E725
Volume 1
Assessment of the Environmental Legal framework for
AIDS/STD Control Project in Brazil
Eu vironunental legislation in Brazil
Environmental legislation in Brazil is based on a framework classified according to federal, state
and municipal competencies. According to the National Council for Environment (CONAMA),
depending on the extent of the environmental impacts and the project's area of influence,
licensing of projects, public or private, will depend on federal, state or municipal responsibility.
Projects with nationwide interventions, involving neighboring countries, affecting indigenous
lands, are subjected to the federal competence of the Brazilian Institute for Environment and
Natural Renewable Resources (IBAMA). Projects affecting more than one municipality, or
whose impacts would affect the territory are subjected to state competence. Environmental
licensing of those activities or projects with impacts limited to local influence fall in the
competence of municipalities.
Environmental legislation dates back to 1954, when Federal Law 2.312 stating that the collection,
transport and disposal of waste should be processed under conditions that do not cause
inconveniences to health or public well-being". Federal Law No. 6938 of August 1981
established the National Council for the Environment (CONAMA) assigning it the mandate to
formulate national environmental policy. The Environmental legislation has undergone a several
amendments, with the CONAMA Resolution 283 of July 2001 being the most recent amendment.
Current Environmental National Law establishes clear procedures for environmental assessment
of those activities, civil works and services with a significant environmental pollution potential.
Implementation of such works, activities or services depends on norms and regulations defined in
CONAMA resolutions nos. 5/93 and 283/01. Detailed procedures are described in Annex 1.
Environmental legislation associated witli waste inianageunent anid disposalfromtl health
services centers in Brazil
The constitution of 1988 which formed the Sisteina Uniico de Satide (SUS), states in article 23
that the protection of the environment and the control of pollution are the shared responsibility of
the Federal Government, States and Municipalities. Current legislation (CONAMA resolutions
5/93 and 283/01), specifically addresses health services and solid waste collection, transport,
treatment and disposal It includes in health care wastes, wastes derived from hospitals,
laboratories, clinics, veterinary clinics, blood banks, medical outpatient services and dentistry.
According to resolution 5/93, each health unit generating medical wastes is responsible for the
safe sanitary and environmental management of its wastes (from generation to final disposition)
including the proper separation, condition, and identification of wastes; proper environmentally
and sanitary temporary safe storage; and responsible for adopting clean production solutions.
Each facility is also responsible for the preparation and faithful execution of a Health Services
Waste Management Plans (HSWMPs) to be approved by environmental and health authorities.
Resolution 283/01, the most recent bill to be passed at the federal level (July 2001), improves and
complements Resolution 5/93. It specifies that procedures followed in waste management need
to be those defined by the National Sanitary Surveillance Agency (ANVISA) and the National
Environmental System, and that the treatment of wastes needs to be conducted in facilities and
equipment licensed by the said agencies.
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With respect to environmental licensing of health centers, which became obligatory through
Federal Law No. 6938/8 1, they can be carried out at the federal level by IBAMA, or state and
municipal levels, depending on the location and complexity of the facility, but is generally carried
out at the municipal level. There are six types of environmental licenses: Site, Construction,
Installation, Expansion, Alteration, and Operation License.
*  Site location environmental license. Preliminary license. Approves project location, scope,
and environmental viability, sets out basic requisites and conditionalities to be addressed in
further stages of project implementation.
*  Construction license. Clears out if project has been constructed according to design
specifications, including environmental control measures.
*  Installation license. Approves project prior to operation to ensure it meets agreed standards.
*  Operations license. Approves during project operation if activities are in agreement with
previous licenses.
*  Modification and Expansion licenses. If current operation needs to be altered.
HSWMPs must include all necessary licensing processes.
Legislation associated with Sanitary and Environmental Surveillance
The legal framework of Sanitary Surveillance also follows federal, state and municipal
distribution. Federal Constitution of 1 988 institutionalized the Sistenia Unico de Salud (or SUS),
a decentralized network of actions and public health services following an integrated approach
with an active participation of communities. At the federal level, the National Sanitary
Surveillance Agency (ANVISA) is responsible for national surveillance. 'Within the SUS, state
level Sanitary Surveillance includes environmental protection and sustainable development; basic
sanitation; food and water, drugs; health and the working environment, health services and
assistance; production of toxic and radioactive material, blood and derivatives, amongst others.
At the state and regional levels, the Directorate for Sanitary Surveillance and Control (DIVISA),
is responsible for providing planning, coordination, advisory, supervision and assistance to
municipal and regional sanitary surveillance activities. At the municipal level, municipalities are
responsible for inspection and monitoring of public services (e.g. food, pharmaceuticals, and
health services). Depending on the level of development of municipal health services and the
implementation of the decentralized SUS, municipal sanitary surveillance can be classified in
either low complexity (municipalities implementing the Basic Care Management), or medium to
high complexity (municipalities implementing the Full Management of the Municipal System).
Norms and standards associated )Vit/h man agemnent andfinal disposal of wastesfrom healtlh
services.
The management of bio-hazardous waste is considered in both federal and state legislation.
Norms and procedures for the proper management and final disposal of health wastes are clearly
defined through the norms of the Brazilian Association of Technical Norms (ABNT). Norms for
classification of solid wastes (NBR 10004), specifications for plastic bags suited for solid waste
conditioning (NBR 9190), classification of health services wastes (NBR 12808 and 807), and
management of health service wastes (NBR 12810), are some of the current nonms regulating
most of the activities associated with the management and final disposal of wastes from health
services.
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Wastes from health services are classified according to their biological, physical and chemical
characteristics. By law, all health centers are responsible for the classification of their wastes,
according to the following categories:
Group A: Biological (infective) wastes. Wastes containing biological agents or wastes
contaminated with biological wastes, posing high contamination risks to the environment and to
public health, such as blood bags, collected organic fluids and secretions, vaccines and culture
dishes, disposable materials in contact with organic fluids, body parts ad pieces, animals, air
condition filters from isolated rooms, wastes from isolated patients, cutting instruments, and
sludge from health centers' wastewater treatment.
Group B: Chemical wastes. Waste with high contamination risk from their chemical
constituencies, such as corrosive materials, inflammables, expired pharmaceuticals, bactericides,
mercury and lead, disinfectants, cancer treatment drugs, and alike.
Group C: Radioactive wastes: Radio-nuclide wastes, including those type A, B, and D,
contaminated with radio-nuclides.
Group D: Common wastes; non-high risk wastes, including paper, plastic, plants and shrubs,
food wastes non-contaminated with organic fluids or those coming from isolated patients.
Most of the services supported under this project fall under Group A, all sub-classifications A2,
A3, A4 and A5 and Group B, sub-classification B2.
Al: Biological wastes: cultures, inoculations from clinical or research laboratory.
A2: Blood and hemo-derivatives: contaminated blood products.
A3: Surgical, pathological: tissue, organ, fetus, blood infected residuals of surgical intervention.
A4: Cutting or perforating: syringes, scalpel blades, pipettes, flasks, vials.
A5: Care to patients: secretions, excretions and other organic liquids derived from patients and
any residues contaminated by those materials.
B2:: Pharmaceutical residue: dated medications, contaminated medications, unused medications.
Proper segregation, identification and conditioning of health residues must be done at each health
center. Groups A, B, and C wastes, except cutting wastes, must be separated and disposed in
standardized plastic bags, and properly labeled. Cutting wastes must be discarded in rigid
containers, and also properly labeled. Once properly segregated and labeled, wastes must be
stored extemally for collecting.
Potential Environmental Impacts Associated with the Brazil AIDS & STD
Control Project III
As the project description in Annex 2 describes, project activities focus on prevention and
diagnosis of HIV and STDs, and treatment and care for those infected. It also has a component
designed to strengthen the capacity of research centers, laboratories and universities to engage in
scientific and technological (clinical and biological) research and development (R&D) to improve
the effectiveness of treatment and prevention of HIV/AIDS, and the development of such
research. Project activities will take place primarily in the 411 municipalities containing 98% of
all AIDS cases, most of which are very urbanized. Even though the Project does not have a direct
impact on the environment, the provision of health services, and the implementation of laboratory
and clinical studies, may generate medical wastes which might have direct environmental
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implications, since the final disposition of these wastes might have an impact on surrounding
natural resources which, if are not handled properly can have negative effects.
The objective of this section is to identify the possible environmlental implications of the project
and its components, and from there include the necessary considerations for its prevention and
mitigation in each component to guarantee the environmental quality and sustainability of the
decisions of the technical assistance and investment activities intended.
Potential environmental impacts associated with the Project.
As noted above, the project is expected to generate only type A and B waste. The following table
indicates the types of waste generated by each source of potential waste:
ORIGIN                              WASTE TYPE
Patient                             Groups A and B2
Specialized Ambulatory Services (SAE)  Groups A and B2
Conventional Hospital               Groups A and B2
Day Hospital                        Groups A and B2
Home Care (ADT)                     Groups A and B2
Laboratories                        Groups A and B2
Pharmacies                           Group B2
In the area of prevention, which generally takes place in the community, the only type of medical
waste generated is in harm reduction programs for intravenous drug users which include needle
exchange components. With regards to treatment and care, which takes place in the home, SAEs,
day hospitals, and accredited conventional hospitals, potential risk arises from unprotected
handling of blood or body fluids of infected individuals (including HIV, Hepatitis B and C, and
other STDs), and from wastes emanating from the treatment in health facilities and from
laboratory work. And, in the case of clinical and biomedical research, Group A wastes may be
generated, and possibly some of type B2. With respect to waste derived from treatment and care
in health facilities, it is important to note that the use of ART and the availability of alternative
ambulatory care facilities has led to a substantial reduction in hospitalizations, with most care
being provided in ambulatory units or at home (SAEs, ADTs, Day Hospitals), which a study
conducted as part of AIDS 11 found that these generate about 80% less waste material than large
hospitals, and with far lower hazard levels. Other some minor works, no civil works will be
financed by the project.
With respect to the management of waste in prevention programs, the IDU harm reduction
program developed guidelines for the management of syringes in needle exchange programs. The
project team collects used syringes in suitable containers or boxes for storage before sending
them to the local health-service unit. With respect to the management of waste in home-based
care activities, participating NGOs and health service staff who perform home visits, guidelines
hve been developed on bio-safety precautions in the handling of blood, secretions and excretions,
and in contact with mucus material and loose skin. Guidelines also specify how to dispose of
solid healthcare waste, as well as the use of individual protection equipment, the purpose of
which is to reduce the exposure of healthcare professionals to blood or other body fluids. In
addition, there are recommendations on specific precautions to be taken when handling and
disposing of cutting and perforation implements contaminated by organic material. The program
has provided training for these staff on a regular basis.
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With regards to the management of waste in health facilities, both federal and state legislation
clearly define procedures for the proper management and final disposal of health wastes. Each
health unit is responsible for the preparation and implementation of a Health Services Waste
Management Plans (HSWMPs) which clearly set out procedures for the proper separation,
condition, and identification of wastes, and proper environmentally and sanitary temporary safe
storage. Moreover, HSWMPs must be part of each environmental license. To ensure compliance
the program developed a long distance learning program (TELELAB) for laboratory workers and
hemotherapy units to train them on health care waste management specific to AIDS/STD
treatment and care which has been functioning for at least 6 years. In addition, the program
provides an average of three one-week courses for each health care modality (SAE, conventional
Hospitals, Day Hospitals and ADTs) on Care and Treatment Management, including a bio-safety
module, and training for family to provide primary healthcare in STD/HIV/AJDS. In order to
expand its service delivery network, the program has provided training, equipment and supplies
to conventional hospitals so that they can become accredited to provide specialized services to
patients with HIV/AIDS. Visits to Bahia and Goias indicated that local sanitary and
environmental procedures for proper handling and disposal of medical wastes are applied. There
is however, a need to train health sector staff and NGOs in the 261 municipalities that will be
participating under AIDS III that were not working oni AIDS activities before.
In conclusion, there are no major environmental issues associated with the Project. Work on
prevention, which generally takes place in the community, has if anything, positive
environmental effects given its emphasis on health promotion. With regards to treatment and
care, most services take place in outpatient facilities which generate 80% less waste than
hospitals. As to disposal of waste in health facilities and laboratories, the program has adequate
procedures in place. No additional technology for managing health care wastes is needed to in the
treatment of HIV/AIDS. Training for staff on handling of blood products and delivering health
care to HIV/AIDS patients is a regular program activity. It can therefore be concluded that the
environmental impacts arising from implementation of the AIDS III project are controllable with
relatively simple measures.
Project Environmental Classification and Environmental Management Plan (EMP)
Considering the scope of the project and the environmental impacts associated with each
component, the Brazil AIDS & STD Control III Project should be considered as Environmental
Category B.
The limited negative environmental impacts that could occur can be significantly attenuated by
following of guidelines already developed and providing regular training for all new participating
entities. The latter is an integral part of the project. It should be noted that REFORSUS, a project
financed by IBRD and IDB, developed guidelines for the implementation of HSWMPs which are
being adopted by the SUS network. Guidelines currently employed by the project will be
reviewed to ensure they incorporate all procedures recommended by the REFORSUS guidelines,
and will be included in the project's Operational Manual. All new participating facilities will
have to submit an HSWMP that adequately addresses the handling of health care wastes
emanating from project activities. None of these activities will imply additional costs to those
already included in the project.
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Appendix
Legal Framework
DESCRIPTION                   INTERPRETATION
Brazilian Constitution of     I The issue of solid waste related to health and the environment is a constitutional matter
1988
2 The following are federal, state and municipal responsibilities
*   Declares health to be
the  "right of each       *   protection of the environment
person and the duty of    *   control of pollution
the state".
*   participation in policy formulation and in execution of basic sanitation actions
3 Government (federal, state and municipal) is responsible for inspecting and overseeing
polluting or potentially polluting activities, and for establishing standards, directives and
procedures
4. Municipalities are responsible for the following
*   Organizing essential public services at the local level, and providing them directly, or
under concession or permit
*   Provision of public sanitation services, including sweeping, collection, transport and
final disposal of solid waste generated by the local community
Federal   Decree  76,973   of This decree regulates and standardizes projects for the construction and installation of
December 31,1975              buildings destined for the provision of health services, as established by the Ministry of
I-lealth It also regulates facilities for proper final disposal of excrement.
MINTER         Administrative First federal legislation to deal specifically with hospital waste material, requires compulsory
Order 53 of 01/03/79          incineration thereof and prohibits the use of other methods.
Law No. 6938 of 1981          This law establishes the National Environment Policy, setting up the National Environment
System  (SISNAMA), together with its consultative and deliberative body, the National
Environiment Council (CONAMA), and executive body, the National Institute for the
Environment and Renewable Natural Resources (IBAMA)
CONAMA Resolution 006/91      This decision revokes the exclusive requirement to incinerate solid health-service waste, and
permits the use of other processes for final disposal, including autoclaving, chemical treatment,
radiation, microwave and sanitary landfill (septic trenches). It requires the Environment
Secretariat of the Office of the President of the Republic, in coordination with the Ministry of
HIealth (MS), the National Sanitationi Secretariat and the corresponding state and federal bodies,
to present to CONAMA, within 180 days, a proposal setting out minimun standards for the
treatment of solid waste other than by incineration



CONAMA Resolution 05/93
This decision requires the health establishment to take responsibility for managing its own waste
from the moment of generation until final disposal, in compliance with environmental and public
health requirements It calls for presentation of a Solid Waste Management Plan (PGRS) to be
approved by the environmental and health bodies. The plan would include recycling principles
and require entities that generate health-service waste to appoint a technical officer responsible
for managing the plan, duly registered in the Professional Council The Decision classifies
healthcare waste into the following four groups
Group A. Bio-waste and sharps,
Group B Chemical waste,
Group C Radioactive waste; and
Group D. Common waste materials.
It also defines appropriate conditions for containerization, transportation, treatment and final
disposal of waste materials In situations where segregation is not guaranteed, the Decision
requires all waste materials to be considered infectious except for special (Group B) and
radioactive (Group C) waste, whlich must always be separated.
Federal Law 9605 of February  This law makes actions harmful to the environment a criminal offence, and establishes
corresponding penal and administrative sanctions The dumping of solid, liquid or gaseous waste,
detritus, oils or oily substances, contrary to the requirements established in laws or regulations is
one of the actions sanctioned in the law
CONAMA Resolution No. 283, This decision aims to clarify, update and complement procedures contained in CONAMA No 5
of July 12, 2001              and establishes the following
•   The operating procedures to be used should be defined by the bodies comprising the
National Environment System and the National Sanitary Surveillance System
*   Liquid effluents from health service establishmiients should comply with the directives
established by the competent environmental bodies.
* Solid healtlh-service waste must be treated in systems, facilities and equipment that are
duly licensed by the environmental bodies and subject to periodic monitoring The
formation of consortia is supported
*   Chemical-hazard waste, including those arising from  chemotherapy and other
medications that are expired, altered, prohibited, partly used and unsuitable for
consumption, should be returned to the manufacturer or importer; these will be jointly
responsible for their handling and transportation
ABNT standards                 >   NBR 10004/87- Health-service waste - Classification in terms of environmental and public
health hazard
>   NBR 12807/93 - Health-service waste. Terminology
>   NBR 12808/93 - Health-service waste. Classification (this is at odds with CONAMA
Decisions 05/93 and 283/01, and therefore should not be used)
>   NBR 12809/93 - Handling of health-service waste Procedure
>   NBR 12 810/93 - Collection of healthcare waste Procedure
>   NBR 7500/00 - Symbols of hazards and the handling, transportation and storage of
materials
>   NBR 9191/00 - Specification of plastic sacks for containerizationi of solid waste
>   NBR 9190/85 - Classification of plastic sacks for containerization of solid waste.
>   NBR 13853/97 - Collectors for healthcare waste sharps Testing requirements and
methods.
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