DRAFT FOR COMMENT
Environment Agency
Technical guidance
on Clinical Waste management facilities
Version 3.0
December 2006
Comments should be sent to Peter Duffy by 8th January 2007:
peter.duffy@environment-agency.gov.uk.
1 of 48
DRAFT FOR COMMENT
Contents
1 Introduction
2 Permitted Wastes
3 Waste Acceptance, Labelling and Tracking
4 Waste Storage
5 Validation
6 Emissions Monitoring
Appendix A : Site Commissioning Methodology
Appendix B : Routine Efficacy Monitoring
Appendix C : Emissions Monitoring and Benchmarks
Appendix D : Modern Regulation
2 of 48
DRAFT FOR COMMENT
1: Introduction
This guidance is an update to version 2.5 of the Technical guidance on Clinical
Waste Management facilities. It provides additional information on the principles to
be applied to Alternative Treatment processes (i.e. thermal and chemical) for
rendering safe infectious healthcare waste (Clinical Waste). It does not cover
incineration. This guidance is intended to incorporate the technical issues recently
consulted upon in the supplement to Sector Guidance Note IPPC S5.06.
The overarching principles of Waste Management Licensing should be applied to the
Alternative Treatment processes that require a Waste Management Licence,
however this guidance identifies some additional and alternative standards to be
applied to Alternative Treatment plants.
1.1 Application of this document.
The document is non-statutory guidance applicable to activities that fall within Waste
Management Licensing Legislation and does not apply to sites regulated under a
Pollution Prevention and Control Permit.
Sections 2 and 5, Appendices A,B, and D apply only to treatment.
Sections 1, 3 , 4 and 6, and Appendix C apply to both treatment and transfer.
1.2: Definition of Clinical Waste
Clinical Waste is defined in the Controlled Waste Regulations 1992 as:
“(a) any waste which consists wholly or partly of human or animal tissue,
blood or other body fluids, excretions, drugs or other pharmaceutical
products, swabs or dressings, or syringes, needles or other sharp
instruments, being waste which unless rendered safe may prove hazardous
to any person coming into contact with it; and
(b) any other waste arising from medical, nursing, dental, veterinary,
pharmaceutical or similar practice, investigation, treatment, care, teaching or
research, or the collection of blood for transfusion, being waste which may
cause infection to any person coming into contact with it”
Healthcare waste is a waste classified under Chapter 18 of the List of Wastes, which
is waste from natal care, diagnosis, treatment or prevention of disease in
humans/animals. Examples of healthcare waste include:
 infectious waste;
 laboratory cultures;
 anatomical waste and animal carcasses (infectious/non-infectious);
 sharps waste (radioactive, cytotoxic and cytostatic, medicinally contaminated,
body fluid contaminated);
 medicinal waste (cytotoxic and cytostatic, other);
 chemicals (occur both as ‘laboratory smalls’, and diagnostic reagents/sample
preservatives in healthcare waste streams);
 offensive waste (non-infectious);
 amalgam;
3 of 48
DRAFT FOR COMMENT
The relationship between the definitions of healthcare waste and clinical waste is as
follows:
(i)
Healthcare waste includes wastes that are not hazardous, for example noninfectious hygiene wastes from patients. This waste would NOT be classed as
clinical waste.
(ii)
Clinical waste can be produced from activities other than those included in
Chapter 18 of the List of Wastes e.g. from body piercing, or arising as drug
litter. This waste would NOT be classed as healthcare waste
(iii)
Healthcare wastes that present a hazard are also clinical wastes.
With the introduction of the Hazardous Waste Regulations, the List of Wastes
Regulations, the reduction in incineration capacity, and the introduction of nonincineration technologies, it is therefore now necessary to consider clinical waste in
terms of:
 hazardous and non-hazardous waste, and
 List of Wastes classification, and
 appropriate disposal option (incineration / alternative treatment)
rather than as the broad A-E groups indicated in the Safe Disposal of Clinical Waste
1999.
Adequate source segregation should reduce the amount of healthcare waste that is
classified as clinical waste, and therefore the quantity of healthcare waste that
requires rendering safe. Technical Guidance WM2 provides the guidance on the
definition and classification of hazardous waste.
1.3 Definition of Alternative Treatment
Alternative Treatment includes treatment by heat, chemicals and irradiation in order
to render clinical waste safe. At present, this mostly relates to treating infectious
clinical waste to render it safe by disinfecting it.
Thermal treatment uses heat to inactivate pathogenic micro-organisms. Heat
treatment can be broadly divided into two groups.
1) ‘Moist’ heat processes that generate steam, including autoclaves, steam augers,
and some microwaves
2) ‘Dry’ heat processes utilising electricity, hot-oil and some microwaves, which rely
partially on moisture already within the waste.
Chemical treatment utilises disinfectants (e.g. sodium hypochlorite, chlorine dioxide,
peracetic acid, glutaraldehyde, calcium oxide or quaternary ammonium compounds).
Treatment of clinical waste by gamma irradiation has also been used.
Emerging technologies, for example hot alkaline hydrolysis, may have scope to treat
other hazardous components of clinical waste, beyond just disinfection. Potentially
this provides for a broader range of waste types that could be treated.
Explanation and discussion of various technologies is beyond the scope of this
document. Further information can be found from the following sources
4 of 48
DRAFT FOR COMMENT
-
Healthcare without harm,
Non-incineration Medical Waste Treatment
technologies, http://www.noharm.org/europe/medicalwaste/nonincineration
World Health Organisation, Safe management of Wastes from Healthcare
Activities. http://www.healthcarewaste.org/en/documents.html?id=1
These documents are presented as information resources only. This guidance
document is considered to take precedence over these for the purpose of the
regulation of clinical waste in England and Wales.
5 of 48
DRAFT FOR COMMENT
2: Permitted Wastes
2.1: Definition of Rendering Safe
Rendering safe is defined in the Department of Health document ‘Safe management
of healthcare waste’ as treatment that:
a.
for infectious waste – has demonstrated the ability to reduce the number of
organisms present in the waste to a level that no additional precautions are
needed to protect workers or the public against infection by the waste;
b.
for anatomical waste – destroys any human tissue, organ or body part so that it
is ruined, torn apart, or mutilated through processes such as thermal treatment,
melting, shredding, grinding, tearing, or breaking such that it is no longer
generally recognisable;
c.
for any clinical waste – renders any syringes, needles or any other equipment
or item unusable and no longer in their original shape and form;
d. for medicinal waste – destroys the component chemicals.
2.2: Wastes Suitable for Alternative Treatment (Disinfection)
The purpose of Alternative Treatment (Disinfection) is to render infectious waste
safe. Therefore the wastes to be treated should have properties that require
rendering safe and have properties capable of being rendered safe by Alternative
Treatment. If other wastes are to be treated using Alternative Treatment the reasons
for treating this waste should be fully justified.
The wastes listed in Table A2.1 below are identified in the European Waste
Catalogue (EWC) as hazardous because they are infectious (Hazardous Property
H9). Alternative Treatment should be restricted to these wastes unless the Licence
holder can justify the treatment of other wastes. Guidance on how to determine if a
waste falls within either of these codes is given in Appendix C of WM2: C9
Assessment of Hazard H9: Infectious.
Table 2.2 – Wastes Suitable for Alternative Treatment
EWC Code
Description of Code Description
18 01
Waste from natal care, diagnosis, treatment or prevention of
disease in humans
18 01 03*
Waste whose collection and disposal is subject to special
requirements in order to prevent infection
18 02
Waste from research, diagnosis, treatment or prevention of
disease involving animals
18 02 02*
Wastes whose collection and disposal is subject to special
requirements in order to prevent infection.
20 01
Separately collected fractions (except 15 01)
20 01 99
Other fractions not otherwise specified
(Separately collected fractions of municipal clinical waste whose
collection and disposal is subject to special requirements in order
to prevent infection. This may include waste from tattoo parlours,
body piercing and blood contaminated clothing.)
6 of 48
DRAFT FOR COMMENT
Wastes within these codes are infectious and require rendering safe. However, some
wastes that may fall within these codes are not suitable for Alternative Treatment
(disinfection) and some of these are discussed below.
2.3: Wastes Unsuitable for Alternative Treatment
The following wastes are specifically excluded from alternative treatments, even if
they fall within the codes identified in 2.2. Waste Management Licences should
specifically exclude the following wastes from the treatment process:
Table 2.3– Wastes Unsuitable for Alternative Treatment
Description
Reason
Pharmaceutical waste in any form or
Disinfection technologies have no
container (particularly sharps boxes),
recognised action against
including medicinally contaminated
pharmaceutical molecules.
syringes.
Cytotoxic and cytostatic contaminated
waste.
Anatomical waste and carcasses in any
The Department of Health, document
form
‘Safer management of healthcare waste’
states that ‘the treatment of anatomical
waste requires that the waste be
rendered unrecognisable in suitable
licensed facilities, which at this time
means incineration.’
All microbiological cultures from any
See note below on standards for
source and any potentially infected
treatment of certain Biohazardous
waste from pathology departments and
wastes.
other clinical or research laboratories
(unless autoclaved before leaving the
Guidance should be sought from the
site of production).
Health and Safety Executive before such
wastes are moved (in untreated form)
Any waste from containment level 3
from the premises of production.
laboratories
Any waste contaminated with UN
transport Category A or ACDP hazard
Group 4 pathogens
Sharps may only be subject to Alternative Treatment where the following criteria
have been met:
 No sharps or other material contaminated with cytotoxic and cytostatic medicines
are present in the sharps box.
 No pharmaceutical waste is present in the box. The syringe body is considered to
be a pharmaceutical waste when contaminated with, or containing residual
quantities of medicines (some pharmaceutical waste, and manufactured pre-filled
syringes are both sharps and pharmaceutical waste, and are therefore not
suitable for alternative treatment). This means that medicinally contaminated
syringes are not suitable for alternative treatment and must not be introduced
into these processes.
The Environment Agency no longer issues licenses on the basis of ‘fully discharged’
syringes or sharps for the following reasons:-
7 of 48
DRAFT FOR COMMENT





This position was adopted solely for the purposes of consignment under the
Special Waste Regulations 1996. These regulations have now been revoked,
and the position has not been carried forward.
Audits of healthcare producers in England and Wales has confirmed that
waste producers rarely produce and segregate such waste, and where they
do other issues listed here are highlighted.
This may encourage secondary handling of syringes resulting in an increased
risk of needlestick injuries in producer premises.
This may encourage discharge of active pharmaceuticals to foul sewer that
may result in harm to the environment or human health.
License conditions relating to this term are difficult to enforce, giving rise to
significant potential of inappropriate disposal of waste pharmaceuticals.
Certain Biohazardous waste represent either a heightened risk, require a higher
level of treatment, are categorised as a Category A waste for transport, or are subject
to guidance from the Health and Safety Executive with respect to treatment on the
site of production. The following additional criteria apply to their acceptability at
alternative treatment (disinfection) facilities
 No wastes containing ACDP 4 pathogens are suitable for treatment
 No waste containing other listed unsuitable wastes are suitable for treatment.
 Processes employing physical treatment (maceration/shredding) of untreated
wastes are unsuitable.
 A higher level of treatment (STAATT level IV criteria) is required for such
wastes.
Such wastes should not routinely leave the premises of production in untreated form,
and should only arrive at an alternative treatment facility as a ‘one off’ where
treatment at the site of production has temporarily broken down.
2.4: Other waste streams.
Treatment for Pharmaceutical Wastes, and materials contaminated with
pharmaceuticals, requires that all pharmaceutically active substances present in the
waste, both hazardous and non-hazardous, should be destroyed during treatment. At
present, high temperature incineration is the primary method of achieving this. It is
possible that future alternative technologies, for example alkaline hydrolysis, may
demonstrate treatment efficacy in this Area. In general this would require laboratory
trials to demonstrate that process parameters are theoretically able to treat a very
broad range of representative pharmaceutical molecules before testing protocols for
device based trials could be considered.
The disposal options for Anatomical waste are currently restricted to Incineration for
ethical reasons. It is not considered appropriate or acceptable to shred and
thermally/chemically treat anatomical waste. Novel technologies like alkaline
hydrolysis that dissolve, and therefore utterly destroy, the tissue leaving a ‘bone
shadow’ equivalent to incinerator ash may be applicable for such wastes.
Treatment of non-infectious waste. Where the waste does not possess the
hazardous property H9 Infectious, there it is unlikely that there is any benefit in
subjecting such waste to a process that is designed to reduce infectivity. Licences
should not be issued for treatment of such wastes unless the licence holder provides
justification. Issues to consider
 Non-infectious wastes are likely to have a high moisture content (high specific
heat capacity) or high organic content which can present additional and
8 of 48
DRAFT FOR COMMENT


significant problems for the thermal and chemical treatment process.
Validation protocols would therefore have to include a specific high organic
challenge load.
The mixing of hazardous waste with non-hazardous waste is contrary to the
principles of the Hazardous Waste Directive. Licences should not be issued
that allow mixing of clinical (infectious) waste with non-infectious waste during
the treatment process.
Is the waste being incorrectly described as non-hazardous/non-infectious ?
For example clinical waste is hazardous waste with only two exceptions; where
is a non-cytotoxic and cytostatic medicine, or where it is infectious clinical
waste that arises as a separately collected municipal fraction and is therefore
classified by the List of Wastes as non-hazardous under 20 01 99.
An example of where treatment of non-infectious waste, separately from infectious
waste, may be appropriate is
 Where the licence holder can demonstrate that treatment of non-infectious
waste is necessary to reduce the number of non-pathogenic microorganisms
present in the waste to facilitate its recycling. Such treatment may be justified
as part of an authorisation of a genuine recycling or recovery operation.
9 of 48
DRAFT FOR COMMENT
3 : Waste Acceptance, Labelling and Tracking
In developing the guidance the following have been considered:



The examination of healthcare wastes by the carrier or consignee is severely
limited by health and safety concerns.
Producer segregation is often poor resulting in a mixed waste
Paperwork descriptions have often historically been completed by the carrier,
and frequently contains insufficient information for subsequent holders to
discharge their duty of care. Particularly where waste passes through
intermediary destinations and new paperwork is generated.
The composition of the waste accepted at the site must be determined by either:1. Producer Audit - The Safe Management of Healthcare Wastes identifies the
role of robust producer audit. The Environment Agency considers that the
robust producer audits (as specified in 3.1) are the safest and most effective
means of ensuring that the waste facility has sufficient information to conduct
appropriate waste acceptance procedures in conjunction with the more
cursory checks specified in 3.2. This section provided guidance on this option.
OR
2. Waste Composition Analysis - the licence holder could in theory inspect the
contents of all waste containers (sharps boxes, rigid bins, yellow bags etc) to
confirm that the contents comply with the permitted wastes. Such on site audit
facilities have previously been authorised in England and Wales. The
Environment Agency does not recommend or support this option due to the
potential for both Health and Safety Issues and Emissions to arise. No further
guidance is provided in this section with regard to this option.
To facilitate Producer Audit criteria all waste collections and deliveries should be prearranged and supervised by someone technically aware of the waste types permitted
for the transfer or treatment operations on the site.
Waste acceptance is divided into two stages
- Acceptance procedures prior to delivery.
- Acceptance procedure on delivery
The following Table sets out the Waste Acceptance, Tracking and Labelling
requirements for Clinical Waste only.
3.1 : Stage 1 - Prior to delivery (producer audit option)
1. From the waste disposal enquiry the Licence holder should obtain information in writing
relating to:
 The details of the healthcare waste producer
 The specific process from which the waste derives – veterinary, primary care, dental,
acute, laboratory etc.
 The quantity of each waste type
 Compositional audit analysis of the waste (individual constituents of each waste
stream and their percentage compositions and chemical/pharmaceutical
contaminants)
10 of 48
DRAFT FOR COMMENT
 The form the waste takes and the types of containers used (colour, form and size of
container and sub-containers)
 Hazards associated with the waste and its components.
 Date of production of the waste and waste storage and preservation techniques used
since production (for example cold storage, or freezing, that may impede treatment.)
2. Unless an audit analysis has already been completed and the Licence holder has
sufficient written information to support this, the Licence holder should in every case
obtain representative audit analysis of the waste from the premises of production /
current holder and compare it with the written description to ensure that it is consistent.
The audit data should be less than 18 months old.
3. The type of information that would demonstrate the reliability of the audit includes:
 A diagram of the producer premises indicating the location, numbers, types and
capacities of waste containers in use.
 A list of the different wards, departments, or functional areas that exist within the
premises.
 A list of those areas that were included within the audit, and the containers within
those areas that were examined.
 A date and description of the audit and the procedures employed.
 A confirmation of the number of containers of each type audited and a detailed list of
the contents and labelling of each.
 Compositional audit analysis of the waste (individual constituents of each waste
stream and their percentage composition and chemical/pharmaceutical
contaminants).
 The waste classification and disposal options for the constituents of each stream.
 Where relevant, the audit should include examination of the segregation of waste
containers placed in on site bulk containers (e.g. 770 litre carts).
 A summary report indicating the findings for each area in the producer premises and
each waste stream produced there.
4. For pure product chemicals, laboratory smalls, or pharmaceutical waste containers, the
audit can include reference to product data sheets or an extrapolation of information on
product data sheets.
5. Following characterisation of the waste, a technical assessment should be made of its
suitability for treatment or storage to ensure compliance with licence conditions.
6. Wastes should not be accepted at the site without a clear method or defined treatment
and disposal route being determined in advance.
7. There must be a clear distinction between sales and technical staff roles and
responsibilities. If non-technical sales staff are involved in waste disposal enquiries, then
a final technical assessment prior to approval should be made. It is this final technical
checking that should be used to avoid build-up of accumulations of wastes.
8. All records relating to pre-acceptance should be maintained at the site for crossreference and verification at the waste acceptance stage. These records should be kept
for a minimum of 2 years, or 3 years where required by the Hazardous Waste
Regulations.
11 of 48
DRAFT FOR COMMENT
It is not unusual for the licence holder to also act as the carrier and collect the waste
from the producer’s premises. In these instances, this can be the initiation of the
second waste acceptance stage. Waste acceptance must ensure that there are 2
levels of acceptance, the first being acceptance checking and the higher level being
that of audit.
Clinical waste is usually bagged or sealed in UN approved packaging and then
placed in larger carts for transportation. The contents of all carts should be visually
inspected upon receipt to ensure that the carts do not contain obvious nonconforming wastes (for example waste containers of a type associated with an
unsuitable waste, or waste types/containers not identified specifically on the
documentation).
Where it is not possible to determine visually that non-conforming wastes are absent,
procedures must be put in place to unload the cart, with due consideration for both
emissions and health and safety. If it is not possible to unload the cart to achieve this,
then the waste must be sent for incineration.
The following box includes indicative standards for Clinical Waste only.
3.2: Stage 2 - Procedures when waste arrives at the facility (producer audit
option)
1. On arrival loads should:
 Be weighed unless alternative reliable volumetric systems are available
 Not be accepted into site unless sufficient storage capacity exists and the site is
adequately manned
 Have all documents checked and approved, and any discrepancies resolved before
the waste is accepted
2. Where possible confirmatory checks should be undertaken before offloading where
safety is not compromised. Visual inspection of the waste within the ‘carts’ must in any
event be carried out immediately upon offloading at the site.
3. Every container should be checked to confirm quantities against accompanying
paperwork. All containers should be clearly labelled and should be equipped with well
fitting lids.
4. At this stage the waste tracking system should begin. A unique reference number should
be applied to each container. Each container should also be labelled with the date of
arrival on site.
5. The Licence holder should ensure that waste delivered to the site is accompanied by a
written description of the waste describing its composition, hazard characteristics and
handling precautions, compatibility issues, and information specifying the original waste
producer and process.
6. Documentation provided by the driver, written results of acceptance analysis, details of
offloading point or off-site transfer location should be added to the tracking system
documentation.
7. A record of the inspection regime for each load and justification for the selection of this
option should be maintained at the site.
12 of 48
DRAFT FOR COMMENT
8. Should the inspection or analysis indicate that the wastes fail to meet the acceptance
criteria then such loads should be stored in a dedicated quarantine area and dealt with
appropriately. The maximum storage time for such loads should take account of the
potential for odour generation and insect infestation. In all cases the maximum storage
time for waste that has failed to meet the acceptance criteria should be five days working
days. Written procedures should be in place for dealing with wastes held in quarantine,
together with a maximum storage volume.
9. The offloading, sampling point/reception and quarantine areas should have an
impermeable surface with self-contained drainage, to prevent any spillage entering the
storage systems or escaping off site. All surfaces should be of sufficient type and quality
to allow effective disinfection.
10. The Licence holder should have clear and unambiguous criteria for the rejection of
wastes, together with a written procedure for tracking and reporting such nonconformance. This should include notification to the customer/waste producer and
Regulator. Written/computerised records should form part of the waste tracking system
information. The licence holder should also have a clear and unambiguous policy for the
subsequent storage and disposal of such rejected wastes. This policy should achieve the
following:
 Identifies the hazards posed by the rejected wastes
 Labels rejected wastes with all information necessary to allow proper storage and
segregation arrangements to be put in place
 Segregates and stores rejected wastes safely pending removal
11. The waste tracking system should hold all the information generated during preacceptance, acceptance, storage, treatment and/or removal off-site. Records should be
made and kept up to date on an ongoing basis to reflect deliveries, on-site treatment and
despatches. The tracking system should operate as a waste inventory/stock control
system and include as a minimum:
 Date of arrival on-site
 Producers details
 All previous holders
 A unique reference number
 Pre-acceptance and acceptance analysis results
 Package type and size
 Intended treatment/disposal route
 Accurate records of the nature and quantity of wastes held on site, including all
hazards and identification of primary hazards
 Where the waste is physically located in relation to a site plan
 Where the waste is in the designated disposal route
 Identification of licence holders staff who have taken any decisions re acceptance or
rejection of waste streams and decided upon recovery/disposal options
12. All records relating to pre-acceptance should be maintained and kept readily available at
the site for cross-reference and verification at the waste acceptance stage. Records
should be held for a minimum of two years after the waste has been treated or removed
off site.
13. The system adopted should be capable of reporting on all of the following
 Total quantity of waste present on site at any one time
 Breakdown of waste quantities being stored pending treatment
 Indication of where the waste is located on site relative to a site plan
 Comparison of quantity on site against total permitted
13 of 48
DRAFT FOR COMMENT

Comparison of time the waste has been on site against permitted limit
14. Back up copies of computer records should be maintained off-site.
15. Wastes should not be accepted at the site without a clearly defined method of recovery
or disposal being determined and sufficient capacity being available. These checks
should be performed before the waste acceptance stage is reached.
16. There must be a clear distinction between sales and technical staff roles and
responsibilities. If non-technical sales staff are involved in waste enquires then final
technical assessment prior to approval should be made. It is this final technical checking
that should be used to avoid build up of accumulations of wastes and to ensure that
sufficient capacity exists.
14 of 48
DRAFT FOR COMMENT
4
Waste Storage and Disinfection
The following guidance on the handling and storage of clinical waste are made in
addition to the recognised standard requirements that apply generally to waste
facilities and are intended to reduce the potential for
 Spillage, resulting in the release of aerosols and litter.
• Odour.
• Infestation by pests.
• Interference by trespassers.
4.1 Handling of Waste on Arrival.
Good practice is for waste to be transported in rigid leak proof containers.
Any waste arriving without such containers, e.g. loose yellow bags, should be
unloaded from the delivery vehicle directly into rigid leak proof containers for
transport around the site.
The integrity of waste packaging should be protected at all times.
Waste should not be unloaded from rigid leak proof containers after arrival on site to
facilitate onward transport.
4.2 Separation of waste types
There should be demarcated storage areas for different waste streams to ensure that
the wastes streams are not mixed. In particular the following must be kept separate
from other wastes:
Bagged clinical waste

Waste containing chemicals







Anatomical wastes
Cytotoxic and cytostatic medicine contaminated waste.
Waste medicines.
Amalgam
Sharps boxes
Non-clinical offensive/hygiene wastes
Treated outputs waste from the process.
A separate, secure and clearly labelled Quarantine Area should be provided for
waste that the facility is not authorised to accept for treatment or transfer.
4.3 Storage of Waste
All clinical waste should be kept in totally enclosed, clearly labelled and secure areas
Sited on an impermeable pavement with sealed or foul drainage system.
Sharps boxes may be stored either in
15 of 48
DRAFT FOR COMMENT


Leakproof rigid containers the lids of which shall be kept closed when the bin
is not being loaded or unloaded, or
a designated secure area of a building.
Anatomical waste and any wastes with the potential to produce odours should be
stored securely in designated refrigerated units within a building.
Chemical and pharmaceutical waste should be stored within a designated secure
area of a building in manner that is consistent with their chemical properties.
(REFERENCE?)
Other wastes should be stored in leak proof rigid containers the lids of which shall be
kept closed when the container is not being loaded or unloaded.
Waste in rigid packaging, e.g. anatomical waste, sharps and pharmaceutical waste,
should be stored in an upright and controlled manner to minimise the potential for
spillages. Note that certain sharps boxes may not be designed to retain fluids, and
may therefore release fluids if stored or handled in an inappropriate manner.
Treated waste outputs from the process should be stored in enclosed containers that
prevent its escape. The wastes should be identified and handled as difficult wastes
warranting specific handling procedures, for example, at a landfill site such
procedures may include directing the wastes to the base of the working face for
immediate cover.
Routine monitoring of waste stored on-site should be carried out by checking and
recording storage facilities to ensure that bags or containers are intact and there is
no leakage of any fluids. The manner in which waste is store should facilitate this.
4.4: Cleaning of Storage Areas and containers
The surfaces of the storage areas should be of sufficient type and quality to allow
effective disinfection.
Site surfaces and the surfaces of fixed storage containers should be cleaned and
disinfected regularly.
Once emptied all re-usable mobile rigid containers should be checked to ensure all
waste has been removed. These containers should be cleaned and disinfected
appropriately after use, and in particular on each occasion prior to their removal from
the site, in order to prevent fugitive emissions entering the hospital environment.
Wash waters must be contained within an impermeable area to prevent flow of runoff into external areas or to surface water drains. Wash waters must be drained to
foul sewer or disposed of appropriately.
4.5: Compaction of clinical waste
There should be no compaction of clinical waste.
Compaction of non-clinical offensive/hygiene wastes has the potential to produce
emissions and is not considered best practice.
16 of 48
DRAFT FOR COMMENT
Any compaction procedure for non-clinical offensive/hygiene should take place on an
impermeable surface and must both minimise the release of and include the
monitoring for the release of; Micro-organisms,
 Bio-aerosols and
 liquid discharges.
4.6: Duration of Storage
Clinical Waste has the potential to produce odour and to attract vermin or pests if the
waste is not processed directly upon arrival at a transfer or treatment site. This
depends on a number of factors including the
 age of the waste,
 type of waste,
 ambient conditions, and
 integrity of packaging
As a result no particular storage time should be specified in a licence. It is
recommended that that licence conditions are used to control any potential problems
arising from the storage of clinical waste e.g. odour and vermin.
The site operating procedures should however
 indicate the maximum duration of storage for each waste type accepted by
that facility for treatment or onward transfer. It is recommended that this
should be no longer than 14 days for pharmaceutical waste, and 7 days for
any other waste stream.
 Facilitate the treatment of waste in rotation based on identification of its age
on arrival and duration of storage on site.
Where waste is sent for onward transfer it should be sent directly to the final
treatment or incineration facility to reduce the potential for extended residence times,
and generation of odour, elsewhere in the waste chain.
4.7: Contingency
Technical breakdowns are not uncommon at clinical waste treatment facilities. Where
they have occurred this may result in excessive, inappropriate and prolonged storage
and potential breaches of a range of licence conditions.
Cessation of treatment or waste acceptance at the treatment plant may cause similar
problems at the transfer stations that supply the treatment plant.
Both treatment and transfer sites should
 not accept waste without a clearly defined method of recovery or disposal
being determined and sufficient capacity being available. These checks should
be performed before the waste acceptance stage is reached.
 ensure that they have formal contingency plans in place to maintain
compliance with licence conditions and routine operating procedures. This
should include alternative disposal sites for waste, with due consideration of
waste rejection procedures under the Hazardous Waste Regulations. The
contingency plans should not refer to other sites or companies without
documented agreement from those parties to act as the contingency.
17 of 48
DRAFT FOR COMMENT
4.8: Site access and security
Certain clinical wastes present particular security concerns.



The waste facility should be securely fenced and gated to prevent
unauthorised external access.
A security co-ordinator should be appointed to ensure that good practice
security arrangements are in place at the site. Such measures may include
alarms, CCTV and use of security guards as appropriate to the location, scale
and type of facility.
Facilities handling Group D waste will need to operate a higher degree of
security and record keeping to prevent unauthorised tampering with, or theft
of pharmaceuticals.
18 of 48
DRAFT FOR COMMENT
5: Treatment Efficacy for Alternative Treatment Processes
5.1 : Introduction
The fundamental principle of any Alternative Treatment (Disinfection) is that it
renders infectious clinical waste safe i.e. it removes that hazard that makes the waste
clinical waste. The efficacy of a particular treatment process is a measure of its ability
to render clinical waste safe.
There are three stages in the Quality Assurance of treatment efficacy.
1. Process Efficacy Testing – to demonstrate that the intended process, for
example the one to which a licence application relates, has previously been
proven to be effective elsewhere.
2. Site Commissioning Validation – to demonstrate that each device installed
on the site is able to treat the waste that is being subjected to the process,
using the parameters and operational procedures employed by that facility.
Data from the testing of one item of equipment cannot be used for an
identical item of equipment in operation in the same or different premises
as consistent construction, performance and operation cannot be
guaranteed. Generic testing of a technology, rather than individual items of
equipment, may form part of the Process Efficacy Testing but cannot be
considered for Site Commissioning Validation.
3. Routine Monitoring – ongoing monitoring of treatment efficacy to support
real time parametric records and controls.
There are four criteria that must be met to render a clinical waste safe
a. for infectious waste – the treatment must demonstrated the ability to reduce the
number of organisms present in the waste to a level that no additional
precautions are needed to protect workers or the public against infection by the
waste;
b. for anatomical waste – destroys any human or animal issue, organ or body so
that it is no longer generally recognisable.
c. for any clinical waste – renders any syringes, needles or any other equipment
or item unusable and no longer in their original shape and form (unrecognizable);
d. for medicinal waste – destroys the component chemicals.
5.2 : For infectious waste
In the USA, the State and Territorial Association on Alternate Treatment
Technologies (STAATT) has provided four levels to define the levels of microbial
inactivation required for clinical waste treatment. The 1998 STAATT guidance is
accepted by the Environment Agency as the basis of the minimum standards for the
treatment of infectious waste in England and Wales. These principles are adopted
into this guidance with consideration of domestic legislation, current knowledge, and
awareness of the forthcoming revision of the STAATT guidance.
19 of 48
DRAFT FOR COMMENT
STAATT
Level I
Description
Inactivation of vegetative bacteria, fungi and lipophilic viruses at a
6 log10 reduction or greater.
Level II
Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic
viruses, parasites and mycobacteria at a 6 log10 reduction or
greater.
Level III
Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic
viruses, parasites and mycobacteria at a 6 log10 reduction or
greater; and inactivation of B. stearothermophilus or B. atrophaeus
spores at a 4 log10 reduction or greater.
Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic
viruses, parasites and mycobacteria and B. stearothermophilus
spores at a 6 log10 reduction or greater.
Level IV
To avoid the need to test treatment plants with a range of micro-organisms it is
considered acceptable to use thermally or chemically resistant bacterial spores as
pathogen surrogates. These are substantially more resistant to treatment than most
vegetative bacteria, fungi, viruses and parasites. There inactivation can normally be
assumed to be indicative that other micro-organisms have also been inactivated.
Key requirements for Infectious Waste Treatment
1. The test to establish if the numbers or activity of pathogens has been reduced so
that no additional precautions are needed to protect workers or the public against
infection by the waste is based on the Level III criteria recommended by the State
and Territorial Association on Alternative Treatment Technologies (STAATT).
2. The level IV criteria must be met for the treatment of certain biohazardous waste
3. The above level III or IV criteria must be demonstrated for the worst-case
scenario challenge loads e.g. a rigid, 2 litre, gel-filled chest drain/suction canister.
This principle is implicit in the STAATT guidance. A worst-case challenge load
must include waste articles that are likely to be present in the waste treated at the
site that inhibit treatment. A challenge load would be expected to include items
that provide thermal insulation or prevent chemical penetration e.g. rigid 2 litre
gel filled chest drain/suction canisters. Chemical process validation should
include a high organic load challenge.
4. Where the waste is macerated or shredded prior to the thermal/chemical
treatment process, then the challenge load may be the size-reduced waste.
5. Where the waste is reduced in size as an integral process that occurs
simultaneously with the thermal/chemical process then the use of size-reduced
waste as the challenge load is not appropriate.
6. Treatment Efficacy shall be validated and tested in accordance with the
standards detailed in Appendix A.
7. The device should not process waste in a batch quantity or throughput rate
20 of 48
DRAFT FOR COMMENT
greater than that assessed during validation.
8. Mobile plant should be fully validated on commissioning and undergo
confirmatory tests before commencing operations on another site. Full validation
will be required if the device is to be resident for more than 6 months.
5.3: For anatomical waste
Alternative treatments are not considered appropriate for the treatment of anatomical
waste. This waste has three particular properties that underpin this
 The ability of tissue, during or after treatment, to generate odour
 The longer time taken treat larger pieces of tissue
 The ethical issues associated with such treatment, particularly with the
shredding of such waste.
New technologies may enter the market that have the potential to destroy either
 Anatomical waste, and/or
 Anatomical wastes contaminated with pharmaceuticals (including cytotoxic
and cytostatic medicines).
Incineration reduces anatomical waste to ash. The successful application of
alternative treatments to this waste stream must achieve the equivalent result.
Alkaline hydrolysis for example has the potential to digest the flesh from a carcass
leaving only a bone shadow.
Validation of such technologies would have to demonstrate the ability to destroy the
tissue of worst case scenario anatomical wastes.
Consideration would also have to be given to the presence of pharmaceutical and
infectious contaminants in such waste, as discussed in section 2.8.5.
5.4: For any Clinical Waste
Clinical waste that is subjected to alternative treatment may contain items or
disposable equipment that should be shredded/macerated to render it
unrecognisable and prevent its reuse. This would also act to prevent any patient
information being determined from labels within the waste.
All such treatments should be capable of reducing the waste, by maceration,
shredding or other means, to a particle size of less than or equal to 50mm with no
particle exceeding 80mm in any dimension.
Any plant that macerates/shreds clinical waste that has not already been rendered
safe should also be designed and built specifically to ensure microbiological aerosol
containment. This should include operation under negative pressure, with air drawn
away from the hopper entrance and passed through HEPA filters. Hoppers should
have doors on the opening to retain aerosols.
Microbiology laboratory autoclaves, which treat a more limited and less recognisable
range off microbiologically contaminated waste from that laboratory, on the premises
of the laboratory are not required to meet this criteria as long as either
21 of 48
DRAFT FOR COMMENT


The partially treated waste is subsequently shredded before final disposal to
landfill, or
The partially treated waste is classified as offensive waste (e.g. 18 01 04 or
18 02 03), and disposed of with additional precautions at landfill.
Treatment plants for clinical waste, other than microbiology laboratory autoclaves,
are expected to have in place procedures to achieve the particle sizes specified
above.
5.5: For Medicinal Waste
Treatment for Pharmaceutical and pharmaceutically contaminated Wastes (e.g.
sharps) requires that all pharmaceutically active substances present in the waste,
both hazardous and non-hazardous, should be destroyed during treatment.
At present, high temperature incineration is the only recognised method of achieving
this.
It is possible that future alternative technologies, for example alkaline hydrolysis, may
demonstrate treatment efficacy in this Area. In general this would require laboratory
‘process efficacy’ trials to demonstrate that process parameters are theoretically able
to treat a very broad range of representative and worst case scenario pharmaceutical
molecules before site commissioning validation protocols for device based trials
could be considered.
The temperatures required to destroy a number pharmaceuticals are known to
significant beyond those currently employed non-incineration thermal processes.
Chemical treatments should also be viewed with caution as they may result in;
No reaction with the pharmaceutical, (i.e. the pharmaceutical is untreated)

A reaction that destroys the pharmaceutical producing a non-hazardous
reaction product.

A reaction that results in the production of a hazardous reaction product.
No distinction is made in this section between the treatment of cytotoxic and
cytostatic medicines and the treatment of other medicines classified as nonhazardous in the List of Wastes. Both groups are typically designed to interact with
biological systems at very dilute concentrations and may possess a range of
hazardous properties.
‘Dilution’ with other waste or ‘small quantities’ do not equate to efficacy of treatment.
5.6 Parametric monitoring and controls
Parametric monitoring of a clinical waste treatment process should provide real-time
data acquisition for assessing efficacy.
The data acquired from the parametric monitoring device(s) must be correlated with
the requirements for rendered safe during Site Commissioning Validation.
The parametric monitoring and controls should be:-
22 of 48
DRAFT FOR COMMENT





based on automated rather than manual recording of critical parameters.
Include tamper-proof controls or automatic factory-set controllers such that
critical parameters cannot be altered during routine operations and cycle
formats other than those that have been validated cannot be used.
integrated with the treatment unit to automatically shut-down or no longer
accept or expel waste if treatment conditions are not maintained at specified
performance levels.
derived from appropriately and periodically calibrated monitoring devices
capable of accurately measuring key process parameters, for example time,
temperature, pressure, humidity, chemical volume and active agent
concentration.
5.7: Process Efficacy Testing
This is information from a similar device located elsewhere in the UK or overseas
submitted in support of a licence application to demonstrate that the proposed
technology has previously demonstrated efficacy of treatment elsewhere.
Data from sources outside the United Kingdom should be treated with a degree of
caution. In many cases the regulatory regime, guidance, licence holder procedures
and healthcare waste segregation practices will differ to extent that such data is only
an indicator of the potential performance of a device.
No criteria are set for this step, other than data relating to process efficacy testing
should be submitted with the licence application.
The purpose of collecting this information is to confirm that the technology is robust
enough for a licence to be issued, and to assist the licence holder and regulator in
identifying any known issues with the technology that might affect the next step in the
assessment, Site Commissioning Validation.
Licences for processes treating anatomical or medicinally contaminated waste should
not be issued without detailed submissions on efficacy of the process being
submitted and technically assessed by specialists.
5.8: Site Commissioning Validation
All clinical waste treatment devices must be validated once they have been installed
on site and prior to commencing treatment operations. This validation demonstrates
that the device works to the required level of treatment when employed by that
licence holder for the waste streams they accept.
This validation is valid for a maximum of 48 months, and should then be repeated to
ensure that changes in the waste stream composition and ‘wear and tear’ have not
impaired performance.
This is required for newly installed equipment and in cases where existing plant is
shut down because it failed to demonstrate routine efficacy. Validation must
demonstrate that the plant can meet the requirements of rendered safe, for example
for infectious waste - STAATT level III (or where applicable IV) using methodology
consistent with the guidance presented in this appendix A.
23 of 48
DRAFT FOR COMMENT
Waste treatment operations should not commence until the Environment Agency has
technically considered the Validation report and confirmed its agreement in writing
that the criteria have been met..
Procedures for anatomical waste, pharmaceuticals and pharmaceutically
contaminated waste are not provided. However the general principles of Appendix A
bases on statistical reproducibility and worst case scenario should be adhered to
rigorously.
Procedures for ‘unusable and unrecognisable’ – this can be conducted by physical
measurement of particle size.
NOTE : Investigations by the Overseas bodies, the National Health Service,
Health Protection Agency, and Environment Agency have identified significant
issues with previous validation methodology, and its application to many
technologies. Environment Agency officers are recommended to seek
specialist advice from NOPTS Technical Advisors before agreeing that a report
meets the standards indicated.
5.9 : Routine Monitoring
All clinical waste treatment devices should be monitored routinely throughout their
operational life to ensure that the requirements for rendered safe are met and that
this performance is maintained.
The frequency of the monitoring should consider the
 Parameters of rendered safe being monitored
 The economics of the monitoring which may relate to the throughput of the
device.
 The ease of monitoring, which may be device dependent.
 The presence of robust parametric controls and automated recording that
reduces the need for frequent monitoring.
The frequency should never however be less than annual and where any concerns or
uncertainties remain (for example due to absence of supporting monitoring data in
process efficacy submissions) should be more frequent.
Appendix B provides the minimum requirements for infectious waste, with
consideration of the above criteria, for those units that have robust parametric
controls and automated recording in line with 2.8.6.
24 of 48
DRAFT FOR COMMENT
6: Emissions & Monitoring
6.1: Introduction
Potential emissions from clinical waste sites can be divided into the following
categories
 Pathogenic micro-organisms
 Chemicals and pharmaceuticals
 Nuisance – litter, offensive litter, dust, odour and noise.
 Pests and vermin.
6.2: Pathogenic Micro-organisms
Clinical waste can be reasonably expected to contain pathogens. Although the total
number of micro-organisms (both pathogenic and non-pathogenic) may be less than
that found in domestic refuse, it is likely that a wider range of pathogens will be
present and that some of these will have the ability to either cause more severe
symptoms or possess some form of resistance to anti-microbial therapies that could
complicate treatment. These emissions must therefore be minimised and regulated.
Examples of where emissions may arise include : Emissions to air resulting from breached packaging during handling
procedures.
 Emissions to air from the process, particularly during shredding of untreated
waste.
 Transmission beyond the site boundaries by infection or contamination of
staff or visitors leading to spread in the community
 Transmission beyond the site boundaries by infection or contamination of, or
the removal of infected material by, pests or vermin.
 Transmission beyond the site boundaries by the return of contaminated waste
containers to healthcare premises.
 Transmission beyond the site boundaries by reloading bagged waste, other
than in wheeled carts, on vehicles for onward transfer in a manner that
causes breaches in the packaging.
The three main concerns are
 Release of bioaerosols
 Spillages of bodily fluids including blood, faeces, vomit, sputum, etc.
 Needlestick injuries
Aerosol emissions from point sources such as steam pressure relief valves should be
prevented by the appropriate use of high efficiency particulate air (HEPA) filters.
Indicative requirements for the control of point source emissions to air
1. HEPA filters should be effectively maintained to ensure a minimum particle removal
efficiency of 99.97% for all particles of 0.3m diameter.
2.
Procedures should be in place to allow for the safe removal and disposal of
HEPA filters.
25 of 48
DRAFT FOR COMMENT
Plant that macerates/shreds clinical waste has the potential to generate fugitive
emissions of pathogens to air. Any plant that macerates/shreds clinical waste that
has not already been rendered safe should also be designed and built specifically to
ensure microbiological aerosol containment. This should include operation under
negative pressure, with air drawn away from the hopper entrance and passed
through HEPA filters. Hoppers should have doors on the opening to retain aerosols.
Releases to foul sewer are less likely to present a risk, however monitoring of such
releases may enable identification of failures in plant integrity.
6.3: Chemicals and Pharmaceuticals
A wide range of both pharmaceuticals and chemicals is used in healthcare. These
may possess a wide range of chemical risk phrases and therefore hazardous
properties. Known issues include: Incompatible reactions, for example resulting in spontaneous combustion.
 Leakage from containers, for example sharps boxes, that are not designed to
be leak proof.
 Volatile chemicals, for example formaldehyde, released during thermal
treatments.
 Discharges of organic chemicals to foul sewer, particularly from condensers
of steam based processes.
Consideration should also be given to the discharge of disinfectants used in chemical
treatment and site cleaning processes.
6.4 : Nuisance – litter, offensive litter, dust, odour and noise.
Clinical waste, like many wastes, has the potential to generate litter. Specific
concerns relate to: Contaminated items within the waste being released with secondary
consequences.
 Items within the waste that are recognisable and may cause significant
offence, for example items of human tissue.
 Information relating to a patient, for example labelled sample containers or
patient record.
The potential for litter or dust can be reduced by transporting packaged clinical waste
both into and out of the site in large wheeled carts, and similarly treated clinical waste
in enclosed containers.
The potential to generate odour should be considered when determining the length of
time clinical waste is stored, the type of container used for storage and the
temperature at which waste is stored. On site procedures should minimise the time
between the production and final disposal of the waste. Prolonged storage and
movement from one transfer station to another are bad practice.
The mechanical components of the treatment have the potential to generate noise.
26 of 48
DRAFT FOR COMMENT
With consideration of the above points General Environment Agency guidance on the
regulation of noise, odour, dust and particulates should be followed, at the time of
publication this is
 Environment Agency Noise Guidance, Internal Guidance for the Regulation of
Noise at Waste Management facilities, version 3.0, July 2002.
 Environment Agency Odour Guidance, Internal Guidance for the Regulation
of Odour at Waste Management facilities, version 3.0, July 2002.
 Monitoring of Particulate Matter in Ambient Air around waste Facilities –
Technical Guidance Document (Monitoring) – M17, version 3.0, February
2003
6.5 : Pests and vermin
The organic constituents of clinical waste have the potential to attract insects, birds,
rodents, and other scavenging mammals in the same fashion as domestic refuse.
Live maggots are now in general use within the National Health Service for treatment
of wounds. The waste itself therefore has the potential to produce one or more
generations of flies within waste containers if conditions permit.
Additional concerns relate to
 The infection or contamination of pests or vermin by materials in the waste
 The removal of particularly offensive items of waste by pests or vermin.
It must be remembered that clinical waste streams may include
 waste from veterinary practices that presents an infection risk to other
animals, or in some cases (Zoonotic diseased) to man as well.
 Waste from human healthcare that presents an infection risk to people, or in
some cases to animals as well.
Animals may serve as a vector or reservoir of both human and animal disease.
Site Operating Procedures should include regular monitoring for pests and vermin,
and remedial actions to be taken if found.
6.6. Spilllages
6.6.1: Introduction
The primary objective is to prevent a spillage occurring through use of
 Robust waste acceptance to identify wastes on arrival, and
 Correct storage of those wastes, and
 Maintaining the integrity of waste packaging.
 Design and construction of appropriate site surfaces and drainage
Where a spillage has occurred it is important to consider the nature of the material
and the appropriate method to manage it :
 Biological contamination should be treated with disinfectants.
 Chemical or pharmaceutical contamination should be cleaned up with
appropriate chemical containment procedures. This is likely to depend on the
nature of the chemical.
 Whether the material is liquid or solid is also likely to be relevant.
Records should be kept of the time, place, nature, cause and remedial action taken
with regard to each spillage.
27 of 48
DRAFT FOR COMMENT
Further information is available from Environment Agency Pollution Prevention
Guidelines
6.6.2 : Spillage infrastructure and equipment
Waste facilities should have basic spillage equipment that is easily accessible in case
of accidental spillage. Supplies of spillage kits with suitable absorbent material must
be kept on site and all staff should be trained in their use. All site licence holders
should be aware of where the equipment is located and it should consist of:
 A suitable disinfectant
 Suitable absorbent materials.
 Scoops.
 Additional protective clothing to that already used by site licence holders.
 Disposable cloths and paper towels.
 Waste disposal bags and rigid containers to collect the spillage.
6.6.3 : Biological contamination and disinfectants
Disinfectants may have differing spectrums of activity against micro-organisms, may
possess hazardous properties, and may be affected by organic matter in the waste. It
is important that broad spectrum disinfectants are used in appropriate quantities and
concentrations, and that the potential for chemical releases or reactions is minimised.
Should a spillage occur from a clinical waste container, the liquid spill and/or the area
contaminated by solid waste should be treated with an effective chlorine based
disinfectant. Sodium dichloroisocyanurate (NaDCC) granules are recommended for
the clean-up of spillages as other made-up solutions lose activity with time and
require regular replacement. Disinfectants containing 10,000ppm (1%) available
chlorine are recommended for spillages. Suitable inert, absorbent materials may be
used to deal with liquid spillages after disinfection.
The nature of disinfectants for use in both routine cleaning and spillage clean-up
should be discussed with the trade effluent control staff of the sewage undertaking.
The impermeable surfaced areas of the facility should be regularly cleaned and
disinfected and it is recommended that, generally, this should be done on a monthly
basis. This frequency should be increased in areas prone to frequent leakage.
6.6.4: Chemical spillages
Spillages of process chemicals (for example, from chemical treatment processes) or
disinfectants should be cleaned up in accordance with recommendations on the
Manufacturers Safety Data Sheets (MSDS) and the COSHH assessments made by
the licence holder.
Spillages of fuel, oil, lube oil etc should be absorbed using appropriate spillage kits.
Once the spill has been absorbed and the adsorbent removed, surfaces should then
be steam cleaned or pressure washed.
28 of 48
DRAFT FOR COMMENT
6.6.5: Disposal of spillage materials
Once the clean-up of a spillage has been completed, the material should be
immediately placed in an appropriate container (e.g. clinical waste bag, sharps bin or
chemical spill bin). Once this has been done, the wastes should be sent for treatment
or disposal at an appropriately licensed waste facility. Depending on the nature of the
spill or the content of the chemical used to clean the spillage, the package may have
to be consigned as Hazardous Waste
6.6.6: Site Surrender criteria
It is recommended that where an application is made to surrender a waste
management licence at a clinical waste facility, other than landfills, the following
should be carried out:
 remaining wastes must be removed.
 process equipment must be thoroughly cleaned and disinfected or removed.
 storage containers must be thoroughly cleaned and disinfected and removed.
 The site must be decontaminated by thoroughly cleaning and disinfecting
hard surfaces, drains and interceptors.
The site licence holder must provide details of spillages or pollution incidents that
occurred throughout the life of the site and how they were dealt with.
29 of 48
DRAFT FOR COMMENT
Appendix A : Site Commissioning Validation for Infectious
Waste Treatment
A1: Introduction
This section contains the detailed minimum requirements for demonstration of
disinfection efficacy for Site Commissioning Validation of clinical waste treatment
device.
These are presented as
 General requirements - that apply to all plants
 Supplementary Specific procedures – that apply to different technologies.
A1: General Requirements
Validation Report
1. A validation report should contain the following elements:
i) A microbial efficacy analysis, that demonstrates that the choice of test
organism, the method of introduction to the plant, the choice of organism
carrier, and the analytical method are adequate to demonstrate STAATT level
III criteria for the worst case scenario challenge load.
ii) Evidence that effective parametric controls, and procedures for real-time
monitoring and assessment of outputs, are in place with respect to any waste
treated.
iii) Evidence that the parametric control data relates to microbial efficacy so that
waste can therefore be considered to be treated satisfactorily on the basis of
parametric controls alone.
iv) An environmental monitoring assessment of the site that addresses process
emissions, including emissions from the macerator/shredder.
v) Where procedures differ from (i) evidence that operational efficacy monitoring
regimes are effective.
2. For newly installed treatment plant operations must not commence until the
licence holder has submitted the report to the Regulator for assessment and has
received from the Regulator written confirmation that the validation report has
been agreed.
Commissioning of the Plant
3. The procedures and criteria that must be satisfied to demonstrate that treatment
can achieve the microbial inactivation aspect of ‘rendered safe’ is specified in the
following sections depending on the type of plant that is being commissioned:
 A2: Procedure for Microbial Validation for pre-maceration technologies where
spore strip integrity can be guaranteed (for examples Augers).
 A3: Procedure for Microbial Validation for pre-maceration or integral
maceration technologies where spore strip integrity cannot be guaranteed (for
example Autoclave with integral macerator).
 A4: Procedure for Microbial Validation for technologies that lack premaceration or integral maceration
4. Both the field and laboratory aspects of this procedure should be carried out by a
suitably qualified microbiologist utilising a suitably accredited laboratory.
Test Organism
5. For thermal and chemical processes the tests should be performed using either
30 of 48
DRAFT FOR COMMENT
Bacillus atrophaeus (subtilis) OR Geobacillus stearothermophilus.
6. The Licence holder should demonstrate that the choice of spore species, strain
and certification is the most appropriate for the treatment method employed.
7. A single batch number of spore strips / spore suspension should be employed
during commissioning.
8. Each batch of spores will have a certified D-value. The D-value is the time taken,
in minutes, for a 1 log10 reduction, in the number of spores exposed to specified
conditions. Not all batches of spores will have the same D-value. This D-value
may vary by up to 100% for commercially available spores of the same type, and
variance beyond this range is available on request. The choice of spore strip may
therefore increase or reduce the number of spores recovered by a factor of 10.
This can therefore alter the reported reduction by up to 2 log10.
9. To maintain consistency of treatment standard, the STAATT level III criteria
should be demonstrated using spores where the certified D-value is  2 minutes
- at 121C wet heat (Geobacillus stearothermophilus)
- at 160C dry heat (Bacillus atrophaeus)
10. Where the certified D-value of a batch of spores is < 2 minutes, or determined at
parameters other than those identified above, they are not suitable for use. This
applies to both routine monitoring and validation.
A2: Procedure for microbial validation for pre-maceration technologies where
spore strip integrity can be guaranteed (for examples Augers).
1. This applies only to those technologies that have pre-maceration and where it is
possible for the test materials to be inserted easily into the macerated waste prior
to it entering the microbial treatment process.
Spore Strip Containment
2. Spore strip challenges should be carried out on the technology using spore
carriers where the integrity of the container can be guaranteed.
3. Spore carriers should be designed to mimic normal conditions in the waste being
treated as much as possible, and the type chosen will be dependant on both the
technology and the waste treated. Examples that may be suitable include net
bags, tennis balls with holes in them, socks, plastic containers with holes in or
alloy containers with holes in.
4. Where spore strips are placed in metal containers they must always be wrapped
in a layer of cotton wool, or equivalent, to prevent direct conduction of heat from
the metal.
5. Where technologies have integral mixing it is not appropriate to attach the spore
carriers to the mixing arms because the waste is not fixed to the mixing arms i.e.
31 of 48
DRAFT FOR COMMENT
the spore carriers should be loose in the waste. The licence holder may attach up
to 50% of the spore carriers to fixed positions, however the results for these must
be assessed separately, and both fixed and loose spore carriers must pass the
criteria provided. If the licence holder can demonstrate statistically that there is no
significant difference between the two data sets, then routine operational
monitoring can use fixed carriers.
6. Similar criteria apply to the use of test ports into which spore strips can be
placed. In general these are not representative of the treatment to which the
waste is subjected and should not be used.
Outline Test Procedure
7. If the technology processes the waste in batches, the tests should be carried out
over a minimum of 5 separate treatment cycles for each cycle format. For
example where the device is operated at two different temperatures or times,
each must be validated separately using 5 cycles.
8. For continuous technologies, the tests should be done in five distinct collections
for each cycle format, with the tests for each previous collection being retrieved
from the treated waste before the next set of tests is introduced to the treatment
plant.
9. The minimum number of spore strips required is set out in table A2.1
10. Strips should be spread out in the load as much as is practicable. For
technologies with integral mixing this may be accomplished inside the machine.
For static technologies the strips should be spread out throughout the length of
the chamber, and should be placed as near the centre of the load as possible.
11. A minimum of 2 untreated control strips should be held outside the autoclave
during each cycle/batch and processed along with the tests afterwards to provide
an estimate of the numbers of spores retrievable from each strip.
12. The use of surrogate waste is not appropriate. Clinical waste of the type(s) to be
treated by the technology under normal conditions should be used for all tests.
13. All waste ‘treated’ during testing should be either:
 re-treated by another technology to ensure it is rendered safe, or
 it should be quarantined until the validation report is agreed by the Regulators
(The storage requirements in this document should be complied with).
14. For thermal processes, the microbial data should be supported by the parallel
use of thermal indicator strips or multi-point thermal data loggers to record
temperatures throughout the waste load. These strips should be chosen to
support the parametric controls and measure both temperature achieved, and
duration of exposure to that temperature.
Laboratory Methods
15. These will be partly determined by the test organism, the method specified by the
32 of 48
DRAFT FOR COMMENT
spore supplier, and reference to other guidance on microbiological methods.
16. 100% of each test sample must be analysed. This is not required for control
samples. Analysis must be quantitative.
Validation Criteria
17. This requires quantitative enumeration of spore strips with a certified population
of >1 x 106 spores per strip. Qualitative analysis and/or the use of lower numbers
are not appropriate for plant commissioning.
18. For the Control Run(s) the following are required:
 The mean number (XC) of spores recovered from the control strips should be
calculated in cfu.
 The log10 of (XC) should be determined.
19. For the Test Runs the following require determining:
 The mean (XT) number of spores recovered
 The standard deviation () of spores recovered
The log10 of (XT)

The Upper 95% (Lu) confidence interval of (XT) (this will be XT+ 1.96)

The log10 of the Upper 95% confidence interval (logLu) of XT

20. The following criteria represent the minimum standard that must be achieved:
 (log (XC)-4)  logLu
 log (XC) must be  5
For thermal processes all thermal indicator strips should indicate that the
required temperature time parameters have been achieved.
21. These criteria must include the proviso that ALL test strips, or spore samples,
recovered from the plant must be considered valid. This includes those where
contamination has occurred. Significant contamination will therefore require the
exercise to be repeated.
22. Where these criteria are passed then it is 97.5% probable that any clinical waste
will be treated to the minimum required standard.
Table A2.1: Minimum number of spore strips required for microbial validation
of Alternative Treatment Plants with Pre-maceration technologies where spore
strip integrity can be guaranteed.
Single Load Capacity
Minimum Number
Minimum
Minimum Number
(Kg)
of spore strips per Number of spore
of control strips
Continuous
cycle or collection.
strips
(for each cycle
throughput (Kg per
(for each cycle
format)
Hour)
format)
0-10 kg
3
15
10
33 of 48
DRAFT FOR COMMENT
11-50 kg
51-250 kg
251-500kg
501-750kg
>750 kg.
6
9
12
15
18
30
45
60
75
90
10
10
10
10
10
A3 : Procedure for microbial validation for pre-maceration or integral
maceration technologies where spore strip integrity cannot be guaranteed (for
example Autoclave with integral macerator).
1. This applies to those technologies with integral maceration, or pre-maceration
that cannot easily be by-passed. It does not apply to those technologies with
integral mixing or fragmentiser arms that do not meet the definition of maceration.
(e.g. Hydroclaves and Rotaclaves.)
2. The ‘fixing’ of spore strips, in such a way as to bypass the integral maceration
process, is not considered to be appropriate. This may overestimate the efficacy
of the treatment process and is not representative of the processes to which the
waste is subjected.
3. Where the integrity of the containers cannot be guaranteed, it is necessary to use
spore suspensions.
4. The spore suspension is mixed with the waste before treatment, and sufficient of
the treated waste is collected after treatment to allow a numerical count of the
number of surviving spores to be made. For each run the spore suspension
should be placed in at least 6 discrete portions in representative challenge waste
items, for example inside syringe bodies in sharps boxes, inside suction canisters
or chest drains etc.
5. This procedure requires:
 One control run, where waste is passed through the device with the
thermal/chemical treatment inactivated. This provides an estimate of spore
recovery from the waste.
 Then three test runs should be performed for each treatment cycle format.
These data are compared with the control run to provide an estimate of
treatment efficacy.
6. The control run is required because of the ‘natural’ loss of spores with this
procedure due to absorption or trapping of spores in the materials in the waste,
the dilution factor, and the inadequacies of the retrieval and concentration
process.
7. For chemical processes, it is essential that the device be thoroughly cleaned to
remove residual traces of disinfectant prior to conducting control runs.
8. For health and safety reasons it may be appropriate to use for the control run
either:
 A batch of treated clinical waste, or
 A prepared batch of clinical waste composed of uncontaminated items
34 of 48
DRAFT FOR COMMENT
Required testing parameters
9. For thermal processes the waste should be seeded with sufficient of a > 1 x
1010ml–1 spore suspension to achieve at least 1 x 106 spores per gram
throughout the load. (this equates to at least 0.1 ml per kg of waste). Geobacillus
stearothermophilus is strongly recommended in order to reduce the interference
from other microbes.
10. Sub-samples of the treated waste should be collected from throughout the load
and analysed separately
- 0-50 kg per cycle/hour – test using a minimum of 3 sub-samples per
cycle/batch
- 50-500 kg per cycle/hour – test using a minimum of 4 sub-samples per
cycle/batch
- >500 kg per cycle/hour – test using a minimum of 5 sub-samples per
cycle/batch
11. Each sub-sample should equate to at least 0.1% of the waste load, with the
minimum sub-sample size set at 50g for smaller units. The sub-sample size
should equate to at least 1 x 107spores.
12. Analysis is complex, the following being an indication of a typical procedure
rather than an approved and accredited method. Expert advice should be sought
before conducting such analysis.
 Samples should be appropriately preserved until received by the laboratory
and subjected to testing. The testing must commence within an appropriate
time scale. The entire sub-sample is mixed with excess sterile physiological
saline for at least 15 minutes on an orbital shaker. (Note that neutralising
buffer may be required for chemical treatments)
 The liquid is decanted through a sterile coarse fabric filter to remove solid
waste.
 The liquid is centrifuged at 3000g for 20 minutes to deposit the spores.
 The deposit is resuspended in 10 ml of brain heart infusion broth (BHI).
(additional washing of the deposit in saline/buffer may be necessary prior to
this step)
 Serial dilutions are made in BHI from 1:10 to 1: 1,000,000
 These should be analysed in triplicate in thick pour plates
 Plates are incubated in a moist chamber at 60°C for up to 7 days.
13. For thermal processes the microbial data should be supported by the parallel use
of thermal indicator strips or multi-point thermal data loggers to record
temperatures through out the waste load wherever possible.
Validation Criteria
14. This requires quantitative enumeration of the sub-samples relative to the control
run. Qualitative analysis or the use of less than 1 x 106 spores per gram is not
appropriate.
15. For the Control Run(s) the following are required
 The mean number (XC) of spores recovered from the control samples should
be calculated in cfu.
 The log10 of (XC) should be determined.
16. For the Test Runs the following require determining
35 of 48
DRAFT FOR COMMENT





The mean (XT) number of spores recovered
The standard deviation () of spores recovered
The log10 of (XT)
The Upper 95% (Lu) confidence interval of (XT) (this will be XT+ 1.96)
The log10 of the Upper 95% confidence interval (logLu) of XT
17. The following criteria represent the minimum standard that must be achieved:
 (log (XC)-4)  logLu
 log (XC) must be  5
For thermal processes all thermal indicator strips should indicate that the required
temperature time parameters have been achieved.
18. These criteria must include the proviso that ALL test strips, or spore samples,
recovered from the plant must be considered valid. This includes those where
contamination has occurred. Significant contamination will therefore require the
exercise to be repeated.
19. Where these criteria are passed then it is >97.5% probable that any clinical waste
will be treated to the minimum standard.
A4 : Procedure for microbial validation for technologies that lack premaceration or integral maceration
1. These technologies may have severe limitations and may lack the technical
ability to treat a worst-case scenario challenge load of clinical waste.
Environment Agency officers should always seek specialist advice before issuing
an authorisation, or other approval, for such technologies.
2. Where there is no physical action to enable sealed waste containers, and sealed
voids in the waste to be punctured, then the treatment is unlikely to penetrate the
waste fully.
3. In general, specialist challenge load testing using methodology consistent with
that developed by the Health Protection Agency would be required to confirm
efficacy. This is beyond the scope of this document.
4. Static autoclaves, including those with vacuum cycles, are particularly affected by
this issue and the waste will require either
 Some form of physical pre-treatment (e.g. maceration), and/or
 an extended cycle duration
to enable effective treatment to take place.
5. As an indicator of methodology requirements, spore strips should be placed in
each of the following:
 Robust rigid 2 litre suction canister/chest drain containers made of
thermostable plastic, of variable types containing 1-1.5 litres of fluid and
thermally stable gel. The licence holder should demonstrate that the type(s)
chosen represent the worst case challenge load., and
 Any other challenging items identified by audit where the penetration of the
steam/chemical may be inhibited (for example lengths of tubing, inside
36 of 48
DRAFT FOR COMMENT
syringe bodies in sealed sharps boxes etc).
6. Testing should cover 18 - 36 suction canisters and chest drains (in 3-6 test runs
per plant), including approximately 6 of each type/brand, each containing two
biological indicator strips and two thermal indicator strips.
7. These containers should be placed in rigid containers and/or yellow bags of the
type to be taken by the plant, and to reflect normal operations, and mixed with a
typical waste load.
8. The validation criteria from section A3, 17-22 should be applied.
Commercial Off-site Treatment Facilities
9. Commercial treatment facilities receiving waste from producers located
elsewhere should always be tested in line with paragraph 5 above, using the
worst case scenario challenge load in use by any healthcare waste producer.
On site Treatment Facilities
10. Treatment facilities located on, and serving only, the premises of production of
the waste have three options, either
 Option 1; Test for the general worst case scenario challenge load, as indicated in
paragraph 9 above for Off-site treatment facilities. This option is the Environment
Agency’s recommended option, OR
 Option 2; Test as indicated in paragraph 5 above, using the worst case scenario
item generated by that premises of production. If this option is chosen the licence
holder must demonstrate that they have sufficient knowledge, control and
monitoring of waste production and on-site purchasing such that the producer of
the waste would not be able to introduce a more challenging item into the waste
without their knowledge. This might for example be more applicable for devices
intended to operate within specialist units. OR
 Option 3; Segregation of difficult to treat items. In that case the device must be
tested on the basis of the remaining worst case scenario challenge load identified
from waste composition analysis. If this option is chosen the licence holder must
demonstrate that they have sufficient knowledge, control and audit monitoring of
waste segregation such that the producer of the waste would not be able to
introduce a more challenging item into the waste without their knowledge.
Whichever option is chosen the device must routinely operate on the worst case
scenario load cycle selected and validated.
37 of 48
DRAFT FOR COMMENT
Appendix B : Routine Efficacy Monitoring
All clinical waste treatment devices should be monitored routinely throughout their
operational life to ensure that microbial inactivation is occurring and that performance
is maintained.
The following is considered to be the minimum requirements for such monitoring.
B1: For those plants for which the use of spore strips is appropriate
1. The minimum frequency of monitoring is specified in Table B1
2. For thermal processes, thermal indicator strips or multipoint data loggers should
always be used in parallel where possible.
3. Either qualitative or quantitative enumeration of spore strips with a certified
population may be used.
4. Controls and certificates from the test batch should also accompany each set of
samples.
5. The quantitative criteria for success are as follows
 95 % of the individual spores strips, with a population of >1 x 106, in the first
6 months of operation , and each calendar year, should demonstrate 4 log10
inactivation or higher
 For thermal processes thermal indicator strips should accompany each spore
strip and indicate that the minimum time and temperatures have been
achieved for 99% of spore strips.
 The number and type of spore/thermal indicator strips used, and the
frequency of spore testing throughout the calendar year is uniform.
 For each calendar year a summary report should be prepared that indicates
the results obtained and any failures. The data should be referenced to the
validation report to demonstrate that predicted treatment efficacy, rather than
minimum standards, are being achieved. 90% of spore results should
demonstrate a level of inactivation  the 95% confidence level of treatment
determined during validation.
6. The qualitative criteria for success are as follows
 95 % of the individual spores strips, with a population of >1 x 104, in the first 6
months of operation, and each calendar year, should demonstrate no growth.
 For thermal processes thermal indicator strips should accompany each spore
strip and indicate that the minimum time and temperatures have been
achieved for 99% of spore strips.
 The number and type of spore/thermal indicator strips used, and the
frequency of spore testing throughout the calendar year is uniform.
 For each calendar year a summary report should be prepared that indicates
the results obtained and any failures.
 Where >5% (or 1, whichever is greater) of spore strips exhibit growth in any
calendar year quantitative testing should be used in future instead of
qualitative testing.
38 of 48
DRAFT FOR COMMENT
7. These criteria must include the requirement for all test strips to be valid. The
percentage allowance has been provided to allow for both potential
contamination and the uncertainty of microbial data.
8. If at any time during the calendar year it becomes clear that these criteria cannot
be met for that year, the Regulator should be informed immediately, and the plant
should cease operations until such time as the cause can be identified and
remedied to the satisfaction of the Regulators. In order to recommence
operations additional validation is required (see Appendix A.)
9. In any other circumstances, where the licence holder becomes aware that one or
more batches of waste may not have been treated to the required standard, the
Licence holder is expected to take appropriate action.
Table B1
Routine Monitoring of Microbial Inactivation where the use of spore
strips is appropriate
Continuous
Test
Test
Minimum
Number of
Hourly
frequency
frequency
Number spore Control
throughput or (first
6 (operational,
strips or sub- strips
batch
cycle months
of after the first samples
load.(kg)
operation)
6 months)
0-50kg
Monthly
quarterly
5
1
51-500 kg
Fortnightly
Bi-monthly
5
1
501-1000kg
Weekly
monthly
5
1
B2 : For those plants for which suspension testing is required.
1. The minimum frequency of monitoring is specified in Table B2
2. For thermal processes, thermal indicator strips or multipoint data loggers should
be used in parallel where possible.
3. Quantitative enumeration of spore suspensions with a certified population is
required.
4. A single control run is required.
5. The number of test runs and sub-samples per test run is indicated in Table
B2.
6. In other respects:
 the procedures in section B1
 the quantitative criteria for success from B1
Note : The Environment Agency accepts that Site Commissioning Validation may use
both spore suspensions, and spore strips fixed within the main body of the waste,
solely for the purpose to demonstrating that spore strips can be used for routine
monitoring. This requires a demonstration that statistically the same results are
achieved by either method. This does not extend to the placement of spore strips in
any other location, for example in sampling ports.
39 of 48
DRAFT FOR COMMENT
Table B2 : Routine Monitoring of Microbial Inactivation Where Suspension testing is
required
Continuous Hourly Test frequency
Test frequency
Number of Number
throughput
or (first 6 months (operational,
samples
test runs
batch
cycle of operation)
after the first 6 subload.(kg)
months)
samples per
test run
0-250kg
6 monthly
Annually
3
1
251-750 kg
6 monthly
Annually
6
2
751+kg
Quarterly
6 monthly
6
3
40 of 48
of
DRAFT FOR COMMENT
Appendix C : Emissions Monitoring & Benchmarks
It should be recognised that emissions from technically sound clinical waste
treatment plants, operated under good practice with appropriate containment, and
treating appropriate waste should be low.
Where waste acceptance or pre-acceptance procedures are poor, and/or
containment is inadequate or unproven, this assumption cannot be made. The onus
is therefore on the licence holder to demonstrate that emissions from the plant are
controlled during both site commissioning and more importantly during routine
operation.
Potential emissions include




Microbes, particularly in the form of bioaerosols
Chemicals, particularly volatile organic carbons. Formaldehyde is of particular
concern.
Pharmaceuticals, as a source of complex chemical emissions.
Microwaves, from containment failures of microwave technologies.
Examples of most of the above have previously been identified as significant issues
on clinical waste treatment sites.
The purpose of this section is to ensure that monitoring is in place to identify failures
in the design, integrity, containment or operation of the site or process.
Reference should be made to Agency Guidance M17 Monitoring of particulate matter
in ambient air around waste facilities.
1: Microbial Emissions Monitoring.
Microbial monitoring is required, as there is the potential for aerosols containing
pathogenic organisms to be released during the operation of alternative waste
treatment plants. Potential sources include:

During maceration of untreated clinical waste

The release of exhaust gases.

During maceration of treated clinical waste.

Failures in plant integrity
One of the problems associated with such monitoring is the variation of types and
number of microbes within the load. Determining which ones to monitor for, and the
quantitative relevance of any detected, is difficult to ascertain. Several may also arise
from other sources and therefore be unrelated to plant emissions. The following
procedure using tracer spore suspensions is recommended. However it should be
noted that monitoring of other indicators may be undertaken as an alternative to
tracer spore suspension where demonstrated by the licence holder to be appropriate.
The procedures for such monitoring should be agreed with the Regulator prior to
implementation.
41 of 48
DRAFT FOR COMMENT
Procedure for Microbial Emissions Monitoring using tracer spore suspension.
For technologies that shred or macerate the waste prior to treatment
1. A dry or liquid suspension of bacillus spores should be prepared and dispensed
(in a laboratory environment) in a number of sealed, small volume plastic
containers. These should be dispersed throughout the waste load and processed.
For other technologies
2. Dry or liquid suspensions of bacillus spores should be prepared and dispensed
(in a laboratory environment) both loosely in waste inside containers (bags,
boxes etc), and inside worst case challenge load containers (suction
canisters/chest drains). These should be dispersed throughout the waste load
and processed.
3. Spore strips should never be used for bioaerosol emissions monitoring.
4. The quantity of spores should equate to a minimum of 1 x 106 spores per gram of
total waste load.
5. All devices should be tested, during commissioning validation, during the first six
months of operation and periodically thereafter as indicated in Table A6-2.10.4
6. Process emission monitoring should continue throughout the operational life of
the plant.
Frequency of Testing
7. The minimum frequency of monitoring is specified in Table C1
Sampling Methodology
8. The sampling should consist of air monitoring and surface monitoring
9. The number of samples and location of sampling points will depend on the nature
of the process and size of the device. Recommended sample locations are
specified under the respective headings of Air Monitoring, Surface Monitoring and
Wastewater Discharge Monitoring.
10. The sampling programme should be designed to take sufficient samples to
enable the results to be quantitatively related to the input dose.
11. Samples should be taken:
- prior to the processing of the seeded waste (controls),
- at intervals during the processing of the seeded waste (the intervals should
relate to process stages and timing of potential emissions), and
- periodically thereafter for at least 2 hours after the cycle is complete
12. The aim of the monitoring programme is to produce a quantitative ‘estimate’ of
the total number of tracer organisms emitted from the device relative to the input
dose by each route.
Air Monitoring
13. Air monitoring should be conducted around identified point source emissions from
the process, as well as at the site boundaries, and at any other relevant locations
within the site – for example open vehicle access doors to building within which
the plant is located.
42 of 48
DRAFT FOR COMMENT
14. Key examples of emission sources:Point Source Emissions
The main point source emission to air is from the venting of exhaust gases.
Exhaust gases should always be treated (e.g. filtered through a HEPA filter).
Monitoring is required to demonstrate that the treatment of the gases has been
effective and should take place at each emission point
Sources of fugitive Emissions include:
i) Maceration of untreated clinical waste. This is potentially the most
significant source of pathogenic bioaerosols. Monitoring should
demonstrate that containment measures in place are effective.
ii) Maceration of treated clinical waste may also result in the generation of
bioaerosols as treatment is required to reduce the number of microorganisms rather than eliminate them. This monitoring should demonstrate
if additional containment measures are required.
iii) Maintenance or access ports. Monitoring is necessary to ensure that these
do not compromise the integrity of the plant, that they are effectively sealed
during operation, and that emissions are not released.
15. It is recommended that active (centrifugal/vacuum) impaction onto agar using
Anderson or slit samplers, or equivalent, is used to sample for bioaerosols. Data
submissions should contain information indicating the recovery efficiency of the
method used.
16. Monitoring should be conducted throughout the emissions monitoring exercise,
and with individual sample times to coincide with steps in the process where
emissions may occur (for example the passage of seeded waste through a
shredder).
Surface Monitoring
17. To support the air monitoring outlined above, it is recommended that settle plates
are employed in large numbers to form a grid-like pattern around the device/site.
18. The exposure time for each plate, and replacement frequency during testing may
need to consider contaminants and total microbial load.
19. The use of a regular exposure time, a series of plates at each sampling point,
and a grid placement should enable an estimation/calculation of the total number
of organisms that have settled during the monitoring period for
 Each grid square, and
 For the whole site.
This can be compared to the input dose to provide a quantitative release estimate
for the process.
Wastewater Discharge Monitoring
20. Where the process produces a wastewater this should also be monitoring at
intervals during the testing. For chemical processes, the potential need for
neutralisation of disinfectant should be considered.
21. The purpose of this additional monitoring is to ensure that both the
 Treatment process is operating effectively; and
43 of 48
DRAFT FOR COMMENT
 The wastewater arises post treatment
22. Wastewater should be sampled prior to entering the drainage system, and as
near to the point of origin as possible.
Table C1 - Process Bioaerosol Emissions Monitoring
When a suspension of Bacillus Spores has been used
First 6
Subsequently Minimum
months
(if proven and Number of
agreed)
Sampling
points
For devices
which
shred/macerate
untreated waste
For other devices
Quarterly
Annually
See text
Minimum
Number of
samples per
sampling
point
See text
6-monthly
Bi-annually
See text
See text
2 : Chemical Emissions Monitoring
Waste acceptance and pre-acceptance procedures are intended to prevent waste
containing chemicals entering the treatment process. There are two primary
consequences where these procedures are insufficient :

volatile chemicals are released to atmosphere/water . This is a particular
concern with thermal processes.
Incompatible reactions occur. This is a potential concern with chemical
treatment processes.
During validation, a written assessment of the Volatile Organic Compounds (VOCs)
emitted from the process shall be submitted to the Agency. The written assessment
shall include:





a scale drawing showing location of the emission points monitored;
sampling of the emission and comparison against the benchmark values listed in
Section 3.11 of the Sector Guidance Note IPPC S5.06, dated December 2004, to
assess their significance;
proposal of any necessary modelling of the emission; and
details of how any emissions are to be prevented during the operation of the
facility.
particular attention should be paid to VOC’s that are associated with the
healthcare waste stream (for example Formaldehyde)
VOC monitoring should take place during commissioning, after the first 6 months of
operation, and annually thereafter.
Thermal process (e.g. autoclaves) that employ water condensers should monitor
liquid discharges for VOC’s.
For chemical processes consideration should be given to possible emissions from
the chemical agent used, and any products known to arise from its reaction with the
waste.
44 of 48
DRAFT FOR COMMENT
3 Pharmaceuticals emissions monitoring
Waste acceptance and pre-acceptance procedures are intended to prevent waste
containing pharmaceuticals, including fully discharged medicinally contaminated
syringes, entering the treatment process. Monitoring of emissions from such
substances would not normally be required where the licence holder can
demonstrate that waste acceptance and pre-acceptance procedures are sufficient to
exclude such waste.
4: Microwaves emissions monitoring
Licence holders of microwave facilities should be aware that failures in containment
might result in leakage of non-ionising radiation and have operational procedures to
check for such leakage at regular intervals.
5 : Criteria for Success
The licence holder should monitor and react to changes, trends and patterns in
emissions. For example a gradually increasing trend around the site may require
improvements in site procedures generally, whilst a sudden increase of emissions
around the shredder may indicate a failure of a specific containment feature.
Emission Benchmarks
6: Emission benchmarks
Table C2 details emission benchmarks for point source emissions from the clinical
waste site. These best practice benchmarks are not mandatory release limits.
Table C2 : Emission Benchmarks
Emission
Air – sample points <10m from the
treatment plant.
Water
Measure
Cfu
Unit
Bacillus
1000
Per cubic metre1
spores
Bacillus
(300)2
Per litre1
spores
Note 1 : These Units relate to the overall monitoring period so the cfu benchmark
applies to
 Each individual sample of air taken, with a calculation made to report the result
per cubic metre.
 For each individual settle plate (this is not an average)– a calculation made to
adjust for surface area of a settle plate and exposure time (for example if settle
plates are deployed for only 15 minutes of every hour then the result must be
multiplied by 4).
 Each individual sample of water taken, with a calculation made to report the
result per litre.
Note 2: These benchmarks are indicative only, and will be reviewed periodically.
Table C3 provides additional guidance with respect to fugitive emissions from the
site, these can be used to support the emission benchmarks in Table C
45 of 48
DRAFT
Table C3 : Emission of spiked organisms
Emission
Measure
Cfu
Unit
Air – sample points>10m from the Bacillus
300
Per cubic metre1
treatment plant
spores
Surface – sample point < 10m
Bacillus
(20000)2
Per square metre
from the treatment plant
spores
per hour 1
Surface – sample points > 10 m
Bacillus
(5000)2
Per square metre
from the treatment plant.
spores
per hour 1
Note 1 : These Units relate to the overall monitoring period so the cfu benchmark
applies to
 Each individual sample of air taken, with a calculation made to report the result
per cubic metre.
 For each individual settle plate (this is not an average)– a calculation made to
adjust for surface area of a settle plate and exposure time (for example if settle
plates are deployed for only 15 minutes of every hour then the result must be
multiplied by 4).
 Each individual sample of water taken, with a calculation made to report the
result per litre.
Note 2: These benchmarks are indicative only, and will be reviewed periodically.
46 of 48
DRAFT
Appendix D : Modern Regulation
Introduction
The treatment of clinical waste requires either a Waste Management License or a
Pollution Prevention and Control Permit.
The Environment Agency recognises that there are two specific circumstances where
is may not be proportionate, or in the public interest, to require a license or permit.
 Laboratory autoclaves, and
 Small clinical waste treatment devices on the premises of production
The Environment Agency must balance this with significant concerns over
 treatment efficacy,
 producer segregation, and
 the potential impact of this proposal on the marketplace
The following is proposed :
Proposed Position
The treatment of infectious waste on the premises of production of that waste in
accordance with the criteria identified in Appendix D of the Environment Agency
Technical guidance on Clinical Waste Management facilities are met.
Criteria
1 : Laboratory Autoclaves - The device (or devices)
 is situated on the laboratory premises of production of the waste
 the licence holder would be the waste producer if a licence were required.
 treats only infectious waste generated by that laboratory in containment level
1-3 facilities.
 The total quantity of infectious waste treated on the site by laboratory
autoclaves is less than 1 tonne per day.
 is validated in accordance with HTM 2010 or equivalent for the worst case
scenario challenge loaded generated by that laboratory to achieve a minimum
temperature of 121’C for a minimum time of 15 minutes within the core of that
challenge load. Equivalent to STAATT level IV using Geobacillus
stearothermophilus.
2 : Other Clinical Waste Treatment - The device (or devices)
 is situated on the premises of production of the waste
 the licence holder would be the waste producer if a licence were required.
 treats only infectious waste generated by that producer of the types indicated
as suitable in section 2.2, excluding those indicated as unsuitable in section
2.3.
 is supported by the waste acceptance audit procedures identified in section 3.
 The total capacity of the infectious waste treatment devices of any type on the
site, excluding laboratory autoclaves, is less than 200kg tonne per day.
 Has demonstrated efficacy in accordance with Section 5 and methodology
consistent with Appendix A, and the site commissioning validation report has
been agreed in writing with the Environment Agency. This report agreement is
47 of 48
DRAFT

valid for a period of 48 months from the date of agreement. Operations should
not commence until the report has been agreed. The site commissioning must
be repeated and resubmitted for agreement for a further 48 months.
Incorporates a shredding/maceration (or other equivalent destruction step) to
the standard specified in section 5.4 (recommended), or is disposed of as
offensive/hygiene waste with appropriate procedures at the receiving landfill.
The two options are provided separately in consideration of the different nature of the
waste they treat, established operational practices, the differential treatment
standards applied, and significant concerns with both waste segregation and device
validation with regard to the option 2.
1
References
APPENDIX 6 Sector Guidance Note IPPC S5.06 – Supplementary PPC for Clinical
Wastes
Safe Disposal of Clinical Waste, 1999, Health Services Advisory Committee, ISBN
07176 2492 7.
Safe Management of Healthcare Waste: A Public Consultation, Gateway No 5471,
Department of Health. www.dh.gov.uk.
Technical Guidance WM2, Hazardous Waste, Interpretation of the Definition and
Classification of Hazardous Waste, Environment Agency, ISBN 1 84432 4540.
Clinical Waste Disposal/Treatment Technologies (alternatives to incineration), Health
Technical Memorandum HTM 2075, NHS Estates, The Stationery Office, ISBN 0-11322159-2.
CONTROL OF AEROSOL (BIOLOGICAL AND NONBIOLOGICAL) AND CHEMICAL
EXPOSURES AND SAFETY HAZARDS IN MEDICAL WASTE TREATMENT
FACILITIES FINAL REPORT Contract No. 200-95-2960 RTI Project No. 93U-6449
Prepared For National Institute for Occupational Safety and Health, November 1997
Non-incineration Medical Waste Treatment technologies, Healthcare without harm,
August 2001, http://www.noharm.org/details.cfm?type=document&id=919
Non-incineration Medical Waste Treatment technologies in Europe,
without harm, June 2004,
http://www.noharm.org/europe/medicalwaste/nonincineration
Healthcare
Safe management of Wastes from Healthcare Activities. World health Organisation,
1999, http://www.healthcarewaste.org/en/documents.html?id=1
48 of 48