This unique and definitive reference on hormone abuse in food producing animals is for scientists, regulators and consumers. It contains the results of a meeting held in November 2006 to discuss the progress made by the Veterinary Medicines Directorate (VMD) supported programme on steroid abuse detection. When the "hormone ban" first arose in the EU, there were only 15 Member States. There are now 27 and some newer members lack the background knowledge of this issue. This book sets out to summarise the history and show the significant progress that has been, and continues to be, made in this area. It is the only comprehensive review of this subject available and contains input from leading researchers from around the world. The initial chapters provide valuable background information. For example, the chapter on toxicology and risk covers the controversies arising from the interpretation of the effects of artificial hormones in meat-producing animals. The book then goes on to deal with how the issue has been managed via national and international detection programmes. It finishes by covering the resulting cutting edge analytical science including current research using "omics"/ profiling for "natural hormones" and novel detection techniques such as IRMS. This book offers readers an insight into the risk management of an important food related issue and how current analytical analyses can assist evidence-based risk assessments. There is comprehensive coverage of all past and current issues relating to growth promoting hormone abuse in animals.
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Jack F. Kay is an Honorary Senior Research Fellow in the Department of Statistics and Modelling Science at the University of Strathclyde. His interests lie in the consideration of sampling criteria to veterinary drug surveillance issues. He also has a full time position with the Veterinary Medicines Directorate (VMD) in the UK and has recently been appointed an expert advisor to the UN Food and Agriculture Organisation. The work for VMD also includes membership of the Analytical Sub-Group of the Pesticides Residues Committee, a UK FSA expert group on antimicrobial testing of milk, and membership of the FAPAS Advisory Committee. He contributed to the European Commission Decision that established performance criteria for analytical laboratories undertaking analyses for veterinary drug residues. He is also an ISO trained technical assessor, an active member of the Codex Committee on Residues of Veterinary Drugs and co-chair of the ad hoc Working Group on Methods of Sampling and Analysis, CCRVDF. Dr Kay facilitated the establishment of the UK "mirror group" to the European Technology Platform for Global Animal Health and chairs the UK National Reference Laboratories discussions on issues arising in their residue surveillance programmes. He has also co-organised three international meetings on veterinary drug residue analyses and is currently preparing for the SaskVal meeting in 2011.
This unique and definitive reference on hormone abuse in food producing animals is for scientists, regulators and consumers. It contains the results of a meeting held in November 2006 to discuss the progress made by the Veterinary Medicines Directorate (VMD) supported programme on steroid abuse detection. When the "hormone ban" first arose in the EU, there were only 15 Member States. There are now 27 and some newer members lack the background knowledge of this issue. This book sets out to summarise the history and show the significant progress that has been, and continues to be, made in this area. It is the only comprehensive review of this subject available and contains input from leading researchers from around the world. The initial chapters provide valuable background information. For example, the chapter on toxicology and risk covers the controversies arising from the interpretation of the effects of artificial hormones in meat-producing animals. The book then goes on to deal with how the issue has been managed via national and international detection programmes. It finishes by covering the resulting cutting edge analytical science including current research using "omics"/ profiling for "natural hormones" and novel detection techniques such as IRMS. This book offers readers an insight into the risk management of an important food related issue and how current analytical analyses can assist evidence-based risk assessments. There is comprehensive coverage of all past and current issues relating to growth promoting hormone abuse in animals.
Chapter 1 The Use of Hormomally Active Substances in Veterinary and Zootechnical Uses – The Continuing Scientific and Regulatory Challenges Leonard S. Levy, 1,
Chapter 2 Presence and Metabolism of Endogenous Steroid Hormones in Meat-producing Animals James Scarth and Christine Akre, 48,
Chapter 3 Hormone Use for Growth Promotion and National Programmes for Regulation of Hormone Use in Food-producing Animals Jack F. Kay and James D. MacNeil, 97,
Chapter 4 Current Analytical Methods Used for the Detection of Contents Hormone Residues Matthew Sharman, Leen van Ginkel and James D. MacNeil, 129,
Chapter 5 Current Research into New Analytical Procedures Ed. Houghton, Phil Teale, Emmanuelle Bichon and Bruno Le Bizec, 171,
Subject Index, 210,
The Use of Hormomally Active Substances in Veterinary and Zootechnical Uses – The Continuing Scientific and Regulatory Challenges
LEONARD S. LEVY
Institute of Environment and Health, Cranfield University, Cranfield, Bedfordshire, MK43 OAL, U.K.
1.1 Introduction
"Those who cannot learn from history are doomed to repeat it."
(George Santayana, 1863–1952)
"What experience and history teach is this – that people and governments never have learned anything from history, or acted on principles."
(George Wilhelm Hegel, 1770–1831)
The scientific, regulatory and political debate surrounding the use or banning of hormones or hormone-like substances in the production of meat and meat products and for veterinary use is, for me, the quintessential example of the limitations of all three of these facets of risk assessment/management inputs in producing unequivocal answers. It is thus a salutary lesson to scientists, regulators and policy-makers, politicians and risk assessors to understand all strands of this tangled issue. Whether or not it helps us to make better decisions in the future, for this and other continuing debates in risk assessment, will depend on which of the two above apparently contradictory quotations regarding the utility in understanding the past you subscribe to.
1.1.1 Recent Historical Perspective
A range of hormonally active substances, such as diethylstilboestrol (DES), had been used for growth promotion in cattle and sheep since the early 1950s. This latter use is termed zootechnical as opposed to veterinary or therapeutic use. Concerns about a possible risk of cancer from residues of such substances had been expressed in the early 1970s and eventually the European Community (EC) introduced a ban on the use of DES in 1987 and, in addition, banned the use of all hormonally active substances as growth promoters in food-producing animals in 1988. A similar condition was placed on all countries, so-called "Third Countries", wishing to export meat from such animals to the EC.
The United States and Canada objected to this ban to the World Trade Organization (WTO). As a result, in 1997, the WTO Expert Panel found that the ban was not based on science – for example, on a risk assessment or on relevant international standards.
The European Commission appealed against this ruling. In February 1998, the Appellate Body upheld the WTO Expert Panel's view, in that they found that the ban had been imposed without credible evidence to indicate that there were health risks posed by eating hormone-treated meat. As a result, the European Commission was given 15 months to remove the ban or produce a risk assessment.
As a response to this ruling, in early 1998, the European Commission (EC) sponsored 17 research studies to help clarify the findings in the Appellate Body report. These covered toxicological and carcinogenicity aspects, residue analysis, potential abuse and control problems and environmental effects of hormone use.
At the end of 1998, the EC's Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) was asked to carry out an assessment of the risk to human health from the use of the six hormonally active substances, particularly from residues from bovine animals where such substances were administered for growth promotion. These substances were: 17β-oestradiol, testosterone, zeranol, progesterone, trenbolone acetate and melengestrol acetate. In April 1999, the SCVPH produced its first Opinion on the subject.
The SCVPH concluded that the risks from hormone-treated meat were "higher than previously thought". Further, it proposed that there was a significant body of scientific evidence suggesting that 17β-oestradiol should be considered a complete carcinogen. It also concluded, with different standards of evidence, that there were risks to consumers from the other five hormones examined.
Most importantly, the SCVPH concluded that no threshold concentrations could be defined for the hormones – this precluded the setting of Acceptable Daily Intakes (ADIs) or Maximum Residue Limits (MRLs). However, they were unable to estimate the extent of any risk.
In the UK, the then Minister of Agriculture, Fisheries and Food asked the Veterinary Products Committee (VPC) to assess the evidence in the SCVPH Opinion. The VPC is an independent scientific committee that has the remit to give scientific and veterinary advice on veterinary medicines and other products used for animal production and husbandry to the Veterinary Medicines Directorate (VMD). The VMD has statutory duties in relation to veterinary medicines and products in the UK. The VPC set up a Sub-Group to do this, which reported in October 1999. At the same time, the Safety Working Group of the Committee for Veterinary Medicinal Products (CVMP) – the European Commission's own organisation with responsibility for advising on the safety of veterinary medicines – also examined the SCVPH Opinion.
Following detailed deliberations, the VPC Sub-Group was unable to support the SCVPH's conclusion that the risks associated with eating hormone-treated meat "might be higher than previously thought". The Sub-Group also found that it had sufficient concerns about the scientific reasoning in a number of key areas, to throw serious doubt on the conclusions of the SCVPH. However, the Group identified a number of areas where additional expert evidence should be sought to add to the data and help prevent selective scientific conclusions being drawn in the future.
The CVMP also produced a report in 1999 in response to the SCVPH Opinion (EMEA/CVMP/885/99). The CVMP was unconvinced by the SCVPH data and arguments, and concluded that its (the CVMP's) previous recommendations with regard to the ADIs and MRLs of the five hormones examined were still applicable (17β-oestradiol, altrenogest, progesterone, flugesterone acetate and norgestomet). The CVMP also noted that its conclusions were practically the same as the FAO/WHO Joint Expert Committee on Contaminants and Food Additives.
The UK Government accepted the view of the VPC-that they were unable to support the conclusion of the SCVPH of a "higher risk than previously thought" from eating hormone-treated meat. The UK has, however, always fulfilled its obligations to enforce the EU ban and continues to do so.
In May 2000, the SCVPH produced a review of its Opinion after having examined the reports of both the VPC and CVMP. The SCVPH noted that these two...
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