AGROCHEMICALS: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
(under section 31)
(8th August, 2003)
ARRANGEMENT OF REGULATIONS
REGULATION
1. Citation
2. Interpretation
3. Application to register an agrochemical
4. Registration
5. Other applications
6. Labelling
7. Duty of licensee
8. Promotion and advertisement
9. Record keeping by licensee
10. Storage
11. Safe handling
12. Disposal of waste
13. Training course
14. Offence and penalty
First Schedule
Second Schedule
Third Schedule
Fourth Schedule
Fifth Schedule
S.I. 37, 2003,
S.I. 36, 2005.
These Regulations may be cited as the Agrochemicals Regulations.
In these Regulations, unless the context otherwise requires, "licensee" means a holder of a licence issued under these Regulations.
3. Application to register an agrochemical
(1) A person may make an application to register an agrochemical in accordance with section 12 of the Act and with the provisions of subregulation (2).
(2) An application under subsection (1) shall be made to the Registrar in Form 1 set out in the First Schedule and shall further be accompanied by—
(a) two samples of the agrochemical;
(b) any advertising material or experimental data in support of efficacy of the agrochemical;
(c) full toxicological data of the agrochemical;
(d) methods of analysis of the agrochemical; and
(e) residue and phytotoxicity data of the agrochemical under Botswana or similar conditions.
(f) a fee of P500.
(2A) An application for the renewal of the registration of an agrochemical shall be made to the Registrar in Form 1 set out in the First Schedule and shall be accompanied by a fee of P250.
(2B) There shall be charged a fee of P300 for late renewal of registration of an agrochemical.
(3) Where an applicant is only seeking registration for the sale of an agrochemical and the manufacturer of the agrochemical is not prepared to give the applicant information about such agrochemical, the manufacturer shall submit the full composition statement of such agrochemical directly to the Registrar.
(1) The Registrar shall, where he is satisfied that an application meets the requirements of regulation 3, register the agrochemical and issue a registration certificate, as set out in the Second Schedule, to the applicant.
(2) Where the Registrar is not satisfied that the application meets the requirements of regulation 3, he shall reject the application and notify the applicant thereof in writing, stating the reasons for the rejection.
(1) An application for—
(a) a temporary import permit shall be in Form 2 and accompanied by a fee of P100;
(b) a permit for the import of an agrochemical for research or experimental purposes shall be in Form 3;
(c) a licence to facilitate the transit of an agrochemical from one country to another country shall be in Form 4 and accompanied by a fee of P200;
(d) a licence to dispose of an agrochemical and its by-products shall be in Form 5 and accompanied by a fee of P200;
(e) a licence to manufacture an agrochemical shall be in Form 6 and accompanied by a fee of P200;
(f) a licence to import, sell or distribute an agrochemical shall be in Form 7 and accompanied by a fee of P200; and
(g) a licence to commercially use an agrochemical shall be in Form 8 and accompanied by a fee of P200.
(2) Where the Registrar is satisfied that an application made in accordance with subregulation (1) meets the requirements of section 16 of the Act and of these Regulations, he shall—
(a) issue a permit as set out in Form 9; or
(b) issue a licence as set out in Form 10;
to the applicant, under such terms and conditions as he may consider appropriate.
(3) Where the Registrar is not satisfied that the application meets the requirements of section 16 and of these Regulations, he shall reject the application thereof in writing, stating the reasons for rejection.
(1) All containers in which an agrochemical is offered for sale or distribution shall bear a label written in English, and where possible, in Setswana, firmly affixed to the container, the wording of which shall be approved by the Committee.
(2) An application for the approval of the words to be placed on a label in accordance with subregulation (1) shall be made to the Committee in writing.
(3) A label in accordance with subregulation (1) shall contain the information set out in the Third Schedule.
(4) The classification of an agrochemical on a label according to toxicity shall be in accordance with the Fourth Schedule.
(5) The codes to be used for an agrochemical formulation on a label shall be as set out in the Fifth Schedule.
A licensee shall ensure that—
(a) an agrochemical distributed by him is approved, marked, packed and labelled in accordance with the provisions of these Regulations;
(b) the substance contained in an agrochemical distributed by him is in accordance with the specification on the label; and
(c) direction for use and other information printed on the label do not contain misleading or erroneous information.
8. Promotion and advertisement
(1) No person shall issue an advertisement of an agrochemical unless the advertisement has been approved by the Registrar.
(2) The Registrar shall not allow an advertisement that—
(a) uses words or phrases calculated to lead a purchaser to believe that registration or licensing implies special approval or official guarantee of the efficacy of the agrochemical; or
(b) makes claims other than those on a label made in accordance with regulation 6.
A record concerning the importation, manufacture, distribution or sale of an agrochemical maintained in accordance with section 28 of the Act shall contain the following information regarding the agrochemical—
(a) common name;
(b) trade name;
(c) chemical group;
(d) type of formulation;
(e) quantity of the product;
(f) date of manufacture;
(g) expiry date;
(h) toxicity class;
(i) quantity of obsolete chemicals;
(j) intended use;
(k) number of employees; and
(l) training level of employees.
(1) The licensee shall—
(a) ensure that the storage area of an agrochemical—
(i) is kept locked when the licensee or those of his employees handling the agrochemical are absent;
(ii) is well ventilated to prevent the build up of toxic vapours;
(iii) has suitable and adequate fire extinguishers that are easily accessible from outside, and
(iv) has warning signs posted in a conspicuous place, warning people of the dangers of the agrochemical stored inside;
(b) regularly inspect for leaks, any container in which an agrochemical is stored; and
(c) where an agrochemical container is damaged, transfer the agrochemical to a suitable, clean and compatible container and shall label the new container in accordance with these Regulations.
(1) An employer handling an agrochemical shall—
(a) ensure that his employees are medically examined periodically, to ensure that the employees are fit for work involving exposure to the agrochemical;
(b) provide those of his employees handling the agrochemical with appropriate protective clothing, which clothing shall be thoroughly washed at the workplace at the end of each day or operation, particularly when heavily contaminated;
(c) keep and maintain a works exposure record card for each employee handling the agrochemical; and
(d) at all times keep a first aid kit at hand where the agrochemical is manufactured, transported, handled or disposed.
(2) A works exposure record card kept in accordance with subparagraph 1(c) shall provide the following—
(a) the name and address of the employee;
(b) the exposure period of the employee;
(c) the common names of the active ingredient being handled;
(d) the physical state of the formulation of the agrochemical being handled;
(e) details of any occupational accidents involving the employee during the period of exposure;
(f) the date and nature of each case of poisoning; and
(g) a medical practitioners' notes regarding subregulation (2)(e) and (f).
(3) The employer shall, where an employee falls ill or is involved in an accident at the work place or in the course of discharging his duties as an employee, hand to a medical practitioner who examines the employee, the employee's works exposure record card kept under this regulation.
(1) No person shall—
(a) dump an agrochemical container indiscriminately; or
(b) put an agrochemical into food containers.
(2) A licensee shall ensure that—
(a) cartons, boxes and bags used to carry an agrochemical are shredded to avoid re-use;
(b) agrochemical waste is packed in plastic bags to minimise the risk of exposure during handling;
(c) pallets contaminated by an agrochemical are broken up;
(d) disposal of lightly agrochemical contaminated waste is carried out by—
(i) burning in an incinerator or in a hot fire in an isolated area down wind of the nearest habitation,
(ii) burial in an approved landfill, or
(iii) packing in strong polyethylene bags or 200 litres steel drums for disposal as toxic waste; and
(e) containers that were used to carry an agrochemical are—
(i) well drained, thoroughly rinsed with water or any other appropriate solvent such as diesel fuel then shredded or crushed, or
(ii) returned to the supplier or retained as spares to re-pack the same agrochemical it previously contained or agrochemical contaminated spill.
(1) The Registrar shall regularly conduct a training course for any person who applies for a licence under these Regulations and does not have relevant qualifications.
(2) A course in accordance with subregulation (1) shall cover the following topics—
(a) interpreting a label;
(b) groups of agrochemicals;
(c) toxicity classes and colour codes;
(d) storage and handling of different types of agrochemicals and agrochemicals with different toxicities;
(e) use of protective clothing; and
(f) disposal techniques of agrochemicals.
A person who contravenes any provision of these Regulations shall be guilty of an offence and liable to a fine not exceeding P500 or to imprisonment for a term not exceeding 6 months, or to both.
FIRST SCHEDULE
Form 1
APPLICATION FOR THE REGISTRATION OF AN AGROCHEMICAL
(reg. 3(2))
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Information for Applicants |
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1. Please complete all sections fully. Where applicable the required information should be submitted as attachments. |
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2. The application and product label must be submitted in triplicate. |
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3. The application must be accompanied by written authority from the manufacturer/formulator. |
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4. One copy of supportive studies required (e. g toxicological data, efficacy data, residue data, physical specifications etc) Refer to lists I and II attached. |
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5. Every application must be accompanied by the prescribed registration fees. |
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6. The application must be submitted to the Registrar of Agrochemicals, Private Bag 0091, Gaborone, Botswana. |
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Indicate where appropriate: |
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A. |
Agrochemical containing a new active ingredient: |
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B. |
Agrochemical where source of active and/or formulation is not identical to that of a registered product: |
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C. |
Registration transfer: |
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D. |
Amendments to an existing registration: |
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E. |
Other: |
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1. |
APPLICANT |
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1.1 |
Identification |
Name/Corporate name of company Reg. no.: |
Name of distributor/agent in Botswana: (if different from registration holder) |
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1.2 |
Status: |
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(Importer/formulator/ distributor) |
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1.3 |
Physical Address: |
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1.4 |
Postal Address: |
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1.5 |
Telephone: |
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1.6 |
Fax: |
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1.7 |
e-Mail: |
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2. |
PRODUCT |
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2.1 |
Designation |
Trade name: |
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Trade mark: |
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Trade mark holder: |
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2.2 |
Function of product (e.g insecticide, herbicide, |
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2.3 |
Intended use: (veterinary, agriculture, forestry, public health etc) |
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2.4 |
Target pest(s) and host(s): |
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2.5 |
Method, dosage rates and frequency of application: |
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2.6 |
Type of formulation: |
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Crop Life International/ |
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2.7 |
Existing reg. no.: |
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Customs Tariff Code: (Brussels Tariff Nomenclature) |
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2.8 |
Registration in SEARCH country/ies: |
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2.9 |
Registration in other country/ies: |
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2.10 |
Is the product registered in country of manufacture and formulation: |
If not, |
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If yes, submit evidence: |
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3. ACTIVE INGREDIENT(S) (Technical grade) (may be attached in sealed envelope) |
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Active ingredient(s): |
Manufacturer: |
Min a.i. % purity: |
Range %: |
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4. |
FORMULATION (may be attached in sealed envelope) |
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4.1 |
Formulator: (Name) |
Address: |
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4.2 |
Composition (may be attached in sealed envelope) |
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Ingredients and Function (e.g emulsifier) |
g/l |
g/kg |
Range |
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5. |
TOXICOLOGY (formulated product) |
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5.1 |
RAT: |
Acute Oral |
Acute Dermal |
Inhalation LC50 |
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Experimental
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Experimental |
Experimental |
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Calculated
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Calculated |
Calculated |
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5.2 |
RABBIT: |
Skin irritation |
Eye irritation |
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None |
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Mild |
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Moderate |
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Severe |
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5.3 |
Sensitisation in guinea pig: |
None |
Mild |
Moderate |
Severe |
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5.4 |
WHO class: |
Ia |
Ib |
II |
III |
IV |
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5.5 |
Summary of other Mammalian Toxicological Studies:
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5.6 |
Summary of Environmental Effects: |
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5.6.1 |
Toxicity to bees: |
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5.6.2 |
Toxicity to fish and other aquatic organisms: |
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5.6.3 |
Toxicity to birds: |
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5.6.4 |
Toxicity to earthworms and soil micro organisms: |
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5.6.5 |
Toxicity to other non-target organisms: |
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5.6.6 |
Persistence in environment: |
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5.6.7 |
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