Project/Activity Data · Web viewThis activity, as noted in the project summary, will use pesticides in a controlled, pilot study, and therefore, the procedures set forth in 216.3(b)(1)

INITIAL ENVIRONMENTAL EXAMINATIONPROJECT/ACTIVITY DATA

Project/Activity Name: PMI Housing Modification Pilot StudyGeographic Location(s) (Country/Region): Uganda/East AfricaAmendment (Yes/No), if Yes indicate # (1, 2...):

No

Implementation Start/End Date (FY or M/D/Y):

November 2019

If Amended, specify New End Date: N/ASolicitation/Contract/Award Number: XXXImplementing Partner(s): XXXBureau Tracking ID: GH 10332Tracking ID of Related RCE/IEE (if any):Tracking ID of Other, Related Analyses: Integrated Vector Management Programs for Malaria

Vector Control (Version 2017) Programmatic Environmental Assessment (PEA) https://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/integrated-vector-management-programs-for-malaria-vector-control-programmatic-environmental-assessment-2017.pdf

ORGANIZATIONAL/ADMINISTRATIVE DATA

Implementing Operating Unit(s): (e.g. Mission or Bureau or Office)

President’s Malaria Initiative (PMI)

Other Affected Operating Unit(s): Lead BEO Bureau:Funding Account(s) (if available):Original Funding Amount: If Amended, specify funding amount: If Amended, specify new funding total:Prepared by: Environmental Compliance Support Contract (ECOS),

Stella SiegelDate Prepared: November 2019

ENVIRONMENTAL COMPLIANCE REVIEW DATA

Analysis Type: ☒Initial Environmental Examination

☒ Deferral

Environmental Determination(s): ☒ Categorical Exclusion(s)☒Negative With Conditions € Positive

1USAID PMI HOUSING MODIFICATION PILOT STUDY

PMI EAVES IEE, NOVEMBER 2019

☒ Deferred (per 22CFR216.3(a)(7)(iv)

IEE Expiration Date (if different from implementation end date):

1 December 2020

Additional Analyses/Reporting Required: EMMP; CRM; EMMR; IRB Approval; PERSUAPClimate Risks Identified (#): Low ___3___ Moderate ____2__ High ______Climate Risks Addressed (#): Low ___3__ Moderate ____1__ High ______

THRESHOLD DETERMINATION AND SUMMARY OF FINDINGS

PURPOSE AND SCOPE OF THE INITIAL ENVIRONMENTAL EXAMINATION (IEE)

The purpose of this document, in accordance with Title 22, Code of Federal Regulations, Part 216 (22CFR216), is to provide a preliminary review of the reasonably foreseeable effects on the environment of the United States Agency for International Development (USAID) intervention described herein and recommend determinations and, as appropriate, conditions, for these activities. Upon approval, these determinations become affirmed, per 22CFR216 and specified conditions become mandatory obligations of implementation. This analysis also documents the results of the project/activity level Climate Risk Management (CRM) process in accordance with USAID policy.

This activity, as noted in the project summary, will use pesticides in a controlled, pilot study, and therefore, the procedures set forth in §216.3(b)(1) shall not apply to projects including assistance for procurement or use, or both, of pesticides for research or limited field evaluation purposes by or under the supervision of project personnel (see 22 CFR 216.3(b)(2)(iii), Exceptions to Pesticide Procedures). In such instances; however, USAID will ensure that the manufacturers of the pesticides provide toxicological and environmental data necessary to safeguard the health of research personnel and the quality of the local environment in which the pesticides will be used.

This IEE is developed in response to 22 CFR §216.2(e) that states that any activity involving “assistance for the procurement or use of pesticides” is not eligible for categorical exclusion described by §216.2(c)(2). As such, although this project is “controlled experimentation exclusively for the purpose of research and field evaluation which are confined to small areas and carefully monitored,” it is not eligible for the categorical exclusion to which such activities are normally eligible per 22 CFR 216.2(c)(2)(ii). Therefore, an IEE must be developed and duly approved to assign threshold determinations (negative determination, negative determination with conditions, or positive determination) to components of the project.

The IEE does not need to satisfy the requirements of the pesticide procedures at 22 CFR 216.3(b)(1), as 22 CFR 216.3(b)(2)(iii) provides an exemption from the pesticide procedures for “projects including assistance for procurement or use, or both, of pesticides for research or limited evaluation purposes by or under the supervision of project personnel.” It must, however, document, per 22 CFR 216.3(b)(2)(ii), that the “toxicological and environmental data necessary to safeguard the health of research personnel and the quality of the local environment in which the pesticides will be used” is available, and appropriately informs project design.



PROJECT/ACTIVITY SUMMARY

President’s Malaria Initiative (PMI) will be supporting a pilot study in Uganda that compares the effect of housing modifications plus piperonyl butoxide (PBO) long-lasting insecticidal treated nets (LLINs) compared to PBO LLINs alone on the incidence of clinical malaria in children ages 6-59 months.

The housing modifications include the following treatment arms: (1) full house screening (i.e., eaves, doors and windows), (2) partial house screening (i.e., eaves or ceiling), (3) eave tubes plus screening, and (4) eave ribbons.

The pilot study duration is approximately 2 years. The stages of the study are summarized here, but a detailed study protocol were developed and provided to PMI by Westercamp and Staedke (2019)1, who serve as Principal Investigators for the study. As covered by this IEE, the study includes:

● Protocol development and ethical approval;

● Sensitization of national and local stakeholders about the study

● Phase I housing modification pilot study (Study set up and material procurement and implementation)

At or near the completion of the Phase I housing modification pilot study, the PMI team will reevaluate and prepare for a Phase II cluster-randomized controlled trials (cRCTs) housing improvement implementation and surveys.

In the pilot, the four housing modifications and one control will be evaluated in both traditional and modern houses. All households will also receive PBO LLINs. The effectiveness, feasibility and acceptability of the interventions will be assessed through entomology surveys, ethnographic observations and focus group discussions (FGDs), and a costing exercise. An expert review panel will review pilot results and select 1-2 interventions to take forward into Phase II. Phase I of the study will use transfluthrin pre-treated eave ribbons in approximately 20 houses. In addition, eave tubes with inserts pre-treated with deltamethrin will be installed in 20 other houses.

During the study, prevalence of parasitaemia and prevalence for anaemia will be measured in blood of children (6-59 months). Participants will have blood collected by finger-prick for thick blood smears, haemoglobin measurement, and storage of blood and filter paper samples for future studies. Participants found to have a fever (tympanic temperature > 38.0°C) or history of fever in the previous 24 hours and a positive thick blood smear will be diagnosed with malaria and treated with artemether-lumefantrine while those with other illnesses will be treated according to local guidelines.

Additionally, for entomology surveys, mosquitoes will be collected using Center for Diseases Control (CDC) light traps and indoor and outdoor human landing catches (HLC). The HLC is the

1 Westercamp, N. and Staedke, S. 2019. Impact of housing modifications combined with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) on the malaria burden in Uganda: a cluster-randomized trial. Version 1.1, 28 Aug 2019.



standard reference method for measuring human exposure to mosquito bites. HLC exposes collectors to infectious mosquito bites.

For Phase II of the study, which will include a total of about 600 houses, hessian material (burlap) eave ribbons will be treated by technical grade transfluthrin and eave tube inserts will be treated with deltamethrin. Fitting of eave ribbons onto houses will be accomplished using nails, adhesives or hook and loop fasteners and installation of the tubes with insecticide-treated netting into the house structures will require introducing openings in the walls usually using drill tools.

ENVIRONMENTAL DETERMINATIONS

Upon approval of this document, the determinations become affirmed, per Agency regulations (22CFR216). Table 1 below summarizes the environmental determinations applicable to the specific projects/activities and sub-activities.



TABLE 1. SUMMARY OF DETERMINATIONS

ACTION Categorical Exclusion Citation (if applicable)

Negative Determinatio

nPositive

Determination Deferral

ACTION 1: Study preparation

Sub-action 1.1: Develop protocol

X

§216.2(c)(2)(iii) Analyses, studies, academic or research workshops and

meetings

§216.2(c)(2)(viii) Programs involving nutrition, health care or population and family planning services except to the

extent designed to include activities directly affecting the environment (such as

construction of facilities, water supply systems, waste water treatment, etc.)

Sub-action 1.2: Gain ethical approvals

§216.2(c)(2)(v) Document and information transfers




Sub-action 1.3: Register trial with Uganda authorities and obtain permits




Sub-action 1.4: Hire and train staff, not including hands on practical training

§216.2(c)(2)(ii) Controlled experimentation exclusively for the purpose of research and field evaluation which are confined to small

areas and carefully monitored

Action 2: Sensitization of stakeholders

Sub-action 2.1: Meetings and discussions for obtaining consent

§216.2(c)(2)(iii) Analyses, studies, academic or research workshops and

meetings

Action 3: Implementation Phase ISub-action 3.1: Pilot §216.2(c)(2)(iii) Analyses, studies,



Phase ethnographic study, focus group discussions (FGD), recruitment of subjects, qualitative evaluations and studies, qualitative data analysis, expert review meetings

academic or research workshops and meetings

Sub-action 3.2: Distribution of PBO LLINs

X

§216.3 (a)(2)(iii) and §216.3(b)

Sub-action 3.3: Entomological surveys including staff training

X

§216.3 (a)(2)(iii)Sub-action 3.4. Mosquito collection using Center for Diseases Control (CDC) light traps and indoor and outdoor human landing catches (HLCs).

X

§216.3 (a) (2)(iii)

Sub-action 3.5: Blood testing, laboratory analyses and malaria treatment

X

§216.3 (a) (2)(iii)

Sub-action 3.6: Procurement of pretreated eave ribbons and tube inserts

X

§216.3(b)

Sub-action 3.7: House modification including attaching eave ribbons and drilling for installation of eave tubes

X

§216.3 (a)(2)(iii)

Action 4: Implementation Phase IITO BE ENUMERATED VIA AMENDMENT

X*

*22 CFR 216.3(b)(2)(iii), Exceptions to Pesticide Procedures states “the procedures set forth in §216.3 (b)(1) shall not apply to projects including assistance for procurement or use, or both, of pesticides for research or limited field evaluation purposes by or under the supervision of project personnel. In such instances, however, USAID will ensure that the manufacturers of the pesticides provide toxicological and environmental data necessary to safeguard the health of research personnel and the quality of the local environment in which the pesticides will be used.”

CLIMATE RISK MANAGEMENT

The climate risk management (CRM) screening for the above set of activities concluded that all activities are low risk, except the installation of the modifications, which is moderate risk.



Nonetheless, the implementing partner (IP) is advised to consider the impact of irregular rainfalls and temperature variability on project timing and results.

CONDITIONS OF APPROVAL

The PMI Housing Modification Pilot Study addressed by this IEE is recommended for a NEGATIVE DETERMINATION subject to the following CONDITIONS specific to this study:

Specific Conditions1. Exception to pesticide procedures and Phase II deferral. Per 22 CFR 216.3(b)(2)

(iii), Exceptions to Pesticide Procedures, the procedures set forth in §216.3 (b)(1) shall not apply to projects including assistance for procurement or use, or both, of pesticides for research or limited field evaluation purposes by or under the supervision of project personnel. In such instances, however, USAID will ensure that the manufacturers of the pesticides provide toxicological and environmental data necessary to safeguard the health of research personnel and the quality of the local environment in which the pesticides will be used. As noted, this IEE meets those requirements through Phase I implementation. However, pesticide use in Phase II (direct use of pesticides for treatment of eave ribbons and eave tube inserts) is deferred due to the size of the cRCTs, and as such this IEE will be amended as needed to comply with Ugandan law and in accordance with USAID 22 CFR 216.3(b)(2)(iii) regulations and be updated as necessary to fill gaps and strengthen environmental compliance based on lessons learned from the pilot implementation. Namely, the deferral will be amended by including insecticides used in Phase II in a Pesticide Evaluation Report Safer Use Action Plan (PERSUAP).

2. Use of pesticide pre-treated items only in Phase I of the study. Eave ribbons and tubes used in the housing modification pilot study will be delivered for the trial pretreated, so no pesticide treatment will be applied at the test site. No pesticide treatment of eave ribbons and tubes will be undertaken in Phase I of the study. All staff and subjects of the study will be instructed regarding proper safety measures. Approvals for use of transfluthrin pretreated materials must be obtained from the government of Uganda.

3. Full implementation of study protocols. The IP, with technical oversight from Global Health’s PMI, shall ensure full implementation of the most recent and approved study protocol and medical monitoring and reporting protocols, including the exclusion criteria pertaining to participants and workers (See Westercamp and Staedke, 2019).

4. Protocol changes require prior GH Bureau Environmental Officer (BEO) approval. Changes to the study protocol and/or medical monitoring protocol will require GH BEO review and approval PRIOR to implementation. The BEO may determine that such changes require amendment to this IEE or reconsideration of this threshold determination.

5. Completed and approved Institutional Review Board (IRB) review of the attached study protocol, by the appropriate agency(ies), must be provided to the GH BEO



PRIOR to initiation of trial with human subjects. If provided subsequent to the signature of this IEE, the IRB review will be incorporated as an IEE attachment post-signature.

6. Host country approval for pesticides used in both phases. Uganda pesticides registration, importation, sale, use and disposal are controlled and regulated by the “The Control of Agricultural Chemicals” Act. Uganda Agricultural Chemicals Board established by the Act provides oversight to testing, registration and/or de-registration of newly introduced and/or old pesticides on the market. In accordance with the Act, “No person shall carry out or cause to be carried out any laboratory tests, experiments or field trials in respect of agricultural chemicals, unless he or she has a temporary certificate issued by the board for the purpose under this regulation.” Phase II approvals by the Ugandan Agriculture Chemicals Board for pesticides may be verified at the time the deferral is rectified.

7. Personal Protective Equipment (PPE) and training, as appropriate must be provided

to workers handling, installing or removing eave ribbons or tubes treated with transfluthrin and deltamethrin with PBO.

8. Health facility awareness and preparation. All health facilities/clinics within and

nearby the study area shall be made fully aware of the project PMI Housing Modification Pilot Study activities in case residents approach them with symptoms and/or adverse side events.

9. Materials Disposition/Disposal. USAID GH staff and the IP will provide environmentally-sound solutions for the end-of-life management of eave ribbons and tubes treated with transfluthrin, in consultation with USAID BEO and the items manufacturer. Until a resolution has been reached, unused or used ribbons that are made from burlap (hessian) fabric used in cRCTs will be disposed by incineration in accordance with the manufacturer’s disposal instructions. Plastic tubes that require disposal will be recycled or properly disposed of at a landfill. Disposal protocol will be addressed prior to the conclusion of the trial and written instructions and any worker health and safety issues surrounding disposal will be developed. If a more sustainable solution than incineration is reached regarding end of life management of ribbons and tubes, then all signatories of this IEE will be notified and the IEE will be amended to reflect the new course of action.

10. Waste from provision of malaria testing and treatment (i.e., sharps, infectious waste, pharmaceuticals) generated during the study by blood collection through finger prick, heel stick, or venipuncture must follow Uganda medical waste guidelines, but should not be less stringent than what is identified in the following sources:

USAID Sector Environmental Guidelines: Healthcare Waste https://www.usaid.gov/environmental-procedures/sectoral-environmental-social-best-practices/sector-environmental-guidelines-resources#hw

World Health Organization (WHO) Safe Management of Wastes from Health-Care Activities



https://apps.who.int/iris/bitstream/handle/10665/85349/9789241548564_eng.pdf;jsessionid=6C8E914539E457680078EC17BEF5FA54?sequence=1, and

WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies, www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf .

11. Laboratory waste, particularly reagents, must be handled according to standardized Uganda laboratory waste protocols. However, these protocols should not be less stringent than what is identified in the Environmental Guidelines for Healthcare Waste as stipulated above. (https://www.usaid.gov/sites/default/files/documents/1860/SectorEnvironmentalGuidelines_Healthcare_Waste_2015.pdf.

GENERAL CONDITIONS

1. IP Compliance briefing compliance required by implementation documents. The A/COR and/or the cognizant environmental officer(s) (e.g., Mission Environment Officer [MEO], Regional Environmental Advisor [REA], BEO) will provide this IPs(s) with a copy of this IEE and brief the IP(s) on their environmental compliance responsibilities.

2. Workplans and Budgeting: The Agreement/Contracting Officer’s Representative (A/COR) will ensure the IP integrates environmental compliance requirements in work plans and budgets to comply with requirements, including Environmental Mitigation and Monitoring Plan (EMMP) implementation and monitoring.

3. Staffing: The A/COR, in coordination with the IP, will ensure all awardees have staffing capacity to implement environmental compliance requirements.

4. Records Management: The A/COR will maintain environmental compliance documents in the official project/activity file and upload records to the designated USAID environmental compliance database system.

5. Host Country Environmental Compliance: The A/COR will ensure the IP complies with applicable and appropriate host country environmental requirements unless otherwise directed in writing by USAID. However, in the case of a conflict between the host country and USAID requirements, the more stringent shall govern.

6. Work Plan Review: The A/COR will ensure the IP verifies, at least annually or when activities are added or modified, that activities remain with the scope of the IEE. Activities outside of the scope of the IEE cannot be implemented until the IEE is amended.

7. IEE Amendment: If new activities are introduced or other changes to the scope of this IEE occur, an IEE Amendment will be required.

8. USAID Monitoring Oversight: The A/COR or designee, with the support of the cognizant environmental officer(s) (e.g., MEO, REA, BEO), will ensure monitoring of compliance with established requirements (e.g., by desktop reviews, site visits, etc.).



9. EMMP: Environmental Compliance Mitigation and Monitoring Plan: The draft EMMP is attached to this IEE. The A/COR will ensure the IP completes, obtains approval for, and implements EMMPs that are responsive to the stipulated environmental compliance requirements.

10. EMMR: Environmental Mitigation and Monitoring Report (EMMR)- Compliance Reporting: The A/COR will ensure the IP includes environmental compliance in regular project/activity reports, using indicators as appropriate; develops and submits the Environmental Mitigation and Monitoring Reports (EMMRs); and completes and submits a Record of Compliance (RoC) describing their implementation of EMMP requirements in conjunction with the final EMMR or at the close of sub activities (as applicable).

A copy of each EMMR and the RoC will be provided to the GH BEO to document compliance with the conditions of this IEE. The EMMR is due on November 1 of each year for reporting on activities in the previous year.

And where required by Bureaus or Missions, ensure the IP prepares a closeout plan consistent with contract documentation for A/COR review and approval that outlines responsibilities for end-of-project operation, the transition of other operational responsibilities, and final EMMR with lessons learned.

11. Corrective Action: When noncompliance or unforeseen impacts are identified, IPs notify the A/COR, place a hold on activities, take corrective action, and report on the effectiveness of corrective actions. The A/COR initiates the corrective action process and ensures the IP completes and documents their activities. Where required by Bureaus or Missions, ensure Record of Compliance is completed.

AGENCY CONDITIONS

1. Other Supplemental Analyses: The A/COR will ensure supplemental environmental analyses that are called for in the IEE are completed and documented.

2. Resolution of Deferrals: The A/COR will ensure that the appropriate 22CFR216 environmental analysis and documentation is completed and approved by the BEO before the subject activities deferred in this IEE are implemented.

3. Compliance with human subject research requirements. The A/COR, in consultation with the BEO for the Global Health Bureau, shall assure that the IP demonstrate completion of all requirements for ethics review and adequate medical monitoring of human subjects who participate in research trials carried out through this agreement. Research activities will be registered with the Ugandan National Council for Science and Technology (UNCST) and obtain a UNCST research registration permits as necessary.

The GH BEO may request copies of documentation from the A/COR to demonstrate compliance with applicable requirements of human subject trials. All documentation demonstrating completion of required review and approval human subject trials must be in place prior to initiating any trials and cover the period of performance of the trial as described in the research protocol.



IMPLEMENTATION

In accordance with 22CFR216 and Agency policy, the conditions and requirements of this document become mandatory upon approval. This includes the relevant limitations, conditions and requirements in this document as stated in Sections 5 of the IEE and any BEO Specified Conditions of Approval.



USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATIONPROJECT/ACTIVITY NAME: PMI HOUSING MODIFICATION PILOT STUDY

Bureau Tracking ID: _____GH 10332_________________

Approval:Paul Mahanna, Office Director, GH/HIDN Date

Clearance:Julie Wallace, Malaria Division Chief Date

Date

Clearance:Jessica Okui, Uganda Mission Environmental Officer Date

Clearance:Dennis Durbin, Climate Integration Lead Date

Concurrence:Dennis Durbin, Global Health Bureau Environmental Officer Date

Concurrence:Brian Hirsch, Africa Bureau Environmental Officer Date

DISTRIBUTION: [Distribution lists may be customized by Bureau or Mission. Please follow Bureau- or Mission-specific guidance.]

PROJECT/ACTIVITY NAME: PMI HOUSING MODIFICATION PILOT STUDY Bureau Tracking ID: ____GH 10332__________________



Table of conents

Purpose and Scope of the Initial Environmental Examination (IEE) ii

Project/Activity Summary ii

Environmental Determinations iii

Climate Risk Management vii

Conditions of Approval vii

Agency Conditions x

Implementation xi

USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATION xiiTable of Contents xiiAcronyms 11.0 PROJECT/ACTIVITY DESCRIPTION 31.1 Purpose and Scope of IEE 3

1.2 Activity Overview 3

1.3 Activity Description 3

2.0 BASELINE ENVIRONMENTAL INFORMATION 52.1 Locations Affected and Environmental Context (Environment, Physical, Climate, Social) 5

2.2 Applicable and Appropriate Partner Country and Other International Standards (e.g. WHO), Environmental and Social Laws, Policies, and Regulations 8

2.3 Country/Ministry/Municipality Environmental Capacity Analysis (as Appropriate) 10

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK 114.0 ENVIRONMENTAL DETERMINATIONS 134.1 Recommended Environmental Determinations 13

4.2 Climate Risk Management 15

5.0 CONDITIONS AND MITIGATION MEASURES 205.1 Specific Conditions 20

5.2 General Conditions 22

5.3 Agency Conditions 23

5.4 Mitigation Measures 24

6.0 LIMITATIONS OF THIS INITIAL ENVIRONMENTAL EXAMINATION 257.0 REVISIONS 25ATTACHMENTS: 27



Attachment 1. Transfluthrin Toxicological Information 27

Attachment 2: DRAFT EMMP PMI Housing Modification Pilot Study 31



ACRONYMS22CFR216 Title 22 Code of Federal Regulations Part 216ACTs artemisinin-based combination therapiesADS Automated Directives SystemA/COR Agreement/Contracting Officer’s RepresentativeBEO Bureau Environmental OfficerBw body weightCAS Chemical Abstract Service CASRN Chemical Abstract Service RegistryCDC Center for Diseases ControlcRCTs cluster-randomized controlled trialsCRM Climate Risk ManagementEMMP Environmental Monitoring and Mitigation PlanEMMR Environmental Monitoring and Mitigation ReportEPA Environmental Protection Agency (US)FAA Foreign Assistance ActFGD focus group discussionGH Global Health HLC human landing catchIEE Initial Environmental ExaminationIP implementing partnerIPCS International Program on Chemical SafetyIPTp intermittent preventive treatment for pregnant womenIRB Institutional Review BoardIRS indoor residual sprayingISO International Standards OrganizationITN insecticidal-treated netIUPAC International Union of Pure and Applied ChemistryLC lethal concentrationLD lethal doseLLIN long-lasting insecticidal treated netsMOH Ministry of HealthNMCP National Malaria Control ProgramNOEL no observed effect levelPBO piperonyl butoxidePEA Programmatic Environmental AssessmentPERSUAP Pesticide Evaluation Report Safer Use Action PlanPMI President’s Malaria InitiativePPE personal protective equipmentRDT Rapid Diagnostics TestROC Record of ComplianceUBOS Uganda Bureau of StatisticsUNCST Uganda National Council for Science and TechnologyUSAID United States Agency for International DevelopmentWHO World Health Organization



1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE AND SCOPE OF IEE

The purpose of this document, in accordance with Title 22, Code of Federal Regulations, Part 216 (22CFR216), is to provide a preliminary review of the reasonably foreseeable effects on the environment of the United States Agency for International Development (USAID) intervention described herein and recommend determinations and, as appropriate, conditions, for these activities. Upon approval, these determinations become affirmed, per 22CFR216 and specified conditions become mandatory obligations of implementation. This Initial Environmental Examination (IEE) also documents the results of the project/activity level Climate Risk Management (CRM) process in accordance with USAID policy (specifically, Automated Directives System [ADS] 201mal).2

This IEE is a critical element of USAID’s mandatory environmental review and compliance process meant to achieve environmentally sound activity design and implementation. Potential environmental impacts should be addressed through formal environmental mitigation and monitoring plans (EMMPs) and/or Environmental Assessments, if needed.

1.2 ACTIVITY OVERVIEW

In sub-Saharan Africa, where up to 80–100 percent of malaria transmission occurs indoors at night, the home can be a place of high risk. Simple changes to prevent house entry by mosquitos can provide protection from malaria, making housing modification a promising strategy to address the need for long-term, non-chemically driven interventions.

President’s Malaria Initiative (PMI) will be supporting a pilot study in Uganda that compares incidence of clinical malaria in children ages 6–59 months. The aim of the study is to demonstrate that housing modifications (combined with piperonyl butoxide long-lasting insecticidal treated nets [PBO LLINs]) can reduce the malaria burden in Uganda. The primary objective, as stated by the study protocol: “To evaluate the effect of housing modifications + PBO LLINs, compared to PBO LLINs alone, on the incidence of clinical malaria in Ugandan children aged 6-59 months”.3 The hypothesis that the incidence of clinical malaria will be lower in children residing in intervention clusters (villages randomized to receive housing modifications plus PBO LLINs), than those residing in control clusters (villages randomized to receive only PBO LLINs) will be tested by researchers.

1.3 ACTIVITY DESCRIPTION

The study duration is approximately 2 years. The stages of the study include study preparation that includes protocol development and ethical approval, sensitization of national and local stakeholders about the study, setting up of the study and procurement of the necessary materials. Implementation of Phase I of the study will include ethnographic fieldwork, formative

2 USAID. 2017. ADS 201mal Climate Risk Management for USAID Projects and Activities. Available at: https://www.usaid.gov/ads/policy/200/201mal 3 Westercamp and Staedke, 2019. See previous reference.



research and focus group discussions, recruitment for the pilot, entomological surveys and implementation of interventions in 40 houses. Housing modification interventions being tested here include the installation of eaves ribbons pretreated in 20 houses and eave tubes pretreated with deltamethrin in another 20 houses. The treatment arms are: (1) full house screening (eaves, doors and windows), (2) partial house screening (eaves or ceiling), (3) eave tubes plus screening, and (4) eave ribbons. Phase II of the project will implement cluster-randomized controlled trials (cRCTs), data analysis and dissemination of results. As documented in section 4.0, Phase II is deferred in the entirety until this IEE is amended with additional mitigation measures as informed by the Phase I study and with an amendment to the Uganda Mission Pesticide Evaluation Report Safer Use Action Plan (PERSUAP) or a new PERSUAP.

Bed nets treated with pyrethroid insecticides will be included in the study as they are an effective way to reduce malaria transmission and have been deployed across Africa. However, mosquitoes that spread malaria are now developing resistance to this type of insecticide. One way to overcome this resistance is to add PBO, a synergist, to the net. PBO is not an insecticide but blocks the substance (an enzyme) inside the mosquito that enables pyrethroid resistance. Pyrethroid-PBO nets are more effective than standard pyrethroid-only nets in areas where the mosquito populations are resistant to pyrethroid insecticides.

TABLE 2: ENTAILED ACTIONS

Action 1: Study preparation


Sub-action 1.2 Gain ethical approvals


Sub-action 1.4: Hire and train staff, not including hands on practical training

Action 2: Sensitization of stakeholders

Sub-action 2.1: Meetings and discussions for obtaining consent.

The project will build awareness, secure commitment, and encourage participation from stakeholders at the national and local levels. Informed consent will be obtained. Meetings of stakeholders will be held. Documentation for informed consent for participation in all stages of the pilot will be developed and maintained

Action 3: Implementation of Phase I

Sub-action 3.1: Pilot Phase ethnographic study, focus group discussions (FGD), recruitment of subjects, qualitative evaluations and studies, qualitative data analysis, expert review meetings


Sub-action 3.3: Entomological surveys including staff training.

Sub-action 3.4. Mosquito collection using Center for Diseases Control (CDC) light traps and indoor and outdoor human landing catches (HLCs).




Sub-action 3.6: Procurement of transfluthrin pretreated eave ribbons and tube inserts

Sub-action 3.7: House modification including attaching eave ribbons and drilling for installation of eave tubes, installation of eave tubes

Action 4: Implementation of Phase II

Sub-action 4.1: cRCT Phase planning and preparations, enumeration and mapping, baseline surveys, selection of study subjects, surveys, qualitative and economic data analysis and evaluations.

Sub-action 4.2: Procurement and use of pesticides for treatment of eave ribbons and eave tube inserts, including staff training in application of pesticides






2.0 BASELINE ENVIRONMENTAL INFORMATION

2.1 Locations Affected and Environmental Context (Environment, Physical, Climate, Social)

The Study Site: East Central region of Uganda, targeting Jinja, Kayunga, Kamuli, Kaliro, Iganga, Mayuge, Namayingo, Busia ( Figure 1). High levels of parasitaemia and insecticide resistance have been documented in this area.

FIGURE 1. STUDY LOCATIONS.

Malaria vector in Uganda. The geographic distribution of malaria depends on climate. The favorable climate of Uganda allows stable, year-round malaria transmission with relatively little seasonal variability in most areas. Uganda climate is ideal for the Anopheles mosquitoes that transmit malaria parasites Plasmodium falciparum. Anopheles thrive in Uganda’s warm temperatures, humid conditions, and high rainfall. At temperatures above 20°C (68°F) the parasite Plasmodium falciparum are able to complete the growth cycle in the mosquitoes to be transmitted.4

The most common malaria vectors in Uganda are Anopheles gambiae s.I. and A. funestus, with A. gambiae s.l. being the dominant species in most locations5. A. funestus appears with frequency in high altitude areas and during the short dry seasons, when permanent water

4 National Center for Atmospheric Research and University Corporation for Atmospheric Research; Center for Science Education: Climate Change and Vector Borne Disease: https://scied.ucar.edu/longcontent/climate-change-and-vector-borne-disease



bodies are the most common breeding sites. In some areas of northern Uganda, A. funestus is the most common vector. Within the A. gambiae complex, the predominantly anthropophilic (preferring humans to other mammals) A.gambiae s.s. is by far most common. Anopheles gambiae s.s. and A. funestus are both highly endophagic (feeding indoors) and endophilic (resting indoors), making insecticidal-treated nets (ITNs) and indoor residual spraying (IRS) or other indoor vector control strategies preferable vector control strategies in Uganda.”6

Malaria endemicity. Malaria is highly endemic in ~95 percent of the country, representing ~90 percent of the population of ~33 million (Figure 2). In 2001-2002, some of the highest recorded entomological inoculation rates (infective mosquito bites per person year) in the world has been seen in Uganda, particularly in Apac and Tororo Districts.”7

The Uganda Bureau of Statistics (UBOS) has conducted the Uganda Demographic and Health Survey in years 1988/89, 1995, 2000-01, 2006 and 2011, 2016 and 2018-19 under the Uganda Bureau of Statistics Act 1998. The 2018-19 Uganda Malaria Indicator Survey was implemented by the National Malaria Control Division and the UBOS. Financial support for the survey was provided by the USAID through PMI, by the United Kingdom Department for International Development, and by the Government of Uganda with Global Fund support. Specific objectives are to measure the extent of ownership and use of mosquito bednets; measure the extent of indoor residual spraying; assess coverage of intermittent preventive treatment to protect pregnant women; identify practices and specific medications used for treating malaria among children under age 5; measure indicators of behavior change communication messages, knowledge, and practices about malaria; and measure the prevalence of malaria and anemia among children age 0-59 months.8

The surveys have shown steady improvements. Results of most recent surveys indicated that prevalence of malaria in children have decreased from 54.9 percent in 2009 to 31.7 percent in 2015 as measured by Rapid Diagnostic Tests (RDTs), and from 44.7 to 20 percent as measured by microscopy. The June 2019 survey has shown further improvement in the National Average with estimation of malaria parasite estimation through microscopy of 9.1 percent with Karamoja at 34.3 percent, West Nile 21.8 percent and Busoga 21.1 percent. Southern districts of Uganda are affected at lower rates with Kampala showing the lowest prevalence at 0.2 percent.

5 Okello PE, Van Bortel W, Byaruhanga AM, Correwyn A, Roelants P, Talisuna A, D'Alessandro U, Coosemans M. Variation in malaria transmission intensity in seven sites throughout Uganda. Am J Trop Med Hyg. 2006;75:219–225.6 ibid7 Adoke Yeka, Anne Gasasira, Arthur Mpimbaza, Jane Achan, Joaniter Nankabirwa, Sam Nsobya, Sarah G. Staedke, Martin J. Donnelly, Fred Wabwire-Mangen, Ambrose Talisuna, Grant Dorsey, Moses R. Kamya, and Philip J. Rosenthal. Malaria in Uganda: challenges to control on the long road to elimination. I. Epidemiology and current control efforts; Acta Trop. 2012 Mar; 121(3): 184–195. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3156969/8Uganda Malaria Indicator Survey 2018-19. Available at https://dhsprogram.com/pubs/pdf/PR119/PR119.pdf



FIGURE 2. MALARIA ENDEMICITY IN UGANDA IN 20069

2.2 Applicable and Appropriate Partner Country and Other International Standards (e.g. WHO), Environmental and Social Laws, Policies, and Regulations

The National Malaria Control Program (NMCP). The Ministry of Health of Uganda implements the NMCP with the objective to provide quality assured services for malaria prevention and treatment to all people in Uganda.10 USAID, through PMI, supports the Government of Uganda at different levels of the health system based on need, NMCP priorities, and geographic coverage by other donors and partners, in order to ensure complementarity and greatest impact.

President’s Malaria Initiative (PMI). PMI was launched in 2005, led by USAID, and implemented jointly with the US CDC with the goal of reducing malaria-related mortality by 50 percent across 15 high-burden countries in sub-Saharan Africa through rapid scale-up of four malaria prevention and treatment measures: ITNs; IRS; accurate diagnosis and prompt

9 Okello PE, Van Bortel W, Byaruhanga AM, Correwyn A, Roelants P, Talisuna A, D'Alessandro U, Coosemans M. Variation in malaria transmission intensity in seven sites throughout Uganda. Am J Trop Med Hyg. 2006;75:219–225.10 Ministry of Health, Republic of Uganda. Available at: https://health.go.ug/programs/national-malaria-control-program .



treatment with artemisinin-based combination therapies (ACTs); and intermittent preventive treatment for pregnant women (IPTp). PMI started supporting IRS program in Uganda in 2006. The IRS program was developed in consultation with the Ministry of Health (MoH), the NMCP and other national and international partners involved in malaria prevention and control in the country.

Uganda Malaria Reduction Strategic Plan. Uganda’s efforts against malaria are guided by the Uganda Malaria Reduction Strategic Plan for 2014–2020, which calls for a rapid and synchronized nationwide scale-up of cost-effective interventions to achieve universal coverage of malaria prevention and treatment.11 Through implementation of this plan, the NMCP aims to control malaria such that it is no longer the major cause of illness and death in Uganda. Principal among the plan strategies are integrated vector management, effective diagnosis and treatment, prevention of malaria in pregnancy, and attention to malaria epidemics.

The original policy for IPTp with sulfadoxine-pyrimethamine once during the second and third trimesters for pregnant women was adopted in Uganda in 1998. IPTp is administered as part of an integrated package of care through antenatal clinics, with directly observed treatment.

Effective case management of uncomplicated malaria and incorporating prompt and appropriate treatment with affordable, effective, and safe antimalarials, remains a cornerstone of malaria control in Uganda. In more severe cases, a priority is early recognition of the signs and symptoms of severe disease that should lead to emergency care, including parenteral therapy, in an in-patient setting. Intravenous quinine remains the recommended treatment for severe malaria in Uganda.

Long-lasting ITNs are the main preventive strategy used in Uganda. Inclusion of IRS in control programs was reinitiated in Uganda, after a gap of about 40 years, in 2006. The NMCP strategy for IRS, supported by PMI, has emphasized implementation in epidemic-prone areas, high transmission settings, and high-risk situations, such as camps for internally displaced persons or refugees. IRS has been applied in both highly endemic and epidemic-prone areas, but coverage has been incomplete. More recently, attention has moved from epidemic-prone areas to those with very high transmission intensity in central and northern Uganda.

The IRS spray rounds were conducted biannually with a pyrethroid insecticide (alpha-cypermethrin) from 2006 to 2010 before shifting to a carbamate (bendiocarb) in 2010 due to the emergence of widespread pyrethroid resistance. DDT was sprayed in Apac and Oyam districts in March to April 2008 but its use was curtailed by a court injunction and development of resistance. In 2016, there was a shift to an organophosphate insecticide (pirimiphos methyl) due to development of resistance to bendiocarb. Pirimiphos methyl is currently still in use.

Vector Exclusion Research. Malaria prevention and control remains an important U.S. foreign assistance priority. USAID works closely with the Ugandan government to strengthen their capacity to prevent and treat the disease. PMI has been integral to supporting studies that address priorities for malaria prevention and control in Uganda, and is currently contributing to studies that will help the NMCP and other decision-makers develop transition strategies to maintain gains and prevent a malaria upsurge when transitioning from IRS.

11 PMI. Uganda, Malaria Operational Plan FY 2019: https://www.pmi.gov/docs/default-source/default-document-library/malaria-operational-plans/fy19/fy-2019-uganda-malaria-operational-plan.pdf?sfvrsn=3



This PMI pilot is repurposing house screening interventions to provide sustainable, cost-effective options to IRS for vector exclusion in households. It builds on earlier studies on vector exclusion research published in the Malaria Journal in 2018, e.g.: “Semi-field studies to better understand the impact of eave tubes on mosquito mortality and behavior”12 and “Eave ribbons treated with the spatial repellent, transfluthrin, can effectively protect against indoor-biting and outdoor-biting malaria mosquitoes”13 and “Eave ribbons treated with transfluthrin can protect both users and non-users against malaria vectors”14. For other studies see the Innovative Vector Control Consortium January 2019 Technical Update.15

Research involving humans as research participants in Uganda. Oversight of research involving humans as research participants in Uganda is done first at the organizational level by Research Ethics Committees and second at the national level by the Uganda National Council for Science and Technology (UNCST) in collaboration with Uganda National Health Research Organization for health research. UNCST liaises with the Research Secretariat in the office of the President on national security issues in respect of research conducted in Uganda. An additional requirement with regard to clinical trials is for the researcher to obtain a certificate from the National Drug Authority in respect of a trial drug/device preferably prior to review of the research protocol (or proposal) by a Research Ethics Committee and registration of the protocol with UNCST.16

2.3 Country/Ministry/Municipality Environmental Capacity Analysis (as Appropriate)

Malaria remains a significant burden for Uganda, with extremely high transmission intensity in much of the country, very high prevalence of infection and incidence of disease in most areas, and substantial mortality and eradication efforts in the most endemic areas of Uganda still face obstacles because of a host of factors.

Because Uganda has some of the highest recorded measures of malaria transmission intensity in the world, complete malaria elimination is very challenging and even advances in control are very challenging in some regions. Among the issues are:

● Inadequate health resources

● Weak public health system

● Inadequate understanding of malaria epidemiology

● Inadequate understanding of the impact and optimal use of interventions

12 Barreaux et al. Malar J (2018) 17:306. Available at: https://doi.org/10.1186/s12936-018-2457-4

13 Arnold S. Mmbando, Halfan Ngowo, Alex Limwagu, Masoud Kilalangongono, Khamis Kifungo & Fredros O. Okumu. Eave ribbons treated with the spatial repellent, transfluthrin, can effectively protect against indoor-biting and outdoor-biting malaria mosquitoes; Malaria Journal volume 17, Article number: 368 (2018) https://malariajournal.biomedcentral.com/articles/10.1186/s12936-018-2520-1

14 Mwanga EP, Mmbando AS, Mrosso PC, Stica C, Mapua SA, Finda MF, Kifungo K, Kafwenji A, Monroe AC, Ogoma SB, Ngowo HS, Okumu FO.

. Eave ribbons treated with transfluthrin can protect both users and non-users against malaria vectors; Malar J. 2019 Sep 18;18(1):314. doi: 10.1186/s12936-019-2958-9. Available at: https://www.ncbi.nlm.nih.gov/pubmed/3153373915 IVCC News. Available at: http://www.ivcc.com/ngenirs/news-and-media/news/tech-updates 16 UNCST National Guidelines for Research involving Humans as Research Participant: Available at: https://www.swarthmore.edu/sites/default/files/assets/documents/institutional-review-board/Human_Subjects_Protection_Guidelines_July_2014.pdf



● Increasing resistance of parasites to drugs and of mosquitoes to insecticides

● Inappropriate case management including delays in seeking treatment

● Lack of diagnostic tests

● Lack of access to ACTs

● Inadequate utilization of drugs in malaria prevention

● Inadequate epidemic preparedness and response.

Case reporting is inadequate, and districts are often unable to implement epidemic control recommendations due to limitations in resources and availability of supplies, including diagnostics and drugs.17 The campaign to sensitize and encourage people to use mosquito nets has achieved some positive results.18

17 ibid18 New Vision. Access 26 November 2019 at: https://www.newvision.co.ug/new_vision/news/1423973/malaria-leading-cause-death-uganda



3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK19

This is human-subjects research involving the provision of different types of malaria protection to different arms of the study (i.e. groups of participants)—and thus differential risks of contracting malaria to different study arms. The study protocol, which includes provision of mosquito control to some participants, and the exclusion of certain participant groups, and informed consent, was designed to address these risks and the entailed ethical issues. These risks and ethical issues are accordingly not addressed in this IEE, except that the analysis in this section necessarily assumes and is contingent on Institutional Review Board (IRB) approval.

Other risks and potential adverse impacts on human health and the environment of the cRCT are listed below. The toxicological profile for transfluthrin is provided in Attachment 1.

ACTION 1: Study preparationSub-action Potential environmental and social impactsSub-action 1.1: Develop protocol No potential significant environmental or social impactsSub-action 1.2: Gain ethical approvalsSub-action 1.3: Register trial with Uganda authorities and obtain permitsSub-action 1.4: Hire and train staff, not including hands on practical training

ACTION 2: Sensitization of stakeholdersSub-action Potential environmental and social impactsSub-action 2.1: Meetings and discussions for obtaining consent

No potential significant environmental or social impacts

ACTION 3: Implementation of Phase ISub-action Potential environmental and social impactsSub-action 3.1: Pilot Phase ethnographic study, focus group discussions (FGD), recruitment of subjects, qualitative evaluations and studies, qualitative data analysis, expert review meetings

No potential significant environmental or social impacts


Potential indirect adverse impact on aquatic organisms if the net is inappropriately washed and/or used for fishing. Potential health impacts from exposure to LLIN pyrethroid which may produce tingling sensation on the skin as a result of direct contact. PBO synergist is low to very low in toxicity if eaten, inhaled, or touched.


Entomological surveys may require use of liquid killing agents that are volatile and flammable. A variety of reagents are used in entomological surveys including Ethyl acetate, Chloroform, Alcohol, Ammonia water, Benzene, Carbon tetrachloride, acid, Trichloro-

19 Includes analysis of environmental and social risks



ethylene and Tetrachloroethane.20 Exposure to these reagents if protective is not appropriately used in the laboratory could lead to skin sensitization. Additionally, inappropriate disposal of these reagents can contaminate waterways.

Sub-action 3.4. Mosquito collection using Center for Diseases Control light traps and indoor and outdoor HLCs.

Use of CDC light traps will not have significant impact on the environment. However, indoor and outdoor human landing catches place individuals at risk of transmission of malaria.


All children with fever or history of fever will be tested for malaria and treated appropriately prescribed artemether lumefantrine for uncomplicated cases as recommended as the first-line treatment in Uganda and in accordance with protocol. Protocols are established for more complicated cases (see Westercamp and Staedke 2019). This testing and treatment can lead to generation of hazardous and non-hazardous medical waste.


Transfluthrin repellent pesticide pretreated eave ribbons and pretreated eave tube inserts will be procured for the Phase I Pilot activity. Eave ribbons are 15 cm-wide triple-layered hessian fabrics (burlap-line fabric woven from sisal fibers, procured locally). Risks associated with use of pesticides including adverse impacts on human health and environmental pollution.


Risks associated with small scale construction including injuries, generation of waste and air, water, and soil pollution and noise. Fitting eave ribbons onto houses using nails, adhesives or hook and loop fasteners (e.g., Velcro®) and installation of the tubes with insecticide-treated netting into the house structure.

ACTION 4: Implementation of Phase IISub-action Potential environmental and social impactsSub-action 4.1-4.5: Implementation of Phase II

A full analysis of environmental impacts for Phase II are deferred. Phase II impacts will be similar for the same steps in Phase I noted above; however, cumulative effects of the cluster trials may increase the magnitude of the impact in a given community. For Phase II of the project, the eave ribbons will be treated by study staff. Ribbons will be first washed thoroughly using a liquid detergent to remove any impurities. After drying, the ribbons will be treated with transfluthrin up to a dose of 5 percent. Eave tube inserts will be treated with Deltamethrin PBO.

20 Chemical and Laboratory Safety Manual, University of Georgia 2016, Available at http://research.uga.edu/docs/units/safety/manuals/Chemical-Laboratory-Safety-Manual.pdf



4.0 ENVIRONMENTAL DETERMINATIONS

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS

The following table presents the recommended determinations based on the environmental analysis conducted. Upon approval, these determinations become affirmed, per 22CFR216. Specified conditions, detailed in Section 5, become mandatory obligations of implementation, per ADS 204.

TABLE 3: ENVIRONMENTAL DETERMINATIONS

ACTION Categorical Exclusion Citation (if applicable)

Negative Determination

Positive Determination Deferral

ACTION 1: Study preparation


X

§216.2(c)(2)(iii) Analyses, studies, academic or research

workshops and meetings

§216.2(c)(2)(viii) Programs involving nutrition, health care

or population and family planning services except to the

extent designed to include activities directly affecting the

environment (such as construction of facilities, water supply systems, waste water

treatment, etc.)

Sub-action 1.2: Gain ethical approvals

§216.2(c)(2)(v) Document and information transfers





treatment, etc.)






treatment, etc.)Sub-action 1.4: Hire and train staff, not including hands on

§216.2(c)(2)(ii) Controlled experimentation exclusively for

the purpose of research and



practical trainingfield evaluation which are

confined to small areas and carefully monitored

Action 2: Sensitization of stakeholdersSub-action 2.1: Meetings and discussions for obtaining consent



Action 3: Implementation Phase I

Sub-action 3.1: Pilot Phase ethnographic study, FGD, recruitment of subjects, qualitative evaluations and studies, qualitative data analysis, expert review meetings




X

§216.3 (a)(2)(iii) and §216.3(b)


X

§216.3 (a)(2)(iii)Sub-action 3.4. Mosquito collection using CDC light traps and indoor and outdoor HLCs.

X

§216.3 (a) (2)(iii)


X

§216.3 (a) (2)(iii)


X

§216.3(b)

Sub-action 3.7: House modification including attaching eave ribbons and drilling for installation of eave tubes

X

§216.3 (a)(2)(iii)

Action 4: Implementation Phase II

TO BE ENUMERATED VIA AMENDMENT X*

*22 CFR 216.3(b)(2)(iii), Exceptions to Pesticide Procedures states “the procedures set forth in §216.3 (b)(1) shall not apply to projects including assistance for procurement or use, or both, of pesticides for research or limited field evaluation purposes by or under the supervision of project personnel. In such instances, however, USAID will ensure that the manufacturers of the pesticides provide toxicological and environmental data necessary to safeguard the health of research personnel and the quality of the local environment in which the pesticides will be used.”



As noted, this IEE meets those requirements through Phase I implementation. However, pesticide use in Phase II (direct use of pesticides for treatment of eave ribbons and eave tube inserts) does not qualify for the exception and must be deferred due to the size of the cRCTs.

4.2 CLIMATE RISK MANAGEMENT

The purpose of this CRM screening is to identify climate related risks to make the activity more resilient to both future and current climate variability and change. This screening is required per the Mandatory Reference for ADS Chapter 201: Climate Risks Management for USAID Projects and Activities.21 The activity design team identified expected climate risks to successful implementation over the life of the PMI Housing Modification Pilot Study below.

In general, climate plays an important role in the seasonal pattern or temporal distribution of diseases that are carried and transmitted through vectors because the vector animals often thrive in particular climate conditions. Warm and wet environments are generally conducive for breeding malaria vector mosquitoes. Mosquito breeding is influenced by a variety of factors such as precipitation, temperature, altitude, the mosquito life cycle, and patterns of water availability. Climate change may lead to an increase in malaria in certain spots around the world. But in other places, it may have little or no impact on the mosquito-borne disease. Temperature and precipitation changes driven by climate change are not the only factors influencing malaria transmission. Other factors include government programs to prevent transmission, preparedness for outbreaks, population size, and acquired immunity levels among populations, and those vary from nation to nation and region to region. There is a complex interplay between various factors.

In some locations, climate change is expected to produce wetter weather—which could help mosquitoes breed—but that temperatures are also predicted to increase, which could harm mosquitoes. In essence, these two effects could cancel each other out, resulting in either similar or even decreased levels of malaria in parts of Africa.22 However, with the change in weather patterns, the malaria season may shift from its traditional dates, and therefore, catch health centers and communities off-guard as they tend to take greater precaution during the “malaria season.”

Some studies indicate that future climate might become more suitable for malaria transmission in the tropical highland regions. However, other important socioeconomic factors such as land use change, population growth and urbanization, migration changes, and economic development will have to be accounted for in further details for future risk assessments. Despite the strong connection between malaria and climate, there is still quite a bit of uncertainty about future malaria transmission rates worldwide mainly because there are many other factors that affect the spread of the disease including socioeconomic development, drug resistance, and immunity.

Climate change may affect populations’ nutrition. However, according to research, the relationship between malaria and undernutrition is controversial and complex. Synergistic

21 USAID. 2017. ADS 201mal Climate Risk Management for USAID Projects and Activities. Available at: https://www.usaid.gov/ads/policy/200/201mal

22 Harvard School of Public Health, Assessing the Impact of Climate Change on Malaria. Available at: https://www.hsph.harvard.edu/news/features/climate-change-malaria/ .



associations between malnutrition and malaria morbidity and mortality have been suggested, as well as undernutrition being protective against infection, while other studies found no association.23

According to some research, “While climate is an important factor, there are social and behavioral factor that have impact on malaria. It is the behavior of individuals and groups that determines how or whether efforts to prevent or treat malaria will be successful. To attain high rates of acceptance or use of a given control method, attention must be paid to a number of important considerations: (1) local perceptions of malaria and its causes, (2) the manner in which people decide whether a given treatment or preventive measure is efficacious, (3) patterns of treatment-seeking behavior during episodes of malaria, and (4) the role that the community as a whole plays in planning, implementing, and evaluating the control program.”24

Mosquitoes have four distinctive life stages, with the first three stages being spent in the water. All mosquitoes must have water to complete their life cycle. Mosquitoes rest in tall grass, weeds, and brush near inhabited locations such as homes and other buildings. Mosquitoes breed in stagnant, standing fresh water oftentimes found around the home. Standing water around wells, pumps, cooking and washing places in villages water is left standing.

While the association of climate risks for malaria prevalence is an important note, climate risks are also tied to the key sub-activities such as modification of the housing itself, damage to the housing structures, movement of the treated tubes and eave ribbons to the site, and potential interference with the sensitization process is access to the site is constrained. With increased erratic rainfall leading to flood events or high winds, the structures used for the study could potentially be damaged. Storm events may damage the hung ribbons and result in a greater need for repair. Road networks used to transport study materials to the site and to access communities for sensitization could also be damaged and lead to delays. Most of these risks can be managed, but they must be noted for consideration and inclusion in the design of the activity.

23 Márcia Almeida Araújo Alexandre, Silvana Gomes Benzecry, Andre Machado Siqueira, Sheila Vitor-Silva, Gisely Cardoso Melo, Wuelton Marcelo Monteiro, Heitor Pons Leite, Marcus Vinícius Guimarães Lacerda, And Maria Das Graças Costa Alecrim. ”The Association Between Nutritional Status And Malaria In Children From A Rural Community In The Amazonian Region: A Longitudinal Study;” Plos Negl Trop Dis. 2015 Apr; 9(4): E0003743.:https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4415998/

24 Malaria: Obstacles And Opportunities. Chapter 12. Social And Behavioral Aspects Of Malaria; Institute Of Medicine (US) Committee For The Study On Malaria Prevention And Control; Oaks, SC Jr., VS Mitchell, GW Pearson, et al., Editors. Washington (Dc): National Academies Press (Us); 1991. https://www.ncbi.nlm.nih.gov/books/nbk234325/



TABLE 5. ACTIVITY CLIMATE RISK MANAGEMENT SUMMARY

Tasks/Defined or Illustrative Interventions

Climate Risks Risk Rating How Risks are Addressed Opportunities to Strengthen Climate Resilience

Action 1.1-1.4: Study preparation

No climate risks Not Applicable Not Applicable Not Applicable

Action 2.1: Sensitization of stakeholders

Limited access to communities due to damaged infrastructure.

Low Several efforts to sensitize the community are conducted, and therefore, minor damage is unlikely to delay or prevent significant progress with the activity.

Leverage the potential increase in malaria prevalence or transmission as a tool for promoting acceptance of the modifications through urgency.

Sub-action 3.1: Planning and FGDs, data analysis


No climate risks Not Applicable Not Applicable Not Applicable



Sub-action 3.4. Mosquito collection using CDC light traps and indoor and outdoor HLCs.

Distribution of LLINs and outdoor surveys may be restricted by extreme weather or consecutive days of intense storms, which make it difficult to travel or conduct activities outside.

Low The activity staff is in close contact with the community and can alter the dates of distribution or surveys as necessary.

None identified


Movement of equipment and treatment of the eave ribbons and inserts may be restricted by extreme weather or consecutive days of intense storms, which make it difficult to travel or conduct activities outside.

Low Procurement and pesticide treatment can be altered so they are conducted outside of the rainy season and be in place for the pilot.

None identified

Sub-action 3.7: House modification including attaching eave ribbons and drilling for installation of eave tubes.

Extreme weather may delay modification of the houses as installing the tubes and ribbons may be challenging in windy or wet weather.

Travel between houses may increase in duration if infrastructure is damaged by flooding.

Houses in the study may be damaged by flooding or winds.

Moderate Houses are located in the same area, thereby reducing the distance travelled.

Since the houses are existing, the risk for damage to infrastructure are accepted.

Workers can be offered a shady place to work or work hours can be modified to be outside the heat of the day.

Houses which may be exceptionally vulnerable to climate impacts could be excluded from the study (e.g., houses along a river).



Workers may become ill from high temperatures during the work day.



5.0 CONDITIONS AND MITIGATION MEASURESThe environmental determinations in this IEE are contingent upon full implementation of the conditions and mitigation measures set out in this section, as well as ADS 204 and other relevant requirements.

5.1 SPECIFIC CONDITIONS

5.1.1 Exception to pesticide procedures and Phase II deferral. Per 22 CFR 216.3(b)(2)(iii), Exceptions to Pesticide Procedures, the procedures set forth in §216.3 (b)(1) shall not apply to projects including assistance for procurement or use, or both, of pesticides for research or limited field evaluation purposes by or under the supervision of project personnel. In such instances; however, USAID will ensure that the manufacturers of the pesticides provide toxicological and environmental data necessary to safeguard the health of research personnel and the quality of the local environment in which the pesticides will be used. As noted, this IEE meets those requirements through Phase I implementation. However, pesticide use in Phase II (direct use of pesticides for treatment of eave ribbons and eave tube inserts) is deferred due to the size of the cRCTs, and as such this IEE will be amended as needed to comply with Ugandan law and in accordance with USAID 22 CFR 216.3(b)(2)(iii) regulations and be updated as necessary to fill gaps and strengthen environmental compliance based on lessons learned from the pilot implementation. Namely, the deferral will be amended by including insecticides used in Phase II in a PERSUAP.

5.1.2 Use of pesticide pre-treated items only in Phase I of the study. Eave ribbons and tubes used in the housing modification pilot study will be delivered for the trial pretreated, so no pesticide treatment will be applied at the test site. No pesticide treatment of eave ribbons and tubes will be undertaken in Phase I of the study. All staff and subjects of the study will be instructed regarding proper safety measures. Approvals for use of transfluthrin pretreated materials must be obtained from the government of Uganda.

5.1.3 Full implementation of study protocols. The IP, with technical oversight from GH’s PMI, shall ensure full implementation of the most recent and approved study protocol and medical monitoring and reporting protocols, including the exclusion criteria pertaining to participants and workers (See Westercamp and Staedke, 2019).

5.1.4 Protocol changes require prior GH BEO approval. Changes to the study protocol and/or medical monitoring protocol will require GH BEO review and approval PRIOR to implementation. The BEO may determine that such changes require amendment to this IEE or reconsideration of this threshold determination.

5.1.5 Completed and approved IRB review of the attached study protocol, by the appropriate agency(ies), must be provided to the GH BEO PRIOR to initiation of



trial with human subjects. If provided subsequent to the signature of this IEE, the IRB review will be incorporated as an IEE attachment post-signature.

5.1.6 Host country approval for pesticides used in both phases. Uganda pesticides registration, importation, sale, use and disposal are controlled and regulated by the “The Control of Agricultural Chemicals” Act. Uganda Agricultural Chemicals Board established by the Act provides oversight to testing, registration and/or de-registration of newly introduced and/or old pesticides on the market. In accordance with the Act, “No person shall carry out or cause to be carried out any laboratory tests, experiments or field trials in respect of agricultural chemicals, unless he or she has a temporary certificate issued by the board for the purpose under this regulation.” Phase II approvals by the Ugandan Agriculture Chemicals Board for pesticides may be verified at the time the deferral is rectified.

5.1.7 Personal Protective Equipment (PPE) and training, as appropriate must be provided to workers handling, installing or removing eave ribbons or tubes treated with transfluthrin and deltamethrin with PBO.

5.1.8 Health facility awareness and preparation. All health facilities/clinics within and nearby the study area shall be made fully aware of the project PMI Housing Modification Pilot Study activities in case residents approach them with symptoms and/or adverse side events.

5.1.9 Materials Disposition/Disposal. USAID Global Health staff and the IP will provide environmentally-sound solutions for the end-of-life management of eave ribbons and tubes treated with transfluthrin, in consultation with USAID BEO and the items manufacturer. Until a resolution has been reached, unused or used ribbons that are made from burlap (hessian) fabric used in cluster trials will be disposed by incineration in accordance with the manufacturer’s disposal instructions. Plastic tubes that require disposal will be recycled or properly disposed of at a landfill. Disposal protocol will be addressed prior to the conclusion of the trial and written instructions and any worker health and safety issues surrounding disposal will be developed. If a more sustainable solution than incineration is reached regarding end of life management of ribbons and tubes, then all signatories of this IEE will be notified and the IEE will be amended to reflect the new course of action.

5.1.10 Waste from provision of malaria testing and treatment (i.e., sharps, infectious waste, pharmaceuticals) generated during the study by blood collection through finger prick, heel stick, or venipuncture must follow Uganda medical waste guidelines, but should not be less stringent than what is identified in the following sources:



USAID Sector Environmental Guidelines: Healthcare Waste https://www.usaid.gov/sites/default/files/documents/1860/SectorEnvironmentalGuidelines_Healthcare_Waste_2015.pdf

World Health Organization (WHO) Safe Management of Wastes from Health-Care Activities https://apps.who.int/iris/bitstream/handle/10665/85349/9789241548564_eng.pdf;jsessionid=6C8E914539E457680078EC17BEF5FA54?sequence=1, and

WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies, www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf .

5.1.11 Laboratory waste, particularly reagents, must be handled according to standardized Uganda laboratory waste protocols. However, these protocols should not be less stringent than what is identified in the Environmental Guidelines for Healthcare Waste as stipulated above. (https://www.usaid.gov/sites/default/files/documents/1860/SectorEnvironmentalGuidelines_Healthcare_Waste_2015. pdf .

5.2 GENERAL CONDITIONS

5.2.1 IP Compliance briefing compliance required by implementation documents. The A/COR and/or the cognizant environmental officer(s) (e.g., Mission Environment Officer [MEO], Regional Environmental Advisor [REA], BEO) will provide this IP(s) with a copy of this IEE and brief the IP(s) on their environmental compliance responsibilities.

5.2.2 Workplans and Budgeting: The A/COR will ensure the IP integrates environmental compliance requirements in work plans and budgets to comply with requirements, including EMMP implementation and monitoring.

5.2.3 Staffing: The A/COR, in coordination with the IP, will ensure all awardees have staffing capacity to implement environmental compliance requirements.

5.2.4 Records Management: The A/COR will maintain environmental compliance documents in the official project/activity file and upload records to the designated USAID environmental compliance database system.

5.2.5 Host Country Environmental Compliance: The A/COR will ensure the IP complies with applicable and appropriate host country environmental requirements unless otherwise directed in writing by USAID. However, in the case of a conflict between the host country and USAID requirements, the more stringent shall govern.

5.2.6 Work Plan Review: The A/COR will ensure the IP verifies, at least annually or when activities are added or modified, that activities remain with the scope of the



IEE. Activities outside of the scope of the IEE cannot be implemented until the IEE is amended.

5.2.7 IEE Amendment: If new activities are introduced or other changes to the scope of this IEE occur, an IEE Amendment will be required.

5.2.8 USAID Monitoring Oversight: The A/COR or designee, with the support of the cognizant environmental officer(s) (e.g., MEO, REA, BEO), will ensure monitoring of compliance with established requirements (e.g., by desktop reviews, site visits, etc.).

5.2.9 EMMP: Environmental Compliance Mitigation and Monitoring Plan: The draft EMMP is attached to this IEE. The A/COR will ensure the IP completes, obtains approval for, and implements Environmental Mitigation and Monitoring Plans (EMMPs) that are responsive to the stipulated environmental compliance requirements.

5.2.10 EMMR: Environmental Mitigation and Monitoring Report (EMMR) - Compliance Reporting: The A/COR will ensure the IP includes environmental compliance in regular project/activity reports, using indicators as appropriate; develops and submits the EMMRs; and completes and submits a Record of Compliance (RoC) describing their implementation of EMMP requirements in conjunction with the final EMMR or at the close of sub activities (as applicable).

A copy of each EMMR and the RoC will be provided to the Global Health (GH) BEO to document compliance with the conditions of this IEE. The EMMR is due on November 1 of each year for reporting on activities in the previous year.

And where required by Bureaus or Missions, ensure the IP prepares a closeout plan consistent with contract documentation for A/COR review and approval that outlines responsibilities for end-of-project operation, the transition of other operational responsibilities, and final EMMR with lessons learned.

5.2.11 Corrective Action: When noncompliance or unforeseen impacts are identified, IPs notify the A/COR, place a hold on activities, take corrective action, and report on the effectiveness of corrective actions. The A/COR initiates the corrective action process and ensures the IP completes and documents their activities. Where required by Bureaus or Missions, ensure Record of Compliance is completed.

5.3 AGENCY CONDITIONS

5.3.1 Other Supplemental Analyses: The A/COR will ensure supplemental environmental analyses that are called for in the IEE are completed and documented.



5.3.2 Resolution of Deferrals: The A/COR will ensure that the appropriate 22CFR216 environmental analysis and documentation is completed and approved by the BEO before the subject activities deferred in this IEE are implemented.

5.3.3 Compliance with human subject research requirements. The AOR, in consultation with the BEO for the Global Health Bureau, shall assure that the IP demonstrate completion of all requirements for ethics review and adequate medical monitoring of human subjects who participate in research trials carried out through this agreement . Research activities will be registered with the Uganda National Council for Science and Technology (UNCST) and obtain a UNCST research registration permits as necessary.

The BEO for Global Health may request copies of documentation from the A/COR to demonstrate compliance with applicable requirements of human subject trials. All documentation demonstrating completion of required review and approval human subject trials must be in place prior to initiating any trials and cover the period of performance of the trial as described in the research protocol.

5.4 MITIGATION MEASURES

TABLE 6. SUMMARY OF MITIGATION MEASURES FOR NEGATIVE DETERMINATION WITH CONDITIONS ACTIVITIES

Action Mitigation Measure(s)Sub-action 3.2: Distribution of PBO LLINs

Use of PBO LLIN in accordance with Integrated Vector Management Programs for Malaria Vector Control (Version 2017) Programmatic Environmental Assessment (PEA).25


Where hazardous materials are used by entomology laboratories, ensure engineering controls such as ventilation and exhausts or wearing of respirators and appropriate PPE. Ensure that laboratories meet host country standards for reagent handling and disposal.

Sub-action 3.4. Mosquito collection using CDC light traps and indoor and outdoor HLCs.

Ensure human landing catch providers are regularly tested for malaria and are treated in accordance to study guidelines. Apply Sub-action 3.5 protocols and mitigation measures.


Follow best practices and WHO guidelines for drawing blood.26 Ensure proper health waste management. Follow USAID Sector Environmental Guidelines Healthcare Waste Partial Update 201527 and WHO guidance on Healthcare wastes.28

25Integrated Vector Management Programs for Malaria Vector Control (Version 2017); Programmatic Environmental Assessment. Available at: https://www.pmi.gov/docs/default-source/default-document-library/tools-curricula/integrated-vector-management-programs-for-malaria-vector-control-programmatic-environmental-assessment-2017.pdf26 WHO Guidelines on Drawing Blood. Best Practices in Phlebotomy. Available at: http://www.euro.who.int/__data/assets/pdf_file/0005/268790/WHO-guidelines-on-drawing-blood-best-practices-in-phlebotomy-Eng.pdf?ua-127 Sector Environmental Guidelines Healthcare Waste. Partial Update 2015 | Last Full Update: Prior to 2003. Available at: https://www.usaid.gov/sites/default/files/documents/1860/SectorEnvironmentalGuidelines_Healthcare_Waste_2015.pdf28 World Health Organization (WHO) Safe Management of Wastes from Health-Care Activities. Available at: https://apps.who.int/iris/bitstream/handle/10665/85349/9789241548564_eng.pdf;jsessionid=6C8E914539E457680078EC17BEF5FA54?sequence=1. WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies. Available at: www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf .




Obtain Uganda government permits for procurement. Follow WHO guidelines for pesticide treated materials. 29 Utilize only pretreated eave ribbons and tubes. Instruct staff on proper safety measures.


Ensure safety of all installers including safe use of tools and wearing appropriate PPE. Follow USAID Sector Environmental Guideline: Construction (2017).30 Ensure that health facilities have been notified of the study in case residents are presented to the facility with symptoms.

29 WHO; Publications on insecticide treated materials: guidelines. Available at: https://www.who.int/malaria/publications/insecticide_treated_materials-guidelines/en30 USAID Sector Environmental Guidelines and Resource. Available at: https://www.usaid.gov/environmental-procedures/sectoral-environmental-social-best-practices/seg-construction/pdf



6.0 LIMITATIONS OF THIS INITIAL ENVIRONMENTAL EXAMINATION The determinations recommended in this document apply only to projects/activities and sub-activities described herein. Other projects/activities that may arise must be documented in either a separate IEE, an IEE amendment if the activities are within the same project/activity, or other type of environmental compliance document and shall be subject to an environmental analysis within the appropriate documents listed above.

Other than projects/activities determined to have a Positive Threshold Determination, it is confirmed that the projects/activities described herein do not involve actions normally having a significant effect on the environment, including those described in 22CFR216.2(d).

In addition, other than actions (Action 4) determined to have a PERSUAP, it is confirmed that the projects/activities described herein do not involve any actions listed below. Any of the following actions would require additional environmental analyses and environmental determinations:

● Support project preparation, project feasibility studies, or engineering design for activities listed in §216.2(d)(1);

● Affect endangered and threatened species or their critical habitats per §216.5, Foreign Assistance Act (FAA) 118, FAA 119;

● Provide support to extractive industries (e.g. mining and quarrying) per FAA 117;

● Promote timber harvesting per FAA 117 and 118;

● Lead to new construction, reconstruction, rehabilitation, or renovation work per §216.2(b)(1);

● Support agro-processing or industrial enterprises per §216.1(b)(4);

● Provide support for regulatory permitting per §216.1(b)(2);

● Lead to privatization of industrial facilities or infrastructure with heavily polluted property per §216.1(b)(4);

● Procure or use genetically engineered organisms per §216.1(b)(1); and/or



7.0 REVISIONSPer 22CFR216.3(a)(9), when ongoing programs are revised to incorporate a change in scope or nature, a determination will be made as to whether such change may have an environmental impact not previously assessed. If so, this IEE will be amended to cover the changes. Per ADS 204, it is the responsibility of the USAID AOR to keep the MEO and BEO informed of any new information or changes in the activity that might require revision of this environmental analysis and environmental determination.



ATTACHMENTS:

ATTACHMENT 1. TRANSFLUTHRIN TOXICOLOGICAL INFORMATION

Technical Transfluthrin Toxicology Profile31

Type: Transfluthrin is a synthetic pyrethroid insecticide

Uses: Transfluthrin is a fast-acting insecticide. It is used in household and hygiene products, mainly against flying insects, such as mosquitoes and flies, but also against material pests, such as moths (Pflanzenschutz Nachrichten Bayer, Special edition, 1995, Bayer AG, Leverkusen).

Mode of action: Broad spectrum, effects insects’ presynaptic voltage gate sodium channels in nerve membrane, causing rapid knockdown

US Environmental Protection Agency (EPA) has proposed a use as an area repellent in semi-enclosed and enclosed spaces in residential settings. The proposed product is formulated as an impregnated textile passive diffusion device in garages, barns, tents, campers, and outdoor areas such as patios and porches.

Formulations: The main formulation types available are mosquito coils, aerosols and liquid vaporizers.

Identity: Common name: transfluthrin: E- International Standards Organization (ISO) (published)

Synonyms: benfluthrin (Bayer)

Chemical names International Union of Pure and Applied Chemistry (IUPAC): 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate

Chemical Abstract Service (CAS) or Chemical Abstract Service Registry Number (CASRN): (1R-trans)-(2,3,5,6-tetrafluorophenyl)methyl 3-(2,2-dichloroethenyl)- 2,2-dimethylcyclopropanecarboxylate

Isomerism: Transfluthrin is a chiral molecule. The technical material is 96,.5% the 1R trans configuration. The other isomers are considered impurities.

Molecular formula: C15H12Cl2F4O2

CAS Registry number: 118712-89-3

WHO classification: U – unlikely to present acute hazard

31 WHO Specifications and Evaluations for Public Health Pesticides: Transfluthrin: Available at: https://www.who.int/whopes/quality/Transfluthrin_eval_specs_WHO_May_2016.pdf?ua=1



Toxicology profile of transfluthrin technical material, based on acute toxicity, irritation and sensitization: Transfluthrin is of low acute toxicity in the rat, with an lethal dose (LD)50 of >5000 mg/kg body weight (bw) via each route of administration and with an acute and dermal no observed effect level (NOEL) of 100 mg/kg bw/d. The 4 h lethal concentration (LC)50 was >513 mg/m3 air for male and female rats. The only sign noted during the 14-day observation period was a slight tremor in females for 5 minutes after dosing. Transfluthrin is not a skin or eye irritant, nor a skin sensitizer.

In summary, according to WHO, technical transfluthrin is of low acute and dermal toxicity and is classified as unlikely to present acute toxicity in normal use by the International Program on Chemical Safety (IPCS). It is not a skin or eye irritant, nor a skin sensitizer.

In the EU however, Transfluthrin is currently classified as Xn; R38 (Irritating to skin); On the basis of a review of the submitted data, the classification and labelling is proposed: R22 (Harmful if swallowed).32

Toxicology profile of transfluthrin technical material based on repeated administration (sub-acute to chronic): In the rat, mortalities and body tremors were seen at 250 mg/kg/d following gavage dosing. There were no mortalities following dietary administration of up 5,000 ppm (approximately 40 mg/kg bw/d).

Transfluthrin induced a low frequency of urinary bladder adenomas/carcinomas in rats at high doses – the NOEL for non-cancer endpoints was 20 ppm, for cancer, 200 ppm, and the urinary tumors were observed at a level of 2000 ppm diet. It also induced adenomas in female mice at a high dose level. Transfluthrin had no initiating activity but was a weak promoter of carcinogenicity. Developmental studies in both the rat and rabbit provided no evidence of teratogenicity when transfluthrin was administered at doses up to 125 and 150 mg/kg bw/d, respectively. NOELs of 25 and 15 mg/kg bw/d were established for maternal toxicity in the rat and rabbit respectively. In a dietary multi-generation reproductive toxicity study in the rat, there was no evidence of teratogenicity, foetoxicity or reproductive toxicity in rats administered transfluthrin at doses up to 191 mg/kg bw/d. NOELs of 45 to 191 and 9 to 38 mg/kg bw/d were established for reproductive and parental toxicity, respectively.

Mutagenicity profile of the transfluthrin technical material based on in vitro and in vivo tests: Transfluthrin was not mutagenic in vitro in bacteria, yeast or mammalian cells with or without metabolic activation, neither was the any evidence of mutagenicity from in vivo tests on rats and mice.

Ecotoxicology profile of transfluthrin technical material: Field and laboratory tests showed that transfluthrin is of low toxicity to algae, birds and earthworms but it is highly toxic to fish and aquatic invertebrates such as daphnia.

32 EU Assessment Report: Transfluthrin. Available at: https://circabc.europa.eu/sd/a/910c7533-aba6-4a93-87c3-31c5f2b04445/Transfluthrin%20-%20PT18%20(assessment%20report%20as%20finalised%20on%2013.03.2014).pdf



EU classified transfluthrin as N; R50/53 (Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment) according to Directive (EC) 99/45.33

Labeling: EU Hazard classification & labelling requires transfluthrin products to be labeled:

Warning!

According to the harmonized classification and labelling (CLP00)34 approved by the European Union, this substance is very toxic to aquatic life, is very toxic to aquatic life with long lasting effects and causes skin irritation.35

EPA registered technical grade transfluthrin is Byothrin concentration 98.68 percent. The product signal word is Caution and is registered for formulation purposes only.

EPA Registration Number: 432-1588Company Name: BAYER ENVIRONMENTAL SCIENCEDivision Name: A DIVISION OF BAYER CROPSCIENCE LPAddress: 5000 CENTREGREEN WAY, SUITE 400City, State Zip: CARY, NC 27513First Registered Date: SEPTEMBER 28, 2018Current Status (Date): Active (SEPTEMBER 28, 2018)Restricted Use: NO

Hazards to humans and domestic animals: Caution. Harmful if swallowed or absorbed through skin. Environmental hazards: This pesticide is toxic to fish and aquatic organisms.

Byothrin label information is available at:https://www3.epa.gov/pesticides/chem_search/ppls/000432-01588-20180928.pdf

EPA allows the use of transfluthrin as an area repellent in semi-enclosed and enclosed spaces in residential settings. Transfluthrin is formulated as an impregnated textile passive diffusion device in garages, barns, tents, campers, and outdoor areas such as patios and porches.36 The EPA Registration Division requested that the Health Effects Division conduct an exposure and risk assessment for the proposed use of the new active ingredient, transfluthrin, for use in a personal insect repellent kit, a passive diffuser that volatilizes transfluthrin from a textile matrix into the air space around the device.37

33 European Commission, Report: Transfluthrin, Bayer Science 2013 Available at: https://echa.europa.eu/documents/10162/33166f3f-0bc3-d370-0ca8-5d4176df1e9134 Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) is based on the United Nations’ Globally Harmonised System (GHS) and its purpose is to ensure a high level of protection of health and the environment, as well as the free movement of substances, mixtures and articles.35 Harmonized classification, Summary of classification and labeling. Available at https://echa.europa.eu/information-on-chemicals/cl-inventory-database/-/discli/details/11810336 USEPA: Office of Children Health Protection. Environmental Health News Letter; October 2018. Available at: https://www.epa.gov/sites/production/files/2018-10/documents/ochp_newsletter_october_2018.pdf

37 Occupational and Residential Exposure Assessment for a Proposed Use of the New Active Ingredient Transfluthrin for use in a Personal Insect Repellent Kit. Available at: https://www.regulations.gov/document?d=epa-hq-opp-2016-0581-0005



ATTACHMENT 2: DRAFT EMMP PMI HOUSING MODIFICATION PILOT STUDY

[To be completed by Implementing Partner and approved by the USAID AOR]

Action/Sub-action

Identified Environmental Aspects or Impacts

Mitigation Measure(s)

Monitoring Indicator(s)

Monitoring and Reporting Frequency

Responsible Parties

Action 3: Implementation of Phase I of the studySub-action 3.2: Distribution of PBO LLINs

Potential indirect adverse impact on aquatic organisms if the net is inappropriately washed and/or used for fishing. Exposure to LLIN may produce tingling sensation on the skin as a result of direct contact with pyrethroid pesticide used to treat nets. PBO synergist is low to very low in toxicity if eaten, inhaled, or touched

Use of PBO LLIN in accordance with Integrated Vector Management Programs for Malaria Vector Control (Version 2017) PEA38

% of sampled households that are using LLINs correctly

At least one sample of households


Entomological surveys may require use of liquid killing agents that are volatile and flammable. Exposure to these reagents if protective is not appropriately used in the laboratory could lead to skin sensitization. Additionally, inappropriate disposal of these reagents can contaminate waterways.

Where hazardous materials are used by entomology laboratories, ensure engineering controls such as ventilation and exhausts or wearing of respirators and appropriate PPE.

Ensure that laboratories meet host country standards for reagent handling and disposal.

Proper engineering controls installed and operated when using hazardous materials.

Or

Laboratory staff using PPE.

ANDEntomological laboratories have waste management plans for reagents and host country permits as applicable.

At beginning of survey.

At least one unannounced visit

At beginning of survey.

Sub-action 3.4. Mosquito collection using Center for Diseases

Use of CDC light traps will not have significant impact on the environment. However, indoor and outdoor

Ensure human landing catch providers are regularly tested for malaria and are

% of human landing catch providers tested for malaria.

Monthly.

At least once

38 IVM MVC PEA. (see previous reference)



Control (CDC) light traps and indoor and outdoor human landing catches (HLCs).

human landing catches place individuals at risk of transmission of malaria.

treated in accordance to study guidelines.

Apply Sub-action 3.5 protocols and mitigation measures.

Protocol for management of medical waste and checklist developed and followed.

review the facilities and standard operating procedures checklist

Sub-action 3.5: Blood testing, laboratory analyses and malaria treatment.

Generation of hazardous and non-hazardous medical waste

Follow best practices and WHO guidelines for drawing blood.

Ensure proper health waste management.Follow USAID Sector Environmental Guidelines Healthcare Waste Partial Update 2015 and WHO guidance on Healthcare wastes.

Protocol for blood draws and management of medical waste and checklist developed and followed.

At least once review the facilities and standard operating procedures checklist


Risks associated with use of pesticides including adverse impacts on human health and environmental pollution

Obtain Uganda government permits for procurement. Follow WHO guidelines for pesticide treated materials.

Utilize only pretreated eave ribbons and tubes. Instruct staff on proper safety measures.

Permit obtained

SOP for handling treated materials developed and followed.

No treatment of eave ribbons on tubes on-site.

At least one unannounced visit


Risks associated with small scale construction including injuries, generation of waste and air, water, and soil pollution and noise.

Ensure safety of all installers including safe use of tools and wearing appropriate PPE. Follow USAID Sector Environmental Guideline: Construction (2017)

Ensure that health facilities have been notified of the study in case residents are presented to the facility with symptoms.

# of people trained in safe installation

% of people installing safely and using PPE.

% of health facilities servicing pilot community notified.

At least once unannounced visit to site





Documents

Project/Activity Data · Web viewThis activity, as noted in the project summary, will use pesticides in a controlled, pilot study, and therefore, the procedures set forth in 216.3(b)(1)