Statement on technical assistance on the format for applications for new alternative methods for animal by-products 1

SCIENTIFIC OPINION Statement on technical assistance on the format for applications for new alternative methods for animal by-products 1 EFSA Panel on Biological Hazards (BIOHAZ) 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT EFSA s Scientific Panel on Biological Hazards (BIOHAZ) was asked for technical assistance in the development of a standard format for applications for new alternative methods of use and disposal for Animal By-Products (ABPs). Taking into account current informal non-binding guidelines jointly prepared by the European Commission and EFSA the BIOHAZ Panel prepared a proposed standard format. In comparison with the above mentioned guidelines, the proposed standard format i) further clarifies the information needed when submitting an application and ii) aligns the terminology used with that presented in the Principles and Guidelines for the Conduct of Microbiological Risk Assessment by the Codex Alimentarius Commission. A glossary of terms used, mainly derived from the above mentioned document, was proposed to be added as an appendix to the standard format. KEY WORDS Applications, Animal By-Products, alternative methods 1 On request from the European Commission, Question No EFSA-Q-2010-00072, adopted on 07 July 2010. 2 Panel members: Olivier Andreoletti, Herbert Budka, Sava Buncic, John D Collins, John Griffin, Tine Hald, Arie Hendrik Havelaar, James Hope, Günter Klein, James McLauchlin, Winy Messens, Christine Müller-Graf, Christophe Nguyen-The, Birgit Noerrung, Luisa Peixe, Miguel Prieto Maradona, Antonia Ricci, John Sofos, John Threlfall, Ivar Vågsholm, Emmanuel Vanopdenbosch. Correspondence: biohaz@efsa.europa.eu 3 Acknowledgement: the Panel wishes to thank the members of the Working Group on Request for technical assistance on the format for applications for new alternative methods for animal by-products for the preparatory work for this opinion: Reinhard Böhm, John Griffin, Christophe Nguyen-The, Zbigniew Paluszak, Robert Somerville. Suggested citation: ; Statement on technical assistance on the format for applications for new alternative methods for animal by-products.. [12 pp.]. doi:10.2903/j.efsa.2010.1680. Available online: www.efsa.europa.eu European Food Safety Authority, 2010 1

SUMMARY Following a request from the European Commission, the EFSA Scientific Panel on Biological Hazards (BIOHAZ) was asked to provide scientific advice on the format for applications for new alternative methods for Animal By-Products (ABPs). The revised ABP Regulation 4, which will enter into force in 2011, has introduced a formalised procedure for applications for new alternative methods of use and disposal for ABPs. This procedure builds upon the existing informal non-binding guidelines prepared jointly by DG-SANCO and EFSA 5. The Regulation foresees that a standard format for such applications shall be adopted by way of legislation under the responsibility of the Commission. The Commission services prepared a draft format reflecting the content of the current informal guidelines and asked EFSA for technical assistance with the development of a standard format. Considering the draft provided by the European Commission the BIOHAZ Panel prepared a proposed standard format. In comparison with the current joint DG-SANCO/EFSA non-binding guidelines 5, the proposed standard format i) further clarifies the information needed when submitting an application and ii) aligns the terminology used with that presented in the Principles and Guidelines for the Conduct of Microbiological Risk Assessment by the Codex Alimentarius Commission 6. A glossary of terms used, mainly derived from the above mentioned document, was proposed to be added as an appendix to the standard format. Additional comments were given by the BIOHAZ Panel in the context of the implementation of the revised ABP Regulation suggesting i) to define the requirements for the reduction of the representative pathogens or indicators according to the final use of the different ABP categories to be processed, with the different ABP categories representing different risks of microbiological contamination of the input material, ii) to use the term validation as defined in the glossary of the proposed standard format and as elaborated on in the EFSA 2005 opinion on the safety vis-à-vis biological risks of biogas and compost treatment standards of ABPs 7 and iii) not to use end product testing as a synonym for the term validation. 4 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). OJ L 300, 14.11.2009, p. 1 33. 5 Publicly available at the European Commission website (document n SANCO/2806/2008): http://ec.europa.eu/food/food/biosafety/animalbyproducts/disposal0604_rev_en.pdf 6 CAC (Codex Alimentarius Commission), 1999. Principles and Guidelines for the Conduct of Microbiological Risk Assessment. Available from: www.codexalimentarius.net/web/more_info.jsp?id_sta=357 7 EFSA (European Food Safety Authority), 2005. Opinion of the Scientific Panel on biological hazards (BIOHAZ) on the safety vis-à-vis biological risks of biogas and compost treatment standards of animal by-products (ABP). The EFSA Journal, 264, 1-21. 2

TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the European Commission... 4 Terms of reference as provided by the European Commission... 4 Introduction... 5 Proposed standard format... 5 1. Section I... 5 1.1. General provisions... 5 2. Section II... 5 2.1. Standard Format... 5 2.1.1. Chapter I... 5 2.1.2. Chapter II... 5 2.1.3. Glossary... 9 Documentation provided to EFSA... 10 References... 10 Appendix... 11 3

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION The revised Animal by-products Regulation (EC) No 1069/2009, which will enter into force in 2011, has introduced a formalised procedure for applications for new alternative methods of use and disposal for animal by-products. This procedure builds upon the existing informal non-binding guidelines, which have been drawn up in collaboration with EFSA (publicly available at the website of DG SANCO document SANCO/2806/2008). Under Article 20, paragraph 10, of Regulation (EC) No 1069/2009, a standard format for such applications shall be adopted by way of legislation under the responsibility of the Commission. The Commission services have prepared a draft format which reflects the content of the current informal guidelines. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION In accordance with Article 31 of Regulation (EC) No 178/2002, EFSA is asked for technical assistance with the development of a standard format and in particular, for any comments which may have on the proposed draft. 4

INTRODUCTION The BIOHAZ Panel has prepared a proposed standard format based on a draft previously prepared by the European Commission services (see Appendix). The BIOHAZ Panel did not comment on Section I and Section II, Chapter I of the draft provided by the European Commission services since these sections relate to procedural aspects only. In comparison to the current joint DG-SANCO/EFSA Guidelines for applications for new alternative methods of disposal or use of animal by-products (EC, 2008), the proposed standard format provided in the following sections aims i) to further clarify the information needed when submitting an application and ii) to align the terminology used with that presented in the Principles and Guidelines for the Conduct of Microbiological Risk Assessment by the Codex Alimentarius Commission (CAC, 1999). A glossary of terms used, mainly derived from the above mentioned document, is proposed to be added as an appendix to the standard format. The proposed standard format relates only to biological hazards within the remit of Regulation (EC) 1069/2009 8. PROPOSED STANDARD FORMAT 1. Section I 1.1. General provisions No comments were made to this section since it relates to procedural aspects only. 2. Section II 2.1. Standard Format 2.1.1. Chapter I No comments were made to this chapter since it relates to procedural aspects only. 2.1.2. Chapter II It is proposed that this chapter be amended as follows: 2.1.2.1. Content of applications 1. Only applications containing defined treatment processes can be assessed by EFSA. Applications containing only general principles of treatment will not be evaluated. 8 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). OJ L 300, 14.11.2009, p. 1 33. 5

2. Applications shall contain sufficient information on the following points, in order to allow EFSA to assess the safety of the proposed alternative methods. a. Full description of the process. The rationale behind the new process shall be described in detail. The material flow in the process shall be described including the by-products generated by the process itself (e.g. waste water, gaseous emissions). The parameters that are critical for the inactivation of the pathogens (e.g. temperature, pressure, exposure time, ph, particle size) shall be stated in relation to the process. Technical data sheets of the equipment used in the relevant process steps shall be provided. A formal HACCP protocol and a flow diagram showing each step in the process shall be part of the application presented. Information must be provided on the microbiological criteria, if any, laid down in the relevant legislation that will be measured for end-products and by-product generated by the process (e.g. like the ones fixed in Annex VI, Chapter 2, D. 15 of the ABP Regulation for digestion residues or compost) 9. b. Full description of the material to be treated. The categories and sub-categories of Animal By-Products (ABPs) which are supposed to be processed by the alternative method shall be described according to the categories referred to in Articles 8,9 and 10 of Regulation (EC) No 1069/2009. The physical status (e.g. water content, particle size) of the material and, if relevant, the pre-treatment process to which it has been submitted shall be described. If materials other than ABPs are to be used in the course of the process, these shall also be described. Their impact, if any, on the level of risk reduction due to their interaction with the ABPs, should be considered. c. Hazard identification. The relevant biological hazards for human and animal health should be identified. These should be related to the category and subcategory of the material to be processed. In the application the biological agent/s which are the most difficult to be inactivated by the critical parameters defined in the above mentioned point 2.a. ( Full description of the process ) should be retained as the primary target/s for demonstrating the risk reduction achieved by the process. d. Level of risk reduction In principle, the new proposed process should be able to reduce the amount of the most resistant biological hazards associated with the category of the material to be processed for a defined final use to an acceptable level. This principle will apply for example to prions for Cat. 1 ABPs, to bacterial spores for general Cat. 2 ABPs and also to pathogens relevant for Cat. 3 material as well as manure and digestive tract content. Taking into account the input material and the end use of the specific product obtained through the process, the level of risk reduction must be at least equivalent to that achieved by the methods and, when available, processing standards already approved under the Regulation (EC) 1069/2009. For instance, the standard already approved for validation of 9 The European Commission Service is invited to update this reference at the time of the entering in force of the revised ABP Regulation. 6

composting processes for Cat 3 ABPs 10 can be used as a benchmark for other treatment processes for comparable input material and potential end-use. The appropriate risk reduction should be achieved both in the end-product and in the byproducts (e.g. waste water) generated by the process. Generally the level of risk reduction for human and animal health which can be achieved by the process should be evaluated on the basis of direct measurements (validation). Some justified exceptions may be acceptable (see the end of this section). The validation of the intended process can be performed by measuring the reduction of viability/infectivity of: i) endogenous indicator organisms during the process, where the indicator is: or consistently present in the raw material in high numbers, not less resistant to the lethal aspects of the treatment process, but also not significantly more resistant than the pathogens for which it is being used to monitor, relatively easy to quantify and relatively easy to identify and to confirm; ii) a well-characterised test organism or virus introduced in a suitable test body into the starting material. Results should be accompanied by evidence. This includes, for measurements, information on the methodology used, nature of samples which have been analysed and evidence that samples are representative (e.g. number of samples, number of tests performed and selection of measuring points). If several treatment steps are involved, an assessment should be performed on the degree to which individual titre reduction steps are additive, or whether early steps in the process may compromise the efficacy of subsequent steps. In any case it is necessary to provide the sensitivity and specificity of the detection methods applied. Data on the repeatability and statistical variability of the measures obtained during the experiments should also be presented. If surrogates for prion measurement are used, an explanation should be given of their relevance. In case no direct measurement of the risk reduction is available (i.e. no validation as defined above is feasible) modelling or comparison with other processes may be acceptable if: i) the factors leading to the risk reduction are well known; ii) the model of risk reduction is well established; and iii) continuous direct measurements of the factors leading to the risk reduction are provided for the full scale process which demonstrate that these factors are homogeneously applied throughout the treated batch. 10 Reference should be made to the relevant part of the Annexes to the Reg. (EC) 1069/2009. 7

e. HACCP plan The HACCP plan shall be based on the critical parameters (e.g. temperature, pressure, time, microbiological threshold values) used to obtain the required risk reduction. The critical limits retained in the HACCP plan should be defined considering the results of the experimental validation and/or of the model provided. The successful functioning of the process may need some key technical parameters specifically related to the equipment used. Therefore, the HACCP plan must also include the technical limits to be met (e.g. energy uptake, feed screw revolutions, number of pump-strokes, dosage of chemicals). Information should be given on the critical and technical parameters that will be monitored (either continuously or intermittently) and recorded. Information should also be given about the methods used for measuring and monitoring these parameters. The variability of parameters under typical production conditions should be taken into account. The HACCP plan should reflect normal and abnormal/emergency operating conditions including a breakdown of the process and specify possible corrective actions to be applied. f. Risk associated with interdependent processes Possible indirect impacts which may influence the level of risk reduction of a particular process should be evaluated. Indirect impacts may arise from transport and storage of end-products and by-products as well as safe disposal of by-products generated by the process itself (e.g. waste water). g. Risk associated with the intended end use of the products The intended end use of all products generated by the process should be specified. The likely risks for human health, animal health and the environment should be assessed based on the risk reduction estimated in accordance with point d. 3. Applications shall be submitted with documentary evidence, the evidence indicated under point 2. as well as other evidence aiming to substantiate the explanation given under the framework set out under the above mentioned point 2. 4. Applications shall include a contact address for the interested party, which shall include indications of the name and full address, telephone and/or fax numbers and/or the electronic mail address of a particular contact person that is responsible as or on behalf of the in interested party. 8

2.1.3. Glossary Corrective action: any action to be taken when the results of monitoring at the CCP indicate a loss of control. Critical Control Point (CCP): a step at which control can be applied and is essential to prevent or eliminate a hazard or reduce it to an acceptable level. Critical limit: a criterion which separates acceptability from unacceptability. Flow diagram: a systematic representation of the sequence of steps or operations used in the treatment of a particular ABP, including all materials entering the process and all products and byproducts generated by the process itself. HACCP (Hazard Analysis and Critical Control Point): a system which identifies, evaluates, and controls hazards which may have significant health or environmental effects. Hazard Identification: the identification of biological agents capable of causing adverse health or environmental effects and which may be present in a particular category or sub-category of animal byproducts. Hazard: a biological agent in a particular category or sub-category of animal by-products with the potential to cause adverse health or environmental effects. Monitor: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control. Risk: a function of the probability of an adverse health or environmental effect and the severity of that effect, consequential to a hazard(s) in the end-products or by-products resulting from a process. Validation: an experimental approach in which representative test organisms or indicators are exposed to a treatment process under defined conditions in order to find out if the treatment is able to inactivate a certain group of pathogens with comparable survival patterns (tenacity) up to a point when the remaining risk of transmission is negligible. This is fulfilled if a defined reduction in a specific target parameter is obtained (e.g. 5 log 10 for Salmonella Senftenberg for composting Cat 3 material according to the ABP Regulation). 9

ADDITIONAL COMMENTS During the mandate discussion, and in the context of the implementation of the revised Animal byproducts Regulation (EC) No 1069/2009, the following additional comments were given: It is suggested to define the requirements for the quantitative reduction of the representative pathogens or indicators according to the final use of the different ABP categories to be processed, similar to those set out in Point 13a, Chapter II of Annex VI to Regulation (EC) No 1774/2002 as amended, with the different ABP categories representing different risks of microbiological contamination of the input material. It is suggested to use the term validation as defined in the glossary of the present document and as elaborated on in the EFSA 2005 opinion on the safety vis-à-vis biological risks of biogas and compost treatment standards of ABPs. 7 It is suggested not to use end product testing as a synonym for the term validation. DOCUMENTATION PROVIDED TO EFSA 1. Letter (ref. n. TG (2009) D/410020 dated 18/01/2010) from the European Commission with a request for technical assistance on the format far applications for new alternative methods for animal by-products REFERENCES CAC (Codex Alimentarius Commission), 1999. Principles and Guidelines for the Conduct of Microbiological Risk Assessment. Available from: www.codexalimentarius.net/web/more_info.jsp?id_sta=357. 1-6. EC (European Commission), 2008. Guidelines for applications for new alternative methods of disposal or use of animal by-products. Available from: http://ec.europa.eu/food/food/biosafety/animalbyproducts/disposal0604_rev_en.pdf 10

APPENDIX A. DRAFT STANDARD FORMAT AS PROVIDED BY COMMISSION SERVICES SECTION I GENERAL PROVISIONS 1. The standard format laid down in Section II shall apply to applications for the authorisation of alternative methods which are submitted by interested parties or by Member States, in accordance with Article 20 of Regulation (EC) No 1069/2009. 2. National contact points which are designated by Member States shall provide information on the competent authority responsible as referred to in Article 20(2) of Regulation (EC) No 1069/2009 to interested parties. The Commission shall publish a list of national contact points on its website. SECTION II STANDARD FORMAT CHAPTER I Language regime 1. Applications shall be submitted in one of the official languages of the European Union as defined in Article I of Regulation 1/1958. 2. Interested parties that submit their applications in a language other than English shall validate the official translation of their application, which EFSA will provide, prior to the assessment. The period referred to In Article 20(5) of Regulation (EC) No 1069/2009 shall only start once the interested party has validated the official translation. CHAPTER II Content of applications 1. Applications shall contain sufficient information on the following points, in order to allow EFSA to assess the safety of their proposed alternative method: (a) the categories of animal by-products which are supposed to be submitted to the alternative method, by reference to the categories referred to in Articles 8,9, and 10 of Regulation (EC) No 1069/2009; (b) the identification and characterisation of hazardous materials according to the following principles: 11

Significant risk materials should be identified separately. For each material, the likelihood of human and animal exposure under normal and emergency/ abnormal operating conditions should be assessed. In case of significant exposure, the potential risk should be assessed. (c) the agent risk reduction according to the following principles: The risk reduction for human and animal health which can be achieved by the process should be estimated on the basis of direct measurements. In case no direct measurement is available, modelling or extrapolation from other processes may also be used. In order to demonstrate effective risk reduction, the identified hazard (e.g. Salmonella) should be quantified both in the input (raw) material and in the resulting output material. For the purpose of this document output material comprises any end-products and by-products deriving from the process. Estimates should be accompanied by evidence. This includes - for measurements - information on the methodology used (sensitivity and reliability of the methods used, nature of samples which have been analysed and evidence that samples are representative (relevant real samples, number of tests performed). If surrogates for prion measurement are used, an explanation should be given of their relevance. In any case it is necessary to provide an evaluation of the validity with the uncertainties involved. (d) the risk containment according to the following principles: The likely effectiveness of the technical measures used to ensure that the risks are contained should be analysed. This analysis should reflect normal and abnormal/ emergency operating conditions including a breakdown of the process. Monitoring and surveillance procedures to demonstrate containment should be specified. If full containment is not achievable, an assessment is required of any potential risk. (e) the identification of interdependent processes according to the following principles: Possible indirect impacts which may influence the risk reduction capacity of a particular process should be evaluated. Indirect impacts may arise from transport, storage and safe disposal of end-products and by-products of a process. (f) the intended end use of the products according to the following principles: The intended end use of products and by-products of a process should be specified. The likely risks involved should be calculated from the risk reduction estimated in accordance with (c), which may arise to human and animal health. 2. Applications shall be submitted with documentary evidence, in particular a flow diagram showing the functioning of the process, the evidence indicated under point (1c), as well as other evidence aiming to substantiate the explanation given under the framework set out under point 1. 3. Applications shall include a contact address for the interested party, which shall include indications of the name and full address, telephone and/or fax numbers and/or the electronic mail address of a particular contact person that is responsible as or on behalf of the in interested party. 12