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

32 Rainfall for 5 days (100mm) Section 16 Observations and results Annex 10 - Trial report Attach the trial report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording Title: Protocol; Section 16 Annex 10 You must include this Annex for every iteration of page C that you submit in your dossier Variable You can show up to three aspects of the trial s Number of larvae Intensity of weed infestation Intensity of phytotoxicity Intensity of attack Yield 16.2 Stage or timing The timing at which the observations were made. The day of the spraying Blossoming 16.3 Conclusion Include the result of the analysis of the observations. Increase of 15% in yield compared to the control plot; Good protection of fruit Disease incidence reduced by 40% Section 17 Assessment Place your assessment of the trial in the box provided. Test not valid because of low disease incidence Valid test - proves an efficiency superior (by 7%) of the tested product used at the dosage of 20 g/l compared to the reference product at its registration dosage. - the tested product has to be used only on young rootplants. Page 32

33 Page D Active ingredient Complete this page separately for every Active Ingredient in the formulated product (and remember that two copies of the whole dossier are required, so for example if you have four AIs you will be submitting Page D eight times). Section 18 Designation A sample of the microorganism should be deposited at the Bio-Control Unit of the Plant Protection and Regulatory Services Directorate of the Ministry of Food and Agriculture located at Pokuase Taxonomic identity Each micro-organism that is included in to the application should be identified and named at the species level. The scientific name and taxonomic grouping, ie family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro-organism, must be stated. Additionally indicate whether the micro-organism: 1 is indigenous or non-indigenous at the species level to the intended area of application 2 is a wild type 3 is a spontaneous or induced mutant 4 has been genetically modified Bacillus thuringiensis var. kurstaki. / induced mutant Section 19 Physiological, physical and chemical properties 19.1 Appearance Specify the physical appearance of the active ingredient as well as its colour and odour. Grey/brown spores, odourless 19.2 Uses, natural occurrence and geographical distribution Give the geographical region and the place in the ecosystem (eg host plant, host animal, or soil from which the micro-organism was isolated). Report the method of isolation of the micro-organism. If possible give the natural occurrence of the micro-organism in the relevant environment at strain level. Indicate whether the micro-organism has been GRAS (generally regarded as safe) listed. Grey/brown spores, odourless 19.3 Description of the target organism Describe principal mode of action. If the micro-organism produces a toxin with a residual effect on the target organism, also describe the mode of action of this toxin. If relevant, give information on the site of infection and mode of entry into Page 33

34 the target organism and its susceptible stages. Report the results of any experimental studies. State whether or not the micro-organism or its metabolites are translocated in plants and, where relevant, how this translocation takes place. In cases of pathogenic effect on the target organism, state - after application under the proposed condition of use - the infective dose (the dose needed to cause infection with the intended effect on a target species) and transmissibility (possibility of spread of the micro-organism in the target population, but also from one target species to another target species). Grey/brown spores, odourless 19.4 Host specificity range and effects on other species 1 Give any available information on the effects of the micro-organism on nontarget organisms within the area to which the micro-organism may spread. 2 Indicate the occurrence of non-target organisms that are either closely related to the target species or that are especially exposed. 1 Range: organism is highly specific to target 2 Related non-target organisms: African Bollworm 19.5 Development stages/life cycle Provide information on each numbered point: 1 ife cycle of the micro-organism described (including symbiosis, parasitism, competitors, etc) on the target host organisms, as well as vectors for viruses. 2 the generation time 3 the type of reproduction of the micro-organism Give information on the occurrence of 4 resting stages 5 their survival time, 6 their virulence 7 infection potential 1 Life cycle: infects when ingested by larvae. Infects host immediately causing death after 3-4 days. 2 Generation time: 10 hours 3 Type of reproduction: organism is a virus and reproduces through infection of other organisms 4 Resting state: not applicable 5 Survival time: until death of infected host 6 Virulence: highly virulent 7 Infection potential: highly infective in target organism, otherwise, None Page 34

35 19.6 Infectivity, dispersal and colonization ability Provide information on the behaviour of the micro-organism under typical environmental conditions of use and compared to the environmental conditions, if any, under which the micro-organism may infect, colonize or damage mammalian tissues Also provide information on possible dispersal routes of the micro-organism (via air as dust particles or aerosols, with host organisms as vectors, etc), under typical environmental conditions relevant to the use. Infectivity: after spores are produced and discharged, they must survive until contacting a new host. Frequent causes of spore mortality include high temperatures, desiccation, and solar radiation. In the soil environment, decreased spore survival can also be caused by other saprophytic microorganisms. Dispersal and colonisation: airborne, asexual spores (conidia) of most biopesticides have frequently been considered very short-lived. Fungal pathogens spread in a variety of ways over varying distances depending on their adaptation. Movement of soil-inhabiting fungal entomopathogens is very limited although spores can be washed through soil or fungal mycelia originating in cadavers can locally spread through soil. Spores of soil-inhabiting fungi that infect insects living above-ground can leave the soil environment by attaching, saprophytically to plant matter. Although other animals can vector entomopathogens, potential spread by these means is negligible. For many fungal entomopathogens, production of aerially dispersing spores is associated with relative humidity. Infectivity: occurs through contact or by ingestion. Dispersal: occurs by contact and attached to moving bodies (insects, animals, human clothing) and also moved in the wind and air currents. Colonization: grows and colonizes only insects. No known mammalian colonization reported Effect of environmental factors Indicate the persistence of the micro-organism and its toxins under the typical environmental conditions of use. Any particular sensitivity to certain components of the environment (eg UV light, soil, water) must be stated. State the environmental requirements for survival, reproduction, and effectiveness of the micro-organism. Resting spore known to exist in soil for over two years, though likely to be longer. All spore stages destroyed by UV light, therefore persistence in crop canopy based on UV exposure. Colonization rapid under RH conditions above 75%. Metabolites effects recorded as minimal after 120 hours. Page 35

36 19.8 Relationships to known plant, animal or human pathogens State any possible existence of one or more species of the genus of the active agent and/or, where relevant, contaminating micro-organisms known to be pathogenic to humans, animals, crops or other non-target species and the type of disease caused by them. 2 State whether it is possible, and if so by which means, to clearly distinguish the active micro-organism from the pathogenic species. Organisms in this genus have no known pathogenic effect to any mammals, or plants. Genus widely reported to be pathogenic to the non-target Coleoptera. Identification required by using by DNA sequencing 19.9 Genetic stability and factors affecting it Where appropriate, provide information on genetic stability (eg mutation rate of traits related to the mode of action or uptake of exogenous genetic material) under the environmental conditions of proposed use. Where appropriate, information must also be provided on the microorganism s capacity to transfer genetic material to other organisms as well as its capacity to being pathogenic for plants, animals or man Production of metabolites If other strains belonging to the same microbial species as the strain subject to the application are known to produce metabolites with effects on human health and/or the environment during or after application, provide information on the following: 1 the nature and structure of this substance 2 its presence inside or outside the cell and its stability, its mode of action (including external and internal factors of the micro-organism necessary to action) 3 its effect on humans, animals or other non-target species. 4 the conditions under which the micro-organism produces the metabolites (especially toxins) 5 the mechanism by which the micro-organisms regulate the production of these metabolites 6 the influence of the produced metabolites on the micro-organism s mode of action Antibiotic and other anti-microbial properties Some micro-organisms produce antibiotic substances which may interfere with the use of antibiotics in human and veterinary medicine. This must be avoided at any stage of the development of a microbial plant protection product. Information on the micro-organism s resistance or sensitivity to antibiotics or other anti-microbial agents must be provided, in particular the stability of the genes coding for antibiotic resistance, unless it can be justified that the microorganism has no harmful effects on human or animal health, or that it cannot transfer its resistance to antibiotics or other anti-microbial agents. Page 36

37 19.12 Reactivity towards container material Provide information with evidence of how the formulated product reacts with the material used for the container. Container manufacturer s specifications and reactivity report attached. No reactivity reported to oil based substances over 2 year test period recorded. Section 20 Purity 20.1 Minimal purity Give the purity of pure active ingredient as a percentage of the total formulated product. 78% Section 21 Toxicology The purpose of this section is the toxicological classification of the active ingredient, the selection of the correct safety (S) and risk (R) phrases, and the calculation of the ADI for human beings. These data also serve as the basis for the definition of appropriate emergency measures. Annex 11 - Toxicology summary Attach a report describing and evaluating the toxicology of the active ingredient, expanding upon the information provided in this section. Attach the report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording: Title: Toxicology summary; Section 21 Annex 11 General requirements If other strains belonging to the same microbial species as the strain subject to the application are known to produce metabolites (especially toxins) with unacceptable effects on human health and/or the environment during or after application, the nature and structure of this substance, its presence inside or outside the cell and its stability, its mode of action (including external and internal factors of the micro-organism necessary to action) as well as its effect on humans, animals or other non-target species shall be provided. The conditions under which the micro-organism produces the metabolite(s) (especially toxins) must be described. Any available information on the mechanism by which the micro-organisms regulate the production of the(se) metabolite(s) should be provided. Any available information on the influence of the produced metabolites on the micro-organism s mode of action should be provided. Which tier report(s) are required? Toxicological data may be waived where there is sufficient evidence that the product is safe. This would be based on results of medical surveillance, published data, as well as actual studies on the product. Page 37

38 Where no evidence is provided, or where there is insufficient evidence, toxicological studies have to be conducted as indicated under Tier 1 in the first instance. Tier 2 is applied when, in the absence of evidence of pathogenicity, either toxicity or infectivity is observed in Tier 1. Tier 3 is applied when there are issues of known or suspected subchronic toxicity and human pathogenicity and tests for effects following long-term exposure and particular adverse effects of intracellular parasites of mammalian cells. Tier 1,2 and 3 studies are evaluating the toxicology of the active ingredient to be registered. However where the active ingredient and the formulated are the same, then the studies may use the formulated product. Tier 1 studies Active agent and/or technical grade Medical surveillance data for manufacturing plant and agricultural workers (such as occurrence of hypersensitivity/allergies) Submit reports of occupational health surveillance programmes. These reports shall, where available, include data from persons exposed in manufacturing plants or after application of the micro-organism (eg in efficacy trials). Special attention should be devoted to those whose susceptibility may be affected, eg pre-existing disease, medication, compromised immunity, pregnancy or breast feeding. Provide all available information on the sensitisation and allergenic response of workers, including workers in manufacturing plants, agricultural and research workers and others exposed to the micro-organism, and include, where relevant, details of any incidences of hypersensitivity and chronic sensitisation. Submit all available reports from the open literature on the micro-organism or closely related members of the taxonomic group (relating to clinical cases), where they are from reference journals or official reports. Acute oral LD50 mg/kg LC50 (rat/rabbit) This should be provided for all contents of the formulated product, including for instance solvents and carriers as listed in the contents. Inhalation LC50 mg/l/4 hour (rat/rabbit) Give potential risks due to infectivity and pathogenicity. Genotoxicity If the micro-organism produces exotoxins, then these toxins and any other relevant metabolites in the culture medium must also be tested for genotoxicity. Such tests on toxins and metabolites should be performed using the purified chemical if possible. Page 38 If toxic metabolites are not formed, studies on the micro-organism itself should be considered depending on expert judgement on their relevance. Genotoxicity of cellular micro-organisms should be studied after breaking of the cells where ever possible. In the case of a virus the risk of insertional mutagenesis in mammal cells or the risk of carcinogenicity has to be addressed.

39 Intra-peritoneal (fungi and protozoa)/ intravenous (others) injection for infectivity The intraperitoneal/subcutaneous test is considered a highly sensitive assay to elicit response in particular infectivity studies. The intraperitoneal injection is required for all micro-organisms. However, expert judgement may be exercised to evaluate whether subcutaneous injection is preferred instead of intraperitoneal injection if the maximum temperature for growth and multiplication is lower than 37ºC. Discussion of the effects of repeated human exposure Provide any available information on the subject Other studies Provide any available information on other studies Tier 2 studies Active agent and/or technical grade Subchronic toxicity 28 day NOEL mg/kg/day Examine for toxicological and pathological changes in appropriate organs. Tier 3 studies Active agent and/or technical grade Chronic toxicity/carcinogenicity noel mg/kg/day (mouse/rat) The assessment of risk from lifetime exposure to micro-organisms/toxins of concern may require examination for long-term toxicological and pathological changes in appropriate organs. Neurotoxicity NOEL mg/kg/day The assessment of risk from lifetime exposure to micro-organisms/toxins of concern may require examination for toxicological and pathological changes in nervous system. Teratogenicity NOEL mg/kg/day The assessment of risk from lifetime exposure to micro-organisms/toxins of concern may require examination of toxicological and pathological changes in appropriate organs. Reproduction (rat/rabbit) The assessment of risk from lifetime exposure to micro-organisms/toxins of concern may require examination of toxicological and pathological changes in the reproductive system. Annex 12 Other studies Optionally, you can use this section to indicate results of other studies Page 39

40 relevant to the toxicology of the product. Tick the white space in the right margin of the form to indicate inclusion of this attachment and provide a cover page in accordance with the instructions in page 10. The cover page should include the wording Title: Other toxicological studies; Section 21 Annex 12 Completing the toxicology (section 21) part of the application form The following data should be taken from the Toxicology summary and inserted onto section 21 of page D of the application form NEL Provides the value of the highest non effect dosage estimated on the most sensitive tested animals (NEL in mg of product / kg of live weight of the animal). Rat 7.4mg/kg/day 21.2 ADI Indicates the admissible daily intake of the active ingredient by human beings, in mg / kg of live weight of human beings and per day mg/kg/day 21.3 Toxicity to rats In the boxes provided, indicate the LD 50 value for rats by ingestion in mg/kg, the dermal LD50 in mg/kg and the inhalation LC50 in mg/l Dermal: LD 50 = 8.9 mg/kg for rat Inhalation: LC 50 = 4.1 mg/l of air for rat Page Rabbit sensitivity Give the rabbit skin and eye irritation results 21.5 Guinea pig sensitisation Guinea pig sensitisation is not mandatory, and EPA will confirm the requirements and parameters when and if this test is need Further information about toxicity to rats provide the following in relation to rats: Subchronic toxicity Chronic toxicity Carcinogenicity Neurotoxicity Teratogenicity 21.7 Genotocixity Rat: give the results of studies (in vivo) of lethal dominance on rats (hereditary

41 character of the mutation). Complementary results of genotoxicity studies (studies on somatic cells, on germinal cells, etc) must be given in the summary report - annex 11. Unicellular organisms: give results of the test of Ames (in vitro) on unicellular organisms (Salmonella typhimurium, Escherichia coli) Rat metabolism Determine the process of absorption, distribution, accumulation, biotransformation, elimination, etc, of the active ingredient for rats. Very rapid elimination in urine (70% in 48h) and faeces (80% in 48h) Section 22 Plant residues This section aims to establish a MRL (Maximum Residue Level). Annex 13 - Residue summary Attach a report describing the behaviour of residues, expanding upon the information provided in this section of the application form. Attach the report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording: Title: Plant residues; Section 22 Annex 13 The application shall state to which extent and on which basis it is considered that the micro-organism can (or cannot) multiply in or on the plant or plant product or during processing of raw products. For the evaluation of risk arising from residues, experimental data on levels of exposure to the residue may not be required where it can be justified, that the micro-organism and its metabolites are not hazardous to humans in the concentrations that could occur as a result of authorised use. This justification can be based on published literature, on practical experience. The information provided, taken together with that for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risk for man and/or animals, arising from exposure to the micro-organism and its residual traces and metabolites (toxins) remaining in or on plants or plant products. Content of the residue study Identity of residues Specify Level and behaviour of residues Describe the process of metabolisation of the active ingredient in the plant and the subsequent breakdown products. Indicate the action and the persistence of the metabolites/agent/viable and non-viable residues in the plants and animals. Page 41

42 Major metabolites/agents (viable and non-viable) Provide either an executive summary or individual summaries of studies conducted concerning the issues listed. Specify the metabolites/viable and non-viable residues. State their toxicological effects and retention of microbial activity. PHI and withholding periods in case of post-harvest use For each crop, state the Pre-Harvest Interval (PHI), and withholding period. State MRLs where applicable. Method of residue analysis Provide a copy of the protocol used with references. Residue data have to be provided for bioproducts if they are found to have toxicological, infective and pathogenic effects on mammals. Residue data from an EPA certified laboratory or as directed by the EPA secretary Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form Effects on taint, odour, taste or other quality aspects due to residues in or on fresh or processed products Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form Effects of industrial processing and/or household preparation on the nature and magnitude of residues Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form Residue data in succeeding rotational crops where presence of residues might be expected (where appropriate) Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form Assessment of the likely residue levels encountered by persons handling treated produce Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form * For pest control products found to have allergenic effects, detailed studies (on their residues) have to be provided. Completing section 22 of the application form 22.1 Metabolism Describe the principle of metabolisation of the active ingredient in the plant and the metabolites that are formed. Hydrolysis of the ester function - cyclopropane forming Page 42

43 22.2 Behaviour of residues Indicate the action and the persistence of the metabolites in the plant. Residues < 1,2 mg/kg after 14 days 22.3 MRL For each crop or vegetable product, show the MRL recommended by the Commission of the Codex Alimentarius, two effective MRL in two different countries and the MRL proposed for Ghana. The proposed MRL has to be the lowest value among the calculated MRL and the observed MRL. The observed MRL result from the estimation of maximum levels of residues subsisting in crop treated in good agricultural practices. Refer to FAO guidelines relative to the Tests of pesticide residues to obtain applicable data for purposes of pesticide registration and establishment of maximal residue limits. Section 23 Ecotoxicity Annex 14 - Ecotoxicological summary Attach a report describing and evaluating the effect of the active ingredient on the environment, expanding upon the information provided in this section. Attach the report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording Title: Summary of environmental studies; Section 24 Annex 14 Content of the ecotoxicity study Effects on birds If relevant to the proposed use scenario, provide details of toxicity, infectivity and pathogenicity to at least one land and one water bird, LD50 in mg product and cfu or equivalent/kg bird weight. Provide NOEL for one species studied and information on the effect on reproduction. Effects on aquatic organisms If relevant to the proposed use scenario, provide details of effects on aquatic organisms: 1 Fish (2 species) 2 Daphnia (1 species) 3 other fresh water invertebrates Provide details of toxicity, infectivity and pathogenicity to at least two species studied, LC50 (in mg of product and cfu or equivalent/litre of water) Algae State the effects on algal growth, growth rate and capacity to recover. Plants other than algae Information on effects on plants other than algae must be reported. Page 43

44 Effects on bees Information on toxicity, infectiveness and pathogenicity to bees must be reported. Effects on arthropods other than bees Information on toxicity, infectiveness and pathogenicity to arthropods other than bees must be reported. The selection of the test species should be related to the potential use of the plant protection products (eg foliar or soil application). Special attention should be given to organisms used for biological control, other pollinators, and organisms playing an important role in integrated pest management. Effects on soil dwelling invertebrates Information on toxicity, infectiveness and pathogenicity to earthworms and/or termites and dung beetles, according to the ecosystem, must be reported. Effects on non-target soil microorganisms Impact on relevant non-target micro-organisms and on their predators (eg protozoa for bacteria inoculants) should be reported. The applicant indicates if the active ingredient shows an action on the activity of soil microorganisms (bacteria, fungi) and an effect on the respiration of the soil or the mineralisation of nitrogen and carbon. This section is "without object" for products with which there is no risk of soil contamination. Inhibition effects on bacteria at concentrations of 100 ppm after 100 days Effects on non-target plants If the agent is closely related to a crop pathogen or a pathogen of a vertebrate species, laboratory evidence of genetic stability using appropriate tests is required. Additional studies The additional studies might include further acute studies on additional species or processes (such as sewage systems) or higher tier studies such as chronic, lethal or reproduction studies on selected non-target organisms. Before performing such studies, the applicant shall seek agreement of the regulatory authorities on the type of study to be performed. Completing section 23 of the application form 23.1 Toxicity for birds Specify the species that have been studied and give reasons for their selection. Page 44 1 the value of the LD 50 (in mg of product / kg live weight of the bird) by application of a single oral dose and monitored for 14 days. 2 The non observable effect level (NOEL, in mg of product / kg live weight of the bird) on the animal and on its reproduction. 3 The LC 50 (in mg of product / kg of food) after 5 days feeding. 4 Information about reproduction

45 23.2 Toxicity for fishes Specify the species that has been studied and give: 1 the value of the LC 50 (in mg of product / l of water) 2 the non observable effect level (NOEL) in mg of product / l of water on the fish and on its reproduction 3 a value of the bioconcentration factor (BCF) of the active ingredient in tissues 4 Information about reproduction LC 50: 50mg per litre NOEL: 0.5mg per litre BCF: 500mg/kg of fresh tissue Reproduction unimpaired 23.3 Toxicity for daphnia The applicant gives the value of the LC 50 (in mg of product / l of water) and the NOEL (in mg of product / l of water) for Daphnia. LC 50: 50mg per litre NOEL: 0.5mg per litre 23.4 Toxicity for algae The applicant gives a value of the concentration inhibiting the multiplication and growth of 50% of algae (IC h, in mg of product / l of water) and a value of the NOEL (in mg of product / l of water). LC 50: 50mg per litre NOEL: 0.5mg per litre 23.5 Toxicity for bees Give a value of the LD or LC 50 by ingestion (LD 50 in g. - 48h) and a value of LD 50 by contact (LD 50 con. - 48h) for bees (in mg of product / bee). If there is no risk of contact with the product (rodenticide bait, treatment of seeds, etc) mark Not applicable. LC cfu/l of diet 23.6 Toxicity for earthworms Give the value of the LC 50 (in mg of product / kg dry soil) for earthworms. Mark Not applicable for products with which there is no risk of soil contamination. 10 mg of product / kg dry soil Page 45

46 23.7 Toxicity for soil microorganisms The applicant indicates if the active ingredient shows an action on the activity of soil microorganisms (bacteria, fungi) and an effect on the respiration of the soil or the mineralisation of nitrogen and carbon. This rubric is without object for products with which there is no risk of soil contamination. Inhibition effects on bacteria at concentrations of 100 ppm after 100 days Annex 15 - Other studies Optionally, attach a report describing other data relevant to the ecotoxicity. Tick the white box marked Other data to indicate that you have attached this report. Attach the report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording Title: Summary of environmental studies; Section 24 Annex 14 Section 24 Action on the environment Annex 15 - Summary of environmental studies Attach a report describing and evaluating the effect of the active ingredient on the environment, expanding upon the information provided in this section. Attach the report to the dossier, including a cover page in accordance with the instructions in page 10. The cover page should include the wording Title: Summary of environmental studies; Section 24 Annex Behaviour and ways of breakdown in the soil Indicate the breakdown pathways of the active ingredient in the soil and the breakdown products that are formed. Indicate also persistence (days) and retention of biological activity. Specify major metabolites/viable or non-viable residues in soil where appropriate, and their behaviour in the soil. The product tested was a living organism and is naturally broken down into minerals, carbon, oxygen and carbon dioxide. Where organic matter is present then the product will persist as a saprophyte growing on this media. If no organic matter then the product will die and breakdown rapidly. If present on the soil or plant plant surface the product will be destroyed by UV light 24.2 Mobility in the soil 1 Describe the vertical and horizontal movement of the active ingredient and its degradation or breakdown products in the soil. 2 Specify the degree of mobility of the active ingredient in the soil, hence leaching potential and possibility for groundwater contamination. 3 Specify the major metabolites, viable or non-viable residues in the soil and their behaviour Page 46

47 Persistence is dependent on environmental conditions Frequent causes of spore mortality include high temperatures, desiccation, and solar radiation. In the soil environment, decreased spore survival can also be caused by other saprophytic microorganisms. Although other animals can vector entomopathogens, potential spread by these means is negligible Absorption State the degree of absorption of the active ingredient and metabolites in the soil. Degree of absorbtion: high 24.5 Behaviour and pathways of degradation in surface and ground water Describe, for surface and ground water: 1 the pathways of degradation or breakdown 2 rate of degradation or breakdown 3 the major degradation or breakdown products formed 4 their absorption/desorption on sediments (all points must be answered) Organic substance breakdown components carbon dioxide and water For many fungal entomopathogens, production of aerially dispersing spores is associated with relative humidity. Annex 16 - Other studies You can (optionally) attach a further report to show results of other relevant studies of product behaviour in environment. Tick the white space in the right margin of the form to indicate that you have attached this annex and include a cover page in accordance with the instructions in page 10. The cover page should include the wording Title: Environmental report; Section 24 Annex 16. Page 47

48 Appendix 1 Risk phrases A statement of particular risks to human beings, animals and the environment should be made on the label using sentences chosen in an appropriate manner from the following list. R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 R11 R12 R13 R14 R15 R16 R17 R18 R19 R20 R21 R22 R23 R24 R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 Explosive when dry Risk of explosion by shock, friction, fire or other sources of ignition Extreme risk of explosion by shock, friction, fire or other sources of ignition Forms very sensitive explosive metallic compounds Heating may cause an explosion Explosive with or without contact with air May cause fire Contact with combustible material may cause fire Explosive when mixed with combustible material Flammable Highly flammable Extremely flammable Liquid gas extremely flammable Reacts violently with water Contact with water liberates extremely flammable gas Explosive when mixed with oxidizing substances Spontaneously flammable in air In use, may form flammable/explosive vapour-air mixture May form explosive peroxides Harmful by inhalation Harmful in contact with skin Harmful if swallowed Toxic by inhalation Toxic in contact with skin Toxic if swallowed Very toxic by inhalation Very toxic in contact with skin Very toxic if swallowed Contact with water liberates toxic gas Can become highly flammable in use Contact with acids liberates toxic gas Contact with water liberates very toxic gas Danger of cumulative effects Causes burns Causes severe burns Irritating to eyes Irritating to respiratory system Irritating to skin Danger of very serious irreversible effects Possible risks of irreversible effects Risks of serious damage to eyes Page 48

49 R42 R43 R44 R45 R46 R47 R48 R49 R50 R51 R52 R53 R54 R55 R56 R57 R58 R59 R60 R61 R62 R63 R64 May cause sensitization by inhalation May cause sensitization by skin contact Risk of explosion if heated under confinement May cause cancer May cause heritable genetic damage May cause congenital malformations Danger of serious damage to health by prolonged exposure may cause cancer by inhalation Very toxic to aquatic organisms Toxic to aquatic organisms Harmful to aquatic organisms May cause long term adverse effect in the aquatic environment Toxic to flora Toxic to fauna Toxic to soils organisms Toxic to bees May cause long term adverse effect in the environment Dangerous for the ozone layer May impair the fertility May cause harm to the unborn child Possible risks of impaired fertility Possible risks of harm to the unborn child May cause harm to breastfed babies R39/23/24 Toxic: danger of very serious irreversible effects through inhalation and in contact with skin R39/23/25 Toxic: danger of very serious irreversible effects through inhalation and if swallowed R39/24/25 Toxic: danger of very serious irreversible effects in contact with skin and if swallowed R39/23/24/25 Toxic: danger of very serious irreversible effects by inhalation, in contact with skin and if swallowed R39/26 Very toxic: danger of very serious irreversible effects through inhalation R39/27 Very toxic: danger of very serious irreversible effects in contact with skin R39/28 Very toxic: danger of very serious irreversible effects if swallowed R39/26/27 Very toxic: danger of very serious irreversible effects by inhalation and in contact with skin R39/26/28 Very toxic: danger of very serious irreversible effects by inhalation and if swallowed R39/27/28 Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed R39/26/27/28 Very toxic: danger of very serious irreversible effects through inhalation R40/20 Harmful: possible risks of irreversible effects through inhalation, in contact with skin and if swallowed R40/21 Harmful: possible risks of irreversible effects in contact with skin R40/22 Harmful: possible risks of irreversible effects if swallowed R40/20/21 Harmful: possible risks of irreversible effects through inhalation and in contact with skin R40/20/22 Harmful: possible risks of irreversible effects through inhalation and if swallowed Page 49

50 R40/21/22 Harmful: possible risks of irreversible effects in contact with skin and if swallowed R40/20/21/22 Harmful: possible risks of irreversible effects through inhalation, in contact with skin and if swallowed R42/43 May cause sensitization by inhalation and by skin contact R48/20 Harmful: danger of serious damage to health by prolonged exposure through inhalation R48/21 Harmful: danger of serious damage to health by prolonged exposure R48/22 Harmful: danger of serious damage to health by prolonged exposure if swallowed R48/20/21 Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin R48/20/22 Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed R48/21/22 Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed R48/20/21/22 Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed R48/23 Toxic: danger of serious damage to health by prolonged exposure through inhalation R48/24 Toxic: danger of serious damage to health by prolonged exposure in contact with skin R48/25 Toxic: danger of serious damage to health if swallowed R48/23/24 Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin R48/23/25 Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed R48/24/25 Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed R48/23/24/25 Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed R50/53 Very toxic to aquatic organisms, may cause long term adverse effect in the aquatic environment R51/53 Toxic to aquatic organisms, may cause long term adverse effect in the aquatic environment R52/53 Harmful to aquatic organisms, may cause long term adverse effect in the aquatic environment Page 50

51 Appendix 2 Safety phrases Precautions to take for the protection of human beings, animals and the environment are shown on the label using specific sentences. S37 Wear suitable gloves S38 In case of insufficient ventilation, wear suitable respiratory equipment S39 Wear eye/face protection S40 To clean the floor and all objects contaminated by this material, use... (to be specified by the manufacturer) S41 In case of fire and/or explosion do not breathe fumes S42 During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer) S43 In case of fire, use... (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add: Never use water ) S45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible) S46 If swallowed, seek medical advice immediately and show this container or label S47 Keep at temperature not exceeding... C (to be specified by the manufacturer) S48 Keep wet with... (appropriate material to be specified by the manufacturer) S49 Keep only in the original container S50 Do not mix with... (to be specified by the manufacturer) S51 Use only in well-ventilated areas S52 Not recommended for interior use on large surface areas S53 Avoid exposure - obtain special instructions before use S56 Dispose of this material and container hazardous or special waste collection point S57 Use appropriate container to avoid environmental contamination S59 Refer to manufacturer/supplier for information on recovery/recycling S60 This material and its container must be disposed of as hazardous waste S61 Avoid release to the environment. Refer to special instructions/safety Data Sheets S62 If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label S1/2 Keep locked up and out of the reach of children S3/7 Keep container tightly closed in a cool place S3/9/14 Keep in a cool, well-ventilated place away from... (incompatible materials to be indicated by the manufacturer) S3/9/14/19 Keep only in the original container in a cool, well-ventilated place away from... (incompatible materials to be indicated by the manufacturer) S3/9/49 Keep only in the original container in a cool, well-ventilated place S3/14 Keep in a cool away from... (incompatible materials to be indicated by the manufacturer) S7/8 Keep container tightly closed and dry S7/9 Keep container tightly closed in a well-ventilated place S7/47 Keep container tightly closed and at a temperature not exceeding... C (to be specified by the manufacturer) S20/21 When using do not eat, drink or smoke S24/25 Avoid contact with skin and eyes Page 51

52 S29/56 Do not empty into drains, dispose of this material and its container at hazardous or special waste collection point S36/37 Wear suitable protective clothing and gloves S36/37/39 Wear suitable protective clothing, gloves and eye/face protection S36/37 Wear suitable protective clothing and eye/face protection S36/37/39 Wear suitable gloves and eye/face protection S47/49 Keep only in the original container at a temperature not exceeding... C (to be specified by the manufacturer) Choice of the most used risk phrases and safety phrases 1 All pesticide labels could usefully carry the following phrases, whatever the toxicological classification: S2, S13, S20/21. 2 For very toxic, toxic and dangerous products: S45 + appropriate R phrases for ways of exposure for which the product has been proven very toxic, toxic or dangerous. 3 For corrosive products: S23, S37, S39. 4 For organophosphonates: S28. 5 For skin irritant products: R38, S24, S37; for eye irritants: R36, S25 6 For products very toxic or toxic to fish: Very toxic to fish (or Toxic to fish ), Do not treat near waterways and pond surroundings. 7 For toxic to bees products: R57 + Do not treat during blossoming Page 52

53 Appendix 3 Pictograms Pictograms indicate graphically a message for safe handling of the products. They must be used on the label pattern of annex 7. Use the number and wording to indicate choice of pictogram. 1 Very toxic/toxic to human beings and to animals 2 Dangerous to human beings and to animals 3 Keep locked away and out of reach of children 4 Use the recommended quantity of the product which is a liquid concentrate 5 Use the recommended quantity of the product which is a solid concentrate 6 Precautions to take for the application of the product 7 Wear gloves 8 Wear boots 9 Wear protection of nose and mouth 10 Wear respirator 11 Wear eye protection 12 Wear protective overalls 13 Wear protective apron 14 Wash after use 15 Harmful to domestic and wild animals 16 Harmful to fish and aquatic organisms; do not pour in waterways, lakes, rivers and points of water Page 53

54 Appendix 4 Acronyms ADI CIPAC BCF CFU Acceptable Daily Intake Collaborative International Pesticides Analytical Council BioConcentration Factor Colony Forming Unit DT 50 Dissipation Time 50 EDI EPPO EPA EU FAO Estimated Daily Intake European and Mediterranean Plant Protection Organization Environmental Protection Agency European Union Food and Agriculture Organization GIFAP International Grouping of National Associations of Agrochemical Product Manufacturers IC 50 Inhibiting Concentration 50 ISO International Standard Organization LC 50 Lethal Concentration 50 LD 50 Lethal Dose 50 MEDI Maximum Estimated Daily Intake MRL Maximal Residue Limit NEL Non Effect Level NOEL Non Observable Effect Level OECD Organization for Cooperation and Development PECswLT Predicted Environmental Concentration - in Surface Waters - in the Long Term PECsLT Predicted Environmental Concentration - in the Soil - in the Long Term PTC Pesticide Technical Committee TER Toxicity/Exposure Ratio UICPA International union of Pure and Applied Chemistry ULV Ultra Low Volume WHO World Health Organization Page 54

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