Trends affecting the next generation of (2)

Technological Forecasting & Social Change 72 (2005) 521 – 534

Trends affecting the next generation of U.S. agricultural
biotechnology: Politics, policy, and plant-made pharmaceuticals
Patrick A. Stewart a,*, Andrew J. Knight b

Department of Political Science, Masters of Public Administration Program, P.O. Box 1750, Arkansas State University,
State University, AR 72467, USA
Department of Criminology, Sociology and Geography, Arkansas State University, State University, AR 72467, USA
Received 7 December 2003; received in revised form 3 March 2004; accepted 4 March 2004

This paper analyzes the structure and history of regulatory policies in the United States, focusing on recent
regulatory changes due to the promise and threat posed by plant-made pharmaceuticals (PMPs). PMPs are the
latest advance in the genetic engineering of plants and promise to produce medicines inexpensively and abundantly
by using a range of different plants as factories to express active medicinal ingredients; however, PMPs may pose a
risk to the public’s health if they enter the food supply. How the benefits and risks of PMPs are addressed by the
respective government’s regulation and how this will affect what, if any, products make it to the marketplace and
their ultimate success are of great concern to many different parties, ranging from consumers and farmers to health

and food production industries. As a result, this paper addresses the history of agricultural biotechnology
regulatory policy since 1972, arguing that three distinct periods may be identified: (1) from 1972 to 1986 when the
new biotechnology was focused on scientific self-regulation in the laboratory; (2) from 1987 to 2002, as the
technology was being developed and widespread release of certain technologies became more common and was
not perceived as an environmental threat, regulations became increasingly laxer; and finally, (3) we argue that we
are entering a third phase with a series of controversies over regulatory infractions involving genetically
engineered (GE) plants and the potential threats posed by PMPs.
D 2004 Elsevier Inc. All rights reserved.
Keywords: Genetic engineering; Agricultural biotechnology; Regulation; Field releases; Plant made pharmaceuticals, PMPs;
Plant-made industrial products, PMIPs

* Corresponding author.
E-mail address: (P.A. Stewart).
0040-1625/$ - see front matter D 2004 Elsevier Inc. All rights reserved.


P.A. Stewart, A.J. Knight / Technological Forecasting & Social Change 72 (2005) 521–534

1. The next generation in U.S. agricultural biotechnology
While genetically engineered (GE) crops, such as Round-Up Ready soybean and Bacillus thuringiensis (Bt) corn and cotton, have become a pervasive part of agricultural production in the United
States over the past 7 years, their place in the market is by no means assured. International trade concerns
and recent crises played out in front of the public have the potential to not only stifle support for these
products, but also lead to their being discarded if they are perceived by producers and retailers as too
much of a risk. With many nations following the lead of Europe by not accepting goods derived from GE
plants into their markets, or demanding their labeling, consumers will not have an opportunity to
purchase these products, as these markets will remain closed. In countries that are willing to embrace
genetic engineering plants, like the United States, if consumers are unwilling to buy these products and
the public is unwilling to accept the risk of GE plants being grown, it is unlikely that GE crops will
survive as part of the agricultural system. Public opinion is often the key driver in regulatory change. As
a reaction to public perception of potential threats and not experienced events, the biotechnology
regulatory arena has experienced a good deal of change since 1986. Because of the lack of substantive
experience with health and/or environmental threats from the release of biotech products, federal
government agencies established an amalgam of existing regulations to respond to potential, but not
established, threats. These regulations use genetic engineering as the trigger and have undergone a series
of alterations, as more knowledge of the risks associated with the release of GE plants has been
accumulated, as well as in response to public reactions, or lack thereof, to perceived risks.
Likewise, change in the field testing of plant biotechnology has occurred since the regulatory regime
was put in place in 1986 and field releases began in 1987. Three different generations of alterations to

plants have been identified as likely taking place. First-generation biotechnologies alter the characteristics of plants so that they require less agricultural inputs such as herbicides, pesticides, and fertilizer as
well as other chemicals. Second-generation biotechnologies focus on improving product quality so the
plants are more nutritious, tastier, or stay fresh longer. Third-generation GE plants are ones in which cash
crops act as ‘‘factories’’, producing industrial goods, pharmaceuticals, and other products more
efficiently and cheaper than traditional approaches [1].
First-generation products, such as Round-Up Ready herbicide tolerant plants and Bt insecticidal
crops, are used extensively by farmers. While crops exhibiting product quality characteristics have been
given regulatory approval, the second-generation crops have yet to catch on in the marketplace. For
instance, Calgene’s Flavr Savr tomato, which was designed to have a longer shelf life and a better taste
than traditional tomatoes, appeared briefly in grocery stores but was eventually pulled from the shelves
due to marketing and transportation problems.
Finally, the third generation of GE crops includes plant-made pharmaceuticals (PMPs) and plant-made
industrial products (PMIPs). PMPs are designed to produce vaccines and antibodies for a wide range of
diseases like rabies, traveler’s diarrhea, cholera, hepatitis B, antibodies to fight cancer, and tooth decay,
and therapeutic proteins for cystic fibrosis, liver disease, and hemorrhages. PMIPs can be used for a
variety of industrial purposes, such as to accumulate heavy metals in the plant to clean up soil, perform
as biosensors for hazardous materials such as explosives found in landmines, produce enzymes and
epoxies for industrial uses and plastics to replace petroleum-based products, and to produce cosmetics
[2]. GE plants, however, have not been embraced by all segments of society, as criticism and controversy
have attended their production, particularly as issues surrounding environmental and health risks have

become publicized.

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This paper considers the future of new agricultural biotechnology applications, particularly thirdgeneration products such as PMPs and PMIPs, by analyzing the regulations that allow these products to
be field-released and marketed. This paper will first examine the regulatory history of new agricultural
biotechnology products by analyzing the events that led to the promulgation of regulations and whether
the events led to more stringent or relaxed regulations. Next, the paper will consider trends in the new
agricultural biotechnology development by analyzing the U.S. Department of Agriculture (USDA)
Animal and Plant Health Inspection System’s databases. Specifically, we analyze trends in field releases
considering the types of plants that are being genetically engineered and the types of interventions being
considered. We conclude by considering the future of the new agricultural biotechnology applications in
light of trends in regulation, field experimentation, and politics.

2. Regulatory change and prevailing sentiment
The regulation of agricultural biotechnology can be seen as having been sequestered in a fairly well
insulated policy subsystem, with little public involvement due most likely to its highly technical nature.
As a result, there was little need for institutional intervention by Congress, the Executive Branch, or the

Judicial Branch [3]. More recently, forces within the policy subsystem have led to the relaxation of
regulations through the promise of new products and dearth of experienced difficulties in the field
experiments. However, recent focusing events, such as the GE corn’s effects on the monarch butterfly,
GE animal feed entering the United State’s food supply, and a plant pharmaceutical nearly entering the
food supply, have publicized and politicized agricultural biotechnology and the regulatory arena, leading
to greater scrutiny by more parties and stricter regulations [4].
When looking at the regulatory history of new agricultural biotechnology applications since 1972, a
pattern seems to emerge, with three different identifiable periods. The first time period can be considered
to start with the impetus to self-regulate by the scientific community, beginning with the Asilomar
Conference Center and ending with formal government regulation of field releases, with the promulgation of the Coordinated Framework by the Executive Branch’s Office of Science and Technology
Policy (OSTP). The second time period extended from the Coordinated Framework until recently, with
the widespread release of the new products of agricultural biotechnology in the fields, especially Bt corn
and cotton, and Round-Up Ready soybean. This period is marked by a deregulatory trend, as regulations
concerning the field release of GE plants were progressively relaxed. The third time period, the one into
which we are currently entering, marks a return to scientific concern and regulatory restriction, as a
series of events have called into question the safety of GE crops. These events have spurred a systematic
questioning of the regulation of GE plants in general, and PMPs and PMIPs specifically.
2.1. In the lab: Asilomar (1972) to Coordinated Framework (1986)
The impetus for regulation of the new biotechnology came not from an experienced catastrophe or
crisis, but from public concerns about potential environmental disaster. Well-meaning, but politically

inexperienced, scientists called for self-regulation to address public concerns they inadvertently kindled.
Specifically, in 1974, a meeting called for by a group of eminent scientists in one of the most visible and
important journals in the scientific world (Science) was attended by 150 carefully selected participants at
the Asilomar Center in Pacific Grove, CA [5]. This meeting, which was held to calm public concerns


P.A. Stewart, A.J. Knight / Technological Forecasting & Social Change 72 (2005) 521–534

over the use of recombinant DNA technology, instead highlighted the uncertainty of elite scientists and
their desire to restrict debate to within the scientific community by limiting public involvement and press
coverage [6,7]. While the result, scientific self-regulation with restraints only enforced on Federally
funded projects [specifically, by the National Institutes of Health (NIH)], was as intended, the Asilomar
conference and the events attending it served to set in motion a risk-averse perspective in which the
threat of the new biotechnology was assumed before it was proved. This in turn led to it being the first
technology to be regulated before risk was shown to exist ([8,9] p.223).
Over the next decade, most research tended to be laboratory-based. However, as the new
biotechnology started moving from the lab to the field, concerns over field releases of GE organisms
were raised, especially by such interest groups as the Foundation on Economic Trends (FET). One GE
organism in particular raised concern—a soil bacterium genetically altered to reduce the likelihood of

frost damage by lowering the point at which ice forms on a plant, in turn preventing an estimated US$1
billion in losses annually. Unfortunately dubbed ‘‘ice-minus’’, the perceived threat of the bacterium
escaping, proliferating, and altering the environment was used as a focusing event to draw attention to
the potential dangers raised by the new biotechnology, especially as the FET brought suit against the
Environmental Protection Agency (EPA) for not protecting the environment against this threat.
This, combined with the need to clarify administrative turf who had regulatory primacy over the
nascent industry and broader environmental concerns, led to the Reagan Administration’s OSTP
proposing the Coordinated Framework for the Regulation of Biotechnology (hereafter the Coordinated
Framework) in 1985, and its being promulgated in 1986 ([6] p. 192–197). The resultant Coordinated
Framework coordinated the regulatory jurisdictions of the Food and Drug Administration (FDA), NIH,
EPA, USDA, and the National Science Foundation (NSF). In all cases, a ‘‘pragmatic’’ approach was
used in which preexisting regulations were utilized on a product-by-product basis, but with the use of
genetic engineering processes to set off the regulatory trigger ([10] p. 79). The Coordinated Framework
put in place dealt with jurisdictional overlap between the USDA, EPA, and FDA1 with GE plant
products as they move from the field to consumers.
The first line of regulatory oversight with the field release of GE organisms was and remains the
USDA’s Animal and Plant Health Inspection Service (APHIS), primarily through the Plant Quarantine
Act (PQA) and the Federal Plant Pest Act (FPPA), although USDA also claims oversight through the
Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), the Virus, Serum,
Toxin, and Analogous Products Act (VSTA), and the Federal Seed Act (FSA). The EPA’s regulatory

oversight comes into play when products reach the commercial stage of development through the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act
(TSCA). Finally, FDA regulates the new biotechnology under the Federal Food, Drug and Cosmetic Act
(FFDCA) and the Food Quality Protection Act (FQPA), which also affects EPA to a lesser extent.
2.2. In the fields: Coordinated Framework (1987) to widespread field release (2002)
As previously stated, the initial point where GE organisms are regulated is by the USDA as field
releases, or the movement of GE organisms into or through the United States, under 7 CFR part 340 of
the FPPA and the PQA. Under these acts, APHIS asserts broad regulatory authority over organisms,
products, and articles that are plant pests or could harbor plant pests, whether they are genetically

Until relatively recently, FDA has regulated GE plants as substantially equivalent.

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engineered or not. Although the Coordinated Framework explicitly states federal agencies should focus
on characteristics of risk posed by the product, APHIS uses genetic engineering to trigger regulatory
oversight. With the permitting process, which was established in 1987 to allow for field testing of GE

plants, the process applies to organisms using genetic materials from organisms defined as plant pests,
unknown or unclassified organisms, or organisms that the APHIS deputy administrator determines to be
or has reason to believe is a plant pest [11].
These regulations, however, are not encompassing of all GE plants. While the use of recombinant
DNA inserted through Agrobacterium is a trigger for regulation, recombinant DNA inserted through a
gene gun, genes inserted that do not come from a listed plant pest, or a plant whose pest status is
undetermined do not trigger the same regulations. Although creators of such plants have, to date, sent
courtesy notifications or permit applications ([12,13] p. 107), there is no certainty that this practice will
In March 1993, the permitting process was changed by APHIS to include a notification track in order
to simplify the process. Six plant species, corn, cotton, potato, soybean, tobacco, and tomato, which were
considered genetically well characterized, and in which the transmission of GE characteristics were seen
as limited due to the lack of wild relatives in North America, were given notification status. The
reduction of paperwork through the use of the notification track, instead of the permitting procedure, led
to a decrease in the average waiting period from 120 to 30 days, and costs from US$5000 to US$250
dollars. As can be expected, there was a sudden upturn in field release activity, especially regarding these
crops (see Fig. 1).
In May 1997, further changes to the field release regulations were put in place by APHIS to allow the
introduction of the great majority of GE plants under the notification procedure. With this approach, a
plant is eligible for the notification process if it meets the following requirements: the plant species is not

listed as a noxious weed in the area where it is to be released; the inserted DNA is stably integrated into
the host genome; the inserted DNA’s function is known and does not cause production of an infectious

Fig. 1. USDA-APHIS field releases.


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entity; encoded substances are not toxic to nontarget species likely to feed on the plant or encode
products for pharmaceutical use; virus derived sequences must be unlikely to facilitate virulence and
spread in plants; and, finally, the new genes must not be derived from human- or animal-disease-causing
agents ([13] (p. 109–109); [11]). In other words, unless there is seen to be an environmental threat from
the new plants, the less rigorous data collection standards of the notification approach is applied. As can
be seen in Fig. 1, this led to an increase in use of the notification track as well as a decrease in utilization
of the permitting track.
Statistical analysis supports the contention that policy changes put in place since 1987 have led to
greater field release activity. Regression analysis of the effect of policy change on total field release
activity over 15 years, measured as permits plus notifications, suggests this, as the model is highly
significant and explains a good proportion of the variance (adjusted R2=0.955), while not showing

autocorrelation (Durbin –Watson = 2.070). Analysis of the parameter coefficients suggests that all
variables are significant at the 0.10 level and have a positive effect. Specifically, the year variable is
highly significant and shows an increase in, on average, 52 field releases a year since the APHIS
program was put in place. The two regulatory changes also had a significant, though lesser, effect on the
amount of field releases with the 1993 policy change accounting for an additional 229 field releases per
year and the 1997 policy change leading to an added 190 field releases a year (Table 1).
Further analysis of trends in field release through consideration of the utilization of the permitting
track bolsters the contention of the notification track replacing the permitting approach. While the model,
which incorporates both regulatory changes, does not meet model statistics, removing the effect of the
first regulatory policy change in 1993 leads to the model reaching statistical significance at the 0.10
level, although it only explains a fraction of what can be expected of a time series regression analysis and
there is suggestion of autocorrelation, meaning the model does not have the correct variables for
specification. However, what can be gleaned from the model is an increase of about eight permits a year.
The change to regulatory policy in 1997 led to a decrease in permitting activity by an order of about 96 a
year, suggesting that other factors are at work.
Finally, the 1993 APHIS policy change put in place a petition process that allowed for the
determination that certain plants are no longer regulated articles. Furthermore, an extension process,
whereby closely related plants are ascribed a nonregulated status, was put in place ([13] p. 104). Once it
has been decided by APHIS that a transgenic plant has nonregulated status, APHIS cannot exercise

Table 1
Field releases of genetically engineered plants
Total field tests
Policy change 1 (1993)
Policy change 2 (1997)
Adj. R2
* Significant at 0.10.
** Significant at 0.05.
*** Significant at 0.01.

104,290.9 (29,423.84)***
52.45 (14.79)***
229.17 (95.47)**
190.17 (95.47)*

Permits model #1
16,280.44 (12990.17)
8.213 (6.529)
2.646 (42.15)
97.146 (42.15)**

Permits model #2
15,649.19 (7902.63)*
7.90 (3.97)*
96.19 (37.79)**

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additional oversight over the plant and its descendants, even if separate deregulated lines are crossbred
conventionally. This might lead to wild species with potential weediness problems ([13] p. 111–112).
Change during the period from 1986 to 2002 can be effectively seen as occurring within the
agricultural biotechnology subsystem with minimal public input. Specifically, changes in 1992 and 1997
to USDA-APHIS field release regulations, while spurred by OSTP directives, did not incorporate public
input to any great extent. The lack of negative events, along with increased knowledge and experience
with rapidly advancing and diversifying GE plant field testing, precipitated the easing of regulations.
Furthermore, the lack of public input and likely recalcitrance to allow deregulated field experimentation
of an uncertain technology certainly accelerated this trend towards relaxed regulations.
2.3. In the public eye: on the precipice of changes to the regulatory framework 2002—??
The most recent changes to the regulatory structure concerning agricultural biotechnology are coming
about, due in great part to concerns ‘‘that the expansion in agricultural biotechnology increasingly will
put pressure on seed production and commodity handling systems’’ ([14] p. 50578) to segregate and
control its products. Further, the concomitant diversification of GE plants with agronomic properties,
consumption traits, and industrial production qualities that may enter into the environment have stirred
doubts as to their safety. Specifically, concerns over the current regulatory scheme, with its relatively
insulated policy-making approach, have been raised by three separate events at the turn of the century
that have called into question the scientific basis for regulation, the effectiveness of regulatory
enforcement, and the integrity of the food system.2
The first of these focusing events occurred in 1999 when a laboratory study published by Losey et al.
(1999) [15] in the eminent peer-reviewed scientific journal Nature called into question the environmental
safety of Bt, which was engineered to express a protein that kills targeted insects that attack
economically important crops such as corn, cotton, and potato by eating through their guts, leading
to sepsis and the inability to digest food. This article suggested that the monarch butterfly, a highly
visible symbol of the environment, as well as other beneficial insects, would be harmed by Bt corn
pollen while in their larva stage. While technically correct and seen by those in the industry as acceptable
collateral damage due to its having a negligible effect on these butterflies, this study led to a debate and
follow-up studies that lasted for over 2 years and drew a good deal of media coverage ([16] p. 189–192).
Additionally, it pointed out potential flaws in the Coordinated Framework, as the effect of pollen
that expressed Bt was not considered until after Bt corn was in the field. Specifically, the Bt corn in
question moved through the APHIS field release regulatory process, which only considers the
likelihood that a plant will become a plant pest and only indirectly considered potential harms to
nontarget species, without consideration of potential harms to such species as monarch butterflies.
EPA regulations, inasmuch as they deal with plant-incorporated protectants (PIPs)3 such as Bt crops

It is not the case that other compliance infractions have not occurred. USDA states that of the 7402 field tests carried out
between 1990 and 2001 and regulated by APHIS, 115 resulted in compliance infractions [22]. For the most part, however, these
were relatively minor infractions and did not raise public concern. Of potentially greater long-term concern were infractions
concerning EPA regulations over the management of Bt corn, in which large numbers of farmers have not been following
standards [24]. The nature of the technology and the form of EPA’s regulatory authority, however, make it difficult to observe
and punish individual infractions [26], and thus, these infractions have likewise not been of public concern.
The term PIPs (plant incorporated protectants) reflects a desire by industry to avoid the more accurate, yet more
inflammatory term ‘‘plant pesticides’’ previously used by EPA to refer to plants with engineered pesticidal qualities.


P.A. Stewart, A.J. Knight / Technological Forecasting & Social Change 72 (2005) 521–534

under FIFRA, does have regulatory authority if the pesticidal substance (the crops with PIPs) harms
nontarget species. While regulatory action was not taken, the result was that by the 2001 field season,
Ciba Seeds (Novartis), the company producing the type of Bt corn most toxic to the monarch
butterfly, removed that particular Bt corn from the market in spite of it being ‘‘a significant market
force during 1996–1999’’ ([13] p. 72–75).
The second controversy garnering national attention and concern likewise dealt with Bt corn. A variant
of Bt, which is expressed in Starlink corn and not deemed fit for human consumption due to potential
human allergic reactions but seen as safe for use as animal feed, found its way into the human food supply.
The public interest group ‘‘Genetically Engineered Foods Alert’’ performed tests on taco shells and other
corn-based products being sold in grocery stores, like Safeway, and in fast food restaurants, such as Taco
Bell, and found that these products contained Starlink Bt corn [16]. Indeed, within a single year, of
110,000 grain tests by Federal inspectors, Starlink corn showed up in one tenth [1].
The resulting uproar led to actions by EPA to cancel the registration of this corn in spite of Starlink’s
parent company Aventis attempting to win approval based on its safety as Generally Recognizable As
Safe (GRAS) from FDA. However, when this was discarded as an option, Aventis and USDA bought
back existing grain supplies and recalled food with Starlink corn in it. Further, EPA no longer allows
‘‘split’’ registrations in which PIPs may be registered for animal feed but not for human consumption. As
a result of this, public attention was drawn to flaws in the regulatory system, especially the ease in which
food security may be breached, and Congressional hearings were held to discuss this and other concerns
with agricultural biotechnology [16].
The final focusing event, that of Prodigene’s PMP corn, has likewise led to public concern over the
safety of the food supply. In September and October of 2002, in Iowa and Nebraska, respectively,
APHIS found ‘‘volunteer’’ corn plants genetically engineered to produce a pharmaceutical to prevent
‘‘traveler’s diarrhea’’ growing in soybean fields in violation of permit conditions. Specifically, Prodigene
did not abide by the conditions of their field release of PMPs from the previous year as small quantities
of this corn ended up in soybean that was to be processed and sold for human consumption. As a result
of this, Prodigene had to pay a civil penalty of US$250,000, destroy 500,000 bushels or $2.7 million
dollars worth of soybean in Nebraska, and incinerate 155 acres of corn in Iowa due to concern that crosspollination occurred, as well as post a US$1-million-dollar bond and accede to higher compliance
standards for future field tests [17]. Further, and perhaps more important in terms of long-term political
implications, the Grocery Manufacturers of America (GMA) and other food processing interest groups
expressed concern over plant made pharmaceutical field test regulations, with John R. Cady, CEO of the
National Food Processors Association commenting, ‘‘nothing short of alarming to know that at the
earliest stages of development of crops for PMPs, the most basic preventative measures were not
faithfully observed. This apparent violation of rules. . .very nearly placed the integrity of the food supply
in jeopardy.’’ [18].
As a result of these focusing events, especially the Prodigene fiasco, a certain degree of uncertainty
over the shape of the federal regulatory system was experienced,4 with a concomitant drop in permit

The state of Texas, home to Prodigene (College Station, TX) filed Texas House Bill 3387 ‘‘Prohibiting Genetically
Engineered Crops for Drugs, Industrial Chemicals, and other Non-Food Materials’’ on March 14, 2003 [30], 6 days after
USDA-APHIS Federal Register Notice concerning PMPs. This bill, which as of April 10, 2003, was left pending in the House
Agriculture and Livestock committee, would prohibit not only the growing of drugs, industrial chemicals, and other nonfood
materials in crops or livestock normally used as food or animal feed, but would also have banned the production, transport, or
release of these goods in the state of Texas (Texas HR Bill 3387).

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activity (see Fig. 1) and experimentation with PMPs (see Fig. 2). To address the decreasing trust in the
regulatory structure, OSTP published ‘‘Proposed Federal Actions To Update Field Test Requirements for
Biotechnology Derived Plants and To Establish Early Food Safety Assessments for New Proteins
Produced by Such Plants’’ in August 2002. Specifically, the notice was published to provide guidance to
USDA, EPA, and FDA to update field-testing requirements for food and feed crop plants and establish
early food safety assessments for new plant proteins, most specifically PMPs and PMIPs, in line with the
1986 Coordinated Framework.
According to the document, three principles are relied upon in updating the Coordinated Framework.
First, the level of field test confinement should be consistent with the level of environmental, human, and
animal health risk associated with the introduced proteins and trait(s). Second, if a trait or protein
presents an unacceptable or undetermined risk, field test confinement requirements would be rigorous to
restrict outcrossing or commingling of seed. Further, the occurrence of these genes or gene products
from these field tests would be prohibited in commercial seed, commodities, and processed food and
feed. Finally, even if these traits or proteins do not present a health or environmental risk, field test
requirements should still minimize the occurrence of outcrossing and commingling of seed, although
low levels of genes and gene products could be found acceptable based upon meeting applicable
regulatory standards ([14] p. 50 579).
In light of concerns raised by increased experimentation with PMPs and plants expressing industrial
compounds and addressed by OSTP in their notice [14], USDA-APHIS changed rules concerning their
field testing of PMPs in March 2003 [19]. The amount of comments in response to this Federal Register
notice reflects the changing salience concerning the field release of GE plants. While the changes to the
APHIS regulations in 1993 garnered 84 comments and the even more wide-ranging changes in 1997
attracted only 50 comments ([13] p. 104–105), the Federal Register notice concerning PMP field-testing

Fig. 2. Industrial use GE Plants and PMPs.


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requirements attracted at least 847 comments (of which 77 were late), many of them from concerned
citizens. A high percentage of comments were sent by individuals not commonly associated with the
agricultural biotechnology debate, when compared with comments to the previous two Federal Register
While critiques were raised in many comments by those who appeared to have ties with the organic
movement or with environmental groups such as Greenpeace, as evidenced by the large number of
comments received via email, concerns were raised by other politically powerful groups. GMA and
affiliated groups expressed concern over uncontained field releases of PMPs and PMIPs, especially in
food and feed plants, which account for 75% of all field releases under APHIS notification and permit
regulations. Interestingly enough, while support for a total ban on PMPs was expressed by a small
number of individuals, concern by consumer groups and traditional biotechnology opponents was
tempered, likely mitigated by the potential for medical benefits from this new technology.
While the resulting regulations are expected to be modified further over the coming years, they
currently incorporate significant changes in how PMPs and PMIPs are regulated [20]. Specifically, for all
plants genetically engineered to produce pharmaceutical and/or industrial compounds and field-tested
under permit, APHIS established seven conditions that can be grouped into three categories. The first
considers field test siting, the second considers the dedication of equipment and facilities to their
production, and the third considers procedural matters.
Field test siting regulations proposed by APHIS provide two conditions to be met, with special
consideration for pharmaceutical corn. First, the perimeter fallow zone will be increased from 25 to 50 ft
to prevent inadvertent commingling with plants to be used for food or feed. Second, production of food
and feed plants at the field test site and perimeter fallow zone will be restricted for the following season
to prevent inadvertent harvesting. Furthermore, specific permit conditions for pharmaceutical corn have
been instituted, likely due to corn being the organism of choice, accounting for three quarters of PMP
field releases [1]. The large percentage of experiments with corn derives from a variety of reasons,
including farmer experience and expertise with raising it, the ideal storage nature of its seeds, the large
amount of scientific knowledge concerning its genetics, and the ease in which its genetics are transferred
[1]. The first permit condition requires no corn grown within 1 mile of the test site during any field tests
involving open pollinated corn—an eightfold increase from standards for foundation seed. When pollen
flow is controlled by bagging, the spatial buffer is reduced to 1/2 mile, and a temporal buffer is
established with pharmaceutical corn not to be planted less than 28 days before or 28 days after corn
grown in the zone from the 1/2- to 1-mile boundary. With the establishment of these buffers, whether
they are 1/2 or 1 mile out, border rows will not be allowed to reduce the isolation distance.
A second theme concerns the dedication of farm equipment and facilities to the production of such
crops. First, APHIS requires planters and harvesters to be dedicated to the test site for the duration of
the tests, and although tractors and tillage attachments do not have to be dedicated, they have to be
cleaned in accordance with APHIS protocols. The equipment and regulated articles must be stored in
dedicated facilities for the field tests duration. The final three requirements from the proposed rules
concern procedural aspects of dealing with field tests of PMPs and plants producing industrial
compounds. First, APHIS requires the submission of cleaning procedures to minimize risk of seed
movement. Second, procedures for seed cleaning and drying are required to be submitted and approved
to confine plant material and minimize risk of seed loss or spillage. Finally, permittees will be required
to implement an APHIS-approved training program to successfully comply with the stated permit
conditions [19].

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A key factor in any regulatory arrangement is the ability to ensure that those regulated are complying
with the requirements set forth. As a result of the potentially contentious nature of PMPs and PMIPs,
APHIS plans to increase the number of field site inspections ‘‘to correspond with critical times relevant
to the confinement measures.’’ ([19] p. 11338) Therefore, in addition to maintaining records of activities
related to meeting permitting conditions and increasing the likelihood of auditing them to verify that
required permit conditions were met, APHIS might inspect permitted field tests up to five times during
the growing season—once at preplanting to evaluate the site location, once at the planting stage to verify
site coordinates and adequate cleaning of planting equipment, at midseason to verify reproduction
isolation protocols and distances, at harvest to verify cleaning of equipment and their appropriate
storage, and again at postharvest to verify cleanup of the field site. In addition, two postharvest
inspections may occur to verify that the regulated articles do not persist in the environment. Finally,
APHIS may inspect more frequently if deemed necessary. ([19] p. 11338–11339).
Possibly due to the number of responses received as a result of the Federal Register request for
comments concerning APHIS changing their PMP field release regulations and/or the vehemence of
concern voiced by those participating in the process, the potential for both PMPs and PMIPs entering
into the food supply were cited as points of concern. As a result, and using the PMP regulatory changes
as a starting point, APHIS took immediate action to remove the notification track option, requiring
complete permit track review in their recent (August 6, 2003) interim rule and request for comments. As
stated in the Federal Register notice, ‘‘. . .we believe it is prudent and necessary to remove the
notification option for all industrials pending the completion of our ongoing review of part 340.’’
([21] p. 46435).
The rationale given in the interim rule and request for comments was that while 14 field releases (nine
notifications, five permits) have been carried out to date, the type of genetic engineering being carried
out was to enhance such nutritional components as oil content. However, recent genetic modifications
have been for ‘‘nonfood traits with which APHIS has little regulatory experience or scientific
familiarity.’’ ([21] p. 46434) As such, the definition of PMIPs has three criteria: (1) the plants produce
compounds new to the plant; (2) this compound has not normally been used in food or feed; and (3) the
compound is being expressed for nonfood/feed purposes ([20] p. 46435).
An administrative reorganization of how USDA-APHIS regulates biotechnology recently created the
Biotechnology Regulatory Services (BRS). This reorganization can be seen as another move to address
concerns raised by PMPs and PMIPs specifically and GE organisms generally. According to USDAAPHIS, ‘‘Given the growing scope and complexity of biotechnology, now more than ever, APHIS
recognizes the need for more safeguards and greater transparency of the regulatory process to ensure that
all those involved in the field testing of GE crops understand and adhere to the regulations set forth by
BRS.’’ Changes instituted by BRS include new training for APHIS inspectors in auditing and
inspections of field trials, the use of new technologies such as global positioning systems, and analysis
of historical trends to inform monitoring and inspection.
According to APHIS, there are six overarching goals that the changes will serve with nine key
components being (1) enhanced and increased inspections in which risk-based criteria, along with other
factors, will be used to assess field test sites, with higher-risk sites being inspected at least once a year
and other sites being randomly selected for yearly inspections; (2) auditing and verification of records of
businesses and organizations to verify accuracy and implementation; (3) remedial measures to protect
‘‘agriculture, the food supply, and the environment in the event of compliance infraction’’ with the
establishment of a ‘‘first-responder’’ group to deal with serious infractions; (4) standardized infraction


P.A. Stewart, A.J. Knight / Technological Forecasting & Social Change 72 (2005) 521–534

resolution in which criteria will be established to determine the extent of an infraction and the response,
whether this be further investigation, the issuance of a guidance letter, the issuance of a written warning,
or referral to APHIS’ Investigative and Enforcement Services (IES) unit for further action; (5)
documentation, in which a database will be set up to track field test inspections and resulting compliance
infractions; transparency to keep stakeholders and the public informed on the regulatory decisionmaking process; (6) continuous process improvements, where as the science of biotechnology advances,
regulations and permit conditions to allow safe field testing will also do so; (7) an emergency response
protocol, being developed with input from EPA and FDA, in which a quick response plan will be put in
place ‘‘to counteract potential impacts on agriculture, the food supply, and the environment’’; (8) training
for field test inspectors in their dealings with PMP and PMIP field test sites, as well as the latest in
auditing; and (9) certification concerning compliance with the highest level of auditing standards [22].
Although the reorganization can be seen as streamlining and focusing enforcement efforts, the
potential for unduly high levels of workload stresses placed on this 26-member unit can be foreseen.
First, BRS draws on APHIS inspectors to inspect field tests; however, more than 2600 of these
agriculture quarantine inspectors have been transferred to the Department of Homeland Security (DHS)
[20]. The current agreement between USDA-APHIS and DHS allows for continued access by APHIS
and BRS, although it can be expected that problems might occur as a result of split responsibilities and

3. Conclusions
The awareness of the potential for agricultural biotechnology to transform the landscape of American
farming through the development of economically important new products, including PMPs and PMIPs,
has long been recognized. Just less than 10 years ago, this journal devoted a special issue to
‘‘Biotechnology and the Future of Agriculture and Natural Resources’’ [23]. Then, uncertainty over
the future of agricultural biotechnology was based upon the lack of financial support for research and
development as well as vague and unfocused regulations [24]. These same concerns exist now in spite of
better characterized biotechnology-based science and technology and a better understanding of economic
and ecological risks and benefits.
The concerns over the new agricultural biotechnology are often termed as one in which the issue is
less about the science of GE crops and more about the social issues in which this technology is nested.
This ‘‘surrogate for safety’’ is a reflection on the idea that ‘‘in many areas of life there is less and less
control. For some segments food offers some control.’’ [25]. The threat of drugs and medicines, as well
as a variety of industrial compounds, entering the food supply through normal production channels can
be seen as particularly dreaded by the American public, which, while largely unaware of the extent of
genetically modified products in their food supply, have been attenuated to threats to their security since
9-11. In spite of the lack of evidence of human disability through consumption of GE foods, concern has
increasingly been raised in the European Union, which is establishing labeling standards, and Africa,
where GE corn destined for famine relief was turned down due to health and ecological concerns.
While the history of field release of genetically modified plants had been one of technical domination
by insiders, with regulatory change largely ignored by the general public, recent events involving threats
to monarch butterflies by Bt corn, potentially allergenic Starlink Bt corn meant solely for animal feed
entering the U.S. food supply, and PMPs produced by Prodigene nearly entering the American food

P.A. Stewart, A.J. Knight / Technological Forecasting & Social Change 72 (2005) 521–534


system have alerted the American public to potential threats, rupturing the previously insular policy
subsystem. While these events provide evidence that the regulatory system is being successfully
implemented, their occurrence has drawn attention to gaps in the Coordinated Framework.
At least two recent events have the potential to further expand the scope of concern and thus conflict.
A report by the Center for Science in the Public Interest (CSPI) called into question the enforcement of
guidelines set by EPA requiring growers using Bt corn to set aside land as refuge for pest management
purposes [26]. Here, corporations have been called upon to regulate farmers directly due to the use of
preexisting pesticide regulations under the Coordinated Framework—a task for which they are not well
suited [27]. And most recently, on November 12, 2003, a coalition of environmental groups and
consumer advocates sued USDA in federal court to stop the field testing of PMPs due to lack of risk
assessment concerning other crops, wildlife, and humans [28].
In light of these concerns and reflected in the rapidly changing field release regulations of PMPs and
PMIPs put forward for comment in the Federal Register in March and August of 2003, there is a high
likelihood that the Coordinated Framework for the Regulation of Biotechnology will continue to change.
Whether this change will occur in the form of marginal alterations in the regulatory approach by EPA,
FDA, and USDA, especially in the case of the latter with the newly constituted APHIS-BRS, while
retaining the Coordinated Framework, or a major change in the regulations through the creation of a new
agency or approach, remains to be seen. As more becomes known about this still young technology and
its potential for health, ecotoxicological and ecological effects, as well as the complex and nonlinear
environment it operates in, the more likely negative side effects will be discovered and dealt with.
Already, both USDA-APHIS and EPA are strengthening their ties with each other with monthly
coordinated phone calls and are enhancing transparency and ties with stakeholders through public
workshops and meetings. Additionally, greater attention is being given to different means of approaching
ecological control of these products, in light of a newly released National Academy of Sciences report on
the biological confinement of GE organisms [29].
Regardless, new agricultural–environmental biotechnologies stand on a precipice of change. Over the
next 15 years, they may continue to change how food, drugs, and industrial products are produced, or
they may be yet another failed technology along the lines of nuclear power with its plants withdrawn
from farmers’ fields, depending on how issues dealing with public trust in regulations are addressed. In
either case, it is social support for the technology and trust in regulatory institutions that matter most.
This report was funded by the Arkansas Biosciences Institute, Arkansas State University.

[1] N.C. Ellstrand, Going to ‘great lengths’ to prevent the escape of genes that produce specialty chemicals, Plant Physiol. 132
(2003 August) 1770 – 1774.
[2] Pew, Harvest on the horizon: future uses of agricultural biotechnology, The Pew Initiative on Food and Biotechnology (2001 September).
[3] P.A. Sabatier, H.C. Jenkins-Smith, The advocacy coalition framework: an assessment, in: P.A. Sabatier (Ed.), Theoretical
Lenses on Public Policy, Westview Press, Boulder, CO, 1999, pp. 117 – 166.





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J.W. Kingdon, Agendas, Alternatives, and Public Policies, Harper Collins, New York, 1984.
P. Berg, et al., Potential biohazards of recombinant DNA molecules, Science 185 (1974) 303.
S. Krimsky, Biotechnics and Society: The Rise of Industrial Genetics, Praeger, New York, 1991.
S. Wright, Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, University of
Chicago Press, Chicago, IL, 1994, pp. 1972 – 1982.
R.W.F. Hardy, D.J. Glass, Our investment: what is at stake, Issues Sci. Technol. (1985 Spring) 69 – 82.
S. Krimsky, R. Wrubel, Agricultural Biotechnology and the Environment: Science, Policy and Social Issues, University of
Illinois Press, Chicago, IL, 1996.
P.A. Stewart, A.A. Sorensen, Federal uncertainty or inconsistency? Releasing the new agricultural – environmental biotechnology into the fields, Polit. Life Sci. 19 (1) (2002) 77 – 88.
USDA (U.S. Department of Agriculture), Introduction of organisms and products altered or produced through genetic
engineering which are plant pests or which there is reason to believe are plant pests, 52 Fed. Regis

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