Botswana- Statutory law - Animal production
Animal Production
Botswana
SUMMARY
Animal identification and traceability are regulated by the Branding of Cattle Act and the Diseases of Animals (Animal Information and Traceability System) Regulations, 2018. All cattle must be identified by use of bolus, and digital or analogue ear tags and branded with the appropriate zonal brands within three months of birth or within 72 hours after purchasing or otherwise acquiring any livestock and before removal of such livestock from the place of purchase or acquisition. The government establishes and maintains a computerised database for traceability purposes. The law requires all animal holdings to be registered. Establishments crucial to livestock development such as animal care centres; semen collectors; embryo transferors; inovulators; and livestock breeders’ societies must be approved by the Registrar in the Department of Animal Production.
All stock movements require a stock movement permit issued by the Director of Veterinary Services. The law appoints stock traceability managers and assistants to implement the stock traceability system.
Feed safety and quality is regulated by Botswana Medicines Regulatory Authority (BOMRA) which is responsible for implementing and managing the requirements pertaining to production, distribution, import and export of animal feeds. It has to ensure that all medicines and related substances manufactured in, imported into, or exported from, Botswana are registered and conforms to established criteria of quality, safety and efficacy. BOMRA inspects premises where medicated feeds are used, handled or stored.
All feed business operators, including those dispensing and manufacturing premix feeds must be licensed. The Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 - Document No: BOMRA/IL/IL/P03/G01 requires operators of VMPs to implement self-control systems in the sale or distribution of veterinary medicinal products.The law prohibits the manufacturing of feeding stock which contains poultry excreta; meat and bonemeal or any other protein of ruminant origin; or waste which contains any animal derived protein. All feeding stock, which are intended for retailing must be conspicuously marked- "This product does not contain any poultry excreta, meat and bonemeal, or any other protein of animal origin".
Generally, the usage, handling, storage, transportation, distribution and sale of anabolic hormones and thyrostatic substances for use in animals is prohibited. However, the veterinary surgeons may be authorised to acquire and use the prohibited substances for therapeutic treatment only.
The law obliges the holder of market authorisation to recall medicines upon being aware that of a safety, efficacy or quality problem which could have detrimental effects on public health. Guidelines on Product Recall and Withdrawal, 2020 - Document No: BOMRA/PCT/PMS/P01/G01 provides guidelines on recalling medicines and related substances.
All importations and exportations of VMPs are upon being granted a permit. Guidelines for Import/Export of Medicines BOMRA/IL/IE/P02/G01 provides guidance on importation and exportation of VMPs. An application for an import permit has to be accompanied by an authorisation from a market authorisation holder to import medicines to Botswana in line with the guidelines. Consignments of medicines must be imported through designated ports of entry and inspected by BOMRA inspectors, Customs or Port Health inspectors to ensure that they comply with the approved specifications and regulations before they are released.
Cruel treatment of domestic and wild animals is prohibited. When importing, exporting or transporting live animals, necessary steps must be taken to minimise the risk of injury, cruelty or damage to its health during transport or transhipment of the animal to its destination. Activities such as cruelly beating, kicking, ill-treating, over-driving, over-riding, over-loading, or torturing any animal are prohibited. Council Bye-Laws require that animals be kept in stables that are conducive to their health otherwise they can be destructed. When slaughtering animals, Council Bye-Laws such as those for Gaborone require that animals must not be slaughtered in such manner that cause undue suffering, pain and distress, and as such the preferred method of slaughtering in Gaborone is shooting.
Aquaculture is a developing sector in Botswana. A permit from the Director of Wildlife and National Parks permit is required to capture fish for breeding or farming purposes, while a separate permit from the Department of Aquaculture and Apiculture is needed to engage in aquaculture activities. An Environmental Impact Assessment (EIA) is required in the following instances: construction of fish-farming production systems with a capacity of 4000 m3 or more; where there is any direct discharge from the production system to a receiving water body; commercial fish farming venture with an annual production of 20 tonnes or more; and fish farming production systems where exotic species will be used. The restrictions upon the use of certain chemicals in aquaculture activities is overseen by the Conservation Committee established in terms of the Agricultural Resources Conservation Act.
The key institutions in animal production are: - Department of Animal Production, Department of Aquaculture and Apiculture (DAA), Department of Wildlife and National Parks, Department of Veterinary Services, and Botswana Medicines Regulatory Authority (BOMRA). Currently, the Department of Veterinary Services (DVS) is the controlling authority for the purposes of animal production purposes. It has licensing and inspectorate/supervisory powers. The Director of DVS is responsible for licensing various premises like abattoirs, cutting premises, cold stores, farmed game handling facilities, and farmed game meat plans.
The Livestock Improvement Act creates the Animal Production Advisory Board whose functions includes advising the Minister on matters concerning the development and improvement of the livestock industry and the development of farmed game. Also, the Act empowers the Minister to appoint an animal scientist from the Department of Animal Production as Registrar. The Registrar serves as Secretary to the Animal Production Advisory Board and is responsible for maintaining a record of the Board’s discussions and decisions, and the day-to-day administration of the Board.
The Agricultural Resources Conservation Act establishes the Agricultural Resources Board. The Board exercises supervision over the agricultural resources of Botswana and advises the Minister regarding, amongst other things, the nature of legislation necessary to secure or promote the proper conservation, use and improvement of agricultural resources. It may also issue conservation orders and stock control orders.
The Department of Veterinary Services plays an important role in stock identification movement of animals, and animal welfare matters. DAA focuses on aquaculture, and DWNP deals with wildlife issues. BOMRA is also essential institution in the regulation of VMPs. It licenses operating businesses in the import, export, sale and distribution of VMPs. The DAP and DVS collaborations on the provision and operation of wildlife quarantine facilities, including the provision of veterinary services. Similar cooperations are witnessed between BOMRA and BURS in the importation and exportation of medicines and related substances.
ANIMAL IDENTIFICATION AND TRACEABILITY
GENERAL REQUIREMENTS
Animal identification and traceability is regulated by the Branding of Cattle Act, 1961 and the Diseases of Animals (Animal Information and Traceability System) Regulations, 2018. The Branding of Cattle Act provides for zonal branding areas as per the President's order, whereas the Diseases of Animals (Animal Information and Traceability System) Regulations, 2018 provides for establishment and maintenance of a computerised database for registration of all cattle. Information to be recorded include the particulars of the animal; registration details of the owner; the holding where animal is being kept; and the animal identification device to be used. In addition to the computerised database, the Director of Veterinary Services must maintain a register which include information such as the number of the stock movement permits issued in terms of the Regulations; the vaccination and other medical treatment of an animal; the animal mortality; the movement of an animal from one place to another and the slaughter record of an animal. The law guarantees confidentiality of information submitted in accordance with the animal identification and traceability system. However, such information may be disclosed in the interest of public health and safety, national security, planning, public welfare, and diseases or pest control, and upon request by law enforcement officers.
Currently, the Control of Livestock Industry Act plays an important role in animal production. This Act regulates the purchase of livestock and livestock produce, the export of livestock and livestock produce, the licensing of export slaughterhouses and the supply of livestock to an export slaughterhouse and introduces a levy on cattle exported. It establishes a system of permits for each tribal area for the sale or disposal of livestock by persons subject to any Botswana customary law. The purchase or acquisition of livestock in general requires a livestock buyer's licence or a livestock buyer's agent's licence. Licences may be granted free of charge to a specified category of persons involved in the livestock industry. Every holder of a licence shall regularly render to the Director of Veterinary Services a return of livestock transactions. All livestock shall be branded after purchase or acquisition. Further restrictions are places on the purchase, sale and disposal of livestock. No person shall export any livestock unless he or she is the holder of a certificate of registered exporter or a registered producer and is in possession of an export permit issued by the Director of Veterinary Services. Purchase or acquisition of livestock produce (including poultry and poultry products) for the purpose of trade requires a licence issued by the District Commissioner.
The Livestock Sales (Permits) Regulations, 1973 regulates the issuing of permits. It requires the licenced livestock buyers to record all purchases, acquisitions, sales, exchange or other disposals of livestock.
Various laws define the term "animal”, and the widest definition is found in the Cruelty to Animals Act. It defines animals as "any horse, mare, gelding, bull, cow, ox, heifer, steer, calf, mule, ass, sheep, lamb, hog, pig, sow, goat, ostrich, dog, cat, or any other domestic animal, fowl or bird and includes any wild animal in a state of captivity". For conservation purposes, the Wildlife Conservation and National Parks Act state that "animal" means and includes any vertebrate or invertebrate animal or fish, bird and the eggs and young thereof, but does not include a domestic animal or bird, or the eggs and the young thereof."
In terms of the Cruelty to Animals Act, 1936, an "owner" is " in addition to its ordinary meaning, includes any person having the charge, custody or control of any animal." The Control of Livestock Bye-Laws passed in different districts provides a broader definition: "owner" means, in relation to any animal, in addition to its ordinary meaning, any person having the charge, custody or control of any animal and the occupier of any premises where any animal is kept or permitted to remain". The Diseases of Animals (Animal Information and Traceability System) Regulations, 2018 defines terms such as "custodians"; "business operators" and "movement of an animal". A "business operator" means a person who operates an animal production or animal product processing facility", while "custodian" means a person who is acting with the authority of the owner of an animal, or who is in charge of the day-to-day farm management decisions with respect to an animal." "Movement of an animal" or "stock movement" means when an animal is introduced into or leaves an area or holding."
REGISTRATION OF ESTABLISHMENTS
The Livestock Improvement Act, 2009 and its 2021 Regulations seeks to improve the livestock industry in Botswana. This Act require all animals to be used for the collection of semen, ova or embryo to be approved by the Registrar. An animal is approved if the Stud Book Association on the recommendation of the livestock breeders’ society concerned has certified that the pedigree and prescribed performance records of such animal are of such a nature that the use of the semen of that animal for the purpose of the artificial insemination of animals would, in his or her opinion, be in the interests of the livestock industry. Also, the veterinary surgeon must certify that such animal is acceptable in respect of its general state of health; there is absence of disease and /or prescribed hereditary defects; and further certify the quality of its semen and any such other attributes as may be prescribed. Further this Act require centres responsible for semen, ova or embryo collection and artificial insemination to be registered. The Registrar must establish and maintain a register of the following: semen collectors; embryo transferors; inovulators; centres; animals registered or approved for the collection of semen, ova or embryo; and livestock breeders’ societies. Further, the Act provides for the registration of livestock breeders societies, which a group of persons promoting the breeding, improvement and use of animals.
The Diseases of Animals (Animal Information and Traceability System) Regulations, 2018, requires the registration of holdings. Holdings are farms or other agricultural undertaking belonging to different keepers within a communal area, such as a kraal, ranch or feedlot where animals are regularly kept or bred, and the boundaries of which are defined by a physical or virtual fence.
ANIMAL IDENTIFICATION AND REGISTRATION
The Diseases of Animals (Animal Information and Traceability System) Regulations, 2018, identifies cattle and ostrich as the species that are subject to identification requirements. Small stock, such as goats have also been included. The Director may develop an animal identification system for any other stock as and when it is required. The law prescribes the methods of identification. Cattle are identified by use of branding in accordance with the Branding of Cattle Act, 1961 and use of animal identification device such as bolus, and digital or analogue ear tag. The cattle must be identified within six months from birth, and an owner or custodian shall not move an animal from one holding to another without having tagged such animal. In relation to an ostrich, identification is by the use of a registered holding of origin and an approved individual animal identification.
The Diseases of Animals (Animal Information and Traceability System) Regulations, 2018 provides for establishment and maintenance of a computerised database for registration of all cattle. The database has to record the following information-
The Diseases of Animals (Animal Information and Traceability System) Regulations, 2018 provides for establishment and maintenance of a computerised database for registration of all cattle. The database has to record the following information- (a) the colour of the animal, which shall be written in Setswana. (b) the age of the animal. (c) the gender of the animal. (d) an owner identification number. (e) the animal identification device and analogue tag number of the animal. (f) the brand of the animal, and the position of the brand. (g) the animal holding. (h) the OIE disease status of the animal. (I) the zone where the animal is kept; and (j) the date of registration or tagging of the animal.
RECORD OF ANIMAL MOVEMENTS
The Director of Veterinary Services is mandated by the Diseases of Animals (Animal Information and Traceability System) Regulations, 2018, to maintain records of stock movement permits. The information to be recorded in relation to stock movement permit include the name, address, national identity card number and owner registration number of the owner; the origin holding and destination holding and the territory, disease control zone, district, extension area, crush and holding. The law requires the owners or custodians of animals to notify the Director of any movement of animals from one zone or holding to another. In any event, to move the animals require a stock movement permit or cattle removal permit in the case of animal moving to an export slaughterhouse or abattoir for slaughter. It is mandatory to keep records of all animal movements, including transfers between different holdings.
In addition to the computerised database, the Director of Veterinary Services has to maintain a register which include information such as the number of the stock movement permits issued in terms of the Regulations; the vaccination and other medical treatment of an animal; the animal mortality; the movement of an animal from one place to another and the slaughter record of an animal.
The Disease of Stock Regulations also regulates movement of animals. It specifically requires all animal movements to be granted a permit. The permit must indicate the number and class of stock to be moved and the route to be followed. The person in whose name the permit is made out is entirely responsible for all the conditions and restrictions of such permit being carried out. The animal movement permit may be withdrawn at any time.
ANIMAL INSPECTION
The Diseases of Animals Act and the Diseases of Animals (Animal Information and Traceability System) Regulations, 2018, empowers the competent authority to appoint inspectors to support enforcement of animal identification and traceability requirements. The appointed personnels are the Director of Veterinary Services, including the Deputy Director of Veterinary Services and any officer authorized by the Director. The Diseases of Animals (Animal Information and Traceability System) Regulations, 2018, empowers the Director to appoint stock traceability manager and assistant stock traceability managers. A stock traceability manager is responsible for implementing a stock traceability system which is used to trace all stock and keeping and maintaining an updated centralised stock information technology data management system. The stock traceability manager, known as the BAITS Coordinator, is the first point of call on any issue regarding traceability of stock.
The Branding of Cattle Act outlines the requirement for the appointment of a Registrar and Assistant Registrar of Brands responsible for maintaining the register of brands. Assistant Registrar of Brands operates at the District level and are assigned with the responsibility of maintaining the register of brands. The Diseases of Animals Act grants departmental officers powers to enter on any land, building, shed, place, carriage, van, truck, vessel or aircraft containing or conveying or used for conveying animals for the purpose of inspecting or examining any stock, carcass, article or vehicle to ascertain whether or not the provisions of this Act are being properly carried out. Departmental officers are defined to include stock inspectors.
Further, the Diseases of Animals (Animal Information and Traceability System) Regulations, 2018, grants the Director powers to visit and inspect any holdings, slaughterhouse or abattoir to ensure compliance with laws. During the inspection in holdings, the Director has to verify notifications of events such as tagging, treatments, movements, ownership or transfer of animals; that there is correct application of ear tags, and that there is no tampering with ear tags. At slaughterhouses or abattoirs, the Director may request to be furnished with copies of the animal identification and trace-back records, within such time as he may specify.
Criminal sanctions are imposed for offences related to animal identification and traceability. Any person who contravenes any provision of the Diseases of Animals (Animal Information and Traceability System) Regulations may face a fine of up to P5000, imprisonment for a term not exceeding five years, or both. Similarly, under the Branding of the Cattle Act, it is considered an offence to fail to brand animals with the required zonal brands, alter or deface a zonal brand, or use unregistered brands. The penalty for failing to brand animals or using unregistered brands is a fine not exceeding P200, imprisonment for a term not exceeding six months, or both. Defacing or altering a brand carries a penalty of a fine not exceeding P1200, imprisonment for a term not exceeding four years, or both.
FEED SAFETY AND QUALITY
GENERAL REQUIREMENTS
The general requirements on feed safety and quality are provided in the Medicines and Related Substances Act (MRSA) as read with Diseases of Animals (Stock Feed) Regulations, 2004; Medicines and Related Substances Regulations, 2019; and the Diseases of Animals (Prohibition of use of Anabolic Hormones and Thyrostatic Substances) Regulations, 1987. The MRSA establishes the Botswana Medicines Regulatory Authority (BOMRA), which is responsible for implementing and managing the requirements pertaining to production, distribution, import and export of animal feeds. Specifically, BOMRA has to ensure that all medicines and related substances manufactured in, imported into, or exported from, Botswana are registered and conforms to established criteria of quality, safety and efficacy. Also, it has to inspect or cause to be inspected, premises where medicated feeds are used, handled or stored. The Act require the preparation of premix to be only done at a feed mill authorised to manufacture medicated feed by BOMRA acting in consultation with the Department of Veterinary Services. Preparing premix without authorisation is an offence which attracts a fine not exceeding P500 000 or to imprisonment for a term not exceeding three years, or to both. Also, the Act prohibits the operation of a feed mill exception under a license from the Department of Veterinary Services.
In terms of the MRSA and its Regulations any medicine, including medicated feeds, imported, manufactured or dispensed within Botswana must be labelled and include any warnings or precautions that may be necessary or desirable. The Diseases of Animals (Stock Feed) Regulations, 2004 prohibits the manufacturing of feeding stock which contains – (a) poultry excreta. (b) meat and bonemeal or any other protein of ruminant origin; or (c) waste which contains any animal derived protein. This law therefore requires all feeding stock, which are intended for retailing must be conspicuously marked)- "This product does not contain any poultry excreta, meat and bonemeal, or any other protein of animal origin".
Also, the Diseases of Animals (Prohibition of use of Anabolic Hormones and Thyrostatic Substances) Regulations, 1987 mandates the Director of Veterinary Services to list anabolic hormones and thyrostatic substances that are prohibited for use in animal feed. Generally, the usage, handling, storage, transportation, distribution and sale of anabolic hormones and thyrostatic substances for use in animals is prohibited. However, the veterinary surgeons may be authorised to acquire and use the prohibited substances for therapeutic treatment only. The law further authorises the Director of Veterinary Services to prescribe prohibited substances for use in animals.
OPERATOR'S REGISTRATION AND LICENSING
The legal framework governing registration and licensing of feed business operators is laid down in the Medicines and Related Substances Act (MRSA). This law requires that any person who intends to produce feed, including mixing and reformulating of feed for commercial purposes to be licensed. Also, the dispensing and manufacturing of medicine, including premix feeds must only be undertaken in an establishment licensed by the Authority. The costs and procedures of licensing the operators and their establishments are prescribed for in the Medicines and Related Substances Regulations, 2019 as read with the Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 - Document No: BOMRA/IL/IL/P03/G01. These Guidelines requires the operators to implement self-control systems in the sale or distribution of veterinary medicinal products. A written prescription is needed to dispense medicated feeds. The law requires all medicated feed to be produced from medicines that are registered by the Authority. Unwanted medicated feeds must be properly disposed in line with the guidelines issued by the Authority.
BOMRA is authorised to withdraw licenses if the holder breaches any conditions of the license, and does not meet standards and guidelines, in particular the Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 -Document No: BOMRA/IL/IL/P03/G01. Where the licence holder has failed to comply with the license's conditions, BOMRA will notify the license holder, may indicate the actions to be taken by the license holder and give the license holder seven days to respond. The facility must remain closed for the suspension duration of 30 days while action is being taken to address non-conformances. Where a license is withdrawn, the facility shall cease to operate.
TRACEABILITY, WITHDRAWAL AND RECALL
To facilitate traceability, the Medicines and Related Substances Act (MRSA) requires importers, exporters, manufacturers, distributers, dispensers, or users of veterinary medicinal products to keep records of all transactions or activities relating to the medicines they import, export, manufacture, distribute, dispense, or uses. Further, the law obliges the holder of market authorisation to recall medicated feeds upon being aware that of a safety, efficacy or quality problem which could have detrimental effects on public health. Furthermore, individuals are obligated by law to notify BOMRA of any negative responses experienced by a human after consuming an animal that was fed medicated feed or premix, provided the medication has been registered. Additionally, any adverse reactions in a person due to handling medicated feeds or any adverse reactions observed in an animal following the administration of registered medicated feed or premix must be reported to BOMRA.
The Guidelines on Product Recall and Withdrawal, 2020 - Document No: BOMRA/PCT/PMS/P01/G01 provides guidelines on recalling medicines and related substances. It indicates that before or upon initiating a recall, the company immediately on becoming aware of the problem, must notify the Authority and other stakeholders. The notification must include: a) The reason for initiating the recall - nature of defect/problem. b) Name, strength, pack size, batch/lot number and any means of identification of the recalled product. c) Total quantity of the product being recalled originally in possession of the company. d) The date distribution of the product began. e) The total quantity of the product being recalled that had been distributed up to the time of the recall should be indicated. f) Area of distribution of the product and, if exported, the country to where it was exported. g) List of customers to whom product was issued. h) The quantity of the recalled product still in the possession of Marketing Authorization Holder. i) Suggested action to be taken and its urgency. j) Indication of the health risk together with reasons. k) Any adverse events observed/reported for the product being recalled. The costs of withdrawals and recalls of compromised medicines and related substances is borne by the marketing authorisation holder.
STORAGE AND DISTRIBUTION
Storage and distribution of VMPs including medicated feeds is regulated by the Medicines and Related Substances Act (MRSA)and accompanying Regulations. The Act requires that medicated feeds be kept in storage, distributed and sold in accordance with such conditions as may be prescribed. Also, that all feeds must be stored in secure, well-ventilated rooms, with adequate lighting and controlled temperatures. Storage facilities must be protected from pests, harsh weather and meet building codes. Feeds meant for ruminant animals must be clearly separated from those meant to non-ruminant animals. Storing, distributing and selling medicines contrary to the prescribed conditions is an offence that attracts a fine not exceeding P100 000, or to imprisonment for term not exceeding 10 years, or to both.
The Diseases of Animals (Stock Feed) Regulations, 2004 provides for the labelling of stock feeds. All products manufactured or constituted for the purpose of feeding stock, which are intended for retailing shall, be conspicuously marked)- “This product does not contain any poultry excreta, meat and bonemeal, or any other protein of animal origin”. While the law does not per se prescribes packaging requirements, if one intends to change the packaging prior authorisation is needed.
The Guidelines for Operating a Veterinary Medicinal Products Retailer, 2022 -Document No: BOMRA/IL/IL/P03/G01 require that all medicated feeds be stored in accordance with the manufacture’s recommendations. Also medicated feeds must be stored separately from non-medicated feeds to prevent cross-contamination. In terms of the MRSA storing, distributing and selling medicines contrary to the prescribed conditions is an offence that attracts a fine not exceeding P100 000, or to imprisonment for term not exceeding 10 years, or to both.
To facilitate traceability, the Medicines and Related Substances Act obliges an importer, exporter, manufacturer, distributer, dispenser, or user of veterinary medicinal products to keep, in the prescribed form, records of all transactions or activities relating to the medicines they import, export, manufacture, distribute, dispense, or use. Failure to keep records is an offence which attracts a fine not exceeding P100 000, or to imprisonment for a term not exceeding two years, or to both.
FEED IMPORT
Importation of premix is regulated by the Medicines and Related Substances Act. In terms of the Act “premix” is a mixture of one or more active pharmaceutical substances, solely intended for mixing into animal feed for production animals and is regarded as medicine. Importation of all premixes requires a permit, currently being issued by the Department of Veterinary Services. The Medicines and Related Substances Regulations provide the procedure for applying for an import permit. The Regulations are complemented by the Guidelines for Import/Export of Medicines BOMRA/IL/IE/P02/G01. An application for an import permit has to be accompanied by an authorisation from a market authorisation holder to import medicines to Botswana in line with the guidelines. Import permits may be granted to licensed wholesalers and import permits to unlicensed wholesalers is upon assessment by BOMRA. All purchasing orders are to be vetted and authorised by the Authority. A person authorised to import medicine must pay an importation fee for each consignment which is 0,15% of the value of the consignment. Upon receipt of medicines, a wholesaler must notify the Authority and submit an acknowledgement.
The importation of all consignments of premixes is through the designated ports of entry provided in the guidelines. On arrival at the ports of entry, medicines are inspected by BOMRA inspectors, a Customs or Port Health Officer to ensure that they comply with the approved specifications and regulations before they are released. Other government agencies such as Botswana Police may also conduct inspection activities to ensure compliance with the law.
Port Health Officers, who are authorized by the Public Health Act, are responsible for conducting inspections of products to ensure they meet health standards. The Excise Duty Act permits the Commissioner General of BURS to cause destruction of goods or delay release of goods on the grounds of protecting public health. Similarly, sections 35 and 271 of the Customs Act empowers the inspector to refuse importation and dispose the products. Grounds of refusing importation include non-compliance with labelling rules and for the protection of public health. Any person whose goods are seized is liable for any reasonable costs and expenses incurred by and charges due to the Commissioner General, in respect of the handling of and dealing with such goods. These laws are complemented by the Guidelines for Handling Confiscated Goods BOMRA/IL/IE/P05/G01.
According to the Medicines and Related Substances Act, any medicine imported, manufactured, or dispensed within Botswana must be labelled in accordance with such requirements as the Authority may prescribe. The Medicines and Related Substances Regulations of 2019, require the inclusion of any warnings or precautions that may be necessary or desirable on the labels of all medicines. The Guidelines for Import/Export of Medicines, 2020 - Document No: BOMRA/IL/IE/P02/G01 indicates the labelling requirements that must be adhered to.
The Medicines and Related Substances Act does not define feed business operator. However, actors involved in the production and distribution, including importing, and exporting of feed are to be licensed, as required by the Act. The preparation of premix must only be done at a feed mill authorised to manufacture medicated feed by the Authority acting in consultation with the Department of Veterinary Services. Similarly, no person operates a feed mill except in accordance with a license issued by the Department of Veterinary Services.
FEED EXPORT
Exportation of premix is regulated by the Medicines and Related Substances Act. The Medicines and Related Substances Regulations provide the procedure for applying for an export permit. The Regulations are complemented by the Guidelines for Import/Export of Medicines BOMRA/IL/IE/P02/G01. An application for an export permit must be made to the Medicines Regulatory Authority in the prescribed form. The export permit is valid for six months. The law does not provide that exports must be inspected prior to departure.
INSPECTION
The Medicines and Related Substances Act (MRSA) empowers the Medicines Regulatory Board to appoint inspectors to inspect pharmaceutical operations. Inspectors have the powers to inspect, with or without prior arrangement, all premises where medicines or medicated feeds are stored, used, handled, dispensed, manufactured or sold, and any vehicle, transhipment, or receptacle in which medicines are transported. The inspectors have the right to take samples of any medicines on the premises, without payment, and to carry out any investigation that the inspector considers necessary. They also have the right to demand any economic or statistical information from the licence holder and may seize medicines found on premises, a vehicle, transhipment, or receptacle where the medicines are held in contravention of the provisions of the Act.
Criminal sanctions for offences related to feed safety and quality regulation are prescribed. Specifically, operating an unauthorised feed mill carries a fine not exceeding P200 000, or to imprisonment for a term not exceeding three years, or both. Preparing premix at a mill unauthorised to manufacture medicated feed attracts a fine not exceeding P500 000 or to imprisonment for a term not exceeding three years, or both. To import, export, manufacture, distribute, sell, dispense, prescribe, or advertise any medicine or other substance which is unregistered attracts a fine of P100 000, or to imprisonment for 10 years, or both.
BOMRA which is established in terms of the Medicines and Related Substances Act is mainly responsible for implementing and managing requirements pertaining to production, distribution, import and export of animal feeds. Specifically, BOMRA must ensure that all medicines and related substances manufactures in, imported into, or exported from, Botswana are registered and conform to established criteria of quality, safety and efficacy. Also, it has to inspect or cause to be inspected, premises where medicated feeds are used, handled or stored.
BOMRA has the authority to suspend or revoke licenses. If BOMRA determines that a VMP retail operator is not operating according to professional standards, it can suspend the license temporarily, providing directions for compliance. If the non-compliance continues, the license may be cancelled. In such cases, the license holder is required to dispose of their stock within six months, following the approved guidelines set by the BOMRA. For manufacturing licenses, if the BOMRA finds that the conditions of the license are not being met, or if the manufacturing of medicines does not comply with the MRSA regulations or good practice standards, it can cancel the license after notifying the holder in writing. Once the license is cancelled, the holder must cease all manufacturing activities. Additionally, BOMRA has the power to revoke an import or export license if it determines that the medicine is being handled in a manner that violates the terms of the license. In such cases, a written notice will be issued to the importer, exporter, distributor, or seller, explaining the specific violation, and providing a 21-day grace period to rectify the situation. If the violation persists beyond the 21-day period, BOMRA may withdraw or suspend the license until the conditions set by it are met. Once the license is withdrawn or suspended, the importer, exporter, or distributor must immediately cease all activities related to the license.
Additionally, BOMRA has the power to revoke an import or export license if it determines that the medicine is being handled in a manner that violates the terms of the license. In such cases, a written notice will be issued to the importer, exporter, distributor, or seller, explaining the specific violation, and providing a 21-day grace period to rectify the situation. If the violation persists beyond the 21-day period, BOMRA may withdraw or suspend the license until the conditions set by it are met. Once the license is withdrawn or suspended, the importer, exporter, or distributor must immediately cease all activities related to the license.
It is considered an offense to supply medicines to an importer, exporter, distributor, dispenser, or seller whose license has been revoked. Those found guilty of this offense may face imprisonment of up to three years. Furthermore, if a license is withdrawn, an inspector may close the premises where the import, export, distribution, or sale of the medicine was taking place.
ANIMAL WELFARE
GENERAL REQUIREMENTS
The Cruelty of Animals Act, 1926 and the Livestock Control Bye-laws in all districts prohibits cruel treatment of animals. Similarly, the Wildlife Conservation and National Parks Act,1998 provides that when importing, exporting or transporting live animals, necessary steps must be taken to minimise the risk of injury, cruelty or damage to its health during transport or transhipment of the animal to its destination. The law prohibits activities such as cruelly beating, kicking, ill-treating, over-driving, over-riding, over-loading, or torturing any animal. The Department of Veterinary Services is generally responsible for domestic animal welfare, while the Department of Wildlife and National Park is responsible for the welfare of wildlife. Its field works include vaccination campaigns, treatments, clinical examinations, animal identification. Non-governmental organisation such as the Botswana Society for the Prevention of Cruelty to Animals (BSPCA) exists and is the main animal welfare organization in Botswana which undertakes a variety of practical welfare activities including kennels/sheltering, rehoming, veterinary care as well as humane education and responsible animal ownership. The Department of Veterinary Services collaborates with NGOs on issues of animal welfare. Criminal sanctions are imposed on offences related to animal welfare. The sanction is a fine not exceeding P50 or imprisonment for a term not exceeding six months, or both.
ANIMAL HUSBANDRY
Animal husbandry in Botswana is regulated by the Cruelty of Animal Act which makes provision for the prevention of cruelty to animals. The Cruelty of Animal Act lists activities that are prohibited and this include ill-treating, overriding, overloading any animal, using any animals which is diseased, or injured thereby causing pain suffering; and administrating poisonous or injurious drug or substance to any animal. Animals that are injured or ill must be treated promptly. If the animal is mortally injured or severely ill, the police officer may request the owner of the animal to destroy it, and should the owner refuse, an opinion of the veterinary surgeon must be sought to certify that the animal is mortally wounded or severely injured to warrant it being immediately slaughtered. The law grants a police officer power to enter premises where animals are kept for the purpose of examining the conditions under which they are so kept.
District Council Bye-laws mandate that all animals must be housed in environments that promote their well-being. The Councils may demolish any stable or similar structure that is deemed unsuitable for animals to live in. In accordance with the Public Health Act, any facility such as a stable, cowshed, or other construction used for housing animals or birds that is offensive, or poses a risk or harm to health, is classified as a public nuisance. Health officers may specify any work to be executed to remedy and prevent the recurrence of the nuisance.
TRANSPORTATION OF ANIMALS
The Cruelty of Animals Act imposes a general prohibition on transporting or conveying animals in such a manner to cause injury or undue suffering. Also, over-driving, over-riding, or over-loading is prohibited. Similarly, using or causing the use of any animal which is so diseased, or injured, or in such a physical condition that it is unfit to do any work, is prohibited. The Wildlife Conservation and National Parks Act prohibits the transportation of live wild animals in such a manner that causes injury or damage to the animal. Also, the Wildlife (Hunting and Licensing) Regulations, 2001 require that the equipment to be used for transportations of wild animals be kept in confinement has to be inspected. This is meant to ensure that, amongst other things, the transportation does not cause undue suffering or injury to the animal. In terms of the Disease of Animals Act, every owner or person in control of any animal affected or suspected of being affected by any disease is required by law to as far as is practicable, keep such animal separated from other animals not so affected.
STUNNING AND SLAUGHTER OF ANIMALS
The law does not define the following key terms: - "stunning", "killing", "slaughter", and "religious /ritual slaughter". With regards to religious/ritual slaughter, there are references to this form of slaughter without defining it. For instance, the Gaborone City Council (Abattoir) Bye-laws, 1971 refers to slaughtering under Jewish or Mohammedan rites to be executed and superintended by members of the Jewish or Mohammedan faith respectively but does not define the term religious slaughter.
The laws governing the stunning and slaughtering of animals are found in different regulations and bye-laws, including the Livestock and Meat Industries Regulations, 2007 and Council Bye-laws. These laws aim to prevent unnecessary suffering, pain, and distress during the slaughtering process. For instance, when slaughtering an animal, the head must be securely held or fastened to minimize pain and ensure a swift and humane procedure. Additionally, when conducting religious slaughter, individuals are required to use instruments, appliances, and methods that cause as little suffering as possible. These measures are in place to prioritize the welfare of animals during the slaughtering process.
The laws do not specify specific methods for slaughtering animals, except for the Gaborone City Council (Abattoir) Bye-Laws, 15, which recommend shooting as the preferred method. However, this requirement does not apply to the slaughter of animals for Mohammedans or Jews. The laws also place restrictions on how animals should be handled during the slaughtering process. Animals brought in for slaughter should not be kept in the lairage for more than 72 hours. According to the Northeast District (Abattoir) Bye-Laws, animals brought into abattoirs for slaughter must be treated with care and should not be subjected to any form of cruelty or unnecessary suffering. Veterinary surgeons are designated as the competent authority responsible for examining and seizing meat, as well as certifying fresh meat as safe for human consumption in slaughter facilities.
AQUACULTURE
AUTHORIZATIONS
Inland fisheries use wild fish from various water bodies, such as lakes, rivers, wetlands, and reservoirs. Aquaculture, on the other hand, involves the farming of aquatic organisms, including fish, molluscs, crustaceans, and aquatic plants, with the use of interventions to enhance production, such as regular stocking, feeding, and protection from predators. In Botswana, these activities are regulated and supervised by different laws and institutions.
Inland fishing is governed by the Wildlife Conservation and National Parks Act, 1992, Fish Protection Regulations, 2016, and Water Act, 1967. To engage in fishing activities for commercial and domestic purposes, a license must be obtained from the Director of Wildlife and National Parks. Furthermore, for capturing fish for breeding or farming purposes, a Director's permit under section 39 of the Wildlife Conservation and National Parks Act is required. Additionally, a water permit is necessary for damming, diverting, or using water for any non-domestic purposes. However, selling fish acquired through a commercial fishing license or recreational license does not require a selling permit.
MITIGATING ENVIRONMENTAL IMPACTS
The Environmental Assessment Regulations of 2012 provide legal provisions for aquaculture. Undertaking aquaculture requires a permit from the Department of Aquaculture and Apiculture in the Ministry of Agricultural Development and Food Security. However, to capture fish for breeding or fish farming purposes from any water body, a permit from the Director of Wildlife and National Parks is required. Under the Environmental Assessment Regulations, certain fish-farming production systems are required to undergo an Environmental Impact Assessment (EIA). An EIA is required for fish-farming production systems with a capacity of 4000 m3 or more, those that have a direct discharge into a water body, commercial fish farming ventures with an annual production of 20 tonnes or more, and fish farming production systems that use exotic species.
The restrictions upon the use of certain chemicals in aquaculture activities is overseen by the Conservation Committee established in terms of the Agricultural Resources Conservation Act. This committee's functions include persuading any owner or occupier of land in its area of jurisdiction to adopt such methods of farming or land use as it may deem necessary for the purpose of conserving soil fertility and protecting agricultural resources. Aquaculture is one of the agricultural activities and therefore the use of certain chemicals in aquaculture activities is regulated by this committee.
The law imposes criminal sanctions in case of offences related to environmental protection. Failure to undertake an environmental impact assessment is a criminal offence that attracts a fine of not exceeding P100 000, or imprisonment not exceeding five years, or both. Also, the person must rehabilitate the area affected by the adverse environmental impact of the implemented activity. Further, conservation committee may provide directions/ conservation orders to any person to preserve agricultural resources, and any who refuses or neglects to carry out or comply with any direction commits a criminal offence. The sanction is a fine not exceeding P1000 or imprisonment for a term not exceeding 12 months, or both.
INSTITUTIONAL FRAMEWORK RELEVANT TO ANIMAL PRODUCTION
INSTITUTIONAL SET-UP
The institutions relevant to animal production are the Department of Veterinary Services (DVS), Department of Animal Production, Department of Aquaculture and Apiculture, Department of Wildlife and National Parks, and Botswana Medicines Regulatory Authority (BOMRA). Currently, the DVS is the controlling authority for the purposes of animal production purposes. It has licensing and inspectorate/supervisory powers. The Director of DVS is responsible for licensing premises as abattoir, cutting premises, a cold store, a farmed game handling facility or a farmed game meat plan. Further, he may designate veterinary surgeons as Official Veterinary Surgeons (OVSs) and in relation to any premises, appoint one or more OVSs or meat inspectors, as authorised officers in relation to the examination and seizure of meat, and the certification of fresh meat as healthy for human consumption.
The DVS is also responsible for managing the animal identification and traceability system and enforcing the BAITS Regulations. DVS’s Director has the power to inspect any holdings, slaughterhouse, or abattoir in order to ensure compliance with laws and regulations. DVS is generally responsible for domestic animal welfare. It also licenses feed mills and collaborates with BOMRA on matters related to Veterinary Medical Products (VMPs), which includes animal feeds. BOMRA is primarily responsible for implementing and managing requirements related to the production, distribution, importation, and exportation of VMPs and animal feeds.
Inland fisheries and wildlife welfare is the responsibility of the Department of Wildlife and National Parks (DWNP), while the Department of Aquaculture and Apiculture is responsible for aquaculture. These Department have licensing and supervisory powers. The Department of Animal Production provides expert advice to livestock farmers on livestock improvement and product development in terms of breeding, nutrition, housing, processing and optimal use of rangelands The Livestock Improvement Act creates the Animal Production Advisory Board whose functions includes advising the Minister on matters concerning the development and improvement of the livestock industry and the development of farmed game. The Minister is empowered to appoint an animal scientist from the Department of Animal Production as Registrar. The Registrar serves as Secretary to the Animal Production Advisory Board and is responsible for maintaining a record of the Board’s discussions and decisions. The Minister or Registrar grants approvals to laboratories to carry out the blood typing, analytical or diagnostic tests; performance testing or genetic evaluation of breeding animals; and to any person who wants to be engaged or employed as a centre animal scientist or is engaged in any of the activities of a semen, ova/embryo collection centre or an artificial insemination centre.
However, the roles of all the aforementioned institutions will be affected by the envisaged new legislation, the Botswana Meat Industry Regulatory Authority (BMIRA) Act of 2023, which is not yet in force. This Act will create the Botswana Meat Industry Regulatory Authority that will assume most of the roles currently held by DAP and DVS. The Board of the Authority which will be governing body of the Authority will assume the responsibilities of the Animal Production Advisory Board. The Agricultural Resources Conservation Act, 1972 provides for structures relating to conservation, use and improvement of agricultural resources, including animal husbandry. It defines agricultural resources to include "the animal life and fauna of Botswana including animals, birds, reptiles, fish and insects and establishes the Agricultural Resources Board, which supervises over the agricultural resources of Botswana and advises the Minister regarding, amongst other things, the nature of legislation necessary to secure or promote the proper conservation, use and improvement of agricultural resources. It may also issue conservation orders and stock control orders. While the law does not explicitly state the criteria according to which powers should be exercised, the requirements to indicate reasons for revoking licenses and reporting and publication of notices promotes principles of accountability and transparency.
The District Councils have a vital role in animal production at the local level. Their primary responsibilities include promoting animal welfare and enforcing bye-laws. They are authorized to establish, maintain, and operate abattoirs, as well as set reasonable fees, charges, and tariffs through bye-laws. These charges may cover services such as the inspection of carcasses.
The Ombudsman Act establishes the office of the Ombudsman, responsible for investigating complaints against governmental departments and private entities. Their key role is to provide suitable remedies to address these complaints. Furthermore, the Public Services Act allows for disciplinary hearings to be held for government employees involved in misconduct, with potential penalties including dismissal.
INSTITUTIONAL COOPERATION AND COORDINATION
The Department of Animal Production (DAP) and Department of Veterinary Services (DVS) collaborates in the provision and operation of quarantine facilities, veterinary services, and the licensing of abattoirs. Likewise, BOMRA and DVS engage in collaborative efforts regarding the licensing of feed mills. Additionally, BOMRA works in collaboration with BURS and the Department of Health Services to facilitate the importation and exportation of VMPs. At local level, the District Councils collaborates with DAP and DVS in the implementation of bye-laws. Further collaborations are witnessed in to prevent any overlapping of responsibilities, the law defines the specific functions of each institution and establishes points of coordination.
DELEGATION OF POWERS
The Medicines Regulatory Board, which oversees the operations of BOMRA, has the authority to delegate its powers, functions, or duties to a designated committee. Similarly, the Directors of DVS, DWNP, and DAP can delegate their powers to individuals. The Agricultural Conservation Board can delegate its supervisory functions over agricultural resources including animal husbandry to any person. At a local level, a Council has the discretion to delegate its functions to various bodies, trusts, or organizations in accordance with government policies. The Council also can amend or revoke any delegation made under this provision, and may impose conditions, including specific directions, on the exercise of any delegated power.
The Animal Production Advisory Board is empowered to appoint committees for general of specified functions, and delegate to such committees its powers. The committees may deal with issues such as those concerning the collection and distribution of semen, ova and embryos and any other techniques for genetic improvement. Further, the Act empowers the Registrar to delegate any of his/her functions to an officer. A decision made or order given by an officer delegated by the Registrar shall, until it has been so withdrawn or amended, be considered to have been made or given by the Registrar.