[Recorded by Electronic Apparatus]
Wednesday, June 12, 1996
.1536 
[Translation]
The Chairman: Good morning.
[English]
Welcome, all. We now have a quorum and can start an in-depth examination of Health Canada's modus operandi in biotechnology. I understand that the delegation from Health Canada is headed by Dr. Bailey.
Dr. Bailey, please introduce your people or whoever is at the table who wishes to be introduced, and then start your presentation.
Dr. Keith Bailey (Director, Bureau of Biologics and Radiopharmaceuticals, Health Protection Branch, Department of Health): Thank you, Mr. Chairman. I am the director of the bureau of biologics in the health protection branch at Health Canada. With me are two colleagues who I believe will be able to assist the committee at length as we proceed. Paul Mayers is from the food directorate and Wendy Sexsmith is from the Pest Management Regulatory Agency. She will also be making a presentation.
Mr. Chairman, I shall start my presentation and then Ms Sexsmith will follow.
I would like to describe some of the acts and regulations on biotechnology that are within Health Canada's mandate and purview. In particular, I shall start with those that are administered by the health protection branch, and my colleague from the Pest Management Regulatory Agency will cover the acts and regs from which it operates.
You will recollect hearing from my colleague Dr. George Paterson last week on food labelling, and I outlined Health Canada's activities in a broad sense last month.
Through the health protection branch and the Pest Management Regulatory Agency, the department fulfils it's mission, which is to help the people of Canada maintain and improve their health by defining, assessing and managing risks to health associated with, among other things, the food supply; the manufacture, sale and use of drugs; the environment, including the workplace; consumer products, which include cosmetics; and medical devices.
Several times around this table we have heard the definition of biotechnology: the application of science and engineering in the direct or indirect use of living organisms, in their natural or modified forms, to produce new products. It is regarded as enabling technology. Some products produced by biotechnology are categorized as novel foods, food additives, drugs, cosmetics and medical devices, and as such are regulated by Health Canada under the Food and Drugs Act and regulations. Other legislation that covers biotech products include the Department of National Health and Welfare Act, for example, with respect to the importation of human pathogens, the Hazardous Products Act and the Pest Control Products Act.
The regulatory principles under which we operate - I indicated these on May 16 - reflect the following needs: first, to maintain Canada's high standards for the protection of the health of workers, the general public and the environment; second, the use of existing legislation and regulatory institutions - which are familiar to the industry, which is regulated by Health Canada - to clarify responsibilities and avoid duplication; and third, to develop clear guidelines, through evaluating biotechnology products, that are in harmony with our national priorities and international standards.
We wish to provide for a sound scientific base on which to assess risk and evaluate the products, to ensure that the development and enforcement of Canadian biotechnology regulations are open and include consultations, and contribute to the prosperity and well-being of Canadians by fostering a favourable climate for the investment, development, and adoption of sustainable Canadian biotechnology products and processes.
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This part of the branch's regulatory approach -
The Chairman: I'm sorry to interrupt, Dr. Bailey, but it's difficult for the members of this committee to follow you without a copy of the text you are reading from.
Dr. Bailey: Mr. Chairman, I would be happy to provide a text at the end of this presentation, but it would certainly need some skilful translation from my writing. I regret that I was unable to produce one today.
I'm not sure exactly how much time I have either, Mr. Chairman.
The Chairman: You have ten to fifteen minutes, and then I suppose there will be another speaker who will follow you, as you mentioned. This will provide members of the committee time for questioning.
Dr. Bailey: In that case I will certainly not try to speak so rapidly as to provide difficulty for the translators. At the same time I want -
The Chairman: Not only the translators but also the over-fatigue of the parliamentarians....
Dr. Bailey: I understand.
The branch's regulatory approach is to shift to a more strategic regulatory focus and target those areas that impact most on health and safety, such as the development of novel food regulations; to initiate regulatory changes; to better relate the degree of regulatory control to the level of the risk or the nature of the hazard, such as the development of risk-base classification for drugs and medical devices; and, as appropriate, to harmonize our regulatory requirements with those of other regulatory regimes around the world.
In particular, of course, in Canada we look to those of the Food and Drug Administration. We also interact with those of the European agencies, particularly in drugs, with respect to the Medicines Control Agency of the United Kingdom, through tripartite arrangements. We also interact with the OECD, the Organization for Economic Cooperation and Development, and the International Conference on Harmonization.
I would now like to turn to Food and Drugs Act. The act and its regulations provide the legal instrument for the sale of food and food additives, human and veterinarian drugs, medical devices, and cosmetics. The thrust is toward the safety and quality of the products and toward counteracting misrepresentation and fraud. In the case of drugs and devices, the thrust is on the efficacy or risk-benefit ratios - the standards on behalf of consumer interests.
Turning to food, Health Canada has primary responsibility for ensuring safe and nutritious food. The regulations offer a number of mechanisms. For example, pre-market approval is required for food additives and infant formulae. Post-market monitoring is undertaken for all products through inspection and, where necessary, through any kinds of action such as seizure, forfeiture, or prosecution.
In recent years the food industry has been responding to consumer interests by introducing a variety of novel foods that were not previously available in Canada, including products of biotechnology. Novel food regulations were published in the Canada Gazette in August 1995 and publication in part II is scheduled for later this year. The details of these regulations can be made available or you could ask more about them later if you are interested. I'll skip this part out.
During the period of approval, which is necessary before they can enter the marketplace, the manufacturer has to have an assessment satisfactorily completed. To assist the industry in collecting required information Health Canada developed guidelines for the safety assessment of novel foods.
Turning to drugs, current regulations require Health Canada's pre-market approval of a drug with respect to safety, efficacy and quality. They provide the post-market monitoring. In 1982, schedule D, which deals with biologics, which would include all the biotherapeutic...all the biotech products, was amended to include drugs obtained from recombinant DNA procedures. It includes such things as monoclonal antibodies, which are defined as biological drugs.
For biologics, there are additional requirements beyond those of other new drugs for the licensing of the manufacturer's premises and also to provide for lot-by-lot releases. The process and conditions of manufacture must be suitable to ensure that the product will not be unsafe for use.
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As for foods, Health Canada has developed a number of guidelines to assist industry in complying with the regulations. For example, three were introduced in 1990 respecting recombinant DNA technology, the use of continuous cell lines, and the manufacture and testing of monoclonal antibodies and their conjugates. These could be regarded as the new type of biotech products. The more classical type of biotech product, blood itself, in fact received new guidelines in 1992 respecting its manufacture.
The review of veterinary drugs for use in veterinary medicine is the same regardless of whether it is produced in a traditional manner or by biological or biotech means.
The drugs directorate engagement with ICH, the International Conference on Harmonization, has engaged us in a lot of work on biotechnology standards and processes and product standards. Apart from the United States and Japan, Canada is the only country involved directly with the ICH process.
The ICH involves the European Community as a whole, the Food and Drug Administration of the United States, the Japanese regulatory authority, and the three corresponding manufacturing authorities of those three areas. Canada is an observer on the ICH process and in fact provides expert witnesses and participates in the committee work, particularly respecting biotechnology drugs.
We have also undertaken joint reviews with such authorities as the Food and Drug Administration, for example, in the case of the biotechnology drug, Pulmozyne.
On medical devices, the regulations apply to those devices considered to be biotechnology products, such as diagnostic kits. They must comply with a particular schedule that requires that any kit containing biological materials that are capable of transmitting a disease must carry an appropriate warning label. There is a clearly defined and familiar system, including cost recovery and performance standards, expounded through concise regulations and up-to-date guidelines, which are understood to provide industry with an assurance of what to expect and a quality, science-based evaluation needed to develop corporate innovation and investment in the Canadian economy.
Health Canada is developing regulations to provide for the environmental assessment of biotech products regulated under the Food and Drugs Act to provide a single-window approach for regulating foods, drugs and medical devices and cosmetics from an environmental and a health and safety perspective. This approach is fully consistent with the principles set out in the 1993 biotechnology regulatory framework and the government's 1994 jobs and growth agenda.
In developing these regulations, we reviewed situations with our major trading partners and plan to adapt or adopt the principles in the context of international harmonization, as is appropriate. We will be consulting with stakeholders on the proposed regulations in the coming months and propose to publish the regulations in the Canada Gazette next year.
Very briefly, just to look at the Department of National Health and Welfare Act, which is to be replaced by the Department of Health Act that received royal assent on May 29, human pathogens importation regulations came into effect in 1994 to protect the Canadian public from the inadvertent transmission of communicable diseases from imported human pathogens. The laboratory bio-safety guidelines provide an operational framework for the administration and interpretation of regulations and for safe work and operations.
The Hazardous Products Act deals with biotech products, which are biohazardous infectious materials subject to labelling and material safety data sheets, which are requirements of the controlled products regulations.
Environment Canada and Health Canada have joint responsibility for the administration of the Canadian Environmental Protection Act. Health Canada has responsibility for assessing and managing the risks to human health associated with use substances, including the biotech products.
This, Mr. Chairman, summarizes the acts and regulations of the health protection branch that particularly govern biotech products. As mentioned, we are addressing emerging needs and are targeting the high-priority areas, such as the novel foods regulations and the environmental assessment regulations. We're developing a risk-based approach.
The new drug licensing framework is presently the subject of stakeholder consultations, and risk-categorized, medical device regulations are scheduled for next year. We are actively participating in international fora, such as the OECD, as I mentioned, and the International Conference on Harmonization. Thus, we are not acting in isolation but are fully aware of steps being taken in other countries.
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I believe my colleague from the Pest Management Regulatory Agency would value an opportunity to address the committee.
Thank you, Mr. Chairman.
Ms Wendy Sexsmith (Director, Alternatives Division, Pest Management Regulatory Agency, Department of Health): If it's all right with you, Mr. Chairman, I'll present a general overview of the PMRA and some of its new thrusts. Then my colleague Janet Taylor will zero in on the authority of the Pest Control Products Act and some of the processes, focusing on the biotechnology issues.
As many of you around the table know, as of April 1995, and as a result of government's decision in December 1995, the Pest Management Regulatory Agency was formed as the result of a consolidation of resources, people and expertise from Environment Canada, Agriculture and Agri-Food Canada, Natural Resources Canada and Health Canada. All of these resources, people and expertise were consolidated under Health Canada, with the Minister of Health having the administrative responsibility for the statute that deals with pest control products, or pesticides, in Canada, the Pest Control Products Act.
Essentially, the goals of this new PMRA and the renewed system for regulating pest control products in Canada are to protect human health and the environment by minimizing risks and to support the integration of pest management with the broader goals of sustainability.
The agency has made a concrete commitment to sustainability. To fulfil that commitment, a specific division within the Pest Management Regulatory Agency, under Health Canada, is dedicated to fulfilling these goals of the PMRA with respect to sustainability.
Essentially, there are three main areas. We're looking to integrate PMRA functions with sustainability, to facilitate access to products and new technology that fit under that umbrella of sustainability, and to find ways to contribute to the development and use of sustainable pest management systems.
The reason I mention this relates to the fact that both the PMRA and most OECD countries recognize that products such as microbials, including products resulting from biotechnology, can play an important part in being alternatives to traditional chemical pesticides. As well, they may play very important roles in ecologically based pest management systems, or more sustainable systems.
Of course, the role of microbials, or biological pesticides, including transgenics, or genetically modified organisms, in sustainable pest management does not mean these products do not need to be adequately regulated. Janet will talk to that a little bit later.
In addition, just to highlight some side issues that I think you previously expressed interest in, in the government's commitment to set up the PMRA government also committed to ensure public participation in decision-making, to develop a national pesticide use database, and to implement cost recovery.
That's all I'm going to say here. Janet Taylor will continue.
Ms Janet Taylor (Director, Product Sustainability and Coordination Division, Pest Management Regulatory Agency, Department of Health): Thank you, Mr. Chairman.
The Pest Control Products Act captures all pest control products. The definition is very broad. It includes microbial pesticides, both naturally occurring and transgenic, or genetically engineered. It regulates the manufacture, import, export, sale and use. All products must be registered prior to use and sale, and the health and environmental assessments are paramount. Section 9 of the regulations specifies general data requirements, and specific detailed requirements for specific types of products are elaborated in guidelines.
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We currently have microbial guidelines. This is a science-based document. It was developed through consultation with stakeholders and with international experts. The guidelines incorporate specific requirements for the transgenics. Within the agency, we have many years of experience in the regulation of naturally occurring microbial products, for control of pests in forestry and in food crops and for control of biting flies. The agency has developed a large body of data and expertise and has built on this expertise to develop special requirements for the transgenic organisms.
Currently we have about 30 products registered based on micro-organisms or microbial pesticides. These are all naturally occurring. We have to date had only one based on a transgenic. It was not a living organism, and that product was withdrawn by the company.
So the key points in summary are that the Pest Control Products Act captures all pest control products; the health and environmental assessment is paramount; for transgenics, there are specific science-based data requirements; the PCP Act includes assessment of process, which for transgenics would be the construction of the organism plus the method of manufacture and quality control; and the agency is committed to incorporating sustainability into decision-making.
Thank you, Mr. Chairman.
The Chairman: Thank you. Who's next?
Dr. Bailey: That is the presentation, Mr. Chairman, from Health Canada.
The Chairman: Then we can start.
[Translation]
Mr. Asselin, would you like to begin?
Mr. Asselin (Charlevoix): The first principle of the regulatory framework for the January 1993 biotechnology legislation is to ensure high standards in the fields of environmental protection and human health in this country.
The second principle is that existing legislation and institutions should be respected, jurisdictions clearly set out and overlap avoided.
It is difficult to see how we can deal with biotechnology issues seriously when there are seven departments and countless officials to implement the legislation and regulations. How can they help but step on each others toes?
I am convinced that there are implementation and overlap problems and also difficulties when it comes to understanding and enforcing the law.
From Health Canada's point of view are the objectives and purpose of the 1993 framework being attained given the current division of assessment and regulatory responsibilities between the departments of Health, Agriculture and AgriFood, Environment, and Fisheries and Oceans?
[English]
Dr. Bailey: Mr. Chairman, thank you. With respect to these very direct, and I may say probing, questions on efficiency of the regime as currently proposed and as exists today, it has been felt - certainly I will speak directly for the drug side, with which I am quite intimately familiar - that the manufacturer has come to well understand how Health Canada will deal with products. The industry tends to be a product-based industry. It's not that one is a biotechnology process manufacturer; it's rather that one is a vaccine manufacturer, a drug maker, and so forth.
Biotechnology happens to be the means by which this particular product is made. So a classical biological product, such as some of the classical vaccines - polio vaccines, for example - has been made under the strictest regulatory control, which has been run by Health Canada and is well understood by that industry. Similarly, the more modern biotechnology product - be it a recombinant product, which is probably foremost in people's minds - has come to Health Canada for the assessment of its safety, efficacy and the quality by which it is manufactured, and a strict standard has been set there. So I believe the manufacturers of products do understand that there is a window to which they would go to have their proposals and submissions evaluated, and a fully scientific evaluation done.
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As I mentioned in the presentation, it is proposed that the environmental assessment would also be done through this same window, so the new biotech product would come into Health Canada, which would be doing the human health assessment. The efficiency would be gained through having the same regulatory group being enabled to conduct the health risk assessment from the environmental side also.
It is true that many departments are involved in this, but I think it's a natural outcome of new technology or new procedures being put in place. It has suddenly occurred to me that computers have come into almost every department, and some departments are perhaps using one computer system and some departments are perhaps using another computer system. But certainly there would be no proposal that all computer systems within every department necessarily had to be evaluated centrally.
There's a technology here that is very useful. I think biotech in the manufacturing field has gone much the same way. It has enabled mining and forestry to become more efficient. It has enabled new food stuffs to be produced, which are reviewed within Health Canada through well-known procedures. Perhaps my colleagues would wish to speak to the agricultural side or the pest control side.
Ms Sexsmith: If I could use the consolidation of the PMRA as an example, until last year, because of the way pesticides were regulated, Agriculture Canada had responsibility for administration of the act, but Health, Environment and NRCan, to some extent, were all involved in the process. What we have now is a consolidation and an absolute single window for pest control products. I think it's very clear to the manufacturers that the single window is the Pest Management Regulatory Agency under Health Canada.
In that sense, I don't think there is duplication or overlap. The regulation of those products is captured under the Pest Control Products Act, be they traditional chemical products, as we call them, naturally occurring organisms, or organisms as a result of transgenic-type biotechnology.
[Translation]
Mr. Asselin: Many witnesses have told us that some biotechnological products have fallen through the cracks and are not regulated and may never be regulated. Does the department know if there are currently any such products that are not regulated or potential products might not be covered by the current regulations because of shortcomings in the regulatory framework?
[English]
Dr. Bailey: Yes, I believe Health Canada does believe there are currently areas where products are not being adequately regulated. Some examples do spring to mind. One hears of cloud seeding experiments using modern biotechnology products. It is certainly our belief that until the new substances regulations come into effect, that is likely to continue. It does need to be addressed.
[Translation]
Mr. Asselin: It is disturbing if there are the same regulatory gaps in the food sector and more particularly in the prescription drug sector. MPs have cause for concern if Health Canada is not bringing in enough regulations in the food sector since this could be harmful to people's health.
[English]
Dr. Bailey: My colleague will address the food products issue.
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Mr. Paul Mayers (Acting Chief, Evaluation Division, Bureau of Microbial Hazards, Department of Health): In terms of food, Health Canada has proposed novel food regulations. All novel foods, which would include products of biotechnology but not products of biotechnology exclusively, would require notification to the health protection branch prior to their marketing. That pre-market notification would permit the branch to conduct a comprehensive safety assessment prior to these products reaching Canadian consumers. Therefore, in terms of food, we do not believe that any gaps exist to permit food products of the technology to go through the process without pre-market notification.
[Translation]
The Chairman: Thank you.
Mr. Asselin: You know, nowadays, there are all sorts of charlatans out there calling themselves natural health or natural food therapists. Is natural medicine and natural medication regulated by Health Canada?
[English]
Dr. Bailey: As far as it is possible, these are controlled. There are certain practical limitations to what can be done, but when there are instances of fraud, as you are alluding to, Health Canada does have mechanisms and can take action against persons who are committing such fraud.
These situations do arise from time to time. In the drug area, we have investigational new drug regulations that require bona fide researchers and companies to provide quite substantial information to Health Canada. But whenever an issue of safety arises - there are some examples, perhaps, in your mind and in those of others around the table - it is possible for Health Canada to take action and prosecute persons who perpetrate these crimes.
The Chairman: Merci, monsieur Asselin. Mr. Forseth, please, followed by Mr. Adams and Madame Kraft Sloan.
Mr. Forseth (New Westminster - Burnaby): Thank you very much, Mr. Chairman.
I want to ask specifically about Btk spray for the gypsy moth, as it is proposed to be used in New Westminster, British Columbia this year. Does that fall under the PMRA? Whether it does or not, I'd like you to try to describe what happens right down at the street level in directly applying it to ensure that all the rules are followed. Who does that? Then describe the lines of accountability on upwards from the street level, when spraying is actually taking place.
Ms Taylor: The Btk is regulated by the PMRA under the Pest Control Products Act. It has been registered for the gypsy moth use, with all the health and environmental data that was considered necessary to register for that use.
The product in this case is being applied in British Columbia for gypsy moth control. It's being applied in certain cases by parts of Agriculture and Agri-Food Canada because the gypsy moth is still, I believe, a quarantined pest.
The agency itself works very closely with Agriculture and Agri-Food Canada on these issues and also with the provincial governments. We also have a regional staff that's very involved with the public in British Columbia.
Mr. Forseth: You talked about PMRA being a consolidation. Now you say that out in New Westminster someone else is doing it. So who's in charge out there?
Ms Taylor: There is a difference between regulation and use. We are involved only in the regulation. The use of the product is not in our hands.
The Chairman: In whose hands is it?
Ms Taylor: In a quarantine case, it would be in the hands of Agriculture and Agri-Food Canada to control a pest that's of some economic significance to the department and to the country.
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Mr. Forseth: I find that most interesting, then. We have a lot of process and a lot of so-called coming together, and then when we actually get down to the street level the supposed pay-offs of bringing together don't apply.
Ms Taylor: One of the strengths of the agency was to actually separate those two functions, to have the regulatory agency, not a user agency.
Mr. Forseth: So at the street level, when something is being sprayed, then, who's out there specifically ensuring that all the rules and regulations are being applied and that the actual people employed are qualified and all that kind of thing, right at the community level?
Dr. Anne MacKenzie (Director General, Food Inspection Directorate, Food Production and Inspection Branch, Department of Agriculture and Agri-Food): I would like to try to clarify for the committee that we have a large body of skilled inspectors in the regions, employed by the food production and inspection branch of Agriculture and Agri-Food Canada.
In the particular situation under discussion, the plant health inspectors in British Columbia employed by Agriculture and Agri-Food Canada are very much involved in ensuring that the procedures that govern the application, if you will, of this particular approved product are stringently adhered to. That's an inspection workforce that operates at the field level as opposed to the situation we have, as was described here, where you have an approval process of the substance being applied.
So I just wanted to clarify that. The inspection workforce at the field level looks after the application and ensures that all the provincial authorities are aware, that the public is aware, and that consultation and information sessions are held. That's the application end of this particular product.
Mr. Forseth: Well, that is a controversy in my riding. All those things you outlined about community consultation and all that: the end result, in my view, is a complete disaster. As a result of that, the provincial people intervened and stopped the spraying.
I'd like to go on to something else. This committee had made some recommendations to amend CEPA. In view of those regulation changes - the philosophy of a backstop or a safety net approach around section 26 - I wonder what further comments we could have about that from around this table.
Dr. Bailey: It is our view that it is most appropriate to follow through with the section inasmuch as products - a drug product, a food product and so forth, one that is traditionally regulated by Health Canada - would indeed come through that window for its environmental assessment. We think that is an appropriate route to take.
Mr. Forseth: Does anyone else have anything to add?
Okay, I'll pass it over.
The Chairman: I suppose what Mr. Forseth is pursuing is an intriguing question, namely, how is it that a department whose mandate is health, after having set the regulations, would transfer the implementation of the regulations to a department whose mandate is not health any longer, and whose mandate could at times be in conflict with Health's? I suppose that is what is puzzlingMr. Forseth.
Dr. Bailey: As I understand it, the idea would be that this would not happen. Indeed, Health Canada, under all circumstances, would be authorized to conduct the health assessment of such products. It would clearly -
The Chairman: In both its application and use?
Dr. Bailey: That's correct.
The Chairman: But a moment ago we understood it would be done by Agriculture and Agri-Food Canada.
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Dr. Bailey: Mr. Chairman, the safety assessment for human health would devolve to Health Canada. That is the case now for other products. The safety assessments are done within Health Canada.
The Chairman: You're talking about assessment, but what Mr. Forseth and I are pursuing is the practical application in the field of a substance, whether it is applied according to the prescribed rules as set out by Health.
Mr. Mayers: Perhaps I can offer some clarification. Health Canada and Agriculture and Agri-Food Canada have worked in very close collaboration in many aspects. We very firmly believe Agriculture and Agri-Food Canada has a very real responsibility in terms of product safety. In fact, as my colleague, Dr. MacKenzie, mentioned, the food production and inspection branch has a very real role in terms of safety. They, in addition to Health Canada, have responsibility for safety. We work in close collaboration with that department to achieve our mandate.
The Chairman: All right.
Mr. Adams, Madame Kraft Sloan and Mr. Steckle.
Mr. Adams (Peterborough): Thank you, Mr. Chairman.
I wonder if I could briefly go back to the safety net part of the government's proposal for a renewed CEPA. Some witnesses we've had have said that the safety net is not necessary. They actually saw it, in my interpretation, as interfering with their functions as a line ministry. I wonder if you'd care to comment on that. In other words, is this extra? Is the backstop, as I think Mr. Forseth called it, necessary? That's one thing.
By the way, as you're commenting on that, I was interested to hear you say that there are some substances that do fall through the system and still should be addressed. Could you...?
Dr. Bailey: It's a very complicated question. I wish I could clearly get through to an answer for you, Dr. Adams. But I would say the backstop approach is one that Health Canada believes isn't going to be necessary for those products we will be looking at, because they are going to come to Health Canada for an assessment in any event.
We all agree - I'm quite sure, as a matter of principle - with the principle of protecting the environment. When it does occur that there could be a situation where a product is not clearly falling within the mandate of a line department, it will have to have, or should have, the proper environmental control over it. Maybe that's where CEPA would be. But for those products where in the proposed CEPA they would be regulated by another department, we believe the control would be sufficiently there.
Mr. Adams: I'll go on to another topic. This is this business of transgenic crops, or whatever they are, and allergies. The example we've been given is the one of protein from a Brazil nut into a transgenic soybean, which in turn proved to be allergenic.
It seems to me there is a perception out there that all sorts of weird things are going on. That's on one side. Another one is the increasing appreciation of allergens. Obviously, the peanut allergy is the famous one, with peanut-free zones in schools and so on. It seems to me in these advances in biotechnology we're getting into very complicated situations where a vegetable one thinks of as being completely safe has in it something that is highly allergenic. That is a health matter.
I'll use peanuts as an example here, although I know you say it can't be done with peanuts. You start off with a peanut, it disappears into a potato and then goes from the potato into something else. Do you see what I mean?
I'd like your thoughts on that, and how it should be regulated. Do you, for example, on a routine basis test these new products?
Dr. Bailey: You might as well reply to this.
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Mr. Mayers: Indeed, allergenicity is a very important part of safety assessment. In terms of the proposed novel food regulation and the support for the novel food regulations in the guidelines for safety assessment of novel foods, allergenicity is a very important part of safety assessment. So for all novel foods, allergenicity and the potential for allergens is considered.
The first example you described was soybeans. This very clearly is an example of the system working. Brazil nuts are known to be allergenic. So importantly and correctly part of the safety assessment was an assessment for the potential for the transferred protein to be an allergen. This assessment demonstrated the protein was in fact an allergen. Development of the product was halted. It was never marketed. Consumers were never exposed to this product.
But in the broader context, allergenicity forms part of the safety assessment where an allergen is determined to be present in a food where it would not normally be recognized.
To use your example of peanut protein in potato, certainly someone who had an allergy to peanuts would not consider when they went into the marketplace that they should avoid a potato. In this situation, as Health Canada described last week when we appeared on the subject of food labelling, because the presence of a peanut allergen presents a very real health concern, Health Canada would require the product be specially labelled to identify the allergen. Consumers who were susceptible would be able to avoid this product.
Mr. Adams: We'll stick with the soybean just for a moment.
By the way, I really appreciate your answer. It is core to this case.
What happens when genetic material from the soybean is put into something else? Then genetic material from this something else is put into something else. So we're tracking the thing. Perhaps you could explain this to us. Maybe there is all sorts of genetic material that is safe and there is only this small amount of genetic material that is allergenic. Could you take us through this path and the regulatory side of it?
Mr. Mayers: Certainly. You raise a very important question, because we do recognize that in the thousands of genes included in an organism, only a small subset of those would code for proteins that would be potentially allergenic. The vast majority of proteins we're exposed to are, of course, not allergenic. That's why we don't have as many food allergies as we would if most proteins were allergenic.
You also raise a very interesting question regarding the potential for allergenicity. Not only do we assess the potential from known allergens, which is the case when we deal with peanuts or Brazil nuts and we know those are allergenic sources. In fact, for novel foods the potential for allergenicity is assessed as part of the safety assessment. This assessment is based on the principles of safety assessment we apply in using a comparison approach.
The characteristics of allergens are known. These are physical chemical characteristics. We apply a characterization of an introduced protein, for example, so the genetic material and the protein it codes for, in that assessment of its physical and chemical characteristics, might be similar to those characteristics associated with an allergen. Where there are in fact those similarities, then further specific assessment of that allergenic potential in terms of that particular protein would be conducted prior to an approval.
What this means is that even though you may go down the road several steps, as long as what you're dealing with is a novel food in each case, the potential for allergenicity will indeed be assessed.
Mr. Adams: I have a very last short question. And again, I appreciate your answers.
Going back to the soybean, is this genetic manipulation essentially an artificial process? Or is there a chance that by accident soybean producers or someone like that could start triggering one of these little sequences I tried to describe in the passing on of this allergenic substance? Does it have to be a deliberate artificial step?
Mr. Mayers: It doesn't necessarily have to be an artificial step, because we know many of the foods we eat currently, including traditional soybeans, contain allergenic compounds. We know those compounds are present, yet those foods are on the market. Those people who have a sensitivity avoid those foods.
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Mr. Adams: By the way, we are talking about people who are allergic to Brazil nuts, not allergic to soybeans.
Mr. Mayers: Understood. In this context, then, you are dealing with a very different situation. In order for a soybean to present this allergen, the allergen has to be introduced to the soybean. So unless soybeans had already present in their genetic code the potential to produce that protein, it could never be triggered. However, having said this, we do recognize evolutionarily changes to the genetic code do occur by traditional means as opposed to simply by genetic engineering.
So genetic engineering in and of itself does not create a unique risk of introducing these. There remains a risk from a traditional standpoint. The risk is simply different in terms of the ability to assess this risk, because in the case of transferring a gene from a Brazil nut we can address this.
Mr. Adams: Thank you, Mr. Chairman.
The Chairman: We will have a brief second round. We will go to Mrs. Kraft Sloan,Mr. Steckle, Mrs. Payne and the chair.
Mrs. Kraft Sloan (York - Simcoe): I'm sorry to be late and miss some of your presentation. I was tied up in the House. It would be useful to have written notes from your presentation.
I was wondering, from a human health assessment perspective, if a particular company is applying for commercialization approval from Health Canada for a genetically engineered, herbicide-resistant plant product - for example, canola or something like that - what the process is, what information is required, at what stages the information is required and what kind of tests are done. This is all in regard to human health assessment.
Mr. Mayers: The approach to safety assessment is outlined in our Guidelines for Safety Assessment of Novel Foods. This approach is based on principles developed by an expert committee of the Organization for Economic Cooperation and Development.
What the process does in terms of safety assessment is review the development and production of the genetically modified organism itself. It details a comprehensive characterization of the actual food product. So in your example the only food product from a herbicide-tolerant canola would be canola oil, the oil from canola.
It considers the dietary exposure to this product and whether this dietary exposure will potentially change based on the modification. In the case of the example, it is unlikely the dietary exposure will change. We know how canola oil is currently used.
Then a very detailed assessment of the nutritional quality of the product is conducted. This is based on the nutrient composition in comparison to the traditional food product. So oil from the herbicide-tolerant canola would be compared to oil from traditional canola in terms of its fatty-acid profile. We can do this analytically.
In addition, consideration is given where appropriate to the biological availability of those nutrients, because that also forms part of the nutritional quality of the product. The final portion of the consideration is the potential for allergenicity and for toxic factors. Those are assessed through the means I described for allergens and, in the case of toxic factors, through more traditional means of toxicological evaluation.
Mrs. Kraft Sloan: What do you mean by biological availability? Is this the body's ability to absorb the product?
Mr. Mayers: It is the body's ability to take up nutrients. That is correct.
Mrs. Kraft Sloan: Do you find there's a difference among transgenic materials?
Mr. Mayers: In none of the products assessed to date have we found this, and we don't anticipate we would find this. But because it is a part of safety assessment, it is applied to these products. We would apply it to any product we were conducting a safety assessment for.
.1630
Mrs. Kraft Sloan: Why is it that Japan has a ban on the importation of genetically manipulated canola oil?
Mr. Mayers: Japan is currently in the process of developing its guidelines. They have actually now published their guidelines for consultation. What they have indicated is that until those guidelines have been finalized they will not be in a position to rule on products. In Canada our guidelines have been in place since September 1994. We are simply further ahead than our Japanese colleagues. We have certainly been in consultation with them. They are also very active members of the OECD expert committees. They are in the process of developing their guidance document, and they have indicated that once their guidance document is in place they are very willing to assess these products for safety.
Mrs. Kraft Sloan: If a product is going for commercialization, is any kind of environmental impact assessment done?
Mr. Mayers: To use our example, that environmental impact assessment is in fact always conducted, and in the case of herbicide-tolerant canola, and indeed all crop plants, that is conducted within Agriculture and Agri-Food Canada.
Mrs. Kraft Sloan: So there's no one here who can speak to that process.
Mr. Mayers: Unless my colleagues from Agriculture and Agri-Food Canada would like to speak to that component.
Mrs. Kraft Sloan: The questions I had asked about health assessment were what is the process, what information is required, what tests are done. So what is the process for an environmental impact assessment of a genetically altered material, what information is required, and what stages does the testing go through?
Ms Margaret Kenny (Associate Director, Biotechnology Strategies and Coordination Office, Department of Agriculture and Agri-Food): The environmental assessment of novel plants is carried out by the Department of Agriculture. The kinds of things we would be looking at in these particular evaluations would consider items such as whether there is an increased possibility that this new plant could become a weed of agriculture or, for example, it could move into natural habitats.
We would look at this kind of thing on the basis of the biology of the original plant. If we were talking about a potato, for example, we would already have a great deal of information and many years of experience with how that particular plant reproduces, whether it's by tubers or it's by seed, and where we might expect to find it. For example, in a pine forest, do we now see many outbreaks of potatoes?
So we would look at it in that context. We would look at the new trait that has been added to the plant and determine if that trait gives it an additional advantage that would increase its possibility to invade new areas or become a weed of agriculture.
We would look at it as well from the point of view of whether it could be a plant pest in another sense or whether it would have any effect on any non-target species. Honey bees might be an example. That's obviously something we would be concerned with.
Those are the kinds of pieces of information we would be looking at in the course of our environmental evaluation.
The Chairman: Now Mr. Steckle, please.
Mr. Steckle (Huron - Bruce): I'd like to take us into another area. We speak very technically, and with most of the things we talk about here...most of us are rather new to this whole field of biotechnology, and some of the terms are beyond most of us. I would like to take us back.
When we look at the veterinary drugs, the drugs used in the treatment of human beings, and when we bring those on stream and they're given approval, what is the approval process? Is there a difference in the approval process? Perhaps you could comment on that. Is there a distinction or is there not? The results could be the same.
.1635
Dr. Bailey: Basically there is no distinction between the review process applied to a classical pharmaceutical and the one applied to a novel biotechnology drug which is perhaps going to be well characterized.
I won't take too long on the answer, but I think it's a question that actually covers a rather broad field, and it will take me a moment or two.
Pharmaceutical products are generally chemicals of fairly small molecular weight, and they are very well characterized - their chemical structures are very well established - and their manufacture is usually consistently reproducible. It's possible some of the newer biotechnology products will be relatively smaller materials. Some small proteins, for example, can be fully characterized and their molecular structure determined completely. Under those circumstances the chemistry and manufacturing, for example, could be subjected to perhaps a lesser degree of continuous monitoring and control by the department, because we know the manufacturer is going to obtain this material reproducibly, than for very much more complicated ones.
So if a manufacturer is now coming into the market with a recombinant product, as has been the case for human growth hormone, for example, which is a fairly complicated molecule although its chemical structure is in fact known completely, there the reproducibility of the manufacture is subject to variations and has to be exceedingly carefully controlled. Many biological drugs are made in media which readily allow foreign materials to reproduce: unwanted viruses, mycoplasma, and so forth, which you really cannot afford to have within the final product. Very rigorous and scrupulous manufacturing conditions are imposed on such biologics.
Then you come to some other biologics, which are even less readily characterized, such as vaccines that contain multiple components from perhaps a killed bacillus or a virus. They contain a multiplicity of different compounds, which again are produced by the manufacturer in a medium, a culture system, and again are subject to the dangers of adventitious materials possibly getting in. Some of them one doesn't need to worry about so much, because even if some adventitious agent were to get in it's possible to sterilize the product or to apply some purification procedure. In others such purification procedures might destroy the very product you are trying to make.
It's a long story. To cut it short, all of those data respecting the chemistry and manufacturing - I'm taking it for granted clinical safety and efficacy data are going to come in - are subject to rigorous review within the health protection branch by people who are experts in the manufacture of those particular types of products. So if it's an antibiotic that which may well be produced in fermentation but has a relatively small molecular weight and is easily separated, easily characterized and purified, that would be looked at by a group of experts on that side of chemistry. A complex vaccine would be looked at by vaccinologists and immunologists.
Ms Taylor: For the pesticides area, we have one set of guidelines for the naturally occurring microbial pesticides, but it also covers the transgenics. What we've found is that what we're dealing with - we've dealt with only one to date, but what we expect we might be dealing with in the future too - is really variations on the naturally occurring products. We've built up this volume of expertise in that area and they've been able to carry that on to develop those parts of the guidelines that are specific to the transgenic or the genetically engineering microbial organisms. There is a difference in the way they're handled in terms of additional data requirements to identify the organism, both the host and the donor, and they are treated more rigorously in the testing required and the toxicology area and the environmental area. It's a kind of continuum going on there.
Mr. Steckle: Once the approval is given - and we'll use the example of BST, because we all understand it's on the table; every time we have a meeting it's on the table. Given the fact that ultimately, if it's ever approved, it will come from Health Canada, if that approval is given and then ten years from now we find that it was a wrong decision - given that there have been those decisions made in the past - is there any liability here on the government or on Health Canada? Who is ultimately liable, given the fact that at some point in time we make a decision?
.1640
In basically every department we are talking about cost recovery. Do the pharmaceuticals, the Monsantos of today, pay the government? Do we have some cost recovery from these companies for the fact that there is due diligence done in terms of giving approval to these products, or is it simply something we do out of the goodness of being the government?
Dr. Bailey: No longer do we do anything, I believe, out of the goodness of being government. Certainly cost recovery applies to the review itself of the pharmaceuticals and biological drugs that now come into Health Canada. There is a cost recovery regime in place today.
I really don't feel qualified to answer your questions respecting liability except that I believe in all cases, as we recently have been seeing in inquiries - the Krever inquiry is going on right now - there is the possibility of investigations of any actions a government, or in fact anyone, may take these days. It is the responsibility of us all, I think, to exercise due diligence. Provided this can be demonstrated in the actions we're taking, then proceedings could of course ensue. We then would see what the outcome was.
But I don't really feel qualified to answer your question. Maybe one of my colleagues does.
Ms Taylor: Again, with respect to the pesticides area, the one area with which I'm familiar, we have, especially when I was part of the Agriculture and Agri-Food area that went to the agency, been taken to court in the past, mostly with respect to the failure of products to function according to the label. In those cases mostly it's both the chemical company, the registrant of the product, and the government.
I don't recall a single case where we've ended up paying compensation. Certainly there have been lots of settlements out of court between companies and those bringing the suits, but we have yet to have one. I guess that's the bottom line.
The Chairman: Thank you. Mr. Knutson, please
Mr. Knutson (Elgin - Norfolk): Thank you very much. I'd like to ask a question to our friends from Ag Canada and then I'll also have Dr. Bailey respond to the same one.
We received a presentation the other day from William Leiss, a professor of policy studies and eco-research, and chair of environmental policy at Queen's research. I don't know if you're aware of his argument. I'll try to summarize.
He doesn't believe regulating transgenic.... Let me put it more positively. He believes the regulations for new transgenic products, such as plants, shouldn't be in the jurisdiction of the proponent ministry, such as Ag Canada. He thinks that sets up at least a prima facie conflict - these are my words, now - and that a minister who is concerned with, say, the jobs agenda and increasing Canadians exports abroad perhaps might not pay the same amount of attention to environmental concerns as the ministers of health or environment might.
Part of his thesis was that the development of transgenic species or material is qualitatively different from anything we've done before. He used the example of taking a gene from a scorpion and putting into a virus to combat budworm, I think it was. His point - and again, I'm paraphrasing - was that this stuff is so novel, we have to do a risk assessment. The potential for positive is huge. We can't just put it in the closet and ignore it.
One, we need to make sure that the public is on side and it's credible, and two, that the risk assessment is being done properly. He doesn't think that's the role of Agriculture Canada.
.1645
I'll read a quote from the kit entitled Biotechnology in Agriculture: General Information:
- The role of the regulator is to balance public concerns for safety with those of industries that
wish to use technology to create national prosperity.
- That's a quote from Ag Canada.
First of all, he's purporting a new act to deal with transgenic materials, and secondly, he's recommending that it not be under the auspices of Ag Canada.
Dr. MacKenzie: Well, I'll try to answer without being aware of the document to which you're referring. I cannot speak with the advantage of having the total context of the document available to me.
On the point made by the document from which you're quoting on the conflict of interest issue, I think one must realize that every department in government has its own constituency. Fisheries and Oceans has its constituency, Agriculture and Agri-Food has its constituency, Environment Canada has its constituency. One's extension of the argument you're presenting could apply to not just one department.
I think the point that should be made is that there are so many checks and balances within the system that it would be very difficult to extend the argument and say that there would be the appearance of a conflict of interest here.
I want to go back to the question that was raised earlier about the appearance of duplication, because so many line departments seem to be involved in the regulation and approval of the products of biotechnology. I think it is just an indication of the various checks and balances that exist so that you do not have simply one agency or one department involved in all aspects of biotechnology. I think it's an indication that where the expertise lies on the individual products is exactly where those approvals and assessments should be done, clearly with Health Canada having the overall human health safety mandate.
Mr. Knutson: I can't dispute that there are checks and balances, but I think prima facie there is a conflict. You wouldn't agree?
Dr. MacKenzie: I would like to see the total arguments presented in the paper before I'd feel competent to comment on that.
Mr. Knutson: My argument would be that Ag Canada's constituency, more so than Environment Canada's, is farmers. In promoting the interests of farmers and the agrifood industry and producers, etc., they might take a different view from that of Environment Canada, and I see them as having a broader public interest mandate.
Dr. MacKenzie: My comment to that would be simply that our mandate is very clearly public health and safety as well as our other mandates. So in addition to Health Canada, we very clearly have areas where human health and safety is of great concern to us.
Dr. Bailey: I would support my colleague in her remarks.
Perhaps it would seem to be a lot easier for someone from Health Canada to be able to respond to such a question as yours, because our mandate is abundantly clear. Nevertheless, we too feel that within our mandate we have to pay attention to the prosperity of the Canadian pharmaceutical industry. In that respect, as I mentioned before, we have performance standards that we do try to adhere to in order to ensure that the industry will know, when they make representations to us, what they can expect with a quality submission, how long it will take us to review it, and that we will be doing a health and safety and efficacy assessment. Respecting conflicts of interest, then, I think they would scarcely be considered within Health Canada.
.1650
You mentioned also the interesting proposition about there being a new qualitative difference and you asked for comments on that. Again, I would perhaps need to look thoroughly at whatDr. Leiss said, but it did strike me that it sounds a bit recidivist of what was happening in the 1970s, when the Asilomar conference was called together. This was a conference after the discovery of recombinant procedures. A great deal of concern was expressed at that time, because the science was really in its investigational and early stages, about what might possibly come out of all this. Perhaps that was reflected in the backdrop of concerns about atomic energy and so forth. So in the 1970s a short moratorium was called on these types of procedures while the science was really being investigated. We now have an experience of almost a quarter of a century of advancement in our knowledge of this.
I think we have basically, as my colleague from the Pest Management Regulatory Agency identified it, seen a continuum. We now understand much more the continuum of life across what has been traditional breeding and what is now a more targeted type of change.
Mr. Knutson: I want to interrupt and take you back to the conflicts issue. Do you think it matters whether the Pest Management Regulatory Agency is under Agriculture Canada or under Health Canada?
Dr. Bailey: I'm very happy to have them with Health Canada. I think it's entirely appropriate that they be where they are. But that's a policy decision, I think.
Mr. Knutson: Given what I said earlier, is that possibly to avoid a conflict between a proponent and the agriculture department wanting to promote certain things and perhaps not putting the same weight the health department might put on it?
Dr. Bailey: As my colleague Dr. Sexsmith described it at the beginning of her presentation, the reasons for putting this together were both scientifically sound and quite pragmatic.
Ms Sexsmith: As you know, this was a government decision taken after many years of evolution towards this. It started in the late 1980s, where there was some indication that there was dissatisfaction with the system and the system should be changed. Government went through a number of approaches to the change and finally came to the approach we are now living with, which is maybe the best place for it. Certainly there was real agreement that it should be consolidated in some way, because it was thought it would be a much more efficient way to do business and there would be absolutely a one-window type of approach.
Mr. Knutson: About the paramountcy argument, that we can't trust Industry Canada or take Agriculture Canada off the hook for a second, we can't trust the minister or department that's basically about jobs and economic growth to give the same weight to human health as we could expect from Health Canada, maybe it's an oversimplification, but at least at first glance it seems to me to have merit.
Ms Taylor: Having lived through both, having been with Agriculture when the pesticides were there, and now with the agency...there is an enormous advantage in the agency from the consolidation itself and the efficiencies we gained. But while I was with Agriculture, although Agriculture had authority for the act and regulations, many of the actual reviews were done in Health. In fact, all the health reviews were done in Health. Although we discussed and debated the regulatory route to take on certain products, there was never an inclination within Agriculture to overrule a Health finding. That simply wouldn't have been very smart.
The Chairman: Mr. Lincoln.
Mr. Lincoln (Lachine - Lac-Saint-Louis): I will follow up on this question briefly, having been involved in all the discussions that led to transferring the jurisdiction on pesticides to Health. I remember I was one of the few members who got assigned to put together the implementation of the task force report, which had taken two years. If my memory serves me, one of the main thrusts of the task force and the overall testimony of Canadians was that it should be assigned to a cross-cutting agency of government that was much more horizontal in nature and much more objective because of its mission to protect the health of Canadians. This was a paramount reason that changed it to Health from Agriculture.
.1655
I think it must be borne in mind that whether we accept it or not, the fact is that there are some ministries of government that are much more cross-cutting, much more horizontal in their objectives and missions. Certainly for Finance we can't say that. It doesn't touch all the ministries. Health is one of them. In my view, Environment is very much one of them.
When Dr. Leiss made his position clear the other day, he certainly wasn't very kind to the Department of the Environment. He said that the Department of the Environment had to improve its efficiency in regulating to a great degree.
He heaped a lot of praise on the Department of Health for its regulating efficiency, but he did view that in the mind of the public at large there are some ministries that have done a public good. This is one view that I share very deeply. It's not that all ministries don't do it, but they are line ministries and some of them are much more cross-cutting and much more horizontal in their mission. If we say that the main objectives are the protection of health and environmental safety, these would be the two logical ministries. That was the point he made, and I happen to think he's right.
What I wanted to ask Dr. MacKenzie and Dr. Bailey is this. If we didn't have a system in place, putting aside all questions of jurisdiction on whether this ministry should do this and the other one should do that, and if we had to set up criteria for a system of regulating biotechnology, I wondered whether you would agree on the following points as key criteria for regulations in biotechnology.
First of all, health and environmental risk should be paramount. They should cover all products and processes of biotechnology. I must say I know a lot of reports that have been given to us show, or the witnesses have said, that products and processes can be regulated in the same way. Dr. Leiss, for one, made the point that if we take meat processing, for instance, and all the regulations relating to abattoirs, the process and the products are treated in the same way.
There should be no conflict of interest involved in accepting in very broad sense whatDr. MacKenzie said. Whatever ministry there is, there's always some degree of conflict of interest. There should be pre-manufacturing and import notifications, there should be proper assessment and evaluation, and there should be public notification and input by the public.
Would you tend to agree with these or do you have any reservations about any of them as criteria?
Dr. Bailey: I'll address it first and then my colleague can correct me.
I would agree with the criteria you have identified. Your premise at the beginning was if we were to regulate biotechnology. That indicated to me that you were starting with a completely fresh slate.
Mr. Lincoln: Yes, because I didn't want to get into a debate as to whether agriculture should do this, health should do this, and environment should do this. I just want to leave this aside for now because I realize that positions are very divided on this issue.
Dr. Bailey: You were talking then of regulating a process. The industry itself is a product line industry. I think there would be practical difficulties as much as anything.
I would totally agree with the principles you've identified. I think they are quite correct. Within Health Canada and the other line departments, I do believe that at present we do try to minimize conflicts of interest, as you said. We are looking for a proper assessment. We are looking for pre-manufacturing input.
.1700
You started off that health and environmental concerns should perhaps be dominant. Naturally, in Health Canada they are. In Health Canada we also have this wrinkle inasmuch as in the area of drugs, at least, there is a risk and a benefit being assessed, not just a risk assessment, to cover all products and risks of biotechnology, and whether the products and processes could be handled the same.
In the case of biotechnology drugs, as I was describing to a colleague of yours just as you were coming in, because of the nature of such products, the processes can in many ways define what the product is. From your remarks I believe this may have been presented by Dr. Leiss yesterday. A biotech drug is defined by the way it's made. So a great deal of attention is applied to that process - not because it happens to be called biotechnology but because it's a process fraught with difficulties, problems and dangers and is not necessarily as reproducible as one might suppose.
Mr. Mayers: To add to that, these criteria don't just apply to products of biotechnology. These criteria are appropriate to most products that we regulate, to most products that might present a consideration for pre-market assessment. I think this list of criteria is not a biotechnology-specific list, but it outlines a framework in terms of safety assessment that we in the health protection branch and in Health Canada take for the products we regulate, as opposed to just products of biotechnology.
Dr. MacKenzie: I want to add a point of clarification on the product versus process confusion. I think there is a lot of confusion around what that really means. We in Canada, and certainly those in many other countries, have determined that we won't look at these criteria that you have defined just when we're talking about a product that comes from recombinant DNA, or from recombinant technology.
Just as my colleague in Health has indicated, we believe that assessing the safety of these products in terms of human health and safety, and environmental health and safety, is important regardless of the process or technique that has been used to create that product. So the regulation we have in Agriculture, and those in Health Canada, capture much more than you would find if we were just talking about recombinant technology, which is what Europe has largely gone to. So we will deal with a new crop, even if it comes from traditional breeding, if it has a new trait that we're not familiar with here in Canada. When we're talking about product versus process, I think we're talking more about the trigger. We're not satisfied just looking at products from recombinant DNA technology. We need to look at that in a broader sense.
Mr. Lincoln: I think this question of product and process has led to a lot of confusion, certainly in lay people's minds. I find it hard to distinguish between regulating the product.... Consider blood and all the kerfuffle we've gone through with blood. You have a product and you set criteria for clean blood, but surely the process to arrive at it is also extremely important, as is the process to distribute the blood and administer it. I think that was the point Dr. Leiss was trying to make.
.1705
I agree with you we shouldn't have a conflict between the two and say one versus the other. But should we merge them so when we regulate we don't make a distinction between the product and the process leading to the product? As Dr. Bailey was saying, if I understand well, when you are looking at a biotechnology product, surely you have to look also at the way it's processed, the clean rooms, and all the processes.
So in regulating, why should we make a distinction between the two? Why shouldn't our regulations cover it overall, including the process?
Ms Kenny: It's a very, very good point you've raised, and that is a point of confusion. We do. We have hired in specialized expertise, certainly within the branch I work in, so we can look at the process that has been used as part of our evaluation.
Dr. Bailey: Perhaps I could supplement my colleague's remarks.
Certainly good manufacturing practices regulations are in place for pharmaceuticals, very specific regulations are in place for the manufacture of certain biologicals, and good manufacturing practices are being introduced for the manufacture of biotech and other biological drugs. GMPs - good manufacturing practices - are essentially the process. So the process is indeed regulated, but products have standards that are set within regulation, and that is more easily identified, perhaps, and it's more easily seen that here's a product, it's met a standard, it's labelled. But to me that standard, the process, has been thoroughly evaluated and continues to be evaluated.
Mr. Lincoln: When the Canadian Institute of Biotechnology appeared here, they made the point that with the review of CEPA and the proposing of safety nets and so forth a lot of confusion had appeared in the minds of legislators, of various departments, of the public, and of themselves. In fact, this is the reason why this committee is having hearings right now. They suggested that - and I asked them specifically so I made sure I understood it properly - until we have developed - andDr. Leiss made the same point yesterday or the day before - some sort of broader framework such that we know exactly where we're going, department to department, leave well alone. If it ain't broke, don't fix it. They suggested we just leave the present set-up until we have defined this thing more clearly and we know exactly where we're going.
Would the representatives of the department comment? In other words, he said the status quo is better than just tinkering with it. In the medium term let's do it properly. In the meanwhile just leave the thing.
Dr. Bailey: Certainly I would say the record of work done by the departments, which has been done collaboratively and with agreements through the subcommittee on safety and regulations for biotechnology run out of Industry Canada...the departments have thoroughly tried to work together to ensure a proper framework is in place. I think the record of safety in biotech, at least at the moment, speaks for itself.
The Chairman: Thank you for putting this on record.
I would like to deal with a couple of items of a housekeeping nature while we have a quorum. One has to do with a request to cover travelling expenses by Dr. Curran to attend a conference on June 23 to 26, Risk Assessment at the Crossroads. Could I have a motion to the effect that this expenditure be authorized?
Mr. Adams: I so move.
Mrs. Kraft Sloan: Seconded.
The Chairman: Any questions or any discussion? Do you want to know the amount? No?
Mr. Steckle: Mr. Chairman, where is the conference being held?
The Chairman: Here in Ottawa. But even if it were in Timbuktu, it may be desirable that he attend it. Could we have concurrence?
Motion agreed to
[Translation]
Mr. Asselin: I have a question, Mr. Chairman. On this sheet of paper that I've received, it says:
- That the Committee authorize expenditures for Tom Curran, Research Officer, Library of
Parliament to attend the conference entitled ``Risk Assessment at the Crossroads'' to be held in
Ottawa June 23 to 26, 1996.
The Chairman: That's right.
Mr. Asselin: Since this is staff that is already in Ottawa, then why is it different...
The Chairman: The registration fees, sir.
Mr. Asselin: How much are they?
The Chairman: Thirty dollars.
[English]
Done. Sold for $30.
The other item has to do with what is before you. It is the standing committee's report on the Yellowknife conference on the Arctic, with recommendations affecting the regions north of 60, and also the Inuvik ministerial conference. It is a recitation of what was said and done. It is a report that would be desirable to make to the House of Commons for the record.
Could I have a motion to that effect?
Mr. Adams: Will the motion be first, Mr. Chairman, or comment on it?
The Chairman: We will have the motion first and then comments and questions.
The motion would possibly read that the report be adopted and that it be done in a manner that would request the government response pursuant to Standing Order 109, which is the regular system. Could I have a motion to that effect, and then questions and answers?
Mr. Lincoln: So moved.
The Chairman: Are there comments?
Mr. Adams: It seems to me that while it's a very worthwhile report, it would be useful and not difficult to include a mention of the CEPA report, simply to keep awareness of the northern portions of the CEPA report in currency. In the beginning where it says that the standing committee has had an ongoing interest in the Arctic region, it would be quite easy to insert there that in its major report, our CEPA report, the Arctic is dealt with in some detail.
The Chairman: It's a very good suggestion, Mr. Adams, but CEPA was not included in the discussions. Therefore we cannot make that suggestion, unless someone knows of a way of doing it that reflects the proceedings. To my knowledge, it was not dealt with in the hearings in Yellowknife.
Madame Kraft Sloan.
Mrs. Kraft Sloan: In the fourth paragraph where it says ``special attention'', could you add ``historical''?
The Chairman: In the fourth paragraph on page 1?
Mrs. Kraft Sloan: Yes. It says that special attention was paid -
The Chairman: Yes, on the third line.
Mrs. Kraft Sloan: Could you add ``historical'' in there?
The Chairman: We have to insert ``historical''. Fine. Thank you.
Are there any other suggestions? Could I have concurrence to table it?
[Translation]
Mr. Asselin: Mr. Chairman, I have a question. I agree entirely. Unfortunately I haven't read the report since it's just been released, but it seems excellent.
I see that you include several recommendations to the government in your report. I agree that the report should be tabled in the House but shouldn't the government be given some time to get back to the committee regarding its recommendations and the overall report? If the matter does not come back before the committee, then it may well die on the Order Paper.
The Chairman: Yes, that is the order we will adopt and it will give the government the time it needs to report back. That will happen.
Mr. Asselin: Do you think it can be settled during the 35th Parliament?
The Chairman: Yes.
Mr. Asselin: Thank you.
[English]
Motion agreed to
The Chairman: It's ordered. Thank you.
Now, back to our business here. I have several names for the second round. However, allow me to pursue this matter of the logic of product versus process, a question that perhaps needs to be pursued.
According to Dr. Bailey's statement to this committee a month ago, he said to us:
- Under the regulatory framework, Agriculture and Agri-Food Canada assesses the fate of the
final products rather than the actual processes of biotechnology, with the belief that genetically
engineered organisms are not fundamentally different from traditionally bred organisms. This
means that each new product is evaluated on its own merits and characteristics, and not on
method of its production.
Do you recognize that statement?
Dr. Bailey: Yes.
The Chairman: Fine. Let me now read the other statement you made, apparently on the same occasion:
- Through new biotechnology techniques, scientists can modify the characteristics of organisms
for our benefit in a more controlled way than with traditional practices.... These techniques
allow the transfer of genes to be carried out in a very controlled way, so that only one or a few
desirable traits are transferred at a time. Furthermore, these technologies can be used to
introduce desirable traits from outside the species, something that is not possible with
traditional breeding methods.
Dr. Bailey: I would certainly agree with it. I can't remember now whether Dr. Morrissey said that or I said it, but I would agree with it.
The Chairman: It was one or the other.
Do you see a contradiction between the first and the second statement?
Dr. Bailey: I think if I may, Mr. Chairman, as for the issue on process, as perhaps identified by colleagues earlier, such that biotechnology is somehow going to be so different or require a very different approach to evaluating the products or the safety of the processes from other types of processes, I wouldn't believe that is the case. However -
The Chairman: The first statement, whoever made it, was telling us that the genetically engineered organisms are not fundamentally different from traditionally bred organisms. Then in the second one, the statement was to the effect that new technology does something that is not possible with traditional breeding methods. So what are we to conclude from this?
Dr. Bailey: I believe the fact that they are not fundamentally different relates to the fact that all living things are composed basically of the same type of genetic information.
The Chairman: Nevertheless, there is quite a difference between the two, wouldn't you agree?
Mr. Mayers: There is a difference; I don't think that difference is fundamental. In both cases, there is an exchange of genetic material. Recombinant DNA technology simply permits you to select that genetic material from a broader selection, potentially.
That doesn't mean that this may not have happened traditionally, because we know, based on evolution, that genetic material has in fact crossed species barriers.
What recombinant DNA technology allows us to do is do that in a much more controlled fashion. But the fundamental issue is the fact that genetic material, regardless of its source, is the same; therefore, the source of a gene does not raise a fundamental concern irrespective of whether it is within the species or outside the species. The genetic material is the same in all species; therefore, its source does not present a fundamental difference.
The Chairman: This is why we have a great problem in following you guys in your thinking. We can see a substantial difference emerging between what is described in textbooks as traditional biotechnology and new biotechnology. The new biotechnology is the one described to us by you people and others as the one that is called transgenic interspecies transfer. There we see a scenario that is profoundly, dramatically different from the one you can see when looking at cultivation and breeding, and interspecies gene transfer, as they call it. The difference between the two is enormous.
What we are seeing here as a result of these emerging two sectors, so to speak, is a rather strange amalgam of measures that is confusing the observer and us, rather than making it clearer for us to understand what is going on.
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It seems to some of us at least that there is a very legitimate area for a regulatory role on the new biotechnology, the transgenic field, which is where the attention is shifting of the parliamentarians, as already as indicated by the questions asked by Mr. Knutson and Mr. Lincoln. We see a line between the traditional biotechnology and the new biotechnology, and we draw it at the point where transgenic entities, or interspecies transfer, as we have been told, become the object of human activity.
Ms Sexsmith: If I may, perhaps I could try with the Pest Control Products Act and pesticides as an example. First of all, that's the slice we have: the PMRA or the Pest Control Products Act. It essentially says that if a pesticide is to be used in Canada, it has to come through that window, which is the PMRA. It has to be evaluated, reviewed and ultimately registered. That includes looking at the process. So the slice is really okay if it's a product, as this is the window it comes in, but that evaluation includes the health and environmental evaluation as well as looking at the process.
So if you're a virus, like Bill Leiss referred to yesterday, or a microbial, then you're going to be used as a pest control product in Canada and you're going to come to the PMRA. You're going to come in that window.
If that virus happens to have a gene inserted into it - it was suggested yesterday that this could be a scorpion gene in this virus - it will come through our system presently. Essentially, as my colleague indicated earlier, we've been looking at these things for many years now, and our process is science based.
So the science-based process that we developed and learned to work with and in, based on our knowledge of the microbials we have been working with and so on and so forth, is the basement or the bottom part of the knowledge we would use to deal with the extra bit you would need to know about some of these changes.
So I guess our view is that you fundamentally have to understand the science of the parents, the cousins, the aunts, whatever, of the product you're dealing with in order to be able to deal with that extra little bit as well. I guess what I'm trying to say is if you're looking at a virus, such as a virus that has had something changed about it, that expertise dealing with viruses is the expertise you need. The issue of where it's going to be used and how it's going to be used all has to be factored in. So it would be the same people looking at the same science, plus the extra bits, and making those decisions based on all this other information that is very similar.
The Chairman: Let me ask you then this question. Would you agree with this statement? When it comes to traditional biotechnology, cultivation, breeding and interspecies gene transfer, human intervention appears as the manipulation of processes that are otherwise occurring in nature routinely, albeit at a different pace. But when it comes to the new biotechnology, namely the transgenic stuff, then this intervention represents a qualitative transformation in that what becomes routine here is anomalous with respect to natural processes. Would you agree with that statement?
Ms Sexsmith: I think I do, yes. It is different.
The Chairman: Would you agree with that, Dr. Bailey?
Dr. Bailey: I would.
The Chairman: You would. Thank you, because this is very helpful to us in determining the direction we should be taking. Would you like to perhaps comment further?
Dr. Bailey: I think it is different inasmuch as, for the first time, humankind can take a gene, usually very specifically identified, and for a very legitimate purpose, isolate that gene. Then through modern scientific methods, it's put into a species in which that gene will express a product that is desired or a trait that is a desirable one.
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That couldn't have been done before. That is where I agree and say, yes, there is a change.
As indicated by my colleagues and myself earlier, it's nevertheless the same fundamental process of life that's going on within this new species. Whether it be a rose that somehow has had a gene put into it that would express blue pigment to make a blue rose, or it be an E. coli bacterium into which a gene has been put that will express human growth hormone, or a mouse into which a gene has been put that will express a human breast cancer receptor, something has been done there that, given the system of things, up to the present would not have occurred naturally - perhaps not in millions of years.
So there is a difference, but the life process itself isn't different. What we see is a great deal of control being able to be exercised over that change, which didn't occur before in the more natural processes of interbreeding horses or getting different species and varieties of dogs.
Do we need to be concerned that we have taken a step that seems to be different, and is there real danger in that step? This was the question that was being asked 25 years ago at a seminar, as I mentioned, and we have now had 25 years of experience where it would seem that, although a fundamental change in technology has become available to us, very excellent controls are in place. In fact, we now have reaped the benefits of this type of work, especially in the human health side, of course, and in advanced crops.
We have not seen pigs' legs on tomatoes, or whatever you were suggesting, Dr. Adams, the last time we were here. We understand, I believe, that we can specifically transfer genetic information and use that in a very controlled manner.
Maybe my colleagues would wish -
The Chairman: Are there any further comments on this before we start our second round?
Ms Taylor: Yes. Thank you, Mr. Chairman.
This is where the process that comes in is very important, but really in the end you have the same questions: whether it's a naturally occurring event or whether it's a bioengineered event.
The questions, for example, in toxicology in the guidelines we've developed for the microbial products are one such as: is it an acute oral toxicant, is it an acute pulmonary toxicant, is it infectious, does it cause hypersensitive reactions? Those are all the same questions. We ask those when it's a naturally occurring indigenous organism. We ask that when it's naturally occurring but not indigenous or native to the area in which it's going to be used. We ask that when it's a kind of natural mutation, and we ask the same question when it's genetically engineered. Those are the questions we need to have answered for all of them.
Mr. Forseth: I have a point to make, and then I'll ask a very specific question. Time is running out.
Mr. Steckle alluded to a point earlier about, in a general sense, who is accountable, especially when things go wrong, this general business of liability. Certainly in the ultimate sense it is the minister and the government that is accountable for the success or lack of it of its government departments.
Modern government would like to walk away from the traditional ministerial accountability rule, and I find it somewhat surprising that representatives from government departments didn't have that answer on the tips of their tongues at first. Government departments have a tremendous responsibility, especially for the topic we just talked about in the last question, and with that comes accountability, ultimately resident in the minister and the government.
I want to ask you a specific question. Can the witnesses state whether from the department's point of view it's preferable to regulate biotechnology products under comprehensive guidelines, as maybe the industry wants, or under regulations?
The Chairman: Try to answer in 30 seconds.
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Dr. Bailey: Guidelines offer a great deal of flexibility. They usually do not have less force in practice than regulations do. Companies issued guidelines by a regulator, as, for example, Health Canada does a great deal, are bending over backwards to adhere to those guidelines. Because regulations take time to put into force, just in practice, getting them through the legal system - guidelines usually can be brought up to date very rapidly, and adhered to by the industry very rapidly - they are regarded as a desirable means of effecting the proper control and advice to the regulated industry.
Mr. Forseth: Specifically related to biotechnology? What's your recommendation?
Dr. Bailey: I would go with guidelines. As I have indicated, we are able to be, in discussion with colleagues from different government agencies, including our international colleagues, at the forefront of science to ensure that the types of provisions put in place respecting those products are state of the art, if you wish, or front edge, to be sure that we are really where the sciences and the regulatory controls should be. We have been doing that with recombinant products, monoclonal products and so forth - in Health Canada, at least.
Mr. Forseth: Thank you.
[Translation]
Mr. Asselin.
Mr. Asselin: Since we have with us officials from Health Canada and Agriculture and Agrifood Canada I would like to take this opportunity to ask about Quebec's dairy producers. Several questions have been asked in the House about this and a demonstration on Parliament Hill got a lot of press coverage. I would like to know what went on between Health Canada and Agriculture and Agrifood Canada concerning industrial milk and raw milk cheese. I would like to know whether Health Canada and Agriculture and Agrifood Canada believe that raw milk cheese could be harmful to consumers. Could we see labels on raw milk cheese saying ``Approved by Health Canada'' and ``Approved by Agriculture and Agrifood Canada''?
[English]
Mr. Mayers: The issue of cheese made from raw milk is the subject of a regulatory proposal that currently is coming to the end of the comment period. Health Canada has proposed regulatory amendments that would make some modifications because of public health concerns related to the presence of micro-organisms that can cause disease and that are capable of being present in cheese made from raw milk and in some cases even growing in those cheeses.
That issue is the subject of a regulatory proposal to amend the food and drug regulations to put in place the requirement for pasteurization, or certain heat treatment plus storage, which would provide a level of public health protection equivalent to pasteurization.
[Translation]
Mr. Asselin: Thank you, Mr. Chairman.
The Chairman: Mr. Adams, please proceed.
[English]
Mr. Adams: I think what I'm interested in - I've been trying to think about it - is the natural spread of something that has arisen as a result of targeted change. I'm still talking about Brazil nuts and soybeans.
We've all seen the movie. What happens is Health Transylvania, or Agriculture and Agri-Food Transylvania, produces, through targeted change, a mutated - as it's called - bacterium. The bacterium gets away into the environment. At that point that's a targeted change. By natural breeding - if that's what a bacterium does - it spreads. The hero chases it and just gets the solution when it mutates, which actually means it naturally breeds again. The solution doesn't work. Then it mutates again. In the end the environment kills it off, or something like that.
An hon. member: What movie was this?
Mr. Adams: I know we've all seen the movie.
So we have an allergenic protein from a Brazil nut. It's in this soybean. The soybean is out there now. So the targeted change has occurred. It's out there now in the natural environment.
What I'm really after, with regard to that protein that's producing the allergen, is this. In the natural process, what are the risks out there of it going into other soybeans that have not been targeted, or going from soybeans to something else?
Mr. Mayers: The potential for transfer of that genetic material through traditional means, through breeding, would be limited to those possibilities available to soybean and its relatives. That potential would have to be addressed as part of the environmental assessment in terms of any restrictions on growing that crop in proximity to non-modified soybeans, for example.
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If that were to be approved, that product would have specific requirements regarding the labelling of that product. To ensure that you could conduct that labelling, that product would have to be grown segregated. It would have to be processed segregated, and it would have to be maintained segregated through its entire processing.
So restrictions would have to be in place to ensure that segregation. Those restrictions would come through the requirements from Health Canada in terms of the health aspect, which would be addressed through labelling, should such a product proceed, and through the environmental component in terms of its restrictions, to ensure segregation.
The Chairman: Madame Kraft Sloan.
Mrs. Kraft Sloan: Can you give a 100% guarantee that something like this would not migrate?
Dr. Bailey: I would never give a 100% guarantee on anything. As my colleague Dr. Morrissey said last month, we have to take the science as we know it and understand it today; we will learn more things in 10 years' time.
The stability of constructs of such materials we were just speaking of is a part of the submission that must be made before they are approved, whether it goes to Agriculture or to Health Canada or whomever. A great deal of information is provided in the submission respecting the ``construct'', as we call it. This is the new genetic thing that is going into the species and its transferability.
Mrs. Kraft Sloan: How would the precautionary principle play out in the field?
Mr. Mayers: In essence, our pre-market notification requirements focus on the precautionary principle. The approach we are taking is requiring pre-market notification to permit a safety assessment prior to these products reaching the marketplace.
The Chairman: Mr. Lincoln, please.
Mr. Lincoln: Just to follow up on Mr. Forseth's remarks about regulations and guidelines, if I understood you right, Dr. Bailey, your argument was that regulations are very unwieldy today and very long in processing. If the Statutory Instruments Act, which controls the whole process of making regulations, were modernized and updated so that regulations could be put together much faster and much more efficiently, would you agree that regulations are a much better safeguard than guidelines for the public good, especially in a field as delicate as this?
Dr. Bailey: It would appear to me, the way you have described the situation, to be yes, but with the situation we have on hand today I do believe guidelines are in fact being used extremely well and extremely carefully.
Mr. Lincoln: Do you see a time in both Health and Agriculture and Agri-Food - and perhaps one of the Ag Canada representatives could answer this as well - when we will see more deregulation and more devolution to industry associations or institutions of sorts to take care of monitoring and assessment, to take charge of things on behalf of the departments?
Dr. Bailey: There is a move in that direction already. I'll very quickly allude to what is going on south of the border, where environmental assessments, in at least some cases, with respect to pharmaceutical products are being devolved to groups put together by the regulated industry itself. They will provide the first of the environmental assessments, since this is a committee on sustainable development and environment.
As well, I'll quickly refer to the fact that we within Health Canada are using expertise resident in learned societies, professional associations, trade associations and so forth to assist us in inspection activities - for example, the accreditation of facilities - all of which support the regulatory process and are less resource-intensive on departments.
So we are certainly looking in those directions, but they have to be carefully worked forward. They have to be carefully audited, and procedures do need to be put in place to ensure that if we do move toward this accreditation route, it can be adequately managed.
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Ms Kenny: Perhaps I could add one word, and that is that in Agriculture one of the most important undertakings we have in place right now is to get our regulations forward for products of biotechnology.
The Chairman: Are there any comments?
Ms Taylor: We have operated with guidelines for many years. Our regulations, as I stated earlier, are general, but they outline the kinds of data required. What we find is that the guidelines allow for interpretation depending on the results of one study, whether or not you go into another study. We also find that if you simply have the bottom line that you won't register the product until they've satisfied the data requirements, according to the guidelines you almost in effect have a regulation. At least that's the way we've used it and the way we've experienced it. So they have to meet the guidelines.
The Chairman: Thank you. The bell is ringing. Tomorrow we meet at 9 a.m. with an interdepartmental committee. Please remember that it is at 9 a.m. This notice is in your office.
We thank you very much for your participation this afternoon.
This meeting is adjourned.