Ian Sampson, Partner:Environmental

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THE LEGAL REQUIREMENTS FOR THE TREATMENT AND
DISPOSAL OF MEDICAL WASTE IN SOUTH AFRICA
Ian Sampson
Partner, Environmental & Sustainability Law,
Shepstone & Wylie Attorneys
Tel: (031) 566-8260 ; Fax: (031) 566-2097 ; Cell: 082 775 3720
ABOUT THE SPEAKER
Ian is an environmental lawyer. He is a member of the environmental committee of the Institute of Directors
of Southern Africa, the chairman of the environmental committee of the American Chamber of Commerce in
South Africa and the co-chairman of the environmental committee of the Durban Chamber of Commerce. He
has written or edited several books, including the Guide to Environmental Auditing in South Africa
(Butterworths, December 2000) and a Legal Framework to Pollution Management in South Africa (Water
Search Commission, 2001).
He acts for both private and public sector clients on a range of environmental regulatory issues.
ABSTRACT
From no regulation to over regulation? From fragmented regulation to a co-ordinated, holistic approach?
From confusion to clarity? Until the recent waste management developments at a national and regional
level, an apparent vacuum in appropriate healthcare waste management laws existed in South Africa.
Based on an erroneous interpretation of the Human Tissues Act, the Department of Water Affairs & Forestry
has required, until recently that all-healthcare waste be incinerated. This resulted in certain instances of
efficient healthcare waste incineration by certain operators, but largely inefficient incineration by the vast
majority of healthcare waste generators often through poorly maintained and inappropriate burners at
healthcare facilities. However with the development of the National Waste Management Strategy, the
National Waste Management Bill (still to be officially published for comment) and regional initiatives such as
the Gauteng Healthcare Waste Strategy and the Draft to KwaZulu-Natal Waste Policy, an improved, more
effective regulatory framework is emerging.
The paper will look at the historical healthcare waste management laws, and discuss the environmental and
liability implications they create and the liability legacy they will leave. It will then consider the emerging
regulatory framework and describe the new or emerging standards healthcare waste generators, handlers,
transporters and disposes need to comply with. It will discuss the fact that although a single national waste
management law is being developed, there are a range of other laws at a national, provincial and local level
which those involved with healthcare waste need to consider.
THE LEGAL REQUIREMENTS FOR THE TREATMENT AND DISPOSAL OF MEDICAL
WASTE IN SOUTH AFRICA
1
INTRODUCTION
There is currently no clear legal directive on how medical waste must be treated and disposed of. Pending or
proposed laws and standards do not, at this stage, appear to be going to satisfactorily address this lack of
clarity.
2
CURRENT LAW
2.1
An apparent misunderstanding
There appears to have been a consistent, and thus far inexplicable, misinterpretation of the Human Tissue
Act 65 of 1983. This error appears to have been consistently applied over time and is to be found in the
current waste management documents produced by national government, and which form the basis of
proposed future regulatory requirements with respect to medical waste treatment and disposal. As such we
have considered the misunderstanding from the oldest source to the most recent:
(a)
The Minimum Requirements for the Handling, Classification and Disposal of Hazardous Waste
(Department of Water Affairs and Forestry, 2nd edition, 1998) Guideline document
Paragraph 9.4.1 stipulates that “medical waste must be incinerated, since the Human Tissue Act
requires that all human parts be incinerated”.
(b)
The National Waste Management Strategy (Version D, 15 October 1999)
Paragraph 11.1.5 “medical waste generators will be required to … sort their waste to ensure that
only the infectious waste, which must be incinerated, (as required by the Human Tissue Act) is
collected and subsequently treated”.
(c)
Action plan for Waste Treatment and Disposal (Version C, 15 September 1999, Part of the National
Waste Management Strategy Series)
Paragraph 1.1.1 “The majority of operating incinerators in South Africa are used for treatment of
infectious medical waste, as stipulated in the Human Tissue Act”.
Paragraph 1.3 listed as a priority initiative for the development of guidelines for the safe
management of medical waste by 2001, will include guidelines for the separation of waste at source
into infectious waste which requires incineration (according to the Human Tissue Act) and non
hazardous medical waste that can be disposed of by alternate methods.
Furthermore, and although not specifically referring to the alleged requirements of the Human Tissue Act, the
White Paper on Integrated Pollution and Waste Management for South Africa (GNR227, GG20978 of 17
March 2000) and the Proposed Regulations for the Control of Environmental Conditions Constituting a
Danger to Health or a Nuisance in terms of the Health Act 63 of 1977 (GNR21, GG20796 of 14 January
2000) appear to perpetuate the misunderstanding by highlighting proposed medical waste treatment
procedures as being founded upon a need to incinerate.
From a careful reading of the Human Tissue Act 65 of 1983 and regulations promulgated in terms thereof, no
stipulation cab be found that “medical waste” must be incinerated. In fact the Act does not make use of the
term “medical waste”, but rather describes what have traditionally been considered to be its constituents,
namely blood and tissue. The Act limits the definition of “blood” to human blood (Section 1), and defines
“tissue” as:
“(a)
(b)
any human tissue, including any flesh, bone, organ, gland or body fluid, but excluding any blood or
gamete; and
any device or object implanted before the death of any person by a medical practitioner or dentist in
the body of such person”.
(Section 1)
The following provisions from the Act appear, to be the only provisions that deal with what is now commonly
known as medical waste:
(a)
(b)
(c)
(d)
(e)
An inspector of anatomy may remove and bury the remains of human body or tissue from any
premises inspected if he deems it advisable (Section 31(1)(g)).
The Minister of Health has authority to make regulations regarding the disposal, otherwise than in
terms of Section 31(1)(g), of human bodies and tissue no longer required for any purposes referred
to in Section 4(1) (Section 37(1)(a)).
The Minister may further make regulations regarding the conditions for the disposal, otherwise than
in accordance with Section 31(1)(g) of tissue or gametes no longer required for any of the purposes
referred to in Sections 4(1) or 19, as the case may be (Section 37(1)(c)(iii)).
The Minister may make regulations regarding the regulation and control of the disposal of human
bodies handed over to institutions in terms of Section 12(1) and may furthermore make regulations
with respect to the disposal of blood withdrawn or imported blood (Section 37(1)(e)(ii) and (iv)).
Finally where tissue, blood, blood product or gametes has in the opinion of the Director-General
been imported contrary to the provisions of Section 25 of the Act or the conditions of a permit issued
under that Section, the Director-General may order the importer concerned to destroy the blood,
alternatively that the blood be forfeited to the State, and the Director-General can then dispose of it
in such a manner as she or he deems fit (Section 26(1) and (2)).
Consequently the Act itself gives no clear directive to incinerate any medical waste, infectious or otherwise.
At best there is an indication that blood must be destroyed, although no stipulation is given with respect to
the technology which must be used. Arguably this in fact constitutes the exception rather than the rule to the
Act, given the context of Section 31(1)(g)) which requires that the inspector is to remove and bury the
remains of a human body or tissue.
With respect to the powers the Minister has been given to create regulations regarding the disposal of
human bodies or tissue, the only regulation of any relevance that we were able to find were the general
regulations, namely the Regulations in terms of the Human Tissue Act (GNR2876, GG12234 of 29
December 1989). Regulation 2 is headed “Disposal of bodies and tissue” and stipulates:
“Subject to the provisions of Section 31(1)(g) of the Act and any other law relating to the disposal of a human
body or tissue, an institution which or a person who has, in terms of any provision of the Act, obtained a
human body or tissue, and no longer requires such body or tissue or any part thereof for any of the purposes
referred to in Section 4(1) of the Act shall–
(a)
bury or cause to be buried such body or tissue or such part thereof; and
(b)
enter in the register referred to in Regulation 3, the date, place and manner of such burial”.
The regulation therefore stipulates burial of tissue, and does not require incineration.
It is at this stage therefore not clear where or how the misunderstanding of the Act originated, and why it has
seemingly been perpetuated in subsequent waste guidelines, national policy and proposed regulations.
2.2
Medical waste and current waste management laws
In light of the fact that there is seemingly no specific and direct legal requirement that medical waste be
incinerated, it needs to be considered whether incineration must be performed in terms of any other waste
management law currently having application in this country.
The principle definition of “waste” and the one having relevance in the context of this opinion, is contained in
the Environment Conservation Act 73 of 1989 and specific waste regulations promulgated in terms thereof
(see Section 1 of the Act and GN1986, GG12703 of 24 August 1990). Medical waste does, in our opinion,
fall within the ambit of this definition.
“Disposal site” also has relevance, and is once again defined in the Environment Conservation Act as “a site
used for the accumulation of waste for the purposes of disposing or treatment of such waste” (Section 1).
Medical waste would fall within this definition given that it is being disposed of whether through treatment or
otherwise.
These definitions are of relevance given that the Environment Conservation Act stipulates that all waste is to
be disposed of at a disposal site for which a permit has been issued or in terms of a manner or by means of
a facility or method and subject to such conditions as the Minister of Environmental Affairs and Tourism may
have prescribed in regulations (Section 20(6)). No regulations have been prescribed by the Minister with
respect to the disposal of medical waste to date.
However the form of technology to be used for medical waste disposal is probably indirectly influenced
through the fact that medical waste must be disposed of at a site for which a permit has been issued by the
Minister of Water Affairs and Forestry. This permit is issued in terms of Section 20(1) of the Environment
Conservation Act and allows the Minister to issue a permit subject to such conditions as he or she may deem
fit (Section 20(1)(a)). The principal grounds used by the Minister for issuing permits and imposing conditions
are set out in the three guideline documents published by the Department, the most recent edition having
been published in 1998. Of relevance to this opinion is the guideline document dealing with the Minimum
Requirements for the Handling, Classification and Disposal of Hazardous Waste. As indicated these
guidelines specifically, although incorrectly in our opinion, stipulate that medical waste must be incinerated
as a requirement of the Human Tissue Act. Despite this error, the fact remains that the Minister will not issue
a permit to a site to landfill medical waste unless and until it has either been sterilised or incinerated
(paragraph 9.4.1, page 9-5). Although not considered in detail for this opinion, it should be borne in mind that
this may expose the Department to legal challenge on the basis that its refusal to allow medical waste
landfilling is based on an erroneous interpretation of the Human Tissue Act.
If no landfill is permitted to take anything but incinerated medical waste ash or sterilised medical waste, then
the Department of Water Affairs and Forestry is indirectly stipulating which technology may be used for the
disposal of medical waste given that it will be necessary to landfill the waste in whatever form at a certain
stage in the treatment process.
The Atmospheric Pollution Prevention Act 45 of 1965 may also indirectly influence the use of incineration.
Once again no clear reference is made to medical waste incineration although item 39 to the Second
Schedule to the Act lists waste incineration processes as being Scheduled processes requiring a certificate.
Guidelines for medical waste incineration have been drawn up.
This position must also now be tested against the principles set out in Section 2 of the National
Environmental Management Act 107 of 1998. This is in light of the fact that these principles apply to the
actions of all organs of state and:
(a)
(b)
serve as guidelines by reference to which any organ of state must exercise any function when taking
any decision in terms of any statutory provision concerning the protection of the environment; and
guide the interpretation, administration and implementation of any law concerned with the protection
or management of the environment (Section 2(1)(c) and (e)).
Although none of the approximately twenty principles directly discusses the acceptable form of treatment and
disposal for medical waste, several of the principles will influence the validity of the current stance taken by
the Department of Water Affairs and Forestry with respect to the issuing of disposal permits, (and thereby its
influence over medical waste disposal), and any future laws or standards emanating from any other
government department which endeavour to regulate this subject.
The following are some of the more relevant principles which may have a direct influence:
(a)
Included in the consideration of whether sustainable development is being applied, authorities must
ascertain whether waste is being disposed of in a responsible manner (Section 2(4)(a)(iv)). As such
it will need to be determined what constitutes responsible disposal with respect to medical waste.
Some indication is highlighted in the principles which follow.
(b)
Government agencies must endeavor to ensure that pollution and degradation of the environment
are avoided, or where it cannot be altogether avoided are minimised and remedied, and further
negative impacts on the environment and on people’s environmental rights must be anticipated and
prevented or at the very least minimised and remedied (Section 2(4)(a)(i) and (viii)). As such medical
waste treatment technology must be such that it must have no impact on human health or the
environment or, if this is not realistic, must have the least impact possible, with the latter position
only being acceptable if any harm which is caused is remedied. Given the current concerns with
respect to the emissions from incineration, this principle may play a significant role in the selection of
the most appropriate treatment technology.
(c)
Supporting the above principle is the principle that a risk averse or cautious approach is applied,
which takes into the limits of current knowledge about the consequences of decisions and actions
(Section 2(4)(a)(vii)). This principle, also known as the precautionary principle, suggests that where
the environmental impact of a proposed project is not fully understood due to the lack of information
or limits of current science or technology, decision takers should err on the side of caution and
refuse to allow the waste treatment methods. This would clearly have a direct bearing on any
alternate medical waste treatment methods, where the precise impacts on the environment of the
technology are not fully known or understood.
(d)
All of the aforementioned principles must also be measured against the overarching environmental
management standard set out as a principle in the National Environmental Management Act, namely
the Best Practicable Environmental Option standard (Section 2(4)(b)). The Act defines the standard
as “the option that provides the most benefit or causes the least damage to the environment as a
whole, at a cost acceptable to society in the long term as well as in the short term (Section 1(1)).
Although this principle requires additional interpretation, the simple meaning of the term indicates
that in the event that incineration, micro-waving or any other proposed medical waste treatment does
not amount to the Best Practicable Environmental Option, it should not be allowed.
(e)
There are several social justice principles which will also need to be taken into account. These have
relevance insofar as no new medical waste treatment plant should be allowed unless the interested
and affected public have had an opportunity to voice their concerns. These principles include the
environmental justice principle whereby adverse environmental impacts must not be distributed in
such a manner as to unfairly discriminate to any person, particularly vulnerable and disadvantaged
persons (Section 2(4)(c)). Moreover the principles require that decisions must take into account the
interests, needs and values of all interested and affected parties and that the social, economic and
environmental impacts of activities, including disadvantages and benefits, must be considered,
assessed and evaluated, and the decisions taken must be appropriate in light of the conclusions
reached (Sections 2(4)(h) and (i)). Very importantly the principles stipulate that decisions must be
taken in an open and transparent manner (Section 2(4)(k)).
In summary therefore any decision with respect to the appropriate form of medical waste treatment must, at
the very least, take all of the above into account. There is however, in our opinion, currently no clear legal
directive on the appropriate method for disposal of medical waste.
3
FUTURE DIRECTIONS
As indicated in the Introduction and as will be highlighted below, the current policy and strategy documents
do not give any specific indication on the acceptable form of treatment, save to apparently continue the
misunderstanding surrounding the Human Tissue Act.
Besides the principles contained in the National Environmental Management Act 107 of 1998 having
overarching environmental management relevance, the following will play a role with respect to medical
waste disposal:

The White Paper on Integrated Pollution and Waste Management for South Africa (GNR227, GG20978
of 17 March 2000)

The National Waste Management Strategy (Version D, 5 October 1999)

The proposed National Waste Management Act, and its regulations.

The proposed regulations in terms of the National Waste Management Strategy.

The Proposed Regulations for the Control of Environmental Conditions constituting a Danger to Health
or a Nuisance in terms of the Health Act 63 of 1977 (GNR21, GG20796 of 14 January 2000).
3.1
The White Paper on Integrated Pollution and Waste Management for South Africa
The White Paper recognises that waste disposal sites containing medical waste may result in land pollution
problems (paragraph 3.3). As such the White Paper highlights as one of its strategic goals, in dealing with
the effective institutional framework and legislation, to develop and implement regulations and guidelines for
the safe management of medical waste in partnership with the Department of Health (paragraph 5.2.1). As
such it would appear that medical waste regulations will be developed through the partnership between the
Department of Environmental Affairs and Tourism and the Department of Health. This makes the proposed
regulations in terms of the Health Act discussed below (at 3.3) particularly important given that an entire
chapter has been dedicated to medical waste.
A second strategic goal, regarding pollution prevention, waste minimisation, impact management and
remediation has as some of its short term deliverables the following:
(a)
(b)
(c)
To develop a classification system for medical waste facilities, including incineration and alternative
treatment technologies.
To complete a plan for a system of medical waste treatment plants, and thereafter establish
additional medical waste treatment facilities to be operated in accordance with this plan.
To develop a revised air emissions standard for waste incineration facilities that will consider
international standards and South African conditions, and be graded according to the size of the
facilities and the type of waste incinerated.
(paragraph 5.2.2)
Points (a) and (b) above have direct relevance to medical waste and importantly indicate that government
intends allowing such waste to be treated both by way of incineration and through alternative treatment
technologies. As such, and contrary to what has been suggested in some quarters, it would not appear that
incineration of medical waste is to be legally discontinued. Whether, as will be discussed under the National
Waste Management Strategy below, the support for incineration remains due to misunderstanding of the
Human Tissue Act, or whether national government has determined that it constitutes the Best Practicable
Environmental Option for medical waste, remains to be determined.
Encouragingly what also comes out of the White Paper, and as set out in point (b) above, is that national
government will support the establishment and operation of additional medical waste treatment facilities.
Although the White Paper is not law per se, it may arguably be used to compel government to comply with its
own policy should it at any stage refuse to assist, on unreasonable grounds, with the Compass proposal to
establish a further medical waste treatment facility.
Point (c) above is of relevance as although not directly referring to medical waste, it is likely that one of the
revised air emission standards for incineration will include medical waste treatment facilities. Importantly, in
conducting this review of standards, national government intends taking into account international standards
as well as South African conditions.
3.2
The National Waste Management Strategy
The National Waste Management Strategy provides practical guidelines and steps towards giving effect to
the White Paper on Integrated Pollution and Waste Management. With respect to medical waste the
following is of relevance:
(a)
National government was supposed to develop guidelines and strategies before the end of 2000 to
assist provincial governments to plan for management of medical waste (paragraph 7.1.5). These
guidelines were to stipulate that medical waste must be sorted into general and hazardous waste,
and that hazardous waste must be further separated into biological and chemical wastes, infectious
wastes, and materials that have come into contact with infectious matter. The deadline for
implementation of the guidelines for medical waste was 2001. Provincial plans were to be submitted
by 2003 for urban areas and 2007 for rural areas (paragraph 7.1.5). None of this, to the best of our
knowledge has occurred to date.
(b)
Recycling of medical waste is not seen to be viable due to the potential health risks. Recycling will
only be viewed as a longer term objective (paragraph 10.1.5).
(c)
With respect to collection and transportation of medical waste, sorting is required (paragraph 7.1.5).
“Medical waste generators will be required to … sort their waste to ensure that only infectious waste,
which must be incinerated (as required by the Human Tissue Act) is collected and subsequently
treated” (paragraph 11.1.5).
The issues which arise form the aforementioned statement are as follows:
(d)
(i)
The statement indicates that only infectious waste may be incinerated. No clear description
of what “infectious waste” will entail is given.
(ii)
As highlighted separately in this paper, the reference to the Human Tissue Act is, in our
opinion, wrong.
(iii)
Paragraph 11.1.5 goes on to add that “it will be the responsibility of the medical waste
generator to ensure safe destruction and / or disposal of their waste. As such the onus is
placed on the hospitals, clinics, doctors etc to ensure that their medical waste is safely
destroyed and disposed of. This is in line with the cradle-to-grave principle applying to all
waste streams.
With respect to treatment the National Waste Management Strategy envisages that it will reduce the
amount of medical waste that requires treatment. It adds that as a priority medical waste incinerators
currently in operation must be upgraded to comply with revised standards or decommissioned and
replaced by new facilities (paragraph 12.1.5). Although raised as a priority issue, it must be
remembered that to date no revised medical waste treatment standards have been established. This
once again reinforces government’s intention to maintain incineration as the principal form of medical
waste treatment.
Should co-ordinated planning between the provinces find that large regionally based facilities are
more economically viable than a large number of small operating plants, the establishment of large
regionally based facilities will be promoted (paragraph 12.1).
The strategy envisages that facilities that comply with the revised standards were to have been in
operation by 2002, and the collection and the treatment system will be implemented in the rural
areas by 2008.
The time schedule given for the closure of medical waste incinerators not meeting new air emission
standards, and for the planning and establishment of modern facilities in urban areas was to have
been initiated during 2000, and completed, as stated above, by 2002.
(e)
Finally, with respect to disposal, the National Waste Management Strategy envisages medical waste
requiring treatment followed by disposal of ash or other residues at a permitted waste disposal site.
“Disposal of unsterilised infectious medical waste to landfill will not be allowed” (paragraph 13.1.5).
Importantly this statement once again indicates that incineration will seemingly be the preferred
technology, although sterilisation and other treatment methods will be allowed.
(f)
One of the documents forming part of the National Waste Management Strategy is the Action Plan
for Waste Treatment and Disposal. This document in essence repeats what has been summarised
above under the National Waste Management Strategy but does make certain additional comments
which may have relevance:



It suggests that medical waste incineration was included in the Atmospheric Pollution
Prevention Act 45 of 1965 for the first time in 1993 / 1994. Although an air emission standard
and incineration procedure for medical waste was prepared, these are merely guidelines and do
not form part of the Atmospheric Pollution Prevention Act unless incorporated as conditions in a
scheduled process certificate issued by the Department of Environmental Affairs and Tourism.
From a consideration of this Act, we can find no specific reference to medical waste
incineration. Item 39 of the Schedule to the Act listing the processes requiring a certificate refers
to “waste incineration processes”, although once again no specific reference is given to medical
waste.
Despite the above, the document adds that as none of the medical waste incineration guidelines
could be met by any of the incinerators in South Africa, government took the following decisions:
By December 2001 all existing incinerators were to have been upgraded or replaced to meet the
required two stage incineration temperatures and resident time.


New incinerators, with a capacity of less than 1 000 kgs an hour, must operate at the required
temperatures and resident time. If the emissions standards cannot be met, an acceptable
dispersion model may be used to determine whether the incinerator is acceptably located.
All incinerators with a capacity of more than 1 000 kgs an hour must be fitted with pollution
control equipment.
(paragraph 1.2.3)

This document also gives more direction with respect to revised air emission standards, and
indicates that these were to have been finalised by the Department of Environmental Affairs and
Tourism by December 2001 (paragraph 3.4).

As has been referred to above, the Department of Environmental Affairs and Tourism in
collaboration with the Department of Health will produce medical waste treatment guidelines. In
taking into account international standards, this document suggests, by way of example, making
use of the SABS Code of Practice 0248 which is based on the Canadian guidelines, as a
starting point for the development of an improved system of separation of infectious waste from
non-infectious waste (paragraph 3.5). The proposed guidelines will apparently look to removing
non-hazardous waste from the incineration process to reduce incinerator emissions and costs
for medical institutions. The guidelines will also introduce standardisation of medical waste
containers and labelling. Very importantly for this project, the guidelines will consider alternative
technologies for medical waste treatment, and specifically refers to microwaving, autoclaving or
other appropriate technologies. The guidelines will be provided on their acceptability and
feasibility for replacing or supplementing incineration technology that is still common in South
Africa (paragraph 3.5.1).
Finally, the guidelines aim to reduce air emission problems by giving consideration to restricting
the use of halogenated plastics, particularly polyvinyl chloride, in medical equipment and waste
containers that are incinerated (paragraph 3.5.1).
3.3
Proposed Regulations for the Control of Environmental Conditions Constituting a Danger to Health
or a Nuisance in terms of the Health Act 63 of 1977
These draft regulations were first published on 14 January 2000. To date no further indication has been
given as to whether they will be passed and implemented.
The proposed regulations contain a separate chapter on the Handling and Disposal of Medical Waste
(Chapter 6).
A proposed definition for “medical waste” is given. The definition is long, and as such will not be repeated
here. However it envisages five classes of medical waste namely:





Class A – Anatomical waste
This includes human and animal anatomical waste.
Class B – Infectious non-anatomical waste.
Class C – Sharps and similar waste.
This lists any clinical item capable of causing a cut or puncture.
Class D – Pharmaceutical and genotoxic chemical waste.
Class E – Radioactive waste.
Which must be disposed of in accordance with the Nuclear Energy Act 131 of 1993.
(Regulation 1(1))
In light of the definition of “anatomical waste” referring to “biomedical material” it is also useful to consider the
proposed definition for this latter term:
“(a)
(b)
(c)
Human and animal anatomical material, such as tissue, organs, body parts, products of conception
and animal carcasses;
Non-anatomical human and animal material, which is deemed to be blood, body fluids, extracted
teeth, nail clippings and hair;
Medical equipment such as blood bags, intravenous fluid containers or tubes, colostomy or catheter
bags, bandaging, blood collection tubes, medication viles and ampoules, microscopic slides and
(d)
other laboratory glass, injection syringes and needles, surgical blades and any other clinical items
capable of causing a cut or puncture or injections;
human or animal vaccines, pharmaceutical products such as drugs and medicines, and chemical
compounds that are genotoxic”.
(Regulation 1(1))
Given the chapter heading referring to “Disposal of Medical Waste”, it would be reasonable to expect the
chapter to describe the method for disposal of such wastes. Regulation 18 is headed “Duties of Generators,
Transporters and Disposers of Medical Waste”. It suggests, although not very clearly, three apparent
disposal methods:



Disposal is to take place in accordance with this chapter, subject to the provisions of the Environment
Conservation Act 73 of 1989 and any other applicable legislation (Regulation 18(1)).
The activity of disposing is to be carried out in such a way that medical waste generated does not cause
a nuisance or a health or safety hazard for any handler of the waste or any other person or the
environment in general (Regulation 18(2)). (Note that a specific definition for “nuisance” is proposed
although no definition of “a health or safety hazard” is given. Presumably the latter term would be
determined from other appropriate legislation.)
A local authority may with provincial consent (presumably from the appropriate provincial health
department and environmental department), allow a person to dispose of medical waste in any other
acceptable manner provided the medical waste method of disposal does not constitute a nuisance or a
health or safety hazard for any handler thereof or any other person or the environment in general
(Regulation 18(3)).
What is clear therefore is that although a specific form of treatment is not prescribed, the regulations will
allow for disposal of medical waste by way of any technology or treatment method provided it does not cause
a nuisance or a health or safety hazard to humans or to the environment in general. Furthermore a local
authority can, with the permission of provincial government, allow an alternate medical waste disposal
method.
The only other indication of the method to be used is prescribed in proposed Regulation 19(5) which
indicates that an incinerator or incineration process must comply with the prescriptions of the local authority
and all relevant legislation, some of which it lists, in order to deal with waste having a wide variation of
burning characteristics, ranging from highly volatile and high calorific value plastics to high water content
material such as placentae. Therefore although not stipulating that incineration must be used, the proposed
Regulations clearly envisage incineration of medical waste continuing.
4
CONCLUSION
Although the current requirement of various regulatory authorities that medical waste must be incinerated is,
based on a misunderstanding of the Human Tissues Act, this method can probably be enforced through the
waste disposal permit procedure issued by the Department of Water Affairs and Forestry. Whether it is the
Best Practicable Environmental Option or not is an issue which remains outstanding and needs to be tested
against the environmental principles set out in Section 2 of the National Environmental Management Act 107
of 1998. What is clear is that the future waste management laws, which are in the process of being
formulated and given effect, clearly still envisage incineration as a viable form of medical waste treatment
and disposal. Moreover the future direction indicates that other forms of treatment technology will be allowed,
once again provided theycomply with the prevailing environmental standards, and, in our view, with the Best
Practicable Environmental Option Standard.
The National Waste Management Strategy, although not necessarily binding, does assist with the practical
requirements for medical waste treatment. However government is apparently way behind schedule on
implementing the strategy, and appears to have missed most of the deadlines set in the strategy. Whether
this means there is to be a shift in the strategy with respect to medical waste remains to be seen. The
National Waste Management Act, which is currently being drafted will hopefully clarify the position.
Shepstone & Wylie
Ian Sampson
Partner, Environmental & Sustainability Law
Tel: (031) 566 – 8260 / Fax: (031) 566-2097 / Cell: 082 775 3720
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