Proceedings of the Second NAHWOA Workshop

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EU Regulation 1804/1999 - the implications of limiting allopathic treatment

 Ray Keatinge1, Doug Gray2, Stig Milan Thamsborg3, Andrea Martini4, Peter Plate5

1 ADAS Redesdale, Rochester, Otterburn, Newcastle upon Tyne, NE19 1SB, UK ( Tel. ++1830 520608, Fax ++ 1830 520491, E-mail Ray.Keatinge@adas.co.uk )
2 Scottish Agricultural College, Veterinary Sciences and Animal Biology Division, Mill of Craibstone, Aberdeen UK
3 Royal Veterinary and Agricultural University, Gronnegaardsvej 2,1870 Fredriksberg C, Denmark.
4Dipartimento di Scienze Zootecniche dell’Universita di Firenze, Via della Cascine, 5-50144, Firenze, Italy.
5 Damory Veterinary Clinic, Edward Street, Blandford Forum , Dorset, UK.

 

Introduction

EU Regulation (1804/1999) covering the production of organic livestock will come into effect in August 2000. The regulation reinforces the requirement for a preventive, management approach to disease control in organic livestock. However with certain provisos, it also introduces a restriction on the number of ‘allopathic’ treatments that may be given before an animal loses its organic status. Concerns have been raised about the potential impact of this limitation on the practice and perception of organic farming. Handled in the wrong way, there could be adverse effects on animal welfare (if treatments are withheld), consumer confidence (if welfare is compromised) or consumer protection (if the result is under-recording or mis-recording of veterinary usage). The objective of this paper was to consider the likely implications for health and welfare, and to develop proposals for a more clearly defined framework for the interpretation of the regulation at farm level.

Member states will be required to interpret the regulation with reference to national circumstances, including the option to adopt tighter standards if appropriate. The detail of this interpretation will have a critical impact on how the regulation is implemented. To assess the potential effects of limiting veterinary treatment, the restriction must be considered in the wider context.

 

The role of management

The goal of underpinning health and welfare with husbandry and good management practice is well established (Boehncke, 1997). The extent to which these are effective in eliminating the need for further veterinary intervention will depend on the level of disease challenge (production system, stocking density, biosecurity, season), the resistance of the stock (conditions of management, nutrition, breed, selection within breed, concurrent disease), the existence of suitable management approaches (biology/epidemiology of the disease or infection) and the effectiveness of implementation (farm structure, managerial ability, economic pressures). Situations will inevitably arise (Baars, 1998) where the disease challenge is too great, or current knowledge too limited, to alleviate the occurrence (chronic or sporadic) of disease by management alone. The greatest challenges are likely on specialist organic units, with limited enterprise mix, and where stocking rates are approaching the limits for an organic system. These limits may be further tested by the wave of new converts to organic farming whose primary motivation, initially, is commercial rather than philosophical (Hayton, 1999).

 

Prevention rather than cure

The new regulation prohibits the use of chemically synthesised allopathic products for 'preventive' treatments. Current policy on strategic or preventive treatment varies between member states. Where permitted, these are restricted practices, used in specific circumstances and as part of an agreed disease reduction plan. In France, strategic or prophylactic treatment is not permitted. In Sweden, the banning of preventive treatment has led to significant problems of parasitic gastro-enteritis in young ruminants (Lund, pers. comm.), and other diseases endemic to areas of the country. While acceptable alternatives may be available for individual treatment, the size and range of the production unit on which the animals are managed could mean that relying on the identification and treatment of individuals poses an unacceptable risk to the welfare of the population as a whole: e.g. blowfly control in extensively managed UK sheep.

The indiscriminate use of allopathic products in a blanket preventive fashion offends the values of organic farming. However, there may be a case for distinguishing ‘preventive’ (i.e. supplanting management), ‘prophylactic’ (i.e. treatment in advance of symptomatic disease’), ‘metaphylactic’ (i.e. ‘to control the spread of disease’), and 'pre-emptive' (when used according to best clinical practice). This option is less clear-cut, requires value judgement, and may set undesirable precedents, but it is one alternative framework.

The regulation does not emphasise sufficiently requirements for an agreed formal health plan. These have got the potential to provide visible demonstration of acceptable health programmes, which allow management and alternative veterinary approaches to evolve on a farm by farm basis. To further improve health status, there is also considerable scope for organic producers to participate in various voluntary national health schemes.

 

Emphasis on alternative treatments

Where disease occurs, the promotion of phytotherapeutic or homeopathic approaches in preference to ‘proven conventional treatments’ has raised widespread concern. The decision to use alternative medicine must be on the basis of a therapeutic effect, appropriate to the condition and the target species. Homeopathy has a developing role in replacing the need for more conventional therapies (Anon, 1997; Aukland, 1999). However, the dearth of information on alternative veterinary treatments is well recognised (Baars and Lampkin, 1998). Many conventional practitioners feel exposed by the lack of information and of the cushion of familiar conventional safety, efficacy, residue-testing procedures. In Sweden, the situation is exacerbated by the fact that vets are specifically prohibited from prescribing homeopathic treatments (Lund, pers. comm.) because these treatments are not seen as ‘based on science and reliable practice’. While currently outside the licensing system for conventional drugs, future EU legislation for the control of veterinary medicines which impacts on the use and availability of alternative remedies cannot be ruled out.

 

Definitions

The precise definition of ‘chemically synthesised allopathic treatment’ is not clear. The EU (Directive 92/74) defines homeopathic products as ‘products prepared from ... homeopathic stocks ... according to procedures described by the European (or similar) Pharmacopoeia’.

Allopathy - derived from ‘Allopathie’ (Hahnemann, 1755-1843) may be described as ‘orthodox medical practice; treatment of disease by drugs, whose effect on the body is opposite to that of the disease; distinguished from homeopathy’. Allopathic treatments are usually considered synonymous with registered veterinary pharmaceutical, or proprietary medicinal products. Some phytotherapeutic treatments could also be viewed as allopathic in their mode of action. In France (M. Bouilhol, pers. comm.), the use of vaccine is interpreted as allopathic intervention. The status of biological control has not yet been considered. The definition of ‘chemically-synthesised’ is clearer - but less so with some vaccines, and purified herbal products. For practical purposes, an alternative broad classification is proposed; Allopathic (i.e. ‘synthetic’); Phytotherapeutic (i.e. ‘natural’), Homeopathic, Immunological (i.e.’vaccines and antisera’) and Biological (i.e. biological control).

 

Limiting allopathic treatment

The limit on allopathic treatments causes greatest concern in Scandinavia, and in the UK where, to date, certifying authorities have deliberately avoided such restrictions, fearful of adverse effects on animal welfare and public perception. These restrictions are also recognised as difficult to police in practice. In the case of breeding stock, Italy currently allows two allopathic treatments annually. In France, this restriction also includes treatment for parasites. Both appear to be able to accommodate this ruling within their current regulations. The exception of vaccinations, treatments for parasites and any compulsory eradication schemes provides considerable latitude. A ‘course of treatment’ is generally regarded as the only measure necessary to restore an animal to health following a particular disease episode. Parasites could include all endo- and ecto-parasites, but exclude viruses and bacteria. For the most part it would appear that the restriction is intended to curtail antibiotic use. However, there are also implications for treatments for infertility, metabolic diseases and the use of painkillers.

According to the National Office of Animal Health (NOAH, pers. comm.), many vaccines now have 'biotechnology' in their background, if not in the active ingredient then in the excepients. Any future prohibition on ‘genetic engineering’ could rule out important existing or new vaccines for organic systems. In terms of the acceptability of ‘genetically modified’ veterinary products for organic systems, Certification Bodies might choose to take a different view of live vaccines.

 

Current allopathic usage

Quantitative data on veterinary usage in organic systems is scarce. Survey data also has its limitations. However, information is available from a number of sources (e.g. Roderick and Hovi, 1999; Krutzinna et al, 1996; Sciarra and Guntensperger, 1997; Bouilhol, 1997; Kintail, 1991; Gustafsson-Fahlback, 1996; Hamilton et al, 1999). Taken as a whole, the information indicates that within current standards the incidence of disease on organic farms is generally at acceptable levels, and at least in some specific circumstances, better than that on conventional farms. The data also indicates a significant use of allopathic medicine.

In organic dairy herds the main disease issues are mastitis, infertility and lameness. While the incidence of mastitis may be similar to conventional dairy herds (Enemark and Kjeldsen, 1999), the use of antibiotics is significantly lower (Hovi and Roderick, 1999). This is due to restricted availability of antibiotics, the prohibition on dry cow therapy and greater use of complementary treatments. In the UK, 21% of organic dairy producers used a vaccine for leptospirosis control (Roderick and Hovi 1999) while 29% vaccinated against lungworm. From the survey of Krutzinna et al (1996), 53% of treatments in organic dairy herds were conventional.

In pig and poultry systems, it can be expected that antibiotic use is substantially lower than in conventional systems. Despite the use of rotation, coccidiosis is a potential problem in broilers (Fisker, 1999), with mortality rates in a severe outbreak up to 30% or greater (Lund, pers comm.). Coccidiosis is less of a problem in laying hens (Lampkin, 1997) but future requirements for organically produced pullets could change the situation dramatically.

Roderick and Hovi (1999) found that 19% of organic sheep producers needed to de-worm regularly, 64% of farms use cryomazine alone or in combination for blowfly control, and 44% of sheep producers used a clostridial vaccine. Only one in eight French sheep producers surveyed (Bouilhol, 1997) did not use wormers in breeding stock. In Germany, 28% of herds used dewormer for young dairy stock (Krutzinna et al, 1996). Roderick and Hovi (1999) reported that 24% of in-wintered beef herds were treated for lice, usually with a pyrethroid preparation.

Statutory vaccination is required against rabies in France, and Aujeszky’s Disease in Italy. In the UK, compulsory treatment for sheep scab may soon have to be re-introduced.

Changing standards may force producers to change current practice. Disease issues will also continue to evolve. Integrated production systems may throw up fresh challenges - such as transmission of erysipelas from swine (Lund, pers. comm.). Some (NOAH, pers. comm.) even suggest that organic farming is enjoying a honeymoon period as regards animal health, with the additional benefit of a ‘cordon sanitaire’ from highly protected conventional stock.

 

Other related issues

Conventional drugs vary in mode of action, how they are metabolised, and how they are excreted from the body. Some products are specifically banned from organic systems by certification bodies such as UKROFS and Bioland. However, objective methods of evaluating the suitability of conventional drugs for organic systems, on the basis of consumer protection, animal welfare and environmental effect, are not well developed (Plate and Striezel, 1996).

Withdrawal periods after the use of allopathic treatments provide a mechanism to promote greater consumer confidence. Most countries impose extended withdrawal periods above the statutory minimum - up to 6 months for antibiotics under KRAV regulations. At the moment, there is little scientific basis for such extensions. In the UK, NOAH (pers. comm.) contend that this approach, taken alongside the promotion of ‘unproven’ alternative treatments, could constitute a legal contravention of existing EU licensing arrangements.

In general, it is likely that the use of veterinary medicines will become more controlled in the future, either through legislative means (Advisory Committee on the Microbiological Safety of Food, 1999; Young et al. 1999) or through voluntary codes (Responsible Use of Medicines in Agriculture Alliance, 1999).

In an attempt to ensure the distinction between organic and conventional systems, there may be a temptation to pursue even more restrictive veterinary practices. Early indications from the USA suggest that this could be a difficult route to follow.

 

Conclusions

The EU regulation seeks to strike a balance between the responsible use of veterinary inputs, the need to safeguard animal health and welfare, and the requirement to retain consumer confidence and consumer protection. After protracted negotiation, an agreement has been finally reached. The regulation is now available to be translated into national standards.

Depending on interpretation of the text, several views are possible:

The current tone appears to be more concerned with reassuring the consumer, particularly regarding the use of antibiotics. Some elements of regulation invite criticism, whether justified or not, by those keen to undermine the organic approach. This can only be diffused by having a structured, consistent, workable and transparent rationale for animal health and disease control on organic farms.

The requirement at all times to treat animals when necessary, is highlighted under existing production standards. It is important that this principle is retained and not overridden by any other considerations arising out of a restriction on allopathic treatments. With current knowledge, a degree of flexibility in the use of chemically synthesised allopathic medicines is required at least in the short to medium term. The exemption of vaccines, parasite control agents and compulsory treatments should be retained beyond the next review date. This degree of flexibility needs to be tempered with consideration of the need to further develop organic systems, which minimise veterinary intervention.

The integrity of the system, animal health status and consumer confidence could be further guaranteed if, within the EU regulation, there was specific emphasis on a formal health plan, approved and reviewed by the inspection authority, and where possible supported by epidemiological data. Relative to the planned health programme, analysis of comprehensive records detailing 1) the occurrence of disease, and 2) all treatments given, could provide a mechanism better to assess health and welfare status on a given organic farm.

Given the above considerations the limitation of allopathic treatments to three may be less problematic. However, a safer, more constructive and less inflexible approach would be to underwrite organic production systems with pre-planned preventive approaches, which would have benefits for the herd/flock as a whole rather than being too concerned with limiting treatments to specific individuals.

Application in the field would be greatly assisted by a clearer structure defining levels of acceptable veterinary intervention, and better classification of groups/individual veterinary products. There is a need to establish the type of information and safeguards required to support the use of alternative therapies by vets in the field, and to facilitate further R & D.

 

References:

Advisory Committee on the Microbiological Safety of Food (1999) . Report on Microbial Antibiotic Resistance in relation to Food Safety, The Stationery Office 1999.

Anon (1997). Soft Medicine beats Antibiotics. PIGS-Misset, Vol 13, No. 3.

Aukland, C. (1999) Minimal Drug Use in Organic Farming Systems. EFRC Bulletin, No 46, Dec 1999.

Baars, T. (1998) Future Systems in Organic Farming: Animal production, health and welfare. In: Proceedings of the Fourth ENOF Workshop, Edinburgh, 25 26 June 1998: pp 31 - 38.

Baars, T. and Lampkin, N. (1998) Specialized Livestock Systems - discussion group report. In: Proceedings of the Fourth ENOF Workshop, Edinburgh, 25 26 June 1998: pp 89 - 93.

Boehncke, E (1997). Preventive Strategies as a health resource for Organic Farming. In: Proceedings of the Third ENOF Workshop, Ancona, 5-6 June 1997: pp 25 - 35.

Bouilhol, M.(1997) Livestock farming systems and parasite risk for sheep in Organic Farming. In: Proceedings of the Third ENOF Workshop, Ancona, 5-6 June 1997: pp 149 - 157.

Enemark & Kjeldsen (1999) LK - meddelelse nr. 353, Landskontoret for Kvaeg (1999).

EU (1992) Council Directive 92/74/EEC of 22 September 1992 Official Journal L297, 13/10/1992 p. 0012 - 0015.

EU (1999) Council Directive 99/1804/1999, 19 July 1999 Official Journal L221/1, 19/8/1999.

Fisker, C. (1999) MSc Thesis, 1999, Copenhagen, 94pp.

Gustafsson - Fahlback, M. (1996) Djurmiljo och parasitforekomst I utegrishallning - inventering pa 12 gardar. Jordbruksinformation 5, Swedish Board of Agriculture.

Hayton, A.J.(1999) Dealing with the organic milk producer, Cattle Practice, Vol 7, Part 4, p383-387.

Hamilton, C., Hansson, Ingrid, Forslund, Kristina and Ekman, Torkel. (1999) Djurhalsan I ekologisk mjolkproduktion. In: Ekologisk djurproduktion, Svensk veterinartidning nr. 2, Supplement 29. Centraltryckeriet, Boras. pp. 25-29.

Hovi, M. and Roderick, S. (1999). Mastitis in organic dairy herds - results of a two year survey. Proceedings of a Soil Association Conference - Mastitis the organic perspective, Stoneleigh, 3 September, 1999.

Kintail (1991) A survey of organic livestock health and treatment. Kintail Land Research Foundation/SAC, September 1991.

Krutzinna, C., Boehncke, E. and Herrmann, H-J. (1996) Organic milk production in Germany. Biological Agriculture and Horticulture 13, 351 - 358.

Lampkin, N (1997) Organic Poultry Production, Final report to MAFF 1997. Welsh Institute of Rural Studies.

Plate, P. and Striezel, A. (1996) Regulation of veterinary drugs considering aspects of product quality, animal welfare and environmental effects. 11th International Scientific Conference of IFOAM, Copenhagen, 11-15 August 1996.

Responsible Use of Medicines in Agriculture alliance (1999). RUMA, June 1999.

Roderick, S and Hovi, M. (1999) Animal Health and Welfare in Organic Livestock Systems: Identification of constraints and priorities, MAFF Report (OFO171), April 1999, pp 65.

Sciarra, C., and Guntensperger, I. (1997) Research on organic dairy cattle in Switzerland. In: Proceedings of the Third ENOF Workshop, Ancona, 5-6 June 1997: pp 159 - 166.

Young, R., Cowe, A., Nunan, C., Harvey, J and Mason L, (1998) The Use and Misuse of Antibiotics in UK Agriculture Part Two: Antibiotic Resistance and Human Health. The Soil Association.

 

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