Biotechnology Situation and Outlook

An Expert's View about Fiber Crops in the Philippines

Last updated: 29 Sep 2011

The Philippine biotechnology regulatory system remains science-based and the country is increasingly being looked up to for guidance on biotechnology policy and regulations by other developing countries.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 8/16/2011 GAIN Report Number: Philippines Agricultural Biotechnology Annual Philippine Biotechnology Situation and Outlook Approved By: William Verzani Prepared By: Perfecto G. Corpuz Report Highlights: The Philippine biotechnology regulatory system remains science-based and the country is increasingly being looked up to for guidance on biotechnology policy and regulations by other developing countries. Commercialization of the first locally developed genetically enhanced crop (Bt eggplant) will likely take place by early 2013, and Golden Rice is likely to follow shortly there after. There have been no reported biotechnology related trade disruptions, and U.S. exports of GE products continued to grow in 2010. Philippine agricultural policy remains food security oriented and policy developments have been positive. However, in the recently approved Philippine Development Plan, there are provisions that support the labeling of foods derived from GE products, as well as a precautionary approach to environmental risk assessments. Section I. Executive Summary: The Philippine biotechnology regulatory system continues to evolve but remains science-based. Under the current regulatory regime as provided for by the Philippine Department of Agriculture?s Administrative Order No. 8 (DA-AO 8), 32 transformation events (TEs) and 27 stacked-trait products have been approved for direct use as food, feed or for propagation. There are eight (8) biotech crop varieties approved for propagation while 13 field tests have been allowed since 2004. Guided by DA- AO 8, the first genetically enhanced (GE) crop being developed locally, the Fruit and Shoot Borer (FSBR) Resistant or Bacillus thuringiensis (Bt) eggplant, will likely be commercialized by early 2013. The commercial release of Golden Rice is expected to follow shortly there after. The adoption of GE corn, the only GE crop currently approved for cultivation in the Philippines, has been phenomenal. Since 2003, the area devoted to GE corn has increased 50-fold. In 2010, despite overall corn area declining from the previous year?s level as a result of an El Nino weather disturbance, area cultivated with GE corn still increased. GE corn in 2010 comprised 22 percent of overall Philippine corn area and is poised to again increase in 2011, weather permitting. The dramatic increase in adoption rate of GE corn seed use is a testament to the benefits it brings to local corn farmers, in addition to its positive contribution to the economy and the environment. U.S. agricultural exports to the Philippines with possible derivation from modern agricultural biotechnology continued to grow in 2010. From 2003-2010, U.S. exports increased more than 245 percent from $142 million to $492 million. Soybean-based products accounted for the majority share (73 percent) of exports in 2010 while sweeteners posted the greatest increase (693 percent) from the 2003 level. In 2010, U.S. exports of soybean meal, feeds and fodders, sweeteners and vegetable oil all reached their highest export levels since at least 1970. The country continues to be a regional leader in biotechnology and other developing countries are increasingly looking to the Philippines for guidance on biotechnology policy and regulations. Despite the gains realized since its introduction in 2003, there are still isolated pockets of resistance to modern agricultural biotechnology in the Philippines. In the recently approved 2011-2016 Philippine Development Plan, there are also provisions that support the labeling of foods derived from GE products, as well as a precautionary approach to environmental risk assessments. Section II. Plant Biotechnology Trade and Production: As of July 2011, there were eight (8) GE crop varieties approved for commercial production. This consisted of five (5) TEs and three (3) stacked or combined trait products (refer to Annex II and Annex II-A, respectively). All the GE crop varieties approved for propagation were corn. Since 2003, when the first GE corn crop was planted, the area devoted to GE corn has increased 50-fold through 2010. In 2010, the Philippine Bureau of Plant Industry (BPI) estimated the total area planted with GE corn at 543 thousand hectares, a significant 66 percent increase from the 327 thousand hectares planted in 2009. About 75 percent of all GE corn planted in 2010 was located in the main island of Luzon. Stacked trait GE corn comprised over 90 percent of all Philippine GE corn planted during the year. It is noteworthy that while GE corn area in 2010 increased from the previous year?s level, the area devoted to overall corn production declined from the 2009 level due to an El Nino-induced drought. According to the January 2011 Rice and Corn Situation and Outlook of the Philippine Bureau of Agricultural Statistics, the aggregate corn area harvested in 2010 was 2.5 million hectares or 7 percent below the 2.7 million hectares of area recorded in 2009. In 2010, GE corn accounted for roughly 22 percent or over a 5th of all Philippine corn areas, compared to the 13 percent share during the previous year. For 2011, continued rains are again likely to encourage more corn production and an increase in share of GE corn seed. The following is a table on GE corn area from 2003 to 2010. AGGREGATE DATA OF GE CORN PLANTED 2003-2010 (hectares) 2003 2004 2005 2006 2007 2008 2009 2010 Bt Corn LUZON 10,158 48,516 43,735 85,702 103,438 68,301 38,507 37,115 VISAYAS 24 534 445 405 2,551 298 0 0 MINDANAO 587 10,706 5,829 10,693 16,604 13,053 9,516 3,120 Total 10,769 59,756 50,009 96,800 122,593 81,652 48,023 40,235 RR Corn LUZON 11,685 54,509 5,471 3,518 642 VISAYAS 4,424 8,925 4,571 2,790 0 MINDANAO 10,384 56,589 41,443 40,501 8,048 Total 26,493 120,023 51,485 46,809 8,690 Stacked (Bt + RR) LUZON 3,879 59,346 158,520 183,771 373,079 VISAYAS 232 2,472 7,074 8,006 5,366 MINDANAO 469 9,461 48,844 40,618 115,153 Total 4,580 71,279 214,438 232,395 493,598 GRAND TOTAL 10,769 59,756 50,009 127,873 313,895 347,575 327,226 542,522 *Bt ?Bacillus thuringiensis *RR ? Roundup Ready Source of Data: Bureau of Plant Industry The dramatic adoption of GE corn in the Philippines mirrors the global trend in overall GE crop adoption. In its 2010 annual report, the International Service for the Acquisition of Agri-biotech Applications (ISAAA) noted that GE crops were planted in 148 million hectares by an estimated 15.4 million farmers from 29 countries. The accumulated area since the first GE crop was planted in 1996 exceeded 1 billion hectares in 2010. The ISAAA report describes the dramatic growth as ?the fastest- adopted crop technology in the history of modern agriculture?. In the report, the Philippines ranked 13th among 209 countries (including several EU countries) with the largest GE crop planted area. Additionally, developing countries were expected to have the most increase in GE crop adoption in the near future. Highlights of the 2010 ISAAA report are provided in the following link: http://www.isaaa.org/resources/publications/briefs/42/executivesummary/default.asp A similar report entitled ?GM crops: global socio-economic and environmental impacts 1996-2009? by Graham Brookes, (director of UK-based PG Economics Ltd) and co-authored by Peter Barfoot, was released in April 2011. According to the report, biotech crops provided for less fuel use and an increase in no-till farming, thus leading to reduction of CO2 emission by 17.7 billion kg in 2009 (equal to removing 7.8 million cars from the road for one year). Also according to the report, GE crops have reduced pesticide spraying (1996-2009) by 393 million kg (-8.7%) and as a result, have decreased the environmental impact associated with herbicide and insecticide use on the area planted to biotech crops by 17.1 percent. Without biotechnology, the report notes, maintaining global production at the 2009 level would have needed plantings of an additional 3.8 million hectares of soybeans, 5.6 million hectares of corn, 2.6 million hectares of cotton and 0.3 million hectares of canola. The total area requirement would be about 7 percent of the arable land in the United States, or 24 percent of the arable land in Brazil. Excerpts from the Brookes and Barfoot report are provided in the following link: http://www.bsba.ag/BSBA/NewsBg/Entries/2011/4/13_GM_crops__global_socio- economic_and_environmental_impacts_1996-_2009.html The latest list of regulated articles approved for field testing in the Philippines is provided in the following table. As of July 2011, there were 13 GE crop field trials approved, (i.e., 11 corn and 2 papaya field tests), up from 11 recorded in the previous annual report. APPROVAL REGISTRY FOR FIELD TESTING OF REGULATED ARTICLES (As of July 6, 2011) Proposal Technology Developer Date Approved 1. Demonstration of Weed Control Performance of Roundup Ready Corn (RRC) Monsanto Philippines Nov. 26, System DK818 NK603 vis-a-vis Farmers? Practices 2004 2. Performance of Roundup Herbicide (360 g ae/L IPA Salt) Against Weeds in Monsanto Philippines Nov. 26, Glyphosate-Tolerant corn 2004 3. Field Verification of the Agronomic Performance of the Transgenic Corn (Zea mays Monsanto Philippines Dec. 10, L.) Hybrid Stacked (NK603/MON810) Expressing the Bacillus thuringiensis Cry1Ab 2004 Protein for Resistance against the Asiatic Corn Borer (Ostrinia furnacalis Guenee) and CP4EPSPS for Tolerance Against the Herbicide Roundup 4. Performance of Herculex 1 Bt Transgenic Corn Hybrids Against Asiatic Corn Borer Dow AgroSciences May 2, (Ostrinia furnacalis Guenee) Under Field Conditions in the Philippines 2006 5. Field Testing of Transgenic Papaya with Delayed Ripening Trait Institute of Plant Breeding - Mar. 20, Crop Science Cluster, UP, 2007 Los BaƱos, Laguna 6. Multi-location Field Efficacy Verification Trial of Herbicide Tolerant Maize Syngenta Philippines Nov. 19, Expressing Event GA21 Against Glyphosate Herbicide in the Philippines 2007 7. Agronomic Equivalency Trial of MON89034 Hybrids with Regulatory Framework in Monsanto Philippines Aug. 1, the Philippines 2008 8. Field Verification of the Agronomic Performance of Transgenic Corn (Zea mays L.) Monsanto Philippines Aug. 1, line MON89034 Expressing the Bacillus thuringiensis Cry1A.105 and Cry2Ab Proteins 2008 for Efficacy Against Lepidopterous Pest of Corn 9. Field Verification for the Agronomic Performance of Stacked Hybrid Corn (Zea Monsanto Philippines Aug. 1, mays L.) MON89034 x NK603 Expressing the Bacillus thuringiensis Cry1A.105 and 2008 Cry2Ab2 Proteins for Efficacy Against Lepidopterous Pests of Corn and CP4EPSPS for Tolerance of Round up Herbicide 10. Multi-location Field Efficacy Trial of Corn Hybrid Expressing the Stacked Trait Syngenta Philippines Oct. 28, BT11 x GA21 Against the Asiatic Corn Borer and Glyphosate Herbicide in the 2009 Philippines 11. Development and Commercialization of Philippine Fruit and Shoot Borer (FSB) University of the Philippines Mar. 16, Resistant Eggplants Containing MAHYCO Bt Eggplant Event, EE-1: Multi location Los Banos 2010 Field Trials for Biosafety Assessment, Variety Accreditation and Fertilizer and and Pesticide Authority (FPA) Registration June 28, 2010 12. Field Verification of the Agronomic Performance of Transgenic corn (Zea mays L.) Pioneer Hi-Bred Philippines April 19, Line TC1507 Expressing the Bacillus thuringiensis Proteins for Efficacy Against 2011 Asiatic Corn Borer and the PAT Proteins for tolerance to Glufosinate Herbicide 13. Field Verification of the Agronomic Performance of Transgenic Corn (Zea mays Pioneer Hi-Bred Philippines April 19, L.) Hybrid Stacked (TC1507 x MON810 x NK603) Expressing the Bacillus 2011 thuringiensis Proteins for Efficacy Against Asiatic Corn Borer and the Proteins PAT and CP4-EPSPS for Tolerance to Glufosinate and Glyphosate Herbicides Source of Data: Bureau of Plant Industry The multi-location trials of the FSBR eggplant (no. 11) by the University of the Philippines at Los Banos are expected to produce the first commercialized GE crop developed locally. According to industry contacts, FSBR eggplant should be commercially available by 2013. Commercialization would have been earlier had it not been for resistance and opposition due to the lack of public consultations and support as required by existing biotechnology rules. As mentioned in the previous annual report, the Golden Rice Project is under the supervision of the National Committee on Biosafety of the Philippines (NCBP) and, therefore, is not listed in the approval registry for field testing of regulated articles. According to contacts, the submission of the full application for its commercial planting may happen by 2013 or following the FSBR eggplant commercialization. The following table shows U.S. agricultural exports to the Philippines that possibly were derived from modern agricultural biotechnology from 2003-2010. U.S. exports to the Philippines increased more than 245 percent from $142 million to $492 million. Soybean-based products accounted for the majority share (73 percent) of exports in 2010 with sweeteners posting the greatest increase (272 percent) from the 2009 level. In 2010, U.S. exports of soybean meal, feeds and fodders, sweeteners and vegetable oil all reached their highest export levels since at least 1970. CY US Exports to the Philippines (In Thousand $) 2003-2010 % Change 2003 2004 2005 2006 2007 2008 2009 2010 03/10 09/10 Soybean Meal 56,658 75,049 119,829 123,329 189,872 243,909 317,075 325,917 475.24 2.79 Feeds & Fodders 9,224 13,690 17,899 33,265 41,715 53,026 50,376 72,286 683.67 43.49 Soybeans 41,872 51,831 48,042 25,525 26,814 26,297 24,761 30,261 -27.73 22.21 Sweeteners 10,071 7,400 5,431 9,842 11,492 15,751 11,287 41,950 316.54 271.67 Coarse Grains 148 214 14,179 192 776 802 3,922 842 468.92 -78.53 Cotton 21,073 32,080 19,836 13,295 11232 8,360 19,187 13,922 -33.93 -27.44 Vegetable Oil 3,071 3,733 3,347 3,506 4,694 4,756 4,689 5,971 94.43 27.34 Soybean Oil 82 148 105 138 115 1,020 825 650 692.68 -21.21 TOTALS 142,199 184,145 228,668 209,092 286,710 353,921 432,122 491,799 245.85 13.81 Source: BICO Reports The current biotechnology regulations require all shipments of regulated articles to the Philippines be accompanied by a corresponding declaration of genetically modified organism (GMO) content. The GMO declaration may be issued by a responsible officer from the country of origin; an accredited laboratory; the shipper; and/or the importer. A list of these regulated articles is provided in Annex I and Annex I-A. Section III. Plant Biotechnology Policy: The Philippine agricultural biotechnology regulatory regime is embodied in the DA-AO 8. The responsible Philippine government regulatory agencies and their roles in relation to Philippine biotechnology regulations remain unchanged as reported in the previous annual report. The BPI continues to be the lead-agency in implementing the science-based DA-AO 8. Under the current regulations, 32 TEs have been approved for food, feed or processing materials (see Annex I), marginally higher than the 31 approved TEs posted in the previous annual report. In addition, there were 27 approved stacked trait products as of July 2011, up from the 22 approved products reported in the previous annual report. A summary of approved stacked or combined trait products is provided in Annex I-A. Philippine elections were held May 2010 and President-elect Benigno Aquino III officially assumed office in July 2010. In a message issued during the November 2010 Philippine National Biotechnology Week, President Aquino recognized and extolled the vital role of biotechnology in the national economy, particularly the agriculture sector. On May 13, 2011, President Aquino signed Executive Order No. 43 creating five (5) Cabinet clusters that will direct all efforts to address the key priority areas of his Administration. The clusters are: Good Governance and Anti-Corruption; Human Development and Poverty Reduction; Economic Development; Security, Justice and Peace; and Climate Change Adaptation and Mitigation (CCAM). The CCAM cluster is chaired by the Secretary of the Philippine Department of Environment and Natural Resources, with the Climate Change Commission (CCC) as Secretariat, chaired by President Aquino. The CCAM cluster has the following as members: Chair, Housing and Urban Development Coordinating Council Secretary, Department of Science and Technology Secretary, Department of the Interior and Local Government Secretary, Department of Public Works and Highways Secretary, Department of Social Welfare and Development Secretary, Department of Agriculture Secretary, Department of Agrarian Reform Secretary, Department of Energy Secretary, Department of National Defense Chair, Metropolitan Manila Development Authority Ensuring food security continues to be a major priority of the GPH and as a result, the DA and the CCC have placed adaptation and disaster management at the top of its agricultural climate change concerns. This observation was confirmed by the recent visit to the Philippines by an inter-agency team under the USG?s Enhancing Capacity for Low Emissions Development Strategies initiative. On the issue of halal certification of GE food products, foods derived from GE products are now subject to halal certification, according to the amended Philippine National Standard or PNS 2067/2008 Amd 01:2011. Halal is a term used to designate food seen as permissible according to Islamic law (Sharia, ). Previously, the PNS for Halal Food did not allow halal certification of GE foods. The Philippine DA is also drafting the Halal Standards on Agriculture and Fishery Products; the Code of Halal Slaughtering Practices for Poultry, and the Code of Halal Slaughtering Practices for Large Ruminants. All 3 standards are expected to help the Philippines penetrate the lucrative halal market. Increased global trade of GE products will also be enhanced once a low-level presence policy is established in the Philippines. The Philippine DA, according to contacts, is set to hold sectoral and regional consultations in the near future where GE threshold levels are expected to be discussed. Other recent GPH development issuances, however, have not been as encouraging. In the recently approved 2011-2016 Philippine Development Plan (PDP), which outlines the legislative agenda of the Aquino government, a provision calling for the labeling of raw materials sourced from GE products is included as part of efforts to standardize the food safety and certification system in the Philippines. A proposed bill called the ?Genetically Engineered Food Right to Know Act? is currently pending in the Philippine Senate and the House of Representatives. The PDP likewise supports a precautionary approach in environment risk assessments. Section IV. Plant Biotechnology Marketing Issues: The overall support on the responsible use of modern agricultural biotechnology remains strong although there are still some pockets of resistance. There are currently six (6) municipal or provincial resolutions that restrict GE crop testing and/or cultivation. While some provinces have instituted these bans, many farmer groups want better access to GE seeds. This is particularly the case with GE corn. The fact that multiple international corn seed companies have made sizeable investments in the country in 2010 corroborates this observation. Section V. Plant Biotechnology Capacity Building and Outreach: Other developing countries are increasingly looking to the Philippines for guidance on biotechnology policy and regulations. The country has hosted delegations from Indonesia and Nigeria and has provided key speakers in several international biotechnology events. More international events that feature Filipino scientists and the Philippine biotechnology experience are expected in the near future. In the Philippines, communication strategies that inform the public on the economic, environmental and food security benefits of agricultural biotechnology are encouraged. This strategy is consistent with the recommendation of the 2010 Asia Pacific Economic Cooperation (APEC) High Level Policy Dialogue on Agricultural Biotechnology held in Sapporo, Japan, which highlighted the importance of strategic communication to gain widespread acceptance of biotechnology. The fact that there has been no ill- health related incident in its 15 years of use is also used to promote biotechnology in the country. A FY2010 EMP agricultural biotechnology regulatory outreach activity was successfully carried out in late September 2010 wherein local regulators met and discussed with their U.S. counterparts pertinent biotechnology issues and developments. The Philippine delegation was also able to meet technology developers and provided a preview on what to expect in the near future in relation to pipeline projects soon to be commercialized. A follow up activity has been proposed. Section VI. Animal Biotechnology: There are currently no Philippine research and development projects on transgenic animals, although there is local interest in the topic. A Philippine team is set to participate in a GE animal workshop organized by the International Centre for Genetic Engineering and Biotechnology and the United Nations-University Program for Biotechnology in Latin America and the Caribbean. The workshop will be held in Argentina on September 2011. An APEC GE Animal Regulatory and Risk Communication Workshop for APEC-member countries is expected to optimize the participation of delegates from the Philippines during the Argentina event. Section VII. Author Defined: ANNEX I - APPROVAL REGISTRY FOR THE IMPORTATION OF REGULATED ARTICLES FOR DIRECT USE AS FOOD AND FEED OR FOR PROCESSING (As of July 5, 2011) Transformation Introduced Trait and Gene Date Safety Technology Other Countries with Event Approved Assessment Developer Similar Approval Food Feed 1. Alfalfa J101 Contains cp4epsps coding 08/09/2006 Monsanto USA and Canada and J163 sequence from ? ? Philippines Agrobacterium sp strain, CP4 which confers tolerance to the Roundup family of agricultural herbicides 2. Corn 59122 Contains cry34Ab1 and 08/09/2006 Pioneer Hi- USA, Korea and cry35Ab1 from Bacillus ? ? Bred and Dow Mexico thuringiensis, which confers AgroSciences resistance to certain coleopte ran pests such as corn rootworm, Diabrotica sp. and the pat gene from Streptomyces viridochromogenes which provides tolerance to glufosinate- ammonium herbicides 3. Corn MIR604 Contains modified cry3A 10/08/2007 Syngenta USA, South Korea, (mCry3A) from Bacillus ? ? Philippines Australia and New thuringiensis subsp. Zealand tenebriones which confers resistance to corn rootworm 4. Soybean Contains cp4epsps coding 11/16/2007 Monsanto USA MON89788 sequence from ? ? Philippines Agrobacterium sp. Strain, CP4 which confers resistance tolerance to Round up family of agricultural herbicides 5. Corn MON810 Contains cry1A(b) gene from 12/03/2007 Monsanto Canada, China, Bacillus thuringiensis var. (renewal) ? ? Philippines European Union, kurstaki which confers Japan, Korea, Russia, resistance to corn borer Slovak Republic, Spain, south Africa, Switzerland, USA, Uruguay, Australia and New Zealand, Honduras, Mexico, Colombia and Taiwan (food and feed) 6. Corn 3272 Expresses a synthetic 02/07/2008 Syngenta USA thermostable alpha amylase ? ? Philippines protein AMY797E that catalyzes the hydrolysis of starch into soluble sugars 7. Corn Bt11 Contains the Bt protein from 07/22/2008 Syngenta Argentina, USA Bacillus thuringiensis and (renewal) ? ? Philippines Canada Japan, PAT protein from European Union, Streptomyces Switzerland, Republic viridochromogenes which of South Africa Korea, confer resistance to corn China, Colombia and borer and tolerance to Mexico (food and herbicide respectively feed); United Kingdom, Taiwan and Russia (food); the Netherlands feed) 8. Soybean 40-3- Contains cp4epsps coding 07/22/2008 Monsanto Argentina, Bolivia, 2 sequence from (renewal) ? ? Philippines Brazil, Canada, China, Agrobacterium sp strain, CP4 European Union, which confers resistance Japan, Mexico, tolerance to Round up family Paraguay, Russia, of agricultural herbicides south Africa, Switzerland, USA, the Netherlands, Denmark, Romania, Czech Republic, Poland (food and feed); Australia and New Zealand, Korea, Malaysia, Taiwan, Thailand (food) 9. Corn NK603 Contains cp4epsps coding 09/10/2008 Monsanto Argentina, Australia, sequence from (renewal) ? ? Philippines New Zealand, Canada, Agrobacterium sp. CP4 strain China, Colombia, EU, which confers tolerance to Honduras, Japan, the Roundup family of Korea, Mexico, Russia, agricultural herbicides Singapore, South Africa, Taiwan and United States. 10. Corn Contains cry3Bb1 gene from 10/07/2008 Monsanto Australia and New MON863 Bacillus thuringiensis subsp (renewal) ? ? Philippines Zealand, Canada, kumamotoensis which China, EU, Japan, confers resistance to corn Korea, Mexico, rootworm Russia, Singapore, Taiwan and United States 11. Corn 1507 Contains Cry1F and PAT 10/07/2008 Pioneer Hi- USA, Japan, Canada, proteins which confer (renewal) ? ? Bred and Dow Australia, New resistance to certain AgroSciences Zealand, Taiwan, EU, lepidopteran pests such as South Korea, Mexico, the Asiatic corn borer and China, South Africa, pink borer (Sesamia spp) Argentina, Colombia 12. Corn DBT418 Contains cry1Ac gene from 10/22/2008 Monsanto Argentina, Australia, Bacilllus thuringiensis and (renewal) ? ? Philippines New Zealand, Canada, the bar gene from Japan, Korea, Taiwan, Streptomyces hrygroscopicus United States. that confers tolerance to the herbicide, phosphinotricin 13. Canola Rt 73 Contains cp4epsps coding 10/22/2008 Monsanto Australia, New sequence from (renewal) ? ? Philippines Zealand, Canada, Agrobacterium sp. CP4 strain China, EU, Japan, and the GOXv247 coding Korea, Mexico, sequence from Singapore, United Ochrobactrum anthropi strain States. LBAA that confers tolerance to the Roundup family of agricultural herbicides 14. Corn BT176 Contains Bt protein from 10/24/2008 Syngenta USA, Canada, Bacillus thuringiensis and (renewal) ? ? Philippines Argentina, Japan, PAT protein from Netherlands, Streptomyces Switzerland, South viridochromogenes which Africa, Korea, China confers tolerance to (food and feed) UK, lepidopteran insect pest Denmark, Australia, Taiwan (food) 15. Corn GA21 Contains modified epsps 11/20/2008 Syngenta USA, Canada, Japan, gene from corn which confers (renewal) ? ? Philippines Korea, EU, China tolerance to herbicides South Africa Mexico, Russia (food an feed); Australia and Taiwan (food) 16. Corn DLL25 Contains the bar gene from 10/22/2008 Monsanto USA, Argentina, bacterium, Streptomyces (renewal) ? ? Philippines Canada and China hygroscopicus that confers to herbicide , phosphinotricin 17. Corn T25 Contains PAT protein from 12/05/2008 Bayer USA, Europe, Streptomyces (renewal) ? ? CropScience Switzerland, South viridochromogenes which Korea, South Africa, encodes for tolerance to Argentina, Japan, herbicide, phosphinotricin Australia, New Zealand, China, Canada, Russia, Taiwan 18. Cotton 1445 Contains cp4epsps coding 12/05/2008 Monsanto Argentina, Australia, sequence from (renewal) ? ? Philippines New Zealand, Canada, Agrobacterium sp strain, CP4 China, Colombia, EU, which confers tolerance to Japan, Korea, Mexico, the Roundup family of Singapore, South agricultural herbicides Africa, United States 19. Cotton 15985 Contains the cry2Ab2 and 12/05/2008 Monsanto Australia, New cry1Ac genes which encode (renewal) ? ? Philippines Zealand, Canada, proteins that convey China, EU, Japan, protection from lepidopteran Korea, Mexico, insect pests Singapore, South Africa, United States 20. Potato BT6 Contains cryIIIA coding 12/05/2008 Monsanto Canada, Mexico and (RBBT 02-06) & sequence from Bacillus (renewal) ? ? Philippines USA (Food and Feed); SPBT 02-05 thuringiensis subsp. Japan and Korea tenebriones for tolerance to (food) Colorado potato beetle 21. Potato Contains cryIIIA coding 12/22/2008 Monsanto Australia, Canada, RBMT15-101, sequence from Bacillus (renewal) ? ? Philippines Mexico and USA (food SEMT 15-02 & thuringiensis subsp and feed); Japan and SEMT 15-15 tenebriones strain B1256-82, Korea (food) which confers resistance to Colorado potato beetle and the PVY coat protein (PVYcp) isolated from PVY infected potatoes which confers resistance to the potato virus Y (PVY) 22. Soybean Contains pat gene which 01/23/2009 Bayer Canada, Argentina, A2704-12 confers tolerance to ? ? CropScience Australia, China, EU, glufosinate ammonium Japan, Mexico, Russia, herbicide South Africa, USA (food and feed); New Zealand and Taiwan (food) 23. Cotton 531 Contains cry1Ac gene form 02/05/2009 Monsanto Argentina, Canada, Bacillus thuringiensis var. (renewal) ? ? Philippines China, Colombia, EU, kurstaki which confers Japan Singapore, USA resistance to lepidopteran (food and feed) pests Australia, New Zealand, Korea, Thailand (food) 24. Corn Contains two genes 04/29/2009 Monsanto USA, Canada,, Japan, MON89034 (cry1A.105 and cry2Ab2) ? ? Philippines Mexico and Colombia from Bacillus thuringiensis which protect the plant from Asiatic corn borer, common cutworm and corn earworm 25. Potato Contains cryIIIA coding 10/16/2009 Monsanto Australia, USA, Japan RBMT21-129, sequence which confers (renewal) ? ? Philippines (food and feed); RBMT21-350 and resistance to Colorado potato Canada and Korea RBMT22-82 beetle and resistance to (food) potato leaf roll virus 26. Soybean Contains the gat4601 gene 11/26/2009 Pioneer Hi- USA, Canada, Mexico, DP356043 derived from Bacillus ? ? Bred EU, Japan, Taiwan, licheniformis conferring China, Korea, (food tolerance to glyphosate and and feed) ALS (acetolactate synthase) inhibiting herbicides 27. Corn MIR162 Contains two novel genes: 02/11/2010 Syngenta Brazil and Mexico vip3Aa20 gene from Bacillus ? ? Philippines (food, feed), Japan thuringiensis resistance to (food), Canada (feed) lepidopteran pests and pmi gene from Escherichia coli encoding the enzyme phosphomannose isomerase present as a selectable marker 28. Sugarbeet Contains cp4epsps coding 07/28/2010 Monsanto Australia, Canada, H7-1 sequence from (renewal) ? ? Philippines China, Columbia, Agrobacterium sp. Strain, and KWS European Union, CP4 which confers tolerance SAAT AG Japan, Korea, Mexico, to glyphosate herbicide Singapore, USA 29. Soybean Contains gene csr-2 from 10/29/2010 BASF Australia, Brazil CV127 Arabidopsis thaliana which ? ? Philippines, Canada, China, EU, encodes the imidazoline Inc. Japan, Korea, Mexico, herbicide tolerant South Africa, Taiwan, acetohydroxyacid synthase USA (AtAHAS) 30. Cotton Contains cp4epsps coding 11/26/2010 Monsanto USA, Australia, MON88913 sequence from (renewal) ? ? Philippines Canada, China, Agrobacterium sp strain, CP4 Colombia, Japan, which confers tolerance to Korea, Mexico, the Roundup family of Singapore, South agricultural herbicides Africa 31. Corn Contains Cry3Bb1 protein for 03/21/2011 Monsanto USA, Japan, Australia, MON88017 resistance to the corn (renewal) ? ? Philippines Canada. European rootworm, Diabrotica spp and Union, Korea, CP4EPSPS protein for Singapore tolerance to glyphosate herbicide 32. Soybean Contains a synthetic 06/23/2011 Bayer Argentina, Australia, A5547-127 phosphinothricin ? ? CropScience, Brazil, Canada, Japan, acetyltransferase (pat gene) Inc. Mexico, New Zealand, from Streptomyces Russia, USA viridochromogenes expressing tolerance to glufosinate ammonium herbicide Source of Data: Bureau of Plant Industry ANNEX II - APPROVAL REGISTRY OF REGULATED ARTICLES FOR PROPAGATION (As of July 6, 2011) Transformation Introduced Trait and Gene Date S Other afety Assessment Technology Event* Approved Deve Countries loper with Similar Food Feed Environ- Approval ment 1. Corn GA 21 Contains modified epsps 11/24/2009 Syngenta USA, Canada, gene from corn which Philippines Argentina, confers tolerance to herbicides 2. Corn Contains cry1Ab gene from 12/03/2007 Monsanto Argentina, MON810 Bacillus thuringiensis var (renewal) Philippines Canada, EU, kurstaki which confers Japan, South resistance to corn borer Africa, USA 3. Corn NK603 Contains cp4epsps coding 03/16/2010 Monsanto Brazil, sequence from (renewal) Philippines Canada, Agrobacterium sp. CP4 Argentina, strain which confers USA, Japan, tolerance to the Roundup South Africa, family of agricultural herbicides 4. Corn Bt 11 Contains the cry1Ab gene 04/23/2010 Syngenta USA, Canada, from Bacillus thuringiensis (renewal) Philippines Argentina, and pat gene from Japan, Streptomyces Republic of viridochromogenes which South Africa, confers resistance to corn Uruguay, borer and tolerance to Brazil, and herbicide, respectively Colombia 5.Corn Contains the cry1A.105 and 11/19/2010 Monsanto Canada, MON89034 cry2Ab2 genes from Philippines Japan, USA Bacillus thuringiensis that are active against lepidopteran insects * Transformation events approved for propagation are also approved for direct use for food and feed or for processing. Source of Data: Bureau of Plant Industry ANNEX I-A - APPROVAL REGISTRY FOR THE IMPORTATION OF COMBINED TRAIT PRODUCTS FOR DIRECT USE AS FOOD, FEED AND FOR PROCESSING (As of July 6, 2011) Interaction Comb of the ined Introduced Trait and Gene Date Technology Other Trait resulting Product* Approved Developer Countries with gene Similar products Approval Yes No 1. Corn LY038 Contains cordapA coding sequence 08/09/2006 Monsanto USA x Corn which is under the control of the maize Philippines MON810 Glb1 promoter that expresses the Corynebacterium glutamicum derived lysine insensitive dihydrodipicolinate synthase enzyme in the germ to increase the level of lysine in grain for animal feed applications and cry1Ab gene from Bacillus thuringiensis var kurstaki which confers resistance to corn borer 2. Corn 59122 Contains cry34Ab1 and cry35Ab1 from 12/20/2006 Pioneer Hi- USA, Canada, x Corn NK603 Bacillus thuringiensis, which confers Bred, Japan, resistance to certain coleopteran pests Philippines Australia, New such as corn rootworm, Diabrotica sp. Zealand and and the pat gene from Streptomyces Korea viridochromogenes which provides tolerance to glufosinate- ammonium herbicides and cp4epsps coding sequence from Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides. 3. Corn Bt11 x Contains the cry1Ab gene from Bacillus 01/23/2007 Syngenta United States Corn GA21 thuringiensis and pat gene from Philippines and Canada Streptomyces viridochromogenes which (food and feed), confer resistance to corn borer and Korea (food) tolerance to herbicide respectively and modified epsps gene from corn which confers tolerance to herbicides 4. Corn Contains cry1F which confers 01/23/2007 Pioneer Hi- USA, Canada, TC1507 x Corn resistance to certain lepidopteran pests Bred, Japan, 59122 such as the Asiatic corn borer and pink Philippines and Australia, New borer (Sesamia spp) and cry34Ab1 and Dow Agro Zealand Korea cry35Ab1 from Bacillus thuringiensis, Sciences and Mexico which confers resistance to certain coleopteran pests such as corn rootworm, Diabrotica sp. and the pat gene from Streptomyces viridochromogenes which provides tolerance to glufosinate- ammonium herbicides 5. Corn 59122 Contains cry34Ab1 and cry35Ab1 from 02/07/2007 Pioneer Hi- USA, Canada, x Corn TC1507 Bacillus thuringiensis, which confers Bred, Japan, x Corn NK 603 resistance to certain coleopteran pests Philippines Australia, New such as corn rootworm, Diabrotica sp. Zealand Korea and the pat gene from Streptomyces and Mexico viridochromogenes which provides tolerance to glufosinate- ammonium herbicides Contains cry1F from Bacillus thuringiensis (Bt) var. aizawai controlling certain lepidopteran pests such as European corn borer, southwestern corn borer, fall armyworm and black cutworm. Contains cp4epsps coding sequence from Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides 6. Corn Bt11 x Contains the cry1Ab gene from Bacillus 12/13/2007 Syngenta Korea, Japan Corn MIR604 thuringiensis and pat gene from Philippines and USA Streptomyces viridochromogenes which confers resistance to corn borer and tolerance to herbicide respectively and modified cry3A (mCry3A) from Bacillus thuringiensis subsp. tenebriones which confers resistance to corn rootworm 7. Corn Contains modified cry3A (mCry3A) from 12/13/2007 Syngenta Korea and MIR604 x Corn Bacillus thuringiensis subsp. Philippines Japan GA21 tenebriones which confers resistance to corn rootworm and modified epsps gene from corn which confers tolerance to herbicides 8. Corn Bt11 x Contains the cry1Ab gene from Bacillus 03/03/2008 Syngenta Korea Corn MIR604 x thuringiensis and pat gene from Philippines Corn GA21 Streptomyces viridochromogenes which confer resistance to corn borer and tolerance to herbicide respectively and modified cry3A (mCry3A) from Bacillus thuringiensis subsp. tenebriones which confers resistance to corn rootworm and modified epsps gene from corn which confers tolerance to herbicides 9. Corn Contains two genes (cry1A.105 and 07/22/2009 Monsanto USA, Canada MON89034 x cry2Ab2) from Bacillus thuringiensis Philippines and Japan Corn NK603 which protect the plant from Asiatic corn (food) and feed): borer, common cutworm and corn Taiwan (food) earworm and cp4epsps coding sequence from Agrobacterium sp CP4 strain which confers tolerance to the Roundup family of agricultural herbicides. 10. Corn Contains two genes (cry1A.105 and 10/19/2009 Monsanto USA, Canada MON89034 x cry2Ab2) from Bacillus thuringiensis Philippines and Japan Corn which protect the plant from Asiatic corn (food) and feed); MON88017 borer, common cutworm and corn Taiwan (food) earworm and contains Cry3Bb1 protein for resistance to the corn rootworm, Diabrotica spp and CP4EPSPS protein for tolerance to glyphosate resistance 11. Corn Contains cry1Ab gene from Bacillus 01/08/2010 Monsanto USA, Canada MON810 x thuringiensis var kurstaki which confers (renewed) Philippines Argentina, Corn NK603 resistance to corn borer and cp4epsps Brazil, El coding sequence from Agrobacterium Salvador, EU, sp. CP4 strain which confers tolerance Japan, Korea, to the Roundup family of agricultural Mexico, South herbicides Africa (food and feed), Taiwan (food) 12. Corn Contains cry1Ab gene from Bacillus 01/08/2010 Monsanto USA, Canada MON810 x thuringiensis var kurstaki which confers (renewed) Philippines Japan, Korea, Corn MON863 resistance to corn borer and cry3Bb1 Mexico, (food gene from Bacillus thuringiensis subsp and feed), kumamotoensis which confers Taiwan (food) resistance to corn rootworm 13. Corn Contains cp4epsps coding sequence 01/08/2010 Monsanto USA, Canada, NK603 x Corn from Agrobacterium sp. CP4 strain (renewed) Philippines Japan and MON863 which confers tolerance to the Roundup Mexico (food); family of agricultural herbicides and USA, Canada cry3Bb1 gene from Bacillus and Japan thuringiensis subsp kumamotoensis (feed) which confers resistance to corn rootworm 14. Cotton 531 Contains cry1Ac gene from Bacillus 01/08/2010 Monsanto Argentina x Cotton 1445 thuringiensis var. kurstaki, which (renewed) Philippines Australia, Brazil, confers resistance to lepidopteran pests Canada, and cp4epsps coding sequence from Columbia, EU, Agrobacterium sp strain, CP4 which Japan, Korea, confers tolerance to the Roundup family Mexico, and of agricultural herbicides South Africa 15. Cotton Contains the cry2Ab2 and cry1Ac genes 01/08/2010 Monsanto USA, Canada 15985 x Cotton which encode proteins that convey (renewed) Philippines Japan, EU, 1445 protection from lepidopteran insect Korea, Mexico pests and cp4epsps coding sequence from Agrobacterium sp strain, CP4 which confers tolerance to the Roundup family of agricultural herbicides 16. Corn Contains cry3Bb1 gene from Bacillus 02/05/2010 Monsanto USA, Canada MON863 x thuringiensis subsp kumamotoensis (renewed) Philippines and Japan Corn MON810 which confers resistance to corn x Corn NK603 rootworm and cry1Ab gene from Bacillus thuringiensis var kurstaki which confers resistance to corn borer and cp4epsps coding sequence from Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides 17. Corn MON Contains cry1Ab gene from Bacillus 02/08/2010 Monsanto USA, Canada, 810 x Corn thuringiensis var. kurstaki which renders (renewed) Philippines EU, Japan, GA21 resistance to corn borer and modified Korea, and epsps gene from corn which confers south Africa resistance to herbicide 18. Corn Contains two genes (cry1A.105 and 02/09/2010 Monsanto USA, Canada MON89034 x cry2Ab2) from Bacillus thuringiensis Philippines and and Japan Corn 1507 x which protect the plant from Asiatic corn Dow Agro Corn 88017 x borer, common cutworm and corn Sciences Corn 59122 earworm Contains cry1F gene from Bacillus thuringiensis which confers resistance to certain lepidopteran pests such as the Asiatic corn borer and pink borer (Sesamia spp) and the pat gene from Streptomyces viridochromogenes which provides tolerance to glufosinate- ammonium herbicide. Contains cry3Bb1 gene from Bacillus thuringiensis which confers resistance to the corn rootworm, Diabrotica spp and cp4epsps gene from Agrobacterium sp. which confers tolerance to glyphosate Contains cry34Ab1 and cry35Ab1 genes from Bacillus thuringiensis, which confers resistance to certain coleopteran pests such as corn rootworm, Diabrotica sp. 19. Corn Contains cp4epsps coding sequence 04/22/2010 Monsanto USA and NK603x Corn from Agrobacterium sp CP4 strain Philippines Canada T25 which confers tolerance to the Roundup family of agricultural herbicides and pat gene from Streptomyces viridochromogenes which encodes for tolerance to herbicide phosphinotricin 20. Corn Bt11 Contains the cry1Ab gene from Bacillus 07/28/2010 Syngenta USA (food and x Corn MIR162 thuringiensis and pat gene from Philippines feed), Japan x Corn GA21 Streptomyces viridochromogenes which (food) confers resistance to corn borer and tolerance to herbicide respectively, vip3Aa20 gene from Bacillus thuringiensis resistance to lepidopteran pests and pmi gene from phosphomannose isomerase present as a selectable marker and modified epsps gene from corn which confers tolerance to herbicides 21. Corn 3272 Expresses a synthetic thermostable 07/28/2010 Syngenta USA (food and x Corn Bt11 x alpha amylase gene, amy797E that Philippines feed), Japan Corn MIR604 x catalyzes the hydrolysis of starch into (food) Corn GA21 soluble sugars; contains the cry1Ab gene from Bacillus thuringiensis and pat gene from Streptomyces viridochromogenes which confers resistance to corn borer and tolerance to herbicide respectively, vip3Aa20 gene from Bacillus thuringiensis resistance to lepidopteran pests and pmi gene from Escherichia coli encoding the enzyme phosphomannose isomerase present as a selectable marker and modified epsps gene from corn which confers tolerance to herbicide 22. Corn BT11 Contains the cry1Ab gene from Bacillus 12/10/2010 Syngenta USA (food and x Corn MIR162 thuringiensis and pat gene from Philippines feed); and x Corn MIR604 Streptomyces viridochromogenes which Japan (food) x Corn GA21 confers resistance to corn borer and tolerance to herbicide respectively, vip3Aa20 gene from Bacillus thuringiensis resistance to lepidopteran pests and pmi gene from Escherichia coli encoding the enzyme phosphomannose isomerase present as a selectable marker and modified cry3A (mcry3A) from Bacillus thuringiensis subsp. tenebriones which confers resistance to corn rootworm and modified epsps from corn which tolerance to herbicides 23. Corn Contain two genes (cry1A.105 and 12/10/2010 Dow Agro USA, Canada, MON89034 x cry2Ab2) from Bacillus thuringiensis Sciences and Japan and Corn TC1507 x which protect the plant from Asiatic corn Monsanto Australia Corn NK603 borer, common cutworm and corn Philippines earworm Contains cry1F gene from Bacillus thuringiensis which confers resistance to certain lepidopteran pests such as the Asiatic corn borer and pink borer (Sesamia spp) and the pat gene from Streptomyces viridochromogenes which provides tolerance to glufosinate- ammonium herbicide Contains cp4epsps coding sequence from Agrobacterium sp CP4 strain which confers tolerance to the Roundup family of agricultural herbicides 24. Corn Bt11 Contains the cry1Ab gene from Bacillus 12/22/2010 Syngenta Japan x Corn MIR162 thuringiensis and pat gene from Philippines x Corn TC1507 Streptomyces viridochromogenes which x Corn GA21 confers resistance to corn borer and tolerance to herbicide respectively. Contains the vip3Aa20 gene from Bacillus thuringiensis which confers resistance to lepidopteran pests and pmi gene from Escherichia coli encoding the enzyme phosphomannose isomerase present as a selectable marker Contains cry1F gene from Bacillus thuringiensis which confers resistance to certain lepidopteran pests such as the Asiatic corn borer and pink borer (Sesamia spp) and the pat gene from Streptomyces viridochormogenes which provides tolerance to glufosinate- ammonium herbicide. Contains the modified epsps gene from corn confers tolerance to herbicides 25. Corn Contains cry1F from Bacillus 02/17/2011 Pioneer Hi- Argentina, TC1507 x Corn thuringiensis, which confer resistance to (renewed) Bred and Dow Australia/ New NK603 certain lepidopteran pests such as the AgroSciences Zealand, Brazil, Asiatic corn borer and pink borer Canada, (Sesamia spp) and pat genes from Columbia, EU, Streptomyces viridochromogenes, Japan, South which provides tolerance to glufosinate- Korea, Mexico, ammonium herbicides and cp4epsps Taiwan, USA, coding sequence from Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides 26. Cotton Contains the cry2Ab2 and cry1Ac genes 04/20/2011 Monsanto Australia, 15985 x RR which encode proteins that convey (renewed) Philippines Canada, Flex Cotton protection from lepidopteran insect Colombia, (MON88913) pests and the cry3Bb1 gene from Japan, Korea, Bacillus thuringiensis subs Mexico, South kumamotoensis which confers Africa resistance to corn root worm and the cp4epsps coding sequence from Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides 27. Corn MON Contains cry3Bb1 for resistance to the 07/01/2011 Monsanto USA, EU, Japan 88017 x Corn corn rootworm, Diabrotica spp and (renewed) Philippines , Korea MON810 cp4epsps for tolerance to glyphosate (food/feed); resistance and cry1Ab gene from Mexico, Taiwan Bacillus thuringiensis var kurstaki which (food); Canada confers resistance to corn borer (feed) Source of Data: Bureau of Plant Industry ANNEX II-A - APPROVAL REGISTRY OF COMBINED TRAIT PRODUCTS FOR PROPAGATION (As of July 6, 2011) Interaction of the Combined Introduced Trait and Gene Date resulting gene Technology Other Trait Approved products Developer Countries Product* Yes No with Similar Approval 1.Corn Contains cry1Ab gene from Bacillus 07/19/2005 onsanto USA and M MON810 x thuringiensis var kurstaki which Philippines Canada Corn NK603 confers resistance to corn borer and cp4epsps coding sequence from Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides 2. Corn Bt11 Contains the cry1Ab gene from 09/06/2010 a USA, Syngent x Corn Bacillus thuringiensis and pat gene Philippines Canada, GA21 from Streptomyces Brazil and viridochromogenes which confers Argentina resistance to corn borer and tolerance to herbicide respectively and modified epsps gene from corn which confers tolerance to herbicides 3. Corn Contains the cry1A.105 and 03/04/2011 Japan, Monsanto USA, MON 89034 cry2Ab2 genes from Bacillus Philippines Canada, x Corn thuringiensis that are active against Argentina, NK603 lepidopteran insects and cp4epsps Brazil and coding sequence from South Africa Agrobacterium sp. CP4 strain which confers tolerance to the Roundup family of agricultural herbicides * Combined trait product approved for propagation is also approved for direct use as food and feed or for processing. Source of Data: Bureau of Plant Industry
Posted: 29 September 2011, last updated 29 September 2011

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