To:
Terry Murphy
Pamela Chapman
Andy Collingwood
Stuart Denham
Alan Kenny
Mike Taylor
From: Lorraine Brayford
Date: 2 December 2003
Copies: Darryn Kerr
Brian Latham
File Ref: OME 8 & OME 61
INFORMATION NOTIFICATION
(1)
Prescription Only Medicine (POMs) Contaminated Sharps
(2)
Waste Incinerator Directives (W.I.D.) – 2000/76/EC
England & Wales
(1) Prescription Only Medicine (POMs) Contaminated Sharps
This note is to remind the NHS about the Regulatory Status associated with
the disposal of Prescription Only Medicine (POMs) contaminated sharps.
ACTION
It is essential that this note and the attached Environment Agency letter of 27
October 2003, be brought to the attention of your Strategic Health Authority
colleagues, and through them, the NHS.
The Environment Agency have undertaken a survey of sharps boxes and their
contents and are concerned that the NHS are not acting responsibly or within
the letter of the legislation in how it disposes of sharps contaminated by POMs.
Any sharps contaminated by POMs, irrespective of the amount MUST be
treated/disposed of as Special Waste and not clinical waste. Please note a
residual coating of POM is still contamination. There is no minimum threshold
concentration of POMs, they are always special waste.
The Environment Agency letter of 27 October 2003 attached at Appendix A
explains the situation.
TIMESCALE
This is urgent.
NHS Trusts who do not comply with the Environmental
Protection Act 1990 section 34 ‘duty of care’ requirements could face fines or
prosecution.
FURTHER INFORMATION
NHS Trusts who require further information should contact their local
Environment Agency office in the first instance.
(2)
Waste Incinerator Directives (W.I.D.) – 2000/76/EC England
& Wales
Info note
This note is to inform you about the W.I.D and how its implementation could
affect the NHS and its ability to properly dispose of clinical/special/hazardous
waste.
The attached letter and background note at Appendix B provides the relevant
details.
Action
It would be appreciated if you could ensure this note is brought to the
attention of your Strategic Health Authority colleagues and through them
circulated to all NHS Trusts.
The attached Information Note and Background paper will also be posted on
the Agency website www.nhsestates.gov.uk under Sustainable Development on
the waste page.
Timing
The WID applies to new plants from 28 December 2002 and to existing
plants from 28 December 2005. Applications for a new permit or a variation
of the existing permit or authorisation to include WID conditions must be
made to the Regulator in the period 1 January 2005 to 31 March 2005.
The NHS needs to be sure that their waste contractors will be seeking to
comply with the WID requirements and applying for new permits to operate
from the Regulator.
Further Information
NHS trusts that require clarification specific to WID should contact their local
Environment Agency office in the first instance.
GENERAL
If there are any general enquiries about these Information Notes please do not
hesitate to contact me at lorraine.brayford@doh.gsi.gov.uk
Kind regards
Lorraine Brayford
 0113 2547040
APPENDIX A
ENVIRONMENT AGENCY
Our ref :
RDM1003(Sharps)
Date :
27th October 2003
For Attn Of:
Brian Latham
NHS Estates
Dear Brian,
Prescription Only Medicine Contaminated Sharps
As discussed, the Environment Agency is shortly to be producing an internal communication that will
highlight issues of concern with regard to clinical waste. One of the key issues is likely to be the status
of the rigid containers referred to as ‘sharps boxes’.
A brief outline of the Regulatory Status of Prescription Only Medicine contaminated
sharps is detailed below.
I would be grateful if you would disseminate this information to the NHS Trusts to ensure that they are
aware of their regulatory obligations.
Status of Sharps Waste
The position with regards to Sharps Waste contaminated with Prescription Only
Medicines is as follows :The Special Waste Regulations 1996 (as amended) apply to controlled waste (CWR).
Regulation 2(2)b indicates that controlled waste (including clinical waste), other than
household waste, which is, or contains, a prescription only medicine (POM) is special
waste. Where sharps are contaminated with POMs they are always special waste.
There is no minimum threshold concentration for POMs below which renders them
‘not special’.
In undertaking its regulatory duties the Agency has to act proportionately and
therefore the Environment Agency does not normally take enforcement action for
failure to consign such waste, which is special waste, as long as it meets three
conditions:(i)
The waste consists of fully discharged syringes.
(Where partially discharged syringes and ampoules, tablets, or any other form of
POM is present then this enforcement position does not apply)
(ii)
The waste is disposed of at a suitably authorised facility.
(This ‘suitable authorisation’ relates to a facility authorised to dispose/treat wastes
described both as sharps AND as special waste)
(iii)
The waste is managed in accordance with Health and Safety Guidance “Safe
Disposal of Clinical Waste”
Description of the Waste
Concerns have been raised about the common presence of clinical waste, which does
not constitute ‘sharps’, in the rigid containers. These concerns are supported by a
survey of ‘sharps box’ contents.
The waste producer has a Duty of Care (Section 34 of Environmental Protection Act
1990) to provide a description of the waste that enables subsequent holders to avoid
mismanaging the waste.
The rigid container must be described on the basis of its contents, and not on the basis
of the container type.
For example: where waste pharmaceuticals (which are not sharps) are also placed in
the rigid container, the description of the waste should include the fact that the waste
is mixed sharps and pharmaceutical waste (as opposed to POM contaminated sharps).
Status of Treatment Processes
The introduction of low temperature, or other alternative technologies, for the
treatment of clinical waste has resulted in a number of such facilities accepting POM
contaminated sharps material.
Where an existing plant has an authorisation to accept POM contaminated sharps as
special waste it may continue to do so. This does not extend to mixed sharps and
pharmaceutical waste.
Applications for new facilities will be given due consideration and, dependent on a
variety of site specific factors including a risk assessment of the wastes, may be
authorised to accept such waste.
In both cases, where the plant is not technically capable of effectively treating POMs
then they will be present in the outflow material, however dilute. Where a waste
outflow material contains a POM it is special waste. There is no specific enforcement
policy that would enable non-consignment of this material.
It is currently the Environment Agency’s view that sharps frequently contain
prescription only medicines (POMs) and are therefore considered to be special waste.
It is considered that many low temperature heat, and perhaps chemical, treatment
processes are unlikely to destroy POMs. In these circumstances residues will be
considered special waste. High temperature processes may however be effective in
destroying the POMs and in these circumstances the residues may not be special
waste.
Recommendations for NHS Trusts

They should identify POM contaminated sharps as special waste to assist the waste contractor in
disposing of them appropriately.

They should identify the rigid container as mixed sharps and pharmaceutical waste where
segregation practice results in the placement of ‘non-sharp’ pharmaceutical waste in the sharps bin.

The waste should be consigned where the enforcement position does not apply.

They should ensure that the waste contractor is disposing of this waste at a suitably authorised
facility.
With regard to the latter point, it is likely that a range of authorisations with regard to sharps disposal
are in existence. The NHS Trust may find the following points useful to consider:

Is the treatment plant authorised to accept Sharps/Group B clinical waste?

Does this authorisation specifically authorise the acceptance and treatment of special waste (POM
contaminated sharps)?

Is the treated waste from the plant being consigned as special waste?

For a rigid container of mixed sharps and pharmaceuticals a treatment plant would, in addition,
require and authorisation to treat Group D or pharmaceutical waste. This is unlikely to be the case.
The Safe Disposal of Clinical waste indicates that pharmaceutical waste should be disposed of at a
clinical waste incinerator.

If in any doubt, please contact the Environment Agency Area Office that regulates the treatment
plant in question.
If I can be of any further assistance please do not hesitate to contact me on the number
below.
Your Sincerely
Bob McIntyre
Technical Advisor – Hazardous Waste Process
Tel 01392 352389
APPENDIX B
Information note to all NHS Trusts in England
28 November 2003
WASTE INCINERATOR DIRECTIVES 2000/76/EC – WID
ENGLAND & WALES
ISSUE
This note is to inform you about the Waste Incinerator Directives (WID) and
how its implementation could affect the NHS and its ability to properly dispose
of clinical/special/hazardous waste. The attached Background note and Defra
guide “Directive 2000/76/EC on the incineration of waste” provides further
detail.
Existing waste incineration plant will need to comply with the requirements of
WID by 28 December 2005 and will also require new permits to operate.
Action is required for the NHS to ensure it can continue to dispose of waste
that requires incineration post 2005.
NHS Trusts who fail to ensure their waste is properly disposed of face the
possibility of action being taken (prosecution or fines) by the regulator
(Environment Agency or Local Authority).
ACTION
Please check with your Waste Contractor:
1.
that they will be seeking to comply with the WID requirements;
2.
will be applying for new permits to operate from the Regulator;
3.
what contingency plans are in place should the permit not be obtained
for whatever reason; also
4.
check the terms of contract – be sure of your own position.
FURTHER INFORMATION
If you have any queries regarding the WID please contact your local
Environment Agency area office in the first instance.
General enquiries please do not hesitate to contact Lorraine Brayford at NHS
Estates on lorraine.brayford@doh.gsi.gov.uk
WASTE INCINERATOR DIRECTIVES 2000/76/EC – WID
ENGLAND & WALES
BACKGROUND NOTE
WHAT IS THE WID?
The Directive applies to incineration and co-incineration plant that burns municipal
waste; clinical waste; hazardous waste; general waste; and waste derived fuels.
The WID technical requirements aim to reduce pollution and set out operating
conditions; emission limit values to air and water; and any derogations that will be
available.
For new incinerator plant the requirements take immediate effect. For
“existing waste incinerator installations” there is a transitional period for the
phasing in of the WID by the end of 2005.
Guidance on WID is available on the DEFRA website at
www.defra.gov.uk/environment/ppc/wasteincin/index.htm
HOW DOES THIS AFFECT YOU?
If you contract with a Waste Contractor for disposal of healthcare waste you
will need to be assured that the contractor is able to continue to provide the
necessary incineration service post 2005. If that service is not guaranteed,
you will need to review your contract conditions and consider what alternative
arrangements may be required.
WHERE TO GO FOR FURTHER INFORMATION AND GUIDANCE
For more definitive information, you should consult:
 The WID Regulations (SI 2002 No. 2980 – The Waste Incineration
(England & Wales) Regulations 2002 – ISBN 0-11-044174-5)
 Defra Guidance on Directive 2000/76/EC on the incineration of waste –
www.defra.gov.uk

The Regulators: Environment Agency or Local Authority.