s[+lci - ecd.usaid.gov · initial environmental examination global health supply chain program -technical assistance (ghsc-ta) amendment no. 1 1. executive summary 1.1

1.5 APPROVAL OF ENVIRONMENTAL DETERMINATION AND MEASURES

1.5.1 Clearance: ------ --------· -----=-=--=------

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Date Doug Arbuckle,

Office Director, GH, OHA

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Date Elizabeth Fox, Office Director (Acting), GH, ID '

~~~ s[+lci Date

Ellen Starbird, Office Director, GH, PRH

r 7 Date

Sharmila Raj, COR, GH/PRH/CSL

1.5.2 Concurre nce:

Rachel Dagovitz Date Global Health Bureau Environmental Officer -

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Health Supply Chain Program

(formerly Global Health Commodity Program) for the USAI D Global Healt h Supply Chain- Technical Assistance (GHSC-TA}

Contract 7

1.5.3 Distribution List:

Brian Hirsh, BEO, Africa Bureau Diana Shannon, LAC Bureau Will Gibson, BEO Asia Bureau

Mark Kamiya, BEO, E&E Bureau


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA}

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INITIAL ENVIRONMENTAL EXAMINATION

GLOBAL HEALTH SUPPLY CHAIN PROGRAM -TECHNICAL ASSISTANCE (GHSC-TA)

Amendment No. 1

1. EXECUTIVE SUMMARY

1.1. PROGRAM/ACTIVITY DATA

Program/Activity Number 936-3090 Program/ Activity Title Global Health Supply Chain (GHSC) Program Project USAID Global Health Supply Chain-Technical Assistance

(GHSC-TA) Contract (multiple award indefinite delivery, indefinite quantity contract)

Country/Region Global

USG Foreign Assistance Framework Functional Objective Number & Name Investing in People Program Areas: Hea lth Program Elements, as appropriate, HIV/AIDS, malaria, other public health threats, family planning and reproductive health

Period Covered 8 years -FY 2012- 2020 Life of Project Amount $500 million

IEE Amendment Yes. Amendment No. 1 consists of separate documents prepared to replace each award previously covered by the Global Health Commodit~ Program 2013-2018 PIEE. This IEE covers the GHSC-TA award.

If yes, date of original IEE: Approved on December 17, 2012 Management Unit Contact Point Sharmila Raj, COR, [email protected]

Technical Offices GH/OHA, GH/ID, GH/PRH, GH/MCHN

1.2. ENVIRONMENTAL ACTION RECOMMENDED

Categorical Exclusion x Negative Determination x Positive Determination x EMMP x

Project does not cover the 1. No construction other than construction connected with modular following activities warehouses and other units and nonstructural or cosmetic work for in

country structures. 2. Procurement of goods and services is not permitted except as they relate to technical assistance under this award.

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAM INATION or the Global Health Supply Chain Program

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1.3 THRESHOLD ENVIRONMENTAL DETERMINATIONS

Activity or Activity Category

1. Systems strengthening technical assistance including strategic planning, design assistance for country supply systems and data management

2. Capacity building including training and improvement of technology systems

3. Procurement, transport, storage and disposal of health commodities, general medical supplies and equipment, including disposal of nonhazardous or general waste and hazardous materials

Note: Procurement of goods and services is not permitted except as they relate to technical assistance under this award.

4. Construction and rehabilitat ion of infrastructure and facilities

Note: No construction is permitted except construction connected with modular warehouses and other units and nonstructural or cosmetic work for in-country structures.

5. Procurement, storage, distribution, use and management of pesticides

Recommended Determinatian · ... ,., . •·- .,.

Categorical exclusion, per 22 CFR 216.2{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)

Categorical exclusion, per 22 CFR 216.2{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 or generation of healthcare waste etc.)

Negative Determination with conditions, per 22 CFR 216.3(a)(2)(iii)

1. Small scale activities in this category, defined as those involving a total disturbed area equal to or less than 1,000m2

Negative determination with conditions, per CFR 216.3(a)(2)(iii)

2. Medium to large scale activities in this category, defined as those involving a total disturbed area greater than 1,000m2 on a given site

Positive Determination, per 22 CFR 216.3(a)(2)(iii), with resulting scoping study and, as necessary, EA developed and approved by the IDIQ COR and GH BEO

Negative Determination with conditions, per 22 CFR 216.3(a)(2)(iii)


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain-Technical Assistance (GHSC-TA-)

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6. Procurement, installation, For incinerators with capacities~ 200 lbs/hour and ~ 2000 commissioning, management, and lbs/week1 and in-ground disposa l faci l it ies ~ 100m3 capacity maintenance of hazardous waste

Negative Determination with conditions, per 22 CFR treatment equipment and installations

216.3(a)(2)(iii)

Note that construction associated with haza rdous waste treatment equipment installat ion is also subject to the For incinerators> 200 lbs/hour or 2000 lbs/week and in-

requirements of category 4. ground disposal facilities> 100m3 capacity

Positive Determination, per 22 CFR 216.3(a)(2)(iii), with resulting scoping study and, if necessary, an EA developed and approved by IDIQ COR and the GH BEO

For hazardous waste treatment equipment and installations other t han incinerators and in-ground facilities

Negative Determination, per 22 CFR 216.3(a)(2)(iii) with conditions

1.4 SUMMARY OF IMPLEMENTATION, MONITORING, AND REPORTING MEASURES

The following standard conditions in section 1.4 consist of conditions for project implementation for all Global Health mechanisms as well as addit ional conditions developed specifically for this project.

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

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

3. COR monitoring responsibilities. As requi red by the ADS 204, the COR will act ively monitor and eva luate whether the conditions of this IEE are being implemented effect ively and whether new or unforeseen consequences arise during implementation not identified and reviewed in this IEE. If new or unforeseen consequences arise, the team will suspend the activity and init iate appropriate, further review, in accordance with 22 CFR 216.

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

1 Size definition for incinerators is based on US Clean Air Act Section 129(a)(2) implementing regulations ("Hospital Medical Infectious Waste Incineration (HMIWI) Regulation"), and conservatively combines the "very small" weekly limit and the "small" pounds/hr limit. See e.g. http://www.combustionportal.org/hmiwi.html Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Globa l Health Supply Chain Program

(formerly Global Hea lth Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA 1 Contract 3 ·

5. Integration of compliance responsibilities in prime and subcontracts, agreements, and grants. The COR sha ll ensure that contract documents reference and require compliance with the conditions set out in this IEE, as required by ADS 2014.3.4{a)(6) and ADS 303.3.6{3)(e). The Implementing Partner shall assure that subcontracts, agreements, and grants reference and require compliance with relevant elements of these conditions.

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

The Implementing Partner is responsible for annually preparing and submitting to the COR an Environmental Mitigation and Monitoring Report {EMMR) to document compliance with the conditions of this IEE. The EMMR must be submitted to the COR within 60 days after the end of each fiscal year. The EMMR template is attached to the IEE.

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

a. If activities outside the scope of this IEE are planned, the COR shall assure that an amendment to this IEE addressing these activities is prepared and approved prior to implementation of any such activities.

b. Any ongoing activit ies found to be outside the scope of this IEE shall be modified to comply or halted until an amendment to this IEE is submitted and approved.

8. Pesticides or pesticide products. Any program activities conducted under this Agreement involving the procurement, use, research or disposal of pesticides and/or larvicides, {other than WHO-approved LLINS) and their waste products will require a supplemental IEE, SEA, or PERSUAP based on consultations with the Bureau Environmental Officer for Global Health. Small scale and routine use of contact pesticide/rodenticide is excepted, although their management and disposal is to be addressed in the SOPs for core activities.

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

10. Compliance with human subject research requirements. The COR in consultation with the BEO for the Global Health Bureau shall assure that the Implementing Partner and sub-awardees


(former ly Global Health Commodity Program) for the USAID Global Health Supply Chain-Technical Assistance (GHSC-TA ~

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demonstrate completion of all requirements for ethics review and adequate medical monitoring of human subjects who participate in research trials carried out through this agreement. The BEO for Global Health may request copies of documentation from the COR to demonstrate compliance with applicable requirements of human subject trials. All documentation demonstrating completion of required review and approva l of human subject trials must be in place prior to initiating any trials and cover the period of performance of t he trial as described in the research protoco l.

11. Development and implementation of SOPs. The Implementing Partner will be responsible for preparing Sta ndard Operating Procedures (SOPs) for co re responsibilities that have potential to resu lt in environmenta l impacts which include but are to limited to operation of warehouse facilities, transportation of healthcare commodities, inventory management, general and hazardous waste management and disposal, other operational activities as identified. These SOPs must be approved by the COR and reflect properly-referenced industry best practices.

12. Solicitation of international transport and disposal of hazardous waste. The solicitation of third party services for the internationa l transport and disposal of hazardous and potentially hazardous waste, including unusable pharmaceut icals and other hea lt h commodities, requires prior review and approval of solicitation documents by the COR and concurrence by the GH BEO.

13. Interim Environmental Compliance Review. Within the first four years after the kick-off meeting/beginning work, the COR and GH BEO will set a date for the project to undergo an environmental compliance review (ECR) to determine compliance with 22 CFR 216 requirements and t he conditions of th is IEE. The scope of the ECR will be developed by the GH BEO and submitted to the COR for review and concurrence. The GH Technical Offices wil l fund the ECR and provide access to project records as needed to conduct the review.

14. Closeout of activity, environmental responsibilities. The Implementing Partner will prepare a closeout plan consistent with contract documentation fo r COR review and approva l that outl ines responsibilities for end-of-project operation clean-up and disposal of healthcare, and other wastes, and/or transition of other operational responsibilities. Where identified as needed, the closeout/transition operation wi ll provide tra ining to support continuity of environmental responsibil ities.

15. Waste Management Plan. If an Implementing Partner will be managing an activity that generates waste streams, the Implementing Partner wi ll prepare or use an existing integrated Waste Management Plan {WMP) that will define and detail direct and indirect waste streams generated by IP-managed activities and specify appropriate management and disposa l practices for each. The primary components required in a WMP are described in Annex B.

16. Mercury-containing commodities. The IP will not procure mercury-containing commodities. Any exception to the rest riction must be submitted in writing with the justification to the COR for approval.

17. Asbestos and lead-based paint. The IP will not use construction materials conta ining asbestos or lead-based paint. When conducting renovation on existing buildings, the IP w ill investigate for the presence of asbestos or lead paint prior to initiating work and will provide appropriate PPE and a

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or t he Global Health Supply Chain Program

(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA 1 Contract 5

disposal process for handing the hazardous waste, if identified.

18. Air pollution control technology for incinerators. IP procurement or operation of large sca le incinerators, see Sections 1.3 and 2.6.1 of this IEE for size thresholds, must contain adequate air pollution control technology to ensure compliance with host country guidelines and applicab le international air quality emission requirements, including:

• 74 FR 51367: US Environmenta l Protection Agency. Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Hospital/Medical/Infectious Waste Incinerators; Final Rule. October 6, 2009.

• Directive 2000/76/EC: Of the European Parliament and of the Council of 4 December 2000 on the incineration of waste.

• AP 42 and Emission Factors: US Environmental Protection Agency.


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain-Technical Assistance (GHSC-TA}

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SECTION 2: IEE SUPPORTING INFORMATION

2.1. PROGRAM/ACTIVITY DATA

Program/Activity Number 936-3090

Program/ Activity Title Global Health Supply Chain Program

Project USAID Globa l Hea lth Supply Chain-Technica l Assistance {G HSC-TA) Contract (multiple award indefinit e de livery, indefin it e quantity contract)

Country/Region Globa l

USG Foreign Assistance Framework Functiona l Objective Number & Name Investing in Peop le Program Areas: Health Program Elements, as appropriate, HIV/AIDS, malaria, other public hea lth t hreats, family planning and reproductive health

Period Covered 8 years: FY 2012 - 2020

Life of Project Amount $500 mill ion

IEE Amendment Yes. Amendment No. 1 consist s of separate documents prepared to replace each award previously covered by the Globa l Hea lth Commodity: Program 2013-2018 PIEE. This IEE covers the GHSC-TA award .

M anagement Unit Contact Point Sharmila Raj, COR, Sraj@usaid .gov

Technica l Offices GH/OHA, GH/ ID, GH/ PRH, GH/MCHN

2.2. PURPOSE AND SCOPE

Purpose. The purpose of t his document-in accordance w ith Title 22, Code of Federal Regulations, Part 216 {22 CFR 216)-is to replace the Global Health Commodity Program 2013-2018 PIEE and establish each award with its respective environmental document. For GHSC-TA activit ies; this IEE replaces and supersedes the GHSC program-wide PI EE approved in 2012 and available at http://gemini .info.usaid.gov/egat/envcomp/repository:/pdf/38983.pdf

The five awards under t he Global Health Supply Chain {GHSC) Program include:

GHSC-Procurement and Supply Management {GHSC-TA): Procurement and shipping of hea lt h commodities; supply chain technical assistance GHSC-Rapid Test Kits (GHSC-RTK): Procurement and shipping of HIV RTKs GHSC-Technica l Assist ance {GHSC-TA): Supp ly chain technica l assistance GHSC-Quality Assurance (GHSC-QA): Quality assurance of procured commodities; technica l assistance GHSC-Business Intelligence and Analyt ics {GHSC-BIA): Collect and integrate data across programs to support GHSC management and coordination

This IEE corresponds to the GHSC-TA act ivit ies and provides a preliminary review of the reasonably foreseeable effects on t he environment of all activit ies under USAID's new programming framework for the GHSC-TA project. The IEE also provides recommended t hreshold determinations and, as appropriat e, at tendant condit ions, fo r t hese act ivities. Upon final approval of this IEE, these Amendment No.1 t o the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAM INATION or the Global Hea lth Supply Chain Program


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recommended determinations are affirmed as 22 CFR 216 Threshold Decisions, and conditions become mandatory elements of GHSC-TA implementation.

In addition, this IEE sets out project2-level implementation procedures intended to assure that conditions in this IEE are translated into activity-specific mitigation measures, and to assure systematic compliance with this IEE during project and program implementation. These procedures are themselves a general condition of approval for the IEE, and their implementation is therefore mandatory.

The funding ceiling is $150 million in Core funds over five years for the entire GHSC-TA Program. The project will be implemented from 2017 to 2022.

2.3. PROGRAM OVERVIEW

2.3.1. Background

Successful implementation of USAID's health sector programs depends considerably on the consistent

supply of quality health commodities, as well as supply chain assistance to health systems that manage

these commodit ies. An uninterrupted supply of health products to health facilities and patients

worldwide is extremely challenging to achieve for various reasons, such as the difficulty of excluding

ineffective and substandard medications into the supply chain. Further, highly specialized procurement

and logistics expertise is required to oversee and manage the delivery, storage, distribution, and

disposal of health commodities.

For these reasons, GH's portfolio includes programs intended to provide an uninterrupted supply of

quality-assured health products to health facilities and patients worldwide. These products include,

among others, a wide variety of pharmaceuticals, vaccines, nutritional supplements, contraceptives

products, consumable medical supplies, test kits, laboratory supplies, and medical and laboratory

equipment.

Formerly, GH had two flagship contract mechanisms responsible for the procurement and delivery of

essential hea lth commodities: the Supply Chain Management System (SCMS)3 and the DELIVER Project.4

SCMS focused on health commodities addressing HIV/AIDS under the President's Emergency Plan for

AIDS Relief (PEPFAR). The DELIVER Project focused on the Presidential Malaria Initiative (PMI) and

programs in family planning/reproductive health, maternal and child health, emerging pandemic

2 The terms "activity" and "project" are used throughout this IEE per their standa rd meaning in environmental impact

assessment and as commonly used by Implementing Partners, and NOT as per USAID's programming framework. As such, a

project is a cluster of activities executed under a single, thematically focused prime contract or award (e.g. GHSC-QA). By contrast, in USAID's programming framework, "project" describes a sector- or sub-sector portfolio, covering multiple

contracts or awards, and "activity" denotes a single such contract or award ("implementation veh icle").

3 http://www.usaid.gov/news-information/fact-sheets/supply-chain-management-system; http://scms.pfscm.org/scms.

4 http://deliver.jsi.com/dhome


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA ~

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threats, and other areas. These mechanisms provided systems technical assistance for strengthening

supp ly chains and commodity security systems in conjunction with System for Improved Access to

Pharmaceuticals (SIAPS) and Promoting the Quality of Medicines (PQM).

Ensuring reliable supplies of healthcare commodities is critical to meeting the health care needs of host

country popu lations and to the success of USAID's own health programs. GHSC-TA will procure and

manage a wide range of health commodities, supp lies, and equipment essential for management of

malaria, HIV/AIDS, family planning, and maternal and child health. An inherent part ofthis support wil l

require treatment and disposal of nonhazardous and hazardous materials, including unusable medica l

products and commodities.

The GHSC-TA award will be an additional source of technical assistance for missions and host countries

and related goods and services. It will provide the fu ll range of supply chain technical assistance

encompassing the different elements of a comprehensive supply chain (e.g. quantification/forecasting,

procurement, t ransportation, warehousing, and information systems). It enhances competition by

increasing t he number of implementing partners, and gives countries more choices in supply chain

assistance. The TA contract is a five-year multi-award contract with a total contract value of $500

million.

The purpose of the GHSC-TA award is to provide expert technical assistance:

• To strengthen country health supply systems,

• To strengthen regional organizations and south-south learning for improved long-term

commodity availability across all health elements (e.g. family planning, maternal and child

hea lth, TB, HIV/AIDS, malaria, and other infectious diseases) .

2.3.2. GHSC-TA Management Approach

There wil l be both centrally-managed and mission task orders under the GHSC-TA award. This section describes the management approach, including ro les and responsibilities, for environmental compliance activit ies required under t his award.

GH COR Responsibilities for Core Activities

The GH COR and Technica l Offices are located at USAID locations in Washington, D.C. They have primari ly centrally-managed activities that are Mission-funded. However, there may be some instances where field activities are centrally-managed. As required by ADS 204, the GH COR actively monitors and eva luates whether the conditions of this IEE are implemented effectively and whether new or unforeseen environmental impacts from Core or Mission Activities arise during implementation not identified and reviewed in this IEE. The GH COR will advise Missions when additional environmental ana lysis/documentation is needed. The Missions will be responsible for its preparation. For centrally-managed fie ld activities, t he GH Technical Office will be responsible.

If new or unforeseen environmental impacts arise, the designated GH COR will investigate the activity and take appropriate action, including suspending the activity until the appropriate review in


(formerly Globa l Health Commodity Program) for the USAID Global Health Supply Chain- Technica l Assistance (GHSC-TA ~

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accordance with 22 CFR 216 is completed. If a Core Activity outside the scope of th is IEE is planned, the COR will assure that an amendment to this IEE addressing the activity is prepared by the designated GH COR and GH Technical Office and approved by the GH BEO prior to implementation of any such activity. Any ongoing activities found to be outside the scope of this IEE shall be modified to comply or halted until an amendment to this IEE is approved.

The COR is responsible for reviewing and clearing EMMPs that are prepared for the GHSC-TA award and activity-level EM MPs that are submitted with Mission-buy-in. EMMPs are provided to the COR for clearance and then forwarded to the GH BEO for approval. Technical Offices will monitor Mission environmental compliance and assist Missions in preparing IEEs, IEE amendments, EM MPs and other environmental compliance documents. The GH COR is responsible for consulting with the GH BEO to review the activity and determine if additional environmental analyses are needed. Certain activities are already identified in this IEE as requiring additional environmental analyses.

Mission Responsibilities for Mission Activities Mission activities are mission-funded and managed activities. Missions, not GH Technical Offices or GH CORs, are responsible for preparing country-specific IEEs, IEE amendments, activity-level EMMPs, and other environmental documents for Mission Activities. The GH Technical Office or COR will assist Missions in preparing these environmental documents. Since this IEE covers both Core and Mission activities under the GHSC-TA award, a Mission may use the GHSC-TA EMMP as guidance to obtain representative mitigations for corresponding a Mission activity, but are responsible for preparing the activity-level EMMP, which identifies the responsible persons for implementing activities and mitigation plans. Missions will provide the GH COR with activity level EM MPS for Mission activities to assist the GH CORs with their monitoring responsibilities

Some activities will require additional environmental analysis (e.g., Scoping Statement , Environmental Assessment). These additional analyses will be undertaken by the Mission team and submitted to the GH COR for review and clearance as outlined in this IEE. Some environmental analyses also require GH BEO approval as specified in this IEE.

Missions are primarily responsible for oversight of environmental requirements corresponding to the Missions and will actively monitor and evaluate whether the conditions of Mission IEEs and EM MPs are implemented effectively and whether new or unforeseen environmental impacts arise during implementation not identified and reviewed in the Mission IEEs. The GH COR and Technical Offices will be responsible for monitoring Mission environmental compliance.

If new or unforeseen environmental impacts arise from a Mission Activity, the Mission will notify the appropriate GH COR and investigate the activity and take appropriate action, including suspending the activity until the appropriate review in accordance with 22 CFR 216 is completed.

The Mission shall assure that the appropriate IEE documentation is in place prior to implementation of any such activity. The Mission shall not undertake activities that are not addressed in the GHSC-TA IEE.

2.3.3. Description of GHSC-TA Activities

USAID's technical assistance for supply chain management and commodity security has been critica l



in achieving positive health outcomes worldwide. Techn ical assistance to strengthen the performance of supply chains has contributed to reduced stock-out rates of key health commodities. Sustained efforts to improve environments for commodity security in such areas as coordination, policy, and financing have helped ga lvan ize and sustain broader host country commitment to provid ing health commodities in the long-term. Activities include a combination of strategic planning, design and capacity building with ci rcumstances where the project will be substantive ly involved in act ual implementation of supply logistics w here country systems benefit f rom addit ional strengthening through third party implementat ion support.

The Implementing Partner will undertake activities to improve performance, as well as to support greater country ownership in ensuring commodity security. The project will support the commodity availability required in the near- to medium-term to support country health plans and global initiatives such as Family Planning 2020, PEPFAR, PMI, and A Promise Renewed, but also help position supply systems to face the challenges and seize the opportunities of longer-term trends, such as economic transitions, demographic shifts, evolving disease burdens, and public health priorities.

Technical assistance under this IDIQ may be short or long-t erm and is designed to be tailored to an individual country's needs - w hether the country is considered post-conflict, transitional or developing. Within each country, the technical assistance activities will be coordinated with other USG and non-USG activities associated w ith other systems strengthening programs. The Project will focus on using, wherever feasible, in-country supply cha in systems and organizations, whether public, private, or non-profit, rather than establishing and operating its own supply chain.

There will likely be circumstances where the Implementing Partner(s) may be ca lled upon to directly manage a country supply chain in order to ensure that commodities reach their intended clients. The Implementing partner(s) will be required to directly provide warehouse and inventory management of health commodities. The Implementing Partner will be directly involved in health commod ity logistics including the distribution and t ransportation of commodities within the country. Specific activities under this award include:

Objective 1: Systems Strengthening Technica l Assistance - Strengthening in-country supply systems.

Strategic Planning - Provide strategic planning and design assistance In-country logistics - Improve delivery of health commodities to service sites Capacity-building - Effective transfer of skills, knowledge and technology for improved and sustained performance. Enabling environments - Strengthen enabling environments to improve supply chain performance.

Objective 2: Global Collaboration - St rategic engagement to improve the long-term availability of health commodities.

Global Strategic Engagement with partners for planning and implementation. Support global partners to utilize lessons learned and share best practices. Advocacy- Cont inued awareness-raising and advocacy to improve availability of health commodities. Coord ination - Effective coord ination with all USAID-funded supply cha in activities and within

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMI NATION or the Globa l Health Supply Chain Program

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the international development community

2.4. BASELINE INFORMATION AND APPLICABLE HOST COUNTRY REQUIREMENTS

2.4.1. Locations Affected

The geographic scope of this IEE is global and GHSC-TA activities will potentially be undertaken in any presence or non-presence country. Technica l assistance under this activity is tailored to an individual country's needs - whether the country is considered post-conflict, transitional or developing. The nature of technical assistance provided under this award will vary according to the needs of a country. For example, a country in transition may require the contractor to distribute commodities directly to service delivery points, whereas a country in a more advanced state of development may need assistance in optimizing a transport network that the country can run themselves. The majority of the project will be for work implemented in field programs and will be done by hiring loca l partners with host country expertise. Work may be conducted in either rural or urban environments.

2.4.2. Applicable Laws, Regulations and Policies

While this IEE addresses technical assistance at the global level, its 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.

In add ition to any host country requirements, international requirements - such as those of the Basel Convention on the Transboundary Movements of Hazardous Wastes and Their Disposal- might be relevant for post-use or expired commodities classified as hazardous wastes. 5

Where national requirements on waste management associated with commodity disposal do not exist, WHO's "Safe Management of Wastes from Healthcare Activities" handbook is the internationally-recognized backstop standard.6 For pesticides-related waste, international standards from Food and Agriculture Organizat ion (FAO) are ava ilable where national requirements do not exist. Provided below is a list of pertinent environmental compliance references. Additiona l references are provided in Annex C.

Primary Environmental Compliance References:

• WHO. Safe Management of Wastes from Health-Care Activities (2014)

• WHO. Guidelines for Safe Disposa l of Unwanted Pharmaceuticals in and after Emergencies

(1999)

• WHO. Preparation of National Health-Care Waste Management Plans in Sub-Saharan

Countries (2005)

• Applicable host countries environmental laws and regulations • Basel Export-Import Control Tool • Basel Convention - Guidance Manuals • USAID. In tegrated Vector Management Programs for Malaria Vector Control: Programmatic

5 http://www.basel.int/Porta ls/4/Basel%20Convention/docs/text/BaselConventionText-e.pdf 6 http://www.who.int/water sanitation healt h/publications/wastemanag/en/ Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Health Supply Chain Program

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Environmental Assessment (2012 Update). Volume 1of2 (Main Document)

• USAID. Integrated Vector Management Programs for Malaria Vector Control: Programmatic Environmental Assessment (2012 Update). Volume 2 of 2 (Annexes)

• USAI D. Integrated Vector Management Programs for Malaria Vector Control: Programmatic Environmental Assessment (2017 Update).

• FAO. International Code of Conduct on the Distribution and Use of Pesticides: Guidelines on

Management Options for Emptv Pesticide Containers. (May 2008)

• FAQ. Pesticide Storage and Stock Control Manual (1996)

Supplemental Environmental Compliance References:

• USAID Sector Environmental Guidelines • John Snow, lnc./USAID DELIVER Project in collaboration with WHO. Guidelines for the Storage

of Essential Medicines and Other Health Commodities (2003) • USAID DELIVER Project. Guidelines for Warehousing Health Commodities (Second Edition

2014). Task Order 4. • USAID DELIVER Project. Guideline for Managing the Malaria Supply Chain: A Companion to

the Logistics Handbook (2011) • USAID DELIVER Project. The Logistics Handbook: A Practical Guide for the Supplv Chain

Management of Health Commodities (2011) • USAID DELIVER Project. Transport Management: A Self-Learning Guide for Local Transport

Managers of Public Health Services (October 2010) • WHO. Recommendations on the sound management of packaging for long lasting insecticidal

nets (2011)7

• WHO. Recommendations on the sound management of old long-lasting insecticidal treated nets (2011)8

• Global Health Commodity Program PIEE 2013-2018 http://gemini.info.usaid.gov/egat/envcomp/ repositorv/pdf/38983.pdf

2.5. EVALUATION OF POTENTIAL ENVIRONMENTAL IMPACTS

This section examines the potential adverse environmental and health impacts of GHSC-TA by category

Activity Category Environmental Impacts

1. Systems strengthening Activities related to technical assistance including studies, planning, technica l assistance including information transfer and other related activities are not anticipated strategic planning, design to have environmental impacts. However, should technical assistance for country supply assistance involve actual field implementation, then the re could be systems and data environmental impacts depending on the activities. management 2. Capacity building including Education, technical assistance, or training programs do not typically training and improvement of have environmental impacts except to the extent when the training technology systems or capacity building incorporates actual field demonstration of the

process, which may have environmental impacts.

7 http://www.who.int/malaria/publications/atoz/recommendations_management_llin_packaging_novll.pdf 8 http://www.who.int/malaria/publications/atoz/who-recommendation-managing-old-llins-mar2014.pdf Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Health Supply Chain Program

(formerly Global Health Commodity Program) for the USAID Global Health Supply Chai n-Technical Assistance (GHSC-TA ~

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3. Procurement, transport, storage and disposa l of health commodities, general medical supplies and equipment, including disposal of nonhazardous or general waste and hazardous materials

Management includes procurement, direct importation across international boundaries, transportation & warehousing, and consignment. Drugs and general medical supplies and commodities may include (but are not limited to) :

• Pharmaceutical drugs • Immunization supplies

• Nutritional supplements • Laboratory supplies and reagents

• Family planning products and condoms • Male circumcision kits • Cleaners, disinfectants, and sterilants • PPE for health workers

• Long-lasting insecticide t reated nets

Equipment includes:

• Clinical and laboratory equipment • Office equipment and supp lies

Although GHSC-TA is focused on strategic planning and strengthening of in-country supply logist ics, there could be instances where the Implementing Partner assumes portions of the supply logistics, including waste disposal. The discussion below covers environmental impacts that could result from waste disposal.

Activities include disposal of nonhazardous and hazardous wastes, including exportation of hazardous waste across international boundaries. The Implementing Part ner wi ll generally not manage waste produced by consignees, as the Implementing Partner no longer owns the commodities once they are consigned and has no contro l over their use or disposal. However, it will manage nonhazardous/general waste and hazardous materia ls under the following circumstances:

• Waste resu lting from its own disposals of stock (e.g. expi red or damaged goods)

• Waste resulting from QA/QC operations • Waste resulting from take-back of unused commodities from

consignees

• Specific commissions t o manage or remediate waste

Nonhazardous or general waste includes waste that does not pose any particu lar biologica l, chemical, radioactive or physica l hazard)

Hazardous material includes (WHO definition) :

• Infectious waste • Pathological waste

• Sharps

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or t he Global Health Supply Chain Program


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4. Construction and rehabi litation of infrastructure and facilities

·GHSC-TA may be required to conduct smal l-sta le construction or renovation of facil ities to provide storage facilities for health commodities. Construction may also include installation of modular warehouses and other units.

Construction and rehabilitation has a potential adverse impacts described be low:

• Disturbance to existing landscape/habitat. Clearing, grading, trenching and other activities can result in disturbance to the pre-existing landscape/habitat within the plot. If the plot contains or is adjacent to a permanent or seasonal stream/waterbody, grading and leveling can disrupt local drainage.

• Sedimentation/fouling of surface waters. Runoff from cleared ground or materials stockpiles during construction can resu lt in sedimentation/fouling of surface waters, particularly if the site is located in close proximity to a stream or waterbody.

• Standing water. Activities may result in standing water onsite, wh ich readily becomes breeding habitat for mosquitoes and other disease vectors.

• Impacts of materials sourcing. Construction activities require a set of materials often procured locally: timber, fi l l, sand and gravel, bricks. Unmanaged extraction of these materials can have adverse effects on the environment.

• The use of toxic materials such as asbestos, lead paint, formaldehyde (sometimes used in products like particle board, plywood, and insulat ion) are unsafe for both workers and future users of the facilities as residues can present health hazards, especia lly to ch ildren.

• Occupational and Community Health and Safety Risks. Construction typically presents risks of physical injuries such as fa lls, crushes, and cuts to construction workers, as well as toxic hazards resu lting from exposures cement dust, paints and so lvents. Where access to a site is not well-control led, these risks may extend to the community as well.

Operational issues include:

• General impacts of facilities in operation: In operation, general/institutional facilities and compounds generate a set of waste streams (e.g., gray water, latrine discharge, solid waste). In general, if improperly managed, such wastes can contaminate ground and surface water, create breeding habitat for disease vectors, etc. For example, failure to design or mainta in appropriate drainage structures can



Contract 17

resu lt in standing water within the compound or on adjacent land. Local erosion, including damage to adjacent fields, and sedimentation of nearby surface wat ers can also result.

• If latrine design or a maintenance failure permits insects or other disease vectors free in-and-out access to the pit/tank, pathogens in human waste can be spread within the compound and to the nearby community. Similarly, spilling latrine waste during pump-out releases contained pathogens into the environment. Storing solid waste (usually a mixture of food scraps, packaging, and paper) in open containers creates breeding habit for and attracts disease vectors such as rodents.

The above risks and impacts increase with the scale of the facility. They also increase in the presence of complicating factors:

• The site/facility is within 30m of a permanent or seasona l stream or water body or within or near wetland or other sensitive habitat.

• The planned work will involve displacement of existing settlement/inhabitants.

• The site has an average slope of more than 5% and/or is heavily forested or in an otherwise undisturbed local ecosystem

• Failure to provide infrastructure for appropriate management of healthcare waste in facility construction/rehabilitation and failure to observe appropriate design standards for sanitation provision can have significant adverse consequences.

Small-Scale Construction

• Potential impacts of facilities construction and operation in locations smaller than 1000 m2 present low risks when good design and construction practices are followed . This includes undertaking reasonable due diligence with regard to materials sourcing by construction general contractors (GCs) .

• The Implementing Partner will have direct cont ro l over its general contractors (GCs), construction materials are often procured by GCs from sub-vendors. In the case of timber, the sub-vendors are often at the end of a long and untraceable supply chain. This separation from source both limits the actions that the IP can take to assure environmentally responsible sourcing of these materials and



~~ract ~

reduces the project's responsibility for these impacts. Additionally, for the relatively small construction projects anticipated under t his program, adverse impacts related to materials sourcing should be limited.)

5. Procurement, storage, - Acute human health impacts of pesticide exposure range from distribution, use and headaches and nausea to severe poisoning, including coma and management of pesticides death. Chronic impacts can include cancer, reproductive harm,

and endocrine disruption. Pesticides can also have detrimental effects on the environment. Some can accumulate in water systems, pollute the air, and in some cases, have other negative environmental effects.

- Human health and environmenta l risks and impacts are extremely specific to, inter alia, the active ingredient being used, its concentration, formulation, mode of use, technique of application, and precautions and practices employed. For this reason, 22 CFR 216.3{b) requires:

1) Specific approval for pesticide use on any USAID project; 2) Approval for specific pesticide(s) for specific uses(s); and 3) Analysis of 12 enumerated analysis (including the factors

listed above) must be used to inform any such approval.

LLINs

- Distribution of nets shou ld follow the LLIN policy as outlined in the Malaria Vector Control Programmatic Environmental Assessment and the Integrated Vector Management Programmatic Environmental Assessment, 2017; to ensure proper compliance for net distribution.

- LLINs have now essentially replaced conventional insecticide-treated nets in Africa. Conventional insecticide-treated nets (ITNs), requiring regular retreatment of insecticide, may stil l, however, be in use in the Greater Mekong Subregion.

- Poor quantification and inventory management of nets can lead to stockout of LLINs and reduction in coverage if undersupplied, or the theft or misuse of LLINs (i.e., nets used for non-public health purposes such as fishing) if oversupplied.

- Distribution of nets can result in the accumulation of old nets and net packaging. The IP should follow WHO recommendations for packaging of LLINs9 as well as the safe use and disposal of expired LLINs.

- Standard practice for LLINs is to provide community messaging and outreach regarding the proper use and repurposing of LLINs at the end of use. The use of LLINs for fishing is not acceptable due to adverse environmental impacts to water and sensit ive

9 http://www. who.i nt/mala ria/pu blications/atoz/recommen dations _ managem ent_l lin _pa ckagi ng_novl 1.pdf Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Health Supply Chain Program

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ecosystems. - Although rarely conducted, the IP may provide reverse logistics

{i.e., take-back) of unused LLINs supplies upon request. It is not feasible to collect used LLINs once distributed to end user. However, if requested to do so, the WHO has published recommendations for the safe use and disposal of expired LLINs (WHO 2014)10.For LLINs, this 12-factor analysis is satisfied by GH's Malaria Vector Control Proqrammatic Environmental Assessment (MVC PEA). On this basis, the MVC PEA establishes umbrella approval for procurement of WHO-approved LLINs.

Pest Control

• Pest contro l at project storage locations will include both contact and residual pesticide/rodenticide use.

• Handling and disposal of pesticide/rodenticide can introduce into the local environmental, both human and ecological, potentially toxic waste.

6. Procurement, insta llation, - In their operations, all hazardous waste treatment equipment and commissioning, management, installations themselves present hazards, particularly (but not and maintenance of only) when improperly operated or sited, or when the equipment hazardous waste treatment is mis-specified. Examples of these risks and impacts, which equipment and installations generally scale with treatment capacity or size, include:

• In management of infectious waste, worker exposure to pathogens, particularly in landfill, sewage treatment, and composting operations, and in the waste handling waste required for all treatment technologies.

• Community exposure to pathogens when infectious waste treatment is not effective, often spread by disease vectors such as flies, birds and rodents drawn to in-ground facilities and hazardous waste stockpiles.

• Toxic air emissions and toxic ash from incineration: 11

o Incineration of materials containing chlorine {e.g. PVC plastics) can generate dioxins and furans, which are human carcinogens and have been associated with a range of adverse health effects. Only modern incinerators, operating at 850-1,100 °C, fitted with special gas-cleaning equipment, and operated and maintained to specification, are able to comply with the international emission standards for dioxins and furans.

o Incineration of heavy metals or materials with high metal content {in particular lead, mercury and cadmium) can

10 http://www. who.int/ ma la ria/pu bl ications/atoz/who-recomme ndation-ma naging-old-lli ns-ma r2014. pdf

11 http://bmb.oxfordjournals.org/content/68/1/183.full


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lead to the spread of toxic meta ls in the environment. Only modern incinerators operating at 850-1,100 °C and fitted with special gas-cleaning equipment are able to comply with the internat iona l emission standards for dioxins and furans.

• Odors, litter, noise, and heavy traffic associated with central waste facilities.

- Because of the multiple concerns presented by incineration, the WHO policy of 2004 ca lls for the promotion of non-burn alternatives as a long-term strategy. These alternatives include autoclaving, microwaving, steam treatment integrated with internal mixing, and chemical t reatment. Due to t he specific concerns presented by dioxins, t he Stockholm Convention also requires that priority consideration be given to non-burn alternatives. 12

- While it is unlikely that GHSC-TA will frequently be responsible for operating (managing) hazardous waste t reatment equipment and installations, the project's decisions or influence over decisions w ith regard to equipment specifications, choice of technique, and siting (among other factors) are expected to have significant influence over the impacts of this equ ipment and these insta llations in operation.

- As such, and given that control of risks requires that choice of technique, equipment specifications, and siting (among other factors) require close attention to the specific need and context of use, activities in this category need subsidiary review conducted with attention to identifying and contro lling t hese risks, wit h such review becoming progressively more intensive as risks escalate.

Note: Construction of faci lities and infrast ructure associat ed with hazardous waste treatment equipment and installations is addressed in category 4.

12 https://noharm.org/sites/default/ files/lib/ downloads/waste/MedWaste Mgmt Developing Wor ld.pdf

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Hea lth Supply Chain Program

{formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance {GHSC-TA 1 Contract 21

2.6. RECOMMENDED DETERMINATIONS AND CONDITIONS

2.6.1. Recommended Determinations

Activity or Activity Category Recommended Determination

1. Systems strengthening Categorical exclusion, per 22 CFR 216.2{2)(c)(2)(i) technical assistance including Education, technical assistance, or training programs except to the strategic planning, design extent such programs include activities directly affecting the assistance for country supply environment (such as construction of facilities, etc) systems and data management 2. Capacity bui lding including Categorical exclusion, per 22 CFR training and improvement of 216.2(2)(c)(2)(i) technology systems Education, technical assistance, or training programs except to the

extent such programs include activities directly affecting the environment (such as construction of facilities, etc.)

3. Procurement, transport, Negative Determination, per 22 CFR 216.3(a)(2)(iii), subject to the storage and disposal of health following conditions: commodities, general medical

Procurement supplies and equipment, including disposal of 1) Conduct quantification analysis to determine supply needs and

nonhazardous or general develop a supply plan to meet current needs and minimize the

waste and hazardous oversupply of health commodities.

materials 2) No mercury-containing medical equipment (e.g., thermomete rs, sphygmomanometers) or commodities (e .g., dental amalgam)

Note: Procurement of goods may be procured or managed under GHSC-TA, nor may such

and services is not permitted equipment or commodities be recommended for use, except that

except as they relate to the IP may manage disposal of such equipment or commodities as

technical assistance under this a commissioned activity. Disposal is subject to the host-country

award. requirements and requirements below.

Storage/Warehousing

1) Storage and management of pharmaceuticals, general medica l supplies and commodities, and equipment must be in conformity with approved SOPs. This includes subcontracted warehousing operations.

2) Training and advising consignees on the SOPs developed for the safe and effective storage of commodities. GHSC-TA must advise consignees to store products per the manufacturer's Materials Safety Data Sheet (MSDS)* and train in best practices in warehousing.

Distribution

1) Transport of pharmaceuticals, general medical supplies and commodities, and equipment must be in conformity with



Contract 22

approved SOPs. 2) Distribution of products that may generate highly toxic waste can

only be to those consignees that can be reasonably expected to handle such commodities safely in storage, use, and disposal (i.e., in a manner generally equivalent to IP's own waste management plan)

3) Training and advising consignees on the SOPs developed for the safe and effective transport of commodities. GHSC-TA must advise consignees to transport products per the Manufacturer's Materials Safety Data Sheet (MSDS* and train in best practices in transportation.

Disposal

1) Handling, treatment, and disposal of nonhazardous (general waste) and hazardous wastes by TA must be per TA's approved Waste Management Plan (WMP). The WMP, which outline SOPs for managing waste processes and guidelines for budgeting, must be in accordance to international best practices (i.e ., WHO) and host country requirements. The WMP must be appropriate for the location and waste stream.

2) GHSC-TA must advise all consignees regarding the hierarchy of disposal for pharmaceuticals and chemicals if or when disposal is required due to expiration, failure to maintain appropriate storage conditions, or for any other reason:

a. The preferred method is return to the manufacturer.

b. If this is not possible, 13 then the next-preferred option is per WHO's Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies.

Consignees must be specifically advised regarding risks and safe post-use disposal methods of all high-toxicity products.

3) Provision of reverse logistics. GHSC-TA must, upon request, provide take-back services from consignees for all unused commodities supplied. Upon take-back, commodities come under the control of the TA project, and subject to all relevant requirements under this IEE, including with respect to QA/QC and

disposal.

*NOTES:

MSDS sheets are supplied by the manufacturer. They are also available on the internet using the active ingredient and MSDS as search terms.

13 For example, if the expired or spoiled pharmaceuticals are considered hazardous and as such, if transferred across frontiers,

become regulated and subject to the Basel Convention on the Control of Trans-Boundary Movements of Hazardous Wastes.

(http://www.basel.int/ Home/tabid/2202/Default.aspx).


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4. Construction and rehabilitation of infrastructure and facilities

Note: No construction is permitted except construction connected with modular warehouses and other units and nonstructural or cosmetic work for in-country structures.

1. Small sca le activities in this category, defined as those involving a total disturbed area equal to or less than 1,000m2

Negative Determination, per 22 CFR 216.3{a)(2)(iii), subject to the following conditions:

1) Conformity with the above-listed site and facility restrictions must be documented. 2) A design plan will be developed that includes the use of appropriate building materials and complies with international best management practices and host country laws and regulations. The use of materials known to cause health impacts, including asbestoscontaining materials, lead-based paint, and materials that off-gas unsafe levels of formaldehyde are not permitted. 3) The IP will develop an SOP for construction activities. Construction and rehabilitation will be undertaken in a manner generally consistent with international and USAID best management practices per the "Small Scale Construction" chapter of the USAID Sector Environmental Guidelines. (www.usaidgems.org/sectorGuidelines.htm). Considerations include, but are not limited to: control measures to minimize soil erosion, standing water, and storm water runoff, water source protection, vegetation and tree preservation and transplanting, wildlife habitat protection, site security, relevant occupational health and safety concerns, etc. 4) Asbestos. If the presence of Asbestos is suspected in a facility to be renovated, the facility must be tested for asbestos before rehabilitation works begin. Should asbestos be present, then the work must be carried out in conformity with host country requirements, {if any) and in conformity with guidance to be provided by the health team, in consultation with the MEO and REA. The IP will be responsible for providing PPE to workers. All results of the testing for asbestos shall be communicated to the COR. No asbestos may be used in construction or rehabilitation . 5) Paint. No lead-based paint shall be used. Paint will be stored properly so as to avoid accidental spills or consumption by children; empty cans will be disposed of in an environmentally safe manner away from areas where contamination of water sources might occur; and the empty cans will be broken or punctured so that they cannot be reused as drinking or food containers. 6) Waste handling equipment and infrastructure. USAID interventions must result in the facilities' possessing adequate infrastructure and equipment to appropriately handle the wastes they may generate. The determinations and cond itions of category 6 applies.



Contract 24

2. Medium to large scale activities in this category, defined as those involving a total disturbed area greater t han 1,000m2 on a given site

Positive Determination, per 22 CFR 216.3(a}(2)(iii), with resulting scoping study and, as necessary, EA developed and approved by the IDIQ COR and GH BEO:

5. Procurement, storage, Negative Determination, per 22 CFR 216.3(a)(2)(iii), subject to the distribution, and management following conditions: of pesticides LLINS

1) Distribution of nets should meet PM l's PM l's technical guidance. The IP should also refer to the IVM PEA for guidance for the distribution of LLINS as well as the WHO recommendations for packaging LLINs.

2) The IP will develop and implement a communication plan t hat includes a social and behavior change communication {SBCC) strategy to inform users on acceptable and unacceptable repurposing uses for LLINs. The IP must instruct recipients that using LLINs for something other than their intended use, e.g., fishing, is prohibited.

3) LLIN take-back. GHSC-TA project must, upon request, provide take-back from consignees for all unused LLI Ns. It is not feasible to collect used LLINs once distributed to end user. However, if requested to do so, the WHO has published recommendations for the safe use and disposal of expired LLINs {WHO 2014).

Pest Control

1) The use and disposal of residual pesticides/rodenticides in storage locations will be outlined in t he Implementing Partners' SOPs to avoid toxic exposure to humans and t he local ecological environment.

2) Pest control in warehouses and other storage fa cilit ies will not use phosphine or other forms of fumigation for pest control. Pest control w ill be conducted using contact or residual pesticide/rodenticide . The SOPs for operation of warehouses and storage faci lit ies wi ll need to address the proper application of pesticides/rodenticides and disposal of the resulting waste.

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Healt h Supply Chain Program

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6. Procurement, installation, For incinerators with capacities~ 200 lbs/hour and ~ 2000 commissioning, management, lbs/week14 and in-ground disposal facilities~ 100m3 capacity and maintenance of

Note: that multiple installations serving a facility that in total exceed hazardous waste treatment equipment and installations

these thresholds receive a positive determination; see below:

Negative Determination, per 22 CFR 216.3{a){2){iii), subject to the

Note that construction following conditions:

associated with hazardous 1} The USAID operating unit financing the activity must prepare a

waste treatment equipment supplemental IEE (SIEE} pertaining to the specific site and

installation is also subject to circumstance in question as part of the decision to finance an

the requirements of category incinerator. The GH COR must approve the SIEE approved with concurrence by the GH BEO prior to detailed design, procurement, or operation, The SIEE must be informed by relevant industry Environmental, Health and Safety Guidelines and require Best Management Practices. 15

2) If the SIEE results in a positive threshold determination, the operating unit must prepare a scoping statement and, as necessary, an EA. See below for scoping requirements pertaining to incinerators.

For incinerators> 200 lbs/hour or 2000 lbs/week and in-ground disposal facilities > 100m3 capacity

Positive Determination, per 22 CFR 216.3{a){2){iii), with resulting scoping study and, if necessary, an EA developed and approved by IDIQ COR and the GH BEO.

1) Scoping studies for incinerators must analyze, at a minimum: the waste stream content and quantity, required pollution control technology, capacity of the host country to manage and operate the incinerator to comply with environmental and health standards, estimated operating costs, and other factors that the GH COR and BEO may determine necessary to ensure successful operation of the incinerator.

2)The scoping study will outline the pollution control technology that will be required with the procurement to ensure that the incinerator operates within and does not exceed the WHO or host country air quality standards. The result of the scoping study may result in the preparation of a full EA. The scoping statement must be informed by relevant industry Environmental, Health and Safety Guidelines and Best Management Practices.16

14 Size definition for incinerators is based on US Clean Air Act Section 129(a)(2) implementing regulations ("Hospital Medical Infect ious Waste Incineration (HMIWI) Regulation"), and conservatively combines the "very small" weekly limit and the "small" pounds/hr limit. See e.g. http://www.combustionportal.org/hmiwi.html 15 http://www. ifc.org/wps/wcm/ connect/lcd72a0048855 7 cfbdf4ff6a6515bb18/Fi nal+-+Waste+Ma nagement +Facilities.pdf?MOD=AJ PE RES 16 http://www.ifc.org/wps/wcm/ connect/lcd72a00488557cfbdf4ff6a6515bb18/Fi na l++Waste+M a nagement+Facilities. pdf?MOD=AJ PER ES Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Global Health Supply Chain Program

(formerly Global Health Commodity Program) for the USAID Global Hea lth Supply Chain- Technical Assistance (GHSC-TA t ~n~ct 26

For hazardous waste treatment equipment and installations, other than incinerators and in-ground facilities

Negative Determination, per 22 CFR 216.3(a)(2)(iii), subject to the following conditions:

1) The IP will prepare SOPs that will address procurement and management of hazardous waste treatment other than incinerators and in-ground facilities and submit t he SOPs to the GH COR and GH BEO for review and concurrence. The SOPs sha ll identify characteristics and context of the equipment/insta llation and waste. The GH COR in consultation with the GH BEO will advise the IP of the requirements for any additional environmental review.

2) The work order and other planning information needed to ensure adequate environmental compliance must be completed for each specific instance of procurement, installation or operation of such equipment and installations, and must be approved by the GH COR and GH BEO before IP may proceed with the activity. If the result of the screening and review process defined by the form is that an SIEE or scoping study is required, the IP may not proceed until these analyses are completed and approved.


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain-Technica l Assistance (GHSC-TA 1 Contract 27

2.6.2 Recommended Conditions

The following standard conditions in section 1.4 consist of conditions for project implementation for all Global Health mechanisms as well as additional conditions developed specifically for this project.

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

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

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

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

5. Integration of compliance responsibilities in prime and subcontracts, agreements, and grants. The COR shall ensure that contract documents reference and require compliance with the conditions set out in this IEE, as required by ADS 2014.3.4{a){6) and ADS 303.3.6{3){e). The Implementing Partner shall assure that subcontracts, agreements, and grants reference and require compliance with relevant elements of these conditions .

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

The Implementing Partner is responsible for annually preparing and submitting to the COR an Environmental Mitigation and Monitoring Report {EMMR) to document compliance with the conditions of this IEE. The EMMR must be submitted to the COR within 60 days after the end of each fiscal year. The EMMR template is attached to the IEE.

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


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assista nce (GHSC-TA t ~~ct ~

the EMMR) with the workplan.

If activities outside the scope of this IEE are planned, the COR sha ll assure that an amendment to t his IEE addressing these activities is prepared and approved prior to implementation of any such activities. Any ongo ing activities found to be outside the scope of this IEE shall be modified to comply or halted until an amendment to this IEE is submitted and approved.

8. Pesticides or pesticide products. Any program activities conducted under this Agreement involving the procurement, use, research or disposa l of pesticides and/or larvicides, (other than WHO-approved LLINS) and their waste products will require a supplemental IEE, SEA, or PERSUAP based on consultations with the Bureau Environmental Officer for Global Hea lth. Smal l sca le and routine use of contact pesticide/rodenticide is excepted, although their management and disposal is to be addressed in the SOPs for core activities.

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

10. Compliance with human subject research requirements. The COR in consultation with t he BEO for the Global Health Bureau sha ll assure that the Implementing Partner and sub-awardees demonstrate completion of all requirements for ethics review and adequate medica l monitoring of human subjects who participate in research trials ca rried out through this agreement. The BEO for Global Health may request copies of documentation from the COR to demonstrate compliance with applicable requirements of human subject trials. All documentation demonstrating completion of required review and approval of human subject trials must be in place prior to initiating any trials and cover the period of performance of the trial as described in the research protoco l.

11. Development and implementation of SOPs. The Implementing Partner will be responsible for preparing Standard Operating Procedures (SOPs) for co re responsibilities that have potential to result in environmenta l impacts w hich include but are to limited to operation of warehouse facilities, transportation of hea lthca re commodities, inventory management, general and hazardous waste management and disposa l, other operationa l activities as ident ified. These SOPs must be approved by the COR and reflect properly-referenced industry best practices.

12. Solicitation of international transport and disposal of hazardous waste. The solicitation of third party services for the international transport and disposal of hazardous and potentially haza rdous waste, including unusable pharmaceuticals and other health commodities, requires prior review and approval of solicitation documents by the COR and concurrence by the GH BEO.

13. Interim Environmental Compliance Review. Within t he fi rst four years after t he kick-off meeting/beginning work, the COR and GH BEO w ill set a date for t he project to undergo an environmenta l compliance review (ECR) to determine compliance with 22 CFR 216 requirements

Amendment No.1 to the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAMINATION or the Globa l Health Supply Cha in Program

(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA 1 ~~ct ~

and the conditions of this IEE. The scope of the ECR will be developed by t he GH BEO and submitted to the COR for review and concurrence. The GH Technical Offices will fund the ECR and provide access to project records as needed to conduct the review.

14. Closeout of activity, environmental responsibilities. The Implementing Partner will prepare a closeout plan consistent with contract documentation for COR review and approval that outlines responsibilities for end-of-project operation clean-up and disposal of healthcare, and other wastes, and/or transition of other operationa l responsibilities. Where identified as needed, the closeout/transition operation will provide training to support continuity of environmental responsibilities.

15. Waste Management Plan. If an Implementing Partner will be managing an activity that generates waste streams, the Implementing Partner will prepare or use an existing integrated Waste Management Plan (WMP) that will define and detail direct and indirect waste streams generated by IP-managed activities and specify appropriate management and disposal practices for each. The primary components required in a WMP are described in Annex B.

16. Mercury-containing commodities. The IP will not procure mercury-containing commodities. Any exception to the restriction must be submitted in writing with the justification to the COR for approval.

17. Asbestos and lead-based paint. The IP will not use construction materials containing asbestos or lead-based paint. When conducting renovation on existing buildings, the IP will investigate for the presence of asbestos or lead paint prior to initiating work and will provide appropriate PPE and a disposal process for handing the hazardous waste, if identified.

18. Air pollution control technology for incinerators. IP procurement or operation of large sca le incinerators, see Sections 1.3 and 2.6.1 of this IEE for size thresholds, must contain adequate air pollution contro l technology to ensure compliance with host country guidelines and applicable international air quality emission requirements, including:

• 74 FR 51367: US Environmental Protection Agency. Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Hospital/Medical/Infectious Waste Incinerators; Final Rule. October 6, 2009.

• Directive 2000/76/EC: Of the European Parliament and of the Council of 4 December 2000 on the incineration of waste.

• AP 42 and Emission Factors: US Environmental Protection Agency.



14.1. MONITORING AND REPORTING

The IP and the COR, in consultation with the BEO, will actively monitor and evaluate whether environmental consequences unforeseen under activities covered by this IEE arise during implementation and modify or end activities as appropriate. Monitoring and reporting will be documented via the Environmental Mitigation and Monitoring Template {EMMT), provided as Annex A to this IEE.

The EMMT consists of three parts:

• The Environmental Screening Form

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

• The Environmental Mitigation and Monitoring Plan {EMMP)

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

• The Environmental Mitigation and Monitoring Reporting (EMMR)

Annually, the Implementing Partner is responsible for completing the Environmental Mitigation and Monitoring Report {EMMR) and submitting it to the COR. The EMMRs are reviewed by the COR (or MEO, as appropriate) . The EMMRs ensure compliance with 22 CFR 216 and ADS 204.5 by documenting that the conditions specified in this IEE have been met for all activities carried out under GHSC-TA by reporting on the results of applying the mitigation measures described in the EMMP and identifying outstanding issues with respect to required cond itions. Verification may require digital photos and/or site visits.

The Implementing Partner for GHSC-TA will submit the EMMR on all activities within 60 days after the end of each fiscal year for the life of the project, using the guidance and forms conta ined in the GH IEE BOP. Any sub- awards, sub-grants, and sub-activities must incorporate provisions stipulating a) the completion of an annual environmental monitoring report and b) that activities to be undertaken will be within the scope of the environmental determinations and recommendations of this IEE. This includes assurances that any mitigating measures required for those activities wil l be followed. Refer to the attached GH EMMR Template.

Amendment No.1 t o the PROGRAMMATIC INITIAL ENVIRONMENTAL EXAM INATION or t he Global Health Supply Chain Program


Contract 31


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA }

Contract 32

Annex A: BUREAU FOR GLOBAL HEALTH

Environmental Mitigation and Monitoring Template (EMMT)

The Environmental Mitigation and Monitoring Template (EMMT) consists of three sections,

provided on the following pages:

1. Environmental Screening Form

2. Environmental Mitigation and Monitoring Plan (EMMP)

3. Environmental Mitigation and Monitoring Report (EMMR)

The EMMR is the annual report which documents the monitoring of mitigation

measures and their effectiveness.

Revision Date: August 19, 2016

Version: 4.0

Responsible Office: GH Office of

Policy, Programs and Planning

File Name: EMMT


{formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technica l Assistance (GHSC-TA 1 Contract 33

PART 1: Environmental Screening Form :

Global Healt h Supply Chain-Technical Assistance (GHSC-TA}

Project Name: Original IEE File #/DCN:

Name of Prime Implementing Organization : Date of Screening:

Name of Sub-awardee Organization (if this EMMT is for a sub): Funding Period for this aw ard:

FY __ -FY - -

Geographic location of USAID-funded activities (Province, District) : Current FY Resource Levels:

FY

This report prepared by: Date of Previous EMMT for t his

Name: organization (if any):

Date:

Indicate which activities your organization is implementing.

Key Elements of Program/Activities Implemented Yes No

1 Education, Technical Assistance, or Training

Includes: strategic planning, data analysis, technical consultation, surveys, knowledge and

information transfer, meet ings, technical materia l development, outreach programs, and

training services.

2 Research and Developr:nent

Includes: health-relat ed research and development activities aimed at advancing knowledge

and technology, including research and evaluation, monitoring and surveilla nce, programs, pilot studies, case studies, and assessments.


(formerly Global Health Commodity Program) for the USAID Global Health Supply Chain- Technical Assistance (GHSC-TA t Contract 34

3 Public Health Commodities

Includes: procurement, storage, transportation, distribution, and disposal of public health

commodities, including pharmaceuticals, nutritional supplements, chemicals (e.g.,

disinfectants, solvents, laboratory reagents, etc.), medical supplies, and family planning

commodit ies (e.g., contraceptives, condoms, etc.).

4 Small-Sca le Construction or Rehabilitation

Includes: hospitals, clinics, laboratories, voluntary and counseling testing centers, or training

centers. Total surface area of the disturbed environment is under 10,000 square feet and less

than $200,000 total cost.

5 Small-Scale Water and Sanitation

Includes: pond and spring improvements and installation of hand-dug wells, individual or

community latrines, hand-washing stations, and small-scale septic and leach fie ld systems.

6 Nutrition

Includes: small-scale food production, procurement and distribution of supplements,

preventing undernutrition, providing nutritional care and support, and improving nutritional

outcomes in programs.

7 Vector Control

Includes: procurement, distribution, or use of pesticide products such as insecticide-treated

bednets, larviciding agents, and fumigants.

NOTE: USAID uses USEPA's definition of pesticides, which includes "any substance intended

for: preventing, destroying, repelling, or mitigating any pest. This includes herbicides,

fungicides, plant regulators, and desiccants."

Emergency Response

8 Includes: coordination with outside organizations and technical experts, deployment of

resources and response teams, and development of technical materials.

DESCRIPTION OF ACTIVITIES:

Provide a concise description of activities w ith sufficient details to understand the scope and scale of the

interventions. The EMMP should reference the governing IEE (GH- or country-level).


(formerly Global Health Commodity Program) for t he USAID Globa l Health Supply Chain- Technical Assistance (GHSC-TA ~

Contract 35

PART 2: Environmental Mitigat ion and Monitoring Plan

Globa l Health Supp ly Chain-Technica l Assistance (GHSC-TA)

Add Introduct ion and additional narrative here, as needed.

Category of Activity Describe specific environmental

from Section 2.6 of threats of your organization's Description of Mitigation Measures

GHSC-TA IEE activit ies (based on analysis in for these activities as required in

Section 2.5 of the GHSC-TA IEE) Section 2.6 of GHSC-TA IEE

1. Education,

Technical Assistance,

Training

2. Research and

Development

3. Public Health

Commodities

4. Small-Scale

Construction

5. Small-Scale Water

and Sanitation

6. Nutrition

7. Vector Control

8. Emergency

Response

Programmatic Initial Environmental Examination

USAID Global Health Supply Chain-Procurement and Supply Management (GHSC-PSM)

Who is Monitoring Monitoring Frequency of

responsible for Indicator Method Monitoring monitoring?

36

Prepared by:

Signatur1 Date: ---------Name and Titl

Reviewed and Approved by:

!:;ignature Date:. _______ _

Contracting Officer's Representative

Concur:

Signaturi Date: _______ _

GH Bureau Environmental Officer


USAID Global Health Supply Chain-Procurement and Supply Management (GHSC-PSM} 37

PART 3: Environmental Mitigation and Monitoring Report

Globa l Health Supply Chain-Technical Assistance (GHSC-TA)

Add Introduction and additional narrative here, as needed.

List each Mitigation Measure from co lumn 3 in the

EMMP Status of Mitigation Measures

(EMMT Part 2 of 3)

1. Education, Technical Assistance, Training

2. Research and Development

3. Public Health Commodities

4. Small-Scale Construction

5. Small-Scale Water and Sanitatio n

6. Nutrit ion

7. Vector Control

8. Emergency Response

Prepared by:

SiJmatu_ra

Name· and Trt:le


USAID Global Health Supply Chain-Procurement and Supply Management (GHSC-PSM)

List any outstanding issues relating to required Remarks

conditions

Date:. _______ _

38

Annex B: Waste Management Plan Requirements The GHSC-TA contractor must develop an integrated Waste Management Plan (WMP) that will define

and detail direct and indirect waste streams generated by GHSC-TA managed activities, and specify

appropriate management and disposal practices for each. The waste management plan must:

• Classify and require management of each commodity the project proposes to procure or manage by level of risk, as per WHO guidance.

• Require assessment of local disposal options and requirements and identify, on a country basis, the disposal option for each class of commodity TA will procure or manage, as well as for general non-contaminated packaging. The disposal options identified will comply with loca l requi rements and be genera lly consistent with the fo llowing guidelines and resources:

o Pharmaceutica ls and chemica l wastes-WHO Safe Management of Wastes from Healthcare Activities See particularly 8.11, "Applications of treatment and disposal methods to specific waste categories."

o Non-contaminated packaging and general waste-USAID Sector Environmental Guidelines: Solid Waste.

o Pesticide wastes - FAO International Code of Conduct on the Distribution and Use of Pesticides: Guidelines on Management Options for Empty Pesticide Containers.

• Require compliance Basel convention on the control of transboundary movement of hazardous wastes and their disposal: http://www.basel.int/porta ls/4/basel%20convention/docs/text/baselconventiontext-e.pdf

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

• Incorporate appropriate monitoring and continuous improvement mechanisms

• Specify the process for managing the transportation and potential international sh ipment of hazardous waste for disposa l. If the international disposal of hazardous waste is to be conducted by a third party, the Request for Proposal (RFP) for these 3rd party services for the internationa l shipment must be approved by the GH COR with concurrence by the GH BEO. Solicitation of services for international exportation of hazardous material for disposal may not be initiated without approval of the RFP.

pg.39 at

Annex C: References and Resources 22 CFR 216: http://www.usaid.gov/our work/environment/compliance/22cfr216

ADS 200: Introduction to Programming Policy:

http://www.usaid.gov/sites/default/files/documents/1870/200.pdf

ADS 204: Environmental Procedures:


ADS 300: Agency Acquisition and Assistance (A&A) Planning:

http://www.usa id.ga"v/sites/default/files/documents/1868/300.pdf

ADS 302: USAID Direct Contracting: http://www.usaid.gov/sites/default/files/documents/1868/302.pdf

ADS 308: Awards to Public International Organizations:


ADS 502: USAID Records Management Program:


Bureau for Global Health Project Design and Approval Guidance

Environmental Compliance: Language for Use in Solicitations and Awards, An Additional Help to ADS

204: http://www.usaid.gov/sites/default/files/documents/1865/204sac.pdf

Executive Order 12114: Environmental Effects Abroad of Major Federal Actions:

http://www.archives.gov/federal-register/codi fication/executive-order/12114.html

Executive Order 13677: Climate-Resilient International Development : https://www.whitehouse.gov/the

press-office/2014/09/23/executive-order-climate-resilient-international-development

Foreign Assistance Act: http://www.usaidgems.org/lawsRegsPolicies/faa.htm

National Environmental Policy Act:

https://ceq.doe.gov/laws and executive orders/the nepa statute .html

USAID Sector Environmental Guidelines: http://www.usa idgems.org/sectorGuidelines.htm

pg. 40 at

Documents

s[+lci - ecd.usaid.gov · initial environmental examination global health supply chain program -technical assistance (ghsc-ta) amendment no. 1 1. executive summary 1.1