[Recorded by Electronic Apparatus]
Tuesday, June 18, 1996
.0846 
[Translation]
The Chairman: Good morning, ladies and gentlemen. Pursuant to Standing Order 108(2), we are going to consider the topic of biotechnology.
[English]
The focus of today's meeting is agriculture and its regulations. Last week when we met with almost the same team of witnesses the focus was on the health regulations. These two meetings are very important for us, and specifically for the researchers in order to penetrate into the mysteries of biotechnology bureaucracies, if you like - in the most positive sense of the word, of course.
So without any further delay and with my apology for being late - we came from a meeting that started at 8 a.m. in another building - we will ask who wants to be the first. Who is in charge of the team? Dr. Morrissey, would you like to introduce your colleagues, and we'll go through the usual routine: short presentations and long questions.
Dr. J.B. Morrissey (Assistant Deputy Minister, Research Branch, Department of Agriculture and Agri-Food): Thank you very much, Mr. Chairman. My name is Brian Morrissey, from the Department of Agriculture and Agri-Food.
With me is Margaret Kenney, whom I think the committee has met before, also from the same department; Paul Mayers from the Department of Health; and Dr. Desmond Mahon, whom the committee has met before, from Environment Canada.
[Translation]
Mr. Chairman, members of the committee,
[English]
since its inception, the Department of Agriculture and Agri-Food has been involved in regulating the introduction of new organisms into Canada. For example, as early as 1910 the Canadian Destructive Insect and Pest Act was promulgated to enable the department to conduct pre-import and pre-market assessments of new plants coming into Canada to prevent the entry of pest organisms into this country.
While the department has always been in the business of conducting these types of assessments, the scope of assessments has widened in recent years to accommodate the new products of biotechnology.
Agriculture and Agri-Food Canada is responsible for administering five acts under which biotechnology products are regulated. These are the Seeds Act, the Feeds Act; the Fertilizers Act; the Health of Animals Act; and the Plant Protection Act. In 1994 Justice Canada confirmed that all have the authority to regulate biotechnology products with respect to environmental safety, including the safety of humans in the environment.
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In 1995, Justice also approved of the addition of the Canadian Environmental Protection Act definition of biotechnology, the application of science and engineering to the direct or indirect use of living organisms, or parts or products of living organisms, in their natural or modified forms. This definition includes both living products - for instance, microbes and plants - and non-living products such as some types of vaccines. The technologies used to derive these are both modern, such as genetic engineering, and traditional - for example, the selection of youthful individuals with desirable characteristics from a population.
Secondary regulatory amendments relating to notification and environmental assessments have been drafted under the Seeds Act, Feeds Act, Fertilizers Act, and Health of Animals Act. These proposed amendments include the use of CEPA's definition of toxic. These will serve to clarify that safety assessments will ascertain whether an organism or product is toxic if it's entering the environment in a quantity or concentration that has or may have an immediate or long-term harmful effect on the environment, constitutes or may constitute a danger to the environment on which human life depends, constitutes or may constitute a danger in Canada to human life or health.
In January 1995, Environment Canada provided Agriculture and Agri-Food Canada with written confirmation that these draft regulations and guidelines provided for an assessment of potential CEPA toxicity. Complementing these regulations, Agriculture and Agri-Food Canada has developed guidelines for each of the commodity areas. These have benefited from national and international consultation. They provide interpretation of the regulations and assist in their application by laying out specific information and procedure requirements.
Agriculture and Agri-Food Canada and Environment Canada have agreed to carry out consultations on the right mix of regulations and guidelines when these amendments are published in the Canada Gazette, part I.
Within the regulatory branch of Agriculture and Agri-Food Canada, there is a variety of expertise to carry out the application of these regulations and guidelines. These include animal nutritionists, animal and plant pathologists, ecologists, entomologists, human and environmental toxicologists, molecular biologists, microbiologists, plant breeders, soil scientists, veterinarians, virologists and wheat scientists. This combination of expertise is important for a complete evaluation of the safety of agricultural products of biotechnology.
The focus of the relevant acts is as follows. The Seeds Act and regulations provide Agriculture and Agri-Food Canada with powers to refuse or cancel registration of a plant or its offspring that may be damaging to human or animal health and safety of the environment. These authorities cover both: firstly, field testing under conditions that serve to confine the plant in terms of its ability to spread seed and pollen; secondly, larger commercial plantings.
Assessments of plants with new traits are conducted regardless of the breeding method or process used to develop the new plants. Approvals for field testing and commercialization occur only after thorough environmental assessments that include considerations about the plant's potential weediness to agriculture or natural habitats, ability to pass genetic information to related species that may become weedy, potential to become a pest, potential to cause unwanted interactions with other organisms in the environment, and potential to cause negative impact on biodiversity.
The method used to develop these plants is explained in relation to the effect on safety of the final product, that is, where the genes came from and how they were introduced. Examples of some of the new plants from biotechnology that have been assessed and approved include Colorado potato beetle-resistant potato, European corn borer-resistant corn, canola with modified oil composition, herbicide-tolerant canola, and corn, soybean and flax tolerant to herbicide soil residues.
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Approval for food use is covered separately by the assessments of Health Canada, under their novel food guidelines, but with close collaboration with Agriculture and Agri-Food Canada. Agriculture and Agri-Food Canada makes available information about the field trials of biotechnology-derived plants that are assessed, and decision documents explaining the rationale supporting the decision to approve commercial-scale trials are also published and widely distributed. To date, 14 such decision documents have been developed.
The Feeds Act and its regulations govern the manufacture, sale and importation of livestock feeds and feed ingredients in Canada, regardless of the method or process used to produce them. It's designed to protect farmers, their livestock, the environment and the general public against potential health hazards associated with the products, while ensuring that the product is effective. The act provides the authority to write regulations detailing information requirements for product registration, and for prescribing the form, composition and other standards for feeds.
Feed product types include living microbes that help maintain healthy bacterial populations in the animal's stomach and provide additional nutrients, fermentation products such as amino acids and vitamins, microbes such as forage additives for improved hay and silage, and new plant types used directly as livestock feeds.
The regulations require the submission of information to permit assessment reviews focusing on toxicity to livestock, human safety in terms of the transfer of harmful residues to human foodstuffs, safety of workers handling feeds, and safety to the environment. Anti-nutritional effects, irritation and allergenicity are some of the considerations evaluated. The review process includes close links on the environmental assessments of biotechnology-derived plants under the Seeds Act with Health Canada, which assesses the safety of food for humans.
To date 14 new plant types have been approved for livestock feed in Canada, in addition to the various approvals for 141 microbial products. None of the microbial products were genetically engineered, Mr. Chairman.
Mr. Chairman, I've already used up ten minutes. I'd be quite happy to stop here and consider the rest of the document as read, since you have it as distributed material.
The Chairman: Would you mind completing your presentation?
Dr. Morrissey: The Fertilizers Act and its regulations provide authority to asses the safety of fertilizers and supplements with respect to safety of humans and the environment, including plants and animals, and to determine that they are efficacious. Biotechnology-derived fertilizer product types include micro-organisms that provide plants with nutrients they obtain from the soil or air that would otherwise be unavailable to the plant. This reduces or eliminates the need for manufactured chemical plant foods.
The safety assessment focuses on the identification of the organism and its behaviour in the environment such that its relationship to any organism that could cause adverse health effects. Assessments are conducted regardless of the method or process used to produce these products. If the micro-organism has been modified by genetic engineering, a full evaluation of the process is carried out. There is close cooperation with Health Canada in these reviews, since the use of these products on food plants is common.
Close to 100 microbe-type supplements are currently registered in Canada, none of which have been genetically engineered. Since 1993, 162 research trials have been authorized. Two were of genetically engineered products, one in 1991 and the other in 1996.
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The Health of Animals Act and Plant Protection Act control the importation of plants, micro-organisms and animals by way of import permits. Import permit reviews examine the potential for a new imported plant, animal or micro-organism to have adverse effects on human safety, animal safety and the environment. The requirement for import permit reviews applies to all organisms that could be injurious to animals, plants or their ecology regardless of the breeding method or process used to produce them. Genetically modified organisms are equally subject to scrutiny under these acts, as would be an exotic animal or plant species not native to Canada.
In addition, the Health of Animals Act and regulations specifically provides authority to regulate the production, importation, field testing and registration of veterinary biologics in Canada produced by modern techniques of biotechnology, or by traditional methods. Veterinary biologics include products used to diagnose, prevent or treat animal diseases.
To license a veterinary biologic, applicants must provide data to prove the safety - human, animal and environmental - purity, potency, efficacy and stability of the product. A risk-based approach is used that applies equally to biologics produced by conventional and genetic engineering technology. If the product has been developed through genetic engineering, the assessment will include a review of the characteristics of the parental and recombinant organisms, as well as the method used to accomplish the genetic modification.
For certain products the evaluation of a veterinary biologic such as a vaccine may involve other federal departments, such as Health Canada and Environment Canada. Similarly, the Department of Fisheries and Oceans may be involved in the evaluation of fish biologics.
To date a total of 41 biotechnology-derived veterinary biologic products have been licensed. Thirty-three of these are diagnostic test kits, such as for animal diseases, and the rest are vaccines for viral and bacterial diseases. There are 14 diagnostics kits and 9 vaccines currently undergoing licensing. The environmental assessment for a new type of rabies vaccine, an oral bait vaccine for immunizing racoons, has now been completed. Safety of this vaccine was evaluated jointly by Agriculture and Agri-Food Canada, Health Canada and Environment Canada.
In an effort to make information concerning the Seeds, Feeds, Fertilizers, Health of Animals and Plant Protection Acts, as well as on the department's regulatory system, widely available, Agriculture and Agri-Food Canada maintains a site on the Internet. This site includes information on regulations, guidelines, consultation documents, lists of field trials, and decision documents for products that have been approved. This constantly expanding Web site, known as InfoAgBiotech, also provides basic information concerning biotechnology in agriculture, news of departmental activities and contacts within the department.
Thank you Mr. Chairman.
The Chairman: Thank you, Dr. Morrissey. This is very helpful. Who is the next speaker?
Dr. Morrissey: We only have one set of opening comments, Mr. Chairman.
The Chairman: That was parsimonious this morning. What's the matter with you?
Dr. Mahon, do you have any comments?
Dr. Desmond Mahon (Chief, New Substances Division, Commercial Chemicals Evaluation Branch, Department of the Environment): At this point I do not. Thank you.
The Chairman: Mr. Mayers?
Mr. Paul Mayers (Acting Chief, Evaluation Division, Bureau of Microbial Hazards, Department of Health): No, thank you. We have no opening remarks, Mr. Chairman.
The Chairman: Do you?
Ms Margaret Kenney (Associate Director, Biotechnology Strategies and Coordination Office, Department of Agriculture and Agri-Food): No, thank you.
The Chairman: It's an astonishing performance. We have lots of time to start.
Madam Guay, would you like to go first?
[Translation]
Ms. Guay (Laurentides): I have a few questions I would like to ask you about agriculture. You mentioned fertilizers and a number of other things, but you did not mention pesticides.
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I would like to know who establishes regulations for pesticides. Is it Agriculture Canada?
Mr. Morrissey: Up until roughly six months or a year ago, it was the Department of Agriculture. Since then, the task has been transferred from the Department of Agriculture to the Department of Health. A remote agency was set up under the supervision of the Department of Health.
Ms. Guay: So Health Canada establishes regulations for pesticides. How do you come to an agreement, since you establish regulations for fertilizers? The work has to be done jointly, as the two go hand in hand.
Mr. Morrissey: There is a clear cut distinction between fertilizers and pesticides. Fertilizers are plant nutrients, whereas pesticides are used to destroy insects that are detrimental to plant health. So the distinction is quite clear. However, there is cooperation between the two departments, as you saw in the case of the rabies vaccine for raccoons.
Ms. Guay: Is there the same cooperation with the provinces? Does the federal Department of Agriculture do any work with the various provinces?
Mr. Morrissey: Yes. For example, with the vaccine for raccoons, the provinces cooperated closely with the Department, especially Ontario, because from what I understood, the threat for this strain of rabies came from the United States, and Ontario was the province that was the most at risk.
Ms. Guay: So the work was done in conjunction with the Ontario Ministry of Agriculture and the federal Department of Agriculture.
Mr. Morrissey: There is cooperation at the federal-provincial level, and not only with the Ontario ministry. In this specific case, it was with the Ontario ministry.
Ms. Guay: Recently, there has been a lot of talk about biotechnology. Several people have told us that Environment Canada must act as a safety net if decisions are to be taken by various departments. I would like to hear your views on that.
Mr. Morrissey: I think there is consensus among the various departments for the Department of the Environment to act as a safety net. I think there is also an agreement among the departments to ensure that there is no duplication in legislation and regulations once the safety net has been implemented.
Ms. Guay: Can you give me some information on bovine somatotropin? Where are we with that?
Mr. Morrissey: Once again, this is a matter that does not fall under the jurisdiction of the Department of Agriculture and Agri-food. I would like to start with a short comment and then I will give the floor to my colleague, if I may.
As far as I know, the Department of Health has requested additional information regarding animal health. As far as I know, this data has not yet been tabled, or it has been tabled but it has not yet been fully assessed. At any rate, Health Canada is still reviewing the matter and no decision has been made as of yet.
[English]
Mr. Mayers: With regard to BST, the issues surrounding it at present relate to the review. As noted by my colleague, that review is still ongoing and Health Canada will not be in a position to make any decision regarding that product until the review has been completed. Until that time, the product cannot be used in Canada.
[Translation]
Ms. Guay: Can you give us an idea as to how long it will take to obtain the results of these reviews?
[English]
Mr. Mayers: Unfortunately, I can't give you an approximate timeframe, because it is dependent on the nature of the information the proponent of the product submits for review. And because Health Canada believes it needs to take whatever time it requires to do a complete and thorough review, we have not set any specific timetable for that review. We believe that review needs to take whatever time it needs to be complete and thorough, prior to making a decision.
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[Translation]
Ms. Guay: In your view, will the fact that the United States has already put BST on the market have an influence on Canada's decision, or will Canada remain totally independent in that respect?
[English]
Mr. Mayers: The decision will be independent. The product has completed review in the United States and has been on the market for quite some time, but Health Canada has not been influenced by that decision. We still had questions for the proponent and they have to provide data to address them. Therefore, that review continues to be ongoing in Canada, so it is indeed an independent review.
[Translation]
Ms. Guay: Thank you, Mr. Chairman.
The Chairman: Thank you, Ms. Guay.
[English]
Now we will hear from Mr. Lincoln, followed by Mr. Knutson, Mr. Steckle and Mr. Adams.
Mr. Lincoln, please begin.
Mr. Lincoln (Lachine - Lac-Saint-Louis): During the course of these hearings, we've been discussing the objectives and priorities in regard to biotechnology. We've been discussing which should come first. I think there's been a general agreement on the part of the witnesses that human health and environmental safety should always be the paramount considerations.
Last night I saw a television news report - of course, we have to take it with a grain of salt, I don't know how exactly correct it is - in regard to the pesticide content in wine products. According to what I heard, in Canada it is now one of the lowest in the world. It's 1% of the total content of a wine bottle.
Now in Canada the health ministry is proposing to increase this 2.5 times, on the basis that competition around the world demands it because our competitors allow for 2.5% pesticide residue in wine. The motivation of those who were interviewed - certainly of the winery people - seemed to be that they were delighted because this would make us competitors on the world market, and that in fact the world trade provisions would almost force us to do it.
This leads us to question again what the paramount motivation is. Is the paramount motivation trade and the fact that competitors are acting a certain way, or does it continue to be human health and environmental safety in all our departments? Could you tell me if you're aware of this? And what motivates a decision to possibly increase...? I know there'll be a period of public notice, but at first, apparently, this is the thrust of the decision of the health ministry.
Mr. Mayers: The issues surrounding residues are regulated under the Food and Drugs Act and regulations. Residue limits are set based on safety thresholds. Therefore, a human health consideration is the basis for pesticide residues.
Within our requirements under the World Trade Organization, any limits we set that are different from internationally accepted limits must be defensible based on science. So a consideration of any residue limits that in Canada are different from the international limits would have to be based upon a risk assessment for that particular compound in terms of human health. Before any changes would be made, a risk assessment would be conducted to give consideration to whether or not limits could be changed without compromising human health.
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Mr. Lincoln: So again the onus seems to rest on the safety side, having to prove to the World Trade Organization and its people that the higher threshold is just as safe as the lower threshold. It would seem to most lay people, anyway, that in the case of pesticides, which are highly toxic and are causing so many unforeseen problems - certainly at one point we used to think DDT was great - the lower threshold would be certainly much safer than the higher threshold.
So in effect, from what you say, it's for us to assess and prove that the higher threshold is still just as safe as the lower threshold. Is that really what it is?
Mr. Mayers: There are two considerations.
Under the food and drug regulations there is provision for a generic residue limit of 0.1 parts per million, which all agricultural chemicals have to meet unless there's a specific limit in the regulation that is higher. So the risk assessment allows for the specific safety tolerance of a particular compound to be determined, and if that safety tolerance is greater than 0.1 parts per million, then it would be permitted at that level.
The 0.1 parts per million is a generic limit, which therefore allows for the use of agricultural chemicals to a certain level, where the food would not be adulterated once the residue were below that generic limit of 0.1 parts per million. But there is provision for specific compounds to be assessed regarding their toxicity to determine a specific limit for that particular compound.
Mr. Lincoln: But do you agree that the assessment, as we've discussed before, is related to the science we know today?
Twenty years ago our tolerance assessment placed lead at a far higher threshold than we would today. We took it out of gasoline because we suddenly found out the thing was just so toxic that it caused cancer and all kinds of things.
What if we suddenly found out that 2.5 times the tolerable limit, whatever the relative limit is in wine, caused a lot of problems? Wouldn't it be just too late then to move from 1% to 2.5% and then find out that after all everybody was wrong and the threshold was too high? Shouldn't we just fight the World Trade Organization to prove that safer is better, the ultimate safety is always best?
Mr. Mayers: Safety certainly is our interest, and that is the focus, but we do at the same time recognize that there remains the potential to give consideration to compounds on their own merit. That is the thinking applied. My colleague Dr. Morrissey -
The Chairman: [Inaudible - Editor]
Dr. Morrissey: Thank you, Mr. Chairman.
I'll make a general comment that probably applies to all of the acts that relate to the animal kingdom, including humans, and the plant kingdom. Pretty well all of the acts in this country are set up based on requirements for safety, efficacy and fraud. The words change a little from one act to the other, but the principles demand safety, efficacy and fraud, based on the best knowledge available and based on reasonable grounds.
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That principle, again to the best of my knowledge, has been recognized by the World Trade Organization. One of the few acceptable general barriers to trade is on grounds of safety, for example. If a country has reasonable grounds to do something different from the rest of the world on the basis of safety and can present that reasonable evidence, then it's considered a valid reason under the World Trade Organization for doing different things to protect safety in your own country.
There are some reference bodies around the world on what are reasonably accepted international standards in relation to safety, for example. In the area of animal diseases and their movement it's the International Office of Epizootics. In the area of plants it's the North American Plant Protection Organization and EPPO, the equivalent organization in Europe. In the area of food safety it's Codex, which you've heard about several times before this committee.
The last little comment is that when new evidence becomes available, there is an onus on government agencies to re-examine and perhaps make a new decision.
The Chairman: Excuse me for barging in. The system seems to be driven by evidence and not by the precautionary principle.
Mr. Lincoln: This is exactly the point I was trying to make. At one point our judgment in Canada, according to health authorities, was that a certain threshold was safe. The reason we re-examined the threshold - and this is what I'm trying to drive at - was not that we ourselves suddenly discovered that our safety limits were wrong from an environmental or human health point of view, but the competitor out there has a higher limit driven by trade reasons. So we have to use that, not to say ours is best and the World Trade Organization should go down to 1%, but we have the onus to prove that 2.5% is not unsafe.
It is a very different objective, in my view. One is the precautionary principle that drives all environmental health and ecosystem health. The other is to say, fine, all the nations of the world and the big wine producers, which suits them obviously... The big wine producers have tremendous clout in WTO because they produce probably 90% of the stuff. France, Italy and the others have been using 2.5%. We, who have taken the safest possible alternative, then find ourselves having to prove that 1% is too much. Then we have to move to 2.5%. When we find that 2.5% maybe is too high, then perhaps it's too late and something has happened.
Dr. Mayers, don't misunderstand me. I'm not criticizing you personally. I'm just saying that the whole motivation of our system eventually seems to ignore the maximum safety assessment.
I'll close with this because I have to leave my colleagues to ask their questions. On assessment, Dr. Morrissey, right now CEPA provides that all products that are regulated, assessed and notified for import purposes or manufacturing under specific acts don't fall under CEPA. But if they are not, then CEPA rules. What happens in the case of guidelines? It seemed to me that Dr. Bailey was saying the other day that we're using more and more guidelines. What is the statutory requirement to assess as strictly under guidelines as under regulations? What happens if one of the specific ministries that produces guidelines and not regulations decides to assess much more loosely or not at all? What is the statutory requirement when they have chosen to go to guidelines to assess?
Dr. Morrissey: There are two questions, as I understand it, Mr. Chairman: one on the precautionary principle and one on guidelines versus regulations.
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On the precautionary principle, my sense of what's happening is that, speaking for the animal acts and the plants acts that I'm most familiar with, they have been written for the last 100 years using what I believe to be the precautionary principle; the absence of perfect knowledge is not an excuse for doing nothing. They are written in the sense that if the minister suspects a disease, which is a deviation from health, and if it's a reasonable suspicion - a suspicion, not a proof - then the minister can take action.
In very many cases in animal and plant diseases where you do a serum test, it's a proxy test; you're not really looking at the causal organism. So you have no more than a suspicion, but action is taken based on that suspicion in every case.
Once the precautionary principle is used and once new information comes to hand, the new information may indicate that we have been over-cautious or that we have not been cautious enough. That permits a new decision to be made, which could be a loosening of tolerances or a tightening of tolerances.
The second comment is on CEPA guidelines versus regulations. My sense of the guidelines and regulations issue is that just about every government agency in the world uses acts, regulations, and some other document. Sometimes the other document is called office directives, directives to industry, manuals of procedures, or guidelines. They tend to be how-to documents. In my experience with them we quite often start out by putting guidelines out, and in those areas where we either don't get compliance or we find the risk is higher, they move progressively into regulations.
To answer your question directly, my sense is that if we found that there was something in a guideline that wasn't being complied with or that should be put into a regulation, then it would be put into a regulation.
Mr. Lincoln: That wasn't my question, Dr. Morrissey. I understand the progression. If you have guidelines prior to regulations, do you assess the same way as regulations and statutes force you to assess?
Dr. Morrissey: If you examine the regulations that are now at the about-to-be-published stage for agriculture, they call for basic tombstone data for a notification and for assessment. In other words, the basic tombstone data is the what, who, when, where, why, and how of that particular entity. Based on that information a decision is based on familiarity and substantive equivalence. Based on how familiar we are and how substantially equivalent the data and the entity are, new information may or may not be called for.
That's the basis for the notification and the assessment. The assessment in every case is the same in the sense that the product must be safe and efficacious to be released. How much new data you require is the only variable, entity by entity.
Mr. Lincoln: Is it the same for guidelines as it is for regulations?
Dr. Morrissey: I'm saying in the regulation right now -
Mr. Lincoln: I know that, Dr. Morrissey. What I'm asking is if you have guidelines instead of regulations, do you use notification and assessment provisions then?
Dr. Morrissey: In the case you've asked about we don't have guidelines instead of regulations. We have regulations that call for notification and we have regulations that call for assessment. The guidelines provide greater detail and greater clarification. In the sense of the information that must be provided, the tombstone data, and the ability to call for further data, that's in regulations.
Mr. Lincoln: I'll come back to it later on. Thank you.
The Chairman: Thank you, Dr. Morrissey.
Dr. Mayers, would you like to conclude this round?
Mr. Mayers: Yes, perhaps with a note of clarification.
The guidelines that are being used, both in Health Canada and, to the best of my knowledge, in Agriculture, are not independent of regulations. The guidelines are intended to interpret regulations. So the guidelines themselves act within the regulation in terms of interpretation. Therefore, in agriculture, non-compliance with the guidelines in essence would result in non-registration of the product and would therefore have the same force because they operate under the regulation to interpret that regulation.
The Chairman: So what you are telling us is that the guidelines are in a lower hierarchy than the regulations.
Mr. Mayers: Yes. They are in a lower hierarchy, but they have the force of providing greater guidance to industry in terms of how to comply with the regulation.
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The Chairman: Thank you, Mr. Mayers.
Mr. Mahon.
Dr. Mahon: I would like to comment on the comparison between guidelines and regulations, and the comparison to CEPA, the precautionary principle.
As I think the committee knows, the precautionary principle is ensconced in CEPA as a principle on which the act is based at this point. Coupled with specifically-for-biotechnology products, the statement of the provisions of the assessment is that a product that either does have or may have...and that by definition implies the application of the precautionary principle in that you must identify whether or not it may have an adverse effect and take action based upon the may, which is the precautionary principle.
I should state that at this point the four agriculture acts that Dr. Morrissey has talked about ensconces those same provisions in regulations. They are the end point of the assessment. The draft acts I know of at this point identify that the minister must make an assessment of toxic as defined in CEPA, which includes the have or may-have provisions. How one reaches that conclusion is variable from product to product. Under CEPA, by the definition, by the requirements of the act itself, we must put all of our information requirements in regulations, as I think you know.
There is a discussion between the two departments - and it will eventually be going public - for consultation as to what mix of regulations versus guidelines should be used in all other acts.
I see Mr. Lincoln's point as to the legal basis. The statutory requirement of a guideline implies that there is no variability. The difference is that within CEPA there is variability. There is a waiver provision within CEPA that would permit people to not have to submit the information, but it has its own steps. The notifier must identify and request permission not to provide the information.
That is not as clearly announced in the agriculture acts, but there is a variability between the two acts that I think can be accommodated. One can reach the same degree of certainty. The critical point is that one must reach the same end point. The end point is the same between the agriculture acts and CEPA. The clarity of how one reaches it, I agree, is a matter of discussion. Thank you.
The Chairman: Thank you. That's very helpful.
Next is Mr. Knutson, followed by Mr. Steckle, Mr. Adams, and Madame Payne.
Mr. Knutson (Elgin - Norfolk): Thank you very much, Mr. Chairman.
As I've indicated before, I'm a relatively new member to the committee, and I wonder if you could briefly apprise me of this new regime of regulations that's about to be published. In a general sense, how will they increase our environmental security in comparison to the current regime?
Dr. Morrissey: Thank you, Mr. Chairman. I'll try to make an opening comment on the question and then pass it to Margaret Kenney, if that is acceptable.
Two steps are being taken on regulations to extend - if I could use CEPA terms - the assessment of new substances. Traditionally these have been new biological entities coming in from outside the country, or for example, new vaccines manufactured here, to make it clear that the existing acts and regulations apply to new substances of new biotechnological origin. We have already done one piece of regulatory change, which is to include the definition of biotechnology in the regulations to make sure there's no doubt that it is included. The second lot are to provide detailed or more detailed requirements on the information to be submitted for environmental assessment.
Ms Kenney: As Mr. Mayers had explained a little earlier, we see the guidelines as falling under the regulations ultimately. But at this point in time, without having the regulations actually in place, we are working solidly with guidelines alone. That means some of the industries we're working with are working on a voluntary basis. That's why it's very important that we move these regulations forward into the gazetting process so that we're no longer working on a voluntary basis but that our guidelines are firmly under established regulations.
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Mr. Knutson: Let me move to another point. I brought up the issue of the testimony of Professor Leiss from Queen's University. My sense was, to paraphrase, that he made basically two theses.
One was, for example, when we introduce a scorpion gene into a virus to fight budworm, we're doing something so radically different from traditional science, from what Mendel did in the monastery in terms of selecting flowers - I can't remember what it was...fruit flies, or whatever - moving genes from one organism to another, regardless of how cautious we are... Because we're on the cutting edge there's an element of not knowing what we don't know; we're taking a leap in terms of risk.
That's more a comment on the nature of risk - and it flows out of the fundamental issue of the nature of knowledge - than it is about...
I guess he goes to the fundamental question of what is science. That's one of, I think, two main arguments he makes. Because we've moved into an area of greater risk, we need to look at a new regulatory regime, and perhaps he goes so far as to suggest a new act that just deals with transgenic materials.
I wonder if I could have your comments on that.
Dr. Morrissey: Thank you, Mr. Chairman. I'll perhaps make comments on both issues, if that's acceptable, and then ask if my friends at the table would like to enlarge on it.
On the first comment about the scorpion-virus link and using it to fight spruce budworm, I have two subcomments. One is that Bill spoke about the four phases of biotech that I had outlined when I spoke to this committee some time ago. I mentioned that in his mind he would not only have separated them into four paragraphs as I did, but more distinctly separated the last phase, which is transgenic biotech, what we're speaking of here. That's a perception, and I respect those perceptions.
My personal sense is that if this committee had asked me where I would have drawn the line, I would have drawn two lines. I would have drawn one line where humankind first started to breed plants, of where we moved from having strawberries that were as big as my nail to strawberries that may have been this size. My personal sense is that back when that first started that probably was seen as a change of enormous proportions. That's where I would have drawn the first line.
Mr. Knutson: When was that? At what point did they do that?
Dr. Morrissey: I'm guessing - maybe 10,000 years ago, a long way back.
But my sense was that in terms of change of those four steps, if I had been asked where I would have drawn the line I would have drawn the first line there.
The second line I would have drawn was when Crick and Watson and Jacob and Monod came up with the basis for genetic engineering, the principle of moving one gene rather than moving 20,000 to 50,000 genes, a precision of work. I wouldn't have draw a subset between species and across species, partially because the evidence that now seems to be coming to the fore - with the complete mapping, for example, of the yeast genome - is that we are far more similar, not just amongst ourselves but between yeasts and humans, for example, or yeasts and plants, than anybody could have suspected 10 years ago. It looks like all of these genes came from something that was quite common and remained quite similar, so our converging pool of genes may be going back to a place we came from and still remain fairly close to.
The second comment I would have made is around the recommendation Bill made on a new transgenic act. If you read books on organizational design like Hodgetts on the Canadian state, he speaks of principles of organizational design where you have four primary choices, four ways you could design or organize the regulation of biotech.
One is by product. The Government of Canada tends to have organized itself around product departments: agriculture, fish, forestry, mining, and so on.
One would be process. You could have a department of science, a department of biotech. You could organize that way.
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Another one is place. You could have a department of northern affairs.
Another one is people.
Those are the four Ps. You could have a department of justice where all the lawyers are in one department. But the key point is that having organized yourself under one of those headings, you now are not organized under three of those headings. You have three rough interfaces and you have a coordination job on those three interfaces.
What the Government of Canada seems to have done primarily is to organize around product, because they then give ministers control over all the tools necessary to control that product. For example, if an environment minister is put in charge of a certain domain in the environment, that minister has the biotechnologists or the entomologists or whatever else is required, but other ministers also have access to science to deliver their programs.
The point I'd make in relation to Bill's suggestion is that he didn't respect any of those principles. He didn't organize by product, place, process or people. He suggested organizing by a subset of process. In other words, one part of the biotechnology process that related to transgenics would be the subject of a separate act, separate regulations, separate staff and a separate agency. So not only would you have three coordinating jobs - which you would have in any of the traditional ways of organizing - you would have added a fifth one, a fifth dimension.
Mr. Knutson: I'll come to that. It's the second part of my question. But at least as I read it, his argument is based on two cornerstones. The first is that transgenics, because they're novel, represent a higher risk, and my sense is that you don't accept that as a starting point.
Dr. Morrissey: I wouldn't accept or deny it. My sense is that any of these new entities are new by definition. Some of them may have significant risk, bred by traditional means, and some may have lesser risk. I would go back to the original intentions of these acts that have served us fairly well for about a hundred years. They're looking at any new entity and they're looking at its safety, its efficacy and its fraud.
Mr. Knutson: At times, whether it's Watson or Crick or the development of the nuclear bomb, we make quantum leaps. For example, we could have a regime to look at weapons. We could take a continuum up until the 1940s or whatever, and say, we went from gunpowder to bigger gunpowder to whatever and whatever, and then we came up with the nuclear bomb. And I think you would agree that you wouldn't have the same regulatory regime about storing weapons prior to the nuclear bomb and you wouldn't have the same rules applying to nuclear bombs, because we have made a quantum leap. I guess his point is that we've made a quantum leap that's big enough to raise the risks.
Dr. Morrissey: Maybe I shouldn't dominate the conversation. Would anybody else like to comment?
Mr. Knutson: Mr. Mayers?
Mr. Mayers: Thank you, Mr. Chairman. The introduction of the ability to move single genes as opposed to thousands and thousands of genes is viewed by some as a quantum leap. And most consider that the quantum leap is not the fact that you can do it precisely, it's where you can get those genes from. As you mentioned, you can go outside of the species.
But I think my colleague's comment with regard to the fact that there is much more similarity among species than there are differences among species is also important, because what it speaks to is the fact that our genetic material is in fact the same. Therefore, the genetic material from a fish, a plant, a bacterium or a human is always the same, and in many cases that genetic material even codes for the same enzymes, regardless of the species it's in.
Because of that similarity it lends some predictability to the situation. To use your example, we know how that DNA that comes from the scorpion will work, because regardless of its source, DNA is the same. There is a measure of predictability. Therefore, that allows the safety assessment to consider that development as it has considered other developments that may be more intraspecies.
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Dr. Mahon: First, Mr. Leiss communicated about risk - two different types of risk, I think.
The first was what we call the scientific risk assessment, the risk of a product. However, I think many of his comments were based on the second risk - the risk to public confidence, to the government, to policies and to economics of the loss in public confidence, because they are incredibly concerned about transgenics in particular. I believe that is a very high risk in Mr. Leiss's mind, and may well give rise to discussion as to why he would recommend a separate entity.
If I leave that one aside and go to the risk of a transgenic - if you take a well-known organism like canola, and one has done an assessment of that and the plant or the product is now out in the field, there is an established level of risk. When one puts a new gene into a plant or into an organism of any kind, there are three things that can happen.
The first is the actual gene. If you put in a gene that codes for a toxin, you have an identified risk associated with that toxin. That must now be brought into the risk assessment. But two other things could possibly happen. By putting in the gene you may inadvertently give rise to either activating or inactivating something else in the plant. This is the unforeseen risk. Yes, there is a finite possibility that could happen, but the consequence of that is foreseen in that if you change the biology of the organism by inactivating a significant component in it, it shows up in the testing. It shows up because the biology of the organism changes, so there is a diminishing possibility that something totally unusual will happen.
It is never zero but it gets smaller as you know the biology of the organism you are dealing with. One accumulates those at that level of risk, and I think this is what Dr. Morrissey meant when he said that as we know what we're doing, we add more information requirements to be able to say, if this happens, maybe we should look at this just to check.
Mr. Knutson: Let me move to what I thought was his second point - which government department should have authority over these substances.
The basic argument that I heard was that there are certain ministers, ministries or departments that have economic development as their primary purpose - Industry Canada would be one, Agriculture Canada would be another - and as such they will not give the same paramountcy to health concerns as the Department of Health might, or to environmental concerns as the Department of the Environment might, notwithstanding their best intentions.
When a minister comes to work every day and says, my job is get the unemployment rate down, or to increase agricultural exports from $14 billion to $20 billion, he or she comes to work with a different mindset than the Minister of Health might come to work with. That's not a knock on anybody in the job currently or in the past, it's just the nature of people and organizations.
His point is that if we're going to make health the paramount concern, then the introduction of new materials into our society should be under either the Department of Health or the Department of the Environment, but not someone with an economic agenda, notwithstanding that the economics of it are very important.
Dr. Morrissey, I would like your comments on that.
Dr. Morrissey: Thank you, Mr. Chairman. I have perhaps three comments.
First, I understand that pretty well all of the product departments in the Government of Canada - the agriculture, fish, forestry and health departments, and so on - have a mandate that is a subset of the mandate of the Government of Canada. It is something along the lines of being conscious and working for the well-being of Canadians in their particular segment.
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Health Canada, for example, promotes human health, so they have a role in promoting the well-being of Canadians in relation to their health, but they also have a regulatory role in regulating human health vaccines, for example. Similarly, the Minister of Agriculture is seen as having a subset of the well-being of Canadians insofar as it relates to the well-being of safe and secure food supply, stewardship of the soil and so on. But that minister also has a responsibility with regard to safety of animal vaccines, for example. If you go to Environment Canada, that minister has a similar social responsibility for the well-being of Canadians in their environment, but may also be seen as being the spokesperson for the environmental community or having an interest in developing a pollution control industry, for example.
So most of the ministries that come to mind for me have these two functions, and I don't see the well-being of Canadians as being of necessity in conflict with the development of vaccines that might promote their well-being.
The other point I'd make is that in promoting their well-being, whether the health of soils, crops, animals or humans, only three techniques are really available to anybody - the physical intervention, the chemical intervention and the biological intervention, whether it's a health care product for humans or for plants. The state of knowledge now seems to be that it shouldn't be any one of those, that none of this would likely promote a lone physical, chemical or biological control method.
In the area I'm most familiar with we speak of integrated pest management. You use all three of them in a way that's of the least interference to nature as possible.
The last comment I'd make is the acts that have been given by Parliament to these ministers - certainly to my minister in Agriculture - relate to safety, efficacy and fraud. Those are the specific areas that Parliament has charged the minister with, and I assume for which it will hold the minister and those of us employed there accountable.
Mr. Knutson: Do you think it made a difference to move the regulation of pesticides from Agriculture Canada to Health Canada?
Dr. Morrissey: I was reading the transcripts on the pesticide issue. I was involved in that at the time it occurred, so I know some of the history of it. Or at least I have perceptions of what happened, because I sat around the table.
My sense of what happened at that time was that a particular important pesticide was taken off the market. It was required by the agricultural community and there was a sense of disappointment that the Minister of Agriculture had not maintained that pesticide on the market for the agricultural community. So it was the agricultural community itself that asked for a review of the registration process of pesticides. From where I sat their perception was that the minister was not sufficiently sensitive to their needs, which is the opposite of saying the minister was in a position of conflict of interest.
Once the file was opened, my sense was that one group in Canadian society felt that pesticides should not be regulated by Agriculture, another group felt uncomfortable if they were to be regulated by Environment, so the compromise solution was Health Canada.
Mr. Knutson: And in your view...?
Dr. Morrissey: Are you asking whether this was my view?
Mr. Knutson: No, I'm asking whether in your view it was a good thing?
Dr. Morrissey: Yes, it was at that time, because the parties who were affected by that decision, who had a stake in the logic of it - was it logically a right thing to do - and were affected by it - was it acceptable to various interest groups in society - were represented around the table at the pesticide review process. Because there was consensus among Canadians - that representative group of Canadians, at least - as to where it would go, that makes it hard to argue against.
Mr. Knutson: But your justification seems temporary in that it was only based on the factors that were brought to bear at that particular time. I'm asking whether in the long term it makes sense in your view that pesticides be governed under Health Canada?
Dr. Morrissey: Mr. Chairman, to go back to first principles, you could organize by place, by product, by process or by people. In this particular case it's being put in the Department of Health, I suspect for reasons of product in that case.
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I suspect the product link in people's minds was to human health, that this was an agent that in the last analysis could impact on human health. If you think of the acts they're related to safety - another word for health - efficacy and labelling. My sense was that at that time they were looking primarily toward human health rather than agricultural health - health of soils, crops and so on. So you could have made a case either way. You could of made a case for crop health or for human health in terms of human exposure and residues in food.
Mr. Knutson: So in terms of 1996, at least, it really doesn't matter.
Dr. Morrissey: I would say it mattered very much.
Mr. Knutson: But I mean in terms of now.
Dr. Morrissey: No, I would say it still matters very much. It matters in the sense of what Canadians feel are the primary benefits offered by this particular technology, and what are the costs. What is it they want to be protected against? The consensus from that group was primarily around health issues. So that was the logic half of the equation, but I think the acceptance half is also an important half. From what I could see, there were parties around the table who were uncomfortable with Agriculture or Environment regulating and who felt more comfortable with Health regulating.
Mr. Knutson: Just to go back -
The Chairman: Mr. Knutson, on the second round.
Mr. Steckle followed by Mr. Adams, Mrs. Payne, the chair, and then we go for a second round.
Mr. Steckle (Huron - Bruce): I'll address my question to Dr. Morrissey.
We have three ministries at the table this morning, and it is not the first time you've been here. I bring a rural perspective to my questioning. I assume the agricultural community would want someone at this committee to bring forward some of the issues.
One issue that surfaced just recently - and I regret that I didn't bring the document with me this morning - is the view toward changing the labelling of anhydrous ammonia, a form of nitrogen used by farmers. From it being a corrosive product to one of being poisonous - this has some serious ramifications in terms of perception.
If we see a tractor pulling an anhydrous tank down a concession road and we see poison labels on the side of the tank, what are we saying to our community? This product has been transported up and down our roads, and it can be a hazardous product if it's not carefully handled, but it certainly isn't considered poisonous as we might consider other products poisonous. I understand this is now being handled by industry. How has this come to be, if indeed it is coming to be, and how do we get it back on the table and have this issue reversed to a sensible conclusion?
Dr. Morrissey: Mr. Chairman, I am not aware of this issue so I'm not qualified to comment on it. Perhaps my colleagues are aware of the file.
Ms Kenney: Just on the edges, I'm afraid. We understand that this matter is currently under discussion with Environment Canada, and we're looking forward to a good conclusion in the near future. That's all that I know about it at this time.
Mr. Steckle: You say a good conclusion, but on whose side is the conclusion coming down? A good conclusion for an environmentalist, or for someone who is concerned about this being labelled a poisonous product, might be a different conclusion from what I would want on that product.
I speak for thousands of farmers when I bring this to the table. If you're not familiar with the subject, please become familiar with it and let's address this, because this is not something to treat lightly. This is very serious, probably as serious an issue as anything we've discussed.
We are talking of a lot of theory here. At the end of the day I'm not sure we have a total consensus. We have disagreement on some issues that we still haven't come together on. In terms of last month's discussions on biotechnology, we still haven't concluded that we should do it this way or do it that way.
Anyhow, we have ministries here this morning. On the pesticides issue, the Department of Agriculture is committed to do the pesticides review, making it easier for farmers to have registrations done more expeditiously, and where the U.S. is registering products we don't have a doubling up of that. We need to ensure that there are all kinds of safeguards in there, but we should not be doing the work over and over again. The agriculture department is committed to that. We've made those commitments in our election promises to the farmers of Canada.
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Now we have Health Canada involved. How can we see this process coming to what we believe is the logical conclusion and having products registered more quickly when we now have two ministers, one with a commitment to the Canadian people and the other with other stakeholders' interests, to a greater or lesser degree, at heart? How do we bring this together?
Dr. Morrissey: Perhaps I could make an opening comment, Mr. Chairman, and then one of my colleagues could provide greater detail.
When pesticides were with Agriculture we approached the United States, not to have identical decisions on pesticides but insofar as the objective scientific assessment of the health and safety aspects of a pesticide was concerned, to see if we could share the workload on that front. Our sense in the early days was that the United States was less interested than we were. We were a small player; they were a big player. My sense is that we perhaps needed them more than they needed us.
However, about the time President Carter become personally involved in attempting to get NAFTA through the legislative process in the United States, we at the working level noticed quite a difference in the reaction we got from our opposite numbers in the United States. They became much more interested in cooperating with us.
That's as far as my experience went. At that stage I was no longer involved in pesticides and the file moved to Health Canada. Perhaps I could ask if Paul and my colleague from Environment, Des, have any further comments.
Mr. Mayers: With regard to pest control products, certainly there has been a spirit of collaboration between us and our colleagues in the major trading areas, particularly the United States. In several areas, in the actual development of guidelines for specific requirements to assess products, they have been developed in consultation with experts not only from Canada but from the United States and Europe. They were involved in the discussions with an interest in harmonizing requirements to the extent possible so that a proponent of a product could develop a single data package to address all of the constituencies in which that proponent wanted his or her product registered.
Dr. Mahon: I could use an example from a different area I have responsibility for, which is new chemicals. We started an activity three years ago to try to get cooperation within the United States to enable them to send us their assessments, not the conclusion but the assessment of a new chemical. Because of the legal framework in the United States it has taken three years to get an agreement. If they release it to us, we're a third party and that opens up their file to everybody in the United States again. It's taken a phenomenal amount of time to persuade the American industry to give permission to the American government to send their assessment to us to use.
To get to harmonization and to cut out duplication, you have two requirements. The first one is that people ask for the same information. The second one is that you interpret the information the same way. What we're looking for at this point is to know we're asking for the same information and to view how the United States has interpreted that, and then to compare with what we do and ask if we come to the same answer for the same reasons. When one has established both of those principles, then one can say it doesn't matter if you do the assessment because we do it exactly the same way.
It's a very simple statement to make, let's harmonize. It is an incredibly difficult thing to accomplish in reality. We will be attempting the same thing in the biotechnology area, which impinges on the pesticides area, for the ones that will come under CEPA, but it will not happen overnight no matter what we do.
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Neither the United States nor Canada can afford to give over their sovereignty totally and say we will automatically accept yours, but we are trying with the United States in Canada and with the European Union. Hopefully we'll then bring it all together at one point in the OECD such that you could get a generic assessment done by any one of the producing countries that would be acceptable in a third country.
Ms Kenney: I would add the point that, as Health Canada has described, under the agricultural legislation we are responsible for, the guidelines too have been developed in harmony with international bodies that have undertaken to write guidelines. For that reason, we see new guidelines coming out of Japan, for example, that are very similar to Canada's guidelines. Companies that have come to Canada and also to the U.S. and to Europe have found, as you have heard in this committee, that they often can use a single set of data to provide to each country.
Dr. Morrissey: I would just underline a point Des made that I think is quite important. Assuming that we harmonize the data requirements that a company must submit and assuming that we harmonize the scientific assessment of them - that is, what the degree of risk is and in what areas - that doesn't impose on any country a requirement that the decisions based on that assessment be the same.
For example, one country could decide that it's willing to accept a smaller degree of risk, a smaller degree of uncertainty, and put on more restrictive conditions. So while it's possible to standardize and keep the system simple and less costly, that doesn't impose an obligation to have the same decisions based on that same data in each country.
Mr. Steckle: Given that we're under a certain degree of assumption here and that we have two regimes, an American system and a Canadian system, in your view is it a reality that in the near term any one of these regimes is prepared to give up certain territory for us to arrive at a common conclusion? There are departments here that need to protect their turf. Given that there are obviously turf wars, are we prepared to put the public's interest ahead of the departmental interest?
That's a political question, but I think it's one of the questions that is constantly asked of the industry out there, which I represent.
Dr. Morrissey: In my reading it's a reasonable question, Mr. Chairman, and I take it in two parts, one internationally and one within the Government of Canada.
My sense is that it will be possible. I'm an optimist, but I think it will be possible to get common standards for data internationally and it will be possible to get common submissions internationally, simply because it's so costly to put together these submissions. They probably will be written, as most of the international standards are now, with a proviso for a country that has special requirements. For example, we're a northerly country so we may have special requirements in relation to cold. These would be allowed for, but the core data will be the same.
Within Canada, my sense is that it has already happened. For example, we have agreed within the departments around the table here as to what the definition of biotechnology is and what the definition of toxic is. We have also agreed as to what data is required to do these assessments. The words may change in the various departments, but we have agreed on the content. It's the same.
Mr. Steckle: My colleague Mr. Lincoln broached a subject this morning that I found rather interesting. As consumers there's one thing that is quite often paramount to us in making certain decisions. It's economics. We talked about residues and he very ably asked this question: if Canadians determine that we ought not to raise the level of residues in wines from 1.5% or 1%, whatever he had suggested, to 2% or 2.5%, how are we going to convince Canadians, even if it's to their detriment in the long term, not to buy European or Californian wines, which have a different standard?
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To give you an example, we Canadians had a disastrous corn crop in Ontario in 1993-1994. We imported a tremendous amount of corn from the United States, as we do from time to time. This product was treated with a chemical called Accent. Many of the acreages growing the crop we derived our source from were treated with that product. We can't use that product in Canada legally, yet we know it's brought in illegally from time to time. It does a tremendous job on weed control.
We have a similar product that we can use here. It has some of the same components. It's called Ultim. But there is something about that product that under certain climatic conditions causes corn to die, or to at least be stunted and fall behind. We would like to use Accent in Canada, but because of certain regulations we can't. We know it works, but farmers... And yet, we buy the corn from the United States. We buy corn flakes made from this corn. We don't question at all the fact that those kinds of chemicals were used in the production of that product.
It's the same with the wines. How are we ever going to solve that problem? We can put all kinds of restrictions on the way we do things here for what we believe is for the betterment of the health of Canadians, but if Canadians choose to buy a product from somewhere else...and yet we've destroyed an industry here -
The Chairman: Mr. Steckle, I hate to interrupt. I appreciate the importance of your question, but you are going into pesticide policies, and I wish to keep us on our biotechnological path.
Could we ask you for a short answer to Mr. Steckle's question from whoever wishes to tackle it?
Dr. Morrissey: Perhaps I'll make a quick comment, Mr. Chairman, and then my colleague Paul may wish to enlarge on it.
As a general comment that again goes back to first principles, the acts we all work under are safety, efficacy, fraud. As for efficacy, I don't think anybody argues that the product is efficacious. On the issue of safety, there are two subsets: one is safety to humans and one is safety to the environment. If I split the safety to humans again, there's safety, for example, to those who apply the products and to those who eat the products, the residues.
I can't give you the details on this particular pesticide. Let's take an example. You have a pesticide that is allowed in the United States because the risk associated with applicant exposure is acceptable to them. Assume for a moment that it's not allowed in Canada because the applicant exposure is not acceptable to us. Then it would be acceptable to import the product, because there's no risk associated with the product itself...it's the applying of the spray. That's simply one example of what the reasoning is between the United States and Canada where you get a different decision.
Thank you, Chairman.
Mr. Mayers: To add to that, imported products, like domestic products, have to meet the same requirements for residues. As noted by my colleague, even though it's grown in a different country with perhaps different requirements, the residues of that product would have to meet the legal requirements in Canada for it to be acceptable.
The Chairman: Thank you, Mr. Steckle.
Next is Madame Payne, then the chair, and then we'll have the second round.
Mrs. Payne (St. John's West): Thank you, Mr. Chairman.
Doctor, this question has been asked before of other people around this table. It has to do with products falling through the cracks.
At other meetings with main estimates and such things, we've been looking at and talking about cuts to budgets and cuts to personnel. I'm wondering whether in fact we have the necessary expertise and the facilities to be able to do what needs to be done, bearing in mind there are going to be a number of biotech products coming forward. Have we the necessary personnel and finances to make sure these products are subject to the regulation?
Dr. Morrissey: Thank you very much, Mr. Chairman.
The question, as I understand it, is about gaps in the current system in relation primarily to staff. Perhaps I could get a clarification, Mr. Chairman. Did the question also include legal gaps?
Mrs. Payne: Yes, you could include legal gaps, but I'm thinking more along the lines of the falling through the cracks for non-legal reasons, if you like, or for legal reasons.
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Dr. Morrissey: I have two quick comments, Mr. Chairman.
One is that legally there are really only three entities in this world: animal, vegetable and mineral. If we're speaking of living biotechnology there are really only two: animal and vegetable. About 100 years ago this country put together a set of acts to protect the public's interest in relation to safety risks in the animal and vegetable kingdoms. Part of animal is the human animal in Health; part is the rest of the animal kingdom and the vegetable domain in Agriculture and Agri-Food.
So those acts are there in very general terms. It has meant that as new technologies have come along, the basic enabling powers have been there. Sometimes clarification has been provided by amending the acts, but generally the powers are there for safety, efficacy and fraud. My sense is that it's hard to see where there would be gaps given that the animal and vegetable kingdoms are covered and safety, efficacy and fraud are covered, but there may be grounds for clarification.
The second point is whether we have the staff. If you ask a public servant, we never have enough staff. If there are more staff going, we would be happy to take them.
Having said that, my sense in speaking just for Agriculture and Agri-Food is that we probably do. The last big round of cuts in 1995 was not only a round of cuts; it was also a significant movement of personnel into areas considered to be high priority. Biotechnology has had staff move into it. For example, the group Margaret heads up in Agriculture and Agri-Food Canada is all people from other domains within Agriculture and Agri-Food Canada.
Mrs. Payne: I understand that, but are there products that are, as we were saying, slipping through the cracks?
Dr. Morrissey: For Agriculture and Agri-Food Canada, no. All of the products we are charged with regulating, assuming we had our regulations in place, are being covered at the same time. None of them have been released without having been assessed. In our area nothing is falling through the cracks.
Mrs. Payne: There seemed to be some indication from other witnesses around the table that this was happening.
Dr. Morrissey: Again, I can only speak for our area in Agriculture and Agri-Food - no.
Do you have any comments, Margaret?
Ms Kenney: Going back to the transcripts, I have read statements from time to time that a potato developed to be resistant to Colorado potato beetle was not fully assessed. I hope it has been clarified that this was certainly not the case. It had gone through at the level where small field trials were being carried out in Canada, a complete environmental assessment. As the work progressed, a complete human food safety assessment was carried out by Health Canada. Then before that particular potato was allowed to be grown commercially in Canada, a complete commercial environmental assessment was carried out. So if that's the example you're thinking of, the answer is no, it did not miss any steps.
Mrs. Payne: For the future of new products coming out, you were talking about your lack of personnel or finances.
Dr. Morrissey: My comment, Mr. Chairman, was that for example in the research group I'm involved in, while we lost roughly 900 to 1,000 people out of 3,000, we have moved 400 or 500 people across the country into other locations and sometimes into other jobs to cover priority areas. A priority area like biotech will be serviced even if it means moving staff and resources.
The Chairman: There are two questions from the chair and then we'll launch the second round.
One relates, Dr. Morrissey, to your reference a few times to safety to humans and safety to the environment. I wonder if you could give us an example of where you would draw a line between the two. It's a distinction I find difficult to accept, for the long term at least, but there may be cases you want to bring to our attention.
The basic question I would like to ask you is on the same wavelength as Mr. Knutson's as to where the line ought to be drawn in the business of biotechnology. In his submission to us,Dr. Leiss - and I'm reading now from his brief - says that human intervention in the case of new biotechnology, namely the transgenic entity, represents a qualitative transformation in that what becomes routine here is anomalous with respect to natural processes.
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This is a distinction I find extremely helpful and very appealing. It also seems to me that it is in this category we seem to have failed to convince the public that we are doing things the right way. The public confidence issue emerges in relation to transgenic.
If you were to redesign the system we have and provide advice to the government on how to do it better in order to regain the confidence of the public in relation to transgenic, where there seems to be a major difficulty...
The questions are: do you agree that the major difficulty is with transgenic? If you were to redesign the system in terms of both process and departmental responsibility, and in the light of the success so far, as you yourself have recognized, that was achieved when the responsibility for pesticides was given to Health Canada because of the link to human health, which you yourself recognize, how would you redesign the system?
Dr. Morrissey: There are two questions, as I understand it, one of which is on safety related to humans and the environment and the other on the organizational structure of biotechnology.
My sense, if I understand the question correctly, Mr. Chairman, on human safety and the environment is what would the role of Agriculture Canada be in relation to human safety. Again, subject to any advice that Margaret or others could give me, my sense is that if we had a crop, such as wheat, that was picking up heavy metals in the ground - for example, cadmium - we would not approve that crop because it's a threat to human health and safety.
For example, if we had a crop such as wheat in Ontario that had fungal toxins, as we had a few years back, we would not approve that crop for the food chain for reasons related to human health and safety. Take solanin, the green that's on potatoes. If we had potato varieties that had unacceptable levels of that - it's toxic to humans - we would not approve it.
In terms of environmental safety, Agriculture has been involved since the beginning, I guess, with stewardship of the soil, using soil in the larger sense. In the variety assessments that have been done since about 1923, when we did our ecological assessments, we would not have released into the environment varieties that would have been unacceptable for the reason, for example, of weediness.
On the question of the organizational structure of biotech, on whether or not the line should be drawn at transgenics in terms of an anomalous behaviour pattern in intervention in nature, again I defer to Paul's comments. The sense I would offer is that nature has in fact been diverging for a very long time but from a common base. That seems to be what we've learned in the last ten years or so, based on the genome mapping. Everybody has been surprised at how similar the genome bases are, even for structures that we humans would consider to be quite different.
So the fact that we are putting some of those genes back together again seems to be much less strange now than it would have been ten years ago. My sense is it's an evolving chapter and we don't know the final answer yet, but we know a lot more than we did ten years ago.
In terms again of the anomalous comment made by Bill Leiss, I think Bill's paper also said that it's a question of kind rather than of degree. He had a footnote that said while what he calls anomalous behaviour...his perception was that it wasn't an absolute in the sense that it never happened in nature. He said it may be a question of degree rather than of kind.
The last sub-portion of that question, as I understood it, was around gaining public confidence and the issue of organizational structure. If it were my decision I would not create a transgenic act, because we would have legislated based on a method that could be superseded by other methods at some time. That's the first reason.
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The second reason is the reason I gave a moment ago. Not only would we have not organized along any of the usual four headings, but also we would have organized by process and by a subset of process. Even within that structure we would have had duplicate acts. You would have had two acts related to biotechnology, one related to transgenics, and at least one related to others - two sets of regulations, two sets of guidelines, two agencies, and potentially two departments. So I think you would have had duplication.
The last comment is regaining the confidence of the public. From the surveys I've seen I wouldn't have used the term ``regaining the confidence of the public''. I would have used terms that I think would have fit the data I saw. The data I saw seemed to indicate that the public wanted the benefits of biotechnology but didn't want any risks or costs that might be associated with biotechnology, particularly when these risks got close to them personally.
I would have asked myself how with biotech, as with any of these other technologies, we can maximize...the risks, minimize the changes, and overcome fear of the unknown in a way that's acceptable to the public.
The last comment is on the public structure or the public, or which department and which sets of regulations affect which piece of biotechnology. My sense from the members of the public whom I've spoken to is they don't know, and I suspect may not even care, which department or which subset of the department does it. My sense is they're more concerned about ensuring that the product is safe and is efficacious.
Thank you, Mr. Chairman.
The Chairman: Thank you.
On the second round we'll have Mrs. Guay and Mr. Forseth.
Mr. Forseth (New Westminster - Burnaby): Given the large number of new biotechnology products that may well be produced in the future, how is Agriculture and Agri-Food Canada going to accommodate all these increasing demands for assessment and regulation of these products, in the terms of both funding and, I suppose, the expertise? Perhaps in that answer you can discuss the issue of fees and whether we are moving towards internalizations of costs so the price of products reflect perhaps the larger cost and how that relates to our international competitiveness of product.
So we're looking at the ability to respond, the costs of it, and how it relates to the end product.
Dr. Morrissey: My sense of new products coming into the market - this is just a personal perception - is that the new products are coming into the market to meet needs in Canada.
For example, we have a need in Canada to have a new variety of wheat every number of years that's resistant to new strains of the disease known as rust, which is coming up the Mississippi River. That's one need. That need has been met in the past through the traditional breeding of crops. If the need is met in future by transferring genes either within species or across species, it's the same need that has been met. It's a similar piece of work in assessing that new variety, and we would provide the resources to do it as we have provided the resources for the old technologies.
What I should add is that we have moved significant resources into biotech in the last few years, both in the regulatory group, which is now moving out as a special agency, and in the research group. For example, if you had done a survey of our research group 20 years ago, you would have found slim pickings in terms of knowledge on biotech, at least the transgenic biotech. If you did a survey now you might find that one in six of our scientists, one in each team, has expertise in molecular biology.
On our international competitiveness - I'll speak just for agricultural biotech - we are probably seen as being an advanced country in agricultural biotech. Some of the literature speaks of clusters of competence. The one cluster that I've seen written up in western Canada, and the only one, is around agricultural biotech.
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So my sense is that we probably don't have the resources or the competence the United States has, but in the agricultural domain we are probably up there amongst the more competent group of countries.
Mr. Forseth: I wanted to get to the other part, the price of the product itself, and how it represents an internalized cost of government administration rather than just saying it's a utility all taxpayers pay for. There are some fees involved. How are we doing at internalizing the costs in the product price?
Dr. Morrissey: If I understand the question correctly, you're asking how we recover the costs we've put into, for example, the variety of wheat. Is that the question?
Mr. Forseth: That's part of it, yes.
Dr. Morrissey: Second, what are the cost recovery levels? I'll make a quick comment on both and then ask Margaret to expand on them.
In terms of, for example, new varieties of wheat, the private sector in Canada really hasn't produced new varieties of wheat, because you as a grower, for example, could keep back some of this year's crop and use it for seed in future years, and a private company wouldn't recover their costs.
In that context the Crown has stepped in to fill a void left by the private sector. What we have been doing in recent years is charging for that wheat what the market will bear. The way we've determined what the market will bear is simply to put a variety up for tender. So royalties are recovered on that basis. The royalties don't cover the cost. If they did, the private sector would come in and replace us.
On the question of cost recovery for evaluation of biotech products, my information is that negotiations are under way with the interested parties. The target, I understand, is about 50%.
Ms Kenney: I really don't have much to add to that other than to say that every regulated commodity is undergoing this kind of negotiation with the industry. There have been several rounds of these negotiations.
So biotechnology is not being singled out. It's part of the whole process of cost recovery in the Department of Agriculture and Agri-Food.
The Chairman: Thank you, Mr. Forseth. Mr. Lincoln.
Mr. Lincoln: Dr. Morrissey, if I understood your remarks to Mr. Knutson about why we try to regulate the way we do now - in fact, I think I wrote down your words as you spoke them - the idea would be that every minister should be given the ministerial tools to deliver the particular ministry's products to the people. In other words, it's best that Agriculture be completely in charge of regulating products relating to agriculture, and industry, and forestry and so forth and so on. You even classed the environment that way. Environment would be in charge of products that have an environmental component.
I hope I misunderstood you. For me, it's almost as though time stood still, as though we're back to the 1950s or 1960s or something, that these ministries have vertical walls that separate them. They are little empires, little towers, that seem to have to delineate their responsibilities along vertical lines. I had thought we had evolved greatly from this theory. Certainly from the point of view of the environment and human health, or ecosystemic health, there was the whole idea of a holistic notion of government, of an ecosystemic notion of governance, where we look at the whole rather than little parts.
Maybe I didn't understand you properly, but if I did, you're saying each line ministry should be responsible for its own things to avoid duplication, because it knows its own field best. There is certainly merit in line ministries, and that will always be there. At the same time, I'd like to give you an example. It's one I started with this morning.
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We took the wine residue and are now bringing it up to 2.5%. We say fine, it's safe. The World Trade Organization has checked it out, OECD has checked it out, and it's all very safe. So we go along with that.
It seems to me what we don't do is that when that person drinks the wine, he or she also eats the grapes that have gone through pesticides, or eaten whatever else that day - beets or lettuce or apples, or tomatoes that have been subject to genetic improvement, or milk that soon will have BST in it if we go along with the Americans and license milk with hormone changes. We look at this wine product by itself and the health ministry says, okay, the WTO is right, and we'll go to 2.5%.
We look at the apples under the Minister of Agriculture and Agri-Food separately and we say, yes, the tolerance level, whatever it is, is okay. We look at the tomato that has been changed genetically and we say it's fine, it's great.
But what we don't look at, it seems to me, is that when I or my colleague across the way or any one of us accumulates the eating and the drinking of the wine - or the grapes, the apples, the tomatoes and milk with hormones - what happens then? What is the cumulative effect? Who tells me that is a safe level? What is that safe level? I don't know.
What is the synergetic result? I know we have discussed risk and cumulative risk. You take one gene and add to another. We know the properties of each. Cumulatively, the chances are not great that they will produce something completely new. But all I hear these days, with endocrine changes and reproductive changes, is that we are finding out now that chemicals that join together and have been assessed separately by one department here, one department there, or one country here, one country there, when they get together produce all kinds of crazy systems. Sperm count is down, the fish are changing sex, and the alligators... Every time you hear about it there are stories of horror, but each time we assessed each one of these products it was all right - and then suddenly there was a mixture of all these things and all hell got loose.
In your definition, Dr. Morrissey, of each department doing its own little thing - and you talk about ``my'' minister, ``your'' minister, ``his'' minister, ``that'' minister, ``my'' deputy minister, ``his'' deputy minister - who does the work amongst all of you to tell me, when I add up the wine and the apples and the BST milk and the other chemicals or the biogenetic products in my body at any one time, what is a safe level, and who tells me how that safe level is arrived at? Is it the Minister of Agriculture? Is it the Minister of Health? Is the Minister of the Environment? Is it the Minister of Industry? Which one, and which one should?
Dr. Morrissey: I'll attempt to answer the first three parts of the question, if that's acceptable, and leave the question of cumulative risk in the human health chain to Paul.
The first question, as I understood it, was on the tools to deliver the charge given to a given minister of a given department. My sense on that is that whether you organize the government's departments...indeed, whether you organize them at all, because an option is to have a single department, and in that case you don't have any coordination functions to worry about. Assuming for a moment that you do subdivide to simplify the task and create specialization, my sense is that it's reasonable to match both the accountability given to a minister and the authority given to that minister to deliver.
So it is in that context that I made the comment that the tools to deliver a mandate are a reasonable expectation of a minister charged with a mandate. It's simply the matching of authority with accountability.
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The second question is around the perception that there are vertical walls within departments. Again, here's my sense on that. Assuming for a moment that you don't have a single department in the Government of Canada, then you end up organizing along some basis like product, process, place or people. You could pick any one of those four.
Having picked one, you have a coordination function along the three other interfaces. My sense is that those four principles probably haven't changed much in a thousand years, and may not change much in the future. The second you start to divide and structure, you start to establish walls. Then you're left with a coordination function that, rightly or wrongly, has been given to Industry Canada in the case of science and technology.
On the issue of a holistic approach versus a reductionist approach, again I don't think anybody would argue that the holistic approach is the ideal approach. The only reason anybody has ever taken a reductionist approach is that we're simply not clever enough to understand all the variables in the world at the same time. So we divide government problems and scientific problems into digestible pieces.
My sense is that you're perfectly right, Mr. Lincoln - if I could address Mr. Lincoln through the chair - that it is a holistic issue, and that having taken a reductionist approach and broken it down into pieces, we have to put those pieces back together again and see how they affect the whole environment and the whole of society.
Perhaps I could stop there, Mr. Chairman, and ask Paul to address the last question.
Mr. Mayers: I'll attempt to address it by splitting it into two parts, one of which deals with the issue of the residues. Residues are considered on a consumption basis, rather than just an individual product basis; therefore, the use of a particular pesticide in a variety of products would constitute a determination of the human exposure to that product; therefore, the acceptable residue for that product would be determined on that complete exposure basis, and then used to determine an appropriate residue in an individual product. That is as simple an approach as I can explain in terms of residues.
In the broader context that you raised regarding the issue of residues in combination with products of biotechnology and other issues, of course, as you very rightly note, all may potentially impact in terms of diet.
As for its impact on humans, we do recognize that consideration. In fact, the approach we take for the assessment of products of biotechnology applies that thinking by using the approach of substantial equivalents in demonstrating that a product of biotechnology is similar or equivalent to the most traditional product for which it can be considered a comparator. By doing that, since the traditional product has been in the diet for a long time and we therefore have some understanding of how that product impacts in the diet by demonstrating that the novel product is in fact equivalent to the existing product, we can address that potential you very rightly noted.
Thank you.
Mr. Lincoln: Can I ask one more question, Dr. Morrissey?
You mentioned the idea of a single department. That's as far from my mind as from yours. That would be the ultimate folly, of course. We all recognize that it can't be.
At the same time, surely there are departments that are horizontal in their mission. They have far more of a public-good mission, a more neutral mission than others. For example, the finance department acts for all ministries or departments on a cross-cutting basis, as does the Department of Health, as well as, I think the Department of the Environment. These are not line ministries in terms of those that have specific line missions. Surely there are some cross-cutting ministries.
You have agreed that if you had to start again you probably would have two statutes for biotechnology. As for who should be empowered or given the mission to look after this in the way of ministries, you say you don't know, because somehow the public doesn't know and you think it doesn't even care.
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Well, certainly that's not my impression of what the public feels. I think the public cares very much. I think what the public doesn't know is how government runs. Sometimes we don't know here. But I think the public knows that it doesn't want any conflict of interest or such situations, call it what you will. It's what Dr. Leiss referred to as the promoter being the regulator. I think if you asked the public, it would say it would rather avoid this.
I think the public would also say that it wants a more neutral regulator, some department, whatever that may be, that has no axe to grind. That was the clear message that came through under the pesticides review. They felt that the Department of Health was much more cross-cutting, essentially for the public good, and not a promoter in that case, so it would be a better regulator.
Don't you agree, Dr. Morrissey, that by their nature and because of their mission that the ministries of environment and health represent much more of those cross-cutting, horizontal, public-good ministries and are much more neutral to administer the two theoretical acts that you would have put together?
Dr. Morrissey: Thank you, Mr. Chairman. Again, I'll try to answer those questions in the order in which they were raised. If I miss one, I'd be grateful if you'd take me to task and remind me.
The first question was about horizontal or cross-cutting departments. Again, the question is perfectly correct, as there are horizontal or cross-cutting departments.
There are four principal ways in which you can organize. One of them is a process-type department. You could have, as Australia has, a department of science and technology. In this country, we've decided that science is a tool. We've given it to various departments that need to use that tool. But it's certainly possible to do this.
We could have had biotechnology laboratories. This is another example. This was requested by several parties a few years back. What has evolved is what we suspected would evolve: biotechnology has become a tool used in all of the biology departments that I'm involved in. If we had put all of our biotechnologists in one department, we would have had to use them.
What it really raises is the issue of whether you manage by means or by ends. Biotechnology in this case is a means. Personally I would prefer to manage by ends, because in that way I at least include the means that are involved and I know where I'm trying to go.
In terms of the two statutes, I wasn't aware I had mentioned two statutes. My sense is that if I were designing a biotechnology regulatory system, I would have designed it around the animal kingdom and the plant kingdom. I would have designed it around criteria of safety, efficacy and fraud, and I would have placed those responsibilities in the areas where the greatest expertise rests.
In terms of whether the ministry of environment or the ministry of health are the best qualified in the broadest sense, which is the sense of public good, to handle those mandates, my sense is that certainly the Minister of Health is in the best position of expertise and, in my personal perception, public credibility to handle issues of public health.
In relation to issues of the environment, my sense is that the environment is so vast that it's impossible to put everything related to the environment into one organization. Back at the time of the Glassco commission in the 1960s, when Environment Canada was set up, the concept was to create a safety net department, if I can use that term, that would fill any gaps in the environment that weren't already covered by other departments.
My sense in looking at the environment is that everything we do and breathe is environment. In consequence, you're back to the issue of a holistic approach to problem solving. It's simply so large, it's just about everything. You would probably have to take all of the existing departments, put them into Environment Canada, then redivide them in some other way.
Thank you, Mr. Chairman.
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Mr. Knutson: Again, I want to follow along Mr. Lincoln's theme and make a couple of points. I'll try to be quick and to the point.
When we look at this issue of the wine, I think Mr. Mayers said that at the end of the day we have to justify it on science as to whether we're going to keep out wine that increases the residue from, say, 0.5% to 2.5%.
My observation would be that at the end of the day science only takes us so far, and then we have to make a subjective decision based on values. It may well be that increasing the residue in wine increases the likelihood of one person in 10,000 getting sick and that it increases the likelihood of that one person who gets sick having a certain risk such that they die.
Somebody has to decide whether that's an acceptable risk. Scientists can lay out what the choices are, but at the end of the day they can't make those decisions. You can't make it on objective criteria unless anybody in this room knows the economic value of human life. I've never heard anybody say what it's worth. I don't know what Paul's life is worth, but it's worth a lot. So I'm taking that as a starting point.
Then, Dr. Morrissey, you said Agriculture Canada wouldn't approve something if it was a threat to the environment or human health. I applaud you for that. But the point I was trying to make earlier is that ``threat'' is an imprecise term. We can all agree that at a certain point something's a threat and it shouldn't be approved. But then as you go down a continuum of saying that this is less of a threat, that is less of a threat, here comes the economic advantage of introducing it and these are the gains as the risk decreases, where do we draw the line?
A farmer might draw the line differently than an environmentalist might, or a minister of agriculture might draw the line differently than a minister of health might. That's notwithstanding that all of these people get elected to serve the public good. I accept that as a given. There may even be acts that say in law that they have to serve the public good.
The point I was trying to make earlier, which I think Dr. Leiss brought up, is this. Say we go back to the fundamentals of running an organization. You have to have a hierarchy of purpose. The primary purpose of the Department of Agriculture is different from that of the Department of Health. It's a different purpose. In the end, that could affect the way decisions get made, not the big ones but some very fine decisions that could be important. I think there's a prima facie argument such that departments with an economic agenda shouldn't be making decisions if we say health and environmental concerns are paramount.
I'm just asking, first, do you accept that there is a prima facie argument? Then maybe I could just get a response to my comments.
Dr. Morrissey: Thank you, Mr. Chairman. Again, there are several sub-questions. I'll try to answer them in the order in which they were raised.
The first one is the threat to the environment and the uncertainty around that threat. My sense is that the point is perfectly well taken. It's because of this that the legislation I'm familiar with is based on suspicion rather than absolute knowledge. It's based on threat rather than ex post knowledge.
As for the issue of a farmer making one kind of decision and an environmentalist making another, my sense in dealing with farmers is that they are environmentalists. They bought their property for sustainable development, meaning they don't want to go through the Dirty Thirties again when the west was turned into a dust bowl partly because of technology and with a little help from nature. But my sense is that the term ``stewardship of the soil'', which has been around for a very long time, simply indicates that farmers want to pass their farms on to the next generation and perhaps to the generation after that.
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Mr. Knutson: Perhaps I could interject for a second. But if that were true, we wouldn't have a topsoil problem.
Dr. Morrissey: No, I don't think that's the case. For example, before the dust bowl in the 1930s, it's reasonable to assume that farmers didn't want to have a dust bowl, they didn't want to lose their properties, and they didn't know that the moldboard plow... I submit that if we had been in the 1930s, none of us could have predicted that with a little help from nature, the moldboard plow would have given us a dust bowl in western Canada. And when we got the dust bowl, we in Agriculture Canada recognized that harm had been done. We created a group, the Prairie Farm Rehabilitation Administration, about 1,000 people who have been working - and are still out there - ever since the dust bowl to rehabilitate, to put the sustainable side of sustainable development back in place.
For example, the group I work with, the research group in Agriculture Canada, developed a lot of the technologies that put the sustainability back into western Canada, which overcame the dust bowl. Approximately 80% of the resources I'm involved in are involved in the sustainable side of the sustainability development equation, simply because nothing is permanent in biology. You really can lose the sustainable side of it very quickly.
I gave the example of wheat. In the 1920s we came up with a variety of wheat that was resistant to rust. It only lasted for a few years. Nature starts to adjust. It's not sustainable.
Mr. Knutson: On that point, if I can, the farmer who has to make a cashflow at the end of the year - or he loses his farm - can't take a long-term environmental stewardship into account the same way as someone else who's not under cashflow pressures. Once you introduce the commercial imperative into the equation, you can bias decision-making into short-term gain at long-term expense.
That's my general point, saying that a farmer might make a different decision than an environmentalist might.
Dr. Morrissey: Again, in dealing with farmers over the last number of years - take the western Canada example again - I have a sense that farmers want sustainable tillage, for example. Over the last number of years we have been under significant pressure to move resources into sustainable tillage so that they can get both an economic return and a sustainable return.
Mr. Chairman, the question is quite correct, in the sense that there are cross-pressures between sustainability and development, but speaking to farmers, I have a sense that they want both. They want to be in the business for the long term.
I would like to make a last comment on the mandate of the Department of Agriculture. In the context of the latter part of the question on Health Canada, if you read Agriculture documents you'll find comments like those referring to a safe, reliable food supply. My sense is that if you look at the mandate of Health Canada, you'll see that they're not only concerned with a safe, sustainable food supply, as we are, but as an umbrella organization they are concerned with many other aspects of human safety.
So I don't see it as a conflict. I see us both working in the same direction. But food is only one part of the human health and safety equation.
The Chairman: Mr. Steckle, do you have another question?
Dr. Morrissey, I have two brief questions. In reply to Mr. Lincoln, you touched upon the Australian approach to science and the Canadian approach. Is my impression correct that in your assessment of our approach to science, we are on the wrong track?
Dr. Morrissey: No, Mr. Chairman. If you were to ask me for a black-and-white answer, I would say the Australians are on the wrong track, because I think they have treated science as if it were an end in itself.
My understanding of science is that it's a means to an end. It's a means of solving a problem, or it's a means of exploring an opportunity. If I were designing a system in Australia, I would give science to those departments that have problems to be solved and opportunities to be explored.
As it now stands in Australia, if a line minister in mining, agriculture or health needs a piece of research done, that tool isn't available to them. They have to go and ask somebody else to provide it.
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The Chairman: Would that premise lead you to dismantle the National Research Council?
Dr. Morrissey: No, I think Canada has managed its affairs a little differently. Canada has a National Research Council. It looks after parts of research not covered by the other line departments, but it hasn't denied line departments the scientific tools they need to solve their own problems or explore their own opportunities.
The Chairman: This is the next question that comes up. All of you this morning agreed with Mr. Lincoln that there is a necessity for a holistic approach; that the accumulation of residues, as identified in separate ways, can, however, lead to the conclusion we made, with which you agreed. At the present time, which agency, if any, is developing the holistic approach in biotechnology?
Dr. Morrissey: My sense of the question is that the ultimate desirable goal is to have a holistic approach to problem-solving. Given the limitations of intelligence and understanding each of us has, it is impossible to go directly to a holistic approach. We will still be forced to pass by reducing the problem to its component parts, understanding them, and then reassembling the whole.
I don't think we can avoid that intermediate step of reducing the problem to manageable and digestible pieces.
The Chairman: When you reduce the problem, who does the reassembling?
Dr. Morrissey: Do you mean reassembling in terms of the environment?
The Chairman: Yes, or the impacts on environment, health, and the like.
Dr. Morrissey: I would have suggested that it's those people who have the expertise to do it.
If, for example, the impact is on agricultural soils and agricultural waters, I would have said it's in Agriculture. If the impact has to do with the cumulative question that was asked of Mr. Mayers a moment ago, about cumulative effects on human health and safety, I would have said it's the Department of Health. And if the issue was on cumulative effects in relation to the biology of fish, the expertise probably rests in the Department of Fisheries.
The Chairman: Who then does the cumulative?
Dr. Morrissey: Again, depending on the domain we're speaking of - human health, health, agriculture, and areas that are areas of gaps - Environment Canada.
The Chairman: So are you satisfied that this cumulative overview is under scrutiny?
Dr. Morrissey: I'm satisfied, Mr. Chairman, based on the evidence of the last hundred years, applying the existing acts and the existing agencies to new substances and their assessment. New substances were primarily biological entities that came in from other countries. But when we think that 80% of the crops and 80% of the pests in this country all came from other countries, a hundred years of empirical evidence is reasonable evidence.
The Chairman: Is there any other comment?
Mr. Mayers, are you satisfied that in Health Canada you do evaluate the cumulative effect of separate findings?
Mr. Mayers: In terms of the area I'm most familiar with, food safety, yes, I do. In the broader context, I believe the health protection branch very much gives broad consideration to cumulative effects. So, yes, I do believe that the department does recognize the potential impacts of cumulative effects and gives consideration to them in evaluations.
The Chairman: Dr. Mahon, do you have any comment?
Dr. Mahon: Thank you, Mr. Chairman, I have two minor comments.
I agree with Dr. Morrissey, in that I don't think either our science or our competence exists right now to reassemble in the way we have described, to reassemble in detail, a holistic approach to an assessment. However, we have moved a long way away from the pinpoints of risk assessment, certainly under CEPA and in other departments, in the environmental assessment, as we move to an ecosystem approach rather than a single-assessment approach, where we take into account entire systems. We are coming closer, shall we say, to a holistic approach than we are to the specific toxicity approach. It will, however, I believe, take time for this approach to develop.
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The Chairman: What is missing in order to have this approach in place?
Dr. Mahon: I can give a personal opinion. I'm not sure if I can give anything other than that.
My belief is that the science is there but has not been integrated fully into a holistic approach, where one can take all of the inputs in their appropriate weighting and put them back together again. The individual pieces are probably there, but to get it completely integrated into our system takes more science than we have currently. Also, I believe it takes time for a new approach to be integrated into any bureaucracy, whether it be an academic bureaucracy or a government bureaucracy.
Dr. Morrissey: I have a comment on the systems approach or the holistic approach. Within Agriculture and Agri-Food Canada and indeed within sister departments around town there has been an effort for years to create a single food agency. My sense of why it is working at the present time, why a decision has been made to go with one, is that the whole is being moved into an arm's length agency at the same time. Not just food inspection but the whole pyramid that leads to food inspection, meaning animal health, plant health and food safety, are all being moved into a single agency in Agriculture. The whole system is moving out there.
The reason I think that's important in the sense of a holistic approach is, to take the question I raised earlier of cadmium in wheat, for example, or salmonella in poultry - a topical issue - if that problem is identified at the food level and you have only a food inspection agency, then you have to cross agency boundaries to get into the farm or get out to the soils and correct the basic problem. By moving all of the pyramid of food development and food inspection, including biotechnology, out into a single agency, a systems or holistic approach is taken, as far as is possible, within those four corners.
The Chairman: Thank you very much. It is time to adjourn.
This brings to an end the series of pre-summer meetings. I'm sure my colleagues would want to convey to you our appreciation for your answers, comments, opinions and objective views.
This committee has no authority to ask you for anything except to appear before us and answer questions. However, since the summer is long - or very short, depending from which perspective you look at it - this committee would certainly appreciate it very much if you would let us have, if there is one, a possible alternative design to the way we handle biotechnology at the present time.
This morning you have put forward a number of interesting thoughts that partially deal with alternative designs as desirable, possible ways of approaching biotechnology and regulating it. But the mosaic is incomplete. It would be helpful if we were able to look at something in the light of your experience rather than doing it on our own.
I'm just extending an invitation to any one of you who has ideas to advance on this complex subject. In light of the fact that the summer is very long, there is an opportunity here to advance something that ultimately would be to the advantage of the public interest.
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I don't know whether I have expressed myself clearly, but if I haven't, please let me know. I'm sure my colleagues on this committee will appreciate your input as much as I do.
So, with that, I wish a happy summer to all of you. Again, our thanks.
[Translation]
Mr. Morrissey: Thank you, Mr. Chairman.
[English]
The Chairman: This meeting is adjourned.