River Basin Management (Ireland)

The Department of Housing, Planning and Local Government has published the (second) River Basin Management Plan 2018-2021 for Ireland. An earlier RBMP had been published. This second RBMP plans on the basis that Ireland is defined as a single River Basin District – the Ireland RBD (NOT including Northern Ireland). The areas bordering Northern Ireland are included in two other River Basin Districts – the North Western RBD and the Neagh Bann RBD that are run from Northern Ireland (part of the UK, a separate country and currently exiting the EU).

The River Basin Management Plan for Ireland 2018-2021 is here.

[The Neagh Bann River Basin Management Plan 2015-2021 is here.]

[The North Western River Basin Management Plan 2015-2021 is here.]

RBMPs set out the actions that an EU member state will take to improve water quality and achieve ‘good’ ecological status in water bodies (rivers, lakes, estuaries and coastal waters) by 2027. EU member states are required to produce river basin management plans under the EU Water Framework Directive (WFD).

BREXIT : it is not yet clear how River Basin Management planning will occur in the UK going forward. I will issue a separate Blog on this, when there is further information.

Water quality in Ireland has deteriorated over the past two decades. This second RBMP provides a more coordinated framework for improving the quality of waters — to protect public health, the environment, water amenities and to sustain water-intensive industries, including agri-food and tourism, particularly in rural Ireland.

The Irish River Basin District (RBD) covers an area of 70,273km2, with 46 catchment management units — consisting of 583 sub-catchments, with 4,829 water bodies. With regard to protected areas within the District, there are 140 designated bathing waters, 64 shell fish waters, 47 nutrient sensitive areas and 358 special areas of conservation (SACs) with water dependency. These SACs are geographically concentrated along the western seaboard – with a significant overlap between high-status waters and SACs. The RBD has a population of around 4.76 million, with 33% of people living in cities, 29% in towns and 38% in rural areas. The requirement for water and waste-water services reflects these spatial patterns. Nationally, the economy is strongly export-focused, but the sectoral drivers of economic growth across the RBD are diverse – with the agriculture and food sectors being particularly important in rural areas.

Key measures during the first RBMP included the licensing of urban waste-water discharges (with an associated investment in urban waste-water treatment) and the implementation of the Nitrates Action Programme (Good Agricultural Practice Regulations). The urban waste-water licensing made significant progress in terms both of compliance levels and of the impact of urban waste-water on water quality. The Nitrates Action Programme created an environmental baseline which all Irish farmers must achieve and has resulted in improving trends in the level of nitrates and phosphates in rivers and groundwater.

This second RBMP will establish :

(1) an Agricultural Sustainability Support and Advisory Programme to be implemented by 30 new Advisors — funded by Department of Housing, Planning and Local Government (DHPLG), Department of Agriculture, Food and the Marine (DAFM) and the dairy co- ops — who will work under Teagasc and the dairy co-ops. The Advisors will work on a one-to-one basis with farmers to bring about behavioural change through improved agricultural practices in areas which have identified pressures on water bodies.

(2) Local Authority Support and Advisory Teams to carry out scientific assessments and to drive the implementation of mitigation measures at local level. Recruitment of investigative assessment personnel commenced in Quarter 1 2018 and provision has been made for up to 43 specialist staff to be in place by mid-2018. These resources will be assigned across the five regions.

(3) Agri-environment schemes implemented through the Rural Development Programme (RDP) to lead to investment in manure storage and improved nutrient utilisation. In particular, the targeted approach to the Green, Low-Carbon, Agri- Environment Scheme (GLAS), which has 50,000 participants, is intended to ensure appropriate supporting measures on farms to protect and improve water quality.

(4) improved compliance with the existing Good Agriculture Practice Regulations through implementation of the enhanced Nitrates Action Programme (NAP) for 2018–2021 and of the associated inspection regime. The Programme entails new strengthened water- protection measures, focused on intercepting and breaking nutrient transport pathways and on preventing sediment and nutrient losses to waters.

(5) a National Inspection Plan 2018–21 for domestic waste-water treatment systems, currently being finalised by the EPA – this will use the outputs of the catchment characterisation work to further improve the risk-based approach to inspection of septic tanks. It is expected that approximately 1,000 inspections will be carried out by local authorities nationally each year.

(6) significant planned investment in urban waste-water collection and treatment infrastructure. Over the period 2017–2021, the plan is for Irish Water to invest approximately €1.7 billion in waste-water projects, programmes and asset maintenance.

(7) a register of water abstractions (held by the DPHLG), who will consult on a proportionate and risk-based framework for the regulation of abstractions to ensure continued sustainable use of our water resources. The EPA will continue work on assessing risk due to abstractions, making use of new information as it emerges during the second cycle.

Indicative Occupational Exposure Limits (EU)

Directive 2017/164/EU – indicative occupational exposure limit values of 31 January 2017 establishing a fourth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directives 91/322/EEC, 2000/39/EC and 2009/161/EU (Text with EEA relevance) – is in force.

The Cardinal Environment EHS Legislation Registers and Law Checklists have the third list of indicative occupational exposure limit values. The fourth list is being added shortly.

The fourth list is based on Council Directive 98/24/EC concerning the protection of the health and safety of workers from the risks related to chemical agents in the workplace. This was the case for previous indicative lists.

Indicative occupational exposure limit values (IOELV) are health-based, non-binding values, derived from the most recent scientific data available and taking into account the availability of reliable measurement techniques.

For any chemical agent for which an IOELV has been set at European Union level, Member States are required to establish a national occupational exposure limit value. They also are required to take into account the European Union limit value, determining the nature of the national limit value in accordance with national legislation and practice.

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 August 2018 at the latest.

Regarding the limit values for nitrogen monoxide, nitrogen dioxide and carbon monoxide, Member States will be able to benefit from a transitional period ending at the latest on 21 August 2023.

The 2017 Directive establishes limit values for the following chemical agents:

Manganese and inorganic manganese compounds (as manganese)

Glycerol trinitrate

Carbon tetrachloride; Tetrachloromethane

Amitrole

Acetic acid

Hydrogen cyanide (as cyanide)

Methylene chloride; Dichloromethane

Vinylidene chloride; 1,1-Dichloroethylene

Tetraethyl orthosilicate

Acrylic acid; Prop-2-enoic acid

Nitroethane

Bisphenol A; 4,4′-Isopropylidenediphenol

Diphenyl ether

2-ethylhexan-1-ol

1,4-Dichlorobenzene; p-Dichlorobenzene

Acrolein; Acrylaldehyde; Prop-2-enal

Methyl formate

But-2-yne-1,4-diol

Tetrachloroethylene

Ethyl acetate

Sodium cyanide (as cyanide)

Potassium cyanide (as cyanide)

Diacetyl; Butanedione

Carbon monoxide

Calcium dihydroxide

Calcium oxide

Sulphur dioxide

Lithium hydride

Nitrogen monoxide

Nitrogen dioxide

Terphenyl, hydrogenated

Skin absorption feature of ten substances is noted.

Of the 33 substances above, 4 were already listed in the Annex to Commission Directive 91/322/EEC, one was listed in the Annex to Commission Directive 2000/39/EC and one in the Annex to Commission Directive 2009/161/EU. The establishment of new indicative limit values was recommended by SCOEL for the above six substances listed in the Annex to this Directive. They will be deleted from the Annexes to the previous directives on 21 August 2018.

The further lists on indicative occupational exposure limit values (in Cardinal Environment EHS Legislation Registers and Law Checklists):

• Commission Directive 91/322/EEC establishing indicative limit values

• Commission Directive 2000/39/EC establishing a first list of indicative occupational exposure limit values

• Commission Directive 2006/15/EC establishing a second list of indicative occupational exposure limit values

• Commission Directive 2009/161/EU establishing a third list of indicative occupational exposure limit values

UK – the EH40 list is reissued – here (and will be added shortly to Registers and Law Checklists)

Ditto the Ireland list is updated, and Continental European Registers and Law Checklists will have their current lists updated.

Technical Notices (UK Brexit Preparedness)

UPDATE : government letter to the health care sector (this calls for stockpiling to ensure continuity of supply) – here.

The UK government has today issued its first tranche of Technical Notices in the subject area of UK Brexit Preparedness. These Technical Notices create requirements for Government to have online portals and other IT in place, and for stakeholders to use these, and make other arrangements.

The Technical Notices are here.

Please read the Notices carefully, any questions, please email them directly to me.

Energy Sector (UK Brexit Preparedness)

As with the Financial Sector, the UK government has advised it will issue Regulations to ‘onshore’ energy legislation. This communication is here.

Unless the forthcoming changes to energy legislation relate to the Climate Change Levy or other climate related areas, this Blog post will be the only Blog post I will write about the matter.

Standard Rules Environmental Permitting (England)

The Environment Agency offers standard rules environmental permits in England for listed activities.

Further permits are now available (waste).

The full list is here.

Note : standard rules permits are cheaper, but

• the rules cannot be varied and there is no right of appeal against them

• any change in operations so a standard permit no longer works for the operation results in a requirement to make it a bespoke permit instead

• if there is a change in the local environment after the permit has been issued (for example due to a change in the definition of a groundwater source protection zone), the operation may need to be upgraded to a standard sufficient for the changed environment, or the permit changed to a bespoke permit

Plastics Update (UK)

The UK Government has been consulting on “the plastics problem”. This consultation has just concluded. The document is here (it is mostly the consultation responses) :

The government response is (stated in the document) :

(1) The government is developing a new strategy on resources and waste that looks ahead at opportunities outside the EU. This will set out the detail of how the government will meet the ambitions for resources and waste that are set out in the Clean Growth Strategy, the Industrial Strategy and the 25 Year Environment Plan.

(2) The aim of the strategy will be to make the UK “a world leader in resource efficiency and resource productivity”, and “increase competitiveness”. It will set out how the government will work towards ambitions of doubling resource productivity and zero avoidable waste by 2050, maximising the value extracted from resources and minimising waste and the associated negative environmental impacts.

(3) The strategy will be published this year, as will a consultation on the reform of the packaging waste regulations and a deposit return scheme for beverage containers.

Please note : household waste recycling is already adrift of the 2020 recycling targets, and I posted earlier about the EU waste law changes (enacted, changing existing EU waste directives, including the packaging and packaging waste directive, with forward dates – the EU Combined Cycle law) that increase recycling targets further.

Carriage of Dangerous Goods (UK Brexit Preparedness)

The UK government is now consulting on new 2018 CDG Regulations (applicable in Britain) that will be brought forward to amend the CDG 2009 (the 2009 dated CDG Regulations that were amended in 2011) : the document is here

(separate amending regulations will be brought forward in Northern Ireland)

(1) to remove deficiencies arising from the UK’s exit from the European Union (EU), including textual amendments to definitions and requirements that are currently predicated on the UK being a Member State of the EU. The In-force day is the day that the UK exits the EU (“exit day”).

The amendments will maintain the dangerous goods regulatory framework and the international process behind it as it is today, including the GB Competent Authority’s power to grant authorisations and implement derogations. Those involved in the carriage of dangerous goods will continue to be required to follow the requirements of RID (for rail) and ADR (for road), in the same way as before EU exit.

The amendments are purely technical. They primarily amend definitions and requirements that are currently predicated on the UK being a Member State of the EU. For example, references to the UK being a “relevant Member State” are replaced with references to “relevant territory”. Textual amendments to CDG 2009 also make it clear that references to ADR and RID will continue to be to the latest versions of those documents, whereas references to the DG Directive and the Transportable Pressure Equipment Directive (2010/35/EU) will be to the versions of those Directives in force upon exit day. These new regulations will be cited as the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) (EU Exit) Regulations 2018.

(2) to gather input for future changes – flexibility will continue on how dangerous goods regulation is implemented in the future, the UK government is seeking input on this.

In addition, the legal requirement for vapour recovery systems to be installed on mobile tanks is reinstated.

The Petroleum (Consolidation) Regulations 2014 mistakenly revoked regulation 5 of the Carriage of Dangerous Goods by Road Regulations 1996 in its entirety. This regulation referenced, amongst other documents, the Approved Tank Requirements published by the Health and Safety Commission. These included the requirements for the design and construction of tanks in respect of the control of volatile organic compound (VOC) emissions. Whilst the references to other documents were no longer required, the reference to the Approved Tank Requirements was.

This mistake is being rectified in a separate Statutory Instrument by the Department for Business, Energy & Industrial Strategy. It is entitled [Radioactive Substances], [Transport] of Radioactive Material (Radiation Emergencies) Regulations 2018. Those Regulations will contain a reference to the Approved Tank Requirements concerning the provisions for vapour recovery systems of mobile containers carrying petrol.

Domestic Burning (UK)

The UK government is consulting now on new controls to be brought in on wood and coal burning in domestic scale appliances and fireplaces.

The consultation asks for input on a range of questions, and states that new UK law will be brought in to restrict the sale of coal and wet wood.

This consultation is here.

This follows in from new voluntary guidance issued to farmers and agricultural contractors re ammonia emissions. This guidance is here.

Financial Sector (UK Brexit Preparedness)

Recently the UK updated its approach to ‘onshoring’ financial services and the guidance is here.

The necessary legislation (as statutory instruments) is now being drafted. There will be considerable numbers of these instruments.

Since financial services are not my area, I do not propose to Blog post further about these. So this Blog post is the only post I will write on this topic.

Financial services underpin a very wide range of ordinary daily commercial and domestic activities, such as for example the deposit guarantee scheme guarantees bank deposits. My suggestion is the reader finds someone who is tracking this subject and follow them also.

Life Science Sector (UK Brexit Preparedness)

UPDATE : further information on the Clinical Trials Regulation (issued 6th August) is here.

Today (6th August) the Department of Health & Social Care, the Medicines & Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, together, issued Guidance.

The guidance is “What the implementation period means for the life science sector’. This document is here. NB – the implementation period is the UK term for the EU transition period.

The guidance states (and note, this is subject to EU-UK agreement of the Withdrawal Agreement) :

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

The document also states the UK reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach.

This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

A vital issue is EU legislation enacted during this implementation/transition period, or enacted beforehand with forward enforcement dates in the period, or enacted after the period – below is illustrative (from this document, and applicable to this subject)

(1) The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.

Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

(2) The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

(3) The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)