Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 35 - Evidence - Morning sitting
OTTAWA, Monday, May 3, 1999
The Standing Senate Committee on Agriculture and Forestry met this day at 9:13 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 Eugene Whelan (Deputy Chairman) in the Chair.
[English]
The Deputy Chairman: Honourable senators, in March, the Agriculture Committee tabled its interim report in the Senate. While we addressed many of the issues involved in this study, the committee also identified outstanding questions that needed to be addressed.
Today we will hear from the scientists from Health Canada who reviewed the department's evaluation of rBST to date. As promised during their last appearance before us, the committee wishes to assure itself about the concerns these public servants then expressed about the management of scientific disputes within Health Canada and about their own careers in relation to their appearance before this committee.
Following that, we will hear from representatives of a variety of interest groups who have expressed a continued concern with rBST, despite the decision of Health Canada to deny approval of rBST, based on its health effects on dairy cattle.
Our first witnesses this morning are Mr. Chopra, Ms Haydon, Mr. Lambert, Ms Mueller, and Mr. Hindle. Please proceed with your presentation.
Mr. Steve Hindle, President, Professional Institute of the Public Service of Canada: Mr. Chairman, honourable senators, I am here to introduce Drs. Chopra, Mueller, Haydon and Lambert, and to indicate that the Professional Institute continues to be concerned about the management of science in government. As a result, we continue to support our scientists when they believe that something is taking place in a particular department that requires airing in public.
We are pleased, Mr. Chairman, that you and your committee continue to be concerned about the management of science within Health Canada, particularly the effects of drugs on animal health as well as human health.
The scientists are here today to explain some of the additional documents they have presented to your committee. With that, I wish to indicate that the Institute continues to be very supportive of what the scientists are doing in their professional life, and also very supportive of their efforts to ensure that there is adequate public debate about the management of science within Health Canada.
Dr. Shiv Chopra, Health Canada: Honourable senators, the last time we appeared at this committee, issues relating to rBST were brought to your attention at your request. There were also issues relating to other drugs and general management of science at Health Canada, which were raised here as well. Following that, representatives of Health Canada and the Deputy Minister of Health, Mr. David Dodge, appeared here to address those very issues. Since then, we believe you have received a letter from Mr. Dodge in which he states that he is looking further into the matter and reporting on it. It is our intention to go through that letter. It will facilitate the process and save us a significant amount of time.
Mr. Dodge, in his letter to the chairman of this committee, Senator Gustafson, on February 18 wrote about the issue of the human and animal health safety of rBST. He said that the drug was issued a notice of noncompliance because of concerns regarding the animal safety of that drug, as indicated by the animal safety panel. However, he adds that there were no concerns about human health safety as determined or reported by the human health panel under Dr. MacLeod.
Dr. MacLeod appeared before you on April 26, 1999. He indicated that, in his opinion, there were no concerns relating to human health safety. That remains confirmed from his point of view.
I also appeared on that same panel, as you recall, Mr. Chairman, and I had serious reservations about the committee, something which I will go into in greater detail today.
Mr. Dodge addressed other issues. He spoke about document shredding, as well as the PSSRB hearing of our grievances and complaints as put forward by PIPS, about which our president was talking a few minutes ago. Mr. Dodge claims that the complaints were dismissed. The implication is that there was nothing in the complaint. Therefore, that was addressed and finished.
In regard to paper shredding, he said that the department was cleared completely and, thus, the complaint is not worthy of note.
Mr. Dodge went on to talk about the future and how he intends to strengthen the Bureau of Veterinary Drugs. He spoke about the issues starting in the 1990s, such as the backlog, and the behaviour of scientists, et cetera.
We should like to address these points. Mr. Dodge has also attached to his letter a document entitled, "Strengthening the Bureau of Veterinary Drugs: A Report and Action Plan." This document has been shared with us, as he has indicated, through the Assistant Deputy Minister, Dr. Losos.
In this document, there is mention of the issues at the Bureau of Veterinary Drugs starting in the early 1990s. He explains what the problems are and mentions that there have been serious differences of opinion, management troubles and so forth. I should like to address that issue right away. It is based on the fact that there was a report, called the Gagnon Report, which reviewed the entire drug regulatory process and discussed the future.
They mention the drug and safety area. I have with me a document, which was issued probably in 1993, although it is dated 1991-92. On one of the pages there is talk about moving toward comprehensive risk-based drug assessment. He addresses how we will be addressing drugs and products in the future, which will involve refining the current risk-benefit analysis methods and that we will be using risk-based drug licensing in the future. The classification of drug submissions will be based on an assessment of their level of risk.
This indicates that they will be taking more risks in the future. However, no one has ever told us that that is happening. Therefore, before any revision to the act and regulations has occurred, they have already put in practice policies that will be handled in that manner.
In order to do that, a whole series of appointments of people above us at all levels were made. They spoke about how we should manage ourselves. Essentially, that was the cause of the trouble in the 1990s around the Gagnon report.
A special deputy minister was brought in from the Treasury Board whose job was to construct what was called a national pharmaceutical strategy for Canada. That person is now the director general of the Drugs Directorate, which is now called the Therapeutics Directorate.
Up until today, no one has ever told us that what we used to do or what we are doing today to assess or evaluate drugs and their safety is wrong and why it should change. No one has done anything like that.
We are old timers. We have been under that system for a long time. We had to assume that it is our mandate and that is how we must work. Any time we make a recommendation we become the bad guys. Suddenly, we are told that this is not the way to do things. That is the reason for the conflict.
In the Bureau of Veterinary Drugs, since 1990, we have had 10 different directors and acting directors. Dr. Lachance is our new director.
Dr. Ritter will appear before you today. He was also a director of the Bureau of Veterinary Drugs. Although he is not a veterinarian, he was brought in as the bureau director. He held that position for a number of years. You may wish to ask him questions about the things that he has done outside the bureau. However, what he did inside the bureau is worthy of judicial inquiry. There was a conspiracy against us, and me personally. A number of things that were done are worth looking into. This has been the subject of other court hearings and so on. Thus, what I am speaking about is not something from my memory and imagination. These are court documents that I am talking about.
After a director would leave, generally, either a chief or a director general would become the acting director.
The next director who was brought in from Agriculture Canada was Dr. Timothy Scott. It was during Dr. Scott's tenure that one of the external investigations from Price Waterhouse was conducted. There was pressure from companies, which said that the department was in a significant amount of trouble and needed a change in direction and many other things such as cost recovery and a director. Therefore, they brought in Dr. Timothy Scott as director. Dr. Timothy Scott was, if I may use the word, a perpetual phantom in the department. He never stayed. From the time he came, he said he was sick, and this process went on for close to two years. Ultimately, even when he came back to work, he did not come in as director but remained as a special advisor to the Director General, Dr. Paterson, who himself became the acting director for many months. In between there were Drs. Landry and Yong who, for four months each, were acting directors. During that period we had even more trouble. There was pressure to pass drugs -- not only rBST, but antibiotics and other hormones. There were serious problems with hormones that could cause cancer, and now the report has come out from Europe saying that, yes, one of the hormones, a beef hormone, has been reported to cause cancer. That was in The Ottawa Citizen on Sunday. After all this, another assessment was done. This was KPMG's report, which was totally flawed. People did not participate in it. It was a made-up report, again calling us troublemakers or implying that we were the troublemakers, and saying that something had to be done.
Finally, the newest director, Dr. Lachance, was brought in by transfer from Agriculture Canada on April 1, 1998. The first thing we asked was whether Dr. Lachance was a veterinarian. No, he was not. Did he have any experience in drug evaluation? No, he did not. He was a manager but his training was in metallurgical chemistry.
When the Director General brought him in to introduce him to us, the question we asked was, "Did you follow any particular process of appointment? Did you go through the Public Service Commission?" We were told, no, that this was just a transfer, a swap, to replace Dr. Scott.
Dr. Lachance got up, looked at us, and said, "These are my qualifications. I am a chemist. I have been a manager for many years. I see about 60 per cent of you are visible minorities. I like visible minorities." The background of that is that the department has been indicted in court and confirmed to be practising severe racism against so-called visible minorities, and I was the person carrying this on since 1990. The Human Rights Tribunal has ordered changes in the department. Dr. Lachance was probably addressing one of those situations.
Following that, there were other problems. One of our colleagues was verbally assaulted by Dr. Yong, and he filed a grievance. At the grievance hearing, in the presence of all people, a union representative asked Dr. Lachance why this was happening at the Bureau of Veterinary Drugs, and Dr. Lachance said, "There is too much visible minority mentality here."
Do not forget, this is the Dr. Lachance who ordered us to change the Gaps Analysis report. This is the Dr. Lachance who has placed gag orders on myself and Dr. Haydon. This is the Dr. Lachance who has now filed an affidavit because we have gone to Federal Court to fight this matter of the gag order because we feel that, as citizens, we have rights, like everyone else under the Charter of Rights, to speak about food safety. We may be more knowledgeable, but we are citizens of the country as well. In addition, as knowledgeable public servants who work under the Financial Administration Act, we feel we have an obligation to speak the truth when the department does not do anything.
Those are the issues that Mr. Dodge has addressed in his letter, speaking about what he calls our "unprofessional behaviour." I do not know what he means by that.
They speak about a backlog. Let me say a word about that. The Gagnon report identified the Bureau of Veterinary Drugs in its deliberations, and said that this is a model bureau; the best in the whole branch. Nevertheless, it said that veterinary drugs are different from human medicine, and that we should be transferred. We were then transferred from Drugs to the Food Directorate. That is where the problems happened. There was no backlog, or no problems. This backlog is an engineered, made-up thing. The companies say there is backlog. They induce delays on purpose and then they get their lawyers to send letters saying that, because the drug has been sitting here for so long, it should be cleared. That is how the drugs have been cleared.
There have been some very serious omissions with regard to drugs like beef hormones -- and Dr. Haydon will speak about it -- where we have shown very serious consequences in cattle that were given beef hormones. I was the acting chief in that division at the time, and I took this matter to Dr. Landry, who was acting director. I said, "This is what we are observing. There are serious problems. The uteruses of these heifers are enlarged. The thymus gland has regressed." The thymus gland is the organ that controls your entire immunological system. That tells you something. When I took this matter to Dr. Landry, he said, "So what? They will be slaughtered." I said, "For God's sake, they are going to be eaten by people."
These are the kinds of things they say exemplify unprofessional behaviour on our part, not on the part of the department.
In the same document, they say that, from now on, there will be, on a regular basis, a standing expert advisory committee on veterinary regulatory science established for BVD. That is probably in place. In other words, whether we say no or yes, they will go to this committee and get the approvals for drugs. There will be expert panels. We have had two expert panels for rBST. I should like to talk somewhat about those two expert panels.
First, the human panel that appeared here last week met with the departmental representatives on July 20, 1998. I have in front of me -- and you have all been given copies -- the agenda of the meeting. Present at the meeting were Dr. MacLeod, Dr. Paterson, Dr. Lachance, Mr. Joel Weiner, and some others from outside whom I do not recognize. They are probably from the panel. The overview of scientific documentation was given by Dr. Yong. Dr. Pollak was not there, but he participated by teleconference.
You asked, Mr. Chairman, why Dr. MacLeod and his committee did not meet with us. He said that they chose not to. I will say that they were prevented from meeting with us, because, with the agenda, there is a contract attached. The contract states that Health Canada will be available to provide timely scientific briefings at the discretion of the panel chair. It also states that Health Canada will undertake to contract for the services of a research assistant to work under the direct supervision of the panel chair. That research assistant was the graduate student who wrote the external panel's report.
Should the chair or any panel member wish to use or make reference to any part of the human safety Nutrilac report, permission from Health Canada must be obtained. The contract states that they must have Health Canada's permission to quote from the report or get the report or meet with us. Of course, we were not allowed to meet with them. Yet, the minutes show that Dr. Paterson had asked us, when we appeared with our final report, whether we would be willing to meet with the external panels. We had said "Yes." This meeting was handled in secrecy and we were not given any information.
This contract was prepared and already signed on February 17. The name of the lawyer for the department was Mr. Weldon Newton. He was brought in simply to write this contract because he had already retired.
I should like to go now to the letter that I mentioned last week at the hearings, in the presence of Dr. MacLeod. It is a letter that he wrote to Dr. Rod MacRae, Coordinator Community Services Public Health, Toronto Food Policy Council. What happens here is quite telling. First, Dr. MacLeod says:
We also contacted a range of scientific organizations in Canada with an interest in biology and medicine and invited their submission of scientific information relevant to our topic.
You may recall that I asked Dr. MacLeod, "What other scientific organizations did you contact and what information did you receive concerning Nutrilac or rBST?" He did not answer that question. Perhaps you can go back to him.
He then goes on to say:
...our mandate does not extend to an examination of regulations governing the dairy industry.
I asked if he knew that the Food and Drugs Act requires human safety to be applied to the dairy industry. Obviously, Dr. MacLeod did not know that aspect of the Food and Drugs Act. However, he said that was not their mandate. That was in the sister panel. I continued to insist that the sister panel is not for the safety of the cow. The sister panel or the animal safety that we assess in Health Canada is for human safety. It may be important for the farmers to protect the health of the cow, but not the health department. If that were the case, that part should belong in Agriculture Canada.
The efficacy of the drug and the safety of the animal, toxicology, et cetera, is for the purposes of human safety, not animal safety -- that is, not for the cow's safety. That went over the heads of the medical panel altogether.
Dr. MacLeod then goes on to say:
We did receive a copy of the GAPS analysis in July and this will be part of our review. The version circulated to our committee was edited to remove personal references, but as far as I know it contains complete scientific information.
I will repeat that phrase, "as far as I know." It did not occur to him to make a telephone call to anyone to ask, "Does it contain all the information? Do you have any concerns?"
For scientists, never mind anyone else, it is important to ask such questions and to do a thorough job. If someone gives me a job to do, then I must do the best job I can, according to the standards of my profession. From a medical person with medical ethics, in my opinion, that was not done by this panel of human health safety.
After Mr. Dodge appeared before this committee, there were other issues, other hormones, other antibiotics, and so on, that were raised in passing reference. On January 11, a general notice went out to our registry from Dr. Lachance listing 10 or 12 files with names. It states:
Please be advised that starting immediately, January 11, 1999, the following files cannot be obtained by anyone prior to my approval.
rBST; rPST; Revalor-H; Revalor-S; Synoflex; Components E-H; Components E-S; Components E-C; NDS Baytril; Baytril 100...
And the list goes on. There is quite a variety of drugs. Dr. Lachance then states that, "If anyone has any questions or concerns regarding this matter, please direct them to my office and I will address them as required."
We did not know the meaning of that. Someone in the media went after this and wanted to know the meaning of such an open letter. This notice was posted on the front door of the registry office. We could enter the registry office but any of these files were now forbidden. If we were working on any of those files, we had to go to Dr. Lachance to obtain them and justify our work.
We assume that a contract was written for the purposes of the investigation that Mr. Dodge had ordered, for he promised here that he would get to the bottom of it. He said that this is an extraordinary situation and he wanted to get into the depth of it. He promised that he would get back to you. He has done so, but here is the contract that was signed.
It is signed on behalf of Her Majesty by Dr. Paterson and the bureau representative, Dr. Lachance. You will note that both these gentlemen signed this contract on February 2, 1998. The person receiving the contract signs it on February 9, 1999. Something has gone amiss here. Either the contract has been sitting there for a year to be signed or it has been backdated. Dr. Lachance signed it on February 2, 1998, but he did not start work in the bureau until April 1, 1998. Therefore, he signed the contract before he took the job.
Mr. Dodge speaks about the PSSRB and the fact that the case was dismissed. He said that when there are differences, people can turn to the PSSRB for a fair judgment. That is exactly what we had hoped to do when we took the matter to the PSSRB. Unfortunately, the PSSRB chairman dismissed the case for lack of jurisdiction. He also said that there are serious problems that must addressed but that he does not have the authority under the Public Service Staff Relations Act to do anything with it. If we were removed or fired or some damage had been done to us, those were the only matters on which he could deal under the collective agreement. Nevertheless, the observation was made.
From this, Mr. Dodge tries to convey to you that the case was dismissed so that there was no substance in our grievances and complaints. That is wrong. I wish to mention that the entire information that was deposited before the PSSRB has been released not by us but by the PSSRB to the media. The media are the ones who are calling us for comments that we are not allowed to make.
The contract that I spoke about was obtained under Access to Information by David McKay of CBC Radio. The PSSRB documents were obtained by Mr. Bruno Bonamigo of Radio Canada/CBC Television.
These are the people who have sent me faxes of what they have obtained. They want our comments but we cannot comment because there is a gag order. We could be fired.
Dr. Lachance has now filed an affidavit in the Federal Court to defend his actions of placing the gag order and reprimand. The reprimand stated that I was not allowed to attend a meeting at 7:30 p.m. at the YMCA on genetically modified foods. In writing, his argument was that anything I would say there would not be on behalf of Health Canada. However, being a well-known member of Health Canada, I could be placed in the awkward position that my comments might be construed as such. I do not accept that I, as a citizen, cannot go to the YMCA and attend a meeting of public concern. The implication is that I cannot go to dinner at a friend's house and talk about my job and concerns. That is against the Charter of Rights, which covers me as a citizen of Canada.
In the affidavit, Dr. Lachance also said that he has always considered the rBST review to be a draft report. He may consider that to be a draft report, but Dr. Paterson called it the final report. That final report has now reached the FDA. It has been the subject of investigation by Secretary Shalala. It has been hailed throughout Europe. It is the only report, the key factor, which has finally broken the back of rBST on issues of human safety.
Dr. Lachance said that it was simply a draft report and directed us, in writing, to change the report. This is the report that was edited and not made fully available to the medical panel. The medical panel chose not to pursue the report further and chose not to talk to any of the authors. That is what we are examining here.
Mr. Dodge and Dr. Lachance, in another department, also talk about the qualifications of the people in Health Canada who supervise us. They claim that the authorities who are supervising us are also scientists. That is a patently false statement. There is not a single veterinarian in the department above us.
Dr. Lachance is a metallurgical chemist. Dr. Paterson is a chemist. Dr. Losos is a medical doctor and epidemiologist but he does not know anything about veterinary practice or veterinary medicine or issues concerning toxicology and residue management.
Dr. Losos did not answer your questions last time, Mr. Chairman, of whether he met with Dr. Chopra and whether Dr. Chopra is lying. By not answering, he left the impression that I was lying. It is to the contrary. I did not lie. I spoke under oath then and I consider myself to be under the same oath today. I am telling the truth.
Dr. Losos was sitting next door. He came out and met with us after we presented the final Gaps Analysis report. He did not discuss it then or afterwards. He may say that I did not approach him, but it was not my duty to approach him. He is the boss. He must call me. He has received my report. I do not have to pursue him. He must find out what was in the report. He did not do so, nor has anyone else spoken to us.
Mr. Dodge may be new in the department, but he has never bothered to find out from any one of us.
The president of PIPSC has been trying to meet with the minister. That meeting has not taken place. Our president has written to the Prime Minister. That letter has not been answered.
This is our terrible situation as Canadian public servants in the Department of Health looking after the health of Canadians who are eating food produced from animals that are receiving dangerous drugs, antibiotics and hormones.
In your documents we have put out a general sheet of the qualifications of people above us. Obviously, a minister is a politician could have any previous experience. He happens to be a lawyer from Justice Canada.
Mr. David Dodge comes from the Department of Finance. His professional qualifications are in economics.
Mr. Alan Nymark, Associate Deputy Minister, has a background in economics. He comes from Industry Canada.
Joel Weiner is the director general and he has no background in science, but has maybe a background in media. We are told he used to work at CJOH at one time. He is from Industry Canada.
Dr. Losos we have discussed. His background was in disease surveillance, not drug evaluation. He replaced the previous assistant deputy minister, who was a retired general from the army.
Ian Shugart appeared here. His background is in economics. He came from Industry Canada. This is the man in charge of our transition to the future.
Mr. Dan Michols has a background in art history and an MBA. He came from National Museums Canada. He is now the director general of therapeutic products. This is the man who wrote the national pharmaceutical strategy for Canada.
George Paterson, Ph.D. Chemistry, came from Agriculture Canada. He did not work at Health Canada.
Then there is Dr. Lachance, metallurgy, Agriculture and Agri-Food Canada, who replaced previous director Len Ritter, who also had no background in either drug evaluation or the practice of veterinary medicine.
Chief of Human Safety Division, Man Sen Yong, Ph.D. Pharmacology, is not a veterinarian. His background is in university teaching.
I spoke about Ian Shugart. Last year, there was a Canadian seminar organized by Health Canada on antibiotic resistance. This is an issue where the whole world is clamouring with fear. Antibiotic resistance is emerging from food-producing animals and affecting human health. People are dying when they go to hospitals because they pick up infections. It is coming from the sub-therapeutic use of antibiotics on the farms. This conference was opened by Mr. Shugart. His name here is shown as Dr. Shugart. I do not know why Dr. Losos, the real ADM, was not there but the visiting ADM, Dr. Shugart, opened this meeting.
We have here a newspaper report where the past-president of the Pharmaceutical Manufacturers' Association of Canada, Judy Erola, sat on the selection board of appointments of people at Health Canada. One of those directors is Mary Carmen-Kasparek who is now writing new regulations for herbal products. The department closed that area, but they are going back at it. Dr. Ritter was number two at that same selection board and then he was transferred. He was made the director of the Bureau of Veterinary Drugs after that.
I have discussed Dr. Scott. He retired with some kind of a settlement. Someone ought to look into that matter.
All of this, honourable senators, is worthy of the judicial inquiry that we have been asking for all the way through. When we asked for that, we were treated as political or bureaucratic lepers. "Just do not talk to these people. Isolate them. Do whatever you must."
Some of us are visible minorities. I will refer to a statement made by a former Assistant Deputy Minister of the Health Protection Branch, Dr. Liston. He is talking about all visible minorities, and he talked about me, because I was the one who was pursuing this matter of racism at Health Canada. He said that I do not make friends and that I could not be groomed into management, so therefore they would not let me apply for jobs. Then he talked in general about all visible minorities who lack certain soft skills such as communicating, influencing, and negotiating. Quite often, he said, cultural heritage has not emphasized these areas and they, meaning employees from different cultures, are at a disadvantage. We do business in the North American way -- the consensus-reaching model that to some cultures is very foreign. Because of cultural background, we need to communicate better or adopt a less authoritarian style. It is not a colour but a cultural problem. This is the assistant Deputy Minister of Health in writing. This is a court document, Mr. Chairman.
I am still before the tribunal. For 10 years, I have been fighting this issue in the department, and it still goes on. The tribunal hearings will commence on the 17th. Millions of dollars have been spent fighting me, at public expense, on this matter of racism and other issues within the department. I am not going anywhere. I am still there.
With that, Mr. Chairman, I will conclude our introduction. My colleagues will have more to add.
Dr. Margaret Haydon, Health Canada: Honourable senators, Dr. Chopra spoke briefly about the hormone Revalor-H. This was also a topic of discussion at the Public Service Staff Relations Board hearings last year. My particular concern is the safety of humans. This is one of the growth hormone implants that is administered to feedlot cattle.
This is probably the most extensive report on all the growth hormones that have been approved in Canada. For instance, in the three studies that I reviewed that came out of Europe, there is a very obvious and significant dose-related decrease in the thymus weight of young calves that were administered this hormone. It is a combination of estradiol and trenbolone acetate. They compared the untreated controls with a dosage of the combination hormone that was very similar to the one that has been approved in Canada and also in the various studies. The doses were increased sometimes as much as 10 times, and sometimes as much as 40 times. In the other two studies, the doses were increased to three and five times the Canadian dose. In all cases, in all three studies, the results were consistent. There was a very noticeable and obvious decrease in thymus weight.
My concern about this particular matter is that the thymus is very important in young animals and children in the maturation of the immune system. If this is being adversely affected, it is probably compromising their immune response and their ability to fight infection.
When I was reviewing this submission, both Dr. Chopra and Dr. Lambert were acting chiefs at that time, and I brought it to their attention. Of myself, one other evaluator and these two acting chiefs, none of us would recommend that this drug be approved. We were overruled, and it is now on the Canadian market.
Senator Spivak: Would you repeat the name of the drug?
Ms Haydon: It is Revelor-H.
Another effect that it produced in the female calves was a very noticeable increase in uterine weights. In addition to the increase in uterine weight, there was fluid found in the lumens of these uteruses. We are speaking about very young calves. They started the study at 120 kilograms of body weight. These are basically babies, if you want to compare them to the human equivalent. Therefore, there was actually an increase in glandular secretory tissue in the uteruses of these baby cows, in some cases up to three times the amount in the weight of the organ. Another term for this could be called precocious puberty.
There was also a decrease in the ovarian weight, and there was a proliferation of mammary tissue in the prepubative udders of these heifer calves. This is not normal and is not expected in very immature calves.
This has been a great concern of mine. It has fallen on deaf ears, and the department has gone ahead and approved this drug.
This drug has a counterpart, Revalor-S, which had been approved earlier for use in steer calves. These are the neutered male calves. One of the European studies also concerned some male calves. The very noticeable observation in that study is that there was an obvious reduction in the weight of the thymus. The prostate glands were tremendously enlarged.
Here again, we are talking about young calves. With the males, they started the study at 190 kilograms. They were not very large or very old. There was a significant increase in the prostate weight and also in the other secondary sex glands, the seminal vesicles. These were calves that had their testicles removed. They were neutered. Why did they have such tremendous increases in the secondary sex organs? This is absolutely not normal.
Those are my major observations and comments regarding this particular drug.
Mr. Gérard Lambert, Health Canada: Honourable senators, we heard that there is no human safety concern about the use of BST, but I think the problem is that the study that says that the BST is not absorbed was not properly reported. As well, there is another problem with IGF-1, in that the IGF-1 study was not reported properly.
Even though Health Canada has said that there is no concern with human health safety with the use of BST, if we look carefully at the original data as presented in 1990, some data showed that IGF-1 was absorbed in rats through oral administration.
IGF-1 has effects in animals. In that study, high doses resulted in some increase in body weight, liver weight and tibia length, which were all related to the absorption of IGF-1. However, they dismissed that effect because IGF-1 was not detected in the serum of those rats. The last time I gave testimony, on October 22, 1998, I mentioned that the methodology used to detect IGF-1 in the serum was not adequate, but that we can show some effects in that the increase of body weight demonstrates that IGF-1 is absorbed.
Last week, the human panel said that they do not report on that and until now, in the rBST file, there is no report that describes in totality the study that was submitted in 1990 that showed that IGF-1 was orally absorbed. It is because the review was not done properly and, even if we complain about it, until now there is no report on file that will describe that study properly.
The Deputy Chairman: I have a couple of comments and then we will go to questions from other committee members.
This may have something to do with your report. I have a letter in my files from the minister stating that there would be no repercussions for what you people did in going public. The other day, I believe Dr. Pollak said that you were heroes, and the committee members as well, for bringing this to the public's attention.
Have you experienced any reprimands, demotions or controls since the hearings began?
Mr. Chopra: Mr. Chairman, perhaps I can start. I have experienced two incidents. After I filed a court challenge on the gag order, on February 17, there was a report in The Toronto Star talking about the case. Some weeks later, Dr. Lachance called me on the carpet to provide an explanation. I received notice by registered letter that I should appear and that there would be someone from human resources present, and that I had the right to bring an observer or a representative.
I did go. I was told by Dr. Lachance that this was not a disciplinary hearing.
The Deputy Chairman: Did you have an observer with you, or a witness?
Mr. Chopra: I did: I brought someone from PIPS.
I was asked whether certain statements were accurate. The statements were that as a citizen I had the right to speak on matters concerning food safety, like any other citizen does. I was asked to confirm what I said, and I did.
I was asked about the second statement, which was that I felt I had an obligation to speak when the department did not do anything. Dr. Lachance asked me to explain that answer and whether it was accurate. I told him that it was accurate and that I had made that statement. Dr. Lachance then asked what I meant by saying that the department does not do anything. I pointed out to him that what was written is "when" the department does not do anything. There was a condition there.
I stated that I felt obliged to speak when the department does not do anything. I feel that I should be able to speak as a public servant. I did not say "I have an obligation," I did not say "I will be making a statement."
My representative asked why we were called there, that the meeting had probably cost the taxpayers $1,000, if you count up the hours. Dr. Lachance stated that I was his employee. I told him that I may be an employee of the department, but that he and I are in litigation in the Federal Court. I asked if he was going behind the court to intimidate me, and that I considered this to be harassment. That is one incident.
The next week, our union, PIPS, held a public forum on food safety, and you spoke there, Mr. Chairman. My colleagues and I were on the planning committee for that forum. Each one of us received a letter from Dr. Paterson, which had attached conflict of interest guidelines. We believe that some others who were also on the planning committee did not receive this letter. This was, again, a registered letter, stating that we may be in conflict by participating in such a forum. They mentioned certain items under which it could be considered a conflict.
I do not know what country we are living in. That ADM may have made that statement that visible minorities do not know how to conduct business in the North American way. I am a visible minority and I come from the most democratic country in the world, India. To me, freedom of expression is not only a right, but also a duty to each other. If I am making mischief, take action, but do not stop me.
Those are the types of things that are happening now. Was that letter intended to warn us away from the forum? Yet, at the forum, we wrote to the minister, inviting him to send someone to speak about the Food and Drugs Act. He designated Dr. Paterson. Dr. Paterson was worried about it, however, he is not coming; he is sending someone else. Dr. Paterson and the person who is coming, Dr. Dodge, came to see our coordinator, and the person who is coming made the statement, "I feel like a cow being led to the slaughterhouse."
This is the kind of professional talk that we hear from managers -- and they are calling us unprofessional. My colleagues also received the same letter. You have a copy.
The Deputy Chairman: Does any other witness wish to make a comment?
Ms Haydon: I would agree with Dr. Chopra.
The Deputy Chairman: Are you actually doing the work you are being paid to do in the department? Are you functioning?
Mr. Chopra: I think I function as well as or better than anyone else. There have been tonnes of briefings about me, and no one has ever told me my work is not right. My work is on time. No one has ever criticized it. You have seen some of my reports, writings and expressions. Yes, I am on top of things. There is no problem.
The Deputy Chairman: You mentioned that Dr. Lachance signed a contract in 1998 before he was an official employee of the department.
Mr. Chopra: That is right. On February 2, 1998, he signed this contract, but he joined the department on April 1, 1998.
The Deputy Chairman: Have any of your legal advisors been asked for a legal opinion on whether this is a legally binding contract?
Mr. Chopra: No, senator. That is a contract between them and the person who will do the job, an external evaluator. I am merely bringing it to your attention. When we are in court, no doubt many of these matters will be raised.
Senator Spivak: I should like to ask Dr. Haydon about the growth hormone. Obviously, this is a matter of controversy in the European Union and for all of the groups appearing before us. The issue is that everything must be based on sound science. There is a great deal of concern that some things are not based on that but rather on non-tariff barriers. Could you explain to us the scientific status of these reports related to the two growth hormones, Revalor-S and Revalor-H? Who manufactures them?
As well, could you tell us a little more about the process? You said that there were concerns that certain things in the process were overlooked. Can you tell us more about the length of the process and the questions that were raised?
Ms Haydon: I was assigned the Revalor-H review, which is the product recommended for use as an implant in feedlot heifers. Revalor-S had been approved a little earlier in the bureau.
When I was assigned the review of this submission in late 1996 or early 1997, we did not have a full-time chief in the Central Nervous System Division, of which I was a part before the amalgamation. This is why each of my colleagues here was an acting chief for four-month periods. They were in those positions while I was doing the review.
Hoechst is the company that manufactures this product.
The Deputy Chairman: Is that not one of the largest companies in the world?
Ms Haydon: It is a very large company, yes. Their representative had requested the director, Dr. Timothy Scott, to have an evaluator other than myself review this particular drug. They asked that the evaluator who reviewed Revalor-S should also be the one to review Revalor-H, which I had been assigned. That decision was not changed and I continued with the review.
In the initial submission, there were hints of the three studies that had been done in Europe, but there was not enough data. Therefore, I drafted an additional data letter requesting more information from this company, which was provided. More details of these reports were provided. They came out of Germany, France and the United Kingdom. Two were contract companies, I believe, that had done the research, and the one in Germany was a university. The animal numbers were extremely low, but in all three countries, the results were very consistent.
I brought these findings to the attention of both of my colleagues here because they were both from the Human Safety Division. I drafted a memo to Dr. Chopra advising him that I felt that these reports should be reviewed by the Human Safety Division because of concerns for public safety. I also made sure that I took a copy of that memo to the clerk in our business office, as well as the actual data submitted by the company. I asked to ensure that these were passed on to Dr. Yong, chief of the Human Safety Division. She assured me that that had been done. I did this because I felt so strongly about the impact on human safety.
Senator Spivak: In other words, all of these studies were studies that the company knew about or had done, or some of them were done by university and outside bodies. However, you did not do a literature search.
I am curious as to how this works. The companies supply the information. I know that Health Canada does not have the facilities to do its own research. Do you have sufficient time to do a literature search?
Ms Haydon: I have contacted the library many times to request information. I have been criticized by my chief for taking the time to do literature searches. I have also been criticized for writing too long a report, for providing too much detail, and for asking too many questions.
Senator Spivak: I understand that there is a standard operating package, which is not really under the Food and Drugs Act, but which is accepted when the approval of a drug is requested. We heard this with respect to rBST. It has to do with long-term toxicity and other factors that must be met in order for a drug to be approved. That is why I am asking you about the time. If that is accepted as a standard data package, then it must exist somewhere. If it does not exist, what happened to it?
I have two questions. First, is it accepted that there should be a standard data package under the Food and Drugs Act; second, what happens when you search and there are no studies, and all you have is what the manufacturer has given to you?
Ms Haydon: Yes, there is a package. Companies do have copies of these guidelines for preparing a new drug submission.
With respect to information, we are expected to review all the data that the company provides. If I have further questions or I do not feel the information is complete, I will request additional information. Sometimes published papers come to light that suggest that there are more concerns out there, and then I definitely have very good reason to ask for more information from the company.
Senator Spivak: Would you say that the reductions in the research that is available within the department have hampered work that relates to filling in the gaps? There have been severe cutbacks. Do you think you would need more assistance?
Mr. Chopra: Senator, perhaps I could assist. Under the Food and Drugs Act, when a submission comes in, a standard package is required and the company is expected to submit all the research it has done. This is the process in Canada. In the United States, they do their own research. Canada is too small a country to venture into that kind of thing. Therefore, we accept data from recognized countries anywhere in the world, such as Europe, Britain, and the United States. We review the standard data package. We may do our own searches, but that is not the requirement. The company is supposed to produce the research data, and then, based on that, we either say "yes" or "no" or we put conditions and restrictions on or ask for more data.
The second part of the question dealt with the time that it took. In this particular case, Dr. Haydon had just started the review. We, her temporary supervisors, were told, "Do not give it to her. She takes too long and she is too nitpicking," which is the actual word used by the company representative. Then I was told that if it were not done quickly enough, he would complain to my boss. Those kinds of exchanges were taking place. They even suggested that I was preventing Dr. Haydon from speaking to him. This is not true. He was just harassing her constantly.
Once the review is started, we have four months to complete it. That is the statutory time. Dr. Landry was pressuring me to hurry up. He took partially finished reports and was constantly calling the company, telling them what was happening.
In the end, he overruled four of us, four different scientists, totally unrelated, who reviewed the drug. Then he writes this. Paterson, even though he was the acting director, said in writing that Dr. Landry would make the final decision. When Dr. Landry made the final decision, he sent an e-mail to Dr. Paterson saying, "I have cleared the drug. The company is happy." You know that part of the story; it has been told before. You can see what is happening here when we talk about pressure on us.
Senator Spivak: You are only confirming my anxieties about the evaluation of company-sponsored research, which I think is the key point.
The other question I want to ask you has to do with sound science. Sound science to one person is a non-tariff barrier to another person. This is a tricky issue.
In the case of these two growth hormones, would you say that what you looked at would stand up as sound science? This is what is going on in Europe at the moment.
Mr. Chopra: An article came out two days ago. Dr. Haydon was talking about sound science concerns. We are the auditors of science; we only look at what we receive. We have been told that hormones in beef are no problem, that they do not cause anything. Estradiol has now been admitted, even by the United States, to cause cancer. This is the hormone that was in Revalor-H. This is the hormone which is in other beef-producing drugs. This is the issue that we had in front of us, and we were told, "You are not to talk about it. This is not science. The Europeans are not scientists." We were kept out. Who goes on the JECFA panel? Dr. Ritter was saying that there was no problem and so on. You will get into that later on. However, yes, this is what we do, and we were told that we cannot do it.
The Deputy Chairman: I will remind the committee that someone on the committee asked Dr. MacLeod whether he read all the data that he was given. He said no, because there were thousands of presentations. He made his decision without a thorough study, also.
Mr. Lambert: The external human safety panel did not review the data submitted by Monsanto because there is no report to that effect. They just reviewed what was in the literature. Dr. MacLeod said, when he was last here, that he is not interested in that because it is history. However, that human safety package was the basis for the FDA report that approved rBST, and the JECFA report too.
Those studies were never reviewed properly in Canada. Up to now, there is no report on file on that. At that time, there was an undergraduate co-op student in the bureau who worked on that file and prepared a report. When I asked for that report, I was told by my chief that it was confidential information.
The Deputy Chairman: Is that the report that was done in Guelph?
Mr. Lambert: No. It was a report done on rBST from the Bureau of Veterinary Drugs. It was done by an undergraduate student. However, up to now, there is no report on file to examine. It was considered confidential information.
Mr. Chopra: Dr. Lambert forgot to add one thing concerning Dr. MacLeod's committee. He said that he looked at or received information from many sources. The actual data package submitted by Monsanto, the package that was in the department and that had all of that information, was still in Dr. Lambert's custody while we were reviewing it, and it had not been delivered back. It stayed with him until October. Dr. MacLeod did not look at any data. We do not know what data he received.
Mr. Lambert: I was asked for a copy of the data after October 27, last year. I told the committee that I still have the original data from Monsanto. At that time, Dr. Ian Alexander asked me for the reports, and he made copies. However, until that time, I had it. It was not provided to the human safety panel.
The Deputy Chairman: Dr. Haydon, with regard to your findings about the growth-promoting hormone for beef, do you think the European Community was right in saying no to Canadian beef that has that hormone?
Ms Haydon: I think pretty well all of the beef in Canada is implanted during the growing process. I do not know what the hormone levels would be but it is definitely used in Canadian beef. Does that answer your question?
Senator Kinsella: Could the witnesses share with us whether or not there exists, either nationally or internationally, an association or grouping of drug evaluators?
Mr. Chopra: There is no such thing. Every country has its own evaluators. There is a sort of collegial body called the "Codex Alimentarius of the United Nations," but their decisions are not binding on any country.
Senator Kinsella: Is there a network among the evaluator community around the world? Do you and your colleagues talk to each other in terms of the processes associated with evaluation?
Mr. Chopra: This is an excellent question. It is a big problem. It could and it should happen, but it does not happen. It is not allowed to happen because the managers decide to whom we will talk, what meetings we will attend, what scientific conferences we will attend, what papers we can write and where we can write them, and whether we can speak, or whatever. There is complete control over the system under the term "confidentiality of proprietary rights."
We have been in situations where a company says, "We have submitted this material to the FDA. You can either get it from them or get a freedom of information summary." We get the summary and ask for the same data. The company tells us to get it from them but headquarters says that it is not allowed. This concerns documented materials within the department.
Senator Kinsella: What is the underground communication network saying in your profession around the world about the situation in Canada?
Mr. Chopra: It is not so much underground. Actually, it is fairly above-ground because we are now living in the day of the Internet. When litigation occurs, it is available as public information. When things happen at the WTO, you read about it in the newspapers and hear about it on the radio and television on a daily basis. We can also receive copies of committees such as yours. We have a report on beef hormones on the House of Commons Committee on Agriculture and Agri-food. All these questions were extensively discussed by the Commons committee. However, none of us was present there. Dr. Yong was present there, but only as an advisor. The people who were making presentations from Foreign Affairs, Justice Canada, Industry Canada, and so on, were all economists. In one place, a question is asked of Dr. Yong about rBST. Although the issue is about hormones, the parliamentarians were saying, "We are talking about beef hormones. What about rBST?" Dr. Yong had the audacity to say, "We are still looking at it." That was in February 1998, when, in 1990, he had said in writing, "There is no problem." The department has been taking that position.
We do get that information, but we do not know what to do with it -- that is, unless hearings like this take place where scientists are forced to speak under great threat. This one would not have occurred either -- that is, unless we were willing to risk our own careers at our own initiative. You would not have known about us. We could have been fired. Many people have been. Whole departments and areas have been closed down. You would not know about it. It comes under "normal cuts" and "budgetary planning" and so on. Science is thoroughly compromised. We do not care if Canada does not do any science, but science that is concerned with public safety cannot be jeopardized. No one should allow that to happen to our country, to our people and to the people who produce those products. Our farming communities are in equal danger.
Senator Kinsella: Dr. Chopra, this committee has been conducting hearings for a period of time now on this topic. I take it that you and your colleagues have read much of the testimony that has been adduced before this committee. In your reading of the testimony that we have heard in this committee, is there much testimony in your opinion that is untruthful, inaccurate, misleading or false?
Mr. Chopra: These were our materials from which we spoke. It is 53 pages in length. This is a summary of what we wanted to talk about. We thank you for your indulgence, but we will leave with you half a truckload of paperwork. If this is a question of credibility, we do not just come here to speak to you. We will give you documentation that you can submit wherever you want to whomever you want for your own research and evaluation. This is already available; we just assembled it from publicly available information.
At this point, we plan to bring other materials to the attention of the president of our union, who appeared here this morning. We will ask him to take these things up directly with the minister but not with the deputy minister. That is the political truth. In this country, all other routes have failed. The bureaucratic system has not worked. They say, "There is no problem. You are just making it up." We have gone to the courts and they say that we do not have jurisdiction. You are the only committee that has asked us to testify, under great stress to us. Those threats have occurred in spite of the minister's assurance to Senator Whelan that it will not happen. It is happening. Some senators said, "If anything happens to you, come back to us in five years." It is not five years. It is just a few weeks or months and we are here again. Those materials will be sent to the minister. That is the political route. We will let him deal with the situation. You will have access to them through the political route.
Senator Kinsella: In your testimony this morning, you told the honourable senators that at one point you were called by someone who said that he did not want Dr. Haydon to be the evaluator because she was a nitpicker. Who called you and said that?
Mr. Chopra: It was a man from the company.
Senator Kinsella: From the company that was seeking the approval of the drug?
Mr. Chopra: Yes. The matter did not finish there; it continued when the drug was cleared. I do not know if you are aware, but this story has come out before. When Dr. Landry cleared the drug, he sent an e-mail to Dr. Paterson, the Acting Director, saying, "I have cleared the drug. The company is happy and I have told them that I would make up for the rough treatment received from the evaluators." Dr. Paterson replied to that same memo, "I hope you did not promise him the moon, though."
The things that I am talking about have been confirmed by the PSSRB. Under oath, Dr. Paterson has admitted that what I said there was essentially accurate. Those are his words.
Senator Kinsella: In my academic field, nitpicking is considered to be a virtue, not a vice. In the area of your science, namely, evaluating drugs to determine that they are safe so that the Government of Canada will certify such and allow a drug to be circulating and used, is nitpicking by that scientist considered a virtue or a vice?
Mr. Chopra: We are paid to nitpick for the sake of human health. That is my job.
Senator Kinsella: This morning Dr. Chopra made reference to a letter he received from an assistant deputy minister in which issues of ethnoculturalism were mentioned.
Some of us on this committee are interested in valuing Canadian diversity. We are interested in issues of egalitarian human rights in our country. We would be interested in having a copy of that letter. Could you table it with the committee?
Mr. Chopra: Yes. This is a landmark case. It is called The National Capital Alliance on Race Relations and the Canadian Human Rights Commission versus Her Majesty the Queen, as represented by Health and Welfare Canada, the Public Service Commission and the Treasury Board of Canada. Three departments were jointly indicted. I was president of the National Capital Alliance on Race Relations at the time.
Senator Kinsella: Is that from a decision of the human rights tribunal?
Mr. Chopra: Yes. It was subsequently filed in the Federal Court.
Senator Kinsella: Was the respondent the Department of Health?
Mr. Chopra: The Department of Health, Treasury Board and the Public Service Commission. The tribunal found that there was a violation of human rights.
Since we won this case -- and the Canadian government and U.S. politicians should be interested in knowing this -- the Canadian Human Rights Act has been revised so that no such similar complaints can be filed again.
Senator Kinsella: They will be rewriting the whole act now.
Mr. Chopra: It is terrible what is happening to our country.
The Deputy Chairman: I do not know how many of you read or heard the speech given by the President of the Czech Republic when he was hear last Thursday. He made a speech to a joint session of the Senate and the House of Commons. Everyone should read that speech. He stressed human rights and the individual. It was one of the best presentations I ever heard in describing what our rights should be.
Dr. Chopra, when you are talking about rights, you are looking at a minority up here. In agriculture, we are rapidly becoming the smallest group in Canada. There was an article in The Ottawa Citizen about dairy farmers, a group for which we fought so hard. You would almost think we were the villains. We built the best dairy industry in the world.
They still have the philosophy that we should be selling our product like we did in the medieval days.
[Translation]
Senator Robichaud: Dr. Lambert, you talked about IGF-1. This was also raised in the report of the expert panel of the Royal College of Physicians. In two of their recommendations, they said that there is a need for further studies on the reaction to IGF-1 or its absorption. You also mentioned a report written by a student. Have there been any further studies made? Should we recommend specific studies on this aspect?
This concerns me. The scientific community seems to show an interest and eventually we might find out more about the role of this substance. Should we order further studies right away in order to find out more and get a clear picture?
Mr. Lambert: There were data in the package submitted by Monsanto in 1990 that showed that IGF-1 was absorbed orally. This observation has been put aside and has been continually denied. But in this report it was shown that there was absorption through the oral route. This has been confirmed by later studies and in 1990 it was determined that IGF-1 in its pure state was indeed absorbed orally. It has also been shown that IGF-1 associated with casein, which is a milk protein, is absorbed much more readily, at a rate up to 67% greater. It is wrong to say that we have no knowledge about this at this time. It is clearly shown in this study.
Senator Robichaud: You say it is proven that there is absorption, but do we know what the effects are?
Mr. Lambert: Yes, there was an increase in body weight, in the weight of the liver and the length of the tibia. This study has been set aside and they said there was no absorption. There have been no further studies on IGF-1, except one lasting two weeks. Since the results were positive, this should have led the company to prolong the trials for at least 90 days. But its goal was simply to find a dosage where there was an effect. It was not a definitive study.
When we do studies on other animal species, for example dogs, we find it can be absorbed. This indicates a need to look into teratogenesis and the effects on reproduction. These studies were not done because these data have been set aside.
Senator Robichaud: Who set them aside?
Mr. Lambert: The evaluators who worked on the product.
Senator Robichaud: Did they work for the company who manufactures the product or for the expert panel?
Mr. Lambert: These observations were noted in an article in Science magazine in 1990. It was said that this was not an effect of the drug. However, this had been observed in groups treated with sub-cutaneous injections, where the results were positive. They denied the evidence and they got away with it. In Canada, this study has never been adequately reviewed.
It was not part of our mandate to do this review and to evaluate the original data submitted by the company. They didn't give us time to do so. These data have been ignored by the FDA Committee and the JECFA.
Senator Robichaud: Are you telling me there are reports linking IGF-1 and the growth hormone and that suggest further studies because the results are not sufficiently clear? Or are they sufficiently clear to establish a link?
Mr. Lambert: Those who made the decisions said there was no absorption at all but the studies show there is absorption. There should be further experiments to confirm and find at which dose there is no effect.
Since it was demonstrated last week that the amount of IGF-1 is not important in a trial because there is absorption, this is a very significant effect. To say that we did not know in 1990 that IGF-1 can be absorbed orally is completely false. The company demonstrated in a two-week study that there was an effect linked to IGF-1. But we did not have access to these files.
When we asked for these reports, they were not in the central file of the company. They were not put on file before 1997. Even at the end of May 1997, this report was not accessible to us because these data were considered confidential even within the Bureau of Veterinary Drugs.
Senator Robichaud: Is it a fact that the expert panel of the Royal College of Physicians, when it wrote its report, did not have this information because it wasn't included in the whole package of data that was submitted about this hormone?
Mr. Lambert: No, Senator Robichaud. At the beginning, they did not have these data because they were under lock in my office. They were not transmitted to the expert panel of the Royal College. It was only after my testimony that Dr. Alexander asked me for the reports to make copies. He had met with the company after our testimony on October 23, and this is when the company decided that the expert panel should have these data so that it couldn't be accused of hiding information. It was the company who forced Health Canada to provide a copy of these data to the expert panel. They did not have them at the beginning, just as we did not have them when we started our review to look at the gaps in the evaluation of BST. We were not supposed to review these data. But when we looked at them we found that some of the reports on BST had been suppressed and were not even mentioned, such as the report of the European Community. Even the latest report of JECFA says that there is no absorption of BST, the bovine growth hormone, and of IGF-1. Even in 1998, they were still saying that there is no absorption, that the substance is digested by intestinal enzymes and that there is no effect.
Already in 1990, further studies should have been undertaken because BST is used in dairy cows and people drink milk all their lives. There should have been studies looking for chronic effects, just for reassurance. Since the company says there is no absorption, it shouldn't be afraid of undertaking long-term trials. However, if these studies aren't done, we can be sure that no effects will be found. We do studies because we want proof. It may be an inconvenience, but at least we can be assured of not putting out on the market products that become toxic after long-term use.
Dr. Pollack stated last week that it is not normal to request studies to look into the effects of IGF-1 on humans. You cannot conduct such studies of veterinary products because humans cannot be exposed to them. The product needs to be approved before the population is exposed. If the product is not approved, the problem cannot arise and no effect on humans can be demonstrated.
Senator Robichaud: I do not quite follow you.
Mr. Lambert: These were requests for studies. Dr. Pollack mentioned that he would like to have epidemiological studies to demonstrate whether there are problems after 15 years of use. But in the case of veterinary products, instead of using humans in the trials, we use laboratory animals over their lifetime. We ask for chronical studies in order to protect people from toxic products. In this way we can determine if humans are protected.
Senator Robichaud: Which we cannot say for sure at this time?
Mr. Lambert: No.
[English]
Senator Spivak: I understand that one of the reasons that the external panel said that there was no problem with IGF-1 is because they said that even if it were absorbed, that there is a greater amount of IGF-1 in mother's milk.
Am I correct that it is not rBST that is harmful, it is the product IGF-1? Therefore, there is a correlation between increased levels of IGF-1 and increased levels of breast and prostate cancer. Could you clarify that for me?
Mr. Lambert: IGF-1 is the same product and has the same chemical composition in all species. It reacts in exactly the same way. However, the quantity and the level of exposure over time of IGF-1 in mother's milk is not long, compared to the rest of one's life.
The Deputy Chairman: Could you tell me what the acronym IGF-1 represents?
Mr. Chopra: IGF-1 stands for insulin-like growth factor. Scientists do not know how to describe it better than that. It behaves like insulin. In other words, any time there is any kind of growth in the body, this factor appears.
IGF-1 can occur at any time, anywhere in the body. As an example, the level of IGF-1 increases when a mucous membrane is present, during mammary development or during uterine development. It is just a factor. There are other factors involved as well when there is an indication of growth in the body.
One must remember that the amount of IGF-1 is not as critical as the duration of its presence. In addition, there may be other subtle, unknown differences. Dr. von Meyer said the other day that what you need is the appropriately inclined cell which is cancerous to which IGF-1 might attach. Once it attaches, that cancerous cell goes on to cause cancer.
Our body contains cancer cells all the time. Every mole on our body is a potential cancer that has been inhibited because our body responded and controls it. However, if you continue to stimulate it by sitting in the sun or putting chemicals in your food, or whatever, then those cells can be stimulated.
These are unknown areas that we cannot know about for another 15 to 20 years. This is what Dr. Pollak's point was. My point was if that if that is the amount of time we need to determine it, we should be taking precautions not to say it is safe.
Senator Spivak: It is important to remember that these are non-therapeutic drugs.
Mr. Chopra: That is correct, yes.
Senator Spivak: Non-therapeutic drugs are there for commercial reasons. We are not talking about cancer prevention.
The Deputy Chairman: We are running way behind time. Who should the committee contact in order to follow up when we read your presentation to address any inquiries for clarification? Should we go to you, Dr. Chopra, or to whom?
Mr. Chopra: Mr. Chairman, you can address any one of us because we work in concert. We reviewed this subject with each other in preparation for the meeting with your today. Although I spoke the longest, that is probably in deference to my age, as opposed to my intelligence. However, whichever one of us you approach, you will receive a consolidated opinion.
The Deputy Chairman: I am still concerned about this gag order that you are operating under. I find that incomprehensible. It is difficult for me to understand that this kind of situation exists in Canada.
Senator Kinsella: Mr. Chairman, I find it quite disturbing that a parliamentary committee, particularly a committee of the Senate, would hear about things like retaliation being taken against witnesses who appear before this committee.
Therefore, I should like to request and, if necessary, make a motion, that the clerk of this committee be instructed to prepare a paper outlining the anti-retaliation measures that can be taken by this committee or any committee of the Senate, should a committee witness be subjected to retaliation by any person or persons for having testified before the Senate committee. I would also suggest that the clerk look into the principle of the extension of parliamentary privilege.
By way of a footnote, I would refer the clerk to an excellent paper that has been written on privilege before committees of the Senate of Australia.
The Deputy Chairman: Is there any further discussion on Senator Kinsella's motion?
Senator Spivak: Mr. Chairman, I am glad that Senator Kinsella is here today. I agree that we need to review the process that we are undertaking to ensure that none of the witnesses that we ask for information are subjected to retaliation. We have the Minister of Health's word on that. We should also ensure that that message is conveyed to the lower levels of management.
The Deputy Chairman: I am as concerned as Senator Kinsella. From reading the documentation and letters presented here, Health Canada officials seem to think no one should question what they are doing. That is not the way we built our country. That is not the way we want our country to be.
When Dr. Pollak appeared before this committee, he suggested that this committee and perhaps the Senate could give leadership to try to promote an international body that would address issues such as these.
I wish to thank you for your presentation. Dr. Mueller, I have not heard a word from you, so you must be agreement with everything.
Dr. Thea Mueller, Health Canada: Yes, I agree with what has been said.
I would point out that when we were discussing IGF-1 levels, I would return to my original comments. We need to return to basics and determine what the actual exposure levels were. Were the methods that they used to calculate them validated?
Also, what margin of safety do we have with these exposure levels? These are now determined on a smaller proportion, perhaps 20 per cent of the treated herd. What would happen if 100 per cent of the cows were treated? How high would those IGF-1 levels go, and what health hazards would they present at that point? We always must look towards the future, as well.
The Deputy Chairman: I thank you all for attending.
Senator Spivak: Should we vote on Senator Kinsella's motion?
The Deputy Chairman: Is anyone opposed? It is agreed. Thank you.
Our next panel is ready. Please proceed.
Ms Angela Rickman, Deputy Director, Sierra Club of Canada: I thank the Standing Senate Committee on Agriculture and Forestry for the opportunity to address some of the concerns of the Sierra Club of Canada regarding the registration of products of biotechnology in Canada.
I would like to congratulate the committee for its excellent work to date on this issue, particularly surrounding the registration or lack thereof of rBST in Canada. I would further like to commend the committee for its ongoing commitment to thoroughly review this issue.
I want today to outline some of the issues of ongoing concern to the Sierra Club and other like-minded organizations. Biotechnology has been introduced into a world where public policy is ill-equipped to deal with its implications. Senators have studied the governmental handling of BGH and other growth hormones approved over the objections of scientists who testified before this committee. Perhaps you have drawn the conclusion that this process demonstrates the inadequacy of government mechanisms to control the technology.
This is a time of rigorous analysis of costs and benefits in human health and environmental risks of this radically different type of modification of life forms. Yet government institutions have moved in the direction of less regulation and greater deference to the industry.
The ominous words of the Health Canada manager who told Shiv Chopra that the client is industry, need to be seen in a context where, in the largest sense, serving industry is seen as the raison d'être of government.
The WTO beef hormone challenge needs to be understood by Canadians. Canada challenged the right of other sovereign nations to ban the importation of a genetically modified form of beef. Canada argued against the precautionary principle, although our government did not share their arguments with Canadians generally nor did they allow input into that argument.
The WTO decision therefore, by inference, makes it clear that this is what Canada did. Canada argued that the general exemption for measures designed to protect health or natural resources could only be ruled GATT-acceptable if such measures were necessary to protect health. Mere concern or exercise of the precautionary principle, therefore, is not an acceptable reason to keep out chemicals or food additives or whatever. The evidence for risk of harm must be universally accepted to justify a ban.
In light of recent experiences, ranging from the case of rBST, the safety of the blood supply, British beef and mad cow disease, it is clear that the early voices of caution are discounted. The momentum is in favour of introduction of new commercial products, and the voices with the greatest influence are those who stand to profit. There is little consideration of whether there is an actual benefit to consumers of the product. It is primarily industry driven.
The decline of the ability of national governments to ban potentially dangerous products is significant and largely ignored. In Ottawa, over the course of the last week, an obscure or once obscure body called the Codex Alimenatarius held meetings. On the agenda were the issue of labelling biotech foods, and rBST, had it been approved, would have qualified there. This body is rising in importance as a major force for weaker standards if forced at a global level. While most Canadians have never heard of Codex Alimenatarius, it is likely to have a more decisive role in setting safety standards, including pesticide residues, than the Canadian government.
Originally designed to help developing countries set standards for food safety and quality, Codex Alimenatarius was created as a joint commission of two United Nations agencies, the FAO, Food and Agriculture Organization, and the World Health Organization. For years, Codex Alimenatarius enjoyed virtual anonymity. Its role was minor, and consumer, health and environmental groups concentrated on getting strong standards domestically. Transnational corporations saw the opportunity to create one set of harmonized global standards with few noticing their dominant role in the process. The women's environment and development organization brought corporate involvement in the Codex to light, however.
By the 1991 Codex meeting, there are more representatives of giant TNCs than from government -- 140 from corporations and only 105 from government. Coca-Cola alone sent 18, so concerned were they with food safety. Unilever sent nine representatives, and Monsanto sent eight. While Codex was initially supposed to concentrate on food safety standards for the developing world, industrialized countries quickly dominated the process with TNCs and their delegations. At the 1993 meeting, Coca-Cola had the largest delegation, followed by Nestle. In fact, 48 countries had fewer representatives than Coca-Cola and Nestle, including wealthy industrialized countries like Switzerland, the UK, and Australia.
At the Codex meetings in June of 1997, Codex Alimenatarius met in Geneva to review, among other things, the possible acceptable daily intake and maximum residue levels for bovine growth hormone. The Codex decided to further study the new scientific and health information linking BGH to cancer of the prostate, breast and colon. It is disturbing that Canada voted against further study of BGH or rBST, as Monsanto the manufacturer prefers it to be called. At the Codex meeting, Canada was prepared to set a standard that imposed no limit on BGH in milk. Further, Canada voted against considering any other legitimate factors in setting a standard, including factors such as consumer resistance. Canada's vote becomes even more disturbing in view of the delegation. It included Monsanto, the manufacturer of the product, but no environmental, health or consumers groups. The man who is listed on the delegation list as chair, Standing Committee on Biotechnology, Canadian Agri-food Research Council, is actually Monsanto's director of government regulatory affairs and is also a registered lobbyist for Monsanto. Internationally, Canada's recorded vote speaks for itself. Canada is essentially there when Monsanto and other transnational corporations call.
Increasingly, Codex's role is become being crucial for setting all food standards globally because it has now been recognized in a number of rulings at the WTO not as the minimum acceptable level for food standards but as the maximum. The use of Codex as a ceiling instead of floor has been set out, for example, in the decision that struck down the European ban on the importation of hormone-treated beef as contrary to the General Agreement on Tariffs and Trade. Laws and regulations to keep dangerous pesticides and other organisms out of our shopping carts have already been treated as a trade irritant under NAFTA, and Canadian maximum residue levels for certain pesticides have already been raised to conform to U.S. laws. Any of our food safety laws can be trade challenged. When deciding how safe is safe enough, the Codex standards will be the toughest allowed. Thanks to the beef hormone ruling of the WTO, Codex, originally created in the 1960s, actually can override well-researched and considered decisions of industrialized countries.
To see how this occurred, we need to review what happened when Canada brought the complaint to the WTO about the European community's ban on hormone-treated beef. I would stress that the Senate committee should make its recommendations bold enough to identify the problems of the current system and recommend that Canada on principle not resort to WTO challenges, as we have on asbestos and beef hormones, against the interest of the health of other nations. We should renegotiate WTO agreements to provide firewalls against trade-logic-contaminated public health and safety regulations.
Labelling of GM food is essential, but we should revisit the implicit assumption that if Monsanto made it, it must be good for us. In a democracy, the public has the right to determine which technologies are used in their communities and, similarly, which drugs. We do not want the safety of our food determined by large, unaccountable multinationals like Coca-Cola and Monsanto. We do not want Canada arguing against the precautionary principle in setting food standards and WTO challenges.
Mr. Victor Daniel, Co-Chairman, Toronto Food Policy Council: Thank you, Mr. Chairman and senators, for the opportunity to make a presentation again today, as we did back in December.
On January 14, 1999, Health Canada announced that rBGH would not be allowed for use in Canada at the present time due to information presented by the expert panel on animal safety, not human safety. I come here today to address the deficiencies we have found within that report and how it affects us in Ontario, specifically the boards of health under rights and obligations under the Health Protection Promotion Act of Ontario.
We concur with the decision of Health Canada but not with the entire rationale. We are quite adamant that the following deficiencies regarding the expert panel on human safety be addressed and rectified; otherwise, we know our regulatory process is defective.
First, Health Canada has incorrectly named the human safety panel as that of the Royal College of Physicians and Surgeons of Canada. We have the rBST backgrounds notes from that College of Physicians, and they have stated that committee is not of their making. It is in the back of our report. I contacted Dr. Stuart MacLeod and, in a letter to our counsel, he told us that his mandate did not extend to examination of milk as a product as defined within the Food and Drugs Act regulations. He did inform us that they were mandated to create human exposure models regarding IGF-1 where justified by data. Unfortunately, there is no data that is quantitative or objective regarding this matter as of yet. Therefore, in that human safety report, no models were set up.
It is essential that people understand we are going about this in a backwards fashion. I concur with the testimony this morning of Dr. Thea Mueller. We must deal with how many cows are being injected with this drug because each cow will create an individual elevation of IGF-1. Therefore, the first basis is the dairy herd. Who has the right to drink milk from that? By Canadian law, the dairy farmers can drink their own milk. How many cows of a 40-cow herd? Two, twelve, thirty-two? Each one creates a scientifically different point of structure to assess. The second model that should have been expressed was a consumer population purchasing milk from a single processor who was getting milk from an area of high rBGH usage. The third, then, would have been the general population at large. Having identified that, we then identify the vulnerable sections within each of those models, whether it is children with ADD, diabetics, or cancer patients. There is a lot of work in toxicology review.
To be fair to the human safety panel, that would have been their difficulty. Because we have not done that, we do not know what IGF-1 levels we would be exposed to. Scientifically, we would be giving the farmers the drug that creates a scientific effect for which they have no scientific use. The non-therapeutic use of the drug does not give them a rationale. Today I may use it on half my herd, next month perhaps just 10 per cent, and next year I will not bother. It is all over the place, and you have created an uncontrollable situation. Without controls, there is no protocol to manage an assertion or a point of scientific fact.
The other point that we get into is that the human expert panel chose to ignore establishing purity of the drug in question. In order to do that, you should have seen some readings on high performance like chromatography, which would have proved that the research drug had the same profile as the marketed drug and that there were no impurities or contamination of the drug as a result of processing.
I believe Dr. von Meyer may have brought that up last Monday.
The human safety panel misquoted a reference by stating that dairy cattle injected with the recommended dose of rBGH, do not increase the content of bovine growth hormone measured as natural plus recombinant bovine growth hormone as combined. Table 3 in that reference, which we have listed below, shows a 30 per cent increase. How do I accommodate the discrepancy?
The point is not scientifically valid in the first place because the target animals have their own natural bovine growth hormone levels. They are using the old standard of treated group versus a control group. Scientifically they have already admitted that cattle have varying levels, therefore, they should actually have focused on establishing the target animals to be used, taken a reading of their own growth hormone levels, injected them with the drug and then reread the readings on those cattle to get a truer reading.
The most important thing for us is that the Groenewegen paper, which they have quoted, uses incompatible pasteurization temperatures for human exposure. The milk samples are overcooked in this study and are not valid for human consideration of safety.
The Deputy Chairman: May I interject? Perhaps you should explain how long you cook milk for normal pasteurization and how long they cooked it?
Mr. Daniel: I will deal with the pasteurization shortly.
Most important, the drug that was used in that study is not Monsanto's, that is Cyanamid's, and it has a completely different amino acid profile than Monsanto's, therefore, it is different by nature. We also quote literature in our paper which states that even the addition of one extra amino acid can create extra half life on the effect of a drug or a hormone poly peptide.
The human safety panel also quotes two references of proof that pasteurization of raw milk is destroyed during pasteurization of BGH. One of those references is the one I just mentioned using the wrong one, and the other is an abstract I have not yet received. Pasteurization has many different levels under the Food and Drug Act. The processors have submitted the formula, which it is in the back of my report. For human exposure the correct temperature is 161 degrees Fahrenheit for 16 seconds. The research used was 173 degrees.
We also must deal with the fact of two false impressions that the panel left regarding insulin-like growth factor 1. The first is that 90 per cent of insulin-like growth factor 1 is destroyed by infant formula pasteurization. This is another point we will get into. That is technically correct, however, infant formula pasteurization is 250 degrees Fahrenheit for 20 minutes. Therefore, our point is: What use is that for human exposure when people are drinking fluid milk at 161 degrees Fahrenheit for 16 seconds? The tables are here.
The second impropriety is the claim that levels of IGF-1 in human breast milk are higher than that in rBGH modified dairy cows. Again, that is technically correct, however, it is not relevant for human safety. The exposure time of human milk IGF-1 levels is normal for infants nursing for a period of three months to a year of age. This is not a scientifically valid comparison to those people who are being exposed to elevated levels of insulin-like growth factor 1 in milk being protected by casein in bovine milk for up to 50 years of consumption. We are past nursing. We are dealing with a whole new exposure level.
The entire matter of the human safety panel from our perspective is that it is subjective, not objective. The inclusion of the 1998 Joint Expert Committee on Food Additives Summary and the conclusions on somatotropin by the human safety panel is unacceptable. By point of order, that document states that no one is to quote that summary until the release of the World Health Organization Food Additives Series 41, which is now released. Also, required reading is the Food Agricultural Organization Food and Nutrition Paper Series 41/11, which was not published at the time that committee met or printed its report. It is not even yet published at all.
I have talked to Dr. Herrman in Switzerland, who is the secretary of the joint expert committee, and he assured me that they hope to have it done by mid-June. However, just for the Senate's note, 41/11 has been recoded. It will now be called Technical Series Report No. 88, according to Dr. Herrman.
Regarding JECFA, I wish the committee to note that JECFA reports have a disclaimer on them, and I quote:
This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization or the Food Agricultural Organization of the United Nations.
Therefore, our council does not recognize JECFA in this matter because we are bound, as are our board of health and other health units under Ontario regulations to the following points: One, that milk is already within the definitions of the Health Protection Promotion Act of Ontario, as are the pasteurization temperatures, which are listed in the back of my paper, and I have included two of the act's responsibilities as well.
I would also remind you that under this act you must legally prove pasteurization has occurred. The research studies permitted by the researchers and by the human safety panel on Health Canada have included research on pasteurization that did not prove it even happened. You must prove through an official test, called the alkaline phosphatase test, and you must administer that to prove that pasteurization has been accomplished.
We also quote literature in the footnotes here of dairy journal sciences that do prove the point, even though milk sample for human safety is not the consideration.
Proof of pasteurization has been required since 1898, since Denmark had to deal with tuberculosis in cattle. They had an argument back then that was rather neat. How do you prove that pasteurization has occurred? How will you make us buy pasteurized milk? What is the difference? You cannot tell the difference. Have you heard that argument before? They had that argument in 1898 and they created the test. By the way, I hear that the Canadian Food Inspection Agency has the test for rBST. You may wish to ask them about that some time. It is very neat from what I hear.
We want proof, not someone's version of the truth, senators. Why did Health Canada and the human safety panel incorporate research studies that are not relevant to the pre-established expectations of human safety regulations within our laws?
There is a profound difference in endogenous and exogenous IGF-1. Senator Spivak brought that up this morning. There are binding proteins to deal with. Each exerts different functions; binding protein 2 is an antagonist compared to binding protein 3. More important, if you read footnote 3 on page 4, IGF-1 is known to exert maximum DNA synthesis at low levels by somatomedin or IGF-1 binding proteins.
Your expert panels, and Dr. Maclean from Australia, are looking in the wrong direction. Maximum levels are not the problem; long-term low exposure is the consideration. Therefore, we have two recommendations for the Senate: One, that the Standing Senate Committee on Agriculture and Forestry ensure that Health Canada publicly retract its claim that the human safety expert panel is that of the Royal College of Physicians through all regular media channels and Health Canada's Web site; and two, that the Standing Senate Committee on Agriculture and Forestry ensure that Health Canada expunges any references regarding rBGH in relation to human safety evaluation that failed to meet the following criteria, as listed on page 5:
(a) That any research must show High Performance Light Chromatography readings proving purity of the drug, and;
(b) that the research used must conform to the specified market hormone amino acid profile;
(c) that hormone readings must be from assigned target animals prior to injection and post injection;
(d) that the milk samples must be from target animals injected with proposed market dose and injection periods;
(e) that milk samples must be from injected dairy cows only and that these samples must be pasteurized using all relevant pasteurization scales for milk and milk products and all variations in either composition or percentile of composition be noted;
(f) that Health Canada report how many references exist accurately gauging the effects of rbGH on milk to the Standing Senate Committee on Agriculture and Forestry.
(g) that the Standing Senate Committee on Agriculture and Forestry publish how many references actually qualify as relevant as per Canadian regulations dictate.
(h) Upon verification of qualified and relevant studies pursuant to the above requirements that Health Canada notify all education centers, i.e. universities, colleges, to restrict and eliminate using irrelevant studies and materials in their classes regarding rbGH.
We will be submitting, as I promised in December, our full report on this matter to our board of health to go to all medical officers of health in Ontario once I have Technical Series Report No. 88 in my hands. I cannot go any further until I see the review of that.
No one is above the law. We have an excellent dairy industry in Canada that was built on a solid regulatory basis of caring, compassion, listening and understanding. However, currently I fear that it has gone into a state of dysfunction, and we would like to help rectify that problem. We stand ready to heal, if we can.
The Deputy Chairman: I should point out to the committee that Victor Daniel is from rural Ontario. I do not know if he still is a dairy farmer, but he was one, and he knows the dairy industry very well.
Mr. Daniel: I still work with cows every day. I just make money off the rich dairy farmers, as you said. I just trim the cows' feet, listen to Toronto and read a lot.
The Deputy Chairman: I wanted to make it clear that you are not a resident of Toronto.
Mr. Daniel: I am a rural advisor to the city.
Ms Jo Dufay, Campaign Coordinator, Council of Canadians, Panel on Continuing Concerns: Mr. Chairman, I represent the Council of Canadians. We are an independent, non-partisan, public organization. We were established in 1985 to provide a critical voice on key national issues. More than 100,000 members support our work in communities right across this country.
The Council of Canadians applauds the Standing Senate Committee on Agriculture and Forestry for its thorough examination of the topic of rBST and for its sound recommendations designed to protect the health and well-being of Canadians. In the words of our chairperson, Maude Barlow, when you released your report, "Thank heavens for the Senate."
The Deputy Chairman: The chairman of our committee, Senator Gustafson, has received over 1,000 messages from across Canada congratulating the Senate for the work it is doing on this issue.
Ms Dufay: That is an indicator of the importance people attach to this subject. They are expressing a sincere appreciation for that work.
Recombinant bovine somatotropin, also known as bovine growth hormone, BGH, was the first genetically engineered product for which approval for use in food production in Canada was sought. It should have been a showcase opportunity for the Canadian food and drug approval process, but, instead, it almost became a case study in the inadequacies of our system. The only unequivocal proponent of this product is the manufacturer, Monsanto. Farmers are not clamouring for it, consumers do not want it, and Health Canada recently decided not to approve it. Why, then, are we still talking about this drug?
There are two reasons. First, despite all the reasons the drug is not approved, we may yet end up having to take this product. Second, in the course of observing how this drug has been handled, we have uncovered some unpleasant facts about whether the Canadian drug approval process is or is not working. Those concerns are further strengthened by what we heard in the testimony of the Health Canada scientists this morning around Revalor-H and Revalor-S.
Could we still end up with the bovine growth hormone in Canada? We could, possibly, in one of three ways.
First, Canada could find itself facing a trade challenge following a decision of Codex Alimentarius. In fact, Monsanto is rumoured to be planning a challenge to the EU ban on the bovine growth hormone.
I will not get into lengthy detail about the Codex Alimentarius. I used to teach anatomy, and when I came to describe the knee joint, I would say that a person could learn about the knee joint in two words -- it is "very complicated." To that extent, the Codex Alimentarius is a lot like the knee joint.
The Codex Alimentarius is designed to set minimum standards, which are voluntary. With the emergence of international trade deals, the WTO treats Codex rulings as a kind of gold standard. What are meant to be minimum standards actually become maximum standards, and what are meant to be voluntary guidelines become a minimum requirement for countries to observe.
The second way in which we could possibly face bovine growth hormone in Canada is through cross-border imports of meat or milk from BGH treated animals. With the attacks on Canada's milk marketing system, as well as imports of dairy solids and meat products, we could well end up with BGH residues in the food we have in Canada.
Claims of human health safety are very important to that issue. Although those have been rejected at several levels -- and I note, in particular, this committee's recommendations with regard to further studies on human health and safety -- Monsanto is going around claiming that Canada says BGH is proven to be safe in humans. That is a wilful and profoundly misleading assertion, and it is one that Health Canada should endeavour to correct.
Finally, Monsanto is challenging Health Canada's decision on the bovine growth hormone. That challenge is under way and it is under wraps. It is a confidential process, and it could very well be subject to the same problems as the initial review for this drug.
We have a series of recommendations to deal with the potential situation that we end up with BGH inadvertently coming into Canada.
First, we have a series of recommendations surrounding Canada's position at the Codex Alimentarius to do with labelling, to do with factors that can be considered and to do with the Joint Expert Committee on Food Additives, JECFA.
Second, Health Canada must treat Monsanto's challenge to the ruling on BGH in an open and transparent way, consistent with recommendations 1, 2, 4 and 5 of this committee's March 1999 report and in a manner consistent with the precautionary principle. We urgently request that the Standing Senate Committee on Agriculture and Forestry monitor this process until its conclusion.
Third, until or unless the studies outlined in this committee's recommendations 4 and 5 of March 1999 have been submitted and reviewed by Health Canada, Health Canada should clarify that it has not approved the human health aspects of BGH as claimed by Monsanto.
What have we learned about the drug approval process with respect to BGH and other drugs? The dramatic unfolding of the story of the review process of BGH within Health Canada and today's revelations with respect to beef growth hormones has shaken the confidence of Canadians in this vital part of our health protection system. It is of the utmost importance to restore the confidence of Canadians by a thorough examination of the problems encountered and by providing remedies to those problems. It is perhaps most immediately important to address the question of whether any other drugs have been approved through this inadequate process.
This committee has recommended a government evaluation of Health Canada's drug approval process, either in conjunction with or subject to a review by the Auditor General.
The committee also recommends that Health Canada officials report by June of this year on initiatives undertaken to resolve what are described as management problems. Those are contained in your recommendations 3 and 7.
With all due respect to the excellent work done by this committee, the Council of Canadians believes that the problems encountered in reviewing BGH are symptomatic of problems that extend well beyond the phrase "management problems." We believe it is a systems design problem. These problems require thorough investigation by an external agency which is open to public scrutiny and input. That, in our view, is an unrestricted judicial inquiry. I will not recap here the inadequacies in the process. You have heard a lot about those. Rather, I wish to try to point out some of the underlying features and suggest remedies.
First, the Health Protection Branch is insufficiently independent. Its mindset references to industry as the client.
Second, there is the question of its funding. The cost-recovery initiative means that 90 per cent of the Health Protection Branch's budget related to drug review and approval now comes directly from industry.
Third, the Health Protection Branch must have independent scientific capacity in relatively small and specialized fields. Truly independent scientific advice is very difficult to come by. I have appended to my notes the report that the Council of Canadians did on the two external panels used in reviewing bovine growth hormone.
We must also look at the ability of civil servants to protect the public interest. The scientists from within Health Canada who have testified before this committee have taken brave steps to inform the public about their important concerns, and their actions can probably politely be described as "career limiting moves." Frankly, I do not know how they have had and continue to have the courage, the perseverance, and the bravery to do what they have done. The gag order which now prevents them from speaking in a publicly about their experiences and concerns does not serve the public interest. We believe it should be removed immediately.
In order to restore Canadian public confidence in the evaluation and the approval process for new food and drugs in Canada and to ensure the safety of products approved, we recommend, first, an immediate unrestricted judicial inquiry into health Canada's drug approval process; second, a revision of the funding mechanism for the Health Protection Branch to ensure the independence of this branch of government from corporate interest; third, the protection of the Health Protection Branch's independent scientific capacity through adequate and qualified on-staff scientists; fourth, re-evaluation of the role, if any, and guidelines for external panels to ensure the independence and the capacity of those bodies to thoroughly execute their assigned role; and, fifth, clarification of guidelines which support the ability of civil servants to speak out to protect the public interest where this is otherwise in jeopardy.
After hearing this morning's testimony I would add a sixth point, namely, that the Minister of Health be asked to immediately release the documents provided to him by the scientists and, in addition, that Canada re-look at its current dispute under the EU that concerns some of the hormones that we have learned more about this morning.
BGH is not approved for use in Canada today because of huge public pressure, because of brave whistle-blowing scientists, and because of thoughtful political work as exemplified by this committee, which have combined to insist upon due diligence. I am not certain that due diligence would have occurred in the absence of those combined external factors. Not every drug will receive the spotlight attention that has been afforded to BGH. Canadians need a drug review process which guarantees their safety. We also need answers to questions raised in the case of BGH and about other drugs which may have been approved in similar circumstances.
Canadians need to protect our sovereign right to regulate food and drugs within this country. Once again, on behalf of the Council of Canadians, I thank and congratulate this committee for its important work.
Mr. Michael McBane, National Coordinator, Canadian Health Coalition: We, too, wish to express appreciation on behalf of health activists across the country for the work and the diligence of this committee in investigating an extremely controversial and important area of the government's work.
One of the weaknesses in our democracy is: Who investigates the government? It is a problem, as it is in most democratic societies. Where do you go to get an independent investigation of a serious problem?
The Deputy Chairman: The Senate of Canada.
Mr. McBane: Keep up the good work! We also want to thank Senator Kinsella for his recent motion. Acknowledgement of the need to protect the scientists who are protecting the public as opposed to the industrial clients is important.
We have tabled before you today a document called, "Transition is Abdication," a citizens' guide prepared by the Health Coalition which analyzes the Health Protection Branch's legislative transition process. I want to table this with you because we have systematically analyzed the stated goals and objectives of Health Canada's health protection transition. We have noted in your excellent interim report that the public should trust this initiative, and that you support it to the extent that the initiative seeks to involve the public and thereby enhance transparency. The documents prepared by Health Canada notes the guiding principle that Canadians will be consulted.
On April 28, I believe, Health Canada actually put on their Web site the results of the first rounds of consultations on the Health Protection Branch. It is called, "National Consultations Summary Report." The Canadian Food Inspection Agency is mentioned in this report. It states that Canadians expressed concerns to Health Canada that food safety responsibility is being shifted to Agriculture. Voices expressed concerns that the priority at CFIA is to promote food and trade. They consider the agency to be seriously understaffed, and they say that the responsibility for inspecting food should remain with the Minister of Health.
On the same day that this consultation report was tabled, the Minister of Agriculture tabled Bill C-80, a new food bill which rips apart the Food and Drugs Act. This is the most important and the most dangerous piece of legislation being proposed, and it has been tabled as a real sleeper in the house.
We are right in the middle of a growing sense of crisis in public health protection. There have been consultations which have found that Health Canada should be in charge of food safety, not Agriculture, yet this bill would transfer all responsibilities for food inspections, food investigations and food compliance on safety to a trade promotion agency. This is what Bill C-80 is about. It is very serious.
We want to draw this to the attention of your committee because we believe you are in a position, together with the Canadian people, to prevent passage of this bill. That is essential. We must stop tearing apart our health protection legislation and get back to implementing and upholding the law.
There is clear evidence that this kind of model, where the food promotion people are responsible for food safety, does not work. This was tried in England, as you no doubt know. The Thatcher government deregulated food safety. They moved it from their department of health and left that responsibility with their department of agriculture. However, they were unable, with that new arrangement, to control mad cow disease -- so much so that the new Prime Minister sent it back to the department of health.
Bill C-80 transfers responsibility for food safety to an agency that has no expertise. They no longer have inspectors. They tell Health Canada that they do not want the scientific research that has been done by that department. Basically, they are cutting out the research and saying: "Our client is the industry." This is an extremely serious situation.
We have outlined the objectives of health protection legislation and we based our objectives on evidence. We have access to information documents from Department of Justice lawyers who have stated that the Food and Drugs Act must be broken apart because it is too uncompromising on safety. That is what Bill C-80 does. It breaks up the Food and Drugs Act and deregulates it.
Therefore, I urge you to reconsider your endorsement of the Health Protection Branch transition process. It is not enough to involve people in consultations. We do not want to be involved in the dismantling of our laws that put safety ahead of industry. We have to look at the legislative agenda, not just the consultation process.
As to Bill C-80, we urge that food safety enforcement, product health inspections and investigations of food poisonings be sent back to Health Canada where the expertise is and where it needs to be strengthened.
I have one final anecdote. Over the Easter weekend, The Toronto Star published a major investigative report on the Canadian Food Inspection Agency, the agency which promotes biotechnology in food. They are incapable of dealing with salmonella in cheese or bacteria in strawberries. Yet, we are putting them in charge of biotechnology safety. They stopped the Toronto health department and the Ontario health department from finding the source of a salmonella outbreak because it would be bad for their industrial client if the citizens were to know this. This was all published in The Toronto Star and verified by the Ontario Department of Health. This is a major conflict of interest. I urge you, honourable senators, to stop this bill, to protect Canadian food safety and to protect our Canadian food producers.
Mr. Peter Dowling, Ontario Coordinator, National Farmers Union: Mr. Chairman, I am a farmer myself and I do milk cows. We have put together some speaking notes in point form. It is difficult to write complete sentences and drive a tractor at the same time. Please bear with me.
I would like to thank honourable senators for having us back again today to address our further concerns. Farmers are quite concerned about BST, not only because it makes our cows sick but because it also threatens our market and our marketing system which has been established and proven to be in the best interests of Canadians.
Food safety is also of concern to farmers. We need functional safeguards to protect the health of Canadians. Canadians need to trust the system. We need to restore the integrity of our system.
We have outlined a few issues of concern. Most of them you have heard many times before. Thus, I will not go into any detail.
We note that the mess at Health Canada persists. They are speaking in one way and acting in another. We are concerned that the human health panel report has been held up as the document on human health safety when it has been shown that it is a flawed and, perhaps, even fraudulent document. The gaps analysis has not been addressed. The gag order is of concern, and not only for the reasons that have been discussed. Our scientists are part of the peer review process. Their input is essential in determining what the real science is in these issues.
We are concerned about the emphasis on speed of approval as opposed to caution. What difference does it make how long it takes as long as the job is done properly in the end? To try to meet timelines seems rather frivolous. Canadians like to think of themselves as being cautious.
The use of the external panels is another concern. The joint program management advisory committee is a conduit for corporate influence and pressure. Mess-ups at the international levels have been detailed this morning by several witnesses.
On the issue of confidence in Health Canada, we think that it goes beyond just developing confidence. One cannot be confident in a system that does not have any integrity. Thus, we have to restore the integrity of the health regulation system.
With the precautionary principle, we are looking for guarantees and safeguards before things are approved. With risk management, it is really a case of, in the extreme, how many dead bodies are we willing to accept before we approve something. We need to strengthen that process.
The Health Protection Branch transition is a tool being used to move Health Canada from the watchdog of Canadian consumers to a service provider to the drug trade. We oppose that. It should be scrapped.
What do we need to do? We have set out some recommendations. The first is a legislated ban on bovine growth hormone. Given the drug is harmful to cows and that scientists are still debating the health issues, we think that legislation would be appropriate to ban the product from Canada.
A judicial inquiry is a good idea. It should have the power to lay blame and to investigate. It should have a fairly thorough mandate to tidy things up, point fingers at where the blame belongs, and prosecute where necessary.
Another job is to restore the integrity of the Health Protection Branch. It is not that there is a lack of confidence, it is that there is a lack of integrity. Scrap the Health Protection Branch transition and disband the joint program management advisory committee.
In the list of legislation required, the precautionary principle is one thing that we are concerned about. The Food and Drugs Act places the precautionary principle as fundamental to and inherent in that legislation. It uses words such as "shall not sell," "manufactured in ways which may cause harm," and so on, to imply the precautionary principle. Yet, it is not stated and defined adequately. We believe it should be affirmed and, perhaps, even should be explicit in the legislation, although there are some hazards in doing that as well.
We much appreciate the sober second thought that has gone into your work here, senators. Canadians appreciate the fact that you are responding to their concerns. We have suggestions on issues that we would like you to look into and pursue further. This is our short list.
It is a myth that genetically modified foods are here to feed a hungry world because those are not the crops that are being used to feed hungry people in the Third World. Seventy per cent of our exports of food end up in the developed world. Soybeans and such products do not go to feed hungry people. It is more an issue of control of our food supply. Everyone has to eat, and the Monsantos of this world are working toward getting a piece of everything that enters our mouths.
This committee has offered some much-needed balance and democracy to our food system in dealing with these kinds of powers. We thank you for that and ask you to keep it up.
The Deputy Chairman: Thank you, Mr. Dowling.
Mr. McBane, I had a lot of experience dealing with food safety when I was Minister of Agriculture, and I always thought we did a better job than the health department. After all the evidence we have heard here about the health department, I am amazed that you would recommend that anything be transferred to them.
Mr. McBane: That is a sad comment on the state of our health department, but you are right. The level of trust is very low, but the reality is that the food directorate of the Health Protection Branch is the only area of government that has expertise in food safety surveillance, and they are being cut. They are on the verge of elimination. Even though the minister intervened with a moratorium on the cuts, and even though there were new monies in the last budget, senior managers refused to replace anyone, except on a temporary basis. They have not allocated that money to badly needed scientific surveillance. As Peter mentioned, when you move to risk management, you do not need to prevent disease; you manage it.
The reality is that the food inspection function, the investigation of breakdown in safety, and the anticipation and research to set standards all belongs in the health department. That is recognized even in the United States where scientific food associations have all said that the food promoter should never be handed responsibility for safety. No department of agriculture in the world should be the final arbitrator on food safety. That should be the job of the department of health. Our job is to clean up the Department of Health.
The Deputy Chairman: I recall returning from a meeting in Europe, while I was Minister of Agriculture, to learn that an order in council had been passed providing that we quit inspecting canned mushrooms at the port of entry. We found human excrement, rat hair, steel, mud, and I forget what else in cans of mushrooms from the Orient. Under that order in council, instituted by Health Canada, food inspection would be done on the store shelf.
Various embassies, et cetera, complained about what a trade restrictionist I was. The warehouses in British Columbia were full of boatloads of mushrooms. I do not know what they did with them, but they had to take them back.
You are telling me that this has changed. There was a big meeting the other day here in Ottawa on food safety. We were not invited to attend. Maybe you were there.
Mr. McBane: I went to a Canadian Food Inspection Agency briefing which I happened to find out about just the Friday before the Codex meeting in Ottawa. There they tabled a study from the nutrition association saying that Canadians are not intelligent enough to deal with the labelling of biotechnology foods. They said that there is such extensive use of this technology that they could not possibly identify it all, that it is too prevalent. That is outrageous. It is because they do not know what the threats are and they do not want the public linking liability to potential health outcomes in the future.
It shows that the CFIA's client is industry. In this case, it is Monsanto. At these meetings, they are almost sitting in each other's lap. They show disdain for the public. CFIA's position at Codex, which reports to the Minister of Agriculture, is that there will be no mandatory labelling of biotech. I was told by the office of the Minister of Health that they did not think that decision had been made. They were trying to downplay the fact that the Canadian government is not firm on its position, but it is clear where the CFIA is going and who their client is.
The Deputy Chairman: I thought it would be a great idea if a couple of senators went to Codex and had voting power. However, I am told that, because I am not a scientist, I can only be an observer. That utterly amazed me because we built the biggest research branch of any branch of government to ensure that the food we produce is safe. However I can only be an observer because I am not a scientist. It would be very difficult for me to go to any meeting and not have my say.
Mr. Daniel: On December 7, I made a promise to Senator Spivak with regard to genetically engineered foods. I was on a committee with Health Canada's foods biotechnology communications network and the Quebec consumers' association. Members of the staff from two universities were also involved. We have just finished our report. It will be delivered to the consumer affairs branch of Industry Canada in two weeks and will be released next month.I do not think CFIA will like us too much because we did a very thorough investigation. There are many matrixes in there and there will be many surprises. The door should be left open.
Senator Spivak: Would you send us a copy of that report?
Mr. Daniel: I will ensure that you personally get it.
Senator Spivak: It is a tall order for the Senate committee to attack the systemic shift from protection of food in the public interest to protection of huge corporations who actually do not need any protection. The power is not balanced. It is not that we are not up to assuming the challenge; the question is whether we can deliver.
If Codex Alimentarius decides that there is no problem with rBST, what sort of powers would the City of Toronto have to limit this? I realize this is a federal issue, but I am not clear what mandate and power the city has on this.
Mr. Daniel: Federal-provincial relations certainly make things interesting. The medical officer of health in any municipality in Ontario has the right to deal with food that is adulterated or contains a harmful substance. In Ontario, under the Milk Act, milk may not contain any foreign substance. Therefore, we can go through an approval process and we can inform our medical officer of health, who can inform the provincial association. We can go to the Minister of Health in Ontario and state that we have a conflict regarding adulteration of food products within the definition of foods under the Health Protection and Promotion Act. That is what we do. We can initiate due process.
Codex may say that something is safe, but we do not recognize Codex. Milk is defined under the HPPA.
You asked about the difference between sound science and trade. I will give you an example, because my job is to research the regulations.
The last time I was here, I stated that the federal definition of milk currently under the Food and Drugs Act is that milk shall be the normal lacteal secretion obtained from the mammary gland of the cow. If I am to scientifically interpret that, that definition is unfit for human consumption in Ontario. In Ontario, milk is from a cow or a goat, and that milk must be free of colostrum. Colostrum is part of the normal lacteal secretion. That was the federal definition in 1974, that milk shall be the normal lacteal secretion, free of colostrum, under division 8 of the Food and Drugs Act regulations.
We do not push that definition because we never had to look at it in that way. However, with genetic engineering, if you get into a safety issue, genus bos does not constitute a genetically engineered product. Milk cannot come from a genetically engineered organism that looks, walks and moves like a cow.
Herman the bull had human protein inserted into him. He has eight or nine daughters milking now through one of the biotech firms. I have a file on Herman, but I have not updated it lately. Those cows produce lactofferrin in their milk, not lactose, so that is not bovine milk, but it is safe. Science works on definition and measurement. Our laws try to do that, and we are using the milk issue as a good learning curve. We are learning a significant amount from this.
Senator Spivak: Let us say that the Codex Alimentarius determines that rBST is safe. Monsanto then uses whatever approach is appropriate to sue the government. The government shakes in its boots and does not think that it is wise to continue with the rBST inquiry, since so many people have said it is safe, despite all the misrepresentations.
Can the Province of Ontario, the City of Toronto, the Association of Rural Municipalities, or any association of cities across the country insist that the federal government not approve this milk?
In the past, careful consideration has been given to provinces. When trade negotiations are ongoing, the provinces are always consulted. We do not want to do anything that might offend the provinces, especially in light of provincial jurisdiction. Do you have any suggestions to make?
Mr. Daniel: I will give you a hypothetical answer.
Senator Spivak: The approach must be legal. It does not help to simply protest.
Mr. Daniel: We would need to ascertain the science as it is applied under our regulations. Neither Codex nor JECFA technically recognizes Canadian law. If one were to go to the JECFA documents, one would be hard-pressed to demonstrate any reference that brings forward the fact that milk is already defined scientifically in federal jurisdictions in any country.
It is assumed scientifically that milk is milk. That is defined under our law. The question is why are our laws not being brought forward? We would just say that the international science has gone against the position of the boards of health in Ontario. The position from 1994 and 1995 is that we wanted to see evidence proving human safety. All we have seen is this mass of paper. I totally sympathize with anyone who must read all of this information. I have 80 feet of it in my office. There is no evidence.
If the science is to be science, then there is already an existing protocol regarding milk, the way it is to be handled, pasteurization, the type of animal producing it, and the composition within milk. All these are under our laws and were incorporated in law prior to the signing of these agreements.
Milk was defined in 1974. The Free Trade Agreement did not come into force until 1988. The federal Animal Pedigree Act is the foundation for all the registered livestock in Canada. That act is recognized as containing the preferred definition of registered livestock.
The board would have to have the information. We would put forward our presentation and they would make the suggestion. It would then go back to the legal department, because we have already done that once.
We did receive a preliminary report, which is why we are here learning, negotiating and pointing these things out. Every time I come back, I learn something more, and that makes my position more solid.
Senator Spivak: This is an issue of trade law. Litigators of trade law will eventually end up dealing with this.
I am persuaded that we were rather soft on the transition process and we were rather soft on restoring the confidence of Health Canada.
I want to delve into the issue of a judicial inquiry. I understand that you are suggesting that this is as important as the blood scandal and the Krever inquiry. This is what it would mean if this committee were to imbue this issue with that amount of gravitas.
Do you think that this is such a broad issue, with so many different facets to it, involving Agriculture and Agri-Food Canada, the Canadian Inspection Agency, the Health Protection Branch, industry and government policy, that this is the way to go? It would be a very serious step for us to suggest it. I do not know whether it would be accepted.
Ms Dufay: The short answer is, yes, that is what we believe is necessary, senator.
Even if you only consider the evidence that has been presented to this committee, that raises significant concerns. An internal review demonstrated that none of the normally required, long-term toxicology tests or tests for human safety had been performed on this bovine growth hormone. This drug was close to approval on a number of occasions and had received sign-off on human health just two weeks after 14 volumes of material were submitted to the department.
When you look at the inconsistencies which this committee has noted in the testimony of Health Canada officials to this committee, compared to records that exist outside this committee; and when you look at allegations of pressure, coercion and offers of money, that all adds up to a tremendous amount of potential wrongdoing within what is supposed to be a public safety process.
You add to that the evidence that we have heard this morning from Health Canada scientists that beef growth hormone drugs, already approved and in use in this country, have profound effects on cattle. Then you hear that those drugs were approved by department managers despite the concerns of scientists. As Margaret Haydon said, her concerns fell on deaf ears. How can any of us living in this country have confidence in the safety of food and drugs when we hear these shocking testimonies? Yes, we do believe that an unrestricted judicial inquiry is required.
I would return to your trade question. Mr. Daniel has spoken of the process from the federal government down. I want to speak of the process from the federal government up, in a court challenge. Suppose a WTO challenge were mounted on Canada's decision to disallow bovine growth hormone, or if at some future point we decided to ban the import of meat or milk from BGH-treated animals. The WTO would ask if this is a technical barrier to trade. Is a restriction posing as science created to keep out fair trade?
The WTO would then try to establish what is okay and what is not okay at the international level by looking at the recommendations of Codex Alimentarius. If Codex decides that BGH cannot be labelled or that there are no maximum residue levels for Codex, then the WTO would rule against Canada.
Under the WTO, countries can be forced to change their laws. Unlike NAFTA, the WTO has the power to reach in and require countries to re-write their laws. If we do not do that, we face international tariffs. It is unlikely that this government would actually countenance such a situation. We have already seen, in the NAFTA case of the gasoline additive MMT that, rather than go down that road, the government rolled over and allowed what had earlier been described as an insidious neurotoxin into the country and gave the company some "go away" money for good measure.
Senator Spivak: They labelled it safe.
Ms Dufay: Yes, they did. On issues of provincial and federal rights and trade deals, there is certainly some level of consultation. For instance, in the case of bulk export of water and NAFTA, the government appears to have conceded some important measures of control away from the provinces under the North American Free Trade Agreement. I will not go into details here because it is not the topic of discussion.
Ms Rickman: Another matter that needs to be reviewed is the relationship between the Health Protection Branch and industry. Health Canada has already declared that industry is its client, but there is a much more incestuous relationship there which is very important to note, especially in light of the appeals process.
Monsanto has said they will appeal the BGH decision. The panel is set up to be done behind closed doors, without public participation, having three members, one appointed by Health Canada, one appointed by Monsanto and the third agreed on by both parties. I am having difficulty seeing the difference between Health Canada and Monsanto at this point. It is very important to examine that relationship. otherwise, all the work we have done here will be futile because, essentially, Monsanto will get its rubber stamp in the long run.
Mr. Dowling: Senator Spivak asked a question about a judicial inquiry. We think that is an essential approach. Many other approaches have failed in the past. Various ways of trying to address these concerns about the integrity of the department have failed. We need something with the powers of a judicial inquiry to try to resolve this issue and restore confidence in the department.
Mr. McBane: We did not call for a judicial inquiry partly because Mr. Justice Krever was tied up in knots. He faced tremendous restrictions by the executive, in this case the Prime Minister. You will notice that, in spite of the Krever inquiry findings, no officials have been brought to task for their dereliction of duty. They are all still on location. The destruction of documents has not been explained. The companies who imported the product illegally have never been charged.
The signal throughout government is that you are supposed to protect your client in this way. All of Mr. Justice Krever's efforts were in vain. This is a huge task. There is no magic solution in just bringing in a judge.
I think of John Ralston Saul's book, The Unconscious Civilization. There has been some very serious reflection on the extent of the corporate takeover of government.
Senator Spivak: Walter Stewart also writes on that topic.
Mr. McBane: Yes. A number of Canadians have given profound thought to this issue. You would not be alone entering into this field. Perhaps there is a role for a parliamentary committee. If it had a research budget and had the political will, it could do much to help.
The Deputy Chairman: Mr. McBane, you just touched on a very important subject here, that is, our research budget. This committee and other parliamentary committees are restricted as to our expenses. Our researchers are from the Library of Parliament. We try to include money in our own budgets for research, but we are limited. The press is attuned to the fact that we, apparently, are the big spenders.
Do all the other witnesses here agree with Mr. McBane that the health department will be the saviour here? Perhaps I am putting words into Mr. McBane's mouth but I have strong reservations about what Health Canada has been doing and is still doing. We heard from the scientists again today and they plan to submit to us 52 pages of irregularities.
I used to take great pride in our food inspection system. We had highly qualified people. We were one of the few countries in the world that never got into trouble. That is when we had control. We had sovereignty.
Mr. Daniel: I have been dealing with this file on bovine growth hormone for five years. I have come to the conclusion, in negotiating with my farm neighbours, government, Toronto, that everyone speaks a slightly different language. They have a slightly different intonation and a different meaning.
I cannot concur with Mr. McBane's request that this question be left solely with Health Canada. One of the biggest problems faced by the Toronto Food Policy Council and the boards of health is getting the average citizen to understand how the food system works.
The reason the bovine growth hormone issue is in such a mess is that the regulators do not understand the regulations and how the regulations interlink, and why they interlink. The farmers do not understand the clauses. The clauses are not complicated; they are contained on one page. We need to get everyone at the table to discuss these matters.
I have here the Dairy Industry Act, 1914. It is the last piece of sensible legislation I have ever read because it put everything together, including the role of the farmer, the role of the Health Protection Branch and the role of municipal governments in protecting farmers and consumers. It is all there. It even deals with odour tables for milk. It specifies which plants cause an odour if they are consumed by cows. That is also contained in the new act, but in this one it tells you what plants cause the odour. The new one is subjective, not objective.
The latest issue of the Canadian Veterinary Journal says that there are no human safety concerns, thanks to the safety panel we have all discredited this morning. Will someone not stop and take the time to think before they write about who says what? That is in the Canadian Veterinary Journal from March, 1999, Volume 40, No. 3. It stated that the government takes rBST based on the CVMA expert panel report. There were no human concerns at all thanks to the human safety panel of the College of Physicians and Surgeons. Now all the veterinarians across Canada have this message wrong, but we trust our media.
I have talked to the CFIA inspectors. We have three in our area to do eight counties, and they also deal with feed. Did you know that if you make feed on your farm, you must put a label on it? I did not know that. If you make your own feed, grind it up and put a ration together, you must make your own tags. The CFIA inspector told me that. There are many little nuances, and we have overlooked the basics. It is time to bring the basics back and to use language everyone understands.
I cannot say I support a judicial review because I would have to discuss it with my council and the board, but I would prefer a negotiated settlement. We could work together We could compare the new regulations and the old regulations. We can talk about the whole subject.
I think CFIA and all farmers have a role to play. Mr. Dowling plays a role, and OFA plays a role. We need Health Canada to give us the scientific basis for why we do something.
The Deputy Chairman: I want to come back to the WTO for a minute. The new president of the WTO is a former prime minister of New Zealand. He was elected last week. He beat out the Malaysian by three votes. New Zealand and Australia have both passed laws against rBST. Do you have any opinion as to what he will do now with the WTO?
Ms Dufay: I do not have an opinion on that, but I have a piece of information which you need to add to that picture. Last week, the U.S. ambassador to New Zealand appeared on public television in New Zealand threatening trade sanctions against that country if New Zealand implemented an intended law requiring labelling of foods produced through genetic engineering. I think that, very quickly, we will see the cards shake down with regard to this new president of the WTO.
The Deputy Chairman: I understand also that, at the recent Codex meeting, Australia and New Zealand did not vote with the Americans. Only Argentina voted with the Americans.
Ms Dufay: That is correct. In fact, the issue under discussion was the labelling of genetically engineered foods. Since the discussion at Codex a year ago, support for the U.S. position, which opposes labelling of GE foods, has crumbled away. They are clutching at fig leaves now and trying to convince people that consumers do not have the intelligence to understand that when something says it is BGH-free, it means it does not have any BGH in it, or something like that.
Senator Spivak: Is that a change in position since the convention, meaning a change in the position of countries including Canada? Do you have any information on that?
Ms Dufay: I have some. The Codex process, and the Cartagena protocol which is adherent to the Rio convention are separate processes. The U.S., although it was extremely influential at Cartagena, does not have a vote in that process because it is not a signatory to the Rio convention. Although the U.S. was certainly exerting a strong influence formally, it was Canada that was carrying that particular bag forward.
At the Codex meeting last week, Canada underwent a subtle but very important shift in its position vis-à-vis food labelling and essentially said that it could not support the U.S. position. A year ago, we were right there with the U.S. Whether that will translate into some changes in Canada's position in the Cartagena protocol is questionable. The Cartagena process is now mobile, and the next round of hearings will be in Montreal, in either September, November, or January. It will be very important to follow that process as well as the Codex process.
The Deputy Chairman: If I may ask before I move too far away from my line of questioning about the WTO and the food safety group, who is the director of the food safety group in Canada? I cannot remember his name right now. He was a former minister of agriculture in Saskatchewan. The present Minister of Agriculture from Saskatchewan is saying at the WTO meeting that those GM seed products are the way to go to make money, and so does the former minister who is head of the food safety group. He is a veterinarian. My advisor reminds me that it is Lorne Hepworth.
I am so shocked that we seem to be getting further away from elected parliamentarians having anything to say. They do not want you to have very much to say about it. This committee has an old saying: If you open a can of worms, you go fishing. We have gone on an expedition here that has taken us far beyond anything we expected.
Mr. McBane: Senator, you questioned the role of Health Canada. It is important to make a distinction between the senior managers who the scientists have described as having economists' background and MBAs versus the scientists. The scientists are world-renowned, and they are being driven out of the country because we do not value research science.
The scientists at Health Canada's Food Division discovered dioxins leaching into the milk from the cartons from the paper industry. They set the world standard. That was cleaned up. That is what Health Canada did before the business managers got in there and decided to manage risk instead of prevent health problems.
It is important to distinguish between the senior managers who are now trying to destroy the science base and the science expertise that is still there. It is a major distinction. The science experts are saving lives and would save more lives if they were given the budgets. I think it would be a disservice to Health Canada not to make that distinction of the senior managers versus the scientists.
The Deputy Chairman: Wait a minute. You are the one who made a statement first without drawing any distinction. No one admires good scientists more than I do, and they were in Agriculture Canada and they were in Health Canada too, but that does not mean that they were perfect either, as far as that goes. Health Canada and Agriculture Canada at one time both had top scientists in charge of everything. In Agriculture Canada, there was not an unqualified person from Treasury Board or Finance or Trade or Foreign Affairs. When I was your minister, they were all agriculturally trained people who knew what they were doing and were respected all over the world. We had the safest food in the world when we were a sovereign nation.
Mr. Dowling: On your question regarding food safety going to Health Canada, things have changed since you were the minister. When you were there, we did not have the CFIA with its dual mandate to adhere to Agriculture Canada which conflicts with its mandate as a safety watchdog. The other thing that has changed is you are no longer the Minister of Agriculture there.
The Deputy Chairman: Many people do not know that.
Mr. Dowling: Not many departments have ministers like you when you were the Minister of Agriculture.
The Deputy Chairman: When I went to my first OFA meeting, I was the only minister out of 132 who had a background in agriculture. They were all professors, or had some other qualifications. They were from all over the world. Some of them did not know a sow from a cow. When I was your minister, I was extremely lucky that all the staff members loved agriculture. They were trained in agriculture.
My deputy minister, Mr. Williams, had never worked for anyone but Agriculture Canada from the time he was a student at McGill, except when he went overseas during the war for four and-a-half years. When it was suggested that he be transferred to another department, he retired. He had never worked for anyone else but Agriculture Canada in his life and he did not wish to work for anyone else. To me, he was a genius at keeping me out of trouble and helping me do a good job.
Mr. Dowling: Just to complete my thought on that, what we are looking for is a body that is independent and powerful, that is protected from corporate lawsuits and is legally accountable to the public. There is the shopping list.
The Deputy Chairman: I must say that I was very much against privatization of the inspection service, and I am still appalled and shocked at how we are doing our research now. I used this terminology before, and Monsanto is the example I will use: there was a $600,000 grant to Agriculture Canada and now they are taking over a building at the research station, and then we find out about wheat that is Round-Up resistant.
Senator Kinsella: I should like to get some specificity on the observation of our witnesses as to the appropriateness of a forum that would continue to inquire into this matter. The suggestion was made that this committee make a recommendation for the appointment of a judicial inquiry under the Inquiries Act, I assume. There are many disadvantages respecting an inquiry done that way, as opposed to having an inquiry by a parliamentary committee. A parliamentary committee sets its terms of reference or its own mandate, whereas the government, of course, sets the mandate of any inquiry under the Inquiries Act.
An inquiry under the Inquiries Act reports back to government and it can only make recommendations, whereas a report, study and analysis done by a parliamentary committee is within Parliament where, if legislation needs to be enacted, you are already inside in the engine room.
You might wish to reflect upon the advantages of a parliamentary forum over a judicial inquiry, unless you had something particular in mind that you thought a judicial inquiry could do that a parliamentary inquiry could not do. Do you?
Ms Dufay: I would certainly encourage the Senate to look at all the options for inquiry. Our concern is that it be a full inquiry, and that it be open to the public. That was our major concern about the proposal respecting the Auditor General review, that there is no opportunity for the public to bring in information in an open way. One of the lessons that we have all learned from the BGH experience is that there has been enough wraps on things. We want something that is public, that is open, and that is transparent.
The inquiry or committee must also be able to point the finger at individuals, and be able to take action, both with respect to any wrongdoing by individuals and with respect to systems problems it uncovers.
The Deputy Chairman: Thank you all very much. Our time is limited today. We will now recess now for lunch and resume at two o'clock.
We will be studying your reports and, if you have any further suggestions to make, though you have made many to us today, and many good ones, please do not hesitate to let us know.
The committee adjourned.