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July 28, 2004
GENETIC MODIFICATION
AND FOOD
The
Institute of Food Science & Technology, through its Public
Affairs and Technical & Legislative Committees, has authorised
the following Information Statement, dated 27 July 2004,
replacing the Statement of September 1999 and any previous
version.
SUMMARY
Genetic modification (GM) has the
potential to offer very significant improvements in the
quantity, quality and acceptability of the world's food supply.
Food scientists and technologists
can support the responsible introduction of GM techniques
provided that issues of product safety, environmental concerns,
information and ethics are satisfactorily addressed. IFST
considers that they are being addressed, and need even more
intensively to continue to be so addressed. Only in this way may
the benefits that this technology can confer become available,
not least to help feed the world's escalating population in the
coming decades.
Introduction and definitions
Food
biotechnology is the application of biological techniques to
food crops, animals and micro-organisms to improve the quality,
quantity, safety, ease of processing and production economics of
food. It thus includes the traditional food manufacturing
processes used for bread, beer, cheese and various fermented
milk products.
A
relatively more recent (i.e. starting about 25 years ago)
application of biotechnology to food is genetic modification
(GM), also known as genetic engineering, genetic manipulation,
gene technology and/or recombinant DNA technology. The
collective term "Genetically Modified Organisms" or GMOs is used
frequently in regulatory documents and in the scientific
literature to describe plants, animals and micro-organisms which
have had DNA introduced into them by means other than by
combination of an egg and a sperm or by natural bacterial
conjugation.
Random
genetic variation occurs naturally in all living things and is
the basis of evolution of new species through natural selection.
Even before its scientific basis was understood, mankind took
advantage of this natural variation by selectively breeding wild
plants and animals and even micro-organisms such as yogurt
cultures and yeasts, to produce domesticated variants better
suited to the needs of humans. Such selective breeding involves
the transfer of unknown numbers and kinds of genes between
individuals of the same species. Before the advent of GM
technology, however, so-called "traditional" or "conventional"
breeding technology involved far more than the foregoing. Over
the past half-century it also included techniques involving
polyploidisation and mutagenesis via x-rays, which are far more
disruptive of the original plant genes than any GM modification.
For example barley seeds (Golden Promise) were treated with
x-rays in the Winfrith reactor in 1956 to yield the
UK's
favourite variety for brewing -- and this variety is also used
in the production of organic beer.
Many
changes to food materials brought about by gene technology are
no different in essence from those which can take place in
nature or by selective breeding, except that the gene
technologist transfers a carefully targeted selected few
specific genes, thus drastically reducing both their random
nature and the time taken to produce an improvement.
Thus,
within-species GM involves few fundamentally new issues.
However, gene technology also makes it possible to move genes
between different species. This property makes the technique
revolutionary in terms of the potential benefits that it may
bring but it has also caused concern regarding issues of safety,
ethics, environmental impact and consumer choice.
Techniques of genetic modification
How is GM
technology carried out? In simple terms, the gene technologist
uses a "cutting-copying-pasting" approach to transfer genes from
one organism to another. For this, bacterial enzymes are used
that recognise, cut and join DNA at specific locations acting as
molecular "scissors-and-tape". However, the selected gene is
copied billions-fold, with the result that the amount of
original genetic material in the modified organism is
immeasurably small. Since DNA does not always readily move from
one organism to another, "vehicles" such as plasmids (small
rings of bacterial
DNA) may be used; alternatively, some plant cells may be transformed by
"shooting" small particles coated with the new
DNA into the
target cell using a special type of gun, the "Gene Gun". The
modified cell can then be used to regenerate a new organism.
However,
by currently available methods only small numbers of cells
subjected to a genetic modification procedure are successfully
modified. Furthermore, the regeneration of whole plants or
animals from culture cells may take months or years.
Consequently, it is necessary to identify the modified cells in
a culture mix using "marker genes" closely linked to the genetic
material to be transferred. Antibiotic resistance has often been
used to "tag" genes so that they can be detected easily and
rapidly at the cellular level in the laboratory, providing a
basis for selection. The use of antibiotic resistance marker
genes (ARMG) has, however, been a source of concern.
Although
the transfer of antibiotic resistance from a marker gene
contained in a GM plant to a microorganism normally present in
the human gut has not been demonstrated experimentally, it has
been suggested that the potential risk, however small, of
spreading resistance to therapeutic antibiotics could have
serious health consequences and therefore should be avoided. In
the absence of reliable data, the UK Advisory Committee on Novel
Foods and Processes (ACNFP) erred on the side of caution and
recommended some years ago against the use of antibiotic
resistance marker genes.
However, on
4 February 2004 a Working Party of the British Society for
Antimicrobial Chemotherapy
http://www.bsac.org.uk/ stated
"There are
no objective scientific grounds to believe that bacterial
antibiotic resistance genes will migrate to bacteria to create
new clinical problems."
They
looked at various routes "but are unable to identify a credible
scenario whereby new drug-resistant bacteria would be created".
However they point out that the theoretical possibility of
transfer by novel mechanisms cannot be entirely ruled out, and
so consider whether transfer of the three drug resistance genes
that have been used would pose a threat to antibiotic use in
medical treatment. These 3 genes are common in bacteria, and
found on mobile elements that move between DNA molecules and
bacterial cells, and this gene mobility has already compromised
clinical use of the antibiotics.
"The
argument that occasional transfer of these particular resistance
genes from GM plants to bacteria would pose an unacceptable risk
to human or animal health has little substance. We conclude that
the risk of transfer of AR genes from GM plants to bacteria is
remote, and that the hazard arising from any such gene transfer
is, at worst, slight."
The
Working Party goes on to ask "Can a blanket ban on cultivation
of GM plants carrying bacterial drug resistance genes be
justified, even in part, because of extremely improbable,
unquantifiable concerns?". They argue that a precautionary
principle approach that argued that such a negligible risk must
prevent the use of plants containing such genes, must be set
against a pragmatic approach that takes account of the size of
the risk and hazard and also the potential benefits of GM
plants, such as reduced pesticide use. While the Working Party
believes that the evidence means that most bacterial AR genes
would be safe, they "consider it extremely undesirable and
unnecessary to extend the list of AR genes approved for GM plant
development. In particular, the use of any AR gene that if
disseminated widely among bacteria would be likely to compromise
use of a front-line or currently widely used antibiotic should
be strongly discouraged, if not banned." They note that plant
biotechnologists chose not to uses AR genes in this category.
And conclude "The moratorium should continue, particularly as
alternatives to AR genes are being developed".
On 16 April
2004 the European Food Safety Authority (EFSA) issued a
scientific opinion
http://www.efsa.eu.int/press_room/press_release/386_en.html
on the subject, classifying those evaluated into 3 groups based
on their biological distribution and taking into account the
current importance of the antibiotics concerned to human and
veterinary medicine ... The EFSA GMO Panel has proposed the
following classification for ARMGs:
· Group
1 ARMGs contains antibiotic resistance genes which (a) are
widely distributed among soil and enteric bacteria and (b)
confer resistance to antibiotics which have no or only minor
therapeutic relevance in human medicine and have only restricted
use in defined areas of veterinary medicine. This refers to the
antibiotic resistance genes nptII conferring resistance to the
antibiotics kanamycin and neomycin with a 13-year history of
safe use in food crops and the hph gene which encodes for a
protein that inactivates hygromycin, an antibiotic that is not
utilised in human clinical medicine. No restrictions are
required with this class of marker genes either for field
experimentation or for placing on the market ...
· Group
2 ARMGs contains antibiotic resistance genes which (a) are
widely distributed in micro-organisms in the environment and (b)
confer resistance to antibiotics which are used for therapy in
defined areas of human and veterinary medicine. This group
includes genes which confer resistance to chloramphenicol (CmR
gene), ampicillin (ampr gene) and streptomycin and spectinomycyn
(aadA gene). The use of these genes should be restricted to
field trial purposes and not be present in GM plants placed on
the market ...
· Group
3 ARMGs contains antibiotic resistance genes which confer
resistance to antibiotics highly relevant for human therapy like
the nptIII gene conferring resistance to amikacin and the tetA
gene conferring resistance to tetracyclines. Irrespective of
considerations about the realistic importance of the health
threat, these genes should be avoided in the genome of
transgenic plants to ensure the highest standard of preventive
health care. Therefore these ARMGs should not be present in GM
plants placed on the market or in plants used for experimental
field trials.
However,
other methods are becoming available. In a development, reported
in Science in May 1999, researchers at
University of
Hawaii
demonstrated the use of sperm to transport "foreign"
DNA into an egg. It has a relatively high rate of
success, is technically simple to carry out, has potential for
transferring larger pieces of
DNA and is applicable to animals.
Advantages and potential benefits of genetic modification
For the
development of improved food materials, GM has the following
advantages over traditional selective breeding:
- Allows a
much wider selection of traits for improvement: e.g. not only
pest, disease and herbicide resistance (as achieved to date in
plants) but also potentially drought resistance, improved
nutritional content and improved sensory properties
- It is
faster and lower in cost
- Desired
change can be achieved in very few generations
- Allows
greater precision in selecting characteristics
- Reduces
risk of random occurrence of undesirable traits.
These
advantages could, in turn, lead to a number of potential
benefits, especially in the longer-term, for the consumer,
industry, agriculture and the environment:
- Improved
agricultural performance (yields) with less labour input and
less cost input
- Benefits
to the soil of “no-till” farming practice
- Reduced
usage of pesticides and herbicides
- Ability
to grow crops in previously inhospitable environments (e.g.
via increased ability of plants to grow in conditions of
drought, soil salinity, extremes of temperature, consequences
of global warming, etc.) leading to improved ability to feed
an increasing world population at a reduced environmental cost
- Improved
sensory attributes of food (e.g. flavour, texture, etc.)
- Removal of
allergens or toxic components, such as the research in USA to
produce a non-allergenic GM peanut (University of
Arkansas) and a
non-allergenic GM prawn (Tulane
University) ; and in Japan,
to produce a GM non-allergenic rice.
- Improved
nutritional attributes such as:
- Ingo
Potrykus's EU research project jointly funded by the
Rockefeller Foundation, resulting in increased Vitamin A
content in rice, which will help to prevent blindness among
children in Southeast Asia;
- the
announcement in September 2003 by Edgar Cahoon and his team
at the Donald
Danforth Plant
Science Center in Missouri
that by inserting a gene extracted from barley into a common
type of field corn, they have created a strain that grows
with six times the usual amount of vitamin E, a powerful
antioxidant.
- Improved
processing characteristics leading to reduced waste and lower
food costs to the consumer.
-
Prevention of loss of species to endemic disease (e.g. the
Cavendish dessert banana which is subject to two fungal
diseases that have struck Africa, South America and Asia, but
could be reprieved by GM development of a disease-resistant
version).
GM has
huge potential for mankind in medicine, agriculture and food. In
food, the real benefits are not the early instances that have
been appearing so far, but its longer-term benefit to the world
- and especially the developing countries - its potential for
developing crops of improved nutritional quality, and crops that
will grow under previously inhospitable conditions (see above),
thereby contributing to alleviating hunger and malnutrition,
while helping to prevent the otherwise inevitable future
pressure to encroach on natural resources. Even today, there are
840 million people. 800 million of them in the developing
countries and 200 million of them children, who regularly do not
receive enough food to alleviate hunger, still less provide
adequate nutrition. 24,000 people die of malnutrition-related
causes daily. That situation will be greatly worsened as a
result of the world's escalating population over the coming
decades.
There
are those who allege that “scientists claim that GM will solve
the problem of world hunger”. This is a familiar "straw man". It
is frequently argued by some that there is more than enough food
to feed the world and all that is needed is "fairer
distribution" (which so far mankind has signally failed to
achieve) – or a variant of that, "the real problem is not
shortage of food, it is poverty". Whatever may be done by way of
improved yields through conventional methods, attempted
population control and more effective distribution would,
however, be inadequate for the future. There are probably enough
cereals to feed the present world population (if only they could
be distributed to the right places at the right times and could
be afforded). But there will be substantial shortfalls in
cereals in the next two decades. Moreover, "world hunger" is a
complex not only of inadequate quantity where it is needed but
of inadequate quality i.e. for vast numbers of people the lack
of foods with the necessary micronutrients and of clean water,
for reasonable nutrition and health.
However, In decades to come, with
the expected substantial increase in the world population,
mostly in the poorest, least developed countries, the demand for
increased agricultural land and for water will greatly increase.
The important point is not only how to feed the world now but
addressing and trying to solve the problem of "How shall mankind
feed the world in a few decades from now?". Of course the
problem that has huge political and economic dimensions will not
be solved by GM alone, or even by science alone -- but will
certainly not be solved without the contribution of science,
including GM.
Food
scientists and technologists can support the responsible
introduction of GM techniques provided that issues of product
safety, environmental concerns, ethics and information are
satisfactorily addressed. so that the benefits that this
technology can confer become available both to improve the
quality of the food supply and to help feed the world's
escalating population in the coming decades.
Current
GM foods and food ingredients
The
"first generation" of GM food materials were those that were
relatively easy to do, chosen for their likelihood of rapid
commercial success by providing traits that would commend
themselves to farmers. Consequently, most of the 80+ crops that
have been modified and the 25,000+ field trials that have taken
place world-wide to date have involved crops engineered for
agronomic traits. The first food plants to be grown on a
commercial scale and put on the market were the GM maize
resistant to the European corn-borer, a serious agricultural
pest, and the soyabean genetically-modified to be tolerant of
the herbicide glyphosate. The latter involves one or two
applications of a less toxic, more rapidly broken down herbicide
than the spraying regime that it replaces, that of several
applications of different herbicides.
However,
these GM products did not offer consumers a readily perceivable
benefit “at the point of purchase”; and with intensified
campaigns and media amplification in the early part of 1999 and
thereafter highlighting problems and uncertainties (some real,
some pure speculation, some spin-doctored and some urban myths),
the UK public became turned against GM. Reacting to their
customers' views, major retailers and manufacturers decided to
exclude GM foods and ingredients.
An
incidental victim was the canned tomato puree, prominently
labelled "Produced from genetically modified tomatoes", on sale
in stores of two major supermarket groups in competition with
non-GM tomato puree. The GM tomato puree was of better flavour
and consistency, cheaper, and consistently outsold the non-GM
puree. It is now no longer available
Chymosin,
produced by GM micro-organisms, was developed to replace rennet,
the milk-clotting enzyme used extensively in cheese-making, due
to the severe shortage of the traditional source of the enzyme
(i.e. calf stomachs). The GM enzyme, defined as a processing aid
rather than a food additive in regulatory terms, has been in use
since the late 1980s in the USA and in some European countries,
including the
UK.
It is not clear whether it will survive in the current climate.
What are
the concerns about GM?
Increasingly at the heart of the "concerns" debate about GM, is
the fundamental matter of the role of science and society in
relation to "new" science-based developments such as GM.
There
are two ways of dealing with new developments with associated
problems and uncertainties. One is to reject or ban the
developments. The other is to address and solve the problems,
and to accept that there are no certainties in any aspect of
life. Fortunately in the long run mankind has generally adopted
the second course, otherwise we would still be living in the
Stone Age. Looking at more recent times, there would be no
electricity; the first passenger flight would not have taken
place, so there would be no air travel; the first surgical
operation would never have been carried out so there would be no
surgery; the first anaesthesia would never have been used, so
there would be no anaesthetics (it is worth recalling that the
medical profession of the day prevented Queen Victoria from
having anaesthesia with the difficult births of her first seven
children ("not natural, not proved safe, not sufficient testing,
what about the long term effects?") -- the list could be
endlessly extended.. Exactly the same arguments were used in the
early decades of the 20th century to try to prevent the
legalisation of milk pasteurisation. Fortunately it was
eventually legalised and over the last seven decades has saved
untold numbers of lives that would otherwise have continued to
be lost to milk-borne tuberculosis -- second only to clean water
as the most important public health measure ever adopted.
Science
depends on gaining knowledge, organising it into a coherent
structure, hence improving understanding, and applying it. It is
society's tool and method for doing so. However, we can never
know everything there is to know about a topic. The one certain
thing about life is that nothing in life is certain. Science
cannot prove that anything is "safe" (i.e. absence of
harm) because "absence of evidence" is not "evidence of
absence". So any policy purportedly based on requiring science
to prove safety is unrealistic.
In real
life, decision and action by society to meet its needs has to be
based, not on certainty but on using the best knowledge
available at the time, and on skilful selection of areas for
urgently needed research. In the absence of certainty it has to
involve the combination of risk analysis and the
precautionary principle, which are two inseparable sides of
the same coin. These lie at the very crux of any discussion on
the application of GM.
Risk analysis (RA) consists of
i. risk
assessment. a task for
scientists who are experts both in the topic and in the
methodology of risk assessment. Risk assessment should take
account of the likelihood of a risk occurring and its
seriousness if it does occur, and should be applied not only to
a potential course of action, but also to failure to take that
action and to alternative courses of action;
ii. risk
communication, a
multi-directional interchange of information between
legislators, the scientific community and the rest of society,
which should be an ongoing process; and
iii. risk
management, for
legislators to carry out on behalf of society in the light of i
and ii.
The
relationship involving these three activities in not a linear
one but one of dynamic and ongoing interplay.
The
precautionary principle (PP)
is a concept familiar to, and used by, food scientists and
technologists. It is at the heart of the Hazard Analysis
Critical Control Point (HACCP) preventive food safety system.
However,
various concepts and interpretations of PP abound, and a
widely quoted concept regards PP as a preferred
alternative to RA and its components. It is important to
understand that in real life PP and RA are
inextricably linked and need to be pursued hand-in-hand.
A
commonly expressed (but unrealistic) approach demands that PP
must be invoked
- where the
scientific evidence for safety is insufficient, inconclusive
or uncertain, or
- where
preliminary scientific evaluation suggests that effects on the
environment, health or safety may be unacceptable and/or
inconsistent with the chosen level of protection;
and PP may be applied
without waiting for the reality and seriousness of those risks
to become fully apparent.
This fails to recognise that
science can never produce conclusive results and cannot deal in
certainty, Moreover, experience teaches that the situation
envisaged is most likely to arise in areas (such as
biotechnology) where there are strong ideological agendas, in
pursuit of which some individuals, including, unfortunately,
some scientists, present unsubstantiated speculation,
assumptions and guesswork as though they were "preliminary
objective scientific evaluation". This sometimes takes the form
of published purported "research papers" which on scrutiny turn
out to be merely the authors' speculations and opinions,
complete with references to similar papers by like-minded
individuals.
If that
sort of presentation is considered enough to bring a development
to a halt, and, as we have seen, scientific evidence is always
insufficient and science cannot prove anything to be safe, it
can then be argued in perpetuity both by its ideological
opponents and by scientists who see further research as a
funding opportunity, that the development should not be resumed
"until we know more".
Purported "preliminary objective scientific evaluation" should,
therefore, always be very carefully scrutinised to ensure that
there is a broad scientific consensus that it is based on some
hard scientific evidence.
On 2
February 2000, the EU Commission issued a "Communication on the
Precautionary Principle" It is on-line at
http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf
It is an
oft-repeated environmental truism that we hold the world in
trust for future generations. It would be a betrayal of that
trust and an abdication of responsibility by the present
generation if science were to limit itself to collecting and
providing information about current biotechnology applications,
or if society were to limit itself to arriving at verdicts about
them. We (society and scientists as part of society) must not
behave as disinterested spectators standing on the sidelines and
observing problems that may stand in the way of providing future
generations with the potential benefits that GM can offer. We
have a duty to address and solve such problems. Science is
society’s tool for doing that.
"As
for the future, your task is not to foresee it, but to enable
it."
[Antoine de Saint-Exupery, The Wisdom of the Sands (1948)]
Thus,
the real questions to be answered are not "Is it safe? Is it
environmentally friendly?" but "What do we have to do to make it
safe? What do we have to do to make it environmentally friendly?
" Recognition of that is the touchstone of sincerity and
objectivity.
A joint
report on "Transgenic Plants and World Agriculture" was
published in July 2000 jointly by the
Brazilian
Academy
of Sciences, the Chinese Academy of Sciences, The Indian
National Science Academy, the
Mexican
Academy of Sciences, the National Academy of Sciences of the
USA, The Royal Society (UK) and the Third World Academy of
Sciences. It is available in printed form, published by The
Royal Society, and it may be accessed on-line as a pdf file at
http://www.royalsoc.ac.uk/policy/rep_fr.htm
The US
organization, the Center for Science in the Public Interest
(CSPI), which is no friend of corporations or of US regulatory
agencies, issued a report in November 2001, primarily from a US
perspective, entitled "Genetically Engineered Foods: Are They
Safe?" but which also included environmental considerations. It
mainly took the form of Questions and Answers by the
co-directors of the Biotechnology Project at
CSPI. The full text can be accessed on-line at
https://cspinet.safeserver.com/nah/11_01/index.html
However,
their "bottom line" conclusions were as follows:
1.
The genetically engineered foods
that are currently on the market are safe. By increasing yields
and reducing the use of pesticides, they benefit farmers and the
environment.
2.
To ensure that new genetically
engineered plants and animals are safe for humans and the
environment, Congress should institute a mandatory government
approval process that is open to public participation and
review.
3.
The Environmental Protection
Agency (EPA) should monitor the environmental impact of
genetically engineered crops. It should require more field
testing, enforce insect refuges for Bt crops, and adopt other
environmental safeguards.
4.
The U.S. government should fund
more research on genetic engineering, especially on fruits,
vegetables, and other crops that are not of great commercial
interest to the biotechnology companies.
5.
To enable developing nations to
benefit from biotechnology, the U.S. government should:
o
fund research and the training of
scientists,
o
help countries develop regulations
to ensure the safe use of genetic engineering to produce food,
and
o
press biotech companies to donate
technologies and allow free access to patents that are used to
produce genetically engineered seeds and animals.
On
21 February
2002, the US National Academy of Science (NAS) issued its report
Environmental Effects of Transgenic Plants. The report,
which was commissioned in January 2000 by USDA’s Animal and
Plant Health Inspection Service (APHIS), reviewed the scope and
adequacy of the APHIS component of the Federal regulatory
framework for biotechnology. As requested, the report evaluates
the evolution of APHIS’ regulatory program, assessed the
effectiveness of changes that APHIS had made to improve the
program over the years, and made recommendations for further
refinements, particularly involving three processes:
notification, permitting and petitioning for non-regulated
status. On 2 August 2002, USDA's Animal and Plant Health
Inspection Service (APHIS) announced the creation of the new
"Biotechnology Regulatory Services" (BRS) Unit within APHIS "to
focus on USDA's key role in regulating and facilitating
biotechnology".
The full news release is at
http://www.aphis.usda.gov/lpa/press/2002/08/bioreorg_brs.html
The World
Health Organization has issued
"20 Questions on Genetically Modified (GM) Foods". These
questions and answers have been prepared by WHO in response to
questions and concerns by a number of WHO Member State
Governments with regard to the nature and safety of genetically
modified food.
Safety
considerations
When
introducing any new technology, including gene technology, into
the food chain, there is a need to adopt appropriate safeguards
to protect human health. Most countries in the Western
hemisphere started developing regulatory controls well before
any GM foods reached the market. These controls were put in
place not because safety problems had been identified but
because of a lack of familiarity with GMOs. Although many of the
early concerns regarding the safety of GM foods have not
materialised, the precautionary approach has continued as it
remains important to ensure that no new hazards are created.
When
considering safety in relation to GM, generalisations cannot
validly be made. Instances have to be considered and studied in
a case-by-case approach, and each case should be assessed in
relation to the food involved, as ready for consumption, whether
by man or by animals.
Regulations in most countries, including the UK, include the
concept of substantial equivalence. This concept was developed
in the late 1980s by several national regulators and refined and
given international recognition by the Organisation for Economic
Co-operation and Development (OECD) in 1993 and further
developed by the FAO/WHO Consultation in 1996 with particular
reference to foods produced by modern biotechnology (fully
detailed on the Web sites of FAO and the UK Advisory Committee
on Novel Foods and Processes (ACNFP)). The concept is based on
the idea that existing organisms used as food or food sources
can serve as a basis for comparison when assessing the safety
for humans of modified foods or ingredients. If a new food or
component is considered to be substantially equivalent to an
existing food or component the theory is that it can be treated
in the same manner with respect to its safety and nutritional
assessments.
Acceptability or non-acceptability is established by determining
whether a novel food is substantially equivalent to an analogous
conventional food in terms of composition, nutritional
properties, toxin and allergen content, the amount consumed, the
type of processing (industrial or domestic) that the food might
undergo and consumption by vulnerable groups of people (e.g.
infants and the elderly). Foods are assigned to three
categories:
1.
Products that are shown to be
substantially equivalent to existing foods or food components
2.
Products that are substantially
equivalent to existing foods or food components except for
defined differences
3.
Products that are not
substantially equivalent to existing foods or food components
Where
differences are identified, extensive animal feeding and
toxicological trials are required. The establishment of
substantial equivalence is an analytical exercise which has to
be approached carefully. The comparison may be a simple task, or
very lengthy, depending upon the nature and experience with the
foods or components being compared. It must also contain a
dynamic element to take into account that the continuing
modification of a food will require that the most recent novel
food is compared with an appropriate former novel food and not
necessarily with the original and traditional counterpart.
An
understanding of substantial equivalence is key to understanding
the basis of GM regulatory controls. This brief outline may be
supplemented by studying the text of the Report of the Joint
FAO/WHO Consultation on Biotechnology and Food Safety
http://www.fao.org/es/ESN/food/pdf/biotechnology.pdf
The
question of antibiotic resistance marker genes (ARMGs)
has been addressed above.
There
are no inherent grounds for assuming that GM foods are more - or
less - allergenic than traditional foods. However, when
developing any novel foods, including GM foods, care must be
taken that allergenicity is not inadvertently introduced into
the diet. This requires assessment of the allergenicity of a new
protein by predictive methods, experimental testing and a
post-marketing surveillance based on traceability.
The
testing of GM products for suspected allergens can be done by an
IgE test with serum from sensitive individuals [e.g. Herian et
al (1990)]. However, there is also a need to test products where
genes have been inserted from sources not known to be
allergenic. Astwood et al (1996) have developed a method.
Stability of a protein or protein fragments to digestion in
simulated gastric fluid (SGF) may be used to assess the
potential allergenicity of a protein.
The British
Medical Association (BMA) in its earlier (1999) "interim
statement" on GM had been hostile to GM and called for an
open-ended moratorium on all commercial planting of GM crops
until more was known about their effects on human health. Indeed
that had been one of the factors influencing the visiting party
of Zambian scientists to return to Zambia with recommendations
against GM. "Doubts over the safety of genetically modified
foods voiced by the British Medical Association were the main
reason behind Zambia's decision to reject food aid in 2002, says
a Zambian scientist who visited Europe this week. Famine still
threatens 2.4 million people in Zambia today". New Scientist, 29
January 2003.
http://www.newscientist.com/news/news.jsp?id=ns99993317
However in
March 2004 the BMA issued a new statement
http://www.bma.org.uk/ap.nsf/Content/GMFoods/$file/GM.pdf
Announcing it they said
"The BMA
produced an interim report in 1999 on the health implications
of GM food crops. In accordance with our intention to keep the
public informed, we held a round table meeting of experts in
June 2003 and have recently reviewed the emerging evidence. In
producing an update of our 1999 report, the BMA seeks to support
balanced debate. As an organisation of doctors, we are not
experts in agricultural techniques and crop science, but we are
concerned with all issues of public health. The environment in
which we live, the air we breathe, the water we drink and the
food we eat, all have an impact on our health as individuals. It
is this context that the statement has been prepared. The BMA
shares the view of the Royal Society that that there is no
robust evidence to prove that GM foods are unsafe. However, we
endorse the call for further research and surveillance to
provide convincing evidence of safety and benefit."
Numerous
perceived concerns regarding the safety of GM foods have been
aired, many of them speculative and without any scientific
evidence, but three substantial concerns which have been most
widely discussed are in fact urban myths. These are the
L-tryptophan story, the brazil nut allergen story and the events
surrounding Arpad Pusztai and his potato experiment.
The
L-tryptophan story
A
frequently repeated account alleges GM as the cause of the
disease that caused 1500 illnesses and 37 deaths in USA in 1989.
The story refers to the so-called Eosinophilia-Myalgia Syndrome
(EMS syndrome) associated with some dietary supplements
containing the amino acid L-tryptophan.
The
illnesses and death did occur, but the rest of the story is
untrue. In reality, extensive investigation traced the cause to
an impurity in L-tryptophan made by just one of its several
chemical manufacturers, all in Japan. The culprit was Showa
Denko KK of Tokyo (the fourth largest chemical manufacturer in
Japan,
but which had some 80% of the market for L-tryptophan). There
has been successful litigation by three plaintiffs against SD
KK. The GM issue was not raised seriously by the plaintiffs
because there was such overwhelming evidence against it being a
factor.
The
manufacture of L-tryptophan is by a fermentation which also
results in the formation of a number of secondary substances. To
produce L-tryptophan of a purity necessary for human ingestion,
the fermentation product mixture has to go through purification
processes to remove the impurities, by-products and cellular
debris, including treatment with activated carbon and reverse
osmosis. Investigation of the records of Showa Denko KK showed
that in the critical period (December 1988 to June 1989) they
made a number of simultaneous changes to the manufacturing
protocols . One of these was the use of the fermentation
organism Bacillus amyloliquefaciens that had been
genetically altered to increase the production of L-tryptophan.
But this was accompanied by the partial bypassing of the reverse
osmosis purification procedure, and a halving of the amount of
activated carbon used (both stupid and irresponsible things to
have done), thus failing to carry out the purification
effectively. Subsequent research showed that in consequence the
procedure left behind some sixty impurities; and also found
significant correlation between the development of
EMS
and the reduction of the activated charcoal.
There
have been several attempts to explain the precise mechanism by
which the syndrome occurred. One involves a residual impurity
1,1 '- ethylidenebis-[tryptophan] (EBT), which then broke down
to give 1-methyl-l,2,3,4-tetrahydro-beta-carboline-3-carboxylic
acid (MTCA), a substance that was thought to have been involved
in the EMS syndrome. Another suggests that it was the result of
a reaction between two (or more) impurities. Like so many food
poisoning outbreaks investigated after the event, the exact
mechanism is unlikely now to be conclusively proved, but it was
nothing to do with GM. Thus the "tryptophan" story was not a
consequence of GM, nor of tryptophan itself, but an impurity or
impurities left in as a result of irresponsible short-cutting by
a particular chemical manufacturer.
The
brazil nut allergen story
With the
currently much greater recognition of food allergens as a food
safety issue, the possible introduction of allergenicity by
genetic modification is a concern; and the apocryphal story of
"people made sick by a brazil nut gene transferred into soya"
has become a widely believed urban myth.
In fact,
such a product never came on the market, and nobody ever ate any
such product. Soya protein is deficient in methionine, and a
seed company, Pioneer Hi-Bred, wanted to investigate the
possibility of producing a soyabean with increased methionine
content (thereby improving the nutritional quality of soya
protein), by transferring a
brazil
nut gene to soya. With any research involving any gene transfer,
it is routine standard procedure to investigate whether any
allergenicity could be thereby transferred. In this instance,
many people are allergic (some very seriously so) to soya
itself; but it was important to investigate whether such a
transfer would make the resulting soya allergenic also to people
who were allergic to brazil nuts. The research was carried out
at the University of Nebraska, the leading centre for
allergenicity research. Perhaps not surprisingly, the
researchers found that brazil nut allergenicity was transferred
to the experimental material. Pioneer Hi-Bred announced that the
research project was discontinued, and the results were
published in a peer-reviewed journal [Nordlee et al, (1995)].
The
Pusztai potato experiment
This has
received considerable publicity. It relates to the purported
adverse effects on rats of GM potatoes in which lectins had been
inserted, and the associated TV programme and media interviews
given by Dr Pusztai. Lectins, which are complex plant proteins,
appear to act as pest deterrents in plants and lectin insertion
into a crop plant by GM has been investigated as a means of
enhancing pest resistance.
The
story has been greatly confused by contradictory reports as to
exactly what happened, and as to the supposed ill-treatment of
the researcher concerned – mostly culled from the media and
claims by Pusztai himself and activists keen to exploit the
situation. Fortunately there is now a first-hand history
available. In March/April 1999 the House of Commons
Parliamentary Select Committee on Science and Technology
investigated GM, and on Monday 8 March 1999 they held a Hearing
at which Dr Pusztai and his friend Dr Stanley Ewen, and
Professor Philip James, Director and Dr Andrew Chesson, Head of
the Nutritional Chemistry Unit, both of the Rowett Research
Institute (RRI), all appeared and were examined.
The written
statement submitted by the RRI, which, incidentally, is
considerably sympathetic to Pusztai, gives a first-hand
historical account (and, incidentally, disposes of the various
myths that have been put around about Pusztai and his
treatment). For a verbatim account of all the evidence submitted
by RRI and by Pusztai himself, and for the Select Committee's
conclusions, see UK House of Commons, Select Committee on
Science and Technology,
http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/9030801.htm
and
http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/28602.htm
The
study which caused the controversy has since been reviewed twice
by the Audit Committee, by the Royal Society; by ACNFP; by the
Committee on Toxicity; and by the Nuffield Council on Bioethics.
All have found the experiment flawed, poorly designed, and
incapable of leading to meaningful conclusions.. There is,
however, agreement that adequate in vivo tests
need to be developed before a new GM crop with a lectin insert
is released for either human or animal consumption.
As the
RRI Audit Committee stated
"The
research was preliminary and not part of the process of testing
specifically genetically modified crops destined for commercial
use."
"However, the purpose of the research remains valid. It was part
of a larger programme designed to identify possible candidate
genes, and their implications, for possible future use in the
genetic modification of crops to enhance the crops' resistance
to pests."
Whilst
investigations into this case have shown that the problems were
not directly related to the genetic modification as originally
claimed (and still perpetuated by some) they emphasise that a
greater awareness of the possible areas of concern is needed
when assessing the safety of GM foods.
Environmental considerations
Early
regulatory controls over the release of GM crops had, of
necessity, been developed on an ad hoc basis due to the
virtual absence in the 1980s of quantitative data on the ability
of GM organisms to survive in the environment. However, in
recent years evidence has accumulated so that regulations and
guidelines can now be developed on a more rational basis; but
there is a continuing need for studies on the possible risks of
GM crops to the agricultural environment In the last few years,
the UK Government has responded to this need by funding over 20
projects in this area at a cost of over £6 million. Clearly,
regulations will need continuous revision and updating as new
data become available.
In the
EU Member States, any release of GMOs into the environment is
governed by national regulations implementing EU Directive
90/220/EEC (now superseded by Directive 2001/18/EC) (implemented
in the UK as part of the Environment Protection Act). In the UK,
at present there are no GM crops being commercially grown. An
experimental release, such as a field trial of a food crop,
requires consent from the Government. Applications for consent
must include a considerable volume of data and a detailed
assessment of the risk of harm to human health and the
environment. If a risk is identified or there is some
uncertainty about the level of risk, the applicant may propose
measures to manage or eliminate the risk. The applications are
scrutinised by the Advisory Committee on Releases into the
Environment (ACRE), a group of independent experts who advise
the Government on whether consent should be given and whether
extra conditions should be imposed prior to giving consent. All
releases are advertised locally and details are made available
via a Public Register. Release sites are subject to inspection
by the Health and Safety Inspectorate and those making the
release are required to report any incidents that may occur
during and after the completion of the trials. On the one hand
this openness and transparency is admirable, but on the other
hand the public information has been seized on by organised
gangs of terrorist activists who invade and destroy the trials.
The EU
objective has been to protect health and the environment when
- carrying
out the deliberate release into the environment of GMOs for
any purposes other than placing on the market within the
European Community
- placing
on the market GMOs as, or in, products within the European
Community
Data
required other than for higher plants:
1.
Information relating to the GMO
characteristics of donor, recipient (or where appropriate
parental) organisms characteristics of vector characteristics of
modified organism
2.
Information relating to the
conditions of release and receiving environment information on
the release information on the environment
3.
Information relating to the
interactions between the GMO and the environment characteristics
affecting survival, multiplication and dispersal interactions
with the environment
4.
Information on monitoring,
control, waste treatment and emergency response plans.
Data
required for GM higher plants:
1.
Information relating to recipient
and / or parental plant
2.
Information relating to the
genetic modification
3.
Information relating to the GM
plant
4.
Information relating to the site
of release
5.
Information relating to the
release
6.
Information on control,
monitoring, post-release and waste treatment plans
Since 1987,
more than 25,000 field trials of GM plants have been carried out
in 45 countries without adverse environmental consequences.
Furthermore, the rate of field-testing has increased rapidly
especially in the USA where the number of trials has doubled
each year since 1987. In terms of field releases, the European
Union lags well behind
North America. More than 70% of field trials were conducted in the
USA and
Canada followed in descending order by Europe, Latin America and
Asia, with very few trials conducted in Africa. These trials
represent considerable accumulated evidence in support of a
favourable safety and environmental record for the new gene
technology.
However,
the relevance of environmental data obtained from small field
trials to large-scale sowing on several million acres of land
has been questioned. More than 80 GM variants of several food
crops including maize, rapeseed and soyabean have received
regulatory approval in the USA and Canada for large-scale sowing
and use in foods. From data collected by James (1998-2001) and
summarized by Thompson (2003) the estimated global area of GM
crops for 2001 was 52.6 million hectares grown by 5.5 million
farmers in 13 countries. The increase in area between 2000 and
2001 was 19%, almost twice the corresponding increase between
1999 and 2000. The largest acreage of land planted with GM crops
has been in USA and Argentina, although plantings in China and
Canada have also been significant. More than one quarter of the
GM crop area in 2001 was grown in six developing countries. The
number of farmers that grew GM crops increased from 3.5 million
in 2000 to 5.5 million in 2001. More than three-quarters of
these farmers were resource-poor planting Bt cotton (i.e. crops
with effective insect resistance owing to the introduction of
the Bacillus thuringiensis (Bt) gene encoding an
insect-specific toxin), mainly in China, but also in South
Africa.
Past
experience with introductions of new species to environments
where they are not naturally present has shown that potential
problems may take several generations to manifest themselves.
Possible cross-pollination from GM crops to non-GM crops is of
concern to organic farmers, who fear that, if it occurs, their
produce could no longer be said to be "organic", and to those
who wish to have the right to choose non-GM foods. There is also
concern that traits such as herbicide resistance may spread to
wild "relative" weeds (at present the only GM crops that have
wild "relatives" are canola and squash) and that the problem of
insect resistance may be aggravated. It has been suggested that
the adoption of insect-resistant crops by farmers worldwide may
lead to the extinction of certain insect species (e.g.
Lepidoptera) thereby reducing the biodiversity of the planet.
Environmental regulation is difficult to enforce when there are
no clear standards against which the performance of a product
can be measured (e.g. how many birds, butterflies and wild
flowers should there be on a farm and to what extent can their
numbers be affected before the environment is harmed?).
Concern has been expressed about
the potential risk of GM crops hybridizing (i.e. sharing their
genes) with wild closely related species and thereby creating
herbicide resistant weeds. This has certainly happened with
conventional crops but there is no evidence of it having
occurred with GM crops. According to Rick Roush, director of the
University of California Statewide Integrated Pest Management
Program, reviewing the book "Dangerous Liaisons: When Cultivated
Plants Mate with their Wild Relatives" by Norman C. Ellstrand
Nature (Book Review) 427, 395 - 396; Jan. 29 2004) :
"Ellstrand
provides an introductory section for readers who are not
population geneticists, before detailing hybridization between
domesticated plants and their wild relatives, and then
presenting his interpretation of these observations. Despite his
effort to provide this broad context for hybridization between
crops and wild plants, and its consequences, I suspect that most
readers will focus on chapter 7, where Ellstrand contrasts his
views with an opening quote from the Israeli plant scientist
Jonny Gressel: "Most crops have no interbreeding relatives in
most of the world." Ellstrand reviewed the data for the world's
25 most widely planted crops, summarized their interbreeding
with wild plants in a single table, and showed that 22 of them
do hybridize with wild relatives somewhere in the world. I
suspect that this table will be the most widely referenced in
the book, and wish that a few of the distributions were more
precisely stated. For example, cotton, beans and potatoes are
listed with a "multicontinental" distribution of hybridization;
more precisely this refers to Latin America (and, for cotton,
some islands in the Caribbean and Pacific). But what about Gressel's proposition, especially in the
context of GM crops? Using statistics from the database of the
Food and Agriculture Organization of the United Nations, cited
by Ellstrand
http://fao.apps.org, I checked on the dominant GM crops. At
least 87% of the world's soybean crop, and 95% of the world's
maize and cotton, are grown in countries for which Ellstrand
lists no hybridization — and even for those countries with
hybridization, such as China for soybeans, wild relatives are
found in only some areas. Many of the other crops are
complicated to tabulate, but Gressel seems to be correct that
most crops are not interbreeding locally with wild relatives.
This still leaves the possibility that serious problems could
arise in the few areas of the world where hybridization can
occur. This currently seems possible for GM canola in
Canada and the United States, and
for transgenic maize that is probably growing illegally in
Mexico (but has apparently escaped documentation in the refereed
literature). But even after reading this book, I haven't seen
any evidence of harm to human health or to the environment
(including weediness) from such hybridization. Where are the
super-weeds that were predicted to occur from the exchange of
transgenes with wild relatives? In contrast to the lack of
evidence for deleterious effects of gene flow from GM crops,
there is evidence that conventional agriculture has adversely
affected wild plants through genetic swamping of their
populations, and that wild plants have generated weediness in
crop--weed hybrids. As noted by Ellstrand, "problems associated
with hybridization between conventional crops and their wild
relatives received scant attention until potential gene-flow
problems were described for transgenic crops". For example,
hybridization with cultivated rice has been implicated in the
near-extinction of an endemic Taiwanese wild rice. Hybridization
of maize with its ancestor teosinte may be contributing to the
extinction of teosinte populations. Indigenous cotton in the
Galapagos Islands could be at risk of extinction or replacement
as a result of hybridization with cultivated cotton. Ellstrand
cites similar evidence for at least another nine species. He
also documents in great detail the history of sugar beets in
Europe, where hybrids between cultivated beets and their
progenitors, the sea beets, have caused major weed problems."
However, the problem of gene flow,
whether from GM to non-GM (or vive versa) or from hybridization
of conventional crops with wild relatives may well be solved by
-- genetic modification! The February 2004 issue of The
Scientist
http://www.the-scientist.com/yr2004/feb/tech_040216.html
contains a report by Ivan Oransky as follows (courtesy of Henry
Daniell):
Self-Containment for GM Plants
Genetically
engineered plants pose several major environmental concerns,
according to Henry Daniell, a professor of molecular biology and
microbiology at the University of Central Florida. When foreign
genes are introduced into the nuclear genome, they end up in
pollen, posing the risk of transfer to other species. And
sometimes, expression levels are low.
Daniell and
colleagues have come up with what he says is a solution:
chloroplast genetic engineering. The method--the recipient of
several patents, most recently US #6,680,426--offers two
benefits, says Daniell. First, like mitochondria, chloroplast
genes are maternal and therefore not passed through pollen. And
because each cell has 10,000 copies of the chloroplast genome,
expression levels are generally high. "This is absolutely a
beautiful system," he says.
The transgene
construct is designed to minimize disruption of the chloroplast
genome. The gene to be inserted is put under the control of
chloroplast regulatory signals so that errant transgenes won't
express in the nucleus, Daniell says. Those that do hit their
mark in the chloroplasts integrate via homologous recombination
into a non-coding spacer region, where, Daniell says, "they
won't disrupt anything else." Gene delivery is achieved via a
biolisitic "gene gun."
From there, it's
typical transgenic manipulation--selection of cells that have
modified chloroplasts, followed by testing the construct's
maternal inheritance. Daniell has founded a company, Chlorogen,
to license the method.
-The US
National Academies of Science, National Research Council on
January 20 2004 issued a report about a study of methods of
preventing GM plants from mating or spreading novel genes to
other species, entitled "Biological Confinement of Genetically
Engineered Organisms". The report " ... will look at how
biological techniques such as sterilization can be used to keep
transgenic plants and animals from mating or competing with wild
relatives, or from spreading novel genes to other species ..."
The study is sponsored by USDA. and is expected to be completed
around mid-2005.
In the
UK, English Nature (the Government's statutory adviser on
wildlife and natural features) monitors developments which may
affect wildlife and advises on how any damaging effects might be
avoided. Its environmental concerns about GM crops were among
those which led the UK Government to approve the holding of the
UK Farm Scale Evaluations (FSEs) of GM crops and to delay
commercial introduction of genetically modified herbicide
tolerant (GMHT) and insect resistant (IR) crops until research
was completed and the results assimilated.
On 17
January 2002, the UK Government responded to a Report issued by
the UK Agriculture and Environment Biotechnology Commission
(AEBC), entitled: "Crops on Trial," dealing with the FSEs, which
was issued on 10 September 2001.
AEBC includes a range of interests from all sides of the GM
debate and has heard evidence from the public, politicians,
farming and industry groups, non-governmental organisations and
technical experts. Its report comprised a detailed analysis of
the context in which the FSEs were being conducted as well as a
thorough consideration of the issues raised by the intense
interest in the evaluations, resulting in a list of
recommendations regarding future decision-making. Its report is
accessible on-line at
http://www.aebc.gov.uk/aebc/reports.html
In its response the UK Government undertook a public debate on
Agricultural Biotechnology before commercialization of GM crops
will be allowed, and asked the AEBC to provide further advice
how and when to promote an effective public debate on possible
commercialisation of the FSE crops, and how to make best use of
the results of such a debate. The advice should also cover how
to determine the public acceptability of GM crops, in
particular, cross-pollination thresholds and GM presence in
organic crops. This AEBC report was issued on 26 April 2002
http://www.aebc.gov.uk/aebc/public_attitudes_advice.html
The Statement of the UK Prime Minister on the AEBC report is
available on-line at:
http://www.number-10.gov.uk/output/Page5763.asp.
The
response of the UK Government involved three components. These
were: a public debate; a review of the scientific issues
relating to GM; and a study into the overall costs and benefits
of GM crops to be carried out by the Prime Minister's strategy
Unit. The UK Government accepted the AEBC's recommendation for a
steering board, independent of Government, to oversee the
debate, and invited Professor Malcolm Grant, the chairman of the
AEBC, to head this board and to appoint other members, including
others from the NGO community, the biotechnology industry, the
health professions, consumer organisations, as well as
individuals involved in the scientific and economic research.
The GM
Science Review
- the Science
Review panel's first report was published on 21 July 2003 and is
available at
www.gmsciencedebate.org.uk/report/default.htm. The panel met
during October 2003 to look at any relevant issues arising from
the public debate report and also the first set of results from
the Farm Scale Evaluations (see below). On January 22 2004 it
released its second and final report, completing " ... the
independent review of current scientific knowledge on GM crops
and foods ..." In releasing the report, the panel noted that:
" ... The
second phase of the expert panel's work has considered the
report of the public debate, new scientific developments since
the first report including the Farm Scale Evaluation (FSE)
results, and feedback on the first report. Today's report has
clarified a number of points and explores some issues in more
detail but has not altered the first report's original findings.
The first report found no scientific case for ruling out all GM
crops and their products, but nor did it give blanket approval.
It addressed the general characteristics of GM, but emphasised
that GM is not a single homogeneous technology and its
applications should be considered on a case-by-case basis. The
second phase of the GM Science Review found that: none of the
new research published since the first Report significantly
altered the earlier conclusions; the FSEs were of high
scientific calibre. The panel found that if GM herbicide
tolerant crops are managed as in the FSEs, a significant
reduction would be expected in weeds with GMHT beet and spring
oilseed rape, whereas the opposite would be found with maize.
These effects arise from the herbicides and are not a direct
consequence of the GM process. The different findings for
different GM crops reinforced the conclusion of the first
Science Review that GM crops must be assessed on a case-by-case
basis; and the first report covered the issues raised by the
Public Debate Report: 'GM Nation?' and the foundation discussion
workshops provided a useful framework for the Science Review.
The Science Review Panel's conclusions on FSEs were released in
advance of the second report so they could be submitted to the
Advisory Committee on Releases to the Environment (ACRE) for
consideration before they put their advice to Government ... The
GM Science Review was requested by the Secretary of State for
Environment Food and Rural Affairs with the agreement of
Ministers in the devolved administrations. The Public Debate "GM
Nation?" and the Strategy Unit report on the costs and benefits
of GM crops have been the other strands in the GM dialogue aimed
at engaging the public and assisting the Government with future
GM policy decisions ... "
The full Science Review (including
the first and second report), full list of panel members and
more information is available at
http://www.gmsciencedebate.org.uk The 22 January 2004 panel
news release is available at
http://www.gmsciencedebate.org.uk/background/pn220104.htm
Costs
and Benefits Review
- The study by the UK Government's Strategy Unit looking into
the overall costs and benefits of GM crops. The report
'Fieldwork; weighing up the costs and benefits of GM crops' was
published on 11 July 2003 and can be accessed at
www.number-10.gov.uk/su/gm/index.htm.
The
Public Debate
- As a contribution towards the public debate, and as a result
of consumer research carried out, a report was issued the UK
Food Standards Agency on UK Consumer Attitudes toward GM was
issued. A key finding was summed up as
"most
consumers do not have entrenched views (either pro or anti) on
GM food, but there is a suspicion of GM, and there is a lack of
readily understood information".
The full
report is at
http://www.foodstandards.gov.uk/multimedia/pdfs/gm_rep.pdf
The
remainder of the public debate involved some DEFRA-organised
public meetings in several centres, plus many meetings organised
by local groups, and an official Website
http://www.gmnation.org.uk/. On 24 September 2003 the Report
on the results of the public debate were announced. The
Executive Summary can be accessed at
http://www.gmnation.org.uk/ut_09/ut_9_6.htm#summary and the
full Report can be accessed at
http://www.gmnation.org.uk/docs/GMNation_FinalReport.pdf. It
was not the purpose of the Report to say whether the public were
right or wrong about any GM issue, even on matters of fact, but
merely to report on public attitudes revealed. It identified
seven key messages about public attitudes:
- people
are generally uneasy about GM;
- the more
people engage in GM issues, the harder their attitudes and
more intense their concerns;
- there is
little support for early commercialisation;
- there is
widespread mistrust of Government and multi-national
companies;
- there is
a broad desire to know more and for further research to be
done;
-
developing countries have special interests;
- the
debate was welcomed and valued.
Although
a large number of people took part (some 37,000 including
attenders at some 600 meetings, people completing questionnaires
and senders of e-mail and text messages etc), they were entirely
self-selected. The four years of intensive anti-GM
indoctrination to which the UK public had been subjected was
ongoing during the public debate; responses were heavily
orchestrated by activist groups, and open meetings in the public
debate were either organised by, or subjected to campaigning
tactics by, anti-GM activists, leading to complaints from other
members of the public that discussions have been compromised.
Reported in The Guardian newspaper on 25 September 2003,
One leading
British expatriate scientist said antipathy to GM science in
Britain was so bad he would not consider coming home. Having
left Royal Holloway University in
London in 1988, Richard Dixon is
now the director of plant biology at the Noble Foundation in
Oklahoma. "There is far more suspicion of scientists in the UK.
I can give a talk at a town hall meeting here and talk about how
we want to genetically modify crops and get a really warm
response. But when I went to a GM town hall meeting in York a
couple of months ago, I nearly got lynched," he said.'
With all
that, and a self-selected group of respondents, it was entirely
predictable that the findings would be far more hostile to GM
than those of the consumer research carried out by the Food
Standards Agency. Thus the public debate Report found that more
than half of all participants said they were opposed to the
growing of GM crops under any circumstances. The vast majority
(86%) of participants said they did not want to eat GM food,
while only 2% said they would be happy to eat it.
The UK
Government was also waiting for two further key inputs to help
inform its policy-making on GM:, namely
Farm
Scale Evaluations (FSE) of herbicide-tolerant crops, three of
the four FSEs of GM crops. In 1998, four genetically modified
crops had cleared most of the regulatory hurdles before
commercial growing could be allowed in the UK. While these crops
had been assessed as safe in terms of human health and direct
impacts upon the environment, there had been insufficient
research to determine whether there might be any significant
effects on farmland wildlife resulting from the way that the
crops would be managed. The FSEs of these GMHT crops were
established to bridge this important gap in our knowledge. The
results for the three spring-sown crops were due to be published
on 16 October 2003 and would then be considered by the Advisory
Committee on Releases to the Environment (ACRE), would will
provide independent advice to Ministers; and
A
Report from the Agriculture and Environment Biotechnology
Commission (AEBC) on the coexistence of GM and non-GM crops.,
involving ideas for possible co-existence measures, such as
crop separation distances, and also looking at questions of
liability. An overriding consideration is that decisions on
whether individual GM crops can be grown commercially are
subject to collective European Union agreement.
The results of three FSEs were
issued on 16 October 2003. The presentations, by the authors, of
the eight rigorously peer-reviewed research papers on the three
spring-sown FSEs, between them constituting a huge, rigorously
designed, rigorously conducted, epoch-making GM research project
costing nearly six million pounds sterling. In their
presentations the authors were at pains to point out that their
findings did not relate to the fact that the GM herbicide
tolerant (GMHT) crops were GM, but to the differing herbicides
and herbicide management systems that accompanied the GM crops
and the conventional crop controls respectively.
The
eight research papers present the FSE findings for those spring
sown crops (namely beet, maize and spring oilseed rape). The
winter oilseed rape FSE will not be reported until later in
2004. They analyse the effect of each crops and accompanying
herbicide and herbicide management system on the plants and
animals living in the vicinity. About 60 fields in different
parts of the UK where these crops were normally grown, each were
sown with beet, maize and spring oilseed rape. Each field was
split, one half being sown with a conventional variety managed
according to the farmer's normal practice, the other half being
sown with a GMHT variety, with weeds controlled by a
broad-spectrum herbicide (glufosinate-ammonium in maize and
spring oilseed rape, and glyphosate in beet). There was
stringent auditing of the farmers' adherence to the protocols.
Comparisons in biodiversity were made by looking at the levels
of weeds and invertebrates, such as beetles, butterflies and
bees, in both the fields and the field margins immediately
surrounding them. The results, which until 16 October have been
a closely guarded secret, will be studied by scientists,
farmers, food companies and governments around the world. and
they reveal significant differences in the effect on
biodiversity when managing GMHT crops as compared to
conventional varieties.
Predictably, activists of one sort or another, and the media,
have been interpreting the results to fit in with their
respective preconceived positions. For the scientist, the
outcomes point to the importance of weeds and of soil seed-banks
in sustaining farmland wild life. It has been axiomatic that
with the present generation of GMHT crops that the purpose was
to get rid of weeds as thoroughly and effectively as possible
with the minimum of labour and tillage and with minimum
application (in quantity and frequency) of a relatively
environmentally-friendly broad-spectrum herbicide. Purely from a
farmland wild live aspect, it could be argued that in two of the
three crops (beet and spring oilseed rape) the herbicides
performed their function too well. These results seem to suggest
that there is a case for organizing the provision of sufficient
weeds to maintain the farmland wild life.
Put
another way, a rational society wishing to take advantage of the
agricultural benefits that each of these GMHT crop systems can
provide would recognize the need for a trade-off, to establish
for each crop and herbicide management system a point of
equilibrium where the benefits can accrue alongside the
sustaining of the farmland "natural communities".
Whilst
the findings cannot answer all the questions resulting from the
intense public interest and debate on the future of genetic
modification in agriculture in the UK, they do provide a
valuable model for the assessment of technological change. The
FSEs also demonstrate that it is possible to design experiments
at an adequate scale to help forecast the potential
environmental impacts of new technologies and practices in
agriculture - something that has never been done before.
On 13
January 2004 ACRE gave its verdict on the FSEs. The Committee
noted that in the cases of beet and spring-sown oilseed rape
FSEs, evidence showed that insect species and weeds declined in
the trial areas, endangering birds that fed on them. However, it
supported the growing of GM maize, saying it was better for the
environment than conventional farming. It also suggested the
other crops might be grown in future if measures were taken to
protect wildlife.
Although
the UK Government subsequently approved in principle the
growing of the GM maize for animal feed, the approval was
heavily hedged around with onerous conditions (including a four
years repeat of the FSE trial but with a non-atrazine control).
The company concerned (Bayer CropScience) regarded it as totally
impracticable and “economically non-viable and withdrew.
On 1 July
2004 it was announced that Syngenta, the last big biotechnology
company working on GM crops in
Britain,
is to close its research facility in the
UK
and transfer its efforts to the United States.
Socio-economic aspects
Much of
the vocal antagonism to GM expressed by its opponents appears to
consist of ideological antipathy to large companies engaged in
GM and to the socio-economic system which allows large companies
to exist and thrive. This is, however, not specific to GM, for
similar antipathy by the same groups is expressed about large
companies engaged in other products and activities. A great deal
has been said and written to the effect that the existence of GM
seeds somehow denies the farmer the ability to practice in the
traditional way -- as though farmers cannot choose whether to
use GM seed or stick with non-GM.
One
manifestation of this concern has been about the potential for
misuse of the so-called terminator genes which prevent seeds
from germinating. Although patents exist for terminator
technology, it is not available commercially. There are fears
that large corporations might use such genes in all their GM
crops to prevent farmers from storing seed and that plants that
produce barren seed could make life more difficult for poor
farmers in the developing world. However, farmers would only buy
these seeds if they found an overall advantage in doing so;
otherwise they could continue to grow conventional cultivars and
save the seed in the traditional way. Furthermore, some fear
that if cross-pollination occurs, GM plants with terminator
genes could transfer their sterility to other plants grown
nearby. However, on the positive side, terminator technology
could ensure that GM plants do not themselves become weeds.
Concerns
have been expressed over the supposed problem of patents held
by biotechnology companies preventing the use of beneficial GM
crops in developing countries. Leaving aside the strange
contradiction that these concerns are expressed in many cases
by the same people who deny that there are GM benefits and
leaving aside too that many of the original patents are already
expiring, the fact is that today, over five million
resource-poor farmers in South Africa, China, India, the
Philippines and elsewhere already happily grow nearly one-third
of the world’s total GM hectarage because they have higher
yields, require fewer inputs and raise income.
The
classic case is GM vitamin A rich golden rice developed by Ingo
Potrykus (referred to earlier) and his colleague Peter Beyer .
Here the research has involved the use of over 70 patents owned
by biotechnology companies. from whom they had to obtain
permission before they could begin testing the golden rice in
field trials. What the critics fail to mention, however, is that
those patent holders granted Potrykus and Beyer exemptions for
Golden Rice; and moreover have agreed to provide free licences
for use by poor farmers in developing countries.
At the 12th
World Congress of Food Science and Technology in Chicago in July
2003, Potrykus stated, in the course of a comprehensive
presentation, that obtaining those exemptions was
time-consuming, but the main reason why golden rice and other GM
nutrient-enhanced crops have not yet begun to help resource-poor
farmers is not patents but "regulatory obstacles based on undue
paranoia." He has even argued that "those who oppose GM
technologies for political advantage or self-interest [should
be] held responsible for the unnecessary suffering of millions
of people with vitamin A deficiency," which golden rice could
help address. His most up-to-date presentation (April 2004) is
at
http://www.agbioworld.org/biotech_info/articles/potrykus.html
A wider
matter, however, involves the general question of patents in
relation to GM, and, more particularly whether genes can or
should be patentable. By analogy with computer language, the
procedure of inserting a gene into an organism is not just
"cut-and-paste" but "cut- copy (billions of times
over)-and-paste". The laboratory-generated copies by that
procedure are in every way exact copies of the copied original,
but are not the original. Precise details of patent law vary
from country to country, but in principle, patents are intended
to protect inventions and give the inventor monopoly for a
limited time to benefit from the invention. Whether it is the
original gene or DNA fragment, or a lab-generated exact copy,
these are not "inventions" and ought not to be patentable. A
gene is a pre-existing thing, and identification of a gene and
its function is a "discovery" rather than an "invention".
However, an invention is often a novel combination of
pre-existing things, and it is not those things but the
combination of them which may be accepted as an invention and
therefore patentable. Generally, patent law requires novelty and
also that the novelty and its claimed benefits would not be
obvious to those "skilled in the art". If these principles are
valid, then someone inventing a novel combination involving a
gene can patent the combination, but cannot use patent law to
prevent someone else from using that gene for other purposes (or
even patenting a different combination involving that gene).
Ethical considerations
The
officially appointed UK Committee on the Ethics of Genetic
Modification and Food Use, chaired by the Rev. John
Polkinghorne, carried out a wide public consultation and issued
a report in September 1993 on all of the moral and ethical
issues involved. This was accepted by the UK Government and
welcomed by the Institute of Food Science & Technology. The
Committee found that the concerns were misconceptions rather
than of real substance, arising from lack of knowledge, outside
the scientific community, of just what was involved.
The
Committee pointed out that because any gene extracted from one
species for copying into another, is not itself inserted but is
copied in the laboratory and diluted millions of times before a
single gene is transferred, the chance that the original gene
would be found are much less than the chance of recovering a
particular drop of water from all the oceans of the world. If
this were widely understood fears of cannibalism or of
contravening religious food taboos would be seen to be
unwarranted. Unfortunately, this fact does not make good media
copy, whereas sensational stories do.
The Polkinghorne Committee's
conclusions were:
genetic modification of food and medicines is here to stay. It
is not something to be stopped, and it would not be ethically
right or necessary that it should be;
there
is no reason for any ban on the use of copy genes of human
origin or from animals subject to dietary restrictions, but
scientists working in this field should be discouraged from
using such genes where alternatives would be equally effective;
products containing such copy genes should be labelled to
enabled consumers to make informed choices;
government and industry should look for ways of explaining
genetic modification to the general public.
Because
what is transferred to the "host" is not the DNA direct from the
donor but a laboratory copy of it (in familiar terms, it is
cut-copy (billions of times over)-and-paste rather than
cut-and-paste) the perceived concerns are mistaken, but no less
real for that.
As a
matter of interest that not many people realise, we are in fact
all cannibals - everyone is continuously shedding skin cells,
which of course contain their DNA. We are all ingesting the DNA
of people around us, or who, for example, have previously been
in the same room or public transport.
It is
noticeable that when "ethical aspects" of GM are raised it is
mostly in terms of ethical objections. However, two major
reports have included addressing the ethical and social
imperatives involved in making the potential benefits of GM
available to improve the present and future food supply,
especially in developing countries.
A most
thorough and balanced study of the ethics, environmental impacts
and social aspects of GM was carried out in 1998 under the
auspices of the Nuffield Foundation. The Nuffield Council on
Bioethics carried out a widespread public consultation using a
questionnaire posing the ethical, environmental and social
issues and issued a comprehensive report on its conclusions and
recommendations, "Genetically modified crops: the ethical and
social issues".
http://www.nuffield.org/fileLibrary/pdf/gmcrop.pdf
In June
2003 the Nuffield Council on Bioethics issued for public
consultation a Discussion Paper on the use of GM in developing
countries. This evoked a supportive response from IFST.
Following the consultation, on 28 December 2003 the Nuffield
Council on Bioethics issued its Report (described as a
"Follow-up Discussion Paper") on "The use of genetically
modified crops in developing countries".
http://www.nuffieldbioethics.org/filelibrary/pdf/gm_crops_paper_final.pdf
Information aspects
Information (and particularly label information) about the GM
status of foods or ingredients is a topic with polarised views
that do not lend themselves to an intermediate position. On the
one hand, it is argued that if a food or ingredient has been
approved as "safe", the method of production is irrelevant and
need not be stated.. On the other hand, it is argued that
provision of that information is necessary for informed consumer
choice, including the consumer who wishes to choose GM, and the
consumer who wishes to avoid GM for whatever reason – even an
irrational reason or whim. The EU Commission adopts the latter
position (which is supported by IFST) while the US FDA adopts
the former.
Factors
affecting EU approach to regulating GM
In the
EU, the general legislative approach throughout its existence
has been that if anything can conceivably be regulated, regulate
it. So it had built a comprehensive system and machinery for
considering and approving (or otherwise) applications for
approval of specific lines of GMOs, and for controlling the
release of GMOs into the environment. Likewise, it adopted from
the outset the principle of informed consumer choice, which has
led to increasingly comprehensive measures, initially voluntary
and then by more and more stringent legislation, to provide
distinctive labelling of GM foods. In this, as in other aspects,
the nature and extent of the regulatory provisions has been
influenced by the governments of the Member States, reflecting a
public opinion in turn influenced by activist campaigning.
Differences from the US regulatory approach
In
contrast, in the USA the Food and Drug Administration (FDA) has,
despite increasing pressure, refused to require distinctive
labelling of GM materials, on the grounds that it has determined
that they are substantially equivalent to the non-GM versions;
and that being so, their method of production is irrelevant. The
most comprehensive analysis of the approach and reasoning
underlying the US position is given in the Expert Panel
Report on the Biotechnology of Foods issued by the Institute
of Food Technologists (IFT). The full text is available at
http://www.ift.org/govtrelations/biotech/
The absence
of distinctive labelling in
USA
has had a consequence that most US consumers have not had the
presence of GM foods or ingredients drawn to their attention
(although over the past few years this situation has been
gradually changing). Most of those that have been aware of it,
have evidently been reassured by approval on the part of both
FDA and EPA. This has in turn has been one of the factors making
US consumers much less susceptible (so far) than European
consumers to the kind of activist campaign that has dramatically
affected public opinion in the EU and especially in the UK.
However, a
Public Opinion Poll was recently conducted in New York State for
the Cornell Cooperative Extension's Genetically Engineered
Organisms Public Issues Education (GEO-PIE) Project - The poll "
... found that New York State residents are divided on the use
of biotechnology in food production, with the public almost
evenly split between those who oppose its use, those who favor
it, and those who are undecided ..." Telephone data collection
commenced on
March 10, 2003 and was completed
July 2, 2003.
Details are at <http://www.comm.cornell.edu/msrg/research_news.html
A recent
survey by the Pew Initiative on biotechnology and GM foods
revealed that Americans’ knowledge of GM foods remains low and
their opinions about its safety is just as divided as it was two
years ago. The survey also shows that knowing FDA reviewed and
approved a GM product can increase public confidence and that
public support for GM products decreases as uses of the
technology shift from plants to animals.
Using
data from a similar survey released by the Pew Initiative in
March 2001, the survey was able to compare awareness levels over
a two-year period and draw two major conclusions: Americans’
knowledge about GM foods remains low, even as GM technology is
increasingly applied to agriculture; and opposition to GM foods
has softened somewhat in the last two years but opinions about
safety remain split.
The survey
also probed topics rarely explored in widely-available opinion
polls about agricultural biotechnology, including how Americans
feel about the way GM products are regulated in the
US
and the application of genetic engineering technology to
animals. Key findings indicate that Americans oppose a ban on GM
foods, but are strongly supportive of a regulatory process that
directly involves the FDA. It was also determined that Americans
are far more comfortable with genetic modifications to plants
than animals, and are particularly supportive of genetic
modifications that improve health.
The nationwide survey, conducted
August 5-10,
2003 by The Mellman Group and Public Opinion Strategies,
consisted of telephone interviews of 1,000 American consumers.
The margin of error for this survey is +/- 3.1%. The margin of
error is higher for subgroups. Data from a similar survey,
released by the Pew Initiative in March 2001, was used for
tracking purposes.
The full report is at
http://pewagbiotech.org/research/2003update/
Another
major difference is that, in the definition of substantial
equivalence, still used in many countries including the USA and
Canada, the presence of degraded novel DNA or protein does not
preclude a GM food from being considered substantially
equivalent to a conventional food. However, in the EU, the
concept of substantial equivalence was redefined in December
1997. Only highly processed foods derived from GM crops, such as
highly refined oil, white sugar and starch hydrolysates, are
considered substantially equivalent to their conventional
counterparts on the grounds that neither DNA nor protein would
be expected to be present following the processing that these
foods receive. All other ingredients derived from GM crops, such
as flour and protein extracts, require a full safety evaluation
as they may contain novel DNA and/or protein, in either intact
or degraded form. Thus, lecithin from GM soyabean, used
extensively as an emulsifier in many processed foods, would be
considered substantially equivalent to conventional lecithin in
North America but not in the UK and the rest of the EU..
Detection and analysis of GM materials
Effective
regulatory control over GMOs is crucially dependent on the
existence of reliable analytical methodology for detection and
identification of specific genes, and for quantification where,
for example, a threshold limit is set. Until the mid-1990s, in
the absence of reliable analytical methods it was impossible to
determine whether a food or food ingredient had been genetically
modified. More recently, however, new methods have been
developed based on the polymerase chain reaction (PCR) – a method for several-million-fold amplification in
vitro of specific
DNA sequences known as nucleotides or "primers". Compared with
the millions of bases in the
DNA in an
organism, and 100 bases in an average gene, it has been
discovered that primers as short as 21-24 bases in length can
act as a unique "fingerprint" for a gene.
PCR-based assays involve the following three basic steps:
1. DNA extraction and purification
2. PCR amplification of DNA
3. Gel
electrophoretic analysis of
PCR reaction products
Within
the framework of the development of EU legislation on GMOs in
food and food ingredients, the Health and Consumer Protection
Directorate General of the European Commission in December 1998
commissioned two studies on the development of qualitative as
well as quantitative methods for the detection of GMOs in food,
after an open call for tender procedure (Official Journal S 122
of 27 June 1998, p.34) to two leading institutions in the field
of analytical methods:
4. The
German Federal Institute for Health Protection of Consumers and
Veterinary Medicine (BgVV – Bundesinstitut für gesundheitlichen
Verbraucherschutz und Veterinärmedizin) and;
5. The
Institute for Health and Consumer Protection (IHCP) of the Joint
Research Centre of the European Commission in Ispra.
The studies were completed in
October 2000 and executive summaries can be accessed at
http://europa.eu.int/comm/food/food/biotechnology/gmfood/biotech04_en.pdf
and
http://europa.eu.int/comm/food/food/biotechnology/gmfood/biotech05_en.pdf
Meanwhile,
the World Health Organization on 1 August 2003 announced the
availability of a guidance manual which is " ... used in the
training courses organized jointly by the Joint Research Centre
(JRC) of the European Commission and WHO/Europe, [which]
provides the theoretical and practical information on
methodologies and protocols followed during the courses. It
covers a wide variety of techniques for GMOs detection,
identification, characterization and quantification, and
includes key background theoretical information for working in
the field of GMO detection ..." Details are available at <http://www.euro.who.int/foodsafety/Assistance/20030728_1
The course
is intended to teach molecular detection techniques to
laboratory personnel with a good level of analytical knowledge,
but with no or little expertise in this specific domain. The
Course Manual entitled "The analysis of food samples for the
presence of genetically modified organisms", edited by M.
Querci, M. Jermini and G. Van Den Eede, has now been made
available on-line at
http://gmotraining.jrc.it/
In March
2004 the European Committee for Standardization (CEN) issued
European Standard EN ISO 21572 :2004 “Methods for detection of
Genetically modified organisms and derived products – Protein
based methods”.
EU
Directives and Regulations concerning GM
Relevant
regulatory information has been given under various headings in
the foregoing text, but for convenience is collected under this
heading, and presented in a way which shows the historical
development of the legislation.
Regulations on Novel Foods and Novel Food Ingredients
The
principal legislation is EU Regulation No. 258/97 of the
European Parliament and of the Council of 27 January 1997
concerning novel foods and novel food ingredients. [OJ L43,
14.2.97, pp 1-7]. In the UK the enforcement and execution of
certain provisions of the EU Regulation and set fees for
assessment procedures in the
UK
are provided by:
The
Novel Foods and Novel Food Ingredients Regulations 1997 (SI
1997/1335)
The
Novel Foods and Novel Food Ingredients (Fees) Regulations 1997
(SI 1997/1336)
The Novel Foods Regulation
applies to the placing on the market within the EU of foods and
food ingredients which have not previously been used for human
consumption to a significant degree and which fall into the
following categories:
foods
and food ingredients containing or consisting of GMOs within the
meaning of Directive 90/220/EEC (see below)
foods
and food ingredients produced from, but not containing, GMOs
foods and food ingredients with a new or intentionally modified
primary molecular structure
foods
and food ingredients consisting or isolated from
micro-organisms, fungi or algae
foods
and food ingredients consisting of or isolated from plants and
food ingredients isolated from animals, except for foods and
food ingredients obtained by traditional propagating or breeding
practices and having a history of safe food use
foods
and food ingredients to which has been applied a production
process not currently used, where that process gives rise to
significant changes in the composition or structure of the foods
or food ingredients which affect their nutritional value,
metabolism or level of undesirable substances.
The
novel foods and food ingredients must not present a danger for
the consumer, mislead the consumer or differ from the foods or
food ingredients which they are intended to replace to such an
extent that their normal consumption would be nutritionally
disadvantageous for the consumer. Derogations are available for
foods and food ingredients which according to expert scientific
opinion are substantially equivalent to existing foods in
respect of their composition, nutritional value, metabolism
intended use and level of undesirable substances contained
therein.
These
particular regulations do not apply to GM-derived food
additives, flavourings and extractions solvents. On this basis
soya lecithin derived from GM soya would not have required an
indication that it is derived from GM sources (but see later).
The EU
Novel Foods Regulation also specifies the assessment procedures
which must be carried out before a novel food can be placed on
the market, and makes for provision for objections to be raised
by interested parties. A procedure for re-assessment of novel
foods is included if they subsequently appear to be endangering
human health and for a review of the regulations within 5 years
from implementation in any case.
The
Novel Foods Regulation has been in force for around seven years.
There have been relatively few applications for full approval of
GM food sources or ingredients, some of them by the 'substantial
equivalence' notification route.
The
European Food Safety Authority is now the central body
controlling assessment of novel foods and novel food
ingredients. Applications can be made to a national authority
(in the
UK,
the Advisory Committee on Novel Foods and Processes (ACNFP)).
The findings of a national body, which must be stated within 90
days, are circulated to those of the other Member States, which
have 60 days in which to disagree, failing which approval is
ratified. ACNFP carries out this task in consultation with the
Committee on Toxicity of Chemicals in Food, Consumer Products
and the Environment (COT), the Scientific Advisory Committee on
Nutrition (SACN) (formerly known as the Committee on Medical
Aspects of Food and Nutrition Policy (COMA)) and the Food
Advisory Committee. The ACNFP has the option to assess food
ingredients on a "fast track" route on the grounds of
"substantial equivalence" to existing products or subject them
to a full safety assessment. So far the Committee has concluded
that highly processed, refined foods derived from GM crops such
as hot pressed oil, white sugar and starch would be
substantially equivalent on the grounds that neither DNA nor any
proteins would be expected to be present. However, other
ingredients like flours and protein extracts require a full
safety evaluation because they may contain novel DNA intact or
in a degraded form and protein products denatured to varying
extents.
Releases
into the Environment
Council
Directive 90/220/EEC of 23 April 1990 on the deliberate release
into the environment of genetically modified organisms [OJ L
117, 8 May 1990, p 15; amended by Commission Directive 94/15/EC
(OJ L103, 2214/94, p.20) and Commission Directive 97/35/EC (OJ
L169, 27/6/97, p 72)]. This Directive. is administered in the UK
by the Department of the Environment and implemented in the UK
by the following Regulations
The
Genetically Modified Organisms (Deliberate Release) Regulations
1992 (SI 1992/3280) and
The
Genetically Modified Organisms (Deliberate Release) Regulations
1995 (SI 1995/304)
The
Genetically Modified Organisms (Deliberate Release and Risk
Assessment - Amendment) Regulations 1997 (SI 1997/1900).
Under this
Directive, a manufacturer or importer must submit a notification
to the national competent body of a
Member
State
where the product is to be first placed on the market, before
undertaking a deliberate release into the environment of a GMO,
or placing it on the market.
The
notification should contain a technical dossier of information
including a full risk assessment. The
Member
State
that received the notification examines the dossier and in the
case of a negative evaluation the notification is rejected.
In the
case of a favourable opinion, the dossier is forwarded to the
European Commission and all the competent authorities of the
other Member States who have the right to raise objections. If
there are no objections, the competent authority that carried
out the original evaluation grants the consent for the placing
on the market of the product, which may then be placed on the
market throughout the European Union.
In case of
objections, a decision has to be taken at Community level. The
Commission seeks the opinion of the European Food Safety
Authority before drafting a Decision which is put forward to the
Regulatory Committee composed of representatives of Member
States for favourable opinion. Otherwise a proposal is put
forward to the Council, which decides by qualified majority. If
no Council decision is taken within 3 months the Commission
takes the decision. In any case, in accordance with Directive
90/220/EEC, the Commission is ultimately obliged to adopt measures to
authorise a GMO, if the application fulfils current EU
legislation and if it is not rejected by unanimity in the
Council, or if the Council fails to act within the fixed
deadline.
GMOs
have to undergo a scientific assessment of risks to human health
and the environment before receiving Community authorisation.
Risk assessments are performed on a case by case basis.
The
safety assessment takes into account of the following:
How the
GM was developed - including the source of the genes to be
introduced and detailed molecular analysis of the modified plant
and organism. The process can be likened to that of 'cutting'
and 'pasting' where pieces of DNA are cut out of the donor organism, copied and pasted into a recipient
organism. It is necessary to establish which genes are
incorporated and where in the recipient genome.
Risk
associated with the gene products in the plant, mainly proteins.
It is necessary to know that the gene does not encode for a
protein that is toxic to humans or does not produce an allergic
response. It must also be established that the inserted gene(s)
does not result in unexpected effects.
Investigation of the possibility that the inserted gene may be
transferred to bacteria. This has particular relevance to the
possible transfer of antibiotic resistance genes.
Up to 29
October 2001, under the procedure foreseen in Directive
90/220/EEC and using the current risk assessment methodology,
18 GMOs had been authorised in the EU. Two genetically
modified plants, a variety of soya and a variety of maize were
authorised for use in food. From October 1998 until the present
no further authorisations were granted under Directive 90/220/EEC and as of
29 October
2001, 12 applications for authorisation were pending. The
moratorium continues at this time but (unless blocked by some
Member States) is on track to be lifted following the adoption
of the new Directives.
Council Directive 90/220/EEC has
now been superseded by Directive 2001/18/EC providing for
deliberate release of GMOs into the environment.
Containment
EU
Council Directive 90/219/EEC on the contained use of genetically
modified micro-organisms [OJ L117, 8 May 1990, pp 1-14], as
amended by Council Directive 98/8 1 1EC of 26/10/98 (OJ L330, 5
December 1998, p13). This Directive, which provides the
circumstances and conditions under which GMOs (including
fermentation organisms) require consent for contained use, is
implemented in the UK by:
The
Environmental Protection Act 1990, Part VI, Genetically Modified
Organisms, Sections 106-127. Section 106 states that this Part
(i.e. Part VI) has effect for preventing or minimising any
damage to the environment which may arise from the escape or
release from human control or genetically modified organisms.
The
Genetically Modified Organisms (Risk Assessment) (Records and
Exemptions) Regulations 1996 (SI 1996/1106) restrict the import
and acquisition of GMOs under Section 108 (l)(a) of this Act.
The
Genetically Modified Organisms (Contained Use) Regulations 1992
(SI 1992/32 17)
[The
Genetically Modified Organisms (Contained Use) Regulations 1993
- now revoked]
The
Genetically Modified Organisms (Contained Use) (Amendment)
Regulations 1996 (SI 1996/967)
The
Genetically Modified Organisms (Contained Use) (Amendment)
Regulations 1996 (SI 1998/1548)
Labelling
Prior to
May 1997, labelling of GM foods in many countries, including the
UK, was not explicitly mandatory. Nevertheless, some food
manufacturers and retailers labelled GM foods on a voluntary
basis (e.g. the Co-op's vegetarian cheese prepared using GM
chymosin and Sainsbury's and Safeway's GM tomato puree) to allow
consumers to exercise choice and to gain consumer confidence.
Labelling guidelines developed by a number of bodies including
the independent Food Advisory Committee in 1993 (revised in
1996) and the Institute of Grocery Distribution in 1997. These
guidelines took into account the need for labelling of novel
foods which contain material (e.g. allergens) which may have
implications for the health of some sections of the population
(e.g. infants or the elderly) as well as those which contain
"ethically sensitive genes". The latter include foods that
contain copy genes originally derived from humans or from
animals which are the subject of religious dietary restrictions
(e.g. pig genes for Muslims) or any animal genes for
vegetarians. Much of the provision on ethically sensitive genes
has been based on the findings of the UK Polkinghorne Committee,
which reported on the ethics of genetic modification in 1993.
On 15
May 1997, the EU Novel Foods Regulation (258/97) were made,
controlling the placing on the market and the labelling of GM
foods or foods obtained from GMOs mandatory in the European
Union if, on the basis of a scientific assessment, they were
judged not to be substantially equivalent to an existing food
(for a definition of substantial equivalence, see section above
on "Safety and regulation of GM foods"). Article 8 of the Novel
Foods Regulation requires foods and food ingredients containing
or consisting of GMOs and foods and food ingredients produced
from (but not containing) GMOs to be labelled so as to inform
consumers of any characteristic or property that makes the food
or food ingredient different from an equivalent, existing food
or food ingredient. Not only must the modified characteristic or
property be identified, the method by which it was obtained must
be indicated. The regulation allowed voluntary labelling to
indicate the absence of any genetic material.
However,
specific lines of GM soya and GM maize approved under the
Deliberate Release Directive 90/220, and consumed to a
significant degree before the Novel Foods Regulation came into
effect on 15 May 97, were, therefore, outside the scope of that
Regulation.
To deal
with that situation, on 1 November 1997 a Commission Regulation
1813/97 was adopted which made food ingredients from those crops
subject to the same distinctive labelling provisions as those
contained in the Novel Foods Regulation. This regulation also
stated that detailed Community Rules on labelling would be
adopted as soon as possible in accordance with the requirements
of Article 8 of Regulation 258/97. In line with this provision,
Council Regulation No 1139/98 [OJ L 159, 3/6/98, p4] came into
effect on 1 October 1998. As later amended by Regulation
49/2000, it requires that where a food consists of more than one
ingredient, the words "produced from genetically modified soya"
or "produced from genetically modified maize", as appropriate,
shall appear in the list of ingredients. This wording can be
shortened to "genetically modified" where an ingredient is
already listed as being produced from soya or maize; or where it
is used as a footnote, linked by asterisk to "soya*" or
"maize*". This regulation applies to foods delivered as such to
the final consumer.
EU
Regulation 50/2000 applies similar requirements to the labelling
of GM derived additives and flavourings, but extends beyond GM
soya or maize to any GM source.
In the
UK, this requirement was taken one step further in early 1999 by
the announcement that labelling of GM soya and maize will be
required not only for manufactured products but also in
restaurants, cafes, delicatessens and sandwich shops. Since it
is not always practically possible for catering establishments
to provide labelling at the point of sale, the Food Labelling
(Amendment) Regulations 1999. S.I. 1999/747 (UK) allow such
establishments to inform customers about GM foods via their
staff. The availability of this information must also be
indicated on the menu or on a prominent notice. In addition,
information must also be made available to customers who place
telephone orders for take-away food. The Regulations allowed for
a 6-month lead-in time (i.e. to September 1999) to enable
reprinting of menus and staff training. The selling of foods
containing GM material where this has not been properly declared
can now be prosecuted and fined up to £5,000.
Regulation 1139/98 also requires that validated testing methods
be established so that the presence or absence of GM materials
can be scientifically determined. To deal with adventitious
contamination of foods or food ingredients with GM materials, a
threshold for detection of genetically modified DNA would be set
at or below which foods would not need to be labelled. Provision
for a negative list of processed foods in which any genetically
modified DNA or protein present would have been destroyed was
also to be drawn up under the Regulation. Foods may only be
exempted from distinctive labelling if they contain less than an
agreed threshold level of GM material.
Regulation 49/2000 of 11 January 2000 set the threshold at 1% of
a single ingredient food or, in a multi-ingredient food, 1% of
each ingredient considered separately; but only if the
manufacturer can demonstrate that the ingredient has been
obtained from a non-GM source (but note that this only permits
exemption from distinctive labelling for food or ingredients
below the threshold; it does not permit such foods to be
designated as "GM-free" – however, the EU Commission's program
of future work foreshadowed the development of a Regulation for
the labelling of GM foods). Of course, effective regulatory
control in relation to a threshold limit is crucially dependent
on the existence of a validated reliable analytical method for
detection, identification and quantification of specific genes.
The
original expectation was that the food components compared
should be key nutrients and toxicants rather than tiny fragments
of degraded DNA and associated proteins. The Regulation
recognised that in some cases it would not be possible to
segregate foods which contain genetically modified and
conventional produce (e.g. soyabeans imported from the USA). In
such circumstances, the Regulation recognised that providing
other information for the consumer (e.g. point-of-sale leaflets)
identifying that GMOs may be present fulfilled the labelling
obligation.
Enforcement of these measures has been carried out by Member
States' authorities.
From
July 2000 discussions and work proceeded in the Commission, the
Council of Ministers and the European Parliament, to provide a
new comprehensive and stringent regulatory regime, replacing the
previous piecemeal measures covered in the various pieces of
legislation. This would cover traceability of GMOs throughout
the chain from farm to table, and labelling of GMOs and products
produced from GMOs and regulating GM food and feed.
'Traceability' here means the ability to trace and follow a
food, feed, food-producing animal or substance, through all
stages from rearing or growing of primary products, through
production, manufacture and distribution up to and including its
sale or supply to the final consumer; and in the case of a food
containing a GMO, or a food, food ingredient, additive, or
flavouring derived from a GMO, an unique code identifier
following it from "farm to fork", and provision to the
authorities of information facilitating the detection and
identification of a particular GM product including lodging of a
sample of the GMO or its genetic material.
Of
course traceability is highly important for all aspects of
product food safety. But for any scheme that needs an effective
system for authorization of specific GMOs, and labelling
distinction between GM and non-GM products, not only analysis
but also traceability is a must. However, this was the first
time that a proposal had been made to establish mandatory
traceability measures. Moreover, it would seem that the new
approach placed emphasis on traceability of heritage rather than
relying solely on analysis.
On 27
July 2001 the Commission published the two Proposals for two
Regulations of the European Parliament and of the Council
on
genetically modified food and feed
http://europa.eu.int/comm/food/fs/biotech/biotech08_en.pdf
concerning traceability and labelling of genetically modified
organisms and traceability of food and feed products produced
from genetically modified organisms
http://europa.eu.int/comm/food/fs/biotech/biotech09_en.pdf
On 1 July
2003, the EU Commission issued an updated Questions-and-Answers
fact sheet on the regulation of GMOs in the EU, divided into two
sections; Part A covers legislation in force; Part B covered the
new legislative proposals on traceability and labelling. It can
be found at
http://europa.eu.int/comm/dgs/health_consumer/library/press/press298_en.pdf
On 29
September 2003 the EU Commission issued "Questions and Answers
about GMOs in seeds," which provides answers to the following
questions: What is the EU seeds legislation? Is there separate
legislation on GM seeds? Why is there a need to set thresholds
for GM-impurities in conventional seeds? What thresholds for
GM-presence in conventional seeds will the Commission propose?
What is the aim of such thresholds, what is the relationship
between the seed thresholds and the labelling thresholds for
food and feed products? What kind of GMOs will benefit from the
thresholds proposed? and Will these thresholds be important for
the co-existence of genetically modified crops with conventional
and organic farming? It can be found at
http://europa.eu.int/rapid/start/cgi/guesten.ksh?p_action.gettxt=gt&doc=MEMO/03/186|0|RAPID&lg=EN
As
mentioned earlier, the Commission's proposal placed the European
Food Safety Authority (EFSA), rather than individual
Member
States,
at the centre of the approval process. The EFSA would be
responsible for undertaking a risk assessment covering both
environmental risk and the risk to human and animal health when
assessing a GM food or feed ingredient. In practice, the safety
assessment would be carried out by Member States, on a rota
basis, on behalf of the EFSA. For GM products likely to be used
as either food or feed, authorisation would be recommended for
either or both uses or none at all. On the basis of the opinion
of the EFSA, the Commission will be responsible for drafting a
proposal granting or refusing authorisation. The proposal will
then be put to Member States for final approval.
The
scope of application for the labelling of GMOs would not include
products derived from animals fed with GM feed (eggs, milk and
meat).
The
proposals went through a long period of gestation and debate,
but finally emerged from their second reading in the European
Parliament in June 2003. The new legislation was given final
approval by the Council of Ministers on 22 July 2003, published
in the Official Journal of the European Union on 22 September
2003 and designated
Regulation
(EC) 1829/2003 of the European Parliament and of the Council of
22 September 2003 on genetically modified food and feed;
http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00010023.pdf
and
Regulation (EC) 1830/2003 of the European Parliament and of the
Council of 22 September 2003 concerning the traceability and
labelling of genetically modified organisms and the traceability
of food and feed products produced from genetically modified
organisms and amending Directive 2001/18/EC .
http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00240028.pdf
These
mean that GM crops have to be kept separate from conventional
crops and put strict limits on the accidental mixing of the two.
The rules allow for no more than 0.9% accidental mixing of GM in
non-GM shipments to the EU. All products containing more than
0.9% GMOs have to be distinctively labelled as genetically
modified. Genetically modified material will also have to be
traced at all stages of production.
Several countries in the EU had
said they would keep the unofficial moratorium in place until
the new legislation regarding labelling and traceability was
introduced. Member States were divided in several votes since
December 2003, which under EU rules sent the decision ultimately
to the EU Commission.
On 12 May
2004 the Commission decided to lift the 6-year-old unofficial
moratorium by approving imports of an insect-resistant Bt11
strain of sweet corn for human consumption from Swiss-based
Syngenta. This GM corn would only be imported and not grown in
the EU, although an application for cultivation is pending. Any
sold – whether canned or fresh - would have to be labelled in
accordance with the new Directives. This development has not,
however, stopped the
US
from going ahead with its WTO case against the EU. Although
favouring a lifting of the moratorium, the US considers such
stringent labelling laws unworkable and in practice as trade
barriers.
David
Byrne, EU Commissioner for Health and Consumer Protection, said
the GM corn was approved after "the most rigorous pre-marketing
assessment in the world”.
"It has
been scientifically assessed as being as safe as any
conventional maize. Food safety is therefore not an issue, it is
a question of consumer choice. Labelling provides consumers with
the information they need to make up their own mind. They are
therefore free to choose what they want to buy."
The question arises, however,
whether, in the present engendered climate of European consumer
fears, importers and retailers in the EU Member States will
consider it too commercially risky to offer consumers that
choice.
In the UK, the Food Standards
Agency has carried out a consultation on the enforcement and
penalties in the UK of these two EU Regulations, and on draft
Guidance Notes
http://www.food.gov.uk/multimedia/pdfs/gmconsultnotes.pdf
although, as FSA points
out, this is draft informal guidance for application of both
Regulations in the UK and cannot modify the Regulations
themselves.
In the UK DEFRA is carrying out a
consultation on proposals
http://www.defra.gov.uk/corporate/consult/gm-transboundary/index.htm
for administering and
enforcing Regulation (EC) No 1946/2003 of the European
Parliament and of the Council on transboundary movements of GMOs
http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_287/l_28720031105en00010010.pdf
coming into force in
November 2004
The laws
also allow EU Member States to take “appropriate measures” to
ensure GM crops planted in the EU do not cross-pollinate with
conventional crops. However, on 26 January 2004, EU Agriculture
Commissioner Franz Fischler warned delegates at a conference on
organic farming that food which is completely free of GMOs is a
thing of the past. When it comes to setting acceptable
thresholds for the levels of GMOs in organic and conventional
products, the Commissioner said that
Europe must take guidance from scientists, rather than
politicians. 'We have been banished from paradise. The idea of
a zero per cent threshold was no doubt possible in the Garden of
Eden, but not in the real world,' said Dr Fischler. Then on
23 February 2004
a report was issued by the (US) Union of Concerned Scientists
entitled "Gone to Seed: Transgenic Contaminants in the
Traditional Seed Supply". It described tests carried out in USA
on supposedly unmodified corn, soy and canola seeds, all
purchased commercially. Of 18 seed varieties tested, 16 seemed
to contain some GM elements.
On
27 February
2004 the 87 member states of the Cartagena Protocol on
Biosafety, which entered into force in September 2003, adopted
documentation requirements and other procedures for promoting
the safety of international trade in GMOs
http://www.biodiv.org/doc/press/2004/pr-2004-02-27-bs-en.pdf
Conclusions
The
exercise of informed choice by consumers requires that they have
accurate and unbiased information. The reverse is currently the
case. The provision of such information will be a key factor in
the acceptance of food applications of gene technology.
IFST
fully supports the notion that academic and industrial
scientists, professional bodies, learned societies, food
retailers, governments and consumer organisations must all play
an active role in communicating both the benefits of, and
concerns about, GM foods to the public. The realisation of the
potential benefits of gene technology will depend both on the
further work of scientists in addressing and solving the
above-mentioned potential problems and on effective
communication between scientists and the rest of society,
including the lay public.
Food
scientists and technologists can support the responsible
introduction of GM techniques provided that issues of product
safety, environmental concerns, information and ethics are
satisfactorily addressed. IFST considers that they are being
addressed, and need even more intensively to continue to be so
addressed. Only in this way may the benefits that this
technology can confer become available, not least to help feed
the world's escalating population in the coming decades.
On-line
References
In
addition to Web addresses given in the text of this Information
Statement, the following are useful references:
Advisory
Committee on Novel Foods and Processes (ACNFP) (UK) Annual
Reports 1989-2001,
http://www.food.gov.uk/science/ouradvisors/novelfood/acnfpannual
Animal &
Plant Health Inspection Service of USDA, Biotechnology
Regulatory Services,
http://www.aphis.usda.gov/brs
Bennett, P
M et al, "An assessment of the risks associated with the use of
antibiotic resistance genes in genetically modified plants”:
report of the Working Party of the British Society for
Antimicrobial Chemotherapy
http://www.agbiotechnet.com/news/Database/jac.oupjournals.org/
Biotechnology at Work Web site of the Department of Trade and
Industry (UK)
http://www..dti.gov.uk/biowise
Department
of Health (UK) "Health Implications of Genetically Modified
Foods"
http://www.doh.gov.uk/gmfood.htm
Department
of Food, Environment and Rural Affairs (UK)
http://www.defra.gov.uk
Center for
Science in the Public Interest: “Genetically Engineered Foods:
Are They Safe?”
https://cspinet.safeserver.com/nah/11_01/index.html
European
Food Safety Authority (EFSA) Scientific advice on the use of
antibiotic resistance marker genes in genetically modified
plants
http://www.efsa.eu.int/press_room/press_release/386_en.html
European
Union DG Consumer Policy and Consumer Health Protection
("Sanco") Web site
http://europa.eu.int/comm/food/index_en.html
Question and Answers on the
regulation of GMOs in the
European Union :
http://europa.eu.int/comm/food/index_en.html
European
Union: Consultation on "Life Sciences and Biotechnology: A
Strategic Vision"
http://europa.eu.int/comm/dgs/health_consumer/library/press/press298_en.pdf
European
Union: Questions and Answers on the European Food Safety
Authority
http://europa.eu.int/comm/dgs/health_consumer/library/press/press135_en.pdf
European
Union: European Food Safety Authority Website
http://www.efsa.eu.int
Foodfuture:
Food and Biotechnology, Food and Drink Federation (UK)
http://www.foodfuture.org.uk
Food and
Agriculture Organisation (FAO). Report of Joint FAO/WHO
Consultation on Biotechnology and Food Safety
http://www.fao.org/es/ESN/food/pdf/biotechnology.pdf
Food and
Agriculture Organisation (FAO). Annual Report, "The State of
Food and Agriculture 2003-04"
ftp://ftp.fao.org/docrep/fao/006/Y5160e/y5160e00.pdf
IFIS:
Review of some
some GM-relevant Websites
Institute
of Food Science & Technology (IFST)
http://www.ifst.org
Nuffield
Council on Bioethics (1999). Report "Genetically modified crops:
the ethical and social issues".
http://www.nuffield.org/fileLibrary/pdf/gmcrop.pdf
Nuffield Council on Bioethics
(2003). Follow-up Discussion Paper “The use of genetically
modified crops in developing countries”
http://www.nuffieldbioethics.org/filelibrary/pdf/gm_crops_paper_final.pdf
The Royal
Society
http://www.royalsoc.ac.uk
Royal
Society Statements:
Feb 1998:
Genetically Modified Plants for Food Use;
March 1999: The Regulation of Biotechnology in the UK;
April 1999: Scientific Advice on GM Foods: A Response to the
inquiry by the House of Commons Science and Technology
Committee;
April 1999: GMOs and the Environment: A Response to the inquiry
by the House of Commons Environmental Audit Committee.
Links at
http://www.royalsoc.ac.uk/policy/rep_fr.htm
UK House of Commons, Select Committee on Science and
Technology
http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/9030801.htm
http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmselect/cmsctech/286/9030801.htm;
and
http://www.publications.parliament.uk/pa/cm199899/cmselect/cmsctech/286/28602.htm
World
Health Organisation (WHO): 20 Questions On Genetically Modified
(GM) Foods
http://www.who.int/fsf/Documents/20_Questions/q&a.pdf
The
Canadian Food Inspection Agency 's Food Safety Enhancement
Program Web page of links at
http://www.cfia-acia.agr.ca/english/ppc/haccp/haccp.html
Further
Printed Information
Advisory
Committee on Novel Foods and Processes (ACNFP). 1989-2001.
Annual Reports. Available from ACNFP Secretariat, Food Standards
Agency, Aviation House, 125 Kingsway, London WC2B 6NH, UK. (See
also On-line References)
Advisory
Committee on Releases into the Environment (ACRE). 1993-present. Annual Reports. Available from DEFRA,
Nobel House,
17 Smith
Square, London SW1P 3JR, UK (See also On-line References)
Astwood, J.D. et al. 1996.
Stability of food allergens to digestion in vitro. Nature
Biotechnology 14, 1269-1273.
Committee on the Ethics of Genetic Modification and Food Use
(The "Polkinghorne Committee"). 1993. Report. Available from
HMSO, P.O. Box 276, London SW8 5DT.
European
Committee for Standardization (CEN): European Standard EN ISO 21572 :2004 “Methods for
detection of Genetically modified organisms and derived products
– Protein based methods”
Food
Advisory Committee (FAC). 1990-present. Annual Reports and
Guidelines for the Labelling of Foods Produced using Genetic
Modification. 1994. Available from FAC Secretariat, Food
Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH,
UK. (See also On-line References)
Food
Labelling (Amendment) Regulations 1999. S.I. 1999/747 (UK)
Foodsense. Genetic Modification and Food. Leaflet available from
DEFRA, London SE99 7TT.
Food and
Drink Federation. 1995, 1997. Food for our Future and Modern
Biotechnology - Towards Greater Understanding. Colour brochures
available from the FDF, 6 Catherine Street, London WC2B 5JJ.
Herian,
A.M. et al. 1990. Identification of soybean allergens by
immunoblotting in sera from soy-allergic adults.
International Archives of Allergy Applications and Immunology
92, 193-198.
Institute of Food Science and Technology (IFST). 1996.
Guide to Food Biotechnology. Available from IFST, 5
Cambridge Court, 210 Shepherd's Bush Road, London W6 7NJ, UK.
Institute of Grocery Distribution. 1996, 1997. Biotechnology
Factfile. Available from IGD, Grange Lane, Letchmore Heath,
Watford, Herts., WD2 8DQ.
James,
C. (2001) Global Status of Transgenic Crops in 2001. ISAAA Brief
No. 24. ISAAA, Ithaca, New York.. 30 pp.
Novel
Foods and Novel Food Ingredients Regulations 1997. S.I.
1997/1335 (UK).
Nordlee, J.A. et al. 1995.
Identification of Brazil-nut allergen in transgenic soybeans.
New
England Journal of Medicine
334,
688-692.
Nuffield
Foundation on Bioethics (1999). Report "Genetically modified
crops: the ethical and social issues" (also available on
http://www.nuffieldbioethics.org/filelibrary/pdf/gmcrop.pdf
).
Regulation (EC) No. 258/97 of the European Parliament and the
Council of 25 January 1997 concerning Novel Foods and Novel Food
Ingredients, Official Journal of the European Communities
No L 43, 14 February 1997.
Thompson, J (2003) Chapter 3 in Report on "Genetically Modified
Foods for Human Health and Nutrition: The Scientific Basis for
Benefit/Risk Assessment"; a Monograph resulting from an ICSU
sponsored workshop in 2002 (in press).
UK National Consensus Conference on Plant
Biotechnology. 1994. Final Report. Available from The
Science
Museum, London SW7 2DD, UK.
The Codex
Alimentarius Commission revised 3 basic texts on food hygiene in
1997; officially published in Volume 1B of the Codex
Alimentarius and have been republished in a compact format: 15 x
21 cm, 58 pages, ISBN 92-5-104021-4 Contents:
May be obtained through the worldwide Sales Agents, see
http://www.fao.org/ or
Publication-sales@fao.org(cost around $7).
The
Institute of Food Science & Technology (IFST) is the independent professional qualifying body for food
scientists and technologists. It is totally independent of
government, of industry, and of any lobbying groups or special
interest groups. Its professional members are elected by virtue
of their academic qualifications and their relevant experience,
and their signed undertaking to comply with the Institute's
ethical Code of Professional Conduct. They are elected solely in
their personal capacities and in no way representing
organisations where they may be employed. They work in a variety
of areas, including universities and other centres of higher
education, research institutions, food and related industries,
consultancy, food law enforcement authorities, and in government
departments and agencies. The nature of the Institute and the
mixture of these backgrounds on the working groups drafting IFST
Information Statements, and on the two Committees responsible
for finalising and approving them, ensure that the contents are
entirely objective.
IFST recognises that research is constantly bringing new
knowledge. However, collectively the profession is the
repository of existing knowledge in its field. It includes
researchers expanding the boundaries of knowledge and experts
seeking to apply it for the public benefit.
Its purposes are:
(1) to serve the public interest by furthering the application
of science and technology to all aspects of the supply of safe,
wholesome, nutritious and attractive food, nationally and
internationally;
(2) to advance the standing of food science and technology, both
as a subject and as a profession;
(3) to assist members in their career and personal development
within the profession;
(4) to uphold professional standards of competence and
integrity. |