US embassy cable - 03TEGUCIGALPA2551

UNCLAS SECTION 01 OF 04 TEGUCIGALPA 002551 
 
SIPDIS 
 
STATE FOR EB/TPP/ABT/BTT (DMALAC), OES/ETC(HLEE), AND 
WHA/CEN 
USDA FOR USDA/FAS/OA/BSIMMONS AND USDA/APHIS/BRS/JTURNER 
STATE PLEASE PASS TO USAID FOR JLEWIS 
STATE PLEASE PASS TO FDA FOR RLAKE 
STATE PLEASE PASS TO EPA FOR JANDERSEN 
GUATEMALA FOR AGATT 
 
E.O. 12958: N/A 
TAGS: EAGR, ECON, ETRD, SENV, TBIO, PGOV, HO, TSLP 
SUBJECT: Biotechnology Regulations: Honduras 
 
REF: State 263456 
 
1.  Post contacted Carlos Almendares, the GOH official most 
directly responsible for biotechnology issues, and received 
the information below.  Mr. Almendares is the Chief of the 
Seed Certification Department in the Honduran National 
Service for Animal and Plant Health (abbreviated SENASA, 
equivalent to our APHIS), within the Ministry of Agriculture 
and Livestock.  The following answers are keyed to the 
questions in paragraph 4 of reftel. 
 
Q1.  What are the dates relevant laws and regulations became 
effective? 
 
A1.  The Phytozoosanitary Decree 157 was passed in 1994. 
This law establishes that the National Service for Animal 
and Plant Health (SENASA), in co-ordination with the 
Ministry of Health, has the responsibility for issuing 
regulations for the import and use of biotech products. 
 
The regulations based upon this law were approved and came 
into effect in 1998.  These regulations were based upon 
those of Mexico, Argentina and Colombia, though the Honduran 
regulations are less strict than those of the other 
countries. 
 
In addition, a National Committee of Biotechnology and 
Biosafety was established in 1997 and meets four times a 
year.  This committee is made up of representatives from the 
following organizations: 
 - the Seed Certification Department of SENASA, 
 - the Sanitary Regulations Department of the Ministry of 
Health, 
- the Biodiversity Unit of the Ministry of Environment and 
Natural Resources, 
 - the Pan American School of Agriculture at Zamorano, 
 - the Honduran Foundation of Agricultural Research (FHIA), 
 - the National University (UNAH), 
 - the National Council for Science and Technology (a semi- 
autonomous government institution), 
 - the National Association of Seed Producers and 
Distributors (an industry organization), and 
 - the Standard Fruit Company (someone with a scientific 
background). 
 
Q2. Is there a regulatory process in place for approving 
products of agricultural biotechnology for import or sale? 
If so, please provide a brief description of this process. 
 
A2.  The approval process for the import or sale of biotech 
products is as follows. 
 
First, any party which wishes to import or distribute any 
seeds in Honduras, whether biotech or not, must register 
with SENASA and pay a registration fee of 1,500 Lempiras 
(USD 86).  The registration process is simple - a one page 
application.  In addition, if the party wishes to import a 
biotech product, they must pay an additional registration 
fee of 5,000 Lempiras (USD 286). 
 
Then, the party that wishes to import biotech products must 
submit an application to SENASA, which passes it on to the 
National Committee of Biotechnology and Biosafety. 
 
The National Committee requires a risk evaluation of the 
product in question.  In some cases the Committee has 
accepted the results of an analysis done by another country. 
(For example, import of corn BT was approved based on an 
analysis done by the FDA.)  However, the Committee usually 
recommends that the risk analysis be performed in Honduras. 
Currently there are three organizations which conduct these 
risk evaluations: the Honduran Foundation of Agricultural 
Research (FHIA), the National University (UNAH), or the Pan 
American School of Agriculture at Zamorano. 
 
If the risk evaluation is performed in Honduras, the 
importing party is responsible for the cost.  The risk 
evaluation can take as little as three months, but in one 
case (a variety of banana) has been ongoing since 1997. 
 
As part of the risk evaluation, the effectiveness of the 
biotech product is also tested.  For example, if a variety 
claims to be drought-resistant, tests are also performed to 
evaluate whether the variety truly is resistant to drought 
in the Honduran context - essentially, whether the product 
does what it claims to do. 
The National Committee reviews the application and the risk 
evaluation and makes a recommendation on whether or not to 
allow the import of the product.  However, the final 
decision is made by the head of SENASA. 
 
Q3.  Which governmental departments or ministries monitor 
and/or enforce the laws or regulations? If possible, please 
provide contact information for a government official within 
each department or ministry which plays a role in the 
regulation of agricultural biotechnology. 
 
A3.  In the Ministry of Agriculture and Livestock: 
 
Carlos Almendares 
Chief Department of Seed Certification 
Avenida La FAO, Edificio SENASA 
2do. Piso - Sanidad Vegetal 
Tel. (504) 239-7270 
E-mail:calmendares81(at)yahoo.com 
certisem(at)optinet.hn 
 
Eduardo Salgado 
Sub-Director of Plant Health 
Avenida La FAO, Edificio SENASA 
2do. Piso - Sanidad Vegetal 
Tel. (504) 235-8425 
E-mail: escambar(at)yahoo.es 
 
Lizardo Reyes 
General Director SENASA 
Avenida La FAO, Edificio SENASA 3er Piso 
Tel. (504) 239-7067 
E-mail: direccionsenasa(at)multivisionhn.net 
senasa-sag(at)multivisionhn.net 
 
Q4.  What does this monitoring and/or enforcement by the 
government departments or ministries entail?  What are the 
penalties for failing to comply? 
 
A4.  According to the law, penalties for failing to comply 
with the regulations range from 100 to 100,000 Lempira (USD 
6 to USD 5,737 at the current exchange rate).  The maximum 
penalty is reserved for cases of serious harm to human, 
animal or plant health or irreversible damage to the 
environment or ecosystem.  However, Mr. Almendares of SENASA 
knows of no case in which any fine has actually been imposed 
for failure to comply with laws concerning biotech products. 
 
Q5. Are shipments of agricultural products tested for 
biotech content, and if so, whether this testing is done on 
a random or regular basis? 
 
A5.  No shipments are tested at the port of entry to 
determine if they contain biotech content.  The only testing 
done is as part of the risk evaluation, as explained above 
in A2. 
 
Q6.  Has the country put in place or is it contemplating 
implementing a traceability system for the products of 
agricultural biotechnology, and if so, the details of this 
system? 
 
A6.  A traceability system is currently being considered by 
the Ministry of Agriculture and Livestock, and may be put 
into place as early as April 2004.  The system would be 
managed by SENASA. 
 
Q7.  Is special documentation required for agricultural 
products which may contain the products of agricultural 
biotechnology?  If so, what types of documentation are 
required? 
 
A7.  At the port, there is no special documentation required 
for the import of biotech products (as long as their import 
has been approved through the process described in A2 
above). 
 
Q8.  Are in-country field tests required prior to regulatory 
approval of a biotech crop? 
 
A8.  Yes, field tests are required as part of the risk 
evaluation included in the application process described in 
A2. 
 
Q9.  Exactly what constitutes a complete packet of 
information required by government regulators for 
consideration of approval of a biotech crop? 
 
A9.  The National Committee of Biotechnology and Biosafety 
requires the following information: 
 
1. Staff information: Names, addresses and telephone numbers 
of people that have developed and/or supplied the regulated 
product. 
 
2. Purpose: Detailed description of the purpose of the 
regulated product, (i.e., drought resistance, pest 
resistance, etc.) 
 
3. Description of genetic material: Description of the 
genetically modified material in the organism and how it 
differs from the non-modified organism. 
 
4. Transformation methods: Place and country where the 
organism was developed and produced; methods of 
transformation and selection processes used. 
 
5. Production system: A detailed description of the 
molecular biology of the system used to produce the biotech 
product (example: donor-recipient-vector). 
 
6. Evaluation location: If a risk evaluation for the product 
in question has already been performed, the country and 
specific location of the evaluation. 
 
7. Biosecurity measures: A detailed description of the 
processes and security measures used in the country of 
origin, and that will be used in Honduras, to avoid 
contamination and dissemination of the regulated product. 
 
8. Intended destination: A detailed description of the 
intended destination, uses and distribution of the regulated 
product (for example: location of green houses, labs, field 
tests, pilot projects, production, dissemination, 
processing, sale, distribution). 
 
9. Containment measures: A detailed description of the 
procedures, processes and security measures proposed that 
will be used to prevent the escape and dissemination of the 
regulated product at each of the intended destinations 
listed in 8, above. 
 
10.  Final disposition: A detailed description of the 
proposed method for final disposal of the regulated product. 
 
11.  Bibliography: A list of any articles or research 
pertaining to the regulated product. 
 
Q10.  Must foods containing the products of agricultural 
biotechnology be labeled, and if so, what threshold 
percentage of both intended and adventitious presence would 
trigger the labeling requirement? 
 
A10.  Currently, Honduras has no labeling requirements for 
biotech products. 
 
Q11.  If a label is required for food and feed containing 
the products of agricultural biotechnology, what are the 
contents of a label text? 
 
A11.  n/a 
 
Q12. What level of food products (i.e. unprocessed vs. 
consumer-ready) must carry a label? 
 
A12.  n/a 
 
Q13. Is there any law or regulation governing the use of 
labels such as "biotech-free", "non-biotech," "GMO-free" or 
"non-GMO?" 
 
A13.  No, there is not. 
 
Q14. In countries where no formal laws or regulations have 
been promulgated or enforced, what is the likelihood that 
the host government will enact them in the near future? 
 
A14.  n/a 
 
Palmer