Agreement CD-SENASA-004-2022

It is the responsibility of the National Service of Sanitation and Agro-food Safety (SENASA), through the Technical Directorate of Animal Health, to direct and execute the National Poultry Program (PAN). For this purpose, it shall coordinate support actions with other units of SENASA, State institutions, the private poultry productive sector through the different associations of poultry farmers, international organizations, civic organizations, and others as applicable in their respective field.

This Regulation is mandatory throughout the entire national territory and the following individuals or legal entities related to the poultry sector are obliged to comply with its provisions:

• a)

  Personnel of the Secretariat of Agriculture and Livestock and other State agencies;

• b)

  Professionals and technicians;

• c)

  Producers and Owners;

• d)

  Processors of poultry, products, and by-products;

• e)

  Merchants;

• f)

  Exporters and Importers;

• g)

  Transporters; and, h) Others.

This Regulation is mandatory throughout the entire national territory and its objective is to establish and standardize the procedures, activities, criteria, strategies, and operational techniques based on risk analysis that determines the prevention, control, and eradication actions of Avian Influenza, Newcastle Disease, Infectious Laryngotracheitis in Poultry, and Avian Salmonellosis (S. Gallinarum and S. Pullorum) executed through the National Poultry Program (PAN).

The Commission for Sanitation and Safety of the Poultry Chain (CSICA) shall be the technical scientific body responsible for creating, analyzing, defining the guidelines, and establishing strategies for the compliance of the National Poultry Program (PAN), and SENASA shall be the official entity responsible for compliance with the provisions emanating from this regulation.

The monitoring for the application of the provisions emanating from this Regulation shall be the responsibility of SENASA or through authorized entities of Veterinary Physicians based on what is established in the Phyto-zoosanitary Law or the corresponding Regulation on Authorization of Third Parties.

With regard to wild birds (birds in captivity), SENASA shall determine the species that for technical reasons it deems necessary to subject to epidemiological surveillance.

The National Poultry Program (PAN) shall be of a permanent nature with the purpose of keeping the country free of diseases of high economic impact, and if a change in status should occur, SENASA shall be responsible for the execution and coordination of public and private inter-institutional activities necessary to undertake the actions of control and eradication of the disease. CHAPTER II COMPONENTS OF THE PROGRAM

The PAN shall have the following components: a) Coordination b) Administration c) Registry and Statistics d) Field Operations e) Dissemination and Training f) Epidemiological Surveillance/Risk Analysis in the evaluation of biosecurity g) Laboratory Diagnosis h) Information Technology and Technologies of Information i) Sanitary Campaigns j) Technical Assistance The described components shall be executed by personnel appointed or authorized by SENASA, through the Technical Directorate of Animal Health for this purpose.

The activities and procedures for the execution and operation of the components of the PAN shall be established in the corresponding regulations, protocols, operation manuals, and procedures.

The Program shall guide epidemiological surveillance in poultry, such as breeders, reproducers, laying hens, broilers, raising, ornamental, fighting birds, backyard poultry, wild birds, and others; in the event a outbreak occurs in such birds, the control and eradication of the disease shall be proceeded with. CHAPTER III PROGRAM ACTIONS

The PAN shall strategically develop prevention, control, and eradication actions of avian diseases by implementing the following activities: a) Prevention and Control: 1. Monitoring on farms, backyard poultry, ornamental and fighting birds at the national level. 2. The evaluation of biosecurity programs and the implementation of risk mitigation in biosecurity improvement plans that shall be evaluated and audited by the PAN. 3. Epidemiological surveillance system based on information emanating from field data and laboratory results. 4. Infrastructure and diagnostic service. 5. Training plan, promotion, and sanitary education. 6. Development of Characterization and Georeferencing of poultry units. 7. Verification of the sanitary status of farms and communities. 8. Control of disease outbreaks or foci. 9. Vaccination. 10. Establishment of quarantines. 11. Cleaning and disinfection. 12. Others. b) Eradication: 1. Monitoring on farms, backyard poultry, ornamental, fighting birds, and others at the national level. 2. Epidemiological surveillance system based on information emanating from field information and laboratory results. 3. Infrastructure and diagnostic service. 4. Training plan, promotion, and sanitary education. 5. Verification of the sanitary status of farms and communities. 6. Eradication of disease outbreaks or foci. 7. Vaccination. 8. Establishment of quarantines. 9. Sanitary slaughter of poultry population. 10. Cleaning and disinfection. 11. Sentinelization in the focal area. CHAPTER IV DIAGNOSIS

Official veterinary medicine professionals, as well as those in private practice who have SENASA authorization to engage in activities related to the PAN, must inform it of the clinical diagnosis or suspicions of the presence of avian diseases within 24 hours following knowledge of the presence of an outbreak or clinical manifestations that would arise from the appearance of a disease.

The diagnosis of avian diseases with the official tests of the 4 diseases under official control may be performed only by official laboratories and those authorized by SENASA. These are obligated to inform the PAN, within a minimum period of 24 hours, when positive serology, positive PCR, viral isolation, or bacteriological isolation is detected.

The PAN shall establish and authorize the diagnostic tests necessary that shall be performed by the official laboratories and authorized private laboratories for the establishment of avian sanitary status. CHAPTER V QUARANTINE MEASURES

The Technical Directorate of Animal Health, through the PAN, may apply quarantine measures on farms or poultry flocks of backyard poultry at the appearance of an outbreak or focus of avian disease when it deems it appropriate. CHAPTER VI RISK ANALYSIS IN THE EVALUATION OF BIOSECURITY AND THE IMPLEMENTATION OF RISK MITIGATION

The evaluation of poultry biosecurity based on risk analysis shall be applied for the authorization and registration of farms for breeder operations, hatcheries, broiler or layer farms, expansions, upgrades, changes in zootechnical purpose, and distributors, which allows for the identification of risk factors, estimation of their impact, and applicable biosecurity mitigation measures in poultry operations.

In the evaluation of poultry biosecurity, consideration shall be given to the physical location of the farm and its environment (physical biosecurity), farm design (structural biosecurity), and the set of sanitary practices (analytical, operational, and epidemiological biosecurity) designed to prevent the entry, transmission, and spread of pathogenic agents that affect the health, production, productivity of birds, and the country's economy.

Every poultry production unit, hatchery, and distributor shall establish a plan and biosecurity measures which shall be subject to audits by the PAN for evaluation based on risk factors of the introduction and exposure to diseases. The poultry establishment shall commit to complying with a biosecurity plan that involves the development, implementation, and monitoring of a biosecurity plan as established in the PAN biosecurity manual.

The PAN shall conduct audits and monitoring of biosecurity measures and improvement plans in poultry production units, which shall be mandatory and must be complied with by the poultry establishment, with the advice of a Veterinary Surgeon or accredited Veterinary Surgeon, under the supervision of official Veterinary Surgeons; should it be found that these have not been complied with, this shall be grounds for the sanctions established in this agreement.

The Technical Directorate of Animal Health, through the PAN, shall inform the owners and Veterinary Surgeons of the poultry production units of the biosecurity evaluation measures through a specific manual.

Official, Authorized, and Advisory Veterinary Surgeons shall be subject to and must comply with the biosecurity measures established within the framework of the PAN to conduct their visits and provide the corresponding technical assistance.

The Risk Analysis applied to the evaluation of biosecurity and the biosecurity conditions that poultry operations must comply with for their registration shall be determined by the protocols used by the National Poultry Program in accordance with the technical and scientific guidelines established by the World Organisation for Animal Health (OIE) and in the Agreement on Sanitary and Phytosanitary Measures (SPS) of the World Trade Organization (WTO), giving rise to a documented decision-making process.

The evaluation of biosecurity measures in breeder farms, hatcheries of genetic material, day-old chicks or replacement birds, must obtain 90 points or more in their evaluation; otherwise, they may not be registered or obtain their renewal with the PAN, in addition to other factors considered in the evaluation of qualitative risk analysis regarding their biosecurity.

The evaluation of biosecurity measures for commercial layer farms, broilers, turkeys, and fighting birds must obtain 70 points or more in their evaluation; otherwise, they may not be registered or obtain their renewal with the PAN, in addition to other factors considered in the evaluation of qualitative risk analysis regarding their biosecurity.

Commercial layer farms, broiler operations, turkeys, and fighting birds that score less than 70 points in the biosecurity evaluation shall present to the PAN a management plan for biosecurity measures which must be endorsed by an Advisory Veterinary Surgeon or Authorized Veterinary Surgeon in order to be registered with the PAN or to proceed with their renewal procedures.

The management plan for biosecurity measures shall establish the compliance period which, in the case of breeder operations, hatcheries of genetic material, day-old chicks, or replacement birds, shall not exceed three months, and in the case of commercial layer farms, broilers, turkeys, and fighting birds, shall not exceed one year, and shall be approved by the PAN in order to proceed with its registration or renewal process. Said improvement plan shall have its compliance audited by the PAN; non-compliance with the commitments acquired for biosecurity improvement shall be grounds for suspension of registration with the National Poultry Program.

The control of internal movement of birds, their products, by-products, waste, inputs, equipment, and other items shall only be carried out in the event of a sanitary emergency. The Technical Directorate of Animal Health, through the PAN, shall establish measures for controlling the movement.

The Technical Directorate of Animal Health, through the PAN, shall establish measures for quarantine control of poultry products and by-products at ports, airports, and border checkpoints in order to prevent the introduction of exotic diseases into the country.

The personnel designated to carry out the sanitary activities of the PAN may conduct seizures, elimination, and destruction of poultry products and by-products that enter the country illicitly and that represent a high risk for national poultry farming.

Poultry farmers, including those engaged in backyard poultry farming, are obligated to comply with the technical recommendations established by the PAN regarding authorized vaccination programs for the prevention of specific avian diseases.

Epidemiological surveillance shall have the objective of demonstrating the absence of infection or infestation, determining the presence or distribution of an infection or infestation, or detecting as early as possible the presence of diseases, facilitating their control and providing the necessary data for risk analysis. Every productive unit is subject to epidemiological surveillance by the National Avian Program; refusal to submit to this process shall result in the sanctions established in this agreement.

The Technical Directorate of Animal Health through the PAN shall conduct epidemiological surveillance of avian diseases, for which it may coordinate and work jointly with the private poultry sector, through the Commission for Health and Food Safety of the Avian Chain (CSICA), which shall be subject to analysis to reinforce or establish new strategies in the PAN.

The Technical Directorate of Animal Health through the PAN shall submit the information of the Avian Program to the National System of Traceability and Agricultural, Aquaculture and Fisheries Registry (SINART), which will allow the inference through its data of the proposal of new strategies when deemed appropriate, for which it may rely on institutions of the public and private sector.

The PAN shall incorporate into the SINART computer platform the data of specialized, semi-specialized, artisanal, backyard poultry production units and others that are considered relevant.

The PAN shall establish a training plan directed at different levels of poultry operation in basic concepts of disease prevention, control, eradication and management of biosecurity measures. CHAPTER X NOTIFICATION

The Official Veterinarian or one Authorized by the National Service of Agricultural Food Health and Safety shall notify or inform the PAN with the frequency required by it, of the sanitary activities carried out in the production unit under its charge and of the results of the diagnostic tests that it has performed. In case of the outbreak of diseases subject to mandatory reporting, it must inform immediately and in writing.

The diagnostic laboratory authorized by SENASA shall inform the PAN monthly on the performance of diagnostic tests conducted. In case of a positive diagnosis of a mandatory notification avian disease, it must inform the PAN within forty-eight (48) hours following its detection.

The poultry producer is obligated to report to the PAN any event or occurrence that has relation to or sanitary importance in the control and eradication of avian diseases. CHAPTER XI LOCATION OF POULTRY OPERATIONS, HATCHERIES AND FACILITIES FOR THE PROCESSING OF POULTRY LITTER AND HEN MANURE BASED ON RISK ANALYSIS

The provisions relative to this chapter shall be applicable to poultry operations, hatcheries and fighting bird operations of new operation; before their installation or construction they must request approval from SENASA, which shall issue a ruling taking into consideration the risk analysis taking into account all interrelated factors.

Based on risk analysis, SENASA through the PAN may establish areas and zones not suitable or suitable for the approval of new productive units and hatcheries, derived from the evaluation of risk factors.

SENASA shall delimit the areas designated for planned and orderly growth (poultry production) as well as the areas that serve as biosecurity barriers or buffering, based on Risk Analysis taking into account the dynamics of poultry production.

When natural or legal persons dedicated to poultry production wish to make expansions to their installations or modifications to the registration, they shall request approval from SENASA, which shall issue a ruling taking into consideration the level of risk in accordance with what is established in Chapter VI of this Agreement, that said expansion or modification could represent, for which they must be submitted to a technical ruling.

Different farms of the same zootechnical function belonging to the same owner may operate and be registered under the concept of modules on the same property. Companies that wish to expand their operations shall request the expansion under the module concept.

Regarding the location of farms: The established distances may be modified based on the dominant winds existing in the area, the topography of the land, natural barriers and other epidemiological factors, through qualitative risk analysis of the biosecurity evaluation.

Location of breeder, reproducer farms and facilities for the processing of poultry litter and hen manure based on risk analysis:

• a)

  Breeder and reproducer farms must be located at a distance of two (2) kilometers between farms of the same type; in the case of rearing farms of the same company, they may be located on the same property, but in different modules with independent biosecurity management. The established distances may be modified based on the dominant winds existing in the area, the topography of the land and other epidemiological factors, through qualitative risk analysis of its biosecurity programs, conducted by SENASA-PAN.

• b)

  Hen manure and poultry litter processing plants must comply with the distance of two (2) kilometers from this type of operation; the established distances may be modified based on the dominant winds existing in the area, the topography of the land and other epidemiological factors, through Qualitative risk analysis of its biosecurity programs, conducted by SENASA-PAN.

• c)

  Commercial layer farms, broiler chickens, fighting birds must comply with the distance of two (2) kilometers from this type of operation.

• d)

  For the registration of poultry establishments of this category, they must comply with a Qualitative Risk Analysis of their Biosecurity programs by SENASA-PAN, as established in Chapter VI.

Location of commercial laying farms, broiler chickens, fighting birds, processing plants, turkeys and replacement birds and byproduct plants for poultry litter and hen manure based on risk analysis: a) Among commercial laying farms, broiler chickens, processing plants, turkeys and replacement birds, distances shall be located at one and a half (1.5) kilometers apart from one another. In the case of breeding farms of the same company, they may be located on the same property, but in different modules with independent biosecurity management. The established distances may be modified based on the prevailing winds existing in the area, the topography of the terrain and other epidemiological factors, through Qualitative risk analysis of their biosecurity programs, conducted by SENASA-PAN b) Byproduct plants of poultry litter and hen manure must comply with a distance of two (2) kilometers from this type of operation. The established distances may be modified based on the prevailing winds existing in the area, the topography of the terrain and other epidemiological factors, through Qualitative risk analysis of their biosecurity programs, conducted by SENASA-PAN. c) The installation of an avicultural operation shall not be permitted at a minimum distance of one (1) kilometer from Processing Plants (Slaughtering or Sacrifice). d) For the registration of avicultural establishments in this category, they must comply with a Qualitative Risk Analysis of their Biosecurity programs by SENASA-PAN, as established in Chapter VI.

The installation of an avicultural operation shall not be permitted at a minimum distance of one (1) kilometer from a balanced feed plant that complies with current regulations of the Technical Directorate of Animal Health, Department of Veterinary Products and the Agroalimentary Safety Directorate. The location of balanced feed plants and processing plants within the property of the same farm shall be permitted only for self-supply purposes and provided that it complies with current regulations of the Technical Directorate of Animal Health, Department of Veterinary Products and the Agroalimentary Safety Directorate.

Location of Incubation Plants, in risk analysis:

• a)

  Incubation plants shall be located at a distance of one (1) kilometer between one incubation plant and another and other types of independent farms. The established distances may be modified based on the prevailing winds existing in the area, the topography of the terrain and other epidemiological factors, through qualitative risk analysis of their biosecurity programs, conducted by SENASA-PAN.

• b)

  Byproduct plants, poultry litter and hen manure plants must comply with a distance of one (1) kilometer from this type of operation. The established distances may be modified based on the prevailing winds existing in the area, the topography of the terrain and other epidemiological factors, through Qualitative risk analysis of their biosecurity programs, conducted by SENASA-PAN.

• c)

  The installation of an incubation plant shall not be permitted at a minimum distance of one (1) kilometer from Processing Plants (Slaughtering or Sacrifice).

• d)

  For the registration of avicultural establishments in this category, they must comply with a Qualitative Risk Analysis of their Biosecurity programs by SENASA-PAN, as established in Chapter VI.

With the exception of those engaged in backyard poultry farming, any person interested in the installation of an Avicultural Production unit, incubator, poultry litter and hen manure processing plants shall submit to a two-stage process: 1. Property Authorization. 2. Farm registration to the National Avicultural Program. These may be presented in the same application. In the Property Authorization stage for the construction of avicultural establishments, sanitary risks that may arise in the installation of a new operation shall be evaluated through field inspection. Backyard poultry is understood to mean: a group of birds raised in the yards of houses in rural or urban areas without management practices or biosecurity. Commercial poultry is understood to mean: groups of birds raised in confinement with established management and biosecurity practices.

To request Property Authorization for the installation of any Avicultural Production Unit, breeding, incubator, poultry litter and hen manure processing plant and fighting bird facility before the PAN of SENASA, the interested party must submit a request to the General Secretariat which must contain: a. Request addressed to the General Secretariat containing: name of the owner or the company, exact location of the property, indicating the village, municipality and department, the type of production intended to be registered and the quantity of birds and tons of organic matter to be processed in the case of poultry litter and hen manure processing plants or present authenticated promise of purchase/sale in case the property is in the process of acquisition b. Submit articles of incorporation of the partnership or declaration of individual merchant. c. Deed of purchase and sale duly registered with the Property Institute, in case of being owner of the property for which registration is requested and in case of being a lessor, present a lease agreement accompanied by the deed of purchase and sale duly registered with the Property Institute. d. Certificate from the Environmental Management Unit of the locality that it is not located in a protected area. e. Payment of service fees.

The Coordination of the National Avicultural Program shall order field inspection by technical personnel of the PAN/SENASA, applying the inspection formats for registration and georeference of properties and within the period of thirty (30) business days counted from the date of the order of admission shall prepare the corresponding Technical Reports and issue the technical opinion, recommending with justification whether or not the request of merit is approved.

Once the field studies have been conducted and the corresponding technical opinions have been issued, the file shall be forwarded to the SENASA Legal Directorate so that within the period of five (5) business days counted from the date it receives the file, it shall proceed to issue a legal opinion in accordance with current legislation.

In case the opinion is favorable for property authorization for installation of Avicultural Production Units, incubators, poultry litter and hen manure processing plants and fighting bird establishments: A period of six months shall be granted for the construction of the farm; if the designated period expires, written request must be made for an extension of this, for a maximum of six more months, with the warning that if not done so, the file shall be archived without further proceedings, losing the right of preference of authorization of said property in front of an interested third party. In qualified cases, the validity of the property authorization may be extended for more than 1 year, provided that the applicant demonstrates that it is in the process of financing or construction of its avicultural operation.

Once construction and/or installation work of Avicultural Production Units, incubators, poultry litter and hen manure processing plants and fighting bird establishments is completed, the owner or their Legal Representative must notify SENASA to proceed with registration to the National Avicultural Program in the same proceeding in which they requested Property Authorization.

To request registration to the National Avicultural Program of any Avicultural Production unit, incubator and poultry litter and hen manure processing plants, before the General Secretariat of SENASA, the interested party must comply with the following requirements: For the registration of avicultural establishments to the National Avicultural Program, they must comply with biosecurity management measures and/or qualitative risk analysis of biosecurity conducted by SENASA-PAN. a. Request before SENASA which must contain: name of the owner, name of the company, exact location of the company, indicating the village, municipality and department, the type of production intended to be registered, the quantity of birds. b. Certificate from the Environmental Management Unit of the locality that it is not located in a protected area. c. Submit articles of incorporation of the partnership. d. Deed of purchase and sale duly registered with the Property Institute, in case of being owner of the property for which registration is requested and in case of being a lessor, present a lease agreement accompanied by the deed of purchase and sale duly registered with the Property Institute. e. Payment of service fees. In case of joint requests for authorization and registration of farms, the interested party shall only provide as additional information, the current operating permit. In the case of fighting bird establishments, whatever the quantity of birds it has, the interested party must comply with the following requirements:

• a)

  Request before SENASA and must contain: name of the owner, name of the company, exact location of the company, indicating the village, municipality, department and the quantity of birds.

• b)

  Certificate from the Environmental Management Unit of the locality that it is not located in a protected area.

• c)

  Declaration of individual merchant or articles of incorporation of the partnership.

• d)

  Deed of purchase and sale duly registered with the Property Institute, in case of being owner of the property for which registration is requested and in case of being a lessor, present a lease agreement accompanied by the deed of purchase and sale duly registered with the Property Institute.

• e)

  Payment of service fees.

The General Secretariat of SENASA, through the coordination of the National Avicultural Program, within ten (10) business days following the submission of the registration request, by means of an order of admission, shall order the Coordination of the National Avicultural Program to issue the corresponding Technical opinion.

The Coordination of the National Avicultural Program shall order inspection in order to conduct the biosecurity audit. To obtain registration or renewal of registration, the applicant must comply with biosecurity management measures for qualitative risk analysis of biosecurity conducted by SENASA-PAN.

Subsequently, the file of merit shall be sent to the SENASA Legal Directorate so that said Directorate within the period of ten (10) business days counted from the date it receives the file, shall issue the corresponding Legal Opinion.

The General Directorate of SENASA, after thirty (30) business days have elapsed since the request was submitted and the technical and legal opinions have been issued, by means of an order shall give course to the proceedings of merit, issuing the respective resolution within a period of five (5) business days after having received the corresponding opinions.

The validity of the Certificate of Registration and Registration Renewal shall be five (5) years.

In the event that the registration application is declared without merit, the General Direction of SENASA shall order the initiation ex officio of the administrative procedure to establish liability against the owners of poultry farms that are operating without their respective registration, imposing in its case the fines and sanctions established for such purposes in this Regulation.

To request the Renewal of registration in the National Poultry Program of all Poultry Production Units, hatcheries, pollinaza and gallinaza processing plants, a request shall be submitted sixty (60) calendar days in advance before the General Secretariat of SENASA and the interested party must accredit the following documentation:

• 1)

  2 biosecurity measures audits from the last year with intervals of six months, certifying compliance with improvement plans from the last year. In the event that the audits indicated are not available, technical inspection shall be carried out by the PAN or authorized third parties.

• 2)

  Authenticated or certified photocopy of the registration certificate about to expire.

• 3)

  Receipt of payment of the service fee.

  In the case of fighting bird establishments, the interested party in lieu of what is established in numeral 1) must present 2 diagnostic results from laboratory tests of the four diseases subject to official control with an interval of six months. Having complied with the requirements indicated, the renewal of registration shall be issued by the General Direction.

To request registration in the National Poultry Program of Distributors of day-old chicks, before the General Secretariat of SENASA, the interested party must comply with the following requirements:

• a)

  Application with SENASA which must contain: Full name of the owner, name of the company, exact location of the company indicating the village, municipality and department, number of birds to distribute, telephone number and email address of the owner.

• b)

  Authenticated or certified photocopy by the General Secretariat of SENASA of the partnership incorporation deed or declaration of individual merchant.

• c)

  List of clients and attached their valid registration certificate.

• d)

  Contract or certificate proving the origin of the birds to be distributed.

• e)

  Current operating permit from the municipal mayor's office.

• f)

  Commitment deed not to sell birds to persons or companies not registered in the National Poultry Program.

• g)

  Copy of the owner's identification.

• h)

  RTN of the company or the owner. Chick distributors must maintain a sales log. Said log must contain the name of the farm, owner and monthly quantity of product supplied, which must be maintained at the Distributor's facilities and made available to official inspectors when requested. Infractions committed by distributors shall be sanctioned in accordance with the fine stratification table.

To request renewal of registration in the National Poultry Program of Distributors of one-day-old chicks, a request shall be submitted sixty (60) calendar days in advance before the General Secretariat of SENASA and the interested party must accredit the following documentation:

• a)

  Application with SENASA which must contain: Full name of the owner, name of the company, exact location of the company indicating the village, municipality and department, number of birds to distribute, telephone number and email address of the owner.

• b)

  Authenticated or certified photocopy by the General Secretariat of SENASA of the registration certificate about to expire.

• c)

  List of clients and attached their valid registration certificate.

• d)

  Contract or certificate proving the origin of the birds to be distributed.

• e)

  Current operating permit from the municipal mayor's office.

• f)

  Commitment deed not to sell birds to persons or companies not registered in the National Poultry Program.

• g)

  Receipt of payment of the service fee. CHAPTER XIV MODIFICATION OF REGISTRATION

The registration of any poultry production unit may be modified for the following reasons: 1) Change of owner or business name. 2) Increase in installed population capacity 3) Change of zootechnical function. The modification procedure shall be carried out through simple notification addressed to the National Poultry Program, which shall refer it to the Legal Advisory Department and once analyzed, the respective resolution shall be issued to proceed with the modification of the Registration Certificate. The petitioner must attach to their request the documents that prove the reasons for the modification.

EXPANSION OF REGISTRATION. - When a farm registered in the National Poultry Program wishes to distribute replacement birds of 18 weeks and older, it must request registration expansion from SENASA when it intends to modify the item of its activities, for which its initial registration has been granted, for which it must present the following requirements: a) Request addressed to the Secretary of SENASA. b) List of clients and the valid registration certificate in case the client is a poultry farm.

The approval of the registration expansion shall be subject to verification by the Technical Direction of Animal Health through the National Poultry Program and compliance with the requirements established in the applicable SENASA regulations.

The registration shall have the same validity as the original registration.

Distributors of replacement birds of 18 weeks shall maintain a sales log. Said log must contain the name of the farm and name of the owner, name of the association and the name of its legal representative or natural person and the monthly quantity of product supplied, which must be maintained at the Distributor's facilities and made available to official inspectors when requested. CHAPTER XV SUSPENSION AND CANCELLATION OF REGISTRATION

SENASA through the National Poultry Program may order the suspension of registration to farms that have a valid registration, for the following reasons: a. Failure to comply with the action plan for biosecurity improvements, regarding deficiencies that had been notified to them within the specified period. b. Failure to allow entry to official technicians of the National Poultry Program and accredited parties, to perform ex officio activities. The suspension shall be from six months to one year.

SENASA through the National Poultry Program may order the cancellation of registration to farms that have valid registration, for the following reasons: a. Having abandoned the poultry operation for two (2) consecutive years

Any Poultry Production Unit, hatchery, pollinaza and gallinaza processing plant and fighting bird establishment to which registration in the National Poultry Program has been suspended: The issuance of import and export certificates for birds and products of poultry origin by SENASA shall be suspended and the purchase of replacement birds in the national territory shall be prohibited. CHAPTER XVI INVESTIGATION PROCEDURE FOR INFRACTIONS OF THE PHYTOZOOSANITARY LAW AND THIS REGULATION

The National Service for Sanitation and Agrifood Safety through the Coordination of the National Poultry Program shall investigate infractions committed against the Phytozoosanitary Law and this Regulation, whether ex officio or by complaint and shall maintain an entry log in which the corresponding entry shall be made of the investigations initiated, granting a consecutive entry number, type of request, place, date and time of submission and the name of the interested party or of whoever appears in their representation, in case a complaint has been filed; or the designation of having initiated the procedure ex officio as the case may be.

Within five (5) business days following the entry recording in the corresponding log, the General Secretariat of SENASA, by means of an admission order, to investigate what was denounced, shall proceed to order the Coordination of the National Poultry Program to issue such technical reports as it deems appropriate, that the technical inspections be carried out that are necessary, the georeference and biosecurity evaluation

of the units of poultry production, hatcheries, pollinaza and gallinaza processing plants and fighting bird establishments, infringer, and that all documentation related to it be attached to the case file.

In the same order it shall also order that the owner of the farm or their Legal Representative be cited, so that they may know of the complaint and of the procedure that has been initiated, so that they may exercise the rights and guarantees granted to them by law.

When the complaint is declared well-founded, the Director shall impose on the defendant the sanctions that correspond according to law, being able to enforce administratively through the method of compulsion, or with the assistance of public force those that are of immediate enforcement and shall grant a period for compliance with sanctions that are not, if it can execute those of immediate enforcement or the defendant fails to comply with the period granted to comply with the sanctions that are not of immediate enforcement imposed in the resolution issued, SENASA shall remit the merit file to the Attorney General of the Republic and to the Public Ministry, so that it promotes through the judicial route against the defendant, the corresponding administrative, civil and criminal actions. CHAPTER XVII PROCEDURE FOR CLOSURE OF ESTABLISHMENTS

In the Administrative Resolution in which the total closure of the establishment is ordered in accordance with what is stipulated in Article 82, subsections a), b), d) and e) of this Regulation, all necessary mechanisms and measures shall be provided so that the owner of the Farm, poultry farming operation or cockfighting establishment committing the infraction takes safeguard measures for the birds or any other perishable product that it has in the establishment at the moment this measure is executed, granting a period for its liquidation which shall be recommended by the Coordination of the National Poultry Program.

In the event that the owner of the Farm, poultry farming operation or cockfighting establishment committing the infraction does not comply with the measures ordered by SENASA within the granted period, by means of a reasoned ruling shall order the slaughter or destruction of the birds or any other perishable product that it has in the establishment and shall proceed to forced closure execution. SENASA shall remit the merit file to the Attorney General of the Republic and to the Public Ministry, so that, through the judicial route against the defendant, the corresponding civil and criminal actions shall be instituted. CHAPTER XVIII OF REMEDIES

Against the Resolutions issued by the Director General of the National Service of Sanitation and Agroalimentary Safety, the Remedy of Reconsideration is available as established by the Administrative Procedure Law, and with this remedy the administrative remedy is exhausted. CHAPTER XIX AUTHORIZATION OF THIRD PARTIES

Veterinary Medicine professionals who meet the requirements established in the SENASA Third Party Authorization Regulation, to which Articles 25 and 26 of the current Phytozootechnical Health Law created by Legislative Decree Number 157-94 and amended by Legislative Decree Number 344-2005, shall be able to execute one or more activities within the framework of the National Poultry Program for the Prevention of Avian Diseases.

Private Diagnostic Laboratories that meet the requirements of the Accreditation Regulation referred to in the previous Article approved by SENASA shall be able to issue results of viral isolation and identification in the verification of flocks, farms or companies subject to the Newcastle Disease Prevention, Control and Eradication Program. CHAPTER XX MANAGEMENT OF BIOSECURITY MEASURES FOR THE REGULATION OF COMMERCIAL LAYING AND BROILER POULTRY ESTABLISHMENTS AT THE NATIONAL LEVEL

Every existing production unit must have current registration in the National Poultry Program.

Every new production unit must be enrolled in the National Poultry Program of SENASA, without prejudice to other requirements that must be complied with for its full operation.

The National Poultry Program of SENASA shall maintain control through information provided by legally established associations of every batch or flock that enters as replacement in a poultry production unit.

The delivery of one-day-old chicks, replacement chicks and the culling of laying birds must be reported by the hatcheries and production units to the PAN, which in coordination with the Sanitation and Safety Commission of the Poultry Chain (CSICA), shall define the relevant and adequate mechanisms for follow-up to guarantee compliance with sanitary regulations and the definition of epidemiological surveillance strategies.

As a risk mitigation measure, the recommended maximum age for the culling of laying birds shall be 120 weeks.

Production units, at the moment of replacing batches or flocks of laying birds, shall carry out a sanitary break of at least 3 weeks of the corresponding batch or flock.

Hatcheries at the national and international level in order to carry out the commercialization of their female chicks and male chicks must be certified by SENASA and registered in the National Poultry Program.

Every production unit must have a Vaccination program prepared and supervised by a licensed veterinarian and approved by the National Poultry Program of SENASA.

Poultry production units with populations above 10,000 birds must have the services of a licensed Veterinarian as a Technical Advisor, or of a veterinarian outsourced by SENASA.

In all commercial laying production units, the reuse of bedding shall not be permitted.

Every production unit for its commercialization stage shall have: a. Table eggs: GMP, GAPs, evaluated by SENASA b. Culled birds: May be commercialized for human consumption, fresh food for pets, or as raw material in the form of meal for the elaboration of balanced feeds, being in both cases processed in a plant approved by SENASA. c. Chicken meat: May be commercialized for human consumption, fresh food for pets, or as raw material in the form of meal for the elaboration of balanced feeds, being in both cases processed in a plant approved by SENASA. d. Poultry litter and broiler litter: For this to be commercialized, it must be subjected to physical, chemical, or biological treatments that prevent the spread of pathogenic agents.

Every production unit for the movement of live birds from the farms to processing plants must carry its registration sheet containing information about the origin of the birds and their destination.

For the distribution of day-old pullet chicks and broiler chicks, replacement birds (18 weeks and older), of light breeds or commercial laying birds, the following requirements must be met:

• a)

  National-level hatcheries to carry out the commercialization of pullet chicks and broiler chicks must be registered in SENASA's National Poultry Program. International hatcheries to carry out the commercialization of pullet chicks and broiler chicks must comply with the admissibility process established by SENASA.

• b)

  The distributor of replacement birds more than one day old must register in the National Poultry Program and must prove the origin of the replacement birds being distributed.

• c)

  The biosecurity measures of breeders and hatcheries must score 90 points or higher in their biosecurity evaluation; otherwise, they cannot be registered or obtain their renewal to the PAN. Neither can they obtain import permits for replacement pullet chicks or fertile eggs.

For the delivery of day-old pullet chicks and broiler chicks, replacement birds (18 weeks) of light breeds or commercial laying birds, the following requirements must be met:

• a)

  They may be delivered solely and exclusively to farms duly registered in the national poultry program with current registration.

• b)

  They may be delivered solely and exclusively to distributors duly registered in the National Poultry Program with current registration.

• c)

  Every commercial laying production unit upon completion of its productive cycle established in this regulation, for the movement of live birds from the farm to processing plants or slaughterhouses must carry its registration sheet containing information about the origin of the birds and their destination.

The National Poultry Program, in its capacity as executor of SENASA, in order to achieve its objectives, may coordinate actions with other public or private institutions, national or international.

The following are considered Minor Infractions:

• a)

  Failure to comply with biosecurity improvement plans in the 2 annual audits conducted by the National Poultry Program that do not put the health status at risk.

• b)

  Failure to send reports requested by SENASA for monitoring of the National Poultry Program.

• c)

  Failure to have procedures for waste management in accordance with the provisions of this Regulation.

• d)

  Change of production activity without prior authorization from SENASA.

The following are considered Less Serious Infractions:

• a)

  Recurrence in the commission of a minor infraction.

• b)

  Failure to request approval of any expansion of facilities to the PAN.

• c)

  Operating with expired registration.

The following are considered Serious Infractions:

• a)

  Failure to be registered with the National Poultry Program PAN.

• b)

  Failure to comply with the location provisions established in article 46 of this regulation for the installation of breeder farms, reproductive farms, and specific pathogen-free farms.

• c)

  Failure to comply with the location provisions established in article 47 of this regulation for the installation of commercial laying farms, broiler chickens, turkeys, and replacement birds and other provisions contained in this regulation.

• d)

  Failure to comply with the location provisions established in article 49 of this regulation for the installation of hatchery plants and other provisions contained in this regulation.

• e)

  Falsification or alteration of zoosanitary certifications, verification records, laboratory results, and other official zoosanitary documents.

• f)

  Obtaining birds from illegal sources.

• g)

  Failure to comply with regulations issued for the registration of origin and destination of live birds.

• h)

  Purchase or sale of birds to establishments not authorized and registered in the Poultry National Program (PAN), purchase of birds whose origin cannot be verified.

The sanction applied for infraction of a Minor Infraction shall be: written warning and payment of a fine in accordance with the Fine Stratification Table by number of birds.

The sanction applied for infraction of a Less Serious Infraction shall be: written warning and payment of a fine in accordance with the Fine Stratification Table by number of birds.

Serious infractions shall be sanctioned as follows: The sanction applied for infractions contemplated in subsections e), f), g), and h) of article 99 of this Regulation: written warning and payment of a fine in accordance with the Fine Stratification Table by number of birds. The sanction applied for infractions contemplated in subsections a), b), c), and d) of article 81 of this Regulation: written warning, payment of a fine in accordance with the Fine Stratification Table by number of birds, and definitive closure of the establishment. Recurrence of a minor or less serious infraction shall give rise to the imposition of the next higher sanction. Payment of a fine in accordance with the Fine Stratification Table by number of birds and definitive closure of the establishment. Recurrence of a minor or less serious infraction shall give rise to the imposition of the next higher sanction.

Poultry production units that as of the date of publication of this Agreement have submitted registration applications or are operating and do not comply with the provisions established in this Regulation may request their registration or registration renewal by submitting to high biosecurity standards, with a minimum score of ninety (90) percentage points of the protocol for the evaluation of biosecurity measures of the National Poultry Program. The National Poultry Program shall grant a maximum period of one (1) year to achieve the minimum score of ninety (90) percentage points. During the process of compliance with biosecurity standards imposed by the PAN, the farm may operate with temporary registration. After the granted term, without having achieved the minimum required score, the registration application shall be denied. This provision shall not be applicable to new facilities that arise after the publication of this Regulation.

The PAN is empowered to implement emergency sanitary measures for the control and eradication of endemic and exotic poultry disease outbreaks.

The PAN shall develop the technical procedure manuals required for the prevention, control, and eradication of poultry diseases.

SENASA shall provide the financial resources necessary for the operation of the PAN, as well as the management of other financial resources from either national or international institutions linked to the poultry sector.

Agreements C.D.- SENASA-007-2018 containing the Regulations of the National Poultry Program and C.D.-SENASA-007-2019 containing modifications to the Regulations of the National Poultry Program, Agreement C.D. SENASA 007-2018, are hereby repealed.

This Agreement shall be effective as of its publication in the Official Gazette La Gaceta, April 22, 2022. Given in the city of Tegucigalpa, municipality of the Central District, on the third day of the month of May of the year two thousand twenty-two. COMMUNICATE AND PUBLISH.

X LAURA ELENA SUAZO President of the Board of Directors of SENASA X ROY LAZO Vice-Minister of Agriculture Alternate SAG X ANABEL GALLARDO PONCE Titular Board Member FENAGH X Hector Ferreria Sabillon Alternate Board Member FENAGH AGREEMENT C.D.SENASA 004-2022 HONDURAS GOVERNMENT OF THE REPUBLIC X JUAN JOSE CRUZ Alternate Board Member COHEP X LEONARDO SANCHEZ Alternate Board Member ARSA X Jose Angel Acosta Vice-Minister of Livestock Alternate SAG X ANGELO EMILIO AGUILAR MEJIA Executive Secretary of the Board of Directors