Environmental Law News Update

In this latest Environmental Law News Update, Christopher Badger considers Environment Agency plans to update the OPRA scheme, a new chemical regulation report, and the European Commission’s new Roadmap on pharmaceutical regulation.

Environment Agency to update OPRA scheme

The Environment Agency has announced that it is replacing the Operator Risk Appraisal (OPRA) scheme for sites operating under the Environmental Permitting Regulations. It intends to replace the A-F compliance bands with four descriptive bands: Exemplary, Expected, Improvement Needed and Significant Improvement Needed. As a result, it has launched an informal consultation, with a formal consultation to follow in July.

The consultation states that the Environment Agency wishes to move to a performance based approach that would allow them “to take into account likelihood (operator responsiveness and attitude) as well as hazard and evolving market or incentive based regulatory approaches”.

This is a move towards including wider benchmarks under the heading “performance” with the intention of identifying at an early stage increasing risk. The informal consultation identifies proposed criteria for each descriptive band under a number of separate categories, although the weight to be given to any individual criteria, category or how a weighting exercise will be carried out is as yet unclear.

The consequences of poor performance are set out in the introduction:

“if an operator displays unresponsive, obstructive, abusive or hostile behaviour, such as poor complaint handling, unsatisfactory community engagement or unwillingness to comply, then this would lead to the site being in one of the two Improvement Needed bands. A site in an improvement band could expect to be the focus of our regulatory effort; in many cases we will take enforcement or remediation action to reduce unacceptable risks and as a consequence the operator will pay increased fees.”

The informal consultation can be found here

Environmental Audit Committee publishes chemical regulation report

On 29 April 2017 the Environmental Audit Committee published a report into the future of chemicals regulation after the EU Referendum. The key findings are:

• The chemicals regulation framework established through REACH would be difficult to transpose directly into UK law;
• Companies face significant uncertainty over the validity of the current REACH registrations after the UK leaves the EU: the Government must clarify the position on the future of the regulatory framework as a matter of urgency;
• In deciding the future of the UK’s relationship with the EU’s single market for chemicals, the Government should take a pragmatic approach. The most important element of REACH, which the Government should seek to remain involved in as a minimum, is the registration process for chemicals;
• Establishing a fully stand-alone system of chemicals regulation for the UK is likely to be expensive for both the taxpayer and for industry;
• The experiences of the US as it introduces an improved system of chemicals regulation could be useful for the Government when planning the UK’s approach.

The findings of the report reflect many of the concerns about environmental regulation following Brexit. Uncertainty caused by a lack of clear direction about the future of the environmental regulatory framework will prove costly to business and the resultant ‘legislative gaps’ risk environmental protection as well as fuelling legal disputes.

The report can be found here

European Commission Roadmap on pharmaceutical regulation

Pharmaceutical regulation is back on the agenda for the European Commission. Risks to the environment can result from the manufacture, use and disposal of active pharmaceutical ingredients, but this is one area where it can be argued that there has been a lack of regulation. Expect a public consultation later this year.

The short Roadmap can be found here

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