scoping statement for the large-scale release of wolbachia … · 2017-07-16 · scoping statement...

COVERSHEET

SCOPING STATEMENT FOR THE LARGE-SCALE RELEASE OF WOLBACHIA-INFECTED MOSQUITOES IN MÉRIDA, MEXICO

PROGRAM/ACTIVITY DATA Program/Activity Number AID-OAA-F-16-00082 Program/Activity Title Grant: Develop a Wolbachia-Based Strategy for Zika Vector

Control in Central and South America Country/Region Mexico/LAC USG Foreign Assistance Framework Investing in People

3.1 Health Program Period Covered October 3, 2016 – September 30, 2018 Life of Project Amount $966,711 Scoping Statement (SS) Prepared By Cloudburst-Tellevate Team under the GEMS II Contract Management Unit Contact Point Marissa Leffler Current Date June 9, 2017 Expiration Date September 30, 2018

APPROVAL OF THE ENVIRONMENTAL SCOPING STATEMENT

CLEARANCE:

_________________________________

_________________________________

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

Date

CONCURRENCE:

_________________________________

_________________________________

Rachel Dagovitz Global Health Bureau Environmental Officer

Date

7/5/17

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Typewritten Text

email clearance

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Typewritten Text

7/3/17

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 - Salvador Sánchez-Colón, Mission Environmental Officer, Mexico


June 9, 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 ...................................................................................................................................................... 2

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

1.4 Scoping Methodology ............................................................................................................................................ 3

1.4.1 Research and Literature Review ................................................................................................................. 4

1.4.2 Stakeholder Consultations and Site Visit .................................................................................................. 4

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

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

3.1 Geographic Scope .................................................................................................................................................. 8

4. Applicable Laws, Regulations, and Policies ............................................................................................................ 10

5. Potential Environmental Impacts and Significance ............................................................................................... 11

5.1 Description of Potential Environmental Impacts .......................................................................................... 11

5.1.1 Environmental Impacts ................................................................................................................................ 11

5.1.2 Public Health Impacts .................................................................................................................................. 13

5.1.3 Socio-Economic Impacts ............................................................................................................................. 14

5.1.4 Vector Control Management Impacts ..................................................................................................... 14

5.2 Significant Issues .................................................................................................................................................... 15

5.3 Non-Significant Issues .......................................................................................................................................... 15

5.4 Benefits ................................................................................................................................................................... 15

6. Mitigation and Monitoring Controls ....................................................................................................................... 16

6.1 Mosquito Insectary and Laboratory Controls ............................................................................................... 16

6.2 Experimental Field Trial Controls .................................................................................................................... 16

7. Information Gaps/Surveys Needs ............................................................................................................................ 17

8. Feasible Alternatives ................................................................................................................................................... 18

8.1 Alternative 1: No Action .................................................................................................................................... 18

8.2 Alternative 2: Proposed Action ........................................................................................................................ 18

8.3 Alternative 3: Increase Use of Pesticides ....................................................................................................... 18

9 Recommendations ....................................................................................................................................................... 19

10. References .................................................................................................................................................................. 20

Annex A: MSU Presence in Mexico and Collaboration with the State of Yucatán ......................................... 22

Annex B: Names and Qualifications of Scoping Team ............................................................................................ 23

Annex C: Names of Participants .................................................................................................................................. 24

Annex D: Site Visit Agenda ........................................................................................................................................... 25

Scoping Statement for the Large-Scale Release of Wolbachia-Infected Mosquitoes in Mérida, Mexico

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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. Michigan State University (MSU) and their research partner, the Universidad Autónoma de Yucatán (UADY), were among the awardees and their research aims to use Wolbachia as a novel intervention strategies to control the transmission of vector-borne diseases, including the Zika, dengue and chikungunya viruses. Additional information on MSU and their presence in the State of Yucatán 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 MSU 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 geographic scope, existing conditions, applicable environmental regulations and permit requirements, feasible alternatives, and monitoring controls that will be in place to minimize risks.

1.2 PROJECT PURPOSE

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

https://www.usaid.gov/grandchallenges/zika


http://gemini.info.usaid.gov/egat/envcomp/repository/pdf/49026.pdf

http://gemini.info.usaid.gov/repository/pdf/49998.pdf


http://www.who.int/mediacentre/factsheets/zika/en/


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The purpose of this project is to develop a novel and sustainable approach to combating Zika and other arboviruses such as dengue and chikungunya. This approach involves the release of Aedes aegypti mosquitoes infected with Wolbachia to reduce the population of wild Ae. aegypti mosquitoes that transmit viruses. This occurs when infected male Ae. aegypti mosquitoes mate with uninfected female Ae. aegypti mosquitoes, which induces reproductive cytoplasmic incompatibility (CI) and causes the fertilized eggs to not hatch. In addition, Wolbachia has shown to reduce the replication of Zika and other viruses in the mosquito vector.

This approach has been conducted in large-scale field trials in China and other countries, including the U.S., and represents a paradigm shift in arboviral disease control. It's an innovative, cutting edge technology that provides a sustainable, long-term intervention 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 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:

1. Review sources of information and available data relevant to the proposed activities 2. 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.

3. Identify non-significant environmental issues that do not need to be addressed in an EA 4. Identify environmental and other benefits of the proposed activities 5. Identify other feasible alternatives to reduce Zika infection 6. 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.

1.4 SCOPING METHODOLOGY

https://www.usaid.gov/our_work/environment/compliance/22cfr216#216.3


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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, MSU and UADY researchers, host country government officials, local community leaders, and affected residents. The Scoping Team also visited the insectary, laboratory, and the two release sites where field trials will be conducted in Mérida. 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 the MSU research team, 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 MSU’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 significant issues related to the project. Consultations were conducted during the site visit in April 2017 and included USAID staff, MSU and UADY researchers, host country government officials, local community leaders, 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 MSU 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 attend. In addition, a pre-site visit conference call was organized and held on April 13, 2017 to discuss the upcoming site visit and consultations with key stakeholders. Participants of the pre-site visit call included USAID and MSU staff.

Consultation activities were conducted in Mérida between April 18 and April 20, 2017 and consisted of individual or group interviews with key stakeholders. Most interviews with local government officials, local leaders, 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 Xi, Zhiyong (2016) Develop a Wolbachia-based strategy for Zika vector control in Central and South America



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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. In 2016 alone, 7,560 cases of Zika were report in Mexico by the Secretaría de Salud (Mexico)4, with 820 of those cases occurring in the Yucatán area5. 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.

The Government of Yucatán has taken preventative measures to minimize the transmission of Zika, dengue, and chikungunya in the Yucatán Peninsula through the use of 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 many local homes are open, without screening on doors or windows, which increases the chances of mosquito bites. Also, many homes have open containers that are not continually emptied, making it difficult to fully eliminate mosquito breeding sites. In addition, many of the natural repellants being purchased or made at home by locals are not always effective at repelling female Aedes mosquitoes because their ingredients do not have sufficient efficacy or durability. Repellents containing picaridin, which is an effective active ingredient against Aedes mosquitoes, are not available. There are effective repellents available such as DEET, but cost more than the natural repellents.

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 a sufficient number of 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 Secretaría de Salud (2016) Vigilancia Epidemiológica Semana 52, 2016 http://www.gob.mx/cms/uploads/attachment/file/179535/sem52.pdf 5 Milenio Novedades (2017). Yucatán Cierra 2016 con 820 casos de zika (10 January 2017) http://sipse.com/milenio/Yucatán-cierra-anio-con-820-casos-zika-238006.html

http://www.paho.org/hq/index.php?option=com_content&id=11599&Itemid=41691

http://www.gob.mx/cms/uploads/attachment/file/179535/sem52.pdf

http://sipse.com/milenio/yucatan-cierra-anio-con-820-casos-zika-238006.html


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3. DESCRIPTION OF PROJECT ACTIVITIES The proposed project will involve the 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 at two locations in Mérida to induce population suppression and replacement. Specifically, a three-phased approach will be implemented during the field trials, as shown in Figure 1.

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

Wolbachia-infected males will first be released at two locations to induce sterility and suppress the population by up to 90% (Phase I). This occurs when Wolbachia-infected male mosquitoes are released and mate with wild females who do not carry the same strain of Wolbachia, which causes the fertilized eggs not to hatch. Similar field trials were previously conducted in a village in Burma (Myanmar) and results showed that the release of incompatible males successfully eliminated a Culex mosquito vector population6. Following the suppression of the population, Wolbachia-infected females will be released to establish a virus resistant population and trigger population replacement (Phase II). Once the resistant population grows to a given density, males carrying a second Wolbachia strain will be released to maintain population suppression at over 80% (Phase III).

Prior to commencing field trials, MSU and UADY will establish a mosquito mass rearing system, collect baseline entomological data in the selected field sites, and work to gain public support through community education and stakeholder engagement. In addition, small-scale renovation construction will be undertaken to build a new mosquito mass rearing and laboratory research facility at UADY. However, USAID funds will not be used to support construction-related activities as these activities will be funded and implemented by UADY.

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


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PHASE I: POPULATION SUPPRESSION

During the population suppression phase, male adult mosquitoes carrying the Wolbachia strain wAlbB will be produced through a mass rearing system established at the UADY. The male mosquitoes will then be released three times per week at each of the two field locations. Mosquitoes may be released either inside or outside of houses, depending on the distribution of larvae habitat. Because male mosquitoes neither bite nor transmit diseases, public acceptance of male releases has been easily achieved.

The number of infected males to be released will be adjusted based on a target ratio of 5:1 (ratio of released male vs. wild male). In order to monitor this ratio, the research team will use biogents (BG) traps to collect adult mosquitoes and record the number of females and males. Individual male mosquitoes will be subjected to polymerase chain reaction (PCR) testing for diagnosis of Wolbachia to confirm the ratio of released infected males vs wild males. In addition, ovitraps will be collected every 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. The research team anticipates reaching a successful population suppression with mosquito density reduced by 90% within three months in the release sites as compared to the control sites.

Figure 2. Types of Traps Used for Mosquito Monitoring

PHASE II: POPULATION REPLACEMENT

For population replacement, the research team will release Wolbachia-infected females once every week with the goal of reaching a 40% female infection frequency, a threshold that will trigger population replacement based on the field prediction models. Female adults and mosquito 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 the infection frequency. The number of females to be released will be adjusted based on a real-time infection frequency data in a specific sub-location. Release will stop if the infection frequency reaches 60% and continues to increase even without further release. It is anticipated that population replacement activities will be completed within six months.


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PHASE III: POPULATION SUPPRESSION

Following Phase II, the research team will monitor the population density and release males carrying a second Wolbachia strain (wPip) to maintain suppression of the targeted population suppression. Specifically, male mosquitoes infected with wPip will be released as needed to maintain a >80% suppression of the modified population that carries wAlbB. As with Phases I and II, the population will be monitored through the use of BG traps and ovitraps.

COMMUNITY ENGAGEMENT

Community engagement activities will be conducted during each phase of the project. This will include hosting meetings with project communities to solicit feedback and conducting surveys to evaluate homeowner perceptions and receive feedback from residents. Individual interviews will be conducted by UADY personnel using both scripted questions and open-ended prompts to solicit feedback. Residents participating in the experimental trials will also be given a consent form to sign prior to participation and will be allowed at any stage of the experiment to withdraw from having mosquitoes released near their home. All consent forms will be translated into the local language and procedures will be established to ensure residents understand the information on the forms and provide written consent.

In addition, UADY personnel that have already been working closely with the residents at the two locations 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 community leaders to inform residents of the activities and provide any necessary guidance. The communities have also established their own social media webpages, which can be used by the research team to help communicate information related to the project.

3.1 GEOGRAPHIC SCOPE

Experimental field trials will be conducted at two locations within a residential suburb of Mérida, in the state of Yucatán in Mexico. Specifically, releases will occur in the small villages of Hacienda San Antonio Tahdzibichén (Release Site 1) and Hacienda San Pedro Chimay (Release Site 2), as shown in Figures 3 and 4. Each site is between 30-50 hectare in size with a population of 724 inhabitants at Release Site 1 and 1,241 inhabitants at Release Site 2 (2010 UADY estimates). The sites were selected because of their small size and surrounding dense vegetation, which serves as an effective and natural barrier to prevent mosquitoes from leaving the study areas during the field trials.

Two additional locations with similar environmental conditions and mosquito densities were selected as the control sites for the purpose of collecting comparative data. The control sites are less than 10 km south of Release Site #2 in the villages of Molas and Tekik de Regil. Wolbachia-infected mosquitoes will not be released at the control sites.


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Figure 3. Location of Mosquito Release and Control Sites in Mérida, Yucatán, Mexico

Figure 4. Photos from Site Visit at the Release Sites


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4. APPLICABLE LAWS, REGULATIONS, AND POLICIES Prior to commencing activities, approval is required from the ethics committee at MSU to ensure that project risks are minimized. The approval information has been submitted to the university and project activities will not commence until this final approval is received. In addition, MSU and UADY have received positive feedback from government representatives at the Secretaría de Salud (Mexico) and have acquired the necessary government permit to release Wolbachia-infected mosquitoes during the field trials. The Secretaría de Salud (Mexico) is also going to be actively engaged on the project and will assist the research team in mitigating any identified health and environmental risks.

Support from the Secretaría de Investigación Innovación y Educación Superior (SIIES) has also been received and an approval letter for the release of Wolbachia-infected mosquitoes is currently being sought from Dr. Raúl Godoy. During the site visit, it was discussed that a permit may be required from the Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (SENASICA), which is the government authority that reviews and approves permits for the release of biologicals and genetically modified organisms. However, these permits are typically required for agriculture or aquaculture activities and therefore, may not be required for this particular project. MSU will consult SENASICA to confirm if a permit is required for the release of Wolbachia-infected mosquitoes.

Other government organizations in Mexico have been informed of the proposed project activities and the research team has had continuous communication with them regarding the project.

Provided below is a list of the federal and state government organizations that have been consulted.

x Secretaría de Salud de Mexico (http://www.gob.mx/salud) x Secretaría de Salud de Yucatán (http://salud.Yucatán.gob.mx/) x Secretaría de Investigación Innovación y Educación Superior (SIIES)

(http://www.siies.Yucatán.gob.mx/) x Secretaría de Desarrollo Urbano y Medio Ambiente (SEDUMA), Yucatán

(http://www.seduma.Yucatán.gob.mx/) x Consejo Nacional de Ciencia y Tecnología (CONACYT) (http://www.conacyt.mx/)

http://www.gob.mx/salud

http://salud.yucatan.gob.mx/

http://www.siies.yucatan.gob.mx/

http://www.seduma.yucatan.gob.mx/

http://www.conacyt.mx/


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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 found7. In addition, there are other mosquito species (Culex pipiens, A. notoscriptus, A. albopictus, and A. fluviatilis) that are naturally infected with different strains of Wolbachia and live in the same habitat as A. aegypti. However, despite their close and long-term contact, the presence of Wolbachia in A. 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 Wolbachia8. In addition, a study was conducted in Australia to test the potential transfer of Wolbachia using two different spider species. Results showed that there was no transmission of Wolbachia from mosquitoes to their spider predators.9

7 Eliminate Dengue Program (2017). Assessments of risks associated with the Eliminate Dengue Program’s deployment of Wolbachia-carrying Aedes aegypti mosquitoes 8 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 9 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 1. List and Description of Potential Environmental Impacts

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 crustaceans8. 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 unlikely7.

Niche replacement by other mosquito species due to suppression of the Ae. aegypti population

In Singapore, surveillance studies have been conducted to evaluate the risk of other mosquito species such as Aedes albopictus taking over areas with low Ae. aegypti population. Despite the reduction in Ae. aegypti population in Singapore in the past few decades, scientists have not observed Aedes albopictus taking over the niche of Ae. aegypti. As a result, the ecological risks are considered to be negligible7.

Ecological imbalance due to suppression of the Ae. aegypti population

Because Ae. aegypti mosquitoes inhabit built-up human environments and have limited interaction with nature, the suppression of the Ae. aegypti population will not have a significant impact on animals that feed on mosquitoes7. In addition, this technology will target only Ae. aegypti, which accounts for a small portion of the total number of mosquito species. There are over 3,000 mosquito species in nature. Presence of those non-target species will presumably maintain the ecological balance.

Reduction in pollination of flowers

Although male mosquitoes feed on nectar, they are not known to contribute to the pollination of flowers7. Therefore, the suppression of the mosquito population will have a minimal impact on the flowering of plants.

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.


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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


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 in Phase II of the project if compared to the end of Phase I, but is still significantly lower if compared to the base line number (or natural density) or the control sites. However, because there will only be a limited number of females released, it is not expected to have a significant impact to the public or become a nuisance. Phases I and III will only involve the release of non-biting males.

Increase in vector competence of Ae. aegypti

Wolbachia-infected mosquitoes have lower vector competence for Zika, dengue, and other pathogens compared to wild populations due to the transmission of viruses being inhibited by the Wolbachia infection. This has been observed in both laboratory condition and Wolbachia-infected mosquitoes collected from the field three years after releases in Australia and Indonesia6. 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 employs multiple layers of defense mechanisms in mosquito, including immunity and metabolism, to reduce the replication of viruses with broad spectrum activity 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 low6.

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


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Table 2. List and Description of Potential Public Health Impacts

bitten by insects containing Wolbachia8.

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 mosquitoes6.

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


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 negligible10. In the State of Yucatán, 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 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


Reduction in the management of mosquitoes and control strategies if

While the reduction in disease incidence may reduce the demand for spraying or fogging, government officials will continue to implement their

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


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

Wolbachia-infected mosquitoes are released

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 resistance11.

Lack of information provided to the public

The research team has in place teams of local sociologists and anthropologists that are working directly with the two 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.

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 eventual 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, reduced need for ineffective and expensive repellents, and protection of the valuable tourism industry.

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


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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 two experimental field trials in Mérida. 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 mosquito insectary and laboratory is located at the Collaborative Unit for Entomological Bioassays (UCBE), which is part of the Campus de Ciencias Biologicas y Agropecuarias (CCBA) of the UADY. Mass rearing and laboratory activities will be conducted by qualified and trained personnel from MSU and UADY. Approximately 20 laboratory and field personnel will be working on the project. Trainings will be in accordance with the Standard Operating Procedures (SOPs) that are being developed for this project, which will describe the appropriate protective clothing and protocols for minimizing health and environmental impacts during project activities. This will include the proper use and disposal of general waste, chemical reagents used during the laboratory research activities, and animal blood (i.e., sheep blood) used to feed female mosquitoes. Disposal records and any incident reports will be maintained by UADY. The SOPs will be developed in accordance with the Mexican Secretaría de Salud and World Health Organization (WHO) guidelines.

6.2 EXPERIMENTAL FIELD TRIAL CONTROLS

Prior to commencing the field trials, residents in the two release site locations (Hacienda San Antonio Tahdzibichén and Hacienda San Pedro Chimay) will be provided a consent form to sign prior to participation and they will be allowed to withdraw from having mosquitoes released near their home at any stage of the experiment. All consent forms will be translated in the local language and procedures will be established to ensure that residents understand the information on the forms and provide written consent.

In addition, UADY personnel that have already been working closely with the residents at the two locations 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 community leaders to inform residents of the activities and provide any necessary guidance. The communities also have their own social media webpages established, which can be used by the research team to help communicate information related to the project.

The mosquito population will be monitored before, during, and after the experimental trials using BG traps and ovitraps. For every hectare, the research team will use two BG traps and one ovitrap to capture adult and larval mosquitoes and the traps will be checked every week for a period of 24 hours. 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. In addition, the research team will place mosquito BG traps and ovitraps at locations 200 and 500 meters from the border of the village release sites to monitor for any unlikely escape of released mosquitoes from the release site.


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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 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 pesticides are currently used by the local government, 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 in 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 6. 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 5.



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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. Eradication of Culex pipiens fatigans through cytoplasmic incompatibility. Nature. 1967;216:383–384

Milenio Novedades (2017). Yucatán Cierra 2016 con 820 casos de zika (10 January 2017) http://sipse.com/milenio/Yucatán-cierra-anio-con-820-casos-zika-238006.html

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/

http://sipse.com/milenio/yucatan-cierra-anio-con-820-casos-zika-238006.html

http://www.paho.org/hq/index.php?option=com_content&id=11599&Itemid=41691

http://www.gob.mx/cms/uploads/attachment/file/179535/sem52.pdf

https://www.epa.gov/pesticides/epa-grants-extension-experimental-use-permit-wolbachia-mosquito

http://www.who.int/mediacentre/factsheets/zika/en/


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Xi, Zhiyong (2016) Develop a Wolbachia-based strategy for Zika vector control in Central and South America


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ANNEX A: MSU PRESENCE IN MEXICO AND COLLABORATION WITH THE STATE OF YUCATÁN MSU, as a national leader in study abroad programs, has more than 50 years of collaboration experience with the Government of Mexico and State of Yucatán, both sending and hosting international students and scholars. For over 20 years, MSU has conducted spring break study programs in Mexico, including Mérida. In 2012, MSU’s College Osteopathic Medicine began support for the establishment of a large regional medical clinic in Mérida, including five key MSU-funded FTE staff, and the first hemodialysis unit that now serves over 2 million people for all of the Yucatán, Guatemala and Belize. More than 150 MSU pre-medical and medical students and health science undergraduates have studied in Mérida, and MSU has invested over $150K USD on the 2017 Pan-American One Health Conference to be held in Mérida.

This Wolbachia Project has received a recent MSU investment of $400,000 in the Principle Investigator’s vector control research using a three-year (7/1/2016-6/30/2019) Strategic Partnership Grant. To date, MSU has invested about $2M USD in health-related development in Mérida. Clearly, MSU has a strong stake in the health of citizens of Yucatán.

MSU, along with the collaboration with UADY, Yucatán Department of Health, O’Horan Hospital and Marista University will implement the Wolbachia-based strategy. UADY has a long history of research on mosquitoes and mosquito-borne diseases.


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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

Emilio Martínez de Velasco Aguirre CONACYT

Antonio Chi Xool Hacienda San Antonio Chimay Community Leader

Abelardo Uc Galaviz Hacienda San Antonio Tahdzibichén Community Leader

David DeWitt MSU

Joseph Haywood MSU

Rafael Marinez MSU

Zhiyong Xi MSU

Fabián Correa Morales Secretaría de Salud (Mexico)

Jorge Mendoza Secretaría de Salud (Yucatán)

Eduardo Batllori SEDUMA

Raúl Humberto Godoy Montañez SIIES

Andreas Aluja Shunerman UADY

Hugo Delfin Gonzalez UADY

Norma Pavia Ruz UADY

Javier Sosa Escalante UADY

Marco Torres Leon UADY

Josue Villegas Chim UADY

Juan Manuel Chavez Trava UADY/UCBE

Pablo Manrique Saide UADY/UCBE

Abdiel Martin Park UADY/UCBE

Rachel Dagovitz USAID/Global Health

Marissa Leffler USAID/Global Health

Avery Waite USAID/Global Health

Salvador Sánchez-Colón USAID/Mexico


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ANNEX D: SITE VISIT AGENDA Site Visit Agenda Schedule: April 18 to April 21, 2017 Location: Merida, Mexico Scoping Study Team: Alan Schroeder (Cloudburst Group) and Betzy Colon (Tellevate)

DAY 1: TUESDAY, APRIL 18, 2017

Time Description Participants

Conference Room of the Hyatt Hotel 6:00pm - 6:15pm

x Welcome and brief introduction of the Autonomous University of Yucatan (UADY) by Dr. José de Jesús Williams, Rector, UADY

x Cloudburst/Tellevate scoping study team

x UADY and MSU scientists and administrators

6:15pm - 6:30pm x Purpose and objectives x Scoping study process and schedule

6:30pm - 6:45pm x Brief presentation on the project by Dr. Zhiyong Xi, Michigan State University (MSU)

6:45pm - 7:30pm x Review of scope of work x Preliminary findings from desk review x Other Wolbachia-related studies

7:30pm - 7:45pm Break

7:45pm - 8:30pm Environmental Analysis: x Potential health and environmental impacts x Significance of impacts x Mitigation measures and monitoring controls


x UADY and MSU scientists and administrators 8:30pm - 9:00pm x Regulatory framework

x Key environmental compliance requirements x Permits and regulatory approvals

9:00pm - 10:30pm Dinner

DAY 2: WEDNESDAY, APRIL 19, 2017


8:00am - 9:30am Breakfast at hotel (on your own)

9:30am Meet in the hotel lobby for transportation

Field Visits


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10:00am - 12:00pm x Research lab x Cloudburst/Tellevate scoping study team

x Dr. Pablo Manrique-Saide

x Dr. Zhiyong Xi x Other UADY and

MSU scientists and administrators

12:00pm - 2:00pm Lunch

2:00pm - 4:00pm x Release sites x Cloudburst/Tellevate scoping study team


x Dr. Zhiyong Xi x Other UADY and

MSU scientists and administrators

DAY 3: THURSDAY, APRIL 20, 2017



8:30am Meet in the hotel lobby for transportation

Conference Room of Merida Science Park 9:00am - 9:30am Interview with Fabian Correa, Ministry of Health,

Mexico City, Mexico x Cloudburst/Tellevate

scoping study team x Dr. Pablo Manrique-

Saide x Dr. Zhiyong Xi x Interviewees

9:45am -10:15am Interview with Dr. Raul Godoy, Director of Secretaria de Investigación Innovación y Educación, Merida, Yucatan, Mexico

10:30am - 11:00am Interview with Dr. Jorge Mendoza, Director of Ministry of Health, Merida, Yucatan, Mexico

11:15am - 11:45am Interview with Dr. Eduardo Batllori, Director of Urban Development and Environment of the State of Yucatan, Mexico

12:00pm - 1:30pm Lunch

Conference Room of the Hyatt Hotel


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2:00pm - 2:45pm Group interview with the administrators of UADY, including:

x Dr. José de Jesús Williams, Rector, UADY

x Dr. Marco Torres Leon, Dean of Facultad de Medicina Veterinaria y Zootecnía of UADY



x Interviewees

3:00pm - 3:45pm Group interview with the administrators of MSU, including:

x Dr. Joseph R. Haywood, Professor and Assistant Vice President for Regulatory Affairs of MSU

x Dr. Dave Dewitt, Professor and Research Associate Dean of College of Nature Science of MSU

x Mr. Rafael Marinez (Representative of Dr. Bill Cunningham), Institute of International Health of MSU


x Dr. Zhiyong Xi x Interviewees

4:00pm - 5:00pm Interview with Community organizations TBD

DAY 4: FRIDAY, APRIL 21, 2017



Conference Room of the Hyatt Hotel 9:30am – 12:00pm x Collect additional environmental

documentation, as needed x Review findings and next steps x Wrap-up scoping study activities


x UADY and MSU scientists and administrators

scoping statement for the large-scale release of wolbachia … · 2017-07-16 · scoping statement...

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