J.10 Initial Environmental Examination (IEE).pdf

INITIAL ENVIRONMENTAL

EXAMINATION

PROJECT/ACTIVITY DATA

Project/Activity: Program: Next Generation Global Health Supply Chain Suite of Programs (NextGen)

Activities:

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

2. Procurement Service Agent Malaria (NextGen PSA Malaria)

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

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-20-10407 Tracking ID of Related RCE/IEE (if any):

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

NEXTGEN PROCUREMENT SERVICE AGENT

SBU-PROCUREMENT SENSITIVE

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

IRS SEAs:

Benin IRS SEA https://ecd.usaid.gov/repository/pdf/51964.pdf

Burkina Faso IRS SEA https://ecd.usaid.gov/repository/pdf/51231.pdf

Dominican Republic IRS SEA https://ecd.usaid.gov/repository/pdf/50149.pdf

Ethiopia IRS SEA https://ecd.usaid.gov/repository/pdf/50927.pdf

Ghana IRS SEA https://ecd.usaid.gov/repository/pdf/45561.pdf

Guatemala IRS SEA https://ecd.usaid.gov/repository/pdf/50423.pdf

Kenya IRS SEA https://ecd.usaid.gov/repository/pdf/49844.pdf

Liberia IRS SEA https://ecd.usaid.gov/repository/pdf/493.pdf

Madagascar IRS SEA https://ecd.usaid.gov/repository/pdf/51033.pdf

Malawi IRS SEA https://ecd.usaid.gov/repository/pdf/51297.pdf

Mali IRS SEA https://ecd.usaid.gov/repository/pdf/48016.pdf

Mozambique IRS SEA https://ecd.usaid.gov/repository/pdf/51596.pdf

Nigeria IRS SEA https://ecd.usaid.gov/repository/pdf/41226.pdf

Rwanda IRS SEA https://ecd.usaid.gov/repository/pdf/50367.pdf

Senegal IRS SEA https://ecd.usaid.gov/repository/pdf/44021.pdf

Tanzania IRS SEA https://ecd.usaid.gov/repository/pdf/45566.pdf

Uganda IRS SEA iii https://ecd.usaid.gov/repository/pdf/52680.pdf

Zambia IRS SEA https://ecd.usaid.gov/repository/pdf/45571.pdf

Zimbabwe IRS SEA 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

Other Affected Operating Unit(s):

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

Total Estimated Cost/Amount Range: 1. Procurement Service Agent HIV Pharma

(NextGen PSA HIV Pharma) Total Estimated Cost/Amount Range: $4 billion

2. Procurement Service Agent Malaria (NextGen PSA Malaria) Total Estimated Cost/Amount Range: $3.1billion

3. Procurement & Logistics Services - Family Planning and Reproductive Health (FP/RH), Maternal and Child Health and Nutrition (MCHN), Other Health Elements (Next Gen PLS) Total Estimated Cost/Amount Range: $750M - $999.99M

If Amended, specify funding amount:

If Amended, specify new funding total:

Prepared by: ECOS Date Prepared: February 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): End of activity/contract.

Additional Analyses/Reporting Required: EMMP, Activity-level CRM; PERSUAP; WMP Climate Risks Identified (#): Low ___0___ Moderate ___9___ High ___3___ Climate Risks Addressed (#): Low ___0___ Moderate ___9___ High ___0___ iv

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

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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 following similar awards for the procurement and shipment of health commodities to key regional distribution centers under specific quality and technical program requirements:

NextGen PSA HIV Pharma NextGen PSA Malaria NextGen PLS FP/RH, MCHN

The other awards/activities have their own IEEs or Requests for Categorical Exclusion.

Within these activities, the IPs will be responsible for managing a diverse and evolving commodity portfolio, strengthening demand planning, and optimizing for agility of the supply chain procurement process and service. Illustrative activities across all of the NextGen PSA awards include:

1. Engaging in portfolio management Phasing out and introducing new products Surveying the marketplace Analyzing spending Planning and strategy development

2. Managing inventory Monitoring inventory levels and shelf-life Initiating and managing replenishment Managing distribution orders to countries Establishing Vendor Managed Inventory (VMI)

3. Sourcing Managing procurement orders across suppliers

Developing sourcing strategies to include international suppliers and in-country wholesalers and distributors Sourcing event management Evaluating proposals Negotiating contracts

4. Managing suppliers Administrating contracts of suppliers

Creating and managing purchase orders Sourcing allocation Invoicing and receipt reconciliation

5. Forecasting demand Analyzing global markets vii

Coordinating demand planning with other global donors

6. Managing data

Collecting, analyzing, and reporting on procurement and logistics Providing technology solutions to support procurement activities including an existing platform, ongoing technology innovation, and platform implementation and management

7. Managing freight

Contracting and managing freight forwarding Clearing customs and directing importation across international boundaries Consolidating and packaging commodities Transportation by ocean, air, and/or ground and consignment Warehousing and storage

Recording and processing shipment documentation Procuring insurance and submission and tracking of insurance claims Tracking and reporting of commodities

8. Building capacity and innovation Proposing new processes and procedures across supply chains such as performance incentives, financing, market dynamic and shaping, cost-of-good analysis, procurement capacity building, decentralized distribution, and delivery of hard to reach facilities Advancing public-private forum events to share data

All suppliers contracted through the NextGen PSA mechanisms must comply with global quality standards, e.g. World Health Organization Prequalification Programme (WHO-PQ) listing, and local regulatory requirements (e.g., registration). Procurement must follow USAID’s commodity eligibility requirements specified in Automated Directives System (ADS) 312 and source and nationality requirements policy as specified in ADS 310. Additionally, upon delivery, the commodities must be registered with the National Drug Regulatory Authorities (NDRA) of destination countries.

The specified health commodities for these four program requirements differ by activity but collectively include:

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 HIV and non-HIV rapid test kits (RTKs) Laboratory supplies Oral contraceptives Injectable contraceptives Implants Intrauterine devices (IUDs) Pregnancy test kits Long lasting insecticide treated nets (LLINs) and insecticide treated nets (ITNs) Personal repellent Indoor Residual Spray (IRS) viii

Rapid diagnostic tests (RDTs) Lab supplies and equipment for diagnosis Malaria treatment drugs (artemisinin-based combination therapy (ACTs), sulfadoxine-pyrimethamine + amodiaquine [SPAQ]) Maternal and child health nutritional for intermittent preventive treatment for pregnant women (IPTp)

NextGen PSA awards, in their designs, are focused on coordinating, purchasing, and delivering the appropriate types and quantities of commodities, to the locations where they are needed, in a timely manner. These objectives to reduce inefficiencies and coordinate purchase and delivery of large procurement of commodities also serve the purpose of mitigating some of, but not all, the environmental impacts and greenhouse gas emissions that are most often associated with these healthcare commodity procurement mechanisms. The attention to ordering and movement of the commodities will help to avoid overstocking, expiration, or change in regimes issues that might commonly result in the need to dispose or transfer commodities. Such instances could lead to environmental contamination, exposure to communities (from waste or from illegal resale), and increased greenhouse gas emissions from additional transportation, incineration, or landfill disposal of the commodities.

NEXTGEN PSA HIV PHARMA

NextGen PSA HIV Pharma will work at the global level with USAID Washington health portfolios and will direct its efforts primarily to the U.S. President's Emergency Plan For AIDS Relief (PEPFAR). PEPFAR is the largest and most diverse HIV/AIDS prevention, care, and treatment initiative in the world and has saved more than 17 million lives through accountable, transparent, and cost-effective investments. As a key implementing partner USAID supports country-led efforts to combat the complex challenges of HIV/AIDS in over 50 countries. USAID’s work prevents and reduces new infections, provides cutting-edge care and treatment, addresses the needs of vulnerable populations, and revitalizes nations to take control of the epidemic – empowering them on their journeys to self-reliance.

The NextGen PSA HIV Pharma award enables access to appropriate use of safe, effective, quality-assured, and affordable medicines related to pharmaceutical services. NextGen PSA HIV Pharma will conduct quantification analysis to determine supply needs and develop a supply plan to meet current demands and minimize the oversupply of health commodities.

Commodities procured for this specific award include ARVs, therapeutic foods, VMMC kits, essential medicines, disinfectants, antiseptics, diagnostic agents, vaccines, laboratory reagents, preventative commodities, water treatment, gloves, sharps, and other general health products.

NEXTGEN PLS - FP/RH, MCHN

The NextGen PLS FP/RH, MCHN 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, maternal and child health and nutrition, and other health commodities.

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NEXTGEN PSA MALARIA

Over the past decade, there has been significant progress in reducing the global malaria burden. However, malaria still impacts millions of people with an estimated 228 million cases and 405,000 malaria deaths in 2018. Reaching the goal of ending malaria in our lifetime, requires continued investment in proven interventions, including the procurement of malaria commodities, and fostering innovation, to address the threats of insecticide resistance and drug resistance. To respond to the continued need for high quality malaria commodities and optimize USAID investments in achieving the availability of quality malaria commodities, procurement services are required to source and supply these commodities.

Procurement services for malarial commodities are targeted at improving the quality of and access to malaria case management and malaria in pregnancy interventions. Within the NextGen PSA Malaria award, this activity will improve the quality of and access to other malaria drug-based approaches. Commodities procured and delivered under this award portfolio include, but is not limited to LLINs, ITNs, personal repellents, malaria treatment drugs, and maternal and child health products. The NextGen PSA Malaria implementer will also coordinate demand planning with other global donors including The Global Fund and host governments.

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 PSA 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

Procurement Service Agent 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

§216.2(c)(2)(viii) Programs involving nutrition, health care or family planning services 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 1.2:

Establishment of supply

§216.2(c)(2)(v) Document and

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

2 GH does not grant Deferrals for projects during the IEE process x chain IT and procurement systems information transfers

Sub-activity 1.3: Spending analysis, marketplace surveys, and market forecasting

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

Sub-activity 1.4: Supplier management (contract administration, sourcing allocation, purchase order creation, invoicing, receipt reconciliation)

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

Sub-activity 1.5: Auditing of suppliers

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

Sub-activity 1.6: Technical assessments

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

Intervention Category 2: Technical Assistance (TA), Training, and Information Sharing Sub-activity 2.1: Strategy development (sourcing and supply planning)

§216.2(c)(2)(viii) Programs involving nutrition, health care or family planning services 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: Support to suppliers to meet specifications and comply with contractual requirements

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

Sub-activity 2.3: Information sharing with other activities, host country authorities

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

Sub-activity 2.4: Market promotion assistance for commodities

§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 2.5: Vetting of services, commodities

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

Sub-activity 2.6: Strengthen governance and strategic planning

§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 2.7:

Consultations, meetings, workshops, and coordination with other partners

§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 2.8: Training of staff on administrative issues, ordering, supply chain management

§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 2.9: Participate, organize, or support public-private forum events

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

Intervention Category 3: Commodities Inventory Management, Sourcing, and Procurement xii

Sub-activity 3.1: Pre-qualify vendors

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

Sub-activity 3.2: Review and selection of products available from manufacturers

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

Sub-activity 3.3: Establish VMI, monitor inventories, and document shelf-life

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

Sub-activity 3.4: Forecasting and supply planning Sub-activity 3.5: Contracting and procurement of commodities Sub-activity 3.6: Sub-contracting for services to assemble kits with specified conditions

Sub-activity 3.7: Training on kit assembly and quality control

§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.)

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 PSA implementer with specified conditions

Sub-activity 4.2: In possession of Mission implementer with specified conditions

Sub-activity 4.3: In possession of assembler/sub-contractor with specified conditions

Sub-activity 4.4: In possession of manufacturer with specified conditions Sub-activity 4.5: In possession of distributor/last mile distributor with specified conditions

Sub-activity 4.6: In possession of MoH Sub-activity 4.7: In possession of other third party (e.g., NGO) (no with specified conditions xiii control) Intervention Category 5: Commodities Shipping, and Freight Management Sub-activity 5.1:

Assessment of distribution networks and warehousing capacity

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

Sub-activity 5.2: Customs support

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

Shipping or freight management of commodities (sub-activity based on USAID’s level of control) Sub-activity 5.3: Through freight forwarder Sub-activity 5.4: Through direct shipping by manufacturer Sub-activity 5.5: Through PSA implementer network with specified conditions Sub-activity 5.6: Through Mission contractor 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

PSA

with specified conditions

Sub-activity 6.2: Through warehouse leased or subcontracted but not managed by PSA with specified conditions

Sub-activity 6.3: Secondary facilities used by a third party (central stores, freight forward staging location, etc).

Intervention Category 7: Pest Control in Warehouses, Ports, Storage Sites, Shipping Facilities Sub-activity 7.1: Contracting 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

CLIMATE RISK MANAGEMENT

This screening is required per the Mandatory Reference for 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 PSA

3 Climate Risk Management for USAID Projects and Activities. https://www.usaid.gov/ads/policy/200/201mal xiv 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 PSA 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 PSA awards. The CRM Summary Table is attached in Annex 1.

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.

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USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATION

PROJECT/ACTIVITY NAME: NextGen: PSA HIV Pharma; FP/RH, MCHN; and Malaria

Bureau Tracking ID: GH-20-10407

Approval: Email approval 11/21/20 Marita Eibl, Acting GH Deputy Assistant Administrator Date

Approval: Email approval 10/30/20 Chuck 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 Katherine Crawford Dennis Durbin Jan Miller Environmental Compliance Database

Jennifer Slotnick Digitally signed by Jennifer Slotnick Date: 2020.11.09 17:02:42 -05'00'

Jennifer Slotnick Digitally signed by Jennifer Slotnick Date: 2020.11.09 17:03:21 -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) 10

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL

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

REGULATIONS 10

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

4.0 ENVIRONMENTAL DETERMINATIONS

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS 17

4.2 CLIMATE RISK MANAGEMENT 24

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 CO Contracting Officer COR Contracting Officer’s Representative CRM Climate Risk Management DFID Department for International Development 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 FIFO First in First out FMP Fumigation Management Plan FP/RH Family Planning and Reproductive Health GH Global Health GHG Greenhouse Gas IEE Initial Environmental Examination IP Implementing Partner IPTp Intermittent Preventive Treatment for Pregnant Women IRS Indoor Residual Spraying ISO International Organization for Standardization IT Information Technology ITN Insecticide Treated Nets IUD Intrauterine Devices LLIN Long Lasting Insecticide Treated Nets MCHN Maternal and Child Health and Nutrition MEO Mission Environmental Officer

MoH Ministry(ies) of Health NDRA National Drug Regulatory Authorities NextGen Next Generation Global Health Supply Chain Suite of Programs NGO Non-governmental Organization OECD Organization for Economic Cooperation and Development PEPFAR U.S. President's Emergency Plan For AIDS Relief PERSUAP Pesticide Evaluation Report Safer Use Action Plan PPE Personal Protective Equipment PSA Procurement Service Agent RDT Rapid Diagnostic Tests RTK Rapid Test Kits RUTF Ready to Use Therapeutic/Supplementary Foods SEA Supplemental Environmental Assessment SOP Standard Operating Procedures SPAQ Sulfadoxine-pyrimethamine + Amodiaquine TA Technical Assistance USAID United States Agency for International Development USG United States Government VMI Vendor Managed Inventory 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 (NextGen 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, maternal and child health and nutrition, 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

OVERVIEW

The activities detailed in this IEE (summarized below) are those that involve several similar awards for the procurement and shipment of health commodities to key regional distribution centers under specific quality and technical program requirements. The implementers will also be responsible for contracting the shipping of commodities to the regional distribution points. The activities are the:

NextGen PSA HIV Pharma NextGen PSA Malaria NextGen PLS FP/RH, MCHN

Within these activities, the agents will be responsible for managing a diverse and evolving commodity portfolio, strengthening demand planning, and optimizing for agility of the supply chain procurement process and service. Illustrative activities across all of the NextGen PSA awards include:

1. Engaging in portfolio management Phasing out and introducing new products Surveying the marketplace Analyzing spending

Planning and strategy development

2. Managing inventory

Monitoring inventory levels and shelf-life Initiating and managing replenishment Managing distribution orders to countries Establishing Vendor Managed Inventory (VMI)

3. Sourcing Managing procurement orders across suppliers Developing sourcing strategies to include international suppliers and in-country wholesalers and distributors Sourcing event management Evaluating proposals Negotiating contracts

4. Managing suppliers Administrating contracts of suppliers Creating and managing purchase orders Sourcing allocation Invoicing and receipt reconciliation

5. Forecasting demand Analyzing global markets

Coordinating demand planning with other global donors

6. Managing data

Collecting, analyzing, and reporting on procurement and logistics Providing technology solutions to support procurement activities including an existing platform, ongoing technology innovation, and platform implementation and management

7. Managing freight Contracting and managing freight forwarding Clearing customs and directing importation across international boundaries Consolidating and packaging commodities Transportation by ocean, air, and/or ground and consignment Warehousing and storage

Recording and processing shipment documentation Procuring insurance and submission and tracking of insurance claims Tracking and reporting of commodities

8. Building capacity and innovation Proposing new processes and procedures across supply chains such as performance incentives, financing, market dynamic and shaping, cost-of-good analysis, procurement capacity building, decentralized distribution, and delivery of hard to reach facilities Advancing public-private forum events to share data

All suppliers contracted through the NextGen PSA mechanisms must comply with global quality standards, e.g. World Health Organization Prequalification Programme (WHO-PQ) listing, and local regulatory requirements (e.g., registration). Procurement must follow USAID’s commodity eligibility requirements specified in ADS 312 and source and nationality requirements policy as specified in ADS 310. Additionally, upon delivery, the commodities must be registered with the National Drug Regulatory Authorities (NDRA) of destination countries.

NextGen PSA awards, in their designs, are focused on coordinating, purchasing, and delivering the appropriate types and quantities of commodities, to the locations where they are needed, in a timely manner. The specified health commodities for these four program requirements differs by activity but collectively include:

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 HIV and non-HIV rapid test kits (RTKs) Laboratory supplies Oral contraceptives Injectable contraceptives Implants Intrauterine devices (IUDs) Pregnancy test kits Long lasting insecticide treated nets (LLINs) and insecticide treated nets (ITNs) Personal repellent Indoor Residual Spray (IRS)

Rapid diagnostic tests (RDTs) Lab supplies and equipment for diagnosis Malaria treatment drugs (artemisinin-based combination therapy (ACTs), sulfadoxine-pyrimethamine + amodiaquine [SPAQ]) Maternal and child health nutritional for intermittent preventive treatment for pregnant women (IPTp)

NEXTGEN PSA HIV PHARMA

NextGen PSA HIV Pharma will work at the global level with USAID Washington health portfolios and will direct its efforts primarily to the U.S. President's Emergency Plan For AIDS Relief (PEPFAR). PEPFAR is the largest and most diverse HIV/AIDS prevention, care, and treatment initiative in the world and has saved more than 17 million lives through accountable, transparent, and cost-effective investments. As a key implementing partner USAID supports country-led efforts to combat the complex challenges of HIV/AIDS in over 50 countries. USAID’s work prevents and reduces new infections, provides cutting-edge care and treatment, addresses the needs of vulnerable populations, and revitalizes nations to take control of the epidemic – empowering them on their journeys to self-reliance.

The NextGen PSA HIV Pharma award enables access to appropriate use of safe, effective, quality-assured, and affordable medicines related to pharmaceutical services. NextGen PSA HIV Pharma will conduct quantification analysis to determine supply needs and develop a supply plan to meet current demands and minimize the oversupply of health commodities. Commodities procured for this specific award include ARVs, therapeutic foods, VMMC kits, essential medicines, disinfectants, antiseptics, diagnostic agents, vaccines, laboratory reagents, preventative commodities, water treatment, gloves, sharps, and other general health products.

NEXTGEN PLS FP/RH, MCHN

The NextGen PLS FP/RH, MCHN 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, maternal and child health and nutrition, and other health commodities.

NEXTGEN PSA MALARIA

Over the past decade, there has been significant progress in reducing the global malaria burden.

However, malaria still impacts millions of people with an estimated 228 million cases and 405,000 malaria deaths in 2018. Reaching the goal of ending malaria in our lifetime, requires continued investment in proven interventions, including the procurement of malaria commodities, and fostering innovation, to address the threats of insecticide resistance and drug resistance. To respond to the continued need for high quality malaria commodities and optimize USAID investments in achieving the availability of quality malaria commodities, procurement services are required to source and supply these commodities.

Procurement services for malarial commodities are targeted at improving the quality of and access to malaria case management and malaria in pregnancy interventions. Within the NextGen PSA Malaria award, this activity will improve the quality of and access to other malaria drug-based approaches. Commodities procured and delivered under this award portfolio include, but is not limited to LLINs, ITNs, personal repellents, malaria treatment drugs, and maternal and child health products. The NextGen PSA Malaria implementer will also coordinate demand planning with other global donors including The Global Fund and host governments.

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

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:

The awards will not construct any warehousing or distribution facilities but may operate or contract warehousing services.

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—commodity procurement 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 disposal options for commodities that, for various reasons, must be treated (incinerated) and/or disposed (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. PSA 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.

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.

All commodities procured by NextGen PSA are subject to standards specified by the award (most often WHO pre-qualified) and on essential medicine lists. The contractor must consider all relevant U.S. cargo preference laws as well as USAID’s cargo preference policy found in ADS 315 and USAID’s policy governing other aspects of delivery services found in ADS 314.

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 disposal of commodities, equipment, and pesticides, or WHO “Safe Management of Wastes from Healthcare Activities”.

Where PSA may be responsible for waste management, PSA 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 (i.e., procured through NextGen PSA Malaria), 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…