Workshop Proceedings Southern African Pesticide Regulators Forum (SAPReF) Regional workshop on risk reduction of Highly Hazardous Pesticides (HHPs) and technical assistance training for implementation of the Rotterdam Convention Holiday Inn - Rosebank, Johannesburg, South Africa 25-29th April 2016 TABLE OF CONTENTS SOUTHERN AFRICAN PESTICIDE REGULATORS FORUM (SAPREF) HIGHLY HAZARDOUS PESTICIDE (HHP) WORKSHOP ................................................................................................................... 4 BACKGROUND ........................................................................................................................... 4 CONTEXT .................................................................................................................................. 5 OBJECTIVES OF WORKSHOP ....................................................................................................... 6 INTRODUCTION AND PARTICIPANTS ............................................................................................ 7 DAY 1 – APRIL 25TH 2016: OPENING SESSIONS ............................................................................... 8 Welcoming Remarks .................................................................................................................................... 8 SAPReF Chair ......................................................................................................................................... 8 Food and Agriculture Organisation of the United Nations - South Africa (FAO-SA) ................... 8 Guest of Honour .................................................................................................................................... 9 University of Cape Town (UCT) ........................................................................................................ 10 Swedish Chemical Agency (KemI)..................................................................................................... 10 Framing the Workshop.............................................................................................................................. 10 Workshop objectives, programme, housekeeping matters ............................................................ 10 Highly hazardous pesticides – Why do we worry and what can we do? ....................................... 12 The Mozambique pilot project: Reducing the Risks of HHP ......................................................... 14 Overview of country information relevant to the management of HHPs .................................... 16 Understanding Hazards vs. Risks ...................................................................................................... 18 Identification of HHPs: The criteria .................................................................................................. 21 Using the Pesticide Registration Toolkit to enable identification of HHPs ................................. 23 End of Day 1 Key Summary.................................................................................................................. 25 DAY 2 – APRIL 26TH 2016: IDENTIFICATION OF HHPS .................................................................. 26 Review of Individual Pesticides and Discussion on Methodology ........................................................ 26 Harmonized methodology for identification of HHPs in SAPReF? ............................................... 26 End of Day 2 Key Summary ....................................................................................................................... 27 DAY 3 – APRIL 27TH 2016: HHP USE SURVEY & RISK ASSESSMENT METHODS ................................ 28 HHP Use Surveys........................................................................................................................................ 28 HHP use survey – objectives and methods....................................................................................... 28 Methods of Risk Assessment ..................................................................................................................... 31 Risk assessment – options and methods for human health and environmental risk assessment............................................................................................................................................ 31 End of Day 3 Key Summary ....................................................................................................................... 34 2 DAY 4 – APRIL 28TH 2016: RISK MITIGATION ...............................................................................35 Risk mitigation: options and constrains: Assessment of (non-chemical) alternatives ....................... 35 Risk mitigation – options and constraints ........................................................................................ 35 Assessment of alternatives – options and constraints..................................................................... 36 Regional coordination and collaboration for HHP risk reduction ..................................... 39 Rotterdam Convention: Implementation Article 5 under information exchange .............................. 39 Connecting it all with the Rotterdam Convention .......................................................................... 39 Implementing article 5 under information exchange and PIC procedure .................................... 41 Implementing article 6 for SHPF (Severely Hazardous Pesticide Formulations) ........................ 43 Addressing challenges identified by the countries and way forward ............................................ 45 End of Day 4 Key Summary ....................................................................................................................... 46 DAY 5 – APRIL 29TH 2016: PLAN DEVELOPMENT .......................................................................... 48 Developing Action Plans and Regional Strategy ..................................................................................... 48 FAO – Africa Solidarity Trust Fund Project...................................................................................... 52 SADC Regional Guidelines for the Regulation of Crop Protection Products in SADC Countries (2011) – Need for review? .................................................................................................. 53 WORKSHOP RECOMMENDATIONS ............................................................................................. 54 ANNEX 1: WORKSHOP AGENDA ..................................................................................................55 ANNEX 2 - LIST OF PARTICIPANTS AT SAPREF HIGHLY HAZARDOUS PESTICIDE WORKSHOP .......... 61 ANNEX 3 – TERMS OF REFERENCE FOR THE TECHNICAL WORKING GROUP AND THE CONSULTANT FOR THE REVIEW OF THE REGIONAL GUIDELINES FOR THE REGULATION OF PLANT PROTECTION PRODUCTS IN SADC (2011) UPDATE WORKING GROUP.............................................................. 65 3 SOUTHERN AFRICAN PESTICIDE REGULATORS FORUM (SAPREF) HIGHLY HAZARDOUS PESTICIDE (HHP) WORKSHOP BACKGROUND The Southern African Pesticide Regulators’ Forum (SAPReF) was formed in 2011 and current membership includes pesticide regulators and/or Designated National Authorities (DNA) of the Rotterdam Convention, pesticide risk managers from diverse backgrounds and disciplines from all the 15 SADC countries (Angola, Botswana, Democratic Republic of Congo (DRC), Lesotho, Malawi, Mauritius, Madagascar, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe) as well as technical experts from key supporting institutions (Food and Agriculture Organisation of the United Nations (FAO), University of Cape Town (UCT), Swedish Chemical Agency (KemI) and the SADC Secretariat). Currently there are over 100 members on the SAPReF platform registered and participating as members, administrators or observers. SAPReF seeks to achieve sound management of pesticides and biopesticides used in agriculture, public health and domestic environments. Its members also address policies and practices for sustainable pest management that aim to reduce reliance on chemical pesticides. In 2014 SAPReF was endorsed as a subcommittee of the SADC-SPS Committee under the Plant Protection Technical committee. The priority areas identified in the SAPReF Strategic Action Plan that was elaborated in July 2015 include regional projects and programmes to reduce risks posed by Highly Hazardous Pesticides (HHPs), promotion of safer alternatives to toxic chemical pesticides, strengthening of implementation of various multilateral environmental agreements (MEAs) pertaining to sound pesticide management such as the Basel, Stockholm and Rotterdam Conventions, capacity building for sustainable pest and pesticide management and harmonization of pesticide regulation procedures, to name a few. 4 CONTEXT In July 2015, FAO through 3 projects (Africa Solidarity Trust Fund, Rotterdam Convention Secretariat and the EC funded project on strengthening implementation of the Multilateral Environmental Agreements) supported a regional workshop for SAPReF. The workshop objectives were to: Elaborate a strategic action plan for SAPReF (2-5 years) to guide short and long term activities as well as to be used for resource mobilization; To provide some technical training to support implementation of the Rotterdam Convention; Strengthen regulatory capacity and promote better pesticide management. During the Strategic Action planning workshop, countries neighbouring Botswana and Mozambique had some side meetings to discuss the possibility to scale up the work done to reduce risks posed by HHPs done in Mozambique to other neighbouring countries but taking a regional approach. These discussions were followed up with a formal request from SAPReF for financial and technical support for selected countries for risk reduction of HHPs at national level and explore opportunities for a regional approach to eliminate HHPs. Appreciating that the key priority areas in the SAPReF Strategic Action Plan fall within the scope of the EC funded project on Capacity-Building Related to Multilateral Environmental Agreements in ACP Countries – Phase 2 (“ACP/MEAs 2”), SAPReF made a formal request to FAO through the MEAs project for technical and financial support to regional efforts to reduce risks from HHPs at national level and also to explore opportunities for a regional approach to phase out HHPs. The request was granted and culminated in the SAPReF HHP workshop held in Johannesburg, South Africa from 25th to 29th April 2016 involving all the 15 SADC countries. The goal of this workshop was to foster the regional harmonisation of HHP regulation by providing national regulators with the technical skills and knowledge to develop protocols for the identification and risk management of HHPs in line with the Rotterdam Convention. 5 OBJECTIVES OF WORKSHOP The workshop objectives were to: Discuss a regional strategy on HHPs; Capacity building on Rotterdam Convention implementation; Provide training to the participating countries in the protocol for identification; Discuss risk management of HHPs and to follow up on Rotterdam Convention implementation activities as agreed in action plan 2015; and Develop national HHP risk reduction plans and strategies. 6 INTRODUCTION AND PARTICIPANTS The Highly Hazardous Pesticide workshop for the Southern African Pesticide Regulators Forum (SAPReF) was held in Johannesburg, South Africa from 25-29th July, 2016 with technical and financial support from FAO through the GCP/INT/153/EC funded Capacity-Building Related to Multilateral Environmental Agreements in ACP Countries – Phase 2 (“ACP/MEAs 2”) and the Rotterdam Convention Secretariat. The workshop was attended by 44 participants that included pesticide regulators and Designated National Authorities (DNAs) for the Rotterdam Convention from all 15 Southern African Development Community countries, collaborating partners such as UCT, KemI. The Africa Institute (Regional Centre for the Basel and Stockholm Convention) and the SADC Secretariat showed their support for the workshop. The full list of participants is in Annex 1. “Addressing pesticide use and identification of common issues in managing and reducing pesticide risk in Southern Africa.” 7 DAY 1 – APRIL 25TH 2016: OPENING SESSIONS Welcoming Remarks The master of Ceremony for the Opening Session, SAPReF vice Chairman, Mr David Kapindula facilitated self-introductions by all the participants. SAPReF Chair Loitseng Sebetwane Loitseng Sebetwane, the SAPReF Chair, highlighted that the risk reduction of HHPs is part of the SAPReF strategic plan drawn up during the Strategic Planning meeting held in Harare, July 2015. He further went on to stress the importance of harmonisation of HHP regulation amongst SADC member States. Mr Sebetwane went on to give Mozambique as an example of a country that has begun the process of restricting HHPs and that without the harmonisation of restrictions and regulations of neighbouring States their efforts will be wasted. Food and Agriculture Organisation of the United Nations - South Africa (FAO-SA) Tobias Takavarasha The Food and Agriculture Organisation of the United Nations (FAO-SA) Representative for South Africa, Dr Tobias Takavarasha welcomed all the participants and thanked them for their attendance. Dr Takavarasha mentioned that Agriculture is one of Southern Africa’s most important sectors, contributing to 8% of the SADC region’s Gross Domestic Product (GDP) which rises above 28% when all middle income countries are excluded. 61% of the region’s 277 million people living in rural areas, depending on agriculture for their livelihood. Agriculture also employs over 80 percent of the rural population, the majority of who are poor. He further mentioned that women make over 50% of rural populations and play an integral role in the production, harvesting, processing, storage and marketing of food. As a result SADC member states are committed to ensuring enhanced contribution to agricultural development and food security by women, youth and other vulnerable groups by guaranteeing them access to productive resources, services (including sustainable production techniques) and social/economic opportunities. Dr Takavarasha highlighted that with the exception of antipersonnel chemicals such as war gases, pesticides are the only toxic chemicals that we deliberately release into the environment, which, by definition are intended to cause harm to some living organisms. He further emphasised that developing countries are facing growing domestic and international concerns about pesticide use and associated risks due to the 8 environmental and health hazards they create from their expanding use and weak of national regulatory agencies. There is a need to change pest management practices to more sustainable approaches with reduced reliance on pesticides, and to strengthen regulatory control on the distribution and use of pesticides to reduce risk of harm to people and the environment. An efficiently regulated and managed pesticide registration scheme is a prerequisite for ensuring that pesticides used in the country are effective for controlling pests and will not cause adverse effects to humans and the environment. He pointed out that FAO has for over 3 decades actively assisted governments, the private sector and others manage pesticides better through international standards and guidelines, legislation reviews, projects for sound life cycle management of pesticides, phasing out Highly Hazardous Pesticides as well as provision of various pesticide management tools. Dr Takavarasha expressed pleasure in the growth of SAPReF and in its efforts to strengthen and foster regional collaboration for sound pesticide management, conveying the importance for SADC States to harmonize their pesticide regulatory management as far as possible in order to stay competitive in the international marketplace, improve trade and protect health of their populations and the environment against poor quality and highly hazardous pesticides. He further went on to emphasising that through regional collaboration, SADC countries have the opportunity to work together more closely, share resources thus lowering the costs of pesticide registration, and coordinate implementation of a number of international conventions related to pesticides such as the Rotterdam, Stockholm or Basel Conventions. He concluded by thanking the European Union for its support in building the capacity of ACP countries to better implement the Multilateral Environmental Agreements relevant to sound chemical management and to FAO for organizing the workshop and also expressed his sincere gratitude to the Swedish Chemical Agency and the University of Cape Town for cofinancing the workshop. Guest of Honour Republic of South Africa Official Mr Nkoane Madumise from the South African Department of Environmental Affairs (DEA) welcomed all participants on behalf of the guest of honour. He further went on to wish everyone a fruitful workshop. 9 University of Cape Town (UCT) H-Andrea Rother - UCT Environmental Health Division Associate Professor H-Andrea Rother highlighted that UCT is strongly committed to capacity building for SAPReF and that the Advanced Post Graduate Diploma in Pesticide Risk Management (DPRM) programme focusing on the life cycle is symbolic of the collaboration with the Swedish Chemical Agency (KemI) and FAO to build capacity for risk reduction of pesticides. Collaboration between supporting agencies and countries is the key to risk reduction. UCT also plays a large role in knowledge translation between SAPReF Member States and supporting organizations with the aim of increasing the exchange and utilization of evidence-based research findings. Swedish Chemical Agency (KemI) Lilian Törnqvist - KemI Dr. Lilian Törnqvist a Senior Scientist within KemI emphasised that HHP regulation is not only a regional issue but global one. She pointed out that it is currently a significant topic on the European agenda, with countries within the European Union working harmoniously to share information and regulations. Ms Törnqvist went on to highlight that KemI will continue to support SAPReF with its efforts of harmonising registration and procedures. Framing the Workshop Workshop objectives, programme, housekeeping matters Francesca Mancini – FAO AGPMC Dr Mancini a Pest and Pesticide Management Programme Specialist for the FAO highlighted that this is a step wise approach to developing an action plan to build the capacity to create their own in country plan. The regional action plan will help to guide national plans, as countries have pores boarders and require inter collaboration. Dr Mancini broke down the layout of the workshop into: Basic theory, Identification HHPs, Use of HHP surveys and Risk assessment methods, Risk mitigation and the Development of an Action Plan. She went on to outline the workshop strategy: Day 1 Why focus on HHPs Look at the Mozambique case study: what has happened, what has operated and what they have achieved Overview of country information provided by participants 10 Understanding Hazard vs Risk: Criteria to identify HHPs and the Pesticide registration tool kit Day 2 Identification of HHPs: review of individual pesticides and discussion on methodology Hazard Mapping Day 3 HHP use survey: objectives and methods: Field survey and questionnaires Risk assessment methods: Overview of types/methods of performing risk assessments Day 4 Risk mitigation: options and constrains: Assessment of (non-chemical) alternatives Rotterdam Convention: Implementation Article 5 for Notifications of Final Regulatory Actions for Banned or Severely Restricted Chemicals. Information exchange and PIC procedure; Rotterdam Convention: Implementing Article 6 for SHPF (Severely Hazardous Pesticide Formulations) proposal Day 5 Developing the National HHP Action Plans Regional Strategy: SADC Regional Guidelines for the Regulation of Crop Protection in SADC countries (2011) and FAO Africa Solidarity Trust Fund Project (ASTF project) There is a need for countries to communicate and that the first two conventions are interlinked as they influence each other. 11 Highly hazardous pesticides – Why do we worry and what can we do? Francesca Mancini – FAO AGPMC “Highly Hazardous Pesticides (HHP): means pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as WHO or GHS or their listing in relevant binding international agreements or conventions. In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.”1 Dr Mancini emphasised that we can not only depend on the above definition. HHPs are: often are older generation, off-patent products that are relatively cheaply available; frequently remain registered in Low and Middle Income Countries (LMICs) only; often used in these countries not as per label instructions; and cause a lot of poisoning. Francesca underlined that a lot of chemicals posing risks have been banned in high income countries but are still being used in low- and –middle income countries. Why regulate HHPs: There are many costs involved with HHPs both direct and indirect, such as farmers taking numerous days off due to exposer, cost to public health, loss of wildlife and decontaminating the environment. At global level the need to address HHPs is growing in line with Agenda 2020. 2006 – Council endorsed FAO participation in SAICM: progressive banning of HHPs. 2008 - (FAO/WHO) JMPM formulated 8 criteria for the identification of HHPs 2013 - The Code of Conduct was revised to include a definition of and specific reference to HHPs 2014 – Strategy for Global Action on HHPs was prepared by FAO/WHO/UNEP in the context of SAICM 2015 – The Africa Group at SAICM/ICCM4 explicitly asked for concrete action to address HHPs 2016 – Guidelines on HHPs published – the whole w/shop is guided by the guidelines Articles in the Code of Conduct referencing HHPs are: 3.6, 5.1.6, 6.1.1, 7.5, 9.4.1 1 FAO & WHO. 2014. The International Code of Conduct on Pesticide Management. FAO/WHO. Pg.4. 12 HHPs Guideline Objectives are: to help national or regional pesticide regulators with limited resources to design processes to address HHPS that follow 3 steps. 3 Steps of the Guideline: 1) Identify the HHPs through the 8 criteria; 2) Risk Assessment of both exposure levels and need and make informed decision of the impact/cost of removing the HHP from use; and 3) Mitigation - end use, restricting use, change formulation, packaging or use, change or amend policy. Countries that do not have strong capacity to effectively control the distribution and use of pesticides in the country may instead wish regulate the import, manufacture and distribution of HHPs at the “entry points” into the country (through the registration and import control processes). Regional collaboration can assist strengthening the capacity of HHP risk reduction. Regional decisions will impact on national decisions as cross border activities affect each other. UNEP has a special programme providing funding of up to USD500,000 for capacity building and strengthening legislation. The call for proposals is currently open. Question and Answer Section Q: FAO is the international organisation trying to find safer alternatives to HHPs. What is being done for aldicarb which is known to be a HHP? A: Through the SAICM project and Mozambique FAO works at identifying HHPs and finding alternatives. They often happen at different levels. In Mozambique one of the chemicals we have looked at but not limited too is aldicarb. In Mozambique we are next looking at enforcement of the restriction of these products. GEF project is focusing on strengthening capacities through training and tools. A: aldicarb was banned in SA in 2012 because it was being misused. South Africa is still finding data on suicides linked to aldicarb, this may be due to cross-border trade illegally and lack of enforcement. Q: Looking at the level of chemical risk HHP – how can one distinguish between different formulations of one active ingredient identified as an HHP; is the risk the same for all the formulations? A: The methodology of identifying an HHP allows for the same ingredient registered in different formulations to be assessed differently. This way informed decisions can be made. Q: Can we try and control the illegally traded aldicarb by identifying the sources? A: Yes, we need a regional approach to stem the illegal trade of pesticides such as aldicarb and methamidophos, which was banned as HHP in Mozambique but is now being illegally imported into the country from neighbouring countries. 13 The Mozambique pilot project: Reducing the Risks of HHP Khalid Cassam – FAO Mozambique This was a project supported by SAICM and FAO. Project Outline: 1) Identification of HHPs, 2) Conduct field surveys of identified HHPs to assess actual use and exposure, 3) Develop and action plan to reduce this risk, 4) Initiate implementation of action plans (priority risk reduction activities), and 5) Review the results of risk reduction activities; and develop mid- and long-term policies, programmes and projects to reduce the risk of HHPs in Mozambique Methodology and Results Step 1: Identification of HHPs: Pesticide products registered in Mozambique - 648 products, 194 active ingredients were assessed Evaluated HHPs against criteria – reviewed all pesticides authorized in Mozambique against the JMPM HHP criteria: i) WHO classes Ia & Ib; ii) GHS categories 1a & 1b for carcinogenicity, germ cell mutagenicity and reproduction toxicity; iii) Stockholm Convention: Annex A & B, and pesticides meeting criteria of Annex D; iv) Rotterdam Convention: Annex III; v) Montreal Protocol; and vi) high incidence of severe or irreversible adverse effects on human health or the environment. Listed HHPs and other pesticides “coming close” to HHPs (including non-registered but used HHPs) – 59 products (2.6 a.i.) met the criteria and 54 products (16 a.i.) close too or provided concerns Evaluated import statistics Shortlisted HHPs for field surveys Step 2: Reviewed how products are used: Performed field surveys on use and exposure – quantities used and methods of application Additional hazard and risk assessments Identified HHPs requiring risk reduction measures Step 3: Risk reduction plans Shareholder meetings Developed 3 level action plan- Immediate, medium and long term action plans. Step 4: Initial Implementation Initiate implementation of priority risk reduction activities 14 A year after the process began there have be complaints from pesticide companies regarding 3 chemical: Paraquat, 2,4 – D, and Diuron, stating that alternatives are too expensive and not easily available. Question and Answer Section Q: Can we not control the movement of banned HHPs by looking at the place of origin; for example for Paraquat? Or the country they are coming from. A: All countries have legislation and regulation however our borders are so wide and cannot be control. So once we ban them the informal market begins to thrive as they see this as a good business opportunity to get into the market as the farmers need it. If one country bans the product and the next door neighbour does not, it become redundant as the chemicals need to be smuggled from next door. This is why we need regional collaboration and agreements where all regional States communicate and ban/restrict the same products to eliminate them from the region. Q: When you talk about alternatives to products such as paraquat these are some of the questions that had to be considered i.e., what about the prices and the systems in place for regulation at the border? Alternatives are deemed to be expensive so people do not want to use them. A: For now the safer products are expensive because they are not used they are not being sold. If you begin to use the products the price will go done. This is something to think about. A: To begin with; it’s not such a bad thing that pesticides are not so cheap. However, when people compare costs of chemical pesticides and non-chemical alternatives, they fail to take into consideration ‘externalities’ which are costs such as man hours lost due to pesticide poisoning related illness, loss of ecosystem services, pollution to groundwater and other natural resources. Through demonstration, such as with IPM Farmer Field Schools, farmers can test for themselves and see the full benefits of adopting safer alternatives Q: What approach did Mozambique use? In some of the countries parents are initiating their children into the use of agricultural pesticide use A: It was a process of educating everyone on the hazards and risk posed by pesticides and the benefits of proper regulation. So it is very important to do awareness raising, which pesticides to use, how to use the pesticides and when to use the pesticides. There is a need for farmers to learn to assess when to apply pesticides because they usually see only a few pests and the want to use pesticides on everything even when they do not have to. We also worked closely with industry to aid in the elimination and restriction of HHPs. 15 Q: 1) Did you face any resistance from industry? 2) Also there are a number of populations involved in the risk to these pesticides, how aware are these population as you have large country? A: 1) We have one company with 80% majority of the pesticide market in the country. For the company it is beneficial to comply with us so as they benefit by overshadowing the smaller companies and illegal sellers. So, no there was no real objection from the industry. 2) We made sure we educated stakeholders on the risks, we provided training. Overview of country information relevant to the management of HHPs Ivy Saunyama – FAO SFS Pesticide Risk Reduction Officer & SAPReF Coordinator Harold van der Valk - FAO Consultant – Pest and Pesticide Management Consultant (FalConsult) Background Ahead of the workshop, a questionnaire on pesticide management, including implementation of the Rotterdam Convention was sent out to all the participants. Responses were received from all the 15 SADC countries. 1. Registration organization What is the organizational setup for pesticide registration in your country? a. Which legislation provides the legal framework for pesticide registration (name the key law(s) and/or regulation(s))? Of the 15 SADC countries 13 have legislation to regulate/register pesticides. b. For which different type of pesticides is registration required (agricultural, public health, domestic, etc.)? 13 countries regulate Agricultural pesticides; 11 countries regulate Public Health pesticides; 7 countries regulate Household pesticides; and 6 countries regulate Veterinary pesticides. c. Is it possible to ban/restrict the use of registered pesticides if they are already identified as a HHP? Answer: 13 out 15 countries have the provision. YES – Angola, Botswana, Malawi, Mauritius, Mozambique, Zambia, Zimbabwe, South Africa, Namibia (because registered products get renewed annually), Seychelles (but it has to go through Minister of Health), DRC (because registration has a validity of 2 years and during 16 renewing action can be taken), and Madagascar (allows the use after revision). For Tanzania some Regulations would be required. NO – Lesotho and Swaziland (as they do not have an Act in place). 2. Decision making criteria: Are criteria already used to refuse registration of a pesticide identical/similar to those used to identify HHPs? WHO class 1, Rotterdam and Stockholm conventions, registration in country of origin, >4 hazard pictograms. 3. Hazard Classification: What system of hazard classification of pesticides is being used in the country? (e.g., WHO Classification of pesticides by hazard, GHS, national system (specify classification criteria). 9 countries use the WHO classification system, 2 use GHS, 2 use a combination of WHO and GHS, whilst 2 countries use their own national classification system. 4. Pesticide import/production: Which registered HHPs are imported/used in the country? 9 countries have no import data and only 3 have data. 5. Incident reports/studies: Reported incidents with pesticides causing effects on human health (farmers, vendors etc.) or the environment, over the last 5 years. 3 countries appear to compile incident/poisoning data 3 regulators receive reports but not systematically 6. Pesticide use studies/surveys: Can we evaluate exposure to HHPs from local pesticide use practices? 5 countries have conducted studies on pesticide use practices The other countries did not report such surveys 7. Rotterdam Convention: Concrete actions, since the workshop in June 2015, to implement the Rotterdam Convention? 2 Countries are not yet a party to the convention; and 9 countries have not reported any actions 17 Understanding Hazards vs. Risks H-Andrea Rother - UCT Environmental Health Division All pesticides have a hazard but they each pose a different level of risk. The difference between Hazards and Risks? Hazards: are anything that may cause harm Risk: is the chance that the hazard may cause harm. Pesticide Hazard & Risk Hazards: mostly based on acute toxicity from WHO hazard classification; laboratory data Chronic effects are not reflected on the labelling. WHO hazard classification looks only at acute toxicity–. GHS looks at both acute and chronic toxicity. It is important to look at how the data is extrapolated. Data from research with animals and extrapolated to humans the most usual animals are mice. Risks: Are context specific such as climate conditions, the health status of applicators/workers, and in some situations culture (when not being allowed to wear trousers/pants and so can be more exposed to pesticides). Risk vs Hazard Assessment Hazards assessment: The process of identifying the inherent dangers/toxicity of the product Risk assessment: The identification and comparison of exposures to hazards and the putting in place of control/risk reduction measures. Pesticide Risks/Exposure Implications Short and long term health effects (acute & chronic) Health status of workers’ or the public (malnourished, TB infected, HIV positive) Exposure to multiple pesticides at work and/or home) The Ways Pesticides Enter the Body 1) Through the skin (dermal); 2) Through the mouth (oral/ingestion); 3) Through the lungs (respiratory); and 4) Through the eyes (ocular) Issues influencing the effect of the pesticide exposure are: 1) Routes of exposure, 2) Concentration and type of pesticide exposed to, 3) Duration of exposure, 4) Frequency of exposure, and 5) Exposure scenario’s. and these need to be considered during assessments of hazards. 18 Examples of Pesticide of Concerns Glyphosate, malathion, diazinon (Category 2A) - Extensively used. A list of health effects associated with glyphosate are listed within Table 1. Table 1. 15 Health Effects research has linked to glyphosate Attention Deficit Disorder (ADHA) Alzheimer’s Disease Anencephaly (birth defect) Autism Birth defects (hypospadias, heart defects) Brain cancer in children Breast cancer Cancer Celiac disease & gluten intolerance Chronic kidney diseases Colitis Depression Diabetes Heart disease Hypothyroidism Inflammatory Bowel Disease Liver disease Lou Gehrig’s Disease (ALS) Multiple Sclerosis (MS) Non-Hodgkin lymphoma Parkinson’s disease Pregnancy problems (infertility, miscarriages, still births) Obesity Reproductive problems Respiratory illnesses (chronic) Multiple Pesticide Use in Context When talking about pesticides you need to be specific on the context. What exactly they are being used for, i.e. eradication of mosquitos, rodent infestation elimination. A more inclusive list of the most common uses of pesticides is detailed within Table 2. Table 2. Common Uses of Pesticides Agriculture Crops; horticulture; weed control; chicken feed fly control Borders Mosquito control on airplanes, phyto-sanitary & foot/mouth disease control Domestic Home & garden use; lice shampoo; paints, hand wash Forestry Treated timber; alien invasive vegetation removal Leisure areas Hotels, golf courses Laboratories Research; export residue testing Public Health Malaria; community pest control Public spaces Schools, hospitals, office buildings, public buildings (supermarkets, restaurants) landfills; weed control on pavements Transport Land & sea movement of pesticides; treated boat hulls Veterinary purposes Livestock; domestic pets; foot & mouth disease Unregistered uses Street pesticides; self-harm; problem animals; homicides; warfin in street drugs Migratory Pest Control Quelea birds; locusts Rother, H-A SAMJ (2012) 19 The low risk beliefs reflected in high exposure risk behaviours Using pesticides with no, limited or incorrect PPE (increasing absorption) Reusing containers for food & water storage; decanting into common drink bottles Re-entry too soon in sprayed area (e.g., IRS) Exposed when health status low (immune compromised; malnourished; allergies) Pesticide Culture increasing exposures: The existence of a “culture of pesticide use” in SA (Rother 2008) Pesticide Risk Reduction Approaches: Hierarchy of Control (HOC) [Diagram below] Controlling exposures to occupational hazards is the fundamental method of protecting workers. Two representations of this hierarchy are as follows: Diagram 1. Hierarchy of Control The National Institute for Occupational Safety and Health (NIOSH) (2015) Hierarchy of controls: Overview. Centers for Disease Control and Prevention (CDC). Available at: http://www.cdc.gov/niosh/topics/hierarchy/ Quality Systems Toolbox () Hierarchy of Controls. Quality Systems. Available at: http://www.qualitysystems.com/support/pages/hierarchyof-controls Conclusion: 1) you need to understand which HHP criteria is for risk and which for hazard, 2) identify exposure risks in your country through many sources, and 3) Use 8 criteria to identify risk Question and Answer Section Q: Where did the HOC originate from? Was it created for pesticide usage? A: The HOC was created for use in occupational health, to identify and mitigate against occupational hazard, thus it can be used with regards to pesticide usage. With all pesticides especially HHPs the most effective method of mitigation is the elimination of the pesticide (hazard). If that is not possible or feasible due to the need of the pesticide, it is preferable to look for a substitute that is less harmful and can replace the hazard. However, in most low resources countries we focus on 20 administrative control (behaviour) and the use of PPE to protect the workers using pesticides, but these measure are difficult to control as they are dependent on the actions of the workers. So with continued referral to the HOC regulators can find the best ways for hazard control. Identification of HHPs: The criteria Harold van der Valk - FAO Consultant – Pest and Pesticide Management Consultant (FalConsult) In the International Code of Conduct (2013) HHPs are acknowledged as pesticides that “present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as the World Health Organization (WHO) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or their listing in relevant binding international agreements or conventions. In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.” HHP criteria Present criteria identifying HHPs were defined in 2008 FAO/WHO Joint Meeting on Pesticide Management (JMPM) Pesticides are classified as HHPs when: 1. Pesticide formulations that meet the criteria of Classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard; or 2. Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS); or 3. Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the GHS; or 4. Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the GHS; or 5. Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention; or 21 6. Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III; or • Pesticides listed under the Montreal Protocol; or • Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment. Criteria 1 : WHO class Ia & Ib Data sources: LD50 values Criteria 2, 3 & 4: GHS Category 1A & 1B for “CMR” • GHS Part 3 = Health Hazards • GHS developed for all chemicals; not just pesticides. • GHS increasingly required for labelling of chemicals in international (and national) trade. Criteria 5: Stockholm Convention Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of annex D of the Convention Annex A: Chemicals to be eliminated (Data sources: Stockholm Convention web site) Annex B: Chemicals to be restricted (Data sources: Stockholm Convention web site) Annex D: Screening criteria for POPs (Data sources: Pesticide registration dossier & Reputable pesticide property databases) Criteria 6: Rotterdam Convention Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III (Chemicals subject to the prior informed consent procedure) Criteria 7: Montreal Protocol Pesticides listed under the Montreal Protocol (methyl-bromide) Data source: UNEP Ozone Secretariat web site Criteria 8: High incidence of adverse effects Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment. • At discretion of national regulatory authorities HHP identification: Would be of great benefit to all countries, the environment and populations for different countries to have the same HHP identification. Harmonisation and working together would bring the best results. 22 There are other HHP identification criteria CropLife International = FAO/WHO criteria minus: Annex D of the Stockholm Convention + Annex III of the Rotterdam Convention + High incidence of adverse effects, due to non-recommended uses Pesticide Action Network International = FAO/WHO criteria plus: GHS acute inhalation Category 1 & 2 + Potential endocrine disruptor + 2 out of 3 of: very persistent, very bio-accumulative, very toxic to aquatic organisms + Highly toxic to bees (US-EPA) FAO & WHO recommend the present Guidelines on Highly Hazardous Pesticides (2016) Using the Pesticide Registration Toolkit to enable identification of HHPs Harold van der Valk - FAO Consultant – Pest and Pesticide Management Consultant (FalConsult) Toolkit home page: http://www.fao.org/pesticide-registration-toolkit Toolkit application page: http://www.fao.org/pesticide-registration-toolkit/tool/home/ In developing countries pesticide registration authorities tend to have extremely limited resources such as: Personnel (time), Specific expertise, Finances and Access to external information/specialists. Reinventing the wheel (in particular if it has been well invented) is a waste of resources. Thus if a chemical/pesticide has been evaluated in resource-rich countries it is of benefit to SADC countries to use that information as a guide. History of the Toolkit Development of the Toolkit started in early 2014 • FAO HQ coordinating unit • Working groups of topic experts – Advice on contents of specific modules – So far: Residues, Occupational risk assessment, Registration by analogy, Pollinators & beneficials, Efficacy, Surface- & groundwater risk assessment • Toolkit developers – FalConsult, Envista Consultancy, FAO IT Division • Peer review (ad hoc) by registrars and experts 23 Objective of the Toolkit • Make existing information relevant for pesticide registrars available “at fingertips” • Provide guidance about key registration procedures and methods in an interactive manner • Assist registrars in informed decision making • Create a basis for training and capacity building of pesticide registration authorities Pesticide Registration Toolkit What is the Toolkit (and what not) • Decision support system for pesticide registrars in developing countries • Web-based registration handbook intended for day-to-day use by those involved in the registration of pesticides • Not an automated system for the evaluation of pesticides. But it supports and facilitates informed decision-making by registrars • Focussed Registration Tools [not pesticide-specific] Processes and procedures (underlined are Toolkit modules of particular interest for HHP risk reduction) • Get advice on what registration strategy to follow • Get advice on steps in the registration process • Assess data requirements and testing guidelines for the evaluation of a specific type of pesticide for a particular use. • Access evaluation methods for the various aspects of the pesticide registration dossier • Get advice on risk mitigation measures • Get advice on decision making principles and procedures Links to Information Sources [pesticide-specific] (underlined are Toolkit modules of particular interest for HHP risk reduction) • Existing registrations through national databases/lists • Restrictions and bans by international conventions • Scientific reviews by reputable international and national bodies • Hazard classifications and labels • Pesticide properties databases with information on individual pesticides • Maximum residue limits (MRLs) • Pesticide specifications 24 End of Day 1 Key Summary Reporting team It is important to consider pesticide externalities when weighing the price of pesticides. ‘The price of a pesticide does not necessarily reflect the cost a pesticide.’ It is a myth that “alternatives are really more expensive than HHPs….” Lack of or outdated legislation has led FAO and other development partners to offer technical and financial support for the development and update of pesticide legislation so that it covers sound life cycle management of pesticides. Sound pesticide legislation forms the cornerstone of any risk reduction measures for HHPs. There is currently a window of opportunity to obtain funding of up to USD500,000 for capacity building and strengthening chemical management (including HHPs) from UNEP/SAICM. FAO would be willing to support HHP risk reduction work, especially for a regional HHP risk reduction strategy. To safeguard the strides Mozambique has made on HHPs, and any other national efforts, neighbouring countries should collaborate and as far as possible take a regional approach to reduce HHP risks (e.g. aldicarb & methamidophos being smuggled into Mozambique from neighbouring countries). Aldicarb – a nematicide that is widely used as a rodenticide across Southern Africa – one HHP that requires a regional approach due to the rampant illegal importations and uses. “We need a regional agreement on HHPs and beyond national HHP risk reduction plans, may even go as far as having a common regional pesticide list.” The background information submitted by all 15 SADC countries indicates there are preconditions relevant for HHP risk reduction, especially if information is shared and we work together. There needs to be awareness raising to stimulate and encourage adoption of safer and sustainable practices/alternatives foe HHPs. There is optimism that even pesticide marketers will adjust to the demand for safer alternatives. Mozambique reported on good cooperation from industry; stakeholder consultations are of key importance. Criterion 8: While complicated, it is very important to understand local conditions of use and also give regulators some liberty of assessing risks under local use context….e.g. Certain WHO Class II pesticides can locally be HHPs. There need to constantly reference to the ‘hierarchy of control’ as we work on HHP risk reduction strategies. Recommended criteria for identifying HHPs – FAO/WHO HHP Guidelines. Mauritius is an example of a country that has taken several successful measures on pesticide risk reduction. 25 DAY 2 – APRIL 26TH 2016: IDENTIFICATION OF HHPS Review of Individual Pesticides and Discussion on Methodology Harmonized methodology for identification of HHPs in SAPReF? Lilian Törnqvist - KemI Since early 1990’s, active substances have been evaluated at European Union (EU) level. Within the EU decisions on the approval and non-approval (ban) of active substance are done at EU level. About 900 active substances were originally on the market; however around 640 of those evaluations did not have the support from industry or incomplete dossier. Approval process includes: 1) The risk assessment has shown that a representative product can be used with ”acceptable risk” to human health and the environment, 2) Approvals might include extensive risk mitigation measures, and 3) Possibility to approve active substances without a full risk assessment due to lack of data, if likely that the risk assessment would show ”acceptable risk”. About 500 (currently 478) active substances have been approved within the EU. The active substances include chemical substances, micro-organisms and viruses. Non-approval process includes: 1) “Unacceptable risk” to human health and/or the environment, and 2) Withdrawal of the substance from the review process involves the Knowledge of “unacceptable risks” and identification of large data gaps 67% of PPPs have been removed from the market in the EU as of 2009, with 26% approved and 7% not approved after review. The review process has been made easier in the EU due to harmonisation of regulation and due to work sharing. For resource limited areas work sharing could help relieve the pressures in regulation. 26 End of Day 2 Key Summary Reporting team An incident occurred in Pakistan where 23 people died from HHP, exemplifying the need for HHP identification and restriction. HHP identification requires the review/classification of individual HHP using different sources such as: o Pesticide Property DataBase (PPDB) o European Union endpoint o US-EPA Ecotox database o eChemPortal To populate a spreadsheet: Determination of whether the pesticide is HHP or not the following can be used: o Dossier toxicity data o Database toxicity data o Carcinogenicity o Mutagenicity o Reproductive toxicant o Listing in the Stockholm Convention (Persistency in water, soil, sediment – Annex D) o Listing in the Rotterdam Convention o Listing in the Montreal Protocol o High incident of adverse effects (Local area incidents) The European Union (EU) has been evaluating pesticides since 1990. EU substance registration process involves stakeholder departments being involved in the decision making, with the European Commission determining the decision. The approval duration is 10 years – Member state authorisation. There are guidance documents on how to access information from the EU registration process (What is needed in order to register a pesticide in the EU and the processes one has to go through). Practical Exercise on mapping the exposures to HHP where different scenarios were used: 1) Large scale farming, 2) Retail, 3) Airport, 4) Quelea, 5) Small Scale Farming, and 6) Informal market. 27 DAY 3 – APRIL 27TH 2016: HHP USE SURVEY & RISK ASSESSMENT METHODS HHP Use Surveys HHP use survey – objectives and methods Ivy Saunyama – FAO SFS Pesticide Risk Reduction Officer & SAPReF Coordinator It is vital for use to keep in mind the definition of what HHPs are. The impacts they may have on the environment and on the population at large. This will aid in the designing of process to address HHPs. There are three basic steps to the design process. The objective of the session was to introduce the participants to some of the tools being used in countries in Southern Africa (already used in Mozambique and adapted for current use in Botswana). 3 steps in designing a process to address HHPs Step 1: Identification (of HHPs in use) o Using the WHO/FAO JMPM Criteria (with Criteria 1-7 having reference lists & related guidance that can be found on the internet…detail in Annex 1 and Annex 2 – the FAO Pesticide Registration Toolkit) o As Criterion 8 is more complex & depends on the actual situation in individual countries there are a few indicators that could be considered such as: 1) Surveillance indicates relatively high incidences of poisoning or environmental impact; and 2) Surveillance indicates relatively high incidences of poisoning or environmental impact, .e.g. PPE is not available, products being grossly used in manners for which they are not approved. In such cases, targeted surveys should be conducted to establish whether the use of a product qualifies under Criterion 8 Step 2: Assessment This step involves the assessment of the risks that the identified products are posing to human health and the environment under the local conditions of use and to review the needs for these products, taking into consideration available alternatives = Risk Assessment. The countries already in the process of addressing HHPs are Mozambique and Botswana. Mozambique followed the sequence in order and Botswana is performing the HHP survey in parallel with Step 1. Risk Assessment – Exposure context Pesticide exposure may be increased by local circumstances such as: the availability of prescribed PPE, the availability of appropriate application equipment, poor 28 storage pesticides, limited ability to maintain and safely clean and store application equipment, and inadequate knowledge on pesticide use and risks they cause. The needs assessment serves to establish to what extent the product is actually needed for its current uses, what specific benefits it provides and whether effective, less hazardous alternative pest management approaches or products that pose less risk might be available. A needs assessment involve the following: 1) Stock-taking of the uses of identified HHPs and the reasons why they are being used, 2) Identification of possible alternatives that are effective and pose less risk, and might substitute for HHPs, and 3) Review of the need for identified uses of HHPs taking into consideration the available alternatives and economic aspects. This information can be gained from surveys. Botswana is currently conducting a combined HHP and Knowledge, Attitudes and Practices (KAP) survey. The objective of the survey is to develop a communication strategy to raise awareness n pesticide hazards, risks and even safer alternatives key to HHP risk reduction and generating data for HHP criterion 8, risk assessment under local conditions of use, needs assessment. The questionnaire being used has been adapted from the one developed for HHP work in Mozambique. The questionnaire being used in Botswana has been specifically designed to capture data for the KAP study as well as for Criterion 8. Data collection methods - Surveys using questionnaires, focus group discussions and in-depth interviews and/or key informant interviews Step 3: Mitigation Identifying measures to reduce the risks of HHPs, including alternatives (pesticide and non-pesticide), phase-out, or continued use with (severe) restrictions. The Botswana survey questionnaire was reviewed and discussed by the participants and a list of their suggestions/comments and responses are below in Table 1. 29 Table 1. Suggestions/Comments for Sections of the Questionnaire Suggestions/Comments Response Section A: Farmer Background Is religion important in the Yes, it will help with developing communication strategies and questionnaire? may also help us understand certain attitudes and practices regarding pest and pesticide use in the local context. You have missing information We will add it to the questionnaire as it is only in the consent such as contact details on the form. However the information on the questionnaire will be consent form coded to limit confidential information getting into the wrong hands Can we translate it the Yes, you can as long as you do not change the meaning. In questionnaire to our local Mozambique the people in the field wrote the questions in the language? local language. In the Seychelles, for similar work they translate the whole questionnaire into the local language ahead of the surveys to avoid the administering of different versions of the questions by the enumerators. Is there any further way to It depends on the enumerator. A more experienced enumerator compress the background will know how to complete some background questions. A lot of information so as not tire the the background information will provide information for later farmer? communications strategies. How do you qualify who is the It would be best to enquire from the first person you meet what right person to be asked the their role on the farm or property is before you go on an ask questionnaire too, as you may them the more complicated and detailed questions. spend a lot of time asking a person who will then tell you they don’t know anything about Section E – Pesticide Products This section has to be very country specific. You will need to adjust questions according to your context. We have asked the enumerators to take photos of the labels in order to assist with populating the table and also to have a collection of the different labels. As an enumerator it is a struggle to ask about people’s ages and other personal details. Is there a reason we have to ask these details as they do not want to tell us? Section G – KAP Additional G01 and G03 We ask the information so that we know how to get back to the people we interview and to draw conclusions for the studies; the background information is useful for interpretation of the information collected. This is country specific as you have different people responsible for pesticide control When you say applicator in the This is country specific. The applicator refers to people hired answer series, who do you refer specifically for applying pesticides. to? There seem to be numerous overlapping questions i.e. G20 says the same as C25; and G12 and G3 Section H – Future Intervention This section is very specific to the communication strategy. There is a need to harmonise Section’s C and H. 30 Methods of Risk Assessment Risk assessment – options and methods for human health and environmental risk assessment Harold van der Valk - FAO Consultant – Pest and Pesticide Management Consultant (FalConsult) The definition of hazard and risk are revisited using the Code of Conduct (2014) definitions. Hazard – the inherent property of a substance, agent or situation having the potential to cause undesirable consequences (e.g. properties that can cause adverse effects or damage to health, the environment or property). Risk – the probability and severity of an adverse health or environmental effect occurring as a function of a hazard and the likelihood and the extent of exposure to a pesticide. Methods of Evaluating Adverse Effects on Human Health and the Environment The adverse effects of chemicals including pesticides on human health and the environment can be evaluated on the basis of the hazard or the risk. This is when hazard assessments and risk assessments are performed. Hazard assessments are based on intrinsic properties of the pesticide, irrespective of exposure (dose) rate (e.g. LD50, ADI, DT50-soil) Hazard Assessments are easier, faster, less data need but they are less precise and often overprotective Risk assessments are based both on the properties of the pesticide and on the level and probability of exposure (e.g. risk quotient, toxicity-exposure ratio) Risk Assessments are more precise providing better risk estimate under local use conditions. However they require more data especially exposure. They are also more complex requiring more human resources. This is why most countries perform hazard assessment and not risk assessment. Although both assessments can be used, the risk assessment is the preferred approach in pesticide registration (“the dose makes the poison”) – however, hazard assessment is used for some aspects. 31 Levels of Risk Assessment There are different levels to the risk assessment: 1) Hazard assessment, 2) Qualitative risk assessment, 3) Bridging and existing risk assessment (semi-qualitative), and 4) Full local risk assessment (quantitative). The amount of data, time, resources and complexity required as you move from 1 to 4 increase but means the method is more precise. Hazard assessments involve the following principles: 1) Toxicity evaluation, 2) Hazard classification, 3) Circumstances in which a hazard may be expressed, and 4) Potential hazard concerns The outcome from performing a hazard assessment should the identification of the extent to which the pesticide is a hazard and through which methods of exposure. Decision-Making: Through the use of a hazard assessment alone, countries may: 1) Refuse registration of the pesticide if it clearly hazardous, 2) Register the pesticide with or without mitigation measure if the pesticide is deemed to a very low hazard and is likely acceptable for use, and 3) Conduct a risk assessment if it is not clear if the pesticide is acceptable for use. 1. Qualitative risk assessment Principle: 1) Outcome of the hazard assessment, and 2) Qualitative description of exposure (i.e. knowledge of local practices, hazard/risk mapping, use surveys, etc.) Example of a qualitative risk assessment: Pesticide X poses a high hazard to human health through occupational, bystander/residential and dietary exposure Pesticide applicators do not wear PPE: occupational exposure to pesticide X is therefore high Occupational risk of pesticide X is likely to be high Decision-Making: Through the use of a qualitative risk assessment alone, countries may: 1) Refuse registration of the pesticide if it likely to pose a high risk, 2) Register the pesticide with or without mitigation measure if the pesticide is likely to pose low risk, and 3) Conduct a risk assessment if it is not clear if the pesticide is acceptable for use. 2. Bridging and existing risk assessment (semi-qualitative) Principle: An existing risk assessment conducted in another (reference) country is bridged (“extrapolated”) to the situation under review in your own country/region. 32 There is no need to reinvent the wheel if a “reputable and well-resourced regulatory authorities evaluate the risk of pesticides”. We need to think of “How can one make use of these evaluations, when having to evaluate the risk of a pesticide for a local situation?” 3. Full local risk assessment (quantitative operator risk assessment) Predicted exposure: Few, if any, product-specific operator exposure studies will be available at registration ➔ rarely any measured exposure data Predictive exposure models are used instead Exposure models are using databases containing the results from operator exposure studies conducted in the field, with different types of equipment and methods of application. There are various different ‘Operator Exposure Models’ already in use around the world. These models may differ due to exposure scenarios, protection factors by personal protective equipment (PPE), lack of PPE, dermal absorption and body weight default values and exposure estimates from the underlying database. Below are examples of the different models available: Europe: a) EFSA Calculator, b) Agricultural Operator Exposure Model (AOEM), c) German model, d) UK Predictive Exposure Model (POEM), and e) Southern Greenhouse model. North America: a) Occupational Pesticide Handler Unit Exposure Surrogate Reference Table (PHED, AHETF, …) Pesticide industry (CropLife International): a) CropLife OpEx Tool, (includes theUSEPA Occupational Pesticide Handler Surrogate Reference Table and theGerman model) Organisations: WHO Pesticide Evaluation Scheme – Generic Risk Assessment Models (Exposure models for public health pesticides (disease vector control) 33 End of Day 3 Key Summary Reporting team The FAO criteria for identifying HHP’s were revisited, with a focus on 8th criterion (Conditions for Local Use). It is difficult to really reach a decision based on obvious evidence, however there is a need to: 1) get a grip on health surveillance information though not conclusive; 2) get in the mood of picking also the academic information from learning institutions; and 3) get used to using survey tools in the way Mozambique and Botswana are. Mozambique used risk assessments and Botswana are beginning to use them in combination with HHP identification with KAP. From Mozambique it was learnt that: o There is a need for active involvement of stakeholders o Information on field use is required when evaluating risks o Poisoning and Health surveys should be carried out in rural area too o Survey methodologies, questionnaires or focus groups HHP use survey group work; to get a feel at the work and agree on a regional minimum data requirement for needs assessment. We needed to make sure that enumerators are trained well and understand the importance & the task before them, enumerators need to be backed up and supported continuously, that their intelligence can also be depended upon to also make observations that answer some questions without necessarily pronouncing the questions. Hazard assessment; easy to do but less precise and tends to be over protective Risk assessment; more precise, better risk estimation under local conditions of use for pesticides, however might be complex and requires more human resources than we can generate as individual countries. There is a need to bring together the two assessments (risk and hazard) and appreciate the pros and cons of doing either one of the assessments. There are different stages to risk assessments: o Hazard assessment: toxicity evaluation on the basis of the dossier o Qualitative risk assessment: gives a more comprehensive and logical reasoning for us to make decisions o Bridging assessment: extrapolation of data from other usually trusted sources for comparison o Full local risk assessment: includes quantitative and qualitative assessments of information based on local conditions The FAO toolkit can be used to facilitate risk assessments. 34 DAY 4 – APRIL 28TH 2016: RISK MITIGATION Risk mitigation: options and constrains: Assessment of (non-chemical) alternatives Risk mitigation – options and constraints Harold van der Valk - FAO Consultant – Pest and Pesticide Management Consultant (FalConsult) Mitigation in risk management is performed in order to ensure that the risk of the (highly hazardous) pesticide is acceptable for local conditions of use By referring back to the HOC there is the opportunity for identifying options for risk mitigation of HHPs End use (and substitute: lower risk pesticide or non-pesticide alternative) Change formulation or packaging Restrict use (users, crops, locations, etc.) Impose engineering controls (deflectors, closed cabins, etc.) Change use practices (training, awareness) Increase PPE requirements The Pre-conditions for effective mitigation measures are that they: 1) should have been demonstrated, or is likely, to be effective under local conditions, 2) should be feasible for the pesticide user (e.g. the farmer), and preferably not compromise pesticide product efficacy, 3) should be affordable for the pesticide user, 4) the expected reduction of risk should outweigh the cost of the measure, 5) should be possible to communicate the measure to the user in an relatively easy and effective manner (e.g. though the label or the extension services), 6) should have a reasonable possibility of enforcement, and finally 7) should be possible to make a quantitative estimate of the efficacy of the measure so that its effect can be incorporated into the risk assessment. Examples of Measures limiting human exposure Require specific personal protective equipment o Questions to ask: Effective? Available? Affordable? Realistic? Increase pre-harvest intervals, to protect agricultural workers o Realistic for pest control & harvest time? Examples of Measures limiting environmental exposure Apply a no-spray or no-crop buffer zone between the treated area and the off-crop area o Questions to ask: Field size? Yield loss? Enforceable? 35 Do not apply during crop flowering, to protect pollinators o Questions to ask: But what if the pest attacks the flowers? Whenever a risk mitigation measure is required or recommended as part of registration, it should be assessed whether this measure can be realistically implemented under the proposed conditions of use. This is the responsibility of the registration authority. In the Pesticide Registration Toolkit, there is currently a Feasibility check tool in the development stag. The objective of the tool is to list several measures and procedures for mitigating of human health risks and environmental risks. As part of this tool there is an Inventory of risk mitigation measures (in development), that aims to assist in limiting human health risks and limiting environmental risks. For each measure within the inventory there are: 1) a summary description, 2) estimated risk reduction potential, 3) possible negative effects of the measure, and 4) Pre-conditions for effective implementation. Assessment of alternatives – options and constraints Ivy Saunyama – FAO SFS Pesticide Risk Reduction Consultant & SAPReF Coordinator The approach to pesticide risk reduction as described in the FAO Guidelines on Pest and Pesticide Management Policy Development [2010] comprises three main steps: 1. Reduce reliance on pesticides: Determine to what extent current levels of pesticide use are actually needed and eliminate unjustified pesticide use. Make optimum use of nonchemical pest management practices in the context of sustainable intensification of crop production and integrated vector management. 2. Select pesticides with the lowest risk: If use of pesticides is deemed necessary, select products with the lowest risk to human health and the environment from the available registered products of those that are effective against the pest (insect, disease, weeds etc.). 3. Ensure proper use of the selected products: Ensure proper use of the selected products for approved applications and in compliance with national regulations and international standards. A needs assessment involves the following: Stock-taking of the uses of identified HHPs and the reasons why they are being used. Identification of possible alternatives that are effective and pose less risk, and might substitute for HHPs. Review of the need for identified uses of HHPs taking into consideration the available alternatives and economic aspects. 36 Availability of Alternatives Myth: HHPs need to remain available because there would be no good alternatives Why this misconception? User habits or advice based on limited knowledge or by persons with interests in the pesticide products. FACT In the majority of cases, there are alternatives that pose less risk. These may include: • suitable bio-pesticides or non-chemical pest management approaches; • less hazardous chemicals; • different formulations that pose less risk. • IPM/IVM and other agro-ecologically based production systems Sustainable Crop Production Intensification Sustainable crop intensification involves “techniques that produce more output from the same area of land while reducing negative environmental impacts and enhancing natural capital and the flow of environmental services” FAO’s model of ecosystem based agriculture, Save and Grow presents a new paradigm of production that is highly productive and environmentally sustainable. Save and Grow incorporates CA, healthy soils, improved crop varieties, efficient use of water and IPM. The Code of Conduct defines IPM as the careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep pesticides and other interventions to levels that are economically justified and reduce or minimize risks to human and animal health and/or the environment. IPM emphasizes the growth of a healthy crop with the least possible disruption to agro-ecosystems and encourages natural pest control mechanisms. An ecosystem-based IPM approach to pest management uses inputs such as land, water, seed and fertilizer to complement the natural processes that support plant growth including pollination, natural predation for pest control, and the action of soil microorganisms that allow plants to access nutrients. NB. There needs to be a word of caution about some versions of IPM. Some definitions of IPM which promote calendar spraying, take no note of effects on natural enemies or agroecological approaches…e.g. promotion of use of Endosulfan has been promoted as part of IPM by the pesticide industry in China. 37 A needs assessment involves the following: • Stock-taking of the uses of identified HHPs and the reasons why they are being used. • Identification of possible alternatives that are effective and pose less risk, and might substitute for HHPs. • Review of the need for identified uses of HHPs taking into consideration the available alternatives and economic aspects. Approaches in Identification of Alternatives Look at crop protection methods in other countries with similar agro-ecological conditions that have banned use of particular HHPs – info. On availability and viability of such alternatives There may be exceptions for continued use of HHPs made where there are no good alternatives e.g. restricted use BUT the exceptions should be temporary whilst alternatives are being identified. Economic Aspects The economic aspects to be considered with respect to alternative are the: 1) effects of pesticide residues on the value of the produce, 2) residues of HHPs likely to render produce unsuitable for consumption or export – income risk to farmers, 3) Consistent production following IPM may attract a premium on the price of the crop/produce, 4) Costs of HHPs tend to be under-estimated because of lack of information on health and environmental impacts, which may represent significant public costs while their benefits are over-estimated. Question and Answer Section Q: Are there Myths about Alternatives to HHPs? A: ‘Alternatives to HHPs are more expensive and farmers could not afford the alternatives and be deprived of affordable pest management options.’ A: Another Myth is below What to consider in order to understand the full costs of HHPs Directs costs: costs of pesticides, PPE, application equipment Indirect costs: health costs for the applicators, loss of labour time due to pesticide poisoning related illness; long term health effects; public costs incl. long term health costs to farming communities and consumers + environmental costs associated with water contamination and loss of biodiversity. 38 Regional coordination and collaboration for HHP risk reduction Harold van der Valk - FAO Consultant (FalConsult) o o o o o The key aspects of a regional HHP coordination and collaboration are: At very high political level of support – A SADC resolution on HHPs harmonized data sources for HHP criteria Regional HHP list common templates for the conditions of use survey research tools harmonized approaches to promotion of safer alternatives to HHPs (e.g. common IPM database for local adaptation; harmonized registration of biopesticides; regional database of poisoning incident reports Rotterdam Convention: Implementation Article 5 under information exchange Connecting it all with the Rotterdam Convention Nadia Correale – RC Secretariat Overview of the Rotterdam Convention Origins: Born from a need to protect countries lacking adequate infrastructures to manage hazardous chemicals in international trade. The Convention is to strengthen weak pesticide management which result in: Improper use of pesticides, inadequate storage and control, environmental damage, serious ill health, and the collection of obsolete stockpiles and expensive clean-up operations. It is important to link pesticide management to the 17 Sustainable Development Goals (SDGs) as these are the goals and targets globally for the next 15 years. Dangerous chemicals are mentioned in the SDGs numerous times in the key targets: 39 Goal 2: o 2.3: double the agriculture productivity and incomes of small scale farmers o 2.4: ensure sustainable food production Goal 3: o 3.9: sustainably reduce the number of deaths and illnesses from hazardous chemicals and air, water, pollution and contamination Goal 6: o 6.3: improve water quality by reducing pollution, eliminating dumping and minimizing release of hazardous chemicals and materials… o 6.5/6.6: water resources management, protect water-related ecosystems … involving local communities… Goal 8: o 8.5/8.8: decent work for all, women and men, migrants and youth…, promote safe and secure working environment Goal 10: o 10.2/10.3: empower and promote the social, economic and political inclusion of all…, ensure equal opportunity including by eliminating laws, policies and practices and promoting legislation, policies… Goal 12: o 12.2: ensure sustainable management and efficient use of natural resources o 12.4: achieve environmental sound management of chemicals and wastes throughout their life cycle, in accordance with agreed international frameworks and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health and the environment Goal 14: o 14.1: prevent and significantly reduce marine pollution of all kinds… Goal 15: o 15.9: Integrate ecosystem and biodiversity values into national and local planning, development processes, poverty reduction strategies and accounts o 15.9: Integrate ecosystem and biodiversity values into national and local planning, development processes, poverty reduction strategies and accounts Goal 17: Capacity building 17.9: enhance international support for implementing effective and targeted capacity building in developing countries to support national plans to implement all SDGs … Objectives of the Rotterdam Convention Rotterdam Convention aims: To promote shared responsibility among Parties in the international trade of certain hazardous chemicals in order to protect human health and the environment from potential harm. The Convention contributes to the environmentally sound use of such chemicals: by facilitating information exchange about their characteristics by providing for a national decision-making process on their import and export by disseminating these decisions to Parties Hazardous Pesticides in the scope of RC BANNED PESTICIDES: Article 5 notification of nationally banned and severely restricted chemicals for human health and environment reasons based on a risk evaluation POTENTIAL UNWANTED PESTICIDES: Article 6 severely hazardous pesticides formulations (SHPF) causing adverse effects under local conditions of use Hazardous Pesticides-ANNEX III – subject to PIC procedure: 47 chemicals and DGDs available 40 Key Players: Designated National Authorities (DNAs), Conference of the Parties (COP), Chemical Review Committee (CRC), Secretariat How does RC operate at global level? Key Provisions: PIC procedure and Info exchange; and Chemicals in PIC Procedure PIC procedure: increases the transparency in the trade of hazardous chemical and reduces the vulnerability of abuse. 1) COPs lists a chemical in Annex III & approves a DGD; 2) DGD is circulated to facilitate parties making informed decision; 3) Parties submit import response for each chemical; 4) Secretariat circulates all import responses to all Parties through the PIC Circular; and 5) Exporting Party takes measures to comply with import decisions. Info exchange: enables member Governments to alert each other of potential dangers by the exchange of information on severely restricted and/or banned chemical 1) PIC circular; 2) Export notification; and 3) Information to accompany export Chemicals in PIC Procedure: 1) Final regulatory actions taken on a chemical by at least one country each, from two PIC Regions; and 2) Reviewed by CRC in accordance with Annex II The Overall Benefits of the Rotterdam Convention The main benefits of the RC are: Shared responsibilities – among exporting and importing Parties Early warning system - PIC Circular provides information Informed decision-making – DGD for each chemical. Export notification – reminds, informs Info accompanying export Technical assistance Implementing article 5 for Notifications of final regulatory action. Information exchange and PIC procedure Nadia Correale – RC Secretariat The RC is a legally binding international instrument that provides rights and benefits to Parties and at the same time creates obligations for them without which the Convention couldn’t function. Notifications of final regulatory action are the means by which Parties inform the Secretariat of their national actions the purpose of which is to ban or severely restrict a chemical for human health and/or environmental reasons. 41 Convention does not specify: how to regulate chemicals or how to make a regulatory decision → national decisions! Convention does require that final regulatory decisions to ban or severely restrict a chemical to protect human health or the environment be notified to the Secretariat Key Provisions under the Rotterdam Convention Article 2 – Definitions: Banned Chemical and Severely Restricted Chemical Article 2 defines a Banned Chemicals as: a chemical all use of which within one or more categories have been prohibited by final regulatory action, in order to protect human health or the environment. It includes a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the domestic market or from further consideration in the domestic approval process and where there is clear evidence that such action has been taken in order to protect human health or the environment Article 2 defines a Severely restricted chemical as: a chemical virtually all use of which within one or more categories have been prohibited by final regulatory action in order to protect human health or the environment, but for which certain specific uses remain allowed. It includes a chemical that has, for virtually all use, been refused for approval or been withdrawn by industry either from the domestic market or from further consideration in the domestic approval process, and where there is clear evidence that such action has been taken in order to protect human health or the environment. Article 5 - Procedures for banned or severely restricted chemicals: Responsibilities of Parties and Process followed Article 5 details the responsibility of Party States in the following ways: o For existing national regulatory actions in this regard the DNA is to notify the Secretariat when the Convention enters into force for that country o For new regulatory actions in which the DNA is to notify the Secretariat within 90 days o DNA completes a “notification of final regulatory action form” - the signed and dated form is submitted to the Secretariat - must contain the information set out in Annex I, where available • Annex I - Information Requirements for Notifications made pursuant to Article 5 The requirements in the Notification Process are as follows: 1) Parties are expected to takes a final regulatory action to ban or severely restrict a chemical, 2) DNA 42 completes a notification form and sends to the Secretariat, 3) Secretariat verifies that the notification is complete e.g. meets the information requirements of Annex I and requests supporting documentation, 4) Summary of the notification is published in the PIC Circular The benefits of the notification are that: Information exchange, alerts other parties of a potentially hazardous chemical (PIC Circular) - Summary of new notification published in Appendix I - List of complete notifications published in Annex V May lead to consideration by the CRC and a possible recommendation for listing in Annex III Notifying Party is to send Export Notifications for such chemicals Implementing article 6 for SHPF (Severely Hazardous Pesticide Formulations) proposal Nadia Correale – RC Secretariat This article is not an obligation for States but a great opportunity for developing countries and countries with economy in transition to propose the inclusion of a pesticide formulation in Annex III and to inform global community about their specific problems with pesticide formulation related to conditions of use. Under Article 2, the formulation for severely hazardous pesticides is defined as chemicals formulated for pesticide use that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use. Article 6 outlines the Procedures: Country experiences problems with a specific pesticide formulation under conditions of use in its territory. DNA submits a proposal to the Secretariat based on the data collected at field level. Secretariat verifies that the information requirements of Annex IV, part 1 have been met. o Summary is published in the PIC Circular (Appendix II) Secretariat collects additional information (Annex IV part 2) There are 5 Key Criteria that can be used: Criteria 1: Reliable evidence that common or recognised patterns of use within the Party led to the incidents (Reflects differing level of regulatory control of pesticides among countries, many common or recognized uses in developing countries do not appear on labels or in extension guides) 43 Criteria 2: Relevance to other States with similar conditions (climate, conditions and patterns of use) Criteria 3: Existence of handling or applicator restrictions that may not be reasonably or widely applied in States lacking the necessary infrastructure (Link to Article 6 the ‘problems… under conditions of use ’, and identify similar formulations may be used in developed countries with requirement for extensive protective measures. In many developing countries such protective measures are not practical or are not available) Criteria 4: The significance of reported effects in relation to the quantity of the formulation used Criteria 5: Intentional misuse is not an adequate reason Within countries, action should be taken from the field level to national level in the following steps: 1) Collecting survey data on risky practices and common exposure routes, 2) Collaboration and involvement of the Designated National Authority (DNA) and key stakeholders, and 3) SHPF proposal based on the health/environmental incidents reported at field level can draw global attention on a problem with a specific pesticide formulation. Wider prospective action can begin at the national level with the goal of global awareness. Here Parties to the RC Convention identify Problems with a pesticide formulation under conditions of use to draw up proposals to be submitted to the Convention Secretariat. These proposals may be may draw upon technical expertise from any relevant source e.g. NGOs and incident report forms (environmental and human health) developed to facilitate preparation of a proposal. Examples of these actions are those from: 1) African Lusophone countries “Measuring Impact: from data collection to national decision process”, and 2) Georgia how from 2014-2015: Protecting farmers and vulnerable groups from pesticides poisoning and 2016: Supporting evidence-based pesticide regulation and risk reduction, with a focus on vulnerable groups It is vital to consider the Challenges States may face. These challenges are: Lack of legal/policy framework in support to the collection of data Poisoning incidents not well documented (hospitals, etc.) Anecdotal information on poisoning incidents exists DNA for Rotterdam Convention not communicating with the fields, farmers and ministries Limited knowledge of the process to submit proposals Not good familiarity with the forms 44 Addressing challenges identified by the countries and way forward Nadia Correale – RC Secretariat Notifications of final regulatory action are the means by which Parties inform the Secretariat of their national actions the purpose of which is to ban or severely restrict a chemical for human health and/or environmental reasons. There are numerous challenges to be considered during the notification process: • limited knowledge of the process of notifications • what is a risk evaluation under RC • no clear link to exposure under prevailing conditions for the notifying country • how to use bridging information • familiarity with the form • DNAs changing after training 45 End of Day 4 Key Summary Reporting team Conclusions acquired from – Hazard evaluation, Occupational Risk assessment models, occupational risk assessment for Lannate (Methomyl) – reflected more less similar outcome. Products to be rejected or restricted for use under conditions that it will be applied by tractor and not knap sack sprayer as recommended. *Emphasis on: (i) exposure exceeding 100% based on the measurements presented is harmful and (ii)Importance of Dossier evaluations during registration. Risk mitigation Risk Mitigations are: Measures of actions that should be taken to reduce the risk for human health or the environment. The measures to be taken are: 1) De registration, 2) Restriction, 3) Change formulation, 4) Change package, 5) Engineering control etc. Preconditions for effective risk mitigation: To be effective, Available, Affordable, Cost effective, To be supported by enforcement Measures that can limit human exposure – Increase Preharvest Interval (PHI), Promote Comfortable Personal Protective Equipment (PPE) Discussion – Issue of the need to have biological pesticides (as alternatives) Assessment of alternatives - Options and constraints Objectives – To emphasize the need for alternatives to the HHP which are to be removed from use (Non chemical) Provided Definition for IPM/IVM – According to International code of conduct (Article 2: Page 4) - Integrate different control options, Use interventions justifiable to human health/ environment Economic aspects on the use of alternatives: - Alternatives should cost effective – not too expensive for users, little or no residues on crop, promotion of export trade, safety to consumers etc. Misconception on IPM: Promotion of IPM as calendar spraying, Industry promoting Endosulfan as IPM product. Exercise: Group to identify possible alternatives for HHP in their respective countries (Non chemical) – To be presented today. Rotterdam Convention Emphasis: For protecting human health and environment, Legally binding, currently has 155 parties Objective: To promote shared responsibilities in chemical information to protect human health / environment Implementation of the Convention – Addressing some SDGS Key targets directly or indirectly – e.g. Sustain food production, Reduce death, Improve water quality, etc. 46 Key players: were mentioned – DNA, COP, Secretariat, CRC and each one has different responsibility. Benefit of convention: - Help to manage chemicals, Avoid unwanted chemicals, Raise awareness on bans, Facilitate export notification Opportunity: Technical support was declared to be available for developing countries in the implementation of the convention Severely hazardous pesticide formulations Countries are encouraged to submit SHPF proposal if they experience problem with a specific formulation that cause adverse effects on human health and environment. Country are encouraged to collect information based on data collected at field level. 47 DAY 5 – APRIL 29TH 2016: PLAN DEVELOPMENT Developing Action Plans and Regional Strategy National HHP Risk Reduction Plans This is vital to ensure active regulation of pesticides. Successful plans should include (for each step): • Activities such as the ‘Pesticide registration authority to reviewing all registered pesticides and identifying HHPs • Main actors (Pesticide registration authority) and other stakeholders (SAPReF: who can define sources to be used for HHP criteria; National Ministries/NGOs: who can provide incident reports) • Their tasks and responsibilities • Also indicate which activities (or part of activities) should best be conducted at the regional (SAPReF/SADC) level) • Time frames that are specific and realistic • Coordination mechanism(s) (where relevant) • Outreach and communication approaches such as Policy Briefs and Newsletters to informing Pesticide registration authority to review all registered pesticides and identify HHPs Regional HHP Risk Reduction Strategies When developing a regional plan it is vital to clearly indicate the activities to be carried out solely at National Level and those solely at Regional Level. The participants discussed a possible strategy for risk reduction of HHPs which identifies the roles of the various main actors, at national, regional and international level. This strategy is shown schematically in Figure 1. Three levels of intervention have been identified in the strategy: National: Main actor: pesticide regulatory authorities; other actors: relevant government ministries, private sector, NGOs, other stakeholders. Regional: main actors: SAPReF and the SADC Secretariat; other actors: other regional entities active in pesticide management International: Main actors: FAO, Rotterdam Convention, WHO, UCT. The following steps in the HHP risk reduction process are included in the strategy: 1. Build awareness & ensure buy-in The first step is building awareness among stakeholders involved in distributing and using HHPs, and ensuring the buy-in for tackling risk reduction by these stakeholders as well as by high-level policy makers. This is done through seminars and meetings at the national level. This activity is facilitated by a regional policy brief on HHPs to be elaborated by SAPReF. The SADC Secretariat, in 48 collaboration with SAPReF, should also draft a Resolution for adoption by SADC Members, on the importance of HHP risk reduction, with the aim to provide political backing for national activities. 2. Identify HHPs. The identification of HHPs is done at the national level, through a review of registered pesticides. However, the data sources that are to be used to assess whether a pesticide meets the HHP criteria need to harmonised regionally, by SAPReF, to ensure that the identification is done in a similar manner throughout the region. International organizations may provide technical assistance, where needed and requested. WHO is specifically asked to provide access to (pesticide) poisoning incident databases, to facilitate the identification of HHPs and subsequent risk assessment. After national identification of HHPs, SAPReF will compile the national lists in a regional database and make this available to the other Member Countries. 3. Take stock of use National pesticide regulatory authorities review the import and production statistics of identified HHPs. Whenever possible, pesticide (HHP) use surveys will also be conducted to get a good insight in the national use conditions of pesticides in general and HHPs in particular. SAPReF will develop a regional template for the use surveys, to facilitate the work of the national institutions, based on previous experiences in Botswana and Mozambique. 4. Assess needs At the national level, alternatives to HHPs will be identified, among others through a national inventory of effective IPM and IVM methods. International organizations will provide technical support where needed and requested, including capacity building on IPM and IVM. National inventories of IPM and IVM methods, and other alternatives for HHPs, will be compiled by SAPReF and made available to the other Member Countries, to facilitate national HHP risk reduction planning. Furthermore, SAPReF, in collaboration with the SADC Secretariat, will develop harmonized guidance on the registration of biopesticides (and possibly other biological control agents), to facilitate registration of alternatives to HHPs. 5. Evaluate risks For selected HHPs (e.g. products that continue to be required, but for which alternatives are not readily available), national regulatory authorities will conduct locally-specific risk assessments. 49 To facilitate this process, SAPReF will commission a regional review, to be conducted by UCT, of national pesticide incident reports and studies, and make it available to all Member Countries. International organizations may provide technical support, where needed. 6. Select mitigation measures Based on the outcome of the steps above, national pesticide regulatory authorities will select locally feasible risk mitigation measures for the identified HHPs that are in use in the country. The SADC Resolution adopted under Step 1 will provide political support for regulatory authorities to be able to propose and enforce such mitigation measures. 7 & 8. Due to time constraints during the workshop, steps 7 and 8 could not be discussed in much detail. They will need to be worked out at a later stage. It is noted that the steps in the strategy logically follow onto each other. However, several of the steps can be initiated simultaneously, and the lack of a full completion of one step does not necessarily mean that the next step cannot be started (e.g. steps 1, 2 & 3; and steps 4 & 5 may be conducted, at least in part, simultaneously, to gain time). 50 Figure 1. Strategy for HHP risk reduction in SADC member countries Source: van der Valk, Harold (2016) 51 FAO – Africa Solidarity Trust Fund Project Joyce MulilaMitti & Ronia Tanyongana - FAO SFS The Project is funded by the Africa Solidarity Trust Fund (ASTF) and is managed by FAO in partnership with SADC. It began in 2014 and will conclude in 2017. There are eight SADC countries currently implementing the project. These countries are: Angola, Botswana, Namibia, Madagascar, Mozambique, South Africa, Zambia and Zimbabwe. The overall goal of the Africa Solidarity Trust Fund Project is to “Strengthening controls of food safety threats, plant and animal pests and diseases for agricultural productivity and trade in Southern Africa.” ASTF aims to contribute to increased agricultural productivity and facilitate regional and international trade for improved food and nutrition security in the SADC region; and to ensure full compliance of the agreed international norms of the Sanitary and Phytosanitary (SPS) measures. The project focuses on Food Safety, Plant health, Animal Health, Forestry and Fisheries, supporting activities aligned to the new strategic and priority programmes of FAO, and funds Africa-led and/or owned initiatives in the framework of the African Unions CAADP. The activities that the ASTF is involved are varied and include but are not limited to: Plant Health and Forestry: Promotion of IPM approaches in all pest and disease management programmes, Baseline studies to assess gaps, constraints and needs at regional and country level and Regional Capacity Building activities cascading down to national capacity building activities at different levels up to value chain operators Animal Health: Implement a regional training for trainers on animal health Good Emergency Management Practices (GEMP) and develop an integrated (animal health/food safety) risk analysis framework and regional guidelines for commodity based trade (CBT) in deboned beef Fisheries: Provide technical support and build capacity for implementing bio-toxin and hazardous chemical monitoring techniques on bivalve harvesting area Food Safety: Creation of awareness on food safety issues including pesticide exposure risks and support to enactment and ratification of national and international policies and regulations for National Food Safety Management Opportunities for Collaboration 1. Regional Workshops Support to participants 2. Collaboration on activities that have a common objective e. g. Activities that promote Integrated Pest Management 52 3. Support to countries that are processing ratification for international conventions that address pesticide risk reduction management 4. Recommendation for priorities and estimated budgets of activities 5. Coordination at National level and creation of linkages with the project national coordinators SADC Regional Guidelines for the Regulation of Crop Protection Products in SADC Countries (2011) – Need for review? Starting points - We need to change the name from “Regional Guidelines for the Regulation of Plant Protection Products in SADC Member States” - the name of the document to include all pesticides and not just plant protection products (public health, veterinary agriculture, household, environment, etc.). - To include text that countries must align their law to the guidance document but do not have to follow it word for word. - Needs to be in-line/aligned with the new code. - Document has to be in-line with the registration tool kit. - HHP text should be included. Needs to be cognisant of the OECD guidance documents – mutual acceptance of data Needs to include SAPReF as it doesn’t mention it anywhere. A great opportunity for the inclusion of the “Full Life Cycle” Issues and questions: i) what is useful and should keep; ii) what’s useless and should throw away; and iii) what is missing? SAPReF should set up a registration database and decide on the mechanisms to put in place to ensure harmonisation The terms and conditions developed for the working group selected are within Annex 3 – Terms of reference for the technical working group and the consultant for the review of the regional guidelines for the regulation of plant protection products in SADC (2011) update working group. 53 WORKSHOP RECOMMENDATIONS 1. SAPReF to establish a working group to review the SADC Regional guidelines for the regulation of plant protection products 2. SADC Member Countries develop national action plans to reduce the risks posed by highly hazardous pesticides (HHPs), based on the outline elaborated by the Meeting 3. SAPReF to establish a working group to further develop a regional strategy for HHP risk reduction, along the lines agreed by the Meeting. 4. FAO, The Rotterdam Convention Secretariat, WHO, KEMI and UCT continue to provide support to SADC Member Countries for HHP risk reduction. 5. The SADC Secretariat to engage with SADC Member Countries with the aim to create highlevel national support for the reduction of health and environmental risks posed by HHPs and for the development of national action plans. 54 ANNEX 1: WORKSHOP AGENDA SAPReF HHP Workshop Agenda Holiday Inn - Rosebank, Johannesburg, South Africa April 25th – 29th, 2016 Date Sunday, April 24th Time All day Day 1 April 25th Activity Session Chair/Presenter Arrival in Johannesburg, South Africa OPENING SESSION Master of ceremony: 0830 – 0900 Registration 0900 – 0905 Welcoming Remarks – SAPReF Chair Loitseng Sebetwane 0905 – 0915 FAOR South Africa Tobias Takavarasha 0915 – 0925 Guest of Honour – RSA Official TBA 0925 – 0930 University of Cape Town (UCT) Andrea Rother - UCT 0930 – 0935 Swedish Chemical Agency (KemI) “Addressing pesticide use and identification of common issues in managing and reducing pesticide risk in Southern Africa.” All Lilian Törnqvist Date Time Activity Session Chair/Presenter 0935 – 1015 Introduction of participants All 1015 – 1030 Workshop objectives, programme, housekeeping matters 1030 – 1100 GROUP PHOTO; TEA & COFFEE BREAK Francesca Mancini Session Chair: 1100 – 1130 Highly hazardous pesticides – Why do we worry and what can we do? 1130 – 1200 The Mozambique pilot project 1145 – 1230 Overview of country information relevant to the management of HHPs 1230 – 1400 LUNCH 1400 – 1430 Understanding Hazards vs. Risks 1430 – 1500 Identification of HHPs: The criteria 1530 - 1600 TEA & COFFEE BREAK 1600 - 1700 Using the Pesticide Registration Toolkit to facilitate the identification of HHPs. 1700 Francesca Mancini Khalid Cassam Ivy Saunyama/ Harold van der Valk Andrea Rother Harold van der Valk Harold van der Valk CLOSURE OF THE DAY Day 2 April 26th Session Chair: 0830 – 0845 Summary of key findings of yesterday Reporting team 0845 – 1030 Identification of HHPs: review of individual pesticides Group work Harold van der Valk All 56 Date Time Activity Session Chair/Presenter 1030 - 1100 TEA & COFFEE BREAK 1100 – 1130 Identification of HHPs: review of individual pesticides Group work continued All 1130 - 1230 Identification of HHPs: review of individual pesticides Plenary discussion Harold van der Valk 1230 – 1400 LUNCH Session Chair: 1400 – 1500 Identification of HHPs: review of national lists of registered pesticides Group work All 1500 – 1530 Identification of HHPs Plenary discussion Harold van der Valk 1530 – 1600 TEA & COFFEE BREAK 1600 – 1700 Harmonized methodology for identification of HHPs in SAPReF? Discussion 1700 Lilian Törnqvist CLOSURE OF THE DAY Day 3 April 27th Session Chair: 0830 – 0845 Summary of key findings of yesterday Reporting team 0845 – 0915 HHP use survey – objectives and methods Ivy Saunyama 0915 – 1030 HHP use survey Group work 1030 – 1100 TEA & COFFEE BREAK 57 Date Time Activity 1100 – 1130 HHP use survey Group work continued 1130 – 1230 HHP use survey Plenary discussion 1230 – 1400 LUNCH Session Chair/Presenter Ivy Saunyama Session Chair: 1400 – 1430 Risk assessment – options and methods for human health and environmental risk assessment Harold van der Valk 1430 – 1445 Using the FAO Pesticide Registration Toolkit to facilitate risk assessments Harold van der Valk 1445 – 1530 Risk assessment – methods Group work Harold van der Valk 1530 – 1600 TEA & COFFEE BREAK 1600 – 1700 Risk assessment – methods Plenary discussion 1700 Lilian Törnqvist CLOSURE OF THE DAY Day 4 April 28th Session Chair: 0830 – 0845 Summary of key findings of yesterday Reporting team 0845 – 0930 Risk mitigation – options and constraints Harold van der Valk 0930 – 1030 Assessment of alternatives – options and constraints Ivy Saunyama Session Chair: 58 Date Time Activity Session Chair/Presenter 1030 – 1100 TEA & COFFEE BREAK 1100 – 1130 Regional coordination and collaboration for HHP risk reduction Harold van der Valk Session Chair: 1130 – 1200 Connecting it all with the Rotterdam Convention Nadia Correale – RC Secretariat 1200 – 1230 Implementing article 5 under information exchange and PIC procedure Presentation followed by group work Nadia Correale – RC Secretariat 1230 – 1400 LUNCH 1430 – 1500 Implementing article 5 under information exchange and PIC procedure Group work continued Plenary discussion 1500 – 1530 Implementing article 6 for SHPF (Severely Hazardous Pesticide Formulations) Presentation followed by group work 1530 – 1600 TEA & COFFEE BREAK 1600 - 1630 Implementing article 6 for SHPF (Severely Hazardous Pesticide Formulations) Group work continued Plenary discussion 1630 – 1700 Addressing challenges identified by the countries and way forward Discussion Nadia Correale – RC Secretariat 1700 – 1710 Survey on implementation of Code of Conduct Harold van der Valk 1710 CLOSURE OF THE DAY 59 Nadia Correale – RC Secretariat Date Time Day 5 April 29th Activity Session Chair/Presenter The way forward Session Chair: 0830 – 0845 Summary of key findings of yesterday Reporting team 0845 – 0915 Development of a HHP risk reduction action plan Harold van der Valk 0915 – 0930 FAO – Africa Solidarity Trust Fund Project Ronia Tanyongana 0930 – 1030 Development of a HHP risk reduction action plan Group work All 1030 – 1100 TEA & COFFEE BREAK 1100 – 1130 Development of a HHP risk reduction action plan Plenary discussion 1130 – 1230 SADC Regional Guidelines for the Regulation of Crop Protection Products in SADC Countries (2011) – Need for review? Ivy Saunyama Chiluba Mwape 1230 – 1400 LUNCH 1400 – 1500 Recommended strategy for HHP risk reduction in SADC member countries Plenary discussion Loitseng Sebetwane 1500 CLOSURE OF THE WORKSHOP SAPReF, SADC, FAO 1510 TEA & COFFEE BREAK 60 ANNEX 2 - LIST OF PARTICIPANTS AT SAPREF HIGHLY HAZARDOUS PESTICIDE WORKSHOP Country/Organization Name of participant Organization Email Address Telephone 1 Angola Paula Cachacha Ministry of Agriculture [email protected] +244-921-544-152 2 Botswana Loitseng Sebetwane Ministry of Agriculture [email protected] 3 Botswana Thato Sengwaketse Ministry of Health [email protected] 4 Botswana Collen Mbereki Ministry of Agriculture [email protected] Democratic Republic of Congo (DRC) Democratic Republic of Congo (DRC) Christian Ernest Kiaku Tebila Ministry Agriculture and Rural Development Ministry Agriculture and Rural Development 7 Lesotho Sekhonyana Mahase 8 Lesotho 9 5 +267-392-8768 +267-392-8745 +267-317-0531 +267-7149-8566 +267-392-8745 +267-7536-4577 [email protected] +243-9900-744-553 [email protected] +243-8152-927-37 Ministry of Agriculture [email protected] [email protected] Rorisang Mantutle Ministry of Agriculture [email protected] +266-2232-4827 +266-6302-2361 +266-2232-4827 +266-5884-0271 Madagascar Arsonina Bera Ministère de l'Environnement et des Forêts 10 Madagascar Désiré Rabakoarijao Ministry of Agriculture 11 Malawi Caroline Theka Ministry of Environment 12 Malawi Misheck Soko Ministry of Agriculture 13 Mauritius Rakeshwar Goorah Ministry of Health 14 Mauritius Shradanand Permalloo Ministry of Agriculture [email protected] +230-466-6434 Samson Cuamba National Environmental Control Quality Agency (AQUA), Ministry of Land, Environment and Rural Development (MITADER) [email protected] [email protected] +258-1823-338805 6 15 Mozambique Risasi Mutiri 61 [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] [email protected] +261-340-562-036 +261-331-120-975 +265-995-501-006 +265-471-4719/312 +230-213-4644 Fax: +230-213-4645 Ministry of Agriculture and Food Security Ministry of Agriculture, Water and Forestry Ministry of Agriculture, Water and Forestry [email protected] [email protected] +258-8284-25370 [email protected] +264-612-087-463 [email protected] +264-612-087-469 Samuel Brutus Ministry of Agriculture [email protected] Seychelles Julita William Ministry of Health [email protected] 21 South Africa Nkoane Madumise 22 South Africa Precious Mkula 23 South Africa Brenda Maphanga 24 South Africa Gordon Khauoe 25 Swaziland Bianca Dlamini 26 Swaziland Phindile Dlamini 27 Tanzania Elikana Lekei 28 Tanzania Jeniva Kumuhabwa 29 Zambia Cliff Ngwata 30 Zambia David Kapindula Ministry of Environment [email protected] 31 Zimbabwe Kenneth Chipere Ministry of Agriculture [email protected] 32 Zimbabwe Nzira Lukwa National Institute of Health Research [email protected] 16 Mozambique Anastacio Luis 17 Namibia Paulina Pashukeni Shilunga 18 Namibia Ndeshihafela Haindongo 19 Seychelles 20 Department of Environmental Affairs (DEA) Department of Agriculture, Fisheries and Forestry (DAFF) Department of Environmental Affairs (DEA) Department of Environmental Affairs (DEA) +248-461-1475 +248-256-6136 +248-252-6835 +248-438-8056 [email protected] +27-12-399-9801 +27-76-079-8474 [email protected] +27-12-319-7301 [email protected] +27-12-399-9769 +27-72-815-8189 [email protected] +27-12-399-9769 Ministry of Environment [email protected] +268-2404-1719 Ministry of Agriculture [email protected] +268-2404-2731 [email protected] +255-756-833-135 Tropical Pesticides Research Institute (TPRI) Ministry of Agriculture, Livestock and Fisheries Zambia Environmental Management Agency, Ministry of Environment 62 [email protected] [email protected] +255-754-845-846 +260-212-621-048 +260-211-254-130 +260-977-822-306 +263-773-526-507 +263-4-704-542/3 +263-4-253-975/-8 33 FalConsult Harold van der Valk FalConsult [email protected] 34 FAO Francesca Mancini FAO - AGPMC [email protected] 35 FAO Nadia Correale FAO - Secretariat of the Rotterdam Convention [email protected] +39-3495-9570-48 36 FAO Joyce MulilaMitti FAO SFS [email protected] +233-203-360-643 37 FAO Ivy Saunyama FAO SFS [email protected] +263-772-250-368 38 FAO Ronia Tanyongana FAO SFS [email protected] 39 FAO Khalid Cassam FAO-Mozambique [email protected] +258-82-307-1000 40 FAO Rutendo Tinarwo FAO SFS [email protected] +263-77-294-2100 41 KemI Lilian Törnqvist KemI [email protected] 00-96-765-061-160 42 UCT Hanna-Andrea Rother [email protected] +27-21-406-6721 43 UCT Nanziwe Khumalo [email protected] +27-7853-743-85 44 Africa Institute Koebu Khalema [email protected] +27-12-399-9863 UCT Environmental Health Division UCT Environmental Health Division Africa Institute 63 +31-183-500410 64 ANNEX 3 – TERMS OF REFERENCE FOR THE TECHNICAL WORKING GROUP AND THE CONSULTANT FOR THE REVIEW OF THE REGIONAL GUIDELINES FOR THE REGULATION OF PLANT PROTECTION PRODUCTS IN SADC (2011) UPDATE WORKING GROUP 1.0 Background SADC member states under the Food Safety – Capacity Building on Residue Control Project, developed Regional Guidelines for the Regulation of Plant Protection Products in SADC Countries to assist them to strengthen the regulatory framework for registration and quality control of crop protection products at national and SADC regional level. The guidelines follow the recommendations provided by the FAO and WHO International Code of Conduct on Pesticide Management (FAO and WHO, 2014). The SADC guidelines list the obligations of member State national governments. The main objective was to ensure that national governments meet these obligations for the purposes of food security and safety, human and environmental health and international trade in food commodities. To overcome these constraints in the SADC region and to make the best possible use of expertise and resources, member states agreed that crop protection products (including public health pesticides, industrial herbicides and small householder packs) policies, legislation, registration and control be harmonized in the region. This includes registration procedures, requirements, guidelines, import and export control, compliance to the requirement that only registered and correctly labelled products may be sold, quality assurance and the accreditation of premises, distributors and applicators. Southern Africa Pesticides Regulatory Forum (SAPReF), since 2014 is a technical subcommittee under the SADC plant protection technical committee. SAPReF is therefore responsible for all pesticides issues, with all member states represented. SAPReF has noted some shortfalls in the current SADC guidelines of 2011 and has been tasked to review and update to include the new Code of Conduct and also properly aligned to the relevant conventions and standards. SCOPE OF THE ASSIGNMENT The aim of the assignment is to review the current Guidelines for Regulating Plant Protection Products in light of the observed deficiencies and then initiate the process of harmonization and domestication within SADC. SAPReF will form a Technical Working Group (TWG), which will guide and oversee the implementation of the whole task, from review of the guideline, including national consultation with member states to domestication. This will be through the SADC secretariat, responsible for Sanitary and Phytosanitary issues. Presented here are the two TOR’s, for the Working Group and the consultant who will oversee the review of the guideline updating process. It is expected that the guidelines will provide for the: • Protection of the health of human beings, animals and plants. • Safeguard of the environment. • Implementation of secure, safe, efficient, humane and ethical methods of controlling pests. • Transparency in trade of agricultural products within and outside the SADC region. • Raising of public awareness on pesticides. • Development of a legal framework for the management and control of pesticides, including MRLs. • An inclusive guideline that would also effectively cover Highly Hazardous Pesticides (HHPs) and non-crop pesticides e.g. pesticides used in public health and vectors 2.0 Purpose/Aim The purpose of this review is to produce a more inclusive, harmonized and up-to-date guideline for regulating pesticides in the SADC member states in order to safeguard human, plant life and the environment while also ensuring products from the region are accepted in international markets as safe; and to bring in-line with international conventions, Codes and standards 3.0 Procedure To update the Regional Guidelines for the Regulation of Plant Protection Products in SADC (2011) and to promote a process for future domestication of these guidelines throughout all the SADC member States. Step 1: SAPReF Steering Committee (EXCO) to work with funders of this project to draw up a contract for the consultant Step 2: Appoint a consultant ToRs for the consultant Step 2.1 To identify relevant, useful, redundant and missing elements of the guidelines (and change the title) in consultation with EXCO. Step 2.2 Make a presentation of the findings to the technical working group, including cooperating technical partners and produce a final draft. Step 2.3 To incorporate in the guideline SAPReF and its role, as a focal point for SADC in pesticides related issues in the region. Step 2.4 To ensure the guidelines are inclusive of all pesticides, as defined by the FAO/WHO Code of Conduct on Pesticide Management, therefore referred 66 Step 2.5 Step 2.6 Step 2.7 Step 2.8 Step 2.9 to as “Regional Guidelines for the Regulation of all Pesticide Products in SADC Member States.” To align the guideline with the FAO/WHO official guidelines under the International Code of Conduct on Pesticide Management. To spearhead the discussion within the region on domestication of the guidelines Elaborate harmonized pesticide registration requirements and the modality for implementation in the region. Make a presentation of the final draft for validation to/by SAPReF. Produce an agenda and the concept for the national workshops Step 3: Set up a Technical Working Group ToRs for the Technical Working Group The technical working group, whose composition is as listed below and the chair who will be appointed by SAPReF, is expected to have the following Terms of Reference: Step 3.1 Step 3.2 Step 3.3 Step 3.4 Step 3.5 Step 3.6 Step 3.7 To guide and monitor the process of reviewing the guidelines based on the stipulated timelines From time to time review progress made by the consultant Participate in the review Arrange for presentation of the drafts and the participation of all relevant stakeholders. Present the guideline document to SADC for its member states’ adoption and domestication. Facilitate the process of national consultations The working group in collaboration with the consultant will establish the final version of the guidelines for review by EXCO to be sent to SADC. 4.0 Membership of the TWG 4.1 The working group will comprise of each Member State. Attendance is limited to one member per State for the working group. Angola Mozambique Botswana Namibia Democratic Republic of Congo Seychelles (DRC) South Africa Lesotho Swaziland Madagascar Tanzania Malawi Zambia Mauritius Zimbabwe 67 4.2 Technical experts may be drawn from: Swedish Chemical Agency (Keml) University of Cape Town (UCT) Food and Agricultural Organization of the United Nations(FAO) World Health Organisation (WHO) 4.3 National Consultations on Guidelines 5.0 Governance 5.1 The activities of the working group will be overseen by the SAPReF Steering Committee. 5.2 The Chair of the working group may recommend to the SAPReF Steering Committee Board to suspend the membership of a particular member to attend two consecutive meetings of the working group without proper justification. 5.3 The Food and Agriculture Organisation of the United Nations (FAO), Swedish Chemical Agency (KemI), University of Cape Town (UCT), and World Health Organisation (WHO) will provide technical guidance and support for the update and domestication of the guidelines. 6.0 Meetings The working group will meet at regular intervals at least once a month, with each meeting lasting at least one and half hours. Extraordinary meetings may be called when required. To minimize costs, the TWG will conduct most of its meetings virtually and will be conducted in English only. 7.0 Funding The working group will develop a project proposal for funding for both the review and domestication of the guidelines. 68 Time Frame Due DATE TASK 29 April, 2016 EXCO to appoint TWG chair and group members 15 May 2016 TWG to develop a work plan and budget. Chair submit to EXCO (online meeting; secretarial support from UCT/Nanzi) 1st week of May (meeting) 15 July, 2016 EXCO and funder to appoint consultant 30 August, 2016 Consultant to develop draft document and present to TWG 15 September, 2016 TWG to review draft document and submit comments to consultant 30 September, 2016 Consultant to produce the second working draft to EXCO 7 October, 2016 EXCO to review and send comments to consultant 15 October, 2016 Consultant to produce third draft 30 November, 2016 SAPReF members to hold national consultations with third working draft of guideline 15 December, 2016 Consultant incorporates findings and comments from national workshops in conjunction with the TWG and develop final draft and submits to EXCO for final endorsement 20 December, 2016 EXCO endorses final guideline and send to all SAPReF members SAPReF members to endorse the final guidelines SAPReF chair to submit the guidelines for SADC approval 69
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