Colombia remains open to the adoption of biotech-derived commodities and innovative technologies. While area planted to GE (genetically engineered) corn decreased in response to an overall decrease in corn, there was slight recovery in cotton plantings. Colombia recently approved commercial plantings of the first domestically developed corn genotype containing the TC-1507 off-patent event. The Colombian government and stakeholders have to finalize discussions on biotechnology regulations regarding low-level presence (LLP), GE labelling, and GE seeds to stabilize Colombia’s regulatory environment for GE products.
Section I. Executive Summary
Colombia is generally open to biotechnology. However, labelling, GE seed proposed banning and approval synchronicity issues, as well as internal discussions around key biotechnology regulations are causing some regulatory uncertainty, and potentially hindering the adoption of new technologies.
The implementation of the U.S.-Colombia Trade Promotion Agreement (CTPA) propelled Colombia to become the second largest market in Latin American for U.S. agricultural exports. In 2018, trade values were above USD 2.9 billion. U.S. exports in GE derived agricultural products such as corn, cotton, soybeans, soybean meal, soybean oil, and distillers’ grains were valued at USD 1.8 billion in 2018.
Parts of the Colombian agricultural biotechnology regulatory framework remain under review by the Government of Colombia (GOC). Colombia approved the Cartagena Protocol on Biosafety (CPB) in 2002. In 2005, Decree 4525 was published to implement the CBP. Since then, several other GOC regulatory measures have been published to outline specific requirements and procedures for approving and using GE agricultural and derived products in Colombia. Colombia’s biotechnology regulations are reviewed and modified, providing opportunities to engage GOC regulatory agencies with technical outreach that facilitates the adoption of science-based regulatory policies, especially on low-level presence (LLP), labelling and innovative technologies. Regarding the latter, the GOC issued Resolution 29299 for crops obtained through the use of innovative technologies to determine if the cultivar corresponds to a living modified organism or a conventional organism.
The GOC has created three technical biotechnology committees to analyse environmental, biosafety and food safety impacts of biotech-derived products (See Part B, Policy). The Ministry of Health and Social Protection (MHSP) issued Resolution 4254 establishing the requirements for labelling of foods derived from modern biotechnology. The resolution was implemented in June 2012. In addition, the GOC has been working on establishing a LLP threshold policy for five years, but internal deliberations continue. In the meantime, on September 8, 2015, the Constitutional Court ruled in favor of mandatory labelling of GE organisms in response to a lawsuit attacking Consumer Law 1480, Article 24, which refers to labelling, but does not address GE labelling. Despite the two-year deadline to develop mandatory labelling regulations, the GOC has not produced final rules, but the issue is currently being revisited.
In 2002, GE cotton was the first GE plant cultivated on a non-restricted commercial basis in Colombia. The first GE corn traits were approved in 2007. Although GE corn continues to surpass GE cotton area planted with 76014 hectares in 2018, GE cotton area planted showed a 33 % recovery. GE cotton represents 90 percent of total area planted while GE corn represents 19 % of total area planted.
Also, GE Dutch blue carnations continue to be produced under greenhouse conditions for export to Europe, and GE blue petal roses for exports to Japan. Regarding domestic GE event development, Colombia recently approved commercial plantings of the first GE off patent corn event on August, 2019.
CHAPTER 1: PLANT BIOTECHNOLOGY
PART A: Production and Trade
a) Product Development
Colombia had not developed any biotechnology crops to date. However, on August 2019, the Colombian Agricultural Institute (ICA), authorized the Colombian Grain Producers Association (Fenalce) to begin commercial plantings of their recently developed corn genotype containing the TC- 1507 off-patent event in the humid Caribbean region, Cauca and Magdalena river valleys, as well as in the Eastern plains and the Coffee region.
There are other Colombian organizations conducting specific research projects. The Colombian sugar cane research centre (CENICAÑA) is developing a sugar cane variety resistant to the yellow leaf virus. The International Center for Tropical Agriculture (CIAT) is researching GE rice, cassava and grass. EAFIT university is working on sacha inchi and castor bean oleic content. 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 lepidopterous insects. Colombian universities and research institutes are working together to develop rice and potato biotechnology events. 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. 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 cultivated solely for export markets. Total area planted for these ornamental crops is 12 hectares. In 2018, Colombia planted 76,014 and 12,103 hectares of GE corn and cotton, respectively. Although Colombian farmers continue to adopt GE technology , there was an overall decrease in corn plantings (GE and non-GE) as domestic corn prices are highly affected by international prices and high production costs given that imports supply 80 percent of the domestic market. In fact, GE corn planted decreased by 10,016 hectares. Regarding cotton, GE area planted increased by 3,028 hectares. Bolivar, Cundinamarca, La Guajira and Sucre resumed planting GE cotton as there is increased optimism due to favorable domestic prices (See Charts 1, 2, and 3).
In addition to the above-mentioned GE events, there are pending applications for several other crops that are in varying phases of approval (See appendices A and B).
Genetically engineered Dutch blue carnations are produced under greenhouse conditions for export to Europe and GE blue petal roses for export to Japan. Area planted in 2018 for both Dutch blue carnations and blue petal roses remains unchanged at 12 hectares. One blue petal rose in the Japanese retail market has an estimated value of about USD 40- USD 50.
Genetically engineered corn seeds are imported mostly from Brazil (1,767 tons) and Honduras (554 tons). Genetically engineered cotton seeds are imported from the Unites States (41.4 kg). Regarding crops, Colombia imported GE derived agricultural products such as corn, cotton, soybeans, soybean meal, soybean oil, and distillers’ grains valued at $1.8 billion in 2018 from the United States, mainly.
e) Food Aid
Colombia receives limited food aid from the United States. Any food aid containing GE events must have regulatory approval in Colombia for human consumption.
f) Trade Barriers
Pending mandatory labelling requirements, the lack of a LLP policy, (see PART B, Section g and i, for additional information), and the recent initiative to ban GE crop seeds have the potential to destabilize Colombia’s regulatory environment for GE products and to squander benefits for consumers and the agricultural sector. On September 10, 2019, a law project was submitted before Congress to amend Article 81, under the Colombian Constitution, and include a paragraph banning GE crop seed imports, exports, production and commercialization with the purpose of protecting the environment and guarantying farmers’ free access to seeds. The initiative passed through first debate and it is expected to be scheduled for second debate. Pro-biotechnology stakeholders are pushing to table the proposed bill.
PART B: Policy
a) Regulatory Framework
The following Ministries are involved in the regulation of agricultural biotechnology production and imports:
• Ministry of the Environment, Housing and Territorial Development (MEHTD);
• Ministry of Health and Social Protection (MHSP);
• Ministry of Agriculture and Rural Development (MARD), through the Colombian Agricultural Institute (ICA);
• Colciencias (Colombian Science and Technology Agency);
• National Institute for the Surveillance of Food and Medicines (INVIMA)
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. These committees are:
The National Technical Committee for Agriculture, Fishery, Forestry and Agro-industry (CTN- Bio): CTN-Bio’s role is to assess GE events for non-food related GE products. 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 a risk assessment varies since all dissenting concerns by the different ministries must be resolved before a product is approved. The graph below illustrates the CTN-Bio approval process:
The National Technical Committee for Environment (CTN-Environment): This committee’s function is to assess GE events that may impact the environment only, which is the case of bioremediation. CTN-Environment has yet to receive any requests for review of GE events. However, in May 2010, the MEHTD issued regulatory Resolution 957 establishing procedures on the information companies must submit for evaluation and the Ministry’s procedures of assessing GE events. The graph below illustrates the CTN-Environment approval process:
The National Committee for Health and Human Nutrition (CTN-Health): CTN-Health’s function is to assess the impact of GE products and by-products on human health. On February 1, 2007 the MHSP issued regulatory Resolution 227 to establish the functions of the committee. CTN-Health has submitted a number of recommendations for approval to the MHSP; however, the timeline for issuing approval regulatory resolutions has been extensive, over 1.5 years. On July 19, 2017, the MHSP issued resolution 2535, transferring the responsibility of issuing approval regulatory resolutions to INVIMA, which has started to streamline the approval procedures with more predictable timelines. The graph below illustrates the CTN-Health approval process:
All GE events for commercial cultivation and/or environmental release, food consumption and animal feed must be approved by the GOC. The approval process for GE derived feed and food materials are completed by CTN-Bio and CTN-Health, and the committees’ decision timelines are not coordinated. These parallel timelines can result in internal asynchronous approvals (see appendix B). Regarding stacked events, all GE events must be approved individually and there is no official process to review “stacked” events as a whole. Regarding approval expiration, food GE events will have to be resubmitted for approval, once more, after the 10-year expiration deadline. Under current submission guidelines INVIMA has not included any additional requirements after the initial expiration renewal.
c) Stacked Events or Pyramided Event Approvals
Even though the individual events may have already been approved, the “stacked” variety must independently go through the approval process. However, starting August, 2017, the CTN-Health established an internal, yet unofficial, procedure to facilitate the approval process for stacked events when their single events have already been approved, which has reduced the current approval timeframe and alleviated asynchronous approvals between exporting and importing countries
d) Field Testing
Colombia requires field-testing for GE crop cultivation (see appendix A) after a risk assessment is submitted to CTN-Bio for review and subsequent approval. The testing is required for each of the agro ecological regions where the event is to be planted which slows the review as Colombia has six regions.
e) Innovative Biotechnologies
There are currently three research groups working on genome editing. The CIAT Research Center is focused on herbicide tolerant cassava, increased rice yields, viruses and bacteria resistant rice, high-zinc and iron rice, bean nutritional quality, and cacao cadmium absorption. Agrosavia is working on potato with reduced toxins and phosphorus altered rice. The EAFIT university is doing research on castor bean oleic content. Regarding regulations, ICA issued resolution 29299 to determine if the cultivar corresponds to a living modified organism or a conventional organism. The interested party submits and application to ICA for review and within a period of sixty (60) business days, if no further information is required, ICA will determine whether the new cultivar is considered GE or not and, therefore, it is within or beyond the scope of regulation for GE. If is considered to be GE, the cultivar will have to go through the existing regulatory GE framework. Otherwise, it will be treated under existing conventional crop legislation and regulation. ICA is currently reviewing two applications under current GE regulation: waxy corn modified for altered starch composition and phosphorus altered rice, with decreased phosphorus in the grains, but increased levels in the leaves.
ICA has carried out an evaluation of cross-pollination and found that both GE and non-GE crops do coexist without posing additional risks to non-GE crops. Regardless, farmers actively apply the practice of buffer zones or a natural barrier of fallow terrain in compliance with ICA resolution 682 of 2009 for cotton, which establishes a buffer zone following the 80/20 or 96/4 scheme and 2894 of 2010 for corn, which establishes a 90/10 scheme. (See Chart 4). Both resolutions also require a 300 meter (984 feet) planting distance between GE and non-GE crops.
g) Labelling and Traceability
There is some degree of uncertainty regarding the impact that GE labelling will have on the current GE regulatory framework, and on the use of GE technology in Colombia. The MHSP issued regulatory Resolution 4254 establishing the requirements for labelling of food derived from modern biotechnology in 2012. The resolution requires labelling information for product health and safety, such as potential allergenicity. Labelling must also address the functionality of the food, as well as the identification of significant differences in the essential characteristics of the food.
In the meantime, on September 8, 2015, the Constitutional Court ruled in favour of mandatory labelling of GE organisms in response to a lawsuit attacking Consumer Law 1480, Article 24, which refers to labelling, but does not address GE labelling. According to this decision, Congress was required to draft and implement legislation on mandatory labelling of GE organisms within two years to comply with the court’s ruling. Despite the two-year deadline, no final rules have been produced. However, on August 14, 2019 a law project was submitted revisiting the 2015 Constitutional Court’s ruling and this has the potential to destabilize Colombia’s GE labelling regulatory environment depending on how eventual mandatory labelling may be approached. As of now, GE labelling relies on Resolution 4254.
As per resolution 4254, the use of statements such as “GMO free” or “do not contain GMO” is not accepted, unless the manufacturer demonstrates and sustains that the claim is truthful and not misleading. Importers have to provide proof through laboratory results that products are GMO free, creating considerable issues due to difficulties in lab results availability as producers do not seem to have those results available for importers who, in turn, have to get a third party to test products and provide lab results. As per INVIMA communication 4000-3988-19, the requirement may be exempted only when the main ingredients are not included in the list of GE foods attached to the communication. An increased number of imported packaged products entering the Colombian market now bear the “Non GMO Project Verified” or the “Non-GMO/GE Process Verified” legends, which, as per current regulation, are perceived as equivalent to “GMO- free” claims. Therefore, manufacturer/importers must provide a supplementary label clarifying what the scope of the legend is to be able to commercialize their products as per INVIMA communication 4000-1071-18.
Regarding labelling for imported GE materials (seeds or other plant reproductive materials and animal products), ICA issued regulatory Resolution 946, stating that imported GE derived materials should be identified as “Genetically Modified Organisms” or, in Spanish, Organismo Modificado Geneticamente. This requirement is being justified under “consumer-right-to-know” principles.
h) Monitoring and Testing
In 2009, the GOC issued regulatory Resolution 682 requiring GE seed companies to adopt a life cycle stewardship approach to guide producers, specifically targeting 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. During the first semester of 2018, the Colombian Association of Agricultural Biotechnology (Agro-Bio) released MARI, an insect resistance management program to encourage producers in implementing good agricultural practices that may assist in insect resistance mitigation. Regarding testing, INVIMA is actively conducting port of entry testing at INVIMA laboratories to assess imported GE commodities destined as raw material for food and feed and the potential for asynchronous, unapproved events in shipments. To date, there have been no detections of unapproved events. As for packaged products, INVIMA is also monitoring products that have “Non GMO Project Verified,” “Non-GMO/GE Process Verified” and “Non-GMO” claims requesting importers to support claims through laboratory results to be able to commercialize them. See Part B, section g for additional information on labeling and testing.
i) Low Level Presence (LLP) Policy
Industry and commodity exporters have expressed concerns that not all GE events traded in international commerce have been approved in Colombia. This could potentially delay shipments as a result of asynchronous approvals. Considering the unpredictable and lengthy timeframe for GE approvals, the GOC initially proposed a five percent LLP threshold. Although Ministry of Health officials have indicated that they are planning to present a draft LLP policy to the Ministry of Commerce, Industry and Trade (MinCIT) and the Ministry of Agriculture for their consideration and feedback, no progress has been made. After finalizing the draft policy internally, the Ministry of Health will submit the regulatory policy for international comments for two months. The LLP threshold will only apply to food-use GE events and not for GE raw materials destined for animal feed. Once the LLP policy for food-use GE events is issued, it is expected that GOC will follow with the one for GE animal feed.
j) Additional Regulatory Requirements
There are no additional requirements at this time.
k) Intellectual Property Rights (IPR)
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 regulatory Decision 351, Common Provisions on the Protection of the Rights of Breeders of New Plant Varieties, and regulatory Decision 391, Common Regime on Access to Genetic Resources (Hodson & Carrizosa, 2007).
l) Cartagena Protocol Ratification
As a signatory (and ostensibly the host) to the CPB, Colombia approved the Biosafety Protocol through Law 740 in 2002. 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 February 1, 2007; and, MEHTD resolution 957 of May 19,2010.
m) International Treaties and Forums
Colombia plays an active role in the discussions of the Nagoya-Kuala Lumpur Protocol on redress and liability and the CPB Conference of the Parties, as a signatory. In addition, 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. In 2017, Colombia joined the Global Low Level Presence Initiative to develop international approaches to manage LLP.
n) Related Issues
On March 2017, the Minister of Agriculture presented Congress with a draft law that creates the National System for Agricultural Innovation (SNIA). SNIA calls for the establishment of a Council for Agricultural Innovation to advise on biosafety, intellectual property and genetic resource regulations as outlined in the Peace Accord signed with the Revolutionary Armed Forces of Colombia on December 2016. On December 29, 2017, Law 876 was approved and it is unknown on the impact it may have on existing and proposed biotechnology regulations.
PART C: Marketing
a) Public/Private Opinions
Although Colombia’s approach to biotechnology has been favourable, some environmental NGOs are pressuring government officials to reject biotech-derived technologies. In fact, anti-biotech activists have pushed for mandatory GE labeling as well as GM seed ban. See Part B, section g for additional information on labeling. See part A, section f for additional information on trade barriers.
b) Market Acceptance/Studies
Biotechnology derived commodities have been used in Colombia for 19 years. Public opinion and media coverage to date has been favourable of biotechnology and consumers have not voiced major concerns about products containing GE derived raw materials. The GOC’s structure for biotechnology regulations is science-based for approving or rejecting new biotechnology events. The basic principle of the GOC is to adopt the technologies that may help the economic/social development of rural Colombia. Of the various ministries, the MEHTD has been the most critical of biotechnology approvals. In addition, some indigenous groups have been inspired by non-governmental organizations NGOs to oppose the introduction of GE crops for cultivation and environmental release based on biodiversity concerns. As per current regulations, indigenous territories are GE-free zones.
Regarding biotechnology related studies, an IFPRI study (Zambrano et al. 2011) on the economic benefits of cultivating GE cotton for women farmers indicated that they saved both time and money. The study helped highlight the role of women as practitioners and beneficiaries of biotech cotton production. In 2016, the Colombian Association of Agricultural Biotechnology (Agro-Bio) released a study showing biotechnology as a valuable tool for farmers focusing on the benefits for GE crops in Colombia from 2003 to 2015 and the potential they may have on rural development and self-sufficient agriculture.