In response to information provided by the competent authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6635

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

ROMANIA

FROM 16 TO 27 SEPTEMBER 2019

IN ORDER TO

EVALUATE THE IMPLEMENTATION OF THE MONITORING AND ERADICATION MEASURES FOR BOVINE SPONGIFORM ENCEPHALOPATHY (BSE), FEED BAN

RULES, AND CORRECTIVE MEASURES TAKEN TO ADDRESS RECOMMENDATIONS FROM PREVIOUS AUDITS ON BSE AND ANIMAL BY-

PRODUCTS (ABP)

Ref. Ares(2020)2796428 - 29/05/2020

I

Executive Summary

This report describes the outcome of an audit carried out in Romania from 16 to 27 September 2019 as part of the European Commission’s Directorate-General for Health and Food Safety published work programme.

This audit was carried out in connection with the Romanian application for review of its bovine spongiform encephalopathy (BSE) monitoring programme pursuant to Article 6(1b) of Regulation (EC) No 999/2001 of the European Parliament and of the Council and is part of a series of audits aimed at evaluating the implementation of the monitoring and eradication measures for BSE and feed ban rules. This audit paid particular attention to the implementation of corrective measures taken to address recommendations from previous audits on BSE and animal by-products (ABP) which identified deficiencies in enforcement of these aspects of EU legislation in Romania, notably concerning bovine animals identification, BSE monitoring and the system for collection of ABP, including specified risk materials.

With regard to Romania's application for review of its BSE monitoring programme it is concluded that, despite some positive trends observed, there are yet no grounds to allow for the frequency of testing to be relaxed.

On the implementation of corrective measures taken to address recommendations made in previous audits, some progress in addressing the recommendations of the previous BSE audit has been made only recently (as of 2017), whilst the ABP collections system has significantly deteriorated, resulting in recommendations from both audits remaining unaddressed.

Whilst the bovine identification and registration system is in place and official controls on identification are carried out regularly, the system lacks effectiveness due to underreporting of events, mostly from backyard holdings (keeping 90% of the bovine population), the absence of regular follow-up on non-compliances identified and lack of analysis of the available data. In consequence, despite steadily increasing trends in the number of tested samples and some improvement in the functioning of the laboratory network, a certain proportion of eligible bovine animals remains not sampled and, consequently, not tested.

The only area covered by this audit, relevant for supporting Romania’s application and where official controls have been satisfactorily implemented for the last six years and are effective, concerns the feed ban.

The existing system for ABP controls, which lacks a sustainable mechanism for regular collection and disposal of ABP, is not able to ensure that ABP (originating at backyard holdings as a result of home slaughter), including fallen animals, are effectively collected and disposed of. Moreover, the current situation raises serious doubts whether ABP from the meat and the retail sector are collected and disposed of as required. The official controls have been ineffective in verifying and enforcing operators' compliance with the relevant requirements in this regard.

The report contains recommendations to the Romanian authorities to address the shortcomings identified.

II

Table of Contents

1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

3 Legal Basis .....................................................................................................................................2

4 Background ....................................................................................................................................2

4.1 Application for the revision of the BSE monitoring programme ............................................2

4.2 Follow-up on recommendations of previous Commission audits on BSE and ABP ..............3

4.3 Statistical and Background Data .............................................................................................3

5 Findings and Conclusions ..............................................................................................................4

5.1 Competent authorities..............................................................................................................4

5.2 Bovine identification and registration .....................................................................................5

5.2.1 Process for identification of bovine animals....................................................................5

5.2.2 Official controls ...............................................................................................................7

5.2.3 Bovine passports ..............................................................................................................8

5.2.4 Computerised database....................................................................................................8

5.3 BSE monitoring system, laboratory network and testing arrangement .................................10

5.3.1 BSE monitoring in sub-population of healthy slaughtered animals ..............................12

5.3.2 BSE monitoring in the sub-population of animals emergency slaughtered and found sick at ante mortem inspection.....................................................................................................13

5.3.3 BSE monitoring in sub-population of dead animals (fallen stock) ................................14

5.3.4 BSE monitoring in sub-population of BSE suspects ......................................................16

5.3.5 Laboratory and testing arrangement .............................................................................16

5.4 Prohibition concerning animal feeding – Feed ban...............................................................18

5.5 Follow-up of recommendations from previous Commission audit .......................................20

5.5.1 Audit report DG(SANCO)2011-8950 on BSE................................................................20

5.5.2 Audit report DG(SANCO)2011-8941 on ABP ...............................................................21

6 Overall Conclusions .....................................................................................................................25

7 Closing Meeting ...........................................................................................................................25

8 Recommendations ........................................................................................................................25

III

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

ABP Animal by-products

BSE Bovine spongiform encephalopathy

CSVFSD(s) County Sanitary Veterinary and Food Safety Directorate(s)

GDAHW General Directorate for Animal Health and Welfare

GDOC General Directorate for Official Control

GDFS General Directorate for the Food Safety

DG Directorate-General

IDAH Institute of Diagnostic and Animal Health

LIMS Laboratory Information and Management System

NRL National Reference Laboratory

NSVFSA National Sanitary Veterinary and Food Safety Authority (Autoritatea Nationala Sanitar-Veterinara si pentru Siguranta Alimentelor)

PAP Processed Animal Protein

SNIRA National Database for Animals Identification

SRM Specified Risk Material

TSE Transmissible spongiform encephalopathy

1

1 INTRODUCTION

This audit took place in Romania from 16 to 27 September 2019 as part of the European Commission’s Directorate-General for Health and Food Safety planned work programme. The audit team comprised three auditors from the Health and Food Audits and Analysis Directorate.

The audit team was accompanied throughout the audit by the representatives of the central competent authority, the National Sanitary Veterinary and Food Safety Authority (Autoritatea Nationala Sanitar-Veterinara si pentru Siguranta Alimentelor), hereafter: NSVFSA.

An opening meeting with the competent authorities was held on 16 September 2019, during which the audit team confirmed the objectives of, the itinerary and reporting procedures for the audit.

2 OBJECTIVES AND SCOPE

The objectives of the audit were:

1) in the context of the Romanian application for the revision of the Bovine Spongiform Encephalopathy (BSE) monitoring programme pursuant to Article 6(1b) of Regulation (EC) No 999/2001 of the European Parliament and of the Council, to evaluate whether the eradication, control and prevention measures, including the BSE monitoring programme put in place by the competent authority of Romania are implemented in accordance with the relevant requirements of the said Regulation for at least the last six years, and

2) the follow-up of the recommendations that remain open from the two previous audit reports, namely DG(SANCO) 2011-8950 on BSE and DG(SANCO) 2011-8941 on animal by-products (ABP).

In terms of scope, the audit focused on:

1) Elements of the official controls system that are relevant for monitoring and eradication of BSE, namely:

a. a system for the identification and registration of bovine animals as an essential tool for the BSE control measures,

b. an arrangement for sampling and examination of bovine animals, with particular attention to risk groups like fallen stock, animals found sick at ante-mortem inspection and/or presenting clinical symptoms consistent with BSE (suspects), and

c. measures on prohibitions concerning animal feeding, including a detailed description of the enforcement of the feed ban for farmed animals and including the sampling plan and results, the number and type of infringements found and the follow-up actions taken.

2

2) Measures put in place for handling of ABP originating at animal holdings, with particular focus on specified risk material (SRM) derived from bovine animals slaughtered on-farm or found dead on farms.

The itinerary of the audit included the following visits:

Visits/meetings No. Comments

Central 2 Opening and closing meetings

Region (county) 3

Meetings with the competent authorities from three different counties responsible for:

- identification and registration of bovine animals,

- the BSE monitoring and control measures, and

- for controls on handling of ABP

Region (county) 3

Meetings with the county authorities from three different counties responsible for ensuring collection and disposal of ABP and fallen animals from backyard holdings

Laboratories 3Meetings with the county laboratories performing examination of samples for BSE (rapid tests)

Slaughterhouses 2 Slaughtering bovine animals

Incinerators 2 Incinerating ABP

Animal holdings 7

Two commercial holdings with bovine animals and five backyard holdings (four with bovine animals and one with buffalos and other species)

Feed mills 2 Producing feed for farmed animals of different species including bovines

3 LEGAL BASIS

The audit was carried out under the general provisions of EU legislation and, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council and Article 21 of Regulation (EC) No 999/2001.

3

4 BACKGROUND

4.1 APPLICATION FOR THE REVISION OF THE BSE MONITORING PROGRAMME

Regulation (EC) No 999/2001 contains provisions allowing Member States to request a revision of their annual BSE monitoring programmes with a view to reducing the number of tests to be performed. The Annex to Commission Decision 2009/719/EC contains the list of Member States which, at the time of this audit, were authorised to revise their BSE monitoring programmes.

In 2017, Romania submitted to the Commission an application requesting the revision of its BSE monitoring programme aiming at changing the BSE testing regime by reducing the number of tests.

According to Article 6(1b) of Regulation (EC) No 999/2001, a Member State requesting a revision of its BSE monitoring programme must demonstrate, as a prerequisite, an improvement in the epidemiological situation of BSE in the country. The Member State concerned is required to provide proof of its capability to determine the effectiveness of the measures in place and ensure protection of human and animal health based on a comprehensive risk analysis. In particular, the Member State shall demonstrate:

a. a clearly declining or consistently low BSE prevalence, based on up-to-date testing results;

b. that it has implemented and enforced for at least six years a full BSE testing scheme (EU legislation on traceability and identification of live animals and BSE surveillance); and

c. that it has implemented and enforced for at least six years the EU legislation on total feed ban for farmed animals.

Detailed requirements concerning a Member State's application for revision of its BSE monitoring programme are laid down in Point 7 of Section I of Chapter A of Annex III to the said Regulation.

4.2 FOLLOW-UP ON RECOMMENDATIONS OF PREVIOUS COMMISSION AUDITS ON BSE AND ABP

In 2011, the Commission carried out in Romania audits on BSE and on ABP. These audits resulted in a number of recommendations referring to identified non-compliances regarding BSE monitoring and collection and disposal of ABP; in particular, sampling of fallen bovines and collection and disposal of ABP (including SRM) resulting from slaughtering ruminants at backyard farms.

To date Romania presented neither evidence demonstrating that these recommendations have been addressed nor information on the progress made in the implementation of the corrective measures.

4

4.3 STATISTICAL AND BACKGROUND DATA

According to the data provided by the competent authority (1), in 2017 there were 2,231,274 bovine animals in the country. Out of these, 191,438 bovine animals were kept in private companies and associations (commercial and Type-A holdings) and 2,003,971 in backyard holdings, representing 90% of all bovine animals.

According to NSVFSA, there are three types of holdings in Romania: commercial, Type-A and backyard. The conditions applying to different types of holding are as follows:

Condition: Commercial Type-A Backyardlegal entity or legal person X X private person Xsingle species X multi- species X Xrequiring special authorisation (by County Sanitary Veterinary and Food Safety Directorates (CSVFSDs)) X

requiring registration (in the National Database for Animals Identification (SNIRA)) X X

obligatory biosecurity measures X X obligatory contract with private veterinarian X X

obligatory contract for collection and disposal of fallen animals

X X

The audit team noted that the classification as a certain type of holding is not dependent on the number of animals kept in the holding and, consequently, backyard holdings comprise also holdings with a significant number of animals. In the backyard holdings visited there were usually between two to nine bovine animals and also animals of other species: 7 to 15 pigs and 40 to 140 sheep. Nonetheless, the owner of the biggest backyard holding met during the audit kept 68 cows, 100 pigs, a flock of sheep and a horse.

5 FINDINGS AND CONCLUSIONS

Legal acts quoted in this report are provided in Annex 1, and refer, where applicable, to the last amended version. Annex 2 specifies relevant articles or sections of the legislation cited in the report.

5.1 COMPETENT AUTHORITIES

1. The country profile for Romania is available at http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=RO and contains a description of the general organisation and responsibilities for official controls on BSE and ABP.

2. NSVFSA is the central competent authority responsible for all areas covered by this audit.

(1) Data presented in the Romanian Application requesting change of the BSE monitoring system (2017).

5

3. The General Directorate for Official Control (GDOC) of NSVFSA is responsible for the bovine identification and registration system including official controls and maintaining the SNIRA.

4. The General Directorate for Animal Health and Welfare (GDAHW) of NSVFSA is responsible for the organisation of the BSE epidemio-surveillance programme.

5. The General Directorate for the Food Safety (GDFS) of NSVFSA is responsible for ensuring official sampling for BSE testing and proper handling of ABP in slaughterhouses.

6. The GDOC and the GDAHW, together, organise, coordinate and monitor official controls on feed and feed ban at the central level. The Institute of Hygiene and Veterinary Public Health coordinates and supervises the examination of samples collected at the regional level by the CSVFSDs and subsequently examined by the County Sanitary Veterinary and Food Safety Laboratories.

7. The GDOC is responsible for planning and organisation of ABP controls at the central level. At the county level, CSVFSDs carry out controls on ABP operators.

8. The County Councils, representing the central national administration at the county level, are the competent authorities responsible for ensuring collection and disposal of ABP originating at backyard holdings, i.e. from on-farm slaughter and dead animals.

9. County Sanitary Veterinary and Food Safety Laboratories of CSVFSDs, at the county level, carry out BSE examination using rapid tests.

10. The Institute for Diagnosis and Animal Health (IDAH) is the National Reference Laboratory for Transmissible spongiform encephalopathy (NRL-TSE) and carries out BSE rapid tests and confirmatory examinations.

11. In its annual training programme, NSVFSA covers continuous training and awareness actions in the field of BSE. CSVFSA veterinarians, official veterinarians, private veterinary practitioners/authorised veterinarians, bovine breeders, representatives of the meat processing industry and official veterinarians from such industry participate in training sessions by NSVFSA and CSVFSDs. IDAH provides training for the staff of the NRL-TSE, the BSE county laboratories and for official veterinarians from slaughterhouses. Moreover, the Romania College of Veterinarians organises training sessions on various aspects, including on TSE, for private practice veterinarians. This is in line with the requirements of Article 10 of the Regulation (EC) No 999/2001.

12. NSVFSA coordinates training and awareness actions on instructions and guidelines through service notes, videoconferences, contingency plans and other publications (guides, video materials, articles in newspapers or information in mass media). The last training took place at the end of July 2019.

6

5.2 BOVINE IDENTIFICATION AND REGISTRATION

5.2.1 Process for identification of bovine animals

13. The national legislation establishes that the operators of commercial and Type-A holdings identify (apply individual ear tags) bovine animals and register the animals in SNIRA, while authorized veterinarians identify bovine animals at backyard holdings.

14. The identification (ear tagging) of bovine animals shall take place not later than on the 20th day after their birth at the holding of birth, and, in any case, before the animal would leave the holding where it was born.

15. Holding operators and/or authorised veterinarians are responsible for ordering duplicates of lost ear tags for the purpose of retagging.

16. All animal owners shall record, in the holding register, all events related to bovine animals kept at their holdings (e.g., birth, death, purchase, sale and slaughter) and keep these registers up-to-date.

17. The holdings’ operators and authorised veterinarians and slaughterhouses’ operators have the obligation to update the information in SNIRA within 72 hours from the occurrence of the event (purchase, sale, slaughter or death of the animal).

18. With respect to the operators’ and authorised veterinarians’ obligations, the audit team noted that all of the persons met by the audit team, involved in the identification of bovine animals, were aware of their obligations. In the slaughterhouses visited, operators and the official veterinarians entered the relevant data in the database, collected and destroyed ear tags and returned passports to CSVFSDs in a timely fashion.

19. In the commercial holdings visited, the audit team noted the following:

a. The majority of adult bovine animals had two ear tags, some had one ear tag and, in one holding, only one animal was without both ear tags. This animal, however, had an electronic collar allowing linking of the animal with the holding register. Moreover, the holding operator had already in his possession ear tag duplicates also for this cow.

b. With respect to young calves, in one of the holdings, all the young calves had ear tags while in another at least 10 (out of approximately 200 bovine animals) had not. The operator stated that the calves would be tagged soon (new ear tags were available at the holding) and demonstrated how to link the untagged calves to their mothers using the numbers from the calves’ pens and records from the holding birth register.

c. The commercial holdings’ operators and private practice veterinarians notified newborn calves, movements from or to other locations and deaths of animals; however, in one of the two holdings visited, not all of the newborn animals were notified regularly and in a timely fashion.

7

20. In the backyard holdings visited, authorised veterinarians met by the audit team were responsible for ear tagging of bovine animals and, if needed, on behalf of the animals' owners, for completing the relevant identification documents (animal passports and movement documents) and inserting data in SNIRA. The veterinarians met kept the stock of new ear tags and maintained identification documents. However, the audit team noted the following:

a. Out of the five backyard holdings visited, only one had fully completed passports and a complete set of movement documents. In this case, the situation on the holding also matched up the information from SNIRA and both cows had ear tags.

b. In another backyard holding, there were no animals even though SNIRA database indicated the presence of nine bovine animals. Seven passports were available and two were missing and no movement documents "to" and "from" the holding were available. Neither the family representative of the cattle owner (2) nor the authorised veterinarian providing services to this holding were aware of the location where the animals had been moved to.

c. In two other backyard holdings, the owners stated that, on an annual basis, they slaughtered one to two animals for their own consumption. In one of these holdings, the information on a recently slaughtered animal had not yet been entered in SNIRA. On the other holding, the owner stated that he did not apply ear tags to animals that would be slaughtered for own consumption, and therefore did not register them at all.

d. Another owner of one backyard holding had 67 bovine animals (kept in two herds). One of the herds comprised 28 bovine animals of different ages out of which 10 lacked both ear tags. The age of the non-identified animals varied between few months to three years. The owner could present only 38 passports for his 67 bovines. Most of these passports were issued just prior to the visit of the audit team. Information from SNIRA indicated that some of these animals still belonged to the previous owner. The holding owner explained that he had only recently purchased the animals and the transaction had not yet been entirely finalised. However, he could not present any other evidence (e.g., the purchase agreement) supporting the statement. The CSVFSD officials immediately undertook to investigate the situation.

Situations recorded in points c) and d) above constitute non-compliances with Article 4a(1) of Regulation (EC) No 1760/2000 of the European Parliament and of the Council, which requires the owner to identify the bovine animals within a maximum of 20 days.

5.2.2 Official controls

21. NSVFSA stated that each CSVFSD carries out at least two official controls annually on identification of bovine animals; these take place during cross-compliance checks for

(2) According to the statement of the family representative, the owner was working abroad.

8

verification of SRM disposal at farms and during annual inspections in backyard holdings.

22. The CSVFSDs have contracts with authorised veterinarians who carry out controls on animal identification and holdings registration. On a monthly basis, each CSVFSD verifies the reports of these controls submitted by the authorised veterinarians. The verification concerns at least 10% of the holdings submitted to the identification actions. The audit team noted that:

a. The controls by authorised veterinarians take place regularly, every year and cover at least 3% of holdings in the counties.

b. The controls on animal identification and holding registration by authorised veterinarians have a form of an inventory check, cross-checking all animals present in a holding (including bovines) with the status quo report from SNIRA generated prior to the visit.

c. The authorised veterinarians inserted in SNIRA information on mismatches between the SNIRA status quo report and situation found at holdings, e.g., absence of animals recorded in SNIRA or presence of animals not mentioned in the SNIRA report. However, the mismatches identified at holdings have not been investigated further. Lack of adequate follow-up of non-compliances is contrary to Article 22 of Regulation (EC) No 1760/2000.

5.2.3 Bovine passports

23. Article 6 of Regulation (EC) No 1760/2000 requires that whenever a bovine animal is moved between Member States it shall be accompanied by its passport. According to Romanian national legislation, bovine animals must be accompanied by passports also for movements between the holdings within the country.

24. While checking the bovine identification documents in the visited premises, the audit team noted satisfactory compliance with requirements for bovine passports for animals kept at commercial holdings. The operators of both commercial holdings visited had passports for all animals. The information from passports mirrored the information from the holding registers, were complete and kept up to date except for some calves that had died shortly after birth and had been buried in the field (see finding 90.b). In general, both the random inventory checks by the audit team on animals present and the cross-check of movement documents with the data from SNIRA matched up.

25. Contrary to the situation at commercial holdings, there were delays in issuing passports for animals from backyard holdings; in an extreme case, animals with no passport were close to three years old. Moreover, no passports were issued for calves destined for own consumption (see findings 20.b, 20.c and 20.d).

5.2.4 Computerised database

26. According to the data from SNIRA, in the period from 2014 to 2018, the population of bovine animals has steadily declined from 2.4 million to 1.98 million heads. However,

9

the audit team noted that there was a large cohort of bovines missing from the database. For example, in 2018, the difference between the number of animals born and traded (into Romania) and the number of animals slaughtered, dead, traded and exported (out of Romania), resulted in a surplus of approximately 210,000 animals, without known (confirmed) history (3).

27. Records in holding registers and reports from SNIRA analysed by the audit team indicated that events of the same nature (e.g., births, deaths, movement) were recorded in "batches" under the same date while some other available records (movement documents, veterinary registers) referred to other dates. While the majority of events were entered in SNIRA within seven days, the audit team noted that in some cases notifications were made past the seven days deadline or were not done at all (see findings 20.b, 20.c and 20.d). This is not in line with Article 7 of Regulation (EC) No 1760/2000.

28. The owners of the bovine holdings visited, stated that their main activity is the production of milk, and that their cows calve every year. While in 17 counties the numbers of newborn calves registered in SNIRA were plausible, in 13 counties, registered calves represented from 18% to 49% of the expected number. Both in commercial and in backyard holdings visited, the audit team saw evidence of cows immediately sold for slaughter if these were not getting pregnant after a few consecutive inseminations. The audit team noted that the underrepresentation of newborn calves has not been spotted during the official controls.

29. Officials with access to SNIRA can generate some pre-defined, statistical reports. The reports are mostly not editable and only some of them allow for sorting and filtering of data. Tailor-made (targeted) queries are available only on request and mostly from the SNIRA administrator via the central level. The audit team noted that the officials met had rarely used the available reports. Furthermore, the competent authorities (at central, regional or local level) had never requested tailor-made queries to cross-check information relevant for verification on the BSE monitoring, such as the number and location of animals slaughtered (including the ones slaughtered at backyard holdings) and found dead.

30. While visiting and interviewing operators and officials in different counties, the audit team systematically examined the SNIRA functionality and accuracy of the stored data and noted the following:

a. Functionality:

i. SNIRA allows for the entry of multiple data by various operators and its interface, in a user-friendly way, allows generating pre-defined, combined, reports relevant for officials carrying out controls on animals eligible for BSE testing and for controls on ABP (including fallen stock) originating from holdings;

(3) The audit team requested data from SNIRA on animals without confirmed history; however, these data were not provided.

10

ii. Despite the immediate availability of pre-defined queries, which content represents useful and relevant data, more detailed queries can be quickly made available upon request.

b. Accuracy:

i. The information on animals kept at commercial holdings closely matches reality and is usually up-to-date, while there are discrepancies with respect to information related to backyard holdings (based on what was seen on farms and what was inferred from the data extracted from SNIRA by the audit team);

ii. SNIRA already contains records on mismatches identified during annual inspections at backyard holdings which, if used, would be useful for better targeting official controls on animal identification and supervision of the BSE monitoring.

31. The private practice veterinarians met at backyard and commercial holdings visited stated that, in regular circumstances, the expected annual mortality rate at any holding usually ranges from 1% to 3% of the total number of animals on the holding. The table below presents data (from SNIRA) on the mortality rate of bovine animals of all ages, per year, based on the total population and total reported dead animals at backyard and commercial holdings:

Year 2014 2015 2016 2017 2018

Total population 2,540,094 2,450,525 2,294,845 2,147,389 1,984,075

Animals reported dead 5,594 8,293 10,682 12,711 11,748

Mortality rate 0.22% 0.34% 0.47% 0.59% 0.59%

Conclusions on the bovine identification and registration system

32. While SNIRA is operational and available to all relevant users, the data available therein is incomplete for backyard holdings (retaining over 90% of the bovine population) in relation to the sub-populations relevant for the BSE monitoring and as such does not support the BSE monitoring and eradication system.

33. Official controls on identification and registration of bovine animals (inventory checks) are carried out as planned and are able to detect non-compliances, which are subsequently recorded in SNIRA. However, the lack of regular follow-up of these non-compliances weakens the effectiveness of official controls and in turn does not result in any improvement of the reliability of the national database, in particular, with respect to the absence of recorded movements of animals and of notification of newborn calves.

11

34. There is an increasing trend in the number of notified dead animals, indicating growing awareness of this obligation amongst the bovine animal owners; nonetheless, the mortality rate is still just above the half of the lowest expected.

5.3 BSE MONITORING SYSTEM, LABORATORY NETWORK AND TESTING ARRANGEMENT

35. The GDAHW establishes annually the indicators for the minimum number of bovine animals from different sub-populations to be sampled for BSE in each county. These indicators do not limit the collection of samples in a given sub-population but express the probability of statistical occurrence of an animal eligible for sampling. The indicators for sub-populations at risk refer to the total bovine population over 24 months and in 2017 were the following: a) animal found sick at ante-mortem inspection: 0.32%, b) slaughtered in emergency: 0.22%, and c) fallen stock: 0.32%. In 2018, the indicator for the sub-population of animals found sick at ante-mortem inspection remained the same while the ones for bovines slaughtered in emergency and fallen stock increased to 0.24% and 0.40%, respectively. In principle, there are no statistically fixed indicators for the sub-population of BSE suspects, as their numbers cannot be reliably estimated.

36. The Animal Health Service officials of the CSVFSDs instruct authorised and private practice veterinarians on expected numbers of samples and monitor if these are met. The officials pay more attention to bovines found sick at ante-mortem inspection, slaughtered in emergency, fallen animals and suspects as these sub-populations represent a higher BSE risk. Indicators for the sub-population of healthy slaughtered animals are of a lesser priority as often animals from one county are slaughtered in another county and, in consequence, the total national indicator would be met anyway. A designated official of GDAHW regularly monitors the collection of samples and progress made in meeting the indicators.

37. In one of the three counties visited, the number of animals from sub-populations at risk sampled, both in 2017 and 2018, exceeded the expected indicators. In the two other counties, the number of sampled animals was below the statistical indicators (except in 2017, when one of these two counties sampled three more animals from the sub-population of fallen stock than foreseen by the indicator).

38. Slaughterhouses’ operators provide sampling equipment and disposables for the sampling and transport of samples. In all of the slaughterhouses visited by the audit team, the equipment and disposables were in place in sufficient amount.

39. The official veterinarians carry out sampling in slaughterhouses. The audit team witnessed sampling by these officials and noted that it was carried out properly with a high degree of expertise. The samples collected contained all relevant anatomic structures necessary for laboratory examination, were placed in individual sampling containers and were labelled in a way that ensured their traceability to the bovine animal sampled. The examination request accompanying the collected samples contained all the necessary data to link the animals sampled to their last location and the sample

12

container. The audit team noted that two sampling containers (both from the same slaughterhouse) were marked with a marker but the marker ink could easily be wiped out leaving the sample without a clear link to the examination request. The officials in charge took immediate corrective measure (application of labels) to avoid such a situation in the future.

40. The audit team analysed the documentation available in the laboratories and slaughterhouses visited and noted that:

a. The BSE samples from slaughterhouses usually arrive to the laboratory on the day of sampling.

b. The laboratory staff examine the samples on the day of sampling or the day after reception of the sample to the laboratory.

c. Laboratories communicate the examination results to the official veterinarians usually the day following the reception of samples. The official veterinarian passes the examination results to the slaughterhouses’ operators without delays.

41. Authorised veterinarians and private practice veterinarians collect the samples from the bovine animals slaughtered (both healthy and slaughtered in emergency) and/or dead on farms. In the majority of cases, the whole head is collected by veterinarians from the animals slaughtered for own consumption and those dead on farms. The veterinarians deliver the sampled material (heads) to the laboratories. The SNIRA records and holding registers seen by the audit team and the statements received from the operators and owners of commercial and backyard holdings, respectively, confirm that on-farm slaughter takes place.

42. On commercial and Type-A holdings, authorised veterinarians use the sampling equipment and disposables provided by the operators, while for sampling at backyard holdings they use their own. The audit team noted that authorised veterinarians and holding operators met had sufficient amount of sampling equipment and disposables.

43. The appendix to this report presents the available detailed data on BSE monitoring in sub-populations of healthy slaughtered animals; emergency slaughtered and animals found sick at ante-mortem inspection, dead animals (fallen stock) and BSE suspects. The data are summarised and assessed in sections 5.3.1 to 5.3.4.

5.3.1 BSE monitoring in sub-population of healthy slaughtered animals

44. Owners of backyard holdings visited stated that occasionally slaughter of bovine animals takes place at farm but mostly for own consumption and it concerns rather younger animals (see finding 20.c).

45. In one of the backyard holdings visited, on-farm slaughter had taken place some days prior to the visit. The veterinarian had not been present during slaughter and the owner did not notify the veterinarian about the slaughter. The owner stated that there was no need to call a veterinarian as the animal was below 30 months and in perfect health.

13

46. The analysis of the available data from GDFS, SNIRA and the Laboratory Information and Management System (LIMS) on the sub-population of bovine animals slaughtered as healthy and eligible for BSE testing shows that:

a. The number of bovines slaughtered in slaughterhouses reported by GDFS is lower than bovines notified to SNIRA (see Tables 1 and 2).

b. Almost all bovine animals sampled as healthy slaughtered originate from slaughterhouses, while the vast majority of these slaughtered outside slaughterhouses (at holdings) are not sampled (see Tables 2, 3 and 4).

c. The number of animals slaughtered outside slaughterhouses (at holdings) and not sampled continuously grows (see Tables 5, 6 and 7).

d. The number of animals sampled but not tested since 2016 has a declining trend and is rather marginal (0.04% in 2018) (see Table 7).

5.3.2 BSE monitoring in the sub-population of animals emergency slaughtered and found sick at ante mortem inspection

47. The operators and official veterinarians from the slaughterhouses visited stated that none, or very few, bovine animals in slaughterhouses are found sick at ante-mortem inspection or slaughtered in emergency. At the same time, the commercial holdings’ operators and owners of backyard holdings met stated that bovine animals with health problems are immediately sold to slaughterhouses for slaughter, to avoid emergency slaughter on farm. The audit team noted:

a. In one slaughterhouse visited, the ante-mortem inspection records indicated three bovine animals found sick in 2018 and no records of such animals in 2019 up to the date of the audit. The audit team noted that none of the animals recorded in 2018 had been reported as found sick at ante-mortem inspection by the slaughterhouse in the 2018 reports to GDFS. However, some animals had arrived with food chain information from the holding stating that they were sick (suffering, for example, from cachexia, uterine prolapse and broken limbs). These issues had not been reported as such in the ante-mortem inspection records.

b. Randomly selected movement documents from a visited commercial holding contained records demonstrating that the holding operator had sent for emergency slaughter bovine animals over 24 months old to a slaughterhouse visited earlier by the audit team. There were one bovine in January and three bovines in March of 2018, two in July and one in August of 2019. The holding operator stated that every month he sells one or two sick bovine animals for emergency slaughter to the slaughterhouse. The slaughterhouse ante-mortem inspection records did not report animals with health issues.

c. The cross-check on the identification numbers of bovine animals with health issues sold to slaughterhouses for emergency slaughter and testing results has shown that:

14

i. in one slaughterhouse, these bovine animals were included in the sub-population of healthy slaughtered animals. The animals were over 30 months old and thus were sampled for BSE and reported in this sub-population;

ii. in another slaughterhouse, bovine animals were also included in the sub-population of healthy slaughtered but, being less than 30 months old, were not sampled and tested for BSE.

48. The analysis of the available data on the sub-population of bovine animals found sick at ante-mortem inspection and emergency slaughtered and eligible for BSE testing shows that:

a. Beginning from 2017, there is a visible increase in the number of bovine animals from the sub-populations of animals emergency slaughtered and found sick at ante-mortem inspection reported by slaughterhouses and eligible for BSE testing (see Table 8).

b. There is almost no difference between the number of bovine animals sampled and tested for BSE from the sub-population of found sick at ante-mortem inspection (see Table 9) and from the sub-population of emergency slaughtered animals (see Table 10), demonstrating that if samples are collected these are tested.

c. The cumulative number of bovine animals sampled as found sick at ante-mortem inspection and emergency slaughtered (data from LIMS) compared with the same two groups reported (jointly) by GDFS as slaughtered in slaughterhouses, demonstrates that, in reality, some bovines from these two sub-populations must have been slaughtered and sampled at holdings. This observation was corroborated by data (provided by GDAHW) indicating the number of bovine animals slaughtered in emergency slaughter at farms and eligible for testing; these were 1,324 (2016), 1,490 (2017) and 1,395 (2018).

However, detailed analysis of the presented data, broken down per counties (see additional comments under Tables 9 and 10), and examples seen by the audit team show that:

d. In some counties, slaughterhouses’ operators do not report the number of animals from these two sub-populations; moreover, by assigning sick bovine animals to a sub-population of healthy slaughtered (with higher age limit for sampling), they partially exclude these animals from being tested for BSE. This is not compliant with the provisions of point 2.1 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001.

5.3.3 BSE monitoring in sub-population of dead animals (fallen stock)

49. The 2018 statistics for Member States indicates that the percentage of mortality in a sub-population of fallen bovines over 24 months versus the entire bovine population in a given Member State ranged from 0.6% to 1.40%. According to official data (from SNIRA) the mortality percentage of bovines eligible for BSE testing in 2018 was 0.18%

15

and was the highest in the last five years: 0.1% (2014), 0.1% (2015), 0.12% (2016), and 0.15% (2017).

50. The private practice veterinarians met at backyard and commercial holdings visited stated that whenever an owner of bovine animals informed them about a dead animal, they had come to collect a sample and delivered the samples to the laboratory. However, there were cases when these veterinarians received the notification too late to be able to collect samples. In such cases, veterinarians can only enter the information on the death in SNIRA.

51. The audit team analysed the laboratory files on samples collected from fallen bovine animals and noted that:

a. Samples from fallen animals were delivered for analysis a day or two after being collected.

b. The majority of samples rejected as being not eligible for testing, were due to:

i. complete autolysis or absence of an anatomic structure required for testing: 15 (2014), 31 (2015), 17 (2016) and 22 (2017);

ii. an animal being of age below 24 months: two (2014), two (2015), four (2016), five (2017) and 16 (2018); and

iii. a mismatch of the information presented with these in SNIRA resulting with the animal not being identifiable: one (2014), 17 (2016).

52. The analysis of the available data (from SNIRA and LIMS) on the sub-population of dead bovine animals eligible for BSE testing shows that:

a. The number of bovine animals eligible for testing and sampled steadily grows but is still lower than the number of animals reported resulting in, on average, 25% of reported animals not being sampled, and thus not tested. This is not compliant with provisions of point 3.1 of Part I of Chapter A of Annex III to Regulation (EC) No 999/2001 requiring testing all fallen bovine animals of age over 24 months (4).

b. There is a difference between the number of samples collected and the number of samples tested, which is mostly linked to the complete autolysis or otherwise bad quality of the samples. The difference, however, is rather low, approximately 0.5%, demonstrating efficient collecting and delivery of samples to laboratories by the veterinarians when they had been informed in a timely fashion.

(4) All bovine animals over 24 months of age which have died or been killed but which were not: a) killed for destruction pursuant to Commission Regulation (EC) No 716/96; b) killed in the framework of an epidemic, such as foot-and-mouth disease; and c) slaughtered for human consumption, shall be tested for BSE.

16

5.3.4 BSE monitoring in sub-population of BSE suspects

53. The table below presents data (from LIMS) on the number of bovine animals with symptoms of neurological disorders and/or behavioural changes (BSE-like symptoms):

Year 2014 2015 2016 2017 2018

Reported 76 54 71 100 40

Sampled 76 54 71 100 40

Tested 74 55 (5) 64 110 (5) 36

54. The audit team noted that:

a. Official, authorised and private practice veterinarians met were aware of the BSE-like symptoms and the rules to be followed in such a situation.

b. The NSVFSA instruction established for BSE suspects requires testing regardless of the animal is being suspected of having another disease (metabolic disorder, infectious disease, intoxication, etc.).

c. Laboratories received entire heads as a BSE sample and subsequently harvested and secured the entire brain for testing.

d. Cases of rabies (31) and listeriosis (15) represent the majority of diseases responsible for notification of BSE-suspects.

Points a) – c) above are compliant with the requirements of Article 12 of the Regulation (EC) No 999/2001.

5.3.5 Laboratory and testing arrangement

55. The NRL–TSE and 28 county BSE laboratories carry out BSE tests and are accredited to EN ISO/IEC 17025 for the BSE tests they use, in line with Article 12 of Regulation (EC) No 882/2004.

56. The laboratories use three types of rapid tests and these are Bio-Rad TeSeE, IDEXX HerdChek BSE-SCRAPIE and Prionics Check PrioSTRIP. All these tests are listed in point 4 of Chapter C of Annex X to Regulation (EC) No 999/2001 as suitable for BSE rapid diagnostic.

57. The NRL-TSE is the only laboratory carrying out confirmatory tests and these are the following: Bio-Rad TeSeE Western Blot, the immunohistochemical and histopathological examination. All these tests and methods are listed in point 3 and 4 of Chapter C of Annex X to Regulation (EC) No 999/2001 as suitable for BSE confirmatory diagnostic.

(5) The GDAHW official explained that a higher number of samples tested can result from: a) a situation where a sample has been collected in December of one calendar year and tested in January of the following year or, b) where for one sample more than one test has been carried out.

17

58. Both the NRL-TSE and the county BSE laboratories have in place effective arrangements ensuring sufficient amount of BSE tests. Usually the county laboratories purchase more tests than needed for a given period taking into account that the surplus would cover the period needed for the new tender to be completed.

59. In the BSE laboratories visited, the audit team examined BSE testing kits and reagents and noted that none was expired. Moreover, the laboratories received the tests in batches, following prognosis for the use, significantly mitigating the risk of expiration of the validity of these tests.

60. The laboratory staff received regular training and participated in comparative tests organised by the NRL-TSE. The audit team examined records of these tests and noted that all laboratories achieved satisfactory results. This is compliant with the requirements of Article 101 of Regulation (EU) 2017/625 of the European Parliament and of the Council.

61. The laboratory staff receiving BSE samples verified whether the content of accompanying documents matched the samples, cross-checked samples identification with data from SNIRA (whether animals sampled are eligible for testing and had been notified in the database as dead), and assessed the quantity (approximately 100g) and the quality (the presence of required anatomical structures) of the samples. If the information from the accompanying documents did not match with the data from SNIRA, the staff called the veterinarian who had collected the sample to investigate the reason for the mismatch. In all the laboratories visited, the audit team saw evidence of such verification activities and noted:

a. The staff verified the samples immediately and with a high degree of proficiency.

b. For verifications indicating mismatches, investigations were immediate and resolving the issue took from one to four hours.

c. Proofs of verification of each sample received earlier were immediately available.

d. The quality and quantity of samples, including those collected outside slaughterhouses, were suitable to carry out BSE testing.

62. The audit team analysed files of BSE samples received and tested and noted that:

a. The laboratory staff usually examined samples on the day they were received.

b. Tests results were recorded and dispatched within 24 to 48 hours – on the day of the test or early on the following day.

c. The documents and records in place ensured the link between the sample and the test results.

d. There were records of samples for which rapid tests were repeated if the first examination result was inconclusive.

The above findings (61 and 62) satisfy the requirements of Article 11(7) of Regulation (EC) No 882/2004, which requires that samples must be handled and labelled in such a way as to guarantee both their legal and analytical validity.

18

Conclusions on BSE monitoring system, laboratory network and testing arrangement

63. A proportion of bovine animals slaughtered as healthy and eligible for BSE testing remains not tested; these are mostly animals slaughtered at backyard holdings. Consequently, the data available cannot reliably demonstrate that testing in this sub-population has been effectively implemented.

64. While there is an improvement in sampling in the sub-populations of animals found sick at ante-mortem inspection and emergency slaughtered, the absence of records of bovine animals displaying health issues or requiring emergency slaughter is contributing to underrepresentation of the real number of such animals and leads to the exclusion of such animals from being tested. Consequently, the available data cannot reliably demonstrate that testing in this sub-population has been effectively implemented.

65. A visible improvement in the collection of samples from fallen bovine animals occurred since 2016; nonetheless, approximately 25% of fallen bovine animals officially reported in SNIRA remains untested. Consequently, available data cannot reliably demonstrate that testing in this sub-population has been effectively implemented.

66. The measures taken to ensure that BSE-suspects are sampled and tested as required are effective. The available data can demonstrate that monitoring in this sub-population has been effectively implemented within the last six years.

67. The procedures and laboratory practices in place ensure the quality and the integrity of samples for BSE testing.

68. The NRL-TSE and county BSE laboratories use the tests listed in Regulation (EC) No 999/2001 and the laboratory staff perform analyses with a high degree of proficiency. This provides guarantees for the reliability of test results.

5.4 PROHIBITION CONCERNING ANIMAL FEEDING – FEED BAN

69. The NSVFSA Presidential Order No 42/2005 introduced measures for the implementation of the total ban on processed animal protein (PAP) in feed destined for livestock. This order contains the prohibition on feeding ruminants with proteins derived from animals and is aligned with the requirements of Article 7(1) of Regulation (EC) No 999/2001.

70. The NSVFSA Presidential Order No 16/2010 implements the derogations to the provisions of Article 7(1) and (2) of Regulation (EC) No 999/2001 and point 2 of its Annex IV.

71. The NSVFSA Service Note 5203/2014 provides guidance on the applicable requirements to the chain of generation, transport, storage and production of PAP from non-ruminants intended for feeding of aquaculture animals, and the administrative

19

procedure regarding the special authorisation of feed business operators involved in generating PAP and feed containing PAP of non-ruminant origin.

72. The NSVFSA Service Note 5641/23.01 comprises instructions for control of cross-contamination and homogenisation of feed. In this note, the NSVFSA requested CSVFSDs to organise training for feed operators regarding the checks on cross-contamination and homogenisation.

73. The controls on implementation of the feed ban rules are part of general feed official controls in feed mills, holdings with own mixers producing for own livestock only, and on other animal holdings (without mixer).

74. The Animal Nutrition Department of the NSVFSA together with the NRL for feed draw up the Annual Feed Control Programme that includes aspects of the feed ban and the use of PAP in feed. A risk analysis determines the frequency and the number of inspections in a county. The analysis takes into account the following factors: a) the target species, b) the type of feed produced, c) production volume and d) the history of non-compliance (including RASFF notifications). The CSVFSDs allocate the annual number of controls/samples to be taken in the four quarters of the year and in different types and number of operators.

75. In the CSVFSDs visited, the audit team examined available feed official control files and noted that:

a. Officials followed the procedures for risk-based controls and sampling when targeting operators for controls (without prior warning), and the results of their implementation were available.

b. Samples collected by officials, and by operators within own-check programmes, were analysed in the accredited laboratories of the CSVFSDs with the use of the microscopic method defined in Commission Regulation (EU) No 51/2013.

c. Operators have the right to examine samples of their own-check programmes in private laboratories; these, however, must be accredited and are obliged to report non-compliant samples to the CSVFSD.

d. The samples taken (by both officials and operators) were analysed within a few days. The CSVFSDs representatives met stated that presence of PAP in feed for ruminants has not been detected in the last three years.

e. Depending on the scope of the controls, the officials met used several control checklists; these contained elements relevant for the verification of the implementation of feed ban rules.

This satisfies the general obligations for the organisation of official controls laid down in Article 3 of Regulation (EC) No 882/2004.

76. In the feed mills visited, the audit team noted that:

20

a. The approvals seen were correct, the approval numbers were in line with the EU legislation and reflected the types of feed produced. The production target animal species were listed in the pre-approval reports.

b. The documentation kept by the operators comprised procedures based on hazard analysis and critical control points principles, traceability registers (incoming and outgoing materials/products) and the results of operators' own-checks.

c. The premises and equipment were generally in good hygienic conditions except for the presence of birds and bird droppings in the storage facilities with exposed feed materials (no relevance for feed ban).

77. Operators and owners of the holdings visited were aware of the feed ban rules. They stated that in the current circumstances (non-intensive production, low market demand and only moderate prices for milk and live animals destined for slaughter), purchase of industrial feed containing proteins of animal origin (except milk replacers at commercial holdings) is too expensive in comparison with cheaper feed of plant origin often from own production (corn, barley and wheat) and from own grazing lands.

78. In one of the feed mills visited, the operator abandoned the use of PAP in production of feed. As a result, the last time the operator sampled the feed for the presence of PAP was in 2017, despite its own-check programme still requiring it. However, official samples had been taken regularly and all the results seen were compliant (no detection of PAP).

Conclusions on the prohibition concerning animal feeding – feed ban

79. The arrangement for controls on the implementation of the feed ban rules is in place and followed. Available evidence can support the competent authority’s statement that the feed ban has been effectively implemented for the last six consecutive years.

5.5 FOLLOW-UP OF RECOMMENDATIONS FROM PREVIOUS COMMISSION AUDIT

5.5.1 Audit report DG(SANCO)2011-8950 on BSE

80. Recommendation 2 of the audit report DG(SANCO)2011-8950 requested the competent authority to ensure that all eligible bovine animals slaughtered at farm level are subject to BSE monitoring, in line with the provisions laid down in Annex III (Chapter A, point 2.1 and point 2.2) to Regulation (EC) No 999/2001 (6). In response to this NSVFSA declared that:

a. A working group with representatives of the central level and the counties would develop a guide for bovine owners concerning the slaughtering for own consumption. Such slaughter would be allowed only in low capacity slaughterhouses.

(6) Follow-up on this recommendation covered also implementation of corrective measures to recommendation 2011-8950-3 requesting fallen bovine animals to be subject to BSE monitoring, in line with the provisions laid down in point 3 of Part I of Chapter A of Annex III (,) to Regulation (EC) No 999/2001.

21

b. The CSVFSDs would be obliged to cross-check cases of backyard slaughter for own consumption with the information in SNIRA and with data on tests conducted for the BSE surveillance.

81. The audit team noted that, with regards to this recommendation:

a. The NSVFSA has abandoned the idea of producing the guide. Slaughtering of bovine animals is allowed in slaughterhouses and at holdings; the latter can take place provided that the ante-mortem inspection is carried out by authorised veterinarians who would also deliver the entire bovine head to county laboratories.

b. In addition, NSVFSA instructed the CSVFSDs' officials on sanctions for animal keepers not following the rules for notification of on-farm slaughter which, in its ultimate form, would cause reduction or temporary loss of subsidies from the program of direct payments for agriculture.

c. On cross-checking the information available in SNIRA on identified animals from the sub-populations eligible for BSE testing and the mortality rate see findings 21, 22 and 29.

d. On the monitoring of eligible bovine animals slaughtered on-farm as healthy, in emergency and found sick at ante-mortem inspection see findings and conclusions in Section 5.3.

5.5.2 Audit report DG(SANCO)2011-8941 on ABP

82. Recommendation 2 of audit report DG(SANCO)/2011-8941 requested the competent authority to put in place adequate systems to ensure that ABP are collected and disposed of in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council, as requested by its Article 4(4) (7). In response to this recommendation, NSVFSA declared that a working group, consisting of representatives of competent authorities involved in ABP field, would analyse and propose the adoption of the necessary measures to ensure that ABP are collected and disposed of according to the provisions of Regulation (EC) No 1069/2009.

83. The NSVFSA stated that at county level – the County Councils, and at the level of the municipality of Bucharest – the General Council of the Municipality of Bucharest, are responsible for the organisation of collection and disposal of ABP from individual backyard holdings. The Councils are obliged to contract an authorised operator for the collection and the disposal of ABP including fallen animals of all species.

84. In September 2018, the only operator providing throughout the country a service for collection and disposal of ABP (all categories including fallen animals) got bankrupt and ceased its activity. Since then, and up to the date of the audit, there are no ABP processing plants in Romania authorised for collecting and processing ABP of Category

(7) Follow-up on this recommendation covered also implementation of corrective measures to recommendation 2011-8950-5 requesting SRM produced as a result of home slaughtering of bovine animals, to be collected, transported and disposed of in compliance with requirements set out in Article 8(1) and Annex V to Regulation (EC) 999/2001.

22

1 and fallen animals. This situation resulted in a serious disturbance in the disposal of ABP originating not only from the husbandry sector but also from other sectors, namely the meat production, processing sector and the retail. Table 13 (see Appendix) presents detailed situation as regards the establishments processing ABP in the country at the time of this audit (8).

85. The NSVFSA explained that the situation is partially under control as operators from the meat and the retail sectors are obliged to have a contract with an operator ensuring collection and disposal of ABP. As regards the husbandry sector, a similar requirement applies to all animal holdings except backyard ones. For these, the county municipalities are responsible for ensuring the arrangement for collection and disposal of fallen animals and ABP generated during on-farm slaughter.

86. The audit team met with the representatives of County Councils from three counties and noted the following:

a. In 2016, the County Councils took over from local municipalities the obligation for providing collection and disposal of dead animals from backyard holdings.

b. Since 2016, the County Councils have organised a number of public tenders to fulfil this obligation but all tenders have failed due to the lack of bidders or because the bidders requesting exorbitant prices for their services.

c. The County Councils are limited in their tenders by the legally binding ceiling of L900/tonne for disposal and €1km for transport. According to the competent authorities met, this price is way below the price required by bidders which ranges from L3,000 per tonne plus VAT (and transport L20-50/km plus VAT) to L6,720 per tonne (costs of disposal and transport combined, including VAT).

d. The County Councils estimated the annual quantity of dead animals from backyard holdings to be collected and disposed of; these estimations (each for different county) were the following:

i. from 3% to 5 % of the population of animals (all species) in the county (the tonnage not specified);

ii. 624 tonnes (the quantity based on records of the operator from previous years); and

iii. 80 tonnes (the quantity based on an estimation gathered from local municipalities).

The above illustrates that County Councils do not use an uniform method allowing to reliably estimate the quantity of ABP, including fallen animals, to be collected and disposed of (9).

(8) In its response to the draft report the competent authority noted that the NSVFSA list of approved and registered establishments (valid as of May 2020) contains 17 establishments processing Category 3 material and 3 establishments processing Category 2 material; no establishment was authorised for processing Category 1 material.

(9) In its response to the draft report the competent authority noted that for estimating the quantities of ABP, including fallen animals, the County Councils should use the CSVFSDs' reports containing such data.

23

e. The counties have authorised burial sites in various locations in case of epizootic emergencies. The County Councils stated that these sites were selected together with the environmental and local authorities, to avoid any threat to local waters and the environment and could be used for burying dead animals from backyard holdings. However, a permanent arrangement for the management of these sites, for example a map with all the locations, contact details allowing immediate access to the supervising staff and burying equipment, a system for recording information on the buried animals, etc. was not in place (10).

87. According to the information received during this audit, yearly mortality rate for bovine animals should range from 1% to 3% of the total number of animals while, so far, it oscillates around 0.59% (see finding 31). The table below shows data on the number of bovine animals (all ages) reported to SNIRA as slaughtered on-farm (for own consumption) and dead on-farm:

Year 2014 2015 2016 2017 2018

Slaughtered on-farm 27,418 38,758 41,069 31,677 34,417

Dead on-farm 5,594 8,293 10,682 12,711 11,748

The audit team noted that to reflect the real situation on ABP generated at holdings the calculation should take into account also animals of other species slaughtered and dead at these holdings. However, the County Councils do not have this information.

88. In two visited slaughterhouses the audit team noted that:

a. The operators visited either signed a contract with operators transporting and/or disposing ABP or had their own incinerator.

b. Operators providing disposal of ABP were entities incinerating municipal waste authorised either under the environmental legislation and/or the relevant ABP legislation.

c. The incinerator used by one of the slaughterhouses visited was authorised in accordance with the ABP legislation as a small capacity incinerator (up to 50kg/hour). The audit team analysed the records of the ABP quantities produced by the slaughterhouse, functioning parameters of the incinerator and records (manual) of the incinerator activity and concluded that these could not support the statement that all of the ABP produced in the slaughterhouse had been disposed of through this incinerator (11). The other slaughterhouse visited could demonstrate

(10) In its response to the draft report the competent authority noted that there is a list of authorisations issued (since September 2019) for disposal of ABP of Category 1 and 2 and fallen animals by burial or incineration, following the evolution of notifiable disease outbreaks. Each such authorisation stipulates: a) the location and unique identification code of the farm/holding from which the ABP and/or animal(s) origin, b) GPS coordinates of the place of disposal, and c) the chosen disposal method.

(11) In its response to the draft report the competent authority noted that the NSVFSA President Order No. 79/2019 (in force as of 1 September 2019) introduced a series of specific requirements for the functioning of incineration and co-incineration establishments. These, in particular, refer to the equipment, the way of recording and record keeping of incineration parameters and quantities of incinerated ABP. Operators

24

regular collection and dispatch of plausible amount of ABP to an approved incineration plant.

89. In the commercial holdings visited the audit team noted that:

a. After the bankruptcy of the ABP operator, operators of the holdings signed contracts with companies incinerating municipal waste. According to these contracts, the companies apply charges based on the weight of fallen animals collected and distance for collection; in one case also an additional charge of L500 per load was applied. The holdings visited were approximately 150km away from the incinerators and according to the holding owners, the total cost of collecting one dead adult cow (combined weight and transport) would equal to almost 50% of the price for a new cow. Both operators stated that there were no dead animals at holdings, explaining that all bovine animals with health issues are immediately, prior to their death, sold to slaughterhouses (see finding 47.b).

b. In one of these holdings, on average, there were two to three young animals dead each month; these were buried on the land belonging to the operator. This is not compliant with the requirements of Article 13 of Regulation (EC) No 1069/2009.

90. In one backyard holding visited, the audit team noted that the owners had no arrangement for the collection and the disposal of ABP. The ABP generated during on-farm slaughter were fed to the dogs and buried, whereas dead animals were usually buried on the land belonging to the owner. This is neither compliant with requirements of Article 8 and Annex V to Regulation (EC) No 999/2001, nor with the requirements of Article 12 of Regulation (EC) No 1069/2009.

Conclusions on follow-up of recommendations of previous Commission audits

91. Overall, despite of some progress made, and in the light of the findings from Sections 5.2 and 5.3, recommendation 2 of the audit report DG(SANCO)2011-8950 remains unaddressed.

92. Overall, the system of collection and disposal of ABP, including of the fallen bovine animals from backyard holdings, has deteriorated since the previous audit. Therefore, recommendation 2 of audit report DG(SANCO)/2011-8941 remains unaddressed.

6 OVERALL CONCLUSIONS

With regard to Romania's application for review of its BSE monitoring programme it is concluded that, despite some positive trends observed, there are yet no grounds to allow for

received 180 days of transitional period to comply with the requirements.

25

the frequency of testing to be relaxed.

On the implementation of corrective measures taken to address recommendations made in the previous audits, some progress in addressing the recommendations of the previous BSE audit has been made only recently (as of 2017), whilst the ABP collections system has significantly deteriorated, resulting in recommendations from both audits remaining unaddressed.

Whilst the bovine identification and registration system is in place and official controls on identification are carried out regularly, the system lacks effectiveness due to the underreporting of events, mostly from backyard holdings (keeping 90% of the bovine population), the absence of regular follow-up on non-compliances identified and the lack of analysis of the available data. In consequence, despite steadily increasing trends in the number of tested samples and some improvement in the functioning of the laboratory network, a certain proportion of eligible bovine animals remains not sampled and, consequently, not tested.

The only area covered by this audit, relevant for supporting Romania’s application and where official controls have been satisfactorily implemented for the last six years and are effective, concerns the feed ban.

The existing system for ABP controls, which lacks a sustainable mechanism for regular collection and disposal of ABP, is not able to ensure that the ABP (originating at backyard holdings as a result of home slaughter), including fallen animals, are effectively collected and disposed of. Moreover, the current situation raises serious doubts whether ABP from the meat and the retail sector are collected and disposed of as required. The official controls have been ineffective in verifying and enforcing operators' compliance with the relevant requirements in this regard.

7 CLOSING MEETING

A closing meeting was held on 27 September 2019 with the representatives of the NSVFSA. At this meeting, the audit team presented the main findings and preliminary conclusions of the audit. Representatives from the competent authorities did not indicate any major disagreement with these.

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 25 working days of receipt of this audit report.

No. Recommendation

1. To take all necessary measures to verify the operators’ compliance with the provisions of Regulation (EC) No 1760/2000, as required by Article 22 of the said

26

No. Recommendation

Regulation.

Recommendation based on conclusions: 32, 33 and 34.Associated findings: 19, 20, 22.c, 26, 27, 28, 29, 30.b and 31.

2. To ensure compliance with the requirements laid down in Article 6 of Regulation (EC) No 999/2001 concerning BSE monitoring of all eligible bovine animals from relevant sub-populations, and in accordance with Part I of Chapter A of Annex III to the said Regulation.

Recommendation based on conclusions: 63 to 65, and 91.Associated findings: 46.a, 46.b, 47, 48.d, 52.a, and 81.

3. To ensure that an adequate system is in place ensuring proper collection, identification, treatment and disposal of ABP in accordance with the requirements laid down in Articles 12, 13 and 14 of Regulation (EC) No 1069/2009.

Recommendation based on conclusion: 92Associated findings: 84 to 90

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

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6635

27

APPENDIX1. Sampling in sub-population of healthy slaughtered animals

Table 1 contains data collected by GDFS representing the number of healthy bovine animals slaughtered in slaughterhouses in age over 30 months old, thus eligible for BSE testing.

Table 1

Year 2014 2015 2016 2017 2018

Total 69,195 114,328 163,371 163,060 112,468

Table 2 shows data (from SNIRA) representing the number of bovine animals over 30 months old, slaughtered in slaughterhouses.

Table 2

Year 2014 2015 2016 2017 2018

In slaughterhouses 72,170 118,643 166,584 170,276 123,913

Table 3 shows data from the LIMS representing the number of bovine animals over 30 months old, sampled as healthy slaughtered.

Table 3

Year 2014 2015 2016 2017 2018

Sampled 73,232 122,450 169,873 170,077 123,593

Table 4 shows data (from SNIRA) representing the number of bovine animals over 30 months old, slaughtered both in slaughterhouses and outside slaughterhouses (at holdings).

Table 4

Year 2014 2015 2016 2017 2018

In slaughterhouses 72,170 118,643 166,584 170,276 123,913

Outside slaughterhouses 4,171 6,853 7,680 5,798 6,247

Total 76,341 125,496 174,264 176,074 130,160

28

Table 5 shows data (from SNIRA) representing the number of bovine animals over 30 months old, slaughtered outside slaughterhouses (at holdings).

Table 5

Year 2014 2015 2016 2017 2018

Outside slaughterhouses 4,171 6,853 7,680 5,798 6,247

Table 6 shows a comparison of data on the sub-population of healthy bovine animals over 30 months old notified as slaughtered in slaughterhouses and at farms (data form SNIRA) and these sampled for BSE (data from LIMS).

Table 6

Year 2014 2015 2016 2017 2018

Slaughtered 76,341 125,496 174,264 176,074 130,160

Sampled 73,232 122,450 169,873 170,077 123,593

Balance - 3,109 - 3,046 - 4,391 - 5,997 - 6,567

Table 7 shows data (from LIMS) on the sub-population of healthy bovine animals over 30 months old, sampled and tested.

Table 7

Year 2014 2015 2016 2017 2018

Sampled 73,232 122,450 169,873 170,077 123,593

Tested 73,172 122,379 169,772 169,985 123,539

Balance - 60 - 71 - 101 - 92 - 54

2. Sampling in the sub-population of animals emergency slaughtered and found sick at ante-mortem inspection

Table 8 shows data (from GDFS) on the combined number of bovine animals, aged over 24 months, reported by slaughterhouses as found sick at ante-mortem inspection and as emergency slaughtered.

Table 8

Year 2014 2015 2016 2017 2018

Total 922 919 745 2,777 2,865

29

While analysing the GDFS data, broken down per counties, the audit team noted that, out of 42 counties, there were 15 counties in the period from 2013 to 2018 from which the slaughterhouses’ operators regularly reported the absence of animals found sick at ante-mortem inspection and emergency slaughtered , in age below and over 24 months.

Table 9 shows data (from LIMS) on the number of bovine animals over 24 months old, from the sub-populations of animals emergency slaughtered and found sick at ante mortem inspection, sampled and tested for BSE.

Table 9

Year 2014 2015 2016 2017 2018

Sampled 18 16 174 2,877 3,050

Tested 18 16 174 2,873 3,042

Balance 0 0 0 - 4 - 8

The analysis of the LIMS data, broken down by the counties, shows that until 2016, out of 42 counties, there were between two to eight counties sampling the sub-population of bovine animals found sick at ante-mortem inspection for BSE. In 2016, half of the counties began sampling. In 2017, 32 counties were collecting samples, increasing also the amount of samples. Out of the 10 remaining counties (without any or with a very low number of samples collected), three have no slaughterhouses.

Table 10 shows data (from LIMS) on the number of bovine animals over 24 months old from the sub-population of emergency slaughtered, sampled and tested for BSE.

Table 10

Year 2014 2015 2016 2017 2018

Sampled 1,230 1,561 1,799 2,712 2,581

Tested 1,222 1,551 1,792 2,704 2,573

Balance - 8 - 10 - 7 - 8 - 8

The analysis of the LIMS data, broken down per counties, on bovine animals emergency slaughtered shows that until 2016 – out of 42 counties – every year there were at least eight counties not sampling animals from this sub-population. The situation improved significantly as of 2017 when all of the counties started collecting samples.

30

3. Sampling in sub-population of dead animals (fallen stock)

Table 11 shows comparison of the number of bovine animals in age over 24 months notified as fallen (data from SNIRA) and these sampled for BSE (data from LIMS).

Table 11

Year 2014 2015 2016 2017 2018

Notified 2,732 3,951 4,656 4,485 4,532

Sampled 1,995 2,502 3,138 3,579 3,380

Balance: - 737 - 1,449 - 1,518 - 906 - 1,152

% not sampled 27% 37% 33% 20% -25%

Table 12 shows comparison of the number of bovine animals in age over 24 months sampled and tested for BSE (data from LIMS).

Table 12

Year 2014 2015 2016 2017 2018

Sampled 1,995 2,502 3,138 3,579 3,380

Tested 1,977 2,469 3,113 3,552 3,364

Balance: - 18 - 33 - 25 - 27 - 16

% not tested 0,90% 1,32% 0,80% 0,75% 0,47%

4. ABP processing plants

Table 13 shows the number of establishments processing different categories of ABP in the country (data from the NVFSA list of approved or registered ABP plants and operators, valid as of 2 September 2019).

Table 13

Category SpeciesABP from own slaughterhouse

only

ABP from own slaughterhouse and third party

ABP from third party

Category 1 Poultry 0 0 0

Pigs 0 0 0

Non-ruminants 0 0 0

Ruminants 0 0 0

31

Category 2 Poultry 2 0 0

Pigs 0 1 0

Non-ruminants 0 0 0

Ruminants 0 0 0

Category 3 Poultry 6 1 0

Pigs 4 0 0

Non-ruminants 0 0 3*

Ruminants 0 0 0

* One of the three plants collects raw material for production of processed fat and oils, and another one of the plants belongs to the operator that bankrupted in 2018.

1

ANNEX 2 – SPECIFIC LEGAL REQUIREMENTS RELATED TO SPECIFIC PROVISIONS AND MEASURES

SPECIFIC CHAPTER

IN THE REPORT

SPECIFIC PROVISIONS AND MEASURES

APPLICABLE LEGISLATION– LEGAL REQUIREMENTS CORRESPONDING TO THE SPECIFIC PROVISIONS AND MEASURES (12)

REG. 882/2004 REG. 2017/625 REG. 1760/2000 REG. 999/2001 REG. 1069/2009 REG. 142/2011 REG. 154/2009

4.1 REVISION OF THE BSE MONITORING PROGRAMME

ART. 6(1B);POINT 7 OF SECTION I OF CHAPTER A OF ANNEX III

5.1 DESIGNATION OF COMPETENT AUTHORITIES

ART. 4

5.1 STAFF PERFORMING OFFICIAL CONTROLS

ART. 6 ART. 10

5.2 REQUIREMENTS ON OFFICIAL CONTROLS AND THE SYSTEM FOR ANIMAL IDENTIFICATION

ART. 3,ART. 4(A),ART. 5,ART. 6,ART. 7,ART. 22,

5.3 BSE MONITORING SYSTEM

ART. 6,ART. 12POINT 2. AND

POINT 3 OF PART I OF CHAPTER A TO ANNEX III

5.3 ACCREDITATION AND LABORATORY SYSTEM

ART. 12, ART. 101 ART. 19CHAPTER A TO ANNEX X

5.3 TESTS FOR BSE DIAGNOSTIC

ART. 6(1)POINT 3 AND POINT 4 OF CHAPTER C OF ANNEX X

(12) Legal acts quoted in this Annex are provided in Annex 1 and refer, where applicable, to the last amended version.

2

SPECIFIC CHAPTER

IN THE REPORT

SPECIFIC PROVISIONS AND MEASURES

APPLICABLE LEGISLATION– LEGAL REQUIREMENTS CORRESPONDING TO THE SPECIFIC PROVISIONS AND MEASURES (12)

5.3 LABORATORY PROTOCOL AND INTEGRITY OF BSE SAMPLES

ART. 11 POINT 1 OF CHAPTER C OF ANNEX X

5.4 FEED BAN RULES AND METHODS FOR ANALYSIS

ART. 7(1) AND ART. 7(2),POINT 2 OF ANNEX IV

ANNEX VI

5.4 RISK-BASED CONTROLS ART. 3

5.5 BSE MONITORING POINT 2.1 AND POINT 2.2 OF CHAPTER A OF ANNEX III

5.5 THE USE AND DISPOSAL OF ABP

ART. 4(4), ART. 12,ART. 13,ART. 14

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleReg. 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

Reg. 999/2001 OJ L 147, 31.5.2001, p. 1-40

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

Reg. 1069/2009 OJ L 300, 14.11.2009, p. 1-33

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)

Reg. 142/2011 OJ L 54, 26.2.2011, p. 1-254

Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive

Reg. 1760/2000 OJ L 204, 11.8.2000, p. 1-10

Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97

Dir. 64/432/EEC OJ 121, 29.7.1964, p. 1977-2012

Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

Reg. 152/2009 OJ L 54, 26.2.2009, p. 1-130

Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed

Reg. 2017/625 OJ L 95, 7.4.2017, p. 1–142

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)Text with EEA relevance.