Today in AgBioView Special from www.agbioworld.org : September 27, 2004
* World Hunger and Biotechnology Debated
* Vatican Urges Further Study of Genetically Engineered Food
* View from Bishop Sorondo, Chancellor of the Pontifical Academy of Sciences
* U.S. Regulation of Biotech Foods - FDA Chief
* Use of 'GM Food Plants' to Combat Hunger in the World
- Study-Document from the Pontifical Academy of Sciences
World Hunger and Biotechnology Debated
- John L. Allen Jr., National Catholic Reporter, Sept 26, 2004
The adjective "relentless" seems coined for figures such as James
Nicholson, the United States' Ambassador to the Holy See. Since his
arrival in 2001, Nicholson has been a relentless advocate for the
Bush administration in its dealings with the Vatican. Among other
things, this put him in the awkward position of defending the Iraq
war, even as Pope John Paul II emerged as one of its leading critics.
Yet Nicholson persevered, and has impressed Vatican officials with
his zeal, if not always with the substance of American positions.
Nicholson is at it again this week, this time on genetically modified
organisms, or "GMOs." It may seem an odd priority for an ambassador
to the Vatican, but Nicholson understands that resistance to GMOs,
which form an increasingly important component of the American
biotechnology industry, is not just scientific, but political and
moral. Voices in the developing world argue that GMOs are a
boondoggle for giant First World biotech companies, without adequate
assurances about their impact on the environment, human health, or
traditional farming practices.
These considerations have already led the Zambian, South African and
Brazilian bishops to express doubts about GMOs. If the Vatican were
to do the same, the bad publicity could have serious repercussions
for American companies such as Monsanto. (By 2001, more than 109
million acres worldwide were planted with bioengineered crops). In
part for that reason, in part out of genuine conviction that
biotechnology can help solve the problem of global hunger, Nicholson
rarely misses an occasion to make the case.
All of which brings us to today's conference at the Gregorian
University, co-sponsored by the U.S. Embassy to the Vatican and the
Pontifical Academy of Sciences, titled "Feeding a Hungry World: The
Moral Imperative of Biotechnology."
Even before the conference began, critics were claiming that the deck
was stacked with pro-GMO voices. Holy Cross Br. David Andrews,
executive director of the National Catholic Rural Life Conference in
the United States, charged in a Sept. 20 statement that "the
Pontifical Academy of Sciences has allowed itself to be subordinated
to the United States government's insistent advocacy of biotechnology
and of the companies which market it."
Andrews did not mince words. "Surely, among the structures of sin in
the world today are agro-food corporations that steer the goods of
the earth toward themselves solely for profit," he said. "If one
thinks that the focus of these multi-national corporations and their
supporters is to cure world hunger, then one is among the most naïve
on the planet."
In essence, Andrews charged that the Pontifical Academy has been
bought off by American biotech interests. "It reminds me of many
state sponsored universities in the United States which take funds
from biotechnology companies and lose their scientific critical
culture for one of uncritical endorsement of the agenda of the
companies which fund their research," he said.
Advocates of GMO were by no means willing to cede the moral high
ground at the Gregorian conference. They argued that faced with a
world in which 13,000 people die of hunger every day, technology that
promises to produce more food at a lower cost, using less land and
other resources, amounts to a moral obligation.
"Some environmentalists, consumer groups and members of churches have
challenged the overwhelming scientific evidence on the benefits of
biotechnology and have succeeded in sowing fear among some
governments in the developing world," Nicholson said "The worst form
of cultural imperialism is to deny others the opportunities we have
to take advantage of new technologies to raise up our human
condition," Nicholson said.
Peter Raven, a professor of biology at Washington University in St.
Louis and a member of the Pontifical Academy of Sciences, was even
more pointed. Referring to arguments such as those of Lessups and
Henriot that distribution, not production, is the key to solving
hunger, Raven warned against the "escapist statement that there's
plenty of food," calling it "in a practical sense absurd." Two
billion more people will be added to the human population before it
reaches stability, he said, and by 2025 half of those people will be
living in regions facing severe water shortages. Meanwhile, land once
available for agriculture continues to be gobbled up by urban sprawl.
Developing higher-yield crops that need less water, he said, is
There is no documented case, Raven said, of any human or animal
illness anywhere in the world attributable to GMOs. Virtually all of
the beer and cheese now consumed around the world, he said, uses
biologically engineered materials.
Raven was dismissive of fears that GMOs would unleash new diseases or
create other health consequences. "To a mother in a famine-struck
region of Africa, the disease is hunger and the cure is food," he
said. "The efforts of Greenpeace [to oppose GMOs] are doubtless
helpful to the finances of an organization that does not spend one
cent to alleviate starvation, but they are outrageous and should be
rejected out of hand by any moral person."
Perhaps the most compelling testimony of the day came from farmers
from the developing world. Edwin Y. Paraluman of the Philippines
reported that he planted genetically modified corn on his farm at a
time when most Filipinos rabidly opposed it; there was even a rumor,
he said, that walking in a field with GMO crops could make someone
gay. Yet his crop yield went up, the crops were safe, and as a result
of his increased earnings, he was able to buy a refrigerator and a
motorcycle for his family.
Sabina Khoza from South Africa, who described herself as "a very,
very proud indigenous woman in agriculture," said that her
genetically modified corn had a similar impact on her life. She asked
for a round of applause for her smart blue business suit, saying, "If
it weren't for biotechnology I wouldn't be dressed like this."
Khoza also insisted that the food is safe. "We are growers and
farmers, and we are the very first consumers," she said. "Whatever I
plant, I've eaten and consumed before it goes to the market. Here I
Lester Crawford of the U.S. Food and Drug Administration described
the extensive testing process followed in the Unites States to ensure
food safety. "To date, bioengineered foods have proven to be no
different from their conventional counterparts," he said. Crawford
noted that 68 percent of the soybeans in the United States, 70
percent of the cotton crop, 26 percent of corn and 55 percent of
canola are genetically engineered.
Legionaries of Christ Fr. Gonzalo Miranda provided a theological
framework, arguing that "it is not Christian" to argue that human
beings are prohibited from altering plants and animals with
technology, because there is an "ontological difference" between
humans and the rest of creation. Hence there is no intrinsic problem
with GMOs, Miranda suggested, and they should be evaluated on a
Bishop Marcelo Sánchez Sorondo, chancellor of the Pontifical Academy
of Sciences, did not take a direct position on the GMO issue. He did,
however, refer to a 2004 publication of the academy, "Study Document
on the Use of 'Genetically Modified Food Plants' to Combat Hunger in
the World," that took a cautiously supportive stance. "Genetically
modified food plants can play an important role in improving
nutrition and agricultural products, especially in the developing
world," it concluded.
Raven, Sánchez noted, was a primary contributor to that document.
Some critics note that Raven is also the director of the Missouri
Botanical Gardens in St. Louis, which receives financial support from
the Monsanto corporation; the Monsanto Fund, for example, recently
committed $1 million toward construction of a new children's garden.
Vatican sources told NCR Sept. 24 that an explicit statement on
genetically modified crops is unlikely from the Holy See in the near
future, but that most officials seem inclined to give it a "yellow
light," meaning "proceed with caution."
Vatican Urges Further Study of Genetically Engineered Food
- Sabina Castelfranco, Voice of America, Rome, Sept. 26 2004
Listen to Sabina Castelfranco's report (RealAudio) at
Efforts to combat world hunger have led to increased attention on
biotechnology, not only by farmers looking to produce more and better
quality food, but now also by the Vatican. Church officials said at a
recent U.S.- and Vatican-sponsored conference on the subject that it
is a moral imperative to investigate the potential of this technology
to meet global food needs.
Despite existing prejudice and concerns about biotechnology in many
countries, Vatican officials believe genetic engineering is a modern
science tool that should be explored to address hunger and
malnutrition in the world.
The U.N. Food and Agriculture Organization (FAO) expects the world's
population to grow to more than eight billion by 2030. The food
agency projects that, during the next three decades, global food
production must increase by 60 percent to accommodate the estimated
At a conference held Friday in Rome, scientists, experts in
agricultural development, farmers and church officials shared their
views on modern genetic technology. Dr. C.S. Prakash, a professor of
plant molecular genetics, said biotechnology is a very powerful tool
that can be used in the developing world to grow more food in an
"Biotechnology can improve farming," he said. "It can improve our
food production by making farming more efficient, by reducing the use
of chemicals on the farms, including pesticides and how much
fertilizers that we apply. And, also, biotechnology can bring in an
element of profitability to farming by producing novel products."
But there are plenty of critics and much skepticism in Europe and the
developing world. Some see the move by large multi-national
corporations to sell genetically modified seeds and products to the
developing world as an over-simplified solution to hunger.
Father Sean McDonagh, a Irish missionary who spent many years in the
Philippines, says the benefits of genetically modified crops are
still uncertain and more studies are needed. "It is not yet clear
what the impact will be on human health, and actually, what the
impact will also be on the environment," he said. "People will say it
is only a minimal risk, that is so, but the consequences of the risk
could be horrendous."
Critics add there will be damaging effects to biodiversity that are
difficult to predict and quantify. But Dr. Prakash says there is
absolutely nothing to show that genetically modified crops could
negatively impact biodiversity. To the contrary, he says,
biotechnology will conserve and enhance biodiversity.
"When you stop using chemicals in the farm you will have more
friendlier insects on the farm, far more weeds and far more birds
coming into your farm, and the fact that you can produce more with
less land means that you are going to have more of wild lands that
are not being cut down," explained Dr. Prakash.
Opponents of biotechnology also say multi-nationals are only driven
by profits. Father McDonagh explains that these companies are trying
to control food production in the world by making growers dependent
on their products.
"Food is a common good. Now it has been treated in the
biotechnological world as another commodity, like your mobile phone
or your watch. It is not that," said Father McDonagh. "You can get on
without your watch, even without your mobile phone. You cannot get on
Dr. Prakash says that, while profits always drive innovation in
companies, no one is being forced to buy a product that is not
considered useful. He adds that farmers who embrace genetically
engineered seeds feel it is bringing added value to their crops.
"Discounting this valuable technology just because a few
multi-national corporations are bringing that, is trying to deny the
benefit of this technology to people based on ideological grounds,"
Participants in the Rome conference insisted biotechnology is just a
tool, and like any tool, it must be used properly and with care for
it to be safe and beneficial. They also agreed that effective
distribution networks for the food, as well as appropriate policies
are also needed if significant results are to be achieved in
decreasing world hunger.
Moral Imperative or Dangerous Dream?
- Vatican Radio, September 23, 2004
Friday marks the beginning of a conference on the potential benefits
of genetically modified foods, held at the Pontifical Gregorian
Listen to the Interview with U. S. Ambassador Jim Nicholson, C. S.
Prakash and Father Rodrigo Perret, head of Franciscan Office for
Justice and Peace in Rome .... at
Feeding a Hungry World: The Moral Imperative of Biotechnology
- Bishop Marcelo Sánchez Sorondo, Chancellor of the Pontifical
Academy of Sciences; Presentation made at the conference "Feeding a
Hungry World: The Moral Imperative of Biotechnology" on September 24,
2004 organized by the U.S. Embassy to the Holy See in cooperation
with the Pontifical Academy of Sciences at the Pontifical Gregorian
University, Rome, Italy
My introductory word is an invitation to read the document that the
Pontifical Academy of Sciences produced in 2001 and in which this
whole complex problem is studied with a scientific approach as well
as with the necessary considerations for justice.
The following final recommendation stands as an example of this: "In
order to help governments, state-funded researchers, and private
companies to meet the above conditions, and in order to facilitate
the development of common standards and approaches to this problem in
both developing and industrialised countries, the scientific
community, represented by its established worldwide umbrella
organisations, should offer its expertise. A suitably composed
international scientific advisory committee could be entrusted with
this all-important task."
Regarding the issue that has brought us here today, it is our hope
that we can go deep into it in order to collaborate to solve what
Paul VI called "the drama of hunger in the world". As you probably
know, according to a recent document by the London School of
Economics, "Child Poverty in the Developing World", 674 million
children in the world live in conditions of absolute poverty. On the
other hand, the latest estimations of the Food and Agriculture
Organization of the United Nations show that 840 million people in
the world suffer from chronic malnutrition. Such a drama - which the
Church has been the first to denounce through its Social Teaching-
goes against the basic human condition.
In my view, two kinds of questions arise when we attempt to solve
this drama through GE foods: those concerning the hard sciences and
those relating to the political sciences (i.e., a problem of
international and national justice).
In the first place, it is necessary to know whether this type of food
has harmful effects on the health of human beings and on the
environment. In this sense, there is some recent important news: the
US National Academy of Sciences and the French Academy of Sciences
have both approved this kind of food. The US National Academy of
Sciences produced a document named "Safety of Genetically Engineered
Foods: Approaches to Assessing Unintended Health Effects" (27 July
2004). Genetic engineering is not an inherently hazardous process,
the report says, but the resulting food, along with foods created
from other methods of genetic modification, should be examined to
determine if the inserted genes produce toxins or allergens.
Unexpected changes are more apt to occur if genetic material is
transferred between distantly related species. Genetic engineering is
more likely to cause unintended changes than some techniques, such as
simple selection, but less likely to do so than other currently used
methods, such as those that use radiation or chemicals. Because all
methods can cause these changes, the committee concluded that
attempts to assess food safety based solely on the method of breeding
are "scientifically unjustified."
Personally, I find it hard to believe that modern sciences and
technologies cannot help to alleviate starvation.
About the question of justice or the distribution of the goods,
naturally, the interests behind GE foods are huge, especially from
Northern agribusiness companies, but a healthy political orientation
in order to achieve the common good and justice could mean a decisive
change in favour of the poor people and children.
As you are probably aware, with the participation of Cardinal Sodano,
President Lula da Silva led a summit on hunger together with other
world leaders in New York earlier this week. As he pointed out, "how
many more times will it be necessary to repeat that the most
destructive weapon of mass destruction in the world is poverty?"
In line with many of these opinions, namely that held by Kofi Annan,
I think that we need to explore all possibilities, both old and new,
to solve this "drama". With traditional methods only, we are not
likely to reach the objectives set forth by the "Zero Hunger
Programme" by 2015, as the Millennium Goals Declaration has promised
the poor. If things remain as they are, "the fight against poverty is
one hundred years away from fulfilling its goals and promises" as
predicted by Gordon Brown, the British Chancellor of the Exchequer,
who added: "the richest countries cannot continue to establish goals
without fulfilling them systematically and hoping that the poorest
countries calmly continue to believe in us."
Naturally, many other things should be changed in order to narrow the
increasing rich-poor gap, such as introducing a general tax that all
countries would pay according to their wealth and that would then be
distributed among the poor. In this sense, Lula has proposed a number
of ideas to help raise money for the poor, which include eliminating
agricultural subsidies, taxing the trade of certain weapons, imposing
a small tax in current tax havens, earmarking a percentage of
corporate turnover, creating special bonds and raising outlays from
the International Monetary Fund. Similarly, Jean-Pierre Landau has
urged the developed countries to reduce the cost of agricultural
exports to the developing countries.
To conclude I would like to quote Cardinal Sodano, who said that this
emergency must be "faced with a series of complex factors, such as,
for example, the need to invest in the human capital of the local
populations (I am thinking of education and health issues), to
encourage the transfer of the appropriate technologies, and to
guarantee fairness in international trade. This, however, must not
discourage the definition of a series of programmes to eradicate
hunger and thirst in the world".
Coming back to the specific issue of GE foods, I would like to refer
to what is happening now in Argentina to exemplify this question of
justice. Monsanto -the provider of technology-based agricultural
products- wants to collect royalties for the use of their transgenic
soybean seeds. The government and the farmers strongly oppose this.
Naturally, money is necessary in order to continue research on the
development of these seeds, but let me add the recommendation 12 of
the Study Document of the Pontifical Academy of Sciences:
"Intellectual property rights should not inhibit a wide access to
beneficial applications of scientific knowledge. In the development
of this modern genetic technology for agriculture, efforts should be
made to facilitate cooperation between the public and private sectors
and to secure the promotion of solidarity between the industrialised
and developing worlds."
And here is where justice -both national and international- comes
into play. For it belongs to justice to render to each one his own
and to judge what the rights of each party are. For this reason, it
is very important that all people and institutions voice their views
and organise meetings to discuss this complex problem.
A final consideration could be made. The Vatican is a State that
tries to collaborate with the Holy Father in Peter's mission of
evangelization. The Pontifical Academy of Sciences carries out such
collaboration through the careful study and discussion of scientific
questions. The conclusions of the Academy do not represent the
official Teachings of the Church, so they are free to be debated on.
If the Pontifical Academy of Sciences does not take care of these
problems that are primary to people, what other problems should it
address? I can promise you that I will proceed with extreme prudence
given the many important reasons that you remark. Please, let us pray
so that our meeting can contribute to a new order with more justice.
U.S. Regulation of Biotech Foods
- Lester M. Crawford, Acting Commissioner of the FDA; Speech before
The U.S. Vatican Mission's Conference "Feeding A Hungry World: The
Moral Imperative Of Biotechnology" (This text contains Dr. Crawford's
prepared remarks. It should be used with the understanding that some
material may have been added or deleted during actual delivery.)
Good Afternoon, I'd like to thank Ambassador Nicholson (Jim
Nicholson, Ambassador, American Embassy to the Holy See) for his kind
introduction and for his invitation to speak to you this afternoon
about U.S. regulatory policies for biotech foods, or as we refer to
them in the United States, genetically engineered foods.
It is indeed both an honor and a privilege to be here today and
share with you the many ways that the United States government
assures the safety of genetically engineered foods so that scientific
advances in food production may benefit not only the American people,
but people throughout the world.
I would like to commend the forward thinking and support of the Holy
See in recognizing and publicly acknowledging the potential for the
technology of genetically engineered foods to be part of the
framework of the Vatican's efforts to promote human dignity by
eradicating poverty, hunger, and malnutrition and promoting economic
well-being. The U.S. especially applauds the support of the Holy See
for a science-based approach to this issue.
Already today at this conference you have heard how the scientific
advances in genetically engineered crops offer new promise not only
for feeding the millions of hungry people around the world, but also
for improving the nutrition and health of all people. You have also
heard how biotech food crops can aid developing countries in reaching
food sufficiency and enhancing their economic development, and how
small farmers in Africa and the Philippines are already using
genetically engineered food crops to their advantage.
It is my pleasure to share with you today the extensive system of
safeguards that the U.S. government has in place to assure the safety
of genetically engineered foods not only for the American people, but
also for people around the world who import U.S. food crops and
manufactured foods, and for those who receive U. S. food crops as
food aid through the United Nations World Food Programme.
The United States has more experience in the regulation of
genetically engineered foods than any other country in the world. In
1986, under the guidance of the White House Office of Science and
Technology Policy, the United States developed a coordinated
framework for the regulation of genetically engineered products. The
decision was made that genetically engineered products (foods and
drugs) would be regulated under existing legal authorities, and that
safety assessments would be based on product characteristics. In
other words, the U.S. regulates the product and not the process by
which the product was developed. The U.S. Government agencies
directly involved in these regulatory policies include the Department
of Health and Human Services' Food and Drug Administration (FDA) and
National Institutes of Health (NIH), the Department of Agriculture
(USDA) and the Environmental Protection Agency (EPA).
The distribution of responsibilities among these agencies is clear.
The USDA oversees the safety for the cultivation of genetically
engineered crops and addresses plant protection issues. The EPA is
responsible for overseeing the safe use of pesticides, including
pesticidal substances produced in genetically engineered plants. EPA
also sets tolerances or establishes exemption of tolerance for these
pesticidal compounds in foods and in the environment. The NIH, as the
premier research agency in the U.S. Government establishes the
guidelines for recombinant DNA research. The FDA, the agency I
represent, has the major responsibility for assuring the safety and
proper labeling of foods, feed, and pharmaceutical substances derived
from genetically engineered plants. The agency's statutory authority
for these activities are codified in the Federal Food Drug and
Cosmetic Act which gives FDA oversight of all cereals, fruits,
vegetables, plant by-products, milk, seafood, and all substances
added to foods. FDA also is responsible for post-market monitoring of
foods for adulteration, for pre-marketing approval of food additives,
and for assuring appropriate labeling of food products.
In 1990, the first food additive produced through genetic
engineering, a form of chymosin, a milk-clotting enzyme used for
cheese production, was affirmed as being virtually identical to its
natural counterpart and granted GRAS status (generally recognized as
The first genetically engineered whole food crop was introduced into
commercial production in the U.S. in 1994. By 2001, more than 109
million acres worldwide were planted with bioengineered crops and
this acreage has continued to grow.
The United States accounts for about two-thirds of all the
bioengineered crops planted globally. The social and economic
benefits derived from the use of genetically engineered food crops
has been widely recognized by U.S. farmers, to the extent that, as of
2002, at least 68 percent of the soybean crop planted in the U.S.
consisted of genetically engineered varieties along with
approximately 26 percent of the corn crop, over 70 percent of the
cotton crop, and about 55 percent of the canola crop.
Most of these genetically engineered crop varieties consist of
herbicide or insect resistant varieties. These types of crop
varieties could be invaluable to developing countries in helping them
toward food sufficiency. Opportunities abound for the development of
genetically engineered crop varieties with enhanced nutritional
content such as the increased vitamin A content of golden rice that
can improve the health and nutritional status of those most in need.
U. S. Government Policy for Genetically Engineered Foods
The FDA established its basic policy on genetically engineered foods
in 1992. This is the policy, along with subsequent clarifications
that is in effect today. This " Policy on Foods Derived from New
Plant Varieties" was published to provide guidance to developers and
producers of new plant varieties, and applies to all methods of plant
breeding, including techniques using recombinant DNA.
The basic principles in this policy statement are: 1) that the
regulation of new plant varieties should be based on the objective
characteristics or components of the food, rather than the method
used to develop the food; 2) new foods must be as safe as foods
already on the market; and, 3) new plant varieties are evaluated
relative to traditional counterparts.
New substances introduced into food via plant breeding (either
traditional or bioengineered) are considered food additives if they
are not GRAS or pesticides.
In 1995, we provided additional guidance on a voluntary consultation
process whereby producers of genetically engineered foods voluntarily
notify the agency before marketing a bioengineered crop seed or food.
This prior notification is to ensure that new food products are safe
and lawful. Genetically engineered crops are evaluated on a
case-by-case basis, there is no "required' battery of tests. The
level of consultation needed is dependent on the novelty of the
genetically engineered product.
Notification leads to a two-part consultative process that involves
a discussion of relevant safety, nutritional, and other regulatory
issues and a subsequent submission by the developer of a safety
assessment report. The safety assessment involves a
multi-disciplinary approach that includes the agronomic and quality
characteristics of the plant, the characteristics of new substances
that are introduced into the plant through genetic engineering, a
genetic analysis, and a chemical and nutritional analysis.
All foods, whether conventional or bioengineered, pose the same types
of inherent risks to human health: the potential to contain toxins,
allergens, and antinutrients. Safety assessments for bioengineered
foods thus should focus on whether the genetic change alters the
potential toxicity, allergenicity or level of antinutrients compared
to the conventional food source. In addition, FDA encourages an
evaluation of the safety of intended changes to nutrient composition
and compositional analysis for unintended changes.
Specific elements of the safety evaluation include:
1) Analysis of the intended modification or new substance relative to
its identity, source, digestibility, dietary exposure and nutrition
2) Analysis of unintended modifications as to the genetic stability
over multiple generations, analysis of nutrient, anti-nutrient and
3) Characteristics of the host plant, including its taxonomy, history
of safe use, normal presence of harmful constituents and important
4) Characteristics of the donor organism including its taxonomy,
history of use, presence of harmful constituents, passage through
microbial hosts, and the identity and function of the introduced
5) Analysis of the substance introduced into the host plant including
the concentration of the expression product, its potential for
allergenicity and for toxicity, its similarity to other substances in
the food supply, and whether it causes alterations in plant
6) Evaluation of the inserted genetic material in terms of the
methods of transformation used, the activity of the regulatory
sequences of the gene the number of inserts and insertion sites, and
its genetic stability.
FDA also developed additional guidance for the food industry
regarding safety assessments for the use of antibiotic resistance
marker genes in bioengineered plants. This guidance indicated that
when such genes are used, the safety assessment should also determine
whether the presence in food of the enzyme or protein encoded by the
antibiotic resistance marker gene would compromise the therapeutic
efficiency of orally administered antibiotics through transfer of the
gene from plants to microorganisms in the gut of man or animal, or in
More recently we issued draft guidance for industry on voluntary
labeling to indicate whether foods have or have not been developed
using bioengineering. This document lays out four guiding principles
on appropriate ways the industry could voluntarily provide
information on a food label about bioengineering.
To date, bioengineered foods have proven to be no different from
their conventional counterparts and so, although FDA issued a
proposed rule in 2001 concerning making the voluntary notification of
intent to market mandatory, this rule has not yet been finalized and
the voluntary notification procedures remain in effect.
I'm pleased to report that to date all developers of bioengineered
foods have voluntarily consulted with FDA prior to marketing their
products, and FDA maintains a listing of these completed
consultations on our website. I am also pleased to tell you that the
procedures that the U.S. Government has had in place for assuring the
safety of genetically engineered foods since 1992 are fully
compatible with the Principles and Guidelines on Foods Derived from
Biotechnology adopted by the Codex Alimentarius in July of 2003.
While it is true that FDA evaluates genetically engineered foods for
the U.S. population, the U.S. has a very ethnically and racially
diverse population that also includes large numbers of sick and
elderly. Thus, assurance of safety for the extremely diverse U.S.
population should reflect its safety for non-U.S. populations. FDA
would not allow a food to be marketed if it believed that the food
would cause harm for some segment of the population, unless the food
could be clearly labeled to alert specific sub-populations (e.g.
those with allergic reactions).
The characteristics of genetically engineered varieties of food
crops, available to date, have focused primarily on insertion of
genes that confer herbicide or pest resistance or both to the plant,
or alter ripening characteristics or oilseed composition. There is no
scientific evidence to indicate that there would be a greater risk to
consumers or the environment if these crops were grown in developing
countries rather than in the United States.
To ensure that U.S. policies and procedures on genetically engineered
foods stay current with the latest scientific and technological
advances, the FDA has a group of outside experts who serve on the
Food Biotechnology Subcommittee of the Food Advisory Committee, and
provide advice on science-based approaches to assessing potential
In addition, FDA in conjunction with USDA and EPA commissioned the
U.S. National Academy of Sciences and the Institute of Medicine to
develop a science-based framework to assess or predict unintended
health effects of genetically engineered foods to assist us in our
evaluation of these products prior to commercialization. This report
was released at the end of July of this year and outlined a decision
tree for the safety assessment of genetically engineered foods that
tracks closely with FDA's current procedures. The report also
confirms FDA's belief that the genetically engineered foods evaluated
by the agency and marketed to date, do not pose unexpected health
concerns for consumers.
We are currently nearing completion of a draft guidance concerning
field trials of bioengineered food crops. The development of this
guidance is a high priority for the Administration and the industry,
to enhance public confidence, avoid product recalls, and provide an
international model to address the presence of low levels of
bioengineered plant material in non-bioengineered crop fields.
The goal of this guidance is to ensure that material from field
trials is safe prior to any inadvertent entry into the food supply.
In essence, this would be the protein safety component of a full
voluntary consultation relative to the protein's toxicity or
allergenicity. It would not replace the full consult prior to
With continued and rapid advances in biotechnology come many new and
interesting challenges for FDA. The production of food crops
engineered to produce pharmaceutical and industrial compounds is one
of these challenges. While FDA has sole responsibility for ensuring
the safety and efficacy of the pharmaceutical products produced by
plants for use in humans, we share the responsibility for ensuring
the safety of these products developed for use in animals with USDA.
Currently, FDA is considering an adventitious presence guidance
document analogous to that for food-use crops.
However, if a genetically engineered plant whose new characteristics
have not been affirmed as GRAS or received previous approval as a
food additive should inadvertently get in to the food supply, the FDA
has procedures in place under existing legal authorities to remove
the contaminated foods from the market.
This was well demonstrated in the U.S. Government response in 2000 to
the appearance of StarLink corn in the food supply, StarLink contains
a pesticidal protein that makes corn resistant to certain types of
insects, and had not been approved for human consumption. At FDA's
urging, corn dry-milling operations began a testing program to screen
all yellow corn intended for human food use. This testing program
remains in effect today, even though the frequency with which the
StarLink gene is being detected has declined significantly. Should
the U.S. government develop a revised testing protocol leading to an
exit strategy for domestic testing as the presence of contaminated
product declines, this will not preclude continued testing of
U.S. Government Assistance in Capacity Building
Because of our extensive experience in evaluating the safety of
genetically engineered foods, FDA and other relevant agencies of the
U.S. Government participate extensively in capacity building programs
to assist other nations in developing appropriate regulatory
frameworks. For example, FDA has conducted joint training sessions
with our colleagues in Canada, Australia, and other countries for
representatives of other governments to teach them about food safety
assessments of genetically engineered foods. Workshops have been
conducted in Moscow for the Russian Federation and neighboring
countries, in Mexico, and just in the past few weeks we conducted a
workshop in Jakarta for ten Southeast Asian countries.
In addition, FDA provides scientific technical assistance in
conjunction with the U.S. Agency for International Development
(USAID), the Dept. of State and the USDA Foreign Agriculture Service
in meetings with health officials from other countries. In October of
this year, the U.S. Government is sponsoring a meeting in New Delhi
on U.S. - India regulatory issues.
FDA also routinely meets and shares U.S. Biotechnology regulatory
processes with foreign regulatory officials who come to the U.S.
In closing, let me just say that FDA, as the federal agency charged
with safeguarding the public health of the U.S. population, is
grateful to the Pontifical Academy of Sciences and the Vatican for
the foresight in recognizing and advocating for the tremendous
potential of genetically engineered food crops to enhance the ability
to feed the hungry of the world, to contribute to improved nutrition
and health of the world population, and to enhance food production
capabilities in developing countries.
Your efforts to convey the facts about genetically engineered foods
to needy countries constitute a real service to humanity. We must
continue to work with the UN World Food Programme and other
International agencies to help equalize the chances for the people of
all nations to have safe and adequate supplies of food in order to
live healthy and productive lives.
The Use of 'Genetically Modified Food Plants' to Combat Hunger in the World
- Study-Document from the Pontifical Academy of Sciences
I. INTRODUCTORY NOTE BY PRESIDENT NICOLA CABIBBO During the closed
session of the Academy held during the Plenary Session many
Academicians expressed deep concern at the distorted way in which
recent scientific results, and in particular those relating to
genetically improved plant varieties, have been presented to the
public. It was decided to establish a committee with the task of
producing a document on this subject. The chairman of the committee
was A. Rich and its other members were W. Arber, T-T. Chang, M.G.K.
Menon, C. Pavan, M.F. Perutz, F. Press, P.H. Raven, and R. Vicuña.
The document was examined by the Council at its meeting of 25
February 2001, submitted to the members of the Academy for their
comments, and then sent to the committee for the preparation of the
final version. The document, which is included in the Proceedings,
expresses the concerns of the scientific community about the
sustainability of present agricultural practices and the certainty
that new techniques will be effective. At the same time, it stresses
the need for the utmost care in the assessment and evaluation of the
consequences of each possible modification, and on this point we
cannot but recall the exhortation of John Paul II regarding
biotechnologies made in his speech of 11 November 2000 on the
occasion of the Jubilee of the Agricultural World: 'they must be
previously subjected to rigorous scientific and ethical control to
ensure that they do not give rise to disasters for the health of man
and the future of the earth'.
The document also expresses concern about excesses with regard to the
establishment of 'intellectual property' rights in relation to widely
used crops - excesses which could be detrimental to the interests of
A further recommendation, clearly stated in the document, is that the
examination of the safety of newly developed cultivars should be
based on well-documented methods and that the methods and results
should be openly discussed and scrutinised by the scientific
community. The Academy will devote an ad hoc meeting to the subject
of genetically modified food plants. This meeting will provide an
opportunity to examine in depth many issues which are raised in the
document and which are of special concern: the methods used in the
testing and licensing of the new cultivars; the comparative risks
associated with different methods of pest control; and the many
scientific, ethical and social issues raised by the introduction of a
new and powerful technology directed towards agricultural improvement.
1. The rapid growth of the world population requires the development
of new technologies to feed people adequately; even now, an eighth of
the world's people go to bed hungry. The genetic modification of food
plants can help meet part of this challenge.
2. Agriculture as it is currently practiced is unsustainable, as is
indicated by the massive losses of topsoil and agricultural land that
have occurred over the past few decades, as well as by the
unacceptable consequences of massive applications of pesticides and
herbicides throughout most of the world. Techniques to genetically
modify crop plants can make important contributions to the solution
of this common problem.
The Potential of Genetically Modified Food Plants
3. Virtually, all food plants have been genetically modified in the
past; such a modification is, therefore, a very common procedure.
4. The cellular machinery of all living organisms is similar, and the
mixing of genetic material from different sources within one organism
has been an important part of the evolutionary process.
5. In recent years, a new technology has been developed for making
more precise and specific improvements in strains of agricultural
plants, involving small, site-directed alterations in the genome
sequence or sometimes the transfer of specific genes from one
organism to another.
6. Genetically modified food plants can play an important role in
improving nutrition and agricultural products, especially in the
Conditions for the Beneficial Use of this New Technology 7. The
scientific community should be responsible for the scientific and
technological research leading to the advances described above, but
it must also monitor the way it is applied and help ensure that it
works to the effective benefit of people.
8. There is nothing intrinsic about genetic modification that would
cause food products to be unsafe. Nevertheless, science and
scientists are - and should further be - employed to test the new
strains of plants to determine whether they are safe for people and
the environment, especially considering that current advances can now
induce more rapid changes than was the case in the past.
9. The methods used for testing the safety of new genetically
modified strains (or more precisely, cultivars) of plants should be
publicly available, as should the results of these tests, in both the
private and public sectors.
10. Governments should have the responsibility for ensuring that the
tests and their results are conducted in line with the highest
criteria of validity. The protocols of evaluation should be made
11. Governments should increase their funding for public research in
agriculture in order to facilitate the development of sustainable and
productive agricultural systems available to everyone.
12. Intellectual property rights should not inhibit a wide access to
beneficial applications of scientific knowledge. In the development
of this modern genetic technology for agriculture, efforts should be
made to facilitate cooperation between the public and private sectors
and to secure the promotion of solidarity between the industrialised
and developing worlds.
13. Special efforts should be made to provide poor farmers in the
developing world with access to improved crop plants and to encourage
and finance research in developing countries. At the same time, means
should be found to create incentives for the production of vegetable
strains suitable to the needs of developing countries.
14. Research to develop such improvements should pay particular
attention to local needs and to the capacity of each country to
engage in a necessary adaptation of its traditions, social heritage,
and administrative practices in order to achieve the success of the
introduction of genetically modified food plants.
Recommendation for the Scientific Community
15. In order to help governments, state-funded researchers, and
private companies to meet the above conditions, and in order to
facilitate the development of common standards and approaches to this
problem in both developing and industrialised countries, the
scientific community, represented by its established worldwide
umbrella organisations, should offer its expertise. A suitably
composed international scientific advisory committee could be
entrusted with this all-important task.
The Pontifical Academy of Sciences has traditionally stressed the
application of science to world food problems. Most recently, the
study week proceedings on "Food Needs of the Developing World in the
Early Twenty- First Century" and "Science for Survival and Social
Development," two conferences held in 1999, emphasized the special
role of modern biotechnology in improving the characteristics of
plants. Here, the members of the Pontifical Academy are considering
newer aspects of these applications in a global context.
The world's people have grown in number from 2.5 billion to more than
6 billion over the past fifty years. One out of four lives in extreme
poverty, and one out of eight is chronically malnourished. These
problems are in part related to patterns of distribution of the
available food, in part to the low productivity of agriculture in
certain regions, including the loss of crops to pests, and in another
part to an unbalanced nutritional value in the daily diet. Enhanced
production of qualitatively improved food under sustainable
conditions could greatly alleviate both poverty and malnutrition.
These are goals that will become even more urgent as our numbers
increase by an estimated two billion additional people over the next
few decades. Modern science can help meet this challenge if it is
applied in an appropriately constructive social and economic context.
Historical Use of GM Plants
Genetically modified (GM) plants can play an important role in
alleviating world food problems. Recent discussions concerning GM
plants have often overlooked the fact that virtually all commonly
used foods have been genetically modified, often extensively, during
the long history of agriculture. Ever since the start of agriculture
about 10,000 years ago, farmers have selected plant variants that
arose spontaneously when they offered increased productivity or other
advantages. Over time, new methods for producing desirable genetic
variants were introduced, and have been used extensively for some two
centuries. Cross-breeding of different plant varieties and species,
followed by the selection of strains with favorable characteristics,
has a long history. That process involves exchanging the genetic
material, DNA, from one organism to another. DNA contains genes, and
genes generally act by expressing proteins; thus the newly modified
plant obtained by genetic crossing usually contains some proteins
that are different from those in the original plant. The classical
method of crossing plants to bring in new genes often results in
bringing in undesirable genes as well as desirable ones since the
process could not be controlled.
New Technology to Develop GM Plants
Almost 30 years ago scientists developed a new technology called
recombinant DNA that made it possible to select the particular gene
that one wanted to transfer to a plant. This process is very specific
and avoids the inclusion of genes that are undesirable. A number of
useful new plant strains have been developed in this way. Even though
such strains are considered to be genetically modified (GM), the same
label could be applied equally appropriately to all strains that have
been modified genetically by human activities -- a process that owes
its success to selection for desirable properties.
We now know a great deal about the DNA in organisms. It contains the
codes for manufacturing different proteins. At the molecular level,
the products of genes, usually proteins, are made from the same
materials in plants, animals and microorganisms. The recent
development of technical means for sequencing the components in DNA
gives us insight into the similarities among organisms. All living
organisms share genes because of their common evolutionary descent.
For example, the sequence of a small worm was completed recently, and
it was found that the worm shares some 7,000 of its estimated 17,000
genes with humans.1 Likewise, the genes found in microorganisms are
often very similar to those found in humans as well as in plants.2
A large number of genes in all placental mammals are essentially the
same, and about a third of the estimated 30,000 genes in humans are
common to plants, so that many genes are shared among all living
organisms. Remarkably, one has discovered another reason for the
similarities between DNA sequences in different organisms: DNA can at
times move in small blocks from one organism to another, a process
that is called lateral transfer. This occurs at a relatively high
rate in microorganisms, and it also occurs in plants and animals,
albeit less frequently. Once this has taken place, the genetic
material that has been transferred becomes an integral part of the
genome of the recipient organism. The recent sequence of the human
genome revealed that over 200 of our estimated 30,000 genes came from
microorganisms,3 demonstrating that such movements are a regular part
of the evolutionary process.
The new technology has changed the way we modify food plants, so that
we can generate improved strains more precisely and efficiently than
was possible earlier. The genes being transferred express proteins
that are natural, not man-made. The changes made alter an
insignificantly small proportion of the total number of genes in the
host plant. For example, one gene may be introduced into a plant that
has 30,000 genes; in contrast, classical cross-breeding methods often
generated very large, unidentified changes in the selected strains.
Many of the statements made here in abbreviated form have been dealt
with more thoroughly in a number of publications. Among the more
significant is a report entitled "Transgenic Plants and World
Agriculture", which was prepared by a committee representing the
academies of sciences of Brazil, China, India, Mexico, the U.K. the
U.S, and the Third World Academy of Sciences. In summary, it reached
the conclusion that foods produced from genetically modified plants
were generally safe, that any new strains needed to be tested and
that further investigation of the potential ecological problems
associated with such new strains also needed further consideration.
The French Academy of Science also issued a very useful report,
commenting on many aspects of this issue and dealing especially with
the problems of deployment of GM plants in developing countries. The
accumulating literature in this field has become quite extensive.
Traditional methods have been used to produce plants that manufacture
their own pesticides, and thus are protected from pests or diseases.
They have also been employed to produce herbicide-resistant plants.
When such plants are grown, specific herbicides are used to
efficiently control the weeds growing among them without harming the
basic crop. Another goal of traditional agriculture has been the
nutritional enhancement of foods, either in terms of amino acid
balance or in enhancing the presence of vitamins or their precursors.
All of these goals can be attained more efficiently and precisely
with the use of methods that are now available involving the direct
transfer of genes. Newer goals, mostly unattainable earlier, include
the development of plant strains that can manufacture desired
substances, including vaccines or other drugs.
How to Make Sure GM Plant Products are Safe These goals are highly
desirable, but the questions that have arisen often concern the
method of genetic modification itself, not its products. The
appearance of these products has generated a legitimate desire to
evaluate carefully their safety for consumption by human beings and
animals, as well as their potential effects on the environment. As is
usual for complicated questions, there are no simple answers, and
many elements need careful consideration.
Contrary to common perception, there is nothing intrinsic to the
genetic modification of plants that causes products derived from them
to be unsafe. The products of gene alteration, just like the products
of any modification, need to be considered in their own right and
individually tested to see if they are safe or not. The public needs
to have free access to the methods and results of such tests, which
should be conducted not only by companies that develop the
genetically altered plants, but also by governments and other
disinterested parties. Overall, widely accepted testing protocols
need to be developed in such a way that their results can be
understood and can be used as a basis for consumer information.
One of the present concerns is that new genetically modified plants
may include allergens that will make them unhealthy for some people.
It is possible to test these plants to determine whether they have
allergens. Many of our present foodstuffs, such as peanuts or
shellfish, have such allergens, and they represent a public health
hazard to that part of the population with corresponding allergies.
It is important that any genetically modified crop varieties, as well
as others produced by traditional breeding methods, be tested for
safety before they are introduced into the food supply. In this
connection, we also note that the new technologies offer ready
methods for removing genes associated with allergens, both in present
crops and newly produced ones.
Another issue concerns the potential impact of genetically modified
plants on the environment. Cultivated plants regularly hybridize with
their wild and weedy relatives, and the exchange of genes between
them is an important factor in plant evolution. When crops are grown
near relatives with which they can produce fertile hybrids, as in the
case of maize and its wild progenitor teosinte in Mexico and Central
America, genes from the crops can spread to the wild populations.
When this occurs, the effects of these genes on the performance of
the weeds or wild plants needs to be evaluated. There is nothing
wrong or unnatural about the movement of genes between plant species.
However, the effects of such movement on the characteristics of each
plant species may vary greatly. There are no general reasons why we
should fear such gene introductions, but in each case, scientific
evaluation is needed. The results should be verified by the
appropriate government agency or agencies, and full disclosure of the
results of this process should be made to the public.
There are many opportunities to use this new technology to improve
not only the quantity of food produced but also its quality. This is
illustrated most clearly in the recent development of what is called
"golden rice",4 a genetically modified rice that has incorporated in
it the genes needed to create a precursor of Vitamin A. Vitamin A
deficiency affects 400 million people,5 and it often leads to
blindness and increased disease susceptibility. Use of this modified
rice and strains developed with similar technologies will ultimately
make it possible to help overcome Vitamin A deficiency. "Golden rice"
was developed by European scientists, funded largely by the
Rockefeller Foundation and using some methods developed by a private
company. However, that company has agreed to make the patents used in
the production of this strain freely available to users throughout
When successfully bred into various local rice strains and expressed
at high enough levels, it offers the possibility of helping to
alleviate an important nutritional deficiency. This is just one of
several plant modifications that has the potential for producing
More Government-sponsored Research is Needed Research involving the
use of recombinant DNA technology to develop genetically modified
plants is carried out worldwide. It involves government laboratories,
independent institutes and private corporations. During the period
following World War II, most international crop research was funded
by the public sector and through charitable foundations. This led to
a spectacular doubling or tripling of crop yields in large parts of
Asia and Latin America. This "Green Revolution" met the needs of
millions of poor farmers and consumers and alleviated starvation for
tens of millions of people. The revolution was a consequence of the
production of "dwarf" wheat and rice plants by the introduction of
genes from dwarf varieties into high-yielding strains of grain.
Substantial public sector agricultural research still exists in North
America, Australia, Europe, China, India, Brazil and in the
Consultative Group for International Agricultural Research which
comprises 16 international research centers.
decades, however, public funding for agricultural research has
dwindled, while funding from corporations has increased markedly.
Governments should recognize that there is an important public
interest element in this research, even in market-driven economies.
Public contributions are important because the results of such
research work are made available to everyone. At the same time it
makes possible various opportunities for public and private
collaboration, so that the benefits of the new technologies for
genetic modification are brought to all of the people throughout the
world. It is also important that such research not be inhibited by
overprotective intellectual property measures.
Special Needs of Poor Farmers
A significant distinction must be made between the use of genetically
modified plants in the developed world and their use in the
developing world. In the developed world, farmers can often afford to
pay for expensive seeds that yield disease-resistant crops that
require lower levels of pesticides or that produce more food per
hectare. This is also true for many farmers in the developing world.
For poor farmers in the developing world, however, governments must
intervene if they are to be able to obtain the benefits of modern
crop improvement technology. Several private corporations engaged in
agricultural research have indicated their willingness to make
available the results of their research without charge for use in
developing countries. Their willingness should be recognized and
In this connection, we endorse the recommendation of the
seven-academy group mentioned above that an international advisory
committee should be established to assess the implications of
genetically modified plants, especially in developing countries. The
committee would identify areas of common interest and opportunity
between institutions in the private and public sectors. This could be
one way of assuring that the benefits of these new technologies are
made widely available. Intellectual property issues are of special
importance in this context. We recommend that this committee
participate in the development of generally accepted standards for
testing and approval of new plant strains and the foods derived from
them, a development of great importance for world commerce.
The Crisis in Agriculture
The loss of a quarter of the world's topsoil over the past fifty
years, coupled with the loss of a fifth of the agricultural land that
was cultivated in 1950,6 indicates clearly that contemporary
agriculture is not sustainable. To become sustainable, agriculture
will need to adopt new methods suitable for particular situations
around the world. These include greatly improved management of
fertilizers and other chemical applications to crops, integrated pest
management to include improved maintenance of populations of
beneficial insects and birds to control pests, and the careful
management of the world's water resources. (Human beings currently
use 55% of the renewable supplies of fresh water, mostly for
agriculture.) It will also be necessary to develop strains of crop
plants with improved characteristics to make them suitable for use in
the many diverse biological, environmental, cultural and economic
areas of the world.
Genetically modified plants can be an important component of efforts
to improve yields on farms otherwise marginal because of limiting
conditions such as water shortages, poor soil, and plant pests. To
realize these benefits, however, the advantages of this rapidly
growing technology must be explained clearly to the public throughout
the world. Also, results of the appropriate tests and verifications
should be presented to the public in a transparent, easily understood
An estimated 85 million birds and billions of insects7 are killed
annually in the United States alone, as a result of the application
of pesticides on crops. Some 130,000 people become ill in this
connection each year. Genetically modified plants currently in use
have already greatly reduced the use of such chemicals, with great
ecological benefits. It is expected that such benefits will be
significantly enhanced as research and development efforts continue.
Hope for the Future
Finally, it is important that scientists make an effort to clearly
explain to the public the issues concerning risk. All technological
developments have elements of risk, whether we refer to the
introduction of vaccines, new forms of therapy, new types of
foodstuffs or new pesticides. Risk cannot be avoided, but it can be
minimized. The long-term aim is to develop plants that can produce
larger yields of healthier food under sustainable conditions with an
acceptable level of risk. The latter can be determined by scientific
studies, with the results made freely available to the public.
The developments we have discussed here constitute an important part
of human innovation, and they clearly offer substantial benefits for
the improvement of the human condition worldwide. They are essential
elements in the development of sustainable agricultural systems
capable of feeding not only the eighth of the world's population that
is now hungry, but also meeting the future needs of the growing world
population. To make the best use of these new technologies and the
agricultural management opportunities they create is a moral
challenge for scientists and governments throughout the world.
1 The C. elegans Sequencing Consortium, 1998. 'Genome Sequence of the
Nematode C. elegans: A Platform for Investigating Biology'. Science
2 The Arabidopsis Genome Initiative. 2000. Analysis of the Genome
Sequence of the Flowering Plant Arabidopsis thaliana. Nature
3 Venter, J. Craig et al. 2001. 'The Sequence of the Human Genome'.
4 Potrykus, Ingo. 2001. 'Golden Rice and Beyond'. Plant Physiology
5 Ye, Xudong et al. 2000. 'Engineering the Provitamin A (_-Carotene)
Biosynthetic Pathway into (Carotenoid-Free) Rice Endosperm'. Science
6 Norse, D. et al. 1992. 'Agriculture, Land Use and Degradation'. pp.
79-89. In Dooge, J.C.I. et al. (eds.). An Agenda of Science for
Environment and Development into the 21st Century. Cambridge
University Press, Cambridge.
7 Pimentel, D. et al. 1992. 'Environmental and Economic Costs of
Pesticide Use'. BioScience 42: 750-59.