final report of a mission carried out in botswana from 25

EUROPEAN COMMISSIONHEALTH AND CONSUMERS DIRECTORATE-GENERAL

Directorate F - Food and Veterinary Office

DG(SANCO) 2010-8448 - MR FINAL

FINAL REPORT OF A MISSION

CARRIED OUT IN

BOTSWANA

FROM 25 TO 29 JANUARY 2010

IN ORDER TO EVALUATE THE CONTROL OF RESIDUES AND CONTAMINANTS IN LIVE ANIMALS AND ANIMAL PRODUCTS, INCLUDING CONTROLS ON VETERINARY

MEDICINAL PRODUCTS

Executive Summary

This report describes the outcome of a Food and Veterinary Office mission in Botswana, carried out between the 25 and the 29 January 2010, as part of the published programme of the Food and Veterinary Office inspections on residue controls in third countries.

The objective of the mission was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products, including the controls on the distribution and use of veterinary medicinal products and feed additives, the use of which may give rise to residues in such products. The evaluation was based on the standards set out in Council Directive 96/23/EC, and other relevant Community legislation in this field, including legislation on the control and distribution of veterinary medicinal products. The mission assessed the performance of the competent authorities and other officially authorised entities involved in residues and veterinary medicinal product controls and the legal and administrative measures put in place to give effect to the relevant Community requirements with regard to import of food of animal origin into the EU.

It is concluded that the control systems in place for residues of pharmacologically active substances and veterinary medicines generally provide guarantees equivalent to EU rules. The decision of the competent authorities to sub-contract residues testing to an ISO 17025 accredited laboratory using methods validated according to Commission Decision 2002/657/EC, gives confidence in the residues status of food of animal origin exported to the EU. Whilst there are some minor shortcomings identified such as the lack of any legal obligation for farmers to keep medicines records, these are mitigated by the limited range of medicines available and the distribution system in place. Overall, the sanitary measures in place are capable of providing a level of protection at least equivalent to those required by EU legislation and in line with guidance provided by Codex Alimentarius, guideline CAC/GL 71-2009.

The report makes a number of recommendations to the competent authorities of Botswana, aimed at rectifying the shortcomings identified and enhancing the implementing and control measures in place.

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Table of Contents 1 INTRODUCTION ........................................................................................................................1 2 OBJECTIVES OF THE MISSION .................................................................................................1 3 LEGAL BASIS FOR THE MISSION ................................................................................................2 4 BACKGROUND ..........................................................................................................................2

4.1 COUNTRY STATUS IN RELATION TO COMMISSION DECISION 2004/432/EC ..........................................2 4.2 PREVIOUS MISSIONS RESULTS .........................................................................................................2 4.3 RAPID ALERT SYSTEM FOR FOOF AND FEED (RASFF) .....................................................................2 4.4 PRODUCTION AND TRADE INFORMATION ............................................................................................3

5 FINDINGS AND CONCLUSIONS ...................................................................................................3 5.1 NATIONAL RESIDUES CONTROL PLAN .............................................................................................3

5.1.1 COMPETENT AUTHORITIES INVOLVED ..........................................................................................3 5.1.2 PLANNING OF THE NATIONAL RESIDUE CONTROL PLAN .....................................................................3 5.1.3 IMPLEMENTATION OF THE NATIONAL RESIDUE CONTROL PLAN ............................................................5 5.1.4 CO-ORDINATION OF IMPLEMENTATION OF THE NATIONAL RESIDUE CONTROL PLAN .................................6 5.1.5 FOLLOW-UP OF NON-COMPLIANT RESULTS ....................................................................................7

5.2 LABORATORIES .............................................................................................................................8 5.3 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS .................................................9

5.3.1 AUTHORISATION OF VETERINARY MEDICINAL PRODUCTS ...................................................................9 5.3.2 DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS ........................................................10 5.3.3 CONTROLS ON THE DISTRIBUTION AND USE OF VETERINARY MEDICINAL PRODUCTS ...............................12

5.4 RESIDUES STATUS OF THE MEAT FROM EQUIDAE .............................................................................13 6 OVERALL CONCLUSIONS .........................................................................................................15 7 CLOSING MEETING ................................................................................................................15 8 RECOMMENDATIONS ...............................................................................................................15ANNEX 1 - LEGAL REFERENCES .................................................................................................16

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ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

BNVL Botswana National Veterinary Laboratory

DG(SANCO) Health and Consumer Protection Directorate General

EU European Union

Group A, B Categories of substances listed in Annex I to Council Directive 96/23/EC

ISO International Organisation for Standardisation

LAC Livestock Advisory Centre

MRL Maximum Residue Limit

RASFF Rapid Alert System for Food and Feed

SOP Standard Operating Procedure

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1 INTRODUCTION

The mission took place in Botswana from 25 to 29 January 2010. The mission team comprised two inspectors from the Food and Veterinary Office. The mission was undertaken as part of the Food and Veterinary Office's planned mission programme, evaluating control systems and operational standards in this sector.

Representatives from the central competent authority accompanied the inspection team during the whole mission. An opening meeting was held on the 25 of January 2010 with the central competent authority and representatives of the central competent authority responsible for the authorisation of veterinary medicinal products. At this meeting, the objectives of, and itinerary for, the mission were confirmed by the inspection team and the control systems were described by the authorities.

2 OBJECTIVES OF THE MISSION

The objective of the mission was to evaluate the implementation of national measures, aimed at the control of residues and contaminants in live animals and animal products, including the controls on the distribution and use of veterinary medicinal products and feed additives, the use of which may give rise to residues in such products. The mission was based on Council Directive 96/23/EC and other relevant Community legislation in this field, including legislation on the control and distribution of veterinary medicinal products.

The mission focussed on the roles of the competent authorities at central and regional levels, the legal and administrative measures in place to give effect to the relevant EU requirements, controls with regard to residues and veterinary medicinal products and their operation, and the performance of residue laboratories. The table below lists sites visited and meetings held in order to achieve that objective.

Meetings/Visits n Comments

Competent Authorities

Central 3 Initial and final meeting

Interim meeting in relation to export of meat from equidae

Regional 1 1 District veterinary office

1 Permit Office in charge of issuing import permits for VMPs

Laboratories 1 BNVL

Farms 2 1 feed lot for bovine

1 farm for bovine

Establishments 5 1 export slaughterhouse

1 wholesaler of veterinary medicinal products

2 Livestock Advisory Centres

1 private retailer for veterinary medicinal products

Interviews 7 3 private veterinary practitioners involved in food-producing animals practice

2 Extension officers

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1 Official veterinarian responsible for controls in the bovine export slaughterhouse not visited during the mission

staff responsible for one slaughterhouse for internal market (part of the Meat Inspection Training Centre)

3 LEGAL BASIS FOR THE MISSION

The mission was carried out under the general provisions of Community legislation, and in particular:

• Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products, and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC;

• Article 46 of Regulation (EC) No 882/2004 of the European Parliament and of the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules;

• Commission Decision 98/140/EC of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries.

A full list of the legal instruments referred to in this report is provided in the Annex and refers, where applicable, to the last amended version.

4 BACKGROUND

4.1 COUNTRY STATUS IN RELATION TO COMMISSION DECISION 2004/432/EC

Commission Decision 2004/432/EC as last amended by Commission Decision 2009/800/EC, indicates that Botswana's Residues Monitoring Plan has been approved in accordance with Council Directive 96/23/EC for bovine meat and farmed game (ostriches).

4.2 PREVIOUS MISSIONS RESULTS

Controls on residues in Botswana were evaluated previously on-the-spot by the Food and Veterinary Office in 1999 (DG(SANCO)/1219/1999). The report of this mission is available on the website of the Directorate-General for Health and Consumers:

.http://ec.europa.eu/food/fvo/rep_details_ec.cfm?rep_id=334

4.3 RAPID ALERT SYSTEM FOR FOOF AND FEED (RASFF)

Since 2007, there have been no RASFF notifications for residues of veterinary medicinal products or contaminants in products of animal origin imported from Botswana. From all consignments of bovine meat or meat products imported, 5.1% were sampled and tested for residues of veterinary medicinal products or contaminants during 2007, 8.0% during 2008 and 4.0% in 2009.

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http://ec.europa.eu/food/fvo/rep_details_ec.cfm?rep_id=334

4.4 PRODUCTION AND TRADE INFORMATION

At the time of the mission, three slaughterhouses were approved for export to the EU (two for bovine and one for ostriches). One of the bovine slaughterhouses was closed for annual maintenance. The other one was visited by the mission team.

Ostrich production was stopped in 2008. The competent authority explained that a government project is in place to promote ostrich farming and that slaughter is expected to re-start in April 2010.

The competent authority has requested to add the meat from equidae to the commodities authorised for export to the EU.

5 FINDINGS AND CONCLUSIONS

5.1 NATIONAL RESIDUES CONTROL PLAN

5.1.1 Competent authorities involved

The Ministry of Agriculture has several Departments, two of which (the Department of Animal Production and the Department of Veterinary Services) have responsibilities under the scope of this mission. The organigramme of the ministry of Agriculture is available in the following website: http://www.moa.gov.bw/downloads/orgstructure_moa.pdf .

The Department of Veterinary Services includes several divisions, described on their website http://www.moa.gov.bw/?dept=dvs. For the scope of this mission, several of these divisions have relevant responsibilities:

– the 36 Livestock Advisory Centres (LACs), acting as retailers for over-the-counter veterinary medicinal products;

– the Field Extension Services, staff of which are responsible for the field work (vaccination campaigns, treatments, clinical examinations, animal identification);

– the Veterinary Research and Laboratory Services, and;

– the Meat Hygiene and Quality Control Division.

The Botswana Meat Commission is an agency of the Ministry of Agriculture, established to promote the livestock industry in Botswana. It purchases and slaughters livestock, processes and sells meat and meat products. Both slaughterhouses approved for export bovine meat to the EU are part of this Agency. Since 2009, a system for integrating feedlots is being developed.

As a member of the Southern African Development Community, Botswana shares partially the legal framework of other members of the Community. Specific national legislation is available on the website http://www.laws.gov.bw/

5.1.2 Planning of the national residue control plan

Legal Requirements Third countries which export live animals or animal products to the European Union are obliged to submit to the European Commission a specific plan setting out the guarantees which it offers as regards the monitoring of the groups of residues and substances referred to in Annex I to Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals

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http://www.laws.gov.bw/

http://www.bmc.bw/

http://www.moa.gov.bw/?dept=dvs

http://www.moa.gov.bw/downloads/orgstructure_moa.pdf

http://www.moa.gov.bw/downloads/orgstructure_moa.pdf

and animal products.

The residue plan should take account of the results of monitoring from the previous year and should be revised annually. Article 29 of said Directive states that guarantees must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 and meet the requirements of Article 11(2) of Directive 96/22/EC. Articles 3 to 7 of Council Directive 96/23/EC deal with the requirements for residue monitoring plans. The levels and frequencies of sampling for residues are specified in Annex IV to Council Directive 96/23/EC and Commission Decision 97/747/EC.

Article 11 of Regulation (EC) No 178/2002, laying down the general principles and requirements of food law, specifies that food and feed imported into the Community for placing on the market within the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent thereto. In relation to maximum levels of residues and contaminants in food, Regulation (EC) No 470/2009 of the European Parliament and of the Council lays down Maximum Residue Limits (MRLs) for residues of pharmacologically active substances in food. Regulation (EC) No 396/2005 lays down maximum residue levels of pesticides in or on food and feed of plant and animal origin. Commission Regulation (EC) No 1881/2006 lays down Maximum Levels (MLs) for contaminants in food. Minimum Required Performance Limits (MRPLs) are defined in Article 4 of Commission Decision 2002/657/EC.

In accordance with Article 29 of Council Directive 96/23/EC, Commission approval of every third country’s residue control plan is necessary if that country is to remain on the list of third countries from which EU Member States may import animals and animal products. The list of countries and commodities with approved residue monitoring plans is in the Annex to Commission Decision 2004/432/EC as last amended by Commission Decision 2008/772/EC.

FindingsThe competent authorities of Botswana have sent to the Commission services a National Residues Control Plan for 2010, together with results for 2009. The plan covers all commodities approved for export (bovine meat and farmed wild game -ratites-) and commodities not exported (meat from ovine, caprine, swine and poultry, and eggs). The competent authority has also implemented a plan for testing live equidae. At the time of the mission there was no industrial slaughter of equidae in the country.

The mission team noted that:

• the competent authority has adopted the Council Directive 96/23/EC as the legal basis for the planning and implementation of the national residues control plan;

• the number of samples for each commodity is based on national production. All relevant groups of substances are covered;

• in relation to the substances tested for, the competent authority provided the mission team with the list of those substances (which were not detailed in the plan submitted to the Commission services). The 2010 plan includes all of the substances authorised in Botswana with one exception (piperazine).

Conclusion on planning of the national residues control plan

The national residues control plan of Botswana complies with the requirements laid down in Council Directive 96/23/EC.

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5.1.3 Implementation of the national residue control plan

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7. Articles 4, 5 and 12 of Council Directive 96/23/EC deal with aspects pertaining to the implementation of the national residue control plan. Sampling requirements are specified in Annex IV to Council Directive 96/23/EC and Commission Decision 97/747/EC and Commission Decision 98/179/EC lays down the rules for official sampling under the national residue control plan. Community methods of sampling for the official control a wide range of residues in products of animal origin are laid down in several pieces of Community legislation: Commission Directive 2002/63/EC (pesticides); Commission Regulation (EC) No 1883/2006 (dioxins and dioxin-like PCBs); Commission Regulation (EC) No 333/2007 (certain chemical elements); Commission Regulation (EC) No 401/2006 (mycotoxins).

FindingsThere is a system in place for individual cattle identification. Cattle imported are branded on the right shoulder with a “NO EU” brand at the point of entry, which excludes them from the chain of production for export. In addition, these cattle are electronically identified and their data logged into the system.


• sampling is carried out by official staff. The sampling covers export slaughterhouses, slaughterhouses for the national market and farms. Instructions cover the age groups and the sex of the animals to be sampled. They also instruct that sampling should cover as many lots (origins) as possible. Targeting criteria do not include other factors, e.g. different types of production (feedlots vs private owners) or the seasonality of preventive treatments;

• districts receive every month the plan for sampling on farms. In the district visited, the plan for January 2010 had been received and implemented. Despite the lack of specific instructions, targeting criteria for the on-farm sampling of bovines and donkeys had been discussed between the officials and the minutes of the meeting were available;

• in relation to sampling in slaughterhouses, official staff responsible for controls in both bovine export slaughterhouses confirmed that once the age and sex group is selected, the animal sampled is strictly selected randomly;

• the export slaughterhouse visited only slaughters EU-eligible animals. The other slaughterhouse processes EU eligible and non-eligible animals (this classification refers to animal health-based regionalisation). The official veterinarian responsible for controls in this slaughterhouse was interviewed during the mission. The segregation system in place ensures that sampling covers both populations;

• the official in charge of one slaughterhouse for the national market was also interviewed during the mission. Sampling had been carried out as required and was fully documented;

• the sampling instructions include instructions to sample animals suspected of containing residues. This is termed the "targeted programme". In both slaughterhouses, for export and for local market, officials had sampled suspect animals. Carcasses had been detained pending results;

• each sample is sealed separately. The cool boxes used for transport are filled with ice packs

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and sealed with one single-use tamper-proof seals;

• samples are sent to the BNVL within 24 hours of sampling. At arrival, the sampling forms are reviewed and any deficiency leads to the rejection of the sample. Forms reviewed at laboratory provided for individual identification of the animal. In the slaughterhouse, the traceability of each sample could be documented to the farm of origin;

• once the samples are accepted, a test is allocated randomly and a request for the sub-contracted laboratory is issued accordingly;

• district offices and the BNVL had a contingency plan in the event of electricity disruptions, in order to secure the cold chain of storage of the samples;

• in relation to the sampling of ostriches, on the 26 November 2009 the competent authority notified the Commission services that the plan submitted for ostriches had not been implemented as planned due to the closure of the slaughterhouse. During the mission, it explained that the population of ostriches was slaughtered in 2008. The Botswana government has put in place a breeding system and the slaughter might start at the end of March 2010;

• the central competent authority stated that consignments of samples are sent to the laboratory every three or four months. During 2009, samples had been shipped on three occasions and the last consignment from 2009 was, at the time of the mission, in the process of being prepared for shipping; When the sub-contracted laboratory provides the results, the Director of the BNVL evaluates the results and notifies the outcome (compliances and non-compliances) to staff responsible in the district zone.

Conclusion on implementation of the national residues control planThe residues monitoring plan has been implemented according to the programme. Instructions in place provide for adequate time and geographical distribution. The random allocation of analyses to samples does not take into account relevant data such as the sex of the animal, production system and likelihood of use or misuse of veterinary medicinal products. This has the potential to undermine the effectiveness of the national residues control plan and does not provide for guarantees equivalent to those laid down in Council Directive 96/23/EC.

5.1.4 Co-ordination of implementation of the national residue control plan

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7. Article 4(2)(b) and (c) of Council Directive 96/23/EC lays the requirements for central competent authorities in co-coordinating the activities of all bodies involved in residues controls.

FindingsThe mission team noted that:

• monitoring of the implementation of the sampling is carried out on a weekly or monthly basis by two divisions of the competent authority (the BNVL and the Meat Hygiene and Quality Control Division);

• in relation to the quality and adequacy of the samples, after arrival to the BNVL, samples

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are registered and inspected. Any suspicion of tampering, insufficient amount of any of the matrices or incorrectly filled sampling forms, will lead to the rejection of the sample. In those cases, relevant staff in charge of sampling are notified in writing and the sampling plan for the following months is modified accordingly. This procedure was fully documented and notifications were also reviewed in the District visited. All samples forwarded to the sub-contracted laboratory were fit for purpose;

• a system for verification of the work in the regional/local services is in place, in the framework of the Quality Assurance Inspection Assessment System of the Department of Veterinary Services. Verification visits are carried out at least once per year. Those visits were documented and copies of the check lists were available in the district visited. The central competent authority explained that a follow-up procedure for the non-compliances found is under development.

Conclusion on co-ordination of implementation of the national residue control planThe verification system in place provides for guarantees on the implementation of the national residues control plan and coordination of related activities at least equivalent to those laid down in EU legislation.

5.1.5 Follow-up of non-compliant results

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Measures to be taken by competent authorities in response to the finding of non-compliant residues results are described in Articles 13, 16, 17, 18, 19, 23, 24, 27 and 28 of Council Directive 96/23/EC.

FindingsEvery bovine animal in Botswana is individually identified by an intra-reticular bolus (in addition to owner's brand, district brand and ear punching). Any animal movement is accompanied by a movement permit, issued by departmental extension officers. For this purpose, the farmer presents the animals to the extension officer, who inspects them and, if satisfied with health status and presence of the bolus, issues a movement permit which reflects the individual bolus number. At this time, a brand certificate and a national identity card are also required to prove ownership of cattle.

During 2008 and 2009, there were no non-compliant results for ostriches (only tested in 2008) and live equidae. For bovine, non-compliant results related to 17-alpha-nortestosterone, zeranol, zilpaterol, and several mycotoxins in feed.


• once a non-compliant result is detected, the Director of the BNVL notifies it to the relevant staff, requesting a follow-up investigation. This might occur some weeks or months after the sampling, due to the fact that testing is carried out in a foreign laboratory;

• the mission team reviewed the files of several non-compliant findings. It was confirmed that follow-up investigations had been carried out immediately after the district officials received the notification. The central competent authority has not developed standard instructions in relation to the content or extent of the investigations. However, all the cases reviewed were complete and well reported. Inspections on the farm of origin of the animals and sampling of the same animal (if not yet slaughtered), of other cattle, feed and water had

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taken place;

• the central competent authority explained to the mission team that findings for 17-alpha-nortestosterone could not be avoided as pregnancies in cows went often undetected due to the type of animal husbandry. Zeranol findings were seasonal during the wet season;

• the competent authority has full enforcement powers. Fines are very high in relation to the average income and the use of forbidden substances can lead to imprisonment, which was considered dissuasive.

Conclusions on follow-up of non-compliant resultsThe identification system in place for bovine animals guarantees the traceability back to the farm of origin and therefore provides for implementation of follow-up investigations and enforcement measures. Follow-up measures are implemented with an effect at least equivalent to those provided for in Directive 96/23/EC.

5.2 LABORATORIES

Legal Requirements Article 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive. Article 15 of Council Directive 96/ Requirements for accreditation of laboratories are also laid down in Point 1.2. of the Annex to Commission Decision 98/179/EC.

The rules for analytical methods to be used in the testing of official samples taken pursuant to Article 15(1) of Council Directive 96/23/EC are laid down in Commission Decision 2002/657/EC – in particular Articles 3, 4, 5 and 6 which cover inter alia, validation requirements and quality control. More specific requirements for analytical methods for certain substances are laid down in the annexes to Commission Regulation (EC) No 1883/2006 (dioxins and dioxin-like PCBs in foodstuffs), Commission Regulation (EC) No 333/2007 (chemical elements in foodstuffs) and Commission Regulation (EC) No 401/2006 (mycotoxins).

FindingsIn 2008, the Commission services noted some deficiencies in the testing capability of the laboratory network under the national residue control plan. In order to address those comments, the competent authority of Botswana decided to subcontract the testing to a foreign laboratory.


• a contract between the BNVL and the subcontracted laboratory is in place, specifying the technical requirements of the testing. The contract is reviewed on a yearly basis and those documents were available during the visit to the BNVL;

• in September 2009, the competent authority of Botswana carried out an audit in the contracted laboratory. The team included the Head of the BNLV and the Head of the Residues Section of the competent authority. The report of this audit was available. The laboratory is accredited to ISO 17025 standard and the methods used for testing residues are validated to Commission Decision 2002/657/EC, or comply with the required performance criteria;

• after the samples arrive at BNVL and are considered suitable, they are stored deep frozen until the batch is ready to be sent to the sub-contracted laboratory. The BNVL has no Laboratory Information Management System (LIMS) in place. It was noted that the

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management of sample-related information was difficult and gathering information on the samples, the date of transfer to the laboratory and, for example, the date of arrival of results, was not always possible;

• the competent authority is implementing a programme to develop the national laboratory network. For this purpose, extensive training is being provided to relevant staff, in Botswana and abroad. Records of those trainings were available. It was noted that the laboratory currently carrying out testing is also providing training and technical support to staff from the BNVL;

• shortly before the mission, a state of the art in LC-MS/MS had been purchased by the BNVL. The competent authority expressed their intention to start developing tests for Group A substances.

Conclusion on laboratoriesThe decision of the competent authorities to carry out official testing in an accredited laboratory, using methods validated to Commission Decision 2002/657/EC, provides additional guarantees on the residues status of the animal products exported to the EU.

5.3 VETERINARY MEDICINAL PRODUCTS AND MEDICATED FEEDINGSTUFFS

5.3.1 Authorisation of veterinary medicinal products

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 and meet the requirements of Article 11(2) of Directive 96/22/EC.

Article 7 of Council Directive 96/23/EC provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration.

According to Article 11(2) of Council Directive 96/22/EC, Member States may not import live animals or animal products from third countries which authorise the use of stilbenes or thyrostats in food producing animals. Member States are also prohibited from importing products of animal origin for human consumption if the animals from which such products have been derived have been treated at any time with either thyrostatic substances, stilbenes, stilbene derivatives, their salts and esters, oestradiol 17β and its ester-like derivatives, and beta-agonists if administered for the purposes of growth promotion.

The relevant provisions in Community law governing the marketing authorisation of veterinary medicinal products are laid down in Articles 5-15, 21-30, 58-62 and 83 of Directive 2001/82/EC and for certain products authorised on a Community-wide basis, in Articles 30-40 of Regulation (EC) No 726/2004. Veterinary medicinal products which are authorised for use in food producing animals may only contain pharmacologically active substances which are listed in Annexes I, II, or III to Council Regulation (EEC) No 2377/90. The use of one specific category of veterinary medicinal product – medicated premixes – is governed by Council Directive 90/167/EEC.


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• there is no national production of veterinary medicinal products. Within the SADC framework, there is a mutual recognition of marketing authorisations for veterinary medicinal products, which means that products sold in Botswana are produced mainly in South Africa and some in Namibia;

• since 2007, the national legislative framework includes the ban on the use of hormonal growth promotants for all food producing species;

• the list of products authorised for import into Botswana was presented to the mission team. It is based on the need to control tick-borne diseases, endemic in the country. It includes some antibiotics, parasiticides and some non-steroidal anti-inflammatory drugs. The total number of active substances was very limited;

• only two substances were authorised for use in bovines and neither has an MRL for this species in the EU: piperazine and phenylbutazone. Of those two substances, the national residues control plan covers phenylbutazone.

Conclusion on authorisation of veterinary medicinal productsThe legal framework on forbidden substances in Botswana provides guarantees equivalent to those referred to in Council Directive 96/22/EC.

5.3.2 Distribution and use of veterinary medicinal products

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 and meet the requirements of Article 11(2) of Directive 96/22/EC.

Article 7 of Council Directive 96/23/EC provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration. Articles 4, 5 and 7 of Council Directive 96/22/EC establishes conditions for the administration of substances, referred to in its Annex II, List B and Annex III, to farm and aquaculture animals.

The relevant provisions in Community law governing the distribution and use of veterinary medicinal products are laid down in Articles 65-71 of Directive 2001/82/EC. Article 67(aa) of Directive 2001/82/EC requires that veterinary medicinal products for food producing animals are only dispensed to the public under a veterinary prescription unless exempted under the conditions laid down in Article 2 of Commission Directive 2006/130/EC.

In respect of medicated premixes conditions governing the distribution and use are laid down in Articles 2, 8 and 9 of Council Directive 90/167/EEC. Production of medicated feedingstuffs can only take place in establishments which have been authorised for the production of feedingstuffs containing additives in accordance with Articles 9, 10, 11 and 13 of Regulation (EC) No 183/2005 and the production process must satisfy the conditions laid down in Annexes I and II to that Regulation.

FindingsAll veterinary medicinal products used in Botswana are imported from South Africa and Namibia. Imports can only take place once an import permit has been issued by the Ministry of Agriculture.

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• the competent authority has in place a system for authorisation of wholesalers, retailers and importers of veterinary medicinal products. The authorisation, from the Director of Veterinary services, expires at the end of each year and can be renewed on application;

• before approval, feed mill operators submit details on the type of feedingstuff to be manufactured, formulas or source of raw materials. The national ban on the use of specified hormones, growth promoters, thyrostatic compounds and beta agonists applies to feed producers, together with the prohibition to use proteins of animal origin. Similarly to veterinary medicinal products, there is no national production of complementary feedingstuffs, and all vitamins and minerals to be mixed in feedingstuffs are imported, requiring an import permit;

• veterinary medicinal products are divided into prescription-only and over the counter medicines. This later group includes basic products required for prevention and treatment of tick-borne diseases (sulphonamides and tetracyclines, acaricides and one non-inflammatory drug);

• distribution of prescription-only medicines is restricted to two wholesalers in the country and private veterinary practitioners. When a farmer intends to use one of those products, a veterinary prescription is required. The competent authority noted that the use of prescriptions is anecdotal because, when the need rises, the private practitioner will have the medicine and administer it;

• distribution of over-the-counter medicines is carried out via two commercial structures: private retailers and the LACs;

• in the wholesaler and retailers visited, products in stock were labelled as required and the information on labels and/or leaflets was complete. Only one product containing piperazine was lacking information on the withdrawal period. This information was available in the vademecum. Responsible staff were well informed on the availability of medicines and the drugs which could not be imported into Botswana;

• in all retailers visited, private and governmental, staff met were aware of requirements for use of each medicine, and were trained to provide detailed information to the farmers;

• there are no legal requirements for keeping records of transactions of veterinary medicinal products in wholesalers, retailers or veterinary practitioners. However, records on the transactions carried out were kept in most of the operators visited;

• in relation to the use of veterinary products on farm, private practitioners met kept records of the medicines used. They explained that those records are not kept on farm;

• the meat export company is developing a production system whereby animals bought at farms are finished in company-managed feedlots. On arrival, animals are treated against external parasites, to avoid the need for further treatments against tick-borne diseases. The feedlots are tick-free areas. In addition, since late 2009 the company has required records to be kept individually in case a treatment is needed. Animals under treatment are kept in separate pens until the end of the withdrawal period;

• in the farm visited, records were in place. Treatments had routinely been applied and recorded by the Extension Officer;

• official staff and private operators met during the mission were well aware of which products were over-the-counter and the requirements on withdrawal periods. It was noted that, in general, extension officers were required by farmers to apply those medicines, due to

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their expertise and the fact that the service is free of charge. Those extension officers are also in charge of issuing movement permits to the animals.

Conclusions on distribution and use of veterinary medicinal productsThe system for imports and distribution of veterinary medicinal products and feedingstuffs, together with the government-controlled distribution of over-the-counter medicines, provides for guarantees equivalent to those referred to in the EU legislation, specifically in Article 2 of Commission Directive 2006/130/EC. In relation to the use of veterinary medicinal products, the lack of compulsory records on farm is compensated by (i) the good manufacturing practices established by the beef industry and private veterinary practitioners and (ii) the solid information and education policy in place.

5.3.3 Controls on the distribution and use of veterinary medicinal products

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 which provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration. Article 10 of Council Directive 96/23/EC lays down the veterinary medicines record keeping requirements for stock-owners.

The relevant provisions in Community law governing competent authorities' obligations to carry out inspections throughout the distribution chain of veterinary medicinal products in order to verify compliance with the provisions of the Community code relating to veterinary medicinal products (Directive 2001/82/EC) are laid down in Articles 65, 66, 68, 69 of that Directive. With regard to ensuring that the production of medicated feedingstuffs is in accordance with Council Directive 90/167/EEC, the rules governing control functions by the competent authorities are laid down in Articles 4, 9 and 13 of said Directive.

As third countries' national residue control plans must provide guarantees with an effect equivalent to those established in Directive 96/23/EC, it is necessary that third countries' systems governing the distribution, placing on the market and administration of veterinary medicinal products (as laid down in Article 7 of the Directive) also provide guarantees in line with those offered by EC legislation, particularly in relation to the use and control of the substances included in Annex I to Directive 96/23/EC in animals and animal products intended for export to the EU.


• approvals of wholesalers and retailers of veterinary medicinal products are granted after an inspection visit takes place and the outcome is positive. The authorisation lasts for one year, and a new visit is carried out for renewal. A copy of the outcome of those visits and the authorisation were available in the operators visited;

• the competent authority has developed check lists for the inspections on wholesalers, retailers and farms. The check-list had been used in all the operators visited by the mission team;

• inspections are carried out by several officials at a time. In the wholesaler visited, the

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check-list had been signed by all the officials involved. However, in one retailer visited, each of the three officials signed one check list. The three documents varied in the outcome. It was noted that there were no instructions for the official staff on the evaluation criteria;

• under the import permit system, operators apply to the Veterinary services every time that need to buy (import) a veterinary medicinal product. In the applications they detail the product, the presentation, the quantity and the place of purchase. All forms reviewed by the mission team in the Permit Office were adequately filled. The competent authority issues an import permit which includes all the details and is the document to be presented to Customs officers at the border;

• if the application for import includes prescription-only medicines, the applicant is required to have employed a full time veterinarian or equivalent, or to present a veterinary prescription. For manufacturing of animal feeds, the credentials of a nutritionist in charge of the operations, should also be submitted with the application. There were no applications for import of veterinary medicinal products intended for use in feedingstuffs during 2009. In addition to administrative staff in charge of issuing certificates, there was permanently a veterinarian on call, to clarify technical concerns for the drugs;

• the current permits system is paper-based and did not allow the immediate retrieval of data. Staff could not generate during the visit an updated list of authorised importers;

• extension officers met explained that they visit the farms under their responsibility more that once a week. When visiting farms for training or advice purposes, they do not leave records. Visits with preventive treatments (vaccinations, tick-related controls) or animal management activities (identification, census) are documented.

Conclusions on official controls on the distribution and use of veterinary medicinal products

The control system over the distribution chain of veterinary medicinal products is not fully developed. However, the competent authority has sufficient knowledge of and control over the veterinary medicinal products that are sold and used within the farming sector. This is reinforced by the current policy to educate primary producers and the controls on imports, which overall provide guarantees on the adequate distribution and use of veterinary medicinal products equivalent to those laid down in Article 7 of Directive 96/23/EC.

5.4 RESIDUES STATUS OF THE MEAT FROM EQUIDAE

Legal RequirementsArticle 29 of Council Directive 96/23/EC states that guarantees offered by residue monitoring plans submitted by third countries must have an effect at least equivalent to those provided for in the Directive and must, in particular, meet the requirements of Article 4 and specify the particulars laid down in Article 7 which provides for legislation on the use of (pharmacologically active) substances listed in Annex I to the Directive and, in particular, provisions on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration. Article 10 of Council Directive 96/23/EC lays down the veterinary medicines record keeping requirements for stock-owners

Equidae which are eligible for human consumption, when treated with pharmacologically active substances listed in Annexes I, II or III to Council Regulation (EEC) No 2377/90, must have this treatment recorded in a medicines record kept on the farm as required by Article 10 of Council Directive 96/23/EC.

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There is also more specific Community legislation governing the administration of veterinary products to such animals. Commission Regulation (EC) No 1950/2006 lists certain pharmacologically active substances which are deemed to be essential for the treatment of equidae and even though they are not listed in Annexes I, II or III to Council Regulation (EEC) No 2377/90, these substances may also be used to treat equidae intended for human consumption. Such treatment must also be recorded in Part 3 of Section IX of the equine passport and a period of six months from the date of last treatment to time of slaughter must be observed. The format of the passport (identification document) is laid down in Commission Decision 93/623/EEC and Commission Decision 2000/68/EC. From 1 July 2009, Commission Regulation (EC) No 504/2008 requires that all equidae must be accompanied by an identification document.

If equidae are treated with a substance which is neither listed in Annexes I, II or III to Council Regulation (EEC) No 2377/90 nor defined as an essential substance by Commission Regulation (EC) No 1950/2006, such a treatment permanently excludes the animal from the food chain. Exclusion from the food chain must be declared by the horse owner under Part 2 of Section IX of the equine passport.

FindingsThe current population of donkeys kept in Botswana is estimated by the competent authority to be about 170.000. Up to the time of the mission there had been no slaughter of equidae in the country. Within a plan to develop a new farming activity, the government will acquire donkeys from the farmers and keep them in feedlots for at least three months until they are ready for slaughter. In order to comply with EU requirements, as an initial phase, a national residue control plan in live animals is currently being implemented.


• donkeys are branded with the owner's brand and the crush (area) brand. When an animal changes the owner, a new brand is put in place and the previous one is annuled. This identification provides for traceability of the animal to the last owner and to the previous farms;

• the competent authority has the information on the veterinary medicinal products imported into Botswana and authorised for use in equidae;

• the slaughterhouse where donkeys will be slaughtered for export is an already EU-approved facility, which is undergoing refurbishment and will be operational in April 2010;

• the plans from the competent authority to keep the equidae in feed lots for at least three months would provide for food chain information for this period. It does not fulfil the six months withdrawal period required in the case of treatments with medicines essential for equidae listed in Regulation (EC) No 1950/2006;

• District veterinarians and extension officers stated that donkeys are not treated. This was confirmed by the veterinary practitioners met during the mission, who explained that treatments are not applied to donkeys, due to (i) the reduced number of medical problems and (ii) the cost of the medicine, which is often higher than the value of the animals.

Conclusion on the residues status of meat from equidaeThe competent authority plans to address EU residues requirements for the production of donkey meat will, when fully implemented, provide guarantees with an effect equivalent to those provided for by EU rules.

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6 OVERALL CONCLUSIONS

The control systems in place for residues of pharmacologically active substances and veterinary medicines generally provide guarantees equivalent to EU rules. The decision of the competent authorities to sub-contract residues testing to an ISO 17025 accredited laboratory using methods validated according to Commission Decision 2002/657/EC, gives confidence in the residues status of food of animal origin exported to the EU. Whilst there are some minor shortcomings identified such as the lack of any legal obligation for farmers to keep medicines records, these are mitigated by the limited range of medicines available and the distribution system in place. Overall, the sanitary measures in place are capable of providing a level of protection at least equivalent to those required by EU legislation and in line with guidance provided by the Codex Alimentarius, guideline CAC/GL 71-2009.

7 CLOSING MEETING

A closing meeting was held on 29 January 2010 with representatives of the central competent authority. At this meeting, the mission team presented the main findings and preliminary conclusions of the mission. The authorities did not express disagreement and stated that they would take what ever actions were necessary in order to (i) address the recommendations of the report and (ii) provide adequate guarantees in order to get authorisation for exporting meat from equidae to the EU.

8 RECOMMENDATIONS

The competent authorities are invited to provide details of the actions taken and planned, including deadlines for their completion ('action plan'), aimed at addressing the recommendations set out below, within one month of receipt of this mission report.

N°. Recommendation

1. To consider using targeting criteria laid down in point 2.3.3. of the Annex to Commission Decision 98/179/EC when allocating analyses to the samples under the national residues control plan.

2. To establish and implement a legal framework for record keeping of veterinary medicinal treatments applied to food producing animals to give an effect equivalent to that foreseen in Artcile 10 of Council Directive 96/23/EC.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/fvo/ap/ap_bw_2010-8448.pdf

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http://ec.europa.eu/food/fvo/ap/ap_bw_2010-8448.pdf

ANNEX 1 - LEGAL REFERENCES

Legal Reference Official Journal Title

Audits by the Commission Services

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Dec. 98/140/EC OJ L 38, 12.2.1998, p. 14-16

98/140/EC: Commission Decision of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in third countries

Food Law

Reg. 178/2002 OJ L 31, 1.2.2002, p. 1-24

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety


Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs


Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

Residues Monitoring and Sampling

Dir. 96/23/EC OJ L 125, 23.5.1996, p. 10-32

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC

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Dec. 97/747/EC OJ L 303, 6.11.1997, p. 12-15

97/747/EC: Commission Decision of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products

Dec. 98/179/EC OJ L 65, 5.3.1998, p. 31-34

98/179/EC: Commission Decision of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products

Approval of residues monitoring plans submitted by third countries

Dec. 2004/432/EC OJ L 154, 30.4.2004, p. 44-50, corrected and re-published in OJ L 189, 27.5.2004, p. 33

2004/432/EC: Commission Decision of 29 April 2004 on the approval of residue monitoring plans submitted by third countries in accordance with Council Directive 96/23/EC

Validation of analytical methods for residues

Dec. 2002/657/EC OJ L 221, 17.8.2002, p. 8-36

2002/657/EC: Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results

Bans on the use of hormones and beta-agonists for growth promotion in food producing animals

Dir. 96/22/EC OJ L 125, 23.5.1996, p. 3-9

Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC

Maximum Residue Limits for veterinary medicines in food of animal origin

Reg. 470/2009 OJ L 152, 16.6.2009, p. 11-22

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation

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(EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council

Maximum Residue Levels for pesticides in food of animal origin

Reg. 396/2005 OJ L 70, 16.3.2005, p. 1-16

Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC

Maximum Limits for contaminants

Reg. 1881/2006 OJ L 364, 20.12.2006, p. 5-24

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs

Authorisation of veterinary medicinal products

Dir. 2001/82/EC OJ L 311, 28.11.2001, p. 1-66

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products

Dir. 2006/130/EC OJ L 349, 12.12.2006, p. 15-16

Commission Directive 2006/130/EC of 11 December 2006 implementing Directive 2001/82/EC of the European Parliament and of the Council as regards the establishment of criteria for exempting certain veterinary medicinal products for food-producing animals from the requirement of a veterinary prescription

Reg. 726/2004 OJ L 136, 30.4.2004, p. 1-33

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Medicated feedingstuffs and additives

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Dir. 90/167/EEC OJ L 92, 7.4.1990, p. 42-48

Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community

Reg. 1831/2003 OJ L 268, 18.10.2003, p. 29-43

Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition

Reg. 183/2005 OJ L 35, 8.2.2005, p. 1-22

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene

Sampling methods and methods of analysis for contaminants in foodstuffs

Reg. 333/2007 OJ L 88, 29.3.2007, p. 29-38

Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs

Reg. 401/2006 OJ L 70, 9.3.2006, p. 12-34

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs

Reg. 1883/2006 OJ L 364, 20.12.2006, p. 32-43

Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs

Sampling methods for pesticides in foodstuffs

Dir. 2002/63/EC OJ L 187, 16.7.2002, p. 30-43

Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC

Horse identification (passport)

Dec. 2000/68/EC OJ L 23, 28.1.2000, p. 2000/68/EC: Commission Decision of 22 December 1999 amending Commission Decision

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72-75 93/623/EEC and establishing the identification of equidae for breeding and production

Reg. 504/2008 OJ L 149, 7.6.2008, p. 3-32

Commission Regulation (EC) No 504/2008 of 6 June 2008 implementing Council Directives 90/426/EEC and 90/427/EEC as regards methods for the identification of equidae

Reg. 1950/2006 OJ L 367, 22.12.2006, p. 33-45

Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae

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final report of a mission carried out in botswana from 25

Documents