Required Report: Required - Public Distribution

Date: December 05, 2023
Report Number:

HO2023-0009

Report Name: Agricultural Biotechnology Annual
Country: Honduras
Post: Tegucigalpa
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Juan Fiallos

Approved By: Andrew Hochhalter
Report Highlights:
Honduras has made no modifications or changes to its existing regulatory framework. As of October
2023, Honduras had more than 55,000 hectares (ha) of genetically engineered (GE) corn production, a
6% increase from CY 2022. Two crop event approvals were reported during 2023 for extended shelf lifeand non-browning bananas. Both applications were approved for field testing.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYEXECUTIVE SUMMARY
Major U.S. agricultural exports to Honduras are yellow corn, soybean meal, wheat, pork, beer, rice,
dairy products, cotton, poultry, and prepared food products. Honduras’ production of geneticallyengineered (GE) plants is mainly corn used for feed, food, and cultivation.
In CY 2023, NCBB approved two applications for GM bananas 2 for field testing: i) a non-browningbanana, ii) extended shelf-life banana. Additionally, The Honduran Government is making progress oncreating a procedure manual for regulation of GE animals.
Honduras has pioneered regulatory development for biotechnology products in Central America. Since
1998, Honduras’s biotechnology system has been regulated under the “Biosecurity Regulation with
Emphasis in Transgenic Plants”. On March 15, 2019, El Salvador, Guatemala, and Honduras approved aTechnical Regulation (TR) for the commercial exchange and safe use of agricultural biotechnology
under their tripartite accelerated customs union agreement. On October 1, 2019, the rule entered effectfor Guatemala and Honduras. The TR applies to plants and the reproduction of animals (such as themosquito that causes the dengue disease). Procedural Manuals need to be developed for full
implementation.
Planted area of GE corn as of October 2023 is estimated at 55,000 hectares (ha), 6% higher than the
38,000 hectares (ha) in the previous year. GE plant cultivation is restricted in three of the 18
departments, Intibucá, Lempira and Gracias a Dios, as well as in the municipality of Pespire, Choluteca.
GE planting is also restricted in areas near native corn stocks and in regions higher than 1,000 meters
above sea level, as was requested by the Government of Honduras in order to protect native
communities.
Honduras’ production of GE corn seed is sold within the domestic market for agroindustry and is also
exported to Colombia. Honduras imports yellow corn and soybean meal to supply its poultry, livestock,
shrimp, and tilapia industries.
The National Committee on Biotechnology and Biosecurity (NCBB) was created in 1998. On January
10, 2018, SENASA published in the official Gazette the Guide of Processes and Procedures of theRegulatory System for “Genetically Modified Organisms.” The purpose of the guide is to update theprocedures of the NCBB, without changing the objectives and its duties and to provide users with theprocedures to follow in the field test, pre-commercial, and commercialization stages of new events. By
publishing this guide in the Official Gazette, the guide became an official regulation. Previously, thesewere just internal regulations.
On September 2019, SENASA established a simplified procedure to approve the requests for genome
edited products. The new process reduces the approval time of requests. The regulations state that thecommittee will conduct a case-by-case study to discuss whether the product can be approved in a
simplified way.

TABLE OF CONTENTS

CHAPTER 1: PLANT BIOTECHNOLOGY ........................................................................................................ 3
PART A: Production and Trade............................................................................................................................. 3
PART B: Policy ....................................................................................................................................................... 4
PART C: Marketing ............................................................................................................................................. 12
CHAPTER 2: ANIMAL BIOTECHNOLOGY ................................................................................................. 12
PART D: Production and Trade ......................................................................................................................... 12
PART E: Policy ...................................................................................................................................................... 13
PART F: Marketing ............................................................................................................................................. 13
CHAPTER 3: MICROBIAL BIOTECHNOLOGY .......................................................................................... 14
PART G: Production and Trade .......................................................................................................................... 14
PART H: Policy .................................................................................................................................................... 14
PART I: Marketing ............................................................................................................................................... 14

CHAPTER 1: PLANT BIOTECHNOLOGYPART A: Production and Tradea) RESEARCH AND PRODUCT DEVELOPMENT: In Honduras there is no development ofantibiotics, functional foods/feeds, or pharmaceuticals using GE techniques or GE plants.
b) COMMERCIAL PRODUCTION: Honduras allows the commercial cultivation of GE crops forcorn seed and grain production. Area planted with GE corn for commercial seed and grain from October
2022 to October 2023 was 55,000 hectares (ha), a 6% increase from the previous year. The increase inplanted area was a consequence of a general market recovery after the economic reopening in Honduras
after COVID 19 and Climatic phenomena in the Sula Valley.
c) EXPORTS: Honduras exports GE corn seeds to Colombia. Honduras exported GE corn seeds to theUnited States from 2009 to 2014. In shipments containing these seeds, documentation declares thecontent of GE material. The product exported to the United States has received approval from the U.S.
regulatory system.
d) IMPORTS: Honduras imports GE crops, processed products, and seeds directly into the country. GE
seeds are imported from the United States and Brazil. Most imports of yellow corn and soybean mealfrom the United States are GE. These imports are to support the poultry, livestock, shrimp, and tilapia

industries. In 2022, Honduras imported U.S. corn (mostly GE yellow corn) valued at $293.53 million, a
44% increase compared to 2021. Imports of GE soybean meal from the United States were$187.28 million, a 23% increase compared to 2021.
e) FOOD AID: Honduras has been a food aid recipient since 1999. The Government of Honduras(GOH) has accepted U.S. food donations of soybean meal and yellow corn for the agroindustry. There
are no barriers related to biotechnology that impede the importation of food aid.
f) TRADE BARRIERS: Not applicable.

PART B: Policya) REGULATORY FRAMEWORK:
Table 1: Legal and Regulatory Terms used in Honduras
Legal term (Spanish)
Reglamento de
Bioseguridad conénfasis en plantas
transgénicas

Comisión Nacional debiotecnología yBioseguridad Agrícola(CNBBA)

Legal Term (inEnglish)Biosecurity Regulation
with Emphasis on
Transgenic Plants

Laws and Regulations
where term is used
Agreement No.1570-98
and modified by
Decree No. 344-2005
published in 2006

Legal Definition (inEnglish)The biosecurity
regulation gives
SENASA responsibility
for the regulatory
framework for
agricultural
biotechnology,
including GE productimport requests, fieldtesting, andcommercialization
requests for GE crops.
The regulation applies
to food, feed, seed, andenvironmental safetyissues.

National Committee of
Biotechnology andAgriculture Biosecurity(NCBB)SENASA Agreement
No. 177-2017

It is an advisory bodyand chaired by the
Department ofCertification of Seeds
and Phyto genetic
Resources of the
National Agricultural
Health Service(SENASA).

The function of the
Biosafety Committee isto carry out all thetechnical evaluations
that are required in thebiotechnology projects
that are carried out inthe country. These
include risk assessment
at each step of theprocess and for eachspecific case, thisinvolves carrying out
laboratory tests,
analysis, investigationand expert consultation.
This committee meetsat least three times ayear and is in charge ofproviding technicaladvice to whoever
consults on the subject.

Acuerdo CD SENASA
008-2019 ;Procedimiento deautorización parasolicitudes relacionadas

SENASA Agreement008-2019;
Authorization
procedure forapplications related to

SENASA Agreement008-2019

When an application ismade to allow anexperiment in the
country, a complete
study is made that
includes: type oforganism, itsconstruction andbehavior, the objectiveof the modification,
information provided
by the provider andalso by internationalorganizations, as wellas the experience withsaid organism in othercountries.
This regulation was
created because theadvancement of scienceand technology allows
the development of

con el uso de nuevas
técnicas demejoramiento genético
(biotecnología deprecisión)

the use of new genetic
improvement
techniques (precisionbiotechnology)

new varieties of plants
and organisms throughnew techniques known
as precision breeding
techniques, genome
editing, plant breeding
innovation or modern
genetic improvement
techniques without thisresults in a living
modified organism.
The latter is of vital
importance in theapplication of the
National regulations,since these are genetic
improvement
procedures that use
precise knowledge ofthe relationshipbetween the genotype
and phenotype and thetools of molecularbiology, to develop an
organism that in mostcases are equivalent toor indistinguishable
from those that can be
developed using
traditional breeding
techniques.

The Secretariat of Agriculture and Livestock (SAG), through SENASA, oversees the regulation of GE
plants. SENASA’s Seeds and Plant Genetic Resources Certification Department initiated the Biosecurity
Regulation with Emphasis on Transgenic Plants, which was approved by the GOH in 1998 throughAgreement No.1570-98. The legal basis for this regulation is the Phytozoosanitary Law. The law was
reviewed and modified by Decree No. 344-2005 published in 2006. These regulations can be found in
Spanish here: https://www.senasa.gob.hn/index.php/acuerdos/subdireccion-general-de-sanidad-vegetal
The biosecurity regulation gives SENASA responsibility for the regulatory framework for agricultural
biotechnology, including GE product import requests, field testing, and commercialization requests for
GE crops. The regulation applies to food, feed, seed, and environmental safety issues.
On March 15, 2019, the El Salvador, Guatemala, and Honduras Customs Union approved a TechnicalRegulation (TR) for the commercial exchange and safe use of agricultural biotechnology. The TR
applies to plants and the reproduction of animals (such as the mosquito that causes the dengue disease).

Procedure Manuals need to be developed for full implementation. On October 1st, 2019, therule entered effect for both countries, although most changes affected only Guatemala, since Honduras
has already adopted the underlying regulation.
On September 2019, SENASA approved a simplified procedure to approve products produced
using gene editing. The new procedure complies with the GOH SPS commitments to the World Trade
Organization. Furthermore, it helps to shorten the approval time of each request.
SENASA would like to further develop Honduras’s biotechnology regulations. However, during 2023,
there have been no advances on biotechnology regulatory framework development, the manual ofprocedures for the regulation of animals has been postponed due to the lack of Government consensus
with the Ministry of Health.
The Biosecurity Regulation with Emphasis on Transgenic Plants provides the procedures to evaluate arequest and assigns the scientific analysis to the National Committee of Biotechnology and Biosecurity(NCBB). The NCBB was created in 1998 to provide advice to SENASA in the decision-making process.
In January 2018, a new decree was published by SENASA in the Official Gazette to update theprocedures of the NCBB, without changing the objectives and its responsibilities. The Committee iscomposed of scientists from the following ten public and private institutions:• SENASA: Focal point for the Cartagena Protocol.
• Directorate of Science and Agricultural/Livestock Technology (DICTA)/SAG• Focal Point of the Codex Alimentarius in SAG• Ministry of Public Health• Ministry of Renewable Resources and Environment (Mi Ambiente)• Competitiveness and Innovation Directorate, Secretariat of Planning (SEPLAN)• National University of Honduras (UNAH)• Honduran Foundation for Agricultural Research (FHIA)• Pan American School of Agriculture - “Zamorano”• Standard Fruit Company
After the NCBB provides a scientific recommendation, the political decision for an approval of an event
and its commercialization is with the Director General of SENASA. The legal grounds of
the Phytozoosanitary Law published in 2006 and the Regulation with Emphasis on Transgenic Plants are
to provide the Director General of SENASA reliable tools to make decisions about field trials, semicommercialization, and commercialization of GE crops.
Honduras does not make distinctions in regulatory treatment for approval between food, feed,
processing, and environmental release (cultivation).
The commercialization of GE products in Honduras does not affect U.S. exports. This is because of theapproved legal framework, and the acceptance of industry and consumers of GE products from theUnited States. The Law for the Protection of New Varieties of Plants (UPOV) was approved by Decree
21-2012 of the Honduran Congress in 2012. Although UPOV was approved, the accompanying
regulation is still pending. The law can be found in Spanish at SENASA Technical Directorate of Plant
Health.
The process for the commercialization of an event has been officially published through the Guide ofProcesses and Procedures of the Regulatory System for “Genetically Modified Organisms” for Decision
Making. The publication was made in the Official Gazette No. 34,538 of January 10, 2018. The purposeof the guide is to communicate and provide users with the procedures to follow in the stages of field test,
pre- commercial, and commercialization. The approval process is the following:• The NCBB recommends that companies carry out field tests within normal production cycles: the firstcycle of planting begins in May or June, and the second cycle begins in August or September.
• After the test stage is completed, the NCBB advises SENASA to extend the pre-commercial area fromone hectare up to 500 hectares, depending on the company's request.
• The regulation for biosecurity indicates that the NCBB should provide an answer to a request within 90
days. The estimated time until commercialization varies according to the questions that the NCBB may
raise. In some cases, the NCBB requests more information from field tests as part of the pre- commercial
stage.
• After the NCBB reaches a consensus, it provides a scientific recommendation and forwards
the decision for approval of an event and its commercialization to the Director General of SENASA.
• The Director of SENASA notifies the resolution and findings of the NCBB to the requesting
company.
The National Committee on Biotechnology and Biosecurity (NCBB) wrote the guidelines below forfirms looking at Honduras as an export market for GE crops. The document is complementary to the
Biosecurity Regulation with Emphasis in Transgenic Plants issued in 1998 and is meant to ease theprocess and attract interest in GE crop development for export purposes.
The risk evaluation guidelines indicate that GE crop developers requesting a risk evaluation for a test
trial, or the commercial liberation of a GE product must provide the following information to the
Biotechnology and Biosafety Committee:• Personnel involved: Names, addresses, and telephone numbers of the people that have developed or
supplied the event.
• Purpose of the evaluation: Provide a detailed description of the purpose of the introduction of theevent, including the experimental design and/or the proposed production.
• Description of the genetic material: Provide a description of the desired or real characteristic of themodified genetic material. Also include how the characteristic differs from the parent non-modified
organism (i.e., morphologic or structural characteristics, activities and physiological processes, numberof copies of the material inside of the recipient organism (integrated or extra-chromosomic) products andsecretions and characteristics of growth.

• Transformation methods: Country and place where the parent plant, the receptor organism and thevector were collected, developed, and produced. Transformation methods and selection processes
employed.
• System used to produce the event: Provide a detailed description of the molecular biology of thesystem that will be used to produce the event (for example: donor-recipient-vector).
• Place of evaluation: Country and geographic location of the evaluation, specifying the exact
description of the areas to be evaluated.
• Biosecurity measures: Provide a detailed description of the processes and security measures that havebeen used or will be used to prevent the contamination, liberation and dissemination of the donororganism, the recipient organism, the vector, the constituent of each event and the event in the countryof origin, in the countries that will be in transit and in Honduras.
• Programmed destination: Provide a detailed description of the programmed destination (including thefinal destination and all the intermediary destinations), uses, and/or distribution of the event (Example:
greenhouses, laboratories, or place of the growth chamber, site of the field test, site of the pilot project,production, spreading, manufacturing site, proposed site of sale and distribution).
• Containment measures: Provide a detailed description of the procedures, processes and security
measures proposed that will be used to prevent the escape and spreading of the event in each of the
programmed destinations.
• Method of final disposal: Provide a detailed description of the proposed method for the final disposalof the event.

b) APPROVALS/AUTHORIZATIONS:In CY 2023, NCBB approved two applications for GM bananas 2 for field testing: i) non-browningbanana, ii) extended shelf-life banana. Additionally, The Honduran Government is making progress oncreating a procedure manual for regulation of GE animals.
Table 2 shows currently approved events per crop. Authorizations for planting do not have an expiration
date.

Table 2. Approved Crop/Events
Approval Company
Year

Crop

Event

2002

MonsantoCorn

MON 810 + NK 603 Commercial Feed, food, andseed production

2010

PioneerCorn

TC 1507

Type of
Approval

Usage

Commercial Feed, food,cultivation
2011

Bayer Crop Science Rice

LLRice 62

Commercial Food only

2012

MonsantoCorn

MON 89034

Commercial Feed, food andseed production

2013

MonsantoCorn

MON 88017

Commercial Feed, food andseed production

2013

MonsantoCorn

MON 89034 + MON Commercial Feed, food and
88017
seed production

2015

Dow AgroscienceCorn

MON 89034 + NK
603 + TC 1507

Commercial Feed, food,cultivation

2020

Syngenta Crop
Protection SACorn

SYN BT11 x MIR
162 x
GA21, Agrisure ®
VIP3

Commercial Feed, food andseed production

2022

Tropic Biosciences Banana

Non Browning
Cavendish Banana

Experimental Food production

2022

Tropic Biosciences Banana

Non Browning
Cavendish Banana

Commercial Food production

2022

Tropic Biosciences Banana

Extended Shelf Life Experimental Food production
Banana (ESL)2022

Standard Fruit
Company

BananaBanana resistant tofusarium race 42022

Pairwise Plants
Services Inc.

Mustard Brassica Juncea with Commercial Food production
improved flavor
Greenprofile */2023

Tropic Biosciences Banana

Extended Shelf life

Experimental Field Testing2023

Tropic Biosciences Banana

Non-Browning

Experimental Field TestingExperimental Food production

Source: SAG’s National Service of Food Safety, Plant and Animal Health (SENASA), Seeds
Certification Department. */ The approval follows a simplified procedure if not much modification isdone, it is recommended by NCBB as a simplified procedure but also regulatedc) STACKED EVENT APPROVALS: Honduras has approved stacked events since 2010. If an event isalready registered individually, it does not need to be registered again when it is part of a stacked event.
The NCBB requests that a risk analysis of the stacked event be reported to the Biosafety Clearing Houseof the Cartagena Protocol, but there is no other specific stacked event policy.
d) FIELD TESTING: Honduras currently allows field testing and commercialization of GE crops. The
requirements to request field testing and commercial liberation of an event are based on
the Phytozoosanitary Law and the Biosecurity Regulation with Emphasis on Transgenic Plants. The
process is the following: (1) a company submits a request to SENASA; (2) SENASA’s Director
summons the NCBB to review the request; and (3) each institution in the NCBB carries out its analysis.
Depending on issues raised during the analysis, they continue to meet until a consensus is reached. The
area for the field test is usually conducted on one hectare of land.
e) INNOVATIVE BIOTECHNOLOGIES: As noted above, in September 2019 SENASA approved asimplified procedure for approving products produced using gene editing, which will shorten theapproval time for such requests.
f) COEXISTENCE: GE corn is not planted in the three departments of Intibucá, Lempira or Gracias a
Dios, nor in the municipality of Pespire, Choluteca. GE planting is also restricted in areas near native
corn stocks, and in regions higher than 1,000 meters above sea level at the request of native
communities.
g) LABELING AND TRACEABILITY: SENASA requires labeling for GE corn seed for planting. It
does not require labeling for bulk shipments, raw material, packaged foods, feed, or other products
derived from and/or containing ingredients from GE plants.
h) MONITORING AND TESTING: Not applicable.
i) LOW LEVEL PRESENCE (LLP) POLICY: Not applicable.
j) ADDITIONAL REGULATORY REQUIREMENTS: After an
event is approved for commercialization, it must be registered at the Seeds and Plant Genetic Resources
Certification Department of SENASA prior to use. Registrations are not overly cumbersome and do not
expire.
k) INTELLECTUAL PROPERTY RIGHTS (IPR): The Law for the Protection of New Varieties ofPlants protects intellectual property rights of the developer of new varieties and the variety itself. Thislaw was approved by Decree 21-2012 by the Honduran Congress in 2012.
l) CARTAGENA PROTOCOL RATIFICATION: The Honduras Congress ratified the Cartagena
Protocol on Biosafety to the United Nations’ Convention on Biological Diversity in September 2008.
m) INTERNATIONAL TREATIES and FORUMS: Honduras actively participates in discussions related
to GE plants within international fora, sharing its positive experience to facilitate processes for the useof agricultural biotechnology.

Honduras approved the Law for the Protection of New Varieties of Plants (UPOV) in 2012. UPOV is anintergovernmental organization established by the International Convention for the Protection of New
Varieties of Plants. The Convention promotes an effective system of plant variety protection, with theaim of encouraging the development of new varieties of plants for the benefit of society. The
Procedural Manual required to implement UPOV has been postponed until further notice by SENASA,due to the new Government administration and some lobbying and dialogue efforts are suggested for it
to happen. Honduras phased out in 2022 the Law for the Protection of New Varieties of Plants (UPOV)
due to pressures from environmental organizations in Honduras.
n) RELATED ISSUES: Expanded use of biotechnology has the potential to benefit Honduran society.
There are nearly 200,000 ha. of non-GE corn planted in Honduras, using mostly traditional (non-hybrid)
seed. According to PROGRANO (Association of Grains Producers of Honduras in 2023 average cornyield for traditional (creole) seed was 1.5 metric tons per ha., for improved varieties average yield was
4.5 metric tons per ha., for hybrid seed average yield was 5.5 metric tons per ha., and for GE seeds
average yield was 7.6 metric tons per ha.

PART C: Marketinga) PUBLIC/PRIVATE OPINIONS: There are groups that conduct negative campaigns against GE
crops. These groups primarily are against all transnational companies that produce and sell seeds,
agrochemicals, and mining. The General Public and the Government of Honduras which has anenvironmental ideology, perceives biotechnology as a technological agricultural tool, the grain
producers and the public in general are the ones most supportive about biotechnology in Honduras.
b) MARKET ACCEPTANCE/STUDIES: Market acceptance related to the sale and use of GE plants
and products is favorable. Fruit and vegetable producers that grow for export rotate their crops with GE
corn. This helps to ensure that the fruit and vegetables exported are free of pesticide residues and pests.
Producers who use GE crops see a large increase in yields. The production of GE corn in Honduras
creates a sustainable process for medium and large farms, which have reduced
pesticide use, increased no-tillage cultivation, and increased rotation
with legumes to consistently produce high yields.
The Interamerican Bank for development (IADB) has finalized and published a regional market study
for agricultural biotechnologies, which was presented in the International Biotechnology Workshop held
in Argentina for its socializing stage.

CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: Production and Tradea) RESEARCH AND PRODUCT DEVELOPMENT: Not applicable.
b) COMMERCIAL PRODUCTION: In discussion and preparation of implementation strategies.
c) EXPORTS: Not applicable.
d) IMPORTS: Not applicable.
e) TRADE BARRIERS: Not applicable.

PART E: Policya) REGULATORY FRAMEWORK: On March 15, 2019, El Salvador, Guatemala, and Honduras
Customs Union approved a Technical Regulation (TR) for the commercial exchange and safe use of
agricultural biotechnology. The TR applies to plants and the reproduction of animals (such as
the mosquito that causes the dengue disease). Procedure Manuals for the reproduction of animals such as
the mosquito need to be developed. On October 1st, 2019, the rule entered effect for Guatemala andHonduras.
b) APPROVALS/AUTHORIZATIONS: Not applicable.
c) INNOVATIVE BIOTECHNOLOGIES: Not applicable.
d) LABELING AND TRACEABILITY: Not applicable.
e) ADDITIONAL REGULATORY REQUIREMENTS: Not applicable.
f) INTELLECTUAL PROPERTY RIGHTS (IPR): Not applicable.
g) INTERNATIONAL TREATIES and FORUMS: Not applicable.
h) RELATED ISSUES. Not applicable.

PART F: Marketinga) PUBLIC/PRIVATE OPINIONS: Not applicable.
b) MARKET ACCEPTANCE/STUDIES: Not applicable.

CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: Production and Tradea) COMMERCIAL PRODUCTION: FAS Tegucigalpa is not aware of commercial production of foodingredients derived from microbial biotechnology in Honduras.
b) EXPORTS: Not applicable.
c) IMPORTS: Honduras imports food ingredients such as enzymes and additives for different foodprocessing activities. However, the volume or value of these imports, and whether the products arederived from microbial biotechnology could not be determined.
d) TRADE BARRIERS: Not applicable.

PART H: Policya) REGULATORY FRAMEWORK: Not applicable.
b) APPROVALS/AUTHORIZATIONS: Not applicable.
c) LABELING and TRACEABILITY: Not applicable.
d) MONITORING AND TESTING: Not applicable.
e) ADDITIONAL REGULATORY REQUIREMENTS: Not applicable.
f) INTELLECTUAL PROPERTY RIGHTS (IPR): Not applicable.
g) RELATED ISSUES. Not applicable.

PART I: Marketinga) PUBLIC/PRIVATE OPINIONS: Not applicable.
b) MARKET ACCEPTANCE/STUDIES: Not applicable.

Attachments:

No Attachments