Guidance

Environmental permitting and the role of the UK Health Security Agency (UKHSA)

Updated 26 April 2024

Introduction

Purpose of this publication

This guide sets out the way the UK Health Security Agency (UKHSA) responds to consultations on environmental permit applications made to the Environment Agency (EA) in England. UKHSA may also be consulted by local authorities who regulate lower risk activities.

UK Health Security Agency

On 1 October 2021, Public Health England (PHE) ceased to exist and was replaced by the UK Health Security Agency (UKHSA) and the Office for Health Improvement and Disparities. UKHSA is an executive agency sponsored by the Department of Health and Social Care.

The principal aims of UKHSA are to protect every member of every community from the impact of infectious diseases, chemical, biological, radiological and nuclear incidents and other health threats to make the nation’s health secure.

Environment Agency

The EA is an executive non-departmental public body sponsored by the Department for Environment, Food and Rural Affairs (Defra). The principal aims of the EA are to create better places for people and wildlife, and support sustainable development.

Regulatory background

The environmental permitting regime requires that those carrying out certain activities, such as those that could pollute the air (water or land) or involve waste, hold an environmental permit. The framework was originally created in 2007 combining the Pollution Prevention and Control (PPC) and Waste Management Licensing (WML) Regulations, to simplify the process of applying for, regulating and measuring compliance.

The Environmental Permitting Regulations 2016 SI 2016/1154 came into force on 11 December 2016, replacing the Environmental Permitting Regulations 2010 SI 2010/675. The scope of the 2007 regulations was broadened by revisions in 2010 to include discharges to water and groundwater activities, radioactive substances and provision for a number of European directives, including the Mining Waste Directive (2006/21/EC). Further amendments were made in 2013 to transpose the Industrial Emissions Directive (2010/75/EU) into domestic legislation. The regulations provide industry and regulators with a single permitting and compliance system.

The regulations require operators to obtain permits for specified activities, to register others as exempt, and provide for ongoing risk-based compliance assessment by the regulators. High-risk facilities, which are often larger and more complex, are regulated by the EA and are referred to as Part A(1) installations or Part A activities. Medium and low-risk processes are regulated by local authorities and are known as Part A(2) and Part B activities, respectively. A generic term for any activity specified in the regulations is a ‘regulated facility’.

Further information on the different classes of regulated facilities can be found in the Environmental permitting core guidance issued by Defra. The current guidance is aimed principally at those activities regulated by the EA, which generally have a far greater potential to pollute the environment.

In addition, the EPR guidance has been developed for installations regulated under the relevant industrial emissions directive. The regulations require that all appropriate public consultees are informed of certain permit applications. ‘Public consultee’ means a person whom the regulator considers is affected by, is likely to be affected by, or has an interest in, an application. The Public Participation Directive (2003/35/EC) (PPD), updated in 2016, was issued by the European Commission in order to provide members of the public with opportunities to participate in the permitting and ongoing regulation of certain categories of activities within member states and this has been transposed into UK law. Under the Environmental Permitting Regulations 2016, there are no statutory consultees and organisations such as UKHSA are classed as ‘public’.

Consultation and public participation enable members of the public and other interested organisations (such as public health bodies) to provide comments to the regulator on aspects relating to potential environmental, including human health impacts. As a requirement of this process, the EA developed a public participation statement which subsequently led to ‘working together agreements’ between the EA and organisations such as UKHSA, the Health and Safety Executive and the Food Standards Agency.

UKHSA’s role

When consulted, UKHSA provides an expert and independent opinion to the regulator (EA) on the potential human health impacts of emissions arising from existing or proposed regulated facilities at the permit application stage. This assists the regulator in making decisions on whether or not to grant permits to regulated facilities.

The EA and PHE working together agreement details the role of both agencies in relation to environmental permitting and is accompanied by a risk-based screening tool which includes agreed criteria to identify those activities on which UKHSA will be consulted. The aim of the working together agreement is to ensure the protection of public health in relation to activities prescribed under the Environmental Permitting Regulations 2016, taking a risk-based approach to the permitting of regulated activities.

When an activity requires a permit to operate, there are 2 types of permit:

• bespoke permits
• standard rules permits

The EA has developed standard rules permits and associated generic risk assessments for certain activities where the risks are well understood, assessed and mitigated. Any activity that can be demonstrated to comply with the set of standard rules is considered to present a low risk to the environment, including human health, negating the requirement for a more detailed assessment to be undertaken by both the operator and the EA.

When an activity meets the criteria for a standard rules permit, a permit will normally be issued without wider consultation, including with public health bodies such as UKHSA or local directors of public health (DsPH). These will define the activities that an operator can carry out and specify necessary restrictions, such as waste types, volumes and emissions. However, UKHSA can comment on the set of standard rules when they are issued for public consultation.

For activities which do not meet the criteria for a standard rules permit, a bespoke application will be required. These applications are assessed against the agreed risk-based screening criteria. UKHSA and DsPH will then be consulted on those meeting the criteria.

Applications for a variation may also be received where a change is needed to a permit. These can be ‘normal’ or substantial’. Where the changes require a significant assessment of the risk to the environment or human health then a substantial variation is applied for and UKHSA and DsPH will be contacted. UKHSA will be consulted on these.

The screening criteria will be periodically reviewed by the EA and UKHSA and updated, but examples of sites that would normally meet the screening criteria for consultation with UKHSA are as follows:

• combustion plant >50 MW rated thermal input (excluding all Medium Combustion Plant Directive (MCPD) applications)
• waste incineration or co-incineration plant
• landfill sites (excluding inert landfills)
• composting and biological treatment sites
• where the H1 assessment indicates a need for air dispersion modelling to be carried out, including MCPD applications
• when an operator derived Environmental Assessment Level (EAL) is proposed and we determine that we need UKHSA to assess if the applicant’s EAL is acceptable to protect public health
• containing a Human Health Risk Assessment or Health Impact Assessment
• for applications that require submission of a site-specific emissions management plan (dust, odour) and where the location of the facility shows that public health sensitive receptors (see below) are present within 400m of the site
• for intensive farming applications where there are public health sensitive receptors (including those living on the farm) within 100m of the site
• an application that relates to onshore oil or gas
• Control of Major Accident Hazards (COMAH) sites (as indicated on the application form)
• any application with a fire prevention plan, if the applicant proposes to depart from the objective of aiming for a fire to be extinguished within 4 hours
• any other application of high public health interest (historic or current) or which in the professional judgement of the permitting officer has potential health risks associated with it

UKHSA is also consulted on sites involving radioactive substances, including:

• new nuclear sites
• existing nuclear sites where the discharge limits or doses to the most highly exposed people are increasing and the estimated doses from the site exceed 20 microsievert (µSv) in a year
• non-nuclear sites from time to time, as agreed between the agencies

In addition to responding to consultations on environmental permits, PHE published guidance on the risks to public health from certain activities covered by the regulations.

Following the granting of a permit, UKHSA will continue to work with the regulator to advise on any issues relating to public health that may arise from regulated facilities.

Role of public health teams in local authorities

Local authority public health teams also have a role to play in protecting and improving the health of local populations (as outlined in the Health and Care Act 2022).

Local authority public health teams, via the DsPH, are also consulted on environmental permit applications directly by the regulator.

They may use their local knowledge, potentially in conjunction with the UKHSA response, to:

• identify any existing local health issues that may be associated with the regulated facility or its location
• discuss with the local community any concerns they may have on any potential health risks associated with a regulated facility

UKHSA copies its responses to environmental permit consultations to the relevant local authority for their information.

Role of the operator

The responsibility of the operator (applicant) of the regulated facility is to provide sufficient information to enable the regulator to determine the application and grant a permit. Operators are provided with generic guidance or guidance specific to their industrial sector to complete their application (1, 2) and apply best available techniques (BAT) which can be defined as follows.

‘Best’ means the most effective solution in achieving a high general level of protection of the environment as a whole.

‘Available’ means those techniques developed on a scale which allow implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced locally, as long as they are reasonably accessible to the operator.

‘Techniques’ includes both the technology used, and the way in which the installation is designed, built, maintained, operated and decommissioned.

The application should contain sufficient information to demonstrate that there is not a risk of significant pollution from the site and hence that the operator is achieving, or will achieve, a high level of protection for human health.

A typical application will consider a range of environmental issues including:

• a satisfactory environmental management system
• adequate compliance monitoring
• an assessment of polluting releases during normal and abnormal operations
• compliance with environmental quality standards, domestic regulations and any relevant legacy European directives
• waste minimisation and management
• prevention of accidents

Once an application has been reviewed, assessed and accepted, the EA will issue a permit containing relevant conditions. The operator then has an ongoing commitment to ensure compliance with the conditions of the permit for the regulated facility.

Reviewing environmental permit applications

Based on the content of applications and experience to date, a range of skills is required to provide appropriate and effective advice based on an environmental permit application.

The necessary skills and background of UKHSA staff include an understanding of:

• environmental chemistry and pollution pathways
• toxicology
• public health
• radiation protection
• epidemiology
• risk assessment methodologies
• risk communication, to put risk into context

What UKHSA considers when reviewing environmental permit applications

The aspects of an application that are considered from a public health perspective by UKHSA are grouped into individual sections below.

Local area and local industrial landscape

When assessing an environmental permit application, UKHSA will consider the following, dependent on the nature of activities at the site:

• other existing significant sources of pollution, such as other industries and traffic
• proximity to key receptors, like sensitive members of the population, in relevant settings where known, such as houses, hospitals, allotments, nursing homes and schools, and also pollutant pathways, such as agricultural land (food) and water courses (recreational waters)
• sources of drinking water identified by the applicant, such as private or public water supplies including boreholes, and local abstraction points for industry, food and agriculture

Impact of emissions and activities

The potential impact of emissions from regulated facilities that could potentially affect health may be grouped into 3 categories:

• source of the pollution
• pollutant pathway
• human receptors

This is commonly referred to as the source-pathway-receptor risk assessment model.

Table 1. Visualisation of the source-pathway-receptor model with examples

Source	Pathway	Receptor
Hazard identification: • nature of hazard • CAS number • concentration • volume • exact location	Exposure assessment: • direct or indirect • air, land, water, food	Risk characterisation: • sensitive receptors • time of exposure • duration of exposure • dose of exposure • symptoms

Source

The applicant should identify all sources of pollution and quantify them. This should not only include authorised releases to the environment (for example emissions to air or water) but also include any potential unauthorised or unintended emissions (like fugitive releases of dust from stockpiles, fugitive releases from vents or the potential of releases from accidents).

The operator should quantify sources using monitoring data, if available. Data should be as comprehensive as possible and up to date – for example, data from a stack-monitoring programme undertaken 10 years earlier may have little relevance to current or future emissions.

In the absence of actual data, any predicted values should be derived from models (such as mass balance calculations, screening tools or air dispersion modelling) that are recommended for this particular purpose. The methodology and limitations of any model used to predict such values should be clearly explained. Sufficient information should be provided to demonstrate that any assumptions used are justified and appropriate scenarios modelled.

Pathway

The application should explain how local people (receptors) will be exposed to the pollutants from the regulated facility. Examples of pathways include inhalation of vapours or dust, contact with contaminated soil or consumption of contaminated drinking water. Again, it is the responsibility of the applicant to identify all possible exposure pathways, but UKHSA may review the appropriateness of these pathways and suggest others that may have been omitted or poorly considered.

Receptor

The application should assist in determining who may be exposed to emissions from the regulated facility (see also local area above). While it is the responsibility of the applicant to identify the most likely receptors, UKHSA will identify local receptors that may be particularly vulnerable (such as people in nursing homes and schools).

Risk assessment

Applications may contain a variety of different approaches to assessing risk, from the use of initial screening tools to predict the likely impact of releases such as the EA H1 environmental risk assessment tool, to detailed plume dispersion modelling (3).

Applicants may also use simple qualitative risk assessments to identify and qualify sources, pathways and receptors in terms of the likely severity of outcome (high, medium or low risk).

Applicants are expected to consider the following:

• demonstration that the application of BAT prevents or reduces emissions, and limits the impact of the regulated facility on the environment and human health
• consideration of other existing sources of pollution, including background levels of pollution
• quantification of ‘high risk’ outcomes – for example, if a qualitative risk assessment suggests that the outcome to receptor A exposed by inhalation to substance X is high or severe, a more detailed assessment is necessary
• where environmental management systems are in place, evidence that the pollution that the management systems are designed to deal with should be prevented or minimised
• effective accident management, including Fire Prevention Plans, which is particularly relevant for sites with significant hazards (such as COMAH sites)

Assessment of air quality impacts

The most usual approach to assess the impact of air emissions is for the applicant to make use of health-based standards or other benchmarks to judge the relative impact of a chemical release. For example, stack emissions (actual or predicted) may be compared against prescribed emission limit values (ELVs) and data on predicted ground level concentrations may be compared against relevant air quality standards.

Applicants need to consider the following relevant sources of health-based standards when assessing the public health impact of emissions to air from regulated facilities. This is to ensure that operators comply with relevant health-based guidelines which are evidence based and scientifically robust. In all cases the assessment should be underpinned by an assessment of the site-specific circumstances and local conditions.

Predicted environmental concentrations (the sum of estimated emissions to air and background concentrations) or ambient air concentrations should be compared with:

• UK health-based environmental standards or guidelines, such as those set by the Committee on the Medical Effects of Air Pollutants (COMEAP) and the environmental assessment levels (EALs) derived by the EA. The EALs represent a pollutant concentration in ambient air at which no significant risks to public health are expected; where there are no published EALs, operators may derive and propose an alternative for consideration on a site-specific basis, which will be assessed for acceptable protection to public health
• international standards, like standards and guidelines from the World Health Organization, the European Commission or European member states, the US, Canada, Australia and New Zealand
• emission limit values (ELVs), usually determined by BAT, as defined above, and associated legislation
• other expert opinion based on existing good industry practice or current regulatory practice

UKHSA takes into account data on background pollution concentrations when assessing the impact of emissions on the environment. It is important that the applicant places the emissions into a local context so that an assessment of the overall human exposure to a substance can be made, especially in air quality management areas (AQMAs), where a local authority has identified an area where improvements in air quality are required.

In particular, the EA H1 environmental risk assessment tool can be used to assess the impact of emissions in relation to existing pollution levels in a particular location. It is a useful screening tool for assessing the impact of proposed emissions and in determining whether a more detailed assessment is required. The applicant should use the most appropriate data to estimate both the process contribution and the likely background level of pollution and justify emission rates used throughout the H1 assessment (4).

The regulations require that permits are only issued where the regulator is satisfied that the operator is applying BAT to ensure protection of the environment, and that the operation of the regulated facility will not breach environmental quality standards (EQS). However, the EQS must be met by the installation even if this means the regulator implementing a stricter ELV at the emissions source than can be attained through BAT (5).

In some cases, applicants may simply compare stack emissions with relevant sector specific ELVs. Without consideration of background air pollution, such a comparison has limited public health value. Where such an assessment has been undertaken, UKHSA may recommend that the regulator consider asking the applicant to place their emissions into a local context or confirm that emissions are not significant in terms of local air quality.

Radiation

Environmental permits are issued to regulate the disposal of waste involving radioactive sources on the 27 licensed nuclear sites in England. Nuclear sites include nuclear power stations, nuclear fuel fabrication sites and radioactive waste disposal facilities, naval dockyards for nuclear submarines and manufacturers of nuclear weapons. About 1,200 non-nuclear sites, such as hospitals, universities and industry, use radioactive substances for a wide range of applications – for example, in the diagnosis and treatment of patients, controlling the raw material used in manufacturing processes or testing the safety and quality of pipes, boilers and vessels. These sites hold environmental permits regulating the keeping and use of radioactive sources and the accumulation and disposal of radioactive waste.

UKHSA reviews applications for permits for new nuclear sites (for example new nuclear power stations, even if on an existing nuclear site) regardless of the estimated doses, and for existing nuclear sites where the discharge limits or doses to the most highly exposed people are increasing and the estimated doses from the site exceed 20µSv in a year. In particular, UKHSA considers the assessment of the potential radiation exposures of members of the public resulting from discharges to the environment. The principles for these assessments are outlined in EA guidance: Principles for the Assessment of Prospective Public Doses arising from Authorised Discharges of Radioactive Waste to the Environment. UKHSA also reviews applications for non-nuclear sites where there may be radiological public health concerns or increased public interest, for example unconventional gas, incinerator and landfill sites. UKHSA does not typically review applications for permits for sealed sources, like gamma radiography sources used to check welds on pipework, or permits for the disposal of small amounts of radioactive waste from sites such as hospitals, laboratories and universities.

Environmental management

Poor management practices can present a risk to local communities as they can result in poor environmental performance. The risk assessment provided with the application is only valid if it is supported by a clearly defined and transparent environmental management system (EMS), of which a summary would be provided with the application. A good EMS can result in reduced emissions, regulatory compliance and reduce the severity and impact of spills, leaks and other accidents. UKHSA would expect to see evidence of such a system. Management plans for specific emissions would also be expected where applicable (odour, noise, bioaerosols).

Bioaerosols

Bioaerosols are naturally occurring bacteria and chemicals found in the air, produced when organic matter, particularly compost, decomposes. They have been linked to health effects including respiratory problems, nausea, headaches and fatigue. There are a number of permitted processes such as intensive farming and composting sites that may lead to the production of bioaerosols. UKHSA is undertaking a systematic review of the potential public health risks from bioaerosols associated with intensive farming and non-hazardous waste disposal.

What UKHSA does not consider when reviewing environmental permit applications

UKHSA does not consider, statutory nuisance, pollution of controlled waters or psychological impacts such as stress.

How members of the public can participate

The EA has produced a public participation statement.

This guide details the mechanisms for consulting on permit applications and provides contact details if local residents wish to discuss concerns they may have relating to a regulated facility. Advertisements of applications made under the Environmental Permitting Regulations 2016 are available to view online.

More information

Department for Environment, Food and Rural Affairs

Establishing the Best Available Techniques for the UK (UK BAT)

Environmental Permitting Guidance: Core guidance: For the Environmental Permitting (England and Wales) Regulations 2016

Industrial Emissions Directive EPR Guidance on Part A installations

Environment Agency

Check if you need an environmental permit

Principles for the Assessment of Prospective Public Doses arising from Authorised Discharges of Radioactive Waste to the Environment

Environmental permits: when and how we consult

Working together agreement: Environment Agency and Public Health England

References

1. Environment Agency, 2023. ‘Develop a management system: environmental permits’

2. Environment Agency, 2022. ‘Control and monitor emissions for your environmental permit’

3. Environment Agency and Department for Environment, Food and Rural Affairs, 2022. ‘Risk assessments for your environmental permit’

4. Environment Agency and Department for Environment, Food and Rural Affairs, 2022. ‘Air emissions risk assessment for your environmental permit’

5. Department for Environment, Food and Rural Affairs, 2013. ‘Industrial Emissions Directive EPR Guidance on Part A installations’