Guide to registration of biological control agents

Transcription

1 Guide to registration of biological control agents Environmental Protection Agency Ghana

2 Published by the Environmental Protection Agency Ministries area, Accra October Edition 1.0 EPA 2011 Acknowledgement This document is an output from the Research into Use Programme, funded by the UK Department for International Development (DFID) for the benefit of developing countries. The views expressed are not necessarily those of DFID.

3 Contents The Environmental Protection Agency 5 What are biopesticides? Microbial pesticides 6 Biochemical pesticides 6 Plant extracts 6 Plant-incorporated protectants 6 Advantages of biopesticides 7 How to register a bio-pesticide Scope 8 Definitions 8 Submission of the dossier General principles 10 Presentation of annexes 10 Contents of the application Types of application 11 List of required and optional annexes 12 Page A Information about the applicant and the product Section 1 Identification 13 Section 2 Designation 13 Section 3 Composition 14 Section 4 Product origin 15 Section 5 Product use 16 Section 6 Product registration 18 Page B Formulation features Section 7 Product formulation 19 Section 8 Toxicology 21 Section 9 Emergency measures / accident and fire 24 Section 10 Labelling 25 Section 11 Packaging 27 Page C Trials Section 12 Site 29 Section 13 Object 29 Section 14 Layout 30 Section 15 Treatments 31 Section 16 Observations and results 32 Section 17 Assessment 32 Page D Active ingredient Section 18 Designation 33 Section 19 Physiological, physical and chemical properties 33 Section 20 Purity 37 Section 21 Toxicology 37 Section 22 Plant residues 41 Section 23 Ecotoxicity 43 Section 24 Action on the environment 46 Appendix 1 Risk phrases 48 Appendix 2 Safety phrases 51 Appendix 3 Pictograms 53 Appendix 4 Acronyms 54

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5 The Environmental Protection Agency and its work The Government of Ghana has set a clear goal to establish the country among the middle ranking developed nations within the next two decades. This goal is to be achieved through development based upon the sustainable use of the country s natural resources and through the application of its single most valuable resource - the nation s people. This Vision for Ghana clearly recognises that environmental protection and successful development are fundamentally interdependent. A healthy environment is essential if development is to be sustainable and its benefits enjoyed by both the present and future generations. Similarly without properly planned and implemented development, many people will continue to live in poverty, pressure on the environment will grow and degradation of the environment will continue. We have a key role to play in helping the nation achieve the goal of sustainable development. This role is reflected in both our vision for the environment and ourselves. Since our establishment in late 1994, we have laid the foundation for achieving this vision. The Ghana Environmental Resources Management Project (GERMP) has been particularly important in enabling us to develop our institutional capacity, to strengthen our presence at regional level, to train our staff and to develop the scope and quality of key environmental databases. The future will be critical for us as we build upon the success of the GERMP and further develop our capacity to implement environmental protection programmes in partnership with the Ghanaian community. The key to our success in achieving our vision for the environment lies in our ability: to raise the awareness of people throughout Ghana of the importance of protecting and enhancing their environment to facilitate the transfer of knowledge of what can be done to gain the commitment of people and institutions to change behaviour and avoid actions which degrade the environment to help empower people to take practical action at all levels of society. To do this we will employ a broad range of strategies and tools to influence and change environmental attitudes and behaviour including: educating and informing, advising and assisting and, where necessary, directing and enforcing. As a relatively small agency of Government, we will act as a catalyst for beneficial change, working through a complex web of partnerships at national, regional, district and local levels. Page 5

6 What are biopesticides? Biopesticides are certain types of pesticides derived from such natural materials, primarily microbes, but can also be originally from animals, plants, and certain minerals. Biopesticides fall into four major groups: Microbial pesticides These consist of a microorganism (eg a bacterium, fungus, virus or protozoan) as the active ingredient. Microbial pesticides can control many different kinds of pests, although each separate active ingredient is relatively specific for its target pest(s). For example, there are fungi that control certain weeds, and other fungi that kill specific insects. The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different mix of toxic proteins, and specifically kills one or a few related species of insect larvae. While some Bts control moth larvae found on plants, other Bts are specific for larvae of flies and mosquitoes. The target insect species are determined by whether the particular Bt produces a protein that can bind to a larval gut receptor, destroying the cells of the gut and thereby causing the insect larvae to starve. Registering microbials as biopesticides must take special account of their properties and this can be specifically factors like pathogenicity/infectivity in humans and animals, sensitisation of users, the production of toxins and the potential for multiplication in the environment. Biochemical pesticides Plant extracts Plant-incorporated protectants Biochemical pesticides are naturally occurring substances that control pests by non-toxic mechanisms. Conventional pesticides, by contrast, are generally synthetic materials that directly kill or inactivate the pest. Biochemical pesticides include substances, such as insect sex pheromones, that interfere with mating, as well as various scented plant extracts that attract insect pests to traps. Guidance on requirements for pheromones and other semiochemicals can be found in Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD Series on Pesticides, number 12). There is a large spectrum of plant extracts, ie unprocessed extracts representing a cluster of substances or highly refined products containing one active substance. In addition the risk associated with the use of plant extracts may vary between low and very high risk, depending upon the toxicity of the chemical components in the extract. For this reason they are assessed on a case by case basis. An example of a plant extract is neem based products. Where genetically modified plant material is allowed, such as in the USA, then Plant-Incorporated-Protectants (PIPs) are considered as biopesticides. PIPs are pesticidal substances that plants produce from genetic material that has been added to the plant. For example, scientists can take the gene for the Bt pesticidal protein, and introduce the gene into the plant s own genetic material. Then the plant, instead of the Bt bacterium, manufactures the substance that destroys the pest. The protein and its genetic material, but not the plant itself, are regulated by EPA in the USA. Page 6

7 Advantages of biopesticides Usually inherently less toxic than conventional pesticides. Generally affect only the target pest and closely related organisms, in contrast to broad spectrum, conventional pesticides that may affect organisms as different as birds, insects, and mammals. Often are effective in very small quantities and often decompose quickly, thereby resulting in lower exposures and largely avoiding the pollution problems caused by conventional pesticides. When used as a component of Integrated Pest Management (IPM) programs, biopesticides can greatly decrease the use of conventional pesticides, while crop yields remain high. Page 7

8 How to register a bio-pesticide This guide is intended for operators in the pesticides market who want to complete an application form for the registration of a new microbial pesticide. Making the application for registration in the correct way, and with all required information, will speed the application process. Scope These are the biochemical product categories that can be considered for registration as bio-pesticides: Semiochemicals derived from plants and animals and other organisms Botanical extracts Definitions The following definitions are used in this guide Botanical extracts are plant protection products which may contain plants, plant extracts and possibly formulants. The plants used in plant protection products in the framework of this document are live or dried plants or parts of plants, including fruits and seeds, but excluding genetically modified plants. Semiochemicals (SC) are chemicals emitted by plants, animals, and other organisms - and synthetic analogues of such substances - that evoke a behavioural or physiological response in individuals of the same or other species. They include pheromones and allelochemicals. Semiochemicals intended for use only as pest monitoring tools do not require registration. Allelochemicals are semiochemicals produced by individuals of one species that modify the behaviour of individuals of a different species (ie an interspecific effect). They include allomones (emitting species benefits), kairomones (receptor species benefits) and synomones (both species benefit). Pheromones are semiochemicals produced by individuals of a species that modify the behaviour of other individuals of the same species (ie an intraspecific effect). Straight-chained lepidopteran pheromones (SCLPs) are a group of pheromones consisting of unbranched aliphatics having a chain of nine to eighteen carbons, containing up to three double bonds, ending in an alcohol, acetate or aldehyde functional group. This structural definition encompasses the majority of known pheromones produced by insects in the order Lepidoptera, which includes butterflies and moths. Page 8

9 Submission of the dossier The dossier - comprising the application form and annexes - is provided in two copies in the official language of the addressee country. The applicant is responsible of the content of the dossier. On completion, send the application dossier to the Chemicals Control and Management Centre (CCMC), addressed to the Pesticide Registrar. Acknowledgement of receipt From reception of the dossier, a registration specialist records the dossier and proceeds to the verification of its content. The applicant is then informed of the admissibility of its application by a normalized acknowledgement of receipt. The registration specialist ensures the follow up of the dossier until the application is considered by sub-committees and finally at a session of the Pesticides Technical Committee (PTC). Decision The Pesticides Technical Committee reviews recommendations from the three sub-committees: human toxicology / ecotoxicology sub-committee labelling and advertisement sub-committee bio-efficacy sub-committee It then makes recommendations for consideration by the EPA Board. The decision to register or refuse registration is made by the EPA Board and the applicants are informed accordingly. Page 9

10 Contents of the application The completed application consists of a dossier, by which we mean a file of documents comprised of the completed Application Form plus a variable number of attachments and annexes. The number of annexes is a function of the type of application being made. General principles Application forms must be completed in English. Two copies of the completed forms plus attachments must be supplied. Note that for some types of submissions, parts of the form are completed several times (for each active ingredient, for example). Two copies of each repeated part of the application are required. All the white boxes on the form have to be filled in, no boxes should be left blank. There are four possibilities to fill a box: Response types You want to give a numerical value in response to this question You want to give a text value in response to this question The information requested for this box does not apply to yourself or your product The information requested for this box is not available Response given : 251 mg/kg : Not mutagenic Please write Not applicable Please write Not available When a box does not contain one of the above types of contents, the information will be considered as missing. We will tell you this in our acknowledgement and your application will not proceed until the missing information is supplied. We will only accept results obtained by using CIPAC, EU, or OECD methods, or any other international and approved standard methods. Presentation of annexes Please tell us that you have included attachments to your application form by ticking the appropriate white boxes in the right margin of the form. A cover page must be included of every attachment and be physically attached to the annex it refers to. The cover page must show the following: a title (for example: Analysis, Label design ) the section and annex number relative to the application the name of the product that is the subject of the application the active ingredient(s) contained in the product of a title page for an annex Title: Label design Number: Section 10 annex 8 Product name: MyProductName Active substance: Bacyllus XXX Page 10

11 Types of application There are five types of application that can be made. The information required in the Application Form, and the type of attachments that must be submitted for each type of application is shown in the table on the following page. For all types of application except Renewal, pages C and D of the form must be copied and completed as many times as there are active ingredients in the application. Provisional clearance Provisional clearance means that the product is approved for use for a defined period, typically a number of months, during which further steps as required by EPA are carried out. Full registration Full registration confers on the applicant the right to market the product for a defined period. Renewal of registration When a registration lapses or expires, an application for renewal must be made in order to continue to sell or use the product. Composition modification Application to change the composition of a formulation that is already registered. Extension of use A product registered for one crop can be extended for use on to other crops by providing an efficacy trial report on the new crop or crop groupings. Page 11

12 List of required and optional annexes This table shows the required contents of each type of application. Page Section A 01 Identification = = = = = 02 Designation = = = = = 03 Composition = = = = = Annex 1 Analysis report = = = Annex 2 Complete composition in sealed envelope = = = 04 Origin = = = = = Annex 3 Original certificates = = = = 05 Use = = = = = Annex 4 Technical leaflet = = = = = 06 Registrations = = = = Annex 5 Registration certificates = = = = Provisional clearance Full registration Renewal of registration Extended use B 07 Physical and chemical properties = = = 08 Toxicology = = = Annex 6 Safety data sheet = = = 09 Emergency measures for accident or fire = = = 10 Labelling = = = = = Annex 7 Label pattern = = = = = 11 Packaging = = = = = Annex 8 Packaging specifications = = = = = C 12 Site of trial = = = = 13 Object = = = = 14 Layout = = = = Annex 9 Experimental protocol = = = = 15 Treatments = = = = 16 Observations and results = = = = Annex 10 Trial report = = = = 17 Assessment of the trial = = = = D 18 Designation of the active ingredient = = = 19 Physical and chemical properties = = = 20 Purity = = = 21 Toxicology of the active ingredient = = = Annex 11 Summary of the toxicological dossier = = = Annex 12 Other studies < < < 22 Residues in the plant = = = = Annex 13 Summary of the residue dossier = = = = 23 Ecotoxicology of the active ingredient = = = Annex 14 Summary of the ecotoxicological dossier = = = Annexe 15 Other studies < < < 24 Behaviour in the environment = = = Annex 16 Summary of environmental studies = = = Annex 17 Other studies < < < =mandatory <optional Composition modification Page 12

13 Page A Information about the applicant and the product Application type First, tick one box only from the list of possible application types, indicating if this is to be an application for Full registration or a different type. Section 1 Identification 1.1 Name or corporate name The applicant named in this box should be the supplier of the product, and his representative, who is registered to do business in Ghana. He is responsible for the commercialisation of the product when it is registered. 1.2 Contact details Give the permanent address of the applicant. It must be a geographically identifiable address, and giving the PO Box is not sufficient. Give the name, position in the organisation, telephone/fax number and the address of the person to contact. 1.3 Name, signature and seal of the applicant Put the name and business registration number of the applicant in the white box. The signature indicates that the applicant certifies the accuracy in every respect of the information given on the form. The seal of the organisation should also be applied. Section 2 Designation 2.1 Commercial name / trade name Put the commercial name (trade name) of the product into the box. This name must be different from all registered trademarks in Ghana. 2.2 Product function Select one or more of the functions in the list below. If you select Other please indicate a use as described by the World Health Organisation in publication WHO/PCS/94.2 miticide herbicide chemical mediator (floral induction, growth regulation, maturation regulation, chemical thinning out) fungicide nematicide insecticide rodenticide molluscicide virucide repulsive bactericide molecide other 2.3 Formulation type and code Select one of the formulation types from the list below and enter it and the code into the box provided. AB Grain bait KL Combi-pack liquid/liquid AE Aerosol dispenser KN Cold fogging concentrate AI Active ingredient KP Combi-pack solid/solid AL Other liquid to be applied LA Lacquer undiluted BB Block bait LS Solution for seed treatment BR Briquette MG Microgranule CB Bait concentrate OF Oil miscible flowable concentrate (oil miscible suspension) CG Encapsulated granule OL oil miscible liquid CS Capsule suspension OP Oil dispersible powder Page 13

14 DC Dispersible concentrate PA Paste DP Dustable powder PB Plate bait DS Powder for dry seed treatment PC Gel or paste concentrate EC Emulsifiable concentrate PR Plan rodlet ED Electrochargeable liquid PS Seed coated with a pesticide EO Emulsion, water in oil RB Bait (ready for use) ES Emulsion for seed treatment SB Scrap bait EW Emulsion, oil in water SC Suspension concentrate (flowable concentrate) FD Smoke tin SE Suspo-emulsion FG Fine granule SG Water soluble granules FK Smoke candle SL Soluble concentrate FP Smoke cartridge SO Spreading oil FR Smoke rodlet SP Water soluble powder FS Flowable concentrate for seed treatment SS Water soluble powder for seed treatment FT Smoke tablet SU Ultra low volume (ULV) suspension FU Smoke generator TB Tablet FW Smoke pellet TC Technical material GA Gas TK Technical concentrate GB Granular bait TP Tracking powder GE Gas generating product UL Ultra low volume (ULV) liquid GG Macrogranule VP Vapour releasing product GP Flo-dust WG Water dispersible granules GR Granule WP Wettable powder GS Grease WS Water dispersible powder for slurry treatment HN Hot fogging concentrate XX Other KK Combi-pack solid/liquid If you select Other, please describe the physical nature and the type of formulation, and a proposed name for the formulation. Section 3 Composition 3.1 Analysis report Attach the laboratory analysis of the composition of the product to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording Analysis report; Section 3 Annex 1 Only analysis reports performed by an EPA approved laboratory will be considered. The analysis report must show the method of analysis of the formulated product and the active ingredient, and absorption spectrums (ultraviolet, visible and infrared). 3.2 Composition You must provide a list of the complete composition of the product (active ingredient, adjuvants, etc), with a cover page marked as Title: Composition; Annex Section 3 Annex 2 (see page 10 for full annex marking information) Place the list in a sealed envelope, similarly marked, and include with the application form. Page 14

15 3.3 Active ingredient (AI) The active ingredient(s) should be named by their scientific/systematic name/s as internationally adopted. The scientific name should include taxonomic grouping ie family, genus, species, strain, sereotype or any other relevant denomination. If the active ingredient is a microorganism, state the internationally recognised accession number or accession number at a recognized culture collection in Ghana. Each microorganism should be identified and named to the species level. State whether the microorganism is indigenous or non-indigenous at the species level to Ghana. 3.4 Manufacturer Give the name and full address of the supplier of each active ingredient. 3.5 Grade Give the guaranteed grade of each active ingredient in the formulation. Values should specify % purity and the range of active ingredient. Guarantee content at 25 Range of active ingredient Liquid Solid Up to 25 g/l Up to 2.5% ±15% of the guarantee content for homogenous formulations (SL, EC, SC etc) ±15% of the guarantee content for non-homogenous formulations (GR, WG) 25 to 100 g/l 2.5 to 10% ±10% of the guarantee content 100 to 250 g/l 10 to 25% ±6% of the guarantee content 250 to 500 g/l 25 to 50% ±5% of the guarantee content Over 500 g/l Over 50% ±25g/l of the liquid formulation ±25%g/kg of the solid formulation Section 4 Product origin 4.1 Formulation manufacturer Give the name and the address of the manufacturer of the formulation (give the physical location - the mention of a PO Box is not sufficient), as well as the name, organisational position, telephone and fax numbers, and address of the contact person. 4.2 Active substance manufacturer Give the name of the manufacturer of each active ingredient (repeat the information as stated in Section 3 - Composition), and corresponding address (give the physical location - the mention of a PO Box is not sufficient), as well as the name, organisational position, telephone and fax numbers, and address of the contact person. 4.3 Original certificates Provide certified copies (from a commissioner of oaths or an advocate or equivalent) of the original certificates of each active ingredient. Attach these to the application as an annex, with a cover page marked Title: Original certificates, Section 4 Annex 3 (see page 10 for full annex marking information) 4.4 Trademark owner Give the name and the address (give the physical location - the mention of a PO Box is not sufficient) of the owner of the trademark, as well as the name, Page 15

16 organisational position, telephone and fax numbers, and address of the contact person. Section 5 Product use 5.1 Annex 4 -Technical leaflet Attach a complete and easily comprehensible copy of the technical leaflet of the formulated product prepared by the manufacturer. Provide a cover marked Title: technical leaflet, Section 5 Annex 4 as described on page 10.) 5.2 Intended use Here you should give the intended use of the product eg veterinary, horticultural, public health, industrial, agricultural, forestry, etc. Also give the directions for use: the application rate (see section 5.4), method of application and recommended number and timing of applications. 5.3 Target organism If the target is a pest, disease or weed, the organism(s) for which the active ingredient is targeted have to be identified by their common names and their scientific names up to species and sub-species. 5.4 Dosage Here you give the dosage rate and frequency of application, which must be expressed in the units as given in this table (all other units will be considered as inappropriate by the PTC: Use Formulation Active ingredient Watering and soaking of plants and seeds solid formulations solutions, suspensions and emulsions g/hl g/hl g/ha g/ha Solid baits solid formulations liquid formulations. Fumigants formulated as liquids or gases stocked commodities and seeds premises soil Spraying premises treatments outdoor treatments g/kg of bait l/kg of bait l/q g/m 3 l/ha g/kg of bait g/kg of bait g/q g/m 3 g/ha l/m 3 l/ha g/m 3 g/ha Powdering and coating of seeds g/q g/q Powdering of stocked commodities g/q g/q Powdering and flo-dust g/ha g/ha Spraying in premises and on packaging solid formulations liquid formulations g/m 2 l/m 2 g/m 2 g/m 2 Spraying on seeds and stocked commodities l/q g/q Spraying at low volume and ultra low volume l/ha g/ha Spraying at normal volume solutions, suspensions and emulsions. l/ha g/ha 5.5 Stage of treatment or pre-harvest interval In this section, please specify one of the following: Page 16 the stage of growth of the target organism or

17 the time when the formulation has to be applied or the pre-harvest interval The pre-harvest interval is the time between the application and any of the following: the access of human beings or animals to the treated area or crop the harvesting, use or consumption of the produce s Re-entry interval: 1 day Pre-harvest interval: 5 days 5.6 Mode of action Please indicate the mode of action of the product on its target(s). It is probable that this information will be too large to write on the form, in which case summarise in the box provided and add supporting evidence to the dossier as an annex. If the microorganism/active ingredient produces a toxin with a residual effect on the target organism, describe the following: the mode of action of the toxin the site of infection the mode of entry the susceptible stage of the action the means of uptake of the microorganism or its metabolites (especially toxins) eg contact, ingestion, etc In case of pathogenic effect on the target organism, specify the infective dose (the dose needed to cause infection with the intended effect on a target species) and transmissibility (possibility of spread of the microorganism in the target population, but also from one target species to another target species) after application under the proposed condition of use. Root absorption, systemic, distortion of meristem development Inhibits germination of spores Metabolite released and acts on target organism Promotes Systemic Acquired Resistance (SAR) (Add supporting evidence as an appendix to the dossier) 5.7 Directions for use Describe here the recommended directions for use. Page 17

18 s Watering Spraying Pulverizing at very low volume Localized spraying 5.8 Contraindications If there are any possible contraindications, state them together with evidence. If there is not room on the form, summarise and add evidence in an attached appendix. If there are certain types of pest control products with which this product is not compatible, also state here with evidence. s Not for use with fungicides Not for use on vegetables Not for use before blossom Not for use on crops of more than three years old Not to use on cereal destined to the production of seeds Only for use in nurseries (Add evidence as an appendix to the dossier) Section 6 Product registration 6.1 Previous registration number In the case of a renewal of registration, extension of use modification of composition and transfer of registration property, provide the previous registration number given. 6.2 Registration in other countries If already registered elsewhere, give a list of all the countries where registration for the product already exists and where uses are identical to those in the present application. Put countries with equivalent agroecological conditions to Ghana first in the list. Tick the white box in the left margin of the application form ( Registration certificates ), and attach the original(s) or a certified copy (from a commissioner of oaths or an advocate or equivalent) of the certificate(s) to the application form as Annex 5, adding a cover sheet marked Title: Overseas registration certificates; Section 6 Annex 5. Place the certificates in the same order as listed on the application form. On each certificate or certified copy, you must show the name of the country where the document has been issued. Page 18

19 Page B Section 7 Product formulation Formulation features 7.1 Appearance Indicate the physical properties of the product as well as its colour and its odour. s Clear brown and odourless liquid White powder with a light odour of cooked onion 7.2 Storage stability Measure stability of product as the percentage loss of activity or decline in cfu count of the active ingredient over time. For example: the stability of the product after storage at 54 C for 14 days. If the formulation is heat sensitive you can indicate other durations and/or other temperatures. In this case, the new parameters have to be specified. (ex: 8 weeks at 40 C, 18 weeks at 30 C). Refer to the CIPAC method MT 46. In general, if the loss of active ingredient exceeds 5% at 54 C over 14 days, information on storage has to be mentioned on the label. Storage trials data under different environmental conditions 7.3 Shelf life State the shelf life of the product at room temperature in Ghana: 30 C. Give this in years if it is more than two years, and in months if it is less than two years. Or, if refrigeration is required, give the shelf life and the specified refrigerated temperature. s 20 months at 30 C 6 months at 0-4 C 7.4 Density If the formulation is a liquid, specify the density according to the EU method A3 or to the CIPAC method MT3. For solid formulations enter Not applicable Bulk density If the formulation is a solid, state its density after compression according to CIPAC MT 33, MT 159 or MT 169, as applicable. For liquid formulations enter Not applicable. Page 19

20 Flammability Specify if the product is flammable according to EU methods A10, A11 and A12. Not flammable 7.7 ph of 1% aqueous solution Specify the ph of water-soluble formulations, otherwise mark Not applicable Wettability If the formulation is a solid used in dilution (wettable powders, powders soluble in water, granules soluble in water and water dispersible granules), state its wettability. Mark not applicable for the other types of formulation. 7.9 Water content Give the maximum water content (% of water content) recommended for the microbes. The water content is known to influence the shelf life of the microbes, the higher the water content the shorter the shelf life eg viability. 5% 7.10 Foam persistence If the formulation is a liquid intended for dilution in water, and if the dilution creates a foam, give the persistence in ml of foam per litre of diluted product after a stated number of minutes. Otherwise put Not applicable. s No foam persistence 10ml after 1 minute 7.11 Miscibility If the formulation is a liquid intended for ULV spraying, give the miscibility with oil carrier. Otherwise put Not applicable in the box. 5.5 Page Suspension ability Specify the ability of the formulated product to be suspended in a diluted

21 water based application (formulated products include wettable powders, soluble granules, concentrated suspensions, etc). Enter Not applicable for other formulations. Fully suspendable in water 7.13 Suspension rate If the formulation is of a water dispersible type (wettable powder, concentrated suspension etc), specify the suspension rate. Otherwise state Not applicable. Use a maximum of 20g per litre of water 7.14 Fineness If the formulation is dry flowable, state the results of the dry-sieve test. If it is a water dispersible type, give the results of the humid sieve test. 100% 7.15 Emulsion stability If the formulation is EC emulsion concentrate, state the stability of the diluted product. In other words, is there a risk of the product settling and separating out into the component parts? Otherwise state Not applicable Viscosity If the formulation is to be used at very low volume, state the viscosity. Otherwise state Not applicable. Pa s (N s m-2) Section 8 Toxicology This section on toxicology should identify the toxicological nature of the biopesticide. This data should be obtained from the tier reports which should be included in Annex 11. The basis of the toxicology information should be contained in a toxicology tier report from an EPA approved organization. Safety data sheet It is mandatory to provide a copy of the Safety data sheet (sometimes referred to as Material safety data sheet, or Safety Information ) on the formulated product. Please tick the white space of the right margin of the form to indicate the attachment of this item and mark the cover page Title: Safety data sheet; Section 8 annex 6 as defined on page 10 The sheet is composed of 15 sections, which are: 1 Identification of the substance and the company 2 Composition / information on components Page 21

22 3 Identification of hazards 4 First aid 5 Recommended methods and precautions for handling, storage, transportation and fire. 6 Emergency measures in case of accidental spillage or escape 7 Control of the exposure / individual protection 8 Chemical, physical and physiological properties 9 Stability and reactivity 10 Toxicological information 11 Ecological information 12 Information for destruction, decontamination and disposal. 13 Other information 14 Information on the possible occurrence of resistance and management strategies 15 Potential health effects and preventive measures 8.1 FAO/WHO class In this section place the FAO/WHO class according to the table below, based on the LD50 tests on rats. Place the Class in the left box and the Wording in the (un-labelled) right box. In the case that oral and dermal tests indicate different classes, select the higher class. The Pesticides Technical Committee accepts only the wordings and class categories given in this table: LD 50 (mg/ kg live weight - rat) Class Wordings Oral Dermal Solid Liquids Solid Liquids Ia Extremely toxic < 5 < 20 < 10 < 40 Ib Very toxic II Harmful III Caution > 500 > 2000 > 1000 > 4000 IV Unclassified II Harmful 8.2 Oral LD50 for rats Specify the value of the LD 50 after oral administration of the formulated product to rats mg/kg 8.3 Dermal LD50 for rats Specify the value of the LD 50 after dermal application of the formulated product to rats. Any skin reaction should be reported. If insufficient room on Page 22

23 form, add report as an annex mg/kg Skin became inflamed and quickly necrose 8.4 Inhalation LC50 for rats Specify the value of the LC after inhalation by rats. This data is applicable only to microbial formulations where the product is used with fogging equipment as an aerosol is to be used in a manner which generates a significant proportion of particles or droplets < 50 µm is to be applied by aircraft contains a volatile component at greater than 10%. State the duration of inhalation. If the product is not microbial, or is microbial but does not fall into one of the bullet point categories, put Not applicable mg/m3 (4h) 8.5 Skin irritation for rabbits The applicant indicates if there is irritation of rabbit skin after only one application of the non-diluted commercial product. If the product has a high ph, the test is not required because the substance is then considered as corrosive. In this case mark the form Not required because ph is high. Not irritant 8.6 Ocular irritation for rabbits State if there is irritation of rabbit eye after only one application of the nondiluted commercial product. A product with high ph or that has shown corrosive properties for the skin will not have to be tested. In this case mark the form Not required because ph is high. Light irritation 8.7 Skin sensitisation in guinea pigs The test will provide sufficient information to assess the potential to provoke skin sensitisation reactions. Add an annex if needed. 8.8 Other studies (if applicable) Before performing such studies, the applicant shall seek agreement of the regulatory authorities on the type of study to be performed. Add an annex if needed. Page 23

24 Section 9 Emergency measures / accident and fire This section covers all the emergence measures including those that require first aid, action after an accident and fire fighting measures. These should be detailed in full the Safety Data Sheet. 9.1 Potential health effects Symptoms of poisoning following exposure Mode of action in man, abnormalities and clinical symptoms with special attention to those whose susceptibility may be affected should be indicated. Therapeutic regimes for use in the event of ingestion or contamination of eyes and skin must be described in full. Information based on practical experience, where it exists and is available, in other cases on theoretical grounds as to the effectiveness of alternative treatment regimes, where relevant, must be provided. Information on resistance to antibiotics must be provided. 9.2 First aid measures Describe all of the following in the box provided. 1 First aid treatment / action(s) to be taken following accidental skin contact 2 First aid treatment / action(s) to be taken following accidental eye contact 3 First aid treatment / action(s) to be taken following accidental inhalation 4 First aid treatment / action(s) to be taken following accidental Ingestion 5 Note to physician 1 Skin contact: Remove soiled clothes and wash the body carefully 2 Eye contact: Flood the eye for at least 15 minutes with clean running water 3 Inhalation: Provide respiratory assistance where necessary and seek medical attention 4 Ingestion: Rinse the mouth with water, but don t induce vomiting 5 Note to physician: may cause temporary skin irritation 9.3 Antidotes List substances that can be used as antidotes. 9.4 Fire fighting measures Specify fire fighting measures and procedures in case of spillage Use only CO 2 or water for fire fighting 9.5 Other specific requirements Highlight any other requirements relating to emergence measures in your appendixes. These may include the following medical surveillance on manufacturing plant personnel and end users health records of occupationally exposed personnel in industry, agriculture, forestry, fisheries Page 24

25 Section 10 Labelling 10.1 Risk phrases Indicate which of the conventional risk phrases apply to the product. Choose the phrases from those listed in Appendix 1 page 48. R 22 - Harmful if swallowed 10.2 Safety phrases Indicate which of the conventional safety phrases apply to the product. Choose the phrases from those listed in Appendix 2 page 51. Not irritant 10.3 Pictograms Indicate which of the following pictograms will be used on the product: or or if no pictogram is need because the product presents no hazard, write None required. (To describe the pictogram on the application form you can draw it, or write Skull/crossbones or X-symbol.) 10.4 Label sample You must provide a sample of the label for the formulated product. Tick the box marked Label pattern to indicate that a sample of the label is included, and include a cover page as instructed on page 10, marked Title: Label sample; Section 10 Annex 7. Preparing the label sample The labelling must be in English and attached in a very conspicuous manner, readable horizontally when the packaging is in normal position. The label has to adhere by its entire surface to the packaging containing the substance. If the product is dispensed in several packages, the label or the inscription has to appear on each of them. Only labels prepared in the following manner will be accepted. Name of the product Safety phrase Warning First aid measures Medical instructions Hazard class / colour code Pictograms Active ingredient Summary of possible uses Registration number Batch N - Date Liability Name and address of the formulator Directions for use Cultural practices Pre-harvest interval Page 25

26 Background colour of the label Four colours are prescribed for the background of the label, depending on the function of the product. The labeling and advertising sub-committee will reject any colour that does not correspond exactly to the following specification. Function of the product Background colour Pantone number Insecticide - miticide Violet 237 Fungicide Yellow 109 Herbicide Green 375 Nematicides - Rodenticides - Avicides - Molluscicides - miscellaneous Blue 325 List of required packaging information elements All packaging or containers should provide the following indelible and legible information: 1 The commercial name or the designation of the product 2 The name and address of the product manufacturer and the local representative 3 The registration number of the product 4 The type of formulation (wettable powder, emulsifiable concentrate, etc) 5 The volume or net weight of the packaged product 6 The type of the product (insecticide, herbicide, etc) 7 The mode of action of the product (contact, systemic, etc) 8 The name and the concentration of each active ingredient 9 Uses (crop, harmful organism, dosage, stage of treatment) for which the product is authorized, and particular conditions in which the product can be used or must, on the contrary, be excluded (contraindications) in accordance with the registration decision. If relevant, the phrase For professional use only should be written legibly on the label. 10 Indications about possible toxicity for crops, the sensitivity of certain varieties of plants, direct or indirect adverse effect on crops and harvested products 11 Pre-harvest intervals 12 Possible incompatibilities with other products 13 Date of formulation (month and year) 14 Expiration date under normal storage conditions 15 Appropriate information on the storage conditions 16 The toxicological strip and hazard pictogram(s) In accordance with the hazard class established under the Classification of pesticides recommended by the WHO, the label has to include a toxicological coloured strip. Ensure that this toxicological strip covers more than 15% of the label surface. The table below shows the classification of hazard and their corresponding toxicological strip, colour and the symbol that should appear on the packaging or the container. Page 26

27 WHO hazard class Hazard indication Pantone reference Hazard symbol Ia Extremely harmful Extremely toxic Pantone red (magenta 100%, yellow 70%) Ib Very harmful Very toxic Pantone red 199 (magenta 100%, yellow 70%) II Moderately harmful Harmful Pantone yellow (yellow 100%, magenta 10%) III Slightly harmful Caution Pantone yellow (yellow 100%, magenta 10%) IV 17 Standard risk phrase that you have listed in section 10.2 above 18 Safety phrases that you have listed in 10.2 above 19 Safety precautions for the handling and using the product 20 Indications for safe disposal of the product and its package 21 Emergency measures in case of accidental exposure Section 11 Packaging Annex 8 - Packaging specifications A separate document specifying the product packaging is required. This must contain detailed information on the type of container, the capacity, the dimensions, the volume, and the weight. Attach the specification to the dossier, including a cover page in accordance with the instructions in page 10 marked Title: Packaging specifications Section 11 Annex 8 and tick the box on the application form to indicate that you have attached the annex. Packaging for pesticides must be designed in accordance with the criteria and guidelines specified in the FAO Guidelines for the packaging of pesticides. The following should be specified: 1 Type of packaging in which the product is imported If the products are grouped for distribution in multiple packs (for example if a liquid is packaged in a bottle and the bottles are supplied in tens enclosed in a corrugated outer box), the outer packaging should also be described under the same headings. 2 Type of packaging for distribution in Ghana 3 Packaging material fully described Packaging must be fully described and specified in terms of the materials used, manner of construction (eg extruded, welded, etc), size and capacity, size of opening, type of closure and seals. 5 Packaging specification The suitability of the packaging, including closures, in terms of its strength, Page 27

28 leak-proofness and resistance to normal transport and handling must be determined and reported according to ADR Methods 3552, 3553, 3560, 3554, 3555, 3556, 3558 or appropriate ADR Methods for intermediate bulk containers, and, where the preparation child-resistant closures are required, according to ISO standard Sizes of individual packaging Products distributed to the market must be kept in their original container or package. 6 Packaging safety handling information Indicate transport safety requirements to be used on outer packaging in accordance with the international symbols adopted for air, sea, rail and land transportation. Code IMO-IMDG : Class group III - label 6.1 (KEEP AWAY FROM FOOD) mark p marine Pollutant 11.1 Packaging Summarising briefly the information from the Packaging Specification, Annex 8, please give 1 the specification of the immediate product packaging. 2 the specification of any outer / bulk / shipping packs used to contain the immediate product packs. 1 Product package: 65g HDPE bottle with tamperproof cap in PET 2 Outer package: Corrugated B-flute double walled cardboard case containing 10 times 1 litre bottles 11.2 Capacity Give the capacity of the commercial package. 1 litre 11.3 Disposal of packaging Give advice on the disposal of empty packages in conformity with the information given on the safety data sheet. Triple wash empty bottles, make holes to render unusable and burn Page 28

29 Page C Trials Page C of the application form deals with product trials. You must include one copy of this page for every trial that has been conducted. The purpose of the trials is to determine the efficiency of the product for its stated purpose the selectivity with which it acts on the target crop the presence of any residues upon harvested crops Indicate the year in which the trial was completed, and tick one only of the three boxes (efficiency/selectivity/residues) according to the type of trial. The number of trials conducted is at the discretion of EPA, however three are strongly recommended. Section 12 Site 12.1 Organisation Organisation means the Research and Development organisation. Department of Crop Science, University of Accra 12.2 Site The site where the trial was conducted Field trial site, Akanbo 12.3 Address Give the address (geographically identifiable) of the place where the test has been conducted Soil class Give the soil class of the trial site. Refer to the FAO list of soil classes for tropical regions and select one of the following: Fluvisol, gleysol, regosol, lithosol, arenosol, rendzina, ranker, andosol, vertisol, solonchak, solonet, yermosol, xerosol, kastanozem, chernozem, phaeozem, greyzem, cambisol, luvisol, podzoluvisol, podzol, planosol, acrisol, nitosol, ferralsol, histosol. Vertisols 12.4 Climate type Indicate precisely the climate of the area where the trial site is located. Tropical humid Section 13 Object 13.1 Tested product / manufacturer / active ingredient(s) Specify the commercial name of the formulation that is tested, and give the Page 29

30 manufacturer, the active ingredient(s) and their guaranteed grades in %, g/l, cfu or other relevant unit Reference product Give the commercial name and the manufacturer of the reference product that was used in the test. If no reference product was used, put None. When possible, the reference has to be a marketed product of recognized efficiency, and having a mode of action analogous or identical to that of the product used in the trial Plant material and variety Identify the crop or the vegetable product on which the trial was conducted. Name the crop by its common and scientific taxonomic name. Give the variety. Maize Zea mays, variety Roma 13.4 Agricultural practices Describe the main agricultural practices that have been conducted in the test. s Crop irrigation Manual weeding 13.5 Target organism Identify the target organism by its common name and by its Latin name. Rice leaf beetle Oulema oriza 13.6 Strain / race Specify the strain or the race of the target organism studied in the test. Otherwise put Not applicable. Section 14 Layout Annex 9 - Protocol Attach the protocol report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include Title: Protocol; Section 14 Annex 9 You must include this Annex for every iteration of page C that you submit in your dossier. These protocols of test have to be complete Layout Describe the layout of the trial. Randomised block test with 6 replicates 4 corn cribs Page 30

31 14.2 Treated plot Describe the treated plot area (size) and the treatment design chosen for the trials. Plot of 2m width and 10m length (20 m 2 ) Crib of 1m width and 2m height, with a griddle roof 14.3 Control plot Describe the control plot area (size) its place in the treatment design. Untreated plots randomly distributed in 6 blocks Section 15 Treatments 15.1 Stage or timing of treatments Indicate the stages or the treatment periods used in the trial. Several periods or successive stages can be listed. During blossom Harvest 15.2 Frequency Give the frequency of the applications made during the trial. If only one treatment was made put Not applicable Dosage The used dosage is indicated on the basis of treated units (ha, m 2, m 3, t...), in grams or in litres of preparation. Make sure that the unit is specified after the value. Include also the corresponding concentration of microorganism per treated area in appropriate units, eg cfu. 1 l/ha; 1000cfu 100 g/kg bait; 1000cfu 15.4 Directions for use Describe the methods of application used in the trial. Spraying Spraying at very low volumes 15.5 Particular conditions This section describes particular conditions noticed during the test that could influence its results. Page 31