U. S. Department of health and human services public health service food and drug administration



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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
* * * * *
PUBLIC HEALTH SERVICE
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FOOD AND DRUG ADMINISTRATION
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TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE
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MEETING
WEDNESDAY,

APRIL 15, 1998
* * * * *

The meeting took place in Versailles Rooms I & II, Holiday Inn, 8120 Wisconsin Avenue, Bethesda, Maryland 20814 at 8:00 a.m., Paul W. Brown, MD, Chair, presiding.



PRESENT:
Paul W. Brown, MD, Chair

William Freas, PhD, Executive Secretary

Donald S. Burke, MD, Member

Linda A. Detwiler, DVM, Member

Leon Faitek, Member

Barbara W. Harrell, MPA, Member

David G. Hoel, PhD, Member

William D. Hueston, DVM, PhD, Member

Raymond P. Roos, MD, Member

Lawrence B. Schonberger, MD, Member

Eric Decker, PhD, Temporary Voting Member

Peter G. Lurie, MD, Temporary Voting Member

Doris Olander, DVM, Temporary Voting Member

Elizabeth Williams, PhD, Temporary Voting Member

Don Franco, DVM, Industry Liaison
SPEAKERS PRESENT:
Fred Bader, PhD

John Bailey, PhD

Raymond Bradley FRCVS, FRC Path

Stanley Gorak

Charles Green, PhD

Sharon Smith Holston

Mitch Kilanowski

Mike Langenhorst

Philip Merrell, PhD

Gerald Pflug, PhD

David Taylor, PhD

Dennis Walker


ALSO PRESENT:
David Asher, MD

Bob Brewer, DVM

Yuan-Yuan Chiu, PhD

Kiki Hellman, MD

John Honstead, DVM

Thierry Salmona


A G E N D A
PAGE

MORNING SESSION
Opening and Administrative Remarks

William Freas 5


Introductory Remarks Sharon Smith Holston 13
TALLOW AND TALLOW DERIVATIVES
Background John Bailey 18
TALLOW PRESENTATIONS
Opening Remarks Don Franco 41
Feedstocks and Process Controls

(slaughterhouse/renders)

Mike Langenhorst 43
Manufacturing Process (renderers)

Mike Langenhorst 69


Question/Answer Period 74
Market Dynamics Data Mitch Kilanowski 87
Inactivation of BSE Agent by Rendering

David Taylor 98


Safety Data - BSE Update - Status of the Outbreak - New Tissues Distribution

Raymond Bradley 113


Question/Answer Period 133
Lunch Break
A G E N D A
PAGE
AFTERNOON SESSION
TALLOW DERIVATIVES PRESENTATIONS
Introduction to Soap and Detergent Association (SDA)

Gerald Pflug 155


Feedstocks - Considerations for Selections

Types and Specifications

Overview of US Oleochemical Industry

Charles Green 159


Question/Answer Period 184
Manufacturing Process for Mg Stearate

Philip Merrell 188


Manufacturing Processes for Polysorbates

Stan Gorak 192


Oleochemical Safety in the United States

Dennis Walker 198


Safety of Pharmaceuticals Fred Bader 208
Committee Questions 227
Meeting Adjourned



P-R-O-C-E-E-D-I-N-G-S

8:07 a.m.

DR. FREAS: Mr. Chairman, invited Committee members, invited guests, members of the public, I would like to welcome you to today's meeting of the Transmissible Spongiform Encephalopathies Advisory Committee. I am Bill Freas. I'm the Acting Executive Secretary for today's session.

I asked the members of the audience if they have questions for anybody sitting at the table, please do not directly approach the members at the table. Please see me and I will relay your questions to the Committee members. So, we're asking you not to directly communicate with the table.

Today's presentations will be open to the public. The public is more than welcome to spend the entire day today.

At this time, I would like to go around the head table and introduce the members seated at the head table. I'll be starting on the right-hand side of the room. That's the audience's right-hand side of the room. At the first seat is our industry liaison representative for today, Dr. Don Franco from the National Renderers Association.

If members would raise their hand just so the people in the audience can see who you are, I'd appreciate it.

Sitting next to Dr. Franco is Dr. Lawrence Schonberger, Assistant Director for Public Health, Division of Viral and Rickettsial Diseases, Center for Disease Control. In the next seat is Mr. Leon Faitek, consumer advocate on this Committee from San Diego, California. In the next seat is Dr. Raymond Roos, Chairman of the Department of Neurology, University of Chicago.

Next is Dr. William Hueston, Associate Dean, Virginia-Maryland Regional College of Veterinary Medicine. The empty seat right here in front of the podium will soon be filled by David Hoel, Professor and Chairman, Department of Biometry & Epidemiology, Medical University of South Carolina. Next, in front of me, is Dr. Linda Detwiler, Senior Staff Veterinarian, U.S. Department of Agriculture. Next is our Chairman, Dr. Paul Brown, Medican Director Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke. The next seat is mine.

Next to me is one of our new Committee members. I would like to welcome Dr. Donald Burke, Director, Center for Immunization Research, Johns Hopkins University to the Committee table. Next is Ms. Barbara Harrell, our consumer representative, Director, Division of Minority Health, State of Alabama Department of Public Health.

Next we have four temporary members for this session. They are Dr. Peter Grant Lurie, Visiting Assistant Research Scientist from the University of Michigan; Dr. Doris Olander, Research Associate, University of Wisconsin; Dr. Eric Decker, Associate Professor, University of Massachusetts; and Dr. Elizabeth Williams, Professor, Department of Veterinary Service, University of Wyoming. Welcome to everybody.

I would now like to read into the public record the conflict of interest statement required for this meeting.

"The following announcement is made part of the public record to preclude even the appearance of a conflict of interest at this meeting.

Pursuant to the authority granted under the Committee charter, the Director for the Center of Biologics Evaluation and Research has appointed Drs. Peter Lurie, Doris Olander, and Elizabeth Williams as temporary voting members. In addition, the Director for the Center for Food Safety and Applied Nutrition has appointed Dr. Eric Decker as a temporary voting member, and Mr. Don Franco from the National Renderers Association as the industry liaison representative for today's meeting.

Based on the agenda made available, it has been determined that the agenda topics address matters of general applicability. Therefore, the general waivers previously approved by the Agency for all members of the TSE Advisory Committee including Drs. Donald Burke, Eric Decker, Elizabeth Williams are applicable for this meeting. Drs. Peter Lurie and Doris Olander have no financial interests to disclose.

Furthermore, it has been determined that all financial interests in firms regulated by the Food and Drug Administration which have been reported by participating members and speakers as of this date present no potential for an appearance of a conflict of interest at this meeting. The general nature of the matters to be discussed by the Committee will not have a unique and distinct effect on any member's personal or imputed financial interests.

In regards to FDA invited speakers, the Agency has determined that the services of these participants are essential. There are reported interests which are being made public to allow participants to objectively evaluate any presentation and/or all comments made by speakers. These interests are as follows:

Dr. Raymond Bradley is a paid consultant to several firms both in the U.S. and abroad that may be affected by today's meeting. Dr. David Taylor is a paid consultant for Proctor & Gamble and Company on topics related to the Committee's activities. Dr. Robert Brewer had no financial interests to disclose.

In addition, the following participants were not screened for conflict of interest since they are here representing industry. They are Mr. Doug Anderson and Mr. Mitch Kilanowski from Darling International, Incorporated, Dr. Fred Bader from PhRMA, Mr. Stan Gorak from ICI Americas, Dr. Charles Green from Witco Corporation, Mr. Mike Langenhorst, ANAMAX Corporation, Dr. Phil Merrell, Mallinckrodt Chemical Company, Dr. Gerald Pflug, Soap & Detergent Association, Dr. Thierry Salmona and Mr. Reinhard Schreiber from the Gelatin Manufacturers of Europe, and Mr. William Springer, the Coalition of Gelatin Capsule Manufacturers, and Mr. Dennis Walker of the Proctor & Gamble Company.

In the event that discussions involve specific products or specific firms for which FDA participants have a financial interest, participants are aware of the need to exclude themselves from such involvement and their exclusion will be noted for the public record. A copy of the waivers are available upon written request to the Freedom of Information Office.

With respect to all other meeting participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firms upon whose products they may wish to comment upon.

So ends the reading of the conflict of interest.

Dr. Brown, I turn the microphone over to you.

CHAIRMAN BROWN: Thank you, Bill Freas.

Welcome, everyone. I think the FDA has stuffed into these two days, probably as full a plate as I can recall but we'll try and retain our habitual light touch. The Committee which, happy to say, is a quick study is completely up-to-date on the background materials and can tell you the difference between palmitic, lauric and linolenic acids and the number of carbon items in each. Therefore, I wonder if the speakers can exercise a certain amount of flexibility. You will be given your full allotted time, not a minute more. But it looks to me from the program as though there is the opportunity for an enormous amount of redundancy in subsequent speakers. Therefore, if you spot that kind of material having already been presented and which would be presented in your own presentation, I would beg you to skim over it rather quickly. We have an enormously full day, probably will not terminate until close to 6:00. Tomorrow looks like the same kind of day. Because of a certain amount of disgruntled response to the Committee's decisions about gelatin and dura meter, we're looking again, at least briefly at the end of tomorrow, at those two substances as well.

With that, we will begin our lengthy consideration of tallow. The first speaker is Sharon Smith Holston who is, and has been for many years, the Deputy Commissioner for External Affairs for the FDA.

Sharon?

Yes, Leon?



MR. FAITEK: Dr. Brown, the issues here, that we will be talking about here are very similar to the gelatin. I'd like to go back to item 12 that was included in the packet. Perhaps it was my misunderstanding, but is the recommendations that are listed on page 2 of that item as described -- recommendations by the FDA, are those in keeping with the recommendations that this Committee made regarding the exclusion of gelatin products from BSE countries? If so, if they're not -- in the recommendations, is there any scientific evidence for that being?

CHAIRMAN BROWN: I think, Leon, we can defer that until the discussion of gelatin. Gelatin is really not going to come up until tomorrow afternoon. We're on tallow.

MR. FAITEK: I understand. But some of the issues are very similar between these two items.

CHAIRMAN BROWN: And do I understand you correctly to say "well, if the FDA is going to not introduce recommendations that are in total accord with the Committee, then maybe" -- well, I don't know exactly where you're going with your thought.

MR. FAITEK: Well, somewhere along that line.

CHAIRMAN BROWN: Yes. We can only do what we're asked to do, Leon, which is provide advice. The FDA makes the policy. My reading of what the FDA did was that in broad terms and in many of the specifics, they followed our recommendations and our advice to them. I would expect no less from them with respect to tallow.

MS. HOLSTON: Well, can I at first at least correct the record and let you know that I am not here to start the discussion about tallow. I am here really just to welcome you and to thank you, frankly, on behalf of FDA, our lead Deputy Commissioner Michael Friedman and myself for being here and for the work that you're about to do to help advise the Agency on TSEs.

You've dealt with this subject obviously in the past. Many of you had helped us to develop some very important guidance documents on gelatin, on dura mater and safe sourcing and use of human plasma derivatives. Today's meeting from our perspective is just another very important step as we try to look at the safety of the products that we are supposed to be regulating. We very much appreciate the help that you have committed to give us in, as Dr. Brown has said, a very, very full two days on some matters that are exceptionally challenging from a scientific perspective.

My own personal in-depth -- not in-depth, but certainly my own personal involvement with this issue goes back to last October when I lead a delegation of FDA staff to Europe to meet with European officials about the ban that they had proposed on specified risk materials that was passed last July. We wanted to meet with our colleagues in the European Union to emphasize to them, or at least to impress upon them, the impact of their SRM ban on the availability of critical pharmaceutical and other medical products in the United States, and the effect that that would have on the availability of these products as far as the American consumers were concerned.

In preparing for this mission, obviously, I was greatly impressed if not even a little bit depressed by the exceptional complexity of the issues that we were preparing to talk to the Europeans about. The fact that the scientific complexity was enormously compounded by the political aspects, the social aspects of the issue, and yet, we were going over there to talk to them about a decision that they had passed. One of the things that surprised us when we got there and began to talk with our colleagues was how little awareness there actually was of the impact on the decision on the availability of certain medical products, not only for the American consumer but for the European population as well.

In our very first meeting with a high ranking senior official in DG3, he assumed, obviously, that we were there to promote US trade and that we were there on the behalf of the American pharmaceutical industry. It was necessary for us to take the time to explain to him that no, we were not a trade delegation. That we were, in fact, there in the interest of public health and to explain in some detail what the impact of this decision would be on their consumers as well as on ours. Needless to say, recently when they decided that the issue was so enormously complex that it was in everyone's best interest to put it off still further. It has now been postponed until next January while they continue to evaluate these issues. That was gratifying to us and many of us hope that in some ways, our trip and the explanations that we made had at least some impact on causing them to take a pause and to give this issue some second thought.

In the meantime, of course, we continue to look at the issue. Coming up in June, the Joint Institute for food safety and applied nutrition which is a joint endeavor between FDA and the University of Maryland, will be holding a workshop on TSE risk in relation to source materials, processing and end product use. The workshop will consider what is known and what's critical to learn about the potential risk of TSE transmission in these kinds of products. I think the answers that you all are going to try to provide to us to the questions on today's agenda, will also go a long way to helping us deal with some of those issues. I hope that all of you will be able to attend the June workshop as well. The sponsors include among others, the Virginia-Maryland Regional College of Veterinary Medicine, and we have representatives from international, academic, manufacturing and governmental organizations.

So, you have an enormously full agenda and I don't want to take up any more of your time. I just did want to say that on behalf of the Commissioner, the Acting Commissioner, Dr. Friedman and myself, and all of us in the Office of the Commissioner, we very, very much appreciate the effort and the commitment that you're putting into helping us with some very difficult and very complex issues. Thank you.

CHAIRMAN BROWN: Thank you, Ms. Holston.

The next item on the agenda is an open public hearing. I'd like to ask Bill Freas to proceed from here for a few minutes.

DR. FREAS: Dr. Brown, we had published an announcement of this meeting in the Federal Register, at that time asking anyone who was interested that we would afford them the opportunity this morning. I have not received any responses to the Federal Register notice.

Is there anyone in the audience at this time who would like to come and address the Committee.

I see no responses at this time. We will have two more open public hearings. If you would like to speak at one of those two open public hearings, please see me during the break or during lunch or after today's meeting. The other two open public hearings are scheduled on your agenda for 11:00 a.m. tomorrow morning and 3:45 p.m., tomorrow afternoon. So, if you'd like to speak at those, please see me.

Dr. Brown, I turn it over to you.

CHAIRMAN BROWN: Now we kick off the tallow seminar with Dr. John Bailey who is the Director of the Office of Cosmetics and Colors in the Center for Food Safety and Applied Nutrition. He will provide us our initial background information on the topic of the day, "Tallow and Tallow Derivatives."

DR. BAILEY: While we're setting up the overhead projector, I'd like to ask Dr. John Honstead to elaborate a little further on the June workshop concerning transmissible spongiform encephalopathies.

DR. HONSTEAD: Good morning. I'm John Honstead. I'm a veterinarian with the Center for Veterinary Medicine, NFDA.

I want to reiterate what Ms. Holston has already said. These announcements are out on the front table. This is going to be a very positive effort to accomplish relative to understanding TSE risks. This workshop is going to be held at the University of Maryland. It's going to consider what is known and what is critical to learn about the risk of TSE transmissions and it's going to cover three primary areas: source materials, processing and the use of the end products.

The purpose is to define the state of current knowledge and to identify practical guiding principles for evaluating the risks posed by transmissible spongiform encephalopathies. There's a registration form on the back of this announcement. There is also guidance for sending in and presenting a poster. We have the speakers set, but there's still a lot of communication that can be done. The evening of the first day is going to be dedicated to viewing posters. The second page tells you how to get your poster submitted. It would be very useful to have a good assortment of posters.

So, we invite you to register for this meeting. It's June 8th and 9th, again, in College Park, Maryland at the University of Maryland. Thank you.

DR. BAILEY: Thank you, John.

Good morning. I would like to welcome the members of the Transmissible Spongiform Encephalopathy Advisory Committee, the speakers, the audience, and to thank you for participating in this meeting of the Committee.

I would also like to thank the FDA Planning Group with Drs. Asher, Hellman, Chiu, Fang, and Honstead, and Ms. Vincent for their considerable efforts in organizing this meeting, and to Don Carrington and Lark Lambert of the Center for Food Safety and Applied Nutrition for their help. And of course, to Dr. Freas and also to Lynn Larsen who is the executive secretary for the Food Advisory Committee for their organizational and coordinating skills.

This meeting of the TSE Advisory Committee continues the Agency process of assuring the safety of FDA regulated products with regard to the risk to health posed by transmissible spongiform encephalopathies. This remains a challenging issue because of the continuing evolution of scientific knowledge about these agents. Last April, the Committee considered the safety of gelatin in FDA regulated products. The question then was "should FDA continue to exempt gelatin from restrictions imposed on other FDA regulated products in light of new information about inactivation of the TSE agent during manufacture?" In this meeting, we will focus our attention on the safety of tallow and tallow derivatives which, like gelatin, is a processed ingredient.

What I would like to do is to provide, as introduction, a chronology of events and a little bit more background information so that you'll have this information as you hear the other presentations and deliberate on this issue.

Bovine spongiform encephalopathy is a transmissible, progressively degenerative neurological disease of cattle similar to scrapie in sheep. Other such diseases are Kuru, Creuzfeldt-Jakob disease in humans, scrapie in sheep and goats, chronic wasting disease in deer and elk and transmissible mink encephalopathy. These diseases, collectively known as transmissible spongiform encephalopathies are characterized by an incubation period of several years during which there is no visible indication of disease, a relatively short clinical course of neurological degeneration, and eventual 100 percent death. There is no known treatment or cure and there are only limited methods for determining whether or not a non-symptomatic animal is infected.

Since BSE was first diagnosed in Great Britain, more than 170,000 cattle from approximately 33,000 herds have been diagnosed with the disease. BSE has been reported in native cattle in France, Switzerland, Portugal, Republic of Ireland, Northern Ireland, the Netherlands, Belgium and Luxembourg. Because of our concern about possible risk to health, FDA beginning in 1992 issued a number of letters to manufacturers of FDA regulated products requesting that bovine derived materials from cattle in countries designated by the USDA as countries where BSE exists not be used in the manufacture of FDA regulated products.

I'll summarize these briefly. In November of 1992, we sent a letter to manufacturers of dietary supplements expressing concern about the use of brain, nervous tissue and glandular ingredients in these products. In December of 1993, we sent a letter to the manufacturers of drugs, biologics and medical devices requesting that bovine derived material from BSE countries be avoided. This request excluded pharmaceutical grade gelatin.

In August of 1994, we sent a letter to manufacturers of FDA regulated products for animals requesting that bovine derived materials from BSE countries be avoided. In another letter sent at the same time to manufacturers and importers of dietary supplements and cosmetics, the Agency recommended that products containing certain bovine tissues and extracts of other ingredients derived from these tissues not come from BSE countries. FDA excluded dairy products, gelatin and meat from this recommendation.

The same letter also explained that USDA had issued regulations to prohibit the importation into the United States of certain tissues and organs from ruminants from BSE countries to protect livestock in the US. The USDA regulations permit under conditions, the importation of collagen, collagen products, amniotic liquids or extracts, placental liquids or extracts, serum albumin and sera colostrum derived from ruminants from BSE countries for use in cosmetics. The USDA regulations do not apply to the imports of Finnish cosmetic products, bovine derived materials intended for human consumption as either Finnish dietary supplement products or as ingredients in dietary supplements or human food.

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