ALTERNATIVE ABP PROCESSES AND

Transcription

1 ALTERNATIVE ABP PROCESSES AND TSE/BSE E. VANOPDENBOSCH, F. BARIZZONE BIOLOGICAL HAZARDS (BIOHAZ) - EFSA

2 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

3 ALTERNATIVE ABP PROCESSES What EFSA does

4 Risk assessment Risk management Risk communication

5 What EFSA does Risk assessment Risk management Risk communication EC

6 What EFSA does EFSA is not responsible for legislation Risk assessment Risk management Risk communication EC

7 How EFSA scientific opinions are issued (from question to answer )

8 European Commission European Parliament Question? Member States EFSA ( self mandate ) Risk Assessment

9 Mandate Appropriate Panel Working Group Opinion adopted Draft Opinion

10 European Commission European Parliament Question? Member States EFSA ( self mandate ) Opinion Risk Assessment Media Industry Professionals Risk Communication Risk Management

11 ALTERNATIVE ABP Legislation in force (Reg. (EC) No 1069/2009)

12 Art. 20 Reg. (EC) 1069/2009: authorisation of alternative methods. Interested party send application to MS Competent Authority MS Competent Authority assesses application Compliance with standard format* Forward application to EFSA together with a report EFSA assesses application * 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 byproducts.

13 ALTERNATIVE Responsibility to demonstrate safety of an alternative method

14 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 ).

15 EFSA evaluation scheme

16 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. The framework consist of 7 steps.

17 1 st 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.

18 2 nd 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.

19 3 rd 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.

20 4 th 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). An alternative method should be equivalent to Method 1.

21 4 th step: Level of risk reduction 2/8 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 (output = end-product and every by-product of the process)

22 4 th step: Level of risk reduction 3/8 Why is important to measure input - output? 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

23 4 th step: Level of risk reduction 4/8 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 byproduct of the process). 4. Draw conclusions: method effective or not.

24 EFSA 4 th step: Level of risk reduction 5/8 known load Unchanged/increased load

25 4 th step: Level of risk reduction 6/8 Example: biogas and compost treatment for Cat 3 (Annex V Reg. (EU) No 142/2011) known load decreased load / absence 5 log 10 reduction of E. faecalis or S. Senftenberg 775W H 2 S- 3 log 10 reduction of thermo resistant viruses (eg: parvoviruses, circoviruses) 3 log 10 reduction of parasites at viable stages (eg: eggs of Ascaris sp.)

26 4 th step: Level of risk reduction 7/8 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.

27 4 th step: Level of risk reduction 8/8 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.

28 5 th 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.

29 6 th 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 of the end-products and by-products of the disposal process etc.

30 7 th 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).

31 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).

32 Major problems encountered so far when dealing with ABP applications

33 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 matching the ones reached in the experimental validation

34 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.

35 In summary (most important info to bring home)

36 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; to pay attention to input-output measures.

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

38 ASSESSMENT OF ABP IN THE FRAME OF TSE/BSE: EU legislation on SRM removal and feed ban DR. EMMANUEL VANOPDENBOSCH

39 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? PRION VIRUS

40 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 (PrP c ) into an abnormal protein (PrP res ) 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 contaminant

41 Pathogenesis studies serve as the basis for the definition of SRM Tissue Infectivity density (ColD 50 /g) Weight (kg) per 537 kg animal Cattle oral ID50 per BSE Case % of total infective load per animal Cumulative load Brain % 64.1 % Spinal cord % 89.7 % Trigeminal % 92.3 % ganglia Dorsal root % 96.1 % ganglia Ileum 3.20 E % 99.4 % Spleen* 3.20 E % 99.7 % Eyes 3.20 E % %

42 Main protective measures Specific risk materials (SRM) removal Feed ban

43 Legal Framework SRM: Article 8 and Annex V to Regulation (EC) Nº 999/2001 Feed ban: Article 7 and Annex IV to Regulation (EC) Nº 999/2001

44 SRM removal

45 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

46 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 animal infected by BSE

47 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) Dorsal Root Ganglia

48 Current SRM list Bovines (2) Animals >12 months: Skull (excluding mandible) Brain Eyes Spinal cord

49 Current SRM list Bovines (3) Animals all ages: Tonsils Intestines (from the duodenum to the rectum) Mesentery

50 Source:

51 Current SRM list Small ruminants (1) Animals >12 months: Skull Brain Eyes Spinal cord

52 Current SRM list Small ruminants (2) Animals all ages: Spleen Ileum

53 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 public health from the risk posed by BSE

54 Removal of SRM SRM shall be removed at: Slaughterhouses, or, as appropriate, other places of slaughter Cutting plants or authorised butcher s shops in the case of vertebral column

55 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) Ban on certain slaughtering techniques (pithing)

56 Additional measures to avoid cross-contamination (2): 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 bones

57 Additional measures to avoid cross-contamination (3): 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 system tissue

58 Disposal of SRM All SRM: Shall be stained or marked immediately on removal Shall be disposed of by incineration

59 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: no specific import requirements

60 Feed ban

61 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 being recycled in the feed chain

62 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 nonruminants (pigs, poultry, fish) in feed

63 2000 Year of birth of BSE cases detected in Member States Ruminant feed ban <

64 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 intended for ruminants

65 Total feed ban since January 2001 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)

66 Total feed ban since January 2001 Zero tolerance: any detected presence of prohibited constituents = infringement Exception: environmental contamination of feed materials of plant origin with insignificant amount of bones spicules

67 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

68 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

69 Pet food Not in the scope of the feed ban Manufacture prohibited in establishments producing feed intended for farmed animals Dedicated transport

70 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

71 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)

72 Possible evolution of the feed ban Lifting feed ban provisions for nonruminants (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

73 Conclusion Double barrier: SRM + feed ban Very strict conditions within the feed ban itself Extensive and strict controls

74 THANK YOU FOR YOUR ATTENTION

75 Time for discussion