1
REPUBLIC OF COSTA RICA
Ministry of Agriculture and Livestock
SENASA
(National Service of Animal Health)
National Program of Residues
Residues Plan for Bovines
2014
______
Dr.Germán Rojas
Genera Director
SENASA
CONTENTS
1. SCOPE ……………………………………………………………………………...... / 32. INTRODUCTION …………………………………………………………………………...... / 3
3. LEGAL FRAMEWORK………………………………………………………………………… / 6
4.OBJECTIVE ………………………………………………………………………………………… / 7
5DEFINITIONS ……………………………………………………………………………………… / 8
6ABBREVIATIONS ……………………………………………………………………...... / 9
7RESIDUES MONITORING PLAN PARTICIPANTS ……………………………………………… / 9
8COMPETENT AUTHORITY ……………………………………………………………………….... / 9
9LABORATORIES ……………………………………………………………………...... / 10
10MEDICINES RESIDUES AND CONTAMINANTS TO BE MONITORED ………..……………. / 11
11SAMPLINGPROTOCOL …………………………………………………………….……………. / 13
12METHOD OF ANALYSIS…….………………………………...... …………..…. / 13
13INTERPRETATIONS OF RESULTS …...... / 13
14ACTIONS ...... ………………………………………………………………………………… / 14
15PENALTIES...... / 14
16ADMINISTRATIVE AND FINANCIAL ASPECTS...... / 15
17. APPENDIXES 1 Program 2013………………………………………………………………….. / 16
18. COMMENTS……………………………………………………………………………………….. / 18
19. COMPOUNDS TO BE MONITORED 2014…………………………………………………….. / 20
- SCOPE
The Residues Plan for Bovines identifies aspects related to the use and control of veterinary drugs and contaminants, as well as banned substances within the sphere of bovine products and byproducts for human consumption, to protect the health of consumers and facilitate the trade between countries.
- INTRODUCTION
This plan intends to offer a broad view of meat bovine cattle in order to characterize and analyze the production and marketing chain and be able to suggest action lines to optimize the participation of all strategic actors. This will be done in order to improve technological application to advance the benefits of the meat cattle industry and decrease the residues of veterinary drugs and contaminants.
The meat cattle industry has a relevant socioeconomic importance due to the magnitude or resources used, especially land (exclusively pasture), work labor and also for being a basic food supplier for local consumption and exports.
Currently, there are 50 014bovine exploitations registered in the Registration System for Livestock Establishments (SIREA). Table 1shows their distributionby regionin the country according to their production system.
Table 1. Number of bovine establishmentsperproduction system.
Table 1. Number of bovine establishments per production systemProduction system
Region / Beef / % / Dairy / % / Dual purpose / % / Total / %
Chorotega / 7.030 / 20,7 / 406 / 6,1 / 1.817 / 19,3 / 9.253 / 18,5
Pacífico Central / 2.230 / 6,6 / 99 / 1,5 / 292 / 3,1 / 2.621 / 5,2
Brunca / 7.140 / 21,1 / 1.084 / 16,2 / 1.333 / 14,1 / 9.557 / 19,1
Central Sur / 2.000 / 5,9 / 129 / 2,0 / 292 / 3,0 / 2.421 / 4,8
Central Occidental / 998 / 2,9 / 1.213 / 18,1 / 233 / 2,5 / 2.444 / 4,9
Metropolitana / 1.205 / 3,6 / 1.656 / 24,7 / 295 / 3,1 / 3.156 / 6,3
Huetar Norte / 7.402 / 21,8 / 1.707 / 25,5 / 4.430 / 47,0 / 13.539 / 27,0
Huetar Caribe / 5.884 / 17,4 / 398 / 5,9 / 741 / 7,9 / 7.023 / 14,0
Totals / 33.889 / 100 / 6.692 / 100 / 9.433 / 100 / 50.014 / 100
67,7% / 13,4% / 18.9%
Source: SENASA, SIREA, 2011
Beeffarmsaccount for 68% of all cattlefarmsin the country. Theyaremainly distributed inthe regions of Chorotega,BruncaandHuetar Norte, which together holdabout 64% of this typeoffarms.
Thedual-purposefarmsrepresent 19% of total bovineestablishments. TheHuetar Norte region hasalmost 50% ofthese farms, andChorotega and Bruncatogether have another 33% ofthem.
13% of bovineestablishments in the country are specialized dairyestablishments. They are mainly distributed in the regions of Huetar Norte, MetropolitanaandCentralOccidental, accountingfor 68% of the establishments of this type.
Table2 showsthe bovine populationperproduction systemregisteredin the SIREA, for a total of 1.863262 cattle. Beef cattlerepresent 65% ofthe population, whereas dairy cattle represent 13% of it, and dual-purpose cattle represent 22%.
Thebeefcattle populationis distributed throughoutthe whole country; however, 86% is concentrated in the regions of Chorotega,Brunca,HuetarNorte and HuetarAtlántica.
Distribution of dairy cattle population in the country is less uniform; Metropolitana region,CentralOccidental regionandHuetar Norte region make up over 80% of the country's dairy population.
Table 2. Bovine population per production systemProduction system
Region / Beef / % / Dairy / % / Dual purpose / % / Total / %
Chorotega / 347.500 / 28,6 / 23.936 / 9,8 / 94.087 / 23,3 / 465.523 / 25,0
Pacífico Central / 84.607 / 7,0 / 2.640 / 1,1 / 12.609 / 3,1 / 99.856 / 5,4
Brunca / 202.092 / 16,6 / 13.988 / 5,7 / 45.590 / 11,3 / 261.670 / 14,0
Central Sur / 42.341 / 3,5 / 1.340 / 0,6 / 8.998 / 2,2 / 52.679 / 2,8
Central Occidental / 22.606 / 1,9 / 39.288 / 16,1 / 7.252 / 1,8 / 69.146 / 3,7
Metropolitana / 23.242 / 1,9 / 56.718 / 23,2 / 7.109 / 1,7 / 87.069 / 4,7
Huetar Norte / 291.037 / 24,0 / 100.298 / 41,0 / 202.698 / 50,1 / 594.033 / 31,9
Huetar Caribe / 200.888 / 16,5 / 6.191 / 2,5 / 26.207 / 6,5 / 233.286 / 12,5
Totals / 1.214.313 / 100 / 244.399 / 404.550 / 100 / 1.863.262 / 100
65,2% / 13,1% / 21,7%
Source: SENASA, SIREA, 2011
TheHuetar Norte region holds 50% of the dual-purpose cattle population, while theChorotegaandBrunca regions together account foralmost 35% of it.
In terms of meat bovine cattle commercialization, it is performed mostly through auction systems, which can be found in every zone devoted to the cattle industry. There are 19 auction locations (Pomareda and Cordero, 2005). Slaughter facilities and supermarkets prefer to buy living cattle directly from medium and large producers and have their own buying infrastructure. However, during shortage times they participate actively as buyers on the auctions.
Concerning industrialization, more than 80% of the cattle in Costa Rica are processed in fourmainplants(Arreo, Coopemontecillos, Gicoand Del Valle).These establishments operate in compliance with all the international standards in regards to food safety, environmental impact control and animal well-being. Three of those facilities are certified by the United States Department of Agriculture (USDA) to export to that country (Arreo and Coopemontecillos).
In terms of local consumption, bovine meat is located at the second place with a per capita consumption of 14.1 kg in 2005, against a 21.1 kg per capita consumption of chicken (CORFOGA, 2005) and 9 kg consumption of pork.
- REFERENTIAL LEGAL FRAMEWORK
The legal framework used in Costa Rica pertaining to the sanitary control (health and safety) of all factors participating in the bovine production chain is executed by the National Service of Animal Health (SENASA by its Spanish acronym) as the Competent Authority, based on the following regulations:
3.1.SENASA Law n°8495 approved on May 16th of 2006, upon which main objectives are to regulate, plan, execute and carry out official activities of national, regional and international nature, related to animal population health, residues, veterinary public health, veterinary control of zoonosis, traceability,safety and protection of animal origin food, animal feed, veterinary drugs, animal genetic material, products and byproducts, production, use, release or commercialization of genetically modifiedorganisms that may affect animal's health or their environment and hazardous substances of animal origin. 1/ for that purpose, SENASA’s law establishes the responsible entity and it empowers it with the necessary competencies. 2/to facilitate its execution and functionality, the law was promulgated through the use of presidential decrees.
3.2.Executive Decreen°28861 and its reforms (Executive Decree n°29762)“Bylaws for the Registry and Control of Veterinary Drugs” published on August 12thof 2000, to regulate the registry, labeling and control of veterinary medicines and the entities involved in those procedures.
3.3.Executive Decreen°24401-MAG“Prohibition for the use of Nitrofurans and Furazolidone”.
3.4.Executive Decreen°27529-MAG“Acceptance of the Equivalence in Compliance of the Harmonized Registry Requirements for Pesticides and Veterinary Drugs”.
3.5.Executive Decreen°27773-MAG-MEIC-TSS“Prohibition of the use of Lindane and DDT isomers”.
- OBJECTIVE
4.1.General objective:
4.1.1.To establish the guidelines to carry out the Residues in Bovines Plan throughout the different phases of the bovines production chain, concerning residues of veterinary use, contaminants and banned substances of their products and byproducts for human consumption.
4.1.2.To contribute to the quality certification of products of animal origin for human consumption, both domestic and international.
4.2.Specific objectives:
4.2.1.To diagnose, prevent and control toxic residues and contaminants in food of animal origin.
4.2.2.To avoid or minimize the risk for human health represented by the presence of residues when found in amounts above those considered as safe for humans.
4.2.3.To count with available information that may facilitate decision-making, in order to minimize risks of the effects of drugs and contaminants in products or byproducts of animal origin for a human health.
- DEFINITIONS
5.1.Contaminant: any substance, not intentionally added to food that is present in food as the result of its production, preparation, treatment, canning or bottling, packaging, transportation or storage or as a result of environmental contamination.
5.2.Functioning minimum limits (MRPL): they are applicable to those substances that have not been assigned a permitted limit, particularly substances whose use has not been authorized.
5.3.Banned substance: pharmaceutical substance which administration is prohibited by the national legislation or by that of the destination markets.
5.4.Good practices in the use of veterinary drugs (BPMV): understood as the officially recommended and approved use, including withdrawal time approved by national authorities of veterinary drugs administered under practical conditions.
5.5.Illegal treatment: it includes the use of substances forbidden in animal treatments and doses of veterinary drugs in concentrations above those indicated by the manufacturers.
5.6.Lot of animals: a group of animals of the same species and same age bracket, raised in the same facility, at the same time and under uniform raising conditions.
5.7.Official sample: a sample collected by the competent authority that undergoes analysis for residues of veterinary drugs, contaminants and forbidden substances. Each sample must carry its corresponding sampling report, indicating the relevant aspects.
5.8.Residues of veterinary drugs: all the pharmacologically active substances, either excipient active principles or degradation products and their metabolites that remain in food products obtained from animals that were administered the veterinary drugs in question.
5.9.Veterinary drugs residues maximum limits (LMRMV): maximumconcentration of residues resulting from the use of veterinary drugs (expressed in mg/kg or in µg/kg on the basis of live animal weight) legally permitted and the use of which in the internal part or surface of a food is recognized as acceptable.
- ABBREVIATIONS
6.1.AC: Competent Authority
6.2.BPDV: Good Practices in the use of veterinary drugs
6.3.CITA: Center for the Research on Food Technology
6.4.DDT: Dicloro diphenil tricloroethane
6.5.FDA: Food and Drug Administration
6.6.ISO: International Standardization Organization
6.7.LANASEVE: National Laboratory of Veterinary Services
6.8.LMRMV: Veterinary Drugs Residues Maximum Limits (LMRDV)
6.9.MAG: Ministry of Agriculture and Livestock
6.10.SENASA: National Service on Animal Health
- PARTICIPANTS OF THE VETERINARY DRUGS AND CONTAMINANTS RESIDUES MONITORING PLAN
This group is coordinated by the Residues Program Coordinator, who reports directly to the SENASA’s Executive Office. The group includes the technical professional team of the corresponding areas:
⃰Department of Veterinary Drugs.
⃰Department of Innocuity of Animal Origin Products
⃰Department .of National Operations
⃰National Laboratory of Veterinary Services(LANASEVE) with two members, one for themicrobiology area and the other one for the toxicology area.
⃰Department of Quarantine.
⃰Ministry of Health
⃰The remaining members and collaborators are assigned at the discretion of the Program’s Manager.
- COMPETENT AUTHORITY
It is SENASA’s responsibility:
8.1.To implement the annual residues plan; which identifies the national measures to be applied during the year, as well as performing reviews and/or modifications to it, according to the animals’ annual productions and the risk circumstances.
8.2.To coordinate control and monitoring activities for the different residues.
8.3.To take corrective actions leading to ensure food safety and the meat cattle producers.
8.4.To collect the necessary data to assess the applied instruments and the results obtained in the execution of the foreseen measures in this program.
8.5.To transmit to the competent national and international entities, on an annual basis, the results generated during the period, according to official samplings.
- LABORATORIES
The laboratories responsible for the analytical procedures are assigned based on their technical competence and analytical capacity, according to the residues’ maximum limits in the monitored products.
For the 2013 Residues in Bovines Plan, the laboratories in charge are theLANASEVE (which belongs to SENASA-MAG) and other laboratories approved by FSIS-USDA (e.g. National Residues Laboratory of the Agro-livestock and Forestry Ministry of Nicaragua). Also was approved by SENASA the Laboratory LAMBDA which made analysis for heavy metals as lead, arsenic, Cloramphenicol and diethylstilbestrol.
The SENASA is formed by a Central Laboratory located in Barreal de Heredia, Campus Benjamín Núñez and three Regional Laboratories located in:
⃰San Carlos, Alajuela - Huetar Norteregion.
⃰Pérez Zeledón, San José – Bruncaregion.
⃰Liberia, Guanacaste – Chorotega region.
The laboratory implemented a Quality Management System in accordance with the INTE-ISO/IEC 17025:2005 Standard in May 07, 2007
In May 2007, the laboratory accredited its first two tests:
⃰Salmonella sppdetection in chicken rinse.
⃰Cadmium detection by Atomic Absorption Spectrophotometry (AAS) in muscle, liver, and kidney tissue, bovine muscle, pig muscle, fish and bovine species milk.
In April 2011, the LANASEVE accredited four more tests:
⃰Histamine determination by High Performance Liquid Chromatography(HPLC) in aquaculture.
⃰Salmonella spp detection on sponge in bovine and porcine.
⃰Clostridium perfringens in water.
⃰Staphylococcus aureuspositive coagulase in aquaculture.
- DRUGS RESIDUES AND CONTAMINANTS TO BE MONITORED
In the Costa Rican legislation, the control of veterinary drugs is framed within the SENASA lawn°8495 and it is carried out by the Department ofVeterinary Drugs, which is responsible for registering veterinary drugs and for verifying that they are being used following the “good veterinary practices guidelines”.
⃰In addition, theCoordinator sets up all the elaboration and the coordination activities of the Residues Plan for Bovines 2014and must report to SENASA’s head office To this effect, the Coordinator, who acts on behalf of the Executive Division, coordinates efforts with all the actors of the production chain of the animal origin products for human consumption as well as the other departments: “Department of veterinary medicines”, “”, “Department of National Operations”, National Laboratory of Veterinary Service, “Department of Innocuity of Animal Origin Products”Department of animal food”, as well as other programs and linked entities.
According to the Register Office of the DMV, there are registered 4.251medicaments. Twoof the most important groups are the antibiotics and parasiticides.In the graphics, some of the different groups of compoundsare shown as an example:
The Coordinator of the Residues Plan prepares annual plans in conformity with parameters, for instance, toxicity, use, pharmaco-kinetic, availability of the appropriate methodology and analytical capacity among others.
The Coordinator is also in charge of gathering the results from the veterinary medicine residues and contaminants obtained on a yearly basis, with the purpose of evaluating the efficiency of the measures taken or the corrective actions to prevent food products of animal origin from becoming a health hazard once they are integrated into the food chain.
Should the Residues Plan lack the national regulations or parameters to manage some significant residue evaluation of a veterinary drug or contaminant in the production, it has the power to adopt the norms of its international partners, for instance, the ones on the Codex Alimentarius, the FDA and the European Union.
- SAMPLING PROTOCOL
The procedure and the planning for the gathering of official samples are carried out by the SENASA staff in a way to ensure it is randomly made, as defined by the Residues National Plan. The samples are taken by an official representative of the CA, in the various registered establishments.
The control of veterinary drugs residues, contaminants and forbidden substances is be executed through the use of samples at the different stages of the production chain.
- METHODS OF ANALYSIS
In the analysis of residues, contaminants and forbidden substances, the laboratory uses official analytical methods or validated methods which performances have been tested to be in conformity with international norms.
- INTERPRETATION OF RESULTS
The results are interpreted in accordance with the results of the laboratories’ reports and the residues maximum limits variables.
Should an illegal treatment with unregistered substances or unauthorized by the DVM of SENASA be detected or in the case of suspicious illegal use of a drug, the CA has the authority to require samples and additional analysis to those establishedin the Residues Control Plan 2014.
- ACTIONS TO BE IMPLEMENTED
14.1.Detection of forbidden substances for use in bovines
After having carried out the analysis of the residues of the substances subject to control and if positive results are detected for banned substances, the SENASA implements necessary measures in order to ensure access to the information linked with:
14.1.1.All the needed elements for the proper identification of the animals, origin or shipping point.
14.1.2.The needed precision related to the analysis and its results. Besides, the following actions are carried out:
14.1.3.An investigation to determine the reasons causing the presence of the residues.
14.1.4.In case of an illegal treatment, an investigation on all the production chain on the source or sources of the detected substances including animal feed production.
14.1.5.All other additional investigations that the CA may deem necessary. The sampled animals must be clearly identified.
14.2.Presence of residues and/or contaminants in levels which exceed the residual maximum limits
When residues of authorized veterinary drugs are found at levels that exceed MRL, an investigation is carried out through the entire production chain on the source or sources of the detected substances. According to the results of such investigation, the CA has to require and verify the implementation of corrective actions to prevent the repetition of the infraction. The actions are approved by the CA on the basis of their efficiency and degree of application.
Other measures to guarantee public health are the control moves from a monitoring system to a surveillance system andother actions deemed by the CA as relevant.
- PENALTIES
According to the Costa Rican legislation, the State has the authority to penalize those who commit infractions according to SENASA’s law n°8495, Chapter IX “Infringements and sanctions”, Article 78, which makes references on sanctions in entries d, e, g, i, j and l, as well as articles 79, 80, 81 y 82.
- FINANCIAL ADMINISTRATIVE ASPECTS
SENASA will count with the required financial and human resources in order to implement this plan.
Ministerio de Agricultura y Ganadería • Servicio Nacional de Salud Animal
Tel.: (506) 2260-8300 • Fax (506)2262-0221
1
- APPENDIXES
- Appendix 1. Sampling results of residues in bovines duringthe year 2013.
Group of compounds / Compounds / Analyzed tissue / Analyzed samples / Negative samples / Positive samples / Method
used
Organochlorinates / Endrin / Fat / 135 / 135 / 0 / CG-ECD
Dieldrin / Fat / 135 / 135 / 0 / CG-ECD
aldrin / Fat / 135 / 135 / 0 / CG-ECD
Endosulfán / Fat / 135 / 135 / 0 / CG-ECD
Heptacloro / Fat / 135 / 135 / 0 / CG-ECD
heptacloroepoxido / Fat / 135 / 135 / 0 / CG-ECD
DDT and metabolites / Fat / 135 / 135 / 0 / CG-ECD
metoxicloro / Fat / 135 / 135 / 0 / CG-ECD
PCB s / Fat / 135 / 135 / 0 / CG-ECD
Organophosphates / Clorpiriphos / Liver / 135 / 135 / 0 / CG-NPD
Coumaphos / Liver / 135 / 135 / 0 / CG-NPD
Ronnel / Liver / 135 / 135 / 0 / CG-NPD
Etión / Liver / 135 / 135 / 0 / CG-NPD
Metil parathion / Liver / 135 / 135 / 0 / CG-NPD
malathión / Liver / 135 / 135 / 0 / CG-NPD
Diazinon / Liver / 135 / 135 / 0 / CG-NPD
Dichlorvos / Liver / 135 / 135 / 0 / CG-NPD
Benzimidazoles / Thiabendazole / Muscle / 135 / 135 / 0 / HPLC-UV
Fenbendazole / Muscle / 135 / 135 / 0 / HPLC-UV
Oxibendazole / Muscle / 135 / 135 / 0 / HPLC-UV
Mebendazole / Muscle / 135 / 135 / 0 / HPLC-UV
febantel / Muscle / 135 / 135 / 0 / HPLC-UV
Macrocyclic lactones / Ivermectin / Liver and muscle / 277 / 274 / 3 / HPLC-FL
Abamectin / Liver and muscle / 277 / 277 / 0 / HPLC-FL
Moxidectin / Liver and muscle / 277 / 277 / 0 / HPLC-FL
Doramectin / Liver and muscle / 277 / 277 / 0 / HPLC-FL
Group of compounds / Compounds / Analyzed tissue / Analyzed samples / Negative samples / Positive samples / Method
used
Heavy metals / Cadmium / Muscle / 130 / 130 / 0 / AAS
arsenic / Muscle / 70 / 70 / 0 / AAS
lead / Muscle / 79 / 79 / 0 / AAS
Diethylstilbestrol / Diethylstilbestrol / Liver / 73 / 73 / 0 / HPLC-MS-MS
Cloramphenicol / chloramphenicol / Muscle / 82 / 82 / 0 / HPLC-MS-MS
Animal species / Animal species / Muscle / 87 / 0 / 87 / Microdiffusion
Antibiotics / Erythromycin / Kidney / 131 / 131 / 0 / Micro testing USDA-FSIS
Neomycin / Kidney / 131 / 131 / 0 / Micro testing USDA-FSIS
Oxitetracycline / Kidney / 131 / 131 / 0 / Micro testing USDA-FSIS
Penicillin G / Kidney / 131 / 131 / 0 / Micro testing USDA-FSIS
tetracycline / Kidney / 131 / 131 / 0 / Micro testing USDA-FSIS
Sulfonamides / Sulfacetamide / Kidney / 134 / 134 / 0 / Micro testing USDA-FSIS
Sulfachloropyridazine / Kidney / 134 / 134 / 0 / Micro testing USDA-FSIS
Sulfamethoxazole / Kidney / 134 / 134 / 0 / Micro testing USDA-FSIS
Sulfadimethoxine / Kidney / 134 / 134 / 0 / Micro testing USDA-FSIS
Sulfaquinoxaline / Kidney / 134 / 134 / 0 / Micro testing USDA-FSIS
Sulfatiazol / Kidney / 134 / 134 / 0 / Micro testing USDA-FSIS
Ministerio de Agricultura y Ganadería • Servicio Nacional de Salud Animal