Dara Calleary (Mayo, Fianna Fail)

I thank the Deputies for their contributions. This Bill does not impose any additional obligations on industry. The regulatory impact assessment which was prepared for the 2008 Act included the CLP regulation, which was a draft EU regulation at that stage. It was not adopted in time for full inclusion in the Act but we included the provisions and obligations of the CLP in the regulatory impact assessment at that time. The regulatory impact assessment clearly showed that the regulatory framework under the Chemicals Act was the most cost effective available to us.

The rules we are applying apply to all operators in every member state of the EU. I am holding a copy of the official journal of what we are trying to implement in this legislation. It contains all the rules, regulations, appendices and everything that goes with this legislation. It is similar in size to the telephone directory we had fadó fadó of all telephone numbers outside Dublin. This is what we are trying to implement, and we are trying to do so in a way that minimises the burden on industry, as we did in 2008.

There is no need for extra resources for the HSA or the EPA as a result of this. Under the 2008 legislation, 38 inspectors were assigned to the HSA to deal with this. It is interesting to reflect on the general approach of the HSA. It is generally not enforcement but encouragement, specifically with regard to this legislation and compliance with the 2008 Act. In 2008, the HSA conducted 1,480 inspections under the Act and to date this year it has conducted 1,104. With regard to the items inspected, on the first visit compliance with the various regulations under the 2008 Act ranged from 36% to 48%. However, following advice and encouragement from the HSA, compliance on second visits was reported in all but 1% of those who received such advice. The HSA approach is to be helpful and to try to encourage rather than to enforce. That is the approach it adopts across all of its remit.

I noted the concerns about medical devices and the chemical industry generally. We all support the role of the medical device and chemical industries so I will follow up on the concerns. It is important to note, however, that the difficulties Deputy Penrose has encountered have not necessarily stopped the expansion of the medical device or chemical industries. Indeed, there was a very good announcement in my home town yesterday of 250 extra jobs as a result of a product designed in Ballina-----

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