Highlights

In Nicaragua, imports of Genetically Engineered crops (GE) are limited to the use of animal feed since the Nicaraguan Commission of Risk Analysis of Living Modified Crops (CONARGEM) has not yet approved the use of GE crops for human consumption and/or cultivation. GE corn and processed GE grains, such soybean meal, are the top imported products. The lack of an operational legal framework continues to be a big limitation to promote the adoption of new biotechnologies. The Nicaraguan market is new to the concept of GE technologies but the private sector is interested in increasing the number of approved biotech events, particularly for corn cultivation.

Section I. Executive Summary

Nicaragua is a signatory of the Cartagena protocol on biosafety and requires notification for imports of Genetically Engineered crops (GE) and a risk analysis for biotech events. Imports of GE crops are limited to the use of animal feed since the Nicaraguan Commission of Risk Analysis of Living Modified Crops (CONARGEM) has not yet approved the use of GE crops for human consumption and/or cultivation. GE corn and soybean meal are the top imported products. In 2015, Nicaraguan imports of these two products reached over 288,707 MT with a total value of $87 million. Importers and/or exporters cannot request approval for new GE events since Nicaragua's biotech law, Law 705, lacks implementing regulations causing a major limitation in the adoption of new biotechnologies in Nicaragua. Some of the best prospects during the mid-term could be the approval of GE corn and soybean events for cultivation to be used in animal feeds. However, the approval of GE events will depend, to a great extent, on whether the implementing regulations of Law 705 are officially passed.

Section II. Author Defined:

CHAPTER 1: PLANT BIOTECHNOLOGY

PART A: PRODUCTION AND TRADE

PRODUCT DEVELOPMENT: Nicaragua has not developed any genetically engineered (GE) crops.

COMMERCIAL PRODUCTION:There is no commercial production of GE crops in Nicaragua.

EXPORTS: Nicaragua does not export GE crops to the United States or other countries.

IMPORTS: Nicaragua imports genetically engineered (GE) corn and GE soybean meal for the animal feed industry. In 2015, Nicaraguan imports of yellow corn from the United States reached 177,889 metric tons (MT) with a total value of $38 million. Soybean meal imports reached 110,818 MT in volume with a total value of $49 million. Imports of other biotechnology products from countries other than the United States are limited or non-existent.

FOOD AID RECIPIENT COUNTRIES: Nicaragua continues to be a large food aid recipient due to its limited capacity to supply food for human and animal consumption. At present, imports of GE crops for human consumption are not allowed since the Nicaraguan Commission of Risk Analysis of Living Modified Organisms (CONARGEM) has only approved the use of such crops for animal feed purposes. Non-GE crops and some GE processed food products - such as textured soy protein, soybean flour and refined vegetable oils - are accepted for use in food assistance programs.

PART B: POLICY

REGULATORY FRAMEWORK: The two Nicaraguan institutions responsible for regulating GE plants and animals are the new Institute of Agricultural Health and Protection (IPSA) and the Ministry of Natural Resources and Environment (MARENA). Additionally, there are two commissions, the National Commission on Bio-safety (CONABIO) and the Commission of Risk Analysis of Living Modified Crops (CONARGEM), that serve as advisory bodies for the Government of Nicaragua (GON) on issues related to biosafety of GE crops and animals.

Nicaragua became a party to the Cartagena protocol in 2003. That same year, the GON began requiring notifications for imports of GE crops and risk analyses for biotech events. However, no commission to perform such risk analyses was created until July 23, 2004, when CONARGEM was formed to be the GON's advisory body on biosafety of GE crops and Animals.

On April 13, 2010, the GON published Law 705 on the prevention of risks arising from organisms derived from new technologies through molecular biotechnology. This law supersedes chapter XVI of the basic law of Animal and Plant health (Law 291) and establishes a complete comprehensive science-based framework for the use of GE organisms in confined use, research, release into the environment, commercialization (exports and imports), reproduction, multiplication, evaluation of field production, transportation, transit, bio-medication, conservation, and other uses. To date, Law 705 has not been operational because it lacks the procedural norms for implementation. This creates a major limitation to the Nicaraguan biotechnology legal framework, as regulations cannot be implemented.

IPSA:The Institute of Agricultural Health and Protection (IPSA) is the competent authority for the implementation of the Nicaraguan biotechnology law (Law 705) in the fields of agriculture, forestry and aquaculture. IPSA is the legal entity that superseded the former General Direction of Animal and Plant Health Protection (DGPSA) which was responsible for conducting risk analyses of new GE crops.

MAG: The role of the Ministry of Agriculture and Livestock (MAG) is to formulate, implement and monitor agricultural policies (including biotechnology policies) that can have a positive economic, social and environmental impact and improve the livelihoods of small, medium and large farmers.

MARENA:The Ministry of Environment and Natural Resources (MARENA), through the General Direction of Biodiversity and Natural Resources, is the competent authority for the implementation of Law 705 on issues related to bioremediation, conservation, preservation and other uses related to biological diversity.

CONABIO: The National Commission on Bio-safety (CONABIO) has the main function of harmonizing and recommending policies related to the use and implementation of biosafety measures of GE crops. CONABIO also provides advice to the President of Nicaragua on issues related to biosafety. CONABIO is formed by MAG, MARENA, Ministry of Trade, Ministry of Health, Secretary of the Nicaraguan Council of Science and Technology, an independent plant scientist, and four independent academics with experience on biosafety.

CONARGEM: The Commission of Risk Analysis of Living Modified Organisms (CONARGEM) is the advisory body on biosafety to the Government of Nicaragua (GON), assigned to MAG and MARENA on a rotational basis. Every six months CONARGEM's presidency pro-tempore shifts between MAG and MARENA. CONARGEM's roles include reviewing requests related to the approval of new biotech events, proposing guidelines for the risk analyses of GE crops, developing procedural norms for operations, and assisting the GON to formulate policies and strategies related to biosafety. Note: CONABIO is more of an advisory body to the President while CONARGEM is the commission responsible for analyzing requests related to the approval of new biotech events.

THE APPROVAL PROCESS FOR NEW GE EVENTS:According to Law 705, the regulatory procedures for the approval of GE food, feed, processing and environmental releases are the same. Complete approval usually takes 270 days beginning the day after the competent authority receives completed applications. Comment: At this time, importers and/or exporters cannot request the approval of new GE events since the Law 705 lacks the internal procedural norms (including the procedures to conduct risk analyses for GE crops) required for its implementation.

APPROVALS: At the moment, there are no GE corn events legally approved in Nicaragua. In 2005, the GON announced Ministerial Resolution 034-2005 which approved the issuance of phytosanitary permits for 15 GE corn events (676, 678, and 680, MS3, MS6, BT 176, BT11, CT 1507, MON 863, MON 810, T14, T25, DLL25, and GA21). However, this ministerial resolution is no longer current. The private sector is pressuring the GON to finalize the implementing regulations of Law 705 and to update the aforementioned resolution as soon as possible.

FIELD TESTING:Up to now, CONARGEM has not approved any GE crop for cultivation and, therefore, field testing is not allowed.

STACKED EVENT APPROVALS: Law 705 does not distinguish between the approval process for plants that combine two or more approved traits and plants that have just one approved trait. Stack event approvals follows the same procedures of any GE crop described in article II and III of Law 705.

ADDITIONAL REQUIREMENTS: There are no additional requirements once the solicitation has been approved.

CO-EXISTENCE:As part of the risk assessment process for new biotech events stipulated in Law 705, the competent authority, with the advice of the CONARGEM, may establish restricted areas for the release and use of living modified organisms. Therefore, policy measures related to the co-existence between GE and non GE crops will be considered on a case-by-case basis according to the results of the risk analyses.

LABELING: Nicaragua does not have a specific law for the labeling on GE crops. However, according to Law 705, GE exporters will need to comply with the provisions established in the Cartagena Protocol on Biodiversity and international and regional agreements on this matter. For the specific case of labeling seeds, exporters will need to comply with Nicaraguan Law 280 on Production and Trading of Seeds which was approved on December 10, 1997, and published in the official Gazette on February 9, 1998. This regulation states that seed bags must have a label with information specifying its characteristics, genetic identification, germination, recommendations for management and conservation, quality and volume, etc.

TRADE BARRIERS:U.S. GE corn and soybean meal have been entering the Nicaraguan market without major problems for a long time. However, Nicaragua has a major limitation within the legal framework to regulate GE crops as explained above. The principal law that regulates GE crops and animals (Law 705) lacks the internal procedural norms for its implementation. This creates problems for importers who cannot request the approval of new GE crops because CONARGEM cannot evaluate the requests and make final determinations. Another drawback is that Ministerial Resolution (034-2005) that approves the imports of 15 GE corn events is no longer current and some previously approved events have been discontinued.

INTERLLECTUAL PROPERTY RIGHTS (IPRs):Nicaragua has a specific law (318) on Plant Variety Protection that establishes the standards to protect the rights of natural and legal persons that have created, discovered or developed new plant varieties either by natural means or genetic manipulation.

CARTAGENA PROTOCOL RATIFICATION:Nicaragua is signatory of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. It ratified the protocol on August 28, 2002, and entered into force in September 2003.

INTERNATIONAL TREATIES/FORA: Nicaragua is a member of several international organizations including Codex Alimentarius, OIE, COP-MOP and IPPC.

RELATED ISSUES: Not applicable.

MONITORING AND TESTING: MAGFOR requires the testing for GE traces on all imported grain shipments. The tests are conducted by the Central American University Biotechnology Lab. A main purpose of the lab tests is to identify if the imported commodities have GE positive traces. In the case of corn, MAGFOR has a specific protocol that involves the custody of containers to make sure that corn seeds are not used for cultivation.

LOW LEVEL PRESENCE POLICY:Nicaragua does not have a low level presence policy of GE crops.

PART C: MARKETING

MARKET ACCEPTANCE AND PUBLIC/PRIVATE SECTOR OPINIONS: Public awareness of GE emerging technologies among Nicaraguans is still limited. There are only three laboratories in the country - the Central American University, the National Autonomous University and the Polytechnic University - which perform GE testing and research.

The Nicaraguan market is new to the concept of GE technologies. However, the private sector is interested in increasing the number of approved biotech events for corn and, in the future, to have GE crops approved for cultivation. The opposition to biotechnology comes mainly from some anti-biotechnology NGOs which are very active in Nicaragua and promote initiatives that aim to rescue, preserve and enhance native seeds, while refusing entry of GE planting seeds into the country.

Some Nicaraguan universities have started to include biotechnology in their curriculum as they recognize the potential it has to contribute to food security, agricultural development and the environment. In 2013, the Nicaraguan Council of Science and Technology (CONICYT) officially inaugurated the first Master's degree program in biotechnology with the objective of promoting excellence in scientific research and technological development, train biotech professionals and improve awareness among Nicaraguan citizens.

MARKET STUDIES: Not applicable.

CHAPTER 2: ANIMAL BIOTECHNOLOGY

PART E: PRODUCTION AND TRADE

BIOTECHNOLOGY PRODUCT DEVELOPMENT: There are no GE animals under development in Nicaragua at this time.

COMMERCIAL PRODUCTION: Nicaragua does not commercially produce any livestock clones or GE animals or products derived from animal biotechnologies.

BIOTECHNOLOGY EXPORTS: Nicaragua does not export any GE animals, livestock clones, or products from these animals at this time.

BIOTECHNOLOGY IMPORTS: Nicaragua has not imported GE animals or livestock clones or products from these animals.

PART F: POLICY

REGULATION: Law 705 (The Prevention of Risks Arising from Organisms Derived from New Technologies through Molecular Biotechnology) provides MAG and MARENA with the legal authority to regulate animal biotechnology in Nicaragua.

LABELING AND TRACEABILITY: Labeling regulations have not been developed for products of animal biotechnology in Nicaragua.

TRADE BARRIERS: The principal law that regulates GE crops and animals (law 705) lacks the internal procedural norms for its implementation. Please refer to the section of trade barriers on the plant biotechnology chapter.

INTELECTUAL PROPERTY RIGHTS (IPR): There are no IPR laws for GE animals.

INTERNATIONAL TREATIES/FORA: Nicaragua participates in the World Organization for Animal Health (OIE), although Post is not aware of any specific interventions by Nicaraguan officials on the subject of animal biotechnology.

PART G: MARKETING

MARKET ACCEPTANCE: The information provided above regarding the acceptance of plant biotechnology generally applies to animal biotechnology as well. Post expects the issue to be controversial if and when it becomes a public discussion topic.

MARKET STUDIES: Not applicable.

PART H: CAPACITY BUILDING AND OUTREACH

AC TIVITIES: No activities have been developed by Post over the last few years focusing on animal biotechnology.