The Fit Between Organic and Pharma Crops in North Carolina

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The Fit Between Organic and Pharma Crops in North Carolina

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Claire G. Williams, Nature Biotechnology
-

25, 166
-

167 (2007) ; Department of Biology, Box 90338,
Duke University, Durham, North Carolina 27708 USA. claire.williams.at.duke.edu


To the editor:

A news feature by Jeffrey Fox in the October issue (Nat. Biotechnol. 24, 1191

1193, 2006) highlights
progress in molecular pharming (or farming), the practice of growing plant
-
made pharmaceuticals (PMPs)
and industrial proteins (PMIPs) using genetically mo
dified (GM) plants. In certain US states, molecular
pharming is being touted as a solution to an ailing local agricultural sector. Indeed, some growers are
drawn by a simple fallacy: if Monsanto's (St. Louis, MO, USA) Roundup Ready GM soybeans are a
profit
able product, then GM crops making PMPs or PMIPs must be as good or even better. But field
-
grown PMP or PMIP crops are not food products and provide no panacea for the ailing agricultural sector.
By contrast, liability and steep capital outlay pose a steep

barrier to entry for the average grower. I
illustrate this below using North Carolina as a case in point.


North Carolina has arrived at a critical juncture, caught between its agrarian heritage and a progressive
investment in biotech. Even so, sustaining

the local food supply for North Carolina is becoming a central
issue for consumers

and voters. The state's population will increase to 12 million people in less than 20
years, a challenge that few agrarian states must confront 1. Demand has already outstr
ipped the local
food supply. In 2005, North Carolina became a net food importer for the first time 2, which means
increased reliance on rising fuel costs. Nationally, the average food item now travels 1,596 miles from
producer to consumer 3. The rising int
erest in local food production can be traced not just to rising fuel
prices but practical necessity. In recent years, the state's citizens frequently experienced catastrophic
weather events ranging from prolonged ice storms to the occasional hurricane, whi
ch constricted
transportation, fuel and food.


At the same time, the capacity for local food production is declining. Similar to many other states, the
average North Carolina farmer is 56 years old 4. The average farm in North Carolina is only 168 acres,
n
etting a modest annual income of $28,000 4. Major sources of farm revenue are now livestock and
animal feed crops, displacing tobacco 4. With tobacco
-
buyout programs in full swing, many farmers are
experimenting with new specialty products. One specialty i
s organic farming, the fastest growing segment
in North Carolina agriculture. Organic farming has a focus on direct sale of local foods, although
eventually it will develop regional or national distribution systems. Organic farmers in North Carolina, of
wh
ich only 73 are certified, are making premium returns. Those that are certified pay for a quality
-
control
process in which the food is routinely tested for the presence of GM DNA. The larger question is profits
--
and prices
--
from local food production, whic
h is a problem not only for organic farmers and buyers but
also, more broadly, for all local small
-
scale producers and consumers.


Local growers are also considering a far more controversial specialty, molecular pharming. The story of
Ventria Biosciences (
Sacramento, CA, USA;


http://www.ventriabio.com/)) illustrates its appeal to
independent growers in eastern North Carolina. Ventria is testing two industrial proteins already in use as
dietary supplements, lysozyme and lactoferrin. After several unsuccessf
ul attempts in other states ]5,
Ventria secured US Department of Agriculture (USDA)
-
Animal and Plant Health Inspection Service
permits for North Carolina for the years 2005 and 2006, and contracted with independent growers in
coastal North Carolina. Last y
ear's planting was 335 acres of rice (Oryza sativa) transgenic for lactoferrin
or lysozyme.


Scaling up such PMIP crops presents these growers with several challenges. First is the problem of
containment in this hurricane
-
prone riparian ecosystem. In the V
entria case, this is a minor objection
because rice is a self
-
fertilizing plant, which minimizes the possibility of pollen escape. Still, concerns
have been voiced about long
-
distance dispersal of PMIP rice pollen via hurricane
-
speed winds and about
consum
ption of PMIP rice by birds and other wildlife.


Second, compliance guidelines for PMP and PMIP crops require a steep investment in new equipment
and infrastructure. It is not clear whether North Carolina growers other than those with a large land base
and

deep pockets will be able to make the necessary capital outlay to produce these products. US
regulators now require each grower to set aside special farmland, farm equipment and separate areas for
cleaning and processing PMIP crops. Costly employee traini
ng is also required as part of compliance with
new US Food and Drug Administration and USDA regulatory statues for molecular pharming ]6. At this
early
-
stage PMIP market, Ventria covers all costs for the North Carolina contract growers. In the future,
howe
ver, independent growers will be expected to provide a seed
-
to
-
harvest package deal for the firm's
recombinant protein product. Only the larger, wealthy growers in North Carolina will profit.


The third issue, liability, is the most critical. Who is liable

in the event of a food or feed mixup with PMP or
PMIP crops? The unanswered question of liability blocks entry even more than capital outlay. And liability
risk will be highest where GM food plants are grown side by side with PMP and PMIP crops.


With the
se caveats in mind, field
-
grown PMP crops by independent growers in North Carolina (or other
agrarian
-
based US states) is not a practical solution for drug firms either. These firms place a premium on
uniformity and purity of recombinant proteins. Field
-
gr
own PMP crops require more complex processing,
produce uneven protein quality and yields and are more likely to include residues from herbicides,
pesticides and fungicides. Non
-
food crops grown in containment systems provide a better solution for
PMP produ
ction.


Such systems have been built around higher plants, such as duckweed (Lemna spp.) 7 and tobacco
(Nicotiana spp.) 8,


9, or algae (Chlamydomonas reinhardtii) or moss (Physcomitrella patens). In the case
of duckweed, the containment system allows unli
mited scale
-
up, efficient product purification/processing
and no residues from pesticides. Proteins exuded via roots of genetically modified plants are harvested
from the container's aqueous media also offer some advantages over processing green tissues. I
ndeed,
North Carolina already has a competitive edge in producing PMPs through the use of duckweed, tobacco
and other non
-
food plants safely cultivated in containment systems 7, 10,


11.


Perhaps Ventria's field
-
grown PMIP tests in North Carolina are a str
ay outlier and not indicative of a larger
trend towards non
-
local molecular pharming field operations positioned to contract with independent
North Carolina growers. True, growers in North Carolina badly need new markets but molecular pharming
based on foo
d crops in open fields is not the answer.


We should strongly consider legislative support for biotech firms developing containment systems. This
would be especially important for PMIP products, as well as PMP products, because the former are less
valuable

and more sensitive to cost
-
of
-
goods arguments, with the impetus on field
-
grown systems rather
than containment. Such support would attract private sector investment while protecting small growers
and consumers. By doing so, legislators will have found the

fit between PMP production and local food
suppliers.


For densely populated states like North Carolina, politicians, scientists and growers alike must live,
work

and eat

within the same narrow geographic coordinates. The citizens in these states may rely
on
a globalized food transport system, but grocery prices will favor local food production as prices soar with
rising fuel costs. And rising fuel costs

not just catastrophic weather events

will favor local food
production and organic farming. Those pursuin
g field
-
grown molecular pharming will likely find
themselves up against an increasingly vocal group of opponents

not only activists, but also independent
growers and consumers

with the following mantra: "not in my backyard."


1. US Census Bureau, Populatio
n Division, Interim State Projections, 2005. [ http://www.census.gov
-
population
-
projections
-
34pyrmdnc2.pdf/



2. Hamrick, D., oral presentation at "Finding the Fit Between Molecular Farming and Organic Farming
Opportunities for North Carolina," roundtable
discussion at Duke University, Durham, NC, April 3, 2006. [


http://kenan.ethics.duke.edu/PDF/Roundtable
-
Final.pdf

3. Pirog, R., Van Pelt, T., Enshayan, K. & Cook, E. Food, Fuel and Freeways. Report for the Leopold
Center, Iowa State University (Leopold C
enter, Ames, Iowa, 2001).
http://www.leopold.iastate.edu/pubs/staff/ppp/food_mil.pdf

4. USDA National Agricultural Statistics Services.


http://www.nass.usda.gov/QuickStats/PullData_US.jsp.

5. Fox, J.L. Nat. Biotechnol. 23, 636 (2005).



6. Stewart, P.A.

& Knight, A.J. Technology Forecasting and Social Change 72, 521

534 (2005).

7.Gasdaska, J.R., Spencer, D. & Dickey, L. Bioprocessing J. 2, 49

56 (2003).

8. Somerville, C.R. & Bonetta, D. Plant Physiol. 125, 168

171 (2001).

9. Poirier, Y., Dennis, D.E., K
lomparens, K. & Somerville, C. Science 256, 520

523 (1992).



10. Streatfield, S.J. Expert Rev. Vaccines 4, 591

601 (2005).



11. Fischer, R., Stoger, E., Schillberg, S., Christou, P. & Twyman, R.M. Curr. Opin. Plant Biol. 7, 152

158
(2004).

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2.Res
ponse to The fit between organic and pharma crops in North Carolina

-

Nature Biotechnology
-

25, 167 (2007)


Nature Biotechnology responds:


Although industry organizations, such as the Biotechnology Industry Organization (BIO), continue to
support food cr
ops for PMP and PMIP expression systems, we hold to our original view that they pose too
many problems and nonfood crops are a better alternative (Nat. Biotechnol. 22, 133, 2004).


In relation to Williams' concern over litigation, in our view, neighboring

certified (e.g., GM free) organic
growers in particular represent a litigation risk for farmers who elect to grow PMP/PMIP food crops in
close proximity. Even if certified organic growers are comparatively scarce
--
only 73 organic growers are
certified in
North Carolina
--
their livelihood and certification status are under threat from PMP/PMIP crop
admixture/introgression/hybridization events and thus they are likely to be especially vigilant for such
events, more willing to file suit to protect their busine
ss interests and serve as rallying points for
opposition.