The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) Appraisal Environmental and Social Review Summary Appraisal Stage (ESRS Appraisal Stage) Public Disclosure Date Prepared/Updated: 05/06/2022 | Report No: ESRSA02198 May 06, 2022 Page 1 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) BASIC INFORMATION A. Basic Project Data Country Region Project ID Parent Project ID (if any) Brazil LATIN AMERICA AND P176796 CARIBBEAN Project Name BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT Practice Area (Lead) Financing Instrument Estimated Appraisal Date Estimated Board Date Health, Nutrition & Investment Project 4/18/2022 5/26/2022 Population Financing Borrower(s) Implementing Agency(ies) Ministry of Finance Ministry of Health Proposed Development Objective To increase COVID-19 vaccination coverage among the population of Brazil. Public Disclosure Financing (in USD Million) Amount Total Project Cost 600.00 B. Is the project being prepared in a Situation of Urgent Need of Assistance or Capacity Constraints, as per Bank IPF Policy, para. 12? No C. Summary Description of Proposed Project [including overview of Country, Sectoral & Institutional Contexts and Relationship to CPF] The proposed World Bank’s US$600 million Project would provide financing and technical assistance to the Government of Brazil (GoB) to support the health sector’s response to the challenges imposed by the COVID-19 pandemic. The Project would finance about 9 percent of all vaccines contracted by GoB since the start of the pandemic, for vaccine deliveries in 2022. Specifically, the Project will support the acceleration of the COVID-19 vaccine rollout to contain the spread of the disease and COVID-19-related deaths. D. Environmental and Social Overview May 06, 2022 Page 2 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) D.1. Detailed project location(s) and salient physical characteristics relevant to the E&S assessment [geographic, environmental, social] Brazil is one of the countries most affected by the COVID-19 pandemic in the world with 660,973 registered COVID-19 related deaths (the 2nd highest in the world, representing 10% of total world deaths) by April 7, 2022, a ratio of 3,099 casualties per million people (the 14th highest in the world), and 30,093,751 recorded infections (3rd in the world, 6% of world total). Although most of the states and larger municipalities implemented social distancing measures to contain the spread of the virus by the end of March 2020, these measures were unevenly enforced and adhered to. The Covid-19 pandemic has disproportionately affected the poor and vulnerable groups. The poor (24.7% of the population, before the pandemic and assuming a poverty line of US$ 5.5 PPP a day) are more likely to be employed in face-to-face sectors and this has put them at higher risk of contracting COVID-19. Workers in low-skilled face-to-face sectors represent the largest share of the reported COVID-19 fatalities in Brazil. Vulnerable people with no schooling at the lower end of the income distribution had represented 14% of all COVID-19 deaths in 2021. Climate-vulnerable groups in urban favelas and in the Northeast and North regions of the country (where poverty rates peak at 42.9% and 41.6% respectively were also among the most exposed to Covid-19 risks. The poorest, most crowded urban areas in the Southeast region (such as São Paulo and Rio de Janeiro) have been the first to be hit by COVID-19 and rank 1st in the cumulative number of cases. In these cities, vulnerable groups living in in the poorest neighborhoods and irregular settlements were more likely to die compared to patients living in the 5 percent wealthiest areas. Afro- Brazilians (among whom poverty rates reached 32.3% before the pandemic) and women have been disproportionately affected by the pandemic in terms of higher unemployment incidence and loss of income. Because of the pandemic, more family members stayed at home, women’s household chores significantly increased and their participation in the labor force participation felt from 66% to 62% since the onset of the pandemic; women’s Public Disclosure subjective well-being has decreased and gender-based violence (GBV) has increased during the pandemic. Due to historical exclusion and immunological and socioeconomic factors, indigenous Peoples (count for just 0.43% of the country’s population, but are found in 7,103 localities spread over 827 municipalities, mostly located in the Northern and Northeast regions) were also particularly vulnerable to COVID-19 and its serious consequences, with mortality rates two times higher than the rest of the population. The poor and vulnerable population heavily relies on the National Unified Health System (Sistema Único de Saúde, SUS) as their main source of health care. SUS serves more than 70% of the Brazilian population (approximately 160 million people). Virtually all the poor and vulnerable population (bottom 40% of the distribution) rely exclusively on the SUS to access health services, a ratio that diminishes substantially for the upper income deciles. Among citizens using exclusively SUS for primary health care, 54% do not have a job occupation and 65% earn less than a minimum wage. The Brazilian National Plan of Operationalization of Vaccination against Covid-19 is integrated in the National Immunization Program (PNI), which was established in 1973 as part of SUS, coordinated by the MoH and implemented by states and municipalities. This Vaccination Plan has defined priority groups for COVID-19 vaccination (to be vaccinated before it was open to the rest of the adult population) in accordance with the WHO, the Strategic Advisory Group of Experts on Immunization (SAGE) values framework and vulnerability to the disease. The priority groups counted for 38% of the total population, around 80.5 million people) and included health workers, persons with comorbidity, education workers, and vulnerable population groups – the elderly, Indigenous Peoples, quilombolas (1.18 million people spread over 5,972 localities in 1,672 municipalities), riverine populations (nearly 633,000 people), the homeless population (nearly 141,000 people), and people with disabilities (around 8.8 million people). After a slow start in early 2021 due to supply side constraints, the vaccination pace accelerated starting in June 2021. Nowadays, vaccine contracts for over 669 million doses have been negotiated (with 581 million of them already May 06, 2022 Page 3 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) delivered to the country) and free of cost vaccination is being provided to all population above 5 years of age, including nationals and non-nationals. Brazil is also applying a booster dose after 4 months of the second dose as recommended for protecting from more recent variants like Delta and Omicrom. By April 7, 2022: 420 million doses have been delivered; 82.7% of the population have received first doses; 75.8% second doses; but only 38.2% got booster doses. Vaccine hesitancy is low in Brazil: back in March, 2021 when vaccination started, around 85 percent of the population indicated willingness to be vaccinated against COVID-19. There are, however, some regional differences that are relevant for the implementation of the Project. The provision of public health services by SUS is more constrained in the poorest North and Northeast regions than in the rest of the country. Considering the critical role of communication in the response to Covid-19, the large gaps in access and use of the internet between urban (86.7%) and rural (55.6%) areas (the lower rates of access found in rural areas of the Northern and Northeastern regions – 38.4% and 51.9%, respectively) has also to be highlighted. Assessing regional inequalities in the pace of implementation of vaccination, three main reasons have been pointed out by the health authorities at the federal and state level. They are: first and foremost, differences in the sociodemographic profile of the regional populations; second differences in early access to information on vaccination leading different ratings of hesitancy to take the vaccine; and third, the split between rural and urban areas that have early created logistic challenges. Thus, vaccination early lagged behind in the North region as the regional population is younger than in the rest of the country and, consequently, less people were included in the early stage of the vaccination campaign focused on the priority groups (largely composed by the elderly). Hesitancy was initially also higher in this region and in its more remote locations. This situation has been addressed by enhancing communication and outreach strategies and these regional gaps are steadily shrinking. Regional differences are also reflected in the environmental management conditions and enforcement of the federal Public Disclosure environmental legislation, e.g. the National Solid Waste Policy (NSWP) and need to be considered in the Project’s Environmental and Social Management Framework. D. 2. Borrower’s Institutional Capacity The project will support the implementation of Brazil’s National Plan of Operationalization of Vaccination against Covid-19 as part of MoH’s response and pandemic preparedness led by its Executive Secretariat. The Project will finance the purchase of vaccines against COVID-19 and will include Retroactive Financing (that may be up to 60 percent) of vaccines acquired by the Brazilian Government from Pfizer, in 2022. Project implementation will be also supported by the Special Secretariat, created in May 2021, to respond to the COVID-19 pandemic, in partnership with other secretariats within MoH and under the oversight of the Executive Secretariat. Given the characteristics of the SUS, the pandemic scenario, and the activities expected to be financed under this operation, the Health Surveillance Secretariat (Secretaria de Vigilância em Saúde, SVS) will also be involved in Project implementation. The proposed institutional arrangement envisages the utilization of MoH’s organizational structure, which includes the Indigenous Peoples Care Secretariat (SESAI) and OUVSuS (the ministry’s ombudsman office). MoH’s Executive Secretariat will provide specialized technical, fiduciary and environmental and social risk management services deemed necessary for the Project’s proper implementation and supervision. Within 30 days of Project effectiveness, MoH’s Executive Secretariat will appoint a social specialist and an environmental specialist (with background in medical services OHS) to be responsible for management and monitoring of Project environmental, social, health and safety (ESHS) performance. Special emphasis will be placed on the (a) monitoring of the inclusion of marginal and vulnerable social groups, (b) biomedical waste management, and (c) feedback loops to solicit feedback and grievances from the beneficiaries. MoH has experience with investment projects financed by the World Bank, which have helped to implement the main reforms of the Unified Health System (SUS) over the past decades, both at the federal and at sub-national levels. Projects such as Family Health Extension (P057665, Bolsa Familia 1st APL (P087713) and Second Bolsa Familia May 06, 2022 Page 4 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) (P101504) helped to establish and expand the family health program (Programa de Saúde da Familia, PSF) in Brazilian municipalities with more than 100,000 inhabitants. The AIDS-SUS Project (P113540) helped to consolidate one of the pioneering programs for the treatment and control of HIV/AIDS infection in Brazil. The Health Network Formation and Quality Improvement Project (QUALISUS-Rede, P088716) sought to implement health care networks through subprojects all over the country. More recently, the World Bank provided technical assistance to the MoH in the design of the primary health care financing reform, which will be implemented with the support of the proposed Program. However, MoH has no previous experience with the World Bank’s Environmental and Social Framework (ESF) and its Environmental and Social Standards. To carry out key environmental and social assessment functions and implement the project to meet the objectives of the ESSs, including Good International Industry Practice (GIIP)The Executive Secretariat will require intensive implementation support and a continuous dialogue with the client. The Bank’s Environmental and Social specialists will work closely with the Borrower’s team providing guidance for the preparation of the E&S risk management tools: ESMF – including the relevant aspects of an umbrella IPC&WMP, LMP and final SEP, which shall be disclosed no later than 60 days after project effectiveness. Furthermore, training and hands-on support will be required on a technical level in terms of environmental and social risk management to the Executive Secretariat. This will include supporting the Executive Secretariat in the identification and mitigation of social and environmental risks. MoH will allocate funds for supporting the implementation of the environmental and social risk management measures agreed in the Environmental and Social Commitment Plan (ESCP). It is worth to highlight that: • Brazil has comprehensive regulations on occupational health and safety (OHS), including specific provisions relating to health workers, which may contribute to prevent and minimize the project’s potential negative impacts on Public Disclosure workers. • Broad legislation and strong enforcement institutional capacity (through the sanitary surveillance system coordinated by ANVISA – an agency under the organizational structure of MoH) on the management and disposal of waste generated by health services and, which may contribute to prevent and minimize the Project’s potential negative impacts on community and the environment. ANVISA is responsible for managing the social and environmental impacts of health services, regulates and oversees the management of health services waste, following the requirements set by the National Policy for Solid Waste (Law 12,305/2010). The ANVISA system counts with offices in more than 4,000 municipalities and a workforce composed of 24,288 staff. • SUS is based on principles of universality, equitable access to health services and social participation and control, which are critical safeguards against discrimination and prejudice against disadvantaged and vulnerable individuals and social groups and may contribute to ensure fair and equitable access to project benefits. • In response to COVID-19, MoH has carried out broad and country-wide communication campaigns on the pandemic and on the vaccine roll-out using both traditional media (TV and radio broadcasting networks, newspapers) and social media, which may contribute to minimize the potential risk that poor access to information could compromise the vaccine roll-out or generate fears and hesitancy with regards to vaccination. Thus, the latest public polls have shown that 84% of the Brazilian population want to be vaccinated (Datafolha, March 23, 2021). • SUS comprises a well-operating network of Ombudsman offices, which shows all the functionalities needed to facilitate the resolution of complaints related with Project-supported activities. • Brazil has one of the largest, well-regulated and well implemented immunization programs in the world including yearly vaccination campaigns that have being carried out for nearly 50 years, allowing that the vaccination against COVID-19 relies on this well-established capacity in terms of logistics and trained human resources, and • Brazil has succeeded to deliver 420 million doses (By April 7, 2022) without any indication of relevant indication of problems in the health, safety and environmental procedures. The Federal Government, state and May 06, 2022 Page 5 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) municipal governments implemented GRM to follow up the vaccination campaigns. The GRM records do not indicate significant problems in the Covid-19 vaccination campaign health and safety procedures. The main claims are related to people trying to get shots out of the priority list defined by the government, and delays in the vaccine registration in the national Open Data SUS database - Connect SUS. II. SUMMARY OF ENVIRONMENTAL AND SOCIAL (ES) RISKS AND IMPACTS A. Environmental and Social Risk Classification (ESRC) Moderate Environmental Risk Rating Moderate Environmental risk rating for this Project is Moderate, as Brazil has succeeded to mitigate the potential health and safety risks of the Covid-19 vaccination campaign. The procedures to prevent or minimize the spread of infectious diseases and conduct the vaccination campaign in a safe manner, detailed in the National Operationalization Plan for the Covid-19 Vaccination, have been implemented country wide, with no indication of major sanitary or environmental problems. The Project will finance the purchase of vaccines against COVID-19 by the MOH that will be distributed to the entire country. There is no need of investments to support the cold chain, Personal Protective Equipment (PPE) or other supplies for the vaccination campaign. Covid-19 is integrated in the National Immunization Program (PNI), established in 1973 as part of SUS, and object of major investments along the decades. Most vaccination is done into existing health facilities, operating in accordance to the Federal Sanitary regulations, which determines numerous occupational and health requirements, including the use of PPEs. The activities related to the COVID-19 vaccination campaign pose potential risks to health workers and support staff, notably, risk of infecting Public Disclosure workers involved in the vaccination campaigns and spreading infectious diseases to the community. Vaccination campaigns demand extensive use of sharp instruments and pharmaceuticals, produces hazardous wastes, and poses risks to the environment and society that should be properly mitigated and managed to avoid harm. However, the Project’s potential impacts and risks can be mitigated through proper sanitation, OHS and environmental procedures, as defined in the World Bank Group’s EHS Guidelines and GIIP, including technical guidance developed by WHO for addressing COVID-19. Brazil’s health system capabilities and OHS, sanitary and environmental regulatory framework are in line with the GIIP, and its implementation in the Covid-19 vaccination has been satisfactory, moderating the Project’s potential risks. Brazil has comprehensive regulations for health waste management, defining meticulous procedures for identification, segregation, storage and disposal of medical wastes, including any wastes generated by vaccinations campaigns. Brazil also has a series of OHS regulations including one for medical services (NR 04), which requires the preparation and implementation of Environmental Risk Prevention Programs, Occupational Health Medical Control Programs, vaccination and Quality Assurance Programs, and the mandatory use of PPE for health workers, including those implementing the vaccination. The enforcement of OHS regulations is done by the Federal Secretariat of Labor, a federal agency with police power. The roll-out of Covid-19 vaccines takes advantage of the countries 42,000 primary health care centers distributed across the country, noting that all health care facilities have to comply with the Federal health, safety and sanitary legislation. The challenges for implementing vaccine cold chain temperature monitoring across the country was known prior to the Covid 19 outbreak and MoH issued, in 2017, the Vaccine Cold Chain Manual to support the yearly vaccination campaigns of the PNI. The information available (based on MoH’s Grievance Mechanism and a screening exercise of news on the roll-out of the vaccination campaign in the national media) points out that there have been no issues related with no-compliance with waste management, infection control and OHS national regulations. The ESMF will include further assessments of compliance with these rules and the Project’s potential risks and impacts, and a gap analysis to verify if the country system matches the ESF May 06, 2022 Page 6 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) requirements. The ESMF shall include an ICP/WMP and may propose additional OHS and environmental requirements applicable to vaccination campaigns, including measures to ensure adequate management of health wastes and avoid/minimize OHS risks. Social Risk Rating Moderate The social risk rating is Moderate. The Project will support Brazil’s vaccination against Covid-19 efforts. Contributing to expand the coverage of the population with booster doses (now reaching just 38% of the population), the Project is expected to have positive social impacts. The National Plan of Operationalization against Covid-19 has reached relevant outcomes. So far 82.7% of the population received first doses and 75.8% second doses, with a broad territorial outreach that has encompassed all vulnerable groups, though some regional imbalances on the achievement of the objectives of the vaccination efforts as the vaccination rates range from 81.0% in the Southeast down to 57.4% in the North region. Vaccine hesitancy has been low in Brazil since the start of the vaccination campaign as around 85% of the population indicated willingness to be vaccinated. This plan has prioritized the population most at risk including vulnerable groups (the elderly, persons with comorbidities, Indigenous Peoples, quilombolas and riverine populations, the homeless and the incarcerated population, and people with disabilities), health and education workers, among others. Now, vaccination is open to the population 5 years of age and older. The envisaged social risks and adverse impacts are predictable, expected to be temporary and reversible. They can be avoided, minimized or mitigated in a predictable manner. The Project does not involve new constructions and no adverse impacts related to land acquisition or involuntary resettlement are expected. Furthermore, no adverse impacts on Indigenous Peoples are expected, who have continuously evidenced – through their most representative organizations – broad support the vaccination against Covid-19 in Brazil. They have been included among the priority group and their vaccination rate is high (according to official data, as of April 8, 2022, 91% of the indigenous Public Disclosure population aged 18 years and over assisted by SASISUS voluntarily received the 1st dose and 86% received the 2nd dose or a single dose). Despite some regional imbalances on the pace of vaccination (due to sociodemographic characteristics, early gaps on hesitancy ratings and the logistic to reach remote locations that have been addressed through the enhancement of the communication and outreach strategy), there is no evidence that individuals or social groups have been discriminated against on the basis of identity features. The successes achieved by the vaccination campaign in Brazil dispel or reduce previous expectations related with risks associated to: (a) occupational health and safety hazards and/or harsh working conditions that could be faced by health professionals working in vaccination stations (such as long working hours, psychological distress, fatigue, occupational burnout, stigmatization, sexual harassment and aggression, physical and psychological violence); (b) the eventual use of security forces for the deployment of vaccines in remotely located areas and security personnel on the surveillance of vaccinations stations; and (c) potentially inadequate behaviors – for instance: lack of understanding and respect for cultural differences, prejudice and discrimination, fraternization, SEA/SH – by Project workers during their interactions with local communities gearing up interpersonal conflicts and violence. No forced vaccination of the general adult population is in place. However, taking in consideration the size of the country and the regional disparities on access to information channels, one potential social risk that remains refers to potential unequitable access to Project benefits. The ESMF and the SEP will consider how intensely disinformation and misinformation, digital illiteracy and remote location create regional barriers to access and deny equitable benefit sharing for remotely located communities in the most backward regions of the country and propose the measures needed to avoid, reduce or mitigate this risk. B. Environment and Social Standards (ESSs) that Apply to the Activities Being Considered B.1. General Assessment May 06, 2022 Page 7 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) ESS1 Assessment and Management of Environmental and Social Risks and Impacts Overview of the relevance of the Standard for the Project: This standard is relevant. To assess, manage and monitor environmental and social risks and impacts associated with the Project, the MoH will prepare an Environmental and Social Management Framework (ESMF), a Stakeholder Engagement Plan (SEP) and Labor Management Procedures (LMP). The draft SEP will be disclosed for public consultation before appraisal; the ESMF, final SEP and LMP will be finalized and disclosed within 60 days of Project’s effectiveness. The ESMF will pay special attention to: • OHS, medical waste management, and social inclusion. The ESMF will consolidate the applicable OHS procedures for health workers and pollution prevention requirements for vaccination, observing both the Brazilian OHS and pollution prevention regulations and the relevant GIIP – notably WHO technical guidance related to COVID- 19, the WBG EHS Guidelines, and the World Bank Interim Note on COVID-19. The ESMF may propose complementary OHS measures in the case that the Brazilian system is not consistent with the ESS requirements. • Infection prevention and control and waste management procedures (IPC&WMP), verifying whether the guidance issued by the MoH’s on vaccination procedures (including OHS, use of personal protective equipment (PPE), bio-security measures, and handling medical waste) are in line with WHO guidelines and GIIP. • Verification of alignment between the guidance for planning the vaccine cold chain temperature monitoring issued by Anvisa with WHO Vaccine Management Handbook “How to Monitor Temperatures in the Vaccines Supply Chain” and proposal of additional measures, if applicable. • Potential barriers that disadvantaged and vulnerable individuals and social groups among the Brazilian population may face in accessing vaccines. These social groups encompass the elderly, people with disabilities, low- Public Disclosure income migrants and refugees; Indigenous Peoples and people located in remote and poorly provided places; and people who fear discrimination and prejudice because of their race, ethnicity, nationality, and sexual orientation, and sociodemographic groups at disproportionately higher risk of severe disease or death. These barriers are also related with the potential risk of unequal and inadequate access to trustful information about the vaccines by individuals and social groups who are remotely located, digitally excluded or illiterate, or face language constraints or some forms of prejudice and discrimination and they may hamper their ability to raise issues and concerns about the Project, or to propose measures to avoid, minimize or mitigate adverse impacts, or to have their views taken into consideration. They may also hamper fair and equitable access to Project-benefits. • Potential risks to community health, safety, and security (including SEA/SH) related with the use of security personnel and/or military forces (particularly in remote locations) and propose the measures to be taken to avoid and minimize them, including access to grievance mechanisms without risk of retaliation. • The ESMF will include a budget estimate for carrying out the E&S management measures. The ESMF shall be prepared, consulted, disclosed and adopted no later than 60 days after Project effectiveness. The ESMF will also include an environmental and social assessment of the existing hazardous waste management and OHS procedures, including the effective enforcement of the national regulation in the roll-out of the vaccination campaign across the country as well as the drivers of remaining regional imbalances on vaccination ratings. With respect to payments for vaccines purchased and deployed prior to the date of the Loan Agreement and presented for retroactive financing (that may be up to 60%), the Borrower will carry out and furnish to the Bank a Rapid E&S Assessment, acceptable to the Bank. The TORs of the Rapid E&S Assessment shall be subject to the Bank’s prior approval. At a minimum, this assessment shall consider (i) the implementation of social inclusion measures, in accordance with the prioritization schedule set out in the national vaccination and vaccine availability; (ii) the existence of proper waste management system, including medical waste and adequate treatment; (iii) the operation May 06, 2022 Page 8 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) of grievance redress mechanisms; and (iv) the protection of the workers involved (application of occupational health and safety measures and the use of protective equipment). The Rapid E&S Assessment shall also include a corrective action plan, if needed, to be implemented in accordance with its terms. The findings of the Rapid E&S Assessment shall inform the ESMF and strengthen Borrower’s capacity on E&S management. The team has assessed the Covid-19 response Plan, the Covid-19 response plan for Indigenous Peoples, the Covid-19 vaccination plan, SUS regulatory framework and National Health Policy (and in particular the Indigenous Peoples health system), the regulation on labor and OHS, solid waste management and environmental licensing for health facilities, and the functionalities of the governmental Ombudsman Offices network and the existing channels to address labor-related complaints (including complaints SEA/SH in the working places). It shall be highlighted that: • Brazil’s National Plan for Operationalization of Vaccination against COVID-19 (implemented under PNI) was designed through discussions of the Technical Advisory Chamber on Immunization and Communicable Diseases, which is composed by representatives from the Ministry of Health (including ANVISA and the Special Secretariat of Indigenous Peoples Health – SESAI), the Pan American Health Organization (PAHO), Conass (the National Council of State Health Secretariats), Conasems (the National Council of Municipal Health Secretariats), Health Professional Organizations, the Scientific Community and society, from public and private institutions, who are involved technically and scientifically with the topic. This plan was developed in line with the global guidelines of PAHO and WHO and defined the priority groups for vaccination based on scientific evidences of epidemiological risk including both individuals at greater risk for aggravation and death due to clinical and demographic conditions and social groups with a high degree of social vulnerability and, therefore, susceptible to a greater impact caused by covid-19. • PNI is part of Brazil’s National Health System (SUS) and has a demonstrated capacity to efficiently deploy vaccines to millions of people in a short period of time. PNI annually vaccinates 10 million children against polio in a Public Disclosure single day, reaches the most remote areas of the country and has large experience and good track-record delivering vaccines to Indigenous Peoples and other vulnerable communities. During the 2010 H1N1 pandemic, PNI vaccinated 80 million people in three months. As a result of PNI, infectious diseases such as polio, measles, neonatal tetanus, severe forms of tuberculosis, diphtheria, accidental tetanus, and whooping cough are now controlled. • SUS is guided by the principles of: (a) universality (guarantee of access to all people, regardless of sex, race, occupation or other social or personal characteristics); (b) equity; (c) comprehensiveness; (d) consideration of the regional and epidemiological diversities found in the country (health care services are planned according to epidemiological criteria and the socio-economic-demographic profile of the population to be served); and (e) social participation through municipal, state and national instances. • SUS gives special attention to disadvantaged and vulnerable populations. Over the past decades, national policies/programs have been created and implemented to serve the elderly (1994), people living with disabilities (2002), the Afro-Brazilian population (2009), the homeless population (2009), the rural and forest population (2011), the LGBTI+ population (2011) and Indigenous Peoples (2002). • In response to the demands of Indigenous Peoples, Brazil has established the Indigenous Health Care Subsystem (SasiSUS) as part of the SUS, in 1999, and instituted the National Policy of Attention to the Health of the Indigenous Peoples (PNASPI) that integrates the National Policy of Health, in 2002. • Federal Law 13,979/2020 and supporting deliberations of the Brazilian Supreme Court clearly state that none can be forced to be vaccinated against his/her will. • Brazilian labor and OHS regulatory framework is comprehensive and well established. • The National Solid Waste Policy and other CONAMA regulations determine the requisites for hazardous waste management. A recent publication from the Brazilian Association of Solid Waste Companies (ABRELPE Panorama 2020) indicates that the rate of proper medical waste disposal has improved in the last decade, but the May 06, 2022 Page 9 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) country still faces challenges, notably in the less affluent regions. For example, the rate of medical wastes disposed in deficient landfills varies from 10% in the Southeastern region to 34% in Northern region. However, further regulations on waste management have been set for vaccination campaigns (ANVISA RDC 222/2018_and strictly enforced by ANVISA and the state sanitary agencies and there is no news about inadequate segregation, storage and disposal of wastes with as part of the vaccination against Covid-19. • The relevant Brazilian legislation – the Immigration Law (Law 13,445/2017) and SUS – ensures to migrants and refugees (who count for 0.3% of the country’s population) the full access to public health, social assistance and social security services without discrimination based on nationality and migration status, but also highlights they may face challenges related with language barriers, cultural diversity and migrants' and refugees' common fears of discrimination and stigmatization when seeking for basic health services that need to be addressed. • The provision of personnel security services is also strictly ruled and will be detailed under ESS. ESS10 Stakeholder Engagement and Information Disclosure This standard is relevant. The Borrower has prepared a draft SEP that will be disclosed for online consultation before Appraisal. The SEP addresses the social risk related with access to information by: (a) emphasizing the necessity of keeping the Ministry of Health’s continued effort – through its dedicated websites and other media – to provide updated, comprehensive and inclusive information about the pandemia and the coverage, the availability and safety of vaccines to both the population, in general, and the most disadvantaged and vulnerable social groups (including people living in remote communities with difficult access to the national health system, Indigenous Peoples, and Public Disclosure other minorities, particularly those living in poverty); (ii) defining strategies for consultation with and reporting to key stakeholders in a manner that is proportional to the risks of the Project; and (iii) rendering available channels through which disadvantage and vulnerable social groups can raise their questions, concerns and complaints as well as to provide citizen feedback on the outcomes of the vaccination campaign. The SEP maps the key stakeholders - including the overall population and the priority groups for the vaccination campaign (individuals at greater risk for aggravation and death due to clinical and demographic conditions or with a high degree of social vulnerability who count for 76.4 million people. The SEP will be consulted with key stakeholders in a proportionate manner and its final version will be disclosed as early as possible but no later than 30 days after effectiveness and will be proportionate to the nature and scale of the Project activities, its potential risks and impacts and the size of the country. It will address the major social risk of potentially unequal access to information and channels to raise issues and concerns by disadvantaged and vulnerable social groups in a large country marked by regional disparities through three mutually supportive strategies. • First, to avoid misinformation the project will support a communication and community engagement aiming to maximize public understanding of the pandemic and the uptake of vaccines. Brazilian Risk Communication strategy is based on the disclosure of information through television broadcasting networks, radios, newspapers and other printed materials, online platforms and social media, that include: MoH’s portal to address issues related with COVID- 19 (https://coronavirus.saude.gov.br/); the Coronavirus-SUS App; and the website “Saúde sem Fake News” (www.saude.gov.br/fakenews), and Vacinômetro Covid-19 (https://infoms.saude.gov.br/extensions/DEMAS_C19_Vacina_v2/DEMAS_C19_Vacina_v2.html). The latest data available shows that 82.7% of the Brazilian population have access to the internet (including 65% of the Indigenous Peoples) and 96.3% of the households have access to TV. Websites of partner governmental agencies and other organizations may also be used. May 06, 2022 Page 10 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) Measures will be taken to ensure that project activities are clearly and timely informed through channels able to reach and address the concerns of various audiences (and particularly the most vulnerable social groups) and the channels for consultation, raising issues and providing citizen feedback on Project related activities are well- advertised. Whenever relevant, this information will be translated into different languages. Illiteracy and disabilities will be taken into consideration and inclusive communication channels will be made available to avoid minorities are not properly informed because of digital exclusion. It is worth noticing that more than 160 Indigenous Peoples languages are spoken in the country, but while only 17.5% of the Indigenous Peoples do not speak Portuguese, only 12 of those languages are spoken by more than 5,000 people. Nevertheless, information to Indigenous Peoples may require a bi-lingual oral translation. • Secondly, aiming at the goal of equitable and non-discriminatory access to Project benefits, the SEP will support an outreach and engagement strategy tailored to vulnerable social groups/priority groups for vaccination against COVID-19 within the population at large – and particularly the Indigenous Peoples. Considering the size of the country and the high level of accessibility to online platforms, engagement with the population at large will mostly rely on (a) the channels made available to citizens by MOH to receive regular feedback and requests of information (a WhatsApp phone number and the toll-free phone number of Call 136) and (b) the monitoring of social media and websites of key stakeholders (including representative entities of state and municipal governments, health professional and health service provider associations, and civil society organizations representing disadvantaged and vulnerable social groups and priority groups for vaccination. In line with the requirements of ESS 7, the Project’s engagement with Indigenous Peoples will rely on the well-established institutional channels for Indigenous Peoples participation and social control of health activities envisaged by SasiSUS: the Local Community Indigenous Health Councils, the 34 District Indigenous Health Councils (CONDISI) and the Forum of CONDISI Presidents as well as the Public Disclosure Covid National and District Crises Committees (see ESS 7). • Finally, the Project will rely on accessible, inclusive and responsive means to raise and redress grievances. Hence, an efficient Grievance Mechanism (GM) will be rendered available and will include specific channels and procedures to address grievances related with project implementation, SEA/SH complaints and the use of security forces or personnel. This GM will ensure access of Indigenous Peoples and other disadvantaged social groups in a culturally appropriate manner. The GM will have the following functionalities: different ways in which users can submit their grievances, which may include submissions in person, by phone, text message, mail, e-mail or via a website; a log where grievances are registered in writing and maintained as a database; publicly advertised procedures, setting out the length of time users can expect to wait for acknowledgement, response and resolution of their grievances; transparency about the grievance procedure, governing structure and decision makers; and an appeals process (including the national judiciary) to which unsatisfied grievances may be referred when resolution of grievance has not been achieved. The Client has proposed to use OUVSUS – the existing official SUS GM – for the Project. The Task Team assessed OUVSUS and the e-Ouv system (including the online platforms “Fala.BR” and “Painel Resolveu?”) and concluded they have the required functionalities, highlighting that the several channels to lodge complaints – the network of 1,022 OUVSUS offices, mail, a toll-free phone hot line (Call 136), OUVSUS website and a chatbot exclusively available for information on diseases and programs, campaigns and strategic actions of MOH) – minimize the concerns associated with digital exclusion of vulnerable social groups. Complaints can be anonymously submitted, minimizing potential risks of discrimination. OUVSUS can also get users’ satisfaction feedback and produce periodical reports on its performance. OUVSUS is integrated to the Comptroller General of the Union’s online platforms “Fala.BR” and “Painel Resolveu?”. The first allows access to 2,300 federal, state and municipal level ombudsmen offices, registers requests of May 06, 2022 Page 11 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) information and grievances and allows the users to monitor compliance with timelines, to consult on the responses provided and to make appeals. “Painel Resolveu?” is a digital monitoring tool that gathers information about citizens’ requests of information and complaints received daily through the e-Ouv system. It allows quick, dynamic and interactive searches by examining and comparing indicators. Researches can be made by level of government, specific sectors, governmental agencies, themes, subjects and periods of time. It provides information on the most demanded governmental agencies, the average time of response and resolution, the level of citizen satisfaction and some sociodemographic features voluntarily provided by users (age, gender, income and race). The data available shows that the e-Ouv system is accessible and used by vulnerable groups (including indigenous peoples). The information available through “Painel Resolveu” for the period between 2014 and 2022 shows that MoH received 32,755 requests of information, suggestions and complaints - the later counted for 22,7% of this total and 99.2% of them were responded (an average response time of 6.25 days). Covid-19 was the topic addressed in 21.1% of the requests of information and 14.1% of the complaints. During the preparation of the final SEP, the Task Team will work with the Borrower to ensure that: (a) the proposed GM is able to identify, track and regularly report on complaints related with Project-supported activities; (b) the GM is able to address SEA/SH complaints in a way that is compatible with World Bank guidance; (c) the GM is culturally appropriate and accessible to Indigenous Peoples; (d) the GM can handle complaints related with the use of security forces and/or security personnel in a way that is compatible with the ESSs; and (e) include measures that can be taken in the short-term to increase users’ satisfaction levels with resolution of grievances through the GM at least with regards to Project-related complaints. Monthly reports on complaints related with Project-supported activities will be sent by the GM to MoH’s Executive Secretariat, which will report semiannually to the Bank on the queries and complaints and how they have been Public Disclosure solved. The draft SEP will be disclosed for public consultation before appraisal and the final SEP will be prepared and disclosed as early as possible and within 60 days of Project’s effective date. B.2. Specific Risks and Impacts A brief description of the potential environmental and social risks and impacts relevant to the Project. ESS2 Labor and Working Conditions This standard is relevant. The Project will be carried out in accordance with the applicable requirements of ESS2, in a manner acceptable to the Bank. The Project workforce is expected to be composed by (i) direct workers – including public servants from MOH (in charge of project management, coordination, procurement and environmental and social risk management) as well as federal, state and municipal public servants in charge of the vaccination campaign. The scope of work of contracted workers may be limited to the logistic of vaccines and consultancies, as Covid vaccination in Brazil is being conducted by the public health services (including federal, state and municipal health agencies and the government’s civil servants). The Project will not engage community workers and is not expected to engage primary supply workers. Project workers – specially health professionals in charge of the vaccination – will be potentially exposed to occupational and health safety issues hazards. Preventative measures that will be taken in the vaccination campaigns shall ensure that project workers: (i) have access to adequate information on how to prevent contamination and infection; May 06, 2022 Page 12 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) (ii) enjoy environmentally clean and disinfected working places as well as appropriate working hours with breaks, overtime and periods of rest per week; (iii) receive all needed personal protection equipment (PPE) and refresher training on infection prevention and control (IPC) and use of PPE; (iv) be required to follow the proper protective procedures, but also be provided a blame-free environment in which they can report on incidents as well as are allowed to exercise the right to remove themselves from a work situation that they have reasonable justification to believe presents an imminent and serious danger to their life or health, and protected when exercising this right from any undue consequences. Brazil has a comprehensive OHS regulatory framework that is nationwide enforced by the Federal Secretariat of Labor that has power to issue notices, penalties and even suspend the operation of facilities that are not complying with the federal OHS regulations. OHS regulations are also supervised by the state sanitary agencies and the health workers councils.This framework encompasses thirty seven standards – known as NRs (Portuguese acronym for "norma regulamentadora"), including NR 32, dedicated to health services, specifying risk prevention measures (biological, chemical and radioactive risks), vaccination programs and compulsory use of personal protective equipment (PPE), among others requisites. Additionally, MoH has published an additional set of recommendations for the protection of health service workers in the care of Covid-19 (available at https://portalarquivos.saude.gov.br/images/pdf/2020/April/16/01-recomendacoes- de-protecao.pdf), which addresses the risk of infection faced by those working in the vaccination campaigns through the adoption of proper measures, including the use of PPE and adequate management of solid waste generated by vaccination stations. Health care workers in the frontline have also been included as a priority group in the country’s plan of vaccination. Public Disclosure OHS measures will be dealt with in the scope of the project’s Labor Management Procedures (LMP). In accordance with the applicable requirements of ESS 2, the LMP will also: • Confirm that civil servants engaged in Project supported activities will remain subject to the terms and conditions of their existing public sector employment agreements and ESS2 will not apply to them, with the exception for the provisions related with the Protection of the Work Force (on forced labor, child labor and minimum age) and OHS. • Ensure that Project workers directly engaged by MoH or through third-parties (direct and contracted workers) will be hired based on principles of non-discrimination and equal opportunity, no-harassment, and freedom of association. • Describe OHS measures to be adopted at the work places, including the provision of adequate supplies of PPE (particularly facemask, gowns, gloves, handwashing soap and sanitizer) and compliance with adequate OHS protections in accordance with General EHSGs and industry specific EHSGs and following evolving international best practice in relation to protection from COVID-19 for protection of health professionals working in vaccination campaigns. • Include the infection control precautions that have been developed by MoH and are available at https://bvsms.saude.gov.br/bvs/publicacoes/manual_procedimentos_vacinacao.pdf; https://www.gov.br/saude/pt- br/media/pdf/2020/dezembro/17/primeiro-informe_tecnico-do-plano_19_01_21_miolo-1.pdf, and https://www.vs.saude.ms.gov.br/wp-content/uploads/2021/01/Segundo-Informe-Tecnico-_COVID- 19_Atualizado.pdf. • Require that all project workers engaged on the vaccination are provide training on these procedures, hand and respiratory hygiene as well as adequate use of PPE. May 06, 2022 Page 13 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) • State the prohibition of child labor as well as forced labor, prohibiting children under 18 from being employed in the vaccination campaigns due to the nature of the work and possible exposure to Covid-19. • Require the availability of a responsive grievance mechanism to allow workers to quickly inform management of labor issues and raise workplace concerns and labor-related issues without retaliation (this mechanism will use the same uptake channels of the Project’s overall GM, but follow separate avenues for facilitating the resolution of labor- related complaints, as will be described in the LMP). • Explicitly state that the GM will be able to respond to SEA/SH complaints in a manner that is aligned with the World Bank guidance documents (such as the Good Practice Note on Addressing Gender Based Violence in Investment Project Financing involving Major Civil Works). The LMP will also provide information on MPT’s Coordination for the Promotion of Equal Opportunities and the Elimination of Discrimination at Work (https://mpt.mp.br/pgt/areas-de-atuacao/coordigualdade), that fights against social exclusion and discrimination, violation of the intimacy of the worker, moral and sexual harassment at the working places. It will inform that SEA/SH complaints – among other violations of the labor legislation – can be raised through MPT’s website (https://mpt.mp.br/pgt/servicos/servico-denuncie), App MPT Pardal (available for Android and IOS), by phone or in person. This information is treated as confidential and complaints can also be anonymously made. Upon denunciations, MPT opens processes to investigate the situations. The final SEP may provide for the dissemination of this information in all working places where Project supported activities will be carried out. • Include a code of conduct for project workers, to be applied to all workers under the project. • Include a section noticing that: • The enforcement of labor, employment, and social security legislation is usually made through the inspection of labor and social security authorities by means of a virtual platform referred to as "e-Social". These inspections are Public Disclosure carried out by the Secretariat of Labor and Employment Inspection (under the Ministry of Economy) and can be executed randomly or result from a complaint (by employees, former employees, or third parties) or lawsuits. If any irregularities are found, the authorities may apply fines and administrative sanctions against the employer. • The enforcer of the Brazilian labor and employment law is the Labor Prosecution Office (MPT), which has powers to protect the collective rights of employees. MPT oversees compliance with labor legislation, seeking to regularize and mediate relations between employees and employers, defending collective interests, or acting extrajudicially in the resolution of conflicts, either after receiving complaints, representations, or on their own initiative. MPT may negotiate a Term of Conduct Adjustment by which the employer agrees to comply with certain obligations, being subjected to penalties, or file a public civil action to have the enforcement of such obligations, or act as an arbitrator or mediator. MPT is centered in Brasília-and divided among 24 regional agencies and many local agencies spread all over the Brazilian territory. • The law permits an out-of-court mediation with the labor agency to resolve labor disputes (also referred to as Mesa Redonda or "Roundtable") and the possibility to settle disputes through an internal committee (referred to as Comissão de Conciliação Prévia or "CCP"). Arbitration also could be used to resolve collective and individual disputes. • State that OHS and labor requirements will be inserted into the ESHS specifications of the procurement documents and contracts with contractors and supervising firms, including specific provisions requiring all contractors to prepare and implement codes of conduct for their workers and management. The LMP will be prepared, disclosed, adopted and implemented by MoH no later than 60 days after the Project’s effectiveness date). ESS3 Resource Efficiency and Pollution Prevention and Management May 06, 2022 Page 14 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) This standard is relevant as the transport, storage, and handling of vaccines as well as disposal medical wastes produced by the vaccination campaign pose potential risks that must be properly managed to avoid damage to the environment and human health. Inappropriate disposal of the vaccination campaign wastes may lead to contamination of soil and groundwater, but more importantly, to further propagation of diseases. The Brazilian legislation is in line with the ESF requirements, notably, with the ESS3 and the World Bank Group’s EHS guidelines. The Federal Law N° 12305/2010 determines the requisites for managing solid wastes, (including hazardous materials). Hazardous waste management, storage, transport and final disposal is regulated by the CONAMA resolutions, including Resolution 358/2005 that regulates final disposal of medical wastes. Additionally, the Federal Sanitary Agency – Anvisa Regulation RDC 222/2018 determines the requirements for health wastes management and disposal. As previously mentioned, a recent publication from the Brazilian Association of Solid Waste Companies (ABRELPE Panorama 2020) indicates that the rate of proper medical waste disposal has improved in the last decade, but the country still faces challenges, notably in the less affluent regions. For example, the rate of medical wastes disposed in deficient landfills varies from 10% in the Southeastern region to 34% in Northern region. However, further regulations on waste management have been set for vaccination campaigns (ANVISA RDC 222/2018_and strictly enforced by ANVISA and the state sanitary agencies and there is no news about inadequate segregation, storage and disposal of wastes with as part of the vaccination against Covid-19. Anvisa regulations are compulsory for all health facilities/services in the country and set strict requirements for generation, identification/classification, handling, segregation, temporary storage, collection, transport and final disposal of medical wastes, including the obligation to keep the documentation to demonstrate that medical waste are being disposed in accordance to the legal requirements. Important to note that medical wastes in Brazil are Public Disclosure stored, collected and disposed, completely separate from municipal solid wastes. Medical wastes regulations are enforced by diverse entities, including Anvisa, the MOH, the Ministry of Environment, state and municipal sanitary agencies. The information available (based on MoH’s Grievance Mechanism and a screening exercise of news on the roll-out of the vaccination campaign in the national media) points out that there have been no issues related with no- compliance with national regulations on waste management. The MOH confirmed that there is no indication of health and safety and medical waste management in the Covid-19 Vaccination campaign. The ESMF will include a section addressing, specifically, the environmental, health and safety track record of Covid-19 vaccination campaign, aiming to confirm alignment with national regulation and GIIP. The risks related to vaccination campaigns are limited, as the Brazilian National Immunization Program-PNI has detailed guidance for transport, storage and distribution of vaccines, including cold chain requisites. The guidance defines requisites for organization and operation of vaccination rooms, basic supplies and equipment specification, and the cold chain specification. Vaccines shall be transported by refrigerated or acclimatized vehicles, with trained personnel, and schedules that are usually established to mitigate risks of loss of vaccines. For short distances, distribution from the States to the municipalities, this transport can be done in thermal boxes. The packing of the immune-biologicals during the transport takes into account the conservation temperature and the time foreseen for the displacement. In the thermal boxes used for the transportation of immune-biologicals (-20ºC) it is used dry ice (CO2) in quantity compatible with the time of displacement and volume to be transported. AstraZeneca vaccines, widely used in the ongoing campaign, must be conditioned at a temperature of +2ºC to +8ºC, in cold/refrigerated chambers. In sum, the country’s regulatory framework and institutional capacity can minimize the Project’s the potential negative impacts on the environment. May 06, 2022 Page 15 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) The ESMF will review the Brazilian legislation (which is extensive and complex), aiming to identify potential gaps in relation to ESS3 and the World Bank Group’s EHS Guidelines, (e.g. WBG EHS Guidelines for Hazardous Materials Management and Waste Management), and Good International Industry Practice (GIIP). The ESMF shall verify the consistency of the vaccination procedures with WHO vaccination guidance, including a specific section on infection prevention and control and waste management procedures (IPC&WMP), and verify whether the guidance issued by the MOH’s on vaccination protocols for COVID-19 are in line with the ESF requirements and WHO guidelines. The ESMF shall confirm, specifically, if the local guidelines for the use of personal protective equipment (PPE), bio-security measures, protocols for handling medical waste, environmental health and safety guidelines for staff, are in accordance the ESF requirements. ESS4 Community Health and Safety This standard is relevant. Risks related with community health, safety and security will be addressed, avoided and minimized according to ESS4. The roll-out of the vaccines against Covid-19 may pose the risk of unintentionally exposing beneficiary communities to increased transmission during vaccination and communication efforts. This risk can be properly mitigated by strictly following infection prevention controls and biosafety protocols public issued by MoH, WHO and the World Bank as well as ensuring health information and availability of the proper supply of PPE to all workers in the vaccination frontlines who may enter in contact with the population. The technical notes issued by MoH include detailed vaccination procedures, the description of PPE and materials that must be available and used, and waste management and disposal procedures. A guide for coping with the Covid-19 in the public health network was issued Public Disclosure (https://www.conasems.org.br/wp-content/uploads/2021/01/Informe_Tecnico_Vacina_COVID-19.pdf), bringing information on the new variants of the SARS-CoV-2 virus, reinfection, vaccines, and updated information on diagnosis, risk evaluation, and mental health, among other topics. Furthermore, procedures to prevent or minimize the spread of infectious diseases and conduct the vaccination campaign in a safe manner are detailed in the National Operationalization Plan for the Covid 19 Vaccination (https://www.gov.br/saude/pt-br/coronavirus/vacinas/plano- nacional-de-operacionalizacao-da-vacina-contra-a-covid-19). It also includes protocols for monitoring and responding to adverse events following immunization (https://www.gov.br/saude/pt- br/media/pdf/2020/dezembro/21/estrategia_vacinacao_covid19.pdf). Information on the vaccine provided and the person vaccinated is gathered, registered and fed into the national Open DataSUS database, allowing the monitoring and investigation of adverse events following immunization. Information on the vaccination campaign at the country, regional, state and municipal level (by some sociodemographic characteristics and priority groups) is publicly disclosed and daily updated in MoH’s dedicated monitoring online platform and can also be obtained at the National Health Council’s “Vacinômetro” (http://conselho.saude.gov.br/vacinometro). In Brazil, the roll-out of vaccines against Covid-19 takes advantage of the countries large primary care health network that counts with around 42,000 primary health care centers distributed across the country. The challenges for implementing vaccine cold chain temperature monitoring across the country was known prior to the Covid 19 outbreak and MoH issued, in 2017, the 5th Edition of the Vaccine Cold Chain Manual, aiming to support the yearly vaccination campaigns of the National Immunization Program (available at https://portalarquivos2.saude.gov.br/images/pdf/2017/dezembro/15/rede_frio_2017_web_VF.pdf). The legislation ruling vaccination against Covid-19 bars the practice of forced vaccination (Law 13.979/2020 and Supreme Court decisions on Direct Unconstitutionality Actions 6586 and 6587 and the Extraordinary Appeal with May 06, 2022 Page 16 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) Grievance (ARE) 1267879, which discusses the right to refuse immunization due to philosophical or religious convictions). The ESMF will review the biosafety protocols described above and propose – as needed - additional biosafety measures to be followed by frontline health workers carrying out the vaccination. Particular attention will be given to protocols followed in areas where Indigenous Peoples are located because of their vulnerability to infectious respiratory diseases and communal way of life, which facilitates the fast spread of Coronavirus. The ESMF will also detail procedures for managing environmental and social incidents directly related to Project-supported activities, which will be reported to the Bank within 48 hours after acknowledgement by MoH’s Executive Secretariat. The ESMF will also assess and address risks related with the use of security personnel for surveillance of vaccination stations. The provision of services of personnel security in Brazil is well established; regulated by federal legislation and supervised by the Federal Policy Department of the Ministry of Justice. The regulatory framework includes strict procedures for establishing a security provision company as well as for hiring security personnel, including: verification that the workers are not implicated in past abuses or misdemeanors, prior adequate training and certification. The use of excessive force is forbidden and these companies have to report, regularly, to the Federal Police. The Project’s ESMF shall revise the current security procedures and incorporate additional measure (as appropriate) aiming to assure their adherence to ESS4 principles. The Project ESMF will also consider the scope of an eventual engagement of military forces to deploy vaccines in remote located areas (and, particularly, in Indigenous Lands) and include a summary of the risks of the use of security forces, including in relation to groups vulnerable to exploitation and discrimination. It is relevant to point out that less than 2% of the Brazilian population live in such remote locations and it is critical to highlight that military forces have been engaged in the deployment of vaccines in remote and hard to access locations as part of the National Public Disclosure Immunization Plan for the last 20 years without incidents and that guidelines for the relationship between military forces and Indigenous Peoples have been consulted and agreed with the later and disclosed and adopted through the Ministry of Defense Ordinance 983/2003. The ESMF will state that, whenever military forces are mobilized, MoH will ensure that they will be deployed in a manner consistent with applicable national law, the existing military code of conduct (Law 6.880/1980), the guidelines set in Ministry of Defense Ordinance 983/2003 and the guidelines from the Bank’s Technical Note on the “Use of Military forces to assist in Covid-19 operations suggestions on how to mitigate the risks”. The ESCP states that whenever complaints related with unlawful and abusive acts (including excessive use of force and SEA/SH) by members of military forces and security personnel are received through the project’s Grievance Mechanism (or any other means), they will be reported to the World Bank within 48 hours of acknowledgment and to the relevant military/police authorities, reviewed and acted upon (or request appropriate parties to take action) to prevent recurrence. The ESCP also states that the Project’s Grievance Mechanism will be equipped to receive, register, and facilitate the resolution of complaints related with sexual exploitation and abuse, sexual harassment (SEA/SH), including through the referral of survivors to gender-based violence service providers, all in a safe, confidential, and survivor-centered manner (further information on referral services for GBV and SEA/SH victims is provided above under the SEA/SH risk section). ESS5 Land Acquisition, Restrictions on Land Use and Involuntary Resettlement This standard is not currently relevant. The outcome of E&S screening did not identify any potential risks and/or impacts relevant to ESS5. The project will neither finance nor support any civil works except in established facilities. The Project will not require land acquisition that would result in the impacts covered under this standard. May 06, 2022 Page 17 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) ESS6 Biodiversity Conservation and Sustainable Management of Living Natural Resources This standard is not currently relevant. Health services infrastructure that may cause pollution and waste will be managed through licensed operators that would not imply risks to natural habitats or biodiversity. ESS7 Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Local Communities This standard is relevant. Project activities neither require forced eviction of Indigenous Peoples, nor involve the three circumstances in which FPIC must be obtained. Vaccination is not expected to impact intangible cultural heritage. As Indigenous Peoples (IPs) will not be the sole beneficiaries of the Project, the Borrower will ensure that Project design and implementation provide IPs with equitable access to its benefits. The Project will be implemented at the national level and there are 305 different IPs in the country, comprising 0.4% of the population. Out of them, only 17.5% do not speak Portuguese and 65% are users of the Internet. IPs living within Indigenous Lands have been included among the priority groups for vaccination due to their disproportionately higher risk of severe disease or death, their vulnerability to infectious respiratory diseases and communal way of life that facilitates the fast spread of Covid-19. According to official data (April 8, 2022), 64.696 cases of Covid-1 were confirmed among IPs, leading to 903 deaths; 91% of the indigenous population aged 18 years and over had received the 1st dose of the vaccine (374,577 people) and 86% had received the 2nd dose (354,501 people). Brazil has a dense network of civil society and representative IPs organizations. During project preparation, the task team has examined the websites of these organizations and fount that they have championed for protective actions Public Disclosure and legislation (such as Law 13,021/20) and always positioned themselves in favor of social distancing measures (including the establishment of sanitary barriers and prohibition of entrance of outsiders in Indigenous Lands) and, particularly, the priority vaccination of IPs. They denounced misinformation communications that were creating fear and hesitancy with regards to vaccination, complained of the early slow pace of vaccination and questioned the accuracy of the data on Covid-19 among IPs. They have established monitoring watchdog systems and produced and disseminated reports on the situation – such as the “Transparência COVID-19 3.0” platform of the Open Knowledge Brazil (which crosses data from Open DataSus with the information on SESAI IPs immunization panel and has pointed out a slower pace of IP vaccination than officially announced), the “Overview of Covid-19” webpage hosted by the Coalition of Indigenous Peoples of Brazil (APIB), and the report “Our Fight Is for Life” (by the National Committee for Indigenous Life and Memory). Their main and most recurrent requests – which implementation by the federal government was also demanded by the Brazilian Supreme Court – referred to the adoption of sanitary barriers and social protection measures in indigenous lands, improved register of race and ethnic identity in the epidemiological and vaccination records, and the inclusion of IPs living outside of homologated indigenous lands in the priority group for vaccination. In Brazil, public health care services to IPs are provided through the Subsystem of Attention to Indigenous Health (SasiSUS) and the National Policy for Indigenous Peoples Health Care (PNASPI). SasiSUS and PNASPI are major conquests of the mobilization and civic action of Indigenous Peoples and their representative organizations. SasiSUS was instituted by Federal Law 9,836/99 as part of SUS and is obliged to take into account the local realities and the specificities of IPs cultures. PNASPI (instituted in 2002) determines the creation of a health service network in indigenous lands, which is structured around 34 Special Indigenous Peoples Sanitary Districts (DSEI) under the coordination of MoH’s Special Secretariat of Indigenous Peoples Health (SESAI). The geographic delimitation of each May 06, 2022 Page 18 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) DSEI considers demographic and ethno-cultural aspects. In addition, medium and high complexity health care for IPs is ensured through MoH’s Incentive for Specialized Care to IPs Program that supports 59 licensed hospitals across the country. SasiSUS is an administratively and budgetarily independent sub-system within SUS and fully financed by the federal government. Participation of IPs in SasiSUS is provided through the organization every four years of local, district and National Conferences of Indigenous Health and five of them have been held since 2002. It also occurs on a more frequent basis through Local Indigenous Health Councils (CLSI) and Indigenous Health District Councils (CONDISI). In 2020, the Indigenous District Health Council Chairmen's Forum (FPCONISI) was established as SESAI’s advisory body with the objective of participating and monitoring the execution of PNASPI. FPCONDISI is composed by the chairmen of the 34 DSEIs. In response to Covid-19, SESAI also instituted District Crises Committees (weekly meetings) and a Central Crises Committee (monthly meetings), all counting with participation of IP representatives. Several measures were taken to prevent or minimize Covid-19 outbreak within indigenous lands. Contingency Plans for Human Infection with the new Coronavirus (COVID-19) in Indigenous Peoples – which recognize and respect traditional healing methods, governance structures, customs and beliefs and call for translation of relevant information to the native languages as needed – were prepared and implemented for each one of the DSEIs and for the country. Sanitary barriers were established aiming to forbid the entrance of outsiders within indigenous lands and quarantine measures were taken to grant access of health professionals in these areas. PPEs and disinfectant materials were distributed and health professionals received training on prophylactic measures. Extra precaution measures were adopted with regards IP groups of recent contact or in voluntary isolation. A strategy to provide Covid-19 services to IPs – called Indigenous Primary Care Unit (UAPI) – was launched, aiming to strengthen primary health care services for the IPs (by May 2021, 289 UAPI were operating). Law 13,021/20 set measures to contain the Public Disclosure spread of the virus among indigenous, quilombolas and other traditional peoples and communities while ensuring their basic needs and livelihoods. A National Crisis Committee for planning, coordination, execution, supervision and monitoring of the impacts of COVID-19 among IPs was instituted by SESAI Ordinance 36/2020 and is formed by the Central Crisis Committee and representatives of the 34 District Crisis Committees. A series of educational videos and booklets with guidance about Covid-19 to IPs, indigenous health agents, indigenous sanitation agents and other health workers was published and distributed in Portuguese and indigenous languages (including those spoken by the largest number of IPs). During Project implementation, it is key that information on vaccines, their availability and safety continue to be provided to IPs and that they are able to provide feedback on the vaccination campaign. This engagement will mostly rely on the institutionalized channels already in place and operationalized in the scope of SasiSUS – namely: (a) the CLSI that (i) are made up only of representatives of the indigenous communities, including traditional leaders, indigenous teachers, indigenous health agents, traditional specialists, midwives and others, chosen by the communities encompassed by the DSEI and (ii) responsible for monitoring, evaluating and giving feedback on the implementation of indigenous health care in their communities, electing members of CONDISI and Municipal Health Councils and making recommendations to CONDISI and the District Indigenous Health Plans; (b) the CONDISI that is composed by 50% IPs’ representatives from all the different ethnic groups found within the DSEI, who are responsible for the preparation, approval, monitoring and evaluation of the District Indigenous Health Plan; (c) FPCONDISI; and (d) the Central and District Crises Committees. Therefore, information on the Project will be provided during the meetings of CLSI and CONDISI and orally translated to indigenous languages as needed. Feedback from IPs will be gathered at these meetings. Extra precautions will be taken when conducting these stakeholder engagement activities to minimize the risk of Covid-19 transmission. The Project’s final SEP will assess potential risks related to May 06, 2022 Page 19 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) access to the Project’s GM system by IPs and measures will be proposed – as needed – to address these risks and ensure the GM is culturally appropriate and accessible to IPs. It is worth to highlight that, since 1993, The National Immunization Plan has relied on military forces to deploy vaccines in remotely located Indigenous lands and guidelines on the conduct of the military forces have been consulted with IPs and adopted by MD Ordinance 983/2003. The ESMF will consider risks related to the interaction between IPs and military forces that may be eventually involved on the deployment of vaccines in remote locations and propose – as needed – further precautionary measures. The core elements of an IPPF will be included in the Project’s ESMF (which will assess the distinctive risks that may be faced by IPs), SEP (which will describe an engagement process tailored to promote the participation of IPs in culturally appropriate manners), and ESCP. ESS8 Cultural Heritage This standard is not currently relevant. There will be no civil works and no earth excavation under the project and it is not expected any possibility of directly or indirectly affecting tangible or intangible cultural heritage. ESS9 Financial Intermediaries This standard is not currently relevant. C. Legal Operational Policies that Apply Public Disclosure OP 7.50 Projects on International Waterways No OP 7.60 Projects in Disputed Areas No B.3. Reliance on Borrower’s policy, legal and institutional framework, relevant to the Project risks and impacts Is this project being prepared for use of Borrower Framework? No Areas where “Use of Borrower Framework” is being considered: It does not apply. IV. CONTACT POINTS World Bank Contact: Pablo Ariel Acosta Title: Program Leader May 06, 2022 Page 20 of 21 The World Bank BRAZIL COVID-19 RESPONSE AND RECOVERY PROJECT (P176796) Telephone No: 5761+8610 / 55-61-33298610 Email: pacosta@worldbank.org Borrower/Client/Recipient Borrower: Ministry of Finance Implementing Agency(ies) Implementing Agency: Ministry of Health V. FOR MORE INFORMATION CONTACT The World Bank 1818 H Street, NW Washington, D.C. 20433 Telephone: (202) 473-1000 Web: http://www.worldbank.org/projects VI. APPROVAL Task Team Leader(s): Pablo Ariel Acosta Practice Manager (ENR/Social) Genevieve Connors Cleared on 06-May-2022 at 14:11:52 GMT-04:00 Public Disclosure Safeguards Advisor ESSA Angela Nyawira Khaminwa (SAESSA) Concurred on 06-May-2022 at 16:11:9 GMT-04:00 May 06, 2022 Page 21 of 21