Report Highlights:

The production of biotech-derived commodities continues to expand. Area planted of genetically engineered (GE) corn has surpassed GE cotton. The Government of Colombia (GOC) Ministry of Health and Social Protection (MHSP) continues with internal deliberations of a biotechnology regulatory framework called the "Technical Annex". The Annex primarily establishes labeling requirements for foods with GE ingredients and the identification of raw materials through a low level presence (LLP) threshold.

Executive Summary:

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 2014, trade values were slightly 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 2014.

The Colombian agricultural biotechnology regulatory framework, or "Technical Annex", remains under review by the 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 counterparts 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.

In 2002, GE cotton was the first GE 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 89,000 hectares in 2014. 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.

Plant Biotechnology

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 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 2014, Colombia planted 89,000 and 29,000 hectares of GE corn and cotton, respectively. GE corn planting increased dramatically by almost 14,000 hectares, becoming the most widespread GE plant cultivated in Colombia. GE cotton area planted increased by about 3,000 hectares, a considerable recovery after two years of decline.

In addition to the above-mentioned GE events, there are pending applications for several other crops that are in varying phases of approval.

c) Exports

GE Dutch blue carnations are produced under greenhouse conditions for export to Europe and GE blue petal roses for exports to Japan. Area planted in 2014 for both Dutch blue carnations and blue petal 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.

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.

b) Approvals

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) 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.

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. Stacked events (resistant to some lepidopteran pests and tolerant to Roundup herbicide) continue to be the most popular GE plant products cultivated in Colombia.

e) Additional Requirements

There are no additional requirements at this time.

f) Coexistence

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.

g) Labeling

The MHSP issued regulatory Resolution 4254 establishing the requirements for labeling of food derived from modern biotechnology. The resolution requires labeling information for product health and safety, such as potential allergenicity. Labeling must also address functionality or the use 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 is deliberating the Technical Annex to supplement the Resolution, but the Annex is in internal discussion within the MHSP. There remains no indication when the Annex will be finalized and published/notified. Agricultural traders and food industries that deal with biotech-derived commodities will be required to comply with the new Annex requirements to ensure shipments for human consumption entering Colombia received regulatory approval. 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. 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) Trade Barriers

Although there are no trade barriers at this time, a practical LLP policy will be essential to maintain the flow of trade.

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 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).

j) 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.

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 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.

l) Related Issues

None.

m) 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.

n) Low Level Presence

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.

Plant Biotechnology Marketing Issues

a) Market Acceptance

Biotechnology derived commodities have been used in Colombia for about 14 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.

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 regulatory Resolution 970, which establishes requirements for production, imports, exports, storage, trade and use of seeds in Colombia. The activists conducted a campaign of misinformation about the regulation and use of biotech-derived seeds, incorrectly informing the public that the Resolution restricts seed use and forces farmers to buy expensive GE agricultural seed from multinational corporations.

c) Marketing 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.

Plant Biotechnology Capacity Building and Outreach

a) Activities

FAS/Bogota has been working together with different industry groups to disseminate information on the benefits of biotechnology and collaborating on the following activities:

  • 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 U.S. Grains Council (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, including the Mexico experience with a zero tolerance LLP policy and the impacts on GE corn trade;
  • September 2013: FAS and the Department of State (DOS) 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.
  • August 2014: FAS sponsored a delegation of GOC regulatory officials to attend the second international workshop for the regulation of animal biotechnology in Brasilia, Brazil.
  • September 2014: FAS partnered with the DOS and the Colombian biotechnology advocacy organization, Agro-Bio, to conduct a four-day outreach event in five regional departments of Colombia.
  • September 2014: FAS and the USGC collaborated with the GOC to participate in the 7th Meeting of Parties to the CPB in Pyeongchang, Korea.

b) Strategies and Needs

Colombia would greatly benefit with more educational efforts on the benefits of agricultural biotechnology. FAS/Bogota will continue to work with the appropriate U.S. government agencies and non-government stakeholders to develop programs that strengthen biotechnology knowledge and understanding. Some activities may include:

  • Conduct outreach programs that improve the public knowledge and understanding of agricultural biotechnology on GE seed and intellectual property;
  • Apply Cochran and Borlaug Fellowships and other educational programs to support improving the understanding of GOC officials on the latest policy and commercial trends for agricultural biotechnology.

Animal Biotechnology

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

c) Exports

None

d) Imports

Colombia has focused on importing recombinant vaccines and diagnostic kits for animal diseases.

Animal Biotechnology Policy:

a) Regulation

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.

b) Labeling and Traceability

c) Trade Barriers

None.

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 point of contact on animal biotechnology issues.

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.

Animal Biotechnology Capacity Building and Outreach

a) Activities

The GOC could benefit from further risk evaluation training at FDA's Center for Veterinary Medicine. This is critical given each GE event must be submitted to the ICA Risk Unit prior to an assessment by CTN-Bio. Additional training could improve the efficiency of risk evaluations and regulatory decision-making.

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:

  • Animal biotechnology educational programs for GOC officials and researchers through the Cochran and Borlaug Fellowships and other policy and research collaboration.