Consumer/Household Economics, Food Consumption/Nutrition/Food Safety,

Einsiedel, Edna

Medlock, Jennifer

English

Research Papers in Economics

CHOICES
The magazine of food, farm, and resource issues
4th Quarter 2005 • 20(4) CHOICES 253
A publication of the
American Agricultural
Economics Association
4th Quarter 2005 • 20(4)
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Ag-Biotech: It’s Not Just What’s for Dinner 
Anymore, but the Future Contents of our 
Medicine Cabinets
by Jennifer Medlock and Edna Einsiedel
Forget about farm-to-fork when it comes to genetically
modified (GM) crops. Think farm-to-pharmacy, or farm-
to-factory. Produced through plant molecular farming
(PMF), this new set of transgenic crops is being grown not
for food, but to produce medicines and industrial prod-
ucts. For example, potatoes have been modified to pro-
duce a vaccine against the Norwalk virus, research that is
currently in human clinical trials to determine efficacy
(Tacket et al., 2000). On the industrial side, corn plants
have been modified to produce trypsin, an enzyme used in
the manufacturing process of insulin and vaccines, an
application already on the market in the United States
under the name TrypZeantm (www.prodigene.com).
GM food production and PMF differ in one very sig-
nificant way. In GM food, the product is the plant (to be
consumed by humans or animals). In PMF, the product is
the medical or industrial compound (the plant is not des-
tined for the food chain). For GM food, the idea is to
make crops easier to grow, for example through insect or
herbicide resistance, or to enhance a crop’s nutritional
value, as in vitamin A enriched “Golden Rice.” In PMF ,
the crop is used as a production vehicle or factory (Ma,
Drake, & Christou, 2003). It is the ultimate product, the
medical or industrial compound that is of interest, not the
plant itself, which is considered a waste product after the
compound is removed. PMF products can be grown in
both food crops and nonfood crops (corn and tobacco are
the most common platforms).
By uniting agricultural biotechnologies with medicinal
and industrial processes, PMF has already aroused contro-
versy. Those with a stake in this technology include con-
ventional farmers, PMF companies, food processors and
exporters, academic scientists, patient groups, policymak-
ers, as well as members of the general public. And just as
the number of stakeholders is large, so is the disparity in
opinion. Prodigene, an early industry player in PMF , has
this outlook for the technology on its website (www.prodi-
gene.com):
Imagine a day when taking children in for vacci-
nations will not involve a single tear being shed.
Imagine that, in the place of a shot, the doctor
gives your child a small bag of edible treats. This
bag of treats will not be any ordinary snack—it
will be an edible vaccine grown in corn and then
made into an appealing snack.  
Meanwhile, from the NGO perspective, a spokesper-
son from Friends of the Earth forecasts a very different
future, saying that with “just one mistake by a biotech
company, we’ll be eating other people’s prescription drugs
in our cornflakes” (www.foe.org). 
The diversity of stakeholders demonstrates the chal-
lenges for policy development around this emerging tech-
nology. In Canada, no commercial applications of PMF
have yet been approved. Policy is still in the early stages of
development, which provides a useful entry point for
stakeholder and public assessment of the technology to be
incorporated into policy development. Two studies con-
ducted by the Genome Prairie GE3LS (Genomics, Ethics,
Environment, Economics, Law, and Society) research
team, one on focus group discussions with the general
public (Einsiedel & Medlock, 2005) and one on stake-
holder interviews (Mistry, Einsiedel, Medlock, & Perra-
ton, 2005), will be discussed in this article (along with
their consequent policy implications), but first we will
provide context on the regulatory situation in Canada.
While the Canadian government conducts its policy
review (involving a number of departments including254 CHOICES 4th Quarter 2005 • 20(4)
Agriculture and Agri-Food Canada,
Health Canada, and Industry Can-
ada), the crops involved in PMF are
regulated under the authority of the
Canadian Food Inspection Agency
(CFIA). Plants used for plant molec-
ular farming are labelled as ‘plants
with novel traits’ or PNTs, and
broadly PNTs are defined as plants
that have had a specific trait added to
them through genetic engineering or
other methods. PNTs can be devel-
oped using conventional breeding or
through transgenic techniques. It is
the resulting product that defines it
as a PNT, and not the process of
development. 
The following appears on the
CFIA’s molecular farming web page:
“All PNTs in Canada are subject to
the same strict science-based regula-
tions. However, since PNTs for
molecular farming may present
greater potential for environmental
or human health risks, the Govern-
ment of Canada may put even more
stringent restrictions on the use of
these novel plants than for other
PNTs” (bold in original) (CFIA,
2005). 
In the meantime, the CFIA has
indicated that it is currently involved
in a broad policy review of plant
molecular farming. Until this consul-
tation and analysis are complete,
applications for confined research
field trials for PNTs intended for
plant molecular farming will be
addressed on a case-by-case basis.
The amendment lists a number of
“interim recommendations” for PMF
developers, the major one suggesting
that use of major food or feed crop
species for PMF is not recom-
mended. Other recommendations
include choosing host species that are
“as amenable to confinement as pos-
sible” and encouragement to consider
fibre crops, small-acreage specialty
food or feed crops, or new crops as
production platforms.
As policy development moves
beyond the bounds of the CFIA’s sci-
ence-based safety assessments, assess-
ments by stakeholder groups and the
public are integral to developing
socially sustainable policy.
Public Views
Focus groups were conducted in four
cities across Canada (Toronto, Hali-
fax, Vancouver and Montreal) (see
Einsiedel & Medlock, 2005).
Because of the unfamiliarity of PMF,
participants received a 10-page brief-
ing document in advance of the ses-
sion that outlined the technology, its
potential applications, and how it
might be treated by the Canadian
regulatory system. They were asked
to read the document and bring with
them three key questions and/or con-
cerns with regards to the develop-
ment of the technology. 
Not surprisingly, awareness of
PMF before being contacted for the
study was very low, with only two of
the 48 participants ever having heard
of the technology, but none knowing
of any specific applications. In con-
trast, participants revealed a high
level of awareness of GM food and
evaluated PMF within that reference,
calling PMF a “cousin” of GM food.
Focus group participants dis-
cussed their concerns around four
main themes: potential contamina-
tion of food crops; safety issues;
appropriate regulation; and, long-
term impacts.
The potential contamination of
food crops was the most dominant
issue raised. The main concern was
that the ‘modified’ product would get
into the food chain through direct
cross-pollination, animals, or wind.
As well, concern was raised that
humans might contaminate food
crops either by mistake (accidentally
moving plant material from a green-
house to a field) or by malicious
intent (for example, through bioter-
rorism). 
On the issues of safety and regu-
lation, while participants were willing
to accept a certain level of uncer-
tainty with PMF, they were also con-
cerned about the abilities of regula-
tors to adequately manage the
technology because resources to do so
were seen to be inadequate. Concern
was also expressed about the ade-
quacy of standards to monitor
longer-term impacts.
Concern over long-term side
effects for human health and the
environment was raised by those
respondents with the highest level of
trepidation about PMF. They won-
dered about whether enough time
had been or would be allowed to
effectively study these effects. Con-
cern about proper balancing of com-
mercial versus public interests was
also expressed. 
Ultimately, acceptance or rejec-
tion of PMF was dependent on the
perceived “purpose” of the applica-
tion. Whether a particular applica-
tion had a “useful” or worthwhile
purpose had a substantial influence
on participants’ perceptions. This
purpose dimension was explored in
more detail in the next stage of the
session, where reactions to five spe-
cific applications of PMF (that are
currently in or close to commercial
production) were elicited from par-
ticipants. The different applications
were chosen strategically to incorpo-
rate different streams of PMF work;
for example, are reactions different
for products made in food crops ver-
sus nonfood crops? Or for industrial
compounds versus medical com-
pounds? After discussing the applica-
tions, participants rated each of them
on a four-point “acceptability spec-4th Quarter 2005 • 20(4) CHOICES 255
trum” (Fully Acceptable, More
Acceptable, Less Acceptable, and
Unacceptable). The five applications
that were used in the discussion are: 
1. Trypsin in corn: Trypsin, a pro-
tein derived from corn, is used in
a variety of commercial applica-
tions including the processing of
some biopharmaceuticals;
2. Interleukin in tobacco: Interleu-
kin, a potential treatment for
Crohn’s disease, has been tested
in field trials in Canada using
tobacco as a platform; 
3. Norwalk virus vaccine in pota-
toes: Norwalk virus capsid pro-
tein (NVCP), used as a test
antigen, was able to trigger
immune responses in healthy vol-
unteers who ingested transgenic
potatoes;
4. Gastric lipase in corn: Gastric
lipase, used to treat cystic fibrosis,
has been produced using corn as
a production vehicle and is cur-
rently advancing through clinical
trials; and
5. Bioplastics in corn: Still in the
experimental stage, biodegradable
molecules are derived from corn
to produce bioplastics.
When judging the various appli-
cations, people assigned a higher level
of acceptability if the purpose was
seen to provide a significant benefit
to human health (Norwalk virus vac-
cine in potatoes and gastric lipase in
corn applications). If the purpose was
seen to provide economic benefits,
but not significant new benefits to
human health (i.e., a new way of pro-
ducing an existing treatment as in the
Interleukin example), then the appli-
cation was rated less highly. Finally, if
the benefits were perceived to be
entirely economic (i.e., lower cost
industrial products), the value
assigned was even lower. 
In general, while medical applica-
tions were consistently preferred over
industrial applications, members of
the public appear to judge PMF on a
case-by-case basis, assigning different
levels of acceptability depending on
context of the application. Distinc-
tions were made also between pro-
ducing compounds in food crops and
nonfood crops, with food crops
assigned a lower level of acceptability
overall, though a significant level of
risk was perceived in all applications. 
PMF Stakeholder Views
To complement the public focus
group work, the GE3LS team con-
ducted a set of surveys with other
groups with an interest in PMF
(farmers, academic and government
scientists, and representatives from
the food industry, PMF industry,
patient groups and social/environ-
mental groups) (see Mistry et al.,
2005). The specific objectives of this
w o r k  w e r e :  1 )  T o  o b t a i n  a  g e n e r a l
assessment of plant molecular farm-
ing in terms of risk, benefits, and
challenges; 2) To examine perceived
risk, benefit, and acceptability of four
PMF applications currently in devel-
opment; and 3) To elicit views on
how PMF should be regulated.
An interim report has been com-
pleted on this work. The applications
tested were similar to those in the
public focus groups (Interleukin in
tomato, bioplastics in plants, trypsin
in corn, and vaccine in tomato). An
interim report has been completed
on this work. In the study, there was
conditional acceptance of PMF
across all sectors, except for the social
and environment groups who did not
support going ahead with any appli-
cations. 
A major caveat for support of
PMF was the lack of a regulatory
framework. This gap was mentioned
by all sectors, but for different rea-
sons. From the industry perspective,
not having a regulatory framework
was seen as a threat to investment in
a burgeoning field. For social and
environmental groups, if PMF were
to proceed, a strong regulatory
framework needed to be in place to
control it. However, like members of
the public, this group had doubts
about the capacity of the government
to adequately monitor the industry. 
Also echoing the public groups,
both food and nonfood crops were
considered acceptable for PMF devel-
opment (again across all sectors
except for the social/environmental
groups who did not support any
applications), but there was a strong
preference for nonfood crops as there
was a sense of inevitability that con-
tamination would occur at some
point in the future (all sectors raised
the risk of contamination to the food
supply). A representative from the
PMF industry preferred nonfood
crops due to a perceptions issue, say-
ing that “if it happens once, the
industry is dead.”
Another finding common across
all sectors was support for regulation
on a case-by-case basis. There is a rec-
ognition that the vast variety of pro-
tein products that can be produced
from PMF should not be dealt with
using blanket regulation. How an
application should be regulated was
dependent on a combination of the
product (toxicity/stability, location of
accumulation), production platform
(i.e., food/non-food) and scale (how
many acres?). Preferences for contain-
ment/confinement strategies were
also application-specific, but gener-
ally followed a ‘better safe-than-sorry’
attitude where more containment is
better. 
Where the stakeholder groups
diverged from the public sample was
in the comparison between medical
and industrial applications. The
opinions of stakeholder interviewees
were more nuanced, and there was
cautious support of both as respon-256 CHOICES 4th Quarter 2005 • 20(4)
dents could see benefits and concerns
raised in both cases. For example,
concern was raised in the medical
arena regarding whether there would
be pharmacologically active drugs in
the plants or whether they would be
benign until purified and then com-
bined with other elements. In the
industrial arena, concerns were
voiced about the potentially large
acreages to be used to be profitable. 
The issue of public involvement
and public awareness was raised
many times in the stakeholder inter-
views. Those in the PMF industry
f e a r  t h e  “ d r u g s  i n  m y  c o r n f l a k e s ”
view will take hold. An agriculture
industry representative suggested that
“the biggest risk (of PMF) is public
perception of risk.” Overall, there
was general belief that public views
on this technology will ultimately
determine its future. 
However, how to respond to the
public perception issue differed
among sectors, and fell into general
spheres of thinking. Those in aca-
demia and the PMF and food indus-
tries felt that the public just needs
objective information — educate
them and they will understand and
they will accept. Those in the govern-
ment, social/environmental, and
agricultural industry sector felt that
yes, members of the public should
receive information, but should also
be engaged in discussion and their
voices need to be heard in shaping
policy.
Lessons from These Early 
Conversations
The importance of early understand-
ing of public and stakeholder views is
evident. This has been a major lesson
from the experiences of the GM food
debates. Public concerns revolve not
just over why products are being
made from a technology, but how
they are produced and introduced
into the marketplace. This involves
the accompanying regulatory frame-
work that can encourage confidence
in their introduction and use. 
Members of the public and stake-
holders are clearly making trade-offs
in their initial assessments. For mem-
bers of the public, these include con-
siderations of long-term impacts, not
just to human health, but also to the
environment. Expectations that regu-
latory systems similarly weigh differ-
ent considerations, from economic
and commercial gain to public inter-
est considerations, are also evident.
Members of the public, stakeholders,
and regulators clearly have much to
learn from each other.
For More Information
Canadian Food Inspection Agency 
(CFIA). (2005). Plant Molecular 
Farming. Available online: http://
www.inspection.gc.ca/english/sci/
biotech/reg/pmfamve.shtml 
(Accessed November 8, 2005).
Einsiedel, E.F., & Medlock, J.E. 
(2005). A public consultation on 
plant made pharmaceuticals. 
AgBioForum, 8(1).
Ma, J.K., Drake, P.M., & Christou, 
P. (October 2003). The produc-
tion of recombinant pharmaceu-
tical proteins in plants. Nature 
Reviews Genetics, 4, 794-805.
Mistry, J., Einsiedel, E., Medlock, J., 
& Perraton, K. (July 2005). 
Stakeholder and public views on 
plant molecular farming. Paper 
presented to the International 
Consortium of Agricultural Bio-
technology Research (ICABR), 
Ravello, Italy.
Tacket, C.O., Mason, H.S., Loson-
sky, G., Estes, M.K., Levine, 
M.M., & Arntzen, CJ. (July 
2000). Human immune 
responses to a novel norwalk 
virus vaccine delivered in trans-
genic potatoes. Journal of Infec-
tious Diseases, 182(1),302-305. 
Epub 2000 Jul 06.
Jennifer Medlock (jemedloc@ucal-
gary.ca) is a PhD student and Edna
Einsiedel is Professor, respectively,
Faculty of Communication and Cul-
ture, University of Calgary, Alberta,
Canada. Support for this study from
Genome Canada and Agriculture
and Agri-Food Canada is gratefully
acknowledged.

Ag-Biotech: It’s Not Just What’s for Dinner Anymore, but the Future Contents of our Medicine Cabinets

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