Colombia. Agricultural Biotechnology Annual. Jun 2013 Nov. 3, 2013
Biotechnology in Colombia has continued to develop over the last year. The adoption rate of genetically engineered (GE) corn has surpassed GE cotton. The Government of Colombia (GOC) Ministry of Health and Social Protection (MHSP) continues to develop a biotechnology regulatory framework with a Technical Annex to supplement Resolution 4253 of 2011. The Technical Annex will be issued in late 2013 and will establish requirements for labeling foods derived from modern biotechnology, identification of raw materials and low level presence (LLP) thresholds.
Section I. Executive Summary:
Colombia is a key Latin American market for U.S. agricultural products with export values over US$1 billion in 2012. The implementation of the U.S.-Colombia Trade Promotion Agreement (CTPA) has opened the market for increased trade opportunities between the two countries. U.S. exports in products derived from biotechnology or genetic engineering such as corn, cotton, soybeans and soybean meal were valued at over US$300 million in 2012.
The Colombian legal framework for agricultural biotechnology regulations is under continual review. Colombia approved the Cartagena Protocol on Biosafety (CPB) in 2002. In 2005, Decree 4525 was published to implement the CBP and since then several other Ministerial resolutions were published to outline specific requirements and procedures for approving and using GE products in Colombia. Colombia’s biotechnology regulations are regularly reviewed and revised, which provides opportunities to engage GOC regulatory counterparts with training activities to facilitate the adoption of science-based regulations. The GOC has created three technical biotechnology committees to analyze environmental, biosafety and food safety impacts of biotech-derived products (see Part B, Policy). The MHSP issued resolution 4254 establishing the requirements for labeling of foods derived from modern biotechnology. The resolution entered into force at the end of June, 2012. In addition to the resolution, the GOC is working on a Technical Annex which supplements the resolution and is expected to be issued in late 2013.
In 2002, GE cotton was approved and was the first biotech plant cultivated on a non-restricted commercial basis in Colombia. GE corn was approved in 2007 and has recently surpassed GE cotton adoption with area planted increasing to 75 thousand hectares in 2012. Also, GE Dutch blue carnations continue to be produced under greenhouse conditions for export to Europe as well as GE blue petal roses for exports to Japan.
Regarding animal biotechnology, Colombia continues to do some work on GE vaccines for animal diseases.
CHAPTER 1: PLANT BIOTECHNOLOGY
PART A: Production and Trade
Colombia has not developed any biotechnology crops to date. There are several Colombian organizations conducting specific research projects. The Colombian sugar cane research center (CENICAÑA) is developing a sugar cane variety resistant to the yellow leaf virus. The International Center for Tropical Agriculture (CIAT) is researching GE rice and cassava. The Colombian Coffee Research Center (CENICAFE) is developing a coffee variety that is resistant to coffee borer (broca) and the International Corporation for Biological Research (CIB) is investigating potatoes resistant to some lepidopterous insects. Colombian universities and research institutes are working together to develop rice and potato biotechnology events. There is increasing GOC and farmer interest to expedite the development of biotechnology events that enhance competitive benefits local crops that are sensitive to imports. All varieties of events that are developed must go through the standard approval process whether intended for human consumption and/or animal feed.
Prior to 2006, the only GE plants approved on a non-restricted commercial basis in Colombia were the cotton varieties Bollgard and Roundup-Ready. In February 2007, the GOC approved the first stacked event, a variety combining Bollgard and Roundup-Ready traits. The GOC also approved planting of GE corn. In 2010, GE soybean was approved for commercial cultivation; however, no area has yet to be planted. Biotech blue carnations and blue petal roses are approved for commercial production and only for export. Total area planted for these ornamental crops is 12 hectares each. In 2012, Colombia planted 75 thousand hectares of GE corn and 28 thousand hectares of GE cotton. GE cotton area planted fell by 21 thousand hectares due to unfavorable growing conditions and low prices due to import competition. On the other hand, GE corn area planted increased 15,807 hectares with corn adoption expanding significantly since 2007, taking over GE cotton as the most widespread GE plant cultivated in Colombia.
In addition to the above-mentioned GE events, there are pending license applications for several other crops that are in varying phases of approval.
Dutch blue carnations continue to be produced under greenhouse conditions for export to Europe as well as blue petal roses for exports to Japan. In 2012, total area planted increased to 24 hectares, or 12 hectares for each ornamental crop. The production of blue petal roses will continue to be destined to the Japanese market where a rose of this kind will be sold for $40-$50 each.
GE seeds are imported mostly from the United States and occasionally from South Africa, Argentina and Australia (see appendices A and B for more details).
Food Aid Recipient Country
Colombia receives limited food aid from the United States. There are no biotech related restrictions on the food aid if the food product contains a GE event that is approved in Colombia for human consumption.
PART B: Policy
The following Ministries are involved in the regulation of agriculture biotechnology and/or conducting risk assessments:
• Ministry of the Environment, Housing and Territorial Development (MEHTD);
• Ministry of Health and Social Protection (MHSP);
• Ministry of Agriculture and Rural Development (MARD);
• Colciencias (Colombian Entity for the Development of Science and Technology);
• National Institute for the Surveillance of Food and Medicines (INVIMA);
• Colombian Institute for Agriculture and Livestock (ICA).
The MARD is a strong supporter of agricultural biotechnology and is developing a regulatory framework to implement the CPB. The Ministry is considerate of the trade implications of the CBP and understands that the Protocol specifically focuses on trans border movement of any GE events resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity.
Decree 4525 of December 6, 2005, established three interagency committees composed of the above-mentioned Ministries that are responsible for biosafety issues and the evaluation and approval of biotech events:
National Technical Committee for Agriculture, Fishery, Forestry and Agro-industry (CTN-Bio): CTN-Bio’s role is to assess GE events for the listed sectors. Although the committee has been approving new-to-market GE products, the MEHTD has voiced concerns regarding the environmental impact of events. The time taken to conduct the risk assessment varies since all dissenting concerns by the different ministries must be resolved before a product is approved.
National Technical Committee for Environment (CTN-Environment): This committee's function is to assess biotechnology events for introduction of GE events that impact the environment. CTN-Environment has yet to receive any requests for review of GE events. However, in May 2010, the MEHTD issued resolution 957 establishing procedures on what companies must submit for evaluation and what the Ministry process of assessing GE events. The committee is now fully operational.
National Committee for Health and Human Nutrition (CTN-Health): CTN-Health's function is to as assess the impact of genetically modified events in GE products and by-products on human health. On February 1, 2007 the Ministry of Health and Social Protection issued resolution 227 to establish the
functions of the committee making it fully operational. In fact, CTN-Health has submitted a number of recommendations for approval to the Ministry of Health and Social Protection which continues to take long to issue resolutions. However, the industry and the US Government are still pressing the Ministry to streamline their processes, thus creating room for a predictable timetable for issuing resolutions.
The Government of Colombia only allows approved biotech events for commercial cultivation/environmental release. The approval process requires each variety with a specific genetic trait to be approved. This process can be lengthy. Approvals for feed and food consumption are carried out separately by the CTN-Bio and CTN-Health, respectively. This parallel approval process can result in asynchronous circumstances, with some biotech events being approved for food, but not for feed, and others for cultivation, but not for food. See appendix B for more details.
Colombia allows field-testing for biotechnology crops after a risk assessment is submitted to CTN-Bio for review and approval.
Regarding “stacked” events, CTN-Bio requires additional or duplicative field testing. Even though the individual events may have already been approved, the “stacked” variety must go through the approval process. It is worth mentioning that stacked events (resistant to some lepidopterous pests and tolerant to Roundup herbicide) continue to be the variety mostly planted in Colombia.
There are no regulations for coexistence between biotechnology and non-biotechnology crops in Colombia. However, ICA has carried out an evaluation of cross-pollination on cotton and found that both GE and non-GE crops do coexist. Regardless, farmers actively apply the practice of buffer zones or a natural barrier of fallow terrain between the two plantings.
The MHSP issued Resolution 4254 establishing the requirements for labeling of food derived from modern biotechnology. The resolution requires labeling information regarding product health and safety, such as potential allergenicity. Labeling must also address functionality or use of the food as well as the identification of significant differences in essential characteristics of the food. In addition to the resolution, the Colombian government is working on a Technical Annex which supplements the resolution and is expected to be issued in late 2013. Agricultural traders and the food industry that deal with biotech-derived commodities will have to comply with the new requirements to ensure shipments for human consumption entering Colombia are approved. Industry and commodity exporters have expressed their concerns as not all GE events in international commercial use have been approved in Colombia. This could potentially delay shipments. Regarding labeling for imported GE materials (seeds or other plant reproductive materials and animal products), ICA issued Resolution 946 of April 17, 2006, stating that imported GE materials should be labeled as “Genetically Modified Organisms” or in Spanish "ORGANISMO MODIFICADO GENETICAMENTE”. This requirement is justified as a consumer-right-to-know obligation.
Intellectual Property Rights
Regarding intellectual property rights (IPR), Colombia follows the guidelines provided as a member of the following groups: the Paris Convention for the Protection of Industrial Property, the General Agreement on Tariffs and Trade (GATT), the International Union for the Protection of New Varieties of Plants (UPOV), the G3 Agreement between Mexico, Colombia and Venezuela, and the Andean Pact. As a member of the Andean Pact, Colombia adopted Decision 351- Common Provisions on the Protection of the Rights of Breeders of New Plant Varieties and Decision 391, Common Regime on Access to Genetic Resources. (Hodson & Carrizosa, 2007). In spite of the IPR regulatory framework, domestic and international biotech industries have reported that issues remain regarding patents for GE technologies. The Colombian Patent Authority for Industry and Trade takes excessive time to grant patents causing the biotechnology industry to reduce the number of new technologies petitioned for use in Colombia. In addition to the lengthy process, the Colombian law pertaining intellectual property rights, Law 1032 of June 22, 2006, Article 306 for the usurpation of intellectual property is not being fully enforced. Industry sources claim that the lack of knowledge on the part of patent law judges regarding GE materials prevents the judicial system from making sound and timely decisions on biotech patents.
Cartagena Protocol Ratification
As a signatory (and host) to the CPB, Colombia approved the Biosafety Protocol through Law 740 in 2002, eventually being implemented in September 2003. To date, the regulations to implement the CPB supporting laws are outlined in decree 4525 of December 6, 2005; ICA resolution 1063 of March 22, 2005; ICA resolution 000946 of April 17, 2006; MHSP resolution 0227 of February 1, 2007 and MEHTD resolution 957 of May 19, 2010.
Colombia plays an active role in the discussions of the CPB Conference of the Parties as a signatory. In addition to CPB meetings, Colombia is also a signatory to the International Treaty on Plant Genetic Resources for Food and Agriculture, the International Plant Protection Convention (IPPC), and attends CODEX meetings to discuss issues on biotechnology.
Monitoring and Testing
In 2009, the GOC issued resolution 682 requiring GE seed companies to adopt a life cycle stewardship approach to accompany producers which had only been applied to cotton crops. In September 2010, a resolution was issued for handling GE corn which outlines the role for farmers and GE seed companies. Both resolutions have established a commercial road map for the two main GE crops in Colombia to ensure that the technology continues to be effective. Colombia is not actively testing for GE products. However, Government officials are considering port of entry testing at GOC laboratories for GE detection and surveillance to ensure exporters will comply with the Technical Annex upon implementation.
Low Level Presence
The Technical Annex will supplement Resolution 4254, requiring that GE events imported in Colombia, intended for human consumption, must be approved. Considering the lengthy amount of time that Colombian regulatory officials take to review and approve new GE events, the GOC has proposed a 2 percent LLP threshold to address asynchronous approvals; however, that threshold remains under review. The LLP threshold will only apply to GE events for food consumption and not feed raw materials.
PART C: Marketing
Biotechnology has existed in Colombia for the last 13 years. Most press coverage is favorable to biotechnology. To date, consumers have not voiced major concerns about GE products or products containing GE raw materials.
Although Colombia’s approach to biotechnology has been favorable, some environmental groups are pressing government officials to reject biotech products. In addition, some indigenous groups have been inspired by NGOs to oppose the introduction of GE events based on biodiversity concerns. The GOC’s structure for biotechnology regulations is based on science-based decisions of accepting or rejecting new biotechnology events. The basic principle is to adopt the technologies that may help the economic/social development of Colombia. The MEHTD has been the most controversial voice on biotechnology approvals.
A preliminary IFPRI study (Zambrano et al. 2011) on the benefits of biotech cotton for women indicates that it saved them time and money. However, there is lack of information on the various services related to biotech cotton. The study confirmed that the gender focus on women is an important aspect and needs more detailed study in Colombia, where women, play a key role as practitioners in biotech cotton production. (Excerpt from: James, Clive. 2011. Global Status of Commercialized Biotech/GM Crops: 2011. ISAAA Brief No. 43. ISAAA: Ithaca, New York).
PART D: Capacity Building and Outreach
FAS/Bogotá has been working together with different industry groups to disseminate information on the benefits of biotechnology and collaborating on the following activities:
• September 2003: Three leading Colombian journalists attended a biotechnology tour in the United States;
• July 2004: Two Colombian officials from ICA and Von Humboldt Institute attended a two-week “Biotech Short Course” on regulatory and trade issues at Michigan State University;
• August 2004: Farmer-to-Farmer Biotechnology Workshop was held at the University of Zamorano in Honduras, which a leading Colombian cotton producer and agricultural leader attended;
• February 2006: a Cochran candidate attended a tailor-made program in the United States on biotechnology;
• July 23-25 2007: FAS and State jointly sponsored a biotechnology conference for Government officials held in Bogota followed by meetings with research organizations in Cali;
• September 2007: 2 Cochran candidates from INVIMA attended biotechnology training in
Washington, St. Louis and Texas A&M;
• September 2008: FAS and State jointly sponsored a seminar for government officials, private sector, academia and producers associations to address issues regarding labeling of GE products, the implementation of the Cartagena Biosafety Protocol and environmental concerns;
• September 2008: FAS supported Agrobio (an association of private companies producing biotechnology products) in an effort to educate Latin American researchers on GE monitoring and detection;
• September 2009: FAS and the US Grains Council took two Colombian regulators one from the Ministry of Environment and the other one from Colciencias to visit regulators in Washington, D.C. and a visit Iowa to see biotechnology risk-management practices in the field;
• September 2009: A Colombian official from the Von Humboldt Institute attended a two-week “Biotech Short Course” on regulatory and trade issues at Michigan State University;
• July 2010: FAS and State jointly sponsored a visit from a scholar to speak on biotechnology during a three-day program in Bogota and Medellin. While in Bogotá, he addressed an audience on biotechnology and nutrition, gave a presentation to some media representatives and held a side meeting with the CTN Health to discuss policy issues. The itinerary in Medellin included two presentations at Agrofuturo, an annual event sponsored by the Ministry of Agriculture, where the speaker was able to discuss the benefits of biotechnology and food security
• July 2010: 3 Colombian officials from the Ministry of Environment, ICA and the Ministry of Social Protection attended the Biosafety short course in Michigan State University under the Cochran program;
• September 2010: 3 Colombian officials from ICA, the National University and Colciencias attended the Biotechnology short course in Michigan State University under the Cochran program;
• July 2011: FAS and State partnered with Agrobio, a NGO in charge of promoting biotechnology, and coordinated a visit of a biotechnology expert to conduct a media tour with Colombian journalists to Palmira, Villavicencio, Montería, Ibague and Bogota;
• August 2011: FAS coordinated with State a voluntary program on biotechnology and intellectual property rights for a group of 9 Colombian representatives from academia and associations to St. Louis, Davis, and Washington D.C;
• August 2012: FAS in collaboration with the USGC organized a visit of a team of government regulators in charge of implementing resolution 4254 on labeling law for GE products in Colombia and some representatives of the corn milling industry to attend a week program in Washington, D.C. and New Orleans;
• February 2013: First Colombian Borlaug fellow from FEDEARROZ, National Rice Producers Association, attended a 4 month biotechnology program at Georgia University;
• April 2013: FAS in collaboration with the USGC organized a visit of a team of government regulators and a group if industry representatives to a week program in Washington, DC and St. Louis to discuss LLP and trade impact;
• June 2013: FAS in collaboration with the USGC and ANDI, National Industries Association, organized a two day seminar to discuss low level presence as opposed to zero tolerance and the Mexican experience with grain trade.
Colombia would greatly benefit with more aggressive educational efforts on biotechnology issues. Therefore, FAS/Bogota would like to continue working with appropriate US agencies to develop projects and programs that strengthen biotechnology knowledge and understanding. Some activities may include:
• Attendance to FAO LLP workshops and the Global LLP Initiative would assist GOC officials in making final decisions on LLP policy;
• An emphasis on the media by organizing a follow-up activity to the media tour in 2003 would help solve some of public misconceptions;
• Educational programs for GOC officials and researchers through Cochran and Borlaug will continue to strengthen biotechnology knowledge.
CHAPTER 2: ANIMAL BIOTECHNOLOGY
PART E: Production and Trade
Colombia has done limited work on animal biotechnology for developing pharmaceuticals and vaccines to be used for humans and animals (see appendix C). According to GOC officials, research is in the initial stages with an informal request of information and submission of a research proposal on GE bovine production of lactose free milk. Regarding human health, academia has submitted three proposed research projects on the use of GE mice for research. One proposal for GE mice is pending approval.
PART F: Policy
The Government of Colombia has established a regulatory framework for plant biotechnology that also applies to animal biotechnology. The three interagency committees that are responsible for evaluation and approval of plant biosafety issues are also responsible for GE animal approvals.
PART G: Marketing
Public knowledge of biotechnology is mostly related to plants. Animal biotechnology is not well known and gets little media attention