COVERSHEET

SCOPING STATEMENT FOR THE LARGE-SCALE RELEASE OF WOLBACHIA-INFECTED MOSQUITOES IN MEDELLÍN, COLOMBIA

PROGRAM/ACTIVITY DATA Program/Activity Number AID-OAA-F-16-00081 Program/Activity Title Grant: Pilot Deployment of Wolbachia Technology to Reduce

Transmission of Aedes aegypti-borne Diseases in Colombia Country/Region Colombia/LAC USG Foreign Assistance Framework Investing in People

3.1 Health Program Period Covered October 3, 2016 – October 2, 2018 Life of Project Amount $4,600,000 Scoping Statement (SS) Prepared By Cloudburst-Tellevate Team under the GEMS II Contract Management Unit Contact Point Marissa Leffler Current Date May 31, 2017 Expiration Date October 2, 2018

APPROVAL OF THE ENVIRONMENTAL SCOPING STATEMENT

CLEARANCE:

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Marissa Leffler Acting Director and AOR, Global Health Bureau Center for Accelerating Innovation, and Impact

Date

CONCURRENCE:

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Rachel Dagovitz Global Health Bureau Environmental Officer

Date

DISTRIBUTION LIST:

AOR is responsible for distributing the SS to stakeholders on the distribution list below. Stakeholders may include Regional BEOs, and REAs, among others. - Diana Shannon, Bureau Environmental Officer, Latin America Bureau - Laura Chittenden, Zika Regional Coordinator, Latin America Bureau - María Elena Santana, Mission Environmental Officer, Colombia

SCOPING STATEMENT FOR THE LARGE-SCALE RELEASE OF WOLBACHIA-INFECTED MOSQUITOES IN MEDELLÍN, COLOMBIA

June 16, 2017

BETZY COLON/TELLEVATE

DISCLAIMER This document was produced for review by the United States Agency for International Development. It was prepared by The Cloudburst Group and Tellevate under USAID Global Environmental Management Support project (GEMS II), Award Number AID-OAA-M-13000018 Task Order GH21.

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TABLE OF CONTENTS 1. Introduction .............................................................................................................................................. 2

1.1 Project Background ............................................................................................................................. 2

1.2 Project Purpose ................................................................................................................................... 3

1.3 Scoping Statement Objective .............................................................................................................. 3

1.4 Scoping Methodology ......................................................................................................................... 4

2. Existing Conditions .................................................................................................................................... 5

3. Description of Project Activities ................................................................................................................ 6

3.1 Geographic Scope ............................................................................................................................. 10

4. Applicable Laws, Regulations, and Policies ............................................................................................. 12

5. Potential Environmental Impacts and Significance................................................................................. 13

5.1 Description of Potential Environmental Impacts .............................................................................. 13

5.2 Significant Issues ............................................................................................................................... 16

5.3 Non-Significant Issues ....................................................................................................................... 16

5.4 Benefits ............................................................................................................................................. 17

6. Mitigation and Monitoring Controls ....................................................................................................... 18

6.1 Mosquito Insectary and Laboratory Controls ................................................................................... 18

6.2 Experimental Field Trial Controls ...................................................................................................... 18

7. Information Gaps/Surveys Needs ........................................................................................................... 20

8. Feasible Alternatives ............................................................................................................................... 21

8.1 Alternative 1: No Action .................................................................................................................... 21

8.2 Alternative 2: Proposed Action ......................................................................................................... 21

8.3 Alternative 3: Increase Use of Pesticides .......................................................................................... 21

9 Recommendations ................................................................................................................................... 22

10. References ............................................................................................................................................ 23

Annex A: EDP and PECET Overview and Collaboration ............................................................................... 24

Annex B: Names and Qualifications of Scoping Team ................................................................................ 25

Annex C: Names of Participants .................................................................................................................. 26

Annex D: Site Visit Agenda .......................................................................................................................... 27

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1. INTRODUCTION

1.1 PROJECT BACKGROUND

Zika is a virus that is transmitted to people through the bite of infected Aedes mosquitoes. The virus was first identified in humans in 1952 in Uganda and Tanzania. Since then, outbreaks of the disease have been recorded in Africa, the Americas, Asia and the Pacific1. Most recently, a widespread epidemic of Zika was reported in Brazil and quickly spread to other parts of the Americas causing the World Health Organization (WHO) to declare the Zika virus and associated health threats an international public health emergency.

In response to the Zika outbreaks, the USAID Bureau for Global Health (GH) Center for Accelerating Innovation and Impact (CII) launched Combating Zika and Future Threats: A Grand Challenge for Development in April 2016, which called upon the global innovator community to generate cutting-edge approaches to fight the current Zika outbreak and help strengthen the world’s ability to prevent, detect, and respond to future infectious disease outbreaks. In just two months, the Challenge received close to 900 applications, and after a rigorous review process, 26 potentially game-changing solutions were selected for accelerated development, testing, and deployment. The Eliminate Dengue Program (EDP), a not-for-profit, international research program led by Monash University (MU) in Australia, was among the awardees, and their research aims to use Wolbachia as a novel and sustainable approach to control the transmission of vector-borne diseases, including the Zika, dengue and chikungunya RNA arboviruses. This work is being conducted in collaboration with the Foundation of the Universidad of Antioquia (UA) and the Programa de Estudio y Control de Enfermedades Tropicales (PECET) at UA. Additional information on the research team is provided in Annex A.

In compliance with USAID’s environmental regulations, an Initial Environmental Examination (IEE) document was prepared by the Combating Zika and Future Threats Grand Challenge team to identify potential risks, risk reduction measures and make decisions on compliance thresholds and conditions. Based on the results of the IEE process, an overall Negative Determination (with conditions) threshold decision was recommended for the grants and the IEE document was approved by the Bureau Environmental Officer (BEO) on September 27, 2016. However, upon further discussion and review of the proposed research activities, seven of the 26 grants were identified as needing further evaluation due to the use of experimental pesticides and techniques. The Wolbachia-based strategy grant awarded to MU was identified as one of the grants requiring additional information to better understand the risks associated with the project prior to commencing activities. As a result, the IEE document was amended on April 13, 2017 to assign a Positive Determination threshold decision and commence the scoping process, which is a preliminary environmental review that is conducted to determine the scope of the impacts to be addressed in an Environmental Assessment (EA).

This document was prepared to identify significant and non-significant human health and environmental impacts related to the proposed activities and determine if an EA is needed based on the impacts identified. It also provides additional information on the Wolbachia-based strategy project activities, including existing conditions, geographic scope, applicable environmental regulations and permit requirements, feasible alternatives, and monitoring controls that will be in place to minimize risks.

1 WHO Zika Virus Fact Sheet (6 September 2016) http://www.who.int/mediacentre/factsheets/zika/en/

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1.2 PROJECT PURPOSE

The purpose of this project is to develop a novel, sustainable, and cost-effective approach to combating Zika and other arboviruses such as dengue and chikungunya. This approach involves the controlled release of Aedes aegypti mosquitoes infected with Wolbachia to introduce the bacterium to the population of wild Ae. aegypti mosquitoes that transmit viruses. Wolbachia has been shown to reduce the replication of Zika and other viruses in the mosquito vector, which blocks the ability of the mosquito to transmit the viruses to people. The long-term goal of the project is for the wild population of Ae. aegypti to be replaced with Wolbachia-infected Ae. aegypti.

This same approach has been used to undertake large-scale field trials in Australia, Indonesia, Vietnam and Brazil and represent a paradigm shift in arboviral disease control. This is an innovative technological approach that may provide a sustainable and long-term intervention tool for communities affected by arboviral diseases, and reduces risks from exposure to insecticides used for traditional vector control.

1.3 SCOPING STATEMENT OBJECTIVE

The primary objective of the scoping process was to identify significant and non-significant health and environmental impacts related to the proposed activities and determine if an EA is needed based on the impacts identified. The scoping process is triggered when a Positive Determination threshold decision has been made due to potentially significant or unknown environmental impacts from a proposed action (22 CFR 216.3(a)(4)), which requires that a preliminary environmental review be conducted to determine the scope of the impacts to be addressed in the EA.

During the IEE review process, it was determined that this project would be assigned a Positive Determination due to the unknown human health and environmental impacts associated with the Wolbachia-based strategy for Zika vector control and that further information would be needed to better understand the risks prior to confirming if an EA is required. This SS serves as the scope of work for justifying the Positive Determination or changing the recommended threshold to a Negative Determination with Conditions, if significant impacts on the environment are not identified.

As required by USAID’s environmental regulations (22 CFR 216), the Scoping Team focused on the following items during the scoping process:

x Review sources of information and available data relevant to the proposed activities

x Identify significant environmental issues that require further review in the form of an EA, if needed. This includes identifying significant issues that have emerged during implementation of similar interventions and approaches in other countries over the past several years.

x Identify non-significant environmental issues that do not need to be addressed in an EA

x Identify environmental, human health and other benefits of the proposed activities

x Identify other feasible alternative activities to reduce Zika infection

x If an EA is required, provide a schedule and methodology for the preparation of the EA

The Scoping Team included two scientists from the Cloudburst-Tellevate team, under the GEMS II contract. Their names and qualifications are provided in Annex B.

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1.4 SCOPING METHODOLOGY

The scoping activities for the SS were conducted between February and May 2017 and involved reviewing relevant documents and information related to the project activities and environmental impacts. Consultation activities were also conducted with key stakeholders, including USAID staff, EDP and PECET researchers, host country government officials, community relations workers and affected residents. The Scoping Team also visited the insectary where mosquitoes are raised, an International Organization for Standardization(ISO) 9001-certified laboratory, and two release sites where field trials were recently completed or are currently underway (the Paris and La Madera Comunas in the city of Bello). A detailed description of the methodologies used to accomplish the scoping activities is provided below.

1.4.1 RESEARCH AND LITERATURE REVIEW

Prior to consultation activities, a research and literature review was conducted to identify relevant documents and information that would justify the environmental analysis and threshold decision recommendation. This included reviewing similar Wolbachia experimental studies that have been performed in the U.S and other countries to assess potential risks. While most of the literature and information were provided by EDP and PECET, the Scoping Team also conducted an independent search on the Internet to identify other relevant documents. In addition, the Scoping Team reviewed project background documentation, including MU’s Concept Note2 submitted to USAID for the Combating Zika and Future Threats: A Grand Challenge for Development initiative, as well as environmental compliance information provided to USAID in November 2016. A full list of the documents and information that were collected and reviewed as part of the scoping process is provided in the References section (Section 10).

1.4.2 STAKEHOLDER CONSULTATIONS AND SITE VISIT

As part of the scoping process, the Scoping Team consulted key stakeholders to solicit feedback and identify potentially significant issues related to the project. Consultations were conducted during the site visit in April 2017 and included USAID staff, EDP and PECET researchers, host country government officials, community relations workers, and affected residents. A list of participants is included in Annex C.

Prior to the site visit, initial feedback was solicited via email from USAID and EDP to obtain relevant background information, identify key stakeholders to interview, and determine potential risks that should be evaluated during the scoping process. All identified stakeholders were invited to assist. In addition, a pre-site visit conference call was held on April 21, 2017 with USAID, EDP, and PECET staff to discuss the upcoming site visit and consultations with key stakeholders.

Consultation activities were conducted in Medellín between April 24 and April 27, 2017 and consisted of individual or group interviews with key stakeholders. Most interviews with local government officials, community relations workers, and affected residents were conducted in the local language (i.e. Spanish) and translated by the Scoping Team. A copy of the site visit agenda is provided in Annex D.

2 Monash University (2016) Pilot deployment of Wolbachia technology to reduce transmission of Aedes aegypti-borne diseases, including Zika, dengue and chikungunya in Medellín, Colombia

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2. EXISTING CONDITIONS According to the Pan American Health Organization (PAHO), 48 countries and territories in the Americas have confirmed local, vector-borne transmission of Zika since 20153. Colombia had the highest number of Zika cases after Brazil, with a total of 19,817 pregnant women reported with suspected Zika in the country from the beginning of the outbreak to early February 20174. While the number of cases of Zika and other vector-borne diseases such as dengue and chikungunya have been lower in 2017 compared to 2016, the spread of these diseases continues to be a major public health concern.

Government officials in Colombia have taken preventative measures to minimize the transmission of Zika, dengue, and chikungunya using educational initiatives and vector control interventions. Educational initiatives are conducted to inform the public on how to protect themselves from mosquito bites and reduce the number of mosquito breeding sites around homes. One of the challenges is that some local homes are open, without screening on doors or windows, which increases the risks of mosquito bites. Also, many homes have open containers that catch rainwater and are not continually emptied, making it difficult to fully eliminate mosquito breeding sites.

Vector control interventions typically involve the use of adulticides and/or larvicides to help reduce the number of mosquitoes in an area. This includes using truck foggers to spray insecticides through communities during peak mosquito seasons, which is a common practice in areas with high cases of vector-borne diseases. However, this is often ineffective at controlling enough mosquitoes to measurably reduce the incidence of these diseases. In addition, it only takes one virus-carrying female mosquito to infect an entire family in a household. Thus, even if mosquito control activities reduce the mosquito population, viral infection rates may remain high. As a result, the government and public are often left with few resources for effectively managing mosquitoes and virus transmission. This Wolbachia-based strategy provides a long-term solution for effectively managing the vector and transmission of diseases.

3 PAHO Regional Zika Epidemiological Update (Americas) April 27, 2017 http://www.paho.org/hq/index.php?option=com_content&id=11599&Itemid=41691 4 Zika – Epidemiological Report Colombia March 2, 2017 http://www2.paho.org/hq/index.php?option=com_docman&task=doc_view&gid=35139&Itemid=270&lang=en

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3. DESCRIPTION OF PROJECT ACTIVITIES The proposed project will involve the large-scale release of Ae. aegypti mosquitoes containing Wolbachia as a novel intervention strategy to control the transmission of Zika and other mosquito-borne diseases such as dengue, and chikungunya. Both male and female Wolbachia-infected mosquitoes will be released to successfully establish Wolbachia in 27 Comunas within the cities of Bello and Medellín. Specifically, a multi-phased approach will be implemented during the field trials, as shown in Figure 1.

Figure 1. Multi-Phased Approach for the Release of Wolbachia-Infected Mosquitoes

In 2015, EDP successfully executed a pilot study in a part of the Comuna of Paris to evaluate the effectiveness of the Wolbachia-based deployment approach. Wolbachia-infected mosquitoes were released for a period of 21 weeks with the last release occurring on December 17, 2015. Since then, monitoring activities have been conducted every week and results have shown that there is still an increase in Wolbachia within the Comuna of Paris, proving that mosquitoes with the bacteria are progressively becoming established and replacing the wild uninfected Aedes mosquitoes, without further releases.

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Based on the success of this pilot study and implementation of the technology in other countries, EDP will continue to expand into the remaining areas of Paris and La Madera Comunas in Bello (Phase 1). Following Phase 1, the research team will develop the capacity and infrastructure to undertake the larger-scale release of Wolbachia-infected mosquitos (Phase 2A). Once the capacity and infrastructure are established, the research team will further expand Wolbachia releases from the Paris and La Madera Comunas to other Comunas within Bello and Medellín.

PHASE 1: PARIS AND BELLO RELEASES (9 MONTHS)

The key objective of Phase I is to immediately expand Wolbachia releases from the existing Paris pilot study site into surrounding areas of the Paris and La Madera Comunas in Bello. During this phase, both male and female mosquitoes carrying the Wolbachia strain wMel will be released using the existing release methods and facilities at PECET. In addition, the community engagement approach established during the pilot study will be implemented to ensure community support prior to the field trials. This will allow the program to maintain its current momentum both internally within the project team as well as with key stakeholders in Colombia.

Key activities for Phase 1 will include:

x Existing regulatory approval from the Bioethics Committee of UA will be updated to include the expansion of releases into additional areas within Bello.

x Rearing capacity of the existing insectary at PECET will be expanded to produce 500,000 adult mosquitoes per week through modification of existing methods.

x Activities such as testing alternative release modalities (eggs versus adult mosquitoes), determining minimum mosquito release rates for Wolbachia establishment in local mosquito populations, and stabilizing the Wolbachia frequency in the Paris release area by immediately increasing the contiguous area will be implemented and monitored.

The research team will release Wolbachia-infected adult mosquitoes and mosquito eggs (target of 50% females and 50% males) once a week with the goal of reaching a 60% infection frequency. In order to monitor Wolbachia frequency, the research team will use Biogents (BG) traps to collect adult mosquitoes and record the number of females and males. Mosquitoes will be subjected to polymerase chain reaction (PCR) testing to detect for the continued presence of Wolbachia and determine the minimal release rate needed. In addition, ovitraps will be deployed and checked once a week to record the number of eggs per trap and their hatch rate. The types of BG traps and ovitraps that will be used during the experimental trials are shown in Figure 2 below.

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Figure 2. Types of Traps Used for Mosquito Monitoring

PHASE 2A: SCALE-UP PREPARATION (7 MONTHS)

As part of Phase 2A, the research team will develop the capacity and infrastructure to undertake the large-scale release and monitoring of Wolbachia-infected mosquitoes during Phase 2B of the project.

Key activities for Phase 2A will include:

x Establish a new PECET office in downtown Medellín with increased capacity for housing expanded administrative, laboratory and insectary operations and activities. An existing warehouse will be renovated to establish a large-scale insectary which will meet quarantine requirements and allow mass rearing of both mosquito eggs and adults for release (10 - 15 million mosquitoes per week). USAID funds will not be used to support construction-related activities.

x Recruit and train local staff for mass rearing, field operations (release and monitoring), community engagement, communication activities and disease surveillance.

x Implement robust data management systems to enter, store and retrieve project related data.

x Evaluate historical insecticide resistance data to determine whether insecticide resistance studies need to be implemented to optimize the release strain for local conditions. If this analysis indicates that resistance is a potential issue, then expanded insecticide resistance testing will be completed in mosquito populations sampled across the city.

x Customization of the Public Acceptance Model (PAM), which is EDP’s framework for broad scale community engagement initially developed and tested in Australia. Additional information on the PAM is provided below. The research team’s communications unit will also manage the engagement plan with key national stakeholders to ensure ongoing communication and support.

x Develop a detailed plan for the execution of Phase 2B releases, including identification and mapping of release sites and establishment of a mosquito field sampling program.

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x Obtain any additional regulatory approvals from the Colombian Secretaría de Salud for Phase 2B releases.

PHASE 2B: SCALE-UP DEPLOYMENT (17 MONTHS)

Following Phase 2A, the research team will further expand Wolbachia releases from the Paris and La Madera Comunas to other Comunas within Bello and Medellín. This phase involves a three-stage approach to incrementally build capacity and successfully release and monitor the Wolbachia method in each of the Comunas. Phase 2B deployments will be implemented in stages of increasing units of roughly 250,000 residents. The following number of Comunas in Bello and Medellín will be targeted at each stage:

x Stage 1 – releases across 4 Comunas (5 months) x Stage 2 – releases across an additional 9 Comunas (5 months) x Stage 3 – releases across the remaining 12 Comunas within Bello and Medellín (6 months)

Key activities in Phase 2B include:

x Three start-to-finish staged deployments with corresponding incremental capacity building across each stage.

x Recruitment and training of local staff for field operations (release and monitoring).

x Monitoring of Wolbachia establishment in field populations of mosquitoes. Depending on baseline mosquito population levels prior to the commencement of Wolbachia mosquito releases, and the duration and density of releases (usually 2.5-4.5 months), Wolbachia frequency in the mosquito population usually reaches 80% between 6-9 months after commencement of releases, and is maintained at levels generally above 90% thereafter.

x Documenting a detailed plan for future roll outs and capturing the core knowledge and expertise in an on-line learning platform (Catalyst). This plan will inform future expansion of the technology to other areas of Colombia as part of a national roll out.

The research team will release Wolbachia-infected adult mosquitoes and mosquito eggs (50% females and 50% males) each week. Once the Wolbachia infection rate in a site reaches 60% for 3 consecutive weeks, Wolbachia releases will cease and deployments will move to the next site. Both mosquito adults and larvae will be collected in the field using BG traps and ovitraps, respectively, and will be brought to the laboratory for PCR diagnosis of Wolbachia presence to monitor changes in the infection frequency. The number of mosquitoes to be released will be adjusted based on a real-time infection frequency data in a specific sub-location.

COMMUNITY ENGAGEMENT

Community engagement activities will be conducted during each phase of the project. This will include hosting meetings and campaigns with community members within each of the Comunas to provide information on the project, solicit feedback, and conduct surveys to evaluate homeowner perceptions and receive feedback from residents. EDP will rely on the PAM to evaluate community acceptance of the project prior to releases taking place and external specialist consultants will be engaged to assess the

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effectiveness of the model as a community engagement model. Core components of the PAM include the following:

x Ongoing quantitative social research to measure awareness and acceptance of the Wolbachia method.

x A campaign of awareness building with a heavy emphasis on media campaigns that leverages existing social networks.

x Establishment of an issues management system to capture, track and promptly resolve any issues, complaints or queries raised about the deployment by community members.

x Establishment of a community reference group populated by a cross section of community stakeholders who will evaluate the community engagement efforts of the program to ensure that community authorization prior to proceeding with releases.

As part of this effort, EDP and PECET are working with SOCYA, an independent non-profit organization, to collect baseline information and evaluate public acceptance before, during, and after the release of Wolbachia-infected mosquitoes. Interviews will be conducted using scripted questionnaires and will be filled-in electronically by a member of the SOCYA team and georeferenced to record the location.

Given the high public acceptance levels in the Comuna of Paris during the initial pilot study, the research team does not anticipate having issues with gaining acceptance from the public in the other Comunas. However, if the project is not accepted where upcoming releases will take place, the research team will conduct additional campaigns to help clarify any questions or concerns from the public. Members of the public will also be invited to tour the laboratory and insectary to gain a better understanding of the strategy. If acceptance is still not obtained, the research team will not release Wolbachia-infected mosquitoes in the area of concern.

In addition, the research team will be onsite during the field trials to monitor activities and track cases of infection. If any issues associated with the project arise, the project team will work with the local government officials to inform residents of the activities and provide any necessary guidance. The EDP also has a toll-free number established with 24-hour support for public questions or concerns during the project activities.

3.1 GEOGRAPHIC SCOPE

Large-scale field trials will be conducted in 27 Comunas within the cities of Bello and Medellín, which cover a total population of 2,588,369 (EDP estimates2). Bello and Medellín are located within the Aburrá Valley, which is a low valley in the Andes mountain range. A map showing the location of the release sites is provided above in Figure 1 and photographs from the site visit are provided in Figure 3. The sites were selected because of their “island-like” geographic features, which serve as effective and natural barriers to prevent mosquitoes from leaving the study areas during the trials. In addition, there is extensive surveillance data available in the area due to the recent high number of cases of Zika and dengue, which provides the research team with baseline epidemiological information.

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Figure 3. Photos from the Pilot Study Release Site in Paris

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4. APPLICABLE LAWS, REGULATIONS, AND POLICIES Prior to commencing activities, approval was required from the ethics committee at UA to ensure that project risks are minimized. Relevant project information was submitted to the university and approval was received on January 14, 2017. In addition, EDP and PECET have received positive feedback from state and local government representatives and acquired the necessary government support and approvals to release Wolbachia-infected mosquitoes during the field trials. In addition, local community organizations in Bello and Medellín have been informed of the project activities and the research team has had continuous communication with them regarding the project.

Provided below is a list of government organizations that have been engaged on the project. The organizations in bold were consulted during the scoping visit.

x Comité Autoridad Nacional de Licencias Ambientales (ANLA-EM) (http://www.anla.gov.co/)

x Comité Técnico de Investigación (IRB), Instituto Nacional de Salud (NIH-MOH)

x Concejo Municipal de Bello (http://www.concejodebello.gov.co/nv/)

x Consejo Seccional de Plaguicidas de Antioquia

x Dirección de Bosques, Biodiversidad y Servicios Ecosistémicos, Ministerio de Ambiente y Desarrollo Sostenible (www.minambiente.gov.co/)

x Secretaría de Salud Bello (http://www.bello.gov.co/)

x Secretaría de Salud y Protección Social de Antioquia (https://www.minsalud.gov.co)

x Secretaría de Salud de Medellín (https://www.medellin.gov.co)

x Secretaría del Medio Ambiente de Antioquia (http://antioquia.gov.co/index.php/secretaria-de-medio-ambiente)

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5. POTENTIAL ENVIRONMENTAL IMPACTS AND SIGNIFICANCE

5.1 DESCRIPTION OF POTENTIAL ENVIRONMENTAL IMPACTS

The Scoping Team conducted a site visit in April 2017 to identify and evaluate the potential impacts of the proposed project. A research and literature review was also conducted to gather available information related to the project. This section provides a description of the impacts identified, which are focused on environmental, public health, and socio-economic impacts. In addition, existing vector control management strategies were evaluated to determine if the release of Wolbachia-infected mosquitoes would result in negative impacts on current management practices. A discussion on management practices and impacts is provided below.

5.1.1 ENVIRONMENTAL IMPACTS

Table 1 provides a summary of potential environmental impacts identified during the scoping process. No significant environmental impacts were identified during the desk review or site visit.

Table 1. List and Description of Potential Environmental Impacts

Potential Impact Description

Horizontal transfer of Wolbachia to other invertebrates

Wolbachia bacteria are strictly intracellular, living only inside cells of their invertebrate hosts, and are transmitted vertically through the eggs from one host generation to another. While experimental tests have been conducted to assess the potential of Wolbachia to transfer horizontally to other invertebrate species, no evidence of transfer has been found5. In addition, there are other mosquito species (Culex pipiens, Ae. notoscriptus, Ae. albopictus, and Ae. fluviatilis) that are naturally infected with different strains of Wolbachia and live in the same habitat as Ae. aegypti. However, despite their close and long-term contact, the presence of Wolbachia in Ae. aegypti has not been reported.

Horizontal transfer of Wolbachia to predators when feeding on mosquito larvae or adult mosquitos

According to a recent risk assessment study in Singapore, there have been no reports of mosquito predators (e.g. fish, lizards, frogs, spiders, birds, etc.) becoming infected with Wolbachia after ingesting insects that naturally carry Wolbachia6. In addition, a study was conducted in Australia to test the potential transfer of Wolbachia using two different spider species. Results

5 Eliminate Dengue Program (2017). Assessments of risks associated with the Eliminate Dengue Program’s deployment of Wolbachia-carrying Aedes aegypti mosquitoes 6 Ching et al. (2017) How Safe is Wolbachia for Aedes Control? A risk assessment for the use of male Wolbachia-carrying Aedes aegypti for suppression of the Aedes aegypti mosquito population

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Table 1. List and Description of Potential Environmental Impacts

showed that there was no transmission of Wolbachia from mosquitoes to their spider predators.7

Horizontal transfer of Wolbachia to humans

See Table 2.

Wolbachia established in the environment, outside its intended host

Wolbachia are extremely common in the environment and naturally infect insects as well as spiders, mites, and terrestrial crustaceans6. However, Wolbachia can only survive in a host’s cells or in an artificial medium containing high amount of amino acids and other essential nutrients, which is unlikely in nature. As result, the transfer of Wolbachia outside its host and into the environment is unlikely5.

Increase in geographic distribution beyond predicted boundaries for Wolbachia-infected mosquitoes

Wolbachia-infected mosquitoes have been released in other countries since 2011 and there has been no evidence to-date of the establishment of Wolbachia outside of release areas. Therefore, it is unlikely that Wolbachia-infected mosquitoes will behave differently than wild Ae. aegypti and shift outside their natural geographical distribution.

5.1.2 PUBLIC HEALTH IMPACTS

Table 2 provides a summary of potential public health impacts identified during the scoping process. No significant public health impacts were identified during the desk review or site visit.

Table 2. List and Description of Potential Public Health Impacts

Potential Impact Description

Increase in mosquito density and nuisance biting

The density of mosquitoes will increase slightly during the period in which Wolbachia-infected female mosquitoes are being released, but it is anticipated that the population will drop back to the long-term natural density equilibrium after release activities are completed. This has been observed in other locations (e.g., Australia, Colombia, Brazil, Indonesia, Vietnam), where Wolbachia-infected female mosquitoes have been released.

In addition, the number of human biting events will only increase slightly during the release of female mosquitoes. However, because there will only be 2-3 mosquitoes per household released each week, it is not expected to have a significant impact to the public or become a nuisance.

Increase in vector Wolbachia-infected mosquitoes have lower vector competence for Zika, dengue, and other pathogens compared to wild populations due to the

7 Popovici et al. (2010). Assessing key safety concerns of a Wolbachia-based strategy to control dengue transmission by Aedes mosquitoes

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Table 2. List and Description of Potential Public Health Impacts

competence of Ae. aegypti transmission of viruses being inhibited by the Wolbachia infection. This has been observed in both laboratory conditions and Wolbachia-infected mosquitoes collected from the field three years after releases in Australia and Indonesia5. As a result, the risk of Ae. aegypti becoming more capable vectors of Zika and dengue are low.

Increase in more severe vector-borne diseases

Because Wolbachia reduces the replication of viruses in mosquitoes, it is unlikely that the evolution of a more virulent virus will occur in Wolbachia-infected mosquitoes. Therefore, the chances of Wolbachia-infected mosquitoes making Zika or dengue cases more severe than non-infected mosquitoes are low5.

Horizontal transfer of Wolbachia to humans

Although Wolbachia have not been found in humans or other mammals, humans have been exposed to Wolbachia for thousands of years through the consumption of insects and foods containing insects. Also, several experimental tests have been conducted to assess the potential transfer of Wolbachia to humans and there has been no scientific evidence to show that humans can become infected with Wolbachia either by ingesting or being bitten by insects containing Wolbachia6.

Changes in host preference or feeding behavior

Based on laboratory and field observations, there have been no changes reported in host preference or feeding behavior of Wolbachia-infected Ae. aegypti mosquitoes compared to non-infected mosquitoes5Error! Bookmark not defined..

5.1.3 SOCIO-ECONOMIC IMPACTS

Table 3 provides a summary of potential socio-economic impacts identified during the scoping process. No significant socio-economic impacts were identified during the desk review or site visit.

Table 3. List and Description of Potential Socio-Economic Impacts

Potential Impact Description

Impacts to the local economy (e.g. reduced tourism, real estate value, etc.) as a result of the study

In a risk assessment conducted in Vietnam, the economic risks associated with release of Wolbachia-infected mosquitoes were evaluated and found to be negligible8. In the Medellín, local government officials believe that deployment of this technology will promote their tourism industry due to lower concerns of mosquito bites and transmission of diseases. Thus, no significant impacts are anticipated to the area’s economy due to the release

8 Vietnam Eliminate Dengue Project (2011) Risk Assessment of the Pilot Release Aedes aegypti mosquitoes containing Wolbachia

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Table 3. List and Description of Potential Socio-Economic Impacts

of Wolbachia-infected mosquitoes.

Social or behavioral changes as a result of releasing Wolbachia-infected mosquitoes

Social and behavioral changes in people may include the reduction of preventative measures to control mosquito populations due to their misunderstanding about Wolbachia. However, homeowners will continue to be encouraged to minimize breeding sites and take the recommended measures to minimize mosquito bites.

5.1.4 VECTOR CONTROL MANAGEMENT IMPACTS

Table 4 provides a summary of potential vector control management impacts identified during the scoping process. No significant impacts were identified during the desk review or site visit.

Table 4. List and Description of Potential Vector Control Management Impacts

Potential Impact Description

Reduction in the management of mosquitoes and control strategies if Wolbachia-infected mosquitoes are released

While the reduction in disease incidence may reduce the demand for spraying or fogging, government officials will continue to implement their vector control management strategies to ensure that the public is protected.

Increase in insecticide resistance in Wolbachia-infected A. aegypti, requiring higher doses and more types of insecticides

Laboratory experiments were conducted to compare insecticide resistance between Wolbachia-infected A. aegypti and wild A. aegypti and results showed that there was no difference in insecticide resistance9.

Lack of information provided to the public

The research team has in place community relations workers that are working directly with the communities to provide information regarding the project and solicit feedback. In addition, the research team has been working with local government officials to provide information on the project so that they can assist with communicating the information with the public.

5.2 SIGNIFICANT ISSUES

No significant negative issues were identified during the scoping process that would require further assessment in the form of an EA. Results of the above environmental review showed most health and environmental risks to be negligible or low with the implementation of monitoring controls.

9 Endersby et al. (2013) Effect of Wolbachia on insecticide susceptibility in lines of Aedes aegypti

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5.3 NON-SIGNIFICANT ISSUES

Based on the analysis of direct and indirect impacts described in Section 5.1 and lack of significant negative issues that were identified during the scoping process, the Scoping Team recommends excluding the potential impacts listed above from an EA.

5.4 BENEFITS

In addition to evaluating potential environmental impacts during the scoping process, there were benefits identified, such as the potential reduction in numbers of Ae. aegypti mosquitoes and bites, lower cases of vector-borne diseases, reduced need for vector control strategies that involve the use of chemical pesticides that may cause damage to human health and the environment, promotion of innovation and self-sustaining biological control method that does not required continued releases, reduction in long-term vector control costs, and protection of the valuable tourism industry.

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6. MITIGATION AND MONITORING CONTROLS This section provides a brief description of mitigation and monitoring controls that will be implemented during the release trials in Medellín. Additional information on the mitigation and monitoring controls will be included in the Environmental Mitigation and Monitoring Plan (EMMP) that will be prepared by the Implementing Partner and submitted for this project per the GH environmental compliance process.

6.1 MOSQUITO INSECTARY AND LABORATORY CONTROLS

The ISO 9001 certified mosquito insectary and laboratory is located at PECET, which is part of the Sede de Investigación Universitaria (SIU) at the UA. Mass rearing and laboratory activities will be conducted by qualified and trained personnel from EDP and PECET. Approximately 60 laboratory and field personnel will be working on the project. Trainings will be in accordance with the Standard Operating Procedures (SOPs) and Waste Management Plan (WMP) developed by PECET, which describe the appropriate protective clothing and protocols for minimizing health and environmental impacts during project activities. This includes the proper use and disposal of general waste, chemical reagents used during the laboratory research activities, and blood used to feed female mosquitoes, which are disposed of through a third-party contractor. The SOPs (Manual de Bioseguridad, Procedimientos y Buenas Prácticas de Laboratorio), ISO 9001 certification and WMP (Plan de Gestión Integral de Residuos) are maintained on site and were available upon request. Disposal records and any incident reports will be maintained by PECET.

During the field trials, quality control procedures will be implemented to ensure the safe deployment of Wolbachia mosquitoes. Each generation within the mosquito colony will be routinely tested in the laboratory to detect for the presence of Wolbachia prior to releases. Also, mosquito fitness tests such as egg viability and fecundity, maternal transmission of Wolbachia, the presence of cytoplasmic incompatibility between infected and uninfected mosquitoes, and resistance to insecticides will be periodically undertaken at PECET. In addition, the blood used to feed the mosquito colony will be screened for pathogens to ensure its pathogen-free status.

6.2 EXPERIMENTAL FIELD TRIAL CONTROLS

Prior to commencing the releases, community engagement activities will be conducted within each of the Comunas to provide the public information on the project, solicit feedback, and conduct surveys to evaluate homeowner perceptions and receive feedback from residents. Interviews will be conducted using scripted questionnaires and will be filled-in electronically by a member of the SOCYA team and georeferenced to record the location. EDP will rely on the PAM to evaluate community acceptance of the project prior to releases taking place and external specialist consultants will be engaged to assess the effectiveness of the tool as a community engagement model.

Given the high public acceptance levels in the Comuna of Paris during the initial pilot study, the research team does not anticipate having issues with gaining acceptance from the public in other Comunas. However, if the project is not accepted where upcoming releases will take place, the research team will conduct additional campaigns to help clarify any questions or concerns from the public. Members of the public will also be invited to tour the laboratory and insectary to get a better understand of the strategy.

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If acceptance is still not obtained, the research team will not release Wolbachia-infected mosquitoes in the area of concern.

In addition, the research team will be onsite during the field trials to monitor activities and track cases of infection. If any issues associated with the project arise, the project team will work with the local government officials to inform residents of the activities and provide any necessary guidance. The EDP also has a toll-free number established with 24-hour support if there are questions or concerns during the project activities.

The mosquito population will be monitored before, during, and after the experimental trials using BG traps. A single BG trap will be placed every 250 x 250 meters inside a consenting volunteer’s residence and will be checked once a week. The BG traps come with a scented paper that attracts and lures the host-seeking female in the traps. However, this will be removed and disposed at PECET prior to deploying the BG traps due to the strong scent and potential to irritate a person’s eyes. Ovitraps will also be used to track the mosquito larvae population and checked once a week, but will only be used before and during the releases. The number of trapped mosquitoes will be recorded in the field and taken to the laboratory where they can be further analyzed and tested for Wolbachia infection.

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7. INFORMATION GAPS/SURVEYS NEEDS The Scoping Team was unable to obtain a copy of a restricted-release report of Wolbachia work in Indonesia, which was drafted by the Indonesian government. However, reports from other countries included enough information for the environmental analysis and threshold determination justification. Thus, the Indonesia report is likely to be redundant and not essential for this SS.

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8. FEASIBLE ALTERNATIVES In accordance with USAID’s environmental procedures (22 CFR 216), this section describes reasonable alternatives including the proposed action. It also briefly describes the reasons for eliminating the alternatives not included in the SS.

8.1 ALTERNATIVE 1: NO ACTION

The alternative of no action would occur if USAID decides to not continue support of this Wolbachia-based strategy, and instead relies on traditional vector control methods such as spraying pesticides to control the spread of diseases. Under this alternative, it is likely that the cases of Zika, dengue, and chikungunya diseases will remain the same or increase, which may negatively impact the public. In addition, if an increase in disease outbreaks occurs, this may negatively impact the local tourism industry, which is a major source of income for the region.

8.2 ALTERNATIVE 2: PROPOSED ACTION

The objective of the project is to provide an innovative and long-term approach to reducing the transmission of vector-borne diseases from Ae. aegypti mosquitoes. This approach will help to protect residents from becoming infected with the Zika, dengue, and chikungunya viruses and will help to reduce the need for other vector control methods such as pesticides, which may lead to adverse impacts to human health and the environment.

8.3 ALTERNATIVE 3: INCREASE USE OF PESTICIDES

This alternative involves the use of more pesticides to control the population of mosquitos, particularly in cases of outbreaks. While the local government currently uses pesticides for vector control, there are negative human health and environmental impacts associated with the use of these chemicals. In addition, local government representatives expressed their long-term goal to reduce the use of pesticides as a vector control strategy to minimize potential environmental impacts and insecticide resistance, which would lead to higher doses and use of more types of insecticides.

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9 RECOMMENDATIONS No significant negative environmental impacts were identified during the scoping process that would require further assessment in the form of an EA. Instead, the environmental analysis showed that most human health and environmental risks were negligible or low with the implementation of monitoring controls, as discussed in Section 5. Based on this information, the Scoping Team recommends amending the latest IEE dated April 13, 2017 to change the Positive Determination threshold decision to a Negative Determination with Conditions. The conditions would include the implementation of monitoring controls to minimize any potential health and environmental impacts, as described in Section 6.

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10. REFERENCES Bill and Melinda Gates Foundation (2008). Tahiti: Field Release of Wolbachia Incompatible Aedes polynesiensis Mosquitoes in French Polynesia.

Ching et al. (2017) How Safe is Wolbachia for Aedes Control? A risk assessment for the use of male Wolbachia- carrying Aedes aegypti for suppression of the Aedes aegypti mosquito population. Epidemiological News Bulletin, Vol 43 No 1.

Eliminate Dengue Program (2017). Assessments of risks associated with the Eliminate Dengue Program’s deployment of Wolbachia-carrying Aedes aegypti mosquitoes

Endersby et al. (2013) Effect of Wolbachia on insecticide susceptibility in lines of Aedes aegypti

Hurst et al. (2012) Impacts of Wolbachia Infection on Predator Prey Relationships: Evaluating Survival and Horizontal Transfer Between wMelPop Infected Aedes aegypti and Its Predators. Med. Entomol. 49(3): 624-630.

Laven H. (1967) Eradication of Culex pipiens fatigans through cytoplasmic incompatibility. Nature. 216: 383–384.

Monash University (2016) Pilot deployment of Wolbachia technology to reduce transmission of Aedes aegypti-borne diseases, including Zika, dengue and chikungunya in Medellin, Colombia

Murphy et al. (2010) Risk Analysis on the Australian release of Aedes aegypti (L.) (Diptera: Culicidae) containing Wolbachia. CSIRO

PAHO Regional Zika Epidemiological Update (Americas) April 27, 2017 http://www.paho.org/hq/index.php?option=com_content&id=11599&Itemid=41691

Popovici et al. (2010) Assessing key safety concerns of a Wolbachia-based strategy to control dengue transmission by Aedes mosquitoes Mem Inst Oswaldo Cruz, Rio de Janeiro, Vol. 105(8): 957-964, December 2010.

Secretaría de Salud (2016) Vigilancia Epidemiológica Semana 52, 2016 http://www.gob.mx/cms/uploads/attachment/file/179535/sem52.pdf

USEPA (2016) EPA Grants Extension of Experimental Use Permit for ‘Wolbachia Mosquito’ (https://www.epa.gov/pesticides/epa-grants-extension-experimental-use-permit-wolbachia-mosquito)

Vietnam Eliminate Dengue Project (2011) Risk Assessment of the Pilot Release of Aedes aegypti mosquitoes containing Wolbachia. Prof. Truong Quang Hoc, DSc. Prof. Truong UyenNinh, PhD Nguyen Van Tuat, PhD Nguyen Viet Hung, PhD Nguyen Dinh Cuong, MD. MPH.

WHO Zika Virus Fact Sheet (6 September 2016) http://www.who.int/mediacentre/factsheets/zika/en/

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ANNEX A: EDP AND PECET OVERVIEW AND COLLABORATION Monash University, as an international leader in Aedes-Wolbachia research in other countries (Australia, Indonesia, Vietnam, Brazil) through the EDP, has released Wolbachia-infected mosquitoes in over 40 sites, including large-scale city-wide releases across the northern Australian cities of Townsville and Cairns. The Program has gained regulatory approval to release Wolbachia mosquitoes, and through extensive community engagement and communication has established strong support and participation from local communities and stakeholders in all locations. Monash University collaborates with key local and international partners to provide the scientific capability for development and implementation of the Wolbachia method for dengue and Zika control. Field sites operate independently, but sit under a common scientific program umbrella allowing technology and knowledge transfer across projects by the most rapid means possible for advancement of the initiative.

The initial field releases through the EDP took place in northern Australia where Wolbachia has now persisted in local mosquito populations for more than 5 years without additional releases of mosquitoes or control activities being undertaken. There has been no evidence of any significant dengue transmission occurring in areas with high levels of Wolbachia infection, compared with reports of dengue transmission occurring in other areas where no Wolbachia infected mosquito releases have been undertaken. Similar results have been found in the field release sites in Yogyakarta, Indonesia, and the Program is currently monitoring promising results from releases in Vietnam, Brazil, and Colombia.

For the releases in Colombia, the EDP has teamed with PECET, to deploy and monitor the release of Wolbachia mosquitoes in Bello and Medellín. The EDP and PECET team plans to continue working in this role prospectively, on an annual basis, until 2025.

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ANNEX B: NAMES AND QUALIFICATIONS OF SCOPING TEAM The Scoping Team included two scientists from the Cloudburst-Tellevate Team. Their names and qualification information is provided below.

Alan Schroeder, PhD, MBA, Team Leader and Entomologist. Dr. Schroeder has over 25 years of extensive experience in disease vectors and management, chemistry, pesticide toxicology, business, and interpreting USAID environmental compliance regulations. This includes evaluating and preparing environmental documents related to pesticide and chemical threats to human health and natural resources, such as pest management plans, biosafety studies, and due diligence reports. He also has experience in conducting scenario planning to mitigate climate change impacts on food safety, food security/cash crop/livestock value/cold chains, pests and diseases, with Climate Smart crops/livestock tools. Betzy Colon, MSc, Environmental Scientist. Ms. Colon’s work experience includes developing environmental documents and conducting technical reviews to identify potential human health and environmental impacts associated with the implementation of USAID’s GH projects. Ms. Colon also has experience organizing scientific meetings and workshops to facilitate discussions among scientific experts and stakeholders. In addition, she has in-depth knowledge of the National Environmental Policy Act, Federal Insecticide, Fungicide, and Rodenticide Act, and other federal laws and regulations.

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ANNEX C: NAMES OF PARTICIPANTS Name Organization

Octavio Jimenez Concejo Municipal de Bello

Jose Serrano Concejo Municipal de Bello

Bladimir Sierra Martinez Concejo Municipal de Bello

Simon Kutcher Monash University (EDP)

Jorge Osario Monash University (EDP)

Rita Almanza Secretaría de Salud de Medellín

Erika Piedrahita Pineda Secretaría Seccional de Salud y Protección Social de Antioquia

Henry Pulido Secretaría de Salud Bello

Yesenia Carmona Hoyos Socya

Mario Marulanda Carvajal Socya

Iván Darío Vélez Bernal Universidad de Antioquia/PECET

Juan David Suaza Universidad de Antioquia/PECET

Ana Lucia Velez Henao Universidad de Antioquia/PECET

Sandra Marcela Naranjo Universidad de Antioquia/PECET

Tomas Santamaria Universidad de Antioquia/PECET

Sandra Uribe Universidad de Antioquia/PECET

Rachel Dagovitz USAID/Global Health

Marissa Leffler USAID/Global Health

Avery Waite USAID/Global Health

María Elena Santana USAID/Mexico

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ANNEX D: SITE VISIT AGENDA Site Visit Agenda Schedule: April 24 to April 27, 2017 Location: Medellín, Colombia Scoping Study Team: Alan Schroeder (Cloudburst Group) and Betzy Colon (Tellevate) Eliminate Dengue Colombia Team: Ivan Dario Velez (IV) – Team Leader Tomas Santa Maria (TS) – Project Manager Sandra Uribe (SU) – Entomology Leader Juan David Suaza (JS) – Entomology Coordinator Ana Lucia Velez (AV) – Communications and Community Engagement Leader Simon Kutcher (SK) – Project Development Manager (Eliminate Dengue Global)

DAY 1: MONDAY, APRIL 24, 2017

Time Description Participants

9:00am - 10:00am x Introductions x Purpose and objectives x Scoping study process and schedule

AS, BC, IV, TS, SU, AV, SK

10:00am - 11:00am x Review of scope of work x Preliminary findings from desk review x Other Wolbachia-related studies

AS, BC, IV, TS, SU, AV, SK

11:00am - 12:00pm x Introduction to Eliminate Dengue Colombia AS, BC, IV, TS, SU, AV, SK

12:00pm - 1:00pm Lunch

1:00pm - 2:30pm Environmental Analysis: x Potential health and environmental impacts x Significance of impacts x Mitigation measures and monitoring controls

AS, BC, TS, JS, SK

2:30pm - 2:45pm Break

2:45pm - 4:00pm x Regulatory framework x Key environmental compliance requirements x Permits and regulatory approvals

AS, BC, TS, JS, SK

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DAY 2: TUESDAY, APRIL 25, 2017

Time Description Participants

9:00am - 10:30am Tour PECET insectary and laboratories AS, BC, JS

10:30am - 4:00pm Visit field sites and tour Medellín city AS, BC, TS, SK

DAY 3: WEDNESDAY, APRIL 26, 2017

Time Description Participants

TBD Interview with Henry Pulido, Bello Health Department

AS, BC

TBD Interview with Rita Almanza, Medellín Health Department

AS, BC

TBD Interview with school teachers AS, BC

TBD Interview with members of Community Reference Group

AS, BC

TBD Interview with Tania Posada, Mi Gente Foundation AS, BC

TBD Others - TBD AS, BC

DAY 4: THURSDAY, APRIL 27, 2017

Time Description Participants

9:00am - 12:00pm x Collect additional environmental documentation, as needed

x Review findings and next steps x Wrap-up scoping study activities

AS, BC, IV, TS, SU, AV, SK