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Ensuring the safe supply of animal-derived ingredients for animal feed
24 Ensuring the safe supply of animal-derived ingredients for animal feed S. L. Woodgate, Foodchain and Biomass Renewables Association (FABRA), UK
Abstract: Animal by-products are potentially important sources of nutrients for animals if they are safely sourced and processed into ingredients for animal feeds. The current status of the industry is contrasted with the historical situation, and the new initiatives taken in recent years to ensure safe supply of animal-based feeds are discussed in detail. Key words: animal by-products, fish by-products, processed animal proteins (PAP), rendered fats, fish oil, rendering, processing, risk analysis, HACCP.
24.1 Introduction Livestock and fishery industry by-products have been utilised in animal feeds for over a century. After the by-product raw materials are transformed into products, these may be used as ingredients by the animal feeds industry. The rendering industry focuses on the processing of by-products from terrestrial (livestock) animals and produces protein meals termed meat and bone meal (MBM) of processed animal proteins (PAP), and rendered animal fats, normally called tallow. The fish by-products industry deals with fishery by-products and fish not intended or used for human consumption and produces protein meals termed fishmeals and fats called fish oils. This chapter will consider the current requirements for ensuring the safe supply of these animal-derived ingredients for animal-based feeds. In reaching conclusions about the current levels of safety, it is important to consider the scope of the industry and its history through the twentieth century. The most significant changes in these sectors have resulted from the bovine spongiform encephalopathy (BSE) epidemics, first in the UK
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and later in the rest of Europe. The way in which legislation and the rendering industry have interacted from 1996 in the UK and from 2001 in Europe will be discussed in some detail. The role of risk assessment will be considered in relation to the categorisation of animal by-products and their subsequent processes, and lastly their uses, including in animal feeds, will be discussed. Global standards, which have slowly become more harmonised, are presented and discussed. In terms of regulation and controls, however, Europe still leads the way. Therefore, a summary of the current EU regulations will be given together with some thoughts on how the future may change both in the EU and more widely afield.
24.2 The animal livestock industry and the origin of animal by-products (ABP) The terrestrial livestock sector relies heavily on an essential and usually invisible industry operated by the animal by-products processers or renderers. In the past, renderers in particular have been termed the ‘Invisible Industry’, but more recently the industry has been described as ‘Essential Rendering’ (Meeker, 2006). However, in reality the processor of land or fishery by-products operates an important service on a truly global stage. The modern ABP processing industry is illustrated diagrammatically in Fig. 24.1. Broadly, the basic principles are very simple. Raw animal or fish by-product contains high levels of moisture (~65% on average) and microbial load. The primary objective is to stabilise the raw material, by heating it to in excess of 80°C, to effect a microbiological inactivation. As a result, water is also evaporated, and as a further consequence, the fat is separated or ‘rendered’ from the other solid components. After a further physical separation such as centrifuging or expeller pressing, two products are produced: a high protein meal and a liquid fat. The terminology varies between the sectors. For rendering, rendered animal fat is usually called ‘tallow’ and the protein meal is termed either meat and bone meal (MBM) or processed animal protein (PAP). For fishery by-products, the protein is termed fishmeal and the fat is termed fish oil.
24.2.1
Rendering prior to the transmissible spongiform encephalopathy (TSE)/BSE crisis In early years, rendering plants were in general smaller, mainly local to abattoirs and therefore centres of human population. What happened thereafter included the establishment of larger, more centralised rendering plants to a great extent, to take the benefits of economy of scale. In addition there was a switch from mainly batch processing to mainly continuous processing as new process and equipment developments were made. All of these processes were regulated to a certain extent by national regulators or authorities.
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Raw ABP
Size reduciton Sized raw material Processing; dehydration and sterilisation
Heat (Steam)
Separation Crude Rendered Fat Filtration
Process condensate
Wastewater treatment
Protein press cake Milling Processed Protein Meal Processed animal protein [PAP] or Meat & bone meal [MBM]
Rendered Animal Fat (Tallow) Storage
Storage
Product despatch
Product despatch
Fig. 24.1 Animal by-products: schematic process flow diagram.
However, in retrospect it is clear that not all standards in the European Union were equal or even equivalent. A first attempt to gain some sort of ‘level playing field’ in the EU was an agreement between Member States to publish the Animal Waste Directive which started the process of risk analysis and the establishment of process parameters. Subsequently, this directive was amended many times during the period 1990–2001, as new findings with regard to the safe processing of ABPs and the inactivation of TSEs were published. In contrast to these dramatic changes, the fish byproducts industry has not altered dramatically over the last 20 years.
24.3 Rendering process evaluation As a prelude to the actual TSE inactivation tests described below, a series of process evaluations were completed to confirm the real process parameters for a range of generic process systems to be evaluated (Woodgate, 1994). This preliminary work was necessary to confirm the following for process systems having the characteristics of type (batch or continuous), pressure (atmospheric, above, vacuum), and fat level (de-fatted, natural fat, added
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fat); also, the particle size of the raw material was confirmed for each system. Thereafter the following characteristics were determined for each process under consideration: the proportion of fat present; the minimum transit time under normal and maximum throughputs; and the minimum and maximum times during the transit temperature profile. For the latter parameters, it was first required to determine the dynamics of different rendering process systems. An insoluble marker was developed to be able to determine the minimum residence times in continuous rendering cookers. Manganese dioxide (MnO2) was chosen, as it is heat stable and can be prepared into a suitable form (as a briquette) for introduction into the rendering process. Importantly, manganese is present in animal by-products at rather low levels and would therefore not interfere with the test itself. These residence time studies have subsequently found continued use in the validation of rendering process plants under the animal by-products regulations in Europe. As an integral part of understanding and minimising TSE risk, there was a need to study the potential for rendering systems to inactivate TSE agent. Most of the information about processing parameters used in Europe today originates from research into the inactivation by rendering of BSE and scrapie (TSEs) conducted in the UK between 1990 and 1994. The inactivation studies were published in two separate papers, one dealing with BSE, the other with scrapie (Taylor et al., 1995, 1997).The TSE inactivation studies reported by Taylor et al. were the source of the specific time and temperature conditions that have since been applied to the EU rendering systems.
24.4 The TSE/BSE crisis and its implications 24.4.1 The European approach Prior to 1988 animal by-products of all types were mixed together and rendered, usually in a local rendering process plant, and all types of animal proteins and fats were potentially used in animal feeds. The main aspect of risk management in this period was one of salmonella control in the protein meal. This situation changed dramatically with the emergence of TSE/BSE. BSE (in bovines) is one member of the cluster of prion diseases denoted TSE, and distinguished from scrapie in sheep and goats. MBM in animal feeds have been associated with the emergence of BSE in cattle in the UK, as the most likely vector for the infectivity was the early epidemiology pointing in the direction of infected MBM being used in feed for bovines. This route of infection has not been seriously disputed. Subsequently it became accepted that there was a risk to humans from consuming meat from animals fed feed infected with BSE agent. However, in animals slaughtered for meat consumption, a different approach was being taken. A multiple approach to human safety was taken in the UK. Firstly, all cattle over a certain age (30 months) were slaughtered and disposed of outside the food chain. Secondly, all bovines under 30 months
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of age and also all adult ovines slaughtered to produce meat for human consumption had certain risk organs removed from the food chain. These materials are termed specified risk materials (SRM) and include the brain, spinal cord, intestine and other organs which have a risk of containing TSE infectivity. 24.4.2 Global approaches The main approaches to prevent spread of TSE diseases in non-European countries have been to prohibit the use of certain tissues for use in animal feeds, rather than prohibit them from being rendered per se. Canada enacted an ‘enhanced feed ban’ based upon a ‘short list’ of specified ruminant byproducts in July 2007. Under the enhanced feed ban, producers can no longer feed any animal products containing SRM to livestock, and abattoirs must properly identify SRM to ensure that it is removed from the feed system. In addition, a permit from the Canadian Food Inspection Agency (CFIA) is required to handle, transport or dispose of cattle carcasses and certain cattle tissues. This system enables continuous control over SRM, so that it does not enter the animal feed system. Specified risk material include the skull, brain, trigeminal ganglia (nerves attached to the brain), eyes, tonsils, spinal cord, and dorsal root ganglia (nerves attached to the spinal cord) of cattle aged 30 months or older, and the distal ileum (portion of the small intestine) of cattle of all ages. The USA enacted an animal feed ban based upon a ‘short list’ of older dead animals and some specified ruminant by-products in April 2010. The US Food and Drug Administration (FDA) amended the agency’s regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. This rule was effective from 27 April, 2009. These materials include the following: the entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcasses of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSEpositive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15% insoluble impurities; and mechanically separated beef that is derived from the materials prohibited by this rule.
24.5 Processing of animal by-products 24.5.1 Animal by-products and categorisation The key first step in the EU regulations relates to categorisation of the animal by-products. This is accomplished in accordance with the risk of these by-products to animals and humans. The key aspect of the categorisation relates to the risk assessments described in Section 24.4.1. The three categories are shown in Table 24.1.
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Table 24.1
Summary of EU categories of animal by-products
Category
Animal by-products per category (non-exhaustive)
1
• Animals suspected of being infected by a TSE • Specified risk material, and entire bodies of dead animals containing specified risk material • Products of animal origin containing residues of environmental contaminants such as PCBs and dioxins if such residues exceed the permitted level laid down by Community legislation Mixtures of Category 1 material with either Category 2 material or Category 3 material
2
• Products of animal origin containing residues of veterinary drugs and contaminants if such residues exceed the permitted level laid down by Community legislation • Animals and parts of animals that die other than by being slaughtered for human consumption, including animals killed to eradicate an epizootic disease Mixtures of Category 2 material with Category 3 material
3
• Animal by-products or parts of slaughtered animals which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons • Parts of slaughtered animals which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcasses that are fit for human consumption in accordance with Community legislation
24.5.2 ABP processing methods The processing methods used for both land and fishery by-products in Europe are actually just a reflection of the global industry systems, as there are no unique systems used in one part of the world and not in others. Although practical variations between the basic processing methods do occur, both from one continent to another and also between companies within the same country, the key criteria for describing different rendering systems are as follows: • Batch or continuous • Natural fat, de-fatted, added fat • Atmospheric, below atmospheric pressure (‘vacuum’), above atmospheric pressure (‘pressure’). 24.5.3 Validation and safety of processing methods The principles of rendering validation are based upon the experimental protocols for BSE and scrapie inactivation described in Woodgate (1994). There are seven systems currently approved for the processing of land
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animal and fishery by-products. Of these systems, methods 1, 2, 3, 4 and 5 were set up to meet the requirements of maximum TSE inactivation (from the processing criteria that were established as a result of specific TSE inactivation experiments described above). Other methods were developed to meet exacting microbiological standards. One method (Method 6) is specifically approved for the processing of fish by-products, using a special hydrolysis method only, and a further method (Method 7) is approved for any process that is able to meet very stringent microbiological clearance standards.
24.5.4 Process evaluation and risk reduction Rendering processes in Europe are approved in accordance with strict hygiene principles which use HACCP systems to deliver the objectives of producing safe products for a wide variety of uses. The principles of HACCP systems are, of course, well known and will not be repeated here. What is not so clear is how some of the critical control points (CCPs) are either established or applied. This section discusses the main elements that contribute to the HACCP-based approval regime laid down in the EU Animal By-Products Regulation (ABPR). Residence time With continuous systems, residence time is affected by raw material feed rate (assuming that fat recycle level is constant). The information gained here will be applied again later on, but from a practical point of view the operator will want to choose the maximum feed rate for his plant that can meet the validation criteria. Here is needed a period of trial and error to ascertain the optimum conditions. Temperature Accurately measuring temperature in continuous cookers has been a challenge for engineers. Much of the early work has again involved trial and error. Eventually, it was decided to use thermocouples, housed in sleeves introduced through the wall of the cooker. The design of these units was such that the contact with the temperature of the material being processed was maximised whilst minimising the possibility of physical damage or the effect of the steam jacket on the temperature. To achieve the temperature profile information in the correct format, the thermocouples are placed at positions along the length of the cooker that can be recorded as percentage flow along the cooker, starting with the entrance at 0% and the exit at 100%. Ideally five thermocouples are employed, one close to the entry point, one close to the exit and the other three spaced along the cooker. Normally the thermocouples are linked to a data recorder, so continuous measurement records can be kept of both the validation tests and subsequent day-to-day operations as part of the HACCP system. In
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the actual validation test period, actual temperature values are used to determine the operating criteria. Process approval After the preliminary work has been completed the process can be validated to operate at or above the approval standards. The process should be operating at steady state during the test according to the desired conditions of particle size, raw material feed rate, fat recycle rate and steam pressures to achieve the required temperatures. The key test on the day is the marker flow rate test. The marker test is completed under typical operating conditions which are all recorded for use afterwards. The data recorded is then applied when the results of the manganese marker trials are able to be plotted against time. A typical validation approval issued by the competent authority shows the validation key points as CCPs, with some of the parameters, such as raw material feed rate or fat addition level, described in practical terms, such as pump settings and fat level control respectively. In addition to the physical validation criteria (CCPs) microbiological samples are taken at the time of the validation test and at other times in accordance with EU rules. Each of these microbiological species is determined on samples produced on an ongoing basis (normally hygiene samples taken ‘in house’ and official samples taken from dispatch loads). Conclusions It is possible to validate a rendering process according to the procedure described, and to lay down the CCPs to ensure that the specific validation conditions are met. Following the validation and approval, operation of the plant according to HACCP principles should ensure that the approval standards are continuously met. Revalidations should, in practice, only be required if or when there are significant changes to the process such as a replacement or new cooker unit or a redesign of the plant layout. Of course, when using a HACCP system, it is necessary to lay down the corrective actions following any breach of a CCP. Non-compliances and corrective actions for each CCP are shown in Table 24.2. Non-compliant PAP/MBM produced may be subject to recall and reprocessing.
24.5.5 Current legislation pertaining to ABP The current and main legislative instrument for both land and fishery byproduct processing in Europe is called the Animal By-Products Regulation (ABPR) (1069/2009). It is supplemented by an implementing Regulation (ABPR-IR) 142/2011. The primary regulation is very extensive and the full title conveys the level of interest and input into the framing of this piece of legislation by both the public (European Parliament) and EU Member State governments (Council). The implementing regulation lays down all of
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Non-compliance and corrective action for CCPs
CCP
Non-compliance and corrective action
1
Place any worn anvils or breakers to ensure minimum particle size. Re-process PAP/MBM produced under non-compliant conditions. Ensure maximum feed rate is not exceeded. (In practice, control with safety margin.) Re-process PAP/MBM produced under non-compliant conditions. Ensure maximum fat addition rate is not exceeded. (In practice, control with safety margin.) Re-process PAP/MBM produced under noncompliant conditions. Ensure that exit temperature does not fall below minimum temperature. Establish ‘action zone’. Stop raw material feed from entering action zone, and allow temperature to rise before recommencing raw material feed. Re-process PAP/MBM produced under non-compliant conditions.
2 3 4
the technical requirements of the primary regulation and both are required to be understood and complied with to meet the full requirements. ABPR/1069 includes all of the key aspects regarding categorisation, processing, disposal and use of all animal by-products. The key aspects of the new regulation (1069/2009) are very similar to those described in the predecessor of the current regulation (ABPR/1774) and are described in Woodgate and van der Veen (2004). In respect of materials produced for animal feeds, both (parts of) the ABPR/1069 and ABPR-IR/142 and another regulation, known as the transmissible spongiform encephalopathies (TSE) Regulation (TSER 999/2001), need to be considered together. ABPR/1069 contains important elements regarding the categorisation of raw materials suitable for producing animal feed-grade products. The use of certain products as ingredients for feed for animals used in food production for humans is in principle approved subject to conditions: • Category 3 is the only category able to be used in the foodchain. • There are strict processing conditions laid down. • There is a prohibition on intra-species recycling. When considering animal products as ingredients for animal feeds, the TSER is both important and directly relevant. Interestingly it is the TSER that actually defines what is by meant an animal; i.e. one that is used for producing food for humans. This definition is in contrast to domesticated companion animals and farmed fur animals for which other regulations may apply. The mechanism within the TSER is that it firstly prohibits all animal proteins for use in animal feeds and then (in Annex IV) makes exceptions for those that are allowed to be used. Here any restrictions on use, such as to certain species only, are cited.
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It is important to note that there are no restrictions on the use of rendered animal fats, save the one condition (in the ABPR/ABPR-IR and the TSER) that requires tallow derived from ruminants to have a maximum of 0.15% of insoluble impurities if it is to be used in animal feeds. There are compliance microbiological standards for production of animal products that are intended for use in animal feeds. In the EU three sentinel organisms are used, each having a place within the process and regulatory HACCP system. Products for use in animal feeds are required to meet the following: • Clostridium perfringens: Absent in 1 g • Salmonella sp: Absent in 50 g • Enterobacteriaceae: Samples must meet specific limits.
24.6 Risk identification and management in animal feeds Some risk analyses for the production chain for feed materials manufactured from the following materials have been developed that build upon HACCP principles and consider all of the potential risks to the food chain. These risk analyses list the safety hazards that may occur throughout the production chains, up to the delivery of the feed material to the feed compounding industry. This work has been completed by industry collaboration with the European Feed Ingredients Platform (EFIP) in relation to the proposed EU scheme known as the European Feed Ingredients Safety Certification (EFISC). The risk analyses indicate the level of risk that each hazard will pose to feed safety and whether that is to be controlled by a measure as part of a pre-requisite programme (PRP) or by a critical control point (CCP). The risk analyses list applicable legal trade limits and formulate necessary measures that need to be taken to reduce the hazards to acceptable levels. One of the key areas of legislative control on animal feeds is in the arena of dioxins, dioxin-like PCBs and non-dioxin-like PCBs. Here in Europe there are maximum limits set for feed ingredients and finished feeds. There are also action limits set, at which actions should be taken to prevent the likelihood of contamination of finished feed at critical and dangerous levels (for details see also Chapter 8).
24.6.1 Feed contamination with MBM In the EU there are extremely onerous regulatory controls in place to control the safety of animal feeds. The feed ban, discussed above, effectively requires that samples of finished feed are tested to ensure that they do not contain any animal proteins. The natural presence of bones in nearly all types of animal proteins used in animal feeds affords the possibility of using
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the bones present as a marker to indicate the presence of animal proteins in finished animal feeds. The policy of ‘zero tolerance’ in respect of the presence of MBM in animal feeds adopted in the wake of the BSE epidemics meant that effectively if just one ‘terrestrial’ animal bone was found in the sample of feed, then it was deemed to be contaminated with MBM. This very simplistic approach was probably the most practical way forward at the time, but the zero tolerance soon led to several different and unforeseen consequences (details on the methodologies applied in the detection of animal by-products are presented in Chapter 6).
24.6.2 Current EU status and initiatives Details of the EU TSE regulation may change according to the procedures laid down in the EU legislation. This approach involves all of the EU 27 Member States, in the form of the Standing Committee on the Foodchain and Animal Health (SCoFCAH), approving proposed amendments. Any of the recent amendments are almost certain to have been subject to risk assessment beforehand. Therefore, any successful amendment to what is a very strictly limited list of approved animal feed ingredients, will have been subjected to a three-tier level of approval, i.e. EFSA, the Commission, the Member States. What is more, the European Parliament also has a right of scrutiny and interjection if it so wishes. Table 24.3 summarises the materials that are currently (2010) prohibited and authorised in animal feeds in the EU. There have been and continue to be a range of initiatives in play in Europe to try to achieve the goal of more approvals for processed animal proteins. In the EU there are several layers of regulatory controls in place that form an overarching approach to controlling the safety of animal feeds. The key tool is the official method for detection of bone particles in animal feeds. This method was adopted in the very early days of the (animal) feed ban and in principle was a method of detecting meat and bone meal (MBM) in compound animal feed. It is important to note that the method is validated in respect of terrestrial bones and is able to differentiate land animal bones from fish bones. This is important, as fish meal (also a processed animal protein according to the ABPR) was not banned for use in pig and poultry feeds. One of these consequences was that even feathermeal was prohibited as it too contains (poultry) bones and this could not be differentiated from any other bones that might have been present if MBM was included in the animal feed. On the other hand, vegetable root crops such as sugar beet were found to contain mammalian bone fragments from time to time. This situation was certainly unforeseen and on investigation was found to be related to contamination in the growing fields from the bones of dead mice or birds. This latter finding did lead to a change in legislation: an aspect of tolerance linked to a risk assessment was introduced to achieve a pragmatic solution that did not stop beet harvesting if just one
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Table 24.3
Summary of EU feed legislation: prohibited and approved materials Prohibited Permanent ban
Ruminants
•
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•
Non-ruminant farm animals (pig and poultry)
Authorised
Temporary ban
Animal protein and feeding stuffs containing mammalian protein (PAPs, blood products, etc.) Feeding stuffs containing PAPs or DCP and TCP of animal origin
With restrictions
Completely
•
• • • •
• • •
Non-ruminant PAPs Proteins of ruminant origin (gelatine, blood, PAPs)
• • • •
Fish
Fishmeal for unweaned ruminants (from 2008, conditions of use)
• • •
Fishmeal (conditions of use) DCP and TCP (conditions of use) Non-ruminant blood products (conditions of use) Animal fats (of ruminant origin with special processing)
•
Non-ruminant blood meal and blood products (conditions of use) Fishmeal (conditions of use) DCP, TCP of animal origin (conditions of use)
•
• • • •
•
Milk, milk-based products and colostrum Eggs and egg products Animal fat Hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins, feathers and fish Gelatine from non-ruminants Milk, milk-based products and colostrum Eggs and egg products Animal fat Gelatine derived from non-ruminants Hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins Milk, milk-based products and colostrum Eggs and egg products
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mammalian bone fragment was found in a consignment. Nonetheless, the issue of ‘tolerance’ has not yet been fully agreed either in respect of (cross) contamination of one animal protein in another PAP or in terms of speciespure PAP in finished or compound feeds. The approach of the European Commission with regard to risk in animal feed is based upon the avoidance of ‘ruminant protein’ (of any category 1, 2, 3) in any farmed animal feed, to avoid any chance of it being ingested by ruminants. Therefore many of the control tools concentrate on the detection of ruminant protein at low levels both in PAP and in animal feeds. The ‘tolerance’ level in each is expected to be different, and the proposals under consideration are discussed accordingly. On a more marketoriented note, EFPRA have decided to term the PAP made from pigs and poultry (both monogastric animals) monoPAP in order to differentiate it from other types of PAP, such as ruminant PAP (used in petfoods) and fishmeal (fishPAP). Several key initiatives have been taken to try to achieve the following objectives: • Differentiate Category 3 PAP from Category 1 or 2 protein meals using a marker. • Determine the risk (by risk assessment) of additional TSE cases in Europe by the cross-contamination of animal feeds with ruminant protein. • Develop a method for species detection suitable to detect ruminant proteins in non-ruminant PAPs, with appropriate tolerances. • Develop an enhanced system that delivers a secure supply of speciespure PAP: from the source of the Category 3 ABP to the delivery of the PAP to the feed mill and farm. • Establish a new official method in Europe for the detection of ruminant proteins in finished or compound feeds. • Work with all stakeholders in the ‘foodchain’ to develop a strategy that meets the objectives of all members. In practice, this work has progressed over the last five years with a range of projects and studies being completed by both industry and official laboratories. Importantly, in this period, the European Commission has established a central laboratory of expertise in the subject of animal proteins. The Community Reference Laboratory – Animal Proteins (CRL-AP) is based in Gembloux, Belgium, and has been involved since 2007 with many aspects of the animal protein work. Markers This work involving EFPRA and the EU Joint Research Centre (JRC) in Geel, Belgium, developed and validated a marker, glycerol triheptanoate (GTH), for addition to Category 1 and 2 processing plants.
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Risk assessment EFPRA commissioned an independent report on the potential risk from cross-contamination of ruminant protein by DNV, a worldwide risk assessment company. The model used was the same one used by the European Food Safety Authority (EFSA) when calculating the risk of crosscontamination by MBM in animal feeds. The EFPRA/DNV Risk Report results indicate that if there is a limit of detection as high as 5% ruminant protein in monoPAP (together with a limit of detection of 1% monoPAP in ruminant feed), and that these levels applied to all of the cattle feed produced in the EU, then the risk of additional BSE cases would be extremely low and significantly lower than the value reported in the EFSA’s ‘Opinion of the Scientific Panel on Biological Hazards on the quantitative risk assessment of the animal BSE risk posed by meat and bonemeal with respect to the residual BSE risk’ (EFSA, 2005). It is also noteworthy that the European Commission have updated the ‘TSE Roadmap’ and have published a TSE Roadmap 2 (2010) with a view to the possible adaptation of certain measures of the current feed ban. PAP species identification This work has been conducted by EFPRA/CCL in conjunction with the CRL-AP. The outcome has been a development of an ELISA-based method (MelisatekTM) that is able to detect 1% ruminant protein (processed up to 137°C under pressure) in a mixture with non-ruminant proteins at a sensitivity of 100%. LYNXX: a secure supply chain This system is still under development, but is considered to be important in bringing confidence into the supply of monoPAP for animal feeds. One of the main aspects of LYNXX is the requirement for segregation at all parts of the chain, beginning with slaughterhouses, then process (rendering) plants, and finally feed mills. Specific transport codes of practice will also apply at the appropriate stages. Official methods Development and validation of methods is the responsibility of the CRL-AP and the European Commission. Two major EU projects have assisted in this process: • EU R&D project ‘STRATFEED’: Objective to improve and if possible quantify official microscopy method for animal feeds and to develop other species detection methods. • EU R&D project ‘SAFEED-PAP’: Objective to continue developments above and to develop and validate a suitable method that enhances the official microscopy method.
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It now appears that a new official method may be validated within the next nine months or so. At least two PCR methods for detecting ruminant proteins in finished feed at a level of 0.1% are under consideration to be included in an inter-laboratory study (ring trial) to be completed in 2011. If successful, one or more PCR methods could be published as new ‘official EU methods’. Stakeholders EFPRA are members of a group bringing together different individual sector associations: farmers, red meat, poultry meat, meat processors and animal feeds. This group have come together to work on both the technical and political aspects of gaining the authorisation of monoPAP for use in animal feeds.
24.6.3 EU rapid alert In Europe there is a system in place termed the ‘Rapid Alert System for Food and Feed’. It has been established in response to ‘crises’ in the food chain that have occurred in the last decade. Apart from BSE (which as an epidemic would probably not have been prevented by such a system), the main initiator was the Belgian dioxin crisis. The rapid alert system is organised to try to prevent any future crises, and is operated effectively by national competent authorities that are required to notify the Commission of their own findings. As a result, the information is publicly available as soon as possible, so that all involved in the chain may be able to take some actions. Some examples appearing in the rapid alert reports are microbiological contamination, bone particles, chemical contaminants such as dioxin/PCBs or natural toxins (mycotoxins and others). None of these contaminants should, in principle, be present in quality feed products, but if mistakes occur and these contaminants do find their way past the first safety net, then this system can be regarded as a further safeguard.
24.6.4 Codex Alimentarius Globally, all feed regulation requirements should conform with the Codex Alimentarius Code of Practice on Good Animal Feeding (CAC/RCP 54-2004). This Codex Code has been converted to a Feed Manual, published jointly by FAO and IFIF: Good Practices for the Animal Feed Industry. Currently, there is still a worldwide ban on the use of ruminant proteins in ruminant feeds. This position, first proposed in UK and then in Europe, has become the norm for ruminants. However, in many parts of the world ruminants are allowed to be fed non-ruminant animal proteins and animal fats from all species, including ruminant-derived fat.
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As described in Section 24.4.2, Canada and the USA have enacted ‘enhanced feed bans’ based upon the removal of certain high-risk raw materials from the feed and food chain.
24.7 Future trends The European approach of ultra-precaution has been rigidly applied for about 10 years, so 2012 and 2013 are important years in Europe. There is high expectation that monoPAP will be authorised for aquafeeds in 2012 or 2013, and for pigs and poultry soon after. The demand for monoPAP is high, both inside and outside Europe, but as a prerequisite for export from Europe for use in animal feeds, the monoPAP must be legally saleable within the EU. Now with the technical solutions on the horizon and a high demand for the supply of animal-derived nutrients, the future for the European animal by-products sector looks promising.
24.8 References Codex Alimentarius: Code of Practice on Good Animal Feeding, CAC/RCP 54-2004, www.codexalimentarius.net Commission Regulation (EU) No. 142/2011 of 25 February 2011 implementing Regulation (EC) No. 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive, OJ, L54/1, 26 February 2011. EFIP benchmark standard and EFISC, www.efip-ingredients.org efsa, 2005, Opinion of the Scientific Panel on Biological Hazards on the quantitative risk assessment of the animal BSE risk posed by meat and bone meal with respect to the residual BSE risk, EFSA Journal, 257, 1–30. efsa, 2007, Opinion of the Scientific Panel on Biological Hazards on a request from the European Parliament on certain aspects related to the feeding of animal proteins to farm animals, EFSA Journal, 576, 1–41. IFIF/FAO Manual: Good Practices for the Animal Feed Industry, www.ifif.org meeker d l (ed.), 2006, Essential Rendering. Published by the National Renderers Association, the Fats and Proteins Research Foundation and the Animal Protein Producers Industry. ISBN 0-9654660-3-5. Regulation (EC) No. 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ, L147, 31 May 2001. Regulation (EC) No. 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption, OJ, L273, 10 October 2002. 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, L300/1, 14 November 2009.
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SAFEED-PAP: http://safeedpap.feedsafety.org STRATFEED: http://www.stratfeed.cra.wallonie.be taylor d m, woodgate s l, and atkinson m j, 1995, Inactivation of the bovine spongiform encephalopathy agent by rendering procedures, Vet Rec, 9 December 1995, 137, 605–610. taylor d m, woodgate s l, fleetwood a j, and cawthorne r j g, 1997, Effect of rendering procedures on the scrapie agent, Vet Rec, 20–27 December 1997, 141, 643–649. tse roadmap 2, (2010), http://ec.europa.eu/food/food/biosafety/tse_bse/docs/ roadmap_2_en.pdf woodgate s l, 1994, Rendering systems and BSE agent deactivation, Livestock Production Science, 38, 47–50. woodgate s l and van der veen j t, 2004, The role of fat processing and rendering in the European Union animal production industry, Biotechnol Agron Soc Environ, 8(4), 283–294.
24.9 Appendix: glossary of terms EU Food Regulations (853/2004) The EU Food Regulations (of which this is one of a series of five) lay down hygiene and processing conditions for certain edible co-products such as carcase fat and bones. EU Animal By-products Regulation (ABPR/1774 as amended) The EU Animal By-products Regulation 1774/2002 lays down health rules concerning animal by-products not intended for human consumption. EU Animal By-products Regulation (ABPR/1069) The EU Animal By-products Regulation 1069/2009 lays down health rules concerning animal by-products not intended for human consumption. EU Animal By-products Implementing Regulation (ABPR-IR/142) The EU Animal By-products Implementing Regulation 142/2011. EU TSE Regulation (999/2001 as amended) The EU TSE regulation (TSER) lays down specific details regarding removal of Specified Risk Materials (SRM) from bovines and ovines, and age limits for BSE testing. The TSER also contains a list of non-approved and approved derived products that may be used in feeds for farmed animals. Edible co-products Materials that are processed in accordance with the food regulations, from which derived products may be used in animal feed. The process used is termed melting or edible rendering.
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Category 3 animal by-products Category 3 animal by-products comprise exclusively animal by-products derived from approved animals. These approved animals are slaughtered in an approved slaughterhouse and are considered as fit for human consumption after an ante- and post-mortem veterinary inspection in accordance with the Community legislation. The process used is termed rendering. Derived products Products derived from processing of certain edible materials or animal byproducts in accordance with the EU Food, ABPR and TSE regulations. Rendered animal fats Animal fats derived from edible co-products or Category 3 animal byproducts by melting/rendering. Processed Animal Proteins (PAP) Animal proteins derived from edible co-products or Category 3 animal byproducts by melting/rendering. Approved products Blood products, gelatin, hydrolysed proteins and di-calcium phosphate are approved products in the ABPR/1774. However, the TSER/999 currently approves the above for use in animal feed and also approves the use of non-ruminant blood meal for use in aqua-feeds only. Feed ingredient Any derived product used in feed for animals farmed for food production. Animal feed Feed for animals farmed for food production, including terrestrial and aquatic animals. Petfood Feed for pet species normally nourished and kept as companions, but not consumed by humans. Fur animal feed Feed for farmed fox or mink species, not consumed by humans. STRATFEED An EU research project on ‘Strategies and methods to detect and quantify mammalian tissues in feedingstuffs’.
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SAFEED-PAP An EU project on ‘Species-specific detection of processed animal proteins in animal feed’. TSE Roadmap A Communication to the European Parliament and the Council which outlines areas where future possible changes to EU legislation on TSEs could be made.
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Abstract: Animal by-products are potentially important sources of nutrients for animals if they are safely sourced and processed into ingredients for animal feeds. The current status of the industry is contrasted with the historical situation, and the new initiatives taken in recent years to ensure safe supply of animal-based feeds are discussed in detail. Key words: animal by-products, fish by-products, processed animal proteins (PAP), rendered fats, fish oil, rendering, processing, risk analysis, HACCP.
24.1 Introduction Livestock and fishery industry by-products have been utilised in animal feeds for over a century. After the by-product raw materials are transformed into products, these may be used as ingredients by the animal feeds industry. The rendering industry focuses on the processing of by-products from terrestrial (livestock) animals and produces protein meals termed meat and bone meal (MBM) of processed animal proteins (PAP), and rendered animal fats, normally called tallow. The fish by-products industry deals with fishery by-products and fish not intended or used for human consumption and produces protein meals termed fishmeals and fats called fish oils. This chapter will consider the current requirements for ensuring the safe supply of these animal-derived ingredients for animal-based feeds. In reaching conclusions about the current levels of safety, it is important to consider the scope of the industry and its history through the twentieth century. The most significant changes in these sectors have resulted from the bovine spongiform encephalopathy (BSE) epidemics, first in the UK
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and later in the rest of Europe. The way in which legislation and the rendering industry have interacted from 1996 in the UK and from 2001 in Europe will be discussed in some detail. The role of risk assessment will be considered in relation to the categorisation of animal by-products and their subsequent processes, and lastly their uses, including in animal feeds, will be discussed. Global standards, which have slowly become more harmonised, are presented and discussed. In terms of regulation and controls, however, Europe still leads the way. Therefore, a summary of the current EU regulations will be given together with some thoughts on how the future may change both in the EU and more widely afield.
24.2 The animal livestock industry and the origin of animal by-products (ABP) The terrestrial livestock sector relies heavily on an essential and usually invisible industry operated by the animal by-products processers or renderers. In the past, renderers in particular have been termed the ‘Invisible Industry’, but more recently the industry has been described as ‘Essential Rendering’ (Meeker, 2006). However, in reality the processor of land or fishery by-products operates an important service on a truly global stage. The modern ABP processing industry is illustrated diagrammatically in Fig. 24.1. Broadly, the basic principles are very simple. Raw animal or fish by-product contains high levels of moisture (~65% on average) and microbial load. The primary objective is to stabilise the raw material, by heating it to in excess of 80°C, to effect a microbiological inactivation. As a result, water is also evaporated, and as a further consequence, the fat is separated or ‘rendered’ from the other solid components. After a further physical separation such as centrifuging or expeller pressing, two products are produced: a high protein meal and a liquid fat. The terminology varies between the sectors. For rendering, rendered animal fat is usually called ‘tallow’ and the protein meal is termed either meat and bone meal (MBM) or processed animal protein (PAP). For fishery by-products, the protein is termed fishmeal and the fat is termed fish oil.
24.2.1
Rendering prior to the transmissible spongiform encephalopathy (TSE)/BSE crisis In early years, rendering plants were in general smaller, mainly local to abattoirs and therefore centres of human population. What happened thereafter included the establishment of larger, more centralised rendering plants to a great extent, to take the benefits of economy of scale. In addition there was a switch from mainly batch processing to mainly continuous processing as new process and equipment developments were made. All of these processes were regulated to a certain extent by national regulators or authorities.
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Raw ABP
Size reduciton Sized raw material Processing; dehydration and sterilisation
Heat (Steam)
Separation Crude Rendered Fat Filtration
Process condensate
Wastewater treatment
Protein press cake Milling Processed Protein Meal Processed animal protein [PAP] or Meat & bone meal [MBM]
Rendered Animal Fat (Tallow) Storage
Storage
Product despatch
Product despatch
Fig. 24.1 Animal by-products: schematic process flow diagram.
However, in retrospect it is clear that not all standards in the European Union were equal or even equivalent. A first attempt to gain some sort of ‘level playing field’ in the EU was an agreement between Member States to publish the Animal Waste Directive which started the process of risk analysis and the establishment of process parameters. Subsequently, this directive was amended many times during the period 1990–2001, as new findings with regard to the safe processing of ABPs and the inactivation of TSEs were published. In contrast to these dramatic changes, the fish byproducts industry has not altered dramatically over the last 20 years.
24.3 Rendering process evaluation As a prelude to the actual TSE inactivation tests described below, a series of process evaluations were completed to confirm the real process parameters for a range of generic process systems to be evaluated (Woodgate, 1994). This preliminary work was necessary to confirm the following for process systems having the characteristics of type (batch or continuous), pressure (atmospheric, above, vacuum), and fat level (de-fatted, natural fat, added
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fat); also, the particle size of the raw material was confirmed for each system. Thereafter the following characteristics were determined for each process under consideration: the proportion of fat present; the minimum transit time under normal and maximum throughputs; and the minimum and maximum times during the transit temperature profile. For the latter parameters, it was first required to determine the dynamics of different rendering process systems. An insoluble marker was developed to be able to determine the minimum residence times in continuous rendering cookers. Manganese dioxide (MnO2) was chosen, as it is heat stable and can be prepared into a suitable form (as a briquette) for introduction into the rendering process. Importantly, manganese is present in animal by-products at rather low levels and would therefore not interfere with the test itself. These residence time studies have subsequently found continued use in the validation of rendering process plants under the animal by-products regulations in Europe. As an integral part of understanding and minimising TSE risk, there was a need to study the potential for rendering systems to inactivate TSE agent. Most of the information about processing parameters used in Europe today originates from research into the inactivation by rendering of BSE and scrapie (TSEs) conducted in the UK between 1990 and 1994. The inactivation studies were published in two separate papers, one dealing with BSE, the other with scrapie (Taylor et al., 1995, 1997).The TSE inactivation studies reported by Taylor et al. were the source of the specific time and temperature conditions that have since been applied to the EU rendering systems.
24.4 The TSE/BSE crisis and its implications 24.4.1 The European approach Prior to 1988 animal by-products of all types were mixed together and rendered, usually in a local rendering process plant, and all types of animal proteins and fats were potentially used in animal feeds. The main aspect of risk management in this period was one of salmonella control in the protein meal. This situation changed dramatically with the emergence of TSE/BSE. BSE (in bovines) is one member of the cluster of prion diseases denoted TSE, and distinguished from scrapie in sheep and goats. MBM in animal feeds have been associated with the emergence of BSE in cattle in the UK, as the most likely vector for the infectivity was the early epidemiology pointing in the direction of infected MBM being used in feed for bovines. This route of infection has not been seriously disputed. Subsequently it became accepted that there was a risk to humans from consuming meat from animals fed feed infected with BSE agent. However, in animals slaughtered for meat consumption, a different approach was being taken. A multiple approach to human safety was taken in the UK. Firstly, all cattle over a certain age (30 months) were slaughtered and disposed of outside the food chain. Secondly, all bovines under 30 months
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of age and also all adult ovines slaughtered to produce meat for human consumption had certain risk organs removed from the food chain. These materials are termed specified risk materials (SRM) and include the brain, spinal cord, intestine and other organs which have a risk of containing TSE infectivity. 24.4.2 Global approaches The main approaches to prevent spread of TSE diseases in non-European countries have been to prohibit the use of certain tissues for use in animal feeds, rather than prohibit them from being rendered per se. Canada enacted an ‘enhanced feed ban’ based upon a ‘short list’ of specified ruminant byproducts in July 2007. Under the enhanced feed ban, producers can no longer feed any animal products containing SRM to livestock, and abattoirs must properly identify SRM to ensure that it is removed from the feed system. In addition, a permit from the Canadian Food Inspection Agency (CFIA) is required to handle, transport or dispose of cattle carcasses and certain cattle tissues. This system enables continuous control over SRM, so that it does not enter the animal feed system. Specified risk material include the skull, brain, trigeminal ganglia (nerves attached to the brain), eyes, tonsils, spinal cord, and dorsal root ganglia (nerves attached to the spinal cord) of cattle aged 30 months or older, and the distal ileum (portion of the small intestine) of cattle of all ages. The USA enacted an animal feed ban based upon a ‘short list’ of older dead animals and some specified ruminant by-products in April 2010. The US Food and Drug Administration (FDA) amended the agency’s regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. This rule was effective from 27 April, 2009. These materials include the following: the entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle; the brains and spinal cords from cattle 30 months of age and older; the entire carcasses of cattle not inspected and passed for human consumption that are 30 months of age or older from which brains and spinal cords were not removed; tallow that is derived from BSEpositive cattle; tallow that is derived from other materials prohibited by this rule that contains more than 0.15% insoluble impurities; and mechanically separated beef that is derived from the materials prohibited by this rule.
24.5 Processing of animal by-products 24.5.1 Animal by-products and categorisation The key first step in the EU regulations relates to categorisation of the animal by-products. This is accomplished in accordance with the risk of these by-products to animals and humans. The key aspect of the categorisation relates to the risk assessments described in Section 24.4.1. The three categories are shown in Table 24.1.
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Table 24.1
Summary of EU categories of animal by-products
Category
Animal by-products per category (non-exhaustive)
1
• Animals suspected of being infected by a TSE • Specified risk material, and entire bodies of dead animals containing specified risk material • Products of animal origin containing residues of environmental contaminants such as PCBs and dioxins if such residues exceed the permitted level laid down by Community legislation Mixtures of Category 1 material with either Category 2 material or Category 3 material
2
• Products of animal origin containing residues of veterinary drugs and contaminants if such residues exceed the permitted level laid down by Community legislation • Animals and parts of animals that die other than by being slaughtered for human consumption, including animals killed to eradicate an epizootic disease Mixtures of Category 2 material with Category 3 material
3
• Animal by-products or parts of slaughtered animals which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons • Parts of slaughtered animals which are rejected as unfit for human consumption but are not affected by any signs of diseases communicable to humans or animals and derive from carcasses that are fit for human consumption in accordance with Community legislation
24.5.2 ABP processing methods The processing methods used for both land and fishery by-products in Europe are actually just a reflection of the global industry systems, as there are no unique systems used in one part of the world and not in others. Although practical variations between the basic processing methods do occur, both from one continent to another and also between companies within the same country, the key criteria for describing different rendering systems are as follows: • Batch or continuous • Natural fat, de-fatted, added fat • Atmospheric, below atmospheric pressure (‘vacuum’), above atmospheric pressure (‘pressure’). 24.5.3 Validation and safety of processing methods The principles of rendering validation are based upon the experimental protocols for BSE and scrapie inactivation described in Woodgate (1994). There are seven systems currently approved for the processing of land
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animal and fishery by-products. Of these systems, methods 1, 2, 3, 4 and 5 were set up to meet the requirements of maximum TSE inactivation (from the processing criteria that were established as a result of specific TSE inactivation experiments described above). Other methods were developed to meet exacting microbiological standards. One method (Method 6) is specifically approved for the processing of fish by-products, using a special hydrolysis method only, and a further method (Method 7) is approved for any process that is able to meet very stringent microbiological clearance standards.
24.5.4 Process evaluation and risk reduction Rendering processes in Europe are approved in accordance with strict hygiene principles which use HACCP systems to deliver the objectives of producing safe products for a wide variety of uses. The principles of HACCP systems are, of course, well known and will not be repeated here. What is not so clear is how some of the critical control points (CCPs) are either established or applied. This section discusses the main elements that contribute to the HACCP-based approval regime laid down in the EU Animal By-Products Regulation (ABPR). Residence time With continuous systems, residence time is affected by raw material feed rate (assuming that fat recycle level is constant). The information gained here will be applied again later on, but from a practical point of view the operator will want to choose the maximum feed rate for his plant that can meet the validation criteria. Here is needed a period of trial and error to ascertain the optimum conditions. Temperature Accurately measuring temperature in continuous cookers has been a challenge for engineers. Much of the early work has again involved trial and error. Eventually, it was decided to use thermocouples, housed in sleeves introduced through the wall of the cooker. The design of these units was such that the contact with the temperature of the material being processed was maximised whilst minimising the possibility of physical damage or the effect of the steam jacket on the temperature. To achieve the temperature profile information in the correct format, the thermocouples are placed at positions along the length of the cooker that can be recorded as percentage flow along the cooker, starting with the entrance at 0% and the exit at 100%. Ideally five thermocouples are employed, one close to the entry point, one close to the exit and the other three spaced along the cooker. Normally the thermocouples are linked to a data recorder, so continuous measurement records can be kept of both the validation tests and subsequent day-to-day operations as part of the HACCP system. In
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the actual validation test period, actual temperature values are used to determine the operating criteria. Process approval After the preliminary work has been completed the process can be validated to operate at or above the approval standards. The process should be operating at steady state during the test according to the desired conditions of particle size, raw material feed rate, fat recycle rate and steam pressures to achieve the required temperatures. The key test on the day is the marker flow rate test. The marker test is completed under typical operating conditions which are all recorded for use afterwards. The data recorded is then applied when the results of the manganese marker trials are able to be plotted against time. A typical validation approval issued by the competent authority shows the validation key points as CCPs, with some of the parameters, such as raw material feed rate or fat addition level, described in practical terms, such as pump settings and fat level control respectively. In addition to the physical validation criteria (CCPs) microbiological samples are taken at the time of the validation test and at other times in accordance with EU rules. Each of these microbiological species is determined on samples produced on an ongoing basis (normally hygiene samples taken ‘in house’ and official samples taken from dispatch loads). Conclusions It is possible to validate a rendering process according to the procedure described, and to lay down the CCPs to ensure that the specific validation conditions are met. Following the validation and approval, operation of the plant according to HACCP principles should ensure that the approval standards are continuously met. Revalidations should, in practice, only be required if or when there are significant changes to the process such as a replacement or new cooker unit or a redesign of the plant layout. Of course, when using a HACCP system, it is necessary to lay down the corrective actions following any breach of a CCP. Non-compliances and corrective actions for each CCP are shown in Table 24.2. Non-compliant PAP/MBM produced may be subject to recall and reprocessing.
24.5.5 Current legislation pertaining to ABP The current and main legislative instrument for both land and fishery byproduct processing in Europe is called the Animal By-Products Regulation (ABPR) (1069/2009). It is supplemented by an implementing Regulation (ABPR-IR) 142/2011. The primary regulation is very extensive and the full title conveys the level of interest and input into the framing of this piece of legislation by both the public (European Parliament) and EU Member State governments (Council). The implementing regulation lays down all of
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Non-compliance and corrective action for CCPs
CCP
Non-compliance and corrective action
1
Place any worn anvils or breakers to ensure minimum particle size. Re-process PAP/MBM produced under non-compliant conditions. Ensure maximum feed rate is not exceeded. (In practice, control with safety margin.) Re-process PAP/MBM produced under non-compliant conditions. Ensure maximum fat addition rate is not exceeded. (In practice, control with safety margin.) Re-process PAP/MBM produced under noncompliant conditions. Ensure that exit temperature does not fall below minimum temperature. Establish ‘action zone’. Stop raw material feed from entering action zone, and allow temperature to rise before recommencing raw material feed. Re-process PAP/MBM produced under non-compliant conditions.
2 3 4
the technical requirements of the primary regulation and both are required to be understood and complied with to meet the full requirements. ABPR/1069 includes all of the key aspects regarding categorisation, processing, disposal and use of all animal by-products. The key aspects of the new regulation (1069/2009) are very similar to those described in the predecessor of the current regulation (ABPR/1774) and are described in Woodgate and van der Veen (2004). In respect of materials produced for animal feeds, both (parts of) the ABPR/1069 and ABPR-IR/142 and another regulation, known as the transmissible spongiform encephalopathies (TSE) Regulation (TSER 999/2001), need to be considered together. ABPR/1069 contains important elements regarding the categorisation of raw materials suitable for producing animal feed-grade products. The use of certain products as ingredients for feed for animals used in food production for humans is in principle approved subject to conditions: • Category 3 is the only category able to be used in the foodchain. • There are strict processing conditions laid down. • There is a prohibition on intra-species recycling. When considering animal products as ingredients for animal feeds, the TSER is both important and directly relevant. Interestingly it is the TSER that actually defines what is by meant an animal; i.e. one that is used for producing food for humans. This definition is in contrast to domesticated companion animals and farmed fur animals for which other regulations may apply. The mechanism within the TSER is that it firstly prohibits all animal proteins for use in animal feeds and then (in Annex IV) makes exceptions for those that are allowed to be used. Here any restrictions on use, such as to certain species only, are cited.
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It is important to note that there are no restrictions on the use of rendered animal fats, save the one condition (in the ABPR/ABPR-IR and the TSER) that requires tallow derived from ruminants to have a maximum of 0.15% of insoluble impurities if it is to be used in animal feeds. There are compliance microbiological standards for production of animal products that are intended for use in animal feeds. In the EU three sentinel organisms are used, each having a place within the process and regulatory HACCP system. Products for use in animal feeds are required to meet the following: • Clostridium perfringens: Absent in 1 g • Salmonella sp: Absent in 50 g • Enterobacteriaceae: Samples must meet specific limits.
24.6 Risk identification and management in animal feeds Some risk analyses for the production chain for feed materials manufactured from the following materials have been developed that build upon HACCP principles and consider all of the potential risks to the food chain. These risk analyses list the safety hazards that may occur throughout the production chains, up to the delivery of the feed material to the feed compounding industry. This work has been completed by industry collaboration with the European Feed Ingredients Platform (EFIP) in relation to the proposed EU scheme known as the European Feed Ingredients Safety Certification (EFISC). The risk analyses indicate the level of risk that each hazard will pose to feed safety and whether that is to be controlled by a measure as part of a pre-requisite programme (PRP) or by a critical control point (CCP). The risk analyses list applicable legal trade limits and formulate necessary measures that need to be taken to reduce the hazards to acceptable levels. One of the key areas of legislative control on animal feeds is in the arena of dioxins, dioxin-like PCBs and non-dioxin-like PCBs. Here in Europe there are maximum limits set for feed ingredients and finished feeds. There are also action limits set, at which actions should be taken to prevent the likelihood of contamination of finished feed at critical and dangerous levels (for details see also Chapter 8).
24.6.1 Feed contamination with MBM In the EU there are extremely onerous regulatory controls in place to control the safety of animal feeds. The feed ban, discussed above, effectively requires that samples of finished feed are tested to ensure that they do not contain any animal proteins. The natural presence of bones in nearly all types of animal proteins used in animal feeds affords the possibility of using
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the bones present as a marker to indicate the presence of animal proteins in finished animal feeds. The policy of ‘zero tolerance’ in respect of the presence of MBM in animal feeds adopted in the wake of the BSE epidemics meant that effectively if just one ‘terrestrial’ animal bone was found in the sample of feed, then it was deemed to be contaminated with MBM. This very simplistic approach was probably the most practical way forward at the time, but the zero tolerance soon led to several different and unforeseen consequences (details on the methodologies applied in the detection of animal by-products are presented in Chapter 6).
24.6.2 Current EU status and initiatives Details of the EU TSE regulation may change according to the procedures laid down in the EU legislation. This approach involves all of the EU 27 Member States, in the form of the Standing Committee on the Foodchain and Animal Health (SCoFCAH), approving proposed amendments. Any of the recent amendments are almost certain to have been subject to risk assessment beforehand. Therefore, any successful amendment to what is a very strictly limited list of approved animal feed ingredients, will have been subjected to a three-tier level of approval, i.e. EFSA, the Commission, the Member States. What is more, the European Parliament also has a right of scrutiny and interjection if it so wishes. Table 24.3 summarises the materials that are currently (2010) prohibited and authorised in animal feeds in the EU. There have been and continue to be a range of initiatives in play in Europe to try to achieve the goal of more approvals for processed animal proteins. In the EU there are several layers of regulatory controls in place that form an overarching approach to controlling the safety of animal feeds. The key tool is the official method for detection of bone particles in animal feeds. This method was adopted in the very early days of the (animal) feed ban and in principle was a method of detecting meat and bone meal (MBM) in compound animal feed. It is important to note that the method is validated in respect of terrestrial bones and is able to differentiate land animal bones from fish bones. This is important, as fish meal (also a processed animal protein according to the ABPR) was not banned for use in pig and poultry feeds. One of these consequences was that even feathermeal was prohibited as it too contains (poultry) bones and this could not be differentiated from any other bones that might have been present if MBM was included in the animal feed. On the other hand, vegetable root crops such as sugar beet were found to contain mammalian bone fragments from time to time. This situation was certainly unforeseen and on investigation was found to be related to contamination in the growing fields from the bones of dead mice or birds. This latter finding did lead to a change in legislation: an aspect of tolerance linked to a risk assessment was introduced to achieve a pragmatic solution that did not stop beet harvesting if just one
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Table 24.3
Summary of EU feed legislation: prohibited and approved materials Prohibited Permanent ban
Ruminants
•
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•
Non-ruminant farm animals (pig and poultry)
Authorised
Temporary ban
Animal protein and feeding stuffs containing mammalian protein (PAPs, blood products, etc.) Feeding stuffs containing PAPs or DCP and TCP of animal origin
With restrictions
Completely
•
• • • •
• • •
Non-ruminant PAPs Proteins of ruminant origin (gelatine, blood, PAPs)
• • • •
Fish
Fishmeal for unweaned ruminants (from 2008, conditions of use)
• • •
Fishmeal (conditions of use) DCP and TCP (conditions of use) Non-ruminant blood products (conditions of use) Animal fats (of ruminant origin with special processing)
•
Non-ruminant blood meal and blood products (conditions of use) Fishmeal (conditions of use) DCP, TCP of animal origin (conditions of use)
•
• • • •
•
Milk, milk-based products and colostrum Eggs and egg products Animal fat Hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins, feathers and fish Gelatine from non-ruminants Milk, milk-based products and colostrum Eggs and egg products Animal fat Gelatine derived from non-ruminants Hydrolysed proteins derived from parts of non-ruminants and from ruminant hides and skins Milk, milk-based products and colostrum Eggs and egg products
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mammalian bone fragment was found in a consignment. Nonetheless, the issue of ‘tolerance’ has not yet been fully agreed either in respect of (cross) contamination of one animal protein in another PAP or in terms of speciespure PAP in finished or compound feeds. The approach of the European Commission with regard to risk in animal feed is based upon the avoidance of ‘ruminant protein’ (of any category 1, 2, 3) in any farmed animal feed, to avoid any chance of it being ingested by ruminants. Therefore many of the control tools concentrate on the detection of ruminant protein at low levels both in PAP and in animal feeds. The ‘tolerance’ level in each is expected to be different, and the proposals under consideration are discussed accordingly. On a more marketoriented note, EFPRA have decided to term the PAP made from pigs and poultry (both monogastric animals) monoPAP in order to differentiate it from other types of PAP, such as ruminant PAP (used in petfoods) and fishmeal (fishPAP). Several key initiatives have been taken to try to achieve the following objectives: • Differentiate Category 3 PAP from Category 1 or 2 protein meals using a marker. • Determine the risk (by risk assessment) of additional TSE cases in Europe by the cross-contamination of animal feeds with ruminant protein. • Develop a method for species detection suitable to detect ruminant proteins in non-ruminant PAPs, with appropriate tolerances. • Develop an enhanced system that delivers a secure supply of speciespure PAP: from the source of the Category 3 ABP to the delivery of the PAP to the feed mill and farm. • Establish a new official method in Europe for the detection of ruminant proteins in finished or compound feeds. • Work with all stakeholders in the ‘foodchain’ to develop a strategy that meets the objectives of all members. In practice, this work has progressed over the last five years with a range of projects and studies being completed by both industry and official laboratories. Importantly, in this period, the European Commission has established a central laboratory of expertise in the subject of animal proteins. The Community Reference Laboratory – Animal Proteins (CRL-AP) is based in Gembloux, Belgium, and has been involved since 2007 with many aspects of the animal protein work. Markers This work involving EFPRA and the EU Joint Research Centre (JRC) in Geel, Belgium, developed and validated a marker, glycerol triheptanoate (GTH), for addition to Category 1 and 2 processing plants.
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Risk assessment EFPRA commissioned an independent report on the potential risk from cross-contamination of ruminant protein by DNV, a worldwide risk assessment company. The model used was the same one used by the European Food Safety Authority (EFSA) when calculating the risk of crosscontamination by MBM in animal feeds. The EFPRA/DNV Risk Report results indicate that if there is a limit of detection as high as 5% ruminant protein in monoPAP (together with a limit of detection of 1% monoPAP in ruminant feed), and that these levels applied to all of the cattle feed produced in the EU, then the risk of additional BSE cases would be extremely low and significantly lower than the value reported in the EFSA’s ‘Opinion of the Scientific Panel on Biological Hazards on the quantitative risk assessment of the animal BSE risk posed by meat and bonemeal with respect to the residual BSE risk’ (EFSA, 2005). It is also noteworthy that the European Commission have updated the ‘TSE Roadmap’ and have published a TSE Roadmap 2 (2010) with a view to the possible adaptation of certain measures of the current feed ban. PAP species identification This work has been conducted by EFPRA/CCL in conjunction with the CRL-AP. The outcome has been a development of an ELISA-based method (MelisatekTM) that is able to detect 1% ruminant protein (processed up to 137°C under pressure) in a mixture with non-ruminant proteins at a sensitivity of 100%. LYNXX: a secure supply chain This system is still under development, but is considered to be important in bringing confidence into the supply of monoPAP for animal feeds. One of the main aspects of LYNXX is the requirement for segregation at all parts of the chain, beginning with slaughterhouses, then process (rendering) plants, and finally feed mills. Specific transport codes of practice will also apply at the appropriate stages. Official methods Development and validation of methods is the responsibility of the CRL-AP and the European Commission. Two major EU projects have assisted in this process: • EU R&D project ‘STRATFEED’: Objective to improve and if possible quantify official microscopy method for animal feeds and to develop other species detection methods. • EU R&D project ‘SAFEED-PAP’: Objective to continue developments above and to develop and validate a suitable method that enhances the official microscopy method.
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It now appears that a new official method may be validated within the next nine months or so. At least two PCR methods for detecting ruminant proteins in finished feed at a level of 0.1% are under consideration to be included in an inter-laboratory study (ring trial) to be completed in 2011. If successful, one or more PCR methods could be published as new ‘official EU methods’. Stakeholders EFPRA are members of a group bringing together different individual sector associations: farmers, red meat, poultry meat, meat processors and animal feeds. This group have come together to work on both the technical and political aspects of gaining the authorisation of monoPAP for use in animal feeds.
24.6.3 EU rapid alert In Europe there is a system in place termed the ‘Rapid Alert System for Food and Feed’. It has been established in response to ‘crises’ in the food chain that have occurred in the last decade. Apart from BSE (which as an epidemic would probably not have been prevented by such a system), the main initiator was the Belgian dioxin crisis. The rapid alert system is organised to try to prevent any future crises, and is operated effectively by national competent authorities that are required to notify the Commission of their own findings. As a result, the information is publicly available as soon as possible, so that all involved in the chain may be able to take some actions. Some examples appearing in the rapid alert reports are microbiological contamination, bone particles, chemical contaminants such as dioxin/PCBs or natural toxins (mycotoxins and others). None of these contaminants should, in principle, be present in quality feed products, but if mistakes occur and these contaminants do find their way past the first safety net, then this system can be regarded as a further safeguard.
24.6.4 Codex Alimentarius Globally, all feed regulation requirements should conform with the Codex Alimentarius Code of Practice on Good Animal Feeding (CAC/RCP 54-2004). This Codex Code has been converted to a Feed Manual, published jointly by FAO and IFIF: Good Practices for the Animal Feed Industry. Currently, there is still a worldwide ban on the use of ruminant proteins in ruminant feeds. This position, first proposed in UK and then in Europe, has become the norm for ruminants. However, in many parts of the world ruminants are allowed to be fed non-ruminant animal proteins and animal fats from all species, including ruminant-derived fat.
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As described in Section 24.4.2, Canada and the USA have enacted ‘enhanced feed bans’ based upon the removal of certain high-risk raw materials from the feed and food chain.
24.7 Future trends The European approach of ultra-precaution has been rigidly applied for about 10 years, so 2012 and 2013 are important years in Europe. There is high expectation that monoPAP will be authorised for aquafeeds in 2012 or 2013, and for pigs and poultry soon after. The demand for monoPAP is high, both inside and outside Europe, but as a prerequisite for export from Europe for use in animal feeds, the monoPAP must be legally saleable within the EU. Now with the technical solutions on the horizon and a high demand for the supply of animal-derived nutrients, the future for the European animal by-products sector looks promising.
24.8 References Codex Alimentarius: Code of Practice on Good Animal Feeding, CAC/RCP 54-2004, www.codexalimentarius.net Commission Regulation (EU) No. 142/2011 of 25 February 2011 implementing Regulation (EC) No. 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive, OJ, L54/1, 26 February 2011. EFIP benchmark standard and EFISC, www.efip-ingredients.org efsa, 2005, Opinion of the Scientific Panel on Biological Hazards on the quantitative risk assessment of the animal BSE risk posed by meat and bone meal with respect to the residual BSE risk, EFSA Journal, 257, 1–30. efsa, 2007, Opinion of the Scientific Panel on Biological Hazards on a request from the European Parliament on certain aspects related to the feeding of animal proteins to farm animals, EFSA Journal, 576, 1–41. IFIF/FAO Manual: Good Practices for the Animal Feed Industry, www.ifif.org meeker d l (ed.), 2006, Essential Rendering. Published by the National Renderers Association, the Fats and Proteins Research Foundation and the Animal Protein Producers Industry. ISBN 0-9654660-3-5. Regulation (EC) No. 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ, L147, 31 May 2001. Regulation (EC) No. 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption, OJ, L273, 10 October 2002. 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, L300/1, 14 November 2009.
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SAFEED-PAP: http://safeedpap.feedsafety.org STRATFEED: http://www.stratfeed.cra.wallonie.be taylor d m, woodgate s l, and atkinson m j, 1995, Inactivation of the bovine spongiform encephalopathy agent by rendering procedures, Vet Rec, 9 December 1995, 137, 605–610. taylor d m, woodgate s l, fleetwood a j, and cawthorne r j g, 1997, Effect of rendering procedures on the scrapie agent, Vet Rec, 20–27 December 1997, 141, 643–649. tse roadmap 2, (2010), http://ec.europa.eu/food/food/biosafety/tse_bse/docs/ roadmap_2_en.pdf woodgate s l, 1994, Rendering systems and BSE agent deactivation, Livestock Production Science, 38, 47–50. woodgate s l and van der veen j t, 2004, The role of fat processing and rendering in the European Union animal production industry, Biotechnol Agron Soc Environ, 8(4), 283–294.
24.9 Appendix: glossary of terms EU Food Regulations (853/2004) The EU Food Regulations (of which this is one of a series of five) lay down hygiene and processing conditions for certain edible co-products such as carcase fat and bones. EU Animal By-products Regulation (ABPR/1774 as amended) The EU Animal By-products Regulation 1774/2002 lays down health rules concerning animal by-products not intended for human consumption. EU Animal By-products Regulation (ABPR/1069) The EU Animal By-products Regulation 1069/2009 lays down health rules concerning animal by-products not intended for human consumption. EU Animal By-products Implementing Regulation (ABPR-IR/142) The EU Animal By-products Implementing Regulation 142/2011. EU TSE Regulation (999/2001 as amended) The EU TSE regulation (TSER) lays down specific details regarding removal of Specified Risk Materials (SRM) from bovines and ovines, and age limits for BSE testing. The TSER also contains a list of non-approved and approved derived products that may be used in feeds for farmed animals. Edible co-products Materials that are processed in accordance with the food regulations, from which derived products may be used in animal feed. The process used is termed melting or edible rendering.
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Category 3 animal by-products Category 3 animal by-products comprise exclusively animal by-products derived from approved animals. These approved animals are slaughtered in an approved slaughterhouse and are considered as fit for human consumption after an ante- and post-mortem veterinary inspection in accordance with the Community legislation. The process used is termed rendering. Derived products Products derived from processing of certain edible materials or animal byproducts in accordance with the EU Food, ABPR and TSE regulations. Rendered animal fats Animal fats derived from edible co-products or Category 3 animal byproducts by melting/rendering. Processed Animal Proteins (PAP) Animal proteins derived from edible co-products or Category 3 animal byproducts by melting/rendering. Approved products Blood products, gelatin, hydrolysed proteins and di-calcium phosphate are approved products in the ABPR/1774. However, the TSER/999 currently approves the above for use in animal feed and also approves the use of non-ruminant blood meal for use in aqua-feeds only. Feed ingredient Any derived product used in feed for animals farmed for food production. Animal feed Feed for animals farmed for food production, including terrestrial and aquatic animals. Petfood Feed for pet species normally nourished and kept as companions, but not consumed by humans. Fur animal feed Feed for farmed fox or mink species, not consumed by humans. STRATFEED An EU research project on ‘Strategies and methods to detect and quantify mammalian tissues in feedingstuffs’.
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SAFEED-PAP An EU project on ‘Species-specific detection of processed animal proteins in animal feed’. TSE Roadmap A Communication to the European Parliament and the Council which outlines areas where future possible changes to EU legislation on TSEs could be made.
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