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July 31, 2003


Science and Politics of Biotech; No Paradise for Pharming; Rethi


Today in AgBioView: August 1, 2003:

* The Science and Politics of Plant Biotechnology -- A Personal
* No Paradise for Pharming
* Rethinking US Leadership in Food Biotechnology
* Happy & Healthy in a Chemical
* Regulation of Biotech Crops and Food in the United States and Canada

The Science and Politics of Plant Biotechnology -- A Personal Perspective

- Indra K Vasil, Nature Biotechnology, Vol. 21 No. 8 p 849; August 2003
www.nature.com. Reproduced in AgBioView with permission from the author
and the editor.

Indra K. Vasil is at the University of Florida, Box 110690, Gainesville,
Florida 32611-0690, USA. This commentary is adapted from his presidential
address to the 10th Congress of the International Association for Plant
Tissue Culture & Biotechnology (IAPTC&B), held June 23ˆ28, 2002. e-mail:

The debate on the virtues and perils of biotechnology in the production of
transgenic crops that started in 1983 has intensified and become quite
contentious with the commercialization of transgenic foods in recent
years. It has become political and emotional to the extent that it is now
delaying and/or preventing the worldwide adoption of this important
technology in addressing critical and urgent problems of food security and
the environment. The following is my perspective on the science and
politics of plant biotechnology.

Having considered all of the technologies known to us today, and the
various arguments of the anti-biotechnology lobby, I remain more convinced
than ever that plant biotechnology is still the best hope not only for
meeting the food needs of the ever-growing human population, but also for
conserving our precious but dwindling land and water resources and
preventing or even reversing environmental degradation. Food production
will have to be tripled to meet the demand for food of the nearly 12
billion expected inhabitants of the Earth in 20501,2, including the
hundreds of millions of people in China and India whose dietary
requirements are changing as a result of their improved buying power.

The international agricultural community faces this challenge at a time
when population is growing faster than increases in food productivity,
when the quality and quantity of fresh water supplies are declining3, when
there is less land per capita available for food production, when more
than 42% of crop productivity is lost owing to various biotic/abiotic
factors4, and when the widespread use of agro-chemicals is causing
significant soil and water pollution (Table 1). The increasing demand for
food, therefore, will have to be met primarily by increasing productivity
on land already under cultivation, with less water and under worsening
environmental conditions.

The science Plant biotechnology came of age with the first-ever large
scale commercial planting of transgenic crops in 1996. This milestone was
achieved after years of intensive work devoted to the development of
efficient and reliable systems for the regeneration of normal fertile
plants from cultured cells, and of methods for the introduction and stable
integration of alien genes into cultured plant cells. The first generation
of transgenic crops now being grown has been engineered for resistance to
herbicides (soybeans, canola), insects (cotton, maize) and viruses (papaya
and squash)1.

By eliminating, or significantly reducing, the losses caused by weeds,
pests and pathogens, transgenic crops increase productivity and thus help
to conserve land, water, energy and other resources that would be needed
otherwise to produce the same amount of food with nontransgenic plants.
The worldwide acreage devoted to these crops has grown steadily from only
about 5 million acres in 1996 to nearly 200 million acres in 2003. This
trend is likely to continue with increased planting of transgenic crops in
China, India and several other countries. In the United States, 80% of
soybeans, 70% of cotton and 38% of maize planted in 2003 were transgenic.
The total market for transgenic seed now exceeds $3 billion.

Plant biotechnology is thus no longer an abstract science with only
promise and potential, but rather a powerful agricultural technology that
is beginning to increase productivity by reducing or eliminating losses
caused by weeds, pests and pathogens. It is also having a positive impact
on human health and the environment by reducing the use of
agro-chemicals--nearly 5,000 people die each year because of pesticide
poisoning, a number that is already being significantly reduced in China,
South Africa and other countries with the introduction of insectresistant
cotton and accompanying decrease in pesticide use--and by contributing to
the conservation of biodiversity, arable land, water and energy sources.

A wide variety of useful genes have been introduced into many food and
fiber crops in the past few years in order to improve their overall
quality and/or nutritional value and resistance to a variety of biotic and
abiotic stresses1,5,6 (Table 2).More than 50 such crops have been approved
for commercial plantings, and at least 100 more are undergoing field
trials and/or regulatory review. This second generation of transgenic
plants is expected to be released for commercial production and human use
during the next ten years.

Biopharming (molecular pharming) is one of the most promising emerging
areas of research and development that uses transgenic plants for the
production of vaccines, human therapeutic and prophylactic proteins and
pharmaceuticals1. These include drugs for the treatment of cystic
fibrosis, hepatitis B, non-Hodgkin lymphoma, diarrhea, cholera, diabetes
and other diseases. Most of these drugs and vaccines are currently being
produced in maize and tobacco, and some in potato, tomato and banana.
Biopharming is very attractive to the pharmaceutical industry as it
significantly reduces the cost and time for the production of drugs. A
large number of drugs produced in transgenic plants are now in various
states of field and human clinical trials.

Rapid progress has been made during the past decade in the sequencing of
plant genomes, and in understanding the structure, function and regulation
of genes. These studies are contributing greatly to our understanding of
the molecular basis of the growth and development of plants. This is
particularly important because most of our major crops have reached the
physiological limits of productivity. It is no longer possible to
significantly increase the yield in these crops by conventional breeding
methods. The introduction and manipulation of genes involved in tillering,
flowering, size and number of seeds, nutrient assimilation and
photosynthetic efficiency, by genetic transformation have been shown to
result in a significant increase in yield7ˆ12. The third generation of
transgenic plants that will be better adapted to a variety of biotic and
abiotic stresses, that will provide increased yields and more nutritious
and healthful food, and that will produce a variety of drugs and
pharmaceuticals for the treatment of human and animal diseases is expected
to be available for human use after 2015 (ref. 1; Box 1).

Ongoing research shows clearly that many novel transgenic crops and
products for a variety of uses--including food, human health, and
environment--will be available in the future (Tables 1ˆ3). Clearly, the
impact of plant biotechnology on human health and the environment is just
beginning; the best is yet to come.

The science behind transgenic plants is sound, precise and predictable.
Once a gene of interest has been identified, it is isolated and sequenced.
Its function and the protein coded by it are determined. It is then
introduced into a crop variety that has been found to be suitable for
genetic transformation and regeneration. Scores of independently
transformed lines are rigorously tested and evaluated in the laboratory,
greenhouse and in the field for several generations for genetic uniformity
and agronomic performance.

Selected lines are then backcrossed into elite breeding stock for variety
development and undergo further exhaustive testing for yield and overall
performance, environmental/ecological effects, nutritional value,
allergenicity and other qualities. Only then, after regulatory approval,
are they released for commercial production. This level of testing is far
in excess of the testing to which similar plant varieties developed by
breeding and selection are ever subjected.

I do not subscribe to the view that plant biotechnology is a magic bullet
that will solve the problems of food security and the environment. New
varieties will continue to be developed by traditional breeding and
selection. Biotechnology‚s contribution will be to improve these varieties
further by the introduction of characteristics, such as those listed in
Tables 2 and 3, that cannot be manipulated or transferred with
conventional methods. Molecular and traditional breeding should complement
and supplement each other.

The politics
Transgenic crops/products are among the most exhaustively tested,
characterized and regulated plants in history. There have been tens of
thousands of field trials of transgenic crops in the past two decades.
Since 1996, transgenic crops have been grown on more than 400 million
acres, and have provided food for hundreds of millions of humans in many
countries. Yet, there is not a single documented instance of Œdamage‚ to
the environment (despite some instances of outcrossing) or of ill effects
on human or animal health13ˆ16. Based on these facts, and on extensive
published scientific evidence, it is the consensus of the international
scientific community, the regulatory authorities in many countries,
several of the most respected and well-known national scientific academies
and medical societies, various organs of the United Nations, and others
that transgenic crops and their products are at least as safe for humans
and the environment as crops developed by conventional methods.

In spite of the overwhelming scientific evidence of the safety of
transgenic crops/products, and the urgency of adopting this technology to
meet future needs, antibiotechnology activists continue to call for a
moratorium or outright ban on the planting and/or use of transgenic crops.
Their rhetoric is alarming and frightening to the public but lacks
substance. These groups continue to insist that transgenic crops are
unsafe without offering any credible scientific evidence to support their

The consumer, the farmer and the biotechnology industry have all been ill
served, indeed held hostage, by the sustained campaign of misinformation
and unsubstantiated claims of dangers to public health and the
environment. The antibiotechnology movement is clearly based on political
and ideological opposition to biotechnology and globalization, rather than
any real scientific concerns. The five-year moratorium on transgenic crops
by the European Union and some other western European countries is a
protectionist maneuver and an appeasement of certain political parties.

In my view, obstructing or otherwise impeding the introduction of
transgenic crops, particularly in the most populous and least developed
countries, which not only need but stand to benefit most from this
technology, is morally and socially irresponsible and indefensible, and a
disservice to the peoples of those countries.

The biotechnology community--academia and industry alike--must share at
least some of the blame for the hostility of the anti-biotechnology groups
and the difficulties being faced in the commercialization of transgenic
crops. In the early days of the biotechnology revolution (the 1970s), but
particularly after the production of the first transgenic crops in 1983,
we deliberately distanced ourselves from plant breeding and genetics and
presented plant biotechnology and transgenic plants as something entirely

Indeed, it was claimed by some that this technology would replace
traditional plant breeding. This gave the necessary ammunition to the
anti-biotechnology lobby to describe transgenic plants as unnatural and
dangerous, and also alienated plant breeders. In reality, as has now been
demonstrated, transgenic technology is no different from breeding except
that it is inherently more precise and predictable. Furthermore, the first
transgenic plants that were released for mass cultivation were engineered
for resistance to herbicides and still are the most widely cultivated
transgenic crops. They do not offer any direct and immediate benefit to
the consumer. Rather, they perpetuate the myth that transgenic technology
is largely for the benefit of the agro-chemical industry.

Finally, until about ten years ago, the biotechnology community had
neglected to inform and engage the public and the consumer. This had
allowed the opponents of plant biotechnology to take the initiative in
presenting a highly distorted and misleading account to the public. These
problems are beginning to be resolved by the development of more healthful
and nutritious transgenic crops and products that are of immediate
interest and benefit to the consumer, and by increased emphasis on public

The solution
The enviable and unblemished record of transgenic crops and their products
is the strongest evidence for their safety and wholesomeness. It has been
repeatedly shown that the risks to human health and the environment from
transgenic crops are no different from those of plants developed by
conventional breeding and selection. Accordingly, risk assessment and
regulation of transgenic crops should not be any different from the
procedures used to evaluate plants developed by conventional methods. The
rules and regulations developed for the evaluation and approval of
transgenic crops have served their purpose well. They have shown
unambiguously that transgenic crops and foods are safe and do not pose any
risk to human health and the environment. Continued imposition of
expensive (field trials of transgenic crops are 10ˆ20 times more expensive
than those of conventional crops), time-consuming and scientifically
unjustifiable regulations needlessly delays the introduction and use of
transgenic crops and products that promote food security, enhance human
health and protect the environment.

By crying wolf much too often, the opponents of transgenic crops have not
only lost their credibility, but also the right to be taken seriously.
This indictment of the antibiotechnology lobby may seem harsh, but it is
entirely deserved. Time has come to gradually relax and eventually suspend
the regulation of transgenic crops. Regulatory decisions should be made in
an open and transparent manner, and be based on science rather than
emotions and perceived risks.

A beginning should be made by removing all restrictions on the cultivation
and use of transgenic crops that have fulfilled regulatory requirements
and have been cultivated and/or used for five years without any ill
effects on humans or the environment. These include herbicide-resistant
soybean and canola, insect-resistant maize and cotton, and virus-resistant
squash and papaya. New transgenic crops with similar genes should not be
required to meet the regulatory requirements for more than two years,
unless there are clear signs of risks. Crops with genes that have not been
previously tested under field conditions should be monitored for a period
of two to five years, and then released for unrestricted cultivation
unless proven to be harmful. Crops engineered for the production of drugs
and vaccines should be physically isolated from all other crops to prevent
accidental pollination of nontransgenic plants.

Two decades ago the United States pioneered the rules and regulations
governing the development, testing, field release and use of transgenic
plants and their products. It should now lead similarly by gradually
relaxing and eventually eliminating the regulatory oversight of transgenic
plants, except in those instances where there is a likelihood of risk to
human health and the environment. Like all other foods, let the future of
transgenic crops be determined by the farmer, the consumer and the

Transgenic crops rightly deserve to be an integral part of international
agriculture in the twenty-first century. Let us not delay the application
of this very useful and indeed humanitarian technology for political

My own confidence in plant biotechnology comes from knowing that the
science behind it is sound, that it is well tested and proven, that it
benefits the consumer, the farmer and the industry, and that it protects
and conserves the environment. It is for these reasons that I am convinced
that the many needless obstacles being placed in the way of this
technology will be overcome and that it will within the next two decades
become an integral part of the international agricultural system. With
China, India and the United States, the three most populous countries in
the world, serving as examples, we have taken the first decisive steps
toward achieving that objective.

1. Vasil, I.K. (ed.). Plant Biotechnology 2002 and Beyond (Kluwer Academic
Publishers, Dordrecht, The Netherlands, 2003).
2. Population Reference Bureau, Washington, DC. (2002).
3. United Nations. Vital Water Graphics. Water Use and Management (United
Nations Educational Scientific & Cultural Organization, Paris, 2002).
4. Oerke, E.-C., Dehne, H.-W., Schöbeck, F. & Weber, A. Crop Production
and Crop Protection (Elsevier, Amsterdam, 1994).
5. Herman, E.M., Helm, R.M., Jung, R. & Kinney, A.J. Plant Physiol. 132,
36ˆ43 (2003).
6. Horvath, H. et al. Proc. Nat. Acad. Sci. USA 100, 364ˆ369 (2003).
7. Li, X. et al. Nature 422, 618ˆ621 (2003).
8. Hayama, R., Yokoi, S., Tamaki, S., Yano, M. & Shimamoto, K. Nature 422,
719ˆ722 (2003).
9. Ku, M.S.B. et al. Novartis Foundation Symposium 236, 100ˆ111 (2001).
10. Ku, M.S.B. et al. Nat. Biotechnol. 17, 76ˆ80 (1999).
11. Hedden, P. Trends Genet. 19, 5ˆ9 (2003).
12. Jenner, H.L. Trends Biotechnol. 21, 190ˆ192 (2003).
13. Kuiper, H.A., Kleter, G.A., Noteborn, H.P.J.M. & Kok, E.J. The Plant
J. 27, 503ˆ528 (2001).
14. Nap, J.-P., Metz, P.L.J., Escaler, M. & Conner, A.J. The Plant J.
33,1ˆ18 (2003).
15. Conner, A.J., Glare, T.R. & Nap, J.-P. The Plant J. 33, 19ˆ46 (2003).
16. Qaim, M. & Zilberman, D. Science 299, 900ˆ902 (2003).

Box 1 The third generation of transgenic crops--2015 and beyond Sequencing
of Arabidopsis thaliana and rice genomes has been completed; others in
various stages of sequencing are Lotus, Brassica, maize, Medicago, poplar,
barley, wheat, tomato, potato, soybean and pine. This information, coupled
with functional genomics, will be of direct benefit to plant breeding.
Synteny discovered in cereal genomes will be of significant value in the
search for important genes. The discovery and characterization of
dwarfing/green revolution genes (e.g., Rht in wheat, sd1 in rice, and
gibberellin-insensitive in A. thaliana) and tillering genes in rice will
be of much help in manipulating fruit, and seed size and number affecting
productivity. Recent work has shown that photosynthetic efficiency and the
number of grains produced can be significantly increased by the
introduction of some of the key maize genes involved in C4 photosynthesis
into rice; such plants are also more tolerant to abiotic conditions (see
Table 3).

Table 1 Increasing population and declining resources
* Population is growing faster than increases in food productivity
* Food production per capita, based on cereal grains, has been declining
for nearly two decades
* Per capita arable land will decline from 0.26 hectare in 1997 to 0.15 in
* Water covers 70% of the Earth‚s surface, yet fresh water comprises only
2.5% of Earth‚s water.
Most of it lies frozen in polar ice caps and glaciers. Less than 1% of
total water is available for human use, including agriculture, which
accounts for more than 70% of human use of water
* It is estimated that over the next two decades the average supply of
water per person will drop by
a third, and as many as 7 billion people in 60 countries may face water
scarcity by 2050

Table 2 Second generation of transgenic crops: 2005ˆ2015
* Resistant to herbicides, pests and pathogens
* Tolerant to drought, salt, heavy metals and low/high temperatures
* Improved nutritional quality (proteins, oils, vitamins, minerals)
* Improved shelf life of fruits and vegetables
* Improved flavors and fragrances
* Elimination of allergens
* Production of vaccines, human therapeutic proteins, pharmaceuticals
* Phytoremediation

Table 3 Traits of third-generation crops
* Genome sequencing/Functional genomics/Molecular breeding
* Altered plant architecture
* Manipulation of flowering time
* Manipulation of fruit and seed quality, size and number
* Improved photosynthetic efficiency
* Improved nutrient assimilation
* Exploiting and manipulating heterosis and apomixis

Note from Prakash:
Prof. Vasil is Graduate Research Professor Emeritus in plant molecular and
cell biology at the University of Florida. He has nearly 50 years of
research and teaching experience in the field of plant biotechnology. He
has more than 400 publications to his credit, including 24 books. He has
lectured extensively throughout the world, and has been involved in major
international biotechnology training programs for the past 25 years. He is
the immediate past president of the International Association of Plant
Tissue Culture & Biotechnology, the largest international professional
organization in plant biotechnology. He has been identified by the
Institute of Scientific Information (publishers of Current Contents and
Citation Index) as one of the world's top 100 most cited influential
authors in plant and animal sciences (http://www.isihighlycited.com).


No Paradise for Pharming

- Charles Q Choi, The Scientist, July 30, 2003

Lawsuit seeking information on Hawaii test fields is just the beginning,
activists say.

Environmental groups are suing for public access to Hawaii state
agricultural records concerning field tests of genetically modified (GM)
crops. Attorneys expect that the legal action represents the beginning of
further activism in Hawaii, now the leading US hotspot for agricultural
biotechnology trials.

Attorney Isaac Moriwake of the environmentalist law firm Earthjustice told
The Scientist that federal records show 14 permits for biopharming, or
growing drugs with genetically altered plants, in Hawaii were issued
between 1999 and 2002. However, the permits do not specify where test
plots are, which genes are undergoing alteration, or what kind of
substance is being produced.

"Among concerns we have with these field tests is they use food crops, and
they take place in open air. There are also unique ecosystems in Hawaii
with a great concentration of endangered species that could be affected if
plants get out of field trial areas," said Joseph Mendelson, legal
director of the Center for Food Safety, a national watchdog group in
Washington, D.C. Mendelson cited past incidents of possible food crop
contamination by pharmed crops grown by ProdiGene in the mainland United

Hawaii's balmy winters allow firms to grow crops in open-air field trials
year-round, said Biotechnology Industry Organization spokeswoman Lisa Dry.
Experiments are being conducted there on corn, tobacco, soy, papaya,
cotton, rice, sunflowers, and wheat by Dow, Monsanto, DuPont, ProdiGene,
Syngenta, and other biotech giants, as well as by academic institutions
such as the University of Arizona and Iowa State University.

"Biotechnology saved the $17 million papaya industry in Hawaii," Dry
added, noting that biotech research developed a papaya resistant to the
ringspot virus that was destroying the industry.

Local concern about GM crops grew in Hawaii after the US Environmental
Protection Agency cited biotech leaders Dow AgroSciences of Indiana and
Pioneer Hi-Bred International of Iowa for not following regulations in
their Hawaii plantings to segregate GM corn from other corn. Both settled
with the government in December 2002 without admitting wrongdoing. Dow
paid a fine of $8800 and Pioneer paid $9900.

On May 23, the Center for Food Safety asked the Hawaii Department of
Agriculture for all documents regarding ongoing field tests in Hawaii, but
the department refused. On July 23, Earthjustice filed suit against the
Circuit Court of Hawaii, First Circuit, on behalf of the Center for Food
Safety, to compel the state to provide public access to details about the
field tests.

"The law requires state agencies to grant the public open access to its
records," Moriwake said.

The US Department of Agriculture declined to comment on litigation
affecting state agencies or itself. A spokeswoman for the Hawaii
Department of Agriculture said, "The State Attorney General's Office is
reviewing the lawsuit and it would be inappropriate for the department to
comment at this time."

"We want to make sure the state department of agriculture has a rigorous
review of field trials. This could reveal Hawaii hasn't been real
vigilant, just rubber-stamping trials," Mendelson said.

Dry sharply disagreed. "There is stringent federal and local oversight of
field trials, including those for plant-made pharmaceuticals. It is a slur
against the regulatory agencies to suggest they fail to carry out their
duties," she said.

"These issues are going to become of ever greater concern to national
organizations and people living in Hawaii," Moriwake said. "One of the big
purposes of this suit is to kick-start a larger investigation and campaign
to increase public awareness. First we need to gain access to these


Rethinking US Leadership in Food Biotechnology

- Michael R. Taylor, Nature Biotechnology, Vol. 21 No. 8 p 852 - 854;
August 2003 www.nature.com. Reproduced in AgBioView with permission from
the author and the editor.
Michael R. Taylor is a senior fellow at Resources for the Future, 1616 P
Street, NW Washington, DC 20036, USA. e-mail: taylor@rff.org

The Bush Administration in the United States announced in May it would
challenge the European de facto moratorium on approval of genetically
modified (GM) food crops in the World Trade Organization (Geneva,
Switzerland). This follows several years of campaigning by the US
government and industry to gain acceptance in Europe of GM crops and foods
that US citizens consider, with good reason, to be safe. But the United
States cannot successfully litigate its way to public acceptance of

I've watched the battle for public acceptance of food biotechnology since
the beginning, from positions at the US Food and Drug Administration (FDA;
Rockville, MD, USA) and US Department of Agriculture (USDA; Washington,
DC, USA), a stint as a policy advisor at Monsanto (St. Louis, MO, USA),
and now as a public policy researcher interested in African agriculture.
And I'm convinced the United States is on the wrong strategic track. The
US government and biotechnology industry are pushing too hard to get
people to say yes to biotechnology on US terms; and the United States has
been too strident—harshly criticizing Zambia and Zimbabwe for not
accepting biotech food aid and calling Europeans "immoral" and "Luddites"
(the words of US Trade Representative Robert Zoellick) for their stance on
biotechnology. For many in the US camp, biotechnology is based on good
science; it's safe; and that should be the end of the discussion.

It's fine to support and promote agricultural biotechnology on its
scientific merits, but the public reaction to biotechnology--in America,
Europe, and Africa--has only a little to do with science. Good science
makes biotechnology possible and contributes to answering some of the
questions people have, but no amount of science or science education will
suffice to achieve public acceptance. US proponents of biotechnology,
inside and outside government, need to embrace and address the social
dimension of biotechnology acceptance.

The stakes in this debate are high. Biotechnology is helping US farmers
grow corn, cotton and soybeans more efficiently and, in some cases, with
less use of toxic insecticides, but the worldwide pattern of controversy,
resistance and polarization surrounding biotechnology threatens its future
adoption for food purposes, in the United States and elsewhere. Wheat
growers and processors alike are cautioning Monsanto not to proceed with a
GM version of this staple crop until global public acceptance improves.

This resistance has economic consequences for technology developers and
for US farmers, but resistance to food biotechnology has much broader
social consequences if it blocks adoption of the technology to help solve
the drought, pest, plant disease and other productivity-limiting problems
that plague farmers in Africa.

Gordon Conway, the president of The Rockefeller Foundation, believes
biotechnology can help bring a 'doubly green' revolution to African
farmers, who were largely bypassed by the first green revolution. This
means achieving desperately needed productivity gains at much lower
environmental cost in the form of pesticide pollution and water and energy
use. By splicing genes in, modern biotechnology can put the valuable
agronomic performance trait inside the plant rather than having to
manipulate the environment outside the plant.

Biotechnology is no silver bullet for African agriculture, but it has real
potential to improve farmer productivity and, in conjunction with many
other needed policy reforms and infrastructure investments, help reduce
poverty and hunger in that struggling region. This is deeply in the
economic, security and humanitarian interests of the United States.

With the stakes so high, how can the United States get its public
acceptance strategy and biotech leadership role right? The starting point
is to tackle the following questions: first, who are the beneficiaries of
the technology; second, have the risks been addressed by institutions
people trust; and third, has the public's right to choose been respected?

Who benefits from food biotechnology?
Biotechnology has been readily accepted in medicine because the benefits
are tangible, and they are enjoyed by the same person who experiences any
real or perceived risk. Food biotechnology, as commercialized to date, has
no direct consumer benefits. The benefits go predominately to the
technology provider and farmers, while any real or perceived risks are
borne by consumers.

This lack of consumer benefits contributes to the rather skittish public
attitude toward GM foods. Many US citizens say they would rather avoid GM
foods, and most GM crops are used for animal feed or other non-food uses.
If required to label ingredients derived from genetically modified corn
and soy, food manufacturers say they would rather reformulate to eliminate
those ingredients.

In Europe, neither farmers nor consumers benefit from American-produced GM
crops, which makes it easy and predictable for Europe to adopt a cautious,
risk-adverse stance. Other social factors undergird European resistance to
food biotechnology, including different cultural attitudes toward food and
agriculture, the lack of trust in regulatory institutions, and the
economic interests of European farmers; but it's hard to get a consumer
product like food off the ground without consumer benefits.

Though lacking direct consumer benefits, food biotechnology at least
potentially has benefits that American and European consumers experience
indirectly, such as the environmental benefit of reduced pesticide use and
the social benefit of improving agriculture and food security in
developing countries. People value these benefits, but it is far from
clear they are willing to subject themselves to any personal risk (real or
perceived) to acquire benefits that are remote from their personal

In Africa, the benefits issue is more complicated. Many Africans see the
potential for biotechnology to improve agriculture and in turn help reduce
poverty and hunger. These benefits will come, however, not from the GM
corn and soybean crops that work for US farmers but from use of the
technology to improve locally adapted crops and seed and solve the
particular problems of African farmers.

Have food safety and environmental issues been addressed by trusted
The United States' GM soybeans had the misfortune to debut in Europe in
the wake of the UK and European food safety crisis involving mad cow
disease. The same politicians, regulators, and scientists who erroneously
said mad cow disease could never pass from cows to humans were telling
consumers the soybeans were safe. The public didn't buy it, and European
Union (Brussels, Belgium) officials have been struggling ever since to
build public confidence in regulatory oversight of GM crops and foods.

In the United States, food biotechnology has benefited from the
traditionally high public trust in the FDA, which has primary jurisdiction
over the safety of biotechnology foods. The FDA's reputation as a consumer
protection agency is based on its longstanding scientific tradition and
its independence from politics, which should be protected. Questions are
now being raised about the US biotechnology regulatory system, however,
that can be addressed only by the US Congress, such as whether GM foods
should be subject to mandatory premarket approval by FDA. Today, they are
not. Some in consumer, industry and legislative circles think they should
be, if only to maintain public confidence in the technology.

The potential environmental issues surrounding GM crops tend to be more
complex and uncertain scientifically than the food safety issues, and the
US National Academy of Sciences (Washington, DC, USA) and other groups
have recommended enhancement of how the US regulatory system handles them.
The public resonance of environmental issues was demonstrated by the
uproar that ensued when questions were raised a few years ago about the
possible threat of GM crops to the Monarch butterfly.

In Africa, credible regulation of GM crops and foods will be as important
to acceptance of biotechnology as it is in Europe and the United States.
As demonstrated by the recent experience with GM food aid in Zambia,
Africans will make their own decisions about biotechnology, including
whether GM crops and foods meet local safety standards. Zambia and other
African nations are actively developing regulatory systems for
biotechnology, but their progress requires building scientific and
institutional capacities that are in short supply today. It is unrealistic
to expect public acceptance in Africa until these capacities are in place.

Has the public's right to choose been respected?
The right to choose is central to the European debate about food
biotechnology. In both Europe and the United States, some people object to
the use of biotechnology in agriculture for a host of reasons independent
of safety, including cultural, economic, ethical and other personal
preference reasons. They insist on the right to choose whether or not to
consume GM foods. The European Commission is in the process of adopting
labeling and other requirements to preserve this right, which Europeans
have made a prerequisite to resuming approval of GM crops and foods.

In the United States, there are continuing calls for the labeling of GM
foods based on the right to choose, but the choice issue has been far less
intense than in Europe. Last year, a labeling referendum, strongly opposed
by the biotechnology and food industries, was defeated at the polls in
Oregon. The choice issue has played out instead in the growth of the
organic sector of the food market (where government standards prohibit
biotechnology crops) and in actions of baby food companies and other food
marketers that have removed GM ingredients from their products in response
to consumer demands.

The choice issue takes a different form, too, in Africa. African farmers
and consumers will accept biotechnology based on their decision that it is
good for them, not because it is good for someone else and not when it is
controlled by others and offered as the only option. The reluctance to
have the technology imposed was at least one factor in the Zambian
decision last year initially to reject GM food aid from the United States.
The Zambians had other options for meeting their dire food needs and chose
not to accept GM corn under pressure and under someone else's conditions.

The way forward
What does this understanding of the public acceptance situation say about
the US leadership role? It says most fundamentally that if biotechnology
is to achieve its full potential in the world, the United States needs to
step back from its aggressive advocacy stance and develop a food
biotechnology agenda that recognizes that people won't accept food
biotechnology under pressure. They need and deserve to have their
questions answered, and the United States should focus on doing what it
can to answer them. Here are a few specific things the United States can

Broaden the benefits. On the consumer front, it's up to the technology
companies to develop products that directly benefit consumers. A more
strategic, long-term approach to public acceptance by the companies would
include increased R&D spending for this purpose.

To broaden environmental benefits, the government could create economic
and regulatory incentives for reducing pesticide use through application
of biotechnology and other means; rigorously evaluate and report the
environmental benefits of current biotech crops; and strengthen the focus
of USDA's agricultural research program on environmentally beneficial
applications of biotechnology.

In Africa and other developing countries, multinational biotechnology
companies have little economic incentive to invest in new commercial seed
products for the benefit of poor farmers, which means such innovation is
largely a public sector responsibility. The US government should increase
US funding of the World Bank–sponsored international agricultural research
system and the national systems in African countries to support their
matching of local germplasm with the traits that are needed to solve local
farming problems.

The United States should adopt technology transfer policies that keep
government-funded biotechnology research and tools in the public domain
for developing country purposes and encourage private sector sharing of
patented technologies to help developing country farmers. The Rockefeller
Foundation (New York, NY, USA) is supporting the creation of the African
Agricultural Technology Foundation to serve as a repository and conduit
for technologies and know-how that companies are willing to make available
on a noncommercial basis for use in Africa. The government could encourage
such sharing and public-private collaboration with economic incentives (in
the form of tax credits or other subsidies) and by addressing the
liability concerns of companies who fear being held liable for
consequences from uses of their products they do not control.

The goal of all of these efforts would be to move biotechnology from the
realm of promise to a broader sharing of concrete benefits.

Strengthen safety assurances. The US regulatory system has worked well to
ensure that the biotechnology crops and foods on the market today are safe
for human health and the environment. The government should, however,
adopt the recommendations made recently by a committee of the US National
Academy of Sciences to enhance postcommercialization monitoring of
biotechnology crops for unanticipated environmental impacts; and Congress
should convert FDA's voluntary premarket notification system for
biotechnology foods into a mandatory approval system.

The need to establish acceptable health and environmental safety assurance
systems is most acute in Africa, where the resources are most limited. The
US should make investment in regulatory capacity a key element of its
biotechnology and agricultural development agenda.

Empower people to choose. In the end, biotechnology will fulfill its full
potential in a society only if it is freely chosen by that society. The
United States should be on the side of empowering choice. Because the
choice issue arises differently in different countries, there is no one
approach that fits everywhere. In the EU, labeling of GM foods and
GM-derived ingredients is the preferred approach, whereas in the United
States, it is, so far, reliance on organic standards and the optional use
of labels identifying non-GM foods. Africa will make its own decision
about how to empower choice. If African countries take a labeling
approach, the United States should support it.

The United States and the major US agbiotech companies have positioned
themselves in the eyes of many as opposing choice by virtue of their
aggressive promotion of the technology, their opposition to labeling
worldwide, and most recently by resorting to trade remedies to force
Europe's hand. Nothing could be more destructive of trust in the
technology and its promoters than for them to be on the wrong side of the
choice issue. They should change their position and put themselves on the
side of empowering choice in whatever way works in any given country.

By adopting a choice-based agenda, the United States can remake its
leadership on biotechnology and prepare the way for biotechnology to
achieve its full potential as a tool for farmers and consumers alike.


Happy & Healthy in a Chemical World

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Regulation of Biotech Crops and Food in the United States and Canada

- Whybiotech.com

All biotech crops grown in North America must go through years of rigorous
testing before they are brought to market. Before they ever reach a
farmer's field or a family's dinner table, biotech crops undergo years of
rigorous testing to ensure that they are safe for people, animals and the

In fact, biotech varieties in North America are tested more thoroughly
than conventional crops.1 One type of biotech soybean alone was subjected
to 1,800 separate analyses before it reached farmers's fields on a
commercial scale.2

A variety of scientific organizations -- ranging from the National Academy
of Sciences in the United States to the Royal Society in the United
Kingdom 3 -- have recognized the safety of food developed with
biotechnology for both the environment and to eat.

"Crops produced through biotechnology have proven to be as safe as or
safer than crops produced by conventional breeding," wrote University of
Illinois professor Bruce Chassy, an expert on the regulation of biotech
crops and foods.4

In Canada and the United States, biotech products are regulated under the
same framework that is used to determine the safety of their
conventionally bred counterparts. The underlying principle at work is that
approvals should be based on the characteristics of the end products
rather than the process by which they are made.

And because biotech crops now on the market have been found to be
"substantially equivalent" to their conventional counterparts and pose no
greater risks, Canada and the United States do not require special
labeling. If a biotech crop or food were different-- such as having
additional nutritional qualities -- then labels would be required.

It can take more than a decade for the testing and regulatory process to
be completed in the United States. "From the first steps of discovery to
final regulatory approval and product launch, the research and development
process for a new genetically modified plant variety can take as long as
from six to 12 years and can cost from $50 million to $300 million," said
a February 2003 report titled, "Agricultural Biotechnology at the
Crossroads," by Bio Economic Research Associates. "For each gene or trait
explored in the discovery phase, the odds are roughly 1 in 250 that the
gene or trait will make it into a commercial product." 5

Thorough review process
In the United States, the safety of biotech food is overseen by three
separate agencies.

* The Food and Drug Administration (FDA) assesses the safety of all
biotech plant products intended for consumption by humans and animals. 6
* The Department of Agriculture (USDA), through its Animal and Plant
Health Inspection Service (APHIS), oversees field testing of biotech seeds
and plants to make sure their release causes no harm to agriculture and
the environment.
* The Environmental Protection Agency (EPA) evaluates biotech plants'
environmental safety — such as their pesticide properties, possible effect
on wildlife and how these plants break down in the environment. The agency
also must approve any herbicide use with herbicide-tolerant crops.7

In Canada, there are six steps that must be taken before foods developed
with biotechnology can be approved. 8 Three agencies oversee the
regulation of biotech products.
* Canadian Food Inspection Agency
* Health Canada
* Environment Canada

In Mexico, CIBIOGEM, which includes six national ministries (including
Agriculture, Food and the Environment), and the Mexican Council of Science
and Technology, regulate biotech food and crops.

In all three countries, many products come under review by more than one
agency. Bt corn, for example, which is enhanced to produce its own
naturally occurring protein to ward off insect pests, could be reviewed by
the USDA to ensure it's safe to grow, by the EPA to confirm it's safe for
the environment and by the FDA to make sure it's safe to eat.9 Academics,
third-party scientists, consumers, growers and the public at large all
have multiple opportunities to participate in the review process.

If the research is promising, the developer can apply to APHIS to conduct
limited field tests of a genetically engineered plant. APHIS' role is to
ensure that these enhanced crops pose no unwanted effects on agricultural
health or the environment. 10 Companies must submit detailed applications
explaining what plant variety will be tested, how the test will be
conducted and what steps will be taken to confine the tests to ensure that
pollen and plants will not escape into the environment. 11

Government regulators supervise critical steps in the process, such as the
transport of seeds to and from trial sites. 12 To bolster this regulatory
oversight, APHIS created a new office — Biotechnology Regulatory Services
--in June 2002 to better coordinate its scientific and regulatory
expertise in the biotechnology arena. 13 And it is expanding its oversight
capabilities. Where 305 field test inspections were conducted in 2002,
APHIS expects to conduct twice that number in the 2003 growing season,
according to David Hegwood, a special counsel for the USDA. 14

The U.S. EPA becomes involved in the regulatory oversight of biotech crops
when they are modified to reduce insect damage 15-- Bt corn or cotton, for
example. The EPA conducts thorough safety assessments to determine what
effects, if any, such enhanced crops could have on the environment,
wildlife and nontarget insects, and to design strategies to reduce the
likelihood insects could become resistant to these new crops.

"For example, during the review of the Bt potato, a test of potential
effects of the introduced protein to lady beetles was conducted and showed
that there were no adverse effects to these predators of the pesky
Colorado potato beetles," said EPA Assistant Administrator Stephen Johnson
in testimony before a U.S. House Agriculture subcommittee June 17, 2003.
"For Bt corn, tests were conducted on the potential effects on fish
because field corn may be manufactured into commercial fish food. No
effects were observed in the tests." 16

Following an incident in the fall of 2000 when traces of a type of Bt corn
(StarLink), which was approved for use as animal feed but not for human
consumption, was found in taco shells, the EPA changed its procedure to
assure such a mishap does not occur again. The EPA now does not grant
separate approval for a crop to be used in animal feed when the crop can
also be used for human consumption.17

The FDA enters the regulatory picture when a biotech plant is to be used
in food. "Bioengineered foods and food ingredients must adhere to the same
standards of safety under the Food, Drug and Cosmetic Act that apply to
conventionally bred counterparts," said FDA Deputy Commissioner Lester
Crawford in testimony before a U.S. House Agriculture subcommittee June
17, 2003. "This means that these products must be as safe as the
traditional foods in the market." 18

Since the approval of the FlavrSavr tomato in 1994, every developer of
biotech foods has, without exception, consulted with the FDA on a
voluntary basis to preemptively address any safety or nutrition concerns
before the product reaches the marketplace.19 In 2001, responding to the
public's desire for a more formal, transparent process, the FDA proposed
new guidelines that will make consultation mandatory.

"The agency is in the process of evaluating the more than 100,000 comments
received," said Crawford. "The proposal has raised policy and legal
concerns and is not a pressing public health priority for FDA, given that
there is a voluntary consultation process in place that is working well."
20 The FDA has also begun posting biotech food information supplied by
manufacturers on its Web site.21

In Canada, a report that resulted from a two-year study by the Canadian
Biotechnology Advisory Committee said that although the regulatory process
could be improved, biotech foods currently on the market are safe. "GM
foods currently in the marketplace have arguably undergone greater
regulatory scrutiny than their conventional counterparts," the report
said. 22 "We conclude that no scientific evidence exists to suggest that
GM plants and foods currently in the market pose any greater health or
environmental risk than other foods." 23

Ongoing assessments
Review doesn't stop once products finally reach farm fields and dinner
plates. Post-approval monitoring by the product developer, independent
researchers and government scientists helps ensure that biotech crops
continue to be safe for consumers and the environment. In 2002, for
example, the EPA re-approved Bt cotton and Bt corn after carefully
reviewing concerns about potential insect resistance to Bt products and
their effect on monarch butterflies.

Testing for allergies
Careful testing and regulation have ensured that biotech foods are safe,
and there has never been a single documented biotech-related health
problem for consumers.

Researchers have examined many of the health and safety concerns that have
been raised about biotech foods -- such as the possibility, for example,
that consuming modified foods could lead to allergic reactions.

Professor Steve Taylor of the University of Nebraska, a leading allergy
expert, says that evaluating food for its allergenic potential is a key
part of the R&D and regulatory process. He said that 90 percent of food
allergies are caused by a handful of known allergens that can be easily
identified and avoided when biotech crops and foods are developed. Taylor
also believes that biotechnology is a promising tool for removing
allergens from foods, which would give many allergy-prone people a wider
choice of safe foods to eat.16

Critics of biotechnology often point to a case in which a gene from the
Brazil nut, which can cause allergies, was added to a soybean to increase
its levels of methionine and improve its value as an animal feed. 24 In
fact, early in the development process tests for allergenicity were
conducted and, when problems were detected, the product was scrapped. 25

"[It] would be a significant loss to humanity if the many benefits of
biotechnology were not realized because of concerns that have little basis
in scientific fact," says Brian Larkins, president of the American Society
of Plant Physiologists and professor of plant science at the University of

More Links and references at http://www.whybiotech.com/index.asp?id=3199