I move: "That the Bill be now read a Second Time."
The fundamental aim of this Bill is to meet the demand for comprehensive and coherent legislation on animal remedies covering the entire spectrum from the point of manufacture to the sale for human consumption of produce derived from treated animals.
The issue of animal remedies has generated a certain amount of controversy and can be divided into three principal areas of concern. First, there is the industrial aspects whereby animal remedies are developed and placed on the market. Secondly, there is the producer who relies on safe, efficacious animal remedies to ensure the health of his stock so as to derive the optimum return for his investment and labour. Last but not least, there are the consumers who rightly demand that the animal produce which they purchase comes from healthy animals and is not contaminated or rendered less wholesome by the use of animal remedies.
The interests of each of these groups are equally important and any regulatory controls must recognise the legitimacy of their concerns and strike the right balance to ensure that no single group asserts its demands at the expense of another party. I do not suggest that there is any fundamental conflict or incompatibility between these parties; in fact, their interests are complementary. It is the function of the legislative system to ensure the necessary mechanisms are applied to ensure that the rights of all are respected.
To achieve this necessary balance a comprehesive approach must be adopted as consistent treatment is not facilitated by fragmented legislation. Our existing legislation has served us well. We enjoy a very high animal health status and our animal produce enjoys an enviable reputation for natural wholesomeness. In today's highly competitive food sector there is no room for complacency. As it is over 30 years since primary legislation was introduced in this area it is timely, in view of the rapid pace of change and development in the pharmaceutical and farming sectors, that the legislative position be reviewed and updated to lay the basis of regulation for the years ahead right into the third millennium.
I would not like to create the impression that there has been total legislative inactivity in this area. Throughout the eighties there has been a steady stream of secondary legislation arising from national initiatives and out of harmonisation measures adopted at EC level. It is important to recognise that the decision to ban hormones, both natural and synthetic, was taken in the mid eighties at Community level. This decision was taken because of growing consumer unease and a series of abuses in a number of member states. We have exercised very strict controls in the interest of farmer, industry and consumer over this period and only two major criticisms can be directed at our efforts. These are the fact that this legislation is fragmented over a number of different Acts and that responsibility is also divided between different Ministers. The situation has been referred to on more than one occasion as a legislative maze. The other aspect is one which has been raised on a number of occasions in this House. I speak, of course, of the low level of penalties applicable to serious offences. I fully share the sentiments of those who call for a punishment to fit the crime and feel that the Bill before us today will leave potential offenders in no doubt as to the Government's intention to deal severely with such activities.
Perhaps the most striking aspect in the development of the animal health industry over the years is the increasing consumer awareness of farming practices and concerns regarding the safety of substances administered in livestock production. Consumers quite correctly demand assurances regarding the safety of these substances and their correct usage. The pharmaceutical industry and the farming community have to respect these concerns if their industries are to prosper. There is little point producing any commodity no matter how economically if the consumer refuses to buy it. Equally the consumer must be educated that all animal remedies must satisfy strict criteria of safety, quality and efficacy before they are approved for placing on the market, that the responsible use of animal remedies improves the health and welfare of animals and consequently the quality of their produce. Healthy stock reduces farmers' overheads and so consumers share the benefit of more economic production.
It should also be acknowledged that the vast majority of farmers are quality conscious, respect the law and are interested in supplying a product in which the consumer will have confidence. As a final guarantee strict official controls are applied at slaughtering facilities and dairies to ensure the safety and quality of animal produce entering the food chain. A comprehensive testing regime is in place ranging from tests on live animals to samples taken at the point of slaughter. Much of this sampling is taken on the basis of suspicion. It is therefore possible by co-operation of all interests and the regulatory authorities to make the food chain a chain of quality.
Trade in animal produce has been greatly facilitated by the adoption of a comprehensive range of harmonised measures at EC level dealing with the criteria for approval of animal remedies, thereby ensuring that different demands cannot be used to create artificial barriers to trade. To complement these measures harmonised schemes for monitoring for correct usage have also been put in place.
Unfortunately a disturbing trend of using illegal substances for growth promotion in livestock production has emerged throughout Europe and, there is evidence to suggest, further afield as well. We in Ireland have not been immune and it is deplorable that an unrepresentative group of unscrupulous producers and dealers threaten the hard earned reputation and the viability of our livestock and meat industry. Particular attention has focused on the use of beta-agonists, commonly referred to as angel dust and hormonal substances. These developments have created a degree of consumer resistance to beef and other meat products and aroused a suspicion in regard to the use of animal remedies generally. Reports of usage in the national and international media are, to say the least, not good for our image as a producer of quality produce and undermine the basic elements of the marketing strategy for our food sector.
Live animal and meat exports are vital to the economy and contribute in excess of £1 billion annually in export earnings to the economy. While this is a vital contribution to the economy, I do not exaggerate when I say it is the lifeblood of the farming community. Good reputations are hard to earn and once lost almost impossible to regain. We cannot tolerate the activities of those persons who threaten the very existence of our livestock industry. I will not enter into debate as to whether those who supply or those who use are more to blame. It is sufficient to say that supply and demand cannot be separated as they are totally inter-dependent. Any person who supplies, uses or encourages the use of illegal substances must be treated with equal severity and this Bill provides the appropriate basis for that purpose.
Existing legislation relating to animal remedies is contained in the Therapeutic Substances Act, 1932, which deals with the regulation of animal remedies which have immunological properties, the Animal Remedies Act, 1956, which regulates the availability of animal remedies and the Poisons Act, 1961, which regulates the use of animal remedies which are deemed by regulations under that Act to be poisons.
Developments in immunology and biotechnology have long since surpassed the scope of the Therapeutic Substances Act and a new legal basis for dealing with this area is now necessary. The Animal Remedies Act and the Poisons Act have limitations in scope and more importantly provide for summary offences only, with the maximum fine under either Act being £100 and the Poisons Act having a provision for a prison sentence of six months. The greatest limitation in scope arises in relation to the powers of enforcement, adequate when regulating a law abiding sector, but totally inadequate for dealing with users or suppliers of illegal substances. There is the added complication of having to make two separate regulations when the availability and use of an animal remedy requires to be addressed.
Developments in veterinary medicine and biotechnology have led to a situation where strict controls are necessary on animal remedies and harmonised action in this respect has been provided for by a series of EC Directives. Because of the limitation in our domestic legislation to implement these measures the European Communities Act, 1972, has been utilised to provide the substantial powers of enforcement necessary to combat what, in many instances, amounts to serious criminal activity in relation to the supply and use of illegal substances. A series of very stringent legislative measures entitled the European Commmunties (Control of Veterinary Medicinal Products and Their Residues) Regulations 1988 to 1992, have therefore, been introduced to prohibit the manufacture, importation, sale, possession and use of illegal substances or the abuse of authorised substances. Despite this, the regulations lack effectiveness because the European Communities Act provides for summary offences only. This means that the maximum penalties which may be imposed are those applicable to summary jurisdiction, which in the context of profits to be gained from the illegal use of these substances are insufficient to have a substantial deterring effect.
As I mentioned earlier, this Bill will provide a single legislative basis for the regulation and control of all animal remedies and for the consolidation of existing legislation in this area, as well as providing for appropriate enforcement and sanctions. The wide ranging powers to regulate reflect the degree to which animal remedies are an integral part of livestock production. Because of the importance which attaches to the use of pharmaceutical products at EC level, provision is made that future Community legislation in this area should be transposed into national law under the provisions of this Bill. This is an important provision as it will enable future EC legislation to be transposed into domestic law independently of the European Communities Act, 1972, the use of which for implementing EC legislation has many advantages but also has weaknesses. I have already referred to the restrictions on the penalties which may be imposed under the European Communities Act.
The second consideration is the requirement that all measures regulated for in this manner must be necessitated by the parent instrument. Any measure introduced on this basis may be challenged on the basis that it might not be necessitated by the parent directive or decision. Implementation of EC instruments by means of regulations under this Bill will enable the incorporation of wider ranging incidental and supplemental provisions so as to make the enforcement of the legislation more effective and better suited to Irish conditions and practice. It also means that infringements of such provisions will attract the high penalties provided for in this Bill and will leave our EC partners in no doubt about our commitment to the application of harmonised rules.
The Bill in section 1 revises the definition of "animal remedy" so as to cover fully the scope of EC legislation on veterinary medicinal products and to keep abreast of technological developments.
Section 2 sets out the animals to which the Act will apply. The definition is greatly extended from the 1956 Act and includes all mammals, birds, fish molluscs and bees and any other animal kept, or whose produce is intended, for human consumption. This is necessary to take account of species not covered by the 1956 Act which are now being farmed or reared for human consumption, for example deer and fish. It is also desirable to provide that all remedies intended for any animal are covered, as otherwise unacceptable products could be marketed for species outside the scope of the Act and diverted to animals intended for human consumption.
Section 3 provides for the enlargement of the Animal Remedies Consultative Committee which, under the 1956 Act, advised and assisted the Minister in the making of regulations under the Act. The Committee will have seven members. The extension of the size of the committee will ensure that all interests likely to be affected by regulations made under the Act will be adequately represented.
Section 4 deals with the information which must be conveyed on the container or outer wrapper in order to ensure safe and proper usage of the animal remedy. The same particulars must be stated on any advertisements for an animal remedy. The particulars required may be varied by regulation in appropriate circumstances.
The possession or control of an animal remedy in contravention of the provisions of the Bill or of regulations to be made thereunder, or of an animal or carcase, or animal produce knowing it to have been illegally treated, is an offence under section 6.
Section 7 inserts an implied condition in any contract of sale for an animal, or in the case of a carcase or any animal products, that the animal from which it was derived had not been illegally treated.
Section 8 empowers the Minister, following consultation with the Animal Remedies Consultative Committee, to make regulations — to control the availability, including manufacture and sale, advertising, possession and use of animal remedies; to prescribe maximum residues limits for animal remedies in foods of animal origin; for the control of animals to which animal remedies are administered and of food derived from such animals. The controls provided for include powers to restrict the sale, slaughter or movement to or from any place, and for the marking and detention of animals which are believed to have been treated with animal remedies. The disposal or destruction of illegally treated animals is also provided for. Section 8 also empowers the Minister to make regulations for the inspection and testing of substances, animals and food of animal origin and for the charging of fees in respect of such sampling and analysis.
This section also enables regulations to be made giving effect to Acts of the European Communities and validates regulations relating to animal remedies already made under the European Communities Act, 1972. This is a very important section as the regulations made under this section will regulate all day to day activities relating to animal remedies. When a new Bill is introduced there is always speculation about the type of regulations which will be made thereunder. In the case of this Bill the question is largely answered as the provisions relating to continuing in force of existing regulations will ensure a smooth transition in that the Bill once passed will be immediately operational.
The Minister shall, under section 9, prescribe approved methods of analysis for the determination of the composition of animal remedies or for the presence of residues in animal produce. The authorisation of the persons and bodies to carry out such analysis and for the admission of documents stating the results of such analysis as evidence in legal proceedings is also provided for under this section.
Section 11 confers extensive powers on authorised officers, officers of Customs and Excise and members of the Garda Síochána. I should mention that there is already very good co-operation between the different enforcement agencies in this area. These include, inter alia, powers to stop vehicles and enter any land or premises where there are reasonable grounds to believe that such vehicles, land or premises are used in connection with an animal remedy or an ingredient for an animal remedy, or are used in connection with the keeping or slaughter of animals, or where the offence under this Act has been, or is being, committed. Following entry, officers have extensive powers to search, examine, inspect, test or take samples and to seize and detain suspicious items as may be found thereon.
Persons connected with the afore-mentioned activities are required to produce relevant documentation or other items, including animals, and to give such information or assistance as may be requested by the officer or member concerned. This power is exercisable in respect of a dwelling only where there is reason to believe that relevant material would be destroyed before a search warrant could be obtained. The provisions here are in effect the same powers of enforcement as already applied under the regulations made under the European Communities Act.
Section 12 provides that a judge of the District Court may issue search warrants to an authorised officer, officer of Customs and Excise or member of the Garda Síochána to enter and search a dwelling house where there are reasonable grounds to suspect evidence of an offence is to be found therein. Members of the Garda Síochána and officers of Customs and Excise are empowered to search a suspect person under section 13. Section 14 empowers members of the Garda Síochána to arrest without warrant persons suspected of having committed an offence. Section 15 provides that nothing in the Bill shall curtail or prejudice other provisions of existing legislation in relation to powers to search or to seize or to detain property which may be exercised by members of the Garda Síochána or officers of Customs and Excise.
Section 17 provides that the Minister may issue composite identity cards to his officers in lieu of the separate warrants of authorisation prescribed by the various statutes in respect of which the officers are authorised. This provision is inserted because many officers are engaged in a wide range of duties and as a result are obliged to carry a large number of separate warrants. This provision will enable a single composite identity document to be issued to such officers.
Section 16 provides that any person who obstructs or impedes an authorised officer, an officer of Customs and Excise or member with the Garda Síochána in the enforcement of any of the provisions for by or under this Bill shall be guilty of an offence. Section 18 deems the impersonation of an authorised officer to be an offence. Section 19 provides that where it is not possible to prove the specific identity of an animal remedy in relation to which a contravention took place it will be sufficient to prove that contravention took place in relation to a particular class of animal remedy.
Section 20 makes it an offence to contravene by act or omission any provision of the Bill or regulations made or continued in force thereunder. It also provides that it shall be an offence to contravene a term or condition of any licence or authorisation given or granted under the Bill.
Section 21 relates to offences by bodies corporate and provides that where an offence is committed with the consent or connivance of any person who is a director, manager, secretary or other officer of the body corporate that person shall, in addition to the body corporate, be guilty of an offence and shall be liable to be proceeded against and punished as if guilty of the offence.
Section 22 empowers the Minister to prosecute summary offences and provides that summary proceedings may be instituted within two years of the date of the offence. This provision is considered necessary because the investigation of offences relating to animal remedies can at times be lengthy if all parties to the offence are to be identified and proceeded against. Under EC law we are obliged, in relation to certain offences, to trace breaches of the legislation back to the source of the illegal substance and to involve the authorities in other member states if necessary. Equally we could be asked by another member state to investigate a possible Irish link with a problem which came to light in their territory. In such circumstances it is important when the investigation is completed that we should not find the issue of proceedings statute barred. The provision gives an independent legal basis for prosecuting offences which is important in the context of the recent High Court decision on the European Communities Act, 1972, where regulations in this area were found invalid because they involved amending statute law by statutory instrument. This decision is under appeal to the Supreme Court.
Section 23 addresses the issue of penalties and offers a range of options appropriate for the offence involved so that the punishment shall match the crime. It is provided that maximum penalty on summary conviction shall be a fine of £1,000 or 12 months imprisonment. For conviction on indictment a maximum fine of £50,000 is provided, rising to £100,000 on second or subsequent offence, and ten years imprisonment or both. It is additionally provided in section 24 that on conviction on indictment for a second or subsequent offence a person may, in addition to the penalty imposed, be disqualified from keeping, dealing in or having control of any animal or class of animal or any animal remedy or be disqualified from working or participating in the food trade for such period, including the life of the person, as the courts thinks fit. This possibility should act as the ultimate deterrent and is important in that it enables the public to be protected from a person who operates with callous disregard for the health and welfare of innocent parties.
Section 25 empowers a court at its discretion to order the forfeiture of an animal, an animal remedy or other thing in relation to which an offence has been committed and section 26 deals with the manner in which items seized by authorised officers, members of the Garda Síochána, or officers of Customs and Excise will be disposed of. Section 27 enables the Minister to recover the cost of disposal of items seized or forfeited as a contract debt.
Section 28 to 31 deal with procedural matters such as the laying of orders and regulations before the Houses of the Oireachtas, the fixing and charging of variable fees and levies for different classes of licences and authorisations and the payment of expenses incurred by the Minister out of moneys provided by the Oireachtas.
Section 31 will continue in force all instruments, documents and authorisations issued under the Animal Remedies Act, 1956, which were in force immediately before the Act was repealed and ensure uninterrupted application of controls. Section 32 repeals the Animal Remedies Act, 1956, section 21 of the Diseases of Animals Act, 1966, and provides for the repeal of the Therapeutic Substances Act, 1932, by order of the Minister for Health following consultation with the Minister for Agriculture, Food and Forestry. These provisions arise because the subject matter of these instruments is now incorporated in this Bill.
These are the salient features of the Bill which I commend to the House and in so doing I would like to thank all the bodies who have contributed to its preparation.
I stated earlier that it is an appropriate time to introduce this legislation. The timing coincides with a major statement by the European Commission on the subject of the use of hormones and beta-agonists in livestock production. The general direction and thrust of the Commission's view is supported and the recognition of the need for a more direct and vigorous attack on the use of illegal substances is welcomed. Many of the Commission's recommendations are already in force in this country, and more are addressed in the Bill before us. I will also be asking the Commission to take account of the strong legislation in force in this country and to ensure that an equally vigorous approach is applied across the Community.
I look forward to an open and constructive discussion on the Commission's proposal at the Council of Ministers when the detailed proposals are presented. It is important that all aspects of the problem are considered. I am aware that there are wide ranging views as to how this problem should be addressed and that there are those who consider that the use of natural hormones should be relegalised by amending the Community law. However we have to recognise, first, that many of the substances being used illegally are far removed from and a good deal more potent than natural hormones, and, secondly, that the argument goes beyond the economics of production or the safety and efficacy of veterinary products.
We produce considerable amounts of food products for sale not just on our own domestic market but on a wide range of international markets. Therefore the requirements of the consumer are paramount. If consumers indicate that they do not want produce produced with the usage of these substances then that is the end of the argument.
This legislation has to be seen in a broader context of a comprehensive legislative approach designed to bring greater coherence and flexibility and to keep abreast of scientific and technological changes. This body of legislation is required regardless of whether natural hormones are legalised.
