Recall of Sanitiser Products: Discussion

I welcome from the Department Mr. Donal Coleman, deputy chief inspector, and Mr. Tom Medlycott, senior inspector.

I welcome this opportunity to update the committee on the recall issued by the Department for Virapro sanitiser products. I will briefly recount the specific issue that arose with ViraPro. In the first instance, the European Anti-Fraud Office, OLAF, notified the Revenue Commissioners regarding the import of a hand sanitiser product from Turkey to Ireland, from the same supplier of a product that had been tested in Denmark and found to contain excessive levels of methanol. Arrangements were made to test the consignment and a number of other consignments that had already been imported into Ireland from the same supplier.

All consignments that were tested were detained, pending the results of the laboratory analysis. Indicative test results were received on 6 October.

I wish to take this opportunity to correct one point in my statement to Dáil Éireann of 23 October. When using information provided to me at the time I stated that results had been received on 8 October. I should have said that preliminary results were received on 6 October. Following receipt of these results, my Department informed the HSE of initial concerns about the safety of the detained consignments of sanitiser. These concerns were based on indicative results only, without confirmatory results from a validated test method.

Confirmatory results were received on 16 October. These confirmed that the composition of the registered product was not consistent with the approved specification and, therefore, there were concerns around efficacy and public health. A compliance notice to recall this product from the market and from public use was issued to the supplier on Friday, 16 October. The product was officially removed from the official register of biocides on Tuesday, 20 October and contact was made with the procurement service of the Department of Health the same day. Then, on 22 October, my Department issued formal notification to the Department of Education and the HSE and apprised the Department of Children, Equality, Disability, Integration and Youth. My Department also took the additional step of issuing a public statement outlining the possible risks posed by ViraPro and advising the public not to use it. I was advised of the issue that evening.

Since affected ViraPro sanitiser was removed from the national biocides register in October, my Department has been proactively engaging with the supplier to ensure its instructions to recall product are complied with in full and that no further sanitiser product from the original Turkish supplier is supplied and placed on the market. My Department has also made arrangements with the Revenue Commissioners to detain any further consignments from the Turkish manufacturer in question and notify the Department. At the same time, to assist with a wider EU level examination of how this product came to breach compliance with regulations on content, all confirmatory laboratory results are being shared with the European Anti-Fraud Office, OLAF.

Responsibility for the withdrawal of products rests with the company concerned. It had become clear by 22 October that the recall of products had not yet commenced. Officials in the pesticide controls division continued to engage actively with the company to ensure a full recall could be made. However, while the company demonstrated some compliance with the recall instruction, further deadlines of 28 October and, most recently, 12 November for a full and verified recall of affected ViraPro sanitiser products have not been met to my Department's satisfaction. Officials of the pesticide controls division continue to engage with the supplier to ensure that the recall of all product concerned is fully completed. I have taken the added step of asking the investigations division of the Department to carry out a full investigation into the circumstances around the importation of this product.

I regard the protection of public health as our key priority. To ensure this, the Department continues to sample and test biocide products currently on the market to ensure their continued compliance with regulatory standards and thereby provide the necessary assurance of public safety. In this regard, 75 sanitiser products have been sampled and analysed since the end of October. I am happy to report that no safety issues have been found with any of the products checked. I believe our actions, together with the arrangements made with the Office of the Revenue Commissioners to detain consignments of concern from Turkey at the earliest stage were fully appropriate.

I am mindful of the need to ensure new sanitiser products are evaluated and registered in a timely fashion to ensure a wide range of safe products are always available to the public. Accordingly, the number of staff members in the biocides unit dealing with product registrations is being increased significantly to ensure processing times of new applications are reduced.

Committee members will be aware that there has been a large increase in applications since the onset of the Covid-19 pandemic, with approximately 500 hand sanitiser applications compared with a normal 50 per year. I am, however, satisfied that there are sufficient supplies of sanitiser available to the public to support the Government's actions on Covid-19, with more than 450 products currently approved and listed on the national register of biocides.

I made it clear in respect of the chronology of the engagement and the notification of the public that there are lessons to be learned from the point of view of the Department. Given the nature of the recall, there should have been public notification when confirmatory results were available on 16 October and the issue should have been escalated in the Department at that stage.

There are lessons to be learned there. I am also awaiting a report on the chronology around this and ensuring those lessons are learned for the future. Certainly there is confidence regarding the sanitiser and what is available. As a Department, we are taking strong efforts to ensure there is appropriate oversight of that, ensuring the available products are doing exactly what is required, and ensuring the issue which arose regarding ViraPro is expedited and completed to our satisfaction. We continue to engage in that regard.

I thank the Minister for providing that statement and some additional information. My first question relates to the clarification he provided in today's statement with respect to his previous statement on the late evening of Friday, 23 October. He said that statement should have said the preliminary results were received on 6 October as opposed to 8 October. In that same statement, he indicated that the compliance notices were issued to all four of the warehouses on 8 October. Is that date also wrong? It is just to try to get the timeline. We now know preliminary results were received on 6 October. The Minister's statement said that compliance notices were issued on 8 October. Is that date still correct? He also said that six additional samples of the product were taken for testing on 8 October. Should that also have read 6 October? Then he said the additional samples were submitted for testing to the Department's laboratory on 9 October rather than his original statement, which was that preliminary testing was on 8 October with further samples going on 9 October. There is now a delay of three days. I do not know if there is a significance in that but, perhaps, the Minister will clarify.

The Minister mentioned that his Department informed the HSE of initial concerns about the safety. I gather that was on 6 October, so it was the day the preliminary tests were filed. The Minister might confirm that and the basis on which that correspondence took place with the HSE. Was that correspondence conveyed to the HSE as the health authority, in other words, in a public health capacity, or as a body that had ordered a lot of the product? Was it expected that this was for internal management of the product that it had taken in or was it to disseminate the information? The big issues is in terms of the dissemination of the information and the time lag from when concerns were first raised through the EU anti-fraud organisation, OLAF, and the Revenue Commissioners in September to the actual point of 23 October when this became public knowledge and, as we know, resulted in schools closing for a day and all the rest.

The third question relates to one I asked when we discussed this in the ministerial questions previously regarding the financial recoupment of the associated costs. I know and gather that many separate Departments and agencies are engaged in trying to recoup some of the costs and, in some cases, have managed to have it fully recouped from their distributor or whatever the case may be. Has the Minister put a cost of this debacle to his Department in terms of all these tests and, obviously, all the internal examination that needed to take place? Is there a mechanism for the Department to recoup those costs, either from the original supplier or through another avenue?

The Minister mentioned that 75 sanitiser products have now been sampled and tested. I welcome that. It is the correct approach and I encourage that it be adopted as par for the course that these products are tested on a random basis from time to time. There are 75 out of 450. The fact they have all proven to be up to the adequate standards is also welcome.

Is this work going to commence and will the Department initiate a process whereby samples are taken from new products, either on a sporadic or comprehensive basis, in order that we can be assured that this will not happen again?

Having gone through the documentation the company provided to various Departments, including that of the Minister, it appears that it never gave the same information twice. Even in respect of its product labels - I will not go through all the references - the word "de-ionised" was misspelled, suggesting a completely different word. There are discrepancies in respect of communications, even with the HSE. At one stage the HSE indicated that it could no longer access stock from the UK, but that it had secured additional stock from Europe and confirmed it was from the same factory. The material safety data sheet provided to the HSE, however, shows that the products were different. I am told that in one case, the health business service quote from the vendor referred to the standard to which the product conforms as EU Regulation No. 1223/2009, which deals with cosmetic products rather than medical ones. All these discrepancies in the documentation the company provided to the HSE and the Department can be seen in hindsight. Will there be a review of how these products are classified, particularly if we are to rely on paper-based assessments to allow them into the market?

As some of what I had intended to raise has been covered by Deputy Carthy, I will turn to the sanctioning of the company that supplied the product. The product has been a cause of skin irritation. In case people have long-term issues down the line, have we examined how the company of supply will be held to account? In responding to Deputy Carthy, the Minister might answer my questions about the sanctioning of the supply company.

Given the current application process and the circumstances we are in, there has never been so great a need for this type of product. The Minister stated the Department has employed additional testers or laboratory facilities, but how we can expedite the licence process, in light of the urgent need, while at the same time ensuring that we will not find ourselves in similar circumstances again? Have there been any changes, based on the experience we have had, to the current application system and to the random testing of products after they have been licensed?

My final question goes back to one I asked the Minister at the previous session. As he stated earlier, we have an all-island animal welfare policy. Depending on how Brexit materialises this year or early next year, how will the all-island policy affect the licensing of products such as this one? Will products that are not licensed here be smuggled, imported or whatever from the North, or from the UK through Northern Ireland? Could such a scenario arise in this area post Brexit?

I welcome the Minister's statement on this issue. It is amazing that the Department is involved with it in so many ways, given what its brief is. I had not considered that it would be tied in to hand sanitisers and seeing what ingredients they contain, and the public definitely was not aware of that. I might return to the nub of the issue, namely, what happened in Backweston and the campus itself. Was a paper trail being followed, with documentation coming from a supplier?

Was testing actually being carried out on the campus itself? How much actual testing of the product was happening in the Backweston laboratory complex in Kildare during the early phase of the Covid-19 pandemic? Was it a case of companies issuing documentation in respect of their products, which was taken as legitimate, and the back testing not being done in the departmental complex as a result? The departmental complex located at Backweston laboratories in Kildare is significant. How much actual work was being done in those labs in the early days of Covid? Were they fully operational, with full testing happening, and what was the output from them? As I said previously, it is unusual that the Department of Agriculture, Food and the Marine was actually involved in this process. I am concerned about the throughput in the labs themselves.

The real knock-on effect applies to the public and how it regards hand sanitiser. We have one here in front of us and I was looking at the bottle as some of my colleagues were talking. There is no indication of whether it has been approved, and if so, by whom. It has to be googled to get such information. Have we thought about putting stickers on bottles of hand sanitiser acknowledging that they are approved by Department? Taking Bord Bia as an example, it has a major process of labelling its products so that the public is aware of their contents, their origin and that they are approved. There is no label on hand sanitiser bottles to say that the product is approved by the Department or it is a product that it stands over. If labelling can be used for food traceability, I do not see why the hand sanitiser companies cannot use it. I googled the bottle of hand sanitiser in front of me and its origins are in Bulgaria. Obviously I take it that the product is safe, but we need to have a system whereby a member of the public can pick up a bottle of hand sanitiser with due confidence in respect of the contents through labelling. I ask the Minister to comment on those issues.

I thank the members for their questions and comments. First, on Deputy Carthy's questions around the dates, the preliminary results were received on 6 October rather than 8 October, but the other dates are the same. I would emphasise that the test results concerned confiscated consignments which had been confiscated at the outset and remained so throughout. The Department issued a compliance notice to the warehouses to continue to detain the products on 8 October, and the day before that the Department contacted the HSE advising it to remove all ViraPro hand sanitiser products in use at the time. That was on the basis that the product had been quarantined and most of it was HSE owned, so the Department contacted the HSE on that particular consignment, and then on 7 October it informed the HSE of the advice concerning ViraPro hand sanitiser products that it was using, recommending that they should not be used. That explains the correspondence with the HSE on the issue.

On the issue of financial recoupment, that is primarily a matter for those that ViraPro was supplying and is between them. The Department is in an ongoing process with ViraPro with a view to closing out this particular issue, and it will be closed out before any further decisions are made. Deputy Carthy also raised the importance of ensuring that there is confidence in the products in the market and pointed out that out of 75 hand sanitiser products have been tested randomly, there have been no public health concerns emerging from those tests. He also asked if those tests will continue.

They are happening on a weekly basis and they will continue.

The registration of new products is a paper-based application where the company makes the application in terms of what the composition of the product is going to be, and seeks a licence to market it on the basis of the composition it is advising. It is a paper-based process and testing does not take place at that time. The important thing is that there is testing of what is on the market. In terms of assessing that very question, the assessment would be that if somebody was making an application, we would certainly expect that the initial product would be compliant and that a particular effort would be made in that regard. At the moment, it is paper-based. It is essential that testing happens and the testing of the 75 products since then has given confidence in regard to what is on the market, and that will continue.

Senator Paul Daly asked about sanctions for a company and I dealt with that issue in response to Deputy Carthy. That is an ongoing process and we will engage in that process until it is completed.

In terms of how Brexit will affect products and the potential for smuggling, in order for any product to be sold on the market in Ireland, it is legally required to have a pesticide control service, PCS, number from the Department of Agriculture, Food and the Marine. Any advice that we have issued to consumers or to companies has made it clear that they must ensure there is a PCS number on it. Any product that comes from outside the country would not have that and, certainly, the oversight mechanisms and audit mechanisms that we have in place in terms of testing product and following up, and any reports we would get, are important in regard to overseeing that. We have made it clear to members of the public, as well as to retailers, that they should ensure any product they get has a PCS number.

In response to Senator Tim Lombard, I dealt with the issue about the application process. On the numbers coming through the application process at the moment, there are 457 hand sanitisers or wipes registered by the Department that have been issued with a PCS number. Of those, 373 would have been issued in 2020, so we can see there has been a massive increase in the number of hand sanitisers over the course of the year. In addition, there are some 200 currently awaiting a PCS number and there is a 13-week wait time. I have allocated additional staff to reduce that time and I am allocating more. As members can see, of the 457, some 373 products with a PCS number have been issued over the course of the past year. With regard to that approval mark or approval certification, the indication of that is the PCS number on the product. That is what we have clarified for members of the public whenever they are purchasing product and also for companies selling them.

This raises huge issues about how the Department monitors the products that come into this country and how safe they are for use in this country. It was approved first on 21 April and, on 12 November, that product is still not off the market fully to the satisfaction of the Department, according to the Minister.

I also encountered this issue when I was on the council. Why we need to go to Turkey to source something that is made in this country is a big puzzle to me. We have all met parents and teachers since all of this broke. There is massive worry and fear out there. I had to remove this stuff from my own constituency office because I did not know about it until the story broke. It dealt a big blow to the confidence of the general public in the use of hand sanitisers, and that needs to be addressed. As far as I am concerned, the protection of public health is one of the key priorities.

What sort of assurances were received by the Department back in April when that product was being brought into the country?

Were there even any tests being done at that stage for it? In the Minister's statement in the Dáil, on 21 October, he stated that he contacted the HSE. Why was there such a delay in contacting people? Did the Minister know from the word go? On 6 October, the issues were raised and the Minister was not contacted for a couple of days. Was there any test done and what kind of assurance can the Minister give the public that these hand sanitisers, as Senator Lombard is saying, are safe? Is there any testing ongoing on any stuff that is on the market that is being brought into this country?

I thank the Minister and his officials. I have just a few questions.

I put in a parliamentary question, PQ, to the Minister asking for a copy of the test results for this sanitiser and the amount of methanol that was used in it. Unfortunately, it has not been answered. Everything but that was written about in the answer. What amount of methanol was in the product? I am not expecting the Minister to know the ins and outs of it. The Minister's officials can answer if he wants.

My understanding going back years in the Department is that it is a desktop exercise but then that the team would meet. Am I correct in saying, because of Covid or whatever, that the team was not meeting when these products were being given the pesticide control services, PCS, numbers. How often does the laboratory check these products? Is there a printout of all the different products that have been tested in the laboratory?

On the 12 week delay the Minister talked about, there are people who have put in for PCS numbers in June and July who have only been contacted for further information in the past week or ten days. That is longer than 12 weeks.

The Minister talked about the numbers and stated that more than 370 were given out this year. Is it not correct that those were temporary numbers that were given out earlier on in the year? Am I correct there was a decision made, because of the seriousness of the situation in Ireland, to give out these numbers? Early on, the PCS numbers were basically thrown out fairly rapidly? Was due process followed with all PCS numbers in that given time at the very beginning?

Finally, when does the Minister expect a decision for those who have put in for PCS numbers over the past five or six months whose applications have not yet been processed? Thankfully, there appear to be vaccines on the horizon in the next six or eight months. There is not much point in giving a PCS number to them next April or May, if we have an injection to give somebody that will result in his or her not needing hand sanitisers anymore. The Minister talks about providing more staff. How quickly will this happen? The Minister came in previously and spoke about this. In fairness, the Minister stated this service was being ramped up but the ramping up does not seem to be giving the answers in the number of applications that are still in.

First, in response to Deputy Browne on the testing, we are testing on a weekly basis a product that is on the market to verify the product will be there and also to ensure that there is confidence that it does what is stated on the label and what it is registered to do. As I say, there have been 75 of those done in the past couple of months. There has been no issue arising from a public health point of view as a result of that.

I became aware of the matter on 22 October, the day on which the public was given notice of the withdrawal. The Department dealt with it as an operational matter before that. It is not unusual for issues like this to be dealt with by the Department. Given the nature of this issue, there is no doubt that it should have been escalated to me earlier. The Department, however, was dealing with it on an operational basis, as it would deal with any issue like this. Preliminary results were available on 6 October and confirmatory results were available on 16 October, at which time the withdrawal notice was issued to the company.

The company supplying this product carries the legal responsibility to ensure that it is safe and complies with the licence to supply it. In the event of a withdrawal, the company has the legal obligation to carry it out efficiently and effectively. As I have noted, my Department is currently following through on that. That process is ongoing. I will comment further once it has been completed.

Deputy Fitzmaurice asked about test results. OLAF made contact with us on foot of tests conducted on ViraPro products in Denmark. OLAF contacted the Revenue Commissioners after tracing some of this product to Ireland. That product was confiscated and quarantined by the Department and tests were carried out. Varying levels of methanol were detected.

What levels were detected? I believe 2% is the highest allowable level.

Several tests were carried out on many samples of the product. The methanol level was generally between 4% and 10% but some levels were much higher. I will come back to the Deputy with detail on that. That product was all confiscated. Following this, the Department and the HSE have engaged with the company on product that had previously been received.

Deputy Fitzmaurice also mentioned staffing and the need to ramp up the number of-----

I mentioned the fact that the Department used to go through this process on a desktop and then convene a meeting of all the specialists involved. Am I right in saying that this was not achievable because of the virus?

The Deputy referred to temporary pesticide control service, PCS, numbers. The PCS numbers that were issued were not temporary. All Departments have been impacted by the need to work from home in recent times, but the process by which licences and PCS numbers are issued must still be followed.

Regarding increasing throughput, as I outlined earlier the significant majority of the 457 PCS numbers currently issued to hand sanitisers or wipes were authorised this year. There has been an increase in staffing numbers. Normally a staff of four process biocidal product registration applications, in addition to carrying out a range of other duties in the pesticide control division. Since the arrival of Covid-19 several other staff members within the division, approximating one and a half whole-time-equivalents, have been assisting with processing biocidal product registration applications.

A further two staff from across the wider laboratory are also assisting with processing registration applications on a part-time basis in recent months. Since 9 November a further three additional staff have been temporarily allocated to the work area and it is planned to bring in four more to deal with the backlog.

I thank the Minister for engaging so constructively with the committee today on both the Horse and Greyhound Racing Fund Regulations 2020 and on the review process of the Virapro hand sanitiser. I also thank his officials for attending.

The joint committee adjourned at 6.05 p.m. until 11 a..m. on Thursday, 26 November 2020.