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Moderator -- Welcome to Health Canada's webinar on the Canada Consumer Product Safety Act. Please note that this presentation is being recorded and the recording will be available online at a later date.
I would like to introduce Helen Ryan, Director General of Health Canada's Consumer Product Safety Directorate. Please note that questions will be answered at the end of the presentation.
Ms Helen Ryan -- Good morning and thanks for joining us. For those of you who thought you were on the French session, la session aura lieu cet après-midi. So this morning's session is being done in English.
I'm here today to give you an overview of the new Canada Consumer Product Safety Act and in particular I'm going to touch briefly on our key partners. I'm going to talk a bit about the previous Hazardous Products Act Part I and where we're at now with the new Canada Consumer Product Safety Act.
In particular I'm going to highlight industry's key new obligations, Section 14, the duties in the event of an incident, your mandatory reporting obligations, requirements to maintain and prepare documents for traceability.
I'll touch briefly on recall and other measures, some of our new authorities. I will very briefly discuss confidential business information and personal information. I'll talk to you about administrative monetary penalties and then what we're doing in terms of implementation, outreach and engagement.
So the new Canada Consumer Product Safety Act came into force on June 20th of this year, and there are some key definitions that I've highlighted on the screen there for you that are important. The reason I draw your attention to them is they are sort of the underpinning of the new Act and it's from here that we derive the authorities in terms of the kinds of things we're dealing and why we're dealing with them.
Purpose (s.3): "to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada..."
"Consumer Product" (s.2): "a product, including its components, parts or accessories, that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, ... and includes its packaging".
"Danger to Human Health or Safety" (s.2): "any unreasonable hazard - existing or potential - that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause [death or adverse health effect]...".
So in particular, what's the purpose of the Act? Well, the purpose of the Act is to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada.
In terms of what constitutes a consumer product, it's a product. It includes its components, its parts, its accessories. It also includes its packaging. And essentially, if you can obtain it as an individual for non-commercial purposes, then it's covered under the Act, with the exception of a few items.
Specifically, this Act does not include food, cosmetics, medical devices, natural health products, pest control products, fertilizers of vehicles. And the reason it doesn't is those items are regulated under separate statute. And so we look to the definition that's found in those other statutes. If they're captured there, then they're not covered by the Canada Consumer Product Safety Act. If they're not captured under those other statutes, then they do fall within the Canada Consumer Product Safety Act.
So essentially, if you're a consumer and you can acquire the good fairly readily, it constitutes a consumer product, unless it's one of these specific exemptions.
Then there's another definition that's quite important to you and that's the danger to human health or safety and it's found also in section 2. And really, what this is is any unreasonable hazard, either a real one or the potential for one, that's posed by the consumer product during or as a result of its normal or foreseeable use -- and it also includes its misuse -- and that could reasonably be expected to cause death or serious adverse health effects.
So we've been working on the new Canada Consumer Product Safety Act for some time. It was before Parliament three times before it was actually passed, and it was passed in December of this past year and came into force, as I mentioned, on June 20th of this year. It was, in part, part of the government's response to a period where we had an increasing number of recalls happening and there was a significant drive by consumers and other stakeholders for greater protection and as well to allow for more information to consumers so that they could make informed choices.
It was part of a global response. We weren't the only ones seeing this situation. We're living in a global market. Products come from a variety of places, from countries that we never imagined 40 years ago, and as such the degree of innovation and the rapidity that they come to the market gave rise to a need to modernize our legislation.
Having safe products on the market is in everybody's interest. It's in government's interest, it's in industry's interest and it's in consumers' interest, and we all have a role to play with respect to that. As a government, we have responsibility to administer, to interpret and to apply the Act in a fair and consistent fashion. This includes ensuring we provide information and guidance to people, that we conduct inspections and investigations, that we undertake corrective measures when they're warranted, and that we provide an appropriate enforcement of the Act.
As far as industry goes, they have some key responsibilities and they have some new ones under this Act that I'm going to talk to you further about this morning, including having a requirement to maintain records so that we can have a traceability of the product through the supply chain so that we know where you got it and who you sold it to in the event that corrective actions are warranted.
As well, you have requirements in terms of reporting incidents that happen that involve your product. You have responsibilities in terms of ensuring that you maintain documents, that you comply with the regulations, the existing ones, that you adhere to the general prohibition, that is, that you don't put a product on the market that can pose an unreasonable danger to people. I'm going to elaborate on those in today's discussion.
As well as the consumers, while they don't have new responsibilities under the Act, they do play a key role for us. Consumers are often the ones that bring to our attention issues with consumer products. They're the ones using them in the market and seeing where there's potential consequences, and the fact that they bring these things to our attention is quite important.
They also have a role to play in terms of ensuring that they use products in an appropriate fashion and they're following instructions that relate to them, and also that they're making informed choices, that they're choosing an appropriate product for the purpose that it's intended and for the use that they're wanting.
So we encourage consumers to report unsafe products, defects or other health of safety- related incidents, and we encourage them to report them to the person from whom they've obtained them or from the distributor or manufacturer, as appropriate. Overall, what we see in terms of that, if we're all playing those appropriate roles, we're going to find that we'll have safe products on the market and we'll have a much safer marketplace for us.
With respect to the Hazardous Products Act, this Act is 40 years old and I'm told 40 is old, although personally I find it's quite young. As I mentioned, the drive to modernize the Act was driven by a period of intense recall activity going on in the marketplace, increased demand by consumers and a concern more broadly about what was happening from a globalization perspective.
As I mentioned, products are coming in from countries that we never imagined 40 years ago. The types of products on the market vary significantly from what we thought would have been in place 40 years ago and the speed and rapidity that we see in terms of innovation and the kinds of things we face just all gave rise to the need to have a much more modern piece of legislation.
The other thing with the Hazardous Products Act is it relied very heavily on voluntary action. It was a reactive tool for us. So essentially we had to have an issue identified, then undertake a risk assessment and then put regulatory controls in place in order to manage it under the Hazardous Products Act.
It also had a limited scope in terms of who it applied to. So we saw that other jurisdictions were moving to modernize their legislation and it was time for Canada to do so as well to keep in line with its partners such as the United States, Australia and the EU.
So what do we see in the new Act in terms of new authorities and requirements? As I mentioned, the new Act came into force on June 20th of this year. It replaces Part I of the Hazardous Products Act. Again, I draw to your attention that the definition of the consumer product includes its component parts and accessories as well as its packaging, and if as a consumer you can reasonably be expected to acquire it, it's captured under the Act unless it meets one of our specific exemptions, and those things are food, cosmetics, medical devices, natural health products, pest control products, fertilizers and vehicles.
So under the Act there is now a new general prohibition. The general prohibition is found under sections 7 and 8 of the Act, and essentially they're provisions against the supply of consumer product that pose an unreasonable danger to human health or safety.
So this is an important new consideration under the Act. The general prohibition is going to allow for much more prompt and effective action where there's a danger to human health or safety and where those dangers have been clearly identified.
Under the Act, there are provisions for orders and other tools that relate to products that pose an unreasonable danger and so the Act gives us measures and means for us to deal with products that do make their way to the market that can pose an unreasonable danger.
The Consumer Product Safety Act came into place as part of a broader comprehensive response to increased problems that I mentioned to you already and also the recognition that there was a need for broader authorities to help better support a more active prevention, target and strategic oversight and rapid response.
The legislation specifically includes the power to compel product recalls or other corrective measures where circumstances warrant. So where industry is not taking action or where the action that's occurring is not occurring at a swift enough pace, it allows for corrective measures. It includes increased fines and penalties, including administrative monetary penalties (AMPs). That's essentially like a ticketing regime, and in order to put the AMPs in place, we need to put a regulation in place and that will be happening later on this fall or winter.
It also has provisions for record keeping to allow the traceability of the products in the event of a recall or other corrective measure. It has provisions for mandatory reporting by industry of incidents related to their products, including near misses. We have the authority to require test and studies to help verify compliance and non-compliance. And there are provisions that relate specifically to the sharing and disclosure of information.
Table 1: Summary of Regulatory Activities.
On the next slide you will find -- and this is not meant for you to pay particular attention to reading each and every line. Essentially the key message on this slide is that if you were subject to a regulation that existed prior to June 20th of this year under Part I of the Hazardous Products Act, all of those regulations have been transferred and they are in effect now.
So the purpose of this slide is to just highlight that while the acts are not identical in language -- so the language used under the Hazardous Products Act is slightly different than the language that's now used under the Canada Consumer Product Safety Act -- so for some of these regulations, we had to make some administrative changes in order to have consistency of language and that's why you have checkmarks in some of the other boxes. But essentially the bottom line here, if you were subject to a regulation prior to June 20th, you continue to be subject to the regulation and to the same regulatory requirements today.
In the lead-up to the coming into force of the new Act, there was quite a focused attention on the mandatory reporting provisions and I'm going to talk in more detail about those mandatory reporting provisions, but it's only one part of the overall strategy for safer consumer products in Canada.
I want to remind you that it is a post-market regime for consumer products in Canada and it does support the free flow of goods. I think there are some other things that are important to note.
We have enjoyed and continue to enjoy a very strong relationship with our industry partners and they have been instrumental both in the development of the Act itself and in the implementation of the Act that we see today, including the development of guidance documents and the testing of our online web-based tool for mandatory reporting, as examples. We expect that that will continue to be the normal state of play for us, that we will continue to enjoy excellent cooperation with industry, and the majority of the actions that will occur will continue to occur on a voluntary basis.
Many of our industry partners already have robust health and safety processes in place to help take quick action on those products that may pose a risk and it's these types of policies and procedures that we think are the same or similar to what you need to have in place in order to support compliance with the Canada Consumer Product Safety Act.
People are used to dealing with returns at return counters. People have ways of dealing with warranties in situations like that. People have been dealing with product defects, have been initiating corrective measures and voluntary recalls, and where you have a robust system that underpins that and mechanisms in place that allow you to deal with that in an effective fashion, well, those are essentially the same kind of provisions that you need in place today to help comply with the new Canada Consumer Product Safety Act.
The Act modernizes and helps us be better able to protect the health and safety of consumer products and of consumers. It ensures consistent safety responsibilities for industry while giving the Government of Canada modernized tools to take action if required. It reflects years of extensive consultation with a range of stakeholders, including industry, consumer advocacy groups, standards development organizations and the general public. As I mentioned, it went before Parliament on three occasions.
There was significant engagement in dialogue around that and changes were made to the Act to reflect those comments and that dialogue. There was in excess of 50 stakeholder groups that were consulted in the development of the Act and we will continue to focus our attention on the continued cooperation that we enjoyed both in the development of the Act, as I mentioned, and also in the development of the tools that we spoke about. And so this collaboration is quite important in terms of promoting and ensuring safe consumer products and ensuring compliance with the legislation.
As I mentioned already, the Act does cover the majority of consumer products unless they're specifically exempt. Essentially, if you're a consumer and you can acquire it fairly readily and it's not one of those exempt items, it is covered by the Act. And as I mentioned already, it includes its component parts and accessories as well as its packaging.
So let me elaborate more on the key industry responsibilities. The Act holds important new responsibilities for industry. There are mandatory reporting requirements of health-and-safety-related incidents that involve consumer products. I'm going to elaborate on that further. There are mandatory recordkeeping provisions for the traceability of products through the supply chain. We have new authorities that allow us to be able to require test, studies or other information in order to ascertain compliance or non-compliance.
As I mentioned already, there's a new general prohibition, and specifically, no manufacturer or importer can import, manufacture, advertise or sell a consumer product that they know is a danger to human health or safety, is the subject of a recall or an order that's been made under section 31 of our Act. And if you're under the Act, there's an ability to ask for a review of order. If it's also the subject of a review, you can't. And so these are quite important. In addition, there's a number of responsibilities that continue to be in place that existed prior under the old Hazardous Products Act.
So there is a list of consumer products that are prohibited. They continue to be prohibited, for instance, baby walkers. You need to comply with the regulations, as you would have in the past, and ensure that you're maintaining the documents and adhering to the requirements, and you're expected to deal with the requirements in terms of the general prohibition and the maintenance and access for inspectors, as you would have in the past. So those essentially highlight the key responsibilities of industry under the new Canada Consumer Product Safety Act.
Now, to just drill down a little bit further in terms of elaborating on those that are new to you, I'm going to talk a bit about mandatory reporting.
Mandatory Reporting is the requirement for Industry to report any incident related to a consumer product they supply as outlined in Section 14 of the CCPSA: Duties in the Event of an Incident.
Mandatory reporting, the duties in the event of an incident are found in section 14 of the Act, and essentially it's the requirement for industry to report any incident that relates to a consumer product that you supply that's outlined under section 14. I should note we have developed guidance on mandatory reporting.
So online there is available to you a mandatory reporting guide and it helps walk through all of these requirements that I'm going to touch upon today. They're elaborated on in the guide. In addition, I should mention that we do have a web-based reporting tool to help facilitate the reporting of these incidents.
So essentially, the intent of section 14 is to help provide better intelligence on how consumers use products, what the potential risks are with respect to human health and safety from those products. It's to help enable an early and proactive response to emerging hazards and trends and it's to help respond where appropriate to health and safety issues that are caused by these products.
So people say, well, for every incident that gets reported, Health Canada is going to take an equal and opposite reaction, and I'm here today to tell you that that is absolutely not the case. You will find as we elaborate further on the mandatory reporting requirements that there are two provisions. The first one is that you tell us about it. The second one, if you're an importer or if you're the manufacturer in Canada, that you advise us of what corrective actions you're taking to remedy the situation, and if you're not taking corrective actions because you don't feel they're warranted, why you're not.
So really, what this is doing is it's giving us intelligence about how consumer products are used and the types of hazards that they pose. And we know that people use things in odd ways and it doesn't mean just because there's been an incident that there's an action that's needed. However, we may find when we see over time that there's a trend that develops, and that trend may be that consumers just aren't using products in an appropriate fashion and that we as the government need to engage in a public outreach campaign to help them better understand how they should be using things.
For instance, we may need to launch a safe sleep practice to help parents understand the issues with respect to child safety in terms of sleep. We may find that there are other factions that are warranted in terms of our public education and outreach. We may also find that we're seeing that there's a trend, and while a specific industry may not note that, we see across the spectrum of the products that there's an issue with a particular either component or an element that's causing an issue with consumer products.
And so it's through that strategic oversight and the analysis of the types of incidents that we're getting that we can identify these things and move to take early action, so either in dialogue with industry about what we're seeing, through reporting outwards to others or through specific follow-up action with the industry themselves.
So as I mentioned, the intent there really is to help provide that intelligence about how consumer products are used in the market, and where there are issues to help identify early action. Industry is actually being asked to identify what those actions should be. It allows us an opportunity to work with them to ensure that we find that they're appropriate and that they're managing the risk in an appropriate fashion, but also if there's need for broader action, it gives us that early intelligence to help deal with the issues swiftly and in an effective fashion.
So how do I figure out whether or not I have an incident and I need to report? So what we think -- you can frame these by three primary questions, and these are just to help guide you in figuring out whether or not you have a mandatory reporting. So you have to think about what is a reportable incident, so what criteria do I look at there; then when do I need to report the incident; and how to I report the incident. So I'm going to walk through each of these for you.
Upon learning of an "event" that may involve a company's product, it is expected that the company undertakes an evaluation to determine if it meets the requirement to be reported to Health Canada and if the product involved is a consumer product as defined in the legislation.
This determination is undertaken prior to timelines commencing for the mandatory incident reports.
The following questions can assist in the determination of a reportable incident:
So what is a reportable incident? To help determine whether or not the event in question is reportable, the supplier can use the following sequence of questions. And they're just meant to help guide you. This is not an exhaustive list of the types of questions that you might want to ask yourself, but these are some of the key questions you should be thinking about in helping determine whether or not you have a reportable incident.
So first, is it a consumer product that I sell, manufacture or import, and as I mentioned, including its component parts or accessories? Now, you might think that's a statement of the obvious, but we do know that there are copycat articles out on the market and someone may return a product to you and you find that it's actually not your product.
The other thing, we also know that there are odd things that happen at return counters. So I may have thought I purchased this product at Sears, for example, when in fact I purchased it at Walmart. So when it comes to the return counter, you have to make a determination. You have to figure out -- they may have taken it back, but then when you look at it, you look into your inventory, you find that this isn't a product that you carry.
So the first thing you have to determine is whether or not it's a consumer product that I sell, manufacture or import, and it could be just part of its components, it doesn't have to be the full product itself.
Then you have to ask yourself, is my product connected with the suspected incident? Now, we're not going as far as to say that there's a causal effect here, but is it connected? So the mere fact that your product was in a house that caught fire doesn't mean that it was connected. However, it may have been an electrical appliance that was connected to something else and that in fact it contributed to the overall incident. So you need to look at that issue specifically and determine whether or not your product was connected.
Then you need you ask yourself, does it meet the criteria that are elaborated in the Act under sections 14(1)(a) through (d) about what constitutes an incident?
And then the last question -- or not the last question but one of the key questions you should be asking yourself is, does it indicate an unreasonable hazard that's posed by the normal or foreseeable use or misuse of the product? And when we think about that, we need to think about what constitutes a danger to human health or safety, and I talked to you a bit about that at the beginning of our presentation.
So it's really an unreasonable hazard -- it's the existing or the potential for one -- that a consumer product poses during its normal or foreseeable use and that may reasonably be expected to cause an individual sorry, that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on the individual's health, including an injury, whether or not the death or adverse effect occurred immediately or after the exposure. And it also includes near misses.
So how do I figure out if it's related? So is my consumer product connected or involved in the incident or the event in question? You need to really look at the product itself, including its component parts. So it may be that it's your product in its entirety, but it may be that it's a component of it.
So, for instance, it could be that there's an issue with a switch on your stove that's the issue and that that switch is problematic through a series of different stoves. So you would look to see is it mine, is it something that I have, including the individual component parts or accessories, and does it relate to the issue at hand? So you need to look at that, and as I mentioned, it doesn't actually have to be the full product itself, it can be just a part of it.
Then the other thing you have to say is, is it somehow connected to the event at hand, right? So it's not just the mere fact that I cut myself with a knife. If you were to see me in my kitchen, you would find that I cut myself regularly with knives because I'm extremely uncoordinated. That doesn't mean that there's a problem with that product. However, it doesn't mean that there's not. There actually could be a design issue or a defect or some other consideration with that knife that's causing these issues, and so that's what you have to evaluate.
So it's not the mere fact that someone comes to you and says I cut myself with this knife that you have an issue, but you have to look at the product itself and determine whether or not it was connected to it and it had an indication around it. And that's when we talk about the normal or foreseeable use or misuse. So you need to look at that itself. Same thing -- we know chainsaws are inherently dangerous, right? They're designed to cut things.
So you have to look at those specific products themselves to help figure out whether or not they're connected to it and whether or not they are posing an unreasonable hazard. I'm getting a bit ahead of myself in terms of the slide that you're seeing on the screen, but it's all related in terms of determining is it related to the incident.
So when you look at -- you know, you say to yourself, okay, I've figured out this is a product that I actually import, manufacture or sell, and yes, the product itself or a part of it seems to be connected to the incident that we're talking about, then what I need to look at is there are some key criteria that are identified in sections 14(1)(a) through (d) of the Act.
And so they talk about, you know, was there an occurrence in Canada or elsewhere that resulted or could have resulted in an individual's death or in serious adverse effect on their health, including a serious injury? So has there actually been something that's happened of that nature or that could reasonably have been expected to happen? So there we're talking about a near miss or the potential for this injury. Is there a defect or a characteristic in the product itself that could have caused an individual's death or serious injury or the potential for one? Was there incorrect or insufficient information on the label or on the packaging or the lack of that instruction or information that also could have reasonably been expected to cause that death of injury or that that injury or death actually did happen?
And then the other criteria is, has there been a recall or another measure that was initiated for health and safety purposes by another jurisdiction, including foreign entities? So has somebody else taken action with respect to this product in another jurisdiction and have they done so specifically for health or safety reasons because that is one of the criteria in terms of what constitutes an incident, an area where we do want to see reporting. When we talk about criteria (1)(a) through (c), we need to think about as well the normal or foreseeable use or misuse of the product.
For an event to be an incident, particularly for paragraphs 14 (a) to (c), it should be determined that the event indicates an unreasonable hazard posed by the normal or foreseeable use or misuse of the product.
Experience and judgment need to guide whether the consumer product was being used as it was originally intended to be used but must also extend to foreseeable but unintended use of the product.
Foreseeable use would include not only the use of a consumer product for its primary, ordinary or intended purpose, but also the misuse of a product that is reasonably foreseeable. What constitutes normal or foreseeable use of a consumer product will depend on the particular product involved, and with the circumstances surrounding the event.
So I talked about the fact that, you know, I cut myself with knives, right. Does that mean that that's a type of incident that needs to be reported? Well, you need to now look at this criteria of foreseeable use or misuse and whether or not the product actually poses an unreasonable hazard. So that's there this dimension of judgment and what the product was designed for and how it's intended to be used are -- you have to look at those considerations in order to help make a determination about this.
So it's really going to be your experience and your judgment that's going to guide this and we know that this may change with time, particularly as it relates to misuse of products, because it's really -- You know, you may have someone come in and they're juggling chainsaws, right, and they're injuring themselves with them. You say, well, that's not at all what this thing is designed for. And so that would be something that would be outside of these considerations.
However, if we find now that there's a whole vogue and there's online series that are actually designed for people to use to juggle, well, the fact that people are then getting injured in this fashion, you would need to reconsider. So if this becomes something that's more normal and should be foreseeable in terms of its misuse, then it would be informed by those incidents and by that information.
So the first time -- and the juggling chainsaws is probably not a very good example of it. A better example would probably be a child using a product in a certain fashion. I know we have psychologists and others that help in the design of these products and they try to anticipate how children might use them.
We also do -- manufacturers and others do testing with them to see how they actually use them. But children are extremely innovative and they can find and do the most bizarre things with things. So if we find -- the first time you see that, you might say well, that's really, you know, a one-off. We can't recreate it in the lab. We have no idea, you know, how that came to be. And then you find over the course of the next little while that you get two or three or more of these same types of incidents and the product is being used in that same fashion. Well, now you might adjust your concept of what is considered a foreseeable misuse and that's because you're now informed by your experience and your judgment and the fact that you didn't report that the first time, it doesn't matter.
We know -- in Health Canada we are also informed by the information that we see, the trends that we see in terms of our information about whether or not this is something that should be foreseeable in terms of its use or its misuse, and so that experience and judgment is key and there's no specific cookie-cutter recipe for how you can do that. So the foreseeable use would not -- would include not only the use of the product itself for its primary purpose or its ordinary or intended purpose, but also, as I mentioned, this misuse that we talked about.
And you really have to drill down on how that product was used, the particular circumstances of it, the actual specifics around the product itself in terms of how it was designed, what it was meant for, and the inherent dangers around it. All of those things are brought to bear in the determination of whether or not it poses an unreasonable hazard as a result of its foreseeable use or misuse. And as I said, we know that this may change with time as you gain experience and judgment. The other thing we know is this may also change depending on where you are in the supply chain.
So, for instance, if I'm a retailer, my understanding and my experience and judgment with respect to a product may be different than if I'm the manufacturer themselves, because the manufacturer has a depth of knowledge about the product and the product design that the retailer does not. So what a retailer's consideration and judgment would be on this issue and what they may conclude may be different, and so that's important for you to note.
The CCPSA requires a person to determine whether an event involving a consumer product that they manufacture, import or sell in Canada for commercial purposes needs to be reported to Health Canada. The following questions can assist in the determination of whether an event is a reportable incident:
Once a person has information from which one may reasonably conclude that there is an incident related to a consumer product that they manufacture, import or sell in Canada for commercial purposes, they are considered "aware" of the incident. The CCPSA then requires that the person provide information to Health Canada and, if applicable, to the person from whom they received the consumer product.
Under Section 14(2) of the CCPSA, once the manufacturer, importer or seller becomes aware of an incident, they are required to provide all the information in their control regarding any incident related to the product within 2 days after the day on which they became aware of the incident to Health Canada and the person from whom they received the consumer product.
In addition to submitting the subsection 14(2) information, the manufacturer or importer is required to provide a written report to Health Canada within 10 days after the day on which they become aware of the incident as noted in Section 14(3) of the CCPSA. The report must include:
So if we look to the next one, we've developed a placemat to help guide you in terms of going through this. Like when you are faced with an event and you're trying to figure out whether it's reportable, again, you need to go through a series of questions. These are not comprehensive, as I mentioned. There may be other considerations that get brought to bear. But the things you need to be looking at, again, are does it relate to my product, so is it a product that I manufacture, import or sell, including its component parts or its accessories, and if so, was the product connected to the event? Does the event itself meet the criteria, one of the criteria, of what constitutes an incident under section 14(1)(a) through (d) of the Act?
So remember, I spoke to you about: - whether or not there's been a death or a serious adverse health effect, and this includes near misses; - whether or not there's a defect or a characteristic with the product which could have led to a serious adverse health effect or death or which did; - whether or not there was incorrect or insufficient information or the lack thereof that could have led to those issues as well; - and then the last one is whether or not there's a recall or a measure that's been undertaken by another jurisdiction, including foreign entities, and that they did so for the purposes of health or safety.
So if you say, well yes, now I see it's my product, it was connected to the event in question, it does meet one of the criteria that's defined in the Act, then I have to ask myself, well, does it pose an unreasonable hazard as a result of its normal or foreseeable use -- and again, we talk about it includes misuse -- of that product? And if so, now you say yes, all of those things are true, well, you've now just become aware that you have an incident.
Now, the term "aware" is important because it's actually a term that's used in the Act. So it's once you've gone through the determination, you've asked yourself those series of questions and others and come to the conclusion that you do have an incident, you're now aware that you have an incident, and under the Act you have two days to report to Health Canada.
So that's what you see, that yellow bar on the bottom. You have two days from the time that you become aware. If you are a manufacturer or an importer, there's a second provision under the Act, under 14(3) of the Act, and that is that you must submit a written report to us outlining the corrective actions that you're taking to help remedy the issue that was identified or if you're not taking corrective actions, why you're not taking corrective actions. And as I mentioned before, this awareness and determination can change depending on where you are in the supply chain.
The consumer voluntarily reports an event to the seller (retailer) or Health Canada.
The seller (retailer) is notified of an event by the consumer. If they determine that it is a reportable incident, the retailer makes a mandatory report under subsection 14(2) in two days to Health Canada and to the person from whom they received the product (the distributor).
The seller (distributor) is notified of an incident by the seller (retailer). If they determine that it is a reportable incident, the retailer makes a mandatory report under subsection 14(2) in two days to Health Canada and to the person from whom they received the product (importer/manufacturer).
The importer/manufacturer is notified of an incident by the seller (distributor). If they determine that it is a reportable incident, the importer/manufacturer makes a mandatory report under subsection 14(2) in two days to Health Canada. They also must provide a written report to the Minister in ten days under subsection 14(3).
So who do I report to and when do I report? If you're a consumer, we expect that they're going to be drawing their attention to Health Canada. They may be letting us know about incidents. I must say that we actively encourage consumers to report the event to the person from whom they've acquired the good or the manufacturer or importer so that they're talking directly with you with respect to the incidents. We also ask them explicitly for permission to share any information that they provide to us of a personal nature so that we can provide you directly, if they don't, a copy of the incident complaint form. If they're not willing to disclose personal information, we'll look at the information at hand and we'll convey on the generalities of it to you to help you in determining whether or not you have a reportable incident.
So we're expecting, though, the vast majority of them will be reported directly to retailers, distributors and manufacturers. People are returning products when they're unsatisfied with them and making you aware of their concerns. And so if they bring it to a retailer -- again, we went through this, you each have an ability as you go up the supply chain to make a determination about whether or not you have an incident.
And so if you're a retailer and you've come to the conclusion that you do have an incident as far as you're concerned, once you have that awareness, you have to report to Health Canada within two days.
You also -- there's a secondary requirement to report. You also have to advise the person from whom you acquired the good that you have filed a report with Health Canada, and our online tool allows you to click it and convey it as an email to the distributor or the importer or both. So you can take a copy of the report that you're submitting to Health Canada and forward it on to the distributor or manufacturer or both of them so that they see the information that you provided to Health Canada. It also facilitates the reporting for the next level up in the event that they're also concluding that they have an incident.
So if you're a retailer and you conclude you must report within two days, you also must advise the person from whom you acquired the good. The same holds true for a distributor. And if you're the manufacturer or importer and you come to the conclusion that you have a reportable incident, you have two obligations. You have to report to Health Canada within two days that you become aware of the incident and you have to report within 10 days. You have to do a follow-up report which identifies the corrective measures that you're undertaking.
And again, I need to stress that for each person in this supply chain, you have a separate and distinct opportunity to come to a determination that you have a reportable incident. So it's not the fact that a seller or retailer concluded that they had a reportable incident that you automatically will come to that conclusion. You have the opportunity to walk through those steps that I talked about: so is it my product; is it connected to the event in question; does it meet one of the criteria of what constitutes an incident under the Act; and does it pose an unreasonable hazard as a result of its foreseeable use or misuse.
So each level of trade has an opportunity to undertake that assessment and you may come to a different conclusion. What we do ask you to do if you come to a different conclusion and you don't think you need to report, we would suggest that you indicate back to us by clicking the notification box on our online reporting form to let us know that you've come to a different determination. And the reason that I say that is if it's a high-risk item, at Health Canada we're going to be looking for that report.
Example of a Consumer Product Incident Report Form for Industry.
So we're going to see this has come in from a retailer. We're going to be looking at it. We'll say, well we figure, after it's gone through our triage process, that there's a high risk. With high-risk incidents -- high-risk products, we are undertaking an assessment ourselves to see whether or not there's some action that's warranted. If we haven't heard back from you, we're going to be knocking on your door. So rather than have to go through that, if you just click off the notification box on the online form, you can advise us of what you found and why you don't think there's action warranted.
So how do you report? There's been a web-based tool, as I mentioned, that's been developed. And I need to take this opportunity to thank industry because we had some quite active and effective engagement from industry both in the development of the reporting guidance material for mandatory reporting but also in the trial testing of our web-based application. So I want to thank those that participated.
So we have a web-based tool to help facilitate this exchange with us and what it does allow you to do -- so this web-based tool, you can go through it, you can file both your two-day report and your 10-day report at the same time. And I need to stress, you don't have to wait 10 days to file the 10-day report. If you know immediately what you're doing, you can let us know immediately and you can fulfill both obligations at the same time.
But what it does do is that our system provides a case number for the file. When you complete the form, you can take a copy of it; you can attach photos; you can attach spreadsheets; you can attach documents to it if there's subsequent information that you think Health Canada needs to know about; you can keep a copy of it for your records; you can print it off; you can email it to others up the supply chain if you're a retailer, if you want to send it on to the distributor or manufacturer. The form enables all of that. You submit it to Health Canada online.
If you get it and you're the distributor or the manufacturer and you receive an online report, a web-based report from your retailer, for instance, you can just click open that report and it allows you to just update the information. So if you find that all the conclusions that they came to about it are similar for you, it will ask you whether you want to just update the information or whether you want to put new information in.
So that was a way to help facilitate the flow of information and facilitate the communication up the supply chain. So we actively encourage people to use the web-based tool. The online form gets submitted to Health Canada and within a matter of hours we get a notification into us indicating that there's a new incident that's been submitted and it gets uploaded into our system.
So then what we do is we undertake a triage assessment of that to determine (1) whether or not the product was something that's captured under the Act. If it was something that was actually meant to be covered by one of our sister programs within Health Canada, we will refer it on to them or say, for instance, it was actually something that was meant to go to Transport Canada, we'll refer it to them. Otherwise, we go through a triage and figure out if it's high risk.
As I mentioned, for those high-risk ones, we are looking at them in more detail and we're undertaking an assessment of them. We're looking to see what's come in from the higher levels of trade. We're also looking to see what corrective actions are being proposed. If we're not hearing back from you with respect to that and we think we should, a regional inspector may be in contact with you.
As well, we may be looking for more information in terms of studies, tests or other reports and are in communication with you with respect to that. If not, what happens is, as I mentioned, this whole objective of mandatory reporting is to help provide that strategic oversight to allow us to do an analysis of what we're seeing in the market, to help look at it in the context of information that we get from coroners, from fire departments, from hospitals, in the media, from other jurisdictions.
And so we monitor and review the incident reports that don't get referred on either to our compliance and enforcement group or our risk assessment groups on a weekly, monthly and quarterly basis depending on the nature of the issue and are looking to see if there are trends or other issues happening in the market that suggest that we need to take some type of action, and as I mentioned, that action could be something like a public outreach campaign or an updating of our guidance material that we provide to the public about what we need to see.
The other requirement that is new for you is the document retention requirement and you can see why it's important for you to know about the products, who you're getting them from and who you're selling them to. Already from a mandatory reporting purpose perspective, you need to know who you got it from because you have to advise them.
You have an obligation to advise the person from whom you got the product about an incident that you're reporting. So there is a requirement under the Act -- it's found under section 13 -- about traceability of the product. And, as I mentioned, it's the ability to allow us to track and follow the consumer product through all stages of the supply chain, and essentially it's a requirement for you to maintain documents about who you got the product from and who you sold the product to. And they're very similar to the requirements that you have for bookkeeping or tax purposes, for instance, your GST. This type of information is the type of information that you maintain there.
And so if you're a retailer, the requirements are slightly different. So the retailer has to prepare and maintain documents that indicate the name and address of the person from whom they obtained the product, but we don't ask you to maintain this type of information for your customer base. So we don't expect that you would keep a detailed customer list. What we do expect you to keep and what you are required to keep is the location and the period during which you sold the product. So that's the retailer's new obligation.
If you're any other person in the supply chain -- so if you manufacture, if you import, if you advertise, if you sell, if you test, if you distribute -- you have to prepare and maintain documents about the name and address of the person from whom you obtained the product and the name and address of the person to whom you sold the product. If you do both activities, you need to maintain both. If you only do one of them, you keep the portion that is applicable to you. And again, I stress that the reason we want this is so that we can trace this information, the product up through the supply chain. It's also to facilitate that mandatory reporting that we talked about.
I should just draw to your attention that these new requirements do not replace requirements that you have prescribed for you in regulations. So on the slide when you see that wording "prescribed documents," that's where in a regulation there's a requirement for you to maintain documents. So, for instance, some of our regulations require that you keep evidence of the consumer product, that it met the requirements of the Act. So, for instance, under the CCCR Regulation there's a requirement for you to maintain documentation, and so that requirement continues to be in effect.
How long do you have to keep these documents for? So as I said, we mirrored the provision that you find for tax purposes, for bookkeeping purposes, and we've mirrored the time period for which you have to keep them. So essentially you have to keep the documents for six years after the end of the year to which they relate.
So if I, on June 25th, acquired a product from someone and I sold it to a retailer, I would need to keep the documentation about the name and address of the person from whom I obtained the product and the name and address of the person to whom I sold the product for six years after that period, and it's the end of that calendar year. So that would take me to December 31st, 2017. So if I made that acquisition or that sale on June 25th of 2011, I have to keep that document for six years after the end of that year, which brings us to December 31st of 2017. As I said, it's the same provisions that apply for tax purposes.
There's also provisions in the Act that say that you have to keep your documents in Canada. And really, what this is about is we need to ensure that we have quick and rapid access to this information. You recall, the purpose of this is to allow us to trace the products up through the supply chain in the event that there's corrective action that's needed or recall, but it's also to allow you to know who you have to report to. So you need that information, it needs to be readily available, and so you have to maintain those records.
People ask us, but if I maintained it on a server that's located outside of Canada? But when an inspector comes to your workplace and I can get that information directly off your desktop or in that office there physically, then we deem that to be considered maintained in Canada. So what's important about this provision is that we have quick and easy access to the information so that we can deal with the issue in a timely fashion.
There's also a provision that the Minister can grant an exemption. If for some reason you can't keep your documents in Canada and if you're physically keeping your documents elsewhere, then you can make an application to have an exemption for this provision. But what we're going to be looking for in any application is the same issue, how quickly and easily can we gain access to this information.
The other thing that's important to note. So you may not keep your physical documents in your office. You may keep them in a building that's adjacent to it or at another location in that city. What will be important to us, again, is that we can gain quick and easy access to them so if an inspector comes to your workplace or calls you and is asking for this information, you need to be able to give it to them within about a 24-hour period in order for us to be able to follow up. And I would say actually for the purposes of mandatory reporting, you need to have that information readily on hand so that you can report to your distributor or to your manufacturer up your supply chain when you're reporting in to us.
The other thing I should note is if you were asked to undertake a test or a study, we will make that request to you in writing and we will specify if it needs to be maintained. So there are provisions for other kinds of documents that we can ask for and so we would specify what those are.
I should also note. Remember, I said there's prescribed documents. Well, it could be -- there are prescribed document requirements under regulations and there are prescribed timelines. So the six-year timeline is for the traceability provision only. The other provisions are as specified in the regulations themselves. So I just wanted to emphasize that point for you.
There also are provisions for exemptions under the Act and section 4 of the guidance document sets out exemptions for recordkeeping requirements. I talked to you about the purpose of generating these documents and why we're asking you to maintain them. It's for the traceability of the supply up through the supply chain. It's in order to allow us to take swift action when necessary either for product recalls or in the event of a corrective action, but also to help with the mandatory reporting provision.
So we have been looking at and we did generate a public consultation document about the interest of exempting donated products from this requirement, and the reason that we proposed this and that we're actually behaving today as if this exemption was in place is because it doesn't help in the determination of the traceability of a product to know that Helen Ryan as an individual donated, you know, two boxes of clothing and five toys to the Salvation Army. That doesn't actually help you in figuring out what to do in the event that there's a recall or a corrective action that happens because I don't have any control around that and you won't know where I got it from or there may be nothing about that information that's available to you. And it would be extremely onerous and administratively heavy to do so and there would be no benefit from keeping that information.
However, if I am a retailer or a distributor or an importer or a manufacturer and I donate an end of lot, I donate a series of beds, I donate some stoves, I donate a series of products to the Salvation Army or to others, well, there would be interest because if there's a product recall that involves that product, it would become important to know that it affects people who had these contributions.
And so there is -- as I mentioned, we did go out for public consultation on putting in place an exemption for donated products. And for the purpose of this policy, "donation" is the giving of a product for no consideration. And "consideration" is anything that could be of value for a person. So, for example, a tax receipt issued to a person who has made a gift would be deemed a consideration. So the exemption for the documentation would apply to a person who meets the following conditions: - Any recipient of a consumer product where the consumer product is donated -- so it's given for no consideration -- and the donation is from a person other than a manufacturer, importer, distributor or retailer.
And so, as I mentioned, we did go out to consult on this provision and we are now moving forward with putting a regulatory proposal in place to put this exemption in place, and as we stand, the government is actually behaving as if this exemption was in place. So we're not expecting that this type of documentation is being maintained at present.
If you're interested in this specific exemption, I encourage you to visit our website and actually sign up for our Web service because we do post information related to any regulatory consultation along with any other information that's new about the Canada Consumer Product Safety Act on our website, and if you sign up, what will happen is you will get an email notification saying that we've put something up there. You will get the subject of what it is and then you can go and look into it further.
So we expect that this regulatory proposal will be posted sometime late this fall, early winter, and that it will move through our normal Canada Gazette process, so Canada Gazette Part I and Part II. So, as I said, I encourage you to visit our website.
I also encourage you to visit our website because all of the guidance documents that I spoke about, that placemat tool that you saw, as well as a number of other products, including a bunch of frequently asked questions, are on the website and are updated regularly. So I encourage you to go and look at those products.
So with respect to the proposed exemption regulation, also in our consultation that we held last year we looked at whether or not there should be other provisions with respect to exemptions for other considerations. So we have a consideration to allow, under very specific conditions, the exemption of the manufacture, importation, advertisement or sale of non-compliant consumer products, but for the purposes of export, bringing the products into compliance or for testing, research or exhibition.
So there was a draft proposal about what Health Canada should do with respect to these types of exemptions. Again, we don't know where the government will fall on them -- not literally fall on them because that would be unsafe, but what will happen with respect to the policy considerations around these items -- but we expect that there will be as well a regulatory proposal on these types of exemptions and that that would be something that would be coming later this winter.
So if you're interested in these types of exemption provisions, so allowing you to bring in, to manufacture, to import, to advertise or sell a non-compliant product for the purpose of export or for the purpose of bringing the product into compliance or for the purpose of testing, research or exhibition, I highly encourage you to monitor the website as well. There will be a determination made over the course of the winter, at least in terms of a draft regulatory proposal that will articulate what the government's thinking is with respect to that. So again, I encourage you to pay attention there.
I mentioned briefly to you that one of our new authorities is that we can ask for test, studies and other information. This is a new authority for us and it allows us to both verify compliance or to prevent non-compliance with the Act and the regulations. When we're looking for this information, we will do so in writing and we will let you know how long you should be keeping the information for. So that's one of the new provisions and you may be asked for this type of information.
I told you that I would speak briefly about confidential business information, and I'm only going to do so very briefly, because the key message here is the Government of Canada protects confidential business information and personal information. There are specific legislative requirements for us to do so, to treat this information in an appropriate fashion. They're laid out in the Privacy Act as well as in the Access to Information Act. So nothing that I'm going to tell you today would change any of those requirements. However, what we do find in our Act is that there are additional provisions with respect to how the information can be handled under the Canada Consumer Product Safety Act.
And so we do have the ability to disclose to a person or government that carries out a function that relates to the protection of health and safety without the consent of an individual as it relates to personal information where it's necessary to identify or to address a serious danger to human health or safety. So there has to be a serious danger to human health or safety and that information has to be necessary in order to deal with that serious danger to human health or safety. So we do have the ability there to issue without consent in that very exceptional circumstance.
With respect to confidential business information we have the ability to disclose confidential business information in relation to a consumer product without the consent of the person to whom the business information or affairs relates without notifying them beforehand in two specific circumstances: - where the disclosure is to a person or government that carries out functions relating to the protection of human health or safety or the environment and that person or government that we want to share the information with -- that we want to disclose the information to, that they agree in writing to maintain the confidentiality of this information and to use it only for the sole purpose of carrying out the functions that I just described; - the other place where we can do it is where the disclosure is essential to address a serious and imminent danger to human health or safety or the environment and the disclosure is essential to address the danger, and in that case we have to notify the person to whom the confidential business information relates the day after, so the next business day we have to advise you that that information has been disclosed.
So again, as I mentioned, none of these provisions affect the provisions that are under the Access to Information Act nor the Protection to Privacy Act, and we do treat confidential business information and personal information in an appropriate fashion.
I just want to highlight very briefly what we see in terms of compliance and enforcement under the Act. So there are new powers under the Canada Consumer Product Safety Act to help verify and deal with compliance and help prevent non-compliance. The fines have been increased. So for a summary conviction, the maximum fine for a first offence is $250,000 and $500,000 for a subsequent offence. For a conviction with indictment, the maximum fine is $5 million. There are also provisions for administrative monetary penalties.
I mentioned to you earlier the administrative monetary penalties relate to an order that's been issued under the Act. If you're in non-compliance with your order, you would get a notice of violation issued, and once the administrative monetary penalty scheme is in place, it also will identify what the fine is associated with that specific type of non-compliance. So this provision has to be put in place through a regulation. We will be moving to put a draft regulatory proposal in Canada Gazette later on this fall or early winter. We did consult on it earlier on and we're looking to move that forward.
So again, if you're interested in the considerations of what will be found in that administrative monetary penalty scheme, then I suggest again that you sign up for our Web service and pay attention to the notifications with respect to that. And the penalties that can be imposed under the AMPs: - a maximum fine of $5,000 for not-for-profit organization; and - $25,000 for any commercial organization. But what you will see in the regulation is actually sort of like a type of schedule. Depending on the nature of the violation, how often it's happened and so on, there will be a series of different fines that can be applied. So it essentially puts in place a ticketing regime to deal with violations of orders.
So those are just some of the new compliance and enforcement tools, but as I mentioned, we expect that the vast majority of the situations that we face will continue to be dealt with by our responsible industry and done so in a voluntary and cooperative fashion.
So I want to conclude today's presentation and just talk briefly about what has been going on in terms of our national outreach campaign. So we have been actively spending time and energy getting out to people, trying to let them know about the new requirements. We engaged in, before the Act came into force, in terms of getting people's insight and ideas about how we can help guide and provide appropriate information for mandatory reporting, for document retention, for a quick reference guide in terms of what we see under the Act -- and all of those tools are available online -- and we had great assistance and collaboration from industry.
We've been holding sessions across Canada in advance of the coming into force on June 20th and they continued throughout the summer. We also have been doing a series of webinars such as the one that you see today. This webinar will be posted online as well. So for those that can't come in person to events or haven't participated directly with the webinar, they can also go online and view them that way.
We've also put a bunch of other information out there. There have been national ad campaigns that have happened. We've been collaborating quite extensively with industry and have regional inspectors going out to deal with industry and holding industry-specific exchanges around what's required under the new Act.
We've also been collaborating with industry and industry associations to hold specific webinars, and if there are people who still feel they need that, we are more than happy to engage directly with them and to have a more elaborate discussion with respect to that. We've also been going out to speak at other events and we're very receptive to people's feedback and ideas about what they think is needed in terms of ensuring that we get the message out to people, because this is definitely our period where we want to ensure that people understand what their new obligations are.
And we want to see these provisions take effect and we want to see the mandatory reports come in and we want to see the actions being taken by industry and we really like to be aware of what they are and how that's working out. And we also really want to ensure that people understand their new obligations. So we're going to continue to hold those kinds of sessions. We are going to continue to build on and strengthen the collaboration that we've had with industry, and so your feedback and comments are important to us.