Colombia. Agricultural Biotechnology Annual. Jul 2014 Aug. 1, 2014
The production of biotech-derived commodities continues to expand with the adoption rate of genetically engineered (GE) corn surpassing 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 be issued in late 2014. The Annex will establish requirements for labeling foods derived from modern biotechnology, identification of raw materials and low level presence (LLP) thresholds.
I. Executive Summary:
Colombia is a key Latin American market for U.S. agricultural products with export values over US$1.5 billion in 2013. The implementation of the U.S.-Colombia Trade Promotion Agreement (CTPA) has increased trade opportunities. U.S. exports in products derived from biotechnology or genetic engineering such as corn, cotton, soybeans, soybean meal, soybean oil, and distillers grains were valued at over US$500 million in 2013.
The Colombian legal framework for agricultural biotechnology regulations remains under 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 outreach 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 2014.
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 continues to surpass GE cotton adoption with area planted increasing to 75 thousand hectares in 2013. 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 import GE vaccines for animal diseases.
II. Plant Biotechnology
PART A: Production and Trade
a) Product Development
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 conducting GE research on tobacco (nicotiana), the fungus Beaveria bassiana, and a coffee variety resistant to coffee borer (broca). 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 for local crops that are sensitive to competition from imports. All varieties of events that are developed must go through the regulatory approval process whether intended as an ornamental, for human consumption and/or animal feed.
b) Commercial Production
Prior to 2006, the only non-restricted GE approval in Colombia was for the cotton varieties Bollgard and Roundup-Ready. In February 2007, the GOC approved the first stacked event, a cotton variety combining Bollgard and Roundup-Ready traits. The GOC also approved controlled planting of GE corn. In 2010, GE soybean production was approved for commercial cultivation, but 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 2013, Colombia planted 75 thousand hectares of GE corn and 27 thousand hectares of GE cotton. GE cotton area planted fell by 1,259 hectares due to unfavorable growing conditions and low prices. On the other hand, GE corn area planted increased slightly by 49 hectares with GE 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 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 2013, area planted remained the same: 12 hectares for Dutch blue carnations and 12 hectares for blue petal roses. One blue petal rose in the Japanese retail market has an estimated value of about US$40-50.
GE seeds are imported mostly form the United States and occasionally from South Africa, Argentina and Australia.
e) Food Aid Recipient Country
Colombia receives limited food aid from the United States. Any food aid containing GE events must have regulatory approval in Colombia for human consumption.
III. Plant Biotechnology Policy
a) Regulatory Framework
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);
• MHSP National Institute for the Surveillance of Food and Medicines (INVIMA);
• MARD Colombian Institute for Agriculture and Livestock (ICA).
The MARD is supportive 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 GE events derived 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 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 GOC only permits approved biotech events for commercial cultivation and/or environmental release. The approval process requires each variety with a specific GE 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.
c) Field Testing
Colombia allows field-testing for biotechnology crops after a risk assessment is submitted to CTN-Bio for review and approval.
d) Stacked Events
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 independently 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 most planted in Colombia.
e) Additional Requirements
There are no additional requirements at this time.
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 biotechnology and non-biotechnology crops in compliance with ICA resolution 682 of 2009 for cotton and 2894 of 2010 for corn. Both resolutions also require a 300 meter (984 feet) planting distance between GE and non-GE crops.
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 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 2014. 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 concerns that 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 being justified under “consumer-right-to-know” principles.
h) Trade Barriers
Although there are no trade barriers at this time, the resolution of a reasonable LLP policy is essential to maintain trade flow.
i) Intellectual Property Rights
Regarding intellectual property rights (IPR), Colombia follows the guidelines provided as a member of the following groups: the Convention for the Protection of Industrial Property, the General Agreement on Tariffs and Trade (GATT), the International Union for the Protection of New Plant Varieties (UPOV), the G3 Mexico, Colombia and Venezuela Agreement, 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).
j) Cartagena Protocol Ratification
As a signatory (and ostensibly host) to the CPB, Colombia approved the Biosafety Protocol through Law 740 in 2002 and implemented in September 2003. To date, the regulations to implement the CPB and 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 February1, 2007; and, MEHTD resolution 957 of May 19, 2010.
k) International Treaties/Fora
Colombia plays an active role in the discussions of the CPB Conference of the Parties as a signatory. In addition to CPB meeting, 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.
l) Related Issues
None at this time.
m) Monitoring and Testing
In 2009, the GOC issued resolution 682 requiring GE seed companies to adopt a life cycle stewardship approach to guide producers, but specifically for GE cotton production. In September 2012, a resolution was issued for handling GE corn, outlining the regulatory expectations for farmers and GE seed companies. Both resolutions established a production and commercial road map for the two most widely grown GE crops in Colombia. Regarding testing, INVIMA is actively conducting port of entry testing at GOC laboratories to assess imported GE commodities destined as raw material for food and feed and the potential for unapproved events in shipments, or “asynchronous approvals”. To date, there have been no detections of unapproved events in shipments.
n) Low Level Presence
The Technical Annex will supplement Resolution 4254 and require that GE event imports intended for human consumption be approved. Considering the lengthy timeframe that Colombian regulatory officials take to review and approve new GE events, the GOC has proposed a 5 percent LLP threshold to address asynchronous approvals; however, the Annex is under domestic comments until June 30. After the comment period closes, the Annex will be submitted for international comments for an additional two months. The final draft of the Technical Annex may be issued in late 2014. The LLP threshold will only apply to food use GE events and not for GE raw materials destined for animal feed.
IV: Plant Biotechnology Marketing Issues
a) Market Acceptance
Biotechnology derived commodities have been in use in Colombia for the last 14 years. Most press coverage is favorable and to date, consumers have not voiced major concerns about GE products or products containing GE raw materials. The GOC's structure for biotechnology regulations is science-based for accepting or rejecting new biotechnology events. The basic principle of the GOC 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. In addition, some indigenous groups have been inspired by non-governmental organizations (NGOs) to oppose the introduction GE crops for planting based on biodiversity concerns.
b) Public/Private Opinions
Although Colombia's approach to biotechnology has been favorable, some environmental NGOs are pressuring government officials to reject biotech-derived technologies. In fact, anti-biotech activists targeted a seed regulation, ICA resolution 970, which establishes requirements for production, imports, exports, storage, trade and use of seeds in Colombia. The activists began a campaign of misinformation about the regulation and the use of biotech-derived seeds, stating that the resolution restricts seed access and forces farmers to buy expensive GE seed from multinational corporations.
c) Marketing Studies
A preliminary IFPRI study (Zambrano et al. 2011) on the benefits of biotech cotton for women indicates that it saved them time and money. The study focused on women farmers, an important stakeholder that needs more detailed study in Colombia. The study helped highlight the role of women as practitioners and beneficiaries of biotech cotton production. (Excerpt form: James, Clive, 2011. Global Status of Commercialized Biotech/GM Crops: 2011. ISAAA Brief No. 43. ISAAAA: Ithaca, New York).
V: Plant Biotechnology Capacity Building and Outreach
FAS/Bogota has been working together with different industry groups to disseminate information on the benefits of biotechnology and collaborating on the following activities:
• August 2012: FAS collaborated with the U.S. Grains Council (USGC) to send a delegation of industry representatives and GOC regulatory officials in charge of implementing labeling laws per resolution 4254 for GE products to attend a week-long program in Washington, D.C. and New Orleans;
• February 2013: First Colombian Borlaug fellow from the National Rice Producers Association attended a four month biotechnology program at the University of Georgia;
• April 2013: FAS collaborated with the USGC to organize a delegation of GOC regulatory officials and industry representatives to Washington, DC and St. Louis for discussions on LLP policies and trade impacts;
• June 2013: FAS collaborated with the USGC and the Colombian National Industries Association to conduct a two day seminar on LLP policies and the Mexico experience with a zero tolerance LLP policy and impacts on grain trade;
• September 2013: FAS and Department of State partnered with the USGC to conduct a LLP seminar for government officials, private sector representatives and academia with the purpose of highlighting different LLP approaches in Spain and Argentina.
• September 2013: FAS collaborated with the USGC to sponsor a team of three GOC regulatory officials to attend the Global LLP Initiative meeting in Durban, South Africa, in order to introduce proposed LLP policies in Colombia.
• March 2014: FAS collaborated with the USGC to conduct technical meetings with GOC officials responsible for drafting LLP policy.
b) Strategies and Needs
Colombia would greatly benefit with more aggressive educational efforts on biotechnology issues. Therefore, FAS/Bogota would like to continue working with appropriate U.S. government agencies to develop projects and programs that strengthen biotechnology knowledge and understanding. Some activities may include:
• GOC attendance at LLP workshops and the Global LLP Initiative would assist GOC officials in making final decisions on LLP policy;
• GOC attendance at the CBP COP/MOP meetings in October 2014;
• Conduct media outreach program to generate knowledge and understanding ensuring a positive operational environment for the seed industry that is directly involved with addressing GE seed intellectual property;
• Educational programs for GOC officials and researchers through Cochran and Borlaug will continue to strengthen biotechnology knowledge and understanding.
VI: Animal Biotechnology
a) Product Development
According to GOC officials, there has been some research initiatives conducted by universities on animal biotechnology. However, increased costs for this technology seem to be a key factor in discouraging its adoption. Aquaculture and could be a possible area of animal biotechnology research in the long term, in addition to GE cattle, but cost of research could be a deterrent.
b) Commercial Production
Colombia has focused on importing recombinant vaccines and diagnostic kits for animal diseases.
VII. Animal Biotechnology Policy:
The GOC established a regulatory framework for plant biotechnology that also applies to animal biotechnology. Per Decree 4525, the CTN-Bio is the interagency committee responsible for the evaluation and approval of GE animal products once ICA has conducted a risk evaluation.
b) Labeling and Traceability
Refer to Section III
c) Trade Barriers
No trade barriers have been identified at this time.
d) Intellectual Property Rights (IPR)
No IPR regulation has been identified at this time.
e) International Treaties/Fora
Colombia is a signatory to the CPB and a member country to the World Trade Organization, International Organization for Animal Health and the Codex Alimentarius Commission. ICA is the focal point on animal biotechnology issues.
VIII. Animal Biotechnology Marketing
a), b) Market Acceptance, Public/Private Opinions
Public knowledge of biotechnology is mostly related to plants. Animal biotechnology is not well known and receives little media attention. Animal biotechnology is mostly related to assisted reproductive technologies.
c) Market Studies
None at this time
IX. Animal Biotechnology Capacity Building and Outreach
Government officials will benefit from risk evaluation training at FDA's Center for Veterinary Medicine, primarily because every single GE event must be submitted to the Risk Unit at ICA prior to an assessment by CTN-Bio.
b) Strategies and Needs
Colombia has done limited work on animal biotechnology. Therefore, any training and attendance to seminars and workshops would be of interest to GOC officials. Some activities that may help this purpose include:
• Attendance to the animal biotechnology seminar in Brazil;
• Educational programs for GOC officials and researchers through Cochran and Borlaug