Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 21 - Evidence
OTTAWA, Thursday, October 29, 1998
The Standing Senate Committee on Agriculture and Forestry met this day at 9:02 a.m. to study the present state and future of agriculture in Canada (recombinant bovine growth hormone, rBST, and its effects on the human and animal health safety aspects).
Senator Leonard J. Gustafson (Chairman) in the Chair.
[English]
The Chairman: This is the third meeting of the Standing Senate Committee on Agriculture and Forestry on the subject of the use of rBST to stimulate milk production in dairy cattle and its implications for human and animal health safety.
In June, the committee heard testimony from representatives of Monsanto, the company which is proposing to market rBST, and from senior officials of Health Canada. Since then, the committee has received over 200 letters and e-mails from the public expressing their concern and asking the committee to study this issue more closely.
Last week we heard testimony from Health Canada scientists who reviewed the methodology used by the department in its evaluation of rBST to date. We also heard from representatives from the Dairy Farmers of Canada and from the National Dairy Council, the producers and processors of dairy products in Canada.
Today we will hear from Health Canada officials and then from a panel of representatives from the Council of Canadians and the National Farmers Union.
We have before us, from Health Canada, the Deputy Minister, Mr. Dodge, and his assistant, Mr. Nymark. I understand that they will introduce other people later. Mr. Dodge will make a short statement, and then we will go to questions in regards to some of the concerns raised by the scientific community that appeared before us. I would ask Mr. Dodge to begin.
Senator Spivak: Mr. Chairman, on a point of order or a point of clarification, I had understood that Dr. Losos was appear. I see his name is on the list, but I did not hear you mention him. You indicated that we will first hear from the people from the Department of Health and then from the other witnesses on our list. I had understood that we would look at the affairs within the department first and then get on to other questions. Is that your understanding? Is that the way the questioning will go? That was my understanding prior to this in terms of our agreement.
The Chairman: That is my understanding. Mr. Dodge is prepared to answer questions in that regard, I understand. We will ask him for his statement at this time.
Mr. David Dodge, Deputy Minister, Health Canada: Honourable senators, thank you for inviting me here today on this important issue. Obviously, on reading the transcript from your last session, I was extremely concerned. I said that if the senators wanted me to appear, I would certainly be here.
As you all know, I am new to the department, having arrived in July. I have barely finished my first quarter. I have come to the Health department because I believe that the health and safety of Canadians is probably the most important issue facing us today. It was an honour that the Prime Minister asked me to come back from my comfortable chair at the University of British Columbia and take this on.
As Senator Spivak has said, there are two sets of issues here before us, and they are obviously interrelated. While I have done a lot of empirical work in my life, it has all been on economics and numbers and not on human health and safety. I am not someone from whom you want to hear much with respect to the science itself. However, we do have Dr. Losos, who is our chief scientist from the department, the heads of the two outside review panels, and a world expert who has flown all the way from Australia to be here to try to help you through some of these issues. They will deal in the second half of the session with the scientific issues.
Let me start by turning to more general issues. It is extraordinarily important that all Canadians have total faith that the food products they consume or the drugs they use are indeed safe to the highest standards of science that we can apply. There is no 100 per cent guarantee of anything in this world. Science changes, and our knowledge changes over time. However, to the extent possible, that is the job of the department; that is the commitment of the department; that is the commitment of the minister; that is what I have been asked to come and do.
A number of accusations made last week are extraordinarily serious. As the Deputy Minister of the department, I am extraordinarily concerned about them. It is important that we have processes to get to the bottom of those.
It has been my observation in my very short tenure that over the last year or so there has been, under Minister Rock, a real effort to rebuild the Health Protection Branch, a branch that is adequate to serve Canadians as we move into the 21st century and a branch that can deal with what we expect to be a flood of new, genetically engineered products which are rather different from what we have been dealing with over the years. That job is difficult. Once you begin to dig, some things which have accumulated over the years come to light, and it becomes obvious that they are not by any means perfect.
Our job is to improve that branch just as fast as we can and to recognize that we have a number of people who have worked hard and diligently for many years and are doing an excellent job. It is important that the quality of the work they do not be besmirched. It is important that Canadians have faith in the processes that go on.
I will conclude with one observation: One of the grave problems that has accumulated over time is that the whole process of the branch and this particular part of the branch has indeed been a bit of a black box. There is no really good public window looking in on how the decisions are made and no opportunity for outside comment at the end of the process before a product is given approval for sale in Canada. This is a real problem. It is a problem that we face not just in Canada, but one faced around the world.
We will be coming back to Parliament with some questions about how, as part of a regular process, there can be a window to give people the confidence that things have been conducted well. This is not as easy as it sounds, because we are always dealing with proprietary information and many other things. As you know, we are conducting a major set of hearings, concluding in Toronto today, as a first round in trying to see how we can move this process forward.
I am happy to answer any questions, senators, to the best of my ability. Having not been here long, I trust you will appreciate that I can give you the best answer I can. It may not be complete, and it will take some time.
Senator Whelan: My question is to the Deputy Minister of Health, Mr. Dodge. You say you have not been with the department very long as deputy minister.
Mr. Dodge: That is correct, senator.
Senator Whelan: Your background is finance; it is not science.
Mr. Dodge: My background is as a professional economist. I spent 14 years prior to this in the Department of Finance. The last year I spent largely with the medical faculty at UBC.
Senator Whelan: Based on what this committee has uncovered up to this point, I feel we must discuss two issues. First, what are the effects of and what is the value of the use of rBST in Canada? Second, we must evaluate the competency and integrity of Health Canada and its drug approval process.
For instance, we had highly educated, skilled scientists testify before this committee last week. They testified under oath that they had been pressured and coerced to pass drugs of questionable safety at Health Canada. How do you respond to this?
Mr. Dodge: As I said in my opening statement, senator, these allegations, if founded, are extraordinarily serious. There can be absolutely no question of coercion. If you are asking me if I can personally assure you that there was no coercion, no, I cannot. We do have processes in place to deal with those issues. Obviously, as a deputy minister, I am extraordinarily concerned about that allegation, and I am taking steps to get to the bottom of the matter.
Senator Whelan: Why would the rBST review team we heard last week charge that there are "very serious problems of secrecy, conspiracy and things of that nature" in the department?
Mr. Dodge: Senator, as we all know, this has not been a part of the operation of the department which, over a number of years, has been, to say the least, a terribly happy shop to work in.
Approximately a year ago, under Mr. Rock's leadership, a process was established to renew and rebuild the Health Protection Branch. Part of that process is to ensure that the Bureau of Veterinary Drugs, and all bureaus in the branch, are capable of meeting the requirements placed upon them by the Canadian public, not only now, but looking into the next century.
Action has been taken. Dr. Losos was brought in to head the branch a year ago. Dr. Lachance was brought in last April, I believe, to head this particular bureau. Ian Shugart joined about a year ago to work on the whole process. I was asked to come back three months ago to drive this forward. There is a clear recognition that not everything is right.
Senator Whelan: When the rBST review team filed grievances with their union, the Professional Institute of the Public Service of Canada, why was it not even heard?
Mr. Dodge: I am not aware that that is in fact the case, senator. Perhaps I could ask Mr. Nymark, who is the most senior person in the department who hears grievances, to comment on that.
Mr. Alan Nymark, Associate Deputy Minister, Health Canada: I think the grievance you have in mind led to the final hearing process last December. At that time, the grievers had an opportunity to make both oral and written comments. The grievers chose not to appear in person but to do so in writing, and it was heard on that basis.
Senator Whelan: I have one further question on that issue, based on testimony given under oath. Why were the scientists gagged? Surely this is not a normal procedure.
Mr. Dodge: With due respect, senator, the word "gagged" is yours.
The normal procedure in any department, as you well know, is that departmental spokesmen are appointed for purposes of the media. That is the normal procedure.
Internally -- and this is an extraordinarily important point -- good science must have an atmosphere of free discussion and free debate in order to survive. That is critical. It does not matter whether it is veterinary science, human science or economic science. It is critical that we have that freedom within the department and within any department.
When doubts are raised, and it is appropriate that individual scientists and reviewers do raise this when there are serious doubts, then outside panels and experts are brought in. That is the case in this situation, as far as I understand.
Senator Whelan: I know you are aware of it, but I will gently remind you that I was a minister for nearly 11 years. I do not remember any of that procedure taking place, and we had an open door policy.
Tell me this: If I write the minister a letter and it goes down to the director of some branch for an answer, how many people does it go through before it gets back to the minister, if it gets back to the minister?
Mr. Dodge: Too many.
Senator Whelan: That is what I said, too. In the department I was with, it goes through seven people before it goes to the minister. Do you not think, as a big wheel in the Department of Finance, that that is a hell of a waste of money, going through seven or eight people with a letter before it is approved?
Mr. Dodge: Obviously, from my previous answer, departmental procedures tend to have too many people. One of the things we are doing is trying to cut that down. The answer to your question is "yes." Three is probably reasonable.
Senator Whelan: I was shocked to hear some of the things that were said about files, such as one person having the key to the files on rBST and that that was the only file that was locked up. Could you explain how and why the files belonging to Dr. Margaret Haydon were stolen?
Mr. Dodge: No, I cannot explain that, senator. My understanding is that following that problem, there was an RCMP investigation. If you would like, perhaps I could ask Dr. Losos to comment. I cannot go further than that. I just do not know.
Senator Whelan: Would that not be reported to you? Would you not be aware of that? As Deputy Minister, you are supposed to know everything that goes on.
Mr. Dodge: I am glad you used the words "supposed to," senator. This took place, as I understand it, in 1994. At that time, an RCMP investigation was ordered. As I said, that much I do know. If you would like, I could ask Dr. Losos to comment on what happened in 1994 following that incident.
Dr. J.Z. Losos, Assistant Deputy Minister, Health Protection Branch, Health Canada: Senator, Dr. Haydon reported the alleged incident. That was immediately shipped over to security. Security called in the RCMP. The RCMP conducted intensive interviews of all the participants. They did fingerprints of all of the offices and the like. They found that there was no substantial evidence of a break-in and closed the file.
Senator Whelan: If my memory is correct, Dr. Haydon said that one of your officials went to her house when she was on sick leave and picked up the files, and she never saw them again.
Mr. Losos: This may have been part of the investigation, senator. I do not know the details of that, but certainly the RCMP were in total control of that investigation and closed the file.
Senator Whelan: I go back to the Deputy Minister, then. How can you explain that the files pertaining to rBST were kept locked up and that only Dr. Ian MacDonald and Dr. George Paterson had access to them? Surely this is not normal. Evidence was given that, out of 20 different drugs or hormones being examined, this was the only one that was kept locked up. Was there something really secretive about rBST?
Mr. Dodge: Senator, you yourself just raised the issue of theft and security in the department. On extraordinarily sensitive files, of which rBST is one, the normal procedure is that heightened security measures are used. My understanding is that this would normally apply to as many as three or four files across the department at any one time. It is not the 95 per cent procedure, but this is not one of the 95 per cent of normal reviews that are taking place.
Senator Spivak: Mr. Dodge, thank you for attending. I understand it was on short notice, and I am glad to have you here.
Mr. Dodge: I would rather be with you, senator, than with the Chamber of Commerce, which is where I was supposed to be.
Senator Spivak: Senator Whelan got down to some basic issues, and I would like to do the same, if I may. I know that you are new to the department, but a very important, fundamental value is at stake here.
In mid-September, just recently, sworn testimony before the Labour Board meetings quoted the Director of Veterinary Drugs as telling his staff very clearly that industry is Health Canada's client. He said they are now working in a new environment in government, serving industry. They are the clients. He also told the scientists that if they did not cooperate, according to his testimony, they could be sent to another department and never heard from again.
I am talking about the general system of values here.
It is quite clear, according to the gap analysis, that you have spoken about rBST being an unusual case. Why? The usual evaluation procedures were not followed in the case of submissions dealing with rBST.
I wish to refer, because I think that is the heart of the matter, to the gap analysis. It says that it is the responsibility of the Health Safety Division and the BVD to determine that rBST poses no hazard to human health as assessed under the exigencies of the Food and Drug Act Regulations. The standard requirement for any drug is a data package which includes standard requirements which include acute, subacute, chronic studies, two generation, reproduction studies, and other special studies. The Nutrilac submission did not contain the usual chronic toxicity, carcinogenicity or reproduction development toxicity studies. The whole thing was based on a 90-day rat study which was misreported.
The question is, if, according to the Food and Drugs Act, the prime concern is the safety of Canadians, and the minister says that that is all he cares about, why then would you not go back to the point that it is the public that is the client, order these long-term studies, and get this thing completely over with?
There is a suspicion here that since 70 per cent of funding is by industry, that you are trying to be nice to industry. Therefore, perhaps we are not getting, as a Canadian public, what we should be getting in terms of process.
Mr. Dodge: Senator, I will leave the scientific part of your question to the people who know the science. I will deal with the philosophy values and process questions, if that is fair.
The job of the department, and we must be extraordinarily clear about it, is to protect the health and safety of Canadians. That is the job. Our client is every one of the 30 million Canadians out there who eat food, consume drugs, and use toys or other products. Our job, to the best of our ability, is to ensure that the food or drugs they take or the goods they use are indeed as safe as we know how to make them given current science. Our job is also to assure, to the best of our ability, that the air the people breathe and the water they drink is safe. That is our job, and there should be absolutely no confusion about that being our job. That is our sole job.
Senator Spivak: Dr. Lachance will be corrected in terms of who he thinks is the client?
Mr. Dodge: Let me carry on. In performing that job, there are enormous pressures on the department from all sides. Obviously, if we take longer to look at the approval of a particular drug or product, Canadians out there may be suffering from the lack of it.
Senator, you asked a general question. One of the pressures that is undoubtedly on all of us as employees in the department is to carry out our business as expeditiously as we can, against the philosophy I initially enunciated. That is a real pressure on our staff, many of whom work extraordinarily long hours in order to carry out their duties.
I happen to have been on the other side, since I use drugs for my cattle. When products are available elsewhere in the world, there are pressures from users to make them available here. Of course there are pressures from industry, which has spent time and money developing a product to get it to market as quickly as possible. There are an enormous number of pressures.
The fundamental job of the department -- and we should be absolutely clear about this -- is to protect the health and safety of Canadians, recognizing there are all these pressures out there.
Senator Spivak: If I could switch the subject slightly, there have been allegations of shredding documents in the department in the last few days. Do you know about this? What has been shredded? Will we get none of the information that is supposed to be coming to us? I hope it is not being shredded, but I would like your assurance.
We also know from the department's memo of October 20 that Monsanto's lawyers in St. Louis have contacted Health Canada. Their concern is that in responding to this committee and others, the department may disclose more information than we had last week.
If I had time in this round of questions, which I am sure I do not, I would like to go through the access to information process and the minister's override, which seems to be misunderstood from the top down. Of course, public interest can always override any commercial interest.
What can you tell us about the shredding, about the memos, and whether we will get the rest of the information we have requested?
Mr. Dodge: Let me start with the issue of shredding. This is an extraordinarily serious allegation. I heard of it at noon yesterday. By one o'clock, Mr. Leadbeater was in my office. I said to Mr. Leadbeater, who is the deputy commissioner, "Look, you come in and you run your process as fast as you can possibly run it. This is absolutely unacceptable behaviour if, indeed, it did take place."
Right away, I ordered that no document of any sort, however tangentially related to the rBST file, be either disposed of or destroyed and that no document within the Bureau of Veterinary Drugs, regardless of subject matter, be disposed of or destroyed. I put my personal assistant in my own office at the disposition of the information commissioner so that his work could proceed as quickly as possible.
It is very important that the information commissioner be given full access and that he move as quickly as possible. These are very serious allegations. There is no way that any document of that nature ought to be disposed of while this is going on.
It may turn out that newspaper clippings and a whole bunch of other stuff got thrown in the machine. I do not know. Quite frankly, it is important that the information commissioner go at it so that there is no taint of any sort. He is a neutral party. He carries out his job, and that is a very important process. That process is now running and will run just as fast as the information commissioner in my office can make it run.
Your second question related tangentially to lawyers. Sometimes one thinks that maybe we are not in the health business at all, that we are in the lawyer business in our department, given the number of cases that are going on. It does point to a very difficult issue with which we are collectively grappling in this country, and that is, with respect to the development of drugs, essentially we rely on the protection provided to intellectual property through patents to provide the stimulus for research which has benefited us all. As part of that, we grant patent protection for a period of time. During that period of time, the proponent must come in and secure a notice of compliance in order to sell their product.
The information they supply to us and the FDA and authorities in other countries is proprietary information. That makes life extraordinarily difficult. It is not like science back at the university where you are dealing with everything on the public record, in essence. You are dealing with proprietary information that has been put together. The great difficulty we all have is how, given the background against which we are working, we provide a light into the system which does not compromise that proprietary information.
If it is compromised in Canada and if developers of these products feel that it is compromised in Canada, then unfortunately they will not bother to come here because we are 2 per cent of the world market. Citizens and farmers will not have available those particular products which are available in other countries.
This is an extraordinarily difficult problem. How do we deal with this, and how do we walk down that road? It means that inevitably, in an approval process dealing with proprietary information such as that run by Health Canada, there is not as much light on things as might otherwise be the case, because all the reviewers must agree to abide by the rules.
Senator Spivak: With great respect, in this particular case there are so many egregious errors that you cannot fall back on the proprietary and commercial distinction. I think that evidence is clear if you review it carefully.
Given all of the gaps, the errors, the lack of reliance on raw data, and summaries which were misreported, are you now prepared to allow the long-term studies for rBST, which are normally done under any drug, so that we can cease this and go after protecting the health of the public? Are you prepared to do that? Are you prepared to state that that is what you will do?
Mr. Dodge: Senator, I must confess that I do not quite understand that question. Perhaps it is an ignorance of what you mean by "long-term studies."
Senator Spivak: Mr. Dodge, normally, as is in the gaps analysis, a drug like this would have long-term studies. For example, instead of a 90-day study of rats, it might be longer. There are all kinds of studies. Things should be studied which were not studied, such as the derangement of the immune system and levels of IGF-1. That was not done.
Are you prepared to let the proper process be followed so that rBST will be deemed safe? No one would be happier than I if it is indeed deemed safe. I do not want this drug, but if it is safe, what can I do?
Mr. Dodge: Senator, as you are aware, at the moment we are awaiting the final reports of the two expert panels. You will be hearing from the heads of those panels later this morning.
I take it, though, that you are raising a slightly different question. We are dealing here with a genetically engineered product, the first of a flood of many which we will face over the years ahead. What you are raising is the question: Are we really sure that in the years ahead there is a likelihood that this product will have effects that will not show up?
Senator Spivak: No, it is that the process was flawed. Will we now have the proper process? That is the point.
Mr. Dodge: Excuse me, senator. The general nature of the process of the investigation internally, that is, the use of internal panels and external panels, is the normal review process. What is abnormal this time is that there are enough uncertainties around this particular product that this has taken a long time. It will not be approved -- will not be approved -- until such time as the evidence is clear that it is safe for humans. That evidence is not yet here. The drug is not approved.
The Chairman: The dairy producers asked that the Auditor General look into this situation. Has he begun his inquiry, or are you aware of that?
Mr. Dodge: I am very much aware of that. I had a good meeting with the dairy people last week, senator. The Auditor General has played a very important role over the last three or four years in looking at various parts of the Health Protection Branch operation and continues to be a very important player in the game.
As we move through the winter and the spring, we will be looking to the Auditor General to provide us with a significant amount of comment as we go through with structures to improve the science and the quality of protection for Canadians. The Auditor General is an important player in this process.
Senator Fairbairn: I should like to make some observations. You come from, if you will, the very pinnacle of the department. These are extraordinary hearings on a subject about which most Canadians would not even have been aware. One of the reasons for this is that there is an anxiety in Canada right now in a variety of areas, not just the health area. Public confidence in their institutions, their systems and their own self-preservation is a concern.
You have talked about how we will be flooded with different situations such as this in the drug area. This one is special because it affects probably the most fundamental nutrient in everyday life in our country at every age, namely, milk. I believe that is one of the reasons for a sustaining interest on the part of the public in their concern about confidence.
Last week, we heard from representatives of the National Dairy Council of Canada and the Dairy Farmers of Canada. They told us that this country has an extraordinary reputation for its product. If that reputation is lost, for whatever reason, I think everyone in this room knows that it will be well nigh impossible to bring it back. To ordinary Canadians -- not people who sit on a Senate committee -- this is of fundamental importance.
That brings me to another reasons for this issue getting a special spotlight, and that is that our confidence in our country has been shaken. It has been shaken through the problems with the blood supply system and through ongoing situations such as those at the Sick Children's Hospital in Toronto which involve research on children where blockages are being put in the way of the doctor who had the courage to stand up and say that there is something wrong.
All of this has created anxiety. The drug rBST has now become a symbol of that anxiety.
I should like to go beyond what Senator Spivak was asking in terms of the mandate of the Health Protection Branch. You have been very clear that it is public safety. You have been adamant that it is public safety, as has the minister.
Last week, we heard testimony that in the view of some within the department -- and clearly some who have a managerial significance -- the impression has been given within the department that the first client is industry and money, and that the second is safety. You do not agree with that, and you do not want that to be the case. However, if this attitude exists within the department and the Health Protection Branch, I want to know what you and others in the department intend to do to completely dispel this impression. As public policy makers, the notion that health safety is taking second place to money and industry is unacceptable.
Will one of the benefits of this committee hearing be that steps will be taken within the department to ensure that that is not its mandate?
Mr. Dodge: Senator, absolutely. That is the benefit of a process like this. It raises this issue and makes it absolutely clear to everyone, including our employees.
My own experience in the department, and admittedly it is short, is that we have a group of employees who are extraordinarily committed to the health and safety of Canadians. While some people may express themselves somewhat differently, I have been struck by the degree of commitment of the employees in the department. They are amazingly committed.
Going back to what I said earlier to Senator Spivak, the problem arises in that we also have an obligation to proceed on things as expeditiously as possible. There is pressure on every reviewer and manager to get on with the job and to work extra hours to ensure that the reviews are done in a timely fashion.
That pressure has been growing. The department and the number of employees have not been growing. The number of things coming through our front door has been growing. I must address that as a manager. That is a real pressure. We do have an obligation to proceed expeditiously.
Let us be extraordinarily clear around this table that the mandate of the department is the health and safety of Canadians. My job is to ensure the department carries out that mandate.
I agree with you, senator, that the confidence of Canadians in Health Canada, as well as in a number of institutions in our health system and in the country, has been shaken. That is why I came back to Ottawa to take this job, because it is extraordinarily important that we try to rebuild this confidence. Whether I can make a contribution to doing that rebuilding, time will tell. Certainly that is my aim.
Senator Fairbairn: On the question of the reviews, you indicated that your regular process for review, in an area such as this where questions and concerns have been raised, has prevailed. There have been internal reviews, and now there are two external reviews being conducted. You have also made the point that reviewing and pronouncing on the safety of drugs in most cases involves pressure because people are suffering and perhaps would have value from the drugs under consideration.
In this case, that is not so. You spoke about being a cattle producer. The pictures that have been drawn of some of the effects on the animals, and this is by one of the external panel reviews, cause anyone who is interested great concern. This raises other questions.
We have a hormone or growth substance. We have the Dairy Council of Canada saying they are not drawing any conclusions but are counting on your conclusion. They also added that if your conclusion caused the destruction of public confidence, they would be looking for compensation from the government. I am sure you do not want that.
Even more strongly, the representative of the dairy farmers said they do not want any part of it. Both groups said that there are other ways to increase production, if increasing production is the goal, without the use of rBST. Therefore, there is not that urgency.
One of the concerns we have heard is that people were doing reviews and studies on top of someone else's summary and conclusions. There was a lack of opportunity to revisit some of these concerns based on a study of raw data. Can we be assured that, if that is required to carry this to its ultimate end, there is a commitment on behalf of the government that the time and the procedure will be available to make that possible?
Mr. Dodge: Absolutely, senator. The rBST submission came in approximately eight or nine years ago. We may have to go for two, three or four more years before we are all comfortable that we know either enough to say that it will never, ever be approved or that it is safe.
All the material that is required will be demanded of the company. All the material will be made available to the panels. Time will be provided for the panels and any further subsequent investigation as a result of what the panels report to us.
Senator Fairbairn: Will the raw data also be provided, if that is what is required?
Mr. Dodge: If that is what is required, senator, absolutely.
Senator Stratton: Mr. Dodge, thank you for appearing. This issue has become very emotional. It reminds one of a previous issue about the radiation of food, with which we are all familiar. I am not certain to this date whether or not the radiation of food is safe; it has not been made clear.
You said you were addressing the process by which you will handle these new biotech ideas that will be coming across your plate in the future in ever increasing numbers. The last thing we want, and I am sure the last thing you want, is an ongoing process where every time a new product goes for approval we have this kind of hearing. This is really not the way to go.
Can you describe to us the process or the evaluation that you are now undertaking, what the likely outcome will be, and a time-frame for your approach to these new chemicals and drugs?
Mr. Dodge: I will give you the general response, and then I would ask Mr. Losos and Mr. Shugart to fill in some of the details.
We must ensure that Health Canada has the scientific capacity to be able to provide data analysis independent of what industry brings to us. These are new areas. There is a shortage throughout the world of the brainpower to do the job. However, we must build a capacity to deal with that. That is the job that we are now undertaking.
Rather than give you false information, I will turn to Dr. Losos.
Mr. Losos: Senator, that is an excellent question. The company is required to give us certain types of information. We go through it with our evaluators. They are expert in their field, and they go through everything from A to Z on the submission, including whether it is complete and whether the science is properly carried out.
If there is any question on the science, we may set up an internal panel of scientists, internal to the bureau or people from outside the bureau, to give it another go. If that does not resolve the situation, we can sometimes set up an internal and external panel of more formal proportions, all the way to the external panels you will see before you shortly.
Also, we will deal with the international community where the best science or other science is being carried out. Science is an always-evolving process. We keep our weather eye on what the international community is doing, and we have an international expert to explain that to the panel today.
As well, science continues to evolve. We keep our eye on the literature. rBST has been evaluated for nine years, but we are not evaluating with the science of nine years ago. We constantly update our science and review the submission accordingly.
In a nutshell, that is the type of procedure and mechanisms we have to ensure that absolutely everything is brought to bear.
Senator Stratton: You describe the scientific approach you are taking. I am more concerned, as are all Canadians, that it may be a perfectly good drug that is coming forward. It may be a perfectly good process that is coming forward. However, there is disagreement. Being a bit familiar with the scientific community, it is ever thus.
My concern is that I did not hear anything about educating the public as to these issues. You know you will have controversy on drugs, especially these new ones coming down. How will we possibly deal with it if we do not at least try to explain to Canadians what is going on with this new technology that is coming down the track at us faster and faster?
Mr. Dodge: Senator, perhaps I could ask Ian Shugart to answer because this is one of the key issues that has been in front of us in thinking about the renewal of the branch. I am glad you raised this question.
Mr. Ian Shugart, Visiting Assistant Deputy Minister, HPB Transition, Health Canada: Senator, I can only echo what Senator Spivak said: "This may prove to be safe. I hope so, but even so, I do not want it."
The issue that you have touched on speaks to the reality that Canadians will always want to be satisfied that the scientific review is there. However, in certain products, they will still want to exercise choice about whether they want to consume that product. That is particularly important in something which is as pervasive a product as milk. Senator Fairbairn mentioned that earlier.
One option that is now available is providing consumers with information about the nature of a particular product, assuming, again, that the science has been addressed. We must never be in the position of replacing market concerns with the scientific scrutiny of a product which may be unsafe; however, having satisfied that threshold, it may be in the future that part of the process will be to provide additional information so that consumers can exercise an informed choice.
We do not have the detailed answers at this point, but that is one of the issues with which we have been seized. We have been trying to work through it. Indeed, some of the discussions that we have been having publicly, including with our own staff, are about attempts to put the process on that general principle.
Senator Stratton: Do you have a timeframe in mind for this?
Mr. Dodge: Senator, we would hope that, following this recent round of consultations, we sort of go back to the drawing boards. We will then be having discussions at the House committee. We will then prepare some sort of paper which we will bring forward with a design of how we proceed from here and with an indication of the legislative changes that will probably be required. That includes dealing with the issue which Senator Spivak raised earlier: How can we provide some way for the public to look in on the process?
Following yet another round of consultations, we will come back with draft legislation. That process takes roughly 18 months.
Senator Stratton: As you know, five scientists appeared last week before this committee, three of whom took an oath. It took a lot of courage to give that testimony. I would like to have your assurance in front of this committee that those people will be dealt with fairly in the future. The last thing this committee wants to hear is that one of them ends up in Timbuktu, for lack of a better word. I do not want to offend anyone in Canada by naming a city such as Winnipeg. Therefore, I would like to have your assurance.
I have told them -- and I thank them for being here again today -- that if they do have a problem, to please come to us. If we cannot get assurance or reassurance from the health department, do I have your assurance?
Mr. Dodge: Senator, the allegations that are being made are obviously being examined through due process. That due process is extraordinarily important. Every employee deserves the protection of that due process.
These employees and every other employee of the Department of Health -- indeed, I would hope, of the Government of Canada -- ought to be afforded all those protections of due process.
Senator Sparrow: Mr. Chairman, and to the witnesses, I would think that those people who are opposed to the use of the drug will find great comfort in these hearings. I would believe that the research will now go nowhere, that the department is running scared, and that they will not approve the product in the future in any way. That is disturbing, but I would make that observation. I do believe the department appears to be running scared.
The last comment was that the public service deserves the protection of the department. Have there been any memos or indications from the minister or the deputy minister level indicating that there is a change in attitude in the department? Will these scientists and the other staff in fact have greater freedom to do their research without records being locked up?
My concern is not only with this product but with what may be happening in other aspects of research that are very important to the health of Canadians.
I would also like some indication of whether there is something in the synthetic rBST that is secretive or that would jeopardize the manufacturer or distributor by having that information become knowledge. We continue to hear from not only this department but others about the competitive aspect, the commercial aspect, and how we must protect that. The government department seems to always run behind that and say that we must protect the competitive aspect.
From some of the other senators' questions, I would say the protection is for the Canadian people and not just for the corporations.
I ask you again: Is there something in rBST that the general public should not know about?
Mr. Dodge: There are many questions there, senator. The scientific questions I will leave to the scientists to answer. They can do it far better than I can.
I will deal with three issues which you have raised: that of the department running scared; that of records being locked up in secrecy; and that of competition.
Senator, the department is not running scared. The department has a duty to exercise its role to protect the health and safety of Canadians. Every employee of the department has that duty. Let us be very clear. Exercising that duty is not running scared. Exercising that duty is what we are all paid to do. We will do it to the best of our ability. Any implication that somehow there are scare tactics will warp the judgment of the employees of the department is absolutely unwarranted.
Senator Sparrow: We had sworn evidence before this committee that certain things were happening and that it was unusual. That issue must be addressed. The issue is that there was some direction given to these people within your department that they were to clam up so that they were afraid to come before this committee without having sworn testimony.
Mr. Dodge: Senator, I cannot speak for the individuals. What I can tell you is that for any committee of the Senate or the House of Commons that wants employees of my department or wants me to come and testify, we will be there. The instruction to all employees is just that, under all circumstances. We are the servants of the people of Canada, you are the representatives of the people of Canada, and we owe it to you to come before you and talk to you. I cannot understand that people would say that they are afraid to go and talk in front of the Senate committee. It is our obligation as public servants to do so. Perhaps some people did not understand that, but that is the case.
You asked about records being locked up and secrecy and so on. There are, as I said earlier, always a few extraordinarily sensitive files. It is normal, prudent management, with respect to sensitive files, to take security procedures that may go beyond the normal security procedures. Obviously, any manager hesitates to take those procedures because it is just plain inconvenient for staff when they have to submit to it. We do not use it any more than we have to.
On the other hand, and you raised this earlier, there was a problem apparently back in 1994 where some records went missing. Surely it is the obligation of the department, then, to ensure that that does not happen again. It is very inconvenient. As a researcher, I know how inconvenient it is. However, it is also important that everyone have confidence that appropriate security measures are being taken.
Finally, let me address the competitive aspect. This is fundamentally a very difficult issue. It is not driven so much by the corporations. We have set up in the western world -- and we are part of that system -- a system to try to drive research that does not require all that research to be done by public money. We use the patent mechanism to do it. That generates, unfortunately, proprietary material. If we, in Canada, say, "No, all or most of that material that is submitted becomes a matter of public knowledge," then unfortunately Canada will be the very last place that owners of that intellectual property will come to put their product on the market.
Normally, as I am sure you are aware, senator, the problem that is brought to our attention is that the farmers of Canada cannot get access to herbicides, pesticides, or veterinary drugs as rapidly as their competitors south of the border. Normally, the pressure is in the other direction.
This is not a cut-and-dried, easy issue to handle. It is one that we struggle with, and that you as legislators must struggle with, all the time. It is a difficult balance.
In this particular case, though, we have a new class of drug being brought to market, a genetically engineered drug. I think personally -- senators may choose to disagree <#0107> that in this case it is extraordinarily important that every possible step be taken to ensure the health and safety of Canadians, even if it means a delay, a very long delay, in dealing with this.
Senator Sparrow: The question is: Is there an ingredient in that synthetic product that the public should not know about or that is being protected for commercial interests?
Mr. Dodge: Senator, I cannot answer that. I would like you to put that question to the scientists. Can we come back to that rather than deal with it now?
Senator Sparrow: Come back to it when?
Mr. Dodge: We have Dr. Losos and a number of other scientists here, and that is really a question that should go to them rather than to me. I am not the guy you want to hear from on that.
Senator Sparrow: Has the research now slowed down or come to a standstill since this issue has come forward, or is it still proceeding as it normally would have or has been? Are the scientists who have appeared before us, and others, in a hold on the research now?
Mr. Dodge: I would have thought that what we have is an enormous amount of work going on on this, far beyond what would normally have been done, but perhaps Dr. Losos could comment.
Mr. Losos: Senator, the work is continuing internationally and nationally, in academic centres. When the Food and Drug Administration approved this, they required a number of longitudinal, long-term studies to continue. The science never stops on this.
Senator Sparrow: I was asking about the science within your department, sir. I was not talking world-wide. I am sure we are not affecting the worldwide aspect of research in this regard.
Mr. Losos: We are involved in that through the experts you will see in front of you in a few minutes. The analysis does continue in the department. That is true of every drug. Once a notice of compliance is given to any medication -- calcium channel blockers, antibiotics, whatever -- the monitoring systems continue in place because data may change. The experience of a medication in the huge population of a country, or the planet, for that matter, always affects whether a drug stays on the market or whether its labeling stays the same. Human experience changes with these medications. Research is an ongoing, constant thing. It is never a one-off situation.
Senator Sparrow: No directives have been issued from the department to now hold particular actions within your scientific research?
Mr. Losos: Absolutely not, senator.
The Chairman: Before I go to Senator Ghitter, I have a question that comes from my agricultural background as a farmer. There are some excellent sprays available, and we know the importance of the developments that have come through scientific research by companies like Monsanto and others. My question is one of balance. There have been some sprays that have been taken off the market that should not have been, and there are some about which we have a concern.
It seems that the political implications or the hype that is raised sometimes makes the decision for us. I am wondering about balance. I am not under any illusion that it must be very difficult for the scientific community to come to a balance, given all the public implications and the media hype and so on. I suppose there is no quick answer to that. We need to be fair to the companies that do great work. Each one of us in this room benefits from a standard of living that we would not have if it were not for some of these scientific developments. I know that as a farmer. I would go as far as to say that if you removed many of the advantages that we have because of scientific research, probably half of the world would starve. I think Senator Whelan might question that.
Senator Whelan: I will answer it for you.
The Chairman: My question is one of balance. How do we get a balance? We see advancements in our scientific community as knowledge increases, and we are seeing the benefits of their research. There is no quick answer.
Mr. Dodge: If I could answer that definitively, I would deserve the Order of Canada.
There are two issues of balance here. One is the scientific implications for human and animal health. That is the job of our department. We may have to make some changes to the way we go about it, but that is our job.
We then go beyond that. Some of these new developments have very important ethical, social, and economic implications. The Health Protection Branch is not the place where economic and social implications can be brought to bear.
We then come to another question that will have to put back before Parliament as the work that Ian Shugart is heading in terms of the renewal of the Health Protection Branch moves forward. How can economic, social, and ethical interests be brought to bear in the process? One does not want the science and the objective impacts on human and animal health to be coloured by those considerations. One wants clean advice as to the safety aspects, and then one wants to be able to deal with some of these things outside of that with respect to the other issues.
That is not a business for us; that is a business for Parliament. It is an extraordinarily difficult piece of business but one, especially as we enter into the world of genetic engineering, with which Parliament will have to struggle. It is not an easy issue by any stretch of the imagination.
The Chairman: In the future, we will be looking at another issue. In other words, do not tell me what happened, but tell me what will happen. The whole dairy industry is very much protected by the marketing board concept, which tells us at this point in time that we do not need to compete with the Americans or we do not need to compete economically because of the protections that are in place. I see that changing over time, and there may be a change of position on this issue because of economic reality. Have you given any thought to that?
Mr. Dodge: Senator, both Mr. Nymark and I, in former capacities, spent a lot of time worrying about those issues. I do not think it is appropriate for either of us in our capacities as deputy and associate ministers of health to deal with that.
The Chairman: In other words, that is a political issue, as you would frame it.
Mr. Dodge: It is not just political. There are some real economic analytic impacts. I would very much hesitate to speak on those issues in my capacity as deputy minister. However, they are extraordinarily important issues with which we have been struggling for the last 20 years and will continue to struggle with for the next 20 years.
Senator Whelan: My colleague, the chairman, makes a comment about supply management. I hope to God he makes a comparison to what the drug companies have on supply management. I am thinking of Viagra and that type of thing. What will one pay for one little pill? Are you investigating that and the costs, the economics, and the social problems? If not, you should.
Mr. Dodge: Viagra is not approved for sale in Canada at the moment.
Senator Ghitter: Mr. Dodge, you are a distinguished public servant who is well known to us and who has served Canada very well in many ways over a number of years. Your presence here today in your new position sends out two messages to me, one of them favourable, one of them not. The favourable message is that the government is taking the situation seriously by bringing you in to take on this job. The one that is not so acceptable, if that is the word, is that bringing in someone of your calibre is somewhat of a damage control situation in that there are problems in the department. That becomes very obvious as we sit and listen to what has occurred.
You have used the words "extraordinary" and "extraordinarily" a number of times today because this is an extraordinary circumstance. It is rather clandestine. We could bring in Perry Mason, I suppose. In the United States, they give "gates" to everything, such as Watergate. We have Peppergate, and now we have Cowgate. Nevertheless, this is a serious situation.
This relates to the frustration I feel and I am sure my colleagues feel, given the questions they have asked, as to the lack of confidence in the department. In my opinion, that is the most important aspect of everything I have heard. Unless you come clean with what happened and explain to Canadians what has happened, you will never rebuild their confidence. I do not feel we know what happened. I do not believe that answers have been forthcoming from the department as to what happened. I think there is an obligation on your department to tell Canadians what happened over those years with these activities. It gives me no comfort that Sergeant Fiegenwald was the RCMP officer. We know him from the Airbus situation. That gives me no confidence that the RCMP has really conducted the investigation that has been suggested. I would like your comments in that regard.
This also affects decisions that were made by the department on other products. If this kind of thing was going on in the department, it puts a cloud over all of the past decisions of the department in dealing with products. We can ask, "If this happened with respect to this particular product, what about the other decisions? Were they industry motivated and not health motivated?"
I think there is an immense obligation on your department at this time to get to the bottom of this and tell Canadians what happened, and I do not feel that you have done that for this committee at this point in time.
Mr. Dodge: Cow gates are things that I use to keep the cattle in and off the road.
You have put your finger on the fundamental issue, as did Senator Fairbairn. Canadians must have confidence that the work of the Health Protection Branch is done well, fairly, without bias, and expeditiously. You are right that these allegations of a very serious nature do cast a cloud over the department, and not only in the confidence of Canadians, but they cast a cloud over everyone who works in the department and goes about doing their job in an excellent way.
Therefore, it is absolutely incumbent on us -- I agree with you -- to get to the bottom of these allegations, to the extent that they are substantiated, and to make corrections to ensure that these particular allegations will not be made again, or that once they are founded, the circumstances will not pertain.
That is exactly what we are striving to do right at the moment. However, it is very important here that due process be given and that we use that process appropriately to get to the bottom of it. It is not helpful if I were to go in on my own hook with my boots on and go rummaging through and come back to this committee and tell you that I found this because I am the manager of the operation and it would be seen that I have a party pre-position. I will do that -- in fact, I am doing that -- but it is also important that the good processes which exist to deal with these things and to protect our employees, such as the grievance procedure, continue and that they continue to their conclusion. There should be no chance that these processes are tainted by me going in and taking what might be regarded in the end as heavy-handed actions.
We do not have a lot of time. I take your point that we must move expeditiously. We must be able to come back to this committee, to the standing committee on health, and to Canadians in general and be able to say, "These are the results of these processes. These were the allegations that were substantiated, and this is what we have done to deal with that. These are the allegations which were not substantiated and which you should not worry about."
That is what is incumbent upon me. That is why, for example, when this issue of document destruction came to my attention, I moved so quickly and am according 100 per cent or more support to the information commissioner to move quickly to get his job done.
These are very serious allegations. It is my job not only to ensure that they are cleared up but also to ensure that we use due process so that you and all Canadians can have confidence in the results in the end.
Senator Ghitter: I only add that I urge you to do so. Some of these due processes are such that the public never knows about them because they are always undertaken behind closed doors. It would not be in your interest to conduct them behind closed doors to the extent that you can open those doors. These issues are too important and too profound to do so in this case. They affect Canadians too greatly for this process to be hidden in some way.
Mr. Dodge: Absolutely.
The Chairman: One of the assets of this Senate committee is that we want to take a good look at this without the political implications that may arise in other committees. As chairman, I may have different views from other people around the table, but this is an open committee. This is something that Canada needs in terms of dealing with situations that are difficult, such as the one that is before us. Thank you for taking the time to make that comment.
Senator Whelan: We both have an agricultural background, but we have different views on how agriculture should be served, for example, on some of the things that were mentioned here about supply management and so on.
I used to deal many former employees of the Department of Finance. I used to meet my colleague, the Minister of Finance, in the morning. I never treated him like the Minister of Health but always said, "Good morning, God." We went on from there.
As Senator Ghitter has said and as you have agreed, you must expedite this. However, studies were done in 1980 on rBST. Dr. Haydon was doing work on it in 1988, if I remember correctly. You have had this for a long time in the department. I am alarmed at that.
The thing that all of us agree on here is the lack of communication in your department. Dr. Losos, they said that you are almost next door to them, yet you did not even talk to these people. It is astounding and shocking to an old farmer, a politician for 39 years and a new senator, that that kind of thing goes on within a department. I cannot believe that. Perhaps the minister is not informed that this is happening. Maybe he does not receive letters, just as Gorbachev never received letters.
In general, society feels -- Senator Ghitter has said this also -- that we have taken too long with this thing. Senator Sparrow mentioned the feeling of suspicion and fear that exists in how we are approving these drugs. That evidence was put forward. You are the manager of your department. Perhaps this Senate committee should follow your suggestion and take about six months and go through the whole department and talk to all these people to find out how many people in that department are treated in the same manner. Do you think that would be a good idea?
Mr. Dodge: Probably not. In any organization, there are both stronger and weaker areas. It is quite clear that, until recently, these problems have been festering and growing over a period of time. Our intent -- that is, Mr. Rock's intent, my intent, the intent of all senior management -- is to try to ensure that there is a working environment here that is productive for all scientists and all people in the department.
I cannot assure that this will happen overnight. As you know, some situations build up over a long period of time. Dr. Losos commissioned a study to try to look at some of these problems. There are problems there. Let us not try to sweep things under the carpet. It is now up to us to go about trying to fix them.
When extraordinarily serious accusations are made, I think it is inappropriate to follow the due process to protect those people who are making the accusations and those people against whom the accusations are being made. We must ensure Canadians that there is an objective handling of that.
Senator Whelan: You mentioned the system that one must follow for a hearing. My representative sat in on those meetings. She could neither record anything nor take any pictures. One person sat there as a judge, like God, and told her what she could and could not say. My researcher came back in a state of shock. She had some experience in court, but she said that she had never witnessed anything so one-sided in her life. Yet, you seem to put emphasis on this great system that will treat these people fairly.
Mr. Dodge: I cannot comment on that particular situation. Nevertheless, it is absolutely true that we are dealing with information that is proprietary. We must take steps that are rather different from what we take in university when we have these debates. Unfortunately, that is appropriate, and we must abide by it. I cannot comment on the particular situation that you mention.
You did also raise the science issue, though, senator. I can always be back here any time you want. We have asked the chairs of the two panels and an international expert to be here so that you can put your rBST questions to them. I am worried that you will run out of time before you can make the best use of the outside people. I am happy to come back any time to deal with any of these issues. It is harder to bring people from Australia.
The Chairman: On that point, we have ample time. We have permission from the Senate to sit past two o'clock, although we still have to hear from the Council of Canadians and the National Farmers Union. To be fair to them, we want to hear from them. We will certainly make time for your scientists to put forward their positions.
Mr. Dodge: They are not mine, senator; they are outsiders.
Senator Whelan: To be fair, Mr. Dodge, we certainly did not ask that someone be brought all the way from Australia at this time. The cost for that must be more than the cost to go from Ottawa to Windsor. I am worried. We cut out shoe shining on Parliament Hill, and I can imagine the cost of a trip from Australia to here would shine quite a few shoes.
Was it the intention to keep this study secret in Canada? Was the study withheld from the scientists at the Bureau of Veterinary Drugs who were reviewing rBST, and why?
A letter from Minister Rock dated October 21, 1998, states, in part:
Dr. Losos is the Assistant Deputy Minister of the Health Protection Branch ... responsible for and committed to ensuring that the process for reviewing rBST is thorough and meets all the drug approval process requirements --
However, Dr. Chopra testified last week that Dr. Losos never chose to meet to discuss any issues involving immunological derangements or possible birth defects with him or his review panel. Why not? How do you explain the discrepancy of facts between the letter and Dr. Chopra's testimony?
Mr. Dodge: Perhaps I could ask Dr. Losos to comment on that.
Mr. Losos: Senator, it should be clear that I have had a number of meetings with scientists and managers in the Health Protection Branch on the rBST issue. As a matter of fact, I had a very intensive three-hour session from seven or eight scientists, which included all aspects of the science, right after I came on board in the branch in June of 1997. It was to hear everything about the science of rBST.
As a matter of fact, I had questions about it. I specifically asked that the gap analysis be done.
Senator Whelan: You are not answering the question. Why did you not meet with Dr. Chopra? He asked to meet with you.
Mr. Losos: No, he did not, sir. I have never received a request from Dr. Chopra to meet me.
Senator Whelan: Nor from any member of that panel?
Mr. Losos: No, sir, never. I would be pleased to meet with any and all of them.
Senator Whelan: May we have copies of all the letters that people sent to you, then?
Mr. Losos: You can have everything I have.
Senator Whelan: I asked the witnesses who were here last week to submit copies of the letters that they had written and the messages they sent, et cetera.
I have before me a letter that I wrote to the minister. I am sure it must have gone through the Deputy Minister and, perhaps, down the line. I also sent one to the Prime Minister. I received an answer from the Prime Minister's Office that is being forwarded.
In the last month or two, we have received a great deal of information in the form of statements, et cetera. In your news release of October 21, you stated that non-scientific issues, such as social and economic matters, are not part of the scientific review. Surely there are economic issues involved here. We heard hours of testimony last week that this growth hormone has not only been improperly tested but that it is not needed, other than to provide potential profits to Monsanto.
Why do we spend all this time on something that is unnecessary? We have the best dairy cattle and the best dairy products in the world. We are even taking a chance with some of the dairy products that are being imported into this country from the United States. We do not know if they are safe, and neither do you. Because of this movement of products into our country, some unfortunate Canadians are eating products that are partly made, if not wholly made, from those imported dairy products. That is very dangerous.
Mr. Dodge: Senator, I will decline to comment on the economics of the situation. In terms of what comes into the country, it is my understanding that dairy products that are produced from milk containing rBST in the United States are not for sale in Canada. However, I will ask Mr. Losos who knows the answer directly.
Mr. Losos: There are processed products which come into Canada from the United States in which rBST may have been used. It is possible that some of those products contain rBST-stimulated milk.
Senator Whelan: That is what I said. We have been dilly-dallying around for 10 years; yet we have only a 90-day test program. There are results which Monsanto has not brought forward from their own information. However, I will wait until their people come before the committee to hear about more of that. I think there is enough evidence here that, if I were the minister, I would have ordered you to quit working on this right away until Monsanto brought in their results. That is because the cost recovery program that they have imposed on other departments is one of the things upon which you have to depend. You have to depend on those companies to pay for part of this research and testing. The millions of dollars that the federal government used to pay for such research and testing now has to come from these companies. You talk about economics, but who pays for that? Does it come from the sky? No. It comes from the people who use the products that I mentioned earlier.
My next question involves proving a negative. I have a friend who was in charge of all the research for Agriculture Canada for western Canada for several years. After that, he worked in Ottawa. He is retired now so nothing can happen to him. He says you can prove that something will happen, but in no way can you prove that it will not happen. You can prove what effects rBST will have, but you cannot prove what effects it will not have. My friend says it is a scientific fact and that any scientist knows you cannot prove a negative.
Will the use of rBST be like the use of Thalidomide with respect to which we first discovered the problem and then went back to find out what actually happened?
Is it not true that the dismantling of Health Canada's Health Protection Branch will cause food and drug industries to self-regulate the safety of their products? You are going to dismantle Health Canada's Health Protection Branch; is that not true?
Mr. Dodge: Absolutely not.
Senator Whelan: It is not true?
Mr. Dodge: Absolutely not.
Senator Whelan: I am glad to hear you say that, and I will watch it very closely.
I want to know if you have received any grants from any company, Monsanto or anyone else, to do work in Health Canada.
Mr. Dodge: How do you mean "grants from companies"?
Senator Whelan: It was suggested the other day that, if they pushed this faster, they might receive a $1-million grant.
Mr. Dodge: Obviously we have cost recovery. That is the extent to which we have dealings with companies. That is the extent to which we should have dealings.
Senator Whelan: We will go back to what Dr. Chopra said under oath. In his testimony, he quoted his assistant deputy minister as saying that if it is money and you cannot prove risk, then economics shall prevail and science will take a back seat.
Is this the attitude at Health Canada?
Mr. Losos: If I might answer that, senator: I have never said or conceived of such a statement.
Senator Whelan: Was Dr. Chopra lying then?
Mr. Losos: If it was an assistant deputy minister, it certainly was not me.
Senator Spivak: That is exactly the point on which I wish to proceed. Senator Whelan has raised a very important point because we will now have risk management in your modernization of the department instead of regulation.
Here is the point: As I understand it, 70 per cent of the funding of the Health Protection Branch comes from the companies. The funding goes into evaluation. The branch does not do any original research at all. As the very prestigious New England Journal of Medicine pointed out recently in an article, scientists who receive money from industry can have biases in favour of that industry. This is the essential point. If we are to have confidence in the Health Protection Branch, how can we have confidence when he who pays the piper calls the tune?
In that respect, I wish to ask Dr. Losos this question: When you came before us, Dr. Losos, you said that there had not been an official statement by Health Canada sanctioned by you or other managers saying this product is safe. You were referring to rBST. Senator Whelan raised the fact that this has gone on for 10 years. In 1990, there was a letter from Dr. Yong saying they were pleased to inform that they have completed their review of the new drug submission as it relates to human safety and have found the data acceptable and in compliance with the food and drug regulations.
How could such a letter have been sent without the branch following the normal procedures, that is, requiring Monsanto to do long-term studies, the studies that the Gaps Analysis report says had not been done, and how do you explain the discrepancy between your statement here in June and the official letter to Monsanto?
This is a particular instance of the general question. If you get 70 per cent of your funding from industry, surely you will be biased in favour of the industry's products.
Mr. Losos: I cannot answer for the letter in 1990, but certainly in recent times, and since I have been in charge of the branch, a statement by a scientist, perhaps on the radio or in a letter, does not necessarily mean that this is governmental policy or departmental policy. The buck stops with me, senator, and I either approve or do not approve this medication.
Senator Spivak: That raises a very important point because Dr. Yong was the Chief, Human Safety Division Bureau of Veterinary Drugs. He sent this letter. You have not repudiated this letter to Monsanto, or have you? Has Monsanto received a letter saying this is no longer accurate and does not hold, et cetera?
Mr. Losos: I do not believe so. I would need to check as to whether someone has written Monsanto back. As far as I am concerned, 1990 to 1998 is a quantum leap in science, and that statement no longer holds true.
Senator Spivak: Mr. Shugart, you talked very properly about how the public needs to be involved in the process and the public needs to know and we must provide information. There is a big difference between having a transparent process and having public relations.
Is part of your process to sell this process of cost recovery and risk management in the changing or the modernization of this department? I do not believe it was broken when Senator Whelan was there. Are you trying to fix something that is not broken and sell the public on it?
Mr. Shugart: Senator, I do not believe we would, as public servants, try to engage in public relations with a parliamentary committee either of the Senate or of the House. When we talk about reform of the health protection legislation, we are very clear that it is the responsibility ultimately of legislators to make those kinds of decisions on behalf of the public.
What I spoke to earlier was the fact that we are struggling with the important question of how to introduce into the regulatory and the decision-making process factors other than safety and efficacy. Clearly the science is responsible for dealing with those issues, but society is raising other issues -- ethical questions, social questions, cultural questions, and the like.
At the moment, there is no provision within our regulatory process for giving explicit consideration to those issues. The public is telling us, and we have discussed it already to some extent here this morning, that it is important that the process provide some legitimate means for dealing explicitly with those kinds of questions. That is what I was referring to earlier.
Let me address the issue of risk management. There is a fundamental misperception, and I wish to be absolutely clear on the record, that risk management is a code word for deregulation. That is simply not the case. Risk management is the decision-making process by which we identify the extent of the nature of a risk or a benefit in regard to health and make decisions about the most appropriate means of dealing with that issue.
For example, in respect to child communicable diseases, risk management is confronted with a problem. Risk management assesses the problem and goes through the process of deciding the appropriate method of dealing with that. In this case, it is widespread immunization of school kids. That is not regulation, but it is risk management.
I can tell you emphatically that the Department of Health will not be and is not contemplating and it would be unthinkable to imagine getting out of the business of regulating the health and safety of products. Risk management is not a code word for deregulation. It is not on the table. It will not happen.
Senator Spivak: What about this relationship of 70 per cent funding and the industry and self-regulation and who does the research? After all, the Health Protection Branch does not do its own research. It relies on research from the companies and from other areas. How are you modernizing that whole area?
Mr. Shugart: The policy of cost recovery, which has international counterparts and is applied in other parts of government, is, in effect, a tax on the companies which apply to have a product approved for sale. Our job is to undertake the review of those products, and that process is paid for to about the level of 70 per cent in the drug approval process in Health Canada through cost recovery. The administration of the fees is conducted by individuals who have no part in the evaluation process. The evaluators of the science have no role in the administration of the fees. There is a formula for that, and there is a process whereby the moneys go into the Consolidated Revenue Fund, and Health Canada is authorized by Parliament to expend in that area to the extent of those revenues that are received.
That is a matter of policy and, as a department, we live under that policy, but we are responsible for ensuring that there is an administrative process that separates entirely the evaluation of the science from the administration of the fees.
Senator Spivak: On that point, there was a memo from Dr. Landry in May, 1997, after cost recovery was put in place, which could give the names of the scientists to the companies. I believe it was felt that that would put additional pressure on the scientists. It is not quite as sealed hermetically as one would imagine.
The issue here is that we have seen this process and what happened to information that was given by Monsanto. I am not saying it was their fault, but it was a summary that was incorrectly summarized. It was completely false. The results were not right. Then they had to go back to the raw data.
This is an illustration of exactly what can go wrong in that sort of process. You will need to do a significant amount of persuading, and you will need to address the instruments you will use to ensure that such a thing does not become routine so that scientists are not pressured and no one is influenced by the fact that there is that kind of funding.
You are right that the issue of cost recovery will need to be addressed by politicians. However, I hope that you would give us a significant amount of information as to how this will work as compared to what has happened in the past.
Mr. Losos: Senator Spivak, the budget of the Health Protection Branch is about $250 million. The therapeutics program recovers about 70 per cent of its budget from cost recovery. That is a different unit from the Bureau of Veterinary Drugs and the foods program.
It is an interesting side note that Monsanto's submission is grandfathered and that Monsanto does not pay for the submission.
Senator Spivak: Do you not also have a joint management committee in the department on which industry representatives and department managers sit, but no scientists?
Mr. Losos: That is in the therapeutic programs part of the department. There are numerous other scientific fora within that unit and within the rest of the Health Protection Branch.
Senator Spivak: Still, it is an invasion of the industry right within the processes of the department.
Mr. Losos: A reality, senator, is that we have a business relationship with industry. This is not a friendly relationship; it is a business relationship. Our business is health and safety; their business is products. Therefore, we have a business relationship with them.
Senator Spivak: I will not comment on that public policy.
Senator Sparrow: Has there been any or much interdepartmental consultation between Health Canada and Agriculture Canada in respect to rBST? Would there have been reports coming from Agriculture Canada to Health Canada relating to the economic aspects of the approval of the drug? If so, would those reports be available to this committee?
Mr. Losos: Mr. Chairman, I ask you your indulgence for Mr. Paterson to join us.
There have been interdepartmental mechanisms over the years on bovine somatotropin. Mr. Paterson can perhaps answer your questions in that regard, and the documents would be available to you.
Dr. George Paterson, Director General, Foods Directorate, Health Canada: Would you mind repeating your question? It is difficult to hear from the back of the room.
Senator Sparrow: What types of interdepartmental consultation have taken place between Health Canada and Agriculture Canada pertaining to rBST, particularly in reference to the economic aspects of the approval of the drug itself?
Mr. Paterson: As I indicated in June when I attended the Senate committee and made a presentation, there is an interdepartmental process in place. It involves more than just Agriculture and Agri-Food Canada. It involves Industry Canada and the Department of Foreign Affairs and International Trade, to name two. That process is to coordinate and share information.
The record of the June meeting will show that the decision on whether rBST is approved or not is Health Canada's responsibility. That has been adequately covered in earlier testimony and today.
Our discussions have not looked into detailed economic analysis. To answer your question, there is no detailed economic impact assessment study that has been done of which I am aware through that interdepartmental process.
What has been discussed through that interdepartmental process are hypothetical situations. I explained this in my presentation in June. If the drug were to be approved, because of the supply management system in Canada, the role of the federal government, the Canadian Dairy Commission, as well as the provinces in terms of milk supply, there would be implications that go beyond just the approval of the drug and the conditions of approval.
Mr. Losos indicated that in approving the drug, we could put various conditions on it. As was indicated last week in the testimony, in the U.S. situation, the label has many such conditions. Beyond that, looking at the consumer who would be consuming milk and milk products, there are implications in the context of consumer awareness and negative and positive labeling which I outlined in June.
Also, international trade issues have been discussed interdepartmentally. There has been no detailed economic impact assessment discussed at that forum; therefore, I cannot say that there is a report that I can provide to you, senator.
Senator Sparrow: Mr. Chairman, the witness continues to refer to a detailed economic report. You are suggesting there are some economic reports, though, perhaps not detailed. The economics can be important in the total aspect, even when we talk about supply management. Supply management in this context is a bit of a red herring.
If you produce 10 per cent more milk, a farmer, for the same income, requires 10 per cent fewer cows. I am wondering if those types of economic aspects were brought into play between the Department of Agriculture and Health Canada. There must have been some reports.
Mr. Paterson: Let me clarify, senator. There are no reports or studies of which I am aware. If the Ministry of Agriculture and Agri-Food Canada through the policy branch have done a study, I would suggest that the question would need to be raised with them. I am not aware of any.
Senator Fairbairn: Mr. Losos, I do not know whether it was you who said this or one of your colleagues. However, at the basis of much that we have been working on is the Gaps Analysis report. Did you say that you had ordered that report?
Mr. Losos: Yes, senator. When I took over the branch, this was one of my larger files. I wanted to get the detailed scientific analysis and one intensive one. I came out of there with questions.
I then required Dr. Paterson to put together a scientific team. It is not at all unusual to go through the records and identify the gaps in the science where that may be important. For example, I had some questions about the immunogenicity of the various products and side products. I wanted more information about that.
At the same time, given the complexity and the international debate going on, I ordered Dr. Paterson to strike the two expert panels, arm's length, blue-chip, international panels that would give us the absolute best quality advice that we could find.
Senator Fairbairn: Was part of your concern based on some of the concerns that have been shared with this committee by some of the scientists from the department?
Mr. Losos: Absolutely, senator.
Senator Fairbairn: Those concerns formed part of the reason for the move to do a gaps analysis report?
Mr. Losos: Absolutely. Wherever there is a gap, we want it filled before we approve anything.
Senator Whelan: Do you agree with anything that the scientists presented to us here last week?
Mr. Dodge: Yes. What they said, quite rightly, is that their job is to ensure the health and safety of Canadians. Quite rightly, as they said, they raised some real scientific issues that had to be examined. They had doubts. There were a number of problems. Senator, there is no question about those things.
They made a number of allegations about the process which, as I have said, are either under investigation or which I will examine because they are serious process allegations.
Senator Whelan: I am sure you are aware, from the line of questioning, that many of us have some deep concerns about the process and about what they could and could not say inside or outside of this room.
Mr. Dodge: There is no question, senator, about what they can say in this room. They are under obligation to answer any questions that you put to them. There should be no misunderstanding.
Senator Whelan: What about outside this room?
Mr. Dodge: As in every department, in speaking to the media, we use departmental spokesmen. That is the normal process. On scientific issues, absolutely they speak on those issues, subject to that one problem issue I mentioned, and to which I return, which is that there is a lot of proprietary information here.
Senator Whelan: We will go into that further. Regarding the two committees you appointed, I have strong reservations about the one from the Canadian Veterinary Medical Association. That association has endorsed rBST. I do not see how you could find six or eight independent veterinarians who would have an independent view. We have done some checking on whether any of them objected to the organization endorsing rBST, and we have not found anything.
Mr. Losos: Senator, you can put that question to them, but certainly these two arm's length organizations were chosen for their expertise and integrity. We went through all the necessary steps, including checking for conflicts of interest. I would invite you to ask that question of the chairs of the two panels.
Senator Whelan: You talk about this drug and about how much money and time you have spent going through all the statistics and all the data that you could find. I can find no record of any farm dairy group or dairy council asking that this drug be brought forward.
The National Dairy Council of Canada, which is responsible for all the processing of dairy products, has said they are dead against this product. I have talked to the chief executive officer and president of that organization. He told me they are concerned that, if something is found down the line, the council will be hold responsible because they process and market all these dairy products.
Are all these people wrong when they come before us with their very strong stands? I was amazed at how strong their stand was. Here are the people responsible for this product. As I said before, it would not have taken me very long to issue an order that we discontinue this until more data is brought forward by Monsanto, the company asking for rBST. Monsanto should have to prove the product is safe.
The people in the dairy council are successful business people with over 400 processing facilities across this land. The dairy farmers did not ask for this either.
Do we just grab onto anything that any company brings forward, requesting to sell it to farmers? Are we going to inject this hormone into cows to produce more milk just so that farmers can make more money? We talk about economics, but social and economic concerns are combined. I do not care what you said in the press release; you cannot separate them from one another.
I do not see that the Canadian Veterinary Medical Association would pass on endorsing this product when many of them work with the drug companies. They are agents for different drugs companies. They make money from selling the product. I know some veterinarians are against it, too. I have asked them if they have gone to their organization and told them that they do not like the organization endorsing certain products.
Mr. Dodge: Senator, we are obliged by law to review any product that is brought forward in the prescribed manner, and I think you would want it that way.
Senator Whelan: I want to ensure that my cows are protected, and that I am protected, too. Nothing you have said today has reassured me of that. You have said that these other scientists, who are highly qualified people, are basically not telling the truth. Where do we go from here?
Mr. Dodge: All I can do is continue to be open and to give you assurances about the process. The long and short of it is, as Dr. Losos said, that to date, evidence has not been brought forward to satisfy Health Canada that this drug is safe for human or animal consumption. It is not approved. It will not be approved until such time as that evidence is there.
Senator Whelan: I want to go back to the Health Protection Branch again. There was the following headline in The Hill Times: "Canadian Health Coalition lobbies against Health Protection Branch transition hearings, calling them `smokescreen.'" The article refers to Dr. Michele Brill-Edwards, a former senior regulator at Health Protection Branch, saying she is now one of its sharpest critics, and it goes on. I do not know if you have had a chance to read this, but if these people are running around, as you say, giving us this scary presentation, you should counteract it.
Mr. Dodge: Senator, we are not in a position to stop people from making allegations. Our job is to deliver the proper service to Canadians. That is what we are trying to do. When serious allegations are made, obviously we must look into them and, if they are founded, we must correct the problems that have been raised. That is our job.
Thank goodness we live in a country where there is free speech and where people can leave a department and say these things.
What is critical is that no one should be too quick to assume that everything said is absolutely the truth until it is investigated. That is what we are in the process of doing.
Senator Whelan: This is a simple thing. You said to me that there is no way we will get rid of that branch. However, these people are saying the hearings are a smokescreen. I think you are obligated, as Senator Ghitter said, to publicly put us at ease that you will not downgrade this branch, but that you will upgrade it and give it more stature.
Mr. Dodge: As we all know, the proof of any pudding is in the eating. If you do not want to be convinced, there is no way I can convince you today.
I invite you to watch the actions. In fact, you will be doing more than watching them. We will be back to Parliament with some changes over the next several years and come to a conclusion.
All I can say categorically is that we are in the process of building a Health Protection Branch that will protect the health and safety of Canadians in the 21st century.
Senator Whelan: I am not that hard to convince. I have been in public life for almost 40 years, many of those years as an elected representative. I have been an appointed senator for three years. My record shows that I want things to be done fairly. I want people to be dealt with fairly. I have strong concerns about what is happening not only in your department but in other departments in the government. Ordinary people cannot talk to their minister anymore. They have to go through about seven people before they get to the deputy. I was never like that as minister. I had 12,000 civil servants in my department. If they wanted to see me at an office in western Canada, if they thought the top bureaucrats were treating them poorly, I would talk to them. That eliminated many requests because they knew they had an avenue they could follow.
Senator Spivak: I want to say to Dr. Paterson that, in testimony here, one of the participants from the dairy council told us that economic studies were done on whether rBST would indeed be profitable for farmers, and that some of them were quite negative. In other words, there would not be that much profit, nor would there be a 10 per cent or 15 per cent increase in production. That was an average figure.
The question I want to ask is about labelling. I understand that if Health Canada says a food or drug is safe, then it is not necessary to label it, that any labelling is voluntary, according to the legislation. It seems that this might be our next target. That means that my rights or anyone else's rights as a consumer to know everything that goes into that product would be abrogated and therefore I would not know whether the milk I was buying was produced with rBST cows or not. What is your view about the whole labelling process? Am I correct in my assumptions?
Mr. Paterson: That is a good question. Again, I think I go back to June when that also came up. Hypothetically, if rBST were to be approved for use in Canada, that would mean that Health Canada, as the federal government department responsible, had determined it to be safe for use under whatever conditions. As such, labelling could not be demanded. Labelling is not our prerogative. It is the responsibility of the Canadian Food Inspection Agency as part of Agriculture and Agri-Food Canada.
Labelling would have to be balanced. In other words, if you sold milk or cheese from rBST treated cows, there would have to be a balancing statement, such as "Health Canada has determined that the use of rBST presents no safety risk." This is how the issue was treated in the U.S. used, not that we are comparable to the U.S. Hypothetically, the legal opinion is that that would be necessary.
Senator Spivak: I raise that question because the famous 90-day rat study did not look at what impact this might have on children. Children drink the most milk. If Health Canada, based on that rat study, says it is safe, mothers might want to be extra cautious. Surely they have the right to know. If we do not label it, they will not be able to determine whether they should give their children milk which has rBST in it or does not have rBST. I think that is another very important issue you might want to address in your review of the department.
Mr. Losos: That is an excellent question. It might be a terrific first question for the scientists.
The Chairman: Thank you. I will now ask Dr. Losos to introduce the witnesses who are at the table with him.
Mr. Losos: First, I wish to make a short opening statement. This committee's work is an important contribution to this file. I welcome the chance to come to the committee this week to answer the questions and concerns raised last week, and for months and months, around this file.
As its senior scientist and the Assistant Deputy Minister, I am responsible for the programs of the Health Protection Branch. I have been in this position since June of 1997.
Every day, the Health Protection Branch handles hundreds of safety transactions. I and my senior scientists and science managers are personally involved in dozens of these transactions every week.
The Health Protection Branch is a science-based organization with a focus on food safety, on safe and effective drugs and medical devices, such as, for example, heart implants, on biologicals, blood, blood products, vaccines, and environmental health risks. It also leads the provinces in national disease surveillance and control.
It is important to note that the one reason for the existence of this branch is the health and safety of Canadians. I should like to put to rest this idea of who the client is. There is only one client for the Health Protection Branch and that is the Canadian public. I should like to put that on the record. That is the way it is.
As the Assistant Deputy Minister and senior scientist, I require that our programs play a unique and leading-edge role in the science of health protection. This is not a university. I require that they aspire to achieve the level of scientific excellence required and demanded of such an organization, that they have in place the capacity and the networks to assess absolutely all of the knowledge available on whatever subject they are managing, that they have the management processes and mechanisms in place to ensure that their work is effective, efficient and standard-driven, and that there are mechanisms in place to address all differences of scientific opinion to allow for the proper scientific challenge. We welcome proper scientific challenge and we want to ensure that expert review, both internally and externally, is fully utilized in our health protection role.
I have led and managed science organizations for over 25 years and I have yet to see a black-and-white answer. I require my scientists and my scientific managers -- and, frankly, all the staff at the Health Protection Branch -- to work collaboratively and expertly, and to focus on that one role of health and safety. I also require the branch to build on this success. It has been a successful unit and continues to be so, but it must build on that success as the "hurricane watch" of health and safety, and it must adjust to the global upheavals of instant communication, the explosion of technologies, and international travel and commerce.
In the field of biotechnology, there will be an increase of 200 to 500 per cent in products over the next decade. How does all this apply to rBST? The fact that the Senate has taken up this subject reflects the fact that it is a subject of intense international scientific discussion. International agencies are reviewing it. Some countries have approved it, others have not. I have not approved it, and I will not approve it unless my scientists, myself and our advisors are satisfied that it is safe.
I require that the scientists touch all their bases in their analysis. I found some of the testimony of last week disturbing because it inappropriately attacks the integrity of the branch and its scientists and creates anxiety in the public, which is totally inappropriate.
We have over 2,100 scientists in the Health Protection Branch with very high integrity, high ethics and an incredible work ethic. When disparaging comments are made, they are affected.
There are mechanisms in place for concerns and complaints, as Mr. Dodge explained, for scientists to be heard. These complaints will be properly addressed.
I and the senior scientists of the branch were not satisfied that all the questions were answered with respect to rBST, so I ordered that gap analysis. That was done and, in fact, questions remain. This is standard practice in any scientific organization.
I then ordered two expert panels. One was on human health and safety under the aegis of the Royal College of Physicians and Surgeons. For those not familiar with that organization, they certify absolutely every medical expert in this country, from heart surgeons to medical specialists, whatever. This is a pristine body which is at arm's length from us. Its integrity is beyond compare.
The second panel was the animal health panel, under the Canadian Veterinary Medical Association.
I have invited the chair of the joint expert committee on food additives, Dr. McLean, who is former Dean of Faculty of Applied Science and Pro Vice Chancellor, Division of Science, Swinburne University of Technology in Hawthorne, Victoria, Australia, to provide senators with insight into to the workings of the international group, or into other scientific issues, if you are interested.
I have asked the chairs of the two panels to accompany me today. The first is Dr. Stuart McLeod, Director, Father Sean O'Sullivan Research Centre, McMaster University, St. Joseph's Hospital, Hamilton. The other is Dr. Ian Dohoo, Associate Dean of Graduate Studies and Research, Atlantic Veterinary College, University of Prince Edward Island. I am certain, senators, you will agree that this is an absolutely blue-chip panel.
I will ask each of them in a minute to explain their role to the committee and to answer any and all of your questions.
Mr. Chairman, I said at the beginning that I needed the branch to increase its expertise in tools and resources in order to be able to adjust quickly to the changing global environment. rBST is not the only issue facing this branch. Indeed, it will be evaluating many of the biotechnology products that will arise over the next decade. Because of this, a transition into a stronger, better-positioned branch is vital.
The Minister of Health has announced an initiative over three years called "Transition," about which you have already heard during this morning's testimony, and I will ask Mr. Ian Shugart, who is the senior manager in charge of coordinating this program, to give you a quick introduction and answer any questions you might have on that program.
I should also like to introduce Dr. Yves Morin, the past Dean of Medicine, Laval University, who is vice chair of the minister's Science Advisory Board, about which you may have heard. The chair is Dr. Roberta Bondar, who was not able to be here today. However, Dr. Morin has consented to address the committee and answer all of your questions. The board's job is oversight and guidance, at arm's length, of our rebuilding process.
With that, Mr. Chairman, I will ask the panel members to give you a few opening comments.
Dr. Stuart McLeod, Chair, rBST Human Safety Panel, Director, Father Sean O'Sullivan Research Centre, McMaster University, St. Joseph's Hospital, Hamilton: Mr. Chairman, it is a pleasure to be here and to see the important workings of your committee.
The issue you are grappling with is a challenging one. It is a little unusual, as I think your questions have reflected this morning, in that we are not dealing in this instance with a product that is designed for direct human use. Some of the difficulties you are encountering relate to the fact that you are trying to interpret indirect effects, effects that may occur downstream from the treatment of dairy herds. That opens up a whole new framework for the drug evaluation necessary as part of health protection.
I do not think it will help you if I make a lengthy statement about the science. However, I might say a bit about the process.
I was contacted early this year, I believe in February, by Dr. Hugh Scott who, at that time, was the Executive Director of the Royal College of Physicians and Surgeons. He subsequently moved to Montreal to head the McGill teaching hospital initiative. He discussed with me the need in Health Canada for a dispassionate external view to address the kinds of issues that were coming to a head with regard to the gap analysis within the internal review team. It was recognized that there might be a need for some outside intervention to say which of these gaps were, indeed, critical, and which ones deserved further study.
That is the basis on which I agreed to chair a committee to look at the scientific evidence that was available, to decide whether that was adequate or inadequate. Certainly, our mandate did not include getting into some of the other social and value issues that have been raised around the table this morning. Those are extremely interesting -- in fact, they are critical to the whole health protection question -- but they are not, as I understand it, within the remit of the Health Protection Branch in deciding on the acceptability of products for sale.
My committee is multi-disciplinary. We felt from the outset that we needed to have paediatricians on the committee, because children are the major consumers of milk in this country. We needed to have oncologists, because there are concerns about possible cancer risk, at least with IGF-1, which is a downstream result of rBST or growth hormone administration. We also needed to have pharmacologists and toxicologists. That is the kind of committee we put together.
We have had a couple of meetings by teleconference, and we have had two face-to-face meetings. We have contended with an immense volume of information. We received eight volumes from Health Canada, and I know you have pointed out that that is not the whole file. I gather there are at least 40 volumes of data. However, we have searched the international scientific literature for additional information. Thus far, we have considered anything that we think is relevant to the questions that we have been asked.
We met as recently as a week ago. I am confident that the committee will produce a report which will be helpful to you on the scientific issues, but it will certainly not address all of the related issues of societal values that are important to this question.
The Chairman: Thank you. I wish to welcome Mr. McLean from Australia. Welcome to Canada. Proceed, please.
Dr. Stuart McLean, Dean of Faculty of Applied Science and Pro Vice Chancellor, Division of Science, Swinburne University of Technology, Hawthorne, Victoria, Australia: Mr. Chairman, it is a pleasure to be here. I am very interested in your proceedings and the difficulties that you are facing.
My involvement in this area comes about because, since 1972, I have been involved in the regulatory process in Australia and, since 1987, the regulatory process in the international sphere.
I come as a private citizen. I want to make it clear that I do not speak on behalf of the World Health Organization or the Food and Agriculture Organization when I tell you what goes on in the Joint Expert Committee on Food Additives. I am not able to speak on behalf of either of those organizations. I think it is important that I say that at the beginning.
The Joint Expert Committee on Food Additives was formed in 1987 to examine the safety of residues of veterinary drugs in food. It is composed of members drawn from the World Health Organization, which looks at the toxicity, and the FAO, which looks at the residue, chemistry and analysis. It has groups of independent experts, and their independence is jealously guarded by the committee. In fact, one must make a declaration that you come to the meeting independent of your organization or the country from which you come. The committee also has the capacity to co-opt specialists as necessary.
The committee reaches its decisions by consensus, but minority or dissenting reports are permitted. Although that was not the case with bovine somatotropin, dissenting reports have been submitted in the activities of the committee in the past.
BST has been studied by JECFA on two occasions, once in 1992 and again in February of this year.
In the review that took place in February of this year, there were two important people co-opted by the committee. One was a Dr. Michael Hanson, who represented Consumers International.In order to ensure that that organization was not penalized by not being present, the World Health Organization paid his expenses. The other person was Dr. Chensick from Chicago, whose specialty is endocrinology, particularly human growth hormone and insulin-like growth factor.
JECFA gives advice to, but is independent of, Codex Alimentarius. There are a number of international organizations that actually use the results of JECFA independent of the Codex process. JECFA publishes all its work in the open literature, and those publications that relate to BST are now in the open literature. The most recent volume appeared last week.
In relation to rBST, the data that were reviewed came from sponsors, from government agencies, from literature reviews, and expert reports. For BST, JECFA looked at data from four separate sponsors in 1992, because at that time four companies were developing bovine growth hormone for administration to cows to enhance milk production. Although the Canadian group was only studying the product from Monsanto, we have seen all of the data from four sponsors.
We have also examined the complete spectrum of data, because it is our policy that if summaries or incomplete data are submitted then we would note that in the monograph, and if the missing or incomplete data is pivotal, we may not process the compound further until that gap is filled.
In 1992, we determined that it was not necessary to promulgate an acceptable daily intake for BST because of the lack of compound-related effects and the fact, which is important, that it is not possible to regulate the use of BST by the analysis of milk. It is not possible to tell the difference between treated and untreated milk. That is a challenge to those who wish to proceed with, for example, labelling. If you have a law that cannot be enforced, then that produces a number of difficulties, as you would appreciate.
In relation to the studies that were considered, particularly the short-term studies, I am aware that there are certain issues being raised in relation to a particular 90-day study, but it is interesting that immune responses to dietary intake are common in food. There was an examination of the rats that responded and there was no detection of the presence of BST in the plasma of those animals. All of the trials were carried out by stomach-tubing rats. I can assure you that if you stomach-tube a rat every day for 90 days, it is not long before he or she becomes uncooperative. You always get a small amount of the material inhaled. It is like giving a small child medicine. If you do it regularly enough, you will find that they cough after receiving small quantities because they have inhaled a little bit. That produces the sort of the immune responses that are seen. Some of the other responses that are reported in our literature are not does-related and commonly seen in the strains of rats used.
We also studied IGF-1 in 1992, and it was deemed to be not significantly active orally. IGF is widely distributed in all tissues and secretions, such as saliva and secretions of the gastrointestinal tract, and while it is increased after the administration of BST, the increase is very variable and, under some conditions, it could not be shown to be significantly increased.
When our report went to Codex Alimentarius, there was a delay of approximately 18 months in the committee process and they requested that we re-evaluate BST in the light of new material that had come forward. In this review, we openly requested submissions from all sources. We received an enormous amount of material, which ranged from individual lay people expressing concerns, to organizations that had a particular issue that they wished to put before us, to government bodies and to sponsors. We were overwhelmed by the amount of material we received.
The first issue that was of concern was mastitis. JECFA only looks at safety in food, and so the only concern that fell within its purview was that of antibiotic residues, and, to all intents and purposes, there was no increase in antibiotic residues. The protocol was slightly confounded by the fact that, in the middle of all this, the United States altered the sensitivity of the test. However, it is important to remember is that all milk is sampled for antibiotic residues. If milk is found to contain antibiotic residues above a critical level for the starter cultures of yoghurt, cheese and other milk products, then it is rejected and the farmer is penalized. Those methods are more sensitive, resulting in lower levels than would normally be applied for human toxicological end points.
The levels of BST in milk after treatment are around the level of detection; in other words, extremely low. IGF levels do increase but the increase is small and variable. Taking the range up to the worst case of the increase, then the amount of extra IGF that might be found in milk varies between zero and 2,000 nanograms per litre.
Concentrate on the figure 2,000, because in a normal human being that 2,000 is put into a human production of 10 million nanograms per day. You are adding 2,000 to a normal production of 10 million. We are living in a virtual sea of IGF as we sit here at the moment, and the additional amount that you would take in from a litre of milk would vary between zero and 2,000.
We also studied the effects on retroviruses because there had been suggestions that treated milk might influence the course of AIDS. We looked at the effects on certain proteins related to bovine spongiform encephalopathy, or mad cow disease. We looked at insulin-dependent diabetes and tumour incidence.What we found in the re-evaluation was that there was no effect in any of these areas.
I am not here to champion the cause of BST. I am interested in human safety. In my opinion, there are no outstanding safety issues. I have studied this compound in committees over a period of 10 years. We have had exhaustive discussions. If I had any doubts that it was unsafe, I would say so.
When we come to the issue of safety, nothing is absolutely guaranteed under any circumstances. If we wanted to aim for absolute safety, then we would spend all of our budget ensuring that, and there would be nothing left for the important issues. Absolute safety is not achievable. The safety levels that are associated with treatment with BST do not warrant our going any further in trying to ensure safety there, but rather putting resources into other areas.
The Chairman: Is this drug licensed in Australia?
Mr. McLean: The situation in Australia is complex. The toxicology has been evaluated and we have an entry in our table of maximum residue limits. However, the Australian legislation requires us to take trade into account. As a number of countries around the world have not reached a final conclusion with BST, then our processing of that is on hold.
The situation is further complicated by the fact that the trials to determine the sorts of responses that you would get from cattle under Australian conditions show that the increase in milk production is, on average, relatively small. That is because our dairy husbandry practices are different from those in your country. All our cattle stay outside and graze pasture. The energy consumed in that pasture grazing does not allow for the responses that you would get in cattle that spend most of their time in the barn. Therefore, the sponsor that was putting forward the case for registration also has it on hold because there may not be an economic benefit. That is the situation in Australia.
Dr. Ian Dohoo, (Chair, rBST Animal Safety Panel), Associate Dean of Graduate Studies and Research, Atlantic Veterinary College, University of Prince Edward Island: Honourable senators, I should like to explain the process of the establishment of the animal efficacy and safety panel under the aegis of the Canadian Veterinary Medical Association.
The CVMA accepted a request from Health Canada to establish an expert panel and started looking for someone to chair it. I was approached in that capacity and agreed to take that job on in February of this year.
During March of this year, I undertook to try to identify appropriate people who would provide the expertise necessary to fulfil the mandate of the committee.
One of the primary areas where I felt we needed expertise was in the field of dairy health management. To that end, it was fortunate that two very prominent dairy clinicians from academia, Dr. Ken Leslie of the Ontario Veterinary College and Dr. Luc Descoteaux of the École de médecine vétérinaire in Saint-Hyacinthe, agreed to serve, as did Dr. Wayne Shewfelt, who is a private practitioner specializing in dairy health management.
I also felt we needed expertise in dairy nutrition, so I contacted Dr. Alan Fredeen, of the Nova Scotia Agricultural College, a prominent dairy nutritionist, and he agreed to serve.
I also wanted expertise in clinical pharmacology, and Dr. Patricia Dowling of the Western College of Veterinary Medicine agreed to bring that expertise to the committee.
Finally, I thought it was important that we had expertise both in livestock management in general and in animal welfare, and Dr. Allan Preston, a former practitioner and a former chair of the animal welfare committee of the Canadian Veterinary Medical Association, agreed to bring that expertise to the panel.
I have heard the panel described as blue chip. That is not a term I had ever heard applied before, but I was certainly very pleased with the expertise that came forward to serve.
We had our first face-to-face meeting of the panel at the beginning of May. Much like Dr. McLeod's panel, we have functioned independently since then, with several face-to-face meetings and several conference-call sessions. We have looked at material provided by Monsanto in their submission to Health Canada, as well as information from Health Canada and the published literature that may not have been included in that submission.
We are approaching the end of our mandate, but our report is not finished yet. Therefore, honourable senators will understand that I am not really at liberty to discuss findings or conclusions from the panel because that is still under the editorial process. We do not have our final conclusions in place.
Mr. Shugart: Honourable senators, we have already had some brief discussion this morning of the work of our transition project. It may be useful to the committee if I briefly outline the work that we are doing to strengthen and improve our capacity to support the work of health protection. We are one year into this project and anticipate a further two years of fairly intensive activity.
As I indicated previously in discussion with Senator Spivak, we are working to improve our risk-management decision-making framework. This is not a code for deregulation; it is rather a tool for decision-making that helps scientists and managers make the best decisions on health risks and benefits.
We include in our work in this area an examination of how to build into the process ethical, social, economic and cultural factors that may be relevant, and an examination of how to provide for greater public participation in the process.
We are also working to strengthen the science platform on which our health protection program depends. This will always involve having a strong in-house capability in order to take part effectively in networks and scientific exchange, domestically and internationally. This means having strong conflict-of-interest rules and human resources policies in place that will allow for ongoing renewal of our scientific staff.
We are also working to develop the most effective health surveillance tools possible. Our goal is to have an effective public health partnership where information is gathered, analyzed and used, with good, common standards, strong privacy protection and a good system for setting priorities and evaluating the results. We share that challenge with every jurisdiction in the world.
We are reviewing our programs in order to ensure that our activities will have the most significant effect on the most significant health challenges. For example, we and many others have conducted much activity in the area of injury prevention, but we have not had up to now a consolidated, co-ordinated program in that area.
Finally, we are engaged in a review of the legislation that underpins health protection. We presently administer about 12 separate pieces of legislation. While these have served us well, we are seeking to reform the legislation to take better account of modern realities such as biotechnology and to ensure that the necessary tools to maintain health and safety are available.
We are assisted in this process, as Dr. Losos has indicated, by the Science Advisory Board, which is a permanent source of independent and expert advice to the minister. The board has already demonstrated the value of outside scrutiny and vigorous critique of everything from our science to the decision-making process.
Senator Whelan: My first question is to Dr. Dohoo. Are you the head of the School of Veterinary Medicine at Charlottetown?
Mr. Dohoo: I am the associate dean there.
Senator Whelan: Is it true that the Canadian Veterinary Medical Association has officially endorsed rBST?
Mr. Dohoo: I am glad you asked that question because I would like to set the record straight.
When I was approached about serving on this committee, the first thing I did was contact Claude-Paul Boivin, who is the executive director of the Canadian Veterinary Medical Association. He asked me if I was aware of a previous statement by the CVMA with regard to BST. I was not aware of it. He wanted to bring it to my attention. He was very concerned about that because he wanted to make it absolutely clear to me that that statement did not represent an official position of the CVMA.
To give you a little bit of history, I believe it was in 1994, shortly after the product had been licensed in the U.S., that the CVMA made the statement that Canadian veterinarians play a prominent role in the health management of dairy cattle. It is true that across this country they do play a very important role in that area.
That was inadvertently included as a position statement. I do not know how that happened. However, Mr. Boivin assured me was that that was not the position statement of the CVMA. I am sure that if you contact them now, they will reiterate that CVMA does not have an official position on rBST.
Senator Whelan: I do not remember ever seeing a public statement by them saying that that was not an official statement.
Mr. Dohoo: I cannot respond to that. You would have to contact the CVMA. I am not sure whether our current president has issued a statement about that.
When I first talked to Mr. Boivin about serving as chairman of this panel, it was made clear to me that this panel would be completely independent of the CVMA. Given that, first, it is not a CVMA position and, second, our panel operates completely independently of the CVMA, I can categorically assure you that our panel does not feel, in any way, shape or form, bound by any previous statements which may have been published.
Senator Whelan: Are you doing any experimental or research work on rBST at the school of veterinary medicine at Charlottetown?
Mr. Dohoo: No, I am not.
Senator Whelan: Dr. McLean, you were asked to come to Canada, were you not?
Mr. McLean: Yes.
Senator Whelan: How long ago was that request made?
Mr. McLean: Last Friday evening.
Senator Whelan: Dr. Losos, why did you fly this learned doctor all the way from Australia when you have a member of the JECFA, Dr. Len Richard, right here in Canada?
Mr. Losos: Senator, we wanted you to hear from the chair of the committee so that you would get a better view of much of the international workings that the chair would have at his fingertips.
We wanted to demonstrate, as I said earlier in answer to a question, the various mechanisms we have in place for ensuring the safety of drugs and the full science focusing on that. This panel is a perfect example of that. Dr. McLean, as chair of JECFA, is one of those mechanisms.
Senator Whelan: Dr. McLean, you said that this has to do, in part, with trade. I gather that is because markets in Europe, where you may be selling butter or cheese, have strong rules against rBST. Is that right? The ruling of New Zealand on rBST is even stricter, I understand it, than that of Australia.
Mr. McLean: That is essentially correct. We do not want to jeopardize our trade position or end up with an artificially imposed trade barrier because we use rBST. However, as I said, there is no way of telling whether the produce was treated. Therefore, it is somewhat a theoretical point.
Senator Whelan: Some of us do not think it is theoretical. You have not proved it is just theoretical either.
Mr. McLean: I am saying that the fact that you cannot detect the presence of treated produce makes the enforcement of the law a very difficult thing.
Senator Whelan: Two or three years ago, McGill University was doing research to learn whether there was any carryover in the milk from a cow injected with rBST. I was told that they were very close to finding a system that would detect it, when the research was cut off. Again, the research grant was coming from one of the big companies.
You are not aware of that?I thought you would be aware of all these things when Codex, this great secret body, is going to make a decision on whether food is safe for us.
I have strong reservations about Codex, and I do not mind telling you that. At the recent meeting here in Ottawa, the Canadian representative abstained but the Australian and New Zealand representatives voted with Americans. What business do they have voting with the Americans when they do not allow it to be used in their own country?
Mr. McLean: JECFA is completely independent of Codex. JECFA has nothing to do with the Codex process.
Senator Whelan: I thought you were part of it.
Mr. McLean: No, no. We give independent advice.
Senator Whelan: They use your advice, though.
Mr. McLean: Sometimes; when it suits them.
I should like to make the point that my colleague is a temporary adviser to JECFA. He is not a member of the committee. There are two groups of people who go to JECFA: members and temporary advisers. There is a distinction.
Senator Whelan: He was rather controversial when he gave evidence before the House of Commons committee in 1994.
The Chairman: Dr. McLean, as we move toward a global economy, how important is a level playing field in these areas?
Mr. McLean: To turn it around the other way, it is important that one is not disadvantaged by the presence of a level playing field. I am sure that the problems faced by Australia and New Zealand are very similar to those faced by Canada. In fact, last year, I appeared as a scientific witness at the trade dispute that Canada and the United States were having with the EU over hormone treated beef, so I am pretty much aware of the ramifications of a level playing field or lack of it.
Senator Spivak: Dr. McLean, apparently there is indeed a method of detecting hormone-free milk from non-hormone-treated milk. A company called Genetix has a test that they say will enable producers and processors of milk products to distinguish between naturally produced milk and milk from hormone-treated dairy cattle. They say that retailers of milk products can use this test to verify product sold as natural or hormone-free.
You might want to follow that up in your study.
Mr. McLean: Mr. Chairman, I am aware of some of those tests. However, some of the BST that is available is identical to the naturally occurring BST. Therefore, when it comes to applying such tests to articles of commerce -- in other words, bulk milk -- while it might be theoretically possible to tell the difference, you could not launch a prosecution because too many chemists would appear for the defence and you would not win. I wish we could.
Senator Spivak: As I mentioned earlier, aside from the legal process, the rights of consumers would then be taken into account, given the vast number of people who would want to ensure that this hormone is not in their milk, so it is not as simple as that.
I want to ask you about the JECFA. Who appoints the JECFA? Is it through the United Nations process? Does industry have a role?
I understand that the Codex Alimentarius Commission is made up 90 per cent by pharmaceutical representatives, along with food industry representatives.
Mr. McLean: First, I should again attempt to dissociate JECFA from Codex. That is terribly important because JECFA has as much trouble with Codex as you people do. We are constantly having difficulties with their findings and the Codex process.
As far as the appointment of people to JECFA is concerned when one becomes necessary, the JECFA secretariat canvasses the nomination of various people and then the credentials of those individuals are checked by the JECFA secretariat and an appointment is made. The appointments are actually for that particular meeting, and you may not be invited to the next meeting or subsequent meetings. Your continued appointment is very much dependent on the requirement for your expertise and your contribution at the previous meeting or meetings.
Senator Spivak: You are a permanent chair.
Mr. McLean: No, I am not a permanent chair. I am the longest-serving chairman of JECFA, but I am subject to election before each meeting.
Senator Spivak: I want to get into the research area, to the extent that I can. According to the gaps report, the antibodies in the rats to rBST were detected in that 90-day oral study. The impact of that was not necessarily to say it is not safe, but the clinical significance of the development of such antibodies following long-term exposure remains to be elucidated.
There have been no long-term exposure studies done on this particular drug because Monsanto based its findings on this 90-day rat study. If there had been a huge, long-term study, I am sure we would have heard about it by now.
Mr. McLean: There is one huge, long-term study in humans that has been going on for a number of years. One American pharmaceutical company next year hopes to sell $200 million worth of human growth hormone that will be injected into humans. That is the one that is biologically active. Bovine growth hormone is not biologically active in humans.
Senator Spivak: Yes, it is.
Mr. McLean: The only response you might get is an immune response to food, which many people get. Allergies to food, or immune responses to foreign proteins, are not uncommon after ingestion of a particular protein, but it generally wanes. That is the sort of thing you saw in the rat study.
Senator Spivak: What about the effect of a hormone-mimicking chemical on reproductive and endocrinological systems? From what I gather, that area was not examined. That whole area is not an old concern for scientists; study on the effects of these hormone-mimicking chemicals is a more recent area of interest. Is that not accurate?
Mr. McLean: The endocrine disruptors are relatively common. With regard to the response that BST elicits in animals of increasing the levels of insulin-like growth factor, we should not forget that, in normal pregnancy in humans, that can go up by 10-fold. Therefore, I do not believe that this is an issue that should be confused with endocrine disruption. While you are sitting here, the amount of IGF that you have in the system, which is probably the most significantly biologically active component of this whole chain of treatment, is so great, and the amount that you would take in in the milk from treated animals is so small, between zero extra and a very small amount, that it is probably insignificant. Eventually, you are searching for the Holy Grail. There is no evidence at this stage that IGF will influence that process. Perhaps my endocrinologist colleague might like to say something.
Senator Spivak: Let me clarify what I am asking. I understand, from the brief reading I have done, that the chemical hormone is a different kettle of fish altogether from the normal hormone, and that a very minute trace of it at certain periods of gestation, according to a researcher who started much of this study, can be quite disruptive. They are beginning to examine this seriously. It has not been really examined before.
You need not go into this any further. I understand that this has not been studied, including in your study, and I understand your explanation.
Turning to the mastitis and the increased use of antibiotics, even the Monsanto label warns about all the things that can go wrong with cows using their product. Were you at all interested in studying the effects of the increased use of antibiotics in animals? Again, were any long-term studies done through lactation and so forth? The point here is that normally, as you are well aware, under our Food and Drugs Act, nothing would be accepted without those long-term studies, and here it appears they were not done. What is the basis on which you made your decision? Were they as a result of long-term or short-term studies?
Mr. McLean: Are you talking about the antibiotic issue?
Senator Spivak: I am talking about the antibiotics and the mastitis issues.
Mr. McLean: We only studied the level of antibiotics as it might relate to food. The latest information we have is a surveillance program that the United States has on antibiotic residues as far as processing of milk is concerned. Except for one period of one-quarter of a year where there was a very small increase, it showed no change in the number of antibiotic residues before BST was introduced and in the years after. I have the data, if you are interested, but it was quite a detailed survey to monitor exactly this.
Senator Spivak: That would be interesting.
Dr. McLeod, this is an important issue for us because we are looking at the impact of industry on this whole food protection process. I know one of the members of your panel was a consultant to Monsanto. Personally, have you, or has any member of your family, worked for or consulted for Monsanto or any other pharmaceutical company?
Mr. McLeod: Speaking for myself, I have been a clinical pharmacologist in Canada for 25 years, so I have worked at one time or another with most of the pharmaceutical companies in the country, just as I have worked with most levels of government. I have been on several federal government committees. I have been on committees for the World Health Organization and so forth. Personally, I have worked with, I would say, the majority of drug companies.
Senator Spivak: Have you been a consultant for Monsanto at any time on a paid basis?
Mr. McLeod: No. I have never worked as a consultant for Monsanto.
Senator Spivak: Has any member of your family?
Mr. McLeod: I declared, before I took on the chairmanship of this committee, that my wife worked for 15 years for Searle Canada, which was not a subsidiary of Monsanto when she started working there but which became wholly-owned and operated by Monsanto somewhere along the way. I was not sure whether that constituted a conflict of interest or not. I was assured it did not. She left Searle Canada in December, 1997.
Senator Spivak: Thank you for clarifying that. I know that there is another member of your committee who indeed had worked as a consultant for Monsanto, and that was deemed to be fine.
I want to get on to how you are examining this issue. Will you get the 90-day rat study raw data and examine it in the way that the scientists did in the gaps review?
This is a bit confusing because it is like asking who is watching the guardians. How will this balance out? Will your opinion be deemed to be superior to that of the scientists in the department? Will you do these long-term studies on the data?
Briefly tell me what sort of summaries and studies you are examining. We have a list, but there is no gap analysis on it.
Mr. McLeod: You have the list of what we were sent by Health Canada originally back in May, I believe. Since then we have looked at literally hundreds of other items.
I should like to say something about the focus I perceive around the table on the use of raw data. My experience is totally with the evaluation of drugs for human use, but when any manufacturer makes a submission about such a product, they submit hundreds of thousands of pages of data to support their submission. I do not think anyone in my position out in the academic world would knowingly take on the job of reviewing such a submission for Health Canada. That is not our job.
It certainly never occurred to our committee that they might be expected to look at the Monsanto submission. We were asked, in fact, to reflect on the same issues that have been raised by the internal review team -- what you are calling the "gaps analysis." We identified very much the same issues in our review of the information that was available. Those are the issues that we will address in our final report. To date, we think the 90-day Monsanto study showing antibody formation is relatively clear. Our committee as of last week did not feel the need to see the raw data. We do not dispute that study. There are problems with it, as Dr. McLean has already said. It is dealing with an extraordinarily high dose of rBST given to rats.
Senator Spivak: You can understand the reason for the focus. That study was misreported in the first place. Completely contrary results were given. I am only going on the data we have from the gaps report. That is the reason for my concern.
Mr. McLeod: We share your concern about that.
Senator Spivak: My next question is for Dr. Morin. This is a permanent scientific advisory council. Will you be reviewing the work of the external committees? Where will the buck stop on this?
Dr. Yves Morin, Vice-Chair, Science Advisory Board, Health Canada: As you know, the Science Advisory Board has been established now for a year. Senator Wilbert Keon sits on that board.
Senator Spivak: Yes. We are very proud of Senator Keon.
Mr. Morin: As are we. Over the last year, we have reviewed the scientific and technical adequacy of the Health Protection Branch. We have met with scientists, we have visited their labs, we have looked over their work. I strongly believe that the science in those labs is of the highest quality and that these scientists are strongly motivated.
We also, over the last year, reviewed most, if not all, of the programs of the branch with the managers.
I should like to come back to what was said earlier this morning. I strongly believe that Canadians at present are well protected against present and emerging health risks. That is very important to state, in spite of what is being said.
In the course of the review of these programs, we have made a number of recommendations. I have been impressed over the last year by the openness and cooperation of the management, and by their enthusiasm in implementing these various changes.
We did not deal specifically with rBST. We reviewed generally the process, and I think we are satisfied. This is very important because there is a danger in destroying what is functioning well at the present time.
As a practising clinician now for many years, I feel our record in Canada is excellent. We have good drugs. Canadians are healthy. There have been problems but generally the HPB has done a very good job. In the future, there are plans to improve, and that has been expressed here.
On the whole, the department is doing a good job and there is no reason to be alarmed or worried that our food or drugs are not safe. That is very important.
Senator Spivak: I am glad you made that statement. There will be changes in the area of cost recovery, and while this may not be exactly within your expertise, I would appreciate your opinion.In January, the New England Journal of Medicine raised the issue of scientists who receive money from industry and so forth. We have all heard of the Dr. Olivieri case. This is a very important issue. I would be interested in your views as to how that process could be safeguarded from abuse.
Mr. Morin: I appreciate your concern, senator. You are quite right; it is an issue. People are worried about that. It is very important for the process to be independent. Explicit safeguards should be put in place.
Mr. Dodge alluded to this earlier. Our board has already expressed the view that the process should be as transparent as possible, with stakeholders being involved in all parts of the process. I might say that the FDA in the United States is starting on exactly the same process.
Senator Spivak: They are starting to put safeguards in place?
Mr. Morin: They are putting in safeguards, providing more transparency and having the stakeholders involved sooner in the process at all stages.
Senator Spivak: Did you say you did not really examine the rBST issue, but that you looked at it briefly?
Mr. Morin: Our job here is to look at the process. I remember posing a question about it myself and being told that no final decision was taken. We were satisfied with the fact that external boards are looking at it and that no final decision has been taken.
Senator Spivak: Thank you.
Senator Fairbairn: Dr. Morin, you will be making a report or recommendation of your own concerning possible changes to the health protection branch, is that correct?
Mr. Morin: Yes. We have made a number of recommendations up to now, on the primate colony, for example. A number of changes have been made to the food program. We will be making a number of recommendations to improve the Health Protection Branch.
Senator Fairbairn: This is ongoing? There is no single report?
Mr. Morin: No, we are making a number of recommendations. I might state that there are four principles on which we try to base all our recommendations. We have heard the concerns on your part this morning.
The first basis is that the health and safety of Canadians, and not economy, should be the prime mover in all these operations.
Second, we feel that science should be strengthened. There should be more external evaluations, peer review. The science is excellent but it can be improved anywhere, and I think that the science within the branch should be as good as it is anywhere else, in universities or in industry. I think we should have top-notch science.
Third, as I said earlier, the process should be as transparent and as open as possible, with consumers involved at earlier stages of the process.
Mr. Shugart alluded earlier to the fourth basis, which is the precautionary principle expressed so clearly by Justice Krever in his report. That principle should be at the basis of all of our operations.
Those are the four principles on which we base our judgments and recommendations.
Senator Fairbairn: Thank you for stating those because they are of particular interest to us, especially your last point regarding Justice Krever.
To follow up on a question of Senator Spivak's, from your work over the last year -- and it must have been done at a fairly intense pace -- have you any concerns about the scientific activity within the health branch?
Mr. Morin: No, on the contrary. You are reading all of this in the press. I expected far more problems than I actually met.
We have met, as I said, with many scientists in their labs. It is actually touching to see all these people and how strongly they feel and express their desire to safeguard the health and safety of Canadians. They express this openly.
Of course they have problems; of course they would like to have more resources. They would like to see improvements within their labs and their department. That is normal. However, there is no doubt that they are strongly motivated and that the research that is done is excellent. There is no doubt in my mind about that.
Senator Fairbairn: Mr. Shugart, you have come from another area within the government because of your work in the areas of transition and management processes. Perhaps you could give us a little snapshot of what you bring to this particular review.
Mr. Shugart: I certainly do not bring scientific expertise, although in my previous assignment as Executive Director of the Medical Research Council, I was closely involved in science policy. My training is in political economy and public administration, not in science. However, in that previous responsibility, I had daily access to Canada's scientists and some top-flight international scientists. Since we are talking about absorption to some extent this morning, one cannot help absorbing a great deal from that experience.
At the Medical Research Council, we did introduce some significant strategic change, both for ourselves and the other granting councils. We spent a considerable amount of time, for example, in the tri-council project on the ethics of research in human subjects. A number of areas to which I had previous exposure are very relevant to this task. I have spent some considerable time in health policy generally.
What I brought to this exercise, at the invitation of Dr. Losos, was a keen sense of the importance of the work that the Health Protection Branch has done and, most importantly, the opportunity to be engaged full time in this task.
I think it could be said without contradiction that the ADM responsible for health protection occupies one of the most significant and difficult jobs in the federal government, by the very nature of the task. To ask that individual to be responsible on a day-to-day basis with a renewal process, as well as to give close attention to the individual files that come across his or her desk, would be setting a superhuman task. Hence, the department made the decision that an ADM should be brought in on an assignment to lead that process, under his direction. That is the main thing that I bring.
We have spent a considerable amount of time engaging our professional and scientific staff in the process. We have endeavoured to be as open with the Science Advisory Board as possible, and it is that opportunity to devote attention full time to the task that I think is most important.
Senator Fairbairn: You made a point in your comments of drawing to our attention the fact that when you are talking about issues involving risk management, you are not necessarily talking about deregulation. You also talked about a review of 12 pieces of legislation. Are these legislative measures solely within the Department of Health, or do they involve other departments, such as the Department of Justice?
Mr. Shugart: I think the Department of Justice has, or would have, a keen interest in some of the issues. For example, we administer the legislation that deals with illicit street drugs.
This question of incorporating into the decision-making process socio-ethical and cultural issues likewise is of considerable concern across government. I would think that the Department of Justice would have a keen interest in that.
One piece of legislation that we administer with another agency is the Canadian Environmental Protection Act. Our professionals and scientists essentially act as the health adviser for the review of potential environmental contaminants and new substances. With respect to the Food Inspection Agency Act, the Minister of Health is clearly designated as the minister responsible for establishing policy and setting standards, while the Minister of Agriculture is responsible for the functioning of the inspection system. Those are two examples of our work that touch other departments directly.
Senator Fairbairn: With regard to the Department of Justice, protections under the Criminal Code are involved there. In terms of responsibility, would there be any inclination to weaken any of the protections we currently have within the Criminal Code?
Mr. Shugart: I assume you are referring to health protection policies in general.
The suggestion has been made that this process is a smokescreen for removing health protection from under the criminal powers. I can make it absolutely clear to you, on the record, that that is not the intention.
Health protection legislation, historically, has derived from the criminal law power of the Government of Canada, and the technical language is "to prevent a public evil." It is on that basis that the general prohibition against marketing any substance that would do harm finds expression in our health protection legislation. That will not change.
It is true that in some areas we are examining the notion of adding civil remedies to that traditional criminal power. However, when we talk, for example, of the ability to add the power of a mandatory recall, as Justice Krever recommended in his report, or to engage in alternative dispute resolution, we are speaking of adding to our capabilities certain civil remedies which we do not now have. We in no way are even remotely contemplating removing health protection legislation from the criminal power.
Senator Chalifoux: I am not a scientist but I am a consumer, and this is where my concern lies. I read of studies such as those from Washington DC, from the Cancer Prevention Coalition and others, which conclude that milk from cows injected with BGH increases risks of breast and colon cancers in humans. Since 1986, independent scientists have expressed concern about the lack of research on the potential health effects of IGF-1 in BGH milk. More recently, the Council of Scientific Affairs of the American Medical Association admitted that further studies will be required to determine whether the ingestion of higher than normal concentrations of bovine IGF-1 is safe.
There is another report from London, England. It is from the Global Policy and Campaigns Unit of Consumers International. It states in the overview that Consumers International strongly opposes the adoption of the draft maximum residue limit, MRL, for bovine somatotrophin. Consumers International and, indeed, the majority of consumers and consumer organizations worldwide, are concerned about the approval and use of bovine somatotrophins, also called rBST.
I am not sure whether this question is better answered by Dr. Losos or Dr. McLeod. Canadians have always had a high regard for your department and have trusted it. I have felt the same way. As most of us are not scientists, we must put our trust and faith in your department. I have some strong concerns about this. Are you doing any research on this?
Mr. Losos: No, we are not doing in-house research. We invited these scientists to show you the mechanisms we have in place to challenge the same areas in which you have concerns. Unless those questions are answered, this drug will not be approved.
Senator Chalifoux: I have your guarantee on that?
Mr. Losos: Those questions must be answered. Senator Spivak asked earlier: Where does the buck stop? The buck stops with the department. These are advisory bodies. JECFA deliberates but, ultimately, the department must make the decision. We must weigh all of these things and see how many gaps like that remain.
Mr. McLeod: Senator Whelan said earlier that it is hard to prove that something does not happen. That is true. However, that is the basis of the scientific method. This sort of uncertainty is what scientists deal with all the time. Any scientific experiment starts with what is called the null hypothesis -- that is, a hypothesis that there is no difference. You prove that something is true by disproving the null hypothesis. We are always dealing with probabilities. We will never prove with 100 per cent certainty that rBST, or some of the other biological substances that result from the use of rBST, are absolutely safe. It cannot be done. If that is the standard that we have to achieve, there is no point in starting. We must deal with what science always deals with: probabilities. That is certainly what the human safety panel will do.
Mr. McLean: When JECFA carried out its second review this year, it had all that data. The data come from the observation in humans that pituitary giants, or acromegalics, have an increased level of human growth hormone circulating in their plasma, with a consequential increase of IGF-1, and that that may be associated with increased levels of cancer in some of these people. We explored that issue. The levels that you get in milk are significantly lower than you would get in those patients, who very often have a tumour of the pituitary gland. One of the members of the committee that examined that was our representative from Consumers International. I believe he was satisfied with the data that we examined and the way we reported.
Senator Chalifoux: You are telling me, then, that this research has been done and that you have proven that the concern is not valid?
Mr. McLean: With one qualification, in that my colleague here said that it is extremely difficult to prove the null hypothesis. We were saying that the observations that had been made regarding people with pituitary tumours and other problems was valid, but that it did not apply in an extrapolation to the consumption of milk from cows that had been treated with bovine growth hormone.
Senator Fairbairn: I gather from the comments both of you have made that you have not felt constrained to examine only the material that has been sent to you, but that you have been free to go beyond that in your studies. Are you due to report later this month? If so, do you believe that you and your colleagues have had sufficient time to do this review?
Mr. McLeod: In answer to your first question, certainly my committee has not felt in any way constrained by the data that was available from Health Canada or which was in the original Monsanto submission. In fact, much of that information is now of largely historical interest. The science has moved on, particularly in these areas that are most controversial, the ones to which Senator Chalifoux referred. We are looking at the scientific literature as it unfolds. Believe me, it unfolds very rapidly. There were approximately 1,000 papers in the last 12 months dealing with the subject of IGF-1 alone. You can multiply that number for growth hormone, and so on. We will look at any information we can find. We will ask for any information we think might reasonably be obtained from Health Canada or from the sponsor of the product.
Beyond that, when will our report appear? Originally, we were supposed to report on July 31, but we were not really organized until May. We are now expecting to have a draft report by the end of November and, I hope, a final report by the new year.
Senator Fairbairn: Could I also get an answer to that from Dr. Dohoo?
Mr. Dohoo: Essentially, the same conditions apply to our panel. We have not felt at all constrained to examine only Monsanto's submission provided through Health Canada. We have looked at other information that is available, in particular in the published literature.
On the animal health side, it is also true that the information is voluminous and we have done the best we can.
We also had the target deadline of the end of October. Since that is two days from now, no, we will not make that date. We hope to have a report submitted during the month of November. We are now in the process of editing and coming to final conclusions with the panel, and the date for reporting will depend on how extensive those discussions are. I cannot predict exactly what that date will be.
Your other question related to whether we have had adequate time. There is always a balance. If we reported in October of 1999, we could do a more thorough review, we could look at more information and have newer information because another year would pass. We are trying to balance the need to respond in a timely manner with the need to respond in a thorough manner.
The Chairman: Thank you. I wish to thank Dr. McLeod for appearing.
[Translation]
Senator Robichaud: You said that you were going to examine all of the data on this growth hormone and on its effects. Last week, we heard some people who said that there was not enough data to make a detailed study on the effects of this hormone both on animals and on humans. Can you tell me whether there is sufficient data? If not, have you started research to find the missing data?
Mr. Shugart: Normally, we would ask the manufacturer of the product for additional data. We want to identify the needed data that we are missing now. Our job is to provide the additional knowledge and to make sure that there are no gaps in the research made to date. And that has to be done before any decision is made about the product.
Mr. Morin: The HPB is not doing any specific research on this product. A study was done at the HPB. Two panels are now examining the safety issue, one for animal health and the other for human health which Dr. McLeod is chairing. These two panels as well as HPB scientists will examine all data. To answer your particular question, there is no research or study being conducted at the HPB.
Senator Robichaud: I wanted to know whether there was enough material on this hormone to make a full assessment.
Mr. Morin: The panels have yet to submit their reports. It is a bit early to say. It might be that both panels will determine that more data is needed. The panels were struck last February and should submit their reports early next year. You cannot prejudge their findings but, as you say, it might very well be that the panels will determine additional studies are required.
Mr. Shugart: It is precisely because Dr. Losos was not satisfied with the results up to now that he asked for two science panels to be struck.
Senator Robichaud: Were people saying that clearly there was insufficient data?
Mr. Morin: I am not an expert in this field. You cannot prejudge the results of the panels. Dr. Dohoo is here and could answer your question.
[English]
Mr. Dohoo: Part of the mandate of our committee, and I believe of the human health panel, is that we have two parts to the mandate. One part is to make a judgment about whether there are health affects. The other part is to draw a conclusion as to whether there are adequate data. In our case, on the animal safety side, we are looking at many possible outcomes. Some have been mentioned here today, mastitis is one, but there are many others. We may well find that we feel there is adequate data in some areas and not in others, but we will be addressing that in our report.
Senator Robichaud: This is the assurance I want.
[Translation]
That if there is not enough data, every effort be made to get them either from the manufacturer or through other means to ensure the integrity of the process.
Mr. Morin: We wholly share your concern.
[English]
Senator Whelan: I wish to ask a question that concerns the testing referred to by Dr. McLean, who mentioned the stomach tubing of rats and their tolerance being limited. It has been brought to our attention that there should have been longer tests done, there should have been tests done on different species, and we have had 10 years to do that. We have not done that. Does anyone wish to tell me why?
Mr. McLean: Whilst there are suggested protocols laid down for toxicological testing, if questions can be answered or reasons given why further studies are not necessary, then the practice is not to slavishly do the tests if they are not necessary. A large number of compounds are registered without a full battery of tests that are required for some other compounds. Toxicology is a science that has a degree of variability to it, and you perform the tests required to demonstrate safety.
The other problem which you have is you do not embark on these tests lightly. For example, a multi-generation reproduction study could be worth $5 million. A two-year carcinogenistic study could be $2 million. If the questions can be answered from data in another way that shows that those tests are not required, or you have answers that suggest that they are not necessary, then they are not always done.
Senator Whelan: There are enough suspect statements made about incomplete tests on different species. A 90-day test for Monsanto is not unreasonable when you consider the amount of money they spend on lobbying. I lobbied against them, I was probably the only paid lobbyist against them, and I did not get very much money either, and I was successful in holding them up for approximately seven years. They would have been much better off if they had spent more money on doing the testing.
Earlier Dr. Yves Morin and I were talking and it was suggested that I am against biotechnology. I wish to make it clear here that nobody advanced more in modern biotechnology in agriculture than I did in the 11 years that I was minister. We built more research and we had a bigger research budget than any other department.
I wish to set the record straight because someone must have told Dr. Morin to watch out for me because I am against biotechnology. That is a lie. I wish to make that plain and clear. The suspicion is there and I put the suspicion again, to you, Dr. Losos. I have the record here of all the information that was withheld from us in the committee, reams of information that you refused to give to this committee which caused delays. We asked for the information last June and we did not get it until two weeks ago. What is the public to do when that kind of information is withheld?
You are from Australia and you probably do not know about things like that, but I wish to inquire of you, Dr. McLean, were you ever a politician?
Mr. McLean: No.
Senator Whelan: You could have been a superior one with the answers you have provided. Both the head of the school of veterinary medicine and you are appearing with the other group of the surgeons. Put yourself in our position of representing the public. We receive conflicting information from England, Europe, the United States and elsewhere, and they are divided on what we should be doing. The European scientists, for instance, cannot be all that bad. They claim there are trade restrictions. I know some of them and I do not believe that these are just trade restrictions.
Dr. McLean, you made the statement that even the Australian decision was made partially on trade considerations.
Mr. McLean: Mr. Chairman, we have a requirement in our registration legislation to consider trade issues, and because BST is not registered in countries where we trade, then the decision has been taken to wait for those countries to make a decision before we proceed with registration any further. It is a legislative requirement that cannot be undone.
I will go on and just answer a question about an issue that I believe is important. If you look at BST then, first of all, the BST that is injected into the cow is not active in humans.
It is an irrefutable fact that in the 1950s and 1960s, thousands of doses of bovine pituitary gland extract were injected into humans to try to encourage shorter children to grow properly. That was ineffective. Therefore, we know that bovine growth hormone does not enhance the growth of humans or interfere with the metabolism in any way.
The issue revolves around the administering of BST to cattle and that is an increase in IGF. The trials are variable and show that the increase in IGF overlaps the natural range that occurs in untreated animals. Therefore, for those two reasons, some regulatory authorities have deemed that it is not necessary to do any further testing.
I am not coming down on one side or the other. I am presenting you with the argument that has been presented to regulatory bodies in other countries and in international bodies in making the decision.
Senator Whelan: Turning to Mr. Dohoo, are you not concerned when you see reaction results of some cattle? Not all animals react the same way to chemicals. Some cattle do not even give more milk and do not respond to the injection of the hormone. Were you not concerned when you read the evidence of the big spots appearing on the cow's and their hair falling out that the Humane Society might get involved?
Mr. Dohoo: The job of our panel is to determine if there are adverse health affects associated with the use of the product and to determine, if there are adverse effects, what other procedures could be put in place to eliminate those affects. We will be addressing those.
When I started talking with the CVMA about the formation of the panel, our mandate specifically referred to the efficacy of the drug in animals and animal safety. I felt quite strongly that animal welfare needed to be included in that consideration because animal welfare is one of the mandates of the Canadian Veterinary Medical Association. I was assured, through Health Canada, that animal welfare was a component of the safety issue. Our panel is concerned about those issues and we will be looking at those.
Senator Stratton: I would like to return to the issue of the internal rBST review executive summary of June 10. In that executive summary, on page 3, last sentence, it states that because rBST is considered biologically indistinguishable from naturally occurring bovine growth hormone and because bovine growth hormone shows limited binding affinity to the human growth hormone receptor, the usually required toxicity tests such as chronic exposure studies, carcinogenicity and fertility reproduction studies were deemed not to be necessary.
In the executive summary, on page six, the question is asked in the last bullet at the bottom of that page, if the total rBST content of milk or milk products or meat derived from rBST-treated cows increased above levels from non-rBST-treated cows. The answer is overall measurable BGH content of milk varies depending on animal age, health and location and is not considered to be elevated outside normal ranges by rBST treatment. Furthermore, 85 to 90 per cent of immunoreactive rBST is destroyed by pasteurization.
Once this product is used in cows, the milk is then taken and pasteurized. It says in the executive summary that 85 to 90 per cent is destroyed by pasteurization; is that true.
Mr. McLean: Yes, that is correct. About 50 per cent of immunoreactive rBST is destroyed in the temperatures used to make infant milk formulae.
Senator Whelan: A point of information. The tests were way higher and held at a higher temperature much stronger than for normal pasteurization and 99 per cent of the milk would not be affected by that test.
Mr. McLean: I do not deny that. I just pointed out that it is not destroyed.
Senator Stratton: My concern with IGF-1 is that if we are testing these products we take it to a much higher level than would normally be absorbed by a human being. How do we measure the significance of the higher testing levels to normal consumption that would occur?
How do you rationalize the two when you have significantly higher than normal consumption levels? When is the danger signal triggered, or are they?
Mr. McLean: Normally the levels of insulin growth, IGF in milk, sit around four nanograms, let us say four units. When you treat with rBST, you get a variable response. In some situations, you have very little increase, in others you have a larger increase but a very conservative worst-case scenario for the purposes of calculation is an increase to about six units.
If you go from four to six, in other words you have another two, that gives you 2,000 units in a litre of milk. The total human production in a day is about 10 million units. Therefore, you are adding 2,000 to 10 million. My belief is that if you do a risk analysis, what risk are we looking at? As this is a naturally occurring substance, then the increased risk is close to zero. That is the first thing.
The second thing is that if you wanted to regulate, you cannot tell the difference between treated milk and untreated milk, as far as IGF is concerned, because the normal ranges and the treated range overlap considerably.
When we are looking at children, for example, human milk contains 5 to 10 units; human cholesterol, 8 to 28 units; bovine milk, 1 to 9 units; and treated milk, 1 to 13 units. We are now swimming in a sea of insulin-like growth factor to which you have added a drop.
Senator Mahovlich: Are Australian standards for baby formula at the same temperature standards in Canada?
Mr. McLean: I cannot answer that question except that the companies that produce infant formula in Australia are the same companies that I see on supermarket shelves here. Therefore, the process is likely more or less internationalized. I do not think Australian milk is any stronger or weaker than Canadian or American milk.
Senator Rossiter: I wish to direct my question about animal safety to Mr. Dohoo. Is it correct that a cow treated with rBST is no good after two or three lactations?
Mr. Dohoo: There has been discussion about that in the literature. I cannot answer the question, but I can tell you that the panel is looking at the impact of the use of the product on culling or risk of removal from the herd. If a cow is not effective following treatment, she will be more likely to be removed.
Senator Rossiter: If that is the best you can get out of a cow, it is not economical. First, you have the extra feed to product a questionable amount of increased milk, plus the turnover in the herd. You would not be inclined to use a highly pedigreed cow in that situation.
Mr. Dohoo: You have raised many important issues. Any dairyman faced with making a decision about using the product would need to address those questions. We will be addressing some of them, but I do want to point out one that we will not be addressing.
We will be looking at what impact this product has on dietary requirements or feed intake in these cattle. We will also look at the effect on longevity or risk of removal or culling in these animals. However, we are not in a position to do an economic analysis as to whether it is ultimately worthwhile. One of the factors that would influence that is for what price the company sold the product. We have no idea what that would be. It is not within our mandate to do an economic analysis.
Senator Rossiter: The other question remains about the possibility of the increased incidence of mastitis and, therefore, the increased use of antibiotics, which can come down through the chain to humans.
Mr. Dohoo: We will be looking at that and trying to determine our best estimate to whether there is an increased risk of mastitis associated with the product. If so, how big an increased risk is it? Is it something of substantial consequence that we need to be concerned about, or is it very small? We will also be addressing that question. I am afraid that I cannot tell you the answers to those questions yet.
The one point I wanted to reiterate related to last week's testimony from Mr. Blois from the dairy producers. There are serious consequences for producers who let antibiotic residues enter into the food chain now. In addition to the penalties associated with being detected, if the truckload of milk is found to have residues, they must pay for the whole truckload.
Senator Spivak: What about meat, though?
Mr. Dohoo: I have not seen specific discussions about potential residues in meat. That probably falls within the mandate of the human panel to determine if residues would have a human health consequence.
Senator Rossiter: We are talking about residues of the antibiotics, not rBST.
Senator Spivak: Yes.
Mr. Dohoo: There are withdrawal times both for milk and meat following the antibiotic treatment of cattle. Procedures are also in place at slaughter houses to monitor for antibiotic residues in meat. In general it would be fair to say that there is a greater concern within the dairy industry about the possibility of residues being in the milk because milk is shipped from treated cows. That is much more likely to happen than the off-chance that a cow gets culled and shipped for slaughter a short period of time after treatment.
Senator Spivak: I do not want my esteemed colleague to leave the wrong impression with the June executive summary because on the front page of the summary from which he quoted, it says:
On a scientific basis, the main flaw in the HSD evaluations was that the conclusions regarding human safety were based on the assumption that neither BST nor IGF-1 possess any biological activity when administered orally and, therefore, present no hazard to human health. Data presented in the submission, as well as information available in the published literature at the time the submission was filed, indicated that this assumption was not necessarily correct under all circumstances.
Under the scientific analysis, they identified the gaps. One of them was the potential effects of IGF-1. In particular, the neonate, the sub-population greatest at risk, was never explored.
I also want to quote from the executive summary as to whether rBST is structurally unique compared to naturally occurring bovine pituitary rBST. It states that:
The recombinant structures are distinct chemically and therefore there may be subtle immunoreactives in the metabolic differences which have not been reported because they were never investigated.
I should like to ask some questions of Dr. Losos. If they cannot all be answered here, the doctor can get back to me.
How many scientists in the recent restructuring were cut from the Health Safety Division?
Dr. Morin raised the issue of the precautionary principle. Canada is a signatory to the biodiversity convention, which binds it to utilize the precautionary principle. If that is the case, then the attitude towards the approval of drugs is very different because the precautionary principle says you err on the side of caution. You do not have to prove that the drug is unsafe; you must have some indication that it might be unsafe. In other words, it is up to someone else to prove that it is safe.
I also want to know about the Codex Alimentarius. The representatives at the meetings of the Codex Alimentarius were not in favour of further studies. They voted against it. At the same time, we were evaluating rBST in Canada. My understanding of the Codex Alimentarius decisions is that while they may necessarily be binding, they can be used in dispute settlement mechanisms. If the Codex Alimentarius, for example, says that rBST is perfectly safe and should be used forthwith, and then Canada decides not to use it, then Monsanto can sue the Canadian government for loss of profit, as has already happened with Ethyl Corp. and the MMT issue. Is this assumption correct? What is your view of the Codex Alimentarius?
Mr. Losos: Codex is not binding.
I should like to ask Dr. Paterson to come up to the table because he will address the number of cuts on the human safety side. I will, however, comment on the precautionary principle.
We have an intensive program to implement all of Justice Krever's recommendations with an investment in the branch on the regulatory and surveillance side as far as blood safety is concerned. How we manage in and around the precautionary principle is of very great importance to us.
We had a large-scale staff meeting where we invited Justice Krever to talk to us and discuss how we could adjust our programs to specifically address and embody the precautionary principle. It has implications on policy and on organizational structure eventually, as that is the way that we will be moving. We do not have a final answer as to how that precautionary principle will work.
I recently returned from the European Union, and they are in the same position. Everyone has similar issues with respect to health and safety, health protection and public health in general. That precautionary principle will be the subject of a SWAT team of experts over the next number of months to work out a road map as to how that precautionary principle will apply to our programs from an operational sense.
I will ask Dr. Patterson to address the other question about Codex.
Mr. Paterson: I believe the first question was about cuts.
Senator Spivak: How many scientists have been cut in the Health Safety Division?
Mr. Paterson: In terms of the food program, there were meant to be 120 reductions. In actual fact, the minister took two steps last year. First, he imposed the moratorium. About a month after that he reinstated it because most of the cuts, if not all of them, were in the research area. A simplistic answer is that there have been no cuts.
Senator Spivak: Good.
Mr. Paterson: In actual fact, though, because of people making decisions to leave or retire, we have actually lost about 10 people. We lost more than that, but through extraordinary measures, such as bringing in new scientists and technicians, we have come back to where we were. At the moment we are down about eight to 10 over what our numbers were before the cuts were announced.
Senator Spivak: Do you have a comment in regard to the Codex issue?
Mr. Paterson: On the Codex side, I do not have anything more to add than what Dr. Losos said. Codex is not binding. It is an international body to establish food standards, but no national body or government is bound to adopt the Codex standards.
However, through the World Trade Organization process, in particular sanitary and phytosanitary standards, that body is, with respect to food standards, prepared to look at what comes out of the Codex process in terms of their appropriateness vis-à-vis international trading, particularly if there are disputes under the WTO. It is not insignificant, but a national government is not duty-bound to accept it.
Senator Spivak: Are you saying that if the Codex Alimentarius deems that rBST is safe for use and the Canadian government then chooses to say that it is not prepared to license rBST, then Monsanto has no basis on which to sue the government for lost profits and opportunities under the WTO process?
Mr. Paterson: Not being an international lawyer, I will be careful how I respond to that question.
As long as Canada, as a sovereign nation, had a justifiable rationale -- in other words, the health and safety risk assessment was rigorous and valid -- then, no, there would be no basis.
Senator Spivak: However, you will remember that the Government of Canada used the precautionary principle with MMT and it did not work. Obviously the precautionary principle would not be sufficient.
Senator Rossiter: That was not on human beings.
Mr. Paterson: Again, senator, we are getting into deep water. A significant amount of weight will go to precedent, as we are seeing through the WTO and the SPS process with respect to the issue of hormones. Cases will be brought, panels will be set, and jurisprudence will come out of the case precedents.
The Chairman: Perhaps Dr. Losos could give us a final statement.
Mr. Losos: I wish to explain myself with respect to Senator Spivak's question. I said that we invited Justice Krever to attend our planning workshop on the precautionary principle. I did not want to leave the Senate with the impression that Justice Krever came to it. He was not able to attend, and Mr. Justice Elliott, who was heavily involved in the Krever inquiry, came in his stead. We had a full discussion, but I do not wish the Senate to be misled.
Senator Spivak: I wish to express my thanks to the gentlemen here for spending so much time with us.
The Chairman: Do you have a closing statement Dr. Losos?
Mr. Losos: Not an extensive one, Mr. Chairman.
I requested to appear before this committee to demonstrate the integrity and depth of the review process, the many mechanisms and values that the branch espouses as far as review is concerned. The fact that these expert panels are in place in front of you is an example of the process in action.
I thank you for allowing us to appear today.
The Chairman: On behalf of the committee, I should like to thank Dr. McLean for coming from Australia. We appreciate his input, as well as the input given by Health Canada officials.
Honourable senators, our next witnesses are representatives from the National Farmers Union.
Mr. Peter Dowling, Ontario Coordinator, Member NFU National Executive, Dairy Farmer, Howe Island, Ontario, National Farmers Union: By way of introduction, the National Farmers Union welcomes this opportunity to meet with you today and bring the views of Canadian farmers on this critical issue.
The National Farmers Union is the only voluntary, direct membership national farm organization in Canada and the only one incorporated under a federal act of Parliament which was done in 1970. We are non-partisan and work towards the development of economic and social policies that will maintain the family farm as the basic food-producing unit in Canada.
The NFU believes that individual farmers must work collectively to assert their interests in the agricultural industry, one which is increasingly dominated by multi-billion dollar corporations.
I will give the committee some history of our involvement with rBST. In 1988, we adopted a position in support of a ban on BST.
Members were concerned about cow safety, farm-level economics and potential consumer rejection of the dairy products from cows injected with the non-therapeutic, performance-enhancing and synthetic growth hormone.
Since that time, our organization and its members have been actively monitoring the review of BST in Canada, as well as the experience with this product in other countries. We have become even more aware of the massive resistance to this product among Canadian farmers and consumers from coast to coast, and of the incontestable scientific, economic and humanitarian reasons for that resistance.
Scientific studies and consumer research over the past decade have confirmed the wisdom of our opposition to this product. The recent events and disclosures, stemming largely from the work of this committee, have further reinforced our position.
The NFU applauds and thanks the Senate for the motion it passed last May urging deferral of the licensing and the tremendous work done since that time by the senators and the committee bringing to light the facts involved.
In appearing before you today, we wish to outline for you the major issues as farmers see them, and the reasons why the NFU maintains its opposition to the use of BST in Canada. In the interest of time, we will highlight the main points and refer you to the written submission for details. This statement is submitted with two appendices. We will be glad to answer your questions upon the completion of our presentation.
Our first concern is that this is a threat to Canada's health and safety and the Canadian dairy industry. It puts at risk the health of Canadian people and it is a menace to the well-being of Canadian cows. It has also been borne out again and again over the past few weeks that it is destroying the public's trust in Health Canada and the Canadian regulatory system.
The main points we raise include the risks to the dairy industry. We point to strong and consistent consumer opposition, in the form of surveys, petitions, letters and post cards, that have been generated over the years. Another risk to the dairy industry includes a probable reduction in consumer demand. One Industry Canada survey said that one-third of consumers would say "no" to milk if BST were licensed in Canada.
There are also potential problems for producers and processors in the case of dual marketing. Our cooperative marketing system does not allow us the opportunity to meet the needs of dissenting consumers. It is quite an intrusive drug in that respect as well.
Risks to human health include the fact that rBST is a non-therapeutic drug which is unnecessary. It does not improve the milk or the cows. It does not have any nutritional attributes.
Studies point to rBST milk having higher levels of IGF-1. We cite those studies. IGF-1 is absorbed into the bloodstream and is associated with cancer. There is a need for long-term toxicology studies, which are normally required for non-therapeutic veterinary drugs.
In terms of risks to animal health, there are more than 20 harmful side effects listed on the label. Defining these as management problems blames the farmers. Farmers in the United States resent being called poor managers because of problems they have had as a result of using this drug. Farmers bear the cost of cows' illness and burnout.
I should now like to turn to the risks to trust in Health Canada and the regulatory process, which include the problem of undue influence of the pharmaceutical and chemical industries on Health Canada. Decisions must be made independent of the flawed United States approval process in light of new information available and allegations of improper process and pressure in the United States as well.
It appears that Health Canada scientists are being pressured to approve BST. Of concern as well is the Gaps Analysis Report, censorship and external review panels and the problems that we have with those. Canadians now know that we cannot trust Health Canada or rBST. There has been enough bad news reaching the Canadian public in the last few years about this product that the perception is that it cannot be trusted.
In conclusion, Canada currently produces sufficient milk to meet domestic demand. We do not need increased milk production. The drug rBST threatens to increase the Canadian milk supply while significantly reducing consumer demand. The result would be lower net farm incomes for dairy producers, a result they can ill afford. Farmers cannot afford rBST's damaging effects on the health of their cows.
Canadian consumers want pure milk. The drug rBST has the potential to destroy public confidence in milk, as the Mad Cow disaster did in England for beef, if it appears that milk from rBST-treated cows can cause cancer.
In summary, rBST harms cows. It erodes consumer confidence in dairy products, threatens to undermine our milk system and destroy farmers' incomes. It may cause cancer and other serious health problems in humans. Clearly, approving rBST would violate the imperative so aptly quoted by Senator Keon in the debate last spring: "Do no harm."
For all these reasons, the National Farmers Union urges that the federal government extend the ban on rBST indefinitely. Health Canada must be prepared to stand up to corporate interests and state that, because rBST is unwanted by consumers and farmers alike, it will not be approved.
We call on you and your Senate colleagues to recognize and represent the clear consensus of Canadians in opposition to rBST. We call on the Canadian government to keep this intrusive technology out of Canada.
I will now ask the other members of the delegation to make a brief statement before we proceed to questions.
Ms Lorraine Lapointe, Dairy Farmer, Martintown, Ontario, Past Director, Ontario Milk Marketing Board: Honourable senators, this morning I was quite upset that the first panel seemed to be very arrogant in providing you the proper information. They told you that they have been looking at this matter for eight or nine years. However, I have documentation from Health Canada dating from 1984, when experiments were being done in Ontario, Quebec, Alberta and British Columbia.
I requested that there be a public inquiry on the milk being sold from these herds in Ontario. I participated in that inquiry. Even though shredding has been going on at Health Canada, it does not matter. I have enough documentation, which I will provide to you, to indicate that the animal division of Health Canada states there is no human health problem. This was in 1984.
We have directors of the Bureau of Veterinary Drugs who wrote to Dr. John Burke of Guelph University about his concerns regarding safety in humans. The response to that letter from John Burke at Guelph University was, "Do not worry, John Price of Cyanamid Canada says there is no human problem. There is nothing there, so why be concerned about it?"
I was stunned to see that the answer from Health Canada on that issue was that it is safe for human consumption. Why was that being said when all along it has never been tested on the human side? We have Health Canada, the animal drug division saying, "There is no problem." On the human side they were saying, "Well, we have not done the tests yet."
You have only scratched the surface on this issue and other issues about how drugs are evaluated here. That is probably because it is the fast-track system that is being put in place.
I was disturbed by this in 1988 when it all came out.
It forced me to fight a battle. You could say I was fighting a battle for my children. I did not want my children or anyone else's children in Canada to be exposed to this.
When I started digging, I received many threats but it did not matter because this is very important, not just to human health but to the health of the dairy industry.
I have heard comments made about the dairy industry, that we are not efficient or that we cannot compete with the United States. That is not true. We are very competitive, in that we can market our milk in one pool in this country.
I have all the information that you need. I think you may not be asking the right questions about the rat test. Guelph University did do a rat test in 1989. That research was conducted on the bioactivity of milk from BST-treated cows. They used only male rats. I was absolutely disgusted when I read this and I called one of the researchers at the university and I asked, "What is happening here? They only used male rats." The researcher told me, "That is not the biggest problem. The biggest problem is that we had to use rats that had their pituitary glands removed." I asked, "Who made you do this?" The reply was that it was a directive from the pharmaceutical companies. Senators, you have only scratched the surface of what is going on here.
I have enough evidence to show that we had directors of the animal division saying that there is no human health hazard with the milk and the milk was being sold on the market from 1984 to 1988 in all these provinces.
Ms Joyce Hutchings, Dairy Farmer, Westport, Ontario, National Farmers Union: Honourable senators, I am proud to be a dairy farmer. Ours is a family farm. Our son and daughter have recently taken over the farm. There is no way that a growth hormone will ever be used on our farm. Even if it is approved and declared to be "safe" it will never be used on our farm.
The reason that I am so adamant about that is in October 1994, two of my colleagues and I drove down to New York state to visit a farm where they had been using Posilac. It was a herd of 200 or 300 cows. This farm was a picture when we drove in that day. The farmer knew we were coming. We found a beautiful dairy farm, a beautiful home, and a very exasperated farmer.
He took us on a tour through the barn. He talked for approximately two hours. As we walked through that barn, we could see that those cows that were left were thin, nothing like the cows that we left that morning at home.
His local vet had introduced him to Posilac at a seminar for local farmers. Most of the farmers took home enough to inject their cows. Before very long, problems were starting to show. Before we go any farther, this gentlemen, every month, got $3,000 extra for his milk because it was of top quality. At the time we were there, he was being fined $3,000 a month because of the high somatic cell count and underproduction. It was a scene that haunted me for months. Some of those cows had mastitis. They could not be treated because there was no drug available at that time to treat them for mastitis induced by the extra pressure on the system.
For other cows, their feet went bad. You should look at the list of warnings on the back of the Posilac, known as Nutrilac in Canada. Some of them, he said, dragged themselves around the barn for weeks. Fifty of his cows left one night on a big transport truck because they could not be made better. They were gone. He does not know where they went. He called Monsanto and they said, "It is poor management, sir." Poor management? This is a farmer who had top-quality milk with a $3,000 bonus every month and he is told he is using poor management and was fined $3,000. That is $6,000 less on his income.
Those cows were a sight to behold. We stayed there for approximately two hours. We took notes. We asked for and received permission to video the interview. Even today, I am haunted by the look of that gentlemen who almost lost his farm and his marriage, all for the sake of another 10 per cent increase in milk production.
Of the 30 or 35 farmers that took all these drugs home that night, only two were still using it. The farmer next door, who had many beautiful show cattle, would not talk about it to his neighbours. He was ashamed.
You now know why our farm will never use growth hormone. It is not necessary. If the government feels we need more milk, tell us. We are always over quota. Our cows will produce. With good management, you do not need a drug to make those cows milk. That is how strongly I feel. There are many efficient farmers in our area. They do not want it. The consumers do not want it. The processors do not want it. Who really wants it?
There has been much time and money spent on discussing this subject today for so few farmers. How many dairy farmers are there in Canada? Not many, compared to the money that is being spent on a product that we do not want and we do not need. We can produce the milk. We do not need a drug. Those cows do not need it, either.
Mr. Richard Lloyd, Manager, Ontario Office, National Farmers Union: Honourable senators, I have been mostly involved in research, passing information around. The one thing that has always struck me, though, is that there has been so little talk about the cows. It is quite an honour for us to be here today, as inexperienced and nervous as we are, to talk about the thing that this is all about.
Everyone can talk about JECFA, and so on, but it is very annoying to read the label. First, there was the American label that we read years ago, but now to give it a name like "Nutrilac"? It is insulting to read the label and then have the disclaimers that if you manage properly you will not have these problems.
We heard about Mrs. Hutchings' experience when she went to the states. You cannot maintain a management level of that skill all the time. Why would they introduce a product that is not curing anything, with those ramifications? Again, we repeat the list over and over. No one wants it. Why are we spending all this time and money on rBST? Why have I devoted 10 years of my life fighting this? Mrs. Lapointe and our organization have also devoted 10 years to this fight. It is clear to us that we do not need this.
I have seen all these officials from JECFA, and these world-wide bodies which have a significant amount of control. I appreciate Senator Whelan's insight into these matters. The power of the FDA is shocking. I would like us to be an independent country here and look after our interests, and especially our cows.
Senator Fairbairn: There are a number of us who, on reading the material that has been put together and, indeed, the gaps analysis, who have been deeply concerned about the effects that have been observed on cattle. I do not suppose anything has been as vividly portrayed or conveyed as your personal observations on this issue. There is a very strong concern on the part of committee members about the animal safety aspect of this as well.
This document certainly has information in it of which I have not been aware in terms of your list of quotations about the various people involved with Health Canada who, according to your document, have indicated that there was no problem with human safety.
I do not know whether you were here for this morning's testimony, but certainly the information we are now receiving in 1998 is that the reviews are not only ongoing but expanded, in terms of ensuring that no decision will be made unless this safety factor is believed to be sufficient.
Do you have any comments on the reviews that are currently being undertaken on this issue? Your comments certainly reflect those that we heard last week from the Dairy Council and of the Dairy Farmers. We will certainly be asking questions of other people about the information that you have in your brief.
Do you have views on the process that is currently underway in the health department, and the assurances that we have received from the minister, the deputy minister and so on, that there will be no decision made on this issue unless and until they are absolutely assured that this is not a health factor for humans and animals?
We know there is a physical problem with the animals.
Ms Lapointe: I should like to lead in that answer.
This morning it was indicated that one of the veterinarians on the reviewing panel comes from Quebec. Were any of the veterinarians on that panel involved in the experiments that were going on from 1984 to 1988 at any of the universities in Canada? That is one question that came to mind this morning. I wish to ensure that none of these veterinarians had anything to do with any of the experiments going on in these provinces from 1984 to 1988.
Mr. Lloyd: I have some fairly strong comments to make. I will start with my feelings about the development of the team at Health Canada, and the split into two reports of what initially were called external panels, and have now become expert panels.
In a nutshell, I see only ongoing cover-up happening here. First, when the scientists from within the department that had the expertise to do the review were given permission to do a gaps analysis report, two other eminent scientists were brought in. Why? They were not from within the department that contained that expertise. I believe they were brought in because the management wanted to have a report that did not show a consensus because the terms of reference of the external panels said initially that they would be set up because there was a lack of consensus within Health Canada. I saw a whole plan unfolding from very early on and it continued this morning.
This was, again, something we were aware of in 1994. I wish that I had brought the policy of the Canadian Veterinary Medical Association which I have in my files. It says in black and white that they think rBST is safe. It further states that if there are any animal health problems they are the responsibility of management. Of course they are, they are paid to do that.
These external panels are totally unnecessary. We had a report from scientists with Ph.D.s and 10 or 15 years of experience studying this who did a report. You cannot bring these people in. I now have that document.
It is a cover-up. I hope I am totally wrong, but I believe they will come in and say that it is fine.
Senator Spivak: Can we get a copy of that? Is that from the Canadian Veterinary Medical Association?
Mr. Lloyd: Yes, it is.
Mr. Dowling: To summarize, what we are hearing from senior officials at Health Canada, and what we actually see happening are inconsistent. It is difficult to build up confidence in the organization when there are these two different streams that seem to be in front of us all the time.
Senator Mahovlich: Do you have any idea when they started to study this particular product? You mentioned 1984 and 1989.
Mr. Lloyd: In Canada?
Senator Mahovlich: My experience with universities in the United States is that they study a certain chemical and they study it thoroughly before it is approved. I do not believe they would let it pass without that.Are we shadow boxing here?
Ms Lapointe: I have all the letters from Health Canada to the University of Guelph because of the public inquiry. All that had to be pulled for the public inquiry.
Senator Mahovlich: That is Guelph.
Ms Lapointe: Yes, but I am talking about experiments in Canada.
Senator Mahovlich: Yes, but I am referring to the United States. This must have been going on in the 1970s.
Ms Lapointe: That is not my problem. I am speaking as a Canadian and a mother. I have many problems with Health Canada stating that there were no human health problems with it, when the other arm of Health Canada was saying that they had not even looked at it. Do you not have a problem with that comment, namely, with officials stating that?
Senator Mahovlich: My point is that it is a world problem. If rBST is available in the United States, we will obtain it from across the border.
Ms Lapointe: I have no power to do anything about what is happening in the United States but I do here at home, I hope.
Mr. Lloyd: Senator Mahovlich, I heard similar comments from you last week, so I have brought for you some excellent summary pamphlets that were done by a group outlining what happened in the United States in the approval process.
You might be shocked to learn of some of the manipulations of data and people brought in from Monsanto to work at FDA in the key decision-making places. You will be shocked to read the story of the United States' experience.
Senator Spivak: May we all get copies of that?
Senator Fairbairn: In the second appendix to your presentation there are many references to various other exhibits. Are those available?
Ms Lapointe: Yes, they are.
Senator Spivak: We have not heard exact information. I understand that 25 per cent of the farms in the United States are using rBST; is that correct? Do you have any further information as to how they are doing, other than the vivid illustration that you gave us?
Ms Hutchings: I do not have information on the entire United States, but many American farmers come up to my area. We live in a big tourist area.
One farmer was telling us recently that he uses Posilac, but sparingly. For instance, if he has a cow that has a calf and she is not a good milker, he gives her a shot of Posilac, milks her for all she is worth and then ships her off for meat. As far as his basic herd, he will not kill them. Any stress on a cow will cause mastitis.
Senator Spivak: We have heard from the Dairy Council and the Canadian Dairy Farmers. Is there any other group within the farm community that is actually calling for rBST?
Mr. Dowling: There are groups in Ontario, Quebec and British Columbia that are calling for a ban.
Senator Whelan: Are those groups calling for a ban or for the use of rBST?
Senator Spivak: I am interested in groups that are asking for rBST to be brought in.
Mr. Dowling: Farmers, consumers and processors do not want it. When we say that, the question that comes back is who does want it.
Ms Lapointe: We do not know.
Senator Spivak: I have made the statement that farmers do not want it. I want to be absolutely sure that I am telling the truth.
Mr. Lloyd: My father was a farm appraiser for the Veterans Land Act. He asked the same question as you, "Are there any farmers that want this?" I said, "Dad, you know them all in your area, go out to the concessions, go down to the feed store and ask around to see if you can find any."
The next time I talked to him, he said, "You are absolutely right. I could not find any." There was not one.
Senator Spivak: The question has been raised by someone here that should the supply management system change would you be inclined to change your opinions. I know the answer, but I should like you to put it on the record. Someone did say that if we need to be competitive, we can produce more milk.
Mr. Dowling: Even if the supply management system does change, I would not anticipate that we would even want to change the system for the pooling of milk. That is an efficient system. It helps us to be more competitive. Even on an international market, it would make no sense to damage that in any way. Consumers will then not have the choice that was being spoken about this morning. If they did have the choice, who would be paying for that choice? It would be the people who had the concerns. That is usually how the scenario plays out. They would end up having to pay more for their milk and their children may not get enough milk.
Senator Spivak: I asked about the meat. The whole question of the antibiotic residue we were told not to worry about. However, a few years ago there was some problem with beef. They put hormones in the beef in the United States and it went to Italy and they have had unusual symptoms come about in babies in Italy. That is one of the reasons that the Europeans, even though the WTO ruled against them, were so strongly against importing hormones in beef because they had had this experience. Do you know about that experience in Italy?
I should like to know your views on the increased use of antibiotics and the residues of that in milk and meat and whether that can be solved by the fact that farmers must have a certain standard or else their milk is tossed out. What do you think about that?
Mr. Dowling: It is absolutely true that farmers must maintain a certain standard. However, the more exposure that livestock have to antibiotics or any other drugs, the increased risk there is of something getting into the food chain. There are many precautions taken to avoid that as well.
Ms Lapointe: I understand from speaking with people in the beef industry that the biggest loss for the beef industry are the injection sites on an animal. They must cut big pieces out of the animal because an injection site is spoiled meat. There is a loss there, too, that we are not looking at.
We ask is the economic problem here. It is a negative problem if we are to have a loss of milk tanks all over the place. I heard a representative from Monsanto at the hearing say to the media that, "We believe that consumers should have a choice. We will champion that. Well, yes in Canada there is a problem about pooling, but we will help them manage it."
Now they will help us manage the dairy industry in Canada. Maybe that is what their long-term goal is, I do not know.
Senator Spivak: There will not be choice because you cannot label it in Canada, as we have heard.
Senator Whelan: I will not ask many questions, which may surprise you all. I know these people and I congratulate them. With the resources that they have, they do not have money to bring a farmers' union representative from Australia.
Canada built one of the healthiest dairy systems in the world. As you said before, you hope that you would not lose that.
Some members of the committee are under the impression that we pay more for dairy products in Canada than Americans do in the United States. That is not true. The dairy products in Canada are cheaper than in the United States and are of a higher quality, too.
With respect to supply management, one of the ways to get rid of it started in the Uruguay Round. No farm organization, political party or organization asked it to be taken out of GATT. Supply management was organized within the rules of GATT. Big business and governments, not Canadian farm organizations, asked that it be changed to fit into the World Trade Organization.
Only one country can supply us with dairy products and guarantee that supply, and that would be the United States of America. If we were getting our supply of butter from them this year, we would be paying over $3 U.S. a pound because there is a shortage. Many farmers, even with this great usage of rBST, did not get the production they wanted because the price for their commodities was too low. Senator Spivak asked the question that I wanted to ask, namely, if you knew of any farmers using it.
I spoke to Ian Cummings this week. He writes for the Ontario Farmer. He has evidence that farmers were buying rBST at the border in Vermont. He even has pictures of them and names. He provided those to his editor. Someone is not just buying it to bring it into Canada to put on a shelf. Someone must be using it someplace.
Mr. Lloyd: I would like to put this Ian Cummings' story to rest. I also have in my files early articles in the Ontario Farmer before he was a stringer. He is a pro-BST person. Sorry, there is one.
Several years ago, Ian Cummings developed the argument that if it was smuggled into Canada, it was here anyway, and so it might as well be approved. He has gotten away with this for years to the point where this Senate committee and newspapers are talking about all this smuggled BST into Canada.
I do not believe it. I am in agreement with the Dairy Farmers of Canada when they say, "If you know of someone, tell us." I once phoned all the way through the RCMP and Customs channels. I have all the phone numbers you could want. If you know of a criminal in Canada using rBST, report them. We do not licence bank robberies just because there are one or two robberies. Let us stop talking about Ian Cummings.
Senator Whelan: You have not taken Ian Cummings to court. You have done nothing to him. If you think he is false, swear an oath just like these brave scientists who came forward with something they felt strongly about.
Someone suggested that one of these doctors was perhaps not telling the truth. We have to go through all this and hash it out again, but if you have evidence that Ian Cummings is incorrect, take him to court. Fine that newspaper rather than getting into bed with him.
Ms Lapointe: He is a neighbour of mine. He is not worth the time and effort.
Senator Whelan: Many people read about him, though. That is why I am challenging you.
The Chairman: Honourable senators, I wish to thank the representatives of the National Farmers Union for appearing here today and for the information they have provided to the committee.
I regret to inform the committee that due to the prolonged length of today's hearings, Maude Barlow of the Council of Canadians had to leave for an earlier appointment. However, she left with us her presentation, which we will append to today's hearings.
The committee adjourned.