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.

Industrial Emissions (BAT) (GB from 1st Jan 2021)

Yesterday, 14 Oct, the UK government issued a short guidance note on EU BAT (Best Available Techniques) from 1st Jan 2021 – here.

This confirms the UK will no longer be part of the EU-Sevilla BATC (binding BAT Conclusions) document production process from 1st Jan 2021.

The UK government note states

it would make secondary legislation to ensure the existing BAT Conclusions continue to have effect in UK law after we leave the EU, to provide powers to adopt future BAT Conclusions in the UK and ensure the devolved administrations maintain powers to determine BAT through their regulatory regimes.

The UK government will put in place a process for determining future UK BAT Conclusions for industrial emissions. This would be developed with the devolved administrations and competent authorities across the UK. The UK government’s Clean Air Strategy for England sets out actions for determining future UK Best Available Techniques for industrial emissions.

The note makes no mention of Northern Ireland, where via the Withdrawal Agreement Ireland/Northern Ireland Protocol, the EU Industrial Emissions Directive, and the EU BATC process would stay applicable in Northern Ireland.

COVID-19 Workplace Guidance (England)

Yesterday (25 May) saw the key Working Safely guidance for different workplaces (issued 11 May) updated to reflect industry feedback and to expand coverage of non essential retail categories ahead of planned opening.

On the 19 May, the 5 steps for businesses to take were added – here. Please note (as I posted before, check back on my Blog, the risk assessments of larger businesses must be published on their websites).

You should share the results of your risk assessment with your employees. If possible, you should consider publishing it on your website (and we would expect all businesses with over 50 employees to do so).

Notice that should be displayed in the workplace – here.

The Working Safely Guidance link is here.

Please note the links to the guidance issued in Scotland, Wales and Northern Ireland, where the timetable of non-essential business re-opening differs.

Non-essential retail in England will re-open in June, as set out in the PM timeline issued yesterday 25 May –

• Outdoor markets and car showrooms will be able to reopen from 1 June, as soon as they are able to meet the COVID-19 secure guidelines to protect shoppers and workers. As with garden centres, the risk of transmission of the virus is lower in these outdoor and more open spaces. Car showrooms often have significant outdoor space and it is generally easier to apply social distancing.

• All other non-essential retail including shops selling clothes, shoes, toys, furniture, books, and electronics, plus tailors, auction houses, photography studios, and indoor markets, will be expected to be able to reopen from 15 June if the Government’s five tests are met and they follow the COVID-19 secure guidelines, giving them three weeks to prepare.

Certain businesses and activities must remain closed – see here. This is underpinned by enacted law.