Attachment J.9 - GH-23-10993_IEE_STRIDES.pdf

INITIAL ENVIRONMENTAL

EXAMINATION

PROJECT/ACTIVITY DATA

Project/Activity Name: STrengthening Infectious Disease DEtection System (STRIDES)

Geographic Location(s) (Country/Region): Global Amendment (Yes/No), if Yes indicate # (1, 2...): No Implementation Start/End Date (FY or M/D/Y): Estimated FY 2024

If Amended, specify New End Date:

Solicitation/Contract/Award Number(s):

Implementing Partner(s):

Bureau Tracking ID: GH-23-10993 Tracking ID of Related RCE/IEE (if any):

Tracking ID of Other, Related Analyses:

ORGANIZATIONAL/ADMINISTRATIVE DATA

Implementing Operating Unit(s):

(e.g. Mission or Bureau or Office)

Emerging Threats Division (GH/ID/ETD) and Missions

Other Affected Operating Unit(s):

Lead BEO Bureau: GH

Funding Account(s) (if available):

Original Funding Amount:

If Amended, specify funding amount: N/A If Amended, specify new funding total: N/A

Prepared by: Ian Mendenhall Date Prepared: 08/08/2023

ENVIRONMENTAL COMPLIANCE REVIEW DATA

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

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

IEE Expiration Date (if applicable): n/a Additional Analyses/Reporting Required: IWMP, EMMP(s), and Annual EMMRs and Environmental

Screening Forms Climate Risks Identified (#): Low ___#_2 Moderate ___# 6___ High # 0 Climate Risks Addressed (#): Low # 2 Moderate ___# 6__ High # 0 mailto:imendenhall@usaid.gov

THRESHOLD DETERMINATION AND SUMMARY OF FINDINGS

SUPPORT PROJECT/ACTIVITY SUMMARY

To support and strengthen surveillance, detection and analytical capacity of infectious diseases and antimicrobial resistance. Through STRIDES- STRengthening Infectious disease DEtection Systems, the U.S. Agency for International Development (USAID) seeks to build on previous work by assisting counties prioritized for the Global Health Security program of varying capacitates in countries in Africa, Asia, and the Latin America/Caribbean regions to support different discrete aspects of the infectious disease detection and analytic pipeline. The objective of this project is to improve the capacity in up to 50 countries to detect priority infectious diseases (which may include HIV, tuberculosis, malaria, neglected tropical diseases, and emerging and endemic zoonotic diseases) and antimicrobial resistance, which can be analyzed and shared to guide future prevention, detection, and response efforts. These objectives will vary from country to country based on their needs and the assessment of their Joint External Evaluation (JEE) scores. This will include support for limited risk assessment and prioritization of surveillance goals by country, support limited surveillance and laboratory detection at the national, provincial, and district levels, and to support both data management and analyses. In rare circumstances, low-grade renovations of laboratories may be included. Specifically, DAA will bolster the capacity of disease detection across multiple countries thereby strengthening regional and global responses to infectious disease outbreaks.

ENVIRONMENTAL DETERMINATIONS

Upon approval of this document, the determinations become affirmed, per Agency regulations

(22 CFR 216).

TABLE 1: ENVIRONMENTAL DETERMINATIONS

Projects/Activities Categorical Exclusion Citation (if applicable)

Negative Determination

Positive Determination

Deferral

Project/Activity 1: Research and Development Sub-activity 1.1: Strengthen field surveillance for infectious diseases

Sub-activity 1.2: Strengthen laboratory detection for infectious disease surveillance

Sub-activity 1.3: Strengthen data management and analysis

Sub-activity 1.4: Emergency outbreak activity

Project/Activity 2: Technical Assistance, Training, and Capacity Building

Categorical Exclusion per, 22 CFR 216.2(2)(c)(2)(i) Education, technical

2 Deferrals must be cleared through an Amendment to this IEE prior to implementation of any deferred activities.

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

assistance, or training programs except to the extent such programs include activities directly affecting the environment

Project Activity 3: Management of Public Health Commodities Sub-activity 3.1:

Quantification and/or Forecasting of PHC and Inventory Management

Sub-activity 3.2:

Procurement of PHC

Sub-activity 3.3: Operation and Maintenance of Storage Facilities Containing PHCs

Sub-activity 3.4: PHC Distribution and/or Transportation

Sub-activity 3.5: On-site Handling and Disposal of

HCW

Sub-activity 3.6: Off-site Transportation and/or Disposal of HCW

Project Activity 4:

Rehabilitation of laboratory facilities

CLIMATE RISK MANAGEMENT

Within the four activities described in the above table, the climate risk assessment is categorized as low/moderate. At this time, the project is at the design stage, and all activities listed are illustrative. Most expected activities/sub-activities present low risk (with a few moderate risks); please refer to the CRM table analysis in the Annex. The DAA project will include opportunities to strengthen climate resilience and address the identified risks at the project design stage and include appropriate language and references to the CRM within the solicitation and award.

BEO SPECIFIED CONDITIONS OF APPROVAL

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 BEO Specified Conditions of Approval.

USAID APPROVAL OF INITIAL ENVIRONMENTAL EXAMINATION

PROJECT/ACTIVITY NAME: STRIDES- STRengthening Infectious disease DEtection Systems

Bureau Tracking ID: ______GH-23-10993________________

Approval:

Megan Fotheringham, Office of Infectious Diseases, Acting Director [required]

Date

Clearance: Ankunda Kariisa 08/29/2023 Ankunda Kariisa, AOR/COR [required] Date

Concurrence:

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

DISTRIBUTION:

Bureau for Global Health, ghcompliancesupport@usaid.gov

Environmental Compliance Database, environmentalcompliancesupport@usaid.gov

9/1/2023 mailto:ghcompliancesupport@usaid.gov mailto:environmentalcompliancesupport@usaid.gov

INITIAL ENVIRONMENTAL

EXAMINATION

CONTENTS

1.0 PROJECT/ACTIVITY DESCRIPTION 6

1.1 PURPOSE OF the IEE 6

1.2 PROJECT/ACTIVITY OVERVIEW 6

1.3 PROJECT/ACTIVITY DESCRIPTION 6

2.0 BASELINE ENVIRONMENTAL INFORMATION 9

2.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT,

PHYSICAL, CLIMATE, SOCIAL, Threatened and ENDANGERED species) 9

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER

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

POLICIES, AND REGULATIONS 10

2.3 COUNTRY/MINISTRY/MUNICIPALITY ENVIRONMENTAL CAPACITY ANALYSIS (AS

APPROPRIATE) 10

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK 11

4.0 ENVIRONMENTAL DETERMINATIONS 15

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS 15

4.2 CLIMATE RISK MANAGEMENT 16

5.0 CONDITIONS AND MITIGATION MEASURES 17

5.1 CONDITIONS 17

5.2 AGENCY CONDITIONS 18

5.3 MITIGATION MEASURES 19

6.0 LIMITATIONS OF THIS INITIAL ENVIRONMENTAL EXAMINATION 27

7.0 REVISIONS 28

ATTACHMENTS: 29

1.0 PROJECT/ACTIVITY DESCRIPTION

1.1 PURPOSE OF THE IEE

The purpose of this document, in accordance with Title 22, Code of Federal Regulations, Part 216 (22 CFR 216), is to provide a preliminary review of the reasonably foreseeable effects on the environment of the USAID intervention described herein and recommend determinations and, as appropriate, conditions, for these activities. Upon approval, these determinations become affirmed, and specified conditions become mandatory obligations of implementation.

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

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

1.2 PROJECT/ACTIVITY OVERVIEW

To support and strengthen surveillance, detection and analytical capacity of infectious diseases and anti-microbial resistance. Through STRIDES- STRengthening Infectious disease DEtection Systems, the U.S. Agency for International Development (USAID) seeks to build on previous work by assisting counties prioritized for the Global Health Security program of varying capacitates in countries in Africa, Asia, and the Latin America/Caribbean regions to support different discrete aspects of the infectious disease detection and analytic pipeline. The objective of this project is to improve the capacity in up to 50 countries to detect priority infectious diseases (which may include HIV, tuberculosis, malaria, neglected tropical diseases, and emerging and endemic zoonotic diseases) and antimicrobial resistance, which can be analyzed and shared to guide future prevention, detection, and response efforts. STRIDES will focus on strengthening the capacity of host country diagnostic networks and surveillance systems to improve the detection and response to diseases of public health importance. A priority focus will be to enhance capacity at the sub-national and community levels.

These objectives will vary from country to country based on their needs and the assessment of their Joint External Evaluation (JEE) scores. This will include support for limited risk assessment and prioritization of surveillance goals by country, support limited surveillance and laboratory detection at the national, provincial, and district levels, procure and provide laboratory supplies and health care commodities, and to support both data management and analyses. In rare circumstances, low-grade renovations of laboratories may be included. Specifically, STRIDES will bolster the capacity of disease detection across multiple countries thereby strengthening regional and global responses to infectious disease outbreaks. These efforts will address gender in the support of local, national, and regional laboratories to detect infectious diseases in the field and in the laboratory.

1.3 PROJECT/ACTIVITY DESCRIPTION

There are four pillars envisioned for the project as noted in the results framework below: (1) diagnostic strengthening, (2) surveillance systems, including AMR, (3) data analysis and management systems and (4) emergency response. This project will accelerate and refine https://www.usaid.gov/our_work/environment/compliance/22cfr216 https://www.usaid.gov/ads/policy/200/201mal efforts to improve the host country capacity and readiness to detect and respond to disease priorities and future pandemics, using a One Health approach. Each pillar in the results framework is intended to be consistent with USAID’s priorities to improve global health and strengthen diagnostic health systems at national and subnational levels, and USAID’S Global Health Security (GHS) program in support of the USG national biodefense strategy. The Joint External Evaluation (JEE) tool kit 3.0 will be used to measure and evaluate progress in the Prevention, Laboratory Systems, Surveillance, and Response.

Consistent with the JEE 3.0 One Health approach under the category of disease detection, the project will focus on enhancing the capacity of national and sub-national laboratory detection and diagnostic networks, both human and animal laboratory systems, in addition to building environmental surveillance. This work is intended to increase the percentage of the population with access to quality laboratory services for diseases of public health importance. This project will assess existing laboratory capacity at national and sub-national levels by conducting public health and/or veterinary laboratory networks mapping (including private sector labs or universities as part of the referral network), together with the National Laboratory Directorates or other counterparts to assess laboratory capacity, geographic coverage, different biosafety levels and gaps (this could include mapping for different health sectors such as malaria). It will also conduct training and assess potential opportunities for innovation (e.g. solar panels to address climate change). STRIDES will strengthen detection and diagnostic network management capacity by conducting assessments of the host network in host countries to identify capacity, priorities, information flow, and oversight, in addition to diagnostic network subcomponents (equipment, supplies/commodities, training, transport and waste management). Reagents and equipment for this project will be purchased throughout the span of the project. STRIDES will also strengthen the network’s staff capacity and improve functionality (e.g. rapid testing, PCR, serology, AMR, genomic sequencing), but predominantly sub-national and point of care services. There will also be components on developing/strengthening/utilizing reporting tools and dashboards.

The project is positioned to work with host country counterparts to enhance surveillance systems, using events based (EBS) and indicator-based surveillance (IBS) systems, to detect events of significance for public health and health security. This project will work to strengthen and expand systems at the national and specifically sub-national and difficult to reach and/or hotspot areas. It will focus on assisting host government counterparts working within a One Health approach in incorporating an expanded number of symptoms and diseases (including AMR) and developing and improving interoperable information systems to more rapidly and effectively share data. The One Health focus on surveillance provides for an integrated system that incorporates the whole ecosystem approach encompassing, for example, the supply of diagnostic commodities and specimen transport systems. This will also cover antimicrobial resistance by establishing and implementing a surveillance system, consistent with WHO AMR standards and guidelines that enables host countries to monitor, track and prevent the spread of AMR. The project will focus on developing or enhancing guidelines and operational procedures for AMR systems as defined in the Global Action Plan for AMR. This will include working with host country counterparts to institutionalize data systems such as the WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS), which is a collaborative effort to standardize AMR surveillance. The project will support host country counterparts to develop and strengthen data collection and analysis relating to detection and diagnostic services and surveillance systems. This includes strengthening bioinformatic capacity, data management and quality, and supporting efforts to increase digitization and data sharing. STRIDES will also support emergency outbreak response to address diagnostic or surveillance needs through rapid response or surge capacity for diagnostic support on the ground. Field and laboratory capacity will be assessed and developed to strengthen responses to emergency outbreaks of infectious diseases. This will include rapid purchase, personal protective equipment and reagents to outbreaks sites and laboratories.

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

Project/Activity 1 — Research and Development Sub-activity 1.1 Strengthen field surveillance for infectious diseases This sub-activity will assess existing surveillance and sampling capacities in-country, while supporting limited surveillance or research studies to fill priority data gaps and refine surveillance targets. Sample referral and transport to labs will be enhanced. Early surveillance (e.g. wastewater and environmental) approaches will be established and/or enhanced. Assistance will be provided in developing a sustainable surveillance plan, while providing surge support in the case of outbreaks, epidemics, or pandemics.

1.2 Strengthen laboratory detection for infectious disease surveillance Disease Detection for Action will initially assess existing testing capacities and help to strengthen laboratory management capacity. This sub-activity will strengthen laboratory testing/screening capacities, including, but not limited to, conventional PCR, quantitative PCR, serology, antimicrobial resistance testing, known virus detection, genetic sequencing, and next generation sequencing.

Assistance will also be provided in the development of a laboratory sustainability plan. Laboratory surge support will be provided in the case of outbreaks, epidemics, and pandemics.

1.3 Strengthen data management and analysis

An assessment of existing bioinformatics and data management capacities, along with strengthening bioinformatics capacity and the required infrastructure. Data management and security will also be strengthened. Efforts to increase digitization and data sharing will be supported.

1.4 Emergency outbreak activity

Field and laboratory capacity will be assessed and developed to strengthen responses to emergency outbreaks of infectious diseases. This will include rapid purchase, personal protective equipment and reagents to outbreaks sites and laboratories.

Project/Activity 2 — Technical Assistance, Training, and Capacity Building This project would include teaching, training, and capacity building on best practices for the assessment of local, national, and regional disease detection at the level of the field and laboratory, with an additional focus on data management and data analysis for action.

Project/Activity 3 — Procurement of Healthcare Commodities and Equipment Sub-activity 3.1: Quantification and/or Forecasting of PHC and Inventory Management Reagents and equipment for this project will be purchased throughout the span of the project. These items have finite lifespans and must be used before they expire. The drawdown of reagents, management of inventory, and forecasting of purchasing will be required.

Sub-activity 3.2: Procurement of PHC Disease Detection for Action will procure, but is not limited to, equipment and reagents needed to be procured to fulfill the objective of the project. Host country and international regulatory, shipping and packing requirements must be met. Additionally, these products must be manufactured at plants that meet good manufacturing practices. Records of procurement must be maintained.

Sub-activity 3.3: Operation and Maintenance of Storage Facilities Containing PHCs Once the reagents and equipment have arrived, these items need specific conditions (such as temperature sensitive items requiring refrigeration or freezing). The electrical network and backup generators must be functional and the sites/labs where these PHCs are housed need to be sufficient to not jeopardize the viability of these items.

Sub-activity 3.4: PHC Distribution and/or Transportation After purchasing of reagents and/or equipment (whether locally sourced or by the primary implementer), these items will need to be distributed to the collaborating laboratories and institutes.

This will be done by motorized vehicles. Improper transport can reduce the quality of the items and fleet management, incident reporting and spill/accident response need to be in place.

Sub-activity 3.5: On-site Handling and Disposal of HCW The use of reagents from laboratory testing will need to be handled, stored, and treated and/or disposed of in a manner to minimize adverse health and environmental impacts. Workers handling these items will need to be trained in the on-site handling and disposal of HCW.

Sub-activity 3.6: Off-site Transportation and/or Disposal of HCW The field sampling component of this project will generate waste that will need to be transported to the closest collaborating laboratory that has the capacity to treat the waste. The transport may generate wastes (fuel and vehicle maintenance). The packaging and transport will expose workers and others and potentially impact health and the environment. Spill response measures will need to be in place in case of accidents resulting in spills.

Project/Activity 4: Rehabilitation of laboratory facilities The laboratories where activities will be performed need to meet specific biosafety and biosecurity standards, in addition to having the capacity to conduct infectious disease detection. This may include, but is not limited to, certifying biosafety cabinets annually, ensuring that doors have functioning locks, ensuring that surfaces in the lab are not made of permeable material. These items would need to be remedied to meet the standards of the DAA global biosafety and biosecurity plan.

Will this project/activity involve construction3 as defined by ADS 201 and 303? Yes☒ No☐

2.0 BASELINE ENVIRONMENTAL INFORMATION

1.1 LOCATIONS AFFECTED AND ENVIRONMENTAL CONTEXT (ENVIRONMENT, PHYSICAL,

CLIMATE, SOCIAL, THREATENED AND ENDANGERED SPECIES)

Disease Detection for Action is expected to focus activities globally). Priority countries include:

intensive support countries as designated by the interagencies. The final country selection will depend on: (1) host country interest and motivation; (2), availability of data; (3), receptivity of operational environments (including staff and institutional capacities); (4), opportunities to leverage USG and other partner investments; (5) availability of, global capacity assessments;

(6), likelihood of success, and (7) potential for knowledge and lessons learned to be used to address similar issues in other countries. Additional country and local information will be provided once specific activities and locations are identified.

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

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

2.2 APPLICABLE AND APPROPRIATE PARTNER COUNTRY AND OTHER INTERNATIONAL

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

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

• USAID: Healthcare Waste (2019)

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

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

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

• CDC and NIH: Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition (2020)

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

• Guidelines of the American Society of Mammalogists for the use of wild mammals in research (2011)

• Canadian Council on Animal Care guidelines on: the care and use of wildlife (2003)

• Applied Research and Ethic National Association (ARENA) Institutional Animal Care and Use Committee Guidebook

• USAID Sector Environmental Guidelines: Construction (2017)

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

2.3 COUNTRY/MINISTRY/MUNICIPALITY ENVIRONMENTAL CAPACITY ANALYSIS (AS

APPROPRIATE)

To develop country-specific environmental analyses, the IP(s) are expected to first draw from existing USAID or other country-level environmental analysis. The relevant USAID Mission Environmental Officers (MEOs) may also be consulted to provide additional resources or assistance.

To develop country-specific climate analysis, the IPs are expected to first draw from the USAID Climate links website, which provides country- and region-specific profiles on climate vulnerability, risk, and/or adaptation. The relevant USAID Mission Climate Integration Leads (CILs) may also be consulted to provide additional resources or assistance.

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

3.0 ANALYSIS OF POTENTIAL ENVIRONMENTAL RISK

PROJECT/ACTIVITY 1: RESEARCH AND DEVELOPMENT

TABLE 3A. POTENTIAL IMPACTS – PROJECT/ACTIVITY 1

Project/Activity Potential environmental and social impacts Project/Activity 1: Research and Development Sub-activity 1.1: Strengthen field surveillance for infectious diseases

To understand the presence, distribution, diversity and transmission dynamics of infectious diseases requires collection of samples from humans, animals and the environment. These activities require human-human contact, human-animal contact and human-environmental contact.

Human sampling presents environmental risks for waste management. This activity may involve procurement of reagents or chemicals that will need to be properly disposed of to protect the chemical and the environment. Improper management and storage of the reagents or chemicals pose risks to both the environment and human health. Transportation of workers and others handling healthcare waste may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts.

Sub-activity 1.2: Strengthen laboratory detection for infectious disease surveillance

The procuring of certain types of reagents, supplies, equipment may have an impact on the environment if not properly disposed. Detection activities may result in hazardous or highly hazardous medical waste which could pose risks to staff and/or the community if staff are not properly trained, materials are not properly managed and/or routinely monitored.

Procuring an oversupply of health commodities increases the probability of products expiring on the shelf and requiring disposal. With higher disposal requirements, damaged and expired chemicals and/or pharmaceuticals create a larger waste stream of potentially hazardous waste and associated environmental impacts. Disposing a larger amount of chemicals also creates greater entry points of chemicals to be diverted from the waste stream into the community for improper use.

Procurement or acceptance of donated health commodities that are defective, expired, or counterfeit may lead to public health impacts due to the potential use of commodities being unsafe and/or ineffective if used by consumers. Adverse health and environmental impacts may also occur if defective, expired, or counterfeit health commodities are not properly managed and disposed. Workers and others handling healthcare waste may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts.

Environmental risks include the spread of infectious agents from person or properties used during response efforts, and if there are needs to collect samples from animals, or humans, in sensitive habitats, this could unintentionally have short and long term impacts to threatened and endangered species due to untimely or invasive response actions; contamination of soil, sediment or groundwater due to the presence of infectious agents; chemical, etc. at the response site; and contamination of person, property and environment due to inadequate containment planning and implementation

Improper transportation, treatment, and disposal of healthcare waste may lead to adverse health and environmental impacts.

Workers and others handling healthcare waste may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts.

Environmental impacts may occur from the use of vehicles to transport wastes (e.g., fuel operation, maintenance, spills, etc.)

or traffic accidents resulting in spills.

Sub-activity 1.3: Strengthen data management and analysis

Data strengthening and analysis may involve procuring specific types of equipment to collect, store, and analyze said data.

There may be an impact on the environment if there improper transportation and disposal of these items may lead to adverse health and environmental impacts

Sub-activity 1.4: Emergency outbreak management

Human sampling presents environmental risks for waste management. This activity may involve procurement of reagents or chemicals that will need to be properly disposed of to protect the chemical and the environment. Improper management and storage of the reagents or chemicals pose risks to both the environment and human health. Transportation of workers and others handling healthcare waste may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts.

Procuring an oversupply of health commodities increases the probability of products expiring on the shelf and requiring disposal. With higher disposal requirements, damaged and expired chemicals and/or pharmaceuticals create a larger waste stream of potentially hazardous waste and associated environmental impacts. Disposing a larger amount of chemicals also creates greater entry points of chemicals to be diverted from the waste stream into the community for improper use.

Procurement or acceptance of donated health commodities that are defective, expired, or counterfeit may lead to public health impacts due to the potential use of commodities being unsafe and/or ineffective if used by consumers. Adverse health and environmental impacts may also occur if defective, expired, or counterfeit health commodities are not properly managed and disposed. Workers and others handling healthcare waste may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts.

Environmental risks include the spread of infectious agents from person or properties used during response efforts, and if there are needs to collect samples from animals, or humans, in sensitive habitats, this could unintentionally have short and long term impacts to threatened and endangered species due to untimely or invasive response actions; contamination of soil, sediment or groundwater due to the presence of infectious agents; chemical, etc. at the response site; and contamination of person, property and environment due to inadequate containment planning and implementation

Improper transportation, treatment, and disposal of healthcare waste may lead to adverse health and environmental impacts.

Workers and others handling healthcare waste may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts.

Environmental impacts may occur from the use of vehicles to transport wastes (e.g., fuel operation, maintenance, spills, etc.)

or traffic accidents resulting in spills.

PROJECT/ACTIVITY 2: TECHNICAL ASSISTANCE, TRAINING, AND CAPACITY BUILDING

TABLE 3B. POTENTIAL IMPACTS – PROJECT/ACTIVITY 2

Project/Activity Potential environmental and social impacts Project/Activity 2: Technical Assistance, Training, and Capacity Building

Categorical Exclusion

§216.2(c)(2)(i) Education, technical assistance, or training programs §216.2(c)(2)(iii) Analyses, studies, academic or research workshops and meetings

PROJECT/ACTIVITY 3: PROCUREMENT OF HEALTHCARE COMMODITIES AND EQUIPMENT

TABLE 3C. POTENTIAL IMPACTS –PROJECT/ACTIVITY 3

Project/Activity Potential environmental and social impacts Project/Activity 3: Procurement of Healthcare Commodities and Equipment Sub-activity 3.1: Quantification and/or Forecasting of PHC and Inventory Management

Procuring an oversupply of PHC increases the probability of products expiring on the shelf and the need for waste treatment and/or disposal. The larger the quantity of damaged and/or expired pharmaceuticals or chemicals, the greater the waste stream of potentially hazardous waste and associated environmental impacts. This can also lead to more entry points of pharmaceuticals/reagents being diverted from the waste stream into the community for improper and possibly hazardous consumption.

Sub-activity 3.2: Procurement of

PHC

Procuring an oversupply of health commodities increases the probability of products expiring on the shelf and requiring disposal. With higher disposal requirements, damaged and expired pharmaceuticals/reagents create a larger waste stream of potentially hazardous waste and associated environmental impacts. Disposing of large amounts of pharmaceuticals also creates greater entry points of pharmaceuticals to be diverted from the waste stream into the community for improper and possibly hazardous consumption. Procurement or acceptance of donated health commodities that are defective, expired, or counterfeit may lead to public health impacts due to the potential of these commodities being unsafe and/or ineffective if used by consumers. Adverse health and environmental impacts may also occur if defective, expired, or counterfeit health commodities are not properly disposed.

Sub-activity 3.3: Operation and Storage, Public Health commodities including laboratory

Maintenance of Storage Facilities Containing PHCs supplies, and reagents.

Wastes and Medical supplies: Laboratory reagents have specific storage time and temperature requirements and may expire or lose efficacy before they are used, particularly in remote areas where demand is low and/or infrequent. Pharmaceutical waste may also accumulate due to inadequacies in stock management and distribution and/or lack of a routine system of disposal.

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

Sub-activity 3.4: PHC Distribution and/or Transportation

Improper transportation of health commodities can result in reduction in quality of the commodities through inadequate temperature or humidity controls which decrease their quality or result in damaged or defective supplies. Environmental impacts may occur from the use of vehicles to distribute supplies (e.g., fuel operation, maintenance, spills, etc.) or if an accident or spill occurs during transportation that releases commodities to the environment. Unsecured vehicles can result in theft.

Sub-activity 3.5: On-site Handling and Disposal of HCW

This activity will generate waste. Improper training, handling, storage, treatment, and disposal of the waste generated in health care facilities or activities can spread disease through several mechanisms. Transmission of disease through infectious waste is the greatest and most immediate threat from healthcare waste. If waste is not treated in a way that destroys the pathogenic organisms, dangerous quantities of microscopic disease-causing agents- viruses, bacteria, parasites or fungi-will be present in the waste. These agents can enter the body through punctures and other breaks in the skin, mucous membranes in the mouth, by being inhaled into the lungs, being swallowed, or being transmitted by a vector organism. Workers and others handling HCW may be in direct contact with hazardous or highly hazardous waste during disposal activities, which could lead to health impacts. Disposal of waste via landfilling may lead to leaching of hazardous waste into the soil and surrounding water sources. In addition, improperly managed or unsecured landfills may allow scavengers to collect disposed health commodities and reuse them or circulate in the community, which could result in health impacts. Effects on aquatic life are a major concern in disposal of pharmaceuticals.

A wide range of pharmaceuticals has been discovered in fresh waters globally, and even in small quantities some of these compounds have the potential to cause harm to aquatic life.

Sub-activity 3.6: Off-site Transportation and/or Disposal of

HCW

Improper transportation, treatment and/or disposal of HCW may lead to adverse health and environmental impacts. Workers and others handling HCW may be in direct contact with hazardous waste during treatment and/or disposal activities, which could lead to health impacts. Environmental impacts may occur from the use of vehicles to transport wastes (e.g., fuel operation, maintenance) and/or traffic accidents resulting in spills.

TABLE 3D. POTENTIAL IMPACTS –PROJECT/ACTIVITY 4

Project/Activity Potential environmental and social impacts Project/Activity 4:

Rehabilitation of laboratories

This activity will generate waste. Environmental impacts associated with construction activities will depend on the size, location, and complexity of the project. Exposure to hazardous building materials during construction activities can result in health impacts to workers. Site conditions may also result in health and safety impacts to workers and nearby residents if work sites are not properly managed and secured.

Construction, rehabilitation, and/or demolition activities may generate debris and wastes that contain both non-hazardous and hazardous materials and require proper disposal and/or treatment. This may include chemicals, solvents, and materials containing toxic substances (e.g., asbestos, lead-based paint, formaldehyde). Workers and others handling construction, rehabilitation, and/or demolition debris and wastes may be exposed to hazardous materials if the appropriate personal protective equipment (PPE) is not used.

3.1 THREATENED AND ENDANGERED SPECIES

The activities proposed includes work in already developed areas, clinical settings, and existing infrastructure. Therefore, the activities are not likely to adversely impact threatened and endangered species, or their critical habitat. Activity level actions that include construction or infrastructure improvements should be assessed for the presence of threatened or endangered species, or their critical habitat. Any activity that may adversely impact threatened or endangered species or their critical habitat may not proceed without an Environmental Assessment.

4.0 ENVIRONMENTAL DETERMINATIONS

4.1 RECOMMENDED ENVIRONMENTAL DETERMINATIONS

The following table summarizes the recommended determinations based on the environmental analysis conducted. Upon approval, these determinations become affirmed, per 22 CFR 216.

Specified conditions, detailed in Section 5, become mandatory obligations of implementation, per ADS 204.

TABLE 4: ENVIRONMENTAL DETERMINATIONS

Projects/Activities Categorical Exclusion Citation (if applicable)

Negative Determinatio n

Positive Determination

Deferral

Project/Activity 1: Research and Development Sub-activity 1.1: Strengthen field surveillance for

X ☐ ☐

5 Deferrals must be cleared through an Amendment to this IEE prior to implementation of any deferred activities.

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

infectious diseases Sub-activity 1.2: Strengthen laboratory detection for infectious disease surveillance

X ☐ ☐

Sub-activity 1.3: Strengthen data management and analysis

X ☐ ☐

Sub-activity 1.4: Emergency outbreak management

X ☐ ☐

Project/Activity 2: Technical Assistance, Training, and Capacity Building

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

Project Activity 3: Procurement of Healthcare Commodities and Equipment Sub-activity 3.1:

Quantification and/or Forecasting of PHC and Inventory Management

X ☐ ☐

Sub-activity 3.2:

Procurement of PHC

X ☐ ☐

Sub-activity 3.3: Operation and Maintenance of Storage Facilities Containing PHCs

X ☐ ☐

Sub-activity 3.4: PHC Distribution and/or Transportation

X ☐ ☐

Sub-activity 3.5: On-site Handling and Disposal of

HCW

X ☐ ☐

Sub-activity 3.6: Off-site Transportation and/or Disposal of HCW

X ☐ ☐

Project Activity 4:

Rehabilitation of laboratory facilities

X ☐ ☐

4.2 CLIMATE RISK MANAGEMENT

This section summarizes the methodology used and findings of the CRM Screening, in accordance with ADS 201mal. The project design team, in consultation with the CIL, considered the potential effect of climate risks/stressors on the sustainability of the project (changing precipitation patterns, rising temperature, floods, droughts, fires, landslides, etc.) in addition to the impact of project activities on the climate (increased greenhouse gas emissions, land use changes, etc.). See Annex 1 for the complete CRM table

GH Office of Infectious Disease (OID) Emerging Threats Division (ETD) design team completed the CRM analysis by: (1) Consulting with ETD’s technical advisors and reviewing project-specific reports/data to identify any known climate risks and mitigation strategies that are applicable to ongoing ETD awards (2) Reviewing USAID’s country/regional climate risk profile fact sheets from Asia, East/West Africa, and Latin America and the Carribean; (3) Using the Climate Risk Screening and Management Tool, referencing the “Health Annex,” to assess climate risks and inform project design and (4) referencing CRM documentation for previously approved projects.

At this time, the project is at the design stage, and all activities listed are illustrative. A majority of expected activities/sub-activities present low risk (with a few moderate risks); please refer to the CRM table analysis in the Annex. The Disease Detection for Action project will include opportunities to strengthen climate resilience and address the identified risks at the project design stage and include appropriate language and references to the CRM within the solicitation and award documentation. Applicants will be encouraged to complete the Climate Risk Tool for any activities that meet the moderate to high-risk rating. ETD will continue to work with the implementing partners, once the projects are awarded, to address climate risk at the work planning level.

Per instructions in the solicitation and award documentation, the implementing partner will be expected to ensure that sub-grantees and subcontractors have the capability to implement CRM. The implementing partner will, if appropriate, provide orientation to sub-grantees and subcontractors on climate risk management. Per Mandatory Reference for ADS Chapter 201 Climate Risk Management for USAID Projects and Activities, implementing partners may integrate “documentation” of the benefits of taking action to reduce climate change impacts and/or increase adaptive capacity” in their performance monitoring in program elements with moderate or high-risk ratings.

5.0 CONDITIONS AND MITIGATION MEASURES

5.1 CONDITIONS

The environmental determinations in this IEE are contingent upon full implementation of the following general implementation and monitoring requirements, as well as ADS 204 and other relevant requirements.

5.1.1 During Pre-Award:

5.1.1.1 Pre-Award Briefings: As feasible, the design team and/or the cognizant environmental officer(s) (e.g., MEO, REA, BEO) will provide a pre-award briefing for potential offerors on environmental compliance expectations/responsibilities at bidders’ conferences.

5.1.1.2 Solicitations: The design team, in coordination with the A/CO, will ensure solicitations include environmental compliance requirements and evaluation criteria. A/CO will ensure technical and cost proposal requirements include approach, staffing, and budget sufficient for complying with the terms of this IEE.

5.1.1.3 Awards: The A/COR, in coordination with the A/CO, will ensure all awards and sub-awards, include environmental compliance requirements.

5.1.2 During Post-Award:

5.1.2.1 Post-Award Briefings: The A/COR and/or the cognizant environmental officer(s) (e.g., MEO, REA, BEO) will provide post-award briefings for the IP on environmental compliance responsibilities.

5.1.2.3 Workplans and Budgeting: The A/COR will ensure the IP integrates environmental compliance requirements in work plans and budgets to comply with requirements, including EMMP implementation and monitoring.

5.1.2.4 Staffing: The A/COR, in coordination with the IP, will ensure all awards have staffing capacity to implement environmental compliance requirements.

5.1.2.5 Records Management: The A/COR will maintain environmental compliance documents in the official project/activity file and upload records to the designated USAID environmental compliance database system.

5.1.2.6 Host Country Environmental Compliance: The A/COR will ensure the IP complies with applicable and appropriate host country environmental requirements unless otherwise directed in writing by USAID. However, in the case of a conflict between the host country and USAID requirements, the more stringent shall govern.

5.1.2.7 Work Plan Review: The A/COR will ensure the IP verifies, at least annually or when activities are added or modified, that activities remain with the scope of the IEE. Activities outside of the scope of the IEE cannot be implemented until the IEE is amended.

5.1.2.8 IEE Amendment: If new activities are introduced or other changes to the scope of this IEE occur, an IEE Amendment will be required.

5.1.2.14 USAID Monitoring Oversight: The A/COR or designee, with the support of the cognizant environmental officer(s) (e.g., MEO, REA, BEO), will ensure monitoring of compliance with established requirements (e.g., by desktop reviews, site visits, etc.).

5.1.2.16 Environmental Compliance Mitigation and Monitoring Plan: The A/COR will ensure the IP develops, obtains approval for, and implements Environmental Mitigation and Monitoring Plans (EMMPs) that are responsive to the stipulated environmental compliance requirements.

5.1.2.17 Environmental Compliance Reporting: The A/COR will ensure the IP includes environmental compliance in regular project/activity reports, using indicators as appropriate; develops and submits the Environmental Mitigation and Monitoring Reports (EMMRs); and completes and submits a Record of Compliance (RoC) describing their implementation of EMMP requirements in conjunction with the final EMMR or at the close of sub activities (as applicable). And where required by Bureaus or Missions, ensure the IP prepares a closeout plan consistent with contract documentation for A/COR review and approval that outlines responsibilities for end-of-project operation, the transition of other operational responsibilities, and final EMMR with lessons learned.

5.1.2.18 Corrective Action: When noncompliance or unforeseen impacts are identified, IPs notify the A/COR, place a hold on activities, take corrective action, and report on the effectiveness of corrective actions. The A/COR initiates the corrective action process and ensures the IP completes and documents their activities. Where required by Bureaus or Missions, ensure Record of Compliance is completed.

5.1.2.19 Threatened and Endangered Species: Activities that may adversely impact the continued existence of threatened or endangered species or their critical habitat are not authorized. Activity level actions that include construction or infrastructure improvements must be assessed for the presence of threatened or endangered species, or their critical habitat. Any activity that may adversely impact threatened or endangered species or their critical habitat may not proceed without an Environmental Assessment.

5.2 AGENCY CONDITIONS

5.2.1 Sub-award Screening: The A/COR will ensure the IP uses an adequate environmental screening tool to screen any sub-award applications and to aid in the development of EMMPs.

5.2.2 Programmatic IEEs (PIEE): PIEEs stipulate requirements for additional environmental examination of new or country specific projects/activities. The A/COR of any project/activity being implemented under a PIEE will ensure appropriate reviews are conducted, typically through a Supplemental IEE, and approved by the cognizant BEO.

5.2.3 Supplemental IEEs (SIEEs): An SIEE will be prepared for any new project/activity being planned which fall under a PIEE. The SIEE will provide more thorough analysis of the planned activities, additional geographic context and baseline conditions as well as specific mitigation and monitoring requirements.

5.2.4 Other Supplemental Analyses: The A/COR will ensure supplemental environmental analyses that are called for in the IEE are completed and documented.

5.2.5 Resolution of Deferrals: If a deferral of the environmental threshold determination was issued, the A/COR will ensure that the appropriate 22CFR216 environmental analysis and documentation is completed and approved by the BEO before the…