Food
8.
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8.
Food
Key issues:
* Is genetically modified food safe to eat?
* Are the current food safety standards satisfactory?
* Can people choose whether or not to eat genetically modified food?
1.
From the submissions received and the statements made at the public
hearings it was clear genetically modified food was one of the issues that
dominated the discussion. This was no surprise. Food is a matter of personal
importance to individual New Zealanders. As food production for domestic
consumption and for export contributes significantly to the economy, it is also of
national importance.
2.
Some submissions questioned the need for genetically modified food. To
some people, the genetic modification of food and food crops is part of
globalisation and the free trade agenda, another avenue for multinational
corporations to exploit developing economies. To others, developments in food,
such as Golden Rice, have the potential to provide part of the solution to third-
world hunger and poverty.
Golden rice
1
Rice is the staple food for two billion people. It is usually milled to remove the outer seed layers
to prevent their high oil content causing spoilage. The remaining grain is low in
ß-
carotene
(Vitamin A). Some 400 million people worldwide suffer from vitamin A deficiency and over 3.7
billion people are iron deficient. These deficiencies lead to poor development and increased
susceptibility to disease. Vitamin A deficiency causes five million deaths annually, and blindness
in a further 500,000 people, while iron deficiency causes anaemia and birth defects.
Golden Rice is a transgenic crop created by Dr Ingo Potrykus and his colleagues to improve
the nutritional quality of rice, by increasing the quantities of ß-carotene, the precursor to
vitamin A and improving its iron content. Several genes have been inserted into the rice
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genome, including a daffodil gene, allowing the endosperm (the part that remains after
milling and polishing) to produce ß-carotene. Additionally a phytase gene (which produces
an enzyme to release chemically bound iron), a gene to increase organic iron and a gene to
aid iron absorption in the digestive tract have been added. The presence of ß-carotene in the
endosperm of the transgenic rice gives it a golden colour. The Golden Rice project is trying
to achieve the strategy of the FAO and WHO to "ensure that sustainable food-based
strategies are given first priority particularly for populations deficient in vitamin A and iron,
favouring locally available foods and taking into account local food habits". The research
was funded by the Rockefeller Foundation, the Swiss government and the EU.
The Golden Rice project hopes to provide a cheap form of vitamin supplementation to help
prevent these deficiencies. It is not the product of profit-seeking companies. When viable,
the rice was to be freely distributed with no patents blocking access to it. Dr Potrykus stated
that he was somewhat surprised when it was found that in the creation of his Golden Rice
there were 70 intellectual property rights belonging to 32 different companies and
universities for which he needed free licences to be able to establish a "freedom to operate"
situation. Currently, intellectual property issues are being resolved.
Some believe that Golden Rice is being over-hyped, because it allays public fears about
genetic modification, and that it is not the best solution to the nutritional problems in
developing countries. They point out that, despite all the time and money spent on Golden
Rice, it is not yet available to those it was designed to help, and in fact is several years away
from commercial production. They have also pointed out new agreements with AstraZeneca
and Greenovation mean that, though the companies will donate seeds to developing
countries, only farmers earning less than $10,000 annually from the sale of the rice will be
exempt from paying royalties.
It is also argued that problems with malnutrition have little to do with the nutritional value
of the food consumed. Rather the problems are:
1.
Food distribution. Malnourished people often come from countries with food surpluses.
Golden Rice is a high yield crop and may be grown for export rather than for local
supply. If this happens, people who are too poor to buy food will not be aided by
Golden Rice.
2.
Food preferences. Because of cultural preferences people may choose not to eat Golden
Rice, despite its nutritional benefits.
3.
Food variety. Vitamin A deficiency rarely occurs in isolation, but rather with other
vitamin and mineral deficiencies. Since many species of plant contain ß-carotene, it
would be better to diversify crops and encourage people to eat a wider range of foods
rather than rely on Golden Rice as a single major source of the vitamin.
4.
Effects on agriculture. There are fears about the possible associated effects of the
technology itself on human health and on farming practices in developing countries.
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3.
The Commission's Warrant, however, confines our considerations to issues
relating to genetically modified food in New Zealand. Although diverging views
about the value of genetic modification to developing and developed countries
are important in the overall debate about the use of the technology, issues such as
Golden Rice are not material to our inquiry. We have included an information
panel about it only because the subject was mentioned so often.
4.
The need for genetically modified food was also questioned on the grounds
that New Zealand is self-sufficient in food.
2
The importance of imported food to
the New Zealand population, however, was identified in the submission from the
New Zealand Grocery Marketers Association [IP54]. The submission pointed
out that New Zealand now has a higher proportion of imported processed food
than any other country in the western world.
5.
The Association suggested that there were two reasons for this high rate of
importation. First, the New Zealand climate limited the foods that could be
grown here and, second:
... a very high dependence on pre-processed food imports is associated with that of
economies of scale. With a domestic population of 3.8 million people New Zealand cannot
sustain high volume sophisticated (manufacturing) plants just to supply the domestic
base.
3
6.
The submission also referred to the importance of international companies
in the food production sector in New Zealand. As the Commission listened to
submissions from organisations such as the New Zealand Dairy Board [IP67], we
could not but become aware of the importance of international trade to the New
Zealand companies, growers and food producers who are involved in the export
market. Again, the Grocery Marketers Association explained:
New Zealand's economy is dependent on the food industry. It contributes 42% of the
country's export earnings (the exports for the year ended June 2000 were $24.746
billion of which food contributed $10.336 billion). In addition the processed food
industry contributes $11 billion to the domestic economy.
4
7.
For reasons we will set out, the Commission does not accept that it is a
viable option to ban the production, importation or sale of genetically modified
food in New Zealand. It considers, however, to ensure the health and safety of the
public, the food industry must be subject to rigorous standards enforced and
monitored by competent and careful regulatory bodies.
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The current status of genetic modification
in food and food processing in New Zealand
8.
Genetically modified food may have been on the New Zealand market for
as long as a decade. The Grocery Marketers Association stated that the first food
products modified by gene technology were a yeast used in baking, which was
approved for use in the United Kingdom in 1990, and chymosin, the enzyme used
in cheese making, which was approved for use in the United States, also in 1990.
The Flavr-Savr tomato, which was the first whole food produced using gene
technology, received approval in the United States in 1994. Transgenic soybeans,
corn, cotton and potato, from which many ingredients are now derived, were
approved overseas during the 1990s.
5
These foods could have come into New
Zealand as ingredients in imported food.
9.
It was difficult to establish the nature and range of the genetically modified
food available on the New Zealand market. The Australia New Zealand Food
Authority (ANZFA) is required to conduct a scientific assessment process prior
to genetically modified foods being released. At the time the Commission's
inquiry began, there were a number of genetically modified foods on the New
Zealand market that had not completed this process. This was because, during
the time that Standard A18: Food Produced Using Gene Technology, which regulates
the sale of genetically modified food, was being developed in 1996 and 1997, a
number of genetically modified foods entered the Australian and New Zealand
markets legally without being assessed by ANZFA. These were largely
components of imported processed foods. Subject to certain conditions, these
foods were allowed to remain on the market while they went through the ANZFA
system for assessing compliance with Standard A18. At the hearing before the
Commission, ANZFA was questioned further on this matter. (See paragraphs 129
to 202.)
Processed food
10. The submission from the Grocery Marketers Association stated there are
"no whole genetically modified foods on the market" in New Zealand. At the
time of the Commission's hearings, therefore, all genetically modified foods were
used as ingredients in imported foods. The Association provided a list, reproduced
overleaf, of examples of the products that might be present in foods currently
available in New Zealand. The Association pointed out, however, that it is not
possible to state the extent to which the products listed are used in New Zealand.
6
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Ingredients derived from genetically modified crops
Genetically
Ingredient, additives and
Used in following foods
modified
processing aids
organisms
Soybean
soybean flour
soy drinks, soy sauce, tofu
soybean protein
processed meats/sausages/salamis
hydrolysed vegetable protein
bread
textured vegetable protein
dairy ­ drinks, yoghurts, desserts,
ice cream
soybean oil
baked goods ­ cakes, pies,
pastries, biscuits
lecithin
soups and sauces
additive and flavour carriers/
cooking oils, salad dressings
diluents
tocopherols ­ vitamin E
margarines and spreads,
peanut butter
confectionery, savoury snacks,
infant food
Corn/Maize
flour
bread
corn starch
dairy products ­ drinks, yoghurts,
desserts
corn oil
baked goods ­ cakes, pies, pastries,
biscuits
corn protein and isolates
soft drinks and cordials
corn syrups
soups
modified starches
sauces, pickles and
chutneys
dextroses
cooking oils, salad dressings
maltodextrins
margarines and spreads
glucose syrups
confectionery, fruit flavoured spreads
humectants, food acids
savoury snacks
additive and flavour carriers/
herb and spices (through carriers
diluents
and diluents)
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Ingredients derived from genetically modified crops
continued
Genetically
Ingredient, additives and
Used in following foods
modified
processing aids
organisms
Canola
canola oil
baked goods ­ cakes, pies, pastries
lecithin
salad dressings
cooking oils
margarines and spreads
confectionery
Cotton
cotton seed oil
baked goods
cooking oils
salad dressings
margarines
Sugar beet
sucrose
dairy products ­ drinks, yoghurts,
desserts
mono sodium glutamate (MSG)
bread
baked goods ­ cakes, pies, pastries,
biscuits
soups
sauces
fruit drinks, soft drinks and cordials
jams and preserves
confectionery
savoury snacks
Potato
potato
soups
potato starch
sauces, pickles and chutneys
modified starch
confectionery
savoury snacks
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Microorganisms
11. The Grocery Marketers Association told the Commission that, in addition
to the genetic modification of whole plant foods, microorganisms could be
designed to improve the efficiency of fermentation and other primarily enzymatic
processes, and be used in the production of ingredients. The Association listed
these uses as being:
*
microbes to produce amino acids for the synthesis of aspartame
*
plant cells grown in fermenters to produce flavours such as vanilla
*
chymosin, a replacement for calf rennet, overseas supplies of which are
inadequate to meet needs
*
alpha-amylase, which is used in the production of high fructose corn syrups
*
lactase, which is added to milk to reduce the lactose content for persons
with lactose intolerance
*
bakers' yeast modified to provide faster carbon dioxide production, which
improves dough characteristics
*
brewers' yeast with an ability to degrade starch and for use in making
reduced calorie beer.
Grains and cereals
12. The first generation of genetically modified crops were the important grain
and cereal crops, tomatoes and some niche products, such as papaya. Traditionally,
most of New Zealand's supplies of these products have been imported and no
genetically modified crops have yet been approved for commercial cultivation in
New Zealand.
Fresh produce
13. The submission from the New Zealand Vegetable and Potato Growers'
Federation/New Zealand Fruitgrowers' Federation/New Zealand Berryfruit
Growers' Federation (Vegfed, Fruitgrowers, Berryfed) [IP75] pointed out that
very few genetically modified fruit cultivars or species are being traded on world
markets, possibly because the development of genetically modified fruit has been
of lower priority than mainstream agronomic crops. No genetically modified
fresh fruit or vegetables are currently imported into New Zealand. Any fresh
produce would require ANZFA approval before it was released on to the New
Zealand market, and any produce that contained viable seed or provided
propagation material would also require approval from the Environmental Risk
Management Authority (ERMA).
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Meat
14. We heard no evidence of products from genetically modified animals,
either raised in New Zealand or imported, being available on the New Zealand
market. Both would require ANZFA approval. Dr Phil L'Huillier, a scientist with
AgResearch [IP13] at Ruakura, informed us of research currently underway into
myostatin knockout sheep to increase musculature and, as a result, to improve
meat quality. The submissions from both Meat New Zealand [IP31] and the New
Zealand Game Industry Board [IP33], however, confirmed that neither
organisation would sanction the entry of transgenic products into the food chain
without strong public support. The same view was expressed by a number of
primary industry sector representatives.
Dairy products
15. We understood from the evidence that, at present, there is only limited use
of genetic modification in the New Zealand dairy industry. The New Zealand
Dairy Board said that, as a result of public attitudes towards the use of gene
technology, policy decisions had been taken in at least two instances not to make
use of the available technology. It confirmed that the industry does not take milk
from cows that have been treated with injections of bovine somatotropin (bST),
and does not use genetically modified bacterial cultures in cheese making. The
Dairy Board's submission also confirmed that no pasture plants or dairy cattle
used in the production of milk were genetically modified. It said that "apart from
some well-known and approved additives and processing aids" no foods derived
from genetically modified organisms are used in any of the range of food
products manufactured from milk.
7
There was limited use of the enzyme
chymosin, produced by genetic modification, in cheese for overseas markets.
Animal feed
16. At the hearing before us, the New Zealand Feed Manufacturers Association/
Poultry Industry Association of New Zealand/Egg Producers Federation of New
Zealand [IP35] confirmed that poultry in New Zealand was fed a combination of
modified and unmodified soy meal.
8
Meat New Zealand advised that, while
genetically modified soy products are being used in animal feeds, they do not
appear to be being used in the red meat industry in New Zealand. We discuss the
safety of genetically modified stock feed in paragraphs 121 to 126.
Future developments
17. We heard evidence that, while the first wave of genetically modified food
was seen as having benefit primarily to commercial interests, the second wave
would have clear consumer benefits in addition to those for food growers and
manufacturers.
18. Many of the references to the future developments of genetically modified
food were general in nature. There were claims that the use of gene technology in
relation to food will have the following benefits for the food industry:
*
improved productivity with increased efficiency, sustainability and cost-
effectiveness
*
improvements to food safety; for example, use of the technology to detect
food-borne pathogens, toxins and chemical contaminants
*
improvements to storage properties, such as by extending the shelf-life of
foods
*
the use of gene technology for checking alterations in product quality and
checking for temperature abuse.
19. Benefits for the consumer are expected to be:
*
products with improved tastes, textures and keeping qualities
*
foods that are less allergenic and contain lower levels of toxins
*
new foods with elevated levels of nutrients and bioactive agents
*
reduced chemical use during the growing process, with a consequent
minimisation of chemical residue
*
reduction in pathogens causing harm to human health.
We heard a number of claims that gene technology will result in the development
of foods with properties that will have a range of direct benefits for human health.
This area of `functional' or `nutraceutical' foods is considered in more detail in
chapter 9 (Medicine).
20. The New Zealand Grocery Marketers Association provided a list, as shown
opposite, of genetically modified foods currently being developed.
9
Public perceptions
21. Throughout the Commission's processes, many people expressed concerns
about the safety of consuming genetically modified food. Over 68% of the written
submissions we received from the public expressed the view that the use of
genetic modification in food production was unacceptable. Many of the Interested
Persons who appeared before us at the formal hearings referred to the widely held
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Genetically
Modification
Potential benefit
modified
food
Potatoes
Increased levels and better
More effective processing, less
distribution of starch levels
absorption of fat when frying potatoes
Potatoes
Developed to contain a high
Lower fat absorption. Improved
volume of proteins
texture.
Replacement for non-animal proteins
and synthetic protein derivatives
Rice
Enhanced with ß-carotene, a
A cure for blindness in third world
precursor for Vitamin A.
countries.
Improved nutrition
Improved nutritional value
Corn and soy Lower levels of saturated fats.
Improved nutritional values.
Fats higher in oleic acid
Enhanced use
Rice
[Reduce allergenic proteins]
Of advantage to people with rice
allergies
Tomatoes
Higher lycopene levels
An antioxidant
Garlic cloves Higher allicin levels
Cholesterol lowering agent
Strawberries Higher ellagic acid content
Health benefits
Vegetables,
Enhanced flavonoids, carotenoids Improved nutrition and enhanced
fruits, and
and omega fatty acids
health benefits.
seafood
WHO has reported that more than
30% of non-communicable diseases
can be prevented by diet.
The evidence of the health benefits of
flavonoids, carotenoids and omega-3
fatty acids are increasing
Cereal grains Changes to the structure of
Improves the digestibility of cereal
the grain
and bakery products with improved
control of glycaemia
Milk
Enhanced casein and calcium
Improved nutritional and health
content
benefits
Genetically modified foods under development
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public uncertainty about the consumption of genetically modified food. Some of
the Interested Persons and many of the people who spoke at the public meetings
urged caution, largely because of concerns about safety. Some of the Interested
Persons, such as GE Free New Zealand (RAGE) in Food and Environment
[IP63] and Nga Wahine Tiaki o te Ao [IP64], strongly opposed genetically
modified food and sought a total ban on allowing genetically modified food to be
either sold or grown in New Zealand. The Safe Food Campaign [IP86]
recommended that a "no regrets" approach should be adopted and suggested that:
... in order to prevent harm from occurring rather than manage the risks once harm has
occurred, New Zealand should not utilise GM as a strategic option. As an alternative
strategic option the Safe Food Campaign supports New Zealand becoming a GM-free zone
and an organic nation.
10
22. The Commission's own survey, conducted by BRC Marketing and Social
Research, confirmed that the wider New Zealand public were aware of the use of
genetic modification in relation to food and many also had concerns about the
technology.
23. Almost all the people who responded to the survey were aware that genetic
modification was being used in processed food. Significantly, well over half of the
respondents thought that genetic modification was already being used, to a
greater or lesser extent, in commercial crops in New Zealand.
11
Although there
was no direct questioning on the subject, it is possible that some of those people
believed that genetically modified food crops were already being grown for sale,
rather than just as small research plots within some degree of containment.
24. A significant number of people questioned (69%) saw genetically modified
processed food as having more disadvantages than advantages. We were interested
to note that over half the respondents who saw genetic modification as being
important to New Zealand's future also thought that genetically modified
processed food had more disadvantages than advantages.
12
Clearly, even some of
those who were generally positive about the use of the technology had reservations
about its use in relation to food. It was not surprising, therefore, that processed
food was the area of genetic modification with the highest disapproval rating both
by those who saw genetic modification as being important to New Zealand's
future and those who saw it as being unimportant.
13
Clearly genetically modified
food is a source of concern, at times great anxiety, for a significant proportion of
the New Zealand population.
25. Submissions received from both the public and the Interested Persons
focused mainly on the safety of genetically modified food and on the possible
adverse impacts from consumption. In particular, we heard concerns about the
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development of allergens and toxic substances in foodstuffs that had hitherto
been considered safe to consume, about increasing antibiotic resistance among
humans and animals as a result of the use of antibiotic marker genes, and about
possible changes to the nutritional and other properties of modified food.
26. People were concerned about not only their personal health but also the
possible impact of genetically modified food on their family's health and that of
future generations. One public submission we received said:
I wish to claim under the Human Rights Act the right to protect the future gene pool and
health of our food and children by banning genetically modified foods from growth or
food production in New Zealand. I will be horrendously angry with any government that
Bovine spongiform encephalopathy (BSE)
14
Bovine spongiform encephalopathy (BSE), widely known as "mad cow disease," is a chronic,
degenerative disease affecting the central nervous system of cattle. Worldwide there have
been more than 178,000 cases since the disease was first diagnosed in Great Britain in 1986.
Although the disease has also been confirmed in native-born cattle in other parts of Europe,
over 95% of all BSE cases occurred in the United Kingdom. Epidemiologic data suggested
that BSE in Great Britain is a common-source epidemic involving animal feed containing
contaminated meat and bone meal as a protein source.
In 1988, the UK Government introduced legislation that required all cattle suspected of
suffering from BSE to be destroyed and sent for diagnosis. In 1989 controls were imposed
that banned from the human food chain tissues of cattle, sheep and goats known to, or that
might potentially, harbour detectable BSE infectivity.
In 1996, BSE was linked with a new variant form of Creutzfeldt-Jakob Disease (CJD).
Classical CJD, which was first diagnosed in the 1920s, is a slow degenerative human disease
of the central nervous system which occurs sporadically worldwide, including in Australia
and New Zealand, at a rate of one case per one million people per year. On 20 March 1996,
the UK's Spongiform Encephalopathy Advisory Committee (SEAC) announced the
identification of 10 cases of a new variant form of CJD (vCJD). All the patients developed
onset of illness in 1994 or 1995 and the features of CJD in these 10 cases differed from the
sporadic form of CJD.
The SEAC concluded that, although there was no direct scientific evidence of a link
between BSE and vCJD, based on current data and in the absence of any credible alternative,
the most likely explanation at that time was that the cases were linked to exposure to BSE
before the introduction of control measures, in particular the specified bovine offal ban that
had been imposed in 1989. Research reported later in 1996 and in 1997 found further
evidence to support a causal association between vCJD and BSE.
The official report into BSE strongly criticised government ministers and officials for
consistently playing down the risk to humans and for failing to coordinate properly a
government response.
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has neither the foresight or the courage to stand up to the pressure of multinational
conglomerates in this matter.
15
27. The submission from the social scientist members of the Royal Society of
New Zealand [IP77b] cited evidence to show that international consumer
reaction to genetically modified foods is becoming increasingly negative. Dr
Hugh Campbell, giving evidence in support of Organic Products Exporters
Group [IP53], suggested that, in New Zealand, the public's concern about
genetically modified food was a "food scare".
16
Certainly, a number of the people
who made submissions to us drew parallels between genetically modified food and
BSE in order to illustrate both the hidden dangers of food and an apparent lack of
scientific or regulatory rigour. A major outbreak of foot-and-mouth disease in
Britain and Europe at the time of the Commission's inquiry served to heighten
public awareness of the potential for rapid spread of disease among animals.
28. Although some people clearly have a high level of anxiety about genetically
modified food, the Commission is not persuaded that the general level of concern
in New Zealand can be described as a "food scare". We agree, however, that there
is widespread public unease about the use of genetic modification in relation to
food, which should be taken into account by central government and the relevant
regulatory agencies when making any decisions relating to genetically modified
food in New Zealand.
29. Dr Lynn Frewer presented useful evidence on public attitudes to genetic
modification. Dr Frewer, who was called as a witness by Crop and Food Research
[IP4], is a psychologist and Head of the Consumer Science Section in the UK
Institute for Food Research. In her discussion of international consumer attitudes
towards genetically modified food, Dr Frewer suggested that:
... consumer negativity towards genetically modified foods appears to have arisen
because of the order of entry of products into the market place. The public perceived
that the first genetically modified foods available were of benefit to industry rather than
the consumer, which led to increased rejection of products. Research has shown that
novel foods with direct and tangible consumer benefits are more acceptable than those
from which only industry will benefit or profit. Perceptions of need and advantage
(particularly associated with human health, environmental advantages, or animal
welfare) will offset perceptions of risk, but only if the claims made about these benefits
are realistic.
17
30. The Commission was told that some producers and sellers of foods
overseas were responding to consumer preferences by declining to use or sell
genetically modified products. Primary sector industries in New Zealand
involved in food production indicated they would be cautious of using genetically
modified products because of negative public perceptions.
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31. In her written brief and at the hearing before us, Dr Frewer commented on
the complexity of the causes for public concern and the variability of consumer
attitudes towards genetically modified food. Dr Campbell's comments on Dr
Frewer's evidence and his own views on consumer attitudes were noted by the
Commission. There were significant areas of agreement in their evidence,
particularly with regard to the complex causes and variability of public attitudes,
and the potential difficulty of changing established attitudes. We agree there is a
need for the public's concerns to be taken into account in all discussions about the
use of the technology, particularly in relation to food, with which, as Dr Campbell
pointed out, humans have an "ongoing ambiguous and paradoxical relationship".
18
32. The Grocery Marketers Association suggested that, while consumers
perceive the genetically modified foods and food ingredients currently on the
market as having benefit only to corporate and agricultural interests:
In the future, genetically modified foods will have many direct benefits for the consumer.
For example, the ability to produce foods with higher nutrient and health qualities such
as lower saturated fats, higher vitamin levels and higher antioxidant levels, will have
enormous benefit for consumers, particularly as the link between diet and health is
becoming increasingly evident.
19
33. Dr Frewer, however, suggested that, while this second wave of genetically
modified foods might be more acceptable, attitudes were unlikely to be changed
easily where consumers had already formed strong opinions against genetic
modification. She said:
Recent information campaigns in Europe, which have emphasised the positive and
beneficial aspects of genetic modification, have not convinced consumers that genetic
modification of foods is desirable, or even acceptable in principle. Other information
provided by pressure groups which oppose the technology, appears to have been more
influential.
20
34. On the evidence, there is currently a high level of mistrust of genetically
modified food. Among some people, possibly the group Dr Frewer described as
"being very vocal in providing input into the public debate",
21
mistrust may
amount to acute anxiety about the safety of genetically modified food, while for
others there may be simply a level of uncertainty based on a variety of reasons.
The Commission's survey, and other surveys of public opinion, suggest that, even
though there may be some personal benefit to consumers from the second wave of
genetically modified food, there is no certainty it will be acceptable to a
significant proportion of the population in the near future.
35. We noted, however, Dr Frewer's opinion that consumer unease about
genetically modified food may relate to the lack of public inclusion in the debate
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on genetic modification, rather than, or as well as, a lack of confidence in food
testing measures.
22
We concur in her view that there is a need for communication
about genetic modification to take into account public concerns about the use of
the technology, and for the public to be included in the ongoing debate about
genetic modification, particularly given the increasing use of genetic modification
in relation to food crops and products overseas. We consider the debate should
extend beyond discussion of the risks and should encompass a broad range of
issues relevant to the use of gene technology in relation to food and human health.
We suggest that the agencies responsible for regulating the sale of genetically
modified food in New Zealand have an important role in this debate. We would
encourage regulatory agencies such as ANZFA, the proposed New Zealand Food
Administration Authority and the Ministry of Health to take every opportunity
for communicating with and for listening to the public. In particular, we
commend the establishment of interactive websites that provide accurate, current
information on issues relating to the genetic modification of food and food
products, and that allow for the public to express their views.
Current New Zealand regulatory
responsibilities for food
36. Submissions from ANZFA, and the Ministries of Health, Agriculture and
Forestry, Consumer Affairs and Foreign Affairs and Trade provided information
on the regulatory framework and international obligations relevant to genetically
modified food.
Food standards
37. Food standards, which regulate the quality and composition of the food
available on the market, are designed primarily to protect public health and
safety. In December 1995, the New Zealand Government entered into the Food
Standards Treaty, formally known as the Agreement between the Government of
New Zealand and the Government of Australia Establishing a System for the
Development of a Joint Food Standards. The Food Standards Treaty encompasses
primarily food composition and labelling requirements. It does not cover the
setting of maximum residue limits, food hygiene (including food safety plans)
and export requirements relating to third-country trade. The Food Standards
Treaty, together with the Trans-Tasman Mutual Recognition Arrangement
(TTMRA), which came into effect in 1998, are part of the economic agreements
and arrangements between Australia and New Zealand as a result of the Australia
New Zealand Closer Economic Relations Trade Agreement, known as CER,
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signed in 1983. TTMRA gives effect to mutual recognition principles relating to
the sale of goods and the registration of occupations.
38. The practical implications of TTMRA are that food that can lawfully be
sold in New Zealand may also be lawfully sold in Australia and vice versa. In New
Zealand, these rights are subject to the Fair Trading Act 1986.
39. One of the key outcomes of the Food Standards Treaty was the
implementation of a single set of standards for the composition and labelling of
food that applies in both New Zealand and Australia. These standards comprise
the Australia New Zealand Food Standards Code ("the joint Food Code")
gazetted in New Zealand on 20 December 2000. This will become the sole food
code for both countries in December 2001. Although during the transitional
period, New Zealand food businesses have the option of complying with one of
the current New Zealand Food Regulations, the Australian Food Standards
Code, or the joint Food Code, all food businesses must comply with any
"mandatory standards" in the New Zealand Food Standard 1996. Standard A18,
which regulates the sale of genetically modified food in New Zealand, is a
mandatory standard.
Australia New Zealand Food Authority: structure
and role
40. The Australia New Zealand Food Authority (ANZFA), which develops
food standards for inclusion in the joint Food Code, is a body set up under
Australian law by the Australia New Zealand Food Authority Act 1991. Following
the signing of the Food Standards Treaty in 1995, the existing ANZFA Board was
expanded to include New Zealand representation. New Zealand has two members
and a further representative was appointed as a special member for a limited term at
the request of the New Zealand Minister of Health, specifically to assist in the
process of transition to the new joint Australia New Zealand Food Standards Code.
41. In response to criticism of the nature of the Board membership, its expertise
and understanding of community issues expressed during the course of the
formal hearings, Ian Lindenmayer, Managing Director of ANZFA, provided
further details. He said:
Six of the ten members are themselves scientists. Two of them have high-level medical
qualifications. In fact, both of those two also have a distinguished record in relation to
human nutrition and its medical implications. Two others, one from New Zealand and one
from Australia, [are] distinguished in the areas of nutrition and dietetics, and two others,
again one from New Zealand and one from Australia, have expertise in the areas of food,
science and technology.
23
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42. The remaining members, he said, were he and three others, including a
New Zealand representative, with experience at senior level in government. At
the hearing, Mr Lindenmayer advised that the most recent appointment to the
Board was:
... herself a Maori and who has worked very closely with that community over more than
25 years. ...
24
43. Later, at the Gisborne hui, we heard from the appointee, Hiki Pihema
(Ngati Porou), who is the nutritionist at Cook Hospital, about her hope of
facilitating communication between ANZFA and the Maori community.
44. The Australian State and Territory governments, the Commonwealth
government and the New Zealand government fund ANZFA. Through the
Minister of Health, New Zealand enters into an annual Partnership Agreement
with the Chairperson of ANZFA. Under these arrangements, New Zealand
makes financial contributions to ANZFA's work in developing food standards for
both countries, but not to ANZFA functions that lie outside the Treaty. The
financial contribution is based on population share.
45. ANZFA conducts risk assessments, initiates and coordinates expert panels
and reference groups and undertakes consultation to develop recommended food
standards. In reviewing food standards and developing its recommendations,
ANZFA seeks advice from the broad community (including industry, consumers
and others) and government agencies from both countries. It also receives advice
from government agencies in Australia and New Zealand through the Australia
New Zealand Food Authority Advisory Committee (ANZFAAC) and a working
group of Senior Food Officers. Currently, nominees of the Ministry of Health
and the Ministry of Agriculture and Forestry represent New Zealand on both
these committees.
46. ANZFA does not have authority to make final decisions to adopt new food
standards. These are made through consensus or a majority vote of the Australia
New Zealand Food Standards Council (ANZFSC). The council comprises ten
Ministers of Health; the New Zealand Minister of Health, the Federal Minister
of Health and the Ministers in the eight Australian States and Territories.
Proposed changes to the process for establishing
food standards
47. ANZFA's written submission advised that the Authority will be replaced by
a new organisation, Food Standards Australia New Zealand (FSANZ). This
alteration will require amendments to the Australia New Zealand Food Authority
Act and, as a consequence, to the Food Standards Treaty. At the time of writing
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this Report, the amendment had been considered by the Australian Senate but had
not completed its legislative passage.
48. The proposed changes will affect the membership and function of the new
Authority's governing body and the role and responsibilities of the Ministerial
Council. It is also possible that the powers of the Australian Federal government
in relation to food standards may be increased.
49. Some Interested Persons had reservations about these proposed changes. In
particular, there were concerns that New Zealand representation on the governing
Board may be proportionately less than it currently enjoys, and that any additional
power given to the Federal government would be to the detriment of New
Zealand's sovereignty. The proposal that Ministers from portfolios other than
Health should sit on the Ministerial Council also gave rise to concern.
50. During the hearing attended by representatives of ANZFA, Sue Kedgley
MP, representing the Green Party of Aoteoroa/New Zealand [IP83] and the Safe
Food Campaign, sought confirmation that changes to ANZFA and the
composition of the ANZFSC were being considered under Australian legislation
and without any discussion in the New Zealand Parliament. Mr Lindenmayer
responded:
The legislation which is currently before the Parliament in Australia is legislation which
is intended to give effect to changes which have been developed by a committee, not
including my organisation, but a committee representing all ten of the jurisdictions.
Secondly, the advice of that committee has gone to government level, to ministerial level,
and I understand there have been discussions encompassing Ministers of New Zealand and
Ministers from the Australian side as well.
An intergovernmental agreement was signed in Australia between the Commonwealth
Prime Minister and the Premiers and Chief Ministers of the States and Territories,
indicating agreement to proceed with the sorts of changes to which you are referring.
My understanding is that, prior to that occurring, there were discussions also with the
Government of New Zealand, and there was acceptance that a move ­ that such a move
would be acceptable.
... It was certainly envisaged that the next stages would be a combination of the
development and passage of legislation through the Commonwealth Parliament, and
discussions between Australian and New Zealand Governments to modify the existing
Treaty, and that there would be some Parliamentary process, and I'm not sure of the
detail, on the New Zealand side too ­ as part of that latter process.
25
51. Ms Kedgley then pointed out that treaties are not discussed in the New
Zealand Parliament. Discussion of proposed treaties by Parliament as a whole is
a constitutional issue outside the scope of our Warrant. Negotiations between the
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New Zealand and Australian Governments over the proposed legislative changes,
and the consequential changes to the Food Standards Treaty, are ongoing. We
anticipate, therefore, that there will be debate within New Zealand about the
issues raised by the proposed amendments.
52. Until the amending legislation has passed through the Australian legislative
process, and the negotiations between the two Governments in relation to the
Food Standards Treaty have been finalised, the full impact of the changes cannot
be known. The Commission makes recommendations relevant to this matter
later in this chapter.
Standard A18 Food Produced Using Gene Technology
53. ANZFA Standard A18: Food Produced Using Gene Technology, Division 1, is
the standard that regulates genetically modified foods. Standard A18 is
incorporated into New Zealand law as a mandatory standard in the New Zealand
Food Standard 1996. Standard A18 regulates the sale and labelling of genetically
modified foods. The text of the Standard is available on the ANZFA website at
www.anzfa.govt.nz.
54. In standard A18, a food produced using gene technology is defined as "a
food which has been derived or developed from an organism which has been
modified by gene technology". A food derived from an animal or other organism
that has been fed food produced using gene technology is specifically excluded
from the definition.
55. Clause 2 of Division 1 of the Standard is a general prohibition on the sale of
genetically modified food. Foods that are exempt from the prohibition are listed
in the table under clause 2, together with any special conditions the Authority has
imposed on them. To be included in the table, a food must have been assessed as
being safe for human consumption in accordance with the Authority's approved
safety assessment criteria. Having satisfied the assessment, the food requires the
consent of ANZFSC before it is listed in the table.
56. Clause 2A in the Standard is a transitional exemption to the general
prohibition on sale. It allows certain genetically modified foods to remain on the
market pending ANZFA assessment. This exemption addresses the fact that
genetically modified foods were imported into New Zealand and Australia
before the Standard came into force in May 1999. Clause 2A(2) permits
genetically modified foods to stay on the market where:
*
an application was made to ANZFA before 30 April 1999 for the food to be
permitted under Standard A18
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*
there is evidence that the food is lawfully permitted for sale in one or more
countries other than New Zealand and Australia, by a national food
regulatory agency
*
ANZFSC has not become aware of evidence that the food poses a significant
risk to public health and safety.
ANZFA process
57. In its written submission, ANZFA stated that, in developing food regulatory
measures such as food standards, its objectives (in order of priority) are:
*
protecting public health and safety
*
providing adequate information relating to food to enable consumers to
make informed choices
*
preventing misleading or deceptive conduct.
58. In making recommendations on food standards, ANZFA must also give
regard to:
*
the need for standards to be based on risk analysis using the best available
scientific evidence
*
the promotion of consistency between domestic and international food
standards
*
the desirability of an efficient and internationally competitive food industry
*
the promotion of fair trading in food.
59. ANZFA outlined the process for developing new food standards or varying
existing standards, initiated either on receipt of an application from an external
body or through ANZFA's own preparation of a proposal. If, after it has made a
preliminary assessment, ANZFA decides to accept an application, submissions
are invited from the public. A full assessment report is made, based on a scientific
risk assessment, taking account of all evidence received in submissions from
interested parties and the public. At the hearing before the Commission, ANZFA
representatives provided further details on the scientific risk assessment that is
carried out as part of the full assessment, and tabled the extensive documentation
related to one such assessment.
26
60. On the basis of this full assessment, ANZFA would either reject the
application or prepare a draft new standard or a variation to an existing standard.
The draft new or varied standard and the full assessment report are circulated to
all individuals and groups that made submissions on the matter, and public
advertisements seek commentary on the appropriateness of the drafting. Finally,
ANZFA makes a recommendation to the ANZFSC based on its consideration of
information and comment received in the third stage.
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61. Before an ANZFSC decision is incorporated into New Zealand law, the
New Zealand Minister of Health must issue an amendment to the New Zealand
Food Standard 1996 that recognises the variation to the Australian Food
Standards Code. The Minister's amendment is then gazetted, and the standard
becomes law in New Zealand after 28 days.
62. Under the Treaty, New Zealand may opt out of a food standard if it
considers the standard to be inappropriate on the grounds of "exceptional health,
safety, third-country trade, environmental or cultural factors". Susie Lees, cross-
examining on behalf of the Environment and Conservation Organisations of
New Zealand (ECO) [IP102] and Nelson GE Free Awareness Group [IP100] at
the special hearing attended by ANZFA, questioned whether, in reality, New
Zealand could choose to opt out of Standard A18.
27
In a letter responding to
questions posed at the hearing, ANZFA confirmed New Zealand could opt out of
Standard A18, even after it had been adopted, by initiating a process leading to a
decision by the ANZFSC that the standard should not apply in New Zealand.
28
However, because of TTMRA, unless exceptional health, safety and
environmental concerns exist, a New Zealand variation will not prevent Australian
food permitted to be sold under Standard A18 being sold on the New Zealand
market. Many submitters considered ANZFA to be predominantly Australian,
and saw the determination of food standards by this organisation as an abrogation
of New Zealand's sovereign right to determine its own affairs for the benefit of its
citizens.
63. Dr Peter Wills, a witness for Physicians and Scientists for Responsible
Genetics [IP107], Greenpeace New Zealand [IP82], Green Party, Friends of the
Earth (New Zealand) [IP78], Sustainable Futures Trust [IP51] and Pacific
Institute of Resource Management [IP84], expressed the mistrust shared by a
number of submitters when he wrote:
Successive New Zealand governments have become parties to a number of agreements
affecting citizens who have had no say in the matter. In respect of the safety of our food
supply, we are now subject to decisions that are made by an international body (ANZFA)
which is dominated by industrial interests. All considerations in relation to these
international obligations are dominated by scientific and technical matters and the
unique cultural and ethical perspective of New Zealanders is given absolutely no weight.
29
64. Understandably, others may share the concern that Australian commercial
interests may dominate ANZFA and undermine the Authority's ability to carry
out its functions. The Commission considers, however, that Australia and New
Zealand have the same desire to achieve high standards of food safety and we see
no likelihood that joint activity in this area will be detrimental to New Zealand's
interests. Moreover, collaboration between the two countries allows New Zealand
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to share the cost of a better resourced and equipped safety assessment process
than might be possible if a parallel agency were established and funded internally.
Public consultation
65. A number of submissions raised doubts about the nature and extent of
public involvement in the development of food standards. In its written
submission, ANZFA said that calling for public submissions on food standards
applications is a requirement under the Australia New Zealand Food Authority
Act 1991. It stated:
Community participation in the development of effective food standards enables:
* the tendering of relevant data not already available to ANZFA
* the views of the community to be presented and understood
* sound decision making following review of all available information
* a form of peer review for scientific and technical matters
* increased accountability and transparency in decision making
* smooth implementation following decision making.
30
66. ANZFA's submission advised that it has developed a Community
Involvement Strategy "which will provide a framework for improved consultation
with the broad range of interested community participants". A consultation
strategy for Maori, including the formation of a Maori Reference Group in July
2000, is intended to facilitate greater participation of Maori in the food standard
setting process.
67. ANZFA stated that the role of the Maori Reference Group is to provide
advice on Maori culture and community processes. The Reference Group will
assist in identifying:
*
food standards issues of significance to Maori
*
strategies for effective communication with Maori
*
strategies to involve Maori in food standards issues
*
projects and research relating to food standards.
68. We understood from Mr Lindenmayer that the Maori Reference Group, in
its meetings to date, has emphasised the significant spiritual role that food plays
within Maori communities and the importance of developing effective and
meaningful relationships and dialogue on issues.
31
The Commission considers it
essential that Maori are closely involved with the development of food standards
because of its fundamental importance to their physical and spiritual well-being.
During the course of our inquiries, we heard much said about the loss of
traditional Maori food. Cheryl Smith (Ngati Apa, Te Aitanga a Hauiti), in the
course of the presentation by Nga Wahine Tiaki o te Ao, emphasised that there is
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an active and ongoing dialogue among Maori about changes to food, including
changes through genetic modification. She pointed out that:
The issues of kai, for example, and the safety of our kai, and the loss of our kai or of our
traditional kai, has been a point of discussion among us from the time colonisation
began. Genetic modification, of course, is yet another issue. What's happened is that we're
finding more and more a need to protect ourselves in regard to growing our own kai and
ensuring the safety of what we actually feed our own children. One of the key
motivations for our people to return to growing their own kai at the moment is the issue
of genetic modification.
32
Labelling requirements
69. Standard A18 Division 2 regulates the labelling of genetically modified
food. ANZFA's written submission said that, under Standard A18 as it stood at the
time of the Commission's inquiry, genetically modified foods must be labelled
regarding the origin and nature of the characteristic or property modified, where:
*
the modification results in one or more significant compositional or
nutritional parameters having values outside of the normal range of values
for the existing equivalent conventional food or food ingredient
*
the level of anti-nutritional factors or natural toxicants are considered to be
significantly different in comparison to the existing equivalent conventional
food or food ingredient
*
the food contains a new factor known to cause an allergenic response in
particular sections of the population
*
the intended use of the food or food ingredient is different to the existing
equivalent conventional food or food ingredient.
70. Following the recommendations of an ad hoc inter-governmental task
force, which included New Zealand representatives, the ANZFSC decided to
extend the labelling requirements of genetically modified food. From 7 December
2001, food will be required to be labelled as being genetically modified where:
*
novel DNA and/or protein is present in the final food; and
*
the food has altered characteristics when compared with its conventional
counterparts.
71. There will be exemptions in relation to:
*
highly refined food where the effect of the refining process is to remove
novel DNA and/or protein
*
processing aids and food additives, except those where novel DNA and/or
protein is present in the final food
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*
flavours that are present in a concentration less than or equal to 0.1% in the
final food
*
food prepared at the point of sale.
72. The amended Standard will allow an ingredient to contain up to 1% of
unintended presence of a genetically modified product without requiring
labelling. In its written submission, ANZFA stated that this provision is not to be
interpreted as a "general threshold".
73. The New Zealand Ministry of Health, in its written submission, said that
this amendment was determined following public consultation in New Zealand
and in Australia in which consumers expressed a desire for comprehensive
labelling. The Ministry said that, in making a decision about the labelling of
genetically modified food, four criteria were used to assess options: meaningful
information, cost of compliance, international trade implications and
enforceability.
33
74. The labelling requirements will be reviewed three years after they are
implemented, in December 2004.
75. Public concerns about the adequacy of the new labelling requirements are
discussed later in this chapter.
Regulatory responsibilities in New Zealand
Genetically modified food
76. At the time of submissions to the Commission, two New Zealand Ministries
had responsibility for matters relating to food. The Ministry of Health had
primary responsibility for managing the relationship with ANZFA, including
contributing to, reviewing and commenting on standards developed by the
Authority and coordinating responses by New Zealand government agencies on
matters related to food standards. The Ministry of Agriculture and Forestry
(MAF) reviewed and commented on ANZFA standards affecting primary produce.
77. Both the Ministry of Health and MAF had roles in international forums,
with MAF coordinating New Zealand's input into Codex Alimentarius decisions.
MAF also had responsibility for policy advice on primary production and
agricultural trade issues and the Ministry of Health provided policy advice on
public health issues.
78. The Ministry of Health was responsible for coordinating the enforcement
of food standards in New Zealand. Complaints regarding actual breaches of food
standards are investigated by designated officers in public health units of
hospitals and health services around New Zealand. The Ministry of Health also
has responsibility for monitoring public health and responding to and identifying
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the causes of outbreaks of ill effects, such as those that occurred as a result of the
L-tryptophan incident in the United States of America.
79. Animal feed is regulated under the Animal Compounds and Veterinary
Medicines Act 1997. Regulations under that Act come into force in July 2001.
Genetically modified animals, if used in the production of food, will be regulated
under the Animal Products Act 1999, which had not come into force at the time of
the Commission's hearings. The written submission from the Ministry of
Agriculture and Forestry stated that the legislative regime under this Act
provides a mechanism for secondary processors to switch between risk-based
management systems under the Food Act 1981 and the Animal Products Act
1999. It also provides for setting standards for genetically modified animal
material or products or ingredients or additives.
34
80. In chapter 7 (Crops and other field uses) we considered the use of animals as
bioreactors for the production of biopharmaceuticals. In that chapter we
recommended that, to avoid such animals entering the food chain, it is preferable
that only non-food animals used should be used as bioreactors. Meat from any
genetically modified animal, regardless of the purpose for which it has been
modified, will require approval by ERMA and ANZFA and will have to satisfy the
labelling requirements before it is allowed to enter the food chain.
Food Administration Authority
81. Since the Commission has completed its public inquiry, the Government
has announced the formation of a separate food safety agency, under the umbrella
of the Ministry of Agriculture and Forestry. Although no details of the new
agency have been released to date, we understand it will assume many of the
responsibilities for food previously undertaken by the Ministries of Health and
Agriculture and Forestry, although epidemiology and other public health issues
will remain with the Ministry of Health.
82. The Commission considers that the creation of a separate agency is
appropriate. We agree with the frustration expressed by the Grocery
Manufacturers Association which said:
Food safety administration and monitoring and enforcement activities of food are
undertaken by a myriad of agencies in New Zealand including the Ministry of Health,
Ministry of Agriculture and Forestry and local authorities. This has long been of
considerable concern to all sectors of the food industry for the following reasons:
* the lack of resources in some situations to carry out the necessary tasks
* inconsistent rulings and interpretations that result from having a multiplicity of
agencies involved
* companies can be subject to many audits.
35
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83. There are a number of responsibilities related to the management and
oversight of genetically modified foods in New Zealand that the Commission
would want to see the new agency undertake. These responsibilities are identified
during the course of this chapter and summarised in paragraphs 208 to 213.
International obligations
84. The written submission from the Ministry of Foreign Affairs and Trade
provided information on New Zealand's international obligations. The Ministry
suggested that participation in the international community was important "for a
small nation like New Zealand, which has limited ability when acting alone to
influence other governments to its advantage".
36
New Zealand is a party to a
number of international treaties and agreements.
World Trade Organization
85. The Ministry's submission included reference to the World Trade
Organization (WTO) and focused on two WTO agreements relevant to genetic
modification, the Agreement on Technical Barriers to Trade (TBT) and the
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS).
The submission pointed out that the TBT Agreement, which embodies the
principle that products from one country should be subject to the same rules as
like products imported from another country, or produced domestically, applies
to technical regulations, including mandatory labelling requirements. The
Ministry commented that the principles under the Agreement were important
considerations in the development of the Standard A18 labelling provisions. The
SPS Agreement, which allows for a country to impose standards in respect of
plant and animal pests and diseases that are necessary to protect a country's
biosecurity (including food safety), also embodies the principle of non-
discrimination between countries.
Codex Alimentarius
86. The Codex Alimentarius Commission (Codex) is the United Nation's joint
Food and Agriculture Organization/World Health Organization body
responsible for setting food standards. The main purpose of Codex is to protect
the health of consumers and to ensure fair practices in food trade. It also promotes
coordination of food standards work undertaken by governmental and non-
governmental organisations. New Zealand was a founding member of Codex,
which now consists of 165 member countries. The submission from the Ministry
of Foreign Affairs and Trade advised that Codex comprises a number of
committees that consider a range of matters related to standard setting.
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Committees with activities on their work programmes that relate to food derived
from biotechnology include:
*
the Ad Hoc Intergovernmental Task Force on Foods Derived from
Biotechnology
*
the Codex Committee on Food Labelling (CCFL)
*
the Codex Committee on Methods of Analysis and Sampling (CCMAS)
*
the Codex Committee on General Principles (CCGP).
87. In 1978, the New Zealand government directed that, where practical, New
Zealand should adopt Codex food standards.
88. Both ANZFA and the Ministry of Health provided information on matters
currently being considered by Codex. The Codex process for finalisation of the
international documents and standards relating to the safety of foods derived
from biotechnology is required to be completed by 2004 and a determination of
labelling standards for genetically modified foods may also take as long to be
completed. The ANZFA submission appended two draft documents currently
being developed by the Codex Taskforce on Foods Derived from Biotechnology,
both of which relate to assessing the safety of genetically modified food. The joint
submission from Vegfed, Fruitgrowers, Berryfed cited with approval the draft
Guideline for the Conduct of Safety Assessment of Foods Derived from Modified Plants.
OECD Task Force
89. In its written submission, ANZFA said that it participates in the OECD
Task Force for the Safety of Novel Foods and Feeds. The Task Force builds on the
work done by the OECD in the 1990s to develop scientific principles for the
safety assessment of products of modern biotechnology.
Inclusion in the global community
90. Inclusion in the international community is one of our common values and
New Zealand's international obligations are important to the country's economic
well-being. Participation in international forums both allows New Zealand to
contribute to the debate about genetically modified food and also keeps current
the knowledge and understanding of officials charged with protecting the safety
of the general public.
91. The Ministry of Agriculture and Forestry and the Ministry of Health held
a joint public consultation meeting on 12 February 2001 at Wellington, and
invited written submissions from interested parties on the work of the Codex
taskforce. Public involvement of this nature in the debate about genetically
modified food should be encouraged to ensure that the views of the community
are incorporated into New Zealand's responses to the deliberations of
international forums.
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92. The Commission is aware of the concern among some of the public that
membership of international bodies such as the WTO may impinge on New
Zealand's ability to exercise self-determination. During the course of cross-
examination, the Dairy Board
37
spoke of the value of the World Trade
Organization and the Board's written submission said:
As a small nation, with little economic and political power, New Zealand is highly
dependent upon the international community of nations respecting the framework of
legally enforceable rules created by the WTO. Any actions which undermine respect for
that system have negative implications for New Zealand.
38
93. Greenpeace discussed New Zealand's international obligations and made
reference to decisions of the Appellate Body of the World Trade Organization in
respect of a number of appeals against restrictions imposed on trade in food.
WTO has been instrumental in providing environmental protections and, only
recently, New Zealand took advantage of the WTO dispute resolution process to
protect important agricultural exports to the United States. We consider that
such cases illustrate the value of membership of the international body, even
where this may involve relinquishing some degree of national autonomy.
94. Membership of the international community requires reciprocity. Exports,
for example, are protected against discriminatory trade practices imposed by
other nations by the provisions of the TBT and SPS Agreements. In return, New
Zealand must not implement statutory requirements that may be discriminatory
against countries from whom we import. The international trading community is
very watchful in ensuring this does not happen. The Ministry of Foreign Affairs
and Trade, for example, pointed out that New Zealand and Australia, along with
the European Union, had been among the first countries to develop
comprehensive labelling for genetically modified foods. Approaches to labelling
differed among countries, with some countries preferring to avoid mandatory
labelling. Assurances had already been sought that the labelling requirement
under Standard A18 were consistent with provisions of the TBT Agreement.
Significant issues
Is genetically modified food safe?
95. Many of the Interested Person groups prominent in the campaign against
genetically modified food, and many of the people who spoke at the public
meetings and workshops, expressed concerns about the risks associated with the
consumption of genetically modified food. A number of scientists from New
Zealand and overseas gave evidence that the insertion of genetic material into an
organism would create unexpected effects that, in food, could have adverse effects
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on human health. For example, in her witness brief for the Safe Food Campaign,
Ms Kedgley identified most of the concerns shared by submitters when she said:
Scientists warn that food with altered genes could introduce a range of unanticipated
health risks to consumers, including increased levels of naturally occurring toxicants,
the appearance of new, not previously identified, undetectable toxicants, reduced levels
of nutrients, the presence of new allergens, the creation of antibiotic resistance,
immuno-suppression and the potential nutritional degradation of foods.
39
96. In addition, some submissions also expressed a belief that horizontal gene
transfer could transfer recombinant DNA from a modified organism to an
unmodified organism, including a mammal. GE Free New Zealand said:
There is also serious concern about the dangers of using genetically engineered viruses as
delivery vehicles (vectors) in the generation of transgenic plants and animals. This could
destabilise the genome and lead to horizontal gene transfer to other species, including
mammals. This risk is known because recent research suggests that disabled viral material
used in recombinant DNA techniques can recombine with other viral material in plants or
in the human or animal gut to produce new active forms of viral material.
40
97. Scientific witnesses, such as Dr Beatrix Tappeser, a molecular biologist
with the Institute for Applied Ecology at Freiburg and a witness for the Pacific
Institute of Resource Management, and Dr Mae-wan Ho, a witness for GE Free
New Zealand, as well as members of the Physicians and Scientists for Responsible
Genetics, provided evidence about the risks of genetically modified food,
including the possibility of horizontal gene transfer to humans through the
consumption of genetically modified food. Together with many other submitters,
these witnesses stated that, because of lack of experience with modified foods, the
risks could neither be known nor predicted. They called for foods to be subject to
tests similar to those undertaken in relation to pharmaceuticals and suggested
that, until genetically modified food could be shown to pose no risk to human
health, all modified foods currently offered for sale should be removed from sale.
The view was expressed that, in the absence of adequate testing, humans were
being used as "guinea pigs".
98. One of the more publicised and controversial research projects was that
carried out by Dr Arpad Pusztai and Dr Stanley Ewen into the toxic effect of
inserting lectin genes into potatoes. Witnesses such as Professor John Mattick of
the University of Queensland, a witness for Auckland UniServices [IP23],
maintained the study was flawed. Dr Pusztai and Dr Ewen appeared before the
Commission as witnesses for Friends of the Earth, and the Commission had the
opportunity to ask questions about their research.
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Pusztai's Potatoes ­ the controversy
41
Dr Arpad Pusztai, a senior scientist at the Rowett Institute, Aberdeen, Scotland, came to
international attention when he announced to the media that eating genetically modified
potatoes depressed rat immune systems and caused changes in their intestinal tract.
Dr Pusztai and his colleague, Dr Stanley Ewen, tested the dietary effects of potatoes
genetically modified to contain and express a gene for snowdrop lectin, called Galanthus
nivalis agglutinin (GNA).

Lectin was introduced to potatoes as an insecticidal protein, but is
also an antimetabolite, ie it slows down cell growth.
Dr Pusztai and co-workers compared rats fed genetically modified potatoes with those
eating non-modified potatoes, with and without added GNA. The genetically modified
potatoes appeared to cause changes in the rats' immune response and the structure of the
intestinal lining. They asserted that this outcome was the result of the way the lectin gene
had inserted into the potato genome, rather than the expression of lectin by the potatoes.
While the experimental design appears to be correct for this type of feeding study, there were
difficulties with the use of a raw potato diet. Rats do not like to eat raw potato, and a
standard 110-day trial had to be abandoned after 67 days, because the rats were starving.
Starvation affects gut histology, and the lining of the gut of control rats eating unmodified
potatoes was shown to be abnormal. This led to confusion regarding the significance of
Dr Ewen's histological results, particularly to the reported `over growth' of gut epithelial
cells of rats eating genetically modified potato. The presence of other potato toxins could
also have had a confounding effect on cells in the intestine, especially since the potato lines
were not substantially equivalent:
"... we couldn't come to any other conclusion but this, that the GNA gene insertion into our potatoes
induced changes in the levels of all these things ... So we had to say at the end, the GNA GM
potato lines were, therefore, not substantially equivalent to the appropriate parent tubers. And I can
take it further, that the two lines of genetically modified potatoes were not substantially equivalent to
each other".
42
It is also noteworthy that evidence used by Dr Pusztai to indicate that the rats had depressed
immune systems was not the result of standard immune response tests.
Within the scientific community there is general agreement that the results of Dr Pusztai's
experiment are inconclusive insofar as there were flaws in the process, and the project was
incomplete. Extensive testing carried out by Chinese researchers, similar to that described by
Drs Pusztai and Ewen, has not replicated their results.
99. The Commission, having heard evidence directly from Dr Pusztai and his
colleagues, is also of the view that the results are inconclusive. It was unfortunate
that the process of peer review was pre-empted by premature media release, thus
preventing further scientific assessment.
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100. Although evidence was presented about the risks of genetically modified
food, we also heard that risks have been overestimated. Many witnesses pointed
out that, although genetically modified food had been available internationally
for over a decade, there was no evidence it had caused harm. The Grocery
Marketers Association considered that:
If very little was known about genetically modified foods, even a suspicion of harmful
effects might deter their being marketed. But a considerable amount is known, which has
allowed regulatory agencies around the world, such as the OECD, the WHO, FDA, to state
that genetically modified foods are as safe as conventional foods.
43
101. Dr Brian Jordan, Director of the Nutrition and Health Institute of Food,
Nutrition & Human Health at Massey University, a witness for the New Zealand
Arable-Food Industry Council [IP56], said:
Of particular concern to the public is the ability of this new technology to supply
consistently safe food. This concern has been addressed many times recently by a number
of world organisations, such as the OECD, FAO and Codex Alimentarius. The overall
conclusion is that there are no credible reports of adverse health effects from consuming
GM foods. For instance, the OECD conference held in Edinburgh in March 2000 on "the
scientific and health aspects of genetically modified foods" concluded that GM food was
not a health risk.
44
102. HortResearch [IP5] also suggested that there were no risks associated with
the genetically modified foods available in New Zealand. Its written submission
said:
While everyone should have the choice as to what they eat, there are no known health
risks associated with eating GM-sourced foods available in New Zealand under current
legislation. ... Most people take a far greater risk every day in eating food potentially
containing pathogens like Salmonella or Campylobacter. The apparent high level of
public concern about the safety of GM foods is based more on a range of other concerns
(such as moral and ethical issues) rather than on the technical risks to food safety.
45
103. Many of the submissions were concerned about the relationship between
antibiotic resistance marker genes and increased human resistance to antibiotics.
As discussed in chapter 4 (Environmental and health issues) and chapter 6
(Research), the Commission considers increased antibiotic resistance has resulted
from a combination of factors, including the overuse of antibiotics in medicine,
other than the use of antibiotic marker genes. However, given the increasing
frequency of antibiotic resistance, we would encourage the use of alternative
strategies to antibiotic resistance marker genes in the development of transgenic
organisms.
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104. The Commission was told that food retailers overseas are responding to
consumer concerns by refusing to sell produce such as meat, poultry, milk and
eggs coming from animals or birds fed on genetically modified feed, and by using
positive labelling mechanisms such as "organic" or "GE Free".
105. None of the organisations involved in the research and development of
food crops or in food production and distribution, however, suggested that the
safety of genetically modified food should be assumed. They supported ANZFA's
view that, in the absence of a history of safe use:
... a cautious approach is applied to these foods that involves scientific risk assessment
prior to their being permitted for sale in the food supply.
46
106. The Commission considers this to be the appropriate approach to follow.
Witnesses said that there may be risks associated with the application of gene
technology to food. While we accept that, to date, there has been no evidence of
unsafe foods entering the New Zealand market, we are conscious that there is
always a possibility of adverse effects from unsafe food. We are aware of the
serious concerns about the long-term effects of food on human health raised by
the incidence of BSE. At the same time, we are in agreement with the statement
made by the New Zealand National Commission for UNESCO [IP90] that:
... if genetic engineering can lead to increased productivity of crops, growth rates and
usable plant product; quality of crops including nutritional quality and storage
properties, adaptation of plants to specific environmental conditions, a broadening of
plant tolerance to environmental stress; increase in disease and pest resistance and less
need for the use of agrochemicals; production of substances in food crops of importance
to human health and the utilisation of hitherto unused species for human consumption,
then these benefits for humanity cannot be foregone.
47
107. Many witnesses said that the "second wave" of genetically modified foods
will have greater direct benefits for consumers. We do not, therefore, consider it
would be in the best interests of New Zealand to ban genetically modified food.
We do, however, consider that consumers should be protected by rigorous
scientific assessment processes and by proactive and effective post-market
monitoring systems, and should also be able to exercise their own choice as to
whether or not they consume genetically modified food.
108. Organisations such as the Safe Food Campaign suggested that a prohibition
on genetically modified food and a thrust to make New Zealand "an organic
nation" would lead to increased consumption of organic food with a
commensurate improvement in public health.
48
We have seen no evidence to
support this assertion. We acknowledge the importance to people of being free to
choose food produced through a process they consider to be safe. Based on the
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evidence we heard, we see no reason to assume that the continued presence of
genetically modified foods assessed to be safe by the appropriate regulatory body
will prevent individuals being able to exercise their choice to eat organic food.
Steps should be taken, however, to avoid the contamination of organic food crops
growing in New Zealand and this is discussed in chapter 7.
Unapproved genetically modified food
109. Several submissions expressed concern that ANZFA had permitted
genetically modified food to remain on sale in New Zealand pending the
completion of safety assessments. Sue Kedgley, on behalf of the Green Party and
the Safe Food Campaign, cross-examined Mr Lindenmayer on the ANZFA
decision not to require these foods to be withdrawn. She questioned whether, in
the absence of a safety assessment, ANZFA was meeting the obligation under the
New Zealand Food Act 1981 that "food in New Zealand must be safe and must
not contain anything harmful to health".
49
110. In its original written submission, ANZFA advised it was considering 18
applications for approval for the release of genetically modified foods, covering
soybeans, corn, canola, potato, sugar beet and cotton, all but one relating to the
introduction of genetic traits designed to improve production characteristics,
such as a crop's insect resistance or tolerance to herbicides. The other application
related to changes in the oleic acid content of a soybean. The written submission
advised that, on 28 July 2000, ANZFSC approved two genetically modified
foods: glyphosate-tolerant soybeans (Roundup Ready soybeans) and oil and
linters derived from insect-protected cotton lines 531, 757 and 1076 (Ingard
cotton). Ten safety assessments had been completed and sent for final approval to
the Council. Assessments for the remaining six "were at an advanced stage" and
would soon be released for public consultation.
50
111. At the time of the written submission, therefore, only two genetically
modified foods had been approved under Standard A18, although a number were
in the process of being approved. Later, at the hearing before us, Mr Lindenmayer
was asked about the foods that might still be on the market awaiting assessment.
He said:
My expectation is that 18 of them would be on the market ­ market still, of which, I think
it is seven, have already been approved and are therefore under the ongoing regulatory
arrangements. Another group have now gone through the ANZFA Board processes and
recommendations are with ­ or are about to be with the Ministerial Council. And, I think
safety assessments have been completed for all but two, and those two are two in respect
of which we have been requiring further information from the applicant companies in
order to allow us to complete our safety assessment.
51
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112. Because most of the foods approved by ANZFA are used as ingredients, a
list of foods that have been approved does not give a clear picture of the foods on
the supermarket shelves that could be classified as genetically modified. Few if
any of these foods were required to be labelled in accordance with the provisions
of Standard A18, which is currently being extended. Many submitters, however,
suggested to us that the labelling required under the amended Standard A18 will
still not provide the level of information about the use of genetic modification in
food they think is necessary. We consider this issue later in this chapter.
Compliance with Standard A18
113. Submissions raised two situations in which genetically modified foods that
had previously been approved under Standard A18 could cease to comply with
the standard: accidental unnotified changes to gene constructs, and contamination
by unapproved genetically modified products and changes.
Changes to construction of approved food
114. Ms Lees, cross-examining for ECO and Nelson GE Free Awareness
Group, raised with ANZFA the issue of unnotified changes. She questioned
whether the Authority regularly tested for changes in gene constructs and
suggested that, had there been an unexpected change in the gene construct, it
might not have been possible for the applicant to notify ANZFA of this change.
She asked whether, in such a situation, ANZFA could assure the safety of that
food.
52
115. Mr Lindenmayer pointed out that it was ANZFA's responsibility to establish
food standards and to amend the Food Standards Code to indicate approval for
foods. Once approval had been given, responsibility for monitoring and enforcing
standards in New Zealand rested with the Ministry of Health.
Accidental contamination of approved food
116. The StarLinkTM incident (see overleaf) was frequently mentioned as an
example of how the safety of genetically modified foods could be compromised.
Many submitters seemed to see the events as an illustration of the overall lack of
safety of genetically modified food.
117. The Commission does not consider that cases of the accidental
contamination of human food by unauthorised genetically modified material cast
doubt on the safety of all genetically modified food. They do, however, raise
issues about the need for vigilance on the part of regulatory agencies. Many
submitters discussed the possibility of foods available in New Zealand being
accidentally contaminated and were concerned that a complaint would be needed
to trigger action from the responsible regulatory agency.
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118. In New Zealand, enforcement of food standards was, at the time of writing
this Report, the responsibility of the Ministry of Health. It is a function that, we
assume, will be moved to the proposed Food Administration Authority. Given the
level of public concern about the safety of genetically modified food for human
consumption, it is important that the Food Administration Authority, when
StarLinkTM Corn
53
In 1998, and subsequently in 1999 and 2000, the US Environmental Protection Agency
approved for use as animal feed a corn modified by insertion of the Cry9C gene from Bt
encoding for an insecticidal crystal protein endotoxin. The corn was marketed as
StarLinkTM. Because of concern that the protein Cry9C could be allergenic, the Agency
could not find that there was a reasonable certainty of no harm to humans. The corn was
not, therefore, approved for use as human food.
In September 2000, a coalition of environmental and food safety groups announced that
Cry9C DNA fragments had been found in a popular brand of taco shells sold in the United
States. In addition, the Cry9C protein was discovered in some non-StarLinkTM seed corn. As
a result, there was a voluntary recall of corn-derived food products in the United States by
manufacturing companies, some of who took steps, such as mandatory testing requirements,
to ensure no further contamination.
Late in 2000, a further review of the potential allergenicity of Cry9C, and of mechanisms for
assessing suspected allergenic reactions to StarLinkTM corn concluded that the Cry9C
protein had a medium likelihood of proving to be a potential allergen and that seven out of
34 reactions to a meal containing corn products were probably allergic. A definitive
conclusion would have required further studies.
The presence of Cry9C protein in seed corn was thought to be a result of physical contamination,
although cross-pollination from StarLinkTM corn could not be ruled out as the source.
The StarLink incident illustrates a number of issues relating to genetic modification of food
and crops:
* The difficulties of restricting a genetically modified food for use for animals or industrial
purposes when there are almost indistinguishable unmodified counterparts available for
human consumption.
* The difficulty of preventing accidental contamination of human foods by imposing
segregation requirements on modified food crops.
* The difficulty of ensuring adherence to separation requirements to prevent cross-pollination
of genetically modified and unmodified crop species, and the failure of the companies
promoting genetically modified crops to require or ensure proper growing practices.
* The need for appropriate labelling, and for post-market monitoring to identify allergic
reactions rapidly and accurately.
* The externalisation to producers and to consumers of costs created by growing
genetically modified crops.
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established and, until then the Ministry of Health, are proactive in enforcing food
standards and in providing the public with assurance that the safety of genetically
modified food is closely monitored. We are concerned that this appears not to
have been done in the past nor was the capability there to do so.
119. The Ministry of Health advised that genetically modified food is not
routinely tested to ensure compliance with Standard A18. Once the amended
mandatory labelling regime comes into force, the Ministry intends to investigate
substantiated complaints of breach of the Standard, as well as undertaking a
project to look at compliance with the labelling requirements.
54
120. It is not sufficient for the Ministry to rely on complaints before initiating an
investigation. Testing for the presence of unauthorised genetically modified
material in foods is an issue of food safety, not of regulatory compliance. The
Commission notes that the Ministry has contracted the Institute of Environmental
Science and Research to establish and maintain analytical capability to test
genetically modified food. We expect that such tests will be carried out routinely
as part of the Total Diet Survey, which already tests for pesticide residues and
heavy metals in food.
55
The safety of genetically modified stock feed
121. The Green Party expressed concern about the possible risks to animal
welfare and human health from the use of genetically modified animal feed. It
suggested that any products incorporated into animal feed should be required to
undergo well-controlled feeding studies in the target animal comparing the new
plant variety with the conventional plant.
122. The Feed Manufacturers Association, Poultry Industry Association and
Egg Producers Federation were questioned at the hearing on the use of genetically
modified soy and corn meal fed to chickens in New Zealand. In response to
questions from Tom Bennion on behalf of the Green Party and GE Free New
Zealand, John Foulds, speaking on behalf of the Associations, said that he did not
know if any assessment or testing was carried out prior to the meal being used in
New Zealand. In response to questions on the steps taken to source unmodified
feed, the Associations' representatives stated that they experienced difficulty
sourcing feed that could be guaranteed to be free from genetic modification
because overseas suppliers were unable to give such a guarantee. The Associations
also said that, if they were able to source such feed, it would be more expensive.
123. ANZFA acknowledged that concerns were raised from time to time about
the human health consequences of the feeding of genetically modified feed to
animals. It cited information from the Federation of Animal Science Societies
(FASS), an association of three prominent American animal agriculture societies
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(the American Dairy Science Association, the American Society of Animal
Science and the Poultry Science Association), indicating that no DNA and/or
protein could be detected in products such as meat muscle, whole milk, poultry
and eggs from animals or birds fed a variety of genetically modified
commodities.
56
In a report prepared recently for the Ministry of Health, Institute
of Environmental Science and Research reproduced a review by Dr Marjorie
Faust at the Department of Animal Science, Iowa State University, of studies
designed to detect any unintended effects in livestock fed genetically modified
crops. Dr Faust's review stated that conclusions from the more than 40 animal
feeding studies that had been completed or were currently in process had been
consistent in finding no detrimental effects in livestock fed genetically modified
crops.
57
124. ANZFA submitted that possible consequences to human health should be
assessed on a case-by-case basis, taking into account any potential hazards
identified combined with a consideration of the animal feeding practices used for
the particular feed in question. The submission suggested that, if any hazards
were identified during an assessment of genetically modified animal feed,
consideration should be given to the potential human exposure to that hazard
through the use of the feed. Genetically modified stock feed will have to meet the
regulatory standards that come into force on 2 July 2001. These standards require
the importer of stock feed to satisfy the Ministry that the product is safe and fit for
stock feeding purposes. The submission from MAF, however, advised that stock
feeds that are not genetically modified organisms but are the products of genetic
modification may not require an assessment and registration under the Animal
Compounds and Veterinary Medicines Act 1997 (ACVM) if they do not trigger
any safety or risk thresholds.
125. The Commission noted the call for separate testing of animal feed. With
regard to human health, although we heard evidence of potential risk pathways,
particularly through horizontal gene transfer, no evidence was presented of actual
harm to human health. We do not, therefore, consider a mandatory safety
assessment on stock feed should be imposed unless there is evidence of either
novel DNA or other potentially harmful novel material being found in the
products of animals and birds fed genetically modified stock feed.
Recommendation 8.1
that the Food Administration Authority monitor research
studies on stock feed and act on any that indicate a need for
stock feed to be assessed in relation to human health.
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126. Products from animals or birds fed on genetically modified pasture or
stock feed do not require assessment under Division 1 of Standard A18 because
they are not considered to be genetically modified, nor will they require labelling
under the labelling provisions to be implemented later this year. It is important
that consumers are able to choose to avoid consuming the products of animals
and birds fed on genetically modified feed. Where a claim that animals and birds
have not been fed genetically modified food can be sustained, labelling that
identifies the product as being free of genetic modification will be appropriate.
We discuss genetic modification-free labelling later in this chapter. Without
such a label, consumers must assume that a genetically modified food may have
been used.
Are the current food safety standards satisfactory?
127. Those people who worried about the safety of genetically modified food
were also doubtful about the ability of regulatory agencies to identify and manage
the associated risks. Nelson GE Free Awareness Group referred to the anxiety of
environmentalists and said:
Many are extremely concerned over the lack of adequate testing carried out by the
regulatory agencies and multinationals and the rapid introduction of foods from this
technology reaching the supermarket. The public wish to preserve their health and
understand that their consumption of safe, nutritional food is the best way to ensure
continued health.
58
128. Joanna Gamble referred to the importance of consumer confidence in
regulatory agencies in the background paper provided for the Commission on
public perceptions of genetic modification. She pointed out that a 1998 study
conducted with focus groups by HortResearch revealed that, because consumers
were reliant on particular organisations (ANZFA, governmental) to provide
them with information on the use of genetic modification, a high degree of trust
in those entities was required for the information to be accepted.
59
129. As the regulatory body most closely identified with responsibility for
ensuring the safety of genetically modified food, ANZFA attracted considerable
criticism from those submitters who were concerned about the safety of the
technology. During the public hearings, and in written submissions, the
Commission heard serious allegations about the inadequacy of ANZFA's
processes and standards. The Authority was, therefore, invited to appear before
the Commission and respond to criticisms. The hearing was open to the public so
that not only the Commission but also Interested Persons were able to question
the ANZFA representatives. In inviting ANZFA to appear, the Commission
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particularly drew their attention to the strong criticism expressed by the National
Nutritional Foods Association of New Zealand (NNFA) [IP106]. The submission
from the NNFA, and the witness brief from its Executive Director, Ron Law,
referred to events relating to royal jelly (a bee product) and said:
The Australia New Zealand Food Authority is an Australian government agency given
legal authority to set food standards. ANZFA assures the public that it has vigorously
determined the safety of GE product approved to date. The NNFA will provide prima facie
evidence that ANZFA has a track record of using false, falsified and even fabricated data
to establish food standards.
60
130. Mr Law also raised issues about the credibility of the Therapeutic Goods
Administration (TGA), the Australian equivalent of Medsafe, which is discussed
in the following chapter on Medicine. Mr Law said:
Based on the NNFA's experience with the regulatory process, New Zealanders can have zero
confidence in ANZFA, TGA or the Ministry of Health regulating GE products in an
objective, transparent and equitable manner that is commensurate with good regulatory
practice.
61
131. The Commission was able to form its own opinion of ANZFA based on
what it heard during the course of the hearing. As will emerge in the conclusions
later in this chapter, the Commission does not share Mr Law's views.
132. The doubts we heard expressed about the quality of the safety standards
applied to genetically modified food tended to focus on the following issues:
*
lack of independent testing of genetically modified foods by ANZFA
*
reliability of the scientific data on which safety assessments are based
*
reliance on Food and Drug Administration (FDA) approval
*
testing standards applied to determine the safety of genetically modified
food
*
application of a "substantial equivalence" test to determine whether or not
a modified food was safe
*
adequacy of scientific knowledge of the effects of genetically modifying
food.
Lack of independent testing of genetically
modified food
133. Concern about the lack of independent testing arose primarily from doubts
about the integrity of applicant companies and the reliability of any information
they would supply. For example, GE Free New Zealand said:
ANZFA regulations do not contain provisions for independent testing of the safety of
novel foods. ANZFA relies on the assessments and submissions provided by the
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manufacturers and regulators in the country of origin of the novel foods. This process is
open to abuse. It is a highly risky method of assessing safety as the manufacturers have
commercial reasons for hurrying their products to market and may cut corners with
safety testing and assessment.
62
134. ANZFA confirmed that it does not carry out any scientific testing of its own
but, in the absence of internationally agreed guidelines, followed an assessment
process based on recommendations from internationally recognised
organisations such as the OECD.
63
135. During the hearing, Mr Lindenmayer pointed out that the cost of testing at
product level would be "vast". Moreover, he questioned whether independent
testing would add anything significant to the assessment process. Any testing that
would be carried out would be more limited and would:
... raise the question of what more should be tested for than what is already tested for by
the applicant organisation in gathering the data for the data packs.
64
Reliability of the scientific data provided by applicants
136. There was also concern that ANZFA based its assessment on scientific data
put forward by applicant companies involved in developing and promoting
genetically modified food. It was suggested that the data was not reliable because
it had it not been peer reviewed or published, nor was it tested by ANZFA.
Dr Judy Carman, an epidemiologist and immediate past-president of the South
Australian Branch of the Public Health Association of Australia, who appeared as
a witness for Pesticide Action Network New Zealand [IP87], said:
one of the concerns of course is that the information that comes to ANZFA now only
comes from the applicant company; there are no independent safety assessments done
that ANZFA can collect that they can look at. This is a worry because clearly the company
is going to benefit financially from the food if it is assessed as being safe, yet ANZFA
appear to be accepting their safety evidence without discount, and in the complete
absence of produced independent assessments.
65
137. ANZFA staff provided considerable detail about the scientific data and
information used by the Authority in the course of its scientific assessment.
Dr Marion Healy, ANZFA Chief Scientist, discussed the scientific information
used in carrying out assessments. She stressed that the information requirements
ANZFA set outs in publicly available guideline documents are indicative only
and that ANZFA reserves the right to require additional information if necessary.
Dr Paul Brent, ANZFA's Manager (Biotechnology) advised that:
... of the 18-odd assessments done so far, there wouldn't be one where we haven't gone
back on many occasions to the applicant and challenged them to clarify bits and pieces
of applications, particularly the molecular characterisation.
66
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138. Dr Healy commented that the quality of the data presented with an
application was a critical part of the evaluation process. She said that, when
assessing the quality, ANZFA took into consideration matters such as:
*
the relevance of the data to the hazard, the food and the consumption of the
food
*
the appropriateness of the methodology: is it up-to-date? has it been
validated?
*
the adequacy of the study design, including the length and sufficiency of the
testing, whether or not there is a dose response curve
*
the appropriateness of any relevant statistical analysis
*
the reproducibility of the data
*
the totality and the weight of the evidence.
67
139. Dr Healy emphasised that totality and weight were key factors in assessing
the safety of a food, rather than individual studies alone. She told the Commission
that, in situations where there is scientific uncertainty, a number of additional
steps are built into ANZFA's risk and safety assessment process, such as:
*
determining whether a pre-market product-by-product assessment should
be carried out or whether general permissions should be given
*
determining whether case-by-case assessments or generic assessments
should be carried out
*
the scope and relevance of the data, including issues relating to the veracity
of the data, its sources, its production
*
the relevance of the data to the target population
*
modelling the exposure scenarios.
140. Dr Healy stated that the higher the level of uncertainty, the more
conservative would be ANZFA's approach to modelling the exposure scenarios.
She also commented that, in determining any appropriate risk management
strategies, ANZFA would also be more conservative according to the level of
uncertainty in the information.
68
141. Dr Brent provided further information about the data on which ANZFA
based its recommendations. He advised that, as part of the application, the
Authority received the raw data from every experiment conducted by the applicant,
which, he suggested, allowed for a more rigorous analysis than could be done on
the summary data submitted in support of publication of a scientific journal
article. Dr Brent also emphasised the quality expected, saying:
... for the data to be accepted as reliable, relevant studies must be conducted using
internationally accepted protocols for research, such as good laboratory practice, and
they are usually independently audited.
69
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142. Dr Brent advised that data was required on:
*
how the food was developed, including the molecular biological data which
characterises the genetic change:
­ data on the donor, the host, the method of transformation
­ the full sequence of the gene construct and the vectors
­ regulatory elements, construct maps, number of insertion sites
­ information on the stable inheritance over generations
*
data on the composition of the novel food compared to the non-modified
counterpart foods:
­ nutritional information
­ potential for toxicity and allergenicity.
143. Following the hearing, Commission members had the opportunity to read
documentation presented in support of an application for approval of Roundup
Ready Soybeans.
70
From our reading of these 15 substantial volumes, and also
documentation relating to other genetically modified food applications, we
conclude that ANZFA required comprehensive studies, including raw data, and
did not rely on the conclusions reached by the applicant company's own employees
or contractors. We consider that the ANZFA staff is well qualified to analyse the
data and to assess the safety of genetically modified food based on current
scientific knowledge.
Provision of false information
144. At the hearing, the Commission raised with ANZFA staff the possibility of
false information being supplied by applicant companies. The Commission
asked whether the Authority could be certain that false test results had not been
given, and also queried whether there was a risk that the applicant might suppress
unfavourable test data.
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145. Dr Healy replied it was not hard for an experienced scientist, knowledgeable
in the relevant discipline, to identify a "disjunction" between the data presented
and what the body of scientific literature says should occur. In response to the
second question, Dr Brent agreed that suppression of unfavourable test results by
a company would be difficult to detect. Mr Lindenmayer pointed out that not
only were regulatory bodies, such as ANZFA and ERMA, developing systems for
exchanging information but also it was likely that such behaviour would become
public. He reminded the Commission that companies wished to protect their
reputations.
Reliance on FDA approval
146. A number of submitters were particularly concerned that ANZFA had
approved the entry of genetically modified food to the New Zealand and
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Australian markets on the basis of prior approval by the United States Food and
Drug Administration (FDA). ECO said:
ANZFA needs to investigate more fully the actual testing that has been done on the foods
approved. They should not rely on FDA testing, as the FDA has been shown to ignore its
own scientists' advice and a "revolving door" between industry employees and the FDA
has been documented. This calls into question the impartiality of the FDA's decisions.
When ANZFA's decisions are contrary to the New Zealand public's wishes, then New Zealand
should be free to make independent decisions based on public preferences.
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147. Steven Druker, a witness for the Nelson GE Free Awareness Group, gave
further details of the doubts about the FDA. Mr Druker, an American public
interest attorney, who was representing nine scientists in a lawsuit against the
FDA, related a number of concerns about genetically modified food, and also
questioned the soundness of FDA policy, which he described as "irresponsible
and immoral".
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148. At the hearing before the Commission, the Authority was questioned on
two occasions about its reliance on FDA approvals during the course of safety
assessments. Questions from GE Free New Zealand specifically addressed this
issue:
MR COLLINS QC: In undertaking the assessment, to what extent was there reliance on FDA
prior approvals?
DR BRENT: There was no reliance on the approvals. They don't do a pre-market safety
assess, so we've never used any evidence from the FDA as part of our approvals.
MR COLLINS QC: Yet there are many many foods that were introduced into New Zealand and
Australia which were approved because they were authorised by FDA?
DR BRENT: No, that's not correct. I think you will find in the interim arrangements we use
the words "regulatory authorities".
MR COLLINS QC: Yes.
DR BRENT: And that would include the UK, the EEU, Japan and Canada.
MR COLLINS QC: Not the FDA?
DR BRENT: The FDA has never been in a position ­ or we have never used the FDA as a
standpoint to base our safety assessments. They don't do one.
MR COLLINS QC: So you are able to categorically assure the Commission that there has been
no reliance placed on "FDA approval", if I can use that word in quotation marks, in giving
approval to a food introduced into New Zealand or Australia as part of that interim
regime?
DR BRENT: Not for a GM food, no.
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149. Later in the hearing, after a brief discussion on whether the FDA had a
voluntary or mandatory notification process, the Commission asked for
confirmation of the relationship between FDA and ANZFA approval:
CHAIR: So, whether it was at the voluntary stage or at the more recent mandatory stage,
the fact that something has been submitted to the FDA, plays no part in ANZFA's decision-
making?
DR HEALY: That's right. Obviously we monitor what's going on at regulatory agencies as
well as the scientific literature around the world and we're well aware of the types of
products that are being discussed with the FDA, as we are with a number of other
regulatory agency. But, the decision, or the kind of discussions that the FDA are having,
do not directly at all impact on the sort of decision-making that we at ANZFA have. If they
alerted us to a particular problem then obviously we would take cognisance of that
information as with any piece of information that we derive from anywhere; regulatory
scientist, wherever, to make us look a bit more closely at what the issue was.
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150. The Authority went on to state that the fact that a food had been on the
market in a country other than New Zealand for a significant period without
adverse effects would be one of the factors taken into account in the decision-
making process.
151. The Commission was satisfied that reliance on FDA approval does not, on
its own, play a role in either the scientific assessment process or the overall
process for making decisions on applications under Standard A18.
Standard of ANZFA safety assessments
152. Many of the submissions we received questioned whether ANZFA's safety
assessment process was adequate to provide an assurance of the safety of approved
genetically modified food. In its written submission, GE Free New Zealand said:
The Environmental Risk Management Authority (ERMA) and the Australia New Zealand
Food Authority (ANZFA) are operating case-by-case assessments of biotechnology food
products whereby most gene-altered foods are passed as safe with minimal testing and
sold to the unsuspecting public without health warnings to identify these novel food
risks. The safety assessment procedures involve no long-term health testing of novel
foods. Therefore the ERMA and ANZFA regulatory framework is prima facie inadequate to
protect consumers from health hazards.
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153. Moreover, Dr Carman in her evidence suggested that ANZFA has:
... as a philosophy the idea with genetically engineered foods that they are safe until
they are proven to be unsafe.
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154. During the course of the hearing, Dr Healy and Dr Brent described in some
detail the process ANZFA followed in carrying out safety assessments. Dr Healy
described the risk assessment, safety assessment framework within which
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decisions on the safety of novel foods are made and the policy considerations
relating to decision-making in respect of those foods. She told the Commission
that a safety assessment is viewed as a modified form of hazard identification and
is a comparative approach, aiming to identify new or altered hazards relative to
the comparator and to identify changes relevant to human health in relation to
key nutrients. She mentioned that assessments of genetically modified foods also
took into account the potential dietary exposure of the foods.
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155. In discussing the safety assessment process, ANZFA staff stressed the
qualifications and scientific experience of its own staff. There were five staff on
the scientific side, in addition to the Chief Scientist. ANZFA also confirmed that
it used external scientists for specific assessments. A list of names was included in
the additional information the Authority provided in response to criticisms made
of it during the course of our inquiries.
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156. We were also advised that, before any recommendation is forwarded to the
Ministerial Council (ANZFSC) for approval, there is opportunity for comment,
including comment on the science, from a range of people with knowledge of
food safety issues. These included internal and external peer reviewers, the senior
health officials of all the jurisdictions covered by the ANZFA process, and Health
Ministers on the Council.
157. Dr Carman stressed the importance of public health expertise in the safety
assessment process
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and during the course of cross-examination Ms Kedgley
questioned the public health expertise of ANZFA staff. Dr Healy responded that,
in addition to the staff with molecular genetic qualifications, ANZFA staff had a
range of qualifications, including qualifications in nutrition and public health.
Mr Lindenmayer confirmed that there were a number of external sources of
public health expertise available to the Authority.
158. In response to a question from the Commission, Dr Healy discussed what
might constitute scientifically reasonable grounds for withholding approval for a
genetically modified food. She identified allergenicity as being a particular
ground for withholding approval, as well as evidence of abnormal toxins. She also
mentioned that a deliberate nutritional modification might create issues about
any consequent alteration to the impact of particular nutrients in the nutrient
profile in the context of diet, and confirmed that the Authority would have
particular concern about the potential for the production of a protein of unknown
function or unknown impact.
Use of "substantial equivalence" as a test for safety
159. Several of the Interested Persons expressed concerns about the use of
substantial equivalence as a test for the safety of genetically modified food. The
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Safe Food Campaign, for example, said it believed that:
... substantial equivalence testing jeopardises consumer safety by allowing the quick
introduction of GM foods into the human diet without adequate testing. We believe that
ANZFA should not be approving these recently and relatively developed untested
products to be consumed. The lack of safety testing and the labelling of GM foods we
believe does not address the risks surrounding GM foods, and does not adequately
protect consumers, or provide them with adequate opportunity to avoid GM foods.
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160. As well as listening to ANZFA's comments on this issue, the Commission
considered the views expressed by the Expert Panel of the Royal Society of
Canada.
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We noted also the discussion of approaches to the nutritional and food
safety evaluation of genetically modified foods contained in the report of the
meeting of a joint FAO/WHO Expert Consultation on Foods Derived from
Biotechnology held towards the middle of 2000.
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161. The report from the Royal Society of Canada explored the uses of
"substantial equivalence