Guidance on the assessment of the safety of feed additives for the environment
2019; Wiley; Volume: 17; Issue: 4 Linguagem: Inglês
10.2903/j.efsa.2019.5648
ISSN1831-4732
AutoresVasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Fašmon Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Theo C.M. Brock, Joop de Knecht, Boris Kolar, Patrick van Beelen, Laura Padovani, Jordi Tarrés‐Call, Maria Vittoria Vettori, Giovanna Azimonti,
Tópico(s)Pesticide Exposure and Toxicity
ResumoEFSA JournalVolume 17, Issue 4 e05648 Scientific OpinionOpen Access Guidance on the assessment of the safety of feed additives for the environment EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel), EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel)Search for more papers by this authorVasileios Bampidis, Vasileios BampidisSearch for more papers by this authorMaria Bastos, Maria BastosSearch for more papers by this authorHenrik Christensen, Henrik ChristensenSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorMaryline Kouba, Maryline KoubaSearch for more papers by this authorMojca Kos Durjava, Mojca Kos DurjavaSearch for more papers by this authorMarta López-Alonso, Marta López-AlonsoSearch for more papers by this authorSecundino López Puente, Secundino López PuenteSearch for more papers by this authorFrancesca Marcon, Francesca MarconSearch for more papers by this authorBaltasar Mayo, Baltasar MayoSearch for more papers by this authorAlena Pechová, Alena PechováSearch for more papers by this authorMariana Petkova, Mariana PetkovaSearch for more papers by this authorFernando Ramos, Fernando RamosSearch for more papers by this authorYolanda Sanz, Yolanda SanzSearch for more papers by this authorRoberto Edoardo Villa, Roberto Edoardo VillaSearch for more papers by this authorRuud Woutersen, Ruud WoutersenSearch for more papers by this authorTheo Brock, Theo BrockSearch for more papers by this authorJoop de Knecht, Joop de KnechtSearch for more papers by this authorBoris Kolar, Boris KolarSearch for more papers by this authorPatrick van Beelen, Patrick van BeelenSearch for more papers by this authorLaura Padovani, Laura PadovaniSearch for more papers by this authorJordi Tarrés-Call, Jordi Tarrés-CallSearch for more papers by this authorMaria Vittoria Vettori, Maria Vittoria VettoriSearch for more papers by this authorGiovanna Azimonti, Giovanna AzimontiSearch for more papers by this author EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel), EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel)Search for more papers by this authorVasileios Bampidis, Vasileios BampidisSearch for more papers by this authorMaria Bastos, Maria BastosSearch for more papers by this authorHenrik Christensen, Henrik ChristensenSearch for more papers by this authorBirgit Dusemund, Birgit DusemundSearch for more papers by this authorMaryline Kouba, Maryline KoubaSearch for more papers by this authorMojca Kos Durjava, Mojca Kos DurjavaSearch for more papers by this authorMarta López-Alonso, Marta López-AlonsoSearch for more papers by this authorSecundino López Puente, Secundino López PuenteSearch for more papers by this authorFrancesca Marcon, Francesca MarconSearch for more papers by this authorBaltasar Mayo, Baltasar MayoSearch for more papers by this authorAlena Pechová, Alena PechováSearch for more papers by this authorMariana Petkova, Mariana PetkovaSearch for more papers by this authorFernando Ramos, Fernando RamosSearch for more papers by this authorYolanda Sanz, Yolanda SanzSearch for more papers by this authorRoberto Edoardo Villa, Roberto Edoardo VillaSearch for more papers by this authorRuud Woutersen, Ruud WoutersenSearch for more papers by this authorTheo Brock, Theo BrockSearch for more papers by this authorJoop de Knecht, Joop de KnechtSearch for more papers by this authorBoris Kolar, Boris KolarSearch for more papers by this authorPatrick van Beelen, Patrick van BeelenSearch for more papers by this authorLaura Padovani, Laura PadovaniSearch for more papers by this authorJordi Tarrés-Call, Jordi Tarrés-CallSearch for more papers by this authorMaria Vittoria Vettori, Maria Vittoria VettoriSearch for more papers by this authorGiovanna Azimonti, Giovanna AzimontiSearch for more papers by this author First published: 05 April 2019 https://doi.org/10.2903/j.efsa.2019.5648Citations: 125 Correspondence: feedap@efsa.europa.eu Requestor: European Food Safety Authority Question number: EFSA-Q-2016-00400 Panel members: Giovanna Azimonti, Vasileios Bampidis, Maria Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen. Acknowledgements: The EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) wishes to thank the following for the support provided to this scientific output: Gerhard Flachowsky, Boet Glandorf, Jürgen Groop, Lieve Herman, Guido Rychen, Maria Saarela, Maria Arena, Antonio Luís González Sánchez, Lucilla Gregoretti, Paola Manini. Adopted: 27 February 2019 This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1595/full AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. Draft endorsed by the FEEDAP Panel 2 October 2018 Submitted for public consultation 8 October 2018 End of public consultation 19 November 2018 Adoption by the FEEDAP Panel 27 February 2019 Implementation date 1 September 2019 Background and Terms of Reference Regulation (EC) No 1831/2003 establishes the rules governing the Community authorisation of additives for use in animal nutrition. Moreover, Regulation (EC) No 429/2008 provides detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) has adopted a series of guidance documents which aim at complementing Regulation (EC) No 429/2008 to support applicants in the preparation and submission of technical dossiers for the authorisation of additives for use in animal nutrition according to Regulation (EC) No 1831/2003. The European Food Safety Authority (EFSA) asked its FEEDAP Panel to: identify from the current guidance documents, those that need to be updated, taking into consideration the most recent scientific developments and the experience gained in the assessment of feed additives; update the guidance documents in need of revision accordingly; this activity can be conducted in different rounds on the basis of the priorities identified and on the feasibility of the revision according the resources available; taking into account the sensitivity and the relevance of some of the guidance documents under revision and the entity of the revision itself (e.g. substantial or not), consider initiatives like preparatory info-sessions or public consultations of the draft guidance documents. The relevant comments received in either step will have to be considered and addressed if appropriate in the final version of the guidance documents. The first of the terms of reference was addressed by a statement of the FEEDAP Panel (EFSA FEEDAP Panel, 2016), in which it was identified the need to update most of the guidance documents that it produced and set priorities for this update. This output addresses the second and third terms of reference with regard to the update of the guidance documents dealing with the assessment of the environmental risk of feed additives. Scope of the guidance This guidance document is intended to assist the applicant in the preparation and the presentation of its application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003. This document does not substitute for the obligation of an applicant to comply with the requirements of Regulation (EC) No 1831/2003 and its implementing rules. This guidance document is intended to provide the information necessary to properly assess the environmental impact of a feed additive, in order to demonstrate compliance with the requirements of Article 5.3 of Regulation (EC) No 1831/2003. Applicants should justify the omission from the dossier of any data or any deviations from the requirements detailed in this guidance. A feed additive may be a well characterised chemical or agent (e.g. a crystallised amino acid of > 98% active substance); a mixture of active chemicals or agents each of which is clearly definable (qualitatively and quantitatively); or a complex mixture in which not all constituents can be identified (typically plant extracts, containing several different chemically defined and/or undefined compounds). Different risk assessment procedures are considered. When the additive contains one or more clearly definable chemicals or agents, the ERA described in this guidance should be performed for each chemical/agent. For complex mixtures with unidentified constituents, the FEEDAP Panel notes that developing an environmental risk assessment for such mixtures is not in the scope of the present guidance. The EFSA Scientific Committee is currently developing a guidance to assess mixtures of chemicals. Once the Scientific Committee of EFSA has officially published their guidance on risk assessment for mixtures, the FEEDAP Panel will consider it in a future update of this guidance. For additives falling under the scope of Regulation (EC) No 1829/20031, the requirements for GMOs should be fulfilled. When assessing the impact of microorganisms used as active agents as feed additives (i.e. feed additives containing viable microorganisms) to the environment, the following scenarios may apply: For microorganisms included in the QPS list, any impact on the environment is assessed in the framework of the qualified presumption of safety (QPS) evaluation (EFSA BIOHAZ Panel, 2017). When the identity of such a microorganism included in the QPS list is unequivocally established and any qualification (if existing) is met, safety for the environment is presumed. Strains carrying acquired genes for antimicrobial resistance are presumed to pose a risk for human and animal health via the environment. For microorganisms not included in the QPS list the following applies: – For those naturally present in soils, plants or gastrointestinal tract of animals, their use as a feed additive is considered unlikely to introduce disturbances in the microenvironment where they are already prevalent. Consequently, the Panel considers that their use as feed additives would not pose a risk for the environment. – For those not naturally present in soils, plants or gastrointestinal tract of the animals, a case-by-case assessment would be needed. The principles of an OECD Guidance to the environmental safety evaluation of microbial biocontrol agents (SANCO/12117/2012 –rev. 0) (SANCO, 2012) or the principles of the EFSA guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (EFSA GMO Panel, 2011) may be used as a guide. Furthermore, the European Commission is currently developing a guidance document on the risk assessment of metabolites produced by microorganism after application as active substances in plant protection products. Such guidance document can be considered in a future update of this guidance. This guidance is divided in four sections. The introduction provides the principles of the environmental risk assessment (ERA) for feed additives. A Phase I decision tree is provided in Section 2, including the predicted environmental concentrations (PECs) for feed additives for terrestrial and aquatic environments. The PEC formulas and related default values were derived from the European Medicines Agency (EMA) guidance for the environmental risk assessment of veterinary medical products. The Phase II assessment, containing information on determination of predicted no effect concentrations (PNECs), on refinement of PECs and refinement of PNECs is given in Section 3. Section 3 includes also the assessment of persistent, bioaccumulative and toxic (PBT) substances and the assessment for secondary poisoning. Section 4 describes how to provide information on studies retrieved from the literature. 1 Introduction This document provides guidance on how to conduct and report studies concerning the assessment of the safety of feed additives for the environment. It is an update of the previous one (EFSA, 2008a) and supersedes it. Consideration of the environmental impact of feed additives is important since administration of these substances typically occurs over long periods, often involves large groups of livestock animals and the constitutive active substance(s) may be excreted to a considerable extent either as the parent compound or its metabolites. Regulation (EC) No 1831/2003 and its implementing rules (Regulation (EC) No 429/2008) describe that an environmental risk assessment (ERA) should be conducted for (1) terrestrial compartment (via spreading of animal manure contaminated with feed additives on agricultural soils), (2) the aquatic compartment (via drainage and run-off from agricultural fields to surface water, via direct discharge of waste water from land-based fish farms to surface water, or via excreta from fish farmed in cages to sediment), and (3) the groundwater compartment (via leaching from soil). As referring to the air compartment, according to ECHA (2008b), 'methods for the determination of effects of chemicals on species arising from atmospheric contamination have not yet been fully developed, except for inhalation studies with mammals. Therefore, the methodology used for hazard assessment (and therefore the risk characterisation) of chemicals in water and soil cannot be applied yet in the same manner to the atmosphere'. The ERA decision schemes described in this document aim to protect non-target plant and animal species in the receiving environment at the population level, while the protection level for microbes and protozoans is set at the biological functional group level.2 As default the 'ecological threshold option' (see Appendix A) is selected as specific protection goal (SPG). In this option, the magnitude of tolerable effect on key organism groups in the receiving environment is set at small (e.g. < 10% effect relative to controls). The ERA for feed additives (and their metabolites) is based on the precautionary principle meaning that, in the absence of relevant and reliable data, the PEC and PNEC estimates are based on worst-case assumptions, which could be refined by generating more relevant and reliable data. To determine the environmental impact of feed additives, a stepwise approach is followed. All feed additives should be assessed through Phase I to identify those feed additives which do not need further testing. For the other feed additives, a second phase (Phase II) assessment is needed. Additional information has to be provided, based upon which further studies may be considered necessary. Some feed additives that might otherwise stop in Phase I may require additional environmental information to address particular concerns associated with their potential risk. These situations are expected to be the exception rather than the rule and some evidence in support of the concern should be available. The option of post marketing monitoring should be considered in the case that the negative effects of feed additive on the environment could not be undoubtedly excluded. For the purpose of this guidance, the following definitions apply: – Active substance: any substance or mixture of substances intended to be used as/in a feed additive that provides the intended effect.3 – Active agent: any microorganism intended to be used as/in a feed additive and that provides the intended effect. – Feed additive: substances, microorganisms or preparations other than feed materials and premixtures which are intentionally added to feed or water in order to perform one or more functions mentioned in Article 5.2 of Regulation (EC) No 1831/2003. 2 Phase I assessment The purpose of Phase I assessment is to determine if a significant environmental effect of the additive is likely and whether a Phase II assessment is necessary. Phase I is based on a list of exclusion criteria structured in a decision tree. By using a minimum set of information, it is aimed to screen additives that do not need a Phase II ERA. The ERA of major species can be extrapolated to minor species when the same conditions of use are proposed. Exemption from Phase II assessment may be made on the following criteria, unless there is scientifically based evidence for concern: The additive is intended for non-food producing animals only; The additive is a natural substance, or made of natural substances, the use of which as a feed additive would not exceed its natural occurring concentrations in feed sources, and/or would not substantially alter the concentration and/or distribution of the substance in the receiving environment; The additive is extensively metabolised in the target animal; The feed additive is not a potential persistent, bioaccumulative and toxic (PBT) or/and very persistent and very bioaccumulative (vPvB) substance; The additive does not trigger concern due to a specific mode of action or due to accumulation in the receiving environment over the years; and The PEC for each compartment of concern, calculated based on (i) the annual input of the manure, and (ii) the assumption that 100% of the dose ingested is excreted as the parent substance, does not meet the threshold value that triggers a Phase II assessment. A decision tree is presented below (see Figure 1: Quick check), with explanatory notes for each question in Sections 2.1-2.1, 2.1, 2.1, 2.1–2.7. Figure 1Open in figure viewerPowerPoint Quick-check – Environmental Risk Assessment: Phase I *PEC in ground water is set equal to PEC in pore water (see Section 2.6.2). Further clarifications on these questions are given in the following subsections 2.1 Question 1: Is the feed additive intended for non-food producing animals only? Generally, non-food producing animals are not intensively reared and/or their excrements are not spread over agricultural land. Therefore, due to the limited total amount of product used, feed additives for non-food animals are expected to produce less environmental concern than the feed additives in food-producing animals. As a consequence, besides exceptional cases (e.g. additives used in intensively reared fur-producing animals), no further assessment is required (Figure 1). For those exceptional cases, the ERA would proceed through the following questions. 2.2 Question 2: Is the feed additive a (made up of) natural substance(s), the use of which would not exceed its natural occurring concentrations in feed sources and/or would not significantly alter the concentration and/or distribution of the substance in the receiving environment? Evidence should be provided showing that comparable concentrations of the feed additive can be expected in other plant(s) and/or that the use of the feed additive will not significantly alter the concentration of the additive in the receiving environmental compartments of concern. For this purpose, the excretion rates (as active substance) in target species exposed to the additive at the highest permitted level in the EU or at the highest intended concentration in feed, should be compared with the lower ranges of reported background concentrations in soils, water and plants. If applicable, its degradability in the receiving environment may also be considered. Evidence on which to base such scientific rationale should be provided. This evidence can be based on available information retrieved from structured literature reviews and/or on analytical data (see Section 4). For instance, if the concentration of a colouring agent used in fish feed is similar to that encountered in the natural diet of the fish species of concern (see EFSA FEEDAP Panel, 2014), or the concentration of a flavouring compound in feed does not exceed its natural concentration in plants (see EFSA FEEDAP Panel, 2016), no adverse impact is expected for the environment. 2.3 Question 3: Is the feed additive extensively metabolised in the target animal or rapidly and completely degraded in manure? A feed additive is considered to be 'extensively metabolised' if converted into metabolites present in the excreta that do not possess a biological activity of environmental concern, like water, CO2 and common salts. A similar approach as in EMA, 2016 is followed: As a part of the Phase I assessment, data (analytical and/or from the scientific literature, see Section 4) on degradation of the active residue in manure may be submitted. If the active residue is rapidly and completely degraded in manure then the assessment may end at Phase I. In order to fully satisfy the requirements and to be in compliance with the definition of extensive metabolism, complete degradation should be demonstrated either by total mineralisation or by the presence of degradation products all representing ≤ 5% of the initial concentration in feed. When the application covers several target species/categories, it is recognised that it may be very demanding to provide studies for all potential target species receiving the feed additive. Therefore, interspecies extrapolation of data can be applied. The applicant is referred to the guidance on the assessment of the safety of feed additives for the consumer, in its Section 2.1.1.1, to select the most representative species to be investigated.4 2.4 Question 4: Is the feed additive a potential persistent, bioaccumulative and toxic substance or/and a very persistent and very bioaccumulative substance? Substances that are PBT or vPvB are of very high concern (REACH Regulation (EC) No. 1907/2006 and subsequent amendments).5 Due to the combination of these intrinsic properties and possible redistribution across environmental compartments, they pose serious hazards to non-target organisms. Substances are considered as PBT or vPvB substances when they fulfil the criteria as laid down in Annex XIII of the REACH Regulation (EC) No 1907/2006 (and subsequent amendments),6 for all three inherent properties P, B and T or both of the inherent properties vP and vB, respectively. To ensure a harmonised approach, these criteria together with the methodology in the current REACH guidance on PBT assessment (ECHA, 2017a,b,c,d) and the guideline on the assessment of PBT or vPvB substances in veterinary medicinal products (EMA, 2015), should be considered. If based on the available information or screening information the active substance is a (potential) PBT and/or vPvB substance, a separate PBT/vPvB assessment in phase II needs to be conducted. Where only screening information is available for one or more endpoints, the first step consists in screening whether the substance may fulfil the criteria. Screening information listed in Appendix E can be used as a help for comparing the screening information with screening thresholds (screening criteria) established for this purpose (for further details, see ECHA Guidance Chapter 11 on PBT/vPvB assessment (ECHA, 2017a) and ECHA Guidance on information requirements and chemical safety assessment Part C (ECHA, 2017e), Section C.4.1). If for one or more endpoints the technical dossier contains only the information as required in Phase I, the applicant (based on screening information and other information available) must: – either derive an unequivocal conclusion that the substance does not fulfil the criteria; or – when this is not possible and there are indications that the substance may fulfil the criteria, the applicant must obtain further information needed to fulfil the objective of the PBT and vPvB assessment. The applicant should explain why the models they have used are appropriate for the substance in question. A decision scheme for assessing PBT or vPvB properties of the feed additive is presented in Figure 2. Figure 2Open in figure viewerPowerPoint Decision scheme for assessing PBT or vPvB properties of the feed additive 2.5 Question 5: Has the feed additive a specific mode of action of concern or may it potentially accumulate in soil due to multiyear application? Coccidiostats and histomonostats are chemicals with a specific toxic mode-of-action against harmful protozoa. Currently, they are authorised as feed additives in poultry and rabbit feed and, consequently, may be toxic to non-target organisms in environments that receive poultry/rabbit manure. A Phase II ERA is expected for these feed additives (see Section 3). Other substances, on the basis of toxicological studies on laboratory animals or other evidence, may show toxicological properties in vivo that are of potential concern for environmental biota at sublethal concentrations, e.g. reproductive toxicity. Substances that hardly dissipate in the environment of concern may accumulate in the receiving compartment(s), which can only be properly assessed when information on long-term fate is available. Therefore, when there is already evidence (either experimental or by screening) that a feed additive is not degradable and hardly dissipates, e.g. metals or other chemical elements that are excreted at amounts that can significantly increase the concentration in environmental compartments (see Question 2), these substances have to be assessed in Phase II. 2.6 Question 6a: Is the predicted environmental concentration of the feed additive used in terrestrial livestock species below a trigger value? When excreta from livestock are applied on land, the use of feed additives can lead to contamination of soil, ground water and surface water (via drainage and run-off). The PECs used in Phase I would arise considering all excreted compounds being spread on land and other specified assumptions (see Sections 2.6.1 and 2.6.2) which reflect in summary worst-case conditions. If PEC for soil (PECsoil) (default: 5 cm depth) is less than 10 μg/kg dry weight; and PEC for pore water (PECpw, surrogate for PECgw) (default: 20 cm soil depth) is less than 0.1 μg/L, the substance is considered not to pose a risk for the environment, and therefore, no further assessment is necessary, unless there is available scientific evidence that it could represent a risk for human health and/or the environment. 2.6.1 Calculation of PEC in soil (PECsoil) The amount of manure/slurry containing the feed additives allowed to be spread on land depends on the nitrogen content of the manure and the annual nitrogen load. Based on the data on feed intake and nitrogen content in manure, the maximum amount of parent compound per kg nitrogen excreted can be calculated by multiplying the concentration of the additive in feed with the feed consumption and dividing it by the corresponding nitrogen excretion. In Table 1, the feed intake and corresponding nitrogen excretion is given for the more relevant food-producing species/categories. Other data can be used if justified. For a worst-case estimation of the concentration in soil, the following assumptions are made: The additive is continuously applied at the maximal recommended dose (as proposed by the applicant) to the feed of the target animal; Total intake of the active substance is considered to be excreted as parent compound; The current annual nitrogen load standard for slurry/manure spread on farm/livestock unit in nitrogen vulnerable areas is 170 kg N/ha per year (EU nitrate directive 91/676/EEC). The annual nitrogen emission standard is an average value that might be applied on a farm per year. According to the code of good agricultural practices, the emission to particular non-vulnerable fields with crops/grass could exceed this value. It is recognised that in current agricultural practice in EU this average value could be exceeded and a different value could be considered (See Appendix G – aimed to support the refinement of the ERA at Member States level when a concern exists on use of higher amount of manure on soil); There is no dissipation of the parent compound during storage and spreading of slurry/manure; The standard assumption, when slurry/manure is spread on land, is that the additive is mixed in the soil up to 5 cm depth.7 Table 1. Default values for feed intake and nitrogen excretion (see in Appendix H the assumptions made in the different calculations) Animals Body weight start-end (kg) Productive cycles/yeara Feed intake (kg/animal place per year)b Nitrogen excreted (kg/animal place per year) Piglet 7–30 7.4 296 4 Pig for fattening 30–115 3.2 800 9 Sow with piglets 200 2.4 1,140 23 Cattle for fattening 250–630 1.2 4050 54 Veal calf 45–250 1.5 730 11 Dairy cowc 650 0.92 6,584 125 Lamb for fattening 4–32 1.5g 273 5 Sheep for fattening 15–55 1.5g 267 5 Meat sheep 60 1 607 10 Dairy sheep 60 1 580 10 Dairy goat 50 1 714 16.4
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