SPECIFICATIONS FOR PESTICIDES A TRAINING MANUAL

Transcription

1 SPECIFICATIONS FOR PESTICIDES A TRAINING MANUAL Food and Agriculture Organization of the United Nations Specifications_pesticides_A_training_manual_cover - Facilitator.indd 1 17/07/ :00:49

2 Specifications for pesticides: a training manual Facilitator's guide Food and Agriculture Organization of the United Nations

3 WHO Library Cataloguing-in-Publication Data Specifications for pesticides: a training manual. Contents: Participant s guide -- Facilitator s guide 1.Pesticides - standards. 2.Mosquito control. 3.Teaching materials. I.World Health Organization. II.Food and Agriculture Organization of the United Nations. ISBN (participant s guide) (NLM classification: WA 240) ISBN (facilitator s guide) World Health Organization 2013 All rights reserved. Publications of the World Health Organization are available on the WHO web site ( or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: ; fax: ; bookorders@who.int). Requests for permission to reproduce or translate WHO publications whether for sale or for non-commercial distribution should be addressed to WHO Press through the WHO web site ( The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Printed in France. WHO/HTM/NTD/WHOPES/2013.4

4 Contents Page List of abbreviations used in the training course i Acknowledgements ii Background and preparation 1 Suggested timetable 8 Participants evaluation of the course 9 Learning Unit A: Introduction to the course 11 Learning Unit B: Introduction to specifications for pesticides 15 Learning Unit C: Specifications for technical grade active ingredients 18 Learning Unit D: Specifications for formulated pesticides 30 Learning Unit E: Relevant impurities 39 Learning Unit F: Determination of equivalence 48 Learning Unit G: Team exercises introduction 57 Exercise 1: zappacarb relevant impurities 60 Exercise 2: happyfos equivalence 69 Exercise 3: superthrin equivalence 82 Exercise 4: fantasychlor equivalence 107 Final discussion 122 Course evaluation and closure 123 Annex 1. Check list for submission of application for development of FAO and or WHO specifications 124 Annex 2. Calculations to estimate the relevance of certain impurities 131 iii

5 List of abbreviations used in the training course CIPAC CS EC EU GC-FID GHS HPLC-UV IPCS ISO JMPS LC-MS LC- MS/MS LN LOQ M1 M2 OECD OK OL SE TC TK UL USEPA WG WHOPES Collaborative International Pesticides Analytical Council capsule suspension emulsifiable concentrate European Union gas chromatography, using a flame-ionization detector Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations Economic Commission for Europe (UNECE), accessible under the Transport of Dangerous Goods heading at high performance liquid chromatography, using an ultraviolet light absorption detector International Programme on Chemical Safety, a joint programme of WHO, the International Labour Organization (ILO) and the United Nations Environment Programme (UNEP) International Organization for Standardization FAO/WHO Joint Meeting on Pesticide Specifications high performance liquid chromatography, using a mass spectrometer as detector high performance liquid chromatography, using a tandem mass spectrometer as detector long-lasting insecticidal net limit of quantification Manufacturer 1 and/or the supporting data and test methods used by M1, which form the basis of a reference specification Manufacturer 2 and/or the supporting data and test methods used by M2, where a product of M2 is to be tested for equivalence with the corresponding product of M1 Organisation for Economic Co-operation and Development acceptable oil-miscible liquid suspo-emulsion technical material technical concentrate ultra-low volume (ULV) liquid United States Environmental Protection Agency water-dispersible granules WHO Pesticide Evaluation Scheme iv

6 Acknowledgements The trial edition of this document was published jointly by the Division of Plant Production and Protection of the Food and Agriculture Organization of the United Nations (FAO) and the Department of Control of Neglected Tropical Diseases (NTD) of the World Health Organization (WHO). The current version takes into consideration the inputs of participants and the experience gained in using the training manual in more than 20 workshops organized by FAO and or WHO for training of staff of pesticide regulatory authorities in different Member States. The two Organizations wish to thank members of the FAO/WHO Joint Meeting on Pesticide Specifications, CropLife International and AgroCare for their technical contribution to the development of this document. The two Organizations also wish to express their sincere thanks and appreciation to Mr Alan Hill, York, UK, for drafting the trial edition, and to the following individuals for their contribution to this document: Dr Markus Müller, Swiss Federal Research Station, Wädenswil, Switzerland; Dr Olivier Pigeon, Walloon Agricultural Research Centre, Gembloux, Belgium; Dr Rajpal Yadav Singh, NTD/WHO, Geneva, Switzerland; Ms Yong Zhen Yang, Division of Plant Production and Protection, FAO, Rome, Italy; and Dr Morteza Zaim, NTD/WHO, Geneva, Switzerland. This publication was funded through the Bill & Melinda Gates Foundation award to the WHO Pesticide Evaluation Scheme. v

7 Background and preparation Why offer this course? The International Code of Conduct on the Distribution and Use of Pesticides 1 promotes trade in, and use of, good-quality pesticides and discourages the distribution of poor-quality products. Specifications for pesticides are developed by the Food and Agriculture Organization of the United Nations (FAO) and by the World Health Organization (WHO) to enable good- and bad-quality products to be distinguished, using simple, robust and well-validated tests. The Code of Conduct further promotes the use of FAO/WHO procedures for the determination of equivalence. The FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) provides independent expert scientific assessment of the data supporting FAO and WHO specifications. The JMPS has developed standard procedures for assessment of pesticide data, including the determination of equivalence which minimizes the requirements for additional animal testing of pesticide hazards. The principles and practice of JMPS procedures are of utility to anyone involved in setting and ensuring standards for pesticide product quality, especially pesticide registration authorities. However, although simple in principle, JMPS procedures require extensive technical knowledge and expertise in practice, because almost every case is different. Who should take this course? This course is intended for personnel with responsibility for defining and ensuring the acceptability of pesticide product quality. What is the purpose of the course and what are its objectives? The purpose of this course is to provide an introduction to the principles and practice of defining acceptable quality and equivalence of pesticides, to assist both governments and industry to strengthen the underlying procedures required for quality control of pesticides used in agriculture and public health. The course does not address the procedure and requirements for adapting national pesticide registration systems to implement the principles of determination of equivalence, as promoted by the Code of Conduct, 1 but FAO and WHO recognize that this may involve a step-wise approach given the limited resources in many developing countries. The objectives of the course are that participants completing it should understand the principles underlying specifications for pesticide quality control and be able to: apply well-established quality criteria to specific characteristics; apply well-established procedures where quality criteria must be defined case by case; 1 International code of conduct on the distribution and use of pesticides (revised version). Rome, Food and Agriculture Organization of the United Nations, 2002.

8 determine whether or not different sources of an active ingredient, supported by different data, are equivalent; determine the additional evidence or expert advice required to support decisions on equivalence or the acceptability of quality. What approach is used to teach the course? The course is comprised of two main parts. The first is a plenary session, which provides an overview of the principles underlying specifications development and pesticide quality assessment. The second part involves model exercises, with participants working in teams to address typical cases and problems. The teams solutions to each exercise are discussed before moving on to the next, so that lessons learnt can be put to good use immediately. However, the exercises are not repetitive and new problems are posed in each one. This reflects the real-life situation, where every case is different and where some may present decisionmaking problems for which there is no precedent or model. The course offers a step-by-step approach to acquiring the knowledge and skills needed for basic decision-making on development of pesticide specifications. Throughout the course, participants should be encouraged to ask questions and discuss opinions freely. During the exercises, participants should be encouraged to seek external help or clarification (from a facilitator in lieu of a real manufacturer of the pesticide), if required, to reach a conclusion. This simulates real-life circumstances, where the pesticide manufacturer is often required to provide some additional information or clarification, and where it may also be necessary to consult published scientific literature or an independent expert in a particular discipline. This approach reflects the fact that, when dealing with technical data which invariably have some gaps and/or shortcomings, decisions must be based on inputs and opinion from a range of scientific disciplines. The importance of every detail of, or gap in, the data cannot be assessed by a single person, and an experienced team will have learnt to recognize when it requires additional expertise or information. In addition to the technical issues addressed in the course, an underlying theme is to raise awareness of the delicate balance between maintaining the confidentiality of commercially-sensitive information and ensuring transparency of decisionmaking. Adoption of the internationally-recognized JMPS procedures is a first step towards achieving an appropriate balance in this respect. The second step is to maintain clear records of the basis for conclusions. Both are important where the basis for conclusions is not published, because the web of interdependent decisions leading to the overall conclusion may be forgotten quickly in complex cases. The documentation provided for the team exercises is designed to simplify decision-making and encourage recording of the basis for decisions. What are the roles of the local organizer and facilitators? The local organizer s role is to organize all facilities needed for the course and to make arrangements with participants and the facilitators. The role of facilitators is to present the course and provide technical support to the participants. If there is more than one facilitator, the leading facilitator should be a vii

9 specialist in the quality assessment of pesticide products and have previous experience with a participatory, problem-solving approach to training. A strong commitment to this approach is essential to presenting the course effectively. The leader s job will be made easier and the training more effective if supporting facilitators are available to assist, especially during team exercises. Supporting facilitators should have experience in the quality assessment of pesticide products and they, too, must be committed to the participatory, problem-solving approach to training. How many participants are required? In principle, there is no constraint on participant numbers. However, to foster really good interactions with the facilitator, and between participants, participant numbers should not exceed 30. For the exercises, ideally there should be several teams each comprised of about 5 8 participants. As far as practicable, teams should be balanced with respect to experience and expertise and team size may be adjusted to achieve this. Technical content of exercises The exercises are an essential part of the problem-based learning approach used in this course. The problems highlighted in the exercises were selected because of their frequency and/or importance in JMPS practice. The data in the exercises are not identifiable with any particular active ingredient or chemical structure, which minimizes preconceptions, bias and/or potential problems with confidentiality. Participants should be encouraged to use their imagination and follow this through with a logical, scientific consideration of their ideas. Evaluation tables are provided, to assist participants in a logical approach to the evaluation of data and a methodical approach to record-keeping. As in real-life cases, the information initially provided in the exercises is not comprehensive. Considering each criterion in turn, teams should decide whether or not there is enough information to make a rational conclusion with respect to that criterion. One objective of the training is to encourage participants to differentiate between problems which are unimportant and those which, unless resolved, will prevent them from reaching a rational and defensible overall conclusion. Participants are expected to identify gaps or problems in the information provided and to request additional information where the gap/problem prevents a decision being made. Supplementary information is provided in the completed Evaluation tables, which facilitators are intended to use to fill in the gaps or resolve problems. The supplementary information should be provided freely when a team asks the facilitator for help with a particular issue, but it would defeat the objective of the exercise if such details are provided without request. Facilitators are encouraged to record the supplementary information provided to each team, to help in the postexercise discussions. Facilitators should recognize that, as in real-life cases, although the exercises have logical conclusions, different opinions can lead to different conclusions. Commercially-confidential information is not included in the standard exercises. If appropriate, and with strict controls on participation and the maintenance of viii

10 confidentiality, exercises may be conducted using real-life examples, to address locally-important issues. In such an exercise, everyone involved must have legitimate access to the data and no conflict of interest. Such exercises may follow the format of those given in this training manual but they are not part of the FAO/WHO training course and local organizers must accept responsibility for them. Teamwork The multi-faceted nature of pesticide specifications issues requires the combined expertise of a number of experts in various scientific disciplines, working together as an integrated team. Teamwork is therefore a key feature of the training course. However, if required, the following suggestions for the conduct of teamwork sessions (Learning Unit G) may be adapted in accordance with local customs and culture. Participants should work in teams throughout the exercises. Each team should choose its own moderator, to coordinate discussions, and rapporteur, to record team decisions and the reasons for them. A cooperative spirit within teams (and perhaps a competitive spirit between them) may be encouraged by giving them identities. This may be as simple as Team 1, Team 2 and so on, or perhaps an alternative designation appropriate to local custom. All team members should be encouraged to contribute opinions and ideas freely, without fear of embarrassment, so that the team has a range of options to consider, before reaching conclusions. Facilitators and the team moderator should be particularly supportive towards relatively junior or inexperienced members of the team, who may feel uneasy or unsure about contributing their opinions and ideas. All participants should recognize that, in these exercises and in real-life cases, full participation by the whole team will lead to better decisions and fewer mistakes. It may be helpful to remind participants that superficially naive questions from inexperienced members of a team can sometimes challenge experienced members and facilitators to rethink their own assumptions and concepts. Teams should record the reason(s) for their decisions, or identify the information they would require before a decision can be made. The blank Evaluation tables provided are designed to assist teams towards logical overall conclusions. What preparation is needed? If required, the Participant s guide and the Facilitator s guide should be translated into the local language, taking care to avoid introducing changes in the meaning of the text and slides. The course is based upon the FAO/WHO document, Manual on development and use of FAO and WHO specifications for pesticides, 1 which provides a comprehensive coverage of the subject. The FAO/WHO specifications manual is supplemented by procedural updates, published annually in reports of the Joint Open Meetings of the Collaborative International Pesticides Analytical Council (CIPAC) and the JMPS, which are also available through the same web sites. 1 Available only on the Internet at jmps/manual/en/ and htpp:// ix

11 Facilitators should familiarize themselves thoroughly with these reference documents. Before the course, participants should be asked to read the two chapters of the FAO/WHO specifications manual on: Data requirements and procedures; and Aims, applicability and requirements of clauses. Facilitators should refresh their knowledge of the course materials well in advance. They should work together with the local organizer to develop an effective approach for course delivery, discussing goals, objectives, timetable and team exercise dynamics. Lists of participants allocated to each team for the exercises should be prepared for distribution at the beginning of Learning Unit G. Facilitators should recognize the importance of actively stimulating discussion and the use of visual aids, such as flip charts or PowerPoint slides. Facilitators may introduce their own examples or scenarios into learning units, to illustrate the particular points or principles being described. A simple example, reflecting personal experience or something of local importance to the participants, can make a presentation more interesting and memorable. Some such examples may have controversial aspects and therefore facilitators should discuss them in advance with the local organizer, to avoid pitfalls. What facilities, equipment and materials are needed to present this course? Ideally, the course should be residential, to maximize the time available for discussion among the participants and to avoid external distractions. One large room and one or more smaller rooms should be available for training. The large meeting room can be used for plenary sessions and the smaller ones for team exercises. Team members should have face-to-face contact with each other throughout work on the exercises, preferably by sitting around a suitable table. The local organizer should make the general domestic arrangements required by participants and facilitators for the duration of the meeting. The following equipment and materials are needed by facilitators: copies of the Facilitator's guide; name badge(s); laptop computer with compatible projector, together with a screen for presentations, a printer and supply of plain paper. Alternatively, an overhead projector may be used (spare bulb required), together with blank acetate sheets and suitable marker pens. If an overhead projector is used, the completed Evaluation tables, used during the discussion of exercises, will also have to be printed on acetate sheets; flipcharts one for each team and one for the plenary, with marker pens in a selection of colours; blackboard or whiteboard, with chalk/marker pens in a selection of colours and a suitable wiper; access to a photocopier, to copy the exercise pages (pages of this Guide) for each participant. The copied pages should be distributed to participants in the sequence indicated in each exercise of Learning Unit G. x

12 The following equipment and materials are needed by each participant: copy of the Participant s guide; name badge; list of names and affiliations of participants, local organizer and facilitators; course timetable; brief note on local arrangements for meals, breaks, transport, security, emergencies, contacts for general support, etc.; notebook or paper; ballpoint pen and pencil; course evaluation form; tables of data and blank Evaluation tables for exercises (to be distributed immediately before each exercise begins), which are intended to be kept with the Participant s Guide, to complete it as a reference volume; completed Evaluation tables (to be distributed during the discussion session following each exercise), which are intended to be kept with the Participant s Guide, to complete it as a reference volume; course completion certificate, if required by local custom; The following is needed by each team of participants during the exercises: access to a suitable electronic calculator or spreadsheet program, for relevant impurity calculations in Exercise 1 and calculation of averages ± 3 standard deviation in Exercises 2 4. All of the above may be adapted to local requirements. How much time is needed to complete the training? The course requires three days for completion, based on approximately 8-hour working days, including breaks. A suggested timetable is provided below. How is the course evaluated? A questionnaire is provided. It focuses on participants opinions about how the training helped them and how it might be improved. Allow time to conduct the evaluation at the end of the training course, to provide as much feedback as possible. Facilitators should incorporate useful feedback into future training courses. Feedback relating to the contents of this training manual should be relayed to FAO and WHO. Confidentiality Although the standard course in this training manual contains no commercially confidential information, it does address topics that would be considered xi

13 confidential in real-life cases. At the outset therefore, the facilitator should remind participants of the need to avoid inappropriate references to commerciallyconfidential information. Course delivery by the facilitator Ensure that all participants can see clearly the screen and flip charts. Clarity of speaking is essential. A little informality may help participants to feel more at ease but the course is technical and requires their full attention throughout. To avoid distractions, participants should be asked politely to switch off mobile phones and similar devices during course sessions. As far as practicable, maintain face-to-face contact with participants at all times. Try to convey enthusiasm for the subject and a sense of friendliness throughout. Where appropriate, reinforce the information given in the slides with your own or local examples, to maintain interest. The key points of the course must be conveyed, but it is better to leave a little more time for questions than to overrun the timetable by including less important information in the presentation. If the number of participants is large, ask questioners to identify themselves before they ask their first question. If a question is long or unclear, summarize it for participants and confirm with the questioner that you have understood the point before answering. Describe the learning approach that will be used during the course. Explain briefly the role of the team exercises and emphasize that they are not tests or examinations but practical exercises, intended partly to reinforce the learning and understanding and partly to help participants appreciate all aspects of a team s work. In the exercises, ensure that participants understand that there may be no correct answer to some problems. Participants should be encouraged to ask questions for clarification throughout the course, especially during the team exercises. If a question appears naive, or even deliberately unhelpful, the facilitator must not respond dismissively or rudely but thoughtfully and courteously, to maintain the interest and respect of all participants. If you do not know the answer to a question, say so and move on. If necessary, you can check out the answer later, but it is important to avoid wasting time or confusing participants by waffling when you do not know the answer. Participants may wish to express their own views and, if this adds to the value of the course for other participants, they should be allowed to do so. With no correct answer to some problems, opinions will vary and facilitators should encourage consensus-building, based on a logical consideration of all possibilities. Participants views and questions should only be suppressed if they appear likely to disrupt the course timetable or distract focus from the current topic. In such cases, the facilitator should respond, in a pleasant manner, that the question or viewpoint is interesting but that: - it will be dealt with in a later module; or - it is beyond the scope of the course; or - it is too complex to address within the time available; or - it addresses a topic on which there is insufficient knowledge at present. xii

14 SUGGESTED TIMETABLE SPECIFICATIONS FOR PESTICIDES DAY TIME SUBJECT 1 08:30 09:00 Registration, if required, and distribution of course materials 09:00 09:15 Opening ceremony, if required 09:15 10:00 Learning Unit A: Welcome and introduction to the course 10:00 10:30 Learning Unit B: Introduction to specifications for pesticides 10:30 11:00 Break 11:00 12:45 Learning Unit C: Specifications for technical grade active ingredients 12:45 14:00 Lunch break 14:00 15:30 Learning Unit D: Specifications for formulated pesticides 15:30 16:00 Break 16:00 17:15 Learning Unit E: Relevant impurities 2 09:00 10:30 Learning Unit F: Determination of equivalence 10:30 11:00 Break 11:00 11:15 Learning Unit G: Team exercises. Introduction and formation of teams 11:15 11:30 Exercise 1: Introduction and distribution of exercise 1 data 11:30 13:00 Teamwork exercise 1 13:00 14:00 Lunch break 14:00 15:00 Team presentations and discussion, exercise 1 15:00 15:15 Exercise 2: Introduction and distribution of exercise 2 data 15:15 15:45 Break 15:15 16:15 Teamwork exercise 2 16:15 17:30 Team presentations and discussion, exercise :45 09:00 Exercise 3: Introduction and distribution of exercise 3 data 09:00 10:30 Teamwork exercise 3 10:30 11:00 Break 11:00 12:30 Team presentations and discussion, exercise 3 12:30 13:30 Lunch break 13:30 13:45 Exercise 4: Introduction and distribution of exercise 4 data 13:45 15:00 Teamwork exercise 4 15:00 15:30 Break 15:30 16:30 Team presentations and discussion, exercise 4 16:30 16:45 Final discussion 16:45 17:00 Course evaluation and closure 17:00 17:15 Distribution of attendance certificates, if required xiii

15 PARTICIPANT'S EVALUATION OF THE COURSE (Page 1 of 2) Date (dd/mm/yy) I was clear about the purpose of this module The content of this module was relevant to my job and/or professional development There was adequate coverage of the subject The module added to my understanding of the subject The facilitator was knowledgeable about the technical issues in the module Participants questions were answered clearly The documents and visual presentations were fit for purpose The time allocated was adequate The rooms, seating arrangements and equipment were fit for purpose Specifications for technical grade active ingredients and formulations Relevant impurities Equivalence Exercise 1, relevant impurities Exercise 2, equivalence, happyfos Assessment using a 1 to 10 grading scale: Definitely Definitely NO YES Exercise 3, equivalence, superthrin Exercise 4, equivalence, fanatasychlor xiv

16 PARTICIPANT S EVALUATION OF THE COURSE (Page 2 of 2) Module 1. Specifications for technical grade active ingredients and formulated pesticides Comments and suggestions, if any 2. Relevant impurities 3. Equivalence 4. Team exercises Any other comments Thank you for your feedback and cooperation. xv

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18 LEARNING UNIT A Introduction to the course (3/4 hour, including discussions) Slides A-01 to A-06 Welcome the participants and introduce yourself (and any other facilitators), writing your name(s) on the blackboard or flipchart. Ensure that all participants have the materials needed for the course, particularly the Participant s guide. Explain that course evaluation forms and team exercise documents will be distributed later during the course. Check that participants have been able to access the Manual on development and use of FAO and WHO specifications for pesticides and its supplements, either on-line or as hard copy. Present and briefly discuss the following: Slide A-01 Importance of pesticides in food security and quality Pests and diseases are major causes of loss and quality degradation in agricultural production and food storage throughout the world. Migratory pests, such as locusts, can cause particularly dramatic losses within a region. The consequences, in terms of hunger, malnutrition and pressure to cultivate yet more land, are incalculable. Use of pesticides is a very important element in an integrated approach to control agricultural and food pests. Slide A-02 Importance of pesticides in controlling vector-borne diseases Vector-borne diseases are major causes of illness and death in many tropical and subtropical countries. Vector control has a key role in prevention and control of vectorborne diseases such as malaria, dengue and Chagas disease. Use of pesticides is the most important element in an integrated approach to vector control, especially during epidemics. Slides A-01 and A-02. Explain that... (i) These points highlight the importance of pesticides in an integrated approach to pest control. Emphasize that, used judiciously, pesticides are essential tools in improving agricultural production and economies, as well as in vector and public health pest control. 1

19 Slide A-03 Poor-quality pesticides are unlikely to serve their intended purpose; are likely to provide poor value to users; are likely to be more harmful, directly or indirectly, to humans and the environment; may be phytotoxic to treated crops or taint food. The facilitator should insert examples into the following blank slide, A-04, either drawn from local or personal experience or chosen from the examples given below. Slide A-04 Adverse effects of poor-quality pesticides Blank slide: facilitator to insert examples Slide A-04. Examples of adverse effects of poor-quality pesticides... (i) Excessive level of a hazardous impurity increases risks of adverse effects on users, crops, food consumers and/or the environment. (ii) Insoluble particulates present in products intended for spray application may block nozzles and/or filters, delaying operations and increasing the risk of user exposure to active ingredient. (iii) Granular formulations that are too fragile may produce respirable dust when handled and applied, again increasing the risk of user exposure to active ingredient. (iv) Poor suspensibility of dispersions may produce uneven distribution of active ingredient in the spray tank and uneven application. (v) Poor retention or migration of insecticide through successive washes in a longlasting insecticidal net (LN) leads to reduced personal protection of the user. (vi) If poor quality leads to poor efficacy, users may increase dose rates or the number of applications and unknowingly increase other risks. (vii) Users may dump poor-quality products into the environment, with potentially adverse effects on wildlife and drinking-water. (viii) Selectivity may be adversely affected. (ix) Any of the above consequences will usually have a negative impact on the marketability of a pesticide product and its registration could be withdrawn or restricted. Ask participants... (i) If they can describe other examples of direct and indirect adverse effects of poor-quality pesticides, drawn from their own knowledge or experience. As an aside to the Learning unit, but nonetheless very important, remind participants that

20 (i) Even high-quality pesticides must be used carefully and judiciously, for good control of pests and vectors while avoiding adverse side-effects to people and the environment. Slide A-05 Goal of the training course To enable you to make sound decisions about the control of quality of pesticides used in agriculture and/or public health. Slide A-06 Objectives of the training course By the end of this course you should be able to: apply well-established quality criteria for specific characteristics; apply well-established procedures where quality criteria must be defined case by case; determine whether or not different sources of an active ingredient, supported by different databases, are equivalent; determine the additional evidence or expert advice required to support decisions on equivalence or the acceptability of quality. Slide A-06. Explain that... (i) The purpose of this course is to provide an introduction to the principles and practice of defining acceptable quality and equivalence of pesticides, to assist both governments and industry to strengthen the underlying procedures required for quality control of pesticides used in agriculture and public health. The course does not address the procedure and requirements for adapting national pesticide registration systems to implement the principles of determination of equivalence, as promoted by the Code of Conduct, 1 but FAO and WHO recognize that this may involve a step-wise approach given the limited resources in many developing countries. (ii) The principles and procedures described in this course have been developed by the JMPS. Although FAO and WHO are not international regulatory authorities, the JMPS principles and procedures are expected to be broadly applicable within most regulatory systems. Part of the overall purpose is therefore to encourage harmonization of registration requirements and procedures. (iii) The technical issues involved in dealing with each active ingredient and formulation tend to differ, and therefore the JMPS procedures must be applied intelligently and according to the requirements of each particular case. However, the following general principles are applicable in all cases: (a) maintenance of commercial confidentiality; 1 International code of conduct on the distribution and use of pesticides (revised version). Rome, Food and Agriculture Organization of the United Nations,

21 (b) transparency of decision-making procedures; (c) basing decisions on inputs from a team of scientists with expertise and experience in a range of appropriate disciplines; (d) basing decisions on sound science and the best evidence available; (e) keeping clear records of decisions and the rationales for decisions, especially where the decisions are made case by case. Before finishing this brief introduction... (i) Inform participants that pages from the Participant s guide for Learning Unit G will be distributed during the exercises and should be inserted at that time, forming a complete reference volume by the end of the course. (ii) Ask participants if there are topics of particular importance or interest to them that they would like to see covered within the course. Explain that it is not practical to address completely new topics, or to extend the course timetable. List the topics on a flipchart. During the final discussion session, you and the class can return to this list and see whether topics which can be addressed have been covered adequately. (iii) Inform participants that course completion certificates, if required, will be available after the closing ceremony. 4

22 LEARNING UNIT B Introduction to specifications for pesticides (1/2 hour total, including discussion) Slides B-01 to B-05 Present the objectives of this Learning unit Slide B-01 Learning objectives After this Introduction, you should understand: What is a pesticide specification, its aim and general requirements? Present and discuss the following: Slide B-02 What is a pesticide specification? A list of basic quality criteria for distinguishing between products having acceptable and non-acceptable quality (of the same type). It does not define the best product, nor that the product is suitable or safe for a particular purpose. Slide B-02. Explain that... (i) A pesticide specification does not include all possible chemical and physical properties of a pesticide product but only the parameters critically related to their identity and quality. (ii) A specification should be brief but unambiguous and supported by appropriate test methods. (iii) Safety and suitability for purpose are the responsibility of registration authorities. (iv) Deciding which product is the best available for the purpose is the responsibility of the buyer or the buyer s advisers. Slide B-03 A pesticide specification includes criteria for properties in some or all of the following categories... description of the product active ingredient identity and content relevant impurities physical properties storage stability Slide B-03. Explain that... 5

23 (i) These categories and criteria will be addressed in more detail later in the training course. (ii) Specifications do not include clauses to control inherent properties of the active ingredient, which are not influenced by product quality. Information on such properties is provided in the evaluations which are published in support of FAO and WHO specifications. Slide B-04 Test methods supporting specifications Widely-accepted, well-validated test methods are essential. Test methods should be straightforward and robust. Well-trained technicians and a suitably-equipped laboratory are required for reliable results. Slide B-04. Explain that... (i) Clearly defined, widely-accepted and/or well-validated methods are essential for making reliable, reproducible and comparable physical and chemical measurements. This is true both for developing specifications in the first place and for subsequent compliance testing. In the case of physical tests, methods must be applied without deviation, because the physical properties involved are defined by the method of measurement. (ii) Various international organizations provide the means by which test methods can be validated to an acceptable standard. CIPAC has provided the majority of well-known methods for compliance testing of physical and chemical properties of pesticide products (see Other organizations such as AOAC International and ASTM International also provide methods. Test methods for the physical properties of active ingredients tend to be those adopted by OECD, USEPA and the EU but, while these methods provide important supporting information for evaluating specifications, they are not appropriate for compliance testing because pesticide specifications do not define the properties of the active ingredient. Slide B-05 FAO and WHO specifications FAO and WHO specifications are international points of reference for quality of agricultural pesticides (FAO) and public health pesticides (WHO). FAO/WHO development of specifications has changed to a new procedure in recent years. Slide B-05. Explain that... (i) FAO/WHO specifications form international points of reference in those cases where the standards have been developed. For pesticide products for which FAO/WHO specifications do not exist, the general provisions of the FAO/WHO specifications manual apply. Although more limited and less detailed in scope, the provisions of the FAO/WHO specifications manual provide certain basic points of reference which are expected to apply to most, if not all, pesticide products. 6 16

24 Specifications for pesticides: a training manual Facilitator s guide SPECIFICATIONS FOR PESTICIDES: A TRAINING MANUAL (ii) The "new" procedure for development of pesticide specifications, which was introduced by FAO in 1999 and by WHO in 2002, links specifications to the products of manufacturer(s) whose data package(s) on the manufacturing process and chemical and hazard profiles have been evaluated by the JMPS. In contrast, FAO and WHO specifications developed under the old procedure apply to the products of all manufacturers, irrespective of whether or not their products had been evaluated. Evaluations conducted under the old procedure were also less detailed than those of the new procedure. Existing FAO and WHO specifications developed under the "old" procedure remain valid until reviewed under the "new" " procedure. (iii) Check list and data requirement for submission of application for development of FAO and or WHO specifications are presented in Annex 1. (iv) FAO/WHO specifications alone are not sufficient to establish equivalence at national level. Establishment of, and access to data/information of reference profile is essential for this purpose, as it will be discussed later in the course. Ask participants if they have any questions. 7

25 LEARNING UNIT C Specifications for technical grade active ingredients (1½ hours presentation plus ¼ hour discussion) Slides C-01 to C-22 Present the objectives of this Learning unit. Slide C-01 Learning objectives After completing this Learning unit, you should understand: the structure and aims of specifications for technical grade active ingredients and their role in the development of specifications for formulated products; data requirements for developing specifications for technical grade active ingredients and why it may be necessary to work with incomplete information; the need for confidence in the validity of data evaluated; the concept of reference profile ; the importance of openness and transparency in decision-making, while maintaining confidentiality of secret information. Slide C-02 Specifications for technical grade active ingredients Technical grade pesticides are relatively pure active ingredients, used to prepare formulations. TC = technical material; TK = technical concentrate. TC is usually 900 g/kg active ingredient, with solvent(s) removed during synthesis and no solvent added subsequently. TK contains <900 g/kg active ingredient and may contain solvents or diluents. Slide C-02 Explain that... (i) TC and TK are international codes for technical grade active ingredients, as defined by the CropLife International coding system, e.g. deltamethrin TC 985 g/kg and pyrethrum TK 200 g/kg; (ii) Some technical grade active ingredients do not clearly fall into either of these categories and may require expert judgement; (iii) TC is usually the final product from preparation of the active ingredient, which may contain a stabilizer and/or anti-caking or anti-static agents (if required) but no other additives. It is the purest form of active ingredient that is economic for use in formulations. 8

26 (iv) TK may also be the final product from preparation of the active ingredient but it may contain additives (not formulants) in addition to a stabilizer, for example as safety agents. TK may also contain solvent(s), (including water), either deliberately added to a TC or not removed during preparation. TK may be preferred where TC preparation is uneconomic, unnecessary, particularly hazardous or destabilizes the active ingredient. Slide C-03 Why distinguish between TC and TK? TC specification has only a lower limit for active ingredient content; TK specification has upper and lower limits; Increasing the purity of a TC does not increase its hazard significantly and may rather decrease it; Higher content of active ingredient in TK may increase hazard. Slide C-03 Explain that... (i) Both TC and TK specifications have lower limits for active ingredient content, but TK specifications have also an upper limit. (ii) The terms hazard and risk tend to be defined similarly, or used interchangeably, in many dictionaries and some technical literature. For those involved in hazard and risk assessment, as well as for the purposes of developing pesticide specifications, the terms are applied with different meanings. Various definitions of both hazard and risk have been proposed to clarify the distinction, but the following definitions have been published by IPCS. 1 Hazard: an inherent property of an agent or situation having the potential to cause adverse effects when an organism, system, or (sub)population is exposed to that agent. Risk: the probability of an adverse effect in an organism, system, or (sub)population in reaction to exposure to an agent. (iii) FAO and WHO wish to encourage production of the highest purity active ingredients, because an increase in active ingredient content (say) from 900 g/kg to 990 g/kg in a TC will not significantly increase hazards due to active ingredient (because the content is raised by only 10%), whereas hazards associated with impurities may be greatly reduced (on average by a factor of 10 in this case). (iv) The concentration range in a TK represents compromise for economic synthesis of an active ingredient, stability in storage and transportation, suitability for subsequent formulation and control of hazard. The upper limit in a TK specification will ensure that the TK hazard cannot be increased significantly (potentially by more than 10%), should the content of active ingredient be unexpectedly high. 1 International Programme on Chemical Safety. IPCS risk assessment terminology. Part 1: IPCS/OECD key generic terms used in chemical hazard/risk assessment. Part 2: IPCS glossary of key exposure assessment terminology. Geneva, World Health Organization, 2004 (available at: accessed April 2013). 19 9

27 Slide C-04 Importance of developing specifications for technical grade active ingredients Pesticide formulations are generally produced from technical active ingredients. Specifications should be related to the hazard data for the source of active ingredient under consideration. Slide C-05 Information to support specification for technical grade active ingredient of a specific source Active ingredient identity; Manufacturing route, materials and conditions; 5-batch analytical data and manufacturing limits; Methods of analysis. Slide C-05 Explain that... (i) Identity is defined by a common name which is allocated by the International Organization for Standardization (ISO). Some active ingredients consist of isomers; the composition of these isomers must be clearly identified and needs to conform with those defined by international organizations, such as ISO. (ii) The information on the manufacturing process and starting materials is indispensable to fully understand the 5-batch analysis data and manufacturing limits; (iii) Analytical methods and their validation data are required to determine the content and identity of active ingredient and impurities, in support of 5-batch analysis data and the manufacturing limits. Slide C-06 Information to support specification for technical grade active ingredient of a specific source Physico-chemical characteristics of pure and technical grade active ingredient; Guidelines including sub-methods for determination of physicochemical characteristics. Slide C-06 Explain that... (i) Data on physico-chemical characteristics, such as vapour pressure, melting point and octanol-water partition coefficient of the pure and technical grade active ingredient are required to develop specifications for technical grade active ingredient and formulations. For example, a fast hydrolysis, at a certain ph, may justify limiting ph range in the specifications; or dissociation characteristics may influence the behaviour of the active ingredient under specific analytical conditions. 10

28 Slide C-07 Information to support specification for technical grade active ingredient of a specific source Full toxicology and ecotoxicology data package Slide C-07 Explain that... (i) Data on acute, sub-chronic and chronic toxicity based on the purity of the material under consideration and elaborated using generally accepted guidelines are required. (ii) FAO and WHO would require a letter of access to a national registration authority, as a requirement for development of specification, for comparison of manufacturing process, purity/impurity profile to that submitted for registration in a given country. This is to ensure that the risks of using the material in one or more applications, have been assessed as acceptable by at least one more national authority. It is very important to recognize that this does not mean that risks will be acceptable in all possible use scenarios. All registration authorities should satisfy themselves that the risks involved in the intended uses of a particular product within their country or region are acceptable before permitting such uses. Slide C-08 Data are evaluated to... Verify minimum purity of the active ingredient; Identify relevant impurities and their limits; Establish reference profile ; Ensure that specification clauses and limits are valid quality criteria and supported by evidence. Slide C-08 Explain that... (i) Relevant impurities are by-products of the manufacture or storage of an active ingredient which, compared with the active ingredient, are toxicologically significant to health or the environment, phytotoxic to treated crops, cause taint in food, affect the stability of the pesticide, or cause any other adverse effect. Water may be a relevant impurity if it can adversely affect pesticide stability or formulation quality. Insoluble material may also be a relevant impurity in a TC or TK if the subsequent formulations would fail a wet sieve test and be likely to block sprayer filters and nozzles in use, for example. Relevant impurities will be dealt with more fully in Learning Unit E. (ii) Reference profiles are the purity/impurity, physico-chemical and hazard data associated with active ingredient from the source that is supported by the most comprehensive hazard data available. The reference specifications also relate to the product from this source. Reference profiles are used for the determination of equivalence, which is addressed in Learning Unit F. 11