GH-23-11012_IEE_INTEGRATE Project.pdf

INITIAL ENVIRONMENTAL

EXAMINATION

PROJECT/ACTIVITY DATA

Project/Activity Name: INTEGRATE

Geographic Location(s) (Country/Region): Global

Amendment (Yes/No), if Yes indicate # (1, 2...): No

Implementation Start/End Date (FY or M/D/Y): Oct 1, 2025 to Sept 30, 2030 Projects and activities that commence within this initial time frame may proceed for the duration of the proposed activities.

If Amended, specify New End Date:

Solicitation/Contract/Award Number(s): N/A

Implementing Partner(s):

Bureau Tracking ID: GH-23-11012

Tracking ID of Related RCE/IEE (if any): N/A

Tracking ID of Other, Related Analyses: N/A

ORGANIZATIONAL/ADMINISTRATIVE DATA

Implementing Operating Unit(s):

(e.g. Mission or Bureau or Office)

USAID/GH/OHA

Other Affected Operating Unit(s): GH/ID, AFR, ASIA, Lead BEO Bureau: GH

Funding Account(s) (if available):

Original Funding Amount:

If Amended, specify funding amount: N/A

If Amended, specify new funding total: N/A

Prepared by: Jessica Rodrigues

Date Prepared: 10/05/2023

ENVIRONMENTAL COMPLIANCE REVIEW DATA

Analysis Type: X Environmental Examination ☐Deferral

Environmental Determination(s): X Categorical Exclusion(s) X Negative (with conditions) ☐ Positive ☐ Deferred (per 22 CFR 216.3(a)(7)(iv)

IEE Expiration Date (if applicable): IEE may be subject to re-evaluation, or extended, after 5 years from the date of concurrence

Additional Analyses/Reporting Required: EMMPs and annual EMMRs

Climate Risks Identified (#): Low __8__ Moderate _14___ High ______

Climate Risks Addressed (#): Low __8__ Moderate _14___ High ______

THRESHOLD DETERMINATION AND SUMMARY OF FINDINGS

PROJECT/ACTIVITY SUMMARY

The purpose of the INTEGRATE Project is to contribute to sustaining the gains in the HIV response and enable pandemic preparedness and resilience in the face of other health threats by integrating current HIV systems for prevention, care, and treatment services into existing country health systems and primary health care platforms, in alignment with country priorities

The proposed mechanisms under INTEGRATE will provide critical financial and technical assistance to protect recent years’ investments gains and drive continued progress toward USAID’s global health goals of preventing child and maternal deaths and combating infectious diseases. Globally, achieving HIV epidemic control through integrated and resilient health systems and strengthening global health security are critical to achieving both of these goals. A core design feature of INTEGRATE is prepositioning technical expertise and resources that can be deployed to support communities and health facilities to integrate HIV prevention, care and treatment services into primary health care systems, to support the governance structures required to manage integrated health services, and to leverage existing HIV platforms and systems investments to encompass the prevention, detection, and response for other emerging health threats. Results and intermediate results are included in the table below:

Result 1:Improved integration of health services across community and facility settings for people living with HIV and individuals at risk of HIV acquisition or who could benefit from prevention services

Result 2: Improved health systems and governance structures for integrated HIV services within primary health care

Result 3: Improved public health systems to prevent, detect, and respond to HIV and other emerging epidemic threats

IR 1.1:Strengthened delivery of people-centered and simplified, integrated essential health services that include HIV services through the local primary health care system, at the community level, and the private sector, while supporting local governments to achieve and maintain

IR 2.1: Identification of bottlenecks and weaknesses of existing health systems that limit the ability to achieve sustainable epidemic control or better integrate services for clients

IR 3.1: Improved fiscal investment in surveillance and accountability that improves national surveillance for HIV and other diseases epidemic control.

IR 1.2: Increased implementation of integrated person-centered differentiated service delivery models that address the evolving and various needs of clients

IR 2.2:Improved health system capacity to provide HIV services integrated with primary healthcare

IR 3.2:Improved health systems capacity to mitigate the spread of public health threats

IR 1.3 Improved demand and utilization of quality services for HIV and individuals at risk of HIV acquisition

IR 2.3 Increased capacity of country-level systems to fund, implement, monitor, and sustain high-quality SBC interventions that address integrated essential health services

IR. 3.3: Increased local organizational capacity and expanded transformative partnerships to maintain, manage, use, and disseminate data & system analytics to inform program interventions in response to health threats

IR 2.4: Improved coordinated community and facility responses and services that address the holistic needs of people living with HIV and individuals at risk of HIV acquisition

The Initial Environmental Examination (IEE) and Climate Risk Assessment (CRM) for this project closely relate to and significantly draw from those that were conducted for Polio Eradication, Immunization and Post Eradication Transition Project GH-21-10599, and Amendment #1 of the NGO Polio Eradication Project PAD #REQ-GH-1700046, both of which are still current. Activities under this project carry threshold determinations of both Categorical Exclusion and Negative with Conditions. In line with the project’s logical framework, activities to be supported through INTEGRATE under Categorical Exclusion will include community mobilization, surveillance, and linkages between ongoing and routine HIV prevention, care and treatment and other health services; and liaising between community and government stakeholders on HIV and other health issues. Activities considered under Negative Determination with Conditions will include supporting the management of integrated HIV and broader health services and technical assistance for the proper disposal of hazardous medical waste.

TABLE 2: DEFINED OR ILLUSTRATIVE PROJECTS/ACTIVITIES AND SUB-ACTIVITIES

Activity objectives and illustrative activities and sub activities are included below:

Objective 1 — Support health facility and community sites to achieve or maintain sustained epidemic control through integrating HIV prevention, care and treatment services and related programs into the existing health system while strengthening primary health care systems

Activity 1.1: Planning and coordination with governments, local partners, community leaders and key stakeholders

Activity 1.2: Tool development to assess integration readiness and support transition to integration of HIV into primary health care

Activity 1.3: Strengthen, coordinate and decentralize drug distribution for ARVs, NCDs and other essential medications

Activity 1.4: Support SBC interventions to improve counseling, reduce stigma and measure client satisfaction with an integrated model of care

Activity 1.5: Conduct operational and formative research to inform and assess effectiveness of integrated service delivery

Objective 2 — Support systems-level activities and governance structures necessary for the design, administration, management, and technical implementation of integrated essential health services that include HIV services and related programs delivered through the local primary health care system

Activity 2.1: Provide technical assistance and leadership for integration of HIV into primary health care

Activity 2.2: Support integration of supply chain logistics (including electronic logistic management systems) and stock management of health commodities beyond those for HIV, to include other essential medications and diagnostics (i.e., self-test kits, glucose strips) for NCDs, family planning, COVID, STIs, VMMC, post-GBV care, and other community programming and PHC needs

Activity 2.3: Build upon PEPFAR-supported laboratory systems for HIV detection and management to strengthen integrated laboratory services that enhance primary health care, including laboratory diagnostic work on common platforms across disease states and emerging epidemic threats (e.g., TB, HPV, HIV/EID, COVID).

Activity 2.4 Integrate client health records systems, other HIV monitoring and evaluation tools and databases into the local information systems, including PHC QA/QI activities to eliminate disease-specific systems and records and promote client-centered data systems and monitoring

Activity 2.5 Support national HRH strategic planning, pre-service and in-service training to align the PEPFAR-supported health workforce with the local health workforce structure and upskill the PEPFAR-supported health workforce to provide other PHC services as a bridge towards a unified HRH system

Activity 2.6 Strengthen community health systems (planning, data and financing) and capacitate community health workforce to improve linkages between clinic and community health services and supporting social accountability focused on integration of HIV with other disease programs and services.

Objective 3 — Expand the reach of HIV services, platforms, and systems investments to encompass the prevention, detection, and response for other emerging epidemic threats

Activity 3.1: Expand partnerships to establish and provide ongoing support for an integrated public health surveillance system to identify HIV and other potential events of concern for public health security

Activity 3.2: Capacitate National Public Health Institutes to lead HIV/AIDS routine population-level surveillance and survey efforts to build national capacity to conduct HIV surveillance and other public health threats

Activity 3.3 Capacitate a multisectoral workforce to prevent, detect, and respond to public health threats, including infection prevention and control, RCCE, occupational health safety and security, and emergency response protocols in order to ensure continuity of HIV and other essential health services

Activity 3.4: Support infection prevention and control, health care acquired infections (HCAIs) surveillance, and safe environment in health facilities for HIV/TB and other HCAIs

Activity 3.5 Strengthen public health communications systems to effectively engage the public, through media, social media, mass awareness campaigns, health promotion, social mobilization, stakeholder engagement in the prevention, care and treatment of HIV and other public health threats.

ENVIRONMENTAL DETERMINATIONS

Upon approval of this document, the determinations below become affirmed as threshold decisions, and conditions become mandatory elements of the project implementation, per Agency regulations (22 CFR 216). In all other instances, all implementing partners under the INTEGRATE project shall promote and take all practicable steps to maximize adherence of the partners and interventions it works with to these points.

The most restrictive determination for the sum of the activities proposed under the INTEGRATE project is a Negative Determination, per 22 CFR 216.3 (a)(2)(iii), with conditions, indicating that the proposed actions will not have a significant effect on the environment, but that mitigating actions should be taken. Categories of activities proposed under the project are grouped below with their corresponding threshold determination, by potential environmental impact in section 3.0, along with the relevant mitigation conditions in section 5.0.

TABLE 1: ENVIRONMENTAL DETERMINATIONS

Activity Categories Categorical Exclusion Citation (if applicable)

Negative Determination

Positive Determination1

Deferral2

1.Interventions for education, technical assistance, and training 1a. Includes: Strategic planning, data analysis, technical consultations, surveys, development of guidelines, policies, and action plans, knowledge and information transfer, meetings, technical material development, outreach programs, and training services.

See activities 1.1, 1.2, 1.3, 1.4, 2.1, 2.4, 2.5, 2.6, 3.1, 3.2, 3.3, 3.4, 3.5

1b. Emerging

X

22CFR216.2(c)(i) Education, technical assistance, or training programs except to the extent such programs include activities directly affecting the environment

(such as construction of facilities, etc.);

(iii)Analyses, studies, academic or research workshops and

2 GH does not grant Deferrals during the IEE process. Deferrals must be cleared through an Amendment to this IEE prior to implementation of any deferred activities.

1 Positive Determinations require preparation of a Scoping Statement and Environmental Assessment.

threat/pandemic preparedness and surveillance including outbreak case investigation and response

See activities 3.1, 3.2, 3.3, 3.4, 3.5 1c. Cold chain and/or vaccine logistics system capacity strengthening through monitoring and reporting

See activities 2.2 and 2.3 meetings;

2. Interventions for procurement of healthcare and related commodities

See activities 2.1, 2.2, 2.3, 3.4

X ☐ ☐

3. Interventions resulting in the generation of healthcare or laboratory waste.

3a. HIV and integrated health service delivery and management support 3b. Logistics network support for transport and testing of specimens by reference labs

See activities 2.2, 2.3

X ☐ ☐

4. Interventions requiring small scale construction or rehabilitation of existing facilities.

See activity 3.4

X

5. Development research

See activity 1.5

X 22CFR216.2(c)(ii)

Controlled experimentation exclusively for the purpose of research and field evaluation which are confined to small areas and carefully monitored

CLIMATE RISK MANAGEMENT

As illustrated in the Climate Risk Management (CRM) screening matrices in Annex 1, this project may involve a range of potential negative climate impacts associated with both acute (event-driven) and chronic (long-term shifts) climate hazards. Climate risk ratings summarized in Annex 1 range from low to moderate levels. The climate risks described in these matrices are not intended to be exhaustive or definitive, but instead broadly illustrate relevant potential climate impacts that can negatively affect the proposed project development actions.

Considering the unknown scope and scale of project activities, a precautionary approach was adopted when assigning a climate risk level for each category. These risk assessments may be adjusted as needed when activity and geography details are more defined.

Opportunities:

Opportunities identified in Annex 1 address potential actions taken within and in coordination with the project for improving climate resilience for the particular project element. These are not required mitigation measures, but are high-level considerations for award design and adaptive management under this project. Examples include:

● Integrating National Adaptation and/or Health Security Plan objectives during designs.

Consider host government documentation of climate risks and adaptation strategies as they may identify areas for strengthening resilience. National Adaptation Plans may provide points of entry for strengthening health systems or addressing increased prevalence of disease vectors.

● Facilitating dialogues on climate change. During activity design, stakeholders should be engaged to understand which climate hazards are of greatest concern to them, and to inform integration of climate mitigation and adaptation measures into activity design, planning, monitoring, and adaptive implementations. Stakeholders may include Ministries of Environment, Agriculture, Health, and Finance; community-based organizations; private sector partners; and other donors.

● Contingency planning. Some climate risks must be accepted in order to achieve lifesaving project objectives, particularly in certain fragile, conflict-affected, and other vulnerable contexts. Activities under this project will foster climate resilient-design, to include scenario and contingency planning for extreme weather events. Planning may include documenting anticipating next steps if the activity cannot achieve a particular objective due to a climate-related event; exploring the potential to leverage insurance schemes; and costing of financial liabilities for health facilities in the event of damage to such events.

● Building flexibility into annual budgeting processes. Activities under this project, in consultation with all relevant stakeholders, will address the need to anticipate potential increases in operational and other costs due to climate events. Identifying savings through improved efficiencies in energy use may also build health system resilience capacities and free up some budget to absorb surge costs associated with responding to any unforeseen climate events.

● Aligning national waste management plans with activity planning. Many countries have drafted national waste management plans which would likely cover the activities planned under this project. At the same time, this project presents opportunities to refine existing waste management plans and to ensure adequate waste management planning that encompasses the activities implemented with project funds as part of broader health systems strengthening and integration.

Numerous resources are available for implementing partners (IPs) to consult when developing CRM documentation requirements at the activity level:

● A critical resource used in identifying and assessing the climate risks is USAID’s Climate Risk Screening and Management Tool for strategy, project, and activity design.

● IPs are advised to consult previous CRMs to research common environmental concerns and solutions among health activities globally. IPs can utilize the USAID Environmental Compliance Database to search for USAID-approved CRMs.

● For technical guidance on environmentally sound design and management for USAID development activities, consult the USAID Sector Environmental Guidelines.

● The USAID Environmental Procedures and Climate Risk Management website contains detailed guidance and best-practice considerations for CRM to address climate impacts and improve the effectiveness and sustainability of USAID’s efforts.

● The USAID Environmental Compliance Budgeting Toolkit provides IPs with guidance on how to identify costs for environmental management tasks described in the Environmental Mitigation and Monitoring Plan (EMMP) and CRM, where required.

● Climatelinks is a global knowledge portal for those working at the intersection of climate change and international development.

Please see Annex 1 for detailed CRM analyses.

BEO SPECIFIED CONDITIONS OF APPROVAL

The BEO has advised that while the IEE and CRM reflect the approximately five-year period from October 1, 2025 to September 30, 2030, the BEO may review and request updates to the IEE and CRM analysis during Year 5.

Once awards are made, the BEO shall approve an Environmental Mitigation and Monitoring Plan (EMMP) for all relevant awards, as necessary, before significant programmatic implementation begins.

Buy-ins to the activity or project described in this IEE must follow Mission/Regional environmental procedures with respect to any additional supplemental environmental analysis and documentation and incorporate any specific Mission/Regional requirements or mitigation measures into the Scope of Work (SOW), as appropriate.

IMPLEMENTATION

In accordance with 22 CFR 216 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 3, 4, and 5 of the IEE, as well as any BEO Specified Conditions of Approval.

This IEE is valid through FY30. Projects and activities covered under this IEE may proceed for their entire proposed duration provided the project or activities commence within the five-year validity period and the activities remain in the scope of this IEE.

https://www.climatelinks.org/resources/climate-risk-screening-management-tool https://www.climatelinks.org/resources/climate-risk-screening-management-tool https://ecd.usaid.gov/ https://ecd.usaid.gov/ http://www.usaidgems.org/sectorGuidelines.htm https://www.usaid.gov/environmental-procedures/sectoral-environmental-social-best-practices/sector-environmental-guidelines-resources http://www.usaidgems.org/ https://www.usaid.gov/environmental-procedures/environmental-compliance-esdm-program-cycle/environmental-procedures-climate-risk-management http://www.fsnnetwork.org/sites/default/files/EnvBudgettingToolkit.pdf https://www.climatelinks.org/

This IEE may be subject to re-evaluation or modification to determine if the activities undertaken remain within the scope of the approved categorical exclusions. If no change of scope or significant environmental issues are identified during the initial 5-year validity period, this IEE may be extended without the need for a supplemental environmental analysis.

Missions, Bureaus, and Independent Offices that buy- into a GH mechanism covered under this IEE may use this IEE for compliance with 22 CFR 216; however, each Mission, Bureau, or Independent Office must follow their own procedures as required including determining the need to produce supplemental Mission-level environmental documentation.

USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATION

PROJECT NAME: INTEGRATE Project

Bureau Tracking ID: GH-23-11012

Approval:

Han Kang, Office of HIV/AIDS, Director [Required] Date

Clearance:

Carol Holtzman, Design Team Co-lead [as appropriate] Date

Clearance

Jessica Ejike, Design Team Co-lead [as appropriate] Date

Concurrence:

Dennis Durbin, USAID/GH Bureau Environmental Officer and Climate Integration Lead [required]

Date

DISTRIBUTION:

Global Health (ghcompliancesupport@usaid.gov)

Environmental Compliance Database (environmentalcompliancesupport@usaid.gov)

1/2/2024

1/2/2024 jclinkscales Underline

INITIAL ENVIRONMENTAL

EXAMINATION

CONTENTS

1.0 PROJECT/ACTIVITY DESCRIPTION 5

1.1 PURPOSE OF the IEE 5

1.2 PROJECT/ACTIVITY OVERVIEW 5

1.3 PROJECT/ACTIVITY DESCRIPTION 5

2.0 BASELINE ENVIRONMENTAL INFORMATION 6

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT,

PHYSICAL, CLIMATE, SOCIAL, Threatened and ENDANGERED species) 6

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER

INTERNATIONAL STANDARDS (E.G. WHO), ENVIRONMENTAL AND SOCIAL LAWS,

POLICIES, AND REGULATIONS 6

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK 7

4.0 ENVIRONMENTAL DETERMINATIONS 7

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS 7

4.2 CLIMATE RISK MANAGEMENT 7

5.0 CONDITIONS AND MITIGATION MEASURES 8

5.1 CONDITIONS 8

5.2 AGENCY CONDITIONS 9

5.3 MITIGATION MEASURES 10

6.0 LIMITATIONS OF THIS INITIAL ENVIRONMENTAL EXAMINATION 11

7.0 REVISIONS 12

ANNEXES:

ANNEX 1: ACTIVITY CLIMATE RISK MANAGEMENT SUMMARY MATRICES 26

ANNEX 2: REFERENCES AND RESOURCES 30

ANNEX 3: ENVIRONMENTAL MONITORING AND MITIGATION REPORT (EMMR) 31

1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE OF THE IEE

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 USAID intervention described herein and recommend determinations and, as appropriate, conditions, for these activities. Upon approval, these determinations become affirmed, and specified conditions become mandatory obligations of implementation.

This IEE also documents the results of the Climate Risk Management process in accordance with USAID policy (specifically, ADS 201mal).

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

1.2 PROJECT OVERVIEW

The purpose of the INTEGRATE Project is to contribute to sustaining the gains in the HIV response and enable pandemic preparedness and resilience in the face of other health threats by integrating current HIV systems for prevention, care, and treatment services into existing country health systems and primary health care platforms, in alignment with country priorities.

The proposed mechanisms under INTEGRATE will provide critical financial and technical assistance to protect recent years’ investments gains and drive continued progress toward USAID’s global health goals of preventing child and maternal deaths and combating infectious diseases. Globally, achieving HIV epidemic control through integrated and resilient health systems and strengthening global health security are critical to achieving both of these goals. A core design feature of INTEGRATE is prepositioning technical expertise and resources that can be deployed to support communities and health facilities to integrate HIV prevention, care and treatment services into primary health care systems and to support the governance structures required to manage integrated health services and to leverage existing HIV platforms and systems investments to encompass the prevention, detection, and response for other emerging health threats.

1.3 PROJECT DESCRIPTION

Inputs for the INTEGRATE project will include financial and technical assistance to protect recent years’ investments gains and drive continued progress toward USAID’s global health goals of preventing child and maternal deaths and combating infectious diseases. Globally, achieving HIV epidemic control through integrated and resilient health systems and strengthening global health security are critical to achieving both of these goals. A core design feature of INTEGRATE is prepositioning technical expertise and resources that can be deployed to support communities and health facilities to integrate HIV prevention, care and treatment services into primary health care systems, to support the governance structures required to manage integrated health services, and to leverage existing HIV platforms and systems investments to encompass the prevention, detection, and response for other emerging health threats. Results and intermediate results are described below:

https://www.usaid.gov/our_work/environment/compliance/22cfr216 https://www.usaid.gov/ads/policy/200/201mal

Result 1:Improved integration of health services across community and facility settings for people living with HIV and individuals at risk of HIV acquisition or who could benefit from prevention services

Result 2: Improved health systems and governance structures for integrated HIV services within primary health care

Result 3: Improved public health systems to prevent, detect, and respond to HIV and other emerging epidemic threats

IR 1.1:Strengthened delivery of people-centered and simplified, integrated essential health services that include HIV services through the local primary health care system, at the community level, and the private sector, while supporting local governments to achieve and maintain epidemic control.

IR 2.1: Identification of bottlenecks and weaknesses of existing health systems that limit the ability to achieve sustainable epidemic control or better integrate services for clients

IR 3.1: Improved fiscal investment in surveillance and accountability that improves national surveillance for HIV and other diseases

IR 1.2: Increased implementation of integrated person-centered differentiated service delivery models that address the evolving and various needs of clients

IR 2.2:Improved health system capacity to provide HIV services integrated with primary healthcare

IR 3.2:Improved health systems capacity to mitigate the spread of public health threats

IR 1.3 Improved demand and utilization of quality services for HIV and individuals at risk of HIV acquisition

IR 2.3 Increased capacity of country-level systems to fund, implement, monitor, and sustain high-quality SBC interventions that address integrated essential health services

IR. 3.3: Increased local organizational capacity and expanded transformative partnerships to maintain, manage, use, and disseminate data & system analytics to inform program interventions in response to emerging threats

IR 2.4: Improved coordinated community and facility responses and services that address the holistic needs of people living with HIV and individuals at risk of HIV acquisition

TABLE 2: ILLUSTRATIVE ACTIVITIES AND ACTIVITY CATEGORIES

Objective 1 — Support health facility and community sites to achieve or maintain sustained epidemic control through integrating HIV prevention, care and treatment services and related programs into the existing health system while strengthening primary health care systems

Activity 1.1: Planning and coordination with governments, local partners, community leaders and key stakeholders

Activity 1.2: Tool development to assess integration readiness and support transition to integration of HIV into primary health care

Activity 1.3: Strengthen, coordinate and decentralize drug distribution for ARVs, NCDs and other essential medications

Activity 1.4: Support SBC interventions to improve counseling, reduce stigma and measure client satisfaction with an integrated model of care

Activity 1.5: Conduct operational and formative research to inform and assess effectiveness of integrated service delivery

Objective 2 — Support systems-level activities and governance structures necessary for the design, administration, management, and technical implementation of integrated essential health services that include HIV services and related programs delivered through the local primary health care system

Activity 2.1: Provide technical assistance and leadership for integration of HIV into primary health care

Activity 2.2: Support integration of supply chain logistics (including electronic logistic management systems) and stock management of health commodities beyond those for HIV, to include other essential medications and diagnostics (i.e., self-test kits, glucose strips) for NCDs, family planning, COVID, STIs, VMMC, post-GBV care, and other community programming and PHC needs

Activity 2.3: Build upon PEPFAR-supported laboratory systems for HIV detection and management to strengthen integrated laboratory services that enhance primary health care, including laboratory diagnostic work on common platforms across disease states and emerging epidemic threats (e.g., TB, HPV, HIV/EID, COVID).

Activity 2.4 Integrate client health records systems, other HIV monitoring and evaluation tools and databases into the local information systems, including PHC QA/QI activities to eliminate disease-specific systems and records and promote client-centered data systems and monitoring

Activity 2.5 Support national HRH strategic planning, pre-service and in-service training to align the PEPFAR-supported health workforce with the local health workforce structure and upskill the PEPFAR-supported health workforce to provide other PHC services as a bridge towards a unified HRH system

Activity 2.6 Strengthen community health systems (planning, data and financing) and capacitate community health workforce to improve linkages between clinic and community health services and supporting social accountability focused on integration of HIV with other disease programs and services.

Objective 3 — Expand the reach of HIV services, platforms, and systems investments to encompass the prevention, detection, and response for other emerging epidemic threats

Activity 3.1: Expand partnerships to establish and provide ongoing support for an integrated public health surveillance system to identify HIV and other potential events of concern for public health security

Activity 3.2: Capacitate National Public Health Institutes to lead HIV/AIDS routine population-level surveillance and survey efforts to build national capacity to conduct HIV surveillance and other public health threats

Activity 3.3 Capacitate a multisectoral workforce to prevent, detect, and respond to public health threats, including infection prevention and control, RCCE, occupational health safety and security, and emergency response protocols in order to ensure continuity of HIV and other essential health services

Activity 3.4: Support infection prevention and control, health care acquired infections (HCAIs) surveillance, and safe environment in health facilities for HIV/TB and other HCAIs

Activity 3.5 Strengthen public health communications systems to effectively engage the public, through media, social media, mass awareness campaigns, health promotion, social mobilization, stakeholder engagement in the prevention, care and treatment of HIV and other public health threats.

The proposed activities will involve activity categories that will have an environmental impact including: 1) procurement of healthcare and related commodities, 2) healthcare delivery or analysis services that may generate healthcare waste, and 3) small scale construction. These activity categories will require mitigation measures outlined in section 5.0. Mitigation measures and will be further refined in the environmental mitigation and monitoring plan.

The proposed interventions may also include technical assistance, education, analysis, and research actions that are categorically excluded.

Will this project involve construction3 as defined by ADS 201 and 303? Yes x No

2.0 BASELINE ENVIRONMENTAL INFORMATION

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT, PHYSICAL,

CLIMATE, SOCIAL, THREATENED AND ENDANGERED SPECIES)

Missions and their respective Bureaus can buy-in to the global INTEGRATE mechanism and are responsible for preparing any supplemental environmental documentation. Activities under the INTEGRATE Project may be implemented in any countries with USAID missions or in countries covered by USAID regional missions. Environmental procedures are detailed in relevant national policies. Applicable country and environmental information will be detailed for each country activity in the Request for Application document, where applicable for completed awards.

Activities may take place in a range of locations, from family homes and to established public and private sector urban and rural health facilities. That said, all initiatives associated with project activities are to take place in established dwellings and are not expected to have significant environmental impact should all conditions be met. Target population access issues due to poor infrastructure, security issues, community mistrust, limited government involvement, voluntary and forced migration, harsh weather conditions, and extreme weather events are all anticipated in many locations under this project. Transportation for project purposes will involve use of existing roads and other travel routes; new construction or rehabilitation of roads or facilities will not occur under this project. Where applicable for an Implementing Partner, the EMMP will ensure compliance of project activities with all applicable country laws.

Changes in the baseline conditions of operating locations due to climate change are not expected to be significant over the life of the project, though shifts in epidemiologic patterns may begin to occur and impact services provided.

3 Construction, as defined by ADS 201 and 303, includes: construction, alteration, or repair (including dredging and excavation) of buildings, structures, or other real property and includes, without limitation, improvements, renovation, alteration and refurbishment. The term includes, without limitation, roads, power plants, buildings, bridges, water treatment facilities, and vertical structures. In the box below, describe any construction planned for this project/activity. Refer to ADS 201maw for required Construction Risk Management procedures.

https://www.usaid.gov/sites/default/files/documents/1865/201maw.pdf

Per 22 CFR 216.5 USAID must ensure its assistance programs do not negatively impact threatened or critically endangered species or their habitats. Due to the global nature of this PAD, it is not possible to make a determination at this time about activity impact. Once activities are further refined, an assessment and determination will be made to ensure minimal impact on the environment in order to protect these species. Any action that is likely to adversely impact threatened or endangered species or their critical habitat will require additional environmental review.

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL

STANDARDS (E.G. WHO), ENVIRONMENTAL AND SOCIAL LAWS, POLICIES, AND REGULATIONS

As appropriate, awards will work with facility, local, regional, and/or national officials, to implement and apply appropriate best management practices which incorporate appropriate health and safety measures and environmental safeguards, including proper disposal of medical waste in accordance with international norms as described by WHO in "WHO's Safe Management of Wastes from Healthcare Activities."

National policies and laws shall also be considered, though most countries follow WHO Guidelines. Countries in which the project will work will be determined after each award, and context-specific considerations will be included in country-specific EMMPs (as an annex to the country workplan), where applicable, including considerations regarding the capacity of local governmental and non-governmental organizations to implement applicable permit requirements, policies, laws and regulations.

The status of country level environmental policies, standards, laws, and regulations vary by country. The final country selection for this project has not yet been made, so this baseline information is not yet available. The appropriate international standard is listed in the mitigation plan. Here is a summary of relevant standards:

● USAID: Healthcare Waste (2019)

● USAID: Integrated Waste Management Plan (IWMP) (2022)

● WHO: Safe management of waste from health-care activities

● WHO: Laboratory Biosafety Manual- Fourth Edition (2020)

● CDC and NIH: Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th

● Edition (2020)

● U.S. National Institute of Health: NCCIH Clinical Research Toolbox (2020)

● Guidelines of the American Society of Mammalogists for the use of wild mammals in

● research (2011)

● USAID Sector Environmental Guidelines: Construction (2017)

● ENCAP Visual Field Guide: Construction for quick identification of serious environmental & occupational health and safety concerns in small-scale construction.

2.3 COUNTRY/MINISTRY/MUNICIPALITY ENVIRONMENTAL CAPACITY ANALYSIS (AS

APPROPRIATE)

N/A https://www.usaid.gov/environmental-procedures/sectoral-environmental-social-best-practices/seg-healthcare-waste/pdf https://www.usaid.gov/documents/1865/integrated-waste-management-plan-iwmp https://www.who.int/publications/i/item/9789241548564 https://www.who.int/publications/i/item/9789240011311 https://www.cdc.gov/labs/BMBL.html https://www.nccih.nih.gov/grants/toolbox https://academic.oup.com/jmammal/article/97/3/663/2459909 https://academic.oup.com/jmammal/article/97/3/663/2459909 https://www.usaid.gov/environmental-procedures/sectoral-environmental-social-best-practices/seg-construction/pdf https://www.usaid.gov/sites/default/files/documents/1860/ENCAP_VFG-Construction_Dec2011.pdf https://www.usaid.gov/sites/default/files/documents/1860/ENCAP_VFG-Construction_Dec2011.pdf

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

The activities under this award 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. Activities that are categorically excluded do not need further analysis or reporting, other than an annual review, to ensure the scope of work has remained under the terms of a categorical exclusion. 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 (such as hazardous and infectious waste management) into health service delivery systems.

Certain activities supported may directly or indirectly affect the environment, or have the potential to do so. Based on analyses conducted by the AOR, these activities could affect the environment in the following ways:

1. Activities that directly or indirectly cause the procurement, storage, management and disposal of public health commodities, including vaccines, laboratory supplies, and reagents;

2. Activities, such as provision of healthcare services, that directly or indirectly result in the generation and disposal of hazardous or highly hazardous waste or in techniques that have a direct or indirect environmental impact;

3. Activities related to small-scale, non-structural rehabilitation; and

Each of these potential impacts is discussed in detail below. Categorically excluded activities with a de minimis impact are not included.

PROJECT: INTEGRATE

TABLE 3A. POTENTIAL PROJECT IMPACTS

Activity categories Potential environmental and social impacts

1.Interventions for education, technical assistance, and training 1a. Includes: Strategic planning, data analysis, technical consultations, surveys, development of guidelines, policies, and action plans, knowledge and information transfer, meetings, technical material development, outreach programs, and training services.

See activities 1.1, 1.2, 1.3, 1.4, 2.1, 2.4, 2.5, 2.6, 3.1, 3.2, 3.3, 3.4, 3.5

1b. Emerging threat/pandemic preparedness and

22CFR216.2(c)(i) Education, technical assistance, or training programs except to the extent such programs include activities directly affecting the environment (such as construction of facilities, etc.);

(iii)Analyses, studies, academic or research workshops and meetings surveillance including outbreak case investigation and response

See activities 3.1, 3.2, 3.3, 3.4, 3.5 1c. Cold chain and/or vaccine logistics system capacity strengthening through monitoring and reporting

See activities 2.2 and 2.3

2. Interventions for procurement of healthcare and related commodities

See activities 2.1, 2.2, 2.3, 3.4

Procurement:

Pharmaceuticals are chemicals used for diagnosis, treatment (cure/mitigation), alteration, or prevention of disease, health condition, or structure/function of the human body. Pharmaceuticals, including vaccines, have specific storage time and temperature requirements and may expire before they can be used, particularly in remote areas.

Pharmaceutical waste may also accumulate due to inadequacies in stock management and distribution and lack of a routine system of disposal. The effects of pharmaceuticals in the environment are different from conventional pollutants.

Procurement or acceptance of donated PHC that are defective, expired, or counterfeit may lead to public health impacts due to the potential of these PHC being unsafe and/or ineffective if used by consumers. Adverse health and environmental impacts may also occur if defective, expired, or counterfeit PHC are not properly managed and treated and/or disposed.

Pharmaceuticals are designed to interact within the body at low concentrations to elicit specific biological effects in humans, which may cause biological responses in other organisms. Their main pathway into the environment is through household use and excretion, and through the disposal of unused or expired pharmaceuticals.

Effects on aquatic life are a major concern in disposal of pharmaceuticals. A wide range of pharmaceuticals have been discovered in fresh and marine waters globally, and even in small quantities some of these compounds have the potential to cause harm to aquatic life. Exposure risks for aquatic organisms are much larger than those for humans, because aquatic organisms have continual (and multi-generational) exposures, exposures to higher concentrations, and possible low-dose effects. Traditional environmental toxicology focuses on the acute effects of concentrated exposures, rather than on the chronic effects of low-level exposures.

Measured toxicities of some tested pharmaceuticals have shown that the acute effects of single substances in the aquatic environment is very unlikely.

However, effects of pharmaceuticals may be subtle because they occur in the environment in low concentrations. Some tests with combinations of various pharmaceuticals have revealed stronger effects than expected from the effects measured singly. More research is needed on combination effects, and chronic studies are needed to assess the environmental risk of drug residues. Certainly, pollution prevention (e.g., source elimination or minimization) is preferable to remediation or restoration to minimize both public cost and human/ecological exposure.

Antibiotics and undiluted disinfectants should not be disposed of into the sewage system as they may kill bacteria necessary for the treatment of sewage. Additional health risks related to disposal include burning pharmaceuticals and plastic medical supplies at low temperatures or in open containers, resulting in release of toxic pollutants into the air. Inefficient and insecure sorting and disposal may allow drugs beyond their expiry date to be diverted for resale to the general public. In some countries, scavenging in unprotected insecure landfills is a hazard.

Likewise, the mass procurement and distribution of commodities such as medicines and medical equipment have the potential to contribute to solid waste. Many countries do not have facilities to manage solid wastes other than uncontrolled burns. Plastics and other inorganic materials pose solid waste management issues for some countries.

Storage:

Improper storage of PHC can result in pharmaceuticals being damaged due to failure to meet storage condition requirements, theft through inadequate security, damage from pests, and hazards such as fire. Environmental and social impacts may result from damaged products getting into the environment or local community due to improper storage. In addition, equipment used to operate the storage facility (e.g., mobile equipment, chillers, HVAC systems, fuel storage tanks) should be properly maintained to prevent accidents or spills from occurring that may lead to health or environmental impacts.

Distribution:

Improper distribution and/or transportation of PHCs can result in reduction in PHC quality (e.g., damaged or defective supplies) through inadequate temperature or humidity controls. Environmental impacts may occur from the use of vehicles to distribute supplies (e.g., fuel operation, maintenance) or if an accident or spill occurs during transportation that releases commodities to the environment.

Unsecured vehicles can result in theft.

Waste Management:

Improper on-site handling, storage, and treatment and/or disposal of HCW may lead to adverse health and environmental impacts. Workers and others handling HCW may be in direct contact with hazardous waste during treatment and/or disposal activities, which could lead to health impacts. Treatment of HCW in an incinerator may lead to air pollution. Disposal of waste via landfilling may lead to leaching of hazardous waste into the soil and surrounding water sources. In addition, improperly managed or unsecured landfills may allow scavengers to collect untreated, disposed PHC for reuse (e.g., personal use, circulation in the community), which could result in health impacts.

Small-scale healthcare initiatives, such as rural health posts or clinics, mobile clinics, urban clinics and small hospitals, and community health workers and training in health workers provide important and often critical healthcare services to individuals and communities that would otherwise have little or no access to such services. These health workers working in these underserved contexts are the front line of defense against epidemics and a key component of any comprehensive health development program. The medical and health services they provide improve newborn, child, and maternal health, prevent disease, cure debilitating illnesses, and alleviate the suffering of the dying.

However, improper training, handling, storage and disposal of the waste generated in these facilities or activities can spread disease through several mechanisms. Transmission of disease through infectious waste is the greatest and most immediate threat from healthcare waste. If waste is not treated in a way that destroys the pathogenic organisms, dangerous quantities of microscopic disease-causing agents-viruses, bacteria, parasites or fungi will be present in the waste. These agents can enter the body through punctures and other breaks in the skin, mucous membranes in the mouth, by being inhaled into the lungs, being swallowed or being transmitted by a vector organism. Those who come in direct contact with the waste are at greatest risk. Examples 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. Although sharps pose an inherent physical hazard of cuts and punctures, the much greater threat comes from sharps that are also infectious waste. Healthcare workers, waste handlers, waste pickers, substance abusers, and others who handle sharps have become infected with HIV and/or hepatitis B and C viruses through pricks or reuse of syringes/needles.

Contamination of water supply from untreated healthcare waste can also have devastating effects. If infectious specimens or bodily fluids are not treated before being disposed of, they can create and extend epidemics. The absence of proper sterilization procedures is believed to have increased the severity and size of cholera epidemics in Africa during the last decade.

If the project's training activities for professional health workers or community health workers involve techniques that would generate and require disposal of hazardous or highly hazardous waste, the implementing partners shall be required to include training in or ensure that the training curriculum covers best management practices concerning…