Environmental Permitting RegulationsSector Guidance Note

EPR S5.07 Clinical Waste

Bob McIntyreTechnical Advisor -Hazardous Waste

National Compliance and Technical Services

Background ?April 2008 the Environmental Permitting Regime replaces Waste

Management Licensing and PPC regimes.

We now have: A New Application Form A New Permit Template A Standard Rule for healthcare waste transfer station A Standard Rule for healthcare waste treatment and transfer. ‘Getting the Basics Right’ Guidance (EPR 1.00) Horizontal guidance (odour, noise etc)

and Previous sector guidance notes are under review

Clinical Waste EPR S5.07My task is to combine the PPC clinical waste guidance (April 2007), with the draft WML clinical waste guidance (Dec 2006),

And then to reformat and present in line with the new approach, Whilst making as few changes as possible. To create sector guidance note EPR S5.07 on clinical waste

Although many documents undergoing this exercise are unlikely to be consulted upon due to the minimalist nature of the changes

We anticipate that a number of waste sector guidance notes, including S5.07, will be updated as well, and

Are therefore likely to be consulted upon (July 2008?) This relevance of this may depend on the nature of any changes.

Why am I here ? Because

(i) you asked me to come along.

(ii) your verbal informal input and discussion at the authoring stage may be more useful than formal submission the consultation stage.

(iii) The guidance is not perfect, you have the practical experience, and we welcome your thoughts in improving it.

(iv) We’d like your ‘buy in’ and support.

Therefore I am not really here to debate or defend their existing content, as the existing principles are expected to be carried forward.

However this exercise does allow for aspects to be clarified, corrected, updated, made less of a burden etc.

So I’m here to offer you the opportunity to discuss certain aspects whilst it is being written.

If you have a better solution now is the time to say so.

Key Issues ?The document contains the following issues that may be useful to discuss. Contingency planning / maintenance (section 1.1 of EPR S5.07) Recycling (section 1.5 of EPR S5.07) Permitted wastes (Section 2.1) Waste pre-acceptance and acceptance (Section 2.2) Treatment validation (Section 2.3 and Appendix A) Waste handling and storage (fugitive emissions) (Section 3.2) Emissions monitoring (Section 3.3, Appendix B and C )

Anything I have missed ?

The intention is to work through these one at a time, discussing each in turn.

Contingency planning/maintenanceEPR 1.00

‘You should have contingency plans that ensure a minimum impact on the environment in the case of breakdown, accident, enforced shutdown etc’

‘Poor maintenance is a common cause of environmental incidents.

Where the failure of equipment or infrastructure..could increase emissions to the environment, you must:

Carry out a programme of planned preventative maintenance , rather than waiting for equipment to fail

Follow the inspection and maintenance schedules that the manufacturer recommends, or write down your justification for following nay other schedule.’

‘Even when ‘incidents and non-conformances’ occur, you are responsible for the environmental performance of the installation and for achieving compliance with the permit…..you should be able to cope with abnormal operation and return the activity to normal operation.

Contingency planning/maintenance etc.There have been a more than a few clinical waste issues relating to breakdowns. failure to hold spares, leading to prolonged down time. Inadequate maintenance programmes Insufficient maintenance/engineering expertise. Methods of clearing jammed shredders. Accepting waste without having a defined disposal outlet Leading to ‘excess’, prolonged and inappropriate storage. Feedback problems through the waste chain

Therefore additional measures for contingency planning and maintenance are likely.

What do you think is good practice and reasonable ?

Recycling Avoidance, recovery and disposal of wastes produced by the activities

For the following activities referenced in schedule 1, table S1.1 (A1 to A4 etc.)The operator shall: (a) take appropriate measures to ensure that waste produced by the

activities is avoided or reduced, or where waste is produced it is recovered wherever practicable or otherwise disposed of in a manner which minimises its impact on the environment;

(b) review and record at least every 4 years whether changes to those measures should be made; and

(c) take any further appropriate measures identified by a review.

(Taken from permit template for IPPC Directive Activities)

Recycling‘How to Comply (EPR 1.00)

If you propose any disposal explain why recovery is technically and economically impossible, and; describe the measures planned to avoid or reduce any impact on the

environment.’

Questions :

(1) Is recovery of clinical waste technically and economically impossible ?

(2) If the answer is ‘no’, what do we do ?

Permitted Wastes (Treatment)The permit application form refers to a table in the new guidance

(S5.07). This table will be expected to closely match the published standard rule.

The table excludes waste packaged/transported in a manner inconsistent with the requirements for Carriage.

The table permits the disinfection of infectious waste classified as: 18 01 03* 18 02 02* 20 01 99

Permitted Wastes (Treatment ) the following wastes are then specifically excluded from waste treatment

activities: (i) : Any waste containing waste medicines and chemicals, waste

contaminated with cytotoxic and cytostatic medicines, anatomical waste (identifiable human or animal tissue arising from healthcare), or Dental amalgam;

(ii) : Sharps boxes containing any of the excluded wastes from (i) and (iii) or Sharps that are contaminated with pharmaceuticals in any quantity (including syringes that are fully discharged, partially discharged or undischarged).

(iii) : Biohazard waste : Any waste known or likely to contain ACDP Hazard Group 4 biological agents; Any waste from a containment level 3 laboratory: and All Microbiological cultures from any source, and, any potentially infected waste from pathology departments and other clinical or research laboratories (Unless autoclaved before leaving the site of production).

Permitted Wastes (Treatment)Additional wastes can in principle be added however

these will have to go through a justification process.

Potential issues Sharps Biohazard Waste Non-hazardous healthcare and related wastes

Discussion ?

Shredding ?The standard rule mirrors S5.06 Appendix 6 (PPC).

‘Shredding/maceration

Treatment shall be capable of reducing the waste to a particle size of less than or equal to 50mm and no particle shall exceed 80mm in any dimension ‘

Questions: Is shredding of clinical waste necessary ? If so, why is it necessary ? If so, what standard is reasonable and achievable ?

Waste pre-acceptance and acceptance Waste pre-acceptance and acceptance procedures are

already included in the permit application form, and in the standard rules.

After representation from yourselves it is our intention to apply them uniformly across the sector

Treatment Transfer Incineration

Pre-acceptance stageArises from hazardous waste pre-acceptance and acceptance

criteria, based on regular chemical analysis to confirm nature of the waste prior to collection fro each producer.

Adapted for clinical waste to require detailed information arising from an annual audit of each producer to determine waste segregation practice and waste composition, rather than analysis..

Already in clinical waste treatment PPC permits.

Pre-acceptance issues- Who is responsible ?- Intermediary waste company (transfer station)- Domestic collections by local authorities- Waste produced in households by PCT’s, ambulances etc.- Drug litter, tattoo parlours, body piercing.- HTM 07 01 Safe Management of Healthcare Waste- Any others ?

Implementation timescale- Large producers ?- Small producers ?- High risk producer groups ?- Higher risk sites and operators ?- Frequency ?

Waste AcceptanceProcedures to assess wastes on arrival Duty of Care and Carriage requirements. Inspection of loads – wheeled carts Labelling and identification of wastes by producer

(rather than holder) (carriage in bulk) Site inventory requirements ‘age’ of waste (odour management plan – duration of

storage)

Treatment validation (microbial) Given the recent history it is probably fair to say that this is an issue

that is of declining priority. The focus should be on testing well, Rather than testing lots.

We are proposing to make a 40-60% reduction in the requirements for microbial

validation. (60% for the larger plants) Add additional guidance to clarify some questions that have

arisen since the issue came to the fore in 2004., e.g. Validation of chemical treatment processes.

Treatment validation (other)We’ve add several discussions with regard to the treatment of

medicinally contaminated waste, using novel technologies, with elements of the pharmaceutical sector.

We’ve also had some discussions on non-incineration technologies for anatomical waste

The issue of standards and validation arose from these discussions We are likely to set out indicative appropriate measures for

validation, These will require testing of plant after issue of the permit Typically with a pre-operational condition Requiring demonstration of what the process achieves.

Waste handling and storage (fugitive emissions) ‘All permitted waste shall either be stored: (Standard Rule) - within a building provided with an impermeable surface with sealed drainage system; or - within sealed containers located on an impermeable surface with sealed drainage system. Sealed containers shall be kept locked when not being loaded or unloaded. All waste treatment activities shall take place within a building

provided with an impermeable pavement and sealed drainage system.

Compaction shall be limited to treated wastes. Wastes which arrive in bags or other non-rigid containers shall be

transferred into rigid containers immediately. Rigid containers for the storage of waste shall be of a design that: - will prevent the escape of any liquid; - has a lockable lid or other means of securing the container.’

Waste handling and storage Waste containing or contaminated with cytotoxic and cytostatic

medicines shall be kept separate from other wastes. Waste medicines, dental amalgam, medicinally contaminated sharps

(including fully discharged syringes) and non-medicinally contaminated sharps shall be kept separate from each other and other wastes and stored in a secure place.

Body parts and organs shall be stored in designated refrigerated units within a building.

The transfer of waste from vehicles or containers into other vehicles or containers shall only take place on areas with an impermeable surface with sealed drainage system.

Waste dispatched from the site shall be packaged in accordance with, and loaded onto vehicles that meet, the appropriate requirements for the carriage of dangerous goods.

Washing and disinfection of mobile containers shall take place on areas of impermeable surface with sealed drainage system.

Emissions monitoring (microbial)Microbial: Current procedures are based on seeding waste with high dose

of tracer spores, then Both air sampling and surface sampling (settle plates) proving far more useful than we had perhaps anticipated. showing clear daylight between some sites and others. Appear to have dose/sensitivity about right. Intend to fine tune it slightly to clarify some technical aspects. Should not be a substantive change in procedures. Although we have indicative benchmarks, we do not have

enough information yet to review them.

Emissions Monitoring (Chemical)This is likely to be a key issue for the immediate future. Producer audits are regularly finding both ‘laboratory smalls’ and

formaldehyde preserved tissues in clinical waste from the laboratory areas of acute hospitals.

Pharmaceuticals are a concern with some producers. The Veterinary sector is probably the worst of the small producer groups,

and it is likely that the vast majority of veterinary clinical waste is ‘incineration only’.

The veterinary sector and those handling and disposing of their waste (and their documents) has been identified as a major issue for the forthcoming year or two.

Our preference is to view waste pre-acceptance/acceptance as the primary control measure to exclude such waste.

However we are likely to be asked by some of our site inspectors to increase the focus and measures associated by this issue.

What Happens Next The 1st draft of the document is likely to be circulated within the

Agency before the end of June. This is likely to be issued for consultation at the end of July or

early August. You can respond formally to the consultation.

In theory, if you are able to nominate a small group of representatives, we may be able to either

include them in the circulation of the first draft, or Meet and go through it line by line. This may be more useful ? Although time to do this may be constrained.

THE END