ALTERNATIVE ABP PROCESSES AND

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Health and

A

LTERNATIVE

ABP

PROCESSES

AND

TSE

/

BSE

E. VANOPDENBOSCH, F. BARIZZONE

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Health and Consumers

Outline

• What EFSA does

• How EFSA Scientific Opinions are issued • Legislation in force

• Responsibility to demonstrate safety • EFSA evaluation scheme

• Major problems encountered so far • Most important things to bring home

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Health and

What EFSA does

ALTERNATIVE ABP PROCESSES

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Risk management Risk assessment

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Health and

Risk management Risk assessment

Risk communication

EC

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Health and Consumers Risk management Risk assessment Risk communication EC

What EFSA does

EFSA is not responsible for legislation

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Health and

How EFSA scientific

opinions are issued

(from “question” to “answer”)

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European Commission

European Parliament

Member States

EFSA (“self mandate”)

Question?

Risk Assessment

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Health and

Mandate

Appropriate Panel

_{Working Group}

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European Commission

European Parliament

Member States

EFSA (“self mandate”)

Question? Risk Assessment Opinion Risk Management Risk Communication Industry Media Consumers Professionals

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Health and

Legislation in force

(Reg. (EC) No 1069/2009)

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Art. 20 Reg. (EC) 1069/2009: authorisation of alternative methods.

EFSA assesses application

MS Competent Authority assesses application

Compliance with standard

format* Forward application to EFSA together with a report

Interested party send application to MS Competent Authority

* Standard format for application for alternative methods: defined by art. 16 of Reg. (EU) 142/2011 and reported in its Annex VII. The

latter has been amended by Reg. (EU) 749/2011.

It follows main points reported by EFSA Statement on the format for applications for new alternative methods for animal

by-products.

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Health and

Responsibility to

demonstrate safety of an

alternative method

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Responsibility to

• The application received by EFSA are dossiers to be assessed.

• It is the duty of the applicant to demonstrate the safety of a

specific process.

• EFSA evaluates only defined treatment processes not general

principles:

 All the specifications of the technical parameters

necessary for the proposed method need to be defined (e.g. time, temperature, particle size, technical

specification of the devices used, properties of the substrate, experimental validation using appropriate microbiological indicators, etc…).

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Health and

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Introduction

• When assessing a dossier EFSA follows the

framework reported by the EFSA Statement on the format for applications for new

alternative methods for animal by-products.

http://www.efsa.europa.eu/en/efsajournal/pub/1680.htm

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1st_step:_{Full description of the process}

• The rationale behind the process shall be described in detail:

• Material flow (including by-products such as waste water, gaseous emissions…).

• Critical parameters for the inactivation of the

pathogens (e.g. temperature, pressure, exposure time, pH, particle size…).

• Technical data sheet of the equipment used are provided.

• HACCP protocol and flow diagram presented.

• When relevant, microbiological criteria laid down in legislation are presented.

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2nd_step:_{Full description of material to be treated}

• The application should describe:

• Categories and subcategories of the ABP processed according to Art. 8, 9 and 10 of ABP Reg.

• Physical status of the material to be processed (e.g. water content, particle size…).

• If relevant, the pre-treatment process that has been applied.

• If relevant, materials other than ABP used and their impact on the level of risk reduction.

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Health and

3rd_step:_{Hazard identification}

• The relevant biological hazards for human/animal health should be identified. They should be related to the category and

subcategory of the material to be processed.

• The most difficult biological hazards to be inactivated by the

critical parameters identified under step 1 should be retained as primary target to demonstrate the risk reduction.

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4th_step:_{Level of risk reduction}_1/8

• The new process should be able to reduce the risk associated with the material to be processed to an acceptable level.

• The level of risk reduction should be at least equivalent to that achieved by methods already approved by ABP Regulation for the specific ABP material processed and final use of the end product obtained by the alternative method.

• E.g. dead pigs used to produce organic fertiliser, standard

method approved: Method 1 (133°C, 20 min., 3 bars, 50 mm particle size).

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Health and

Demonstrating the risk reduction is a critical point:

How to measure that

• In general on the basis of a validation experiment, it measures the reduction of:

– viability/infectivity of a known quantity of endogenous indicator organisms

– viability/infectivity of a test organism introduced into the starting material

• Essential to measure input – output material

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• The absence of pathogenic agents in the final material can be the result of:

– absence hazard / indicator in the starting material

– presence at low concentration in the starting material

?

unknown no pathogenic

agents Why is important to measure input - output?

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What shall be done: 1. Choose a suitable indicator:

• endogenous indicator or test organism

• present / added in the starting material

• easy to detect / quantify (important the analytical method)

• resistance characteristics similar to the pathogenic agents relevant for the ABP to be processed.

2. Quantify the agent in the starting material.

3. Quantify the agent in the final material (and in every by-product of the process).

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EFSA

known load Unchanged/increased

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known load decreased load /

absence

• 5 log₁₀ reduction of E. faecalis or S. Senftenberg 775W H₂S-

• 3 log₁₀ reduction of thermo resistant viruses

(eg: parvoviruses, circoviruses)

• 3 log₁₀ reduction of parasites at viable stages (eg: eggs of Ascaris sp.)

Example: biogas and compost treatment for Cat 3 (Annex V Reg. (EU) No 142/2011)

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The results have to be accompanied by evidences, e.g.:

• methodology used for the measures;

• n°of samples and evidence of their representativeness

(e.g. selection of measuring points);

• sensitivity/specificity of detection methods;

• data on repeatability and statistical variability of measures; etc…

If several treatment steps are involved it should be

assessed if early steps in the process may compromise the efficacy of the subsequent steps.

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Health and

In case a validation experiment is not feasible modelling or comparison with other processes may be acceptable if: 1. factors leading to the risk reduction are well known; 2. model of risk reduction is well established; and

3. continuous direct measurements of the factors leading to risk reduction are provided for the full scale process and these measures demonstrate that the factors are homogeneously applied throughout the treated batch.

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5th_step:_{HACCP plan}

The HACCP plan should:

• be based on the critical parameters for the risk reduction as reported under step 1;

• define the critical limits to be retained considering the results of the experimental validation/model;

• if relevant, include the technical limits to be met by the technical equipment used (e.g. feed screw revolutions, dosage of chemicals…);

• provide information on the parameters that have to be monitored and recorded;

• reflect normal and abnormal/emergency operating conditions and specify the corrective actions to be applied.

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Health and

6th_step:_{Interdependent processes}

• The dossier shall identify and evaluate possible

indirect impacts which may influence the level of risk reduction of the process.

• Indirect impacts may arise from:

– transport

– storage

– disposal

– etc.

of the end-products and by-products of the

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7th_step:_{Risk associated with end use}

• The dossier should specify the intended end-use

of products generated by the process.

• The risk for human/animal health and the

environment should be assessed on the basis of the risk reduction estimated under step 4 (Level of risk reduction).

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Final remarks

• Besides the application dossier, EFSA needs a documentary report drafted by the MS Competent Authority.

Not a simple forwarding of the application received by the MS but a short report complying with the EFSA evaluation

framework.

This helps the MS in performing a first scrutiny of the application dossier and helps EFSA in a better and quicker understanding of the submitted dossier.

• During the assessment of the process EFSA can ask for further information to the Applicant (including carrying out further tests).

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Major problems encountered

so far when dealing with

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• Language

• Lack of documentary report

• Framework not followed

• Hazard identification incomplete

• Input material not measured

• Agent against which experimental validation was

performed not relevant for the material to be processed.

• Extrapolation of data from experiments applying different conditions

• Process parameters in the dossier not specified or not consistent

• CCP for the routine monitoring of the new process not

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In case of negative opinion

• An alternative method can be considered as not valid by EFSA

when:

• there is no scientific basis

• the parameters reached do not guarantee the safety • some information is lacking.

• In the last two cases, it can be presented again after

improvement of the method or integration with the further information that may be required for the assessment.

• Thus, a negative outcome from an EFSA opinion does not

automatically imply that the proposed method will never be accepted.

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Health and

In summary…

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Remember:

• the level of safety that has to be demonstrated;

• what EFSA assesses and who has the responsibility to demonstrate the safety of a process;

• to check the dossiers according to the framework previously discussed;

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Health and

In case of problems an informal contact with the EFSA secretariat may be useful.

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ASSESSMENT OF ABP IN THE

FRAME OF TSE/BSE:

EU legislation on SRM removal

and feed ban

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Health and

What is BSE

Transmissible Spongiform Encephalopathy

Bovine Spongiform Encephalopathy, Scrapie,

Chronic Wasting Disease, Creutzfeldt Jakob Disease, etc…

“Spongiform” degenerative lesions in the brain,

FATAL

Long incubation

period

BACTERIA Protein? VIRUS PRION

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BSE, is part of a group of transmissible brain affections, characterised by:

Usually, “spongiform” degeneration of neuronal cells. Occurrence in man and animal

Usually, a fatal outcome Long incubation period

No apparent immune reaction.

Characterised by the transformation of normal brain protein (PrPc_{) into}

an abnormal protein (PrPres_{) or prion which is routinely used as a}

marker for infectivity.

Prion usually resistant to (at a variable degree…):

Heat / Ultraviolet light and ionising radiation Enzymes

Chemical substances

The TSE Agent behaves both like a

microbiological and a chemical

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Health and

Pathogenesis studies serve as the basis for the definition of SRM

Tissue Infectivity density (ColD₅₀/g) Weight (kg) per 537 kg animal

Cattle oral ID50 per BSE Case

% of total infective load per animal Cumulative load Brain ₁₀ _0.5 ₅₀₀₀ _{64.1 %} _{64.1 %} Spinal cord ₁₀ _0.2 ₂₀₀₀ _{25.6 %} _{89.7 %} Trigeminal ganglia 10 0.02 200 2.6 % 92.3 % Dorsal root ganglia 10 0.03 300 3.8 % 96.1 % Ileum _{3.20 E-02} _0.8 ₂₆ _{0.3 %} _{99.4 %} Spleen* _{3.20 E-02} _0.8 ₂₆ _{0.3 %} _{99.7 %} Eyes _{3.20 E-02} _0.1 ₃ _{0.04 %} _{99.74 %}

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Main protective measures

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Specific risk materials (SRM) removal

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Health and

Legal Framework

SRM

:

Article 8 and Annex V to

Regulation (EC) Nº 999/2001

Feed ban:

Article 7 and Annex IV to

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What are SRM ?

 Specified risk materials (SRM) are defined

as the animal tissues being most at risk of harbouring the BSE agent in an animal

affected by BSE and which can

consequently pose a risk to human health if consumed

 SRM removal = most important measure in

terms of protection of public health against BSE

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Identification of SRM

 Scientific advices (Scientific Steering

Committee of the European Commission, European Food Safety Authority)

 Pathogenicity studies aiming to

determine the amount and distribution of infection in the different tissues of an

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Health and

Current SRM list – Bovines (1)

Animals >30 months:



Vertebral

Column

(excluding the vertebrae

of the tail, spinous and transverse processes

of the cervical, thoracic and lumbar

vertebrae and the median sacral crest and

the wings of sacrum)

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Current SRM list – Bovines (2)

Animals >12 months:



Skull

(excluding mandible)



Brain



Eyes

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Health and

Current SRM list – Bovines (3)

Animals all ages:  Tonsils

 Intestines (from the duodenum to the

rectum)

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Health and

Current SRM list – Small ruminants (1)

Animals >12 months:



Skull



Brain

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Eyes

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Current SRM list – Small ruminants (2)

Animals all ages:



Spleen

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Health and

Removal of SRM

 SRM must be removed from the food and

feed chains to avoid the risk of transmission and recycling of the BSE agent

 The most important measure to protect

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Removal of SRM

SRM shall be removed at:

 Slaughterhouses, or, as appropriate, other

places of slaughter

 Cutting plants or authorised butcher’s

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Health and

Additional measures to avoid cross-contamination (1):

 Ban on the use of bones of bovine, ovine and

caprine animals for the production of mechanically separated meat (MSM)

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 Specific requirements

for the harvest of

tongues: transverse cut rostral to the

lingual process of basihyoid bone

Tongue bones

Transverse cut rostral to the tongue

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Health and

 Specific requirements for the harvest

of head meat: dedicated areas, heads properly sealed (foramen magnum

and frontal shot hole), sampling for the detection of central nervous

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Health and Consumers Disposal of SRM All SRM:  Shall be stained or marked immediately on removal  Shall be disposed of by incineration

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Health and

Trade rules as regards SRM

 SRM cannot be exported (EU SRM list more

stringent than OIE list)

 Import requirements related to the removal of

specified risk material linked to the OIE BSE risk status of the country

 For countries with OIE negligible BSE risk status:

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Health and

Why a feed ban?

 Processed animal proteins (PAPs)

contaminated by BSE prion are known to be a transmission route for BSE

 A feed ban prevents the BSE prion from

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History of the feed ban in EU

 1994: Ban on the use of proteins

derived from mammals for feeding ruminants

 1997: Pressure cooking system (133°,

20’, 3 bars) for processing mammalian waste into meat-and-bone meal (MBM)

 End 2000: Prohibition of the use of SRM

in the whole EU

 2001: Total (extended) feed ban

 2013: Reg 56/2013: PAPs from

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Health and 0 200 400 600 800 1000 1200 1400 1600 1800 2000 < 1990 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Year of birth of BSE cases detected in

Member States

Ruminant feed ban

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Total feed ban since January 2001

 Wide suspension on the use of PAP in feed

for farmed animals kept, fattened or bred for the production of food

 Purpose: prevention of cross-contamination

between feed containing PAP intended for species other than ruminants and feed

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Health and

 Extended to proteins of all animal origin  Species of origin very difficult to identify

because of the mandatory drastic heat treatment of mammalian proteins

(« pressure cooking »: 133°C/ 3 bars/20’/<50mm)

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•_{prohibited constituents = infringement} Zero tolerance: any detected presence of

• Exception: environmental contamination of feed materials of plant origin with

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Total feed ban since January 2001

Limited derogations to feed the following proteins to all farmed animals:

• egg and milk products

• gelatine from non ruminants (NR)

• hydrolysed proteins from NR

• hydrolysed proteins from ruminant hides and skins

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Total feed ban since January 2001

Other derogations to feed certain proteins under very strict conditions:

• To unweaned ruminants only: fishmeal

• To NR farmed animal: fishmeal, di and

tricalcium phosphate, blood products from NR, blood meal from NR to fish

• Strict channelling and labelling conditions with regard to delivery, production and

transport of (bulk) feed to avoid any

contamination of feed in which the protein is prohibited

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Health and

Pet food

• Not in the scope of the feed ban

• Manufacture prohibited in establishments producing feed intended for farmed animals

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Export of PAPs outside EU

• Prohibition to export PAPs from ruminants and products containing such proteins (only exception: pet food)

• Other PAPs except fishmeal:

• Export allowed if destined for uses not prohibited by the EU feed ban

• But written agreement needed between exporting and importing countries

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Controls of the feed ban

• Based on feed microscopy (Reg. (EC) N° 152/2009)

• Zero tolerance rule (LOD < 0.1 %)

• Over 50,000 samples per year in the EU

• Risk targeted controls

• A new diagnostic DNA-based method which is able to detect very low level of ruminant material that may be present in feed is EC validated. That method can be used for performing routine controls on

PAP and compound feed containing PAP in order to verify the absence of proteins of ruminant origin (Reg. (EC) N° 56/2013)

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Possible evolution of the feed ban

• Lifting feed ban provisions for

non-ruminants (pigs, poultry, fish) while avoiding cannibalism : Regulation 56/2013

Conditions: control tools available for species distinction (PCR methods) +

dedicated production lines

• Lifting feed ban provisions for ruminants is not envisaged

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Health and

Conclusion



Double barrier: SRM + feed ban



Very strict conditions within the feed ban

itself

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THANK YOU FOR YOUR ATTENTION

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Health and