| Issue |
Scientific convergence
|
Scientific divergence
|
Gaps in knowledge
|
|
Issue 1: Safety of GM foods for human consumption
Overview
|
Present GM foods on market are
considered safe for human
consumption. (FAO/WHO 2000; 2001a)
No documented cases of ill effects from GM food
consumption. (OECD 2000a,b; 2001a)
|
|
Long term effects unknown for GM
foods, as well as most foods. Difficult to detect long-term effects due to
many confounding factors and genetic variability in foods and related
effects in the population. (Kuiper
et al 2001) |
| Risk issues for GM food safety
assessments Increased risks of allergenic
and/or toxic compounds in foods due to presence of newly inserted proteins
or marker genes. |
Gene technology may increase
or decrease
levels in food of naturally occurring allergenic proteins or introduce new
proteins or other compounds with potential for allergenic, toxic or food
intolerant reactions.
If any increased levels of allergens or potential new allergens detected,
the product is not commercialized.
Transfer of genes from commonly allergenic foods is discouraged. (FAO/WHO 2000)
|
|
Proteins from sources not
previously used in human food are more difficult to assess for safety.
Present methods compare new protein with known allergens
and also test for heat stability and enzyme digestibility. If new protein is heat unstable and easily digestible, low allergenic risk.
Heat stable proteins pose higher risks of allergenicity. (Lehrer, 2000;
FAO/WHO 2000, 2001).
Any increases in pollen allergenicity should be checked. (RS) |
| Antibiotic resistance
development in human and/or animal pathogens. |
Minimal risk of antibiotic markers increasing
antibiotic resistance in human and animal pathogens. Antibiotic markers are being phased out in response to
consumer concerns. (FAO/WHO 2000; OECD 2001a)
|
|
|
| Unintended effects
|
Unintended food compositional changes
may occur during genetic improvement, by conventional plant
breeding and/or by gene technology. Effects detected by chemical analysis
of known nutrients and toxicants (targeted approach). |
|
Possibility
of unintended effects may increase in plants with extensive genetic
modification and altered biochemical pathways, producing new products with
modified nutritional content (eg vitamins, starch, oil content).
|
| Horizontal gene transfer from GM
foods to human/animal gut microflora |
Horizontal gene transfer to gut
microflora may occur, at low frequency. |
|
Risks need to be assessed on
case by case basis. New profiling/finger-printing techniques may be useful
(non-targeted approach) to assay whole foods (Kuiper
et al 2001).
|
| Issue
|
Scientific
convergence |
Scientific
divergence
|
Gaps
in knowledge
|
Issue
2:
Adequacy of methods for food safety assessments
Present
products
(Main commercial products approved are corn, soybean, rapeseed, potato,
papaya and tomato modified for insect
resistance, herbicide
tolerance, virus resistance
and/or delayed ripening).
|
Present
risk assessments based on concept of substantial equivalence as
part of a safety evaluation framework.
This concept considers the existing food supply is safe based on a
history of safe use, although many foods contain anti-nutrients and
toxicants that can cause deleterious effects at certain levels and modes
of consumption.
Several inter-governmental panels satisfied with present approaches used
to assess safety of GM foods in commercial use today. (e.g.
FAO/WHO, 2000, 2001a,b OECD
2000)
National
food safety systems have approved selected GM foods for human consumption
and/or animal feed (e.g. Argentina, Australia, Canada, China, South
Africa, Spain, UK, USA).
|
Consensus
needs to be established on the practical applications of substantial
equivalence concepts (Kuiper
et al 2001)
Precautionary
approaches t risk assessment
require that in areas of uncertainty there should be evidence of no harm.
|
|
|
Future
products
Plants
may be genetically modified to change complex traits such as taste,
aroma, and/or nutrient content.
New products may
result from extensive modification of biochemical pathways, addition of
new pathways, and/or modified toxin-producing pathways.
|
Comparative safety assessments are used to establish degree of
substantial equivalence with most appropriate counterpart.
Compositional
analysis of key components (nutrients and toxicants) as well as phenotypic
and agronomic characteristics of the GM plant is the basis of assessment
of substantial equivalence.
A GM food
may be considered:
(1) substantially equivalent;
(2) substantially equivalent except for the inserted gene;
(3) not equivalent at all.
Food
safety assessment strategies need to be developed on case-by-case basis,
with the extent of risk assessments being proportionate to the likely
risks involved (OECD consensus docs).
|
The extent of food safety
assessments required for specific cases is debated.
If substantial equivalent (SE) – no further testing is required.
If SE except for one trait further safety testing concentrates on
this trait, and its potential for increased toxicity, or allergenicity,
gene transfer to gut microflora, and other risk factors (Kuiper
et al 2001).
|
New
profiling finger-printing techniques
need to be further developed and validated to assess content of whole
foods. The interpretation of data from whole foods analyses, to assess
significance of any compositional changes in foods needs to be refined (Kuiper et al 2001, IUNS/IUTOX 2002) |
|
|
|
|
| Issue
|
Scientific
convergence
|
Scientific
divergence
|
Gaps
in knowledge |
|
Issue
3: Benefits of GM Foods
Direct
health benefits
Nutritionally improved foods
Starch
content
|
Improving nutritional content of foods is scientifically possible (eg
Vitamin A in rice and Indian mustard).
Micronutrient content can be varied genetically (eg iron in rice) (IUNS/IUTOX
2002)
Oil content of rapeseed modified to increase lauric acid content.
Starch quantity and quality can be modified, to increase the glycemic
index of foods (eg barley)
|
Need to demonstrate nutritionally significant levels of vitamins and
minerals are genetically expressed and nutritionally available in new
foods, and that there are no unintended effects (IUNS/IUTOX
2002) |
Benefits need to be better documented.
ISAAA 2001, 2002a,b.
|
|
Pest/
disease tolerant crops
Less
chemical pesticide use
Less mycotoxins in food (potential carcinogens).
Less toxins in food
|
Substantial reductions in pesticide use on broad acre crops (CAST 2002 )
Mycotoxin levels
reduced in Bt corn
Toxin
levels may be reduced experimentally (eg cassava with lower cyanide
levels)
|
|
|
| Vaccine
and/or
pharmaceutical
production in crops
|
Vaccines
able to be produced in crops. |
|
Additional
crop management and regulatory issues involved for crops used to produce
pharmaceuticals and/or industrial products in order to keep them out of
the human food chain. |
| Issue |
Scientific
convergence
|
Scientific
divergence
|
Gaps
in knowledge
|
|
Issue
4: Identification of GM foods
Post-market surveillance
|
Safety of food needs to be determined before new foods are approved for
market, rather than seek to monitor after effects.
|
Post
market surveillance difficult and may not yield useful data on long-term and/or
unintended effects, due to dietary complexity and genetic variability in
the population.
|
May
be useful for following allergenic or food intolerance reactions in
specific parts of the population.
|
| Labelling
|
|
Labelling
can inform consumers on the content,
as well as on the process itself.
|
|