Proceedings of the Standing Senate Committee on
Agriculture and Forestry
Issue No. 67 - Evidence - Meeting of May 28, 2019
OTTAWA, Tuesday, May 28, 2019
The Standing Senate Committee on Agriculture and Forestry met this day at 5:52 p.m. to study the subject matter of those elements contained in Subdivision C of Division 9 of Part 4, insofar as it relates to food, and in Subdivision J of Division 9 of Part 4 of Bill C-97, An Act to implement certain provisions of the budget tabled in Parliament on March 19, 2019 and other measures.
Senator Diane F. Griffin (Chair) in the chair.
[English]
The Chair: Welcome. I’m Senator Diane Griffin from Prince Edward Island and chair of the committee. This evening, the committee is going to begin its pre-study of the subject matter of those elements contained in Subdivision C of Division 9 of Part 4, insofar as it relates to food, and in the Subdivision J of Division 9 of Part 4 of Bill C-97, An Act to implement certain provisions of the budget tabled in Parliament on March 19, 2019 and other measures.
For this meeting, we will be concentrating on Subdivision J of Division 9 of Part 4. That is, amendments to the Pest Control Products Act. Before we hear from the witnesses, I would like to start by asking the senators to introduce themselves.
Senator Doyle: Norman Doyle, Newfoundland and Labrador.
Senator Bernard: Wanda Thomas Bernard, Nova Scotia.
Senator Kutcher: Stan Kutcher, Nova Scotia.
Senator Moodie: Rosemary Moodie, Ontario.
Senator R. Black: Rob Black, Ontario.
Senator C. Deacon: Colin Deacon, Nova Scotia.
The Chair: As you know, we were late because of a vote and we may be shortening up in terms of the questions people will ask, but hopefully it doesn’t shorten your presentations on you.
From the Grain Growers of Canada, we have Jeff Nielsen, President; from the Canadian Federation of Agriculture, Frank Annau, Environment and Science Policy Advisor; and from CropLife Canada we have Dennis Prouse, Vice-President, Government Affairs.
Thank you for accepting our invitation to be here. We will start with Mr. Nielsen.
Jeff Nielsen, President, Grain Growers of Canada: Thank you for allowing me to share with you the views of the members of the Grain Growers of Canada. As you mentioned, it’s a long version of what we’re studying tonight.
I’m Jeff Nielsen, chair of the Grain Growers of Canada. I have a farm north of Olds, Alberta. Grain Growers of Canada is a national grain and oilseed organization representing 65,000 grain, pulse and oilseed farmers from every province. What the majority of members grow is sold to customers around the world. Ensuring that we remain competitive not global marketplace is critically important if we want to realize the full growth potential of our sector and meet the ambitious target set out by the Economic Strategy Tables report released this past winter.
The report suggests that under an agile regulatory system, one that supports innovation and provides certainty to the industry, Canada’s agri-food sector could easily increase from $64 billion to $85 billion by 2025.
That is why our members were encouraged to see that in support of the government’s regulatory modernization efforts, Bill C-97 proposes changes to the Pest Control Products Act. Under the current act, Canada’s health minister is obligated to initiate a special review of pesticides active ingredient any time an OECD country has banned its use. While this may make sense on the surface, there are two important considerations to keep in mind. As it is currently written in the act, a special review would be required regardless of the timing of the active ingredient’s last review. This would apply even if the active ingredient was currently under re-evaluation or had been recently reviewed.
The change that is proposed in Bill C-97 under Subdivision J of Division 9 of Part 4 would give the health minister flexibility to determine if a special review is necessary. It also allows the minister to consolidate related special reviews. This would have been helpful in the case of neonicotinoids. Since 2016, neonicotinoids have been the subject of 10 proposed decisions and five separate re-evaluations, including 15-year cyclical re-evaluation, pollinator-specific re-evaluations, a special review related to squash bees and a special review to related aquatic invertebrates.
In addition to timing consideration, it is also important to recognize that not every OECD country employs the same scientific approach to assessment of active ingredients in pesticides. In Canada, for example, as in many countries around the world, Health Canada employs a risk-based approach. According to the Pest Management Regulatory Agency, or PMRA, the use of risk-based approach is consistent with approaches for regulation of other chemicals in Health Canada. The framework provides a systemic application of science to support the PMRA’s regulatory decisions. It also enhances predictability, transparency and the process that protects the health of Canadian in our environment.
Canada therefore should not be under any obligation to undertake a special review in response to an outcome arrived by a country employing a different assessment approach. It is important to note that Subdivision J of Division 9 of Part 4 of Bill C-97 does not eliminate the opportunity for the minister to undertake a special review. It simply affords Canada’s Minister of Health the flexibility to determine whether a special review is, in fact, warranted. Nor does it change the fact that the PMRA will continue to be required to re-evaluate active ingredients every 15 years regardless of the degree of risk.
We are not alone in calling for this change. In response to the 2015 consultation launched by PMRA, Grain Growers, along with the industry partners called for a reduction of the number of automatic, non-risk-based reviews and re-evaluations.
In a paper prepared by the Canada Grains Council, of which we are members, the submission focused on the role of PMRA in support of innovation. It included a total of seven recommendations.
I will note them:
1. Early consultation of the stakeholders by PMRA;
2. The creation of additional data for re-evaluations, including establishment of a national water monitoring program;
3. A reduction of the number of automatic non-risk-based special reviews or re-evaluations;
4. The inclusion of risk benefit analysis as part of re-evaluations;
5. Additional consultation on end points, including regulatory alignment, with the U.S. Environmental Protection Agency, the federal body that the U.S. uses to evaluate and regulate their pesticides;
6. An increase in PMRA’s resources for compliance with the international trade and Codex Maximum Residue Limits or MRLs; and importantly,
7. Regulatory cooperation and clear communication across governments.
Only one of those seven sector-supported recommendations has been addressed since the Canada Grains Council submission in 2018. Grain Growers of Canada remains hopeful that the balance will be addressed as part of the Agri-Food and Aquaculture Roadmap, a commitment the federal government outlined in the 2019 budget. Grain Growers look forward to participating in the related process that seeks to develop proposals for legislative and regulatory amendments, novel regulatory approaches to accommodate emerging technologies, including the use of regulatory sandboxes and pilot projects.
Grain Growers Canada supports a rigorous, evidence-based regulatory approach that protects human health and the environment, enables access to crop protection and products and supports our competitiveness as grain farmers. Our members are in favour of this amendment being proposed under Division 9 because it is a step in the right direction to ensuring that PMRA’s limited resources are focused on where they most need to be: protecting the health and well-being of consumers as well as the farmers like me who use the products.
Once again, thank you for the opportunity to speak with you today.
The Chair: Thank you. Mr. Annau, please go ahead.
Frank Annau, Environment and Science Policy Advisor, Canadian Federation of Agriculture: Madam Chair and committee members, thank you for the opportunity to present the Canadian Federation of Agriculture’s perspectives on Bill C-97.
CFA is Canada’s largest general farm organization, and our members include provincial farm organizations and national commodity groups across Canada. Through our members, we represent over 200,000 farmers and farm families nationwide.
CFA welcomes amendments to the Pest Control Products Act under Subdivision J of Division 9 of Part 4 of Bill C-97. These amendments will allow the Minister of Health to expand the scope of re-evaluation or special review of the pest control product rather than initiate a new special review. The amendments would also allow the minister to decide not to initiate a special review if a product is under re-evaluation or special review. These amendments would help address agricultural stakeholders’ concern over duplication in the re-evaluation and the special review processes. As the act currently stands, the minister must initiate a special review when an OECD country prohibits the use of a pest control product’s active ingredients, even if that product is already under re-evaluation in Canada.
There is concern that this duplication is taking up valuable resources within the Pest Management Regulatory Agency, or PMRA, at a time when PMRA is taking effort to modernize their review process. As such, allowing the minister this discretion has the potential to free up critical capacity within the PMRA and help realize their goal of carrying out a more efficient regulatory regime.
This also presents a fantastic opportunity for PMRA to reallocate the resources needed to fully engage with Canadian agriculture on improving pest control products review processes. Our recommended improvements include ensuring that actual information on a product’s social and economic impacts is provided to the minister upon initiation of a review, as required under the Pest Control Products Act, and most critically, that PMRA may finally address farmers’ long-standing requests that field data showing reduced risks from use of pesticides be allowed to be submitted during a review’s scientific assessment phase. Currently, only data showing increased can be submitted during this phase, and farmers are eager to provide PMRA with the up-to-date scientific information out in the field.
In closing, an efficient regulatory regime is needed to preventing unacceptable risks to the environments and individuals from the use of pest control products. We believe that Bill C-97’s proposed amendments will facilitate this efficiency by reducing duplication in pest product reviews.
CFA would like to thank this committee for receiving our request to review these amendments proposed for Bill C-97. We would also like to thank PMRA for including us on consultations on the re-evaluation program review. We are confident that their work will be greatly bolstered by the proposed amendments to the Pest Control Products Act under Subdivision J of Division 9 of Part 4 of Bill C-97. As such, these amendments have our support. Thank you for listening today. If you have any questions, I’m happy to answer them.
The Chair: Thank you. Mr. Prouse, please go ahead.
Dennis Prouse, Vice-President, Government Affairs, CropLife Canada: Thank you, Madam Chair and honourable senators. CropLife Canada represents the Canadian manufacturers, developers and distributors of pest control and modern plant-breeding products. Our organization’s primary focus is on providing tools to help farmers be more productive and sustainable, and we also develop products for use in urban green spaces, public health settings and transportation corridors.
We are here today to speak in support of Bill C-97 due to the fact it makes an important start down the road of regulatory modernization.
As we know, from the Advisory Council on Economic Growth, often known as the Barton report, and the Agri-food Economic Strategy Tables, Canada must overcome internal barriers that hinder innovation and competitiveness if we are to meet the government’s target of $75 billion in agri-food exports by 2025.
Bill C-97 takes significant actions to address regulatory modernization. In particular, it makes key amendments to the Pest Control Products Act to help alleviate resource pressures on Health Canada’s Pest Management Regulatory Agency, and allows it to focus on work that meaningfully contributes to the agency’s mandate.
The current requirement in section 17 of the Pest Control Products Act requires the Minister of Health to initiate a special review of any pesticide for which an OECD country bans all uses of the active ingredient. The language gives no discretion to the minister to determine whether a special review is necessary. An active ingredient that is currently under re-evaluation or had just been reviewed can still be subject to a new special review.
Certain special interest groups have learned to exploit the current system, and the owner of special reviews coupled with challenging with the current re-evaluation process are contributing to the PMRA’s unsustainable workload. These duplicative efforts only serve to bog down the system, and they prevent farmers from having access to the tools they need to protect their crops and help drive Canada’s economy.
Under Bill C-97, the Pest Control Products Act would be amended to give the Minister of Health discretion to move forward with a special review only when it stands to serve the best interests of Canadians. It also allows the minister to consolidate related special reviews, which would fix the tsunami effect that might otherwise result.
We applaud the efforts of the bill to address regulatory modernization, but it is only one part of a much broader set of improvements that are needed. For instance, we continue to press for critical improvements that can and need to be made to PMRA’s re-evaluation process under existing authorities, as these have not yet been addressed. Similarly, we are seeking formal cabinet-level acknowledgment of the economic role that both the PMRA and the CFIA play in facilitating agriculture’s and agri-food’s economic growth.
On the CFIA side, the agency has still not yet clarified their regulatory oversight for products with gene editing. Gene editing is poised to transform agriculture around the globe. Despite this, Canada is falling behind some of its global competitors that are acting decisively on creating timely, predictive approaches to regulatory oversight to products of gene editing.
Examples, like this, are why the government needs to act quickly on the concept articulated in Budget 2019 of placing a competitiveness lens on regulatory agencies. Competitiveness does not come at the expense of health and safety, which must always remain at the forefront. What it does mean is that regulators acknowledge and embrace their role in helping to facilitate innovation and competitiveness for Canadian companies, all while maintaining their focus on science-based regulation.
Action is also required for the annual regulatory modernization bill, also outlined in budget 2019. The new External Advisory Committee on Regulatory Competitiveness will no doubt have some strong content for that bill.
It is encouraging to see momentum building around modernization that will serve to drive growth in Canadian agriculture and the economy writ large. Regulatory modernization must be a whole-of-government exercise and led by key economic players; namely, the Department of Finance and Treasury Board. Regulatory agencies do not reform themselves. They respond only to strong direction and leadership from above. Absent that, regulatory modernization will slowly lose momentum and collapse. Given the promise held by the economic growth in Canadian agriculture and agri-food, that would be a tragic development.
Thank you, Madam Chair. We look forward to any questions committee members might have.
The Chair: Okay. Thank you. We will begin questions, then.
Senator Doyle: On pest control part and the special reviews, what sort of information would have to become available to trigger Health Canada to start a special review of a pest control product? Would it be media coming out with health dangers and that kind of thing, or is it something you would find through your own investigation of the pest product?
Mr. Prouse: Senator, I’ll start and I’m sure my learned colleagues here will be able to add in.
One of the things that could start a special review, for instance, as mentioned, is if another OECD country bans an active. A country like Norway, for instance, could choose to ban a product and under the current act that would compel Canada to open a special review. Not suggest. It would compel.
Upcoming in the next few years, because Europe has a hazard-based system as opposed to a risk-based system that we have, we’re anticipating that there might be upwards of 60 active ingredients banned by some European countries. That would, absent this amendment we’re talking about today, compel PMRA to undertake about 60 reviews. The threshold for triggering a special review is exceptionally low. That’s part of what we’re speaking to today. I’m sure Jeff has some other things to add.
Mr. Nielsen: Thank you for that. What I can add — and it’s something that we can ask later on. In the second or third part of today’s session there are two speakers from PMRA here. I look forward to them giving some of the information. What worries me, when you have special reviews coming in, as I mentioned, it adds more workload to them. Currently — I look to them to correct me — they are already backlogged as it is. That puts at risk products that farmers could be using or the chance of us losing a product due to the fact that review hasn’t been done yet. We’re limited in what tools we have as producers in the toolbox as it is.
To have another country that doesn’t follow some of the highest standards we have here with PMRA challenging some of the products we can use, I find that a risk.
Mr. Annau: PMRA mentioned during their December consultations with CFA that they anticipate initiating 145 new re-evaluations in the next five years, which is double the number of initiations in the previous five-year period.
That on top of any actual special reviews that would be initiated from an OECD country could create a bit of a tsunami effect and take a lot of critical capacity that could otherwise be directed to helping to modernize the re-evaluation process.
Senator R. Black: I have a few short questions.
From my perspective, it makes sense. Is there any downside? You haven’t told us any. Is there any downside that you can see that you’d like to share with us? It makes sense.
Mr. Prouse: We certainly don’t see any. Obviously the agency can speak for themselves. I wouldn’t imagine that they do, either. They were well aware of these issues and had flagged them themselves.
Mr. Nielsen: I would say modernization is renewal, moving forward — not anybody’s desire.
Mr. Annau: I don’t see any downside with the proposed amendments in Bill C-97.
Senator R. Black: How long does a review take in general?
Mr. Prouse: How long should it take? How long does it take?
Senator R. Black: How long does it take now and that’s partly because of backup and backlog.
Mr. Annau: Speaking to re-evaluation, which is a bit analogous to special reviews, they could take two to four years depending on the complexity of the part of the special review.
Senator R. Black: Mr. Prouse, you mentioned that you were here to speak to Bill C-97, that it makes an important start down the road to regulatory modernization. Is it enough of a start? I know you’ve all said that it’s looking good, but is it enough of a start that we can springboard to the next steps?
Mr. Prouse: We certainly hope so. When I was speaking to the members of the other place, I beseeched them not to lose sight of the momentum that is currently in place. I’m told there’s an election coming up. It shocked me to learn that. But that this positive momentum might potentially be lost. There’s been some important promise, but now it needs to be turned into action. That competitiveness lens that has been talked about, to place that competitiveness lens on regulatory agencies, in our view that is absolutely critical. There are other industries that would come in and tell you the same thing. That needs to be acted on.
I could elaborate on the CFIA side on the biotechnology side but there’s a lot of progress that needs to be made. There’s been good recognition of that. There’s been discussion of what needs to be done. Now talk needs to be translated into action.
Mr. Annau: A quick comment on that. I fully agree. As a producer and as the challenges that we face and as the current government has proposed, increasing growth, we can’t get that growth unless we see modernization and improved regulations and growth in this sector.
If we are standing backwards, we’ll lose and we can’t afford that.
Senator R. Black: Thank you.
Senator C. Deacon: Thanks, witnesses, for being here.
I want to pick up on the competitiveness lens because one of the things that I have thought about is the non-tariff trade barrier issue and “brand Canada.” The opportunity for us to grow our high-value products, our commodity products, grow our market share globally I think is phenomenal. I look at that and I look at what happened with glyphosate in Italy and what it’s done to our durum wheat business there, and say that is a risk I want to manage. I want to manage our being locked out of markets because we are not doing a good enough job in regulating the products we use.
How much of a concern is that to you guys?
Mr. Prouse: The competitiveness lens is huge for us. The reason why is that at present that competitiveness element is not in the mandates of either PMRA or CFIA. They are strictly health and safety. When we talk about competitiveness and we talk about readying Canadian companies to compete around the world, not our mandate. Yet everything our member companies do must pass through the lens of either the PMRA or CFIA. Nothing we do can go without their regulatory approval.
When I talked about the whole-of-government approach, we have every other element of government talking in very positive enthusiastic terms about economic growth and about innovation in agriculture and then we reach Health Canada and it’s, “Sorry, not only can’t we consider economic considerations, we’re somewhat offended that you even raised them.”
This is why that competitiveness lens needs to be there. It doesn’t mean that health and safety takes a back seat. Science-based regulation is paramount. But I’m fully confident we can do both.
Senator C. Deacon: You don’t see a conflict there at all. You see putting that on there as a path to speeding things up? I’m worried about the two-to-four-year review time that Mr. Annau mentioned. What are the international benchmarks on that? How do we compare? Is everybody taking two to four years to complete these reviews?
Mr. Annau: Just to clarify, that would be specific to the re-evaluation process as opposed to specifically the special review process. But as I said, they are analogous in terms of how they are executed.
Specific to how we do compare internationally, unfortunately I don’t have the notes off-hand but that is a central component of PMRA’s current review of the re-evaluation process, sort of examining how we stack up internationally with nations like Australia, over in Europe as well.
Senator C. Deacon: If we look through a competitiveness lens and include a competitive lens in our evaluation, that’s got to be a factor.
Mr. Prouse: It isn’t at present. We were at the meeting of the Regulatory Cooperation Council in Washington, D.C. in early December and there were a number of stakeholders there. One of the questions that was asked of PMRA at the time is how we can get into alignment with the U.S. Environmental Protection Agency on approvals? We were told, under Canada’s current legislation, that’s not possible. We’re not able to get into alignment.
On day one we heard all of the political players, if you will, Canadian President of the Treasury Board, U.S. Director of Office of Management and Budget all talking enthusiastically about how regulatory cooperation can and should work together. On day two, we were told all the reasons why we couldn’t get into alignment. This in a nutshell is why we need that competitiveness lens.
Senator C. Deacon: Mr. Nielsen, to go back to the non-tariff trade barrier issue and the fact that part of your constituency is locked out of a major market globally because they’ve put up a barrier that may or may not be based on evidence. How are we managing that risk through the changes made here? What else could we do? What we’re trying to do is open up global markets, access global markets, be as competitive as possible globally with what we think is a phenomenal global high-quality product, safe and high-quality product.
Mr. Nielsen: That’s a very good point. Over 90 per cent of Canadian agriculture is dependent on trade. Ninety per cent of Canadians’ grain and oilseeds and pulses and all of that are exported, so it’s very key to us. We believe our science is the best science around, and as a producer and regulatory conditions that we do face now with the reforms coming, we see growth and better avenues for trade going forward. What we need to see is that these countries where we do import respect our regulations, our science. Technology today, you can find parts per billion, trillion or zillion in anything. If you want to throw up a non-trade barrier to anything you want, you could. But we kind of venture off to another topic when you expect your government and your trade ministers and your foreign affairs ministers to instill that the trade deals are followed.
Senator C. Deacon: If we’re looking at a competitiveness lens, we have to figure out how to solve that problem too, at some point, in some way, and make sure that our standards are as defensible amongst our global peers as possible.
Mr. Prouse: If I may, senator, one of the things we often talked about is us working with what I call the global coalition of the willing, which is all of the major ag exporting nations who all have a science-based regulatory system. We need to be working very closely with them internationally because as I often say, the list of countries that have science-based regulation and rules-based trade is a depressingly short one. Therefore, we need to be working very closely with those countries because they share our interests in defending against non-tariff trade barriers and non-science-based regulation.
Senator Moodie: Who are those countries that share?
Mr. Prouse: You find the large ag exporters in general are the United States, Argentina, Brazil, Australia. Whom did I miss?
Mr. Nielsen: The former Soviet Union.
Mr. Prouse: Ukraine.
Mr. Nielsen: Kazakhstan.
Mr. Prouse: Brazil and Argentina have rocketed forward in the last 15 years in terms of their agriculture exports. Not coincidentally, those are countries that are moving pretty aggressively on regulatory reform and on approving new trades very quickly.
The Chair: Before we go to second round, I have a couple of questions. Mr. Prouse, in your brief you indicated that Bill C-97, this section of it, is a good start but only a start. You had a couple of other suggestions. You indicated that you continue to press for critical improvements that can and need to be made to PMRA’s re-evaluation process under existing authorities as these have not been addressed.
Have you been given any reason why they’re not addressed, or is it simply lack of resources?
Mr. Prouse: There are a number of reasons why, including the lack of resources, the number of approvals that have come forward. The mandate and the legislation, they feel, has hamstrung them. This is why we think it’s fairly critical for them to have clear direction on a competitiveness lens and on how their mandate ought to be constructed.
We had concerns about how stakeholders were consulted during re-evaluation, the fact that some of those had stopped, the differences that you’re now seeing between interim decisions and final decisions. We think there’s a great deal of reforms that could be undertaken and would be helpful, which frankly don’t require legislative change. I think that overall competitiveness lens would go a great deal of distance to helping that.
The Chair: Your second point was that you’re seeking formal cabinet level acknowledgment of the economic role that both PMRA and Canadian Food Inspection Agency play in facilitating agriculture and agri-food economic growth.
What form would that take? I’m assuming the fact that these agencies are there and they are funded means that they must be recognized as playing a valuable role.
Mr. Prouse: Again, in Budget 2019, we started getting there because they talked about it. It was in the Fall Economic Statement as well, talking about placing that competitiveness lens on Canadian regulatory agencies. Once that’s actually in place, now you have that. Now you have a clear recognition that they have a competitiveness role and they have a competitiveness mandate. That’s what we’re looking for. It’s a whole-of-government approach that’s going to be needed if we want to hit $75 billion by 2025. It can’t be most of government, except for the regulatory agencies. It has to be a whole-of-government approach, so that’s what we’re talking about.
The Chair: Otherwise there’s a disconnect if the whole team isn’t on.
Mr. Prouse: Absolutely.
The Chair: Thank you.
Senator Doyle: On the special review you were talking about, by doing a review, you could trigger an investigation, you’re saying. If in the course of the investigation you discover, say, something new, another special review would be called for, would it not? Why not have a more comprehensive review to begin with? Would it save time? Would it save money? Is there a legal complication that would have to be looked at? Or am I out to lunch?
Mr. Annau: Definitely, it would be more from the purview of PMRA’s own processes. At the end of the day, it’s a matter of the amount of analysis it would take to critically evaluate any of the single ingredients specific to their own chemistries. This takes a certain amount of capacity and focus within the actual agency itself. I believe when other complications or risks are identified, specific to other ingredients within the actual product itself, that under these current circumstances it may trigger its own special review to focus those resources separately. Of course, what I believe the amendments are proposing would be, as you said, for the scope of the initial review to be expanded to identify and assess those new risks.
Mr. Prouse: I think it’s worth pointing out, senator, that the regular re-evaluation processes are very rigorous. Canada has one of the most respected regulatory agencies in the world as a result of that. They are mandated to look at all peer-reviewed evidence during those reviews. A special review should only be undertaken if there is compelling new evidence between the regular re-evaluation process that would compel them to act. We think that these amendments help PMRA do that and not have themselves be occupied with special reviews that are unnecessary.
Senator Doyle: Thank you.
Senator R. Black: Are those every 15 years?
Mr. Prouse: Correct.
Senator R. Black: Thank you.
Senator C. Deacon: I’m still on the 15-year issue. I’m on the fact that it takes two to four years for every review to be completed.
I got a sense from your presentations that you were concerned that the 15-year review was a burden. There has been, I think, a freeing up of a bit of capacity in these proposals. But it sounds like we are not getting to the heart of the issue, in terms of making sure that there’s enough capacity to complete these reviews in a timely basis. Do they take two to four years, or is it two to four years because we simply don’t have enough capacity?
Mr. Prouse: Senator, I think PMRA could probably speak to the resourcing issues. We’ve certainly made the case, and I know others have as well, that PMRA should have more resources to complete some of these reviews. Certainly some of the issues we’re seeing on re-evaluations could be addressed by that. I believe it was Mr. Annau who talked about the number of re-evaluations that are coming in the next decade, and PMRA has alluded to the fact that there is a large convergence of re-evaluations scheduled to come up.
We think the concept of re-evaluation is sound. Canadians need to have confidence in their system. They need to have confidence that the science is being reviewed regularly. We have no quarrel with that whatsoever. It’s just a matter of how those are done.
Senator C. Deacon: It’s that clarity.
Mr. Prouse: Are we sharing data effectively with other countries that have a science-based regulatory system? How are we conducting these? It’s a process issue
Senator C. Deacon: You see an opportunity potentially for international collaboration?
Mr. Prouse: They will do some of that now, but how much further down the road can they go on that, we certainly would like to see more.
Mr. Annau: There is definitely room for international collaboration. I believe there is a section of the act that does provide for it. One of the main barriers in place is that we do not have harmonized maximum limits with some of our bigger trading partners such as the United States.
Senator Moodie: Would you please slow down for me?
Mr. Annau: One of our major challenges would be that we currently do not have harmonized maximum residue limits with for example the United States. PMRA has recognized this harmonization as being definitely a potential benefit. With their directive — PMRA directive 9804 — it recognizes that harmonization with the United States would definitely be an added benefit in terms of even being able to analyze reports produced by the Environmental Protection Agency and seeing how they apply to Canada.
Senator Moodie: My question has to do with the standard that we’re going to end up with. I understand there is a difference between risk-based and hazard-based. I’m not sure I know exactly what that means. Is it more rigorous a process to be hazard-based or less rigorous a process?
Mr. Prouse: I have a poster and slide when I do PowerPoint presentations on the difference on this. Driving down the road is a hazard. There is a potential hazard. Driving down the road in a raging snowstorm is a risk.
What is the actual risk versus a hazard? The hazard would be more rigorous, but is it rigorous to an extreme?
Senator Moodie: That’s the question. When we shift and when we are saying that we have a risk-based approach, but we’re part of a group that every now and again would trigger based on a different set of standards, right?
Mr. Prouse: Correct.
Senator Moodie: I am quite focused on why we would want to drop to the lower standard and not take the trigger from one of these other countries. I accept that they have a different agri-industry and a different approach and maybe a lot less to lose, but I need to understand why we would drop to a lower level and think that will be a solution for moving us ahead? I hear you on capacity.
Mr. Prouse: Some of the bans that come from the European Union, in our view, are not based on good science. If that comes and a special review is triggered here, I don’t think that’s a good use of PMRA’s time and resources. I would also challenge anyone to show me that a hazard-based system has led to better environmental and health outcomes, because frankly we don’t see a connection.
We see a much stricter more bureaucratic system, but where is the evidence that has led to better health and safety environmental outcomes? We don’t see any.
Senator Moodie: My background is science. Is there science-based evidence of this? I know your opinion, but is there science-based evidence that supports going with the hazard-based over other outcomes? I’m asking the question, I don’t know the answer.
Mr. Annau: I’m not sure of any actual specific studies that have been done to compare the two. Unfortunately none come to the top of my mind right now.
I think one of the approaches we would be advocating for would be for any standards to be informed as much by field-based evidence as possible, any kind of studies done in our case specific to the application of pesticides on crops, any studies that would show whether this application was having adverse impacts on any of the surrounding water invertebrates to see whether populations, after application, are maintained or do they diminish.
In certain instances where the population does remain the same despite the application of pesticide being above a certain maximum residue limit that is proposed, that would indicate the actual residue limit itself may be too conservative. The main issue with farmers right now is that during PMRA’s scientific assessment phase, any data showing reduced risk is not allowed to be submitted, but scientific assessment data showing increased risk is. The main concern is that this may create a bias in analysis that may trigger more cancellation decisions.
The Chair: Okay. Thank you folks. That has been great. I’d like to thank the panellists, some of whom have been here in the past. It is always good to have them back.
We have a new panel consisting of one person, Kathleen Cooper, Senior Researcher with the Canadian Environmental Law Association. Thank you for accepting our invitation to be here this evening. Please make your presentation and then people will have questions for you. The floor is yours.
Kathleen Cooper, Senior Researcher, Canadian Environmental Law Association: Thank you very much for the opportunity. I would like to raise some concerns with the amendments in Bill C-97, recognizing that they are intended to improve efficiencies under the Pest Control Products Act, but as drafted, the changes could limit public participation and reduce transparency.
The problem is easily fixed with amendments to ensure that existing legislative guarantees of consultation and accountability are maintained, preventing further eroding of public confidence in the federal pesticide regulation. That summarizes what I have to say. I will provide some background and context to start.
Pesticides are toxic substances intended to kill living organisms, whether it’s weeds, insects, rodents, what have you. As such, they need to be carefully regulated, and there must be a public trust in the regulator. For many reasons, that public trust is not always present, and it is in nobody’s interest for there to be a lack of public trust in the regulator, not the public, not pesticide manufacturers, farmers, beekeepers, pest control companies, the government or anyone. It wastes time. It wastes money. It causes a lot of stress and anxiety, and when it leads to poor regulatory decisions, it creates environmental and human health risks and harm.
People are aware of different regulatory decisions about pesticides elsewhere, particularly in Europe. You were just speaking to some of them. Some EU countries have banned pesticides that we still allow. The International Agency for Research on Cancer concludes that glyphosate is a probable human carcinogen. The key underlying difference here has to do with basing decisions on hazard assessment versus risk assessment. In the risk assessment framework, information is combined about hazards and exposure.
The EU approach might be seen as stronger and our approach more lenient, while risk assessment proponents will see it as a more realistic approach that accounts for actual exposure. It arose in the early 1980s, and it is considered science-based. It is science-based. It has many complex scientific inputs and calculations. The Pest Control Products Act requires it, and the public is implicitly asked to trust the outcome.
But scientific information about environmental and human health risk is always complex and incomplete. Many mistakes have been made. In the 1980s and 1990s, many countries restricted and banned the organochlorine pesticides, including Canada, such as DDT, aldrin, toxaphene, chlordane, a range of them, very nasty chemicals that cause cancer, reproductive toxicity and many other health effects and are highly persistent in the environment.
The organochlorines were largely replaced by the organophosphates and carbamates, also very toxic, most often on the developing brain as well as having other health and environmental effects, and we’ve had to progressively get rid of most of them too. They were widely replaced with the neonicotinoid pesticides, now implicated in the worldwide decline in pollinator species. They are also being phased out.
As the glyphosate trials are working their way through the U.S. courts, juries are hearing about Monsanto’s manipulation of the scientific record with ghostwritten studies, collusion with regulators and other shady tactics. Juries are agreeing that glyphosate caused cancer in the plaintiffs and are awarding multimillion-dollar settlements.
Very recently, scientists have reported on a worldwide decline in insects, with extinction of 40 per cent of the world’s insect species possible over the next few decades and for which pesticides are partially responsible, alongside habitat loss from intensive agriculture, urban development as well as climate change.
Against that backdrop, it doesn’t require much more than healthy skepticism for trust in the pesticide regulator to be shaken.
Turning to special reviews and re-evaluation, as we noted in our letter to your committee and in our letter to the Commons Finance Committee reviewing Bill C-97, the main purpose of the PCPA is to prevent unacceptable harm and environmental and human health risks from pesticide use. It arose from a multi-year effort to modernize pesticide regulation in this country and ensure public confidence.
It requires pre-market assessment of pesticides and their periodic re-evaluation on a 15-year cycle, as you’ve discussed. It also allows for special reviews between re-evaluations if new scientific information comes to light or a pesticide is banned in another OECD country.
A recent example is naled, an organophosphate pesticide that was banned in the EU. Section 17(2) prompted that automatic special review. The PMRA also did another special review under section 17(1) to address other evidence of concern, which is another tool that they have. Those two reviews conclude that the risks are unacceptable and they propose the cancellation of all uses. Those two special reviews advanced regulatory action on a dangerous pesticide probably by about five years, and I think that’s a good thing.
Special reviews are an essential part of a responsive pesticide regulatory system. They help ensure we don’t overlook emerging science and concerns. Public input to the special review process, like all other pesticide PCPA decisions, is part of that responsive and trustworthy regulatory system. The requirements for public input are set out in section 28 of the act.
With Bill C-97 amendments, our concerns are that they could limit public participation and reduce transparency while extending broad discretion to the health minister to decide not to initiate special reviews.
We want to ensure that, for example, the new section 17(7) — that’s the section that allows ministerial discretion not to initiate a special review — be redrafted to specify that any decision made pursuant to it must be made before publication of the public consultation statement that’s required under section 28. Basically what that means is it would maintain what are existing legislative guarantees for public consultation on the matter that would have prompted the special review. We’re simply asking for these amendments to incorporate the existing legislative requirements for public consultation that are in section 28.
Our second recommendation relates to special reviews under section 17(2), which is the one if an OECD country puts in place a full ban. Bill C-97 introduces an exception, giving the minister discretion to determine whether it’s warranted but with no criteria for doing so and no notice or consultation requirement. We’re recommending that that decision by the minister be made public, along with the minister’s reasons for the decision, again, extending the existing legislative requirements that already exist, making sure that’s covered off.
To close, I want to underscore my comments with positions advanced this year with respect to the budget by the Green Budget Coalition, calling for increased funding to the Pest Management Regulatory Agency to deliver on its legislative mandate and obligations. A lot of progress has occurred to address the backlog in re-evaluating older pesticides and on the cyclical re-evaluations, but funding to the PMRA has stagnated in the face of significantly more workload. You have heard about how it will continue. There are key compliance challenges and a long-standing lack of essential data necessary for pesticide exposure assessments.
I won’t get into the need for more resources for meeting their legislative obligations on proposed market assessments or for compliance challenges. We can talk about that if you want, but I want to emphasize a final point about exposure assessment and circle back to my initial comments.
As I mentioned, the key difference between hazard assessment and risk assessment is including information about pesticide exposure. Yet in risk assessment for pesticides or anything else, exposure assessment is always the weakest link. We don’t have a national water monitoring program in Canada at all, much less a program that meets the more specific needs of exposure assessment during pesticide regulation, nor do we have adequate data collection about pesticide use, despite significant changes in farming practices as farmers modernize and move into new markets. Exposure assessment cannot be reliable without good data collection in both of those areas — pesticide use and environmental levels — particularly in ground and surface water.
Again, for there to be a public trust in the regulator and the regulatory approach of risk assessment, which is what our law requires, there must be adequate funding. Permanent investment is needed — permanent, not the vagaries of funding from one year or government to the next. Permanent funding is that essential data collection in Environment and Climate Change Canada on water monitoring, and Agriculture and Agri-Food Canada to support that pesticide exposure assessment work that has to happen within the PMRA. The PMRA also needs more resources to analyze those data, as well as meet their post-market regulatory obligations.
I’ll conclude by saying that we accept that the Bill C-97 changes seek to accomplish streamlining during special reviews, but they shouldn’t and need not undercut the environmental and public health purposes of the act or interfere with sound decision-making.
With some discrete amendments, the existing legislative guarantees of consultation and accountability can be maintained within these new amendments, preventing any further erosion of public confidence in federal pesticide regulation. Likewise, and closely related, we will continue to advocate for more resources for the PMRA to be able to meet its legislative obligations under the PCPA and to increase public trust in Canada’s pesticide regulator. Thank you.
The Chair: Thank you for your presentation. We have senators lined up to ask questions, and we’ll start with Senator Kutcher.
Senator Kutcher: Thank you very much. I enjoyed your presentation.
Thanks again for raising the issue of the difference between hazard assessment and risk assessment. My colleague, Senator Moodie, asked that question previously, and I want to ask you the same question in a slightly different way.
Can you share with us outcomes that have compared hazard assessment against risk assessment models, either using comparative analysis or non-inferiority analysis, showing there are meaningful differences in outcomes about decisions whether or not to use a pesticide, depending on how the assessment was made?
Ms. Cooper: I would like to be able to think carefully about that question and get back to you. I’m sure analysis has been done on it. There is an excellent report by the European Environment Agency that made those kinds of comparisons in a number of areas. It’s called Late lessons from early warnings, so applying precaution in the face of uncertainty. Those sorts of comparisons are made. Maybe it’s because it has been a long day, but I can’t come up with a specific example.
It’s just a different approach. You heard earlier that there is a whole bunch of anticipated bans in the European Union for pesticides that are coming up in the next few years, or anticipated. That has to do, I understand, with a hazard-based choice of saying: Above a certain level of pesticide in groundwater, if a pesticide goes beyond a certain level, that’s it; you can’t use it.
We don’t use that kind of approach here. We’ll look at the hazard information and then we’ll say: Look at what the exposure calculation is. You put the two together and see whether or not you are going to have a risk.
In the European approach, which leads to a lot of those bans that have happened, it is like: If it meets that level in groundwater, that’s it; we don’t want it anymore, so go to something else.
You get a different outcome between the two systems. I’m sorry; I’m going off on a tangent.
Senator Kutcher: I hear what you are saying, and I appreciate that. I understand you can get to a different outcome. I’m asking whether or not the outcome is meaningful, can we document a difference in outcomes on human health or on health of livestock or whatever?
Ms. Cooper: You could very well. It’s a complex measurement and comparison to make. It’s possible, with the studies that have been done in terms of loss of pollinators, that you might see differences if you make those kinds of comparison in terms of, say, use of !neonics in some areas and not others, and whether or not you are seeing quantitative differences in populations of pollinators. That may be the case.
I can’t answer it off the top of my head, but I want to dig in and see what evidence is in the literature making that comparison.
Senator Kutcher: That would be wonderful if you could.
Ms. Cooper: The fact remains that we have risk assessment-based approach in the law that we have now. Whether or not there are functional differences, the law is the law here now; it has to be applied in the risk assessment approach that we have to apply.
Senator Bernard: I have one question that I want to ask. You’ve referenced the need for public trust, public participation and public consultation. We’ve heard from other witnesses that they were not adequately consulted about the proposed regulatory changes.
Do you think the government adequately consulted its departments in the agriculture and agri-food industry before proposing those regulatory changes to the Pest Control Products Act?
Ms. Cooper: My understanding is these amendments came from consultation that was held last summer. I believe I heard in the previous panel that there was consultation with the stakeholders previously represented.
On the environmental and public interest side, we were not aware of these changes until about two months ago. That’s why we responded quickly and did some analysis of the implications. I’d say the sectors you mentioned certainly had more consultation opportunities than I did, or my organization did.
Senator Bernard: Can you expand for us your thoughts on the link between public consultation and public trust, for the record?
Ms. Cooper: In terms of public consultation, there are already baked into the statute opportunities for reviewing requirements by the minister to publicize and propose decisions, whether it’s a re-evaluation, a special review or a new pesticide registration, and the public has the opportunity to review and respond. We can go to the reading room. It’s not a perfect system, but there is a range of public consultation opportunities throughout the statute, and rightly so.
The issues of public trust are part of that, but they also have to do with what people hear about in terms of the glyphosate trials in the U.S., the decline of insect species, concerns they have about the use of pesticides. There is a range. That’s why I spelled out the history of all of this. I have been doing this work long enough to remember all those times, all those classes of chemicals having to be phased out and banned.
It’s understandable that people are concerned when they see that kind of situation happening repeatedly. Not everyone can engage at the level, say, that I or my organization can, but they want to know and to trust that the government regulator is responsibly looking out for the public interest. When I hear a suggestion of overlaying a competitiveness lens on the work of the Pest Management Regulatory Agency, which is an agency of Health Canada that has a mandate to address health and environmental risks, there is no room for a competitiveness lens. It’s not appropriate. That takes us back 40 years. I’m old enough to remember that. The pesticide registration review program that happened in the late 1980s and early 1990s was in response to a lack of recognition of health and environmental risks of pesticides. One of the most fundamental changes that happened as a result of that, and then all of the changes that happened through the 1990s and up to the modernization of the Pest Control Products Act and the law we have now, was to move pesticide regulation out of the Agriculture Department and into the Health Department where it belongs.
Senator C. Deacon: I appreciate your comments around transparency, because transparency is a good thing and if you’re making a good decision you shouldn’t be concerned that it’s quite public. I appreciate that you’ve made those, and I look forward to discussing those in our comments to the extent that others would agree.
The discretion of the minister — and when I read the elements that are there, I felt they were quite comprehensive. When the minister chooses not to conduct a review, there has to be some pretty good reason put forward.
Ms. Cooper: She should publicize them. That’s all we’re asking for.
Senator C. Deacon: I want to confirm, you’re comfortable with the criteria, you really want to make sure that it’s out in public?
Ms. Cooper: And codified in the law as other requirements for consultation are. They’ve left it out. I literally think it got left out in putting these amendments together. It can be put in easily. It makes sense to streamline this. Frankly, when we’ve had a number of special reviews over the last few years as a result of those OECD bans, it becomes a bit of a pro forma exercise in the PMRA because we don’t have the same approach. They look at the ban that was done on the basis of, say, that ground water limit or whatever. Whatever reason the OECD country, say Norway, put in place a ban, the PMRA looks at it and says, “Okay well, that’s the hazard we’re going to look at exposure. We don’t agree.”
There hasn’t been a single one of those OECD bans that have resulted in a similar regulatory action in Canada. What this does now, is it gives the minister the discretion to look at it, look at what they did and say we disagree. What we’re asking for is to make sure that the minister is required to state the reasons and publicize it, which is what section 28 does for other parts of —
Senator C. Deacon: Thank you. I wanted to make sure I was really clear that you were comfortable with the criteria.
Ms. Cooper: Codify it.
Senator C. Deacon: Thank you.
Senator Doyle: I would imagine we would keep a pretty close eye on what happens in the United States with respect to their regulatory environment. How do we compare here in Canada with the U.S. with respect to, say, the number and the kinds of pesticides that we are banning and what they are banning? Is our regulatory environment better, stronger and stricter than what they have in the United States? Is our pesticide use lower than what they have and what they use down there?
Ms. Cooper: Any comparison to the United States right now is a little awkward to make. Any comparison to the United States right now, I kind of don’t really want to make, but yes, I think we’re roughly comparable. I think if you look back over, say, since the mid-1990s, a lot of change happened in the United States, faster than here. Changes in the pesticide law happened in response to emerging evidence about the effects of pesticide on children and on the developing fetus. A lot of reforms happened. That’s why we’re going through this huge backlog of re-evaluation and we’re almost finished it, because all these pesticides hadn’t been assessed according to modernized approaches. A lot of those had to do with addressing the special vulnerability of children, for example.
The U.S. was a lot further ahead of us on that in terms of changing the law and implementing it. We caught up with the current Pest Control Products Act and the changes that were put into it. I would say we lag behind the U.S. 5 to 10 years, roughly, in processing it all through. It’s not that different than Canada, although I think we have a regulatory system that we can be proud of.
There’s an expression that I hear all the time. I’m on the Pest Management Advisory Council, and there’s a description of the PMRA in the international sphere of punching above its weight. The PMRA is very well respected and is involved in a lot of these international arrangements, from data sharing and what have you, not just working with the U.S. but with other countries as well.
Senator Doyle: Thank you.
Senator Moodie: I have a two-part question.
The first part is lessons learned around organochlorines persistent in the environment, which you commented on. How long has that been now? Do we still test for it and do we still know it’s there?
Ms. Cooper: That’s a really good question. The organochlorines were phased out and ultimately banned in the early 1990s to mid-1990s, and then were incorporated into the Stockholm Convention on Persistent Organic Pollutants. They’re not used in Canada anymore.
Senator Moodie: Are they still around?
Ms. Cooper: Absolutely, they’re still around.
Senator Moodie: What is the life cycle of things that eventually hit our water table in levels that concern us?
Ms. Cooper: There are frightening levels of mirex, for example, in the basin of Lake Ontario.
Senator Moodie: They continue to be?
Ms. Cooper: They are circulating in the environment. That’s why they are banned, because they are so persistent.
The key point that you raise that is an important PCPA reform issue — and it could be done within the existing law or perhaps the regulation — is that there are a lot in the law about addressing human health and the context comes from the reforms that happened in the 1990s and what we were responding to. What we don’t necessarily have is good work or requirements for environmental persistence, for example.
I’m also on the Ontario Pesticides Advisory Committee. We classify pesticides for use in Ontario after they’ve been approved federally, and we quite recently, four months ago, we saw a pesticide come forward for classification in Ontario that has a soil half-life of four years. I couldn’t believe it, and neither could a number of other people on the committee. Why are we approving pesticides that have a half-life of four years? That doesn’t seem right to me at all.
It’s a lack of rigour in the act on the environmental side. We’re pretty good on the human health side, but we need more rigour on the environmental side.
Senator Moodie: The second part of the question has to do with some of your comments: no national water monitoring program, no adequate data around usage and/or water levels and no good data collection.
Ms. Cooper: Not enough. Nowhere near enough.
Senator Moodie: And the OECD is currently an alert, an external trigger that helps us transform, on occasion, from a risk-based to a hazard-based. It forces us based on the current existing —
Ms. Cooper: It forces us to look again.
Senator Moodie: The other comment you made was no OECD alerts have resulted in any change in decision here.
Ms. Cooper: Not that I’m aware of. Maybe. Naled was banned and it forced us to look at it. There were two special reviews on that one because of the automatic requirement for this under section 17.2, and then under 17.1 the PMRA did another one because of additional evidence. On the basis of both of those, they’ve recommended that this pesticide be banned.
Senator Moodie: What is the lens that the PMRA is using that applies science to their decision, and is that published openly?
Ms. Cooper: Absolutely. It’s risk assessment. It’s a combination. You multiply the hazard times the exposure. You put those two together. There are all kinds of complicated science behind both of those.
Senator Moodie: Without any understanding of water level, without any understanding of —
Ms. Cooper: They do modelling, and it’s not good enough.
Senator Moodie: We have an imperfect system and we draw conclusions from that, but we want to get rid of our backup alert or trigger.
Ms. Cooper: Yes. And that’s why we have re-evaluation and special reviews. That’s why we don’t describe pesticides as safe. They are of acceptable risk. It’s a very important difference, acceptable according to the information available at the time.
Senator Moodie: And emerging science has not explained to us what our risk really is for some of these exposures we are currently having. That will come down the line after the fact.
Ms. Cooper: We’re especially not going to know about them if we’re not measuring exposure. That’s half the risk assessment calculation. If they want trust in risk assessment, then do proper data collection for exposure. But that means more money.
The Chair: Thank you, senators, for your questions. I’d like to thank our panellist for her presentation.
And on behalf of the committee, I sincerely thank our next panellist for appearing with us today. From Health Canada, we have Mr. Jason Flint, Director General, Policy, Communications and Regulatory Affairs Directorate, Pest Management Regulatory Agency.
We’ll ask Mr. Flint to now make his presentation.
Jason Flint, Director General, Policy, Communications and Regulatory Affairs Directorate, Pest Management Regulatory Agency, Health Canada: Thank you, Madam Chair. I’ll keep my opening remarks fairly short. I was invited here today to speak about the changes to the Pest Control Products Act that are being proposed in Bill C-97. These changes are part of a commitment the government made in the Fall Economic Statement to introduce an annual modernization bill to remove outdated or redundant regulatory requirements and to allow the updating of legislation.
This annual exercise is intended to help keep legislation current to better reflect public policy and business realities, challenges and opportunities.
These changes to the Pest Control Products Act were identified during consultations held last summer as part of the targeted reviews of regulatory requirements and practices coordinated by the Treasury Board of Canada Secretariat. The reviews were designed to identify and address bottlenecks to economic growth and innovation as part of a larger regulatory reform agenda focusing on supporting innovation and business investment.
The Agri-Food and Aquaculture Sector Regulatory Review Roadmap, which will be published in the near future, includes the proposed amendments to section 17 of the Pest Control Products Act that we are discussing here today.
As background for the committee, pesticides are regulated by Health Canada with the primary objective of protecting health and the environment. All new products undergo a scientific risk assessment before they can be authorized for use in Canada. Once registered, products are subject to re-evaluations to verify that they continue to meet modern standards for health and environmental protection. These pesticides are also subject to special reviews where information becomes known about an aspect of the product that raises a health or an environmental concern.
The issue that these amendments were designed to address was associated with subsection 17(2) of the Pest Control Products Act, which requires Health Canada to initiative a special review of a pesticide whenever a member country of the Organisation for Economic Cooperation and Development, the OECD, prohibits all uses of an active ingredient for health or environmental reasons. The way that this provision is written can result in multiple reviews of the same aspect of concern, on the same pesticide, having to be conducted at the same time or in quick succession, and with no added benefits to Canadians in terms of health or environmental protection.
The proposed amendments would allow Health Canada to expand the scope of an existing post-market review rather than initiating a new special review, or decide not to initiate a special review if the issue of concern is being, or has been, addressed in another post-market review.
With these amendments we will continue to conduct new special reviews where it is in the best interest of Canadians’ health and the environmental protection to do so.
Further amendments were discussed yesterday by the House of Commons Finance Committee in response to concerns that the proposed amendments could be interpreted as limiting transparency of certain decisions with respect to special reviews. The new amendments are designed to ensure that the minister would always consult on a new aspect of concern that was added to an ongoing post-market review and decisions not to conduct special reviews under 17(2) would be made public.
The proposed amendments that you see before you today would reduce duplicative work, provide savings for both government and industry without compromising Canadians’ health or environmental protection.
Thank you for taking the time to listen to me today. I’d be pleased to answer any questions you may have.
The Chair: Thank you, Mr. Flint.
Senator C. Deacon: You’ve answered, in your last comments, a key question for me, which is how you responded to some of the suggestions made.
But I want to broaden that out and say that you’ve been here through our last two panels. Is there anything that you’ve heard that you’re uncomfortable with, you disagree with, you feel like we haven’t heard the whole story on that you would feel we should hear another perspective on? That’s pretty broad, but it also is a catch all for us to do a bit of an audit on what we’re heard.
Mr. Flint: It is. The special review revisions under the current Pest Control Products Act, we’re focusing on the one right now which is the requirement to do a special review based on an OECD decision.
There are other provisions under section 17 of the act, and 17(1) states very clearly that if the minister has reasonable grounds to believe that the health or environmental risks are no longer acceptable, she must conduct a special review. There are provisions under 17(3), if the provinces provide information to us that gives us reasonable grounds to believe the risks are no longer acceptable, we must do a special review.
Under 17(4), any member of the public may request a special review. If we feel there are reasonable grounds to believe that the risks are unacceptable, we will conduct a special review. It’s that test of whether there are reasonable grounds to believe that the risks are no longer acceptable that usually drives the requirement to do a special review.
But 17(2) doesn’t have that test. We’ve looked to see how we can reduce having to redo the same analysis on the same information when we are concerned about decisions, perhaps out of Europe, as what we’ve heard about here. If an European Union decision is made on an active ingredient, our concern is that as each and every member country then removes all uses of that product, we would need to do a special review based on the U.K. decision, based on the German decision, based on the French decision, et cetera, which is not a good use of anybody’s time.
We believe that we should do it once and then, if there’s no new information to consider, we should not do another special review.
To date, since 2013 we’ve done 48 special reviews, 34 of them based on OECD decisions, and 14 based on 17(1) of the act, meaning the minister has reasonable grounds. Of those, several of them are duplicative. For example, we’re consulting right now a decision on Naled, which is an organophosphate pesticide, and there are two special reviews: one based on an OECD decision and one based on our concerns that we had on the same product.
This particular amendment, if it was made previously, would have allowed us to roll the OECD decision into our assessment based on the information we already had, and we wouldn’t have to do two and be consulting on two separate decisions for the same product for pretty much the same aspect of concern.
Senator C. Deacon: So you’re very comfortable with where this is heading. One area where you didn’t identify there was a problem was the two to four years to complete a review. Let’s look at the 48 special reviews that you talked about. We now could eliminate those, potentially.
Mr. Flint: Some of them, yes, but not all of them.
Senator C. Deacon: How much capacity is going to be freed up to start to shorten timelines on reviews? Does it take two to four years to complete a review or is it simply backlogged? Where are we with that? This is an environmental and health and safety issue and it’s a competitiveness issue.
Mr. Flint: There will be some resource savings. It will not be enough to fully address the backlog in re-evaluations but it will particularly prevent some of the new special review concerns that we have coming forward.
Senator C. Deacon: You still have a big workload coming at you?
Mr. Flint: There is a significant workload coming at us, as one of the other speakers mentioned. Over the next five years we’re going to see a significant increase and even more so in the five years after that.
The timeline is based on our new approach. As the previous speaker mentioned when this new legislation came in it gave us an obligation to redo these re-evaluations. We started in 2000 with the first round of re-evaluations. Pesticides have been registered in Canada since 1927. That’s when the first legislation came in. In 2000, we started down the road of saying we’re going to need to re-evaluate everything, then in 2002 when the legislation came in, it created a requirement for us to do these so that pesticides should not go more than 15 years without us initiating a re-evaluation to see whether it continues to meet modern standards.
During that first round of re-evaluation, I think we were averaging about eight years to try and do a review. In the cyclical approach we’re now getting re-evaluations down to two to four years, but in order to do that there are some costs. Some of that is reflected in less opportunity for consultation, for example, with some of the stakeholders. Providing more consultation requires more time and that also extends the time it would take to do these reviews.
There’s always a balance as a regulator. You’re balancing the time it takes to do the work with how much engagement and how much new information is being introduced into the process.
Senator C. Deacon: It takes two to four years to do a review. How much of it is due to a backlog? Let’s say we’ll cut it in half so there is a three-year review happening. How much of that time is backlogged and it’s getting into the system and waiting for its number to come up? And once that happens, how much of it is reviewing the science or completing a scientific review and consultation? How does that generally play out? Just give us a day in the three years of a review.
Mr. Flint: I guess the process plays out where, initially, we will do some work even in advance of that starting. We’ll start to scope out and see what information we have.
When a new pesticide is registered or a new active ingredient is registered, a typical submission comes to us with about 30,000 pages of scientific studies. It covers everything from basic toxicology, exposure scenarios, environmental fate, environmental toxicology, efficacy of the product so that it works and the chemistry of the product. You have this very large scientific package that comes in.
When it comes around to re-evaluation, you then have to find out what else is out there. What submissions may have come in the last 15 years from the original registrant? What’s available in the public literature and the scientific literature? What decisions may have been made by foreign jurisdictions that may be of interest to us?
There’s a scoping period that happens even before we start to initiate to see how much work is out there and what’s going to be involved with this. Then we initiate. We have to contact the registrant and the manufacturers of the pesticides, and we also post that we’re doing this. We contact the provinces to ask if they have any particular data that we need to be considering, such as monitoring data. We also look at our own. We have an instant reporting requirement, so if companies are aware of any incidents involving their products, they are required to report those to us. We analyze that data.
There’s a period of time at the beginning where we also ask for what additional data a registrant has that we might not have but that we might want access to. We have requirements to provide to us any data that would show that the risks are increasing. They already provide that immediately, but we can also ask if there’s other data they may have submitted to other jurisdictions that might be of interest to us. We can add that.
Then we start the risk assessment. We go through that risk assessment process and that can take a year or two, depending on how complex it is.
We then generally do a consultation on the risk assessment and our proposed changes. That’s usually 60 days but it can be 90 days depending on what the requirements are. Then we look at those comments that we receive. We may receive additional information during that consultation period. Someone may provide studies to us to suggest for us to consider. If there’s information that’s provided that requires us to take another look at our risk assessment and incorporate that, we will.
Then we put out a final decision following that and a summary of whatever comments and information we received during the consultation that accompanies our final decision.
It’s a fairly involved process. That four years is more of an ideal than an actual. If you get a lot of significant information provided during a consultation, it can extend that process to reconsider it.
Senator C. Deacon: Thank you very much, Mr. Flint. I really appreciate that. Thanks for the work that you do.
Senator R. Black: The previous speaker talked about the need to have additional transparency. You spoke in your closing remarks about further amendments discussed yesterday in response to concerns talking about adding the additional transparency and making things public. Is that correct? Am I clear in reading that you’re open to essentially what was asked for earlier?
Mr. Flint: That is correct. I guess the motions were considered as part of the clause-by-clause during the House of Commons Finance Committee meeting yesterday. Two motions were proposed and adopted. One motion was just that, looking at when we do a consultation. If we’re consulting on a decision, we can’t add a new aspect of concern after that consultation period unless we are prepared to reconsult.
That was one of the provisions that was added.
The other provision was to make public decisions to either not conduct a special review or, if we’re going to be rolling something into an existing review, we would make public the decision that we’re doing that and the reason why we’re doing it.
Both of the previous speakers’ concerns should be addressed through those two motions that were adopted yesterday.
Senator R. Black: Thanks very much. I have no other questions.
The Chair: Thank you.
Senator Kutcher: Thanks very much. That was a clear and short brief.
In your opinion, would the new approach in any way weaken the quality of the reviews that are conducted or in any substantial way increase the risk to health of Canadians or in any substantive way increase the risk to the environment in Canada?
Mr. Flint: No, it would not in any way affect the quality of the reviews we are doing or increase the risks.
All we’re talking about doing here is preventing having to do the same review on the same information. As it is, we have not included in the proposed amendments that test of reasonable grounds to believe there is a risk. The first time a foreign jurisdiction makes a decision on a set of information that says we are getting rid of a product for health or environmental reasons, we are still required to do a review under this. We are not required to do it a second time if another country makes the same decision based on exactly the same information. There should be no impact either on the quality of our decisions or increased risks to Canadians.
The Chair: Thank you.
Senator Moodie: My question has to do a little more with the quality of the assessment. I’m hearing that the trigger is there, that you will go to a review if the first OECD country raises an alarm. That’s good. That means “hazard versus risk” is still in place. I like that.
My concern is this. It sounds to me — correct me if I’m wrong — that we have a system of voluntary reporting. If companies that produce these pesticides are aware of issues, they need to report. Is there anything that compels them to report?
Mr. Flint: Yes. There is a voluntary reporting system for the general public if they wish to provide us information about an incident. If a company is aware of an incident involving their product — often there will be 1-800 numbers on the product labels — they are required to report it to us as part of section 13 of the Pest Control Products Act.
There is a set of regulations around incident reporting. It is not voluntary for the companies. If they are aware of it, it is mandatory that they report it. In fact, we have expanded it such that, because we are so close to the U.S. and there are a lot of products used on both sides of the border, they are required to report to us any incidents that occur in the U.S. as well. We have a mandatory requirement that covers that, so a significant number of incidents we receive is from the much larger U.S. market to the south of us. We can look at those instances as well to consider as part of our trend analysis.
Senator Moodie: I want to continue on that topic of the quality of the assessment. Without the data — we were hearing the impression it is not collected — and without the understanding of local water levels and water monitoring, what additional information do you apply, besides international learning from other jurisdictions, absent of local knowledge? What lens do you apply that allows you to now review and draw a conclusion that something is safe? What have you done on a local basis to reassure yourself that the environment doesn’t have a residue of this product, that the water level has not been breached to a dangerous level? Can you give me a sense of what new additional information you have at the time a review is triggered by an OECD company concern? What would you do?
Mr. Flint: I would start by reiterating that we do have a pre-market system in place. We do receive a significant amount of information about these products before we approve them for use originally. We do water modelling. Based on the physical and chemical properties, we have a fairly good sense of what should or could appear in the environment based on the product being used. There is a certain conservatism built into our risk assessment. We will overestimate, rather than underestimate, what will be going into the environment when we use those numbers to feed into our risk assessment.
When the product is approved, we will consider any information that is available. It is true there is not a national water-monitoring program. There is no consistent way that water monitoring is done across the country. Some individual provinces do a fairly good job of water monitoring. We do consider that. For example, during our recent review of the neonicotinoid insecticides, we did have, from some provinces, fairly good water monitoring. It did not give us a picture of what is going on across the country but, in those particular provinces, we did have that information and it was factored into our risk assessment. It gave us a sense of comparison to the modelling we did originally. It did identify some situations to explore and to ask if there is a situation of non-compliance there. Is the product being used carefully? It allowed us to explore better.
Senator Moodie: How long does it take? I know it will vary from chemical to chemical, but can you give us a sense of the timeline that it takes to get to a level of contamination that would be of concern? Is it eight years, fifteen years, two years? A new product comes into the market, and it has unexpected consequences. How long do you think it takes for the groundwater level table to be breached? I don’t know that. Can you give me a sense of that timing?
Mr. Flint: The risk assessments we do are designed to be protective of the environment in the long term. It is not that we are approving a product that will only be safe for use for the next five or seven or eight years. The intention is we are approving a product that will be acceptable in the long term for continued use. We don’t look at a product that way, to say it will be good for X number of years but not allowed for the long term.
Products will have different half-lives, as the previous speaker said. Considering that, you then have to consider how much will be going into the environment. How frequently can it be applied? We put directions on product labels. It may say the product can only be applied every second, fourth or fifth year. We can have different criteria that a product can only be applied in a certain way. Our directions for use are very specific. It may say the product can only be applied to certain things; it can only be applied at this rate; it can only be applied this many times. You cannot apply it so many days prior to the harvest. You will be required to wear the following protective equipment. You will be required to have buffer zones to protect the environment outside of the field, if it is an agricultural product.
There are a number of protections to be put in place, but it is not ever intended to have levels in the environment reach levels that become problematic.
The Chair: Those are our questions. Thank you. I would like to thank our three panels. It has been a great evening. Everybody has been concise and I appreciate that.
We will briefly continue in camera. Are honourable senators agreed?
Senator Doyle: Of course we are.
Some Hon. Senators: Agreed.
The Chair: We could do it by email. We will keep it short.
(The committee continued in camera.)