR-4 will take, and I don\'t know whether they do this with
fungicides and raspberries, I just used that as an example, but they
will consider a situation. When the raspberry growers, raspberry
community comes to IR-4 and says, you know, we really need this
fungicide, it seems to work very well, can you help us get the EPA
approval? And depending on the finalization and the budget and so on,
IR-4 may pick up that dossier and go to EPA to negotiate the approval
based on the data that already acquired, plus whatever data they may
need to acquire to convince EPA that it is safe and appropriate to
release it.

Again, emphasize, we\'re going to work with the current regulatory
system. We\'re not trying to improve it. If other people improve it, and
there certainly are other committees and agencies looking at the
regulatory system and making various suggestions on how to improve it,
if they do that, that\'s fine. We\'ll work with, you know, whatever
changes are in store. But for the time being we recognize that the
regulatory system does work. It is effective in that, in that, if you
use a singular criterion that we haven\'t had any disasters yet from
things that have been released.

How are we going to choose the first few cases? Technology. As we say,
we have to have the product in hand. We\'ll probably not going to go out
and sponsor a new research plan within either a government or university
or a small company lab. There are plenty of products already there. And
we can scan through these and say, you know, which of these will have
the greatest impact? Which of these will be easiest to get through
regulatory? And let\'s go with those.

We\'ll ensure that the people who are trying to sponsor this specialty
crop have the freedoms to operate or the enabling technology licenses in
place. We\'re not going to spend all this money and energy and effort to
get it through regulatory approval only to find out that the people, you
know, didn\'t get their ducks in a row in terms of getting their
enabling technology license.

Again, we come back to broad public benefits. Most of us, not all, but
most of us are public sector employees who are paid by taxpayers, we\'re
responsible to taxpayers. And we want to see some of the benefits of
this technology going back to them in appreciation for the investment
they\'ve made in this technology over the years.

We\'ll take into account things like the utility of the product,
competition. We don\'t want to compete with products that are currently
on the market. I think John mentioned this earlier, you know, the
development of herbicide-resistant anything probably is going to be a
lower priority. The people who develop the herbicides and sell the
herbicides would be more interested in sponsoring that product.
Taxpayers probably not.

We have supportive markets, as I say, probably not going to be at the
pedals (sic). And there are several other commodities, strawberries, for
example. Strawberry people say that, you know, our consumers just,
they\'re not ready for biotech. That\'s fine. But I have letters of
support now from different commodity groups saying, yes, we want this
technology. Are markets are fine with it. Please, please choose us.

The citrus industry. You know, you\'ve heard, we have this citrus
greening coming into Florida. Devastating disease. You know it\'s going
to happen in California, as well as that Tristeza virus and some other
things. Biotech is really the only answer if you want to save the
industry. And our citrus people are very, very interested in having the
SCRI-type organization handle citrus as one of the first cases.

We have plenty of very good products. We don\'t have to try to sponsor
ethical or politically questionable products. We\'re very fortunate in
having a broad base of support. There\'s no political influence in this.
Across the political spectrum we have people saying yes this is a good
idea, run with it. We don\'t want to muddy that water. We appreciate the
support from everyone, and we don\'t want to annoy anyone by taking a
product that for whatever reason they just don\'t think is appropriate.

Practical issues. We\'re not going to, I\'m sure we\'re not going to,
and it would be up to the management team of the day, I\'m sure we\'re
not going to sponsor something that has allergens or toxicants in it.
You know, putting a neurotoxin in sweet corn, I can\'t imagine anybody
doing that in the first place. But it\'s really unlikely that we\'re
going to carry that forward. Not only because it\'s questionable, but
also because of the complexity in the regulatory process. Once you do
something like that, then you have these real legitimate concerns about
the health safety, and that is going to take that much more
documentation to prove that, oh no, that\'s not really a concern, we can
deal with that in the market place.

If I were a regulator looking at that dossier, I would have a lot more
questions and be a lot more skeptical, demanding a lot more money be
spent to develop the data package to convince me otherwise.

Okay. Our current status as we wrap up, we\'ve had a couple of workshops
in the last few years. We were very fortunate to get some seed money
from the Office of the Secretary. We had workshops with some of the
people that I showed in the first slides. Some of the people who are
present here today, and others who couldn\'t make it. As I say, very
supportive.

We\'ve had workshops with the people who are on the ground and have this
interest from the public. We\'ve had a more recent workshop last
November from some of the stakeholders. The handlers, the people who
weren\'t directly involved in the research and development of new
varieties, but more involved in the processing, in the transport, in the
consumption, in the retail, in the marketplace, the consumers, and so on
to say, you know, this is what we\'re doing. Do you have questions or
concerns? Are you interested in supporting us? So we\'ve been proactive
at trying to communicate with people about what we\'re doing. We are
essentially a public agency and we want to be fully transparent as to
what we\'re doing, and we\'re not trying to hide anything from anyone
here.

Our current status, within the whole group, we\'ve had discussions, this
probably in practical terms will only work if it\'s a collaboration
between public and private sources. We do need some money to get up and
running, but we anticipate that we will eventually, I don\'t know if
we\'ll ever become fully self sufficient. But we want to run as
efficiently and with as little cost to the taxpayer as possible.

Mentioned already, we have broad support from stakeholders. We think
we\'ve found pretty well everyone now who would have a direct interest
in the SCRI, including the American Farm Bureau Federation, the American
Seed Trade Association, and a number of other commodity groups that
aren\'t directly involved with biotechnology or crop development
necessarily. As I mentioned, we have some seed funds from the Office of
the Secretary. We greatly appreciate these.

We are putting them to the best use possible by developing, or we\'re
recruiting a consultant to develop, a business and implementation plan.
That\'s the status now. Most of us are not business people. We do have
some representatives from small companies, but you know, they have their
own jobs. I\'m not an expert. I\'m an academic. We recognize where we
don\'t have the expertise, and that is in the business development and
implementation. So we do have a small amount of money. That\'s the
current status. I appreciate your time and attention. Thank you very
much.

MR. SULTON: Thank you so much for that overview. Do we have any
questions from the panel? Brad?

MR. SHURDUT: You mentioned a couple of times the IR-4 program, and I
know from when I did more work on pesticides it\'s a very, very
successful program, and a lot of new products have been brought to
market because of that program. Are you aware of any, well, how is the
progress in terms of working with the federal government on IR-4 and to
them moving that concept forward as it relates to biotech? Is the
government engaged in that discussion? Is it advancing or is it just a
concept at this point?

MR. MCHUGHEN: Well, what do you mean by the government? You know, we
have Bob Holm is one, and he should have been listed on that. I knew I
was going to forget somebody. Bob Holm is crucial. He\'s been involved
with us from the start, and once he had our assurance that we did not
want to undermine in any way what IR-4 was doing, and he actually
recommended that this be a stand-alone, not part, some people initially,
we had initial discussions, well let\'s just roll this into the
responsibility of IR-4. And that, you know, the general agreement that
that probably was not a good idea. Let\'s, you know, IR-4 is a super
example, it\'s a very efficient operation, let\'s not jeopardize it by
putting biotech on their shoulders.

But yes, we do have Bob and other members of IR-4 advising us, I
suppose, because we solicit it. We recognize they\'re a very well run
operation. We would like to follow in their footsteps as much as
possible, also recognizing that they started out very small. They
started out small and they built up over the years, building their
credibility. You know, they\'re a science-based operation. They
recognize the legitimacy of the specialty crops, the marketplace and so
on. And just a very, very good operation. We like them. But no, we\'re
not formally associated with them.

MR. DYKES: I was going to ask, you listed some organizations that have
been supportive, AFBF, ASTA, how about the, more in the specialty crop
like the United Fresh Fruits and Vegetables, the PMA folks, those kinds
of people?

MR. MCHUGHEN: Yeah, we have, certainly PMA has been involved and
verbally supportive. You know, I\'m getting letters, I just got this one
yesterday from the California Lettuce Research Board, saying we are very
supportive of your efforts to get an organization started that includes
both the public and private sectors in order to pave the way for
regulatory clearance of transgenic specialty crops. So yeah, we\'re
getting support.

The onion and garlic people sent me a letter. Other people will send me
an email or just phone and say, you know, what\'s happening with SCRI? I
had a call even from Michigan State. The fellow at Michigan State was
very interested because of the products they are developing and you
know, when are you guys going to be up and running? You know, we have
products that we want you to consider.

So, you know, it\'s very exciting, but yes, we are as much as possible
connecting with the stakeholders as broadly as possible and finding out
first of all whether they may have products, and secondly, if they\'re
not interested, that\'s okay. You know, we can appreciate that. We
understand the marketplace, and, well, try to understand the
marketplace. And we\'re not going to force anybody to come to us.

MR. DYKES: I guess just one follow up comment on that. You mentioned
that the folks on this have been the regulatory step and I agree that\'s
the first step of that. But I was also heartened by your comment about
once you get the regulatory approvals, the business plan and the
business development, because I think as we look at these things, we
look at it from a research and technology perspective and we identify
the gene, then we think we get the regulatory stuff. That whole
infrastructure from the time you get approval until you get that in the
varieties, in the best germplasm, in the hands of producers in such a
way, that\'s a huge piece in there that \--

MR. MCHUGHEN: Well one of the components of the package that the
developers will have to bring to us, is their business. We\'re not going
to waste our time and the taxpayers' money getting this through
regulatory if they say, we\'re not interested in putting that on the
market. So thanks for doing this, but you know, we\'re not going to do
that. We\'re not playing that game.

MR. GRANT: Very interesting presentation. Two questions. One of the
criticisms of transgenics and biotech, you know, modern biotechnology in
general has been that the products have accrued benefits primarily to
the producers. Both John and your presentation mentioned some kind of a
public good assessment that the product would have to pass. So I\'m
curious if you could define that a little bit better for us. For
example, are there any products that you see in the pipeline that would
confer a direct consumer benefit or how do you define what public good
is?

MR. MCHUGHEN: It is broad. And it will be up to the team of the day to
evaluate those. But I can tell you, things like, you know, removing
allergens from common foods, whether it\'s soybeans or peanuts, you
could have the development of crops. You know, in my lab we\'re working
on tomatoes that will grow and produce with less water or less quality
water. And you know, people appreciate that.

You could even argue that many of the products that are currently on the
market are produced with fewer pesticides. And broadly based, most
consumers say yeah, I would support that product. Now the companies
choose not to market it on that angle, but that\'s their choice. So you
can have nutritional benefits, as we\'ve talked about. You know another
project in my lab is to increase the vitamin C content. Most American
consumers don\'t need more vitamin C, but you know, it\'s a nutritional
benefit.

But you know, the world\'s your oyster. I mean, biotechnology is a tool,
and with that tool you can build many, many different things. And it\'s
just up to the imagination of the developers to think of things that
consumers will appreciate.

MR. GRANT: The other one is a little bit more of a technical question.
It is a global marketplace, perhaps less so in the specialty crops than
in the major crops. But, certainly it seems like you have the U.S.
regulatory system in your sights. How about ex-U.S. for products that
have potential, perhaps they don\'t have an active large overseas
market, but have the potential to end up in overseas markets?

MR. MCHUGHEN: You know, that will be one of the discussions from the
commodity groups. You know, if you have a large portion of your product
is being shipped to Europe, for example, you\'re probably going to come
to us and say, you know, our market isn\'t ready for this. If you\'re
more domestic consumption, where with Canada, we\'re in touch with the
Canadians regulatory people there. They\'re aware of what we\'re doing
and very interested by the way and possibly following suit there.

In some developing nations similarly, they would like to see this
because, of course, many specialty crops are grown and consumed in
developing countries, and this will also facilitate their access not
only to U.S. products, but potentially things that are developed there
that might come into here eventually. Although I do emphasize that for
the time being, we\'ve had discussions on this, we\'re looking at the
U.S. That is our area of expertise.

We\'re interested in the overseas markets and being aware that certain
commodities will probably not be appropriate because of the overseas
market. But at the same time, we\'re also aware of the developing
countries and some of the concerns. We have to focus on the U.S. right
now, and I think we\'re very focused and if we can help with some of
these other markets or issues, then fine, we\'ll do that. But our focus
is the U.S.

MS. MELLON: I guess I would just follow up on Duane\'s question by
asking, you know, whether among the stakeholders that, you say you
perceive a lot of demand for your efforts from a lot of stakeholders. I
want to know whether you perceive any demand among consumers? The people
who, and consumer organizations are coming and demanding that we, you
know, provide more transgenic crops than we now do.

MR. MCHUGHEN: I\'m not sure if I\'d say demand, but certainly support.
The demand is generally from the people who have a product in hand and
they want to get it on the marketplace, so I can understand that. But
support, I think is probably a better word for the broad base.

MS. MELLON: I mean, I would just, you know, point out that from the
consumer point of view, you\'re confronting a consumer base that already
has a tremendous amount of everything. An enormous amount of variety.
From the nutritional standpoint our problems, of course, are not too
little, but too much food. So benefits like producing more food are, I
don\'t think they\'re going to register. People understand that we\'re
getting, I think almost half of our food now comes, over half of our
food comes from someplace else.

So in order to kind of make an impression on consumers in a marketplace
like ours, it\'s going to be tough. And I would say it\'s going to be
tough for a very expensive technology that has a lot of, you know that
as you said, has a lot of baggage associated with it. So I would just,
you know, point that out. So I wouldn\'t say that, I don\'t know how to
say it. I think that your effort, to be honest, perceive, depends on
your ability to convince the broad consuming public that in fact
producer benefits are public benefits.

It is not an impossible case, but I really think that that is where the
effort will have to go if it is to be perceived or welcomed even by a
lot of other people who already have, as I said, you know, really a lot
of food. So, I guess that\'s just a comment. I mean people would be
looking for cheaper food, better tasting food, maybe more nutritious
food, but I haven\'t seen in any where, you know, the technology offers
a unique advantage there.

Where I do think it offers unique advantages is perhaps in disease
control, and as I said, again, the idea here would be to convince a
broad public that those are public goods.

MR. MCHUGHEN: One of the, \-- you may have noticed that in the list of
criteria by which we will choose and evaluate the products, we did not
include a market blockbuster. We\'re not marketing people. We\'re by and
large academics, we\'re scientists, we\'re regulators and so on. It\'s
up to the marketplace to choose whether something is, is going to
succeed or fail. So I think we\'re deferring back to the, let the
commodity groups, the processors and so on, to decide, to make a
determination that yes, this product will succeed in the marketplace.
And you know, they may have things, you know, \-- you\'re absolutely
right. We have excess. We have too much food and obesity is a much
bigger problem.

But things coming along like healthier oils and oilseeds or, you know,
that\'s up to the marketing people to, \-- once it\'s approved and on
the market, then it\'s up to the marketing people to convince the
ordinary, you know, mom and pop to buy this product and benefit from it.
And if they don\'t, I mean, that\'s a failure in the marketplace. But
it\'s not our expertise, so we didn\'t even want to take it on as one of
the criteria other than having a business plan that it will at least be
presented to consumers such that consumers will have a choice to buy it
or not.

MR. KALAITZANDONAKES: Two of our speakers have been trying to get
comments in so I would like, \-- I want to follow up the question that
Duane made and Mardi made, and I\'m not really sure whether you are the
right person to *per se* answer this, but I think this is a broader
issue that deserves some attention, which as an economist, as a food
economist I am absolutely opposed to the idea that consumer benefits
only come in the form of quality enhancements. In fact, if we look, you
know the last 60, 70, 80 years of history, the biggest benefits that
have come to the consumer, have come in the form of making a greater
quality, large number of products available to the marketplace, better
safety and that ultimately lower price.

So if we look at where gains have come to the consumer, and the broader
market, they have come in the form of lower price first and foremost.
And most of the benefits that have come from R&D in food and
agriculture, have actually accrued to the consumer. And these are very
well known, very well quantified benefits for many, many years. And so
I\'m very puzzled by the concept that some how unless we create products
that are quality enhanced, whether it's specialty oils and so on, that
somehow the consumer benefits are not there.

So I would like anyone who has a perspective of this to jump in and give
me a justification why that might be the case.

MR. SCHECHTMAN: If I could interrupt for just a second. That\'s actually
a discussion that we have had at fairly great length in the course of
developing the report that we\'ve just finished, and I have no doubt
that we will have the discussion again. But, I think what I\'d like to
do is defer that committee discussion for right now.

MR. KALAITZANDONAKES: Michael, although I would like at least Alan and
certainly Bill, but both of them actually used this as criteria for
prioritization. They both talked about, you know, both in terms of the
R&D programs that they\'re using, but also in terms of what they are
going to bring forward as consumer benefits or public benefits being
primary criteria. And certainly in that context, the concept that
cost-reducing technologies might not be appropriate choices, and I
don\'t put words in anybody\'s mouth, might not be priorities. You know
that quality enhancements might be more appropriate.

And so in that context, I would like, you know, some reaction, because
originally those were presented as arguments in this presentation.

MR. MCHUGHEN: Well, why don\'t I take that off and then turn it over to
John for his perspective. My view is in terms of broad-based benefit,
that is in the context of contrast to development of say a herbicide
resistant crop where the primary beneficiary is the company that makes
that herbicide. Why should all society contribute their tax monies to
support a product that will benefit one company?

So when we say broad-based, at least to my mind, and this will be, you
know, up to the management team of the day, they will be looking at
things where virtually everyone has some benefit. Now whether that\'s an
improved-quality oil, less cost to a final product because of
efficiencies in production, you know, reduced salmonella in poultry and
eggs, whatever. That\'s up to the marketplace to decide. But that is
more likely to capture our attention than something that will be of
benefit to one company because they will sell their one product. So
that\'s my perspective of that broad base.

MR. RADIN: Well, if you\'ll forgive the expression in the context of
specialty crops, ARS has cherry-picked its problems. We have identified
those where we really believe that the alternative to genetic
engineering was drastic, citrus being a good example. We believe that
it\'s a choice of do you want your oranges or no oranges.

You may have noticed, or you may not have noticed the price of orange
juice futures, orange juice concentrate futures has doubled over the
last few years. This is symptomatic of what\'s happening, and so though
there\'s certainly a great consumer benefit in preserving affordable
access to citrus fruits, and so you know, we really feel that there is a
public good to projects like this, and we have been judicious in our
choice of targets so that they will be relatively widely accepted.

MR. POLANSKY: Well, first of all I just wanted to thank you for the
presentation. I think it\'s very interesting and I appreciate the
efforts, because I think it is important that those of us that consume,
purchase products have some ability to choose whether we have a higher
quality raspberry or whatever it might be, and whether there\'s two
percent or eight percent, or whatever the market share out there of
those of us that are looking for that opportunity to choose, we
shouldn\'t be restricted because there\'s an issue with getting that
product to the marketplace.

Certainly, there\'s a demand for organic product, for example. And I
have no issue with that, and that choice needs to be there. But there
are consumers that would like some of the choices that you\'re thinking
to and we ought to have the right to make those choices and selections
in the marketplace as well. And so I appreciate your efforts is what I
guess I\'m trying to convey.

MR. MCHUGHEN: Thank you. I certainly agree with those comments. On a
personal basis, you know, I think we do have to, I support our organic
community and let\'s make sure that those choices are there for the
consumers who wish them. At the same time there are other choices that
should be available for other consumers. So I do want to make one point.

I\'m not sure that I emphasized it earlier, and that is, we are not in
any way going to subvert the health or environmental safety. We\'re not
trying to circumvent regulation. These products are going to be just as
safe both for the environment and for the food supply, for the feed
supply as the major commodities that go through \-- this is, these
products will go through the complete regulatory package. We\'re not
trying to get in the backdoor.

We\'re not trying to slip anything under. Absolutely, job one is to
ensure the highest degree of confidence in the safety of these products.
Just in case that didn\'t come across.

MR. KREMER: A short question, maybe a short answer. Talk a lot about
commercialization in private partners, have you ever taken on something
that ended up being resolved in a purely public variety, in other words
not tied to any, no extra property, patented or you know, no cost
license, that type of thing?

MR. MCHUGHEN: Well, yeah, my transgenic flax was entirely public sector
brought. It was on the market for a couple of years. It came off because
much of the flax goes to Europe. Europeans didn\'t want to have anything
to do with it. Didn\'t want to jeopardize the entire flax commodity, so
it came off. But yeah, that was entirely within the public sector.

MS. CRAMER: I was wondering Alan whether or not you could tell us what
you think is the biggest hurdle in moving some of these things forward.
So where do people get bogged down? Is it on the field trials and the
repeat of productivity? Is it in tox trials? Is it in compositional
analyses? What are the pieces of data that are sort of most cumbersome
for the small market crops to get through?

MR. MCHUGHEN: Well, most of those questions, you know, think back to my
slide of the big stack of documents. We would have done that stuff
anyway. Just being judicious and prudent to ensure it was safe. Even if
we didn\'t need to do that, as again, responsible citizens, we didn\'t
want to release something that was going to cause harm later on. We
would have done all of that.

Probably the biggest obstacles are the perceived obstacles. The
misunderstanding of what is a patent. The misunderstanding of what does
regulatory compliance mean, and people are scared to death when they
think, oh I\'m not going to even develop a product if it\'s going to
cost me a \$100 million to get it through regulatory. And overcoming
those kind of perceptions, I think, will be a major achievement.

MS. CRAMER: So just to follow up on that, it seems that a component of
this organization may be significant is going to be in education?

MR. MCHUGHEN: Sure.

MS. CRAMER: Both to the producing people and then potentially also and
interfacing with the public.

MR. MCHUGHEN: When I talk to people who are skeptical of the technology
and you know we have a discussion of the issues, very often it comes
down to, you know, I\'m not particularly worried about the safety of
these products, but I don\'t like the idea that, you know, that a small
number of companies has a virtual monopoly on all of it. And you know,
where are the public sector products? Where are the broad societal
benefit things from ARS, from our universities and so on? That\'s a
primary concern as well.

So yes, educational. I mean, I\'ve been an agricultural scientist for a
long time. I would love it if our society were simply better informed
about what farming is and how our food is produced. So I mean,
biotechnology has certainly brought the issue to the forefront, but
there\'s a lot of misunderstanding about what a farm does, and I think
it\'s better for society if they were more knowledgeable of the real
traditional processes as well as the new ones.

MS. MELLON: One very quick question on the issue of choice. Are you all
going to take a, \-- are you going to address the issue of labeling? I
mean you\'re talking about whole foods here, so labeling will be a big
consumer issue.

MR. MCHUGHEN: We are not going to address regulatory issues. We haven\'t
discussed this in our team, so this is my impression, but our policy is,
we\'re going to work with the regulatory system as it stands now, and my
understanding of the FDA and regulatory on that side of it is that they
mandate labeling, mandatory labeling is based on the composition of the
food, whether there are toxicants, allergens, or nutritional changes on
the physical components of the food itself. And you know, that\'s a
regulatory issue. We\'re not going to get in the regulatory fight with
them.

MS. SULTON: If we could just take a brief, say 10 minute break and be
back at about 20 minutes to 11, great. And we\'ll talk to you about our
next steps.

(Whereupon, a brief recess was taken.)

MS. LAYTON: As we get started I\'d like once again to thank both of our
speakers today. These were very informative and enlightening talks. I
know that we all, members of the committee all appreciated your time,
effort and the option for redeyes that some of you took. Some of you
probably just had to come through the commute here in D.C., but we
really appreciate your coming here and doing these talks for us today,
and hoping to tee up what we\'re about to start, which is to kind of
look at the questions that we\'ve been asked and to formulate what those
really are going to mean to our charge as a committee, now we\'re going
to accomplish this, and come up with a work plan.

Cindy is going to get the materials on the screen for us and Abby is
going to take us on a discussion, facilitate the discussion. Michael do
you have any words of welcome as we start back or any comments that you
want to make before we start back?

MR. SCHECHTMAN: I guess we\'re going to start on the specialty crop one.
I guess the one comment that I would make that I think was highlighted
from Carol\'s words, which I think we\'re going to be looking at in a
minute, and from a lot of discussion around here is the central question
of what\'s the public benefit? And I think that was around a lot of the
discussions that many of the questions came from. I think that\'s going
to be a, however it makes it into the topic or into the work plan
that\'s going to be, I think, a very key part of this discussion, is my
observation.

MS. SULTON: And I had one question about that as we go into specialty
crops. The specialty crops crop description that was in the law, and
this is the tree person talking, says a few things, but does it include
things like, for example, my chestnut tree it produces a nut, but it
would not include an elm tree because it\'s a shade tree?

MR. SCHECHTMAN: I think it\'s a fair question to ask whether the scale
of the group of things that you want to look at, whether it\'s by
definition of the specialty crop or whether it\'s by definition of what
the committee thinks they can get their arms around, or whether it\'s by
definition of where public goods are. I mean there are three different
ways that I think that could come in.

MS. DILLEY: I would like to start the conversation back a step. Because
the charge is for the committee to deliberate on these two topics for a
year, which basically means three to four plenary sessions at most. So
that puts parameters around what we\'re going to do right off the bat.
And one of those topics the Secretary has asked for recommendations on
the specialty crop, the first topic, if you will, if you\'re looking at
the two on the sheet, and I think is what Cindy\'s putting on here. So,
that\'s one. That\'s a parameter right there.

We\'ve got a fairly limited amount of time to do what we need to do on
these two topics. So with that in mind, what I\'d like to do is take the
specialty crop one first because it\'s fresh in our mind and we just
talked about it, information and try to put our hands around that.
Michael you just mentioned that and what I suggest is for, we have until
noon, so I\'d say why don\'t we try and take 45 minutes per topic.

(Discussion off the record.)

MS. DILLEY: Take about 45 minutes for one because I think we need to be
relatively on the same page. I don\'t want to necessarily wordsmith
right off the bat. I think we need to drill down and pick off particular
pieces or dimensions in each of those topics so that we know what the
big parameters are and trying to get our hands around this. Then we can
start to make a work plan and you can wordsmith it following this, but I
think just trying to pin down the concepts of what are we trying to do
in the time allotted to us would be helpful.

So on the first one, for example, so specialty crops, one piece of it
that we need to talk about, we can start there or not start there is
what Pat raised, which is the definition included fruits, vegetables,
tree nuts, dried fruits and nursery crops. So do we want to take all of
those or do we want to take a portion of those? How do we want to look
at those? The other is, how do you define public benefits? Some of that
discussion came up. I think some of the ways that the, \-- currently
it\'s phrased is looking at domestic markets, rural communities,
developing nations.

Carol brought the issue of the safest, contributing to the safest and
most nutritious food supply for the American public, I think is the way
I have it. But I\'m sure there may be other things that need to be in
that mix. So the whole discussion of how are we trying to define that
and what are we trying to do with that is important. And then I think it
has avenues of what USDA\'s actually doing with that, whether it\'s
selecting research, transferring research, or what exactly is it that
USDA is doing to realize a public benefit? So those are three chunks in
that statement that we need to get our hands around of that, and what we
want to do.

MR. DYKES: I guess if I look at both of the bullet points in trying to
determine what\'s going on. The whole first one, although worded in an
awkward way in my opinion, it talks about all the things it\'s not,
which I guess if you look at what\'s left, the first one is basically
specialty crops, because it says it\'s not, other than, large scale, so
to me, as I read the first one it\'s, what are the amenities of
technology transfer or actions by USDA that would result in production
of specialty groups that would have impacts on rural communities,
domestic markets, developing nations? So to me the whole first one is
about what\'s the role of USDA technology transfer and actions? Whatever
those may be defined to be on specialty crops.

MS. LAYTON: If we define a specialty crops because since they didn\'t
say specialty crops, it could include fiber. Pardon my trees.

MR. DYKES: No, I agree with you, Pat. I\'ll leave that out there, but
again, if you look at the way the first one is worded, it excludes a
whole bunch of things and what I think it would be better to do is look
at what\'s left after you take all those exclusions out. Excluding all
the things that it tries to exclude, somehow or another you have a
subset of what I would largely define as specialty crops, whether
they\'re fibers, trees, whatever, we can get into specifics. But the
first one is going at what\'s USDA\'s role in technology transfer, again
or actions. I don\'t know what\'s meant by actions on specialty crops.

The second one then to me is introduces a whole new concept of
coexistence as it relates to the development of the use of specialty
crops for non food uses.

MS. DILLEY: Michael, could we stick to the first one first and then come
back to your second one, or are you trying to link them together?

MR. DYKES: Well, I\'m just trying to get out on the table what I think
the bits and pieces of this is and where lots of the confusion is.

MS. DILLEY: Okay, why don\'t you put it out there and then what I\'d
like to do is take one at a time.

MR. DYKES: Okay. Maybe I can reserve the second one. The first one to me
is, goes at, so what\'s the role the USDA in terms of tech transfer or
actions on specialty crops, and then we\'ll get to the second one when
we get to the second one.

MS. MELLON: I\'d like to just raise the question of, I mean, since this
is a big topic, whether we can really take on this notion of somehow
benefits going to developing nations. I think that we didn\'t hear any
presentation on it. I really, you know, my impression is that USDA\'s
research agenda has only a very small effort directed toward the
agriculture of any other nation, and it just seems to me to raise, to
bring in a quite, a separate set of very big issues that we, that I
would argue we probably can\'t really get through in a year in addition
to the other things that are on the plate. So I would offer for
consideration that we might not want to, you know, try to talk about
developing nations.

MR. HERDT: Well, I don\'t\' know who put it in, the charge, in fact I
think any actions on basically any crop under the U.S. has spillover
into developing countries. So if there\'s some, some things are
approved, some things are not approved, there\'s going to be an impact
on developing countries. You could argue that the advice means certain
non, certain of the commodities that have not yet been genetically
engineered that are more important or less important in certain
developing countries, but doing a, I think having an effort to
specifically, try to identify benefits to developing countries as a part
of the activity I think is pretty challenging.

On the other hand, whatever we do, will have some spillover for
developing countries, and so, you know, you take it out it\'s not going
to hurt much.

MS. DILLEY: So having it as a consideration but not part of the focus in
terms of public benefit, being public benefit writ large maybe makes the
best sense. The way you said it. I mean, you\'re going to have an impact
and if you focus on domestic markets and looking at public benefit,
looking at the U.S., but that obviously has impacts more broadly, and we
need to take a look at that anyway.

MR. HERDT: Right. As long as I\'m talking I want to make, since I have
the floor. I don\'t know what positive impacts I think should be on.
Positive impacts on domestic markets. I don\'t really know what that
means. I really don\'t understand what that means. Some people might
say, well it reduces the price of products in domestic markets. Other
people would say, it increases the prices of products in domestic
markets. You know, then you can play with quantity. So I don\'t know
what that phrase means. I also object to the use of the word public
good. It\'s a very special term that has a very special meaning in
economics. Public benefits is fine. Let\'s not get into public good.
Take it out. Otherwise it\'s too complicated.

MS. DILLEY: Okay, that\'s good. I mean that\'s good to know that that
has a particular meaning to it.

MR. KALAITZANDONAKES: So just for clarification. Transfer to me means an
existing R&D portfolio or technology portfolio that you\'re trying to
pass out, and take it in the market and so are we talking about here
what are the best avenues for taking an existing R&D portfolio and
making it as broadly available and as broadly, having the broadest
possible impact, or are we thinking R&D targets in general?

MR. SCHECHTMAN: I think it\'s a fair question. The USDA has a very
substantial role mandated to it by Congress to take its innovations and
when they are patented and found to be useful, to offer them for license
to the private sector. So there is, and there is a clear track on which
that has gone. It has not gone, in many instances apart from the papaya,
on genetically engineered specialty crops. There are other things that
are out there that, you know, they could be, it could be technology
transfer to the private sector. It could be some, it could be more
general, it could be some broader use of technology. It could be
specific applications of things that are on the shelf.

It could be, you know, directions towards particular things where there
is, a committee says there\'s public benefits. It could be things that
have nothing to do with the technology transfer part of that. I think
that\'s something that in your own prioritization, I mean, my sense of
how this would work is that there would be a lot of ideas coming out of,
you know, what kinds of things are needed that will be public benefits?
And then there\'s going to need to be some sort of metric for ranking
those things.

MR. DILLEY: So Michael, let me ask it a little differently. I think I\'m
getting at your question, and I have one point. There is obviously \--
technology transfer is distinct by other actions that USDA could do. So
at the end of the day, at the end of the year do you want this
committee, does the Secretary want the committee to give, is there an
expectation that there\'s going to be a recommendation specifically to
technology transfer, or is part of what the committee needs to do is
sort through actions more broadly defined and make recommendations as to
what action should be focused on and why?

MR. KALAITZANDONAKES: Yeah, let me, \-- absolutely, and let me add just
that qualification to my question here. That if we are going to talk
about just tech transfers based on the presentation that we heard
earlier, you know, there is already a portfolio which is not
particularly large at USDA, especially in biotech, that you know, one
could consider here is the existing R&D portfolio and how do you take
this out of the market the best possible way? And that would be in my
book tech transfer. If we are talking about what are the largest
potential benefits that might come from potential R&D, you know, now you
have a much, that could come out of the other actions, whatever that
means.

Then all of a sudden you\'re opening up to much large set of
considerations. So I\'m just trying to figure out where we are with
this.

MR. SCHECHTMAN: I mean I think it\'s in part the larger set of
considerations. We\'ve heard today from Alan that there is a program
that is going to be doing some of this effort having to do with public
benefits via some identified projects. I mean obviously ARS has some
projects, and it will be interesting to hear and CSREES things that are
going on in the universities that are also involved in these things. But
it\'s not only technology transfer. USDA is involved in the whole range
of agriculture. The whole range of stages of agriculture. Not only
moving particular products, but also at the rural level. And I think
there is range of places where you could be, where the committee could
think that there\'s something useful to be done.

MS. DILLEY: So basically you\'re saying Michael that the expectation is
not so much that we focus specifically on technology transfer, maybe one
of the actions that the committee decides to whatever process? I mean
the news is that we need, a first step would need to be prioritization
of actions that the committee wants to focus on. That\'s part of our
effort to \--

MR. SCHECHTMAN: Figuring out what the range of kinds of actions is.

MR. BUSS: Well my point was really dealing with the ambiguity of the
question as, or the issue here as to what\'s the primary point. Because
if you were to read aloud and chose where you place your inflection, you
could interpret that the primary point is to choose those avenues of
tech transfer or actions that are most likely to result in the
production of specialty crops.

Read with a different inflection, it\'s all about how do you resolve in
producing crops with the greatest positive benefit or whatever you want
to choose. So it\'s going to be approached in two completely different
paths depending on how you read it. But I don\'t see us being able to do
both of those within that time frame.

MR. SCHECHTMAN: Okay, I think the words that are clearly missing in
this, and again, whether it\'s consumer or whether it\'s public
benefits, that public benefits is a really, it\'s not just getting
specialty crops out there. It\'s what can USDA do to get the greatest,
to create the greatest bang for the buck? And bang is not dollar signs
for the buck, it\'s the greatest public benefit.

MR. PUEPPKE: And my comment is to just sort of go back to something that
we talked about briefly earlier, that there are really big differences
in USDA relative to ARS and the model that we heard about versus the
CSREES-Land Grant partnership side of it. And as a Land Grant person I
really see that, and the, it has a lot to do with decentralization out
there in the states and I don\'t know whether to what extent we ought to
pay attention to the Land Grant partnership side of it through CSREES,
but it would be entirely different.

MR. SCHECHTMAN: Yes. I mean, I was thinking that we would have a
presentation about specialty crops, specialty crop research at Land
Grant through CSREES perhaps at the next plenary.

MS. DILLEY: So if you put public benefit, specialty crops and USDA
actions in the bubbles, and one of the pieces you\'re looking for,
Steven, is ARS has talked about USDA actions in terms of their research,
but we really need some background on CSREES, and I don\'t know if there
are other pieces of that, but that\'s kind of, that helps us start to
put our work plan together. I mean, we\'re not there yet, but that\'s
one piece that you would like to see in terms of background to talk
about to get a sense of USDA action.

MR. SCHECHTMAN: Or are you saying that that\'s too much to even think
about?

MR. PUEPPKE: Well, I\'m saying again, as somebody who was at a Land
Grant institution in a state that didn\'t have specialty crops and
didn\'t care about specialty crops, moved to an institution in a state
that did and does, it\'s completely different worlds, and the reality is
that I think the amount of research dollars that USDA is putting into
the CSREES Land Grant side is roughly equivalent to the ARS and that was
the rule of thumb. So I don\'t know how to get our hands around that,
but we can\'t ignore that side of it, I don\'t think.

MS. FOREMAN: I\'d like to go back to my original suggestion that we
build into the statement the primacy of having a public benefit. I have
suggested what technology transfer activities could be undertaken that
would be most likely assure the safest and most nutritious food supply
for the American people. There clearly, since all of this that we\'re
talking about is public money, it seems to me that the primary goal then
is, what is the biggest bang for the buck in terms of the public? And
that may be what\'s the project that\'s most likely to return a benefit
quickly, because the most work\'s been done, and the other side may be,
where is there an area where there is nothing that\'s going on and a big
need exists?

The dietary guidelines, another USDA activity, has as its, I think it\'s
number one suggestion now, increasing the amount of fruits and
vegetables consumed by the American people and whole grains.
Particularly useful to human nutrition and lacking in our diets is dark
green vegetables and those that are rich in carotenoids, the dark yellow
vegetables. Is there anything out there that makes those stay fresh
longer? Produces more of them so they\'d be less expensive? If you\'re a
food stamp recipient you can\'t buy fresh fruits and vegetables,
they\'re too expensive and they\'re rarely in inner city supermarkets.

I\'d like for us to have a presentation by somebody from either CSREES
or ARS about what the most pressing needs are for new specialty products
and let\'s, if they can\'t come from biotechnology, can they come from
somewhere else? I would just like to get this turned around. I was
really surprised to see that we talked about domestic markets, rural
communities, developing nations and didn\'t have any mention of what
specific mention of what will most benefit the people who are paying for
this. And I\'d like to get that back in.

MR. GIROUX: Just two comments. The first comment is, if I think I hear
what you\'re saying Carol is you want to, as I read that, the charge is
very narrow in scope, which was how do we bring biotechnology-derived
minor crops to the market, where I think what I hear you saying is,
should it be a discussion of whether we should use biotech or not?

And I really don\'t want us to get into that discussion of whether or
not there\'s other ways we should be bringing these crops \-- other
things that ARS, USDA should be using, what are the options? From what I
understand the charge is very narrow focused, and from what I saw from
Alan\'s presentation was in 1987 everybody was looking at biotech
applications, and somewhere between 1987 and 1997, major crops were able
to develop and commercialize and command large acreages of these crops,
but there was some aspects of the regulation, a lot of things probably,
that had an impact on the minor crops coming in.

There was this backlog of R&D, but no commercialization or acceptance,
and so when I look at this, I said, well we need to identify what are
the differences, why did, why was major crops successful and minor crops
not successful? What were the barriers or why didn\'t that happen? Which
ones does USDA have impact on, and where will we get the most bang for
the buck to bring whatever the best product is forward that is derived
from biotechnology?

MS. FOREMAN: Yeah, because I certainly wasn\'t trying to get into a
discussion of biotech, not biotech. You know, yesterday I brought the
surveys in and they showed that between 1997 and 2005 on specifically
biotech-derived products that we\'re talking about here, fresh fruits
and, or fruits and vegetables derived from biotechnology, and benefits
to me and my family from biotechnology. A substantially smaller
percentage of people think that those products will benefit them now
than thought so, or said they\'d buy them than said so in 1997.

I think that\'s because of the general distress and failure to have some
products that in fact delivered on that. It seems to me that if you have
products derived from biotechnology that have a direct benefit for
consumers, if I could have the tomato in January that tastes like the
tomato in July, I\'d probably think very differently about
biotechnology. But I would like for us, yeah, I really feel strongly
that we don\'t start from what do we do, I don\'t want to be driven by
biotechnology. I want to be driven by what\'s most likely to benefit the
American people.

MS. DILLEY: And I don\'t think your two points are mutually exclusive.
But this is an advisory committee on ag biotech, so we\'re looking at ag
biotech speciality, application for ag biotech to specialty crops, and
the criteria by which you would select those or whatever actions USDA
takes, is driven by that public benefit piece. Carol just added
nutrition and safest foods, most nutritious and safe foods supply for
the American public. I don\'t think that\'s in conflict at all with what
you\'re saying, Randy.

MR. GIROUX: It\'s absolutely not in conflict. I think that the consumer
piece, and exactly what you said is one of critical elements, but I
think there\'s likely several. I think we all have a perception of what
they are. I don\'t think we all understand what they are.

MS. DILLEY: Yeah, and that\'s probably part of the conversation that we
absolutely need to have. We\'re not going to decide that today, but that
is part of what is involved in taking on this charge. I would say that
even the conversation before we broke about Nick\'s point about isn\'t
lower cost food part of a public benefit? It\'s all part of that
discussion, as well as many other points that have been made.

And I would imagine some of the things in terms of what Duane raised for
the speakers in terms of, well how do you define that and who\'s having
a voice in that conversation? It\'s all part of what, I think, the
advisory committee can add to that, to USDA and present some perspective
on that. And it is specific biotech applications to specialty.

MR. GIROUX: What I was saying, what I was hoping Ms. Editor, I really
didn\'t say it right. Then even when very focused in what we want to
talk about \--

MS. DILLEY: I don\'t think you have any disagreement from this committee
on that.

MR. GIROUX: \-- and because we have so few meetings that, you know, we
need to with laser precision figure out what exactly we\'re going to
talk about and all of us have a common understanding of what we\'re
talking about, and then start talking about the topic.

MS. DILLEY: That\'s right. Yes. That\'s the interest I think we\'re
starting with fairly big, still fairly big circles in terms of trying to
get to laser like precision. We\'re not there yet, but we need to figure
out a way as to how to get there as quickly as possible.

MS. CRAMER: So I think that Carol actually articulated the point
beautifully. Which the real issue is, even in the New York Times article
that Carol brought in, there\'s all of these things that were promised,
why aren\'t they on the market, and that\'s exactly the issue. Is why
aren\'t they on the market, those things that were promised to bring
real benefit. And I think that\'s precisely the issue, is to see why
those things didn\'t come forward. What are the barriers? Are there
things that we can do?

MS. DILLEY: Mired within the context of specialty crops though, right?

MS. CRAMER: Yes. Within the context. And the other thing is that I would
like to insert in here that while we do need to be focused, public good
is broader than the nutrition and health and availability of the cost of
our food, which is that, this is, specialty crops are particularly
challenging because the specialty crop it grows in this region,
cranberries in wherever they grow, Maine, and you know, so there\'s
issues of when you talk about rural development and opportunity and who
participates. By definition, these are often regional, so it makes it
somewhat more challenging of how you put your overall federal dollars to
impact a relatively small region. So there\'s regional issues.

But we also need to look at the fact that sort of sliding in here are
going to be non-food specialty crops. That we talked about as far
merging in some of these other areas that clearly play into the non-food
as well. So I\'d like to both say, I think we\'ve made progress in
saying there\'s a real issue here, and the fact that we know there\'s
good things that aren\'t coming to the market. We need to as a committee
look at what those major barriers are but then what to be done to change
it, but then also the caution not to be just focused on who \--

MR. SCHECHTMAN: If I could just make one observation about the
differences that I heard in the two things. One, you said there\'s lots
of good things that aren\'t coming to market, and the other focus is,
you know, what are the things that are \--

MS. FOREMAN: Most needed.

MR. SCHECHTMAN: \-- most needed. And I think \--

MS. FOREMAN: And might be encouraged.

MR. SCHECHTMAN: And I think that\'s a bit of a, that\'s a tension that
\--

MS. FOREMAN: I agree.

MS. LAYTON: I wanted to go back and do a sort of charge to the committee
check on one basic item. Are we strictly going to limit this to genetic
engineering where we are introducing foreign DNA into a crop, whatever
we\'re talking about? Are we going to stay limited to transgenics in
this piece of our work or are we going to be somewhat broader into some
of the genomes, sequencing, marker-aided selection, that kind of piece
which is a little broader than we\'ve been, and I just wanted to double,
double check. That goes for both questions, I think. I want to make sure
whether we\'re staying in one piece or going broader to the broad term
of biotechnology?

MR. SCHECHTMAN: Well, I will answer that from the perspective of where
these questions came from, and that is genetic engineering.

MS. LAYTON: Transgenic, genetic engineering, we want to stay there?

MR. SCHECHTMAN: I don\'t want to distinguish between, you know, gene
whether you put the same genes back in through genetic engineering, you
know, whether that meets transgenic or not. But broadly speaking genetic
engineering.

UNIDENTIFIED MALE: What we\'re not talking about is marker-assisted
conventional breeding.

MR. SCHECHTMAN: Nor genomics.

MS. MELLON: Nor the protoplast fusion derived late blight-resistant
potato?

MR. SCHECHTMAN: Well, I wasn\'t quite sure whether that was protoplast
fusion to get a gene in and then there was some genetic engineering
following. I couldn\'t quite, I wasn\'t quite sure from \--

MS. DILLEY: Are you interested because of specifically the potato, that
example or?

MS. MELLON: No, I\'m just going to say that, I\'m using it as an
illustration of advanced technologies that are not necessarily genetic.
That are not transgenic.

MS. DILLEY: Would your potato example \--

MR. RADIN: Yes. Cell fusion like that is generally considered to be
genetic engineering in the minds of most people, and I believe it\'s
subject to the same rules as the insertion of foreign DNA.

MR. JAFFE: Yeah, I mean I guess, I mean USDA\'s role as we\'ve learned
on this committee is they\'re very broad roles. They have promoter
roles, they have regulatory roles, they have R&D roles, I mean, they do
all kinds, they have educational roles, they do all kinds of different
actions regarding agriculture, and the first couple of comments, Nick\'s
and others seem to suggest that part of the role of this, one way to
look at this issue is to look at, okay, well, but USDA is a research and
developer. We\'ve heard presentations about them funding research and
trying to get product development, and so one way you could look at this
charge is to look at, okay, how well is that money being spent and is it
really going, how can we work that end of it to get biotechnology,
biotechnology specialty crops out there that have an impact? And that
clearly is a narrow focus, and something that I think \--

MS. DILLEY: Focusing on R&D specifically.

MR. JAFFE: We could do, focusing on what is USDA doing and are they
doing it well and how could, I mean, how can they help bring these
products to market with the money they have, with the funding they have?
That kind of thing. A completely different way to go about it would be
sort of what, in terms of a barrier analysis or a bottleneck analysis
saying that there are others out there who have developed things and
also some may have come from the R&D money from the USDA, but why
aren\'t they getting to market? That to me is a much, much broader
analysis that really gets to the whole biotechnology debate.

I mean, and so I hesitate if we\'re going to do, go down that path, how
we\'re going to go do that because you get into IPR issues. You get into
legal issues. You get into consolidation issues. I mean I could argue
that the companies that have bought up, Seminis was just bought up by
Monsanto. They were one of the major developers here and now Monsanto
says, we\'re not going to do any genetic engineering in fruits and
vegetables.

I mean there are a host of, if we\'re going to get into broad consumer
acceptance issues and international issues, and Europe markets and
things like that. And then, we make, be able to figure out what some of
the barriers are, but then the actions that USDA can do become much more
tenuous. They\'re not as linked to some of those things. If there\'s
multinational corporation consolidation as one of the major reasons for
this, I\'m not sure what kinds of actions we\'d be able to pose to that.
So, but I think we need to think depending on which avenue and how much
we\'re going to go down these, one given our time constraints, and two
given, if it\'s, you know what things does USDA have control over or
ability to impact. They have a lot of ability to impact their own
research budgets and where they put money, and how they try to, to get
these products there. They may have very little ability to influence the
consolidation of the agricultural industry and buying of patents and
consolidation and things like that.

MS. FOREMAN: And our recommendations may actually have some impact on
how much money they get.

MR. JAFFE: Right. So to me, I mean, I think that, I haven\'t, I think
you could read this both ways. I am hesitant to go down that barrier
analysis, that other one, one because I think we\'re going to get into a
lot of regulatory stuff that Alan talked about, you know, are we going
to talk about, are we going to spend our time talking about other
special roadmaps for specialty crops within USDA\'s regulatory system or
should they be treated differently. I mean if those are the barriers, I
mean when we get into regulatory stuff \--

MS. DILLEY: So you want the R&D barrier because we can get our hands
around it in the time that we have.

MR. JAFFE: I think it\'s something that we should analyze and look at
and see if that fits in with things, and I think it\'s something that we
could have some very direct actions that might, that USDA could actually
implement. Some of these other things I think we\'re going to get into
very broad discussions about a lot of the issues that we raised in our
last report without us really having the expertise to know which of
those are really the true barriers. I mean, Alan brought up the issue,
real things and perceived things. I think we\'re going to get stuck on
those a lot.

MR. SCHECHTMAN: A couple of observations if I could. I don\'t think what
this question is asking is to say, we want you to push the plum but not
the rose. I don\'t think that, you know, it\'s saying, we think, you
know, we\'re going to go choose among ARS\' projects and do this one,
but not that one. I don\'t think, you know, this is, \-- USDA has roles
in rural communities, you know, at the farm level, in addition to the
research and development side of things, and USDA doesn\'t do that much
on the development side.

A lot of what USDA does is upstream and though there is variety
development in specialty crops because it\'s not done so much elsewhere,
USDA\'s biggest strengths are not in making products. They\'re in
getting, on the research side. They are in getting things to the point
where they can be taken over, and brought into the rest of the
agricultural system.

I don\'t think that the whole analysis of all of the roadblocks is
something that you could accomplish in the time that you have. But I
think at the same token, it\'s not just looking at USDA\'s research.
It\'s not the only place you could have an impact, because USDA has
impacts in other places. So it\'s a little bit of a hybrid of both, but
it\'s certainly not the big thing that you said. And maybe there\'s
going to need to be a little more discussion on it.

MS. DILLEY: Well I heard Greg say R&D which covers a bigger thing than
just R. I mean that includes tech transfer and there are other things.
If that was the major thrust of it, then that\'s potentially doable on
the merit that there are things outside of that, then we talk about it
in terms of committing others, saying, you know, do you absolutely have
to look at something else. But I think to try and narrow this, I think
that was really helpful in my mind, because I didn\'t see anybody, but I
saw a lot of heads nodding while you were talking. We want to have a
scope that\'s doable, R&D is much more doable than the whole barrier
analysis writ large.

MR. JAFFE: And I was never suggesting we should decide whether they made
a good choice of plum pox or things like that. But clearly we saw two
percent and four percent of their budgets going in genetic engineering.
And maybe there is data and analysis out there that say\'s you\'ve got
to, I mean, what\'s the percentage of things that you do in R that make
it to D, and if you\'re only putting very small amounts in, then maybe
their criteria are too narrow to get something out. I mean, out of the
pipeline. You may need to invest 50 percent of your resources in
something to get a product anyway. So I mean, looking at it in a much
broader scale, obviously not looking at specific products.

MS. DILLEY: We need at least a half an hour on the other topic, and
we\'re getting close to that point. So I want to take the cards that are
up, and may be that we need a transition on how do we try and really
bore down on getting an articulation on what we\'re trying to do, or how
do we set up a game plan to do that.

MR. SCHECHTMAN: I mean, I don\'t think we\'re going to have a work plan.
I think we\'re going to obviously need to have some work groups to work
on scope and to get things back out to the committee, and I\'m going to
presume we\'ll have a work group on each of the projects to help hone it
down to manageable things which we will try to get out to people for
comment long before the next meeting. If that makes sense.

MS. DILLEY: And I think that before we send out the proofs, before we do
that, after this meeting. We have to at least have some conversation
about the other topic as well for the same purpose.

MR. DYKES: I think before we have work groups we\'ve got to know what
we\'re going to work on. I agree wholeheartedly with what Greg said. I
don\'t think we can, if we\'re going to have this done in what, in a
year, four meetings basically. So if we look at what we can do in a
year, I think we\'ve got to narrow the focus, and I really think that
there is a combination of both points. And I would suggest that the,
based on what we have on number one, what is the role for USDA in the
research development and introduction of modern biotechnology
application to specialty crops? I think that for me is the question.
Then we can

add \--

MS. DILLEY: So we were talking about R&D. What\'s introduction? Tell me
what that involves?

MR. DYKES: Well, I think that gets into some of the questions Carol\'s
talking about. If we\'re going to tie it to the food pyramid, what are
the things that USDA consider when they\'re looking at the nutritional
wellbeing of the American citizens as relates to this areas? Which R&D
they\'re going to do? What are some of these issues? Maybe this
presentation we just had from the group, getting the other to try to
coordinate some of the activities through there.

I could foresee, if you look ahead to the second one, I could see the
second one being, I could see the broad topic I laid out with eight or
10, we can decide how many that is, if it\'s eight or if it\'s 15 or
whatever, different aspects of that that we want to look at\-- rural
communities, nutritional wellbeing, food pyramid, developing nations,
coexistence, use for non-food crops. To me the second one is, it
introduces new topics that I\'m not sure have any context. So we could
talk about what\'s the issue of coexistence relative to the introduction
of specialty crops, biotech specialty crops?

What\'s the role in biotech specialty crops that are non-food uses? Both
of these to me were pretty well open. Would incorporate the second one.
And I think we might could get that broad topic with some limited number
of subset points covered in a year.

MS. FOREMAN: May I go out of turn, please, because I just want to add to
that particular point, because I think Michael\'s taken a very good step
in a positive direction.

It seems to me that we should, in fact, address in part barriers. I
don\'t think it ought to be an approach that\'s regulatory in focus, but
as Greg said, there are, what\'s getting in the way of development, as
well as in the way of research? And that Andrew Pollock article
mentioned some of these barriers that are really harder to deal with
than anybody has figured up to this point. So I think we can, without
focusing just on regulation, we can talk about why isn\'t that tomato
out there yet? Surely somebody can make it.

MS. DILLEY: Okay. So key piece is Michael that the actions more
specifically defined to research development and introduction?
Biotechnology applications to specialty products. And those are the \--

MR. DYKES: And they\'re all USDA\'s in the first part.

MS. DILLEY: Right.

MR. DYKES: So they\'re all USDA. Those three subsets on biotech and
specialty crops.

MS. DILLEY: And then the eight or 10. And this would be something that
maybe a working group could take a run at. What are those categories of
things that we need to look at?

MR. DYKES: Maybe one of them is barriers. Maybe one is education. One of
them is ensuring nutritional enhancements. Coexistence.

MS. FOREMAN: Money.

MR. DYKES: Resources.

MS. DILLEY: Let\'s try and take other cards and then we\'ll figure out
what next step. One would be helpful to have reaction to that because I
think we\'re starting to try and narrow in on a scope, and that will be
helpful.

MR. POLANSKY: I\'m comfortable in the direction that I sense we\'re
heading. The one point that I wanted to try to make is that to bifurcate
nutrition and safe products from economics, I don\'t think is possible
because what Carol mentioned, you can have the safest and most
nutritious food or group of food, and if the production costs are such,
and the marketing costs are such that a large percentage of our
population can\'t afford to purchase them, it\'s really not all that
meaningful. So I think that needs to be a part of the discussion. Maybe
not the core of it, but it needs to be.

MS. DILLEY: No, I think how all these factors interconnect is part of
the discussion that we want to have, and certainly influence any kind of
recommendations that would come from the group.

MR. GRANT: Yes, I have a lot of questions and not that many answers.
I\'m really excited about this topic. The more I understand it, the more
exciting I become about it. You know, I personally produce mostly
specialty crops, and our frustration hasn\'t been the interest of
researchers to do the work. It\'s been the inability to see a pathway
forward that would allow the research even to get started. So I\'d push
back a little bit when we just focus on R&D. That typically tends to
just end up looking mostly on the R side, and very little focus gets
done on the D side.

MS. DILLEY: I think you\'ll get pulled by the I side, the introduction
piece. But that\'s, I mean I think you\'re raising a good point to make
sure it doesn\'t get just the research portion of it.

MR. GRANT: Right. And I think we\'ll really miss the mark if we simply
end up looking mostly at the research side. It talks about, you know,
the tech transfer. I think that\'s critical that that be incorporated,
and so when you start thinking in that direction, then it moves right to
what Greg was talking about as far as barrier analysis. I agree that\'d
be very difficult, and I might suggest as a way to get there, if it\'s
the same concept as Carol was talking about, but a little different
framing. And that would be to perhaps do a case study setup where we
would look at an imaginary product, an improvement to existing product,
etcetera, as a part \--

MS. DILLEY: As part of an analysis, Duane?

MR. GRANT: Right.

MS. DILLEY: You would use case studies to do that?

MR. GRANT: As a frame work to build the analysis on. Because I think we
have to follow it all the way through from the lab all the way out, or
we\'ll miss, we won\'t have the continuity to actually answer this
question. I wanted to touch on a couple of other things. Positive
impacts in my mind, I may use a word that\'s getting some baggage, so
this is the word without the baggage.

In my mind it\'s sustainability of our domestic markets to be supplied
by domestic producers, and then by extension that is our, the
sustainability of our rural communities. I don\'t know how many of you
know the extent at which specialty crops have been losing out to
competitors from outside the U.S. There\'s been a real erosion of the
ability of U.S. suppliers to supply the U.S. market. And so in my mind
that\'s what the positive impacts are is the sustainability of U.S.
suppliers to supply the domestic market.

I think there is some parallelisms between domestic, or specialty
markets and developing nations. The parallelisms are that there\'s not
the ability to generate significant investment in the technology, and
then there\'s not the ability to cover the investment. There\'s not a
clear pathway forward. So if developing nations get pulled in, that\'s
about the only way that I can see to do it, is just to kind of highlight
the parallelisms between the two.

MR. KALAITZANDONAKES: I just wanted to raise an issue that Carol
initiated, and that is one of dealing not just about how do you maximize
public benefits, but the issues around distribution of benefits. Carol
said well, certain of the products are very regional, so therefore you
start looking at creating benefits, but benefits being basically
accruing only in small areas. The same argument can be made for
producers. Same argument can be made about consumers if you have large
benefits created for raspberries at \$3.50 per little box versus a
product that is being consumed by a much larger segment of the
consumers. That obviously, the distribution is very different.

Dealing with how we maximize public benefits is going to be difficult
all by itself. Dealing with distributional issues, in my view, would be
impossible to do in the context of a discussion like this. And so I\'m
not really sure that it would be a very easy one to tackle. But at least
at the minimum we should talk about it. Whether it\'s part of the
discussion or not.

MS. DILLEY: Maybe it\'s not a driver, but it\'s a consideration, and
it\'s in the comment category.

MR. KALAITZANDONAKES: Or how do we want to deal with it?

MS. MELLON: I guess I just want to argue. I agree that we should focus
on transgenics in this discussion. But I also think that we need to have
some context within which to focus on transgenics. And that that context
has to include the fact that we already have in our possession a much
more powerful technology which really has delivered enormous benefits in
terms of surplus quantities of food of enormous variety, safe,
affordable, for us and for the rest of the world. So this is a
technology that, the transgenic technology is an add-on to a very
powerful and successful technology that is already in place.

And I think that that context is important. It doesn\'t mean that we
shouldn\'t go forward, but it is a different context then if we didn\'t
have enough food, as we say didn\'t in the \'30s. We didn\'t have
affordable food and the technologies that were available were going to
give us something that met basic, you know, human needs. Here the basic
human needs have been met many, many times over, and what we\'re talking
about are development, economic opportunity issues, all of which I think
are big. But I just don\'t want, I want some context around the
discussion of what kinds of goods we can get from this new technology
and how we ought to spend our public dollars.

MS. DILLEY: Okay, so we need to pull this to a close. Carol very briefly
because we\'ve got to talk about the other topic.

MS. FOREMAN: I\'d just like to see what\'s at the bottom of the screen
because I can\'t. And because some how or another the, I don\'t see
anything up there that says we\'re going to talk about people who are
supposed to eat the food.

MS. DILLEY: Will be the American public.

MS. FOREMAN: Where?

MS. DILLEY: Right there. What is the role of USDA in R&D for
introduction of biotech specialty crops.

MS. FOREMAN: Okay. Thank you. I knew Michael had said it, but I had lost
it.

MS. DILLEY: Yeah, it\'s there. We don\'t have a perfect statement up
there, obviously. But I think we\'ve got a good feel for pieces of what
we\'re trying to do. We\'ve said what\'s in and what\'s, and what\'s
kind of on the periphery that we need to consider.

MS. FOREMAN: I knew it had been said, I just couldn\'t find it. Thank
you.

MS. DILLEY: Okay. So I think, to me, because we do need to spend 20
minutes on the coexistence topic. I mean at least now I feel, I don\'t
know if you do, but I feel like I can at least envision the kinds of
conversations we need to have and how to go forward in putting together
a plan. What we need then is probably a group or if some of you would
volunteer to help us turn some stuff around to present back to the
committee for additional discussion, and we\'ve got a general concept of
modern biotechnology application to specialty products and USDA\'s role
in R&D and I, research, development and introduction.

And what we need is a group to start thinking about taking all of the
information from the discussion, what are some of the things that we
need to, that we want to explore to be able to come together on, it\'s
more in those issues, and making some recommendations around this topic
and putting a game plan, work plan together to do that.

So I mean, I think we got some material to work with. It would be
helpful to know those of you who are particularly interested in this
topic as opposed to the other topic, because if you don\'t volunteer for
this one, you\'ll probably be volunteered for the next one. To help us
pull this together and put something out to the committee. So can I just
get a brief, a quick show of hands of the people who would be
particularly willing to help us out in shaping this one? Because we need
some work obviously in between now and the next plenary section. So
Steve, Duane, Carol, Brad. Anybody else? Carole Cremer.

Everybody gets to talk about everything. We just need some help in
between meetings to help us on our agenda and organizing stuff.

MR. SCHECHTMAN: And again, everything that happens in work groups is
stuff that\'s, to remind everyone, brought back to the full committee
for discussion. No decisions get taken at work groups.

MR. DYKES: I\'d like to ask a question. If we\'re going to do this in a
year and we\'re going to have only three or four more meetings, the
second one to me is even more jumbled than the first one. No offense to
you Michael. I mean it introduces specialty crops, but then it
introduces a whole new topic, which is a big topic of coexistence
relative to non-food uses of specialty crops. I\'m not sure why we want
to go through that, and so I would go further to add, I could envision
that we have one topic which we\'ve got pieces of, a start to, and we
can have a number of items that could be discussed relative to that,
that could include some of the stuff out of number two, i.e.,
coexistence of specialty groups for non-food uses and quality
enhancements.

I see two, pieces of two as a subset to one, so that there\'s one
coherent report that makes more sense to the Secretary.

MS. DILLEY: So that\'s a good transition into the next topic. And so
you\'ve got a, it\'s a good way of linking those. I think I would go
back to the same question that we started in the previous conversation
with in terms of the expectation from the Secretary. Michael, if you
have any additional insight in terms of envisioning a report from a year
from now.

You didn\'t ask for recommendations on this one, though if we link them
obviously that\'s, we could do that. But the first run at this yesterday
it sounded more like the issue spotting kind of approach that Greg had,
mentioned yesterday in terms of just you want to add the highlights of
what the committee\'s thinking about coexistence. But we need to put
some more parameters around that to really understand what would be
useful to the Secretary and what scope, and how we\'re approaching it.

MR. SCHECHTMAN: I mean I think in discussions that I had with several
members talking about the coexistence topic, and I\'m still struggling
with the idea of whether this is, whether this can be made into one
topic or whether they are two distinct things. The ability to do the
other topic is in part going to depend on what the scope of the
discussion is about. This is to be future oriented, but there obviously,
in some discussion with some members I heard a point that well, there
are some crops that could be talked about under here that some people on
the committee don\'t think should even exist.

Non-food uses in food crops, at least certain kinds of those are
problematic with some members on the committee. That\'s a challenge to
be overcome. On the other hand, we\'ve heard that energy crops are
likely coming, and they\'re coming probably on a fairly large scale.
Which may or may not be a specialty crop.

So I mean, I think that the committee is going to have to do a little
bit of work talking about, you know, what makes the scope of that both
important to discuss and discussable, and manageable to deal with. And
if indeed the committee could not, just because of the views on the
committee be able to tackle, be able to come to a description without,
you know starting from basic disagreements about PMPs, there\'s a good
argument to say let\'s not include PMPs in that discussion. Certainly if
we\'re talking about a one year project.

MS. CRAMER: What does the Secretary want on this? I mean, you\'ve been
involved in discussions somewhere. I mean, is that the question he\'s
interested in having addressed is how do we make these non-food uses
compatible with food and protect it? Or is he saying coexistence in a
much broader way?

MR. SCHECHTMAN: I don\'t think this was really very explicitly spelled
out. But I think, I mean I think the picture is, you know, in a world
where, the world is getting more complicated, more and more products are
getting out there. You know, when we have a fuller range of things that
are out there and a product is being contemplated or a product is
actually going to be used out there, there are going to be a whole lot
of considerations that are going to go into, a whole lot of coexistence
considerations that are going to go into most, considering whether it\'s
going to get out there, as well as what\'s going to happen in terms of
management decisions of the product. What are some of those things in
that more complicated world?

MS. VANEENENNAAM: I just had a question on the sentence. Is it only
enhanced crops of specialty crops, or is that a separate group? In other
words, so it\'s specialty crops for either non-food uses and \--

MR. SCHECHTMAN: Actually it wasn\'t. They should have been reversed for
clarity. Quality enhanced crops.

MS. VANEENENNAAM: Of any nature?

MR. SCHECHTMAN: Yes.

MS. FOREMAN: Because I didn\'t know we were doing any PMPs in specialty
crops.

MR. SCHECHTMAN: Yes.

MS. LAYTON: But I don\'t know, is it a commodity?

MS. FOREMAN: It doesn\'t, you know, since we had been using the
definition of specialty that was in the specialty crop law, I couldn\'t,
I didn\'t know anybody was proposing non-food uses for those.

MR. SCHECHTMAN: That\'s not where it should go. It should be "and use of
quality enhanced crops and specialty crops for non-food uses," is the
way that should have read.

MS. DILLEY: So when you say, quality enhanced crops, that can be in food
or non-food crops. When you say specialty non-food uses in specialty
crops, that\'s still also food and that. That\'s a really big universe.

MR. DYKES: Are quality enhanced crops here limited

to quality enhanced specialty crops, or is it quality enhanced all
crops?

MR. SCHECHTMAN: It\'s quality enhanced \-- I mean I think, okay. The
intent of it was quality enhanced crops \--

MS. FOREMAN: For non-food uses.

MS. DILLEY: What\'s the driver? Is the driver non-food uses or is it
specialty crops?

MR. GRANT: No, I think the, in my mind the driver is maintaining the
integrity of any special class of crop.

MS. DILLEY: No, it\'s coexistence. I mean the coexistence is the driver,
but we\'ve got other pieces that we need to get our hands around,
coexistence among what? I mean it\'s transgenic crops, but which is it?

MR. GRANT: No, it\'s, so it could be transgenic \--

MS. DILLEY: Crops within a broader marketplace I know. But don\'t we
have to put our hands around which ones?

MR. SCHECHTMAN: Yeah, I mean, I think in part, this is being made a
little bit more complicated. When you\'re talking about the coexistence
issues that these new kinds of crops are going to face, they\'re going
to face, regardless of whether you call them the subject or the object,
they\'re going to face the issues of coexistence with everything else
that\'s out there.

MR. GRANT: And the fact that they have to face coexistence isn\'t
changed if they\'re a specialty crop or non-food use, or if they\'re a
quality enhanced crop. It\'s not necessarily a specialty crop. It\'s
maintaining integrity of whatever the speciality is as it coexists with
other crops.

MS. DILLEY: Well, you know, as Adrian raised some of the ways people
were defining coexistence, so that goes to your point Duane in terms of
it\'s fair and open access to markets and producer choice in terms of
what crops you want to grow, and consumers choice of what they want to
eat, and it\'s that whole range of things regardless of what the
specific product is, and so, doesn\'t it still make, don\'t you still
have to kind of figure out the universe within that to be able to
advance that conversation? It\'s kind of a competition.

MR. GRANT: It\'s already spawned in my mind, no you don\'t. You should
be able to come up with a listing of criteria that could be applied
across the board \--

MS. DILLEY: For fair and open competition kind of things and then what
USDA\'s role \--

MR. GRANT: Right. That would be a more \--

MS. DILLEY: Asking for recommendations, we\'re just trying to lay out
the landscape of issues.

MR. GRANT: It would definitely be a more detailed list. Then I\'ll shut
up. It\'ll be a more detailed listing of criteria then exists currently
for the coexistence of different grades or classes of conventional
crops.

MR. DYKES: This is to me, as I listen to the conversations versus what I
read. This should be, what are the effects of marketplace issues? These
aren\'t coexistence issues. I think it\'s, in my mind, this is not the
proper use of the term coexistence as it is today. You\'re going what
are all the marketplace issues, I hear.

MS. DILLEY: To use some of the presentations from yesterday as an
economic issue, the marketplace issue is higher than the issues on
coexistence, aren\'t? I\'m not tracking.

MR. DYKES: Well I think coexistence to me is one subset of a broad group
of marketplace issues. And as I read this, as I listen to conversation
what you\'re asking for is what are the effects on the marketplace
issues on the development and use of again, quality enhanced crops.

If we\'re going to go back to all crops here, not just specialty crops,
but all crops, I think that to me is a whole other introduction of a
whole other concept, and then we got specialty crops for non-food uses,
which brings me back to, I think that a lot of this fits in as a subset
of the first one, because we\'re talking about the marketplace issue of
specialty crops for non-food uses. And then we\'ve got, how do we deal
with quality enhanced crops written large.

I think the focus is on coexistence for specialty crops for non-food
uses as it\'s in today\'s context. I don\'t think that\'s where we\'re
heading. I think that should be because of marketplace.

MR. KALAITZANDONAKES: If I look at the question, in my mind, we should
take out quality enhanced crops and specialty crops for non-food uses
and just leave the word crops, because I can basically \--

MS. DILLEY: So it just ends up crops?

MR. SHURDUT: Exactly.

MR. KALAITZANDONAKES: Because really, I mean can use five different
examples and they would all have exactly the same issue, whether it\'s
PMPs, whether it\'s organics, or whether it\'s quality enhanced crops or
whether it\'s biotech traits designated to go overseas. So I think the
confusion starts at that last section of the sentence because the issue
is not qualified by those crops.

MS. DILLEY: You had a lot of nodding heads.

MR. SHURDUT: Yeah basically, what was catching me up is either you got
to get rid of coexistence because even PMPs don\'t fit into the
traditional definition of coexistence. To me that\'s separate. They
shouldn\'t coexist in many respects. Either get rid of that word or you
make crops more generic. So that helps resolve it.

MR. JAFFE: Yeah, I know it was agree on that. I mean, also, specialty
crops are non-food uses, I\'m trying to think of what is, we didn\'t
talk about that in a variety in the next 5 to 10 years, so why are we
sitting here worried about coexistent issues for something that in our
other report said isn\'t even a possibility in the next 5 to 10 years.
That people are going to use tomatoes to make, you know, pharmaceuticals
or use lettuce to make a vaccine. I mean, the reality is, is
coexistence, this is a big issue and when I asked Bernice this in
several meetings before, she said it was broad and it talked about what
are the, I mean, the coexistence issues aren\'t different. They may have
some different degrees or some different kinds of \-- they\'re actually
integrity issues that are different for how to keep things separate. But
the coexistent issues I think are very much the same. So I just think we
should be looking at, you know, what are the effects of coexistence
issues on the development of crops today, and the future generation of
crops. Whatever those future generations are. Whether they\'re quality
enhanced. Whether they\'re specialty crops or not. I think otherwise,
\--

MS. LAYTON: But it\'s coexistence around the issue of genetically
engineered crops.

MR. JAFFE: Right.

MS. LAYTON: So can we say that, is it okay to say genetically engineered
crops?

MR. JAFFE: Of course.

MR. SCHECHTMAN: I mean, I think the one piece that I was trying to add,
that we were trying to add in this was the idea that this isn\'t
strictly looking at this today, but recognize that you want to be
looking at this at a point where they may all be the same issues, but
the world, but it is at a more complicated point where there\'s, you
know, a lot more, an increased number of those other kinds of products
that will be out there. But the issues may be very well be the same.

MS. LAYTON: Are you asking us to go back to scenario planning and look
at, for example, our rosy future scenario and say what\'s the
coexistence issue there?

MR. SCHECHTMAN: No.

MR. JAFFE: No, but in those three scenarios, we touched on this issue of
coexistence, not necessarily meaning to.

MS. DILLEY: And we should go back and look. Using or not using those.

MS. CRAMER: So I agree, and I think that part of where that\'s pointed
to is that they ask what\'s the effect in terms of planning decisions,
markets and rural community, which basically seems to me, they\'re
saying, what\'s the cost, who bears the cost and how do we manage the
cost of liability, the impact of, not now but when we\'ve got 50 of
these products that a community might be growing, how do we protect
them? How do we follow them? How do we ensure integrity and is this
going to be a bigger picture.

MS. DILLEY: We\'re getting close to something we can sink out teeth
into.

MS. FOREMAN: I was trying to do a little wordsmithing there and you got
to me too quickly. But it seems that we could say what are the likely
near term issues that may arise with regard to planning markets, rural
communities, arising from coexistence genetically engineered crops.

MS. DILLEY: I don\'t understand where near term came from when we\'re
talking about more future.

MS. FOREMAN: Well, I was just trying to get it from today up, I was
going back to the 5 to 10 years that we used.

(Discussion off the record.)

MS. FOREMAN: Then I think we can play with that a little bit to make
sure that we get your future \--

MR. SCHECHTMAN: Yes.

MR. DYKES: Are we going to be able to do both of these in four meetings?

MS. LAYTON: Well which one has higher priority?

MR. DYKES: I personally don\'t think we\'re going to do both of these in
three meetings. I think we\'re going to find ourselves just where we
have found ourselves on other topics. We\'ll be a year on each one of
these. We\'ll be three meetings on each one of these. So I think that\'s
another fundamental place for the committee is some discussion about do
you think it\'s possible to do it? Or do we want to try to limit it to
one? Or how do we want to go about it? Because I would put out that my
position, I don\'t think we can do both of these in a year.

MS. LAYTON: Is there a sense among the committee that it\'s not possible
to do both in a year?

MR. GRANT: I would offer, I think it\'s going to be very difficult to do
both at the same time, in my mind. I think we\'d be better served to
focus hard on one and push it through.

MS. FOREMAN: It looks to me like it\'s coexistence versus specialty
crops.

MS. LAYTON: Not do it in parallel. You\'ve got to do it in sequence not
parallel?

MR. GRANT: Yes. Right. I would rather do it in sequence and I would
rather do the first one first. In my mind that will inform a lot of
discussion on the second one.

MR. SCHECHTMAN: The first being \--

MR. GRANT: The specialty crops.

MR. SCHECHTMAN: I regret having not reversed the topics on the sheet
head that was done. Let me just respond to that. At one point I had the
sense from the Secretary\'s office that the priority was slightly the
other way around, but I can certainly go and revisit that, and probably
when we have the topics written, worked on. I think after this meeting,
regardless of the order that we do this, we need to go and set two work
groups up to get clarified versions of the topics, and to talk about the
elements of what needs to be done.

MS. DILLEY: Maybe the way we need to do this is having two groups really
tease out the different tasks and say to the Secretary\'s office, to
you, say this is our understanding of our charge and we think, you know,
we\'d like to do what you need, and so if they do have a priority among
them, otherwise we would choose. So maybe that\'s a conversation we need
to have with the Secretary\'s office.

MR. SCHECHTMAN: But I also need to be sensitive to the fact that we
indicated at one point that we were going to in a year be able to move
on to some work on transgenic animals. And I want to, you know, whether
we have a longer time frame on one of the projects and we do that
simultaneously with the project on transgenic animals. I don\'t know
exactly how it\'s going to make sense to that, but that was something
that we \--

MS. DILLEY: And that\'s supposed to be completed in six months.

MR. SCHECHTMAN: \-- that we indicated that we were going to do.

MR. KALAITZANDONAKES: I just want to say two words. First of all,
reacting to Michael\'s point, I think the coexistence issue is a lot
more complicated and putting years on it, I think it\'s a lot more
complicated and so putting it together with another topic, I would find
it to be difficult all by itself in a year, let alone with something,
another topic.

And secondly, in the context of the statements, I find the first one,
what are the effects of coexistence issues on development and use of
crops. Certainly a lot more confined. When I look at the second
statement, what are the likely issues with regard to planting, marketing
and so on, that opens the issues even broader than the coexistence. So
to me, going even further than that would make it even more impossible
to deal with. So I would like us to leave with some degree of
understanding on that issue itself.

MS. DILLEY: So the parameters are more clear \--

MR. KALAITZANDONAKES: Exactly. Before we go to working groups to tease
out the details of the scope, you know, just deciding what the scope is
in that context.

MR. SCHECHTMAN: Yeah, I mean, I take your point. I don\'t know that we
have time actually to do that now though. We can have some more
discussions via emails and, you know, the working group is going to have
to do some work on coming up to what is a manageable scope within the
bounds of what we\'ve talked about here. I take your point and we\'ve
never even had a meeting that\'s two and a half days before. So we\'ve
extended this quite a bit at this point.

MR. JAFFE: I\'m one of the people who\'s been on this committee for
three years since it began and we have now three reports to show for it,
and I\'m quite proud of those reports. They were big long reports. And I
guess one of my questions that I asked yesterday was, what is expected
on these topics related to it, and so I\'m not so keen to sort of say we
can\'t do these in one year, because I\'d like to lower the expectation
of what we\'re going to do related to them instead. I mean, I think, my
personal view is writing a 20 or 30 page report on committees is not a
very good use of all of our time. It takes a long time. And if we\'re
going to write, people have written hundreds of pages reports on
coexistence.

If we\'re going to even write a 20 or 30 page report on coexistence,
we\'ll spend two or three meetings just editing the report like we\'ve
done this last one in trying to get consensus language. Let alone the
knowledge that we have to learn to get to that stage. I don\'t even
think we can do one of these in a year if that\'s our goal. I\'d like to
see these more being brainstorming at issue spotting things, and the
coexistence thing is maybe you have some speakers in on a couple of
different things. Do some brainstorming.

You know, write a five page report that does some issue spotting, that
raises some issues and maybe you have some different kind of thinking.
Like the scenarios thing did, and what\'s already out there. Because
there is a huge body of information on coexistence, and I don\'t think
we, the value we add in this committee is that we have the whole range
of the food chain and different interests here, and so we can bring some
different perspectives to it. We\'re not experts on the details of
coexistence. We\'re, you know, and on these topics. So to me, I\'d like
to see us not think in terms of 20, 30 page reports that really
comprehensively address an issue like we did with global traceability
and labeling.

But more issue spotting, brainstorming and putting down some key
thoughts that aren\'t at all comprehensive in that sense. But that do
raise some new issues and bring some things to people\'s attention. And
then maybe we go further into one or two of those issues in a more
detailed fashion over the next year or something like that. But so to
me, I agree with Michael and others that these are, if we\'re thinking
in terms of the way we\'ve done these last reports, they are impossible
to do in three or four meetings.

If we\'re thinking in terms of some brainstorming, some issue spotting,
bringing in some experts, thinking about things, and thinking about
project perspectives and then trying to just articulate some of those
different perspectives in very short succinct kinds of reports or even
oral discussions or whatever, we do have oral transcripts from this. I
mean, I don\'t know whether we need to even have formalized reports if
we can have oral transcript with summaries or outlines of issues and
things like that, then maybe we can accomplish a significant amount on
these two things in that year\'s time.

MR. SCHECHTMAN: I can assure you that the Secretary will not read the
transcript.

MR. JAFFE: I understand that.

MR. SCHECHTMAN: I mean, I agree with you completely that, I mean, I
think, I saw my head nodding when you were saying that. We are looking
for short succinct things, and it\'s not attempting to, you know, cover
an issue in detail in the way that traceability and labeling report was
done.

MS. DILLEY: Okay, I think that\'s right and we\'ve gotten maybe some
more clarification on the recommendation request. It needs a little bit
more understanding in terms of expectations from the Secretary. Because
coexistence, I think, was issue spotting, and the other one was
requested for recommendation, so if that\'s not the case, we, I think
it\'s awfully hard to have the expectation of recommendations with a one
page, you know, five page paper. So that\'s another part of figuring out
scope and how long it\'s going to take the group to come complete its
charge.

MS. FOREMAN: Actually, I see this as we\'re going to talk about
specialty crops or coexistence, or try to do both. The labeling and
traceability report addressed coexistence in some parts. The one that we
just finished addresses coexistence in some parts. Do we have anything
else that\'s new and creative to say about coexistence? If we follow
Greg\'s notion of having some speakers come in and do five pages of
these are the likely issues. I think that probably is as far as we can
do on that.

I don\'t know if it\'s, I can\'t remember, was coexistence raised in the
scenarios document too?

MR. DYKES: I think it was.

MS. LAYTON: I think it\'s in there.

MS. FOREMAN: Have we got more productive to say about coexistence in a
short period of time?

MS. DILLEY: So in short, you\'re going for the specialty crafts?

MS. FOREMAN: I think so, only because, you know, we might do coexistence
if we could pledge ourselves to do a very short paper of these are the
things that are likely to pop up and not try to say how we think they
should be resolved.

MR. GIROUX: I\'d like to echo what Greg said around what the work
product could be. I think we should even lower our expectations even
below that. I think three meetings, four meetings, we\'d be lucky to
finish a five page report on one of the two topics then try to do both.
And I\'d rather, my preference is we would do one well than try to do
two fast.

From my perspective, I have to disagree. I think, and I\'d be, while I
understand the importance of us resolving the issues around specialty
crops, I don\'t think we have in any of the reports we\'ve written,
expressed all of the issues under any useful recommendation, not even
recommendations, statements for the Secretary on what\'s going on in
coexistence. It touches on the AP issues. It touches on coexistence. But
I don\'t think in any of the reports that we put that into some concise
version of what is the dynamic and inner dynamics of those things that
are going on.

I think with all of the issues going on and the huge discussions going
on in Europe around coexistence, I think we would be remiss not to at
least have our Secretary understand what is going on in the USA, what
are our beliefs from the USA? They may or may not be the same as what\'s
going on in Europe. And so, my recommendation is we work on one. I\'d
have to support the coexistence one because from my industry\'s
perspective, it is a critical issue for us.

MR. DYKES: I\'m where Greg is if we\'re going to do a 20, 30 page
report. However, I think we\'ve got to, in order to do a four or five
page report, which I\'m fine on, we\'ve got to have some discussion
about how, what\'s that, how\'s that going to be organized? Or
otherwise, we will keep expounding on each of the things we raise which
is how, I don\'t think we started with any of the others that we\'re
going to end up with 20 pages.

We expound on that. Well, if we\'re going to say that, we\'ve got to
talk about this. If we\'re going to talk about this, we\'ve got to talk
about that. And then we end up there. So I\'m fine with, and I agree
that a 20 pager as we had on T and L and some of those things are going
to be difficult to do in four meetings. But if we\'re going to say well
we\'ll do it, and we\'ll do it in four meetings, then it\'ll only be
five pages.

I think we\'ve got to have some more structure and organization around.
So how are we going to assure we get it maintained to that? And then the
piece about animals. You had said something about we\'re going to get
into animals. And I don\'t want to get us into another discussion, but
are you going to add other people to committee or it\'s going to be a
whole new committee, because I\'m not sure that we\'ve got the expertise
around the table to get into the animal issue or the interest.

MR. SCHECHTMAN: That is a separate question. There\'s going to be
another opportunity for members to come on the committee. So, I mean, I
think as we indicated last time, there is a reasonably expectation
there\'s going to be some turnover when we have to move to animal
topics. If we\'re working on two topics at once it complicates things,
of course.

MR. DYKES: And you may have some people that are on the committee now
that if the topic is going to switch to animals, may wish to no longer
be on the committee.

MR. SCHECHTMAN: Yes. I\'ve just been informed that the room is needed.
We were booked here until noon.

MS. DILLEY: Can we take the last cards off and then, I mean, I think all
we need is still a consult to get through of some sort. Let\'s not call
it a working group for the other one, but we need, we still need some
more conversation. We\'ve obviously run out of our time, but we need
members willing to help us put some more definition around both charges
and then figure out how we develop a work plan that sets appropriate
expectations.

MS. FOREMAN: Could we ask the Secretary which of the two he\'d prefer?

MR. SCHECHTMAN: My intent was to go back and inquire of the Secretary\'s
office, once we have a little, once the consultative groups have worked
on each topic, each of the two topics, I will go back and I will say,
and I will inquire as to where they would most like the input.

MR. GRANT: Very quickly. It\'s process. I completely agree with everyone
who spoke who has said we\'d like to get it done quickly and limit it to
five pages. I would just offer that if we hope to do that, we will have
to have some, a different process by which we work. If I\'ve read
anything in the last three years, is that how an issue is described
because it\'s very important to people as the description starts to
limit what the potential solution might be. And so we\'ll have to have a
different way to process our reports if we hope to get them done.

MR. SCHECHTMAN: Okay. Other processes I\'ll just say require commitment
from everyone to be able to work on things in timely fashions and we
need to be able to work as efficiently as a whole committee can.

MS. DILLEY: Yeah, and in combination with what you said, Duane, I think
more creativity around what the product is and really the value of the
conversation and placement more maybe on that as opposed to, \-- we just
need to figure all that stuff out and it goes to your point of how the
committee conducts its work.

MR. GRANT: There are some other ways to work.

MS. HUNT: Just very quickly really. Not having been on the committee
that long, I see a huge challenge in working consecutively on both of
these topics at the same time. And if you\'re looking for me for a
choice on which \-- the coexistence one.

MS. DILLEY: Can we get some people who would be willing just like we did
for the other topic to help us be, consult with us on coexistence? So
all of you know, just remember, leave this right next to this.

(Whereupon, at 12:15 p.m., the meeting was adjourned.)

Digitally signed by Keena Lukacinsky

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United States Department of Agriculture:

ADVISORY COMMITTEE ON BIOTECHNOLOGY AND 21ST CENTURY

AGRICULTURE

12th PLENARY SESSION

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Keena Lukacinsky, Transcriber