Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 23 - Evidence
OTTAWA, Tuesday, November 17, 1998
The Standing Senate Committee on Agriculture and Forestry met this day at 4:12 p.m. to consider recombinant bovine growth hormone (rBST) and its effect on the human and animal health safety aspects.
Senator Leonard J. Gustafson (Chairman) in the Chair.
[English]
The Chairman: Honourable senators, I call the meeting to order. Our witness today is Mr. John Verrall, from the United Kingdom. He has been quoted several times in this room.
Mr. Verrall, we are pleased to have you here today. Welcome to Canada. We look forward to your presentation. Please proceed.
Mr. John Verrall, Member, The Food Ethics Council: It is very kind of you to invite me here today. I am extremely grateful.
As you know, I am no longer Chairman of the Farm and Food Society. I am now a member of the independent council of ethical standards in food and agriculture, known as The Food Ethics Council.
I attend various meetings with the veterinary medical directorate on behalf of the National Food Alliance. I also have close connections with the Genetics Forum in London and the Consumers in Europe group, or CEg as it is referred to.
I am by profession a pharmacist. I have worked in the industry for some 30 years, in both the human and the animal sides. For the last 16 years, I worked nearly exclusively on the veterinarian side, in both product development, and marketing and sales. I retired about ten years ago. I still work part-time for three European companies, and I undertake drug buying for a large seven-man veterinary practice in the U.K. This way I do keep myself well versed on matters veterinary.
JECFA, to which reference has been made frequently during your inquiry, is the scientific advisory body on matters relating to residues of veterinary drugs in food and it makes recommendations to the WHO Codex Alimentarius Commission, which of course, as you well know, is linked to the WTO.
The fiftieth meeting of JECFA, held earlier this year, and its subsequent Summary and Conclusions document have shown that the impartiality and credibility of this body must now be questioned.
Bovine somatotropin, as you well know, is quite unique in that it is the first product of biotechnology and genetic engineering to be used in a non-therapeutic capacity for yield enhancement. As a result of the consideration of this product by JECFA, it is now obvious that certain activities and functions of JECFA should be examined as a matter of urgency and in detail.
The points I wish to make about JECFA are these. First, there is a lack of transparency and an apparently secretive operation that allows the distortion of scientific evidence for what can only be regarded in this case, I think, as politico-economic expediency. The full report on the fiftieth JECFA meeting will not be issued until March 1999. The WHO FA Series No. 41, which is the residue monographs, is due out now. I believe some people have seen it; I have not. However, the Summary and Conclusions document, which was issued after the initial meeting, was considered at the residues committee in Washington in September of this year. It is amazing because they had no detailed residue monographs to go on at all. There was apparently no consensus, but the report on that residues meeting in Washington has yet to be issued.
The second matter I wish to pursue is, in fact, the manner in which persons are selected for memberships of JECFA, the selection of members for principal roles in specific reviews, such members associations with each other, with other organizations and companies, and whether any factors might be regarded as a conflict of interest.
Principal players at the fiftieth JECFA meeting, if you have looked at the list, will be obviously mostly from the U.S. FDA, with the same national interests, responsible for, or associated with, the making of a previous decision on the very same matter, rBST in the U.S.A.
The third matter that must be examined in this respect is the questionable presentation and content of the Summary and Conclusions document of the fiftieth JECFA meeting. If you study this, there is a total omission of some matters of grave concern that have been brought to the committee's attention, whilst other matters of concern have been diluted by the inclusion of irrelevancies. At the same time, matters of questionable importance were featured more prominently. There is no mention at all of the lack of any long-term chronic toxicological data in excess of 90 days. Note the absence of any published study to examine the local effects of IGF-1, in milk, on the gut -- specifically, cyto-kinetic or cellular morphometric studies.
The claim is still made by JECFA and by Monsanto that IGF-1 is destroyed in the gut, when it has already been proven that 67 per cent, in milk, can be absorbed from the gut -- and therefore could not have been destroyed and may act either locally or systemically, or even both.
That a scientific committee can produce such a document containing information presented in such a misleading manner, with incomplete science, without supportive documentation, and with a total disregard for the precautionary principle, I believe to be unacceptable.
Since the last evaluation in 1993, much more information has come to light, both regarding possible adverse effects on human health and on the health and welfare of the cow. The latter was not considered by JECFA. However, I think we cannot ignore it. With an up to 40 per cent increase in mastitis and 20 other side effects at normal dosage level, there are both scientific reasons and also reasons under the term of "other legitimate factors" to ban the use of rBST.
What many people cannot understand is that, in the case of a drug used in a therapeutic capacity for the treatment of a disease or a condition, a margin of safety at least of three times the dose is needed for approval. Yet, here we have a drug used over longer periods of time for non-therapeutic purposes, perhaps 20 or 30 years, that produces serious side effects at one-time normal dosage levels. Why is this being tolerated, allowing no margin of safety? It is a mystery.
It is generally recognized that mastitis, lameness, and infertility are the three most common and serious forms of economic loss in dairy enterprises in all advanced economies. These are also three of the most marked adverse effects of bovine somatotropin on the health and the welfare of the cow.
To briefly consider just two of these 20 side effects, let us look at lameness and mastitis. Reports on experimental work on the use of porcine somatotropin, which is used on the pig, may throw some light on the cause of lameness in cows treated with rBST, which has hitherto not been apparent. There was an article in the Canadian Journal of Animal Science in 1994, on the effects of recombitant porcine somatotropin on joint cartilage and axial bones in growing and finishing pigs, where cartilage problems were described. More recently, salmon genetically engineered with increased levels of growth hormone have also had severe bone and cartilage deformities.
In regard to mastitis, one of the Monsanto personnel giving evidence to your inquiry stated, verbatim, "Even with mastitis we receive almost no reports of Posilac associated with an increase in mastitis", giving the impression that mastitis is not a problem.
If you look back in the history of this, Craven, who is one of the Monsanto employees, released information that there was a 35 per cent increase in mastitis in pooled data taken from 14 herds.
Since the EU Committee on Veterinary Medical Products undertook their assessment of rBST in 1992-93, further information has indicated that the incidence of rBST-induced mastitis is much higher than employees and professional consultants of Monsanto admit.
Monsanto reported results from eight trials, which the company interpreted as demonstrating that the use of rBST caused no significant increase in mastitis. Sussex University subsequently found out there was an increase of 19 per cent. A later publication from Monsanto covering 15 trials claimed there was still no adverse effect on clinical mastitis or on somatic cell count, whilst the analysis undertaken by Millstone at Sussex University in the U.K. showed that within the 15 trials the use of rBST increased the incidence of clinical mastitis by approximately 39 per cent. This was using figures they obtained from Monsanto.
In 1993, Willeberg, from the University of Copenhagen, who is an epidemiologist, stated that rBST is associated with a 15 to 45 per cent excess incidence of clinical mastitis.
It is very interesting that all, or many, of these worries and doubts concerning BST have been featured in another Canadian paper in 1994. This was a review of bovine somatotropin by Burton and McBride et al published in the Canadian Journal of Animal Science. Four of the five authors, in fact, were Canadian. I will highlight just a few points they make.
We know that IGF-1 is not destroyed by pasteurization, but different claims have been made on the effect of heat on the preparation of infant formulas. Monsanto, in their evidence to you, I believe, said it was destroyed. Dr. Patterson said it was at least 50 per cent destroyed, while Burton and McBride, in their papers, quoted Collier, who is a Monsanto employee, as reporting that 90 per cent was destroyed. One wonders what is the truth.
Burton and McBride, in their paper, went on to say:
Whether re-constitution and consumption of this food product elevates gut luminal concentrations of IGF-1 should be further investigated.
I wonder if this has been looked into any further.
Burton and McBride also suggest that "it could be an oversight for Juskevich and Guyer to suggest that ingested IGF-1 is inactive." They state: "Many more potential effects of ingested IGF-1 on the gastro-intestinal tract need to be explored."
I do not know whether you are aware, but it should be remembered that it was on the work of Juskevich and Guyer that the FDA in fact regarded BST as safe. Burton and McBride go on to say that the majority of the oral challenge studies undertaken were in fact in unpublished and, I suppose, non-peer reviewed papers.
It is worth noting that it was the same Juskevich and Guyer who reported on a study in rats fed IGF-1 at four dose levels. The high and low dose showed changes in heart weight and tibia length. However, because the changes did not occur at medium dosages, the authors concluded:
The findings in the oral group are considered contradictory in terms of effect of IGF-1 on growth indices, and are therefore considered to be "sporadic results".
This dismissal of statistically significant results, as unrelated to treatment, a practice they, in fact, adopt on two other occasions in the same paper, is very questionable. I suggest it would be more prudent to have repeated the experiment when an issue of such importance and widespread concern is at stake.
Going back to the Canadian paper by Burton and McBride, they state under the summary part of the paper that there are many unknowns, and they suggest that further experiments need to be conducted on the possible alteration of other bioactive proteins as well as the effects of the immune function of the gut.
Honourable senators, that any authority could contemplate licensing BST is beyond my understanding, when there is such an incomplete presence of science.
The Chairman: I want to thank you, Mr. Verrall, for your testimony.
Senator Taylor: I want to refer to your second-to-last page, Mr. Verrall. Would it be proper to call you "Dr. Verrall"?
Mr. Verrall: No. I am a simple "Mr."
Senator Taylor: From the studies you have done, you are anything but simple. You are very detailed.
I wanted a little more up-to-date information on your second-to-last page. You stated:
Monsanto reported results from eight trials which the company interpreted as demonstrating that the use of rBST caused no significant increase in mastitis. Sussex University have subsequently found that there was an increase of 19 per cent.
Is that an entirely unrelated study, or did they look at the same eight trials?
Mr. Verrall: There was an article published in Nature in, I believe, 1994. What, in fact, happened here was that the same figures that Monsanto used were given to the people at Sussex University, but they were stopped from publishing it for some time. They were prohibited.
Senator Taylor: Sussex was using the same raw data.
Mr. Verrall: It was provided by Monsanto.
Senator Taylor: Does that also apply to the analysis by Millstone?
Mr. Verrall: Millstone is at Sussex University.
Senator Taylor: Another 15 trials were done, a different set of 15 trials. How would you answer the argument that cartilage being affected in pigs by recombinant somatotropin might be due to the animal growing? I gather that chemicals are given to them to enhance porcine growth rather than have the mother pig give more milk. Cartilage misplacement sounds to me like it was given as a catalyst to get the pig to grow faster.
Mr. Verrall: This trial actually was done in Western Canada.
Senator Taylor: They will do anything out West. That is where I am from.
Mr. Verrall: I am sure that when they reported on this they would not have reported it as such unless they had a control going on at the same time.
Senator Taylor: Was it for the growth of piglets, or was it to give milk?
Mr. Verrall: It was for the growth of the piglets.
Senator Taylor: The last one is a very quick question. I will ask it because I just wonder where you fit in. You are way over in England. This is a fight over rBST. Obviously, Monsanto did not pay your way over. Do you go around the world throwing rocks at Monsanto, or did you just happen to notice us when you were flying over? I am wondering what axe you have to grind.
Mr. Verrall: I have no axe to grind. I retired from the industry in 1986. After 1986, from 1986 to 1996, I expect you noticed a lot of takeovers in the pharmaceutical and chemical industries. Companies were getting bigger and bigger. These companies had been controlled by either veterinary surgeons, pharmaceutical chemists, or medical people, but as they became bigger and bigger that went by the board and, funnily enough, the accountants took over. The moral aspect of things drifted down the list a bit. It worried me.
In 1986, I read a small article about the increase of mastitis from bovine somatotropin written by a man who was subsequently, I think, kicked out of the FDA. He was reinstated by a congressional committee. I cannot remember his name now. That is what set me off. Once I get my teeth in, I am rather like a terrier.
Senator Taylor: You are a one-person United Kingdom Ralph Nader going around the pharmaceutical world.
Senator Hays: I would not mind an elaboration of the statement on page 5 of your written brief, where it says:
The claim is still made by JECFA and Monsanto that IGF-1 is destroyed in the gut, when it is proven that 67 per cent (in milk) can be absorbed from the gut -- and therefore could not have been destroyed, and may act either locally or systemically.
Is IGF-1 taken up in the gut in the normal course from milk of cows that have not been treated with rBST? I am not sure. I read this as saying that, in the normal course, IGF-1 is taken up. If that is taken up in the normal course, then how do they say it is not taken up? I seem to remember talking to a witness in this committee about that, in terms of there being no difference in the amount taken up. I am just not clear on that.
Mr. Verrall: IGF-1, which is produced all over the body in copious amounts, goes down the tract. If it is not with milk, it is digested as a normal protein is digested. The first sign that it was not digested in actual fact probably was drawn to our attention by a man named Mepham in the U.K. in about 1990, when he pointed out that the IGF-1 which was increased in milk may not be destroyed in the gut, as was claimed by the manufacturers, because epidermal growth factor 8, which is another similar protein and another growth factor, was known to be protected by milk and you may get the same protection on IGF-1.
That appeared in the British Medical Journal as a leading article. Very soon after that was a letter in The Lancet from Schofield, who was at Cambridge, and Zumkeller who was, I think, in Great Ormond Street, and Cotterill at St. Bartholomew's, all people well versed in IGF-1, supporting Mepham's hypothesis.
It was very shortly after that that a pediatrician at Thornton Hospital found that if he put IGF-1 in the lining of the gut the result was proliferation of the cells. Alarms bells went off, so to speak, because given the result with the small intestine, if you did that with the large intestine you could perhaps spark off pre-cancerous polyps or something like that and finish up with adenocarcinomas. They were hoping for funding from someone to look into this but it was not forthcoming. The IGF-1 in fact was shown by Zien et al -- the article appeared in an Australian paper -- to be present in the gut because they looked at it as a transport medium -- a method of transporting drugs, the possibility of doing this.
The whole thing was brought to a head around 18 months or two years ago when a Japanese paper came out. They radioactive labelled IGF-1 given by mouth and found that 67 per cent of it was absorbed. Whether it was absorbed as IGF-1 or whether it was absorbed as a conjugated form of IGF-1 or another form of IGF-1 really does not matter at this stage; it was absorbed. It therefore was not destroyed during transit in the gut.
Senator Hays: Let me return to that. I would be less than honest if I did not admit that I do not fully follow you there. I think I have a sense of the issue that has been studied by various scientists. You referred to a Japanese paper which identifies the take-up of 67 per cent using a methodology of radioactive labelling and so on. Did it distinguish between IGF-1 prompted by the use of rBST, for instance, or some artificial hormone, or did it simply identify the IGF-1?
Mr. Verrall: They gave the IGF-1 with casein, milk. It was that which they administered. They measured, obviously.
Senator Hays: The other thing I wanted to ask you about was the higher incidence generally of mastitis in herds that use the hormone. Of course, there has been quite a long experience now of use of rBST in the U.S. dairy industry. Are you drawing on all of the experience there, or have you been selective, if I could put it frankly, in terms of what the experience is over quite a number of years with this higher incidence of mastitis?
Mr. Verrall: Of course, they did a post-PAMP study. They called it monitoring, post-PAMP monitoring.
Senator Hays: I remember the acronym from earlier testimony.
Mr. Verrall: You remember that.
Senator Hays: They are doing that as a matter of course now.
Mr. Verrall: The manufacturers carried out the monitoring. It was not conducted by the FDA. The manufacturers had to pass on their results to the FDA. We have not got access to their figures. I am referring only to trials that we know about that were carried out in the U.K., or figures provided by Monsanto. Some of the figures I quoted, in fact, were from Monsanto scientists themselves: Craven, for example.
Senator Hays: You are relying on the data you presented here. I have not necessarily searched hard for it as to the experience in commercial dairy operations.
Mastitis is obviously going to be a problem in management of cows that are producing more milk than it is in cows producing less milk. Whether they are producing more milk because of their genetic background or through the selection that we have practised to make the dairy industry, particularly in Canada, successful, or whether it is by artificial means, assuming it gave a real uplift in production, would probably be harder to manage than the other because it takes place over time. As you manage those high-producing cows, you learn how to deal with the effects of that in terms of the enormous amount of energy going in and out of these cows to produce this huge amount of butterfat and protein.
I am not surprised that there would be a higher incidence.
Mr. Verrall: Oh, no, but it is not in relation, is it?
Senator Hays: I do not know how shocked or alarmed I should be about it. Can you give me a practical sense of it?
Mr. Verrall: Certainly. If you had a 15 per cent increase in milk yield, you would not be looking for a 30 or 40 per cent increase in mastitis.
Senator Hays: You would learn how to manage your herd better, or you would stop using it if mastitis and lameness and so on gave you a real problem.
This brings me to my last question. Every time I ask this question, I emphasize the fact that we have not authorized BST for use in Canada. It does not appear we are going to. What we have before this committee is many questions being asked that lead us to conclude that the process by which we are making the decision is running into some problems. I see it as a problem of scientists having different points of view and being unable to resolve ways of going beyond those differences. There seem to be some problems in our health protection branch, or at least that is my impression of where we are today in terms of where we have come from and what we have been through.
At some point, a decision must be made, not necessarily on rBST but on hormones or pharmaceuticals or whatever. What is your impression on this in the sense of other jurisdictions? We know the Canadian experience. I tried to describe it. It is not in use in Europe, including Britain. Is it not in use there for the same reason or have they drawn some conclusions?
Mr. Verrall: At the moment, in the U.K., the European Union put a moratorium on it for four years on socio-economic grounds. They were not happy, in fact, at that time. I could, if I have time, quote you chapter and verse where they published a paper saying they were not happy with it. They had not done any research themselves on it; they had accepted the manufacturer's information. The information they had led them to believe that it might be all right if it was properly controlled. That is putting it in a nutshell.
The whole thing is coming to a head now because what you have to look at, I think, is the criteria by which products of biotechnology and genetic engineering are assessed: on the one hand, for a therapeutic purpose and on the other hand, for a non-therapeutic purpose. For a therapeutic purpose, you are treating a condition or a disease. It may be that 4 per cent of the population of anything probably at any one time is being treated over a ten day period. This is under the control of a doctor if it is an individual or a veterinary surgeon if it is an animal. You then have a limited risk.
Where you are talking about yield enhancement, a non-therapeutic application, in the human side with the IGF-1 in milk, if you are going to drink that milk, looking at the Common Market, 280 million people will be drinking the milk over 25 or 30 years with no real controls or no medical control. Therefore, the criteria of safety, quality and efficacy as is used on therapeutic products is, to my way of thinking and to many people's way of thinking, inadequate for the non-therapeutic application.
Senator Whelan: Mr. Verrall, you spoke briefly about the fact that Britain, Europe, Australia, and New Zealand have not allowed the use of this hormone in their countries.
Mr. Verrall: That is right.
Senator Whelan: I think you substantiated it to a certain degree by science. Some people make the accusation that the ban on rBST is a trade restrictionist program. They say that that is why they are not allowing it in those countries. Could you comment on that?
Mr. Verrall: Yes. First of all, I think we should make it plain that we have a surplus of milk to start with, as you do. Second, if you decide to use BST, you will do away with smaller herds; you will get bigger and bigger herds. In the European farming community, we probably have many more small farmers than you do even over here. I think that that was behind the socio-economic moratorium that was put forward.
It is also known, of course, that people do not want to run the risk of drinking milk produced by artificial means. Of course, much more evidence has come to light since 1993 or 1994, when this moratorium was introduced. I think that that is a result of DG-24's two committees that are sitting at the moment, one looking at human health, the other looking at the animal health and welfare aspect of it. They will report to the Agricultural DG, which is DG-6, who will then advise the Council of Ministers, who will then make a decision about whether to accept BST, whether to extend the moratorium, or what to do about it. That will have to be before the end of 1999.
Senator Whelan: We hear a lot about Codex and about JECFA. I have strong feelings that those are probably not the kind of organizations that we want or that we think we should have. Do you have any comment on those organizations? You mentioned them in your presentation today and I gathered that you have some reservations, but maybe I am putting something into your presentation that is not there.
Mr. Verrall: No. I do not think so, sir. I think we share those feelings. Earlier in my presentation, before you arrived, I did say that the principal players in this fiftieth JECFA that has just gone by were all from the U.S. FDA. I asked someone in the past how those committees are chosen, particularly the principal players. I was led to believe that the process goes something like this: "There is a problem. We are going to discuss it. Can we have five volunteers?" I presume that if the right five people volunteer, the others do not do the work and the other five volunteers get away. I do not know, sir, but that is my supposition. I have never attended JECFA. The only Codex Alimentarius committee I have attended was in Paris in September, and I went not as a delegate but as an intruder. It was a general principles committee.
Senator Whelan: Did they let you in as an intruder?
Mr. Verrall: I had to talk my way in, sir. I queued up with the delegations. When I was asked to which delegation I belonged, I said none, that I had come to observe and to listen. I said that I had been told by Brussels that I was entitled so to do. They said that there was no facility, but when I persisted, they let me in.
Senator Whelan: That happens in Canada. I made a request. The provincial ministers and the federal ministers and their officials and all farm organizations were meeting here a week or so ago. I asked if I could go and they told me no. I was not brave enough to be an intruder.
We hear so much talk about the increase in production. You just mentioned, too, that there are going to be big herds and a great increase in production. Are you aware that there is a shortage of dairy products in the United States of America right now? Butter prices in Buffalo and Detroit are anywhere from U.S. $3.25 and $3.50 today. There is a shortage of butter so the price has gone up. I have a strong feeling about this great new rBST. There is talk about the ever-increasing number of dairy farmers in the United States of America using this product. Do you have any idea why there is a shortage of dairy products in the United States?
Mr. Verrall: I have not, sir. It is very interesting, actually, if you look back on the history of this. I believe sales of rBST were registered up to about 1995, but since 1995, no sales figures have been issued by Monsanto. Therefore, it is very hard to tell what the sales are.
Senator Whelan: They keep telling us that there is an ever-increasing number of dairy farmers in the United States using more rBST, yet dairy production goes down. In Canada, we have no shortage of dairy products. We are not using rBST. At least, we are not supposed to be using rBST. I think our dairy production increased 13 per cent last year in Canada.
Our system is a supply management system. We must produce a surplus to guarantee the supply of product at all times. It is dated and it has to be taken off the shelf after the sell-by date. I think in our city we throw away at least 1,000 gallons of milk a week because it is outdated. It is still good but it is outdated. We have no shortage of butter. We have no shortage of any dairy products here in Canada.
What is your production where you are not using rBST in Britain?
Mr. Verrall: We run on a quota basis in the U.K. within the EU. You have a quota of milk and you must not exceed your quota. If you exceed your quota, then you pay a penalty.
Senator Whelan: The British copied that from Canada. We have the same system here. Each province runs their own system for their fluid milk but the overall dairy commission operates from coast to coast. We have brought them up to the same standard. At one time, those who produced milk for the industrial products, the cheeses, were at a lower level but now their standard of production, their health standards and hygienic system are the same. You can interchange the milk back and forth between the two processors.
Are you aware of the stand that the processors have taken in Canada on rBST?
Mr. Verrall: No.
Senator Whelan: They are 100 per cent against rBST. They gave a presentation before our committee. They are scared to death of what could happen to them down the line if there are adverse effects because they are responsible for anything they put in a container and put on the shelf.
Mr. Verrall: Someone did a survey in the U.K. I cannot put the name to it but they said that they reckoned that there would be a drop in the consumption of milk of 11 per cent overnight if rBST goes into the U.K.
Senator Milne: Before I ask you a couple of questions, I should reveal my own personal bias. I have been pretty strongly against this all along. Last night, my youngest son informed me that if this is ever introduced into the milk pool in Canada, not another drop of milk will go into their house, ever. There is a predisposition to breast cancer in his wife's family. They are not even going to think about risking it.
How does the United Kingdom plan to maintain its ban on BST, given that the findings of the Codex Alimentarius Commission increasingly are being used as references in international trade disputes and their findings are based on the conclusions of JECFA, which you have called into question?
Mr. Verrall: The issue of hormones in meat, which came before this BST issue, was the first, if you like, WTO challenge to Europe. They said under the phytosanitary regulations that you need not accept a standard imposed by the international agreement. That is being challenged at the moment within Europe. I think they have 18 months to challenge that their standard of regulation should be different from that which has been laid down.
I presume the same thing would happen with BST, but I do not think they will be challenged on BST because at the moment we do not deny the access of BST products to Europe. To me, that is a great mistake. BST itself cannot be sent but the products of BST milk can. I am quite convinced that there is plenty of cheese made with BST milk going into the U.K. The infant formula food that comes from the United States to the U.K. probably has BST milk in it.
They have said that it is killed by pasteurization. I gave you the different figures. Dr. Patterson said that over 50 per cent of IGF-1 was destroyed. I think Collier said 90 per cent. The person giving evidence to you said 100 per cent. However, what the true value is, I would not know. As Burton and McBride said, "What happens when you reconstitute it?" This thing has been under-researched. There is a lack of science from start to finish. I think it is terribly dangerous.
Senator Milne: That is rather frightening news. I will ask you to make a judgment. Given all that, do you think that perhaps the FDA in the United States made a mistake when they allowed this?
Mr. Verrall: I am sure they did. In my own mind, I have no doubt at all. The work of Juskevich and Guyer, which was fundamental to them passing it, has been challenged. I think it was challenged in a New York court back in 1993. They found papers that were disqualified science papers from the magazine Science.
Senator Milne: Mr. Verrall, I see in your biography that you are a council member of the Food Ethics Council of the U.K. Perhaps you could tell us a bit more about that council.
Mr. Verrall: The council was established about nine months ago because there was widespread public concern over recent developments in the agricultural and food industries, some of which I suppose appeared to offend deeply held ethical principles. Council members were particularly concerned about the relentless pursuit of profit evident in much of the present day agri-business which often appears to pay little attention to adverse effects either on human health or on animal health and welfare. Other concerns include the livelihood of farmers, the natural environment, not least, and the well-being of the less privileged countries. The members of the council have those concerns in common and feel very strongly about them.
It is quite interesting that of the members of the council, I am the only sort of normal person, by which I mean that I am the only "Mr." on the council. There is Professor Philip James, who authored the report on the U.K. government's prospective food standards agency commissioned by the Blair government. He is a leading international expert in human nutrition. He has served on numerous U.K. government and United Nations committees.
Then there is Dr. Ben Mepham, a former research physiologist, who is Director of the Centre for Applied Bioethics at the University of Nottingham. He is a very bright chap.
We have Dr. Peter Lund, who at one time, in fact, worked for an American biotech company before returning to academia. He has a longstanding interest in the ethical issues. He is a lecturer in microbial molecular genetics and cell sciences at the University of Birmingham.
We have Professor Ruth Chadwick, who is a professor of moral philosophy at the University of Central Lancashire. She is not only a philosopher and lawyer but she has a particular interest in ethics and reproductive technologies. She is a director of the International Association of Bioethics.
They are people of quality, people of standing. They are planning to do two papers a year. We are terribly lucky.
There is a trust in the U.K. called the Joseph Rowntree Charitable Trust. We were very anxious when we started this that we did not want any money from industry or government. It was very hard to find out where we would get it. We put the project forward to the Joseph Rowntree Charitable Trust. They came up with the money to finance us for three years. The people have given their time for free but, obviously, when you get something like this and you have working parties and you have to meet and you have reports to issue and that sort of thing, it does cost a lot of money.
Senator Milne: Mr. Verrall, has the Food Ethics Council taken a stand on rBST?
Mr. Verrall: The Food Ethics Council has two projects underway at the moment. One is examining the ethical implications of the use of pharmaceutical agents as growth promoters in agriculture. That includes BST and hormones in meat, as well as antibiotics and the spread of resistance due to those antibiotics used in growth promotion. The result of that study on BST will probably be out in May of next year by the look of it.
The other project is on biotechnology and the production of novel foods. That one is chaired by Ruth Chadwick. That project is still underway. I am a member of that working party, actually.
The Chairman: My understanding is that they cannot test the milk to see whether the hormone has been used in a cow. Is that right?
Mr. Verrall: I do not know whether that is right or wrong, sir. I know there is a company in the U.S. that is said to be developing a test, but I do not know if it has been developed or not.
The Chairman: I believe that one of the scientists who appeared here gave us that information. I see people in the room nodding their heads. I wanted clarification on that situation because there probably is BST milk coming into Canada in very small amounts. You mentioned milk products going into the United Kingdom, possibly from the U.S. You said that you were sure there are products going into the United Kingdom.
Mr. Verrall: Oh, yes.
Senator Stratton: We have debated rBST to the point that, as I have said before, the process that has been established for determining whether this is safe is, I think, underway. We keep getting news of those products that are coming forward. We are just at the leading edge of many more of products coming forward, of course. It is going to be exponential over the next few years.
This is a very emotional issue; however, my concern is that one should avoid becoming emotional when examining the issue. It is emotional to a degree that it really should not be. Products should be properly tested. Products are coming forward in ever-increasing numbers every year. This is not the end. Rather, this is just the beginning of those products. What steps is the British government taking to establish and ensure the safety of those products? If you have knowledge about other governments, we would very much like to hear about that as well.
Mr. Verrall: They are not doing anything concrete at the moment. I think the creation of the proposed food standards agency will help considerably because at the moment the agencies that license products also conduct the surveillance. The idea is that under the food standards agency the two will be separated so that one does not overlap the other. I think that will help a great deal. I think the food standards agency will make suggestions regarding the future of those products and how they should be assessed. The question of need will come into it and, I think, a question of a risk benefit analysis.
Ben Mepham has done an extremely good paper, of which I would be prepared to send you a copy, in which he set up a matrix for a risk benefit analysis. In the case of BST, you would take the cow and the benefits to the cow, the producer and the benefits to the producer and the disadvantages and so on, even to the environment. It sounds hypothetical but there is a very good way of doing a simple analysis on it. I think half of the problem has been that, in the past, not enough attention has been paid to whether the thing is needed in the first place. Consequently, great amounts of money have been spent developing things for which there was no need and for which, in milk, there was a surplus already. I think once the risk benefit analysis comes about, the sooner the better.
Senator Stratton: Is there a surplus of milk in Britain?
Mr. Verrall: Oh, yes.
Senator Stratton: However, is there not a worldwide shortage of milk products.
Mr. Verrall: I do not think so.
Senator Stratton: We have heard reports of an increasing occurrence of mastitis. Say the average for that increase is around 35 per cent. What is the base figure? In a normal herd, what percentage would have a problem with mastitis? Is it 1 per cent or 2 per cent? If it increases by 35 per cent, is that 35 per cent of one cow? That is what I should like to know. Do you know the answer to that?
Mr. Verrall: I do not. I am sorry, sir.
Senator Fairbairn: We have been struggling with this for some time now, not just in this committee but outside of it as well. As Senator Hays said at the beginning, there are the concerns that we have heard from our own people here, the difficulties between the scientists and other parts of the process, and the differences of views between scientists. We have not approved this, however. Every indication that we have received from government spokespeople is that, until the questions are answered, it will not be approved. That is a plus.
For people who are not part of the scientific community -- myself, for example -- it is troubling to hear about the process. One of the great complaints is that, when questions are raised, the process has not seemed to be terribly open to going back to basics. Conclusions are constantly being drawn on the basis of material that comes from elsewhere. For instance, we were told that the United States, in making its decision, based a great deal of the research that it did on material that it received from Monsanto.
We are looking at an international body here and, as Senator Stratton said, we are going to get all sorts of products flying at us from every direction. You have given us a very troubling picture today of JECFA, and I would like to ask you some questions about this. Other countries will be looking at some of these scientific fora in order to draw signals for their own domestic use.
As you have shown, the Codex Alimentarius Commission, of the Joint Expert Committee on Food Additives, when you get right down to it, was not very "joint." That is, it was predominantly American. How many members would be on this committee?
Mr. Verrall: I do not know how many made up the smaller committee. All I know is that the two rapporteurs were both from the FDA. One of the compilers of the report was from the FDA, another one was German.
I submitted a report to JECFA, and I know many other people who have done so. In fact, I have seen some of those other reports. I think the worrying thing to me is that this chronic 90-day toxicological on 30 rats was insufficient, but they did not even acknowledge that it was a matter of concern.
Consider the document that they issued after they had this, and before the full report came out. They included a list of things that organizations and individuals had raised and then, at the back, they said how they had or had not studied them. This chronic toxicological study was not included in the list of things that were raised. It was not in at the end, either. They totally ignored it. I do not see how the rest of the committee or the rest of that JECFA body could have looked at those submissions, because they would have picked out that these things did not appear in the summaries. Yet, they did not appear in the summaries.
Senator Fairbairn: You are from Great Britain. None of the countries in Europe has bought into rBST. Why should we have any confidence in the validity of the conclusions drawn by this body when it does not even have a representative group -- someone from Canada, Britain, France, Italy, or wherever?
Having listened to all of the testimony on this, I really wonder why any of us should have any confidence in this group. Does anybody have enough confidence in this group to allow it to make national decisions based on research that is from somebody else? Is this a relevant body?
Mr. Verrall: I have no confidence in it, none.
Senator Fairbairn: We have heard from you, and we have read your brief. We have also had the experience of listening to producers who have experience with farmers and dairy farmers in the United States. Some of the tales that they have told us are horrific. We hope that this is not crossing our border. The notion that it is going into milk products and food for infants into Europe without labelling, presumably without any kind of cautionary note at all, is frightening.
Mr. Verrall: You could not identify them.
Senator Fairbairn: You cannot do that. Actually, when you think about all that, it seems to me that all the other countries --including Canada, so far -- are being pretty smart by not following the lead of this international body. This leads me to query what that body is there for.
Mr. Verrall: Having read the papers recently, and having seen that Burton and McBride paper again, I look at all the problems they raise, and all the solutions they propose, and yet nothing is done. As far as I can see, nothing resulted from that paper, which is terrible.
I know why this situation exists. In the old days, universities used to receive government grants, and they would get post-graduates to look at things like that. Now, of course, academia is a different kettle of fish. In fact, some chairs in academia are awarded to people who can raise funds from industry, and not for their teaching abilities. This is the problem now.
Previously, there was an opportunity to investigate these things, but that is no longer the case. I do not know who should finance, it but there are queries in that Burton and McBride paper that I still have not seen the answers to. Those questions are plainly there. They put that paper together in 1993, and the questions still have not been answered.
Senator Fairbairn: In all of our countries, we wish to maintain a high degree of professionalism and excellence within our scientific communities. I am sure there are fine researchers in the United States, but the process itself leads one to say that we had better look after our own.
Mr. Verrall: I would just make one comment there. I do not think that the impartiality and independence of scientific debate is a thing of the past, but I would certainly say that it is suspect now. To put it in another way, the white coat of the scientist has become somewhat soiled.
Senator Robichaud: My question is about the last line of your text, where you say, "that any authority could contemplate licensing BST is beyond my understanding, with such incomplete science."
The point that there is a definite lack of data concerning rBST and its effects has already been made by witnesses here. Nobody seems to want to do the kinds of studies that we would need in order to get that data, however. Therefore, the data we have comes from the manufacturer, and it says that it is a good product, that it can be used, and that it has no effect on humans. That data is interpreted to some extent, but, in the end, the fact that some people have said that it is safe to use the product prevails. This lack of data will work against those of us who want to prevent it from being licensed, because they will certainly say you have the data right there, and it proves that this is a good product.
Mr. Verrall: If you cannot disprove it, yes. All the way along, if you look at this data that comes, safety is assumed because of a lack of evidence. It is an assumption of safety, but it does not prove the product to be safe. There is a lovely phrase that says, "the absence of evidence is the evidence of absence". In this case, the absence of side effects, because that is quite frequently what is done now.
Senator Robichaud: It is really just a matter of time. You say that some products that are being imported into Britain are themselves the product of rBST milk. Your moratorium was for socio-economic reasons.
Mr. Verrall: That was in 1993, but I have no doubt in my own mind of the results of the deliberations performed by DG-24, which is the consumer protection and the risk analysis unit. They have done a big revamp quite recently in the EU. The DG 24, which is the consumer protection, has been reinforced considerably. It is a very excellent DG now. It is very open and transparent, and this is what we must get. This is one of my quibbles about JECFA. It is not open and transparent. You have to fight hard to get any information from JECFA.
When JECFA brought out its summary and conclusions document in March of this year, I rang up the secretary in Geneva and asked when we could expect to get the final report. I did this because they a part in this summary and conclusions document that said we should not discuss it until we received the full report, and that this prohibition was not open for discussion.
The secretary in Geneva told me that the document I wanted -- the one with the details -- would be out in October, with any luck. He also said that the full report would not be out for one year. When I asked why, he said, "All the t's have to be crossed and the i's dotted," and I said, "Yes, but not twice over."
I am told that JECFA, in fact, does not have the finance behind it, unlike the Codex Alimentarius committees like General Principles or the Residues Committee. This is why you get the reports from the Codex Alimentarius committees rather quickly rather JECFA. The JECFA one, however, is produced as and when they have time. That is what I am told, but it is not satisfactory.
Senator Robichaud: We seem to have had some problems getting all the information here, too. It has finally made its way to us. This is just to tell you that you are not the only one. The fact that this information was not forthcoming has raised serious concerns. We certainly want to look deeply into the matter, but there is a lack of data. The reasoning seems to be that if you cannot prove it is not right, then it must be good. Eventually, it will make its way, and people will use it.
Mr. Verrall: I do not know. It is a major problem. Unfortunately, too, academia has become more and more reliant on funding from industry. You do not bite the hand that feeds you.
Senator Robichaud: Absolutely.
Senator Sparrow: Reference is continually made to the idea that it has not proved to be safe. Is there any way, in anything, at any time, that one can prove that something is safe?
Mr. Verrall: Last week the chief medical officer in England appeared before the inquiry that is looking into mad cow disease there. He had been accused of saying that the meat was safe to eat. He said at that time he thought it was safe to eat. He said, "If I say a driver is a safe driver, then he may be a safe driver, but there may be an occasion on which he is not so safe." Therefore, you cannot guarantee that anything is 100 per cent safe.
Is "safe" not dependent on what you are using the thing for, and for long you are using it for? Imagine that someone is dying of carcinoma of the stomach, and that he or she could have an anti-emetic to stop the vomiting, but that that anti-emetic would cause that person to have blood dyscrasia over six months. If that person were suffering from terminal carcinoma of the stomach, and would die in weeks anyway, it would not matter. In that case, the anti-emetic would be deemed to be safe.
Senator Sparrow: At the given time.
Mr. Verrall: At the given time, yes. With all these non-therapeutic yield enhancement products, however, you are looking at very long-term use. As I pointed out earlier, the criteria have to be different, and someone has to establish those different criteria.
That is one of the things we will try to do on this Food Ethics Council. Our first report will come out next May, and it will include suggestions on how we should approach this. I would also like to see a similar thing happen if there is a food ethics council in Canada. I think it will come. I think it will be a sort of an international situation.
Senator Sparrow: What we have to do is determine if a product is unsafe. Is that what we are trying to do?
Mr. Verrall: Yes.
Senator Sparrow: To prove that it is unsafe, not to prove that it is safe. We keep referring to "proving it safe".
Mr. Verrall: Where is the facility to prove it is unsafe? If a company wants to market a product, then it is up to that company to prove that it is as safe as it can possibly be, in my book.
Senator Sparrow: They have not found it to be unsafe. There is a difference.
Mr. Verrall: They have not found is unsafe, providing they have done all the tests that are considered to be pertinent to that product.
Senator Robichaud: That has not been done in this case.
Mr. Verrall: Those tests have not been done.
Senator Sparrow: You cannot detect BST in milk products, is that correct?
Mr. Verrall: Not that I am aware of, as I said earlier. I believe that someone is developing something to detect it in those products.
Senator Sparrow: How do you detect it in the animal then?
Mr. Verrall: I do not know.
Senator Sparrow: You do not know if it is detectable in the animal?
Mr. Verrall: I honestly do not know.
Senator Sparrow: Do we know?
The Chairman: I do not. I see a hand raised in the audience.
Mr. Richard Lloyd, National Farmers Union: If I may, it is my understanding that a blood test will detect it in an animal. I have been at several meetings discussing the development of a test for milk. The science was quite difficult, but I believe that it can be done scientifically. I just do not want to take up any more time explaining it unless I am asked to.
The Chairman: You, yourself, are not a scientist?
Mr. Lloyd: No.
The Chairman: Does the witness have anything further to say on this?
Mr. Verrall: No, sir.
Senator Rossiter: Why have they not come to some conclusion about the increase of mastitis? Is it not obvious? Monsanto said the use of rBST caused no significant increase in mastitis, but Sussex University said there was an increase of 19 per cent. Later, after 15 trials, Monsanto claimed that there was no adverse effect, while Sussex University showed that, within 15 trials, use of rBST increased the incidence of mastitis by 39 per cent.
Mr. Verrall: It was using the same figures, too. It was the way that the statistics were done in the epidemiological study. In actual fact, I believe a lot more statistics have been put out on the incidence of mastitis. If one could get those, and if one could have the university do exactly the same thing with them as they did on these two studies, the answer would probably be the same. I think it is a matter of being able to almost distort statistics.
Senator Rossiter: Are these studies in the hands of the companies and the industry?
Mr. Verrall: The Sussex ones were not, no.
Senator Rossiter: No, I mean the studies that you said were apart from the two that you mentioned.
Mr. Verrall: I have been told that such studies exist. How you would get them, I do not know. If only one could channel them into the universities and get it done, it would be a very interesting exercise.
Senator Rossiter: Do you think they are continuing to do studies on mastitis as rBST moves into longer-term use?
Mr. Verrall: I do not know. It is a closed shop on what is happening in the U.S. Nothing is published.
The Chairman: Do you have a closing statement or remarks that you would like to make?
Mr. Verrall: I am very grateful that you asked me here. I have enjoyed this afternoon, as much as one can enjoy these occasions. Thank you very much for being so helpful to me.
The Chairman: We, as a committee, want to thank you for appearing and for enlightening us on the international situation regarding BST.
The committee adjourned.