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Proceedings of the Standing Senate Committee on
Agriculture and Forestry

Issue 17 - Evidence


OTTAWA, Thursday, June 4, 1998

The Standing Senate Committee on Agriculture and Forestry met this day at 9:05 a.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, the order of business today is BST and its effects on the human and animal health safety aspect. We have representatives of Monsanto Company with us today. Mr. Ray Mowling, the Vice-President, is going to introduce his people and give us a short statement.

Mr. Ray Mowling, Vice-President, Government and Public Affairs, Monsanto Company: Rather than introduce my colleagues, I would prefer to have them introduce themselves.

Mr. David Kowalczyk, Director, Regulatory Affairs, Monsanto Company: As a Director of Regulatory Affairs for Monsanto Company, I handle the animal health product approvals. I am a veterinarian by training. I joined Monsanto 13 years ago and have been involved with all the registration activities across the world for BST, in particular. I manage the approval in the U.S. I am involved very heavily in the positive scientific opinion in the European community, and I have been involved since 1985 with the activities here with the Bureau of Veterinary Drugs in Canada.

Mr. Robert Bell, Veterinarian, St. Mary's Veterinary Clinic: I am a veterinary practitioner from Southwestern Ontario. I have had 20 years in bovine practice, and have seen the dairy industry from both sides because I was a member of the board of directors of All Foods prior to its sale in 1997. My emphasis is on farm profitability. I work considerably on farm financial structure and the expansion process for the Canadian dairy industry.

Mr. Robert J. Collier, Chief Dairy Scientist, Senior Fellow, Monsanto Company: I am senior fellow and chief dairy scientist for Monsanto Company. I have been involved with the safety studies required for the U.S. and European technical approvals.

Mr. Mowling: I am a Vice-President with Monsanto in Canada, with principal accountability in the areas of public affairs, government relations, and business growth. I have been with my company for almost 28 years in Canada. I have been involved in this particular file for the last eight years or so, and I was a member of the government BST task force that was set up in 1994.

The four of us represent the ability to address some of the issues that the committee have laid out for us. If it is acceptable, I would like to table a short statement, which I hope all members of the committee have now, with some attachments. If you will bear with me, I would like to go through the statement now. Rob Bell has a short statement, as well.

The statement is laid out here. It is intended to explain what BST is and how it works, and to inform the committee on the diligence being exercised by the manufacturer and Canadian and international regulators and reviewers who are asking questions and investigating leading knowledge.

This statement is intended to share some insight into the enormous body of resource already completed on BST, showing that it includes exhaustive scientific studies that address long-term risks to human health, and overwhelmingly points to BST's safety for humans, as well as animals.

Finally, this statement is intended to explain why the current BST regulatory and scientific assessment process underway in Canada must be allowed to continue unimpeded until it reaches an independent science-based conclusion.

First, what is BST and how does it work? BST, or bovine somatotropin, is a naturally occurring protein hormone that is produced by cows and stimulates milk production in lactating cows. Cows supplemented with BST produce more milk and the natural level of BST in their milk remains unchanged. Supplementing cows with BST does not change the milk those cows produce. Recombinant DNA technology allows us to reproduce naturally occurring proteins such as BST safely and efficiently.

Monsanto submitted BST for registration in Canada in 1990. BST is registered and is commercially available in 13 countries at present.

What do Canadian human health experts say about BST? These are some of the quotes I have included. "Large scale trials in Canada, as well as in the U.S., have repeatedly shown that the bovine somatotropin increases lactation among dairy herds and is not associated with adverse human effects." This is a statement by the Canadian Paediatric Society.

"There is no evidence that the use of bovine somatotropin in dairy cattle constitutes any risk to human health." This is from the Canadian Medical Association Scientific Panel.

(BST) is not considered a health risk to the consumer based upon the compelling evidence that:

1) the nutrient composition of milk is within the usual range of variation of that of untreated cows;

2) rBST, or its mediator (IGF-1), present in milk, are protein hormones with no oral biological activity. Their trace amounts are rendered inactive in the gut through pasteurization or retort processing of infant formulas;

3) rBST has no biological effect in humans; and

4) milk from rBST-supplemented cows is as nutritionally complete as milk from unsupplemented animals.

This is from the McGill Nutrition and Food Science Centre, Royal Victoria Hospital.

The public can be reassured that BST supplementation of dairy cows offers an opportunity to increase milk production at a lower cost without any health risks to the consumer. This is written by the Program in Food Safety, Department of Nutritional Sciences, the University of Toronto.

BST exerts its milk-producing effects by triggering the synthesis of a protein known as insulin-like growth factor-1 (IGF-1). There is no question that some BST and IGF-1, in both treated and untreated cows, does pass into the milk. However, the amount of these substances in the milk of treated cows is within the normal range of variation found in the milk of untreated animals. Furthermore, both hormones are inactive in humans when ingested, and are broken down in the digestive tract like any other protein. The nutritional value of the milk is not affected by BST, and there is no reason to suspect it will trigger an increase in allergic reactions.

These are from Drs. Harpp and Schwarcz at McGill University.

I have one final quotation in this section: "We've reviewed the human safety aspect, and we have no concern with regard to the human consumption of milk from treated cows. It's been approved by the U.S. Food and Drug Administration and has been sold there for three years. There has been a post-approval monitoring program and in November there was an advisory committee group who met and further indicated that there were no adverse effects from the use of the drug." This is a quote from Donald Landry, Acting Director of Health Canada's Bureau of Veterinary Drugs, in February, 1997.

What did international human experts say about BST? Senator Whelan may be familiar with the first organization I cite, the Joint FAO/WHO Committee on Food Additives (JECFA): "JECFA concluded in March of 1998, after reviewing `new evidence', that there are no food safety or health concerns related to BST residues in products such as milk and meat from treated animals."

"FDA scientists have determined that milk and meat from rBGH-treated animals are safe for human consumption." This quote is from the U.S. Food and Drug Administration.

"In the unanimous judgement of the panel -- the composition and nutritional value of milk from rBST-treated cows is essentially the same as milk from untreated cows. As currently used in the United States, meat and milk from rBST-treated cows are as safe as those from untreated cows." This is the National Institutes of Health.

"The FDA has answered all questions and concerns about the safety of milk from BST-supplemented cows for human consumption." This is from the Journal of the American Medical Association.

"This report concludes that, based on today's research findings, BST poses no additional risk to consumers." This is from the Congressional Office of Technology Assessment.

What do animal health experts say about BST? These quotes are from statements made by some animal health organizations: "The use of BST in dairy cattle can increase productivity by increasing milk production... good management and quality environment are essential to obtain an optimal response." This is from the Quebec Veterinary Practitioners Association.

"BST is a protein hormone that has been shown to increase milk production in dairy cows. Extensive scientific research has shown that milk and milk products from supplemented cows are identical in content and quality to those from unsupplemented cows." This is from the Alberta Veterinary Medical Association.

"The Canadian Veterinary Medical Association is of the view that the use of Bovine Somatotropin (BST) in cows to increase milk production poses no threat to human safety." This is the CVMA.

"The use of recombinantly produced bovine somatotropin (rBST) is safe for dairy cattle and has no effect on humans. Cows which are supplemented with rBST produce milk which is identical in content and quality to that from unsupplemented cows." This is from the Western Canadian Association of Bovine Practitioners.

Other organizations that have also confirmed the human and animal safety of BST are the Quebec Veterinary Medical Association, the Ontario Association of Bovine Practitioners, and the Quebec Association of Animal Production Agrologists.

My next topic is our commitment to post-approval monitoring. We understand and strongly agree with this Senate committee's commitment to ensuring that diligence is exercised to continue monitoring in order to ensure the safety of any newly registered products that have an impact on human and animal health.

Monsanto's commitment to take responsibility for its products, to be vigilant, and to share new findings with reviewers, demonstrate that we share the statements made by Senator Keon on May 5, that, it is the job of medical science to continually ask questions and to investigate, leading to knowledge which, over time, alters assumptions and conclusions. To that end, we are committed to on-going monitoring. To illustrate this commitment, I have listed some key findings from our Post-Approval Monitoring Program (PAMP) study, which is one of the attachments. This explains the post-market surveillance and tracking results provided to the FDA in the U.S.

In the U.S., BST was commercially introduced more than four years ago. Monsanto initiated a PAMP in close cooperation with the U.S. FDA. The objectives were to collect additional information about BST supplementation in on-farm settings, evaluate the adequacy of established product-use instructions, and determine whether the product affects the quality or safety of milk. PAMP was voluntarily conducted and developed by Monsanto, with final review from the FDA.

Initiated in 1993, PAMP consisted of the following three components: an Adverse Drug Experience (ADE) reporting system, analysis of state antibiotic drug residue data, and a health evaluation of 28 commercial dairy herds.

Results of this unprecedented two-year PAMP study for BST recently earned unanimous support from the FDA Veterinary Medical Advisory Committee (VMAC). The monitoring program confirms the safety of rBST for cows and the safety of the milk supply from cows supplemented with rBST.

In addition, Monsanto evaluated IGF-1 levels in shelf milk from several retail stores in the U.S. The results showed no difference in the IGF-1 concentrations between labelled milk -- that certified to be derived from cows not treated with rBST -- and unlabelled milk. Use in 13 countries continues to substantiate these findings.

Next, I would like to discuss the critical path of BST in the Canadian review process. It is our intent to continue to encourage and support a review that is based on strong scientific evidence and the weight of scientific findings. Since our submission of BST to the BVD for review and regulatory approval in 1990, we have encouraged Health Canada and regulators to look at the existing broad body of knowledge and the extensive studies available. We have been pro-active in informing them of any new findings.

A brief overview demonstrates the extent of the body of research knowledge available to the BVD reviewers, more than for any other product. Over 2,000 independent scientific studies have been conducted. Within the human health spectrum, they cover IGF-1, antibiotic resistance, BST levels, cancer, and breast milk. From the animal health perspective, they include cow udder health, cow burn-out, cow life expectancy, reproductive capacity, and health of the legs and feet. Milk quality studies include composition and wholesomeness, nutritional value and, of course, allergenicity.

The chronology of key events in the Canadian review process include, from 1987 to 1990, the preparation of the new product submission. We worked with the regulators on defining what would be required. In fact, that is laid out in section 2 of the BST Task Force Report. Saul Gunner laid that out in section 2 of that report. It lists the kinds of things that were required.

In 1990, we made our submission. In 1990, the regulators confirmed the human safety of BST for the first time here. From 1991 to 1995, human health experts, including the CMA and the Canadian Paediatric Society, confirmed the human science behind BST.

In February 1994, sales began in the U.S. In September 1994, Agriculture and Agri-Food Canada announced the task force.

In May 1995, the task force reported.

In November 1996, VMAC of the FDA unanimously endorsed the results of the PAMP, and results of the PAMP in the U.S. were provided to Health Canada at that time.

In March of this year, upon review of the full body of knowledge and research on BST, the JECFA, confirmed that there are no food safety or health concerns related to BST.

Finally, I will address why the science-based regulatory process must be allowed to continue until it reaches a science-based conclusion. Sound, extensive, in-depth research into the safety and efficacies of BST must be the basis for the decisions to be made by Canadian reviewers in deciding whether they will approve BST for use and sale in Canada. Should the product be registered, farmers and veterinarians can clearly voice their thoughts by either buying it or not. If there is no demand, the product will not be used. Any other approach may set an unacceptable precedent, implying that approval of a human or animal product is not based on scientific findings.

I have listed the attachments, Mr. Chairman. The science article and one other piece are currently being run off, but the rest are attached to the statement.

Mr. Bell: As I stated in the introductions, I am a veterinarian from Southwestern Ontario. The majority of my time is now spent on farm expansion, farm profitability, working for many of the financial institutions in this country on setting up farms in profitable fashions. All my work is in the dairy area. This led me to some work with Monsanto because the questions with this product were: Was there a use? Was there a need for it in the Canadian marketplace? Would it be useful to Canadian farmers?

We do a lot of economic modelling of Canadian dairy systems, and it works well in this situation. I guess any business in the 1990s that is offered a lower cost of production or a chance to cost-effectively increase revenue without capital expenditures is a godsend. That is an advantage for smaller dairy farms because most of the technologies that lower cost in this day and age on farms require large capital expenditures. This product does not require that. It gives smaller farms the same advantages as larger farms.

In addition, if this product comes to the marketplace and goes through the review process in Canada, it will be a prescription product. That means that it will be used in close conjunction with the producer and the veterinarian.

How it works is really very simple. It increases dry matter intake and consequently lowers maintenance costs. In this business, we mainly worry about how much cows eat. Feed costs to the dairy industry account for 40 to 50 per cent of the cost production. Any time you can affect those large numbers, you definitely increase farm profitability. There is no question about it.

It has an added advantage. We have moved to a daily quota system in Canada. That means farmers produce milk based on a daily quota allotment. They are allowed 25 days extra if they fall behind, but products like this allow them to effectively stay within their production range, without going out and either buying cows or putting money into large capital expansions.

The other issue that I think will become important is the environmental issue. Every time we can increase the efficiency of cows, we have a decreased environmental impact. There is no question that there is less fecal and urine output from these cows.

Finally, if we are heading into another round of GATT negotiations in 1999, and no one in this room can tell where that is going to lead us, but generally speaking, we must be competitive in all areas. We are starting to move into some export markets in the Canadian dairy industry. Cost is important to move into those markets. I can tell you that from my experience on the All Foods board of directors. The cost of retrieving the raw product is important for processors.

As for the question of demand, frankly, the majority of my clients would like the opportunity to use this product.

I will open up the floor for questions and answers, along with the rest of the group.

Senator Spivak: Mr. Chairman, I have a question of clarification. Mr. Bell, what is your relationship with Monsanto?

Mr. Bell: I was hired as a consultant to look at the economic impact of BST, originally through some modelling processes in Canada.

The Chairman: What percentage of producers in the U.S. use this product?

Mr. Kowalczyk: I think right now about one-quarter of the producers in the U.S. use the product. Our customers' cows now represent about one-quarter of the entire dairy herd population of the United States.

The Chairman: Is it used in Europe at all?

Mr. Kowalczyk: No, it is not used, even though we have full scientific approval in Europe. There is a current moratorium in place, but we are still pursuing approval there.

The Chairman: Is the U.S. the only country that uses it?

Mr. Kowalczyk: There are about 15 countries now using the product. Some of these are the U.S., Mexico, Brazil, South Africa.

Mr. Collier: Israel approved it this past week.

Mr. Mowling: There is a list here. It is actually headed "Posilac," which is the brand name in the U.S. It is called Posilac in other countries, and it lists the countries there. South Africa was the first country to use it, ten years ago, I think.

Senator Spivak: Would you agree with labelling the rBST-treated milk as opposed to milk which has no rBST? What is your position on that?

Mr. Collier: In the U.S., we have always recommended that we follow the federal guidelines. I am assuming that we would follow the same guidelines here in Canada.

Senator Spivak: What is your position on labelling versus not labelling? Forget the federal guidelines for the moment.

Mr. Collier: We have always supported the proper labelling of milk, including the health information. The information cannot be misleading to the public.

Senator Spivak: Thus, rBST would be listed. I am concerned about the IGF-1. Please bear with me. This is a difficult area so I have written notes. The U.S. National Institutes of Health in 1991 said that milk from test herds was safe for human consumption but they also said that more study was needed to determine the acute and chronic effects.

In 1991, it was the same thing. An expert committee of the American Medical Association stated that further studies will be needed.

Since then, science has made several important discoveries. A study published in 1995 provided clear evidence that IGF-1 survives digestion when casein, a component of milk, is present. The finding was confirmed by a Japanese study published late last year which reported that 67 per cent of IGF-1 was biologically available when casein protected it. The earlier studies had used IGF-1 without other substances.

A 1995 National Institutes of Health conference on the IGF system concluded that IGFs are important cancer-causing substances that may enhance "tumour cell formation growth and even metastasis."

Studies published in January and May from Harvard and McGill found links between elevated blood levels of IGF-1 and prostate and breast cancers.

In February, Monsanto presented new information on levels of IGF-1 and retail milk in the United States to JECFA, and the company's results showed no difference between labelled (non-rBST) and unlabelled milk. But the report did not specify how much of the unlabelled milk came from cows receiving rBST.

Mr. Collier: There are several components to that question, and then I would like to walk through that argument with you.

Senator Spivak: Is it correct that a high percentage of the unlabelled samples came from Wisconsin, which has the lowest rBST use in the country? I wonder if you could give us more information about that report and the data on unlabelled milk, which was not in the report.

Mr. Collier: You had several questions in your question, so I am going to start at the beginning and go through the whole thing. Number one, IGF-1 is a normal component of the digestive tract. There have been several new studies, especially in the last five years, that show that all the digestive tract secretions, including saliva, gastric juice and pancreatic fluids, which are released into the digestive tract, contain IGF-1. Every meal we eat contains it. In fact, the digestive tract secretions have much higher IGF-1 concentrations than milk. The fact that there is IGF-1 in milk, that you consume it, is not a novelty. It is a normal component of the digestive tract.

The second question relates to the digestion issue. I think you had slightly misinterpreted the paper you described.

Senator Spivak: That is quite possible.

Mr. Collier: If casein is present, it slows down the rate of digestion, but it does not prevent digestion. When the recent FAO committee reviewed that data, they concluded, after two hours in the digestive tract, less than 5 per cent of any injected IGF-1 that is present with casein would still be present. In other words, it is not as though the IGF-1 in milk magically escapes digestion because casein is present. It merely slows down the rate at which it is being digested. It still gets digested.

There have been three studies now where they have used massive doses of IGF-1 in calves, pigs, and rats to show that they cannot demonstrate a biological response in the animals or the blood concentration of IGF-1 with several days of dosing, even in newborn animals.

This is the argument. First you have milk IGF-1, and the majority of the data that has been gathered on milk IGF-1 in cows treated with somatotropin showed no change. Even in those studies that show a slight increase, those values are within the range of normal IGF-1 values found in cow's milk and in bulk tanks from farms not utilizing BST. That range is 1 to 30 nanograms per milk. There are no studies showing that the concentration of IGF-1 in cow's milk exceeds the normal range.

Second, in the gut, an alteration in digestion must occur if that increase in IGF-1 is going to translate into an increase in blood IGF-1.

From a safety standpoint, the studies that have been carried out show quite clearly that IGF-1 is digested. It does not escape. In fact, if all the IGF-1 in your gut were to get out into the bloodstream, you might see a detectable change of blood IGF-1, but if you just took the milk IGF-1, and if all of that escaped digestion, there is still so much IGF-1 in human circulation in the blood that you cannot change the concentration.

This argument that it escapes digestion has to be true. Then you must have a change in blood concentration. In reality, these three things are independent of each other when you evaluate the factor's safety. Whether or not there is a change in IGF-1 is independent of the rate of digestion in the stomach or the gut, and is independent of the blood concentration. But, in fact, for this safety concern to be true, all these things have to be affected. You must have an increase in IGF-1; it has to escape digestion; and you have to have a resulting increase in blood concentration.

If the IGF-1 concentration in milk escaped digestion, and all of it got into the blood stream, it would represent less than 0.8 per cent of the blood concentration of IGF-1. Therefore, there is no basis for an argument that says that because you have an increase in IGF-1, you have a resulting safety issue in humans.

Senator Spivak: You are dismissing all these studies.

Mr. Collier: I am not dismissing them. I am using those studies to show that safety has several levels.

Senator Spivak: There is a concern. I want to pass on from that. I accept what you are saying. Basically, you are disputing the contention of some of these scientific groups that further long-term studies will be needed. You are saying that they are not necessary. I wish a clarification of your position.

Mr. Collier: The position is quite clear. Studies have been carried out since the National Institutes of Health review. Studies will continue to be carried out. You cannot stop the march of science.

Senator Spivak: I have your point. I wanted to talk about antibiotic residues, but others also have questions for you.

Senator Whelan: Mr. Chairman, I wish to make a statement first. For one thing, there was never a shortage of milk in Canada, even before I became Minister of Agriculture. We had warehouses full of surplus dairy products. When we are talking about efficiency and increased production, the big problem I had was controlling production because the farmers would wildly produce anything. The best business to be in was the cold storage business. If you provide farmers with a little bit of an incentive, away they go, producing.

Some people have said that I am against biotechnology. I challenge anyone who has made that statement. When I was the Minister of Agriculture, no one conducted more research in the history of Canadian agriculture than we did. We built the biggest research branch of any branch of government. We did more for veterinary medicine than any ministry had done before, too. I was at one time an honourary full-time member of the Canadian Veterinary Medical Association for my contribution to the organization.

We have all kinds of evidence from scientists who have beliefs which differ from yours. They can be documented, just as your evidence is documented.

One scientist recently told me that no scientist can guarantee the safety of almost any product. They will use the evidence that is presented, but they cannot really say that this is 100 per cent safe for use.

Mr. Collier: Senator, that is why they talk in terms of acceptable risk. I agree with you, there is no such thing as a 100-per-cent guarantee in life. Regulators have to look at it from the standpoint of the magnitude of risk that is involved. When it comes to somatotropin, the United Nations has gone through this process twice. They cannot assess a level. The safety margin is so high, they have not even established the minimum residue level for this compound.

Senator Whelan: One of the things that we talk about is labelling. Senator Spivak mentioned the topic of labelling. Some recent projections indicated that rBST would increase milk production by as much as 40 per cent in a cow. I understand that we have never reached that level of production by the herds that have been involved because no two cows react the same way to the injection. This holds true for humans, as well. No two humans react in the same way if you give them an injection because no two chemical systems, animal or human, are exactly the same.

Mr. Collier: You are exactly right. Because of that variability among animals, we have a distribution, a range, in the response that cows have been shown to produce. The average response is around four to five kilos per day, although the range can be quite large.

Senator Whelan: We know that there is a large variation in milk production. I do not pretend to be completely familiar with every one of the countries which you have listed as using rBST. However, when I see some of the countries on the list, I am in a state of shock because I know about their ability. I know about the production facilities they have. I used to know what the average production of dairy cattle was in almost every country. I have strong concerns in this area.

Mr. Collier: Israel has the highest average milk production in the world for its national dairy herd, and the United States is not too bad, either.

Senator Whelan: I know that Israel got their genetic breeding from Canada back in 1935. With genetic breeding and good nutrition, we helped them produce one of the champion herds of the world. I am very much aware that the genetic breeding came from Canada, too, not from the U.S.

Mr. Collier: We use Canadian genetics in the U.S., as well, senator.

The Chairman: I know you do. We had agreements with all of the countries. We signed agreements with Israel to exchange our scientists to work back and forth together.

The president of a pharmaceutical company, Ace Aldo Baumgartner, said that the pharmaceutical industry is interested in safety. The proof is that his company discontinued late development of two products because of side effects. Posilac has over twenty possible side effects listed on the bottle.

How many side effects do you require before you question the safety of your product?

Mr. Collier: First, regulatory agencies evaluate the safety of a product, not the companies, in our experience.

Mr. Kowalczyk: You have obviously looked at our label. The Aspirin label warns of probably 50 things associated with it. Our labels almost always read "may occur" or "may increase the risk." It is very important to note the wording.

We have looked at our post-approval monitoring program, and we had the most extensive adverse drug experience reporting system of any product. We have the advantage in the U.S. of direct distribution to every dairy farmer in the U.S. We continually call the customer. We have contact with, and get input from, customers on any kind of experience they have had. We have not uncovered anything unusual in our product that does not normally occur in any kind of dairy herd. Everything occurs with the same incidence in cows not supplemented with BST. We receive almost no reports or complaints of Posilac being associated with an increase of something like mastitis, which is probably of most concern to dairy farmers. That has an impact on milk production.

Senator Whelan: We have heard presentations from highly qualified people, scientists from the United States of America, Europe and England, expressing deep concern. Their arguments are just as firm-sounding as the ones that you have made here today.

How can we be sure that increased levels of the hormone IGF-1 in rBST milk will not cause harm to milk drinkers, whether they are infants, children, growing teenagers, pregnant women or the elderly? You cannot guarantee that.

Mr. Kowalczyk: Every product has its critics. Over 30 countries have approved it as far as food safety, and this is unusual. Every regulatory agency and every scientific body in the world that has reviewed BST has found it to be safe. I am speaking of associations like the American Medical Association and the Canadian Medical Association. No scientific body has come to a different conclusion.

Mr. Collier: When independent panels review the safety factor, their collective wisdom is considered to bear more weight than a single person's point of view. Monsanto's point of view is not considered when these panels such as the National Institutes of Health or the FAO committee from the UN have evaluated safety. These are all independent reviewers. They call in experts and together they deliberate because, as you point out, it is a complex issue.

Senator Spivak: Both the American Medical Association and the U.S. National Institutes of Health called for further studies.

Mr. Collier: Those studies have been carried out. We have continually carried out studies on IGF-1.

Mr. Kowalczyk: It is important that they concluded that the milk and meat from cows that had been supplemented with rBST is safe.

Senator Whelan: You are not going to impress me by quoting WHO or FAO. I was associated with them for 12 years and I know how they operate. They operate on grants and their decisions sometimes depend on who pays their bills. As far as that goes, I have as much respect for some of their decisions as hell would have for a snowball. Do not try to impress me with them because I know how they work. Do not try to impress me, if you are going to go that far, with Codex because I know how they work. The big companies sit behind them and tell them what to do.

They just had a meeting here in Canada. Canada voted with the United States. I asked them yesterday: "Why did you vote with the United States? Who authorized you? Was it Parliament?" Parliament never had a damn thing to do with it. All these things go on in this way.

Mr. Kowalczyk: I share your concern about Codex itself, but the expert committee is a very separate group that is composed of regulatory scientists from around the world. For example, this last JECFA, which convened in February, is composed of approximately 40 regulatory scientists from around the world, including Canada. That is different from looking at Codex itself.

Senator Whelan: Look at two of the things that have been passed historically: thalidomide and implants. I could go on and name several. I have a list in my briefing book. Those were all guaranteed to be safe, just as you are saying to us today about rBST, and look what happened.

I said this at the beginning: No scientist can guarantee that this product is safe. I am also suspicious of veterinarians because they are being paid a good salary by Monsanto to implant cows in these small herds. We know that we built herds that are the envy of the world by good genetic breeding, by moving faster than any other country with artificial insemination (AI), with embryo transplants and these kinds of things, to improve a herd. You are the big benefactors of this. If you issue a prescription, you are going to get a fee for a prescription, too. You are different from any other druggist that I know if you do not.

Mr. Bell: I would like to respond to that. In fact, by law we are not allowed to charge for prescriptions.

Mr. Whelan: Is that the case for every province?

Mr. Bell: I cannot answer for the other provinces.

First of all, I would like to acknowledge what you have done for Canadian agriculture, Senator Whelan. The Canadian veterinary profession has witnessed the phenomenon. I would like to say exactly what you have said, that we have bred a tremendous dairy herd in this country. We have tremendous management practices. This product works in such situations. There is no question about it.

With poor management practices, you get no response from this product. Under good management practices, you do. I think that is important.

This will be available to farmers by prescription from a veterinarian, so its use should be controlled and monitored.

There is a variation in response. The percentage response depends on where .0 is when you are starting.

Senator Spivak: It does not increase the quality of the milk.

Mr. Bell: No, but it lowers the cost of production.

Senator Whelan: I am sure that you realize this is only a preliminary meeting. We will meet later this year before we finish and will probably have several meetings with you before we conclude. The veterinarians make money. A cow eats more, too, does it not?

Mr. Bell: Correct.

Senator Whelan: The veterinarians, Monsanto, and the feed companies make money. Some agricultural economists have said that what the producer makes is small in comparison to what they make. As you say, if management is not good, it is not going to be a paying proposition for those producers.

Mr. Bell: They will not continue to use the product very long. We monitor everything that goes on now in the farm, Senator Whelan, especially the economic benefit. A lot of homegrown forages are increased with a good cost of production. These guys can make money using this product. They can lower their cost of production.

I realize, under a quota system, that we do not need more milk. Nobody in this room is here to argue that we cannot produce milk more profitably.

Senator Whelan: Was Monsanto ever reprimanded for violating the law before your product was approved in the United States of America? Were they ever reprimanded, ever fined, ever charged?

Mr. Kowalczyk: No, we were never fined or charged.

Senator Whelan: Were you ever reprimanded?

Mr. Kowalczyk: As with all the companies, and actually the CVM, that were pursuing approval for BST, in about 1991 we were asked to limit the amount of educational effort that we were making in the United States. There was a concern about essentially pre-promotional type activity. We had to limit the education to things such as we have today, where you have hearings, and responses to press. We were told that we could respond fully in those cases, but that we had to limit the amount of educational activity. Just about every dairy farmer and veterinarian in the U.S. knew about BST, so they did not need to be educated any more about human food safety.

Senator Whelan: My researcher was showing me the notes on the telephone calls and the recordings that she made. I will come back to that afterwards.

I recently read another submission, Crime in Agriculture. The hearings are held in St. Louis, Missouri. The presentations mostly concerned Archer Daniels Midland. The submission explained how the FDA operates and how people stay only a few months with the Assistant Attorney General until they get certain laws passed, whole big briefs. It makes me suspicious of the administration when you keep quoting them.

You cited the Quebec Veterinary Practitioners Association. In this room today are people who represent the Quebec dairy farmers. Their organization has passed a motion against rBST. You quoted this other group, but we know that there are many dairy farmers and processors in Canada who are very afraid of what could happen, the same as with the breast implants.

Mr. Bell: Mr. Chairman, I would like to respond to Senator Whelan's last comment. From a processor's and from a dairy farmer's standpoint, if you polled my clients independently, you would overwhelmingly find that they would like an opportunity. I have no problem. If a product passes the hurdles on a scientific basis, it is up to every individual farmer to decide whether to use this product or not. The farmers will ultimately decide. I have no problem with that. That is fair and honest.

From the processing standpoint, one of the issues was the question of choice. Now we are starting to get that. Organic milk is now available in Ontario. That is what the processor was concerned about, separating out milk supplies.

Senator Whelan: There are about 400 processors, plants, in Canada. They are scared to death of what could happen to them because they are responsible. It should not just be the farmer's right to decide this.

Mr. Bell: Most of those processors, as you know, Senator Whelan, are owned by the farmers. They are farmer-owned co-ops.

Senator Whelan: They are in Quebec, but not all of them are in Canada.

Mr. Bell: In the west, they are.

Senator Whelan: In Ontario, they are 80-plus-per-cent owned by the private sector. There is mostly foreign ownership in Quebec. They are concerned about this. The consumers should have some say, not just the farmer. That product is being put on the market for that consumer. There are large health organizations in Toronto and other places that have voted unanimously against the use of this product because of unanswered questions.

Mr. Mowling: Maybe I could respond to that. I have spent a lot of time recently, not only on this topic, but on others, to ensure that consumers can get access to information. As you probably know, we are restricted on what we can say about this particular product because it is still under review. Even though there are others talking about it before it is reviewed, it is very difficult, if not impossible, for us to respond. On a W-5 show recently, I could only talk about the U.S. experience with it.

We acknowledge that consumer information is as critical to these technologies as the technology is itself. Our whole company's future is built around sound scientific technology and access to information on that. We have been involved in starting up and co-founding organizations, working with consumer groups, packaged goods companies, food companies and the food industry, in putting in place an infrastructure that addresses those kinds of consumer questions. Much of that exists now, and it exists regionally.

People from my company are always willing to provide information. Groups and organizations that have credibility with consumers are out there now. They are fielding. I am one of the directors of an organization called the Food Biotech Communication Network. The Consumers Association of Canada is chaired by an academic from Guelph. There is somebody from the New Brunswick Bio-Atlantique on the board as well. They field something like 100 Internet responses a day from students, the media, and others who are asking questions about biotechnology, including BST, and other topics. It is happening now.

People are getting access to information. They cannot get too much on this product because it is not approved yet.

Senator Hays: I made a number of notes as I heard the presentation and the exchange of questions and answers. I would like to touch on the things I noted and get your comments.

As we approach this work, I note the high degree of skepticism that exists on the part of some senators here and, obviously, some people. I do not know where it comes from. Perhaps it exists because there is a commercial motivation from your point of view. In any event, we are going to have to deal with it. First, we probably need to address the colourability issue, that is, the various studies and so on which we are looking at and will be looking at. Some people feel these studies are not totally objective because Monsanto or others gives financial support.

This is our first hearing on this. This issue has been commented on, but perhaps not directly. I bring this up directly for your comment.

Mr. Kowalczyk: It is an interesting catch-22. There is a need to run more studies. When you fund people to run those studies, you can reject the studies because they were funded by a company. Who is going to pay for the research? Most people expect the companies to pay for the research.

The catch-22 concerns me because people want to see results. You try to go out and get the very best academic scientists to do an independent evaluation, and they will tell you to a person that they believe quite strongly in academic freedom and do not believe that they are being influenced, but the results obviously can be called into question because they are funded by a company. Most of the governments we work with are unwilling to fund all of the research that needs to be done.

Senator Hays: Let me go through my list. Maybe we could come back to that if you have any comments to help us deal with that as an issue. Perhaps there is some research that has been done which you could direct us to that is not colourable or cannot be put into question, or other witnesses. Certainly, we will put that question to the next series of witnesses.

You mentioned 30 countries which have done research and have found this product to be safe, and 13 countries which have approved it for use. Perhaps it is unfair to ask you this, but are there any countries that are like Canada, where you are having problems getting the necessary approval to see the product go into commercial use in the dairy industry?

The reason for the Canadian dairy industry's success goes back a long time into the 1920s, perhaps the late teens, and the decision to measure productivity and use that measurement to improve the genetic base of the dairy herd. I must say I am not sure how a product like BST fits into this in terms of reliable data, comparative data, on a cow's productivity for butterfat or the tonnage in lactation and the protein content, whatever we measure. Is there some way of keeping the dairy industry on track, in the way it has traditionally been, with this additive?

It occurs to me that, as you say, management is the key to this. You are increasing the dry matter intake of these cows. You are getting higher productivity, but it will be more difficult to compare one genetic line to another, to say that this particular cow family or the progeny of this particular sire are superior when you add this type of variable into it. I would appreciate a comment on that.

I remember touring some facilities nine years ago. There was a question then as to whether BST is best as an additive into a cow's bloodstream or whether it is better to address the blocker. The hormone is secreted naturally, and it would be at higher levels were it not for the fact that the level of BST is maintained by a blocker in the same sort of way that the endocrine system works. It might be more easily accepted by the industry this way than by actually adding something.

You said something rather interesting in your presentation that surprised me. Farmers do not have to use the product if they do not want to. Was there ever a suggestion that they might be required to use it?

Mr. Bell: No.

Senator Hays: This is one way that we think we can increase productivity, but in Canada -- and maybe this is part of the explanation for our skepticism here -- we have a system of supply management which bases return on the cost of production. If nobody uses BST, then the production norm proceeds on that basis. If people use it, and productivity is increased, volume is increased, and the supply management system to manage supply has to make a quota adjustment or has to have some surplus removal mechanism that takes that extra product off the market to maintain the closed system of supply management. I appreciate that we have a higher level of imports post-Uruguay Round than we did before.

When you talk about one farmer being more productive than the other, I think "so what," except that the next round of WTO on agriculture starts the end of next year. We can export milk, and we are facing imminent trade action from the U.S. in doing that. Whether we will do it or not, I do not know.

Can you comment? I know that I have asked many questions, but they were on my mind. I will ask them of others, so I will ask them of you.

Mr. Bell: I will go first to the genetic question. Across categories, whether genetically superior or not, on a percentage basis, the response is the same. If it was used equally, you would only get a difference if some cows in your herd received favourable treatment.

We can do that right now. Just last week they stopped recording oxytocin, one of the available hormones, in DHIA records. There are so many fundamental things. I can feed one animal better than I can the other if I truly want to skew the data.

The majority of my farmers are not interested in that. They want to select the best genetics under the available management styles, so they treat them all equally. We feed a majority one-ration TMRs now. We balance it to the best of our ability. We look for performance from the animals that fit that management system, that feeding style. That is where we make our selections. The farmers are not interested in skewing the figures.

Senator Hays: Does that not dramatically reduce the genetic base you are selecting from? Without rBST, you are selecting from a total base. You select within a herd, or perhaps a series of herds, that have similar management.

Mr. Collier: I would like to address this question. Genetic progress is made through the male. You use the best sires as mates for your cows. When you look at these sires, they have thousands of daughters with production records, some of which may have been treated with some somatotropin. When you look at the impact of whether a cow has had somatotropin on that sire's estimate of heritability, the differences become environmental effects. Whether a farm is using it or not becomes a farm environmental effect.

The bottom line is that it will not affect sire selection. It cannot affect cow families because you only have one or two daughters from a given cow. You can skew potentially a cow decision, but not a sire, not which bulls you pick.

Senator Hays: On the bull's daughters' rate of production, on the progeny of the bull, you will have management that uses BST, management that does not use it, those that use it well and those who do not use it well. Am I assuming then, when I look at that expected progeny differential for that particular bull, or whatever the measurement is, that it is going to be less reliable because the regime has variables in it that it did not have before?

Mr. Collier: They have looked at that very carefully on the sire side. It will not affect sire selection because of the huge numbers involved. When you look at cows, if you milk three times a day, you will get the same level of milk yield increase, whether or not you use BST. It has no effect. It does not improve milk composition, and neither does artificial insemination or estrus synchronization. We use all these things to maximize the efficiency of a dairy operation.

Mr. Kowalczyk: I think that issue is fully addressed in the task force. There is a whole section. I cannot remember who the academic person was. It is included in your packet there. You might want to refer to that.

Mr. Mowling: It is in section 3, Animal Genetics.

Senator Hays: Which countries are giving you problems in addition to Canada?

Mr. Kowalczyk: One of the things we have said is that there are approximately 30 countries which approved the human food safety. A number of those countries never even went to seek registration for this. In many of those countries, there were literally academic people who requested to do studies in their country. They wanted to be able to sell the milk and have it go into the food chain. We then sought to get zero withdrawal on food safety, so those countries approved it from an investigational standpoint.

As far as the countries where we have tried registrations, the only area where we are still unsuccessful is the European Union. We have been successful everywhere else that we have tried to get approval.

Senator Whelan: Does that include Australia?

Mr. Kowalczyk: We have not even tried to get approval in Australia.

Senator Whelan: They turned it down, in any event.

Mr. Kowalczyk: People keep saying that.

Mr. Collier: You cannot turn down a submission if you do not submit.

Senator Whelan: I have a news release from Australia here.

Senator Hays: We will get into that maybe with some other witnesses.

Mr. Collier: It was not based on human safety or animal safety concerns in the European Union. They had concerns about the impact on the Common Market dairy policy.

Senator Hays: I have a follow-up question on the issue of competitiveness, cost of production, and the way supply management works. How we pay for the product is based on a scale. Efficient producers make more than inefficient producers. This is a way of ensuring the necessary motivation for competitiveness in the industry.

Let me address your point about choice. If it were to come into use, you probably would have no choice but to use it, assuming that it does increase productivity by up to four to five kilos. If you did not use it, you would not stay in the top half of productivity. In other words, if you wanted to stay in the dairy business and make as much money as you could, you would have to use it because it would become the norm. The cost of production formula that you used to determine how much you get for a hectolitre of milk is based on the most competitive producers. It does not pay everybody the same amount. As I said, this is to ensure that competitiveness remains a major factor, even though we do have supply management.

Mr. Bell: I would not think so. I look to the U.S., which has the same kind of market pressure, and 25 per cent of the producers are doing it. Obviously, everyone has not adopted the same technology. Similarly, multiple technologies could be adopted in Canada right now that would lower the cost of production. Some people choose not to do that. I have no reason to believe that would be any different with this product.

Mr. Collier: It is the same in the U.S. Whether or not you milk three times a day will not determine whether or not you stay in the dairy industry, but that is about the same level of increase in milk yield. The same holds true for TMRs, or the total mix rations, or the use of AI, or artificial insemination. Fifty years after the introduction of AI, about 70 per cent of the industry uses AI.

Senator Hays: Assuming that you do it yourself, milking three times a day is much more expensive than using BST, in terms of getting up a little earlier and going to bed a little later.

Senator Stratton: In Canada, with quotas, there is no real urgency for the use of this product because there is virtually no competition because of the closed system. The only way to look at this is to say that lower input costs simply allow you to have fewer cows; you would end up with the same quota.

Supposedly, there is an open market in the U.S. Let us assume that it is an open market, and a highly competitive one. You have stated that only 25 per cent of the U.S. producers are using the product. If it was that competitive, or if it lowered production costs, you would expect more than 25 per cent of producers to be using it. Why is that number not higher than 25 per cent? Is it not a higher percentage because it has just been recently introduced?

Mr. Bell: In fact, farmers do have an option outside the quota system. We have optional export quota.

Senator Stratton: I understand that.

Mr. Bell: It came through at 25 cents a litre, so the cost of production is critical for hitting that marketplace. There is an option outside the quota system. We get farms in expansion mode. The Canadian dairy industry is expanding. The majority of my clients have either made a lifestyle decision to leave the business within four or five years, or they are expanding. I am so busy because I am working on expansion models. Production costs ultimately become important, because these producers are purchasing quota at high market prices, and they have to be very cost-conscious when they go forward.

As to the second part of your question, I will speak before Mr. Collier does. I wonder why people do not use AI. Its cost effectiveness has been proven time and time again, and yet I still have producers who do not use it. Only 70 per cent of producers in the U.S. use it. I have not seen numbers from Canada, but I think that the figure is slightly higher. Some producers choose not to use it. I know that TMR mixers lower production costs. Many producers choose not to do it, and there are lifestyle choices for not doing so.

People are farmers for different reasons. They are not all created equal. Some of them prefer to go to a pasture management system, where they are more weather-dependent. The use of this kind of a product would not be as justifiable in that situation.

Mr. Collier: I would like to speak about the growth rate. This year, we are growing at 23 per cent. Last year, we grew at 25 per cent. The year before that, it was at 40 per cent. The growth rate has been relatively steady. For any new product, a 23-per-cent to 25-per-cent growth rate is extremely good. We are not concerned about that. In fact, one of our issues will be making sure we have enough capacity to meet the demand. That is why we have committed to building a U.S. facility.

Mr. Kowalczyk: I would like to point out that this is the top-selling product for dairy cows. It is also probably one of the top five products in all of animal agriculture. I am not a marketing person, but those curves indicate the earlier adopters, and the people who waited. This has been a tremendous success in the U.S.

Senator Stratton: Mr. Bell, you say farmers will do one of two things in four or five years: get out of the business or expand. Is that because of the cost of production, or because of dropping profits?

Mr. Bell: It has a lot to do with lifestyle. It has a lot to do with the average age of the dairy farmers in this country. My average producer is 45 years old. Quite a number of them are looking at retirement, and they do not have sons or daughters who want to come home and take over those farms. The majority of it is based on lifestyle issues.

The next step in expanding out of the traditional, small tie-style barns that dot the countryside is moving to a free-stall operation. We know the economics of that; it is a major step. A minimum of 100 cows is necessary to make a free-stall operation pay, and 150 cows is a better number. That is quite a decision. That is a big family decision. If producers do not have people to come in and take the farm over later, they are quite happy to be where they are. It is not that they are not profitable right now. They just do not want to take the next steps. Those choices face every Canadian dairy farmer right now.

Mr. Mowling: One advantage of this technology is that it is not capital-intensive. There is no capital investment. It is a straight expense.

Senator Fairbairn: There are many questions on this issue. It is not in the mood or the mode of being hostile or trying to prevent scientific progress, nor is it this committee's desire to downgrade production opportunities for farmers. With these additives, however, it does not matter which committee you address. These additives have repercussions. It is not just an agriculture issue, particularly if it has the hormone element in it.

I am reluctant to do this, but I will give you a personal example which demonstrates my concern about hormone use. Back in the 1960s, the whole question of birth control pills came on the market. Everybody was urged to have take them. They were the greatest thing, and many of us did take them. I had a hormone imbalance to start with, and this was definitely recommended, and so on it went. Ultimately, I almost became a casualty.

For more than 10 years, the side effects were not promoted. Side effects were not looked into as they should have been. In the end, the product was removed in the United States, but it took a while to remove it in Canada. It had to do with the dangers of things such as high blood pressure and blood clotting.

We are now receiving studies. New reports discuss a correlation between IGF-1 and cancers such as breast cancer and colon cancer. This is worrisome.

The questions that Senator Hays and Senator Stratton have asked are valid questions in the agriculture sector, but these new reports are prompting, without doubt, valid questions in the public health sector. Our concern is the degree to which one can, with confidence, dismiss concerns about something like the increased risk of breast cancer, colon cancer, or prostate cancer. What does the research show? Has there been time to justify a concern? You spoke about putting a label on something that says this "may cause" an effect. The "may cause" in my case was almost "does cause," and yet the risk was not made clear to the public. At that time, the risk was not in anybody's mind.

You are probably familiar with Dr. Hankinson's recently publicized study. It came out publicly this month. It causes concern for some of us on this committee.

Mr. Mowling: I share that concern. Working where I do, I get questioned by family and friends all the time. The rigour that is required by us in this whole process, no matter what part of our business, is absolutely critical. This is why we do not only rely on our own research to support the document, but also on third party and independent research. We have been working on this particular product for 10 years. Once again, I direct your attention to the fact that Health Canada is rigorous in terms of what it expects from us, including long-term health.

It is absolutely critical for us to address those issues, and we need to ensure that they are addressed. My experience with the Canadian regulatory authority is that there is quite a lot of confidence in the system that looks at those aspects.

Perhaps my colleagues would like to comment specifically on the issue of IGF-1 and cancer, because it does need to be addressed.

Mr. Kowalczyk: As a company, I do not think that anything we say is going to be viewed as very credible. With all due respect to Senator Whelan, however, I point once again to the Codex system or this JECFA report. I will just read this one sentence. It says: "Thus, the Committee concluded that the intake of IGF-1 will not increase either locally in the gut or systemically." That, is, in the blood system. It goes on to say:

Consequently, the potential for IGF-1 to promote tumor growth will not increase when milk from rBST-treated cows is consumed, resulting in no appreciable risk for consumers.

In your statement you mentioned the wording "may cause," but that was all related to animal health, not to human health. This report goes on to address the safety factor. This compound is so safe that an MRL, or maximum residue limit, has not even been assigned. The researchers called it "non-specified," because there is no risk there.

Mr. Collier: It is good to step back and consider whether there is a difference between treating yourself with a hormone, and what chemicals in food might affect your health. Take a compound like DES as an example. People often cite DES as an example of where implants in animals caused disease in humans. In fact, that is not true. DES and disease are related to the fact that pregnant women took DES to avoid morning sickness. They were injected with it.

DES was also used in the cattle industry, but the resulting residue levels were so low that they were undetectable when the animals were actually marketed. There never was, and has never been, a safety risk associated with DES treatment of cattle. In the public's mind, it is often connected because of this relationship between DES and other steroids and cancer. "Hormone" is a scary word.

It is often difficult when you ask what levels of safety are present. In this case, you are several levels removed because of the fact that digestion occurs in the gut.

Senator Fairbairn: By "gut," do you mean stomach or intestine?

Mr. Collier: I mean the whole digestive tract.

Senator Fairbairn: There are some questions about that, too.

Mr. Collier: There have been studies where very high doses of IGF-1 were administered, and changes in blood concentrations were examined. In some cases, part of it is digested in the stomach, and part in the intestine. The bottom line is that because of this digestion and the fact that our own blood levels are so high relative to what is in milk, they could not assess how it could have any impact. That is why they concluded, as Dave Kowalczyk just read, that there was no known risk associated with IGF-1 in milk.

If you follow that line of reasoning, if I drink two glasses of milk, is must be more dangerous than drinking one. I am not aware that there is any data showing that two glasses of milk is more dangerous than one, or drinking four glasses of milk is more dangerous than drinking two. In fact, goat's milk contains four times the level of IGF-1 in cow's milk. I am not aware of anybody showing that goat's milk as dangerous for you. In fact, it is considered a health food.

Senator Fairbairn: I do not doubt the effort that is being put into this. The concern some of us have is that the evidence in other areas within our own personal history tells us that we must be vigilant. We have to be concerned. We have to be anxious about these things, because the best research in the world can change, as it has in the past.

Mr. Bell: I agree. I do not that anybody is more concerned than the four at the end of this table. I have a young family as well. I receive my pay cheque from the Canadian dairy industry, first and foremost. Ultimately, I am really worried. I read the same reports that you do. I read the one on prostate cancer, and it was about IGF-1 blood levels. Let us be clear about what they were talking about -- it was not ingested.

If I want to make this conclusion, I should not travel to Australia because they calve cows seasonally. When cows are fresh, there are higher levels of IGF-1 in the milk. When they calve all of their cows, the milk on that shelf has higher levels of IGF-1. We have to think very closely about what Bob Collier drew out here on the board. If that were not the case, honestly, I would not be sitting here.

Senator Chalifoux: One of the witnesses stated that his presentation would not be seriously considered. All presentations are seriously considered by this committee. When the debates come, it will be seriously considered.

There is March, 1998 article from the Consumer Policy Institute of the U.S., entitled "Public Health Issues Associated with rBGH." It is written by Michael Hansen. There are two paragraphs from which I will quote. He states:

In part due to these questions, Canada has a moratorium on approval of this drug, and the European Union, which includes fifteen countries, has a moratorium on this drug until the year 2000.

The moratorium is being imposed because, as the report says, they are concerned with: "1) increased levels of a hormone called IGF-1 in milk; and 2) increased disease rates in treated cows that lead to increased antibiotic use."

I would like you to comment on another quote. The report says:

The FDA argued in 1990 that IGF-1 does not pose a human health risk because it is digested and therefore inactive in humans (Juskevich and Guyer, 1990). However, several recent studies have demonstrated that IGF-1, in the presence of the milk protein casein largely survives digestion in the stomach and passes into the intestine (Xian et al., 1995; Kimura et al., 1997). The recent JECFA meeting concluded that IGF-1 in the presence of casein does survive digestion in the stomach although they concluded that it would be eventually degraded in the intestines.

I would like your comment on that. You are presenting one side of the story, but this study is presenting another. The study also says that mastitis in treated cows increases antibiotic use. I am very concerned with this issue. It affects our own health, because it makes us more resistant to antibiotics, and we know that antibiotics are carried through to the milk and the meat. I would like you to comment on this report, and rebut Michael Hansen's findings.

Mr. Collier: First of all, the basis of the European Union moratorium is not human or cow safety, period. We can show you documents to back that up. Dr. Hansen, with all due respect, is incorrect in that statement.

Senator Chalifoux: You are saying he is incorrect.

Mr. Collier: Absolutely.

Senator Chalifoux: He is not telling the truth.

Mr. Collier: I did not say that. I said that he is incorrect. Second, relative to the digestion issue, I cited the same study. When you add casein, it does slow the rate of digestion, especially in the stomach, but it still gets digested in the lower digestive tract, the intestine. In fact, the JECFA committee calculated that, after two hours, less than 5 per cent of any injected IGF-1 would still be available. In fact, the studies are in agreement, or the information is in agreement.

Senator Chalifoux: I have one other question regarding the digestion issue. Many of us have very serious digestion problems. How would this affect anybody with Crohn's disease or digestive problems?

Mr. Collier: I am not aware of the studies being carried out in people with Crohn's Disease, but there have been studies carried out in newborns, who have very little digestive activity. In these models, there was no increase in blood IGF-1 when they were administered oral IGF-1.

Mr. Kowalczyk: In the U.S., in our post-approval monitoring program, we actually looked at how much milk was discarded due to antibiotics residues. We found there was no change before or after approval of Posilac in the United States. We examined all the key dairy states, which represent over 50 per cent of the entire U.S. milk production.

Senator Chalifoux: I have interviewed a number of dairy farmers. They are very concerned about this, because it also states that cows have a death rate that is at least two years premature. That is straight from the dairy farmers that I have interviewed.

Mr. Kowalczyk: Are they from the U.S.?

Senator Chalifoux: The ones in Canada. They die two years earlier than cows without rBST.

Mr. Kowalczyk: It is not being used in Canada.

Mr. Collier: They are not being treated.

Mr. Mowling: The product is not approved in Canada.

Senator Chalifoux: They have been getting it.

Mr. Collier: In the U.S., the issue of longevity and the culling rate -- how quickly animals leave the herd -- was looked at in the 28 herd study, and also in herds in Michigan. This study was published, and there is no difference in longevity.

Mr. Bell: We should clarify another point. The milk supply is continuously tested for residues before it ever gets to you, regardless of BST. All milk is rigorously tested. Do not worry about antibiotic residue. It does not get through the system, thanks to people like Senator Whelan.

Senator Whelan: In Eastern Ontario, a big tanker was shipped to a cheese factory instead of a whole milk factory about two years ago, and they could not make cheese out of the milk because it had too much penicillin.

Senator Spivak: The General Accounting Office in the United States has been very concerned with that, and it has said that approval should not be granted because of the antibiotic. The United States is considering imposing predetermined conditions as to when new animal antibiotics cannot be used. That is a big issue which I did not get a chance to address.

Mr. Bell: It is a separate issue from BST.

Senator Spivak: No, it is not.

The Chairman: It seems that there are many unanswered questions. The committee may have to call on you again. We appreciate the time you have given us this morning. I will allow Senator Whelan one quick comment, or is it a question?

Senator Whelan: It is apparently a comment. We do know that Monsanto gives big grants for research. I wondered if you could give us a list of the grants that you have given to academic institutions, Agriculture Canada and so on, and what the grants were for. I know you gave Agriculture Canada in Winnipeg a grant of approximately $600,000 to do a study on wheat. I wrote to ten universities that conduct a lot of agriculture research, and I asked for reports as to who gave them grants. I am just compiling that now. I am concerned about independence in research. I am interested in what is tied to the grants; if you insist on tying in regulations or restrictions. Could you provide that for us in the near future?

Mr. Mowling: I can provide that list. As you pointed out, Agriculture Canada is a world-renowned research base. We are partnering with universities and academics all over the country and all over the world. That is where the breakthroughs happen. We would be glad to provide that list to you.

The Chairman: Thank you for appearing at our hearing this morning. Our next witnesses are from Health Canada. Welcome and please proceed.

Mr. Joseph Losos, Assistant Deputy Minister, Health Protection Branch, Department of Health Canada: I will quickly introduce the branch, and then we will get into the actual topic of rBST.

The Health Protection Branch is a large and dynamic scientific organization focused purely on the health and safety of Canadians. Thirty million Canadians are touched every day by the programs of the branch, which deal with safe and effective pharmaceuticals and biologicals, safe and nutritious food, safety in environmental risks, and surveillance of disease risks nationally and internationally. Health protection, therefore, is the hurricane watch for health and safety in all of those areas.

The field of biotechnology will considerably increase the activity of the Health Protection Branch. Over the next 10 years, increases of 200 per cent to 500 per cent in biotechnologically engineered products are predicted in the fields that I have mentioned. Sixty per cent of the companies are in the field of health in this country. Most of the products in the field are also health related. Recombinant Bovine Somatotropin, or rBST as we call it, is one such product under review by the Health Protection Branch. It is important to remember that safety and efficacy are the focus of HPB's review in this regard. That is our mandate. We are looking at the health and safety aspects of this and other products.

With that I will hand off to Dr. George Paterson. I am certain that he will entertain questions throughout. The whole deck would take about half an hour to go through in total, but I am sure that the honourable senators will have questions during the presentation.

[Translation]

Mr. Paterson, Director General, Foods Directorate, Department of Health Canada: I would like to apologize for our English only submission. The French version is not available yet. It is being prepared.

[English]

I would like to apologize in advance because, having just had a quick look at the presentation by the Monsanto Company, there is some duplication. If you will bear with us, we will quickly go through the deck and then open it up to questions.

First, I will describe what rBST is. Federal government departments have roles and responsibilities, as Dr. Losos has indicated. Health Canada has a regulatory role in terms of the health and safety of drug products, but other government departments also have roles to play. Later, I will dwell on the approval status of rBST in Canada, the United States, and other countries. I will finish by discussing other implications vis-à-vis provincial-federal trade and marketing powers and labelling, because I am sure that may well be of some interest to you if this drug were to be approved.

What is rBST? Let me start by saying that bovine somatotropin is a naturally occurring protein hormone. It promotes growth in calves, and milk production in cows. It is naturally present in milk and it is broken down during digestion, just like any other body protein. Recombinant bovine somatotropin -- rBST -- is a veterinary drug that is produced through biotechnology, one of the first of its kind. When administered to lactating cows, it can increase milk production by 10 per cent to 15 per cent. It is virtually indistinguishable from natural BST. At this point, there are no test methods of which we are aware that can distinguish it in milk. It may be possible, however -- although it is not yet proven -- to measure it in bovine serum. That is, a cow blood test.

Health Canada has a responsibility to do health and safety assessments. What that means in practical terms is that we must decide whether to issue a notice of compliance that approval of a drug, in this case rBST, is safe for use in Canada, and is efficacious on the species in which it is going to be used. We are responsible for determining conditions of use -- for instance, is it to be used under veterinary prescription, or would it be available through non-prescription -- and other conditions of use that we might impose.

My next topic is post-approval monitoring. We can ask a company to undertake post-approval monitoring, and as we go through this, we will discuss what the U.S. did in terms of post-approval monitoring.

Other federal departments and agencies have a role. I will not dwell on that, but certainly Agriculture and Agri-Food Canada, the newly created Canadian Food Inspection Agency, and the Canadian Dairy Commission, are all within the Agriculture and Agri-Food portfolio. Revenue Canada has a role to play in terms of illegal importation. Foreign Affairs and International Trade has a role in terms of trade policy implications and international trade agreements. It is a significant role, of course, given the recently concluded World Trade Organization, and under that the Agreement on Sanitary and Phytosanitary Measures. Last but not least is Industry Canada, again in terms of overall development of the biotechnology industry in Canada and government policies relating thereto, internal trade and consumer perspective.

Let us consider approval status. In Canada, the only active product that we are looking at is the submission from Monsanto Canada. Its chemical name is sometribove, and its trade name is Nutrilac. We have been reviewing that submission since 1990. We were asked to review another submission, but that company requested that their 1988 submission be placed on hold in May, 1996. The only submission that we are actively looking considering is that of the Monsanto company.

Our legal authority is the Food and Drugs Act, and its regulations. For any veterinary drug, our criteria are that the manufacturer must demonstrate safety to humans, as well as efficacy and safety in the target animal. For rBST, it would be dairy cattle. Then, as I have indicated, Health Canada must issue a notice of compliance before any drug, such as rBST, can be advertised, sold or imported for sale in Canada.

Where stage are we at in the review? The review is still underway. There are two main features that I would like to highlight. One is what I call an internal gap analysis. Particularly if you are in Ottawa and follow the media, the press and the radio, there have been allegations that our internal review process is flawed; that it has not, shall I say, been democratic. To address that, we created an internal team of scientists with credentials as excellent reviewers, two from the Bureau of Veterinary Drugs, one from the Bureau of Chemical Hazards, which is also in the Food Directorate, and one from our Therapeutics Products Directorate -- our human drug directorate.

That internal team has submitted a report, which was reviewed by what we call the rBST Advisory Committee. As a result of that meeting, comments were made about the report. The gap analysis team is reviewing these comments and will either accept them in total, adopt them in part, or reject them. It is a work in progress.

We would like to complete that process because that report will offer one opinion. It will not be the only input, but we believe that it will be useful to two expert panels we have created. We cannot deny that rBST is controversial. It is controversial within Canada; it is controversial internationally. To address the scientific aspects from a broader perspective than just the Bureau of Veterinary Drugs, the Health Protection Branch, or even Health Canada, we have created two expert panels, one to look at the human safety aspects and one to look at the animal health aspects.

We have adopted a hands-off approach. With respect to the animal health panel, we have asked the Canadian Veterinary Medical Association to put the panel together and to run that process. With respect to the human health aspect, we have asked the Royal College of Physicians and Surgeons to do a similar job.Both processes are under way. Both panels are in place and have had meetings. We see that process leading to a panel report that will come to us sometime this fall.

Natural BST and synthetic BST do not differ significantly or substantially in chemical formula or in shape. An important element of proteins is the shape that they take as they are formed.

Also of note in terms of monitoring, we are led to believe that a Korean product is on the market that has a structure identical to one of the natural BST types. There is no difference in biological activity between either natural BST or recombinant BST.

The second bullet on page 9 of our brief describes the number of amino acids involved in BST and human somatotropin. RBST has no biological activity in humans, whether given orally or injected. In the 1950s, injection of animal somatotropins, including BST, were unsuccessful in promoting growth in humans suffering from dwarfism. Natural rBST and BST in bovine milk is largely destroyed by pasteurization, which of course is a regulatory requirement in Canada. The level of BST in the milk of untreated and treated cows is in the range of 0.9 to 1.6 micrograms.

Like all food proteins, BST and rBST are broken down by enzymes in the human digestive tract. The digestive products have not been shown to process any detectable biological activity.

Many of the physiological effects of BST and rBST are mediated byinsulin-like growth factor-1. Injections of rBST in cattle results in an increase in the blood levels of IGF-1. What is IGF-1? Again, IGF-1 is a basic, single chain polypeptide of 70 amino acids. It is of note that human, bovine and porcine IGF-1 are identical.

IGF-1 is produced in most organs and tissues of humans and other animal species. Daily production is about 10 milligrams in humans, with the liver believed to be the principal source of circulating IGF-1. However, the highest concentration is observed in blood. In an adult man, serum concentration is about 200 micrograms. Significant amounts of IGF-1 are present throughout the body; in human breast milk, saliva, pancreatic juice, et cetera. The mean levels of IGF-1 in most body fluids are significantly greater than those found in milk from rBST-treated and untreated cows.

IGF-1 is produced by the foetus, and the serum concentration of IGF-1 is about half the adult volume. The level varies in pregnant women. It rises four-fold during the first trimester and 10-fold in the third trimester as compared to a non-pregnant women. Concentrations of IGF-1 in human breast milk are about 20 micrograms per litre early in lactation, and six to eight micrograms per litre later. Therefore, it is found throughout the body and it varies in degrees or levels of concentration.

IGF-1 is not destroyed by the pasteurization process. However, the heating of milk for the production of infant formula reduces the amount of IGF-1 by at least 50 per cent. Human breast milk contains IGF-1 concentrations similar to those found in milk from control and rBST-treated cows.

We are cognizant of what is happening internationally in the scientific reviews that have been undertaken in the domain of human safety. Four major international reviews have been done that relate to human safety. They include the U.S. National Institute of Health, in December 1990, and the Joint FAO/WHO Expert Committee on Food Additives, in June 1992 and February 1998. Their report is out, and it will be considered by the Codex Committee on Residues of Veterinary Drug Residues in Foods in September. They basically ascertained that there was no danger in terms of human consumption. The Commission of European Communities undertook a review in January 1993 with a similar determination. As well, the U.S. Food and Drug Administration did a review in November 1993.

With regard to our efficacy review, through research trials and commercial use it must be shown that rBST will result in increased production as measured by the increased weight of milk produced. That milk must be marketable, and the milk from cows treated with antibiotics cannot be sold until the residues of the drugs have dropped to established safe levels. Those are the three main criteria of our efficacy review.

In our target animal safety review, the potential for the drug to cause toxicities, adverse effects, and increased incidence of disease must be investigated through research trials and commercial use, and found not to be of concern.

RBST is administered through injection. Owing to that, factors considered in the review would be things such as injection site reactions, nutrient intake, body weight, and body condition. We would ask the company to provide data that would assure us that there are no significant problems vis-à-vis reproduction in the cow. Mastitis would be considered in terms of cow health and welfare, but also with regard to using antibiotics, and the antibiotic residues getting into milk. We would look at cow health in terms of metabolic disease, lameness, immunological response, blood abnormalities, and effects on offspring with regard to calf birth traits, growth and health.

In 1993, the Commission of the European Communities concluded that rBST is effective in producing a significant increase in milk yields and efficacy of milk production in treated cows. With regards to animal safety, it concluded that rBST does not present an undue risk to the health or welfare of dairy cattle.

An important part of our review has been the decision by the U.S. to approve rBST and, as part of that decision, the requirement for post-approval monitoring which occurred from 1994 to 1996. In that, the FDA requested that Monsanto proactively develop an adverse drug experience reporting system, do statistically valid analyses of state antibiotic drug residue data, and do a health evaluation of 28 commercial herds representative of the U.S. dairy industry. These had to be done in different parts of the country, representing different geographic and climatic locations.

The study was designed to collect additional information about supplementation with rBST in on-farm settings, evaluate the adequacy of established use direction, and determine whether the product affects the quality or safety of milk. The results of that monitoring program, which we have tracked and we will use as our review proceeds, confirmed the safety of rBST for cows, and the safety of the milk supply from cows supplemented with it.

With regard to the environmental impact assessment, it may come as a bit of a surprise, but under the Canadian Environmental Protection Act, there is a requirement that products of biotechnology -- such as rBST -- undergo an environmental and health assessment. Suffice it to say that we, under a memorandum of understanding between Environment Canada and Health Canada, will be undertaking that. That will be part of our review, and will be written up as part of our overall decision.

The product has been approved in the U.S. There were conditions of approval established, as I have indicated. Its use is estimated to be 10 per cent to 20 per cent. It is part of the regular milk supply. Negative labelling; for example, "does not contain," has been allowed, but it must be accompanied by a statement indicating that the "U.S. Food and Drug Administration has determined that there is no significant difference between milk from rBST-treated and untreated cows." The U.S. has also allowed an affidavit system to verify rBST-free status. There are some parts of the industry, both at the production level and the processing level, that have used that.

Milk consumption is not part of our review per se, but I will give you some information on it which was gathered in the U.S. before and after the approval of rBST. Basically, it shows that before approval 15 to 60 per cent of consumers would avoid or reduce consumption of milk. Post-approval data does not seem to support that.

I have just been told that Israel has very recently approved the use of rBST. Based on reports from Canadian Missions from October to December 1997, the 18 countries listed here have approved it as well. Approval has not been applied for in Australia and New Zealand. The company could answer that better than I could. It is a statement of fact.

The European Union has a moratorium on rBST until 2000, although, as I indicated earlier, it seems to be scientifically based that it is safe in terms of human safety and animal health and safety. The moratorium is based principally on socio-economic concerns. Dairy products from countries using rBST are not prohibited.

In closing, because Canada has a supply management system in terms of milk production, the powers are shared between the federal and provincial governments. The federal government has authority over international and interprovincial trade, and the authority to set support prices for butter and skim milk powder. The provincial milk marketing boards have authority over milk marketing within their provinces. Provincial marketing boards set producer-to-processor prices for fluid and industrial milk. The provinces also have the authority to impose premiums or levies on fluid milk from outside the provinces. In the listed provinces, provincial legislation provides potential authority to require mandatory labelling of dairy products from herds treated with rBST.

As you probably know, labelling is a complicated issue. Three acts principally regulate labelling within the federal system: the Food and Drug Act, the Consumer Products and Labelling Act, and the Canadian Agricultural Products Act. Federal legal authority does not require Canada-wide mandatory labelling if a product has been found to be safe, and that is an important point.

Voluntary positive "does contain" or negative "does not contain" labelling is allowable, providing it is truthful and not misleading. Again, though, if we went down that road, it might be necessary to qualify a negative labelling statement in the same way as in the U.S. For instance, it does not mean anything else other than, just hypothetically, Health Canada has determined that milk from rBST-treated and non-treated cows is equally safe and nutritious, if that were indeed the outcome. There is no method of analysis to identify rBST in milk, so it would not be possible to directly verify the validity of negative labelling claims. However, dairies could implement an affidavit system as used in the U.S., as well as blood serum screening if testing were to be proven feasible in terms of both reliability and economics.

The Chairman: You find no discrepancy with the findings of Monsanto?

Mr. Paterson: Could I ask you to help me more? I missed their presentation.

The Chairman: My understanding is that Health Canada expects the company applying to do the research, and to present it to you. Having done that, you find no discrepancy with Monsanto's presentation to Health Canada?

Mr. Paterson: I excuse myself, Mr. Chairman. I did not hear their presentation.

We believe that the data that Monsanto has submitted to us up to this point in time is full and complete. We have not asked the company for any other data in terms of shortcomings we perceived. My caveat would be to refer back to our internal gap analysis. If gaps are identified, and if these are gaps that the company legitimately should fill, we will go back to them. Some of these gaps may be questions of a scientific nature which we would refer to the two panels that were created to seek that expert advice.

Senator Whelan: Agriculture Canada gets research grants from Monsanto and from other companies to do research. Does Health Canada get research grants from any companies?

Mr. Josoph Losos: No, sir. In one of our units, the Laboratory Centre for Disease Control, we have worked with some companies when there was an emerging infectious risk. Sometimes we would work with a company to develop a diagnostic test when none were available in the country. We have worked on meningitis, gonococcus, which is the cause of gonorrhoea, and others. When that occurs, we do not receive money from the company, and the relationship is very clearly spelled out in legal terms through our lawyers so that there is no confusion as to our role, which is health and safety.

Senator Whelan: How much have you spent on the study since 1990? You have been looking at rBST since 1990. This is 1998. Have you any estimate of what it has cost for those eight years?

Mr. Paterson: Any estimate I gave right now would be a wild guess. I would prefer to get back to you. Obviously, we have salaries over eight years for the people we have had involved in that. As far as I am aware, and I have only been with the department for just over two years, we have not contracted out any work until the establishment of the expert panels.

Senator Whelan: Is Health Canada using expert panels to help assess rBST because it no longer has the scientific expertise to conduct these assessments within its own department? Is that the reason? Have any of the members of these expert panels ever worked with Monsanto, or with any other chemical or pharmaceutical company?

Mr. Losos: The use of expert panels is quite standard in the Health Protection Branch. We use it in all of the directorates, because the Health Protection Branch has never had a monopoly on the sciences that we might need to mobilize for our health assessments. On everything from the immunization of kids to environmental risks, we mobilize expert panels on a routine basis.

Senator Whelan: I have the membership list for both panels, but I find an absence, let us put it that way, of someone from the dairy industry, someone from the consumers organization, et cetera. Concerns have been expressed by these people. Why are they not involved in the panels?

Mr. Losos: These panels were chosen specifically to look at the health and efficacy in animals and human safety, and the Royal College of Physicians and Surgeons mobilized the people on that list, specifically to look at the health and safety aspects. They are at arm's length. We are asking them for a rather tight time-frame, but we do not control them in any way. We do not want there to be any perception that we are influencing that decision in any way. For example, they will have immunological capacity and clinical capacity, which the Health Protection Branch would not routinely hire. We use this kind of panel to supplement our capacity in that way.

Your second question was on conflict of interest. We have quite a strict conflict of interest guideline in all of our panels. A researcher from an academic institution, for example, might have had relationships with a company to do clinical trials or whatever. All panel members have signed the conflict of interest declaration which says that they do not have a conflict of interest vis-à-vis this company, or any subsidiary or any relationship with any other related company.

Senator Whelan: What we heard from Monsanto and in your presentation today gives me the feeling that everything is safe. If everything is so safe, why is the review process taking so long? What is holding it up in Canada? We all read about six of your scientists, and the controversy surrounding the fact that they went public. Much of the information that they provided was not previously available to us. I cannot imagine these six people going public, if there was not some real concern as to what was going on. It has been intimated in the press that undue pressure was put on them to speed the approval up.

Mr. Losos: This review has been going on for nine years. Certainly, it would be very difficult to ascertain that we have been putting pressure on to speed them up. This product been reviewed for nine years, and the review is still ongoing. We have mobilized two expert panels to look at any gaps that might exist.

Dr. Paterson's presentation indicated the nature of the situation with other expert bodies across the country. We have not made a decision on this product yet. We will wait until the panels come up with their ruling. Any information and any data that come in between now and that will be considered in that decision.

We have not sped the researchers up. We have not put any pressure on anyone to speed anything up. Health and safety is our business. We will wait until these expert panels tell us their opinion.

Senator Whelan: Are you telling me that these two panels will be the final decision makers on this matter? I hope that some of us ordinary people who represent Canadians may have a chance to look at what these people are saying.

Mr. Losos: New data could appear over the lifetime of the panels, or immediately after the panels.

Senator Whelan: Surely you are not telling me that a strictly undemocratic and bureaucratic decision will be made, and that will be it. When we talked about Codex, they had nothing to say about that. Someone represents Codex and makes a decision on behalf of Canada, but parliamentarians do not know anything about it.

Mr. Losos: If none of our reviews show a problem with a product -- any product -- then, under the Food and Drugs Act, I do not have the authority not to approve that product.

Senator Spivak: Mr. Paterson, on page 11 of your brief you mentioned the conclusions of a list of international bodies. You did not, however, mention a 1995 National Institutes of Health conference on the IGF system, which concluded that IGFs are important cancer causing substances, and they may enhance tumour cell formation growth and even metastasis. Studies published in January and May by Harvard University and the Jewish General Hospital found links between elevated blood levels of IGF-1 and prostate and breast cancers.

Nor did you mention the General Accounting Office in the United States, which severely criticized the FDA for ignoring concerns about mastitis in cows, and suggested that approval should not be granted until antibiotic risk is validly assessed.

Also, in talking about the JECFA report, the committee did not consider the post-approval monitoring report's findings on mastitis or treatment with medication. I do not expect you to answer this. I note that, perhaps, you could get back to us on it.

According to the FDA veterinary chief, and a WHO temporary advisor to the joint expert committee, the U.S. is about to impose predetermined conditions on when new animal antibiotics cannot be used. The WHO is looking at that as well. Widespread antibiotic use in cattle, poultry and fruit is creating drug resistant germs that could wind up in food, which is a big concern.

I want to ask you about the report of this internal review committee. It submitted a draft report on April 15, and the final report was submitted on April 21. Apparently, The Toronto Star has copies of memos from senior officials, dated May 11 and 13, instructing committee members to altar the report or harm their careers. These are just allegations.

Would you be willing to have this committee look at both the draft report and the final report, as well as at the memos?

Mr. Paterson: With respect to your first point, yes, I will get back to you.

On June 10, we are having a stakeholder meeting in Ottawa to talk about antibiotic resistance in terms of the food supply. If you are available, I would personally invite you to attend that meeting.

With respect to the internal gap analysis, as I said in my presentation, the report was presented to an internal rBST advisory committee which I chair. As a result of that meeting, there was agreement that comments from committee members to improve the report should be made available to the team. These were made available in verbal form, and subsequently in written form.

The team is now reviewing these comments, as I indicated, to see whether they will be adopted in their entirety, or partially. We either expect a revised report, or that the report will come back to the team unrevised. That report will then be made available to the panels. I am somewhat reluctant -- although not in terms of democracy -- to make it available to the Senate committee at this time, because commercial information is discussed in these reports, and they contain information that may fall under the provisions of the Privacy Act. The panels have signed conflict of interest agreements in terms of not divulging commercial information. I would have to seek guidance from our Access to Information Act and Privacy Act experts as to what we could make available to the Senate committee.

Senator Spivak: If that commercial information were excised, would you be adverse to making that information available to us, including the memos, the draft report and the final report? It would help us greatly.

Mr. Paterson: I think that I would be flouting the laws of Canada if I did.

Mr. Losos: We would be happy to do that. There are some personal, unsubstantiated comments in there that are not relevant in any kind of public domain.

I should like to emphasize that this kind of report is quite routine. When we have a complex problem, we go through this process of analysis -- writing up a report and challenging it. I have managed scientists for many, many years, and I have yet to see a situation without a conflict of opinion. As a matter of fact, we welcome that kind of a conflict of opinion, because that is what science is. We want them to challenge every bit and piece.

However, where the report does contain personal attacks that are unsubstantiated, or proprietary information that we just cannot release, we cannot release that. You would be welcome to have everything else.

Senator Spivak: I return to Senator Whelan's concerns about conflicts of interest on the committee. Personally, I would be very interested in seeing any information that you have -- whatever information there is -- and the names of the people that are making these decisions, which would alleviate our concerns about conflict of interest. There have been previous suggestions of conflict of interest, in terms of Monsanto's representation at the WHO.

Is it true that Health Canada officials have stated that rBST is safe for humans? Has that been the case in the past, or am I incorrect in assuming that?

Mr. Losos: Senator Spivak, have you received the list of the names of the people on the panels?

Senator Spivak: I have not.

Mr. Losos: We have it with us today, and we will give it to you.

Mr. Paterson: As to whether Health Canada has publicly stated the rBST is safe for human health, we have, during the course of the review, made public statements based on the scientific evidence that was available. We had no reason to believe that it was unsafe, but we also have continued to say that we will reassess our position as new information becomes available. We have stated that it is safe, but the file is not closed. To return to Senator Whelan's question, that is another reason that a decision was not made two or three years ago.

Mr. Losos: It is one thing to interview a scientist who will give opinions based on his or her background, but you must see that we have put these panels together because we wish to be absolutely certain. We wish to have the best internal medicine minds in the country looking at the human health aspects of the hormones -- the immunological aspects, et cetera -- and that is why we have done it.

I believe that it is fair to say that an official statement saying that this product is safe has never been made sanctioned by Health Canada, by myself, the minister, or senior officials in the department. We would not do that, because we are still reviewing this product. Individual scientists have been interviewed, however.

Senator Stratton: In your brief, you list 18 countries that have approved rBST -- Israel will bring it to 19. You also talk about the European Union moratorium until 2000, saying that that decision is based on socio-economic concerns. Can you explain that more fully? My understanding is that the European Union has found that the drug is safe, and that the moratorium is based on socio-economic concerns. Is that correct? If I am wrong, correct me, and explain the concerns.

Mr. Paterson: That is right. As I understand it, the moratorium is predicated on the structure of the industry, cultural practices, in terms of agronomic practices, and that is it. The industry is different in Europe than it is in North America, and traditional practices are a factor as well. It is a weak answer, but that is the best I can do.

Senator Stratton: I thought that is what it would be. I just wished to confirm that.

It would appear that 19 countries, plus the European Union, have essentially said that the drug is safe. When do you expect, if you are going through this approval process, to complete the approval?

Mr. Paterson: Our eyes are not on the clock, if I can use that cliché. I believe that what Mr. Losos has said, and what I outlined in my presentation and would re-emphasize, is that we in Health Canada must be satisfied of health and safety. There are two main routes that we are taking to get further confidence in our review. One is our internal gap analysis. The second is the expert panels. A third route might also be the fact that the Joint Expert Committee on Food Additives re-evaluated its opinion, and came out with a conclusion in February of this year. That then must go to the Codex Committee on Residues of Veterinary Drugs in Food. That committee will meet in September, which is also when our panels are scheduled to submit their findings. These are two watershed events; the Codex committee meeting in terms of discussing and reviewing the JECFA report, and our own expert panels coming in with their reports.

I wish to clarify something regarding a question which Senator Whelan asked. The panels will not make the decision. The panels are providing advice to Health Canada. We will take these reports, and we will assess them, but the final decision rests with Health Canada. As to when that decision will be made -- let me reiterate that we are not watching the clock. The decision will be made when we are confident that we have all the information with which to make a sound decision.

Senator Stratton: Are we premature in what we are doing here?

Mr. Paterson: I would not look upon it as being premature. I would look upon this as an important part of how our democracy sees about an issue. Even though in Health Canada, primarily and fundamentally, it must be based on safety and scientific validity, we see this as neither premature nor useless. We see this as a very valuable part of helping us come to a sound decision.

Senator Fairbairn: If I may, I wish to say how assiduously you have been going after this issue. In a former responsibility, I can remember answering questions every day, mainly from Senator Spivak, about whether this would happen, and whether we would know about it. The answers were that until the government had completely satisfied itself that the safety indicators were protected, we would not know about it. That process went on for several years, and it is obviously still going on today. I commend you for the fact that time is not your central preoccupation -- safety is.

I have a question regarding your comments about the panels. What has kept this investigation going over the years is the fact that new information has entered the picture, and it must be scrutinized.

Is it fair to make the assumption that the things that we read, as concerned legislators and representatives, are being considered? When new things come out which trigger our interest, anxiety, or concern, are they being carefully assessed in terms of your research and investigation? That would include the recent suggestions of connections to issues of great public concern, such as breast and prostate cancer, and the antibiotic situation. Can we be assured that these elements will now receive your usual scrutiny in terms of reaching a final conclusion on behalf of the health and safety of Canadians?

Mr. Losos: Yes, senator, you can be assured that we look at all of these aspects. Our internal machinery constantly watches not only the popular press, but certainly the literature as to where the science is taking us. We attend all scientific meetings that are relevant to our various fields.

Stepping aside from rBST for the moment, any approved medication goes through the same type of scrutiny; it is called post-marketing surveillance. The companies are required to report adverse events to us as part of their licensure. With the large-scale post-marketing surveillance systems that the information age allows us to establish, if something comes up with any medication that is of concern, we work with the company, to either have them recall it, or force the recall ourselves. The vigilance systems are quite elaborate around these products -- rBST and a myriad others.

Our scientists' job is only half done when they look at the submission itself, because they must know the literature, and delve into what is going on in the world around them. The vigilance is as you describe it.

Senator Fairbairn: I am pleased to hear you say that, because we do have examples of medications and other treatments that are thought to be absolutely sound, worthwhile and necessary and, within a few years of use, the coin flips and sides effects are determined.

We need a comfort level on this issue because of what we are reading in the documents and the reports. These issues are being highlighted. It is important to have that comfort level that, and one would hope that, as you have been assiduous so far, you will continue to be so. Speed should not determine an absolutely fundamental examination of anything that impinges on these kinds of health issues.

Mr. Losos: Absolutely not, Senator Fairbairn. We know that life is not zero-risk, and the whole raison d'être of the Health Protection Branch is to be that hurricane watch, as I described. We will maintain that vigilance.

The Chairman: I wish to assure the witnesses that Senator Fairbairn never became political in any of the answers that she gave.

My question would be: Is this becoming a political issue? The health of Canadians may be subject to pressures that result from political issues in a democratic society.

Senator Fairbairn: Mr. Chairman, if I may insert that I was not political in my interventions, nor was Senator Spivak political in her questions. This is too big an issue.

The Chairman: That is the point I wish to make here. Is there a danger of this becoming a political issue, as opposed to a very serious health issue?

Mr. Losos: I will make a statement, and perhaps my colleagues will want to add to it. Health and safety is our focus. That is it. That is not negotiable; it has never been negotiable. It may be political in the minds of some people. There may be fears in the minds of the public -- not only in Canada, but internationally -- on a whole variety of biotechnologically engineered products. That is legitimate. People have a right to think about them. Our job is health and safety, and that is exactly what we will do.

Senator Hays: Let us consider the Canadian position at the Codex meeting on minimum residue levels in June. Apparently, the Europeans proposed to suspend consideration of the adoption of minimum residue levels pending re-evaluation of scientific data by the JECFA. We voted against that. That seems to be contradictory in the sense of what we are doing in Canada. Would you comment on that?

Mr. Paterson: Based on the 1992 JECFA evaluation, and based on subsequent data, in particular data coming out of the U.S. in relation to that decision and the post-approval monitoring, we proposed to the full Codex committee that a maximum residue limit for rBST was not necessary. This was because it was felt that rBST was broken down; the levels were not of any danger to health, and therefore we felt that the establishment of a maximum residue level was not necessary. Based on the reviews that we had done up until then, and also looking at the world literature, we supported that position. We went to Codex with that in mind. During the discussion, it was alleged that there was new scientific information, and that the re-evaluation of this new data should be undertaken by JECFA.

We supported the Codex committee's recommendation. However, as the debate changed, and new evidence was purported to exist, we had no problem undergoing a reevaluation by JECFA. I do not think that our position is inconsistent. Taking into consideration the information available to us at the time, we had no problem with the expert Codex committee's recommendation that there be no maximum residue level. We agreed that there was no need to establish a maximum residue level for rBST.

Senator Hays: I think I understand. You changed your minds, correct?

Mr. Paterson: No, we did not change our minds.

Senator Hays: In terms of what you are doing today, are maximum residue levels an issue for you? Or are you ignoring that as an issue in the work you are doing now?

Mr. Paterson: No. I would say that, coming out of the JECFA re-evaluation, we have assessed that, but we are also going to be asking the panels to comment on it.

Senator Hays: So it is relevant in your current work?

Mr. Paterson: Yes.

Senator Hays: It would also be relevant to your future work. You did not support a view based on Codex's belief that it was not relevant, however?

Mr. Paterson: In light of the JECFA re-evaluation, we were still comfortable with our position, but we will have the panels look at that as well.

Senator Hays: So it is more subtle than changing your position. It is consistent to worry about it, but not to support an international review of it.

Can I ask a question on the CEPA review? I know that is not your territory, but what is happening there? Can you comment on it? If you cannot, that is fine.

Mr. Paterson: Under that act, there is a requirement to do an environmental assessment for all biotechnological products. That affects the rBST submission. We are working with the petitioner, Monsanto, to identify what data we need. At the moment, we believe that much of the information that is required to do an environmental impact assessment under CEPA has already been submitted in the context of their manufacturing and human safety data packages, but we have not completed that review. I understand that such a review was a requirement in the U.S. as well, so to the extent that we can benefit from that assessment, that data package, we will be doing it. It is under review.

Senator Whelan: One of the things that we want to stress is the issue of obtaining the documents from the department. The Senate committee has the power to subpoena those documents, or to do whatever it wants to obtain them. We want those documents. With regard to your worry about commercial secrets, et cetera, I do not believe that you people have any more right to have them than we do. We intend to follow the law, and to use the power of this committee to get those documents. I think that you should know that.

Senator Hays mentioned Codex. I am sure that you are aware that I have strong reservations about Codex and how it operates. People are making decisions on behalf of the rest of society, and the rest of society does not know what they are doing.

If I remember the notes that were given to me on the Codex meeting, when the person from the Netherlands made his proposal, Canada voted against it. I am following up on what Senator Hays said. Is Canada not sending a contradictory message on the international level? Canada is not supportive of a scientific re-evaluation of rBST at the international level, but at the domestic level, that is exactly what Health Canada has been doing for four years. It sounds contradictory. As Senator Hays said, you changed your minds.

Mr. Paterson: It may be a matter of nuances, but I do not think we changed our minds. As Senator Fairbairn said in her remarks, as we have gone through this review, there have been points in time where a conclusion has been formed, or we have felt comfortable with our position. We have also, though, indicated that, as new information is available, we are not going to close our minds to it.

Going into the Codex meeting, yes, that was our position, based on the scientific analysis we had done. When Holland, on behalf of the European Union, indicated that indeed there was new scientific evidence, however, I do not think it was inconsistent for us to say, "Okay, if there is new scientific evidence, we do not have blinders on. We will look at it either as a sovereign country, as part of our review process, or through the Codex process." When it then was agreed that it would go to the Joint Expert Committee on Food Additives for re-evaluation, we accepted that, and said that we would await that review, and build it into our assessment. I would look upon it as flexibility as opposed to intransigence, but, yes, we did go in with a position which we felt was justified.

Senator Whelan: You voted against their proposal.

Mr. Paterson: Yes, we did. Where is the evidence? No evidence was tabled; it was alleged evidence. We were basing our opinion on the most up-to-date scientific evidence we believed to be available. If no firm evidence was tabled or put into the record, then it was just pure supposition.

Senator Whelan: Health Canada does not look at the economic benefits, et cetera, or at the damage that this drug can do to the whole history of the super dairy herds of the world, which have not used this kind of injection to make a cow give more milk. You do not look at that part of it at all?

Mr. Losos: No, sir. We look at the health and safety of it.

Senator Whelan: The overall economics of the dairy industry in Canada has been great for a long time. We are proud of what we have built. We do not want it to be destroyed by a decision that Health Canada makes on the use of a hormone to make a cow give more milk, just because it thinks it is safe. We think that should be taken into consideration.

You enforce the laws of importation of drugs that are not approved in Canada, do you not?

Mr. Losos: We can import drugs that are not approved in Canada under the special access program.

Senator Whelan: Are you aware of any improper importing of, for instance, rBST into Canada?

Mr. Losos: We have heard some rumours about it.

Mr. Joel Weiner, Director General, Policy, Planning and Coordination Directorate, Department of Health Canada: As you know, the Department of National Revenue, through its Customs operations, is responsible for managing the border. From time to time, we advise them of products that we think could potentially come into the country, and we remind them that they have not been approved. We have done that in the case of rBST. To the best of our knowledge, there have been fewer than a handful of incidents where product has been detained at the border. We have to rely on the Customs service to enforce the laws of the land as they apply at the border.

Senator Whelan: There have been rumours in the press about farmers crossing the border to Vermont to go to church on Sunday, but bringing back the product that they need to inject their cows to make them give more milk. You do not follow up on those rumours?

Mr. Weiner: No, sir. That is the responsibility of the Customs branch of the Department of National Revenue.

Senator Whelan: Have you ever had discussions with Revenue Canada?

Mr. Weiner: From time to time we send documentation to them. We have reminded them recently of the rBST status in Canada. That was as a result of media allegations that the product was being, or could potentially be, imported.

We formally communicated with the Department of National Revenue to remind them, once again, that the product has not been approved for use in Canada.

Senator Whelan: Have you ever talked to Monsanto about it?

Mr. Weiner: I am not aware that we have discussed this particular issue with Monsanto.

Mr. Paterson: Yes, we have. We raised the fact that there are allegations of the illegal importation of the product Posilac, which is licensed in the U.S.

Senator Whelan: I am concerned that we are shutting our eyes to what is happening. We have farmers telling us that their neighbours are using it, but that they are not using it. In the Ontario Farmer, there is a big article by a writer who observed people's participation in this illicit trade. I am concerned that no one is doing anything about it.

Mr. Paterson: We are, sir. The situation to which you refer was brought to our attention in writing. That individual's farm was investigated, and there was no evidence found of the use of Posilac.

Over the last two or three years, working with Customs, there have only been three instances, all of a minor nature, of illegal importation. Short of deploying an army, we have difficulty believing that the problem is widespread. Again, if evidence can be brought to us or to Revenue Canada, we will certainly act upon it.

Senator Whelan: How many farm organizations have made representations to Health Canada asking that this process be hurried up? Do you have anything on record?

Mr. Paterson: No, sir. As you probably know, the Dairy Farmers of Canada and the National Dairy Council of Canada, which represent the processors, both have reservations. Last year at their meeting, the Dairy Farmers of Canada moved that an audit be undertaken by the Auditor General, and that we wait until the Codex review was over. The National Dairy Council of Canada was more formally opposed to that motion.

To answer your question, no dairy organization has clamoured for this.

Senator Hays: The three hours we have spent with the witnesses this morning have piqued my curiosity. We consume IGF-1 all the time in milk and meat, and it is a hormone. Some hormones we take orally, like birth control pills, and they are taken up by the system and produce a certain result. However, it seems that this particular hormone is not taken up by the system. It is digested as a protein. Can you comment on what happens when I consume IGF-1?

Mr. Losos: We can certainly arrange for that kind of information to be presented to you.

Senator Hays: I would be interested in a reference to some material, or perhaps the name of someone who can help me. I do not know about other members of the committee, but I am curious about that.

The Chairman: I wish to thank our witnesses from Health Canada for appearing this morning. The committee may call on you again. It has been a very interesting morning.

The committee adjourned.