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Checkbiotech: A public consultation on plant molecular farming
Posted by: DR. RAUPP ; madora (IP Logged)
Date: June 11, 2005 08:00AM

www.czu.cz ; www.usab-tm.ro ; www.raupp.info

Plant molecular farming (PMF) is another phase in the ongoing research and
development of transgenic plants, offering possibilities of producing
therapeutic and industrial proteins. However, this technology poses
important social and policy challenges. A public consultation was held in
four regions in Canada using a modified focus group approach. Respondents
received a background document on the technology prior to discussions. Five
specific applications were discussed to investigate views on food versus
nonfood crops, medical versus industrial applications, and containment
approaches. Public assessments were on a case-by-case basis but were also
clearly based on balancing benefits and risks as well as considerations of
environmental impacts and regulatory oversight, June 2005 by Edna F.
Einsiedel and Jennifer Medlock.

Introduction

Plant molecular farming (PMF) is another phase in the ongoing research and
development of transgenic plants, offering possibilities of producing
therapeutic and industrial proteins. Molecular farming involves the use of
genetically enhanced plants to produce pharmaceuticals and industrial
products. The first pharmaceutical protein made in plants?in this case, the
tobacco plant?was human growth hormone. Since 1986, when this experiment was
publicized, other proteins have been produced, from experimental vaccines to
antibodies to industrial proteins.

At the same time, plant molecular farming raises social, environmental, and
regulatory challenges that need to be addressed when considering how these
products might be successfully and responsibly commercialized. Recent
changes to regulatory processes have taken place in response to concerns
about the efficacy of seed production and commodity handling systems,
environmental safety issues, and contamination of the food supply. In the
face of these concerns, calls have been made for ongoing risk assessment,
regulatory assessment and reform, greater transparency, and enhanced public
and stakeholder participation, with some arguing that "it is social support
for the technology and trust in regulatory institutions that matter most".

We began a major initiative to investigate various commercialization aspects
of PMF in late 2003. The purpose of this larger PMF project is to
investigate the policy and regulatory developments in this area and to
explore stakeholder views and perceptions...1 Although calls have been made
to assess public views on this issue, there is very little published
research in this area. One report in the United States focused only on the
use of tobacco as the PMF model crop, with data obtained via interviews by
phone, face-to-face, email, and small-group discussion with a range of
stakeholders (tobacco producers, policymakers, nongovernmental organizations
[NGOs], and agricultural biotechnology company representatives). Although
most were supportive of this technology (with the exception of those from
the NGO sector), concerns were expressed about environmental impacts and
regulatory capacity. The Canadian Biotechnology Secretariat (an arm of the
Canadian federal government) addressed PMF in its semiannual survey work on
biotechnology with two questions investigating yes/no support for two PMF
applications: the production of interleukin, an enzyme for health treatments
(80% supported this application), and the production of biodegradable
plastics (78% supported this application). No other study has been published
on public and stakeholder perceptions of PMF. By uniting medical,
industrial, and agricultural practices, PMF becomes a more complex
technology in its social aspects. Although publics have generally been more
supportive of "red" biotechnologies (i.e., medical applications) than
"green" biotechnologies (i.e., agricultural applications), this study
investigates how hybrid red-green technologies will be perceived and allows
for elucidation from participants on the reasons for their choices (beyond
the scope of the quantitative survey referenced above).

In 2004, we carried out a series of modified focus groups in four regions in
Canada, designed as an early-stage public consultation with lay Canadians on
PMF. There are many approaches to public consultation, from town hall
meetings to deliberative forums. In comparison to quantitative surveys,
focus groups are not designed to provide a representative picture of the
general population. Instead, focus groups allow more extended discussions
and uncover more detailed and nuanced explanations for people's positions.
Discussions were structured around awareness of PMF, identification of key
issues from the perspective of the layperson, reactions to specific PMF
applications (i.e., using food vs. nonfood crops and producing medical vs.
industrial products), and perceptions of various containment scenarios.
These consultations were intended to understand early-stage consumer
perceptions and policy preferences that could contribute to ongoing policy
development as well as provide a base for a larger-scale consumer study to
be carried out in 2005. Initiated at the behest of the Agriculture ministry,
this study was designed and carried out independently.

Methodology

Approach

The consultation process was designed by the authors, and focus group field
work was carried out by a commercial firm. Participants were recruited
randomly from the general population. Final selection was based on
fulfilling a set of demographic criteria so that the panel would be balanced
in terms of age, gender, education, and occupation. Because this
technological application was quite new, the traditional focus group
approach was modified in two ways: (a) by providing background information
to participants so the discussion to be undertaken would be based on some
understanding of the basics of PMF (discussed in detail below) and (b) by
providing more time for deliberation (each group was 2.5 hours in length).
The consultation process was conducted by a research company in Vancouver,
Toronto, Halifax, and Montreal between April 12-21, 2004. .2 Regional
representation is a critical dimension in Canada; these highly urban sites
are typically selected for this type of research.

Briefing Document

Each respondent was sent a discussion paper in advance of the meeting. The
paper was a 10-page document developed by the authors that provided an
explanation of the technology, some typical applications, a regulatory
overview, and a discussion of the benefits and risks involved with the
technology. To ensure scientific and factual validity, the document was
given to a PMF expert with extensive experience in the field. The briefing
document was then tested on volunteers from various education levels (from
less than high school education to university graduates) to ensure clarity,
understanding, and balance. The finished product was a detailed overview of
the technology in a question-and-answer format (e.g., "What are PMFs?" "Why
use plants?"). The objective of this discussion paper was to provide
background information on the topic of PMFs to encourage a more informed
discussion of the issues raised by the technology.

Procedure

During the recruitment process, volunteer participants were invited to read
the discussion paper and to bring with them to the focus groups three key
issue areas or concerns they had about PMF, and which they felt needed to be
addressed before decisions could be made about applications and research in
this area.

The facilitator first explored levels of awareness among the participants
prior to their having read the briefing document. This was followed by a
discussion of each participant's key issue areas?the questions and concerns
that participants considered important to address in the development of the
technology. A series of five PMF applications were then discussed in turn,
focusing on different products (industrial and pharmaceutical) and different
host crops (food and nonfood). Finally, responses to different containment
strategies were explored as well as perceptions of regulatory capacities.

PMF Applications

We selected applications of plant molecular farming that are currently in
(or within five years of) commercial production to be used in the focus
group discussion. Each application was described by the moderator, and the
participants were then invited to express their views on each one. The
applications are described below.

The enzyme trypsin, traditionally isolated from cow or pig pancreatic
sources and used in large volumes in the detergent and leather industries as
a catalyst, has been produced in genetically modified corn. It is thought to
be the first large-scale protein product from transgenic plant technology.
Tobacco plants have been genetically modified to produce interleukin, an
enzyme used in treatments for diseases such as Crohn's disease. This
application has been tested in field trials in Canada.
Transgenic potatoes have produced a vaccine against the Norwalk virus.
Norwalk virus capsid protein (NVCP) was used as a test antigen and was able
to trigger immune responses in healthy volunteers who ingested the
transgenic potatoes.
Gastric lipase, an enzyme used to treat cystic fibrosis, has been produced
using corn. This application is currently advancing through clinical trials.
Corn plants have been modified to produce bioplastics. Still in the
experimental stage, biodegradable molecules have been derived from modified
corn to produce bioplastics.

The discussion around these cases acted as a catalyst for deconstructing the
factors relating to how judgments are made about specific applications
(which have real-world implications) and to move beyond the initial
conversation about the topic in general (which tended to be more of a
theoretical discussion).

Acceptability Spectrum

After discussing the applications, participants rated each on a four-point
acceptability spectrum: fully acceptable, more acceptable, less acceptable,
and unacceptable. In addition, participants were asked to comment on each of
their ratings in writing. They were also asked to give a rating of and
comments on the technology of PMF as a whole.

Results

Awareness and Initial Reactions

Only two of the 48 participants had heard of the concept of PMF before being
contacted for the focus group; none were aware of any specific applications
of PMF. First impressions of the technology were mixed but leaned towards
the positive. As a concept, PMF is a field of research that was described by
most as being fascinating, promising, and exciting but also potentially very
risky. It was initially viewed as positive because of the perceived
potential for developing new treatments for diseases and/or cheaper and
simpler drugs. Most of the participants viewed plant-made pharmaceuticals as
a "cousin" of genetically modified (GM) foods under the general umbrella of
biotechnology, and, like its relative, viewed this application with some
trepidation.

Key Issue Areas

Respondents tabled a wide range of key issues and questions they considered
were important for decision makers to take into account, many of which
revolved around the following themes: The potential for cross-pollination
and contamination of food crops. This was the most dominant issue that was
raised. Many participants (particularly women) felt that contamination of
food crops could happen relatively easily. These concerns were fueled by
several underlying factors: First, participants thought that the modified
product would get into the food chain through direct cross-pollination, or
through wind, animals, insects, or birds. Many made direct reference to the
Monsanto v. Schmeiser case as evidence of this possibility.3 Some expressed
skepticism about the idea that the PMF versions of plants and crops or other
agricultural versions of plants would be separated entirely from each other.
Second, participants were concerned that humans might contaminate food crops
either by error (for example, by accidentally taking plant material from a
greenhouse and dropping it onto a field) or malicious intent (for example,
bioterrorism, or modifying a food crop to produce a toxic substance and
introducing that plant into the food supply). Third, participants thought
that the methods of disposal of waste material would not eliminate
sufficiently any chance of modified plants entering the ecosystem.

Common to these factors was the idea of some of these technologies "running
wild" and taking over food crops. A few mentioned evidence of this type of
event occurring with foreign species (zebra mussels and Asian ladybugs were
mentioned).

Issues of safety, regulations, and policing. Participants had concerns about
the ability of regulators to adequately monitor these technologies. There
was a fairly widespread perception that regulators were hampered by a lack
of resources or lack of sufficient expertise to appropriately oversee the
research to ensure that all safety measures were being fully met.
Participants also cited concerns about the scope of the existing rules and
regulations; some suggested that there might not be appropriate guidelines
and standards in place. However, the concern about adequate policing
capacity tended to be greater than the concern about insufficient
standards/regulations. For most, the issue was not about achieving zero
risk, but rather minimizing risk, ensuring transparency about regulatory
approaches, and factoring in uncertainties.

The potential long-term side effects, specifically impacts on human health
or the environment. These considerations were of significant concern,
particularly among those who expressed the strongest trepidation about the
technology at the outset of the discussion. Participants suggested that
these technologies might reveal impacts that will not be detectable for
years after they are introduced. The interests of those growing, farming, or
researching these applications not being consonant with the public interest.
There were a number of questions raised about the role of commercial
interests in developing these applications and the potential of the profit
motive to ultimately supersede the public interest in terms of safety. For
example, participants felt that even if the rules and regulations were
stringent, growers/farmers would not necessarily follow these rules
carefully. Similarly, the discussion showed little faith in companies having
concerns for the public interest as they develop these technologies.

Acceptability of PMF Applications

Overall, participants tended toward the middle two points on the
spectrum?either more acceptable or less acceptable than at the poles of
outright acceptability or unacceptability. The focus groups revealed that
most people held a mix of views on these applications and tended to lean
toward acceptability or unacceptability on a case-by-case basis, depending
on the purpose of the application and how they weighed the benefits and
risks involved. Below is a summary of the reactions to each of the
applications, followed by a broader discussion of how participants made
their judgements across applications.

Application 1: Interleukin in Tobacco

Some respondents suggested that this was an interesting and potentially
beneficial application, especially if interleukin were a relatively scarce
enzyme that might enable more people to have access to treatment. The idea
of using tobacco as the medium to produce interleukin (instead of corn) also
gave some people greater comfort about reducing potential food-crop
contamination risks and finding a socially beneficial use for tobacco.
However, uncertainty was also expressed about production costs and potential
risks, particularly possible contamination between tobacco and food crops

Application 2: Bioplastics in Corn

This application also generated a fairly clear split in opinion. Most people
found the principle behind this application to be compelling and appealing,
primarily because the idea that synthetic plastics could be reduced or
eliminated was seen to be an important step in reducing waste and pressure
on landfill sites. However, there were clearly and widely articulated
concerns about the contamination risks of growing these PMF crops in corn
plants. Participants were very concerned about the impact on health or the
environment if this type of application made its way into the food system.
Ultimately the environmental goals were not universally lauded, as several
people in each group suggested that taking a measure like this is like a
band-aid and that encouraging people to reduce waste was a more appropriate
step. As a result, for the majority, the benefits side of the equation was
not compelling enough to overcome concerns about the risks.

Application 3: Edible Vaccines

This was the most widely acceptable of the applications tested, for a number
of important reasons on both the benefit and risk sides of the ledger.
First, most saw it as an effective way to administer a vaccine, and
participants imagined that there would be demonstrable benefits to being
able to deliver vaccines in this form to developing countries in particular.
In that sense, the application was seen as providing a new benefit to health
treatment, over and above cost savings. However, cost savings was also seen
to be of particular benefit in this case in terms of being able to
distribute treatments in developing countries. The other compelling element
of this application was that it would or could be utilized as a preventative
measure as well as a treatment. The risks of contamination were viewed to be
significant on this application, but they tended not to weigh as heavily in
assessments. The idea that in some instances the product might be produced
in powder form was seen as posing less risk of contamination than utilizing
the product in its natural form. Thus, despite the fact that this
application involved a food crop, respondents appeared to weigh the benefits
from this application as being greater than the risks.

Application 4: Trypsin in Corn

Most participants did not view this as a beneficial application overall.
Rather, they tended to view the benefits as accruing mainly to companies in
the form of higher profits. Two respondents suggested that by introducing
lower cost inputs, consumers would benefit by lower prices, but this was not
a widely held view. Many others did not believe that money would be saved
because of all the safety measures that would be required to use the PMF
version of trypsin. Even if there were cost savings, there was skepticism
that consumers would actually benefit and that whatever cost savings might
be achieved would not be worth the risks. A number of people suggested that
because there were conventional alternatives, the benefits of going forward
with this application were not as great, especially when the risks were
taken into account. Overall, there were few reasons that were seen to
warrant engaging in research for this type of PMF technology.

Application 5: Gastric Lipase in Corn

This application generated mixed reviews. The drivers of acceptability
tended to revolve around a couple of factors. First among these was the
potential to treat the 15% of patients who do not have effective treatment
options?here, the principle of the application being "new" was compelling to
many people. The secondary driver of acceptability was the idea that this
treatment will be safer for patients?participants suggested that more proof
that treatment is truly safer would be required; if so, this would
contribute to acceptability. The factors contributing to unacceptability
again revolved around the idea of contamination of food crops and concerns
that the benefits would primarily be about cost savings for companies that
may not be passed on to consumers.

Determining Acceptability

The purpose (or benefit) of the application was the most important factor in
determining whether an application was acceptable. From their comments, it
was clear that participants tended to assign widely differing values to the
benefit factor, depending on the application involved. Health and medical
applications were consistently seen as being more acceptable than industrial
applications. This was arguably one of the most important areas of consensus
about PMF. Furthermore, if the purpose was seen to provide a significant
potential benefit to human health or the environment that was greater than
existing products or applications, people tended to be more supportive of
it, assigning a higher value to the application. In addition, if an
application was viewed as providing economic benefits (e.g., lower cost) but
not significant new benefits to human health (i.e., not a new treatment, but
a better way of producing an existing treatment), the weight that people
assigned to the perceived benefit was lower. If the benefits were entirely
economic (e.g., lower cost and an industrial product), the benefit value
people assigned to it was quite low.

In the discussions, the risk side of the equation tended to be relatively
constant (and relatively high) for all applications, whereas the benefit
side tended to vary significantly. In cases where the benefits were seen to
be substantial, they could overcome concerns about risk, but if the benefits
were viewed as minimal, the overall assessment tended to move towards the
less acceptable side of the spectrum. Our overall assessment is that people
tend to engage in a risk-benefit analysis about each application, assigning
weight to a number of factors associated with both benefits and risks.

In virtually every case, acceptability is predicated on the idea that there
are stringent approval processes and long-term measures in place to ensure
safety. This is essentially a quid pro quo for willingness to go forward
with any PMF application.

The perceived level of risk was the first factor that people employed when
considering acceptability. Risk of contamination and risk of impacts on
humans, the environment, or wildlife were the major elements that were
considered. The results showed that people tended to assign a level of risk
to PMF applications which were dependent on a number of factors.

If the PMF application is grown in a food crop, it was likely to be assigned
a higher level of risk than if grown in a nonfood crop. However, for some,
the risks with nonfood crops would not necessarily be mitigated, because
pollen dispersal could occur with insects or birds. When benefits were seen
to be much greater (i.e., benefiting large numbers who had little or no
alternatives), this modified the risk-benefit equation, as was the case with
edible vaccines.

If the PMF application is grown in an outdoor context, it was likely to be
assigned a higher level of risk than if it is grown in an indoor context.
There was general agreement that growing these products in enclosed settings
(such as greenhouses) would reduce the risks to a point where most
applications would be acceptable (again assuming that appropriate regulatory
provisions were in place).

If the PMF application retains properties of being able to seed or flower,
it was likely to be assigned a higher level of risk than if it is unable to
seed/flower. Flowing from the discussion of risks associated with food and
nonfood crops, people in a number of the groups discussed the prospect of
developing nonflowering versions of the plants that would be used for PMF.
The idea of producing nonflowering plants as PMF-designated plants was
appealing as a counter to contamination of food crops.

Conclusions and Policy Implications

This modified consultation yielded a number of important findings.
Participants weighed in thoughtfully on plant molecular farming and
discussed policy options; they also clearly articulated the nature of their
expectations and concerns.

Although initial awareness of the technology was very low prior to this
consultation, background information provided a sufficient basis for
informed discussion. The key concern most often identified by participants
was the potential for contamination of food crops (whether the product was
grown in a food or a nonfood crop). Other concerns included issues of
safety, regulation, adequate monitoring, and the possible long-term human
health and environmental side effects. Distinctions in risk determinations
were made in the following areas:

PMF products grown in food crops were seen as riskier than nonfood crops;
PMF products grown in the outdoors were perceived as riskier than those
grown indoors; and
if the plant host is able to go to seed or flower, it was seen as riskier.

These concerns weighed heavily in evaluating the various PMF applications.
However, it was the nature of the perceived benefits that ultimately
determined the level of acceptability of each application: Are the benefits
sufficient to warrant taking a substantial risk? The purpose of the product
being made via PMF was a major factor in answering this question. This
purpose test essentially responded to two questions: What is the application
for? Who is it going to benefit? Medical applications were preferred over
industrial applications, and within the industrial realm, producing
environmentally friendly products was preferred over the ability to produce
products at a lower cost. Although food crops were essentially rejected as a
production mechanism, edible vaccines proved to be an exception in this
case, with the benefit for developing countries seen as a positive
outweighing the perceived risk.

What these results suggest is that the conditions under which PMF is carried
out are important to public assessments of the technology, but in addition,
the nature of regulatory oversight is equally critical. Such conditions
could warrant greater confidence in the technology. Ultimately, the purpose
test was really a surrogate for assessing the benefits of an application,
which proved to be the most important arbiter of how respondents viewed the
specific applications that were discussed in the group. Indeed, in several
cases, this test trumped the various other risk considerations that were
tabled in the discussion.

For policy makers, these findings suggest that attention to a number of
areas is critical. First, the issues around impacts to human health and to
the environment, biosafety, and risk assessment and risk management
processes are clearly important for publics, in much the same way they
remain important challenges for those involved in research and production of
plant-made pharmaceuticals. The issue of potential contamination, from the
perspective of publics, also raises the importance of comprehensive
liability frameworks as a priority. Some countries with biosafety frameworks
have made clear that the entity marketing the GMO is solely liable for all
consequences. Second, the importance of access to information and
transparency in the regulatory process are going to be priorities for
publics. Our study demonstrated that publics who were consulted in this
initial stage had a very good grasp of important elements about this
technology to make considered judgments?judgments which were sufficiently
nuanced when participants were provided with a reasonable information base.

Finally, early considerations of full life-cycle dimensions of the
technology will be critical. These include upstream considerations of
choices of plant vehicles, downstream elements including cost-benefit
assessments, full risk-assessment plans that include disposal at the
production end, and post-market monitoring of impacts of plant-derived
pharmaceutical and industrial products.

Endnotes

1 This larger study is being carried out by the genomics, ethics, economic,
environmental, legal, and social studies project supported by the Genome
Canada program. This public consultation is part of this larger study and
was supported by funds from Agriculture and Agri-Food Canada and Genome
Canada. 2 There were 25 males and 23 females in the final sample; 14
respondents were under 35 years of age, 20 were between 35 and 54 years old,
and 14 were over 54 years old. The education distribution showed that 13 had
a high school degree or less, 17 had a college degree or some university,
and 18 were university graduates. 3 A Canadian farmer, Percy Schmeiser,
claimed that his field had been accidentally contaminated by Roundup Ready
canola from his neighbors' fields. The Canadian Supreme Court found
Schmeiser in violation of Monsanto's intellectual property. Monsanto Canada
Inc. v. Schmeiser. Supreme Court of Canada. Judgment of 21 May 2004. SCC 34.
2005 AgBioForum

[www.agbioforum.org]

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