Statutory Environmental Targets (UK)

The Environment Act 2021 introduced a system of environmental governance based on statutory environmental principles and long-term environmental targets, and an Environmental Improvement Plan, all supported by an independent Office for Environmental Protection (operating in England and separately in Northern Ireland). Scotland does not have an OEP, it has set up a separate body under different legislation. Wales has no OEP.

Statutory targets were due (by law) by 31st October, but this deadline has been missed. The first review of the Environmental Improvement Plan is required by 31 Jan 2023. The current Environmental Improvement Plan is dated 2018 and the latest annual report on it is here. Annual reports are required by section 9 of the Environment Act 2021. Environment targets are governed by sections 1 to 7 of the Act. Section 10 stipulates reviews of the Environmental Improvement Plan.

In March 2022, the government announced a consultation on the targets. It closed on 27th June. The outcome of this consultation is not announced, nor are the statutory targets.

DEFRA responded to the OEP that it is committed to the target of halting species decline by 2030 which is included on the face of the Environment Act, and to bring forward the wider suite of targets specified under the Act.

The OEP is pressing for publication of the targets – here is their latest letter to DEFRA.

Included in the OEP’s letter to DEFRA is a non-exhaustive list of other statutory deadlines which appear to have been missed.

Habitats and Water Abstraction Court Case (UK)

On 6th September ’22, the High Court granted judicial review of an Environment Agency decision in 2021 to restrict their investigation of water abstraction impacts on Sites of Special Scientific Interest (SSSI) in Norfolk. The judgment is here. Local press is here.

The claimants were private citizens, farmers, living in the Norfolk Broads, freehold owners of a fen and other land, and concerned that water abstraction (for food production primarily) is causing irremediable damage to the environment, their own land, including ecosystems that are legally protected. Their intervention had been on going for 14 years, and had already been instrumental in the decision of the defendant, the Environment Agency, not to renew two abstraction licences. They successfully supported the Environment Agency’s decision to vary the two licences when that decision was challenged on appeal.

The Environment Agency was established by section 1 of the Environment Act 1995. By section 6(1)(b) of the 1995 Act, its duties include the promotion of the conservation of flora and fauna which are dependent on an aquatic environment. It is responsible for the grant (and variation and revocation) of licences for the abstraction of water.

Groundwater is water that is present in the ground. Many ecosystems (habitats and species) are dependent on a supply of groundwater. Groundwater may be abstracted (in the Norfolk Broads, from either the chalk, the crag, or the Sandringham sands) for use by the public water supply, industry, and agriculture. A licence is required to extract groundwater. Such licences may either be permanent (with no requirement to renew) or time limited (with the possibility of periodic renewal). The Environment Agency has power to revoke abstraction licences: sections 52 and 53 of the Water Resources Act 1991.

Once changes to an ecosystem are apparent, it may be too late to put matters right; by that stage, irremediable damage may have occurred. For this reason, Natural England (which has statutory responsibility for providing advice to the Environment Agency and others) is an interested party and had advised the Environment Agency in October 2020 that it was necessary to consider water supply in the Broads and to take any necessary action to restore ground and surface water levels. For the same reason, the Environment Agency itself recognises an obligation to apply a “precautionary approach to dealing with adverse effects” such that it must take appropriate and proportionate action to ensure that licenced water abstraction does not lead to adverse effects.

The Norfolk Broads is, in terms of rainfall, one of the driest parts of the country. Long- term average annual rainfall is between 600mm and 730mm. The low rainfall is exacerbated by periods of drought. The Broads also lie within an area where a great deal of irrigated fruit and vegetable production takes place. This is reliant on water abstraction. In the Bure and Thurne Reporting Area alone, more than 60 million litres of ground water and surface water are abstracted each day. So, there is a relatively small amount of rainfall, but a considerable amount of water is taken from the ground.

The claimants believe that the Environment Agency ought to review more broadly the impact of water abstraction to decide whether other licences should also be withdrawn or altered. The court case is the claimants challenge, seeking judicial review, of the Environment Agency’s refusal to expand the scope of an investigation that it had conducted in 2021 into the effect of 240 abstraction licences. That investigation concerned the impact of abstraction on just three Sites of Special Scientific Interest (SSSIs).

The Environment Agency accepts that it must have regard to article 6(2) of the pre-Dec 2020 European Habitats Directive. It maintained that it had done so and that it had, after taking it into account, reasonably decided to limit its investigation of the impact of the 240 licences to the three SSSIs. It disputed that article 6(2) has direct effect in domestic law beyond the obligation to “have regard” to it. Irrespective, it maintained that it was acting compatibly with the requirements of article 6(2).

The High Court determined that the GB Habitats Regulations (2017) continue to have effect in domestic law even though they are EU-derived domestic legislation: by means of sections 1B(7) and 2(1) of the European Union (Withdrawal) Act 2018specifically –

“The Habitats Regulations are thus retained EU Law: section 6(7) of the 2018 Act. It follows that they must be interpreted in accordance with retained EU case law and retained principles of EU law: section 6(3) of the 2018 Act.

” Questions as to the meaning and effect of retained EU law (so, including the Habitats Regulations, and the obligation under article 6(2) which continues to have effect under section 4) must be decided in accordance with retained general principles of EU law: section 6(3)(a). The precautionary principle is a retained general principle of EU law: section 6(7).

The High Court decided on 4 matters –

(1) The ambit of the obligation, under regulation 9(3) of the GB Habitats Regulations (2017), to “have regard” to the requirements of the pre-Dec European Habitats Directive, including whether that mandates compliance with article 6(2) of that Habitats Directive.

Decision – “…. the duty to “have regard” here does not implicitly permit the Environment Agency to act in a way that is inconsistent with the Habitats Directive (in other words to have regard to the requirements of the Directive but then deliberately decide to act in a way that is inconsistent with those requirements). Rather, it recognises that the Environment Agency is one part of a complex regulatory structure and, depending on the issue, it may have a greater or lesser role to play.”

“The duty on the Environment Agency to have regard to the requirements of the Habitats Directive means that the Environment Agency must take those requirements into account, and, insofar as it is (in a particular context) the relevant public body with responsibility for fulfilling those requirements, then it must discharge those requirements. In other words, the scope for departure that is ordinarily inherent in the words “have regard to” is considerably narrowed.”

“It is clear from all of the contemporaneous evidence (including internal emails) that the Environment Agency has regarded itself as bound by the Habitats Directive and has sought to act in compliance with its requirements”

(2) Whether article 6(2) of the pre-Dec 2020 Habitats Directive imposes an obligation of a kind recognised by the Court of Justice of the European Union (“CJEU”) or any court or tribunal in the United Kingdom in a case decided before 2021.

Decision – “…. by reason of section 4 of the 2018 Act, article 6(2) continues to be recognised and available in domestic law and is to be enforced accordingly.”

Detail – “The parties agree that the question of whether article 6(2) is enforceable by a UK court (irrespective of regulation 9(3) of the Habitats Regulations) turns on the application of section 4(2)(b) of the 2018 Act, namely whether the obligations under article 6(2) are of a kind recognised by the CJEU, or any court or tribunal in the United Kingdom, in a case decided before 11pm on 31 December 2020.”

“… That test is satisfied once a case is identified that recognises article 6(2) as being enforceable in domestic proceedings. The statute expressly provides that it is not necessary for that to be an essential part of the court’s decision. It is not relevant to the section 4(2) test to enquire as to whether the case was correctly decided or was decided per incuriam. The position might be different if the decision had been overturned on appeal, or later overruled, but that is not the case here.”

(3) Whether the Environment Agency has breached article 6(2) of the pre-Dec 2020 Habitats Directive by limiting its investigation of water abstraction to the three SSSIs.

Decision – “The claimants have demonstrated a breach of article 6(2) of the Habitats Directive and a breach of regulation 9(3) of the Habitats Regulations.”

4) Whether the Environment Agency acted irrationally by limiting its investigation of water abstraction to the three SSSIs.

Decision – “Having committed itself to discharge that obligation, it was irrational for the Environment Agency not to expand the RSA programme without having any alternative mechanism in place that could ensure compliance with article 6(2). It follows that even if (contrary to the findings I have made in respect of issues (1) and (2)) article 6(2) is not enforceable by the High Court, the Environment Agency’s decision is flawed on common law grounds. On this basis, the claimants’ rationality challenge also succeeds.”

Summary

(A) The claimants showed that water abstraction may be causing deterioration of protected habitats or significant disturbance of protected species within The Broads Special Area of Conservation.

(B) The Environment Agency must (by reason of regulation 9(3) of the Habitats Regulations) have regard to the requirements of article 6(2) of the pre-Dec 2020 Habitats Directive. It must therefore be in a position to justify any departure from those requirements. The Environment Agency’s obligation under article 6(2) continues to be enforceable in domestic law: section 4 of the 2018 Act. That obligation must continue to be interpreted in accordance with the precautionary principle: section 6 of the 2018 Act.

(C) The Environment Agency must take appropriate steps to ensure that, in the SAC (pre-Dec 2020 European Habitat designation adopted in UK law and applied to areas of Norfolk, including SSSIs), there is no possibility of the deterioration of protected habitats or the significant disturbance of protected species as a result of licensed water abstraction. The Environment Agency has discharged that obligation in respect of three sites of special scientific interest. But it has not done so in respect of all sites within the SAC. That is because its review of abstraction licences was flawed and (at least in relation to permanent licences) it has not conducted a sufficient further review to address those flaws. It is therefore in breach of regulation 9(3) of the Habitats Regulations and article 6(2) of the Habitats Directive.

(D) Having decided to comply with article 6(2), it was not rational for the Environment Agency to limit its investigation to just three sites without undertaking further work to ensure compliance with article 6(2) across the entire SAC.

The High Court will issue Directions.

This was a court case in which the claimants relied on a pre-Dec 2020 EU Directive to gain relief. The judgment confirmed the direct influence of EU Law if, prior to 1st Jan 2021, those rules had been found by a court (the CJEU or a local UK court) to be directly enforceable against public authorities.

The Prime Minister has promised to remove the influence of EU Law by end 2023. Please note my Blog post of some days ago re the forthcoming EOR Regulations (which when enacted may alter or revoke the 2017 Habitats Regulations).

The new DEFRA Secretary has cited water security as a key objective, along with food supplies.

Storm Water Overflows (England)

UPDATE: 7th September ’22 the new DEFRA Secretary wrote to water companies to write to him formally by 21st September ’22 with their plans to make significant improvements.

6th September ’22, an Urgent Question was asked (in the House of Commons) of the then DEFRA Secretary George Eustice about storm water overflows. His answers provided an update – (the DEFRA Secretary has now changed) –

(1) When appointed DEFRA Secretary in February 2020 Mr Eustice instructed officials to change the strategic policy statement for Ofwat to give the issue greater priority.

(2) The Environment Act 2021 sets a requirement for water companies to reduce the harm caused by sewage discharges.

(3) Water companies are investing £3.1 billion to deliver 800 storm overflow improvements across England by 2025. Mr Eustice stated this would deliver an average 25% reduction in discharges by 2025.

(4) In 2016, only 5% of storm overflows were monitored – almost 90% are now monitored, and Mr Eustice stated by next year 100% of all storm overflows would be required to have monitors fitted. There are 15,000 storm overflow discharge points in England.

(5) The Environment Agency and Ofwat have launched criminal and civil investigations into water companies, at more than 2,200 treatment works, following the improvements made to monitoring data. That follows 54 prosecutions against water companies since 2015, securing fines of nearly £140 million.

(6) The Environment Act 2021 makes it a legal requirement for companies to provide discharge data to the Environment Agency and to make it available to the public in near real time: within an hour.

(7) The Environment Act 2021 gives new powers to Ofwat to modify water company licence conditions. Mr Eustice stated Ofwat is currently consulting on proposals that will enable it to take enforcement action against companies that do not link dividend payments to their environmental performance or that are failing to be transparent about their dividend payouts. It’s possible the consultation referred to is one on PR24 here. Note Ofwat’s expectation (PR24) that investor returns would be linked to the ability of companies to create and deliver value for customers and the environment, and the expectation that companies would take significant action to improve the environment and resilience. The City Briefing of 7 July ’22 gives further detail – here.

(8) On 5th September ’22, the storm overflows discharge reduction plan (required by the Environment Act 2021) was laid before Parliament. This plan underpins the £56 billion of capital investment over the next 25 years cited by Mr Eustice and the initial £3 billion investment to reduce discharges by 25% by 2025 at point (3) above. The plan makes a priority of designated bathing waters and other priority sites with a target of 2035. The plan foresees significant reductions in discharges at 75% of high-priority sites. The government’s storm overflows discharge reduction plan (England) is here.

(9) On 27th June ’22, the Office for Environmental Protection announced its first investigation: of the roles of Ofwat, the Environment Agency and the DEFRA Secretary in the regulation of combined sewer overflows (CSOs) in England – the announcement is here.

(10) The Environment Agency’s costs for monitoring water companies’ permits for the management of combined storm overflows are cost-recovered through the permit. In addition, Mr Eustice said the government provides some support.

(11) Southern Water is one of the companies that was recently investigated, and it was subject to a record fine of close to £90 million. The fine precipitated a change in ownership of that company and additional equity injected – the Ofwat (August ’22) consultation on the transfer that took place in 2021 is here.

(12) Mr Eustice distinguished – one matter is the failure of water companies to abide by their permit conditions, the reason for the Environment Agency bringing multiple prosecutions. Another matter is the separate issue of the permitted use of storm overflows. That issue is about long-term investment in infrastructure, which is the focus of the government’s storm overflows discharge reduction plan.

Peat Ban (England)

On 27th August 2022 the UK government announced that all sales of peat to amateur gardeners in England would be banned by 2024. The press release is here.

The press release states that “Bagged retail growing media accounts for 70% of the peat sold in the UK and is frequently misused, for example being used as a soil improver rather than a medium in which to propagate plants.”

This ban follows an extensive consultation that was held.

A ban for the professional horticulture sector will follow, but is not announced.

Natural England is working with Defra and partners on the ground to restore thousands of hectares of peatland habitats, and the press release states via round two of the Nature for Climate Fund Peatland Restoration Grant, Natural England awarded on 27th August nearly £11 million to six projects to support restoration works on over 7,000 hectares of peatland, adding to more than 8,000 hectares already funded through round one.

The press release states round two of the Restoration Grant has supported a blend of lowland and upland restoration works, with the Somerset Peatland Partnership convening to restore lowland sites in the south-west of England, and the Great North Bog and Moors for the Future partnerships restoring upland sites in the north of England.

Clean Air Zones (England)

Air quality objectives and standards in Britain follow those set by the EU (to 31st December 2020), meanwhile the WHO published new Global Air Quality Guidelines in 2021 here.

Repeated court decisions have determined breaches in Britain, and as a consequence DEFRA is obliging local authorities (England) to meet legal deadlines for improved air quality in hot spot areas. This is done via Local Air Quality Management (also an EU legacy).

Clean Air Zones are sometimes the result. In addition to the Low and Ultra Low Emission Zones in London, three Clean Air Zones are established in England. The Greater Manchester Clean Air Zone is delayed.

Information on Clean Air Zones is here. Note, there can be different types of Clean Air Zones.

Information on the London Zones is here. Note, London operates a Congestion Charge Zone, a Low Emission Zone and an Ultra Low Emission Zone.

Scotland is planning Low Emission Zones in 2022 – information is here.

Building Safety Regulator (England)

Clause 2 of the Building Safety Bill (not yet enacted), appoints the Health and Safety Executive (HSE) as the Building Safety Regulator in England.

The Building Safety Regulator will be an independent regulator with its own powers, strategic plan, and programme of work. It will give expert advice to local regulators, landlords and building owners, the construction and building design industry, and to residents.

The Bill proposes that the Building Safety Regulator will have two objectives:

(1) securing the safety of people in and around buildings in relation to risks from buildings

(2) improving building standards.

The Building Safety Regulator will:

* implement a new, more stringent regulatory regime for high-rise buildings in England (high-rise buildings are residential buildings of 7 storeys or more or 18 metres or more in height and in the design and construction phase only, including care homes and hospitals that meet the same height threshold)

* be the building control authority in England for building work on high-rise buildings

* oversee and enforce a new regime for occupation of high-rise buildings

* oversee the safety and performance of all buildings. This has two aspects:

(1) overseeing the performance of other building control bodies (local authorities and registered building control approvers (currently known as approved inspectors))

(2) understanding and advising on existing and emerging building standards and safety risks

* promote competence among industry professionals and regulators to raise standards in the design, construction, and management of buildings.

The HSE published on 14 October 2021 a fact sheet on its proposed enforcement approach – here.

This fact sheet states the HSE intends that –

* the Building Safety Regulator will deliver evidence-based, proportionate, and targeted engagement and interventions with dutyholders,

* the Building Safety Regulator’s programme of work will include communication activities to advise and support dutyholders and residents,

* enforcement activities and sanctions will be targeted to improve the safety and performance of buildings.

The Building Safety Bill provides for greater regulatory scrutiny and the HSE expects a series of hard stops at key stages during design and construction to be introduced by separate regulation (enacted under the Bill when it is an Act and commenced).

During occupation of the buildings in scope, the Bill requires dutyholders to demonstrate ongoing management of building safety risk through a safety case report. The HSE fact sheet states this will give the Building Safety Regulator a wide range of tools to achieve improved building safety performance and to deliver the culture change identified in Dame Judith Hackitt’s review Building a Safer Future.

The Building Safety Regulator will be responsible for the regulatory decisions during the design, construction, occupation and refurbishment of high-rise buildings.

Per the HSE fact sheet – the Building Safety Regulator’s activities to achieve building safety and performance outcomes will include:

* granting permission to proceed with construction work and issuing completion certificates at appropriate points in the construction and occupation phases

* a process of providing certification following assessment of the in-occupation safety case

as well as formal enforcement and sanctions.

There will be a published Enforcement Policy Statement (EPS). But it may be the HSE arrives at a position that it’s existing HSE EPS is sufficiently flexible to accommodate its new responsibilities as the Building Safety Regulator or it requires some amendment but is still the right vehicle.

Re the building safety report – the bill requires a building specific safety case report to be produced (high rise buildings in the design and construction phase). This safety case report will identify the fire and structural hazards associated with the building. It will set out how the risks they present are being managed to prevent the risks materialising and reduce the severity of any incident resulting if the risks do materialise. The adequacy of the safety case will be assessed by the Building Safety Regulator, working with multi-disciplinary teams, as part of the building assessment certification process.

Re oversight of existing building control inspection – the Building Safety Regulator will monitor the performance of local authority building control bodies and private sector building control approvers. The fact sheet states the HSE will also oversee and regulate all individuals working as building inspectors. Building inspectors and building control approvers will be subject to a registration requirement and the Building Safety Regulator may suspend or remove inspectors from the register and address performance and professional misconduct. The fact sheet states there will be improved competence and accountability through the creation of a unified professional and regulatory structure.

First Project Orbis Cancer Treatment Authorisation (UK)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has just announced its first authorisation (of a post-surgery lung cancer treatment) under Project Orbis.

Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments.

It involves the regulatory authorities of:

• Australia (TGA)

• Canada (Health Canada)

• United Kingdom (MHRA)

• Singapore (HSA)

• Switzerland (Swissmedic)

• Brazil (ANVISA)

The UK joined Project Orbis on 1 January 2021 following its departure from the EU (and the European Medicines Agency with the ending of the Brexit transition period on 31 Dec 2020). While the FDA serves as the primary coordinator for application selection and review, Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision. Applications submitted to the MHRA within a Project Orbis procedure are national (Great Britain only) marketing authorisation applications and variations.

Per the MHRA press release – Osimertinib (Tagrisso), a medicine made by AstraZeneca, is a licensed treatment for patients with mid and later stage non-small cell lung cancer (NSCLC) who test positive for a specific gene mutation called EGFR. EGFR mutations occur in approximately 12% of lung cancer patients. The licence has now been extended to include a new population of patients in early-stage disease. The extended licence offers a novel treatment option for these patients, after their cancer has been surgically removed, in an area of significant unmet need.

NHS England, NICE (the National Institute for Health and Care Excellence) and AstraZeneca have reached an agreement to enable early access to osimertinib for early-stage lung cancer patients in England on a budget-neutral basis to the NHS while NICE undertakes its appraisal.

The MHRA press release is here. The press release sets out further detail.

Please note different Medicines supply stipulations apply in Northern Ireland from 1 Jan 2021 – here.

Plastic Bag Charge (England)

The UK government has just announced that the single-use carrier bag charge will be increased from 5p to 10p and extended to all businesses in England from 21 May.

The announcement is here. The guidance was updated on 30 April here – note the exceptions.

Scotland already raised the plastic bag charge, effective from 1st April 2021. This was reported in our March Email Alert. Note, plastic bag charges are temporarily suspended (Scotland) for certain types of delivery until 31 May.

GMO Regulation Changes (England)

In its first Brexit de-regulation foray (of relevance to this blog) – the UK government today seeks views on its plans to change its regulation of genetically modified organisms (GMOs) in England – here.

The consultation ends on 17 March 2021.

Part 1 of the consultation focuses on the regulation of gene edited (GE) organisms possessing genetic changes which could anyway have been introduced by traditional breeding.

Part 2 of the consultation engages separately and starts gathering views on the wider regulatory framework governing genetically modified organisms (GMOs).

Depending on the results of part 1, DEFRA may change the legislation to amend the definition of a GMO as it applies in England. Currently GMOs are defined in section 106 of the Environmental Protection Act 1990 (amended by the GMO Deliberate Release Regulations). This would mean that the law would not apply to organisms produced by gene editing (GE) and other genetic technologies if they could have been developed using traditional breeding methods. DEFRA’s view is that organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods.

The responses from part 2 of the consultation will be used by the UK government to inform policy development and stakeholder engagement plans on any potential wider GMO reform.

On 25 July 2018 the Court of Justice of the European Union (CJEU) clarified that organisms obtained by mutagenesis are genetically modified organisms (GMOs) as defined in the European Directive 18/2001/EC. The journal Nature has a useful summary article on this technical field – here.

Note – the Court also clarified that organisms obtained by mutagenesis techniques which have conventionally been used in a number of applications and have a long safety record are exempt from those obligations, on the understanding that the Member States are free to subject them, in compliance with EU law, to the obligations laid down by the directive or to other obligations.

The ECJ Press Release on the matter is here.

F-Gases and ODS (GB from 1st Jan 2021)

I posted a few days ago with the stipulations if exports to the EU are rejected. Today, 15th Oct, DEFRA and the Environment Agency issued full instructions on the regulations that will apply in England, Scotland and Wales (Great Britain – GB), for F-Gases and ODS from 1st Jan 2021.

The updated webpage is here.

GB will continue to:

• restrict ODS

• use the same schedule as the EU to phase down HFCs (hydrofluorocarbons, the most common type of F gas) by 79% by 2030 relative to a 2009 to 2012 baseline

That means new GB F gas quotas will follow the same phase down steps as the EU:

• limited to 63% of the baseline in 2019 and 2020

• reducing to 45% of the baseline in 2021

Most of the rules for F gas and ODS will not change. However, new GB IT systems will need to be used to:

• manage new GB quotas

• report on use

EU regulations will still apply for F gas, ODS and products containing them placed on the EU and Northern Ireland market after 1 January 2021.

The Environment Agency will administer the GB system on behalf of England, Scotland and Wales, if it receives the direction of the Scottish and Welsh Governments, from 1 January 2021.

Businesses preparing for 1 January 2021 should continue to work with the Environment Agency to register on the GB system and apply for GB quotas.

Please read the entire webpage, as the above is only part of the stipulations.