Standard Rules Consultation no 23: proposals for healthcare waste permits

Closed 10 May 2021

Opened 29 Mar 2021

Results updated 1 Dec 2021

Introduction

In July 2020, we published updated guidance for healthcare waste - Healthcare Waste: Appropriate measures for permitted facilities. This guidance replaced the existing guidance EPR: 5.07 Clinical Waste.

The existing standard rules permit for healthcare waste SR 2008 No:24: 75Kte clinical waste and healthcare waste transfer station, needs to be updated to ensure it provides an appropriate level of environmental protection and refers to appropriate measures and standards set out in the revised guidance.

We consulted you about withdrawing 2 further existing standard rules sets:

  • SR 2008 No. 25: 75Kte clinical waste and healthcare waste treatment and transfer station, of which there are currently only 2 permits in place

SR 2013 No.1: treat 100 tonnes a year of clinical and healthcare waste, as there are no issued permits under this rule set.

How we ran the consultation

We ran a formal consultation on our Citizen Space platform and Gov.uk for 6 weeks from 29 March 2021 to 12 May 2021.

We asked 10 questions relating to specific aspects of the standard rules detailed in the introduction:

  • Q1 to Q3 asked specific questions on the proposals for varying SR2008 No 24
  • Q6 and Q7 asked for views on the proposal to revoke SR2008 No 25 and SR2013 No 1
  • Q8 asked for views on the revised generic risk assessment
  • Q9 and Q10 asked for views on how businesses would be impacted and for any other comments

We received 10 responses to the questions. However, not all responses provided an answer to all the questions asked.

Of the 10 responses, 5 were from operators of healthcare waste management facilities or proposed healthcare waste management facilities. We also received:

  • 2 responses from trade associations
  • 1 response from a healthcare business
  • 1 response from a consultancy
  • 1 response from a local authority

We received 2 of the 10 responses by email which we manually uploaded to our Citizen Space platform.

Summary of key findings and actions we will take

Following consideration of your responses, we will amend SR2008 No 24 and the associated generic risk assessment in line with the proposals in the consultation including:

  • reducing the maximum quantities of waste to 5,000 tonnes a year
  • limiting the maximum quantity of non-hazardous waste stored on site to 20 tonnes at any one time
  • storing aerosol canisters with rules limiting how long they can be stored on site
  • meeting the requirements of the updated guidance ‘healthcare waste: appropriate measures at permitted facilities’

We will withdraw the SR2008 No 25 rule set with immediate effect for new entrants based on the responses received. The 2 current operators of the standard rules set can continue to follow them until we issue them with a bespoke permit.

For SR2013 No 1, we considered your responses and available options and still intend to withdraw the rules set with immediate effect. However, where appropriate, we will work with industry including innovative technology providers and our National Permitting Service to support applications for low risk, low volume healthcare waste treatment activities that promote the recovery of waste. For example, by clarifying the potential for abatement of permit application fees. We will consider developing a new standard rules permit for the specific treatment of healthcare waste in the future, if there is evidence of need. We will also consider issuing a regulatory position statement while we develop it if required.

Next steps

Following our consultation, we propose to amend SR2008 No 24 and the associated generic risk assessment in line with the proposals detailed in this response document. The updated rules set will apply for new entrants with immediate effect once published. Existing permit holders will have 3 months from the date the updated rules set is published to comply. We will send a letter to all existing permit holders providing them with the required information.

We will withdraw SR2008 No 25 with immediate effect for new entrants. Existing permit holders will be required to apply for a bespoke permit.

We will withdraw SR2013 No 1 with immediate effect.

Individuals who wish to follow up their responses, or points made within this document, in more detail are welcome to contact us at wastetreatment@environment-agency.gov.uk.

Please click here to view a summary of the responses. 

Links:

Overview

The Environmental Permitting (England and Wales) Regulations 2016 (EPR) allow us to make standard rule environmental permits to reduce the administrative burden on business while maintaining environmental standards.

We are consulting you about a revision to the existing standard rules (SR) permit for healthcare waste SR 2008 No:24: 75Kte clinical waste and healthcare waste transfer station. This is to ensure it provides an appropriate level of environmental protection and refers to the updated appropriate measures and standards set out in revised guidance.

Our proposed changes include the withdrawal of 2 further existing standard rules sets: SR 2008 No. 25: 75Kte clinical waste and healthcare waste treatment and transfer station and SR 2013 No.1: treatment of 100 tonnes a year of clinical and healthcare waste.

The key changes to the existing standard rules set 2008 No. 24 include: 

- Reduced total annual quantity of waste on site from 75,000 tonnes per year to 5,000 tonnes per year.

The maximum quantity of non-hazardous waste stored at any one time shall not exceed 20 tonnes.

The maximum quantity of hazardous waste stored at any one time shall not exceed 10 tonnes.

- Addition of certain waste codes not currently included in the SR set:

The inclusion of European Waste Catalogue codes (EWC) from Chapter 15 - related to healthcare waste only.

The inclusion of some dual coded wastes in the Chapter 18 section.

- Updated operating techniques to reflect the revised healthcare waste appropriate measures guidance including:

Reduced storage times for waste on site: Offensive waste types can be stored for up to 7 days if outside, or for up to 14 days if stored in a building; Infectious waste and refrigerated anatomical waste can be stored for up to 14 days; Unrefrigerated anatomical waste can be stored for up to 24 hours, or up to 72 hours if over a weekend.

Wastes to be stored in a building: Storage and handling of infectious, pharmaceutical, chemical, anatomical and palletised wastes securely within designated areas of a secure building; Storage and handling of offensive wastes in a secure building or in secure, fully enclosed, rigid, waterproof and leak-proof bulk containers.

The removal of existing standard rules set 2008 No.25 and 2013 No.1.

What a standard permit is:

Standard permits contain one condition which refers to a fixed set of standard rules that an operator must comply with. The rules define the activities that an operator can carry out and specify necessary restrictions on those activities, such as emission limits, the types of waste or raw materials that can be accepted at the sites. The standard rules will be published on GOV.UK following public consultation.

Any operator who wishes to carry out a particular activity at a specific site or sites can look at the standard rules and, if they can comply with them, can apply for a standard permit.

There is no right of appeal against the rules in a standard permit because applying for a standard permit is voluntary. If an operator wants to change the way their site operates, they must apply to vary the standard permit to a bespoke permit when:

• their operation falls outside the scope of the standard rules.

• they feel that the standard permit no longer works for their particular operation.

The generic risk assessment for this activity

We have produced a revised generic risk assessment for the activity. This lists the potential risks and how to properly manage them. We did it by identifying possible pathways from the sources of the risks to the receptors (these are people, animals, property and anything else that could be affected by the hazard). The risk assessment is split into three sections.

1. Data and information - this section is made up of receptor, source, harm and pathway information that is relevant to the activity under consideration.

2. Judgement - we have done the risk assessment to work out the likelihood of the receptors being in danger from the hazard, the consequences of the hazard happening and the overall size of the risk.

3. Action - risks will be controlled by setting standard rules. For example, for noise and vibration management, compliance with a relevant noise and vibration management plan will be required where necessary. We will control residual risks by doing compliance assessment, such as site inspections, to ensure that the operators comply with the rules.

Why your views matter

The purpose of this consultation is to engage with relevant stakeholders to obtain their views on the proposed revised standard permit and removal of the two rule sets. We will review the feedback from respondents and alter the draft rules if appropriate.

Standard rules consultation no 23_proposals for healthcare waste permits - Version: 1.0

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What happens next

Thank you for responding to this consultation.

We will make your response publically available (excluding personal information and financial data) on our online tool once the consultation has closed, unless you have requested that we do not publish your response.

Following the end of the consultation we will also produce a consultation response document and this will be published on this consultation’s web page. If you have given us your email address, we will email you to let you know when this has been published.

Regards,

Waste Regulation – Treatment, Transfer & Storage, Environment & Business

Audiences

  • Members of the public

Interests

  • Environmental permitting