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January 2007 This publication was produced for review by the United States Agency for International Development. It was prepared by RTI International with contributions from International Resources Group.
Prepared for Bureau for Global Health United States Agency for International Development Prepared by RTI International 3040 Cornwallis Road Post Office Box 12194 Research Triangle Park, NC 27709-2194
RTI International is dedicated to conducting research and development that improves the human condition by turning knowledge into practice. With a staff of more than 2,500, RTI offers innovative research and technical solutions to governments and businesses worldwide in the areas of health and pharmaceuticals, education and training, surveys and statistics, democratic governance, economic and social development, advanced technology, energy, and the environment. The second largest independent nonprofit research organization in the United States, RTI maintains nine offices in the U.S., five international offices, and one international subsidiary, as well as project offices around the world. RTI International is a trade name of Research Triangle Institute.
The authors views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the United States Government.
List of Preparers
Melanie Biscoe Anne Lewandowski John Gaudet Mary Linehan Stephen Beaulieu Susan Wolf Nicole Van Abel Alexandra Zapata Gayle Kebede Preethi Sama Elizabeth Hennessy Aisha Caruth Gail Hayes Felice Sinno-Lai Anne Crook Lutes Craig Hollingsworth Alan Schroeder Greg Booth Andy Arata Environmental Scientist, International Development Group, RTI International Senior Manager, Environment and Natural Resources Division, International Resources Group Consultant Senior Health Specialist, International Development Group, RTI International Senior Risk Assessor, Environmental Health and Safety Division, RTI International Health Scientist, Environmental Health and Safety Division, RTI International Environmental Modeler, Environmental Health and Safety Division, RTI International Environmental Scientist/Modeler, Environmental Health and Safety Division, RTI International Health Scientist, Environmental Health and Safety Division, RTI International Health Scientist, University of North Carolina Writer/Editor, International Development Group, RTI International Writer/Editor, International Development Group, RTI International Publications Specialist, International Development Group, RTI International Publications Specialist, International Development Group, RTI International Technical Writer/Editor, Science and Engineering Group, RTI International Writer/Editor, Publication Services Group, RTI International Consultant Consultant Consultant
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Consultant Consultant
Acknowledgements Eugene Brantly Douglas Crawford Brown Program Leader, Malaria and Environmental Health, RTI International Peer Reviewer, University of North Carolina
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Table of Contents
Page List of Preparers....................................................................................................iii Table of Contents.................................................................................................. v List of Figures ......................................................................................................vii List of Tables ......................................................................................................viii List of Acronyms .................................................................................................. ix Executive Summary.............................................................................................. 1 Key Recommendations ................................................................................... 2 1. Introduction...................................................................................................... 5 1.1 Objective of the PEA .............................................................................. 6 1.2 PEA Scoping Statement ......................................................................... 8 1.3 Limitations of the PEA .......................................................................... 10 1.4 Assessment Methodology .................................................................... 11 2. Background on Malaria and Malaria Vector Control ...................................... 12 3. Proposed Actions and Alternatives ................................................................ 16 3.1 IVM Alternatives Evaluated and Not Evaluated in the PEA .................. 16 3.2 Methods for Controlling AdultsIRS .................................................... 16 3.3 Methods for Controlling LarvaeLarvicidal Agents.............................. 18 3.4 Methods for Controlling LarvaeEnvironmental Management ............ 19 3.5 Alternatives Not Recommended by this Assessment ........................... 23 3.6 A Note on Developing Technologies .................................................... 24 4. Affected Environment .................................................................................... 27 5. Human Health and Environmental Consequences ........................................ 28 5.1 Human Health Consequences: Indoor Residual Spraying (IRS), Insecticide-Treated Nets (ITNs), and Larviciding.................................. 28 5.2 Environmental ConsequencesIRS .................................................. 105 5.3 Environmental ConsequencesLarvicides ........................................ 112 5.4 Human Health and Environmental Consequences Environmental Management............................................................... 113 6. Mitigation, Monitoring, and Evaluation......................................................... 117 6.1 Mitigation and Monitoring: Planning and Recommendations.............. 117 6.2 Evaluation and Adaptive Management ............................................... 146 7. Regulatory, Legal, and Institutional Settings................................................ 148 7.1 The National Setting ........................................................................... 148 7.2 The International Setting .................................................................... 149
Integrated Vector Management Programs for Malaria Control
8. Training and Institutional Capacity Building ................................................. 152 8.1 Why Training and Capacity Building?................................................. 152 8.2 Training of Contractors (1 day) ........................................................... 152 8.3 Guidance for Senior Officials (12 days) ............................................ 152 8.4 Mid-Level Management (continuous, time-intensive training as necessary) ..................................................................................... 153 8.5 Training of Implementers (13 weeks) ............................................... 153 8.6 Capacity Building outside the Malaria Sector ..................................... 154 9. Cross-Cutting Issues ................................................................................... 155 9.1 Malaria Control and the Agricultural Sector ........................................ 155 9.2 Malaria Control and Hazardous Waste Management ......................... 157 10. Public Consultation Process ........................................................................ 159 11. Bibliography................................................................................................. 163 11.1 Documents Consulted..................................................................... 163 11.2 Web sites Consulted ....................................................................... 167 Annex A: Annex B: Annex C: Annex D: Annex E: Annex F: Annex G: Annex H: Annex I: Annex J: Annex K: Annex L: Scoping Statement ...................................................................... A-1 USAID Environmental Procedures (22 CFR 216)........................ B-1 Guidance for Developing SEAs for Malaria Vector Control Programs ........................................................................ C-1 Input Parameter Tables ............................................................... D-1 Pesticide Profiles......................................................................... E-1 Pathways by Chemical and Intervention ......................................F-1 Exposure and Risk Calculations.................................................. G-1 Screening Risk Results ............................................................... H-1 Treatment Guidelines for WHO-Recommended Insecticides for Indoor Residual Spraying .........................................................I-1 CODEX Maximum Residue Limits................................................ J-1 Stockholm Convention Questionnaire for Reporting on Production and Use of DDT for Disease Vector Control .............. K-1 Public Comments Received .........................................................L-1
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List of Figures
Page Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. Figure 6. Figure 7. Figure 8. Figure 9. Figure 10. Figure 11. Role of the Risk Assessment Framework in Developing IVM Strategy.................................................................................. 29 Overall Conceptual Model for Possible Exposure Pathways from IVM Practices ........................................................................ 50 Conceptual Model for Possible Exposure Pathways from Preparation of Pesticide ................................................................ 52 Conceptual Model for Possible Exposure Pathways from IRS ...... 53 Conceptual Model for Possible Exposure Pathways from ITNs....................................................................................... 54 Conceptual Model for Possible Exposure Pathways from Liquid Larviciding........................................................................... 55 Conceptual Model for Possible Exposure Pathways from Granular Larviciding ...................................................................... 55 Conceptual Model for Possible Exposure Pathways from Disposal of Excess Pesticide Formulation..................................... 56 Conceptual Model for Possible Exposure Pathways from Reuse of Pesticide Containers .............................................. 59 Conceptual Model for Possible Exposure Pathways from Storage of Pesticides..................................................................... 60 Detailed View of the Pesticide Risk Assessment Process ............. 62
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List of Tables
Page Table 1. Table 2. Table 3. Table 4. Table 5. Table 6. Table 7. Table 8. Table 9. Table 10. Table 11. Table 12. Table 13. Table 14. Table 15. Table 16. Table 17. Table 18. Table 19. Table 20. Table 21. Table 22. Table 23. Table 24. Table 25. Table 26.
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Key Issues to Be Analyzed in the PEA ............................................ 8 IRS Insecticides Evaluated in this PEA ......................................... 17 Pesticide Use by Intervention ........................................................ 32 U.S. Pesticide Registration Status Determination of Same or Similar Use Patterns...................................................................... 34 ChemicalPhysical Properties That Affect Environmental Behavior1 ....................................................................................... 36 Formulations of Pesticides Used in IVM........................................ 51 Combustion Byproducts of Pesticides ........................................... 57 Pathways by Pesticide and Intervention........................................ 64 Noncancer Screening Results ....................................................... 84 Cancer Screening Results............................................................. 86 Risk Results for IRS1 ..................................................................... 95 Risk Results for ITN Retreatment1................................................. 96 Risk Results for Container Reuse.................................................. 96 Risk Results for Groundwater Contamination1 .............................. 97 Risk Results for IRS1 ..................................................................... 98 Risk Results for ITN Retreatment1................................................. 98 Risk Results for Container Reuse.................................................. 99 Risk Results for Groundwater Contamination1 .............................. 99 Toxicity of IRS Insecticides to Nontarget Organisms ................... 106 Ranking of Environmental Management Interventions from Low Impact to High Impact .......................................................... 115 IRS Recommendations................................................................ 125 Larviciding Recommendations .................................................... 139 Environmental Management Recommendations......................... 144 Host-Country Institutions with Malaria Control Mandates or Related Functions ....................................................................... 148 Illustrative List of Organizations and Programs ........................... 151 Summary of Public Consultation Issues ...................................... 160
Integrated Vector Management Programs for Malaria Control
List of Acronyms
ADD ATSDR BEO Bti CAS CFR CGIAR CSF DAF DDT EA EC EC50 EIR EPA EXTOXNET GDP GEF GFATM GIS GUP HEAST HI HQ HSDB IARC ICIPE IEC IEE IPCS IPM IRIS IRS ITM ITN IUCN IVM KAP LADD LC50 LD50 LLIN LOAEL MEO MHO average daily dose Agency for Toxic Substances and Disease Registry Bureau Environmental Officer Bacillus thuringiensis israelensis Chemical Abstracts Service U.S. Code of Federal Regulations Consultative Group on International Agricultural Research cancer slope factor dilution and attenuation factor dichloro-diphenyl-trichloroethane environmental assessment emulsifiable concentrate median effective concentration entomological inoculation rate U.S. Environmental Protection Agency EXtension TOXicology NETwork gross domestic product Global Environment Fund Global Fund for AIDS, Malaria and Tuberculosis geographic information systems general use pesticide health effects assessment summary tables hazard index hazard quotient Hazardous Substances Data Bank International Agency for Research on Cancer The International Center for Insect Physiology and Ecology Information, Education, and Communication Initial Environmental Examination International Program on Chemical Safety integrated pest management integrated risk information system indoor residual spraying insecticide-treated material insecticide-treated net The World Conservation Union integrated vector management knowledge, attitudes, and practices lifetime average daily dose median lethal concentration lethal dose, 50 percent of the test population long-lasting insecticidal net lowest observed adverse effect level Mission Environmental Officer Mission Health Officer
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MOA MOE MOH MOS MPW MRL MRLs NC NGO NOAEL NOEL OFDA PAN PEA PERSUAP POPs PPE PSCs PVO RAGS RBM RED REO RfD RUP SEA SF SIMA SOP UF ULV UNDP UNEP UNFAO UNICEF USAID USDA/FAS WHO WHOPES WP
Ministry of Agriculture margin of exposure Ministry of Health Margin of Safety Ministry of Public Works minimal risk level maximum residue limits noncancer nongovernmental organization no observed adverse effect level no observed effect level Office of Foreign Disaster Assistance Pesticide Action Network Programmatic Environmental Assessment Pesticide Evaluation Report and Safer Use Action Plan persistent organic pollutants personal protective equipment pyrethrum spray catches private voluntary organization Risk Assessment Guidance for Superfund Roll Back Malaria reregistration eligibility decision regional environmental officer reference dose restricted use pesticide Supplemental Environmental Assessment safety factor System Wide Initiative On Malaria And Agriculture standard operating procedure uncertainty factor ultra-low volume United Nations Development Program United Nations Environment Program United Nations Food and Agriculture Organization United Nations Childrens Fund U.S. Agency for International Development U.S. Department of Agriculture/Foreign Agricultural Service World Health Organization WHO Pesticide Evaluation Scheme wettable powder
Executive Summary
The U.S. Agency for International Development (USAID) Office of Global Health contracted RTI International to conduct a Programmatic Environmental Assessment (PEA) to serve as an umbrella evaluation of environmental and human health issues related to malaria vector control and to assist with the preparation of country- and activity-specific Supplemental Environmental Assessments (SEAs) for malaria vector control programs. This PEA provides USAID project managers with the policy, procedural, and technical guidelines to choose appropriate interventions and insecticides and develop and implement mitigation and monitoring and evaluation activities. This, in turn, will allow Missions to design malaria vector control programs in more efficient and cost-effective ways. The integrated vector management (IVM) PEA is composed of the following sections: Section 1Introduction. The introduction provides an overview of the purpose and objectives of the PEA. Section 2Background on Malaria and Malaria Vector Control. Section 3Proposed Actions and Alternatives. This section discusses proposed actions and alternatives, including indoor residual spraying (IRS), insecticidetreated nets (ITNs) (limited evaluation), environmental management, and larviciding, as well as alternatives that are not recommended (including the no action alternative). Section 4Affected Environment. This section provides an overview of issues to be considered when discussing the intervention area environment in country specific environmental assessments. Section 5Human Health and Environmental Consequences. This section discusses the Phase I screening risk assessment that was conducted for the purpose of informing USAID on the human health risks of IRS, ITNs, and larvicides. Section 6Mitigation, Monitoring, and Evaluation. Section 7Regulatory, Legal, and Institutional Setting. This section provides an overview of regulatory, policy, and institutional capacity issues to be considered during the preparation of country-specific environmental assessments. Section 8Training and Institutional Capacity Building. In this section, the PEA provides suggestions for training and institutional capacity building for program quality and sustainability. Section 9Cross-Cutting Issues. Three cross-cutting issues are addressed in this section, including interaction with the agricultural sector, hazardous waste management, and prevention versus treatment of malaria.
Section 10Public Consultation Process. This section summarizes the public consultation process that was conducted at the scoping stages and for various draft versions of this PEA. Section 11Bibliography.
A separate guidance document for preparing SEAs, entitled Guidance for Developing SEAs for Malaria Vector Control Programs, can be found in Annex C. The intended audience and users of this PEA, entitled Management Programs for Malaria Control: Programmatic Environmental Assessment, include malaria control program decision makers, designers, and implementers; USAID Washington Program Officers, Mission Health Officers (MHOs), and Mission Environment Officers (MEOs); host country health and environment officials; Office of Foreign Disaster Assistance (OFDA) Officers; individuals preparing Initial Environmental Examinations (IEEs) and SEAs; and the general public. Key Recommendations Prohibit the use of interventions not supported by this PEA (Section 3.5). Ensure any intervention chosen complies with international treaties, as well as host country and U.S. government laws, regulations and guidelines (Sections 7.1 and 9.2). Use entomological surveillance and disease surveillance to select appropriate locations, interventions, and times for implementation. Location-specific criteria that should be used to select an appropriate intervention include, but are not limited to, climate, vector behavior, vector habitat, cost-effectiveness, pesticide target environment interactions, political and stakeholder commitment, financial sustainability and human resources, and impacts on agricultural export markets (Sections 6.1 and 9.1). Promote host country selection of pesticides based on criteria found in Section 6.1. Integrate environmental and human health concerns into the planning stages of the intervention (Section 6.1). Determine intervention-specific mitigation, monitoring and evaluation activities to be implemented based on recommendations in this PEA and the insecticidetreated materials (ITM) PEA, as well as consultations with host country stakeholders (Section 6.1). Promote host country compliance with requirements and recommendations for dichloro-diphenyl-trichloroethane (DDT) use under the Stockholm Convention (Section 6.1). Monitor the implementation and effectiveness of mitigation activities (Section 6.1).
Monitor the impacts of the intervention on the environment, livestock, workers, and communities. (Environmental monitoring is required for support of DDT use in IRS, and cholinesterase monitoring is required for support of organophosphate use in IRS) (Section 6.1). Monitor the effectiveness of the intervention on malaria vector populations (Section 6.1). Monitor the effectiveness of the intervention on malaria incidence (Section 6.1). Consolidate all monitoring results in a Human Health and Environmental Evaluation report, containing elements listed in the PEA (Section 6.2). Adapt management of the malaria vector control program according to results found in the Human Health and Environmental Evaluation Report (Section 6.2). Provide training to contractors on factors to consider in intervention and insecticide selection, potential impacts of pesticides, best practices and mitigation measures, adaptive management, and any other identified topics of concern (Section 8.2). Provide capacity building activities for senior government officials on factors to consider in intervention and insecticide selection, potential impacts of insecticides, best practices and mitigation measures, appropriate timing and logistics, adaptive management, and any other identified topics of concern (Section 8.3). Provide capacity building activities for mid-level management on logistics, data management, best practices and mitigation measures, monitoring and evaluation (of all types mentioned in this PEA), surveillance systems, adaptive management, and any other identified topics of concern (Section 8.4). Provide for capacity building of institutions outside the malaria sector to improve intervention mitigation and monitoring capabilities in the host country (Section 8.6). Train intervention implementers according to the highest standards available (for instance, WHO guidelines, PEA guidelines, United Nations Food and Agriculture Organization guidelines, equipment manufacturer guidelines, pesticide industry guidelines, ministry guidelines, etc.) (Section 8.5). When pesticides are used in an intervention, train pesticide storekeepers, medical practitioners, individuals transporting pesticides, and communities on their roles and responsibilities in preventing unwanted exposure of pesticides (or treating exposure, in the case of medical practitioners) (Section 8.5). When hazardous waste or potential obsolete pesticide stocks are identified during planning or implementation of an intervention, follow the protocol described in Section 9.2 of this PEA.
Assist host countries with activities pertaining to DDT compliance requirements of the Stockholm Convention, if they are using USAID-procured DDT for disease vector control, are Parties to the Convention, and have a DDT use exemption under Stockholm (Section 9.2.3). Conduct SEAs to supplement this PEA in accordance with the Guidance for Developing SEAs for Malaria Vector Control Programs in Annex C.
1.
Introduction
The U.S. Agency for International Development (USAID) estimates 300 to 500 million worldwide cases of malaria occur every year, resulting in up to 2.5 million deaths mostly among young children. Since the start of USAIDs Infectious Disease Initiative in 1998, the Agency has significantly increased its programs and funding to fight malaria, particularly in Africa, where 90 percent of malaria deaths occur. USAIDs malaria programs focus on assisting countries to develop the capacity to effectively prevent and treat malaria through an integrated approachintegrated vector management (IVM) that uses a range of interventions designed to eliminate or greatly reduce malaria transmission. On June 30, 2005, President Bush pledged to increase funding for malaria prevention and treatment by more than $1.2 billion over 5 years, specifically in subSaharan Africa. To launch the Presidents Malaria Initiative, the United States will significantly expand resources for malaria prevention and treatment in Angola, Tanzania, and Uganda starting in 2006; expand to four more highly endemic African countries in 2007; and at least five more in 2008. This effort is expected to cover more than 175 million people in 15 or more of the most affected African countries. Given this recent expansion of USAID malaria control programs and the Agencys prominent role as a key member of the Roll Back Malaria (RBM) Partnership,1 it decided to prepare a PEA to evaluate potential generic environmental and human health effects of the various methods composing IVM. As a federal government agency, USAID is subject to U.S. environmental laws and regulations, which are applicable to all its programs, projects, and activities. Implementation of these through environmental impact assessment ensures that USAID development programs are not only economically sustainable but protect the host countrys residents, malaria control workers, and environment. Title 22, Code of Federal Regulations, Part 216 (22 CFR 216)Regulation 216, defines USAIDs environmental impact assessment procedures.2 Regulation 216, Section 216.6 (d) states that Program Assessments may be appropriate in order to: assess the environmental effects of a number of individual actions and their cumulative environmental impact in a given country or geographic area; or the environmental impacts that are generic or common to a class of agency actions; or other activities which are not country-specific.
The Roll Back Malaria Partnership, launched in 1998 by the WHO, United Nations Development Program, UNICEF, and the World Bank, aims to provide a coordinated global approach to fighting malaria and halving its burden by 2010. 2 The complete text of USAID environmental procedures, including pesticides procedures, can be found in Annex B of this PEA.
Developing a PEA for IVM is appropriate, as the environmental and human health impacts are, in some respects, generic. The World Health Organization (WHO) only supports the use of twelve pesticides for IRS, and countries generally do not use pesticides that are not supported by WHO for this activity. The potential effects of these IVM chemicals on humans and the environment are similar regardless of location. This PEA addresses the environmental and human health effects of IVM activities that are not country specific. The information contained in this PEA, as indicated by the Code of Federal Regulations, will serve to expedite future USAID environmental documentation processes by providing reference material for Initial Environmental Examinations (IEEs), SEAs, Pesticide Evaluation Reports and Regulation 216.3(b)Pesticide Procedures Safer Use Action Plans (PERSUAPs), or other individual environmental Factors to be considered when assessing the use assessments that address countryof pesticides in project activities: EPA registration status of the requested specific USAID support for IVM pesticide activities. A preliminary PEA for IVM was prepared in mid-2004. The initial draft was revised in 2005 and 2006, and was vetted with a broad spectrum of stakeholders in Washington, DC, and overseas. 1.1 Objective of the PEA