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Decision Document DD2002-41
Determination of the Safety of Dow AgroSciences Canada Inc. and Pioneer
Hi-Bred International's Insect Resistant and Glufosinate - Ammonium
Tolerant Corn (Zea mays L.) Line 1507
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This Decision Document has been prepared to explain the regulatory decision
reached under the regulatory directive Dir94-08 Assessment Criteria for Determining Environmental
Safety of Plants with Novel Traits and its companion document Dir94-11 The Biology of Zea mays
L. (Corn/Maize) and Dir95-03 Guidelines for the Assessment of Livestock Feed
from Plants with Novel Traits.
The Canadian Food Inspection Agency (CFIA), specifically the Plant Biosafety
Office and the Feed Section, have evaluated information submitted jointly by
Dow AgroSciences Canada Inc. and Pioneer Hi-Bred International. This
information is in regard to the insect resistant and glufosinate ammonium
tolerant corn line 1507. The CFIA has determined that this plant with novel
traits does not present a significant risk to the environment, does not present
concerns for the safety of livestock consuming feed derived from this plant
with novel traits, when compared to currently commercialized corn varieties in
Canada.
Unconfined release into the environment and livestock feed use of the corn
line 1507 is therefore authorized as of October 10, 2002. Any other corn lines
and intraspecific hybrids resulting from the same transformation event and all
their descendants may also be released, and used for livestock feed, provided
(i) no inter-specific crosses are performed, (ii) the intended use is similar,
(iii) it is known following thorough characterization that these plants do not
display any additional novel traits and are substantially equivalent to
currently commercialized corn, in terms of their potential environmental impact
and livestock feed safety and (iv) that insect resistance management
requirements described in the present document are applied.
Table of Contents
Designation(s) of the PNT:
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Line 1507, OECD identifier DAS-01507-01 |
Applicant:
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Dow AgroSciences Canada Inc. and Pioneer Hi-Bred International
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Species:
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Corn (Zea mays L.)
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Novel Traits:
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Resistance to lepidopteran pests of corn, including European Corn Borer
(Ostrinia nubilalis.), corn earworm (Helicoverpa zea), fall
army worm (Spodopera frugiperda) and black cutworm (Agrotis
ipsilon). Tolerance to glufosinate-ammonium herbicide.
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Trait introduction method: |
Microprojectile bombardment of plant cells.
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Intended use of the PNT:
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Production of corn for human consumption (wet mill products, dry mill products
and seed oil) and oil, meal, grain, silage and other by-products for livestock
feed. These materials are not intended to be grown outside the normal
production area for corn in Canada. |
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Dow AgroSciences and Pioneer Hi-Bred jointly developed a corn line resistant
to certain lepidopteran pests and tolerant to the glufosinate-ammonium
herbicide. The corn line, designated as line 1507, was developed to provide a
method to control yield losses from insect feeding damage caused by certain
lepidopteran pests, and to provide an alternative strategy for weed
control.
Line 1507 was developed using recombinant DNA technology, resulting in the
introduction of bacterial genes conferring lepidopteran resistance and
tolerance to glufosinate-ammonium herbicide.
Dow AgroSciences and Pioneer Hi-Bred have jointly provided data on the
identity of line 1507, a detailed description of the transformation method,
data and information on the gene insertion site, gene copy number and levels of
gene expression in the plant, the role of the inserted genes and regulatory
sequences, and the full amino acid sequences of the novel proteins. Each novel
protein was identified, the mode of action described, characterized and
compared to the original donor bacterial proteins. An evaluation of their
potential toxicity to livestock and non-target organisms and potential
allergenicity to humans and to livestock was provided. Relevant scientific
publications were also supplied.
Corn line 1507 has been field tested in Canada under confined research field
trial conditions from 1999 to 2002. Data generated from field trials in the
United States, Chile and Europe was also used to support the application.
Agronomic characteristics of corn hybrids derived from corn line 1507 such
as seed dormancy, vegetative vigour, early stand establishment, time to
maturity, flowering period, susceptibilities to various corn pests and
pathogens, and seed production, were compared to those of unmodified corn
counterparts.These comparisons contributed to the safety assessment.
The Plant Biosafety Office, CFIA, has reviewed the above information, in
light of the assessment criteria for determining environmental safety of plants
with novel traits, as described in the regulatory directive Dir94-08:
- potential of corn line 1507 to become a weed of agriculture or be invasive
of natural habitats;
- potential for gene flow from corn line 1507 to wild relatives whose hybrid
offspring may become more weedy or more invasive;
- potential for corn line 1507 to become a plant pest;
- potential impact of corn line 1507 or its gene products on non-target
species, including humans, and
- potential impact of corn line 1507 on biodiversity;
The Feed Section, CFIA, has also reviewed the above information with respect
to the assessment criteria for determining the safety and efficacy of livestock
feed, as described in Dir95-03. The following have been considered:
- potential impact of corn line 1507 on livestock nutrition and,
- potential impact of corn line 1507 on livestock
- Corn hybrid Hi-II hybrid (A188 x B73) was transformed with a vector
carrying the synthetic cry1F and pat genes. The plasmid
vector was introduced by microprojectile bombardment into corn embryo tissue.
Transformants were selected based on tolerance to the herbicide
glufosinate-ammonium in the culture medium. Line 1507 was identified as a
successful transformant and was chosen for further development.
- Bacillus thuringiensis var. aizawai is a common
gram-positive soil-borne bacterium. In its spore forming stage, it produces
several insecticidal protein crystals, including the ð-endotoxin Cry1F
protein that is active against certain Lepidopteran insect pests, such as
European Corn Borer. This protein has been shown to be non-toxic to humans,
other vertebrates and non-lepidopteran invertebrates. Foliar insecticides based
on Cry endotoxins (generally known as B.t.) have been registered for over 30
years in Canada and have a long history of safe use.
- A synthetic cry1F gene was developed to maximize its
expression in corn, and introduced into the Hi-II hybrid. The gene codes for a
protein with a high degree of similarity to the B. thuringiensis var.
aizawai insecticidal crystal protein. The protein expressed by B.
thuringiensis var. aizawai is insecticidal to some lepidopteran
species after cleavage in the insects gut to a bio-active, trypsin
resistant core. Insecticidal activity is believed to depend on the binding of
the active fragment to specific receptors present in susceptible insects on
midgut epithelial cells, forming pores which disrupt osmotic balance and
eventually results in cell lysis and insect death.
- The cry1F gene expressed in corn line 1507 is linked to a
constitutive promoter, (ie. results in expression in all corn tissues). Cry1F
protein expression was determined from plants grown in Canada, USA, Europe and
Chile. The levels of Cry1F protein detected in corn grown in these locations
shows a range of values. Differences in protein expression is expected due to
differences in the climate and environments at these locations. Values ranged
from 61 to 348 picograms of Cry1F protein per micro gram of plant protein in
leaf, 126 to 190.5 picograms of Cry1F protein per micro gram of plant protein
in pollen, 37 to 133 picograms of Cry1F protein per micro gram of plant protein
in silk, 550 to 1450 picograms of Cry1F protein per micro gram of plant protein
in stalk and 89.8 to 116 picograms of Cry1F protein per micro gram of plant
protein in grain. The Cry1F protein was shown to degrade readily in the
environment. In soil degradation experiments, Cry1F was found to have a mean
DT50 value (time to degrade to 50% of the original insecticidal properties) of
3.13 days.
- Protein allergens are normally resistant to digestion and heat processing
unlike the Cry1F protein which was shown to degrade readily in simulated
gastric fluid (digested within 1 minute at a molar ratio of 1:100
Cry1F:pepsin), and be deactivated after exposure to 75 0C for 30 minutes.
- The full nucleotide sequence of cry1F and corresponding amino acid
sequence of Cry1F were provided. A search for amino acid sequence similarity
between the Cry1F protein and known allergens which included food allergens, as
well as non-food and wheat gluten allergens, using a database assembled from
the public domain databases GenBank, EMBL, Pir-Protein and SwissProt, revealed
no significant amino acid sequence homologies (based on sequence identity of 8
or more contiguous amino acids). A search of a similarly constructed database
of known toxins indicated no amino acid sequence homologies between known
toxins and the Cry1F protein, with the exception of homologies to other B.t.
insecticidal ð-endotoxins. Additionally, the insecticidal protein was
demonstrated not to be glycosylated, as many known allergens are, providing
additional evidence that Cry1F does not have the properties of known
allergens.
- The inserted, plant expressed cry1F gene codes for a 68 kDa
protein which was compared to the bacterial produced protein and shown to be of
similar molecular weight and immunological reactivity. Matrix assisted laser
desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) was used
to determine the sequence equivalency of the two proteins. The protein showed
similar bioactivity and host range specificity to the native protein.
- Dow AgroSciences and Pioneer Hi-Bred have provided to the CFIA a method for
detection and identification of corn specifically containing the Cry1F
protein.
- Phosphinothricin, the active ingredient of glufosinate-ammonium herbicide,
inhibits the plant enzyme glutamine synthetase, resulting in the accumulation
of lethal levels of ammonia in susceptible plants within hours of application.
Ammonia is produced by plants as a result of normal metabolic processes.
- The glufosinate-ammonium tolerance gene engineered into corn line 1507
codes for the enzyme phosphinothricin acetyltransferase (PAT). This enzyme
detoxifies phosphinothricin by acetylation into an inactive compound. PAT has
extremely high substrate specificity and data included in the submission
indicates that it does not acetylate other enzymes or proteins.
- The pat gene was originally isolated from Streptomyces
viridochromogenes, an aerobic soil actinomycete bacterium. The PAT enzyme
is therefore naturally occurring in the soil. More generally, acetyltransferase
enzymes are ubiquitous in nature.
- The pat gene is linked to a constitutive promoter. The expression
of the pat gene in hybrid line 1507 was evaluated in leaf, pollen,
silk, stalk and grain. For all tissue samples taken in Canada, Chile and the
US, the levels of PAT protein were below the limit of detection. The LOD is 7.5
pg/µg total protein for samples tested from Canada, and 20 pg/µg
total protein for samples from the other locations. The PAT levels in Europe
were all below the LOD except for in leaf which had a mean PAT expression level
of 42 pg/µg total protein (LOD is 20 pg/µg total protein).
- Studies showed that the enzyme was digested within 5 seconds when subjected
to typical mammalian stomach conditions.
- The enzyme amino acid sequences for the PAT protein was provided in the
submission. The amino acid sequence showed no significant homology to toxins in
the Genbank database or allergens (based on sequence identity of 8 or more
contiguous amino acids) from standard DNA and protein sequence databases.
- The pat gene was expressed experimentally in a bacterial
expression system and the resulting enzyme was used to evaluate its
enzyme kinetics, to perform toxicology studies and as a standard in the
determination of protein expression from the modified plant. The inserted plant
expressed pat gene codes for a 22 kDa protein which was compared to
the bacterial produced protein and shown to be of similar molecular weight and
immunological reactivity. Peptide mass fingerprinting by matrix assisted laser
desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) was used
to determine the sequence equivalency of the two proteins.
- Southern blot analysis of different generations derived from line 1507
indicated that there is one site of integration of the introduced DNA which
includes a single copy of both of the inserted genetic elements in addition to
a short, non-coding fragment of the cry1F element.
- The backcross data is consistent with that of a single locus behaving in a
Mendelian hereditary fashion. Mendelian segregation data provides evidence of
the stable inheritance of the genetic elements introduced into corn line 1507.
Segregation analysis was performed on two stages in the breeding process,
designated as the F1 generation and the BC2F1 generation. Southern blot
analysis and determination of frequency of glufosinate-ammonium herbicide
tolerance and ECB resistance in progeny demonstrated that the traits were
inherited in a stable manner.
- The biology of corn, described in Dir94-11, shows that unmodified plants of
this species are not invasive of unmanaged habitats in Canada. Corn does not
possess the potential to become weedy due to traits such as lack of seed
dormancy, the non-shattering nature of corn cobs, and poor competitive ability
of seedlings. According to the information provided by Dow AgroSciences and
Pioneer Hi-Bred, corn line 1507 and derived hybrids were determined not to be
significantly different from their counterparts in this respect.
- CFIA evaluated data submitted by Dow AgroSciences and Pioneer Hi-Bred on
the reproductive and survival biology of corn hybrids derived from line 1507,
and determined that flowering period, vegetative vigour, time to maturity and
seed production were within the normal range of expression of these traits
currently displayed by commercial corn hybrids.
- No competitive advantage was conferred to these plants, other than that
conferred by resistance to the target pests and tolerance to
glufosinate-ammonium herbicide. These traits were demonstrated not to render
corn weedy or invasive of natural habitats since none of the reproductive or
growth characteristics were modified.
The above considerations, together with the fact that the novel traits have
no demonstrable effects on weediness or invasiveness, led the CFIA to conclude
that corn line 1507 has no altered weed or invasiveness potential compared to
currently commercialized corn.
- The biology of corn, as described in Dir94-11, indicates that there are no
wild relatives in Canada that can hybridize with corn. None of data submitted
by Dow AgroSciences and Pioneer Hi-Bred indicated any changes in sexual
compatibility as a result of the gene insertions.
CFIA therefore concludes that gene flow from line 1507 to wild corn
relatives is not possible in Canada.
- The intended effects of both novel traits are unrelated to plant pest
potential, and corn itself is not a plant pest in Canada (Dir94-11). In
addition, agronomic characteristics of the modified corn hybrids were shown to
be within the range of values displayed by currently commercialized corn
hybrids, and indicate that the growing habit of corn was not inadvertently
altered. Field observations did not indicate modifications to disease and pest
susceptibilities, other than to ECB and other lepidopteran pests of corn which
are not known to be limiting factors in the establishment and spread of corn in
Canada.
- Some of the genetic elements introduced into corn line 1507 were derived
from known plant pathogens, but in all cases the genes responsible for the
pathogenic qualities of the pathogen were not introduced. Therefore, the
introduction of genetic material for lepidopteran resistance and herbicide
tolerance would not be expected to result in corn line 1507 expressing novel
plant pathogen characteristics.
Based on these points, the CFIA has determined that line 1507 does not
display any altered plant pest potential.
- The history of use and available literature indicate that, with the
exception of certain insect pests, bacterial B.t. ð-endotoxins are not
toxic to humans, other vertebrates and non-lepidopteran invertebrates.
- The B.t. protein produced in line 1507 corn was shown to be equivalent to
the original bacterial protein. This protein is active only against specific
lepidopteran insects; no lepidopteran species which are listed as threatened or
endangered species in Canada will have significant exposure to the Cry1F
protein produced by widespread cultivation of corn line 1507.
- In addition, Dow AgroSciences and Pioneer Hi-Bred have submitted data from
dietary toxicity studies on the effect of the microbial Bt protein on
non-target organisms, including lepidoptera (monarch butterfly larvae),
pollinators (honeybees), predaceous insects (green lacewing larvae, ladybird
beetles), fresh water invertebrates (daphnia), soil insects (collembola) and
beneficial insects (parasitic hymenoptera). Dietary toxicity studies were also
conducted with earthworm and bobwhite quail. In addition, an acute oral gavage
study was used to test the toxicity of Cry1F to mice.
- Studies submitted by Dow AgroSciences and Pioneer Hi-Bred demonstrated that
the Cry1F protein expressed by corn line 1507 exhibits virtually no toxicity to
larvae of the monarch butterfly at levels as high as 10 mg toxin/ml diet, a
level which greatly exceeds anticipated environmental exposure, based on field
trial data.
- Corn is not known for the production of significant levels of endogenous
toxins and the transformation event that produced line 1507 would not be
expected to induce their synthesis. Additionally, corn line 1507 was
demonstrated not to be toxic to non-target organisms indicating that the
insertion of genetic elements did not result in unexpected toxicity. Corn is
however, known to produce low levels of trypsin inhibitor and phytic acid and
the levels of these compounds in line 1507 were found to be equivalent to
levels found in the control lines. The genetic modification, therefore did not
alter the expression of endogenous toxins.
Based on the above, the CFIA has determined that the unconfined release of
line 1507, when compared with currently commercialized corn, will not result in
altered impacts on non-target organisms.
- Corn line 1507 has no novel phenotypic characteristics that would extend
its use beyond the current geographic range of corn production in Canada. Since
there are no wild relatives of corn in Canada, there will be no transfer of
novel traits to unmanaged environments.
- With the exception of certain lepidopteran pest species, corn line 1507 has
been demonstrated to be safe for non-target organisms. The control of
agricultural pest species is a common practice in Canada that is not restricted
to the environmental release of PNTs, therefore the reduction in local pest
species as a result of the release of corn line 1507 does not present a
significant change from existing agricultural practices.
- The use of broad spectrum herbicides has the intended effect of reducing
local weed populations within agricultural fields and this may reduce local
weed species biodiversity, and possibly other trophic levels which utilize
these weed species. It must be noted however that reduction in weed
biodiversity in agricultural fields is not unique to the use of herbicide
tolerant crops, and is a common factor in virtually all modern agricultural
systems.
The CFIA has therefore concluded that the potential impact on biodiversity
of corn line 1507 does not present a significantly altered impact in comparison
to corn varieties currently being grown in Canada.
- The following IRM design is intended to reduce or delay European corn borer
resistance to the Cry1F protein. Corn line 1507 also targets corn earworm,
black cutworm and fall armyworm, however no modification is required to the
present IRM design to address resistance in these pests since there are no
significant overwintering populations of these insects in Canada.
- Lepidopteran insects have a significant ability to develop resistance to
conventional chemical insecticides, therefore it is reasonable to expect that
resistance to the insecticidal properties of corn line 1507 may develop. B.
thuringiensis var aizawai preparations are commercially available
for control of various lepidopteran pests and the development of resistance to
Cry1F due to the environmental release of corn line 1507 may result in the
reduction or loss of efficacy of the foliar spray Bt products. Corn line 1507
produces Cry1F throughout the growing season therefore target insects will be
exposed to significantly higher levels of Cry1F than through the current foliar
spray treatments, leading to high selection pressures for resistant ECB
individuals.
- In order to significantly minimize the likelihood of the development of
insect pest resistance to PNTs expressing novel insect resistance, the CFIA
requires that an insect resistance management (IRM) plan be implemented for
these products. A component of the IRM strategy that will be used with corn
line 1507, is the establishment of structured refugia (unmodified corn)
arranged in strip rows or blocks within or near the insect pest resistant corn
field. Should resistant insects occur, they would then be able to mate with
susceptible insects to keep the frequency of resistance genes diluted in the
insect population.
CFIA believes that sound management practices and IRM strategies can
significantly reduce and delay the development of Cry1F resistant ECB
populations, however the ECB populations must be monitored for the development
of resistance in a regular and consistent manner. CFIA understands that Dow
AgroSciences and Pioneer Hi-Bred have developed and will implement an insect
resistance management plan that includes the following key components:
(i) The use of structured refugia to provide a population of insects
that have not been exposed to the Cry1F protein and are available to reproduce
with potentially resistant insects that may emerge from the Bt crop.
(ii) The early detection of insect populations resistant to the
corn-expressed insecticidal protein is extremely important. Close monitoring
for the presence of such populations, in insect-resistant corn fields and
surrounding areas, is therefore warranted. Monitoring includes the development
of appropriate detection tools such as visual field observations and laboratory
bioassays, education of growers, reporting schedules, and enforcement
procedures in case of resistance development.
(iii) Education tools will be developed and provided to all growers,
district managers and field managers. These will include information on product
performance, resistance management, monitoring procedures and timetables,
detection protocols for resistant individuals, instructions to contact Dow
AgroSciences and Pioneer Hi-Bred, and strategies to be followed if unexpected
levels of lepidopteran pest damage occur.
(iv) Dow AgroSciences and Pioneer Hi-Bred will have procedures in
place for responding to these reported instances of unexpected target pest
damage. These procedures will include, where warranted, the collection of plant
tissue and pest insects and use of appropriate bioassays to evaluate suspected
Cry1F resistant individuals, and a protocol for immediate action to control
resistant individuals.
(v) Detection of confirmed resistant lepidopteran pest populations and
subsequent action plan will immediately be reported to CFIA.
(vi) Integrated Pest Management practices will be promoted, such as
prediction of infestation problems from previous years and crop rotation.
Note: The Plant Biosafety Office periodically audits compliance with the IRM
requirements.
If there is general adoption of several different crop species with novel
herbicide tolerances, then the potential exists for the development of crop
volunteers with a combination of tolerances to different herbicides. Therefore,
this technology should be managed as part of an integrated approach which may
include currently available weed control products with alternate modes of
action, or alternative methods of weed control. Of additional note is the use
several crop species in rotation which all rely on tolerance to the same
herbicide. Another potential concern is that the continued use of a specific
herbicide may provide significant selective pressure for the potential
development of herbicide tolerant weeds. Therefore, agricultural extension
personnel in both the private and public sectors should promote careful
management practices for growers who use these herbicide-tolerant crops to
minimize the development of multiple herbicide tolerant crop volunteers as well
as tolerant weed populations. The CFIA is currently working with the Pest
Management Regulatory Agency of Health Canada to develop strategies which
address the issues of multiple herbicide tolerant volunteers and herbicide
tolerant weeds in a broad industry led stewardship program.
Nutritional Composition of Corn Line 1507
Composition of grain and whole plant from Line 1507 was compared with an
unmodified control corn line with the same genetic background. Data were
obtained from trials conducted in four locations in Chile, with sufficient
replication to allow for statistical analysis. Whole plant analysis included
proximates, acid digestible fibre (ADF) and neutral digestible fibre (NDF).
Grain analysis included proximates, major fatty acids, amino acids,
tocopherols, B vitamins and minerals. Slight but statistically significant
differences in ADF in whole plant were reported. No other differences in whole
plant were observed. In grain, there was significantly lower fat, lower
manganese and higher potassium in line 1507 compared to the control. These
differences were not of significant nutritional consequence, and were likely
due to normal variability. There were no other differences between Line 1507
and control grain. All nutrients measured were within the normal range for
corn. Additional supporting data from agronomic trials of Line 1507 grown in
Ontario was submitted. A study conducted in Italy and France on the nutrient
composition in grain and forage of line 1507 and Mycogen Inc. brand hybrid 2722
(a corn variety with similar genetic background as line 1507), showed no
difference in proximate analysis for both grain and forage between the two corn
lines. The CFIA therefore concludes that line 1507 has equivalent nutritional
composition to commercial current corn.
- Corn is not known for the production of endogenous allergens and the
transformation event which produced line 1507 would not be expected to induce
their synthesis. Additionally, the non-target toxicity studies did not
demonstrate any unexpected toxicity of corn line 1507.
- The history of use and literature suggest that the bacterial B.t.
ð-endotoxin is not toxic to humans and other vertebrates. The B.t. protein
produced in corn was shown to be equivalent to the original microbial
protein.
- A mouse acute oral toxicity test and a bobwhite quail dietary toxicity
study using Cry1F protein were conducted. No adverse effects were
demonstrated.
- A mouse acute oral toxicity test was performed using PAT protein. No
adverse effects were demonstrated.
Based on the expected exposure levels and the results of the above tests,
the CFIA concludes that there is not expected to be any significant risk to
livestock from dietary exposure to the Cry1F and PAT proteins in livestock
feed.
If at any time, Dow AgroSciences and Pioneer Hi-Bred become aware of any
information regarding risk to the environment, including the development of
lepidopteran pest resistance, or risk to human or animal health that could
result from release of these materials in Canada, or elsewhere, Dow
AgroSciences and Pioneer Hi-Bred will immediately provide such information to
the CFIA. On the basis of such new information, the CFIA will re-evaluate the
potential impact of the proposed feed use and environmental release and will
re-evaluate its decision with respect to the livestock feed use and
environmental release authorizations of this corn line.
Based on the review of data and information submitted by Dow AgroSciences
and Pioneer Hi-Bred, and through comparisons of corn line 1507 with unmodified
corn counterparts, the Plant Biosafety Office, CFIA, has concluded that the
novel genes and their corresponding traits do not confer to these plants any
characteristic that would result in intended or unintended significant
environmental effects following unconfined release. Dow AgroSciences and
Pioneer Hi-Bred have developed and will implement a resistance management
plan.
Based on the review of submitted data and information by Dow AgroSciences
and Pioneer Hi-Bred, including comparisons of corn line 1507 with unmodified
corn counterparts, the Feed Section, CFIA, has concluded that the modified gene
and its corresponding novel trait will not confer to these plants any
characteristic that would raise any concerns regarding the safety or
nutritional composition of corn line 1507 for livestock animals. Grain corn,
its byproducts and corn oil are currently listed in Schedule IV of the Feeds
Regulations and are, therefore approved for use in livestock feeds in Canada.
Corn line 1507 has been assessed and found to be substantially equivalent to
traditional corn varieties, with respect to safety and nutritional quality.
Corn line 1507 and its products are considered to meet present ingredient
definitions and are approved for use as livestock feed ingredients in
Canada.
Unconfined release into the environment and livestock feed use of
the corn line 1507 is therefore authorized as of October 10, 2002. Any other
corn lines and intraspecific hybrids resulting from the same transformation
event, and all of their descendants, are also approved, provided no
inter-specific crosses are performed, provided the intended use is similar,
provided it is known following thorough characterization that these plants do
not display any additional novel traits and are substantially equivalent to
currently grown corn, in terms of their potential environmental impact and
livestock feed safety and provided that pest resistance management requirements
described in the present document are applied.
The corn line 1507 is subject to the same phytosanitary import
requirements as its unmodified counterparts
Please refer to Health Canadas Decisions on Novel Foods for a
description of the food safety assessment of corn line 1507. The food safety
decisions are available at the following Health Canada web site:
http://www.hc-sc.gc.ca/food-aliment/mh-dm/ofb-bba/nfi-ani/e_novel_foods_and_ingredient.html
This bulletin is published by the Plant Health and Production Division,
Canadian Food Inspection Agency. For further information, please contact the
Plant Biosafety Office or the Feed Section at:
Plant Biosafety Office
Plant Health and Production Division
Plant Products Directorate
59 Camelot Drive, Nepean
Ontario K1A 0Y9
Tel: (613) 225-2342
Fax: (613) 228-6614 |
Feed Section
Animal Health and Production Division
Animal Products Directorate
59 Camelot Drive, Nepean
Ontario, K1A 0Y9
Tel: (613) 225-2342
Fax: (613) 228-6614
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