1

2 FOOD AND DRUG ADMINISTRATION

3 PUBLIC HEARING

4

5 Substances Prohibited From Use in Animal Food

6 or Feed

7 Animal Proteins Prohibited in Ruminant Feed

8

9

10 TRANSCRIPT OF PROCEEDINGS OF PUBLIC HEARING

11 The Public Hearing concerning Substances

12 Prohibited From Use in Animal Food or Feed and

13 Animal Proteins Prohibited in Ruminant Feed

14 commenced at 9:00 a.m. on the 30th day of

15 October, 2001, at the Century Ballroom, Westin

16 Crown Center Hotel, One Pershing Road, Kansas

17 City, Missouri.

18

19 PANEL MEMBERS: Dr. Murray Lumpkin

20 (Presiding Officer)

21 Dr. Kathleen Akin,

22 Dr. Delia Parham,

23 Dr. Stephen Sundlof,

24 Dr. Stephen Solomon,

25 Dr. Dan Machesney

1

1

2 INDEX OF SPEAKERS

3 Page

4 Dr. Michael K. Hansen 14

5 Mr. David Miller 27

6 Dr. J. P. Fontenot 37

7 Mr. James H. Hodges 46

8 Mr. Michael Langenhorst 52

9 Dr. Don A. Franco 59

10 Mr. Robert A. Frish 65

11 Mr. Kevin Custer 83

12 Mr. Dennis Griffin 85

13 Mr. David Kaluzney 88

14 Mr. Gerald F. Smith 96

15 Dr. Gary G. Pearl 102

16 Mr. Richard Sellers 108

17 Mr. Joseph M. Garber 119

18 Mr. Brad Gottula 128, 154

19 Mr. Ben Jones 133

20 Mr. Randall C. Gordon 149

21 Mr. Mark L. Hohnbaum 165

22 Mr. Michael F. Malecha 169

23 Mr. Steven Roach 176

24 Mr. Chuck Massengill 189

25

2

1 DR. LUMPKIN: I would like to

2 call this Part 15 hearing to order, if I could.

3 Everyone who wishes to be part of the audience,

4 please be in their places.

5 I am Murray Lumpkin. I\'m the

6 acting deputy commissioner of the FDA, and I

7 will be the presiding officer at this particular

8 public hearing.

9 I would first like to thank

10 each and every one of you for taking time out of

11 your schedules to be with us today to have this

12 opportunity for us and our colleagues from the

13 Department of Agriculture to hear your comments,

14 to hear your concerns, to hear your thoughts on

15 this issue that is obviously of extreme

16 importance to all of us.

17 I\'d also like to take a moment

18 and especially thank three people who really did

19 all of the hard work for getting this particular

20 meeting set up. Those people are Tywanna Paul

21 from the FDA Kansas City district office, who

22 really, as far as I understand, did all the

23 logistical work.

24 And Tywanna, could you stand

25 up.

3

1 This is the person, if you have

2 any questions about logistics or about what\'s

3 happening here today, please feel free to ask

4 her, because she\'s the one who has all the

5 logistical answers.

6 Thank you very much, Tywanna.

7 We appreciate it.

8 I\'d also like to thank Bill

9 Sedgwick, who\'s the deputy district director

10 here in Kansas City, and all of his staff, whom

11 you met outside, who were working so hard to get

12 you checked in and try to meet your various

13 needs while you\'re here.

14 I\'d also like to thank Linda

15 Grassie from the Center for Veterinary Medicine

16 from Washington. She has been the person from

17 CVM who\'s been working with our Kansas City

18 colleagues to get this particular meeting

19 organized and get all the logistical work done.

20 So all the praise for this

21 particular meeting in this room and everything

22 that went into it clearly goes to those three

23 individuals. And a special thank you to all of

24 you.

25 For those ever you who might

4

1 not have ever been to or taken part in what we

2 call a Part 15 hearing, let me take just a

3 couple of minutes to try to review for you what

4 the purpose of this meeting is and how these

5 hearings are conducted.

6 These are general public

7 hearings that the FDA conducts under our

8 regulations. They are simply to provide a forum

9 that, when there are issues that are of extreme

10 importance to the FDA, when we are beginning to

11 look at how we do certain things in our

12 business, when we\'re beginning to look at our

13 rules and regulations, when people are raising

14 issues about the adequacy of rules, regulations,

15 procedures, it gives us an opportunity to put

16 that information out and to tell the public that

17 these are the kinds of things we\'re hearing,

18 these are the kinds of things that we have

19 questions about and concerns about, and, before

20 we get into any kind of formal rule-making, to

21 hear from the public what they think about these

22 issues and where they think we need to go \-- or

23 perhaps don\'t need to go \-- on a given issue.

24 And that\'s really what the purpose of this

25 meeting here today is.

5

1 As we said in the Federal

2 Register that went out announcing this meeting,

3 there were a whole host of issues relative to

4 our present feed-back rule that we have some

5 questions about. I think as all of you are

6 aware, this particular rule was promulgated back

7 in 1997. We\'ve had a four-year, four-and-a-

8 half-year experience with it now, and in that

9 period of time much new has been learned about

10 BSE and CJD and variant CJD.

11 We\'ve seen BSE spread now into

12 continental Europe, we\'ve seen it spread into

13 Japan, and because of these things I think we

14 felt like it was an appropriate time to look

15 back and to ask ourselves whether our present

16 feed rule is, indeed, adequate. The answer

17 could be yes. It could be that it\'s perfectly

18 adequate, that it does what it\'s intended to do,

19 and that no changes in it are needed. It could

20 be that, indeed, it needs to be tweaked, that

21 there are things that we\'ve learned, there are

22 things that we haven\'t done as well as a larger

23 community as we thought we could when that rule

24 was promulgated, and so we need to know that.

25 As all of you know, the process

6

1 for looking at that rule begins with this Part

2 15 hearing. We\'ll get a lot of different

3 viewpoints today, and that\'s okay. That\'s the

4 purpose of this.

5 If the decision is that,

6 indeed, perhaps some changes in the rule are

7 necessary, we would go forward with a

8 proposed \-- with what\'s called a Notice of

9 Proposed Rule-Making where any changes in the

10 rule would be specifically outlined and any new

11 wording for a revised rule would be printed for

12 public comment. After that public comment came

13 in, then the process is such that we would go

14 forward with issuing a final rule that would,

15 indeed, promulgate any changes, if, indeed, any

16 changes were needed as we go along.

17 So this is not the end of a

18 process today; this is clearly just the

19 beginning of a longer process if, as I said, the

20 consensus or the idea at the end of the day is

21 that our present rule needs to be tweaked to

22 meet the new knowledge and the new contingencies

23 that we have.

24 In a Part 15 hearing, as I

25 said, the purpose of a Part 15 hearing is for us

7

1 up here on the panel, representing different

2 parts of the federal government, to listen to

3 what you all have to say. This is not a forum

4 for us to announce new policies, to say this is

5 where we think we\'re going or where we don\'t

6 think we\'re going. This is really a chance for

7 you to tell us what you think we need to be

8 doing relative to the issues that are germane to

9 the topic today.

10 One of the rules of Part 15

11 hearings is that when your colleagues get up to

12 speak, you cannot cross-examine them. This not

13 a time to have he said/she said/they said and

14 have it go back and forth in the audience. And

15 I think in the many Part 15 hearings that I\'ve

16 been part of, people have been very respectful

17 of that. They\'ve noted that there are people

18 who have different opinions. And, indeed, this

19 is one of the glories of our system, that we

20 have an opportunity to come forward and give

21 those opinions, knowing that everyone who gives

22 their opinion will be shown the respect they

23 deserve. And I will assure you that will be the

24 way this particular hearing is conducted.

25 After a person speaks and gives

8

1 his or her opinion, people in the panel here are

2 free to ask clarifying questions to follow up,

3 that kind of thing. But I am going to try to do

4 the best I can to keep us on time. As you can

5 tell from the agenda, we have a fairly full

6 agenda. People have been limited to a maximum

7 of fifteen minutes. As you get close to that

8 fifteen minutes, I will \-- we don\'t have any red

9 lights or anything like that, but once your

10 fifteen minutes is up, I will interrupt people

11 and ask them at that time to start to bring

12 their presentation to a close.

13 I hope all of you will be

14 respectful of each other. I hate for us to go

15 over early in the morning such that people who

16 are scheduled later in the afternoon feel rushed

17 or feel like they\'re not going to have the time

18 that they deserve to have.

19 By law one of the things that

20 we have to do with these hearings is to provide

21 at least an hour where people who have not

22 registered to talk have the opportunity to talk.

23 In the Federal Register we announced that that

24 hour would be the hour between 4:00 and 5:00.

25 So we will be in session at least until 4:00 in

9

1 case someone read that the public session for

2 people who were not registered begins at 4:00

3 and shows up at that time. If, indeed, we have

4 no one at 4:00 who wishes to speak as an

5 unregistered speaker, then I will close the

6 session at that point in time. But we will be

7 in session until 4:00 to meet that contingency

8 of our procedure here.

9 Having said that, let me take a

10 few minutes here and just introduce my fellow

11 panel members. I think most of you probably

12 know these individuals, but for those of you who

13 don\'t, starting on my far right here is

14 Dr. Kathleen Akin. She is from the USDA from

15 the APHIS part of USDA. She is a member of the

16 TSE working group at USDA. And she is the area

17 veterinarian in charge at the Lincoln, Nebraska,

18 post of USDA. And she will be the APHIS

19 representative on the panel today.

20 The lady sitting directly to my

21 right is Dr. Delia Parham. She\'s from the

22 Office of Public Health and Science at the Food

23 Safety Inspection Service in Washington, D.C.

24 So she\'ll be the FSIS representative here today.

25 And these are my two USDA

10

1 colleagues who are part of this federal

2 government panel. The gentleman sitting to my

3 left \-- to my far left is Dr. Steve Solomon. He

4 is the deputy director of FDA\'s Office of

5 Regional Operations in Rockville, Maryland.

6 And to my immediate left is

7 Dr. Steve Sundlof, who is the director for FDA

8 Center for Veterinary Medicine. So Dr. Solomon,

9 Dr. Sundlof and I are the HHS/FDA

10 representatives to this panel.

11 There is also a group of

12 individuals who are in the audience with whom we

13 at FDA meet on a quarterly basis. These are

14 representatives from AAFCO, the American

15 Association of Feed Control Officials, and also

16 NASDA, the National Association of State

17 Departments of Agriculture. And we\'ll be

18 meeting with them tomorrow morning in a closed

19 session, a session between state and federal

20 government officials. And they are here with us

21 today to listen and also to hear what you have

22 to say, because, as you know, they play a

23 crucial role in this particular regulation and

24 enforcement of this regulation.

25 And so I\'m going to introduce

11

1 the ones that I know who are supposed to be

2 here. If they\'re here, I\'d like to ask them to

3 stand when I call their names so you know who

4 they are, and you can speak to them if you wish.

5 First is Fred Daley, who\'s the

6 director of the Ohio Department of Agriculture

7 in the far back.

8 Second is Benjamin Jones, Ben

9 Jones, who\'s with the Texas Feed and Fertilizer

10 Control Services. Ben is over here.

11 Ali Kashani from the State of

12 Washington Department of Agriculture. Ali \--

13 there\'s Ali over there.

14 Steve Martin from the Michigan

15 Department of Agriculture. Steve is up here.

16 Eric Nelson from the Wisconsin

17 Department of Agriculture, right there.

18 James Watson, who is the State

19 Veterinarian with the Mississippi Department of

20 Agriculture and Commerce.

21 And finally Steven Wong from

22 the California Department of Food and

23 Agriculture.

24 Thank you all.

25 And we also have one

12

1 international member of our group, Linda

2 Morrison, from the Canadian Feed Inspection

3 Agency. And Linda\'s back there.

4 So if you all have issues or

5 concerns you would like to express to them

6 relative to their national or state

7 responsibilities, by all means do that.

8 Are there any logistical

9 questions or anything that people have about how

10 we\'re going to proceed today before we get

11 started?

12 (No response.)

13 DR. LUMPKIN: Okay. According

14 to my watch \-- which I did set on Central time

15 this morning \-- it is 9:15, and according to our

16 agenda we should be ready for our first

17 spokesperson.

18 So I\'d like to call Dr. Michael

19 Hansen, who is a research associate for

20 Consumer\'s Union. And let me say to Dr. Hansen

21 coming forward, if I misrepresent your title or

22 mispronounce your name, I apologize. At this

23 point, please do correct it for the record.

24 As all of you know, on these

25 hearings we do make a verbatim transcript. Our

13

1 transcriptionist, the court reporter, is up

2 here. Please do speak up and only speak into a

3 microphone so that she can indeed hear what you

4 have to say.

5 Thanks very much. And I turn

6 the floor over now to Dr. Hansen.

7 Thank you for being with us.

8 DR. HANSEN: Thank you very

9 much. I\'m glad to be here, and I actually would

10 like to \-- Consumers Union would like to thank

11 the FDA for holding this hearing. I also would

12 like to say that we are going to submit written

13 comments to the docket, so I don\'t have any

14 prepared testimony that I will hand out.

15 But we do think that the FDA

16 needs to dramatically \-- well, needs to change

17 the rule and to actually expand it.

18 I am going to go through a

19 little bit of some of the old science and new

20 science which raises concerns for us, and then

21 try to go through a number of these questions

22 and give our responses to them.

23 For some of the old science

24 that I think we have to look at, in our mind,

25 the rule is too restrictive by just dealing with

14

1 BSE and new variant CJD. We, in fact, think

2 that the agencies here should be concerned with

3 pretty much all forms of TSEs and other forms of

4 CJD besides the new variant. All forms of CJD

5 there should be concern over.

6 And here\'s some of the science

7 behind why we have those concerns.

8 First for some of the old

9 science, there\'s something called the Gibbs

10 Hypothesis after Clarence Gibbs at NIH. And he

11 pointed out that probably the TSE that we

12 understand the best is Creutzfeldt-Jakob disease

13 in humans. It\'s been studies for quite a while,

14 and we know that it occurs supposedly at the

15 rate of one death per million population per

16 year. Now, it\'s been pointed out in the United

17 States that about fifteen percent of all the

18 cases of Creutzfeldt-Jakob disease are so-called

19 familial cases. And what those are is those are

20 people that have quaint mutations in the prion

21 gene. And as we all know, the prion protein

22 that which is thought responsible for this

23 disease \-- that is, the mouth form version of

24 that prion protein \-- the normal version is

25 found on the surface of all nerve and many

15

1 lymphocyte cells within all mammals. So we know

2 that in humans if you have a point mutation at a

3 given amino acid on that prion protein, it

4 somehow changes it to make it appear to

5 spontaneously flip over, so that people with

6 those mutant genotypes, they spontaneously come

7 down with CJD and they pass it on to their

8 offspring as though it were a dominant trait.

9 So since that happens with

10 humans, there\'s no reason to suspect \-- since

11 all mammals and all animals have these prion

12 proteins, there\'s no reason to suspect that

13 similar mutations can\'t also happen at random.

14 That\'s why Dr. Gibbs always said that he

15 actually expected that at a very low rate, one

16 in a million, one in two million, one in three

17 million, they would expect to see TSEs in

18 virtually all mammals. And he thought that the

19 reason that that wasn\'t \-- that we don\'t have

20 evidence of that is because who would notice a

21 slightly ataxic wild animal once it has subtle

22 symptoms?

23 So I think there\'s \-- because

24 of the fact that you can have mutations in the

25 prion gene that we know lead to disease,

16

1 regardless of any kind of outside input in terms

2 of what the organisms, what the humans, are

3 eating, that that suggests that the same thing

4 could happen in other mammals. We should be

5 concerned, for example, in cattle in the U.S.,

6 not just about BSE coming from Britain, but

7 there might be a TSE already existing in cattle

8 in this country.

9 In fact if you look, there is

10 indirect evidence of a native TSE in cattle in

11 the U.S. And the evidence comes from two

12 sources: One from the transmissible meat

13 encephalopathy outbreaks. That\'s TSE that

14 occurs in meat. There\'s been a number of

15 outbreaks in the United States. The first one

16 which really raised concern of scientists was

17 in \-- well, two of them. In 1961, there was an

18 outbreak on five farms in Wisconsin. They were

19 able to \-- and they were in adjoining counties.

20 All the farms with affected animals used a

21 ready-mix feed ration which came from the same

22 feed plant, so the scientists assumed that the

23 feed source was the source of this infection

24 agent, but there was many things in this

25 ready-mixed feed, so they couldn\'t tell.

17

1 Two years later, in 1963, there

2 were two more cases of TME outbreaks on mink

3 ranges in Wisconsin. This occurred on two farms

4 that were about two counties apart. And when

5 they went and looked, they found the one

6 surprising thing was that, quote, \"Beef

7 carcasses unfit for human consumption\" or

8 so-called downer cows, that came from Farm A

9 were fed to minks both on Farm A and Farm B. As

10 the scientists noted \-- this is Dr. Gary

11 Hartzog, Diedra Berger, they said, quote, \"Since

12 mink on both farms developed the disease almost

13 simultaneously, we believe this feed component

14 has to be incriminated.\" In fact, the following

15 year, in 1964, at the NIH-sponsored meetings on

16 TSEs and scrapie, Drs. Berger and Hartzog were

17 there hypothesizing that there were sporadic

18 cases of a bovine TSE occurring in the U.S.

19 under the clinical picture of downer cows.

20 We flash forward to the next

21 case that happened in Stetsonville, Wisconsin 22

22 years later, in 1985. Dr. Richard Marsh

23 investigated those cases. In that case, 95

24 percent of the diet was downer cows. He did a

25 lot of experiments in the lab and was able to

18

1 show that you could take brains from these

2 animals and just feed them to mink, the mink

3 would come down with the disease. For the

4 people that thought that TME was coming from

5 scrapie, he tried to get scans on every scrapie

6 strain he could find, and he could never

7 transmit it orally to mink. But they were

8 successful with this cattle.

9 So there was the evidence from

10 TME, and then also there\'s been evidence from

11 the scrapie-infested cattle studies. The first

12 one that took place in Mission, Texas, where

13 they injected scrapie into ten cattle in the

14 \'70s, what happened is two to four years later

15 three of the animals died, but they didn\'t

16 show \-- there wasn\'t classic spongiform damage

17 in the brain. So at the time, some of the

18 scientists said, \"No, we don\'t think this is

19 TSE.\"

20 Ten years later, in the late

21 \'80s, when they finally had the antibodies, they

22 were able to go in, check the brain cells of ten

23 animals, and, sure enough, the three that died,

24 they tested positive. And actually Gibbs was

25 able to take brain material from those animals

19

1 and transmit them to mice in the lab, showing

2 that they indeed were TSE. The clinical

3 symptoms were very different than TSE in

4 Britain, and, in fact, since then, there have

5 been further passages of mink from Stetsonville.

6 There have also been passages from Caterburg,

7 Wisconsin, and from North \-- Dakota Springs have

8 all been successful. So therefore that suggests

9 that there might be a TSE that\'s occurring in

10 the U.S.

11 Now, if you look at some of the

12 new science that is out there, that is pretty

13 frightening. In the last four years, NIH, the

14 lab in Montana, has been able to show with

15 studies with scrapie that was done in hamsters,

16 they found that some animals could be silent

17 carriers. They could appear perfectly healthy;

18 that is, you put scrapie into hamsters, they get

19 diseased. You inject the mice with hamster

20 scrapie, they live perfectly normal lives. They

21 are fine. When those mice die, you inject them

22 into other mice, nothing happens; but if you

23 inject them back into hamsters, the hamsters

24 come down with hamster scrapie with a longer

25 incubation period, which suggests that now you

20

1 can have silent carriers. So that means you can

2 have this indirectly; that is, if you feed

3 potentially contaminated, say, meat from a cow

4 that has a TSE, you can legally feed it to pigs,

5 grind up the pigs and feed the pigs back to the

6 cattle. So there\'s an indirect loop there that

7 raised a lot of concern at the time when these

8 studies came out, particularly in Europe. Also

9 some new studies that were also done in

10 Hamilton. DCN Petro conversion studies have

11 been able to demonstrate that BSE does convert

12 to human prion protein in the lab, and

13 furthermore it converts to prion protein \--

14 that\'s methionated code on 129 \-- three times

15 more efficiently than it is failing at 129. We

16 know that that fits with what we see because

17 met-met \-- if you have \-- if you\'re a met-met

18 homozygote at code on 129 prion protein for

19 humans, you\'re over-representing \-- you have a

20 higher chance of getting so-called sporadic CJD,

21 while recent studies have also demonstrated

22 chronic wasting disease which occurs \-- also

23 converts to prion, and it does it at about the

24 same rate that BSE does.

25 Finally, they were able to show

21

1 that scrapie did some converting at its human

2 prion proteins. Now, people would say scrapie

3 has been around for hundreds of years. There\'s

4 no evidence that it can cause any problems.

5 However, just last year, 2000, Corrine

6 Lasniecess\'s (phonetics) lab in France, doing

7 some strain type work, which is considered the

8 gold standard \-- and that\'s where you take the

9 TSE posivan and inject it into the brain,

10 certain genotypes of mice and then you look at

11 eight different areas of the brain and do a

12 score for the damage \-- they were able to show

13 with the strain typing that they\'ve been able to

14 differentiate many strains of scrapie, and, in

15 fact, this was what the final link that

16 convinced people that new variant CJD was BSE in

17 humans, because when you do the strain typing,

18 the new variant CJD caused one signature,

19 so-called sporadic CJD caused another one; but

20 new variant CJD looked exactly like BSE. When

21 they passed the BSE into mice, into felines or

22 wild ungulus in zoos, the strains all looked

23 identical.

24 So what the French did was they

25 had a bunch of growth hormone cases. They

22

1 decided to use some strain typing and try to

2 figure out maybe where some of those growth

3 hormone cases came from. And what shocked them

4 is one of the French cases, when they

5 strain-typed it, it didn\'t look at all like

6 variant CJD, but to their amazement, it looked

7 exactly like a French scrapie strain.

8 Now, they looked at a French

9 scrapie strain, sporadic CJD and variant CJD,

10 and what amazed them is now the strain-typing

11 evidence from this one athogenic case where it

12 strain-types out to a French scrapie strain \--

13 not a U.S. scrapie strain, but a French strain.

14 This was a French person that died of CJD from

15 growth hormone injections. So that does suggest

16 that strain-typing, that, in fact, that came

17 originally from sheep. And I know scientists in

18 Europe are very concerned about this.

19 There\'s also been four

20 case-controlled epidemiology studies which have

21 linked sporadic CJD to the consumption of brains

22 and other materials.

23 So because of this, we think

24 the present rule should be expanded; that is,

25 the additional objectives should be that we want

23

1 to minimize GSEs and new variant CJD. So we

2 think that the present day ban on mammalian

3 proteins in ruminant feed should be broadened

4 and the new parameters should be that all

5 mammalian proteins should be considered \--

6 should be banned, and none of those should be

7 permitted to be in the food fed to food animals.

8 So that is all mammalian proteins, with no

9 exceptions, and you broaden it to not just

10 ruminant feeds, but all food animals. That

11 includes fish and fowl now, of course, this fowl

12 protein and fish protein to be able to feed the

13 animals.

14 And as for the exemptions, I\'ll

15 go through those now. Therefore, we think this

16 exemption of pure porcine and equine protein in

17 your definition of \"mammal,\" that should be

18 revoked; that is, you should not be able to feed

19 the porcine, because the way it stands now,

20 again, there\'s an indirect route. You can feed

21 material from the cattle to pigs, grind up the

22 pigs and feed it back to the cows. So we think

23 the porcine and pure equine portion should be

24 revoked. The milk and dairy products, we think,

25 is fine. The blood and blood-clotted exemption

24

1 needs to be revoked because there is a \-- we

2 know that the TSE agent can be found in the

3 blood, and we also know that there is increasing

4 use of blood plasma and blood clot instances,

5 that weaning calves, that we don\'t think that\'s

6 a good idea. And finally the gelatin should be

7 revoked as well.

8 Now, there\'s also another

9 provision in that Section 589.2000 that we are

10 concerned with, and that was this provision that

11 says if you had a foolproof test for testing for

12 the presence of TSE \-- one doesn\'t exist yet,

13 but if you have it, if something tested

14 negative, then you would be exempt from their

15 requirements. But if something tested positive,

16 what we do with something that tests positive,

17 and under the present regulation, something that

18 tests positive can go into the animal feed

19 supply, it just needs to be labeled \"Do not feed

20 to cattle or other ruminants.\" We think that

21 that is crazy, and that any TSE-positive animal

22 should not be permitted into any food chain,

23 human or animal. We point out that that was the

24 first recommendation from the WHO expert

25 consultation that was held in 1996 on public

25

1 health impacts.

2 DR. LUMPKIN: Dr. Hansen, can I

3 ask you to wrap your comments up? Your fifteen

4 minutes are up.

5 DR. HANSEN: Yes. Very

6 quickly, we do think the \-- because of problems

7 with cross-contamination that the FDA should

8 require dedicated facilities for the production

9 of animal feeds. They should require dedicated

10 transport.

11 And then finally, one more

12 thing. For the recordkeeping requirements, they

13 presently stand at one year. That\'s inadequate.

14 We believe it needs to be ten years, because the

15 average incubation period, for example, for BSE

16 is five years. So you need to keep these

17 records so that if something happens you\'ll be

18 able to potentially trace the feed back to the

19 source. And given that BSE has an incubation

20 period between three and eight years, that there

21 are some forms of scrapie that are even longer,

22 we think we should account for ten years.

23 Finally, for the label

24 requirements, we agree with the FDA that we

25 think that the label should be simplified and

26

1 say, \"Not to be fed to cattle or other

2 ruminants,\" that that should all be spelled out.

3 And again, we\'ll do very

4 detailed comments to the entire group.

5 Thank you.

6 DR. LUMPKIN: Thank you very

7 much.

8 The next person who is

9 scheduled to speak is Mr. David Miller, the

10 director of the commodity services at the Iowa

11 Farm Bureau Federation.

12 As he is coming forward, as we

13 pointed out, people are encouraged to submit

14 written comments. The docket will remain open

15 for the reception of the comments until November

16 21st if you wish to get them into the docket.

17 Also, if you happen to have

18 either a written or electronic copy of your

19 presentation, Linda Grassie, who is sitting at

20 the end of the first table here, is collecting

21 those to have them put into the docket.

22 Thank you very much.

23 Mr. Miller, please.

24 MR. MILLER: Thank you.

25 The Iowa Farm Bureau Federation

27

1 appreciates the opportunity to provide oral

2 comments to the Food and Drug Administration in

3 regards to the rules governing animal feed and

4 regulations and the issues that FDA has raised

5 in the Federal Register.

6 Iowa Farm Bureau believes that

7 the current rule is generally sufficient to

8 provide necessary public health protection. We

9 believe that farmers and ranchers are taking the

10 appropriate steps to comply with the ruminant

11 feeding ban. As with any new rule that

12 radically changes production practices and

13 requires significant alterations in

14 recordkeeping and other management practices,

15 complete compliance was not instantaneous with

16 its implementation. We believe that compliance

17 with the ruminant feeding ban is at a high level

18 and increasing. However, it would be

19 appropriate for FDA, in cooperation with state

20 inspection programs, to maintain surveillance of

21 compliance through spot checks and records

22 review of regulated firms.

23 The ruminant feed ban rule was

24 part of a three-pronged approach to reduction of

25 risk as it pertains to introduction and spread

28

1 of BSE in the United States food supply. We

2 believe that the rule is adequate to meet its

3 objectives. Government studies have indicated

4 that the risk for introduction and/or spread of

5 BSE through cattle feed is near zero, especially

6 if we can achieve complete compliance. The FDA

7 arguments that were put forth at the time of the

8 adoption of the 1997 final rule were compelling.

9 Those arguments were based on sound science and

10 a review of industry practices. The basic risk

11 factors that the final rule aims to reduce are

12 essentially the same as in 1997, thus the

13 regulations that were deemed to be based on

14 sound knowledge and scientific fact should

15 continue to provide the level of risk reduction

16 being sought.

17 To date, we are not aware of

18 any scientific basis for broadening the ban on

19 the use of specified mammalian proteins in

20 ruminant feeds. In the preamble to the 1997

21 rule, FDA provided scientific justification for

22 the exemptions offered in the rule. We believe

23 those exemptions are still scientifically

24 justified. The safety of blood products has

25 been reconfirmed by scientific tests. We

29

1 recommend that FDA continue to monitor the

2 science and consider changes when there is

3 compelling scientific justification and

4 evidence.

5 We do believe that the feeding

6 of poultry litter and other recycled poultry

7 waste to cattle could present a means for the

8 spread of BSE, if the disease were ever found in

9 the United States. We recommend that FDA and

10 other appropriate agencies conduct the necessary

11 research to quantify the actual risks associated

12 with feeding of poultry litter and other poultry

13 wastes to cattle. If the risks are as minimal

14 as they appear to be, then no additional action

15 should be taken. If the risks are determined to

16 be significant, then the Iowa Farm Bureau would

17 consider supporting a modification to the

18 prohibited materials list to include poultry

19 litter and other poultry wastes.

20 We believe that \"road kill\" and

21 all ruminant wildlife should be eliminated from

22 all rendering. Such animals should be buried or

23 incinerated, but should not be allowed to enter

24 the feed supply chain. Domesticated deer, elk

25 and other such animals should be treated as any

30

1 other livestock species.

2 Imports of feed and animal

3 protein products should be restricted from those

4 countries with BSE or which are not actively

5 performing surveillance in accordance with the

6 Office of International Epizootics. We support

7 the regionalization of certain areas like the

8 European Union because of the free flow of goods

9 within and among member countries. We are

10 concerned, however, that insufficient attention

11 is being paid to transshipment of animal

12 products from restricted countries or areas

13 through third-party countries. We are also

14 concerned that such products may be mislabeled

15 when being transshipped. We urge the FDA to

16 strengthen the port inspection program and to

17 increase its surveillance of transshipments.

18 We believe that imported feed

19 products pose the greatest threat of

20 introduction of BSE into the United States. We

21 urge FDA to increase its efforts in this area,

22 giving it more attention and funding.

23 We believe FDA should consider

24 making some modifications in labeling

25 requirements. It is becoming standard industry

31

1 practice for producers to be required to certify

2 to those purchasing their cattle that they have

3 not been fed proteins derived from either

4 ruminant or mammalian sources. Many producers

5 have indicated that this is difficult if the

6 label does not at least distinguish whether the

7 protein in the feed is derived from ruminant or

8 non-ruminant sources. Currently producers do

9 not have sufficient information to really make

10 this certification. Feeds containing animal

11 proteins often only indicate that the feed

12 contains animal proteins. The producer must

13 assume what type of animal protein from the

14 presence or lack of a warning statement. We

15 believe this is insufficient. Producers should

16 have the necessary information to make the

17 certifications that the marketplace is

18 requiring.

19 Producers in Iowa are concerned

20 that the lack of specific information with

21 respect to the type of mammalian protein sources

22 could lead to producers making inaccurate

23 certifications. We believe broader

24 classifications of protein sources such as

25 \"non-ruminant-derived animal proteins\" and

32

1 ruminant derived animal proteins\" may be

2 sufficient, rather than species-specific

3 classifications. We do not believe it is

4 necessary for the label to list specific species

5 that a feed should be fed to. The current label

6 warning is understood by producers.

7 Previously, FDA has indicated

8 that the cautionary statement serves no useful

9 purpose on pet food and feed for non-ruminant

10 laboratory animals and cited this as one of the

11 bases for the current exclusion. Iowa Farm

12 Bureau is unaware of any changes in industry

13 practices or risks to food safety that have been

14 introduced because of this exclusion. We see no

15 need to remove the exemption and believe that

16 FDA\'s justifications of this labeling exemption

17 remain valid.

18 We believe that the imposition

19 of a requirement that dedicated facilities be

20 used for the production of animal feed

21 containing mammalian protein would provide

22 little, if any, reduction in risk, given the

23 extremely small number of commingling incidents

24 and the very low level of commingling.

25 Similarly, we believe that

33

1 imposition of a requirement that dedicated

2 facilities be used for the transportation and

3 delivery of animal feed containing mammalian

4 protein would provide little reduction in risk

5 given the extremely small number of commingling

6 incidents and the very low level of commingling.

7 Such a requirement, however, would impose

8 significant costs on the industry and would

9 reduce the number of feed manufacturers, thus

10 needlessly raising costs to producers. We

11 believe it would be very counterproductive to

12 initiate rules that could be construed to

13 prevent carrying a bag of dog food on the deck

14 of a feed truck hauling cattle feed to a farm.

15 We believe the current

16 authorities, penalties and other compliance

17 mechanisms available to state and federal

18 authorities are sufficiently adequate and

19 severe. No new penalties are necessary. If

20 additional resources are avilable to FDA for

21 compliance work, such resources should be

22 directed at inspection of facilities using

23 restricted-use protein products and for

24 improvement of overall surveillance. Imposition

25 of additional regulatory burden and paperwork on

34

1 the feed industry to implement a licensing

2 program would not be a wise use of agency funds.

3 We believe the federal

4 commitment to a full and ongoing inspection

5 program is vital to the success of the ruminant

6 feed ban as a risk mitigation tool in the fight

7 to keep the United States free of BSE. We

8 believe that we must have 100 percent compliance

9 and 100 percent inspections. This will require

10 state and federal agency cooperation as well as

11 industry action. We urge FDA to do a review of

12 the third-party certification programs that have

13 been developed by the industry. If, upon

14 review, these third-party certification programs

15 are deemed reliable and responsible, then we

16 would urge FDA to officially recognize and

17 cooperate with such programs.

18 In summary, we believe the

19 current rule governing the use of animal

20 proteins in ruminant feeds is, in general,

21 working well. Areas that might be considered

22 for modification to further reduce any potential

23 risks are restrictions on feeding of poultry

24 litter to ruminants and more extensive

25 monitoring of imported ruminant feeds. We urge

35

1 strong enforcement of current regulations, but

2 do not believe that additional regulations are

3 necessary to increase compliance. We believe a

4 federal commitment to a full and ongoing

5 inspection program supplemented with industry

6 certification programs are essential elements of

7 this effort to reduce the potential for

8 introduction of BSE and minimize the potential

9 for spread of the disease vector should it ever

10 occur in the United States.

11 We appreciate the opportunity

12 to provide these comments regarding the

13 prohibition of specified proteins from ruminant

14 feeds.

15 DR. LUMPKIN: Thank you, Mr.

16 Miller, for joining us.

17 Are there any questions of the

18 panel for Mr. Miller?

19 (No response.)

20 DR. LUMPKIN: And I didn\'t ask

21 the panel: Any questions of Dr. Hansen? I

22 forgot about that.

23 (No response.)

24 DR. LUMPKIN: Okay. Fine.

25 The next speaker is Dr. J.P.

36

1 Fontenot, who is the John W. Hancock, Jr.

2 professor of animal science at Virginia

3 Polytechnic Institute and State University.

4 Dr. Fontenot.

5 DR. FONTENOT: Thank you very

6 much, sir. And I appreciate the opportunity to

7 appear here to talk about the feeding of poultry

8 litter. The main reason I requested to appear

9 is that I had heard that there had been some

10 objections raised in terms of feeding poultry

11 litter in relation to BSE.

12 I\'ll have to crank up the

13 machine here. Just a minute. It takes a little

14 while.

15 This is what we\'re talking

16 about. In other words, here\'s where the poultry

17 litter is produced. We have many of those

18 throughout the U.S., especially in

19 poultry-producing states.

20 I\'ll give an outline of the

21 presentation. I\'ll talk a little bit about the

22 history of the poultry industry, the class of

23 cattle that are fed poultry litter, quality of

24 animal products, safety of feeding poultry

25 litter, and also look at regulations and

37

1 practical feeding.

2 These are the amounts of waste

3 that are produced per year. You\'ll notice that

4 somewhat over five million tons of poultry

5 litter are produced per year. In terms of

6 feeding poultry litter, it is fed mainly to beef

7 cows and stocker cattle. Little, if any, is fed

8 to fattening cattle. Substantial amounts are

9 fed in broiler producing states. In Virginia it

10 is estimated that 20 to 25 percent of the litter

11 that is produced is fed, which would amount to

12 somewhat over 100,000 tons. In the U.S. about

13 5.6 million tons of broiler litter are produced.

14 It would amount to \-- if we say twenty percent

15 is fed, that would amount to about one billion

16 tons per year. So it is a substantial amount.

17 Description of the poultry

18 litter. Poultry litter is an accumulation of

19 excreta, some wasted feed, feathers and bedding

20 material. Bedding material is usually wood

21 shavings, sawdust, peanut hulls or other fibrous

22 materials.

23 Options for utilizing animal

24 wastes. It\'s been applied to the soil for

25 centuries. It can be used also as a substrate

38

1 for methane generation from microbial and insect

2 protein hydrant. The most economically feasible

3 is one of feeding farm animals.

4 Nutritional value of poultry

5 litter. It is quite nutritious. It has 25 to

6 30 percent protein on a dry matter basis,

7 fifty-five to sixty percent TDN. It is rich in

8 minerals. If you want to compare it to, say,

9 feeds \-- feedstuffs, it would be at least

10 equivalent to good quality alfalfa hay or

11 higher; in other words, it\'s higher in protein,

12 it\'s higher in energy and it\'s higher in some of

13 the minerals, and the performance of animals fed

14 poultry litter has been equal to animals fed

15 traditional feeds if the nutrients were

16 equalized.

17 About the quality of animal

18 products from animals fed poultry litter. There

19 has been very extensive research. There have

20 been no differences, no deleterious effects on

21 the carcass quality. Furthermore, in cooking

22 and taste tests with animals fed poultry litter,

23 there has been no harmful affect on feeding the

24 litter on the taste of the meat.

25 Let\'s look at the safety, then,

39

1 of feeding poultry litter, which is one of the

2 things that we need to be concerned with. This

3 young lady here is cooking steaks for her

4 family, wants to make sure that it is safe.

5 The history of the poultry

6 litter feeding \-- this is a little bit out of

7 order. Poultry litter has been fed to beef

8 cattle for at least 40 years. The research on

9 feeding poultry litter started in the 1950s. We

10 started doing our work in 1963.

11 In residues \-- this is the

12 slide I was getting to \-- there have been no

13 accumulation of pesticide residues after a

14 one-day withdrawal, we found that there was no

15 accumulation of heavy metals, and after a

16 five-day withdrawal, although there were

17 medicinal drugs in the litter, there were no

18 medicinal drugs found in the meat or the litter.

19 So the meat has been found to be safe.

20 In terms of were pathogenic

21 organisms, there are potential pathogens. The

22 litter should be processed; however, there is no

23 information concerning BSE on poultry litter.

24 Processes that are effective to

25 process poultry litter: Dehydration, ensiling

40

1 and deep-stacking. I think you are all familiar

2 with ensiling and dehydration. Deep-stacking

3 would look something like on the next slide.

4 This is a large structure, and

5 many of those in the poultry-producing units

6 such as Virginia, where we have deep-stacking of

7 litter, it\'s stacked several feet high. It

8 undergoes the heat and does destroy the

9 pathogens.

10 Although poultry litter is a

11 potential source of pathogens, in a recent

12 Georgia report, they found no salmonella.

13 E.coli was isolated from 86 samples. Some of

14 that had been processed and had not been

15 processed. However the litter should be

16 processed to destroy any potential pathogens.

17 Clostridia problem, I would

18 like to address. In some countries there have

19 been outbreaks of botulism occurring in cattle

20 fed poultry litter. In all cases this was due

21 from Clostridium botulinum arising from poultry

22 carcasses in the litter. There have been no

23 cases reported in the U.S. I have followed the

24 cases very carefully in all other countries \--

25 I\'m not going to name them \-- but there\'s none

41

1 in the U.S. However, it is important to remove

2 the carcasses from the poultry house.

3 In terms of animal health in

4 the U.S., we have observed copper toxicity in

5 sheep and poultry litter. This is not a serious

6 problem in cases of cattle because they are not

7 nearly as sensitive as sheep to copper. As a

8 matter of fact, over a seventy-year period we

9 fed high-copper poultry litter to beef females

10 every winter for seven years, and we observed no

11 symptoms of copper toxicity. The liver copper

12 levels were up in the spring, but then after

13 they went to pasture the next fall, they were

14 back down.

15 Okay. In terms of regulation,

16 most states follow the Association of Feed

17 Control Officials in terms of their model

18 regulation, which means the waste must be free

19 of pathogens. If the waste does not contain

20 drug residues, no withdrawal period is required

21 and can be fed to any class of animal. If the

22 waste does contain objectionable residue, a

23 fifteen-day withdrawal is required.

24 Feeding poultry litter and BSE.

25 This question was addressed by FDA in 1998. The

42

1 code is given here. The question that was

2 raised was: Can chicken litter be fed to cattle

3 if poultry might have been fed prohibited

4 material? And the FDA\'s answer is yes. The FDA

5 has no evidence that the agent that causes BSE

6 would survive the chicken intestinal tract.

7 FDA expects the states to

8 require recycled animal waste to conform to the

9 definitions promulgated by AAFCO\'s publication,

10 which is described in the model regulation.

11 Practical feeding. As I said

12 earlier it is fed primarily to beef cows and

13 stocker cattle and is usually mixed with corn or

14 other palatable materials. Small amounts of hay

15 or straw is usually fed.

16 The value of poultry litter,

17 about a hundred dollars a ton, based on its

18 nutritional value as a replacement for hay. And

19 many times it is. It\'s worth about sixty to

20 eighty dollars per ton. Soil application, it\'s

21 worth about \$25 per ton, about four times as

22 much as a feed than a soil application.

23 Okay. One of the advantages in

24 the feeding of poultry litter to beef cattle.

25 For the meat producer it\'s an economical feed

43

1 and it\'s an alternative feed for such things as

2 during a drought. In some parts of the

3 southeast we are running into a serious drought,

4 and a lot of poultry litter is being fed as a

5 substitute for hay, because hay is becoming

6 short. From the poultry producer, it provides

7 excess soil application. From an environmental

8 standpoint, if we can transport litter further

9 from the production areas because of its value

10 and also keep the high level of nitrogen

11 phosphorous from going to the water supply due

12 to high excess levels of soil application.

13 In summary, then, we feel that

14 poultry litter can be used as a feed stuff if

15 processed properly. It is a safe feed.

16 Performance of cattle fed the waste is similar

17 to that of cattle fed traditional feeds. With

18 good management and appropriate withdrawal, the

19 litter does not result in harmful residues in

20 animal tissue. The higher value of litter as a

21 feed than fertilizer would justify

22 transportation of the waste outside of the areas

23 where it\'s produced.

24 We feel there is no reason to

25 change the regulation, and we feel that FDA

44

1 should stay with its original statements

2 published in 1998.

3 Again, thank you very much for

4 the opportunity to appear in this hearing.

5 DR. LUMPKIN: Thank you

6 Professor Fontenot.

7 Are there any questions of the

8 panel?

9 I have one, just since we\'ve

10 got a little bit of time. You mentioned the

11 composition of what we generically call poultry

12 litter. One of the things is spilled feed. Do

13 you have any idea quantitatively how much of

14 poultry litter consists of spilled feed?

15 DR. FONTENOT: I have no data

16 at all on that. But my impression is that with

17 the controlled conditions used, you know, by the

18 poultry industry today, we still do that \-- we

19 still say that. But the fact of the matter is

20 that when we made this statement, this was more

21 like thirty or forty years ago. I think with

22 the modern technology, it\'s \-- although I have

23 no measurements at all, I think it\'s very

24 minimal.

25 DR. LUMPKIN: Thank you, sir.

45

1 Thanks very much. We appreciate it.

2 The next person on our schedule

3 to speak is James Hodges. He is president of

4 the American Meat Institute and the AMI

5 Foundation in Arlington, Virginia.

6 MR. HODGES: Thank you,

7 Dr. Lumpkin.

8 Today I am representing the

9 American Meat Institute. We are the nation\'s

10 oldest and largest meat packing and processing

11 industry association. Our members slaughter and

12 process over ninety percent of the nation\'s

13 beef, pork, lamb, veal and turkey products, and

14 we produce more than sixty percent of the

15 rendered by-products that are manufactured for

16 animal feed in the United States.

17 We appreciate the opportunity

18 to comment on the FDA animal feeding regulations

19 that were put in place to help prevent the

20 establishment and amplification of BSE in the

21 U.S. cattle herd.

22 AMI has and continues to

23 support the scientifically based regulations

24 that restrict the use of animal protein derived

25 from mammalian tissues for use in ruminant feed.

46

1 A careful analysis of the facts suggests no

2 regulatory changes are warranted at this time.

3 I have three messages to leave

4 with you today:

5 First, we do not have BSE in

6 this country; second, we have taken prudent

7 steps to prevent BSE from entering country; and,

8 third, if BSE were to find its way into this

9 country, we can diagnose it, isolate it, and

10 prevent it from reaching consumers in a swift

11 and decisive way. Our risk of BSE from domestic

12 cattle is not zero, nor can it ever be. But our

13 risk today is the lowest it has ever been since

14 the disease was first recognized as a threat to

15 the U.S. cattle population. Any changes

16 contemplated in the regulations must take that

17 into account.

18 Let me focus for a moment on my

19 first message. We do not have BSE in this

20 country. That fact bears repeating because it

21 tends to get lost in the emotional reactions

22 that often surround a public debate on ways to

23 reduce the risk from BSE. Hysterical and

24 speculating news reporting that often

25 accompanies that debate further obscures the

47

1 successful track record that we have

2 established.

3 The BSE crisis in Europe, and

4 now Japan, has provided strong incentives for

5 the U.S. government and the U.S. beef industry

6 to take aggressive actions to prevent this

7 devastating disease. In fact, we took action so

8 early that some people now seem to question why

9 we aren\'t announcing new major efforts today.

10 The answer? We took swift, science-based

11 actions early on that have protected our

12 livestock and given us the coveted distinction

13 of being a BSE-free nation.

14 The purpose of this hearing is

15 to solicit information and views on FDA\'s animal

16 feeding regulation. But that cannot be done in

17 isolation. It is important to remember that BSE

18 prevention in the U.S. involves multiple

19 programs that can best be described as a triple

20 firewall strategy. This includes: One, a ban

21 on the importation of cattle and beef products

22 from countries with BSE; two, a statistically

23 sound and comprehensive animal surveillance

24 program to continually monitor for the presence

25 of the disease; and, three, ruminant feeding

48

1 restrictions to prevent the amplification and

2 spread of the infective agent in the unlikely

3 event BSE occurs in our domestic cattle.

4 Taken together, these efforts

5 provide the best reasonable assurance that U.S.

6 cattle will remain BSE-free, and that U.S.

7 consumers will not be exposed to any related

8 health risk. That is not to say we should rest

9 on our laurels. We must continually evaluate

10 and improve our preventative control measures if

11 warranted, and we must assure our regulatory

12 agencies are provided with the necessary

13 resources to do their job.

14 AMI believes the present FDA

15 animal feeding regulations are appropriate,

16 given the low level of risk that BSE will occur

17 in this country. Our goal is not to change the

18 regulation but to achieve 100 percent compliance

19 with the existing regulation. AMI\'s worked with

20 several trade associations to supplement FDA\'s

21 compliance activities by establishing a program

22 to certify that animals sold for slaughter have

23 not been fed any feed containing protein derived

24 from mammalian tissues that is prohibited by FDA

25 regulations. The program was implemented

49

1 earlier this year, and our internal surveys

2 indicate that a vast majority of the animals

3 that come to slaughter are marketed under these

4 types of certification programs. A copy of the

5 program details will be provided for the public

6 record.

7 Finally, it is important to

8 remember that BSE has been diagnosed only in

9 Europe and Japan. More than 99 percent of the

10 diagnosed BSE cases have occurred in Great

11 Britain, where the incidence rate has dropped

12 dramatically after animal feeding restrictions

13 were implemented.

14 The U.S. has very different

15 risk factors. Our livestock populations are

16 very different, as are our rendering, feeding

17 and production practices. In addition, these

18 countries are in the midst of a crisis, and

19 crises warranted strong and dramatic actions.

20 In contrast, we do not have a BSE crisis in the

21 U.S. It is critical that our BSE prevention

22 policies reflect that fact and that our policies

23 are supported by the best available science.

24 Again, I appreciate the

25 opportunity to present the views of the American

50

1 Meat Institute.

2 I\'ll be happy to answer any

3 questions the panel may have, and I will leave

4 copies of my prepared testimony for anyone in

5 the audience as well as for the public record.

6 DR. LUMPKIN: Thank you,

7 Mr. Hodges.

8 Any questions from the panel?

9 DR. SUNDLOF: Jim, you

10 mentioned that the significant percentage of the

11 cattle going to slaughter now are covered by the

12 certification programs. Do you have any kind of

13 statistics on that?

14 MR. HODGES: We don\'t have firm

15 statistics, but if you just survey our major

16 members, all of them are using \-- all of them

17 are using some type of certification program \--

18 if nothing else, to meet customer needs. So I

19 would stand by my statement that it\'s the vast

20 majority rather than put a particular number on

21 it at this point.

22 DR. LUMPKIN: Any other

23 questions?

24 (No response.)

25 DR. LUMPKIN: Again, thank you

51

1 Mr. Hodges.

2 The next speaker is Michael

3 Langenhorst. He\'s the past president of the

4 National Renderers Association, Alexandria,

5 Virginia.

6 MR. LANGENHORST: Thank you,

7 Dr. Lumpkin. I\'m also the president of the

8 Adamex Group of Companies in Green Bay,

9 Wisconsin. We are a renderer in Wisdonsin, so

10 the first eight minutes of my clock or

11 discussion will be on National Renderers

12 Association and the last two minutes will be on

13 behalf of myself and my company.

14 National Renderers Association

15 is the international trade association for the

16 industry that safely and efficiently recycles

17 animal and poultry by-products into valuable

18 ingredients for the livestock, pet food,

19 chemical and cosmetic industries. The NRA

20 represents 43 member companies operating more

21 than 160 rendering plants.

22 We are very familiar with the

23 issues we\'re discussing here today. Since the

24 first case of BSE was reported in 1986 and

25 through all the stages of the situation, we\'ve

52

1 been proactive and have worked closely with the

2 FDA and other government departments as well as

3 affiliated industries to produce and promote

4 safe feed. In fact, I believe that the support

5 of the National Renderers Association and our

6 TSE committee has been instrumental in the

7 success of the surveillance program as well as

8 the original rule itself.

9 There are seventeen questions

10 we\'ve been asked to respond to, but I would just

11 like to comment publicly on a few of them.

12 Written comments will be submitted by our

13 industry before November 21st.

14 The main question is: What

15 additional enforcement activities, if any,

16 regarding the present rule are needed to provide

17 adequate public health controls? Are there any

18 suggestions for ways to improve compliance with

19 the rule?

20 The NRA believes that the

21 current rule provides adequate protection for

22 public health and has accomplished its intended

23 goals as laid out in 1997. We realize that

24 there are big concerns expressed with certain

25 aspects of the rule, but feel that these

53

1 concerns can be addressed by providing proper

2 resources for inspections and data management.

3 There have been very few

4 noncompliance events since the rule has been

5 implemented. The majority of noncompliance

6 issues come from incorrect inspection

7 interpretation or incorrect data compilation.

8 In fact, the recent APPI third-party

9 certification program has shown a 98 percent

10 compliance with the rule in the rendering

11 industry. The other two percent have not been

12 determined not compliant, but, rather, have not

13 undergone third-party certification.

14 The NRA strongly supports and

15 would participate in any effort to attain 100

16 percent compliance of our industry. We would

17 not be opposed to licensing a rendering facility

18 as it relates to compliance with the rule if

19 this would help with enforcement so long as it

20 does not become a bureaucratic nightmare. If

21 anyone is not complying with the rule,

22 appropriate action needs to be taken by the

23 agency.

24 Much time and energy went into

25 developing the final rule in 1997. It was felt

54

1 very strongly at that time that appropriate

2 controls had been implemented to protect public

3 health in the United States.

4 The rule is based on scientific

5 risk assessment and was deemed to satisfy the

6 risk at that time. It must also be remembered

7 that the rule at that time was thought of as a

8 firewall for the meat industry. We all know

9 that the U.S. really has many firewalls in place

10 relative to the BSE: The ban on imports since

11 1989, the surveillance program which exceeds OIE

12 recommendations, mammalian feed ban of 1997 and

13 now thirty-party certification.

14 We\'re at the lowest level of

15 risk that we have ever been as a country.

16 There\'s no need to reopen the rule, but rather

17 we must strive for 100 percent inspection and

18 compliance with the current rule.

19 The NRA strongly supports

20 appropriate restrictions on the importation of

21 feed and animal products. These restrictions

22 should be based on a risk analysis and on a

23 country\'s BSE incidence. The U.S. could

24 accomplish this by establishing a category

25 classification as practiced in other parts of

55

1 the world. The resulting import restrictions

2 and policies would be based on the systemic

3 classification category.

4 Coordination of programs and

5 appropriate financial resources must be put in

6 place to accomplish this initiative.

7 The NRA thanks you for this

8 opportunity to address these issues. We are

9 committed to protecting our public health and

10 continue to be available to work with the FDA.

11 As stated earlier, our common goal is to attain

12 100 percent compliance.

13 I would also like to present to

14 the panel a third-party report that we have just

15 had done for the rendering industry by the

16 Sparks Company. And this is an economic impact

17 for three scenarios.

18 Scenario 1 is a total animal

19 protein ban \-- feed ban to all ruminant

20 animals. The total reduction in revenue to

21 industry \-- now, this is not a rendering issue,

22 this is an animal agriculture issue. And I\'m

23 standing here as a renderer, but we all have to

24 keep in mind that I\'m not here trying to protect

25 the rendering industry. What we\'re talking

56

1 about here is animal agriculture. The total

2 affect of an animal protein feed ban in all

3 ruminant animals is over \$100 million a year.

4 Scenario 2 is a total ban on

5 feeding of ruminant protein to all farm animals,

6 including ruminant meat and bone meal to swine

7 and poultry and ruminant blood meal and plasma

8 to dairy, beef, swine and poultry. The total

9 net reduction to animal agriculture of value

10 would be about \$636 million.

11 Scenario 3 is a total animal

12 protein ban for all farmed animals.

13 There\'s a lot more involved

14 with these things than just a dollar impact, but

15 also the environmental impact. As much as 47

16 billion pounds of slaughter by-products could

17 accumulate each year, or 64,000 tons each day.

18 That means the rendering is going to continue.

19 The product will probably be rendered and then

20 still have to be dispossessed of. The effect on

21 the economic impact of animal agriculture under

22 that scenario is about 1.519 or 1.52 billion

23 dollars year. So that will also be submitted as

24 part of our report.

25 Let me change my hats very

57

1 quickly now and talk as a director of his own

2 business and his own company to be concerned

3 about. Even though I have been speaking on

4 behalf of the rendering industry, it\'s not a

5 rendering issue; it\'s an animal agriculture,

6 public health and a common sense issue. But

7 really it\'s an animal agriculture issue.

8 It must be remembered that meat

9 and bone meal are the not the product of BSE,

10 but rather was involved in the transmission of

11 BSE. The feed ban in \'97 eliminated that

12 threat. Meat and bone meal is still a safe

13 feed.

14 I\'d just like to make the

15 comment that animals are not ground up to affect

16 other animals, as we heard earlier. Material is

17 processed under time and temperature

18 requirements and is considered that it is turned

19 to protein meal, much like soybean meal. It

20 could be safely fed to other food animals. It

21 was safe before \'97 and it is safe today. The

22 only thing that\'s changed is that we\'re no

23 longer feeding mammalian protein to ruminants.

24 This was done as a precaution, not because meat

25 and bone meal was considered a poison, a toxin

58

1 or a carcinogen, even though people treated it

2 as a poison, a toxin or a carcinogen.

3 This needs to be kept in mind

4 as the technology continues to improve. There

5 needs to be attention paid to this in the

6 future. Zero tolerance for a safe feed product

7 is unwarranted. We\'ve been taught to work from

8 history, and the rendering industry has. We

9 will not go down the slippery slope of the

10 Europeans, trying to separate so-called good

11 product from bad product. We are not Europe,

12 but rather we\'re North America. We do not have

13 BSE.

14 Thank you.

15 DR. LUMPKIN: Thank you,

16 Mr. Langenhorst.

17 Are there questions?

18 (No response.)

19 DR. LUMPKIN: Thank you, sir.

20 The final speaker before our

21 break this morning is Dr. Don Franco. He is

22 president of the Animal Protein Producers

23 Industry from Lakewood, Florida.

24 DR. FRANCO: Thank you,

25 Mr. Chairman.

59

1 The Animal Protein Producers

2 Industry is the association of the United States

3 rendering industry that is responsible for

4 biosecurity, and, as a result, the establishment

5 of programs to ensure feed ingredient safety,

6 including animal proteins that are used as

7 ingredients in livestock, poultry, agriculture

8 and pet foods.

9 In this capacity, the

10 organization has followed the subject of bovine

11 spongiform encephalopathy from the report of the

12 initial outbreak in the United Kingdom in 1986.

13 APPI is conscious of the complexity of the group

14 of diseases collectively defined as the

15 transmissible spongiform encephalopathies and

16 fully recognizes the tentative nature of the

17 science and the fact that BSE is the first

18 disease in the annals of regulatory medicine,

19 animal or human; that a rule was written with

20 all the finite determination and affirmation of

21 the cause of the disease. While this was

22 unusual, APPI recognized at the time that the

23 uncertainty of the circumstances mandated a

24 necessity to establish a series of flexible

25 controls that are in the best long-term

60

1 interests of animal and human health, and as a

2 result, supported the agency in the quest to

3 format a rule that would preclude any likelihood

4 of the transmission or amplification of the

5 infectious agent of BSE and ultimately the

6 protection of the country\'s public health.

7 About 16 years after the

8 initial report of BSE, we are still discussing

9 the varied nuances of the diseases, including

10 the current questions posed by the agency in

11 their consideration of options, including

12 aspects/concepts for modification, if

13 applicable, of the existing rule.

14 While the complex issues and

15 unanswered concerns of BSE mandate caution, the

16 record clearly indicates that instituted

17 controls in the United States started in 1986,

18 immediately after the confirmatory diagnosis and

19 continuing today in a constant manner by

20 recently promulgated import restrictions

21 are effective. Cumulatively, governmental

22 policies are working and provide ample

23 assurances that adequate constructive measures

24 and controls are in place to ensure the safety

25 of animal protein feed ingredients destined for

61

1 the feed food chain.

2 This assurance analogy is best

3 exemplified by the final rule that became

4 effective on June 5, 1997, and commonly referred

5 to as the \"animal feeding regulation.\" This

6 comprehensive rule has addressed the potential

7 hazard/risks associated with the disease and

8 thus establish a visionary protocol to prevent

9 the likely transmission and amplification of

10 this infectious agent.

11 The rule was an excellent

12 proactive response for public health protection

13 at the time it was written. And in the absence

14 of any changes in the risk factors of this

15 country, remains so today. The regulatory

16 agency developed a systematic method for

17 education, inspection, for compliance, and

18 enforcement, and collaborated with the states to

19 assure success of the spirit and intent of the

20 rule. APPI, therefore, as an organization, sees

21 no need for any modification or reopening of the

22 objectives or contents of the rule.

23 Retrospectively, the risk

24 factors in the United States for a BSE incident

25 are actually the lowest since the associated

62

1 links to the outbreak was first described in

2 1987-88 by epidemiologists in the United

3 Kingdom. This has been affirmed in the peer

4 review professional journals by APHIS, USDA

5 officials, and in the Service\'s own brochures

6 and publications.

7 The epidemiological case

8 definition for the BSE outbreak in the United

9 Kingdom has been clearly articulated by the

10 following postulates. For an indigenous case of

11 BSE to occur, a simultaneous \-- and I say

12 simultaneous \-- presence of three factors is

13 required: One, a large sheep population in

14 relation to that of cattle, with a significant

15 level of endemic scrapie; two, conditions of

16 rendering that allow the survival of significant

17 amounts of infectivity and; three, the use of

18 substantial quantities of meat and bone meal

19 from affected sheep or cattle in cattle feed.

20 The addition of a fourth factor

21 applies to countries without the disease and has

22 obvious relevance to the United States.

23 Countries without BSE may also acquire it by the

24 importation of live animals that could be

25 incubating the infectious agent of the disease

63

1 or the importation of contaminated meat and bone

2 meal that could be subsequently fed to

3 susceptible cattle. Fortunately, our

4 established rules in the last fifteen years have

5 addressed the potential risk from a worst-case

6 assessment and thus creating an impenetrable

7 firewall to prevent, again, the likely

8 transmission or amplification of the infectious

9 agent, and, as a result, the protection of

10 animal and human health in the United States.

11 APPI, then, is committed to the

12 success and compliance with rules that advance

13 the principles of our security, sustainable

14 animal agriculture, food safety and the

15 protection of human health. We pledge our

16 resources to make this commitment a reality by

17 working with FDA to achieving that objective.

18 We treasure the opportunity to

19 be here and will provide further statements

20 comprehensively in writing.

21 In closing, I reflect on

22 historical debate that has been taking place in

23 this country for the past 72 years. Although

24 the disease differs dramatically from BSE, there

25 were groups that have indicated since 1929 that

64

1 one day we are going to have a outbreak of

2 foot-and-mouth disease in this country. Again,

3 that is likely.

4 The message is that our

5 regulatory agencies are apparently doing some

6 things right. This applies to BSE. Not

7 everything that should happen in life will

8 happen. Applied to the science of disease

9 transmission, unless the risk factors are

10 present, cause and effect, Mr. Chairman, will

11 not be realized.

12 I thank you.

13 DR. LUMPKIN: Thank you,

14 Dr. Franco.

15 Are there any questions for

16 Dr. Franco?

17 DR. SUNDLOF: Yes, have I one.

18 Don, you and, I think, two or

19 three other speakers have said that the risk at

20 this time is at an all time low for the

21 introduction of BSE to this country. Can you

22 list some of the factors that account for that?

23 I mean, the rule is in place. We have import

24 bans, we have our three firewalls. Are there

25 other things based on the epidemiology of the

65

1 disease or other contributing factors that have

2 led you to the conclusion that the risk is lower

3 than it has been?

4 DR. FRANCO: Well, I did start

5 off by looking at the complexity of the

6 diseases, and I am very conscious of that.

7 However, if you look at the things that first,

8 by the industry, voluntary controls. In 1989,

9 at Lonnie King\'s office, the rendering industry

10 committed not to process sheep. And we went out

11 and did just that, because that was the only

12 available knowledge at the time. It was

13 voluntary, and we did it. We then went out and

14 we looked at other aspects of our security. We

15 looked again at what was happening in Europe.

16 We have been to Europe. We have been to Europe

17 many times. We looked at research. But these

18 diseases are, by nature, very, very complex.

19 The answers don\'t come readily. So what we did,

20 we looked at the rule, what you imposed on us.

21 Some of the suggestions were hazard analysis,

22 use of pathogen food safety. And I don\'t know

23 what else we could do as an industry. I mean,

24 we also looked at what was not done in Europe

25 and did a comparative analysis of what we did.

66

1 And I think, again, without being repetitious or

2 in any way redundant, that we have done what we

3 need to do, both as an industry and as a

4 government.

5 Thank you.

6 DR. LUMPKIN: Thank you again,

7 Dr. Franco.

8 We have reached the time for

9 our break. There is coffee and other things in

10 the back. Please avail yourselves of it. And

11 we will restart at a quarter till. So we\'ll

12 restart the hearing at 10:45. Thank you.

13 (A recess was taken.)

14 DR. LUMPKIN: If I could ask you

15 to take your seats, we\'ll get started here.

16 Before we get started with the

17 next group of presenters, Dr. Sundlof asked to

18 make a few comments, so I am going to turn the

19 meeting over to Dr. Sundlof for a few minutes.

20 DR. SUNDLOF: Thank you, Mac.

21 I just wanted to say that the

22 reason that I think we kept BSE out of this

23 country is thanks to a lot of the folks in this

24 room who have been very active and supportive of

25 the feed rule and trying to do the best job that

67

1 you possibly can in making sure that it has been

2 enforced and that folks are complying with it.

3 So I know you don\'t get enough

4 credit for the things you do, and I just wanted

5 to pass that along, that we couldn\'t do this

6 without the help of the states, without the help

7 of the various agricultural industries who play

8 a major role in this.

9 We will be releasing today a

10 CVM update which contains the latest compliance

11 figures for the feed rule, and they have

12 improved from the report that we issued in July.

13 In July we had an overall

14 compliance, when we considered all the

15 industries, the renderers, the licensed feed

16 mills and unlicensed feed mills and some

17 miscellaneous others, like ruminant feeders and

18 et cetera, we had an overall compliance rate of

19 about \-- well, about 22 percent of the firms

20 were not in compliance. You see the update that

21 will show that about thirteen percent of the

22 firms are not in compliance. So we\'re up to 87

23 percent compliance rate. Again, most of those

24 are the unlicensed feed mills that seem to still

25 have the highest rate of noncompliance. In

68

1 those firms that were found to be out of

2 compliance on one inspection, on reinspection

3 only six percent of them are continuing to

4 remain out of compliance. So the numbers are

5 going in the right direction. I think that\'s

6 very good. As has been said a number of times

7 this morning we still need to get that

8 compliance rate up to a hundred percent. Looks

9 like we\'re on the right trajectory.

10 DR. LUMPKIN: Thank you, Steve.

11 Our next speaker is Mr. Robert

12 A. Frish, who is corporate counsel for Darling

13 International, Incorporated, of Irving, Texas.

14 MR. FRISH: Good morning

15 Mr. Chairman. I am Robert Frish, corporate

16 counsel for Darling International, Incorporated,

17 a rendering company with its corporate offices

18 located in Irving, Texas. I\'d like to thank you

19 for opportunity to comment on behalf of Darling

20 International on the status of the FDA\'s

21 prohibition on the use of mammalian proteins in

22 ruminant animal feeds. Please be advised that

23 Darling International will be submitting written

24 comments supplementing today\'s presentation that

25 more thoroughly responds to the agency\'s notice.

69

1 Ensuring biosecurity and the

2 safety of the food supply is an overriding

3 concern for Darling International. Every year

4 the American rendering industry provides a vital

5 societal service in protecting animal and human

6 health, effectively controlling or preventing

7 the spread of diseases associated with animal

8 tissues by removing and processing close to 50

9 billion pounds of animal and poultry by-products

10 generated by the livestock, meat and poultry

11 industries. As one of the largest independent

12 rendering companies in the United States,

13 Darling safely collects and processes more than

14 seven percent of the total volume of these raw

15 materials through its facilities located in 22

16 states.

17 In 1997, the FDA prohibited the

18 use of mammalian tissues in ruminant animal

19 feeds as a precautionary measure in order to

20 prevent the transmission of TSE diseases to

21 ruminant animals, such as BSE, despite the fact

22 that BSE has never been detected and remains

23 undetected in the United States. Even while

24 acknowledging the abundant scientific

25 uncertainty that existed as to the origin and

70

1 transmissibility of the disease, the FDA

2 nonetheless adopted the rule as a measure to

3 prevent, quote, \"The establishment and

4 amplification of the disease should it ever

5 occur in this country,\" unquote. The agency

6 further determined that the absence of

7 compelling scientific evidence did not warrant

8 any other protein feed ingredients other than

9 specified proteins derived from mammalian

10 tissues in ruminant animal feeds.

11 Darling International believes

12 that the scope of the current rule sufficiently

13 meets its stated objectives. Experts agree that

14 feed safety must be built on risk-based

15 scientific expertise. There is currently no

16 compelling risk-based scientific evidence to

17 support expanding the current feed ban to

18 include other rendered materials, eliminating

19 the exemptions for certain ruminant proteins

20 previously determined to present no risk, such

21 as blood and blood products, or to prohibit the

22 feeding of rendered proteins provided by

23 ruminant animals to other animal species. The

24 current rule, surveillance program, import

25 restrictions and marked differences in animal

71

1 production and feeding practices between the

2 United States and European countries

3 collectively make the likelihood of BSE

4 occurring in the United States negligible.

5 There is therefore no need to reopen the rule,

6 and to do so is not scientifically justified nor

7 warranted.

8 Rather than altering the

9 current scope of the rule, the agency should

10 consider addressing the way in which they follow

11 and enforce the rule\'s parameters. Much in the

12 current surveillance system could have been

13 avoided had the FDA initially mandated the

14 licensing of rendering facilities. At the time

15 of the rule\'s inception, the agency would have

16 known who the renderers were and what materials

17 were handled and produced by each facility. The

18 agency would have also been able to distinguish

19 transfer stations that handle commingled

20 materials for a processing facility and

21 nonrendering plants, such as those handling used

22 cooking oils to produce yellow grease and feed

23 fats, and would have disregarded them from

24 unnecessary inspection criteria. Many states

25 currently issue state rendering licenses and

72

1 permits to operate. So additional federal

2 licensing requirements would not have presented

3 an undue burden provided clear guidelines were

4 established. Licensing could also assist in

5 advancing the rendering industry\'s credibility.

6 It is up to the rendering

7 facility to determine what type of facility it

8 will be, depending not only on the raw materials

9 handled but the type of finished proteins it

10 seeks to produce. Just because a facility

11 handles exempt raw materials such as porcine or

12 poultry meal does not mean that it is going to

13 sell exempt material. Once the facility

14 declares whether it will handle exempt raw

15 material only, exempt and non-exempt raw

16 materials in a manner consistent with the rule

17 or commingled raw materials as restricted-use

18 proteins, guidelines could be created to

19 delineate the compliance parameters that must be

20 adhered to.

21 At the same time, FDA

22 compliance inspectors should be trained to be

23 familiar with rendering facility operations and

24 how such operations are performed under the

25 rule. Too often the inspectors are unfamiliar

73

1 with how the facility operates or inspect for

2 issues that are not covered by the rule,

3 resulting in erroneous notations of

4 noncompliance for that facility. FDA, APHIS and

5 members of the rendering industry should

6 consider jointly developing training and

7 educational program that would set forth the

8 rendering plant compliance inspection guidance

9 for federal inspectors. Properly trained

10 inspectors would further eliminate erroneous

11 noncompliance citations and yield more accurate

12 inspection data.

13 Penalties for noncompliance

14 could be created ranging from warnings, monetary

15 sanctions, injunctions and criminal penalties

16 based on the particular licensing criteria that

17 the FDA would establish.

18 When the FDA established the

19 rule, it was noted that it would implement the

20 vigorous enforcement program designed to prevent

21 use of proteins derived from mammalian tissues

22 in ruminant animal feed. It was the agency\'s

23 intent to create a mechanism designed to limit

24 the ability of the BSE to develop in this

25 country. The rule provides this agency with the

74

1 ability to issue injunctions and post criminal

2 penalties and seize, adulterated or misbranded

3 product. However, to date enforcement

4 activities for noncompliance with the rule has

5 amounted to little than the issuance of warning

6 letters. Moreover, the agency\'s compliance and

7 inspection reports reflect inconsistent

8 enforcement of the regulations established by

9 the rule.

10 In order to ensure that the

11 rule measures up to the FDA\'s intended goal, the

12 FDA must be willing to diligently enforce

13 compliance with the tenets of the rule in a

14 consistent fashion. Instead of expanding the

15 scope of the current rule to include more items

16 subject to inconsistent surveillance and

17 enforcement programs, the FDA should develop and

18 adhere to a strong enforcement policy that not

19 only mandates compliant behavior but also

20 penalizes noncompliance accordingly. Clear and

21 concise enforcement guidelines providing for

22 monetary penalties for noncompliance must be

23 established, along with provisions for other

24 actions, such as mandatory recalls,

25 cease-and-desist orders and suspension of

75

1 operations until noncompliant actions are

2 corrected or abated.

3 If you\'re going to have

4 inspectors out there, it is important that they

5 be thoroughly and properly trained in all

6 nuances of the regulatory requirements to ensure

7 consistency and credibility in inspection

8 activities. Matters that are not governed by

9 the rule should not be part of the scope of the

10 investigations unless there is a direct impact

11 on compliance, such as the measures in place to

12 prevent commingling of materials. Special

13 attention should focus on familiarizing

14 inspectors with the rendering process to avoid

15 inconsistent inspections and the subsequent

16 dissemination of misinformation related to the

17 industry compliance to the rule.

18 There\'s a problem with sending

19 out field staff to conduct inspections who view

20 their role as simply information gatherers and

21 they don\'t know the boundaries of what to

22 inspect. The inspectors openly acknowledge that

23 they know nothing about the rendering industry

24 or the facilities that they inspect. They

25 conduct the inspection of a company for

76

1 compliance to a rule that they themselves are

2 uncertain how that operation is supposed to

3 behave in order to be in compliance.

4 The inspectors are fact-finders

5 who ask questions with an investigatory slant

6 that may or may not be germane to the issues of

7 compliance to the rule. All of the information

8 generated by their investigation is sent up the

9 line for someone else to interpret. This often

10 includes the information gleaned that has no

11 direct bearing on compliance. This type of

12 information, otherwise irrelevant to compliance,

13 is posted by the agency without proper

14 interpretation and stimulates unnecessary and

15 otherwise unwarranted public concern.

16 The inspection data posted by

17 the FDA on their web site most show compliance

18 or noncompliance for inspected facilities and

19 disregard information that does not have any

20 relevance to compliance. If the published

21 inspection reports indicate whether or not a

22 facility is compliant with the rule, the

23 public\'s perception of compliance will improve.

24 It would also be extremely

25 worthwhile for the agency to provide prompt

77

1 feedback to the managers of inspected

2 facilities. Regarding their compliance status

3 to the rule, currently many managers do not know

4 the inspection results until after the agency

5 has posted its findings on the internet.

6 Increased communication with regulated parties

7 will increase likelihood of compliance with the

8 rules.

9 One issue of paramount concern

10 that is outside the scope of the current rule is

11 the status of the raw material itself. When the

12 rule was first promulgated, dead ruminant

13 animals and unprocessed ruminant-derived

14 viscera, bone, fat trim, meat trim, blood and

15 other animal products and by-products that are

16 deemed to be inedible or unsuitable for human

17 consumption were mainly handled and processed by

18 the rendering industry. Yet over the years

19 economic conditions and unforeseen marketing

20 changes have negatively impacted the rendering

21 industry, precipitated in part by the rule,

22 coupled with rising international concern about

23 BSE and pressure from Europe on the

24 international community to adopt E.U. food

25 safety principles and policies. As a result,

78

1 rendering facilities now charge for their

2 services. This has prompted an increasing

3 number of animal producers, locker plant

4 operators, meat processors, and retail food

5 chains to utilize alternative methods for the

6 disposal of these raw materials. In short, the

7 percentage of these raw materials that are

8 collected and processed by the rendering

9 industry is steadily declining. If it doesn\'t

10 go to a rendering facility, do you know where

11 this material will end up?

12 The origin and ultimate

13 disposition of raw materials are not traceable

14 when methods other than rendering are used.

15 Rendering companies already possess the

16 necessary infrastructure to allow for trace-back

17 of raw materials and trace-forward of finished

18 products. Only rendering companies are held

19 accountable and required to document and

20 maintain written records suitable for

21 governmental agencies to trace raw materials

22 back to their source and the finished products

23 forward to the end user.

24 The current rule only prohibits

25 the intended inclusion of proteins derived from

79

1 mammalian tissues in ruminant feeds. Ruminant

2 materials that are disposed of through

3 nonrendering means such as composting, landfill

4 or on-site burial can still enter the food chain

5 by a variety of means. The spread of composted

6 materials of ruminant animal origin on land that

7 is used for livestock grazing and/or hay

8 production is permissible under the current

9 rule. Domestic and wild animals, including

10 ruminants, may have direct exposure to

11 unprocessed ruminant raw materials that have

12 been improperly buried, composted or placed in

13 landfills. This is of particular concern

14 because scientists believe that chronic wasting

15 disease, a TSE affecting deer and elk, is

16 transmitted when healthy animals are exposed to

17 soil contaminated by the remains of an infected

18 animal. It is believed that the soil can remain

19 contaminated for decades. The unregulated use

20 of nonrendering alternatives could lead to the

21 amplification of the disease that the rule was

22 implemented to prevent in the first place.

23 While incineration is a viable

24 option for disposal of these raw materials, it

25 is both costly and environmentally unsuitable.

80

1 Other alternatives to rendering for the disposal

2 of raw materials, such as composting, on-site

3 burial or landfills, do not provide adequate

4 biosecurity with respect to BSE as well as other

5 infectious diseases. The best means of

6 attaining and maintaining biosecurity is to

7 regulate the disposition of all raw materials of

8 ruminant origin by having licensed rendering

9 facilities collect, transport and process them

10 in order to limit exposure of domestic and wild

11 ruminant animals to these raw materials. The

12 regulation of these raw materials can be

13 established independent of and in addition to

14 the present feed rule.

15 In conclusion, before the FDA

16 expands the scope of the rule and/or removes any

17 exempt products from the list, in the absence of

18 compelling scientific evidence, to do otherwise

19 the agency should make certain that it has done

20 everything it can do under the current terms of

21 the existing rule.

22 The agency should focus on how

23 to improve performance and compliance under the

24 present rule parameters. There should be

25 better-developed and concise surveillance and

81

1 enforcement guidelines established by the

2 agency, including the development and

3 implementation of an appropriate penalty

4 schedule that would mandate compliance. Federal

5 compliance inspectors must be properly trained

6 both in nuances of the rule and how the rule

7 applies to the industry that they inspect.

8 Establishment of federal licensing guidelines

9 would further assist the agency in this

10 direction.

11 Most of all, the agency must

12 address the need to regulate the raw materials

13 from the outside by requiring that only licensed

14 renderers collect, transport and process the

15 materials. To permit continued disposal of

16 these materials through nonrendering means

17 undermines the intent of the rule; that is, to

18 prevent the establishment and amplification of

19 the disease should it ever occur in this

20 country.

21 Thank you.

22 DR. LUMPKIN: Thank you,

23 Mr. Frish.

24 Are there questions?

25 (No response.)

82

1 DR. LUMPKIN: Thank you again.

2 The next speaker is Mr. Kevin

3 Custer. He vice president of technical services

4 for American Proteins, Incorporated, in Cumming,

5 Georgia.

6 MR. CUSTER: I\'d like to thank

7 the agency for the opportunity to make comments

8 on this issue. Today I am representing American

9 Proteins, a renderer in Georgia and Alabama,

10 processed poultry by-products. I have a brief

11 statement which I will read and will present for

12 the record.

13 The final rule established at

14 Section 589.2000 has the stated objective to

15 prevent the establishment and amplification of

16 the agents of bovine spongiform encephalopathy

17 in the United States cattle through feed and

18 thereby help minimize any risks from such agents

19 to animal or human health. The objective has

20 been and is being met.

21 In addition to the rule, other

22 safeguards are in place to meet the objective of

23 the rule. APHIS/USDA introduced import

24 restrictions very soon after the initial Great

25 Britain diagnosis, and over the years has added

83

1 to those restrictions as warranted. FSIS/USDA

2 has submitted over 12,000 cattle from nearly

3 every state and Puerto Rico for examination with

4 no evidence of BSE or TSE found.

5 In addition to government

6 initiatives, several industry programs have been

7 initiated, most notably third-party

8 certification administered by Cooke and Thurber

9 for rendering and animal protein blending

10 facilities. A compliance rate of 98 percent was

11 noted, two percent difference from a hundred

12 percent. It\'s reported there are facilities yet

13 to be inspected.

14 In summary BSE does not exist

15 in the United States. Broadening the list of

16 animal proteins prohibited is not warranted by

17 scientific scrutiny.

18 And I would again like to thank

19 the agency for this opportunity. If there\'s any

20 questions, I\'d be happy to answer them.

21 DR. LUMPKIN: Thank you,

22 Mr. Custer.

23 Are there any questions from

24 the panel?

25 (No response.)

84

1 DR. LUMPKIN: Thank you, sir.

2 The next speaker is Mr. Dennis

3 Griffin. He is chairman of the Griffin

4 Industries, Incorporated, in Cold Spring,

5 Kentucky.

6 MR. GRIFFIN: Thank you.

7 Ladies and gentlemen, I\'m here

8 to submit my testimony today in response to your

9 agency\'s request for comments on the possibility

10 of opening up the regulation that was then

11 listed in Federal Register on October 5th, 2001.

12 I\'m speaking today on behalf of

13 our family business, Griffin Industries, which

14 has been in the rendering business for over 58

15 years. We are based in northern Kentucky and

16 serve many animal agricultural members

17 throughout the midwest, the southeast and the

18 southwest part of our country. Our company is

19 in full compliance of the ruminant-to-ruminant

20 food regulation and HACCP programs in all its

21 processing facilities, and it is participating

22 in the Animal Protein Producers third-party

23 certification program, which, with increased

24 plant and procedure inspections, has helped

25 bolster FDA\'s inspection program.

85

1 I wish to begin my comments by

2 saying that BSE has not been detected in the

3 United States. It has been over fifteen years

4 since the first known case of BSE was discovered

5 in the United Kingdom, with many thousands of

6 confirmed cases throughout Europe. The disease

7 has been a European-domiciled disease, with only

8 one other case reported in other sections of the

9 world, but it had ties with European suppliers.

10 We strongly support the

11 existing action taken by your agency in June of

12 1997 to build a firewall against BSE and see no

13 reason to change or modify CFR 589.2000.

14 We as Americans have a good

15 program in place, and, with continued awareness

16 and enforcement by your agency, will provide our

17 consumers the continued confidence they need in

18 U.S. meat products.

19 The highest awareness level in

20 food safety history has been created by actions

21 taken by the agency and by industry such as the

22 ruminant-to-ruminant feed ban, the ongoing

23 testing of suspect animal brain, which is

24 currently approaching sixteen thousand animals

25 that have been tested. The industry\'s

86

1 third-party inspection program has our industry

2 participation of over 98 percent \-- unheard of

3 in past practices.

4 Being in this industry for over

5 40 years, I\'ve never experienced such an effort

6 on the part of animal agriculture, and

7 especially our industry, and working so closely

8 with your agency in this precautionary program

9 against this foreign disease.

10 Since the discovery of the

11 first BSE case in 1986, scientists still do not

12 have clear evidence for the cause of BSE or the

13 new version in humans, or that BSE has ever

14 crossed species boundaries. There are new

15 theories and hypotheses developing throughout

16 the world as more research takes place. And

17 with that, I\'m sure that there will be a true

18 cause of BSE discovered in the near distant

19 future.

20 In closing, we support working

21 with the current regulation and increased effort

22 for enforcing it. Changing the rules sends a

23 wrong message to consumers and protein users

24 domestically as well as internationally that

25 something is wrong with our current efforts.

87

1 And this is clearly not the case. If it isn\'t

2 broken, don\'t try to fix it. Remember, we have

3 not discovered any BSE in the United States, and

4 with fifteen years behind us without any

5 detection, further changes to our safety

6 measures are unwarranted.

7 Thank you for giving us the

8 opportunity to respond. And if you all have any

9 questions\...

10 DR. LUMPKIN: Thank you,

11 Mr. Griffin.

12 Any questions from the panel?

13 (No response.)

14 DR LUMPKIN: Thank you, sir.

15 The next speaker this morning

16 is Mr. David Kaluzny from Kaluzny Brothers,

17 Incorporated, Joliet, Illinois.

18 MR. KALUZNY: Thank you,

19 Mr. Chairman.

20 Kaluzny Brothers is a

21 55-year-old independent rendering firm serving

22 the northern half of Illinois, Southern

23 Wisconsin and Northwest Indiana. We process

24 bones, fat, offal and hides from both ruminant

25 and nonruminant animals, as well as various

88

1 greases. I will refer to my questions as they

2 were numbered within the request for data.

3 Number 1. We do not see any

4 need to change the enforcement activities of the

5 agency. Rather, more importantly, we see a need

6 to improve the accuracy and completeness of the

7 reporting of the agency\'s inspections. We feel

8 this reporting has done more to cause concern

9 amongst the public than any actual noncompliance

10 with the rule that has actually occurred.

11 Number 2. This question really

12 asked: Is the rule doing its job? And we feel

13 yes, it is. Its intent was to create an

14 additional firewall around our beef industry.

15 As we sit here now, we do not have BSE in this

16 country. I dare say we never will. This

17 disease first emerged fifteen years ago and has

18 never been found in this country. And today

19 99.999 percent of all cases have been confined

20 to Europe; 99.9 percent in England, the other

21 0.99 percent in the rest of Europe and only one

22 case in Japan.

23 Furthermore, as a country we\'ve

24 been vigorously looking for signs of this

25 disease by examining thousands of cattle breeds

89

1 every year. We have never found BSE. It seems

2 to me, again, the rule is working.

3 The ban should not be broadened

4 in any way either. It works now, and, more

5 importantly, there is no new scientific evidence

6 that has come forth in the past four years that

7 in any way would suggest that we make any

8 changes.

9 Number 4. The FDA should not

10 require dedicated facilities for the production

11 of animal feeds containing mammalian proteins.

12 The current rule already addresses the issue of

13 prevention of commingling quite adequately.

14 Procedures and controls are already in place and

15 being used to prevent commingling and

16 contamination in rendering facilities.

17 Number 5. The agency should

18 not require dedicated transportation for animal

19 feed containing mammalian proteins. This issue

20 as it relates to commingling or cross-

21 contamination is, again, already addressed

22 within the rule and, at the same time, is

23 currently not a problem. To require such at

24 this time would only needlessly add to costs

25 while not adding to any further protection of

90

1 animal feed.

2 Number 6. We would not oppose

3 FDA licensing of renderers as it relates to the

4 current rule in effect, CFR 589.2000.

5 Number 7, the FDA should not

6 revoke or change any of the current exclusions

7 allowed for in the rule. There is, again, no

8 new scientific evidence that has come forth that

9 would even remotely justify any such move.

10 Number 8. The FDA does not

11 need to add to the list of prohibited materials

12 and language relating to poultry litter. The

13 rule addresses protein from mammalian tissue,

14 and, as such, already addresses this issue.

15 Further elaboration or definition would only

16 serve to confuse.

17 Number 9. No, the exemption

18 should not be removed for pet food either. It

19 is not normally fed to animals for human

20 consumption.

21 Number 10. The current

22 recordkeeping requirement, in light of annual

23 and sometimes biannual inspections, seems

24 adequate at one year. If, however, the agency

25 can see a need for further data beyond a year,

91

1 we would support such a move if it makes the

2 rule any better.

3 Number 11. The FDA should not

4 change the rule to require labeling of the

5 specific type of mammal used in the production

6 of a specific protein. Such a need is

7 nonexistent in light of the requirement to label

8 \"Do not feed to cattle or other ruminants.\"

9 Beyond that, this would only serve to confuse

10 feeders, feed mills, blenders, cattlemen and

11 nutritionists who already have a fully

12 understood list of feed ingredients they work

13 with and that are used nationwide.

14 Number 12. The current

15 cautionary statement should stand as is. It is

16 clear, to the point and well understood. It was

17 designed that way. If, however, the agency

18 knows of individuals feeding deer, elk or bison

19 with prohibited proteins, I would support such a

20 change. However, I don\'t know of any with such

21 animals feeding them any animal proteins, and I

22 know of no such commercially available feed for

23 that purpose either.

24 As far as I know, number 13,

25 there is no currently available accurate and

92

1 efficient analytical method for detecting

2 prohibited mammalian protein in feeds.

3 Number 14. I see no need here

4 for any more enforcement authority; rather, an

5 assurance that all inspectors, state and

6 federal, are working, quote, unquote, out of the

7 same songbook, so to speak would help keep

8 uniform assessment across the country.

9 Number 15. Private

10 certification programs have worked tremendously

11 in the rendering industry. Through APPI we have

12 engaged the use of Cooke & Thurber of Madison,

13 Wisconsin, to certify, plant by plant, renderer

14 compliance with the rule, and therefore intent

15 and actual manufacture of safe feed ingredients.

16 We had the honor of being the first plant to go

17 through the compliance audit, and we were proud

18 to do so. Just as important, third-party audits

19 also give the agency the ability to point to an

20 outside entity that can verify compliance with

21 the rule.

22 Number 16. Regarding the

23 importation of feed ingredients, the

24 restrictions should be based on the incidence or

25 non-incidence of BSE in the country of origin.

93

1 Number 17. Regarding what

2 additional measures could be taken to further

3 guard against BSE, I offer the following. I

4 will not offer any views on preventing CJD or

5 variant CJD as there is still no known cause for

6 such, and as recent as two weeks ago scientists

7 in Great Britain are claiming that variant CJD

8 could not be caused by eating BSE-tainted beef.

9 But with regards to BSE itself,

10 four and a half years ago, in offering comments

11 before the agency on the then proposed rule, I

12 called for an all-out effort to eliminate our

13 country\'s only known farm animal TSE: Scrapie.

14 Quote, \"Therefore, let us make an all-out effort

15 to eliminate all scrapie, our only known TSE,

16 from the U.S. Let us start with an immediate

17 destruction of all scrapie flocks and a total

18 indemnification program for the owners. And if

19 TSE elimination is that important, let us

20 complete that phase in 12 months. Let us rid

21 ourselves of that agent all together.

22 \"Australia and New Zealand did

23 it years ago and they have far more sheep than

24 we have in the U.S. Why haven\'t we?\"

25 That was four and a half years

94

1 ago I said that.

2 To that, today I would add that

3 we could certainly import enough scrapie-free

4 sheep from both Australia and New Zealand to aid

5 in the indemnification process at the same time.

6 Secondly, with regard to

7 additional measures, I would like to point out

8 to the agency a growing tendency within various

9 states to allow for nonrendering disposal of

10 animal by-products. Here I refer to composting

11 and landfilling. These methods serve to remove

12 this material from biosecure rendering and at

13 the same time remove it from the traceability

14 offered by the rendering industry in conjunction

15 with the rule.

16 In summary, the current rule as

17 it stands is good, and even more importantly, it

18 is working. There is no scientific reason to

19 change any of the parameters of the rule in any

20 way. No new scientific elements have come to

21 light in the past four years.

22 Furthermore, we do not have BSE

23 in this country. And again, I dare say, we

24 never will. Our cattle are now even more

25 protected than we have ever had them before from

95

1 contracting BSE. Let\'s concentrate on

2 eliminating our TSE of scrapie and eliminate

3 people\'s fears of our cattle succumbing to BSE

4 through scrapie, as unfounded as that may be.

5 Thank you for your time and

6 consideration.

7 DR. LUMPKIN: Thank you,

8 Mr. Kaluzny.

9 Any questions?

10 (No response.)

11 DR. LUMPKIN: Thank you, sir.

12 Our next speaker is Mr. Gerald

13 Smith. He is president of Value Proteins,

14 Incorporated, in Winchester, Virginia.

15 MR. SMITH: Good morning. I\'m

16 Gerald F. Smith, Jr., president of Valley

17 Proteins, Incorporated, Winchester, Virginia.

18 Founded in 1949, Valley

19 Proteins and its subsidiary, Carolina

20 By-Products, is one of the four largest

21 independent recyclers of animal by-products and

22 waste cooking oils in the United States. Our

23 firm operates 22 total facilities, including 14

24 manufacturing plants for recycling animal

25 by-products located along the eastern seaboard

96

1 and southwest region of the United States. We

2 employ over 1300 individuals and operate a fleet

3 of 450 trucks. In the year 2000 we recycled

4 over 3.4 billion pounds of waste materials which

5 was collected from over 65,000 restaurants,

6 supermarkets, farmers and animal and poultry

7 processing facilities located in 17 states.

8 Our organization fully supports

9 FDA Regulation Section 589.2000 enacted in 1997.

10 The U.S. rendering industry took a leadership

11 role in promoting the fire walls around the U.S.

12 cattle industry which resulted from this

13 regulation. In fact, our industry forfeited

14 marketplace for twelve to eighteen percent of

15 our animal protein products when this regulation

16 was enacted.

17 When enacted in 1997, this

18 regulation was based on the best scientific data

19 then available and on the recommendations of the

20 World Health Organization. All exemptions to

21 this regulation are also based on the best

22 scientific data available in 1997. Since 1997,

23 BSE has declined significantly in the United

24 Kingdom, but new cases and increased incidences

25 of BSE have occurred throughout the remainder,

97

1 and most recently in Japan. What has not

2 changed since 1997 is that the U.S. remains

3 BSE-free. These new and increased cases outside

4 the U.K. can be attributed to the export of

5 infected animals from the U.K. and to meat and

6 bone meal which was produced from such infected

7 animals. While it is not scientifically

8 conclusive that the spread of BSE was caused by

9 meat and bone meal derived from infected

10 animals, there certainly has been a strong

11 correlation to the consumption of this product.

12 First, I believe that if BSE

13 were to occur in the United States, it would

14 almost certainly be through the importation of

15 infected animals, animal products or animal

16 by-products. The U.S. government has a duty to

17 increase funding which will allow the FDA, the

18 USDA to protect our country where this disease

19 will almost certainly enter our country: At our

20 ports or borders. With our current concerns

21 over bioterrorism, it is more important than

22 ever that the U.S. be extremely vigilant to make

23 certain that diseases and substances which can

24 harm our human and livestock populations are

25 detected and stopped before they enter our

98

1 country.

2 Second, I believe we have an

3 adequate program of surveillance for BSE, and if

4 this disease were to occur in the United States

5 that it would be detected at the earliest

6 possible time. Our USDA is and has been doing

7 an excellent job of surveillance for BSE. We

8 have tested a greater population of animal

9 brains than that suggested by the World Health

10 Organization for the size of our livestock

11 population. Even more important is that USDA

12 has stepped up surveillance at facilities that

13 receive downer cattle, since this is by far the

14 most likely point for an infected animal to

15 enter our food and/or our food chain.

16 Third, while I believe we have

17 very adequate firewalls to prevent BSE from

18 entering our food and feed chain and prevent

19 amplification of this disease should an infected

20 animal be found in our country, these

21 regulations are only effective if thoroughly

22 enforced. Our company has entered into a

23 voluntary third-party certification because we

24 believe that 100 percent of our facilities must

25 be in compliance with this regulation. I

99

1 support additional funding which would allow FDA

2 each year to inspect an adequate number of dairy

3 farms, cattle feeding establishments, feed

4 compounding facilities and rendering facilities

5 to assure compliance with this regulation. The

6 E.U. and especially the U.K. had adequate

7 regulations. What the Europeans did was fairly

8 to adequately enforce these regulations, and as

9 a result, the European consumers lost faith in

10 both their food industry and their governments.

11 Let us make sure we don\'t follow their example.

12 In conclusion, I fully support

13 the FDA\'s regulation Section 589.2000 which

14 restricts the feeding of ruminant derived

15 by-products to ruminants. I am, however,

16 opposed to reopening this rule, to expanding

17 this rule, or to revoking the exemption for any

18 products which are not exempted by this rule,

19 since I believe any change to this regulation

20 should be based on sound scientific data. Such

21 scientific data has not changed since this rule

22 was enacted in 1997.

23 I believe surveillance for BSE

24 within the United States is adequate but must be

25 a made a priority for funding so that USDA may

100

1 continue to provide our overseas customers with

2 the assurance that U.S. agricultural products

3 are safe and free from BSE.

4 I\'m very concerned about the

5 enforcement of this regulation with our

6 surveillance at our ports and our borders, and I

7 believe that most important \-- excuse me, and I

8 believe that more effort and resources must be

9 provided toward making certain that the

10 firewalls can prevent feeding ruminant proteins

11 to ruminants and which would prevent the entry

12 of BSE into our food chain were BSE to occur

13 must be supported by significantly improved

14 oversight by the FDA.

15 On behalf of our employees, I

16 take this opportunity to thank you for the

17 opportunity to provide this statement today and

18 for the FDA\'s efforts to keep the United States

19 BSE-free.

20 DR. LUMPKIN: Thank you,

21 Mr. Smith.

22 Any questions from members of

23 the panel?

24 (No response.)

25 DR. LUMPKIN: Thank you again.

101

1 The next speaker is Dr. Gary

2 Pearl. He is president and director of

3 technical services with the Fats and Proteins

4 Research Foundation of Bloomington, Illinois.

5 DR. PEARL: Thank you. This

6 opportunity to offer comments to the Food and

7 Drug Administration solicitation of information

8 pertaining to its animal feeding regulation as

9 referenced in the Federal Register October 5,

10 2001, Volume 66, Number 194, is very much

11 appreciated. These comments are being made on

12 behalf of the Fats and Proteins Research

13 Foundation.

14 FPRS is organized to serve the

15 rendering and its associated industries. The

16 rendering function is that of recycling the

17 co-products resulting from food animal

18 production. The rendering and its ancillary

19 support industry has ecologically, economically

20 and via the most biosecure procedure processed

21 the more than 50 billion pounds of inedible

22 animal tissue generated annually into products

23 of value for a variety of useful purposes.

24 Rendering represents the

25 collection of animal raw materials from

102

1 slaughter, from packing, from processing, food

2 preparation and fallen animal sites for

3 transport to process controlled facilities,

4 heated to a temperature higher than that

5 required for sterilization and removes the

6 moisture, a process not afforded by any other

7 permissible alternative. The fat is extracted

8 from the protein and the fat and protein are

9 then used as animal feed ingredients or for

10 other important industrial uses.

11 FPRF was organized in 1962 to

12 provide an institution which will direct and

13 manage a research process that results in an

14 enhanced current usage and the development of

15 new uses for rendered animal products in a

16 biosecure methodology. FPRF is a nonprofit,

17 nonlobbying organization, as defined by Illinois

18 statutes. Approximately 100 industry members

19 voluntarily support and contribute in a

20 cooperative effort to focus research resources

21 to the individual research projects. Over 125

22 projects have been assigned and completed since

23 1994, and all of these projects and their

24 researchers are strongly encouraged to publish

25 the results in peer reviewed journals with

103

1 nearly 90 percent of the projects resulting in

2 published or for public knowledge usage.

3 Though there were 17 specific

4 questions posed in the October 5th, 2001,

5 document. These comments will not address each

6 question directly, but such will be supplied

7 within the written comment period to follow.

8 The 21 CFR 589.2000 regulation

9 has functioned within its objectives to prevent

10 the establishment or the amplification of the

11 infectious agent, the bovine spongiform

12 encephalopathy, to the U.S. cattle population.

13 Thus, in a composite review of the questions,

14 there is little need to duplicate the process

15 initiated 1996 and resulting in the August 1997

16 prohibition of specified animal proteins in

17 ruminant feed. The specifics of that

18 prohibition incorporated the best scientific

19 information available, but it interpreted that

20 information by instilling a degree of cautionary

21 principle as added safety, even while knowing of

22 the BSE-free status in the U.S. as validated by

23 extensive testing.

24 The intensive compliance

25 accompanying the establishment of the rule has

104

1 now been supplemented with the development and

2 implementation of third-party certification

3 programs. Of importance are those of the APPI

4 organization supervised or completed by Cooke

5 and Thurber directed at the rendering industry,

6 and the facility certification institute at the

7 feed manufacturing industry. Both have resulted

8 in validation of facilities that produce a very

9 high percentage of all animal proteins and feed

10 manufacturers producing a significant tonnage of

11 all the mixed feeds. These and other voluntary

12 actions have been taken to ensure compliance

13 with government regulations, while demonstrating

14 an active commitment to the feed and food safety

15 in the animal health, public health sector.

16 Surveillance initiatives and

17 numerous associative regulations initiated in

18 1986 and enhanced throughout this subsequent

19 15-year period have provided no evidence that an

20 enhanced risk for the emergence of BSE has been

21 altered. This foundation has been promoting the

22 research attention to the identified priorities

23 established by the agency and referenced in the

24 August 1997 regulation. Among those were

25 inactivation of the causative agent,

105

1 transmission among inter and intra species,

2 diagnosis with emphasis on preclinical

3 procedures, detection procedures for individual

4 species protein in meat and ingredients and

5 feed, and the epidemiology of the respective

6 TSEs.

7 With the recognition of

8 fragmentary research contributions filling a few

9 voids, in composite most of the outlying

10 priorities still remain. They remain without

11 conclusive answers. These priorities were

12 essentially restated in the summary comments

13 resulting from a USDA/ARS BSE workshop held

14 March 15, 2001. There is not sufficient

15 scientific evidence to alter the regulatory plan

16 that was established, initiated and validated

17 for compliance as outlined in the final rule of

18 August 1997.

19 Additionally, this foundation

20 has, since its inception, retained a focus on

21 the biosecurity principles provided by the

22 rendering procedures. Recent validation that

23 proper time/temperature processing inactivates

24 viral and primary foodborne pathogens \-- and I

25 name in specific Salmonella species, Listeria

106

1 monocytogenesis, Clostridium perfringens and

2 Campylobacteria jejuni \-- in by-products derived

3 from slaughter of animals for food purposes.

4 This assurance is not available for the other

5 alternatives for rendering and certainly becomes

6 increasingly important as we face new

7 biosecurity challenges of today.

8 Animal agriculture has, and now

9 more than ever, depends upon the sanitary,

10 biological secure, ecological and environmental

11 processing and the infrastructure of the

12 rendering industry as a vital synergistic means

13 of utilizing approximately one-half of all

14 livestock and poultry tonnage produced in the

15 U.S. each year.

16 In summary, the 21 CFR 589.2000

17 rule instituted as a firewall regulatory adjunct

18 to a series of precautionary practices is not in

19 need of any extensive modifications or changes

20 until which time science and research findings

21 dictate.

22 Thank you again for this

23 opportunity.

24 DR. LUMPKIN: Thank you,

25 Dr. Pearl.

107

1 Any questions?

2 (No response.)

3 DR. LUMPKIN: Thank you, sir.

4 The final speaker of the

5 morning before we take our lunch break will be

6 Richard Sellers. He is vice president of feed

7 control and nutrition of the American Feed

8 Industry Association in Arlington, Virginia.

9 MR. SELLERS: Thank you

10 Dr. Lumpkin.

11 The American Feed Industry

12 Association is the national feed trade

13 association representing feed manufacturers,

14 ingredient suppliers, equipment manufacturers,

15 pet food manufacturers, animal health

16 manufacturers, and distributors and other

17 suppliers to the feed industry. AFIA members

18 manufacture 75 percent of the primary commercial

19 feed in the United States. Therefore, our

20 members are affected by these regulations, and I

21 present these comments on their behalf. More

22 thorough comments will be provided to the docket

23 prior to November 21st.

24 We appreciate the agency

25 offering this opportunity to review the rule and

108

1 make comments on the current issue, state of

2 science of transmissible spongiform

3 encephalopathies, or TSEs. Only by collecting

4 comments and information can the U.S. have the

5 best prevention program. In fact, AFIA believes

6 the risk of BSE in the United States is near

7 zero and that the vigilance and attention to

8 detail by our government and the industry have

9 resulted in keeping the U.S. BSE-free for over

10 16 years.

11 The three firewalls mentioned

12 by speakers today are very important. And AFIA

13 pledges its continued commitment for compliance

14 to the second firewall, which is the feed rule.

15 We continue to support the FDA\'s hundred percent

16 inspections and believe our continued efforts to

17 educate the industry about compliance with this

18 rule is the best risk reduction effort we can

19 take. In fact, the Facility Certification

20 Institute, which was created by AFIA as an

21 independent third-party inspection system, is

22 very much an educational program designed to

23 certify facilities\' compliance with this rule.

24 AFIA believes the top

25 enforcement priority of the agency should be

109

1 education, followed by aggressive action against

2 any firm or individual knowingly feeding

3 prohibited protein to ruminants or distributing

4 such material for that use.

5 The final rule is basically a

6 labeling and recordkeeping rule, and compliance

7 in the latter area of recordkeeping has been

8 nearly perfect. We believe the labeling

9 compliance is more complicated than the

10 inspection numbers released by the agency. We

11 have met with agency officials to express our

12 concerns about the inspection form and

13 inspection reporting. We fully support CVM\'s

14 effort to fully clarify the compliance issues in

15 its efforts to reduce subjectivity in the

16 inspection form.

17 AFIA has taken an active role

18 in promoting inspection and compliance with the

19 states and seeking funding for them where

20 appropriate. We believe all states should be,

21 and many are, active partners in achieving full

22 compliance with this rule. We urge FDA to fully

23 fund these state inspections where appropriate.

24 With respect to the adequacy of

25 the current rule, AFIA believes the rule is

110

1 adequate and further education and compliance

2 efforts are the most important effective way of

3 reducing risk of BSE coming to the United

4 States. Such a continued, sustained effort

5 would likely be far more effective in reducing

6 risk than any changes to the current rule. We

7 believe the exemptions in the rule are still

8 scientifically justified; however, there needs

9 to be a regular revisiting of the rule to

10 strengthen it if new risks are identified or to

11 remove restrictions if no longer justified by

12 the scientific assessment of risk.

13 AFIA believes that neither

14 dedicated facilities nor vehicles will preclude

15 all risk. We need full compliance with the

16 current rule, which is dependent on continued

17 extensive education and appropriate enforcement

18 actions. AFIA acknowledges that commingling

19 incidents have occurred in the United States.

20 They have been small in number and many are of

21 minor consequence. This low incidence is

22 evidence of the industry\'s commitment to

23 maintaining a BSE-free United States.

24 Regarding licensing of firms to

25 utilize prohibited protein, AFIA believes this

111

1 would detract from the already limited funds to

2 enforce the current rule. Licensing firms would

3 rob the resources for the more important

4 activities of education and compliance.

5 AFIA strongly supports the

6 current cautionary labeling statement and does

7 not believe that pet foods, except salvage pet

8 foods, should be labeled with the statement.

9 This would confuse consumers, as FDA agreed in

10 the 1997 rules preamble. Again, FDA should

11 place its efforts in educating the salvage

12 dealers in gaining compliance using measured

13 enforcement.

14 The recordkeeping provisions in

15 the current rule are required to document

16 compliance with the rule. The long latency

17 period for this disease would require

18 considerable record retention for investigatory

19 purposes. The cost benefit of such a longer

20 time is very high, as little is gained from

21 maintaining records for five to ten years.

22 Again, education and compliance with the rule

23 should be the principal way of reducing risk.

24 The agency\'s rationale for one-year record

25 retention is as valid now as it was in 1997.

112

1 Some might request the agency

2 change the ingredient listing to require

3 species-specific listings. This is a very

4 costly undertaking and would be a reverse step

5 to the 30 years of acceptance and use of

6 collective terms. And I might add as

7 nutritionist, there are no requirements for

8 ingredients; there requirements for nutrients

9 that may be supplied by a number of ingredients.

10 A much easier tasks is to look for the

11 cautionary statement required for products

12 containing restricted use protein products. The

13 statement should be a clear and prominent one,

14 and one that assists the producer in assuring

15 compliance.

16 As indicated earlier, the

17 current cautionary statement is adequate. We

18 believe farmers have a clear understanding of

19 the term \"ruminant.\" AFAI is clearly in favor

20 of a continued education campaign which will

21 likely prove more effective in accomplishing the

22 intended protection than expanding the

23 cautionary statement.

24 AFIA believes the industry

25 definitely needs test methodology that is both

113

1 sensitive and specific in order to ensure

2 compliance and investigate illegal activities.

3 Also we believe false positive

4 tests increase the perception of violations. So

5 we support the continued effort for research in

6 this area. As mentioned earlier, AFIA created

7 the Facility Certification Institute to further

8 educate the industry and certify compliance with

9 this rule. AFIA and FCI believe the agency

10 should demonstrate strong support for this

11 effort. The Facility Certification Institute

12 filed a draft partnership agreement with FDA

13 yesterday to further enhance FCI\'s efforts and

14 to recognize the unique nature of a potential

15 formal relationship of the two organizations.

16 This partnership would allow recognition of FCI

17 certification by FDA and would encourage FDA to

18 shift inspection resources from certified

19 facilities to other compliance and educational

20 efforts designed to reduce the risk of BSE in

21 the United States.

22 AFIA is concerned about the

23 potential for the introduction of BSE into the

24 U.S. via imports. The current inspection

25 process for imports is not adequate, and more

114

1 funds should be directed to preclude the entry

2 of restricted products. There is a real need

3 for the agency to further strengthen this first

4 important firewall.

5 AFI believes, finally, that the

6 agency has been diligent in carrying out its

7 responsibilities commensurate with reducing the

8 risk of BSE being established and amplified in

9 the United States. However, the

10 Administration\'s support lagged during the

11 two-year period of 1999 to 2000 as states were

12 unable to secure complete funding for

13 investigation and the number of inspections were

14 reduced from the first two years. Only after a

15 series of negative media articles appeared

16 earlier in this year did more funds and

17 resources materialize to finish with a new

18 commitment to finish all the inspections. This

19 commitment was made 1997 to finish the

20 inspections within the first two years, but

21 resources appear to have been moved to cover

22 other hot agency topics.

23 The see-saw commitment to the

24 inspection program is unfortunate and

25 unwarranted for an industry which has cooperated

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1 with the agency on an ongoing, constant basis

2 for four years. We need these inspection

3 resources. The American people deserve nothing

4 less than the agency\'s full commitment to

5 preventing this devastating disease from

6 entering the U.S.

7 We pledge our continuing

8 commitment to a goal of 100 percent inspections,

9 100 percent compliance, and assuring the

10 federal/state agencies have the necessary

11 resources to make that happen.

12 I thank you for the opportunity

13 to submit these comments, and I look forward to

14 continuing our education and compliance

15 efforts.

16 DR. LUMPKIN: Thank you,

17 Mr. Sellers.

18 Are any questions?

19 DR. SUNDLOF: Richard, you

20 mentioned that enforcement of those that

21 knowingly violate the regulations. Do you think

22 that continued effort is necessary to maintain

23 education for those that are not fully aware of

24 the regulations in place?

25 MR. SELLERS: I do believe that

116

1 there is a continuing education effort that\'s

2 needed in light of the hundreds of millions of

3 dollars of regulations that we have to deal with

4 from other federal and state agencies. And it\'s

5 important on an ongoing basis to keep this issue

6 in front. We try to do that with our industry,

7 but there are other \-- biosecurity, other

8 pressing things that keep coming out. We sent a

9 number of our videotapes and a number of your

10 compliance guides and our compliance guides when

11 requested. And one of the actions of AFIA is an

12 educational effort to provide those compliance

13 documents actually on a different inspection

14 level, on a higher inspection level than the

15 agency practices.

16 DR. SUNDLOF: Thank you.

17 DR. LUMPKIN: Thank you.

18 One quick announcement before

19 lunch. As many of you are aware, Billy Ray

20 Smith is the Commissioner of Agriculture of the

21 Commonwealth of Kentucky. He is also the

22 occurrence NASDA president. Unfortunately, he

23 could not be with us today but he did send a

24 representative, a Dr. Chris Young, as one of the

25 state representatives. He is standing in the

117

1 back. I introduced the other state

2 representatives earlier, and he joined us at

3 later this morning. So I wanted to make sure I

4 had a chance to introduce him and thank him for

5 being here and representing Commissioner Smith.

6 With that, let us adjourn for

7 lunch. And as per the agenda, we will reconvene

8 at 1:15 in this room.

9 Thanks much.

10 (The luncheon recess was

11 taken.)

12 DR. LUMPKIN: It\'s now 1:15.

13 I\'d like to reopen the afternoon session of this

14 public hearing.

15 I have one announcement. If

16 there\'s is Mr. Ernie Parker in the audience, he

17 needs to call his office. That\'s Ernie Parker.

18 He needs to call his office.

19 The first group of speakers

20 that will be speaking are going to be

21 representing the National Grain and Feed

22 Association. It\'s my understanding there\'s

23 going to be a tag team approach here between

24 1:15 and 1:30. The speakers will be Mr. Joseph

25 Garber from Wenger\'s Feed Mill, Inc., in Rheems,

118

1 Pennsylvania, and Brad Gottula from the Land O\'

2 Lakes Feed in Fort Dodge, Iowa.

3 I think this is Mr. Garber; is

4 that right?

5 MR. GARBER: That\'s right.

6 Good afternoon.

7 The National Grain and Feed

8 Association welcomes this opportunity to provide

9 its thoughts to the Food and Drug

10 Administration\'s current animal feeding

11 regulations designed to keep the United States

12 free of BSE.

13 I am Joe Garber, chairman of

14 the NGFA\'s feed industry committee. I am the

15 nutrition and research coordinator for Wenger\'s

16 Feed Mill, Inc., in Rheems, Pennsylvania. Also

17 presenting a portion of this testimony will be

18 Brad Gottula, chairman of the NGFA Feed Industry

19 Committee\'s Legislative and Regulatory Affairs

20 Subcommittee, as well as chairman of our Animal

21 Protein Transportation Task Force. Mr. Gottula

22 is the director of quality assurance and

23 regulatory compliance for the Land O\' Lakes

24 Farmland Feed, LLC, in Fort Dodge, Iowa.

25 Established in 1986, the NGFA

119

1 is a nonprofit trade association of more than

2 1,000 grain, feed and processing facilities and

3 other grain-related firms. Our members operate

4 more than 5,000 facilities and handle more than

5 two-thirds of U.S. grain and oilseeds. In

6 addition to our oral statement, we also will be

7 submitting a written statement for the official

8 record for this rulemaking.

9 We commend FDA for initiating

10 this rulemaking to review its current BSE

11 prevention regulations. As it does so, we

12 believe it is of paramount importance for FDA to

13 continue to base its decisionmaking on the best

14 available science and prudent risk assessment.

15 The entire world is looking to FDA as a model

16 agency for prudent science-based risk

17 assessment. To deviate from that sound course

18 would undermine the agency\'s moral authority for

19 regulating food and feed safety. Were that to

20 occur, we would likely see the emergence of a

21 hodgepodge of different state laws and

22 regulations to address BSE and an undermining of

23 consumer confidence.

24 We also believe FDA should

25 review its rule from the perspective that not a

120

1 single case of BSE has been detected in the

2 United States. Since 1990 that is viewed as the

3 most extensive of any country in the world, with

4 the exception of Europe, where the BSE agent

5 does exist.

6 This is attributable in large

7 part to an effective and science-based triple

8 firewall strategy implemented by the government

9 that the NGFA strongly supports. Those

10 firewalls consist of import bans, a prohibition

11 on feeding specified mammalian proteins to

12 cattle and other ruminant animals and active

13 surveillance and inspection programs.

14 The NGFA has adopted a BSA

15 prevention policy that pledges our firm

16 commitment to science-based BSE prevention

17 measures. We recognize that science is not

18 static and that the agency and industry have a

19 responsibility to base future decisions on the

20 best available facts that exist.

21 But based on our understanding

22 of the current science related to BSE, the NGFA

23 fully supports the FDA\'s existing regulations

24 and does not believe that the current ban on

25 feeding certain mammalian proteins to ruminant

121

1 animals should be expanded beyond the

2 restrictions now in place. We support the

3 continued use of ruminant-derived protein as a

4 safe, nutritious and wholesome feed ingredient

5 for species for which it is legally approved.

6 With this groundwork laid, we

7 now would like to respond to several of the

8 major questions posed by FDA in its October 5

9 Federal Register notice. We have organized our

10 responses to FDA\'s questions into three broad

11 areas: The scope of the feeding restrictions,

12 enforcement and compliance-related issues, and,

13 as Mr. Gottula will address, operational issues.

14 First concerning the scope of

15 the feeding restrictions. We believe the

16 current FDA rule is adequate to meet the stated

17 objective of preventing the spread through feed

18 of the BSE agent if it were ever to enter the

19 United States.

20 Rather than broadening the

21 rule\'s objectives, we believe the first order of

22 business is to achieve as close to 100 percent

23 compliance with the existing rule, particularly

24 among multi-species feed mills that manufacture

25 ruminant feed and handle prohibited mammalian

122

1 protein. The NGFA does not believe FDA feeding

2 restrictions should be broadened to include

3 other mammalian proteins unless there\'s

4 compelling scientific evidence that the

5 ingredient is a vector of the BSE agent.

6 For the same science-based

7 reasoning, we also do not believe FDA should

8 revoke or change the exclusions for certain

9 products allowed in the current rule, nor should

10 the agency add to the list of mammalian proteins

11 that are restricted from being used in feed for

12 cattle or other ruminants.

13 Second, FDA poses several

14 enforcement and compliance-related questions.

15 The NGFA believes that the existing authorities

16 at both the federal and state level, including

17 the states\' authorities, to issue stop-sale

18 orders, are strong and effective tools to ensure

19 compliance. We believe a visible surveillance

20 presence by FDA and states is more important to

21 encouraging compliance than additional

22 enforcement authorities.

23 Concerning future enforcement

24 activities, the NGFA recommends strongly that if

25 FDA and state partners adopt a more targeted

123

1 inspection and enforcement plan in the future.

2 We believe the central component of such a plan

3 will be a trace-forward approach in which the

4 movement and use of ruminant-prohibited

5 mammalian protein is tracked from the source to

6 subsequent receivers.

7 We recommend this be

8 accomplished through the development of a

9 statistically valid, random inspection program.

10 We believe this should be augmented by states

11 conducting BSE rule compliance inspections as

12 part of their routine feed mill inspections and

13 commend the Association of American Feed Control

14 officials for including that component in its

15 BSE policy statement.

16 In joint meetings with other

17 animal industry, feed and rendering

18 organizations, we believe it is an emerging

19 consensus that a traceable approach makes sense

20 from a risk assessment and resource allocation

21 basis. As part of such an approach, the NGFA

22 recommends that FDA develop an overall strategic

23 plan to guide its future BSE prevention

24 surveillance and inspection efforts.

25 From an inspection standpoint,

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1 we believe FDA\'s first priority should be

2 facilities that manufacture feeds for ruminants

3 and other species and which handle prohibited

4 mammalian protein. Surveillance should also be

5 focused on direct purchasers of prohibited

6 mammalian protein as well as salvage feed or pet

7 food to ensure that the product is being

8 inspected and sold to the appropriate channels.

9 Of secondary importance should

10 be multi-species facilities that utilize

11 prohibited mammalian protein but do not

12 manufacture ruminant feed. As part of the

13 strategic approach we also recommend that FDA

14 and states enhance their coordination of

15 inspections and interpretation of inspection

16 results. In this regard, the recent

17 modification to FDA\'s BSE inspection checklist

18 are a positive step and should lead to improved

19 uniformity of inspection interpretations and

20 results.

21 FDA also asks what role, if

22 any, that public or private certification

23 programs should play. The NGFA strongly

24 supports government-based inspections by FDA and

25 states as providing the integrity and

125

1 impartiality that\'s essential to maintaining

2 consumer confidence. The feed manufacturing

3 sector, the NGFA believes that the decision on

4 whether to participate in a public or private

5 certification program should be an individual

6 company decision based upon the perceived value

7 of such a certification vis-a-vis customer

8 preference and/or market demand.

9 The NGFA believes in the

10 integrity of our industry to truthfully attest

11 to their use or nonuse of prohibited mammalian

12 protein and has worked to facilitate marketplace

13 acceptance of individual company-to-company

14 assurances, including contractual guarantees,

15 company affidavits and other self-certification

16 mechanisms such as those that may be requested

17 by certain customers which are responsive to

18 customer needs. The NGFA\'s feed trade rules and

19 arbitration system as well as the courts provide

20 a time-honored mechanism for enforcing such

21 assurances.

22 Given the breadth and scope of

23 the feed manufacturing industry, the NGFA

24 believes that government actions to mandate or

25 endorse a private sector feed-based

126

1 certification program are neither feasible nor

2 appropriate. While we do not oppose FDA

3 providing oversight of the integrity of private

4 sector feed-based certification programs if they

5 are requested to do so, we caution the agency to

6 secure the necessary assurances so that its role

7 is not misused to create winners or losers in

8 the marketplace. Simply put, we do not believe

9 a feed manufacturer\'s voluntary business

10 decision on whether or not to participate in

11 such a certification scheme should imply that

12 its feed products are any safer or less safe

13 than those who do not.

14 The FDA also asked about the

15 use of analytical tests capable of detecting

16 mammalian protein in ruminant feed. The NGFA

17 believes such tests should be employed by FDA as

18 an enforcement tool only if they have been

19 demonstrated to accurately, repeatedly

20 differentiate between prohibited and

21 non-prohibited mammalian material, including

22 blood, milk and gelatin products, without

23 resulting in false positives. Such tests also

24 should also be compatible with existing

25 FDA-approved equipment clean-out and sequencing

127

1 procedures that have been the hallmark of the

2 medicated feed current for manufacturing

3 practice regulations.

4 To conclude our statement, I\'ll

5 now ask Mr. Gottula to present our thoughts on

6 operation-related questions posed by the FDA.

7 MR. GOTTULA: Thank you.

8 FDA asked several questions

9 concerning whether it should amend its BSE

10 prevention rule to require dedicated facilities

11 or transportation equipment.

12 The NGFA believes strongly that

13 the decision of whether to utilize dedicated

14 facilities to manufacture ruminant feed is a

15 decision that should be made by individual

16 companies based on the practicalities of doing

17 so, given the types of feed they manufacture and

18 customer preferences. In this regard the NGFA,

19 as part of its BSE prevention policy, has

20 recommended as a best management practice that

21 feed mills that manufacture ruminant feeds

22 voluntarily discontinue using prohibited

23 mammalian protein unless they have separate and

24 distinct mixing, handling and storage systems to

25 prevent accidental commingling or cross-

128

1 contamination.

2 It is our understanding that

3 many feed manufacturers have made such a

4 business decision, either because they believed

5 it was the best way for them to comply with the

6 FDA rule or because of preferences from

7 customers or insurance carriers. But for some

8 feed manufacturers, using dedicated plants or

9 equipment may be impractical given the lines of

10 feed they manufacture. For this reason we

11 believe it would be inadvisable and costly for

12 FDA to mandate such a requirement.

13 The NGFA also does not believe

14 FDA should require dedicated transportation

15 equipment for hauling feed or feed ingredients

16 containing prohibited mammalian protein. Doing

17 so would increase delivery costs and disrupt

18 operating efficiency, which, in fact, has

19 occurred under just such a requirement imposed

20 in South Dakota.

21 The NGFA is taking proactive

22 steps to address transportation-related issues

23 associated with the FDA rule. Earlier this year

24 the NGFA established an animal protein

25 transportation task force, which I chair, that

129

1 has drafted a set of best management practices

2 for transporting animal and plant protein in

3 compliance with the FDA rule. The task force

4 consists of representatives from the animal

5 feed, rendering, rail and truck and soy

6 processing industries. The draft best

7 management practices which are under review by

8 the task force identify procedures for using

9 dedicated transportation fleets,

10 customer-assigned equipment and clean procedures

11 if hauling both prohibited and nonprofit

12 mammalian material in the same conveyance. They

13 also cover loading and receiving procedures

14 applicable to the transportation providers,

15 plant and animal protein suppliers and the feed

16 manufacturers. Once finalized later this year,

17 we\'ll be disseminating these procedures widely

18 to companies within the relevant industries as

19 well as through FDA and states and encourage

20 that they be adopted.

21 FDA also posed two questions on

22 labeling. One asks whether the agency should

23 require labels to identify the specific

24 mammalian species from which the protein source

25 was derived and the other asks whether to amend

130

1 the BSE caution statement to identify specific

2 ruminant species that are banned from being fed

3 products containing prohibited mammalian

4 protein.

5 The NGFA strongly opposes

6 changing either of these labeling requirements.

7 We believe that one of the strengths of the

8 current rule is that the labeling and caution

9 statements are well understood by feed

10 manufacturers and feeder customers. Changing

11 them could well create new confusion as well as

12 result in excessive costs for the feed

13 manufacturing industry as a result of the

14 labeling changes with little offsetting benefit.

15 Concerning the identification

16 of species-specific mammalian protein on labels

17 of all feed, the NGFA strongly supports use on

18 feed labels of the \"animal protein products\"

19 collective term as recognized by AAFCO.

20 Collective terms are extremely useful and

21 cost-effective for feed manufacturers because

22 they allow various ingredient sources that have

23 a similar function to be interchanged based upon

24 these cost formulations, without having to

25 change the list of individual ingredients that

131

1 are preprinted on feed bags or tags.

2 The NGFA is unaware of any

3 misuse of the \"animal protein product\"

4 collective term that would justify a change to

5 species-specific ingredient labeling. In terms

6 of ensuring compliance with the BSE prevention

7 rule, it is the presence or absence of the

8 caution statement that feeders and feed

9 manufacturers look for to determine if the feed

10 is prohibited for ruminant species.

11 We also have not seen how such

12 a change would improve the efficiency of the

13 inspection process, as inspectors still would be

14 expected to review records to verify the source

15 of animal or plant proteins being used in feed.

16 If a customer requests such clarification, there

17 are other less costly methods, including written

18 and oral communication, to provide such

19 information.

20 We also believe that a

21 requirement to change the caution statement to

22 identify each type of ruminant is unnecessary

23 and, again, would impose labeling costs on feed

24 manufacturers and their customers. Commercial

25 feeding of sheep, goats, bison, elk and deer are

132

1 relatively niche specialty markets whose feeders

2 fully understand they are feeding ruminant

3 animals.

4 The NGFA appreciates the

5 opportunity to provide its views on this

6 important matter and pledges its continued

7 efforts to achieve our mutual objective of

8 keeping the United States free of BSE.

9 Thank you.

10 DR. LUMPKIN: Thank you to both

11 of you.

12 Are there any questions of

13 either of these gentlemen?

14 (No response.)

15 DR. LUMPKIN: All right. Thank

16 you.

17 The next speaker is Mr. Ben

18 Jones, who is a board member of AAFCO, the

19 Association of American Feed Control Officials.

20 Mr. Jones is with the Texas Feed and Fertilizer

21 Control Service.

22 MR. JONES: Thank you,

23 Dr. Lumpkin.

24 I do currently serve on the

25 board of directors for the Association of

133

1 American Feed Control Officials. On behalf of

2 AAFCO I wish to comment on the current rule, 21

3 Code of Federal Regulations Part 589.2000 to

4 help prevent the establishment and amplification

5 of BSE in the United States cattle herd.

6 AAFCO is an international

7 association with membership consisting largely

8 of state and federal feed control officials

9 responsible for administration of state laws,

10 rules and portions of the U.S. Food and Drug

11 cosmetic act pertaining to the distribution of

12 commercial feed and feed ingredients for

13 livestock, poultry and other animals, including

14 pets.

15 Currently all fifty states,

16 Puerto Rico, Canada, Costa Rica, United States

17 Department of Agriculture and the U.S. Food and

18 Drug Administration are members of AAFCO.

19 AAFCO recognizes that BSE is a

20 serious health threat to ruminant animals in

21 North America. BSE has had devastating effects

22 in Europe on animal and human health as well as

23 the livestock industries and economies of those

24 countries.

25 AAFCO is committed to achieving

134

1 100 percent compliance with the federal rule

2 prohibiting the feeding of certain animal

3 protein products to cattle and other ruminants.

4 State members of our

5 association have conducted approximately eighty

6 percent of the inspections reported by the Food

7 and Drug Administration since the adoption of

8 the above regulations. AAFCO presents the

9 following responses, specifically to the

10 questions listed in the Federal Register:

11 One, what additional

12 enforcement activities, if any, regarding the

13 present rule are needed to provide adequate

14 public health control? We believe that to

15 improve compliance with the rule, more frequent

16 inspection and coordinated reinspection is

17 recommended for the feed manufacturing sector.

18 Inspection and compliance with the current rule

19 should be expanded to include all industries.

20 The agency must expand compliance inspections to

21 the livestock producer level. This could be

22 accomplished in the assistance and coordination

23 of the state animal health officials. Border

24 inspections need to be strengthened to prevent

25 the importation of feeds or feed ingredients not

135

1 complying with the rule. Although it is

2 important to continue to educate, it is time to

3 start increasing enforcement activities. State

4 and federal application of enforcement

5 activities using the AAFCO enforcement

6 guidelines should be considered. Infraction

7 severity and associated regulatory action should

8 be evaluated and applied consistently.

9 2. Is the present rule

10 adequate to meet its intended objectives and are

11 there additional objectives that this rule

12 should now address? We believe that the current

13 rule is a labeling and recordkeeping regulation.

14 The agency should consider adopting good

15 manufacturing practices that could encompass all

16 of potential contaminants, including BSE agents,

17 for all animal feed and feed ingredients. The

18 rule should provide adequate guidance to all

19 involved parties and accommodate other potential

20 contaminants.

21 T. Should the present FDA ban

22 on the use of certain mammalian proteins in

23 ruminant feed be broadened? AAFCO feels this is

24 a science that \-- requires a science-based

25 response. Some of the current exclusions

136

1 deserve further scientific review. There is

2 still considerable debate concerning blood

3 products, plate wastes, tallow and poultry

4 litter.

5 4. Should FDA require

6 dedicated facilities for the production of

7 animal feed containing mammalian protein? The

8 intent and objectives of the rule are better

9 achieved when dedicated facilities or dedicated

10 mixing and conveyance equipment within the

11 facilities are used. When a facility making

12 ruminant feed does not handle prohibited

13 material, the chance of commingling,

14 contamination and accidental mixing or human

15 errors are minimized.

16 The above statement is based on

17 our facility inspection experience. The current

18 rule specifies that materials containing any

19 amount of prohibited mammalian protein must be

20 labeled with the cautionary statement. At this

21 time it is difficult to assure that current

22 flushing and sequencing procedures are adequate

23 to eliminate with 100 percent certainty any

24 amount of the BSE causative agents. We\'re not

25 aware that the agency has established an

137

1 acceptable tolerance for prohibited protein in

2 ruminant feed. The potential for accidental

3 mixing warrants the consideration that ruminant

4 feeds and ingredients intended for ruminant

5 feeds be processed and assembled in a facility

6 or by equipment within a facility dedicated to

7 only handling nonprofit materials for ruminant

8 feed production. This requirement is viewed as

9 a positive step in preventing the occurrence and

10 amplification of BSE in the United States.

11 5. Should the FDA require

12 dedicated transportation of animal feed

13 containing mammalian protein? We believe that

14 requiring dedicated transportation of animal

15 feed containing prohibited mammalian protein is

16 viewed as another positive step in preventing

17 the occurrence and amplification of BSE in the

18 U.S. State feed regulatory agencies have very

19 limited authority over the transportation

20 system. The cleaning of transportation

21 equipment between delivery of various

22 commodities and feed ingredients appears to get

23 limited attention at this time.

24 Feed production facilities do

25 advise sequencing loads of animal feed when

138

1 distributing within reason. In addition, the

2 manufacturers flush their distribution equipment

3 when sequencing is not possible. This could be

4 a prohibitive, resource-intensive activity to

5 observe and determine if distribution equipment

6 was actually being cleaned to eliminate any

7 amount of BSE causative agents. The agency

8 should consider the development of GMPs for the

9 transportation sector to provide regulatory

10 authority, not only for the BSE issue, but also

11 for all potential contaminants in animal feed.

12 At a minimum, the agency should

13 develop and mandate a validated clean method and

14 recordkeeping system for the transportation

15 industry to use. If feed manufacturers use

16 dedicated facilities to manufacture ruminant

17 feed, many of the trucks operated by the feed

18 manufacturers will essentially become dedicated.

19 However, trucks and rail cars used by the

20 commercial transportation industry that haul

21 many ingredients to the manufacturers may not be

22 dedicated. Transportation providers, their

23 equipment and employees may be difficult to

24 find, educate and regulate and will require a

25 coordinated effort with the federal Department

139

1 of Transportation.

2 6. Should FDA require FDA

3 licensing of renderers and other facilities

4 engaged in the production of animal feed

5 containing mammalian proteins? If the intent of

6 a licensing requirement is to utilize the

7 license as an enforcement tool subject to

8 withdrawal of the license for violation of the

9 rule and this additional enforcement tool will

10 be used in a timely and appropriate manner, then

11 we feel this issue may have merit. Without

12 adequate regulatory tools and resources, the

13 agency may not be able to enforce this

14 provision.

15 However, we are not aware of

16 specific examples where this requirement would

17 provide assurance for the prevention and

18 amplification of BSE in the United States.

19 Amendment of the rule to require FDA licensing

20 of renderers and other facilities may not be

21 necessary since most, if not all, firms are

22 licensed by a state of federal agency.

23 Many, if not most, of the

24 states currently require licensing or

25 facility \-- registration of facilities engaged

140

1 in the production of animal feeds. Many states

2 also require licensing or permits for rendering

3 establishments. It would appear that with

4 continued cooperation between FDA and the states

5 that these facilities are identified. However,

6 if the FDA could identify renderers and feed

7 facilities that are not currently licensed and

8 inspected by a governmental agency with the BSE

9 rule for compliance, we would support FDA

10 licensing those firms.

11 7. Should FDA revoke or change

12 any of the current exclusions for certain

13 products allowed in the current rule? This

14 question requires a science-based response. As

15 previously mentioned, blood products, plate

16 wastes, tallow and poultry litter deserve

17 further scientific review.

18 8. Should FDA add to the list

19 of prohibited material in ruminant feed, that

20 being the term poultry litter and other recycled

21 poultry waste products? Again, this question

22 requires a science-based response. The concerns

23 we have of poultry litter is not only the

24 prohibited protein that goes through the

25 digestive tract of the bird, but also the

141

1 unconsumed feed containing prohibited protein

2 that is found in the latter through feed

3 spillage.

4 9. Should FDA remove the

5 exemption for pet foods from labeling with the

6 precautionary statement? The exemption of the

7 caution statement on pet food products can and

8 does lead to confusion and misunderstanding in

9 certain segments of the feed and feeding

10 industry. This statement is made based on

11 several concerns. The first concern was in

12 regard to the use of salvaged pet food products.

13 Broken bag product is being picked up from

14 establishments handling pet products. This

15 product is being further processed and may be

16 used in other animal diets. Although much of

17 this product is making its way into swine feed,

18 on occasion there is some concern that product

19 is being converted for distribution to ruminant

20 animals.

21 The second concern is in regard

22 to the storage of packaged dry pet food at feed

23 manufacturing establishments and on-farm.

24 Animal producers, employees of the feed

25 manufacturing establishments and purchasers of

142

1 animal feed have been educated to recognize

2 protein material on the basis of the labeled

3 caution statement. Since packaged pet food is

4 not required to contain the caution statement

5 established in the rule, there is concern that

6 material from broken bags, leftover materials,

7 or even intact pet food containers are not being

8 recognized as prohibited material and could be

9 incorporated into ruminant feed. In addition,

10 pet food may be a source of imported animal

11 proteins.

12 Preferably the agency should

13 reconsider the current exemption for pet food to

14 be labeled with the caution statement.

15 10. Should FDA extend its

16 present recordkeeping requirements beyond one

17 year? At the current time, the one-year

18 recordkeeping requirement appears to be adequate

19 to do trace-forward and trace-back inspections.

20 However, should there be a reported case of BSE

21 in the United States, the one-year recordkeeping

22 requirement may be inadequate to determine the

23 source of the causative agent.

24 11. Should FDA change its rule

25 to require labeling of protein-containing feed

143

1 to specify what types of mammal was used in the

2 production of the protein? We believe yes,

3 requiring the listing of the type of mammal,

4 along with the specific ingredient, would be of

5 value in preventing the occurrence and

6 amplification of BSE in the United States. This

7 requirement would assist the purchaser to know

8 clearly what ingredients and sources are

9 contained in a feed ingredient or mixed feed

10 product. The current use of the collective

11 \"animal protein products\" also creates unclear

12 situations and inadequate label information for

13 the purchaser.

14 12. Should the required

15 cautionary statement be changed to read \"Do not

16 feed to cattle, sheep, goats, bison, elk or

17 deer?\" We believe it should not read as such,

18 but feel that in order to make the statement

19 more clear and still be comprehensive, we

20 suggest changing the cautionary statement to

21 read, \"Do not feed to cattle, sheep, goats, deer

22 or other ruminants.\" This statement would list

23 the common ruminants and would still leave it

24 open to include other ruminants as well.

25 13. What new information is

144

1 available on potential efficient, accurate

2 analytical methods that may be used in detecting

3 mammalian proteins, and what should the sampling

4 parameters of such a program be? AAFCO has no

5 comment at this time. We think that is a

6 question that will need to be addressed by the

7 scientific community and experts that are

8 currently working in this area.

9 14. Regarding enforcing

10 compliance with the rule, what further

11 authorities, if any, would be desirable in order

12 to enforce the rule adequately? We believe that

13 in general the states have adequate authorities

14 available to enforce the rule. It appears that

15 the agency could use additional enforcement

16 authority and tools. We suggest that the agency

17 may be interested in reviewing the AAFCO

18 enforcement guidelines and craft their

19 enforcement authorities to parallel those

20 stated. Civil penalties and withdrawals from

21 distribution should be considered for adoption

22 at the federal level.

23 15. Regarding helping to

24 increase compliance with the rule, what role, if

25 any, should public or private certification

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1 programs play? AAFCO believes that public

2 agencies and private entities should continue to

3 be a leader in providing education pertaining to

4 the requirements of the rule to their members

5 and the public. We do not believe that public

6 or private certification programs should be

7 utilized to judge compliance of a firm.

8 Adequate state and federal resources are

9 available to make a determination of a firm\'s

10 compliance with the rule.

11 State and federal inspection

12 conclusions should be shared with inspected

13 establishments to demonstrate that the

14 establishment is operating within or outside of

15 compliance with the rule. This will enable the

16 industry the ability to provide the necessary

17 assurances to their customers. Compliance with

18 the rule is mandatory and should not be a

19 component of a marketing program.

20 16. Regarding the import of

21 feed, what should the restrictions on such

22 import be? The restrictions should be country

23 specific and a determination should be made that

24 the country has in place restrictions that are

25 equal to or greater than those in the United

146

1 States.

2 And finally, are there any

3 other additional measures that are necessary to

4 guard against BSE and new variant CJD in the

5 United States? We bode the question that if all

6 state and federal feed regulatory agencies

7 achieved 100 percent compliance from all sectors

8 of the animal feed industry and allied

9 industries and other involved federal agencies

10 achieved their objectives to prevent BSE from

11 occurring in the U.S., would this prevent the

12 likelihood of an occurrence of BSE in this

13 country? We know that TSEs are naturally

14 occurring diseases in many animal species and

15 are occurring in some populations, including our

16 own. We must attempt to minimize the potential

17 impact of an occurrence of BSE. The intent of

18 the current BSE rule is to prevent the spread

19 and amplification of the disease. The FDA must

20 attempt to minimize the potential impact of an

21 occurrence of BSE on the agricultural community

22 and consuming public.

23 The agency and states must have

24 an enforcement rule and provide adequate

25 resources to enforce it. Reaction to mishaps

147

1 that have already occurred must be dealt with;

2 however, proactive approaches must be reviewed

3 and then implemented. Enforcement tools must be

4 in place and used at the federal level that are

5 of significant consequences to the parties

6 involved which are not in compliance with the

7 rule.

8 The agency should encourage and

9 support all state feed control officials to

10 incorporate a BSE inspection component into

11 their routine feed inspection programs. The

12 results of those state inspections should be

13 shared with FDA to be entered into a national

14 database tracking compliance with the BSE rule.

15 On behalf of the Association of

16 American Feed Control Officials, I would thank

17 the Food and Drug Administration for the

18 opportunity to provide these comments.

19 DR. LUMPKIN: Thank you,

20 Mr. Jones.

21 Any questions?

22 (No response.)

23 DR. LUMPKIN: Thanks again.

24 Our next speaker is Randall

25 Gordon. Mr. Gordon is the vice president of

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1 communications and government relations for the

2 National Grain and Feed Association. My

3 understanding is that he\'s been authorized by

4 the Pet Food Institute to speak on their behalf

5 at this time, and he will be doing that and not

6 speaking on behalf of the NGFA.

7 MR. GORDON: Thank you, Dr.

8 Lumpkin.

9 I am speaking today on behalf

10 of the Pet Food Institute, the trade association

11 that represents the manufacturers of 95 percent

12 of the dog and cat food sold in the United

13 States.

14 The Pet Food Institute was

15 unable to have a representative here today

16 because it is conducting its annual board of

17 directors and annual industry meeting in

18 Chicago.

19 The National Grain and Feed

20 Association and Pet Food Institute have

21 developed a strategic alliance to work together

22 on issues of mutual interest between our

23 different industries. It is under that

24 arrangement that I offer the following comments

25 on behalf of the Pet Food Institute in response

149

1 to the agency\'s questions that are under

2 consideration here today.

3 The Pet Food Institute and pet

4 food industry has and continues to support the

5 government\'s efforts to prevent the introduction

6 of BSE into the United States and the safeguards

7 that are currently in place. We agree that the

8 need for a cautionary statement on pet food sold

9 at retail has already been addressed by the

10 agency in its 1997 rule-making and does not need

11 to be considered again.

12 In January 1997, the FDA

13 proposed a cautionary label on pet food sold at

14 the retail level as part of its efforts to

15 prevent the amplification of the BSE

16 disease-causing agent, should it ever be found

17 in the United States. FDA, in its final Federal

18 Register notice later that year, agreed that a

19 label on pet food sold at retail was not needed.

20 The agency noted, quote, \"FDA agrees that the

21 cautionary statement serves no useful purpose on

22 pet food. .These products typically cost

23 substantially more per ton than most complete

24 feeds intended for food-producing animals.

25 Therefore, there is little, if any, risk that

150

1 pet foods\...will be purchased at full price for

2 use in ruminant rations,\" unquote.

3 As was the case in 1997, under

4 a cautionary labeling scheme, pet foods would be

5 the only retail products to carry a

6 precautionary statement on the label. As the

7 research conducted by the Pet Food Institute

8 previously presented to the FDA indicated, such

9 a label would not only have a negative effect on

10 pet food by unnecessarily alarming consumers, it

11 would also have a negative impact on human

12 foods. PFI\'s research has found that 71 percent

13 of consumers would buy something else if they

14 saw such a label on pet food; 68 percent would

15 be very concerned about the safety of the pet

16 food if it carried such a label; and 40 percent

17 of the respondents would be very concerned about

18 consuming beef and lamb because of the label on

19 pet food products sold at retail.

20 Since, as the agency correctly

21 points out, dog and cat food sold at retail is

22 neither designed nor priced to serve as ruminant

23 feed, the necessity for such a label at the

24 retail level is further decreased. Salvage and

25 distressed pet food, as is currently required,

151

1 should continue to carry the label \"Do not feed

2 to cattle or other ruminants,\" and the industry

3 recognizes its responsibility to ensure such

4 materials are handled in compliance with the

5 regulation when used in animal feed.

6 The Pet Food Institute has

7 taken a number of steps to remind its members,

8 other organizations and state government

9 officials of the importance of complying with

10 the salvage and distressed pet food labeling

11 requirements and will continue its efforts to

12 prevent these products from being included in

13 ruminant feed. PFI believes the proper

14 enforcement of the current labeling regulation

15 is the best method to prevent the inclusion of

16 salvage and distressed pet food in ruminant

17 feed.

18 In conclusion, the Pet Food

19 Institute, on behalf of its member companies,

20 believes the agency was correct in 1997 that a

21 cautionary statement on retail pet food products

22 was not necessary. The efforts to prevent BSE

23 from entering the United States have been

24 successful since 1997 in the rule that was

25 issued. A cautionary statement on pet food

152

1 products is not warranted and the current

2 regulation should not be amended.

3 Thank you.

4 DR. LUMPKIN: Thank you.

5 Are there questions?

6 DR. SUNDLOF: Yes.

7 DR. LUMPKIN: Steven.

8 DR. SUNDLOF: Randy, it says

9 here in the PFI statement, numbered steps. Is

10 there official guidance out for that?

11 MR. GORDON: Steve, I am going

12 to have PFI respond to this in writing, if you

13 don\'t mind. They have had some communication

14 with some of the dairy industry and some of the

15 state directors of agriculture on this issue,

16 and I think I can ask them to make that

17 available and respond to that question.

18 DR. SUNDLOFF: The other thing,

19 the research is that a 71 percent of consumers

20 would buy something else if that was on the

21 label. What\'s \"something else\"?

22 MR. GORDON: Again, if I could,

23 I\'ll ask them to respond in writing to that.

24 DR. LUMPKIN: Thank you again.

25 Our next speaker is Brad

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1 Gottula, director of quality assurance, Land O\'

2 Lakes Farmland Feed in Fort Dodge, Iowa. He

3 will be speaking on his own behalf at this

4 point.

5 MR. GOTTULA: Thank you.

6 As was mentioned, I\'m the

7 director of quality assurance and regulatory

8 affairs for Land O\' Lakes Farmland Feed. Our

9 company operates 95 feed manufacturing plants in

10 29 states in the U.S. and in the province of

11 Ontario, Canada. In addition, our grain and

12 feed products are manufactured at over 200

13 locally owned cooperatives in North America.

14 Our company supports the efforts by the FDA and

15 other governmental agencies to prevent BSE from

16 ever becoming a threat in this country. We

17 appreciate the opportunity to respond and give

18 our insight to several of the thought-provoking

19 questions that are the focus of this important

20 hearing.

21 In regards to Question 1, what

22 additional enforcement activities, if any, are

23 needed regarding the present rule to improve

24 public health controls and what suggestions

25 would those be? We do not believe additional

154

1 enforcement tools or measures are needed to

2 enforce 21 CFR 589.2000 that ultimately would

3 provide improved safety and public health. The

4 overall educational efforts that have been

5 ongoing for the last four years need to remain a

6 primary focus in order to make sure all feed

7 manufacturers and animal producers are

8 adequately informed and educated about this

9 important rule.

10 One of the biggest areas of

11 confusion or inadequacy that is existent with

12 this rule is that some feeders, small feed

13 dealerships and non-FDA licensed feed

14 manufacturers to not seem to understand all the

15 rule requirements and exemptions. This

16 ultimately leads to noncompliance issues and

17 misinformation as well as confusion in the

18 marketplace. Continued efforts to educate all

19 entities that are the subject of this rule must

20 be undertaken to improve understanding and

21 compliance. An approach of using targeted

22 inspections of firms who have not consistently

23 proven to be adequately informed and in

24 compliance or of those firms who are actually

25 rendering or using prohibited mammalian proteins

155

1 may be an effective method to improve compliance

2 with the requirements of this rule.

3 In regards to Question 3,

4 Should the present FDA ban on the use of certain

5 mammalian proteins in ruminant feed be

6 broadened? The present rule that bans the use

7 of certain mammalian proteins in ruminant feed

8 should only be broadened if compelling

9 scientific evidence supports the fact that an

10 ingredient or product may be a carrier of the

11 BSE agent. Banning products based on anything

12 other than scientific evidence leaves the feed

13 industry and our customers prey to the emotion

14 and speculation that ultimately damages the

15 credibility of our nation\'s animal feed and food

16 supply. Suggestions to ban approved feed

17 ingredients such as blood products, gelatin and

18 milk products should be halted as scientific

19 evidence from extensive studies done in Europe

20 in the past by the World Health Organization as

21 recently as mid to late \'90s have proven that

22 blood products do not carry the BSE agent. Any

23 revocation of an exemption or excluded product

24 currently allowed under 21 CFR 589.2000 should

25 and must be based on sound science. If

156

1 compelling scientific evidence does not prove a

2 product is a carrier of the BSE agent, it should

3 be allowed or continued to be allowed as an

4 approved feed ingredient for specific species of

5 animals.

6 Question 4, Should the FDA

7 require dedicated facilities for the production

8 of animal feed containing mammalian protein to

9 decrease as much as possible the possibility of

10 commingling during production? Many feed

11 companies, including Land O\' Lakes, Farmland and

12 Purina Mills have voluntarily made this decision

13 either soon after the publication of the rule in

14 1997 or more recently. The voluntary stance

15 many companies have adopted and Land O\' Lakes

16 Farmland Feed supports regarding not

17 manufacturing ruminant feeds in facilities that

18 utilize prohibited mammalian proteins or to

19 simply not utilize prohibited mammalian proteins

20 in their feed mills is working, and there is

21 little added benefit foreseen in making this a

22 mandatory requirement with the absence of BSE in

23 this country.

24 Regarding Question 5, Should

25 FDA require dedicated transportation of animal

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1 feed containing mammalian protein to decrease as

2 much as possible the possibility of commingling?

3 From an efficiency standpoint, this will

4 increase delivery costs and the operational

5 challenges to effectively transport feed and

6 feed ingredients.

7 The recent enactment in South

8 Dakota of specific transportation and handing

9 regulations for delivery vehicles transporting

10 ruminant feeds and feeds that may contain

11 mammalian proteins will increase the costs for

12 feed manufacturers, dealers and customers

13 because it is removing transportation

14 efficiencies that feed manufacturers have

15 utilized in a safe and efficient manner for many

16 years.

17 Today in South Dakota two

18 delivery vehicles may now be required to deliver

19 a feed shipment depending on the type of feed

20 that, in the past, was usually taken care of by

21 one vehicle. At \$1.40 per gallon for fuel for

22 delivery vehicles that typically average six to

23 seven miles per gallon, this is very expensive

24 for feed manufacturers and haulers, and these

25 costs will be passed on to customers.

158

1 In the case of prohibited

2 mammalian protein ingredients that are delivered

3 to feed manufacturing sites, we believe there

4 may be some inherent benefit in having dedicated

5 trailers and rail cars for these products, as

6 this will likely reduce cross-contamination

7 issues. However, additional costs will be

8 incurred and likely passed on to manufacturers,

9 dealers and customers.

10 Regards to Question 11, Should

11 FDA change its rule requiring labeling of

12 protein-containing feed to specify what types of

13 mammal was used in the production of the

14 protein? AAFCO has utilized and the FDA has

15 endorsed the use of the collective feed term

16 concept in 35 states since the early 1970s. The

17 concept is based on the sound nutritional

18 principle that animals do not require any

19 specific feed ingredient but need nutrients that

20 can be provided by a wide range of ingredients.

21 The benefits of these terms are many, but

22 primarily result in lower cost to the

23 producer/customer without any sacrifice in

24 safety or nutrition. No other labeling concept

25 has been nearly so successful in the feed

159

1 industry.

2 Of the seven collective terms

3 acting legally as definitions on feed labels,

4 the one with the most concern is \"animal protein

5 products.\" In 1998 AAFCO asterisked all the

6 feed definitions within this term which are

7 prohibited/restricted in ruminant feeds as per

8 21 CFR 289.2000. The feed industry strongly

9 supported this effort.

10 FDA requires firms to place the

11 caution statement, \"Do not feed to cattle or

12 other ruminants\" on any label or label

13 containing or likely to contain any substances

14 prohibited in ruminant feed. This statement is

15 the sole indicator that if feed is likely to

16 contain a restricted-use protein product from

17 the list of asterisked products in the AAFCO and

18 protein product collective term. If a firm does

19 not use the cautionary statement, it indicates

20 that the feed does not contain restricted food

21 products.

22 Some regulatory officials

23 believe that doing away with the \"animal protein

24 products\" collective term would simplify

25 regulatory obligations. This view is not

160

1 necessarily correct, as verification of the

2 ingredients actually used in a feed formula

3 requires review of formula records, regardless

4 of whether a collective term is used. For

5 example, if a firm were to use the term \"meat

6 and bone meal\" only on a label without the

7 collective term, verification would still be

8 required in order to document the actual

9 ingredient used is indeed the one on the label.

10 If AAFCO or FDA were to change

11 the protein ingredient names to require species

12 names, as is already voluntarily allowed, the

13 names can be porcine or pork meat and bone meal

14 and bovine or beef meat and bone meal. If a

15 firm chooses to use one of these names on a

16 label with or without the cautionary statement,

17 investigators would still be required to examine

18 formulas and ingredient records to verify if, in

19 fact, the correct product and ingredient name

20 were used. Any changes made to collective term

21 or ingredient listings on feed labels must be

22 based on a sound understanding that the changes

23 will result in better compliance, better

24 regulation or better prevention of BSE.

25 Moreover, a review of the inspection data

161

1 collected by FDA should clearly reveal that

2 either there is widespread abuse of the term or

3 serious misbranding to justify changing these

4 ingredient names. That justification does not

5 exist at this time.

6 Regulatory changes regarding

7 use of collective feed labeling terms will

8 result in substantial costs to change feed

9 labels, and feed manufacturers and regulatory

10 agencies must justify the costs for any benefits

11 derived. Regulatory changes regarding changes

12 in accepted feed labeling practices moves our

13 industry further from having uniform feed

14 labeling guidelines across state lines and

15 further hampers effective and efficient business

16 practices, as mentioned earlier with the example

17 in South Dakota and the additional regulations

18 they have not implemented regarding feed

19 labeling, handling and transportation. As the

20 U.S. does not have BSE, it is difficult to

21 justify this major change to feed labeling

22 regulations.

23 In regards to Question 12, In

24 order to make the statement clearer, should the

25 required cautionary statement on the label of

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1 products that contain protein derived from

2 mammalian tissues and that are intended for use

3 in animal feed be changed to read, \"Do not feed

4 to cattle, sheep, goats, bison, elk or deer.\"?

5 We do not believe changes are needed in the

6 caution statement, as the statement is adequate

7 to communicate the intended information,

8 provided people using the product look for the

9 statement and read and follow the product

10 label. A change in the caution statement

11 wording would be quite costly to the feed

12 industry, and would provide little, if any,

13 added benefit to the feed customer and consumer

14 who ultimately must pay for these changes.

15 In regards to Question 15,

16 regarding helping to increase compliance with

17 the rule, What role, if any, should public or

18 private certification programs play?

19 Certification programs can exist in a variety of

20 forms. Affidavits and self-certification forms

21 are and should be widely accepted, as many

22 companies are in compliance with this rule and

23 have excellent documentation, and their quality

24 assurance and regulatory programs that prove

25 this. FDA has recently updated their BSE

163

1 inspection form to include an inspection finding

2 summary section in which, when the inspection

3 finding or inspection report is eventually

4 shared with the firm that\'s been inspected,

5 compliance or noncompliance with the BSE rule is

6 documented. This should be ample proof to any

7 feed customer or livestock buyer that the firm

8 in question is in compliance with 21 CFR

9 589.2000. Fee-based third-party certification

10 programs may be of interest to some companies,

11 but our view is that FDA must be cautious in

12 whether or not it endorses such certification

13 programs as this may open the door to unfair

14 competition in the marketplace by companies who

15 would possibly leverage livestock buyers and

16 food companies to only purchase animals fed by

17 third-party certified feed manufacturers. Our

18 firm belief is that state and federal BSE

19 inspection programs are working and should

20 continue to be the compliance indicator for the

21 regulated industry. Funding should continue to

22 be directed toward this end.

23 Land O\' Lakes Farmland Feed

24 appreciates the opportunity to share our views

25 on this important feed regulation. We have

164

1 worked diligently to inform our employees and

2 customers of this rule\'s requirements and pledge

3 to continue to do all we can to prevent BSE from

4 threatening our nation\'s feed and food supply.

5 We would like to commend the FDA for its

6 scientific view of this important issue and urge

7 that they continue to foster open dialogue and

8 reason regarding this rule as it is evaluated as

9 to its effectiveness.

10 DR. LUMPKIN: Thank you.

11 Mr. Gottula. Any other questions?

12 (No response.)

13 DR. LUMPKIN: Thank you, sir.

14 I\'d like to ask now Mr. Mark

15 Hohnbaum to come to the podium. Mr. Hohnbaum is

16 with H.J. Baker & Brother, Inc., in Little Rock,

17 Arkansas.

18 MR. HOHNBAUM: My name is Mark

19 Hohnbaum, and I am the representative of H.J.

20 Baker & Brother, Inc. H.J. Baker & Brother has

21 served the feed food industries for 151 years.

22 One of our largest businesses is animal and

23 marine protein formulate. We have four domestic

24 plants for this application.

25 As one of the largest consumers

165

1 of rendered animal proteins in the United

2 States, we have a unique perspective on the

3 rendering industry. We purchase material that

4 runs the gamut from fish to fowl and beef to

5 pork. Our suppliers range in scale from the

6 fully integrated multi-nationals to the mid-size

7 independent renderers and finally down to the

8 tiny one-plant operators.

9 From this view some things are

10 apparent that may not be obvious from the

11 outside looking in.

12 Education about what our

13 industry really is started more than thirty

14 years ago with an isolated few. It has

15 accelerated through the past five years to a

16 point where all rendering industry employees now

17 know we are in the food business. This

18 understanding lends a certain gravity to all

19 activities undertaken.

20 In the late 1980s, when the

21 first reports of a causal link between meat and

22 bone meal from scrapie-infected sheep being fed

23 to cattle was postulated as the source of BSE,

24 our company, with the majority of U.S. rendering

25 and feed industry companies, voluntarily removed

166

1 this risk material from our plants. We see

2 amazing variety in this industry. But we see

3 total unanimity in the knowledge that total

4 compliance and complete adherence to feed ban

5 rule is vital to public health and our

6 industry\'s future.

7 This is a responsive and

8 responsible industry manned by smart people. We

9 not only see the fruits of our labor but sit

10 down at mealtime with our families and consume

11 its ultimate products. We value food safety.

12 We also value valid science.

13 The best science today suggests that TSEs are a

14 complex and vexing category of diseases.

15 However, working from today\'s generally accepted

16 postulates, the transmission agent is prion.

17 This prion from the sheep with scrapie infected

18 cattle in the U.S. and started the BSE epidemic

19 that they are fighting today. Many factors that

20 were present in the U.K. beef food industry in

21 the early 1980s have been and are dramatically

22 different here in the U.S. High versus low

23 sheep/cattle ratio, low versus high temperature

24 rendering systems, high versus low cattle herd

25 age, and high versus low \-- now no \--

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1 ruminant-derived protein in ruminant feed

2 rations. These obvious differences could go a

3 long way toward explaining why the disease

4 didn\'t spontaneously generate here.

5 When coupled with the USDA\'s

6 ban on imported cattle from suspect countries

7 and subsequent bans on meat and bone meal from

8 these same countries, then our risk at that time

9 was very, very low. Add to these factors

10 FDA-CVM\'s well conceived and comprehensive rule

11 based on the best science available, coupled

12 with strict enforcement, and it has reduced the

13 risk to the limits of detectability.

14 Safeguards are in place and

15 working. FDA-CVM\'s mandate to protect

16 human/animal health has been well served by this

17 regulation. Reopening the rule would increase

18 public anxiety, not public safety. Let the

19 regulation stand. Do not reopen the rule.

20 Thank you very much.

21 DR. LUMPKIN: Thank you, sir.

22 Any questions.

23 (No response.)

24 DR. LUMPKIN: Thank you again.

25 I\'d like to now call on

168

1 Mr. Michael Malecha, who is president of AG

2 Innovations in Madison, Wisconsin.

3 MR. MALECHA: Thank you,

4 Dr. Lumpkin. I\'m Mike Malecha, and I am

5 president of AG Innovations in Madison,

6 Wisconsin.

7 As consultants to the food,

8 feed and industrial agricultural industry, our

9 main focus is to work with client companies to

10 effectively manage their co-products to greater

11 value, both economically and environmentally.

12 Maintaining feed and food safety is paramount in

13 the fulfillment of our responsibilities.

14 As an active member of the feed

15 industry, I currently serve on the board of

16 directors, chair the feed trade rule

17 subcommittee and serve on the feed and industry

18 committee of the National Grain and Feed

19 Association. I recently served as a member of

20 the liquid feed committee of the AFIA. During

21 my 26 years in the food and feed industry, I

22 most recently spent eleven years at Kraft foods

23 North America as manager of by-products and feed

24 ingredients, and prior to that for nearly ten

25 years at Ralston Purina Company managing feed

169

1 ingredient purchasing in their pet food and

2 grain divisions.

3 To start out, it\'s important to

4 reiterate: There\'s not been a single case of

5 BSE found in the United States today. Due to

6 active surveillance by the FDA and USDA and

7 strong industry support by feed manufacturers,

8 livestock producers, meat processors,

9 transportation industry, food manufacturers and

10 purveyors, veterinarians and trade groups, the

11 science-based regulations currently in force

12 have facilitated the goal of keeping BSE from

13 entering our country. The FDA should be

14 commended for their leadership in preventing

15 BSE, and for being the linchpin in the

16 protection of our food and feed supply. The

17 establishment and enforcement of the three

18 firewalls has provided a sound strategy in that

19 effort.

20 We strongly believe that the

21 FDA must continue to base its position on sound

22 science as we move forward. As new scientific

23 information is confirmed, the strategy should be

24 adjusted to accommodate it. It is vitally

25 important that FDA maintains its high standards

170

1 and its reputation as the lead agency in food

2 safety in the United States and in the entire

3 world. Because of that leadership and the

4 support of the entire food industry, the public

5 will continue to enjoy the safest food supply

6 available. To continue in those efforts I

7 recommend that the FDA should maintain the

8 program of direct inspection by providing the

9 necessary resources and enlisting the support of

10 the state feed control agencies to inspect meat

11 facilities and transportation concerns. The

12 regulatory task can be accomplished. It is our

13 view that affidavits of compliance and bona fide

14 third-party inspections as APPI has undertaken

15 are effective measures as long as there\'s

16 definite periodic inspection by the FDA or their

17 state counterparts. To endorse or recommend

18 certification by not-so-independent arms or

19 organizations as a means to reduce FDA

20 inspections would undermine the confidence and

21 support of the food industry and the public at

22 large and would damage the reputation of the FDA

23 that it currently enjoys. These latter

24 certifications, while certainly providing

25 augmentation to company best practices, are

171

1 viewed by much of the food industry as not

2 independent enough and as possibly

3 anti-competitive due to their nature when foods

4 produced from these products may be certified as

5 beneficial and superior. We stand behind the

6 FDA and the BSE prevention effort. A strong

7 science-based FDA adds credibility to the food

8 and feed industry in the global economy as well.

9 To improve compliance with the

10 rule we\'d recommend that the FDA and state

11 agencies forge a strong inspection and

12 compliance program that is driven by a tracking

13 system from the initial source to an ultimate

14 user. By using a trace-forward approach, a

15 targeted inspection program can be implemented

16 in an effective and efficient manner to best

17 deliver the necessary feed safety. It is

18 vitally important that adequate funding be

19 provided by congress to carry out the strategies

20 to meet full compliance with the rule.

21 Regarding the present rule and

22 its objective, we believe the current rule is

23 satisfactory as written.

24 The issue of dedicated

25 facilities should be left to the individual

172

1 companies to decide based on their ability to

2 manage the process. As a recommended best

3 practice, separate facilities or fully separate

4 systems would be preferred; but the ultimate

5 decision should left to the individual business.

6 To require separate facilities would be

7 anti-competitive and could be financially

8 detrimental to some concerns.

9 The transportation method

10 should be left up to the shipper and receiver to

11 decide, provided best management practices are

12 employed to comply with the rule. To restrict

13 shipment to dedicated conveyances would be

14 extremely costly and lead to unnecessary

15 overcapacity and/or significant delays in

16 service.

17 We do not believe that the FDA

18 should change or revoke any of the exclusions to

19 the current rule, nor should the agency add to

20 the list of prohibited materials unless there is

21 compelling science-based evidence to do so.

22 Unless new scientific evidence is available, the

23 feeding of plate waste, which includes

24 previously USDA-inspected cooked meats, should

25 continue. Reverting that product to landfill or

173

1 other destruction would add to groundwater

2 issues or things that are governed by EPA and

3 increase cost to the restaurant and food

4 industry.

5 Unless science supports the

6 addition of dairy or gelatin to the prohibited

7 list, we do not support that for convenience, as

8 it would send a negative message to consumers

9 who regularly purchase those foods for their own

10 use.

11 We would recommend that FDA

12 continue to exempt pet foods from labeling in

13 the precautionary statement. Salvage pet food

14 should be properly noted with a precautionary

15 statement on the shipping documents, however.

16 Present use of mammalian feeds where packaging

17 is destroyed in the process, and having it on

18 the label would add no value.

19 I want to thank the FDA today

20 for scheduling this hearing and for the

21 opportunity to provide these remarks.

22 DR. LUMPKIN: Thank you very

23 much.

24 Are there any questions of

25 Mr. Malecha?

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1 I have one question, and

2 perhaps it\'s a bit rhetorical. I thought it was

3 interesting, you made the point that you had a

4 concern that if certain products were now said

5 to be unable to be used in animal feed, that

6 that might have a negative effect on consumers

7 because they would misinterpret this.

8 MR. MALECHA: Yes, sir.

9 DR. LUMPKIN: Is there any

10 other evidence that that happened when the

11 original ban went into effect and we said you

12 can\'t feed beef to cattle? Did that have a

13 negative effect on the consumers\' view that beef

14 was safe in this country?

15 MR. MALECHA: I\'m not sure we

16 saw a measured response to that very

17 specifically. What happened in the biotech area

18 in relation to \-- well, not only organic but any

19 biotech concerns in products and the

20 relationship is pretty close, especially as

21 we\'ve seen in the press and everything else.

22 Bringing other diseases and linking them with

23 BSE, we see that that potential does exist.

24 Also it\'s subject, obviously,

25 to mismarketing, and you\'re never totally safe

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1 in that process.

2 DR. LUMPKIN: Fair enough.

3 Thank you, sir.

4 Our last speaker before the

5 afternoon break is Steven Roach with the Food

6 Animal Concerns Trust out of Chicago, Illinois.

7 MR. ROACH: Yes. I would like

8 to thank the FDA for providing us the

9 opportunity to present these comments.

10 Food Animal Concerns Trust is a

11 nonprofit organization that advocates better

12 farming practices to improve the safety of meat,

13 milk and eggs. FACT was at the table when the

14 federal strategy to keep U.S. cattle free from

15 bovine spongiform encephalopathy, BSE, was

16 fashioned several years ago, and FACT worked on

17 the drafting of the FDA rule to prohibit certain

18 types of mammalian protein from ruminant feed,

19 which we are reexamining today. FACT\'s position

20 on BSE is based on an awareness of the real

21 risks of transmissible spongiform

22 encephalopathies, TSEs, to human and animal

23 health, combined with an acute sensitivity to

24 the current scientific uncertainties on how this

25 class of diseases is transmitted both within and

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1 between species.

2 FDA has requested public

3 comments on several aspects of the existing role

4 to limit the spread of BSE through the

5 regulation of animal feed. FACT commends the

6 FDA for the work they have done so far in

7 creating the original role and enforcing its

8 provisions, but we feel that the time is right

9 for a re-evaluation of the regulation.

10 Since 1997 we have seen the

11 disease spread throughout Europe, and it has now

12 been found in Asia. The profile of the disease

13 in Europe indicates how easily the disease can

14 spread when controls on feeding are not

15 stringently enforced. So the evidence in Europe

16 is that they did have effective rules and

17 regulations, but that enforcement of the

18 regulations failed, and that\'s why they\'ve been

19 getting more new cases. So what it looked like

20 in Europe happened was we had the disease got to

21 a country, and then the people started enforcing

22 the regulations, and we fear there\'s a risk of

23 that scenario happening here as well. The

24 unexpected appearance of BSE in Japan suggests

25 that other countries outside of Europe may have

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1 undetected cases, and there is a real risk that

2 feedstuffs containing the disease or the

3 affected material will be imported into the U.S.

4 It is important to note that we did not have

5 restrictions on importing feed from Japan during

6 the period when the disease was present but

7 undetected. And I wasn\'t able to get the exact

8 figures on it, but I think in the last year we

9 imported 10,000 metric tons of feed from Japan.

10 So\'s not a lot of feed, but it is some. And

11 it\'s not clear how much of that might have had

12 meat and bone meal in it.

13 Because BSE is currently

14 developing into a worldwide problem, spreading

15 from its appearance in a single nation, the

16 United Kingdom, FACT calls on the FDA to broaden

17 the scope of the FDA ban and to more rigorously

18 enforce the current provisions.

19 I will now discuss the

20 questions on which the FDA has requested

21 comments.

22 For Question No. 1, FDA needs

23 to respond quickly to operations that are out of

24 compliance with the rule. In a recent report

25 provided by the FDA\'s Center for Veterinary

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1 Medicine, CVM, over 500 businesses were found to

2 be out of compliance. Almost 400 of these firms

3 that were out of compliance handled both

4 ruminant and nonruminant feed. Perhaps even

5 more disturbing is the fact ten firms that

6 handle both ruminant and non-ruminant feeds met

7 none of the requirements of the rule and have

8 not been reinspected since the end of 1998. We

9 accept that the compliance inspection process is

10 an arduous task, but here we have a clear case

11 of rule violations with no follow-up in over two

12 years. According to the rule, these businesses

13 are clearly in violation of the Act and are

14 marketing the illegally adulterated animal feed.

15 If after a prompt follow-up inspection the

16 business is still not in compliance with the

17 law, the FDA should use its authority to

18 confiscate and condemn any illegally adulterated

19 feed. This would obviously include any feed

20 intended for sale as ruminant feed by the

21 out-of-compliance entity.

22 Okay. For Question No. 2.

23 FACT believes that the current rule is too

24 narrow in its scope and focus. The aim of the

25 rule should be expanded to reduce potential

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1 amplification of all TSEs and not focus so

2 narrowly on BSE. The first way in which it

3 should be modified is that there are too many

4 exclusions on the types of protein that are

5 regulated.

6 The second area where the rule

7 fails is that it does not sufficiently address

8 the potential for the transmission across

9 species barriers. These two failures will be

10 addressed below in response to Question 3.

11 Okay. So Question 3. TSEs

12 have been found to affect humans, goats, sheep,

13 mink, deer, elk, cattle, domestic and wild cats,

14 zoo ruminants and zoo primates. Experimentally,

15 TSEs have been transmitted to mice, and it has

16 also has been transmitted experiment to swine.

17 The transmissible agent for all TSEs is believed

18 to be an altered form of naturally occurring

19 protein \-- prion \-- that builds up in central

20 nervous tissue, leading to neurological disorder

21 and death.

22 In addition to being found in

23 the central nervous system, the transmissible

24 agent is also found in the lymphatic tissue,

25 intestines and blood. For each of the known

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1 TSEs, as FACT understands it, there is still

2 uncertainty about how the infectious agent is

3 transmitted and about how the disease develops

4 during incubation.

5 When interspecies transmission

6 is included, the picture becomes even murkier.

7 In the case of BSE, there is evidence of

8 transfer between cattle and many other species,

9 including felines, ruminants and humans. And in

10 these cases, this is natural transfer through

11 the world and not an experimental route. While

12 it is clear that there exit barriers to the

13 transmissions of TSEs between species, the

14 nature of these barriers is little understood.

15 Therefore, FACT urges the FDA

16 to limit the exclusion on mammalian proteins

17 allowed for feeding to ruminants to milk and

18 milk products and to products made exclusively

19 of horse and/or equine protein. The current

20 exclusion of blood products is unacceptable,

21 given the clear evidence of infectivity in

22 blood.

23 Similarly, there is no

24 justifiable reason to exclude food offered for

25 human consumption, such as plate waste. This is

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1 particularly important given the potential for

2 unspecified material of foreign origin in plate

3 waste such as was implicated in the outbreak of

4 foot-and-mouth disease in the United Kingdom.

5 Because of the continuing

6 evidence regarding the potential to transfer

7 TSEs between species, FACT recommends that the

8 FDA review whether or not restrictions should be

9 replaced on any animals with neurologic

10 disorders as feed for any livestock, including

11 poultry, equines and swine. The use of

12 materials from bovine central nervous system

13 should be banned, along with the use of bovine

14 materials from any countries with a high risk

15 for BSE for any animal feeding purposes.

16 In relation to Questions 4 and

17 5 on dedicated facilities or dedicated

18 transportation, FACT believes that dedicated

19 transportation and facilities are important,

20 given the very difficult task it would be to

21 enforce compliance or have inspection, on a

22 daily basis, of facilities. So you may come

23 once a year and look at the facilities and they

24 clean out very well; but cleaning out on a

25 day-to-day basis is going to be something that

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1 there will always be \-- hides enough to cut

2 corners on that. So one way to get around that

3 strong incentive to cut corners on clean-out is

4 to just have dedicated facilities.

5 Okay. For Question 6. Where

6 FDA does not currently license feed preparation,

7 licensing other establishments would be an

8 excellent tool for increasing compliance with

9 the rule. If it is not feasible to license all

10 facilities, a subset of facilities could be

11 licensed. Facilities that produce feed for

12 ruminants could be licensed, or facilities that

13 handle both ruminant and non-ruminant feeds

14 could be licensed. Licensing would need to be

15 combined with enforcement to make it an

16 effective tool. Licensing combined with

17 monitoring using analytical methods that

18 distinguish between prohibited and

19 non-prohibited materials could provide a much

20 higher level of compliance than our current

21 system with its less than annual checks.

22 I\'ll skip down to Question 10.

23 Should FDA extend its present recordkeeping?

24 Records should be kept for a minimum of five

25 years. FACT pushed for this provision when the

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1 rule was first considered, and FACT still

2 believes it is an important provision. Because

3 the incubation period for BSE is four to five

4 years, FACT urges FDA to require that records be

5 kept for a minimum five years, providing the

6 information necessary to trace the source of

7 infection in case of an outbreak.

8 I am going to skip to Question

9 14. Regarding enforcing compliance with the

10 rule, what further authorities, if any, would be

11 desirable? FDA should use its existing

12 authority to condemn adulterated product as

13 defined in the rule in the case of repeated

14 consistent noncompliance. FDA should seek to

15 extend its authority to investigate potential

16 violations that occur where feed is mixed

17 on-farm. So FACT is concerned that there may be

18 mixing of ruminant proteins back on-farm that\'s

19 not inspected or monitored in any way

20 whatsoever. So we think there needs to be some

21 system to look at what\'s actually occurring

22 on-farm.

23 Regarding public and private

24 certification programs, our position basically

25 is that certification programs are fine as

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1 educational tools and to help businesses develop

2 their internal control systems, but they should

3 not be used by the FDA as a justification for

4 lessening its own compliance monitoring program.

5 On the importers of feed, FACT

6 urges the FDA to follow the official

7 International Des Epizooties standards and

8 conduct risk assessments on individual

9 countries. Given the risk of importing BSE

10 infected feed into the U.S., imported feed

11 containing animal proteins should not be used in

12 feeding ruminants unless the country of origin

13 has demonstrated effective rules for the

14 segregation and labeling of feed that are

15 equivalent to U.S. rules. So at this point,

16 since we don\'t have those risk assessments done,

17 I think we should be real cautious about any

18 imported feed for ruminants in the U.S. That\'s

19 a job that needs to be done.

20 Okay. Are there any other

21 additional measures necessary? FACT believes

22 that much more work needs to be carried out on

23 basic research on BSE and other TSEs. One area

24 that is absolutely essential is the development

25 of a diagnostic test that can be used on live

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1 animals. More research also needs to be done on

2 the nature of the species barriers between the

3 different TSEs. Right now we don\'t see any

4 evidence of there being a risk for a swine, but

5 I think that\'s something that we need to

6 constantly, in our minds, be alert for. We have

7 to remember that before BSE we didn\'t think

8 there was risk in bovines. Things change, so we

9 need to be very alert and careful.

10 In summary, FACT urges FDA to

11 continue its current efforts to control the

12 potential spread and amplification of BSE. In

13 addition, FACT calls on FDA to strengthen its

14 efforts by broadening the range of prohibited

15 products to include all ruminant proteins and by

16 taking further precautions with the most at-risk

17 materials, such as proteins from animals with

18 neurological disorders.

19 In the area of monitoring of

20 compliance, FDA needs to step up reinspection of

21 noncompliant firms and, if necessary, to use its

22 authority to condemn feed that is adulterated by

23 definition of the rule.

24 And again, I\'d like to thank

25 FDA for providing us the opportunity to present

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1 these comments.

2 DR. LUMPKIN: Thank you, Mr.

3 Roach.

4 Are there any questions from

5 the panel?

6 I wasn\'t sure if you said this.

7 I apologize for having missed it. But does FACT

8 have any views on the poultry litter issue? You

9 talked about some of the exclusions. I wasn\'t

10 sure.

11 MR. ROACH: Yes, we do have a

12 concern there. I mean, our organization does

13 not believe that feeding litter is a good idea

14 for other issues. We think there\'s a big

15 problem with the drugs that pass through. BSEs,

16 we do think there\'s a risk, particularly from

17 spilled feed; but we think that there\'s the

18 other issues in terms of the feeding of blood

19 meal, and that is a much higher priority for our

20 organization.

21 DR. LUMPKIN: Thanks for

22 clarifying that.

23 We have now reached the point

24 in our agenda where we\'re supposed to have a

25 break until 3:00 when we will begin the time for

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1 individuals who did not register to talk. I\'m

2 aware of one individual who has expressed a

3 desire to present to the panel, so I will

4 recognize that person at 3:00. If there are

5 others who are in the audience who wish to

6 speak, obviously they will be given an

7 opportunity following that individual.

8 So I will say, let\'s go for a

9 break, and we will reconvene at 3:00. Thanks

10 very much.

11 (A recess was taken.)

12 DR. LUMPKIN: It\'s a little

13 after 3:00, and to be fair to people who were

14 given time to talk, I would like to call us back

15 into session, please.

16 Before we get started, I would

17 simply like to point out for the record that

18 Dr. Dan Machesney has joined the panel as the

19 representative of the Center for Veterinary

20 Medicine at FDA. Dr. Sundlof had to return to

21 Washington early this afternoon and had to

22 leave.

23 As I mentioned before we took

24 our break, this is the time in the program that

25 it\'s been dedicated for testimony from other

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1 interested parties who did not register to speak

2 earlier today. I\'m aware of one individual and

3 I\'ll call on that person now.

4 Chuck Massengill from the

5 National Cattlemen\'s Association.

6 MR. MASSENGILL: I\'m Chuck

7 Massengill, a cattle producer from California,

8 Missouri. I\'m on the National Cattlemen\'s Beef

9 Association, cattle health and well being

10 committee. I want to thank the agency for the

11 opportunity to respond verbally. We will have

12 detailed written response addressing each

13 individual item which will come prior to the

14 November 21st deadline. Thank you all very

15 much.

16 We asked for this time \-- the

17 Cattleman\'s Beef Association asked for this time

18 to respond. We want to provide a very short

19 response, but we wanted to clearly reiterate the

20 basic position of the National Cattlemen\'s Beef

21 Association is that we feel that the rule as it

22 currently exists, with enforcement, is adequate

23 to continue to achieve the goal of preventing

24 the establishment and amplification of BSE in

25 the United States. We feel that any changes in

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1 this rule must be science-based, they must be

2 well documented, they must be well researched.

3 As so many people have repeated, there is so

4 much \-- there are so many people with so much at

5 stake that it\'s just absolutely crucial that it

6 be a science-based program and continue that

7 way.

8 We see BSE as a foreign animal

9 disease. It\'s certainly one of several foreign

10 animal diseases that causes concern. We feel

11 specifically if the disease status of a country

12 is in question, we should stop trade with that

13 country and then ask questions and determine

14 what the actual risk is. We don\'t feel that we

15 should tarry in our decision to protect our

16 economy and our animal industry.

17 We encourage the agency to

18 continue to support research on means to exclude

19 BSE from the U.S.

20 That concludes my short

21 comments, sir.

22 DR. LUMPKIN: Thank you very

23 much.

24 Are there any questions for

25 Mr. Massengill?

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1 (No response.)

2 THE COURT REPORTER: Excuse me.

3 Would you spell your name for me, please?

4 MR. MASSENGILL:

5 M-a-s-s-e-n-g-i-l-l.

6 DR. LUMPKIN: The question was,

7 just for the record, for Mr. Massengill to spell

8 his name, since we didn\'t have it in writing for

9 the record.

10 I know there was some confusion

11 apparently earlier this morning about a comment

12 one of the speakers made, and so I will ask

13 Dr. Solomon to raise that question and the

14 speaker, my understanding is, will answer it.

15 DR. SOLOMON: Richard Sellers,

16 is he here?

17 The question that came up with

18 the comments you made about a submission of a

19 partnership agreement to the agency and

20 whether \-- there was some confusion about the

21 status of that. If you\'d clear that up.

22 MR. SELLERS: Sure, I\'m happy

23 to clarify that. Yesterday we filed our

24 partnership agreement, and unless the acting

25 commissioner signed it yesterday, it\'s not been

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1 signed. It\'s a draft, and we expect to have

2 some negotiations. So it was filed yesterday.

3 DR. SOLOMON: It was a

4 petition, or how was that \--

5 MR. SELLERS: It was a draft

6 partnership agreement with a letter accompanying

7 it asking the agency\'s participation.

8 DR. LUMPKIN: Thank you.

9 Is there anyone else at this

10 time who would like to speak before the panel

11 who did not register to do so?

12 (No response.)

13 DR. LUMPKIN: Going once, going

14 twice.

15 As I mentioned this morning, in

16 the Federal Register notice that announced this

17 meeting, we announced that the hour between four

18 and five would be held for public testimony if

19 people did not register to do so and wished to

20 do it. Under our rules of engagement, we indeed

21 have to be here at the beginning of that hour in

22 case someone looked at that in the register and

23 said \"Oh, I need to be there at four in order to

24 say what I wanted to say before the panel.\" So

25 what I will do now is spend this meeting from

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1 now until four. We will reconvene at four to

2 check to see if, indeed, anyone is available,

3 anyone who wanted to talk at the appointed hour

4 in the FR notice. If there is no one here at

5 four, I will conclude the meeting at that

6 point.

7 So for right now the meeting is

8 suspended and we\'ll reconvene at four to make

9 that check.

10 (A recess was taken.)

11 DR. LUMPKIN: Ladies and

12 gentlemen, it\'s 4:00 by my watch. I\'m calling

13 this hearing back into session.

14 The purpose of the hearing at

15 this point is to ask if there are any others who

16 did not register this morning who would like to

17 make comments before the panel. If they do,

18 please come forward now.

19 (No response.)

20 DR. LUMPKIN: Going once.

21 Going twice. Sold.

22 Okay. Thank you.

23 Before we close, I would like

24 to again thank our colleagues here in Kansas

25 City for the wonderful work they did to make

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1 this happen, to thank all of you who are still

2 here and have stayed with us all day and those

3 who chose to leave earlier for their comments.

4 With that, I declare this Part

5 15 hearing closed. Everybody have a safe trip

6 home.

7 (The proceedings concluded at

8 4:03 p.m.)

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1 C E R T I F I C A T E

2

3 I, LINDA R. BURT, a Certified

4 Shorthand Reporter of the State of Kansas, do

5 hereby certify:

6 That said foregoing testimony was

7 taken down by me in shorthand at the time and

8 place hereinbefore stated and was thereafter

9 reduced to typewriting under my direction;

10 That the foregoing transcript is a

11 true record of the testimony given by said

12 witness;

13 That I am not a relative or employee

14 or attorney or counsel of any of the parties or

15 a relative or employee of such attorney or

16 counsel or financially interested in the action.

17 WITNESS my hand and seal this \_\_\_\_\_

18 day of \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_, 2001.

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20 \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

21 LINDA R. BURT, C.S.R.

22 Certified Shorthand Reporter

23 State of Kansas

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