Dara Calleary (Mayo, Fianna Fail)

-----regardless of whatever impediments the Deputy suggests were put in place. However, I will convey his remarks to the Minister.

With regard to Deputy Bruton's worry about compliance in the Department, we are absolutely committed to reducing the regulatory burden on business by 25% by 2012. It is difficult in many areas to strike a balance - one is dealing with people's lives and daily working conditions - but it is something we are committed to doing. We will be bringing forward the strategy statement. I agree with the Deputy on streamlining procedures and processes. The pharmaceutical industry's clinical trials and obligations are requirements of the Irish Medicines Board and the European medicines agencies. They are specifically excluded from this legislation but I will convey the Deputy's remarks on the matter.

As regards research in the chemical sector, the REACH regulation recognises that research should not be hampered by the rules applicable to chemicals that are already on the market. There is a provision in Article 9 of the REACH legislation for exemption from the general obligation to register for product and process orientated research and development. That is aimed to stimulate research and development, particularly in the chemical industry.

Deputies Penrose and O'Donnell expressed concerns about regulations instead of primary legislation. Any proposed regulations will be placed before the House. I agree there is a necessity to bring more power back to this House. The Office of the Attorney General has drafted the specific provision in such a way as to respect the policy and principles that apply to this legislation particularly. Any regulations that are changed will be brought before the House and will be subject to consultation.

Deputy O'Donnell made a point about competent authorities. The reason we specifically mentioned the Department of Agriculture, Fisheries and Food, the Department of Health and Children and the HSA is that they are the agencies with specific remits and expertise to carry out any additional work. That reflects the reality of cross-cutting policies. There are a number of Departments with responsibility in this regard. We have, however, given the HSA the responsibility of being the lead agency and it is has engaged in a detailed process of engagement across a large number of sectors since the implementation of the 2008 Act.

Deputy Penrose referred to the 2008 Act. It might be useful to inform the House on the current position since the implementation of that Act. The HSA has recruited 33 staff with a range of very scarce technical expertise, including some of the skills mentioned by Deputy Michael Ahern. That team has been involved in helping Irish industry to meet the demands of the new framework as well as setting up the inspection and monitoring regime that is required by the framework. The chemicals operation has won widespread respect from industry for the manner in which it has implemented these regulations and co-operated with industry. Since 2008, over 97,000 substances have been pre-registered for REACH by over 3,200 legal entities. That is actually only 240 companies, so the impact is not as wide as people might suggest.

Chemical related activity of the HSA in 2009 included 1,513 inspections, 1,198 of which specifically related to REACH, and 472 inspections of all major accident hazard sites covered by the Seveso regulations and other high risk work places storing and using large quantities of dangerous chemicals. Our EU obligations require the HSA to inspect all major accident sites and all its targets have been achieved. It has also signed a memorandum of understanding with other agencies in regard to this area and it has a dedicated REACH help desk, which answered 470 detailed queries throughout 2009. The authority presented at industry and general business conferences and hosted two seminars for people working in this area. The HSA has also participated in and given feedback to all the export committees of the European Chemicals Agency, which is a heavy workload given the documentation required, and has involved itself in UN and OECD activity regarding EU legislation.

In 2010 the REACH-CLP inspection campaign focused on the availability of chemical inventories in the workplace or the existence of some form of chemical amalgam system for chemicals stored and used in workplaces for compliance with the pre-registration of registration of chemical substances under REACH and the preparedness for the first registration deadline of 30 November 2110 as well as the availability of safety data sheets and preparedness for the classification and labelling notification deadline under the CLP regulation of 3 January 2011. That is a brief outline of the detailed work and engagement of the HSA with the industry regarding this legislation.

I thank Members for their remarks. Committee Stage will be taken during the second week of November.

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