ANIMAL FEED SAFETY SYSTEM PUBLIC MEETING

CROWNE PLAZA HOTEL

655 NORTH 108TH AVENUE

OMAHA, NEBRASKA

APRIL 5 AND 6, 2005

DOCKET NO. 2003N-0312

Transcribed from Audiocassette

I N D E X

APRIL 5, 2005 PAGE

Introduction by George Graber, Ph.D. . . . . 5

Deputy Director,

Office of Surveillance & Compliance

Center for Veterinary Medicine

(8:30 a.m. - 8:40 a.m.)

Welcome by Daniel McChesney, Ph.D. . . . . . 11

Director, Office of Surveillance &

Compliance Center for Veterinary Medicine

(8:40 a.m. - 8:50 a.m.)

Framework by George Graber, Ph.D. . . . . . 19

(8:50 a.m. - 9:05 a.m.)

\"Comprehensive\" Definition . . . . . . . . . 34

by Shannon Jordre

Division of Compliance

Center for Veterinary Medicine

(9:05 a.m. - 9:20 a.m.)

\"Risk-based\" Definition and Risk Ranking . . 44

by Barry Hooberman, Ph.D.

Office of New Animal Drug Evaluation

Center for Veterinary Medicine

(9:20 a.m. - 9:50 a.m.)

Safe Feed Ingredients . . . . . . . . . . . 73

by John D. McCurdy, Ph.D.

Division of Animal Feeds

Center for Veterinary Medicine

(10:20 a.m. - 10:35 a.m.)

Limits for Animal Feed Contaminants. . . . . 82

by Karen Ekelman, Ph.D.

Division of Animal Feeds

Center for Veterinary Medicine

(10:35 a.m. - 10:50 a.m.)

Process Control. . . . . . . . . . . . . . . 98

for the Production of Feed

by Paul Bachman

Division of Compliance

Center for Veterinary Medicine

(10:50 a.m. - 11:05 a.m.)

INDEX CONTINUED

PAGE

Regulatory Oversight . . . . . . . . . . . 108

by Steve Traylor, Ph.D.

Division of Regulatory Services

University of Kentucky

(11:05 a.m. - 11:20 a.m.)

Breakout Group . . . . . . . . . . . . . . 116

Explanation and Instructions

by Gloria Dunnavan

Director, Division of Compliance

Center for Veterinary Medicine

(11:20 a.m. - 11:40 a.m.)

APRIL 6, 2005

Robert Wilson, Moderator . . . . . . . . . 123

Kansas City District Office

Food & Drug Administration

(8:00 a.m. - 8:05 a.m.)

Bruce Arentson, Kent Feeds . . . . . . . . 125

Group A

Sara Blodgett, Farmers Coop . . . . . . . . 137

Group 1B

Michael Davidson, Republic of . . . . . . . 140

California Department of Food

and Agriculture

Group 2B

Amy Wesley, Murphy-Brown, L.L.C. . . . . . 146

Group 2A

Blaine Hull . . . . . . . . . . . . . . . . 155

Group 3A

Randy Sample, ADM Alliance Nutrition. . . . 166

and Animal Health Nutrition

Group 3B

Judy Thompson, Canadian Food . . . . . . . 183

Inspection Agency

Group 5A

INDEX CONTINUED

PAGE

Charles Breen. . . . . . . . . . . . . . . 190

Seattle Regional Director, FDA

Group 5B

Dan Danielson. . . . . . . . . . . . . . . 199

Tennessee Department of Agriculture

Group 4B

Marlene Petersen, Milk Specialties . . . . 209

Group 4A

Randy Gordon . . . . . . . . . . . . . . . 222

National Grain and Feed Association

Group 6A

Liz Wagstrom, National Pork Board. . . . . 231

Group 6A

Bill Grande. . . . . . . . . . . . . . . . 249

Group 6B

Open Discussion. . . . . . . . . . . . . . 270

Moderated by Gloria Dunnavan

(11:45 a.m. - 12:15 p.m.)

Closing Remarks by George Graber . . . . . 284

(12:15 p.m. - 12:20 p.m.)

\*\* \*\* \*\* \*\*

APRIL 5, 2005

INTRODUCTION BY GEORGE GRABER, Ph.D.

DR. GRABER: I think we\'re gonna

\-- we\'re gonna start. We\'ve got a tight

schedule, and there\'ll be some time for

visiting a little later this morning, and then

this afternoon, you\'ll have plenty of time to

talk to each other.

My name is George Graber, and I\'m the

Deputy Director of the Office of Surveillance &

Compliance in the Center for Veterinary

Medicine, FDA. What I want to do for the next

few minutes is just run over some logistics,

some administrative issues, and then Dan

McChesney will give the introductory \-- or the

welcoming remarks.

First, and probably foremost, for

those of you who have cell phones with you,

could you please turn off the ringer? It would

be much appreciated.

Second of all, you should have \--

Each of you should have your, your packets,

your infor \-- you know, the red, red folder,

and what I want to do is just go through some

of the items that are in that folder.

Next \-- Okay. There\'s \-- In the

folder, you should have a CVM update, that came

out in February, announcing this meeting.

There are also copies of the Federal Register

notices of March 31st of last year and February

7th of this year. The notice of March 31st of

2004 gave you the docket number and also

identified the, the definitions for risk-based

and comprehensive that we have added to the

docket \-- the FDA docket, and also, provided

the basic elements of a process-control system.

So these were put out for public display. They

were draft comments \-- or draft documents for,

for you to consider.

You\'ll also find, in the packets,

some information dealing with risk. Some of

the slides that\'ll be used today are included

in the packet because they had not been

released previously.

There is also the, the framework

document, which we \-- most of what we\'re gonna

be talking about this morning, this draft

document that\'s, I think, eight \-- seven or

eight pages.

There is also \-- This afternoon,

everyone, with a few exceptions, will be

assigned to different breakout groups, and, and

you see that on your badge, what your breakout

group number is. Within your packet, there\'s a

listing of the breakout groups and the \-- and

the diagram in the hotel for where these

breakout groups will be.

You\'ll be meeting at lunch, and lunch

will be served in the Regency Room, which is

around \-- somewhere towards the back of the

hotel, and the breakout groups will be \-- will

be eating together, so there\'ll be cards on

the \-- on the placard \-- on the tables

indicating what your breakout \-- where your

breakout group will be having lunch.

There\'s also a list of, of

registrants for the meeting, at least as of the

end of last month. If everyone had showed up,

we would have had somewhere around 210 people

here registered. We don\'t anticipate that, as,

in most cases, things come up, and we\'re not

anticipating everyone will be here, but looking

at the size of the room, it looks like we have

pretty close to a full house. There are some

seats right up here in the front row, believe

it or not. They got bird\'s-eye view of the \--

of the slides, and \--

There\'s also speaker bios, number \--

The people who will speak, just about everyone

is, is a member of the Animal Feed Safety

System Team, and rather than go through and

introduce speakers, other than their name and

what they\'re gonna be talking about, if you

want to read anything about the backgrounds of

the people, that\'s \-- it\'s in the \-- it\'s in

your packet.

There\'s also comment cards and an

evaluation form, form to fill out at the end of

the \-- at the end of the \-- tomorrow, and the

comment cards, you can fill out comments and

questions and stuff. There are boxes in the

back of the room, on the table, to put both the

cards and the forms in.

(A cell phone rings.)

DR. GRABER: There\'s our first

cell phone. Okay. Where is the hook?

Okay. The \-- There\'s also a sheet

identifying \-- There\'s a reception this evening

from 6 to 7:30. It\'s in the Regency Room.

It\'s a cash bar, but there should be plenty of

food there.

And then the last item I\'ve

identified is the meeting agenda, and like I

said, this morning there\'ll be presentations by

the members of the Animal Feed Safety System

Team covering the framework and then each of

the components that we\'ve identified in the

framework and then, also, the discussions on

risk and, and also the risk-ranking method that

we\'re utilizing \-- or considering to be

utilizing. And there will also be some

discussion about the definitions of risk-based

and also comprehensive.

There will be \-- At the end of the

morning, there will be a time set aside \--

there is a time set aside for introduction to

the breakout groups, so you\'ll get a lot more

background about what\'s gonna be expected of

you and how that\'s \-- and how that\'s all gonna

occur.

And if time permits this morning,

between speakers, we will entertain a few

questions. There are people scattered

throughout the, the room here with mikes, so if

you raise your hand, at this time \-- and if you

raise your hand, then we\'ll turn to you, and

you\'ll ask your question. Just identify

yourself, name and affiliation, and ask the

question. And I\'m not guaranteeing we\'ll have

time, but if we do, we\'ll take \-- we\'ll take a

question or two.

Like I said, this afternoon we\'re

gonna have breakout groups. You\'ll have a

series of questions that you\'re gonna be

working on. Again, lunch will be served. So

looking forward to, to hearing your reports,

which will be done tomorrow, tomorrow morning.

We\'ll have a full schedule tomorrow morning,

and then there\'ll \-- at \-- some time for some

open discussion before we close the meeting a

little after 12.

Okay. I think I\'ve covered

everything I wanted to cover. I think \-- One,

one thing I didn\'t mention, the, the names of

the facilitators are also in your packet. The

facilitator for 2B, the name needs to be

changed. The, the new person\'s name is Natalie

Vacanti, V-A-C-A-N-T-I. And, in fact, the

facilitators are here. Maybe they can stand

for a minute, you can recognize who they are.

They\'re the younger people, and in my case, the

much younger people. Okay. That\'s to get

everybody to come to the breakout rooms,

so anyhow . . .

Okay. The welcoming remarks will be

given by Dr. Dan McChesney, who is the director

of the Office of Surveillance & Compliance in

the Center for Veterinary Medicine. Dan?

WELCOME BY DANIEL McCHESNEY, Ph.D.

DR. McCHESNEY: Good morning.

Just start with the next slide. We know who I

am.

What we\'d like to do this morning is

welcome you to Omaha. And many of you may ask

why Omaha, since we did this, oh, a year or so

ago, year and a half ago, and we did it in

Washington, D.C., and all the familiar faces

from Washington were there, all the trade

associations were there, but we decided, since

this Animal Feed Safety System is going to

focus, really, on the animal feed industry,

that it might actually be wise to come to

someplace in the country where the animal feed

industry is actually located. There is not

much of it in Washington, D.C., although there

is some rural parts, not much. So we\'re here

in Omaha with the idea of hoping to have

participation from producers in the feed

industry, and basically, looking at the

registrants, I think we have accomplished that.

The focus of the meeting, as George

already said, is really the framework document

that was developed at \-- with the comments from

the first public meeting and then a method for

risk method discussion of how we might look at

risk. Next slide.

Reasons we\'re here. Well, animals

are \-- We all know animals are important to our

society for two reasons: one, when they\'re

pets; and two, we eat \'em, which is an

interesting concept between both of those.

Food and feed are important to animal health.

I think we need a more uniform way of

addressing safety issues. In the past, we\'ve

sort of done it on an ad hoc basis. When a

safety issue came up, we\'d decide how we deal

with it, what \-- how we proceed. We actually

need some way to look more uniformly at that,

have some things in place for what we\'re going

to do, what actions we\'re going to take. And I

think one, one example of where that\'s played

out is in the response on the \-- for BSE in the

\-- on the feed side of the house, but also on

the animal side of the house.

Between FDA and U.S. Department of

Agriculture, we have lots of plans laid out of

how to respond to \-- when there\'s been a

notification of a BSE incident like we saw up

in the state of Washington or the Canadian

animals, how to attract the feed, how we talk

to each other. So that\'s a very well-laid-out

system, with very defined things of who we\'re

going to be contacting. We need to look at

doing that for the other, other types of

contaminants.

And we, first of all \-- Most

importantly, we need to better utilize the

resources of both FDA, the states and the

involved industries. And up here \-- This

picture on the top here is from a CVM picnic we

had last April, and just \-- I think it\'s a

little microcosm of what we have here today.

All the people here are actually CVM employees,

and it\'s hard to see in the back, but they\'re

all sort of pointed in one direction. They\'re

all sort of looking ahead, and I think that\'s

what we have with the group here today. The

Animal Feed Safety people that are here, the

FDA folks and the state folks that were

involved all sort of have a vision of where the

Animal Feed Safety should go. It\'s not a

totally common vision, but they\'re all at least

looking in the same direction.

I think most of the rest of the

audience is sort of reflected by the dogs down

here, who are \-- There\'s some looking in every

direction. I mean, this one is completely

turned around, obviously totally opposed to the

whole system, and there are just a bunch of

\'em, all going individual directions, with all

different opinions, and then we have this

little black fella sitting out front here who

seems to be willing to listen to all sides, and

I think that\'s what we\'re looking for this

morning. I think most of the folks in the

audience have lots of opinions that we want to

gather, but you need to be willing to listen to

each other and not come, you know, with your

own position and just state it and keep stating

your position. So we ask you to be open to it,

sort of like this fella sitting here. And at

the end of the day, maybe we\'ll all sort of be

looking, you know, sort of forward, maybe even

if we\'re looking out the side of our eyes, but

at least we\'ll be looking forward. Next slide.

The next three slides just sort of go

to the fact of why do we need something and

what\'s happened over the years for

feed-contamination-type issues. And we\'re not

going to go through each of these, but the

important point is to just look at the

diversity of the things that we have up here.

So we have mercury. We have salmonella

bacteria. We have P \-- PBBs, PCBs. Monensin

down here at 94 is an (inaudible). Monensin is

a drug \-- an approved drug, and in this case,

it was used in the appropriate manner and

resulted in about 600 cattle being dead in the

Midwest here, and as it turned out, when we did

do an investigation, we found out that the

animals were being fed distillers\' dried

grains, which turned out not to be the problem,

but mixed in with that was a fermentation

byproduct from the pharmaceutical industry,

which is not part of the definition of

\"distillers\' dried grains,\" and it turned out

to potentiate the uptake of monensin and killed

6 to 700 cows. So a preventable problem. Just

had to lead out \-- leave out the pharmaceutical

byproduct, but still, where you can take an

improved product, use that approved dose and

have bad results. Next slide.

Salmonella and pet treats coming in.

We have a real concern about salmonella in pet

products because they come into the home,

they\'re direct to consumer. So that\'s one.

We all know fumonisin, the horse

deaths. Those of us in FDA and usually in

Kentucky, we make a big point of this every

three or four years \'cause we kill 30 or 40

horses. You don\'t feed \'em grain \-- You don\'t

feed \'em corn screenings because of the

potential for fumonisin. Everybody learns from

that, and then three years later we kill a

bunch more horses in the same \-- in the same

state or adjacent states because they\'re back

to feeding corn screening. So we just need to

kind of keep things in perspective.

BSE, we all know about that. I think

we\'ve addressed that fairly well. Next slide.

Dioxins, surely a problem that we\'ve

known about. One of my most \-- One of the most

favorite quotes I\'ve heard in this came from

someone who is not actually in the room but was

not a state or federal person, nor a producer,

and when I mentioned that dioxin was a problem,

\'cause we had a problem with boil clay trace

minerals and baghouse dust, the comment was,

Well, we\'ve only had three \-- we\'ve only had

three problems with dioxin over the past 10 or

15 years, and I said, That\'s true, but each of

those problems were preventable if the company

had actually tested for \'em or not used the

product. So, you know, ignorance is not an

excuse for not doing something that\'s right and

safe, so we\'re trying \-- We need to try to get

away from that. That\'s why we\'re looking at a

total system here.

More recently, several horses died in

Puerto Rico. Really never did figure out why

that happened, and even more recently,

didn\'t \-- so recent it didn\'t make the slide,

several cows died in Hawaii for no real

apparent reason. We looked at all the feed and

everything else and really could not put a

handle on why it is. So there are surely

things out there that we do not know about.

Next slide.

And I think this is almost the last

slide. What we saw \-- Those of you that

attended the first public meeting \-- and

there\'s a number of you in this room \--

Dr. Sundlof, our Center director, said at that

time, The feedback you provide is absolutely

critical to making this system work, and that\'s

true, and if we think back to, like, the, the

slide with the dogs and the people on it,

that\'s sort of the feedback we\'re looking for

today.

We need your active participation. I

know breakout groups can sort of be trying and

things like that, where you\'re actually forced

into a group and, you know, forced to interact

with people and provide your opinions as to put

\-- sitting in a room with 200 other folks and

just sort of being an anonymous person here.

So we \-- I really encourage you to actively

participate in this. We want your views. We

need your ideas. The people that are in the

groups with you surely can, you know, help you

draw those out. You can draw theirs out. We

need your feedback in order to develop \--

further develop the Animal Feed Safety System,

and the only way we\'re gonna get that is if you

actively participate today. Sitting there is

not what we need. Next slide.

And finally, I\'d like to thank you to

(sic) coming to this meeting, and I don\'t have

the agenda, so I don\'t know who I should

introduce next. George?

FRAMEWORK BY GEORGE GRABER, Ph.D.

DR. GRABER: In my haste to, to

introduce Dan, I missed the last slide. Some

important information on there, so \-- Okay. As

I indicated, there\'ll be a facilitator for each

of the \-- each of the breakout groups, and the

people facilitating are an organization here

in, in Omaha called planitOmaha, and those were

the people who stood up in the back of the

room.

One thing I did want to point out is,

is that we are taping this session this morning

and tomorrow morning\'s session, and that

information then will be transcribed and placed

on the docket for the \-- the FDA docket for

this meeting, and in your packet, there\'s a

card that identi \-- Inside the bottom \-- Inside

your packet, there\'s a little \-- one of the

business cards that has the docket number on

it. Should you wish to submit comments at the

docket, you could do that at any time. There\'s

no closing point \-- no closing period, at this

\-- at this particular stage, with regard to

that docket.

Now, one thing we will not be doing,

we will not be taping the programs \-- the

breakout groups this afternoon, so there is \--

there is no tape recorders in there, so people

are free to speak. Nobody is taking notes

other than yourself, other than the group in

terms of reporting back, so . . .

Okay. Let\'s move on to \-- I\'m gonna

go through the framework document a little bit

now. We\'ll be taking a break, I guess, around

9:50, and we\'ll have coffee and \-- outside

there, so for those of you who need the

caffeine, if you can wait a little bit,

appreciate it.

Okay. Dan went into this a little

bit, why this public meeting, and one of the

things we had said at the meeting in Herndon,

Virginia, back in September of 2003, that we

wanted to make this as transparent a process as

possible, and that \-- You know, that becomes

somewhat difficult for, for the federal system

to comply with that, but one of the reasons for

having this meeting, one of the reasons for

putting the draft documents up on the \-- in the

docket were, in fact, to get \-- solicit

comments.

And so we are presenting, in stages,

the work products that we have developed as a

group, and I\'m a firm believer that while

this \-- the work products that you have in your

packet and you\'re gonna hear about today may

represent close to the best product we can

develop, we don\'t think it\'s the best product

that will be eventually developed, because we

don\'t have everyone else\'s input at this point.

So that\'s \-- It\'s fairly important for us to

get that input and ideas and concepts, so \--

And one of the things \-- One of the

reasons for coming out here, as Dan mentioned,

was to get \-- to get a wider section of people

to come especially, and one of the things we

tried to do at \-- by coming out here is, is \--

We\'ve always had good attendance from the feed

side. We were trying to get more producer

groups to this meeting, and we think we\'ve

gotten a few to come to this meeting that, that

hadn\'t been at the meeting in Virginia,

so . . . And we also can \-- You know, we want

to see continued stakeholder input. Again,

that\'s why the information about submitting

comments at a docket, because, you know, even

now, this thing isn\'t over when this program is

over. We\'re gonna continue to work on this.

Okay. Next slide.

Again, the objective of the Animal

Feed Safety System is to develop a

comprehensive risk-based system for feed

manufacturer distribution and use, with the

goal in mind of minimizing the risk to both

human and to animal health. It\'s a long-term

project. It\'s one that we started two years

ago, and right now, the, the work is supposed

to be completed in the year 2007 \-- fiscal year

2007\. A lot of that\'ll depend on what, what

products we eventually decide to work on, and

you\'ve got some indication of that in your

packet.

The Animal Feed Safety System Team is

made up of 22 members. They\'re \-- On the next

slide is the list of all the people. 20 of the

22 members are here at the meeting. You\'ll \--

There\'s \-- gonna be making presentations from

\-- some are making presentations from here this

morning. They will also be in your breakout

groups, and they represent \-- A lot of the

people are from the Center for Veterinary

Medicine. We have somebody from the Office of

the Commissioner, who is serving on the team,

and several people from our Office of

Regulatory Affairs representing the Kansas City

district and, and also San Francisco, and we

have several \-- two state people on the \-- on

the team representing Kentucky and, and

Wisconsin. Okay. Next slide.

Again, the idea is to develop a

comprehensive system that\'s \-- that covers \--

It\'s just \-- It\'s not just regulations that it

covers. It ties together issues dealing with

policy, guidance, programs in general. One

thing I, I believe there, there seemed to be at

least a great deal of misunderstanding is that

we\'re not really starting from scratch. I

mean, we\'re not starting from a \-- with a blank

sheet of paper. We\'ve been in the business of

\-- \"we\" being FDA \-- been in the business of

regulating animal feed for many, many, many

years and have a long history here, and the

states, likewise, have had a long history of

regulating animal feeds, but what we\'re trying

to do is identifying the gaps that exist, the

things that aren\'t in place at the present

time, to make the system more comprehensive.

Again, that\'s why the definition of

\"comprehensive\" is, is very important. And the

idea of \-- also, to introduce the concept of

risk into, into decision-making within the

agency. Again, that\'s not new. The agency has

always used risk, but we\'re trying to do it in

a little bit more systematic manner now.

In the \-- In the framework document

that\'s in your packet, we\'ve identified seven,

seven operating principles that we thought was

important to, to put down on a piece of paper

to ensure that \-- ourselves that we were clear

about what it is \-- where we were going and

what our responsibilities are, but the \-- It\'s

the industry\'s responsibility. It always has

been. And I know \-- You\'ve said it yourself

for, for years, for \-- responsible for, for

making a safe product and distributing a safe

product and using a safe product. That\'s not

the FDA\'s or the states\' responsibilities. Our

responsibilities are to ensure that process is

working. Do that through various ways.

Regulations is just one way. Guidance

documents, education, conducting inspections.

The oversight capacity is, is what the

government\'s responsibilities are.

Within the Animal Feed Safety System,

while we\'re speaking almost entirely of it

being an FDA program, I think just about

everybody in this room recognizes the

responsibilities and the \-- and the cooperation

that, that the states and the agency have, and

it\'s very important that we continue to have a

real strong, robust federal/state cooperative

program. It\'s really paramount.

We\'re also talking about that the

program will continue to have the various basic

features that exist today. There may \-- The

ratios of some of these may change, there may

be greater emphasis in some areas than others,

but we\'ll continue to do inspections. We\'ll

continue to do label reviews. We\'ll continue

to check for guarantees. We\'ll do sampling and

checking for contaminants. But like I said,

within the Animal Feed Safety System, you may

end up with more focus on safety and less on,

on economics, but that doesn\'t necessarily mean

that economic issues are gonna disappear.

We\'ve indicated also that we\'re

gonna \-- You know, the agency has \-- does not

have finite resources, very limited number of

resources, and the idea is to try to focus our

resources on, on those issues that are the

most \-- offer the most risk to, to human and to

animal health, and we hope to be using the

risk-based decision-making, and you\'ll hear

more about that today, about \-- a little bit

more about how we\'re gonna go about doing that.

And where feasible, we \-- we\'re going to

introduce feed security measures as they relate

to the counterterrorism ex \-- situation that

we\'re currently going through and will continue

to, to happen in front of us for \-- probably

for years and years to come.

Okay. The four components \-- what

I\'ll call \"structural components\" of the Animal

Feed Safety System \-- deal with having safe

ingredients, ones that are \-- been found to be

acceptable for use. There are limits that are

established for the various contaminants that

could find their way into animal feed. The \--

We have a processing control, an important

component of, of the system, and then from the

agency\'s aspect, there is the regulatory

oversight. So these are sort of the four

cornerstones of, of the Animal Feed Safety

System.

And from the viewpoint of regulation,

and just using this, this as an example, you

have \-- For ingredient acceptability, you

have \-- In the Code of Federal Regulations,

Title 21 is the Food and Drug section of the

code. CFR stands for the Code of Federal

Regulations, and Part 573 has the issues

dealing with, with food additives, and it has

the listing of, of the food additives that are

approved and gone through a formal review

process. And then this section here, 21 CFR

73, has all the color additives that are

approved for use in human food and animal feed.

Then there is \-- An example here, there\'s the

prohibitive proteins regulations dealing with

prevention and spread of \-- potentially, of

BSE.

For contaminant limits, salmonella,

there\'s a regulation for salmonella in the Code

of Federal Regulations, again, part 535, and

that\'s \-- For those, those of you who don\'t

know, that, essentially, has been on the books

for over 30 years.

And then we have process control

regulations, the medicated feeds. \"G\" \-- Good

manufacturing practice regulations are in 21

CFR 225, and low-acid canning regulations are

in the human foods section of the Code of

Federal Regulations.

So these are examples, at least for

the first three structural components on the

regulation side, again, indicating that, you

know, there are things in place already. I

mean, again, we\'re starting from scratch.

And as Dan mentioned, the \-- and I\'ve

said before, the first public meeting we had

back in September of, of 2003 was in the

Washington area, in Herndon, Virginia, and we

had, probably, a comparable turnout for that.

There was \-- It was quite rewarding. We had

what I thought were some excellent

presentations and great feedback from, from the

breakout groups, and, and we utilize that in,

in developing the draft definitions for

comprehensive and risk-based and the essential

elements of any process control system that we,

again, announced back in 2004, and then this

meeting here, we\'re, we\'re looking for a repeat

in terms of productivity.

And, and I know that the framework

document, you\'ve had an opportunity to look at

and, and read. Whether you\'ve taken that

opportunity is another story, but the

risk-ranking situation, you\'ll be \-- hear some

of that this morning for the first time, so

stay tuned. Be alert.

The four structural components and

the terminology that we\'ve used in the

framework document is \-- are the ingredients in

the approval process: limits for animal feed

contaminants, process control for the

production of feed ingredients and mixed feed,

and then the regulatory oversight component.

And the basic framework or the basic format for

each one of these components that are in the \--

in, in \-- again, in your handout, we have an

objective, a scope, a short description of that

particular component and then what I call the

process prescriptions. Where \-- In the Code of

Federal Regulations or in the AAFCO book or

wherever, where can you find the information

that we\'re talking about? Where, where are the

processes that lead to, for example, safe

animal feeds? And then there \-- Where are they

\-- Where are they described \-- The process for

going \-- for, for developing safe animal feeds,

for example, then the listings, where are those

listings? Where can you find the listings of,

say, feed ingredients? And then last but not

least is the gaps \-- the things that we\'ve

identified as, as \-- at least at this stage,

that need to be developed in order to make the

system comprehensive.

Again, these are drafts. We\'re

really looking forward to a good discussion

about, about the gaps section, and that\'s, to a

large extent, what the breakout groups will be

focusing on. There are some specific questions

and, again, presentations this morning \-- later

this morning we\'ll be getting to, to give you

some insight as to what those gaps are and how

to go about working on the breakout groups.

Okay. Timewise, let\'s see where we

are. We may have time for a question or two.

Let\'s see. 9:02. Yeah. We got a couple

questions \-- couple time \-- minutes. I\'m

sorry. We got a couple minutes. Barbara?

Somebody right behind you.

MR. NORTHRUP: Arnold Northrup,

Garvey Processing. I agree that we\'re not

starting from scratch, those of us in the feed

industry, but some of those brought in by the

term \"comprehensive\" are really starting from

scratch, producers, as well as transporters,

and I\'m wondering how you\'re gonna catch them

up to speed and who\'s gonna do it.

DR. GRABER: Well, I think this

is a start. We\'re obviously \-- You know, we\'ve

got some people here at the meeting. We\'re

gonna have to work at that to, to get some of

these groups to come to the table, and we\'re

gonna have to devise some means for doing that,

and, and that may be some of the work that

comes out of the breakout groups today, as

well.

Question, Tim?

MR. HERMAN: Yeah. Tim Herman,

Office of the State Chemist. How do you feel

that the gaps identified by AFSS line up or

align with the recent GAO report?

DR. GRABER: Which, which GAO

report?

MR. HERMAN: As it pertains to

BSE and the gaps that were identified there.

DR. GRABER: BSE? You\'re

talking about the BSE report, or are you

talking about the Animal Feed Safe \-- animal

feeds?

MR. HERMAN: Well, the one that

was on the front page of \--

DR. GRABER: Oh, okay.

MR. HERMAN: \-- Feedstuffs

here \--

DR. GRABER: Okay.

MR. HERMAN: \-- last issue.

DR. GRABER: Last, last issue?

Yeah, I haven\'t seen that issue. Okay. Well,

I \-- You know, I think the \-- There is a group,

you know, within the agency. Obviously, it\'s

working on, on BSE, and that group will

continue to work on BSE, and whatever gaps were

identified there, we\'ll try to fill, but for

the most part, we thought that the, the gaps

that \-- or at least the issues that were

identified by GAO, the agency has been working

on. We didn\'t totally agree with all the, the

items identified by GAO, and, and we \-- and our

responses, which are part of the record, part

of the GAO report, do identify where we agreed

and where we disagreed, so . . . This

particular group is not gonna be focusing

purely on BSE. The Animal Feed Safety Group

is, is working on some other areas.

Got a question up front here? Hold

\-- Wait up a second, sir.

MALE VOICE: In this global

economy, how can you walk this narrow line

between emotional response and

scientific-based \-- risk-based responses?

DR. GRABER: You got any clues?

I, I think \-- I think you \-- I think we have to

\-- You know, we have to be realistic. We\'re

gonna try to be as, as scientifically oriented

as we possibly can, but I think we all have to

recognize that there are other factors that

weigh into decision-making, and, and that\'s

just the reality of things in this democratic

society. There are political issues. There

are trade issues. I mean, the BSE is an

example of one that \-- where all these other

factors play a role. But I think, for the most

part, you know, as \-- at least \-- at least

from, from where I\'m standing, we\'re gonna try

to be as scientifically oriented in our

decision-making as we can.

Okay. We\'ve reached 9:05, and the

next presentation is by Shannon Jordre, who is

with our Division of Compliance, and he\'s going

to be covering the \"comprehensive\" definition.

Shannon?

\"COMPREHENSIVE\" DEFINITION

BY SHANNON JORDRE

MR. JORDRE: Go ahead. Oh,

thank you, Ferris. Well, I can see there\'ll

already probably be some questions about the

definition for \"comprehensive,\" and so if we

get some time, we\'ll, we\'ll try to respond to

those more specifically.

I\'d also like to take this

opportunity to welcome everyone to Omaha.

Thank you for, for coming to our meeting. As

you know, this group, the Animal Feed Safety

System Team, has been working for a couple

years now, and we\'ve, we\'ve been referring to

our program as a \"comprehensive\" or as an

\"umbrella-type\" program, a way to approach feed

safety. Well, I worked with a small team of

people to try and flesh out what we mean by

\"comprehensive,\" and that\'s what I\'m gonna

report on today.

Webster\'s \-- As you can see on the

screen, Webster\'s defines \"comprehensive\" as

covering completely or broadly and inclusive.

The Webster\'s definition is really very simple,

and although it\'s simple, it really doesn\'t say

anything about animal feed or feed safety, so

we try to customize this definition a little

bit to suit our purposes here. Go ahead,

Ferris.

And just to \-- And to throw in a

little humor here, here is a group of

inspectors touring a feed mill, and they\'re

wondering if their hard hats provide

comprehensive protection from the pigeons that

are sitting up on the tower at that feed mill,

and \-- not unlike the \-- kind of, the, the

program we\'re discussing here. We\'ve got \--

We\'ve got all kinds of rules, hard hats in

place, if it were, but do they cover

everything? And that\'s what we\'re trying to \--

trying to work out here. Go ahead.

So what is a comprehensive Animal

Feed Safety System? We did public a draft

definition on March 31st, 2004, in the Federal

Register, and through this series of slides,

I\'ll try to lay out the, the concepts we

thought should be incorporated in a draft

definition, make a few comments about each of

those concepts and, and perhaps highlight some

of the comments that we\'ve received to date.

So the Animal Feed Safety System, or

AFSS, as we call it, comprehensively would

apply to the whole range of feed products,

including all ingredients and all finished

feeds, and as we just heard a minute ago, some

feeds and some feed ingredients are produced

outside of our traditional feed-controlled

jurisdiction. Other materials may never make

it into commercial commerce, for example, and

may not be subject to state feed laws. In

order to provide a seamless system, it will be

necessary for us to identify exactly where our

authority stops and where the authority of

other regulatory agencies start. Some of these

other agencies might be USDA, EPA, the

Department of Transportation and, of course,

the state regulatory agencies that we work with

all the time. Go ahead.

The Animal Feed Safety System would

require the use of ingredients that are

approved and/or recognized by an established

mechanism of an appropriate regulatory agency,

so this would be FDA, this would be the state

feed-control agencies. You cannot have safe

feed without safe ingredients, and how does

someone know whether an ingredient is safe

unless it has gone through some type of \-- some

type of approval or recognition process? We

intended for this concept to include

ingredients that have been approved by FDA,

those, those ingredients that have been defined

and are listed in the AAFCO publication, and we

know there is a number of other processes that

are also available.

We did receive some comments. People

said, Well, don\'t forget about grass

notification and things, and we haven\'t. We\'ve

\-- Just in generic term, we feel that those

processes were already recognized by FDA. We

don\'t need to, at this stage, anyway, go into

too much more detail. Go ahead.

Facilities and equipment. We think

the AFSS would cover the complete range and

variety of facilities involved in animal feed

production. This concept would apply across

the board, from small on-farm feed

manufacturing operations to large multinational

corporations. All facilities and equipment

that would be used to manufacture and

distribute feed would be covered.

Now, historically, some of these

industry segments have not systematically been

regulated, and some of these operations may not

be aware of the requirements that are already

in place that they are supposed to be meeting,

so we do recognize that there will probably be

quite a bit of an educational component to the

Animal Feed Safety System, and I think, in

general, the comments that we did receive

pretty much agreed with us, although they did

say we need to make it a little more clear that

we\'re gonna cover transportation, make sure

that you talk \-- that we\'re \-- we plan to cover

the farm, as well. Go ahead.

Flexible. The AFSS should have the

flexibility to be process- or product-oriented,

depending on the situation. I guess our team

felt that we can\'t predict the development of

new processes or new products, and it is not

our intent for the AFSS to be overly

prescriptive, and, and we don\'t intend to

dictate a particular approach, such as HACCP or

any other particular approach across the board,

but we\'re not sure what other types of control

systems may be available, so we\'re very

interested in receiving your comments on this

particular component. Even within our team,

we\'re \-- we had some discussion back and forth

as to what, what is process-oriented \-- or \--

Well, we know \-- We, we think we know what the

process-oriented controls look like, but

product-oriented, we had some discussion as to

what that might mean. So we\'re very open to

your comments on that.

All animals. The AFSS should address

feeds produced for food and nonfood animals.

And why, might you ask? \'Cause we\'re not

eating cats and dogs or other pets. Well, it,

it boils down to simplicity, at least from our

perspective. Most of the feed ingredients are

used in a wide variety of species\' feeds, and

for consistency and ease of implementation, we

feel that the AFSS should apply, across the

board, to all feeds.

Hazards. The AFSS should cover all

known hazards and be applicable to hazards not

yet identified. And if there was some

heartburn expressed in the comments, this was

probably where most of it got expressed, and I

don\'t say that in a bad way. People did

express their nervousness with our use of the

terminology \"hazards not yet identified.\"

Well, how can you \-- You know, how can you make

us address hazards that have not iden \-- been

identified yet? And someone else said, Well,

if you mention the word \"all hazards,\" aren\'t

you being kind of absolute? And that\'s a good

point. I guess our intent here is that we just

\-- we just want the AFS \-- the AFSS to be as

robust as possible, to be well designed, to

accommodate as wide a range of potential

hazards as possible.

Now, the question has come up: What

about acts of vandalism or terrorism, things

like that? And although we certainly may not

be able to anticipate or stop every act of

terrorism, for example, we do think that if we

have the AFSS in place, it certainly should

provide some degree of mitigation and help the

situation.

Health protection. The AFSS would

address both animal and human health issues.

The system we have in place now seems to do a

pretty good job of protecting human and animal

health once the problem has been identified;

however, we think \-- we think we could develop

a more systematic approach that may allow you

to predict where problems may occur and help

prevent those problems from occurring.

Regulatory oversight. The AFSS would

acknowledge and coordinate regulatory oversight

at all levels, including local, state, tribal

and federal, any agency who is involved in feed

safety. As, as a follow-up to this, it will be

necessary to identify the agencies involved and

the extent of their authority, and, and we feel

it will be important to coordinate with these

agencies rather than to dictate to them.

We did receive several comments that

suggested that we not forget that there is

currently a program in the works that we call

Voluntary Self-Inspection, or VSIP for short,

and we\'re working on trying to get the pilot

for that going. And we certainly don\'t

intempt \-- or intend, I should say \-- We don\'t

intend to, to, to bypass that, that project.

We have received some additional

comments, and I guess I should say we have not

been inundated with comments, those of you who

have looked at the docket. We have not

received a vast number of comments, but the

comments we have received have been excellent.

Very, very good comments. We did receive some

additional comments from a few people. I, I

thought I would note these, these two comments

in particular: That we should conduct research

to ensure hazard determination is based on

sound science; and that we should facilitate

access to diagnostic tests that will support

the AFSS. These are not things that we wrote

into the program, but certainly, they\'re things

that we have to keep in mind, and that\'s one of

the things that we hope to get out of this

meeting, as well as people commenting to the

docket. Please send us your, your ideas.

These are very valuable comments.

So thank you for your attention this

morning, and we do appreciate your help as we

journey into this new territory. We\'re on

time.

DR. GRABER: Yeah, we\'re on

time, but we\'ll take \-- I\'ll take one question,

if we have one.

Okay. Next on the program is

Dr. Barry Hooberman. He is with risk \-- he\'s a

risk assessment manager in the Office of New

Animal Drug Evaluation in CVM. He is going to

be talking \-- The agenda has him down talking

about \"risk-based\" definition and risk ranking.

He\'ll probably be covering more on the risk and

risk ranking, and the \"risk-based\" definition

will be covered a little later this morning in

Karen Ekelman\'s presentation. Anyhow. Barry?

\"RISK-BASED\" DEFINITION AND RISK RANKING

BY BARRY HOOBERMAN, Ph.D.

DR. HOOBERMAN: Okay. Thanks,

George. And since this is the first time a lot

of this will be presented, I\'m sure there\'s

going to be more than a few questions. Go

ahead. And, and that\'s part of the purpose of

this talk, is to try and set a background or a

framework for the whole risk assessment process

and trying to set it up for the breakout groups

that will happen later this afternoon to answer

a lot of your questions. So this is a brief

overview of what I\'m gonna try and talk about

today, and we\'ll try and answer these

questions: Why are we doing this? What about

risk? What is it? What\'s risk assessment and

risk ranking? And then: How are we going to

apply a risk-ranking approach to the Animal

Feed Safety System?

You\'ve heard of this before, but I

pointed out a few things in here that are

particularly interesting for this talk: to

develop and implement a comprehensive

risk-based preventive Animal Feed Safety System

that minimizes, reduces or eliminates the risk

to animal and human health. So we have already

heard a little bit about the comprehensive

aspects. I\'m gonna talk about the risk-based,

and part of the advantages of a risk-based

approach that we\'re using is that we\'ll cover a

preventative or preventive approach, and, of

course, the goal is to eliminate the risk to

both animal and human health.

So why a risk-based approach? I\'m a

firm believer in the first point, which is that

risk assessment provides a structure. It \--

All it is is a logical process for collecting,

organizing and analyzing information to inform

a risk decision. This is what often is

referred to as a sidespace decision-making. A

risk-assessment approach also can be used as a

forecasting process, and this is the prevention

\-- or the preventive approach we talked about

before: trying to prevent illnesses, predict

where illnesses, adverse health risks could

occur. And again, I think it provides a

structure to \-- for discussions between

decision-makers, stakeholders and the public so

everybody is on common ground and can have a

good discussion. Keep going.

So just to point out what risk

assessment is, everybody goes through this

every day. You\'re gonna ask yourself: Can I

cross the street safely? And just to point out

a few things, the \-- in this scenario, the cars

are the hazards that you want to avoid.

Exposure means when you walk out in the street,

you\'re gonna be exposing yourself to the

hazards, and, of course, there are consequences

if you don\'t do that properly, which \-- and

that is a tombstone down there. That\'s not to

say death is the only consequence.

So putting that in more of a

formatted approach, risk assessment poses four

simple questions: What can go wrong, and we

call that the hazard identification; what are

the consequences, which we call the consequence

assessment; how can it happen, which is the

exposure assessment; and then what is the

likelihood that what could go wrong does go

wrong, and that\'s where we put it all together

and try and come up with an estimate of risk.

And you can put that in an equation format.

Risk is a function \-- some function

of hazard and exposure. Again, the hazards

here we\'re talking about are the health

consequences, which are composed of two

components there: the severity of the health

consequences, which can be anything from slight

skin irritation to decreased feed consumption

in animals to death; and then there\'s also

something called potency, which is: How much

of, of the exposure to the hazardous substance

do you have to have in order to cause the

illness? And then the exposure side of the

equation just talks about: How, how are the

routes of exposure? How are you gonna be

exposed, and what\'s the likelihood that you are

gonna be exposed? And that can range anything

from improbable to common.

And, of course, risk assessment is

not the end of the story. Layered on top of

that is risk management. In other words,

somebody is gonna decide: What are we gonna do

about the risks that you\'ve talked about? Risk

management asks these kind of questions: What

can be done, what options are available, what

kind of risk trade-offs in terms of risk

benefits and costs, and what are the impacts of

current management decisions on future options?

Now, you can put that all together in what we

call risk analysis, and here\'s a brief sketch.

First, you define the problem, which is kind of

your hazard identification. You do your risk

assessment, and we \-- Being bureaucrats, we

have to write a report, so you write your risk

assessment report, which may outline a few

options for the risk managers to determine what

they want to do. The risk management makes

some decisions, and then the final aspect of

risk analysis is to communicate what those

risks are and what the risk management

decisions were to the \-- all interested

stakeholders.

And, of course, an important feature

is once you implement the risk management

decisions, it is iterate to process as more

data becomes available. You can repeat the

risk-assessment approach. In this case, they

installed a walk/do-not-walk sign, but

nevertheless, the person crossing the street

still has got to do some figuring out if they

can do that safely or not, and then you can

determine how effective that risk management

decision was, and if not, then you go back

through the cycle, and you come up with

something else, hopefully, that will reduce the

risk of being hit by a car.

So now we\'re talking about what risk

ranking is, so you can identify a bunch of

risks from individual hazards, and those are

represented by all the different circles. You

have different-sized risks. And then you go

through, and, and when you rank the risk, as

you see here, the \-- rank in terms of worst

risks on the top, the bigger circles, to the

lower risks.

And, of course, there\'s another

aspect to this. Should go \-- There we go.

Risk management is gonna weigh in, in the order

that the risk assessors may put things in, in

terms of lower to greater risks. When it comes

to actually doing something about it, the risk

managers may determine a different order,

depending on, on what kind of values they have,

cost-benefit analysis, those kind of things, so

the management order could be different than

the straight risk order.

Okay. Now we\'re gonna move into what

we want to talk about, which is the

risk-ranking procedure, and I just want to put

up this caution: That a lot of times you hear

about risk assessment, you hear a specific

risk, like one in a million or something like

that. We are not doing that. The risks that

we are ranking are relative risks, and that\'s

what we are concerned with, so nobody is gonna

say, The risk of this particular hazard, dioxin

or BSE in this particular feed, is one in a

hundred thousand. We are not doing that. All

we are talking about is relative risks.

So we\'ll go through the four steps

and the way we are going to implement them in

our risk-ranking procedure. Of course, the

first step is the hazard identification,

answering the question: What can go wrong?

What we\'ve tried to do is go by the guiding

principle on the bottom there, is we\'re trying

to make it as simple as possible, \'cause we\'re

realizing we\'re starting with the \-- with what

we\'re calling \"the universe of risk,\" and there

may be additional risks that become identified,

but at this point, we\'ve categorized the risks

into chemical, biological or physical hazards,

and then within those categories, we\'re

grouping them together to let us get a better

handle on things and not be bogged down by the

details of each specific risk, and then, of

course, within the groups, we\'re trying to

group further to talk about hazards with

similar characteristics. And the next slide

shows you kind of the approach we\'re taking.

We\'ve talked about the three

different types of categories: the intentional

\-- I\'m sorry \-- the physical, the

microbiological, the chemical. I\'ll also say

that we\'ve divided \'em up into unintentional

hazards and intentional hazards. Part of that

is \-- The intention, of course, is the

agroterrorism that has generated a lot of

publicity. And a lot of the identified risks

in there actually mirror what\'s in the

unintentional category.

Then \-- As I said, so we have the

three different types of risk in the un \-- I\'m

sorry \-- hazards in the unintentional category:

physical, microbiological and chemical. Then,

for instance, you can split out the

microbiological into different groups. You

have bacteria, viruses, fungi, (inaudible)

mycoplasma and others, and then within those

groups, on the next slide, you can kind of

group hazards into things with \-- hazards with

similar characteristic profiles, such as

salmonella, and realizing that they are not the

same but also realizing we are trying not to do

individual risk assessments on every single

hazard in every single feed. Okay. So that\'s

the first step.

Moving into the second step is, now

we\'re going to try and analyze: What are the

consequences of exposure to these hazards? So

the health-consequences step has two factors.

I mentioned that before. The first is

likelihood of the illness. If you\'re exposed

to the hazardous agent, how likely is it that

you will become ill? This was kind of the, the

potency argument \-- or statement that we talked

about before. It may be referred to as

\"potency\" of the hazardous agent, the amount of

hazard required to cause the illness or adverse

effect. The other component of health

consequences is the severity of the illness.

If you become ill, how severe is the illness?

Are you gonna die? Are you gonna \-- Is it just

gonna cause vomiting, or is it just gonna be a

light skin irritation?

And before we move further, I\'ll say

that we tried to put some of the background

slides in all of your packets, just generally

talking about the principles of risk

assessment. I happened to pick up a packet

today that did not have it, so if you don\'t

have it, don\'t worry. All the slides are avail

\-- will be available on the Website, I think,

from all the talks; right?

Okay. So the health-consequence

score, we said, was a combination of likelihood

and severity. You could combine \'em in this

type of approach, where a high severity \-- and,

and the colors are slightly off, that was

intended to be red in the upper square \-- goes

with a high likelihood, medium is not so much

of a concern as the high highs, and lows are

lower concern.

You can \-- Go to the next slide. You

can put it \-- How is this gonna look

numerically? We\'re gonna rank \-- give it a

health-consequence score from 1 to 5, and you

could say the 5s \-- We\'ve put a column of 5s on

the right \-- And this is just an example of how

we\'re \-- one approach to doing this. In this

approach, we\'re saying, Well, if it\'s gonna

cause a high severity or death, we\'re concerned

about it no matter if it\'s a low probability of

it happening or a medium probability of it

happening or, of course, a high probability.

We\'re gonna try and prevent deaths.

Then scores, if it\'s a \-- Well, you

can see the chart, but if it\'s a high

likelihood, even though it\'s a low or medium

severity, you can give it a 4, and then, of

course, going all the way down to the bottom,

if it\'s not very likely and it\'s a very low

health effect, it\'s of least concern, and it\'ll

get a score of 1. So the health-consequence

scores will be developed for both animals and

humans. We\'re concerned with both animal and

human health.

The scores for the chemical agents

may be based on existing health standards. I

mean, there\'s a lot of ADIs that have been

developed \-- that\'s acceptable to acceptable

daily intakes \-- that come from FDA. EPA has

something called RFDs, which are their

reference doses, which define a safe exposure

level or other kinds of health standards, and

there\'s a lot of those established already for

many of the chemical agents that we\'re

concerned with.

The scores for the physical agents

are likely to be higher for animals and humans.

In this case, you can almost look at animals as

kind of a filter for the physical agents. It\'s

never gonna make it to humans. I\'m talking

about rocks, glass. Those kind of things are

not gonna pass into the human food supply. Or

are unlikely to.

And then the scores for the

biological agents are a more difficult

challenge. There\'s a lot of work in trying to

figure out how much of an exposure to E. coli

is going to actually result in a health

consequence, and how severe is that health

consequence going to be? I mean, that\'s

something we\'re still working on, as are a lot

of people, not just us, but we will make a stab

at it.

Moving to the third step in risk

assessment: How could it happen? This is the

exposure assessment. This is a more difficult

challenge than the health-consequences score.

What we\'re trying to do here, the approach

we\'re taking is to identify the source of each

hazard entering the feed process. In other

words, starting at the very beginning of the \--

of the chain of manufacturing the feeds, what

are the potential hazards that are going to be

present, and at what levels? We\'re gonna work

through the chain by following the second

bullet point: Feed ingredients will be leaked

\-- linked to each hazard they may contain,

resulting in a set of ingredient hazard pairs

for each ingredients. In other words, we\'re

gonna worry about \-- From corn, we\'re gonna

worry about aflatoxin. From clay, one of the

hazards we\'re worried about is dioxin.

So for each one of these pairs, we\'re

gonna start out with the initial \-- trying to

figure out what the initial level of hazard is

and then feed ingredient or feed, and that\'s

gonna depend on a number of conditions:

environmental conditions, moisture content,

those kind of things; human activities, which

would work for pesticides and things like that;

the source and type of contaminant and the

source and type of feed ingredient. All those

will factor into what the initial level of the

hazard is in the feed ingredient.

So we\'re gonna give it an initial

exposure score based on what we think is there.

Most of the \-- We have \-- We don\'t have a lot

of data on these initial levels. We\'ll be

relying a lot on expert opinion and input from

knowledgeable sources, which may include you,

in trying to estimate that initial exposure

score. We do have data when available.

Measure data, salmonella contamination data, we

have some of that, but we\'ll rely on expert

opinion.

And then we also realized that, as it

goes through the feed manufacturing process,

things may change in terms of things that may

impact \-- The processing may impact the levels

of those hazards in the feed, so we\'re gonna

apply a modifying factor to that initial

exposure score. We\'re talking here things

like, if it\'s a high-heat process, you may

reduce or even eliminate the levels of the

bacterial contaminant, so we want to make sure

we incorporate that, so we would be reducing

that initial exposure score for that

contaminant \-- for bacterial contaminant in

that process. Manufacturing processes include

transportation, storage, steps and feed

manufacturing and on-farm processes.

And I\'ll apply one last thing. We

are gonna also \-- Remember our simplified

principle. We are gonna try and combine those

manufacturing processes into groups, as best we

can, that represent similar conditions of

processing.

So then you\'ll come up with a final

exposure score based on the initial exposure

score modified by \-- using modifying factors

from the manufacturing processes. And we

talked about the second example there, so next

slide.

So finally, you have the fourth step

in the risk assessment, which is estimating the

risk. What\'s the likelihood that you\'re gonna

have a sufficient hazard, in your final feed,

that\'s gonna pose a high risk? So the way

we\'re gonna get it is relative risk score.

Remember, we\'re only talking about relative

risk. As for each of the ingredient hazard

pairs we talked about, the consequence score,

which is the health-effects score, will be

multiplied by the exposure score to yield a

relative risk score, and it doesn\'t necessarily

have to be a multiplication. We are doing that

so we get a big spread of scores, so we get

differentiation between low risk and high risk.

You could possibly just add \'em, you could do a

number of other functions, but we\'re trying to

maximize the spread. For example, the

consequence scores and exposure scores may

range from 1 to 5, so when you multiply, you

have a range of relative scores from 1 to 25,

and hopefully, that will give us a good spread.

And then, of course, the interesting

factor is: How are we gonna use those relative

scores \-- risk scores? As you can see from the

list, these are some of the things we\'re

talking about. When you have a higher risk

contaminant, I mean, do we need to establish

limits for that? And in particular, which

contaminants do we need to establish limits

for? Do we need to develop analytical methods

for some of the higher-risk contaminants? If

we find common higher-risk contaminants in a

lot of feeds, perhaps we need to talk about

trying to change the manufacturing process so

that risks go down a little bit. And then, of

course, do we need to develop better

surveillance or sampling plans to ensure

compliance with existing contaminant limits or

ones that we may propose?

So just to summarize what we\'ve done,

we\'ve identified the hazards by grouping as

best we could. We come up with a consequence

assessment using the \-- a consequence score,

which is a function of severity and likelihood,

combination of those two factors. We\'ve tried

to come up with an exposure assessment by

starting with an initial exposure score that\'s

modified by factors in the manufacturing

process that may reduce or increase that

exposure to the hazardous agent and then

combining \'em together to come up with our

relative risk ranking.

Now, there\'s a lot of limitations to

this approach, and I\'m sure a lot of you have

already identified them, but I\'ll just go

through a couple that are obvious to us. You

could either take two approaches: You could

take a top-down or a bottom-up approach. A

top-down approach would say, for example, that

you start with an observed health effect, like

we know people are getting sick from a specific

contaminant, and we know the incidents of that

sickness. We could work our way from there \--

go through the feed supply to try and consider

the source, or you could also take it down a

notch, and you say you start with your final

feeds, and we know there\'s a high contaminant

level in a final feed, and we want to identify

the risk, work through \-- work \-- what\'s

causing that high-risk feed to occur.

So \-- One of the benefits of that

kind of approach is that it does focus on the

point of concern that\'s closest to what we\'re

worried about, is the health effect. The

problems with that approach is that we don\'t

have a lot of data to support it. We don\'t

have \-- And this is a credit to everybody, that

we don\'t have a lot of health effects from

animal feeds, and we don\'t have a lot of data

on potential hazards in final feeds. So that,

that really limits the usefulness of this kind

of approach, and this kind of approach also

would be difficult to use as a preventive tool,

which is, of course, one of our goals of the

Animal Feed Safety System. It\'s a hit or miss.

I mean, it\'s a one-shot deal. We\'re worried

about this specific hazard, and let\'s find it,

and \-- as opposed to a bottom-up approach,

which is one of the \-- we are \-- decided to

implement, where you start with the sources of

hazards, and you work through the system to

come up with your relative risk to health. The

benefits of this approach is that you do get to

incorporate the complexity of this system. It

also makes it more difficult to do, but it does

incorporate the complexity. It does permit

isolation of specific problems. If something

crops up, you can go back through everything

you\'ve laid out and figure out where that

problem could be \-- the source of that problem

could be, and therefore, it does allow a

preventive approach.

The problems is (sic) that it

requires a lot of risk assessment for each

hazard, and like I said, we\'re trying to group

the hazards, so we don\'t have to do that many,

but it is a more involved process, but that is

a function of the complexity of the whole

system.

Another limitation to using a

risk-ranking method and the one that we are

implementing, which is a \-- You can call it a

semiquantitative method, in that we\'re scaling

things on a factor of 1 to 5. This kind of

approach or methodology pushes most of the

insignments into the middle of the range.

You\'re gonna get a lot of things, we said, from

1 to 25. You\'re gonna end up with a lot of 9s

and 12s. A lot of things are gonna come out as

3s (sic) times 3 is 9 or 4 times 4 is 12 \-- 16,

in that middle range. So you don\'t have a lot

of distinguishment between intermediate risks.

For example, how do you handle kind of a

serious acute effect, like a severed finger,

versus a mild chronic effect, which is a

long-time health effect? They might come out

with a similar score, and that\'s something that

is a feature of this type of approach or a

negative aspect of this type of approach.

It also doesn\'t distinguish between a

high-exposure/low-consequence event versus a

low-exposure/high-consequence. The \-- When you

multiply \'em, those two things are gonna come

out the same. That\'s why we\'re working hard to

try and make sure we have a range and we can

differentiate between those kind of scenarios.

And then a final limitation is one

that\'s common to risk assessment, is data, or

lack of data. This is primarily an issue in

the exposure side of things. We don\'t have a

lot of measured data for many of the hazards,

so \-- which means we\'re gonna have a strong

reliance on expert opinion, not that there\'s

anything wrong with that. Expert opinion is a

form of data. It\'s just a matter of getting

quality expert opinion, people who really know.

I\'m not one of those people, but we have a lot

of people in CVM who are experts, and a lot of

people out there, I\'m sure, are experts and

will be able to weigh in on the process. So

that\'s an overview of our risk-ranking

approach.

DR. GRABER: We\'ve got some time

for questions for, for Barry. Can we get the

mike \-- Hold on one second.

DR. HOOBERMAN: Unfortunately, I

went too fast, leaving time for questions,

so . . . Sorry.

MS. WAGSTROM: Hi. I\'m Liz

Wagstrom of the National Pork Board. I have a

couple questions. One, in your hazard

identification, as you group and, and et

cetera, are you gonna look at risk by species

of animal fed? We know that there are risks in

feed of something that may be a risk to cattle

that may not be a risk when it\'s fed to pigs.

DR. HOOBERMAN: Yes. Yes. I

mean, it\'s not really in the hazard I.D. step.

Oh, I\'m sorry. Yes. It\'s not really in the

hazard I.D. step. It\'ll follow through the

chain to when we get to the final feeds in

ranking the relative risk of feeds. That, that

factor will come in. That \-- The hazards \--

MS. WAGSTROM: Thank you.

DR. HOOBERMAN: \-- that are not

there in the starting material will \-- of

course, will not be present in the final feed

for that species, so that\'s where that would

get incorporated.

MS. WAGSTROM: Okay.

DR. HOOBERMAN: Did that answer

your question?

MS. WAGSTROM: Somewhat,

although there may be a hazard there that isn\'t

a hazard for that species; i.e., we know that

E. coli 0157, there may be some evidence that

feed in cattle may, you know, be a problem in

herds that, you know, have contaminated feed.

E. coli 0157, while we don\'t want it in our pig

feed, has not been shown to be a hazard when

fed to pigs, so \--

DR. HOOBERMAN: Sure. And we\'re

not \-- Let\'s not confuse \"hazard\" and \"risk.\"

And just to go \--

MS. WAGSTROM: Okay.

DR. HOOBERMAN: \-- through this

again \--

MS. WAGSTROM: Sure. Okay.

DR. HOOBERMAN: \-- so the hazard

is E. coli, but the risk will be low because

the \--

MS. WAGSTROM: Sure. Okay.

DR. HOOBERMAN: \-- health

consequences in that species \--

MS. WAGSTROM: Gotcha. Okay.

DR. HOOBERMAN: \-- will be low,

so we\'ll work it through.

MS. WAGSTROM: Okay. Cool.

Second is, in your exposure assessment, am I

understanding that you\'re trying to link pairs;

i.e., corn and aflatoxin? Are you gonna take,

then, an average of aflatoxin found in corn,

realizing that the risk is the very small

percentage that may have high levels versus the

vast majority that may have low levels?

DR. HOOBERMAN: Yes. I mean,

that is a difficult approach that we\'re still

working on, is how to incorporate seasonality

and all those kind of factors into coming up

with that initial exposure score.

MS. WAGSTROM: Okay. And within

the exposure assessment, will you have any

distribution as \-- Will you look at your

manufacturing? There may be a lower risk for a

person with a 1- or 2-ton mixer feeding a small

group of animals versus feed and interstate

commerce. Will that be in your assessment, as

well?

DR. HOOBERMAN: We will try and

do that.

MS. WAGSTROM: Great. Thank

you.

DR. HOOBERMAN: (Inaudible) our

best efforts at that, yes, recognizing that it

could be a consideration.

MR. SHERWOOD: I\'m Greg Sherwood

with Aurora Cooperative Elevator Company at

Aurora, Nebraska. The question I have is the

use of the term \"contaminant.\" You talked

about \-- You\'ve used two terminologies already:

One was \"hazards\" in your feed, and the other

was \"contaminants\" in your feed, and the one of

the world organizations uses the term

\"adulterated feed,\" I think, and I\'m a little

bit curious to know \-- In a world that will sue

a company over a hot cup of coffee, I\'m a

little bit nervous about the use of

\"contaminant\" out there, especially in a

low-level environment. It looks to me, from a

feed manufacturer\'s standpoint, that we could

lose in court, when we didn\'t really lose, just

because somebody used the terminology

\"contaminants,\" when it was really an

adulterated feed or a foreign substance that

doesn\'t necessarily go through the feed to the

human.

DR. HOOBERMAN: I understand

what you\'re saying. I\'m gonna defer a little

bit to Karen, who will be talking about

contaminants specifically later this morning,

but that \-- I mean, it\'s a contaminant because

we don\'t want it there; right? That\'s a

definition of \"contaminant\"?

MR. SHERWOOD: So as a \-- Okay.

DR. HOOBERMAN: And, and \--

MR. SHERWOOD: Okay.

DR. HOOBERMAN: \-- there\'s a

reason we don\'t want it there.

MR. SHERWOOD: Okay. Oats \--

Let\'s see. Copper in sheep feed is a

contaminant; right?

DR. HOOBERMAN: Okay.

MR. SHERWOOD: It \-- The copper

in beef feed is not a contaminant, right \--

DR. HOOBERMAN: Right, at \--

MR. SHERWOOD: \-- at a certain

level?

DR. HOOBERMAN: Karen is talking

to me up front, so she\'s gonna be the best

person to respond to that question, \'cause she

will be talking later about contaminants; okay?

MR. SHERWOOD: Okay.

DR. HOOBERMAN: Thanks. One

more? Do we have time?

DR. GRABER: Oh, yeah. We got

two more.

DR. HOOBERMAN: Okay, two more.

MR. ROACH: Yes. My name is

Steve Roach. I\'m with Food Animal Concerns

Trust, and I was \-- just wanted to make a

comment about the way you described the risk

communication. In your \-- In your diagram, you

had \-- you all finished the job and then you

need to communicate the risk \--

DR. HOOBERMAN: Right.

MR. ROACH: \-- and in one of the

principles of risk assessment, is there

actually needs to be communication through the

risk-assessment period, you know, and \-- so

that you can have inpoll \-- input from state

polls \--

DR. HOOBERMAN: Yeah, I \--

MR. ROACH: \-- which is the

purpose of this (inaudible).

DR. HOOBERMAN: Well, there\'s a

lot of debate about the extent of that, but

you\'re absolutely right. I mean, it\'s always

good to get input, as you work your way through

the risk assessment, from all interested

parties. Absolutely correct.

MR. ROACH: And, I guess, in \--

sort of related to that is also \-- Again, you

mentioned a little bit about the lack of data

in the end, but that also needs to be

incorporated into the risk assessment, because

we \-- You \-- A lot of times the problem is, is

that we aren\'t able to characterize a risk very

well. That\'s really the challenge of risk

assessment. If we understood the risk

perfectly, then we would know exactly what to

do, and I think the \--

DR. HOOBERMAN: Right.

MR. ROACH: Again, a lot of

times risk assessment is described as a very

deterministic process, when, actually, you have

to decide all throughout based on the data you

have, and a lot of time you don\'t have it.

DR. HOOBERMAN: Yes, yes, you\'re

right. Although, we are doing the

semiquantitative. We\'re not going through the

full quantitative, where you can put

distributions on uncertainty and all those kind

of factors, but yes, we will recognize that,

and that\'s part of making your risk assessment

a transparent process, is pointing out those

kind of deficiencies in the data and where they

create uncertainty in your results. Any

others? Thank you.

DR. GRABER: Okay. We\'re gonna

take a half-hour break. Be back here at \--

sharply at 10:20, and we\'re gonna spend the

rest of the morning going through the

structural components.

(A break was taken from 9:50

a.m. to 10:20 a.m.)

DR. GRABER: The program is

Dennis McCurdy. Dr. McCurdy will be \-- is a

member of the Division of Animal Feeds, a

toxicologist/chemist. He\'s going to be

covering the first component, the safe feed

ingredient component. Dennis?

Oh, before I forget \-- What was I

gonna say? I forgot it already. Talk about a

senior moment. Oh, yeah. The \-- A number of

the packets did not have some of the slides

that Barry Hooberman used. We apologize for

that. We are making copies as you speak \-- as

I speak, and they will be available this

afternoon in the registration area. So for

those of you who do not have the slides \-- copy

of the slides \-- there was about 8 to 10 of

them \-- 8 to 10 slides \-- then just pick \'em up

this afternoon. Okay. Dennis?

SAFE FEED INGREDIENTS

BY JOHN D. McCURDY, Ph.D.

DR. McCURDY: Good morning.

Originally, George was programmed to put this

on, but he was deluged with a lot of thing \--

had a lot of things to do, so Karen Ekelman

sent me an e-mail suggesting that I would \-- I

should volunteer for this, and that reminds me

of a time back in 1968, where I said to

someone, I\'ll do this for you, and I spent some

time in a place that we don\'t want to go to, so

so much for volunteering.

But how many remember the Big Fat

Greek Wedding, which was on for \-- TV for a

while? And the father was always equating

words with derivatization from the \-- from the

Greek? Well, how many people are Irish, Irish

descent? I know at least one person here is

Irish descent. Anybody, anybody speak the old

language \-- study the old language? No. Well,

the Irish have been all over the world, as far

east as Japan, where you have the name Ohara

(phonetic). In Japanese, it means big belly,

\"O\" meaning big. But in the West, they came

even further west, and we have Omaha. Now,

the \-- Now, the \-- I broke my promise about

joke-telling. I\'m sorry. But the Omahas are

in the west part of Ireland. It\'s a variation

of \-- variation of a name.

Anyway, so that\'s me. Some people

call me \"John,\" some people call me \"Dennis,\"

some people call me \"Mack,\" you know. My wife

has a pet name, but we won\'t go there either.

As, as Dr. Graber stated and that,

that Shannon also stated, there are four

components in the framework, and the first

component that we\'re talking about, the agree

\-- and the approval process, and the approval

process for feeds is to be sure that everything

in the feed is safe, okay, for its intended

purpose. And, and feeds, as you \-- as you all

know, are not just a source of nutrition. I

mean, there are a lot of things that

(inaudible) feeds that come by way of color,

color additives, approved food additives,

things of tactical effect in \-- under approved

food additives, along with the grass substance

items. So we might find something in a feed

which may be an antioxidant or some kind of

preservative, mold inhibitor, that may be in

the feed. And, and so there are a lot of

organizations and processes that may have some

kind of an effect on feed and feed ingredients,

because the scope of the whole thing is to make

sure that all \-- that the safety applies to all

feed ingredients.

So we have the FDA, our lovely FDA,

in which the various components of the

Federal \-- the Federal Code addresses drugs,

food additives, color additives, grass

substances, bioengineering things, which are on

consultative agreements between the Center for

Food Safety and Applied Nutrition and CVM,

which are a biotechnology notification known as

a BNF file, and that works wonderfully well \--

has been working wonderfully well.

Other things going on in guidances

with FDA, things that are taken from

bioengineer plants and animals that are used as

drugs. We\'ll skip that, though. We\'ll come

down to USDA and EPA also affecting things that

may gone to (sic) \-- into animal feed and into

animals, vaccines for USDA; EPA, pesticides and

other things, such as water treatment

additives, that may find a way into animal

feed. And, of course, the AAFCO definition

process, we\'ll spend a little bit of time on

it.

But these former procedures by the

regulatory agencies are \-- and you can read

that \-- are \-- can be found in, in 21 CFR. For

those of you who don\'t know what 21 CFR looks

like, for our section, I have a copy. It\'s \--

This year, its copy is red, so it\'s our little

red book. You missed that one, huh? Okay. A

little side humor.

So those \-- You can find grass,

grass notifications and what have you in 570,

food additive petitions and its requirements in

571.1, and you can find them listed in 21 CFR

573\. So that\'s the way it works; okay?

For color additives, CVM does not

look at color additives. That\'s done through

the Color Additive Petition Group and CFSAN,

but that you find everything in 5 \-- in 21 CFR,

Part 73, and those \-- It has those listings

for, for, for food and drug color additives,

food, food color additives; okay? So \-- And as

a side note, if you\'re not well-versed on these

things, the, the individual Websites for EPA,

USDA and FDA are quite nice ways of spending

coffee break time. And then we have also our

informal, informal procedures, which result in

nonbinding decisions, and we\'ll go into that

part. Can we have the next slide, Abraham?

Since I am an individual to whom you

send data for review and evaluation, the AAFCO

definition process, which results in nonbinding

decisions on, on we, the FDA, are placed in the

official publication, and I have a copy of the

OP if you want to see some of the things that

we\'ve done and what\'s required. Has included

\-- Does include a lot of things that are not \--

or do not have a written regulation, which

would be a food additive petition. Food

additive petition would have to be submitted to

the agency, or grass petition have to be

submitted to the agency. We would go ahead,

and we would do a formal review and evaluation

of manufacturing data and safety data and other

things that may have to be done and go ahead

and publish a regulation. The AAFCO definition

process does not result in a formal regulation

published in the \-- in the Federal \-- in Title

21 of the Federal Code. It will be in the

official publication of the AAFCO. Can I have

the next slide, Abraham?

Okay. So that leads to a major \-- a

major gap. That \-- Not the only one

identified \-- or could be identified, but it\'s

the one that we have identified, because we

work so closely \-- at least our shop does \--

work so closely with, with AAFCO in preparation

and defining of some of these feed-additive

ingredients.

The difference between the AAFCO

definition process and a full formal FAP, or

food additive petition process, is one in, in

\-- in \-- one in which we ask for similar kinds

of data, but the review process is one in which

we have relative \-- relatively little safety

concern about the material that\'s being added,

added to the feed; okay? If, in the process,

we do discover situations or an issue where

it\'s of, of, of safety concern, then, then, of

course, the next \-- the next move would be for

a food additive petition, \'cause we wouldn\'t

go \-- we wouldn\'t go this route, but we\'ve been

very successful with this route over, over the

number of \-- over a number of years.

The \-- What happens here is, though,

the AAFCO is not the title \-- not Title 21 of

the Federal Code, so there is no federal

regulation published \-- written or published;

okay? It only \-- It only appears in the OP,

but when we go to look at writing an Animal

Feed Safety System as a formal title

regulation, then these \-- then this bounce \--

this bounces up to each other.

So what we need to do and are

planning to do is to go ahead and clarify, in a

compliance policy guide, as to this

relationship and this situation, and it has

even, even a reference that maybe a regulation

should be published, but then again, there may

be a legal conundrum there, too, so . . .

That\'s, that\'s the one, one gap we\'ll \-- that

we\'ve identified. I spend most of my time as a

regulatory toxicologist and regulatory

chemist \-- chemist first, toxicologist

second \-- on evaluating these kinds of data,

and in the recent time, I\'m spending a lot of

time on enzymes.

So there \-- There\'s sort of a

bounce-up for these things in the OP, which, in

tactical, are not really recognized by the

Federal Food, Drug and Cosmetic Act because

there is \-- there is no publication written.

There is no regulation published \-- written and

published in the Title 21 CFR 573.

Is that the last one, Abraham? Yeah,

that\'s it. So that\'s, that\'s the, the, the

first component that we\'re looking at, at these

processes and these ingredients and, and the

non \-- non-FDA-binding materials that are \--

and chemicals that are \-- find their way

through the AAFCO official publication

definition process. Got a question? Yeah,

Ally (phonetic)?

MALE VOICE: (Inaudible) \--

DR. GRABER: Whoa, whoa, whoa.

Wait.

MALE VOICE: I\'m sorry. Oh. I

just wanted to mention that \-- or if you have

any comments, that ingredients definitions that

are proposed to AAFCO also are reviewed by FDA.

I think that\'s part of the process of the

ingredients definition, that we make sure that

that goes to FDA and FDA has a chance to review

and make comments.

DR. McCURDY: Yes. And, and

many times there\'s been some spirited

discussion at the, the ingredient definition

process at the AAF \-- at AAFCO, so \-- But that

has work \-- That has worked quite well in the

past number of years.

Just one other \-- One other thing

just popped in my head. Okay. It does \-- It

does work. Here\'s an example of how it does

work; okay? A number of years ago I was on

a \-- I was the primary viewer for toiliwell

(phonetic), okay, to be used in animal feed as

a source of linoleic and linoleic acids.

Someone wasn\'t playing cricket. We asked AAFCO

to have that definition withdrawn. That

definition was withdrawn. Toiliwell is not

supposed to be on \-- to be used for an animal

feed. That did not require a notice of

federal \-- What do you call it?

(Inaudible.)

DR. McCURDY: Yeah. Yeah. So

it was done (snaps) in a heartbeat, as opposed

to going through a legal action. So it, it

works well.

DR. GRABER: Okay. In a

heartbeat. Okay. Karen \--

MALE VOICE: (Inaudible.)

DR. GRABER: Okay. Next, next

on the program is Karen Ekelman, who is a team

leader for the Animal Feed Safety Team in the

Division of Animal Feeds. She is gonna be

covering limits for animal feed contaminants

and also \"risk-based\" definition.

LIMITS FOR ANIMAL FEED CONTAMINANTS

BY KAREN EKELMAN, Ph.D.

DR. EKELMAN: Thank you, George.

I asked George to wave at me at 12 minutes, but

if I don\'t notice it, the rest of you are free

to wave at me at 15; all right? Get me off the

stand here.

I want to talk by trying to \-- start

to talk by trying to address some of the

definitions that were raised earlier. Somebody

asked, Well, what\'s adulterated? What\'s a

contaminant? What do you mean by these terms

you\'re using? In general, we\'re not trying to

use legal terms here, but we\'re using

\"contaminant\" to mean anything that\'s in the

animal feed that you didn\'t want to be in that

feed or didn\'t intend to be in that feed. It

could be a nonhazardous contaminant. For

instance, if you want to put rye in, and there

are other grasses mixed with them, those could

be contaminants, if you think you\'re buying rye

and you get something you don\'t want. Those

are unlikely to be hazardous contaminants. So

a contaminant is anything you don\'t want there.

A hazardous contaminant is something that might

present a hazard if it is there, and those are

what we\'re working on for our risk-based

assessment.

Again, you might think that the risk

assessment only applies to hazardous

contaminants, but some of the questions that

were raised were very perceptive. Somebody was

talking about copper for sheep and goats. And

so what Dennis McCurdy talked about, which is

our approved feed ingredients, they can also

present hazards for certain species for which

they are not approved or for species that are

more sensitive than others. So the

risk-ranking procedure is not only for some

contaminants that we consider to be potentially

hazardous but also for feed ingredients that

may be hazardous when used in ways in which

they were not intended or approved. I just

wanted to make that clarification.

Today I\'m going to talk about

Component 2 of the Animal Feed Safety System,

and if you\'re following along on your component

there, it starts on page 3, and it\'s limits for

animal feed contaminants. We chose the word

\"limits\" very carefully because there are a

number of mechanisms FDA and other

organizations can use to recommend what safe

limits would be, and we didn\'t want to imply

that we had thought ahead of time about what we

might use. So I\'m gonna briefly discuss the

objective and scope of this particular

component, the three gaps that were identified,

and then I\'m going to switch a little bit and

talk about what, what contaminants are you

talking about in terms of hazardous or

potentially hazardous contaminants. If you

remember, Barry said that we\'d come up with 175

or so, and I\'m sure, when you take a look at

that list \-- and you will get a chance to when

we finalize it, and you will agree with most of

the things that were on our starter list, and

again, for what purpose we\'re doing this. Then

I\'m going to discuss a modification to the

definition of \"risk base\" that we first made

available in 2004, and I\'m gonna summarize some

of the comments we\'ve received on risk issues,

focusing on those ones that might be

interesting to discuss in your breakout groups

this afternoon. Next, please.

The objective of Component 2 states

to use risk-based mechanisms to identify and

develop limits for potentially hazardous

contaminants in animal feed and feed

ingredients. That\'s pretty straightforward.

And we see from harvesting through use of \--

through feeding, we need to consider the entire

continuum. Next, please. Abraham, next

please.

Component 2 does not \-- Oh, go back

one. I\'m sorry. It looked the same to me, but

it was different.

The scope is, contaminants are toxic

or deleterious biological, chemical or physical

hazards that are inadvertently present in

animal feed and feed ingredients, and I just

have some pictures here. There\'s a whole bin

of USDA-condemned poultry, and you wonder where

they\'re gonna go, and there\'s a flooded field,

and you wonder what\'s gonna happen with the

crops in those fields if they\'re destined for

human or animal consumption, and all of those

are potential sources of hazards you need to

think about. Next, please.

Component 2 does not \-- or does apply

to contaminants that may be inadvertently added

to animal feed during its manufacture. The big

example is the dioxins that are created by

heating a set of substances to a certain

temperature, and we did have one episode of

those recently. However, Component 2 does not

apply to unapproved or prohibited feed

ingredients \-- that\'s under Component 1 \-- and

it also does not apply to expected contaminants

in approved feed ingredients that are likely to

be residues of starting materials or breakdown

products produced during manufacture, and

that\'s because the way in which these feed

ingredients are approved includes review of

manufacturing processes and potential

contaminants, and usually, specifications will

be set if there are contaminants or breakdown

products in the manufacture of a feed

ingredient that raise a \-- either an identity

concern or a safety concern, so these are not

covered under what we\'re talking about under

Component 2. Instead, they belong in

Component 1. Next.

Three gaps were identified for

Component 2. The first is that risk ranking

will be used to help determine which

contaminants present the greatest risk to

animals and humans and to help decide how best

to prevent, eliminate or control those risks.

And the comments \-- I summarized the comments,

so if you made a comment and don\'t recognize it

verbatim here, I, I summarized a number of

them, but they were generally about the

risk-ranking process, and they cautioned us

that they should be done only for segments of

the feed industry that are not now controlled

by CGMPs and to specify the process steps

associated with risk, and, and those are all

good points and points we need to take to

heart. Next, please.

Gap 2 is the validated test methods

for some feed contaminants may need to be

developed (sic). It\'s a lot longer in your gap

statement, but I tried to summarize it. Now,

everyone knows if we come up with 10

contaminants or 20 contaminants, that somebody

needs to control in feed under certain

circumstances, that there are unlikely to be

validated test methods for all of those in the

particular feeds. It\'s also unlikely that FDA

is going to have the resources to develop

validated test methods for all high-risk

contaminants, so this is a joint process.

The agency has had experience with

setting criteria for test validation that may

be done by third parties. In addition, we

finally do \-- and this is the first

announcement of this \-- have a new resource

available to us. Dennis McCurdy, who is on the

Animal Feed Safety System Team, is going to be

working with some individuals in our research

group who have been given a little bit of

bioterrorism money, and they are going to be

working on developing some test methods for

some hazardous contaminants in animal feed. We

don\'t know how, how far they\'ll get or what

they\'ll be able to do, but this is the first

indication we\'ve had that we may be able to

have some resources devoted to this area, and

so input from individuals about what they think

we should be working on would be useful at this

point. Comments for this were that we need to

recognize that rapid, inexpensive and reliable

test kits for most of these contaminants are

not going to be available or, if available, are

not validated, and that\'s a very legitimate

concern. Next, please.

Gap 3 relates to agroterrorism. It

says, By ranking the risk of potential

agroterrorist agents that can be added to

animal feed, we will enhance our ability to

work with USDA to improve methods of

preventing, coordinating responses to and

investigating terrorist incidents involving the

deliberate contamination of feed ingredients

with exotic animal diseases.

I don\'t know how many of you read

your newspaper today that was delivered to your

door, but there was an article on an exercise

going on right now that involves CVM and the

rest of FDA and a number of states, in which

there was potential \-- it\'s not real, it\'s,

it\'s \-- a potential release of a hazardous

infectious agent from a car in New Jersey, and

we were alerted that we were going to be

involved in an exercise, but, of course, we

didn\'t know what it was. So a number of people

back at CVM now are working on their responses

to this, and we consider this to be an

important part of what we\'re doing, but, of

course, we recognize that we can\'t rank the

risk of potential agroterrorist agents the way

we would for normal agents because we don\'t

have exposure levels, so we\'re having to be

fairly creative about that. And we had one

commenter that agreed that this would be good

to deal with this issue in the AF \-- Animal

Feed Safety System in some way. Next, please.

I just wanted to include some

examples of, of some of the contaminants that

we are developing risk-ranking score fors

(sic). There\'s salmonella, E. coli,

staphylococcus and clostridia. Also, there are

different \-- We have identified not only

salmonella but the specific subsets of

salmonella that we consider important; insects,

such as the blister beetle, and I bring that up

because possibility of contamination with a

blister beetle is one of the things that was

considered and what George mentioned was the

recent outbreak of horse deaths in Puerto Rico

that we could not identify the source of; and

the transmissible spongiform encephalopathy,

such as BSE and CWE \-- D are also going to be

ranked. Next, please.

Chemicals, drugs approved for use in

animal feed. Again, we will not set new limits

on these drugs, but we will simply consider

which drugs are most likely to be present at

excess levels, based on our data, in what feeds

and for what animals this is likely to be a

problem and see if we need to have additional

controls in place. Mycotoxins, such as

aflatoxin and fumonisin; environmental

contaminants, such as pesticides, dioxins,

PCPs, radionuclides and heavy metals; and, of

course, the physical examples \-- bone, glass,

metal and plastic \-- will likely pose risk to

animals but not likely to pose risk to humans

consuming the animals.

And you\'ve seen some of these before,

but we thought it would be a good idea to

mention them again. What are we doing this

risk ranking for in relation to feed

contaminants? We want to determine which feed

contaminants are present, that present the

highest risk, and decide how best we can

eliminate, prevent or control those risks.

Next, please.

Now, I don\'t know if you recall \--

And for many of you there should be available,

in your folder, a \-- one sheet that has the old

\"risk\" definition on top and then \-- \-- and a

new one on the bottom, and note that we are

defining \"risk-based\" and not \"risk.\" In other

words, we\'re defining what \"risk\" means to us

in the Animal Feed Safety System, but the

second sentence attempted to find \"risk\" in a

way that was understandable to people, and that

was the one that caused the most concern.

So the entire definition is on your

sheet, and if you don\'t have one, we\'ll make

one available before the breakout groups, but

that definition was \-- said risk is a function

of the likelihood of human or animal exposure

to deleterious amounts of such hazards in feeds

and the significance of the health consequences

in response to those exposures. Next, please.

The comments we received are \-- We

should be a little more specific in what we\'re

talking about. What about nonregulatory

approaches? And I\'m not gonna discuss that,

but non \-- Regulatory approaches includes a

huge range of approaches, including education,

and I think we\'ll talk about that when we talk

about Component 4 today, but we also had the

comment, comment several times \-- the

definition unclear \-- what does risk as a

function really mean in lay terms? And so we

simply altered that part of our definition.

Next page.

And we hope this under \-- The risk

resulting from the presence of these hazards in

feeds is some combination of the likelihood of

the human and animal exposure to the feed

hazard and the significance of the health

consequences, and I think Barry explained quite

well that we\'re going to modify these two

scores, but you could do other things. You

could add them. You could treat them in some

other way. And, and it basically gets to:

What do you want to do with the scores? And we

want to spread them out so that we can make

risk decisions, and multiplying is one way to

do that. So that\'s just what we tried to

correct, and you can look in your folder for

the complete definition. The rest of the

definition \-- I think there\'s one minor point

that\'s changed, but the rest remains relatively

the same. Next, please.

And finally, these are some of the

interesting comments we received on risk and

risk ranking that you might want to consider as

you go to your breakout groups. First, how

would a risk-based approach affect some states\'

focus on consumer protection, which is also

called economic protection? And George

mentioned this, in his introductory talk, as

something that would be interesting to

consider.

Also, people told us, as if we didn\'t

know, that risk ranking would be difficult,

time-consuming, expensive and hampered by

insufficient data. Absolutely correct. It

will be all those things. And the best way we

can think of to make it work anyway is to make

all the stages in that process visible to both

the people at FDA and to the public, and so

that way, we hope you will help us get the data

we need to modify some of these assumptions

we\'re gonna have to use.

Risk ranking will result in a

requirement that feed manufacturers test for

more contaminants, so I can actually say that

we don\'t have any clue, at this point, whether

that\'s gonna be true or not. Could be; could

not be. We just aren\'t at that point.

And various comments differed about

whether risk ranking should focus on human risk

only or should focus on risk to humans and

animals, and that\'s something we\'re going to

have to address in a political, as well as a

regulatory arena, when we get to the end of

this, but at this point, we\'re committed to our

focus on animals and human risk.

Do you like my chicken picture?

That\'s the end, and \-- Thank you.

DR. GRABER: Okay. We\'ll take

one question or comment, or \-- if anybody has

one. We have one.

MR. SHERWOOD: I\'m Greg

Sherwood, again, with Aurora Cooperative. In

the feed industry, the only thing \-- or one of

the things that we think we can be accountable

for is that a feed that we produce goes to

animal, if there\'s a disease and it can be

expressed in the meat, and how does that get

passed into the human food chain? And because

of that, there\'s two samples you have under

your biological: One of \'em is salmonella, and

I believe that the cereal types found in the

salmonella and animal feed are different than

those that are found in the human, to cause a

sickness in human, and, and the other one is

E. coli. I don\'t believe there\'s any data out

there that shows that E. coli in the feed will

be expressed in the meat. It\'s more of a

cleanliness issue of whether the hands of the

handler were clean or whether it got ground

inside the beef or whether it\'s on your lettuce

salad or, or \-- And the issue of the largest

E. coli outbreak in the United States was in a

swimming pool in Atlanta, Georgia, not \--

having nothing to do with feed. And because

there is no scientific proof that it is

expressed inside the meat, I guess I would ask

that those two be taken off of the biological

list, because it scares the heck out of the

public \--

DR. EKELMAN: Okay.

MR. SHERWOOD: \-- and it may not

be factual.

DR. EKELMAN: Okay. What I want

to emphasize is the list of hazards is not a

list of risks. The list of hazards is sitting

down and saying to people \-- experts in the

field: What do you think might be in feed that

you are concerned might cause a risk to animals

and humans? When we develop our list to risk,

we might conclude that some of those are highly

unlikely to be in feed and, thus, highly

unlikely to pose a problem, and they would

naturally fall out of our assessment. That\'s

No. 1. The second one is, we\'re aware of the

fact that while there\'s \-- there is difference

in salmonella that have been identified in

animals, in feed and in humans \-- and that

data \-- those data are very important, but we

don\'t consider them conclusive at this point.

You know, we could talk about it, but probably,

this isn\'t the right forum. And E. coli

0157:H7 continues to be a problem. Even if

it\'s present in animals at the time that

they\'re slaughtered, that would be a potential

for contamination in passing to humans.

So we hope to evaluate the risk of

those with data available and assumptions and

modify them as time goes on, but we want you to

remember, we started with a list of \-- a long

list of hazards, and they may not all be on our

list of risks when we\'re done.

DR. GRABER: Okay. Next on the

program is Mr. Paul Bachman with the Center for

Veterinary Medicine, Division of Compliance,

and he\'ll be talking about process control for

production of feed. Paul?

PROCESS CONTROL FOR THE PRODUCTION OF FEED

BY PAUL BACHMAN

MR. BACHMAN: Thank you,

George. My name is not synonymous with process

control, although it seems to keep following me

around. But I appreciate being here today, and

now I know where I\'m at. I\'m in Omaha,

something like that, and thank you, Dennis, for

reminding me and that I have a responsibility

this morning. Next slide, please.

We\'re just going to do a brief

overview of the process control component,

which you can find in your packet, as well as

what\'s been published prior to this meeting,

and the objective of the process control is to

ensure the safe manufacture, packing, storage,

distribution or use of all feed ingredients and

mixed feed. The scope is \-- As you can see, it

applies to firms and individuals involved in

the manufacturing, package, storage,

distribution and use of feed ingredients in

mixed feed, including on-farm operations.

Next.

So somebody asked the question:

Well, why process control, or what are we \--

what are we trying to accomplish? And

basically, what we\'re trying to accomplish,

which is \-- several other people have already

mentioned this morning \-- it\'s a preventative

measure to eliminate or reduce to an acceptable

level risk to animals and humans that might

occur during the processing of feed ingredients

and mixed feed. What is process control?

We\'re viewing it, at this time, as a systematic

approach designed to ensure feed safety. Next.

And how are we proposing to go about

that? And it\'s by identification and use of

appropriate controls, within an established

feed safety program, to prevent, eliminate or

reduce to an acceptable level, again, risk to

animals and humans and, by establishing

procedures, to verify that the controls

established within the feed safety program are

effective. Next.

So the question is: How do we design

this systematic approach? And when I mean \"we\"

\-- Or what I refer to as \"we\" is the public

comments sought, and as Dr. McChesney indicated

this morning, what Dr. Sundlof had indicated at

the first public meeting, is that your input

during the breakout sessions and following the

breakout sessions, with written comments, is

very critical to what we have defined to date

and what direction the process may take in the

future. So it\'s very critical that you, you

become active in your breakout groups today and

tomorrow.

This is just a list of some of the

approaches that FDA has used in the past or

utilized in the past. As, as \-- Some of you

are quite familiar with the good \-- current

good manufacturing practice of Type A medicated

articles and medicated feeds, and also, GMPs

apply and low-acid canned food or hazard

analysis and critical control point programs

for seafood and juice, and, of course, seafood

and juice also have some sanitary standard

operating procedures involved.

But I do want to say, at this time,

that we, meaning the Animal Feed Safety System

Team, are not advocating any of these

approaches for this issue. It \-- Keep an open

mind. Again, as Dan said this morning, try to

keep an open mind. Think outside the box. And

we are not in a position, as the previous slide

indicated, to indicate any of those particular

forms of approach.

Within process control, the team has

identified only one gap at this time, and

that\'s, basically, that there\'s no current

regulatory approach to govern controls used to

address feed safety. Concerns associated with

manufacturing, package, storage, distribution

and use of nonmedicated feed, ingredients and

mixed feed.

We have received several comments to

the docket to this point. Some of these are

rather recent comments, which were received

after publication \-- notice of publication of

this public meeting. One comment indicated

that the unidentified gap is not correct. The

gap is focused solely on the medicated feed

industry, and in no way was this our intent.

Like I said on a previous slide, this goes

beyond existing in our current medicated feed

industry, and, you know, what we\'re trying

to \-- trying to work on here, the issue is much

larger and beyond the scope of existing GMPs

for medicated feed.

Another comment indicated it was very

important for the agency to extend feed safety

programs up and down the stream from commercial

feed manufacturers, now, indicating this needs

to apply to feed ingredient suppliers and

animal feeders. If we have not made that point

clear prior, we apologize, but again, it is our

intent \-- and I think Shannon discussed this

this morning in his presentation, as well as

other people, that, again, this is a

broad-scope-type approach. Next, please.

We\'ve also had a comment indicating

the identified gap contradicts the concept of

flexibility embodied in one of the core

concepts contained in FDA\'s draft definition of

comprehensive. Next.

The comment went on to specify that

the fourth component of the definition, as, as

Shannon discussed this morning, the flexibility

be process- or product-oriented, depending on

the situation; okay? And as Shannon indicated,

we need a little bit more discussion or comment

as to: What do you really mean when you say a

process control program should take the \-- be

oriented towards product control or vice versa?

And just put this in here for

something to think about. You may want to

discuss it in some of the appropriate groups \--

of applicable groups. And then: What does

process- or product-oriented mean to you within

the context of the identified gap for Component

No. 3, process control? Okay. Next.

Also published in March of 2004 was

the paper of basic elements of the Animal Feed

Safety System process control. These elements

are also in your packet. There\'s a \-- I think,

a single page or two pages on the elements.

Again, these are some things for you to think

about. Let\'s see if they\'re comprehensive

enough, and we\'ll see what maybe should be

added or, or make some comments about it. But

basically, you know, the process \-- The \--

Basically, the elements group identified seven

elements, with, as indicated, the subelements

for \-- a number of subelements for each one of

these. I won\'t go down through the seven. I

think you can see \'em, and they\'re also in your

packets, so that should be sufficient to

review. Next, please. Next. Back up one.

I\'m sorry. I forgot to cover something.

And just to point out that each of

the saloma \-- sal \-- salamander, salamental

(phonetic), salmonella \-- seven elements \-- The

final subelement listed was indication for

written SOPs; okay? Next, please.

Speaking of the master of senior

moments, during the break, I went up to my room

to get a copy of my presentation. Well, it was

about 30 seconds before Dennis started speaking

that I realized that I didn\'t have it, you

know, so I don\'t know what I \-- I\'m not exactly

sure what took place in my room or the trip up

and back, but \-- you know.

Some comments to the document \-- Most

of the comments were specific to each

subelement of an element; however, there\'s one

repeating comment specific to the indication

for written SOPs. I think that it needs

mentioned here for your further consideration.

Next, please.

Written SOPs should be dependent upon

type, size, complexity of the operation or

number of personnel involved. Now, this is a

comment we received, okay. The second \--

Another one of the comments specific to the

elements were that SOPs are advisable in most

cases but may be inappropriate for extremely

small commercial or on-farm establishments

where one or two persons are responsible for

manufacturing or feeding of products. Next,

please.

Again, just something to think about,

and you may want to comment on this, \'cause I

think we\'re looking for additional information.

In a risk-based approach for human and animal

feed safety, how are risks dependent upon the

type, size, complexity of the operation or

number of personnel involved? And so if there

can be a little more detailed explanation of

how some people think that that \-- You know,

there\'s an implicit property in there somewhere

that we\'re still not viewing. We could use

that. And that\'s the end.

As you see, not everything is clearly

focused. We\'re seeking input. There\'s a lot

of variability, and \-- This is a joke; okay? I

have to say this is a joke, all right, because

this came with a caption that said \-- And this

is sort of relative. \"Relative\" in the sense

that the hen is related to the chick; okay?

That type of relative, in a sense. The caption

said, What happens when you feed Fruit Loops to

chi \-- to hens; okay? FDA is not saying this.

It\'s not what happens, I don\'t think, you know.

Maybe some of you poultry people know better,

but I\'ve seen green eggs and brown eggs and

white eggs in a previous life, but \-- I don\'t

know, you know.

Happy Easter \-- belated Easter.

Thank you.

DR. GRABER: We\'re really out of

time, but we\'ll take one question, if someone

has it.

Okay. All right. We \-- Since Paul

is having a senior moment, we\'re gonna \-- we\'re

gonna do Groundhog Day. The next speaker will

be Paul Bachman to talk about \-- No. See if he

can get it right this time. Okay. Never mind.

Next on the program \-- Before I

forget, the \-- For those of you who do not have

the slides \-- some of Barry Hooberman\'s slides

and the definition of \"risk-based,\" the

one-pager that\'s supposed to have been in your

book, they\'re now in the back of the room, so

at the end of the day \-- or at the end of the

morning, you can pick them up. They\'re on the

table at the back of the room.

Okay. Now for the fourth component,

we have Dr. Steve Traylor with the University

of Kentucky\'s Division of Regulatory Services.

I\'m sorry, Steve, for the error in the \-- in

the agenda. It\'s Division of Regulatory

Services. And he\'s gonna talk about regulatory

oversight. Steve?

REGULATORY OVERSIGHT

BY STEVE TRAYLOR, Ph.D.

DR. TRAYLOR: Thank you,

Dr. Graber. As a state representative on this

committee, it is indeed my pleasure to present

the next component of the Animal Feed Safety

System entitled \"Regulatory Oversight.\"

Current regulatory oversight is present in

levels commensurate with risk to the animals

and humans through inspection enforcement

activities. Thus, the objective of Component 4

is to develop a framework for the use of

prioritizing and allocating inspection

enforcement resources to minimize risk to

animal and human health.

Although the Animal Feed Safety

System is an umbrella program being developed

by FDA, it is essential for us to consider the

impact that this program will have on other

regulatory agencies. This is especially true

when one views the impact of such a program on

the relationship between FDA and the other

regulatory agencies, including the states.

With this in mind, the scope for this component

was designed such that the process should apply

to FDA\'s feed regulatory activities from the

similar state acts as conducted using the FDA

authority. Examples of this would include

label review, education, inspections,

enforcement and information sharing.

The next four slides will, will cover

the subpart of Component 4, which is the

inspection program, and the inspection program

is utilized, thus far, by regulatory agencies

to determine a firm\'s or product\'s degree of

compliance with applicable regulations, include

(sic) surveillance-based inspections or

compliance-based inspections. Surveillance

inspections are conducted to determine whether

a firm is substantially in compliance with the

regulations and are operating under control.

In contrast, compliance-based inspections are

conducted to evaluate a firm\'s compliance with

the provisions of the regulations and to

document the inspectional observations

supporting possible enforcement action. An

example of this type of inspection would be a

for-cause inspection, and one on the

surveillance inspections would be a GMP- or

BSE-based inspection.

In Dr. Graber\'s talk earlier this

morning, he stated that one of the operating

principles of the \-- of this system includes a

robust federal and state relationship covering

all aspects of feed regulation. It is

difficult to discuss inspection programs

without noting the integral relationship and

involvement and interaction between FDA and

their state counterparts. This is because a

large majority of the inspections are indeed

conducted by FDA state counterparts.

Therefore, a strong working relationship should

be a significant component of the Animal Feed

Safety System. Of particular interest to the

states\' regulatory agencies is that under the

proposed regulation \-- or the proposed Animal

Feed Safety System Program, their role in

inspection and enforcement, under their laws

and regulations, should not change.

As an extension of what was discussed

earlier today in Component 2, the regulatory

oversight component would utilize a risk-based

approach to improve the agency\'s ability to

prioritize and allocate inspection resources by

targeting firms, facilities, products and

processes that have been identified as posing

the greatest risk to animal and human health.

Going into the second subpart of

Component 4, which is enforcement, FDA has a

variety of enforcement options that are indeed

available to them. Regulatory enforcement

often focuses on voluntary compliance with the

law and regulations; however, when voluntary

compliance and education are successful, the

agency must use a variety of enforcement

options that are at their discretion. These

would include warning letters, untitled

letters, criminal penalties, withdraw from

distribution orders, et cetera.

Moving into the identified gap

section, there were three gaps identified, with

Gap 1 being establishing priorities, Gap 2

encompassed on-farm manufacturing in the

transportation sector, and the third gap

identified was inspector training. To discuss

each one of those gaps in detail in the current

regulatory oversight program, the agencies have

established priorities for inspections under

BSE inspection program based on a combination

of risks.

In \-- Most of us are probably not

aware of the next point, but CVM is currently

developing a risk-based inspection approach for

other feed-related inspections, and this is not

expected to be completed until FY 2006. To

discuss this just a little bit further, a

committee within CVM was charged, in 2004, of

developing a risk-based method for determining

the feed products, processes and/or facilities

that presented the greatest risk to animal and

human health. In CDER, the Center for Disease

(sic) Evaluation and Research, has just

developed their risk-based model for

prioritizing GMP drug inspections that occurred

in September of 2004.

It\'s important to note that a member

of the Animal Feed Safety System, Abraham

Kamara (phonetic), is also one of the

individuals working on CVM\'s risk-based

inspection system, and he works to ensure that

CVM\'s risk-based inspection approach for

inspector \-- for inspections will be the same

or similar to the Animal Feed Safety System

risk-based approach.

For the eight major compliance

programs that\'s gonna be encompassed in that

system for CVM, it includes drug preapproval

inspections; drug GMP inspections; drug

post-approval inspections; the medicated CGMP

inspections; the BIMO, or the bioengineered

inspection and monitoring inspections; BSE feed

contaminants; and residues for drugs,

pesticides and tissues. I mean dioxin.

Identified Gap No. 2, Subpart A, again, was the

on-farm component.

As of today, regulatory oversight is

focused principally on the commercial-medicated

feed industry, even though there has been a

major shift to on-farm production of feed. In

fact, a lot of the on-farm integrated, if you

will, operations produce a lot more feed in

their facilities than do most commercial

manufacturers.

The Animal Feed Safety System Team is

developing a more comprehensive regulatory

approach that will cover all aspects of the

animal-feeding industry, including

transporters, mixer feeders and livestock

producers. Next.

Subpart 2, where \-- identified Gap 2,

Part B, and \-- is the transportation component.

Part of the recent GAO report issued on the BSE

identified the transportation sector as being a

major area of concern. The Animal Feed Safety

System Team would indeed like your thoughts and

ideas on how to deal with this potential

cross-contamination issue.

Recently \-- it was in December of

2004 \-- the Department of Transportation Act of

1990, there was a notice of proposed

rule-making published, which dealt with the \--

safeguarding food from contamination during

transportation. Basically, just to summarize

that, the Department of Transportation said

that all transporters will need to comply with

applicable regulations set forth by USDA and

FDA, so basically, they passed the buck to

you \-- to FDA and USDA.

Our last identified gap was inspector

training, and we are definitely seeking input

from all stakeholders such that we have the

most knowledgeable and proficient inspection

staff possible. The AFS (sic) should provide a

program to ensure the competence and

proficiency of all regulatory inspection staff,

and this would include both FDA and state

inspectors. Questions?

FEMALE VOICE: No questions?

(Inaudible.)

DR. GRABER: We\'ll take a

question for Steve now that he\'s sat down. We

got a few minutes. Hold on. Get \-- Pass the

mike up here, Sharon.

MR. BRIGHTSMAN: John Brightsman

from Pennsylvania. I have a question for

Steve, as far as \-- You mentioned there are

regulatory enforcement tools that FDA have

(sic). Is that a gap? When you mentioned

that, is that a gap, or is that something \--

DR. TRAYLOR: That\'s not

necessarily a gap. It\'s just how we implement

those gaps on the enforcement side. We are \--

We\'re trying to incorporate into this system an

enforcement component, and those are the tools

that they have available. Should we have other

tools available to us from \--

MR. BRIGHTSMAN: Well, is that

something that should be discussed in the

breakout?

DR. TRAYLOR: That\'s something

that really should be discussed in the breakout

groups.

MR. BRIGHTSMAN: Okay.

DR. TRAYLOR: Right. And

there\'s some questions that you will get that

will sort of lead you down that path.

MR. BRIGHTSMAN: Okay. Great.

BREAKOUT GROUP EXPLANATION AND INSTRUCTIONS

BY GLORIA DUNNAVAN

MS. DUNNAVAN: We\'re gonna hang

on just a few more minutes. We want to give

you some really important instructions before

you leave today for a break and then lunch and

our breakout groups.

I\'m Gloria Dunnavan. I\'m the

Director of Compliance for FDA Center for

Veterinary Medicine, and part of the fun thing

with this meeting is I get to see so many of

you that I actually know or we talk on the

phone or we exchange e-mails. Thank you for

indulging me. I\'m not able to stand for any

length of time.

I just want to go over some

instructions. This is a really important part

of the morning, because you\'ll end up in the

right place and get your questions if you

follow all the instructions.

So basically, just listen carefully

for a few minutes. Check your badge. Your

breakout group is included on your badge. It\'s

the little top line in your badge, so I hope

you all have those. If you didn\'t check in and

get a badge, you need to do that at the

registration desk, \'cause it\'s critical to know

your breakout group.

The location of the breakout group

meeting are (sic) included in your packet.

There\'s a map. I don\'t have, actually, a

packet with me, but am I right? There is a

map, and the breakout groups are listed. So

it\'s a \-- not a huge hotel. Oh, here we go.

It\'ll look like this for those of you in the

front. This is not a huge hotel, so I think

you should be able to find it.

Lunch is gonna be served at noon, so

you\'re gonna have some time, between now and

noon, to, you know, make those all-important

phone calls, read your e-mail, do some

discussion, take a smoke break, whatever you

need to do before lunch. This is a working

lunch, so your breakout groups are gonna be

sitting together at lunch, so you need to look

for your breakout group numbers on the lunch

tables.

And just so you\'ll \-- Just to help

you out a little bit, breakout groups with the

letter \"A\" \-- When you go to the Regency Room,

which is where we\'re having lunch, breakout

groups with the letter \"A\" will be going to the

right, and breakout groups with the letter \"B\"

are gonna be going to the left, and the tables

are marked, but this\'ll just help you get to

the good stuff quicker.

Each breakout group is gonna have a

facilitator. They stood up this morning, so

you\'ll, you\'ll know they\'re the younger members

of this meeting, and there\'ll be at least one

Animal Feed Safety System Team member in your

group. Some groups will have more than one,

but there\'ll be at least one, and our, our goal

in participating in the discussion is not to

twist your arm or sway you or influence you in

any way, but if questions arise, the team

member is there to help sort that out. And

actually, I think all the committee members

have a little red flag on their badge that says

\"committee member\" or \"team member.\"

You are gonna receive a set of

questions, from your group facilitator, at

lunch, and you\'re gonna get all of the

questions. You\'ll get your groups, as well as

all the, the other groups. There are 12

groups \-- 12 breakout groups. There\'s 1A, 1B,

2A, 2B. 1A and 1B will be dealing with the

same question \-- same set of questions. 2A and

2B will be dealing with the same set of

questions. The only groups that are different

are 6A and 6B, will be dealing with two

separate sets of questions, just so you\'ll kind

of understand it when you\'re looking at, at all

of the questions.

And if you look on your agenda for

tomorrow\'s discussion, you\'ll see the names of

the different breakout groups, and they\'re

pretty much covering what we talked about this

morning, but let me just mention, there\'s a

breakout group on safe feed ingredients,

breakout groups on limits for feed

contaminants, one on risk and risk-ranking

model, one on process control, one on

regulatory oversight, and then the sixth group,

which is the one that\'ll have two separate sets

of questions, \"How can AFSS help you?\" So

those are our basic groups, and just be sort of

thinking about that.

Also, we like each group to cover as

many of the questions as possible. If you

don\'t get to all of \'em, it\'s okay. We like

you to try to take these questions in order,

but if you feel, as a group, that a particular

question is important and you\'d like to work on

it, you know, out of the listed order, that\'s

fine. This is not, you know, gestapo here.

There\'s no wrong answers. You know, don\'t feel

limited. Don\'t hesitate to ask questions.

We\'re really seeking your input.

We are gonna have laptops available

to record the information from your flip charts

so they can be projected on the screen when the

group reports. And I did \-- Although, it was

on my \-- on my slide, I failed to tell you,

when you first get into that group, be sure you

select a spokesperson and a recorder before you

get started on the questions. That\'s a

critical thing, and your facilitator is

probably gonna emphasize that to you, also, but

once you\'ve recorded the gist of your

discussions and your ideas for these questions,

you\'ll have flip charts to work from. Then

when you\'re finished, bring those flip charts

to the registration information table, and then

we\'re gonna have volunteers, this evening, type

the flip chart information onto the laptop so

we can project it on the screen.

I think that the size of this meeting

and the number of participants and the \-- and

the room arrangement, it\'s really gonna be

difficult for you to see flip charts, so we\'re

hoping this will help.

And then tomorrow morning each group

is gonna report the results of their

discussion. Each group is gonna have 30

minutes, and when I say you have 30 minutes,

remember, there are two groups. The 1A and 1B,

for example, have the same set of questions, so

those \-- That 30 minutes will be for both

groups to report.

And your leader for the discussion

tomorrow is Bob Wilson, and Bob will select,

you know, how he\'s gonna do the \"A\" and the

\"B.\" I don\'t know how that will work out. The

only difference here is that Group 6A and 6B

will each have 20 minutes for their report

rather than a, a total of 30.

These are pretty basic instructions.

You heard some of \'em earlier this morning.

We\'re just telling you again, just sort of

remedial training, \'cause this is really

important and will help get us moving and get

to the heart of what we want at this meeting,

and that\'s to hear from you.

With that \-- I\'m having to take any

questions about the procedural things

otherwise? George?

DR. GRABER: Any questions? Any

comments? As Gloria mentioned, this morning we

tried to \-- we tried to give you enough

background information so that the sessions

this afternoon would be productive, and we

certainly look forward to, to hearing the

reports tomorrow, but I\'ll be walking around

this afternoon, going to some of the groups.

I\'m looking forward to hearing what you all

have to say.

With that, we\'re a little bit early,

but that\'s fine. We\'ll \-- Again, we\'ll convene

at, at noon for lunch, and the Regency Room is

sort of back down towards the, the register for

the hotel and then down the hall, back towards

the \-- out where the elevators are, and hang a

right, I think, at the second bank of

elevators, and the room is sort of by the pool,

where the pool is. If someone knows a shorter

dis \-- a shorter way, fine. Otherwise, that\'s

the way to go. Okay. We\'ll see you at noon.

Thank you.

APRIL 6, 2005

ROBERT WILSON, MODERATOR

MR. WILSON: Start moving to

their seats, and we\'ll try to get started here

a little on time. Maybe a little early, even.

I do have one announcement to make about the

taxicab rides to the airport. It\'s my

understanding that the taxicab ride is a flat

rate, \$25.05, one, two or three people, however

many people go, so just for your information.

Good morning, I\'m Bob Wilson. I\'m

the moderator for today\'s session, and what

we\'re going to be doing is, is the

presentations from our breakout groups

yesterday. As you can see from the schedule,

we\'ve got a half hour scheduled for both Group

A and B, except for group 6, which each have a

half hour \-- or they have 20 minutes each.

What we\'re going to do is, the first

presenter for a group will have 20 minutes, the

second presenter for the group will have 10

minutes to give their presentation, and

hopefully, just cover the, the areas that are

different or, you know, if they concur with an

area, just so we don\'t have a lot of

redundancy, move through it quickly. So it\'s

gonna be kind of my decision who goes first and

who gets 20 minutes and who gets 10.

So what we\'d like to start with is

Group 1, and the \-- We\'ll start with Group A,

and they\'ll have 20 minutes to present \-- make

their presentation, and it\'s my understanding

the reporter for Group A is Bruce Arentson from

Kent Feeds. Bruce, you have 20 minutes.

BRUCE ARENTSON, GROUP A

MR. ARENTSON: 20 minutes?

Well, I can see the clock down there, so

hopefully I won\'t go over 20 minutes.

My name is Bruce Arentson, and I

work \-- do work for Kent Feeds. Good morning,

and we\'ll try to work through this this

morning. First of all, I want to say my

comments this morning are, are my comments, and

even the comments I make doesn\'t mean that I or

my company endorse this whole endeavor. I

may \-- I may bias what our committee decided,

but I have the microphone and they don\'t,

so . . . We\'ll build a foundation, hopefully,

this morning, at least in my presentation, and

then either we\'ll crumble today or others will

build on it.

Well, we had a question \-- or \--

Group 1, and the first part of our presentation

\-- or questions had to deal with the

definitions of \"comprehensive,\" and as you

remember, there are, I believe, if I have the

\-- eight points to the definition of what

\"comprehensive\" means, and we were asked: What

parts of the definition do we agree with? So

we decided to go down through, point by point,

those eight different points, and determine

whether we agree with these \-- definition of

\"comprehensive.\"

The first one had to do with: Does

it apply to the whole range of feed products,

including all ingredients and finished feeds?

And we typically agreed with that statement,

that if we\'re gonna do comprehensive, it has to

include all finished feed and ingredients.

No. 2, the use of ingredients

approved and/or recognized by an established

regulatory agency or entity whose members are

charged with the responsibility of enforcing

laws, regula \-- regulating the production,

labeling and distribution or sale of animal

feeds, and we probably have up there, I

believe, disagree with that at Point 1, if you

just go down there, and we\'ll talk about more

of that when we get down to the \"disagree\"

section.

No. 3, cover \-- had to do with cover

the range and variety of facilities involved in

animal feed over production, and there was

really a lack of consensus on this particular

statement, and we\'ll cover that when we get

down to \"disagree.\"

No. 4, have the flexibility to be

process- or product-oriented, depending on the

situation. Again, there was probably some

disagreement, and we\'ll talk more about that

when it comes down to the disagree part.

No. 5, address feeds produced for

food or nonfood animals, and we pretty much

agreed with that as, as written, and if you\'re

gonna have a comprehensive program, it had to

be both food and nonfood animals.

No. 6, cover all known hazards and

can be applicable to hazards not identified.

We didn\'t have a lot of agreement on the way it

was written there, and we won\'t cover a lot in

this section on that, and I\'m sure others have

a lot more to say about that today.

Address both human and animal health

issues. We agreed with that, that both human

and health (sic) issues will have to be in part

of the \"comprehensive\" definition.

And knowledge and coordinate

regulatory authorities at all level (sic),

including local, state, tribal and federal,

involved in safety. If it\'s gonna be

comprehensive, all regulatory agencies are

gonna have to be involved.

Then when it comes down to

disagreement, what parts of the definition do

we disagree with, we come to the first point,

which had to do with the feed products and so

on. We, we agreed with that. We didn\'t have

any disagreements.

No. 2, the use of ingredients

approved and/or recognized by established

authority. I guess we had some difficulty in,

in getting our handle on this part of the

definition of who \-- It\'s written, I guess, as

a committee. It\'s written kind of broad, and

we didn\'t all have agreement on this particular

one.

And then No. 3 had to do with the

complete range and variety of facilities

involved in animal feed production. We had

difficulty understanding what the range and

variety of facilities are and what \"animal feed

production\" means. We need to be more precise

in that definition. That\'s our thinking as a

company.

No. 4 had to do with the process- or

product-oriented, and I guess we\'ll deal with

that and address that later, and others, of

course, will have a lot more to say about that.

No. 5 addresses feeds produced for

food and non \-- nonfood animals. No

disagreements on that. We agreed with that.

No. 6 had to do with cover all known

hazards. We need to define what \"hazards\" are.

We really believe they need to be

science-based. We talked about adding \"all

known hazards\" and \"reasonably likely to occur\"

as maybe some better wording to put in that

question.

And No. 7 and 8, we both agreed with,

so we\'ll go on to our third question, was to

differentiate between process-oriented approach

and product-oriented approach, and we didn\'t

spend a lot of time on this. We were just

asked to at least give our thinking on what a

process approach would be, where testing is

performed using GMPs, or good manufacturing

practices, or SOPs performed, and that\'s all of

the approach or all the talk that we had about

that, and I\'m sure others will address that

later today.

Product. Basically, we\'re looking at

the final product and determining whether it

meets the specs on the guarantee, whether

labeling is correct and so on. So there is

some differences, and we didn\'t go much further

than that in our group.

No. 4 question was: Does the

proposed definition for \"comprehensive\" contain

any gaps? Is it too broad? You would \-- If

you would answer yes to either question, please

explain why. And again, we kind of went

through each point individually, and No. 1, we

didn\'t see any gaps. No. 2, we used \-- the

word \"entity\" is used to refer to mem \-- or

whose members are charged with the

responsibility of enforcing laws, regulating

the production and so on, and again, we think

that is too broad as a group. Our just \-- Our

group had difficulty understanding exactly what

we were referring to. Would it mean that the

foreign regulatory agencies wouldn\'t be

involved, or is AAFCO excluded? And as a

group, we had difficulty understanding this

particular point, and that\'s the bottom line.

No. 3 refers to a complete range and

variety of facilities involved in animal feed

production. Again, the gap and the definition

of \"what is a facility\" needs to be better

defined about what animal feed production is,

and would \-- Does that mean that the crops in a

field would be included? How do you define

these firms? How do you incort transporta \--

incorporate transportation? So we think it

needs to \-- It doesn\'t refer to any sort of

transportation, so that needs to be involved,

and just the little better definition of

\"animal feed production\" probably needs to be

involved in there. That\'s the consensus or

some thinking in our group.

Process or product control in No. 4,

who makes that decision of whether you use

product or process control, and when it says

\"depends on the situation,\" what does that

mean? Does the regulatory agency make that

decision, or does the facility make that decision?

No. 5, we didn\'t see any gaps in

that.

No. 6, it talks about all known

hazards and applicable to hazards not yet

identified. Again, we, we disagreed with this.

We think there needs to be some better

understanding of what the hazards are. We

think they should be science-based. All known

hazards \-- We, we just had trouble believing \--

or understanding the \"all known hazards yet to

be identified\" and including a huge, inclusive

statement like that. I think that probably is

what the committee was thinking when we talked

about that.

Nos. 7 and 8, we really didn\'t see

any gaps in that. I guess we just question \--

We think that a big gap would be the, the

ability for the regulatory agencies to, to

have \-- to regulate a comprehensive program or

to implement and enforce a comprehensive

program. We think that\'s a huge gap that needs

to be determined or figured out or, or \--

before we continue on and write a new program.

And then we go on to Question 5. We

have identified one gap in Component 1, which

is \-- which refers to the ingredients, and our

Question 1 is: Do you agree with the

identified gap? And the gap in the Component 1

of the program has to do with AAFCOOP, a

nonfederal listing as a source of information

on permitted ingredients and additives in

animal feeds, and there is really nothing that

pulls FDA and AAFCO federal listing together

and holds \'em together and bind \-- There\'s no

binding statement.

So there is a thinking that there

needs to be a compliance policy guide written

such that there is a guide to FDA people saying

that \-- as I understand it, The \-- We \-- We\'re

okaying the AAFCO listing. And we would agree

to a policy guide and recommend a policy guide

versus a regulation of some sort.

Getting back to the question: Do you

agree with the identified gap? Yes. And why?

From a regulatory standpoint, probably be a

good idea.

Another gap that we see in Question 5

is that there needs to be availability of the

OP to more people. That was brought up several

times. There were several people that didn\'t

have an OP and didn\'t know necessarily about

the OP, so \-- We just think that, that the

availability, especially of ingredient listing,

needs to be widely distributed.

There needs to be some transparency

for new approvals of ingredients so that the

public knows what\'s going on. There was some

thinking that not everybody understands the

process or realizes the process that\'s going on

or knows that there\'s a new ingredient, and so

there needs to be more publicity about that,

maybe through Websites or, or mailings or

something to that effect.

Going on to Question 6: Do you agree

with the identified gap? Why? And then 7 and

8, during the last part of here \-- our section

here, what we have written up here, I think we

kind of put everything into one, so it\'s a \--

I\'ll just read the questions and then we\'ll go

through what I have up here. What gaps have we

missed, and what solutions do you recommend to

fill those gaps, were our two remaining

questions. And then we\'ll just talk about some

of the things that we have written up here.

Again, getting some of the

acceptability of the human food grass

ingredients, there was some talk in our group

that some of the ingredients used for humans

are not accepted for the animal sector, and

even that process is not defined of how that

can take place, and so there was some feeling

that we should have a process that\'s kind of

outlined and defined so that we \-- people,

companies, know how that takes place. One gap

is, if you do get a new ingredient approved,

there\'s no market protection for that feed

ingredient. Others can market that same feed

ingredient.

We need to have the regulations

written, easily acceptable \-- or accessible to

everyone. Sometimes they\'re not especially \--

if \-- And I think \-- Scroll down to the next

one, and \-- next page, and then I think we\'ll

be done. Sometimes \-- I think \-- I got to

think back to see what we were thinking about

this, but one thing I think we brought up in

our group was that if we\'re to have a new

program, it needs to be accessible to any \--

everyone and understandable by everyone.

Now, if \-- Even if you look at the

present written program, and there are a lot

of \-- lots of different informational pages,

Websites, the CFR, the AAFCO, and for someone

new or someone that doesn\'t work in this arena

every day, it\'s very confusing and very

overwhelming. So if it\'s gonna be

comprehensive and we\'re gonna include a lot of

different people in the comprehensive

regulatory program, it has to be simplified,

has to be readily accessible to everyone, and

they have to be able to understand what they

need to do in their particular program.

With that, I think I\'ll quit and give

the podium to Group 2A.

MR. WILSON: (Inaudible) B.

MR. ARENTSON: 2B?

MR. WILSON: 1B (inaudible).

MR. ARENTSON: 1B.

MR. WILSON: (Inaudible.) Just

before 1B \-- As they\'re making their way up, is

there anyone in Group 1A that would like to add

anything? We have the microphones available,

if you would. It\'s very good on time, by the

way. Excellent. Elwin (phonetic)? All right.

The spokesperson for the re \-- or reporter for

Group 1A \-- or 1B is Sara Blodgett?

MS. BLODGETT: Yes.

MR. WILSON: All right. I

didn\'t ask you your name.

SARA BLODGETT, GROUP 1B

MS. BLODGETT: Good morning.

I\'m Sara Blodgett, and I am with Farmers Coop

out of Farnhamville, Iowa, and I\'m the reporter

for 1B, and we had a lot of similar comments

that 1A had. For Question No. 1, what do we

agree with? We agreed with No. 1, 4, 5, 7 and

8 as written. We didn\'t have any changes or

differences with those.

For Question No. 2, what parts did we

disagree with? Items No. 2 and 3, we thought,

were rather broad, and we needed to add the

entities of storage, transportation and use on

No. 2, and we needed to add storage,

distribution, transportation and use to No. 3,

because those entities are just as important as

the ones that were mentioned and play an

integral part, also.

The next one that we disagreed with

was No. 6, and we thought that that was too

broad, because it just says \"all hazards and

unidentified hazards,\" and we thought that it

needed to say \-- be further defined as hazards

that are science-based and reasonably likely to

occur.

For Question No. 3, we had a lot of

discussion on this, and I don\'t know if we

necessarily came to any specific conclusion as

to how they should be defined, so what we

decided was that each entity needs to have its

own plan of how to get to a safe end product,

and the key to the process-oriented and

product-oriented was mainly that we have a safe

end product at the end, and we didn\'t have any

specific definition for each of those.

Question No. 4. The gaps, as I

mentioned earlier, we referred back to Items

No. 2 and 3, where we thought we needed to add

the transportation, storage, distribution and

use to those.

And too broad was Item No. 6, where

we needed science-based and reasonably likely

to occur so it wasn\'t so broad and open-ended.

Question No. 5, which was: Do you

agree with the identified gaps and why? We did

agree with the identified gap. We also

disagreed, as you will see in the next

question. The reason that we did agree was

that the CPGs would formalize the understanding

between FDA and AAFCO, which we felt was

important, and No. 6, why we disagreed, is that

our group thought that we would prefer a CPG to

a regulation. They felt that a regulation has

the potential to be a significant regulatory

burden, so they would prefer that we just stay

with a CPG than set up specific regulations.

No. 7, what gaps have been missed?

No. 1, we thought that, currently, there is no

mechanism for evaluation and reviewing the

grass substances to be used as feed

ingredients, and secondly, we also believed

that, currently, there is no rapid, validated,

inexpensive test for certain hazards, so we

need to get those created.

And No. 8, what solutions do we

recommend to fill the gaps? Our group

recommended that the grass notification

proposal be implemented.

And that\'s all we have, unless

somebody in my group has something to add.

MR. WILSON: Is there any

questions of Group 1? No one has any questions

of Group 1 or anything like that? Very good

presentations, no questions. All right.

Continuing on Group 2, I\'d like \--

Let\'s switch and have 2B reporter be the

primary reporter for this, this group, and that

would be Michael Davidson, I believe, and then

2A \-- He\'ll have 20 minutes, and then group 2A

will have 10.

MICHAEL DAVIDSON, GROUP 2B

MR. DAVIDSON: Morning. I\'m

Mike Davidson. I\'m with the Republic of

California Department of Food and Agriculture.

Our group was, was looking at the limits for

animal feed contaminants, and the \-- It was

pretty much agreed upon in the group that this

is gonna be a \-- quite a daunting task to do

risk assessments for all potential hazard

contaminants, and basically, the, the first

question: What gaps do you agree with? This

is pretty much consensus throughout the group:

As long as it was science-based \-- And they

felt that on the \-- Oh, thanks. Hmm. They

felt that it needed to complete the risk, risk

assessments before attempting the second part,

with developing methods for analyzing these

things.

The, the other thing was that we felt

that it \-- there needs to be some clarification

on the third question, and basically, it was

about \-- A lot of this really \-- The group felt

that the key component was prevention through

biosecurity, but that the AFSS system would be

put in place after an exotic animal disease is

diagnosed, and then the Feed Safety System

could work on tracing back feed.

Then: What gaps do you disagree

with? On \-- There needs to be training.

Levels need to be established, by a regulatory

agency, on the, the hazardous contaminants, and

then these standards need to be reviewed

regularly, not just left in place forever. And

then the standards need to be realistic. If

you can\'t \-- If the background levels are the

same as the minimum standards, it\'s \-- and you

put the industry in a possible situation, they

felt that that\'s just totally unrealistic, and

based on science, again.

Then again, the, the third point,

again, as \-- I\'m repeating myself \-- that on

a \-- If there was exotic animal disease, the

best medicine would be prevention in the form

of biosecurity.

What, what gaps have we missed? On

the first point, the risk assessments must be

species specific where appropriate, and that

was identified, a couple of comments,

yesterday.

And then the second point on, on the

analysis of hazardous contaminants, that it

felt like the \-- all the laboratories that \--

should be identified, they were capable of

analyzing hazardous contaminants, and that

these would be available for industry and

producers so that if anybody had a problem on

an on-farm mixer situation, they had a lab that

they could go to, and then the, the limits that

the lab was capable of doing should be

identified, and also, have a listing of labs

that had a specific matrix. In other words, if

they can analyze liquid feed for a specific

contaminant, for example.

Some of the solutions that we had to

fill the gaps \-- This is gonna be \-- The risk

assessments are gonna be, like I said, a very

daunting task, and it should be a cooperative

effort between federal, state, academia and

industry groups, and also, because of the

global economy, that we should consider

international standards, and then the

laboratories need to be certified by type of

analysis. Improper information or false

reporting of a hazardous contaminant was felt

to be highly destructive, and we wanted the

results to be \-- or the labs to be certified

that they are capable of \-- and they have the

quality assurance steps in place. And then

this was kind of a pipe dream, but unlimited

research funding, and what the group said was,

Well, if you don\'t ask for it, you know, you

can\'t get it.

Anyway, the \-- On the \-- Question 5,

did we explain clearly enough? There was a lot

of discussion, but the consensus was no, and

what was confusing, there was \-- it was never

established at what level \-- where risk is

regulated, and the \-- One of the things that

they felt would be helpful is an example of how

\-- something that\'s currently regulated, how

that risk was established and what the steps

were, and just a couple of examples for people

to understand what to expect from this

risk-based assessment of hazardous

contaminants. So if we could have gone through

and better explained how this whole process

was \-- is likely to work in the future based on

the things that FDA has done in the past.

Question 6: Do you think AFSS should

use risk-based? And the answer was yes. What

other approaches should we consider? There,

there was considerable discussion on

record-keeping and complaint files, recalls and

whatnot, but based upon our part of the

program, the limits, we didn\'t have any other

recommendations.

Is the new risk-based definition more

understandable? Yes. The only \-- We felt that

the second definition on that single page was

much more clear and that \-- It \-- It\'s this

single page in your packet, \"Definition of

Risk-based.\" The only thing that we added

was \-- On the bold portion in the middle of the

paragraph, where it says \"animal and human,\" we

added \"animal and/or human exposure.\"

And that was \-- that was pretty much

it. Does anybody from 2B have anything to add?

Thank you very much.

FEMALE VOICE: (Inaudible)

question.

MR. DAVIDSON: Yeah.

FEMALE VOICE: What do you mean

by \"prevention\" (inaudible)?

MR. DAVIDSON: \"Prevention

through biosecurity\"? Well, they were just \--

The question is: What do we mean by

\"prevention through biosecurity\"? Well, the,

the Point 3 was about how AFSS could assist in

the event of an exotic animal disease, and we

felt that there should be \-- On the on-farm

mixing and many feed-manufacturing locations,

the accessibility to these locations by

unidentified people was a very common practice,

and so whether it was intentional or somebody

bringing pathogens from one location to the

other, that the prevention of something like

that is the key and that, really, you\'re not

gonna be able to test for exotic animal

diseases in feed, on a regular basis, that you

would respond after it was diagnosed. Does

that answer your question?

FEMALE VOICE: Yes.

MR. DAVIDSON: Okay. Do you

want a microphone?

FEMALE VOICE: I think with the

experience \-- with the experience that you\'ve

had in California with some of the exotic

animal diseases, you probably have a little

more sensitivity than, than, maybe, some of

your counterparts, but what I\'m understanding

is that, that when you mention prevention in

the form of biosecurity, you\'re talking about

limited access \--

MR. DAVIDSON: Cor \--

FEMALE VOICE: \-- as one factor?

MR. DAVIDSON: That\'s correct.

And, you know, the \-- Any, any vehicles or

people that are exposed to where livestock are,

that they be sanitized before they go from one

location to the other.

MR. WILSON: Do we have any

other questions? Okay.

And the presenter for Group 2A, Amy

Wesley.

AMY WESLEY, GROUP 2A

MS. WESLEY: Good morning. I\'m

Amy Wesley, and I\'m with Murphy-Brown\'s out of

Algona, Iowa.

Our group took a different approach

on answering these questions. We\'ve lumped

Question 1 and 2 together if we agree or

disagree on the gaps that were presented in the

framework. As discussion started, Greg did a

good job of, of paraphrasing everything, and we

didn\'t say yes, we agree or disagree. These

are the comments that came out, questions. We

were all, I think, trying to grasp how the

model was gonna work, how the components were

gonna be put together, and so these are the

comments and opinions and questions that we had

as a group.

Do we agree or disagree with Gap 1?

And I \-- You can refer back to the framework

document for Gap 1. We thought we needed to be

cautious when using the word \"potential\" and

\"potential\" hazards, biological, chemical and

physical contaminants. What is really meant by

the word \"potential\"? We wanted to be sure we

rely on science-based data when making the

regulation or decisions.

Must be con \-- be a consensus about

the methodology used when measuring and qui \--

quantifying risks. Be careful about using risk

models for which there is not significant

scientific consensus.

One firm had linked the factors of

HACCP program. HACCP was passed back and forth

in our group discussion yesterday. When adding

animal risks and human risks, we had to be

really careful on what control points need to

be looked at.

Will the risk ranking for animals and

humans be separate? These are questions that

came out that we wanted to understand how this

was all put together. If combined, the agency

needs to develop a consensus about weighing

human and animal risks. How much is a human

death worth compared to an animal death?

Is \-- The risk-ranking model, should

it be able to be used and tested by the

industry, as well?

And where this next comment came

from \-- I don\'t remember it being written down.

If it looks like HACCP, smells like HACCP and

sounds like HACCP, it is HACCP. And if there\'s

questions, we can refer that back to the rest

of the group.

FDA does not appear to be focused on

HACCP for this risk-assessment model.

Can information or approaches be

used \-- in the Harvard BSE Risk Assessment, be

useful for the AFSS risk model? Is there other

risk models out there that need to be looked at

to, to bring back and help put this model

together?

Gap 2, these are the comments that

we \-- they agree/disagree, the comments that

came out of that: Availability of effective,

inexpensive and reliable testing methods is

crucial. Industry may need to help develop

some of these methods. And will the FDA will

be likely (sic) \-- not be able to develop all

of the methods that, that are needed for this

testing?

Gap 3: Historically, FDA has played

a limited role in these matters. How does this

fit the \"F\" \-- Gap 3: How does this fit into

the \"F\" \-- the AFSS? How do agroterrorism

risks compare to the usual feed contaminant

risks? What contaminants\' agents\' hazards has

the FDA identified for agroterrorism? If FDA

uses something other than exposure to rank

these risks as agroterrorism agents, what will

it use? What are the facilities, processes or

product risk factors associated with the

vulnerability of agroterrorism risks? How will

these risks from products produced in other

countries be evaluated for agroterrorism risks,

particularly if the FDA relies on process

control model and doesn\'t have access to the

plants in other countries? So we went outside

the realm of what we do here, but how can we

control what\'s coming into the country, as

well?

How will the risks from products

produced \-- Whoop, got that one already.

Sorry.

Question 3: What gaps have, have we

missed? We thought there needed to be more

emphasis and explanation, and perhaps in the

models, in how it\'s gonna handle imports.

Even when science-based decisions are

made about feed safety, we \-- can we have the

WT \-- what problems can we have with the WTO on

science-based decisions? Process-based

controls are more difficult to enforce for

imports. Risk systems must look at entire

supply food chain, chain for feed and not focus

on only the segments of the feed industry. It

also should be more explicitly defined in terms

of processing steps.

What can be modified, the original

risk scores, for ingredient hazard pairs? So

we kind of wanted to get away from more

focused, and some of the statements was

focusing on feed aspects, but we need to

incorporate the whole chain of transportation

ingredients and the whole process in how things

are worded so it includes the whole realm.

Will regulations be applicable to

farms? Will risk assessment consider some

risks are industry-segment-specified or

species-specified?

To what extent does the AFSS consider

or address the issues of ingredient

traceability? International sources of

ingredients may pose particular problems with

reg \-- with regard to traceability.

How does the AFSS consider the

response time needed to prevent an emergency

situation from becoming a crisis? Do we need

to take 10 days before we realize there\'s a

problem, and by that time, there\'s product

halfway across the world, or what\'s that time

frame that needs to be established?

We need a clear information on

limits. For example, if there\'s a dioxin limit

of 10 parts per million, what will the agency

do if a sample tests 15, a hundred or even a

thousand? What does the agency expect the

industry to do in each of these situations? We

kind of want a specified outline of: If we\'re

over the limit that may be set, what do we need

to do?

FDA needs to link risk ranking/risk

assessment with regulatory actions. How will

FDA approach working with on-farm

transportation and other parts of the food

supply \-- the food supply and FDA does not \--

that they don\'t regulate now? Will guidance

levels or action levels be set for some limits?

Will the risk-assessment method \-- What will

the risk-assessment method be when setting such

limits? Will it differ from the method that\'s

used to rank these for the AFSS?

Question 4: What solutions do we

recommend to fill these gaps? Go out and

utilize trade association, universities and

private industry feed safety programs that can

be used to help set up these models and

resource for the agency. FDA should attempt to

secure funding to develop testing for methology

\-- for methodology, and that will be a long

shot, as was mentioned earlier. Very expensive

to develop those tests. FDA will be able to

develop validation guidelines for the industry

to set up methodology processing. FDA should

search globally for technological innovations

that may influence risk, and will the FDA

become more efficient through implementation of

the AFSS? are questions that were posed.

Question 5: Did they explain clearly

enough how we plan to use the risk information?

We wanted to see an example of how that risk

model is gonna work before it either, \"A,\" goes

into regulation or becomes a suggestion.

Show what happens to the risk ranking

when some changes \-- when you change some of

the assumptions to the risk model. Make sure

clear definitions for each category of the

sources, ingredients and processes are

provided. Will expectations about resources

change if the AFSS is implemented? And how

will the AFSS affect the current feed

ingredient approval process?

Question 6 was \-- It\'s not listed on

my paper. How would you \-- That\'s not even our

question. Sorry. Turn it over. Do you think

the AFF \-- or the AFSS should use risk-based

approach to determine which feed contaminant

needs to be reduced, eliminated or controlled

in the feed and feed ingredients? Any

scientifics-based (sic) approach include risk

assessment and should be okay, is the group

consensus on that one.

Programs should keep in mind

potential media usefulness and reaction and

develop, and any approach used is effective.

Information guidance to provide any

agency may be useful, but if the guidance is a

requirement in sheep\'s clothing. Now, I don\'t

remember this one coming up either, but \-- It\'s

good as it\'s given in guidance, but once it

becomes a regulation, everyone thinks on it

differently.

How will the AFSS be modified as we

move forward? Will there be other

opportunities for public comment? Will the

model and the AFSS system be designed to permit

easy modification as environments and risks

change? Will FDA continue to evaluate data

affecting safety and risk? Will periodic

review of the data used in the model be built

into the AFSS?

The last question, which didn\'t make

this: We have modified the definition of

\"risk-based.\" Is the new definition more

understandable? I believe our group agreed

that it was more understandable. One comment

that, that I can remember is that it needs to

include and state both feed and feed

ingredients to kind of cover the whole realm.

These are the comments and questions

that we had when we discussed these questions,

and anybody that has comments about this

component, feel free to fill out one of those

comment cards in the back.

MR. WILSON: Then we continue

on. I think we\'re up to Group 3A, and the

reporter is Blaine Hull.

BLAINE HULL, GROUP 3A

MR. HULL: My name is Blaine

Hull, and I am a reluctant spokesperson for our

group. My thanks go to Heidi for recording all

this information down and the nameless

volunteer that typed it up on our sheet last

night.

We centered most of our efforts on

the gap for Component No. 3, and I\'ll read that

just \-- I\'m sure most of you have it

memorized \-- this is exciting reading \-- but

for those of you that don\'t, follow along.

Currently, the FDA has regulations that govern

the controls used in the manufacturing,

packaging, storage and use of medicated animal

feed; however, to have a comprehensive Animal

Feed Safety System, a broader regulatory

approach may be required to address feed safety

concerns associated with the manufacture,

packaging, storage, distribution or use of

nonmedicated feed ingredients in mixed feed.

The AFSS team intends to consider the

information gleaned from the public meetings

and from responses to the materials placed in

the AFSS docket in its development in \-- of

process-control approaches.

We had eight questions, and I haven\'t

seen this, so I\'m gonna go just off what I

remember us discussing, and then those of you

who feel that\'s not a true representation of

what we talked about can stand up in a second.

Questions 1 and 2 were problematic

for us because of \-- Do you agree with the

identified gap? Yes, we agreed that there was,

in fact, a gap. Do, do you agree with the

identify \-- Do you disagree with the identified

gap? Yes, we do, and the exception that we

took was to the second \-- the second line,

which states: However, to have a comprehensive

Animal Feed Safety System, a broader regulatory

approach may be required to address feed safety

concerns. We had \-- We had a difficult time

with the regulatory part of that concern.

We, we recognize that there is a gap,

of course, between some facilities. Those of

us who are highly regulated would like the rest

of you to share in that joy, I think was the

consensus, really. Either that, or those of us

who are currently feeling the joy would like to

stop that, depending on, on, on that. That\'s

good.

The FDA currently doesn\'t have the

authority to demand process control by

industry, and, and that\'s not entirely true, as

was brought up \-- There is a system in place

that will take care of these sort of concerns

now in just the FD&C Act itself, and so what

solutions do we recommend to fill the gaps? We

had written on our sheet, in great big, giant,

bold print, \"no additional regulation,\" and

there wasn\'t a \"please\" there, but we\'ll say

\"please\" just the same, because it was felt

that there is current \-- currently in place, a

way to take care of that problem.

No. 6: Would it be appropriate to

recommend that firms develop written standard

operating procedures for the entire feed

production process? Alternatively, would it be

sufficient to recommend that firms develop

written SOPs for only those process steps that

directly impact the safety of the feed?

Correct me if I\'m wrong, but I believe our

consensus was that a minimum amount of required

SOPs would be sufficient and not the entire

process.

Now, we \-- In, in saying that, we

wanted to make sure that any, any requirements

that \-- Isn\'t this fun, trying to figure out

where I\'m talking from? I don\'t know where

they are, but \-- Just ignore that. Okay. Hang

on right there for a second. I\'ll get there.

Just requiring the limited amount and

making sure that if it becomes a compliance and

regulated thing, that our requirements are

clear. There was a question of whether or not

they should be gen \-- broad generalizations as

to the \-- as to what our responsibilities would

be, and our response to that question was: No,

they need to be very specific to ensure that

there is no interpretation of different

inspectors, that we know very clearly what

we \-- our responsibilities are and can,

therefore, fulfill them completely.

With limited regulatory resource, we

should focus on hazards instead of \-- Yeah,

okay. That\'s pretty clear.

How should the process-control

component incorporate feed-safety-related

transportation concerns for both incoming

materials and the outgoing products? That\'s

Question No. 7. Basically, doing what we can

to secure our facilities, secured drop pits,

covered trucks, locks on train cars, those kind

of things, were what \-- basically, what we came

up with.

No. 8: As envisioned, the Animal

Feed Safety System addresses the labeling,

production, distribution and use of all feed

ingredients and mixed feed regardless whether

these products are produced at commercial

operations or on farm. How should the

process-control component of the AFSS address

the use, feeding or feed ingredients and mixed

feed on the farm? What type of on-farm

controls should apply to animal feeding? That

was a very difficult question to answer because

we recognize that, in fact, the agency has very

limited funds, very limited resources, and to

expand the scope of, of their responsibility

from, from the, the medicated facilities that

they have responsibility over now to every

single solitary manufacturing facility, large

or small, and farms, we, we couldn\'t come up

with a way to make that work.

And so, again, with the FDNC that\'s

already in place, should there be a \-- should

there be a challenge? We determined that

perhaps it would be better not to start

something else, to expand regulation, where it

really can\'t be done effectively.

Okay. Scan through those now, and

let\'s see if I\'ve missed anything. Oh, hang on

a second. The problem is the reaction versus

proactive. We felt that, in fact, FDA\'s

current method to deal with these is more

reactive than proactive by just necessity, not

necessarily by choice. That was just how it

has to be. And we would like very much for

there to be educational components to the

industry so they can tell us exactly what we\'re

supposed to do, because that will help us

comply.

Okay. Let\'s see. There \-- First

visit with education in mind. That\'s right.

That\'s right. It was suggested that, in fact,

we get a freebee. First time we\'re not gonna

lock you up if we come over and find that you

guys are not doing it, but that that would be

our \-- a way for us, as an industry \--

especially if there are new guidelines in

place, for us to understand what our

responsibilities are.

Okay. Agroterrorism concerns.

Really, that was just common-sense stuff again,

just locking up our facilities, \'cause it\'s

kind of hard to prepare for a problem that

there isn\'t really any set \-- You know, if we

\-- If they just give us an itinerary of how it

was gonna work, then we could plan better for

it; okay?

Okay. That \-- Okay. All right. I

believe that\'s all our group discussed. We

discussed many things. Sometimes the

discussion was pointed, but it was good.

From that group, now, are there any

things that I missed?

MR. COSTIGAN: Tim Costigan with

Prince Agroproducts. We got a little bit into

the discussion about being proactive or

reactive, and out of necessity, we feel that

most of the regulatory agencies are reactive.

They find a problem either in feed or they find

a problem in a food site, and they investigate

that back, try to identify a source, and that\'s

very helpful.

The responsible industry and

responsible individuals involved in the

industry tend to be more proactive, and that\'s

really their role in this whole scheme. If

they can take a look at their process, evaluate

where risks come in and take care of that, then

that certainly makes the entire feed system a

little bit safer.

There\'s kind of that third group

there, and that\'s the group that\'s really of

concern. They\'re inactive. They really don\'t

do much of anything to prevent safety concerns.

They\'re not overly concerned about \'em. Part

of it is due to ignorance or, or, you know, not

understanding what they need to do, but I think

there are individuals who just aren\'t

interested in that part of it. They\'re there

to make a buck. They want to move on.

So the real question with the Animal

Feed Safety System isn\'t how do you put more

regulation on industries that are willing to

comply, but how do you bring the rest of them

into the fold? And that\'s something that this

system needs to address.

MR. HULL: Any others? Okay.

Thank you.

MR. WILSON: All right. Now, we

have one question here. We\'ll \--

MS. DUNNAVAN: I, I want to ask

the group a question.

MR. WILSON: Okay. Just wait

for the microphone.

MS. DUNNAVAN: Well, I

(inaudible) \-- Ferris, can you go back to the

very beginning of their \-- I just wanted to ask

this \-- the group, \'cause I don\'t quite

understand \-- In your comment here, regulation

should be based on end result, some agreed with

this only with respect to the regulated

industry segment, which is medicated feed. In

this respect, the term \"process control\" is

wrong. Can you explain that? I \-- I\'m not

sure that I quite understand what you mean by

\"process control is wrong.\"

MR. HULL: Honestly, I can\'t

explain that paragraph, because I don\'t

remember it being one of our conclusions, so \--

Is there anybody in the group that can address

that?

MALE VOICE: Is this on? We

felt there is a lack of understanding, Gloria,

to what \"process control\" means, that there is

a need for upstream and downstream controls

from the feed mill and that the term \"process

control\" implies controlling a particular

process \-- i.e., feed manufacturing \-- and

that, therefore, we need to incorporate some

other terminology in order to address those

types of systems they use.

MS. DUNNAVAN: Thanks,

(inaudible).

MR. HULL: To expand on that

just a little bit, when we were talking about

process evaluations, you know, I think that\'s

maybe a little bit clearer term for people, but

looking at the process control, there\'s two

aspects, and I spoke about that a little bit

earlier. When you have no process to control,

you\'re handling a material produced by someone

else and you cannot get to their process,

whether it\'s overseas or someone that you

really don\'t have access to, then you need to

revert to the product control. And just

referring to process control, it left it

awfully wide open. It was not easily

understood, and it\'s a term that\'s better

understood in many other industries to mean

other things.

MS. DUNNAVAN: Thank you all.

MR. WILSON: Okay, Lee

(phonetic). Any more questions I \-- Oh, we

have a \--

MS. PETERSEN: No, I \-- Just a

comment. Process control \-- This is Marlene

Petersen with Milk Specialties. Process

control is generally considered to be a quality

program, not a hazard or risk-based program, so

in the industry, if you use the, the name

\"process control,\" you\'re generally talking

about quality programs which are not

necessarily applicable to what we\'re talking

about here.

MR. WILSON: Any additional

comments? Okay.

We\'d move on to Group 3B. Randy

Sample is the spokesperson \-- the reporter for

this group.

RANDY SAMPLE, GROUP 3B

MR. SAMPLE: Good morning. We

had many of the questions that the previous

group worked on. I\'m Randy Sample with ADM,

Alliance Nutrition and Animal Health Nutrition.

I\'m affectionately known by our marketing

department as Director of Sales Prevention,

so . . .

We looked at: Do you agree with

identified gap? And this area worked \-- The

objective was to develop a framework for the

use in prioritizing and allocating inspection

enforcement resources to minimize a risk of

animal and human health, and the gap that was,

basically, identified in here dealt with the

hazards of the Bioterrorism Act and controlling

livestock diseases and bringing in the

transportation issue. I said, Do you \--

We did it a little bit differently

than the other people reported. We kind of

broke it down into the industry\'s concern, the

state concerns and the FDA concerns, so we felt

like, in many cases, they were a little bit

different. We wanted to get those down and \--

that we could discuss.

I said, Do you agree with the

identified gap? I think we all said \--

industry said yes. We agreed that the gap \--

We feel that on-farm operations or nonmedicated

feed mills are the missing link that\'s not

being looked at previously. FDA says they have

the authority to go on farm now and the FDA

authority to inspect unlicensed plants, but

they don\'t routinely do this. That falls under

the state purview, and the state side of it

said some states may not \-- don\'t have the

authority to go on farm, and some may not want

the authority to go on farm, unless they\'ve got

the governor of California to go in with \'em as

a backup.

And yes, we do \-- did agree with the

gap. The \-- Question 2 says: Do you disagree

with the gap? We said no. What gaps have we

missed? We had a lot of discussion on the

transportation issue, how it was dealt with

within the framework. I think you also \-- We

thought that the local farmer transporters

needed to be dealt with because they were also

a possibility or a risk area that could cause

contamination.

And then, again, we brought up the

age-old comments about the railroads. How do

we get the railroads to buy into this process

without just having us \-- We won\'t give you a

car to load your feed.

So those are things, I think, we all

are dealing with. We need a standardization

form, that accompanies shipments, showing

compliance with AFSS procedures. We sort of

answered this again in Question 4. And also,

we need to look at the mixing at the farm

level, but there\'s also manpower issues to

implement on the industry side and on the

regulator side, and again, a lot of discussion

was held on equal enforcement. As a gentleman

earlier talked about, you know, we all are into

this inspection mode, and sometimes it\'s, Get

all the inspections we really don\'t need. With

all the BSE and other issues, I wonder if \--

sometimes, that, you know, they should kind of

be combined.

And also, it comes down \-- They felt

like the cost of the farmer was going to be an

issue, and it comes down, it\'s gonna be forcing

more of the prac \-- to go the route of

integration that the poultry industry and the

swine industry is going to very quickly.

What solutions do you recommend to

fill the gap? We felt like the industry was \--

need to catch up other groups \-- i.e., the

transporters and on-farm processes \-- before

putting more regulations on the feed industry

in general. We thought that a standardized

form for compliance with AFSS was needed to

cover the farmer transporters.

And for gap on dealing with farmers,

we need to make it appealing to the farmer to

be interested in the process and in the

products that are in compliance, and possibly

would go through \-- via the different, like,

pork board associations to get this word out to

these different farm groups. I saw the

certificate \-- certification of buying, selling

appeal \-- certification received due to going

through training, and the training sessions

need to be held through all processes \-- all

steps of the process.

I also felt like that a national

animal I.D. system would be needed. States

felt like, currently, the I.D. system is for

disease traceback. Therefore, information may

not be available to do all that we want to do

or provide.

For dealing with the on-farm mixers,

we like the certification of training, and the

industry felt like we\'ll need deadlines for

training or you\'re-out-of-business-type

process. Joint meeting with pursuit \--

producers and farmers and tell them to bring

their books to show that they are complying

with that.

And FDA felt like the

recertification, after a required number of

hours of training, pretty much like some \--

where the pesticide industry has gone. And for

manpower on how to do this, we don\'t know. You

know, we couldn\'t come up with some real issues

with \-- there.

As far as dealing with enforcement,

felt like that there isn\'t equal enforcement

now, through that lower part of the pyramid, to

the on-farm, to the small producers.

How do (sic) the process-control

component incorporate agroterrorism concerns?

We felt like we needed to show or get complete

compliance with the Bioterrorism Act, and it is

impossible to check every contaminant. We

could, but no one could afford our fee.

Facility security, we talked about

that, how the small operations can make their

systems more secure, and felt like we also

needed to know our vendors who we\'re getting

product from.

Educating. The states felt like

educating parties need to be involved in what

they\'re affecting. Assess the risk within your

facility or process, the vulnerable points, and

the impact that agroterrorism may have on those

points. We also felt like we needed to be able

to reference lists of who to call if a

situation occurs. Like if you know a

contamination happened in your plant or in your

operation, who do you call first, or how do the

contacts need to be made? Reactionary plan

for: If something happens, what do you do?

Mock recalls, mock inspections should be the

norm.

We also felt like training employees

to look for things that are odd. I think one

of the people in our group had some background

in the enforcement area and felt like we need

to train people how to look \-- if something is

out of place or just doesn\'t look right.

Question 6: Would it be appropriate

to recommend that the firms develop written

SOPs for the entire industry production

process? I think the industry side of it said

they like SOPs, and farmers have a difficult \--

difficulty passing the cost of keeping SOPs to

someone else. A lot of discussion was on, we

can \-- As an industry, or ingredient-wise or

production-wise, we can pass these costs off to

the farmer, but the farmer doesn\'t have that

same opportunity to pass his costs off to who

he sells his product to. And who is going to

do the SOPs for the farmers and the mom-and-pop

mills? That question was brought up. Should

we provide them assistance in doing this? We

like the idea, but it\'s hard to implement at

the farm level.

And Question 6 is: Alternatively

would (sic) be sufficient to recommend that

firms develop written SOPs for those process

steps that directly impact the safety of feed?

It says \-- The industry said, Difficult to

separate what does affect the safety of feed,

because it all does to some point.

Must be careful when writing SOPs.

If you write a garbage SOP, you will have a

garbage product. And we went through the whole

issue about \-- We have people out there that

want low-cost products, so the industry has a

blast with that. Might consider making SOPs

for known hazards. Of course, we felt like

that was difficult to test for everything. In

the FDA, some parts could be pulled out,

exemp \-- SOPs if it does not affect the safety

but only affects the quality: the size, the

crumble, the fines in the feed and those areas

that doesn\'t really affect the animal. States

felt like they needed generalized SOPs, not

specific ones. How do we do this? We don\'t

know. We like the idea. We don\'t know how to

implement and enforce these.

Question 7, we kind of went back to

Question 3, where we talked about the

transportation issue and what needs to be done

in that area to the truckers and the railroad

companies.

Question 8: How should the

process-control component of AFSS address the

use of feed ingredients and mixed on \-- feed on

the farm? I \-- The industry felt like we have,

have met \-- (Inaudible).

(Inaudible.)

MR. SAMPLE: Okay. I didn\'t \--

\-- packers mandate \-- put pressure on the

farmers, the farmers follow the process \--

procedure. So that was probably one area

that \-- And you see a lot of this coming from

Japan and the foreign market, where they\'re

demanding certain things be done.

The states also felt like that

there\'s a niche market people out there more

difficult to bring into compliance. People who

are selling organic products or unnatural

products or specialty products would be hard to

reach with this process.

And we had one comment I think you

hear about at any meeting: We need to teach

farmers how to read the labels, \'cause many

times, that\'s not done. FDA said they had

jurisdiction over the animals, maybe also under

USD \-- USDA control.

And the Question A \-- Part B, what

type of on-farm control should apply to

feeding \-- to animal feeding? A farmer should

not have to pay for this. Consumers want it;

they should pay for it. Comes back to: Have

we seen a groundswell movement asking for these

specialty deals?

Farmers have obligations to produce

safe feed and safe product, which I truly

believe they all work within that guideline,

\'cause they know if they don\'t have that, they

won\'t be in business much longer. Should the

production of safer food be at any cost? And

that was raised.

It was interesting, as we went

through all of these, one of \-- the

facilitator, the young girl that was there

after it was over, we asked her, would she now

go out and eat meat after hearing all the

different topics? But yes, she said she would.

(Inaudible.)

MR. SAMPLE: No, I think the

discussion went real well. We had a lot of

participation around the area, and \-- Any

questions?

MS. DUNNAVAN: I, I have a

question. Randy, earlier in your discussion,

you talked about a standardized form. Can you

talk about that a little bit? Is that just \--

Is that just for the transportation piece, or

is this something that the industry would have

to check off, I\'ve done this, I\'ve done this,

I\'ve done this, or it \--

MR. SAMPLE: I think what they

were \-- we were discussing \-- and some of the

other ones that are in our group, correct me if

I didn\'t portray this right \-- was an SOP

standard form that a farmer or a small

operation could take and utilize.

MS. DUNNAVAN: Oh. Sort of a

fill-in-the-blank kind of \--

MR. SAMPLE: Right, fill in the,

kind of, blank.

MS. DUNNAVAN: Oh, okay.

MR. SAMPLE: Because it\'s gonna

be difficult to get that segment of the

industry to follow this without giving \'em some

help to do it.

MS. DUNNAVAN: Okay. Thanks.

MALE VOICE: Yeah. Randy, also,

I think we were looking at more in the

transportation side of things, where, right

now, when we call a supplier of ingredients and

say, Hey, you know, can you tell us what was in

that car, you know, something looked suspic \--

we, we get very little paperwork oftentimes

showing previous loads and all that type of

thing. If there was a standard form, you know,

within the industry that would automatically

accompany invoices, bill of ladings, whatever,

and that everyone would demand it and expect it

from any type of carrier, I think it would help

a lot.

MR. SAMPLE: Any others? One

more back (inaudible) \--

MR. WOODWORTH: Yeah. Rich

Woodworth, Food Animal Concerns Trust. We\'re a

consumer group, and we like niche markets, and

I\'d like to hear why it is you feel niche

markets would be hard to regulate or involve in

this program.

MR. SAMPLE: Finding those niche

markets, where they\'re produced, sometimes is

difficult. Does anyone else have any comments?

I think we felt like that they weren\'t well

known by the regulators or the states, how

these niche markets move in and out. And also,

the e-mail \-- the Internet, how does that

affect? Someone else?

FEMALE VOICE: Yeah. Okay. I

just wanted to make the comment in, in response

to, to your comment over there. AFIA\'s

Ingredient Suppliers Council has developed a

transportation form that ingredient suppliers

are to use for \-- or to make sure for

restricted products, as well as other

ingredients. It\'s not just to those products.

And that form requires them and the

transportation company to identify what was in

that \-- in that truck, or whatever, prior to

that shipment, and they have to sign off on it.

So if \-- You know, if ever you \--

MALE VOICE: (Inaudible)?

FEMALE VOICE: And if the \--

MALE VOICE: In other words,

if \--

FEMALE VOICE: Well \--

MALE VOICE: \-- (inaudible)

doesn\'t supply (inaudible)?

FEMALE VOICE: Hopefully,

they\'re not gonna use \'em, but I\'m not naive

either. But on the \-- It is a little more

controllable on the truckers, I think, than the

rail.

MALE VOICE: I mean, we, we can

put things in place ourselves \--

FEMALE VOICE: Right.

MALE VOICE: \-- but there\'s

still that one (inaudible) where if there\'s no

(inaudible), I mean, there\'s nothing to

encourage them (inaudible).

FEMALE VOICE: Right. I know

some of the ingredient companies have reported

back to me that they \-- And I know this is just

some, but they reported back that they

absolutely will not use that truck unless those

people sign off on it, so . . .

MALE VOICE: The trucks

(inaudible).

FEMALE VOICE: Yeah, exactly.

MALE VOICE: We addressed that

same issue in our group, 3A, and most of the

feed mills today have a requirement that

truckers, when they come in, they sign off that

the truck has been cleaned and so forth, but I

think we went along with that same point, the

problem being that a lot of \'em will say

anything to keep their job. In fact, we had an

example within the group where one recently

just lost a job that refused to do that, told

the truth. So that you need a regulation to

back it up, to put some teeth into it, and

unless you have that, we continue to have an

exercise that really doesn\'t really guarantee

safety.

Also, in the area of SOPs, 3A

addressed that, and one of the things that we

got into on that was that SOPs would be needed

for the safety issues, and the point being

that, well, maybe you don\'t need \'em for the

nonsafe issues, but all in all, when you end up

with it, you end up with a total written

package, because it\'s \-- you can\'t really

differentiate.

MR. SAMPLE: To answer the

gentleman\'s question about the niche markets, I

think the group felt like there was just lack

of knowledge, what those products were and how

they were used, so . . .

Any other questions?

MR. BRIGHTSMAN: Yeah, Randy.

John Brightsman.

MR. SAMPLE: I didn\'t do it,

John. Wasn\'t me.

MR. BRIGHTSMAN: I got a

question for both, both groups, as far as

the \-- I heard about the SOPs and whether there

was any discussion about AAFCO\'s checklist \--

MR. SAMPLE: No.

MR. BRIGHTSMAN: \-- whether

anybody is using that \--

MR. SAMPLE: It wasn\'t brought

up at our group.

MR. BRIGHTSMAN: \-- whether \--

You know, that would be a good starting point,

\'cause that was \-- excuse me \-- that was a

voluntary program that AAFCO had worked on with

the industry to come up with something that

would provide guidance and so forth.

MR. SAMPLE: Well, again, I

think we\'d look at it as far \-- It\'d be an

education process. Has that gotten out to the

farm level or to the small production area,

that this is available? It\'s almost felt like

it\'s just, basically, an education process.

There are forms out there they can utilize.

People just don\'t know where they\'re at, how to

use \'em. Okay.

MR. BRIGHTSMAN: Thank you.

MR. SAMPLE: And I guess I got

my immunity stick; right, Bruce? Did you

negotiate that, too, for our next inspection?

We can get an immunity stick? Okay. I can see

we\'re all together. Whap. No.

MR. WILSON: Okay. We\'re a

little bit ahead of schedule, which is great,

because then we can make sure we have plenty of

time for questions and answers at the end. I

think now we\'re gonna go ahead and take our

30-minute break. I\'ve got about \-- a little

past 9:15, and so about a quarter \'til 10,

we\'ll get back and get started. They have set

up for us, I think, just the \-- As you go out

the door to your right. So 30 minutes.

(A break was taken from 9:15

a.m. to 9:45 a.m.)

MR. WILSON: \-- a little bit out

of order on the way \-- the 1, 2, 3, 4, 5

scenarios and jump straight to 5, which is risk

and risk-ranking method. If we could, I\'d like

the reporter for Group 5A, which is Judy

Thompson, to come down and take the podium.

JUDY THOMPSON, GROUP 5A

MS. THOMPSON: Thank you. I\'m

Judy Thompson from the Canadian Food Inspection

Agency, and it\'s a little bit \-- I was a

reluctant reporter, as well, I must say. I

tried a new tact. I kept my mouth shut for

five minutes, and I got nominated instead, so

that didn\'t work.

I want to put on my other hat just

for a quick second. I\'m the president-elect

for AAFCO, and I wanted to thank the FDA, on

behalf of that organization, for inviting all

the states to participate in this very exciting

meeting about an, an initiative that we\'re all

very interested in participating in, so thank

you very much for putting on this meeting. It

was great.

So the group I was in was very \--

What\'s the right word? We were very quick in

getting our work done, so we had some extra

time and put together a PowerPoint that sort of

summarizes our discussion. So our first

question \-- And I thank Dr. Hooberman for his

help, \'cause if he wasn\'t in the room, I\'m

quite sure that we\'d still be there talking

about the risk-ranking method, \'cause we had a

lot of questions, and he was very, very helpful

in, in helping us all see the light. So I

think if you could send him around to a variety

of places and he could describe it all to

people, that you would be very well served by

that spending of that money, as well.

And so the first question was, was

our explanation of the risk-based \-- ranking

method understood, and how can we improve its

clarity? And the answer is on the next slide.

I think the answer to that first question is

pretty obvious, that \-- We, we spent about 40

minutes talking about things before we actually

got to answer the question, so I think the

answer was, kind of, no. We more or less

understood what was going on with the process,

but we didn\'t really know what other things

might be considered besides science. Was

politics in there? Was there economic impacts?

Were we concerned about the environment? How

was that all gonna impact on the final ranking?

So there was a lot of, I guess, uncertainty

about what that actually meant. And I think

the thing that we all sort of felt that would

have helped is if we had a couple of examples

of, of common feed ingredients and known risks

and had put them through the process, and we

could look at their relative scoring, that we

would have an understanding of sort of how

something that was pretty uncommon, that had a

big impact, or whatever, would look and what

that number would be, and so we did sort of

evaluate whether or not it made sense,

so . . . That would be our suggestion.

And we actually talked about, maybe,

corn and aflatoxin as being a good example,

\'cause you look at, sort of, maybe, either

high-risk years or high-risk situations versus

kind of a normal situation and give a

comparative rating, and that would give people,

I guess, more of an understanding of what was

going on and some comfort with the whole

process.

So the first \-- The second question

was: Do you agree with the risk-ranking

method? And our answer was yes. It looks like

it was conceptually sound, and again, just felt

we needed to see that in action to make a final

determination, but it looked like it was the

right way to go.

Third question was: Do you agree how

\-- with how we plan to use the risk-ranking

method? And yes, we did agree with that, and

we felt that \-- again, that the use of the

system needed to be based on science, not on

politics.

The fourth question: Are there other

methods other than risk ranking that should be

considered for prioritizing these hazards, how

they should be addressed, and what are those

messages \-- methods, and what are their

advantages over risk ranking? That was a bit

more difficult. We kind of went through a

process, and luckily, we had a break right

then, and we had asked Dr. Hooberman to think

about some ideas of things, and then he came

back and told us he wasn\'t allowed to talk to

us anymore, and we told him that that wasn\'t

really \-- wasn\'t really very helpful, so \--

\'Cause he had been informed that he was

supposed to be a listener and not a

participator, and we said that he wasn\'t, sort

of, taking over the group, so it was all right

if he talked, and so we had a bit of a chat.

And then somebody brought up the

fact \-- We had talked about \-- Most people

could probably come up with what they thought

were the five biggest risks based on their

experience or based on things that they \--

suppositions or whatever, and we thought it

might be a good idea to go out to the various

state regulatory officials, the stakeholders\'

industry groups, the farmers, and just ask them

what they thought the top five were, kind of

look for some common elements there, and we

felt there was also a lot of information out

there. People are testing for things and

looking at things, and they\'re most likely

looking for the things that they think are

problems so they\'d have a lot more information

on their top five than other things. And if

there was a way to collect all that

information, maybe have an on-line database on

the FDA Website, where people could just go and

enter their data sort of anonymously, and then

it could all be there as a \-- sort of a hazard

database or a risk database that we could use

long term. There was some \-- We\'re not, I

guess, all naive enough to think that everybody

is gonna go there and dump all their

information onto this Website, but there was

thoughts that if it could be anonymous, that

that might be an option.

And then the last question was: We

have modified the definition of \"risk-based.\"

Is the new definition more understandable?

And, I guess, given the fact that there\'s four

bullets there, the answer to that question,

again, is no. We felt that you need to keep it

simple, and you shouldn\'t define another thing

in the \-- in the definition for something else.

If you\'re gonna define \"risk,\" you can have two

separate definitions. Define \"risk,\" then

define \"risk-based,\" so don\'t put them two \--

the two things mushed together in one

definition. And we also thought that having

the third sentence, which talked about how are

we gonna use the risk-based, was really

unnecessary in the definition, because a

definition is just that. It\'s supposed to

define what it is, not necessarily how it\'s

gonna be used.

So that was our thing in a nutshell.

Sorry it didn\'t take 20 minutes. But we really

had a good discussion, and if anyone else in

the group thinks that we missed anything in our

synthesis of all the spreadsheets and flip

charts, please speak now. That\'s it. Thanks.

MR. WILSON: Are there any other

questions for (inaudible) at this time? Okay.

Then let\'s move on to \--

MALE VOICE: (Inaudible.)

MR. WILSON: Oh, we have a

question.

MALE VOICE: Well, it\'s not a

question, just a further comment. In the

group, we also spent some time discussing the,

the dynamic that who defines the risk often

will determine the level of the risk and the

nature of the risk, and we talked about, you

know, the industry or consumers or public

health participation, and out of that, some of

us were encouraging that the process do include

risk setting involving all those segments,

particularly public health.

MR. WILSON: Thank you. And now

the next presenter is Mr. Charles Breen from

our Seattle District Office.

CHARLES BREEN, GROUP 5B

MR. BREEN: Good morning, and

thank you. First of all, in our group, as you

can tell from the very beginning, more no than

yes, yes, it\'s clear. We didn\'t ever really

come to a consensus. We had to use diplomatic

speak, a full, frank and vigorous discussion of

the questions and issues. And I\'m going to

refer any difficult questions to legal counsel,

whom I have just spotted in the group here.

For the first question: Was the

explanation of risk ranking understood? Well,

some of us thought we did; others disagreed.

The majority opinion was no, it\'s not well

understood yet, and as mentioned in the earlier

5A group, some examples would help.

I won\'t just be reading all of this

because you can do that as well as anyone, and

I know that farmers do read. They just may not

want to pay attention to what they are reading.

The, the question of risk-ranking

method really was a difficult one to come to

any consensus among us, because the vigorous

discussion was \-- Well, there were too many

unknowns yet: the way it was going to be used,

how it would apply to specifics, in how much

detail would it be applied. These kinds of

things are issues that, I think, the Center for

Veterinary Medicine would be well advised to

explore and provide more information to the

stakeholders on how to \-- or how it is intended

to be used.

The second question of, Do you agree

with the risk-ranking method? Well, it got

tied up with the first question and the third

question, also. From the industry

representatives, the answer is pretty much no,

but a lot more data is needed. The idea of,

you know, assigning each ingredient an impaired

risk ranking, that becomes an enormous task

when you have to cover the whole gamut of

potentials that \-- Other variables, would they

be considered? The comment was made, and it

appeared to be one that was broadly accepted,

that, in many cases, feed is not the problem.

The control mechanism should not be applied in

feed when it might be applied much more

economically and effectively at some other

point in the process, between farm to fork.

The industry acknowledges that a lot

more scientific data is needed, a lot more

public scientific information. There is a

great deal of scientific information that is

held by industry but is not shared with FDA

because we, FDA, cannot keep that information

private. There is the Freedom of Information

Act and, also, the public records. The data

that is held by industry is used by industry in

its quality assurance programs, and I\'ll touch

on that a little more later.

The third question: Do you agree

with how FDA intends to use risk-ranking

method? Well, no. Whether it was top to

bottom would be preferred to bottom up, as long

as there\'s significant data to assess the risk.

A broad-based \-- A broad-based research and

comprehensive data set is needed to provide

information necessary to provide a good, solid,

risk-based system.

We also acknowledge that there are

other factors outside of scientifically

available data that drive FDA\'s risk-based

decision-making process. For instance, right

now, in this country, BSE is a very low-risk

problem, but it is a high priority for the Food

and Drug Administration. There are

nonscientific drivers that make it a high

priority for the Food and Drug Administration.

So how is this risk-based process

going to accommodate these nonscientific

drivers? They can be considered \-- called

politics. They can be called consumer

perception. Whatever it is, there are issues

that are outside of the probability and the

consequence matrix that are used for risk

determination. Risk ranking is just not

enough.

The fourth question: Are there other

methods for risk ranking that should be

considered? What and why are they better?

Well, again, we talked about risk in the

context of all three of the previous questions,

and some advice was suggested about focusing on

current programs to identify weaknesses that do

exist, a test pilot, you know, just to see how

it works, to say, Using this kind of ingredient

that would be used in this fashion, how would

this method apply?

There was a suggestion that the AFSS

survey the industry to see what programs there

are out there, and the programs that are out

there may provide those industry members who

used them with a competitive advantage, and

because of that, those industry members are

reluctant to share them because they could not

be kept confidential, and why tell your

competitor what you\'re doing to make your

product better when what you want to do is make

your product better so that it sells better

than your competitor?

The second part of that question:

No, no alternative methods currently.

And the last question: Is the new

\"risk\" definition more understandable? Well,

yes. It\'s as clear as the first one. There

wasn\'t much discussion in our group as to

whether one was any better than the other.

There were some other currents during

this discussion, this full, frank and vigorous

discussion that we had \-- that we had, that I\'d

just like to mention, that will affect how we,

FDA, deal with the question. One is that

industry is rapidly consolidating. From a

regulator\'s perspective, which is what I have,

to me, that sounds like a moving target, and

the government bureaucracy always has a hard

time hitting a moving target.

Likewise, there are industry

practices that are rapidly changing \-- not

necessarily improving, but changing in response

to market demands. Pull-through, I think, was

the term that was used, where a big customer

says, I want you to . . . Whether or not it

makes sense, if you want to keep that big

customer, you will do whatever that is the

customer asks for. Although the big customer

was not named, I know that Wal-Mart does a lot

of that. They don\'t buy that much animal feed,

but the same kind of practice, where they say,

you know, Do this for us so that we can say

whatever to our customers.

And not only individual pull-through

for the market, but other governments. For the

export industry, some countries have what

amount to \-- well, I hesitate to call it

nontariff trade barriers, \'cause they apply to

everybody, but they\'re certainly trade

barriers.

And there is also, at times, a

competitive advantage to having a quality

system that\'s better than the other guy\'s. As

I mentioned just a little bit before, one of

the reasons why industry \-- some industries are

reluctant to share with the government what it

is they\'re doing to assure quality is, when

you\'ve built a system that\'s working and you

have a brand-name product in the market, you

don\'t want your competitor to be able to

piggyback on the benefit of that experience,

and that this is not just a competitive

advantage, it is at a competitive disadvantage

to be publicizing those details.

Now, are there any questions that I

need to refer to counsel?

MS. DUNNAVAN: (Inaudible.)

MR. BREEN: Gloria?

MS. DUNNAVAN: (Inaudible.) I

don\'t know if you need to refer this question

to counsel or not, but I just \-- Could you give

me a little more explanation? At the \-- sort

of at the beginning of your discussion, you

talked about that maybe something would be \--

Let\'s say I\'m a finished-feed manufacturer, and

there\'s an issue that I\'m concerned about, but

I may not be the one that has to deal with

that. It may be somewhere else in the \--

MR. BREEN: Yes. Let me get to

an example \--

MS. DUNNAVAN: \-- farm-to-table

continuum.

MR. BREEN: \-- that was

discussed. Microbiological quality of animal

feed. What data is there to suggest that the

microbiological quality of animal feed

contributes to food-borne illness in humans?

Salmonella in chickens. Well, if you cook the

chicken, that kills the salmonella, and that if

there is salmonella in chicken but it wasn\'t in

the feed, how did it get there? It could well

have been feeding practices at the animal

producer. It could have been flies that land

on the manure and then onto the feed. If there

are other control steps, other than feed-control

steps, that might control that hazard better

and more effectively than just providing a

pasteurized feed product to an animal producer.

MS. DUNNAVAN: So under that

sort of scenario, then, I would \-- If I \-- If

I\'m thinking it\'s better control somewhere

else, than I just \-- I wouldn\'t deal with it

(inaudible)?

MR. BREEN: That \--

MS. DUNNAVAN: I\'m just trying

to make sure I\'m understanding the concept.

MR. BREEN: Well, the \-- Please,

any of the group pitch in, as well.

MS. DUNNAVAN: Sorry. I\'m not

picking on you, Charles.

MR. BREEN: The way it was being

presented \-- The way it was being presented is

that for that particular scenario, the cheapest

way to control human illness is to educate

consumers to cook the chicken well and use

separate cutting boards, or whatever, and not

cross-contaminate it in the kitchen with the

chicken and the raw vegetables on the same

cutting board, that sort of thing, that that

works and is cheaper and more effective than

whatever we might want to spend on feed

controls.

MS. DUNNAVAN: Okay. Thank you.

MR. BREEN: Anyone else? Thank

you very much.

MR. WILSON: All right. Now

that we\'ve finished with Group 5, let\'s jump

back to Group 4. Would the spokesperson for

Group 4B, Dan Danielson, please come up. Group

4B \-- or Group 4 is brief \-- is discussing

regulatory oversight.

DAN DANIELSON, GROUP 4B

MR. DANIELSON: Or better known

as cart way before the horse. I think once

this comes into focus, we could be better

served to make recommendations on an

enforcement strategy.

We had a good group, as well, very

diverse, very participative, except for the

point when they chose to elect a spokesman, and

then the patterns in the walls and the carpet

and everything got real interesting, so I guess

I was anointed as being from the Volunteer

State and should keep up with that tradition.

As far as the identified gaps for the

regulatory oversight, the first one we had a

little trouble with only because we think

that\'s the gap and the solution all in one, I

guess. Currently developing a risk-based

inspectional approach, that\'s a gap, and I

guess the development of such is the solution.

No. 2, I think we had a spirited

debate about, as was said. Not quite the same

words the last speaker used, but there\'s a

couple things we wanted to take exception to.

First of all, the statement that we focused

principally on commercial medicated feed

industry is true to an extent, but particularly

in my state, we have focused on feed

manufacturers. Our, our FDA-licensed mills in

Tennessee keep dwindling. We \-- We\'re down to

about eight or nine, something like that. We

have about 150 manufacturers, so we\'ve been

looking at manufacturers in general.

Secondly, the, the statement about

some on-farm operations are making more feed

than most commercial feed companies, well, I

don\'t know. I guess that could be true

somewhere. Certainly not in Tennessee. Some

of our integrated outfits may make more feed

than some of our smallest mills, but I\'ll

guarantee you they do not make more than some

of our biggest manufacturers. So that may be

true in some states, not, not particularly in

all.

Let\'s see. Going to 3 \-- Oh, just to

say, we basically agreed with all the gaps in

some fashion or another. The third gap of

insurance competency and proficiency with state

and field inspectors, that\'s very admirable.

We want to do that. We want to do that in all

of our programs to make sure our inspectors

know what they\'re doing, they\'re capable, they

understand the, the industry and what we\'re

doing. It asks for traditional novel

approaches providing training. Well, maybe

we\'ll want to take a step back, and maybe my

bias is dealing a lot with EPA programs. We do

a lot of hands-on training, a lot of regional

training for inspectors via EPA. I think we

like that better than these computer modules.

I don\'t know how it works for your field staff.

I have field staff. They\'re very proficient in

working through computer modules. I have

others that it\'s extremely painful for, and I

don\'t know what they really get out of it. So

again, I think some face-to-face, hands-on

regional training by FDA for state inspectors

would be great, and again, prefer that over

computerized modules.

I think the gap that, that we

identified in No. 3 was, Well, what about the

industry? How are we gonna get the word out to

industry? And I think big industry, the, the

larger players, the more responsible industry

are in this room. They get it, or they want to

get it, or they want to fight it, whatever, but

they\'re in the game. It\'s Billy and Bubba out

in Podunk, Tennessee, that we worry about. How

are we gonna get the word out to them? They

probably do not belong to AFIA. They may not

belong to any trade association. Perhaps

extension would be a way to get to some of

those folks, but we think that\'s a gap. How

are we gonna get the word out to industry and

especially the smaller mom-and-pops or Billy

and Bubba out there running a little bit of a

mill in a Quonset hut?

And also, as part of my agreeing to

be the spokesman, I was assured that I would be

backed up \-- it remains to be seen how far

back \-- by my \-- by my group as far as if I

miss some salient point here.

I think one of the gaps, as far as

the Inspection No. 2, is this whole issue of

what states have on-farm authority, to what

extent do we have on-farm authority. FDA

claims to have on-farm authority. Do they have

the authority if none of these products are

shipped interstate? So I guess the solution

for that is, is, we\'d like to see AAFCO come up

with some language in a model bill for on-farm

authority. The other choice that some states

have done is go out there on that limb by

themselves, but I think we\'re better served to

have a model bill, have some framework and have

something that we can go to our local

legislators and administration, say, Yeah, this

is the thing to do. We have a model.

Everybody else is doing it, so we need to do

it, as well.

One additional gap, I think, that we

identified on this whole manufacturing process

is we cannot keep our \-- we can\'t lose sight \--

take our eye off the ball or the finished

product. You know, quality is, is an important

thing. Quality is really the genesis of a lot

of our feed regulatory programs. As we know,

these feed regulatory programs go way back in

states, and again, foundation is consumer

protection. While process for safety, we feel,

is very important \-- I don\'t think we can

forget that, and within that, we still have the

issues of imported feeds. You know, that was

mentioned in one of the other presentations.

There may be firms, we can\'t get to their

process, so we have to rely on looking at their

finished product. Frankly, it\'s easy for us to

look at finished product for quality, look for

some contaminants and things of that nature.

There\'s this whole Internet thing. We\'re not

gonna be able to get to processes there, so

again, that\'s a place where we need to focus on

the \-- on the end product and not just the

process.

This is a little disjointed. It\'s no

fault of our recorder, Andy Gray (phonetic).

He did a \-- He did a \-- He put a good effort

into it, but our, our discussions were so

freewheeling that I think it \-- we had a

little, little trouble keeping on, on target.

We think there\'s a component here for

self-inspection programs. I, I hesitate to use

voluntary self-inspection programs. I think

there should be self-inspection programs with a

regulatory oversight. Not \"I,\" \"we\" think.

There should be self-inspection programs with

some sort of regulatory oversight component.

Back to the, the gap on

record-keeping of, of transportation. We

talked about trucks and rails. Nobody has

mentioned barges. I think barges come through.

And again, I think \-- we think that there\'s the

potential for some sort of self-inspection

program with regulatory oversight.

Now, to get to the, the, the other

questions, how, how may the AFSS affect

federal/state relationships? Well, it depends.

On one hand, you could see it as an unfunded

federal mandate. Here I am with my pesticide

bias. In other words, if we\'re asked to go out

there and do a whole bunch of firms that we

don\'t normally do \-- I mean, again, we focus on

manufacturers \-- commercial feed manufacturers.

If we start going on farm, we start going to

dairies, the integrators that are not FDA

licensed, well, we\'ve just opened up a whole

new clientele for us, and that\'s not

necessarily a bad thing, but again, from the

state that\'s probably doing about all we can do

with what we got, what\'s going to give \--

something\'s got to give.

We \-- You know, of course, there is

always the money issue. You know, I think it\'s

only fair to bring it up. You know, what, what

level of funding are we gonna see \-- increase

of funding for doing increased number of

inspections? Perhaps FDA ought to look at the

EPA model and look at performance partnerships,

grants with states, instead of paying by

inspection or these partnership agreements,

whatever they are. Doesn\'t amount to a whole

lot. If we\'re gonna get into this, then, to a

much larger way, I think it\'s something that

must be addressed.

Question 5: Should regulatory

programs focus solely on risk? Well, no.

Again, back to what I said, we can\'t take our

eye off the ball on finished product. And

again, maybe it\'s just from me coming from a

production background, but if you buy

36-percent protein feed, I would think that you

pretty much expect somewhat close to that. I

think the consumer protection part of it is, is

still vital and still real, and I don\'t think

that the safety \-- although it\'s an important

component, we don\'t want it to overshadow the

quality assurance and the

quality-of-the-product issues.

If process controls are established

for on-farm manufacturing, what would

regulatory oversight, such a program, look

like? Well, one of the wags (phonetic) in our

group said platypus. That\'s probably what it\'s

gonna look like. In reality, I think the only

way it\'s going to work is we\'re gonna have to

have a defined implementation schedule, put

this in place over time. An example might be

the first year would be completely outreach and

education; second year, you might go to some

compliance assistance, actually visiting these

firms, looking at what they\'re doing; and then

lastly, going to a compliance program. But

again, there\'s got to be some time and some

effort spent on putting this in place before we

go into enforcement. And again, as it says up

there, lots of outreach.

And then it was suggested that the

risk-based system \-- And I think that was

mentioned in some of the earlier ones. There\'s

some risk-based systems already out there, and

perhaps we want to model, model, model this

after that.

But basically, assistive controls

must include economic protections to fulfill

state statutory mandates and provide consumer

protection, as well as feed safety. I don\'t

think we can forget about that.

Okay. What\'d I miss, y\'all? Is

there any questions? All right. Thank you.

MR. WILSON: All right. Next,

next on the program would be the presenter from

Group 4A, which is \-- I\'m sorry, your name,

ma\'am? Oh, no. This is Marlene, Marlene

Petersen.

MARLENE PETERSEN, GROUP 4A

MS. PETERSEN: I wanted to thank

the FDA for the opportunity to participate in

this process, and since there is a lawyer in

the room, add my legal disclaimer that in no

way should my comments be construed as an

endorsement.

And for our group, we essentially

agreed on the gaps, and we spent some time

talking about them from the standpoint of, of,

you know, what we agreed \-- We got kind of

mixed up between the agreement \-- where we \--

the gaps and where we thought there were some

misses. In essence, if there is gonna be an

inspection program, we did agree that it should

be a risk-based system, but there was some

concern over the BSE inspection process, the

guidance, because the risks are different in

BSE, and \-- You know, whether or not that was a

good example or not \-- You know, it\'s probably

the only one out there, but . . . We felt you

need to develop a separate risk base for feeds

and foods and that the risk-based model was

definitely the way to go.

We did agree that the \-- you know,

the predom \-- preponderance of the inspections,

the regulatory focus in the past, have been on

medicated feed and, to some extent, feed

manufacturers, and that there is a component

that really needs to be brought in.

Transportation was discussed extensively.

There are \-- I don\'t think there\'s anybody

who \-- in the industry who doesn\'t feel that

transportation is a problem for us, and if

you\'re gonna have a comprehensive program,

you\'ve got to deal with the transportation

aspect and also the on-farm aspect.

It was also brought up to not

overlook mobile mixers. Apparently, there are,

in some parts of the country, people who get, I

guess, old cement trucks and drive from farm to

farm mixing, and I\'m pretty certain those

mixers have been validated, so I wouldn\'t be

concerned about it.

There was a lot of discussion about

the size and scale of the term \"on farm,\"

because \"on farm\" can go from a huge integrated

operation to, you know, a very, very small

hobby farm, which may have one or two animals

on it, and we felt that the term \"on farm\"

needed to be, I guess, broken out to have more

definition to it, because if you\'re gonna set

up a regulatory oversight program and you have

a category for \"on farm,\" you can\'t really deal

with integrators the same way you\'re gonna deal

with, with hobby farmers, so there needs to be

more classifications, more definition within

that.

There, there was a lot of discussion

on the FDA industry education materials.

There\'s gonna be a component here that is going

to require a huge amount of education. There

is \-- There are people already, you know, in

the regulated industry who still need more

education, and as you break into the on-farm

component, the transporters, the ingredient

suppliers, there just needs to be a huge amount

of education that goes on.

And then lastly, it\'s the gaps, and

this is the one that I really struggle with,

is: How is the FDA ever going to identify the

inventory of facilities? farmers? truckers?

railcars? I don\'t know how \-- How, how is that

list of places for inspection gonna be

developed? I mean, where are you gonna get

that information from?

Our Gap No. 3 was, you know, that

that training was needed for proficiency and \--

of inspections, and we feel added to that

should be uniformity. When an inspector comes

in the door \-- And I realize there\'s gonna be

some variation in how an inspector \-- or an

investigator inspects, but when an inspector

comes in the door, there should be a standard

to which that investigation or that inspection

is done. There shouldn\'t be a huge amount of

variance, you know, from one part of the

country to another, from \-- whether it\'s a

state or federal, federal inspection, if it\'s

being done under the federal contract. There

shouldn\'t be that kind of variation.

And solutions. One of the things

that we discussed from the ingredient side \--

or from the \-- I\'m sorry \-- receiving side is

that industry could require metal seals on all

receiving vehicles, whether it be railcars or

trucks. We talked about needing more

educational materials. Currently, they\'re

broad-based, but we need some very specific

educational materials. One of the things that

was commented on was the, the BSE video for the

trucking industry. You know, we\'d like to see

that available. You know, from an industry

standpoint, we would be very open to having the

video, you know, in our facilities and playing

it for truckers while they\'re unloading or

loading, as the case may be.

Regulatory oversight and field

presence. Some of the, the, the issues with,

you know, varying training and varying levels

within inspectors or investigators could be

helped with some regulatory oversight and field

presence, and I believe the FDA said they\'re

already starting an auditing process to try and

provide feedback to their investigators in

order to, you know, try and even out that

inspection process.

Consider third-party certification

program and or self-inspection programs with

some level of regulatory oversight. The fact

is, if you expand what is being done, you know,

to include a larger scope, resources are an

issue, and one way of redirecting the FDA and

state resources might be regulatory oversight

and acceptance of some type of third-party

certification program and/or inspection

program. And we need more education through

land-grant colleges, extension agents, producer

groups for programs, to all program areas \--

the farmer, the hauler \-- and working through

state groups and allied industry associations.

Question No. 4 dealt with the

relationship between state and federal if AFSS

becomes a federal regulation, and from \-- There

was a lot of discussion, you know, particularly

with regard to the state component, and they

felt pretty strongly that if AFSS becomes a

federal regulation, then money would be needed

to fund state activities and to really try and

get information of what \-- you know, how the

states are gonna react to this and what they\'re

gonna do. We felt it was important that

individual state regulatory officials, you

know, provide input to the FDA as to \-- \'cause

states vary, the level of funding, what they

do, what\'s important to them. And there\'s also

some difference in regional parts of the

country as to what the issues are in that part

of the country. Mycotoxins, aflatoxin may not

be an issue in the Northeast, but, you know,

they\'re a problem in Texas in any particular

year.

And the big one was communication,

open communication between \-- from the FDA back

to the states, from the states back to the FDA.

There needed to be more, broader, open

communication on, on regulatory oversight and

more uniform compliance with FMD145 from

district to district, and this had to do

specifically with contact \-- contract

inspection reports and/or checklists. A

facility is supposed to get some type of report

back after an inspection has occurred, and, and

it appears that, in some areas, that\'s not

occurring.

Question 5 was related to, you know,

should a regulatory oversight program be based

solely on risk, and the answer came back, from

the state standpoint, that in a number of

states, that consumer protection component is

extremely important to the consumers and their

state and that it was essentially an impossible

sale, that they would not be able to

discontinue that component of what \-- the

services that they\'re currently providing, so

that it was gonna be necessary to have both a

consumer protection component in those states

and also an animal feed safety component. So

the recommendation was that, essentially, AFSS

should remain silent on, on that topic and

allow the states to make that decision as to

what their program needed to look like and what

they needed to provide to the consumers in

their state.

The last question was a fairly

difficult one, you know: What would an on-farm

inspection program look like? And this one,

until you know what it is, you know,

specifically you\'re looking at wanting to do,

this is really difficult to, to answer. The

idea was, with a definition of \"on farm\" that\'s

a little more expanded, could be devised for

the various types of entities. You know, for

instance, you know, a hobby farm feeder would

be a different type of classification for an

inspection as opposed to an integrated

operation. And there\'s just \-- You know,

you\'ve got on-farm mixers, sale barns. You\'ve

got, you know, dairies. You\'ve got mobile

mixers, integrated operations, cattle feedlots,

et cetera.

We really didn\'t spend too much time

addressing this from the standpoint of \-- We

didn\'t happen to have anyone who represented

the on-farm component in our group and didn\'t,

didn\'t and don\'t really understand what it is

that is expected to be done, and you have to

know what you want to do before you can do a

regulatory oversight program for it. So we, we

talked about this one but really couldn\'t come

up with anything specific.

MR. WILSON: Are there any

questions of this group, or (inaudible) in the

group like to add anything? Gloria has a

question.

MS. DUNNAVAN: (Inaudible.) Can

you just give me a little clarification on the,

the discussion about the states not buying in

on, on some of this? I mean, was there some

discussion that, that the state legis \-- that

they\'d have to go to the state legislature, for

this \-- for this kind of system, or?

MS. PETERSEN: I think they felt

that \-- You know, and please correct me, \'cause

I\'m, you know, obviously, not a state

regulator, but they felt that their customer

base, their consumer groups, their farmers,

their, you know, producers, want and need that

consumer protection part of it, and for them to

change or delete or get rid of that component

in their program was gonna meet some

significant resistance within their

legislatures. Now, whether it\'s because

they\'re wanting to get something through the

legislature \-- I mean, these programs are

somewhat funded through that mechanism.

MS. DUNNAVAN: And was the

thinking that they would potentially have to do

that if \-- for an Animal Feed Safety System

to re \-- would replace that, or?

MALE VOICE: (Inaudible.)

MS. PETERSEN: Okay.

MS. DUNNAVAN: I\'m just trying

to make sure I\'m understanding the state

concern.

MALE VOICE: While they\'re

looking, Glo, let me chime in. I think, in our

state, our statute addresses commercial feeds

that are in channels of trade. Once it gets on

farm, and especially once it gets dumped in a

trough, I\'m not sure what our authority is.

And again, I think our solution was, perhaps,

work through it through AAFCO and the model

bill, and it potentially may require a

statutory change, at least in my state, to

ensure that we have clear authority and

clear \-- what would you say? \-- remedy, for

violations on farm, because this feed is not in

channels of trade, and we cannot use our

traditional hammer of stop-saling. You gonna

stop-sale it? It\'s in the trough. Big deal.

Okay. Can a state vet maybe quarantine some

animals and stuff? Well, maybe, but this is

all things that need to be fleshed out, and I

think that\'s where at least our group is coming

from.

MS. PETERSEN: Glo, the question

specifically was: Should regulatory programs

focus solely on risk, and how would a

risk-based approach affect economic protection

activities? So from the state\'s standpoint,

there is a component of the state programs now

which is based on consumer protection, and in

some states, they felt it would not be salable.

It wouldn\'t \-- You couldn\'t sell the concept in

their state as it\'s currently formulated.

MALE VOICE: Another aspect of

this, Glo, is that we\'re venturing into an

area, as Dan\'s already alluded to, that \-- We

\-- We\'ve traditionally done the feed mills.

We\'ve not had authority to go on farm, and some

people don\'t feel very highly about going on

the farms, not to even consider the volume of

farmers out there. You know, farmers are very

protective, and, and to get people coming onto,

onto their farm, we, as regulators, are gonna

have to sell this, not only to our superiors

but to the legislators, too, and I think this

is an issue that we would have to face on the

state level.

MS. DUNNAVAN: Thank you.

MS. PETERSEN: One more.

MR. SMITH: I have a question.

I\'m Kevin Smith of Division of Federal and

State Relations. I want \-- I was wondering if

the other Group 4 brought up this issue, and

one thing we failed to mention in this group,

4B \-- or 4A, rather, was the question of: As

this \-- As AFSS gets rolled out and we seek

input and feedback from the states, what would

be the most effective way of doing that? And

we asked \-- We kind of debated the question of

using AAFCO as a primary tool for sharing

information, and their \-- and the point was

made that it\'s probably best to get feedback

directly from the states \-- individual states

in the form of telephone calls, e-mails, draft

surveys, and make sure that it goes on an

individual basis. I\'m just wondering if the

other Group 4 discussed anything along those

lines.

MALE VOICE: Not really. Not

really.

(Inaudible.)

MS. PETERSEN: I \-- Do we have

someone from 4B who can answer that question?

MALE VOICE: (Inaudible) come up

in our (inaudible) were either via AAFCO for

input or individual states. I guess just me

thinking personally, either one would be fine,

I guess. I think when you go to individual

states, you\'re gonna have some, some \-- oh, I

don\'t know \-- vagaries to work through. You

know, we, we all may be saying the same thing

in a different way, I guess is what I\'m saying.

Teresa, any of the rest of our group

have any thoughts on this?

MR. WILSON: Okay. Thank you.

Moving on. I think we\'re \-- If I\'ve kept count

right, we\'re ready for Group 6, and we go ahead

and with Groups 6 \-- 6 has 6A and 6B, but

they\'re actually 6 and 7 because they have

different questions, so 6A can \-- could go

ahead, and then we\'ll have \-- They\'ll have the

\-- Each of them will have the full 20 minutes,

so . . . Thank you.

RANDY GORDON, GROUP 6A

MR. GORDON: Well, we had such a

cerebral group that it\'s gonna take two of us

to present our findings today. I\'m Randy

Gordon with National Grain and Feed

Association, and Liz Wagstrom with the National

Pork Board will be presenting the second half

of our report.

Our questions \-- Actually, our

presentation kind of divides naturally, because

our questions were kind of grouped into two

different sections. One was kind of asking our

group what we thought of the overall framework

itself and the components \-- the four different

components of the framework, and were there

parts we agreed or disagreed with or any gaps

or omissions from the components themselves

that we might recommend be included. So that\'s

the portion I\'m gonna touch on, and then Liz is

gonna respond to our thinking, within the

group, of some of the elements that relate to

the specific elements of what AFSS might be

able to do for, for different sectors of

industry.

I\'d like to thank Roger Osborne

(phonetic) for being our, our very good

recorder. I\'m gonna kind of synthesize the

comments you\'re gonna see on the screen a

little bit here in interest of time and maybe

to bring some concepts together a little more.

I think, within our group, there

generally was an agreement that FDA \-- that

this is a useful exercise and that FDA does

need to take a more comprehensive and science-

and risk-based approach to feed safety that is

more inclusive of all different sectors of

industry, including ingredients and

transporters. Those two came up in our

discussion.

Likewise, there is general agreement

with the broad outlines of each of the four

components that are in the framework from

within our group, although we did have some

specific areas with which we would recommend

some changes, and I\'ll touch on these as we go

through each of the components.

Consistent with the bottom-up risk

evaluation we heard about yesterday, we\'re

gonna start with Component 4, which has to do

with addressing the regulatory oversight issue,

and within our group, there was a, a strong

support for government-based inspections and

oversight, including those performed by the

states. There was a belief that the

government-based inspections do provide \-- and

oversight of self-inspections do provide an

objectivity and a credibility that\'s needed by

the marketplace, as well as by consumers, to

maintain consumer confidence; a belief that

this provides some uniformity and consistency

across states and regions, given proper

training; that it provides some consistency

between the approaches that inspectors take,

both federal and state.

There was this issue discussed within

our group about: How do we get more uniform

training of the inspection work force so there

is more consistent application of the \-- of the

standards and interpretation? There was a

belief that we can adopt a more risk-based

approach to inspections and fo \-- the focus now

being, primarily, on medicated feed, but we

need to take the cost-benefit-based approach to

this, too, that costs are not a nonissue as we

look to establishing a \-- establishing a

risk-based inspection program.

Concerning Component 3, which dealt

with the process-control issue for production

of feed and feed ingredients and mixed feed,

there was general agreement, I think, within

our group, with the importance of addressing

hazards that are shown through science- and

risk-based analysis to be important in

preserving human and animal health, but there

was a concern about the use of the term

\"process control,\" and Marlene touched on this

a little bit from the audience earlier today,

that that term carries with it a quality

control or, in some international circles, a

HACCP connotation that we don\'t think is what

FDA is really intending here, and that kind of

belies the flexibility that FDA is trying to

provide within this particular component of the

framework that would recognize other kinds of

quality assurance techniques like CGMPs, ISO,

standard operating procedures that companies

have and other quality assurance approaches

that may be more appropriate for different

sectors of the industry. That \-- And that we

do believe that these approaches should be

appropriate for the type and size of firms and

establishments that are involved in a

comprehensive approach, when you\'re running the

full range and gamut of different entities, and

that, that we, we think that this component

might better be titled SOPs for safe production

and \-- of feed and fee \-- ingredients in mixed

feed, so \-- to get away from that, that

connotation of process control.

There also was a concern that this

component might be too broad to be

realistically implemented, and there was quite

a bit of discussion in our group, particularly

in the on-farm situation, in that there is a

need, maybe, in, in those sorts of situations,

to enter into a more collaborative approach,

where we look at guidance and other kinds of

approaches to accomplish this objective.

On Component 2, which dealt with the

limits for animal feed contamination, there was

concern about \-- registered within our group

about the use of the term \"contaminant,\" given

the legal liability that this term conveys

regardless of what the risk ranking of, of the,

the \-- that a contaminant might be. We

discussed a lot of different possible

replacement terms, didn\'t really come to a

consensus on, on anything, but we were toying

around with things like \"foreign substances\" or

\"unwanted substances.\" You see a term \"toxic

residues level,\" and there was some dissension

on that particular term within our group, but

we do think that this word \"contaminant\" does

need to be discussed more, as this framework

moves forward, as to whether there might be a

better term used.

On Component 1, focusing on the

ingredients and the approval process, there was

a belief that the current AAFCO feed ingredient

definition process is, is a good one that needs

to be formalized and expedited so that there is

a more timely review of, of feed ingredients

through the, the IDC process within AAFCO, the

ingredient definition process, but that once

those definitions are replaced, they also need

to be enforced and that the enforcement

component on unapproved feed ingredients is

kind of a missing element right now that needs

to be addressed.

Finally, in response to Question 3,

are there major components or elements within

the framework components that might have been

missed? We came up with three that might need

to be looked at. One, we felt, within our

group, there might not be an adequate

recognition in the framework document currently

of the existing private sector quality

assurance initiatives, both in the commercial

setting, as well as on farm, with different

species groups that currently exist, and that

goes back to this comment about whether we look

at guidance or regulatory approaches as the

appropriate vehicle in the future.

A second potential area in the

framework that might need to have more focus,

we\'re not sure \-- and you\'ve heard this

discussed by some of the other reporters

already today \-- that there is an adequate

homework done in this document yet about the

authority that FDA and the states might already

have, under existing federal and state laws, to

conduct on-farm inspections, particularly for

cause. I think \-- We didn\'t have a real

thorough discussion of the kind of inspections

that we might be looking at on farm, but I

think the general \-- within our group, there

was a belief that a for-cause inspection might

be an appropriate thing, but to have broad,

regular GMP-type inspections on farms is really

overreaching in this area. But that factual

piece needs to kind of be filled in, we think,

to the framework as to what the existing

authorities are.

And third, before I turn it over to

Liz, we felt there was a need for more

collaboration between \-- within all sectors,

and that includes between different federal

agencies, a good example being the DOT\'s recent

final rule issued on the Safe Food

Transportation Act, where they call for MOUs to

be established between FDA, USDA and DOT on, on

enforcing the existing standards that USDA and

FDA have in place on transportation between

federal and state governments, through

different kinds of MOUs, and between federal

and state and the private sector, and that can

range from \-- the gamut of all the kinds of

areas that we\'re looking at addressing here,

from ingredients to commercial-manufactured

feed to specie and on-farm mixer-feeder-type

groups, as well as the transportation sector.

And we have in place some models that we might

be able to use in that regard, best-man \--

best-management-practice-type collaborative

agreements that have been worked on between

industry and FDA in the past, that might serve

as a vehicle to look toward as we move forward

in the future on that.

And to discuss the rest of our

report, I\'m gonna turn it over to Liz. Thanks.

MR. WILSON: (Inaudible) ask any

question \-- have any questions for Randy in

this first section or anything? Very good.

LIZ WAGSTROM, GROUP 6A

MS. WAGSTROM: Thanks, Randy. I

work for the National Pork Board. My name is

Liz Wagstrom, and as the regulated feed

manufacturers here that may not have a good

understanding of, of what we do on farm and

things like that, I just wanted to say, coming

from the pork producers, we know, as producers,

that we have a responsibility to provide a safe

and wholesome product, and that includes

feeding our animals in a way that does not

impact their health or the health of the people

who eat the product we \-- that we produce.

We definitely need to know and need

to be involved and need to correct anything we

do, via feeding our animals, that may impact

the safety and the wholesomeness of our

product, so we want to be at the table, we want

to understand where you\'re going with an AFSS,

and we want to make sure that we are able to

continue to produce that safe and wholesome

product in a way that is economically viable

for the industry.

Now, as I get to the rest of the

questions, our group had a ver \-- It was very

diverse. We had lots of ideas, and we put lots

of them just under questions that, maybe, they

didn\'t really fit, but we had opinions, and we

wanted them to be heard, so I\'m hoping that

they actually make sense when you see our, our

answers.

We talked about how the Animal Feed

Safety System could help you maintain and

create a level playing field, and it\'s

interesting, because whichever segment of the

industry you\'re at, you always think that

you\'ve got it worse than the guy either

upstream or downstream from you, but we did say

there are areas of the industry that, that

would be held to similar standards as the rest

of the industry, including from the very, very

beginning, whether it\'s the ingredient

manufacturer, all the way down to the end,

whether it\'s the producer that has a

responsibility and is responsible for the

safety of the product that they produce.

We also thought that you could help

level the playing field with a correctly

designed system by having clearly defined roles

and responsibilities among agencies so that

there was this \-- not an overlap or a

reluctance to step in when there is a problem

because nobody is sure who\'s got the authority.

We definitely thought that we

could \-- that it could help by assisting to

develop educational information, whether it was

sample SOPs or, you know, other information on

a, a feed safety system that could then be

distributed through the producer groups and

through the industry groups and become part of

their volunteer quality assurance programs to

really build kind of a, a culture of feed

safety as part of an operating practice. And,

you know, as an example, for many of you who

aren\'t familiar with the pork industry, in

1985, we had issues with, with violative

residues in our pork. As a result, Pork

Quality Assurance Program was developed. We

now have almost 80,000 producers that are, are

on \-- certified under Pork Quality Assurance,

and our violative drug residues are almost

nonexistent. They\'re very, very low. They\'re

well within the acceptable ranges. And there

are consequences, obviously, for the producers

who have violative residue. So that\'s just an

example of how a quality assurance program can

help address problems.

We definitely need \-- felt there was

a need for these agreements \-- along with

defining roles, the agreements between

regulatory agencies, and then also, the

regulated industry, as Randy mentioned with the

GMPs. Best done through collaboration and, and

planning rather than, perhaps, necessarily

increased regulation.

And then, finally, we all agreed that

each segment of the industry needs to assume

responsibility for the safety of their product.

Under Question 5, how can the Animal

Feed Safety System help you address risks to

human and animal health, one of the things we

thought is we, we are missing data, and the

development of risk systems and the whole

prioritization may help provide information to

feed segments about not only segments that

haven\'t had much attention, but also help them

identify where the risks enter their system,

where they\'re best addressed. Really help us

decide what risks are truly risks versus

perceived risks, what\'s real versus

theoretical.

And also, we really talked a lot \--

We had a \-- We got into a dioxin talk. It

sounds like a few other groups got talked

dioxin (sic), and help us understand: What\'s a

limit that, that really creates a risk, you

know? And do we have the data that says, you

know, If you have a foreign substance \-- which

we decided was better than \"contaminant\" \-- at

what level does it present a risk, and at what

level is it background? And, and that was

something that we felt was really missing.

There are now firms, if you test for something

and you find it at any level, then what do you

do? Is it a risk? Isn\'t it a risk? What do I

do with the product? How \-- Do I have to

report this to somebody? So that was something

we hoped could come out of the whole setting

the risk ranking.

By understanding what the risks are,

you\'re gonna able (sic) to prioritize where you

need to intervene. Is there a need for

intervention? Is there a need to protect \--

Will this intervention protect public health?

So we thought the risk-assessment portion of

the project, although it\'s gonna be the most

difficult, it\'s gonna be the most rigorous,

will probably create a lot of value, and it\'s

\-- The value it may create, to begin with, is

just identifying knowledge gaps and allowing us

to understand where we need to fill in those

knowledge gaps, and it\'s gonna afford a more

uniform approach to problem solving. If you

set up a hazard as a model and this is how

you \-- how you address it through the system,

then, as another hazard may be identified, you

have a model for a way to look at addressing

it.

We also thought that by having a

pro \-- you know, looking at the process

control, it may make manufacturers more aware

of their process, and it increases the

awareness of the issues. And, and then,

definitely, we talked a lot about the need for

collaboration to determine levels of concern.

Work with all the areas of the industry, get a

collaborative effort, get an agreement that

there is a concern, work through how to address

that concern, and that\'s probably a way to get

by and \-- rather than just adding on a lot of

regulation.

And again, this bottom one is kind of

a reiteration of our dioxin talk. We need to

understand what levels of risk exist when you

find something and, you know, have the data to

say, Here is an acceptable level or an

unacceptable level.

Then we got to talking about trade,

and started out, we divided it between domestic

and international trade, and under domestic

trade, we actually got to talking about

something that may not \-- that, that came kind

of out of the \-- you know, the blue \-- and I

don\'t know that it\'s been addressed with the

AFSS \-- was that perhaps that AFSS would allow

a regionalized approach to risk, and we had

examples, like, in areas. Blister beetle may

be a regional concern, but it\'s not in other

regions, so how does AFSS address, even within

domestic trades, the difference between

geographic regions in the United States?

We also talked about that by

preventing any health incidences that may, you

know, theoretically, come through animal feed

or possibly come through animal feed, we \-- Our

consumers assume we provide them safe food. We

want to maintain that assumption, and we want

to, you know, not have an incident that may

shake consumer confidence.

With international trade, we wanted

to make sure that with the new Codex

animal-feeding document, that we don\'t have any

sanitary and fido sanitary issues in exporting

meat if the AFSS is not in line with the Codex

document. And I\'ll put in a plug for our poor

quality assurance program. We\'re in the

process of rewriting it this year, and one of

the things we are making sure is that our PQA

program is going to be in line with that Codex

document so that we can document that we are in

line with that Codex document.

We also, though, when we talked about

international standards, wanted to make sure

that those were standards, that we tried to

meet, that were based on science, that were

achievable standards, not \-- We got into

discussion over who, who \-- certain countries

that say, This is what we do, but do they

really do it? And so we wanted to make sure

that we had standards that were scientifically

based and that were achievable and, and not

just a lofty goal that would be nice to meet.

And so that\'s where we went on international

trade.

We talked a lot about economic \--

Well, actually, we talked more about costs.

Economic benefits. We talked \-- did talk a lot

about: What is the cost \-- the risk versus

cost benefit, and is, is the money that you

might spend \-- and we\'ll get into this more in

the next question \-- to implement and comply

with such a program going to provide benefit?

And we felt very strongly that there had \-- at

least most \-- some of us in the group, felt

strongly that if you \-- you had to show a

benefit. You had to be able to say that if

we\'re going to go this extra mile, there is a

benefit to either animal health or public

health.

Again, we talked about maintaining

consumer confidence that is equal to

maintaining trade. Obviously, we don\'t want

our names in the newspapers, we, we don\'t want

our names on the \-- 60 Minutes, and, you know,

we have to provide a safe product.

We did think that by having a

system \-- an integrated system that had \-- was

risk-based and scientifically based, that if

something went wrong and you went back and you

said, Here\'s a set of \-- whether it\'s good

practices or whatever, and went back and

reviewed that product and how it was, was

produced and that it had been produced

following these good product \-- or good

practices, but it did provide a defensible

position, that you said, Here are the things we

did to assure safety, something went wrong,

we\'ll, you know, make \-- try to correct it,

make sure it doesn\'t go wrong again, but it\'s

sure a lot better to say, We had a set of

practices that we were able to show we

followed, instead of just saying, Well, we

threw a bunch of stuff in, and, well, something

went wrong. So that, that was the idea that,

you know, did provide a, a ruler to be judged

against, perhaps.

When we got to cost concerns, we got

pretty passionate, even though it\'s toward the

end of the discussion. There was no doubt

among the group that if you have additional

inspections, sampling, testing, record-keeping,

retention of samples, whatever, it will add

additional cost, and it\'ll add additional cost

in every segment of the industry. And so \--

And then our \-- The regu \-- The

inspectors and regulators in our group started

talking about their additional costs, including

equipment they might need as \-- in \--

disinfectant equipment, if they go on farm. Do

they need bigger cars or bigger vehicles to

carry the equipment? What are their safety

concerns on farm, including biosecurity? Once

you have been on a farm, do you end up having

to have downtime to shower, disinfect? You

know, you can\'t necessarily go from farm to

farm, or there\'s \-- At least most producers

aren\'t gonna like it if you go from one farm to

the next. So what is that \-- What is the

time \-- downtime you\'re gonna have? So there

were costs throughout the system, on all ends,

whether it came from regulatory or from

producers or from manufacturers.

It\'d be nice to think you can take

those increased costs and pass them on to

consumers. That\'s usually not reality in

agriculture, and if it is \-- would become

reality here, what does that do for the

consumers? We do know that anytime the price

of meat increases, that consumption does go

down in some \-- in most cases.

We also talked about the impact not

only to small producers, which is where I came

from, but also to, perhaps, the small feed

manufacturers. If there is increased costs,

increased need for \-- whether it\'s, you know,

specialized weighing or mixing machines or

whatever, it is likely to cause producers and

small manufactures to exit the industry. We\'re

consolidating rapidly, and this may increase

the, the rate of consolidation.

We definitely looked at: What are

your up-front costs for somebody? And I think

we talked more from a manufacturing point of

view, but it could be from a producer point of

view, too, for staff costs to train them on

sampling, on record-keeping, on doing

microbiological assays, et cetera. So we

looked at education and training. It may \--

After you\'ve gone through the process, that,

over time, you may recoup those costs, but it\'s

definitely looked at as an up-front cost of

education and training.

And then finally, if this becomes

truly regulatory based with a fine and

enforcement potential, there is the cost \--

potential cost down the road of financial

penalties, and that was probably the \-- That is

on the bottom of the list, \'cause that wasn\'t

our top-of-mind concern of cost but definitely

needed to be considered as a potential cost of

the program.

And the final question on how AFSS

could help us in other ways, we got back again

to where we really talked about: Will there be

improved safety? Does this improve safety? If

it improves safety, it improves safety at what

cost? And we really thought there needed to be

some risk benefit or cost benefit \-- or

cost/risk benefit assessment of what, what you

would gain in increased safety versus the cost

of implementing a system like this.

We did have \-- think there was a

potential to \-- Because this is a systems

approach and, and it would be throughout the

entire system, there may be a chance for

improved overall compliance, and especially if

it \-- you know, with the increased education

and putting it into quality assurance programs

and having, you know, a systems approach, not

from \-- just from FDA but from the

manufacturers and the producers. You know,

with their quality assurance program, there may

be an improvement in overall compliance,

although nobody could tell us that we had a big

compliance problem at this point in time. It

wasn\'t that we thought there was a big

compliance problem.

We thought that, perhaps, industry

segments that didn\'t currently have quality

assurance programs, if we worked with the

Animal Feed Safety System as part of a quality

assurance program, maybe, enticed to develop

quality assurance programs for their industries

or their segments of the industry. We

definitely thought that we, again, wanted to

stress that, you know, you needed to clarify

the responsibilities of all parties involved

and that perhaps defining the system would help

clarify those responsibilities.

And then we talked about, finally,

that there needed to be collaborative

development to improve communication among the

sectors and that we felt, in a \-- some way,

that collaboration was gonna be the only way to

really get buy-in to any kind of a feed safety

system that \-- You know, if all the people

aren\'t at the table, if they\'re not looking at

the impacts and the benefits to their portion

of the \-- of the feed chain, that it was going

to be tough to get, get, you know, a good

industry \-- or good \-- total buy-in, and we

felt that that way, you could look at \-- as you

worked with each segment, addressing risks in

the way that\'s most appropriate to that

segment.

And as a closing, I\'m just gonna give

you \-- tell you a little story of the Danish

pork industry, and I, I am very fortunate that

I get to go to Denmark, probably \-- at least

once a year since I started with the pork

industry, and many of you may know that Denmark

has got a \-- started out with an incredible

on-farm food safety program, and they\'ve

spent \-- They spend \-- still spend about 60

cents a pig on on-farm salmonella control, and

they\'ve got salmonella feed controls and things

like that.

And over the years, they\'ve very much

stressed a stable-to-table approach, as we do

farm-to-fork approach, and when we were over

there this last year and they started really

looking at the benefits of that approach, the

pork industry there said, Well, we\'re starting

to call it a table-to-stable approach now, and

I said, Well, that makes me feel kind of \-- a

little nervous, because that means everything

at the table is a problem at the stable? And

they said, No. What it means is we start at

the problems with the stable, and we go just

as \-- or at the table, and we go just as far

back in the system as we need to go to correct

the problem to make it safe at the table.

We\'re not assuming we have to go all the way

back to the stable.

So I think that as you looked at that

risk-based approach with an animal feed safety

system, as you look at that end product or the

end risk and go as far back as you need to fix

it. That\'s, that\'s my pers \-- That wasn\'t from

my group. That\'s my, my personal story about

the Danish pork industry, but I think we can

learn a lot from that.

I\'d be glad to take any questions.

Okay. Short. People must want to go home.

MALE VOICE: On this idea of a

risk-based system, you know, it occurs to me

there needs to be a baseline established to

determine what the risk is, and I\'m \-- It might

have been Dr. Grabers (sic) or one of the

earlier presentations, it was up there that

something happened in \'68, and something

happened in \'74, and then something happened in

\'83 \--

MS. WAGSTROM: Uh-huh.

MALE VOICE: \-- of national

importance. Well, to me, that doesn\'t

connotate (sic) a tremendous amount of risk,

and kind of makes you wonder.

MS. WAGSTROM: Right.

MALE VOICE: And lastly, just

quickly, I wanted to thank Randy for bringing

up this whole idea of the unapproved

ingredients. Seems to me also that as long as

we\'re allowing unapproved ingredients in feeds,

that\'s a little bit contradictory to an overall

feed safety system, and \-- Anyway, just a

comment. Thank you.

MS. WAGSTROM: That\'s one of the

things we thought with the whole risk-based and

risk assessment, is you\'re going to help,

really, identify what truly is a risk and also

identify your knowledge gap, so that, that was

one of the things we really thought was

important.

MR. WILSON: All right. For \--

Our last group is Group 6B, and if you\'ll

notice, when we\'re going through here, that,

that Questions 1 through 4 on Group 6A and 6B

are basically the same, but 5 through 8 are

different. So 6B, if I understand, is Bill

Grande?

MR. GRANDE: That\'s fine.

MR. WILSON: \"Grand\" (phonetic)?

MR. GRANDE: \"Grandy\" is fine.

MR. WILSON: \"Grande\"?

\"Grandy\"? Okay.

MR. GRANDE: Yeah. Thank you.

MR. WILSON: Grandy/Grande \--

MR. GRANDE: Grande, yeah.

MR. WILSON: \-- tomatoe/tomato.

MR. GRANDE: There you go.

MR. WILSON: Very good.

BILL GRANDE, GROUP 6B

MR. GRANDE: I don\'t do very

well behind a podium, so I\'m gonna be out

front. And these groups and sessions that are

put on by the FDA are certainly appreciated,

and I appreciate being here. While we do

participate in these, we all have jobs, and I

was, unfortunately, delayed in getting here, so

I don\'t have any notes, so I\'m gonna have to

work off the PowerPoint.

Our group, as everyone before me has

stated, was very involved in our topics of

discussion, very insightful, folks from

different parts of the industry, regarding the

components and what we agree with. The \-- You

know, how can you decide on oversight before

deciding risk, was one of the issues, and we\'ve

heard it before. You know, being the last up,

there\'s gonna be some repetition, and I

apologize for that, but, you know, how can you

decide on oversight before you really

understand what risks you\'re facing and the

degrees of risk and the hazards that those

risks might, might pose?

And then thinking about tolerances

and \-- Once you decide what risk factors there

are, the hazards that they may present, what

are the tolerance levels? And it was felt by

our group that we needed more data, more

information before we could really decide on

that.

And then focusing on significant

risks and, and the significance of those risks.

Again, different parts of the industry,

different processes involved all bear on, on

what levels might be acceptable and, and the

ranking of those, and with all that, you know,

flexibility, and we\'ve heard a lot in previous

discussions. This type of, of a feed safety

system needs to have flexibility. It needs to

be adaptable to the various components within

the, the manufacturing of feed. We, too, like

others, had a real problem with the term

\"contaminant\" or \"contamination.\" The

liability issue, real or perceived, was of

great concern, so our group, as well, was

trying to figure out what we could use as a

synonym to replace \"contaminant.\"

The bottom-up approach was

interesting for us in how you could begin to

develop the risk and the ranking.

Transportation, really interesting

for us. As others had stated: How do you deal

with all of the various modes of transportation

for feed and the different aspects of hazard

and risk that they bring, and then how do you

address those? Let\'s see. Certain farm

(inaudible). Yeah. And then again, different

segments where farms \-- they have different

components. They receive, maybe, ingredients,

or they have complete mix, and so how do those

folks deal with the various issues?

What else, Tim? I\'m stuck.

NANCY: The question was whether

(inaudible) produced feeding (inaudible), and

the question was: The animal (inaudible).

MR. GRANDE: Yeah. Thank you,

Nancy.

NANCY: In this particular

question, there was a discussion about what our

\-- on-farm processes would be controlled. It

said, The farm doesn\'t produce feed; it

produces animals. Question was whether or not

those animals are, are regulatable until they

become food.

MR. GRANDE: Yeah, exactly.

Thank you, Nancy. I appreciate that.

MALE VOICE: (Inaudible.)

MALE VOICE: Animals intended

for food use, such as beef, et cetera, et

cetera, are, by jurisdiction, food, walking

food, so . . . Under FDC Act. All right.

Thank you.

MS. DUNNAVAN: But that\'s \-- But

that\'s why we had our \-- that second \--

MALE VOICE: Second question,

wasn\'t it?

MS. DUNNAVAN: That\'s what led

to that second point here about health for

sale. If you\'re having feed produced on farm

to give to the animals and your real product

are the animals, where is our jurisdiction on

the feed? And that\'s why we have the health

for sale. So we consider that feed health for

sale if it\'s going to, to animals that are

gonna be marketed, so food animals. So those

two, sort of, points kind of go together.

MR. GRANDE: Okay. Thank you,

Glo. You can \-- There you go. Okay. And then

\-- (inaudible). Yeah, and as we\'ve \-- as we\'ve

touched on, recognize that the different

components with \-- within feed need to be

treated differently, because they can \-- they

can contribute \-- There are, potentially,

different risks and levels of hazard, so you

have to treat them differently, and how, how

might that \-- how might that be addressed?

FDA recognizes differences, looking

to incorporate similarities and commonalities,

so, as we\'ve said, you know, how might those

differences be, be addressed? Training SOPs,

control variabilities, you know, what are the

hazards that these types of things might look

to? How do you control different hazards

across the continuum or across the

feed-manufacturing program? You know, how \--

Training, and we heard about training in the

past. How do you train to meet controls that

are set? If there\'s a problem, is it likely \--

(Inaudible) off-the-screen producer. I

don\'t \-- What was that, Nancy? I don\'t know

what that \-- I\'m sorry.

NANCY: I\'ll just hold on to

this for a minute. If there is a problem, the

comment was it was likely to be an

off-the-screen producer. In other words, one

of those folks that you don\'t see very often.

Could be one of those, those portable mixers.

It could be one of those, those folks that\'s

buying something that most of us wouldn\'t think

about. And the comment was \-- to that that the

additional cost of running these programs to

reputable dealers or reputable folks would not

affect the, the bad actor again.

MR. GRANDE: Yeah. What \-- With

this program, how might we be able to

strengthen existing rules, AAFCO, and, and

we\'ve heard about other potential models, other

potential quality system methodologies that

could be used, so how might this umbrella \--

we, we looked at that as a term \-- how might

this umbrella strengthen those?

When we look at ingredients, key

elements, background tests for hazards, what

might those be beyond what is currently

considered industry practice? The \-- Work

upstream from the product, so maybe the, the

table-to-stable, as we heard just a moment ago,

working back might be a way.

Product expectation. You know, the

customer has an expectation for the product

that he or she is receiving, so if the \-- if,

if we look at a product spec, that\'s our

target, and then internal to the operation

would be the processes that you control to

deliver on that product expectation.

Regulatory component to that product absolute

\-- for that product. So specific to the

product that you\'re making, there could very

well be different levels of process control

given on \-- given the product that you\'re

making. It will probably vary based on that

end product and, and the, the spec that you\'re

trying to hit. Processes begin where \-- Yeah.

Where, where might that process begin? Where,

where would the first point be that you would

need to incorporate some type of process

control?

We talked some about the economics

and, and customer expectations. Again, if, if

you\'re trying to figure out what level of risk

avoidance or what types of hazards are

important, it might be looking at the

customer\'s product spec and the expectation

that the customer has, and that could be some

of the framework that you would look to to go

back into your process and develop control

points. Is that \-- Is that a fair

representation? Yeah.

And with that, again, flexibility and

naming hazards. I think this relates to,

again, product-specific or, or process-specific

components within an individual

feed-manufacturing system. And then

specifications. Again, we talked a lot about,

about the, the end \-- the end product, the

finished product, and how the specs that you\'re

trying to hit should dictate what types of the

products \-- what product specs would dictate to

processes within your manufacturing operation.

What exists on the book? What was that, Nancy?

NANCY: That refers again to

what rules, what regulations, what statutes.

MR. GRANDE: Oh. Current,

current rules and regulations, and do we really

need more, given what we already have? And

then maybe marrying those with AAFCO or other

quality-assisted methodologies, could we

strengthen what we currently have and, and

achieve the end result? And then

problem-oriented fixes. Again, trying to be

proactive.

Question 3, missing components.

Traceability. We didn\'t \-- We didn\'t really

see anything about traceability, and that

brought up some real interesting questions

for \-- What exactly is traceability? How, how

far back or how far forward do you go, and then

how do you do it?

Education was a big one \-- and we\'ve

heard that before \-- for training, not only for

folks that might be on the regulatory side,

but, but in the feed-manufacturing facilities,

as well. How do you create awareness for folks

that need to abide by whatever regulatory

issues may present themselves? Point of

origin. What was that, Nancy? I, I don\'t \--

NANCY: That was a question,

again, of keeping track of where your

ingredients \-- where your products came from.

MR. GRANDE: Oh. So the

trace \-- more traceability and tracking within

the program. Record-keeping nightmares.

Again, if \-- depending on how far forward you

might have to go, knowing where your feed is.

I think that was one, one question related to a

particular feed that was sold at the last, last

point of retail. Having to know where that \--

where that feed actually wound up, how would

you do that?

Mandatory system. They have IP

issues. This was intellectual property, so if,

if I have a particular system or process for

manufacturing feed that\'s proprietary and I

have to now share it through inspection or some

other vehicle, I would lose that intellectual

property right, and that was a \-- that was a

concern. And then voluntary self-inspection,

we talked some about how we could \-- how we

could utilize that as a tool to, to create

better compliance.

And then again, our \-- the

components, all part of an umbrella, and again,

we were looking at \-- and thinking about how

this Animal Feed Safety System could be an

umbrella over all of the existing regulatory

pieces and other quality system methodologies

and food safety programs and, and kind of marry

all those, but yet still have flexibility so

that you could address the various

feed-manufacturing components that go into the

finished \-- making the finished product.

Process control, certainly one. I\'m not sure

what the \"who chooses\" \--

NANCY: The \"who chooses\" refers

to: Are you using a process control? Are you

using a product control? And who, who decides?

MR. GRANDE: Yeah. And who

decides, yeah. And I \-- And I \-- Yeah, who

decides. And, and there was a lot of

discussion that we\'re not there yet. We just

don\'t know. More information is needed.

Industry-developed systems are

acceptable. Again, there are several, so

again, under that umbrella, how best do they

fit given where you might be in the \-- in the

feed-manufacturing program? How can we help

you build your system? So I think that was

speaking to this, this whole effort. How could

we \-- How could we build a better feed safety

system? Utilize (inaudible) as part of the

educational team (inaudible) \--

NANCY: That was \"trade

associations,\" for whoever typed that.

MR. GRANDE: There you go. Meet

uniform minimum standard. Yeah, we were

talking about having a baseline, leveling the

playing field for all the folks within the \--

within the feed industry, and then how you\'d

want it to build on top of that is entirely up

to \-- up to you, for, for where you are in the

business.

Without defining standards, how can

you document improvement? Yeah, that\'s, you

know, baseline. We\'ve heard a lot about

baseline. There certainly should be a baseline

coming from FDA, but within an individual

operation, you\'re gonna create your own

baselines. I mean, that\'s \-- Within quality

systems work, you have to start somewhere, so

you, you start building baseline data, and

that\'s from where you measure improvement. So

there could be an argument about having,

actually, a minimum baseline, and then industry

or individual people could build off of that

and, and relate that to their internal baseline

data.

Medicated CGMPs are a shining example

that works, and I think we\'ve \-- we heard that,

again, earlier today, about how that could

be \-- how something similar could be applied

across, across the remaining feed-manufacturing

components.

Transportation, and, and it\'s broken

on the slide, but we, too \-- We had \"mission

impossible\" in quotes, because, as we heard,

earlier, how do you do it with rail and barge

and truck and Ready Mix trucks running around

manufacturing feed? We, we talked a lot about,

particularly with rail and truck, the

diminishing numbers of railcars and trucks,

and, you know, it was \-- Many of us are at the

mercy of the railroads for, for wanting either

dedicated cars or clean cars or knowing that,

that what was in the car previous to your load

doesn\'t present a problem. How do you do all

that? So that\'s why we framed it as \"mission

impossible.\" And then some of the examples,

just the age of equipment and how they\'re

treated out there, verification of clean-out.

There\'s been a big effort on trucks, with,

probably, a pretty good degree of success, but

again, if you go back to rail or barge, it\'s a

much more daunting task.

Backhauls. We talked about the price

of fuel and how folks aren\'t gonna be

deadheading. I mean, they\'re gonna be pull \--

They\'re gonna be want to having (sic) loads

coming back, and you don\'t necessarily know

what they\'re backhauling.

Product disposal. This was \-- This

was the issue with \--

NANCY: It was a damaged load \--

MR. GRANDE: Damaged load.

NANCY: \-- and the trucker,

under DOT regulations, has complete authority

to get rid of that load wherever he wants.

MR. GRANDE: Right. And, and \--

NANCY: It doesn\'t belong to you

anymore.

MR. GRANDE: Right. And, in

fact \-- Yeah. He could sell it, and, and, and

it\'s your stuff, and it could create a problem

somewhere, and so that \-- I think that\'s a,

a \-- We talked about needing to get with DOT

and, and revisit some of those regulations that

were how old? Some \--

NANCY: Well, they were supposed

to write regulations starting in 1990.

MR. GRANDE: Yeah. Yeah. There

you go.

NANCY: Some of you have kids,

you know, that are in the middle of high school

now.

MR. GRANDE: Yeah. Yeah. Yeah.

So, you know, with all that, the regional

differences, as well. We talked about unit

trains and 108 \-- you know, the railcars, and

there\'s more, more folks that are \-- that are

having dedicated railcars, and with that,

there\'s better control, but, you know, if you

have individual cars or smaller, smaller groups

of cars, the control becomes less and less.

Ruminant meat and bonemeal. That was

the situation where you would have to have \--

either owning or leasing cars to know that

you \-- that you aren\'t winding up with some

kind of a cross-contamination issue.

Increased regs can increase risk.

I\'m not sure what that one was.

NANCY: That was a question

regarding: If you put folks at risk for losing

their, their transportation, then they\'ll use

anybody who\'ll haul what they need.

MR. GRANDE: That\'s right.

Yeah. Exactly. Yeah, yeah. And that related

back to the diminishing numbers of folks

hauling stuff.

Approved suppliers, we talked a

little bit about that. How, how do you go

about developing a, a supplier program, an

evaluation program, and then making sure that

what the supplier is delivering to you is what

you\'ve asked for?

On-farm safety issues, again, we

spent some time thinking about, you know, what

\-- what\'s the scope of that, and how do you \--

how do you level that playing field with \--

against some of the commercial feed

manufacturers? And that\'s been discussed, I

think, enough.

Feeding food, producing animals,

customer satisfac \-- Yeah, again \--

NANCY: Customer \-- Yeah, the

customer satisfaction issue there is: Can you

sign that certificate that says that cow hasn\'t

eaten any ruminant material? Can you \-- Can

you make sure that you\'re part of that Pork

Quality group?

MR. GRANDE: Right. Do you

really know? Yeah. Do you really know? Yeah.

Again, education. Very broad topic,

starting with the consumer and going back or

starting with, with folks in the \-- in the

feed-manufacturing program and going forward.

It really doesn\'t matter. Just everyone needs

to understand what \-- you know, what the feed

safety program is all about and where they play

and what their contribution needs to be.

I.D. the risks, spot \'em up. That

was \-- Yeah.

Finding and inspecting ruminant

feeders. What is the risk and perceived risk?

What was the emphasis on that, Nancy? I \--

NANCY: Well, the emphasis there

was particularly regarding the next statement

that says, Some risks, such as that for BSE,

are decreasing because of increased compliance

with the rules and the changes to the rules,

but, as we heard earlier today, the perception

of that risk is still very, very high.

MR. GRANDE: Right. Yeah. And

then: What is the risk of unapproved

ingredients? We heard \-- We heard some of

those comments, the \-- today. It\'s an unknown.

What is the risk?

State regulatory programs are more

effective. The funding issue, we\'ve heard.

You know, as the scope grows and with budgetary

constraints, you know, how do you do more with

less?

Reinforce issue and compliance with

AAFCO definitions. Again, the umbrella issue,

looking at current programs out there married

with quality systems methodology, and define

risks and hazards, focus on bad actors, so if,

if you\'ve got folks that are doing what needs

to be done, doing a good job, can you turn your

attention to, to areas that, that might be more

important in risk and hazard control?

Voluntary process control. I think

that relates to the inspection \-- the

self-inspection program. Having capable and

trained personnel. So again, how do you

effectively train and make sure that your folks

understand their roles and responsibilities?

What other \-- What other issues might

AFSS help us with? Well, getting

industry-involved, and that\'s certainly evident

today \-- over the last two days, and then

having representatives of those folks as part

of the \-- part of the development of this \-- of

this program.

And I think that\'s it. Sorry for it

being so disjointed.

MALE VOICE: We have a couple

over here.

FEMALE VOICE: I\'m so sorry,

everybody. I was part of this group, and I

just wanted to comment. We did have quite a

bit of discussion about \-- The, the Food and

Drug Administration is sort of talking here

about risk and hazards and \-- but our group did

have a \-- just a lot of discussion about the

fact that there are other things to think about

when you\'re \-- when you\'re looking at these

systems and customer satisfaction, and, and

being able to talk about your quality product

to your customers is a real advantage and a \--

something that our group talked about, even

though FDA is kind of focused on, on the risk

and the bad stuff. So I think that was an

important point that we spent quite a bit of

time on.

MR. WILSON: Do we have any

other questions of this group? Ladies and

gentlemen, I want to thank you very much.

MR. HERMAN: Yeah, I\'d like to

make a comment.

MR. WILSON: This has been a \--

Whoa. Never mind.

MR. HERMAN: Yeah. Yeah. Tim

Herman, Office of the State Chemist. That is

Texas State Chemist.

MR. WILSON: Republic of?

MR. HERMAN: If, if there was

only \-- No. You\'re gonna have a little bit of

fun with that.

I think that maybe \-- And we have one

other folk \-- person from Wyoming, who was

there, who could answer No. 7, and I think

Question 7, what make \-- what state regulatory

programs \-- or excuse me \-- make state

regulatory programs more effective, and I think

maybe we were the only ones who had that

question, so I just wanted to reinforce on

those components that, certainly, when I look

at it, Component 1 and 2, felt real good about;

Component 4, I think we all agree, you know,

show us the money; and Component 3, I don\'t

believe that there was an entire consensus, but

perhaps voluntary is the way to go, the way

everybody believed that process control would

be part of this overall universal concept of

what should be part of an animal feed safety

system, but how that would actually fit within

a regulatory scheme and \-- or at a state level

was something that \-- Well, maybe the emphasis

should be on voluntary, but clearly,

Component 1 and 2, we thought you guys were

really right on track and wanted to give you a

kudos in terms of how that can help us at a

state level.

MR. WILSON: Once again, any

more questions, please? Okay. Going once.

Again, ladies and gentlemen, thank

you for the \-- for your open-discussion stuff

on these \-- on these last, you know, very

important \-- we\'ve \-- we, as FDA, feel are very

important issues. And we\'re not concluded yet,

because at this point, now, Ms. Gloria

Dunnavan, our \--

MS. DUNNAVAN: Really open

discussion.

MR. WILSON: \-- is going to have

a truly open discussion, which I\'m sure she has

plenty of material to lead into to stimulate

the open discussion. Glo, take it away.

OPEN DISCUSSION MODERATED

BY GLORIA DUNNAVAN

MS. DUNNAVAN: Well, no, I\'m \--

This is just your one last wonderful

opportunity \-- and I\'m gonna go up front and

sit down \-- to, to, to ask and get answers to

questions, to comment on issues that did not

come up in our discussion today that you would

like to comment on. We\'ve got about a half an

hour, and I\'d like to just open it up to, to

that kind of discussion, just give you a last

chance to, to comment, to question. You got a

captive audience here. The Animal Feed Safety

System Team is all present. It\'s a good

opportunity to \-- I\'m not gonna get any takers,

am I?

One of the things I want to comment

on \-- and maybe, maybe you can address that a

little bit \-- in listening today, there were

some common themes that I picked up on:

science-based, need more clarification;

transportation, who\'s really covered; need

cost-effective tests; imported products and

the, the complexities of dealing with that; and

education. And those were just some things

that I heard in multiple presentations, and I

don\'t know if I missed \-- if there\'s some

others that you think are, are common themes

that we really need to think about and focus on

some more. Let me hear from you. Have any

comments? Yes?

MR. BURKHOLDER: Dave Burkholder

from here in Nebraska. There is some

uneasiness out here among the group, I have

kind of detected and felt myself, that FDA and

this whole risk-assessment process is, is going

to, to have the resources to, to draw up some

scary-looking material and, and put it in \--

out in the public domain for, for the enemies

of animal agriculture to, to jump on without

really having the resources to implement the

program anyway, and therefore, you know,

nothing really constructive is gonna get done,

and a lot of not-constructive stuff is likely

to happen. Would you address that, please?

MS. DUNNAVAN: Well, I\'ll be

happy to address that. I\'ll first see if

there\'s any members of the team that want to

address that. I, I just, from my \-- Oh, okay.

Go ahead, Karen.

DR. EKELMAN: Well, Glo, I was

gonna wait \'til you were done. I was just

going to say that if you do have a risk-based

approach, first, remember that we\'re not

estimating absolute risk, so you won\'t be able

to say, You ought to take care of this one,

because even though it\'s eighth down on your

list, it\'s 1 times 10 to the -9th animal is

going to die from this. You won\'t get that

information.

Secondly, if you have a risk-based

program, no matter what the resources are you

have to devote to it, you at least can know

that you\'re dealing with your most significant

risk, so if you have a lot of resources, you

can go further down that list. If you have

fewer resources, you don\'t get so far down that

list. But one thing you can do is use that

list to ask for more resources and ensure that

they\'re going to be used in a

risk-based-appropriate manner.

So it isn\'t really expected that

we\'re gonna have a lot more resources. It\'s

expected that we\'re gonna focus those resources

a little differently, and I\'ll let Glo \-- Since

we don\'t have an animal safety system yet, we

often have different points of view, and we\'re

working on it. Thank you.

MS. DUNNAVAN: Karen and I

particularly have, sometimes, different points

of, of view.

Let me just make two comments. One

of the things that I \-- that I certainly heard

in my group, and I think I\'m sort of hearing

today, and I think this is, in part, your

comment, is that FDA is gonna come up with this

complicated, scary, new thing that, you know,

you\'re gonna have to scrap everything you\'re

doing now, and it\'ll be this new thing, and I

really don\'t think that\'s our intent. There\'s

a lot of good stuff out there going on, and I

suspect, for many of you in this room, if

you\'re an industry representative, that the

concepts we\'re talking about here, you may

already be doing a lot of that, and it may just

be focusing it in a particular way or tweaking

it or making \-- helping to make sure that some

of your suppliers and customers are part of the

loop. So I\'m not sure that \-- for many of you,

that it\'s a brand-new, scary, different thing.

It\'s a more focused approach to a lot of what\'s

already going on.

I, I \-- In my personal view, the

train is moving out of this station. Instead

of focusing on doing stuff, making a product,

and then at the end, you sort of look and make

sure, Do I \-- Is my product okay, and if it\'s

not, you\'re missing \-- you\'ve just thrown away

a huge bunch of work and effort, so that the

sort of trend, as I see it, is to make sure

that you have processes in place so you don\'t

have to get to the end and test your product

and throw it away, but you can fix the problem

early, or you have assurances in place, you

know you don\'t have a problem at the end. So,

I mean, that\'s one issue.

The other one is that \-- the issue

you bring up about resources. As the Director

of Compliance, you know, I\'m kind of the

enforcer here, and one of the things in my

position is, is the emergency coordinator for,

for CVM. I can\'t tell you just how many

resources we end up spending when there is one

of these emergency situations, one of these

animals dying or feed contaminated, and we need

to get control of it. You spend an awful lot

of resources, and the states spend a lot of

their regulatory resources in ways that we

can\'t plan \'cause it happens today. You got to

deal with it today. And that takes many more

resources to deal with that kind of situation

than if we could have a program where we plan

inspections, we plan some sampling, we plan our

outreach efforts. And we can \-- We can plan

that during the year so that we can use our

resources most effectively.

So one of the \-- One of the problems

I see \-- and I don\'t know if, if my state

counterparts want to comment on that \-- I think

having a good program in place, that sort of

covers the waterfront, makes it much easier, as

an \-- as a regulatory agency, to plan and deal

with these issues rather than, than being in

crisis mode all the time, and you got to deal

with Situation X, and then some of these other

things don\'t get done, and at the end of the

year, you\'re suddenly forced to sort of

scramble and get something else done, and

you\'re always in catch-up mode.

So I think this will be helpful from

a resource \-- actually, helpful from a resource

perspective when resources are not likely to,

to be increasing in the near future. Probably

not in the distant future either.

Dennis?

DR. McCURDY: Dennis McCurdy,

CVM. In response to what you\'re talking about,

there was a paper \-- it\'s on the Web, and it

was forwarded to CVM \-- that appeared in

Journal of Animal Science. The paper misses a

lot of things, and I\'m responding to that

officially for CVM. There was a meeting held

at Fort Detrick in Frederick, Maryland, about

that paper, and the authors were at Fort

Detrick and principally focused on biosecurity

and, and things that can happen in feed, but

the thrust of the article was \-- is, we\'re not

doing enough to protect the consumer. That\'s a

large order and \-- of accusations in that \-- in

that \-- accusation in that paper, and I am

responding to it, because it\'s not \-- it\'s not

true in the complete sense. But there are

scientists and people who think they can get

some government money by selling the

proposition that we aren\'t doing enough,

so . . . Is perception everything?

MALE VOICE: This isn\'t on that

subject, but a year and a half ago, when we

were in Virginia and had this meeting, we

counted in \-- There was only 10 percent of the

people from west of the Mississippi, and I

counted \'em up again today, and I realized we

don\'t have as many people here as we had back

in Virginia when we had that meeting, but close

to 45 percent of the people are from west of

the Mississippi today, so I think you got a lot

broader spectrum by meet \-- bringing your

meeting out here \-- out of the industry, and

really appreciate your willingness to come out

here to work with us, so . . . Thank you.

MS. DUNNAVAN: Thank you very

much for that. That\'s very insightful for us,

and if you walk away with nothing else from

this meeting, one of the things that I want you

to walk away with is, all of the comments that

we\'ve heard today and in the discussions

yesterday are extremely valuable for us.

That\'s why we have these meetings. We, we need

the input. There were some \-- I mean, it\'s,

it\'s very interesting to me to sit around \-- We

talk about this, and we work on this, and we

think about it, and it\'s just crystal clear,

the vision, where we\'re going and what we\'re

gonna being doing and why we\'re doing it, and

it\'s very clear to me today. It\'s \-- The

vision is clear to me, but it\'s not so clear to

all of you, and it\'s really, really important

for us to hear that, so I \-- I\'m \-- I

particularly appreciate the fact that we\'ve got

different types of, of representatives here

from different parts of the country than we\'ve

had before and perhaps haven\'t had a lot of

discussion before about this, and so it\'s new

for them, and we get new and different eyes

looking at this and commenting on it. It\'s

extremely helpful for us.

So again, this is \-- this is a great

opportunity for you if you have something you\'d

like to say, a question, a comment, something

you want us to consider.

MALE VOICE: One of the things

that I find missing, which my company is

dealing with, and that is, you know, we hear of

a few animals here dying or a few animals there

dying, and we look overseas, and even in our

own country now, where we have these millions

of animals being destroyed because of a major

disease outbreak, and it seems like, to me, it

would be very proactive and would actually

complement what we\'re doing here if we started

understanding what role we would play or not

play in feeds as far as a major outbreak, what

we could do to mitigate, what we \-- where are

our risks, that we could actually either break

an animal disease outbreak, make sure that it

didn\'t get transmitted through feeds, or, or

whatever, or where our risks really are in that

whole incident, if and when it may occur.

MS. DUNNAVAN: Actually, that\'s

a really good comment and one that I, I

didn\'t \-- I didn\'t comment that I\'d heard it,

but I\'ve heard that from a couple of groups,

that role of, of animal disease and animal feed

related to animal disease and where we fit in,

and that\'s certainly, certainly a risk, and I\'m

not sure we\'ve had a lot of talk about that. I

know the risk group is sort of focused more on

the, sort of, known pathogens and the

chemical-contaminant-type things. So I think

that\'s a very valuable comment that we need to

go back and talk about, and, and I guess the

risk group \-- the group \-- the subgroup that\'s

working on that is hearing that and, I know,

will be taking that back to talk about and try

to factor in.

MR. LATNENBURG (phonetic):

Yeah, my name is Matt Latnenbrog \-- burg

(phonetic), by the way, and yes, I\'ll identify

myself. I\'m with APC, Incorporated. But \--

MS. DUNNAVAN: Thank you.

MR. LATNENBURG: \-- basically,

we are looking into, well, many incidences,

such as what in \-- as specific disease, is a

thermal destructive force, and what would USDA

or FDA accept to get us back into operations,

for an example, and \-- you know, so we don\'t

have to wait until this crisis occurs to start

understanding, as a feed group, what feeds are

in danger, what can we do in our feed

operations to render the product safe, where a

government agency would allow us to again start

productions and the like, and I think these are

things that certainly I\'m working with some

universities at present, and we\'re just seeing

how much traction we can get to, to support

such an activity.

MS. DUNNAVAN: Do we have any

other comments? questions? concerns? issues?

MR. ROACH: Yeah. Hello. I\'m

Steve Roach with Food Animal Concerns Trust.

We\'re a consumer group. I just wanted a little

clarification on part of the program, \'cause

there seemed to be two things, and I just

wanted to get this clear in my mind. I wasn\'t

clear. So you \-- You\'re doing two \-- several

different things. You would be doing risk

assessments to define which things you see as

the highest risk, and that\'s one type of

assessment, but then related to that is setting

the contaminant levels. So that\'s

semiqualitative, but then when you would set a

contaminant level, that would need to be

quantitative, and those would be two separate

processes, or maybe one would come after the

other? I\'m just \-- Because there are two sort

of similar things: setting the risk of

something, and then another thing is to set the

contamination. And is that correct, my

understanding?

MS. DUNNAVAN: I think you\'re

right, and I\'m hoping that the, the risk group

will comment for me some more on that.

DR. EKELMAN: I think you both

have it \--

MS. DUNNAVAN: Thank you, Karen.

DR. EKELMAN: \-- exactly

correct. We\'re using a relative risk-ranking

method for our risk ranking, and we will use

that to, to inform us about whether or not we

need to develop limits for contaminants \-- I\'m

going to use that word now, I understand

everybody wants me to think of a different word

\-- or the government to think of a different

one \-- and then we will use a very

quantitative, our usual analytic method,

reviewing data, coming up with what we consider

to be a safe level, considering background

contamination rates and things like that.

So you\'re right, the first is

semiquantitative, and the second one is a very

quantitative effort that we have done for

things like fumonisin.

DR. GRABER: I might add, the

risk-ranking procedure, the method, is

something we are doing as \-- under the Animal

Feed Safety System Team, but any work, probably

coming out of additional limits for additional

adulterants, contaminants, whatever the right

word is, is work that we\'re gonna do as we

do \-- as we\'ve done for any other contaminant.

That \-- There\'s processes \-- There\'s groups

that are established to do that work, and there

are processes in place to do that work.

So that\'s \-- You know, if tomorrow,

Compound X needed to be \-- we, we decided we

were gonna go out and establish some sort of

limit for, say, dioxins, we would be \-- we

would have \-- we have processes in place to do

that, and we would do that using the people

and, and organization that we\'ve had for many

years.

MALE VOICE: Just to follow that

right up, in other words, we can get rid of

Delaney (phonetic) because you\'re going to have

established what the real risks are, so we

don\'t need that?

DR. GRABER: Delaney and I are

not on speaking terms.

MS. DUNNAVAN: Okay. Do we

still have some burning issues we want to bring

up? This is one last chance. If we don\'t have

any more comments or questions, I do want to

just comment that Toni Wooten, Regulatory

Information Specialist in my division, is

responsible for the hotel and the amenities

that we\'ve had at the hotel, and as usual, she

has done an excellent job, and our Animal Feed

Safety System Team did a lot of work in \--

behind-the-scenes work in, in getting ready for

this meeting and having it run smoothly, and I

want to thank them all.

CLOSING REMARKS

BY GEORGE GRABER, Ph.D.

DR. GRABER: Okay. We\'re down

to the end. I just got a few remarks that I\'d

like to make, and first of all, I really want

to thank everyone for coming to this meeting,

them taking the time from your (sic) really

busy schedules to be with us. I don\'t really

want to name any people, but I probably will

thank some people for being here, especially

the, the states and the FDA personnel, district

personnel, for taking time out to be here and

to participate.

Again, the industry, we \-- I don\'t

know. Sometimes we take it for granted that

they\'ll be there, and we look down at the

attendance at this meeting, we had, at least in

terms of yesterday \-- As of yesterday morning,

we had 203 people registered for the meeting

and that actually showed, so that\'s \-- that was

very good, and I think we ended up having \-- Of

the people who originally said they\'d be here,

I think there were, like, maybe 10 to 12 people

who couldn\'t make it for whatever reason. So

we\'re really, really pleased with the turnout.

I want to thank the reporters for

volunteering to, to come up here in front of

the group and report the work of the breakout

groups, and, and Glo has already thanked the

members of the Animal Feed Safety Team.

Probably be remiss if I didn\'t thank

(inaudible) for all the work she\'s done behind

the scenes for, for making sure this, this

program went off smoothly and all the others,

so I\'m sorry if I don\'t mention anyone\'s name.

There are the comments \-- The comment

cards are still \-- if you still have a comment

card, if you had some comment that you didn\'t

feel appropriate to make in the group and still

want us to know about it, please fill out the

comment cards and put \'em in the box in the

back. Same thing \-- We\'d like for you to fill

out the evaluation form, as well, and put that

in the box before you leave today.

We will be \-- As \-- We\'re

transcribing yesterday\'s session and today\'s \--

yesterday morning\'s session and today\'s

session, and that information should go to the

docket fairly soon, and \-- probably a month or

so, but we\'re gonna try to put things up on the

CVM Website sooner than that, so \-- The

PowerPoint presentations from yesterday and the

Word reports that you saw up here today will go

up on the CVM Website, maybe in a week or so,

so look, look, look for them.

One thing I did \-- You know, I wrote

my down \-- wrote myself some notes here, and,

of course, I forgot to mention something when I

was thanking people. I \-- One of the

individuals just mentioned something about the

fact that we had a lot more people west of the

Mississippi come to the meeting we were out

here \-- by meeting out here as opposed to

Virginia, and there is a comment in the docket

already arguing that the reason that we \-- the

reason we\'re out here is because we\'re in bed

with the \-- with the industry, and we should

have had it back in Washington because then we

can get all the trade associations. So, you

know, you can\'t win from losing, so . . .

But I really do appreciate the fact

that we do have some producers and producer

organizations here. It was something \-- We had

a few at the meeting, but having actual

producers show up at this meeting was, was

extremely gratifying and, and very helpful for,

for the \-- for the group to hear.

The \-- In breaking \-- In putting \--

assigning people to the breakout groups, the

idea was to try to get a cross-section of

people within each breakout group, and somebody

mentioned something about the fact that some

groups didn\'t have any producer groups in \'em,

and they should have. There were some producer

groups that didn\'t, didn\'t show, and we

probably didn\'t move them \-- some things around

at the last minute and try to make sure we had

producer groups and \-- producer groups

represented in all the breakout groups. So

hopefully, next time we have a meeting, if

there is a next time, that we\'ll have more

producer groups in attendance so we can ensure

that their voice is heard with all the breakout

groups.

Next steps. Well, obviously, there

was a lot of information presented here, and

the Animal Feed Safety System Team will review,

digest, discuss. We\'ll have the \-- what was

Charles Breen\'s comments? \-- the full, frank

and vigorous discussion about some of these

issues, and, and I\'ll tell you that we do have

such discussions.

And so one thing we\'ll do, obviously,

is, is make some decisions about what our \--

what we consider to be the next steps for this

particular group. We\'re gonna decide \-- or at

least develop the options that we\'ll present to

the senior management team within the Center of

Veterinary Medicine as to what products we\'re

gonna work on and then get their blessing on

that, and that\'ll, hopefully, get us to the

year 2007 or sooner.

There are some items that will come

out of this group, and I\'ve mentioned already,

that probably will not be necessary for the

Animal Feed Safety Team to work on, but there

are some good ideas here that perhaps the

Center for Veterinary Medicine could be the

Office of Surveillance and Compliance. It

could be the Office of Research within CVM, or

it could be the Office of Regulatory Affairs.

Some, some good ideas have come out of this

meeting that won\'t fall exactly under the, the

premise of the Animal Feed Safety System.

That, perhaps, people should be working on.

They could be compliance policy guides. They

could be revisions to programs. They could be

additional educational efforts. But we\'re

gonna try to capture all that information and

ensure that it gets full deliberation.

So with that, unless anybody has any

further comments, I want to wish you all a safe

trip, and \-- no matter where your travels take

you, and thank you for participating in this

very important meeting. Thank you.