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Date:

February 10, 2004

Subject:

Biotech and Africa; Saving Billions; Invisible Wealth; APEX Panel

 

Today in AgBioView: February 11, 2004

* Is Africa "caught up" in the biotech debate?
* Technology That Will Save Billions From Starvation
* Africa: Time to Focus on Invisible Wealth
* ENVIRONMENTAL IMPACT OF GM HERBICIDE-TOLERANT CROPS: THE UK FARM SCALE
EVALUATIONS AND PROPOSAL FOR MITIGATION
* Apex panel on GMOs getting its act together
* How Much Should We Worry about Biotech?
* APHIS SOLICITS PUBLIC COMMENT ON PROPOSED GENETICALLY ENGINEERED
ORGANISM ENVIRONMENTAL IMPACT STATEMENT

Date: Tue, 10 Feb 2004 20:21:16 -0500
From: "TAWANDA ZIDENGA"
Subject: Is Africa "caught up" in the biotech debate?

I have read articles before, and they keep pouring in, about how Africa is
"caught up" in the biotech debate, mainly between Europe and America.
Analogues have been drawn on how the grass suffers when two elephants
fight. Issues of trade in Europe have been offered as practical
complications of the African decision on GMOs. I have attended countless
debates on GMOs back in Zimbabwe, most of them themed on the "miracle or
menace" philosophy on gene technology.

I think it is this extremist fashion that has damaged an otherwise healthy
debate on a scientific matter. First I do not think we are caught up in
the biotech debate. I think we are caught up in the victim mentality! It
is that mentality which robs us from viewing this technology in
perspective.

Biotechnology is neither a miracle nor a menace. It is simply a
technology, and how we decide to use it will determine whether it will
lift us up, destroy us or simply help us along. I think that debates in
Africa, assuming they are still necessary, should focus on what aspects of
biotechnology we can work on to solve our pertinent problems of health and
food. That Africa needs the technology should by now be a forgone
conclusion. The whole world needs it, and the only time we should
regionalise the discussion is when we are considering priorities. We need
to look ahead.
********************************

http://www.agbioworld.org/biotech_info/articles/prakash/prakashart/save-billions.html


Technology That Will Save Billions From Starvation

- The American Enterprise, By C.S. Prakash and Gregory Conko, March 01,
2004

Today, most people around the world have access to a greater variety of
nutritious and affordable foods than ever before, thanks mainly to
developments in agricultural science and technology. The average human
life span--arguably the most important indicator of quality of life--has
increased steadily in the past century in almost every country. Even in
many less developed countries, life spans have doubled over the past few
decades. Despite massive population growth, from 3 billion to more than 6
billion people since 1950, the global malnutrition rate decreased in that
period from 38 percent to 18 percent. India and China, two of the world's
most populous and rapidly industrializing countries, have quadrupled their
grain production.

The record of agricultural progress during the past century speaks for
itself. Countries that embraced superior agricultural technologies have
brought unprecedented prosperity to their people, made food vastly more
affordable and abundant, helped stabilize farm yields, and reduced the
destruction of wild lands. The productivity gains from G.M. crops, as well
as improved use of synthetic fertilizers and pesticides, allowed the
world's farmers to double global food output during the last 50 years, on
roughly the same amount of land, at a time when global population rose
more than 80 percent. Without these improvements in plant and animal
genetics and other scientific developments, known as the Green Revolution,
we would today be farming on every square inch of arable land to produce
the same amount of food, destroying hundreds of millions of acres of
pristine wilderness in the process.

Many less developed countries in Latin America and Asia benefited
tremendously from the Green Revolution. But due to a variety of reasons,
both natural and human, agricultural technologies were not spread equally
across the globe. Many people in sub-Saharan Africa and parts of South
Asia continue to suffer from abject rural poverty driven by poor farm
productivity. Some 740 million people go to bed daily on an empty stomach,
and nearly 40,000 people--half of them children--die every day of
starvation or malnutrition. Unless trends change soon, the number of
undernourished could well surpass 1 billion by 2020.

The U.N. Food and Agriculture Organization (FAO) expects the world's
population to grow to more than 8 billion by 2030. The FAO projects that
global food production must increase by 60 percent to accommodate the
estimated population growth, close nutrition gaps, and allow for dietary
changes over the next three decades. Food charity alone simply cannot
eradicate hunger. Increased supply--with the help of tools like
bioengineering --is crucial.

Although better farm machinery and development of fertilizers,
fertilizers, insecticides, and herbicides have been extremely useful, an
improved understanding of genetic principles has been the most important
factor in improving food production. Every crop is a product of repeated
genetic editing by humans over the past few millennia. Our ancestors chose
a few once-wild plants and gradually modified them simply by selecting
those with the largest, tastiest, or most robust offspring for
propagation. Organisms have been altered over the millennia so greatly
that traits present in existing populations of cultivated rice, wheat,
corn, soy, potatoes, tomatoes and many others, have very little in common
with their ancestors. Wild tomatoes and potatoes contain very potent
toxins, for example. Today's cultivated varieties have been modified to
produce healthy and nutritious food.

Hybridization, the mating of different plants of the same species, has
helped us assimilate desirable traits from several varieties into elite
specimens. And when desired characteristics were unavailable in cultivated
plants, genes were liberally borrowed from wild relatives and introduced
into crop varieties, often of different but related species. Wheat, rye,
and barley are regularly mated with wild grass species to introduce new
traits. Commercial tomato plants are commonly bred with wild tomatoes to
introduce improved resistance to pathogens, nematodes, and fungi.
Successive generations then have to be carefully backcrossed into the
commercial cultivars to eliminate any unwanted traits accidentally
transferred from the wild plants, such as toxins common in the wild
species.

Even when crop and wild varieties refuse to mate, various tricks can be
used to produce "wide crosses" between two plants that are otherwise
sexually incompatible. Often, though, the embryos created by wide crosses
die before they mature, so they must be "rescued" and cultured in a
laboratory. Even then, the rescued embryos typically produce sterile
offspring. They can only be made fertile again by using chemicals that
cause the plants to mutate and produce a duplicate set of chromosomes. The
plant triticale, an artificial hybrid of wheat and rye, is one such
example of a wide-cross hybrid made possible solely by the existence of
embryo rescue and chromosome doubling techniques. Triticale is now grown
on over 3 million acres worldwide, and dozens of other products of
wide-cross hybridization are common.

When a desired trait cannot be found within the existing gene pool,
breeders can create new variants by intentionally mutating plants with
radiation, with chemicals, or simply by culturing clumps of cells in a
Petri dish and leaving them to mutate spontaneously during cell division.
Mutation breeding has been in common use since the 1950s, and more than
2,250 known mutant varieties have been bred in at least 50 countries,
including France, Germany, Italy, the United Kingdom, and the United
States. A relatively new mutant wheat variety, made to be resistant to a
commercial herbicide, was put on the market in the U.S. as recently as
July 2003.

Recombinant DNA (rDNA) methods are a recent extension of the myriad
techniques that have been employed to modify and improve crops. The
primary difference is that modern bioengineered crops involve a precise
transfer of one or two known genes into plant DNA--a surgical alteration
of a tiny part of the crop's genome compared to the traditional
sledgehammer approaches, which bring about gross genetic changes, many of
which are unknown and unpredictable.

Leading scientists around the world have attested to the health and
environmental safety of agricultural biotechnology, and they have called
for bioengineered crops to be extended to those who need them most--hungry
people in the developing world. Dozens of scientific and health
associations, including the U.S. National Academy of Sciences, the
American Medical Association, the U.K.'s Royal Society, and the United
Nations Development Programme, have endorsed the technology. Nearly 3,500
eminent scientists from all around the world, including 24 Nobel
laureates, have signed a declaration supporting the use of agricultural
biotechnology. And a review of 81 separate research projects conducted
over 15 years--all funded by the European Union--found that bioengineered
crops and foods are at least as safe for the environment and for human
consumption as conventional crops, and in some cases even safer.

Crops enhanced through modern biotechnology are now grown on nearly 143
million acres in 16 countries. More important, more than three quarters of
the 5.5 million growers who benefit from bioengineered crops are
resource-poor farmers in the developing world. Unremarkably, most
commercially available biotech plants were designed for farmers in the
industrialized world. They include varieties of corn, soybean, potato, and
cotton modified to resist insect pests, plant diseases, and to make weed
control easier. However, the increasing adoption of bioengineered
varieties by farmers in developing countries over the past few years has
shown that they can benefit at least as much as, if not more than, their
industrialized counterparts. The productivity of farmers everywhere is
limited by crop pests and diseases --and these are often far worse in
tropical and subtropical regions than the temperate zones.

About 20 percent of plant productivity in the industrialized world, and up
to 40 percent in Africa and Asia, is lost to insects and pathogens,
despite the ongoing use of copious amounts of pesticides. The European
corn borer destroys approximately 7 percent, or 40 million tons, of the
world's corn crop each year-- equivalent to the annual food supply for 60
million people. So it comes as no surprise that, when they are permitted
to grow bioengineered varieties, poor farmers in less developed nations
have eagerly snapped them up. According to the International Service for
the Acquisition of Agri-Biotech Applications, farmers in less developed
countries now grow nearly one quarter of the world's bioengineered crops
on more than 26 million acres.

Bioengineered plants have also had other important benefits for farmers in
less developed countries. In China, where pesticides are typically sprayed
on crops by hand, some 400 to 500 cotton farmers die every year from acute
pesticide poisoning. Researchers at Rutgers University and the Chinese
Academy of Sciences found that using bioengineered cotton in China has
lowered the amount of pesticides by more than 75 percent and reduced the
number of pesticide poisonings by an equivalent amount. Another study by
economists at the University of Reading in Britain found that South
African cotton farmers have seen similar benefits.

The reduction in pesticide spraying also means that fewer natural
resources are consumed to manufacture and transport the chemicals. In 2000
alone, U.S. farmers growing bioengineered cotton used 2.4 million fewer
gallons of fuel and 93 million fewer gallons of water, and were spared
some 41,000 ten hour days needed to apply pesticide.

Soon, many bioengineered varieties that have been created specifically for
use in underdeveloped countries will be ready for commercialization.
Examples include insect resistant rice for Asia, virus-resistant sweet
potato for Africa, and virus-resistant papaya for Caribbean nations. The
next generation of bioengineered crops now in research labs around the
world is poised to bring even further improvements for the poor soils and
harsh climates that are characteristic of impoverished regions. Scientists
have already identified genes resistant to environmental stresses common
in tropical nations, including tolerance to soils with high salinity and
to those that are particularly acidic or alkaline.

The primary reason why Africa never benefited from the Green Revolution is
that plant breeders focused on improving crops such as rice, wheat, and
corn, which are not widely grown in Africa. Also, much of the African dry
lands have little rainfall and no potential for irrigation, both of which
played essential roles in the success stories for crops such as Asian
rice. Furthermore, the remoteness of many African villages and the poor
transportation infrastructure in landlocked African countries make it
difficult for African farmers to obtain agricultural chemical inputs such
as fertilizers, insecticides, and herbicides--even if they could be
donated by charities, or if they had the money to purchase them. But, by
packaging technological inputs within seeds, biotechnology can provide the
same, or better, productivity advantage as chemical or mechanical inputs,
and in a much more user-friendly manner. Farmers would be able to control
insects, viral or bacterial pathogens, extremes of heat or drought, and
poor soil quality, just by planting these crops.

Still, anti-biotechnology activists like Vandana Shiva of the New
Delhi-based Research Foundation for Science, Technology and Ecology, and
Miguel Altieri of the University of California at Berkeley, argue that
poor farmers in less developed nations will never benefit from
biotechnology because it is controlled by multinational corporations.
According to Altieri, "Most innovations in agricultural biotechnology have
been profit-driven rather than need-driven. The real thrust of the genetic
engineering industry is not to make Third World agriculture more
productive, but rather to generate profits."

That sentiment is not shared by the thousands of academic and public
sector researchers actually working on biotech applications in those
countries. Cyrus Ndiritu, former director of the Kenyan Agricultural
Research Institute, argues, "It is not the multinationals that have a
stranglehold on Africa. It is hunger, poverty and deprivation. And if
Africa is going to get out of that, it has got to embrace" biotechnology.

Biotechnology also offers hope of improving the nutritional benefits of
many foods. The next generation of bioengineered products now in
development is poised to bring direct health benefits to consumers through
enhanced nutritive qualities that include more and higher-quality protein,
lower levels of saturated fat, increased vitamins and minerals, and many
others. Bioengineering can also reduce the level of natural toxins (such
as in cassava and kidney beans) and eliminate certain allergens from foods
like peanuts, wheat, and milk. Many of these products are being developed
primarily or even exclusively for subsistence farmers and consumers in
poor countries.

Among the most well known is Golden Rice--genetically enhanced with added
beta carotene, which is converted to Vitamin A in the human body. Another
variety developed by the same research team has elevated levels of
digestible iron. The diet of more than 3 billion people worldwide includes
inadequate levels of essential vitamins and minerals, such as Vitamin A
and iron. Deficiency in just these two micronutrients can result in severe
anemia, impaired intellectual development, blindness, and even death. Even
though charities and aid agencies such as the United Nations Children's
Fund and the World Health Organization have made important strides in
reducing Vitamin A and iron deficiency, success has been fleeting. No
permanent effective strategy has yet been devised, but Golden Rice may
finally provide one.

The Golden Rice project is a prime example of the value of extensive
public sector and charitable research. The rice's development was funded
mainly by the New York-based Rockefeller Foundation, which has promised to
make the rice available to poor farmers at little or no cost. Scientists
at public universities in Switzerland and Germany created it with
assistance from the Philippines-based International Rice Research
Institute and from several multinational corporations. Scientists at
publicly funded, charitable, and corporate research centers are developing
many other similar crops. Indian scientists, for example, have recently
announced that they would soon make a new high-protein potato variety
available for commercial cultivation.

Research is already under way on fruits and vegetables that could one day
deliver life-saving vaccines--such as a banana with the vaccine for
Hepatitis B, and a potato that provides immunization against diarrheal
diseases.

It is true that certain aspects of modern farming have had a negative
impact on biodiversity and on air, soil, and water quality. But
biotechnology has proven safer for the environment than anything since the
invention of the plow. The risk of cross-pollination from crops to wild
relatives has always existed, and such "gene flow" occurs whenever crops
grow in close proximity to sexually compatible wild relatives. Yet,
breeders have continuously introduced genes for disease and pest
resistance through conventional breeding into all of our crops. Traits,
such as stress tolerance and herbicide resistance, have also been
introduced in some crops with conventional techniques, and the growth
habits of every crop have been altered. Thus, not only is gene
modification a common phenomenon, but so are many of the specific kinds of
changes made with rDNA techniques.

Naturally, with both conventional and rDNA-enhanced breeding, we must be
vigilant to ensure that newly introduced plants do not become invasive and
that weeds do not become noxious because of genetic modification.
Similarly, we must ensure that target genes are safe for human and animal
consumption before they are transferred. But, while modern genetic
modification expands the range of new traits that can be added to crop
plants, it also ensures that more will be known about those traits and
that the behavior of the modified plants will be, in many ways, easier to
predict.

The biggest threats that hungry populations currently face are restrictive
policies stemming from unwarranted public fears. Although most Americans
tend to support agricultural biotechnology, many Europeans and Asians have
been far more cautious. Anti-biotechnology campaigners in both
industrialized and less developed nations are feeding this ambivalence
with scare stories that have led to the adoption of restrictive policies.
Those fears are simply not supported by the scores of peer reviewed
scientific reports or the data from tens of thousands of individual field
trials.

In the end, over-cautious rules result in hyper-inflated research and
development costs and make it harder for poorer countries to share in the
benefits of biotechnology. No one argues that we should not proceed with
caution, but needless restrictions on agricultural biotechnology could
dramatically slow the pace of progress and keep important advances out of
the hands of people who need them. This is the tragic side effect of
unwarranted concern.

In 2002, Zambian President Levy Mwanawasa rejected some 23,000 metric tons
of food aid in the midst of a two-year-long drought that threatened the
lives of over 2 million Zambians. President Mwanawasa's public explanation
was that the bioengineered corn from the United States was "poisonous."
Other Zambian government officials conceded that the bigger concern was
for future corn exports to the European Union, which observes a moratorium
on new G.M. foods.

Zambia is not unique. European biotechnology restrictions have had other,
similar consequences throughout the developing world. Thai government
officials have been reluctant to authorize any bioengineered rice
varieties, even though it has spent heavily on biotechnology research.
Uganda has stopped research on bioengineered bananas and postponed their
introduction indefinitely. Argentina has limited its approvals to the two
bioengineered crop varieties that are already permitted in European
markets.

Even China, which has spent hundreds of millions of dollars funding
advanced biotechnology research, has refused to authorize any new
bioengineered food crops since the European Union's moratorium on
bioengineered crop approvals began in 1998. More recently, the
International Rice Research Institute, which has been assigned the task of
field-testing Golden Rice, has indefinitely postponed its plans for
environmental release in the Philippines, fearing backlash from
European-funded NGO protestors. Still, the E.U. moratorium continues to
persist after five long years, despite copious evidence, including from
the E.U.'s own researchers, that biotech modification does not pose any
risks that aren't also present in other crop-breeding methods.

Of course, hunger and malnutrition are not solely caused by a shortage of
food. The primary causes of hunger in some countries have been political
unrest and corrupt governments, poor transportation and infrastructure
and, of course, poverty. All of these problems must be addressed if we are
to ensure real, worldwide food security.

But during the next 50 years, the global population is expected to rise by
50 percent--to 9 billion people, almost entirely in the poorest regions of
the world. And producing enough to feed these people will require the use
of the invaluable gift of biotechnology.
***********************************************

http://www.africabiotech.com/news2/article.php?uid=59

Africa: Time to Focus on Invisible Wealth

- Inter Region Economic Network, By James Shikwati, February 11, 2004

Albert Einstein once stated: "Imagination is more important than
knowledge." Intellectual Property Rights are often considered as serious
obstacles to trade and the transfer of technologies related to the
conservation of biological diversity. African countries are rich in
biodiversity and indigenous knowledge which has flowed freely to the
developed countries. However global market trends are such that Africa
must urgently address issues pertaining property rights if they have to
fit into the global economy and also stimulate inventions and innovations.
The challenge facing Africa is how to produce high quality goods and
services while at the same time tackling aspects of poverty and
unemployment. Africa is seen to participate in IPR as late comers already
faced with other priority issues and lacking capacity to enforce IPR
regimes.

In the book "How Europe Underdeveloped Africa", Walter Rodney argues that
the Western World engaged in atrocities and looting of the African
continent making people desperately poor. 50 years after most African
countries gained independence from Europe, the Africans are still queuing
for donor funding investing less in homegrown solutions and African
talent. The biggest question is why this is happening in Africa, where
people are endowed with the human mind that is creative and innovative?

The developed/Western countries did not get wealthy by merely exploiting
the Third World. Dennis T. Avery in his paper "Sustaining Both Planet and
People" argues that what the West did to get rich was to invent the
systematic search for knowledge and then share it broadly. The West have
always sought systematic knowledge that can be replicated and refer to
that knowledge as "science". It is for this reason that they have moved
from focusing on natural resources such as "land" to resources such as
transistors, radios, fiber optic cables from sand. Most third world
countries on the other hand have focused only on the "visible wealth" and
'tribal organization'. This structure instead of fostering wealth,
promotes war over resources.

The list of inventions and innovations rarely indicates participation from
Africa, falsely creating an impression that Africans are not creative and
innovative. On the contrary however, long before the colonialist came to
Africa, the African people had started ventures in medicine, iron
smelting, arts, music, house building, and bead making and curving. The
power of innovation was also exhibited in the way they preserved fire for
later use, stored foodstuffs and the very fact that they could light a
fire by rubbing two sticks together.

However the lack of systematic recording and beyond a collective level of
property right recognition, robbed many innovators in Africa the ability
to have their ideas improved upon and made economically viable. More so,
the lack of a property rights regime that could measure to the countries
that later colonized Africa made it easier for both physical and
intellectual property to be seized by the occupying powers. Keeping
knowledge secret as did metallurgists and medicine men in Africa without
proper records robbed this continent of knowledge that would presently
solve some of the ailments afflicting the continent.

Intellectual Property rights is the term that describes ideas, inventions,
technologies, artworks, music and literature that are intangible when
first created, but become valuable in tangible forms as products. IP is
the commercial application of imaginative thought to solving a technical
or artistic challenge. It is not a product itself, but the special idea
behind it, the way the idea is expressed, and the distinctive way it is
named and described. Africa is plagued by many problems ranging from
social to economic that urgently indicate the presence of a unique market
opportunity to innovators. Innovations may not necessarily be triggered by
Intellectual Property Rights regime but also by the demand for solutions.
It is therefore strategic for Africans to develop a quest within
themselves to solve their own problems as a step to reaping benefits from
IPR.

Some of the areas IPR can be used include the health sector, agricultural
sector and the arts. For instance, Malaria was identified as the primary
cause of poverty that slows down economic growth in Africa by 1.3%. The
former Kenya's Health Minister Professor Sam Ongeri estimated that 17
million days at work place are lost every year due to malaria. It
estimated that Kenya spends $10.4 Million every year to control malaria.

Intellectual Property ownership becomes a strategic tool for Africans to
tackle diseases of poverty given the fact that wealthy nations may spend
less time on diseases that don't affect them. To stem the tide of HIV-AIDS
and Malaria in Africa, proper incentives for innovators must be put in
place in order to save more Africans from dying. Intellectual property
rights protection does not stop philanthropists and other people who might
want to assist the poor from doing so. It simply meant to provide an
avenue that will promote creativity and rewards to innovators.

Intellectuals from Africa migrate to wealthy countries in search for more
rewarding challenges, better pay and recognition. This has been possible
due to lack of an effective intellectual property regime that will make
them stay home and help their countries create wealth. More often than
not, they are harassed and treated with suspicion for merely being
intellectuals. To stem brain drain, it's instructive that Africa builds
institutions that will protect intellectual property. Building such
institutions will ensure that the African innovators build upon the
already existing knowledge to solve Africa's problems. Africa has become a
mining ground for intellectual property with many researchers focusing on
the biosphere and culture, without promoting systems that protect
property, chances of abuse can be high.

In the field of agriculture, intellectual property regime will spur
activity among the scientists and farmers to facilitate new knowledge that
will lead to innovations. Such innovations will save Africa from relying
on "climate fed" agriculture to intelligently driven agricultural
practices. Releasing agro based population will enhance other areas of the
economy such as the tourism industry, the retail industry and other
technologically oriented industries. This can also make Africa to
effectively join the biotech industry and save her populations from
malnutrition and hunger.

Developed countries have been known to use protection of property rights
as a barrier to trade especially in the field of medicine and arts. Third
world countries ought to enforce intellectual property protection for its
own good while at the same time allowing more innovators to compete in
their own countries in order facilitate affordable prices.

What belongs to everyone, belongs to no one, and hence falls into
disrepair. Africa must urgently seize this opportunity of protecting
intellectual property not only in order to protect her own and make her
people more innovative and provide solutions to African problems, but also
to attract more investment and exchange of goods from other countries.

Intellectual Property Rights is a useful tool in maintaining the
innovation process much needed to make Africa industrious. It's only
through Intellectual Property that Africa will move from focusing only on
the "visible wealth" to the invisible. This will not only improve the
economies, give more avenues for investment but also reduce conflicts in
the continent.

--

James Shikwati is the Director of the Inter Region Economic Network and
Africa Resource Bank Coordinator.
*****************************************

http://www.isb.vt.edu/news/2004/news04.feb.html#feb0402

ENVIRONMENTAL IMPACT OF GM HERBICIDE-TOLERANT CROPS: THE UK FARM SCALE
EVALUATIONS AND PROPOSAL FOR MITIGATION

- Alan M. Dewar, Mike J. May and John D. Pidgeon

In October this year, the long-awaited results of the UK Farmscale
Evaluations (FSE) of the environmental impact of GM herbicide-tolerant
(GMHT) crops were published in the prestigious journal, Philosophical
Transactions of the Royal Society. In the ensuing media frenzy, the
headlines suggested that beet and spring-sown oilseed rape (canola) were
harmful and maize less harmful to the environment compared to their
conventional equivalents. To the environmentalist, the label `harmful' is
based on the premise that fewer weeds lead to fewer weed seeds, the
decline of which would provide less food for birds and other wildlife
within the crops, and less seed return to the seedbank. To the farmers,
the initial outcome of this could be described as beneficial. In essence
the study concluded that the already depleted arable ecosystem (compared
to an undisturbed environment) would be further depleted by the use of
GMHT technology because these 'break crops' are regarded as having a
restorative function for the seed bank in a normal rotation. That is, weed
control within conventional varieties of beet and oilseed rape is
relatively poor, and this allows the in-field plant species to replenish
their seed stocks with consequent benefits for the dependent food chain.
Environmental organizations such as English Nature and the Royal Society
for the Protection of Birds (RSPB) raised major concerns about the
long-term impact of these GMHT crops on wildlife in general, and birds in
particular. These concerns were raised against the background of declining
populations of both weed seeds, especially of broad-leaved plants (circa
3% per annum) and several species of farmland birds (up to 60% decline in
some species since 1970), though other species have shown no decline or
even gain.

Effects on Plants

To some extent, the results of the FSE reinforce these concerns. As used
in the trials, the herbicides applied to GMHT beet (glyphosate: Roundup
Biactive from Monsanto) and spring sown oilseed rape (glufosinate
ammonium: Liberty from Bayer CropScience) did give better weed control
than the conventional herbicides used on the non-GM crops, and this did
lead to lower weed biomass at the end of the season, and fewer weed seeds
being caught in seed rain traps. There were also fewer seeds in the seed
bank in the following year in the next crop (mostly cereals) in the
rotation1,2. In maize the opposite was true. Glufosinate applied to the GM
variety gave poorer control of weeds than the conventional regimes, which,
in 75% of the test crops, were based on atrazine applied mostly
pre-emergence. As atrazine is a persistent, relatively broad spectrum
residual herbicide, it is not surprising that it gave better control than
one that was applied some time after the crop and weeds had emerged.
Indeed, conventional maize crops had the fewest weeds, lowest weed
biomass, and produced fewest weed seeds of all the crops tested. The
recent announcement within the European Union that atrazine would be
banned in the near future has cast doubt on the validity of the maize
results; however, as this intention was not known at the time the
experiment was devised, the results remain valid for the comparisons that
were made. Further work may need to be done to re-examine the comparison
when farmers have selected alternative conventional products in a couple
years time, after the ban has been implemented.

Effects on Invertebrates

Although the results as far as plant survival is concerned are fairly
clear cut, the effects of the two treatments on invertebrates were less
clear. For the majority of organisms measured, including carabid and
staphylinid beetles, spiders, slugs, snails, true bugs, pests, and
predators, there was no difference between the conventional and GMHT
crops3, 4. Within some of those groups, a few species that rely heavily on
the weeds for food or habitat did respond to the differences in weed and
seed abundance. For example there were more seed-eating carabid beetles
(Harpalus rufipes) in conventional beet and oilseed rape and GMHT maize in
July and/or August when more seeds were available; in contrast there were
more detritivorous springtails (Collembola) in all three GMHT crops later
in the season because there was more decaying plant material to feed on
following the later control of large weeds in these fields. This in turn
led to more springtail-feeding carabid beetles (Loricera pilicornis) in
the GMHT crops3.

The results that contributed most to the headlines in the national and
international press, however, concerned butterflies and bees. Bees were
significantly reduced in GMHT beet, but not in the other two crops,
largely because of the good control of thistles by glyphosate4 compared to
conventional herbicides. However, the number of bees recorded in
conventional beet was very low compared to the number seen in rape crops
(2.26 compared to 36.9 per km of transect), so the importance of this
statistic is questionable. The picture is similar for butterflies.
Although there were significantly fewer butterflies both within and around
GMHT beet and oilseed rape crops, the numbers in the former were much
less4,5. Beet is not a favored crop for these aerial insects unless fields
are infested with thistles and other flowering plants. Of the butterfly
species affected in oilseed rape, more than half were pest species
(Pieris). So again, the significance of these results on non-pest species
depends on the availability of other food sources within the farmed
landscape and is certainly not as draconian as suggested by the headlines.

Implications for Farm Management

In contrast to the perceived harmful effects, there were some considerable
benefits in terms of farm management to be gained from using the GMHT
technology. The number of spray applications made to the GMHT crops, and
therefore also the amount of energy used to apply them, was significantly
reduced in beet (by 55%) and oilseed rape (by 12%), but not in maize6. The
number and quantity of active ingredients were substantially reduced in
beet and maize, but not in spring rape. The cost of the herbicides applied
to the GMHT crops, especially beet, is likely to be considerably less than
the current cost of conventional herbicides. Other studies7 have shown a
potential benefit of ú150/ha (approx. USD$110/acre) to be gained from
growing GMHT sugar beet compared to conventional crops. These are
important considerations for farmers and would contribute to the
decision-making process if the crops were to become available.

Mitigation of Adverse Environmental Effects

Are the FSE results bad enough to persuade the government to ban GMHT
crops for general release? More than anything else, what these studies
have revealed for the first time on a large scale is that intensive
agriculture is having a gradual, but nevertheless inexorable, effect on
the diversity of life within the UK farmed landscape. These studies showed
that there were greater differences between crops than between the
herbicide treatments within any individual crop. Conventional maize for
example was the least diverse crop, but both conventional and GMHT oilseed
rape were more diverse than the others8. The declines in seedbanks that
have been highlighted will continue whether or not GM crops are
introduced, although there is evidence that the rate of decline of seeds
in the seed bank would be significantly enhanced by the technology1.
However, it is not the introduction of GMHT crops that needs to be
addressed, but the way in which society wants food to be produced in the
future.

There are two approaches to this:

1) A return to low intensity farming¸this would require more land to be
brought into production to compensate for the reduced yields that would
inevitably ensue; or

2) Further intensification on the most productive areas of land¸this would
allow less productive areas to be returned to wildlife.

Both approaches would require some financial encouragement, and indeed
both approaches could be used in tandem. However, some scenarios could be
achieved only with GM technology. For example, taking a relatively
low-intensity approach, we have devised a method within GMHT sugar beet
that allows weeds to survive longer between the rows early in the season
to the benefit of some wildlife. Glyphosate is applied as a band spray at
first application (by using a cheap modification of the nozzles on an
existing spray boom) at the 2÷4 leaf stage of beet plants, followed by a
later overall application that removes weeds when they become competitive.
The optimum timing of the latter spray depends on the density and species
composition of weeds in the field. None of the conventional herbicides
used in sugar beet would be able to achieve this effect, as they give poor
control of weeds with more than 2÷4 leaves. This approach encourages
insects and other invertebrates to remain in the crop for longer9, reduces
the number of pests by camouflaging the beet plants and encouraging
predators10, and can offer greater food resources and habitat for
ground-nesting birds at a time of year when such resources are scarce in
the arable environment. Yields from band-sprayed plots were as good as
those from plots receiving conventional herbicides, and the cost of the
herbicides was much cheaper, so there is a great financial incentive to
growers to pursue this strategy.

Another alternative to increase the number of seeds available for
granivorous birds later in the season has been to apply glyphosate once
overall early in the season. This allows later emerging, but
non-competitive weeds to mature and produce seeds. Of course both methods
produce crops that look untidy, at least for part of the season, and this
will require growers to re-think their approach to crop production¸a
pristine crop is not necessarily an environmentally-friendly one. However,
the power of GMHT technology allows growers to have confidence that yields
will not be adversely affected even if some weeds remain in the crops, and
that would make it easier to persuade them to adopt these low intensity
approaches.

The second approach, to increase the intensity of cropping, is likely to
be more acceptable to growers, but probably not environmentalists. Given
that crops do need to be grown to produce food, some compromise is
necessary. Is it better to provide a larger area of poor diversity or many
small areas of rich diversity? This question needs to be tested on a
landscape scale.

The high intensity philosophy is to increase production in the most
fertile parts of the fields, namely the field centres. Headlands would not
be cropped, but would instead be made into set-aside areas with either
natural regeneration, or, if necessary, sown with mixtures of wild flower
seeds or species to encourage wildlife. Strips of untreated areas would
also be left through the fields themselves to mitigate the losses of seeds
caused by either conventional or GMHT cropping. However, the influences of
this latter approach on populations of farmland birds cannot be examined
until large scale ecological studies are set up.

Conclusion

The adverse effects reported to be due to GMHT beet and oilseed rape crops
were due to the more efficient control of weeds by the respective
broad-spectrum herbicides applied to those crops. In the same way, the
better control of weeds by use of the broad-spectrum residual herbicide
atrazine caused the same effects in conventional maize crops. More
creative use of herbicides such as glyphosate and glufosinate-ammonium
could reverse these effects within crops, but more intensive agricultural
production of the most fertile land could allow less productive land to be
used for the benefit of wildlife.

References

1. Heard MS et al. (2003a) Weeds in fields with contrasting conventional
and genetically modified herbicide-tolerant crops. 1. Effects on abundance
and diversity. Phil. Trans. R. Soc. Lond. B. 358: 1819-1832.

2. Heard MS et al. (2003b) Weeds in fields with contrasting conventional
and genetically modified herbicide-tolerant crops. 2. The effects on
individual species. Phil. Trans. R. Soc. Lond. B. 358: 1833-1846.

3. Brooks DR et al. (2003) Invertebrate responses to the management of
genetically modified herbicide-tolerant and conventional spring crops. 1.
Soil surface active invertebrates. Phil. Trans. R. Soc. Lond. B. 358:
1847-1862.

4. Haughton AJ et al. (2003) Invertebrate responses to the management of
genetically modified herbicide-tolerant and conventional spring crops. 2.
Within-field plant epigeal and aerial arthropods. Phil. Trans. R. Soc.
Lond. B. 358: 1863-1878.

5. Roy DB et al. (2003) Invertebrates and vegetation of field margins
adjacent to crops subject to contrasting herbicide regimes in the Farm
Scale Evaluations of genetically modified herbicide-tolerant crops. Phil.
Trans. R. Soc. Lond. B. 358: 1879-1898.

6. Champion GT et al. (2003) Crop management and agronomic context of the
Farm Scale Evaluations of genetically modified herbicide-tolerant crops.
Phil. Trans. R. Soc. Lond. B. 358: 1801-1818.

7. May M. (2003) Economic consequences for UK farmers of growing GM
herbicide tolerant sugar beet. Ann. Appl. Biol 142: 41-48.

8. Hawes C et al. (2003) Responses of plants and invertebrate trophic
groups to contrasting herbicide regimes in the Farm Scale Evaluations of
genetically modified herbicide-tolerant crops. Phil. Trans. R. Soc. Lond.
B. 358: 1899-1915.

9. Dewar AM et al. (2003) A novel approach to the use of genetically
modified herbicide-tolerant crops for environmental benefit. Proceedings
of the Royal Society: Biological Sciences 270 (1513): 335-340.

10. Dewar AM et al. (2000) Delayed control of weeds in glyphosate-tolerant
sugar beet and the consequences on aphid infestation and yield. Pest
Management Science 56(4): 345-350.

Alan M. Dewar, Mike J. May and John D. Pidgeon
Broom's Barn Research Station, Higham,
Bury St. Edmunds, Suffolk, IP28 56NP, UK
Alan.dewar@bbsrc.ac.uk
************************************

http://timesofindia.indiatimes.com/articleshow/484050.cms

Apex panel on GMOs getting its act together

- Times of India, Feb 8, 2004

NEW DELHI : The Union government's apex regulatory body on
genetically-modified organisms knows it needs a makeover if it wants to
blunt criticism and stay where it is in the environment ministry. So, when
it met after a two-month gap last week, it decided to begin the revamp
with one small step: Fixing a day every month for meetings.

This has been a long-standing complaint, the argument being that
environment ministry mandarins know nothing about the urgency of crop
seasons, pharma concerns and bureaucrats have no business heading a
committee with representatives from different ministries and departments.

That criticism will be muted by this. In fact, the Genetic Engineering
Approval Committee, with a new chairperson leading it, discussed the
source of one possible attack: An agriculture ministry task force chaired
by father of Green Revolution in India scientist M S Swaminathan, in the
process of finalising its report. The message: We're trying to rationalise
policy and streamline the regulatory process.

GEAC, we are now told, has the "highly sensitive and delicate
responsibility" of harmonising between the demands for scientific and
technological progress in the fields of agriculture and pharmaceuticals
and the environmental concerns associated with these processes in what is
still an evolving field.
****************************************

How Much Should We Worry about Biotech?

- Tony Gilland vs. Carol Foreman, The American Enterprise (Special Issue
on 'Biotech Bounty'), March 2004 http://www.taemag.com

---------------------------------------

POINT: The Culture War Behind the Biotech Battle: How Irrational Fear
Could Really Give Us Something to Worry About

By Tony Gilland

When U.S. Agriculture Secretary Ann Veneman and U.S. Special Trade
Representative Robert Zoellick announced in May 2003 that the U.S. would
file a case at the World Trade Organization against the European Union's
moratorium on the approval of new genetically modified (G.M.) food
products, the U.S. agriculture industry no doubt found itself asking,
"What took you so long?" After all, the E.U.'s approach to the assessment
of the health and environmental impact of G.M. foods has been based on
shaky scientific foundations from the start.

Newspapers on both sides of the Atlantic cast the U.S. challenge in terms
of a brewing trade war. Commentators noted that the Europeans are trying
to protect their over-subsidized farmers from the pressures of
international competition, and that opposition to G.M. foods is part of
this anti-free-trade strategy. While there may be important trade aspects
to the rift between Europe and the U.S. over genetically modified foods,
the issues at stake in this debate are more profound and complex. We
appear to be witnessing not just a trade war, but a culture war.

On issues of science and technology these days, Europe is often guided by
the idea that innovation should only proceed when there is a guarantee
that the outcome will not be harmful. Europe isn't alone in this regard;
heightened preoccupation with risk has become a global phenomenon, and is
by no means confined to issues such as genetically modified organisms.
Alongside every debate over global warming, biodiversity, waste disposal,
nuclear power, sustainable development, electromagnetic fields, human
genetics, and, more recently, nanotechnology, lie fundamental questions
about the dynamism of science and technology, man's relationship with
nature, and the role of corporations.

We should view the issue of G.M. crops and food in this context. Operating
within a "precautionary principle" that demands proof that life will
improve before changes are allowed in the status quo, scientists,
politicians, and industrialists favorable to genetic engineering have
found themselves poorly equipped to make a positive case for its
implementation. Hypothetical worstcase scenarios, often with little
theoretical plausibility, are combined with claims of minimal benefits for
consumers. Why should we accept even the most minimal of risks? Too often,
the response of authority figures to these challenges has been to
implement increasingly restrictive regulatory controls, and to commission
yet more research in a vain attempt to assuage the unassuageable demand
that there be no unforeseen adverse consequences from new technologies.

The bumbling way in which policy makers have handled the issue of G.M.
foods, particularly within Europe, has established worrying precedents for
the way that modern societies relate to science, technology, and
innovation generally. Technical and regulatory responses to public
concerns about health and environmental issues have not worked in Europe;
emotional and psychological appeals have often carried the day.

Of course sensible regulations should be employed when genuine issues of
safety or adverse consequences are at stake. But this is not what the
E.U.'s regulatory approach to G.M. foods has been about. Working first of
all in anticipation of potential negative public reactions to
biotechnology, then in response to pressure from interest groups and media
campaigns, and eventually in concert with food retailing interests, the
E.U. has introduced tighter and tighter regulations against G.M.
technology.

The clear aim of these controls has been to cater to public perceptions,
rather than scientific questions of health or environmental safety.
Consequently, the regulations inevitably end up embodying exaggerated, if
not spurious, concerns in an attempt to reassure the public that
everything is being done to protect them. Public worries, rather than
being properly addressed, challenged, and put into perspective, are thus
validated and institutionalized. Once governments and regulatory bodies
have demonstrated their willingness to regulate the hypothetical in this
way, the door is opened to further demands for controls based on other
equally emotional or hypothetical concerns.

In May 2003, on the same day that the U.S. filed its case against Europe's
moratorium on imports of genetically modified food, E.U. Commissioner for
the Environment Margot Wallstrom proclaimed, "We should not be deflected
or distracted from pursuing the right policy for the E.U." The key phrase
here is "the right policy for the E.U. "Wallstrom is arguing that a
scientific assessment of the health and environmental impact of G.M. crops
and food is not a universal reality, but something specific to the culture
of E.U. member states. She asserts that bowing to these cultural winds is
the responsible approach.

The E.U. suggests that its proposed complex system requiring labeling of
any food produced from a G.M. organism, regardless of the presence or
absence of novel genetic material, combined with stringent and voluminous
"traceability" requirements throughout the food system, will allow the
moratorium on all gene engineering to be lifted without a politically
frightening public outcry. Wallstrom criticized the timing of the U.S.
filing of its WTO case for threatening the efforts of the E.U. to get this
far.

Yet the outcome of the E.U.'s approach will only be to exacerbate
unfounded fears. The whole character of these regulations is informed by
the unwillingness of those in authority to challenge the risk-averse mood
of our times. Instead, a system of regulation is being established that
(1) reinforces the idea that something might go wrong and cause us to be
poisoned; and (2) tells the consumer that the decision over the safety of
the food he purchases is his responsibility, not something for scientists
and experts to judge.

Emblazoning markers on G.M. foods constitutes a huge abdication of
responsibility on the part of the E.U. and member state governments. What
is the point of having an army of scientific experts across Europe
investigating every aspect of this technology if they are not allowed to
give us the benefit of their expertise? (As it happens, scientists are not
alarmed by G.M. technology.) Rather than tell us what it really thinks,
and therefore take responsibility for a decision, the E.U. would rather
cover its back and demand that consumers, who in all honesty cannot be
expected to be well informed on all safety aspects of G.M. food, take
responsibility for making the decision.

The E.U. may well eventually approve new biotech products and commercial
uses of G.M. crops within Europe--simply because it is difficult to hold
out against the use of technology on irrational grounds indefinitely. But
this will not be thanks to the continent's regulators. And given the
experience to date in my homeland of Britain, the possibility cannot be
entirely ruled out that Europeans will just let the biotechnology train
pass them by. Indeed, the more Europe moves down the route of defining its
own "culturally acceptable" approach to dealing with scientific
risk--rather than confronting the climate of fear--the more that this is
likely to be the case.

There are numerous potential candidates to blame for the G.M. debacle in
Europe. National governments have vacillated; the media have scaremongered
against the technology; activist groups often exaggerate even the
slightest concerns; and retailers deserve some of the blame for the speed
with which they have dumped G.M. products when they caught a whiff of
controversy. To apportion blame in this way, however, would be to gloss
over the more profound social processes that shaped the G.M.
debate--processes that may also endanger many other technologies.

The way the G.M. issue has been handled in Europe indicates just how
quailingly risk-averse many modern people have become. At every stage, the
scientific issue of the risks and benefits of G.M. crops was subsumed
beneath an overreaching psycho-political insistence on holding back, lest
something-- anything!--should go wrong. That an important and potentially
beneficial technology such as this could be retarded "just in case"
indicates a fundamental value shift within contemporary society.

This has practical consequences for how science and technology will unfold
in the future. We are shifting from the belief that progress is a social
good, and that science and technology should be developed for the benefit
of humanity, toward a new distrust of the consequences of progress. That
could result in a severe overreaction, restricting science and technology
even when the potential rewards greatly eclipse the potential risks.

Why has this shift in values and priorities taken place? Not because life
has become more dangerous. We live healthier, wealthier, and safer lives
than at any time in history.

It is also clear that reactions against certain new technologies have very
little to do with the technologies themselves. Despite the fearful focus
on G.M. crops and food in the U.K. and Europe, and the never-ending
process of testing and monitoring this technology, there remains no
scientific evidence that G.M. crops will acutely harm humanity or the
environment.

Rather, the resistance to agricultural biotechnology reflects a growing
distrust of political authority and scientific expertise. Combined with an
increasingly individualized and consumerist society, this has led to a
situation in which unfounded fears can take hold very rapidly, spread by
unofficial sources such as the media, campaign groups, and maverick
scientists. Rather than attempting to counter these scares directly, the
official approach has been to bend over backwards to take such fears, no
matter how exaggerated, into account--thereby implicitly endorsing them.

In this way, unfounded fears give rise to unfounded bans and controls.
Which, in turn, create the basis for yet more fear. And thus encourage
even more stifling regulation of the human impulse to explore, discover,
and improve the world around us.

--- Tony Gilland is science and society director at the Institute of Ideas
in London.

***********

COUNTERPOINT: Killing the "Frankenfood" Monster: How People Can Love, Not
Fear, Biotech Food

- By Carol Foreman

Unlike Europeans, most Americans are not strongly opposed to agricultural
biotechnology. But that doesn't mean they are enchanted by it. Polls show
that Americans have never been enthusiastic about gene-altered foods, and
their willingness to purchase genetically altered foods appears to be
waning. While American consumers have been eating genetically modified
foods for a decade now, farmers, the biotechnology industry, food
processors, and government regulators ignore possible future consumer
discomfort their own peril. The next generation of genetically modified
products will be much more visible to consumers, spurring active
opposition. The question is whether industry and government will act to
make sure concern doesn't turn to outright rejection.

The agricultural biotechnology industry and some government regulators
argue that we should stop worrying and learn to love genetically modified
food because the current products are based on "sound" science, are good
for farmers, safe for consumers, and often beneficial for the environment.
But this ignores the powerful cultural and personal attachments that most
of us have to our food. From the apple in the Garden of Eden to the Golden
Arches, food--what, how, and in what quantity we eat-- has played a
central role in our lives. We eat to live but we also live to eat. Food is
more than fuel for the body. Since what we eat literally becomes part of
our bodies, food is the source of some of our greatest pleasures and, not
surprisingly, greatest fears.

Throughout history, people and cultures have been distinguished by what
they are obligated or forbidden to eat. Jewish and Muslim dietary laws
prohibit eating pork. Hindus abstain from beef. Christians may forego
certain foods during Lent. Beans were a forbidden food in the ancient
Pythagorean cult to which Plato belonged. Many believers would go hungry
before violating these proscriptions.

Historically, people connected "purity" with "safety," and these notions
were factored into early food safety requirements. Today, modern science
defines safety solely in terms of toxicology, microbiology, and nutrition,
but people have not relinquished their quest for purity and wholesomeness.
"Organic" and "free range" foods are attractive to consumers precisely
because they respond to that yearning.

Psychologists who specialize in risk perception tell us that people fear
most those risks they perceive as unknown, uncontrollable, and potentially
catastrophic. It should not be surprising that many consumers are uneasy
about genetically modified food. Even though there is no evidence anyone
has gotten sick from eating G.M. foods, survey data show acceptance of
G.M. foods has declined over the past several years. There were somewhat
fewer Americans willing to purchase genetically modified food in 2003 than
there were in 1999. The number of respondents who found it unacceptable to
use biotechnology to protect crops from insects rose from 18 percent in
1992 to 27 percent in 2000. A recent study by the U.S. Department of
Agriculture found that consumers were willing to pay an average of 14
percent more for food that appeared to be free of genetically modified
ingredients. "Consumers' willingness to pay for food products decreases
when the food label indicates that a food product is produced with the aid
of modern biotechnology," the USDA reported. Events such as the "Starlink"
contamination, in which corn that had been approved only for animal feed
got into breakfast cereal and chips, result in less support for biotech
food.

There are a number of possible explanations for the existence of public
skepticism about food biotechnology:

Our current biotech products were developed for growers, not eaters. So
far, biotech companies have focused on seeds and crops, not foods. When
they think of customers, they see farmers, not supermarket shoppers. When
they imagine benefits, they see lowered input costs, not lower retail
prices. Reducing the price of producing corn is good for farmers, but does
not necessarily translate to lower prices at the store. Moreover, the
current biotech crops have not resulted in food that is more nutritious or
better tasting. The food industry and the U.S. government have urged
people to accept G.M. foods now because someday there will be new products
that have direct consumer benefits. But this lacks immediate appeal. One
argument for G.M. products that is likely to appeal to consumers is the
fact that the technology has reduced reliance on the most toxic
pesticides. Given public concern about pesticide residues, it is
surprising that supporters haven't emphasized this benefit more.

The food biotechnology industry suffers from self-inflicted wounds. The
refusal to label genetically modified food products almost surely
contributes to public suspicion that there is something wrong with these
products. It is human nature to suspect that, if you act covertly, you
must have something to hide. The opposition to mandatory labeling, despite
a plethora of polls showing consumers overwhelmingly want this
information, impairs the credibility not just of biotech producers, but of
food processors and government regulators as well.

Whether genetically modified animals become part of our food supply raises
moral, ethical, and cultural questions which industry and government
cannot ignore. People relate differently to animals than to plants. When
the first biotech corn hit the market, no one thought to name it Bt Betty
and flash photos on television, but the birth of Dolly, the first cloned
sheep, touched off media frenzy. Her placid face stared out from
newspapers and television sets around the world. Polls show greater
reservations about transgenic and cloned animals than about crop
biotechnology.

The current regulatory system is convoluted and illogical. Most of the
laws were written before food biotechnology was developed or even dreamed
of. Three agencies and ten statutes overlap. The FDA, the nation's primary
food safety agency, does not examine and declare plant products safe for
human consumption before they are allowed on the market. It is illegal to
market a genetically modified plant without USDA approval that the plant
will not harm other plants, or to market a genetically modified
pest-protected plant without EPA approval that the plant will not harm the
environment. Only the process for determining human safety is voluntary.
The FDA regulates animals rigorously.

The FDA must find that the product is both safe and effective before it is
sold. But the entire proce