Proceedings of the Standing Senate Committee on
Agriculture and
Forestry
Issue 35 - Evidence - Afternoon sitting
OTTAWA, Monday, May 3, 1999
The Standing Senate Committee on Agriculture and Forestry met this day at 2:04 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 Eugene Whelan (Deputy Chairman) in the Chair.
[English]
The Deputy Chairman: Honourable senators, with us this afternoon is Dr. Leonard Ritter. Dr. Ritter has been asked to appear this afternoon to give testimony on his personal experience in working with and on international health advisory panels.
Please proceed, Dr. Ritter.
Dr. Leonard Ritter, Individual: Mr. Chairman, by way of background, I joined Health Canada in 1977 under the auspices of a national scholarship after completing my formal studies at Queen's University. Over the course of the next several years, I held a number of positions in that department. The one most relevant to your considerations here today was that I was appointed director of the Bureau of Veterinary Drugs in 1990, a position I held until 1993 when I left on June 1 to become the first executive director of the Canadian Network of Toxicology Centres, with administrative headquarters at the University of Guelph. At that same time, I was jointly appointed to two faculty positions at the university. I am a tenured professor in environmental biology and an adjunct professor in biomedicine.
Although I do not appear here today entirely voluntarily, senators, I will do my best to help you insofar as I can.
I preface the comments I will make with two specific limitations. The first is that I am not here representing any UN panel. The second is that I am not here representing any branch of government. I am here only in my own capacity. To the extent that I can help the committee with its deliberations, I will do my best.
Senator Kinsella: Perhaps, Dr. Ritter, you could help me to place in the proper context or situate within the international community Codex Alimentarius.
Mr. Ritter: "Codex Alimentarius," for those of you who may have had the opportunity to study Latin, refers to the words "food standard." The Codex Alimentarius is an arm of the United Nations. It is an organization within the UN responsible for establishing food standards internationally.
Senator Kinsella: Is it part of the FAO?
Mr. Ritter: Administratively, yes.
Senator Kinsella: Did a resolution of the Food and Agriculture Organization of the United Nation create the Codex Alimentarius? Does Codex report back through the FAO?
Mr. Ritter: I would be offering you an opinion, senator. I am not certain of the absolute, correct answer to your question.
The Codex Alimentarius is physically housed within the FAO. There is certainly a relationship with the FAO and with the United Nations system. However, as to the specific reporting relationship, I could not tell you.
Senator Kinsella: What impact does the standard-setting done by the Codex Alimentarius have around the world? How important is that?
Mr. Ritter: I should like to think that it is very important.
I will read a couple of paragraphs from a document that will clarify those relationships for you. I am reading from a joint FAO-WHO Food Standards Programme publication. The one I am holding happens to be from 1993 because it the one I could put my hands on quickly in preparing to come here today. The same introduction appears in every volume they issue. I will make a copy of this document available to the committee. In isolating these paragraphs, I hope I am not misrepresenting the thrust of what is intended. The document states:
The Codex Alimentarius Commission is the international body responsible for the execution of the Joint FAO/WHO Food Standards Programme. Created in 1962 by FAO and WHO, the Programme is aimed at protecting the health of consumers and facilitating international trade in foods.
The Codex Alimentarius...is a collection of international food standards adopted by the Commission and presented in a uniform manner. It includes standards for all the principal foods, whether processed or semi-processed or raw. Materials for further processing into foods are included to the extent necessary to achieve the purposes of the Codex Alimentarius as defined. The Codex Alimentarius includes provisions in respect of the hygienic and nutritional quality of food, including microbiological norms, provisions for food additives, pesticide residues, contaminants, labelling and presentations, and methods of analysis and sampling. It also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures.
The introduction to Volume 3 of the Codex Alimentarius states:
This volume contains the Maximum Residue Limits for Veterinary Drugs and other recommendations adopted by the Twentieth Session of the Codex Alimentarius Commission based on the advice of the Codex Committee on Residues of Veterinary Drugs in Foods. The Maximum Residue Limits are consistent with the recommendations of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
I would draw your attention particularly to the next statement I am about to read because I think it may answer many of your questions in one sentence.
The JECFA is composed of independent scientists who serve in their individual capacities as experts, but not as representatives of their governments or organizations. The goal of JECFA evaluation of veterinary drugs is to establish safe levels of intake by setting Acceptable Daily Intakes (ADIs) and to develop maximum residue limits when veterinary drugs are used in accordance with good veterinary practice.
The joint expert committee structure within the United Nations system is composed of individuals who are identified for their internationally recognized expertise in a particular discipline. Typically, they are invited to prepare a review or a brief ahead of the consultation. They are required to be present at the consultation where that issue is to be discussed. The joint expert committee as a whole then deliberates that review and, ultimately, comes to a conclusion as to the interpretation of the particular issue.
The recommendation of the joint expert committee is then made to the appropriate Codex committee. In this particular case, the recommendations of the Joint Expert Committee on Food Additives, which has no national jurisdiction or representation, are made to the Codex Committee on Residues of Veterinary Drugs in Foods, which has been hosted administratively by the government of the United States for the last 10 years or so.
The Codex Committee on Residues of Veterinary Drugs in Foods can adopt the recommendations of its expert committee or it can send the issue back to the expert committee for further study. There are all kinds of permutations and combinations. Ultimately, the Codex committee can make its recommendations to the Codex Alimentarius Commission, which in turn may or may not adopt a recommendation of its committee.
Senator Kinsella: What is the status of a decision by the Codex Alimentarius Commission?
Mr. Ritter: Earlier this morning, Senator Spivak referred to the fact that we sometimes need to invoke the help of lawyers who are experts in international trade. What I offer you is an opinion, although certainly not an expert one.
With the globalization of world trade, part of the package is the adoption of internationally established food standards, including residues of veterinary drugs. If a veterinary drug residue limit is adopted by the Codex Alimentarius Commission, it is my understanding that member countries of the organization must either adopt that standard or reject it on the basis of technical grounds. I do not think a participating country can reject an adopted standard as a means of creating a barrier to trade. There are certainly instances in which a participating country has rejected a particular standard and has defended that rejection on the basis of a technical or scientific issue. However, it is my understanding that a country rejecting a standard would have to make that test or, ultimately, perhaps face sanctions within the World Trade Organization.
Senator Rossiter: Dr. Ritter, how are the members of JECFA selected? Who recommends them? What sort of term do they have?
Mr. Ritter: Again, I am offering you my best opinion, senator. Whether or not it is entirely accurate, I cannot tell you for sure. It has always been my understanding that members of expert committees are selected on the basis of their recognized international expertise on the topic that the expert committee will be deliberating at that particular session. Generally speaking, the request or the identification of such experts from the international community comes from within the WHO secretariat itself or, in the case of residues, from the FAO secretariat.
In the case of veterinary drugs, the joint expert committee consists of two components. The first is a group that looks entirely at issues related to toxicology or human safety. The other is a group that looks entirely at issues related to environment chemistry. We meet at the same time and in the same place but independently of each other. We do that because we want to make sure that our conclusions with regard to toxicology or human safety are not influenced by the perception of a need to establish a certain residue limit. Typically, these deliberations take two weeks. During the course of the deliberations, we meet physically at the same venue but entirely separately for about 80 per cent of the consultation. We get together at the end to see if the toxicology conclusions can be consistent with the requests for maximum residue limits.
Senator Rossiter: Would it be wrong, then, to presume that they must indicate any conflicts of interest that they might be subject to at that time?
Mr. Ritter: Two conditions are imposed on us before we can participate in a deliberation of the committee. First, we must make an explicit declaration of conflict, if one exists. That requirement is included in every letter of invitation that is issued by the secretariat. Second, the invitation states explicitly that you are not invited as a representative of any organization or government but as an individual with recognized expertise in the particular discipline. If individuals are unable to meet those two conditions, that is, if they feel that there is a potential for conflict, either real or perceived, or, alternatively, if they feel that because of the nature of their work they are unable to come as independent scientists, then they would not participate. A failure to meet either of the conditions would be sufficient to not have an individual participate.
Senator Rossiter: I presume "organization" would include a corporation?
Mr. Ritter: That is right. There is it no industrial representation on the committee. That has been a long-standing rule since the dawn of time.
Senator Spivak: Dr. Ritter, thank you for coming here this afternoon.
In your correspondence with the committee, you indicated that the committee has been misled in certain respects and that you have information that clarifies those areas in which the committee has been misled. Speaking personally, it was for this reason that the committee insisted upon your appearance.
How has the committee been misled? What is the information that would be valuable to us?
Mr. Ritter: Had I realized that at some time down the road I would be compelled to appear, I would have chosen my words differently so that I would not have been compelled to do so.
Senator Spivak: You are an extremely important person. I wish to thank you for complying with our request.
Mr. Ritter: As I mentioned earlier, although I certainly am not here voluntarily, I am not unhappy to be here.
Senator Spivak: Yes, that is quite clear.
Mr. Ritter: Let me offer you some commentary with regard to the comments I made to Mr. Armitage in correspondence.
In December of 1998 I was provided with an extract of a so-called "gaps report" that had been prepared within Health Canada. I should say that I have never seen the entire document. It came to me from a Mr. Hank Schriel who sent it to me because it was apparent that the document had been prepared by staff at Health Canada and that it was to be released publicly. Because I was named in a number of places in the document, he was asking, I gather from a legal point of view, as to whether or not I would object to its release.
I communicated with him formally on December 3, 1998, indicating that I vehemently opposed its release -- not that I expected that that would have any impact and, indeed, it had none.
I understand the committee has had access to the entire report, which I have not. I wish to read from page 502, one of the pages that I was provided, which sets out a statement credited to Shiv Chopra. It states:
By the way, you should also recognize that there are other problems with the JECFA report. There are other issues. Ritter is a member there and there is all kinds of other anvils into this.
Senator Spivak: Are you quoting now?
Mr. Ritter: I am quoting directly from the document that was provided to me by Health Canada.
Mark Feeley is then quoted. I should add that, to the best of my knowledge, I have never even met Mark Feeley. He is quoted as having said:
As far as Health Canada is concerned, they will never get rid of Ritter as being a member of JECFA.
Shiv Chopra then responds:
No, no, that is not correct. It is Health Canada that has been sending Ritter there, okay. And it should not be so.
When I read this statement in December, my initial reaction was that the most benevolent thing I could say about it was that it is wrong. I have not been with Health Canada since 1993. Health Canada does not direct an invitation to me that they receive from the joint expert committee. I have had no contact with Health Canada with regard to my participation on the expert committee, with the exception, perhaps, of one year that I actually did some work with a Health Canada Bureau of Veterinary Drugs staff member in preparation for a consultation. That was in 1994, I think, and there has been nothing since then of any kind or at any level.
When I read that report, I had the impression that the committee might, quite properly, have come to the conclusion that, somehow or another, Health Canada is nominating me to these committees, that the invitation is directed to Health Canada and that they are taking advantage of that invitation to ensure my continuing participation in the committee. None of that is true. I do not know what value or what weight the committee would place on the statement.
It should like to mention a number of other statements as well, if I may. What I have here is some broken text. I do not know if that is because the transcripts were incomplete. For example, there is a statement here credited to Shiv Chopra that says:
Sol Gunner did that.
Gérard Lambert responds:
It was approved.
Shiv Chopra responds:
There were witnesses.
Senator Spivak: I am sorry, Dr. Ritter, but this is out of context. To what is this referring?
Mr. Ritter: I do not know. That is my point. Let me read you a statement on page 503 that is not out of context:
I mean JECFA cannot, they cannot go to Monsanto and say who should go to the meeting. JECFA goes to the food directorate and says who do you think is appropriate. So the decision to send this bozo Ritter has to be addressed because --
And then my transcript stops.
Senator Spivak: I wanted to get into some other questions but you have raised this directly. Is this the extent of the misinformation that you are talking about?
Mr. Ritter: Yes.
Senator Spivak: I do not know, but I think the basis for that particular comment might be the fact that there is a memo that talks about a telephone call from Dr. David Kowalczyk of Monsanto to Dr. Ian Alexander, not quite suggesting but insinuating that you be reappointed. That memo is there.
Mr. Ritter: I am unaware of it. What is the date?
Senator Spivak: The date of the memo is August 27, 1997. I do not know whether that is privileged information for the committee only or whether it is public. That is probably where that indication came from. This has nothing to do with your individual actions, but it would be disconcerting if someone from Monsanto were phoning someone in Health Canada and saying, "We think this is the person who should be on there." Can we leave that for a moment? I should like to go on to other things.
Mr. Ritter: Quickly in response, I should point out to the committee that I was unaware of the existence of that. Did you say that it was a memo or a record of a telephone conversation? I have never seen it.
Senator Spivak: It is a memo to someone about a telephone conversation.
Mr. Ritter: Not only have I never seen it, but in fact the reference that you make is surprising to me, to say the least. The invitations that I have received over the years from various committees, not just this one, within the WHO organization are directed to me from the WHO.
Senator Spivak: All right. Perhaps we can leave that for a moment because there is no way of getting into it.
I wish to continue the questioning with regard to JECFA and the Codex Alimentarius. First, with respect to Codex Alimentarius, as I understand, it is composed mostly of representatives either from industry or from government and there is one consumer person. Am I wrong about that? Could you comment on how the representatives at the Codex Alimentarius are chosen?
Mr. Ritter: My recollection is that the Codex Alimentarius Commission is made up of delegations appointed by national governments. Governments may, at their discretion, depending on the issue to be discussed at a particular commission meeting, appoint whomever they choose as a member of their respective national delegations. That may include representation from industry, from academia, from trade organizations, from lobby groups, from NGOs and so on. However, it is my understanding that the invitation is directed to national governments.
Senator Spivak: Right. And they are there as representatives of those governments, unlike the JECFA.
Mr. Ritter: Correct.
Senator Spivak: It is interesting, and this is how this first came to my attention, that at the very time that Health Canada was looking at a further review of rBST, our representatives at the Codex Alimentarius were voting against further examination of rBST. That is an interesting kind of mix.
Mr. Ritter: To be clear, I wish to say that I left government informally, or formally, if you like, in June of 1993. Since that time, for reasons that are entirely apparent, given the composition of the commission membership, I have not attended a commission meeting. The last one that I attended was in 1992 when I was still a public servant at Health Canada.
Senator Spivak: Before we leave this issue of the misinformation about your attending JECFA, I take it, then, that you have never done any work for Monsanto?
Mr. Ritter: Never.
Senator Spivak: Have you ever done any reference work?
Mr. Ritter: No.
Senator Spivak: All right.
Senator Kinsella: The Codex Alimentarius Commission is made up of representatives of member states; is that correct?
Senator Spivak: Yes.
Senator Kinsella: Dr. Ritter, could you tell us how many member states constitute the Codex Alimentarius?
Mr. Ritter: No.
Senator Kinsella: Would it be around 30 member states?
Mr. Ritter: No, it would be far more.
The Deputy Chairman: I can give you that information. At the last session they had in 1997, there were representatives from 86 countries, and they had 444 participants.
Senator Kinsella: Would you be able to tell us the numbers with respect to the JECFA expert committee, with members who are serving in their personal capacity?
Mr. Ritter: I anticipated your question and I brought along some information that I will leave for the committee. I brought along the membership of two recent expert committees that dealt specifically with issues related to veterinary drugs. One was a committee convened in February 1999. That particular committee, including the secretariat, included 39 members. By way of comparison, the 1997 expert committee, convened in September of that year, included 32 participants. That number is more or less representative of the sort of participation we see at a typical meeting.
Senator Spivak: Back to the Codex Alimentarius, perhaps you can give us some information regarding this. Are there the same conflict-of-interest provisions surrounding the Codex Alimentarius? At a meeting, Mr. Robert Ingratta was listed as either chair or member. He was part of the delegation. At the same time, he was a lobbyist for Monsanto. I take it that there are no conflict-of-interest rules. I would also say that many members of the federal Food and Drug Administration of the United States, often people who go back and forth with Monsanto, were also represented as part of the American delegation. Is that correct?
Mr. Ritter: The short answer is that I do not know. However, when I was part of the Canadian delegation in 1992, it was crystal clear that I, as an individual, was guided by the conflict-of-interest regulations that were imposed on public servants.
Senator Spivak: At Health Canada.
Mr. Ritter: Yes. If Bob Ingratta was a member of a Canadian delegation at some meeting --
Senator Spivak: He was.
Mr. Ritter: Then I think, with respect, the question is more properly directed to the head of the delegation who would have appointed him.
Senator Spivak: That is right. I just wanted to know your information. You are saying that the decisions of the Codex Alimentarius are then binding on member countries. It was my impression that they are not yet binding but that they are moving in that direction because of decisions of the WTO dispute settlement mechanism which cites the Codex Alimentarius as an indication. Is that correct?
Mr. Ritter: If I said "legally binding," I apologize. I did not mean to use the term "legal." In fact, I think I prefaced my comments by saying that I am not a lawyer and I am not here representing any WHO, WTO or United Nations panel. My understanding is exactly as you have just articulated; that is, that standards established by the Codex Alimentarius Commission are used as reference points by the WTO in arbitrating disputes between countries. The extent to which those standards that the WTO may refer to have legal meaning is a matter for interpretation by an appropriately qualified trade lawyer, which I am not.
Senator Spivak: I have two more questions with regard to JECFA. There have been criticisms of the JECFA operation. One of the criticisms, given to us by Dr. Lambert here this morning, is that a report that showed that IGF-1 was passed through was not even mentioned.
Apart from that, there were JECFA documents leaked to Monsanto with relation to "subject under discussion." That, I understand, is completely against the oaths that people take or the documents they have to sign with regard to conflict of interest.
What can you tell us about that? We know that it actually happened. What is the culture there that allows that to happen? Do you agree that this is morally reprehensible, not to mention not entirely kosher?
Mr. Ritter: I would agree that it is not entirely kosher. I would agree that it is entirely reprehensible. The expert committee includes people from many different nationalities. We are all raised with a different set of standards for what is respectable personal conduct.
On a personal level, during the course of deliberations on a given issue, whether I am involved with it directly or whether it is a matter before the panel for consideration at a particular meeting, I have decided to avoid any direct discussion with any of the industries that may be affected by the outcome of that deliberation. To be quite candid with you, I am more concerned about the perception than the reality. Even something as seemingly innocent as dinner could be perceived as entirely inappropriate.
Senator Spivak: Especially if they pay for the dinner.
Mr. Ritter: It would be very unfortunate if someone really could be influenced for the price of dinner. Rather than worry about it, my personal choice is that the nature of the work is so important and that the world's eyes are watching so closely, that it is a practice that I do not condone and one in which I do not participate when involved in WHO work.
If information were leaked to Monsanto with regard to an issue being considered by the panel, I was not a party to the negotiations surrounding that, or what sanctions were implemented as a result of it, or what the circumstances were under which the disclosure took place, so I cannot really help you.
Senator Spivak: We know that personnel move quite frequently between different agencies of government, the corporation and these international bodies. How would you rate the influence of Monsanto, direct or indirect, or any other corporate entity, on the work of the JECFA, given what has occurred? Are they squeaky clean? Is there influence? What is the story?
Mr. Ritter: I am old enough never to offer anyone any absolutes on anything. In my youth, I was more inclined to offer all kinds of absolutes. I would say that the influence that any corporate organization can exercise over the deliberations of an expert panel is something approaching nothing.
Senator Spivak: Because many scientists are not funded by government, they have no choice but to resort to industry grants. For example, does your non-profit centre have any industry grants?
Mr. Ritter: Yes.
Senator Spivak: Are they from Monsanto?
Mr. Ritter: No.
Senator Spivak: I do not blame the scientists. They are forced to do that. However, you can see how that influence could enter into the decision-making process, which would be of huge benefit to those particular corporations.
Mr. Ritter: No.
Senator Spivak: Are you saying that in your opinion, even though these matters have occurred, even though studies have been omitted which are key to a decision, even though confidential influence has been leaked to the party that has the most to gain from this, there is no influence of any corporate entity on the operation of this very important body, the JECFA?
Mr. Ritter: As I indicated a little earlier, every member of every expert committee is required to sign a declaration with regard to a conflict. If a member of an expert committee may be in conflict because he or she receives funding from an industrial organization that is represented in terms of a product or technology at the meeting, that individual is required to make that declaration and to remove himself or herself from those deliberations. If you are asking me whether they all do it, I can only say that I do and I would certainly expect that all others do the same, and that is certainly the expectation of the WHO secretariat. There is no question in my mind that if it became evident that any member of any expert panel did otherwise, they would certainly not be asked to serve again. This is a very important consideration for the expert panel. It cannot function if it is not perceived to have honesty and integrity.
Senator Spivak: Thank you very much, Dr. Ritter. Your information has been helpful.
Senator Robichaud: How does rBST happen to come before JECFA?
Mr. Ritter: Nominations for compounds to be reviewed by the expert committee process almost always come forward from a national government that attaches a priority for one reason or another to a particular compound, or are referred by its representative Codex committee, again because there is a perceived need, either because of international trade issues or because of an important therapy or something related to that, as a priority substance. That is how the roster of compounds to be reviewed is established by the expert committees.
When compounds have been in use for a long time and there is concern that the data originally used to review the compound is now out of date, and when compelling new evidence has become available after the last review, they may be put back on the roster for a re-evaluation.
The expert committee may, in part, also set its own priority. If, on a scientific basis, it becomes aware of important issues that should have the attention of the committee, then the committee may influence its own priorities. The last case occurs only infrequently. Normally, the referrals for priority substances come either from a national government or from the appropriate Codex committee.
The example that you chose, rBST, is a very good example of the new information to which I was referring. rBST was first reviewed by the World Health Organization Expert Committee in 1993. At that time, the World Health Organization Expert Committee concluded that the use of rBST does not constitute a risk to human health.
As a point of clarification, the committee does not include consideration of any issues other than human health. If an issue relates, for example, to animal health -- and you have heard some testimony about that -- the committee offers no judgment as to the validity of that claim or concern. The committee is restricted to considerations of human health.
The WHO Expert Committee reviewed rBST in 1993 and concluded at that time that it did not constitute a risk to human health with regard to its intended use.
There has been intense interest in this compound in the intervening years and there were certainly some people who felt that there was additional information that should have the attention of the committee. Therefore, the rBST issue was referred back to the committee in 1998 and the committee reviewed rBST for a second time.
Because rBST was on the docket in 1998, you can imagine that the secretariat of the World Health Organization empanelled a group of men and women on the expert panel who would have particularly outstanding expertise in issues that might be referable to human health related to the use of rBST. For example, the 1988 panel included a clinical endocrinologist from the Children's Hospital of Cincinnati who has had a distinguished career looking at issues specifically related to things such as insulin-like growth hormone. We recognized that that would become an issue and that it would be important to have someone on the panel who had recognized expertise related to insulin-like growth hormone and paediatric health. Two pathologists were also present on that panel. The composition of the panel will change from time to time to reflect the particular issue that the panel expects to be reviewing at a given session.
The 1998 consultation reaffirmed the decision of the 1993 panel in that they concluded, after a review of the new evidence that had become available between 1993 and their deliberation in 1998, that there had been no additional information that had become available that would suggest that their 1993 decision was flawed. They essentially reaffirmed that decision.
Senator Robichaud: But the consideration is made on the studies and the reports that are before you.
Mr. Ritter: That is right.
Senator Robichaud: We had the Canadian panel here who looked at the information. The two members here were saying, "If I had my personal way, I would not approve it now. However, there is nothing in the information that I received to say that it can or could be dangerous to human health. Therefore, at this moment, I see no reason why it should not be approved."
Is that also the case with the 1998 committee?
Mr. Ritter: No, I do not think so. The nature of scientific investigation is that it is impossible to verify a negative hypothesis; we can only establish the presence of a positive one. Over the years, as a scientific community, we have developed a protocol or a paradigm where we look at the outcomes of a number of different studies to tell us about the likely effect of a substance on human health. Depending on the nature of the substance, that list of studies may change from one situation to another. As a compound, rBST has certainly been subjected on an international scale to the sorts of studies we are conducting.
What the panel essentially said in 1993 and in 1998 is that, based on the evidence available to us, which we believe is sufficient to draw a scientifically defensible and rigorous decision, we do not believe that the use of rBST constitutes a risk to human health.
As I said to Senator Spivak a moment ago, I will not offer you any absolute assurance that we would not change our mind 25 years down the down the road. However, I will tell you that the criteria that a compound needs to meet are very rigorous. Based on those criteria, the panel, including participation from a widely recognized paediatric endocrinologist, has now twice concluded that the evidence available is both sufficient and rigorous and no concern is raised with regard to human health from the use of this recombinant bovine somatotropin in accordance with its intended use.
Senator Robichaud: Would you say that it would be unlikely that this would go to that particular committee for a third time?
Mr. Ritter: No. As I mentioned to you, the committee priorities are primarily established by national governments. If there continues to be a significant amount of interest and work on this compound, it is entirely possible that it would be referred to the committee a third, fourth or fifth time. It depends on how much priority national governments put on the continuing evaluation of the compound. It is difficult to predict when or if that might occur.
Senator Robichaud: No, I am not asking you to do that.
Mr. Ritter: I would not say that it is unlikely. Quite frankly, given the intense interest in the compound, if anything, I would say that it is probably likely, rather than unlikely.
Senator Kinsella: How are the decisions that are taken by the committee arrived at? Are they done by majority vote or consensus? Are minority opinions expressed? Can there be a minority report? If 32 to 39 scientists are operating as individuals, how are their decisions formed?
Mr. Ritter: To be quite candid, I think there is actually a mechanism for a formal vote. I have never participated on an expert committee where that mechanism has been invoked.
I am sure you will appreciate that given that there are two to three dozen scientists, all with significant experience in a particular issue, there may be some very strong opinions around the table. The purpose of the chair at any particular committee is to try to recognize that there may be legitimate differences in opinion based on the same data.
The intent is not to dismiss an opinion because it is in the minority view. On the contrary, the intent is to recognize every opinion and to try to build a report that reflects on the totality of the opinions that have been expressed. I think the reports do that very well. If you read the language in any of the reports that the committee has issued, you will see that the words are carefully selected so that all of the possible views are expressed.
The committee has two tiers. The committee includes what we call members, who are the voting representatives. That membership list will change from time to time. There is a second tier of people who are called the WHO temporary advisors. They are people who are appointed to individual meetings to review a compound to present it to the panel, and so on.
If it came to a vote, it would actually be the members who would vote, not the WHO temporary advisors. As a matter of record, I have never been on the member side. I have always served as a temporary advisor.
Senator Spivak: Dr. Ritter, I am sure you have read the criticism of the JECFA opinion. No one who is critical of that opinion has said, "This is a dangerous drug." What they have said is, "There are enough signs here...." Those signs include the passing through of IGF-1, the pasteurization of milk, the target population and so on. Scientists have not said that the drug is dangerous, they have said that it needs more study. None of the studies that they have said need to be done have been done.
Canada is a signatory to the biodiversity convention which says that we ought to use the precautionary principle. The precautionary principle says that if there is a dispute as to the manner of harm, do not proceed. This is a non-therapeutic drug that has only been introduced for commercial reasons.
You are a scientist. What value do you put in that sort of criticism? It fine to say, "There was a noted this and a noted that," but these concerns are being raised. You cannot ignore them.
How can anyone say they trust the JECFA because of one noted paediatrician when JECFA has ignored these things? You are right that at the moment there is no proof that this is a dangerous drug, but that is not the issue.
Mr. Ritter: Senator, with respect and to be fair, we must recognize that there are some scientists who have suggested that there are some very important unanswered questions.
Senator Spivak: Right.
Mr. Ritter: There are many others who have said that there are no important unanswered questions.
Senator Spivak: There have been a thousand studies done each year on this. Have you looked at all of them?
Mr. Ritter: I have not looked at all of them, no.
Senator Spivak: Is that anecdotal evidence, then?
Mr. Ritter: There could be a thousand studies done every year. The nature of scientific investigation is such that it almost always produces results that can be conflicting. That is why I say that we must be prepared to recognize that it is entirely possible and plausible to come to different conclusions based on the same data. That is the nature of scientific investigation.
Senator Spivak: Right. Have you read the European investigation?
Mr. Ritter: I have read European commission reports on BST.
Senator Spivak: Did you read what they said about risk assessment?
Mr. Ritter: Yes.
Senator Spivak: This is not a nominal group. This is an important group.
The Deputy Chairman: Mr. Ritter, have you read the proceedings of our committee?
Mr. Ritter: I have not.
The Deputy Chairman: Have you read our report?
Mr. Ritter: I have not.
The Deputy Chairman: It is a very good report. We have heard so much testimony here. We uncovered much more than we expected. When one spades the garden and uncovers worms, one goes fishing. We may look like we are on a fishing expedition here but we have uncovered many things that the public is not aware of.
We spoke about the appointees. I said earlier that I could go as an observer to the Codex Alimentarius, but I cannot go as a voting delegate because I am not a scientist. I find that difficult to accept because I have been associated with the scientific world throughout my career in agriculture. The insinuation is that no one but a scientist can vote on whether a food is safe. They, too, get their information from documentation. I find that insulting.
I was told that the Department of Health sends out invitations to people they think are qualified, asking them to attend.
Mr. Ritter: They may do that but I have never received such a invitation.
The Deputy Chairman: I have not received one either. We are in the same boat.
Mr. Ritter: If you are offended by the fact that you seem to be excluded from the process, I share in your indignation. Since 1993, I have never been invited, if such an invitation exists. Moreover, I referred to the "gaps report" earlier. If you have not had the distinction of being referred to as a bozo, then I am one up on you.
I certainly find that kind of commentary to be entirely inappropriate. I consider it to be reprehensible. Although I have not taken legal action, I think it is very unfortunate that otherwise well-intentioned scientists would reduce the level of conversation to the point that it becomes a personal attack. It undermines the credibility of what they are setting out to do. It becomes a personal vendetta and that is unfortunate. That comment was made by someone I have never met.
The Deputy Chairman: Dr. Ritter, is there not something in the health act that states that if there is any doubt about a substance, it should not be approved?
Mr. Ritter: Are you referring to the Food and Drugs Act in Canada?
The Deputy Chairman: Yes.
Mr. Ritter: In fact, BST is not approved in Canada. There is continuing concern on the part of the regulating authorities in Canada that have responsibility for BST and, clearly, that is expressed in their opposition to the drug. BST is not, to the best of my knowledge, approved for use in Canada.
If there is such a clause in the act, the spirit of that clause is being upheld based on the testimony that you have heard from staff of the Bureau of Veterinary Drugs.
The Deputy Chairman: We have letters addressed to Monsanto saying that, in one year, BST will be approved. That is rather shocking, especially when we hear witnesses such as Dr. von Meyer. His whole life has been associated with research. He stated that there was no chronic health testing at all on humans. Monsanto quotes 90-day health testing on 30 rats over a nine-year period. That is supposed to be safe for humans consuming this product?
Mr. Ritter: You have raised an important point. In the realm of toxicology, we have been developing formal, structured protocols for about 30 or 40 years. Cancer studies or long-term studies are certainly one group of studies frequently required for substances, be they veterinary drug residues or pesticides or environmental contaminants or a whole range of others.
As I said earlier, the roster of studies is not always the same. They must be adapted to accommodate the particular substance under consideration. It is incorrect to view the absence of a so-called chronic cancer study on rBST as a deficiency that must be addressed before that particular point of safety can be resolved. That is not only my opinion but it has been the opinion of many learned bodies that have referred the safety of BST. It is not so much that the studies are missing. The relevant question is whether they would be useful.
Given that this is a protein and given our understanding of how proteins are broken down, the decision has been taken by many learned organizations around the world that those sorts of studies, in this particular context, would not significantly contribute to our understanding of the safety of this drug. It is not an omission, senator.
The Deputy Chairman: Dr. von Meyer expressed strong concerns about diabetes and the insulin factor. He had done a lot of work on that.
Mr. Ritter: The World Health Organization issued a document, number 41 in the food additive series, that, among other things, details the conclusions of the 1998 expert consultation that reviewed rBST.
Mr. Chairman, you have specifically referred to the issue of risk with regard to diabetes mellitus. I would be remiss if I allowed you to conclude this afternoon with the impression that somehow or another this is a deficiency that the panel has not considered but that someone has brought to your attention here. That is simply incorrect.
The panel's work included testimony from a noted clinical endocrinologist who makes his living looking at exactly these sorts of issues, particularly in children. The panel report states that exposure of human newborns to cow's milk will increase the risk for developing insulin-dependent diabetes mellitus by about one and a half times.
The committee considered whether exposure of newborns to milk from rBST-treated cows further increases the risk, that is, if I can paraphrase, whether exposure to milk per se increases the risk, never mind if it is milk that contains rBST or not. It concluded that because of its unchanged composition, the milk of rBST-treated cows would not pose an additional risk to the development of insulin-dependent diabetes mellitus. I sincerely hope that I am not taking any of this out of context. It states that with the absence of significant changes in the composition of milk from rBST-treated cows that could contribute to an additional risk with regard to the development of insulin-dependent diabetes mellitus, the committee concluded that rBST can be used without any appreciable risk to the health of consumers.
Again, to bring it to closure, it would be remiss of me to leave you with the impression that this issue has not been investigated intensively by the committee. It has. The conclusion that they reached is simply different from the one that you may have heard expressed otherwise. I respect the diversity of opinion you will hear on this issue.
The Deputy Chairman: I am going by memory because I do not have his presentation in front of me. You say 1.5 times. I thought, and committee members can correct me if I am misinterpreting Dr. von Meyer, that he said about 33 times. He had all this evidence that supported that.
You are quoting from the WHO and FAO. I do not know that much about WHO, but I know quite a bit about FAO. I have no real confidence in many of those people. I was associated with them for a long time.
Mr. Ritter: If you are impugning the credentials of the individuals on the committee, will you allow me quickly to give you a flavour of the sort of people that serve on it? Lars Eric Aplgrin from the Swedish University of Agricultural Sciences; Professor Alan R. Boobis from the Imperial College School of Medicine, University of London; Dr. Gary Borman, pathologist with the United States National Institutes of Environmental Health Scientists; Professor Jock McLean, Vice-chancellor, Swinburne University in Australia.
The Deputy Chairman: He appeared before our committee.
Mr. Ritter: Yes, he did. Another member is Professor John Palermo-Neto from the Faculty of Veterinary Medicine School of Pathology, University of Sao Paolo. I could go on.
There are two important points about the list. First, you will not see an industry representative at this committee, now or ever. Second, I do not know the individuals to whom you are referring, but these people are drawn from the international community.
The Deputy Chairman: I said I did not know about WHO, but I did know about FAO because of my long association with it.
Mr. Ritter: Yes, but I do know about WHO.
The Deputy Chairman: I want to go back to Dr. McLean for a minute. I could not believe that he could come here and talk in favour of rBST when his own country had banned it. Who was he representing -- himself?
Mr. Ritter: Only himself.
The Deputy Chairman: They paid his way to come here and tell us that. Did the Australian government not have some advice that prompted them to take the action that they did? They must have said, "rBST shall not be used in our country." Dr. McLean comes here. He cannot convince them to use it in Australia, but Health Canada paid his way here to tell us how good it was, and perhaps how dumb we are.
Mr. Ritter: I do not think anyone is making any such allegation. I think Professor McLean was trying to tell you that, with regard to human health, he does not have a concern. I think the Australian government might have based its decision on concerns that go well beyond what Professor McLean may have said to you.
Again, let me say that the nature of scientific investigation is such that it is entirely possible to arrive at different conclusions based on the same set of information. It is also possible to do it based on different information.
The Deputy Chairman: Can you tell me if the doctors at WHO had any more scientific information than the information that was presented to us?
Mr. Ritter: I do not know what testimony was given to you.
The Deputy Chairman: Is it possible for us to get the information that they used to make that decision?
Senator Spivak: No, it is not.
Mr. Ritter: No.
The Deputy Chairman: That is too bad. I thought we were in a democratic country.
Senator Spivak: To interject, of course the conclusions that you read from the JECFA are directly contrary to what the European Union report suggested. Again, that goes to the heart of the question. They carefully listed the risk assessment criteria, rather than risk management. That goes to the heart of the question of precautionary principle and that if there is dispute as to the harm of a product you do not proceed. That is a valid scientific principle, is it not?
Mr. Ritter: Which one?
Senator Spivak: The precautionary principle.
Mr. Ritter: The precautionary principle is not a scientific principle at all; it is a risk management principle.
Senator Spivak: No, it is not.
Mr. Ritter: We could debate that.
Senator Spivak: It is not a risk management principle.
Mr. Ritter: I think it is.
Senator Spivak: All right.
Mr. Ritter: We need to ask ourselves: At what point in time is there significant scientific evidence to conclude that something is either acceptable or not acceptable?
Senator Spivak: That is a different question.
Mr. Ritter: That is the question that this committee dealt with in 1998. On the depth and breadth of the evidence that it examined, it said that it was happy with the rigor of the information and satisfied with its breadth and scope. On the basis of that information, it concluded two things. First, that it can make a scientifically defensible conclusion; and, second, that the use of this particular drug does not constitute a risk to human health.
I am not telling you that studies to contradict that conclusion were not available. What I am telling you is that, based on all the evidence, this was their conclusion.
Senator Spivak: Is that the same thing as saying this drug is safe for human use?
Mr. Ritter: It is not used in humans.
Senator Spivak: No, but this drug used in animals, which has an impact on humans. In addition, humans then consume products that come from those animals. Is that the same thing as saying it is safe?
Mr. Ritter: No.
Senator Spivak: All right.
Mr. Ritter: We do not use the word "safety." "Safety" is a word that politicians like to use. Scientists do not use it.
Senator Spivak: Safety is the thing that people want to know before they put something in their mouths.
Mr. Ritter: Senator, I could ask if you could be absolutely certain that you are safe crossing the street to Parliament Hill. If you were to say "yes," you would be mistaken. That is the context in which scientists can never offer an assurance of safety.
Senator Spivak: I have to walk across the street, but we do not have to have rBST.
Mr. Ritter: As a matter of fact, you do not.
Senator Spivak: That is right.
The Deputy Chairman: I wish to go to the WTO. Earlier, I stated that the new president of the WTO comes from New Zealand, which represents 74 million sheep and 3 million people. It is not as big as Toronto, but the new president will be telling the world -- and us -- what we should do. Again, New Zealand has banned rBST. Do you have any opinion on what his stand should be?
Mr. Ritter: I must tell you, first, I have not made any attempt to keep current on the regulatory status of BST since I left government in 1993. To tell you that my interest in the issue in general, particularly its regulatory status, is about as low as it can get would be an understatement.
I did not directly participate in the review of the WHO panel. In fact, the review was led by a scientist from a German university and by a scientist from the United States Food and Drug Administration. These two individuals were responsible for leading the WHO review of BST in 1998.
I have no idea on what basis New Zealand came to the conclusion that it would either allow or disallow BST. For me to speculate as to the basis for their decision would be just that -- sheer speculation.
The Deputy Chairman: I think Dr. McLean insinuated that it was politics. They knew that they would be able to sell their dairy products much more easily on the world market if they had the publicity that comes with a guarantee that they were not using rBST. New Zealand is a big exporter of dairy products.
When you go back to globalization, I held elected office for nearly 39 years from the time I was 21 until John Turner fired me. I was then fired by Joe Clark three months later, to the day. I am a distinguished Canadian, having been fired by a Liberal and a Conservative within a three month, although I did not think I did anything wrong.
Having spent that much time in a democratic way of life, I am concerned, because I hear that globalization and the WTO will rule against what a sovereign nation decides to do. I am dumbfounded that we have come this far without more concern.
I will not go so far as to say "civil insurrection," but I am concerned that things we have built are being taken away from us, such as supply and management in our dairy industry. Any successful industry in the world is managed through its supply. They do not just produce something and hope to God that someone will buy it -- especially in agriculture, where we are producing perishable products. We built an industry that we could sell because of the quality of our products and the fact that they were safe.
I told a story here earlier about a group of 21 people from China who once visited our house in Essex County. My wife invited them to come to our house and she asked the Foreign Affairs people what to feed them. They gave us a list of Chinese food and she said, "I do not have any of that." Therefore, she prepared a table of Canadian foods, such as cheese and cold cuts, chicken, and the different food that we had at home. The only thing that they did not eat was the tablecloth. A couple of the Chinese delegates talked to my wife afterwards and she mentioned how surprised she was that they ate everything, because it was mostly new food to them. Their response was that they were not afraid to eat anything in Canada because they knew it was safe.
That was before globalization. That was before NAFTA. We have more food coming into Canada now that is not inspected. I am sure that we have both visited many countries whose products do not meet our standards, yet we are getting product from them now. I am concerned about this new world trade order, which they make out as something new. Globalization? We had slave trade and we had pirates. Sir Walter Raleigh was a great pirate. This is not new, yet we give this impression. We have 132 countries, yet you say 131 voted against you.
Mr. Ritter: Mr. Chairman, I do not know if the committee has concluded with their formal questions. However, Senator Spivak alluded a few moments ago to the fact that I am a relatively important Canadian.I believe that is what she said.
Senator Spivak: Yes.
Mr. Ritter: My mother would certainly agree with you.
In conclusion, I wish to say that for those of us who have the opportunity to travel, and in particular in the time that I was in the public service, I can only echo what you are saying. You need only leave home to recognize just how good we have it here. It is not an accident that Canada has been voted repeatedly by the United Nations as the best place in the world to live. We have far and away one of the most abundant, nutritious and safe food supplies on the face of the earth, and we buy it at a cost that challenges just about anyone anywhere.
In large measure, that is due to the regulatory framework that has existed within Canada. I know that, because I used to run part of that framework. I would be leading you astray if I left you with the impression that that regulatory machinery has ever done anything other than serve the interests of Canadians. I fervently believe that in my heart. At the same time, however, we must recognize that there can and will be differences of opinion among scientists. That does not make one wrong and one right. The nature of the discipline is that we must be prepared to accommodate differences.
As I was trying to point out to Senator Spivak, as scientists we are compelled to look at the totality of evidence and draw conclusions on the basis of what is available. We must not make a premature conclusion, or draw a conclusion on the basis of inadequate information. We must base our conclusion on the information that is available to us, provided that it is sufficient and is rigorous enough to allow a scientifically defensible conclusion to be taken.
The WHO Expert Panel has arrived at that position. That does not mean that they do not recognize that other opinions have been offered, but it is not their opinion. Certainly, in my association with the panel, and in my association with the people who are on the panel, I have a deep and abiding respect for those who serve there. I have never been given any reason to believe that they function at any level except in the interest of advancing human safety with regard to food trade.
The Deputy Chairman: I hope I did not cast any aspersions to the effect that these people were not knowledgeable.
We heard Dr. MacLeod tell us the other day that he never read all the documents. He based his evidence on what he had time to consume. I sit here as a chairman and member of this committee. Perhaps Dr. MacLeod missed something in there. Dr. von Meyer said he missed something in there. He is another top scientist and researcher.
Canada, as you said, is the envy of the world. Its citizens came from all over the world, and we built the country up to something that is the envy of the world. The King of France was once asked about our country, and he said that we should be left to survive the best way we know how. After all, who would want that land of ice and snow anyway? We built it by working together.
I am afraid of globalization and of the World Trade Organization; people who will make Parliament insignificant. There will hardly be a need for Parliament in a few years -- provincial or federal -- if NAFTA and the World Trade Organization will be making the deals.
Senator Spivak: I wish to make one comment. Dr. Ritter, I appreciate your comments about Canada and about the quality of scientists. There are, however, changing circumstances, in that a few large corporations are controlling the food that everyone in the world will eat. There are many commercial drugs -- non-therapeutic drugs -- that may be cast around the world. Many of those drugs do not have a therapeutic value, only a commercial value. In those circumstances, you must admit that we should proceed with caution.
It is risk assessment, not risk management. Under risk management, I believe I would absolutely agree to it when you have a drug that might prevent something like cancer and that would be beneficial to mankind. However, here you have this whole other class of drugs, and that is quite a different proposition.
Mr. Ritter: Let me suggest something to you, senator, as a scientist.
Senator Spivak: We have had thalidomide, the blood scandal, the breast implants. Look at the history. It is not at all as though we are simply Luddites asking to be saved from this technology.
Mr. Ritter: We should be cautious with regard to introducing substances into commerce, whether they are therapeutic drugs or non-therapeutic drugs, and regardless of whether or not they have this commercial interest. I believe we should be careful, period. I would not attach any specific limitation on that concern. It is an appropriate concern for all substances at all times, not just in this particular case.
I am not a dairy farmer. I must tell you, however, that I feel that you are being unfair to some of the dairy producers when you say that this has no value. The fact is that these people have made compelling arguments, both nationally and internationally, that the use of this drug may in fact significantly lower their input costs. They have made arguments that it may be possible for them to continue to make a living so that that kind of lifestyle, that way of Canadian life, can actually be sustained. I find it a little difficult to summarily dismiss those representations. I am not in a position to evaluate them.
Senator Spivak: Those sentiments were only expressed by people that Monsanto brought here. We did not get that representation from the farm organizations in Canada.
Mr. Ritter: So be it. Worldwide, I have heard those representations from countries other than Canada.
If it were true that there is no benefit to dairy farmers, I think that would be tantamount to accusing the dairy farmers who do use it of being unbelievably stupid. I have far more respect for them than that. I believe they are convinced that this particular technology has value for them or else they would not do it. Never mind Monsanto. This is a very clever group of men and women who are the leading independent business people in this country. If they did not believe it had value for them, why would they use it?
Senator Spivak: Dr. Ritter, that is not what we heard in this committee. What you are suggesting may be true in other places, but not here.
Mr. Ritter: Again, I say to you that there can be a divergence of opinion. I accept that you have heard one opinion, and I am suggesting that there may be other opinions on the same issue. Surely we cannot argue that the drug is in use -- not in this country, perhaps.
Senator Spivak: Oh, yes.
Mr. Ritter: Surely we cannot argue that the people who use it believe it has value. They are either very stupid --
Senator Spivak: No, not at all.
Mr. Ritter: Then why would they be using something that has no value?
Senator Spivak: This is a different argument, and it is not scientific.
Mr. Ritter: It is scientific, but it is human health. The economics of the use of this substance are no less scientific than human health, but it is not a human health issue. I agree with you there.
Senator Spivak: It is an economic issue.
Mr. Ritter: But that is science.
Senator Spivak: In the opinion of some, it is a very dismal science.
The Deputy Chairman: At one time, Dr. Ritter, we had 1,200 dairy cattle tested in Canada for everything. That testing was abandoned some years ago. Imagine if we had to do our own testing on rBST. After analyzing the milk from those cows, we knew exactly what was done to them. We were world leaders in ensuring that the product was safe. Earlier today, someone said that people up to 50 years of age consume a lot of milk. It is a food responsibility.
We have been given enough evidence here to give us some doubt. We had farmers say to us that this product is good. We had other farmers say to us that they would not dare use it.
I travel all over Canada, and I find great controversy amongst our rural people. Some evidence suggests that this product is economically viable. Other evidence suggests that farmers must become good managers to become that productive.
I am concerned with what Senator Spivak said. By the year 2003, it is estimated that five companies will be telling the people of the world what they will eat. They will be in charge of 80 per cent of the food production in the world. I fear that, because, as you said earlier, that is not how we built this country.
I wish to thank you very much for appearing here this afternoon, Dr. Ritter. I hope you do not think we have been too tough on you.
Honourable senators, given that we asked Dr. Ritter to appear before us today, I need a motion stating that he be discharged.
Senator Spivak: I so move.
The Deputy Chairman: Is it your pleasure, honourable senators, to adopt the motion?
Hon. Senators: Agreed.
The Deputy Chairman: Carried.
You are free to go, Dr. Ritter. Thank you for being here today.
The committee adjourned.