DANIDA
DEAT Report Number: 12/9/6
NATIONAL WASTE MANAGEMENT STRATEGY
IMPLEMENTATION PROJECT, SOUTH AFRICA
THE REGULATION OF HEALTH
CARE WASTE IN SOUTH AFRICA –
AN ASSESSMENT OF THE NEED AND
OPTIONS FOR LAW REFORM
13 April 2006
NATIONAL WASTE MANAGEMENT STRATEGY
IMPLEMENTATION PROJECT, SOUTH AFRICA
THE REGULATION OF HEALTH
CARE WASTE IN SOUTH AFRICA –
AN ASSESSMENT OF THE NEED AND
OPTIONS FOR LAW REFORM
13 April 2006
Ref:
Report no:
Version no:
Date:
Jenny Hall/ NWMSI/HCW
03
Final
2006-04-13
Prepared by:
Checked by:
Approved by:
i
JH
KO, TK, TJ
PMG
TABLE OF CONTENTS
LIST OF ABBREVIATIONS ............................................................................................................. IV
1.
INTRODUCTION ........................................................................................................................... 1
2.
THE ROLE OF LEGISLATION IN SECURING SOUND HEALTH CARE WASTE
PRACTISES .................................................................................................................................... 2
3.
REVIEW OF NATIONAL LEGISLATION ................................................................................ 5
3.1
CONSTITUTION .......................................................................................................................... 6
3.1.1
Bill of rights ...................................................................................................................... 6
3.1.2
Allocation of functions ...................................................................................................... 7
3.2
WHITE PAPER ON INTEGRATED POLLUTION AND WASTE MANAGEMENT FOR SOUTH AFRICA,
2000 ........................................................................................................................................ 9
3.3
NATIONAL ENVIRONMENTAL MANAGEMENT ACT, 1998 ........................................................ 10
3.3.1
Principles ........................................................................................................................ 10
3.3.2
Planning ......................................................................................................................... 11
3.3.3
Environmental management ........................................................................................... 11
3.3.4
Compliance and enforcement ......................................................................................... 11
3.4
ENVIRONMENT CONSERVATION ACT, 1989 ............................................................................. 12
3.4.1
Waste management ......................................................................................................... 12
3.4.2
Environmental impact assessments ................................................................................ 14
3.4.3
Basel Convention on the Control of Transboundary Movement of Hazardous Wastes and
their Disposal, 1989 ...................................................................................................... 14
3.5
ATMOSPHERIC POLLUTION PREVENTION ACT, 1965............................................ 15
3.6
NATIONAL HEALTH ACT, 2003 ............................................................................................... 16
3.6.1
Health services ............................................................................................................... 16
3.6.2
Regulations for waste management ................................................................................ 17
3.7
HAZARDOUS SUBSTANCES ACT, 1977 ..................................................................................... 17
3.7.1
Regulation of Group IV substances ................................................................................ 18
3.7.2
Regulation of disposal .................................................................................................... 18
3.7.3
Application of the Act ..................................................................................................... 19
3.8
OCCUPATIONAL HEALTH AND SAFETY ACT, 1993 .................................................................. 19
4.
FINDINGS ..................................................................................................................................... 21
4.1
4.2
4.3
4.4
4.5
4.6
5.
INSTITUTIONAL ARRANGEMENTS ............................................................................................. 21
PLANNING ............................................................................................................................... 22
COLLECTION AND DISSEMINATION OF INFORMATION ............................................................... 23
DEFINITIONS AND CLASSIFICATION ......................................................................................... 23
REGULATION OF HEALTH CARE WASTE THROUGHOUT THE LIFE CYCLE .................................... 24
COMPLIANCE AND ENFORCEMENT ........................................................................................... 26
CONSIDERATION OF RECENT INITIATIVES THAT COULD BE USED AS A BASIS
FOR NATIONAL LEGISLATION ON HEALTH CARE WASTE ......................................... 28
5.1
GAUTENG HEALTH CARE WASTE MANAGEMENT REGULATIONS, 2004..................................... 28
5.1.1
General approach ........................................................................................................... 28
5.1.2
The use of permitting mechanisms .................................................................................. 29
5.1.3
Reporting mechanisms .................................................................................................... 29
5.1.4
Planning ......................................................................................................................... 30
5.1.5
Ambit of the regulations.................................................................................................. 30
5.1.6
Occupational health and safety matters ......................................................................... 30
5.1.7
Approach to drafting ...................................................................................................... 30
5.2
WESTERN CAPE HEALTH CARE WASTE MANAGEMENT BILL ..................................................... 32
5.2.1
General approach ........................................................................................................... 32
5.2.2
Imposition of responsibilities .......................................................................................... 32
5.2.3
Definitions ...................................................................................................................... 33
5.3
THE SANS CODE .................................................................................................................. 33
ii
5.3.1
5.3.2
5.3.3
5.3.4
6.
Accessibility and awareness of the code ......................................................................... 33
Incorporation of the codes in legislation ........................................................................ 33
Scope and comprehensiveness of the code...................................................................... 34
Compatibility with existing legislation ........................................................................... 34
RECOMMENDATIONS .............................................................................................................. 35
6.1
6.2
6.3
6.4
6.5
LEGISLATIVE OPTIONS FOR CREATING A REGULATORY FRAMEWORK ...................................... 35
SCOPE OF FUTURE HEALTH CARE WASTE LEGISLATION ............................................................ 37
STREAMLINING OF HEALTH CARE WASTE LEGISLATION WITH EXISTING
LEGISLATION .................................................................................................................... 37
SELECTING LEGISLATIVE MECHANISMS ................................................................................... 37
GEOGRAPHICAL AND RESOURCE CONSIDERATIONS .................................................................. 38
REFERENCES ..................................................................................................................................... 39
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LIST OF ABBREVIATIONS
DEAT:
DWAF:
DOH:
ECA:
EIA:
HBA
Regulations:
HCW:
IP & WM:
NEMA:
OHS Act:
Department of Environmental Affairs and Tourism
Department of Water Affairs and Forestry
National Department of Health
Environment Conservation Act, 1989
Environmental Impact Assessment
Hazardous Biological Agents Regulations, 2001
Health Care Waste
Integrated Pollution and Waste Management
National Environmental Management Act, 1998
Occupational Health and Safety Act, 1993
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1.
INTRODUCTION
The Department of Environmental Affairs and Tourism (“DEAT”) has initiated the
National Waste Management Strategy Implementation Project with the support of
DANIDA funding. As part of this project, DEAT has appointed Ms Jenny Hall of
environmental counsel cc to, inter alia, prepare a series of brief legislative analyses
which can be used to inform the drafting of particular aspects of waste management
legislation.
This document contains the legislative situation analysis for the health care waste
management component. It provides both a review of key legislation which regulates
health care waste as well as preliminary recommendations in respect of the
requirements for health care waste legislation.
In addition to this section, the document contains five sections. Section 2 of the
document discusses the role of legislation in a health care waste management system
as a basis for assessing the adequacy of the current legislative framework which is
summarized in section 3. Section 4 presents preliminary findings on the current
adequacy of the current legislation which is applicable to the management of health
care waste. Section 5 of the document considers three initiatives which have been
undertaken in respect of the management of health care waste with a view to
determining whether any of these documents can be used as a basis for developing
national health care waste legislation. Finally, section 6 presents the preliminary
recommendations and considerations for any future law reform initiatives that are
undertaken in respect of health care waste.
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2.
THE ROLE OF LEGISLATION IN SECURING SOUND
HEALTH CARE WASTE PRACTISES
In order for a comprehensive health care waste management system to be implemented
effectively, it is important that at least the basic requirements of the system are embodied
in legislation so that a framework is established in terms of which the rules of the health
care waste management system are clear, certain and accessible. Legislation also enables
the enforcement of the rules and facilitates the consistent application of these rules
pertaining to health care waste management. Legislation is therefore a key tool for the
effective implementation of a comprehensive health care waste management system.
For the purposes of this document, legislation is particularly important because it can



set out the institutional functions, responsibilities and powers of the different
levels of government;
establish the parametres and/ or requirements which must be adhered to when
managing health care waste; and
establish a basis for the consistent application of rules which are enforceable1.
Furthermore, since government is constrained to act within the parameters of law, it is
not possible for government to enforce the sound management of health care waste
without appropriate legislative provisions.
It is therefore important that any development of an approach to the regulation of
health care waste be developed with consideration being given to the role that such
legislation should play. In this regard, a brief review of approaches adopted by other
countries to the regulation of health care waste indicates that the certain
considerations influence the regulatory approach.
Most of the legislation reviewed incorporates the four steps of health care waste
management that are recommended by the World Bank2 i.e. segregation and storage,
transportation, treatment and disposal. This approach embodies the key components
of the life cycle.
Since the authority for managing all aspects of a life cycle approach usually lies with
several departments, the aspects that are incorporated directly in health care waste
legislation vary as it is often not possible to provide for a completely integrated
approach within one legislative instrument.
Many of the countries have opted to bring the key elements of the regulation of health
care waste within the ambit of environmental legislation.3 It is assumed that this has
been done to promote regulatory integration of waste management and in recognition
that public health care waste generators should not be both “referee and player”.4
1
Enforcement of legislation pertaining to health care waste that is generated by the public sector is less direct than
health care waste that is generated by the private sector because of, inter alia, the Constitutional requirements in
respect of co-operative governance.
2
Johannessen L, Dijkman M, Bartone, C, Hanrahan D, Boyer M and Chandra C, “Health Care Waste Management
Guidance Note”, World Bank, May 2000
3
See, for example, the Danish Environmental Protection Act, the New South Wales Waste Minimisation and
Management Act and the United Kingdom’s Environmental Protection Act.
4
See, for example,
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However, the institutional arrangements of the country influence the scope of the
legislation. For example, in the United States air emissions from incinerators used for
health care waste are separately regulated by the Clean Air Act. In New South Wales,
Australia, it appears that occupational health and safety issues are left to the realm of
the Occupational Health and Safety Act.
Where legislation is institutionally fragmented, co-operation is required to ensure that
health care waste is managed consistently and comprehensively. Examples of cooperation were identified in, for example, the Australian National Guidelines for the
Management of Clinical and Related Wastes5 which was produced by the National
Health and Medical Research Council. The guideline clearly indicates that the
responsibility for waste falls within the jurisdiction of the Sates and Territories and
reflects an attempt to provide a standardized national approach.
Some of the international legislation reviewed reflects a distinction in the regulatory
approach to large and small generators.6 This approach has, for example, been
adopted in the Californian Medical Waste Management Act. It is assumed that this
distinction is a reflection of the need to balance the impact of legislation on the
regulatory sector with the actual measures required for the protection of the
environment.
Irrespective of how these considerations are actually addressed in a country, the basic
elements of a health care waste management system which should be considered as a
framework for health care waste legislation are suggested in the diagramme below.
5
6
March 1999
This approach is also implied by the World Bank Guidance Note, op cit.
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GOVERNMENT MANAGEMENT MECHANISMS
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Institutional
arrangements
Mechanisms for
planning
Collection &
dissemination of
information
PROCEDURAL MECHANISMS
CONTROL MECHANISMS
Definitions
Regulation of the
life cycle of HCW
including –
generation
Storage
Collection and
transportation
Treatment
disposal
Compliance and
enforcement
General
Legislation must indicate which government authorities have
responsibilities for implementing and enforcing the legislation.
It must also provide for effective co-ordination. Additional
provisions regarding public consultation may be added.
Planning is an important component of a health care waste
management system as it can ensure the sustainability of the
system if conducted properly. Planning activities may include
approaches to ensuring that the required capacity of treatment
and disposal facilities will be sufficient, the management of
services to meet increased demands; and the introduction of
mechanisms to improve cost efficiency.
Information management is of paramount importance for, inter
alia, monitoring trends and the achievement of objectives,
reviewing standards and for planning purposes. The type of
information that may be required includes the significant
sources of waste generators, quantities and composition of
waste generated, rates of compliance and reports on progress
in achieving legislated or voluntary targets.
Coherent definitions are important for ensuring that the scope of
the legislation is clear. The lack of coherent definitions hinders
the implementation of a consistent approach to the
management of health care waste as well as the enforcement
of such legislation.
These provisions must establish the rules in terms of which health
care waste is managed throughout its life cycle. This may be
achieved by the introduction of permitting mechanisms and/ or
the imposition of requirements and standards. Issues may include
the conditions under which waste may be generated, the
requirements for storage and handling, the frequency of
collection and permissible treatment and disposal techniques.
Compliance and enforcement mechanisms must be included in
the legislation to ensure that compliance with the articulated rules
can be enforced. Both traditional command-and-control
approaches and other approaches should be considered for
inclusion.
The general provisions typically include administrative provisions
such as appeals, exemptions and administrative powers and
duties. Given the Constitutional and legislative imperative to
ensure that procedural rights are given effect to in the
implementation of legislation, it is preferable to also include
provisions regarding how these rights, including public
participation can be exercised.
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3.
REVIEW OF NATIONAL LEGISLATION
In South Africa, the regulation of waste in general is controlled by a plethora of
legislation, provincial ordinances and municipal by-laws. From research conducted by
the CSIR in 1991, it emerged that legislation regulating waste on land is dealt with in
thirty-seven Acts, sixteen provincial ordinances and numerous municipal by-laws.7
Since this time, several more pieces of legislation have been promulgated that have a
bearing on waste management, including the Constitution8, the National
Environmental Management Act9 and the National Water Act.10 Despite this
multitude of legislation, there is no single Act that regulates the disposal of waste in
its entirety. There is also no single national Act which regulates the management of
health care waste.
Legislation pertaining to the waste management is not only fragmented, but has also
been promulgated by different departments at all levels of government as part of the
general regulation of activities which fall within their jurisdiction and as a perceived
need arose. Waste management legislation has therefore been promulgated reactively
and in a piecemeal manner and a comprehensive and integrated waste management
system was not adopted. As a result, this legislation is both fragmented and lacks
cohesion.
The legislation that regulates waste may be broadly categorized as falling within the
following categories:





legislation aimed at regulating types of waste, for example, household waste,
effluent and nuclear waste;
legislation regulating waste produced by certain sectors, for example, mining;
legislation that regulates the destination of waste, for example, dumping at sea;
legislation that focuses on the potential health implications associated with
waste;11 and
legislation that has the protection of the environment as its primary focus.
The regulation of health care waste management straddles these categories as it is
found in legislation which is aimed at regulating sectors, such as the health sector,
legislation which focuses on managing the health implications of waste and
environmental legislation.
Legislation which contains health care waste management provisions may therefore
have different objectives. For example, legislation pertaining to health care waste that
is administered by the Department of Labour may be focused primarily on the
protection of workers whereas legislation which is administered by the Department of
Health may be focused on the protection of public health. Because of these different
objectives, current legislation controlling health care waste has not been drafted in a
Department of Environmental Affairs and Tourism, “The Situation of Waste Management and Pollution Control in
South Africa” report by the CSIR, 1991
8
Act No. 108 of 1996
9
Act No. 107 of 1998
10
Act No. 106 of 1998
11
Peckham B, “Some Thoughts on the Regulation of Hazardous Waste Disposal in South Africa” (1994) 1 SAJELP,
page 95
7
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way which ensures that the management health care waste is implemented in a coordinated and comprehensive manner.
The sections that follow provide a brief review of key national legislation which
regulates health care waste with the aim of determining the extent to which the
elements described in section 2 are currently provided for. It should be noted that
since health care waste emanating from nuclear processes and animals are excluded
from the scope of the national project, legislation regulating these matters is not
assessed. Furthermore, although there is a strong relationship between the treatment of
pathological waste and the cremation of human bodies, the latter is also not included
in the scope of the national project and is accordingly not dealt with in this report.
3.1
CONSTITUTION12
The Constitution is the supreme source of law in South Africa. It is relevant to this
review in two respects. Firstly, it contains an environmental right as well as certain
administrative rights, which provide the substantive mandate for waste management
regulation. Secondly, the Constitution provides the legal basis for allocating powers
to the different spheres of government and is therefore relevant to the institutional
arrangements that are established in respect of environmental issues in general and
health care waste management in particular. The Constitution accordingly sets the
broad framework for environmental governance.
3.1.1 Bill of rights
The environmental right is set out in section 24 of the Constitution. It provides that “Everyone has the right (a)
(b)
to an environment that is not harmful to their health or well-being; and
to have the environment protected, for the benefit of present and future
generations, through reasonable legislative and other measures that (i)
prevent pollution and ecological degradation;
(ii)
promote conservation; and
(iii)
secure ecologically sustainable development and use of
natural
resources while promoting justifiable economic
and social
development.”13
The environmental right can be divided into two components, namely, the right to a
clean and healthy environment and a positive obligation on government to pass
legislation to give effect to the right.
From the wording of the right, read together with other sections of Chapter 2 14, it is
clear that all organs of state are bound by the right and must give effect to it.
12
13
Act No. 108 of 1996
Section 24
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Furthermore, in giving effect to the right, the state must establish an effective
regulatory framework. Since poor health care waste practices can lead to pollution
and negative health effects, an effective waste management system for health care
waste will fall within the ambit of the right.
Other rights also impact on the way in which a health care waste management system
is structured and implemented. In this regard, government must structure its approach
to a health care waste management system in such a way that it incorporates the
procedural rights of the Constitution and, in particular, the rights pertaining to just
administrative action and access to information, (as amplified by the legislation
which has been promulgated to give effect to these rights).15 Examples of this
include the implications of these rights are that it must ensure that it has a system for
providing information requested in terms the Access to Information Act16 and that
officials exercise their functions in accordance with the Promotion of Administrative
Justice Act.17
Much of the legislation regulating health care waste has been promulgated prior to
the adoption of the Constitution. In some instances there may accordingly not be a
proper alignment between the provisions of the Acts and the requirements of the
Constitution.
3.1.2 Allocation of functions
The second issue of significance is that the Constitution provides a framework for
governance based on the concept of co-operative government, the principles of which
are set out in chapter 3. This has implications for the way in which information and
communication activities are structured and/or the participation by the different
spheres of government in existing (and future) structures and processes that are
established for the purpose of facilitating co-operative governance. For example,
government departments should liaise with other government departments regarding
the implementation of waste management matters falling within each other’s
competence.
In addition to the imperative of co-operative governance, the Constitution delineates
authority and responsibility for specified functional areas to the different spheres of
government. Each sphere of government has the right, subject to the Constitution, to
assign responsibilities for a for which it has competence to departments within that
sphere of government. For example, at the national level of government, four
departments have the potential to play a role in the management of health care risk
waste, namely, the Department of Environmental Affairs and Tourism , the
Department of Health, the Department of Labour and the Department of Agriculture
and Land Affairs.
This delineation of functions is set out in Schedules 4 and 5 of the Constitution.
Functional areas of concurrent national and provincial competence are set out in
14
For example, sections 7 and 8
Promotion of Administrative Justice Act and the Access to Information Act.
Act No. 2 of 2000
17
Act No. 3 of 2000
15
16
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Schedule 4 of the Constitution and the functional areas of exclusive provincial
competence are set out in Schedule 5. Each Schedule is broken down into Part A and
Part B. Part B sets out matters that fall within the jurisdiction of local government. In
other words, local government has the executive authority and right to administer
matters listed in Part B and, may pass by-laws in respect of these matters. (Such bylaws must be compatible with any relevant national and provincial legislation. If they
conflict with national or provincial legislation, they will be invalid).
The list of functions set out in Part B is made subject to the provisions of section
155(6)(a) and (7). In terms of these sections, provincial government is responsible for
taking effective measures to provide for the monitoring and support of local
government in the province. The other spheres of government also have the
legislative and executive authority to see to the effective performance of functions by
municipalities by regulating the exercise of the local government’s executive
authority discussed above.
The functional areas of potential relevance to this review are set out in the table
below.
Schedule 4
Part A
Part B
 Environment
 Health
services
 Pollution
control
 Air pollution
 Municipal
health services
Schedule 5
Part A
 Abattoirs
 Veterinary services,
excluding regulation of the
profession
Part B
 Control of public
nuisances
 Cemeteries, funeral
parlours and crematoria
 Facilities for the
accommodation, care and
burial of dead animals
 Municipal abattoirs
 Refuse removal, refuse
dumps and solid waste
disposal
The allocation of functions reflected in the table above indicates the following –



The Constitution has not changed the fact that the administration of health care
waste legislation as well as the promulgation of associated legislation will
remain within the jurisdiction of several different government departments at
different levels of government. The establishment of an integrated system for
health care waste management is therefore challenging because of the split in
regulatory responsibilities.
Because of the involvement of different government departments, at all levels
of government, it is imperative that these departments co-ordinate effectively
to ensure that the health care waste management system is comprehensive in
both the content and implementation thereof.
The wording of certain of the local government functions may have
implications for the structuring of health care waste legislation. For example,
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
3.2
“facilities for the accommodation, care and burial of dead animals” may be
interpreted as meaning that the landfilling of animal carcasses or the
emergency disposal of animals in the event of an outbreak, are issues which
fall within the competence of local government.
The areas of competence may cause some confusion regarding the
responsibility for waste management. For example, in terms of Schedule 5
“refuse removal, refuse dumps and solid waste disposal” are listed in Part B
i.e. they should be administered by local authorities. However, other aspects of
control that may impact on health care waste management, such as the
environment itself and pollution control, are listed as Schedule 4
competencies. (This matter may be addressed to some extent by section 146 of
the Constitution which contains an override clause providing that the national
sphere of government may pass legislation if it is necessary, inter alia, to
protect the environment).
WHITE PAPER ON INTEGRATED POLLUTION AND WASTE
MANAGEMENT FOR SOUTH AFRICA, 200018
Although not legislation per se, a discussion of the White Paper on Integrated
Pollution and Waste Management (“the White Paper”) is included in this section since
it sets out the vision, principles, strategic goals and objectives that government will
use to achieve integrated pollution and waste management in South Africa.
The White Paper reflects a paradigm shift in the way in which pollution and waste
will be managed based on the following concepts 




pollution prevention;
waste minimization;
cross-media integration;
institutional horizontal and vertical integration of departments and spheres of
government; and
involvement of all sectors of society in pollution and waste management.
The policy reflects government’s intention to move away from a situation of
fragmented and uncoordinated pollution control and waste management to one of
“integrated pollution and waste management” i.e. a holistic and integrated system and
process of management aimed at pollution prevention and minimization at source,
managing the impact of pollution and waste on the receiving environment and
remediating damaged environments. Seven interdependent strategic goals have been
identified for achieving this overarching goal.
The concepts and goals articulated in the White Paper should accordingly be used as a
benchmark for assessing the appropriateness of current legislation as well as the
approach which should be adopted in the approach to future legislation.
18
Government Gazette No. 20978, 17 March 2000
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NATIONAL ENVIRONMENTAL MANAGEMENT ACT, 199819
3.3
The National Environmental Management Act (“NEMA”) was promulgated to give
legislative effect to the provisions of the White Paper on a National Environmental
Management Policy for South Africa.20 The Act provides for co-operative
environmental governance by establishing principles for decision-making on matters
affecting the environment, institutions that will promote co-operative governance and
procedures for co-ordinating environmental functions exercised by organs of state. The
Act therefore also gives effect to the obligations relating to co-operative government
contained in section 42 of the Constitution.
Because of the broad scope of the Act, it is arguable that most of its provisions are
applicable to health care waste management. However, this review refers only to the
more significant provisions.
3.3.1
Principles
Section 2 of the Act contains a set of principles. There are two overarching principles,
namely that 

environmental management must prioritize people and serve their interests
equitably (i.e. an anthropocentric approach); and
development must be socially, environmentally and economically sustainable
(i.e. sustainable development).
Subsection 4 sets out a number of factors that must be taken into account when
assessing sustainable development as well as a list of what may be regarded as “subprinciples.” The “sub-principles” may be viewed as providing content to the two main
principles as well as an indication on how the latter should be operationalised. The
“sub-principles” include most of those contained in the White Paper on Environmental
Management such as “polluter pays”, “integration”, “environmental justice” and
“participation”.
Section 2 provides that the principles apply to all the actions of all organs of state that
may have a significant impact on the environment. Such actions will include the
drafting of legislation, formulation of policy and strategy, granting of authorizations
and other decision-making. In other words, the application of the principles should
occur in all aspects of health care waste management by government. The principles
must therefore be considered in the approach which is developed to health care waste
management legislation.
19
20
Act No. 107 of 1998
May 2000
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3.3.2 Planning
NEMA requires certain departments and all the provinces to prepare environmental
management plans or environmental implementation plans. (Local government is
obliged to give effect to the environmental implementation plan which is prepared by
the relevant province). The purpose of these plans is to 




co-ordinate and harmonize the environmental policies, plans and decisions of
the various national departments, provinces and local government which
exercise functions that may effect the environment;
minimize duplication and promote consistency;
secure the protection of the environment across the whole country;
prevent unreasonable actions by provinces; and
to enable the Minister to monitor the achievement, promotion and protection
of a sustainable environment.21
The approach to planning set out in the Act therefore potentially facilitates the coordination of health care waste management plans, policies and legislation.
3.3.3
Environmental management
Chapter 5 provides for the development of tools and permitting systems to manage the
impact of activities on the environment. New national environmental impact
assessment (“EIA”) regulations, including a list of identified activities to which the
regulations apply, are in the process of being finalized. The draft list, which was
published for initial comment during 2004 includes various activities related to waste
management, including the handling, treatment and disposal of waste. (Incineration
will also be brought within the ambit of the regulations by virtue of a listing in the
National Air Quality Management Act, 2004).22 Although some further amendments
will be made to the list before it is finalized, it is likely that the more expansive
approach to the regulation of health care waste activities will be retained.
Once these regulations have been passed, any person wanting to undertake an activity
that is identified in the list will require an environmental authorization from the
relevant government department, known as the competent authority. The regulations
provide a potentially useful tool for the regulation of health care waste facilities since
the authorization process takes all environmental aspects into account. Aspects of the
life cycle which are sometimes not addressed in other legislation can accordingly be
caught within the net of the EIA decision-making process.
3.3.4
Compliance and enforcement
NEMA has recently been amended to provide for expansive compliance and
enforcement powers. These powers are applicable to any Act which is identified in
21
22
Section 12
Act No. 39 of 2004
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NEMA. Although the powers do not expressly relate to health care waste
management, any future health care waste legislation could be linked to this chapter
in NEMA.
3.4
ENVIRONMENT CONSERVATION ACT, 198923
The Environment Conservation Act (“ECA”) is presently recognised as the most
important Act governing waste - particularly solid waste - since, unlike most other
legislation regulating waste, it makes provision for the regulation of waste specifically
and with the aim of providing for the protection of the environment. Although much
of the Act has been repealed by NEMA, the sections pertaining to waste,
environmental impact assessments and regulatory powers are still in effect. These
provisions are discussed in more detail below.
3.4.1
Waste management
In the past both the Department of Water Affairs and Forestry (“DWAF”) and DEAT
administered the waste management provisions of ECA. An amendment to the Act
has recently been drafted to transfer the management of the disposal of waste from
DWAF to DEAT. This amendment has been in operation since January 2006. All
key aspects of waste management provided for in ECA are now regulated by DEAT
or the provinces.
Section 1 of ECA provides for the formulation of a definition of waste by regulation.
A regulation setting out such a definition24 was passed in 1990. In terms of the
regulation, waste is accordingly defined as an undesirable or superfluous by-product,
emission, residue or remainder of any process or activity, any matter, gaseous, liquid
or solid or any combination thereof originating from any residential, commercial or
industrial area, which is discarded by any person, is accumulated and stored by any
person with the purpose of eventually discarding it with or without prior treatment
connected with the discarding thereof, or which is stored by any person with the
purpose of recycling, re-using or extracting a useable product from such matter.
Although the definition excludes certain types of waste, health care waste is not one
of the exclusions and it is accordingly clear that health care waste falls within the
scope of the Act.
The main requirements of ECA pertaining to waste are contained in section 20 which
provides that “subject to the provisions of any other law, no persons shall discard waste or
dispose of it in any manner, excepta) at a disposal site for which a permit has been issued in terms of
subsection (1);
23
24
Act No. 73 of 1989
GNR 1986, GG 12703, 24 August 1990
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b) in a manner or by means of the facility or method in
subject to such conditions as the Minister may
prescribe.”25
This section also provides that “no persons shall establish, provide or operate any disposal site without a
permit issued by the Minister of Environmental Affairs and Tourism.” 26
ECA accordingly places an obligation on both generators of health care waste, to
ensure that their wastes are disposed of appropriately, and waste operators, to handle
such disposal in accordance with permit provisions.
A series of documents called the Minimum Requirement Series was published by the
Department of Water Affairs and Forestry in 1994. These documents aim to establish
a framework of standards for the disposal of waste. The aim of these standards is to
ensure the sustained fitness for use of South Africa’s water resources and to protect
both the public and the environment from the harmful effect of incorrect waste
management.
The Minimum Requirements provide the norm by means of which authorities, waste
generators, permit holders and other interested and affected parties can differentiate
acceptable waste handling and disposable practices from unacceptable practices.
They are also a practical indication of how the Minister’s discretion regarding to
approval of permits for waste sites will be exercised.
The requirements contained in the documents are currently being enforced by means
of conditions in permits for waste disposal sites. In future they will also be used in
respect of the registration of waste generators and transporters and manifest systems.
A new draft was has recently been published which is due to be finalized in the near
future.
In addition to the provisions of section 20, the Act allocates powers to both the
Minister of Water Affairs and Forestry and the Minister of Environmental Affairs
and Tourism to pass regulations which expand the reach of the waste management
provisions, although to date very few regulations have been passed in terms of the
Act.27
The absence of national regulations means that the potential for ECA to provide an
effective and integrated management system for health care waste has not been
realized. Health care waste is accordingly not specifically regulated under the Act
with the exception of the Gauteng Regulations for Health Care Waste Management .
25
Section 20(6)
Section 20(1)
Regulations that have been passed include those for waste disposal site permit applications (GNR 11196, GG
15832, 8 July 1994).
26
27
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3.4.2
Environmental impact assessments
Until the NEMA EIA regulations are passed, the ECA requirements 28 to obtain
authorization for the undertaking of identified activities after conducting an EIA
process remain in force. Waste disposal activities fall within the list of identified
activities for which an EIA is required. Both activities which require a permit in terms
of section 20 of the Act as well as activities which require a registration certificate in
terms of the Atmospheric Pollution Prevention Act, 1965,29 fall within the scope of the
listed activities. Authorization is therefore required prior to the construction, upgrade,
expansion or operation of any new disposal facilities – including incineration facilities
– for the treatment or disposal of health care waste.
3.4.3
Basel Convention on the Control of Transboundary Movement of
Hazardous Wastes and their Disposal, 1989
South Africa ratified the Basel Convention in 1994.
interdependent goals namely -
The Convention has three
 transboundary movement of hazardous waste should be reduced to a minimum
consistent with environmentally sound management principles;
 hazardous waste should be treated and disposed of as close as possible to the
source of their generation; and
 hazardous waste should be reduced and minimized at source.
Wastes which fall within the ambit of the Convention include any waste which falls
within a category contained in Annexure 1, unless the waste does not possess any of
the characteristics contained in Annexure 3. Health care waste falls within the scope
of the Convention.
As a party to the Convention, the key obligations which South Africa has accepted are
the following –




28
29
no waste may be imported from a country listed in Annex VII i.e. a developed
country;
transboundary movement of hazardous waste is permitted between developing
states where it presents the best solution for the environment, or if it takes
place in conformance with the Convention e.g. exportation may occur if the
state of export does not have the technical capacity or facilities to dispose of
hazardous waste in an environmentally sound manner, or possibly if the waste
is required as raw material for recycling in the state of import or in accordance
with additional criteria to be determined by the states;
hazardous waste may not be exported to or imported from a non-party unless a
bilateral agreement has been entered into with South Africa;
transboundary movement of hazardous waste is not to be permitted to parties
that have prohibited the import of such waste;
Sections 21 and 22 and GNR 1182 & 1183, September 1997
Act No. 45 of 1965
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





hazardous waste and other waste may not be exported or imported unless the
state of import provides consent in writing for the specific import;
hazardous waste and other waste that is to be subject to transboundary
movement must be packaged, labelled and transported in conformity with
generally accepted and recognised international rules and standards in the field
of packaging, labelling and transport, and that due account is taken of relevant
internationally recognised practices;
hazardous waste and other waste must be managed in an environmentally sound
manner and this obligation may under no circumstances be transferred to other
states of import or transit;
appropriate measures must be taken to ensure that the generation of hazardous
waste and other waste is reduced to a minimum, taking into account, inter alia,
technological and economic aspects;
there must be adequate disposal facilities; and
appropriate legal, administrative and other measures to implement and enforce
the provisions of the Convention, including measures to prevent and punish
conduct in contravention of the Convention.
The Convention is administered by DEAT although the Department of Trade and
Industry administers the permitting provisions relating to the import and export of
waste in conjunction with DEAT. Although the Convention itself has been published in
the Government Gazette in terms of ECA, South Africa has not passed legislation
pertaining to the transboundary movement of hazardous waste as is required in terms of
the Basel Convention. In other words, no regulations in respect of the administration of
the Convention have been passed and the management of the transboundary movement
of waste from an environmental perspective is accordingly under-regulated.
ATMOSPHERIC POLLUTION PREVENTION ACT, 196530
3.5
The Atmospheric Pollution Prevention Act is due to be repealed and replaced by the
National Air Quality Management Act in its entirety. However, at present certain
provisions which are still in force are relevant to health care waste.
In this regard, Part II of the Act makes provision for two permitting procedures in
respect of scheduled processes in areas that have been declared to be controlled.
These are provisional registration certificates and registration certificates. (In terms
of Government Notice R1776, dated 4 October 1968, the whole of the Republic has
been declared as a controlled area).
One of the scheduled processes is relevant to health care waste, namely 
30
31
“Waste incineration processes: That is to say, processes for the destruction by
incineration of waste that contains chemically bonded halogens, nitrogen,
phosphorus, sulphur or metal, or any other waste that can give rise to noxious
or offensive gases” 31.
Act No. 45 of 1965
Process no. 39
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Any person who wants to conduct one of these activities, or who intends erecting or
causing any building or plant to be erected or who intends altering or extending or
causing any existing building or plant to be altered or extended for the purpose of
carrying out one of these processes must obtain a provisional registration certificate.32
The provisional registration certificate is not required where the proposed building or
alteration will not affect the escape into the atmosphere of noxious or offensive gases.
DEAT has published Guidelines for the Control of Air Pollution, as well as
Guidelines for the Operation of Incinerators. These guidelines are not of legislative
force, but are often used by the Department in determining appropriate conditions
when granting certificates. The absence of updated and legally binding guidelines has
been a source of criticism and has been blamed for the poor performance standards
some of incinerators.33
3.6
NATIONAL HEALTH ACT, 200334
The primary aim of the National Health Act is to establish a framework for the
management of health services. The Act does not use the term “health care waste” but
contains two direct references to waste namely, the definition of “municipal health
services” includes waste management35 and the provisions setting out the powers of
the Minister to make regulations include the power to make regulations in respect of
medical waste.36 “Medical waste” is not defined. The terminology used in the Act,
particularly without the inclusion of a definition, may cause some terminology
alignment problems with other legislation.
The relevant provisions of the Act are discussed in more detail below.
3.6.1
Health services
The Act stipulates that municipalities must provide appropriate municipal health
services in their areas of jurisdiction which are equitable and affordable.37 The
implication of the inclusion of waste management within the definition of municipal
health services means that the provision of these services includes the management of
health care waste.
However the obligation to provide health services contains a subjective element
because of the inclusion of the word “appropriate.” The Act does not provide
assistance in establishing what would constitute an appropriate waste management
service since no detailed provisions regarding health care waste management are
included in the Act. In the absence of further regulations or guidance, the
determination of what constitutes an appropriate waste management service will
32
Section 9
See for example the comments made in the technical documents produced as part of the National Waste
Management Strategy Implementation Project
34
Act No. 61 of 2003
35
Section 1
36
Section 90(1)(n)
37
Section 32(1)
33
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therefore be left to the discretion of the municipality. In its current form the Act has
therefore not created a uniform management system for health care waste.
It is noted that apart from the provision of services by municipalities, the Act also
provides that provincial governments must provide “specialized hospital services”.38
Unlike municipal health services, this term is not defined and there is no direct
reference to specialized hospital services including waste management. There is
accordingly a potential difference in approach which has been adopted between
municipalities and provinces.
3.6.2
Regulations for waste management
As indicated above, the Minister has powers to pass regulations in respect of waste
management. The power to set rules is also implicit in other sections of the Act. For
example, the Director-General of the national department must issue and promote
compliance with certain norms and standards, including in respect of environmental
conditions that constitute a health hazard.39
Because of the recent commencement of the Act, these powers have not been used
yet. It is noted that extensive draft regulations in respect of health care waste
management were published for comment in terms of the Health Act, 1977.40 It is not
known whether the Department intends finalizing these regulations under the National
Health Act.
3.7
HAZARDOUS SUBSTANCES ACT, 197741
The Hazardous Substances Act, which is administered by the Minister of Health,
provides for the control of substances that may cause injury, ill-health or death to
human beings by reason of the substance being toxic, corrosive, irritant, strongly
sensitising, flammable or because these effects can occur through the generation of
pressure. Although a primary purpose of the Act is not to regulate waste management,
it contains specific powers regarding the regulation of the “disposal” of hazardous
substances.
38
Section 25(2)(a)
Section 21(2)(b)(ii)
GG 6715, GNR 21, 2000
41
Act No. 15 of 1977
39
40
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3.7.1
Regulation of Group IV substances
The primary mechanism for exercising control over hazardous substances is the power
of the Minister to declare substances to fall within one of four specified groups of
hazardous substances. Once a group is declared, regulations controlling various
aspects of their handling can be promulgated by the Minister. For the purposes of this
review, Group IV is significant. Group IV hazardous substances are defined as
meaning radioactive material which is outside a nuclear installation as defined in the
Nuclear Energy Act No. 131 of 1993, and is not a material which forms part of, or is
used, or intended to be used, in the nuclear fuel cycle, and –
“(a)
(b)
has an activity concentration of more than 100 becquerels per gram and a
total activity of more than 4 000 becquerels; or
has an activity concentration of 100 becquerels or less per gram or a total
activity of 4 000 becquerels or less and which the Minister has by notice in the
Gazette declared to be a Group IV hazardous substance,
and which is used or intended to be used for medical, scientific, agricultural,
commercial or industrial purposes, and any radioactive waste arising from
such radioactive material.” [Emphasis added]
The Group IV substances are regulated by means of a licensing regime, although the
licensing requirements do not apply to any Group IV hazardous substances with a
total activity of 4 000 becquerel or less, and more than 4 000 becquerel but less than
the maximum activity indicated in regulations passed by the Minister where such
substance forms part of a device indicated to such maximum activity, except in the
case where such device is manufactured in or imported into the Republic.42
Where the activity falls within the scope of the licensing regime, written permission
must be obtained from the Director-General to produce or otherwise acquire, dispose
of, import or export, be in possession of, use, convey or cause to be conveyed, a
Group IV hazardous substance. Regulations have been passed43 which specify the
requirements in respect of license applications. In addition to license application
requirements, the regulations set out a range of conditions which apply to all holders
of Group IV licenses, in addition to any conditions which may be imposed by the
Director-General. These include requirements in respect of the development of
internal rules, storage, disposal, accidents and incidents and emergency planning.
3.7.2
Regulation of disposal
In addition to the control of waste through licensing provisions, provision is also
made in terms of section 29 of the Act for regulations to be passed controlling the
dumping and disposal of hazardous substances. Section 29 empowers the Minister to
make regulations regarding, inter alia -
42
43
Regulation 246 of 26 February 1993
GN Regulation 247 of 16 February 1993
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


the authorizing, regulating, controlling, restricting or prohibiting of the
manufacture, modification, importation or storage, transportation or dumping
and other disposal of any grouped hazardous substances or class of grouped
hazardous substance;
prescribing precautions to be taken for the protection from injury, ill health or
death of persons in control of or employed in the manufacture, operation,
application or use of hazardous substances or as the result of the manufacture,
operation, application, use, disposal or dumping thereof; and
safety standards in connection with the importation into and exportation from
the Republic, manufacture, packing, disposal, dumping, sale, serving,
applying, administering or use of declared hazardous substances.
These powers have not been extensively used and the absence of regulations has
undermined the potential of the Act to provide a life cycle approach to the
management of hazardous substances, including resulting waste.
3.7.3
Application of the Act
An interesting provision of the Act is the potential extension of the application of the
provisions of the Act. In terms of section 30, the Minister may at the request of the
government or administration of a country outside South Africa apply any provision
of the Act to any grouped hazardous substance which arrives at, or is imported
through, an import harbour or other place in the Republic and which is intended for
transmission to a place in that country. (“Grouped hazardous substance” in this
context means any Group IV hazardous substance and any substance, mixture of
substances, product or material declared in terms of the Act to be a hazardous
substance of any kind).
OCCUPATIONAL HEALTH AND SAFETY ACT, 199344
3.8
The Occupational Health and Safety Act (“OHS Act”) is the primary law regulating
health and safety matters. It covers all sectors except mining and merchant shipping.
Notwithstanding this, the Act has overlapping or joint jurisdiction in some areas such
as railways where safety is also regulated by the Railway Safety Regulator Act,
2002,45 and the investigation of traffic accidents which are excluded from the Act and
covered by transport legislation.46
The OHS Act is a framework Act which provides for the development of detailed
rules and standards through regulation. It provides for 
an extensive framework of duties upon employers and employees (and also
suppliers);

co-operative structures for employees and employers to engage on
occupational health and safety issues; and
44
Act No. 85 of 1993
Act No. 16 of 2002
46
Section 24
45
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
supervisory and enforcement mechanisms.
Specific regulations on hazardous biological agents (“HBA”) have been passed in
terms of the Act.47 The regulations apply to every employer at a workplace where
HBA are deliberately produced, processed, used, handled, stored or transported or
to an incident which occurs and which does not involve a deliberate intention to
work with a HBA, but may result in persons being exposed to HBA in the
performance of his or her work.48
The regulations follow a similar format to other regulations passed under the Act
and contain provisions in respect of information and training which must be given
to employees, duties of persons who might be exposed to HBA, risk assessments
and medical surveillances which must be undertaken, records to be kept, the
furnishing of protective clothing and the labeling, transportation and storage of
HBA. The regulations also contain a provision on the disposal of HBA,49 namely
that –

written procedures must be developed by the employer for
decontamination, disinfection and for the handling and disposal of HBA
waste without risk;

HBA waste must be disposed of only on sites designated for the purpose
in terms of ECA;

protective clothing must be provided; and

where a contractor is used, a contract must be entered into with the waste
disposal contractor obliging the contractor to adhere to the regulations.
The regulations do not reference the EIA Regulations which may deal with the
disposal or treatment of the waste.
47
GG 22956, GNR 1390, 27 December 2001
Regulation 2
49
Regulation 17
48
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4.
FINDINGS
4.1
INSTITUTIONAL ARRANGEMENTS
The powers and responsibilities for the administration of legislation pertaining to
health care waste lies with several Ministers and departments at all spheres of
government. The different responsible authorities and the basis of authority are
summarized in the table below together with some comments on the contribution of
the legislation to a health care waste management system.
Responsible
authority
Minister of Health
&
Department of
Health
Relevant mandate
Legislation
Public health and health
services
National Health
Act;
Hazardous
Substances Act
Minister of
Environment
&
Department of
Environmental
Affairs and Tourism
Protection of the
environment
Environment
Conservation Act;
Atmospheric
Pollution
Prevention Act;
Air Quality
Management Act;
National
Environmental
Management Act
Minister of Labour
&
Department of
Labour
Protection of worker
health and safety
Occupational
Health and Safety
Act including the
HBA Regulations
Comments
Power to make
regulations on
medical waste may
be an overlap with
the powers of the
Minister of
Environmental
Affairs and
Tourism.
The term “medical
waste” is used as
opposed to HCW
and is not defined.
No national
regulations passed
specifically in
respect of health
care waste. The
proposed National
Waste Bill and
regulations under
the Air Quality
Management Act
will encompass
aspects of health
care waste.
The regulations
contain detailed
provisions
regarding, inter alia,
the handling of
HBA substances.
Disposal is linked to
the ECA and
Atmospheric
Pollution Prevention
Act. Any
regulations or
standards that are
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Responsible
authority
Relevant mandate
Legislation
Comments
developed in terms
of the National
Health Act will need
to be aligned with
these regulations.
Minister of
Agriculture
&
Department of
Agriculture
Provincial
departments
Regulation of animal
health
Excluded from the
ambit of this report
Concurrent responsibility
for the protection of the
environment
Some provincial
departments have
passed regulations
in respect of HCW
Local authorities
Constitutional
responsibility for air
pollution, municipal
health services, control of
public nuisances,
cemeteries, funeral
parlours and crematoria,
facilities for the
accommodation, care and
burial of dead animals,
municipal abattoirs and
refuse removal, refuse
dumps and solid waste
disposal
4.2
Provincial
legislation will need
to be aligned with
any national
legislation that is
promulgated
By-laws not
By-laws will need to
reviewed as part of be aligned with any
this project. It is
national legislation
noted however, that that is promulgated
several
municipalities have
by-laws which
include provisions
regarding the
management of
HCW
PLANNING
As indicated in section 2, planning is a key mechanism in the management of health
care waste since it can be used to ensure the sustainability of a health care waste
management system. In this regard, planning may be undertaken by the regulator as
well as the regulated community.
With regards to planning initiatives by the regulator, the legislation reviewed contains
at least two planning provisions which can be used in respect of health care waste. In
this regard, NEMA requires the submission of environmental management plans and/
or environmental implementation plans and the National Health Act imposes
obligations on the different spheres of government to undertake health planning,
which could include planning in respect of health care waste management. In the case
of district and metropolitan health systems, a district health plan must be prepared.50
50
Section 33
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With regard to the regulated sector, the HBA regulations passed in terms of the OHS
Act and the Group IV substances regulations passed in terms of the Hazardous
Substances Act require an employee to develop a range of written procedures or rules
which can be considered to constitute a form of “micro” planning. Apart from this,
mechanisms to ensure the proactive planning of health care waste management by the
regulated sector are only found indirectly in the legislation.
4.3
COLLECTION AND DISSEMINATION OF INFORMATION
The collection, dissemination and management of information provides a basis of
knowledge which is of paramount importance for, inter alia, monitoring the
implementation of a health care waste management system, reviewing the standards
which are set and for planning purposes. Information is also important because the
quantity and composition of wastes generated may change, especially where there is
rapid urbanization, as well as the fact that certain activities are empirical and do not
necessarily conform to theoretical solutions. It is therefore necessary to ensure that
there are legislative powers to secure the collection of relevant data and/ or
information and the processing thereof.
Recognition of the need to collect information is reflected in both the White Paper as
well as the National Waste Management Strategy. The establishment of a waste
information system is also one of the outputs of the National Waste Management
Strategy Implementation Project. Although there are certain legislative requirements
in respect of information, such as the HBA regulations which provide that records of
all assessments, monitoring results and medical surveillance reports must be kept,51
the objective of the White Paper has not yet been translated into legislation and there
is currently no general legislative framework for the collection of information in
respect of health care waste.
This is considered to be a key gap in the current legislative framework since the
absence of such provisions make it difficult for government to obtain verifiable
information regarding the quantity and composition of health care waste which is
generated as well as information on how the waste is being disposed of. This in turn
will impede accurate planning as well as the implementation of compliance and
enforcement initiatives.
4.4
DEFINITIONS AND CLASSIFICATION
The legislation does not have a consistent approach to the use of definitions in respect
of health care waste.
In addition to this, the legislation potentially provides for different classification
methods as, for example, some legislation is based on SANS 10228 and other Acts
51
Regulation 9
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have their own systems - such as the Hazardous Substances Act which provides for
the grouping of substances into one of four categories.
4.5
REGULATION OF HEALTH CARE WASTE THROUGHOUT THE
LIFE CYCLE
A summary of how the current legislative matrix relates to the life cycle of health care
waste is set out in the table below. (Waste minimisation and use is not included in the
table since these aspects are considered to have limited applicability to health care
waste).
Act
Generation
Atmospheric
Pollution
Prevention Act
Provisional
and/ or final
registration
certificate
required
Requirement
to undertake
an
environmental
impact
assessment
and to obtain
authorization
prior to
undertaking
certain
activities,
including in
respect of
hazardous
substances.
Provision will
have limited
application to
health care
waste
Environment
Conservation
Act –
 Waste
provisions;
 EIA
requirements;
 Basel
Convention
Hazardous
Substances Act
Licenses
required for
Group IV
substances waste
regulated
through
permit
conditions
Storage
May be
addressed in
registration
certificate
Not expressly,
but sometimes
dealt with
through
permitting
requirements
Storage of
Group IV
substances
regulated by
regulations –
may not apply
to HC waste
Transporta
tion
X
Disposal
Importation
and
exportation
of waste
may be
controlled
by
regulation;
South
Africa is a
party to the
Basel
Convention
which
includes
HCW
(permitting
required in
terms of
Import and
Exports
Act)
Importation
or
exportation
of Group IV
substances
requires
permission;
Provisions
of the Act
Permits required to
operate waste
disposal facilities;
waste may only be
disposed of in
permitted facilities
EIA authorization
required for the
establishment of
disposal facilities
X
Group IV waste
regulated through
license conditions
and regulation
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Act
Generation
Storage
Transporta
tion
apply to
substances
in transit on
request of
another
country;
X
X
Not specific
requirements at
present. Duty of
care will be
applicable to the
management of
health care waste;
Public sector
institutions will be
obliged to take
principles into
account
Regulatory
power – no
specific
provisions
Drivers to
be trained
and waste to
be labelled
Regulatory power –
no specific
provisions
and regulation
National
Environmental
Management
Act
Not specific
requirements
at present.
Duty of care
will be
applicable to
the
management
of health care
waste;
Public sector
institutions
will be
obliged to
take
principles into
account
National Health Regulatory
Act
power – no
specific
provisions
Occupational
X
Health and
Safety Act
National Road
Traffic Act
Regulatory
power – no
specific
provisions
Duty to
ensure that
waste is
properly
stored and
controlled to
prevent the
spread of
infection
Disposal
Work procedures to
be introduced;
Reference is made
to the requirements
of the Environment
Conservation Act
and Atmospheric
Pollution
Prevention Act
Comprehens
ive
provisions
including
the need for
drivers to be
trained and
waste to be
labelled
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The analysis of the legislation in the previous section of this report and the summary
of this legislation regarding how it relates to the life cycle of health care waste
reflected in the table above indicates that the legislative matrix currently does not
provide for the detailed and comprehensive management of health care waste
throughout its life cycle. In this regard, the following problems are noted –
4.6

The emphasis of the substantive legislative provisions is on the treatment and
disposal of the waste i.e. the legislation has an end-of-pipe focus.
Notwithstanding this, there are no enforceable standards in respect of, inter
alia, incineration and non-thermal treatment technologies that are inadequate
to ensure that negative environmental or health impacts are mitigated to
acceptable levels.

The consequence of the focus on disposal is that other aspects of the life cycle
are managed indirectly by means of permitting systems which are not overtly
intended to be applied to these aspects, or not at all. In this regard, there is
generally an absence of specific control or legislative clarity – whether by
means of registration mechanisms, permitting requirements or the imposition
of standards - over certain aspects of the life cycle such as segregation,
storage, labelling and spillages. (The Hazardous Substances Act and OHS Act
regulations provide some detail in respect of certain aspects of the waste
stream).

Although the current legislation probably contains enough enabling provisions
for the passing of regulations which could address the deficiencies identified
above, these provisions have not been utilised. Notwithstanding this, care
would have to be taken when passing any such regulations to ensure that there
is no conflicts or double regulation with other legislation.(In this regard,
legislation which has been adopted by provincial and local authorities will
need to be reviewed for consistency if national legislation is adopted).

The importation of health care waste is regulated by the Imports and Exports
Act. No legislative provisions exist for ensuring that the environmental
requirements of the Basel Convention for such imports are considered.

The legislation does not indicate how cultural and religious requirements in
respect of health care waste should be approached.

There is an absence of clear and consistent definitions in the legislation.
COMPLIANCE AND ENFORCEMENT
The gaps in the legislative matrix which have been identified above have
consequently resulted in weaknesses in the legislative compliance and enforcement
mechanisms. In this regard, the absence of specific requirements inhibits
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government’s ability to secure compliance with acceptable waste management
practises.
In addition to the above, it is noted that a major generator of health care waste is the
public sector. The Constitutional requirements of co-operative governance mean that
the traditional approaches to enforcement, including prosecution, cannot easily be
resorted to. Apart from the challenges of enforcing legislation in respect of the public
sector, an additional consequence that may eventuate is a reluctance to comply in the
private sector if the standards of enforcement are seen to be uneven and hence
unfairly applied.
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5.
CONSIDERATION OF RECENT INITIATIVES THAT COULD
BE USED AS A BASIS FOR NATIONAL LEGISLATION ON
HEALTH CARE WASTE
In the last few years, the Gauteng Provincial Government, the Western Cape
Provincial Government and Standards South Africa have undertaken initiatives to
address the management of health care waste. Since these initiatives are recent and are
the culmination of intensive pilot projects or research and consultation, the suggestion
was made that these documents be considered as a platform of departure for the
development of national legislation on health care waste. This section of the report
therefore considers these initiatives with a view to assessing whether they could be
used as a basis for national legislation and/ or whether they can inform the approach
which is adopted by the national government.
5.1
GAUTENG
HEALTH
REGULATIONS, 2004
CARE
WASTE
MANAGEMENT
The Gauteng Provincial Government passed a comprehensive set of health care waste
management regulations (“the Gauteng regulations”) in 2004. The regulations are
lengthy and largely reflect a life cycle approach to the management of health care
waste. In addition to establishing a range of authorisation mechanisms for
transporters, transfer facilities and treatment facilities, the regulations contain
minimum requirements for the packaging of health care waste,52 standards for the
disinfection of reusable health care waste containers,53 minimum environmental
performance requirements for controlled combustion54 and non-combustion55
treatment facilities and minimum requirements for transport, storage, collection and
disposal.56
It is trite that those provisions of the regulations which are specific to Gauteng would
have to be refined in order to make them applicable to the country as a whole and
these provisions have therefore not been commented on. The comments below are
accordingly limited to generic comments. (Should DEAT decide that the regulations
could be used as a basis for national regulations, it will be necessary to furnish further
more detailed comments).
5.1.1 General approach
The general approach which has been adopted by the Gauteng Provincial Government
to the regulation of health care waste, namely, establishing specific requirements for
all stages of the life cycle of health care waste, is supported since the regulations
provide a “one-stop” source of understanding what is required of all role-players
52
Schedule 1
Schedule 2
54
Schedule 3
55
Schedule 4
56
Schedule 9
53
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involved in the management of health care waste. The approach of setting out specific
detailed requirements in respect of certain aspects of health care waste management is
also supported since this creates certainty and could reduce the need for the use of
permitting mechanisms which are resource intensive.
5.1.2 The use of permitting mechanisms
Authorisation mechanisms are used to regulate generators, transporters, transfer
facilities and treatment facilities. Several of the authorisation mechanisms also have
mandatory reporting and approval requirements which must be complied with after
authorisation. It is suggested that in developing an approach to national regulations,
consideration should be given to the extent to which such authorisation mechanisms
should be used since the use of these mechanisms is very resource intensive and may
place a substantial additional administrative and financial burden on government.
(This consideration is of particular relevance in instances where provinces will be
responsible for implementing the regulations).
It is submitted that authorisation mechanisms should only be used where a generic set
of rules will not achieve the desired state of management of health care waste and
where effective management will be dependent on the imposition of specific
conditions that are tailored to address each specific operation or activity. Where a
generic set of rules will achieve the same result, the use of imposing standards in
regulations should be preferred since it will relieve pressure on already constrained
resources in government which could be redirected to compliance and enforcement
activities.
In this regard, the need to authorise transporters is questioned since it is assumed that
the nature of the transporting activity will be substantially similar and could be
regulated by means of generic rules or standards. Should the purpose of the
authorisation by underpinned by a need to collect information on the regulated sector
and the nature of waste being transported and disposed of, this could be achieved by
means of a registration system which specifies conditions for registration. The
imposition of a set of criteria for registration could be used to refuse registration to
transport operators who do not have the appropriate qualifications of equipment to
undertake transportation safely.
5.1.3 Reporting mechanisms
The Gauteng regulations require the submission of audit reports in several
circumstances. Whilst the rationale of the requirement is understood, the approach
reflected in the regulations may result in a reduced efficacy of the mechanism. In this
regard, the regulations require that the department accept or reject the audit report. It
is assumed that since the report is supposed to be a factual one, the acceptance or
rejection in practise means an acceptance or rejection of the quality of the report. This
is supported by the fact that the regulations provide that the report may be amended.
The regulations do not, however, indicate what the consequences are in the event that
the report indicates a substantial level of non-compliance, for example, the withdrawal
of permit.
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5.1.4 Planning
The regulations provide that municipalities must establish health care waste
management plans for certain aspects. Given the onus planning obligations on local
government, an approach which combines and streamlines these requirements with
other planning regimes, such as Integrated Development Plans, would be preferred.
5.1.5 Ambit of the regulations
Certain aspects that may be included in the management of health care waste are not
dealt with in the regulations. These include provisions in respect of contractual
arrangements, spillages and clean ups.
It is possible that the inclusion of requirements in respect of permissible emissions
from incinerators may be addressed through the Air Quality Management Act in
which case it would be unnecessary to provide for these matters in health care waste
legislation, except by way of reference to the relevant requirements in the Air Quality
Management Act.
5.1.6 Occupational health and safety matters
In some instances the regulations contain provisions in respect of health and safety
matters. It is questionable whether these provisions are in accordance with the
constitutional imperatives of co-operative governance which are set out in Chapter 3
of the Constitution as they may encroach on the mandate of the Department of
Labour. (These provisions stipulate, inter alia, that all spheres of government and all
organs of state within each sphere must respect the powers and functions of
government in other spheres and not assume any power or function except those
conferred by the Constitution).57
In addition to constitutional considerations, some of the provisions overlap with
requirements that are already contained in the Occupational Health and Safety Act
creating a situation of double regulation. Since the Department of Labour is the organ
of state primarily charged with the regulation of occupational health and safety
matters and the OHS Act applies to workers in the waste sector, it is submitted that it
is not appropriate to include health and safety matters in health care waste regulations,
unless it is by means of referencing the OHS Act.
5.1.7 Approach to drafting
The regulations deviate from drafting practise in that they purport to confer powers on
the MEC in certain instances. This should be reconsidered for two reasons, namely –
57
Section 41(1)(e) and (f)
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

the regulations cannot grant powers which are not expressly provided for in
the Act; and
where powers are provided for in the Act or in terms of common law – such as
the powers to amend schedules - it is redundant to repeat them and may result
in a risk of conflicting interpretation.
Other powers or provisions which are already provided for in the ECA need not be
repeated, for example, the directives to cease operations and power of the courts to
grant interdicts.
In addition to the above, the regulations are very lengthy. To facilitate accessible
reading on the part of the public, the regulations could be streamlined and shortened
by consolidating certain provisions such as the provisions which deal with audit
reports, authorisation conditions, renewal of authorisations and termination of
authorisations.
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5.2
WESTERN CAPE HEALTH CARE WASTE MANAGEMENT BILL
Unlike Gauteng, the Western Cape Provincial Government has elected to regulate
health care waste management by way of own legislation rather than passing
regulations into terms of existing national legislation. In this regard, the Western Cape
Management Draft Bill was published for comment on 9 December 2004.58
The Bill is a combination of express obligations and empowering provisions. With
regards to the direct obligations, the Bill provides a prohibition against the dumping
or mismanagement of health care waste59 and sets out a range of responsibilities for
generators, transporters, treaters and disposers, including a duty of care that all health
care waste is separated at source, packaged, stored, transported, treated and disposed
of in a safe manner that poses no threat to human health or the environment.60 The
general duty of care is amplified by a set out requirements which pertain to storage,
training, the keeping of records and registration. Other requirements rely on the MEC
prescribing standards or further requirements.
5.2.1 General approach
It is submitted that the approach adopted by the Western Cape Government is not one
that would be optimal for national government. The primary reason for this
submission is the fact that the Bill does not contain many substantive provisions in
respect of the cradle-to-grave management of health care waste as it is envisaged that
the MEC will prescribe requirements to address these issues. The Bill may
accordingly be regarded as a “first tier” in a regulatory framework for the
management of health care waste and additional detailed measures will need to be
prescribed to ensure that the regulatory approach to the management of health care
waste is comprehensive.
At the national level, framework enabling legislation for giving effect to health care
waste management already exists and/or will be promulgated in the near future in the
form of the National Waste Management Bill and the Air Quality Management Act.
In view of this, legislation which is developed in respect of health care waste is likely
to be subordinate legislation in terms of one of these acts and that subordinate
legislation will need to set out the detailed approach to health care waste management.
5.2.2 Imposition of responsibilities
Some of the responsibilities of generators, transporters, treaters and disposers are
qualified by wording such as “as far as possible” and “appropriate”. These
qualifications may lead to difficulties in securing compliance with the Bill since the
terms are subjective.
58
PN 255/2004
section 5
60
section 6(1)
59
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5.2.3 Definitions
The definition of health care waste includes general waste. Some of the
responsibilities set out in section 6(2) of the Bill will therefore apply to the generators,
transporters, treaters and disposers of general waste. Present indications are that it is
not intended to include general waste within the national health care waste regulatory
framework.
5.3
THE SANS CODE
The South African National Standards Authority produced code SANS 10248: 2004
(“the code”) on the management of healthcare waste. The code was last updated in
2004. It potentially represents a quick option for the regulation of health care waste at
the national level since the drafting of the regulations incorporating the code into
legislation would in theory be relatively simple and the code can be updated to meet
future needs.
In deciding whether the adoption of the code would be an optimal approach to
regulations, the comments below should be considered.
5.3.1 Accessibility and awareness of the code
The code is written in an accessible format and is generally easy to understand.
However, unlike other legislation, SANS codes are not readily available through
publication in the Government Gazette or on the government websites. The codes
have to be purchased directly from the SANS. This issue is viewed as a serious one
since it has the potential to undermine the principle that, in order to facilitate
compliance with legislative requirements, the requirements should be known and the
legislation should be easily accessible. In this regard, the fact that the codes must be
purchased from the SANS places an additional regulatory burden on, especially, small
businesses and the public. (It is also noted that the document is also copyright
protected and copies thereof cannot be distributed).
Furthermore, during workshops which were conducted by the National Waste
Management Strategy Implementation Project with the provinces regarding health
care management, it emerged that in certain areas there was a very low level of
awareness of the existence of the code.
5.3.2 Incorporation of the codes in legislation
Any regulations which incorporate the code would have to be published for comment.
If there is opposition to portions of the code which are accepted, the process may take
longer than the development of comprehensive regulations since the process for
amending the code is not within the direct control of the department.
In addition to the above, the department does not have direct control over the contents
of the code. This means that changes that are required by the department may be
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cumbersome to mange. Conversely, it is understood that the department does not have
a “veto” right over changes that the SANS wishes to make to the code.
5.3.3 Scope and comprehensiveness of the code
The code itself cannot provide for command-and-control mechanisms such as
permitting. Should the department require registration or permitting procedures,
additional provisions in the regulations will have to be drafted. Furthermore, the code
cannot be used to impose certain other management mechanisms such as obligations
to furnish information.
The definitions contained in the code may present certain difficulties, for example –


the definition of health care waste includes health care waste originating from
households whereas it is understood that the regulations would not necessarily
include such waste; and
the definition of waste may differ from the final definition selected for the
National Waste Management Bill. In this regard, the definition included in the
code does not address the position of by-products which are sold. Although
this may not be of direct relevance to health care waste, it will be problematic
for regulations to incorporate a definition which is not aligned to the parent
Act.
In some instances, the codes provide absolute approaches which may not always be
practical. For example, it provides that waste must be disposed of within 24 or 48
hours. These absolute requirements may therefore require revision.
The code does not provide for emergency situations.
5.3.4 Compatibility with existing legislation
The HBA regulations which were passed in terms of the OHS Act contain detailed
provisions regarding the management of HBA substances. A technical review would
need to be undertaken to assess the extent to which the code is aligned with the
regulations.
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6.
RECOMMENDATIONS
The legislative review set out in the preceding sections indicates that law reform in
respect of the approach to health care waste management is justified. This section sets
out several recommendations or issues that should be considered in developing an
approach to such reform.
6.1
LEGISLATIVE OPTIONS
FRAMEWORK
FOR
CREATING
A
REGULATORY
There are at least six different approaches that could be adopted to the development of
a coherent legislative framework for health care waste management. These options,
together with the advantages and disadvantages are summarised in the table below.
(An assumption which is implicit to all the options is that emission standards will be
passed in terms of the Air Quality Management Act).
Option
Promulgation of a Health Care Waste
Management Act
Inclusion of specific health care waste
provisions in the proposed National Waste
Management Act
Passing Regulations under the proposed
National Waste Management Bill
Passing Regulations under the Environment
Conservation Act
Comment
From informal discussions and insights to the
approaches that are adopted by DEAT to
legislation, it is unlikely that this option
appears will have support. A key difficulty
with the option is that it will add to the
fragmentation of the current waste
management matrix. Continued alignment
with other waste management legislation will
be difficult.
It has been agreed that the proposed National
Waste Management Act should adopt a
framework and enabling approach. This
approach will not accommodate the detailed
regulation that is required to manage health
care waste effectively.
The optimal approach would be to adopt
health care waste regulations in terms of the
proposed National Waste Management Act
since it is intended that the Act establish a
broad waste management framework and the
drafters will be able to ensure that the
regulations are aligned with the approach set
out in the Act. The key disadvantage of this
option is the fact that the proposed National
Waste Management Act may not be
promulgated before 2007. (Alignment with
any regulations under the National Health
Act would have to be considered).
The Act provides for the passing of
regulations on health care waste. A potential
obstacle in passing regulations in terms of
this Act is that it is intended to repeal and
replace the Act in the near future. Although
the regulations can be saved by the proposed
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Option
Passing Regulations under the National
Health Act
Adopting the SANS Code under one of the
Acts above
Comment
National Waste Management Act, the passing
of health care waste regulations prior to the
promulgation of the National Waste
Management Act incurs the risk that the
regulations may not be aligned with the final
approach adopted in the proposed National
Waste Management Act. However, should
regulations be required in the short term, this
option is likely to be the most feasible as it
does not suffer from the challenges presented
by the National Health Act (discussed
below).
The Act provides for the passing of
regulations on health care waste. Officials in
the Department have apparently indicated
support for this option. (The extent of
political acceptance is not known). The key
disadvantage of adopting this option is that it
creates a situation of referee and player for
most health care waste management matters
since the Department which would be
responsible for implementing the regulations
is also responsible for the generation and
management of much of the waste stream. In
addition to this, additional effort will be
required to ensure that the regulations remain
within the framework adopted in the National
Waste Management Act which is the
responsibility of DEAT. A further
consideration is that the approach adopted by
the Department is likely to be focused on the
primary mandate of the Department i.e.
health and environmental issues, which fall
within the expertise of DEAT, may be
overlooked.
The SANS Code in its current form does not
meet all the requirements for a national
health care waste management system,
although Standards South Africa is currently
establishing a process to revise the Code. The
adoption of the SANS code is an attractive
option since it will minimize the time
required to draft regulations. The
disadvantages of the option is that the
regulated community have to pay to have
access to the Code and that the updating of
the Code will not be within the complete
control of the department responsible for
implementing the Code.
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6.2
SCOPE OF FUTURE HEALTH CARE WASTE LEGISLATION
It is recommended that the approach to health care waste legislation be developed on
the basis of the elements set out in the diagramme in section 2. This is not to say that
all the components listed in section 2 must be included in the specific legislative
provision regulating health care waste, but that the approach must ensure that all the
aspects are present in some legislation. The emphasis on the health care waste
legislation should be on developing an approach to all aspects of the life cycle of
health care waste.
6.3
STREAMLINING OF HEALTH CARE WASTE LEGISLATION WITH
EXISTING LEGISLATION
The waste management regulatory matrix is currently fragmented. This situation will
not change because of the Constitutional allocation of functions. Nevertheless, it is
recommended that in developing an approach to health care waste management
legislation, further duplication and/or fragmentation be avoided. In this regard, it is
recommended that efforts be made to utilise existing legislative mechanisms where
possible. Two key areas where this can be achieved are planning requirements and
information management. It is submitted that the existing planning requirements are
adequate for the purposes of health care waste management, although it may be
necessary to develop guidance materials for the authorities to consider in the
development of their plans. It has been agreed that legislative effect will be given to
the waste information system in the proposed National Waste Management Bill.
Information requirements in respect of health care waste should accordingly be
aligned with these provisions.
In addition to the above, it is recommended that air emissions and occupational health
and safety matters be addressed through current legislative mechanisms and that
provisions in this regard are not provided for separately in health care waste
legislation.
6.4
SELECTING LEGISLATIVE MECHANISMS
It is clear that more detailed regulation and control of health care waste management
is required. However, careful consideration should be given to selecting the most
appropriate legislative mechanisms for the management of health care waste. In this
regard, it is suggested that, since authorisation mechanisms such as permitting
requirements are extremely resource intensive, the introduction of such mechanisms
be avoided unless it is necessary to regulate each facility on a case by case basis.
(This consideration is of particular relevance in instances where provinces will be
responsible for implementing the regulations).
Where possible, the use of generic rules or standards should be preferred and the use
of authorisation mechanisms reserved for instances where such rules will not achieve
the desired state of management of health care waste and where effective management
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will be dependent on the imposition of specific conditions that are tailored to address
each specific operation or activity.
6.5
GEOGRAPHICAL AND RESOURCE CONSIDERATIONS
It is noted that the management of health care waste in rural areas is a concern in view
of the access to adequate treatment and disposal facilities that can be managed in an
environmentally sound manner and available resources. Since the management of
health care waste falls within the ambit of the environmental right, a distinction of
required standards which undermines the environmental right and effectively affords a
lesser protection on the basis of geographical location and resource constraints will
not pass constitutional muster. All standards which are adopted will accordingly have
to ensure that equal environmental protection is afforded across the country.
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REFERENCES
1.
Basel Convention on the Control of Transboundary Movement of Hazardous
Wastes and their Disposal, 1989
2.
Constitution (Act No. 108 of 1998)
3.
Department of Environmental Affairs and Tourism, “White Paper on Integrated
Pollution and Waste Management for South Africa - A Policy on Pollution
Prevention, Waste Minimisation, Impact Management and Remediation”, 2000,
Government Gazette Vol.417, No.20978, 17 March 2000. General Notice 227
of 2000
4.
Department of Environmental Affairs and Tourism, “The Situation of Waste
Management and Pollution Control in South Africa” report to the Department
of Environmental Affairs by the CSIR, 1991.
5.
Department of Water Affairs and Forestry, Waste Management Series.
“Minimum requirements for the waste disposal by landfill” 2nd Edition, 1998
6.
Environment Conservation Act, 1989 (Act No. 73 of 1989)
7.
Hazardous Substances Act, 1977 (Act No. 15 of 1977)
8.
Johannessen L, Dijkman M, Bartone, C, Hanrahan D, Boyer M and Chandra C,
Health Care Waste Management Guidance Note, World Bank, May 2000
9.
National Environmental Management Act, 1998 (Act No. 107 of 1998)
10. National Environment Management: Air Quality Act, 2004 (Act No. 39 of 2004)
11. National Health Act, 2003 (Act No. 61 of 2003)
12. National Health and Medical Research Council, “National Guidelines for the
Management of Clinical and Related Wastes” March 1999
13. National Water Act, 1998 (Act No. 106 of 1998)
14. Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)
15. Peckham B, “Some Thoughts on the Regulation of Hazardous Waste Disposal in
South Africa” (1994) 1 SAJELP
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