Food safety and quality
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OECD Unique Identifier details

53Ø7
Commodity: Corn / Maize
Traits: Coleoptera resistance
Philippines
Name of product applicant: Syngenta Philippines
Summary of application:

On April 17 2012, Syngenta Philippines submitted an application to the Bureau of Plant Industry requesting for biosafety permit under Administrative Order (AO) No. 8 Part 5 for Corn 5307 which has been genetically modified for insect resistance.


Syngenta Philippines Inc. has provided data on the identity of corn 5307, a detailed description of the modification method, data and information on the gene insertion sites, copy numbers and levels of expression in the plant, the role of the inserted genes and regulatory sequences in donor organisms, and full nucleotide sequences. The novel proteins were identified, characterized, and compared to the original bacterial proteins, including an evaluation of their potential toxicity to livestock. Relevant scientific publications were also supplied.


The petitioner/applicant published the said application on two widely circulated newspapers: Manila Standard Today and The Manila Times on August 3, 2012 for public comment/review. During the 30- day comment period, BPI had not received comment on the said application.

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Date of authorization: 11/06/2015
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
Corn 5307 has been evaluated according to BPI’s safety assessment by concerned agencies [Bureau of Animal Industry (BAI), Bureau of Agriculture and Fisheries Standards (BAFS) and a Scientific and Technical Review Panel (STRP)]. The process involves an intensive analysis of the nature of the genetic modification together with the consideration of safety assessment paradigm, which includes molecular characterization, protein characterization, and food/feed composition. The species-specific insecticidal mode of action of eCry3.1Ab and its similarity to other Cry proteins for which human safety has previously been established (e.g., mCry3A, Cry3A, and Cry1Ab) support the prediction that no adverse health effects will result from exposure to the eCry3.1Ab protein present in corn 5307. No toxicity to mammals was observed following oral exposure to high doses of eCry3.1Ab, and the properties of this protein do not indicate allergenic potential. The eCry3.1Ab protein does not share significant amino acid sequence similarity to known protein toxins and no adverse test-substancerelated effects were observed in mice administered a single high dose (2000 mg/kg body weight) of eCry3.1Ab protein. Therefore, eCry3.1Ab is considered nontoxic. Bioinformatic analyses also demonstrated that the PMI amino acid sequence (391 amino acids) has no significant sequence similarity to any toxins. This comparison was conducted using a 2010 posting of the National Center for Biotechnology Information (NCBI) Entrez® Protein Database (NCBI 2010b), and searching the database using the Basic Local Alignment Search Tool for Proteins (BLASTP) program. Analysis of key nutritional components of forage and grain from corn 5307 showed that no biologically significant changes in composition occurred as an unintended result of the transformation process or expression of the transgenes in corn 5307. Forage and grain from corn 5307 are considered similar in composition to forage and grain from conventional corn. In addition, a 49-day feeding study demonstrated that there were no adverse dietary effects on broiler chickens consuming diets prepared with corn 5307 grain when compared with those consuming diets prepared with non-transgenic, control corn grain, either as a direct effect of the transgenic proteins in the diet or as a result of any unintended compositional changes in the grain that may have altered its nutritional value. These results support the conclusion that corn 5307 is nutritionally comparable to and as safe as conventional corn. Corn 5307 is not intended to change the nutritional status of individuals/ populations/ livestock or to result in products with enhanced functionality. Compositional analysis and whole food and safety tests have demonstrated that no unexpected alterations in nutrients and other food components have occurred and that no nutritional imbalances were introduced.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Ma. Lorelie U. Agbagala
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 404 0409 loc 202
Fax number:
Country introduction:

In 1987, scientists from the University of the Philippines Los Banos (UPLB) and the International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI), and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD), recognizing the potential harm of the introduction of exotic species and genetic engineering, formed a committee and formulated the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. The committee went on to draft a Philippine biosafety policy, which was submitted to the Office of the President. On October 15, 1990, recognizing the potential for modern biotechnology both in improving the lives of the people and in creating hazards if not handled properly, President Corazon C. Aquino issued Executive Order 430 creating the National Committee on Biosafety of the Philippines (NCBP) that will formulate, review and amend national policy on biosafety and formulate guidelines on the conduct of activities on genetic engineering. The NCBP is comprised of representative of the Departments of Agriculture (DA); Environment and Natural Resources (DENR); Health (DOH); and Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science; and 2 respected members of the community. On July 16, 2001, President Gloria Macapagal-Arroyo issued the Policy Statement on Modern Biotechnology, reiterating the government policy on promoting the safe and responsible use of modern biotechnology. On April 3, 2002, Department of Agriculture Administrative Order No. 8, Series of 2002 was issued implementing the guidelines for importation and release into the environment of Plants and Plant Products Derived from the Use of Modern Biotechnology. On March 17, 2006, President Gloria Macapagal-Arroyo issued Executive Order No.514 Establishing the National Biosafety Framework, prescribing guidelines for its implementation, reorganizing the National Committee on Biosafety of the Philippines, and for other purposes. On December 8, 2015, the Philippine Supreme Court declared DA AO8 null and void and any application for contained use, field testing, propagation and commercialization, and importation of GMOs was temporarily enjoined. In response to the nullification of DA AO8, the Technical Working Group composed of representatives from the Departments of Agriculture (DA), Science and Technology (DOST), Environment and Natural Resources (DENR), Health (DOH), and Interior and Local Government (DILG) drafted the Joint Department Circular No. 1, Series of 2016 (JDC No.1, S2016) titled 'Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically-Modified Plant and Plant Products Derived from the Use of Modern Biotechnology'. There were series of meeting and five public consultations conducted before the JDC No.1, S2016 was approved and signed by the Secretaries of the abovementioned agencies on March 7, 2016 and took effect on April 15, 2016. Under this Circular, more government agencies were involved such as the Department of Science and Technology (DOST) to regulate applications for contained use and confined test of regulated articles; Department of Agriculture (DA) to evaluate applications for field trial, commercial propagation and transboundary movement of regulated articles; Department of Environment and Natural Resources (DENR) to evaluate environmental risks and impacts of regulated articles; Department of Health (DOH) to evaluate of environmental health impacts of regulated articles; and Department of the Interior and Local Government (DILG) to supervise public consultation during field trial.

 

Useful links
Relevant documents
Stacked events:

Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004