Thalathiah Saidin, Malaysia
1. Introduction
In Malaysia, veterinary drugs are used both in the aquaculture and livestock industry. The aquaculture sector is under the purview of the Department of Fisheries Malaysia, while livestock is under the purview of the Department of Veterinary Services. Both the agencies are responsible to regulate the food safety at source, that is at the farm level. Currently, there is no regulatory framework yet in place for the use of veterinary drugs in livestock and aquaculture sectors. However, there are codes of practices for good husbandry practices and good aquaculture practices. Although the codes are voluntary, but this administrative framework serves as a temporary measures while waiting for the regulations, which are at the final stage of being gazetted by the Minister of Agriculture and Agro-Based Industry Malaysia. For the livestock sector, it is regulated under the Animal Ordinance 1953, while the aquaculture sector is regulated under the Fisheries Act 1985.
The safety and wholesomeness of any food for the protection of the public from health hazard and fraud is governed under the Malaysian law by Ministry of Health Malaysia, under the Food Act 1983 and Food Regulations 1985. The safety of all foods including meat and meat products as well as fish and fish products are regulated by the Food Regulations 1985. Veterinary drugs residue comes under "Drug residue". This paper will deliberate regulatory framework governing the use of all drugs including veterinary drugs, and the drug residues as stipulated in the Food Regulations 1985, as well as highlighting the relevant section under the Animal Ordinance 1953 and the Fisheries Act 1985.
2. Legal Framework
Malaysia is taking every step to ensure that food from fish and seafood products as well as meat and meat products are safe and wholesome for human consumption based on legislations as follows:
i.) Food Act 1983 and Food Regulations 1985
With regards to the use of veterinary drugs and MRL of their residues in foods derived from fish and fishery products as well as meat and meat products, they are regulated under Regulations 37(1) and Regulations 40 of the Food Regulations 1985. Offences committed under these Regulations are spelt out in the Food Act 1983 under Section 13(A) and (B) enforced by Ministry of Health as the competent authority where food safety is concerned.
ii.) Fisheries Act 1985
Fisheries Act 1985 does not have provisions to control the veterinary drugs used in aquaculture. However, there is a provision under the Act, which empowers the Minister Agriculture to regulate aquaculture activities. Pursuant to this, a draft aquaculture regulation was prepared and awaiting approval by the Attorney's General Office. Under these regulations, the control of the use of veterinary drugs is incorporated, but the MRL of the residue is not being incorporated. The drug residue would be covered under Clause 61(ah) of the Fisheries Act which provides for the Minister of Agriculture to make regulations to prescribe standards for the quality control of fish or fish products and methods to effect such standards and control.
iii.) Animal Ordinance 1953
Under this Ordinance, no provision to control or regulate the use of veterinary drugs and their residues in the livestock industry are incorporated. Veterinary drugs used in the livestock industry and their MRL are as stipulated in the Food Act 1983 and Food Regulations 1985. The Ordinance is under review and also a new Act on animal feed, including aquaculture feed is now being scrutinized by the Attorney General's Chamber.
3. Food Act 1983 (Act 281)
This is the mother act promulgated to protect the public against health hazards and fraud in the preparation, sale and use of food, and for matters incidental thereto or connected therewith. Under Part 1 Preliminary, interpretation of certain relevant and important terms are described as follows:
"Food" is interpreted as "includes every article manufactured, sold or represented for use as food or drink for human consumption or which enters into or is used in the composition, preparation, preservation, of any food or drink and includes confectionery, chewing substances and any ingredient of such food, drink, confectionery or chewing substances". Consequently, fish and meat products fall under "animal" includes any quadruped or bird either domesticated or otherwise, fish, reptile or insect; whole or part of which are used for human consumption.
Food regulated under this Act comes into force at the point of sale. The "sell or sale" refers only to sale for human consumption or use and includes barter and exchange, offering or attempting to sell, causing or allowing to be sold, exposing for sale, receiving, sending, conveying or delivering for sale or exchange or in pursuance of such sale or exchange, supplying any food where consideration is to be received by the supplier for such supply either specifically or as part of a service contacted for sale or exchange, or having in possession any food or appliance knowing that the food or appliance is likely to be sold or offered or displayed or exposed for sale or disposed of for any consideration, and includes electronic sale".
4. Offences Committed Under The Food Act 1983 and Food Regulations 1985
Offences under the Act is described in Part III under "Offences and Evidence" that are relevant to the offences committed pertaining to the drug and drug residue in food.
Under Section 13: Food containing substances injurious to health states that;
(1) Any person who prepares or sells any food that has in or upon it any substance, which is poisonous, harmful or otherwise injurious to health commits an offence and shall be liable, on conviction, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding ten years of to both.
(2) In determining whether any food is injurious to health for the purpose of subsection (1), regard shall be had not only to the probable effect of that food on health of a person consuming it but also to the probable cumulative effect of the food of substantially the same composition on the health of a person consuming the food in ordinary quantities. This is further re-enforced under Section 13A(2) under "Food unfit for human consumption", which states that:
"Any person who prepares or sells any food that contains or upon which there is any matter foreign to the nature of such food, or is otherwise unfit for human consumption, whether manufactured or not, commits an offence and shall be liable, on conviction, to a fine not exceeding thirty thousand ringgit or to an imprisonment for a term not exceeding five years or to both.
In addition, Section 13B (2) which is applicable to the contamination with prohibited veterinary drugs states that food is adulterated if it contains any substance the addition of which is not permitted by the Act or any regulations made under this Act, or it does not comply with the standard or specification prescribed by any regulations made under the Act, or if it contains a greater proportion of any substance than is permitted by this Act or any regulations made under the Act. The addition of any substance to the food shall be deemed to be not permitted or shall be deemed to be prohibited by or under this Act if the standards or specifications prescribed for the food by regulations made under this Act do not expressly provide for the addition of such substance. A person who contravenes any of the provisions of this section commits an offence and shall be liable, on conviction, to a fine not exceeding twenty thousand ringgit or to imprisonment for a term not exceeding five years or to both.
5. Food Regulations 1985
Under Section 34 of the Food Act 1983, The Food Regulations 1985 was enacted by the Minister of Public Health. These Regulations regulate the food imported into the country and food produced by local manufacturers, processors and packers, as well as conditions for placing the food in the market for public consumption. The Regulations comprised of ten Parts, where Drug Residue falls under Part VII: Incidental Constituent. The drugs here refers to all kinds of drugs including veterinary drugs.
Regulation 37 (1) stipulates that "incidental constituent" means any foreign, extraneous, toxic, noxious or harmful substances that is contained or present in or on any food and includes metal contaminant, microorganisms and their toxins, drug residue and pesticide residue but does not include preservative, colouring substance, flavouring substance, flavour enhancer, antioxidant, food conditioner, non-nutritive sweetening substance or nutrient supplement or any other substance permitted to be added to food by these Regulations.
6. Drug Residue and MRL
Regulation 40 of the Food regulations 1985 deliberates on the usage of various types of veterinary drugs in animals and the MRL allowed, as well as the drugs which are prohibited in food intended for human consumption. The excerpts of the Regulations are as follows:
Regulation 40:
(1) In these Regulations, "drug" means any substance or mixtures used internally or externally for therapeutic, prophylactic or growth promotion purposes or for modification of physiological function or behaviour in mammals.
(2) "Drug residue" means the parent compounds of the drug and/or their metabolites in any edible portion of the animal product, and includes residues of associated impurities of the drug concerned.
(3) No person shall import, sell, expose or offer for sale or delivery, any food intended for human consumption which contains drug residues greater than the amount as set out in Table 1, to the Fifteenth A Schedule.
(4) Notwithstanding subregulation (3), either chlortetracycline or oxytetracycline may be incorporated in ice used for preserving fresh fish, and unpeeled shrimps, provided that the concentration of one of these drug shall not exceed 5 parts per million in the product.
(5) Notwithstanding subregulation (3) and (4), no person shall import, sell, expose or offer for sale or delivery, any food intended for human consumption which contains the drugs as set out in Table II to the Fifteenth A Schedule.
Fish, under these Regulations includes any marine, brackish water or fresh water fish, crustacean, mollusc and other aquatic life that is edible by human being. This would cover also for all fish and fish products for human consumption. Whereas meat or fresh meat, shall be the edible part of the skeletal muscle of an animal, other than fish, that is normally used for human consumption and that was healthy at the time of slaughter. It may contain accompanying and overlying fat together with portions of the bone, skin, sinew, nerve and blood vessels that normally accompany the muscle tissue and are not separated from it in the process of drying. It may be accompanied by edible organs. Both fish and meat come under the definition of food as stipulated under the Food Act.
The maximum permitted proportion of the drug residues in Table 1 of the Fifteenth A Schedule for Drug Residue, the MRLs set are for meat and meat products only. No MRLs are set for any fish and fish products. The unit of MRL is microgram per kilogram or parts per billion (ppb). The prohibited drugs in food are Beta agonists, Nitrofurans and Chloramphenicol as listed in Table II to the Fifteenth A Schedule.
The issue of veterinary drug residue and MRL is not being given much attention in the past. However, since this issue has been debated in international seminars and conferences, as well as trade matters related to SPS and TBT Agreements, this subject of MRL is now being deliberated in Malaysia. The constraints faced by most of the relevant agencies, particularly the Department of Fisheries Malaysia, is the lack of capacity in MRL development for aquaculture products. Hence, effort is now underway to build capacity in MRL for alternative permitted veterinary drugs in shrimp aquaculture under the Trilateral Partnership between Malaysia, Indonesia and The Netherlands. Another constraint is the inability to analyze the residue at very low level of detection down to parts per billion or ppb and also the absence of technically suitable laboratory equipment to analyze very low level of detection. Besides organizing hands on training on for the relevant staffs, procurement of suitable equipment is in progress. Currently, while waiting for the equipment to be purchased, collaboration and assistance form other laboratories in the country that have the equipment and the expertise have been started for two years now. In addition, precautionary measures and awareness programmes are being undertaken at the production level to educate farmers on Good Aquaculture Practices and Good Husbandry Practices, where the use of prohibited substances is being given high attention. This is an interim measure while waiting for the aquaculture regulations to be gazetted under the Fisheries Act 1985 by the Minister of Agriculture and Agro-Based Industry.
7. Conclusions and Recommendations
Although there is regulatory framework for the control of the use of veterinary drugs in Malaysia, its enforcement is still not satisfactory as the law governed and regulated by Ministry of Health is for food at the point of sales. Since the usage of the veterinary drugs is at the production or farm level, more awareness and education programmes at the farm level will be intensified. Since the current legislation is inadequate to control its usage effectively, the review of these legislations is pertinent as well as enacting new regulations on MRL and veterinary drug residue to ensure that practices at the farm level complies with the food safety standards.
8. References
The Malaysian Food Act 1983 and Food Regulation 1985. Ministry of Health Malaysia.
Annual Fisheries Statistics 2002 Vol.1. Department of Fisheries Malaysia. ISSN 0126-8856.
