Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 20 - Evidence - Morning sitting
OTTAWA, Thursday, October 22, 1998
The Standing Senate Committee on Agriculture and Forestry met this day at 9:05 a.m. to study the present state and future of agriculture in Canada (recombinant bovine growth hormone, rBST, and its effect on the human and animal health safety aspects).
Senator Leonard J. Gustafson (Chairman) in the Chair.
[English]
The Chairman: Honourable senators, I wish to call the Standing Senate Committee on Agriculture and Forestry to order. We have a long list of items to handle this morning.
First, I wish to lay out some of the rules. We will have short statements and then go to questions. It will be 10 minutes on the first round for each senator and five minutes thereafter.
I wish to make a short qualifying statement this morning. This is the second meeting of the Standing Senate Committee on Agriculture and Forestry on the subject of the use of rBST to stimulate milk products in dairy cattle and its implications for human and animal safety.
In June, the committee heard testimony from representatives of Monsanto, the company that processes and markets rBST, and from senior officials of Health Canada. Since then, the committee has received almost 200 letters and e-mails from the public expressing their concern and asking the committee to study the matter further.
Today, we have a long hearing ahead of us. We will hear from Health Canada scientists who have reviewed the methodology used in the department to evaluate rBST to date.
Following the scientists, we have representatives of the Dairy Farmers of Canada and the National Dairy Council, the producers and processors of the dairy products of Canada.
Before the scientists appear, some of them have asked that their union representative, Mr. Blair Stannard, Vice-President of the Professional Institute of the Public Service of Canada, be allowed to make a statement on their behalf.
Mr. Stannard, proceed, please.
Mr. Blair Stannard, Vice-President, Professional Institute of the Public Service of Canada: Mr. Chairman, and honourable senators, it is not unusual in the history of the Professional Institute of the Public Service of Canada for its members, the 30,000 professionals who work for the federal government, to appear before a Senate or House of Commons committee. We have been doing that for almost 80 years. The difference today, I suppose, is in having a union representative here to make an introductory statement. That is because of some concerns that arose about having public servants testify before a parliamentary committee without being totally assured as to whether or not there could be some recriminations.
Thanks to the intervention of this committee and the clerk of the committee, Mr. Blair Armitage, we have received assurances from the minister's and deputy minister's offices that no such recriminations will take place.
The professional institute is certainly glad to see that this matter has been clarified because, to us, it would have impeded the functioning of parliamentary committees in the future had such guarantees not been made. It could have happened at any time. You may not be aware, but in the past there have been legal precedents for the firing of public servants for refusing to appear before a committee. There also have been precedents for their firing when they did appear and testify. It was a catch-22 situation. This clarification from Minister Rock and from the deputy minister certainly alleviates many of our concerns.
To clarify, we represent all of the scientists here today. They are members of our union. We particularly wanted to make this statement on behalf of those who had received those warnings from the department about speaking "in public."
Four of the people who will be here today were members of the team that reported on rBST. Dr. Shiv Chopra has been with Health Canada for 30 years, and for 11 years has been a member of the Human Safety Division in the Bureau of Veterinary Drugs. Dr. Gerard Lambert has been with Health Canada for 25 years, all of it with the Bureau of Veterinary Drugs, Food Directorate. Dr. Mueller is from the Bureau of Pharmaceutical Assessment, Therapeutic Products Directorate, and has 17 years experience in this area. Mr. Mark Feeley is from the Toxicology Evaluation Section of the Bureau of Chemical Safety. Also there is Dr. Margaret Haydon, who was not a member of this particular review team, but has been in the Bureau of Veterinary Drugs for the last 15 years. Her role in the team was to produce certain critical information from her reviews of the safety and efficacy of rBST. She was a support to the review team.
Initially, Dr. Chopra was assigned the task of reviewing rBST by Dr. Paterson, the Director General of the Food Directorate. Dr. Lambert was co-opted into the process to assist him.
In mid-review, other people were added to the team by Dr. Paterson -- Dr. Mueller, Mr. Feeley, and Dr. Ian Alexander as the overall coordinator.
The report that you originally received, I believe, was not the entire report but the expunged one. The clerk informed me yesterday that you have now received the complete report. That is one concern of ours that has been lifted.
With that, in closing, I would like to draw your attention to a critical issue that was deleted from the officially released version of the report. This may be in the new report. It concerns the team's recommendations. It is the one that states that the rBST submission does not comply with the human safety requirements of section C08002 of the Food and Drugs Act and regulations. The primary reason for the recommendation was due to the results of a three-month rat toxicology study in which orally administered rBST was shown to be absorbed into the bloodstream, with implications for human health.
I understand that that information has now been made available to the committee. If that is correct, then that concern is alleviated.
I would now like to turn it over to the scientists to answer the senators' questions and assist them in their work.
The Chairman: Thank you, Mr. Stannard.
I will ask the scientists to take their place as witnesses, please.
I wish to make a short statement before we begin.
Witnesses who appear before parliamentary committees are protected by the privileges of Parliament. I understand that the witnesses from Health Canada wish to swear an oath. This is a proper procedure for parliamentary committees, although infrequently used.
I wish to stress that such an oath does not give you any protection in addition to that which I have already described and which carries with it legal implications.
I am correct in assuming that some of you wish to take an oath, is that right?
(Mr. Shiv Chopra: sworn)
(Mr. Gerard Lambert: sworn)
(Ms Margaret Haydon: sworn)
The Chairman: I understand that there are witnesses who would like to give a short statement before we begin questions.
Would you begin, please.
Ms Thea Mueller, Health Canada: I am presenting this statement on behalf of Mark Feeley and myself. This statement has been distributed to the committee members.
Based on our 21 years of collective experience in evaluating human drugs and food contaminants, and comprising one-half of the gap analysis team, we would like to offer the following points for consideration by the Senate committee during its deliberations on the issues surrounding the use of recombinant BST to increase milk production in Canadian dairy cattle.
First, the scientific issues dealing with the human safety, the animal safety and efficacy, have become intertwined with the internal conflict that the rBST submissions have generated within the Bureau of Veterinary Drugs. The scientific issues are quite distinct from the internal BVD conflicts. Each is equally important but each should be examined in its own right.
In our opinion, the tone, and some of the content, of the first report dated April 21, 1998, placed undue emphasis on BVD's internal conflict and tended to obscure and even override some of the scientific issues that the internal review team was called upon to examine.
In light of the above, why did we sign the first report?
Since the internal review team was beyond its deadline, we did not wish to stall the proceedings any further. However, this was on the assumption that the report could be modified, depending upon the comments received after its first circulation to interested parties, regardless of whether it was designated as a draft or not. This is an integral part of the consultative process that is customary practice in health protection branch directorates. Indeed, a more concise version of the original report had been drafted. It did not gain acceptance by the BVD members of the internal review team.
Even after some valuable comments had been received, the BVD members refused to make any revisions to the initial report except to add these comments as an appendix. It was for these reasons that the second report, dated June 10, 1998, was prepared. It focuses on the scientific issues that must be resolved before any definitive conclusions can be made regarding the human safety of the milk obtained from cows treated with rBST.
Second, it was not the mandate of the internal review team to make any recommendation regarding the human safety of the product per se, but only whether or not the data upon which BVD's conclusions were based were adequate.
The mandate of the internal review team was limited to the identification of any deficiencies or gaps in the information that was considered necessary to draw valid conclusions regarding the potential adverse health effects of the residues in milk from the rBST-treated cows. The question the team had to answer was whether the manufacturer submitted sufficient data to provide convincing evidence that the milk from cows treated with rBST was safe for human consumption. If additional data was deemed necessary, then the internal review team was to provide an identification of what additional data was necessary, including the type of studies that should be conducted. Hence the term "gaps analysis."
Third, the documents examined by the internal review team consisted almost entirely of summaries of data prepared by the BVD evaluators over the years or by other regulatory bodies or of review articles from the scientific literature. Consequently, our analysis was based on the assumption that the experimental designs met acceptable scientific standards of the day and were analyzed by appropriate statistical methods. Only studies that are properly designed and analyzed can provide sufficiently reliable data to generate valid conclusions. Ideally, the best approach to identifying misinterpretations, biases or inadequacy is to examine the original data set from which these summaries were prepared.
Fourth, in the previous paragraph, reference is made to scientific standards of the day. It is important to note that our knowledge of the physiological functions and pharmacokinetics of proteins such as somatotropin or insulin-like growth factors, abbreviated to IGF, has increased tremendously since the rBST submissions were first filed with BVD almost a decade ago. Thus, the gap analysis report should not be misconstrued as questioning the competency of the evaluators receiving the submissions at the time of filing. Certain assumptions considered as fact 10 years ago may no longer hold true today.
Fifth, the internal review team was charged to examine only the human safety aspect. However, there are other factors that impinge upon the decision-making process. For example, the division in BVD that deals with the safety and efficacy in the target animal species has refused market authorization on several occasions because the adverse side-effects of rBST treatment outweigh the benefits -- namely, the degree to which milk production is increased.
Sixth, when a submission is at stake, the decision to approve or not approve the product must be taken at some point. It is not uncommon for regulatory agencies to have to make such decisions in the face of some uncertainty. In such instances, the weight of the evidence, assumptions erring on the side of safety, that is, worst-case scenarios, and uncertainty factors to compensate for the extrapolation of animal results to humans, are applied. Uncertainty factors reflect knowledge gaps in this risk-assessment process and decrease as the confidence in the data increases.
For agents that are not carcinogens, an uncertainty factor of 100 is generally employed, when a full toxicological assessment is available, to establish an adequate margin of safety when extrapolating the no-observed-adverse-effect levels derived from animal studies to humans. For carcinogens that act through genetic mutation, it is assumed that there is no level of safe exposure. In cases where exposure cannot be avoided, scientists use mathematical models to calculate exposure corresponding to a very low level of cancer risk, such as one in a million.
Now, with respect to the IGF1, although it has been implicated as a potential tumour growth promoter, it is unique in that it is also a necessary growth factor for normal pre- and post-natal development, and it is also produced in fairly large amounts by various tissues in the body. For example, according to the manufacturer's data, the concentration of IGF1 in human milk early in lactation can exceed that found in the milk of rBST-treated cows. Indeed, IGF1, the production of which is regulated by the growth hormone, is required for normal growth and maintenance of health in both humans and animals. Note that unlike the situation with the growth hormone itself, which is species-specific, bovine IGF1 would be expected to exert the same physiological effects in humans as it does in cows.
In summary, the main toxicological concerns that have been raised with respect to the use of rBST are: (a) would rBST residues be absorbed intact from the gastrointestinal tract in sufficient quantities to produce a toxic and/or immunologic response; and (b) would IGF1 residues in milk or milk products survive the gastrointestinal tract environment to produce localized effects, or be absorbed intact and remain bioactive in sufficient quantities to produce systemic effects?
The evidence available today should be judged by individuals who have the experience and expertise to understand its complexity and the possible long-term consequences in humans.
In our opinion, an accurate exposure assessment would better characterize the risk. As indicated in the June 10, 1998 report, the residues of IGF1 in milk of the rBST-treated cows pose more of a toxicological concern than that of the growth hormone itself.
To determine exposure, the following should be investigated: Are the assay methods used to measure IGF1 valid and sufficiently reproducible so that the results of the different studies can be directly compared? What are the levels of IGF1 in the milk of cows treated with rBST over a prolonged period of time, not just over one or two lactations? And there, the use of dilution factor should not be permitted. To what extent do current milk processing practices in Canada affect the biological activity of IGF1? To what extent is the IGF1 in the milk of rBST-treated cows absorbed into the systemic circulation when ingested, and what portion remains biologically active? How do the levels of biologically active IGF1 that are retained in the gastrointestinal tract -- and presumably in the plasma -- when milk is consumed from cows that have been chronically treated with rBST compare with the levels produced endogenously?
With answers to the above questions, a comprehensive risk-benefit assessment should be undertaken encompassing the following three factors: human safety, target animal safety, and target animal efficacy.
I thank the committee for granting me the opportunity to take part in what I consider to be a true democratic exercise -- to assure that the health of Canadians is protected to the best extent possible.
The Chairman: Thank you, Dr. Mueller. This presentation was prepared by Dr. Mueller and Mr. Feeley.
We will now hear from Dr. Chopra.
Mr. Shiv Chopra, B.V.Sc., M.Sc., Ph.D., Health Canada: Mr. Chairman, I have decided not to make any statement to help in the expeditious proceedings. I would refrain now and we can proceed straight to the questions.
The Chairman: Are there any other witnesses who wish to make a statement?
Senator Whelan, our Deputy Chairman, will begin the questioning.
Senator Whelan: Colleagues and witnesses, ladies and gentlemen, we are studying this issue of rBST because of my long-time concern about its use. I suggested it be studied by this committee, and the committee chairman and my colleagues agreed. Perhaps I have a biased opinion of this product, but it is because we -- the farmers of Canada, the provinces and the federal system -- built one of the healthiest, best-producing dairy herds in the world. We do not have a shortage of milk. I have strong feelings about using anything artificial to make a cow produce more milk.
I notice lengthy experience amongst you. I have added it up roughly here to be over 70 years of experience as scientists doing this kind of work. You are highly qualified. You will have to excuse some of my questions because these are the kinds of questions you would hear from an ordinary citizen or a farmer or a consumer.
What has been your involvement over the years regarding the rBST review? How long have you been involved in this review?
Mr. Chopra: Mr. Chairman, I have been in the department for 30 years and in the Bureau of Veterinary Drugs for the last 11 years. Before that, I was in the human drug area. As far the rBST review at BVD is concerned, I have been involved virtually from the beginning up until now.
As you will see from the report itself, even though I continue to play a central role, in the intervening years I was kept from taking any direct part in the actual review. So, incidentally, were all of my colleagues in the human safety division. There are five of us.
The reason I say I was involved right from the beginning is that there is not just one rBST. At that time, several companies wanted to produce and market rBST for Canadian cows.
One of the companies, Elanco, had an investigation and a new-drug submission in 1988. They submitted it to our department. I happened to be acting chief of the Human Safety Division at the time. Based on what I saw, a review was done.
According to that review, some serious questions needed to be asked. A letter was issued to the company. We call it an "additional data letter" asking the company to reply before they could have permission to test it in Canadian cows. That letter was sent but it was never pursued in any substantive manner. It has been sitting there. After that, the department actually approved the investigation of that new drug for Elanco on explicit recognition from the regular Human Safety Division chief, as well as the upper management, saying that there were no human safety concerns.
I come now to the current review report. I was central in inducing the department to actually appoint someone to look into the files and report back to the director general. This happened in October of 1997. The minutes to that effect are on file.
My colleague Dr. Mueller talks about the conflict. Conflict is not peripheral to this. Rather, rBST and other drugs have been central to the conflict. The conflict was not that we were unhappy with our own personal jobs, our promotions or anything like that. The conflict was that our concern at the BVD, particularly in the Human Safety Division, has been that we have been pressured and coerced to pass drugs of questionable safety, including rBST.
That was our concern. Since then we have filed grievances. I personally was very concerned. I stuck my neck out and I wrote to the previous minister of health and the current minister of health as well as all the way to the deputy minister, complaining about these very serious problems of secrecy, conspiracy, and things of that nature and saying that something needs to be done. I specifically wrote to Minister Dingwall. I urged him to intervene to safeguard the public interest. I never received a reply from the former minister or indeed from the current minister except after my grievance was addressed.
We went to our union, the Professional Institute of Public Service of Canada. On our behalf, the president of PIPS wrote an open letter to the Prime Minister and the word rBST was actually mentioned in there.
Our grievances were rejected. They were not actually heard. We gave the department piles of data, not just on this drug but on a whole volume of other drugs, stating that there is a very serious problem and that something needs to be done. The department did not examine or investigate. All we were looking for at that time was to appoint somebody external to investigate the problem between management and the people actually doing the reviews. The department chose not to do so. In fact, they rejected our grievance.
Again, rBST was one of the issues in those grievances. It was addressed by the associate deputy minister, Mr. Nymark, who wrote that rBST, using it as an example, has been sitting in the department for approximately nine years and that this matter needs to be addressed. He also wrote that he would now appoint an external advisory committee.
At the same time, he wrote that all these things were due to some interpersonal problems at BVD or some scientific difference of opinion. The ADM has been making statements in the media that this is not uncommon among scientists. We agree, but the point is that if there is a disagreement among scientists, then management has to ensure that all those opinions are brought together and that management hears everyone.
We have learned that, at the previous hearing before you, the senior managers, Dr. Losos and Dr. Paterson, appeared before you. Dr. Losos has never met with us. On the day we presented this very report to Dr. Paterson and the ad hoc committee on rBST in the department of which Dr. Paterson is the chairman, Dr. Losos was sitting next door in his office. He did not attend the meeting.
When we finished our presentation, we came out and we actually met Dr. Losos for the first time, although I have been in the department, as I said, for 30 years. None of us had met.
Dr. Losos, neither at that meeting nor afterwards, chose to meet with us. Some of the questions that have come up are very scientific -- and they were raised by Dr. Losos himself -- such as the immunology and teratology, which is birth defects. Dr. Losos has received those answers in this report. He has never, ever sat down to discuss them with us.
That is what I would like to present for your consideration as we proceed.
Senator Whelan: Thank you, Dr. Chopra. I guess I was a different kind of minister. I am not saying I was completely able but I tried to keep a listening post on what was going on. I am amazed at some of the things that you have said here. We will have to do some double-checking. We received a letter as late as yesterday from the minister. In my opinion, it conflicts with some of your evidence.
I gathered from Dr. Mueller and from you that you did not get much information when you started the review. Is that right?
Mr. Chopra: No, sir. In fact, in October of last year, a presentation was made by Dr. Yong, the chief of human safety division.
This was in preparation for taking this material now to the Codex Alimentarius, which had asked -- which had cancelled the previous meeting in June of that year and they had now asked to make further presentations.
And because we had been complaining that this information had been kept secret from us, none of us was -- had access to files on rBST. And at that meeting, after the presentation, I raised some questions about the possible -- I was only talking in theoretical terms because I only remembered from 1988 what I had written, what could be the concerns, such as the immunology and so forth. These are the detectors of possible problems.
And I raised those questions with Dr. Yong that: You say that there is no human safety concern. What is your basis for that conclusion? Could rBST be absorbed?
And he said it's a protein and it will be digested away.
I said: That's an assumption. Have there been any tests to show so?
He said -- again, he somehow, that's his mannerism -- ridiculed me there. But I said: Look, even proteins when they are digested, even the smaller molecules, digested parts, can produce antibodies. Has that been done or tested?
Again he said: No, it's not necessary.
In fact, there's a report by him saying if there was something -- and then it wasn't necessary. It was not in any of his previous reviews.
I approached Dr. Paterson, who was chairing this meeting, and I said: Dr. Paterson, I have personally no objection if Dr. Yong or you or any other manager says that you think there is no human safety problem. But if you are saying that on behalf of the department, then they are assuming us as well, and I would object to that, if you do that. And if it goes that way, we will publicly oppose you on that.
In that respect, I requested Dr. Paterson: Why do you want to take this matter in this way? Why won't you appoint one or two of us and look into the file and report back to you?
And he agreed and he said: Any volunteers?
And another month passed. They tried to find a volunteer and they approached one of our colleagues, Dr. Basudde. And Dr. Basudde said it was -- he was not willing to do it alone.
The whole -- he wrote to Dr. Paterson that it should be the entire human safety division. At least we'd get a full spectrum of opinion and objectivity. That was his -- and he said the chief himself should also be included.
Dr. Paterson brought this back to the subsequent meeting. We are all now at the end of October -- I think in November. And Dr. Paterson addressed me; he said: That was your proposal. What do I do now?
I said: Sir, you're the director general. You do -- you order us and we have to do it. And it's up to you. Are you asking me to find you someone to do it or are you asking me to do it? If you are looking for a volunteer, you can't find one, I offer to do it.
And I said -- and he said, all right. And then I gave him some of my conditions, that I will not be reviewing the --
Senator Whelan: What year was that?
Mr. Chopra: This is last year, 1997 in November.
And I said to Dr. Paterson: I offer to do it but when I do so, the entire human safety division staff will be involved. And I will not be doing any scientific assessment of it. I am only going to look into the file and report to you very quickly what should have been done, what was done, and what still needs to be done. And that was agreed to.
Within two days, I met with the human safety division. The division, by consensus, decided that Dr. Lambert and myself will become the coordinators but everybody will be involved. And we wrote to Dr. Paterson very quickly, within two days, that this is our decision and we need to get all the files and data.
And that as it was beginning to -- as we were beginning to do our work, suddenly Dr. Paterson called us back, wrote to us that he has now expanded that, what he called gaps analysis team, to include two more people, those being my colleagues on my left and right.
We met with him at that time and he now said he wants a scientific gaps analysis. We can understand that the mandate he gave to outsider people, who were outside of the bureau, was to look at the scientific part. And when we received what we were supposed to review, we found there were only summaries from the FDA, from the European commission, from JECFA, and also only the reviews within the human safety division done by the chief, but not the actual data.
And we -- Dr. Lambert and I -- wrote to Dr. Paterson: Number one, do you still want us to proceed? Because now Mr. Nymark, the associate deputy minister, says there is going to be an external committee looking into it. Do you still want us to do it?
He wrote back: Yes, he still wants us to do it.
And then when he expanded the team, we wrote to Dr. Paterson that we are now in a grievance situation. Our complaint is before the Public Service Staff Relations Board. So, therefore, in order to avoid any conflict and any lack of objectivity on our part or any bias perceived by us, whatever, please excuse us. So we find it very awkward to participate in this matter now.
Dr. Paterson wrote back that, no, he still requires us to do it; he expects our cooperation and that he -- our grievance and complaint has nothing to do with it. And also he said that as he receives our report -- when he met with us, he said he wanted one report, a single report, not several independent reports. He wanted consensus. We said we agreed.
And as we proceeded, there were difficulties. The difficulties were, now he had appointed another coordinator who actually is the file manager of rBST since -- for the last three or four years, Dr. Ian Alexander.
His role was going to be as the file manager. Incidentally, this is the gentleman who guards all rBST files in the department. Nobody else is allowed to see the rBST files. This is unique to only this file. Every other file is accessible to us in the central registry.
So his role was going to be to coordinate this and report back to Dr. Paterson on a weekly basis, because he wanted an expeditious report, because he said our report will be sent to the two outside panels.
Senator Whelan: Is Dr. Paterson a scientist?
Mr. Chopra: Dr. Paterson is a scientist. He is not a veterinarian. He is a chemist. I personally do not know what his specific background -- I think it is chemistry. He comes from agriculture. He was not in the department. He has been in the department since, I believe, '97 or '96.
The Chairman: Senator Whelan, your time for questions has been exceeded by about five minutes. I do understand that Dr. Chopra has made a statement as well.
Senator Whelan: I just want to say this, Mr. Chairman.
You have enlightened us. If I could say one little thing, I am appalled at some of the things that you have said about evidence and secrecy, et cetera. To me, rBST is one of the big problems in the first instance. When you start studying this, you can go back to, what, 1930 and find out when they were playing around with this same product, maybe used with a different name, et cetera.
You explained how the records were kept by Dr. Paterson and that nobody else can see them. Were they in a vault?
Mr. Chopra: Yes, they are kept -- they are locked up. They are kept in the personal custody of Dr. Ian Alexander, who is called the file manager of rBST. No one else is supposed to look into it. In fact, in our proceedings, we had great difficulty in obtaining the necessary data.
Senator Whelan: Is Dr. Alexander a scientist?
Mr. Chopra: He is a scientist. He is a veterinarian. He is in the bureau.
If you indulge me for a second, my wife, who used to work in the department, bought me this book for $1 last week from a book sale. In here, you are quoted.
Senator Whelan: Me?
Mr. Chopra: This is when you were the minister of agriculture, so this book is dated. The title is The Public Right to Know. It is by a professor at the University of Toronto. What he is saying about the quote from you is in a different context, when people wanted a lot of money. You are quoted to say that Canadians, whether they are academics, welfare workers, farmers, whoever, are free enterprisers when times are good and socialists when times are bad.
Senator, times now are bad, but if I may extend that: What you said, it is not only money, but also the public interest, and so it is a social conscience as well as economic, social well-being of the country.
The conclusion of this book is that there must be disclosure, exposure, and public scrutiny. I think the disclosure has occurred. Exposure is occurring today. Public scrutiny is in your hands.
The Chairman: Thank you, Senator Whelan. You will have a second chance.
Senator Spivak: Mr. Chairman, I would like to get to some of the issues in the science here, if I may.
Both of the gaps reports were signed by all of the scientists, and they are very similar, from what I can gather. There is a difference, but they identify both procedural and scientific gaps in the rBST evaluation process. That is the first thing. There were indeed procedural and scientific gaps.
If I can just get this into the record, Mr. Chairman: In the June gaps analysis report, you say in the summary that the usually required long-term toxicology studies to ascertain human safety were not conducted. Hence, such possibilities and potential as sterility, infertility, birth defects, cancer, and immunological derangements were not addressed, and virtually no attention appears to be directed towards the critically anticipated increase in rBST-related infective mastitis in dairy cows and also the concomitantly expected increase in antibiotic therapy and antibiotic resistance in the farm-borne pathogens of humans.
I would like to ask Dr. Haydon about that.
Before that, there is also in the June report, in the scientific gap, which really kind of startled me -- it did not startle me, but I think it is key here, because we are dealing with a sub-population. It says potential effects of IGF-1, in particular, on the neonate, the sub-population -- that is children, right? -- the sub-population at greatest risk was never explored. Later on, it says -- and I want you to comment on that -- that the JECFA people did not look into that particular aspect of it -- that is, the effect of IGF-1 on children.
The study that seems to be at the key of this is that 90-day rat study. Apparently, the FDA in the United States only saw a summary of that study, which was incorrect as it turns out, and on that basis they made their decision that rBST was great, and it has been in the United States since 1993. Here in Canada, however, you actually had the raw data.
I believe it is Dr. Lambert and yourself, Dr. Chopra. Here are my questions: I want to know what is the significance of that study. What did it show for our purposes, and what is the particular significance on children? What is your feeling about rBST and the -- because children drink the most milk. And third, I would like to ask Dr. Haydon to comment on the increased incidence of mastitis and antibiotics.
I am doing this all at once, Mr. Chairman, in the interests of time, so that I do not go beyond my allotted time and hopefully will have a second round.
Would you please comment on the study and what it means, and then we will go on from there.
Mr. Chopra: Toxicology assessment has evolved over the last 100 years in the food and drug business in different ways. At the beginning, in 1906, all we had was that whatever foods, drugs, whatever substances assumed for humans should not be adulterated, so therefore it used to be called the Adulteration Act. In 1938, the first actual Food and Drugs Act came into being. U.S. and Canada go generally together on most things, and they did on this as well.
It was because a serious consequence had occurred, a sulphonamide drug was mixed with something else, and some 38 people died. Therefore, that is the first time toxicology came into being, that drugs to be given to people must be tested thoroughly in laboratory animals. Not only should they be chemically pure, but they must be tested biologically to see they do not cause any adverse effects in the laboratory animals.
What you do is, you take at least two species, one of which can be rodents and the other one must be a non-rodent, and you give very large doses of the substance to see where you literally might kill the animal, and then you work your way backwards to see where are the toxicological effects. That was 1938.
We proceeded happily until 1962, and then thalidomide came. Suddenly people said, "We have to now study not only the adult animals, the toxicology in adult animals, but also in the unborn offspring." So that science is called teratology. In fact, it was extended to go a step further, that we should study even the reproductive system, the whole process, if there is any effects on the sperm count of the animals and the ovum transformation, et cetera, et cetera. All those things must be studied.
Thirdly, long-term toxicology studies should be done, that there is absolutely no suggestion of cancer. In fact, in the United States, there is a specific clause called the Delaney clause. If there is any chance of mention of cancer, then that drug, regardless of whether it is safe or not proven, is not to be used. That is the U.S. We do not have that clause here, but we do expect long-term toxicological studies.
When we come to substances like the rBST, we are walking into an unknown territory. We are not now treating sick animals or people. We are going for economic benefit. There is nothing wrong with that. That is the way science works, and we must advance.
However, any time there has been a problem in the past, it has always been discovered through epidemiological evidence. First, the problem occurs, and then you go back and find out what happened, like thalidomide, like the sulphonamide story of 1938.
When you use something like BST in cows for economic purposes, there is no way to know now what it will do. Therefore, there are issues like immunology or IGF, things we do not know, any indicators that you might be looking at -- what it might be doing at the molecular level -- and there are issues of antibiotic resistance, which have a direct effect coming out of overproduction of milk, causing mastitis; overuse of antibiotics, causing antibiotic resistance. Fifty per cent of the antibiotics are used -- all antibiotics are used in animals and farm animals, so the spillover effect of that is directly on the humans, because antibiotic resistance is now killing people because you do not have antibiotics to cure people. You go to hospital to get your appendix out, and you pick up an infection and you die because it cannot be treated any more. Those are the kind of concerns.
Therefore, what we scientists have to do, in weighing the risks and benefits, is to somehow gaze into the future, into the unknown territory, so we are changing the existing risk/benefit method by which we have been doing up to now, that you first know the risk and, once that risk is eliminated, then you can proceed.
Here we are taking a risk that we do not know. Therefore, that is the kind of thing that has happened with blood and breast implants and other situations.
If you are working on an epidemiological situation into the future, the question then comes, if it is done for profit, then there is also going to be a liability if things go wrong. When things go wrong, who will pay for it? Are we going to pay? Is the public going to pay? Is the government going to pay, or is the company making a profit going to pay for it? And other risks, too. In this particular case, there are economic risks to the cows and the farmers and our dairy industry. Although that is not in our jurisdiction and mandate, that is somewhere else.
Nevertheless, these are new factors that are coming into play. And our ADM has said, "Well, if it is money and you cannot prove risk, then economics shall prevail and science will take a back seat." I cannot agree with that kind of attitude that is developing.
Senator Spivak: Dr. Chopra, if I may, I would like to ask Dr. Lambert and Dr. Haydon to comment on the raw data. By the way, when you answer, could you tell me if it is just summaries that are being sent to those external committees, the two committees that are studying, or are they getting all your reports and the raw data as well, those committees that were set up, the veterinary one and the royal college of surgeons.
Mr. Lambert: To answer that question, we do not know if our report is sent to the two external committees.
Senator Spivak: Okay. Could you answer about what the raw data showed you?
Mr. Lambert: The raw data showed us that there was some absorption of the rBST by oral route of administration and it gave some immunology problems. It produced some antibodies in the rats and it is by oral route of administration. And in some of the rats, it was up to 30 per cent of the -- that were shown that effect.
It showed that there is some absorption of the rBST and to some extent, and it was the only parameter that was positive in that study for the effect of rBST after oral route of administration.
It was some of the -- but that information was not part of the previous reports.
Senator Spivak: It was not in the summary. The Monsanto summary was different, right?
Mr. Lambert: Yes, it was submitted by Monsanto. It was part of the submission from Monsanto, but it was at the end of the submission, but it was not in the summary of that particular study. And we have to go through all the pages to find out that study.
Senator Spivak: I think I understand. Dr. Haydon, could we hear about the mastitis and the antibiotics then?
Ms Margaret Haydon, D.V.M., Health Canada: Just a brief background. I was in private practice for 10 years as a large animal veterinary practitioner before I joined the Bureau of Veterinary Drugs about 15 years ago.
My first contact with the reviews of bovine somatotropin was in about 1994. I have looked at submissions from three different companies, from about 1984 to about mid-1994, when I was taken off the review. And I had documents stolen at that time. So my information is sort of dated but, yes, there were problems with mastitis at that time and the company's label even indicates that more recently now today.
Senator Spivak: What effect does that have for human health in terms of the increased antibiotic use?
Ms Haydon: When there is an increase in the incidence of mastitis, the farmers are naturally going to increase the amount of medication that is given to these cows in order to try to treat this infectious disease. Of course, my concern is the potential for the increased use of antibiotics promoting increased resistance in the on-farm bacteria. These can have potential human safety effects in the sense that the organisms on the farm may acquire that resistance, as well as the organisms that humans have. There is a transmission of resistance between bacteria.
Senator Stratton: I have two lines of questioning. The first goes back to the fact that three of you swore an oath. My question to those of you who did, as well as the other two: Are you now satisfied that your personal professional life will be protected? In other words, do you believe that you no longer have any worries about actions being taken against you? That is a fundamental question.
Mr. Mark Feeley, B.Sc., M.Sc., Health Canada: I think I can comment on at least per se on my part. I was asked to join the committee by Dr. Paterson as an external adviser to the committee. I primarily work in the area of chemical safety for foods. So theoretically, we handle the human safety for all -- both indirect and direct food additives, food packaging materials, and any contaminants that may show up in the food supply, including breast milk.
For my basis, I am sort of a little foreign to the internal conflicts that have occurred in BVD. I could go on record as stating that the overall impression of the BVD review, prior to myself and the other three colleagues joining the internal review committee, if positioned as a something that has been added to food, I would substantially agree with their position that they have taken on rBST residues, in particular. There is limited risk associated with that compound or protein.
In prefacing the information that Dr. Lambert has presented, the doses required to produce an immunological response by the oral route were thousandsfold greater than what the potential maximum human exposure would be. There is a distinct dose response relationship. So the doses that they produce response through, on an average, a rough estimate would be 60,000 times greater than what a human would be exposed to.
A dose that showed no effect in the same study was 6,000 times greater than what humans are exposed to. What Dr. Mueller and I pointed out in the June 10 report is that there does seem to be concern regarding the amount of information that has been provided on the pre- and post-natal animals specifically for IGF-1.
As far as my professional career, I have been under no undue duress to appear here. I was fully prepared to accept the first invitation. It was just the acceptance of our directorate to have me participate.
The Chairman: The committee did receive a letter from the minister.
Senator Stratton: I was going to go into that.
I guess the question I have is that the minister has sent a letter to the committee stating that you are, as a group, to testify honestly and directly without fear of reprisal. Do you feel comfortable with that letter? Do you really feel comfortable with the grievance procedures? We know ministers come and go quite often. Would you like to respond?
Mr. Chopra: I think when we received the invitation the first time, first of all it was only to indicate the dates that we would be available, and we said we would. This information had only come from the parliamentary relations office in the department. No manager was informed or asked whether this was all right. When that date was confirmed, we received an e-mail from parliamentary relations, Lawanda Willar, saying that the arrangement has been made and you have been invited. Those of you who wish to go make a presentation should call Mr. Blair Armitage. There was no copy, nothing to any manager in the department. When I saw that, and having already received a reprimand to speak in public on any issue relating to my grievance or anything else -- of course with rBST, repeated references were made. There is only one person who can speak about rBST to the media, and that is Dr. Ian Alexander or Dr. Landry in French.
Having received that and the second letter from the director, Dr. Lachance, saying I could not even attend a public meeting on whatever matter at my own time, evening, weekend or whatever, this said, on the presumption that being a well-known member of Health Canada, anything I say could be used as the opinion of Health Canada. Therefore, I was forbidden to attend a particular meeting where I was supposed to speak on genetically engineered foods. All I was going to talk about there was how the regulations work and nothing about any specifics, nothing about a drug or the department. But the department presumed that that is what would happen, and so therefore I am not to attend.
Having that, number two, with me, and the third, a written order, or at least advice from the same Dr. Lachance, who had only been in the department since the first of April of this year, saying, in writing, to change and alter the report. He was concerned once the report is written and accepted and signed the way it was, then it is subject to access to information, and so therefore there could be problems. So now is the time to change it.
He said that at the meeting, and I asked if he would put that in writing, and he did. Not only that, he encouraged two of his chiefs to also write, and those comments are also in writing to us.
Under those circumstances, in receiving this kind of an indirect invitation from the Senate committee, I personally am fully familiar with the obligations and the authorities of the Senate, the highest rules-setting authority -- in spite of what we hear in the media from time to time about the Senate -- in the country. Therefore, I knew what my obligation was, but considering the situation, I said, "I am not in a position to attend this hearing." For that I apologize, but it caused some delay.
What happened as a result was that this letter from Mr. Rock appeared. It is true he says there is no question of any recrimination, but the next sentence also says that we can only speak from the report that was released at the time, the deleted report. With that, and then Mr. Dodge's letter, the deputy minister's letter, makes it even clearer that we would be in great jeopardy if we were going to go and appear and speak the way we have.
Under oath, we even received an interpretation from the Privy Council how we are supposed to speak. So if we are speaking under oath, the question that I had to myself -- and that is the question that is being asked -- if I have sworn an oath in the presence of God, then I am supposed to tell the truth, the whole truth and nothing but the truth. Then the second oath which is taken here, and that is from an expunged report, then my question to myself was, what truth am I going to tell -- the one I know or what the minister is telling me to tell? That was my conflict.
So I don't expect -- I do not know, although in the presence of the illustrious committee, it has been confirmed that there will be none -- it has been said that there is a guarantee that there will be no repercussions, but we do not know. That remains to be seen because I am still under a complete gag order, to the extent that I cannot even attend meetings. If I said something at a dinner meeting and somebody heard and reported to the department, I could be in trouble.
Senator Whelan: Or on an airplane.
The Chairman: May I interject just a minute. We only have until 11:30. We have two other witnesses from the dairy farmers and the processors to hear yet today. Perhaps we could keep that in mind.
Senator Stratton: I would like to see the letter. The committee would like to see any letters. Are you under gag not to submit those letters as well?
Mr. Chopra: Well, I do not know, sir, because according to the letter, I cannot speak in public. It says that there is another mechanism, which is a grievance before courts, and so on. So the Senate could be like a court. I am not quite sure. I have not brought the letters with me, but they can be supplied if you ask.
Senator Stratton: Finally, it does not appear to me that you have a lot of confidence in the process, obviously. One thing I would like to impress upon you, as this committee has done with respect to rBST when it saw a problem and is now having these hearings, if you do have a problem with respect to grievances or with respect to threats from management, this committee would be delighted to hear from you.
Senator Hays: There seem to be two or three things going on here at the same time. Let me ask a few questions to try and help me resolve what it is we are trying to get at here today.
First, I gather that rBST is not authorized for use in Canada at the present time. Perhaps you could confirm that and give me an answer as to why it is not.
I also hear a lot about the management of the department or branch of the department that you are in and how differences of opinion among scientists are resolved. You have some concerns about that, which I think I understand. To the extent I do not, I will review the record and perhaps understand them better. Of course, we will be hearing from people in the department or branch of the department that you are at who will also give us some views on that, which will be helpful.
On the final issue -- and I will make these three points -- that is the scientific problem here. It seems to be well described in the paragraph on page 5 of your presentation, which starts with the words "in summary." There are two substances here, two hormones, I guess, which are under review. One is BST or a recombinant form of BST, and IGF-1. Dr. Feeley commented helpfully, I think, on the BST or in terms of where we are at. It would take massive doses to raise concerns about that. I gather that, without getting into the issue of whether or not the right decision has been made here or a decision has been made here that we can all have confidence in, the bigger issue, or the one that I am less informed about, is the IGF-1, the insulin-like growth factor. I have a concern about its absorption through metabolic processes into the things that happen inside you when you consume it. Specifically, is this a really bad thing, this IGF-1? I gather it is a naturally occurring substance, and we have forms of IGF for different species. The issue here is the one for dairy, for cows, and the one that is bad for humans.
Is there any evidence of that? What are the grounds for concern? Does the consumption of IGF-1 cause cancer? Does it produce bad results, in the human context?
Mr. Feeley: The information regarding IGF-1 has been reviewed by Health Canada, FDA, and various external expert committees such as the Joint Expert Committee on Food Additives. Europe is basically working under the hypothesis that bovine or cow insulin growth factor 1, due to its amino acid composition similarity, would be expected to perform identically to human IGF-1. As far as I know, I am not aware of any scientific studies that have actually shown that bovine IGF-1 is equivalent, but working on the amino acid basis or the structure of the compounds, you would expect IGF-1 from cows to be active in humans.
The IGF-1 basically can be described as a multi-potent growth promoter of numerous organs, produced in the liver. There is some scientific evidence to suggest that it may have an influence on human prostate cancer and human breast cancer, being that it does promote the growth of cells.
The question that needs to be resolved is, that is IGF-1 demonstrated to be -- as with the bovine growth hormone -- simply a protein that is digested in the gastrointestinal tract or can it be absorbed intact and bioactive?
I think even though there are two reports before the committee, we are probably all in agreement that there should be some additional evidence to support the fact that IGF-1 does have the potential to possibly survive the GI tract environment and could potentially be absorbed. The position that has been reached by other expert committees who have agreed with that assumption is that that amount of IGF-1 would have a minimal contribution to the overall human quantity of IGF-1 -- and the last estimate has been approximately .1 per cent -- if 100 per cent of the IGF-1-supplied milk survives the GI tract and is absorbed intact and bioactive.
I guess one of the questions that we have raised is that that is fine for humans, but what exactly is the situation with humans that are breast feeding? As outlined in the report, these are some of the things that we would hope would be investigated.
Senator Hays: Before we leave Mr. Feeley, in terms of the breast cancer and prostate cancer, do we know that, or is that just something that we speculate is a potential problem?
Mr. Feeley: There is no firm evidence that IGF-1 either promotes or initiates either breast cancer or prostate cancer growth. There are scientific reviews or articles that have been published in the past years that, in adults, show -- these are in the studies occurring when the people have been diagnosed with the cancer -- increased levels of IGF-1 in their circulation. Is the increased IGF-1 produced by the neoplasia itself or the cancer, or is it causing the cancer growth. The mechanism of action behind IGF-1 is that it is described as a mitogen or something that stimulates cell growth. Theoretically, if someone did have a cancer developing and you had an increase in IGF-1 concentrations or more IGF-1 being produced, it would possibly stimulate the growth of the cancer, but I think what we are also getting at is that numerous organs in humans produce IGF-1.
Senator Hays: IGF-1 would be part of animal --
Mr. Feeley: That is correct.
Senator Hays: Meat and other things that might have it.
Mr. Feeley: IFG-1 concentration in meat products, I do not believe, at least the evidence that has been supplied, is shown to be elevated. Usually an animal, if it has been treated with the growth hormone, the first place you see an increase is in the blood.
In certain cases you will find, and that is one of the other things that I pointed out in the reports, that we don't believe that there is -- there has been -- I guess sufficient or firm evidence to actually show on an exposure basis. The contentions of the petitioners are that -- which has been presented to other expert committees -- the IGF-1 concentration in cows' milk that is increased, is to the extent that occurs naturally in human milk.
But being that that is part of an overall assessment review that was to be provided by the petitioner to FDA, I have not seen any information on that basis. But I think once again we are not debating the fact that IGF-1 could not be active in humans. The contention, or at least the position that has been reached by other agencies, is that the minute amount of IGF-1 that would potentially increase the exposure is minimal in terms of what the human body normally produces.
I guess one other point I should add is that on the expert committee by the Royal College of Physicians and Surgeons of Canada, there is a growth hormone expert specifically on that committee who will be addressing this particular problem.
Senator Hays: Thank you -- others on the panel wanted to comment -- Dr. Chopra?
Mr. Chopra: IGF-1 is only one of the indicators. It is also -- it is a factor and it stands as a growth factor. It is exactly what its name suggests. It is an indicator of growth of tissues, cells. rBST and BST is a growth hormone. Hormones are unlike any other drugs. They are like chemical switches. You give one, it triggers another one, another one and another one.
Some we know, some we may not know -- as far as rBST is concerned. What we do know now is some evidence that IGF-1 increases when you give rBST to cows, in the milk.
The question that Mr. Feeley is talking about, other agencies, the only other agency that I know is the FDA, which has already cleared rBST. No one else has come to any definitive conclusions whether IGF-1, the levels it produces, would be directly a causative agent of cancer or not. In fact, by itself, it is only circumstantial evidence, because when there is breast cancer or prostate cancer there is an increase of IGF-1 that is detectable. So that is circumstantial evidence, which is good enough.
The same individual who's published that study apparently -- what the other factors are that we may not even know about, that is what I was alluding to before, because not only IGF needs to be studied further, there are other factors of human safety that need to be concerned: antibiotic resistance, other hormones, other trigger mechanisms we know nothing about, and we know from the past experience, for example, diethyl -- DES was given to women and only 16 years later was found out. That is what we are looking at.
Senator Hays: I heard you talk about that earlier, that there are all sorts of horrible things could happen, but the question I had was on IGF-1 and rBST itself. We have talked about quite a bit before. I just wanted the details.
We have not authorized in Canada BST for use -- that is correct -- and why have we not? If you do not want to comment, that is fine.
In terms of the management differences, the management of differences between scientists -- I have commented that I have heard that and we will hear more about it, and maybe I could, if there is time, touch on the mastitis issue.
The Chairman: This will be your last question, Senator Hays.
Senator Hays: I am certainly not a scientist, nor a dairy farmer any more, but mastitis is something all dairy farms are familiar with. Hopefully you do not have any of it because of good management. That is the issue. The way in which you manage your dairy herd is usually the determinant of the degree to which you have infectious problems such as mastitis. Good health in the dairy herd is something we all pursue, and in our system I think we have a strong incentive to ensure that we have good dairy farmers.
Could you, Dr. Haydon, maybe put the growth hormone, the BST issue, in perspective in terms of the degree to which it is likely to result in more mastitis occurring or infections of that type in a dairy herd where BST is used, as opposed to this being a simple dairy herd management issue? If there is good dairy herd management, in terms of milking times, nutritional controls, monitoring the cow during the lactation, you should be able to reduce the incidence, under normal circumstances, to fairly low. What is the additional risk that rBST puts in a dairy herd?
Ms Haydon: To go back, the latest information that I had reviewed was way back in 1994, so I have not seen the most recent information that has been submitted. But at that time there were problems with -- as I say, there were three different companies' data that I reviewed -- there were problems with design of studies and this sort of thing, so there were even some studies that I did not receive specific information about how much mastitis had even occurred. Those cows would just disappear from the study, and there was no further explanation or follow-up. In other cases, I sometimes did not even find out what particular bacterial organism or mastitis organism was causing the problem because that work was not provided. So there were all sorts of variations in the amount of data that was supplied, but there certainly appeared to be an increase. I could not say from a statistically significant point of view, because sometimes there were not enough cows in which to determine that; sometimes there were not enough data provided.
But the general observation was yes, there was an increase in mastitis. It was variable in the different studies, so there was no particular consistency, but from my experience from large animal practice, I was very much concerned that this might be more of a problem than the dairy farmers wanted to actually face and try to deal with at that time. But as I say, my information is not the most recent.
Now if we look at the label, yes, there are indications on that label that there is an increased, or may be an increased, incidence of mastitis. There may be more quarters affected in the cows and there may be more cows affected. So the label itself indicates that the incidence of mastitis can be higher. And I am not sure that even a very good dairy farmer, who has excellent management skills, may not, in fact, run into difficulty.
Senator Fairbairn: I have a couple of observations, one of which has been made a number of times. rBST has not been approved, and in the past, any time I have raised the question of will it be approved or is it about to be approved, the answer has always been, "Until we are convinced that there are not negative repercussions to public health and safety, this will not be approved."
As far as the process is concerned, in reading the documents, it has had a fairly rocky process, this issue, in terms of both scientific debate, public debate. Obviously there may be some on the committee who can fathom the scientific reasoning and even language of the report. I am not one of those. My concern here fundamentally is one of public safety, and the fact that you are here and raising these concerns, there could hardly be a more open process than we are engaged with right now, and it will continue and we will hear other witnesses from the industry.
If I were a dairy farmer, I would be very concerned about some of the things that we have read and the questions being asked about the effect on the animals themselves. Then, of course, the questions surrounding this hormone, this growth hormone, on public human safety cannot be ignored. Listening to you today, they are not being ignored.
I have a couple of questions that I would like to ask. One is about the two reviews that are going on right now. I would like to have some indication from whoever would wish to speak as to whether you have confidence that the issues that are vitally concerning you, the questions that you have raised about the need for a comprehensive risk/benefit assessment on three factors -- human safety, target animal safety, target animal efficacy -- are you confident that the process now in place, as a result of many of the questions that all of you have raised, is a satisfactory process in itself, to have the two outside panels working on this issue? That is one question.
The other question goes back to Dr. Chopra's comments that I just would like to review to make sure I understood. Dr. Chopra, you were referring to the concerns about getting into a proper review of the data on this issue, and you referred to a comment that I believe you said came from an assistant deputy minister, to the effect that economics were a factor here in undertaking the fulsome kind of scientific study that you have been discussing, and that, in this event, economics might prevail over the science. I would like to get a precise comment back on this because that is something that would be of great concern to this committee. We have gone through, in Canada, other situations recently that have caused a great deal of anxiety, not just involving government, but involving research with hospitals and how funding is produced for that research, the partnership funding, and how sometimes this may conflict with the actual results of the research in terms of being able to make information public.
I would very much like to have another comment on what you said earlier because this is definitely of concern, and not only to the people on a Senate committee. The people of Canada must have confidence in our health protection system. In protecting our systems, whether it be with regard to rBST or anything else, I would not be comfortable with the notion that economics would prevail over scientific assurance.
Mr. Chopra: You are asking two questions, Senator Fairbairn. The first was whether my colleagues and I have confidence in the current process. We, of course, are not in charge of that. We do not know what materials have been given to the two external panels. We do know that we were asked, when the panels are appointed, whether the team would be willing to meet with them, and we said yes. But when it actually happened, the whole process was kept secret. We were not allowed to meet with them. We were not invited to meet with them. That has never happened.
Senator Fairbairn: The process is still ongoing.
Mr. Chopra: The process is still ongoing and the panels have been appointed. All the information we have is indirectly via the media and gossip and so on. We have never met with these panels. We do not know exactly what their qualifications are, who they are, and what their particular expertise is and how they will assess the data. We do not know what data they have received. We are not even sure whether this whole report has been given to them and what would be the basis. If they were to receive the same information we had received originally, then it is my contention that they cannot come to any conclusion. Unless you get into the actual data, no one can assess that. It does not require a Nobel Prize-winning scientist to assess the data. Data are data, as long as you have the data, but if you are not given the data you are not in a position to --
Senator Fairbairn: So you do not know, at this point, whether they are operating on that basis or not.
Mr. Chopra: We do not know what they have received and how it is going to be done, what the process is.
Second, the CVMA has already given a statement that they consider BST to be safe enough. The department and management have stated it many times, inside Canada and at international meetings, that there is no human safety risk, so therefore proceed. This current situation is only because we pushed the point. I personally pushed the point, to have it investigated inside the department. So if anyone says in the department the situation has changed and new information has come to light, that is a lie; that is not correct. That information has always been there.
Senator Fairbairn: I think my point is that obviously all of you have, in one way or another, succeeded in moving this issue forward and I guess we will have to wait to see whether the external committees do add another level of expertise to the concerns that you have raised.
I think you have answered my question and the answer is that at the moment they are there, they are working, but you do not have the information yet to be able to ascertain whether or not you have confidence in them, and at this point in time none of you have been asked to appear before those or contribute to those.
Mr. Chopra: The human safety division, under the Food and Drugs Act, has the mandate to do what we are supposed to do, and that information is available to the ADM. Why has the ADM not met with us? He is a medical doctor. He is an immunologist. He is an epidemiologist. These were the questions that he himself raised on immunology and teratology. Why would he not now sit down with us and say, "Let me understand the significance of this. Do I really need the external panels now? After all, I am the assistant deputy minister. I am a medical doctor. Why would I not sit down with these people?" He has never done that.
That process, in my mind, is a big question.
Your second question was if I could elaborate more on the -- what I said before. I was only speaking from my memory at a gathering of the department. And this is not the first time. The department is saying all over the place that the client -- and this is in writing -- the client now is the industry and we have to serve the client and, although we have to ensure that safety is there, our situation has changed. And the Gagnon report on drug evaluation says that point right from the beginning. Post-thalidomide, they talk about, things have changed. Now we have to have a new way of assessing drugs for people. So that process begins from the Gagnon report and carries on, and things have worsened. And now they are saying that report is there. We are only implementing the Gagnon report, the client is industry, and you people proceed. You do not have this mandate, you do not have that mandate, and go along.
The situation in the department is there is a whole lot of managers who have no science; they are managing. So therefore this conflict continues. There are directors general in the Bureau of Veterinary Drugs -- we have been there all these years, but for the last 10, 11 years there has never been a director who would be promoted from inside. What is wrong? They are always bringing them from somewhere else.
The Chairman: Thank you, Doctor, and thank you, Senator Fairbairn.
Senator Fairbairn: Could I just have one last word here? We will have other witnesses and we will certainly be asking these questions, but I guess the bottom line here is that the Canadian public is the client.
The Chairman: In the interests of time, I have three senators who wish to question and then I have started a second list. We just have to move along a little quicker, if we can.
I will go to Senator Taylor.
Senator Taylor: Dr. Haydon's testimony about stolen documents was covered quite well in Appendix III. The RCMP investigator was Fraser Fiegenwald, a rather famous name. Sergeant Fiegenwald, as in the other investigation, did not find anything, or said he did not.
Also, there is a letter from Dr. J. Z. Losos, assistant deputy minister of health protection branch, to Mr. Blair Armitage, our clerk, of October 15.
Do you have that?
That was given to me and I assume that if it was given to me it was given to everyone else this morning.
Dr. Haydon, I wanted to ask for your comment on the second last paragraph. I will read it very quickly if you do not have it.
It reads:
To the best of our knowledge, Dr. Haydon did not raise with Health Protection Branch management her concerns about the incident at any time between March 18, 1992 and April 21, 1998 when the Gap Analysis report was submitted to the Food Directorate management for review. Her note of June 17, 1994, to the RCMP was never brought to the attention of management and consequently no action was taken. Moreover, in her own note to file dated March 24, 1992, six days after the alleged incident, she made absolutely no reference to it either.
You would comment?
Ms Haydon: When my files were -- I will say stolen -- from my locked cabinets, it was in May of 1994, and the day I discovered there appeared to be a lot of things missing, I did not have time to determine what was missing, but the next day I did. So I was quite shocked. I went through to look and there were a number of file folders left but there also appeared to be a lot of things missing. It amounted to most of my work over the previous 10 years dealing with rBST reviews. So I decided that I would document this and send a memo to my chief.
I began drafting that. I came back after the weekend and again looked in the file cabinet and, lo and behold, there were some additional files back in. Some of them had been restuffed with different documents but not in any type of a sequence.
I redrafted my memo and sent it to my director or my chief, Dr. Drennan, with a copy to the director general, Dr. Sol Gunner at that time, and then the investigation began with the security group in Health Canada. Sergeant Fiegenwald was called in from the RCMP to assist in the investigation. After interviewing me, he took some of the files that were back for fingerprinting, and he also asked me to write statements on anything that I could recall or that I thought might have caused these documents to be removed. I provided him with the original, and I kept a copy for myself.
A few months later, in November of 1994, while I was away on sick leave, a member of the Health Canada security department called me and demanded that I provide my RCMP statements to her. She came to my home while I was at home on sick leave and demanded these. I have never seen those since that time.
There was a report that I just learned in 1997 that had been written back in November of 1994 by, I think it was an acting director in the security services of Health Canada, who I never met and who never interviewed me, so that was kind of a surprise.
Senator Taylor: One question: Would you say -- this is an opinion, I know -- the files that you had, were they pro rBST or anti rBST?
Ms Haydon: There were a lot of questions that I had asked, and they were reviews of the actual manufacturers' data, and that consisted of reviews from three different companies that I have been involved in. There were numerous what we call additional data letters, asking questions of the companies to provide additional information.
So at that point I was not recommending that the drug be approved from a point of view of safety in the intended species, or efficacy.
Senator Taylor: I gather if, after your research, people offered you rBST-treated milk, you would not want to drink it. That is all I want to know, yes or no.
Ms Haydon: Personally, I would probably decline.
Senator Taylor: Okay.
Senator Sparrow: To further that, you were taken off the study, you said. At what point?
Ms Haydon: After my files were stolen and the investigation. This was in May, 1994. I received no further assignments to review rBST submissions, and so I just assumed I was no longer going to be asked to review it, and that has been the case. Dr. Alexander is now the present reviewer of recombinant BST.
Senator Sparrow: It is an opinion now, but why were you taken off then?
Ms Haydon: I was not given any explanation as to why I was taken off.
Senator Sparrow: Did it indicate, following from Senator Taylor's question, that your report may be detrimental to the registration?
Ms Haydon: Yes. I was not recommending a notice of compliance at that time.
Senator Sparrow: Dr. Chopra, where is the barrier? Where did you see the barrier or the barriers to your studies being made? Who is stopping the studies going forward? It seems to me that there were gag orders given, whether the word "gag" is a proper expression or not. You must have an opinion of where those gag orders would have come from and why.
I guess it seems to me that there is something in your remarks of something very sinister going on. The words "secrecy" and "conspiracy" have been used, and I suppose you explained the word "conspiracy" in relation to that subject of what the conspiracy was trying to do.
This morning, it appears to me that the subject-matter is far greater than this particular rBST issue. If it is happening here, it has to be happening in other aspects of scientific studies within the department. I would like you, if you would, to comment on that. It appears to me that there is a cancer in the department itself that is stopping scientific studies coming forward or being made available to the department or to the public. Senator Fairbairn has talked somewhat about that.
It is the public health of the nation that is in question here, not only this issue. If you could comment on that, what the word "sinister" means within the department and the cancer within the department. It seems to me that when five respected people would come before this committee from the department, which is unusual, it does not mean that the meeting would end and say, "Well, some nut came to us to discuss this issue." There are either five nuts, or there are some very concerned people appearing before us.
I think the senators here are very concerned about the very broad aspect that we may be looking at. It may not be this committee that it will be looking at that broad aspect, but at least some type of an impetus might come from this committee for a much broader study into the problems that are existing within that department.
Mr. Chopra: Thank you. Senator Sparrow, your remarks quite accurately predict what is happening in the department. When we went to our union describing these problems, we presented this problem before the whole board of directors of PIPS, and at the time we described ourselves as the six little mice that took on the great big beast called the Government of Canada. And that is the risk we took on, only on our immediate area.
You are quite aware of the Krever inquiry. The whole country is aware. There is an RCMP investigation going on. There is a second RCMP investigation going on on the breast implant. That comes very close to my personal home. My wife, who worked in the department for also 25 years, was in charge of medical devices, pre-market review. She was the very first person in the whole country to raise questions about the breast implant. When she raised those questions, with the support of her director at the time, and chief, they referred the matter to Dr. Pierre Blais, who again was a brave soldier, honest, a very competent scientist. He took it upon himself to defy the department and say there is a problem that should be investigated. The company should be asked this question. We are already going back to the 1980s. What happened as a result of that? You all know that Dr. Pierre Blais was fired, but that is only part of the story that is known up to now. What happened to my wife, no one knows, although it is mentioned in a book called Safety Last by Nicholas Regush, what happened to her. She was removed from her job. She was harassed. She filed a harassment charge, and that harassment charge was proven. They would still not let her come back to her job. She got hit by a car in this whole process -- when she was removed -- and she had to take medical retirement. That hit me and destroyed my family 10 years ago.
Having worked in the department for 30 years, I decided at 20 years that it was irresponsible to remain silent. It was our duty; it is our oath to serve the public of Canada. That is the oath that we have taken. Therefore, everything that has to be risked, that involves and that is part of the duty. That is what we are doing. Just as a lot of sinister happenings in the Department of Health, there is people making statements that they are even trying to dismantle the Food and Drugs Act, as you have heard in the media, because they think they cannot handle what they have. Those are our concerns, people who are in the science and who are being told by people who are not scientists -- they are saying we have to move on post-thalidomide. We have to have new things, we have to make money, and those kinds of concerns. We just are unable to deal with it any more.
Yet, next month, I will be 65. I could retire, but I am not going because there is too much at stake at this point.
Senator Sparrow: Would you tell us, for the record, the questions and the answers we did not ask this morning, how crucial that is, because you may not be able to appear here again, and we have probably forgotten a couple of the most crucial questions we should have been asking.
Mr. Chopra: I just read this morning a comment in the media report that the Auditor General may be looking into this matter. We have just completed one more Auditor General's report, but that was -- we had heard they were going to do it. We all received a note that this was in process, but then we later on learned that it was being coordinated by a visiting ADM in the department, and then we never heard of the Auditor General investigation any further until the results came out. Those results are out. According to that report, it says everything is fine; there is no problem; the department is moving along quite well.
I imagine the Auditor General will probably -- if the media report is correct -- will probably go into some of the issues that we are talking about today.
Ms Mueller: From my standpoint, and I come from the therapeutic products program where we do drug evaluations, I have never encountered difficulties such as described by Dr. Chopra. It has always been an open discussion, where all of the evidence is laid on the table and we panel it amongst our experts and we arrive at a consensus.
What my concern is -- you were asking about the process -- whether or not these expert advisers, the outsider expert advisory committees, have been given sufficient information to draw conclusions regarding the quality and the validity of the data, because that is what you base your assumptions upon. This is, I think, the problem with many of the other bodies that have looked at the information. They have looked at summaries and, overall, it looks pretty good, but has anyone ever dug down back inside as to how was this data generated? Are these levels of IGF that are reported an accurate representation and do they represent the worst-case scenario? Are we measuring these levels at their optimum peak? The cows, they have been given, I hear, only one or two lactations. What happens after they have been treated over 10 lactations? Will these levels rise significantly? How are these levels sampled and analyzed and processed and compared?
I think this is the fundamental thing we have to find first before we can go on to decide what type of toxicity studies are necessary.
Mr. Feeley: I probably reiterate what Dr. Mueller has said at least. I am from outside the Bureau of Veterinary Drugs; I am from the Bureau of Chemical Safety. In most cases, we have not, in Canada, the same sort of situation as they have supposedly with rBST. Whenever we are dealing with food additives or packing materials or contaminants, it is usually an open discussion process with immediate managers. If there is still some conflict at that point, they will go to either internal or external review committees, much in the same way as BVD has done.
But I know of no instance -- but I have only been working with the Bureau of Chemical Safety for nine years -- that any sort of recommendation coming from internal evaluators has been bypassed or squashed.
As to the previous question regarding the two external committees, I am at this point of an opinion that because it is such an open process, that we have to have confidence in the overall decision-making that they will have available to them. Whether or not they will agree with the same questions that we have raised in the reports, you have, supposedly, two independent committees that are free to come to their own conclusions.
The Chairman: Dr. Mueller mentioned that there was, over time, no studies taken of the injection of the drug. Is there anything from the American experience, who have had this for a number of years now, that you know of that has had time with the drug in use?
Ms Mueller: Again, what I am questioning is exactly how these samples were taken, how they were processed; and, over time, the analytical methodology changes, it becomes more sensitive. Were they compared -- were the values compared -- with cows that were from the same herd and treated exactly under the same conditions to draw conclusions that the levels were not raised? It may have been they compared one herd with another herd and then the other problem is they mix the milk from rBST-treated cows with non-rBST-treated cows, and we get these bulk sample values, rather than the actual values obtained only from rBST-treated cows.
But I do not know. Over the years they are doing this post-marketing approval, PAMP it is called, but there again I am not sure how well the data is being collected and what the quality of that data is that we can draw any valid conclusions. They are saying the post-marketing does not show any further increases in IGF-1, or BST residues for that matter. But someone has to go back and analyse how this data was generated to make sure these conclusions are valid.
The Chairman: Dr. Lambert, do you wish to comment?
Mr. Lambert: Yes. I want to make a comment about the data provided to the external committees for review of human safety. I can say that the submission data was not provided to them because I have all of them in my filing cabinet up to now.
Without that data, we cannot find anything from the -- if we use only the summaries, we cannot arrive to the same conclusion as our team.
The Chairman: Are there any other senators who want to question on the first round?
Senator Chalifoux: In this letter from Dr. Losos, in the last paragraph he states that they will only issue a notice of compliance when they are completely confident that there is no risk to human health and that the product is safe for use in dairy cattle.
I would like your opinion on that. Do you feel at this time that enough information is given and do you also feel that enough studies have been done?
In your statements here, Dr. Mueller, where you state that in your opinion an accurate exposure assessment would better characterize the risk, and you determined the following should be investigated, if this was complied with, your recommendations here, would you then be satisfied that the documentation and that the test would be sufficient in order to assess this whole chemical thing? I myself, as a mother and a grandmother, am concerned also that we must be very careful.
Ms Mueller: Milk is the most basic of foods and it is essential for the development of children, particularly in their early years. We would have to give it the utmost scrutiny, and I think the process that we are doing now, revisiting the issues as we gain more information, is crucial. And depending on the answers to the questions that I have posed, then we could go to the next stage because then we know whether or not the exposure is really of concern. If it is really as small as the company seems to indicate, then we may have enough, but I am worried that it may not be as small, and that has to be established, and also whether there are any other kind of residues. As Dr. Chopra says, it may be more than just IGF and BST. Have we looked at everything? They have looked at the nutritional quality of the milk. They say that it is unchanged, but is there something else in there? Have we looked at everything? We should leave no stone unturned in this instance because we are dealing with the basic food stuff such as milk.
From there, once we know what the exposure levels are, we can determine the next steps in the toxicological assessment, and then that should include a risk/benefit analysis, and the question to ask is: What is the benefit to the consumer? If the consumer benefit is small, then the risk should be actually negligible or zero. Why should they be exposed to any kind of risk if there is no benefit, the milk is not of greater nutritional quality, or even like more of a social benefit or more people being able to have access to it because it becomes cheaper or whatever? So you have to look at all of these complex issues that are very interrelated in order to come up with the answer to should additional studies be required.
Mr. Chopra: To add to that, there is a line in the letter that we have received from the director general, Dr. Paterson, on October 16 when they released the whole report now. In that, he states that also attached are recommendations that were prepared by Dr. Lambert but were never endorsed by the four team members.
I for myself am willing to say now I do endorse all those recommendations. It simply says that this submission does not comply with the human safety requirements of the Food and Drugs Act, and the company should be asked to do such and such. So in essence, that is what Dr. Mueller is also agreeing to. It is just that because the way the process went, we were no longer able to meet together because we were ordered to change the report and we were -- would not change the report. Then the question came up: Are you now, in 1998, willing to make recommendations? Because that was not in our original mandate, to make recommendations. And so we, through Dr. Lambert, we sent the recommendations, although they were not signed. But if necessary, that is, I am willing to sign.
Ms Mueller: Just a quick comment. We were not really ordered to change the recommendations or the report anyway. I just did not want the committee to become distracted with the very important issues and the issues of rBST itself. That was the only reason why we produced these two different reports, but we were not under duress or coercion to do so.
Mr. Chopra: The basic recommendations are the same.
Ms Mueller: They complement each other.
Senator Chalifoux: Dr. Chopra, you stated that five or six little mice took on the whole federal government. Were you talking about the total federal government or just the department that you work in?
Mr. Chopra: No. It is concerning us, the six scientists. We're considered to be the little mice to take on the great big beast called the Government of Canada. That means my whole department, Treasury Board, and Parliament and Senate. We do not know who is making these decisions but we have stuck our necks out.
[Translation]
Senator Robichaud: You said that there was insufficient data. There hasn't been sufficient study of the effects of the hormone over several lactations and one can't really predict what will happen with usage over an extended period of time.
If you were supposed to get this information, was it going to come to you from somewhere that isn't under your control? Unless you yourselves were going to launch a whole series of control tests on animals, within Agriculture Canada or on some Canadian dairy farm. At the present time, this hormone isn't used in Canada.
[English]
Mr. Chopra: That is true. That is how our process works. We work on an honour system. The companies provide the data. We, unlike the United States, are not inclined to do the studies here in Canada under our supervision simply because it is expeditious and expedient, because we are a small country. If we had those kinds of requirements, no manufacturer will come to sell in our country. So therefore, we are willing to receive data from anywhere in the world, on the honour system, and we are simply the auditors of science and data are given to us and we evaluate and we argue on that, and we ask the company to, if necessary, go back and produce more. And if we are satisfied, we clear those drugs. If we are concerned about certain things, we put restrictions and precautions.
So that is the system in which we are operating and that applies exactly the way here. If it is for one lactation, two lactations, for four, for eight lactations, if that is what is necessary, that is what the company must do ahead of time to get clearance. And if they had done that during the last 10 years, they might have even had rBST on the road.
Ms Mueller: I think it is a fact, though, in the regulatory field, that we place quite a large reliance, or heavy reliance, on data generated by the manufacturer. And I was reading Senator Whelan's skepticism regarding this data, but there are checks and balances that we can use. We can ask the company to design the studies in such a way that we can determine, or have a fair level of confidence, that the data is a true reflection of the situation.
[Translation]
Mr. Lambert: Today, the problem is that we are lacking basic data on the toxicity of BST and IJF1 in particular. Concerning IGF-1, a two-week study was tabled and it too had methodology problems with the measurement of this hormone in the blood.
The company claimed that there was no absorption, but there were many problems related to the methodology. There was a difference of 67 per cent between the results obtained with the methodology used, so the methodology was not acceptable. This data is supplied by the company but doesn't appear in the summary. If we don't have access to all of the data, then we do not have access to this analysis.
Senator Robichaud: If we should be getting other data from the same source, we should ensure that they are looked at with a fine tooth comb, to ensure that the method used and the information given are the right ones.
Mr. Lambert: Yes, precisely. The fact that we get a study from the company does not mean that the product must be approved. It must satisfy very strict parameters and it must be valid from a scientific point of view.
[English]
The Chairman: We will go to a second round. We will try to keep this to five minutes each, because we do have to hear other witnesses, and we can only be here until two o'clock.
Senator Whelan: Mr. Chairman, the panel of witnesses, I must say that some of the things that you have told us about -- correspondence about people visiting one another, working together -- it sounds horrible to me, what is going on.
Dr. Mueller, you may have noticed my skepticism. Do not forget that I was a minister for 11 years, and research was my favourite topic. I know the things that we did and the things we did not do, and the things we stopped from coming into Canada, et cetera. So I have every reason to be skeptical when we become more dependent all the time on Monsanto and these companies doing the research for us when we know what the other doctor said. They are basically concerned, or not just basically, but they must make money, too. The economics of it are such. So I have strong reservations about less and less public research and big grants by Monsanto to Agriculture Canada for this, and big grants to somebody else from another company for that. I just wonder where our protection is and where our cows' protection is involved in this. There are no two humans, no two animals, that have the same chemical makeup, so no two react the same to a hormone if you give it to them. I have strong reservations.
I have 20-some questions here -- a lot of them have been asked -- but we do not have time. I hope we are not going to do what Senator Sparrow said. I know he is concerned because we have a really heavy workload, but I think we just scratched the surface here today on what is going on. I would ask each one of you, has anyone of you been lobbied by Monsanto?
Ms Haydon: I will describe the situation. I am not sure "lobby" is the correct word, but I did attend a meeting back approximately in 1989-90, and Monsanto representatives had met with myself and my supervisor, Dr. Drennan, and my director, Dr. Messier. At that meeting, an offer of $1 to $2 million was made by the company. I do not know any more about what became of that, but my director indicated after the meeting that he was going to report it to his superiors.
Senator Whelan: Anyone else have any comment?
What do you think of this outside committee, for instance, from the school of veterinary medicine? I want to make sure you remember that I am probably the only Canadian that has an honorary, full-fledged membership in a Canadian veterinarian medicine association for my contribution -- or our contribution -- to them when I was your minister. So I found what they have done. How can they be an independent committee, because their association has endorsed? If I understand correctly, they have endorsed this. You are all associated with the Canadian Veterinary Medical Association. Have you been involved in that endorsement of rBST?
Ms Haydon: I personally have not been involved, but yes, that is my understanding.
Senator Whelan: And they say, "We knew nothing about that."
Ms Haydon: I would like to add that just a few days ago, a list of the drugs that are under review in the particular division that I work in in Health Canada, in the Bureau of Veterinary Drugs -- we receive these fairly frequently. It is a list of the drugs that are presently under review. There is a great long list of submissions from the Monsanto company that are awaiting review, and have not been reviewed at this point, in our bureau. So I find it kind of interesting and unusual that the external panel, the Canadian Veterinary Medical Association, has been asked to review the drug. We still have not completed the review within our bureau.
Senator Whelan: I do not even believe I am in Canada when I hear that your files were stolen. Your files were locked up, Dr. Lambert? I believe you said, doctor, that one man, one person -- Dr. Alexander, or something -- is in charge with a key or something. He is totally in charge of that. What in the hell kind of a system have we got?
Mr. Chopra: In fact, after Dr. Haydon filed her complaint, security were called in. What happened was that, apparently at the recommendation of the security, the offices of the chiefs were now provided lock and key, so that when they go to the washroom they lock up their room so that someone else does not walk in and get access to anything else. It is a strange kind of environment that has been created. We are supposed to have access to everything because that is our oath of secrecy. We are supposed to look at the data and advise our minister. Here we are, kept away from the very information on which we make decisions. That is the way we are working.
Dr. Haydon talked about the $1 to $2 million from Monsanto at a meeting. The Fifth Estate did a program. They went and checked with that particular division chief at the time, who is now retired, Dr. Drennan. They asked him, "Was that offered?" He said, "Yes." They said, "Did you consider that to be a bribe?" He said, "I would say so." They said, "Well what did you do after?" He said, "Well, I laughed." They said, "After you laughed, what did you do? Did you report?" He said, "I did." They said, "Then what happened?" He said, "I don't know."
Senator Whelan: The letter we got last night, that was mailed or faxed to the Senate, they really responded quick to us. Your letters have never been answered. We have been getting them in a day now. This is wonderful, how quick it is coming. This is from the minister, and he says:
Again, let me assure you and your Committee members that rbST will only be approved when and if the Department is satisfied there are no outstanding concerns regarding safety.
I take it from that, his letter differs from Dr. Losos because he says "health standards." He does not just mentions cows. He means us too, I believe, us animals called people.
Mr. Chairman, I worked with a scientist after I was fired as minister of agriculture. You talk about getting fired. You ought to be in public life for a little while. Anyhow, the man who was in charge of all research for Western Canada, when he worked with me, we lobbied against rBST -- the only time I ever lobbied, and I was a registered lobbyist for that.
You cannot prove a negative. No scientist can do that. This is what they are trying to do, without enough data, without enough research, et cetera. I still maintain we should be doing more research. Now, for instance, Monsanto is paying $600,000 to Agriculture Canada to find a wheat that is immune to Roundup, I believe it is. I wrote to 10 universities. One of them told me to mind my business when I wanted to find out what strings are attached to the research grants they are getting. A couple of them called me and said, "You are on the right trail, but we cannot give you any information." They are scared to death. I am so proud of you people because you are not scared to death. If they ever do anything to you, let us know. Just let us know.
Senator Spivak: Mr. Chairman, I have a comment and some quick questions that I do not think can be answered here, but we want the questions out there.
First of all, the comment by Dr. Chopra that industry is now the client of the Bureau of Veterinary Drugs, I believe that was a quote from one of the managers. I do not know if that is accurate, but it was in the testimony before the grievance committee. The point is that I do not know what problem rBST is supposed to be solving. We do not need any more milk, and it does not increase the quality of milk; the inference about -- how should I say -- the client is an economic one and should be examined. Now, the questions I have are these.
We have a list, I think, of the documents that were given to the two so-called independent committees. On that list there is no record of the reports here. There does not seem to be. And, second, I am very concerned to hear that there is no raw data or they are not getting the raw data, because that was exactly the problem in the first place. In the United States, the FDA approval is based on some summary that turned out to be incorrect.
Now, the JECFA thing, it is the joint committee of the WHO and the FAO, I think -- the FAO and WHO committee. They have already said there is nothing wrong with rBST as of this year. The question to be asked is: What good are our reviews if the Codex Alimentarius -- I think that is it; I can never pronounce that -- says this is great? And that is binding now on Canada. And it turns out that the JECFA also based its findings on summaries that had nothing to do with raw data.
And furthermore, in the original report, the one you all agree with, in the June report, it says here: The IGF-1 exposure presented at the recent JECFA meeting in February, 1998, should be verified for neonates.
Am I pronouncing that right? In other words, what impact does it have on children? All of these questions bear very directly on the subject, not to mention the issue of the impact of the hormone-mimicking chemicals -- because that has just begun to be examined -- what effects the hormone-mimicking chemicals have on us.
Dr. Chopra, you said it is like a switch, throughout the scientific community that is now beginning to be a concern, and it is not tested.
First is the question of the independence of those committees. I will not even get into the membership because there is some question about the independence. But what data are they receiving? What about the JECFA data? What about the fact that Canada may not be able to do anything if the Codex Alimentarius agrees to it?
Could you just comment briefly on that? And the issue of children, I think that is very important because it is the kids here in Canada who will be affected by this milk more than anyone. And why are we taking this risk when we do not need this drug and it is not going to affect the quality of milk?
Senator Fairbairn: We are not.
Senator Spivak: I hope not, but JECFA has already approved it. Could you comment, anyone?
Mr. Chopra: JECFA is the joint expert committee that advises the Codex Alimentarius of the WHO. The question here is, this is only by agreement of the world community, to be able to come together, and if they can agree, then -- but that is not binding on any country that -- as has been proven in the last WTO hearings and the appeal that EU countries won.
However, there is a little catch left behind as far as rBST and other hormones in food production are concerned. Where both sides said they won was that -- one of the issues was that people making these, the countries making these statements, these decisions, should take science into consideration. However, every country has the independent, sovereign right to establish their own particular level of safety for their humans. So therefore, on that, the European Union won.
However, the matter still remains as far as the scientific parts are concerned. And that scientific part, JECFA has no binding effect. It is a jointly constituted committee of so-called experts. Then the question is also in our report: Who gets appointed? How do they get appointed? What are the influences that bring them together?
And in our own particular instance, that one individual's name has been mentioned and he's been the former director and then later on the industry spokesperson. And those kinds of issues are there.
So that is an international political issue that will have to be resolved at the level of the WTO and whatever those bodies are. But there, JECFA is not binding on Canada. What is binding on Canada is the Food and Drugs Act, unless that is changed.
Senator Spivak: Just one more quick question that I forgot. It has to do with the joint management advisory committee of industry and health officials within Health Canada which meets monthly to hear industry's concerns. And are drug evaluators invited? And is this common practice in the bureaucracy?
Mr. Chopra: No, the drug evaluators are not invited. In fact that is a confidential meeting only of our managers and industry. In fact, there's a joint chairmanship. At one time the question was if -- they call themselves joint, JPMACG. That's joint management program advisory committee.
And the question that really is -- what does "advisory" mean? Who are they advising? If the director general of food -- food directorate sits on it and the president of the animal health institute sits on it, and who are they advising? Who is advising whom?
So they said, well, you know, is it really a joint management meeting or is it advisory? Advisory to whom?
So that question has never been resolved. But the question is, do those people from the industry at these meetings make recommendations? And they become -- from time to time, they come, because the minutes or records are given, or somehow we receive them. And in there they are making constant recommendations, even to the point of where our department asks the industry whether we should be -- at the Bureau of Veterinary Drugs, whether we should have two divisions or three divisions to administer ourselves.
And the industry said, well, it is not up to us but we recommend two. And that is what was done. And this goes on.
And now the latest thing that we hear in writing -- it's a strong lobby point where the industry is saying that these people are causing too much trouble, and they came from drugs; they should be sent back to drugs, and that's where they belong. And that's in writing.
Senator Whelan: A short comment on Codex, our first meeting on this -- and I believe it was Dr. Paterson represented Canada at Codex. At this time when they had the Codex meeting, Canada abstained from voting, but no one knew what Dr. Paterson was voting on. I doubt if even the minister knew that.
These people go to these meetings and make these decisions by themselves. I had enough to do with world meetings that I know. I never knew what the others would do after I left. They made decisions that were completely contrary or oblivious to any comments, any instructions we had given them.
Mr. Chopra: This is the first time because Dr. Paterson was tied up in our hearings, because he had been subpoenaed to the PSSRB hearings. And Dr. Yong and Dr. Lachance were in Washington at that same time. As far as we know, this is the first time Canada abstained -- up to now -- because we were making statements before the staff relations board that there are problems. And that, itself, was an achievement, to be able to go before a labour board to put this on display. And this -- in fact the horrendous difficulties we had to get to that point.
And the decision is still awaited but, at that time, that is the first time that Canada abstained. And Dr. Yong was there. Up to now, he's been saying there is no problem of human safety. So we do not know where the department stands. As far as we are concerned, that issue is still open.
Senator Whelan: Australia and New Zealand, though, do not allow the use of rBST. Their representatives voted with the Americans at Codex.
Senator Stratton: I would like to remind folks around the table that while Canada does not need milk, the rest of the world does. I would like to try and put a bit of a fence around what we have talked about this morning, if I could.
First, I refer to the questions asked by Senator Chalifoux on the presentation prepared by Dr. Mueller and Mr. Feeley and your recommendations in that presentation. If you had those recommendations carried out, you would be satisfied.
Second, I refer to the question raised by Senator Sparrow as to the opportunity, as it were, to explore further the questions of your well-being and what is going on in the department, whether that is worth further study.
Finally, I refer to my question or suggestion to you. I would like to, on behalf of the group here and particularly the people of Canada, congratulate you for appearing here today because it took a lot of courage. On behalf of the group here -- and, in particular, on behalf of the people of Canada -- I should like to congratulate you for appearing here today. It took a lot of courage to do so. It is not something that is easy to do, particularly when three of you took the oath. It is very unusual for that to occur.
I wish to re-emphasize again that the members of the House of Commons come and go for the most part; ministers come and go for the most part. What remains are the senior levels of bureaucracy, and the Senate. Part of our role is to protect you, particularly because of your courage here today, for having come forward. I wish to assure you again that if any of you have a problem down the road -- not just six months, or one or two years, or five years from now -- please come forward to us.
Mr. Chopra: I have one comment on the statement that the world needs milk. I have some relevant information, which I hope you would like to hear.
First, about one year ago, India -- and this is an unexpected revelation to a lot of people -- became the second largest producer of milk in the world and is now ahead of the U.S. as a milk-producing nation. With the size of population it has, this means that it has four times the room to grow -- that is, if they have the same per capita milk consumption and production.
Second, technology has now become available where you can dry whole milk with cream in it and not change its taste. It was said that because New Zealand does not allow rBST, it has an advantage over Canada and the United States to sell its dairy products to Europe because an 18 per cent surcharge is not charged to them. When that happened one year ago, New Zealand was short of milk that they needed to sell to Europe. Where do they go to buy it? They go to India to buy dry milk. With the technology that is available now, there is already joint tie-ups to produce milk in India that is rBST free, with the New Zealand investment. They are already running ahead of us.
My country, Canada, where the dairy industry is so hugely developed, is already in the hand of one company that is foreign. If things continue the way they are, production could be taken away. We do not produce much cheese any more. We do not produce anything else. All we do is milk cows and send the milk somewhere else. Therefore, the biggest consumption of milk does not come from drinking, it comes for other uses. That can easily be taken to Mexico or to Argentina or to anywhere in South America, India, and so on. If we do not protect our trade interests and our jobs, we are about to lose them. That is what we are facing now.
The Chairman: Thank you for that information.
Senator Hays: I was going to ask more questions about IGF, but I will follow the precedent of Senator Stratton in trying to put a fence around this issue.
We are getting quite far afield, Dr. Chopra, talking about exports of milk, foreign ownership of processors, and so on. I look to the panel to try to narrow the issue here. In my first question, I confirmed that there is no rBST or BST authorized for use in Canada and no one said anything. I assume that is correct.
The issue of management of differences among scientists who are responsible to make scientific decisions is a matter that you have raised and have concerns about, which we have noted, but would not you agree that the issue before us is the following: Namely, where are we in terms of approving or not approving rBST for use in the Canadian dairy industry? Is not that the issue here today?
Mr. Chopra: That is the issue. We have made the recommendation that we are nowhere close to issuing notice of compliance. That recommendation has been made to the department and to management. Management, I presume, wants to look at it, as well as get some external opinion. We do not know what more they will gain, but that is what it says, namely, that the company did not do certain things that should be done and that is the recommendation.
Senator Hays: That is good. I am still having trouble with some of the scientific aspects. You are scientists and can, perhaps, help on IGF. Perhaps one of you could describe how that occurs in the body of an animal. We are talking about humans or cows here today. I guess it has to do with the endocrine system. I should like to know a bit about it. I do not want to take a lot of time, but could you give me three or four minutes on how it occurs and how it is eliminated?
I remember early in my time as a senator, working on the BST issue, that we were told we were working on it in research stations in Canada. The question then was: Is it best to produce and administer to the cow? You used the word "treated." "Treated" implies to me that there is something being treated. It is administered to the cow to achieve an economic result -- that is, higher milk production. It is not treating anything. I do not know whether or not you would agree with that.
In any event, the issue is IGF-1 and how it gets into the system and how it gets out. I ask this to narrow my own perspective about what we are concerned with here.
Mr. Feeley: The administration of the bovine growth hormone is distinctly different from a human growth hormone but both produce the same effects. It is outlined in the reports. If you administer the bovine growth hormone through a non-oral route to cows, one of the first signs you see, besides some nutritional aspects, is an increase in lactation, in milk production. You will see the same thing in humans. If you administer a human growth hormone, you will see the same sort of increase in milk production by women.
There are also localized effects occurring following the injection of bovine growth hormone to cows, which results in a systemic or all-over-the-cow production of IGF-1, particularly in the mammary gland. With the increase in milk production, you get IGF-1 residues in the body, but it is also being eliminated when the milk is collected. This is the component that means IGF-1 levels will increase following bovine growth hormone administration in cows.
IGF-1 functions as a multi-potent growth promoter in humans. It is produced in the liver, in the kidneys and in the GI tract. For infants who ingest either human breast milk or cows' milk, it functions to allow the GI tract to digest certain proteins and nutrients in the milk for better absorption into the systemic circulation. The question posed is that if the IGF-1 is potentially having a localized effect, which may be its intended cause, is there a potential for that effect to occur in humans?
Dr. Mueller asked if the increase in the IGF-1 is above and beyond what you would normally expect to see in humans, because human milk contains IGF-1. The proposition by the petitioner is that the levels that you might get in terms of an increase in IGF-1 production due to administering cows the bovine growth hormone is not greater than what you see in human milk. That is the information that FDA and JECFA, and I guess the Bureau of Veterinary Drugs, have also evaluated.
When you see an increase in IGF-1, is it possible that it will increase the exposure for the infant or the people consuming this milk?
Senator Hays: And always within the system the hormone is being produced and eliminated?
Mr. Feeley: Yes.
Senator Hays: So the extra is what we are concerned about here and we are not sure of the answer at this point, or at least you are not.
Mr. Feeley: The idea is that -- and what had been considered at some of the external panel meetings, and I am not sure what they are considering in the two that have been implemented by the health protection branch -- is that if you are given a hypothetical situation with a maximum increase in IGF-1 in milk, and if you state that 100 per cent of that IGF-1 is actually absorbed from the GI tract and gets into the systemic circulation of a human and can potentially cause growth-promoting effects -- because this hormone is being produced continually in a human -- what is the contribution to that daily supply? The information right now says it is less than .1 per cent.
But I think it goes in part to what Dr. Mueller has stressed, that what is probably required is very up-to-date and recent exposure information. Just how high does IGF-1 get in cows that have been treated chronically with rBST? What the available experimental data has not actually shown is what exact percentage of that IGF-1 would be expected to bypass the GI tract environment and produce systemic effects. There is also, as outlined, a possible question that if it is surviving digestion, then it could produce a localized effect. Whether these localized effects would be harmful or beneficial -- I think if some of the questions had been answered that we have raised, we would have a better understanding of this.
Mr. Chopra: To add a little to that, because you are asking a scientific question, no one knows exactly what IGF-1's role is; whether it causes cancer or does not cause cancer. We know that it is a growth factor that does appear in the body wherever tissues are growing and being sloughed off, usually on the surface of tissues. And the mammary gland is one of those tissues. When the cow is parturient it puts on extra cells and milk is produced and cells get destroyed and this goes on -- the cycle.
Senator Whelan: The cow consumes way more food, too.
Mr. Chopra: Of course, but that is a given. So therefore IGF, whether it is a by-product -- it is certainly a by-product, and whether it then goes on to do something else -- and we also do not know what else may be produced, as Dr. Mueller was saying before. So that IGF-1 is, right now, the first indicator that has appeared in addition to rBST itself. And the question that we are asking is what is the significance of this IGF, what other things may be present, and how can we determine it; can we determine that in one lactation, two, three, four or 10? That we have to find out. Will it maybe come down in the second or third lactation?
So these are valid questions that have to be studied very thoroughly on an epidemiological basis in the dairy herds, and very objectively and scientifically. Not the way it is being done in the United States right now where there is this study where you give to whatever cows you want to and then you pool the milk and then you look for antibiotic residues and IGF in there. How are you going to determine that? There is no way to have scientific information coming out of that and say everything is all right.
You will have to then wait for 10 or 15 years. Maybe there will be no effect on humans. I am not saying there will be. Maybe in 15, 20 years there will be no effect on humans and rBST will be fine. But the question still remains. The cow itself that is receiving it is a sicker animal than it was before you started to give it. Therefore, it has all kinds of -- there are 20 adverse reactions on the label. Haemoglobin goes down, its skin is all inflamed, its hooves increase in length and all kinds of things happen to the cow.
When that happens -- under the Food and Drugs Act the law says that you will not serve or manufacture food in a filthy environment. You know, if hair is present in your food, it will not make you sick or kill you or anything, but under the law it is not allowed. In this situation, what you have is a filthy milk production factory called the cow, receiving rBST. That is the situation that is emerging. It is not just IGF. There are many, many other things that are going with it.
Senator Hays: So you say administering this makes the cows sick. On what do you base that?
Mr. Chopra: It is on the label. There are almost 20 adverse reactions. By giving rBST you expect these things.
Senator Hays: But is that sickness or is that a result of the increased levels of a hormone in the system of a cow? You are equating that to sickness and I am wondering how you are doing that.
Mr. Chopra: If mastitis occurs --
Senator Hays: But rBST does not give the cow mastitis. Higher levels of milk production require higher levels of food, as Senator Whelan said.
Mr. Chopra: No, more tissue.
Senator Hays: You do not make milk out of thin air. There is a higher through-put through the cow, which involves stress on the cow, but we do that anyway through genetic development. We want high-producing cows. To follow the argument you are making through, we should have cows producing less milk because they will be healthier. What we want to do is have the right balance and this is something that may or may not have value.
I guess I am surprised that you equate --
Mr. Chopra: Please allow me to explain. That is not what I mean. I am saying that high-producing cows have been genetically bred and they are healthy and we maintain them as healthy cows. You look after their health, you feed them well, you keep them under a proper climate and all those things that you are supposed to do. This has been done over thousands of years.
When you do that with a drug, you do that in one lactation and you continue to give that drug every two weeks and then its skin is blotched up all over the place. You get reactions, one of the reports shows, as big as the size of a dinner plate on the back of a cow. Then you get this elongation of hooves; you get a drop in haemoglobin. If someone's haemoglobin drops, that is an illness.
Senator Hays: But those things can happen in changing the nutrition, the protein.
You have answered the question within the time we have. I will thank the chairman and thank you for your answers.
Senator Mahovlich: We import quite a bit of milk in this country, besides producing it. Does the milk that we import contain any rBST?
Mr. Chopra: At this time it is only about 1 per cent.
Senator Spivak: We import 1 per cent?
Mr. Chopra: I think, of the total, some of which may contain --
Senator Mahovlich: Oh, some may contain it?
My experience with milk goes back to 1968 when I was down in Detroit. In all fairness to the United States, I think they do an extensive study. I was at the University of Michigan in Lansing and a close friend of mine, Dr. Kozak, was a scientist. I do know whether you know him. He has been studying milk and the effect that cancer has on different milk products. One exam that they were doing was on mice. He had human milk from a woman and milk from a cow. He called me over one night to show me the different behaviour on the mice, and there was quite a difference of behaviour. This was back in 1968.
My point is that the Americans do an extensive study. It is hard for me to believe that there is anything wrong with their milk in the studies that they do throughout their universities in the United States.
In Canada, we do not have the access. I am sure that a lot of these universities are supported by large corporations and they get their moneys, and right now I believe Dr. Kozak is down in New Orleans at the university there doing another study. They received another grant, and he is doing another study there.
With all their studies, to find something wrong such as you are claiming, is hard for me to understand that they are letting this go by. It is hard for me to believe. My point is challenging some of the problems.
I am sure that their milk is still being produced in that manner. Does anyone want to express any confidence in the drug, or are you all against it?
Ms Mueller: I do not think we said that the data is necessarily wrong, but I would like to have it verified that indeed the results that they are reporting and the summaries that they are using to draw their conclusions are based on accurate data of the sampling techniques initially, how the data was generated initially. That is all.
Senator Mahovlich: I believe they have been using the milk since 1972.
Ms Mueller: rBST milk, no. Since 1994. There are disparities in the states as to which ones adopt the rBST and which ones do not. Then it gets all mixed up. We are not really sure exactly where the milk is coming from in the end.
Senator Mahovlich: So they do not want to share their data with us. Is that a big problem?
Mr. Chopra: There are other differences. Canadian milk is of a higher quality, if I can be so nationalistic.
There are two kinds of mastitis. One is infective mastitis -- in other words, caused by bacteria -- and mastitis that is non-infective where a high-producing cow gets -- the udder or mammary gland gets inflamed.
Because cells that produce milk have to be produced and they get sloughed off, and they have done that, and so eroded cells can appear in the milk when the udder is inflamed.
There are standards that Agriculture Canada here and there are supposed to use. I believe their standard is 750,000 cells. If your milk contains more than 750,000 of these damaged cells in the milk, then that milk should be rejected. I believe in Canada it is 500,000 as the maximum limit, although our farmers try to bring it down to less than 150.
These are the kinds of differences that do exist in the U.S. producing patterns and Canadian producing patterns.
The kind of question you are raising is: Do we have confidence in the U.S.? We are not in a position to comment on that. What standards a foreign jurisdiction makes for its population is up to them, but for Canada, those are the standards that we are following. Beyond that, there is nothing much more we can say at that time. When you give a drug that will stimulate and that is accepted on the label to take it to a higher level, effectively what you are getting now, the possibility of even if there is a dead cell that is non-infective, some puss in your milk.
Senator Mahovlich: We have that problem in human beings also. In sport, they are feeding athletes now a drug that stimulates them. This is quite common. Dr. Feeley, did you want to say something on that?
Mr. Feeley: It has been pointed out that it may be premature for the representatives of these witnesses to comment, particularly on the aspect of efficacy and animal safety, because there is a post-approval of honouring process that is supposedly going to be reviewed by the Bureau of Veterinary Drugs. I have not seen the list of the documentation to be provided to the expert panel committee, but particularly the one made up by the CVMA, obviously they will consider all aspects of illegal residues of antibiotics, somatic cell count or dead cell counts in milk, mastitis in cows, and come to, hopefully, some independent and open sort of evaluation process decision.
Senator Sparrow: We are talking about standards in different countries. Are you satisfied with the standards that we should be adhering to in Canada? I appreciate that would always be an evolving process, but at the moment, are our standards adequate?
Mr. Chopra: Ours are the best in the world.
Senator Rossiter: IGF is an insulin-like growth factor. What is the effect on the human body, particularly a person who has a tendency towards diabetes because of genetic factors, or has diabetes, of introducing another type of insulin into the body?
Mr. Feeley: The supposition is that an insulin-like growth factor produced by a cow, because it is a protein comprised of separate building blocks, the structure of it is nearly identical to the human molecule. Ideally, if the one IGF from cows should react in humans.
Senator Whelan: But it is not identical.
Mr. Feeley: Also, conversely, human diabetics cannot be treated orally with IGF-1. They have to be treated by subcutaneous injection.
Senator Rossiter: But there is an oral medication for early diabetes.
Mr. Feeley: Do you mean insulin?
Senator Rossiter: No, not insulin. There are pills.
Mr. Feeley: I am not aware that they are functioning through, say, an IGF-1 type of mechanism. There is a small amount of experimental information -- now this is in mice or experimental species -- to show that the potential absorption of IGF-1 from the gastrointestinal tract is actually reduced in a diabetic animal model. Once again, that is relatively preliminary, and is the absorption of IGF-1 in experimental animals the same as might occur in a human diabetic?
The Chairman: I should like to thank the witnesses for appearing here today. We appreciate the time you have taken. You certainly have helped us to understand the issues that are before us. We thank you very much. We have had quite an in-depth time this morning.
The committee adjourned.