J.3 Initial Environmental Examination (IEE).pdf

INITIAL ENVIRONMENTAL

EXAMINATION

PROJECT/ACTIVITY DATA

Activity Names: Next Generation Global Health Supply Chain Suite of Programs: In-country Logistics (NextGen ICL)

Geographic Location(s) (Country/Region): Global: Afghanistan, Angola, Bangladesh, Benin, Botswana, Burkina Faso, Burundi, Burma, Cambodia, Cameroon, Côte d'Ivoire, Dominican Republic, Colombia, D.R. Congo, Eswatini, Ethiopia, Ghana, Guatemala, Guinea, Guyana, Haiti, Honduras, India, Indonesia, Jamaica, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mozambique, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Peru, Philippines, Rwanda, Senegal, Sierra Leone, South Africa, South Sudan, Tanzania, Thailand, Togo, T&T, Uganda, Ukraine, Uganda, Venezuela, Vietnam, West Africa Region, Yemen, Zambia, Zimbabwe

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

No

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

2021 – 2026 (with extension for another 5 years until 2031 with GH BEO approval)

If Amended, specify New End Date:

Solicitation/Contract/Award Number(s): TBD Implementing Partner(s): TBD Multiple Bureau Tracking ID: GH-20-10413 Tracking ID of Related RCE/IEE (if any): PSA IEE – To be assigned

SCTA IEE - To be assigned Tracking ID of Other, Related Analyses: IVM MVC PEA https://ecd.usaid.gov/repository/pdf/496.pdf

Fumigation PEA https://www.usaid.gov/documents/1860/pea-t-3-template-fumigation-management-plan

Covid-19 PIEE https://ecd.usaid.gov/document.php?doc_id=52754 https://ecd.usaid.gov/repository/pdf/50485.pdf

ORGANIZATIONAL/ADMINISTRATIVE DATA

Implementing Operating Unit(s):

(e.g. Mission or Bureau or Office)

GH/ID/MAL, MCHN, OHA/SCH, OHS, PRH/CSL

NEXTGEN: IN-COUNTRY LOGISTICS

SBU-PROCUREMENT SENSITIVE

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Other Affected Operating Unit(s):

Lead BEO Bureau: Global Health (GH) Funding Account(s) (if available):

Total Estimated Cost/Amount Range: ~$1.48 billion USD If Amended, specify funding amount:

If Amended, specify new funding total:

Prepared by: A Neigh, ECOS Date Prepared: June 2020

ENVIRONMENTAL COMPLIANCE REVIEW DATA

Analysis Type: Environmental Examination Deferral Environmental Determination(s): Categorical Exclusion(s)

Negative Positive Deferred (per 22 CFR 216.3(a)(7)(iv)

IEE Expiration Date (if applicable): Sept 1, 2026 (eligible for a 5 year amendment with approval by the GH BEO)

Additional Analyses/Reporting Required: EMMP; PERSUAP; WMP Climate Risks Identified (#): Low ___0___ Moderate ___5___ High ___5___ Climate Risks Addressed (#): Low ___0___ Moderate ___5___ High ___5___ iii

THRESHOLD DETERMINATION AND SUMMARY OF FINDINGS

PROJECT SUMMARY

The objective of the Next Generation Global Health Supply Chain Suite of Programs (NextGen) is to establish and operate high performing and agile supply chains that ensure the procurement and delivery of affordable, high-quality, essential, and life-saving health commodities. NextGen will support the U.S. Government’s (USG’s) global health priorities to prevent child and maternal deaths, control the HIV/AIDS epidemic, eradicate malaria, and combat infectious diseases through the procurement and delivery of health commodities. NextGen is committed to responding to unique requirements of each health program, identifying where to segment functions to maximize performance and respond to different program requirements, and developing a program that attracts reputable commodities providers and increases accountability. NextGen emphasizes strengthening supply chains in USAID-supported countries through investment in building country commitment and capacity of systems responsible for procurement, storage, distribution, dispensing and related supply chain services to ensure longevity and self-reliance in the absence of foreign assistance.

The NextGen planned awards are:

1. Procurement Service Agent HIV Pharma (NextGen PSA HIV Pharma)

This award will provide procurement and associated supply chain services for HIV/AIDS health commodities excluding HIV/AIDS diagnostic and lab commodities encompassing the required procurement functions of a supply chain (e.g., category management, strategic sourcing, supplier management, demand planning and procurement delivery). The PSA will negotiate incoterms with vendors for delivery of commodities into country, and, in exceptional cases, procure logistics services for commodities purchased under this award to ensure timely delivery.

The awardee must coordinate with other awardees under the program.

2. Procurement Service Agent Malaria (NextGen PSA Malaria)

This award will provide procurement and supply chain services for malaria health commodities.

It will encompass different services within the procurement as-a-service value chain (e.g., category management, strategic sourcing, supplier management, transactional procurement and demand planning). It will provide a robust information system to support operations and performance improvement. The PSA will negotiate incoterms with vendors for delivery of commodities to country, and as needed, provide freight and warehousing for commodities purchased under this award. The awardee must coordinate with other awardees under the program.

3. Procurement & Logistics Services - Family Planning and Reproductive Health (FP/RH), Maternal and Child Health and Nutrition (MCHN), Other Health Elements (Next Gen PLS) iv

This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for family planning and reproductive health and other health commodities

4. Procurement Service Agent Lab, Diagnostics, and Molecular (NextGen PSA Diagnostics)

This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for HIV/AIDS lab, diagnostic and molecular commodities.

5. In-country Logistics (NextGen ICL) One or more awards will provide for in-country logistics and delivery of NextGen commodities.

6. Control Tower for USAID Next Generation Global Health Supply Chain Suite of Programs (NextGen CT)

This award will provide a central hub to provide end-to-end visibility and specific and cross-program information for Missions, Bureaus, Agency leadership and program managers of commodities procured through NextGen.

7. Qualifying Testing Issuing (NextGen QuTI) This award will serve as the primary vehicle to help assure the quality of health commodities purchased under NexGen and other global health programs.

8. Risk Management and Mitigation (NextGen RMM) One or more awards will identify and mitigate supply chain vulnerabilities and potential risks both globally and locally, including fraud, abuse and/or misuse, counterfeit, and diversion of products and financial resources. It will also verify second- and third-tier suppliers and other vendors subcontracted under other NextGen awards to improve supply chain integrity and security.

9. Supply Chain Technical Assistance (NextGen SCTA) One or more awards will provide a comprehensive array of technical assistance (TA) services to improve operational excellence in country supply chains and improve the availability of health commodities to meet the needs of today’s populations and support countries on their journeys to self-reliance to meet the needs of tomorrow’s populations. TA investments could include supporting and strengthening warehousing, distribution, quantification, forecasting, procurement, transportation, and information systems with the mandate to achieve country-led and -managed supply chain systems. The award(s) will provide support to refocus the role of country governments from supply chain operators to stewards of product availability and security. This includes leveraging the broader landscape of country capacities, including increased use of private sector, to improve supply chain performance and client experience.

v

10. Public Private Partnerships (NextGen PPP) One or more awards will support public private partnerships focused on leveraging private sector expertise to strengthen health systems as it relates to procurement, logistic, supply chain, data sharing, airtime, and strategic marketing expertise, in partnership with central and/or country programs.

ACTIVITY SUMMARY

This Initial Environmental Examination (IEE) (summarized below) covers the In-country Logistics (NextGen ICL) award which will be tasked with the direct management of warehousing, distribution and transportation operations that are deemed necessary by GH because of a lack of host-government logistics capacity. NextGen ICL is implemented through in-country service providers themselves as well as directly through sub-contracted in-country service providers or directly through the awardee itself. NextGen ICL will not be procuring commodities, but takes temporary custody of commodities from other entities for transportation and in rare occasions, may take custody from non-USG entities.

Sub-activities generally fall within a set of illustrative activities for NextGen ICL, including:

Logistic system design. The contractors will establish a structured transportation and warehousing strategy, including storage and transport cost considerations, on-time delivery, and delivery mode options. The contractors will maintain a network of collaborating in-country logistics services providers capable of providing services such as, but not limited to, custom’s clearance, bonded warehousing and in-country transportation services.

Sub-contracting for in-country suppliers. Contractors are to negotiate and award agreements with in-country suppliers of warehousing, distribution and transportation services for the storage and delivery of its funded commodity distributions.

Order fulfillment. Contractors, will provide order fulfillment including picking, packing, and order assembly for transport and warehousing at lower level medical stores and delivery points.

Direct warehousing and transport of commodities. Contractors, as directed by the USAID Contracting Officer’s Representative (COR), will warehouse and transport health commodities, according to agreed upon delivery times, and between designated points of origin to a single and multiple destination within a USAID focus country.

Data management and supply chain oversight. Contractors will establish continuous improvement processes and procedures and provide data on the management of commodities either being stored, transported, or having been delivered.

Recall and waste management assistance. The contractor will assist with the logistics required of any recalls for products that are procured by other USG Agencies, partner countries organizations, implementing partners and/or donors and ensure that appropriate policies and procedures are in place to manage waste and treatment and/or disposal of expired/damaged product.

Customs and importation support. Contractors will support obtention of importation waivers and facilitate the clearance and delivery of USG-procured commodities as vi necessary. Contractors will provide support, when requested, for customs clearance, warehousing and transport of health commodities neither being procured by the USG or being shipped to a warehouse under the provider.

Procurement, assembly, or construction. Although unlikely, USAID may be asked to provide emergency funding to support procurement and construction of in-country logistics infrastructure. These instances would be the result of natural disasters flooding, typhons, etc., political unrest and other Act of God that causes widespread damage to in-country infrastructure and create a situation that overwhelms a local company’s financial capabilities and or ability to secure commercial financing. In these instances, USAID may decide to provide funding to our partners to construct infrastructure to ensure they can continue to receive, store and deliver critical health care commodities.

The contractors are required to comply with specific contractual standards to ensure best practices and best value for provision of services under NextGen ICL. The commodities transported or warehoused by NextGen ICL that were procured through NextGen will meet global quality standards, e.g. World Health Organization Prequalification Programme (WHO- PQ) listing, and local regulatory requirements (e.g., registration).

The specified health commodities that NextGen ICL may be handling include those supplied under the USAID PSA awards, but also may include commodities procured or under the control of local Ministries of Health (MoH). NextGen ICL will not be procuring any of these commodities but may take temporary control over the commodities during warehousing or transport or assist with recalls and waste management. The best in class provider would be expected to have appropriate infrastructure in place to be awarded the contract. If they need to make improvements to meet USAID contract requirements, they would be expected to use their own funds or secure commercial financing to bring facilities up to standard for managing commodities.

Commodities handled by the contractors may include but are not limited to the following:

Antiretrovirals (ARVs) Essential medicines Food by prescription (FBP) and ready-to-use therapeutic foods (RUTFs) Male and female condoms and personal lubricants Voluntary medical male circumcision (VMMC) kits Laboratory supplies Intrauterine devices (IUDs)

Insecticide treated nets (ITNs) Rapid diagnostic tests (RDTs)

Malaria treatment drugs (artemisinin-based combination therapy (ACTs), sulfadoxine-pyrimethamine + amodiaquine [SPAQ]) Medicines to prevent and treat tuberculosis (TB) Medicines to prevent and treat opportunistic infections Anti-infective medicines Hormonal contraceptives Medical supplies (gloves, gowns, etc.)

Medical equipment (hospital beds, etc.)

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The NextGen ICL award, in its design, is focused on coordinating and delivering commodities in a reliable, cost efficient, and timely manner. These objectives reduce inefficiencies and ensure local delivery of commodities when and where they are needed. The support for movement of the commodities will help to avoid overstocking, expiration, or change in regimes issues that might commonly result in the need to transport, treat, and/or dispose of commodities. Services will adopt or use in-country Global Standard 1 (GS1) to reinforce regulatory compliance and improve traceability and expand commodity visibility (e.g., through use of barcodes).

ENVIRONMENTAL DETERMINATIONS

Upon approval of this document, the determinations become affirmed, per Agency regulations (22 Code of Federal Regulations [CFR] 216). For the purposes of environmental review in this IEE, the illustrative activities of the NextGen ICL awards are grouped into the following intervention categories.

TABLE 1: ASSIGNED INTERVENTION CATEGORIES AND ENVIRONMENTAL DETERMINATIONS

Intervention Categories/Sub-activities

Categorical Exclusion Citation (if applicable)

Negative Determination

Positive Determination1

Deferral2

Intervention Category 1: Administrative and IT Support, Data Analysis, Assessments, Surveys, and System Design Sub-activity 1.1: Office establishment, country office set-up, award kick-off activities, general office activities

§216.2(c)(2)(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.)

Sub-activity 1.2:

Establishment of supply chain information technology (IT), data management, and monitoring systems

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

Sub-activity 1.3: Sub-contractor management for transport and warehousing (contract administration, chain of custody management, invoicing, receipt reconciliation)

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

Sub-activity 1.4: Technical assessments (e.g., investigate and address leakage and diversions;

spending analysis and cost-

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

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

2 GH does not grant Deferrals for projects during the IEE Process.

viii effectiveness evaluations) Intervention Category 2: Technical Assistance (TA), Training, and Information Sharing Sub-activity 2.1:

Participation in strategy development and planning (i.e., campaigns, resupply, distributions, routing and timing)

§216.2(c)(2)(viii) Programs involving nutrition, health care or family planning and reproductive health care except to the extent designed to include activities directly affecting the environment (such as construction of facilities, water supply systems, wastewater treatment, etc.)

Sub-activity 2.2: Information sharing with other activities, host country authorities (e.g., demonstrating and sharing new logistical approaches)

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

Sub-activity 2.3:

Consultations, meetings, workshops, and coordination with other partners

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

Sub-activity 2.4: Participate in planning for phase in and phase out

§216.2(c)(2)(viii) Programs involving nutrition, health care or family planning and reproductive health care except to the extent designed to include activities directly affecting the environment (such as construction of facilities, water supply systems, wastewater treatment, etc.)

Sub-activity 2.5: Participate in adaptation planning given shocks and emergencies

§216.2(c)(2)(xiv) Studies, projects or programs intended to develop the capability of recipient countries to engage in development planning, except to the extent designed to result in activities directly affecting the environment (such as construction of facilities, etc.)

Sub-activity 2.6: Participate §216.2(c)(2)(xiv) ix in exercises on alternative distribution models

Studies, projects or programs intended to develop the capability of recipient countries to engage in development planning, except to the extent designed to result in activities directly affecting the environment (such as construction of facilities, etc.)

Intervention Category 3: Commodities Inventory Management Sub-activity 3.1: Identify and pre-qualify service providers

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

Sub-activity 3.2: Establish and monitor inventories and document shelf-life

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

Intervention Category 4: Quality Control – Management of Expired, Off-specification, Recalled, Damaged, or Mishandled Product Management of expired, off-specification, recalled, damaged, or other mishandled commodities (sub-activity based on USAID’s level of control)

Sub-activity 4.1: In possession of NextGen ICL contractor with specified conditions

Sub-activity 4.2: In possession of NextGen ICL sub-contractor (transport or warehousing agent) with specified conditions

Sub-activity 4.3: In possession of MoH, but NextGen ICL contractor requested to assist with specified conditions

Intervention Category 5: Commodities Shipping and Freight Management Shipping or freight management of commodities (sub-activity based on USAID’s level of control) Sub-activity 5.1: Directly by NextGen ICL contractor with specified conditions Sub-activity 5.2: Through NextGen ICL subcontractor network with specified conditions

Intervention Category 6:Storage in Warehouses/Distribution Centers Storage management (sub-activity based on USAID’s level of control) Sub-activity 6.1: Through warehouse managed by with specified conditions Sub-activity 6.2: Through warehouse leased or subcontracted but not managed by NextGen ICL with specified conditions

Intervention Category 7: Pesticide Transport and Storage or Control in Warehouses, Ports, Storage Sites, Shipping Facilities Sub-activity 7.1: Contracting x of services directly for pest control – including fumigation, rodent control with specified conditions

Sub-activity 7.2: Pest control provided as part of a service/warehousing contract with specified conditions

Sub-activity 7.3: Transport, handling and storage of pesticides with specified conditions

Intervention Category 8: Construction and/or Rehabilitation of Warehouses, Storage Sites, Shipping Facilities Sub-activity 8.1:

Construction/refurbishment of storage/warehouse units with specified conditions

Sub-activity 8.2 Environmental compliance documentation and/or permitting support

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

Sub-activity 8.3 Procurement of prefabricated structures (e.g., warehouse in a box, clinic in a box) with specified conditions

Sub-activity 8.4 Assembly of prefabricated structures with specified conditions Sub-activity 8.5 Water and electricity utility connections with specified conditions Sub-activity 8.6 Site preparation for structures with specified conditions

CLIMATE RISK MANAGEMENT

This screening is required per the Mandatory Reference for Automated Directives System (ADS) Chapter 201: Climate Risks Management (CRM) for USAID Projects and Activities.3 A project-level CRM was developed and approved in September 2019. At the time of drafting the CRM for these NextGen ICL activities, the activity’s details were still largely under development and the specific scopes of work for activities, including the location, duration, and other parameters determined by the availability of funding, have yet to be defined but could take place across more than 60 countries. The CRM summary presented here is intended to provide identify which elements of the project-level CRM apply to the NextGen ICL activities to help inform design and actionable approaches for addressing climate risks. The project-level CRM noted “Moderate” or “High” climate risks of sub-activities for the NextGen ICL awards. The CRM Summary Table is attached in Annex 1.

3 Climate Risk Management for USAID Projects and Activities. https://www.usaid.gov/ads/policy/200/201mal xi

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 and any Bureau Environmental Officer (BEO) Specified Conditions of Approval.

xii

USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATION

PROJECT/ACTIVITY NAME: NextGen: In-country Logistic Project (NextGen ICL)

Bureau Tracking ID: GH-20-10413

Approval: Email approval 11/2/20 Marita Eibl, Acting GH Deputy Assistant Administratorr Date

Approval: Email approval 10/30/20 Charles Pope, GH Chief of Operations Date

Clearance: Clearance by Email 10/29/20 James Maloney, Deputy Director, GH/OHA Date

Clearance: Clearance by Email 10/19/2020 Ellen Starbird, Director, GH/PRH Date

Clearance: Clearance by Email 09/24/2020 Julie Wallace, Director, GH/ID/MAL Date

Clearance: Clearance by Email 10/22/20 Carmen Tull, Deputy Director, GH/MCHN Date

Clearance:

Jennifer Slotnick, Acting Climate Integration Lead Date

Concurrence:

Jennifer Slotnick, Acting GH Bureau Environmental Officer Date

DISTRIBUTION:

Carol Chan Charles Pope Jed Meline James Maloney Ellen Starbird

Julie Wallace Kathrine Crawford Dennis Durbin Jan Miller Environmental Compliance Database

11/09/2020

11/09/2020

Jennifer Slotnick Digitally signed by Jennifer Slotnick Date: 2020.11.09 16:48:02 -05'00'

Jennifer Slotnick Digitally signed by Jennifer Slotnick Date: 2020.11.09 16:48:47 -05'00'

INITIAL ENVIRONMENTAL

EXAMINATION

CONTENTS

ACRONYMS

1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE OF THE INITIAL ENVIRONMENTAL EXAMINATION (IEE) 4

1.2 PROJECT OVERVIEW 4

1.3 ACTIVITY DESCRIPTION 6

2.0 BASELINE ENVIRONMENTAL INFORMATION

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT,

PHYSICAL, CLIMATE, SOCIAL, THREATENED AND ENDANGERED SPECIES) 9

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL

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

REGULATIONS 9

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

4.0 ENVIRONMENTAL DETERMINATIONS

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS 18

4.2 CLIMATE RISK MANAGEMENT 23

5.0 CONDITIONS AND MITIGATION MEASURES

5.1 CONDITIONS FOR AGENCY IMPLEMENTATION 26

5.2 MITIGATION MEASURES 29

6.0 LIMITATIONS OF THIS INITIAL ENVIRONMENTAL EXAMINATION

7.0 REVISIONS

8.0 REFERENCES

ANNEXES:

ACRONYMS

22 CFR 216 Title 22, Code of Federal Regulations, Part 216 ACT Artemisinin-based Combination Therapy ADS Automated Directives System AM Activity Manager ARV Antiretrovirals BEO Bureau Environmental Officer CAP Corrective Action Plan CO Contracting Officer COR Contracting Officer’s Representative CRM Climate Risk Management EA Environmental Assessment EMMP Environmental Mitigation and Monitoring Plan EMMR Environmental Mitigation and Monitoring Report EPA Environmental Protection Agency ESF Environmental Screening Form FAA Foreign Assistance Act FAO Food and Agriculture Organization FBP Food by Prescription FMP Fumigation Management Plan FP/RH Family Planning and Reproductive Health GH Global Health GHG Greenhouse Gas GS1 Global Standard 1 ICL In-country Logistics IEE Initial Environmental Examination IP Implementing Partner ISO International Organization for Standardization IT Information Technology ITN Insecticide Treated Nets IUD Intrauterine Devices KPI Key Performance Indicators MCHN Maternal and Child Health and Nutrition MEO Mission Environmental Officer MoH Ministry(ies) of Health

NextGen Next Generation Global Health Supply Chain Suite of Programs OECD Organization for Economic Cooperation and Development OHA Office of HIV/AIDS PEA Programmatic Environmental Assessment PERSUAP Pesticide Evaluation Report Safer Use Action Plan PPE Personal Protective Equipment PSA Procurement Service Agent QA Quality Assurance RDT Rapid Diagnostic Tests RoC Record of Compliance RUTF Ready to Use Therapeutic/Supplementary Foods SEA Supplemental Environmental Assessment SOP Standard Operating Procedures SPAQ Sulfadoxine-pyrimethamine + Amodiaquine TA Technical Assistance TB Tuberculosis USAID United States Agency for International Development USG United States Government VMMC Voluntary Medical Male Circumcision WHO-PQ World Health Organization Prequalification Programme WMP Waste Management Plan

1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE OF THE INITIAL ENVIRONMENTAL EXAMINATION (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 United States Agency for International Development (USAID) intervention described herein and recommend determinations and, as appropriate, conditions, for these activities. Upon approval, these determinations become affirmed, and specified conditions become mandatory obligations of implementation. This IEE also documents the results of the Climate Risk Management (CRM) process in accordance with USAID policy (specifically, Automated Directives System [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 objective of the Next Generation Global Health Supply Chain Suite of Programs (NextGen) is to establish and operate high performing and agile supply chains that ensure the procurement and delivery of affordable, high-quality, essential, and life-saving health commodities. NextGen will support the U.S. Government’s (USG’s) global health priorities to prevent child and maternal deaths, control the HIV/AIDS epidemic, eradicate malaria, and combat infectious diseases through the procurement and delivery of health commodities. NextGen is committed to responding to unique requirements of each health program, identifying where to segment functions to maximize performance and respond to different program requirements, and developing a program that attracts reputable commodities providers and increases accountability.

NextGen emphasizes strengthening supply chains in USAID-supported countries through investment in building country commitment and capacity of systems responsible for procurement, storage, distribution, dispensing and related supply chain services to ensure longevity and self-reliance in the absence of foreign assistance.

The NextGen planned awards are:

1. Procurement Service Agent HIV Pharma (NextGen PSA HIV Pharma)

This award will provide procurement and associated supply chain services for HIV/AIDS health commodities excluding HIV/AIDS diagnostic and lab commodities encompassing the required procurement functions of a supply chain (e.g., category management, strategic sourcing, supplier management, demand planning and procurement delivery). The PSA will negotiate incoterms with vendors for delivery of commodities into country, and, in exceptional cases, procure logistics services for commodities purchased under this award to ensure timely delivery. The awardee must coordinate with other awardees under the program.

2. Procurement Service Agent Malaria (NextGen PSA Malaria)

This award will provide procurement and supply chain services for malaria health commodities. It will encompass different services within the procurement as-a-service value chain (e.g., category management, strategic sourcing, supplier management, transactional procurement and demand planning). It will provide a robust information system to support operations and performance improvement. The PSA will negotiate incoterms with vendors for delivery of commodities to country, and as needed, provide freight and warehousing for commodities purchased under this award. The awardee must coordinate with other awardees under the program.

3. Procurement & Logistics Services - Family Planning and Reproductive Health (FP/RH), Maternal and Child Health and Nutrition (MCHN), Other Health Elements (Next Gen PLS)

This award This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for family planning and reproductive health and other health commodities

4. Procurement Service Agent Lab, Diagnostics, and Molecular (NextGen PSA Diagnostics)

This award will provide procurement and associated supply chain services (e.g., category management, strategic sourcing, supplier management, demand planning freight, warehousing, and delivery services) for HIV/AIDS lab, diagnostic and molecular commodities.

5. In-country Logistics (NextGen ICL) One or more awards will provide for in-country logistics and delivery of NextGen commodities.

6. Control Tower for USAID Next Generation Global Health Supply Chain Suite of Programs (NextGen CT)

This award will provide a central hub to provide end-to-end visibility and specific and cross-program information for Missions, Bureaus, Agency leadership and program managers of commodities procured through NextGen.

7. Qualifying Testing Issuing (NextGen QuTI) This award will serve as the primary vehicle to help assure the quality of health commodities purchased under NexGen and other global health programs.

8. Risk Management and Mitigation (NextGen RMM) One or more awards will identify and mitigate supply chain vulnerabilities and potential risks both globally and locally, including fraud, abuse and/or misuse, counterfeit, and diversion of products and financial resources. It will also verify second- and third-tier suppliers and other vendors subcontracted under other NextGen awards to improve supply chain integrity and security.

9. Supply Chain Technical Assistance (NextGen SCTA) One or more awards will provide a comprehensive array of technical assistance (TA) services to improve operational excellence in country supply chains and improve the availability of health commodities to meet the needs of today’s populations and support countries on their journeys to self-reliance to meet the needs of tomorrow’s populations. TA investments could include supporting and strengthening warehousing, distribution, quantification, forecasting, procurement, transportation, and information systems with the mandate to achieve country-led and -managed supply chain systems. The award(s) will provide support to refocus the role of country governments from supply chain operators to stewards of product availability and security. This includes leveraging the broader landscape of country capacities, including increased use of private sector, to improve supply chain performance and client experience.

10. Public Private Partnerships (NextGen PPP) One or more awards will support public private partnerships focused on leveraging private sector expertise to strengthen health systems as it relates to procurement, logistic, supply chain, data sharing, airtime, and strategic marketing expertise, in partnership with central and/or country programs.

1.3 ACTIVITY DESCRIPTION

This IEE (summarized below) covers the In-country Logistics (NextGen ICL) award which will be tasked with the direct management of warehousing, distribution and transportation operations that are deemed necessary by Global Health (GH) because of a lack of host-government logistics capacity. NextGen ICL is implemented through sub-contracted in-country service providers themselves as well as directly through sub-contracted in-country service providers or directly through the awardee itself. NextGen ICL will not be procuring commodities, but takes temporary custody of commodities from other entities for transportation and in rare occasions, may take custody from non-USG entities.

Sub-activities generally fall within a set of illustrative activities for NextGen ICL, including:

Logistic system design. The contractors will establish a structured transportation and warehousing strategy, including storage and transport cost considerations, on-time delivery, and delivery mode options. The contractors will maintain a network of collaborating in-country logistics services providers capable of providing services such as, but not limited to, custom’s clearance, bonded warehousing and in-country transportation services.

Sub-contracting for in-country suppliers. Contractors are to negotiate and award agreements with in-country suppliers of warehousing, distribution and transportation services for the storage and delivery of its funded commodity distributions.

Order fulfillment. Contractors, will provide order fulfillment including picking, packing, and order assembly for transport and warehousing at lower level medical stores and delivery points.

Direct warehousing and transport of commodities. Contractors, as directed by the USAID Contracting Officer’s Representative (COR), will warehouse and transport health commodities, according to agreed upon delivery times, and between designated points of origin to a single and multiple destination within a USAID focus country.

Data management and supply chain oversight. Contractors will establish continuous improvement processes and procedures and provide data on the management of commodities either being stored, transported, or having been delivered.

Recall and waste management assistance. The contractor will assist with the logistics required of any recalls for products that are procured by other USG Agencies, partner countries organizations, implementing partners and/or donors and ensure that appropriate policies and procedures are in place to manage waste and treatment and/or disposal of expired/damaged product.

Customs and importation support. Contractors will support obtention of importation waivers and facilitate the clearance and delivery of USG-procured commodities as necessary. Contractors will provide support, when requested, for customs clearance, warehousing and transport of health commodities neither being procured by the USG or being shipped to a warehouse under the provider.

Procurement, assembly, or construction. Although unlikely, USAID may be asked to provide emergency funding to support procurement and construction of in-country logistics infrastructure. These instances would be the result of natural disasters flooding, typhons, etc., political unrest and other Act of God that causes widespread damage to in-country infrastructure and create a situation that overwhelms a local company’s financial capabilities and or ability to secure commercial financing. In these instances, USAID may decide to provide funding to our partners to construct infrastructure to ensure they can continue to receive, store and deliver critical health care commodities.

The contractors are required to comply with specific contractual standards to ensure best practices and best value for provision of services under NextGen ICL. Additionally, the commodities procured under Procurement Service Agent (PSA) will meet global quality standards, e.g. World Health Organization Prequalification Programme (WHO-PQ) listing, and local regulatory requirements (e.g., registration).

The specified health commodities that NextGen ICL may be handling include those supplied under the USAID PSA awards, but also may include commodities procured or under the control of local Ministries of Health (MoH). NextGen ICL will not be procuring any of these commodities but may take temporary control over the commodities during warehousing or transport or assist with recalls and waste management. The best in class provider would be expected to have appropriate infrastructure in place to be awarded the contract. If they need to make improvements to meet USAID contract requirements, they would be expected to use their own funds or secure commercial financing to bring facilities up to standard for managing commodities.

Commodities handled by the contractors may include but are not limited to the following:

Antiretrovirals (ARVs) Essential medicines Food by prescription (FBP) and ready-to-use therapeutic foods (RUTFs) Male and female condoms and personal lubricants

Voluntary medical male circumcision (VMMC) kits Laboratory supplies Intrauterine devices (IUDs) Insecticide treated nets (ITNs)

Rapid diagnostic tests (RDTs) Malaria treatment drugs (artemisinin-based combination therapy (ACTs), sulfadoxine-pyrimethamine + amodiaquine [SPAQ]) Medicines to prevent and treat tuberculosis (TB) Medicines to prevent and treat opportunistic infections Anti-infective medicines Hormonal contraceptives Medical supplies (gloves, gowns, etc) Medical equipment (hospital beds, etc.)

The NextGen ICL award, in its design, is focused on coordinating and delivering commodities in a reliable, cost efficient, and timely manner. These objectives reduce inefficiencies and ensure local delivery of commodities when and where they are needed. The support for movement of the commodities will help to avoid overstocking, expiration, or change in regimes issues that might commonly result in the need to transport, treat, and/or dispose commodities. Services will adopt or use in-country Global Standard 1 (GS1) to reinforce regulatory compliance and improve traceability and expand commodity visibility (e.g., through use of barcodes).

Will this project/activity involve construction4 as defined by ADS 201 and 303? Yes No

4 4 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.

If yes, describe in the space below:

USAID may be asked to provide emergency funding to support procurement and construction of in-country logistics infrastructure. Construction in this case would include: site work, earthwork, foundations, demolition, fabrication, assembly and renovation and/or refurbishment.

2.0 BASELINE ENVIRONMENTAL INFORMATION

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT, PHYSICAL,

CLIMATE, SOCIAL, THREATENED AND ENDANGERED SPECIES)

The geographic scope of this IEE is global—storage and delivery will be undertaken in any presence or non-presence country. Local conditions, capabilities, and infrastructure will strongly affect the commodities in demand (e.g. antimalarial drugs in malarial areas); viable and appropriate management options for commodities that, for various reasons, must be treated (e.g., incinerated) and/or disposed (e.g., landfilled) of; and which commodities may be safely used and managed by local health facilities. Project activities may occur in both rural and urban environments. NextGen ICL has no control or input into the use of commodities once delivered, and therefore, will never handle healthcare wastes contaminated with blood-borne pathogens, bodily fluids or other infectious waste. NextGen ICL may however assist in the recycling, treatment, and/or disposal or recall of commodities at the request of MoH.

The global nature of the IEE, cannot characterize local conditions, but the activity-EMMPs established by this IEE are the mechanism by which such analysis is made mandatory, and applied to program implementation.

It is hereby verified that, due to the global aspect of this activity, no effect on an endangered or threatened species, or critical habitat, can be determined, in accordance with 22 CFR 216.5. If adverse impacts are found for threatened and endangered species an additional environmental analysis would be required.

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL STANDARDS

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

While this IEE addresses global commodity distribution, the awards implementation will be subject to the environmental, health and safety laws of each host country, and particularly, national requirements regarding management and treatment and/or disposal of commodities, equipment, and pesticides, or WHO “Safe Management of Wastes from Healthcare Activities”.

Where NextGen ICL may be responsible for waste management, NextGen ICL will identify appropriate national standards and manage the waste accordingly. Where national requirements on waste management associated with commodity and equipment disposal do not exist, the selected vendors must comply with International Organization for Standardization (ISO) and WHO standards and best practices (e.g., WHO “Safe Management of Wastes from Healthcare Activities”) noted in their contract in order to receive orders. For pesticides-related waste, international standards from Food and Agriculture Organization (FAO) are available where national requirements do not exist. Provided below is a list of pertinent environmental compliance references. Additional references are provided in Section 8.

A summary of potentially applicable standards, guidelines, and useful references are provided below for developing the Waste Management Plan (WMP) and EMMP. Other references for waste management are identified in Section 4 as specific conditions of the activities.

INTERNATIONAL CONVENTIONS AND AGREEMENTS

Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal Organization for Economic Cooperation and Development (OECD) Council on the Decision on the control of Transboundary Movements of Wastes Stockholm Convention on Persistent Organic Pollutants Minamata Convention on Mercury

USAID RESOURCES AND REFERENCES

USAID. Sector Environmental Guidelines o Solid Waste o Healthcare Waste o Healthcare Facilities

USAID. Integrated Waste Management Plan USAID. Integrated Vector Management Programs for Malaria Vector Control Programmatic Environmental Assessment.

USAID. Green Meeting Checklist (see Annex 2)

OTHER INTERNATIONAL REFERENCES AND STANDARDS

ISO 15190:2020 Medical Laboratories – Requirements for Safety ISO/IEC 17025:2005 General Requirements for the Competence of Testing and Calibration Laboratories ISO 14001 Environmental Management ISO 7765:2004 Safe Management of wastes from health-care activities. (Note: Where national requirements on waste management associated with commodity treatment and /or disposal do not exist, WHO’s “Safe Management of Wastes from Healthcare Activities” handbook is the internationally-recognized standard used by the Bureau for Global Health) WHO List of Prequalified Quality Control Laboratories WHO Good Practices for Pharmaceutical Quality Control Laboratories) WHO Good Practices for Pharmaceutical Microbiology Control Laboratories WHO Good Manufacturing Practices

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

Each of the activities under the NextGen ICL portfolio were evaluated for the potential direct, indirect, and cumulative environmental and social (i.e. health and well-being) risks. The specific locations where the activities take place are yet to be determined; however, activities are generally associated with those taking place at warehouses, in offices, and in transport rather than the natural environment as discussed below.

TABLE 2: ENVIRONMENTAL IMPACTS OF INTERVENTION CATEGORIES AND SUB-ACTIVITIES

Intervention Category 1: Administrative and IT Support, Data Analysis, Assessments, Surveys, and System Design Sub-activity 1.1: Office establishment, country office set-up, award kick-off activities, general office activities

These actions involve research, analyses, capacity building, and data gathering that have no physical impact on the environment with the exception of the potential for managing (recycling, disposing) of computer or IT equipment (e-wastes).

There are no negative social impacts associated with these actions.

Sub-activity 1.2: Establishment of supply chain information technology (IT), data management, and monitoring systems Sub-activity 1.3: Sub-contractor management for transport and warehousing (contract administration, chain of custody management, invoicing, receipt reconciliation) Sub-activity 1.4: Technical assessments (e.g., investigate and address leakage and diversions; spending analysis and cost-effectiveness evaluations) Intervention Category 2: Technical Assistance (TA), Training, and Information Sharing Sub-activity 2.1: Participation in strategy development and planning (i.e., campaigns, resupply, distributions, routing and timing)

These actions involve technical assistance, trainings, meetings, and workshops have no physical impact on the environment except where meetings and event may create office and event related solid waste.

There are no negative social impacts associated with these actions.

Sub-activity 2.2: Information sharing with other NextGen activities and host country authorities (e.g., demonstrating and sharing new logistical approaches) Sub-activity 2.3: Consultations, trainings, meetings, workshops, and coordination with other partners (except on recalls and waste management or pest management in warehouses-See Category 4) Sub-activity 2.4: Participate in planning for phase in and phase out Sub-activity 2.5 Participate in adaptation planning given shocks and emergencies Sub-activity 2.6: Participate in exercises on alternative distribution models Intervention Category 3: Commodities Inventory Management Sub-activity 3.1: Identify and pre-qualify service providers

These actions involve research, analyses, and data gathering that have no physical impact on the environment.

There are no negative social impacts associated with these actions.

Sub-activity 3.2: Establish and monitor inventories and document shelf-life

Intervention Category 4: Quality Control – Management of Expired, Off-specification, Recalled, Damaged, or Mishandled Product Management of expired, off-specification, recalled, damaged, or other mishandled commodities (sub-activity based on USAID’s level of control)

Sub-activity 4.1: In possession of NextGen ICL contractor

The collective NextGen seeks to minimize the potential for expiration, off-specification, recall, and damage to commodities. However, NextGen ICL may specifically be requested to assist other awards or MoH to manage unusable commodities. Additionally, instances may arise where commodities are unusable while in the custody of NextGen ICL. In these cases, the following environmental and social impacts may arise:

a. Improper management of waste commodities may lead to adverse health impacts of workers or the community when wastes are hazardous (e.g., pesticide containing wastes).

b. Disposal of untreated waste via landfilling may lead to leaching of contaminants into the soil and surrounding water sources. 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. In addition, improperly managed or unsecured landfills may allow scavengers to collect disposed health commodities and reuse them or circulate them in the community, which could result in health impacts.

c. Treatment by burning of pharmaceuticals and plastic-containing medical supplies at low temperatures or without adequate air pollution controls can result in release of toxic pollutants into the air and the generation of incineration ash with toxic contents.

d. Improper transportation of commodities may lead to damage to commodities or to spills. Environmental impacts may occur from the use of vehicles to transport wastes (e.g., fuel operation, maintenance, spills, etc.) or traffic accidents.

e. The lack of reverse logistics or direction at the household level on how to handle waste commodities can create a pathway to the environment.