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FUNCTIONAL OBJECTIVE: INVESTING IN PEOPLE PROGRAM AREA: HEALTH IMPROVED HEALTH OUTCOMES FOR SOUTH AFRICANS Bilateral USAID South Africa Health Program INITIAL ENVIRONMENTAL EXAMINATION (IEE) 1

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Page 1: PROGRAM/ACTIVITY DATA: - United States Agency for ...  · Web viewExamples of opportunities are the training plans for healthcare clinic staff on VCT and PMTCT services, and assistance

FUNCTIONAL OBJECTIVE: INVESTING IN PEOPLE

PROGRAM AREA: HEALTH

IMPROVED HEALTH OUTCOMES FOR SOUTH AFRICANS

Bilateral USAID South Africa Health Program

INITIAL ENVIRONMENTAL EXAMINATION (IEE)

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INITIAL ENVIRONMENTAL EXAMINATION

&

REQUEST FOR CATEGORICAL EXCLUSION

PROGRAM/ACTIVITY DATA:Program/Activity Number: 674-003 IIPProgram Activity Title: Improved Health Outcomes for South AfricansCountry/Region: South Africa bilateral / Southern Africa Region

Functional Objective: Investing in People (IIP)Program Area HealthFunctional Objective: Development Objective 3: Improved health outcomes for peopleProgram Elements: IR 3.1: HIV and Tuberculosis (TB) infections reduced

IR 3.2 Increased sustainability of effective HIV/AID and TB response systemsIR 3.3 Improved care and treatment of vulnerable populations

Period Covered: FY 2014 through FY 2018 LOP Amount approximate 5-year funding level (in millions $US) $2,400:

2012 ($482); 2013 ($482); 2014 ($459); 2015 ($413); 2016 ($350); 2017 ($250)

IEE Prepared By: Weston Fisher and Kathleen Hurley, Global Environmental Management Support Project GEMS. [email protected], [email protected]

IEE Amendment (Y/N): NoSubmitted By: Charles Mandivenyi, RPPDO, Acting MEO; Patricia Mengech, DO 3 teamCurrent Date 13 September 2013Expiration Date 31 December 2018 (allows time to ensure a new or amended

IEE is in place, if program is extended)

Other Relevant Environmental Compliance Documentation: Annex 1: GoSA Healthcare Waste Procedures and GuidanceAnnex 2: Healthcare Waste Management for Small Scale Facilities: Minimal Program Checklist and

Action PlanAnnex 3: Additional Guidance for Installation of Park HomesAnnex 4: Subsidiary Environmental Review for Umbrella Grant Projects

ENVIRONMENTAL ACTION RECOMMENDED;

Categorical Exclusion X Negative Determination X

Positive Determination n/a Deferral n/a

ADDITIONAL ELEMENTS: Conditions:_X_ ERR/ERF: _X_ PVO/NGO:_X_ EMMP:_X_ Construction: __X__ Pesticides: __n/a__

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SUMMARY OF FINDINGS: Scope. This IEE addresses the entire portfolio of activities anticipated under the USAID/South Africa Health (DO3): Improved health outcomes for South Africans program. It applies to all health sector activities implemented under South Africa’s 2013-2017 CDCS. It replaces and supersedes the Mission’s previous Health IEE: Functional Objective: Investing in People Program Area: Health; except that ongoing activities operating with approved environmental mitigation and monitoring plans (EMMPs) may continue operating under those EMMPs.

Note Regarding Intervention Categories

USAID/South Africa’s health portfolio falls under DO3: Improved health incomes for South Africans and three Intermediate Results: IR 3.1: Human Immunodeficiency Virus (HIV) and tuberculosis (TB) infections reduced; IR 3.2 Increased sustainability of effective HIV and TB response systems; and IR 3.3 Improved care and treatment of vulnerable populations. Many types of interventions will be undertaken in more than one—and sometimes several— health “subsectors.” For example, storage, handling and disposal of pharmaceuticals may be supported in the TB, HIV/AIDS, MMC and Orphans and Vulnerable Children (OVC) areas, as may be medical waste disposal, and capacity building in waste handling and storage.

The potential adverse environmental and health impacts of concern for health care waste management; pharmaceutical storage, handling and procurement; and care provider training, etc. are similar across these health subsectors. Analyzing these impacts separately for each sub-sector would be redundant, and make for an inefficient and unmanageably long IEE.

For the purposes of environmental review and compliance, interventions in the USAID/South Africa bilateral health portfolio are therefore consolidated into nine (9) categories:

1. Health Care Waste Management (HCWM) 2. Procurement, storage, management, distribution and disposal of public health commodities &

equipment; strengthening public health commodity supply chain management.3. Construction4. Water and Sanitation for Health (WASH)5. Capacity Development/Training: a) prevention, care and treatment HIV/AIDS, TB and MDR-

TB; b) MCC; c) PMTCT, MCC, OVC and GBV6. Social marketing, Education and Behavioral Change Communication (BCC)7. Policy & strategy development (including formulation of clinical norms) 8. Health Systems Strengthening (HSS): studies, surveys/public health surveillance and other

data-gathering assessments, models, and capacity-building in support of all areas above. Dissemination of resulting information/lessons learned/best practices.

9. Umbrella Grant Mechanisms in support of Development Objective 3: Improved health outcomes for South Africans.

Recommended Determinations. The following table summarizes the recommended determinations for the South Africa Health portfolio, per the intervention categories established by this IEE for purposes of environmental review. For each, a link is provided to the activity descriptions, analysis of potential environmental impacts, and activity-by-activity determinations and conditions within section 3 of the IEE.

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Intervention Category Categorical Exclusion(s)

Negative Determination(s)

Positive Determination(

s)

Link to full

analysis1. Health Care Waste Management (HCWM)

(w/ conditions) Click here

2. Procurement, storage, management, distribution and disposal of public health commodities & equipment; strengthening public health commodity supply chain management.

(w/ conditions) Click here

3 Construction (w/ conditions) Click here

4. Water and Sanitation for Health (WASH)

(w/ conditions) Click here

5. Capacity Development/Training: a) prevention, care and treatment HIV/AIDS, TB and MDR-TB; b) MCC; c) PMTCT, MCC, OVC and GBV

(w/ conditions) Click here

6. Social marketing, Education and Behavioral Change Communication (BCC)

(w/ conditions) Click here

7. Policy & strategy development (including formulation of clinical norms)

Click here

8. Health Systems Strengthening (HSS): studies, surveys/public health surveillance and other data-gathering assessments, models, and capacity-building in support of all areas above. Dissemination of resulting information/lessons learned/best practices.

(w/ conditions) Click here

9. Umbrella Grant Mechanisms in support of Development Objective 3: Improved health outcomes for South Africans

(w/ conditions) Click here

This IEE does not address major construction or water and sanitation-related health activities or use of pesticides/insecticides/biocides, support for which would require amendment of this IEE or trigger an EA.

Categorical Exclusions are recommended for the classes of action listed below, because no environmental impacts are expected as a result of these activities. These fall under the following citations from Title 22 of the Code of Federal Regulations, Regulation 216 (22 CFR 216), subparagraph 2(c)(2) as classes of activities that do not require an initial environmental examination: (i) Activities involving education, training, technical assistance or training programs except to the

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

(iii) Activities involving analyses, studies, academic or research workshops and meetings; (v) Activities involving document and information transfers; (viii) Programs involving nutrition, health care, or family planning services except to the extent

designed to include activities directly affecting the environment (such as construction of facilities, water supply systems, waste water treatment, etc.);

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

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For specific intervention areas to which the Categorical Exclusions recommended above apply, see the discussion in Section 3.2. In particular, the Categorical Exclusions apply for the listed classes of action EXCEPT those involving the collection and/or analysis of blood or body fluid samples (per 22 CFR 216.2 (c)(viii) programs involving nutrition, health care, or population and family planning services).

G2G & GoSA long-term plans for HIV/AIDS related health care provision. For the purposes of implementation of this IEE, it will be important for the Health Program to regularly assess the degree to which GoSA will choose to continue to outsource HIV/AIDs services through NGOs or will shift to delivering these services directly through government employees. With talks of the “PEPFAR transfer” of the treatment portfolio and declining PEPFAR budget, it is important to know the Ministry of Health’s long term plan so that USAID can provide the right types of support and capacity building to all the GoSA to deliver HIV/AIDs services. See Section 1.1.

With respect to the management of healthcare waste, this IEE defers to the Government of South Africa Procedures and Guidance for Disposal and Treatment Methods Suitable for Different Categories of Health Care Waste ( Annex 1).

USAID South Africa Health team monitoring responsibility. As required by ADS 204.5.4, the Health team will actively monitor and evaluate whether the conditions of this IEE are being implemented effectively and whether there are new or unforeseen consequences arising during implementation that were not identified and reviewed in this IEE. If new or unforeseen consequences arise during implementation, the team will suspend the activity and initiate appropriate, further review in accordance with 22 CFR 216. USAID Monitoring shall include regular site visits.

For a full discussion, see Section 4.0, General Project Implementation and Monitoring Requirements.

LIST OF ANNEXES

Annex 1: Government Of South Africa Procedures And Guidance For Disposal And Treatment Methods Suitable For Different Categories Of Health Care Waste

Annex 2. Healthcare Waste Management For Small Scale Facilities: Minimal Program Checklist And Action Plan

Annex 3: Additional Guidance for Installation of “Park Homes”

Annex 4: Subsidiary Environmental Review Process

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APPROVAL OF ENVIRONMENTAL ACTION RECOMMENDED:

CLEARANCE:

Mission Director: Date: Cheryl Anderson

CONCURRENCE:

AFR Bureau Environmental Officer: Date: Brian Hirsch

Approved: _____ Disapproved: ____

FILE Nº: South_Africa_Bilateral_Health_DO_IEE)_FY2014_2018.doc

ADDITIONAL CLEARANCES:

Mission Environmental Officer: Date: Charles Mandivenyi (Acting)

Health Team Leader (Acting): Date: Roxanna Rogers

Regional Environmental Advisor: __/ edited and cleared/ Date: Sept. 13, 2013 USAID/Southern Africa (Acting) Walter I. Knausenberger

GH Environmental Officer: ____/cleared/_______________ Date: Sept. 9, 2013

Michael Zeilinger

Distribution List:USAID South Africa MEO, Southern Africa REAUSAID/South Africa Bilateral Health Team A/CORs and Activity Managers, who distribute to IPsUSAID/Southern Africa Regional Office of Acquisitions and AssistanceUSAID/Southern Africa Regional Program and Project Development Office (SA/RPPDO)

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ACRONYMS

ABC Abstinence, Be Faithful, Use a CondomADS Automated Directive SystemsANC Antenatal CareAOR Agreement Officer’s RepresentativeARV, ART Anti-retroviral (therapy, treatment)AT Assessment TeamBoR Boundary of ResponsibilityCBA Cost Benefit AnalysisCBO Community-Based OrganizationCDC U.S. Centers for Disease Control and PreventionCPHO Chief Public Health OfficerCOR USAID Contracting Officer’s RepresentativeDO Development ObjectiveDOH National Department of Health (South Africa)DOTS Directly Observed Therapy, Short Course (strategy for therapy of TB)DSD Department of Social DevelopmentE3 Economic Development, Education, and the Environment EA Environmental Assessment (document)EC Environmental ComplianceEGSSA USAID Environmental Guidelines for Small-Scale ActivitiesEIA Environmental Impact Assessment (process)EMMP Environmental Mitigation and Monitoring PlanEMMR Environmental Mitigation and Monitoring ReportEPI Expanded Program on ImmunizationEPTM Environmental Procedures Training ManualFBO Faith-Based OrganizationG2G Government to Government, direct budget support to host country agencies (USAID

Forward)GoSA Government of South AfricaHBC Home-Based CareHC Health CareHCF Health Care FacilityHCW Health Care WasteHCWM Health Care Waste ManagementHCWM-BR Health Care Waste Management Boundaries of Responsibility HCWMS Health Care Waste Management SystemHIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency SyndromeHSS Health Systems StrengtheningIC The “In-Charge” at a HC facility, or a unit within a facilityIEC Information, Education, CommunicationIEE Initial Environmental ExaminationIMCI Integrated Management of Childhood Illness

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IP Implementing PartnerM&E Monitoring and EvaluationMCH Maternal and Child HealthMEO Mission Environment Officer MMC Medical Male CircumcisionMI Manageable InterestsMP Mitigation PlanMRV Measurement, Reporting, VerificationNGO Non-Governmental OrganizationNHLS National Health Laboratory ServicesNIH U.S. National Institutes of HealthNVP Nevirapine, antiretroviral drug used to treat HIV-1 infection and AIDSOGAC Office of the Global AIDS CoordinatorOI Opportunistic InfectionOPH Office of Population and HealthOVC Orphans and Vulnerable ChildrenOVH Orphans and Vulnerable HouseholdsPACE Performance, Analysis, Communications, Evaluation Project PEPFAR President’s Emergency Plan for AIDS ReliefPHC Primary Health CarePLWHA People Living with HIV/AIDSPMTCT Prevention of mother-to-child transmissionPPP Public Private PartnershipsQA Quality AssuranceQA&IC Quality Assurance and Infection ControlReg. 216 Title 22, Code of Federal Regulations, Part 216 (USAID Environmental Procedures) REA Regional Environmental AdvisorRH/FP Reproductive Health/ Family PlanningRHAP Regional HIV/AIDS ProgramRIG Regional Inspector GeneralRTKs Rapid Test KitsSA South Africa bilateral (USAID)STI Sexually Transmitted InfectionTB TuberculosisUNAIDS United Nations AIDS ProgramUSAID United States Agency for International DevelopmentVCT Voluntary HIV Counseling and TestingWHO World Health Organization

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INITIAL ENVIRONMENTAL EXAMINATION

& REQUEST FOR CATEGORICAL EXCLUSION

PROGRAM/ ACTIVITY DATA:

Program/Activity Number: 674-003 IIPProgram Activity Title: Improved health outcomes for South Africans Country/Region: South Africa bilateral/ Southern Africa RegionFunctional Objective: Investing In PeopleProgram Area: HealthFunctional Objective: DO 3: Improved health outcomes for peopleProgram Elements: IR 3.1: HIV and Tuberculosis (TB) infections reduced

IR 3.2 Increased sustainability of effective HIV/AID & TB response IR 3.3 Improved care and treatment of vulnerable populations

1.0 Background and Program Description

1.1 PURPOSE AND SCOPE OF IEEThis IEE addresses the entire portfolio of activities anticipated under the USAID/South Africa Health Program. It applies to all health sector activities implemented under South Africa’s 2013-2017 CDCS. It replaces and supersedes the Mission’s previous IEEs; except that ongoing activities operating an approved environmental mitigation and monitoring plan (EMMP) may continue operating under that EMMP.

For purposes of analysis, this IEE synthesizes current and anticipated Health Program activities under the office’s various projects and initiatives into a set of nine (9) intervention categories, each of which contains a number of entailed activities. As with all IEEs, and in accordance with 22 CFR 216, it reviews the reasonably foreseeable effects of each activity on the environment. On this basis, this IEE recommends Threshold Decisions and, in some cases, attendant conditions, for these activities.

In addition, this IEE sets out project-level1 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.

This IEE is a critical element of a mandatory environmental review and compliance process meant to achieve environmentally sound activity design and implementation.

AOR/CORs are responsible for ensuring that the Mission Agreement Officer (AO) and/or Contracting Officer (CO) incorporate these conditions into all solicitation documents and, thereafter, into contracts, grants, cooperative agreements, or other implementing mechanisms. This especially important during the

1 The terms “activity” and ‘project” are used throughout this IEE per their standard meaning in environmental impact assessment, and NOT as per USAID’s new programming framework. As such, a project is a cluster of activities executed under a single, thematically focused prime contract or award; e.g. the ‘Agriculture Policy Strengthening (MAPS) Project.’ By contrast, in USAID’s new programming framework, “project” describes a sector- or sub-sector portfolio (e.g., Intermediate Results (IR) level), covering multiple contracts or awards, and “activity” denotes a single such contract or award (“implementation vehicle.”)

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Post Award Briefings and during workplan preparation and workplan reviews. Incorporation of environmental requirements in procurement documents ensures that Implementing Partners (IPs) apply environmental compliance issues during the design, planning, implementation, monitoring and evaluation of activities. The Program Office must be sure to incorporate these conditions in all G2G agreements.

Government-to-government (G2G) assistance. In keeping with USAID Forward, investment in government-to-government assistance is an important development objective. In order to pursue such opportunities USAID/South Africa will need to obtain Authorization for Use of Partner Country Systems (AUPCS)—a new requirement for G2G assistance specified in ADS 220 - Use of Reliable Partner Country Systems for Direct Management and Implementation of Assistance. This will include certification of the effectiveness of the GoSA’s environmental assessment procedures, policies, and legal/regulatory framework as well as their actual implementation. This certification likely will require that a capacity assessment be implemented to assure that host government systems are capable of ensuring sound environmental compliance and where gaps are identified appropriate capacity building measures will be recommended as conditionalities to the final approval of an AUPCS.  This also should be harmonized with the expectations of other sector donors (World Bank, EU, etc.), in line with the Paris Declaration of Aid Effectiveness.

1.2 PROGRAM BACKGROUND (CONTEXT & JUSTIFICATION) South Africa ranks 121 out of 187 countries on the Human Development Index (HDI) and faces a growing burden of disease and critical shortage of healthcare resources, similar to many countries in sub-Saharan Africa. The epidemiological profile is characterized by a high prevalence of communicable diseases including malaria, tuberculosis, and HIV/AIDS; high incidence of maternal and child health problems; and an increasing burden of non-communicable diseases. According to WHO estimates, South Africa has the largest AIDS epidemic in the world and ranks third in terms of TB burden. As a result, HIV/AIDS is a leading cause of morbidity and mortality in the country; about 5.75 million people are living with HIV. Under-five mortality rate (per 1000 births) is 59.8 while the adult mortality rate per 1000 adults is 496. In general, access to health services is very uneven throughout the country, and inequities exist between the public and private sector health care systems.

Currently, South Africa has the largest HIV/AIDS epidemic in the world with approximately 5.7 million people living with HIV. It also ranks third in the world in terms of TB burden according to WHO estimates, with an incidence of 948 new infections per 100,000 persons in 2010, which is compounded by high levels of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). The estimated number of confirmed MDR-TB cases among new pulmonary TB cases in 2010 was 7,386113. The high rates of co-infection (approximately 60 percent of TB patients are co-infected with HIV) lead to further expansion of the epidemics and complicate treatment and care of patients.

The socio-economic impact of HIV/AIDS in South Africa is significant. Educational outcomes are adversely impacted due to HIV/AIDS causing “… disruptions in schools because teachers are affected by HIV/AIDS and children living in households affected by HIV/AIDS may face obstacles or disadvantages in accessing education.”114 HIV/AIDS creates instability in employment and is thus a persistent drag on the economy and overall South African development goals in the short- and mid-term.

In 2010 the South African National AIDS Council (SANAC) conducted a “Know Your Epidemic” survey in all provinces. The report identified key biological, behavioral, social, and structural determinants of the HIV epidemic, as well as key populations and geographic areas where HIV prevalence is concentrated. It confirmed that the South Africa HIV epidemic is geographically heterogeneous and an effective response should be localized and sharply targeted.

The Partnership Framework in Support of South Africa’s National HIV and AIDS and TB Response (2012/13 – 2016/17) (PF) between the GoSA and the USG was signed by the South African Minister of

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International Relations and Cooperation and the United States Secretary of State on December 10, 2010. The PF commits the GoSA and USG to the following principles: South African leadership; alignment; sustainability; innovation and responsiveness to the epidemics; mutual accountability; multi-sectoral engagement and participation; gender sensitivity; financial commitments and transparency; and finally, fostering a collaborative and not contractual partnership. The goal and objectives of the GoSA/USG PEPFAR PF to prevent new HIV and TB infections; increase life expectancy and improve the quality of life for people living with and affected by HIV and TB; and strengthen the effectiveness of the HIV and TB response system115 support that aim.

The PF Implementation Plan (PFIP) forms the roadmap for the implementation of these principles and is guided by the “South Africa National Strategic Plan (NSP) for HIV, STIs and TB 2012 – 2016”, which was launched on December 1, 2011. The NSP extends over the same five-year period as the Partnership Framework. The NSP is a multi-sector national plan that lies at the heart of the development agenda of the South Africa Government. It calls on all government departments and civil society sectors to work together to achieve the national goals and targets for the HIV, STI, and TB epidemics. USAID, through funding from the PEPFAR program, supports the PFIP, which outlines how PEPFAR is to implement programs.

In order to support the ambitious goals of the NSP, the USG and GoSA have mutually decided that PEPFAR’s investments in South Africa should gradually transition from support of direct clinical care and treatment services to support for system strengthening, prevention, orphans and vulnerable children, and health services innovation. As the GoSA commits greater resources for the HIV/AIDS and TB response and PEPFAR funding declines, the transition is expected to be implemented in a manner that puts the well-being of patients and vulnerable and affected populations at the center of all interventions. While the GoSA continues to increase the number of patients on treatment through the public health system, PEPFAR intends to keep long-term sustainability and health and social systems strengthening as priorities that lead to increased efficiency in implementation of the national response.

The South Africa Global Health Initiative (GHI) strategy reflects a multi-year roadmap (2011-2016) that is in line with South African strategies and illustrates how the application of GHI principles will increase efficiencies, accelerate health outcomes, and use resources more efficiently. GHI will strengthen GoSA technical and managerial capacity to assume responsibility for implementing a strong HIV/AIDS prevention, care, and treatment program and to improve other health outcomes through stronger health and social systems.

USAID/South Africa’s health sector activities are a response to these human and development needs and are in line with the Government of South Africa’s national health goals to increase life expectancy, reduce maternal and child mortality, combat HIV/AIDS and decrease the burden of disease from TB, and strengthen the health system effectiveness by 2015 and the Partnership Framework in Support of South Africa’s National HIV and AIDS and TB Response (2012/13-2016/17) between the GoSA and USG. By the end of the five-year Partnership Framework Agreement (April 2017), South Africa will take responsibility for the care and treatment component of its national HIV/AIDS response.

Gender integration is of priority consideration in all USAID’s health programs to ensure the involvement of both women and men in leadership, planning, decision-making, implementation and assessment. Gender-based violence is also a Health Program focus. Increasing male involvement in HIV prevention, treatment and care is also a key element of the USAID program. Given the multi-faceted impact of the epidemic, the Health Program will continue to be multi-sectoral. Potential Climate Change (CC) impacts to health outcomes must also be factored into the Health Program’s environmental mitigation and monitoring strategy. The elements of USAID’s multi-sectoral approach are based on linkages between all Functional Objectives of the Mission.

Government of South Africa (GoSA) long-term plans for HIV/AIDS related health care provision.

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For the purposes of implementation of this IEE, it will be important for the Health Program to regularly assess the degree to which GoSA will choose to continue to outsource HIV/AIDs services through NGOs or will shift to delivering these services directly through government employees. With talks of the “PEPFAR transfer” of the treatment portfolio and declining PEPFAR budget, it is important to know the Ministry of Health’s long term plan so that USAID can provide the right types of support and capacity building to all the GoSA to deliver HIV/AIDs services.

1.3 HEALTH PROGRAM INTERVENTION CATEGORIES FOR PURPOSES ENVIRONMENTAL REVIEW

Many types of interventions will be undertaken in more than one—and sometimes several—health subsectors. For example, procurement of pharmaceuticals may be supported in the HIV/AIDS, TB and OVC areas, which may also include training of care providers and strengthening health care commodity supply chains.

The potential adverse environmental and health impacts of concern for pharmaceutical procurement, care provider training, etc. are similar across these health subsectors. Analyzing these impacts separately for each sub-sector would be redundant, and make for an inefficient and unmanageably long IEE. Therefore, for purposes of environmental review and compliance, interventions in the USAID/South Africa health portfolio are consolidated into the following nine (9) intervention categories:

1. Health Care Waste Management (HCWM) 2. Procurement, storage, management, distribution and disposal of public health commodities &

equipment; strengthening public health commodity supply chain management.3. Construction4. Water and Sanitation for Health (WASH)5. Capacity Development/Training: a) prevention, care and treatment HIV/AIDS, TB and MDR-

TB; b) MCC; c) PMTCT, OVC and GBV6. Social marketing, Education and Behavioral Change Communication (BCC)7. Policy & strategy development (including formulation of clinical norms) 8. Health Systems Strengthening (HSS): studies, surveys/public health surveillance and other

data-gathering assessments, models, and capacity-building in support of all areas above. Dissemination of resulting information/lessons learned/best practices

9. Umbrella Grant Mechanisms (UGMs) in support of Development Objective 3: Improved health outcomes for South Africans

Individual projects2 in many instances carry out activities in more than one sub-sector, and the projects are designed to be mutually supportive and synergistic so that the portfolio overall embodies an integrated approach.

2.0 Country and Environmental Information (Baseline Information)

2.1 SOUTH AFRICA PHYSICAL AND SOCIO-ECONOMIC PROFILESouth Africa is the southernmost country in Africa and covers 1,219,090 km of land with a population of 48.6mn. It completely surrounds Lesotho, almost completely surrounds Swaziland, and is bordered to the north by Namibia, Botswana, Zimbabwe, and Mozambique. To the west, south, and east, South Africa borders the Atlantic and Indian oceans. South Africa has three capitals; Pretoria, the administrative

2 See footnote 1 regarding use of the terms “projects” and “activities” throughout this IEE (Sect. 1.1).

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capital, Bloemfontein, the judicial capital, and Cape Town, the legislative capital and second largest city by population with 3.4 million people. Located in the northern Gauteng province, Johannesburg is the

The landscape is divided into two major categories: the interior plateau which stretches north to the Sahara desert, and the land between the plateau and the coast. The plateau itself is characterized by wide plains with the Great Escarpment being both the highest part of the plateau and the boundary between these two major areas. The climate is mostly semiarid with subtropical areas containing 530,000 ha of indigenous or natural forests along the southern and eastern escarpment and the coastal belt. The total forested area is about 1% of total South African land, employs around 201,000 people in the forestry industry and compromises 1.2% of GDP.

The ocean surrounds South Africa on three sides with the warm south-flowing Mozambique-Agulhas current meeting the cold Benquela current. The temperature contrast partly accounts for differences in climate, vegetation and marine life between the east and west coasts. The cold waters on the west coast are richer in oxygen, nitrates, phosphates and plankton, the foundation of the South African fishing industry. The country has no navigable rivers. Only the two largest rivers, the Orange and Limpopo, can maintain permanent channels through the large sandbars blocking river mouths for most of the year. The lack of important arterial rivers or lakes requires significant water conservation and control measures and also strains the relationship between water usage and supply. The USAID Country Development Cooperation Strategy (CDSC) notes that while supply is currently only 15 billion cubic meters, demand for water in South Africa will reach around 17.7 billion cubic meters by 2030. Rainfall is unreliable and unpredictable in South Africa, fluctuating between less than 500 mm per year to less than 200mm per year in the arid west. Below average rainfall is common and has periodically led to prolonged droughts followed by severe floods. The CDSC predicts that climate change will account for further declines in total precipitation throughout the country leading to additional water management challenges.

2.2 SOUTH AFRICA HEALTH SECTOR PROFILEDespite advances made in access to immunization and maternal, prenatal, and primary health care services, the South African public health care system is still overwhelmed by four major categories of Burden of Disease: high rates of HIV/AIDS, tuberculosis (TB), high maternal and child mortality, non-communicable diseases (NCDs) and Violence and Injuries. The World Health Organization (WHO) lists South Africa as having the largest AIDS epidemic in the world and the third largest TB burden. According to the USAID CDSC, 60% of TB patients are also co-infected with HIV, which complicates disease management.

While the rate of HIV infections stabilized after 2004, the rate of infected pregnant women and subsequent maternal death rates remain high. In 2010, the WHO found one-third of women who were treated in public health-care facilities were infected; in 2011, the majority of maternal deaths (70.4%) were associated with HIV infection. Children in South Africa are also significantly impacted by HIV/AIDS; approximately 22% of the country’s 18 million children are affected by HIV/AIDS and 35% of children’s mortality under age 5 is a result of HIV infection. This makes prevention of mother-to-child transmission (PMTCT) a critical priority for the South African government, which is struggling to reach Millennium Development Goals (MDGs) 4 and 5 relating to maternal and child mortality. A PMTCT program implemented in 2002 has decreased maternal and child mortality as treatment regimens have improved and HIV/AIDS testing is now virtually universal.

South Africa spends about 8.5% of GDP on health care, more than most developing countries. Despite this level of investment in the health care sector, South Africa continues to be afflicted by infectious disease and NCDs, which are on the rise in vulnerable sectors of the population. The CDSC notes that many South Africans with HIV and TB are also co-infected with NCDs like hypertension and diabetes.

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The WHO cites NCDs as accounting for 29% of all mortalities. Inequitable access to basic health services exacerbates the government’s struggle to restrict NCD’s among poorer rural communities.

Inequity in the health care system impacts access to care and resources; the majority of the population relies upon the underfunded and understaffed public sector health services. Medical professionals are more abundant in the private sector. For example, there is one general doctor for 243 patients in the private sector, while in the public sector one general doctor is available for 4,200 patients. The Primary Health Care Package for South Africa, a set of norms and standards for health clinics and community-based clinic services, aims to provide an essential package of primary care services to South Africans. A primary goal of the plan is to reduce inequalities in health care provision as well as guiding provincial and district health authorities that provide these services.

The current health sector strategy is the Negotiated Service Delivery Agreement (NSDA) between the presidency and the National Department of Health. With an overall goal of achieving “a long and healthy life for all South Africans”, the strategy focuses on achieving four specific outputs: increasing life expectancy, reducing maternal and child mortality rates, combating HIV/AIDS and TB, and strengthening the effectiveness of the health system. In 2012, the government published the National Development Plan (NDP) 2030 strengthening the commitment to disease control and public health access with the specific aim of increasing life expectancy to 70 years (currently at 57 for males and 60 for females). The MDGs are incorporated into these and other national policies and plans for healthcare. -------------------------------------

2.3 LOCATIONS AFFECTEDThe geographic scope of the bilateral integrated Health Portfolio is the entire country of South Africa; however, many interventions are regionally focused. Targeted regions include Gauteng, Limpopo, KwaZulu-Natal, Western Cape, Mpumalanga, Free State, and North West.

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Source: www.mapsopensource.com, 08/07/13

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2.4 SOUTH AFRICA’S ENVIRONMENTAL POLICIES AND PROCEDURESSouth Africa has an extensive framework of laws and policies governing the use and management of natural resources and the environment. The South African Constitution of 1996 grants every person the right to an environment that is “not harmful to their health or well-being as well as the right to have the environment protected through reasonable legislative and other measures that prevent pollution, ecological degradation, promote conservation, and secure ecological sustainable development and the use of natural resources while promoting justifiable economic and social development.” The foundational law is the National Environmental Management Act and the associated Protected Areas Act, Biodiversity Act, and Air Quality Act.

The National Environmental Management Laws Amendment Act (NEMLA Act 2013) was signed in July 2013 to strengthen the implementation of legal requirements and administrative processes to limit possible abuse of the permit system as it relates to hunting rhinoceros and other threatened or protected species.3 It amends the National Environmental Management: Air Quality Act (2004), the NEM: Waste Act (2008), the NEM: Protected Areas Amendment Act (2009), and the NEMLA of 2008. In addition to strengthening the permit system for hunting of threatened or endangered species, the NEMLA 2013 also provides a structure to properly regulate listed species and alien or invasive species. The amendment seeks to prevent over utilization of these species. NEMLA (2013) empowers the Minister to manage invasive species and respond to the threat of an invasive species more effectively.

The statues related to pollution management also regulate management of waste. The Hazardous Substances Act provides for the “control of substances which may cause injury or ill-health to, or death of, humans by their toxic, corrosive, irritant, strongly sensitizing, or flammable nature.” The Air Quality Act provides reasonable measures for pollution prevention and minimization of ecological degradation

3 http://www.info.gov.za/speech/DynamicAction?pageid=461&sid=38536&tid=115530

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through national norms and standards regulating air quality monitoring, management, and control. The National Water Act and the Occupational Health and Safety Act also have elements that apply to waste management.

Under the National Environmental Management Law, several acts govern management of natural resources and the environment. These include the following:

Biodiversity Act (2004) Waste Act (2008) Weather Service Act Marine Living Resources Act (1998) Environmental Impact Assessment Regulations (2010) Air Quality Act (2004, 2010) Integrated Coastal Zone Management Act (2008) Physical Planning Act (1967) Environment Conservation Act (2003, 2009) National Forests Act (1998) Protected Areas Act (2004) National Parks Amendment Act (1998) National Water Act (1998) Mountain Catchment Areas Act (1970) Minerals and Petroleum Resources Development Act

South African law requires that activities that may have a detrimental effect on the environment must apply for an authorization from the appropriate authority and prepare an environmental impact assessment. The environmental impact assessment describes the proposed activity, its potential impact on the environment, and provisions for management and monitoring for environmental impacts throughout the life cycle of the activity.

3.0 Potential Environmental Impacts & Recommended Determinations, Including Conditions

3.1 SUMMARY OF HEATH PROGRAM ACTIVITIES BY INTERMEDIATE RESULTS

Intermediate Result 3.1: HIV & TB infections reduced

Two subcategories of activities comprise IR 3.1 – prevention and technical assistance combined with direct services.

Prevention. The prevention of new HIV and TB infections is a priority of the South African national response across all governmental departments and all partners. USAID/SA through PEPFAR funding has been a critical ally and advocate of this multi-sectoral, multi-faceted approach since 2004, supporting a range of evidence-based biomedical, social, and structural interventions in various government departments driving the prevention agenda (Health, Basic Education, Defense, Public Service and Administration, Social Development, National Prosecuting Authority, and Women, Children and People with Disabilities) as well as with various NGOs. Continued USAID/SA engagement is required to support

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GoSA efforts in the strengthening of the national prevention response, to promote its integration into provincial plans, and to expand coverage of quality combination HIV prevention interventions, with particular attention to innovative and proven models targeting key populations. The USG’s prevention strategic focus will be to:

a. Align its activities with the NSP and integrate them into provincial plans; b. Support GoSA’s combination prevention strategy focusing on particular key populations; c. Identify capacity and service delivery gaps for prioritizing USG support under PEPFAR funding; d. Consolidate the portfolio for greater epidemiologic, demographic, and geographic efficiency and impact; and e. Participate in cross-sectoral, multi-partner prevention planning, coordination, and implementation efforts.

Technical assistance to key government and non-governmental actors providing direct service delivery in 35 selected areas, and direct services to prevent new infections while host systems are strengthened. The programmatic activities in support of the NSP may include:

TB and HIV counseling and testing (HCT) especially for key populations Prevention of gender-based violence (GBV) Integrated gender equity and HIV prevention in school-based curricula, including male and

female condom promotion, family planning, and use of multi-media communication channels Prevention of mother to child transmission (PMTCT) Voluntary medical male circumcision (VMMC) Comprehensive prevention interventions for people living with HIV and those affected by it Technical assistance to improve the systems and programs of Departments driving the prevention

agenda; Strengthening data management and use for prevention, including improvement of monitoring

and evaluation of prevention interventions Community-based demand creation and social norm and behavior change interventions Strengthen community systems to address HIV prevention and social and gender norms,

including both proven interventions and innovation in program implementation. Joint support for innovative approaches, with potential for high impact in the future Capacity building in supply chain management of key prevention commodities (e.g., condoms,

test kits, Medical Male Circumcision (MMC) kits, TB drugs) Support for intensified TB/HIV case finding and infection control in priority TB districts Support to GoSA efforts for developing policies and tools such as point-of-care technology to

improve prevention linkages to care and treatment services; and

Intermediate Result 3.2: Increased sustainability of effective HIV & TB response systems

Heath Service Strengthening. As the USAID/SA program transitions away from direct service provision, the focus will be on strengthening the health systems capacity at provincial and district level following the WHO six building blocks for health systems. USAID/SA plans to focus on strengthening leadership and governance within government structures, improving human resources for health and social development, strengthening the supply chain (i.e., drug procurement, condom procurement, MMC kits), improved cost effectiveness of programs through budget planning and financial management at the district and provincial levels (including mobilization of local resources), an improved use of strategic information, and strengthening of community linkages and mobilization.

Activities to support to GoSA efforts include: Strengthened governance at district and sub-district level via training and mentoring. In

particular, developing leadership skills to coordinate, manage, implement, and monitor, and at the same time scale up these programs.

Integrating internationally recognized leadership and management courses into local universities targeting leadership and management gaps in the Department of Health

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Multi-sectoral pre-service training activities, as well as in-service training, and mentoring support. This support will include social workers and other community workers district and provincial management staff of the relevant government departments.

Capacity building in supply chain management for pharmaceuticals and commodities from the facility to the district and provincial levels to ensure continuous supply of medicines such as anti-retrovirals (ARVs), opportunistic infections medicines, TB prophylaxis and treatment, and commodities such as condoms and test kits. Health financing

Improving the collection, use and availability of strategic information to inform policy development, program implementation and management at the provincial and district levels via a national research agenda to inform service delivery models.

Support the DSD’s information system that provides information about OVC service delivery and community-based care.

Support in areas of research, innovation, surveillance, and program evaluations to improve health service delivery and health outcomes including HIV and TB outcomes and prevent new infections.

Community Systems Strengthening (CSS) to address the spread of HIV and TB as it is at the community level, including social, cultural, structural and gender norms that underpin the epidemic. Build capacity of community structures and leadership to coordinate with relevant GoSA departments to improve and sustain the HIV/TB response by actively linking the community to HIV/TB services.

Intermediate Result 3.3: Improved care & treatment of vulnerable populations Four sub-categories of activities comprise IR 3.3; these categories are Care and Treatment, TB and MDR-TB, and Orphans and Vulnerable Children, Gender-Based Violence. The activities included in these subcategories are summarized below.

Care and Treatment. Over the past five years GoSA has made unprecedented efforts in rapidly establishing an HIV care and treatment program which is larger than any other in the world, with an estimated 1.7 million people on anti-retroviral therapy (ART) in 2012. USG funding has been critical in the scale-up of this program over the years; approximately 50 percent of PEPFAR funding has gone towards support for HIV and TB care and treatment services.

Currently, USG support in the public sector seeks to increase access to ART throughout South Africa. USAID/SA is supporting the GoSA implementation of PHC re-engineering to increase the number and capacity of public health workers.

Activities in this category may include: Strengthening the patient cascade from testing to treatment to care, improving the patient’s

experience, and ensuring immediate and continued follow up, including GBV survivors, OVCs, and people who test positive .

Psycho-social services for HIV infected and HIV affected people Strengthening service delivery platforms, especially in the public sector. Scaling-up treatment to reach the target set in the NSP (initiate 80 percent of eligible people on

ART) Health system strengthening to drive efficiencies in implementation of the national response.

e.g., Integration of HIV services, referral systems, training, mentorship, supervision, quality

improvement, health planning/budgeting, human resource management, supply chain management, information management, and monitoring and evaluation.

Assist patients with transfer from general practitioners (GP) and non-public sector sites to public sector facilities

Tuberculosis (TB) and Multi-Drug Resistant Tuberculosis (MDR – TB)

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Orphans and Vulnerable Children Primary prevention for HIV Care, support and protection: physically, psychologically, materially, socially, morally,

spiritually, and legally Child protection, clinical nutritional support General healthcare referral Health care support for access to antiretroviral treatment HIV prevention education, psychological care, educational support, and household economic

strengthening

Community Strengthening and Response Community-led behavioral change best practices identified and scaled up, including activities to

prevent HIV infection for children under 18 years resources to communities for self-identified/designed HIV and TB responses and to address

sexual violence and unequal gender relations Mobilize and strengthen community-based responses for the care, support, and protection of

OVC and youth. Support to improve access to reliable data and research on social effects of HIV and AIDS on

OVC. Support for strengthened coordination, management, and oversight of local structures, integration

and coordination across structures to build a supportive multi-sector environment, including social welfare system coordination, management of social welfare workforce.

Gender- based Violence (GBV) Support for Gender Based Violence programs of the GoSA, including improvement of law

enforcement and prosecution of GBV, and civil society groups in programs that focus on the prevention of gender-based violenceGBV awareness-raising

Provision of a range of essential services to rape survivors including emergency medical care, post-exposure prophylaxis (PEP), counseling and testing for HIV, psychosocial counseling and court preparation, in an integrated and victim-friendly manner

As set out in section 1.3, for the purpose of environmental review, the illustrative current and anticipated activities described under the USAID/South Africa Health three IRs above, are grouped into the following nine (9) intervention categories:

1. Health Care Waste Management (HCWM) 2. Procurement, storage, management, distribution and disposal of public health commodities &

equipment; strengthening public health commodity supply chain management.3. Construction4. Water and Sanitation for Health (WASH)5. Capacity Development/Training6. Social marketing, Education and Behavioral Change Communication (BCC)7. Policy & strategy development (including formulation of clinical norms) 8. Health Systems Strengthening: studies, surveys/public health surveillance and other data-

gathering assessments, models, and capacity-building in support of all areas above. Dissemination of resulting information/lessons learned/best practices

9. Umbrella Grant Mechanisms in support of Development Objective 3: Improved health outcomes for South Africans

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Individual projects4 in many instances carry out activities in more than one sub-sector, and the projects are designed to be mutually supportive and synergistic so that the portfolio overall embodies an integrated approach.

Each category contains a number of entailed activities. In sections 3.4-3.10, the entailed activities are described and their potential impacts analyzed. On this basis, Recommended Determinations are made. In many cases, Negative Determinations entail conditions. Upon approval of this IEE, implementation of these conditions becomes mandatory.

3.2 CATEGORICAL EXCLUSIONS

A Categorical Exclusion is recommended for the activities listed below, because no environmental impacts are expected as a result of these activities. These fall under the following citations from Title 22 of the Code of Federal Regulations, Regulation 216 (22 CFR 216), subparagraph 2(c)(2) as classes of activities that do not require an initial environmental examination:

(i) Activities involving education, training, technical assistance or training programs except to the extent such programs include activities directly affecting the environment (such as construction of facilities, etc.);

(iii) Activities involving analyses, studies, academic or research workshops and meetings; (v) Activities involving document and information transfers; (viii) Programs involving nutrition, health care, or family planning services except to the extent

designed to include activities directly affecting the environment (such as construction of facilities, water supply systems, waste water treatment, etc.);

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

For specific intervention areas, Categorical Exclusions are recommended, per the above, for:

Prevention of Mother to Child Transmission (PMTCT) activities, except those that generate medical and biohazardous materials, including disposal of unused or expired pharmaceuticals;

Support for strengthened referral systems intended to enhance capacity of healthcare providers to identify and refer patients to the next level of specialized care. As this activity entails training for enhanced medical capacity to improve processes for treatment, it is not likely to generate adverse environmental impacts.

Clinical interventions, care or treatment, except those that involve human or animal trials or generate medical and biohazardous materials;

Psychosocial support programs Orphans and vulnerable children (OVC) support, that does not involve construction, water

and sanitation, or generation of medical and biohazardous materials ; System strengthening, except those that could entail facility repair/rehabilitation and

development of potable water supplies; Behavior change interventions (abstinence/faithfulness, etc.), information, education, and

communications (IEC), etc.; Social marketing (condoms, other prevention), except those that generate medical biohazard

waste;

4 See footnote 1 regarding use of the terms “projects” and “activities” throughout this IEE (see Sect. 1.1).

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Maternal and Child Health (MCH) and Reproductive Health programs, except those which support the provision of immunization and vaccination services.

While the above activities are categorically excluded from further environmental scrutiny, this IEE nevertheless recommends that environmental health and quality considerations be incorporated into all relevant steps along the health care continuum, as part of quality assurance and infection prevention approaches. To this end, the Health Program has an opportunity to include healthcare waste (HCW) management messages, and to provide for appropriate disposal facilities in home-based and community-based situations. Positive messages about personal and household hygiene, sanitation, and proper disposal of condoms and other potentially harmful materials should be delivered, as appropriate, along with standard health care messages, and these messages should be included in training, protocols, and guidelines, and the success of such messages should be monitored. Examples of opportunities are the training plans for healthcare clinic staff on VCT and PMTCT services, and assistance to Department of Health (DOH) to develop and implement guidelines for quality measures.

3.3 NEGATIVE DETERMINATIONS WITH CONDITIONS

A Negative Determination with Conditions is recommended, pursuant to 22 CFR216.3(a)(2)(iii), for Health Program activities that have potential for adverse impacts on the environment in the following categories. The Health Team will work with its implementing partners, to the extent possible, in the following areas, in accordance with the conditions and mitigation actions associated with the recommended Negative Determination5.

Where Negative Determinations with Conditions are identified, an Environmental Mitigation and Monitoring Plan (EMMP) for the conditions must be developed, budgeted and implemented by the Implementing Partner.

In the instance that specific subgrants or subcontracts are not fully defined for small-scale activities, a subsidiary environmental review is required as a condition of this IEE. The agreement or other document obligating funds may contain appropriate covenants or conditions precedent to disbursement for unidentified subprojects, or aspects of projects, programs, or activities. This typically includes a subsidiary environmental screening and review process which an environmental review form (ERF) and environmental review report (ERR). The subsidiary environmental review process and form are described at http://www.usaidgems.org/subsidiary.htm. This applies, for example, to the Umbrella Grants Mechanism (Sect. 3.3.9), inter alia. See Section 4.0 (and Annex 4) for the Sub-grants Environmental Screening process applicable to DO 3 IPs as appropriate.

3.3.1 HEALTH CARE WASTE MANAGEMENT Background: This is a general discussion and analysis of waste-related impacts of health care activities. It is referenced at several points in the analyses of the specific intervention categories that follow in sections 3.4—3.10.

Although healthcare activities provide many important benefits to communities, they can also unintentionally do harm via poor management of the wastes they generate. These wastes generally fall into three categories in terms of public health risk and recommended methods of disposal:

5 The ability of the Team to assure such procedures and capacity is understood to be limited by its level of control over the management of the facilities and operations that USAID/South Africa is supporting, as well as available funding.

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General healthcare waste, similar or identical to domestic waste, including materials such as packaging or unwanted paper. This waste is generally harmless and needs no special handling; 75–90% of waste generated by healthcare facilities falls into this category, and it can be burned or taken to the landfill without any additional treatment.

Hazardous healthcare wastes including infectious waste (except sharps and waste from patients with highly infectious diseases), small quantities of chemicals and pharmaceuticals, and non-recyclable pressurized containers. All blood and body fluids are potentially infectious.

Highly hazardous healthcare wastes, which should be given special attention, includes sharps (especially hypodermic needles), highly infectious non-sharp waste such as laboratory supplies, highly infectious physiological fluids, pathological and anatomical waste, stools from cholera patients, and sputum and blood of patients with highly infectious diseases such as TB and HIV. They also include large quantities of expired or unwanted pharmaceuticals and hazardous chemicals, as well as all radioactive or genotoxic wastes.

Pharmaceutical Wastes and Medical Supplies, including condoms: Pharmaceutical drugs including vaccines 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.

The effects of pharmaceutical waste in the environment are different from conventional pollutants. Drugs are designed to interact within the body at low concentrations to elicit specific biological effects in humans, and which may also cause biological responses in other organisms. There are many drug classes of concern, including antibiotics, antimicrobials, antidepressants, and estrogenic steroids. Their main pathway into the environment is through household use and excretion, and through the disposal of unused or expired pharmaceuticals.

Effects on aquatic life are a major concern in disposal of pharmaceuticals. A wide range of pharmaceuticals has been discovered in fresh and marine waters globally, and even in small quantities some of these compounds have the potential to cause harm to aquatic life.

Additional health risks related to disposal include burning pharmaceuticals and plastic medical supplies (including new or used condoms) at low temperatures or in open containers results in release of toxic pollutants into the air. Inefficient and insecure sorting and disposal may allow drugs beyond their expiry date to be diverted for resale to the general public.

Potentially infectious wastes: Improper training, handling, storage 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. Those who come in direct contact with the waste are at greatest risk. Examples include healthcare workers, cleaning staff, patients, visitors, waste collectors, disposal site staff, waste pickers, substance abusers and those who knowingly or unknowingly use “recycled” contaminated syringes and needles. Although sharps pose an inherent physical hazard of cuts and punctures, the much greater threat comes from sharps that are also infectious waste. Healthcare workers, waste handlers, waste-pickers, substance abusers and others who handle sharps have become infected with HIV and/or hepatitis B and C viruses through pricks or reuse of syringes/needles.

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

Mandatory Health Care Waste Management (HCWM) Procedures and Guidelines

GoSA mandatory procedures and guidance are outlined in Annex 1: GoSA Procedures and Guidance for Disposal and Treatment Methods Suitable for Different Categories of Health Care Waste. These are to be reviewed with care by USAID staff and applied by IPs for their own activities, where applicable. IPs are also required to take an active role in helping ensure that other GoSA partners and units are adhering to GoSA procedures and making use of the most current GoSA guidance, and the best practice guidance from local and global waste management professionals.

The Health Program and IPs shall ensure that all activities involving generation of medical and related hazardous materials waste comply with GoSA regulations covering this sector, as well as conditions/mitigation measures outlined in the table below. All USAID activities shall include appropriate procedures to reduce and dispose of waste materials properly. These mitigation measures are pro-active in nature and designed to further support South Africa’s application of its procedures.

Heath Care Waste Management

Activity Recommended Determination

The following are illustrative activities being implemented under the Health Program that need to ensure proper management and disposal of Heath Care Waste (HCW):

TB and HIV counseling and testing (HCT) especially for key populations

prevention of mother to child

transmission (PMTCT), if testing and drug storage and disposal are involved.

voluntary medical male circumcision (VMMC)

comprehensive prevention interventions for people living with HIV and those affected by it, family members and specifically orphans and vulnerable children

technical assistance to improve the systems and programs of Departments driving the prevention agenda; sexual prevention including male and female condom promotion and

Negative determination with the following conditions :

1. For Health Program-supported activities including blood testing, laboratory support and other support which may directly or indirectly result in generation of biohazardous health care waste, the team must work with its implementing partners to ensure, to the extent possible, that the medical facilities and operations involved have adequate procedures and capacities in place to properly handle, label, treat, store, transport and properly dispose of blood, sharps and other medical waste.

2. Ensure that a medical waste management program and clinical guidelines are developed and implemented for biohazardous waste at the relevant facilities supported by USAID per general conditions described in section 3.3.1.

3. Ensure that training and technical assistance in the management of HCW appropriate to the South African environment is provided where appropriate, and assistance is provided to develop disposal mechanisms that are cost effective and safe. Refer to the USAID Sector Environmental Guidelines for Healthcare Waste (see below).

4. Incorporate environmental health and quality considerations into all relevant steps along the health care continuum, as part of the quality assurance and infection prevention approaches.

5. At facilities receiving USAID support, encourage implementation of the South African Quality Assurance System, which inspects selected health facilities, to ensure that healthcare waste issues are properly dealt with. Capitalize upon the integration of the HCW management issue into the

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Activity Recommended Determination

use of multi-media communication channels

strengthen community systems to address HIV prevention and social and gender norms, including both proven interventions and innovation in program implementation.

joint support for innovative approaches, especially when support for innovative projects is expected to have a significant financial implication for the GoSA further down the line (e.g., pilot projects for ‘test and treat,’ or ‘treatment as prevention’)

capacity building in supply chain management of key prevention commodities (e.g., condoms, test kits, Medical Male Circumcision (MMC) kits, TB drugs)

support for GoSA efforts to integrate HIV prevention and family planning services

support for intensified TB/HIV case finding and infection control in priority TB districts

strengthening the patient cascade from testing to treatment to care, improving the patient’s experience, and ensuring immediate and continued follow up, where testing; capacity development and training in health care waste and pharmaceutical management and disposal are to be strengthened..

care for people who test positive, GBV survivors, and OVCs.

scaling-up treatment to reach the target set in the NSP (initiate 80 percent of eligible people on ART)

mainstreamed “access, demand, quality, and management” approach to USAID’s Quality Assurance health program delivery.

6. Make provision for the incorporation of standard practices and protocols for the safe handling and disposal of bio-hazardous materials, in consultation and coordination with Department of Health (DOH) and other partners.

7. Training/curricula/supervision must address appropriate management practices concerning the proper handling, use, and disposal of medical waste, including blood, sputum, and sharps, when techniques or care situations being addressed would generate and require disposal of hazardous or highly hazardous waste (e.g. sharps, afterbirth from delivery, waste from screening for HIV or STDs, sputum samples for diagnosis of TB).

Note that these conditions APPLY to activities targeting home care and community health workers: IPs must, as appropriate, include healthcare waste (HCW) management messages and develop appropriate disposal mechanisms in home-based and community-based situations that are cost effective and safe. Positive messages about personal and household hygiene, sanitation, and proper disposal of condoms and other potentially harmful materials should be delivered, as appropriate, along with standard health care messages, and these messages should be included in training, protocols, and guidelines.

Mandatory reference. The USAID Sector Environmental Guidelines for Healthcare Waste (http://www.usaidgems.org/Sectors/healthcareWaste.htm) contains guidance, which inform compliance with these conditions, particularly in the section titled, “Minimum elements of a complete waste management program.” See also WHO’s “Safe Management of Wastes from Healthcare Activities.”

Where the GoSA has primary responsibility for HCWM, the IP will nevertheless exercise a diligent Boundary of Responsibility(BoR) by ascertaining the effectiveness of those elements of Government’s HCWM system that handles and disposes of project generated wastes. Where these appear inadequate, deficiencies are to be identified with the GoSA and USAID and appropriate technical guidance provided as outlined in Annex 1 of this IEE.

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3.3.2 PROCUREMENT, STORAGE, MANAGEMENT, DISTRIBUTION AND DISPOSAL OF PUBLIC HEALTH COMMODITIES & EQUIPMENT;6 STRENGTHENING PUBLIC HEALTH COMMODITY SUPPLY CHAIN MANAGEMENT

Activities in this intervention category consist of support for provision of anti-retrovirals (ARVs); opportunistic infections medicines; TB prophylaxis and treatment drugs; drugs for the treatment of sexually-transmitted infections (STIs); condoms; HIV/AIDS and TB test kits; drugs for immunization and vaccinations.

Note that USAID direct control over commodities may end immediately after procurement, for commodities turned over to governmental entities. In other cases, USAID may directly fund and have control over the care delivery activity in which the commodities (e.g. pharmaceuticals) are used.

Potential Adverse Impacts & Considerations Regarding Recommended Determinations

Many procured commodities inevitably end up as waste (e.g. condoms, LLINs, laboratory chemicals, test kits), generate waste as a consequence of their use (e.g., injectable pharmaceuticals) or have the potential to end up as waste due to spoilage or expiration (i.e., all pharmaceuticals). Improper disposal of potentially infectious and pharmaceutical wastes has potentially significant adverse impacts, as discussed in section 3.3.1.

As noted above, the extent of USAID control in-country supply chain and use of these commodities ranges from complete to partial, depending on the programming context. To the greatest degree practicably permitted by this level of control, USAID must work to assure appropriate management of commodity waste streams.

Recommended Determinations

Based on the analysis presented in Section 3.3.1 regarding health care waste, this IEE recommends threshold decisions and conditions for implementation of USAID/SA’s Health Program activities. The environmental screening and review procedures described here do not substitute for the host country’s own environmental laws and policies.

A Negative Determination with conditions for supply chain strengthening activities with the following conditions:

Supply chain activities at all levels involving procurement, storage, management and/or disposal of public health commodities, including pharmaceutical drugs, immunizations and nutritional supplements, must ensure, to the greatest extent practicable, that the medical facilities and operations involved have adequate procedures and capacities in place to properly manage and dispose of expired, obsolete, or surplus commodities.

Consignees for any pharmaceutical drugs procured under this funding will be advised to store the product according to the information provided on the manufacturer’s Materials Safety Data Sheet (MSDS).

If disposal of any of these pharmaceutical drugs is required, due to expiration date or any other reason, the consignee will be advised that the preferred method of disposal is to return to the manufacturer. If this is not possible then follow WHO guidelines for Safe Disposal of Unwanted Pharmaceuticals.

6 As used herein, “public health commodities” may include pharmaceutical drugs and vaccines, condoms, laboratory and medical supplies, basic medical equipment and personal protective gear.

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Disposal of packaging and other public health commodities will be treated using the guidelines provided in USAID Solid Waste Sector Environmental Guideline (http://www.usaidgems.org/Sectors/solidWaste.htm)

Procurement management & disposal of public health commodities & equipmentStrengthening public health commodity supply chain management

Activity Recommended Determination

Supply chain management of key prevention and care & treatment commodities to ensure continuous supply for medicines, including but not limited to::

anti-retrovirals (ARVs) opportunistic infections

medicines TB prophylaxis and

treatment drugs drugs for the treatment of

sexually-transmitted infections (STIs)

Condoms HIV/AIDS and TB test kits drugs for immunization and

vaccinations. Capacity building in supply

chain management for pharmaceuticals and commodities from the facility to the district and provincial levels to ensure continuous supply of medicines such as anti-retrovirals (ARVs), opportunistic infections medicines, TB prophylaxis and treatment, and commodities such as condoms and test kits

A Negative Determination with conditions is recommended for procurement management & disposal of public health commodities & equipment. And strengthening public health commodity supply chain management. Conditions are as follows::

1. Supply chain strengthening activities at all levels must address and take all practicable efforts to assure that adequate facilities, procedures and capacities are in place to properly manage expired, obsolete or surplus commodities.

2. Consignees for any pharmaceutical drugs procured under this funding will be advised to store the product according to the information provided on the manufacturer’s Materials Safety Data Sheet (MSDS). These are supplied by the manufacturer, and can also be found on the internet by using the active ingredient and MSDS as search terms.

3. Disposal of packaging and other public health commodities, including those that become hazardous or highly hazardous, will be treated using the guidelines provided in USAID Solid Waste Sector Environmental Guideline (http://www.usaidgems.org/Sectors/solidWaste.htm) and WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies, (www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf)

4. Implementing partners will work with the South African National Department of Health on all aspects of essential medicine supply chain management, including estimating demand, distribution, and storage issues of time and temperature. .

Mandatory references: USAID Solid Waste Sector Environmental Guideline (http://www.usaidgems.org/Sectors/solidWaste.htm) and WHO Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies, (www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf

3.3.3 SMALL-SCALE CONSTRUCTION

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The activities entailed in this category include refurbishment of clinics, establishment of park homes, and/or regional training centers to support health improvements and may cause adverse impacts on the environment, including the following:

Impacts of the construction process

Construction itself has a well-known set of potential adverse impacts, including the following:

Disturbance to existing landscape/habitat. Construction typically necessitates clearing, grading, trenching and other activities that can result in near-complete 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 result in sedimentation/fouling of surface waters, particularly if the site is located in close proximity to a stream or waterbody.

Standing water. Construction may result in standing water on-site, which readily becomes breeding habitat for mosquitoes and other disease vectors.

Experience shows that these impacts are controllable below the level of significance with basic good construction management practices.

Adverse impacts of materials sourcing. Construction requires a set of materials often procured locally: timber, fill, sand and gravel, bricks. Unmanaged extraction of these materials can have adverse effects on the environment. For example, streambed mining of sand or gravel can increase sedimentation and disturb sensitive ecosystems and purchase of timber from unmanaged or illegal concessions helps drive deforestation.

While IPs generally have direct control over their 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 IPs can take to assure environmentally responsible sourcing of these materials and reduces IP responsibility for these impacts. (It should also be noted that for the relatively small construction projects anticipated under the FHP portfolio, adverse impacts related to materials sourcing should be quite limited.

However, IPs can and should undertake reasonable due diligence to assure that they do not bear direct responsibility for adverse impacts, and to reduce indirect impacts so far as feasible.

In the absence of complicating factors,7 USAID AFR Bureau has concluded that very small-scale general construction involving a total “disturbed area” of less than 1000m2 is of its nature very unlikely to create significant adverse impacts. Construction at larger scales (or very small-scale construction in the presence of complicating factors) does present the risks that the impacts described above could be significant.

Impacts of facilities in operation: In operation, general/institutional facilities & 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.

7 Complicating factors include, e.g. siting within 30m of a permanent or seasonal stream or water body, or displacement of existing settlement/inhabitants, or building on an average slope in excess of 5%, or building on a site that is heavily forested or in an otherwise undisturbed local ecosystem.

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For example, failure to design or maintain appropriate drainage structures can result in standing water within the compound or on adjacent land. Local erosion, including damage to adjacent fields, and sedimentation of nearby surface waters 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 insects, birds, rodents and waste pickers.

For health care facilities, the above risks are heightened due to (1) the higher likelihood that infectious diseases that may be present in human excreta, (2) the vulnerability of patient populations to poor environmental health conditions, and (3) the particular hazards of health care waste, as described in Section 3.1. Failure to provide infrastructure for appropriate management of health care waste in facility construction/rehabilitation and failure to observe appropriate design standards for sanitation provision can have significant adverse consequences.

In general, the potential impacts of facilities construction and operation smaller than 1000m2 are controllable with basic good design and operating practices. However, the precise nature of the potential impacts, and the appropriate design and operating practices to mitigate them, are highly dependent both on location and the specific characteristics of the infrastructure. Not enough information is known regarding DO3’s construction at this scale to assess these impacts.

Small- scale Construction and Renovation Activities

Activity Recommended Determination

The following are illustrative activities under the Health Program that need to ensure that adverse environmental effects do not occur:

Small-scale construction/rehabilitation at clinical/treatment sites in association with TB, VCT, PMTCT, ANC and other PHC services;

Installation of park homes for provision of TB, VCT, PMTCT, ANC and other PHC services;

Support for construction of Regional Training Centers that train health care professionals in AIDS services;

Support for construction or rehabilitation of facilities associated with community-based OVC projects.

Negative determination with the following conditions :

All construction activities will be conducted following principles for environmentally sound construction, as provided in Small Scale Construction chapter of the USAID Sector Environmental Guidelines (http://www.usaidgems.org/sectorGuidelines.htm ). At minimum, 1) During construction, prevent heavy run-off of sediment, by covering sand/dirt piles, or by choice of location; 2) Construction must be managed so that no standing water on the site persists for more than 4 days; 3) IPs must require their general contractor to certify that it is not extracting fill, sand, or gravel from waterways or ecologically sensitive areas, nor is it knowingly purchasing these materials from vendors who do so; 4) IPs must identify and implement any feasible measures to increase the probability that timber is procured from legal, well-managed sources.

1. For the rehabilitation of existing facilities, and for construction of facilities in which the total surface area disturbed is less than 10,000 square feet ( below 1000 square meters), the Condition is that these activities will be conducted following principles for environmentally sound construction, as provided in the Small Scale Construction chapter of the USAID Environmental Guidelines.

2. For the construction of any facilities in which the total surface area disturbed exceeds 10,000 square feet (about 1,000 square meters), the

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Activity Recommended Determination

program will use a Subsidiary Review process by applying an Environmental Review Form (ERF) and preparing an Environmental Review Report (ERR) as found on the GEMS website at http://www.usaidgems.org/subsidiary.htm. Construction may not begin until such a review is completed and approved by the Mission Environmental Advisor or the REA, as necessary.

3. Majority of materials used will be of local origin and will not contain any hazardous materials (e.g., asbestos or lead). Some of the buildings to be renovated may contain asbestos or related products; therefore, we recommend that the building be tested for the presence of asbestos-based compounds before the rehabilitation works began. Should asbestos be present in the facilities to be renovated, then the contractor(s) shall ensure that proper South African regulations to dealing with asbestos removal are implemented to ensure workers safety during the rehabilitation works. Results of the testing for asbestos shall be communicated to the C/AOR .

4. Excess construction material will be recycled wherever possible and disposal of unusable material will be done in an environmentally-sound manner;

5. No lead-based paint shall be used, when lead-free paint is used, it 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. No pesticides will be used without amendment of this IEE to include a pesticide analysis per 22 CFR 216.3(b)(1);

7. Where water supplies for drinking or washing patients or laundry are upgraded or provided, measures will be taken to ensure that drainage from laundry and bathing facilities does not affect the water supply nor pose threats for transmittal of infectious diseases;

8. Provision of potable water supplies and/or latrines will follow the Republic of South Africa or WHO standards concerning the appropriate separation of wells and latrines and measures to avoid contamination of water sources.

3.3.4 WATER AND SANITATION FOR HEALTH (WASH)The WASH program currently includes one activity, a public- private partnership with Coca Cola, scheduled to end in 2014.

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WASH Related to Healthcare Wastes

Where health care wastes are associated with projects and activities, special care must be exercised in handling and disposing of infected patients, including human waste and effluents and greywater from bathing, facility cleaning of toilets/latrines floors and equipment, bathing areas, clothes washing, etc.

Public Private Partnership (PPP): Integrating Water and Sanitation into HIV/AIDS Programs, Nutrition

The Health Program has only one award directly related to WASH for Health. This $37.1 million (estimated) activity is new, but scheduled to end in September 2014. It will be a continuation of the work done under the Water and Development Alliance (WADA), which is a public/private partnership (PPP) between USAID and Coca Cola Company. It addresses management of water, sanitation, and hygiene (WASH) issues at health facilities, schools and in communities to improve the quality of life of PLWH and their families. The program will include water, sanitation, and hygiene (WASH) counseling and support within NACS, including counseling on safe food preparation and storage and point-of-use water purification treatment. The program will strengthen and incorporate projects that will target rehabilitation of toilets in schools, increase the number of taps in schools, increase elbow taps and sanitation dispensers in municipal clinics, and increase the number of communal water points in informal settlements. WASH is a preventive health measure for PLWH, their caregivers, health workers, and others. By supplementing existing HIV programs with WASH interventions; the program will continue to form collaborations, aligning corporate social investment with municipal water infrastructure delivery priorities.

Per the analysis above, the following threshold determinations are recommended:

Both the general WASH activities associated with Healthcare Waste management and the USAID/Coca Cola are recommended for Negative Determination with Conditions.

Conditions:

1. IPs will apply the USAID Environmental Guidelines for Small Scale Activities guidance for water and sanitation found at http://www.usaidgems.org/Sectors/watsan.htm

2. A/CORs will ensure development and oversight of WASH activities through IP EMMP development, implementation and reporting as part of quarterly or semi-annual project progress reports and workplan reviews.

3. Standard GDA conditions apply for the partnership project with Coca Cola. GDA guidance can be found in the Environmental Compliance for Global Development Alliance Activities at http://www.usaidgems.org/complianceTopics.htm

3.3.5 CAPACITY DEVELOPMENT/TRAININGThis intervention category encompasses capacity development and training in prevention, care and treatment for HIV/AIDS, TB and MDR-TB; MCC; PMTCT, OVC and GBV.

All activities in this intervention category are intended to improve and expand the delivery of and/or access to health care services. As detailed in Section 3.3.1, the delivery of these services presents a set of potentially significant adverse environmental impacts, particularly related to medical waste. Expansion of these services while strengthening delivery and/or access to health care services may generate environmental effects.

Where USAID support for service delivery is direct, USAID bears full responsibility for unnecessary and potentially significant adverse impacts when its support fails to address health care waste management or to consider the capacity of medical facilities to properly handle, label, treat, store, transport and properly dispose of medical waste.

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Where USAID instead funds capacity building for the entities that manage delivery of care (e.g. government ministries), USAID is likely to have less control over service delivery on the ground. Reduced control means that USAID’s responsibility for adverse impacts is shared or attenuated—but not eliminated.

For example, proper health care waste management (HCWM) requires that the systems and structures governing health care delivery address and require appropriate management. Where USAID’s support means that USAID has substantial influence over these systems and structures, USAID and IPs must work to best assure that these systems and structures support appropriate HCWM.

Note: Small rehab of facilities associated with training is covered under the construction section (Section 3.3.3) and subject to the relevant conditions described therein. Potential Adverse Impacts & Considerations Regarding Recommended DeterminationsTraining is one of a class of activities under 22 CFR 216 eligible for categorical exclusion. However, capacity development/training of health care providers in HIV/AIDS and TB prevention, health systems strengthening (HSS) and care and treatment is intended to improve and expand the delivery of and/or access to health care services. As detailed in Section 3.1 Summary of Health Program Activities by Intermediate Results, the delivery of these services presents a set of potentially significant adverse environmental impacts, particularly waste-related.

Further, the purpose of the training activities and the development of training curricula are to influence the actions of healthcare providers/service delivery agents. Leadership development at the District and Regional levels will likely influence the actions of healthcare providers and service delivery agents. Appropriate management of health care waste depends heavily on individual actions of these agents: e.g., is there consistent separation of sharps and “red bag” waste? Training therefore must, as appropriate, address proper handling, use and disposal of health care waste, including proper disposal of blood, sputum, swabs, masks and sharps associated with HIV/AIDs and TB and MDR-TB testing. Such training should extend to correct water and sanitation practices including maintenance of latrines, toilet and bathing systems, disinfection and disposal of grey water from washing of bedding, clothing, floors, and containers. The maintenance of health clinic grounds, waste disposal areas and incinerators are continuing issues.

Finally, training in the storage handling and disposal of expired or damaged pharmaceuticals is an important component of capacity development and training.

Recommended Determinations

Per the analysis above, the following threshold determinations are recommended:

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Capacity Development/Training: Prevention, Care and Treatment HIV/AIDS, TB and MDR-TB; MCC; PMTCT, OVC and GBV

Activity Recommended Determination

The following are illustrative activities under the Health Program that need to ensure that adverse environmental effects do not occur: Support for multi-sectoral

pre-service training activities, in-service training and mentoring support in the Department of Health

Support to strengthen management of social welfare workforce.

Support (direct or indirect) for blood testing, screening or treatment for HIV, STIs, and TB which may occur as part of Voluntary Counseling and Testing (VCT), Antenatal Care (ANC), STIs, or Prevention of Mother-to-Child Transmission (PMTCT) programs;

VCT and PMTCT services at clinical/treatment sites

VCT and PMTCT at PHC and Antenatal Clinic (ANC) clients

STI screening, prevention, and treatment services

Sputum transfer programs that aim to facilitate an accurate TB diagnostic process.

Support for Regional Training Centers that train health care professionals in AIDS services

TB screening conducted as part of VCT, PMTCT, and ANC activities

Clinical interventions or treatment that may entail indirectly the testing of human or animal subjects;

Laboratory support which may directly or indirectly result in generation and

Negative determination with the following conditions :

Training/curricula/supervision must address appropriate management practices concerning the proper handling, use, and disposal of medical waste, including proper disposal of blood, sputum, swabs, masks and sharps associated with HIV/AIDs and TB and MDR-TB testing. Such training should extend to correct water and sanitation practices including maintenance of latrines, toilet and bathing systems, disinfection and disposal of grey water from washing of bedding, clothing, floors, and containers. Capacity development should also encompass the maintenance of health clinic grounds, waste disposal areas and incinerators are also continuing issues requiring attention.

Where the GoSA has primary responsibility for HCWM, the IP will nevertheless exercise a diligent boundary of responsibility (BoR) by ascertaining the effectiveness of those elements of Government’s HCWM system that handles and disposes of project generated wastes. Where these appear inadequate, deficiencies are to be identified with the GoSA and USAID and appropriate technical guidance provided as outlined in Annex 1 of this IEE.

Note that this condition APPLIES to activities targeting home care and community health workers: IPs must, as appropriate, include healthcare waste (HCW) management messages and develop appropriate disposal mechanisms in home-based and community-based situations that are cost effective and safe. Positive messages about personal and household hygiene, sanitation, and proper disposal of condoms and other potentially harmful materials should be delivered, as appropriate, along with standard health care messages, and these messages should be included in training, protocols, and guidelines.

1. Training/curricula/supervision must address appropriate management practices concerning the proper handling, use, and disposal of medical waste, including blood, sputum, and sharps, when techniques or care situations being addressed would generate and require disposal of hazardous or highly hazardous waste (e.g., sharps, afterbirth from delivery, waste from screening for HIV or STDs, sputum samples for diagnosis of TB).

2. IPs must, as appropriate, include healthcare waste (HCW) management plans and messages and develop appropriate disposal mechanisms that are cost effective and safe. Positive messages about personal and household hygiene, sanitation, and proper disposal of condoms and other potentially harmful materials should be delivered, as appropriate, along with standard health care messages, and these messages should be included in training, protocols, and guidelines. Note that this condition applies to activities targeting community health and home care workers.

3. Healthcare waste management plans should be implementedat the relevant facilities supported by USAID per the USAID Sector Environmental Guidelines for Healthcare Waste: (http://www.usaidgems.org/Sectors/healthcareWaste.htm) and WHO’s “Safe Management of Wastes from Healthcare Activities.”For Health Program-supported activities including blood testing, http://www.who.int/water_sanitation_health/medicalwaste/wastemana

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Activity Recommended Determination

disposal of bio-hazardous health-care waste;

TB screening and treatment (Directly Observed Therapy, Short Course—DOTS strategy)

Support for community-based home visiting and HBC, including palliative care, implemented through sub-grants to multiple community based organizations (CBOs)

Expanded Program on Immunization (EPI) and Integrated Management of Childhood Illness (IMCI) interventions

Other immunization and vaccination services which directly or indirectly result in generation and disposal of bio-hazardous health-care waste.

g/en/.

4. See GoSA procedures and guidance in Annex 1:

5. Ensure precautions are taken for prevention of transmission of HIV, hepatitis B virus, and other blood-borne pathogens in health-care settings.

6. Ensure that training and technical assistance in the management of HCW appropriate to the South African environment is provided where appropriate, and assistance is provided to develop disposal mechanisms that are cost effective and safe. Refer to the Africa Bureau’s Environmental Guidelines for Small Scale Activities in Africa (see above).

7. At facilities receiving USAID support, encourage implementation of the South African Quality Assurance System, which inspects selected health facilities, to ensure that healthcare waste issues are properly dealt with. Capitalize upon the integration of the HCW management issue into the mainstreamed “access, demand, quality, and management” approach to USAID’s Quality Assurance health program delivery.

The Government of South Africa (GoSA) has medical waste disposal regulations, which are described in Annex 1 of this IEE. The Health Program shall ensure that all activities involving generation of medical and related hazardous materials waste comply with South African regulations covering this sector, as well as mitigation measures outlined below. All USAID activities shall include appropriate procedures to reduce and dispose of waste materials properly. These mitigation measures are pro-active in nature and designed to further support South Africa’s application of its procedures.

Mandatory reference. The USAID Sector Environmental Guidelines for Healthcare Waste (http://www.usaidgems.org/Sectors/healthcareWaste.htm) contains guidance, which must inform compliance with these conditions, particularly in the section titled, “Minimum elements of a complete waste management program.” See also WHO’s “Safe Management of Wastes from Healthcare Activities.”

3.3.6 SOCIAL MARKETING, EDUCATION AND BEHAVIORAL CHANGE COMMUNICATION (BCC)This intervention category consists of social marketing, education/outreach and behavioral change communication activities are focused on the following:

GBV Gender equity and HIV prevention Best practices related to HIV and TB response, sexual violence, gender equity

A variety of media/mechanisms and distribution channels will be used, including but not limited to print, radio, schools, traditional authorities, and clinical workers.

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Potential Adverse Impacts & Considerations Regarding a Recommended Determination

Public awareness, education, and related social marketing initiatives are essential complements to activities that strengthen and expand care delivery systems and the healthcare workforce.

In many cases, these initiatives promote use of commodities such as condoms, drugs, and insecticide-treated nets. Improper disposal of these items by end-users (the targets of the marketing message) has adverse environmental impacts; see discussion under 3.3.1 above. However, the use and subsequent disposal stimulated by these programs is geographically dispersed, reducing the intensity of the impact, and USAID/IPs have very limited control over end-user actions. Additionally, it is expected that the health team will include messages that emphasize the proper storage, use, and disposal of these products. Taken together, these factors suggest that the categorical exclusion to which communication/education/outreach activities normally qualify is also applicable in this case.

Note, however, that this categorical exclusion does NOT necessarily apply to the distribution of these commodities.

Recommended Determinations:

Social Marketing, Education/outreach and Behavioral Change Communication

Activity Recommended Determination

Prevention of gender-based violence (GBV)

Integrate gender equity and HIV prevention in school-based curricula

Sexual prevention through multi-media communication channels, including male and female condom promotion and use

Behavior change communication best practices- HIV and TB responses, sexual violence, unequal gender relations, and mobilization of community-based responses for care, support & protection of OVC and youth

Social & individual BCC activities to prevent HIV infection for children under 18 years of age

Negative determination with the following conditions :

1. Training/curricula/supervision must address appropriate management practices concerning the proper handling, use, and disposal of medical waste, including blood, sputum, and sharps, when techniques or care situations being addressed would generate and require disposal of hazardous or highly hazardous waste (e.g. sharps, afterbirth from delivery, waste from screening for HIV or STDs, sputum samples for diagnosis of TB).

2. Note that this condition APPLIES to activities targeting home care and community health workers: IPs must, as appropriate, include healthcare waste (HCW) management messages and develop appropriate disposal mechanisms in home-based and community-based situations that are cost effective and safe. Positive messages about personal and household hygiene, sanitation, and proper disposal of condoms and other potentially harmful materials should be delivered, as appropriate, along with standard health care messages, and these messages should be included in training, protocols, and guidelines.

Mandatory reference. The USAID Sector Environmental Guidelines for Healthcare Waste (http://www.usaidgems.org/Sectors/healthcareWaste.htm) contains guidance, which must inform compliance with these conditions, particularly in the section titled, “Minimum elements of a complete waste management program.” See also WHO’s “Safe Management of Wastes from Healthcare Activities.”

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------------------------------------------------

3.3.7 POLICY & STRATEGY DEVELOPMENT (INCLUDING FORMULATION OF CLINICAL NORMS)Activities in this intervention category consist of the following:

Policies and tools for improved health care delivery Strengthening leadership and governance Support to GoSA and civil society groups for prevention of gender-based violence, improvement of law

enforcement and prosecution of GBV, and provision of essential services to rape survivors

Potential Adverse Impacts & Considerations Regarding Recommended Determinations

The activities in this category are intended to strengthen South Africa’s system of health services and related policies, in particular, efforts will focus on minimizing duplication among health services actors and on improving guidance and aligning policies, both internally and with international standards, within the health sector. As such, this group of activities is not likely to produce adverse environmental impacts.

Recommended Determinations

For activities associated with Section 3.7, Policy and Strategy Development and Assistance, a Categorical Exclusion is recommended per 22 CFR 216.2(c)(2)(xiv) Studies, projects, or programs intended to develop the capability of recipient countries to engage in development planning.

Policy & Strategy Development (including formulation of clinical norms)

Activity Recommended Determination

Support to GoSA, at multiple levels, including:

Develop policies and tools, such as point-of-care technology to improve prevention linkages to care and treatment services

Strengthen leadership and governance within government structures, including coordination, management, implementation and monitoring

Improve cost effectiveness of programs through budget planning and financial management at the district and provincial levels, with particular focus on management of HIV conditional grants

Improve resources for health and social development

Support to GoSA and civil society groups that have programs focused on prevention of gender-based violence, improvement of law enforcement and prosecution of GBV, and provision of essential services to rape survivors, including emergency medical care, post-exposure

Categorical Exclusion per CFR 216.2 (c)(2)(xiv) Studies, projects, or programs intended to develop the capability of recipient countries to engage in development planning, except where activities generate and require disposal of hazardous or highly hazardous waste (e.g., sharps, afterbirth, waste from screening for HIV or STDs, sputum samples).

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prophylaxis (PEP), counseling and testing for HIV, psychosocial counseling and court preparation

------------------------------------

3.3.8 HEALTH SYSTEMS STRENGTHENING:

Studies, Surveys/Public Health Surveillance & Other Data-Gathering Assessments, Models, & Capacity-Building in Support of All Areas Above. Dissemination of Resulting Information/Lessons Learned/Best Practices

Activities in this intervention category may include but are not limited to: Data collection, management, and dissemination Strengthening of governance at multiple levels Community systems strengtheningNote: this intervention category does NOT include human drug trials or tests or experiments to ascertain the efficacy of vector control or health interventions.

Potential Adverse Impacts & Considerations Regarding Recommended Determinations

No significant adverse impacts, whether direct or indirect are foreseeable from this intervention category, except for activities involving the collection and/or analysis of blood or body fluid samples or other activities that may generate medical waste. This includes, e.g., tuberculosis surveillance, which involves collection and transportation of sputum samples.

Recommended Determinations

A Categorical Exclusion for activities EXCEPT those involving the collection and/or analysis of blood or body fluid samples (per 22 CFR 216.2 (c)(viii) programs involving nutrition, health care, or population and family planning services).

A Negative Determination with conditions for activities in this category that DO involve the collection and/or analysis of blood or body fluid samples. The condition is as follows:

Epidemiological surveillance supported with USAID funds and involving the collection and/or analysis of blood or body fluid samples must have adequate procedures and capacities in place to properly handle, label, treat, store, transport and properly dispose of blood, body fluids, sharps and other medical waste generated by these activities.

Note: If transport of TB samples is contemplated, this will require a separate determination.

Health Systems Strengthening

Activity Recommended Determination

The following are illustrative activities under the Health Program that need to ensure that adverse environmental effects do not occur: Strengthened governance at district and sub-district level

A Categorical Exclusion for all activities EXCEPT those involving the collection and/or analysis of blood or body fluid samples (per 22 CFR 216.2 (c)(viii) programs involving nutrition,

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Activity Recommended Determination

and in particular developing leadership skills to coordinate, manage, implement, and monitor, and at the same time scale up these programs.

Integrate leadership and management courses into local universities to address leadership and management gaps in the Department of Health

Multi-sectoral pre-service training activities, as well as in-service training, and mentoring support, including social workers and other community workers, and district and provincial management staff of the relevant government departments.

. Improving the availability and use of strategic information

to inform policy development and program implementation, including collection and use of data for program management, OVC service delivery, and community-based care.

Health Service Delivery Innovation to identify best practices and achieve new efficiencies in the HIV and TB response, including a national research agenda

Support in areas of research, innovation, surveillance, and program evaluations to improve health outcomes including HIV and TB outcomes and prevent new infections.

Community Systems Strengthening (CSS) to address the spread of HIV and TB .to improve and sustain the HIV/TB response by actively linking the community to HIV/TB services.

CSS to addressing social, cultural, structural and gender norms that underpin the epidemic.

health care, or population and family planning services).

A Negative Determination with conditions for activities in this category that DO involve the collection and/or analysis of blood or body fluid samples. The condition is as follows:

Epidemiological surveillance supported with USAID funds and involving the collection and/or analysis of blood or body fluid samples must have adequate procedures and capacities in place to properly handle, label, treat, store, transport and properly dispose of blood, body fluids, sharps and other medical waste generated by these activities.

Note: If transport of TB samples is contemplated, this will require a separate determination.

(4) Negative Determination with the following conditions:

All direct support for research activities will follow the host country’s requirements for approval of research plans and any research involving human subjects.

C linical or Operational Research

a) For a ny issues concerning human research subjects, the Health Program will follow the U.S. National Institutes for Health (NIH) and RSA requirements in consultation with Centers for Disease Control and Prevention (CDC) Advisors and USAID Health Officers. See 45 CFR Part 45. Protection of Human Subjects at the following link: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm

b) This condition is especially noteworthy given that USAID/SA is collaborating with WHO, CDC and National Health Laboratory Service to explore STI prevalence in mining communities. USAID, DOH and Family Health International (FHI) are also completing a feasibility study on provision of STI treatment kits in public sector facilities in South Africa.

The above conditions apply to any components of the HIV/AIDS, reproductive health, PHC, ARV, STI management, and TB case detection and/or treatment compliance activities which involve clinical or operational research under the Health Program.

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3.3.9 SUB-GRANTS AND SUB-CONTRACTS IN SUPPORT OF DEVELOPMENT OBJECTIVE 3

The Health Program administers small grants to CBOs, NGOs, and FBOs for a range of activities, not yet fully defined. Several mechanisms will be invoked for the provision of sub-awards, normally via the Prime awardees, such as for the Umbrella Grant Mechanism (UGM). The grants will address the following sorts of objectives:

to provide palliative care to households to HIV/AIDS, to improve and expand TB programs via DOTS programs in rural, urban and peri-urban areas, to support community governance structures, to train youth organizations in prevention of HIV/AIDS/STDS and TB, and to strengthen HIV/AIDS CBOs and smaller NGOs.

None of these grants is expected to have an adverse impact on the environment. However, these activities may require an additional, or subsidiary, environmental screening process outlined below.

Sub-Granting activities (current or yet to be devised) under the Health Program may require an environmental screening process:

a) Given that the specifics of a subgrantee’s activities to be funded under are not always known at the time prime’s agreement is executed, grantees or sub-grantees under the prime will be required to undertake a subsidiary environmental review intended to identify potential environmental problems and to identify appropriate mitigation measures Based on the results of the subsidiary review, an Environmental Review Report may be required. The ERF/ERR process described in Annex 4 provides guidance and examples, such as small-scale infrastructure, sanitation, water provision, healthcare waste management, activities located in or near ecologically sensitive areas, and the like.

b) The Health Team, in collaboration with Mission Environmental Officer, has the responsibility to ensure that the supplemental environmental review process is applied in conformity with the procedures described below:

Subsidiary Environmental Review Process:c) Implementing partners will screen proposed activities according to a Subsidiary Review

process by applying an Environmental Review Form (ERF) and preparing an Environmental Review Report (ERR) as found on the GEMS website at http://www.usaidgems.org/subsidiary.htm. As described there, the screening categories include the following: Category 1 (very low risk). Activities that would normally qualify for a categorical exclusion under Reg. 216; Category 2 (medium risk). Activities that would normally qualify for a negative determination under Reg. 216; Category 3 (high risk). Activities that have a clear potential for undesirable environmental impacts and typically under Reg. 216 require an Environmental Assessment; Category 4 (very high risk). Activities that either USAID cannot fund or for which specific findings must be made in an Environmental Assessment prior to funding.

d) The Health team is responsible for obtaining the implementing partners’ categorization of activities. Then, the Mission Environmental Officer (MEO) shall be responsible, first, for clearing the implementing partner’s category determination. Further, the MEO must approve all Category 2 Environmental Reviews individually or in groups. The MEO will review and pass on to the REO and BEO any Category 3 reviews and, as s/he determines the need,

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Category 2 documentation. All Category 3 Environmental Reviews must be approved by the BEO. Any activities that fall within Category 4 will be immediately referred to the REO and BEO, unless the MEO rejects them and thereby denies implementation of the subject activities.

e) The implementing partners will take into consideration potential environmental impacts and their mitigation and monitoring measures; mitigating through avoidance, design, implementation, follow-up and other means to achieve an environmentally-sound project design and program sustainability.

f) Implementing partners will take into account the Africa Bureau Environmental Guidelines for Small-Scale Activities in Africa8 and other appropriate Africa Bureau and generic environmental assessment sources to assist in determining what potential projects impacts should be of concern for different types of development activities in various settings, and which impacts to mitigate and monitor for a particular development activity.

g) Implementing partners must include in their reports to USAID/SA an environmental review of projects and all proposed environmental mitigation and monitoring requirements. Once the environmental review reports are approved, mitigation measures and monitoring procedures stated in the environmental review report should be considered as a requirement. Additionally, project implementers should ensure that the agreed-upon mitigation and monitoring measures are in place.

h) The Health Program shall report to the MEO on an annual basis (or more frequently) on the status of environmental screening and review, and the implementation of required mitigation and monitoring measures. This will include the review of implementing partners' progress and annual reports to help determine if environmental mitigation and monitoring procedures are in place, including their expected performance, and periodic field visits facilitated by the Health team by the MEO and/or the REO.

The Health Program will ensure completion of the Environmental Screening Form in Annex 4.

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4.0 General Project Implementation and Monitoring RequirementsIn addition to the specific conditions above, the negative determinations recommended in this IEE are contingent on full implementation of the following general monitoring and implementation requirements:

1. IP Briefings on Environmental Compliance Responsibilities. The Health team shall provide each Implementing Partner (hereinafter IP), with a copy of this IEE; each IP shall be briefed on their environmental compliance responsibilities by their cognizant C/AOR. During this briefing, the specific IEE conditions applicable to the IP’s activities will be identified.

2. Development of EMMP. Each IP whose activities are subject to one or more conditions set out in section 3 of this IEE shall develop and provide for C/AOR review and approval an Environmental Mitigation and Monitoring Plan (EMMP) documenting how their project will implement and verify all IEE conditions that apply to their activities.

8 Click on: http://www.encapafrica.org/SmallScaleGuidelines.htm.

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These EMMPs shall identify how the IP shall assure that IEE conditions that apply to activities supported under subcontracts and subgrants are implemented. (In the case of large subgrants or subcontracts, the IP may elect to require the subgrantee/subcontractor to develop their own EMMP.)

The EMMP is approved when it is signed by the AOR/COR/AM and MEO or REA.

(Note: The AFR EMMP Factsheet provides EMMP guidance and sample EMMP formats: http://www.usaidgems.org/Documents/lopDocs/ENCAP_EMMP_Factsheet_22Jul2011.pdf ).

3. Integration and implementation of EMMP. Each IP shall integrate their EMMP into their project work plan and budgets, implement the EMMP, and report on its implementation as an element of regular project performance reporting, e.g., quarterly or semi-annual progress reports.

IPs shall assure that sub-contractors and sub-grantees integrate implementation of IEE conditions, where applicable, into their own project work plans and budgets and report on their implementation as an element of sub-contract or grant performance reporting.

4. Integration of compliance responsibilities in prime and sub-contracts and grant agreements.

a. The Health team shall assure that any future contracts or agreements for implementation of health portfolio activities, and/or significant modification to current contracts/agreements shall reference and require compliance with the conditions set out in this IEE, as required by ADS 204.3.4.a.6 and ADS 303.3.6.3.e.

b. IPs shall assure that future sub-contracts and sub-grant agreements, and/or significant modifications to existing agreements, reference and require compliance with relevant elements of these conditions.

5. Assurance of sub-grantee and sub-contractor capacity and compliance. IPs shall assure that sub-grantees and subcontractors have the capability to implement the relevant requirements of this IEE. The IP shall, as and if appropriate, provide training to subgrantees and subcontractors in their environmental compliance responsibilities and in environmentally sound design and management (ESDM) of their activities.

6. South Africa Health team monitoring responsibility. As required by ADS 204.5.4, the Health team will actively monitor and evaluate whether the conditions of this IEE are being implemented effectively and whether there are new or unforeseen consequences arising during implementation that were not identified and reviewed in this IEE. If new or unforeseen consequences arise during implementation, the team will suspend the activity and initiate appropriate, further review in accordance with 22 CFR 216. USAID Monitoring shall include regular site visits.

7. New or modified activities. As part of its Work Plan, and all Annual Work Plans thereafter, IPs, in collaboration with their C/AOR, shall review all on-going and planned activities to determine if they are within the scope of this IEE.

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

Any ongoing activities found to be outside the scope of the approved Regulation 216 environmental documentation shall be modified to comply or halted until an amendment to the documentation is submitted approved.

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8. Compliance with Host Country Requirements. Nothing in this IEE substitutes for or supersedes IP, subgrantee and subcontractor responsibility for compliance with all applicable host country laws and regulations. The IP, subgrantees and subcontractor must comply with host country environmental regulations unless otherwise directed in writing by USAID. However, in case of conflict between host country and USAID regulations, the latter shall govern.

9. G2G & GoSA long-term plans for HIV/AIDS related health care provision. For the purposes of implementation of this IEE, it will be important for the Health Program to regularly assess the degree to which GoSA will choose to continue to outsource HIV/AIDs services through NGOs or will shift to delivering these services directly through government employees. With talks of the “PEPFAR transfer” of the treatment portfolio and declining PEPFAR budget, it is important to know the Ministry of Health’s long term plan so that USAID can provide the right types of support and capacity building to all the GoSA to deliver HIV/AIDs services. See Section 1.1.

10. With respect to the management of healthcare waste, this IEE defers to the Government of South Africa Procedures and Guidance for Disposal and Treatment Methods Suitable for Different Categories of Health Care Waste ( Annex 1).

11. USAID South Africa Health team monitoring responsibility. As required by ADS 204.5.4, the Health team will actively monitor and evaluate whether the conditions of this IEE are being implemented effectively and whether there are new or unforeseen consequences arising during implementation that were not identified and reviewed in this IEE. If new or unforeseen consequences arise during implementation, the team will suspend the activity and initiate appropriate, further review in accordance with 22 CFR 216. USAID Monitoring shall include regular site visits.

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LIST OF ANNEXES

Annex 1: Government Of South Africa Procedures And Guidance For Disposal And Treatment Methods Suitable For Different Categories Of Health Care Waste

Annex 2. Healthcare Waste Management For Small Scale Facilities: Minimal Program Checklist And Action Plan

Annex 3: Additional Guidance For Installation Of “Park Homes”

Annex 4: Subsidiary Environmental Review Process

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ANNEX 1:

GOVERNMENT OF SOUTH AFRICA PROCEDURES AND GUIDANCE FOR DISPOSAL AND TREATMENT METHODS SUITABLE FOR DIFFERENT CATEGORIES OF HEALTH CARE WASTE

The GoSA follows established guidelines for medical waste disposal and falls under the jurisdiction of the Waste Management Act. An overview of guidelines for medical waste disposal is provided below. Detailed GoSA guidelines for health care waste management (HCWM) and disposal are available online (http://law.resource.org/pub/za/ibr/za. sans . 10248 .2004.pdf ).

The draft (2004) Policy Guidelines for the Management of Healthcare Waste (drafted by Johann Kluge, Department of Health, South Africa) develops practical guidance for healthcare facilities. It lists the applicable legislation as follows:

The destruction of pharmaceutical waste should be done in compliance with Regulation 27(1) (a) (b) (c), Regulation 27(2) and Regulation 27(3) of the Medicines and Related Substances Control Amendment Act (Act 90 of 1997) as required by section 35 of the Act.

Cognizance should be taken of the Treasury Regulations section 19.6 issued in terms of the Public Finance Management Act, 1999

Transportation of healthcare waste from the producer of the waste to the final disposal site should be done in compliance with the pertinent legislation.

Cognizance should be taken of the requirements of the Environment Conservation Act No 73 of 1989 and the regulations with regard to waste management.

The GoSA guidelines, South African Bureau of Standards (SABS) of Code of Practices, Handling and Disposal of Waste Materials within Health Care Facilities, Document Number - SABS 0248:1993 -- was originally approved by the Council of the South African Bureau of Standards on 25 February 19939. These standards established specific guidelines for the segregation, collection, movement and storage of the waste materials within health care facilities. The main objective is to decrease injury to personnel and the possible risks of spreading infection due to the improper handling of waste materials. The main features of this standard are as follows: a) a series of waste categories based on the WHO Report, Safe Management of Wastes from Health-care Activities (A Prüs, Department of Protection of the Human Environment, 1999) has been introduced; b) a clause on pharmaceutical waste appears in the standard; c) a classification system for waste containers has been developed; d) various procedures reflect modern current infection control practices; and e) the standard has been written in such a way as to reflect the practical aspects of handling waste.

Other operative guidance and regulations in South Africa include:

Department of Environmental Affairs and Tourism, White Paper on Integrated Pollution and Waste Management for South Africa, A Policy on Pollution Prevention, Waste Minimisation, Impact Management and Remediation.

Guidelines for the Destruction of Schedule 5 Medicines and Substances (May 2003). Medicines Control Council (MCC) & Department of Health, Republic of South Africa.

These guidelines should be read, and implemented by the Health Team, as applicable. These were developed in conjunction with the Medicines and Related Substances Control Act (Act 101 of 1965), and its supporting regulations.

9 Note: SABS 0248 has been withdrawn. It is replaced by SABS 10248, which was approved May 28 2004.

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As these guidelines are constantly evolving due to harmonisation initiatives and new scientific developments, the Health Program and its institutional contractors and grantees are advised to always consult the latest information available. The Medicines Control Council endeavours to keep abreast of such developments and to keep its application requirements and evaluation procedures and policies in line with “best international practice.” All destruction must take place in accordance with local municipal regulations regarding the disposal of chemical or medicinal waste. The applicant (person requesting destruction) may be requested to prove that the method of destruction is in accordance with such regulations.

Practical Guidance Documents:

General guidance on medical waste disposal, good framework documents: http://www.path.org/projects/health_care_waste_resources.php

Information on requirements for waste collectors in South Africa: http://www.iwmsa.co.za/site-content/faqs.html#wastelic

Compact incinerator technology: http://www.infrastructurene.ws/2012/05/04/technological-breakthrough-for-sas-medical-waste-industry/

Health care waste management (HCWM) press stories indicate lack of enforcement and capacity with competition, and cost -cutting as major drivers for improper disposal of health care waste (http://www.citypress.co.za/news/medical-waste-disposal-a-mess-20110507/, http://www.environment.co.za/environmental-issues-news/human-tissue-old-bandages-and-used-syringes-pile-up-as-waste-disposal-crisis-spirals-out-of-control.html). The following issues impact proper disposal of health care waste in South Africa:

o Companies have to refrigerate anatomical waste for weeks while they wait for the use of an incinerator;

o Many send loaded trucks across the country to get to incinerators that can accommodate them, while others illegally dump their waste on vacant land to save money;

o Owners of some incinerator plants are battling backlogs of waste and are unable to cope with the volumes;

o Some incinerator owners charge companies high prices, encouraging waste companies to stash or dump their waste;

o At least one major player in the waste industry is under investigation for disposal-site violations; o More than 1000 illegal incinerators exist at hospitals.

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Method

Infectious Waste (laboratory cultures, excreta)

Sharps (needles, blades,

broken glass)

Pharmaceutical Waste (expired

pharmaceuticals, boxes

contaminated by pharmaceuticals)

Chemical Waste (laboratory reagents, solvents)

Radioactive Waste (unused liquids from laboratory research)

Rotary kiln 2

Pyrolytic incinerator 1 1 2

Single-chamber incinerator

2

Drum or brick incinerator

Chemical disinfection

Wet thermal treatment

Microwave irradiation

Encapsulation 1

Safe burial on hospital premises

1 1

Sanitary landfill 1

Discharge to sewer 1 Low-level liquid waste

Inertization

Other Return to supplier Return to supplier Decay by storage

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Annex 2. HEALTHCARE WASTE MANAGEMENT FOR SMALL SCALE FACILITIES: MINIMAL PROGRAM CHECKLIST10 AND ACTION PLAN

Small-scale facilities require a sound healthcare waste management system to minimize adverse health and environmental impacts caused by their wastes. The following elements of a complete minimal healthcare waste management program should be in place in all facilities:

s/ActionsIn Place?

To be DoneBy Whom

Written plans and procedures1. A written waste management plan

describing all the practices for handling, storing, treating, and disposing of hazardous and non-hazardous waste, as well as types of worker training required.

2. Internal rules for generation, handling, storage, treatment, and disposal of healthcare waste.

3. Clearly assigned staff responsibilities that cover all steps in the waste management process.

4. Staff waste handling training curricula or a list of topics covered.

5. Waste minimization, reuse, and recycling procedures.

Staff Training, Practices, and Protection6. Staff trained in safe handling, storage, treatment, and

disposal. Does staff exhibit good hygiene, safe sharps handling, proper use of protective clothing, proper packaging and labeling of waste, and safe storage of waste? Does staff know the correct responses for spills, injury, and exposure?

7. Protective clothing available for workers who move and treat

10Adapted from “Healthcare waste: Generation, handling, treatment and disposal,” in Environmental Guidelines for Small Scale Activities in Africa, 2nd Edition (Working Draft). Washington, D.C., USAID AFR/SD. 2002. http://www.encapafrica.org/EGSSAAsectionsfrom18Jun01draft/EGSSAA3-13medwastedraft.pdf

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collected infections waste such as surgical masks and gloves, aprons, and boots.

Staff Training, Practices, and Protection cont’d.8. Good hygiene practices. Are soap and, ideally, warm water

readily available workers to use and can workers be observed regularly washing.

9. Workers vaccinated for against viral hepatitis B, tetanus infections, and other endemic infections for which vaccines are available.

Handling and Storage Practices10. Temporary storage containers and designated storage

locations.11. Are there labeled, covered, leak-proof, puncture-resistant

temporary storage containers for hazardous healthcare wastes?

12. Minimization, reuse, and recycling procedures.Does the facility have good inventory practices for chemicals

and pharmaceuticals, i.e.:o use the oldest batch first;o open new containers only after the last one is empty;

procedures to prevent products from being thrown out during routine cleaning; and

13. A waste segregation system.Is general waste separated from infectious/hazardous waste?Is sharp waste (needles, broken glass, etc.) collected in

separate puncture-proof containers?Are other levels of segregation being applied e.g. hazardous

liquids, chemicals and pharmaceuticals, PVC plastic, and materials containing heavy metals ((these are valuable, but less essential)?

14. Temporary storage containers and designated storage locations.Are there labeled, covered, leak-proof, puncture-resistant

temporary storage containers for hazardous healthcare wastes?

Is the location distant from patients or food?

Treatment Practices

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1.Frequent removal and treatment of wasteAre wastes collected daily?Are wastes treated with a frequency appropriate to the

climate and season?o Warm season in warm climates within 24 hrso In the cool season in warm climates within 48 hrso In the warm season in temperate climates within

48 hrso In the cool season in temperate climates within 72 hrs

15.Treatment mechanisms for hazardous and highly hazardous waste. ( The most important function of treatment is disinfection). Are wastes being burned in the open air, in a drum or brick

incinerator, or a single-chamber incinerator?If not are they being buried safely (in a pit with an

impermeable plastic or clay lining)?Is the final disposal site (usually a pit) surrounded by fencing

or other materials and in view of the facility to prevent accidental injury or scavenging of syringes and other medical supplies?

If the waste is transported off-site, are precautions taken to ensure that it is transported and disposed of safely?

For more detailed checklists and guidance consult: Safe management of wastes from health-care activities, edited by A. Prüss, E. Giroult and P. Rushbrook. Geneva, WHO, 1999, 228 pages. Available at: http://www.who.int/water_sanitation_health/Environmental_sanit/MHCWHanbook.htm. English (French and Spanish in preparation).

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ANNEX 3: ADDITIONAL GUIDANCE FOR INSTALLATION OF “PARK HOMES”

Park homes are being used by several Health Program partners as a way of making space for expanding services.  Park Homes are easy-to-assemble, semi-permanent structures which provide a cost effective and efficient alternative to construction of permanent facilities.  Park Homes appear to be useable for nearly 10 years. 

Installation of Park Homes requires placement of a cement foundation and proper functioning involves the use of water and electricity. Therefore, installation of Park Homes may have adverse environmental impacts and are subject to environmental screening and mitigation actions outlined in Annex 4 for small-scale construction activities.

Quality of Park Homes is not consistent across vendors. The following recommendations have been developed by the Mission Environmental Officer (MEO) for USAID/South Africa to assist partners in planning for purchase and appropriate use of Park Homes:

Recommendations When choosing a vendor, consideration should be given to more than just the lowest price, such

as: o It’s often easier and faster for vendors in the vicinity to provide maintenance and repairs; o The partner should ensure some type of guarantee for proper installation (e.g. proper

grading of the land) as part of the contract and should not pay the final installment until things are functioning as promised;

o If possible, the partner should get a certification from the vendor that water and electricity meet South African standards, specifically those of the DOH. Because Healthcare wastes maybe generated at Park Homes, water and sanitation plans must be in place to ensure high standards of hygiene, treatment of human and healthcare waste, and disinfection and disposal of waste water.

Clear quality specifications should be included in the tender so the partner is not forced to simply choose the lowest cost vendor.

For lots that are not paved, the partner (or USAID) may want to consider doing so for sustainability purposes. 

Site plans should include some type of shelter for the waiting area (a simple covering to shield patients from sun and rain).

There should be a plan in place to ensure sustainability of the Park Home (at least through their expected physical life span) when/if USG funding ends.

Rooms should be wheelchair accessible.

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ANNEX 4: SUBSIDIARY ENVIRONMENTAL REVIEW PROCESS

The ERF and ERR descriptions and forms can also be found at http://www.usaidgems.org/subsidiary.htm.

Southern AfricaInstructions for environmental review of XXX Program Subprojects/Sub-grantsNote: These instructions accompany the attached “Environmental Review Form for USAID/XXX Program/Project Activities” (ERF). Follow, but DO NOT SUBMIT, these instructions.

WHO MUST SUBMIT THE ENVIRONMENTAL REVIEW FORM (ERF)?ALL Implementing Partners seeking to implement [describe qualifying activities] under the XXX Program/Project must complete, sign and submit the ERF to [insert name & email of C/AOR].

Authority: Use of the ERF for these activities is mandated by the governing Initial Environmental Examination (IEE) for the XXX Project/Program. The IEE can be downloaded at: [insert URL].

NO IMPLEMENTATION WITHOUT AN APPROVED ERF The proposed activities cannot be implemented and no “irreversible commitment of resources” for these activities can be made until the ERF (including Environmental Review Report, if required, see Step 4, below) is cleared by the C/AOR, the Mission Environmental Officer (MEO) and the Regional Environmental Advisor (REA).

NOTE: USAID may deny clearance to the ERF, or may require modification and re-submission for clearance.

ENVIRONMENTAL MANAGEMENT REQUIREMENTS RESULTING FROM THE ERFIf the ERF requires preparation of an Environmental Review Report (see Step 4, below), any environmental management measures specified in the approved Environmental Review Report MUST be implemented.

SITUATIONS IN WHICH ADDITIONAL ENVIRONMENTAL REVIEW IS REQUIRED. If the ERF finds that one of more of the proposed activities has the potential to cause significant adverse environmental impacts, the activities must be redesigned or an IEE or full Environmental Assessment must be conducted and approved prior to implementation.

If USAID determines that the proposed activities are outside the scope of activities for which use of this form is authorized, the activities must be redesigned or an IEE or IEE Amendment will be required.

In either situation, USAID will confer with the partner to determine next steps. Note: If an IEE or EA is required, all environmental management measures specified in the IEE or EA must then be implemented.

STEP 1. PROVIDE REQUESTED “APPLICANT INFORMATION” (SECTION A OF THE ERF)

STEP 2. LIST ALL PROPOSED ACTIVITIESIn Section B of the form, list all proposed activities.

Activities are a desired accomplishment or output: e.g. seedling production, road rehabilitation, school construction. Each activities has entailed actions—for example, road rehabilitation includes survey, grading, culvert construction, compaction, etc. Be aware of these entailed actions, but do NOT list them.

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AFR Environmental Review Form Instructions20 Dec 2010

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List activities DESCRIPTIVELY. For example, “training” is not a sufficient activity listing. The listing must specify WHO is being trained, and in WHAT.

STEP 3A. SCREENING: IDENTIFY LOW-RISK AND HIGH-RISK ACTIVITIESFor each activity you have listed in Section B of the form, refer to the list below to determine whether it is a listed low-risk or high-risk activity.

If an activity is specifically identified as “very low risk” or “high risk” in the list below, indicate this in the “screening result” column in Section B of the form.

Very low-risk activities (Activities with low potential for adverse biophysical or

health impacts; including §216.2(c)(2))

High-risk activities(Activities with high potential for adverse biophysical or

health impacts; including §216.2(d)(1))

Provision of education, technical assistance, or training. (Note that activities directly affecting the environment. do not qualify.)Community awareness initiatives.Controlled agricultural experimentation exclusively for the purpose of research and field evaluation confined to small areas (normally under 4 ha./10 acres). This must be carefully monitored and no protected or other sensitive environmental areas may be affected).Technical studies and analyses and other information generation activities not involving intrusive sampling of endangered species or critical habitats.Document or information transfers.Nutrition, health care or family planning, EXCEPT when (a) some included activities could directly affect the environment (construction, water supply systems, etc.) or (b) biohazardous (esp. HIV/AIDS) waste is handled or blood is tested.Small-scale construction. Construction or repair of facilities if total surface area to be disturbed is under 10,000 sq. ft. (approx. 1,000 sq. m.) (and when no protected or other sensitive environmental areas could be affected).Intermediate credit. Support for intermediate credit arrangements (when no significant biophysical environmental impact can reasonably be expected).Maternal and child feeding conducted under Title II of Public Law 480.Title II Activities. Food for development programs under Title III of P.L. 480, when no on-the-ground biophysical interventions are likely.Capacity for development. Studies or programs intended to develop the capability of recipients to engage in development planning. (Does NOT include activities directly affecting the environment)Small-scale Natural Resource Management activities for which the answer to ALL SUPPLEMENTAL SCREENING QUESTIONS (see Natural Resources supplement) is “NO.”

River basin developmentNew lands developmentPlanned resettlement of human populations.Penetration road building, or rehabilitation of roads (primary, secondary, some tertiary) over 10 km length, and any roads which may pass through or near relatively undegraded forest lands or other sensitive ecological areasSubstantial piped water supply and sewerage construction.Major bore hole or water point construction.Large-scale irrigation; Water management structures such as dams and impoundmentsDrainage of wetlands or other permanently flooded areas.Large-scale agricultural mechanization.Agricultural land leveling.Procurement or use of restricted use pesticides, or wide-area application in non-emergency conditions under non-supervised conditions. (Consult MEO.)Light industrial plant production or processing (e.g., sawmill operation, agro-industrial processing of forestry products, tanneries, cloth-dying operations).

High-risk and typically not funded by USAID : Actions affecting protected areas and species. Actions determined likely to significantly degrade protected areas, such as introduction of exotic plants or animals.Actions determined likely to jeopardize threatened & endangered species or adversely modify their habitat (esp. wetlands, tropical forests)Activities in forests, including: Conversion of forest lands to rearing of livestock Planned colonization of forest lands Procurement or use of timber harvesting

equipment Commercial extraction of timber Construction of dams or other water control

structures that flood relatively undegraded forest lands

Construction, upgrading or maintenance of roads that pass through relatively non-degraded forest lands. (Includes temporary haul roads for logging or other extractive industries)

(This list of activities is taken from the text of 22 CFR 216 and other applicable laws, regulations and directives)

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STEP 3B: IDENTIFYING ACTIVITIES OF UNKNOWN OR MODERATE RISK.All activities NOT identified as “very low risk” or “very high risk” are considered to be of “unknown or moderate risk.” Common examples of moderate-risk activities are given in the table below.

Check “moderate or unknown risk” under screening results in Section B of the form for ALL such activities.

Common examples of moderate-risk activitiesCAUTION: If ANY of the activities listed in this table may adversely impact (1) protected areas, (2) other sensitive environmental areas, or (3) threatened and endangered species and their habitat, THEY ARE NOT MODERATE RISK. All such activities are HIGH RISK ACTIVITIES.

Small-scale agriculture, NRM, sanitation, etc. (You may wish to define what “small scale” means for each activity)Agricultural experimentation. Controlled and carefully monitored agricultural experimentation exclusively for the purpose of research and field evaluation of MORE than 4 ha.

NOTE Biotechnology/GMOs: No biotechnology testing or release of any kind are to take place within an assisted country until the host countries involved have drafted and approved a regulatory framework governing biotechnology and biosafety.All USAID-funded interventions which involve biotechnologies are to be informed by the ADS 211 series governing "Biosafety Procedures for Genetic Engineering Research". In particular this guidance details the required written approval procedures needed before transferring or releasing GE products to the field.

Medium-scale construction. Construction or rehabilitation of facilities or structures in which the surface area to be disturbed exceeds 10,000 sq. ft (1000 sq meters) but funding level is $200,000 or less. (E.g. small warehouses, farm packing sheds, agricultural trading posts, produce market centers, and community training centers.)Rural roads. Construction or rehabilitation of rural roads meeting the following criteria: Length of road work is less than ~10 km No change in alignment or right of way Ecologically sensitive areas are at least 100 m away

fr om the road and not affected by construction or changes in drainage.

No protected areas or relatively undegraded forest are within 5 km of the road.

Title II & III Small-Scale Infrastructure. Food for Development programs under Title II or III, involving small-scale infrastructure with the known potential to cause environmental harm (e.g., roads, bore holes).Quantity imports of commodities such as fertilizers

Sampling. Technical studies and analyses or similar activities that could involve intrusive sampling, of endangered species or critical habitats. (Includes aerial sampling.)Water provision/storage. Construction or rehabilitation of small-scale water points or water storage devices for domestic or non-domestic use. Water points must be located where no protected or other sensitive environmental areas could be affected.

NOTE: USAID guidance on water quality requires testing for arsenic, nitrates, nitrites and coliform bacteria.

Support for intermediate credit institutions when indirect environmental harm conceivably could result.Institutional support grants to NGOs/PVOs when the activities of the organizations are known and may reasonably have adverse environmental impact.Pesticides. .Small-scale use of USEPA-registered, least-toxic general-use pesticides. Use must be limited to NGO-supervised use by farmers, demonstration, training and education, or emergency assistance.

NOTE: Environmental review (see step 5) must be carried out consistent with USAID Pesticide Procedures as required in Reg. 16 [22 CFR 216.3(b)(1)].

Nutrition, health care or family planning, if (a) some included activities could directly affect the environment (e.g., construction, supply systems, etc.) or (b) biohazardous healthcare waste (esp. HIV/AIDS) is produced, syringes are used, or blood is tested.

STEP 4. DETERMINE IF YOU MUST WRITE AN ENVIRONMENTAL REVIEW REPORTExamine the “screening results” as you have entered them in Table 1 of the form.

If ALL the activities are “very low risk,” then no further review is necessary. In Section C of the form, check the box labeled “very low risk activities.” Skip to Step 8 of these instructions.

If ANY activities are “unknown or moderate risk,” you MUST complete an ENVIRONMENTAL REVIEW REPORT addressing these activities. Proceed to Step 5.

If ANY activities are “high risk,” note that USAID’s regulations usually require a full environmental assessment study (EA). Because these activities are assumed to have a high probability of causing significant,

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adverse environmental impacts, they are closely scrutinized. Any proposed high-risk activity should be discussed in advance with USAID. Activity re-design is often indicated.

In some cases, it is possible that reasonable, achievable mitigation and monitoring can reduce or eliminate likely impacts so that a full EA will not be required. If the applicant believes this to be the case, the Environmental Review Report must argue this case clearly and thoroughly. Proceed to Step 5.

STEP 5. WRITE THE ENVIRONMENTAL REVIEW REPORT, IF REQUIREDThe Environmental Review Report presents the environmental issues associated with the proposed activities. It also documents mitigation and monitoring commitments. Its purpose is to allow the applicant and USAID to evaluate the likely environmental impacts of the project.

For a single, moderate risk activity, the Environmental Review Report is typically a SHORT 4–5 page document. The Report will typically be longer for (1) multiple activities; (2) activities of high or unknown risk; and/or (3) when a number of impacts and mitigation measures are being identified and discussed.

The Environmental Review Report follows the outline below. Alternate outlines are acceptable, so long as all required information is covered.

A. Summary of Proposal. Very briefly summarize background, rationale and outputs/results expected. (Reference proposal, if appropriate).

B. Description of Activities. For all moderate and high-risk activities listed in Section B of the ERF, succinctly describe location, siting, surroundings (include a map, even a sketch map). Provide both quantitative and qualitative information about actions needed during all project phases and who will undertake them. (All of this information can be provided in a table). If various alternatives have been considered and rejected because the proposed activity is considered more environmentally sound, explain these.

C. Site-specific Environmental Situation & Host Country Requirements. Describe the environmental characteristics of the site(s) where the proposed activities will take place. Focus on site characteristics of concern—e.g., water supplies, animal habitat, steep slopes, etc. With regard to these critical characteristics, is the environmental situation at the site degrading, improving, or stable?

Also note applicable host country environmental regulations and/or policies. (For example, does the project require host country environmental review or permitting? Building approval? Etc.)

NOTE: provide site-specific information in this section, NOT country-level information. General information about country level conditions should already be contained in the IEE governing the XXX project/program.

D. Environmental Issues, Mitigation Actions, and Findings. For ALL proposed activities

i. Briefly note the potential environmental impacts or concerns presented by the proposed activities (if any). For guidance, refer to Africa Bureau’s Environmental Guidelines for Small-Scale Activities; available at www.encapafrica.org/egssaa.htm.

As per the Small-Scale Guidelines, consider direct, indirect and cumulative impacts across the activity lifecycle (i.e. impacts of site selection, construction, and operation, as well as any problems that might arise with abandoning, restoring or reusing the site at the end of the anticipated life of the facility or activity). Note that “environment” includes air, water, geology, soils, vegetation, wildlife, aquatic resources, historic, archaeological or other cultural resources, people and their communities, land use, traffic, waste disposal, water supply, energy, etc.)

ii. Assess the extent to which these potential impacts and concerns are significant in the context of the specific activity design and site.

iii. Set out the mitigation actions to be employed to address these issues.

Mitigation actions are means taken to avoid, reduce or compensate for impacts. Mitigation measures must be reasonable and implementable by field staff. They should be consistent with the good practice guidance

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provided in Africa Bureau’s Environmental Guidelines for Small-Scale Activities; (www.encapafrica.org/egssaa.htm.) Cite this or other guidance used for mitigation design.

iv. Reach one of three findings regarding the potential impacts:

a. Significant adverse impacts are very unlikely. Of its nature, the activity in question is very unlikely to result in significant, adverse environmental impacts. Special mitigation or monitoring is not required. Note: this conclusion is rarely appropriate for high-risk activities.

b. With implementation of the specified mitigation and monitoring, significant adverse impacts are very unlikely.

c. Significant adverse impacts are possible. That is, it is not possible to rule out significant adverse environmental impacts even given reasonable, attainable mitigation and monitoring.

In this case, USAID and the partner will consult regarding next steps. If the activity is to go forward in its current form, additional analysis in the form of an IEE or EA will be required.

Format and structure of this section. Choose a format and structure that presents the necessary information clearly and succinctly.

Table formats can be used. In the example below, the proposed activity was construction of an institutional facility on a 7500m3 plot bisected by a seasonal stream providing drainage to the local area. One potential impact of the activity was reduction of or alteration to the drainage eco-service provided by the seasonal stream.

Issue or cause for concern

Analysis Finding and conditions/mitigation actions

The seasonal stream running through the plot drains an area of at least 2 km2 to the WNW.

Diminution or alteration to this drainage “service” could result in increased upstream pooling & flooding during the rainy season, with associated property damage and increased breeding habitat for disease vectors.

As indicated at left, this impact only arises if the drainage “service “ provided by the seasonal stream is diminished or altered in some adverse manner.

So long as compound design maintains the existing service level and construction is managed without disruption to stream flow, actual adverse impact will be negligible or zero.

Per analysis at left, this potential impact is not significant, so long as the following mitigations are implemented:

1. Total stream capacity cannot be diminished by the development of the compound. (Stream channel on average is 3m x 1m.)

2. The stream must remain substantially in the same channel and cannot, e.g., be re-routed around the property.

3. If construction will result in an interruption to stream flow, provision must be made to provide a temporary bypass. Temporary damming of stream flow is not permissible.

4. Post-construction, the stream bed within the property, including point-of-entry (e.g. via culvert under perimeter wall) must be maintained free of obstructions to flow.

E. Environmental Mitigation and Monitoring Plan (EMMP). Set out how compliance with mitigation actions will be monitored/verified. This includes specifying WHO will be responsible for the various mitigation actions, and HOW implementation of the mitigation actions will be tracked/verified.

Also specify how you will report to USAID on the implementation of mitigation actions. (You are REQUIRED to provide your C/AOR with sufficient information on the status of mitigation implementation for USAID to effectively fulfill its oversight and performance monitoring role.)

Again, choose a format and structure that presents the necessary information clearly and succinctly. EMMPs are typically in table format, and often include a compliance log or “monitoring record” section that records implementation status of the various mitigation actions. The EMMP with current monitoring log can then simply be submitted to the C/AOR with the quarterly or 6-month project report, satisfying the environmental compliance reporting requirement. .

The most basic EMMP format is

Mitigation action Responsible Party Monitoring/Verification Method Monitoring Record (date, result, corrective actions taken, if any)

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For additional EMMP formats and examples, see the ENCAP EMMP factsheet, available via www.encapafrica.org/meoEntry.htm

F. Other Information. Where possible and as appropriate, include photos of the site and surroundings; maps; and list the names of any reference materials or individuals consulted.

(Pictures and maps of the site can substantially reduce the written description required in parts B & C)

STEP 6. TRANSCRIBE FINDINGS FROM THE ENVIRONMENTAL REVIEW REPORT TO THE ERF For each high-risk or unknown/moderate-risk activity, transcribe your finding from the environmental review report to the last column of Section B of the ERF.

STEP 7. SIGN CERTIFICATIONS (SECTION C OF FORMER.)

STEP 8. SUBMIT FORM TO USAID C/AOR. BE SURE TO ATTACH THE ENVIRONMENTAL REVIEW REPORT, IF ANY.

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Southern AfricaEnvironmental Review Form for XXX Program subprojects/subgrants Follow, but do not submit, the attached instructions.

A. APPLICANT INFORMATION Organization Parent grant or project

URL of parent IEE:

Individual contact and title

Address, phone & email (if available)

Proposed subproject /subgrant(brief description)

Amount of funding requested

Period of performance

Location(s) of proposed activities

B. ACTIVITIES, SCREENING RESULTS, AND FINDINGSScreening result

(Step 3 of instructions)Findings

(Step 6 of instructions. Complete for all moderate/unknown and high-risk

activities ONLY)

Proposed activities(Provide DESCRIPTIVE listing. Continue on additional page if necessary)

Ver

y Lo

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isk

Hig

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isk*

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Sig

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Adv

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le1.

2.

3.

4.

5.

6.

7.

8.

*These screening results require completion of an Environmental Review Report

AFR Environmental Review Form20 Dec 2010

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C. CERTIFICATION:I, the undersigned, certify that:

1. The information on this form and accompanying environmental review report (if any) is correct and complete.

2. Implementation of these activities will not go forward until specific approval is received from the C/AOR.

3. All mitigation and monitoring measures specified in the Environmental Review Report will be implemented in their entirety, and that staff charged with this implementation will have the authority, capacity and knowledge for successful implementation.

(Signature) (Date)

(Print name) (Title)

NOTE: IF SCREENING RESULTS FOR ANY ACTIVITY ARE “HIGH RISK” OR “MODERATE OR UNKNOWN RISK,” THIS FORM IS NOT COMPLETE UNLESS ACCOMPANIED BY AN ENVIRONMENTAL REVIEW REPORT.

BELOW THIS LINE FOR USAID USE ONLY Notes:1. For clearance to be granted, the activity MUST be within the scope of the activities for which use of the ERF is authorized in the governing IEE. Review IEE before signature. If activities are outside this scope, deny clearance and provide explanation in comments section. The Partner, C/AOR, MEO and REA must then confer regarding next steps: activity re-design, an IEE or EA.

2. Clearing an ERF containing one or more findings that significant adverse impacts are possible indicates agreement with the analysis and findings. It does NOT authorize activities for which “significant adverse impacts are possible” to go forward. It DOES authorize other activities to go forward. The Partner, C/AOR, MEO and REA must then confer regarding next steps: activity re-design, an IEE or EA.

CLEARANCE RECORDC/AOR Clearance given

Clearance denied

(print name) (signature) (date)

USAID/XXXX MEO Clearance given

Clearance denied

(print name) (signature) (date)

Regional Env. Advisor (REA) Clearance given

Clearance denied

(print name) (signature) (date)

Bureau Env. Officer (BEO)* Clearance given

Clearance denied

(print name) (signature) (date)

C/AOR, MEO and REA clearance is required. BEO clearance is required for all “high risk” screening results and for findings of “significant adverse impacts possible. The BEO may review ”

Note: if clearance is denied, comments must be provided to applicant (use space below & attach sheets if necessary)

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NOTE TO INDIVIDUALS ADAPTING THE:

* SUPPLEMENTAL ENVIRONMENTAL REVIEW FORM FOR NRM ACTIVIES

FOR USE ON A PARTICULAR PROGRAM/ACTIVITY:

This supplement is oriented around major resource/issue clusters and asks “leading questions” about the actual potential for unintended harmful impacts, especially of CBNRM/ ecotourism activities.

Underlined & blue highlighted text MUST be modified to reflect project and mission name

Questions should be modified to respond to the needs of individual projects. This is intended to be a “living” document subject to adaptation.

DELETE THIS PAGE BEFORE MODIFYING/DISTRIBUTING THIS FORM

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Supplement to the Environmental Review Formfor Natural Resources ActivitiesAdditional Screening Criteria for Natural Resource Activities under XXX Progam

PURPOSEThis is a supplement to the “Instructions for environmental review of XXX Program/Project activities.” It is to be used for natural resources-based activities, including:

Community-Based Natural Resource Management (CBNRM)

Ecotourism

Natural resources-based enterprise development with micro- and small enterprises

This supplement provides additional questions to ascertain whether these proposed activities should be categorized as “very low risk:”

If the answers to ALL the questions that follow are “NO,” then the proposed natural resource-based activity is considered “very low risk.”

If the answer to ANY question is “YES,” the activity CANNOT be considered “very low risk.”

SCREENING CRITERIA

Will the activities… YES NO

Natural Resources

Accelerate erosion by water or wind?

Reduce soil fertility and/or permeability?

Alter existing stream flow, reduce seasonal availability of water resources?

Potentially contaminate surface water and groundwater supplies?

Involve the extraction of renewable natural resources?

Lead to unsustainable use of renewable natural resources such as forest products?

Involve the extraction of non-renewable natural resources?

Restrict customary access to natural resources?

Reduce local air quality through generating dust, burning of wastes or using fossil fuels and other materials in improperly ventilated areas?

Affect dry-season grazing areas and/or lead to restricted access to a common resource?

Lead to unsustainable or unnecessarily high water extraction and/or wasteful use?

Ecosystems and Biodiversity

Drain wetlands, or be sited on floodplains?

Harvest wetland plant materials or utilize sediments of bodies of water?

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Will the activities… YES NO

Lead to the clearing of forestlands for agriculture, the over-harvesting of valuable forest species?

Promote in-forest bee keeping?

Lead to increased hunting, or the collection of animals or plant materials?

Increase the risks to endangered or threatened species?

Introduce new exotic species of plants or animals to the area?

Lead to road construction or rehabilitation, or otherwise facilitate access to fragile areas (natural woodlands, wetlands, erosion-prone areas)?

Cause disruption of wildlife migratory routes?

Agricultural and Forestry Production

Have an impact on existing or traditional agricultural production systems by reducing seed availability or reallocating land for other purposes?

Lead to forest plantation harvesting without replanting, the burning of pastureland, or a reduction in fallow periods?

Affect existing food storage capacities by reducing food inventories or encouraging the incidence of pests?

Affect domestic livestock by reducing grazing areas, or creating conditions where livestock disease problems could be exacerbated?

Involve the use of insecticides, herbicides and/or other pesticides?

Community and Social Issues

Have a negative impact on potable water supplies?

Encourage domestic animal migration through natural areas?

Change the existing land tenure system?

Have a negative impact on culturally important sites in the community?

Increase in-migration to the area?

Create conditions that lead to a reduction in community health standards?

Lead to the generation of non-biodegradable waste?

Involve the relocation of the local community?

Potentially cause or aggravate land-use conflicts?

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