Food safety

Better Training for Safer FoodInitiative

Soledad Collado

Ivan Ambrozic

Control of Scrapie in the European Union

Food safety

Topics Covered

• Monitoring and surveillance programmes for Classical scrapie

• Scrapie classification of holdings and countries, and the consequences of this scrapie status on intra-EU trade.

• Eradication of Classical and Atypical scrapie in small ruminants

• The use of breeding programmes for TSE in sheep and goats in the frame of scrapie eradication,

Food safety

Scrapie

A disease of small ruminants caused by a prion

A member of the TSE family

Now generally regarded as an animal health disease with little public health significance.

2 forms of Scrapie

Classical Scrapie (CS)

Atypical Scrapie (AS)

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Monitoring and surveillance programmesfor Classical scrapie

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SCRAPIE SURVEILLANCE

Passive surveillance compulsory reporting of

all suspected animals

Active surveillance Reg. 999/2001 (EC) with

defined targets

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Subpopulations•ovine and caprine animals slaughtered for human consumption

•ovine and caprine animals not slaughtered for human consumption i.e. animals which have died or been killed, but which were not slaughtered for human consumption nor killed in the framework of a disease eradication campaign

Age classesOnly animals older than 18 months are included in the surveillance of TSE in small ruminants.

TSE surveillance in small ruminants

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Evolution and current legal provisions

1. animals slaughtered for human consumption: The animals (sheep and goats)

must be randomly selected, avoiding to over-represent any group as regard

the origin, age, breed, production type or any other characteristic. At least 10,000 slaughtered sheep and 10,000 slaughtered goats must be annually tested in each

MS*. For MSs which have difficulties to collect sufficient numbers of healthy slaughtered ovine and caprine animals, they may replace a maximum

of 50% of their sample with died animals over 18 months of age, and a maximum of 10% of their sample with animals over 18 months of age killed in the framework of a disease eradication campaign

2. animals not slaughtered for human consumption: The animals have to be died

on farm or killed (fallen stock) but not killed in the framework of a disease eradication campaign or slaughtered for human consumption. The minimum

number of animals not slaughtered for human consumption to be annually tested for each MS is reported in the tables

3. animals in infected flocks: a random sample (min 68 and max 150 according

to flock size) of animals over 18 months of age to be killed must be tested in each infected flock

4. Animals in infected flocks (holdings under TSE intensified monitoring protocol): all ovine and caprine animals which are over the age of 18 months and slaughtered for human consumption and all ovine and caprine animals over the age of 18 months which have died or been killed on the holding shall be tested for the presence of TSE

Surveillance in small ruminants

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Evolution and current legal provisions

Sampling rules:

• The animals shall be over 18 months of age• Sample must be designed with a view to avoid over-

representation of any group as regard the origin, age, breed, production type or any other characteristic.

• Sampling shall be representative for each region and season. • Multiple sampling in the same flock shall be avoided, wherever

possible holdings with more than 100 animals and where TSE hasnever been detected shall be subjected to sampling in succesiveyears.

Surveillance in small ruminants

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Scrapie classification of holdings and countries (Scrapie status) and its consequences on

intra-EU trade

1. Rules for granting status regarding classicalscrapie

2. EU trade with ovine and caprine animals

3. EU trade with reproductive material of ovine and caprine animals

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1. Rules for granting status regarding classical scrapie

1.1. Member state (parts thereof) status with

negligible risk / National Control Programme for CS

1.2. Holding with negligible / controlled risk

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1. 1. Rules for granting Member State (or parts thereof) status negligible risk for classical scrapie

(i) importation or introduction of ovine and caprine animals/ their

semen and embryos potentially infected

(ii) extent of knowledge of the population structure and husbandry

practices of ovine and caprine animals;

(iii) feeding practices, including consumption of meat-and-bone

meal or greaves derived from ruminants;

(iv) importation of milk and milk products of ovine and caprine

animals origin intended for use in feeding of ovine and caprine

animals;…..

a) Risk assesment (appropriate measures for the relevant period of time to manage any risk identified; identify all potential factors for classical scrapie occurrence and their historic perspective

MS application to the Commission (Point 2, Section A, Chapter A of Annex VIII):

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(b)Testing ov+cap displaying clinical signs compatible with CS

(c) Annual tests of a sufficient number (95% confidence, prevalence>0,1%) of ov+cap >18m, representative of slaughtered, culled orfound dead on farm, and no case of classical scrapie has been reportedduring that period;

(d) Feed ban and effectively enforced

(e) Introductions from other MSs of ov,cap, semen, embryoscomplying conditions (NR or CS holding/NR MS, ov ARR/ARR comingfrom holdings with no restrictions)

(f) Introductions from Third Countries of ov, cap, semen andembryos complying conditions of imports (annex IX)

Additionally, for a period of at least 7 years:

1. 1. Rules for granting Member State (or parts thereof) status negligible risk for classical scrapie

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National control programme for classical scrapie (Point 3, Section A, Chapter A of Annex VIII)

MMSS with a Programme “with additional guarantees” for CS maysubmit to the COM (in order to it is recognised):

the distribution of classical scrapie in the MS,

the reasons for national control programme, taking into consideration the importance of the disease and the cost/benefit ratio,

the status categories defined for holdings and the standards which must be attained in each such category,

the test procedures to be used,

the national control programme monitoring procedures,

the action to be taken if, for any reason, a holding loses its status,

the measures to be taken if the results of checks carried out in accordance with the national control programme programme are positive,

(b) approval procedure

NSCP

Approved status: Austria, Sweden, Finland, Approved programme: Denmark , Slovenia

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1. 2. Rules for granting holding status negligible orcontrolled risk for classical scrapie

Conditions for holdings with negligible risk

Point 1.2., Section A, Chapter A of Annex VIII

Conditions for holdings with controlled risk

Point 1.3., Section A, Chapter A of Annex VIII

List of holdings with negligible or controlled risk for classical scrapie

Member Stated shall maintain a list of holdings of ovine and caprineanimals with a negligible risk and holdings with a controlled risk ofclassical scrapie.

HOW? National implementing rules!

NR holding

CR holding

At least: 7 years

At least: 3 years

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Conditions for holdings with status negligible (7y) or controlled (3y) risk for classical scrapie

(a) permanently identified and records are maintained (tracing back to

holding of birth);

(b) records of movements of ovine and caprine animals in and out of the

holding are maintained;

(c) only the following ovine and caprine animals may be introduced:

(i) ovine and caprine animals from holdings with a negligible risk /

controlled of classical scrapie;

(ii) ovine and caprine animals from holdings which have met the

conditions laid down in points (a) to (i) for a minimum of 7 years

(negligible) / 3 years (controlled) or for at least the same period of

time as the holding where they are to be introduced;

(iii) ovine animals of the ARR/ARR prion protein genotype.

(iv) „derogation“ for the time spent in semen collection centre (new

with amm. 2016/1396)

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(d) Regular checks by official veterinarian or a veterinarian authorisedfor that purpose by the competent authority, after 1 January 2014

(e)(f) Health status conditions:

no case of classical scrapie has been confirmed (7 years / 3 years);

From 1 January 2014, all ovine and caprine animals over 18 months of age thathave died or have been killed for reasons other than slaughter for humanconsumption shall be tested in a laboratory for classical scrapie in accordancewith the laboratory methods and protocols set out in Annex X, Chapter C, Part3, point 3.2. *

* Changed with the amm. 2016/1396…before obligatory for allslaughtered animals over 18 months for human consumption

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(g),(h) Conditions in reproduction (semen / ova / embrios):

- requirements for donor animals - coming from MS / holding with

the required status; or

- ova / embrios with at least one ARR allel;

- semen from rams ARR/ARR;

(i) ovine and caprine animals on the holding have no direct or indirectcontact, including shared grazing, with ovine and caprine animals fromholdings of a lower classical scrapie status;

Negligible risk poss: TSE – resistance level 1 + 7 years no classicalscrapie. ARR/ARR

Maintainance of the status NR/ CR: Compliance, confirmed by; Official controls

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2. EU trade with ovine and caprine animals

“Basic legislation”:

Council Regulation (EC) 21/2004 establishing a system for the identificationand registration of ovine and caprine animals and amending Regulation (EC) No1782/2003 and Directives 92/102/EEC and 64/432/EEC;

Council Directive 91/68/EEC on animal health conditions governing intra-Community trade in ovine and caprine animals;

Council Directive 90/425/EEC concerning veterinary and zootechnical checksapplicable in intra-Community trade in certain live animals and products with a viewto the completion of the internal market;

Additional animal health requirements i.e.,

classical scrapie – Annex VIII Regulation 999/2001

brucellosis, bluetongue, ….

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To sum up… Minimum requirements for trade

Identification (electronically)- Directive 21/2004;

Animal Health conditions (Directive 91/68):

- definitions for categories of animals (purpose in destination);

- ovine/caprine animals for slaughter

- ovine/caprine animals for breeding

- ovine/ caprine animals for fattening

- compulsory notifiable diseases/absence of

certain diseases/ statuses for trade;

- residency period;

- model veterinary certificates (Annex E);

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Categories of animals for intraEU trade–Directive 91/68, art. 2

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Additionnal animal health conditions:

Classical Scrapie rules for trade of ovine and caprine(Annex VIII Reg 999/2001 and ammendments)

Commision Regulation (EU) No 630/2013 ammends Annex VIII of 999/2001 Chapter A, Section A , point 4:

Status of MS/holding of destination + intended „use“ of animals;

Reflected in Veterinary certificates for trade in Annex E to Directive 91/68(TRACES)

Commission Regulation (EU) 2016/1396 – ammending Annex VIII of 999/2001 Chapter A, Section A , point 4:

Certain „relaxations“ for animals of rare breeds;

Certain „relaxations“ for animals for „ZOOs“;

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Movement of animals for slaughter:

(Annex VIII of 999/2001 Chapter A, Section A, point 4)

- NO specific requirements regarding scrapie

Veterinary certificate : Model 1 in Annex E to Directive 91/68 (TRACES)

Risk Status in

MS/holding of origin

Intended use of the

animal in destination

(Category)

Risk Status Of

MS/Holding in

destination

Considerations to take into account for ClassicalScrapie rules in EU trade of ovine and caprine:

NSCPNSCP

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Risk Status in

MS/holding of origin

Intended use of the

animal in destination

(Category)

Risk Status Of

MS/Holding in

destination

Considerations to take into account for ClassicalScrapie rules in EU trade of ovine and caprine:

NSCPNSCP

Movement of animals for fattening:

(Annex VIII of 999/2001 Chapter A, Sect A, point 4)

Requirements only in case animals are intended to MSs /parts withnegligible risk status/programme:

Animals come from holding with negligible risk status; or

Animals come from MS with negligible risk status, or

ARR / ARR sheep

Veterinary certificate : Model 2 in Annex E to Directive 91/68 (TRACES)

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Risk Status in

MS/holding of origin

Intended use of the

animal in destination

(Category)

Risk Status Of

MS/Holding in

destination

Considerations to take into account for ClassicalScrapie rules in EU trade of ovine and caprine:

NSCPNSCP

Movement of animals for breeding

(Annex VIII of 999/2001 Chapter A, Section A , point 4)

Requirements of animals if intended to MSs/parts withand without negligible risk status/programme:

Animals come from a holding with status (at least thesame or higher) or

Animals come from MS with negligible risk status, or

ARR / ARR sheep

Veterinary certificate : Model 3 in Annex E to Directive 91/68 (TRACES)

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„Relaxations“ for movement of animals for breeding

Derogation in Annex VIII of 999/2001 Chapter A, Section A , point4 (a) and (b) for:

c) ovine and caprine animals which are kept in and moved exclusively between approved bodies, institutes or centres as defined in Article 2(1)(c) of Directive 92/65/EEC;

d) ovine and caprine of „rare breeds“ following prior approval, under following conditions……

Veterinary certificates for trade – ammended with ImplementingCommission Decision (EU) 2016/2002 (OJ L308, 16 November 2016)

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„Relaxations“ for movement of animals for breeding -link to zootechnical legislation

d) ovine and caprine of „rare breeds“ following prior approval, under following conditions;

local breed in danger of being lost to farming (as in DelegatedRegulation 807/2014);

the animals are entered in a flock book in MS of origin and MS ofdestination;

Breed being in preservation programme;

The holding of origin not under restrictions;

Possible limitations for further movement of animals

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•Ovine and caprine animals froma Member State with a negligible risk status for classical scrapie

•Ovine animals of the ARR/ARR prion protein genotype and do not come from a holding underrestrictions

•Ovine or caprine animals fromholdings having status of a negligible risk of classical scrapie

Member States other than those with the negligible riskstatus or ASCP (all MS exceptAT, DK, FI, SV, SI)

Member States with the negligible riskstatus or ASCP (AT, DK, FI, SV, SI)

Animals for all intended usesother than immediate slaughter

Animals for breeding

Conditions for Intra-Union trade in ovine and caprine animals

NR holding

ARR/ARR

NSCP

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Ovine or caprine animals from

holdings having status of a controled

risk of classical scrapie

Member States other than those with the negligible risk status orASCP (all MS except AT, DK, FI,

SV, SI)

Be carefull with introduction of animals on the holdings having

status of a negligible risk

Member States with the negligible riskstatus or ASCP (AT, DK, FI, SV, SI)

Conditions for Intra-Union trade in ovine and caprine animals

CR holding

NSCP

NR holding

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3. EU trade of reproductive material of ovine and caprine animals

“Basic legislation”:

Council Directive 92/65/EEC laying down animal health requirements governingtrade in and imports into the Community of animals, semen, ova andembryos not subject to animal health requirements laid down in specificCommunity rules referred to in Annex A (I) to Directive 90/425/EEC ;

Commission Decision 2010/470/EU laying down model health certificates fortrade within the Union in semen, ova and embryos of animals of the equine, ovineand caprine species and in ova and embryos of animals of the porcine species (lastamm. regarding small ruminants with 2014/802);

Council Directive 90/425/EEC concerning veterinary and zootechnical checksapplicable in intra-Community trade in certain live animals and products with a viewto the completion of the internal market;

Additional animal health requirements i.e. bluetongue,classical scrapie…

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Requirements for trade of reproductive material

Health requirements (Directive 92/65)

- Requirements for donor animals;

- originate from approved collecting centres /

storage / teams;

Model veterinary certificate (Commission Decision 2010/470)- TRACES

- Model certificate for semen (Annex III, Part A);

- Model certificate for ova & embrios (Annex IV, Part A);

Classical scrapie conditions: Annex VIII of 999/2001 Chapter A, Section A, point 4.2

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Eradication of Classical and Atypical scrapie in small ruminants

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Eradication Legislation

• Regulation (EC) 999/2001 • Articles 12 & 13

• Regulation (EU) 630/2013 and Regulation (EU) 2016/1396 (last amendments)

• Annex VII

• National legislation transposing the EU Regulation

• Contingency Planning for TSE in small ruminants (Art 14)

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Eradication Measures

• Positive Scrapie cases are generally as a result of

• Clinical suspects on farm

• Clinical suspects at slaughterhouses

• Non negative rapid test results

• Slaughterhouse

• Fallen animal

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Scrapie Suspects

Article 12, Regulation 999/2001

Any animal suspected of being infected with Scrapie shall be either

• placed under an official movement restriction until the results of a clinical and epidemiological examination carried out by the competent authority are known, or killed for laboratory examination under official control

• If Scrapie is officially suspected in an ovine or caprine animal at a holding in a Member State, all other ovine and caprine animals at that holding shall be placed under an official movement restriction until the results are available

• …other holdings or only the holding of exposure shall be placed under official control depending on the epidemiological information available

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Scrapie Suspect MeasuresOn farm measures on suspicion of Scrapie:

• Epidemiological investigation at the holding where case is suspected,

• measures instituted at other holdings, where applicable

Movement restrictions:• Holding restricted; provisional ban on trade to and from the

holding until results are known or animal no longer regarded as a suspect

• reporting of and submission of all eligible fallen stock at holding to the competent authority for Scrapie sampling.

Milk and milk products derived from ovine and caprine animals at the holding placed under official control, and which have remained at the holding from the date of suspecting Scrapie and pending the confirmatory test results, shall only be used within that holding

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Scrapie Confirmatory Results

Confirmation - NO:

– all the restriction measures, which have been instituted, are cancelled

Confirmation - YES:

– implementing of measures in accordance with Article 13 of Regulation 999/2001/EC and Annex VII to that Regulation

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Measures after Scrapie confirmation

Legal basis: Article 13, point 1(a) and point 2.1. AnnexVII, Regulation (EC) No. 999/2001

– restriction measures remain in place pending the

implementation of measures refered in paragraph 1(b) and 1 (c)

– inspection at the holding, full epidemiological investigation including identifying all the animals at risk and possible origin of the disease)

– disposal of all body parts from the affected animal inaccordance with Animal by Products Regulation (excluding the materials required for the additional investigations) Regulation (EC) 1069/2009

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Eradication of classical Scrapie

• Regulation (EU) 630/2013

• Amendment to Regulation (EC) 999/2001

• Point 2.2.2. Chapter B, Annex VII

• Regulation (EU) 2016/1396

• Amendment to Regulation (EC) 999/2001

• Point 4. Chapter B, Annex VII

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Eradication of classical Scrapie

• Scrapie now mainly regulated from an animal health perspective, rather than a public health one

• Classical Scrapie (CS):

• genetic resistance to CS in sheep is well known

• can be obtained by ingesting contaminated feed (milk, colostrum)

• can spread between animals, most probably at parturition time through infected foetal fluids

• Atypical Scrapie (AS) shows little tendency for spreading, occurs sporadically, in individual animals and usually in older animals

• The eradication measures are different

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Eradication of classical Scrapie –genetic resistance in sheep

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Measures after confirmation of Scrapie

• identifying all animals at risk

– all other ovine and caprine animals on the holding

- other holdings if deemed necessary following epidemiological investigation

– parents and last progeny if a female animal

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Conditions applying to a classical Scrapie Holding

• Where BSE and atypical scrapie has been excluded

• Milk and milk products derived from animals on farm shall only be

• Fed to ruminant animals on that holding

• Milk and milk products on the holding traded within that MS shall only be used for the feeding of non –ruminant animals

• Where no ruminant animals are kept• The products are moved and labelled in accordance with the ABP Legislation• The commercial document accompanying consignments of such milk and

milk products and any packaging containing such consignments shall be clearly marked with the words: ‘shall not be fed to ruminants’.

• How long? … from the date of confirmation until the date of completition ofmeasures

There is no restriction to use for human consumption milk from flocks under scrapie eradication. Point 2.2.2.a) of chapter B of Annex VII only foresees restrictions for using such milk intended to be used as feed.

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Eradication measures for classical Scrapie

• 3 options available depending on conditions on the holding

• Option 1

• Full depopulation; Killing and complete destruction of all small ruminant animals on the holding.

• Option 2

• Limited depopulation; killing and complete destruction of susceptible animals; ovines only

• Option 3

• No depopulation

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NSP 1

3%NSP 2

20%

NSP 3

46%

NSP 4

8%

NSP 5

23%

NSP 1

NSP 2

NSP 3

NSP 4

NSP 5

Uradni veterinar zapre gospodarstvo

Eradication of clasical Scrapie

Immediate genotyping (derogation for 3 months -

lambing season)

Movement restrictions milk

Epiepidemiological inquiry

Confirmed TSE case

Eradication option for clasical Scrapie shall be chosen

Option 2: Genotyping and killing and destruction of susceptible animals only

Option 1– killing and complete destruction of all animals

Flock - sheep

New flock: sheep NSP1, NSP2

rams NSP1 (measures Point 3 Chapter

B Annex VII apply for 2 years

Immediate slauhgtering:

Immediate killing of ewes and rams NSP3, NSP 5

Killing and complete destruction (derogation slaugtering and testing of all animals older than 18 months)

Compensation

Slaughtering

Sheep NSP4

Non genotyped lambs less than 3 months

Flock - sheep

Sheep NSP3

Rams NSP2, NSP4

Possible dlay of killing and destruction – up to 3 year

izločitve do 5 rejnih let (mlečni trop – do 18 mesecev)

Low level of resistant animals in flock - derofgation

Flock - goats kids less than 3 months

Option 3– no mandatory killing and complete destruction of

animals

Flock - goats

Measures in accordance to point

2.2.2.(a) os regard to milk and

measures from point 4 Chapter B

Annex VII apply for two years after

the last Classical Scrapie case

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The use of breeding programmes for TSE in sheep and goats in the frame of scrapie eradication,

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Breeding Programmes

Genetic resistance in ovines (Annex VII, chapter C Regulation 999/2001)

• To increase the genetic resistance of ovines on the holding against classical scrapie

• Using ARR/ARR breeding rams should significantly reduce the incidence of Classical Scrapie

• To attain homozygous ARR allele status of all ovines on the holding (gold plate status)

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Breeding Programmes

Measures in infected ovine flocks regarding selection on genetic resistance.

Genotyping of all breeding animals in the flock

Immediate culling of all rams with non resistant genotypes and introduction of ARR/ARR rams in to the flock

Further genotyping of newborns and selection – only animals with resistant (ARR/ARR) or semi-resistant genotype may stay in the flock

Food safety

Genetic resistance in goats (EFSA opinion 2017*):

Concluded that using genotypes that the K222, D146 and S146 alleles both confer genetic resistance against classical scrapie strains known to occur naturally in the EU goat population

Breeding Programmes

* Genetic resistance to transmissible spongiform encephalopathies (TSE) in goatsArticle (PDF Available) in EFSA Journal 15(8) · August 2017DOI: 10.2903/j.efsa.2017.4962

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Take Home Messages

There are 2 types of surveillance for TSEs and the targets to be met are specified in Annex 3 of the regulation and are in operation since 2002.

Based on scientific opinion there are now 3 options in relation to the eradication of Scrapie in small ruminants ranging from complete destruction of the herd/flock to maintaining all animals in the flock/herd. A derogation is included where animals in an infected flock/herd can be used for human consumption provided they have been subjected to the TSE test and give a negative result.

Atypical scrapie is not contagious, consequently eradication measures have in this case been replaced by monitoring.

Breeding programmes in ovines, when implemented, contribute immensely to the control and eradication of classical scrapie and increase the resistance of the national flocks.

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• Thank you for your attention

Food safety

Better Training for Safer Food

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