Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 27 - Evidence for the afternoon sitting
OTTAWA, Monday, December 7, 1998
The Standing Senate Committee on Agriculture and Forestry met this day at 1:30 p.m. to study the present state and future of agriculture in Canada (recombinant bovine growth hormone, rBST, and its effect on the human and animal health safety aspects).
Senator Leonard J. Gustafson (Chairman) in the Chair.
[English]
The Chairman: Honourable senators, the meeting this afternoon is a continuation of our study on rBST. We have before us today representatives from Monsanto.
Please proceed.
Mr. Ray Mowling, Vice-President, Government and Public Affairs, Monsanto: Mr. Chairman, before I proceed with my opening remarks, I wish to acknowledge the amount of discussion and the emotion surrounding this particular product. I can tell you that we hear the discussion, and we take this very seriously from many points of view. All of us here have families, colleagues with whom we work, and we are all consumers. I thought I should say that up front.
It is important for us to distinguish the process of scientific review. It is critical that this process -- and this has been alluded to by other speakers -- be rigorous and clear to everyone. Once that process is complete, then we can engage in the broadest dialogue with the community about the product.
I will start with a brief opening statement from our company, following which I will introduce the other members of the panel.
We last appeared before this committee in June of this year. At that time you were at the very beginning of the study on rBST. Since last June you have heard from a number of witnesses. We welcome the opportunity to return today to provide some perspective to this issue, including its value to dairy producers, generally, and the Canadian supply management system.
When we last appeared before the committee, we described what rBST is and how it works. We also informed the committee of the diligence being exercised by Monsanto and by regulators in Canada and throughout the world to ensure that this product is safe to animals and humans. I wish to take this opportunity to review some of the background on this submission for committee members.
Monsanto Canada submitted the animal health product bovine somatotropin, or rBST, to Health Canada for approval in February 1990. Over the following eight and a half years, Monsanto has complied with the regulatory process every step of the way. The Health Protection Branch currently has in its possession everything that the FDA had when it approved rBST -- including the raw data that was referred to by a speaker this morning -- and everything that the European Union's Committee for Veterinary Medicinal Products had when it scientifically approved rBST. Both jurisdictions have approved the product science.
In November 1996, the FDA and its Veterinary Advisory Committee reviewed the results of Monsanto's unprecedented two-year post-approval monitoring program for BST. This program collected additional information about the supplementation of BST in on-farm settings to evaluate safety to the cow and on the quality and safety of milk. They concluded, "...the final results of the PAMP," or Post Approval Monitoring Program, "confirms that BST is indeed safe and has no adverse effect on milk supply."
In March 1998, the Food and Agricultural Organization, or FAO, of the United Nations released a committee report reaffirming that treating cows with BST to increase milk production is safe. They concluded that "...there are no food safety or health concerns related to BST residues in products such as meat and milk from treated animals."
Over 30 countries have approved BST and we will continue to work with Health Canada to gain regulatory approval in Canada. In addition to Health Canada's review, scientists around the world have extensively studied BST. The issues raised before this committee, including those expressed earlier this morning, are not new and have been fully addressed over the years by numerous governments, international organizations and scientific groups. Additionally, the GAO, or General Accounting Office, which would be the Auditor General equivalent here in Canada, has cleared the record on the Monsanto process and the people involved in it, both employees and external experts.
Over 2,000 independent scientific studies have been conducted, and we feel that the science is complete. The consensus of these studies is clear and definitive. Milk from BST-supplemented cows is the same as milk from untreated cows. We look forward to BVD completing their review.
We believe that public and industry confidence is enhanced when the regulatory process is predictable, transparent and based on scientific consensus that is arrived at through rigorous peer review by other scientists. This is the approach Monsanto has followed in good faith, submitting research and studies to support our application for a new product registration in Canada.
The uncertainty that surrounds the approval process is disconcerting for us and does not bode well for others seeking approval for new technologies. Health Canada's Deputy Minister, David Dodge, noted before this committee that:
If it --
-- meaning the process --
-- is compromised in Canada and if developers of these products feel that it is compromised in Canada, then unfortunately they will not bother to come here because we are 2 per cent of the world market. Citizens and farmers will not have available those particular products which are available in other countries.
The rules on inventions and the work that goes into them will benefit inventors, like Canadian academics, entrepreneurs or companies like ours. If data is released -- and, again, this was referenced this morning -- anyone can use it. We need rules in line with other countries, or as Dr. Losos said, the developments will go elsewhere.
We believe our corporate reputation has been unfairly affected by false claims and by connection to broader examination of practices at the Health Protection Branch, which have nothing to do with Monsanto.
On a personal note, I can tell you that the colleagues I work with and their families are feeling pretty bad about this kind of publicity, as well. I might also add that these issues have been addressed by officials of Health Canada going back to 1994 and even prior to that.
We are a life sciences company. Our future depends on scientific review and acceptance of the new technologies we develop. We are extremely conscious of our responsibility to offer products that are safe, efficacious and provide value to our customers and the consuming public.
BST is a proven productivity tool for dairy farmers. It enhances milk production, and the milk from cows supplemented with BST is the same nutritious and wholesome product that consumers have always enjoyed.
Questions have been raised during these deliberations about the interest and acceptance of this product that has been on the market since 1994 in the U.S. Let me give you the facts.
Over 13,000 producers are using POSILAC in the U.S., not the one or two mentioned this morning. This represents over 30 per cent of dairy cows. Year-over-year sales are up 45 per cent. Over 100 million units of POSILAC have been sold. It is the largest selling dairy animal health product in the U.S. These are commercial numbers, but they reflect some of the realities of what has been happening in the U.S.
It is important to take the time necessary to respond to questions once the science review is complete. Monsanto will work to ensure that there is a responsible market introduction. We are very interested in working with both producer and consumer groups to respond to their questions and concerns during the time frame between the regulatory approval and market introduction.
With me today are two dairy producers, one from Wisconsin and one from Illinois, who can speak to their own personal experience with BST. They are Michelle Wieghart of Cave Creek Jerseys in Spring Valley, Wisconsin, and Linnea Kooistra of Kooistra Farms in Woodstock, Illinois. Also here are Jean Szkotnicki, President of the Canadian Animal Health Institute, and Rob Bell, a veterinarian from southwestern Ontario. I know you will find their perspectives interesting and valuable. In addition, one of Monsanto's veterinarians, Dave Kowalczyk, is here to answer any further questions you might have about the science supporting BST.
I am looking forward to the day when the scientific review with Health Canada is complete and we can begin a dialogue with Canadian dairy farmers and the other interested organizations. Thank you.
Ms Linnea Kooistra, Kooistra Farms (Illinois): Honourable senators, I am a third-generation dairy farmer from northern Illinois. My husband and I are partners, and in addition to milking 280 cows, we also raise some corn, soybeans and cash crops.
We are one of the largest farms in our area, being 70 miles northwest of Chicago, near a small rural town of Harvard with a population of 6,000 people. The Harvard area used to be a very strong dairy region. We have a celebration once a year called "Harvard Milk Days," where we celebrate milk for an entire weekend. In the last several years we have had more urban encroachment from Chicago. Many of our dairy farmers have retired and their land is being sold for development. We are the fastest growing county in Illinois and the fourth-fastest growing county in the country. We face many urban pressures, which create challenges as well as opportunities.
I should like to give you some background on the history we have had with BST. In 1990, my husband Joel and I were milking about 100 cows. Monsanto approached us to see if we would be interested in participating with the FDA in a trial herd for BST.
I had heard about BST, but did not know much about it. My first concern was human safety. I was not going to be using a product on our cows until I was sure that it would be good for us to drink. We drink our own milk on the farm.
I did my own research. I found out about all the independent health organizations that had already long ago approved BST for human safety, including well respected independent organizations, the American Medical Association, American paediatric and dietetic associations and major organizations in the country.
I decided that human safety was not an issue for me. We went ahead with a trial process to determine if it really worked, if there were health safety issues, what the profitability would be, and if this was a tool we could use on the farm.
After the six-month trial ended, my husband and I were both convinced that this was something we would like to be able to use on our farm. When BST was approved in 1994, we started using it immediately.
It has been almost five years now that BST has been approved in our country. First, we feel that BST allows us to keep cows on our farm longer. A big issue on dairy farms is sometimes just getting cows pregnant, because after a cow has a calf, milk production increases and generally it tapers off down to nothing. Unless that cow can continue to get pregnant every year, we will end up selling that cow.
In order to be profitable, we want to keep cows on our farm as long as possible. Therefore, in using BST, we are able to have more profitable cows for a longer period of time so that the window of opportunity we have to get that cow pregnant is now longer. That is a benefit to us.
We also feel that the use of BST has helped to enhance our awareness of management issues. The more comfortable our cows are, the better the quality of their feed, and the more feed we have, the more profitable we are in general and the more our cows respond to BST.
We use BST as a management tool. It is one of many tools available to farmers, but as independent producers, we feel we should have the choice to use whatever technology is available that can help us in our business.
With BST, we do not have to add on to the barn. If we wanted to increase our standard of living, we would have to buy more cows, build a barn, and we would have increased veterinarian costs, utility costs and all those other things. With BST, we are able to get more milk, with the same number of cows. We feel that extra milk is the cheapest milk we produce because we do not have the extra expenses involved.
We know that it works for us. We get about an 11- to 12-pound response from our cows, on average. We are using BST in about 75 per cent of our cows right now. Basically, we are sold on BST as a tool for the dairy farmers in our country.
I shall now turn to the public response to approval. As we were involved early on and because we are in a more urban area, we have had exposure to the press and the ability to discuss things with consumers.
Some of our neighbouring farmers were very concerned about this product when it came out. Some of them were simply asking questions. Some of them were not ready to start it right away, but because they knew we had past experience with BST during the trial period, they had questions about how it was working. Generally, the farmers in our area are all using BST now. Again, it is an individual decision any farmer can make.
As we are in an urban growth region and have the ability to talk to consumers, my husband and I feel that it is part of our mission on the farm to try to educate the non-farm public on agricultural issues. With the urban encroachment in our area, it is paramount in our view.
We have a farm breakfast once a year and we invite people out of Chicago to have breakfast and a farm tour. We had about 500 people that Saturday morning for breakfast. We also give school tours and tours to international tourists who come into Chicago for one reason or another and want to see a dairy farm.
We have always been very open in sharing our use of BST. We feel that people have questions, and we are able to address them. People who come to the farm actually see that the cows are healthy and doing fine. This helps to allay concerns that people might have.
We have never had anyone come to the farm with whom we could not talk to them and discuss the issues.
We have had a significant amount of media coverage. Six months after the trial, the largest amount of coverage took place, and then again after BST was approved.
After that six-month period, the media coverage died down because people's questions were pretty much answered. They felt comfortable with the product, so we did not have much press out to the farm. We feel that the product in the United States is very strong. As dairy producers, we feel that it is essential to us.
Cows are our livelihood. We would not be doing anything to our cows that would not be healthy for them because we rely on them for our living.
We appreciate your concerns about safety issues. As a consumer, as a mother, I am concerned as well. That is why I did my research before we ever participated in this trial.
I would be happy to answer any questions later. I am happy to be able to share our experiences with you.
Ms Michelle Wieghart, Cave Creek Jerseys (Wisconsin): My husband and I are dairy producers. If we are talking about generations, we are first-generation dairy producers. My husband did come from a dairy farm in Maine, however, his father sold out the farm and eventually we relocated to Wisconsin.
We have 38 registered Jerseys. This is a small herd by Wisconsin standards, which has an average of 61 cows. There are 23,000 dairy herds in Wisconsin. There are more dairy herds in Wisconsin than any other state in the United States. Wisconsin produces over 14 per cent of the milk in the United States. We have many dairy producers, many farms.
I shall tell you about my farm before I tell you what BST meant to us in terms of our profitability. We are calving seasonally. We calf our cows between September and the end of November, which is a little different. Many people who talk about seasonal calving do it in the spring. We set it up that way initially because I was a professor at the University of Wisconsin, River Falls, teaching dairy production. I have a Ph.D. You do not need a Ph.D. to use BST, however.
We set it up that way because I was teaching and because traditionally milk prices in the United States are highest in the fall months, so we figured that if our cows are calving and we have that flush of early production in peak milk, we could get the most money we could for all that milk.
We did that. We also practised managed intensive grazing during the summer months, when our cows are in late lactation. We use sand bedding in our tie stall barn. I do not know if there are many producers in Canada who do that. You put bedding keeper behind the cows, and four to six inches of sand for the cows to stand on, which is very comfortable for them. We also milk our cows with a pipeline system so the cow stands in her stall and you walk around and milk her.
BST has meant to us 10.6 pounds more milk per day per cow. I will tell you what that translates into for us, as a small farm. Our average milk production, what we get on average for our milk for every 100 pounds of Jersey milk, which is higher in protein and higher in butterfat than Holstein milk, has averaged $16.45 per hundred pounds for the last five years. With the production we have in our herd, we are getting $8.93 in milk income per cow per day on average through the year because our cows average throughout the year 54 pounds of milk.
POSILAC means that we get an additional $1.36 in milk income. That is after the cost for the POSILAC is deducted from the extra milk income we get. That is significant and that is why we use POSILAC. We make more money and it is a tool for the small dairy producer to earn more money. I realize you have a very different supply and management system for marketing your milk in Canada, however, in the United States it is pretty much every person for himself or herself. You want to make as much money as you can on your farm to be able to continue to do what you are doing.
We have not seen any changes in our level of somatic cell count. We have never, in the years we have been milking cows since 1980, had a deformed calf. However, the herd is really too small, it is a statistically insignificant number, so I could not say we had a change. We never had them but we still do not have them.
I have not had questions about animal health in terms of POSILAC. I will say that some of our neighbours, when it first became available and we started using it as soon as it was commercially available, had questions in their minds about why I would give a shot to a cow that is not sick. However, the way I always looked at it is we give shots to cows to help them stay in the herd for reproductive reasons.
Ms Kooistra mentioned that reproduction is an issue and so we use the prostaglandin Lutalyse to help our cows to cycle so we can catch them in heat and get them bred. From that perspective, I never had a big issue with giving a shot to a cow every two weeks so that she could be more profitable for me.
I feel that POSILAC is a tool that is particularly well suited for small herds. We had no big initial investment to use that product. I did not need to go out and spend $5,000 or $8,000 for a mixer, or for any special cropping device. We have a very low input. We purchase our winter feeds from our neighbours and we get hay from Nebraska. A big machinery investment for 38 cows never made much sense for us.
As I mentioned, I have a Ph.D. in dairy science. My speciality is nutrition. I taught for five years at the University of Wisconsin, the River Falls campus, from late 1989 to 1995. That was during the very controversial years in Wisconsin when people were questioning what BST was in the first place and whether they should label their products if BST was approved and that type of thing. We therefore discussed this in my classes. The number of comments or the mind-set that people had about it is very similar to some of the things I am hearing today. I have head many good questions, and that gave me a somewhat different perspective perhaps.
In Wisconsin, it was very emotional. For some dairy producers it was particularly so because they were afraid of losing their milk market; they were afraid people would not buy their products if they used BST. That is why labelling the product was debated so hotly. In states except for Vermont it has become a non-issue.
Milk production today is greater than it has been. In 1997, the United States produced and consumed just over 156 billion pounds of milk. If you remember the milk price I gave you for the last five years, on our farm we get an average of $16.45 for 100 pounds of milk. Our last milk cheque was for $23.22. That tremendous jump in price, which has happened this fall, is because there is not enough milk right now. That is why butter prices are so high. Milk is going everywhere it can and they are actually importing butter now. Milk consumption seems to be up and there seems to be, at least in the United States, some demand for dairy products. That has been very good for us of course because it means we are making more money.
You face many challenges in Canada, and your situation is very similar to ours in the United States. As dairy producers, we talk about going to a worldwide market, and this is a global economy today. One of the things I see and read is that we are having some real struggles trying to understand how we can implement this and still protect and help our producers make a good living.
In Canada, your producers may not want BST now and they may not need it now. Even if we had a managed quota system, for us, because we use BST, that means I can milk 38 cows in a 38-cow barn instead of milking 46 cows and get the same amount of milk out of those 38 cows. It is a nice tool for us and it helps us make a better living from that portion of our family income that comes from the farm.
Dr. Robert Bell, St. Mary's Veterinary Clinic (Ontario): Today I should like to look at the potential economic impact of a product like rBST in Canada when we have a supply managed system and to speak to this question of need.
I was born and raised on a dairy farm in southwestern Ontario. I graduated from the Ontario Veterinary College in 1978 and I have been in veterinary practice since. In the last seven years we started a corporation that started to look at farm economics, Agri-Smart Consulting, back in 1991. We have done a great deal of work in that area since.
I was also a board member from when Ault Foods was spun out from John Labatt until it was taken over by Palmer Nat last year. I was on the board of directors of Ault Foods. I have had an opportunity to look at this from two sides.
I am also a member of several veterinary advisory boards for pharmaceutical companies, Monsanto included. That is the basis on which I will talk to you to today. I wish to talk about farm economics in Canada and the supply managed system. I am here to tell you it does work, that it has worked well for Canadian dairy farmers in the past. I have no doubt in my mind it will continue to work well in the future. That is not to say there is no place for rBST in a supply managed system.
Many have said there is no economic benefit in increasing milk production per cow in a supply managed system where farm-gate pricing is based upon a cost-of-production formula. That is a ridiculous statement, and I will explain to you why. The free-moving segment on farm is the price of quota. That is set on a monthly basis by buyers. Quota is exchanged freely. P5, which includes Quebec east, trades equally. Ontario was in that system and opted out last year. Ontario trades on its own. The Western provinces trade separately. Obviously, when you have a free system like that, the lowest-cost producer can best afford to purchase. That is a pretty simple system. Low cost production is important to Canadian dairy farmers because of the price of quota.
We have approximately, given current quota prices, $4.75 billion invested in dairy quota on farm in Canada. It is a tremendous investment, and farmers must maximize how they handle that investment. Virtually every dairy farmer in Canada must come to reality with the cost of quota at some point. It either happens in intergeneration transfer or farm expansion, which of course occurs when there is industry rationalization. We are losing dairy farms in Canada at exactly the same rate as they are in the U.S., which is 4 per cent a year. That quota must move. We do have increased production due to improved genetic and management techniques. That forces farmers to go back to the marketplace to buy quota on an ongoing basis. My clients do it all the time.
Over and above the quota system, in recent years there has been another opportunity for dairy farmers, and that has been optional export programs. Milk produced inside optional export programs receives the lower farm-gate price, but it does not have the same quota attached to it, so there is no need to purchase quota to produce milk for those programs.
Many producers in this country think we sit in a very lucky part of the world. We have tremendous forage production capabilities, great climate conditions for the dairy industry, and we truly can be competitive on an international basis as the export market for dairy products increases around the world. However, there is no question that that will fall into the hands of lowest-cost producers.
I have had an opportunity to do benchmarking studies on Canadian and U.S. dairy farms. I have done benchmarking studies in Ontario, and I just completed one in the U.S. I used dairy herds from Wisconsin, Minnesota, Illinois and Indiana. Those were completed in September 1998.
Interestingly enough, that had nothing to do with Monsanto. Every U.S. producer that was in that benchmarking study was using rBST. I find it a little difficult to think that there are only a few people using rBST in the U.S. at this point. There was no exception, and that had nothing to do with the study. It was a side bar question that was asked on the benchmarking study.
One of things we heard in those benchmarking studies is that the key to success in agriculture is economy of scale, that we must be big to be profitable. That is not true. One of the most highly correlated things to farm profitability is asset utilization. We will spend some time talking about that today. That truly is important for understanding the competitiveness of Canadian dairy farmers in the future. Our herd sizes are smaller than those in the U.S.
Many Canadian dairy farms operate on tighter margins than their U.S. counterparts because of the purchase of quota that has occurred over the last few years. They were lower-cost producers than their U.S. counterparts as well. These are very competitive business people who run their businesses well, and I am proud to work with them on a daily basis.
Quota is allotted on a daily production basis. At this point, if you are under quota, two options are used in and out every day. They either milk those cows more often a day, so that milking three times a day becomes popular if milk production drops, or they milk more cows. RBST in a supply-managed system would offer a third alternative, which is not having to go out and make that capital expenditure on cattle, but increasing milk production. You have heard today that there is little doubt that there has been a response, and some data from the U.S. large herd studies show that this product does what it says it does.
That has considerable advantage over purchasing cows where you run the risk of disease transmission between herds, which has been an issue in Ontario and Quebec over the last two years.
The most important asset on the dairy farm is the cow, and its maintenance cost is key. A mature Holstein cow will consume about 11 to 12 kilos of dry matter intake or feed per day to survive. As milk production increases, dry matter intake increases and more nutrients become available for milk production. The bottom line is that this is what the dairy business is. As a matter of fact, for a cow producing 25 kilos of milk per day, 61 per cent of her intake goes for maintenance. Compare that to a cow that is producing 55 kilos of milk, and 42 per cent of her intake is for maintenance. Feed costs represent 40 to 50 per cent of the cost of producing milk. It is pretty easy math to see that you can return 10 per cent to the bottom line quickly by increasing production.
That has changed the whole way we look at dairy farms. We used to rate debt on dairy farms based on a per-cow basis. I was one of the people that pushed to change that. We now rate debt on dairy farms based on a per-litre-of-milk-produced basis. I just finished teaching a seminar to the Royal Bank's risk management team on agricultural debt lending and what is profitable and what is not. These are some of the issues that we are looking at.
RBST simply takes advantage of this scenario. It causes cows to eat more, allowing them to produce more milk. Quite contrary to what you heard this morning, this has environmental benefits, not detriments. There is a reduction in urine, methane and manure output per unit of milk on rBST-supplemented cows. That has not been talked about much, but it is a real situation.
In order to predict what the farm-gate impact would look like in Canada, I took the Ontario benchmarking study that was completed this summer and overlaid production data produced from U.S. dairy farms on top of that. I took those herds and compiled their data together and created an average farm. I overlaid the production data, and I took a look and said, "Look, what are the economics of this? Would this work in Canada?"
I made several assumptions when I did that. I used current quota prices. I used the selling price per BST. I extrapolated from the U.S. price and came up with CAN$9 per dose. I used $15 an hour for labour so we could look at alternative techniques for increasing production like three times a day milking and compare them.
A table in the back of my presentation shows the economic impact of BST. Let us not argue about this question of need because the bottom line is that it delivers to the bottom line of dairy farmers. You can clearly see with those criteria I just explained, the compiled data on those farms, that they would have seen a 25 per cent increase in net farm income before taxes and depreciation by using rBST.
With farm-gate prices, many of my farmers have additional business, cash crop being one of them, and cash crop prices are at an all-time low. Farmers are a proud people. They do not want government handouts; they want to run good sound businesses. You must provide those opportunities to them. In fact, this study showed that instead of $35.50 a hectolitre, which was the cost of production on those amalgamated compiled farms by the utilization of rBST from the production data shown in the U.S., those costs would drop to $33.30 a hectolitre prior to financing. When I say "prior to financing," that is debt load, not the purchase price of the BST. In fact, optional export programs have been offered to farmers in the $34 hectolitre range. I am telling you that the group I benchmarked could not take advantage of that system without rBST in place.
That shows that rBST ended up being more profitable than alternative mechanisms such as three-times-a-day milking, and that is important. About 30 per cent of my clientele at the present time milk three times a day. Some are waiting to see if this product will be approved.
Milking three times a day creates many problems for them, both in terms of labour management and lifestyle issues. A number of them would stop that program and implement this product instead if they had the opportunity.
Some of the talk this morning was interesting. Everyone claims that there is a difference, that there are higher IGF-1 levels in this milk. With all the controversy about this product, and if there is such a difference in the milk, I find it surprising that no one has come up with a test to differentiate.
Senator Spivak: There is a test.
Mr. Bell: No, there is not because the milk is the same.
There was also some discussion this morning about antibiotic residues. I can assure you that every load of milk in Canada is tested for residues. It is not just a Mickey Mouse test. The milk is broadly screened for a wide range of antibiotics, and the penalties are severe. There is no risk to the milk supply in this country.
The other issue we should understand is that 3 per cent of our market share quota, which I suspect has climbed somewhat, comes from U.S. milk.
I back the scientific review process 100 per cent. I think this product should go through the scientific review process like every other product. After that, I think it is up to the individual Canadian dairy producer to decide whether they would like to benefit from using this technology.
Ms Jean Szkotnicki, President, Canadian Animal Health Institute: Honourable senators, I want to thank you for the opportunity to appear before you today to share with you the Canadian Animal Health Institute's (CHI) opinion about the Bureau of Veterinary Drugs (BVD) and its role in approving new animal pharmaceuticals.
I should explain what the institute is. I know we received some honourable mentions earlier this morning. We are the organization that represents the manufacturers of pharmaceuticals, biologicals, pesticides and food additives used in veterinary medicine and livestock agriculture here in Canada.
You may ask why I am here today. I want to state very clearly that I am not here representing Monsanto, or the approval of recombinant bovine somatotropin. Rather, I am here to support a science-based approval process for all animal pharmaceuticals.
Senators should be aware that CHI has been concerned about the operation of BVD for many years but hoped that through dialogue and goodwill, problems could be corrected. We recognize the vital and essential role of the BVD, but have been frustrated at the long delays experienced with our submissions. At last, faced with accusations that we have improperly exerted pressure and influence to get products approved, it is time for us to speak out.
I would like to give you some background on our beliefs. First, we believe it would be unacceptable and irresponsible for Health Canada to approve a product that is not safe. Second, it would be unacceptable and irresponsible for Health Canada to withhold from the market a product that met Canadian requirements. We accept and support the role BVD plays as gatekeepers of these two functions. We really believe in their role and very much accept and support it.
However, we have one proviso. We believe the work that the BVD does in those two functions of approving products that are safe and going through the risk assessment process that that work be done effectively and efficiently. This last point relative to effectiveness and efficiency is not happening. Please consider the following third-party assessments of BVD.
The first piece of information that I wish to provide to honourable senators is a table and figure depicting submission flow at the bureau. This is with regard to all submissions at the bureau that are coming in. This is the bureau's own data. It is obtained by Brogan Inc., an Ottawa-based consulting firm, and has been compiled by them.
As you can see, the graph more accurately illustrates what has happened with review times for new drug submissions, which are the new chemical entities and other submission types. We have seen dramatic increases from 1996 when cost recovery was introduced by the federal government. The category of new drug submissions has been the most severely affected, moving from a time frame of 344 days in 1996 to 713 days in September 1998.
Honourable senators, you need to know that the government's own administrative time frame for review of these types of submissions is 180 days. We are now at 713 days for new drug submissions. The BVD is not meeting its own standards of performance.
It needs to be understood that submissions under review in Canada more often than not are submissions that have been reviewed in other developed countries and likely have been on the market in those countries well in advance of Canada. Canada is increasingly becoming the last jurisdiction approached with a new drug submission because BVD is viewed as highly unpredictable. Therefore, what BVD reviews is not generally new science; it is often science and products that other countries have approved and, in many cases, are using. The research and development cost of bringing in a new food animal pharmaceutical from discovery to market is estimated to be, on average, over $250 million overall. Companies choose to submit dossiers in jurisdictions that are considered to have high scientific standards while being predictable. This is in an effort to anticipate when they will begin to recover on the substantial pre-market investment they have made.
The Canadian regulatory process is increasingly viewed as non-competitive relative to other countries. This compromises our competitiveness. As a major exporting nation, we cannot risk losing our competitive edge. If animal pharmaceutical manufacturers were exerting such undue pressure, about which you have heard, then we are certainly doing a poor job as can be seen by the increasing time to review new submissions at the bureau.
These increased review times mean our veterinarians and food animal producers do not have access to safe and effective animal pharmaceuticals at the same time as other countries, many of which we compete with globally.
What has created this untimely situation relative to access to safe and effective animal health products in Canada? I invite you to read the 1998 KPMG workplace assessment for the Bureau of Veterinary Drugs. This study was commissioned by Health Canada. It was an assessment of BVD and provides insight into its operations. In this study, KPMG conducted 15 interviews with BVD managers and the staff.
The study itself demonstrates that BVD is an agency in need of significant change so that it can be an effective and efficient organization in making timely decisions relative to the review of new animal pharmaceuticals. CHI believes that rBST is a symptom of a much bigger problem at BVD. Processes need to be established within the bureau to better manage its overall performance and human resources.
Furthermore, CHI strongly contends that careful, peer reviewed science is the best tool we have on which to base our decisions. The issue of food safety is paramount to all of us, and it has been talked about here. We all have families. We are consumers as well.
It is CHI's opinion that BVD needs to implement a proper and disciplined scientific dispute mechanism. Objections to a product would need to contain factual information for presentation in support of an objection. Failure to do so would mean that the objection could not be heard.
In our view, a disciplined and transparent dispute mechanism that requires the same rigour and objectivity from both sides of an issue needs to be established.
We are citizens seeking to contribute to the Canadian economy and the activity of this nation. Collectively, animal pharmaceutical manufacturers are proud of the contributions they make to a better society and to better animal health. All we expect from the review process, though, is an even-handed approach and fair treatment. That has not been our recent experience.
Mr. Mowling: Mr. Chairman, our group would be pleased to respond to any questions senators may have.
The Chairman: Thank you very much for those brief submissions. You covered a lot of ground in a short time and we appreciate that.
Senator Hays: Like you, as a farmer, I also use lots of Monsanto products. They clearly give us an advantage in terms of our productivity, but you are having a rough time with this one, in terms of getting it approved for use in Canada.
This is a product that is approved for use, and is presumably being used, in 30 countries, and in the U.S. for at least five years. What is your experience with regard to potential problems with its use? Do you have any information coming your way that would indicate you should be on guard or worried about this product in actual use? There could not be a much larger test group than the one in the United States at the present time. What is happening on that front? How do you monitor it? What are you hearing?
Mr. David Kowalczyk, Director, Regulatory Affairs, Monsanto: First, I should like to make a correction. While we have approval in over 30 countries, it is actively commercialized in about 10 countries, such as Mexico, Brazil and South Africa. I should point out that, outside Canada, in the rest of the world, we actually distribute our product through another animal health company, Elanco. They are really responsible for pursuing our commercial interests in other parts of the world.
We have responsibility for monitoring any reports of adverse experiences from anywhere in the world, and we submit them to the regulatory agency. Our most proactive monitoring program has been the one in the U.S. because we have direct distribution to every single farmer that buys the product. We have continuous contact with them, we are not going through a distributor, so there is no fire wall preventing information from getting to us.
One of the advantages we had in our post-approval monitoring program was that we continually called our farmers, finding out the experiences they had with the product. If there were any concerns whatsoever, we sent people out to review the situation. Even the FDA went out to various farms that were using the product to see if they were having problems. Our post-approval monitoring program in the United States continues. For as long as we have the approval, we submit on a periodic basis to the FDA any reports that come to us. I can tell you that those experiences now are at an extremely low level. We get very few reports of anyone even mentioning having a problem with mastitis.
Senator Hays: I was going to get to that, but, first, in terms of human beings consuming milk produced from dairy herds that use rBST, is there no adverse experience? You monitor that. Is there nothing happening there? I am just confirming that is your answer.
Mr. Kowalczyk: Your question is whether any problems in humans have been reported?
Senator Hays: Yes. There are many things happening here in terms of the economy of the dairy industry. There is an issue regarding cow health and an issue regarding potential risk to human beings who consume milk from cows who are producing milk with the use of rBST. That is my first question. There are a number of people, particularly in the U.S., but apparently in nine other countries as well, who have been, for some years, consuming milk from cows from farms where rBST is used to enhance production. I suppose that the great fear of those who wonder about the approval are wondering about the health of all those people. I am asking you if you monitor that and if there is any indication that there is any problem.
Mr. Kowalczyk: We certainly have an obligation to monitor that, and we have not had any experience with, or heard of any, adverse effects. One of the reasons for that is because the milk is exactly the same, whether it comes from cows supplemented with BST or not. BST has always been in milk. When you supplement cows with BST, the level of BST does not change. It is the same. If you take some of the conclusions of some of the people who have appeared before this committee, we should be recommending people to stop drinking milk if there was a danger with BST. You can take it to the next step on the issue of IGF-1. That stays within the normal physiological limits in dairy cows and in their milk. However, the JECFA decided to take the worst case, assume it is in the higher part of normal physiological range and do an assessment. They found there was absolutely no issue there. IGF-1 is a normal substance in people. In fact, it is something you need to survive.
I should point out that human breast milk contains more IGF-1 than cow's milk, so if you take that argument of these people to its natural conclusion, we should be recommending that mothers stop using their own breast milk and we should be using cow's milk instead of human breast milk.
Senator Hays: I do not know whether that is a good idea. I will not get into it. Perhaps you should not have. I got the answer to my question.
In terms of cow health, you have two dairy producers with you today who have small herds. I assume California is the largest milk producer. Wisconsin, we are told, is the second. Cow herds in California are between 2,000 and 3,000 head on average. What is the experience with those large operations, in terms of managing these higher-producing cows and problems like mastitis? I am assuming that, in the smaller herds, the representative producers that you brought with you today are able to manage it so they do not have any problem -- or any extraordinary problem. What about in the larger herds?
Mr. Kowalczyk: I believe Ms Kooistra has a fairly large herd.
Ms Kooistra: The size of the herd would not necessarily make a difference to how you would manage mastitis, because it comes down to keeping your cows clean and your equipment in good working order to try to lower somatic cells so that your cows do not get mastitis. That is no different for a herd of 28 or 280 or 1,200 cows. A larger herd versus a smaller herd would not make that much difference.
Mr. Kowalczyk: As far as our monitoring system, we looked at different geographical sections of the country and found no difference between places like Wisconsin or New York versus California or Arizona, where they have fairly large herds.
Senator Hays: Your label apparently indicates some potential problem -- mastitis -- when using the product. Do you have a comparison between non-users and users of rBST and their experience with that infection?
Mr. Kowalczyk: All the pre-approval work looked at the same herd, which is the best way to do a control, where part of the herd is on BST and part is not. In the post-approval monitoring program we had 28 herds, four of which were around the size of a 40-cow dairy herd; and others that were various sizes. The results showed that the risk was extremely small. In fact, in our more commercial herds that were in the post-approval monitoring program, the relative risk was much lower than the risk involved in our pre-approval studies.
Senator Hays: I have one question on economics, which is an extracurricular thing for us but it has been raised. I can see an advantage in improving cow efficiency and producing milk, but I am not sure it is the same one you have described.
Quota trades on so many hectolitres of milk.
Mr. Bell: No, it trades on kilos of butterfat.
Senator Hays: That is a unit of production, is it not?
Mr. Bell: That is correct.
Senator Hays: You have the right to market so many units of production. If you can do it cheaper than the other person, then you will make more money than the other person.
Mr. Bell: No. That is not exactly what I said. I said that you are more competitive for buying quota to produce more. In other words, you pay the same price.
Senator Hays: You can afford to buy the higher priced quota because you can make more for every hectolitre that you produce. I understand that, but I would like to explore the cost of production formula, which has a target return to a producer. That return relates to a formula to show a fair return to an average producer for his or her efforts in producing milk.
If I am a more efficient milk producer, then you are right, I will make more per hectolitre and I can justify quota costs more readily. However, it affects the whole industry because cost of production has a way of determining the return to the producer. It will reward more efficient producers in the way you described.
The dairy industry and the feather industry have become more efficient producers because we have structured our system to provide an incentive to do that. In the end, everyone has the same incentive. If we start to use a product like rBST to increase our efficiency, pretty much everyone must do it to fall into line with the end result of the cost of production formula. The beneficiary here is not so much the seller of quota -- because we hope that will be around for a long time -- as it is the consumer of the product. The consumer of the product will get it for less money but, as it matures in terms of its use in the industry, I do not see it making a lot of difference in return. Cost of production is there not to reward anyone in an extraordinary way, it is there to reward producers in a fair way. Do you agree with that?
Mr. Bell: Yes. Ultimately, you are correct. On a cost of production formula, as the industry lowers the cost of production, ultimately, the consumer benefits.
The Chairman: I have a couple of questions for either of the ladies who are the primary producers here. How often must the animals be injected to have a maximum return?
Ms Wieghart: They are injected every 14 days.
The Chairman: Have you noticed anything in relation to the lifetime expectancy of the animal?
Ms Wieghart: We have not. I do not know about Ms Kooistra.
You made the point that there is now the cow that you keep in the herd because she cannot be bred. Milk production would then tail off to the point where you would send her to slaughter and bring in another animal to put in that empty stall. I have heard comments from producers who are my friends, neighbours and clients, that this cow is a testimony to BST. She owes her life to that product because she has been milking for 600 days and has produced 75 pound of milk. The eleventh time, this producer told me that she finally conceived, so she is still alive.
The Chairman: In regards to diet, does the animal consume more in her diet because of the injection?
Ms Wieghart: Diet intake does rise. It starts to increase about two to three weeks after you give your first injection to the animal. You then continue giving injections to the animal. My experience in our herd has been that dry matter intake increased in the range of about two to four pounds. Other neighbours typically say the same thing; some people say a little less. It depends on the response you receive.
Senator Spivak: Mr. Mowling, in your statement to us today you produced a number of figures. Could we have the documents that support those figures? Could you also give us the data that you did not release to the General Accounting Office regarding the University of Vermont study? It is one thing to see this here; it is another thing to have the supporting data such as year over year sales, and so on.
Mr. Mowling: Yes; I would be glad to do that. Do you want the sales figures?
Senator Spivak: Yes, your figures on producers.
Mr. Mowling: The figures regarding the 13,000 producers?
Senator Spivak: Yes, and the evidence of year over year sales, the number of units, and so on. We would like to see those documents. Also, we would like to see the data from the University of Vermont study, which you did not give to the United States Congress's General Accounting Office. That is the research study on animal health and the increase of mastitis. We would like to see that, if we could, because we have heard testimony that is quite different.
Mr. Mowling: I am not sure what you mean by "the documents." I can certainly provide information on the sales and the data that I released. We may even have one or two pages here.
Senator Spivak: Generally, there are audited company statements. In other words, we want to see the beef!
Mr. Mowling: I can provide that. What else do you want?
Senator Spivak: I should like the University of Vermont studies that the Congress's General Accounting Office asked for but that Monsanto did not give them. Would you agree to give that information to the Senate of Canada's agriculture committee?
Mr. Kowalczyk: We do have a POSILAC update that gives those numbers that Mr. Mowling talked about.
Senator Spivak: I should like to see the actual data.
Mr. Kowalczyk: That document is also on our Web site.
Senator Spivak: Is that an audited statement? What status do those documents have?
Mr. Kowalczyk: I do not know whether or not it is an audited statement.
Senator Spivak: All right. I have put this request forward.
Mr. Kowalczyk: Concerning the question about the University of Vermont study, the General Accounting Office of the United States did review it. They issued a report on that and we made the limited data available to the University of Vermont. The FDA also reviewed the information.
Senator Spivak: I have read the documents and it does not say that. It says that there is information that you would not release to them, namely, the data. However, that is fine. If we could have a copy of that, then that would be great.
The news release that you gave us was from the joint FAO World Health Organization Committee. This is a JECFA release, "Milk and Meat from BST Treated Cows Presents No Danger to Humans Says Committee Report Released By The UN Food and Agriculture Organization."
The committee concluded that there are no food safety or health concerns related to BST residues in products such as milk and meat in treated animals. However, we have had evidence that that was not the statement and that the FAO withdrew the release months before. The FAO withdrew it from their Web site and they do not agree with that release. Is that not correct?
Mr. Kowalczyk: I would disagree with that. I would look at both the summary report that backed up the news release that came out at the same time, and also the full report from the JECFA review that was made available last month.
Senator Spivak: This says Rome, March 5.
Mr. Kowalczyk: That is correct. The JECFA meeting occurred in February. There was a news release right after that with the actual summary of the information, but the complete published report just came out a month ago. I included it in the folder we gave you. It supports the statement in the press release.
Senator Spivak: There is no document. The evidence we received is not correct; the FAO stands wholeheartedly behind that and did not withdraw the release.
Mr. Kowalczyk: Dr. Hansen mentioned this morning an interaction with the FAO. I am not familiar with that. I am only familiar with the data that was put forward and reviewed. Codex also accepted the JECFA report during its September meeting; there are no scientific issues at this point.
Senator Spivak: We have heard a lot about the long-term studies and the fact that no long-term studies were included in Monsanto's submission to Health Canada and the 90-day study. I know Health Canada received the same information that your company gave to the FDA, however, on the 90-day study, why did your company not say anything about the misreporting of findings in 1990? Also, when you had the evidence concerning antibodies and lesions, why did you not correct the error if the drug was not orally active? Why, in your freedom of information summary required under U.S. law, did you not make a reference to the 90-day study and instead cite a 28-day study, repeating that there were no biological effects on test animals that were fed the drug? Why did your company not test longer than 90 days after you saw those results almost 10 years ago?
Mr. Kowalczyk: All the raw data that was included in the 90-day study and that was submitted and reviewed by the FDA was reported in the Science article. They reviewed all the things mentioned in the gaps analysis. This data was also reviewed by the European Union in 1993 and given a clean bill of health concerning food safety. In fact, they recommended that the maximum residue limits (MRL) for BST not be specified because it is so safe they could not arrive at a number. The entire report containing raw data has also been submitted to the Codex organization, that reviewed the entire data. Also, it has been summarized in the Science article, the 1993 JECFA report, and the European Union Committee for Veterinary Medicinal Products, or CVMP. Included in the package, you will find their statements about this study and also about the antibodies. This goes back to 1993. It is not a new issue. The Science article, at the beginning, talks about these kinds of products. They talk about antibodies and things like that. It is nothing new. It has been addressed since 1990.
Senator Spivak: Are you saying there was no error in that Science article in 1990, which talked about the drug not being orally active, when in fact the raw data showed that it was? Are you saying that there was nothing wrong with the way it was reported?
Mr. Kowalczyk: The FDA did address the issue of those proteins in the early part of the article. It was also addressed in the CVMP opinion. You said the FOA summary talked about another study. We have actually done several rat studies, and all have been submitted. The 28-day study was the initial study done for the FDA. The 90-day study was required by Europe at the time. Protein products require a 90-day study, so several of us did those. Furthermore, if you look at the Science article, it reviewed not only the 90-day study but also other studies of the same type. Moreover, they all come to the same conclusion.
Senator Spivak: If you were asked to do long-term studies that look at all the factors, including toxicology, cancer, and especially the effect on children,, who would be affected differently than adults, are you prepared to do that? The lack of those studies has been indicated as a deficiency in the gaps analysis, as well as under our Food and Drugs Act, which is normally required for such a drug. No such studies were done in this instance.
Mr. Kowalczyk: There is no need to do any long-term or short-term studies. I am not alone in this conclusion; all the other organizations that have looked at this issue feel the same. We are talking about a protein-based product, a substance already present in milk. It is natural in cows' milk, thus the milk does not change. For that reason there is no difference.
Senator Spivak: You mentioned that you are monitoring human health under the PAMP. How are you monitoring the effects of rBST on human health? Could we have some documents about the methods, way of monitoring and so on?
Mr. Kowalczyk: We had a formal program, which I made available at the June committee.
Senator Spivak: Does that specify the human health issue? I thought that was mostly about animal health. Does it specify the impact on human health?
Mr. Kowalczyk: Yes, it did. It took into account antibiotics used against mastitis, and the amount of discarded milk. In the United States we actually measured in a number of states for two years prior to approval and two years afterwards. We monitored over 50 per cent of the entire U.S. milk production to see if there was any increase in violative residues.
Senator Spivak: Was there a control group?
Mr. Kowalczyk: The control group was in our 28-herd study.
Senator Spivak: Are there any other supporting documents that you could make available to us which look at the long-term impact on human health, cancer, IGF-1 and all those other things we have talked about? Is there anything you have, other than what you have given us, that we could see so that we can look at this issue and dispense with it?
Mr. Kowalczyk: Not that I am aware of. I think we have made all the information available.
Senator Whelan: We have had a lengthy presentation and I have ideas for many questions. However we do not have that much time. To the Jersey dairy farm operator, I ask you, are you not concerned? I saw a report that influenced me greatly because it talks about one breed of cattle that did not need rBST. The FDA report sent to some U.S. representatives reveals three new pieces of information. First, it shows that only one of the four BGH trials conducted in the University of Vermont on Jersey cows had been reviewed by the FDA.
All of the Holstein test herd data analyzed by Rural Vermont had not been reviewed by the FDA. The second report showed that the Jersey study had seen a huge outbreak of mastitis in the BGH group, four times as much as in the control group. Two of the 20 controls were treated for clinical mastitis compared with nine of the 20 treated cows.
There was a greater incidence of injection site reaction among the treated cows than among the controls. An injection site reaction is severe swelling and pain at the site of the injection. One of the Jersey cows injected with the BGH had such severe swelling and negative responses to the shots that she had to be removed from the experiment.
This is one of the concerns noted this morning. I have a real concern about injecting anything into a human or an animal that will make them respond, make them more productive, or run faster. Do you sell any of your Jersey cattle for breeding purposes to purebred Jersey herds?
Ms Wieghart: Sometimes we sell bulls because we are such a small herd -- we only have 38 animals. When we get really good ones, we like to keep them rather than market them. Occasionally, we will sell one in the state sale. We do not solicit people to buy our cattle on our farm for breeding purposes. We are registered Jerseys but I consider us a commercial herd.
As a scientist, because do I have a Ph.D., and as a dairy producer, I can tell you that there is contagious mastitis and non-contagious mastitis. Looking at one experiment in differences in levels of mastitis could be deceptive, because if it is a contagious form that got in there, it could have nothing to do with the fact that the animals were given a product, whether they were given BST or an extra feed. It may have been spread by people milking the animals.
The somatic cell levels in our herd ranges because we seasonally calf. Those of you who are dairy producers know that the somatic cell levels tend to be higher when cows first freshen and late in lactation. Our range in somatic cell levels goes from about 50,000 up to about 200,000. The average for the whole year is always between 100,000 and 200,000.
That has not changed after we adopted BST. It is still in that same range. Over the years that we have been using BST, we have had only one cow react to it; it seems to allergic to it. After her second injection, we realized that. She had a little bump there and it did not go away, so we stopped giving it to her.
Senator Whelan: Are either one of you compensated in any way by Monsanto?
Ms Kooistra: Monsanto will reimburse me for my travel expenses coming up here. That is the compensation. I am here because I have a passion for educating people about agricultural issues.
Senator Whelan: So do I.
Ms Kooistra: Frankly, I had never been to Canada before and I have heard that Ottawa is a beautiful city. I brought my daughter with me, who is a college student. I thought it would be a great educational opportunity for her as well. I would like to take an opportunity to share with you the issue of somatic cell and mastitis on our farm.
In the United States, we get paid for quality milk. We get higher premiums for milk with lower somatic cell levels and other measurements of quality. It is to our benefit to try to keep the somatic cell levels low, not just for the cow's health but for our own financial benefit.
The vast majority of our herd is on BST and we get one of the highest premiums from our milk processor because we have a low somatic cell count. Cows, as they get older, tend to get mastitis more just because they are older and have produced milk for so long. We will just take those cows off BST and not even bother giving it to them. We have had a few cows that have reacted to a site. Then we might try a different site and if she reacts again, we will just not give her BST. Only a few have reacted.
Senator Whelan: You did say in your presentation that you only inject 75 per cent of your cows.
Ms Kooistra: Yes, the protocol for BST is after day 63, I believe. We always inject our cows on a Monday. Our injection day is every second Monday. That is BST day. After a cow reaches that point the next Monday, she will get her shot. There are 60 days in her lactation when she is not getting that drug. As well, as we take the cows off BST three weeks before they would go to the dry period. In the last two months of their pregnancy, they are not milked at all.
When we take the cows off BST, the milk production just drops like a stone. We are able then to dry that cow off. Those cows in that period of their lactation, whether they are in the dry period or in the first 60 days of their lactation, are not getting the product.
Senator Whelan: Regarding what you said about Canada and Ottawa, it is a capital city of which we are very proud. It has one of the most beautiful Parliament buildings in the whole world, and I have seen a big part of the world in my career.
Ottawa also has a parliamentary system where we really like to dig into things and that is why we are digging into this thing. Dr. Bell knows this.
You are talking about economy here, but I am sure you are aware that in the last 20 years we have 50 per cent fewer dairy producers and more than one-third fewer dairy cows, which are giving more and higher-quality milk than ever before. We did this all through good nutrition -- and the Bell family was part of this -- and good genetic breeding. I am amazed that a man by the name of Bell would come forward and say that we need to have some artificial hormone injected into our cows to make this economic thing better. Do you know a group of dairy farmers in the world who are any better or more efficient producers than those in Canada?
Mr. Bell: No. Our benchmarking studies showed that. Our farmers are very competitive and do very well.
Ultimately, based on the science review of products, they will individually decide whether they will use a product or not. I am all for a scientific review of a product. After that, let us stand behind our scientific review process and allow those individual producers to decide whether to use that product.
I know numerous producers who would use this product. One of the reasons is so that they could stop milking three times a day and still produce the same amount of milk.
They each have their licence. Each and every one has their own decisions to make on whether they will use this product or not.
Senator Whelan: I am aware of that. I hear the scientific evidence -- as you can see from the documents spread all over the desk here from some very highly qualified scientists who question this product. We have been given evidence that questions this product. I cannot believe that these people are so wrong and you are so right.
Mr. Bell: I cannot speak for Health Canada, but I have reviewed all the documents as well. I have reviewed every piece of literature I could find on this product.
Do I stand behind the science, behind the product? I certainly do.
Senator Whelan: I will ask you, Dr. Bell, the same question I asked the other two dairy producers. Are you paid by Monsanto?
Mr. Bell: No. I will get my flight reimbursed.
Senator Whelan: You were a director of Ault Dairies.
Mr. Bell: I was.
Senator Whelan: Were you aware that three people in Canada got awards from the Dairy Council of Canada -- Sam Ault; the head of Dairy Farmers of Canada, who was from Alberta; and a guy by the name of Whelan, for creating the best dairy industry in the world?
We sold our cattle, our semen, our embryos all over the world on our ROP, our record of performance. How in the world can you maintain that if you inject a purebred registered Holstein or Jersey cow with a shot of this stuff -- rBSt? Then the person said, "Did you use rBST?" That shoots the whole history and the record that we built for 75 or 80 years.
Mr. Bell: I own cows as well, and I trade in embryos and livestock around the world. When international buyers come in to see cattle that I own, that is not even a question. It is a competitive factor for us, because the U.S. does have this product available, and we do not. In the U.S., they do not ask whether or not these cows are on rBST. At this point in time, it puts us at a disadvantage for marketing animals.
The good news is the good cows respond the same way that the poor cows do. I have seen a lot of U.S. dairy farms. A lot of the people that I buy and sell cattle from in the U.S. are using the product, and the better cows are that much better again. We have not altered them; what we are doing is enhancing them.
You ask about change. There are a lot of people who do not want change in agriculture. We cannot stop it, however. We have moved ahead. New technologies are available. I try to assist my dairy clients in weighing the relative merit of all the things they are hit with on an ongoing basis. Should we implement this? What do you think the impact will be? I spend a lot of time doing that, quite apart from the rBST question. That happens all the time.
Senator Whelan: You gave a lecture to the Royal Bank the other day, and you said that big is not always best.
Mr. Bell: No, it is not.
Senator Whelan: Did you tell the Royal Bank that?
The record that we built with our cattle stands around the world. I was Minister at that time, but I did not build that record. It was the producers, the people in Agriculture Canada, and the province working together that built this tremendous record of having some of the best dairy cattle -- if not the best -- in the world. The farmers had some of the best incomes. They had to work 75 hours a week, 7 days a week.
Mr. Bell: That would be like the minister, too.
Senator Whelan: I am scared that this thing will hurt the record that we built over so many years. I find that hard to accept.
Ms Kooistra: You are part of my father's generation. My father tells me that there was a lot of reluctance when hybrid seeds first came out. A lot of people felt the change would not be good for agriculture. The same thing happened with artificial insemination. It was something that was so new. There was great reluctance, and it took a while. We look back on that, and see it as one of the great things that helped move our industry forward. It is just a reminder that this is not the first time.
Senator Whelan: I am glad you reminded me about that. I was a director of one of the first artificial insemination units in all of Ontario, down in Essex County.
When I was about six years old my dad died, and he had one of the champion bulls from the Niagara area at that time. The depression came, and I can remember that.
One of the things that they spread about me is that I am against biotechnology. That is a darn lie. No minister of agriculture in Canada's history accepted so much new, good biotechnology. Our scientists in Agriculture Canada were the first to wash out the embryos and transfer them to other carrier cattle. Our scientists did that for the world in Warsaw, Poland.
There was a doctor here the other day that said, "You are against biotechnology." That is a lie. My record shows that together -- producers working together, and provinces working together -- we built the best dairy industry without Monsanto's help. I do not buy a damn thing from Monsanto.
Ms Kooistra: I do not buy every product they sell, either.
Senator Whelan: The reason I do not buy from them is because I no longer farm.
Ms Kooistra: In the interaction today, I can see that you are a progressive man, and that you have had a great history in agriculture in this country. I am sure you were fighting for AI and that sort of thing.
Other members of the committee may not have been involved in agriculture at that time, but they would be able to see that these things have happened before. We need to rule on the side of science; investigate everything, yes, but remember the benefits science brings to our industry.
Senator Whelan: You may have heard that I attended a funeral this morning. This man who passed away was in charge of all research for Western Canada, and he worked all across Canada on different research. You can imagine how many retired scientists were there today. They, too, are blue about what is happening in research today. The independent research that once protected us is no longer there. Now we must depend on the big grants that companies like Monsanto hand to Agriculture Canada -- $500,000 to find a strain of beef cattle that is resistant to Roundup. I do not think that that is consumer protection.
Perhaps your maiden name is Irish with the blarney that you are stating. I am a strong believer in agriculture. I am scared that, no matter what I buy, I may have to buy from Monsanto or one or two other companies. Four or five companies in the world may have control of us, which I do not like. That is not the way Canada was built. We built it by working together, and by sharing and giving.
I signed more agreements with other countries to exchange scientific data than any other Minister of Agriculture in Canada's history. I did that because I believed in exchanging that data and learning from one another.
I just saw a press release about what was signed in the United States yesterday. We are supposed to be in free trade, but I never saw such a list of things that concerned them in my 11 years as Minister of Agriculture. We had an arrangement with the American Secretary of Agriculture. If I wanted to know anything, I could call the secretary's office, and no matter where he was in the U.S., he would call me back within half an hour. It was the same way in Canada. We had that for 11 years. They had it with one Minister of Agriculture, and I had it with three Secretaries of Agriculture. We had a wonderful relationship, but you did not have to have four pages of telling you what to do.
Senator Fairbairn: These are very difficult hearings, for you and for every witness that has been before us. They are difficult hearings for us. This is not a subject that one would normally want to discuss in the middle of a farm income crisis.
We have been pursuing this, but it has not been of our own initiative. We have been pursuing this because of the enormous amount of pressure from concerned groups in the country, from individuals, and from farmers. I am sure that part of that may be reluctance for change, but there is more to it than that.
This has become an issue that, amazingly enough -- because it is unknown to a great many people in this country -- has caused people to vocalize their concerns about not just the single issue, but also about the representation of things to come. I do not think it is a fear of change. Rather, because of the kind of technology that we are into at the moment, the whole world -- Canadians, ordinary citizens and groups who have been in touch with us <#0107> is concerned that we take increased care in these areas. The new technology is far-reaching, and it can have almost instant effects.
You have taken a pounding on the issue. However, as public policymakers, we must be concerned about whether or not the processes within our own government are working properly.
That is not your concern; that is our concern. This issue has become part of that, however. We have some very fine scientists within the Canadian government and in the Department of Health, and they have proven to be sufficiently concerned about the science involved in this. At the instigation of the Canadian government, they produced the gaps analysis. I would be interested in hearing what your impression of that is. Is it something that is, on the basis of what your science says, to be dismissed completely?
It certainly is not being dismissed by a great many other people. The questions that have been raised seem to be legitimate questions. At some point, this committee will make a report, we will make suggestions, and we will review testimony. At this point, the difficulty with that, however, is that our scientists are not all wrong, and you, perhaps, are not all right. This is one of the reasons for the concern about the issue before us, and for the persistence about it. I would be interested in hearing your response to the very thoughtful effort on the part of the scientists within our own community.
Mr. Mowling: We do not minimize the sensitivity of this particular topic, either. We would be the last to say that it is not appropriate to have this kind of conversation. In fact, I would ask for an opportunity to appear here again.
For us, it has been an awkward situation. I mention that we have been in this process for more than eight years. Not too many organizations can spend that long waiting to have something approved, or even to have the review completed.
The difficult part about the process with Health Canada that the deputy and others addressed last time makes it awkward for us, because that is a process that happened outside of what we are trying to work with.
For us, this BST business is an interesting part of our business now, but a very small part of it. Our whole life sciences business depends on peer reviews and predictability. It needs to be predictable.
As a sponsor, even for an academic in Canada that has done some research, anybody would like to know what has been required, and be given some kind of framework for working in that process. We would be the first to argue that a peer review of the scientific process is absolutely critical. It must be rigorous and more transparent and understood than it currently is, however.
What we have discovered in this particular conversation is that many Canadians do not have a context in which to make a judgment about this. The same is true for many other products like this, so that needs to be improved. The deputy commented about being more transparent and having better communication. We see ourselves playing a very strong role in that communication, providing our information to whoever may want it -- on Web sites, and with as much detailed information as people want access to.
The difficulty is, you cannot do that with the current rules in place. In fact, those rules exist in other jurisdictions and other countries. You cannot start communicating about a technology or product until the product has completed its review. So we have had some restrictions on our ability to talk about it. All we can talk about is the shared, published data that is available, and we have done that. In fact, we have included some of that in the handout.
Our focuses are aligned. It is your job on the public policy side, and I laud the role you are playing on that. I would not exclude us from that. If we do not have a rigorous regulatory system that is trusted by Canadians, then it will not work for any of us. It becomes a bit of a principle. That is what this is about.
It is very important to distinguish between a predictable science base and a peer review science. Science is reviewed by other scientists. That is the base that we are all about. If we can complete that part, we will then be able to move into a much more thorough conversation, and to engage people in the broadest sense in a conversation about this product. It is difficult to do that right now.
Senator Fairbairn: I understand that. We have been hearing repeatedly that there has been a yearning on the part of a number of our scientists to have the opportunity of using what they describe as raw data -- not just that which has been published -- in order to test against the concerns.
One of the most passionate groups we have heard from is the dairy farmers, who feel that they have the best-recognized product in the world here in Canada. They want very much to be -- although perhaps there are never any 100 per cents in this -- as reassured and convinced as possible, because of what has been circulating in terms of concerns.
This reputation, once diminished, will never return. It is a catch-22. There is a fierce concern that, once tarnished, the dairy product in Canada -- and nothing could be more fundamental in society, in families, and in homes than milk -- will never come back. That is pretty fundamental. That is why they are saying to take this down to the bottom line as much as you can.
Mr. Mowling: We have had conversations with the dairy farmers of Canada over the last little while. We are very much aligned with their goal of ensuring that Canadians maintain that high level of confidence in the quality of milk and dairy products. If we are not aligned really tightly with that goal, then it will not work. The difficulty is that, until the science is complete, it becomes a field day for some of the misinformation. We are aligned with that organization.
Mr. Bell: I would not stand here and say there were no heated debates about this product around the boardroom table at Ault Foods. Ault viewed itself as a technology-based company. They thought that was the future for making a difference; brand recognition and bringing technology, so that there would be a point of difference at the point of sale. That was the driving force behind Ault Foods.
Of course, the issue to them was the question of benefit. When Graham Freeman was CEO, they did not see benefit in the long term. In the long term, they would be buying their milk at a lower cost, but it looked like it would be a headache for them if there were any consumer reaction at all. We all grant that. That is why this scientific process must be squeaky clean. We could not agree more. We all want to align that.
They thought that we had the support to stand behind the peer review science process, however, because that is the best we have at the moment for the development of technology.
Senator Spivak: Independent peer review.
Mr. Bell: That is what peer review means. This documentation may be commissioned and done at Cornell University, but that data is sent out and reviewed by scientists around the world before it can be published.
Senator Spivak: That is not what happened.
Mr. Bell: I do not want to have a discussion about that. When is enough is enough? That is the point. Expert committees come back from Canada, and you have already blown them off. Senator Spivak, you must come to the point of understanding the scientific process. When is enough enough? I know that you do not want this product.
Senator Spivak: I was not responsible for the process. We have come to it very late in the game. It has gone on for 10 years, and the major reason it has been lasted this long is that the initial studies were not done. It certainly is not my feeling that peer review or scientific studies have prolonged this process, not at all.
Mr. Bell: I did not say that.
Senator Spivak: Let me see if I understand you correctly. You are saying -- and you are right -- when is enough is enough? You are saying that, at some point, the process must be over, and I agree with you -- the process must be over. However, you are not placing enough weight on the flaws in the process that have occurred until now. The responsibility for that does not rest on any single individual or group. That is all I want to say about that issue.
The Chairman: One of the great advantages of the democratic process is that we have the opportunity to disagree, and to learn from that. I hope that we do just that.
Senator Robichaud: You must know when enough is enough. I do not think it is at that stage for me yet. We have heard all kinds of testimony from very knowledgeable people, and that has raised a lot of questions. Mr. Mowling's statements says:
The Health Protection Branch currently has in its possession everything that the FDA had --
I am not impressed with the FDA right now from what I heard. In that case, did the FDA have all the information that Monsanto had and has?
Mr. Kowalczyk: I take that question personally. I do the regulatory affairs for Monsanto, and it is my responsibility and my obligation to make sure that every bit of information is submitted to the regulatory agencies. I made sure every single thing was submitted. I do not only submit our own research to the FDA; anytime any articles come out anywhere in the world, I immediately submit them to the FDA. When the gaps report came out, the very next day I notified the FDA. I alerted them to it so they could review that report.
I have made as sure as I can that every scrap of information has been submitted to the FDA. It has also been submitted to Canada, the European Union, and JECFA. JECFA was on the food safety part, not the animal side.
Senator Robichaud: You have said that you believe in the process, in peer review, and that it must be a very straight process, whereby we must come to the bottom of things. In your statement, however, you say that the uncertainty that surrounds the approval process is disconcerting, as if the exercise we are conducting right now does not bode well for those seeking approval for other new technologies.
On the next page, you say, "Citizens and farmers will not have available those particular products which are available in other countries." What do you mean by that?
Mr. Mowling: For us and for what we do, whether in human pharmaceuticals, food ingredients, or in the crop area, we need to know what kind of regulatory environment we are in, and the processes that are required of us. Canada ranks amongst the top countries in the world in terms of the process.
This particular process with this product has become unpredictable for us. We have provided information for more than eight years to support this submission. As Mr. Kowalczyk said, we do not feel that more science is required. All we have heard in the last meetings in front of the Senate is a restatement of information that has been known and available and published, in many cases, for many years. There is no new information.
When there is no new information, and we are dealing in a process that should be completing itself -- again I distinguish the scientific part from the conversation after the science is complete -- that is critical for organizations. I am a Canadian, and I would prefer to have my organization investing in Canada.
One of the most difficult conversations I have -- try having this conversation inside our company -- concerns when this product will complete the review process. I could not say that. I do not know. We have provided the science in good faith. We have operated in a professional manner, and we have provided the data.
We have continued to hold a dialogue, and we are holding one with Health Canada on the product. That, however, is what I meant when I spoke about predictability. My company and others like us -- anybody who is trying to have a technology approved -- need to know what kind of a process we must work with.
Senator Robichaud: Surely the process is proving to be a good one, because we do not have all the answers. Some people show that there is a lack of information in some areas.
Monsanto's question is when the product will be available in Canada, and the answer is that that will occur when the Minister is sure that it will be safe for human consumption and also safe for the animals. It is as simple as that. It will happen when we are confident that we have all of the information. At this point, I am not confident that we do have all the information, because I believe in some of the other people who have come before us.
Mr. Mowling: I respect that. We do understand about the process. There are two expert panels that are due to report, and they have not reported yet. I understand that part of the process. We think the science is complete, but how do we bring closure to that in a way that maintains the integrity of the regulatory system?
Senator Fairbairn: On the question of the gaps analysis, do I understand correctly that this is something that you cannot respond to until the review process has come to a conclusion?
Mr. Mowling: We are responding to parts of it. The difficulty in this is not only the predictability of the process, but also the organization within the organization. Who are we working with? The three people who were here comprised the majority of the people that we are dealing with directly on this. The gaps analysis was something that was initiated within Health Canada. We are willing to respond to questions about the technology, and we have done so as best we could without giving out proprietary data.
Several people must find the small amount of data that fits into that category, and some people might take that data and use it themselves. A lot of information is published, and we will continue to cooperate with organizations and individuals to address those needs. At this point, however, we are very solid on the science. We feel the science is complete, and that it is strong on both animal and human safety.
Mr. Kowalczyk: For example, the gaps report has been given to this expert panel, and I see that as a peer review of the science theory. That is an appropriate process, and the Bureau of Veterinary Drugs is undertaking it. They have prepared that report, and have submitted it to the expert committee, and we should wait until they come back on the evaluation. Once that comes back, it is still up to Health Canada to take all that into account and make a final evaluation.
The Chairman: What did it cost Monsanto to produce this product?
Mr. Kowalczyk: A lot. I am not a financial person, so I really do not know.
Mr. Mowling: We charge in the area of $5.50 U.S. per unit. We do not normally talk about our cost of production.
The Chairman: We understood from the American people who were before us earlier today that rBST was losing the battle in the States. When we listen to you people, it sounds like you are winning the battle. How do you answer that?
Mr. Mowling: Senator Spivak already asked for some information on that. As far as we are concerned, this business is now doing very well. It has moved past the group of early adopters that always leads in having access to technology, and has moved into that larger group of producers -- more than 13,000 of them are using it.
The total amount of dairy producers in Canada is around 25,000. That is a lot of producers. Interest in the product is growing, and the word of mouth is working. One sign of that is the fact that we are building a manufacturing facility in the United States to support the market.
Senator Spivak: Mr. Kowalczyk, you stated earlier that the FDA had all the information. That is contradicted by the FDA spokesperson, however who says that they did not receive the data from the 90-day study. He says that they only received a summary of the data, and that they concluded that the results of the rat study were non-pivotal. The FDA disputes your --
Mr. Kowalczyk: No, it does not. The spokesman was incorrect. He was unaware. He is their public relations person. In the heat of the moment, he did not check on it. Once he did check, he found that all the raw data had been submitted. I think he did correct that statement in a couple of other reports afterwards.
Senator Spivak: So that is incorrect as well?
Mr. Kowalczyk: Yes. I will give you his phone number, and you can call and ask him.
Senator Spivak: My other question concerns Dr. Ritter. In the memos, you are suggesting to Health Canada who should be on the JECFA panel. Do you think that suggesting who Canada's representative on the JECFA panel should be might be overstepping the boundaries in your relationship with Health Canada? There are memos that document that.
Mr. Kowalczyk: This is the first time I have ever heard that. I have never made any recommendation on who should be on JECFA.
Senator Spivak: There are memos and minutes of meetings that report conversations that you have had with Dr. Alexander. He denied it as well. I thought I would ask you the same question. So you are stating that you never suggested to anyone in Canada who ought to be Canada's representative on the JECFA panel to anyone in Health Canada?
Mr. Kowalczyk: I have probably asked who would be on the JECFA, because I went to Rome in February to testify before the JECFA panel.
Senator Spivak: You never mentioned in any conversation that Dr. Ritter should be the representative?
Mr. Kowalczyk: Not that I am aware of.
Mr. Mowling: We need a context of what was said in the conversation. Have we mentioned his name? Of course we have; we know who he is. He is a well-known professional who consults around the world to many organizations. However, it would be fairer to provide us with the context from which this was picked out. Then we could respond to it.
Senator Spivak: I do not have it here with me. There are memos and notes, though.
Mr. Mowling: Could we get a copy of those?
Senator Spivak: Certainly.
Senator Whelan: I want to make a comment about how much money you might have spent developing this hormone. Perhaps the chief executive officer of Monsanto receives a percentage of what you make. His pay for one year, according to figures that I have, is $69.9 million. Can I assume that he receives a commission on some of these shares, but that his pay is $69.9 million a year? That is quite a sizeable figure.
Mr. Mowling: That is published information, and that is correct.
Senator Whelan: You are aware of the presentation that the dairy processors made before this committee. Their stand is 100 per cent against this. They are very concerned that there has not been enough scientific testing, and that there is not enough evidence. They are concerned that, some day in the future, anyone who put that product in a container could be libel. Are you aware of this?
Mr. Bell: You would be aware, too, that dairy product is brought in from the U.S.?
Senator Whelan: I am very much aware of that, and I am against it. It is horrible that this is allowed to come in under the so-called free trade agreement. Free trade does not exist when you see what is happening along the border. There is a whole page of things that they will try to iron out, and that list is more complicated than it ever was before.
We do not have much sovereignty left when dairy products can be brought in from the United States that use milk from a cow that was injected with a growth promoting hormone that we have not approved -- and yet we are feeding those products to our people. That is very wrong. We have no right to tell them, "Keep that product home until we are satisfied that it is what it should be." We are not satisfied.
If you saw the letters we are receiving -- not just from ordinary consumers, but also from scientists -- I do not remember even one that is in favour of what you are proposing. These are independent scientists from Canada and the United States.
What percentage of the veterinary drugs that you submit for approval are approved?
Mr. Kowalczyk: Are you referring to Monsanto?
Senator Whelan: Yes, just your products. How many of the ones that you submit are approved, compared to the number that are submitted?
Mr. Kowalczyk: As far as Monsanto or the dairy business go, this is the only product that we have had approved in the U.S.
Senator Whelan: How many drugs have you submitted for approval in Canada? You certainly have not submitted just this one?
Mr. Kowalczyk: This is the only one that we have submitted in Canada.
Senator Whelan: How about in the United States? Who submits it for Monsanto on veterinary drugs?
Mr. Kowalczyk: Our group would be the one for veterinary drugs. We have a number of applications that are still under consideration in the U.S.
Senator Whelan: How many, percentage-wise, does the FDA approve? How many does it turn down? What is your record of performance?
Mr. Kowalczyk: It is not very good in Canada.
Senator Whelan: We have good inspectors here.
Mr. Kowalczyk: Our other applications are at a much earlier stage in the review process. We have not completed all the studies for submission. None of them have been denied, if that is what you are implying.
Senator Whelan: How many submissions have you submitted to HPB, and how many have been completely denied?
Mr. Kowalczyk: We have only made one submission to the Bureau of Veterinary Drugs, and it is for this product.
Senator Whelan: I am talking about other products. You have not submitted any other products?
Mr. Mowling: Do you mean human pharmaceuticals products and crop protection products? All of our business? I can get you the figure.
Senator Whelan: Have you ever had a submission denied?
Mr. Mowling: No.
Senator Whelan: I wanted you to define what a hormone is for me. What traits do hormones have?
Mr. Kowalczyk: A hormone is a substance that is produced in one part of the body and has an action in another part of the body. The vitamin D that you have in milk is considered to be a hormone, as is insulin, which is produced in the pancreas and has action in other parts of the body.
Senator Whelan: Are any of the proteins that you know are highly toxic, the food poisons that are taken up by human tissue following oral contact, completely sterilized and contained? Are you involved in any of that at all?
Mr. Kowalczyk: I am not sure I understand the question.
Senator Whelan: When a low dosage of these products is taken orally, can that affect the other tissues in the body?
Mr. Kowalczyk: Are you referring to BST, or to other protein hormones, or steroidal hormones? There is a big difference in their action.
Senator Whelan: I am talking about BST, and also about IGF-1, which some scientists are concerned could cause diabetes.
Mr. Kowalczyk: That was looking at changes in the milk, and that was actually reviewed. It is one of the things in the JECFA report that I submitted to you. There is no implication of any risk whatsoever with the use of rBST in the relationship with IGF-1.
Senator Spivak: There are a couple of studies that have said there is a risk there.
The Chairman: I thank Monsanto for a very full and interesting afternoon, and for answering questions here before the Senate.
Could the next set of witnesses please proceed?
Ms Kathleen Connors, RN, Chairperson, Canadian Health Coalition, President, National Federation of Nurses Unions: I come to this committee as a registered nurse, as a Canadian, as a wife, as a mother, and as the daughter of a farmer. I have quite a number of the bases covered, then, as an individual who is concerned, not only abut Canada's health care system, but also about the various products and the whole aspect of health and safety in this country.
We welcome this opportunity to address the Standing Committee on Agriculture and Forestry on the matter of rBGH and its effect on health aspects for both humans and animals. For us, health and safety are the paramount issues.
The Canadian Health Coalition is a non-profit, non-partisan organization founded in 1979 at an SOS Medicare Conference that was attended by Mr. Justice Emmett Hall and Tommy Douglas. Membership within our organization consists of national, provincial and local organizations. They represent the people who first came together to fight for public health care in Canada; women, seniors, farmers groups, labour, nurses, the poor, and the faith communities.
The first of the Canadian Health Coalition's 10 goals is to create conditions for good health. In our mind, adulterated milk poses a potential health hazard, especially for our children. We also believe that the protection of the public from food and drug hazards is a key component of the Canadian medicare system.
Poor performance of the federal government's health protection duty leads to preventable deaths. Billions of scarce health care dollars will be squandered on useless or dangerous drugs and treatment for drug-induced illnesses.
We have been following the work of your committee closely, as have Canadians across the country. You have been providing a public space to hear directly from the scientists in the Health Protection Branch who reviewed rBGH drug submissions. You have exercised democratic leadership, and you have shown Canadians why our parliamentary system needs a second chamber for "sober second thought."
The testimony has been very sobering to us as Canadians. The Health Canada scientists testified under oath about pressure and coercion to approve a drug of questionable safety. They talked about stolen files, attempted bribes, gag orders, shredded documents, and a distortion of scientific evidence. We have studied the responses from the senior managers in Health Canada. Nothing they have said, quite frankly, reassures the public that they can be trusted, or that they have been part of a solution to these disturbing problems. In the words of Helen Forsey,
There was nothing real in what they said. Instead, it was like a sparring match, scoring points; truth and falsehood were merely incidental.
That is a quote from the Hill Times of November 30, 1998.
The discussion that occurs in this committee room is also occurring across the country. I come from rural Manitoba. My mom called me the other day and told me that I was creating a stir again. She was at bingo on Wednesday afternoon, and a retired physician in the community came over and said, "Ruth is that your daughter that is raising the concerns about the health and safety of milk and other drug products?" Mom said, "Yes, it is."
The conversation then turned to how important it is that the health and safety of Canadians -- and this is a farming community -- be protected by the government. That role is very important, and the government cannot abdicate that responsibility. That is one anecdote. I know that Canadians care about what is happening in food and drug safety.
As the proceedings of your committee made clear, the particular issue of the safety of BGH has raised serious concerns of a more systematic nature. A growing body of evidence suggests that senior managers in Health Canada have implemented a biased mandate that serves the interests of industry instead of the public interest. All the evidence shows that industry is the client, and that money comes before safety. There is no evidence to the contrary.
The statement that the Assistant Deputy Minister, Dr. Joe Losos, made to this committee on October 29, 1998, that --
There is only one client for the Health Protection Branch, and that is the Canadian public --
was made following prompting from senior political staff, and in our minds does not constitute evidence.
As somebody who administers medication to the people that I care for on a daily basis, who hangs blood and uses medical devices, that is extremely chilling testimony. It does create fear in my heart, because I am libel for what I give my patients. If the department will not be the ultimate safety valve to prevent these kinds of things, I must throw up my hands and wonder who will protect the safety and health of Canadians.
I will now ask Mr. McBane to speak about some of the broader health issues dealing with the perception of bias in the policy direction and management of the Health Protection Branch. Dr. Brill-Edwards will then review the drug approval process for BGH, and comment on the significance of the testimony presented by the scientists and their senior managers.
Mr. Michael McBane, National Coordinator, Canadian Health Coalition: Our brief mentions the whole question of scientific evidence, and points to the hazards of BGH in milk. The evidence before you is overwhelming, and you know that this evidence is there.
I want to turn your attention to appendix A and appendix B from Dr. Epstein in Chicago. He has done a survey of all the literature from 1985 to 1998, including evidence that Monsanto misrepresented scientific facts. It is worthwhile to remind ourselves about how large the growing body of evidence is concerning the safety concerns. This is a point that we need to keep in mind in light of the testimony that you have heard today.
You also have heard from the courageous scientists in the Human Safety Division about their gaps analysis study. As one of the senators has already said, all of our scientists cannot be wrong. All of the world evidence cannot be wrong except Monsanto's.
We also have heard chilling evidence today in terms of the drug approval process for rBST in the FDA. A former employee of Monsanto's moved on to the FDA, and was handed this drug file in absolute and categorical violation of the conflict of interest rules governing the American agency. It was categorical, and it bordered on major fraud.
To hear the Associate Deputy Minister of the Health Protection Branch, Joe Losos say, "We have total confidence in the FDA," is chilling when we have heard about the misrepresentation at the FDA. In spite of that, however, we are basing our approval process on the FDA.
This morning, American groups presented evidence about what has happened at the FDA. Anthony Pollina explained that the physician in charge of the drug, Dr. Miller, published articles for Monsanto seven times while an employee of the FDA; seven consecutive violations of FDA Conflict of Interest rules.
The controversy at Health Canada on this drug comes at a time when the department is "in transition" from health protection to risk management. The precautionary principle, where you must demonstrate safety, is being turned on its head, and citizens must now prove harm. Under the current health protection, the Food and Drug Act puts the burden of proof on the manufacturer. Monsanto has clearly not demonstrated the safety of its product.
The Health Canada experts that were brought in to examine the potential harm or the health hazards of the drug stated that there was no scientific or human safety concern because of this drug. Of course, there is no scientific evidence to collaborate that claim.
Canadians have good reason to be worried about technology products, and concerned that Health Canada will approve them. Ken Rubin obtained internal documents through Access to Information, and they show that five, six, seven government agencies are strategizing behind the scenes to move this drug through even if the dairy farmers do not want it. Even if the consumers do not want it, even if there is no scientific evidence, they are still strategizing for the marketing of this product. It is shocking that this is occurring in anticipation of what JECFA will do.
Health Canada has written to Monsanto, saying they have no problems with this drug. The correspondence is available. We can leave it with the committee. They are saying, "We will wait on the decision until JECFA provides us with a green light." Now you know that JECFA is a contaminated body, and that it has misrepresented the evidence.
Michael Hansen told you today that when the Deputy Minister, David Dodge, brought in Dr. McLean on three days notice from Australia -- $10,000 worth of travel -- he came here and told us there were no human safety concerns on this drug. There is no evidence, of course, to back that up.
Even worse than that, however, he misrepresented JECFA, and he misrepresented this committee. I quote his submission to you today, which says that, when Dr. McLean testified on October 29 he stated his belief that, "I was satisfied with both the data that JECFA looked at, as well as the way they reported it." This is not true. This is David Dodge's star witness, and he has not told you the truth. This is what Health Canada means by going outside to buy an opinion.
To move on to the whole pattern of information and bias in the Health Protection Branch, I have also tabled with you a letter from Dr. Epstein pointing out the conflict of interest surrounding Dr. McLean. That letter is in Appendix 4 of our brief. It identifies him with the industry, says that he has no scientific expertise in the field of human safety concerns, and points out that he has not published a single peer review article, whereas Dr. Epstein has published massively. Nothing that Dr. Epstein has published has ever been refuted in a peer review journal. You should weight that when you consider who you should listen to.
You notice that Health Canada did not fly Dr. Epstein in to speak to you. I suggest to you that the reason for that is that Monsanto is their client. That is how they operate.
We have tabled evidence of bias with you in Appendix 5. You do not to just take our word for it, because you have before you documents from three separate bureaus in the Health Protection Branch.
The first one is from the Therapeutic Products Division. It says that their client is the industry, because they pay for the service, and they had better find out what the client wants, because the division wants customer satisfaction. This is after Krever, this is after thousands of Canadians have been killed by poisonous products because of the abdication of the regulator. Instead, we have moved on and have identified the people we are supposed to regulate as the client.
The second example is from the food program, strategic framework. In the food division, the client is the food industry, not the people of Canada.
The third example -- which I find even more shocking -- is from the Bureau of Biologics. Following the blood scandal, they still identify the pharmaceutical companies who dumped contaminated product into Canada as their client -- not the users of the system, and not the people of Canada. These are government documents we are tabling with you, and they prove beyond a shadow of a doubt that the client at Health Protection is the industry. Their own internal mandates spell it out in black and white.
I want to read briefly from Justice Krever because on November 25, Allan Rock, the Minister of Health, issued a series of documents and press releases marking the anniversary of the first year of the Krever Report. He claimed that the department is implementing Krever.
In his report, Krever wrote:
During the 1980s, the bureau did not decide independently whether to use its authority to require that measures be taken to reduce risk of non-A, non-B hepatitis. Instead, it relied heavily on information given to it by the Red Cross and, in effect, made itself dependent on an organization whose activities it was supposed to regulate. The relationship between a regulator and the regulated ... must never become one in which the regulator loses sight of the principle that it regulates only in the public interest and not in the interest of the regulated.
The fact that, to this day, the Bureau of Biologics identifies the blood industry as the client is one of the most flagrant mockeries imaginable of Justice Krever's recommendations. Bias in health and management, and bias in policy and management, have been introduced through the government appointment to senior positions in Health Canada generally, and the Health Protection Branch in particular, of unqualified managers who are hostile to the department's legal mandate.
The Health Coalition delegation met with the newly appointed Deputy Minister, David Dodge, and we asked him what his instructions were on the Health Protection Branch. He replied that they had to operate in the face of uncertainty, and that the whole process is geared towards not making decisions. He added that this highlights the role of science and risk management, and that we have to reach out and get the science, because the regulatory approach is an old-fashioned way to deal with risk.
He also pointed out that the inspiration for the policy is in the Neilson Task Force. That task force reported on the regulatory problems from the perspective of the private sector, and it referred to regulations as a burden on society. That is the perspective of the man who now runs Health Canada. This is further indication that industry is the client. How much more explicit can we be? It should be noted here that regulation, when you see it from the public's perspective instead of from the industry's perspective, is a legally mandated intervention by governments in the marketplace, in order to protect the interests of the public in matters of trade and commerce.
Health regulations have a powerful impact on protecting the public. Consider, for example, the whole question of labelling poisonous products. One little regulation to label a hazardous product did more to eliminate childhood preschool poisonings than 20 years of education programs and expensive poison control centres. That sets in perspective how chilling it is to hear senior management refer to health regulations as "old-fashioned." As a precautionary principle, an ounce of prevention should never be old-fashioned.
How can you expect the scientific research staff at the Bureau of Veterinary Drugs -- or any other bureau of health protection -- to render reviews that are fair, independent and based on evidence in keeping with the regulatory laws of Canada when their own senior managers are saying that the regulatory approach is old-fashioned? This attitude of senior managers is a clear signal to scientists and drug reviewers that they do not need to perform their legal duty.
This may explain to the committee why the scientists are in open revolt in the Human Safety Division and in the Bureau of Veterinary Drugs. Perhaps they believe in the rule of law. Perhaps they insist on performing their duty. I would submit that this is the reason for the revolt. There still are people at the lower ranks who believe in the law, and who are very conscientious about upholding the Food and Drug Act.
In excess of $8 billion in lawsuits have been filed against Health Canada for flagrant failure to protect health. These lawsuits will increase. The department is now moving to dump the Food and Drug Act, because, according to internal documents that are attached to our brief, Health Canada lawyers have indicated that the Food and Drug Act is too narrow on safety. It even refers to rBST as an example of a case where we should take economic considerations other than safety into account. Again, these are government documents.
The Deputy Minister told a House of Commons committee on November 26 that Canadians are more capable than ever of making health decisions on their own. What he failed to say was that Health Canada requires no labels to identify the genetically altered food we are eating. It holds secret all the information about the product, and, in spite of what Monsanto representatives said today, rBGH is not a natural product in milk. I am sure most of you know that.
If the industry and the government officials believe so strongly in this product, they will fly their genetically engineered flags proudly in the sunshine, rather than seeking to obtain profits in the darkness, by stealth.
There is another example of not being given the truth. A manager of the Health Protection Branch appeared before you this morning, and was asked point blank whether or not Monsanto asked for the appointment of Dr. Ritter. You remember that Judy Erola, a multinational lobbyist in Canada, appointed Dr. Ritter to his job. She has acknowledged this in a publication. This is a fact. There was a three-person panel, and they went out and appointed Ritter to his job when he was at the Health Protection Branch. This is the person who is now associated with Guelph, which receives money from Monsanto in its programs.
Dr. Alexander was asked if Monsanto wanted Ritter appointed to JECFA. He said he did not know about that. Access to Information documents reveal that he wrote a memo reporting on the telephone conversation he had with Dr. David Kowalczyk of Monsanto who was here a few minutes ago. We can leave this document with the committee.
At the Bureau of Veterinary Drugs, management even had discussions in their minutes about how Monsanto wanted to pack JECFA. This is very serious in terms of misrepresentation. I know that you do not come to work to be lied to, and I really hope that you will come to the bottom of this systematic misinformation of the most basic facts, even when they are documented in Government of Canada documents.
Health Canada and the minister stood up in the House of Commons to say that rBST has not been approved. We have the internal document, however, which says that they are just waiting for JECFA. On the basis of that, we should not rest assured that we will receive the decision that Canadians need based on safety.
Dr. Michèle Brill-Edwards, MD, Alliance for Public Accountability: I am a medical doctor, a specialist in paediatrics and clinical pharmacology. For a time, I was a senior physician responsible for prescription drug approvals within the Health Protection Branch. I resigned from the Health Protection Branch in 1996, in order to be able to speak publicly about my concerns regarding abuses and illegality within the drug approval process.
I am here because I was taken with Senator Whelan's question on national radio in the wake of evidence from this committee. He asked, "Can this really be happening in Canada?" referring to the abuses in the BST approval process, and then, "Is BST a singular example, or is it representative of a wider problem?"
I am here to answer those two questions. I can tell you that this is happening in Canada, and it is symptomatic of a widespread problem of abuse of the administration of the Food and Drug Act at Health Canada within the Health Protection Branch. This is not isolated to BST, but occurs in a very widespread manner, involving drugs, devices, and controversial items such as BST. This is not, in any way, a unique circumstance.
Several times over the course of the committee's deliberations, you have asked what the standards are upon which we resolve scientific uncertainty with respect to drug products, and what processes we rely on. I would like to speak to that for a moment.
Let us review the processes with respect to BST and ask what the BST experience reveals to us. The answers will show you that, in essence, the evaluation process for BST has been repeatedly and persistently thwarted. The circumstances of that thwarted process may constitute fraud, and the circumstances of that thwarted process have the hallmarks of what we have come to call the "culture of deception." It is what the retired Access to Information Commissioner calls the "culture of secrecy" that now envelops many government departments, but, in particular, the Health Protection Branch.
The processes and standards by which Canadian citizens determine which risks they are prepared to take in reference to marketed drugs in Canada are really reliant upon a very important statutory duty assigned to the Minister of Health by virtue of the enabling legislation. That duty is to uphold the Food and Drug Act. The stated intent of the legislation is to protect the public from health hazards and fraud in the sale and use of foods, drugs, cosmetics and devices.
That very simple and eloquent introduction to the Act is borne out, day by day, year by year by thousands of staff members within the Health Protection Branch. In keeping with their duty to uphold the Act as part of the Health Protection Branch, they carry out the policies and procedures that are put in place. Those procedures are designed to allow decisions to be rendered at various points in time during the development of drugs, at the point of the approval of a drug for the market, and indeed, continuing on after the drug has reached the marketplace, in order to ensure continuing safety.
The processes that are put in place are there because of the Minister's statutory duty to uphold the Act. When a company submits data in accordance with the requirements of the Food and Drug Act, they are fulfilling a legal duty. When the members of the branch -- like the scientists who have testified regarding BST -- are wading through volumes and volumes of data on safety, on efficacy, and on quality, they are undertaking a legal duty, and they must fulfil that duty with due diligence.
Likewise, their managers must render decisions on the information brought forward to them by their reviewers with due diligence. If we look at the BST process, we see that that due diligence has not been served. Let me remind you that, when we speak of due diligence, we are including the necessity for the reviewers to maintain independence and for the review process to be independent. It is not acceptable to introduce an unseen bias into the evaluation of a drug.
Reviewers are not permitted to take gifts from the industry. They are not permitted to have dinners given by the industry, nor are they allowed to accept free travel to conferences paid for by the industry. All of these things would compromise the independence of scientists and physicians within the branch, who are paid by the citizens to protect the interests of the citizens.
The whole effort here is for the minister to ensure a process that is independent and fully informed. He or she must ensure that there is due diligence in the review process, by people with adequate expertise such as the scientists. He or she also must ensure that the decision-making process after the review of these volumes and volumes of data is a process that respects the public interest, and that the benefits to citizens in Canada and the risks to the citizens in Canada are the sole focus. Considerations of the marketplace and of profit should have no bearing there.
When we examine what has taken place with BST, I can tell you that, as an expert regulator, my antenna go up immediately, and I am concerned about the appearance of fraud in this submission. The end result is that early questions that should have been answered promptly by Monsanto have never been answered to this day. That in itself thwarts the process by which it is intended for our public system to deal with uncertainty.
The process should be such that all the data available to Monsanto regarding safety, efficacy, and quality is presented to the bureau. The reviewers, who are qualified to assess that kind of information, should make an in-depth assessment of it. That assessment should identify deficiencies -- "gaps," as they are called in this committee hearing -- in the available information. A deficiency letter should then go out to the company, identifying where the information available to the people of Canada is inadequate for a decision to be rendered in favour of approving the drug for the market.
Nearly a decade after that process of evaluation first began, and even after early reports identified deficiencies, we still have no answers. Monsanto now has the nerve today to come before you and say, "When is enough enough?" Senator Robichaud gave the right answer. He said that it is enough when the Minister of Health considers that there are sufficient data to support the safety and efficacy of the marketing of the product. That is the inherent problem here, and the inherent basis of fraud that I will bring you to.
There is no one else, other than the officers of the department exercising due diligence, who can decide whether safety data are adequate or not, and who can determine what extra data they will compel the company to produce.
I go now to the actual records of the review. We have the letter of notice of compliance for human safety dated March 12, 1990, and signed by a doctor from the Bureau of Veterinary Drugs. The basis of this statement is a review that is barely a few pages long and provides no evidence, in my experienced judgment, that this product was reviewed for the purpose of identifying human safety hazards.
A senior member of the department -- and this is a division sheet, so the authority to write to a company is vested in his position -- writes to a company and states, as he does here, that the new drug submission gives the number of the NDS, and that it is in compliance with section C.08.002 of the Food and Drug Act. That is a legal commitment to Monsanto that we have performed due diligence, that we have examined the material in-depth, and that we have no further questions on human safety.
Why in heaven's name would any chief put himself at such risk as to render that kind of decision on the basis of a few pages of information that provide no evidence that the reviewer ever even asked any serious questions about the potential human safety implications of this product?
That in itself may not strike you as a basis of fraud, although, as a regulator, I do see it as evidence that due diligence was not served. This was the beginning of a process that promised to provide a multi-million dollar unlawful gift to Monsanto in the marketing of its product in our country.
We follow that along, then, with further reviews. These reviews include not only human safety, but animal safety. In 1994, parliamentary systems were taking a look at BST, and there was concern in the department that there would be a moratorium on BST. This, in essence, would counter the efforts of the senior management to push this drug to approval. At that point in time, the files of Margaret Hayden, a scientist who has already given testimony, were suddenly stolen from her filing cabinet.
To an uninformed observer, this sounds like some papers went missing. It is important, however, that you understand that this may well have been a targeted act. When a chief or a director signs off on human safety, and then an outside body begins to call for a moratorium, it is implicit that there may be an investigation, and that that investigation may uncover the absence of due diligence in the evaluation process.
At that point in time, the chief and his superiors have control over other reports that are in the official files. They can delete those, and no one will notice. They have no control over the reviewer's original draft documents, however -- her draft reports and her copy of her reports.
It then becomes necessary to erase the record that would show that due diligence was not done. It may well be that that is why those files walked away. Can we know that with certainty? No, we cannot. That is not the role of this committee, or indeed of the officers of the Health Protection Branch, however. It is their duty, upon hearing of these disconcerting events, to call for an investigation, and that has not been done.
Were these serendipitous events? The record shows that it is not likely. After testimony here from the scientists of the Bureau of Veterinary Drugs, we have the shredding of pertinent documents the next day. Is that a simple act of breaching the National Archives Act and the Access to Information Act by destroying official records? It may well be that, but it goes beyond that. It is also an attempt, in my judgment, to potentially erase the record that would show an absence of due diligence.
When you listen to the testimony, I urge you to bear in mind the proper drug approval process, the independent expertise, evidence-based process that should lead to an unbiased judgment that applies the precautionary principle, safety first, in the public interest in Canada. You must understand that the events that we are seeing here are not simple, inexplicable events, but events that fit a pattern that is consistent with fraud under the Food and Drugs Act.
The circumstances that you have been discussing, the conflict of interest involving expert panels in Canada and so-called expert committees elsewhere, is very typical of the pattern of seeking an opinion from the outside. That opinion can then be used to thwart the properly achieved independent decisions of the department's own scientists, who have been applying due diligence. Again, it is no accident that the department does not come to grips with conflict of interest. There are certainly examples that I could bring to your attention in this regard. I will forego that in the interest of time.
Lastly, I would like to point out that none of the events that pertain to BST are restricted to BST. Your agenda is focused on BST, and I must limit my comments to that. However, if you would, at some point, broaden the agenda even for a short time, I would be happy to provide you with evidence under oath of the same types of disturbing abuses of the process in relation to other prescription drugs.
Justice Krever has provided us with many examples of this that relate to blood. There are devices on the record with respect to the same problems with breast implants and the mercury amalgam. We are seeing the same problems repeated again and again. My concern is that we cannot come to grips with any of these isolated examples, or at least that we cannot come to grips with them in isolation, because we are not coming to grips with the culture of deception.
Each time we point to a problem, the department heads into the rebuttal mode. We have come to call it the four Ds of deception. First, they deny outright that there is any problem. When the denials wear thin, then they move into delay mode, saying, "this is a scientific dispute, and we need more data. We need an outside panel or a task force."
We then move to the third D, divide, where the opposition in the community is split. One side is the softies, who can be accommodated -- they can be seduced into agreeing with government. The other group is the hard-liners, and they receive the fourth D, which is discredit. We have seen all of those steps with BST, and also with the other drugs and devices that are problematic.
Do you as the privileged senior members of Canadian society, have the courage to call a spade a spade, and to identify the abuses in the drug approval process as widespread abuses that really are calling out for a broad investigation of the Health Protection Branch? I would hope that, at the end of the day, your answer would be "yes."
Ms Connors: This leads us to the Canadian Health Coalition's two recommendations.
Our first recommendation is that this committee call for a public investigation of the Health Protection Branch and the failure of his Minister and his senior management to perform their statutory duty to protect the public from health hazards and fraud.
Second, we recommend that the honourable members of the Senate of Canada call for the restoration of food and drug laboratories and safety research budgets in the Health Protection Branch. This is in keeping with Justice Krever's recommendation that an active regulator does not rely solely on -- or defer to -- manufacturers for information, expertise and judgment, but seeks its own information.
Mr. Victor Daniel, Co-Chairman, Toronto Food Policy Council: I thank you on behalf of the Toronto Food Policy Council, which is a subcommittee of the City of Toronto's Board of Health. We are directly accountable to the Board of Health. We have our own little growth hormone series happening in Toronto. We have become a little larger since the last time we were up here.
Toronto will be growing more exponentially in the next few years, so food security, food access and food safety is of tantamount interest to the Board of Health and the Public Health Department.
I would like to bring a couple of matters to your attention. We do not only deal with the definition of milk under the FDA. Milk falls under our jurisdiction under the Board of Health in Ontario, and under the Health Protection and Promotion Act. It is the only single food specifically named in that act. We deal with carrots, vegetables, and raspberries that come across from the States once in a while. However, that is a generic term in the Act. Milk is specifically listed as something for us to maintain confidence in and credibility on.
The Board of Health in Toronto now represents 2.4 million people. We work in coordination with the association of local official public health agencies in Ontario, which represents the 38 boards. We are still maintaining a request for evidence that constitutes proof of the safety and the efficacy of this drug. We also wish to look at the socio-economic costs and the economic development of the drug, and how it effects our dairy industry.
We have been involved with this file for approximately seven years now. Our Board of Health held a public hearing in 1994, to which Monsanto was invited. After that hearing, the board decided that the so-called scientific evidence that proved safety was not satisfactory. It recommended to the City of Toronto Council that the labelling issue be brought forward, and that all milk should be labelled, regardless of whether or not the drug was determined to be safe. In fact, we took it one step further -- the City of Toronto supports the mandatory labelling of all genetically engineered food products.
The reason we do this is not so much an issue of safety related to the direct use of the product. It is because of the long-term implications of bringing genetically engineered food products into our food system. If we eliminate labelling, if we eliminate the identification of food products that our consumers and our citizens are exposed to, then we have no recourse to understand what is causing problems if they occur. We would be unable to determine, for example, whether a genetically engineered tomato with an antibiotic resistant marker were affecting sugar content.
As the senators have correctly pointed out, hundreds of new products will hit us shortly. Fortunately, our council has the expertise, and scientists internationally are bringing forward better protocols to understand the implications of genetically engineered food products.
It has been an interesting day today. I was worried before I came here. Now I am really terrified. I must make a report to the board as to what our confidence can be in the ability of Health Canada to deal with this issue. I must make a report regarding the review process. I must make a report on the scientific protocols and the review research on which many of these claims were based. I am here today to tell you that you do not have my confidence -- not one shred of it. I will tell you why.
I fail to understand this, despite the integrity of many of the people here telling us that we need science. They are saying that science must rule, that science must operate, that we need it to create economic development, and to bring in new products and new technology. We agree, but at what point are you prepared to allow the law to function?
We were told that this would be a science-based regulatory process. Our council has engaged within that process. We have looked at review data for human safety and animal safety. We have gone so far as to try to understand dairy cows. That is my job, because I am the hoof trimmer and I am supposed to know about dairy cows as a rural adviser to the council. They listen, and we learn.
The problem in dealing with this is that we all acknowledge that BGH is a production aid. The term "treated" does not really apply. It has a medical point of analysis for licensing, but it is an improper way of having it explained to the public. We have had Monsanto representatives say that it is the same thing. Ladies and gentlemen, it is not the same.
If Monsanto has the nerve to come here and tell us that this drug is the same, then I want them to prove it scientifically. I want them to put it in a peer review journal, and say that they refute the Canadian Journal of Animal Science article that says that the drug does not create 50 per cent more milk production access than natural BGH does.
Our ire is quite intense. It is rather ironic that today was the anniversary of Pearl Harbour. I feel "Pearl Harboured." I can tell you what the admiral said after the attack on Pearl Harbour. He said, "I am afraid we have awakened a sleeping giant." Senators, I can assure you that we are awake.
Do not dare take a misstep on due process on this matter. The Senate is doing an excellent job of bringing these things forward. I have learned a great deal today. Ann Oaks has been a great resource access to me, because sometimes we do not have time at work to make it to the library. If I ask the department for a report, it could be three months before I receive it. If I phone Ann Oaks, I have it in 24 to 48 hours through my fax or email.
We were told that IGF-1 is within normal ranges. I can play this game too. For instance, I want to treat a particular cow who, thanks to her inherited genetic code, produces 2,000 nanograms of IGF-1 per litre of milk a day. If I inject the cow, the same Canadian Journal of Animal Science that Health Canada sent us as proof that there is no problem states that an individual cow's IGF-1 levels can be increased by 200 per cent. Therefore, my cow that produced 2,000 nanograms of IFG-1 per litre will now produce 6,000 nanograms.
The amount of IGF that cows produce varies from cow to cow, and some could have 8,000 to 9,000 nanograms. If I compare one that is not injected at 9,000 and an injected one at 6,000, then, I can say that the injected cow is within the normal ranges. If the drug were for therapeutic use, I would stay with this course. It is not for that, however -- it is a production aid. The fact is that the farmer has the right to inject the cow that produces 8,000 nanograms, and it will now produce 32,000 nanograms. What normal ranges?
In the Food and Drug Act, Division 8 of Part B, B.08.003[S] whole milk is defined as the normal lacteal secretion obtained from the mammary gland of the cow genus Bos, end of discussion. How did growth hormone from a needle get into the cow? A human picked it up. Who is the human? Dairy farmer or vet? What country is he or she from? What are the contractual obligations with respect to dairy farmers in this country? Why is no one asking that? The processors are stuck.
We have a tremendous dairy industry, and it was built through patience, perseverance, and prudence. We could argue all day long that BGH is safe, and I would ask "on what basis?" We could argue that it is unsafe, and I would sit here and say, "on what basis?" How many cows would be injected, and what is the controlling mechanism to prove to me that they are injecting only so many cows, thereby allowing me to establish what the level of IGF-1 would be? You do not have it, because it is up to them. What scientific evidence can you bring me to state that you understand that it is within normal ranges?
The other main concern that we have is why are we looking at a growth hormone in the first place. Under the regulations of the Canadian Milk Recording Board, it states very clearly that no drug or stimulant, including oxytocin, may be used to produce more milk, or to create an abnormal yield of milk, fat or protein. Who rescinded that?
Dairy farmers were directed to support establishing the breeding value of livestock in Canada. Allow me to table a list of extended pedigrees or pedigrees of registration with you. As you can see, every animal has a registration number. That has been the case since 1881 under the Animal Pedigree Act, which is federal law. That legislation states that we are to work toward breed improvement. It does not say breed utilization; it says breed improvement.
Under our own directives, then, the use of hormones for either reproductive use in dairy cattle or as a production agent would not satisfy the requirements of the original database. That would constitute scientific fraud once a farmer did that under those conditions. We brought this up to the dairy farmers of Ontario. We brought this up to Holstein Canada. The atmosphere there is that they are worried about causing a stink over this process, and they are afraid they will lose consumer confidence by fighting for a law that maintains their ability to sustain the dairy industry.
I would like to thank Dr. George Paterson for the openness I have found in trying to deal with Health Canada, because we have been writing them letters for the past year. Apparently, they were good enough to go into the gaps analysis report. You are missing a few that were written since the report's publication, and we will supply them to you.
We have a big decision to make. Can we elevate growth factors in milk to any level we want, even though the law says it should be normal milk? I find it very interesting, and I will bring this case forward. The problem here is definition, standards, and measurements, not safety.
I have not yet understood what you are trying to tell me. Define what I am dealing with. If safety were the concern under the Food and Drug Act, it should say that right out front, but it does not. Instead, it defines milk and the kind of animal that produces it.
If it is just safety then, I could argue that milk from a genetically engineered cow containing human protein is safe for milk, and therefore is fit for human consumption. It would be a violation under Codex principles regarding false and misleading advertising of products, however, and of our own Ontario Consumer Protection Act, because it is not milk from a cow. It is not milk from the genus Bos, it is a genetically engineered organism. It would be safe to eat, would it not, if safety were the issue?
We do not understand where this regulatory process is heading. We believe firmly that it would be best to let Health Canada have a chance to think before products are shoved at them under the contradictory terms of agreements that exist within our country. If these agreements are here, then stand by them. If the farmers want to repeal or rescind them, or if we want to change the definition of milk under the Food and Drug Act, then take it to the floor of Parliament, let them debate it, and let the Senate have the final word on the issue. You do have the final word, do you not?
Ms Ann Oaks, Ph.D., Fellow of the Royal Society of Canada: I am a plant physiologist. I have had a fairly successful career as a scientist at McMaster University, and more recently at the University of Guelph.
The operative word I believe is "physiologist." Physiology is how cells or organisms work, so it does not really matter in this sense if you are looking at cows or corn. If you are looking at a special kind of experiment, you may add a substance. One major kind of experiment that physiologists do is that they add a substance to the organism and look for changes in metabolism. In this instance then, recombinant growth hormone is a substance that we are adding to a cow. What changes do we expect to find?
I first heard of this problem of the recombinant growth hormone being introduced into Canada on a CBC program, where a farmer from Prince Edward Island said that we do not need the growth hormone as we have good milk products already. Monsanto responded by saying that there is no problem with the growth hormone, that it is a natural substance. I saw red at that point because hormones added to living systems can have a different response, depending on the age of the organism and the amount of the substance to be added.
Listening to the deliberations today, I begin to see the problem that you have. We have listened to two groups of people talking about cows that have been treated with the growth hormone. The first group said that the cows are sick and the second group said that there is no problem. How do you come to a correct answer?
In a way, Monsanto has helped us with the correct answer. If you look at the situation where there might be a greater incidence of mastitis in cows treated with the hormone, Monsanto's people used a set of data that said there was no difference. They gave this raw data to a group of people working in England who looked at the statistics and said that there is a significant increase in the incidence of mastitis in the treated cows.
Monsanto, at that point, if they really believed in their results, should have let everyone have their raw material, let everybody do the statistics, then we would know the correct answer. I believe from this example that we know that Monsanto is hiding information.
Let us say that when cows are treated with the growth hormone they have looked to see if there is more recombinant bovine growth hormone in the milk of the treated cows. There probably is not. It is probably within the statistical level. Perhaps the problem is not the growth hormone itself but some secondary product that might be produced as a result of the treatment of the cow.
Then we have the insulin growth factor 1, where there could be up to a 10-fold increase in this compound in the treated cows. What do we know about insulin growth factor 1? Epidemiologists tell us that there is a correlation with the amount of insulin growth factor 1 and the incidence of certain cancers. That is a correlation experiment. It tells us that we should be doing more direct experiments to look at this point. Other scientists using tissue culture systems have shown that the insulin growth factor 1 results in more cell division. This is what we also have if we are inducing cancer.
Let us say that the story is not complete with insulin growth factor 1. We have not done the long-term experiments. In humans it might take 40 years for the cancer to develop. In test animals, they were talking today about three years for cancer tests. We need long-term tests, which we have not had.
The third point I would make, and I feel that people are missing this point, we have added a growth hormone that is changing the metabolism of the cow so that the cow makes more milk. What other changes do we have in the cow? We do not know what to look for. This is what a physiologist does. We do not know what to look for but we must have some way of measuring this compound X to see if it is there. We can use whole milk instead of insulin growth factor 1, or growth hormone, and use the whole milk from treated cows on test animals for long-term experiments and see if there are any long-term effects. These experiments have not been done.
The other point is with science. If it is scientific problem, we can come to a correct answer. If it is a philosophical problem, we can come to consensus. We should not be discussing whether treating the cows with the recombinant growth hormone is good or bad. If there is still a great deal of discussion, it means that we need to get back to the drawing boards and do the experiments.
That is the point I wished to make.
Senator Whelan: There is so much that the panel has said that I agree with.
Do you know a man by the name of Dr. Bill von Meyer?
Ms Oaks: Yes.
Senator Whelan: I have a document from him in which he outlined almost what you have said about the growth promoting hormone IGF and how there has never been any real testing of this. Since 1990, they have had the opportunity to do this testing. He is concerned about the same thing you are talking about.
Have you exchanged papers with him?
Ms Oaks: The last time the bovine growth hormone was considered we were in touch with each other, but we are not regularly in touch with each other.
Senator Whelan: Are you not also a professor emeritus with McMaster University?
Ms Oaks: Yes, but 10 years ago I took early retirement. McMaster University has a medical faculty that did not appreciate the work of plants, so I moved to Guelph.
Senator Whelan: They do not believe that plants are living things?
Ms Oaks: They did not feel that they had anything to do with people's health.
Senator Whelan: You and I both disagree with them then, do we not? I believe that healthy plants make healthy people.
I now wish to address a question to Mr. Daniel. Who did you mean that you did not have much confidence in, the people of Health and Welfare Canada?
Mr. Daniel: I am trying to figure out how we are dealing with a complete regulatory collapse here. It seems that the Department of Health is being left vulnerable to products that are not really relevant to the prime directives that some sectors of our society are dealing with. The dairy farmers already have the technology and the prime directive to develop animals, they must design and develop animals capable of producing a product worthy of human consumption in the environment that benefits us and increases the farmers' profit.
They have said they would do it by breeding value. Dairy Farmers of Canada supports that point. The farmers have been arguing in a backward fashion. They have been saying that you are either for or against the hormone. No, that is the wrong way of looking at it. Look at it this way: Are you for or against maintaining breeding value and understanding that value? If that is the case, then the hormone is not an issue and you have wasted a tonne of scientific capital and the taxpayer's dollars evaluating an unnecessary product, period.
Why should George Paterson need to put up with half the nonsense that goes on trying to fine-tune communication lines between myself, Monsanto, you, the public and the rest of the department? Why is he dealing with this? I am sorry, I have a bottom line, that is why my confidence is not here.
Where is the communication within the whole structure? We are a whole group. We are a whole people. We are not part of something else. If I am taking care of your arm today, and you ask what about the rest of me, would I say that I am sorry, that I am not qualified to handle that? I know that all of you is needed in order to move your arm. That is why I am losing confidence here. Where do we turn?
We have had this discussion and we got the support of the Nurses' Association of Ontario. Over 50 organizations support our position. We will support a science-based regulatory process within our law as we understand it, and our laws are clear on this matter. Why are we dealing with it is our question.
Senator Spivak: Monsanto wants us to deal with it.
Mr. Daniel: They have a legal right. I believe I am correct in this. Once it has been sent in, they have the legal right to ask what is going on here. We did submit this. We do not have the same laws here as they do in the United States vis-à-vis the way they do and view things in Europe.
Where is my science? At what point does Canadian law and Canadian policy become relevant? You are telling me what the Americans are doing. I have a great deal of respect for what they are doing. Thanks to their research and development, some of which I believe is a little weird, I get a chance to think about how I could apply that, or could I or should I. The Europeans are doing some things differently. I say that is nice. I like Camembert cheese, and I cannot get that here that well.
Do you understand where I am coming from? You talk about harmonizing the regulatory process, but to what end? Mediocrity? Really, you say you wish to harmonize, be the same as everybody else. I do not wish to be the same as someone else; I wish to try and be better than what I can be. That is where I am coming from.
Senator Whelan: I referred to the Canada-U.S. Agriculture Trade Release, where they tell about all the things they have agreed to here. It says that on issues related to veterinary drugs, both countries agree that their regulations produce essentially equivalent results and maintain a high level of public safety.
It sounds like they are suggesting that we will have the same rules and regulations, systems and procedures that the United States wants. Is theirs better than ours, or worse?
Mr. Daniel: I believe that you are getting into a generic point. I believe there are some sectors, especially in food labelling, in which the U.S. is superior. They have new mandatory labels on cans; everyone must do it the same way. There is no colour distortion, and it can be easily read. We are not doing that. We are all over the place. I believe they are advanced in some areas but we do many things better.
Senator Whelan: I do not have much confidence in their system. Dr. von Meyer worked with one of the biggest research science groups in the United States, and what he says about what they are doing makes it more shocking.
Dr. Brill-Edwards, I find your evidence even more discouraging. Is it just Health Canada, or are all of our federal departments running amok?
Ms Brill-Edwards: Senator, the evidence shows very clearly that this is a government-wide problem. We have evidence of suppression of scientific information in the Department of Fisheries and Oceans directly contributing to the loss of the cod fisheries off the coast of Newfoundland. We have evidence in other departments. The point is that we must start the clean-up somewhere. I cannot think of a more urgent place to clean up the culture of deception and decadent loyalty than where it bears on health and safety.
Yes, it is a government-wide problem, but the urgency for the clean-up is with health issues.
Senator Whelan: I have always been a strong believer that with good food, good nutrition, et cetera, we can save billions of dollars in health care.
Ms Connors: Registered nurses are educated in the social determinants of health. It is not enough to have hospitals and physicians providing care in an acute care setting once people become ill. We must prevent illness. It is chilling to realize that if the proper regulatory mechanism does not exist for Canadians, we will create illness rather than prevent it. The precautionary principle must be first and foremost. As Mr. McBane said, an ounce of prevention is worth a pound of cure. It is absolutely true that we must keep people well through safe food, drug products, medical devices and blood. Ultimately, while we are talking today about one very specific product, my concern as a nurse covers the gamut. That is why the recommendation is more far-reaching on the issue of studying what is going on in the Health Protection Branch.
I think of Ralph Nader and the Ford Pinto. I think Canada could be sitting on several Ford Pintos that will blow up in our face if we do not ensure that the Health Protection Branch effectively does the job it was established to do; that is, utilizing the precautionary principle as the first line of defence in protecting public health and safety.
Mr. McBane: On the question of food safety, if you study the minister's performance report you will not notice the cuts in scientific food safety research. It is being hidden. That research has been cut in half. I am speaking of essential food safety preventive measures like detecting toxins in our food. When I asked scientists why they are being cut, they told me it is because when they find a problem the industry phones the Prime Minister, the Privy Council and the minister. The simple solution is to get rid of the labs.
The long-term impact on the health system will be enormous.
Senator Robichaud: I have to disagree with what you are saying.
Mr. McBane: I can give you the evidence from the minister's report on the budget of the food safety program. I will table that with the committee. The cuts in safety are documented in the minister's report. I can give you a detailed description of the projects that have been cut.
The irony is that the Department of Health claims to be building a new system based on evidence. It is called evidence-based decision making. They are getting rid of their scientists as fast as they can. The question is: What kind of evidence? Is it the kind of evidence that Dr. McLean flew in from Australia to give? Our evidence is in-house and we should be keeping it in-house.
Senator Spivak: I do not know whether I agree with your recommendation for another inquiry. We already have a very good inquiry. The Krever commission pointed out many things.
We have all kinds of drugs coming up. Changes are coming because the Health Protection Branch sees that they need change, but their change seems to be going in the direction of a faster approval process, risk management, and that sort of thing. Those changes will, I think, mean changes to the Food and Drugs Act.
Most of the cuts were, of course, prior to this minister. You have to look at these cuts in the context of what was happening in Canada.
What should we recommend that would be feasible? The Food and Drugs Act is a good act and before all of this happened, the Health Protection Branch was functioning adequately and Canada had a great reputation. We are being told that we have to change. Not all change is good. I hate it when people say that we must change.
In the face of what is happening, how do we communicate? It is also a matter of values. If you think that the answer to all our troubles is more drugs, you will be interested in a faster approval process. We do need drugs, but how many do we need?
What would you suggest we say in our recommendations regarding the changes to the Food and Drugs Act that are coming down? We have been assured that industry should not be the client. But what changes should we suggest, within the processes of the Health Protection Branch, to ensure that industry is not the client?
We could call for a public inquiry, but I am not sure that would be the answer. Furthermore, I am not sure that it would be listened to. Can we make more specific recommendations? This may be something for all of you to consider and get back to us on.
How should we look at the change that is certainly coming? Should we be opposed to changing the Food and Drugs Act? Should we be suggesting different procedures within the Health Protection Branch?
Dr. Brill-Edwards: You have offered us the option to respond now and to respond later. I will take the opportunity to do both. I should like to make some comments immediately.
The problem that we witness today, after nearly 20 years of deregulation in Canada and around the world, is that there is neither the political will nor the resources -- the staff or the expertise -- in the department to properly uphold the Food and Drugs Act as it exists.
Recommendation number one must be that regardless of what is in the act, it is no protection if it is not enforced. The pendulum of deregulation has swung too far, and we must come back to a supervised, evidence-based enforcement of the Food and Drugs Act. Beyond that, we must move on to any modernization that may be necessary.
Second, because we will have more products coming up for approval and because we will not have more resources to deal with that, the privilege of secrecy that has heretofore been accorded to manufacturers must be dropped. If we do not have sufficient reviewer resources to allow reviewers adequate time to review material in depth, then there is no way that material should remain secret and unavailable to anyone else who may choose to take the time to review it.
A very good example was stated here today of the 90-day rat study. In Canada, someone fought for the privilege and the right to do their job, to apply due diligence and to look at that report properly. In the U.S. someone was forced to look at that report in a summary form that did not tell the full story about the safety issues. We see the danger of leaving these reports behind closed doors when we do not have the staff to ensure that we are going right down to the fine detail.
Senator Spivak: Do you think the Food and Drugs Act should be changed?
Dr. Brill-Edwards: I think 100 per cent of our effort in the next few years should go into enforcing the act and restoring an atmosphere of due diligence in the department.
Mr. Daniel: I am on a committee established by a federation of national consumers in Quebec, and we are dealing with a report on biotechnology and its solutions. Health Canada is involved, as is the Food Biotechnology Communications Network and Laval University. Since I am the person who will be drafting the proposed mandatory food labelling guidelines, I should like to let you know that we will submit that to the Senate.
We need to improve the Food and Drugs Act. However, it needs to have a solid basis from which to operate so we can bring in new designs and ideas. We need to progressively move ahead with it while maintaining the statistical base of a product we understand.
Senator Spivak: Our goal here is to restore the confidence of the Canadian public -- whatever confidence has been lost -- in the Health Protection Branch and to see that it operates as I presume it operated in the past before the cuts. I am stating my own view, but I think it is shared by other committee members.
Ms Connors: Appendix 6 submitted by the Canadian Health Coalition contains seven recommendations. I think there must be a restoration of the Health Protection Branch budget for the food and drug safety programs. You cannot expect these people to do it unless they have labs and personnel to do so.
We must terminate the cost-recovery programs in the health protection system. He who pays the piper is calling the tune, and we have to stop that. If Canadians want a safe health protection system, then we pay for it and do it proudly. I am quite prepared to do that, and I think many of the people I am here representing want that kind of integrity in the system.
Senator Chalifoux: We end up looking at two issues here, and I would like to get back to the main issue of rBST. I wish to direct my questions to our eminent scientist.
Many side effects have been identified in the labelling of rBST in the states, such as mastitis. The list goes on and on. In your opinion, would any of those side effects eventually affect humans, resulting in abortions and deformed fetuses?
Ms Oaks: It is hard to say what the long-term effects would be. Given that there are those side effects in the cows, it means that the metabolism has been changed. If we consider that one of those side effects is stress, stress to high temperature in particular, then the cow is probably making other poisons in itself or other bad things, which could get to the milk. This is what I meant by my third point with respect to the unknown compounds that have not even been reviewed.
I would say that the cows are getting a big dose of the growth hormone, and this could be what is causing abortions or abnormalities with the fetuses. I would not expect such gross effects in humans, but I would be worried about long-term effects, such as cancer, for which we could be testing.
Senator Chalifoux: I know that our Health Protection Branch has been under a lot of criticism. Much of that has to do with growing pains and the changes within our government system. I have many questions and many inquiries I would like to make as well, but in the meantime, we must continue with this issue of rBST.
What do you see as a process to recommend to the Health Protection Branch in doing more in-depth studies on rBST?
Ms Oaks: If you have training with animal systems, there are tests laid down for cancer or for long-term changes in the cells. These are the kinds of tests that the health protection scientists should do or could farm out. That is one of the changes with which I feel very uncomfortable. Universities cannot do what the health protection agency is doing. We have people there for three or four years getting a degree. The Health Protection Branch has well-trained and well-qualified scientists who can answer these questions, and they should be protected. They know the kinds of experiments they should be doing if the money and the equipment are there.
Dr. Brill-Edwards: I neglected to mention two documents that I wish to table with the committee. The first shows evidence that the attempts to create a special possibility for the marketing of rBST in Canada under the conditions of so-called conditional approval were not limited to the early years, as stated unequivocally by the HPB staff. There is a document here from the department actually authored by Ian Alexander, who told us earlier today that there were no such efforts recently. This document is dated May 16, 1997. It speaks to a discussion between himself and others concerning whether conditional clearance could be available to a veterinary drug in Canada.
The second document pertains to Dr. Losos' claim with respect to Dr. Yong's 1990 letter stating that the submission for rBST was in compliance with the food and drug regulations regarding human safety and that he had no responsibility for it. In fact, there is a document dated September 25, 1997, from Dr. Paterson to Mr. Mowling of Monsanto, copied to Dr. Losos. It specifically makes reference to the previous letter and its legal validity. I should like those to be on the record.
The Chairman: I would like to thank our witnesses for appearing here today. Their presentations were very thorough, and we appreciate that.
The committee adjourned.