Residues Control Program in Livestock Products Year 2007

RESIDUES CONTROL PROGRAM IN LIVESTOCK PRODUCTS YEAR 2007

CHILE 2007 2

Index

1. INTRODUCTION………………………………………………………………………..…………3 2. PARTICIPANTENTITIES……………………………………………………………………….…4 2.1 Regulating Entity: Agriculture and Livestock Service, Ministry of Agriculture...... 4 2.2 Residues Determination Laboratories Authorized by the Agriculture and Livestock Service.…6 2.3 Reference Laboratories………………………………………………………………………….6 2.4 Slaughtering Plants and Processing Plants included in the Residues Control Plan………..……6 2.4.1 Ovine Slaughtering Plants...... 6 2.4.2 Swine Salughtering Plants...... 7 2.4.3 Bovine Slaughtering Plants...... 7 2.4.4 Poultry Slaughtering Plants ...... 7 2.4.5 Game Animals Processing Plants ...... 7 2.4.6 Honey Collecting Establishments...... 8 2.4.7 Dairy Processing Plants...... 8 2.5 Establishments supervised for Exportation………..……………………………………8 3. National Production...... 9 3.1 Meat Products……………………………………………………………………………………..9 3.2 Dairy Products…………………………………………………………………….10 4. OBJETIVES...... 10 5. WORK METHODOLOGY...... 11 5.1 In Force Legislation……………………………………………………………………………11 5.2 Type of Sampling…………………………………………………………………………….13 5.2.1 Sampling at fields level...... 13 5.3 Residues to be analyzed…………………………………………………………….……………13 5.3.1 Residues Control Plan in Ovine Meat...... 13 5.3.2 Residues Control Plan in Swine ...... 15 5.3.3 Residues Control Plan in Bovines ...... 18 5.3.4 Residues Control Plan in Poultry...... 20 5.3.5 Residues Control Plan in Game Animals ...... 25 5.3.6 Residues Control Plan in Honey...... 25 5.3.7 Residues Control Plan in Dairy Products ...... 26 5.4 Measures to be adopted in case of detection of a sample with prohibited substances or higher Action Limits Levels (MRL)………………………………………………………………………….28 5.4.1 CASE N° 1 : Negative confirmatory Analysis ...... 28 5.4.2 CASE N°2 Positive confirmatory Analysis to prohibited substances...... …29 5.4.3 CASE N°3. Confirmatory Analysis on Action Limits (MRL)...... 29 5.4.4 Regularization of the situation...... 30 6. Annexes ...... 31 6.1 Annex 1: Sample Collection Form……………………………………………………….……31 6.2 Annex 2: Results Form ………………………………………………………………….………32 6.3 Annex 3: Predial Investigation Form ……………………………………………………. 33 6.4 Annex 4:Registration Process of VMP´s ………..……………………………………….35 6.5 Annex 5: Diagram Program of Residues Control ………………………….……………..36

RESIDUES CONTROL PROGRAM IN LIVESTOCK PRODUCTS

1. INTRODUCTION

Mission of the Agriculture and Livestock Service is to contribute to the agriculture and livestock development of the country, by protecting the vegetal sanity, animal health, protection and preservation of renewable natural resources that impact on farming production of the country and in the control of farming products and commodities subject to legal regulations and standards. Among its duties, the main one is to watch over the sanity of livestock production, to be responsible for the official registration, inspection and sanitary control of pharmaceutical products of veterinary use, to try to eliminate sanitary restrains imposed by countries or foreign markets for the commercialization of Chilean forest and farming products and to be guarantors of zoo sanitary, dietetics and of the quality and safeness of livestock products.

International commerce of livestock origin products, is each time more demanding. Currently, to the sanitary type restrictions, it should be added those related to the use of chemical supplies in the production, whether these are hormones, pesticides, antibiotics or heavy metals, among others.

Considering the excellent national zoo sanitary situation, Chile, can potentially compete with animal origin products in the world markets, pointing out that our productive system use veterinary medicinal products, pesticides and agro- chemicals in general, in a wise and efficient way, taking care of the environment and of the population’s health; being this the only way to maintain those market already reached and accede to new markets for our livestock commodities.

In order to comply with exportation requirements and, also, to have an schematic information of annual character on the presence of residues in animal populations destined to be exported, it has been defined and designed the operation of the Residues Control Program (RCP) in Livestock Products. Each plan permits the assessment of residues trends and to identify sectors of the livestock industry where residue problems are detected and when necessary, to carry out corrective measures.

This Program started in 1987 in ovine meats; in 1998 it was implemented in poultry, swine, and hare meats, and in honey; during the year 2000 it was established in turkey meats. By the middle of 2002, bovine meats were included in the program and during 2005, it included dairy products.

This system complements other Programs carried out in the food safety area of the Service; as in Animal Establishments under Official Certification (PABCO) and of Quality Assurance System.

2. PARTICIPANT ENTITIES

2.1 REGULATING ENTITY: AGRICULTURE AND LIVESTOCK SERVICE, MINISTRY OF AGRICULTURE

It is organized in 5 Technical Divisions: Agriculture Protection, Seeds, Natural Resources, Laboratories and Quarantine Stations and the Livestock Protection Division. This last one is in charge of the coordination of 2007 RCP, specifically its Industry and Technology Subdepartment. Figure 1 shows the organization flow sheet of the Agriculture and Livestock Service and Figure 2 shows the organization flow sheet of Livestock Protection Division.

Figure 1: Agriculture and Livestock Organization Flow Sheet

Figure 2: Livestock Protection Division Organization Flow Sheet

The Service responsibility at central level is to draw up an annual residues control program of exportation livestock products in coordination with other Subdepartments. • To program sample collection in the different establishments incorporated in the plan. • To coordinate, at national level, the plan execution and to supervise the program execution for the annual sample collection, their dispatch to national and reference laboratories. • To systematize in a data base the information on sample collection and the results of the program. • To carry out a follow-up and inform fulfilment level of committed goals with respect to this project. • To draw up all necessary documentation related to Residues Control Program guidelines, manuals, etc. • To send information requested by different countries in relation to this issue.

2.2 RESIDUES DETERMINATION LABORATORIES AUTHORISED BY THE AGRICULTURE AND LIVESTOCK SERVICE

At present there is a network of 4 Laboratories for Residues determination accredited by the Service, all of them located in the Metropolitan Region.

Supervision of this network is performed through the Third Parties Accreditation System that was established by the Service during the year 2004, which settles a general standard that has to be complied by all accredited entities and in the case of assay laboratories, there is a specific regulation. This establishes necessary requirements to carry out the analysis/assays as support to the execution of different activities within the frame of officials programs of the Service and, for each analysis area it should also comply with the corresponding technical guideline. All accredited third party shall be supervised by SAG, by means of periodical and programmed follow-up actions, without prejudice of the supervising faculties of the Service.

Accreditation ISO 17025 granted in Chile by the National Normalization Institute (NNI), is one of the requirements demanded by the technical guideline of residues diagnostic. This Accreditation System was enforced on 02/06/2005, date when it was approved by Exempt Resolution Nº 2488/2005 of the National SAG Director.

2.3 REFERENCE LABORATORY

Reference Laboratory related to heavy metals issues is formed by the laboratory of the Nuclear Energy Chilean Commission (NECHC). In the case of confirmatory analyses for any other substance, the Service requests the services of DILAVE Laboratory, Miguel Rubio, Uruguay. Since the year 2005, the LGC Laboratory from England was incorporated as a Reference Laboratory.

2.4 SLAUGHTERING PLANTS AND PROCESSING PLANTS INCLUDED IN THE RESIDUES CONTROL PLAN

2.4.1 Ovine Slaughtering Plants

Ovine abattoirs included in this program are located in the VIII Region, Province of Chillán, the XI Region, Province of Coyhaique and the XII Region, Province of Magallanes and in the Province of Última Esperanza.

Exportation volume of these slaughtering plants during 2005-2006 was 554.140 animals. Calculation of number of samples for each plant was made based on the slaughtering for exportation purposes of each one of them, as established in the Directive 96/23/CE. 7

2.4.2 Swine Slaughtering Plants

In the Residues Control Plan of swine meats, 6 slaughtering plants are participating: 2 in the Metropolitan Region, 3 in the VI Region and 1 in the VII Region. Number of samples calculated for each abattoir is defined in relation to the slaughtering volume of each one of them and of the number of establishments from which they receive animals to be slaughtered.

Slaughtering volume for exportation during 2006 was 2.411.120 pigs (196.752,1 tons).

2.4.3 Bovine Slaughtering Plants

Abattoirs included in the Residues Control Plant of Bovine meats, is nation wide, and it considers abattoirs from the I to the XII Region, including the Metropolitan Region. Number of samples calculated for each abattoir is defined in relation to the slaughtering volume of each one of them. National slaughtering volume for 2006 was 934.264 animals.

2.4.4 Poultry Slaughtering Plants

Abattoirs included in the Residues Control Plant of broiler meats are 5. One of them is located in the I Region, 3 in the Metropolitan Region and 1 in the VI Region of the country. Number of samples per abattoirs is calculated based on the volume of slaughtering registered at each abattoir. Slaughtering volume for exportation in 2006 was 85.167,9 tons of chicken (dead weight).

In the case of turkey meat production, this is concentrated in 2 slaughtering plants; one is located in the V Region of the country and the second in the Metropolitan Region. Samples distribution per abattoir is made based on the volume of slaughtering registered at each abattoir. Slaughtering volume for exportation in 2006 was 27.509 tons of turkey (dead weight).

2.4.5 Game Animals Processing Plants

Currently there are two game animals processing plants, specifically hares, located one in the XI Region and the other in the XII Region of the country. Number of samples per Plant is defined based on the exported volume at each one of them.

Slaughtering volume for exportation for the year 2006 was of 105.496 units of hares.

During the year 2006, capturing of 2.000 guanacos was authorized, which were processed in the plant located in the XII Region.

2.4.6 Honey Collector Companies

Honey collector companies of the country that export their product, are mainly concentrated in the Metropolitan Region, the V, VI, VIII and X Region of the country. During 2006, exported volume was 7.483 tons.

2.4.7 Dairy Products Elaborating Plants

Dairy products elaborating plants are located in the X, IX, V Region of the country and in the Metropolitan Region.

Number of samples per Plant was defined based on the volume of milk received by each one of them. The total amount of milk received in dairy plants of the country during 2006 was 1.818.115.200 litters of raw milk. 69,9% of milk was received in the X Region, 13,5% in the IX Region, 8,6% in the VIII and remaining 7,9% in the Metropolitan Region. Plants incorporated in the Residues Control Plan represent more than 70% of total national production.

2.5 ESTABLISHMENTS SUPERVISED FOR EXPORTATION

The Agriculture and Livestock Service has implemented the System of Establishments Under Official Control, mainly directed to those establishments that destine part of their production to exportation. In the year 2007, swine, poultry (broiler, turkeys) and bovines PABCO fields will be sampled. 9

3. NATIONAL PRODUCTION

3.1 MEAT PRODUCTS

Following table shows national slaughtering of animals during 2006.

National slaughtering of animals per specie and type head number

SPECIES 2006 BOVINES 934.264 Heifers 493.949 Cows 219.800 Oxen 20.462 Bulls and Oxen 22.332 Young Cows 162.591 Calves 15.130 OVINES 770.673 SWINE 4.717.558 CAPRINES 3.455 EQUINES 50.248 POULTRY (Thousands) 232.738 Broilers 221.099 Turkeys 8.730 Others 2.908 Source: Drawn up by ODEPA with INE antecedents.

National slaughtering of animals per specie and type tons of bulk meat

SPECIES 2006 BOVINES 215.583,6 Heifers 121.498,8 Cows 47.192,4 Oxen 8.008,9 Bulls and Oxen 6.347,2 Young cows 30.668,4 Calves 1.867,8 OVINES 11.250 SWINE 464.805 CAPRINES 39 EQUINES 9.440 POULTRY 607.548 Broilers 512.904 Turkeys 94.644 Source: Drawn up by ODEPA with INE antecedents.

3.2 DAIRY PRODUCTS

Milk production, milk reception and elaboration of dairy products during 2005

Product Units 2006 MILK RECEPTION LTS 1.818.115.205 FLUID MILK 319.494 PROCESSING LTS ELABORATION OF 69.490 POWDERED MILK KGS CREAM CHEESE KGS 9.088 CHEESE KGS 62.071 YOGHURT LTS 189.436 CULTURED OR 14.216 FERMENTED MILK LTS CREAM KGS 20.379 BUTTER KGS 17.157 POWDERED SERUM KGS 23.217 CONDENSED MILK KGS 43.426 BLANCMANGE KGS 24.846 MODIFIED MILK KGS 930 EVAPORATED MILK KGS 30

4. OBJECTIVES

The objectives of the Residues Control Program are:

1. To control veterinary medicinal products and pesticides of farm use being used according to applicable regulations.

2. To verify that in the case of prohibited products, these are really not being used.

3. To make sure that animal origin products destined for human consumption do not contain chemical substances over permitted limits.

4. To implement corrective actions at field’s level, in case of detection of chemical substances over permitted level.

5. WORK METHODOLOGY

5.1 LEGAL FRAME

In force current Legislation in this country considers faculties of the Agriculture and Livestock Service, Registry and Control of Veterinary Medicinal Products, Resolutions of the Health Ministry setting out maximum residues limits of veterinary medicinal products in food destined for human consumption and maximum residues tolerances of pest control substances (insecticides) in food for Human Consumption and Resolutions established by the Agriculture and Livestock Service such as:

Ministry of Agriculture, Agriculture and Livestock Service

• Law Nº 18.755, January 7, 1989, organic of the Agriculture and Livestock Service and its amendments introduced by Law Nº 19.283 as of January 5, 1994 that in its Article 3, letter m, indicates that the SAG has to apply and supervise fulfilment of legal regulations and standards on production and commercialization of seeds, pesticides, fertilizers, animal feed, ethylic alcohols, alcoholic beverages and vinegars; fairs and animals’ shows and cattle classification and typifying of their carcasses, nomenclature of their cuts and other issues settled by law, as well as to carry out bacteriological and dietetic analyses and others that were pertinent and to certify fitness for human consumption of primary farming products destined to be exported.

• SAG Resolution Nº 3673 as of 24/12/1998: It creates residues control project in exportation livestock products.

• Exempt SAG Resolution Nº 1.521 as of 25/05/1999: It settles references of Maximum Residues Limits of veterinary medicinal products, to define safeguard period of pharmaceutical products of exclusive veterinary use.

• Exempt SAG Resolution Nº 3.599 of 29/11/1996: It forbids the use of veterinary medicinal products containing chloramphenicol or of any of its salts, in animals which products and by-products are destined for human consumption.

• Exempt SAG Resolution Nº 1.500 as of 14/05/1998: It forbids the use of pharmaceutical products of veterinary use containing substances derived from nitrofurans and 5-nitroimidazoles, to be administered to animals which products are or may be destined to human feeding at any stage of their life.

• Exempt SAG Resolution Nº 3.136 as of 21/10/1999: It establishes general Biosafety standards for biotechnological pharmaceutical products containing genetically modified organisms.

• Exempt SAG Resolution Nº 206 as of 23/01/2004: It settles sales conditions under balance VMP’s Retained Veterinary Prescription for pharmaceutical products of exclusive veterinary use, with anabolic and thyroestatic effects.

• Supreme Decree Nº 25 as of 2005: New Regulation on Pharmaceutical Products for Exclusive Veterinary Use, published in the Official Newspaper on October 8, 2005. It derogates Supreme Decree Nº 139 as of 1995.

• Exempt SAG Resolution Nº 557 as of 1980, establishing the list and guarantee of feeding components to be used in the elaboration of animal food and food supplements.

• Exempt SAG Resolution Nº 1.992 as of May 5, 2006, indicating list of authorized additives.

• Exempt SAG Resolution Nº 2.231 as of 22/07/1998: It creates Animal Species Establishments under official sanitary control.

• Exempt SAG Resolution Nº 3.772 as of 21/07/2005. It creates animal’s Establishments under official certification, PABCO, and derogates Resolution Nº 2.231 as of 22/07/1998.

• SAG Resolution Nº 207, dated January 23, 2004 that creates the “National Directory of Authorized Animal Establishments to export to the European Union”, for bovine, ovine and swine species, and sets the creation of a Procedures Manual, that defines the requirements to be complied by the Establishments to enter to the “PABCO EU Directory”, amended by Resolution N° 2080 dated May 06, 2005, that incorporates poultry species in the National Directory of Authorized Animal Establishments to export to the European Union.

• Exempt SAG Resolution Nº 3321, dated September 13, 2004, creating an “Official Bovine Sanitary Traceability Program”.

Ministry of Health

• Supreme Decree Nº 977, Regulation dated 13/05/1997 that approves Food Sanitary Regulation, establishing sanitary conditions to be followed by production, elaboration for importation, packing, storage distribution and food sale for human consumption, with the objective of protecting health and nutrition of the population and to guarantee provision of healthy and safe products.

• Exempt MINSAL Resolution Nº 1462 dated 25/08/1999 that sets the maximum residue limits of veterinary medicinal products in foods destined for human consumption.

• Exempt MINSAL Resolution Nº 581; dated 06/03/1999 that sets maximum residues tolerances of pesticides in foods for domestic consumption.

5.2 TYPE OF SAMPLING

In order to have the widest possible information about residues, it has been instructed to SAG professionals in charge of sample collections, to include in the annual sampling the highest possible amount of fields of field universe that send animals to the slaughtering houses where sampling process is carried out. The above is with the purpose of having information of each one of the fields that are included in the system.

Samples are randomly collected under the responsibility of the official veterinary inspector of the Service in each establishment and by slaughtering lots. If on sampling day, a field with antecedents of having violated the MRL presents for slaughtering, this should be sampled as a way to have a control on said breeder. Likewise, if during sampling process it is detected an animal suspicious of having received prohibited substances or veterinary medicinal products, this should also be sampled.

Programming is made by the Service and it is only known by officers of this service.

5.2.1 Sampling at Field Level

This activity is carried out within the frame of Herds or Establishments of Animal Species under Official Certification (PABCO).

Apart from scheduled samples to be collected in slaughterhouses, monitoring is carried out in Establishments that export and belong to PABCO.

5.3 RESIDUES TO BE ANALYZED

Residues Plan 2007 includes residues groups defined by Communitarian Directive 96/23 as of April 1996, including determination of meats and in live animals, honey and/or dairy products. These are defined according to Decision 97/747 as of October 1997.

5.3.1 Residues Control Plan on Ovine Meats

Residues control plan on ovine meats to be exported has been carried out since season 1987-1988 and it has permitted the certification of exportations to the European Union, among other destinies. Following table details substances, matrices, methods, detection limits, action limits and number of samples to be collected. 14

5.3.1.1 Residues of Group A substances in ovine meats

L. Detection L. of Action N° Residue Category Residues Matrix Method (ppb) (ppb) Samples

Dietilestylbestrol

A1 Liver GC-MS 1 1 10 Stilbenes Hexestrol Dienestrol Thiouracil A2 HPLC-UV 500 500 Anti-thyroids Agents Muscle Tapazole 10

A3 Trembolone Acetate Liver ELISA/GC-MS 2 2 Steroids 10 17-B-Stradiol A4 Resorcilinic Acid By- Zeranol Liver ELISA/GC-MS 2 2 10 products Clembuterol A 5 Cimaterol, Terbutaline, Liver LC-MS-MS 1 1 B-Adrenergics Zilpaterol, Ractopamine, 10 Mapenterol

A6 Chloramphenicol Muscle LC- MS-MS 0,3 0,3 6 Substances included in Annex IV Nitrofurans (1) Muscle LC- MS-MS 0,5 1 6

(1) It corresponds to AMOZ, AOZ, SEM and AHD metabolites analyses

B.- Residues of Group B substances in ovine meats

L. L. N° Residue category Residues Matrix Method Detection Action samples (ppb) (ppb) Antibiotics Muscle 4 Plates (1) (2) 37 B1 Antibacterian Substances Sulphas Muscle HPLC-Fluorine (3) 100 31 Quinolones(*) Muscle HPLC-Fluorine 2 100 22

Ivermectin Liver HPLC-Fluorine 7,5 100 10 B2 –a Antihelmintics Bencimidazoles Liver HPLC-DAD 200 (4) 18

B2-b Carbadox Muscle HPLC-DAD 5 5 20 Anticoccidials Cypermetrine, αCypermetrine, 200 Fenvalerato, B2-c Esfenvalerato Fat GC-ECD 10 10 Piretroids y Carbamates Permetrine, Cyalotrine 500 Cyflutrine, Deltametrine 50 Carbamates Muscle HPLC-UV 50 (5) 12

B2-d Chlorpromacine Kidney HPLC-DAD 50 50 22 Tranquilizers B2-e Non Steroidal Phenilbutazone Muscle HPLC-DAD 18 36 18 Antiinflammatories B3-a Organochlorinated Organochlorinated Fat GC-ECD (6) (7) 9 components B3-B Organophosphorated Fat GC-TSD (8) 200 9 Organophosphorated 15

components

Lead AAS-gsf 10 100 B3-c Cadmium Muscle AAS-gsf 10 50 11 Chemical elements Mercury AAS/hg 10 1000 Arsenic AAS/hg 50 1000 B1 B3-d B2 Aflatest/ Aflatoxines Liver 0,3 5 10 Mycotoxins G1 HPLC- Fluorine G2 (1) Amoxicyllin (HPLC): 25 ppb ; Tetracycline (HPLC): 50 ppb; Erytromicine (HPLC): 100 ppb

(2) Amoxicyllin: 50 ppb; Tetracycline: 100 ppb; Erytromicine: 200 ppb

(3) Sulfatiazole, Sulfadiazine, Sulfamerazine, Sulfametazine, Sulfadimetoxine, Sulfaquinoxaline: 10 ppb.

(4) Febendazole: 500 ppb, Albendazole: 1000 ppb, Mebendazole :400 ppb, Oxibendazole: 200 ppb

(5) Aldicarb sulfoxide, Aldicarb sulfone, Oxamile, Metomile, Methiocarb sulfoxide, 3 Hidroxi carbofuran, Aldicarb, Carbofuran, 3 Ceto carbofuran: 50 ppb; Propoxur, Carbarilo, 1 Naphtol, Methiocarb, Cbz carb - 2 ( ctt ): 200 ppb

(6) Alfa BHC, Heptacloro, Heptaclorohepoxide, pp'DDE: (10 ppb); Gama BHC, Aldrin, Beta BHC, Gamaclordano, Dieldrin, op'DDD, Endrin, op'DDT, pp'DDD: (20 ppb); HCB, op'DDE, Alfaclordane, pp'DDT, Metoxiclor: (30 ppb).

(7) Aldrin, Dieldrin: 200 ppb; Alfa BHC, pp'DDE, op'DDD, pp'DDT, op'DDT, pp'DDD, op'DDE: 1000 ppb; Heptacloro, Heptaclorohepoxide: 200 ppb; Gama BHC, Beta BHC, Gamaclordane, Alfaclordane, Endrin: 50 ppb; HCB: 30 ppb; Metoxiclor: 30 ppb.

(8) Diazinon, Clorpiriphos metil, Clorpiriphos etil, Fenthion, Bromophos etil, Bromophos metil, Ethion, Parathion etil: 20 ppb; Fenclorphos, Fenitrothion, Dimetoato: 30 ppb.

(*) Ciprofloxacine and Enrofloxacine: 2 ppb 5.3.2 Residue Control Plan in Swine

RCP 2007 Plan includes residues group A, with determinations on meats and on live animals and of group B. Following table details the substances, matrixes, methods, detection limits, action limits and number of samples to be collected for swine.

5.3.2.1 Residues of group A substances in swine meat

L. Detection L. of action N° Residue Category Residues Matrix Methods (ppb) (ppb) Samples

Dietilestylbestrol

A1 Liver GC-MS 1 1 151 Stilbenes Hexestrol Dienestrol Thiouracil

HPLC-UV 500 500 75 Muscle Tapazole A2 Ethyltiouracil** Antithyroids Agents Dimetyltiouracil** Phenyltiouracil** Urine LC- MS-MS 50 50 75 Propiltiouracil** Tiouracil** Tapazole** A3 Trembolone Acetato Steroids Liver ELISA/GC-MS 2 2 75 17-B-Stradiol 16

Nandrolone** Boldenone** Liver GC-MS 2 2 75 Metyltestosterone** Progesterone** A4 Resorcilinic Acid By- Zeranol (1) Liver ELISA/GC-MS 2 2 160 product Clembuterol Cimaterol, A 5 Terbutaline, Liver LC- MS-MS 1 1 B-Adrenergics Zilpaterol, 151 Ractopamine, Mapenterol

Chloramphenicol Muscle LC- MS-MS 0,3 0,3 67 A6 Substances included Nitrofurans (2) Muscle LC- MS-MS 0,5 1 57 in Annex IV

Nitroimidazoles (3) Muscle LC- MS-MS 1 1 57

(1) During the second semester Taleranol (2 ppb) analysis will be included (2) It corresponds to AMOZ, AOZ, SEM and AHD metabolites analyses (3) It corresponds to Dimitronidazole, Metronidazole and Ronidazole ** Will be implement during the second semester of 2007.

5.3.2.2 Residues of Group A substances in live swine

Samples in Residue Category Residues Matrix Method L. Detection Farms

Dietilestylbestrol

A1 3 ppb Hexestrol Serum GC-MS Stilbenes Dienestrol Acetate of Trembolone- 17- B-Stradiol A3 Nandrolone** 25 Serum ELISA/GC-MS 2 ppb Steroids Boldenone** Methyl- testosterone** Progesterone** A4 Resorcilinic Acid By- Zeranol (1) Serum ELISA/GC-MS 2 ppb products A 5 Clembuterol Hair ELISA/GC-MS 5 ppb 25 B-Adrenergics (1) During the second semester Taleranol (2 ppb) analysis will be included ** Will be implement during the second semester of 2007.

5.3.2.3 Residue Group B substances in swine meat

L. L. Detection N° Residue Category Residues Matrix Method Action (ppb) samples (ppb) Antibiotics Muscle 4 Plates (1) (2) 137

Sulphas Muscle HPLC-Fluorine (3) 100 142 B1 Antibacterian Quinolones (*) Muscle HPLC-Fluorine 2 100 139 Substances Lyncomicin Muscle HPLC-DAD 50 100 149

Tylosin** Muscle HPLC-DAD 50 100 142 Ivermectin Liver HPLC-Fluorine 7,5 100 35 B2 –a Abamectin** Liver HPLC-Fluorine 10 20 28 Antihelmintics Bencimidazoles Liver HPLC-DAD 200 (4) 50

Salinomicine Muscle HPLC-DAD 45 50 35 B2-b Anti-coccidials Nicarbacine Muscle HPLC-DAD 100 200 50 Cypermetrine, αCypermetrine, 200 Fenvalerato, B2-c Esfenvalerato Fat GC-ECD 10 50 Piretroids and Permetrine, Cyalotrine 500 Carbamates Cyflutrine, Deltametrine 50 Carbamates Muscle HPLC-Fluorine 50 (5) 50

Chlorpromacine Kidney HPLC-DAD 50 50 35 B2-d Tranquilizers Azaperone** Kidney HPLC-DAD 50 100 25

B2-e Non Steroidal Fenilbutazone Muscle HPLC-DAD 18 36 35 Antiinflammatories Flunixin** Muscle HPLC-DAD 25 50 25

B2-f Carbadox Muscle HPLC-DAD 5 5 36 Other active Substances Olaquindox** Muscle HPLC-DAD 2 ** 50 B3-a Organochlorinated Organochlorinated Fat GC-ECD (6) (7) 54 Compounds B3-B Organophosphorated Organophosphorated Fat GC-TSD (8) 200 58 Compounds Lead AAS-gsf 10 100 B3-c Cadmium AAS-gsf 10 50 Muscle 68 Chemical Elements Mercury AAS/hg 10 1000 Arsenic AAS/hg 50 1000 B1 B3-d B2 Aflatest/ Aflatoxines Liver 0,3 5 20 Mycotoxins G1 HPLC- Fluorine G2 (1) Amoxicyllin (HPLC): 25 ppb ; Tetracycline (HPLC): 50 ppb; Erytromicine (HPLC): 100 ppb

(2) Amoxicyllin: 50 ppb; Tetracycline: 100 ppb; Erytromicine: 200 ppb

(3) Sulfatiazole, Sulfadiazine, Sulfamerazine, Sulfametazine, Sulfadimetoxine, Sulfaquinoxaline: 10 ppb.

(4) Febendazole: 500 ppb, Albendazole: 1000 ppb, Mebendazole :400 ppb, Oxibendazole: 200 ppb

(8) Diazinon, Clorpiriphos metil, Clorpiriphos etil, Fenthion, Bromophos etil, Bromophos metil, Ethion, Parathion etil: 20 ppb; Fenclorphos, Fenitrothion, Dimetoato: 30 ppb.

(*) Ciprofloxacine and Enrofloxacine: 2 ppb ** Will be implement during the second semester, 2007

5.3.3 Residues Control Plan in Bovines

In 2007 Plan, meat samples as well as live animal samples will be analyzed. Following tables detail substances, matrixes, methods, detection limits, action limits and number of samples to be collected.

5.3.3.1 Residues of Group A substances in bovine meat

L. Detection L. of Action N° Residue Category Residues Matrix Method (ppb) (ppb) Samples

Dietilestylbestrol

A1 Liver GC-MS 1 1 321 Stilbenes Hexestrol Dienestrol Thiouracil

HPLC-UV 500 500 155 Muscle Tapazole A2 Ethylthiouracil** Antithyroid Agents Dimetylthiouracil** Phenylthiouracil** Urine LC- MS-MS 50 50 166 Propilthiouracil** Thiouracil** Tapazole** Trembolone Acetate Liver ELISA/GC-MS 2 2 155 17-B-Stradiol A3 Steroids Nandrolone** Boldenone** Liver GC-MS 2 2 168 Methiltestosterone** Progesterone** A4 Resorcilinic Acid Zeranol (1) Liver ELISA/GC-MS 2 2 273 Sub-products Clembuterol Liver ELISA/GC-MS 1 1 155 A 5 B-Adrenergics Cimaterol, Terbutaline, Zilpaterol, Ractopamine, Liver LC- MS-MS 1 1 170 Mapenterol

A6 Chloranphenicol Muscle LC- MS-MS 0,3 0,3 163 Substances included in Annex IV Nitrofurans (2) Muscle LC- MS-MS 0,5 1 163

(1) During the second semester Taleranol (2 ppb) analysis will be included (2) It corresponds to AMOZ, AOZ, SEM AHD metabolites analyses ** Will be implement during the second semester, 2007 19

5.3.3.2 Residues of Group A substances in live Bovines

Residue Category Residues Matrix Method L. Detection Farm Samples Dietilestylbestrol

A1 Hexestrol Urine 1 ppb 50 GC-MS Stilbenes Dienestrol Ethylthiouracil** Dimetylthiouracil** A2 Phenylthiouracil** Urine LC-MS-MS 50 ppb 50 Anti-Thyroids Propilthiouracil** Thiouracil** Tapazole** Trembolone Acetate Nandrolone** A3 Boldenone** Urine ELISA/GC-MS 2 ppb 50 Steroids Methyltestosterone** Progesterone** A4 Resorcilinic Acid By Zeranol (1) Urine ELISA/GC-MS 2 ppb 50 Products

A 5 Clembuterol Hair ELISA/GC-MS 5 ppb 200 B-Adrenergics

(1) During the second semester Taleranol (2 ppb) analysis will be included ** To be implemented during the second semester, 2007

5.3.3.3 Residues of Group B substances in bovine meats

L. L. Detection N° Residue Category Residues Matrix Method Action (ppb) samples (ppb) Antibiotics Muscle 4 Plates (1) (2) 285

Sulphas Muscle HPLC-Fluorine (3) 100 112 B1 Antibacterian Quinolones (*) Muscle HPLC-Fluorine 2 100 112 Substances Florfenicol** Muscle HPLC-DAD 100 200 86

Flumequine** Muscle HPLC-Fluorine 100 200 112 Ivermectin Liver HPLC-Fluorine 7,5 100 58

Abamectin** Liver HPLC-Fluorine 10 20 58 B2 –a Antihelmintics Bencimidazoles Liver HPLC-DAD 200 (4) 58

Levamizol** Liver HPLC 50 100 44 B2-b Salinomicine Muscle HPLC-DAD 45 50 49 Anti-coccidials Cypermetrine, α-Cypermetrine, 200 Fenvalerato, B2-c Esfenvalerato Fat GC-ECD 10 49 Piretroids and Permetrine, Cyalotrine 500 Carbamates Cyflutrine, Deltametrine 50 Carbamates Muscle HPLC-Fluorine 50 (5) 49

Chlorpromacine Kidney HPLC-DAD 50 50 49 B2-d Tranquilizers Xylazine** Kidney HPLC-DAD 50 50 49 20

B2-e Non Steroidal Fenilbutazone Muscle HPLC-DAD 18 36 56 Antiinflammatories Flunixin** Muscle HPLC 25 50 49 B3-a Organochlorinated Organochlorinated Fat GC-ECD (6) (7) 38 Compounds B3-B Organophosphorated Organophosphorated Fat GC-TSD (8) 200 38 Compounds Lead AAS-gsf 10 100 B3-c Cadmium AAS-gsf 10 50 Muscle 39 Chemical Elements Mercury AAS/hg 10 1000 Arsenic AAS/hg 50 1000 B1 B3-d B2 Aflatest/ Aflatoxines Liver 0,3 5 25 Mycotoxins G1 HPLC- Fluorine G2 (1) Amoxicyllin (HPLC): 25 ppb ; Tetracycline (HPLC): 50 ppb; Erytromicine (HPLC): 100 ppb

(2) Amoxicyllin: 50 ppb; Tetracycline: 100 ppb; Erytromicine: 200 ppb

(3) Sulfatiazole, Sulfadiazine, Sulfamerazine, Sulfametazine, Sulfadimetoxine, Sulfaquinoxaline: 10 ppb.

(4) Febendazole: 500 ppb, Albendazole: 1000 ppb, Mebendazole :400 ppb, Oxibendazole: 200 ppb

(8) Diazinon, Clorpiriphos metil, Clorpiriphos etil, Fenthion, Bromophos etil, Bromophos metil, Ethion, Parathion etil: 20 ppb; Fenclorphos, Fenitrothion, Dimetoato: 30 ppb.

(*) Ciprofloxacine and Enrofloxacine: 2 ppb ** Will be implement during the second semester, 2007

5.3.4 Residues Control Plan in Poultry

In 2007 Plan, meat samples as well as live animal samples will be analyzed. Following tables detail substances, matrices, methods, detection limits, action limits and number of samples to be collected for broilers, turkeys and geese.

5.3.4.1 Residues of group A substances in broiler meats

L. Detection L. of action N° Residue Category Residues Matrix Methods (ppb) (ppb) Samples

Dietilestylbestrol

A1 Liver GC-MS 1 1 216 Stilbenes Hexestrol Dienestrol A3 Trembolone Acetate Steroids Liver ELISA/GC-MS 2 2 108 17-B-Stradiol 21

Nandrolone** Boldenone** Liver GC-MS 2 2 108 Methyltestosterone** Progesterone**

A4 Zeranol (1) Resorcilinic Acid By- Liver ELISA/GC-MS 2 2 216 product Clembuterol Cimaterol, A 5 Terbutalina, Liver LC- MS-MS 1 1 B-Adrenergics Zilpaterol, 180 Ractopamine, Mapenterol Chloramphenicol Muscle LC- MS-MS 0,3 0,3 77 A6 Substances included Nitrofurans (2) Muscle LC- MS-MS 0,5 1 91 in Annex IV Nitroimidazoles (3) Muscle LC- MS-MS 1 1 91

5.3.4.2 Residues of Group A substances in live broilers

Samples in Residue Category Residues Matrxz Method L. Detection Farms

Dietilestylbestrol

A1 3 ppb Hexestrol Serum GC-MS Stilbenes Dienestrol Trembolone Acetate- 17-B-Stradiol A3 Nandrolone** 100 Serum ELISA/GC-MS 2 ppb Steroids Boldenone** Methyl- testosterone** Progesterone** A4 Resorcilinic Acid By- Zeranol (1) Serum ELISA/GC-MS 2 ppb products A 5 Clembuterol Feathers ELISA/GC-MS 5 ppb 100 B-Adrenergics (1) During the second semester Taleranol (2 ppb) analysis will be included ** Will be implement during the second semester of 2007.

5.3.4.3 Residues of group B substances in broiler meats L. L. Detection N° Residue Category Residues Matrix Method Action (ppb) samples (ppb) Antibiotics Muscle 4 Plates (1) (2) 129

Sulphas Muscle HPLC-Fluorine (3) 100 115 B1 Antibacterian Quinolones (*) Muscle HPLC-Fluorine 2 100 141 Substances Lincomicyn Muscle HPLC-DAD 50 100 121

Bacitracin** Liver HPLC 10 *** 135 B2 –a Ivermectin Liver HPLC-Fluorine 7,5 15 58 Antihelmintics Levamizol** Liver HPLC 50 100 45 22

Bencimidazoles Liver HPLC-DAD 200 (4) 38

Salinomicine Muscle HPLC-DAD 45 50 45

Amprolio Muscle HPLC-DAD 100 200 26 B2-b Anticoccidials Nicarbacine Muscle HPLC-DAD 100 200 26 Clopidol Muscle HPLC-DAD 2500 5000 20

Tortrazuril** Muscle HPLC-DAD 50 100 45 Cypermetrine, α-Cypermetrine, 200 Fenvalerato, B2-c Esfenvalerato Fat GC-ECD 10 71 Piretroids and Permetrine, Cyalotrine 500 Carbamates Cyflutrine, Deltametrine 50 Carbamates Muscle HPLC-Fluorine 50 (5) 71 B2-e Non Steroidal Fenilbutazone Muscle HPLC-DAD 18 36 71 Antiinflammatories B3-a Organochlorinated Organochlorinated Fat GC-ECD (6) (7) 32 Compounds B3-B Organophosphorated Organophosphorated Fat GC-TSD (8) 200 33 Compounds Lead AAS-gsf 10 100 B3-c Cadmium AAS-gsf 10 50 Muscle 32 Chemical Elements Mercury AAS/hg 10 1000 Arsenic AAS/hg 50 1000 B1 B3-d B2 Aflatest/ Aflatoxines Liver 0,3 5 32 Mycotoxins G1 HPLC- Fluorine G2 (1) Amoxicyllin (HPLC): 25 ppb ; Tetracycline (HPLC): 50 ppb; Erytromicine (HPLC): 100 ppb

(2) Amoxicyllin: 50 ppb; Tetracycline: 100 ppb; Erytromicine: 200 ppb

(3) Sulfatiazole, Sulfadiazine, Sulfamerazine, Sulfametazine, Sulfadimetoxine, Sulfaquinoxaline: 10 ppb.

(4) Febendazole: 500 ppb, Albendazole: 1000 ppb, Mebendazole :400 ppb, Oxibendazole: 200 ppb

(8) Diazinon, Clorpiriphos metil, Clorpiriphos etil, Fenthion, Bromophos etil, Bromophos metil, Ethion, Parathion etil: 20 ppb; Fenclorphos, Fenitrothion, Dimetoato: 30 ppb.

(*) Ciprofloxacine and Enrofloxacine: 2 ppb ** Will be implement during the second semester, 2007 *** Will be implement during the second semester, 2007

5.3.4.4 Residues of Group A substances in turkey meats

L. Detection L. of action N° Residue Category Residues Matrix Methods (ppb) (ppb) Samples

Dietilestylbestrol

A1 Liver GC-MS 1 1 Stilbenes Hexestrol 39 Dienestrol Trembolone Acetate

Liver ELISA/GC-MS 2 2 19 17-B-Stradiol A3 Steroids Nandrolone** Boldenone** Liver GC-MS 2 2 19 Methyltestosterone** Progesterone**

A4 Zeranol (1) Resorcilinic Acid By- Liver ELISA/GC-MS 2 2 39 product Clembuterol Cimaterol, A 5 Terbutalina, Liver LC- MS-MS 1 1 B-Adrenergics Zilpaterol, 24 Ractopamine, Mapenterol

Chloramphenicol Muscle LC- MS-MS 0,3 0,3 11 A6 Substances included Nitrofurans (2) Muscle LC- MS-MS 0,5 1 13 in Annex IV

Nitroimidazoles (3) Muscle LC- MS-MS 1 1 13

5.3.4.5 Residues of Group A substances in live turkeys

Samples in Residue Category Residues Matrxz Method L. Detection Farms

Dietilestylbestrol

A1 3 ppb Hexestrol Serum GC-MS Stilbenes Dienestrol Trembolone Acetate- 17-B-Stradiol A3 Nandrolone** 23 Serum ELISA/GC-MS 2 ppb Steroids Boldenone** Methyl- testosterone** Progesterone** A4 Resorcilinic Acid By- Zeranol (1) Serum ELISA/GC-MS 2 ppb products A5 Clembuterol Feathers ELISA/GC-MS 5 ppb 23 B-Adrenergics

(1) During the second semester Taleranol (2 ppb) analysis will be included ** Will be implement during the second semester of 2007. 24

5.3.4.6 Residues of group B substances in turkey meats L. L. Detection N° Residue Category Residues Matrix Method Action (ppb) samples (ppb) Antibiotics Muscle 4 Plates (1) (2) 23

Sulphas Liver HPLC-Fluorine (3) 100 25 B1 Antibacterian Quinolones (*) Muscle HPLC-Fluorine 2 100 22 Substances Lyncomicin Muscle HPLC-DAD 50 100 22

Bacitracin** Muscle HPLC 10 *** 24 Ivermectin Liver HPLC-Fluorine 7,5 15 10 Levamizol** Liver HPLC 50 100 8 B2 –a Antihelmintics Bencimidazoles Liver HPLC-DAD 200 (4) 7

Salinomicine Muscle HPLC-DAD 45 50 8

Amprolio Muscle HPLC-DAD 100 200 5

Nicarbacine Muscle HPLC-DAD 100 200 5 B2-b Anticoccidials Clopidol Muscle HPLC-DAD 2500 5000 4

Tortrazuril** Muscle HPLC-DAD 50 100 8 Cypermetrine, α-Cypermetrine, 200 Fenvalerato, B2-c Esfenvalerato Fat GC-ECD 10 13 Piretroids and Permetrine, Cyalotrine 500 Carbamates Cyflutrine, Deltametrine 50 Carbamates Muscle HPLC-Fluorine 50 (5) 13 B2-e Non Steroidal Fenilbutazone Muscle HPLC-DAD 18 36 13 Antiinflammatories B3-a Organochlorinated Organochlorinated Fat GC-ECD (6) (7) 6 Compounds B3-B Organophosphorated Organophosphorated Fat GC-TSD (8) 200 6 Compounds Lead AAS-gsf 10 100 B3-c Cadmium AAS-gsf 10 50 Muscle 6 Chemical Elements Mercury AAS/hg 10 1000 Arsenic AAS/hg 50 1000 B1 B3-d B2 Aflatest/ Aflatoxines Liver 0,3 5 6 Mycotoxins G1 HPLC- Fluorine G2 (1) Amoxicyllin (HPLC): 25 ppb ; Tetracycline (HPLC): 50 ppb; Erytromicine (HPLC): 100 ppb

(2) Amoxicyllin: 50 ppb; Tetracycline: 100 ppb; Erytromicine: 200 ppb

(3) Sulfatiazole, Sulfadiazine, Sulfamerazine, Sulfametazine, Sulfadimetoxine, Sulfaquinoxaline: 10 ppb.

(4) Febendazole: 500 ppb, Albendazole: 1000 ppb, Mebendazole :400 ppb, Oxibendazole: 200 ppb

(8) Diazinon, Clorpiriphos metil, Clorpiriphos etil, Fenthion, Bromophos etil, Bromophos metil, Ethion, Parathion etil: 20 ppb; Fenclorphos, Fenitrothion, Dimetoato: 30 ppb.

(*) Ciprofloxacine and Enrofloxacine: 2 ppb ** Will be implement in second semester of 2007. *** Will be implement during the second semester, 2007.

5.3.5 Residue Control Plan in Game Animals

Residues to be determined for the year 2007 are those defined for wild hunting in Decision 97/747/CE of October 27, 1997, which establishes that wild hunting is only affected by chemical elements.

5.3.5.1 Residues control plan in hare meats

L. Detection L. of Action RESIDUES MATRIX METHOD N (ppb) (ppb) Heavy Metals Lead Liver AAS-gsf 10 500 100 Cadmium Muscle AAS-gsf 10 50

5.3.5.2 Residues Control Plan in guanaco meats

L. Detection L. of Action RESIDUES MATRIX METHOD N (ppb) (ppb) Heavy Metals Lead Liver AAS-gsf 10 500 10 Cadmium Muscle AAS-gsf 10 50

5.3.6 Residues Control Plan for Honey

Residues to be analyzed were selected based on the Communitarian Decision 97/747, considering that products used in national apicultural handling and requirements of destination markets.

L. detection L. action N° de Residue Category Residue Matrix Method (ppb) (ppb) Samples Tetracycline 1 sample HPLC- Oxitetracycline** Honey 10 30 until a B1 Fluorine Antibacterian Clortetracycline** maximum Substances HPLC- 22 tons of Sulphas Honey (1) 10 Fluorine exported honey Lead 10 100 B3-c AAS/ Graphito Honey Chemical Elements oven Cadmium 30 50 26

B2-c Fluvalinate Honey GC-ECD 10 50 Piretroids B3-a Organochlorinated Organochlorinated Honey GC-ECD (2) 200 compounds B3-b Organophosphorate Organophosphorated Honey GC-CD/ npd (3) 100 d Compounds

(1) Sulfatiazole, Sulfadiazine, Sulfamerazine, Sulfametoxipiridazine, Sulfaclorpiridazine, Sulfametoxazole, Sulfadimetoxine: 10 ppb.

(2) Alfa BHC, Heptacloro, Heptaclorohepoxide, pp'DDE: 10 ppb; Gama BHC, Aldrin, Beta BHC, Gamaclordano, Dieldrin, Endrin, op’DDD, op’DDT, pp’DDD: 20 ppb; HCB, op’DDE, Alfaclordano, Metoxiclor, pp’DDT: 30 ppb.

(3) Diazinon, Clorpiriphos metil Clorpiriphos etil, Parathion etil, Fenthion, Bromophos metil, Bromophos eti, Ethion: 20 ppb; Fenclorphos, Fenitrothion, Dimetoato: 30 ppb. **Cumafós: 50 ppb.

** Will be implement during the second semester of 2007.

Besides, during the second semester 2007, 30 samples will be analyzed for nitrofurans (0,5 ppb) and for chloramphenicol (0,3 ppb) with LC MS-MS. On the other hand, 20 samples will be analyzed for streptomycin (10 ppb) and 20 samples for amitraz (100 ppb)

5.3.7 Residue Control Plan in Dairy Products

Minimum total amount of samples per year for Chile corresponds to 300 samples. Samples will be collected according to provisions of Directive 97/747. The distribution of samples in each one of the Plants was determined according the reception volume in litters of milk of each one of them.

Detection Action Limit Residue Category Residue Matrix Method Analysis Nº Limit (ppb) (ppb)

A6, ANNEX IV CHLORAMPHENICOL RAW MILK HPLC-MS/MS 0,3 0,3 230

ANTIBIÓTICS Tetracyline RAW MILK HPLC- DAD 20 100 100 Oxitetracycline Clortetracycline

B1,. SULPHAS ANTIBACTERIAN - Sulphatiazole SUBSTANCES - Sulphametazine - Sulphamerazine RAW MILK HPLC-DAD 20 25 100 - Sulphadimetoxine - Sulphacloropiridazine - Sulphametoxazole - Sulphaquinoxaline B2 a, ANTIHELMINTICS Pirlimicin** RAW MILK HPLC 50 100 15

Eritromicine** RAW MILK HPLC 20 40 15

HPLC - IVERMECTIN RAW MILK 10 10 115 Fluorine 27

Detection Action Limit Residue Category Residue Matrix Method Analysis Nº Limit (ppb) (ppb)

BENCIMIDAZOLES Albendazole 100 Thiabendazole RAW MILK HPLC/DAD 10 100 Mebendazole Oxfendazole 10 Fenbendazole

Levamizol** RAW MILK HPLC 10 10 15

B2 e, AINE PHENILBUTAZONE RAW MILK HPLC/DAD 60 60 230

Aldrin 6 6 Dieldrin 6 6 Chlordan 5 5 4,4 DDT 10 10 2,4 DDT 10 10 Hexachlorobenzene 5 100 Endosulfan sulphate 4 4 Alpha endosulphan 4 4 Beta endosulphan 4 4 Dicophol 20 20 Triadimephon 20 20 B3 a, ÓRGANO- RAW MILK GLC-ECD 18 CHLORINATED Vinclozolin 5 5 Heptachloro 4 6 Alpha BHC 5 5 Beta BHC 5 5 Gamma BHC 5 5 4,4 DDE 10 10 4,4 DDD 10 10 2,4 DDD 10 10 Heptachloro alpha 5 5 hepoxide Heptachloro beta 5 5 hepoxide Diazinon 5 10 Chlorpiriphos 5 5 Fenthion 5 5 B3 b, ÓRGANO Disulphoton RAW MILK GLC-NPD 5 5 18 PHOSPHORATED Pirimiphos Metil 5 5

Ethion 5 5 Clorpiriphos Metil 5 5

Pb AA-Flame 20 20

Cd AA-Flame 2 2 B3 c, CHEMICAL RAW MILK 17 ELEMENTS Hg AA-Cold Steam 4 4

AA- Hydride As 10 10 Generation

B3 d, MYCOTOXINS AFLATOXIN M1 RAW MILK HPLC/Fluorine 0,05 0,05 17 28

5.4 MEASURES TO BE ADOPTED IN CASE OF DETECTING A SAMPLE WITH PROHIBITED SUBSTANCES OR OVER ACTION LIMITS (MRL)

In case that an accredited laboratory using quantitative techniques, reports to the Livestock Protection Division a result with presence of residues of prohibited substances or with levels over MRL, following is the procedure to be adopted:

1. The Livestock Protection Division (LPD) will inform the Regional Office the results with detection with levels over MRL or prohibited substances, and this has to inform to the corresponding Sectorial Office, which will formally notify the establishment or farm. Furthermore, LPD will request the identification of the animal origin and will instruct the dispatch of counter-sample to the Central SAG’s Laboratory for its dispatch to the Reference Laboratory.

2. For other hand, the LPD will request the beginning of Predial Investigation to the animal origin Region in order to analyze in situ the possible causes of supposed presence of prohibited residues or of MRL residues, so afterwards, and if corresponding, the LPD instructs actions to be followed. Furthermore, the Regional Office will instruct to the corresponding Sectorial Office to the animal origin, the temporarily suspended official certification of the farm, until that the LPD communicate the results of confirmatory analysis of the counter- sample.

3. The Livestock Protection Division will enter this farm into a Directed Monitoring System that will consist in the collection of five samples of the following slaughtering after notification, samples that will be stored until receiving results of counter-samples mentioned in point Nº 2, above. (This does not apply in the case of honey production).

5.4.1 CASE Nº 1: Negative confirmatory analysis

In the case that the confirmatory analysis of counter-sample sent to the Reference Laboratory, results negative, following is the procedure to be carried out:

1. The Livestock Protection Division will inform the result to the corresponding Regional Office, which will notify to the corresponding farm, leaving without effect the farm suspension.

2. The LPD will instruct to the corresponding Regional Office, the elimination of samples and counter-samples originated since Directed Sampling (point Nº 3 of chapter 5.4).

3. The farm will continue with the Normal Surveillance System.

5.4.2 CASE Nº 2: Positive Confirmatory Analysis of prohibited substances

If counter-sample confirmatory analysis results positive to prohibited substances (over defined action limit), the LPD will instruct to the corresponding Regional Office the elimination of farm from the registry of authorized farms to export to the European Union, instructing to the corresponding Sectorial Office the notification to the owner of farm.

5.4.3 CASE Nº 3: Confirmatory Analysis over Action Limit (MRL)

In case that the confirmatory analysis of the counter-sample sent to the Reference Laboratory, is over defined MRL, following is the way to proceed:

1. The Livestock Protection Division will instruct to the Regional Office dispatch to the Central SAG’s Laboratory for corresponding analysis, of the stored samples, originated after beginning of Directed Monitoring (point 3 of chapter 5.4), to subsequently follow with procedure described in chapter 5.4.4.

2. Corresponding SAG professional will send to the Livestock Protection Division, all antecedents collected during the in situ investigation carried out in affected farm.

3. If the analyses of samples collected during directed monitoring, show the presence of at least one positive sample, the SAG will not certify the authorization to export the lot of animals originated from said farm, to subsequently follow with procedure described in chapter 5.4.4.

4. If results of all 5 samples corresponding to directed monitoring are negative, Normal Surveillance System will continue, as established in the Program.

5. For the case of honey production for exportation, if a beekeeper obtain positive samples results for the Residue Control Program, will be suspended from the Registry of Honey Exporter Beekeepers (RAMEX), for a period of three months, at the end of which, the beekeeper shall request a new analysis. If the result of this analysis is negative, the suspension is leaved without effect, but if the result is positive, the beekeeper will be disqualified to export for a new period of three months. If at the end of this new period and after having carried out a new analysis, it continues resulting positive, the beekeeper will be eliminated from RAMEX. If honey of the same beekeeper shows positive to the same substance, in any other monitoring of the official plan, this beekeeper will be eliminated from RAMEX.

5.4.4 Regularization of the situation

If the farm is in the case of a positive result in the directed monitoring, the following procedure has to be carried out to regulate its situation:

1. As soon as they have been notified of the results of the Directed Monitoring, the farm has to request the Livestock Protection Division to proceed with sampling of the lot of animals to be exported.

2. This samples will be sent in urgent conditions to accredited laboratories net for the Program.

3. This animal lot will be retained and the exportation certification of the animals will only be issued once analysis results have been received.

4. If analysis results are negative, the animal lot will be certified by SAG authorizing its exportation.

5. This procedure described before, will be applied for the following three animal lots to be exported, which after being reported as negative will allow the farm to return to the Normal Surveillance System.

6. If in any of these three consecutive animal lots, a positive result is presented, the farm will be eliminated from the registry of authorized farms to export to the European Union. 31

6. ANNEXES

6.1 ANNEX 1: SAMPLE COLLECTION FORM

Agriculture and Livestock Service Livestock Protection Department

Nª 06-0101 Sample Collection and Laboratory Dispatch Form

1. INFORMATION ON SAMPLE COLLECTION

Sampling date: ………/…………./………..

SURVEILLANCE: ………………………………………………. DIRECTED MONITORING: …………………..

Specie:

CHICKEN PIG TURKEY OVINE BOVINE HARE HONEY OTHER

Sampled Tissue:

MUSCLE FAT LIVER KIDNEY HONEY MILK OTHER

Requested Analysis:

ANABOLICS QUINOLINES HEAVY METALS IVERMECTINE B-ADRENERGICS SULPHAS ORGAN- NITROFURANS CHLORINATED THYROSTATICS ANTICCIDIALES ORGAN CHLORAMPHENICOL PHOSPHORATED ANTIBIOTICS LINCOMYCIN OTHERS

Sample weight ……. Gr/cc

Veterinary Inspector responsible of Sample Collection

Name …………………………………………………. Signature ……………………………………………………………………………….

2. ANTECEDENTS OF SAMPLE DISPATCH

Destination Laboratory ……………………………………………. Region: ………………………………………………………………….

Dispatch Date: …………………………………………………….. Means of Transportation …………………………………………………

3. ANTECEDENTS OF SAMPLE

Slaughtering House or Exporting Establishment: ……………………….Prov/Commune: ……………………… Region: ………………..

Origin Field: ………………………………………………………………. Prov/Commune: ……………………… Region: …………………

Lot Nº: ………………………………………………………… Nº of Carcasses/ Sampling Time: ……………………………………………..

Category: …………………………………………………… Nº of Animals per lot: ………………………………………………………………

ORIGINAL : TO BE SENT TO LIVESTOCK PROTECTION DIVISION, 140 BULNES AVE., 7TH FLOOR, SANTIAGO

Agriculture and Livestock Service Livestock Protection Department

6.2 ANNEX 2 Nª 06-0476

FORM OF RESULTS DISPATCH RESIDUES CONTROL PLAN

1. LABORATORY ANTECEDENTS

Name of the Laboratory …………………………………………… Region …………………

2. SAMPLE ANTECEDENTS

Date of Sample Reception: ………/……/…… Nº Sample ……………………

Specie:

CHICKEN PIG TURKEY OVINE BOVINE HARE HONEY OTHER

Sampled Tissue:

MUSCLE FAT LIVER KIDNEY HONEY MILK OTHER

Requested Analysis:

STILBENES ANTIBIOTICS HEAVY METALS STROGENS SULPHAS ORGAN-CHLORINATED CLEMBUTEROL LINCOMYCIN ORGAN PHOSPHORATED NITROFURANS MACROLIDS OTHERS

3. RESULTS

Nº of Laboratory Analysis ………………………… Analysis Date: ………../ ………./ …….

METHOD DETECTION LIMIT RESULT CHEMICAL (ppb) (ppb) SUBSTANCE

Observations: ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ……………………………………………………………………………………………………………… ………………………………………………………………………………………………………………

Dispatch Date of Result: ……………./ ………………./ …………

Name of Responsible …………………………………………….. Signature …………………………

ORIGINAL : TO BE SENT TO LIVESTOCK PROTECTION DIVISION, 140 BULNES AVE., 7TH FLOOR, SANTIAGO

6.3 ANNEX 3: FORM OF PREDIAL INVESTIGATION

Nº 0003

GOVERNMENT OF CHILE MINISTRY OF AGRICULTURE S A G

INVESTIGATION FORM OF PREDIALS WITH ANTECEDENTS OF DRUG RESIDUES OF VETERINARY USE AND/OR ENVIRONMENTAL CONTAMINANTS

1. FIELD IDENTIFICATION

FIELD NAME: …………………………………………………………………………………………………………

FIELD LOCATION ……………………………………………………………………………………………………

OWNER’S NAME: ……………………………………………………………………………………………………..

OWNER’S ADDRESS: ………………………………………………………………………………………………...

PABCO FIELD ………….. ………………. YES NO

2. SAMPLE IDENTIFICATION

SAMPLE NUMBER ……………………………………………

DETECTED ANALYTE ………………………………………………………………………………………………

3. VETERINARY MEDICINAL PRODUCTS USE Administration of Veterinary Medicinal Products during the last 150 days

Commercial Name Dose Animals Category

………………………………….. …………………………………. …………………………………………… ………………………………….. …………………………………. …………………………………………… ………………………………….. …………………………………. …………………………………………… ………………………………….. …………………………………. …………………………………………… ………………………………….. …………………………………. ……………………………………………

Supplementation with minerals: ……………………………………………………………………………………. …………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………..

4. ENVIRONMENTAL CONTAMINANTS

Type of food used in animals …………………………………………………………………………………………. ……………………………………………………………………………………………………………………………

Type and date of herbicide, pesticides, fertilisers applied in nearby areas ………………………………………. …………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………

Source of water provision ………………………………………………………………………………………….

…………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………

5. OBSERVATIONS:

------

………………………………………… ………………………………………………. Name and signature of Owner’s signature Official Veterinary Inspector In charge of the Farm

Date:

ORIGINAL : TO BE SENT TO LIVESTOCK PROTECTION DIVISION, 140 BULNES AVE., 7TH FLOOR, SANTIAGO 35

6.4 ANNEX 4: REGISTRATION PROCESS OF VETERINARY MEDICINAL PRODUCTS

FLOWSHEET OF REGISTRATION PROCESS OF A VETERINARY MEDICINAL PRODUCT VETERINARY DRUG

FILE SUBMISSION BY USER

General Review of Antecedents: - Legal aspects - Technical-scientific antecedents - Labelling of Project

Approves Entrance Rejects Entrance

Fee Payment of Entered Product producto ingresado SAG Livestock Protection Dept:Lo Aguirre Laboratory,Epidemiology,Parasitology,etc

SERNAPESCA

DISPATCH TO CONSULTANTS Reference Analytic Laboratory (INTA, IDIEF, U. Católica)

OTHERS National & International (Universities, FDA, EMEA)

DRVMPUG UNIT UNI T: Complete study of antecedents and REPORTS analysis of reports

TECHNICAL COMMITTEE:as required. Approval or rejection is proposed

Rejects RESOLUTION OF REGISTRY DENEGATION.

Approves RESOLUTION OF APPROVAL AND SAG REGISTRY AUTHORISATION Nº

6.5 ANNEX 5: RESIDUES CONTROL PROGRAM DIAGRAM

Flowsheet Diagram of Residue Control Program