In response to the query raised by Senator Norris, the explanatory memorandum was circulated and I am sure all Senators received it and have studied it in detail.
Perhaps, a Leas-Chathaoirligh, you would allow me to extend my personal good wishes to the Cathaorileach for a speedy recovery to health. I know this House has extended its collective good wishes to Senator Fallon and I would like to be associated with that.
The purpose of this Bill is to provide a single comprehensive basis for regulating the availability and use of animal remedies. The availability and use of animal remedies has consequences for the producer, the consumer and for the pharmaceutical industry. The relationship between animal health and successful livestock production is well recognised and apparent. In recent years the public health aspects of the safety of residues of animal remedies has come strongly into focus, and much research and analysis has been carried out into the safety of residues. Coupled with this awareness is the need to use animal remedies responsibly and carefully and to observe proper withdrawal periods. A no less important aspect, which may not be obvious to the casual observer, is the pharmaceutical industry which develops, manufactures and distributes the animal remedies and is a significnat investor and employer in the Irish economy. This is something which should not be overlooked.
When one looks at the broad range of activities which are influenced and affected by legislation relating to animal remedies, it is not surprising that the area is regulated by a variety of different instruments. At the present time the availability and use of animal remedies is regulated under four principal Acts: the Therapeutic Substances Act, 1932; the Animal Remedies Act, 1956; the Poisons Act, 1961 and the European Communities Act, 1972. The Misuse of Drugs Act, 1977, also applies to animal remedies with narcotic properties. In addition, the question of residues of animal remedies in food for human consumption is addressed under enactments such as the Agricultural Produce (Fresh Meat) Acts, 1930 to 1978; the Pigs and Bacon Acts, 1935 to 1978; the Milk and Dairies Acts 1935 to 1956; and the Abattoirs Act, 1988. This scattering of legislative controls does not facilitate equal and effective enforcement. Neither does it assist the law-abiding producer or consumer who wishes to understand more clearly what controls must be complied with. The greatest concern for enforcement authorities arises from the fear that loopholes may arise which enable the intended controls to be evaded. Therefore, this legislation is timely and necessary.
It is the intention of this Bill that animal remedies will be subject to a uniform set of controls from the point of manufacture to the sale for human consumption of food derived from treated animals. This is a vast area, as I have already mentioned, and the legitimate interests of a variety of different groups have to be appreciated and respected. I recognise that there are different interests and that the aspirations of each must be balanced to ensure that the wishes of any one interest group does not dominate to the detriment of any other party. I do not suggest, however, that there is any fundamental incompatibility between these parties. In fact, I would go further and say that their interests are interdependent and complementary. It is our function and duty as legislators to ensure that we create a legislative climate where all needs are addressed.
I do not consider this is an unrealistic aspiration. We are all consumers and have a mutual interest in ensuring that the food we consume is wholesome and is not contaminated by potentially detrimental substances. Additionally, we are anxious to be satisfied that our food is derived from healthy animals. Consumers are now very well informed regarding farming practices, in particular those relating to livestock production. They are rightly demanding assurances that any animal remedies administered to food-producing animals have been administered correctly, that proper withdrawal periods have been observed and that the substance used was authorised and is safe for use in food-producing animals.
Mechanisms are in place to ensure that these concerns are met. All animal remedies have to pass a vigorous evaluation before being placed on the market. Very stringent criteria of safety, quality and efficacy are applied to products before they receive a marketing authorisation. Particular attention is paid to the safety of residues and a great deal of work is underway at EC and other international organisation level to assess the safety of residues and to agree international standards.
In recent times it is regrettable that abuses of animal remedies have received so much attention. It has to conceded that it has, and does, happen and I will return to this point later. Apart from the public health concerns, which are well recognised, an equally serious outcome is that it has tarnished the reputation and image of the farming community. I must put on record that those who traffic in and use illegal substances are not representative of the rank-and-file genuine farmers. Clearly they are not friends of the consumer, neither are they friends of the farming community. Farmers and their families are also consumers and are just as concerned as the rest of the community about the quality of the food they produce and consume. Naturally, because their livelihood depends on it, they are anxious to ensure the health and welfare of their stock. Healthy stock are needed to produce quality food, to give a good product to the consumer and to give the producer a decent return for their investment and labour.
Farmers also recognise the reality of the market place and acknowledge that there is little point producing any commodity if there is no confidence and, consequently, no consumer demand for it. Farmers, therefore, depend on consumers for their livelihood and have to appreciate that their wishes must be respected and served if their custom is to be retained.
Of course, the consumer is not left entirely dependent on the goodwill of the producer. There are extensive official checks carried out on live animals, on farms and on carcases at slaughtering facilities and on milk at dairies and creameries to ensure that only authorised animal remedies are used, and are used correctly. These checks are carried out on a random basis and also on suspicion and are supplemented by regular checks on the distribution chain to ensure that only authorised products are put into circulation.
Moving back a stage from the farmer and animal owner who uses the animal remedy, we reach the pharmaceutical industry. I use this term generally to encompass the manufacturing and distribution activities. The pharmaceutical industry has come in for a share of criticism. People are very quick to condemn the industry for developing products which have come to be abused. However, we are quick to overlook the fact that most of these products were developed originally for bona fide purposes to treat clinical illness. We in Ireland enjoy an animal health status that is the envy of many of our trading competitors. We are all conscious of this health status and go to great lengths to protect it.
At a general level there has been dramatic improvement in animal health in recent years and many minor — in the sense that they are not exotic to this country — illnesses and diseases can be successfully prevented or treated by the judicious use of animal remedies. Many of these essential products are the result of many years of research and substantial investment by the pharmaceutical industry. The legitimate pharmaceutical industry in Ireland is making a substantial contribution to the improvement in animal husbandry.
The industry is not simply concerned with selling the solution to the various animal health problems which are encountered on a daily basis. Many firms are active through the promotion and sponsorship of educational and awareness schemes directed towards the farming community and the veterinary profession. The costs of developing new products are very high and after the development of the product, significant sums must be invested in carrying out the necessary studies to prove that the product meets the stringent standards of safety, quality and efficacy prescribed. If the industry is continue to invest in research and development of new, better and safer products they also must be protected against unscrupulous dealers in substandard, unauthorised and in some cases dangerous products. I repeat, there should be no conflict between the consumer, the producer and the pharmaceutical industry on this very important issue.
So far I have concentrated on the groups whose interests must be protected by the Bill we are considering. I will now turn to those against whom we all need protection, it is clear from the earlier proceedings in Dáil Éireann that I do not need to acquaint this House of the problem which exists in Europe in relation to the use of illegal substances for growth promotion purposes. We in Ireland, I regret to have to admit, have our share of this problem. Recent reports in the national and international media have not done anything to enhance the image of Ireland as a producer of quality, wholesome, natural food. This image has been the cornerstone of our marketing strategy and while good reputations are hard to earn they are even harder to re-establish.
Our live animal and meat exports are worth in the region of £1 billion annually. This sum is of immense significance to the economy as a whole but it is the life blood of the farming community. As I have already stated those who use these substances are unrepresentative and unscrupulous. They threaten the fundamental viability of our livestock and meat industry. Persons who supply or use these substances have been roundly condemned, and quite rightly so. The Members of Dáil Éireann have sent a loud and clear message that such actions will not be tolerated by the legislature and the magnitude of the permissible fines reflects that attitude. I assure this House that no effort will be spared to identify all involved in this activity and to bring them to justice.
Senators may be aware of the recent communication from the EC Commissioner for Agriculture, Rene Stecichen, who is reviewing the situation in the Community with a view to having more stringent and effective enforcement of the prohibition on the use of illegal substances. The general thrust of the Commissioner's view is supported and the recognition of a need for a well directed vigorous attack is to be greatly welcomed. Many of the measures being proposed are based on some of the controls already applied in Ireland. The passage of this Bill coincides with the renewed attention to this matter in the Community and will send a clear signal to our colleagues of our determination to put an end to this behaviour.
The use of growth promoters, whether legal or illegal, is a very short-sighted view of a means of ensuring farmers' prosperity. Consumers throughout the Community have, through the democratic process, indicated clearly that they do not wish to purchase or consume meat produced using any of these substances. The use of illegal substances has hardened consumer resistance to meat and meat products. This resistance needs to be overcome if the disturbing downward trend in meat consumption throughout the Community is to be reversed. Future prosperity for meat producers can only be assured by increasing the demand and the market for their produce. There are some commentators who suggest that the natural hormones should be legalised and this will prevent the abuse. This is erroneous thinking, however meritorious certain scientific arguments may be.
Before turning to the detailed provisions of the Bill I would like to draw special attention to one aspect. This is the fact that this Bill which we are considering provides for the transposition of future EC legislation dealing with any aspect of animal remedies into national law by means of regulations under this Bill. This will ensure a total consistency in the application of national and EC measures and will bring a greater coherence and flexibility to the law in this area. In view of the recent High Court judgment relating to the use of the European Communities Act for the purposes of implementing legislation, which is under appeal to the Supreme Court, it is appropriate that all our legislation should be based on a common denominator which enables conflict of laws to be readily resolved.
I will now preceed to outline the main provisions of the Bill.
Section 1 defines various terms and concepts for the purpose of the Bill. Many of the definitions employed are reenactments of the provisions of the 1956 Act. The only significant change is in the definition of an animal remedy which is revised to take account of Community law in this area 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. That committee had five members; it is proposed that the new committee will have nine members. The structure and appointment of the Committee was the subject of lengthy consideration by the Dáil and this section has been redrafted to reflect the views expressed in the Dáil. In proposing to extend the size of the committee I was mindful of the diverse interests materially affected by legislation relating to animal remedies. I was, therefore, most anxious to ensure that all interests likely to be affected by regulations made under the Act would be adequately represented. The section now provides for a Committee of nine persons of whom six will be appointed from nominees of groups such a veterinary surgeons, pharmacists, farmers, consumers, manufacturers and distributors of animal remedies and the food industry. I appreciate the interest shown by the Deputies on this matter and feel we now have a structure which will ensure transparency and confidence in the legislative process.
Section 4 deals with the labelling of animal remedies. The purpose of this section is to ensure that adequate information is conveyed on the container or outer wrapper of every animal remedy in order to ensure safe and proper usage of the animal remedy. The same particulars must be stated on any advertisement for an animal remedy. The particulars required may be varied by regulation in appropriate circumstances. It was pointed out during the Dáil debate that the indentification of bulk animal remedies was inadequately dealt with. I was happy to make an appropriate amendment to cover this aspect and I feel this issue is now comprehensively covered. Section 5 complements section 4 by prohibiting the publication of false or misleading particulars in relations to an animal remedy.
Section 6 addresses a number of issues arising out of possession of an animal remedy. The posession 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 prohibited under this section. Provision is also made to enable certain presumptions to be drawn from the possession of an animal or an animal remedy which will facilitate the enforcement of the provisions of this Bill.
Section 7 inserts an implied condition in any contract of sale that the animal or, in the case of a carcase or any animal product, the animal from which it was derived had not been illegally treated. This type of implied condition of sale is similar to the implied provisions of fitness of goods for the purpose for which they are intended which applies under the Sale of Goods and Supply of Services Act, 1980.
Section 8 empowers the Minister, following consultation with the Animal Remedies Consultative Committee, to make regulations relating to animal remedies. Arising out of the comprehensive nature of the Bill the regulation-making power covers an extensive area of application. Regulations made under this section may provide to control the manufacture, importation, distribution, sale, advertising, possession and use of animal remedies. Powers to prescribe maximun residue limits for animal remedies in foods of animal origin and for the control of animals to which animal remedies are administered are available under this section. The controls provided for include powers for marking, detaining or restricting the sale, slaughter or movement of animals which are believed to have been treated with animal remedies. Provision is made for the disposal or destruction of illegally treated animals. Regulations may also be made to deal with the inspection and testing of substances, animals and food of animal origin and for the charging of fees in respect of these activities.
In addition to the aforementioned matters which arise directly from this Bill this section 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 aspect in two respects. First, when a new Bill is introduced there is always speculation about the type of regulation which will be made thereunder. In the case of this Bill, the question is largely answered as the provisions relating to the continuation in force of existing regulations will ensure a smooth transition in that the Bill once passed will be immediately operational Secondly, it means that future EC directives in this area will be implemented and enforced as an integral part of our national law on the subject rather than being imposed as a series of independent measures.
Section 9 allows for the Minister to 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 addressed under this section. This section was subject to some technical amendment to clarify certain evidential matters during Dáil proceedings. The purpose and effect remain unchanged.
Section 10 provides for the authorisation of officers for the purpose of enforcing the provisions of the Bill.
Section 11 confers extensive powers on authorised officers, officers of Customs and Excise and members of the Garda Síochána. These include,inter alia, powers to stop vehicles and enter any land or premises where there are reasonable grounds to believe that they are used in connection with activities regulated by this Act or where an 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 which may be found thereon. Persons connected with the specified activities are required to produce relevant documents 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.
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 and 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, seize or detain property which may be exercised by members of the Garda Síochána or officers of Customs and Excise.
While the powers available under section 11 to 15 are very extensive, I would like to assure this House that the most severe aspects would only be employed in cases of suspected serious infringements. These provisions are based on the Misuse of Drugs Act, 1977, and are very similar to the powers of enforcement as already applied under the regulations made under the European Communities Act, 1972, I should mention that there is already good co-operation between the different enforcement agencies in this area and all the officers concerned deserve to be complimented on their efforts and success to date. Those going about their normal legitimate business need have no fear about these provisions.
Section 16 provides that any person who obstructs or impedes an authorised officer, officer of Customs and Excise or member of the Garda Síochána in the enforcement of any of the provisions provided for by or under this Bill shall be guilty of an offence.
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.
Many officers are simultaneously authorised to enforce the provisions of a multiplicity of Acts, for example, the Diseases of Animals Act, 1966, the Animal Remedies Act, 1956, the Pigs and Bacon Acts, 1935 to 1978, the Agricultural Produce (Fresh Meat) Acts, 1930 to 1978, the Abbatoirs Act, 1988, etc. This provision will enable a single composite identity document to be issued to such officers. To take account of the legitimate concerns, expressed in the Dáil, that officers seeking access to premises should be properly indentified, I have amended this section to provide for all composite cards to carry photograph of the bearer.
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 prescribes matters which constitute offences. Contraventions whether by act or ommission of any provision of the Bill, or regulations made or continued in force thereunder, or of a term or condition of any licence or authorisation given or granted under the Bill are deemed to be offences.
Section 21 relates to offences by bodies corporate. The purpose of this section is to prevent offenders evading personal responsibility for their actions by hiding behind a corporate veil. 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 offences.
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. Aside from obligations under EC law, it is essential if problems are to be tackled effectively that breaches of the legislation are traced back to the source of the illegal substance and that all parties involved are identified and dealt with. However, this comprehensive approach would be meaningless if we were to find that the institution of proceedings was statute barred on completion of the investigation.
Section 23 addresses the issue of penalties and offers a range of options appropriate to the offence involved so that, hopefully, the punishment shall match the crime. It is absolutely necessary that the penalites available must be sufficiently severe to act as a deterrent. My views on this matter were shared by many Deputies in the Dáil. It was their considered judgment that in the case of more serious offences, even more stringent penalties were called for because of the damage which could result from these activities. I was happy to defer to their views on this matter and the maximum penalties for the most serious categories of indictable offences have been substantially increased.
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 £100,000, rising to £250,000 on second or subsequent offence, and ten years imprisonment or both is provided. It is additionally provided in section 24 that on conviction on indictment, 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 court thinks fit. This is a very daunting prospect, but also a fitting one. Persons who behave with callous disregard for the health of innocent and trusting consumers cannot be allowed access to, and control of, products which will eventually end up in the food chain. Our food industry and the welfare of our consumers customers and farmers, at home and abroad, cannot be jeopardised and held to ransom by unscrupulous profiteers.
Section 25 enpowers 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.
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 standard 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 is repealed. The purpose of this section is to 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 Acts have been superseded by the provisions of this Bill.
These are the salient features of the Bill which I commend to the House, and in so doing would like to thank all the bodies who have contributed to its preparation. I think there is a broad consensus on what we are trying to achieve and I hope it will have the full support of this House.
In conclusion, I wish to acknowledge the commitment demonstrated by the Department of Agriculture officials in their work on the preparation of this Bill. I commend the Bill to the House