Michael Fitzmaurice (Roscommon-Galway, Independent)
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644. To ask the Minister for Agriculture, Food and the Marine if the personnel who carry out a desktop review of products for entry onto the Biocidal Product Registers are sufficiently qualified and experienced in chemistry and regulatory techniques and procedures; if they are appropriately competent in interpreting the safety data sheets for the active ingredient, co-formulants and impurity profiles of toxicological significance of the applicant products for entry on the Biocidal Product Registers; the minimum academic and laboratory qualifications required for the personnel deployed for this work; and if he will make a statement on the matter. [42852/20]

Charlie McConalogue (Donegal, Fianna Fail)
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Notified biocidal products containing active substances which have not yet been approved under the applicable EU regulations are subject to our national system of biocidal product registrations in accordance with Article 89 of the EU Biocidal Products Regulation.

Registration of such products requires a review of information prescribed by the Pesticide Controls Division of my Department and which must be submitted by the product applicant.

This includes:

- Information on the active substance in the product

- Information on all other ingredients contained in the product

- Safety data sheets for the final product

- A proposed label that will be used when the product is placed on the market.

Evaluation of all applications for registration of biocidal products are carried out by the Pesticides Control division of my Department. Standard operating procedures are in place for specially trained staff which ensures that only products which meet the prescribed data requirements are placed on the biocidal product register.

Michael Fitzmaurice (Roscommon-Galway, Independent)
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645. To ask the Minister for Agriculture, Food and the Marine if his Department’s senior agricultural inspectors and, or professionally qualified evaluators are reviewing the approval of products currently on the Biocidal Product Registers while working from home; if not, the reason; the possible adverse consequences of same and danger to the public; and if he will make a statement on the matter. [42853/20]

Charlie McConalogue (Donegal, Fianna Fail)
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In line with the public health advice and guidelines on Covid-19 for the workplace, Department staff in the Pesticides Control Division are working from home other than when it is necessary for them to attend their workplace in person.

Appropriate practices have been put in place to ensure that all work for which the Division has responsibility for, continues to be fully carried out in a safe and efficient manner.

Michael Fitzmaurice (Roscommon-Galway, Independent)
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646. To ask the Minister for Agriculture, Food and the Marine the methods of analysis used to test and evaluate the products on the Biocidal Product Registers; if an appropriate surveillance schedule is in place to conform with best practice and established standards; if such procedures were and are in place; the reason his Department failed to identify the defective and substandard hand sanitisers prior to his Department being notified by the Revenue Commissioners; if the details of the schedule will be provided; and if he will make a statement on the matter. [42854/20]

Charlie McConalogue (Donegal, Fianna Fail)
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The test method employed by the laboratory to analyse alcohol-based hand sanitiser products is a Gas Chromatography With Flame Ionization Detection - GC/FID method for quantification of methanol, ethanol, propan-1-ol, propan-2-ol and glycerol (total alcohol screen). This method is a newly validated test that has now satisfied the conditions for full INAB accreditation.

All new biocidal products, including Virapro hand sanitiser are registered based on a documentary application. Administrative checks are applied to applications for every hand sanitiser, including technical specifications around formulation, safety data and including label approval. As this is an administrative process, no samples are submitted or analysed as part of the approval process.

However, my Department's Pesticides Formulation Laboratory had already commenced developing the above-mentioned analysis method prior to the notification by the European Anti-Fraud Office to Revenue Commissioners of an issue with Virapro.

Since this test method was developed, the Pesticide Controls Division has submitted over 100 hand sanitiser product samples to the Pesticides Formulation Laboratory for analysis. The Division also has a draft sampling plan for the period up to end of quarter one 2021. This draft sampling plan will be adapted and extended as appropriate during the year, in response to test results.

Michael Fitzmaurice (Roscommon-Galway, Independent)
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647. To ask the Minister for Agriculture, Food and the Marine if the attention of the professional personnel in his Department was drawn to a red flag warning which was widely reported in toxicology and regulatory circles and raised by the Food and Drug Administration in the United States of America earlier in summer 2020, detailing serious concerns regarding high methanol levels in some imported Mexican hand sanitiser products; if not, the reason; if his Department put in place effective measures and procedures to identify and locate these products in Ireland; if an assurance will be given that all entries into and on the Biocidal Product Registers are now being appropriately reviewed and re-examined for adverse toxicological affects; and if he will make a statement on the matter. [42855/20]

Charlie McConalogue (Donegal, Fianna Fail)
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My Department became aware, through the Health Products Regulatory Authority, of a USDA Rapid Alert regarding the presence of methanol in hand sanitiser in the United States. This information related only to products originating in Mexico with no indication of this product being made available to the EU market

As a precautionary measure, my Department's Pesticides Formulation Laboratory set about developing a new and appropriate method to analyse these types of products. This new Testing method satisfies the conditions for full Irish National Accreditation Board (INAB) accreditation.

Registration of notified products in Ireland requires a review of information prescribed by the Pesticide Controls Division and which must be submitted by the product applicant.

I regard the protection of public health as our key priority. To ensure this, my Department continues to sample and test biocide products currently on the market here to ensure their continued compliance with regulatory standards and thereby provide the necessary assurance of public safety.