Colombia Remains Open To New Technologies Nov. 17, 2016
Colombia remains open to the adoption of biotech-derived commodities. However, area planted of genetically engineered (GE) corn and cotton decreased this past year due to high production costs and lower international prices. The Constitutional Court ruled in favor of mandatory labeling of GE organisms in response to a lawsuit.
Section I. Executive Summary:
Colombia is generally open to biotechnology. However, pending labeling legislation, as well as synchronicity issues that result from a fragmented internal approval process are causing 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 2015, trade values were above $2.4 billion. U.S. exports in GE derived agricultural products such as corn, cotton, soybeans, soybean meal, soybean oil, and distillers' grains were valued at $1.3 billion in 2015.
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 were published to outline specific requirements and procedures for approving and using GE agriculture and derived products in Colombia. Colombia's biotechnology regulations are regularly reviewed and modified, providing opportunities to engage GOC regulatory agencies with technical outreach that facilitates the adoption of science-based regulatory policies.
The GOC has created three technical biotechnology committees to analyze environmental, biosafety and food safety impacts of biotech-derived products. The MHSP issued Resolution 4254 establishing the requirements for labeling of foods derived from modern biotechnology. The resolution was implemented in June 2012. In addition, the GOC developed the Technical Annex to supplement resolution 4254, but internal GOC deliberations continue, and this has yet to be implemented In the meantime, on September 8, 2015, the Constitutional Court ruled in favor of mandatory labeling of GE organisms in response to a lawsuit attacking Consumer Law 1480, Article 24, which refers to labeling, but does not address GE labeling.
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 and GE corn continues to surpass GE cotton adoption with area planted of 85,251 hectares in 2015. 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 animal biotechnology, Colombia continues to import GE vaccines for animal diseases. In addition, there seems to be an increased interest from overseas companies on accessing the Colombian market with GE mosquitoes.
Section II. Plant and Animal Biotechnology
CHAPTER I: 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, cassava and grass. 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. 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. 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 for solely export markets. Total area planted for these ornamental crops is 12 hectares. In 2015, Colombia planted 85,251 and 15,868 hectares of GE corn and cotton, respectively. Although GE corn planting decreased by 3,797, it continues to be the most widespread GE plant cultivated in Colombia . It represents 24% of the total area planted to corn. GE cotton area planted decreased dramatically by about 13,970 hectares. However, this was part of an overall decrease in cotton plantings, and GE crops still represent 77% of total area planted. GE technology continues to be adopted, but high production costs and lower international prices have discouraged greater adoption by farmers country wide.
In addition to the above-mentioned GE events, there are pending applications for several other crops that are in varying phases of approval
Genetically engineered Dutch blue carnations are produced under greenhouse conditions for export to Europe and GE blue petal roses for exports to Japan. Area planted in 2015 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 $40-$50.
Genetically engineered seeds are imported mostly form the United States and occasionally from South Africa, Argentina and Australia.
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 labeling requirements have the potential to destabilize Colombia's regulatory environment for GE products and to squander benefits for consumers and the agricultural sector.
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);
- MHSP 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.
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.
National Committee for Health and Human Nutrition (CTN-Health):CTN-Health's function is to assess the impact 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 approvals is extensive. Colombian industry and the U.S. Government are requesting that the Ministry streamline the approval procedures with predictable timelines. The graph below illustrates the CTN-Health approval process.
National Technical Committee for Environment (CTN-Environment):This committee's function is to assess GE events that may impact the environment. 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:
All GE events for commercial cultivation and/or environmental release must be approved by the GOC. All GE events must be approved individually and there is no process to review “stacked" events as a whole. 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.
c) 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. Stacked events (resistant to some lepidopteran pests and tolerant to Roundup herbicide) continue to be the most popular GE plant products cultivated in Colombia.
d) Field Testing
Colombia allows for field-testing for GE crop cultivation after a risk assessment is submitted to CTN-Bio for review and subsequent approval.
e) Innovative Biotechnologies
Both academia and research centers have initiated some discussions around innovative technologies. The major challenge is for government officials to decide how these technologies may be regulated and if they should be covered by existing domestic legislation and regulation, or whether they should be considered under the GE umbrella.
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.
There is some degree of uncertainty regarding the impact that GE labeling 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 labeling of food derived from modern biotechnology in 2012. The resolution requires labeling information for product health and safety, such as potential allergenicity. Labeling must also address the functionality of the food, as well as the identification of significant differences in the essential characteristics of the food. In addition to Resolution 4254, the Colombian government drafted a Technical Annex to supplement the Resolution, but the Annex is still in internal discussion within the MHSP. There remains no indication when the Annex will be finalized and published/notified.
In the meantime, on September 8, 2015, the Constitutional Court ruled in favor of mandatory labeling of GE organisms in response to a lawsuit attacking Consumer Law 1480, Article 24, which refers to labeling, but does not address GE labeling. According to this decision, Congress is required to draft and implement legislation on mandatory labeling of GE organisms within two years to comply with the court's ruling. As of now, GE labeling relies on Resolution 4254. However, challenges may rise once Congress seeks to comply with the Court's ruling late in 2017.
Regarding labeling 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 labeled 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. Regarding testing, INVIMA is actively conducting port of entry testing at MHSP 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.
i) Low Level Presence (LLP)
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. The Annex will provide a LLP threshold to address that concern. The Technical Annex will supplement regulatory Resolution 4254 and require approval for all GE derived agricultural imports destined for human consumption. Considering the unpredictable and lengthy timeframe for GE approvals, the GOC has proposed a 5 percent LLP threshold to address asynchronous approvals. The Annex, however, remains in internal discussion/review. After finalizing the Annex internally, the MHSP 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.
j) Additional Regulatory Requirements
There are no additional requirements at this time
k) 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 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 February1, 2007; and, MEHTD resolution 957 of May 19, 2010.
m) International Treaties/Fora
Colombia plays an active role in the discussions of the CPB Conference of the Parties as a signatory. In addition to the CPB, 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. Most recently, Colombia joined the Global Low Level Presence Initiative to develop international approaches to manage LLP.
n) Related Issues
PART C: Marketing
a) 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 have pushed for mandatory GE labeling as well as other regulations, such as Decree 4525, which establishes three interagency committees responsible for biosafety issues and the evaluation and approval of biotech events, to destabilize the regulatory framework.
b) Market Acceptance/Studies
Biotechnology derived commodities have been used in Colombia for about 15 years. Public opinion and media coverage to date has been favorable 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 GE crops for cultivation and environmental release based on biodiversity concerns. Regarding biotechnology related studies, an IFPRI study 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.
CHAPTER II: ANIMAL BIOTECHNOLOGY
PART D: Production
a) Product Development
According to GOC officials, there have been some research initiatives by universities on animal biotechnology. However, the high costs of this technology seem to be a key factor in discouraging more widespread adoption. Aquaculture could be a possible area for more animal biotechnology research, in addition to GE cattle, but funding will likely be the primary constraint.
b) Commercial Production None.
Colombia has focused on importing recombinant vaccines and diagnostic kits for animal diseases. Most recently, a company expressed interest in accessing the Colombian market with GE mosquitoes to control harmful insect populations. The technology will combat the Aedes aegypti, which is a vector of dengue, Zika, chikungunya, yellow fever and other arboviruses and will also assist with crop protection, specifically with medfly, as Colombian fruit exports are being badly hurt by damage from the pest.
PART E: Policy
The GOC regulatory framework for plant biotechnology 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 after a risk evaluation is conducted by ICA. Intellectual Property Rights (IPR). No IPR regulation has been identified at this time.
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 point of contact on animal biotechnology issues.
PART F: Marketing
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.