Welcome to module 4 of The Life of New Substances notification training series: The New Substances Process. I'm Dan Bastien, I will be your host.
So, first what we're looking at in this section is the process at the office, so what happens to your new substances when it comes in before the risk assessment. First is, as we said in the previous module, the new substances notification reporting form and attachment should be sent to the address on the form, even if it's going to be used for foods and drugs application. So all industrial use, sole use for foods and drugs acts, or dual use, so industrial and foods and drugs act use, would have to be submitted at that address. Now what happens at that point is that we receive the information, we will enter it into our database, and then that database is going to be shared. Now, the NSN package should include your completed NSN reporting form, it could include all attachments, if there is any. And then the fee, if a fee is absolutely required.
Now the preliminary screening, now we've received your NSN, we've entered it into the database, and now it goes to the notification processing and controls unit, or the environmental assessment unit if it's a dual-use or a foods and drugs application. Now, what they will do is look at whether or not the substance, or if the package is complete. So they will look at your NSN reporting form, see that all the boxes that needed to be checked have been checked, all the data has been submitted, all the data checklist stuff from part B, part C have been submitted. And then, whether or not the information can go forward so everything is there. You have to note, at that stage we're not looking for the acceptability of surrogate or waiver requests. So is the information submitted, yes or no. Then the validation is going to be done at the risk assessment. There are 3 possible outcomes. 1: we're going to look at the data, the NSN reporting form and say that it's complete. If it's complete, then we will send you an acknowledgement letter to tell you that we've received your package. If there is anything missing, we will try to contact you by phone, if it's something that can be addressed quickly, and ask you for the information. Or we will send you a missing information letter. That means that your package is incomplete. When this package is deemed to be unacceptable, it's boxes and boxes of documents and there are no tags whatsoever, and there is no way for us in the allotted time to review the NSN to see if it's complete, we will send it back and ask you to redefine, to fix the errors. But we will, in all cases, tell you exactly what's missing, or tell you exactly what's wrong with your NSN package.
Then the package goes to the risk assessment bureau. It goes to the ecological assessment division and it goes to the new substances health and control bureau at Health Canada. They will do a complete assessment and then they will review and determine the data quality, acceptability of any of the waiver requests or the surrogate data, and then assess for the potential risk of the substance. In the next module, you will see that we go through the complete risk assessment, ecological risk assessment and human health risk assessment. So I'm not going to spend a lot of time talking about it at this point. Now you need to know, again, the pre-notification consultation is an option to you, while preparing your notification, especially in the surrogate data waiver, or experimental data. Whether or not you have questions, it's a good time to ask during the planification of your NSN. So that's why we say 'PNCs' which is a free service, is a good option to say 'we have questions and/or we're unsure about the data we're going to be submitting, can we discuss?' And then we will have a meeting with government officials and the company representatives.
Now, once the complete risk assessment has been done, there are 3 possible outcomes. The first outcome is that the substance is not suspected of being toxic or capable of becoming toxic. Or it will, it is not capable of becoming toxic in the notified uses. But then, in other uses or application we may want additional information, which is called the significant new activity notification. And we'll talk about that in the next slide. Or, the substance is suspected of being SEPAtoxic or capable of becoming SEPAtoxic, so that meaning the criteria of section 64 of the act, and we will look at that in a few slides from now. Now like we saw, when the assessment says that the substance in the notified uses is not suspected of being SEPAtoxic, but in other application we'd like to get more information as what we call the significant new activity. Now, you know that there is a starter on stack which is another presentation of this series that you can refer to, it will give you a lot more information that I give you right now about the snacks. When the substance has been deemed not to be toxic under section 64 of SEPA. But other application, we want additional information; we have 90 days after the assessment period has ended to publish a significant new activity notification. What we will do is we will publish the SNAC, we will ask you for additional information, and we will try to make a targeted, one that means we will say in what application we'd like to see additional information, so anything else is acceptable for import. You need to respect the SNAC. That means that before you begin the activity that's triggered by the significant new activity, you would have to submit the data and allow the government to do a complete risk assessment of this new activity before even beginning.
Now I said that sometimes what will happen is that we will actually have risk associated with the notified uses of the substance. So we have 3 options offered to the government at that point. It's what we call the risk management measures. So in the RMMs, there are the Ministerial conditions. When we've done a complete risk assessment and the substance is deemed to be toxic or capable of becoming toxic, but in certain conditions we mitigate the risk, then what we will do is publish Ministerial condition. It goes to the notifier, it states that you can use the substance, in what application you can use the substance, what conditions can be used. And then you're entitled to continue importing the substance by respecting the Ministerial condition. You have to know that a substance that is subject to Ministerial condition is not acceptable for DSL updates. That means that you would not have a substance listed on the DSL if it has Ministerial condition. It's one of the conditions for DSL updates. When we have done the risk assessment and the risk says that the substance is toxic or capable of becoming toxic, means the criteria of section 64, but the risk cannot be mitigated by any conditions, what we will do is Ministerial prohibition. Then when we've done the risk assessment and we believe there is a risk but we need more information to determine whether or not it can be mitigated by Ministerial condition, what we will do at that point is ask for Ministerial request for additional information. I know some of you have heard it also referred to as 'prohibition pending testing'. It means the same thing. It's just Ministerial requests for additional information state that you are not entitled to import or manufacture the substance until all of the test data required have been submitted. Just as an FYI, and just so that we give you some numbers, because when we talk about risk management measures and SNACs, people get upset. So, let me just tell you this: in any calendar year, so January to December, the New Substances program will receive about 400 notifications. Of the 400 notifications, approximately 15 will be subject to significant new activities. About 13 will be subject to Ministerial conditions that are in the entire year. For the 400, 13 will be subject to Ministerial conditions. We have not used Ministerial prohibition in the last 6 years now, and we have not imposed Ministerial requests for additional information in the last 5 years. SO just so you know, there is big talk, but we try not to use those tools unless it is absolutely required.
The other thing, and the last thing I want to say about the risk management measures, is that when the minister has determined, when the program has determined that the substance is toxic or capable of becoming toxic, to give itself enough time to write the condition or the prohibition or the request for additional information, we can and will extend the period by the same period of the assessment. So in other words, if it was a Palmer, and it was a 60-day assessment period, they say 59 or 60, we will extend by another 60 days to give us the opportunity to write the condition, the prohibition or the SNAC and submit it for your approval. So we will consult with the notifier and ensure that you're okay with the wording. And you can actually propose other wording. But at the end of the day, the 60-day or the extension is really to give us a chance to consult with you and to publish the assessment or the risk-management measure or the SNAC, because we only have that time to do it. We have to do it within the assessment period.
I thank you very much for your time, and if you have any questions, please don't hesitate to contact us.