Determination of the Safety of BASF’s
BPS-CV127-9 Soybean (Herbicide Tolerant)
For Direct Use as Food or Feed or for Processing
Food and Feed Safety
The product dossier BPS-CV127-9 Soybean was reviewed for safety and nutritional differences
compared with the conventional soybean. The review was focused on any new or altered
expression trait and changes in composition and nutritional content or value relative to the
conventional soybean. After thorough evaluation on the safety assessment, the following
conclusions were made: BPS-CV127-9 Soybean is as safe as its conventional counterpart taking
into its dietary source and nutritional impact of any changes in nutritional value. CV127
soybean is safe to humans, animals and as nutritious as conventional soybean.
A biosafety permit for soybean CV127-9 and all progenies derived from crosses of the product
with any conventionally soybean containing approved-biotech events for direct use was issued
to BASF Philippines, Inc. on October 29, 2010. The validity of the permit was only five years.
This approval is for use as food and feed or for processing of soybean CV127-9 in the Philippines.
Food and feed use of soybean CV127-9 and its by-products is therefore authorized as of Oct 29,
2010. The biosafety permit (No. 10-051) for direct use stated that “soybean CV127-9 and all
progenies from crosses of this product except when stacked with other biotech traits has
undergone satisfactory assessment and found to be as safe as conventional soybean and can be a
substitute for its traditional counterpart as food and feed or for processing”
I.
Brief Identification of the Genetically Modified Organism (Living Modified
Organism)
Designation:
BPS-CV127-9
Applicant:
BASF Philippines, Inc.
11/F Hanjinphil Corporation Building
1128 University Parkway
North Bonifacio, Global City, Taguig, Metro
Manila, Philippines
Plant Species:
Corn
:
Soybean (Glycine max.)
Parent Material :
Imidazolinone-tolerant soybean developed by
Plant Science (BPS)
Center of Origin:
Brazil and Argentina
Toxic Factors/Allergen(s): Trypsin inhibitors, lectins, urease,
stachyose, raffinose and phytic acid.
Trait Description:
Imidazolinone
herbicide
tolerance/weed resistance)
Trait Introduction Method: Biolistics method
BASF
phytoestrogens,
tolerant
(herbicide
Donor Organism:
Arabidopsis thaliana, source of gene csr1-2 with its native
promoter which is a small flowering plant that is widely
used as a model organism in plant biology.
Pathogenicity:
Arabidopis thaliana, the donor organism of csr1-2, is not a
known human or animal pathogen and is not known to
cause allergic reactions in humans. There is no evidence
that A.t. is pathogenic to humans and it is not known to
produce toxins or allergens.
Proposed Use:
For direct use as food, feed and for processing
II. Background Information
BASF Philippines, Inc. has developed a new genetically modified soybean that is tolerant
to the imidazolinone class of herbicides. The imidazolinone herbicides control a wide
spectrum of grass and broadleaf weeds and possess high biological efficacy at low
application rates. The herbicide tolerant BPS-CV127 soybean (also referred to as
CV127) are derived from a single transformation event and was developed to address
weed control challenges to soybean growers. Introduction of CV127 soybean varieties
will offer soybean growers an additional tool for controlling problem weeds as well as
an important option for weed resistance management.
The imidazolinone-tolerant
soybean exhibits similar herbicide tolerance properties as various imidazolinonetolerant crops produced.
On July 8, 2010, BASF Philippines, Inc. submitted an application to the Bureau of Plant
Industry requesting for biosafety permit under A.O. #8 for soybean which has been
genetically modified for weed resistance.
BASF Philippines, Inc. has provided information on the safe history of use of the crop,
the source of the donor gene, the molecular characterization of CV127 soybean, the
stability of the inserted genetic elements, characterization and expression levels of
AHAS proteins produced in the CV127 soybean plant, lack of any allergenicity or toxicity
characteristics associated with AHAS protein and CV127 soybean, as well as the nutrient
composition of the soybean grain, forage and grain processed fractions, and overall food
and feed safety of CV127 soybean plants. Relevant scientific publications were also
supplied.
CV127-9 Soybean has been evaluated according to BPI‘s safety assessment by concerned
agencies: Bureau of Animal Industry (BAI), Bureau of Plant Industry (BPI), Bureau of
Agriculture Fisheries and Product Standards (BAFPS) and a Scientific Technical Review
Panel (STRP). The process involved an intensive analysis of the nature of the genetic
modification with a consideration of general safety issues, toxicological, nutritional and
environmental issues associated with the modified soybeans.
The petitioner/applicant published the said application on two (2) widely circulated
newspapers (Malaya Business Insight and The Daily Tribune) on May 20, 2010 for
public comment/review. BPI received positive comments on the petition supporting the
application for direct use as food and feed or for processing of CV127-9 Soybean during
the 30-day comment period.
Review of results of evaluation by the BPI Biotech Core Team completed the approval
process.
III.
Description of Novel Protein (Introduced Traits)
The csr1-2 gene that has been inserted into the genome of soybean CV127 is derived
from Arabidopsis thaliana which is a member of the mustard (Brassicaceae) family,
which includes cultivated species such as cabbage and radish. Arabidopis thaliana is a
small flowering plant which is widely used as a model organism in plant biology.
CV127 soybeans were produced by introduction of the iminidazolinone-tolerant
acetohydroxyacid synthase large subunit gene csr1-2 from Arabidopsis thaliana into the
soybean plant genome. The csr1-2 encodes an acetohydroxyacid synthase large subunit
(AHASL) protein that is tolerant to imidazolinone herbicide due to a single nucleotide
mutation that results in a single amino acid substitution in which the seine residue at
position 653 of the protein is known to prevent the binding of imidazolinone herbicides
and thereby to result in tolerance to these herbicides.
Safety of the Expressed Proteins
Arabidopsis thaliana has been cultivated widely as a model plant for genetic and
biochemical research without any associated safety concerns and the plant is closely
related to plant species in the mustard family that have a history of safe human
consumption.
The csr1-2 gene encodes the AtAHAS protein that confers tolerance to the imidazolinone
herbicides. Biochemical characterization of the AtAHAS protein expressed in CV127
soybean showed that the AtAHAS protein is homologous to other AHAS proteins present
in crop plants and has characteristics typical of most dietary proteins with a history of
safe use in food and feed products and lacks any characteristics associated with known
toxic or allergenic proteins.
The Arabidopsis AHASL (AtAHAS) is a member of the class of AHAS proteins found
ubiquitously in plants. The AHASL enzyme catalyzes the first step in the biosynthesis of
branched-chain amino acids, valine, leucine, and isoleucine. The herbicide tolerance in
CV127 soybean will allow growers to treat the soybean crop with imidazolinone
herbicides for weed control without causing injury to the soybean plant at normal field
application rates.
The safety of the AtAHAS protein for human consumption was assessed by several
different approaches. Bioinformatic searches of databases of all known proteins,
including protein toxins as well as of known allergenic proteins were conducted and it
was confirmed that the AtAHAS protein expressed in CV127 soybean does not share
immunologically relevant amino acid sequence segments or structure with known
allergens or have sequence homology to known protein toxins.
Therefore, the AtAHAS protein expressed in CV127 soybean tissues does not pose any
attributed known protein food allergens, is not toxic to mammals, and therefore
presents no risks for human or animal consumption
IV.
Nutritional Composition (Compositional Analysis)
Studies demonstrated that the mean and range values for proximate analyses for
moisture, ash, protein , crude fat, dietary fiber, carbohydrate and calorie content, amino
acids, fatty acids and minerals (potassium, magnesium, calcium, iron and phosphorus);
vitamins (trocopherols) showed comparable ranges with commercial soybean.
The nutritional equivalence of CV127 soybean to conventional soybean was confirmed
in several feeding studies with broiler chickens and birds. The studies showed that
CV127-9 and the commercial variety are substantially equivalent in comparison.
Thus CV127-9 can be used in food and feed formulations and 100% substitute for
commercial soybean.
V.
Anti-Nutritional Factors
Although soybean does not produce any known toxic compounds, it does contain
antinutrients with very low amount and are below the thresholds considered to raise a
food safety concern. These include trypsin inhibitors, lectins, urease, phytoestrogens,
stachyose, raffinose and phytic acid. However, the amount of anti-nutrients present in
CV127 soybean fell within the range found in conventional standard varieties.
VI.
Regulatory Decision
After viewing the scientific data and information relevant to the application of BASF
Philippines, Inc. it is concluded that CV127-9 Soybean and all progenies from crosses of
this product except when stacked with other biotech traits for direct use is as safe and
substantially equivalent to its unmodified counterpart and is therefore approved for
direct use as food, feed and for processing.
BASF shall duly inform the public of this approval by the way of publishing in any one
(1) of the top three (3) leading newspapers in the country that imports of this product is
covered by conditions for approval as provided in Department of Agriculture
Memorandum Circular No. 8, Series of 2003.
.