Guidance

Radioactive substances regulation (RSR): objective and principles

Published 1 December 2021

Applies to England

The Environment Agency’s corporate strategy is EA2025 Creating a Better Place. EA2025 identifies 3 long-term goals:

• a nation resilient to climate change
• healthy land, air and water
• green growth and a sustainable future

These goals seek to demonstrate how we contribute to a range of other plans including the:

• United Nation’s Sustainable Development Goals
• Defra 25-Year Environment Plan
• Defra group corporate plans

We are implementing EA2025 through 3 Strategic outcome plans and more detailed Local outcome plans.

Radioactive substances regulation (RSR) is included within these plans and so the Environment Agency’s long-term goals are also RSR’s goals.

The RSR objective and principles are not strategic goals and do not repeat the objectives set out in EA2025. Instead, they are a statement of the:

• fundamental objective of our regulation
• regulatory principles that we apply when carrying out our work

The RSR objective and principles:

• guide our decision-making
• provide transparency to permit holders
• give confidence to stakeholders
• enable the RSR function to play its part in achieving the Environment Agency’s strategic goals

The RSR objective

Our objective in regulating radioactive substances is to protect people and the environment from the harmful effects of ionising radiation, now and in the future. We also aim to protect and enhance the environment as a whole. We fulfil this objective by applying relevant legislation, government policy and international standards.

We have a specific RSR objective because the regulation of radioactive substances is different to other aspects of environmental regulation. RSR is a goal-setting regime based on the work of the International Commission on Radiological Protection (ICRP).

The ICRP is an independent, non-governmental organisation whose mission is to provide recommendations and guidance on protection from ionising radiation.

The RSR objective is strongly linked to the fundamental safety objective established by the International Atomic Energy Agency (IAEA):

“…to protect people and the environment from harmful effects of ionising radiation.”

The IAEA is an inter-governmental forum for scientific and technical co-operation in the nuclear field.

Many activities that we regulate in RSR have the potential to affect people and the environment for many generations to come, particularly activities involving the final disposal of solid radioactive waste.

In our RSR objective we state explicitly that people and the environment must be protected in the future, as well as today. To meet this objective, we must make sure that decisions we take now will keep risks from radiation in the environment as low as reasonably achievable (ALARA) for future generations as well as today’s.

Our objective reflects the Environment Agency’s principal aim as set out in the Environment Act 1995:

“… to protect or enhance the environment, taken as a whole, as to make a contribution towards attaining the objective of achieving sustainable development…”

For example, we may need to protect people and the environment from effects other than ionising radiation, and we can enhance the environment through our regulation of legacy issues and historic contamination.

Principles for radioactive substances regulation

These are our principles for radioactive substances regulation.

Principle 1: justification

We will only grant a permit for a practice involving radioactive substances if it is justified. Decisions we make about the remediation of land contaminated with radioactivity, or in emergencies, should do more good than harm.

Justification is one of the 3 fundamental principles of radiological protection established by the ICRP. Justification means that an activity that could cause exposure to ionising radiation should do more good than harm.

Radioactive substances activities are considered justified if the benefits they provide outweigh the health detriment from radiation exposure caused by the activity.

Under the Justification of Practices Involving Ionising Radiation Regulations 2004, the government decides whether new activities are justified and maintains a register of justified practices. Existing practices, those legally carried out in the UK before 6 February 2018, are also accepted by government as justified.

We will only issue a permit for a radioactive substances activity that the government considers to be justified , or an activity where separate justification is not required (for example, radioactive waste disposal facilities).

The principle of justification also applies when we act to remediate land contaminated with radioactivity from historic activities, and when we respond to emergencies such as a nuclear accident.

Principle 2: optimisation

Radiological protection must be optimised to make sure that people’s exposure to ionising radiation from the disposal of radioactive waste is kept as low as reasonably achievable (ALARA), taking into account environmental, social and economic factors.

Optimisation is the second of ICRP’s fundamental principles of radiological protection. It is the principle of making sure that radiation exposures are ALARA in any given circumstances.

Optimising radiological protection means planning for and managing exposures so that they are the lowest that can reasonably be achieved. It does not mean minimising radiation exposure regardless of the consequences of doing so.

Deciding what can reasonably be achieved must take into account the environmental, social and economic factors associated with the activity creating the exposure.

Optimisation decisions balance the health detriment to people associated with the radiation exposure with the other benefits and detriments of the option being considered. Other benefits and detriments could include the:

• effects of ionising radiation on wildlife and the environment
• effects of non-radioactive hazards on people, wildlife and the environment
• social impacts on communities
• costs and economic impacts

We have a duty through the Environmental Permitting Regulations (EPR) 2016 to make sure radiological protection is optimised in our regulation of activities that generate radioactive waste. The government’s statutory guidance to us on radioactive discharges also establishes optimisation of radiological protection as one of the principles on which we should base our regulatory decisions.

Optimisation needs to be viewed as part of a bigger picture, recognising that there will be competing claims for limited resources, and that nothing is completely risk free. Optimisation involves making choices between alternatives, for example, different pieces of equipment, operating techniques or methods of waste treatment. The option identified by the optimisation process can be considered as the best available technique (BAT) (see principle 8). It provides a low level of radiological risk, but is not necessarily the option with the lowest possible risk.

Optimisation decisions are constrained by the circumstances present at the time, but should consider current benefits and detriments and, to the extent possible, those in the future. Optimisation is an iterative process that continues throughout the lifetime of the radioactive waste activity.

When we determine a permit, we must have regard to the dose constraints for members of the public that are set out in EPR 2016. Dose constraints support the optimisation process. They do this by restricting the range of options that can be considered, and the radiation dose that individuals may receive from a particular source, or several sources in the same location.

The effort and resources put into optimisation should be proportionate to the magnitude of the risks from the options being compared. There is no lower level of risk below which optimisation is not required, but there are diminishing returns as the risk is progressively driven lower.

Optimisation focuses on the radiological protection of people. Other living organisms should also be protected (see principle 4) but we are not obliged by law to make sure the exposure of wildlife is ALARA. Protection of the environment is considered in achieving a balanced outcome from the optimisation process.

Stakeholder engagement

When carrying out optimisation, it is important to have input from stakeholders who are likely to be directly or indirectly affected by the detriments and benefits of the options being considered. The process should be open and inclusive, while also being proportionate.

We consult members of the public and other stakeholders during our environmental permitting process. This is set out in the Environment Agency’s policy on when and how we consult on environmental permits. In regulating radioactive substances activities, we may go further by engaging with stakeholders to:

• provide access to a wide range of relevant information
• make sure our decisions are informed by stakeholders’ views
• explain the basis for our regulatory decisions

Principle 3: dose limitation

Radiation doses to the public from radioactive substances activities must be kept within statutory dose limits.

Dose limitation is the third of ICRP’s fundamental principles of radiological protection. It is there to make sure that no individual bears an unacceptable risk of harm when the principles of justification and optimisation are applied.

We must make sure that no radioactive waste activity causes the dose limits for members of the public to be exceeded.

The dose limits for members of the public are:

• 1 mSv per year effective dose
• 15 mSv per year equivalent dose to the lens of the eye
• 50 mSv per year equivalent dose to the skin averaged over any 1 cm² area of skin

The limits do not apply to doses from:

• nuclear accidents or radiological emergencies
• natural background radiation
• medical irradiation

Anyone intending to apply for (or vary) a permit for a radioactive waste disposal must explain the radiation doses that the public will receive from their activity. We set limits to make sure that radioactive discharges and the final disposal of solid radioactive wastes do not exceed the legal dose limits.

Environmental monitoring

We carry out a programme of independent environmental monitoring of radioactivity across England. We use the data from this programme to assure us that the conditions we place in permits:

• provide the necessary protection
• demonstrate that the legal dose limits have been met

Principle 4: protecting wildlife

Radioactive substances activities must not cause wildlife to be exposed to levels of ionising radiation that would have adverse consequences for ecosystems, designated conservation sites and protected species.

The aim of principle 4 is to protect the health and status of natural habitats and communities of living organisms. Wild animals and plants must be protected against radiation exposure that would have adverse consequences for a population as a whole, or for features of a designated site. For certain protected species, we also need to protect individual members of a population.

This principle supports our statutory obligations, set out in a range of legislative provisions, to ensure both the:

• conservation of flora and fauna
• protection of designated habitats and species

We fulfil these obligations through our permitting process.

There are currently no statutory criteria for determining the level of exposure to ionising radiation that causes harm to wildlife. However, there is considerable national and international work underway on this subject. We take account of this work in our regulation of radioactive substances. We also contribute to the development of environmental radiological protection through funding research and development programmes and international engagement.

Principle 5: non-radioactive hazards

People and the environment should be protected from the non-radioactive hazards of radioactive waste to a level that is consistent with that provided by the relevant legislation, policy and guidance for non-radioactive substances.

Radioactive waste has a separate legal definition to the general definition of waste that comes from the Waste Framework Directive. Once a waste has been defined as radioactive waste, the controls that apply to non-radioactive (Directive) waste do not apply. Therefore radioactive waste cannot be regulated as Directive waste. The only exceptions to this are for certain wastes regulated under a radioactive substances exemption.

Some radioactive wastes may have non-radioactive properties that need to be controlled. In line with government guidance, we make sure the environment is protected from the non-radioactive hazards of radioactive wastes.

We expect non-radioactive hazards to be managed to standards consistent with those for Directive waste and non-radioactive discharges. Whilst we may not apply the same specific standards, our aim is to make sure we have a consistent level of environmental protection if radioactive waste has associated non-radioactive hazards.

Principle 6: security of radioactive substances

To protect people and the environment from the consequences of criminal acts and deliberate misuse, radioactive substances must be protected by an adequate level of security.

We regulate the security of radioactive material and waste, except on nuclear licensed sites or when it is in transit.

For the most hazardous radioactive sources (high-activity and similar sealed sources) we have a statutory duty to make sure the security measures in place:

• are appropriate to the source and the premises
• provide an adequate level of security to protect the source from theft or unauthorised access

We consult with the police and security services in determining what are appropriate and adequate security measures. In line with international standards, our permits require that operators with the most hazardous sources put in place prescribed security measures. We do not issue permits until we are satisfied that these measures are in place.

Principle 7: lifetime planning for radioactive substances

Radioactive substances should be managed throughout their lifetime to make sure people and the environment are protected both now and in the future.

Some radioactive substances remain hazardous for very long periods of time. We must address these long, sometimes inter-generational timescales when regulating them. Lifetime planning means addressing the fate of radioactive substances from the earliest stage of their use through to the point where they can no longer cause harm to people or the environment.

Our work is specifically aimed at:

• making sure radioactive substances activities only take place when they are justified, optimised and subject to limits
• preventing the unnecessary generation of radioactive waste
• making sure that radioactive sources are only used if there is a viable disposal route for them
• making decisions now to protect future generations from the harmful effects of radioactive waste disposals

But we do not just focus on radioactive waste disposal. We also regulate how the BAT are applied to radioactive substances activities so that they are designed, built, operated and decommissioned to meet these aims (see principle 8).

We require anyone carrying out a radioactive substances activity to have a plan to control and manage radioactive materials and wastes to make sure they protect people and the environment throughout the lifetime of that activity. We do this by:

• working with operators before they introduce a new activity to understand their plans for using radioactive substances and to explain what their permit will require them to do
• assessing an applicant’s plans to apply BAT throughout the lifecycle of the activity (see principle 8) before we grant a permit
• assessing whether an applicant is a suitable person or organisation to manage radioactive substances over a long time period – that they are both technically and financially competent
• requiring operators of nuclear sites to have radioactive waste management arrangements to support lifetime planning for their radioactive wastes, including a waste management plan and a site wide environmental safety case
• requiring holders of high activity sealed sources to have adequate financial provision to make sure that when their sources are no longer required they can dispose of them or return them to the manufacturer
• working with other organisations to make sure that wastes that currently have no disposal route can be disposed of when a route becomes available
• making sure that operators leave their site in a condition that is safe for people and the environment before we accept the surrender of a permit

Principle 8: BAT

Operators must use BAT for the management of radioactive waste.

We follow the government’s statutory guidance on aerial and liquid radioactive discharges which lists using BAT as one of the principles on which we should base our regulatory decisions. The statutory guidance states that we should make sure that BAT is used to:

• prevent the unnecessary creation of radioactive waste or discharges
• minimise the quantity and activity of any radioactive waste that is created
• minimise the impact of discharges on people and the environment

We have applied this approach as a general principle to the accumulation and disposal of all radioactive wastes that we regulate.

BAT is the outcome of a systematic and proportionate examination of alternative options that gives due regard to the waste hierarchy. This is the optimisation process (see principle 2).

BAT is how the operator manages disposals of radioactive waste into the environment so that the public’s exposure to ionising radiation is kept ALARA, and the environment is protected.

The ‘techniques’ in BAT include both the technology used and the way in which a facility is designed, built, maintained, operated, dismantled and the site restored.

There are many different techniques and measures that together make sure an activity is operated using BAT. What constitutes BAT will change over the lifetime of an activity. This could be a result of changes to the:

• nature or scale of the activities undertaken
• techniques available
• external environment around the activity

Operators must periodically review their activities and ensure that they are using BAT at all times.

Principle 9: the precautionary principle

Lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent serious or irreversible harm to people and the environment.

The precautionary principle was developed by the UN Environment Programme in the 1980s and gained worldwide acceptance in the UN Rio Declaration on Environment and Development of 1992.

The government’s statutory guidance on radioactive discharges recommends that we take a precautionary approach with our regulatory decision-making. For example, if we are uncertain about the effects of a radioactive waste disposal we will still consider taking measures to protect people and the environment from significant harm.

Principle 10: the polluter pays principle

The person or organisation responsible for the facilities and activities that create radiation risks is responsible for protecting people and the environment and must bear the associated costs.

The polluter pays principle is a fundamental principle of environmental protection that originated from the Organisation for Economic Co-operation and Development (OECD) in 1972. It has been endorsed in national and international law and policy.

The original principle states that:

“…the costs of pollution prevention, control and reduction measures are to be borne by the polluter.”

We have chosen to align our version of this principle more closely with IAEA Fundamental Safety Principle 1 to make it more specific to our regulation of radioactive substances.

The principle emphasises that responsibility includes bearing the costs of making sure that people and the environment are adequately protected. The government’s statutory guidance to us on radioactive discharges lists the polluter pays principle as one of the principles on which we should base our regulatory decisions.

Generic developed principles

The RSR objective and principles in this document have replaced the RSR fundamental principles set out in our 2009 publication ‘Radioactive Substances Regulation – Environmental Principles, Regulatory Guidance Series, No RSR 1’. We have withdrawn this publication.

RSR 1 also contained generic developed principles on a wide range of topics. These are still part of our current guidance and we have published these separately in our document RSR generic developed principles: regulatory assessment.

We are reviewing and updating RSR guidance and plan to incorporate these generic developed principles into other topic-specific guidance as we carry out this review.

We have also withdrawn the generic developed principles on regulatory process that were in RSR 1. They are no longer part of our current guidance.