Transcript PowerPoint-Präsentation

Universität
Hamburg
US regulation of gm foods
BIOGUM
Dr. Susanne Stirn
Forschungsschwerpunkt Biotechnik,
Gesellschaft und Umwelt (FSP BIOGUM)
Universität Hamburg, Ohnhorststr. 18,
22609 Hamburg
[email protected]
US regulation
Universität
Hamburg
BIOGUM
Basis of regulation:
 Process of biotechnology poses no special risks.
 Foods derived from biotechnology should be
regulated in the same way as traditional foods.
Therefore:
 The same laws are applicable.
 Three federal agencies have responsibility:
 US Department of Agriculture (USDA)
 Environmental Protection Agency (EPA)
 Food and Drug Administration (FDA)
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US Department of Agriculture
(USDA)
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 Basis of regulation:
Protecting the US agriculture from agricultural
pests and noxious weeds (Federal Plant Pest Act)
 Gm plants:
All plants carrying DNA from an organism
considered to be a plant pest (Agrobacterium,
CaMV) are defined as “regulated articles”.
 Stepwise procedure for deliberate release of gm
plants:
 Field trial authorisation (physical confinement),
 Determination of non-regulated status (required for
unrestricted release and movement in the US).
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USDA
[2/3]
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 A petition for nonregulated status must consider:
 harm to other organisms (beneficial & non-target org.),
 increase in weediness,
 adverse effects on the handling, processing or
storage of commodities,
 threat to biodiversity.
 No tests requirements laid down in the Federal
Plant Pest Act.
 Generally performed tests to exclude toxic effects:
 data from field experiments on the lack of toxic effects on
animals (counting),
 comparison of the nutritional composition with a
conventional counterpart.
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USDA
[3/3]
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61 gm plants are no longer regulated by USDA
(August 2003). These include:
 10x maize (HT, IR),
 10x tomatoes (PQ),
 4x soybeans (HT),
 4x oilseed rape (HT),
 3x cotton (HT),
 3x potatoes (IR, VR).
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Environmental Protection Agency
(EPA)
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 Basis of regulation:
Manufacture, sale and use of pesticides;
environmental safety as well as
tolerance levels for presence in foods
 Gm plants:
Substances produced in a living plant to control
pests (plant-incorporated protectants [PIPs]) (e.g.
Bt-toxins, viral proteins)
 In general, the data requirements for a registration
of PIPs are based on those for microbial
pesticides.
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EPA
[2/3]
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 These general data requirements include:
 product characterisation,
 mammalian toxicity (acute oral toxicity),
 effects on non-target organisms (avian, aquatic
species, beneficial insects, soil organisms),
 allergenicity potential (AA sequence homology, heat /
processing stability, in vitro digestibility in gastric
fluids),
 environmental fate, and, if appropriate,
 insect resistance management.
 The exact data requirements for a registration are
developed on a case-by-case basis.
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EPA
[3/3]
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8 plant-incorporated protectants (PIPs) have been
registered by EPA (June 2003):
 Bt Cry IA(b) in maize (2x),
 Bt Cry IA(c) in cotton,
 Bt Cry IIIA in potato,
 Bt Cry 1F in maize,
 Bt K Cry IA(c) in maize (2x),
 Potato Leaf Roll Virus replicase in potato
(Monsanto)
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Food and Drug Adimistration
(FDA)
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 Basis of regulation:
- Whole foods are under post-market authority.
- A premarket-approval is only necessary when
substances are added to foods that are not
“generally recognised as safe” (GRAS)  Food
additive petition.
 Gm plants:
- No pre-market approval necessary.
- All food crops on the market have undergone
voluntary consultations.
- Responsibility (liability) rests with the companies.
 Nevertheless, the FDA developed guidance
documents for the industry.
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FDA
[2/3]
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 Summary information on the following topics are
discussed:
 the source of the introduced genetic material,
 information on the agronomic and quality attributes of the
plant,
 genetic analysis of the modification,
 evaluation of the safety of the newly introduced
proteins
- toxicity (known toxicants, “history of safe use”,
feeding tests)
- allergenicity (AA sequence homology, in vitrodigestibility),
 chemical analysis of important nutrients and
toxicants.
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FDA
[3/3]
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55 consultations on gm plants for human food and/or
animal feed use have been completed by the FDA.
These include:
 14x maize (HT, IR, MS),
 10x oilseed rape (HT, PQ, MS),
 6x cotton (HT, IR),
 5x tomatoes (PQ),
 4x potatoes (IR, VR).
 3x soybeans (HT, PQ).
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US regulation:
different GMOs
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Trait / Organism
Agency
reviewed for:
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Insect Resistance /
USDA
safe to grow
food crop
EPA
safe for the environment and
human consumption (PIPs)
FDA
safe to eat (except for PIPs) and
wholesomeness
Herbicide tolerance /
USDA
safe to grow
food crop
EPA
use of the companion herbicide
FDA
safe to eat and wholesomeness
Modified oil content /
USDA
safe to grow
food crop
FDA
safe to eat and wholesomeness
Modified flower colour
USDA
safe to grow
ornamental crop
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Safety tests performed by the
companies
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Despite the differences in regulation in the USA and
the EU, the tests on food safety are similar.
 The FDA guidelines are explicitly based on the
“concept of substantial equivalence” of the OECD
and the principles developed by FAO/WHO.
 Most of the gm plants intended for deliberate
release and food use in the EU have previously
been approved in the USA.
 The companies have sometimes performed
additional tests to ensure consumer confidence
(e.g. livestock feeding tests).
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Differences in safety tests between
USA and EU?
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Two interesting argumentation lines of FDA:
 High oleic soybeans (DuPont)
“not materially different ... from soybeans already
on the market”.
 Safety assessment focussed on
 molecular characterisation and
 compositional analysis to exclude unexpected effects.
 No toxicity assessment of the altered oil quality
because of “history of safe use”
(conventionally bred high oleic soybeans and the lack of
known toxicity of oleic acid in other species).
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Differences in safety tests between
USA and EU?
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Not yet decided in the EU. Potential scenario:
 According to the concept of substantial
equivalence “without substantial equivalence”:
 safety assessment of the introduced protein,
 the changed fatty acid profile,
 potential unexpected effects, and
 exposure of consumers (aggregate exposure,
vulnerable consumer groups, bioavailability of
nutrients).
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Differences in safety tests between
USA and EU?
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 Virus-resistant plants (coat protein mediated)
No registration with EPA necessary.
 Long history of human consumption in virusinfected plants (higher virus levels than in transgenic
plants).
 FDA is looking at nutritional composition and
unexpected effects.
 Safety assessment of virus-resistant plants in the
EU?
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Summary
[1/2]
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The regulatory approaches towards gm foods in the
US and the EU are totally different:
 USA:
Gene technology as an extension of traditional
breeding methods
(including mutagenesis, wide crosses and cell fusion)
 no specific laws required
 EU:
Specific risks attributed to genetic engineering
 new regulations implemented for all “genetically
modified organisms” (including all organisms which
can not be obtained by sexual crosses  protoplast
fusion, mutagenesis and wide crosses)
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Summary
[2/2]
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Safety assessments are essentially the same:
BIOGUM
 USA:
Food safety is the interest of the companies due to
unlimited liability.
 EU:
Food safety is determined by government agencies
(main responsibility) with general test requirements
laid down in the regulations.
 Internationally:
Detailed test requirements have been developed
by OECD, FAO/WHO, Codex Alimentarius.
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Ende des Vortrages!
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Summary
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The extent to which more traditional breeding
methods are considered safe is different:
 USA: unintended effects happen also with more
traditional breeding methods (mutation breeding,
wide crosses), breeders have successfully
eliminated plants exhibiting unexpected adverse
effects  no regulatory oversight necessary
 EU: Some of the risks are common to genetic
engineering and traditional breeding methods
(unintended effects)
 regulation for all “genetically modified plants”
(include all plant characteristics which could not be
achieved through sexual crosses)
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US regulation:
Agencies
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Agency
Responsibility
in case of gm plants:
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USDA
plant pests,
gm crop plants with
plant pest risks,
veterinary biologics
All gm plants which are plant pests
or which carry DNA from a plant
pest (CaMV, Agrobacterium) are
defined as “regulated articles”
EPA
microbial pesticides,
plants producing toxic
substances,
plant-incorporated
protectants (PIP)
Substances produced in a plant
through genetic engineering with
the intention to control pests (PIP)
FDA
food, feed, food
Voluntary consultations,
additives, drugs,
guidance on safety tests,
medical devices,
responsibility rests with the
cosmetics
producer
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Toxicity assessment
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Agency
Aim of regulation
Toxicity assessment (what/how)
BIOGUM
USDA
No significant plant
a) Impact on non-target organisms
pest risk should result
from the widespread
planting of GMP
EPA
Safety of PIPs for man
(beneficial, endangered species)
b) field observations,
nutritional composition
a) Impact on non-target organisms
and the environment
(beneficial, birds, fish, honey-
(analogous to bio-
bees, invertebrates)
chemical pesticides)
b) acute oral toxicity, AA sequence
homology with known toxins
FDA
Foods and feed from
a) Impact on humans and animals
GMP should be as safe b) nutritional composition, known
and nutritious as their
toxicants, feeding tests,
parental species
history of safe use
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Allergenicity assessment
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Agency
Aim of regulation
Allergenicity (aim/method)
BIOGUM
USDA
No significant plant
a) worker safety
pest risk from the
b) evaluation based on a
planting of GMP
EPA
literature survey
Safety of PIPs for man
a) Food safety of PIPs
and the environment
b) IFBC-concept:
(analogous to bio-
- amino acid sequence homology,
chemical pesticides)
- in vitro digestibility,
- stability to heat and processing
FDA
Foods and feed from
a) Food safety (except for PIPs)
GMP as safe and
b) allergenic substance not present
nutritious as their
in the new food or
parental species
- AA sequence homology and
- in vitro digestibility
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