Attachment_J.6_SA_Initial_Environmental_Examination.pdf

FUNCTIONAL OBJECTIVE: INVESTING IN PEOPLE

PROGRAM AREA: HEALTH

INITIAL ENVIRONMENTAL EXAMINATION (IEE)

drose Typewritten Text

ATTACHMENT J.7

TABLE OF CONTENTS

Overview: Initial Environment Examination: Functional Objective “Investing in People” Program Area Health”

1. Summary of Findings…..……………………………………………………...3

2. Threshold Environmental Determinations…………………………………….4

Categorical Exclusions...……………………………………………………4 Negative Determinations with Conditions…………..……………………...5

3. Summary of Monitoring and Reporting Measures………………………...…12

4. Approval of Environmental Action Recommended………………………….14

Initial Environment Examination: Functional Objective “Investing in People” Program Area Health” Acronym List…………………………………………………………………15

1. Background and Project Description……………………………………...16

1.1 Purpose and Scope of IEE……………………………………………16

1.2 Overview of USAID/SA Health Program……………………………17

1.3 Implementation and Management Approach………………………...20

2. Country and Environmental Information (Baseline Information)………21

2. 1 Overview: Current Status of Health, HIV/AIDS, &TB in RSA……..21

2.2 Medical Waste Disposal Regulations, Policies & Practices in RSA…22

3. Evaluation of Programs with Respect to Environmental Impacts……….24

3.1 Procurement and Management of Public Health Commodities

3.2 Medical Waste Handling and Management………

3.3 Small-scale Construction and Renovation…………………………...27

3.4 Environmental Impacts Reviewed by Program Elements and Sub-

Elements……………………………………………………………...28

3.5 Sub-granting Activities……………………………………………….33

3.6 Clinical and Operational Research…………………………………...33

4. Recommended Determinations and Mitigation Actions………………….34

4.1 Categorical Exclusions……………………………………………….34

4.2 Negative Determinations with Conditions…………………………...35

5. Monitoring and Reporting………………………………………………….42

ANNEXES:

Annex 1: Environmental Screening Form ………………………………………….44 Annex 2: Healthcare Waste Management for Small Scale Facilities: Minimal

Program Checklist and Action Plan……………………………………...53 Annex 3: Disposal and Treatment Methods Suitable for Different Categories of

Health Care Waste………………………………………………………..56 Annex 4: Guidelines and Checklist for Small Scale Renovation/rehabilitation

Activities Annex 5: Additional Guidance for Installation of “Park Homes”………………….67

INITIAL ENVIRONMENTAL EXAMINATION (IEE)

FUNCTIONAL OBJECTIVE: INVESTING IN PEOPLE

PROGRAM AREA: HEALTH

Program Number: 674-008 Country: South Africa Functional Objective: Investing in People Program Area: Health Program Elements: HIV/AIDS; Tuberculosis (TB); Maternal and Child Health

(MCH); Family Planning and Reproductive Health (FP/RH) Funding Period: FY09-FY13 Authorized Funding Level: $765 million

IEE Prepared By: Charles Mandivenyi, Mission Environmental Officer (MEO), USAID/Southern Africa; and Susan Wofsy EGAT/NRM

Current Date: September 23, 2008

IEE Amendment (Y/N): Y Original IEE: June 6, 2004;

Previous Amendment: July 14, 2007 Additional references:

ENVIRONMENTAL DETERMINATION RECOMMENDED

Categorical Exclusion: X Negative Determination: X Positive Determination: Deferral:

ADDITIONAL ELEMENTS

CONDITIONS: X PVO/NGO __X__

SUMMARY OF FINDINGS

This IEE addresses USAID/Southern Africa’s Health Program (Functional Objective “Investing in People”, Program Area “Health”) with HIV/AIDS funding under the President’s Emergency Plan for AIDS Relief (PEPFAR). The current health strategy covers the Program Elements HIV/AIDS, Tuberculosis (TB), Maternal and Child Health (MCH), and Family Planning and Reproductive Health (FP/RH) within an integrated approach to health systems strengthening in South Africa. USAID/SA expects its health strategy to contribute to the use of HIV/AIDS and other PHC services, which will significantly contribute to the reduced impact of the disease in South Africa.

The Health Program has an authorized funding level estimated at $765,000,000 for FY 2009.

This estimate is based on the existing funding level of $765,000,000 which was authorized on May 16, 2006 to accommodate the influx of PEPFAR funds through FY 2008. A consistent level of funding is expected for FY 2009. However, with the reauthorization of PEPFAR on July, 30, 2008 in which the US government (USG) agreed to provide $48 billion from 2009- 2013 to combat HIV/AIDS, there is a possibility that the authorized level of funding for PEPFAR focus countries, including South Africa, may increase if approved by the Office of the Global AIDS Coordinator (OGAC). An amendment to this IEE will be submitted if there are further changes in level of funding or a shift in the health strategy.

This IEE replaces the former SO 8 “Increased Use of HIV/AIDS and Other PHC Services” IEE which ends September 30, 2008. Specifically, this amendment extends the former SO 8 IEE through September 30, 2013. Changes reflected in this amended IEE beyond the extension include alignment with the Foreign Assistance Framework and additional considerations for procurement and management of public health commodities, not previously considered as separate from medical waste. This IEE also includes the installation of “park homes” as an activity under small-scale construction or rehabilitation of health care facilities.

The most restrictive determination for the sum of the activities proposed under the Health Program Area is a Negative Determination, per 22 CFR 216.3 (a)(2)(iii), with conditions, indicating that the proposed actions will not have a significant effect on the environment, but that mitigating actions should be taken. The conditions are summarized in Table 3 for each category of activities anticipated under the Health Program.

THRESHOLD ENVIRONMENTAL DETERMINATIONS

Recommended threshold determinations for activities under this program are summarized below.

1. 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;

• Voluntary Counseling and Testing (VCT) activities, except those that generate medical and biohazardous materials;

• 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;

• 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), etc;

• 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.

2. 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 negative impact 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 Determination1.

I) Procurement and Management of Public Health Commodities:

a) For Health Program-supported activities involving procurement, storage, management and/or disposal of public health commodities, including pharmaceutical drugs, immunizations and nutritional supplements, 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 manage and dispose of such commodities.

b) 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. If disposal of any of these pharmaceutical drugs is required, due to expiration date or any other reason, the consignee will be advised

1 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.

that the preferred method of disposal is to return to the manufacturer. If this is not possible (for example if the expired or spoiled pharmaceuticals are considered hazardous and as such, if transferred across frontiers, become regulated and subject to the Basel Convention an the transfrontier shipment of hazardous wastes) then follow the guidelines in the WHO document Guidelines for Safe Disposal of Unwanted Pharmaceuticals During and After Emergencies, found at www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf.

c) At the request of the Mission, subject to available funding, the implementing partner will make all reasonable attempts to facilitate the disposal of expired drugs under this activity to mitigate the impact of medical waste.

d) 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.

e) Commodities that, during use, become hazardous or highly hazardous waste are managed under the conditions in the following section “Activities that involve the collection, safe handling and disposal of hazardous and highly hazardous medical waste.”

f) Packaging and disposal of all other public health commodities will be treated using the guidelines provided in Environmental Guidelines for Small-Scale Activities in Africa (EGSSAA) 2nd Edition, Chapter 15: Solid Waste (http://www.encapafrica.org/EGSSAA/Word_English/solidwaste.doc)

The following are illustrative activities being implemented under the Health Program that need to ensure proper management and disposal of health care commodities:

• Support for purchase and use of ARV drugs, TB drugs, and other drugs for the treatment of sexually-transmitted infections (STIs); and

• Support for purchase of drugs for immunization and vaccinations.

II) Medical Waste Handling and Management:

a) 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. Appropriate guidance is articulated in Part II, Chapter 9 of the USAID Bureau for Africa’s Environmental Guidelines for Small Scale Activities in Africa, titled, ‘Healthcare Waste: Generation, Handling, Treatment and Disposal.’ It contains guidance which should inform the Health Program activities to promote proper handling and disposal of medical waste, particularly for small facilities. See the section titled, “Minimum elements of a complete waste management program.” The URL to consult is:

http://www.encapafrica.org/SmallScaleGuidelines.htm. Other important references to consult in establishing a waste management program are “WHO’s Safe Management of Wastes from Healthcare Activities” http://www.who.int/water_sanitation_health/medicalwaste/wastemanag/en/.

b) Ensure that a medical waste management program is developed and implemented at the relevant facilities supported by USAID. As appropriate, the Health Program should use the guidance in Annex 2 for Healthcare Waste Management for Small- Scale Facilities to ensure proper waste management at Health Program-supported facilities.

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

d) 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).

e) Ensure that blood safety issues are incorporated into the training and technical assistance for USAID-supported activities, where appropriate, especially for health workers whose work may expose them to blood and other body fluids.

f) 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.

g) Promote clinical guidelines used by providers that include specific measures to deal with bio-hazardous waste.

h) 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.

i) 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.

need to ensure proper disposal:

• 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 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.

The Republic of South Africa (RSA) has medical waste disposal regulations, which are described in Section 2.2. 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. This mitigation measure is pro-active in nature and designed to further support South Africa’s application of its procedures.

III) Small- scale Construction and Renovation Activities:

a) All construction activities will be conducted following principles for environmentally sound construction, as provided in Chapter 3: Small Scale Construction of the USAID Environmental Guidelines for Small-scale Activities in Africa, which can be found at www.encapafrica.org.

b) 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, 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 for Small-scale Activities in Africa, which can be found at www.encapafrica.org.

c) For the construction of any facilities in which the total surface area disturbed exceeds 10,000 square feet (about 1,000 square meters), the program will conduct a supplemental environmental review according to guidance in Annex G of the Africa Bureau Environmental Procedures Training Manual (EPTM). Construction may not begin until such a review is completed and approved by the Mission Environmental Officer or the REO, as necessary.

d) 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 Health Team leader for proper decisions.

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

f) Construction will not require the use of any heavy equipment, or in the unlikely event it does, proper safeguards will be taken to prevent destruction of vegetation and soil erosion (e.g., runoff from the construction site which may be high in suspended solids or which may cause disruption to local drainage patterns will be monitored by the responsible implementing partner site supervisor and will be addressed);

g) 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 a 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;

h) Measures will be taken to minimize standing water;

i) No pesticides will be used without amendment of this IEE to include a pesticide analysis per 22 CFR 216.3(b)(1);

j) 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; and

k) 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.

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.

Consequently, the Health Program will ensure compliance with the guidance and checklists provided in Annex 4.

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

a) Given that the nature of the activities to be funded under sub-grants are not now known and the details about the proposed activities are not yet fully developed, e.g. siting, the grantee or sub-grantee will be required to undertake to an environmental screening process intended to identify potential environmental problems and appropriate mitigation measures, and to trigger supplemental environmental review if appropriate.

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

Environmental Screening Process:

c) Implementing partners will screen proposed activities according to the Africa

Bureau Screening and Environmental Review Process, which is described in the Bureau’s Environmental Procedures Training Manual, “Annex G: Umbrella IEEs and Subgrant Environmental Screening2,” as well as in the Africa Bureau Environmental Guidelines, Part III. Both can be found at http://www.encapafrica.org/Resources.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, 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.

2 Click on: http://www.encapafrica.org/EPTM/annex_G.pdf

e) The implementing partners will take into consideration potential environmental impacts and their mitigation and monitoring measures, including avoidance, through design, implementation, impact mitigation and monitoring of their activities 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 Africa3 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 1.

V) Clinical or Operational Research

a) For any 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.

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

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.

Caveat:

This IEE does not address construction or water and sanitation-related health activities or use of pesticides, support for which would require amendment of this IEE.

SUMMARY OF MONITORING AND REPORTING MEASURES

1. The Health Team Leader, in consultation with Mission CTOs, activity managers and implementing partners, Mission Environmental Officers (MEO), Regional Environmental Advisors (REA), and/or Bureau Environmental Officers (BEO) as appropriate, will actively monitor and evaluate whether environmental consequences unforeseen under activities covered by this IEE arise during implementation, and modify or end activities as appropriate. If additional activities are added at the Program Area level that are not described in this document, an amended IEE must be prepared.

2. Health Program procurements should include consideration of the offeror’s ability to perform the mandatory environmental compliance requirements as envisioned. The Contract/Grant Officer (CO) shall include required environmental compliance and reporting language into each implementation instrument, and ensure that appropriate resources (budget), qualified staff, equipment, and reporting procedures are dedicated to this portion of the project.

3. Health Program implementing partners will complete an annual environmental mitigation and monitoring report of all activities unless specified otherwise. This reporting should be incorporated into pertinent Performance Monitoring and Evaluation Plans and annual work plans. The environmental monitoring report should be submitted to the CTO or activity manager by the end of September each year. The CTO or activity manager will compile these reports into an overall Health Program Area report so that the results can be included in the Operational Plan (OP) reporting process to Congress.

4. For all Health Program activities entailing service delivery, including blood testing and laboratory support, implementing partners are required to complete the Healthcare Waste Management Minimum Program Checklist and Action Plan (Annex 2) annually.

5. Any grants or fund transfers from the implementing partners to other organizations must incorporate provisions stipulating that:

a) an annual environmental monitoring report will be completed, and

b) activities to be undertaken will be within the scope of the environmental determinations and recommendations of this IEE. This includes assurance that any mitigating measures required for those activities be followed.

6. The Health Team Leader, CTOs and activity mangers will undertake field visits and consultations with implementing partners to jointly assess the environmental impacts of ongoing activities, and associated mitigation and monitoring conditions.

7. The implementers’ periodic reports to USAID will include a brief update on mitigation and monitoring measures being implemented, results of environmental monitoring, and any other major modifications/revisions in the development activities, and mitigation and monitoring procedures.

8. The Health Team will ensure that implementing partners have sufficient capacity to complete the environmental screening process and to implement mitigation and monitoring measures.

9. Implementation will in all cases adhere to applicable host country environmental laws and policies.

APPROVAL OF ENVIRONMENTAL ACTION RECOMMENDED:

Recommended By: _______ Carleene Dei, Mission Director Date

Concurrence: _______ Brian Hirsch, Africa Bureau Environmental Officer Date

Approved:

Disapproved:

File No: __________________________

ADDITIONAL CLEARANCES:

Mission Environmental Officer: Date: _________ Charles Mandivenyi, USAID/Southern Africa

Health Team Leader: Date: _________ Roxana Rogers, USAID/Southern Africa

Regional Environmental Advisor: Date: _________ Camilien Saint-Cyr, USAID/Southern Africa

OPTIONAL CLEARANCE:

Regional Legal Advisor (Southern Africa) ______________________ Date: _________ Donald Keene

General Counsel (Africa Bureau) ___________________________ Date: _________

Tanya Nunn

ANNEXES AT END:

Annex 1: Environmental Screening Form Annex 2. Healthcare Waste Management for Small-Scale Facilities: Minimal Program

Checklist & Action Plan Annex 3. Disposal and Treatment Methods Suitable for Different Categories of Healthcare

Waste Annex 4. Checklist for Small-scale Construction and Renovation Activities Annex 5: Additional Guidance for Installation of “Park Homes”

ACRONYM LIST

ABC Abstinence, Be Faithful, Use a Condom ADS Automated Directive Systems ANC Antenatal Care ARV, ART Anti-retroviral (therapy, treatment) CBO Community-Based Organization CDC U.S. Centers for Disease Control and Prevention CTO USAID Cognizant Technical Officer DOH National Department of Health (South Africa) DOTS Directly Observed Therapy, Short Course (strategy for therapy of TB) DSD Department of Social Development EGSSA USAID Environmental Guidelines for Small-Scale Activities in Africa EMMR Environmental Mitigation and Monitoring Report EPI Expanded Program on Immunization EPTM Environmental Procedures Training Manual FBO Faith-Based Organization HBC Home-Based Care HCW Health Care Waste HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency

Syndrome IEC Information, Education, Communication IEE Initial Environmental Examination IMCI Integrated Management of Childhood Illness MCH Maternal and Child Health MECs Members of Provincial Executive Councils MEO Mission Environmental Officer NGO Non-Governmental Organization NHLS National Health Laboratory Services NIH U.S. National Institutes of Health NVP Nevirapine OGAC Office of the Global AIDS Coordinator OI Opportunistic Infection OVC Orphans and Vulnerable Children OVH Orphans and Vulnerable Households PEPFAR President’s Emergency Plan for AIDS Relief PHC Primary Health Care PLWHA People Living with HIV/AIDS PMTCT Prevention of mother-to-child transmission QA Quality Assurance RH/FP Reproductive Health/ Family Planning RHAP Regional HIV/AIDS Program RTKs Rapid Test Kits STI Sexually Transmitted Infection TB Tuberculosis UNAIDS United Nations AIDS Program USAID United States Agency for International Development VCT Voluntary HIV Counseling and Testing WHO World Health Organization

INITIAL ENVIRONMENTAL EXAMINATION (PIEE)

FUNCTIONAL OBJECTIVE: INVESTING IN PEOPLE

PROGRAM AREA: HEALTH

Program Number: 674-008 Country: South Africa Functional Objective: Investing in People Program Area: Health Program Elements: HIV/AIDS; Tuberculosis (TB); Maternal and Child Health

(MCH); Family Planning and Reproductive Health (FP/RH) Funding Period: FY09-FY13 Authorized Funding Level: $765 million

IEE Prepared By: Charles Mandivenyi, Mission Environmental Officer (MEO), USAID/Southern Africa; and Susan Wofsy EGAT/NRM

Current Date: September 23, 2008

IEE Amendment (Y/N): Y Original IEE: June 6, 2004;

Previous Amendment: July 14, 2007 Additional references:

ENVIRONMENTAL DETERMINATION RECOMMENDED

Categorical Exclusion: X Negative Determination: X Positive Determination: Deferral:

ADDITIONAL ELEMENTS

CONDITIONS: X PVO/NGO __X__

SECTION 1: Background and Project Description

1.1 Purpose and Scope of IEE

The purpose of this IEE is to review USAID/Southern Africa activities implemented in South Africa under the Functional Objective “Investing in People”, Program Area “Health” (Health Program) with HIV/AIDS funding under the President’s Emergency Plan for AIDS Relief (PEPFAR) and provide threshold determinations of environmental impact and conditions for mitigation. This IEE supersedes the former SO 8 “Increased Use of HIV/AIDS and Other PHC Services” IEE which ends September 30, 2008. Specifically, this amendment extends the former SO 8 IEE. Changes reflected in this IEE beyond the extension include alignment with the Foreign Assistance Framework and additional considerations for procurement and management of public health commodities, not previously considered as separate from medical waste. This IEE also includes the installation of “park homes” as an activity under small-scale construction or rehabilitation of health care facilities. This IEE does not address water and sanitation-related health activities or use of pesticides, support for which would require amendment of this IEE.

The former IEE covers activities funded through FY 2008 and implemented by SO8 (now referred to as the Health Program) under PEPFAR through FY 2009. This IEE covers all Health Program activities funded from FY 2009 through FY 2013.

The current Health Program reflects only a minor revision of SO 8; however, activities are increasingly focused on partnership development and transfer of responsibility to the Government of South Africa. Health Program activities implemented with HIV/AIDS funding under PEPFAR fall under the areas of HIV/AIDS prevention, treatment, care and support, and support services for orphans and vulnerable children (OVCs). The Health Program authorized level of funding for FY 2009 is estimated at $765 million. This estimate is based on the existing funding level of $765,000,000 which was authorized on May 16, 2006 to accommodate the influx of PEPFAR funds through FY 2008. With the reauthorization of PEPFAR on July, 30, 2008 in which the US government (USG) agreed to provide $48 billion from 2009-2013 to combat HIV/AIDS, there is a possibility that the authorized level of funding for PEPFAR focus countries, including South Africa, may increase if approved by the Office of the Global AIDS Coordinator (OGAC). An amendment to this IEE will be submitted if there are further changes in level of funding or a shift in the health strategy.

If additional activities not covered by this document are proposed under the Health Program, an Environmental Screening Form found in Annex 1 will be completed by the CTO and/or the implementing partner and submitted to the MEO to ensure that the activities and conditions in this IEE still apply. In the event that any new proposed activity differs substantially from the type or nature of activities described here, or requires different or additional mitigation measures beyond those described, this IEE will be amended.

1.2 Overview of USAID/SA Health Program

USAID’s Health Program in South Africa is implemented in concert with the NDOH and is in alignment with the Strategic Plan and the Comprehensive Plan. In 2000, the SAG released the South African National HIV/AIDS and STI Strategic Plan, 2000-2005 (Strategic Plan), which called for an expanded response, including primary prevention, Prevention of Mother-to-Child Transmission of HIV (PMTCT), treatment and care. Strengthening HIV and AIDS services was called for within the context of NDOH efforts to strengthen the public heath system as a whole and the SAG’s core principles of “access, equity, efficiency, quality and sustainability.” The Strategic Plan was followed by the 2003 Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa, April 2004-March 2009 (the Comprehensive Plan), which details a national program to provide a continuum of care, including AIDS treatment using anti-retroviral therapy (ART), provided in district-focused service networks. In June 2007, the SAG approved the “HIV and AIDS and STI Strategic Plan for South Africa, 2007-2011.” These three documents mandate a balanced, comprehensive program organized into four key areas of intervention: (1) prevention; (2) treatment, care and support; (3) research, monitoring and surveillance; and (4) legal and human rights. They call for integration of public and private sector resources, community participation, involvement of People Living with HIV/AIDS (PLWHA), and incorporation of traditional medical practitioners. They also emphasize the synergistic benefits expected from integrating prevention, treatment and care. Together, these documents provide the policy framework within which the USAID/SA Health Program operates.

While HIV/AIDS constitutes the bulk of the health portfolio, the Health Program continues to provide assistance in enhancing the delivery of primary health care services under the following four Program Elements through several follow-on agreements to its highly successful health systems strengthening project (Equity) which concluded in 2004. In accordance with the Foreign Assistance Framework, they are:

3.1.1 HIV/AIDS

3.1.2 Tuberculosis (TB)

3.1.6 Maternal and Child Health (MCH)

3.1.7 Family Planning and Reproductive Health (FP/RH)

The follow-on primary health care project provides technical assistance at the national government level and in five provinces to improve primary health care services. The focus is on strengthening district and community health care facilities by building-up a cadre of trained and capable health care workers.

Gender integration is a 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. Increasing male involvement in HIV prevention, treatment and care is also a key part of the USAID health program. Given the multi-faceted impact of the epidemic, the Health Program will continue to be multi-sectoral. The elements of USAID’s multi-sectoral approach are based on linkages between all Functional Objectives of the Mission.

Program Element 3.1.1 HIV/AIDS

In the prevention area, USAID assists government efforts to: (1) promote the Abstinence, Be faithful, and always use a Condom (ABC) message through mass and community based communication activities; (2) continue the provision of technical support for condom and PMTCT initiatives; and, (3) address the challenges of stigma and discrimination for those infected and affected by HIV/AIDS.

In the area of treatment and care, USAID assistance will support the government’s goal of providing quality ART services through accredited public sector facilities to one million people in 2009. USAID partners are providing a wide variety of care and treatment assistance in support of the implementation of the SAG’s Comprehensive Plan, including: 1) provision of trained doctors, nurses, and lay counselors to augment staff at facilities in the direct delivery of ART services; 2) community-based, mobile clinic and facility-based voluntary counselling and testing (VCT) services; 3) provision of community-based workers including patient advocates, support group mentors, psycho-social counselors, male involvement advocates and other outreach workers (these workers may also be provided by NGOs to assist SAG rollout facilities); 4) technical assistance to improve referral from home-based care programs for ART; 5) technical assistance for support systems such as information systems, logistics systems, pharmaceutical systems, laboratories, and quality assurance; and 6) support for “wellness” programs that track positive clients post testing, treat for opportunistic infections including TB, and provide information and social support prior to eligibility for treatment.

In collaboration with the South African Department of Social Development (DSD), USAID supports a variety of comprehensive, community-based programs to assist children infected and affected by HIV/AIDS including nutritional, psychosocial and emotional support, bereavement, and assistance in accessing government grants.

HIV/AIDS activities financed through the Health Program will cover the following Sub-

Elements:

• Preventing Mother-to-Child Transmission (PMTCT)

• Abstinence/Be Faithful

• Medical Transmission/Blood Safety

• Medical Transmission/Injection Safety

• Condoms and Other Prevention Activities

• Palliative Care: Basic Health Care and Support

• Palliative Care: TB/HIV

• Orphans and Vulnerable Children (OVC)

• Counseling and Testing

• HIV/AIDS Treatment/ARV Drugs

• HIV/AIDS Treatment/ARV Services

• Laboratory Infrastructure

• Other/Policy Analysis and System Strengthening

• Host Country Strategic Information Capacity

• Program Design and Learning

• Administration and Oversight

Program Element 3.1.2 Tuberculosis

The USG’s ongoing TB program in South Africa supports 1) expansion and enhancement of the Directly Observed Treatment Short-course (DOTS); 2) management of TB and HIV; 3) provision of TB care and support; and 4) combating multi-drug resistant TB (MDR TB). The Health Program works with provincial and district health departments in five provinces to ensure adherence to national guidelines and to create service delivery models for rapid DOTS expansion and surveillance of drug resistant TB. At the national level, the USG is helping to integrate TB with HIV and other health services through functional systems that promote HIV counseling and testing to all TB patients, and screening for TB with all HIV-infected clients. To reduce treatment interruption rates and improve adherence, the USG is helping to build partnerships between health centers and community organizations supporting DOTS.

TB activities financed through the Health Program will cover the following Sub-Elements:

• DOTS Expansion and Enhancement

• Care and Support

Program Element 3.1.6 Maternal and Child Health & Program Element 3.1.7 Reproductive Health/ Family Planning

The Health Team supports several initiatives which provide overarching assistance across program elements in strengthening the primary health care systems and services including Maternal and Child Health (MCH) and Reproductive Health/Family Planning (RH/FP), within a comprehensive PHC package. Health program support for PCH services is on capacity building, sustainability, quality of care and integration at the district level in the five most disadvantaged provinces. The objectives are to: 1) strengthen key elements of the primary health care of the DHS (e.g., drug and commodity management, quality of care, management, supervision, information use, monitoring and evaluation); 2) build effective health management capacity and systems at the district health level (e.g., training to develop capable district health teams), municipal level, and national level; 3) integrate key HIV/AIDS prevention activities into the primary health care system (e.g., ANC, VCT, PMTCT, STI treatment, TB detection and treatment, management of opportunistic infections, and dual protection counselling); 4) support the provision of a comprehensive PMTCT package with broader access to high quality reproductive and other health services including antenatal care, nutrition, Vitamin A, treatment of opportunistic infections, treatment of STIs, TB screening and other measures which strengthen women’s health; 5) strengthen the capacity of community networks to manage their health status (e.g., support for pregnant mothers, immunization education, nutrition education, reduction in stigma, care and support within the community for vulnerable groups and training for hospital and clinic committees); and 6) leverage effective public private partnerships at the community level.

The Health Program is assisting the national and provincial DOH to strengthen the systems associated with the delivery of services, rather than in the actual delivery of services, through either non-governmental organization (NGO) and/or public facilities (e.g., logistics, management information systems, supervision systems). USAID will also assist in improving the quality of these services.

MCH activities financed through the Health Program will cover the following Sub-Element:

• Administration and Oversight

RH/FP activities financed through the Health Program will cover the following Sub-Element:

• Service Delivery

1.3 Implementation and Management Approach of USAID/SA Health Program

USAID’s comparative advantage in South Africa lies in assisting the national and provincial Departments of Health to strengthen the systems associated with the delivery of services, rather than in the actual delivery of services, through either non-governmental organization (NGO) and/or public facilities (e.g., logistics, management information systems, supervision systems, construction of rehabilitation of health care facilities). All activities undertaken pursuant to the achievement of the Health Program will be carried out by local and U.S. non-governmental organizations, public organizations or other entities, including private sector firms, Faith-Based Organizations (FBOs), foundations and other non-traditional partners, selected by USAID and financed through grants, contracts, cooperative agreements or Implementation Letters. USAID will provide the technical and administrative personnel required to finance and oversee the implementation of these activities.

Historically, the Health Team has obligated all health and HIV/AIDS funds through either the health Grant Agreement or by direct obligation to USAID cooperating agencies that are providing services requested by the SAG. This will continue to be the case, even for HIV/AIDS funding received by the Agency through PEPFAR. Under PEPFAR, implementation of HIV/AIDS activities will be planned annually based on (1) country budget levels established by the Office of the U.S. Global AIDS Coordinator (OGAC), (2) SAG priorities and needs, (3) consistency with USAID’s approved Operational Plan, and (4) approval by OGAC of specific activities submitted through Country Operational Plans each

September. Implementation of the PHC and TB components of USAID’s health portfolio will also be guided by the decisions of the Strategic Coordinating Committee, which is chaired by the NDOH and includes USAID and implementing partner representation. All USAID-supported health projects, regardless of funding source, will continue to be approved by the appropriate SAG authority (e.g. province or district) prior to initiating any activities.

In implementing PEPFAR in South Africa, new partners have been solicited, reviewed and approved through a transparent competitive process involving representatives of USAID, the Embassy, the U.S. Centers for Disease Control and Prevention (CDC) and the SAG. To facilitate the management of USAID’s expanding Health and HIV/AIDS portfolio, the Health Program will use umbrella grants management and technical assistance agreements to handle a large number of HIV/AIDS partners.