Nuclear Safety Standards (Euratom/EU)

I blog posted recently about the UK Nuclear Safeguards Bill (a UK Brexit Bill). This Bill does not cover radiation health rules (which are also regulated by EU/Euratom). 

The Euratom/European Union Basic Safety Standards Directive 2013 (BSSD) sets out updated safety requirements for the nuclear and radiological sector; the deadline for transposition of these into UK law is 6 February 2018

The BSSD 2013 updates the 1996 BSSD that is included in subscribers’ Cardinal Environment OHS Register 601. It simplifies existing Euratom provisions for protection against harmful effects of ionising radiation, and consolidates those provisions in line with the latest international standards.

The UK Department for Business, Energy and Industrial Strategy (BEIS) is responsible for coordinating the transposition of the Directive across Government, there are five workstreams to the Directive: emergency preparedness and response, medical exposures, public exposures, occupational exposures, and air and space crew where compliance is necessary.

The emergency response and public exposures requirements of BSSD are led by BEIS and occupational exposure requirements are led by the Health and Safety Executive (HSE).

The intention is to use the powers in the Health and Safety at Work Act and the Energy Act 2012 to make the required legislative changes within the Radiation (Emergency Preparedness and Public Information) Regulations (REPPIR) 2001 and the Carriage of Dangerous Goods Regulations (CDG) 2009 and the Ionising Radiation Regulations 1999 (IRR99).

HSE has now consulted on occupational exposures policy and are finalising the proposed changes to the IRRs (this document is here); BEIS has launched a consultation on emergency preparedness and response policy with suggested changes to REPPIR & CDG (see here). BEIS is also planning to launch a consultation on the public exposures elements of the Directive.

The other workstreams are led by different Government departments, with medical exposures being led by the Department for Health and air and space crew by the Department for Transport.

Re Brexit : it is presumed these rules will be dealt with under the EU Withdrawal Bill (a key UK Brexit Bill), once it is enacted, since they are not dealt with under the Nuclear Safeguards Bill. 

Subscribers to Cardinal EHS Legislation Registers will see Email Alerts re the changes to the CDG and IRR99. 

Nuclear Safeguards Bill (UK)

The Nuclear Safeguards Bill was given its First Reading on 11th October, and its Second Reading (a debate stage) will take place on Monday. This Bill is found here

[please note, amendments could be made to this Bill, most notably to the way in which regulations will be enacted]

When enacted, it will :

(1) put in place the legal framework for a nuclear safeguards regime to operate in the UK. This domestic regime will replace the current legal framework provided principally by the UK’s membership of the European Atomic Energy Community (“Euratom”). Nuclear safeguards arrangements enable the UK to meet international nuclear safeguards standards and engage in certain international civil nuclear activities, including trade and research and development.

Nuclear safeguards primarily involve reporting and verification processes by which the UK demonstrates to the international community that civil nuclear material is not diverted into military or weapons programmes. Nuclear safeguard procedures can include accountancy and reporting on civil nuclear material holdings and development plans, verification (including inspections of nuclear facilities by international inspectors), containment measures and surveillance (including cameras in selected facilities). Nuclear safeguards are distinct from nuclear safety (the prevention of nuclear accidents) and nuclear security (physical protection measures), which are the subject of independent regulatory provisions.

(2) amend the Energy Act 2013 to replace the existing nuclear safeguards purposes of the Office of Nuclear Regulation (“ONR”). The ONR is the UK’s nuclear regulator. The ONR has five purposes which define its areas of responsibility and where it will be able to exercise functions. Currently, the nuclear safeguards purposes of the ONR is defined by reference to Euratom and existing agreements with the International Atomic Energy Agency (“IAEA”) (which also depend on membership of Euratom). The new nuclear safeguards purposes of the ONR will require it to ensure compliance with regulations on nuclear safeguards made by the Secretary of State and to ensure compliance of the United Kingdom with international agreements relating to nuclear safeguards.

(3) provide powers to the Secretary of State to make nuclear safeguards regulations, which will set out the detail of the domestic regime for nuclear safeguards. The regulation‐making power can also be used to implement the new international agreements the United Kingdom envisages concluding (for example, with the IAEA).

(4) provide a regulation‐making power to the Secretary of State to amend certain legislation (including primary legislation) which make reference to parts of existing agreements on nuclear safeguards between the IAEA and the United Kingdom. These references will need to be updated when the existing agreements with the IAEA are replaced with new ones (which are currently being negotiated).

NOTE

Following its notification to the European Commission, the Government set out its intention to legislate to put in place a domestic safeguards regime operated by the existing nuclear regulator, the ONR. The ONR currently performs inspections on United Kingdom nuclear facilities for a range of purposes safety and security (and it has a complementary role supporting Euratom’s and the IAEA’s work in respect of nuclear safeguards).

The new domestic safeguards regime will replace the current regime operated by Euratom that will cease to have effect in the UK in 2019. The Queen’s Speech on 21 June 2017 included a Nuclear Safeguards Bill. 

The detail of the current European safeguards regime is set out in Commission Regulation (Euratom) No. 302/2005 of 8 February 2005 on the application of Euratom safeguards (“the Euratom Regulation”), made under the Euratom Treaty. The Euratom Regulation imposes the detailed technical requirements on those holding civil nuclear material and takes effect automatically in United Kingdom law by virtue of the European Communities Act 1972 (without specific domestic implementing legislation).

The Energy Act 2013 established the ONR as the United Kingdom’s independent nuclear regulatory body in 2014 (with certain functions having rested with the Health and Safety Executive). The Energy Act 2013 currently sets out the purposes of the ONR, which define the five areas of regulatory responsibility: those relating to nuclear safety, nuclear health and safety, nuclear security, nuclear safeguards, and transport of radioactive material. In addition to this section 74 of the Energy Act 2013 provides for the Secretary of State to make regulations (known as “nuclear regulations”) for four of the ONR’s purposes, including the nuclear safeguards purposes.

Under section 72 of the Energy Act 2013 the “nuclear safeguards purposes” means the purposes of (a) ensuring compliance by the United Kingdom with the safeguards obligations and (b) the development of any future safeguards obligations. “The safeguards obligations” is then defined by section 93(2) of the Energy Act 2013 by reference to the European Euratom system. 

As a result, the UK’s safeguards regime generally, and the ONR’s nuclear safeguards purposes specifically, are fundamentally underpinned by the United Kingdom’s membership of Euratom. Euratom is a party to the United Kingdom’s two main agreements with the IAEA (and many of the United Kingdom’s obligations to the IAEA are discharged by virtue of membership of Euratom). As such, the United Kingdom existing nuclear safeguards regime will become ineffective on the United Kingdom’s withdrawal from the Euratom Treaty.

This Bill confers a regulation‐making power which will enable the Secretary of State to put in place the detailed requirements that are necessary for a nuclear safeguards regime, including by imposing obligations on those who hold nuclear materials. The regulation‐making power can be used to implement the new international agreements the UK envisages concluding (for example, with the IAEA). The power can also be used to impose domestic standards.

The ONR’s nuclear safeguards purposes are amended to reflect the fact that the obligations it will be responsible for ensuring compliance with will be contained within domestic regulations and new international agreements (rather than the Euratom Regulation). The ONR, rather than the European Commission, will become the regulator.

The nature of safeguards regimes is such that the substantive provisions are detailed and technical in nature. This will be the case for the domestic safeguards regime put in place under the powers in the Bill. The majority of this detail will be laid out in regulations which will, on first use, be subject to the affirmative resolution procedure. These regulations will place obligations on those responsible for “qualifying nuclear material”, “qualifying nuclear facilities” and “qualifying nuclear equipment”, including in respect of: record‐keeping and accounting, the provision of information, inspection and monitoring, imports and exports, the design of qualifying nuclear facilities or equipment and the production, processing, use, handling , storage or disposal of qualifying nuclear material or equipment.

In addition to the provisions of the Energy Act 2013 there are additional pieces of legislation (i.e. the Nuclear Safeguards and Electricity (Finance) Act 1978, the Nuclear Safeguards Act 2000 and the Nuclear Safeguards (Notification) Regulations 2004) that implement the United Kingdom’s existing nuclear safeguards obligations. These will not operate properly after the United Kingdom’s withdrawal from Euratom due to their detailed references to provisions of the United Kingdom’s existing nuclear safeguards agreements with the IAEA. The consequential amendments necessary to these pieces of legislation will depend on new safeguards agreements between the United Kingdom and the IAEA that are currently being negotiated; as such the United Kingdom will need to maintain flexibility to ensure these future agreements can be implemented in domestic legislation. A power to allow this legislation to be amended in this way is taken in clause 2 of the Bill.

MONEY

Establishing and operating the new regime by the ONR in line with the regulations that will be made under the powers in the Bill will require public expenditure. The costs to set up a UK domestic safeguards regime (which are not finalised) are potentially up to £10m. This would include procurement of a new IT system, recruitment and training of a large number of inspectors and strengthening institutional capacity to deliver the project. This cost can be met from within BEIS’s Spending Review allocations. The cost of any equipment currently in the UK but belonging to Euratom is a matter currently under negotiation with the European Union. The regime is also likely to involve an ongoing cost of around £10m a year, which is in line with the UK’s current cost of Euratom safeguards activity in the United Kingdom.

Cardinal Environment EHS Legislation Registers contain the Euratom rules on radiation health impacts in OHS Register 601 – this Bill will be added the Brexit Law List that subscribers will begin to notice added to their systems shortly. Earlier Blog posts refer to this Cardinal Brexit Law List. 

UPDATE : see related Blog post in Nuclear Safety Standards (Euratom/EU)

UK exits the EU (Notices to Business Operators)

I posted earlier re Medicines. The European Commission has now issued Notices to Business Operators in the following areas :

(1) GMOs – the Notice is here (this post will be updated when the Q&A is available). 

(2) Biocides – the Notice is here and the Q&A is here

(3) Pesticides and Plant Protection Products – the Notice is here and the Q&A is here.

Please pay close attention as the requirements differ with each legal instrument (topic). 

European Union (Withdrawal) Bill (UK)

Today the European Union (Withdrawal) Bill was given its First Reading in the House of Commons. The purpose of this Bill (when enacted) is to repeal the European Communities Act 1972 (ECA) on the day the UK leaves the European Union (scheduled to be 29th March 2019). 

The principal purpose of the Bill is to provide a functioning statute book on the day the UK leaves the EU. As a general rule, the same rules and laws will apply on the day after exit as on the day before. It will then be for Parliament and, where appropriate, the devolved legislatures to make any future changes.

The Bill performs four main functions. It:

(1) repeals the ECA;

(2) converts EU law as it stands at the moment of exit into domestic law before the UK leaves the EU;

(3) creates powers to make secondary legislation, including temporary powers to enable corrections to be made to the laws that would otherwise no longer operate appropriately once the UK has left the EU and to implement a withdrawal agreement; and 

(4) maintains the current scope of devolved decision making powers in areas currently governed by EU law.

Subscribers to Cardinal Environment Limited Tailored EHS Legislation Registers and Law Checklists for the UK, and the regional variants, England, Wales, Scotland, Northern Ireland, and Britain, and England &a Wales, will be substantively affected by the law changes created by this Bill and other Brexit UK laws. 

To assist the transition, we will add an additional direct linking webpage to both the Health and Safety, and the Environmental Registers access. This page will give direct access to the Brexit laws, and their explanatory notes. Please keep following this bLog for updates.

The European Union (Withdrawal) Bill is found here. The Explanatory Notes are here

UK exits the EU (3rd country status)

UPDATE : the EU position paper dated 20th September 2017 sets out the current position – this document is here.

In a speech this morning Michel Barnier set out the implications for customs and rules of origin checks to operate from 30 March 2019 00:00h CET (when the UK is a third country as respects trade with the EU).
This post is updated with a link to the EU position paper of 20th September. The images are screen grabs of the tweets of BBC correspondent Damian Grammaticas who attended the speech. 

Note: this information could alter if transitional arrangements are agreed, or indeed if a EU-UK trade agreement materialises.

Note: this Blog has an environment and health and safety focus, please refer elsewhere for more detailed information on third country customs and single market trading rules.

UK exits the EU (medicines and veterinary products)

On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.

The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :

(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),

(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,

(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,

(4) active substances manufactured in the UK will be considered imported active substances, 

(5) medicinal products manufactured in the UK will be considered imported medicinal products, 

(6) batch release sites (for certification) must be located in the EEA. 

UK exits EU next steps (UK & EU)

The UK has 10 days before it’s population decides the next government on 8 June. On 19 June, negotiations begin to settle the terms for the UK’s withdrawal from the EU. 

The EU has committed itself to transparency principles here

Information about the EU task force that is involved is located here.

Cardinal Environment Limited will continue to support its customers through this process. The law of individual EU and EEA member states is not affected.