COVERSHEET INITIAL ENVIRONMENTAL EXAMINATION

Sustainably Improving Maternal, Newborn and Child Health

1. EXECUTIVE SUMMARY

1.1. PROGRAM/ACTIVITY DATA

Program/Activity Number TBD

Program/Activity Title Sustainably Improving Maternal, Newborn and Child Health

Country/Region Global

USG Foreign Assistance TBD Framework

Period Covered 2019-2026

Life of Project Amount $TBD over 5 years

IEE Amendment No

IEE Prepared By Amanda Quintana GH/MCHN/CHI and Claire Karlsson GH/MCHN/CHI

Management Unit Contact Point Emily Hillman GH/MCHN/MNH

1.2. ENVIRONMENTAL ACTION RECOMMENDED

Categorical Exclusion X Ne ative Determination X Positive Determination

Project does not cover the following activities

- Procurement or use of pesticides

1.3. THRESHOLD ENVIRONMENTAL DETERMINATIONS

Activity or Activity Category Recommended Determination

Increased availability of quality MNCH Negative Determination with conditions, per: CFR services 216.3(a)(2)(iii}, for activities that may have an effect on

the physical and natural environment but will not have a significant effect as a result of limited scope, carefully controlled nature and effective monitoring according to best management practices.

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Activity or Activity Category Recommended Determination

Improved MNCH practic~s at the Negative Determination with conditions, per: CFR individual , family, and community level 216.3(a)(2)(iii), for activities that may have an effect on

the physical and natural environment but will not have a significant effect as a result of limited scope , carefully controlled nature and effective monitoring according to best management practices.

Increased utilization of MNCH services Negative Determination with conditions , per: CFR by target populations 216.3(a)(2)(iii), for activities that may have an effect on

the physical and natural environment but will not have - a significant effect as a result of limited scope ,

carefully controlled nature and effective monitoring according to best management practices .

Improved capacity of national health Categorical exclusion, per: 22 CFR 216.2(2)(c)(2)(i ) systems and organizations to respond *for all activities consisting of education , technical to shocks and health transitions assistance or training programs, except to the extent affecting MNCH such programs include activities directly affecting the

environment (such as construction of facilities , etc.).

Improved capacity of national health Categorical exclusion , per: 216.2(c)(2)(viii) for systems to plan for and provide high programs involving nutrition, health care, or population quality routine MNCH services and family planning services except to the extent including emergency care designed to include activities directly affecting the

environment (such as construction of fac ilities, water supply systems , waste water treatment , etc.)

Strengthened sub-national and Categorical exclusion , per: 216.2(c)(2)(viii) for community health systems to narrow programs involving nutrition , health care, or population equity gaps 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 wate r treatment, etc.)

Increased availability of global, Categorical exclusion , per: 216.2 (c)(2)(iii ) for regional, and country-specific evidence analyses, studies, academic or research workshops and data for decision-making at policy and meetings . and programmatic levels

Expand knowledge management and Categorical exclusion , per: 216.2 (c)(2)(iii) for transfer for MNCH policies and analyses , studies, academic or research workshops programs and meetings

Expanded knowledge management Categorical exclusion, per: 216.2 (c)(2)(iii) for and transfer for MNCH policies and analyses , studies , academi c or research workshops programs and meetings

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Activity or Activity Category Recommended Determination

Innovative practices tested and Categorical exclusion, per: 216.2(c)(2)(viii) for adopted to improve equitable access to programs involving nutrition, health care, or population MNCH services 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.)

1.4. SUMMARY OF IMPLEMENTATION, MONITORING, AND REPORTING MEASURES

1. Environmental Management Training. The GH AOR/COR and Activity Manager(s) assigned to this program are to enroll in and successfully complete the Bureau for Global Health Environmental Management Process Training course. The course is offered through

GHPOD.

2. Climate Change. GH projects awarded after October 1, 2016 are required to follow USAID/GH guidelines for the screening of activities for climate resiliency to comp ly with EO 13677.

3. Provision of the IEE. The AOR/COR shall provide the Implementing Partner with a copy of this IEE and brief the Implementing Partner on their environmen tal compliance

responsibilities.

4. AOR/COR monitoring responsibilities. As required by the ADS 204, the AOR will actively monitor and evaluate whether the cond itions of this IEE are being impleme nted effectively and whether new or unforeseen consequences arise during implementation not identified and reviewed in this IEE. If new or unforeseen consequences arise , the team will suspend the activity and initiate appropriate , further review, in accordance with 22 CFR 216.

5. Annual compliance documentation and reporting. The Implementing Partner is responsible for the preparation of an Environmental Mitigation and Monitoring Plan (EMMP) and submitting the completed plan to the AOR/COR for review and approval with the project workplan and prior to initiating work on the activity. The EMMP template is included with the IEE. The EMMP will outline the environmental impacts that can be reasonably anticipated from the implementation of the program activities, the mitigation measures to address the impacts, monitoring measures, and frequency of inspection. The AOR/COR is responsible for reviewing and approving the EMMP and providing a copy to the Global Health BEO for review and concurrence.

The Implementing Partner is responsible for annually preparing and submi tting to the AOR/COR an Environmental Mitigation and Monitoring Report (EMMR) to docume nt compliance with the conditions of this IEE. The EMMR must be submitted to the AOR/COR within 45 days after the end of each fiscal year. The EMMR temp late is attached to the IEE.

6. Integration of compliance responsibilities in prime and subcontracts, agreements,

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and grants. The AOR/COR shall ensure that the cooperative agreement document references and requires compliance with the conditions set out in this IEE, as required by ADS 2014.3.4(a)(6) and ADS 303.3.6(3)(e) . The Implementing Partner shall assure that subcontracts, agreements , and grants reference and require compliance with relevant elements of these conditions.

7. Assurance of sub-awardee, -grantee, -contractor capacity and compliance. The Implementing Partner shall assure that sub-awardees, grantees, contractors have the capability to implement the relevant requirements of this IEE. The Implementing Partner shall , if appropriate, provide training to sub-awardees , -grantees, and -contractors in their environmental compliance responsibilities.

8. Pesticides or pesticide products. Any program activities conducted under this Agreement involving the procurement, use, research or disposal of pesticides and/or larvicides and their waste products will require a supplemental IEE, SEA, or PERSUAP based on consultations with the Bureau Environmental Officer for Global Health.

9. Compliance with human subject research requirements. The AOR/COR in consultat ion with the BEO for the Global Health Bureau shall assure that the Implementing Partner and sub-awardees 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. The BEO for Global Health may request copies of documentation from the AOR/COR to demonstrate compliance with applicable requirements of human subject trials . All documentation demonstrating completion of required review and approval of 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.

10. New or modified activities. As part of its workplan, the implementing partner in collaboration with the AOR shall review all on-going and planned activities to determine if they are within the scope of this IEE. The Implementing Partner shall complete the screening questionnair e (Part 1 of the EMMR) with the workplan.

a. If activities outside the scope of this IEE are planned, the AOR/COR shall assure that an amendment to this IEE addressing these activities is prepared and approved prior to implementation of any such activit ies. b. Any ongoing activities found to be outside the scope of this IEE shall be modified to comply or halted until an amendment to this IEE is submitted and approved.

11. Compliance with Host Country requirements. Nothing in this IEE substitutes for or supersedes Implementing Partner, sub-awardees/ -grantee/-contractor's responsibility for compliance with all applicable host country laws and regulations . The Implementing Partner and sub-awardee, -grantee, -contractor must comply with host country environmental regulations unless otherwise directed in writing by USAID . However , in the case of a conflict between host country and USAID regulations , the latter shall govern.

12. Waste Management Plan. The IP will prepare an integrated Waste Management Plan (WMP) or equivalent standard operating procedures (SOPs) that will define and detail direct

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and indirect waste streams generated by IP-managed activities and specify appropriate management and disposal practices for each. The primary components required in a WMP are described in Annex D.

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Dennis W DurbinDigitally signed by Dennis W Durbin DN: c=US, o=U.S. Government, ou=Department of State, ou=PIV, cn=Dennis W Durbin, serialNumber=990100000000000000014000000010F4 Date: 2018.07.03 11:12:11 -04'00'

1.5.APPROVAL OF ENVIRONMENTAL DETERMINATION AND MEASURES

ra Hughes Office Director, Bureau for Global Health, Maternal Child Health and Nutrition

Date

Emily Hill an Date Bureau for Global Health, Maternal Child Health and Nutrition

1.5.2. Concurrence:

Dennis Durbin Date Acting Global Health Bureau Environmental Officer

1.5.3. Distribution List:

1 I

AOR/COR or designee is responsible for distributing the approved IEE to stakeholders on the distribution list below. Stakeholders may include Regional BEOs and REAs,

among others.

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SECTION 2: IEE SUPPORTING INFORMATION

2.1. PROGRAM/ACTIVITY DATA

Program/Activity Number TBD

Program/Activity Title Sustainably Improving Maternal, Newborn and Child

Health

Country/Region Global

USG Foreign Assistance TBD

Framework

Period Covered 2019-2026

Life of Project Amount $TSO over 5 years

IEE Amendment No

IEE Prepared By Amanda Quintana GH/MCHN/CHI and Claire Karlsson GH/MCHN/CHI

Management Unit Contact Point Emily Hillman GH/MCHN/MNH

2.2. PURPOSE AND SCOPE

The purpose of this document, in accordance with Title 22, Code of Federal Regulations , Part 216 (22 CFR 216) , is to provide a preliminary review of the reasonably foreseeable effects on the environment of the Improving Maternal, Newborn and Child Health Project , and on this basis, to recommend determinations and, as appropriate, attendant conditions, for these activities . Upon final approval of this IEE, these recommended determinations are affirmed as 22 CFR 216 Threshold Decisions and Categorical Exclusions , and conditions become mandatory elements of Improving Maternal , Newborn and Child Health Project implementation.

The goal of the Improving Maternal, Newborn and Child Health Project is to contribute to achieving the Agency's global MNCH priorities from 2019-2024 . Through a coordinated portfolio of centrally -managed investments, the project will promote appropriate , context ­specific , and targeted technical assistance and capacity development to meet USAID­supported countries' needs , as well as continue to play a critical leadership role in advancing both global learning and policy-development for MNCH. The project 's total estimate cost is $760 million over 5 years , including field and core funds.

This IEE is a critical element of a mandatory environmental review and compliance process meant to achieve environmentally sound activity design and implementation .

2.3. PROGRAM OVERVIEW

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2.3. PROGRAM OVERVIEW

2.3.1. Background

Despite tremendous improvements in the health status of women and children globally through the millennium development goal era (2000-2015) , these gains have not been evenly shared across countries. Similarly , inequities within many countries have grown. A significant unfinished agenda to improve maternal , newborn and child health (MNCH) remains . In response, under the guiding framework of the Sustainable Development Goals, the global health community has committed to ending all preventable deaths of women, children and adolescents within a generation and ensuring their well-being . Achieving these ambitious global goals by 2030 necessitates a coordinated and targeted approach to further accelerate progress in mortality reduction to ensure that mothers , their children and families survive and thrive. Given the importance to strategically use limited resources, thoughtful investments are required to catalyze and accelerate country-led progress .

As a part of USAID's continuing quest to be the world's pre-eminent development agency, USAI D's Bureau for Global Health (GH) will continue to make investments in alignment with evidence-based global best practices and global goals in MNCH . Current awards made through GH's centrally-managed maternal and child health portfolio, including the flagship Maternal and Child Survival Program (MCSP), Ending Eclampsia , Every Preemie , Postabortion Care Family Planning, and Fistula Care Plus, will end in 2019. This Project , which comprises a constellation of Activities , will be awarded and managed by the Office of Maternal and Child Health and Nutrition (MCHN) of USAID/Washington's Bureau for Global Health that will contribute to achieving the Agency 's MNCH priorities from 2019-2024. The activities described here do not constitute the totality of MCHN investments contributing to the Agency 's goal of prevention of child and maternal mortality .

The three Objectives of this Project will be 1) Increased and sustained coverage of high quality, high impact MNCH interventions in fragile settings , 2) Enhanced country ownership , leadership, and accountability of health systems to respond to MNCH needs of populations, and 3) Increased adoption and application of learning , evidence, and innovative practices in MNCH.

Through this project , USAID aims at the global level to: • Influence global policies and guidelines • Support countries to scale-up high impact , evidence-based interventions and best

practices • Catalyze deployment of new approaches and technologies • Continue to evolve USAI D program focus from direct program implementation to

support country-level programming • Enhance support to strengthen health systems • Exploit USAID's position as a multi-sect oral development agency to promote

better health outcomes • Advance equity in health outcomes and access

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Country level aims include implementing strateg ic approaches for providing technical leadership in scaling up evidence-based , equitable and locally adapted health solutions by working with key partners , including government to government , private and non­governmental organizations , private sector and community organizations .

Goal: By 2030, all USAID-supported countries are on track to meet globa l targets in maternal , neonatal, and child health

Purpose: Increased and sustained coverage of high quality , high impact MNCH interventions and approaches

The types of mechanisms that may be awarded in support of this MNCH project included

the following:

Mechanism 1 The MNCH in Fragile Settings activity will focus on supporting MNCH service delivery in fragile environments. According to USAID , country fragility can be defined as ....... Increasingly , poverty is concentrated in countries experiencing fragility and conflict , intensifying pre-existing development challenges. 1 Natural or man-made shocks frequently result in short or long-te rm increases in maternal , neonatal and child mortality . Fragility-related challenges vary and can include weak government institutions, economic instability , and internal displacement of people , among other things. Countries facing fragility have unique needs requiring tailored approaches and considerable flexibility in responsiveness and support . This activity will respond to this development challenge by supporting low-income countries experiencing national or subnational fragility and that have a high burden of maternal and child mortality. The activity will support the restoration and stabilization of functional MNCH health service provision and improve MNCH health outcomes in settings at risk of descending into or transit ioning out of humanitarian response. In addition, this activity will support countries to overcome the impacts of fragility on the health of its population and increase the resilience of communities and facilities to provide MNCH services. In doing so, this support will move countries along the continuum of development toward dec reased maternal and child mortality and increased self-reliance. Key characteristics of this activ ity will be in-built flexibility that can be accessed and mobilized quickly and effectively to respond to country-sp ecific dynamics. The mandate of this activity will be accomplished through the core principle of country ownership and leadership , utilization of adaptive management principles, promotion of iterative feedback loops for learning and ongoing cou rse correction in development activities.

This activity will provide a core set of evidence-based interventions and approaches at the community , facility , regional , and national levels . In the context of fragile states ,

1 Global Partn ership on Outp ut Based Aid . June 2015. "Output Based Aid in Confli ct and Fragile Sett ings" Accessed at: htt ps:// www .gpoba.org/sites/g poba/fil es/OBA47 _FCS .. pdf

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disasters, conflict , and other acute vulnerabilities , meaningful and sustainable impact requires complementary action by humanitarian and development actors .· Development actors should engage early with humanitarian actors to bridge the humanitarian and development spaces, facilitating and expediting the transit ion to increased stability for the population. The expertise brought by this activity will complement, not replace or duplicat~. that of traditional humanitarian actors. This activity will work synergistically with and leverage investments of other USAID activities that support emergency programming and resilience. The activity will also help inform the appropriate role for development actors in acute humanitarian settings that will complement the work of traditional emergency actors. The activity will allow for rapid mobil izations and quick adaptation to provide short or long-term support in countries , as the situation dictates, through engagement in both the public and private sectors.

The MNCH in Fragile Settings activity will support linkages to related multi-secto ral priorities where possible , thereby taking into account a holistic approach to meeting the health needs for women and children across the lifespan . The learning agenda in this activity will support overall M&E and be expected to contribute to the nascent research to guide development investments in fragile settings. As part of the learning agenda, the activity will explore opportunities to improve implementation and share innovative and equity-oriented programmatic approaches as a means to achieving improved health in fragile settings. This activity will also play a role in global leadership, in harmony with Target MNCH, to shape and lead on issue areas relating to MNCH in fragile settings , advancing the adoption of evidence-based policy and programming, etc.

Mechanism 2 The Target MNCH activity will have two primary areas of focus: 1) to provide targeted technical and capacity development assistance to USAID Missions and partner countries to improve service-delivery of quality, high-impact maternal, newborn, and child health interventions and approaches; and 2) to contribute to global technical learning and policy-dialogue for achievement of global MNCH targets.

As countries transition along the economic development continuum, so too do their deve lopment assistance for health needs. Increased domestic resource mobilization offers new opportunities to transform traditional development partnerships and increase self-reliance as host country governments can increasingly take over routine health service delivery. USAID's development assistance for health in these countries has already or will progressively shift focus from funding comprehensive service delivery programming to providing technical guidance and capacity-building for specific predetermined areas of need . This activity will fulfill the evolving and diverse technical assistance and capacity-development needs for sustained improvements in maternal , newborn, and child health in these countries advancing them along the pathway to sustained self-reliance . To accomplish this end, activities under this award will be centered on ensuring that all activities are country-identified, country -owned, and

government-led .

Target MNCH will provide targeted and catalytic technical assistance and capacity-

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development at the national and sub-national levels for improved maternal, newborn, and child health outcomes in USAID-supported countries. This activity will serve as a MNCH technical assistance hub for USAID Missions with the ability to provide focused and strategic assistance to supplement the Missions' portfolio of activities and hone in on specific technical areas where gaps or lack of progress have been identified (e.g. increasing proportion of neonatal deaths due to prematurity or stagnant number of under­five deaths due to pneumonia) . This activity will house expertise in MNCH , community health, gender, and be able to work at all levels of the health system. As for most interventions in the health sector , the sustainability , quality, and coverage of MNCH services is, to a large extent, determined by the performance of the overall health system in which they are implemented. As such, Target MNCH will wor_k synergistically with the Office of Health System's IDIQ activity and leverage their technical leadership to ensure any health systems activities employ state of the art, technically-sound health systems strengthening approaches , and utilize a systems-thinking lens. Target MNCH will employ intersectoral approaches and engage the private-sector for improved MNCH health outcomes. In addition to provision of targeted technical assistance , Target MNCH will support ongoing project learning across the two flagship activities including the continual review and interpretation of monitoring data for programmatic decision-making .

Critical to accelerating sustained improvements in MNCH health outcomes is the availability of global learning, guidance , and policy on evidence-based, state of the art interventions and approaches and their application at the country level. USAID has historically played a significant leadership role in fostering effective program learning, policy , and accountability for improved MNCH outcomes across the continuum of care. Target MNCH will enhance this engagement on behalf of USAID and ensure the crucial links between knowledge generation, global dialogue , and country action . While the Support for MNCH in Fragile Settings activity will contribute to global learning and dialogue on MNCH programming in fragile settings, Target MNCH will facilitate USAID's broader MNCH global technical leadership and contributions to global policy-dialogue. Target MNCH will work closely with all activities under this PAD to inform global learning as well as coordinate with existing activities such as CIRCLE .

Mechanism 3 The Overcoming Entrenched MNCH Obstacles activity goal is to focus on innovative and technically -sound approaches to overcome MNCH challenges adversely affecting the objective to prevent maternal and child mortality . Specific addenda can be issued to target political priorities that may arise as well as cross-cutting MNCH issue areas rising to priority level and requiring targeted resources. A co-creation approach will allow USAID to encourage a wide variety of partners , including those who have never worked with USAID before, to apply and form creative partnerships to advance the MNCH agenda. Multiple topics are expected to be addressed through this umbrella announcement to "overcome entrenched MNCH obstacles ". Support to public private partnerships to advance specifi c prioritized topics in MNCH are also encompassed in this

activity.

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Mechanism 4 As a follow-on to the current CIRCLE award, CIRCLE 2.0 will provide targeted technical support and expertise for research and research utilization activities conducted by other activities to advance the research-to-use processes. Its collaborative learning and research translation efforts will systematically assist in tracking advances and working with partners to translate results to (a) accelerate introduction and scale-up of an MNCH intervention; (b) facilitate the use of results to inform MNCH policy changes ; and (c) serve as a sustainable means for documenting MNCH research efforts and results of research

uptake. ·

2.3.2. Description of Activities

This Project is designed to achieve results under the following results framework and set

of activities: • IR - Increased availability of quality MNCH services • IR - Improved MNCH practices at the ·individual, family, and community level

• IR - Increased utilization of MNCH services by target populations • IR - Improved capacity of national health systems and organizations to respond to

shocks and health transitions affecting MNCH • IR - Improved capacity of national health systems to plan for and provide high

quality routine MNCH services including emergency care • IR - Strengthened sub-national and community health systems to narrow equity

gaps • IR - Increased availability of global, regional , and country-specific evidence and

data for decision-making at policy and programmatic levels • IR - Expand knowledge management and transfer for MNCH policies and

programs • IR - Expanded knowledge management and transfer for MNCH policies and

programs • IR - Innovative practices tested and adopted to improve equitable access to

MNCH services

Under these results framework Intermediate results , the PAD design team analyzed the following categories of activities for potential impact on the environment:

Each category will have a number of related activities and illustrative examples of activities are provided below. Potential impacts of activities will be analyzed and incorporated into the EMMP more specifically to each mechanism as they are awarded.

• Convening meetings and workshops, facilitation of collaborative learning and information transfer/research utilization, and secondary data analysis

o Activities include stakeholder engagement, systematic multi-disciplinary analyses of advances and challenges, consensus building and communication within and across global, national, and local settings are critical to successful planning , priority setting , and roll out of applied implementation research and uptake of new or refined tools, technology,

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policies , and products. This poses no adverse environmental risks, therefore qualifying for categorical exclusion.

• Development Research o Activities include development research in market , formative , and

behavioral research. Social science implementation, health services , and operational research, when USAID is supporting health facilities and service delivery research, may involve medical waste management and/or

healthcare commodit ies. • Technical assistance

o Technical assistance may support but is not limited to: service delivery , including antenatal care, skilled birth attendance, prevention of postpartum hemorrhage, emergency obstetric care, postpartum care, essential newborn actions , treatment of severe newborn infection, Vitamin A distribution, infant and young child feeding , prevention of diarrhea, treatment of child illness , family planning , other reproductive and prevention of maternal-to-child transmission of HIV and Pediat ric HIV Care and Treatment , Health Policy and Systems Strengthening , Monitoring and Evaluation , Research and Analysis .

• Training and/or capacity building o Activities in this category include training and assistance in managing

medical waste or healthcare commodities, for small-scale rehabilitation of health posts , clinics, laboratories , hospitals or training centers , for small­scale water and sanitation activities .

• Direct Health Service Delivery/ Provision of Health Services: o Activities include management of medical waste or healthcare

commodities. • Procurement, Storage, Management and Disposal of Public Health

Commodities o Activities in this category include efforts to strengthen the supply chain of

public health commodities. In some cases , commodit ies may be

procured . • Small scale rehabilitation of facilities

o Activities in this category include minor renovation of existing facilities , including rehabilitation of clinics, latrines, wells and incinerators to improve the quality of service delivery . No major construction activities will be

conducted.

2.4 . BASELINE INFORMATION AND APPLICABLE HOST COUNTRY REQUIREMENTS

2.4.1. Locations Affected

This Project has a global focus and activities may take place in any of the developing countries covered by a bilateral or regional USAID mission. Host count ry environme ntal requirements are detailed in national laws, regulations, and policies. Research activities involving human subjects will be carefully designed, implemented, and monitored in compliance with in-country laws and regulations , and specifically with local institutional

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review board (IRB) approval.

The global nature of this award requires that potential site-specific impacts are assessed at the project workplan level. As such , Supplemental Initial Environmenta l Examinations (SIEEs) will be prepared once mechanisms are developed from the PAD. In addition, EMMPs will be developed and processed by Implementing Partner's for individual awards with the GH BEO, REO and MEO approval.

2.4.2. Applicable Laws, Regulations and Policies

The Project will be responsible for complying with all applicable country and environmental standards in each country where it implements activities. Specific requirements may vary by country, but activities will conform to environmental management laws and environmental impact regulations, as applicable , including health care waste management polic ies. .

In addition to host country requirements, the C/AORs will consult WHO guidelines , USAID sector guidelines, and CDC, where applicable, to ensure comp liance with internationally recognized environmental procedures. In the EMMP, the implementing partner will outline how the host country environmental laws, regulations and possible permit requirements will be identified and adhered to as part of their program management. The EMMP must also analyze and address the implications of project activities in terms of medical waste management. Where host country requirements on medical waste management associated with commodity disposal do not exist, WHO 's "Safe Management of Wastes from Healthcare Activities" handbook is the internationally­recognized standard used by the Global Health Bureau.

For example , implementing partners are responsible for documenting consultations with the relevant host country agen.cy(ies) to ensure that environmental discharges (air, water, soil) meet host county environmental standards and permits are obtained where required. Technical assistance to help host countries deve lop, implement, finance, or monitor regulations, policies, procedures, or standards that relate to medical waste management must align with WHO guidelines.

Primary Environmental Compliance References : • WHO . Safe Management of Wastes from Health-Care Activities (2014)

• John Snow, lnc./USAID DELIVER Project in collaborat ion with WHO . Guidelines for the Storage of Essential Medicines and Other Health Commodities (2003)

Secondary Environmental Compliance References: • USAID Sector Environmental Guidelines • USAID DELIVER Project. The Logistics Handbook : A Practical Guide for the

Supply Chain Managem ent of Health Commodities (2011)

• USAID DELIVER Project. Transport Management : A Self-Learning Guide for Local Transport Managers of Public Health Services (October 2010)

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2.5. EVALUATION OF POTENTIAL ENVIRONMENTAL IMPACTS

The activities under this Project are numerous and complex. Many activities such as information, education, communication , community mobilization, planning, management, leadership , and outreach activities do not have direct adverse environmental impacts. However, in the course of implementation of these activities, implementing partners should take advantage of opportunities to incorporate and improve means of addressing environmental health issues (like hazardous and infectious waste management) into service delivery systems.

Certain activities supported by the Improving Maternal, Newborn and Child Health Project will directly or indirectly affect the environment or have the potential to do so. The PAD team analyzed the potential activities and determined the following activities could affect the environment:

1. Development Research: market, formative, behavioral, social science, implementation , health services and operational research, which may involve medical waste management and/or healthcare commodities. Poor waste management practices can unintentionally do harm to communities even when overall intentions for an activity are well meaning. Improper training, handling , storage and disposal of the waste generated in facilities or activities increases the risk of transmission of disease . Examples of populations who may be at risk to transmission of disease include healthcare workers , cleaning staff, patients, visitors, waste collectors, disposal site staff, waste pickers, substance abusers and those who knowingly or unknowingly use "recycled" contaminated syringes

and needles. 2. Applied and development research to evaluate barriers and facilitators to

implementation of new products and technologies , which may involve medical waste management and/or healthcare commodities . Potential environmental impacts are described above.

3. Technical assistance, training, and capacity building of local organizations involving medical waste or healthcare commodities. Training is one of a class of activities under 22 CFR 216 eligible for categorical exclusion. However , training of healthcare providers is intended to improve and expand the delivery of and/or access to health care services. The delivery of these services presents a set of potentially significant adverse environmental impacts, particularly waste-related.

4. Health Service Delivery activities involving medical waste or healthcare commodities . Improper training, handling, storage and disposal of the waste generated in health care facilities or activities can spread disease.

5. Procurement, storage, management, distribution and disposal of public health commodities . Many procured commodities inevitably end up as waste (e.g. condoms, laboratory chemicals, test kits), generate waste as a consequence of their use (e.g. injectable pharmaceuticals); or have the potential to end up as waste due to spoilage or expiration (all pharma ceuticals). Improper disposal of potentially infectious and pharmaceutical wastes has potentially significant adverse impacts as described above .

6. Small~scale rehabilitation of facilities. While major construction activities are

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not planned, rehabilitation of facilities may result in adverse environmental impacts including improper siting, erosion , creation of breeding habitat for disease vectors , contamination of ground and surface water, etc.

In addition , this project may do some small-scale water and sanitation rehabilitation work . These activities may include renovation and/or maintenance of hand-dug wells in order to support the infection prevention control through good hygiene practices at rural clinics and hospitals. Small-scale water and sanitation work has potential adverse impacts described below:

a. Worker health and safety impacts from manual construction techniques , potential construction hazards to workers from soil collapse when working inside well excavations, and shallow groundwater susceptible to

contamination. b. Water supply systems may become contaminated during construction ,

operation , or maintenance activities if equipment is not kept clean or debris enters the supply systems. This can lead to adverse health impacts to system users and surrounding communities from waterborne disease and illness.

7. Procurement, installation, or operation of incinerators. The combust ion from small-scale incinerators can result in the release of heavy metals , toxic and acid gases , and particulate matter into the surrounding community and environment. Incineration also results in the generation of residual ash. Improper incineration of wastes and disposal of residual ash can pose a threat to air quality, soil, and the water supply and result in environmental and public health hazards .

Incinerators with capacities to destroy more than 100 kilograms of waste per hour (or multiple installations servicing a facility that , in total , exceed this threshold) , will receive a Positive Determination , per 22 CFR 216.3(a)(2)(ii i), with resulting scoping study and, if necessary, an Environmental Assessment developed and approved by the AOR/COR and the Global Health BEO.

The specific environmental impacts for each award will be identified in more detail through Supplemental Initial Environmental Examinations (SIEEs) once mechanisms are developed from the PAD.

2.6. RECOMMENDED DETERMINATIONS AND CONDITIONS

Following from the analysis , the following determinations and conditions are recommended .

2.6.1. Recommended Determinations

Activity or Activity Category Recommended Determination

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...... . Activity or Activity Category Recommended Determination

Increased availability of quality MNCH Negative Determination with conditions, per: CFR services 216.3(a)(2)(iii), for activTties that may have an effect on

the physica l and natural environment but will not have a significant effect as a result of limited scope, carefully contro lled nature and effective monitoring according to best management practices.

Improved MNCH practices at the Negative Determination with conditions, per: CFR individual , family, and community level 216.3(a)(2)(iii), for activities that may have an effect on

the physical and natural environment but will not have a significant effect as a result of limited scope, carefu lly controlled nature and effective monitoring according to best management practices.

Increased utilization of MNCH services Negative Determination with conditions, per: CFR by target populations 216.3(a)(2)(iii), for activities that may have an effect on

the physical and natural environment but will not have a significant effect as a result of limited scope, carefully controlled nature and effective monitoring according to best management practices.

Improved capacity of national health Categorical exclusion, per: 22 CFR 216.2(2)( c)(2)(i) systems and organizations to respond *for all activities consis ting of education , technical to shocks and health transitions assistance or training programs , except to the extent affecting MNCH such programs include activities directly affecting the

environment (such as construction of facilities, etc.).

Improved capacity of national health Categorical exclusion, per: 216.2(c)(2)(viii) for systems to plan for and provide high programs involving nutrition, health care, or population quality routine MNCH services and family planning services except to the extent including emergency care designed to include activities directly affecting the

. ·•. environment (such as const ruction of facilities, water supply systems , waste water treatment, etc.)

Strengthened sub-national and Categorical exclusion, per: 216.2(c)(2)(vi ii) for community health systems to narrow programs involving nutrition, health care , or population equity gaps 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.)

Increased availability of global, Categorical exclusion, per: 216.2 (c)(2)(iii) for regional, and country-specific evidence analyses, studies, academic or research workshops and data for decision-making at policy and meetings. and programmatic levels

Expand knowledge management and Categorical exclusion, per: 216.2 (c)(2)( iii) for transfer for MNCH policies and analyses, studies, academic or research workshops programs and meetings

pg. 18 5/29/18

Activity or Activity Category Recommended Determination

Expanded knowledge management Categorical exclusion, per: 216.2 ( c)(2)(iii) for and transfer for MNCH policies and analyses, studies , academic or research workshops programs and meetings

Innovative practices tested and Categorical exclusion , per: 216.2(c)(2)(viii) for adopted to improve equitable access to programs involving nutrition , health care, or population MNCH services 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 .)

2.6.2. Recommended Conditions

1. Environmental Management Training. The GH AOR/COR and Activity Manager(s) assigned to this program are to enroll in and successfully complete the Bureau for Global Health Environmental Management Process Training course. The course is offered through GHPOD.

2. Climate Change. GH projects awarded after October 1, 2016 are required to follow USAID/GH guideli nes for the screening of activities for climate resiliency to comply with EO 13677.

3. Provision of the IEE. The AOR/COR shall provide the Implementing Partner with a copy of this IEE and brief the Implementing Partner on their environmental compliance responsibilities .

4. AOR/COR monitoring responsibilities . As required by the ADS 204, the AOR will actively monitor and evaluate whether the condit ions of this IEE are being implemented effectively ·and whether new or unforeseen consequences arise during implementation not identified and reviewed in this IEE. If new or unforeseen consequences arise , the team will suspend the activity and initiate appropriate, further review, in accordance with 22 CFR 216.

5. Annual compliance documentation and reporting. The Implementing Partner is responsible for the preparation of an Environmental Mitigation and Monitoring Plan (EMMP) and submitting the completed plan to the AOR/COR for review and approval with the project workplan and prior to initiating work on the activity. The EMMP template is included with the IEE. The EMMP will outline the environmental impacts that can be reasonably anticipated from the implementation of the program activities , the mitigation measures to address the impacts, monitoring measures , and frequency of inspection. The AOR/COR is responsible for reviewing and approving the EMMP and providing a copy to· the Global Health BEO for review and concurrence .

The Implementing Partner is responsible for annually preparing and submitting to the

pg. 19 5/29/18

AOR/COR an Environmental Mitigation and Monitoring Report (EMMR) to document compliance with the conditions of this IEE. The EMMR must be submitted to the AOR/COR within 45 days after the end of each fiscal year. The EMMR template is attached to the IEE.

6. Integration of compliance responsibilities in prime and subcontracts, agreements, and grants. The AOR/COR shall ensure that the cooperative agreement document references and requires compliance with the conditions set out in this IEE, as required by ADS 2014.3.4(a)(6) and ADS 303.3.6(3)(e). The Implementing Partner shall assure that subcontracts, agreements, and grants reference and require compliance with relevant elements of these conditions .

7. Assurance of sub-awardee, -grantee, -contractor capacity and compliance. The Implementing Partner shall assure that sub-awardees, grantees, contractors have the capability to implement the relevant requirements of this IEE. The Implementing Partner shall, if appropriate, provide training to sub-awardees, -grantees, and -contractors in their environmental compliance responsibilities.

8. Pesticides or pesticide products. Any program activities conducted under this Agreement involving the procurement , use, research or disposal of pesticides and/or larvicides and their waste products will require a supplemental IEE, SEA, or PERSUAP based on consultations with the Bureau Environmental Officer for Global Health.

9. Compliance with human subject research requirements. The AOR/COR in consultation with the BEO for the Global Health Bureau shall assure that the Implementing Partner and sub-awardees 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. The BEO for Global Health may request copies of documentation from the AOR/COR to demonstrate compliance with applicable requirements of human subject trials. All documentation demonstrating completion of required review and approval of 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.

10. New or modified activities. As part of its workplan, the implementing partner in collaboration with the AOR shall review all on-going and planned activities to determine if they are within the scope of this IEE. The Implementing Partner shall complete the screening questionnaire (Part 1 of the EMMR) with the workplan .

a. If activities outside the scope of this IEE are planned , the AOR/COR shall assure that an amendment to this IEE addressing these activities is prepared and approved prior to implementation of any such activities. b. Any ongoing activities found to be outside the scope of this IEE shall be modified to comply or halted until an amendment to this IEE is submitted and approved.

11. Compliance with Host Cou·ntry requirements. Nothing in this IEE substitutes for or supersedes Implementing Partner, sub-awardees/-grantee/ -contractor's responsibility for compliance with all applicable host country laws and regulations. The Implementing Partner and sub-awardee , -grantee, -contractor must comply with host country environmental

pg.2 0 5/29/ 18

regulations unless otherwise directed in writing by USAID. However , in the case of a conflict between host country and USAID regulations, the latter shall govern.

12. Waste Management Plan. The IP will prepare an integrated Waste Management Plan (WMP) or equivalent standard operating procedures (SOPs) that will define and detail direct and indirect waste streams generated by IP-managed activities and specify appropriate management and disposal practices for each. The primary components required in a WMP

are described in Annex D.

2.7. MONITORING AND REPORTING

The Implementing Partner and the AOR/COR , in consultation with the BEO, will actively monitor and evaluate whether environmental consequences unforeseen under activities covered by this IEE arise during implementation and modify or end activities as appropriate. Monitoring and reporting will be documented via the Environmental Mitigation and Monitoring Template (EMMT) .

The EMMT consists of three parts:

The Environmental Screening Form

The AOR/COR conducts annual screenings of their projects using the Environmental Screening Form to determine whether project activities and annual workplans remain within the scope of the activities reviewed during the IEE process . For sub- projects , sub­grants , and sub-activities , Implementing Partners must annually screen their activities and submit the completed form to the AOR/COR. If an activity does not fall within the scope of this IEE, a supplemental or amended environmental document must be

prepared.

The Environmental Mitigation and Monitoring Plan (EMMP)

The Implementing Partner is responsib le for submitting the Environmental Mitigation and Monitoring Plan (EMMP) to the AOR/COR for review and approval. The GH BEO concurs on the EMMP. The EMMP is submitted with the workplan, after clearance of this IEE and prior to initiating project work. Implementing Partners will use the EMMP to describe the specific actions they will undertake under each category of activity when screening reveals potential environmental impacts as outlined in Section 2.5 of this IEE. The EMMP also identifies the person responsible for monitoring compliance with mitigation measures and the indicator, method , and frequency of monitoring . Refer to the attached GH EMMP Template.

The Environmental Mitigation and Monitoring Reporting (EMMR)

Annually , the Implementing Partner is responsible for completing the Environmental Mitigation and Monitoring Report (EMMR) and submitting it to the AOR/COR. The

pg.21 5/29/18

EMMRs are reviewed by the AOR/COR and the BEO (and/or MEO, as appropr iate) . The EMMRs ensure compliance with 22 CFR 216 and ADS 204.5 by documenting that the conditions specified in this IEE have been met for all activities carried out under Improving Maternal, Newborn and Child Health Project by reporting on the results of applying the mitigation measures described in the EMMP and identifying outstanding issues with respect to required conditions. Verification may require digital photos and/or

site visits .

The Implementing Partner for Improving Maternal, Newborn and Child Health Project will submit the EMMR on all activities within 60 days after the end of each fiscal year for the life of the project, using the QUidance and forms contained in the GH IEE BOP. Any sub­awards, sub-grants , and sub-activities must incorporate provisions stipulating a) the completion of an annual environmental monitoring report and b) that activities to be undertaken will be within the scope of the environmental deter~inations and recommendations of this IEE. This includes assurances that any mitigating measures required for those activities will be followed .

Refer to the attached GH EMMR Template.

pg.22 5/29/18

Project Nrune:

A. Environmenta l Screening Form OUR PROJECT NAM

Original IEE File # /DCN:

Nrune of Priine Implementing Organization: Date of Screening:

N rune of Sub-awardee Organization (if this EMMT is Funding Period for thi s award: for a sub):

-FY FY __ - -

Geographic location of USAID -funded activities Current FY Resourc e Levels: (Provinc e, District):

FY

This report p1:epared by: Date of Previous EMMT for this

Name: organization (if any):

Date:

Indicate which activities your organization is implementing.

Key Elements of Progi ·run/ Activities Implem ent e d Yes

1 Education , Technical Assistan ce, or Trainin g

Includ es: st rategic planning, data analysis, technical consultation, surveys, knowledge and information t ransfer, meetings, technical mater ial development, outreach programs, and trainin g services.

2 Research and Development

Includ es: health-related research and development activities aimed at advancing knowledge and techno logy, includin g resea rch and evaluation , monitorin g and su rveillance, programs, pilot stud ies, case studies, and assessments.

3 Public Health Commodities

Includ es: procurement, storage , transportation, distribu tion, and disposal of public heal th commodities, including pharmac euticals, nutr itional supplements, chemicals (e.g., disinfectants, solvents , laboratory reagents, etc.), medical supplies, and family plannin g commodities (e.g., contraceptives, condoms, etc.).

pg.23 5/29/18

No

4 Small-Scale Construction or Rehabilitation

Includes: hospitals, clinics, laboratorie s, volunta1y and counse ling testing centers, or training centers. Total smface ar ea of the disturbed environment is under 10,000

square feet and less than $200,000 total cost .

5 Small-Scale Water and Sanitation

Includes: pond and spring improvements and installation of hand-dug wells, individual or community latrines, hand -washing stations, and small-scale septic and leach field systems.

6 Nutrition

Includes: small -scale food production, procurement and distribution of supplements, preventing undernutrition, providing nutritional care and suppo 1t, arid improving nutritional outcomes in programs.

7 Vector Control

Includes: procurement, distribution, or use of pesticide products such as insecticide -treated bednets, larviciding agents, and fumigants.

NOTE: USAID uses USEPA's definition of pesticides, which includes "any substance intended for: preventing, destroying, repelling, or mitigating any pest. This includes herbicides, fungicides, plant regulators, and desiccants."

Emergency Response

8 Includes: coordination with outside organizat ions and technical expe1ts, deployment ofresources and response t eams, and development of technical materials.

DESCRIPTION OF ACTIVITIES:

Provide a description of activities with sufficient details to understand the scope and scale of the interventions. The EMMP should reference the governing IEE (GH- or country-level) .

pg.24 5/29/18

B. Environmental Mitigation and Monitoring Plan . ProgralJl]

Add Introduc t ion and additiona l narrat ive here, as needed . . -- - .. --- - -· -· - -- -

Category of Activity Describe specific from Section 2.6 of environmental impacts of Description of Mitigation Who is Monitoring Monitoring Frequency of

-- IEE your organization's activities Measures for these activities as responsib le for Indicator Method Monitoring (based on analysis in Section required in Section 2.6 of _ _ monitoring?

2.5 of the IEE) IEE 1. Education, Technical Assistance, Training

2 . Research and Development

3. Public Health Commodit ies

4. Small-Scale Construction

5. Small-Scale Water and Sanitation

6. Nutrition

7. Vector Control

8. Emergency Response

pg.25 Patg

Prepared by: Date: _______ _

Reviewed and Approved by: [Signatu[~ Date: _______ _

Agreement Officer's Representative/Contracting Officer 's Representative

Concur: §iqnaturs Date: ________ _

GH Bureau Environmental Officer

pg. 26 ©ai'd

C. Environmental Mitigation and Monitoring Report -- . . ' ·Prbaraml

Add Introduction and additional narrative here, as needed. - - - - -- --- - -- -

List each Mitigation Measure from column 3 in the EMMP Status of Mitigation Measures

(EMMT Part 2 of 3)

1. Education, Technical Assistance, Training

2. Research and Development

3. Public Health Commodities

4. Small-Scale Construction

5. Small-Scale Water and Sanitation

6. Nutrition

7. Vector Control

8. Emergency Response

Prepared by: lsignatura Name and Title

pg.27

List any outstanding issues relating to required conditions

Date: _____ ___ _

~

Remarks

Annex D: Waste Management Plan Requirements The Implementing Partner will develop an integrated Waste Management Plan (WMP) or equivalent Standard Operating Procedures (SOPs) that will define and detail direct and indirect

waste streams generated by Implementing Partner-managed activities and specify appropriate

management and disposal practices for each waste stream. The WMP must: Classify and require management of each commodity the project proposes to procure or

manage by level of risk, as per WHO guidance.

Require assessment of local disposal options and requirements and identify, on a country basis, the disposal option for each class of commodity procured or managed. The disposal options identified will comply with host country requirements and be generally consistent with

the following guidelines and resources:

o Pharmaceuticals and chemical wastes-WHO Safe Management of Wastes from Healthcare Activities See particularly 8.11, "Applications of treatment and disposal methods to

specific waste categories."

o Non-contaminated packaging and general wasfe-USAID Sector Environmental

Guidelines: Solid Waste.

Require compliance with the Basel convention on the control of transboundary movement

of hazardous wastes and their disposal: http://www .basel.int/portals/4/basel%20convention/docs/text/baselconvent iontext-e.pdf

Require that records be maintained of all disposal activities to document compliance.

Incorporate appropriate monitoring and continuous improvement mechanisms.

Specify the process for managing the transportation and potential international shipment of hazardous waste for disposal, if applicable . If the international disposal of hazardous waste

is to be conducted by a third party , the Request for Proposal (RFP) for these third-party services

for the international shipment must be approved by the GH NCOR with concurrence by the GH

BEO. Solicitation of services for international exportation of hazardous material for disposal

may not be initiated without approval of the RFP.

pg. 1 May 2018