Legal Analysis: - South African Waste Information...

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

DANIDA

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: Jenny Hall/ NWMSI/HCWReport no: 03 Prepared by: JHVersion no: Final Checked by: KO, TK, TJDate: 2006-04-13 Approved by: PMG

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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...........................................................................................................................63.1.1 Bill of rights.......................................................................................................................63.1.2 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........................................................103.3.1 Principles.........................................................................................................................103.3.2 Planning...........................................................................................................................113.3.3 Environmental management............................................................................................113.3.4 Compliance and enforcement..........................................................................................11

3.4 ENVIRONMENT CONSERVATION ACT, 1989.............................................................................123.4.1 Waste management..........................................................................................................123.4.2 Environmental impact assessments.................................................................................143.4.3 Basel Convention on the Control of Transboundary Movement of Hazardous Wastes and

their Disposal, 1989.......................................................................................................143.5 ATMOSPHERIC POLLUTION PREVENTION ACT, 1965............................................15

3.6 NATIONAL HEALTH ACT, 2003................................................................................................163.6.1 Health services.................................................................................................................163.6.2 Regulations for waste management.................................................................................17

3.7 HAZARDOUS SUBSTANCES ACT, 1977.....................................................................................173.7.1 Regulation of Group IV substances.................................................................................183.7.2 Regulation of disposal.....................................................................................................183.7.3 Application of the Act......................................................................................................19

3.8 OCCUPATIONAL HEALTH AND SAFETY ACT, 1993..................................................................19

4. FINDINGS.......................................................................................................................................21

4.1 INSTITUTIONAL ARRANGEMENTS..............................................................................................214.2 PLANNING.................................................................................................................................224.3 COLLECTION AND DISSEMINATION OF INFORMATION...............................................................234.4 DEFINITIONS AND CLASSIFICATION..........................................................................................234.5 REGULATION OF HEALTH CARE WASTE THROUGHOUT THE LIFE CYCLE...................................244.6 COMPLIANCE AND ENFORCEMENT............................................................................................26

5. 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....................................285.1.1 General approach............................................................................................................285.1.2 The use of permitting mechanisms...................................................................................295.1.3 Reporting mechanisms.....................................................................................................295.1.4 Planning...........................................................................................................................305.1.5 Ambit of the regulations...................................................................................................305.1.6 Occupational health and safety matters..........................................................................305.1.7 Approach to drafting........................................................................................................30

5.2 WESTERN CAPE HEALTH CARE WASTE MANAGEMENT BILL.....................................................325.2.1 General approach............................................................................................................325.2.2 Imposition of responsibilities...........................................................................................325.2.3 Definitions........................................................................................................................33

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5.3 THE SANS CODE...................................................................................................................335.3.1 Accessibility and awareness of the code..........................................................................335.3.2 Incorporation of the codes in legislation.........................................................................335.3.3 Scope and comprehensiveness of the code......................................................................345.3.4 Compatibility with existing legislation............................................................................34

6. RECOMMENDATIONS...............................................................................................................35

6.1 LEGISLATIVE OPTIONS FOR CREATING A REGULATORY FRAMEWORK......................................356.2 SCOPE OF FUTURE HEALTH CARE WASTE LEGISLATION............................................................376.3 STREAMLINING OF HEALTH CARE WASTE LEGISLATION WITH EXISTING

LEGISLATION.....................................................................................................................376.4 SELECTING LEGISLATIVE MECHANISMS....................................................................................376.5 GEOGRAPHICAL AND RESOURCE CONSIDERATIONS..................................................................38

References................................................................................................................................................39

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National Waste Management Strategy Implementation Project

LIST OF ABBREVIATIONS

DEAT: Department of Environmental Affairs and TourismDWAF: Department of Water Affairs and ForestryDOH: National Department of HealthECA: Environment Conservation Act, 1989EIA: Environmental Impact AssessmentHBA Regulations: Hazardous Biological Agents Regulations, 2001HCW: Health Care WasteIP & WM: Integrated Pollution and Waste ManagementNEMA: National Environmental Management Act, 1998OHS Act: Occupational Health and Safety Act, 1993

Legal Review - Health Care Waste Management Legislation (13 April 2006) (JH) iv


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.

Legal Review - Health Care Waste Management Legislation (13 April 2006) (JH) 1


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 20003 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,



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 co-operation 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 March 19996 This approach is also implied by the World Bank Guidance Note, op cit.




Definitions

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.

Institutional arrangements

Mechanisms for planning

Collection & dissemination of

information

GO

VERN

MEN

T M

ANAG

EMEN

T M

ECH

ANIS

MS

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.

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.

Regulation of the life cycle of HCW

including –generation

StorageCollection and transportation

Treatmentdisposal

Compliance and enforcement

CON

TRO

L M

ECH

ANIS

MS

PRO

CED

URA

L M

ECH

ANIS

MS

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.


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

7 Department of Environmental Affairs and Tourism, “The Situation of Waste Management and Pollution Control in South Africa” report by the CSIR, 19918 Act No. 108 of 19969 Act No. 107 of 199810 Act No. 106 of 199811 Peckham B, “Some Thoughts on the Regulation of Hazardous Waste Disposal in South Africa” (1994) 1 SAJELP, page 95



way which ensures that the management health care waste is implemented in a co-ordinated 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) to an environment that is not harmful to their health or well-being; and(b) 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 214, it is clear that all organs of state are bound by the right and must give effect to it. 12 Act No. 108 of 199613 Section 2414 For example, sections 7 and 8



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 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 15 Promotion of Administrative Justice Act and the Access to Information Act.16 Act No. 2 of 200017 Act No. 3 of 2000



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 by-laws 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 Schedule 5Part A Environm

ent Health

services Pollution

control

Part A Abattoirs Veterinary services,

excluding regulation of the profession

Part B Air pollution

Municipal health services

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, “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).

3.2 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



3.3 NATIONAL ENVIRONMENTAL MANAGEMENT ACT, 199819

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 “sub-principles.” 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 Act No. 107 of 199820 May 2000



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 co-ordination 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 Section 1222 Act No. 39 of 2004



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, except-

a) at a disposal site for which a permit has been issued in terms of subsection (1);

23 Act No. 73 of 198924 GNR 1986, GG 12703, 24 August 1990



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)26 Section 20(1)27 Regulations that have been passed include those for waste disposal site permit applications (GNR 11196, GG 15832, 8 July 1994).



3.4.2 Environmental impact assessments

Until the NEMA EIA regulations are passed, the ECA requirements28 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. The Convention has three interdependent goals namely -

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 –

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;

28 Sections 21 and 22 and GNR 1182 & 1183, September 199729 Act No. 45 of 1965



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.

3.5 ATMOSPHERIC POLLUTION PREVENTION ACT, 196530

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 -

“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.

30 Act No. 45 of 196531 Process no. 39



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 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.32 Section 933 See for example the comments made in the technical documents produced as part of the National Waste Management Strategy Implementation Project34 Act No. 61 of 200335 Section 136 Section 90(1)(n)37 Section 32(1)



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)39 Section 21(2)(b)(ii)40 GG 6715, GNR 21, 200041 Act No. 15 of 1977



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) has an activity concentration of more than 100 becquerels per gram and a total activity of more than 4 000 becquerels; or

(b) 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 Regulation 246 of 26 February 199343 GN Regulation 247 of 16 February 1993



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).

3.8 OCCUPATIONAL HEALTH AND SAFETY ACT, 199344

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 199345 Act No. 16 of 200246 Section 24



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 200148 Regulation 249 Regulation 17



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

Relevant mandate Legislation Comments

Minister of Health & Department of Health

Public health and health services

National Health Act;Hazardous Substances Act

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.

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

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.

Minister of Labour&Department of Labour

Protection of worker health and safety

Occupational Health and Safety Act including the HBA Regulations

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



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

Regulation of animal health

Excluded from the ambit of this report

Provincial departments

Concurrent responsibility for the protection of the environment

Some provincial departments have passed regulations in respect of HCW

Provincial legislation will need to be aligned with any national legislation that is promulgated

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

By-laws not reviewed as part of this project. It is noted however, that several municipalities have by-laws which include provisions regarding the management of HCW

By-laws will need to be aligned with any national legislation that is promulgated

4.2 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

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 50 Section 33



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 have their own systems - such as the Hazardous Substances Act which provides for the grouping of substances into one of four categories.

51 Regulation 9



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 Storage Transportation

Disposal

Atmospheric Pollution Prevention Act

Provisional and/ or final registration certificate required

May be addressed in registration certificate

X X

Environment Conservation Act – Waste

provisions; EIA

requirements; Basel

Convention

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

Not expressly, but sometimes dealt with through permitting requirements

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)

Permits required to operate waste disposal facilities;waste may only be disposed of in permitted facilitiesEIA authorization required for the establishment of disposal facilities

Hazardous Substances Act

Licenses required for Group IV substances - waste regulated through permit conditions and regulation

Storage of Group IV substances regulated by regulations – may not apply to HC waste

Importation or exportation of Group IV substances requires permission;Provisions of the Act apply to substances in transit on request of

Group IV waste regulated through license conditions and regulation



Act Generation Storage Transportation

Disposal

another country;

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

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

National Health Act

Regulatory power – no specific provisions




Occupational Health and Safety Act

X Duty to ensure that waste is properly stored and controlled to prevent the spread of infection

Drivers to be trained and waste to be labelled

Work procedures to be introduced;Reference is made to the requirements of the Environment Conservation Act and Atmospheric Pollution Prevention Act

National Road Traffic Act

Comprehensive provisions including the need for drivers to be trained and waste to be labelled

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 –

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.

4.6 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 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.



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 CARE WASTE MANAGEMENT REGULATIONS, 2004

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 involved in the management of health care waste. The approach of setting out specific 52 Schedule 153 Schedule 254 Schedule 355 Schedule 456 Schedule 9



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.



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 –

the regulations cannot grant powers which are not expressly provided for in the Act; and

57 Section 41(1)(e) and (f)



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.



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 255/200459 section 560 section 6(1)



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



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.



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 FOR CREATING A REGULATORY FRAMEWORK

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 CommentPromulgation of a Health Care Waste Management Act

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.

Inclusion of specific health care waste provisions in the proposed National Waste Management Act

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.

Passing Regulations under the proposed National Waste Management Bill

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).

Passing Regulations under the Environment Conservation Act

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



Option CommentNational 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).

Passing Regulations under the National Health Act

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.

Adopting the SANS Code under one of the Acts above

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.



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



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.



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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