:
Mr. Chairman, the scientific approach we use to protect human health has two main components; one identifies potential health effects and the other identifies exposure, of specific interest today, through the ingestion of pesticide residues on food. Together these two components are used to identify potential risks to human health and what is required to protect people from those risks.
[English]
Pesticides are stringently regulated in Canada according to modern internationally recognized scientific risk assessment methods before they are approved for use or sale in Canada. The scientific methodology used to set maximum residue limits on food is well established internationally.
Maximum residue limits are set in Canada's food and drug regulations as the maximum level of pesticide residue permitted on domestic and imported food. Health Canada establishes maximum residue limits as part of the extensive assessments conducted on each pesticide product before it is registered for use in Canada. In fact, maximum residue limits are set for each pesticide and food crop combination.
Maximum residue limits represent the maximum residues expected to be left on food at harvest at the approved application rate. They are established only after a dietary risk assessment has confirmed that any pesticide residues likely to remain on food when it is eaten will not pose health concerns for anyone.
Health Canada pays special attention to ensure that people who are more sensitive, such as children, pregnant women, and seniors, are not at risk. In other words, the exposure to pesticide residues through consumption of food over a lifetime must be lower than the exposure that is determined to be acceptable.
It is important to note that maximum residue limits do not represent limits above which residues may be harmful to humans. The actual human health standard is the acceptable daily intake, which has already been determined as the amount of pesticide that can be consumed each day without risk for an entire lifetime.
On the other hand, maximum residue limits do act as a trigger for further evaluation if they are exceeded. If a food has a residue level higher than that of the established maximum residue limit, our colleagues, the Canadian Food Inspection Agency, would notify us if they felt there were any health concern.
Dr. Richard Aucoin will now discuss the international context for pesticide regulation.
Thank you.
:
Mr. Chair, Health Canada has been working for more than ten years with its counterparts in other countries, such as the European Union, Australia, New Zealand, Japan, and the United States, toward greater cooperation in pesticide regulation.
By cooperating internationally, Canada and its partners can achieve many benefits. Most importantly, this cooperation allows regulators to stay abreast of advances in science and develop regulatory approaches to achieve the highest standards for protection of human health and the environment. It allows regulators to gain efficiencies from sharing the work in reviewing new pesticides and reassessing older ones. For the agricultural sector, benefits include reduced barriers to trade in food, greater access to newer and safer pesticides, and enhanced competitiveness.
Mr. Chair, I would like to emphasize that the protection of human health is the highest priority we have. However, while international cooperation in pesticide regulation has led to a convergence in regulatory approaches, it's important to emphasize that Canada makes its own independent regulatory decisions in accordance with domestic legislation and in full consultation with the Canadian public.
[Translation]
Over the years, some have expressed concerns that these efforts led to the lowering of national standards. This has not proven to be the case. Our efforts toward international regulatory cooperation have allowed Canada to adopt higher standards for pesticide regulation.
For example, when the US Food Quality Protection Act of 1996 was enacted, it required the US Environmental Protection Agency to evaluate the cumulative effects of pesticides with a common mode of action and to consider sensitive populations, such as children, pregnant women and seniors in human health risk assessments.
At that time, Health Canada worked closely with our counterparts in the US Environmental Protection Agency to employ this higher standard for protecting human health in Canada through policy changes. With the coming into force of the Pest Control Products Act last June, these standards are now law in Canada.
[English]
Another example of raising standards is found in Health Canada's current proposal to revoke the default maximum residue limit of 0.1 parts per million in favour of establishing specific maximum residue limits for domestic and imported food, as is done in the United States. The general maximum residue limit allowed food to cross the border if it had a pesticide residue of less than 0.1 parts per million, yet no specific maximum residue limit existed. By revoking the general maximum residue limit, all maximum residue limits in Canada will be set according to the scientific risk assessment process described earlier by my colleague. This means that the maximum residue limits specific to each pesticide will be more protected of human health.
With respect to Canadian maximum residue limits for pesticides on food, none have been changed to date. At this time, Canada is discussing the possibility of harmonizing maximum residue limits with its international partners. If Canada deems that changing a maximum residue limit is in its interest, it will be changed only if it meets strict health protection standards and only after consulting with Canadians. Health Canada's priorities are the health and safety of Canadians and their food supply. This is a guiding principle when regulating pesticide use in Canada.
In summary, Mr. Chair, the protection of the health of Canadians is paramount. International regulatory cooperation does offer benefits but not at the risk of Canadians' health. Our high standards and priorities for human protection will not change as a result of discussions regarding the possibility of enhanced cooperation.
Thank you.
I would like to thank the committee for the opportunity to speak to regulatory changes being contemplated by the Hazardous Materials Information Review Commission. In fact, the commission has recently finalized draft amendments, two regulations that are consequential to what is now known as chapter 7 of the Statutes of Canada, 2007, formally known and presented to this committee in January as Bill .
As vice-president of corporate services and adjudication of the Hazardous Materials Information Review Commission, I have the responsibility for the development of both regulatory and legislative policy.
[Translation]
I would like to provide you with a brief overview of the Commission and the proposed regulatory amendments, after which we will be happy to take your questions.
[English]
I will give a brief overview of the role of the commission--you may recall I spoke of this earlier. It is to manage the trade secret component of the workplace hazardous materials information system, commonly known as WHMIS, or SIMDUT. WHMIS is a federal, provincial, and territorial hazard communication system established in the late 1980s through a consensus of industry, organized labour, and the federal, provincial, and territorial governments.
Among other things, WHMIS requires that product labels and safety documentation fully disclose the identity of hazardous ingredients within a product, the specific hazards posed by the product, the precautions to be taken in handling the product, and first aid measures to be applied in the event of exposure. The goal of WHMIS is to ensure that workers using hazardous materials have the information they need to minimize the risk of illness and injury.
HMIRC operates as a quasi-judicial independent agency with a mandate to grant exemptions from the full disclosure requirements of WHMIS while ensuring that the documentation on the safe use of the products is provided to Canadian workers and is accurate and complete.
[Translation]
The Commission's role is a dual one as it ensures a balance between workers' right to know what is in the products they work with and their hazards, and the industry's right to protect its trade secrets. The activities of the Commission can be broken down into three key components of our mandate.
[English]
First, we conduct an economic analysis to determine whether the claimant's information is truly a trade secret and whether disclosure will have economic consequences. Second, we conduct a scientific analysis to ensure that the health and safety information being supplied to employers and workers about the product is accurate and complete. The third part of our mandate is the administration of an appeals process. When a claimant or any affected party, such as a worker representative, challenges a decision of our commission, an independent appeal board is appointed to hear that challenge.
The governance of our commission is unique in the sense that the oversight of this three-part mandate is provided by a council of governors. On this 18-member council there are two representatives of workers, one representative of employers, another representative of the suppliers who supply the materials into the workplaces, and every province and territory has a member on this council, including a representative of the federal minister responsible for occupational health and safety.
Under our act the council has the statutory mandate to make recommendations to the minister on procedures for reviewing claims, appeal procedures, changes in fees and other related matters, and regulatory changes. The regulatory amendments we are currently proposing were developed under the aegis of this council as the means to deliver on commitments made to stakeholders as provided for in chapter 7. As did Bill , the regulatory proposals have the unanimous support of our stakeholders as represented on our council of governors.
[Translation]
I would now like to turn to the issue that brings us here today, the proposed regulatory amendments consequential to Chapter 7 of the Statutes of Canada 2007.
The last time I had the pleasure of addressing this committee was regarding the legislative amendments to the Hazardous Materials Information Review Act set out in Bill . The Bill received the unanimous support of this Committee and was reported back to the House of Commons for Third Reading where it received the unanimous support of all parties and received Royal Assent on March 29, 2007. At this point, the Bill became law as Chapter 7 of the Statutes of Canada 2007.
[English]
I would like to briefly review the legislative amendments, because there is a strong link between the legislative amendments and the regulatory amendments: one, allow a claimant to make a declaration that the information for which protection from disclosure is sought is a trade secret and that substantiating information is available upon request; two, allow a claimant to enter into an undertaking with the commission to voluntarily correct the health and safety information without a formal order; and three, allow the commission to provide factual information to appeal boards upon request.
These amendments, you may recall, were designed to reduce the administrative burden both on the claimants that come to the commission and on the commission staff itself, to speed up the correction of information that is required to get to workers concerning the health and safety information, and to expedite the appeals process.
[Translation]
However, in order for these changes to be fully implemented certain regulatory amendments are also required. The proposed regulatory amendments touch each of the Commission's three area of activity.
[English]
In terms of the first regulatory amendment regarding the information required to substantiate a claim—we're talking about the economic analysis side of our commission—under the declaration approach introduced by chapter 7, claimants declare that the information for which they are seeking exemption, the trade secret, is in fact a trade secret, and they provide a summary of the supporting documentation. However, the commission will require full documentation in support of a claim in the following instances: one, when an affected party challenges or makes a submission to the commission; two, when the claimant's declaration has been selected as part of a verification scheme; or three, when the screening officer within the commission has reason to believe the information may not be accurate.
The regulatory amendment outlines the basic information that will be required in a claim for exemption using this declaration approach, in addition to the detailed information that some claimants will be required to provide when their claim is selected for verification.
So the regulations spell out, one, that there's a basic new claim for exemption using a declaration approach, and two, that there's a second claim for exemption approach that requires full documentation.
[Translation]
Under this verification process, Screening Officers will be able to verify that the information provided by claimants with their declaration is accurate, and ensure there are no frivolous or false claims.
I will not outline the amendments related to the Commission's review of health and safety information provided by claimants.
You will recall that the second amendment to the Act allowed for the voluntary correction of safety documentation by claimants. Allowing corrections to be made voluntarily will expedite the process of getting complete and accurate information into the hands of workers, because the corrected information will be available immediately upon correction, rather than having to wait until after the publication of orders and subsequent appeal period expires at which point the correction orders become binding.
[English]
To ensure the transparency and openness of this process, we're proposing two regulatory amendments. The first, in the interests of transparency, proposes to publish the content of these compliance undertakings in the Gazette with a link from our website. This way the workers will know exactly what information has already been corrected, and in this way it provides them access to the corrected information and allows them to verify that this corrected information is actually available in the workplace.
The second amendment allows for the appeal of these compliance undertakings by affected parties to allow for recourse if the affected parties challenge the undertaking.
It's important to note here, and it was mentioned again when we talked about Bill S-2, that a formal correction order will always be issued if the claimant chooses not to make the corrections or if the undertaking has not been made to the satisfaction of the screening officer; in other words, full compliance will be realized in any case.
Turning to the appeals process, again, chapter 7 allows for the commission to provide factual clarification of the record of the screening officer to appeal boards when it's needed to facilitate the process.
[Translation]
Appeals are heard by independent boards with three members drawn from industry, labour and the chair of the appeal board, representing government. Most, if not all, appeals heard to date by the Commission's appeal boards would have benefited from additional explanatory information from the Commission, but this was not permitted under previous legislation.
[English]
The proposed regulatory amendments regarding the appeals process outline the process by which a party to an appeal may make a request for such clarification from the commission. This request requires unanimous support from the appeal board, and, if supported, the commission will be required to provide the appeal board with a written response.
In addition, the proposed amendments also allow for an appearance by the commission. In this case, it would be where the commission's written response already provided requires further clarification or, due to the urgency of the matter, if an appearance by a commission official would better aid the resolution of these issues.
None of this will interfere with the statutory independence of these independent appeal boards, as this is absolutely essential for the acceptance of appeal board decisions.
There are other housekeeping amendments.
[Translation]
There are additional proposed amendments to the regulations that are not related to Chapter 7. Among these amendments are wording updates, including those required to comply with the Bill to Modernize the Statutes of Canada, provisions to permit the electronic filing of claims, and minor amendments to streamline the appeal process.
[English]
In conclusion, I'd like to re-emphasize that the commission's regulatory changes have been developed in the same manner as Bill , through extensive consultation with our stakeholders, consultations that commenced several years ago at the time the legislative amendments were being developed. Unanimous support for these regulatory amendments was most recently received from the commission's council of governors, literally last Friday at our annual council of governors meeting. Again, council of governors represent all of our stakeholders--labour, industry, employers, and each province and territory, as well as the federal government. At that meeting, our stakeholders' message was quite clear: these regulatory amendments are an extension of Bill S-2, which received unanimous support from our stakeholders and unanimous support from this committee and from all parties.
These amendments do not compromise worker health and safety. They will reduce the time to review economic information in support of claims; they will allow efficiency gains to be reinvested into the health and safety side of our business; and, when implemented, they will speed up the correction of health and safety information that needs to get into the hands of workers.
We feel these changes are a positive step forward for workplace health and safety in Canada. Thank you very much.
:
Thank you for the question. This gives me the opportunity to try to explain something in a more condensed manner. It is a very complicated issue, so I will try to explain that quickly.
In doing a dietary risk assessment, as I mentioned in my presentation, there are usually two main areas we look at. One is the exposure. In this case we are talking about the residue that remains on the food. When we do the exposure assessment, we include all the populations--including children, seniors, pregnant women--according to their dietary intake: what their dietary behaviour will be, what types of foods they will be taking, and so on and so forth, in doing the exposure assessment for the rarest age group. So that's one part of the risk assessment.
The other part of the risk assessment, as I mentioned, is to look at the potential toxicity studies to identify if there is any potential health concern of somebody being exposed to that particular pesticide product. Once we identify from the toxicology database, we will look at what is considered to be an acceptable daily intake, which in layman's language is that when somebody is ingesting or consuming certain products that contain that residue for the whole duration of their lifetime, it is considered to be acceptable or doesn't pose any health concern. So in that sense, we're looking at the hazard associated or the potential health concern, if any, for somebody exposed to that chemical versus the exposure from the residues that are from the food or from the crops, whatever the people are ingesting.
So when we compare the two, we look at what are the differences, what are the comfort levels, if that's the right word. If we determine that at a certain level there's no health concern, and then the exposure scenario is well below that, then we would say that is an acceptable residue in the food consumption.
So tying it back to the questions that PMRA would identify if there is any health concern or not, when they refer that to us, we immediately look at doing the dietary assessment of that particular reference. Depending on how much data we have on hand, it could be a process that's very quick, because we already have all the information and we can do the assessment and so on, or it could be a longer process. If we don't have all the data, we'll have to gather all the data information to look at comparing the exposure from this particular residue versus what we consider the acceptable daily intake for that chemical or pesticide.
So when we compare the two, if it's considered acceptable, there will be no health concern for that.
:
Thank you for the question.
Right now, interestingly, there is an initiative called GHS, globally harmonized system, which is an initiative to look at harmonizing chemical classification and labelling. In that respect, the United Nations has sponsored this event and this initiative. The country that is participating in that would be the United States.
If we look at the United States' system in comparison to ours, in terms of trade secret protection and disclosure of ingredients on products, they have a system that is not comparable at all in the sense that their system for trade secret protection relies on a challenge basis. In other words, if you're a supplier in the U.S. market and you believe you have a trade secret, you claim that you do, and you only have to prove it upon a challenge by an affected party, usually in the courts.
In Australia, another country that has an ingredient disclosure system, you cannot claim trade secrecy for certain types of hazards, like carcinogenicity, but there is no systemic review of safety documentation as there is in the Canadian system.
In the EC countries right now there's a new initiative called REACH, which is also looking at some sort of a trade secret mechanism. Again, it's not quite as stringent as the Canadian model. It's looking at certain kinds of hazards that one cannot claim exemption from, but, again, there's no systemic review of all of the safety documentation that goes with a claim for exemption, such as in our case.
What has happened under GHS is that they've looked at the trade secret mechanisms around the world. The Canadian contingent very strongly supports the Canadian model. In fact, the labour representatives on our council who we met with last week were at those meetings in Geneva and spoke to the Canadian system as being an international model.
They have very clearly established broad principles to which all countries must conform, but which allow the Canadian system to remain as stringent as it is, and in fact unique.
So in terms of harmonization, there is actually no effort to harmonize the trade secret mechanisms.
:
Thank you for the question.
When we use the animal models, in a lot of cases, to do what we call hazard identification, it's basically an internationally recognized standard, as I mentioned earlier. There are specific guidelines and interpretations that are internationally recognized by all the various countries, including the EU, Australia, and so on.
When we expose animals to certain chemicals and ask how is that going to be related to humans—and I agree with you—what we do is take the precautionary approach, and we actually apply what we call the uncertainty factor, or safety factors, which means we are not sure; therefore, we build in a certain margin of error or margin of translation from animal to human. So that builds in that so-called uncertainty in linking it from animal data, then, to the human environment. That is usually a factor of about 100 times, just to build in that uncertainty or that precautionary approach that we take.
Secondly, when we look at the risk assessment or the hazard identification, we also look at the end point or the level at which there is a certain effect being observed in animals or in rats. Also, as I mentioned, it's not only dealing with just one species. We look at more than one species. For example, we could do it in rats; we could do it in mice, or sometimes in dogs. So we look at the variability among the various species as well in the pre-market scenario.
From that we look at whether there is any concern about the age variation within the lifetime of the animals. Is there something that's more sensitive or obvious for the older animals? Is there anything of concern when they are reaching the later stage of their lifetime, or for pregnant women, and so on and so forth? When we identify those potential health concerns, we tack on another uncertainty factor of margin of safety, which is the margin where we say, okay, in order to be protective—that is, applying the precautionary approach again—we tack another uncertainty factor onto that.
By accumulating all this uncertainty, or the safety margin, if we want to call it that, including what we call the entire species in the sense that animal to human may be different, and when we talk about intra-species, within a population, let's say within the human populations, because of the various ages, races, and all that sort of stuff, there may be variability, so we apply that protective factor in addition to that.
By doing all this, we actually build in enough of what we call the margin of safety, but you can call it a margin of uncertainty, taking the precautionary approach to build in that comfort zone in order to develop what we call the acceptable daily intake.