UNITED STATES DEPARTMENT OF AGRICULTURE

WASHINGTON, D.C.

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ADVISORY COMMITTEE ON :

BIOTECHNOLOGY AND 21ST CENTURY :

AGRICULTURE (AC21) :

NINETEENTH PLENARY MEETING :

:

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A meeting in the above-entitled matter was held on Wednesday, May 28,
2008, commencing at 8:35 a.m., at the USDA, 1800 M Street, N.W., ERS
Waugh Auditorium, Washington, D.C. before:

Michael Schechtman, Ph.D., Designated Federal Official

Patricia Layton, Chairperson

[A P P E A R A N C E S]{.underline}

Abby Dilley, RESOLVE

Cynthia Sulton, HW&W

Kathy Grant, RESOLVE

[MEMBERS OF The AC21 PLENARY COMMITTEE]{.underline}

Patricia Layton, Chairperson

Stephanie Whelan

Carol Tucker-Foreman

Margaret Mellon

Alison VanEenennaam

Bradley Shurdut

Jerome Slocum

Guy Cardineau

Leon Corzine

Greg Jaffe

James Robl

Adrian Polansky

Daryl Buss

Larisa Rudenko

Steven Leath

Steven Hensley

Jamie Jonker

Marcia Holden

Michael Engler

Fuller Bazer

Nancy Bryson

Elizabeth Milewski

Russell Kremer, Absent

[A P P E A R A N C E S]{.underline}

[Page]{.underline}

Nancy Bryson 41

Craig Morris, AMS 93

Barbara Glen, BIO 194

[P R O C E E D I N G S]{.underline}

DR. SCHECHTMAN: Welcome and good morning. I hope everyone had an
enjoyable Memorial Day holiday. This is the nineteenth meeting of the
U.S. Department of Agriculture\'s Advisory Committee on Biotechnology
and 21st Century Agriculture or AC21. My name is Michael Schechtman and
I\'m the Executive Secretary and Designated Federal Official for the
AC21.

Welcome everyone. To my left is the AC21 Chair, Dr. Patricia Layton,
who\'s also Chair of the Department of Forestry and Natural Resources at
Clemson University. She will be providing remarks in a few minutes. To
my left and right are our facilitators, Ms. Abby Dilley and Ms. Kathy
Grant from the organization RESOLVE and Ms. Cynthia Sulton from the
organization HW&W who are our partners in helping us make this advisory
committee process work.

We have around the table members of this advisory committee and *ex
officio* members representing several other federal agencies and the
State Departments of Agriculture and several other members and ex
officio members will be joining us as well during the course of this
meeting. I note that at least three people have sent messages saying
they were having trouble getting either into town or around town this
morning so those people will be coming in a bit late.

I have the pleasure to note that we will have a new *ex officio* member
from the Food & Drug Administration here today. She said she was running
a little bit late. She is Dr. Larisa Rudenko who is Senior Advisor for
Biotechnology in FDA\'s Center for Veterinary Medicine. We\'ll give a
premature welcome right now and say hello when she arrives.

Let me remind the committee that just as for USDA officials it would be
an unproductive use of committee time to put Larisa on the spot for FDA
to discuss regulatory policies around transgenic animals that have not
yet been released publicly or are still under discussion and development
and obviously that she can\'t talk about. If she can\'t talk about them
she\'s not going to be able to \-- we can figure more productive ways of
using our time.

Additionally, let me mention that another of our *ex officio* members,
Paul Saxton from the Department of State, has moved on to another
assignment in biotechnology in the State Department. We wish him well.
We do not at this point have another replacement from the State
Department however.

We will have some additional USDA business at this meeting as well. We
will have two USDA speakers at this meeting, one today and one tomorrow,
providing additional information to the committee to help you in your
work. I will introduce those members, those USDA speakers later on. In
addition, one of our committee members, Nancy Bryson, will give the
committee an earnestly wished for presentation later this morning on
USDA legal authorities relative to transgenic animals.

We will, as usual, have a very full agenda so we ask that when the
meeting is in session conversations need to be limited to those between
members.

The public will be invited to participate by providing comments to the
committee and USDA this afternoon between 3:30 and 4:45 p.m. For members
of the public who request to speak during the public comment period, I
will need hard or preferably electronic copies of your remarks. We will
be preparing the minutes of this meeting and a computer transcript of
the meeting will also be available within six to eight weeks. We hope to
get the minutes and all meeting announcements up on the Web as per
usual.

The AC21 has a web site link to the overall USDA website. It can be
reached through USDA\'s main portal at www.usda.gov by clicking on
agriculture, then biotechnology, then on the committee\'s name. For any
members of the press who may be in attendance you\'re welcome to speak
to whomever you wish during the breaks of this meeting and before or
after the meeting itself. We ask that you not conduct any interviews or
request comments from members while the AC21 is actually in session.

I and the AC21 Chair will be available for questions and comments at the
end of each day of the meeting. As Pat did a moment ago, I\'d like to
request that all members of the committee as well as all members of the
audience and the press, should any be here, please shut off cell phones,
beepers, and Blackberries while in the room. They interfere with the
transcript.

Bathrooms are located just outside the restricted access door through
which you were let in and straight across the hall. For the information
of the members of the public, let me indicate that the AC21 has two
distinct general charges from the Secretary of Agriculture in its
charter.

The first is examining the long-term impact of biotechnology on
agriculture and the work of USDA which the AC21 has interpreted to mean
over the next five to ten years and, secondly, addressing pressing,
specific biotechnology-related issues again defined by the Secretary.

The committee has already completed four significant pieces of work
related to these charges and the those four AC21 consensus reports are
available for the public on the table at the back.

Over the next two days we have only one main objective for the committee
and that is to continue the committee\'s consideration of potential USDA
regulatory and marketing roles in the oversight of transgenic food
animals intended for food or non-food uses. To add some additional
clarity, the committee last time opted to extend its oversight beyond
what is strictly within USDA\'s purview by looking at the question from
the standpoint of the whole U.S. Government without diving into the
details of potentially overlapping regulatory authorities, but perhaps
including consideration of overall USDA competencies as well.

Now, as I indicated, just to the right of the door there\'s a table with
meeting documents and background documents on them. Please take only one
copy. For this meeting we have a fairly large, long series of documents.
There are a number of more general background documents which include
the official Committee charter, which I think we\'re short on copies of
this morning, but undoubtedly, all Members have it and we can make more
copies if any members of the public want; the AC21 Bylaws and Operating
Procedures; a package of biographical sketches of all the current AC21
members; and the draft meeting summary prepared from the eighteenth AC21
meeting held on March 5th and 6th, 2008 and two draft work group
conference call summaries from calls made on May 2nd and May 19th of
this year.

Finally, we also have as background for the public the earlier four
reports that were developed by consensus in 2005, 2006, and 2007 on the
table. More specifically, for this meeting we have a number of
informational documents. First, the provisional agenda for this meeting.

Second, the outline for a possible paper developed by facilitators and
me based on the conversations held during the two work group calls and
the discussions as the last plenary. We\'d like you to consider whether
the outline that\'s provided will meet the committee\'s needs as the
basis for going forward.

There are brief excerpts from a summary from a series of workshops held
in 2005 by the former Pew Initiative on Food and Biotechnology relating
to attributes and components of an ideal regulatory system for
transgenic animals.

Fourth. The background documents prepared by the committee\'s own Nancy
Bryson outlining the range of USDA regulatory authorities that are
potentially relevant to USDA oversight of transgenic animals. Nancy will
discuss and expand upon that document in her presentation later this
morning. Although she\'s not here yet, I\'m sure everyone will join me
in thanking Nancy for all her efforts. We\'ll do that again when she
arrives.

Fifth. A background document describing USDA oversight on imported
animals and products derived from it.

Sixth. A background document package describing activities of USDA\'s
Animal and Plant Health Inspection Service, APHIS, under the Animal
Welfare Act, including certain activities specifically relevant to
genetically engineered animals.

Seventh. A background document describing the activities of USDA\'s
Agricultural Marketing Service, AMS, having to do with voluntary
marketing claims made with respect to animals or products.

Eighth. A background document package describing aspects of working of
USDA APHIS\' National Animal Identification Program, and

Ninth, a copy of an email I sent to the committee briefly describing
information gathered on the workings of European Commission\'s Advisory
Body on Ethics. Five of these documents were items that members of the
committee specifically identified at the last meeting as potentially
useful background information. And in addition to these documents, the
committee and the public will hear specific presentations as well
related to, again, two of those topics today and one of them tomorrow.

Please note on the agenda that there are breaks scheduled in the morning
and the afternoon. For members of the public who wish coffee, coffee is
available at a restaurant just outside the building on the ground level.
Also on the agenda let me note that we are again planning for a period
of one and a quarter hours for public comment from 3:30 to 4:45 p.m.
today. We want to be responsive to the needs of the public and we\'ll
see as the meeting progresses how we need to structure that time. If we
have spare time in that period we will find other uses for that time as
always. As it always is, we\'re very busy.

Members of the public, if you wish to make a comment and you\'ve not
done so already, please be sure that you\'ve signed up at the door so
that we can plan for this time. I\'ll save my other remarks about the
upcoming work on transgenic animals for a little bit later and let me
instead turn to our Committee Chair, Dr. Pat Layton, for her words of
welcome and thoughts.

DR. LAYTON: Good morning. I hope everyone had a pleasant journey here,
whether you came locally or from far away. In the South, we\'re still in
extreme drought, or least my part of the South. I think that we have a
productive schedule for the next two days of meetings, today and
tomorrow in meetings. I hope that we are able to accomplish as much as
possible and to enter into these discussions in a manner in which we can
produce a document by the end of our time period.

I think it\'s an interesting subject with many viewpoints and if we
share those viewpoints in a collaborative manner I believe that we will
come out with the best document possible. I welcome you all and because
there\'s so much on the agenda I\'m going to move right along into our
first item which is for Cindy and Abby to give an overview of the agenda
and a prior meeting summary and I believe we will have Cindy first with
our meeting summary. So, Cindy, if you would give a meeting summary.

MS. SULTON: It\'s my pleasure to give you the summary of the last
plenary session of the AC21 and invite your corrections and additions to
this record. The last meeting was held March 5th and 6th of 2008 in
Washington. We did a lot at that meeting.

We welcomed new members and thanked departing members who were present
because we also made a presentation at that meeting of our paper, a
consensus paper on, "What issues should USDA consider regarding the
coexistence among diverse agricultural systems in a dynamic, evolving,
and complex marketplace?"

That paper was received by the Chief of Staff from the Secretary\'s
Office, Mr. Dale Moore, who noted the timeliness of the topic and that
the issue was being raised in the Farm Bill debate and specifically in
terms of the Department\'s efforts to maintain a level playing field in
supporting the different systems of agricultural production.

After that, Dr. Schechtman welcomed Under Secretary for Marketing and
Regulatory Programs Bruce Knight who provided an update on FDA animal
cloning risk assessment and USDA transition activities, speaking about
the voluntary moratoriums by the technology providers as per the request
of USDA and also about the Supply Chain Management System that was
provided and has developed.

Under Secretary Knight introduced Michael Gregoire who was the new
Deputy Administrator for the Biotechnology Regulatory Services within
APHIS who then provided an update on what APHIS is doing to update the
GE regulations. He also provided the committee with an update on the
activities relative to the Biotechnology Quality Management System,
BQMS.

And, finally, he reported on back, Corn Event 32. We then turned to the
new charge on transgenic animals which was introduced by Dr. Schechtman.
This is followed by discussion among members of the committee. We agreed
on parameters critical to shaping their work plan for the new charge and
among those completing the work within two full committee \-- to the
three full committee meetings and working at the same time as the
government across multiple agencies would be discussing the regulation
of transgenic animals and recognizing that also there were animals,
transgenic animals in foods that were presently being developed for
commercialization.

The committee members also identified basic principles to be included in
a regulatory road map. Among them, benefit analyses, food safety
determination, the animal health and welfare environmental impact
evaluation, public participation, and transparency and clarity of the
road map.

Obviously the discussion was much richer than that. Those are some of
the highlights. In anticipation of further deliberations the AC21
members discussed additional information and then agreed on a work plan
for continuing its work. We did have at the last meeting four members of
the public who provided comments to the committee, two on the
coexistence paper, Matthew Rales of Westin Price Foundation, Joe Salatin
of Palisades Farm and representing the National Independent Consumers
and Farmers Association. Jaydee Hanson from the Center for Food Safety
commented on FDA\'s risk assessment on cloned animals and safety
concerns with cloning transgenic animals. Nina Mak of the American
Antivivisection Society commented on USDA\'s approach to cloned foods
citing reports from the European Food Safety Authority and the European
Group of Ethics.

We then concluded by reviewing our work plan and agreed to convene a
work group to further explain the committee\'s charge as it relates to
transgenic animals and to provide information on three topics at the
next meeting and then talked about scheduling our next meeting.

The meeting was concluded with comments from Dr. Schechtman. Are there
any corrections, additions, modifications to the minutes? If there\'s
none right now I would ask the members of the committee to kindly
provide any that might come to mind within the next ten days so that we
can post this summary on the Web. Thank you.

DR. LAYTON: Abby.

MS. DILLEY: Only for those of you who came in during the introductions,
et cetera, I thought we need to do that for a mike check but also for
you to do a brief introduction to the committee. Jim, I know you came in
and I don\'t know if anybody else did.

DR. ROBL: Jim Robl from Hematech.

DR. LAYTON: Mardi.

DR. MELLON: Margaret Mellon from the Union of Concerned Scientists.

DR. RUDENKO: I\'m Larisa Rudenko from the Center for Veterinary Medicine
at FDA.

DR. SCHECHTMAN: Welcome, Larisa. We welcomed you in your absence.

(Discussion off the record)

MS. DILLEY: I was just going over briefly over the agenda. We have a
green agenda in the back of the room. It\'s for committee members. It\'s
the same agenda you received from Michael which was slightly revised
from the previous one as part of the presentations.

Just a couple of notes on the agenda. As Cindy already reviewed and
Michael\'s already gone through in terms of a variety of different
materials that you have and a reminder of the last meeting in March we
did have a work group convened twice by conference call, the result of
which we\'ll talk about in a little bit more detail a little bit this
morning.

It\'s a draft outline that was developed through the course of their
discussions that further built on the discussions that we had in March
about the scope of what we wanted to do and how to frame our
deliberations given several contextual considerations including the fact
that the discussion of transgenic animals is underway within the
government and those are active and don\'t have anything public at this
point. So, try not to second guess those discussions, but try and do
something that is recognizing that that\'s going on at the same time the
committee is trying to get their arms around a couple of things to
respond to the charge given to the committee.

And then I can provide the information. I think one of the major things
that we\'re trying to wrestle with, and it came through in the
discussion in March as well as the small group discussions, are trying
to do the big scan as we talked about in March, about what are some of
the considerations in thinking about federal oversight or government and
transgenic animals that are being developed both in the U.S. and abroad
and then also recognizing that we\'re not going to get into the weeds of
that debate in terms of what agencies should do what.

But we are a USDA federal advisory committee so what are some of the
core competencies USDA has and getting folks more information about some
of those areas such as animal welfare and tracking and marketing issues
and then trying to add something to the public discussion around
governments and transgenic animals.

So, kind of trying to figure out that balance and add something new, new
insights to those deliberations. So, the committee discussed that last
time and trying to pin down the scope of our discussions and making some
decisions around we\'re not going to get into the research and
development pieces, we\'re going to focus on food animals for food and
non-food uses and trying to balance those, navigate those two areas of
federal oversight at large and USDA core competencies, how do we want to
proceed with our deliberations.

And that\'s still something that we\'re sorting through. The small group
had some discussions, tried to put some more clarity around that and
develop the outline partly as discussion, work plan piece, as well as a
potential outline for a possible draft paper that would include the
committee\'s work over the three meetings that we have to do our work,
at least through this Administration, and then sort through some of the
other pieces such as presentations.

Nancy had originally planned to give that presentation the last time.
The committee wanted to have an overview of what are USDA\'s
responsibilities based on their statutory authority and some discussion
around that. So she\'ll provide that presentation this morning, we hope.
We plan on having her here. And then also looking at some other areas
that the committee was interested in, including the Marketing Service
voluntary programs and then the tracking system.

And, so, those are presentations that will provide the committee some
more information and then add to background for our deliberations as to
what are USDA\'s core competencies, what do they do relevant to animals
broadly and then is there anything specific about transgenic animals
that we might discuss a little bit further to put some clarity around
those topics?

So, looking at the organization of the agenda it\'s very much working
through the two tracks of the discussion in terms of the broad context,
federal oversight, and then also some of USDA\'s core competencies and
providing some more information and discussion around that and the
opportunities for that.

And we talk a little bit about the \-- immediately after about the work
group conference calls and looking at those materials and focus an
additional discussion about the background materials and any questions
about those background materials and then the draft outline for a paper
and our deliberations and give you a little bit more information in
terms of how the thinking that was discussed during those calls and the
depth of the outline that you see as well as the copies in the back.

So, if you don\'t have it with you, pick up another one. We will be
talking about that this morning. After a break we\'ll have Nancy\'s
presentation on USDA\'s authorities. Again, you did receive her
presentation for a paper by her, but it wasn\'t too long after the last
meeting. And she will be elaborating on that a bit, her presentation and
discussion, and then we\'ll also have another presentation by Dr. Craig
Morris from AMS, Agricultural Marketing Service, on the authorities
related to marketing and animals and animal products.

So, you\'ll have an opportunity to understand a little bit more and then
we\'ll break for lunch and then come back for the committee\'s
deliberations. Depending on how the first stab at the outline and the
discussion of plans by the work group, how that goes, that will lead
into the discussion of elements of an ideal federal oversight system.
It\'s almost a road map. They\'re somewhat interchangeable terms, and we
need to get our terms clarified in terms of what we mean when we\'re
using those terms, and how that\'s going to frame our discussion and the
discussion of the clear road map section.

That is part of the words again used in the outline and just putting not
only some clarity around those terms but then getting into some of the
discussion as framed by the work group and building on the discussions
from last March. And then we will have a short break and then move to
public comments.

As Michael has already mentioned, we do have people who have signed up
so there are people intending to provide public comment. If there\'s
anyone else who would like to do that if you\'d please sign up and then,
again, as Michael has already stated, depending on the number of public
comments and how time allocates for that, we may come back for
additional discussions as a committee as we\'ve done in the past, but
we\'ll adjourn no later than 5:00 this afternoon.

And then tomorrow morning, we\'ll start up again at 8:30 and see where
we are based on today\'s discussions. We have another presentation on
APHIS authorities and activities and a National Animal Identification
System by Dr. Morgan and then we\'ll come back for our discussion,
deliberations and based on what we talked through today and then see how
it\'s allocated on time.

Hopefully, not only put clarity around our work plan but then also have
substantive discussions based on the information that\'s been provided
as well as any decisions the committee needs to make about how we\'re
going to proceed and then revisit what needs to be done between this
meeting and our August meeting. Our next meeting is scheduled for August
26th and 27th.

So, we\'ll get a sense of what needs to be done, any additional
information, or, other conversations we need to have. Are we going to
have work group discussions, those kinds of things, a work plan between
now and August, and then adjourn no later than 4:00 tomorrow. So, that
at that point when we do adjourn we\'ll have a clear idea of how we\'re
proceeding between this and the next meeting and have substantive
discussions over the next few days and build upon those as we move
forward.

And we are then at that point looking at just two more summary sessions,
the one in August and I think the tentatively set date is December,
right?

DR. SCHECHTMAN: Mid-December I think.

MS. DILLEY: And the committee will reach maturity. That will be our 21st
meeting. And we\'ll have a celebration. Maybe we\'ll get a ticker tape
parade, Mardi, that you\'ve been longing for. And adjourn and send you
all home with hopefully no travel problems that some of you have
experienced getting here.

So, any questions about the agenda or anything else over the next couple
of days? All right.

DR. SCHECHTMAN: Okay. Now the committee\'s actual work for these two
days is going to begin and we\'ll begin to consider how to move forward
on your work on transgenic animals. A considerable amount of work was
done at the last AC21 meeting and between that meeting and the current
one.

You will recall that at the last meeting the committee came to some of
provisional conclusions about the scope of your work on this project,
namely, that the efforts would cover food animals, whether engineered
for food or non-food use purposes and that the report would not attempt
to sort out all the gory details of which federal agency has the
strongest or most appropriate legal authority to address a particular
regulatory need.

Rather, the committee would focus on what needs to be considered in the
overall federal regulatory and oversight system while recognizing the
particular strengths and competencies we already have within USDA
agencies.

The committee also considered some of the elements that might be
included in such an oversight system using some materials developed
under the Pew Initiative for Food and Biotechnology as reference
materials. Additionally, the committee identified several topics on
which it requested additional background information to aid in its
deliberations.

And I and the facilitators have worked together and will provide that
information. I alluded to this information earlier but let me repeat
what you\'ve gotten and perhaps, as I remember it, why you asked for it.
Information on USDA\'s specific regulatory authorities granted under law
that are relevant to its activities on transgenic animals. This is the
paper that was developed by Nancy Bryson and she will speak to it and
perhaps expand on it shortly.

Second. Information on USDA oversight activities for imported animals.
These materials refer to both USDA\'s Animal and Plant Health Inspection
Service, APHIS, and Food Safety and Inspection Service, FSIS,
recognizing that some transgenic animals for products from them might be
imported to the U.S. rather than produced here.

Third. Information on USDA oversight of animals under the Animal Welfare
Act to see about the application of the AWA to livestock and existing
provisions relevant to transgenic animals.

Fourth. Information on the legal authority for and operation of APHIS\'
National Animal I.D. Program, how it works, where its authority comes
from, and what its current and future capabilities are. And, finally,
some brief background information on how an ethics advisory group in
another country, in this case the European Group on Ethics and Science
in New Technologies under the European Commission works, as a
contribution to your discussions about the feasibility and
appropriateness of discussions around the ethics of transgenic animals
in general or in specific instances and possible forums for that
discussion.

Now, in the time since the March 5th through 6th AC21 meeting a work
group consisting of Greg Jaffe, Alison Van Eenennaam, Randy Giroux,
Nancy Bryson, Steve Leath, and Jim Robl met, via conference call open to
the full committee twice, on May 2nd and again on May 19th.

You should have received meeting summaries from those calls and they are
of course in the pile of documents that you received and on the back
table. The aim of their conversation was to help frame the elements of
the potential discussions by the full committee at this meeting and
beyond by brainstorming any big-picture issues that the committee may
have overlooked and by developing the elements of a potential outline
for the committee\'s paper.

You will have by this time received two versions of that outline, one
after each conference call. The second one, largely a condensed version
of the first, which eliminated some of the ambiguities and redundancies
in that first one. I did some reorganization. That second document dated
May 20th is the one now being presented to you for your consideration
and it\'s the one that is on the table in the back.

Again, it\'s the work of a work group and it\'s up to the full committee
to decide whether it meets any of the committee\'s needs and what to do
with it, though, of course, we hope you find it acceptable as a starting
point. It would seem to me that it would make sense to consider the
outline in its broadest component first and then get down to particular
items or details afterwards, every specific thing in it, of course,
being up for discussion.

So, what\'s in the draft outline that\'s been offered to you for your
consideration? It has a few main sections. First, an introduction
describing the committee, your efforts and charge, and the scope and
context you have arrived upon which would in incorporation include
mention of four USDA competencies that are relative to the discussion.

This is followed by a topic section where the idea of your road map is
emphasized and where key elements of an oversight system are discussed
and where the distinctions between animals intended for food and those
for non-food uses are explored. Then the report will end up with closing
comments and recommendations that may pull in some of the knowledge
about USDA\'s strengths and competencies.

We know about the challenge of putting together consensus
recommendations as a committee. Let\'s see where you get to. In my mind
though there are several tasks before you at the moment. First,
considering whether the outline overall meets the committee\'s needs
recognizing that the specifics will, of course, will be arguable.
Second, assuming that it\'s considered a workable place to start,
considering how to additionally focus it so as to provide a useful
addition to other reports that have been previously developed in other
forums.

How to determine whether and how this group can add to provide the most
value? For example, the question will remain for the committee how much
do you want to reference other reports versus restate what may be
similar to what\'s presented here, a question for the full committee?

Next, of course, considering how to get the report written. This will,
of course, include some writing assignments but it will also include
again discussions on how to restrict how or what you say in order to
have a chance at finishing it in the time that we have. Next, deciding
how far you can go in terms of recommendations; something that is
unlikely, I would guess, to be decided until the very last minute.

Finally, based on USDA\'s authorities as a general matter, deciding how
the committee will split out and how it deals with animals for food uses
versus those for non-food uses. Will the committee decide that it has
more to say about one class versus the other?

Let me in closing here just reiterate that we at USDA are very
interested in new discussions as they proceed, but we really hope
you\'ll be able to pull off and get a report produced that incorporates
the diverse perspectives you all bring to this topic, hopefully with
some recommendations for us as well.

Those are just a few thoughts. What I\'d like to do is turn to the
members of the work group to have them add their views about what they
did and their thoughts on how to move forward. So, if I can turn to work
group members for comments to start us off that would be good.

MS. DILLEY: So, Greg, Jim, or Alison, if you want to add \-- we don\'t
have Randy or Nancy here, or Steve we do have. If any of you have
additional perspective to add to the discussion about the two conference
calls and the outline.

DR. VAN EENENNAAM: I think our intent was to bring it down to a chewable
size that we could get done in the two meetings and we\'ve got it to a
level now that we can actually get through in two meetings.

MS. DILLEY: Jim?

DR. ROBL: I guess I would \-- I think that that was one of the main
topics of discussion was, what is the scope and what topics can we cover
and actually come up with a paper within two meetings?

MS. DILLEY: Can you speak up a little, Jim.

DR. ROBL: And my view is, is that we\'re still way too broad and have
way too many topics to discuss and that we probably could have refined
the scope of our discussion to items that might be more specific for
transgenic than those animals in general if we are to accomplish our
objective and actually having a written paper.

MS. DILLEY: Greg, do you want to add anything?

MR. JAFFE: No. I mean, I would ask for the report at the last meeting
and I guess the point was just to give us something to work off of. We
tend to work better if we have something to work off of than to start
with nothing. So, that was the emphasis, to try to put some outline
together and to put some construction to the discussion and see where we
go so I think we did that.

I am of the view that things should be \-- we tend to look at things
more broadly and discuss more of the topics than try to get down to a
few topics. So, I don\'t think the thing is too broad because I think
we\'re not going to be able to get very down into the details for a lot
of these anyway.

MS. DILLEY: That continues to be our challenge in terms of do you go
broad and narrow or do you go more deeply into detail and more specific
and that\'s a perpetual challenge to the committee in terms of getting
our hands around our various charges we\'ve had over the course of the
committee\'s service.

So we continue to have work groups that tend to take what we\'ve talked
about in March, try to capture some of that, especially in terms of the
context and some of the scope pieces as well as some other pieces that
have been discussed and try to put it in at least a clear outline to
make the decisions around how we\'re going to go about doing our work
and not spend all our time talking about what we\'re going to talk about
but also actually have a conversation knowing that we\'re limited on the
amount of time that we have left to tackle this task.

So, having looked at that I think what might be helpful is just overall
general reaction to the outline and then maybe take it in chunks. Say,
introduction, it\'s more typical our \-- Nancy, you just walked in. We
just had the members of the work group providing a little bit more
context to the work group\'s deliberations and the outline so we covered
at least some of that.

I don\'t know if you want to add any of your thoughts in terms of the
outline. I\'m sure you\'ll chime in as we talk about it further.

DR. LAYTON: For the record, Nancy, please say your name out loud so that
our transcriber can get it.

MS. BRYSON: Yes. Nancy Bryson.

DR. LAYTON: Thank you.

MS. DILLEY: So, what would be helpful I think is kind of an initial \--
and this will be our first run at that, the outline. We wanted to get
you guys up to speed on what the work group had done during their two
conference calls and a little contrast to the outline and then go more
specifically into does this make sense in terms of our work plan and a
possible outline for a paper and I\'m using paper instead of report
because people always put bigger amounts of stuff into a paper anyway
than into a report so we\'ve been talking about this as a paper.

So, we have an introduction and then we have the topics and then we have
things like closing comments piece if you look at the broad outline of
it. And the scope is somewhat tied within the topics or elements of a
road map and the government and transgenic animals a little bit more
large and we had talked about that at the last meeting in March in terms
of not just regulatory but also marketing, ethical, other elements.

There are a range of things and we talked about that in a broader term.
So, you know, there are lots of different ways to potentially narrow
what we\'re going to talk about but we want to do it in a logical way
for the committee so we can tend to get our hands around the different
pieces.

So, what I thought we\'d do is at least have some initial reaction to it
and the committee having had a chance to explore a little bit more about
the group\'s discussions and insights and look at the outline now and
just kind of hold all reactions to it and then we can break it out into
the different sections, introduction, topics, and closing comments.

As those of you who have served on the committee before this is often an
interim process where we take a first stab at it and the decision
tightens up and we\'ll do that again as we go along over the course of
this meeting and then drafting a paper continuing of our deliberations.
So, I\'ll open up this meeting for any questions or reactions to the
outline, anything else as far as the introduction.

Stephanie.

MS. WHELAN: Having gone over it, I think that we\'re looking at the
broader piece of this outline. There might be some various other topics
or additions but in just looking at it in that overview sense I think we
can get through this simply because if we get into any of the specific
items then we might run into problems, but in terms of the presentation
like this maybe we want to add or subtract points underneath these areas
such as ethical, then I think it\'s doable.

But going down through the discussion individually I think we\'re going
to run into problems, but if that\'s looking at and then saying where
are the core problems with USDA are under these various areas then I
think we can.

MS. DILLEY: Other reactions to the outline? Questions? Michael and then
Steven.

MR. ENGLER: As to the scope I was a little confused and I wasn\'t here
what the purpose of not discussed was early research and development and
then other? Is this a placeholder?

MS. DILLEY: It\'s a placeholder. It\'s basically during our March
meeting we had talked about one way to decide what we\'re not going to
talk about is to talk a little bit about what you\'re not going to talk
about and then we had decided not to talk about early on the R&D
elements of transgenic animals and there may be other things that we
take off the table and I guess a piece of that is already in number 1 in
terms of what animals, transgenic animals are we going to talk about.

And we decided not to talk about insects and some other things so we
didn\'t elaborate on that but we more specifically wanted to focus on
food animals for food and non-food uses. So, yes, that was one of the
things as a placeholder.

DR. LEATH: Yeah. When we had discussions it seemed like a discussion
that was broad on purpose and tried to focus in and make sure we didn\'t
miss anything but when we get down to the non-food uses I was kind of
left with the impression we were going away from that area and
concentrating just on food uses. But if we go with non-food uses, does
that mean a husbandry issue that we want to discuss as a committee or
where are we going to focus on non-food uses if we even deal with it?

DR. LAYTON: Did the committee mean drugs, pharmaceuticals?

DR. LEATH: We were talking about transplants and things like that.

MS. DILLEY: Go ahead, Jim.

DR. ROBL: I guess my view on that is USDA has responsibilities and
activities for food animals that really don\'t have anything to do with
whether it\'s transgenic or not. For example, USDA is responsible for
animal welfare, implementing animal welfare guidelines, and so that
doesn\'t make any difference whether it\'s a transgenic animal or not.

Other things like disease issues in transferred animals across state
lines and so forth would be the same regardless of whether it\'s
transgenic animal or not. So, in some ways whether it\'s genetically
engineered, whether it\'s for food or non-food uses, and even non-food
animals could go into the food chain under appropriate approval.

So, my view is that you wouldn\'t necessarily sort those out unless you
expect that the USDA might be involved in the product that is generated
from those animals if it is a non-food product.

MS. DILLEY: So I think we were looking at food animals and we know that
it\'s produced for not only food uses but also non-food uses so the
section is kind of vague given that USDA has authority over animals then
they may have some \-- that may be relevant in terms of their intended
use so we kind of kept it broad and didn\'t necessarily make any
decisions about whether that\'s different or, yes, USDA would definitely
have a greater role or anything like that. It\'s kind of we were casting
a broader discussion based on their core competency and responsibilities
and look at additional insights to that I\'m sure after Nancy\'s
presentation.

Stephanie?

MS. WHELAN: Yes. I just had one question clarifying under context and
transgenic animals that\'s potentially broad. Does that include the
ornamental fish or not?

MS. DILLEY: I\'m sorry?

MS. WHELAN: Does that include the ornamental fish?

MS. DILLEY: You know, I don\'t know if that included the ornamental
fish.

DR. SCHECHTMAN: My sense is the only way, to the best of my knowledge,
that fish could conceivably have anything to do with USDA authority, and
I suppose you could speak to this more than I could, is that if they are
raised on farms and if the farms are aquaculture facilities. Otherwise,
they are not typically \-- they\'re not considered to be within any of
the authorities that I know of. Would you agree with that?

MS. BRYSON: I think that\'s probably correct, but it seems ornamental
fish somehow has a terrible disease that was going to infect every other
fish that lived in the United States raised for food then you the FDA
probably has the authority.

MS. DILLEY: So, it\'s type of production in aquaculture or the potential
test.

MS. BRYSON: Or a different test.

DR. LAYTON: Can I ask a clarifying question? So, that eliminates all
wildlife as endangered species so USDA has no authority at all over
this. I\'m just making that clear.

MS. BRYSON: Oh, absolutely.

MS. DILLEY: Does anybody have any overall reactions to the outline?
Steven?

DR. LEATH: USDA regulates wildlife grown for food same as they do
aquaculture and that\'s how when you have game farms typically for meat
production that they were handled similarly like cattle or something,
isn\'t that correct?

DR. LAYTON: Yes. I think if you\'re growing

like \--

DR. LEATH: Deer.

DR. LAYTON: But you don\'t grow them for food, you grow them for
shooting and I don\'t think they\'re regulated. Well, if it\'s grown for
food then, yes, but if not, if they\'re grown just for shooting \--

DR. LEATH: Right, I\'m just saying when you grow them for food like on a
farm or quail or something.

DR. LAYTON: Quail, yes.

MS. DILLEY: Greg.

MR. JAFFE: I don\'t think the issue is going to be USDA\'s authority or
not. The charge is to say, okay, there\'s transgenic animals coming
along, what are those transgenic animals and what\'s USDA\'s role
regarding those and I mean for clarity last time that we shouldn\'t read
regulatory very narrowly but read it much more broadly and clearly what
USDA is doing a whole lot on cloned animals that aren\'t within any
specific regulatory authority at this point and the statute that talked
about overseeing the safety of those cloned animals per se. Whether we
have, I don\'t think that was our issue.

So, maybe that\'s \-- to me, I think our cut should be what are the most
likely sort of applications of transgenic animals that are going to be
\-- that might be commercialized in the near future and what those kinds
of animals really are and, therefore, what is the appropriate government
role regarding those and, yet, use regulatory in a very broad sense
including the commercial like marketing and some of these other kinds of
things, not just purely environmental or food safety.

And the discussion here sounds like what we\'re getting at or what is
the \-- unless there\'s a specific cut we shouldn\'t talk about that
kind of application and I guess I don\'t agree with that. I think we
should look at the applications. For transgenic fish I think is one of
the most likely applications.

We might decide that USDA doesn\'t have a lot of core competency there
or not a lot of like legal authority there to do some of the safety, but
my reading of the charge is it says that \-- I mean the charge, I know
we all haven\'t agreed to, says, you know, FDA is going to regulate
these animals \-- transgenic animals after some opposed, under whatever
approach they do what\'s the appropriate regulatory role for USDA for
transgenic animals.

It doesn\'t say that, you know, we\'re only going to limit ourselves to
the ones that USDA. We could say that USDA has no regulatory role for we
don\'t see much of a role for them.

MS. DILLEY: I think that\'s the idea and then we were just kind of, just
as we always do, we have to kind of get ourselves grounded and we did
make some decisions about non-food animals, the sort of across the table
and trying to figure out well what was the \-- what were some of those
decisions, but in terms of our charge it was more broad in terms of what
federal oversight and then USDA within that context.

MR. JAFFE: Right. I mean, I\'m comfortable with taking off non-food
animals from our slate, but that decision may not be based on legal
authorities. It\'s based on the fact that taking away the extra piece
around this committee or do we think it\'s \--

MS. DILLEY: Exactly.

MR. JAFFE: \-- the public may be more concerned about it and the
government should spend its scarce resources or other reasons why we
want to do that, but I don\'t believe we did it based on a legal
analysis of where they did or did not previously regulate.

MS. DILLEY: Right. So, other comments? Stephanie? Larisa?

DR. RUDENKO: I have a question, and I apologize because I\'m new to the
committee. Somebody talked about transgenic animals?

DR. SCHECHTMAN: Let me just answer that. I mean, we\'ve been talking
about using transgenic loosely. We\'ve been typically about genetically
engineered animals.

MS. DILLEY: Mardi.

DR. MELLON: I was looking at the outline and I\'m wondering where, if
anywhere, there\'s the notion of imported. You know, I know there\'s a
background discussion of import authority but it seems to me that when
we talk about marketing, the assessment of the impact on the
international and domestic markets.

MS. DILLEY: I\'ve got text under that particular topic under marketing
and free trade. We had that broken out in quotes and broken out after
the first discussion and I think there was some discussion about it last
March and it got tucked under there. You, of course, don\'t see that
because it\'s not there, but I think that was our discussion as I recall
at the last \-- on the 19th.

DR. MELLON: I think that probably ought to be resurrected and given a
bullet point if we\'re going to talk about it because it\'s quite
different to, you know, acknowledge that there are going to be products
coming into our marketplace from somewhere else that need to be dealt
with as opposed to assessing as they are trying to do in the country
context, for example, the impact of having these unregulated animals,
you know, on our ability to kind of contract trade with other countries.

MS. DILLEY: So, Michael?

DR. SCHECHTMAN: I was just going to say at this point that probably
could be stuck under two places. One is under trade and the other is
under food safety determinations and presumably under regulatory
elements.

MS. DILLEY: Yes?

DR. MELLON: Just break it out. I mean, it\'s an issue that if we\'re not
going to talk about it we should just take it off the table as part of
our scope of discussions so we\'re not really going to talk about the
imported animals that fit under whatever our scope is.

MS. DILLEY: Michael.

MR. ENGLER: I was just struck when we were doing definitions what\'s the
definition of a food animal. Animals that some people will eat or most
people think will eat or what? I think there\'s a lot of possibilities
there.

DR. SCHECHTMAN: I mean, I think what the committee was \-- the committee
sort of came down to last time was sort of commonly eaten food animals I
think was the sort of general sense that people were talking about which
is to say there was some folks said, you know, there\'s a research
that\'s being done on the engineering, for example, on shrimp and people
eat shrimp. Whether or not they\'re farmed, they\'re a common food
animal. On the other hand, just because there are a few people in the
country who may eat squirrels \--

MS. DILLEY: You have animals in a group, if you will, that are being
raised for food.

DR. SCHECHTMAN: But you know, nothing, but just a few people, just sort
of recognizing that the committee is not going to be able to cover
absolutely everything that it can in a relatively short period of time.
It\'s talking about pretty much common food animals and USDA\'s part of
that is livestock, of course, but recognizing that the committee\'s
going to be going a little more broadly than that in some of the broad
analysis.

I think that was the sense from last time. Welcome to be corrected.

DR. LAYTON: Are horses common food animals or not? Let me ask that
question because that\'s a specific domestic animal livestock and I
don\'t know the answer.

DR. CARDINEAU: Only if you\'re a dog.

DR. LAYTON: A dog.

DR. CARDINEAU: Dogs, they make dog food from \--

DR. SCHECHTMAN: Well, I think it was \-- yeah, well.

MS. DILLEY: Carol?

MS. TUCKER-FOREMAN: Is there a definition of food animal under the
Animal Welfare Act or in the Animal Health Act?

MS. DILLEY: I think we keep nibbling around it so we might drop it.
Marcia, did you have a question before we move to Nancy.

MS. HOLDEN: Would it be useful to make a list of what is either what is
now or what is going to be put under development in terms of genetically
engineered food animals?

DR. LAYTON: We had that list at a presentation in December. Who did
that? One of you all did that.

MS. DILLEY: Jim.

DR. LAYTON: Yeah, Jim did it.

MS. DILLEY: Yeah, so we need to go back to the list. It\'s just a
technical thing.

DR. LAYTON: Yes, we have it.

(Discussion off the record)

DR. LAYTON: Do we need a break? We were supposed to have a break before
\--

MS. DILLEY: Let\'s take a five-minute break so we can make sure \--

DR. LAYTON: Five minutes.

(Whereupon, a brief recess was taken)

DR. SCHECHTMAN: So now we will reconvene. I\'m happy to introduce Nancy
Bryson, our committee member who is going to make a presentation on USDA
legal authority that\'s relative to transgenic animals. Nancy, thank you
very much.

MS. BRYSON: You\'re welcome. I\'d just like to start out by saying I\'ve
searched through legal authorities real hard looking for a way to say
USDA should be in charge of engineering deer to prevent them from eating
garden plants, based upon the study of biotechnology funds. I discovered
they were all missing. I\'m still working on that part.

And I guess I would like to start with the disclaimer that these are my
own views. These are not the views of the department and so with that
I\'ve made the list and so they look very familiar to us on paper that I
think Michael circulated that I did about a month ago. It is simply
intended to be a review of the authorities that relate to animals that
might possibly be involved in this topic area and, of course, may be a
consideration for the committee\'s consideration.

From an overview perspective, what we have here is a basketful of
authorities of various kinds which belong to USDA. USDA has something
like 400 statutes and we have a few here. They\'ve been added to the
USDA legal portfolio since the beginning in 1861 and so if you really
need to find authority for something you usually can find it in some
statute that\'s still on the books.

But for our purposes, the way USDA asserts authority over animals now
falls in one of these five topic areas. It has regulatory authority for
food safety in its Food Safety and Inspection Service and this is for
the food safety of meat and meat products; that is, products that
contain anything over 50 percent meat. Those are all regulated in a
system separate from the one that\'s run by the Food and Drug
Administration with one exception.

The definition of what is prohibited or branded in the Federal Meat
Inspection and the Poultry Products Inspection Acts were defined as,
misbranded and adulterated, things that could not comply with FDA
requirements for additives and those other sorts of things that FDA
regulates. We\'ll talk about that a little bit more.

Another arm of USDA, the Animal and Plant Health Inspection Service has
a very big job of safeguarding plants and animals from diseases and
safeguarding health. APHIS also administers the Animal Welfare Act which
essentially provides for humane treatment of the animals involved in
research.

The Agricultural Marketing Service, on the other hand, represents the
other major hat that USDA wears. This is not a regulatory hat, it is a
marketing hat and there are a number of statutes that were adopted in
the 1940\'s. AMS has the authority to create any kind of a marketing
program that will help promote agricultural products.

And, finally, USDA has many, many research authorities that are run
through the REE Section of USDA. The Agricultural Research Service,
CSREES which handles extension is the Economic Research Service and the
National Agricultural Statistics Service are constantly engaged in doing
all sorts of research in many different areas for the improvement of
agriculture.

And, finally, and this is a really important point that I put in,
thinking about Greg\'s comments about what USDA\'s regulatory
authorities are in addition to the ones that we traditionally think
about as regulatory or marketing and that\'s the consultative role of
USDA, w,henever there\'s an issue that has an effect on agriculture,
USDA is consulted because it is viewed as the arm of the executive
branch that speaks for the constituency and, so, it can be an issue in
which USDA has no regulatory authority over. You know, it could be an
environmental issue or something like that, but to the extent
agriculture is mostly affected by solutions, programs, other things that
are developed, USDA is consulted to make sure that there\'s a voice for
views being expressed and so that consultative role is one that I think
is important for the committee to keep in mind as we think about the
interstices between these authorities where you may not see something
that\'s specific but if it\'s an agricultural \-- if there is an
agricultural impact there is a role for USDA.

The safety of food products from animals. This is regulated under a law
called the Federal Meat Inspection Act. And the requirements are that
meat and meat products be safe, in other words, not adulterated or
misbranded, very similar to the standard that FDA enforces for other
kinds of food.

A product would be adulterated if it contained any poisonous or
adulterated substance that would be under the FFDCA so a color additive,
a food additive, a drug residue, it would be adulterated if it was
produced under an unsanitary condition or from an animal that died other
than by slaughter.

A product is misbranded if the label is considered to be false or
misleading. There are a raft of statutory definitions which are written
into the law including things like the fact that you have a chemical
preservative in a product that has to be on the label or the product
would be considered to be false or misleading.

And many of the statutory provisions stem directly from situations like
those described in [The]{.underline} [Jungle]{.underline} or at a point
in time Congress decided it was going to qualify certain things that
were required to inspect meat products or the disposal of them. And then
there are many other regulatory definitions that are more modern that
have been added, statutes during the 70\'s, 80\'s, and 90\'s to address
current marketplace issues like, what\'s a fresh product or what does it
mean to be produced on the farm?

The terms of implementation. There is a process of continuance in plant
inspections of both broader plants and production facilities. There are
HACCP requirements which relate to the hazard analysis and critical
control points, review of the food production process and appropriate
intervention steps at each point where a hazard is identified.

There is a process where we deal with pre-approval of product labels and
USDA has authority for enforcement activities. Also, those are
administered through regulations, policy, guidance, and directives. In
terms of its importing requirements we have something called the
equivalency requirement and again in terms of imports FSIS and USDA
operate somewhat differently than FDA does.

The basic requirement is that imported meat and meat products have to
meet USDA safety standards and that\'s the same as the requirements for
food, but because of the unique nature of the meat and poultry
inspection processes and the safety standards there are some
differences.

The standards of the exporting countries do not have to be identical to
U.S. standards but they have to be equivalent. This is a term of art
that comes from the sanitary inspection and sanitary standards agreement
of the World Trade Organization and FSIS is the agency that\'s
responsible for determining whether a comparable system in a foreign
country is in fact equivalent to ours and therefore the products from
that country should be eligible for import.

There is a regulatory process for determining equivalency that includes
a set of evaluation criteria for the system in the other countries and a
process. In terms of the system evaluation for those who might be
familiar with the way State programs are created on the departmental
side it is a similar type of process.

FSIS conducts a review of the system. It\'s really a documentary review
to look at the organizational structure and the staffing that exists in
the foreign country. There\'s a requirement that there be national
government controls of the whole system. There has to be a series of
competent, qualified inspectors who are often available to do the job.
The country has to have an enforcement system and responsibility and
there has to be at the same time an inspection, sanitation, residue
standards that are applied to products in the U.S.

In looking at the legal authority, there has to be a match upon that
side too. There has to be a process for ante-mortem inspection under the
supervision of a veterinarian. There has to be post-mortem inspection of
carcasses. There has to be official controls over facilities equipment
and these are essentially standards. There has to be direct and
continuous official inspections. The establishment of certain type of
export has to be separate from those that are not and the sanitation
requirements and HACCP standards also have to be met.

The process basically is that the review is initiated at the request of
the foreign government. A documentary analysis is conducted as their
items have been discussed in the previous two slides and there is also
an on-site inspection by FSIS and periodic follow up compliance
inspection. Once a determination is made that a country has a system,
standards which are equivalent, it\'s not automatic that every plant in
that country gets to export to the United States.

Each individual plant must also be certified for export and imported
product coming from those plants has to be inspected either at \--
either on the basis of a specific export and official establishment or
an import inspection establishment. FSIS agents refer to these as
I-houses. You may have heard that term.

Sanitary certifications can be suspended at FSIS\' discretion if there
is a problem. The whole system that I\'ve just described by FSIS is
dependent on standards. So, for it to relate to animals which are
genetically engineered in some way a standard would need to exist,
whether it\'s an FDA standard or a FSIS standard, or something like that
because that\'s the way the whole system operates.

Turning to APHIS, the animal health and safeguarding authority, these
are found in the Animal Health Protection Act which was updated in 2002
and the authority that APHIS has under this statute is very broad, one
of the broadest types of authority that are conveyed by Congress to
grant authority to an Executive branch agency. This authority is to
prohibit imports, exports, or interstate movement of any animal,
article, or means of conveyance or use of any means of conveyance or
facilities if the Secretary determines that it is necessary to prevent
the introduction or dissemination within the United States of any pest
or disease of livestock.

And also the safe quarantine or disposal of any animal, article, or
means of conveyance as necessary. These concepts are very broad
authority to a degree of concern that exists about what would happen to
U.S. herds which I\'m not sure what the number it is now, but a few
years ago it was 96 million head of cattle in the United States.

It had a tremendous economic impact, negative impact when diseased
cattle we don\'t have in this country were introduced, so USDA often
needs to require very simply group quarantine through State veterinary
and local authorities to control the spread of disease.

The legal definitions of all of these terms and their legal definitions
that we just read about what the authority is are all relevant.

Animals. We\'ve had several discussions on what the animal means and
you\'ll see that animal is defined differently in these various statutes
we\'re talking about. Animals here is any member of the animal kingdom.
An article is any pest or disease or any material or tangible object
that can harbor a pest or disease.

About means of conveyance, any personal property used or any other
personal property to move your plants. Your pest. A path is a protozoan
plant, bacteria, virus, infectious agent, arthopod, parasite, prion
vector, or similar allied organisms. I always have time to define an
allied organism. A disease is defined by USDA as anything that USDA
decides that can essentially be defined for purposes of this statute,
and livestock relates to all farm raised animals.

Let\'s go back for a minute to look at the definition. USDA has
authority to prevent movement of any animal, remember, anything in the
animal kingdom, but a human, but the purpose for which it controls those
is to prevent introduction or dissemination of any pest or disease of
livestock or farm-raised animals. And that\'s the important thing to
keep in mind about this statute is the protected actions that USDA takes
relate to the protection of farm raised animals and livestock.

For example, when we had an Exotic Newcastle outbreak in the United
States that was very serious in 2002 or \'03 I think it was, USDA vets
were going around the Los Angeles suburbs collecting fighting cocks and
killing them along with backyard birds, not because they were being used
for food production, but because they were a vector of diseases that was
a big threat to commercial poultry industry. So, that's sort of how
these things stick together.

The purpose of \-- and often when you get into a new area the purpose of
the statutes when looked at are to think about how the regulatory
programs evolve or might develop. The purpose of the Animal Health
Protection Act is very broad. Obviously, to protect the animal\'s
health, but also to protect the health and welfare of people, the
economic interest of livestock and related industries, the environment
of the United States in interstate commerce, and, for commerce and
animal survival.

There is a very close linkage between what we do in the U.S. with
respect to inspection of plants and animals and on the animal side with
the OIE, which is the World Organization for Animal Health. OIE is an
organization that was first created in 1926 when a group of vets from
different countries came together for the purpose of sharing information
about outbreaks of potential disease in order to try to prevent the
movement globally, keeping in mind it\'s much more important today in
the global society that we live in.

And OIE\-- and the U.S. plays a leadership role in OIE through APHIS.
It\'s very focused on creating risk-based criteria for trade in animals.
So, it has been used as a basis for proposed U.S. standards. The best
example of that is our revision to SPS standards where one BSE was found
in this country we determined that maybe it wasn\'t necessary to have a
wall go up and to say we\'re not going to do trade with anyone that has
any degree of BSE so we moved into the categorization of identifying
some countries that were at moderate risk, minimum risk, great risk, and
I don\'t think great risk was in there, but you know, substantial risk,
and had the different types of trade groups and different kinds of
products for those purposes.

A very important component of OIE\'s risk-based criteria for making a
determination about trade relates to the animal identification and the
animal traceability systems and it was really when BSE came to this
country that we began to get very serious about the tracking and
identification of animal traceability for trade purposes because the
animal that first came to us from Canada from a herd there with BSE were
quite difficult to trace.

It took a long-term epidemiological investigation to find those animals
and the calves those two components and when you look at the OIE Code of
Terrestrial Animal Health which is their governing set of legal
documents, you consistently see animal identification or animal
traceability as essential tools in their mind.

And OIE traditionally has not addressed the animal production food
safety, a few years ago it did adopt a resolution saying hey, we\'re the
vets and we\'ve got to be part of this and they are engaged in a process
of looking more closely at food safety, how that relates to the other
international food safety reference body, CODEX, something that they\'re
all working on in July, interesting discussions about that.

Animal welfare is another area in which USDA has substantial authority
and Carol asked a question on what the definition of animal is for this
purpose and it is, first off, any live or dead dog, cat, monkey, et
cetera, or other warm-blooded animal as the Secretary may determine
being used or intended for use for research, testing, verification, or,
exhibition purposes.

So, research, testing, verification, or, exhibition purposes. There is a
big exclusion that comes right after the definition of animals. And the
exclusion is for other farm animals such as, but not limited to,
livestock or poultry used or intended for use as food or fodder, or,
livestock or poultry used or intended for use for improving animal
nutrition, breeding, management, or production efficiency, or, for
improving the quality within the food or fodder.

So, Animal Welfare Act does not apply to farm animals. It could apply to
such animals being used in certain types of laboratory research. There
are requirements for the humane treatment of animals used in laboratory
research and FSIS regulations, to the extent they address those food
animals that are used in research, excluding food animals used in
research investigation for experimental drugs, et cetera from slaughter,
although there are a few risk-based exceptions which could be applied
under which the animal might enter the food supply.

Something that is not often talked about is that when people talk about
the Animal Welfare Act is that there are also some humane slaughter
requirements which do apply to animals in the slaughterhouses for food.
There\'s a lot of interest in those provisions but I didn\'t discuss
them.

Okay. Turning away from regulatory authorities, safeguarding authorities
to marketing, labeling, process verification. We\'re going to have a
talk later on today from Craig Morris who is with the livestock and feed
group from the Agriculture and Marketing Service and he\'s going to
answer all the hard questions you may have on this program.

But just in terms of laying out what USDA\'s legal authority is, the
Agricultural Marketing Act is the one that I mentioned from the 1940\'s.
It\'s also got a lot of good language in it. It\'s designed and it\'s an
integrated administration of all laws enacted by Congress to aid the
distribution of agricultural products through research, market aids and
services, and regulatory activities to the end that marketing methods
and facilities may be improved and that new and wider markets for
American agricultural products may be developed both in the United
States and in other countries, with a view to making it possible for the
full production of American farms to be disposed of usefully,
economically, profitably and in an orderly manner. So, just about any
product that you can think of that you couldn\'t find a market for I
think there might be a market for, if they asked USDA to create a
process of verified programs for you which identifies the criteria that
Americans now crave, and creates an audit process which AMS will do for
you based on you paying a fee to them to validate your production
process and authorized to develop and approve standards of quality,
condition, marketing, grade, and packaging.

For a long time this related to beef grading standards and 100 percent
Angus flanks and things of that nature but more and more you see it
being used for production crop-type grains such as grass-fed,
naturally-raised. There\'s a mistake in the paper that I circulated
through Michael that said that the grass-fed standard was still under
consideration. Actually, the grass-fed standard was finalized last fall
and I\'m going to update the paper so it states it correctly on the
website.

And it essentially is a standard that says that beef carrying that claim
has been raised on grass except for whatever milk it consumed when it
was a baby calf, doesn\'t have to be from pasture *per se*. That\'s one
of the big issues in terms of pasture and a certain percent of it has to
come from pasture and AMS decided in that Federal Register notice, which
is quite interesting if you follow the news issues, that given the
regional differences in the United States in terms of availability of
pastures throughout the year, the standard is going to be based on
either pasture, or silage, or that kind of stuff, no grains except for
incidental grain there is if there was an emergency situation.

But it took five years to get that claim sorted out through the public
comment process. Naturally-raised is in the process right now. It has a
lot of controversy as well around it, but USDA has a proposal out and
people are commenting on it. The participating producers in these
process verified programs paid a user fee for AMS review and the audit
process that supports the verification system. And they tend to be
rapidly developed to address market needs.

These are voluntary marketing claims so unlike what happens when you go
into the formal regulatory process where you have two years and up every
time you go through all the procedural requirements and outside ruling,
is this kind of a process verifying something that you can get developed
very quickly. An excellent example of that is what happened with the
process with the export verification system that was developed for those
countries that were still expecting beef from us after the discovery of
BSE. It probably holds the record of a couple of weeks from exception to
being able to audit and verify those standards.

We also have talked in the committee about the Organic Food Production
Act and I thought I would just include a little bit of discussion about
this. It is also administered by AMS but unlike the statutory authority
that we looked at under the Agricultural Marketing Act the Organic
Program has its own statute, The Organic Foods Production Act.

This Act was adopted by Congress in 1990. It\'s for the purpose of
getting some conformity among the rising different state or community
programs. And, so, Congress gave USDA the authority to establish
national organic production process standards intended to assure
consumers throughout the United States that there are consistent organic
standards and to facilitate interstate commerce in fresh and processed
organic foods.

So the Organic Food Production Act created a national certification
program, the national standards adopted at the federal level by the
national organic program which you see in the CFR are applied to
individual farming operations which vary by region and by nature, and an
organic systems plan that was developed with a USDA accredited
certifier. So, USDA is, accredits certifying agents. Sometimes those are
State, and they can also be private entities, the certifiers that work
with the individual farms in developing an organic systems plan which
spells out exactly how production is going to happen on that farm. And
the system does apply to livestock and poultry. When you look at the
regulations of the federal CFR you see requirements relating to, for
example, feed, health care practices, and living conditions and
genetically engineered animals would be not permitted under the origin
provisions of this, although as Greg and I were discussing yesterday
there\'s different discussions going on around cloned animals as to
whether cloning animals or progeny of cloned animals might be eligible
for this program in terms of that, I think he could tell us would need
to be reviewed through the National Organics Standards Board, which is
kind of a policy body that advises USDA on these issues.

Country of origin labeling. Another kind of labeling which is
potentially relevant to our discussions here. It was added to the
USDA\'s authorities in the 2002 Farm Bill for various kinds of food
products. Really only implemented with respect to fish because of
several appropriations riders. The 2008 Farm Bill extends the provision
to go to chickens and adds on some more specific direction to USDA about
when a product can contain or can be labeled "U.S. country of origin."
That product has to be from animals that were exclusively born and
raised and slaughtered in the U.S. It had to deal with multiple
countries of origin. Essentially it would be permissible to just name
all such countries on the label.

I\'ve only done the research authorities and these authorities are
institutional in nature and they are the ones pursuant to which all of
USDA\'s research and education program area conduct a wide variety of
research and extension systems.

You may see an interesting similarity between the objectives of ARS and
the Economic Research Service and here are a couple of them. They offer
support into issues that are current in USDA. For ARS it\'s ensuring
high quality safe food and other agricultural products, inspecting
nutritional needs, sustaining a competitive agricultural economy,
enhancing the natural resource basee and the environment, and provide an
economic opportunity for rural citizens and communities.

If we look at the role of ERS, you\'ll see a lot of similarities but in
different order. Competitive agricultural systems, safe food supply,
well-nourished population, harmony between agriculture and environment,
and enhanced quality of life for rural areas. The difference between the
two is that ARS is basically doing hands-on research and research
experimentation and things like that and working with land grants,
universities overseeing grants and things like that.

ERS is much more of an economic, as it suggests, Economic Research
Service. Constantly turning out programs on what\'s happening from an
economic perspective, evaluating the various programs that USDA runs,
looking at foreign trade issues and identifying opportunities for new
markets, and crunching the numbers to see where new opportunities are.

CSREES, State Research and Extension Service, and then NASS which is US
agriculture statistics, which are closely watched by everybody in order
to be able see what\'s going on. And that\'s it. I\'ll be happy to
answer questions.

MS. DILLEY: Mardi.

DR. MELLON: I\'d just like to ask whether there\'s a reason for not
mentioning FSIS\' labeling authority because a number of other labels
was mentioned somewhere in the background materials and that really
isn\'t a processed verified label as I understand it. But that and NEPA.
There\'s no mention of NEPA at all. Maybe it\'s not considered an
authority but it certainly is a relevant extent.

MS. BRYSON: I didn\'t go into the FSIS pre-label approval process more
than to say it is there. But you raised a very interesting question.
It\'s probably a topic that would be useful for more discussion, Mardi.
We never had a NEPA claim. It\'s actually an AMS claim.

DR. MELLON: There\'s no process. I wish it was developed. There was no
proposal.

MS. BRYSON: Never, ever. Well, no antibiotics ever, no hormones ever,
and no \--

DR. MELLON: Animal by-products.

MS. BRYSON: \-- no animal by-products. And it applies from the period of
birth to slaughter. If you look at the AMS website it appears right now
to be on a livestock claim, not a poultry claim. But we can ask Craig
about that. And that it\'s something that you\'ll see reflected if you
notice them coming out about the voluntary claims like the
natural-related claim and the intention is that FSIS as a food safety
agency with mandatory regulatory authority.

As I understand it, it doesn\'t or has not in the past felt that it
should say only people who use voluntary processed verified claims can
have those on FSIS products so FSIS has the door open to production
process claims that it would be potentially verified but in the scenario
of a lot of confusion which that we\'ll be hearing more.

DR. MELLON: Just one last point just for clarification because I think a
lot of people are interested in USDA\'s welfare authority. Now, it is
clear that any producer that seeks an organic \-- seeks to sell a
product as organic, you know, submits himself to standards requiring
that they establish and maintain preventive livestock health care
practices such as selecting livestock suitable for site-specific
conditions and resistance. They must also provide living conditions that
allow for exercise and freedom of movement, reduction of stress,
accommodates health, and natural behavior.

There is, except for farmers in that program which is voluntary, there
is no equivalent authority that applies to farmers in any other sense.

MS. BRYSON: Not that I know of. I could be wrong. I don\'t know, Mardi,
but not that I know of.

DR. MELLON: That\'s just a huge \-- I mean, I would think it\'s
surprising to a lot of people there's that lacuna and those kind of
freagmented authorities that you have to work with.

MS. BRYSON: Let me answer the question on NEPA, the second part of your
question. I didn\'t outline either NEPA or the Endangered Species Act or
any of these other procedural statutes which the government has required
to comply with when it undertakes a federal action, a major federal
action.

But NEPA is a very, very important step. It\'s important for this reason
I think. It is \-- it does not itself impose any requirements, but it is
a procedural statute that requires the government to look at and
consider environmental effects of decisions that they make. You know,
primarily it\'s going to advance to the development of case law because
the only international regulations are the original ones that the
Council on Environmental Equality adopted in 1975. And, so, the
obligation of the government is to evaluate environmental impacts and
explain what they are, if they are going to be significant and to
require them to do an Environmental Impact Statement. Otherwise, the
government doesn\'t have an effect on those requirements and impact.

Clearly, on the plant side of that side there\'s been several cases like
the Geertson case where the courts have found cases that said to date to
be not satisfactory in terms of NEPA obligations and I would expect that
we will see more and more NEPA litigation because while courts are
relatively sanguine about the growing scientific expertise at expert
agencies, they have no problem with looking at procedural requirements
and saying aha, you know, I don\'t think that that was a good
explanation for that type \--

DR. LAYTON: I just want to follow up to a question that Mardi asked
earlier if you don\'t mind. We recently had a case in our State where a
Deputy Commissioner of Agriculture was found abusing animals on his
farm. Now, he\'s in jail or he\'s paid a fine. Someone has control over
that. Is that at a State level because that is a livestock growing
system?

MS. BRYSON: Very well could be at a State level and Adrian might be a
good person to answer that, but for example, in the Hallmark situation
which a lot of you are familiar with, it was a State prosecution and
criminal prosecution of the employees under State law.

Adrian, can you shed any light on this?

DR. POLANSKY: Well, if we\'re talking about the national environment
that was raised in, I believe it was Kansas and the Animal Health
Department has authority and oversight of an issue whether it\'s the
animals aren\'t being fed appropriately or whether it\'s management \--
I mean, it had to go to the proper board. But I think that\'s similar
and the States have upheld, you know, about all States in the sense that
\--

DR. LAYTON: They clarified it. There is legal authority of some type
over those things but they\'re more likely at a state level. Thank you.

DR. POLANSKY: Yes, I believe it has.

DR. LAYTON: Thank you.

MS. BRYSON: Michael, you might want to correct that.

DR. SCHECHTMAN: Okay. I will do that.

MS. DILLEY: Carol.

MS. TUCKER-FOREMAN: Yes. Nancy, in your remarks but not in your paper
you made reference to the fact that FSIS will consider a product to be
adulterated if it contains food additives or chemicals or drug residue
and then it\'s not approved by the FDA. In practice, what USDA does or
what FSIS does there is strictly administrative. FDA determines what is
a poisonous chemical and FDA determines the amount of risk required to
make it adulterated and FSIS merely administers whatever FDA has found
in that regard.

And the other point. The Meat and Poultry Inspection Act preempted any
State law that is different in any way from the Federal Meat and Poultry
Inspection Act, unlike the Food and Drug Act in that regard. No State
can have less \--

MS. SULTON: Any further questions for Nancy? Yes, Alison.

DR. VAN EENENNAAM: Yeah. I just wanted to follow up. You said that with
regard to transgenic or genetically engineered if there was going to be
regulation it would have to be a standard I think from coming in and
going out so could you clarify exactly what that would mean? So you said
you could have an FDA but didn\'t really \-- I\'m not really sure what
you meant by that.

MS. BRYSON: Well, the system is, I think, not set up to distinguish
genetically engineered animals from another one unless they\'re a
different animal or unless there is a regulation for the clearance
process for determination by FDA that might apply to this provision. I
don\'t know.

MS. SULTON: Carol.

MS. TUCKER-FOREMAN: I actually had a question that\'s very similar to
that and I forgot to ask it. In the absence of an FDA decision on the
safety of transgenic animals, would FSIS accept as faith of transgenic
animals produced in another country? And that is a question that I
don\'t know the answer to.

MS. BRYSON: It is a question and I think we have to answer it is to look
at where in the system that I described approving this process for
taking animals into our system that would become apparent. If it\'s not,
if it\'s not some way to know that, FSIS isn\'t going to figure it out.
It goes through the process as it happens.

MS. TUCKER-FOREMAN: Yeah. It would have to be, I think, somebody saying
we are producing the first transgenic such and such and proudly
slaughtering it and presenting it for sale.

MS. BRYSON: One thing I think that would be considered in the process
and certainly FSIS, with existing regulations, is that animals, food
animals that have been the subject of experiments are not going to be
allowed, carcass for slaughter unless they can come under these
risk-based criteria and so they would need an evaluation process for
that.

MS. SULTON: Alison.

DR. VAN EENENNAAM: So I guess the fish coming in from another country
it\'s because it has been genetically engineered for that growth
activity, and it\'s experimental animals, even if it\'s not really the
one who had developed it.

MS. BRYSON: Unless FDA has said that it\'s safe for acceptability then
it\'s okay.

MS. TUCKER-FOREMAN: FSIS doesn\'t regulate fish.

DR. VAN EENENNAAM: Well, let\'s make it a chicken then. But so the FDA
\-- let\'s make it Australian lamb. If that was true they\'d have to go
to the FDA first, is that how it works, to bring a dead leg of lamb
that\'s, I don\'t know, genetically engineered, they\'d have to go to
the FDA first, is that the point that you brought?

MS. BRYSON: It\'s not clear.

DR. MELLON: It\'s absolutely not clear at all.

MS. BRYSON: I think it was a lamb that had been lost in an experiment.
You would think that under the system that I described, FSIS has the
regulation and review to determine and make sure that Australians don\'t
work under this provision. It was just reviewing animals that had been
used for experiments that would include animals in the food chain. That
would be one. That would be one possibility. Second possibility would
be, let\'s suppose, Australia had decided that this particular kind of
genetic classification or engineering is fine, there was no food safety
issue and it lets all these lambs into the process, but also it seems to
me would be a decision that\'s enshrined in their food safety system,
which would be a review at the time the equivalency decision was made
and FSIS would say yes or no, and maybe it would just certify plants
that were not using those type of lambs.

DR. VAN EENENNAAM: So would the change of production practices in the
country have to get it reviewed every time by FSIS because once you\'ve
been approved it\'s not a blanket approval.

MS. BRYSON: Well, they won\'t put it through the system, FSIS, for a
long time and at the time that FSIS made a decision about equivalency it
reviewed what was on the books at that time. To the extent there\'s a
change and there\'s another review, there\'s another look and it seems
to me that that kind of a change would be quite dramatic and FSIS would
deal with it and make a decision.

The decision FSIS would eventually make, I think, is that if FDA had
said from a food safety perspective there\'s no issue, FSIS wouldn\'t
have an issue with it. If the decision hadn\'t been made then you would
think under this regulation that would be sound and FSIS would take an
individual look, but it\'s not really designed to, you know, approve a
generic \-- a practice which has become general.

MS. SULTON: Michael.

DR. SCHECHTMAN: My question is actually on different things. I think, if
I can just add, and Larisa you can add, I think it\'s a general practice
though that FSIS consult with FDA, you know, if they know that this is a
genetically engineered animal they will confirm with FDA and I mean FDA
has the authority on the safety, the animal itself, of the food derived
from the animal itself.

So, typically FSIS defers.

MS. BRYSON: Yeah, and I would say \--

MS. TUCKER-FOREMAN: That\'s very qualified. They don\'t have to defer to
FDA about whether or not the amount of bacterial contamination in a food
product is safe. It\'s all the specific items that are covered by the
Food Drug and Cosmetic Act.

MS. SULTON: Larisa, did you want to speak?

DR. RUDENKO: Yeah. I was wondering if somebody could, and Nancy, if you
wanted to speculate on how it could be formally adopted, CODEX
guidelines for the evaluation of food safety in the genetically
engineered area would apply?

MS. BRYSON: I really couldn\'t speculate on that. But I would say that,
in general, and you can see this and understand why I spoke about OIE,
we like the idea of international trading partners.

MS. TUCKER-FOREMAN: I\'m not entirely for that degree of depth right
now. FDA has proposed to eliminate the zero tolerance for *Listeria
monocytogenes* in frozen desserts and adopted by Codex, and FSIS has
vigorously objected to that change.

MS. SULTON: We have a number of cards up. Does anyone have something
further on this point before we go to the next question? Guy?

DR. CARDINEAU: Well, I had a follow-up view to Alison\'s question about
experimental animals. As an experimental scientist, at what point are
you past experimental? So, if you\'re taking a transgenic animal are the
progeny of that animal considered experimental or are the progeny of
those progenies experimental? Because that really makes a big difference
in the definition.

The original animal would be an experiment, but when they have progeny
those animals are no longer experimental, they\'re progenies. So, that
would step outside of the boundary of this regulation.

MS. BRYSON: That\'s an excellent question, but I think you need somebody
from the government to answer it.

DR. CARDINEAU: This falls in line also with Larisa\'s comment about the
CODEX rules I think too because, you know, where is that bright line?
Maybe there should be.

MS. TUCKER-FOREMAN: Yes, but there\'s nothing right now.

MS. SULTON: Mardi, you\'ve been very patient and then Alison.

DR. MELLON: I just wanted to note \-- you know, I don\'t want to go any
further with it, but just to note that in thinking about the
export/import context that a product could refer to live animals coming
in. It could refer to the leg of lamb, you know, being frozen and coming
in. It can also apply to sperm, to, you know, to semen, to eggs, to
embryos.

So, all of these are animal products that are treated that would, you
know, could or could not fall within the statutes that we\'re talking
about.

MS. BRYSON: You know, with respect to that there\'s a statute which
regulates those animal products.

DR. VAN EENENNAAM: I\'d just like to follow up on your comment about
forthcoming regulations. Is there something specific that you were
getting at there that would enhance the discussion we\'re having?

DR. RUDENKO: The current CODEX guidelines about the definition of food
safety from RDA animals are sort of in the final stages of approval from
the CODEX Secretariat. We expect those sometime at the end of June, July
that should be in the process. I\'m directing the issues of standards
and although I\'m not sure that CODEX has a legal standard such as, you
know, no significant risk or they\'re called risk safety assessments,
and basically what they are methods by which one would evaluate the food
safety of a particular genetically engineered animal.

And they\'re written at a fairly high altitude, but they do not address
the issue of experimental or investigational animals.

DR. VAN EENENNAAM: So the concept then would be if one country did that
kind of an assessment it would be acceptable to export it to another
country?

DR. RUDENKO: I don\'t believe it talks about export. I think it talks
about harmonized ways or valid ways.

DR. SCHECHTMAN: I would like to respond to the very last bit there. The
whole issue of mutual acceptance or harmonization or mutual acceptance
of reviews, mutual acceptance of evidence, all of those things, that\'s
a very, very much more complicated and lengthy process that\'s well
beyond coming up with agreement between countries that there are common
principles that they use for their reviews, to the extent that those
things have been adopted at various levels over years of negotiation
before they get there.

DR. RUDENKO: And I\'m saying in general to the extent that there are
sanitary and phytosanitary standards for the U.S. and have to be adopted
through regulatory methods.

MS. SULTON: Carol.

MS. TUCKER-FOREMAN: And their approval have been in the past the subject
of issues before the International Trade Board in which when thought to
be in violation of that the countries have chosen to pay whatever fine
was loosely determined or defined and assessed by a court rather than
change their policy.

The European Union still will not import U.S. beef and poultry and
previously meat that has been treated with hormones despite the fact
that the International Trade has found that it\'s inconsistent with the
trade agreement.

MS. SULTON: If there are no further questions of Nancy if you want to
thank her for her presentation. We\'ll return to our discussion of the
outline.

MS. DILLEY: Sure. We have opportunity for some discussion before we have
another presentation at 11:30. 11:30 is when we have it scheduled.

When I was looking at considering Nancy\'s overview of authorities and
she\'s broken it out into safety approved products from animals and
animal health and safeguarding authorities, and determination of animal
disease and animal welfare, just an outline of her paper and her
presentation, marketing, labeling, and process verification authority,
and then research.

I was looking at the outline on page 2 at the top where it says some
exploration and discussion of those topics about which USDA had core
competencies such as... and you see most of what is covered is about the
animal welfare, animal disease, information and education, agricultural
markets, and then other category.

And I think the way we had approached that in terms of our overview or
introduction was to talk about, again, because the challenge that we are
in in terms of our contextual portion of our discussion which is a lot
of these decisions in terms of who is doing what is still under
discussion.

It\'s not in the public venue and yet we\'re talking about, we are a
USDA advisory committee and trying to sort through the "what might be
relevant for USDA authorities" given that\'s the body we\'re trying to
\-- the agency we\'re trying to serve.

And, so, I don\'t \-- one question for me is, and for the committee, I
think, is having a broad brush overview of what USDA\'s statutory
authority is in the various areas, is there more that we want to talk
about or frame in the context of transgenic animals and that there may
be some relevance in terms of the authority because you talk about the
relevance of the authorities broadly speaking in terms of animals.

But whether transgenic animals add any additional consideration to that
or if that\'s something the committee wants to go into is kind of a
question to you in terms of is there more than just understanding its
derived authorities, and its competencies that we want to explore or is
the next portion of the committee\'s deliberations to look at elements
of a road map and look at more specifically the next section under
topics, number 2, and break that down into particular areas and
different thoughts about what relevance or questions arise given
transgenic animals, genetically engineered animals.

So, those are some of the questions I think in terms of looking at what
does this mean, what does that context mean for our deliberations, and
where you want to go with that? Questions have been raised in terms of
imports, et cetera, but are there other questions in terms of trying to
provide or capture our outline for further deliberation by the
committee?

DR. LAYTON: Can I ask? I want to go back to animal. We just heard from
Nancy. Animal welfare is only covering experimental animals, research
animals. So, \--

MS. DILLEY: The display, whatever, I don\'t remember the slide. It\'s
more than just research.

DR. LAYTON: Is it appropriate under core competencies, item number 5, or
is it more under the research area which I\'m trying to remember where
we got that.

MS. DILLEY: Carol?

MS. TUCKER-FOREMAN: I was going to ask Nancy. Experimental animals, the
point at which you\'re experimenting with the transgenic animal, would
it fall under the Animal Welfare provisions?

MS. BRYSON: Um \--

DR. CARDINEAU: You\'d have to get approval at a university.

DR. VAN EENENNAAM: The Animal Welfare Act, at the back of that there is
a discussion about how it is \--

MS. DILLEY: Greg.

MR. JAFFE: Yeah. And, again, this goes back to my idea that we
shouldn\'t be looking at definitions and statutes as much as issues and
areas. And, so, yes, I may have heard about the Animal Welfare Act, but
clearly USDA does lots of things that relate to animal welfare. When
they slaughter animals at slaughterhouses they have all kinds of humane
procedures and things like that that fall under animal welfare or animal
health issues.

FDA looks at cloning and spend a huge amount of their risk assessment on
animal welfare issues kinds of things, so, to me, we\'re not \-- when we
finish this outline, when we want to talk about animal welfare I don\'t
think we should be talking about animal welfare as defined under the
Animal Welfare Act.

It\'s solely to research animals that are non \-- but we should be
talking \-- I think when we\'re talking about transgenic animals and
genetically engineered animals I think one of the topics that would be
at issue, if those products come in for commercialization; animal
welfare issues associated around using that technology and how that
impacts the animals.

And that\'s an issue the public is going to be aware of and it\'s
something that I think the government needs to be interacting relating
to. I don\'t think it\'s necessary to fall under the Animal Welfare Act.
I\'m not sure where it\'s going to fall under, but I think to sort of
ignore that topic and look at it from the Animal Welfare Act
irrespective, misses what I think are premises under this paper and
under our discussions.

DR. LAYTON: That\'s what I wanted to clarify, Greg, so we\'re all on the
same page on that. But that\'s what we\'re talking about, not animal
welfare kind of stuff so we were really talking about a broader scope of
things. But what\'s in this outline is the broader things, not just the
experimental.

MS. DILLEY: Mardi.

DR. MELLON: Well, I think we need to back up in terms of the context for
this paper. The context of this paper is that the determination made in
the mid 80\'s about a federal government that it was not going to seek
new regulatory authority to regulate genetically engineered products and
that instead it was going to seek to use all of the authorities already
on the books to, you know, depending on your point of view, apply them,
or, twist them if necessary to do what needed to be done, but that all
of the discussions that were had by the federal government among itself,
by the agencies of the federal government among themselves, was
basically how to use what you\'ve got.

And that sets up a fundamental tension when you\'ve got a new technology
that raises a new set of issues and you\'re asking an existing
regulatory framework to address it, I mean, it may work but it may not
and, of course, other countries have taken a different approach to the
regulation of genetically engineered plants and animals. They don\'t try
to twist the existing statutes. They often pass new special legislation.

But I think we need to keep that as kind of, or state that explicitly,
that that\'s the kind of \-- that\'s the mind set within which a lot of
these discussions take place because it leads to \-- you know \-- I look
at something like talking about USDA having core competency such as
animal welfare. I don\'t see that they have a core competency to look at
the animal welfare of food animals going for food. They\'re completely
outside of that area.

They have no authority to do it even if they wanted to do it and they
don\'t do it. So, you know, it\'s kind of a different \-- it\'s not
necessarily an issue that we want to address but we need to keep in mind
that we\'re dealing with an existing framework that, you know, may or
may not be adequate to the task we\'re studying.

And as a matter of policy we\'re kind of going to err on the side of
trying to make what we have work rather than looking for places where
new authority might solve the problem.

MS. DILLEY: Carol?

MS. TUCKER-FOREMAN: I wanted to ask Greg if that\'s how he sees his
proposed approach to this. And if you\'re talking about what\'s
necessary to have an adequate structure for regulating these products it
might improve the use of the law and we don\'t have to recommend it but
we might conceivably say there\'s no place where this is going to go
from. Is that right?

MR. JAFFE: Yeah. I mean, I think it seems to me the issue is I think
where we can be of most benefit to USDA, the government sort of thing,
will be hearing the new area of research, a new area of application, of
technology that may require coming along the pipeline.

They may or may not be commercialized but if they do get commercialized
and do get out there what are the \-- you know \-- what is the
government\'s role in that process? What are the issues that the
government should be aware of because the public or there at the
industry level are going to have concerns about things? What are the
safety issues, what are the marketing issues, what are the ethical
issues and things like that?

And for some of those, you know, where should the government be
interjecting itself in that process? We know for any type of product
that goes to market today the government gets involved in different
places and may or may not the federal government may or may not get
involved and State government may or may not be involved kind of thing
with this new area. Where should the government \-- what are the
significant issues that should be in the government\'s mind if these
products come to market and where should they get involved?

Yes, I can see clearly some of them. I mean, the ethical issue in
particular is one that clearly may be different here than in other kinds
of products that have come to market and they require legislation and
they may not. There may or may not have something there.

MS. TUCKER-FOREMAN: So it wouldn\'t necessarily have to write in the end
such a change. We could simply say there are areas that currently are
covered.

MR. JAFFE: Well, I\'m not even sure we should go there and sort of say
which areas are covered or not covered. I think we can impart the idea
that these are issues or areas that are going to be on people\'s minds
either from a producer point of view, from a groceryman\'s perspective
point of view, from a consumer\'s point of view. As the products come to
market people are going to want some opining on, some involvement on.

I don\'t think we should get to the point of saying and USDA, FDA,
whoever can do it under this statute, but I think when you start getting
into that amount of detail I think we get into legal discussions that we
don\'t necessarily have the competency for and the government is going
to make their own determination on that anyway.

I\'m not sure we add a lot by saying we think it should be under this
statute. They may have a different view of that. I think it\'s better to
say this is an area that needs to be covered somewhere in the government
if you want these products to have any \-- you know \-- if people are
going to be able to assess them and decide whether they want them.

MS. TUCKER-FOREMAN: How do you then deal with the notion of dividing the
core competency? It\'s something where there is no competency right now.

MR. JAFFE: Clearly, we can identify certain things and say we think this
is not in the competency of USDA. We clearly could go towards some level
of that. I don\'t have a problem in doing that. I just think going down
to the level of you should do it under this statute and this regulation
I think is getting too down. As we know, the government makes its own
determination about which statutes they\'re going to deal with and I
think we can obviously have an opinion on that but I think they\'re not
going to take our opinion on that.

The lawyers, General Counsel for USDA, FDA, and others are going to make
their own assessment and independently derive, but I don\'t think that
adding that and spending a lot of time on that in my experience with
working with the government and watching over it will have an impact of
what I said.

What we can say is food safety, ethical issues, whatever it is, is a
real area that the government needs to be involved in in order to
safeguard the environment, or, in order to make consumers comfortable
with it, in order to allow grocery stores that want to put this item, we
could say, we could talk about it from our different stakeholder
perspectives and why the government is getting involved in an issue is
important without sort of saying this is specific and they should do it
under this specific statute.

We can say and in particular we think the issues 1, 7, 9 and 10 are
things that USDA historically has had knowledge, it has expertise in,
and they might the ones to do it and we could say 2, 4, and 7 are ones
that they typically don\'t and we don\'t think that historically
they\'ve had a lot of involvement and this would be out of what they\'ve
done in the past.

I think we could clearly add some of that, again, without going down to
the specific regulation or law, but that\'s just my sort of thoughts.
Nancy may have other views.

MS. DILLEY: Let\'s go to Daryl first and then Nancy.

DR. BUSS: Well, I guess I would agree with Greg\'s comments and also
just looking at the outline. It seems to me that the value of the
document we\'re going to prepare really lies in making comments such as
regulatory. For example, if that\'s what we\'re talking about logically
follows from that as opposed to earlier on.

MS. DILLEY: Right. I mean, that was the general sense of the discussion
last meeting as well as some of the discussion with the working group
and the question is then we\'re trying to put it through the value added
given all these other contextual pieces that Greg\'s already elaborated
on and others as well in terms of our time as well as what we can add to
this discussion in the appropriated time we have to deliberate on it.

Nancy?

MS. BRYSON: I\'d like to follow up on Greg\'s comments to say that
issues emerge like, what are the animal welfare considerations of
animals who have those particular purposes? Better decisions can be made
when there\'s some research to build decisions to be made on. Maybe, you
know, identifying some of these issues as important ones to get some
information out of would be very valuable because USDA may not have a
core competency in that, but they certainly have access to people who
really do understand how it fits so maybe they could provide an
important function.

MS. DILLEY: Well, that makes sense to me. I mean, to me, kind of the
logic flows in terms of our deliberations and following with what you
all have said is looking at the issues under elements of a road map is
what we have it under now and maybe it\'s covered under transgenic
animals and similar to what Greg was saying, it\'s kind of big
categories of things that really need to be thought through in terms of
potential government involvement or oversight and, you know, what they
are category-wise and then why we think that and you get into animal
health and welfare, et cetera and kind of figure out how could the USDA
potentially play a role in that or what else under the issues and have
that conversation.

We might want to go back then and talk about the core competency pieces
Greg alluded to depending on our time, et cetera saying historically
USDA has had these four competencies and it may be that these areas, I
don\'t know, x, y, z, or, a, b, c, d, e, f, g are areas that they may
delve more into but I think to me the conclusion of we\'re not \--
we\'re still on the same wavelength of we\'re not going to get down in
the weeds and say, well, USDA should be regulating x, y, and z.

These issues of animal welfare, either under the Animal Welfare Act or
whatever, we\'re not doing the legal analysis. That\'s not what the role
of the committee or what we can provide value added, but it\'s more the
scan of what are some of the issues related to governance of transgenic
animals that we really think are important.

And, you guys continue to figure out how we\'re going to do that without
a legal discussion, but we really think you need to do this. These
issues are really important to pay attention to and they have some role
in government oversight or government piece that\'s relevant to
transgenic animals.

So, we just want to get the flavor and if that makes sense to people in
terms of the logic flow and how we would have that discussion, these are
the elements of the roadmap or what we would spend more time on going
through and trying to characterize in terms of different perspectives of
the committee and then depending on time we can come back and deal with
the historical competency pieces of USDA and whatever more we want to
say about that having had the other discussions in terms of elements of
a road map.

Carol?

MS. TUCKER-FOREMAN: You just said, you used the phrase that I would
strongly prefer to use rather than the notion of a clear roadmap. What
are the key issues of government regarding transgenic development and
marketing of transgenics?

DR. LAYTON: Government or governance of transgenic animals?

MS. DILLEY: Engineered or whatever terminology you wanted to use.

MS. TUCKER-FOREMAN: The need for a clear roadmap in the
commercialization of transgenic animals is not an emphasis that I\'m
comfortable with. The issues are the government\'s.

DR. SCHECHTMAN: Can I ask about a hybrid of the two to see if they \--

MS. TUCKER-FOREMAN: I objected to it when it was put into the pure
document and I still object to it.

DR. SCHECHTMAN: Let me just answer the question if I may. Is there need
for a clear resolution of the issues of governance? Is that acceptable?

MS. TUCKER-FOREMAN: That\'s okay.

DR. SCHECHTMAN: That\'s what I wanted to know.

MS. TUCKER-FOREMAN: What I object to is the presumption that we have an
obligation to commercialize transgenic animals. That\'s not determined
yet and until that\'s determined this is an issue that \-- you\'re
wording is fine. As the roadmap says we\'re going to go from A to B and
there are other determinations that have to be made, all those listed
here, before we know that.

MS. DILLEY: So, the key pieces are the governance and then the clarity
around that subject. Okay. Nancy.

MS. BRYSON: I\'d like to get into this governance as well because the
roadmap is a little bit inconsistent with the fact that we\'re saying
that we\'re not going to \-- that all of this is being conducted at the
same time that the issue about regulations are being discussed across
the government and so there\'s a little bit of inconsistency and we
might be more helpful to talk about governance.

MS. DILLEY: Issues of governance, does that make sense to people?

DR. LAYTON: Roadmaps also tend to have signs so you know exactly what
you\'re doing. Rules would tend to be better.

MS. BRYSON: There\'s more flexibility.

MS. DILLEY: Any other thoughts on that? I think the next step then, and
I\'m not sure to bring those items into the conversation now as opposed
to after lunch, but to me, then the goal would be to go back to the
issues of governance. These were taken from our discussion last March
and then we reviewed those and made sure that we got the list we want
and those kinds of pieces and actually start into some of that
discussion.

And we have more information based on the publications we have, both one
today and one tomorrow.

DR. LAYTON: Can I ask a couple of questions?

MS. DILLEY: Yes.

DR. LAYTON: Looking at the outline, you know, a couple of paragraphs
states, couple of paragraphs, but I\'m not sure that we finalized the
animal thing.

MS. DILLEY: The animal thing?

DR. LAYTON: Yeah. Before her presentation which she tried to answer.
What if we said potentially transgenic which I\'m assuming means
genetically engineered animals, food animals genetically engineered for
food and non-food uses. So, animals, anything but humans. Are you really
talking livestock, are we not talking livestock? I\'d really love to
make sure I know what that wasn\'t scoping.

Did we decide that? And then I think that what I\'m seeing, is the issue
topics relevant? Is that a paragraph no more, sort of? And so number 5
is also sort of a consensus that\'s a fairly small piece of this is what
we\'re going to talk about or this is what was documented about. Right?

MS. DILLEY: Right.

DR. LAYTON: So, it\'s okay, the paragraph of what we\'re talking about,
but did we finally decide that is it livestock genetically engineered
for food and non-food uses, USDA\'s terminology or is it really animals?

MS. DILLEY: I don\'t know if the equivalent terminology is between food
animals and livestock. I don\'t know whether food animals are not
livestock.

DR. LAYTON: Poultry?

MS. DILLEY: Poultry are not livestock.

DR. LAYTON: So we need to define food animals as livestock and poultry?

MR. JAFFE: Or raised for food.

MS. DILLEY: Raised for food.

DR. LAYTON: Raised for food.

MR. JAFFE: Livestock is defined as raised for food.

DR. LAYTON: So we are excluding other four legged animals that are
livestock that are not raised for food?

UNIDENTIFIED MALE: Anything but a human is an animal, isn\'t it?

DR. LAYTON: But food animals because food animals limit the live horses
\-- I mean no horses. Horses aren\'t food animals so we\'re not going to
talk about horses. We\'re going to talk about food animals.

MS. TUCKER-FOREMAN: Including fish.

DR. LAYTON: But those aren\'t food animals. Those are farm raised if
they\'re raised for food, humanly raised for food, not wild food, not
wild.

DR. CARDINEAU: They\'re not warm-blooded so that would be \-- my reading
it would be the only way they could fall under the meaning farm animals
because their definition requires warm blooded. Farm animals allows you
to bring in farm raised fish I think.

DR. LAYTON: But food animals \-- I want to get this definition down on
paper \-- food animals are animals raised for food and non-food uses. I
just want to clearly say that food animals are those animals raised for
food.

DR. MELLON: And we\'re going to consider the food and non-food use of
those animals.

DR. LAYTON: The food animals are those raised for food and we\'re going
to consider both food and non-food use, transgenic.

MR. JAFFE: The animals are raised for food.

DR. MELLON: No, because that distinguishes the animals that are
harvested from the wild. They\'re used for food but not raised for food.

DR. LAYTON: But not raised for food.

DR. MELLON: So if somebody goes out and kills a raccoon and brings it
home and skins it, that is not a food animal under our definition.

MS. TUCKER-FOREMAN: How about genetically engineered?

DR. MELLON: At least it\'s not a potential and a whole bunch of \--

DR. LAYTON: Well, it is the Glowfish®. I mean, we\'re not going to talk
about Glowfish® in other words.

MR. JAFFE: I mean, we eat the Glowfish®.

DR. LAYTON: You could.

MS. BRYSON: Livestock is grown into food animals. Livestock is all farm
raised animals. Why are we restricting food animals? I\'m just asking.

DR. LAYTON: I want to know. Because we wrote food animals in this
document.

MR. ENGLER: Not all animals raised for food are livestock.

UNIDENTIFIED MALE: Yeah. Poultry is not livestock.

DR. LAYTON: I just want to make sure we had a definition.

MS. DILLEY: Jamie, did you have a comment?

DR. JONKER: Yeah. I think we probably got a number of terms that we need
defined and maybe we can get a small group over lunch to do something on
that so we can discuss it afterwards. It\'s easier to react to something
than to try to \--

DR. CARDINEAU: Would snails be included?

DR. MELLON: They\'re included in all definitions. We don\'t care whether
they\'re included in any USDA regulations. This is going to define the
scope for ourselves.

DR. LAYTON: But we need a list of definitions and I just wanted to make
sure.

DR. MELLON: I agree.

DR. LAYTON: I was hearing different things and I wanted to make sure.

MS. DILLEY: Okay. Pat, you were kind of wanting to clarify just the
introduction piece.

DR. LAYTON: The introduction piece, what we\'re going to talk about,
what we\'re not going to talk about. And then we get to topics that
really is the body of the report. Is it mostly this topic issue?

MS. DILLEY: And governance in transgenic animals and put some clarity
around that governance.

DR. LAYTON: Clarification is the key issue for governance.

DR. SCHECHTMAN: A clear resolution.

DR. LAYTON: A resolution.

MS. DILLEY: All right.

DR. SCHECHTMAN: We have a moment due to difficulties as we\'re
translating the Power Point presentation from one newer version of Power
Point to the one that\'s on this machine. So, why don\'t we take five
minutes break while we do this.

(Whereupon, a brief recess was taken)

DR. SCHECHTMAN: I am now pleased to welcome Dr. Craig Morris, the Deputy
Administrator for Livestock and Feed Programs in the Agricultural
Marketing Service. And he is going to speak to the committee on
traceability and voluntary audit-based programs in AMS. Dr. Morris,
thank you for coming on fairly short notice. Sorry for the technical
glitch and we\'re happy to hear what you have to say.

DR. MORRIS: At the Agricultural Marketing Service we provide a number of
voluntary marketing services dealing with marketing issues primarily.
They range anything from sort of having a meat program to export
verification programs. I\'ll walk you through some of those. We also
oversee a number of regulatory issues such as labeling right now,
marketing news reporting programs, market orders, research and
promotional programs and a variety of other things.

What I\'m going to focus on today is a request to talk about
traceability of transgenic or cloned livestock for some of the services
that we provide that are potentially play a role in marketing niches.
Again, the angle that we take on these is not one of a regulator. We
aren\'t saying that a product is safe or unsafe, whether it is
appropriate for human consumption or not. Simply what we\'re trying to
do is act as a third party in assuring a buyer and seller that the
seller\'s product is what they purport it to be or that if you\'re a
buyer, if you have specific desires for the way the product is produced
or an objective quality other than itself we can help fill that niche.

So, if you look at even the origins of our agency, these grades, for
example, date to the 1920\'s. That was an example where purchasers,
which were the officers of shipping lines, were having trouble getting a
consistent quality of beef from the major packers in the United States
at the time.

So, it was asked of the Department of Agriculture to provide a voluntary
service really on behalf of the shipping lines that were out at sea.
Because USDA could have employees in the packing plants, the shipping
lines could be sure that they received that consistent quality from the
source.

And, so, federal employees went into that activity. Again, these are
voluntary services. They\'re either asked for by the buyer or seller or
both and are actually carried out for a fee, a full cost recovery. So,
to build on that, again, ours is a verification program which are what
we believe is the next generation of grading.

Initially all of our grading services were conducted by our resident
graders. These are federal employees who were actually stationed in the
plant and that was very applicable to a service where you\'re looking at
something that you could certify about the process itself or the cut
properly when we use the term certifiable we\'re talking about
processing plant purchases; is the strip steak correct? Is it one inch
tails on both ends? Is it trimmed to a quarter inch fat? Those sort of
things you could objectively determine on the product.

As we get into more things that deal with production of the product
those are things that once you get the product you really can\'t expect
out of it what the customer is expecting from it and so if you look at
some of our next generation of services that we provide, the National
Organic Program for example, a lot of other services relate more to how
is the animal or is the commodity produced and another example is that
of a company to have a resident grader at a packing plant could know if
the animal is bad.

You can\'t simply touch that out, especially when you start getting into
certain claims that we get into what I believe you talked about a little
bit in Nancy Bryson\'s presentation. Some things like grass-fed.
There\'s really nothing you could look at on a piece of meat to
determine whether or not the animal was fed a specific diet. In those
cases what we do is we require the supply chain to document the quality
in its systems and we comment and then audit periodically.

Again, these services are user fee funded. There are no appropriated
items set aside for this purpose. And their markets are open. They allow
the companies to make the claim for targeting their product. So, really,
whatever the marketing niche demands there is a premium for that product
and your standard. That\'s how you overcome the cost of bringing us in.

Let me say as we walk through this, these slides are pretty much 50,000
foot. We\'ll have some examples of some our current services that I
thought might be relevant here so feel free to ask any questions. I
think I don\'t know enough about where you all are going to know fully
who all of your customers are so please interrupt me at any point. And,
finally, they\'re not intended to replace the regulations.

Again, we provide services related to a lot of buyer desires or seller
desires. They\'re never intended to pay the U.S. Government. We will
fulfill niches that certain people think the product means a certain
thing to them. We often refer to that as regulating product. It\'s not
saying that the government itself felt that the product is safe or
unsafe or appropriate or anything like that. Just differentiating that
product in the marketplace and traditionally there\'s a reaction to
that. Our market user reports as those market niches become available,
we\'re going to make a beef program, for example, where we actually have
a return on investment for the producer, we\'ve drawn up a user plan
system and then began reporting that product simply distinct from itself
because it\'s a demanded premium.

Again, that\'s all market systems are on a level playing field. If you
know, a producer may, if I choose to get engaged in the business of,
let\'s say, grassing my beef, what kind of premiums can I get for that,
or, natural raising, if I\'m not going to treat my animals with
antibiotics, I\'m not going to treat them with growth hormones, I\'m not
going to feed them things like a protein, what kind of premium could I
get for that?

There\'s a cost associated with that mass production. So, it helps you.
It\'s also a cost not just in the method of production, it is
segregating and that\'s really one of the big things for agriculture is
that cost associated with keeping commodities distinct and separate from
the commodity itself and that in itself has huge costs and one has to be
overcome with a premium on the buyer.

A couple of examples of programs that I thought I would mention are
programs that are up and running is our process verified program. That
is certainly our gold standard program. This is the government\'s
version of fully ISO 9001 compliance system. This is a company that has
chosen to take on the responsibility of fully documenting their process,
all of their management commitments, they\'re employee trained,
everything, and then they subject themselves to document reviews by
USDA.

We have a team of auditor-qualified employees on our staff that review
the documents. We then do pre-award audits and an audit comes after that
annually. We actually go out and make sure that the process that
they\'re following, and, again, I\'m not saying the product necessarily
is any better or worse, it\'s just it\'s produced under a consistent
process and you\'d take the company\'s word for that and you take
USDA\'s word for that. Such process-verified products actually all carry
an official mark that looks like a grade shield that has "USDA process
verified." You see that in marketplaces in writing. They\'ve chosen to
undertake this path. A level of the rollout would be our Quality System
Assessment Program, or QSA. You hear about that a lot in the community.
This gets into things like storage verification, age verification, those
sorts of issues that relate to certain markets around.

For example, U.S. beef is only eligible for export to Japan that are 20
months or younger. That kind of a program is carried out through our QSA
program where producers are actually able to verify to the packer
through the supply chain the actual chronological age of those animals.

Export verification programs. Again, you have a little bit of an overlap
there. Initially after the finding of the first case of mad cow disease
in the United States, the United States virtually overnight lost all of
our export markets for U.S. beef. We reopened those markets in
partnership with APHIS, the Food Safety Inspection Service, as well as
the Foreign Ag Service with the use of what are called the Export
Verification Program.

What we do though is follow the carcasses and in this case it\'s born in
country requirement. For U.S. livestock to be eligible for their meat to
be exported to those markets, has to be produced a certain way. The
export verification program actually assures the products that are being
shipped overseas meet the requirements of the foreign buyers and that
are above and beyond minimum inspection requirements in the United
States.

So, we have a number of these programs in virtually all of the markets
in the United States export to, to ensure that those additional
requirements of foreign countries are met. Historically, the Korean
market which has just \-- which has opened up or will be open, it would
take only boneless products for example. So, we worked with packers to
ensure that the products that were being shipped from the United States
to Korea were boneless products. That was a 30-month market as well and
in that case it was assurance that the beef that was coming from 30
month age cattle. Japan, as we talked about is all products, but it has
to be product from animals that were 20 months or younger.

All of these export verification programs are carried out by the
companies themselves establishing their document quality management
systems. A level below that is is the Process Verified Program. It meant
subjecting themselves to the, in this case it\'s a twice per year audit.
They actually take on the responsibility of more frequent audits because
the system is a little less comprehensive than these.

And the other one is our Non-Hormone Treated Cattle Program. That you
could actually say was our first export verification program. We\'ve had
a longstanding trade dispute with the European Union relative to the use
of growth promotants in the United States to allow U.S. beef entry into
the European Union. That beef has to come from cattle that were not
treated with growth hormones. It also gets into a couple of other
requirements for export under the quotas of the EU related to high
quality which relates to how the animals were fed. They have to be fed a
high energy diet, grain diet for at least 100 days of age, or grade
choice or higher under a grading system.

The Non-Hormone Treated Cattle Program is a partnership between the
livestock producers and packers to ensure that all the requirements of
the European Union are met. So, that\'s a program that we\'ve had going
on for some time, even pre-dated BSE. It had absolutely nothing to do
with BSE.

And in pork for the EU it relates to the use of another growth hormone
that\'s used in the United States and not approved in the European Union
which is Ractopamine, Paylean®, which is a commodity product for this
product. This program for pork review ensures that pork products that
are being shipped to the European Union are not hogs treated with
Paylean®.

Now, if we were to look at the examples I gave you and break them out,
we have these prescriptive programs which are really customer-driven,
objective requirements that they want met. The animals for that
obviously would be Non-Hormone Treated Cattle Program and Pork to the
European Union Program or even that broader class of that Pork
Verification Program. This is very prescriptive because the United
States in partnership with USTR and FAS who negotiated those programs
with that foreign market, so, that is their program.

We\'re simply in the form of its agent here in the United States. Our
Quality Standard Programs are the more generic ones I started with,
which are the process verified or generically a quality system program.
Those are the ones that are given to any market participant to say I
have a \-- I produce a certain way. I want USDA to assure my customer
base that it\'s consistently produced in that manner.

Now, how they promote that product is either "USDA process verified" or
"audited by USDA." Now, the role of USDA, all these activities that we
carry out are authorized under what\'s called the Animal Marketing Act
of 1946 which is a very broad piece of legislation that provides for us
to provide for these sorts of services and Nancy talked to you a little
bit about the authorities that that provides us. Again, very broad base
in order to carry it out.

We interpret it to allow us to provide the audit verified to improve the
company\'s production practices. Again, we see it as our role to
facilitate marketing and the overall charge being under the Act of \'46.
And in that relationship, obviously, we always act as an independent
third party. We aren\'t trying to get into the role of a good standard,
a bad standard those sorts of things, but more don\'t take their word
it. That product meets your requirement, take our word for it.

Participant requirements. Companies must implement quality management
systems, document the company\'s production practices for meeting
marketing claims and must satisfy the requirements. Most of the
responsibility is carried out by the person who is actually requesting
the service and who is paying for it. They\'re taking on that
responsibility and opening their books up to us to ensure through our
auditing these products are actually being produced consistently through
that process that we approved.

Snapshot of our Process Verified Program which, again, which we would
refer to as top tier and I should have put up a photo here as it is
actually used in commerce. But it\'s an evaluation of the entire
production process, management fully trained, everything that you would
find in the ISO 9000 standards. We actually sit on TC176 which is the
Partnership Technical Committee for the ISO 9000 standards.

We participate in that with a lot of other service providers out there,
whether they be ANSI where we\'re on the ANAB, American National
Accreditation Board, or with BSI, a lot of the other service providers
so we actually act as somewhat of a registrar on that. Products are
tested in accordance with performance standards and traced back to OIE.
We get into a lot of verification of federally processed verified
companies.

The IMI Global which you might be familiar with. We work with them
ensuring that the traceability systems that are in fact verifiable and
reliable. Both the finish of the product we verify information that is
transferred throughout the process of the production chain for them to
be able to use that mark against all the ISO 9000 standards.

Again, the animal trace back and identification verification systems
will be instituted as required by Ag Services as a checkpoint. We
transfer information to your supply chain as well as the critical
control points for all that\'s being identified and ensure we\'re not
been violated. We have a number of other marketing claims. They\'re
based on industry demand and we\'ve talked about grass-fed livestock
and, again, I think there\'s been a lot of discussion in the industry
about the standards being developed.

In general, we get into claims, we try to stay out of the business of
developing standards when we can. It\'s only in the absence of a
standard that we feel necessary to do so. Because we provide independent
third party services we\'re really at the mercy of the company coming to
the door and saying this is the process we want you to verify.

Certain processes are very objective. No antibiotics. No hormones. Those
sorts of things are very \-- there either is or isn\'t. When you start
bringing in a quality of term like grass-fed which means different
things to different people; were naturally-raised means different things
to different people, we try to look for some sort of industry standard
out there. If one doesn\'t exist we find it necessary to try to develop
our own standards not really for serving as the basis of commerce out
there as much as the minimum level that we would choose to associate
ourselves with.

Again, the Agricultural Marketing Act of \'46 really tells us to
facilitate marketing and we never want to be a participant in the
marketing discussion. And if we were to process verify and would provide
services to a company that we felt was marketing their product which
actually raised the grass-fed and that if we really don\'t feel that the
majority of market systems understand or that is the standard, we will
choose not to associate ourselves with that particular claim or that
particular firm until they meet the standards.

Normally we\'ll look for things like standards of identity or things
like that like the sister program associated with the Food Safety
Inspection Service. But if those don\'t exist then that puts us into
this role. Never Ever 3, for example, was basically our response to the
naturally-raised issue.

Naturally-raised is a claim that\'s out there in the marketplace.
Natural is a claim that\'s out there in the marketplace. A lot of
natural claims, which are covered by the standard of identity,
maintained by the Food Safety Inspection Service, really relates to
processing of the meat. It has nothing to do with the destruction of the
animal.

We saw a lot of examples of products actually carrying claims with them
relating to how their animals were raised. Those claims were coming to
us for addressing process verification and we worked with our other
marketing services and we had a dilemma on our hands at what level would
we choose to associate ourselves with this program.

We started down the path of trying to define naturally-raised and found
that it was very challenging quite frankly and so, just so we could open
the door to providing those kinds of services, we just unilaterally
launched a Never Ever 3 program which, again, takes it from a subjective
term to an objective term. Never Ever 3 is exactly what it says. It\'s
no antibiotics, no growth hormones, no genetic program. Yes?

DR. MELLON: Does the never ever claim, is that based on user fees? Do
people have to pay you in order to use that claim?

DR. MORRIS: Yes. Never Ever 3 was really not initially designed to
service a consumer claim, one a consumer would demand. I want Never Ever
3 meat, for example. It was really meant to be sort of like a background
software on a computer that you didn\'t even know was there.

When companies like a Coleman or any of these companies that sell
natural beef came to us and said we want you to verify our natural
program, but our natural program also makes some claims relative to the
way the animals were raised.

What we wanted was the Never Ever Approved Program was the ability for
producers out there, by our producers to approach USDA and say, I want
my cattle to be Never Ever 3 verified so I have the opportunity to sell
to Coleman but I can also sell to Fairbank Beef Natural or any of these
other natural programs out there and I don\'t have to be a part of just
there for watching.

It gives them more market power. Also, on the consumer side, natural
programs that might want to come to us for us to verify that sets for us
a minimum requirement for what we would choose to associate ourselves
with.

DR. MELLON: And that was never proposed?

DR. MORRIS: No. Never Ever 3 was a program that we watched because,
again, it\'s an objective, either is or is not, there\'s no such
activity.

DR. MELLON: But there is. There are a lot of issues about whether it\'s
an antibiotic. For example, I have no idea how you resolve those, but
\--

DR. MORRIS: We followed FSI\'s lead on that related to the \-- you\'re
referring to like ionophores and some sort of \--

DR. MELLON: But they\'re kind of changing their minds. So, that\'s kind
of my question is so where does one go to look to find what the
standards are that back this claim up? I mean, how you define
antibiotics and all of that?

DR. MORRIS: If we\'re associated with the program we would be the source
of that information. If it\'s commercial product it\'s AMS, it\'s not
providing a service to. It\'s a claim which is governed by FSIS\'
labeling protections act. They\'re the regulatory authority to lay the
claims on meat products. We only become involved when someone approaches
us and tries to utilize our independent certified verification of the
claim. Does that make sense?

DR. MELLON: I think I need to \-- I\'ll need to talk more about it.
Thank you.

DR. CARDINEAU: I have a question related to this. I\'m assuming that no
antibiotic is related to growth hormones but what if an animal is
treated for \--

DR. MORRIS: It\'s out of the program.

DR. CARDINEAU: It\'s out of the program. So, if it gets ill and it\'s
treated with antibiotic to cure that disease then it\'s out of the
program.

DR. MORRIS: Right. It\'s out of the program.

MS. BRYSON: Does FSIS automatically accept AMS process verified claims?

DR. MORRIS: Well, that\'s a process verified claim at that point. We may
never approve \-- what happens is companies approach us with a desire to
process verify and these are the claims that they would like to make
associated with \-- in association with what they\'re going to do.
We\'re actually behind the scenes with FSIS on that. So, not by default
but by design. Does that make sense? Just because we would want to
associate ourselves with a company that wants to associate themselves
with us is not is not necessarily ending up with an approved plan. We
would never approve a program unless it\'s already determined throughout
the course of the program if it went to market it would actually be
approved.

So we do that leg work on our own but not too many MOUs or something
like that. It\'s just done. So, if a company came to us that said, I
want to sell Craig Morris\' best beef and we said, okay, this is
something we probably want to associate ourselves with and we didn\'t
want to have a bias and say we\'re not going to approve that claim we
would have to go back to that firm and say, okay, remember that the
facts were approved here, we need to withdraw and resolve those.

So it\'s really a partnership between AMS and the firm and then AMS and
FSIS and sometimes we even get together, the three parties, in one room
to really discuss what can we do, again, because they have the approval
authority on the claim.

MS. SULTON: Jim Robl has a question.

DR. ROBL: Can you tell us the size of these programs, how many animals
are registered within the program?

DR. MORRIS: Well, the Export Verification Program by default ended up
picking up a huge number so we\'re in, you know, eight digits, well into
the eight digit number behind cattle which would be the largest. If you
start getting into source and age verification, which has just become
really the largest two players in that system, you know, we\'re well
over 10 million. That\'s the product that\'s eligible for exports. So,
it\'s one of those \-- it\'s a voluntary service that is really required
to maintain the market share.

If you get into a couple of our other programs that are lower level, you
know, you get the big numbers. If you start getting into pure process
verification most of those are integrated companies with much smaller
scopes. You\'re looking at Premium Standard Farms and more sizes which
are considered larger farms and then obviously with size you\'re looking
at standard global and some of those.

DR. ROBL: And is there an effort to do these kinds of things seriously
as governmental oversight? I guess I look at this and try to wonder why
the U.S. Government is involved in these sorts of oversight issues.

DR. MORRIS: Well, actually the big growth area for us has been
accreditation of certifiers themselves which is really a model that
really started with U.S. exports of organic products to the European
Union. That was really one of the first times that we stepped back as
actual certifiers and instead accredited private certifiers out there
under ISO Guide 65.

What happened was prior to the National Organic Program, we had an
Organic Food Production Act. We didn\'t actually have an operating
national organics program. The U.S. organic certifying agencies, our
agents go all over the country, both public and private and some are
State-led, some are private, were trying to export U.S. organic products
to the European Union.

The European Union actually had an operating community-wide organic
program. Those certifiers needed to be accredited to meet \-- actually
they needed to be accredited as certifiers and be competent to apply the
European national organic standards. So, that was the niche that we were
filling at that point, was to serve as an accreditor using ISO Guide 65
which is really the standard for determining whether a certification
body is competent.

We took that European Union into U.S. development and U.S. Embassy took
that to the European Union saying that USDA Agricultural Marketing
Service is an accredited certification body in the United States,
accrediting roughly 40 certifiers in the US. The Agricultural Marketing
Service actually accredits those farms with a valid certification and
the State entities as well to provide for certification services for the
European Union to recognize their certified products are eligible for
export to the European Union.

We really picked up on a lot of that for verification and A Verification
too and reference to Inot Global, Micro B Technologies (sic). There are
a lot of service providers out there. They\'re really certification
bodies and what we\'re willing to do is accredit them. So, we\'re moving
USDA back a step. We\'ve got a lot of examples of that.

We had an issue when the poultry market was opened up to Russia, for
example. The Russian market required that U.S. ships transporting
chicken to Russia be inspected for their sanitation to make sure the
vessels were absolutely sanitary prior to loading U.S. poultry products
for export to Russia.

Initially that was a service that AMS employees were actually doing at
the ports. We had AMS employees at the ports looking at every ship prior
to loading the U.S. oil primarily. What we did, what we had done as a
subsequent step, is accredit professional marine surveyors on our
behalf.

They\'re like a specific person came here, for example, to one of the
firms and the accreditor actually carried out \-- carried that action
out on behalf of the U.S. government. So, foreign markets, the U.S.
Government involvement has what they want. By the same token the
surveyors who were already at the ports doing a variety of other things
with commerce, are going to provide that service with very little, if
any, additional costs except for the cost for accreditation.

So, yes, there are desires oftentimes by market participants to remove
USDA from the process when we add additional costs. However, for certain
parts of our program you want a USDA processor, a human, for example, or
you want your product to be eligible for export to certain countries,
but you didn\'t want to start with USDA Organics, which is obviously
under the regulatory framework.

There had to be a certain linkage to the government at one point.
Organic is a perfect example. The same staff, like those in my branch,
those are the ones that accredit or certify all the organic certifiers
in the country not only for exports to the EU through the ISO 565
Program, but even to the National Organic Program for domestic commerce.

So, what we\'re doing is now visiting farms, for example for issues, for
issues related to, let\'s say, Aurora there which has had a lot of
issues related to organic. Dairy production in the State of Colorado, we
visited that facility not so much determining whether or not Aurora is
qualified to sell the product as USDA organic but whether or not their
certifier, the State of Colorado. So, we\'re really assessing the
certifier in that case many times.

So, yes, there\'s always interest in that part of the administration.
There\'s always their interest in trying to remove government as much as
possible. Again, we are offering the service voluntarily. In some cases
though it is very difficult to completely remove us from the process
just because of customer expectation.

The Quality System Assessment Program as I said, it is a level below
Process Verified Program. It would not be viewed by anyone as being an
ISO 9000 system wholly compliant but what it\'s meant to do is focus on
very specific, concentrated technical requirements due to the
customer\'s expectation of the product.

We have to have a minimum level of documentation there just because this
is not a grading service. We\'re walking away and having to assume that
when we\'re not there the product is still being produced in accordance
with the customers\' expectations. So, really all of our document
controls there are centered around assuring, in our absence, that things
are being done well and they\'re verifiable.

So, it\'s not meant to catch out the door the one product after an audit
to find out they\'re not complying with policy and actually shipped and
then the penalty, whether it\'s by default or something much more
draconian they lose their ability and have to reapply. And then, again,
because of the liability that\'s carried out and if that number is
consistent they are audited more frequently.

QD programs, which are offshoots, were developed in 2003 which assures
you have continued application. U.S. and Canada has lots of cattle for
slaughter. Importing countries have different identifying requirements,
averaging requirements. Every program is different. Individual premium
countries have different requirements, Korea, Japan, countries all over
the world. It involves mostly packers, fabricators, and processors in
general, except for the age verification which has to do with
non-producers and over 100 program search agents per sheet.

This is a flow chart that kind of gives you an idea of the entire
marketing chain from the calf on the right all the way to export on the
left. That dotted line is really meant to show you where the bulk of our
auditing actually occurs in that program.

That\'s really the slides I had. Again, as this relates to transgenic
and some of the other technologies. We have talked at length with that
industry about the services available and kind of refer ourselves as
much as if this is a market niche to be filled and that\'s really the
capabilities that we have.

DR. LAYTON: Where do those programs interact with the definitions that,
for example, the Federal Trade Commission might use for claims, so, you
know, in the Federal Trade Commission world with those kind of products
do they have to say, for example, recyclable, at the time, and people
had to understand what it was and it had to be generally recyclable in
those communities before you could make that kind of claim. Can you make
claims that people don\'t understand?

You know, Never Ever 3 to most people who wouldn\'t understand what
number 3 is, an offshoot of the research.

DR. MORRIS: Right. And, again the purpose of Never Ever 3 was not to be
a numbered plan. It was to provide producers which were \-- who wanted
to supply a variety of natural programs that already were in existence
the ability for their livestock to be qualified all under different
programs. So, what we can do is tell a producer instead of you paying
for surveys of audits of these commodities this week and then next week
have Coleman Carter audit you and then the next week have Isobar, you
know, one after the other, what we say in a general way and tries to
provide is we will provide you one audit which means that your cattle
meets three things which happen to be components of virtually
everyone\'s natural program.

So, it\'s not so much meant to be a consumer claim. If it was a consumer
claim we would actually have to list out this process, what those three
things are.

DR. LAYTON: And if they were consumer claims then would FTC have
consultation on what the words were?

DR. MORRIS: We would have consultation with FTC. We work with them.
Right now, for example, we\'re working through a regulatory program and
we want very close confirmation from them as we start dealing with rules
of origin and a lot of those things that definitely are in Custom\'s
purview, are in Steve\'s purview, FSIS\' purview. FSIS is technically
not \-- it is, it\'s out of compliance for example with the rules of
origin of COOL, relates to retailers.

The FSIS\' rules of origin really relate to more inspection than origin
of product. The product comes through the USDA federal inspection
facility, is broken open, the strip steak is made into steaks. It will
carry a U.S. mark of inspection from FSIS they do that now because they
do that now because the product has been inspected by the United States
and shipped out to the U.S. consumer carrying a USDA inspection seal.

However, in the COOL, for example, that type of origin which relates
back to the animal, not necessarily where the animal, the meat was cut.
And, so, we have to balance all that with all of our program COOLs as
being one. So, we work with those people and never, ever try to
establish a standard which would be outlined in another one. It\'s only
in very rare instances that we find it\'s necessary to establish a
standard so much again for a consumer label as much as what are the
minimum threshold of a program that we would want to affiliate ourselves
with.

Because at the end of the day that firm wants to sell that product with
a claim. Is it going to have to ask us for approval of that claim?
You\'re going to have to ask FDA, FSIS, or obviously FTC has its
involvement. We go to the Better Business Bureau. That\'s another avenue
that claims can be taken against and we\'ve had to deal with that with
programs that USDA has associated itself with.

Some people who have taken exception to the plan and actually filed a
petition with the Better Business Bureau at the same time to be followed
by FTC approval, with USDA. The Better Business Bureau in some cases
takes their action more quickly.

DR. LAYTON: And then one follow question. You indicated or I heard you
say you were probably dealing with like nine or ten million animals?

DR. MORRIS: Yes.

DR. LAYTON: Out of 90 plus million?

DR. MORRIS: 96 is the U.S. herd.

DR. LAYTON: Okay.

MS. TUCKER-FOREMAN: Yes. Who is not a voluntary program, correct?

DR. MORRIS: Correct.

DR. SCHECHTMAN: Country of origin.

MS. TUCKER-FOREMAN: I know this is not a voluntary program either but
would you just say a word about AMS\' role in the school lunch program,
qualifying products?

DR. MORRIS: Sure. USDA purchases roughly a billion dollars per year in
commodities for the Federal Feed Program. These are non-price support
commodities so it\'s primarily a red meat item, fish item, poultry item,
egg product, fruits and vegetables. So those are the five things.
Obviously, commodities like dairy, grain, those are the things that are
handled in a different manner. AMS provides services and off-site
support.

That billion dollars per year goes towards a variety of different
federal aid programs, the largest of which is the National School Lunch
Program which serves over 30 million kids per year. The National School
Lunch Program is a per-meal entitlement in schools with children who
deserve free or reduced stipends. A percentage of that, 12 percent of
that has to go towards what we call commodity credit. So they get a
check for a little over \$2.00 per child. They get the free milk. A
certain percentage of that, 12 percent, they have to actually use as a
commodity credit.

So they basically go up on an ordering range and order different
commodities with AMS involved with them so we buy large volumes
obviously of beef, or, pork, or, chicken, of all fruits and vegetables,
of eggs, fish, and a variety of other things. We also do what we call
surplus removal purchases and a variety of other things that we buy food
for that go into Second Harvest, Take Back, Native American Reservation
Elderly Feeding Program, a variety of others.

For all of those we service the contracting officer and in that role
what we do, and make sure the products are in the form of a
specification. So, we write a specification for the kinds of commodities
we will buy. There are certain requirements around that. They\'re not
subjective to anything you could determine, like domestic origin, for
example. We require that all the commodities that we buy be domestic and
that means the animals can\'t be imported direct for slaughter.

For example, Wagyu and things. We require our approved vendors that they
have plans in place to assure that they comply with the forms and we
actually have stationed employees at those facilities during the
manufacture of our products or subject them to an audit based system.

MS. TUCKER-FOREMAN: So, you write the specifications to what can be
purchased.

DR. MORRIS: Right.

MS. TUCKER-FOREMAN: You have, for example, zero tolerance for
*Salmonella, E. coli* 057:H7 as well as domestic.

DR. MORRIS; For ground meat. Just for ground meat.

MS. TUCKER-FOREMAN: For ground meat. As well as domestic origin for all
the products.

DR. MORRIS: Right. We do write all the standards. In fact, last week \--
there are three programs in the agency to purchase commodities. There\'s
a program that purchases all the meat, fish, poultry program which
purchases all the poultry and eggs and fruit and vegetable program which
purchase all the fruits and vegetables. Each year we have an annual
commodities industry conference. We bring all of the vendors together,
meaning all the major packers out there and talk to them about our
upcoming purchase requirements and that\'s when we roll out all the
specifications.

Those specifications are written by us in consultation with the industry
and we try to keep the specifications to what we call the top tier of
buyers out there. We do not ever want to be accused of or at least have
a battle claimed that we\'re a bottom feeder or we\'re refusing to do
business with firms no one would choose to do business with or buying a
product that no one else would buy.

MS. TUCKER-FOREMAN: The domestic origin for the directive is from
Congress, is that right?

DR. MORRIS: It\'s a directive from Congress and it\'s interpreted by us
through what we call an optimum watch so we actually define domestic
sources internally. The domestic origin requirement actually is
different from the United States country of origin as defined by COOL.
Again, COOL, especially in labeling, speaks to retailers as defined by
the Perishable Agricultural Commodities Act that, farms that purchase
annually at certain levels of fresh fruits and vegetables.

COOL is a retail law and domestic origin relates to products determined
by the federal government.

MS. TUCKER-FOREMAN: Just one more. You generally work with the industry.
They can be by Congressional directive or by the Secretarial directive.
Are there any other ways that your specifications are shaped?

DR. MORRIS: That would be the three. We don\'t do them. They\'re
literally written. Right now, it\'s certainly not a secret, our ground
beef programs were challenged in Europe. The purchase requirements that
we are contemplating related to animal welfare. It was a Secretary-level
issue. We\'re preparing that, we proposed a certain set of requirements
to the industry last week in Kansas City at a conference and as
outgrowth of that we are preparing a decision for Secretary Schafer now.

So, that\'s an issue that obviously the first day on the job broke. That
is an issue that is near and dear to his heart and we\'re certainly
going to give him an opportunity to craft what rules are coming forth
this year for the National School Lunch Program and our purposes will
begin roughly in July for delivery start time for the schools.

MS. TUCKER-FOREMAN: Thank you.

MS. SULTON: Guy.

DR. CARDINEAU: Your PVP and QSA programs are clearly focused on exports,
but what about imports? Do you use certified import materials as well? I
mean, we talked about organic certification and one of the things we
learned in a presentation by someone from ERS is that we\'re importing
probably 70 percent of our organic produce and it\'s labeled organic
certified and, you know, I\'ve known that they\'re actually being
inspected by USDA inspectors.

Do we really know that it\'s following our organic certification
procedures? Do you have a similar situation going on with meat?

DR. MORRIS: We do do imports as well. We actually are also an
accreditation arm for that program for foreign certifiers so we had
teams go to China, for example, which was \--

DR. CARDINEAU: Well, that\'s why I asked the question, actually.

DR. MORRIS: There are actually no accredited Chinese certifiers but
there are three or four, I forget the number it is now, three or four
certifiers both in the United States as well as based in Europe that do
do business in China and then ship their products into the United States
with a USDA certified stamp. So, we do do the import side. We also have
the PSA program that provides services to other world markets. The
Natural Beef Program is one that is one that we actually verify as well.
That\'s an Uruguayan based program for export into the United States.
So, it\'s both ways. We do imports and exports. It just so worked out
that our largest one, Farmway, are domestic livestock producers, so
that\'s one we talk quite frankly about.

We can talk about certified Angus beef for example. We have a
relationship with CAB for domestic products, direct order products, and
CAB also sources from plants in Canada and they ship products from the
United States as well as the third market.

DR. CARDINEAU: What is the definition of certified Angus?

DR. MORRIS: We have a schedule called GOA. We have a lot of the carcass
and back. Certainly the most challenging part of the certified Angus
beef program is has to be the upper two-thirds towards the modest,
moderate, or, upper two-thirds towards the prime beef on the carcass
side. Animals without a discernible hump so that means it\'s not coming
from *Bos indicus* breed cattle on the carcass side. There are some
carcass weight requirements. There\'s a calf thickness requirement.
Leaner, lighter carcasses. The reason you want lighter carcasses is so
that you don\'t have a 12 ounce steak that\'s paper thin. It has a very
large ribeye. And then you get a lot of animal carcasses which are 51
percent black coat color. So, things like a black baldy would qualify.
In dairy conformation, a Holstein would not.

DR. CARDINEAU: So they don\'t really have to be Angus?

DR. MORRIS: Clearly the standard has developed into what\'s called the
American Angus Association which is a national registry for the Angus
breed. The purpose of the CAB, wholly owned by the American Angus
Program, was to build demand for Angus genetics. Animals which are
black, primarily black in coat color and do not appear to have the dairy
or Holstein breed clearly have Angus genetics in them but they felt it
was in the best interest of the American Angus Program obviously to
allow certain levels of outbreeding to provide more efficiency and
variety.

It\'s not a genetics-based program. We do offer genetic-based programs
which actually can tie back to genetics. CAB has a specification for
both the live animal as well as the carcass. Again, that\'s standard is
developed by the American Angus Association on the survey.

DR. CARDINEAU: So a certified black Angus is not necessarily 100 percent
black Angus?

DR. MORRIS: Correct. It could be Blackhawk which is a cross and will
still qualify. The issue that you really get into, you\'re not going to
have obviously a Charolais or a lot of continental European breeding
that\'s going to qualify because of the upper marbling requirement.
There just aren\'t enough breeds that will hit that level of marbling.
It\'s a very small percentage of field production that has kind of
marbling and Angus really has the genetic percentage of the marbling.

MS. SULTON: Alison.

DR. VAN EENENNAAM: You spoke a lot about labeling programs that are
voluntarily entered into due to process-based labeling, organic being a
classic example. Are there any mandatory process-based labeling programs
for products that have no discernible difference in terms of \--

DR. MORRIS: That\'s a regulatory program that relates to a process where
the animal was born. Obviously that is a regulatory.

DR. VAN EENENNAAM: Would mandatory process-based labeling on certain
things that would be unique to that State? Do they have that right to do
that?

DR. MORRIS: As long as it\'s not in conflict with your laws. States have
a variety of authorities, grants, yes, for intrastate commerce and some
programs which we\'ve associated with have that. Municipalities, for
example, could have ratings. They could have a mandatory rating. They
can choose Washington coming out of Chicago and actually require a
graded service that\'s provided for a certain municipality, they can
require that as long as it\'s not being anti-competitive or it\'s not
presenting any challenge to the trucks and interstate commerce federal
tends to stay out of it.

MS. SULTON: Jamie, Larisa, and then Carol.

DR. JONKER: On the voluntary process side you talked about programs that
were all meat programs and I have a short list of other animal products
and I was wondering if they could go through an AMS process or a state
certifier like dairy. But I have a grass-fed dairy milk chain that\'s
standard.

DR. MORRIS; And I\'m sorry. I tried to have those programs or something
that of the examples I used for meat. Just recently I was at Fair Oaks
Dairy which is a dairy farm funded in Louisiana that was a USDA
process-verified farm for environmental management for example.

So when you walk in you will see, and this is a further example of
public/private cooperation, Validus was actually the company that
provided certification for their environmental management. We had
process verified Validus, so, you see the USDA process verified shield
because their certifier for their environmental management system for
Fair Oaks Dairy is accredited by USDA under a certified program, when
you walk in it\'s very prominent, Fair Oaks Dairy, and you see it.

DR. JONKER: So for a variety of things, eggs, flavor, oils, fish, all
that?

DR. MORRIS: All of that. All of that would absolutely fall under our
purview.

DR. JONKER: Thank you.

DR. MORRIS: In fact, on poultry, BJ\'s locally if you go, they sell
Perdue 100 percent vegetarian-fed chicken and has a USDA process
verification program on their own producer. It comes from one specific
plant. They have their own processor to verify it\'s vegetarian instead
of a USDA processor.

MS. SULTON: Nancy.

MS. BRYSON: This is a similar question, Craig. We were discussing the
definition of livestock before under the Animal Welfare Protection Act
about farm raised animals. You\'re using it slightly differently. Can
you give me what is your definition?

DR. MORRIS: We obviously make the break just along party lines in terms
of for whatever reason our poultry programs oversees broilers, spent
hens, breeder hens, or, broiler production, turkeys, reds, that\'s all
on there. Ostrich, that\'s all on their side. Items like that primarily
in red. So, it\'s beef, pork, lamb, veal.

We also have llama under my purview. There\'s just a variety of other
\-- possum is under my purview. That is the claim, it is not at all tied
with the definition of livestock or who within the agency has authority
under that piece. And fish, for example, fish falls under my program.
It\'s not livestock by that standard but it\'s just working on \--
organic is the exception to this.

MS. TUCKER-FOREMAN: I wanted to go to the grading standards for just a
minute. Your grades, prime and choice.

DR. MORRIS: Select, standard.

MS. TUCKER-FOREMAN: Select. It\'s generally based on visual
verification, intramuscular fat, then \--

DR. MORRIS: Maturity, marbling. Those are the two common factors.

MS. TUCKER-FOREMAN: Indication of taste and tenderness, correct?

DR. MORRIS: Correct.

MS. TUCKER-FOREMAN: So if you\'ve got a transgenic animal, a genetically
engineered animal that managed to pass the test for taste and tenderness
without the fat would you have to change the grades to accommodate that?

DR. MORRIS: It\'s interesting you said that. What we\'ve established in
AMS are a series of working groups right now, not just for beef but for
pork and lamb as well. We\'re working with the industry and actually
have a pretty large working group meeting set up for what\'s called a
reciprocal meat conference. This year it\'s going to be at the
University of Florida.

We are very conscious of that. The National Beef Association funded by
these four projects spent a lot of money, producer money, in
investigating genetic indicators of tenderness and we are very cognizant
of the fact, and a lot of packers also are looking at the these
objective tenderness measurement systems. Tyson Food was the largest of
which was very aggressive in looking at an online system for carcasses
to determine their tenderness independent of marbling.

We\'re very conscious of that. I think what we\'re looking at in the
near term is that in our Audit Review and Compliance Branch begin to
associate ourselves with some of these guaranteed independent programs
that are already in marketing. Again, we tend to be somewhat reactive in
some of our programs. We see a market niche has developed and then we
try to come in there and try to provide our independent certified
verification services.

Right now we have contemplated a complete overhaul of our grading
system. We are trying to associate ourselves with some of these
predictive genetic research initiatives that are going on to determine
the consistency standards of products regardless of marbling.

MS. TUCKER-FOREMAN: Oh, as I recall, back in the early 70\'s when the
price of grain went up radically and the people were finding it very
difficult to find grain and characteristics I think that\'s when the
select \--

DR. MORRIS: Select grade change. I think it was \'86.

MS. TUCKER-FOREMAN: I think it was first proposed.

DR. MORRIS: Yes. That is important and you raised a good point as part
of that initiative because at the time we used to call that grade "good"
which no red blooded American would say at the dinner table today, and
we should change the name of that grade which was technically our third
highest grade which was select which has certain less negative
connotations to people. We were part of that self-development. Consumers
don\'t have a subjective term. They had to educate themselves on what
that grade meant, the difference, and they went towards the farm.

I would be hard-pressed if I didn\'t know anything about the industry to
make a prime choice and this is select and which is the best.

MS. TUCKER-FOREMAN: There was lean and then it required \-- I think I
first caught sight of it because it was required by the grain to reach
the grade.

DR. MORRIS: In the 70\'s too what was happening at the time, it wasn\'t
even just \-- it wasn\'t at that time just the grain costs as much as at
that time we only had a grade and did not grade cows in the United
States which developed marble and because you had further change going
on in the United States it would become a different model. But we
understood those markets were existing, especially California.

MS. SULTON: I think we\'re coming close to our lunch hour so we can have
two final questions. Michael and Leon.

DR. SCHECHTMAN: Yes. This is just a very general question. You\'ve
talked about a whole range of programs. And, you know, the committee is
thinking about how these kinds of things might be assigned to procedures
having to do with genetically engineered animals. Can you give us an
idea of sort of the growth in AMS programs and the function over the
last 10-15 years in the livestock area?

Can you tell us sort of some idea of the level of expansion of programs
and how much money is devoted to them?

DR. MORRIS: Well, yeah. We have seen for some time in the industry a
need to consolidate the long-term demand for services. We are prone to
working very closely with the industry on the implementation of
objectives and instrumental policy to perform our services and it\'s not
a leap of faith to know that at a point that you can have a machine that
has gone through USDA Choice as accurately or more accurately than a
human can while you would require them to be there.

They can have a documented part of that system, for example, for all
these other things we discussed like a documented management system for
the operation of the suggested instruments. We\'ve seen this for some
time so it\'s part of all of our grants in the agency, it\'s not just
the ones in seeds and fruits and vegetables and poultry programs, dairy
programs, cotton programs as well.

We\'ve got all agencies vested in our audits. That\'s why we\'ve taken
our own work force and trained them. Ours was the first just because of
things like mad cow in 2003. It actually could go so far in establishing
a separate branch for outgrowth. So, we\'ve put several million dollars
of what is our grading revenue and priming the pump to establish these
audit-based programs so that we don\'t just provide our services at a
cash cow level, which is where virtually all our resident players are
with the commodity and we provide audits across the stream.

The issue you get into, especially when we get into not just
certification of producers, accreditation of certifiers that then go to
producers, you don\'t have a lot of revenue so it\'s a very complicated
system at my level in ensuring that all of your auditors are performing
enough billable hours to support your overhead included because those
services pay a portion of everyone\'s salary even at the departmental
level because we lose off the top about 8-10 percent.

So, that\'s where our structure comes in. Right now we\'re sitting on
about 25 employees in my office, the compliance branch, and that\'s more
than FDA\'s people. So, it is much larger and we\'re much larger because
of our industry, we hate to say it, forced uptake, and a lot of these
services do excellent compliance. They really cause some of these other
services to look somewhat \--

MS. SULTON: This will be the last question.

MR. CORZINE: The question I have you kind of alluded to it. For example,
the example that you used for the natural label that you help with. Do
you actually help with defining what that natural is or you just assure
that they do follow the process they presented and with that is there a
tendency to default to the Never Ever 3 and then as that as it all goes
along at the end of the day do you focus and use your logo say on their
packaging?

DR. MORRIS: Great question. On the claim, let me say that in general I
am never a proponent of us having to develop a standard. I feel as
though we are far better as an agency if we\'re simply the independent
third party verifying that standard is being met. Only in very rare
cases would we determine it to be necessary for us to go in and fill a
void in actually developing standards.

We feel that the commerce out there is just too wild, wild west. We
associate ourselves with a program at too low of a level that might
actually be complicit and objectionable. So, we determine that we have
developed a sort of minimal threshold.

Natural actually has a standard that\'s maintained by the Food Safety
Inspection Service that the product which is raw and minimally
processed. Basically, a steak from an animal that was kept in a barn
stable and treated with grass milk, all of that, as long as that steak
is a minimally processed steak, a raw steak, it is qualified for
natural.

The problem we have is a lot of these programs that are marketing
process as "natural" also are putting on their packages things that
relate to the way the animal was raised. So, they\'re participating
somewhat in the consumer confusion that you could argue. And there was
in our rulemaking a comment about the National Beef Association based on
the study they did, took the consumer out of it. When they see the term
"natural" you don\'t have to be necessarily associated with the whatever
processing standard was in it.

It was in that context that when we were looking or being approached
frankly by the firm saying we want you to process certify our natural
program that we offer what if they just did antibiotics and we didn\'t
do drugs, we wouldn\'t associate ourselves with that. That\'s why we
undertook what we call a very laborious process of trying to herd those
cats together and come up with a standard.

Then we found that we were having difficulty because when we opened the
comments, if you want to go through 44,000 comments about a naturally
raised marketplace, a lot of people associated naturally raised with
animal welfare system. That was not even something we were contemplating
frankly under the proposed standards. So, it just became difficult for
us to say this is what it is and not one of the divisive issues.

We never want to be divisive. We want to play a role in facilitating.
Don\'t take their word for it, take our word for it. We don\'t want to
steal anything, frankly. Another constituency out there saying, USDA,
you\'ve been complicit in this consumer fraud and the market describes
as naturally raised the animals have to be black, for example, which
would meet our three prong standards. That\'s why we had Never Ever 3
sort of unilaterally, so we could kind of not sit on the sidelines
because our argument was these programs are out there. Emphasize the
approving of it, under the natural programs, if the meat is minimally
processed, it's "natural," having nothing to do with the way the animal
was raised. Under Never Ever 3 we feel like we filled a little behind
the scenes to help, you know, fill that void with producers out there.

But on the naturally raised we\'ll just have to \-- that\'s an issue
that is very near and dear to our mission and we\'ll see where it goes.
I would like to say that we have going to have final marking standards
out before the end of this Administration. That\'s our desire. The
comments, as you read them, are very fair. They\'re very hard for us to
ascertain what is that, frankly.

MS. SULTON: Okay. I want to thank Dr. Morris.

DR. SCHECHTMAN: I was going to say we\'ll have copies of the handout of
the slide presentation. We don\'t have quite enough \--

MS. SULTON: We still have some.

DR. SCHECHTMAN: \-- and the audience and we\'ll have more right after
lunch.

MS. SULTON: We would ask that there are lots of restaurants to choose
from across the street and very close by and with that in mind if you
could return at 1:30 so we can stay on schedule we\'d really appreciate
that.

(Whereupon, a luncheon recess was taken at 12:24 p.m.)

[A F T E R N O O N S E S S I O N]{.underline}

1:38 p.m.

MS. DILLEY: So, we have proposed a conversation about the definition of
issues and primarily one is what is referred to as genetically
engineered we\'ll probably use the same documentation we\'ve been using
for all our reports which I just picked up the last report, the
coexistence one, and it\'s still used there which is genetically
engineered refers to organisms or products derived from them to produce
recombinant DNA processes.

So, that was one definition that was taken from some of our other
reports. And then Jim had been talking, I think, that the insights were
good and relevant so we can go ahead with what\'s proposed, but your
thinking was?

DR. BUSS: Well, earlier we were talking about the definitional issues
that we\'re talking about earlier and I guess we were of the same mind
that when we\'re looking at these topics for example at a fairly
substantial element we were discussing I really think it makes less and
less difference as to the definition.

And frankly given the compressed time schedule for getting this done it
might have to serve us well and we need to go with that and actually be
more clear is one that Greg talked about earlier and I believe is good
and also avoiding talking about agency responsibilities and so on. And
let\'s move on and focus on the topics at hand rather than going off
when we have so little time.

MS. DILLEY: So topics you\'re referring to are the key issues of
governance over transgenic animals and clarity around part of that
discussion, but I want to come back to see if people had any issue with
not defining, having the original, and finding different ways of
narrowing the scope and that\'s really at the 50,000 foot level less
important to do if we\'re looking more broadly at issues of government
at large.

So any positional thoughts on that or questions about that? Okay.
Michael.

DR. SCHECHTMAN: Let me just follow up. So we should be talking about
genetic engineering, for food or non-food animals, so, you\'re not
restricting it in any way so as to be talking about any kind of animal,
is that what you\'re saying?

MS. DILLEY: It\'s clarity at a very high level. We\'re not trying to
figure out a piece and I think the other piece of it was when we talked
about just scanning what do we mean by transgenic animals, we had
placeholders in here in the outline anyway to number 3 under context was
transgenic animals and we had a qualifier that said to follow in USDA\'s
purview but we could just say transgenic animals that are being
developed for commercialization and do a little bit of that scan just
for background for readers of the paper.

So, Jim, did you want to add to that? Greg? Okay. Greg, go ahead.

MR. JAFFE: I guess I don\'t have a problem not doing a definition but I
think you need to put some content in so I guess I\'m not \-- there\'s
sort a middle ground there. There\'s a very set definition and no
definition.

What I would want to see is something more like the issues that have
gone in this report came out from us generally looking at three types
of, and you say something about cattle and sheep and fish and primarily
for food use, and we could just give a couple of examples and maybe
saying and, you know, goats or cows used for non \-- you know \-- as
factories for production of pharmaceuticals or whatever.

Just put examples of the things that were primarily in our minds and get
off the cite. I generally was not thinking along the lines of pet
animals and this and that.

So, without giving a broad \-- you know \-- without actually defining it
and putting all the boundaries which are difficult to do, one\'s in,
one\'s out, I think the reader is going to need to go and primarily
focus on these type of obligations that we were primarily not focused on
the intent of applications because if you are talking about dogs and
cats it\'s very different issues to commercialization that we\'re really
not focusing on and that people don\'t have the expertise on.

We all mean something by food animals and we\'re primarily talking about
these commodity type things. We\'re talking about the fish and the
shrimp. I think there\'s a way that we could write two sentences and say
these are the kinds of applications we had in our mind, the types of
applications we had in our minds when we came up with our issues of
government, the kinds of \-- these are some of the applications that we
clearly did not focus on without really putting a bright line under
what\'s in and what\'s out.

MS. DILLEY: All right. Daryl, did you want to follow up on that?

DR. BUSS: Yes. I don\'t have an issue with that. However, if we do so,
we probably should just flip it and say we\'re doing it within the
agricultural characteristic.

MR. JAFFE: Right. No, I was thinking more along the lines of things like
cattle and sheep and goats and, you know, define such as and fish and
shrimp.

MS. DILLEY: That seems very consistent with

adding \--

MR. JAFFE: A few of the things we clearly have in mind and that\'ll give
it at least some context. If we pick those examples right then it\'ll
give it some context.

MS. DILLEY: Jim.

DR. ROBL: I agree. I think that rather than spending more time on that
because we can always come back after we go through topics and determine
in general what\'s this and these are things that are completely outside
of that, outside of our focus of discussion, so, I don\'t think we have
to have that definition besides what we have right now.

MS. DILLEY: Okay. I think we\'re on the same page in terms of not going
even a bright line definition and spending a lot of time talking it. And
then we can come back and we\'ll probably add some of the context into
what animals are most on our minds when we were considering some of
these issues. So, anything else? Any questions from the rest of the
committee?

All right. So we have until a quarter after three for this discussion on
the agenda and we thought we\'d go right into the discussion. Currently
we have the topics and the elements that are key issues of government to
transgenic animals, again not to go into who is doing what, the agency,
but more these are issues that the government should be engaged in was
the terms used, or, mindful or, thinking about and may have some role in
and then look at some of these topics and get a first crack since this
is the first time you\'ve seen it since we\'ve had the preliminary
brainstorm during March and then the work group just a couple of rounds
trying to organize them.

I think the one thing that we\'ve already talked about was the import
issue but we thought we\'d go through it and see what we need to add and
then we sort of get a little more discussion around each of these
sub-topics and get a little bit more clarity; does it make sense; do we
remember what we talked about, not that we have that, but to add to that
discussion and so flushing that out a little bit.

Carol, did you have a question about the process?

MS. TUCKER-FOREMAN: No.

MS. DILLEY: Okay. All right. So, and then we\'ll break at quarter after
three and then we should have public comments at 3:30. So, just so you
have a concept of order of this afternoon. So, with that, we\'ll open it
up for looking at what\'s currently under topic, the B section that\'s
in there, key issues of government of transgenic animals \-- genetically
engineered animals. Sorry. We\'ll stick with that terminology.

All right. Carol.

MS. TUCKER-FOREMAN: I would like to request that number 2, food safety
determination be moved up and made number 1 since the reference is to
animals that are generally used for food. It seems to me that before you
would have this analysis you would have to have food safety
determination.

MS. DILLEY: Those are two issues. I mean, one we just took away that,
you know, specific to food and animals because we thought it wasn\'t
enough for you to more thoroughly define it. At least I\'m pretty sure
we just did that because it stayed up at the 50,000 foot level.

And then I don\'t know if we\'re intending to set priorities. But
certainly food safety should be on the list.

MS. TUCKER-FOREMAN: I really think that if we\'re talking about it, you
know, mostly we have talked about those things, what people eat, and
food safety comes before any cost-benefit analysis in my view and it
really needs to be first on the list.

MS. DILLEY: The larger question I\'m asking and I\'m not saying it so
much as to see, I think it\'s a procedural issue of whether we are
planning to ultimately set priorities on this list or make sure we\'ve
got the list comprehensively and, so, just something to throw on the
table. I don\'t know who was first, Jim or Carol. Jim, I think you may
have gone up first.

DR. ROBL: I would agree if we aren\'t looking for priorities with what
Carol had mentioned, food safety determination, but I\'d also say that
in terms of benefits analysis and evaluation of alternatives you have in
your little comment down below, to me is that something that truly is a
government responsibility or is that the industry that is actually
trying to commercialize a particular genetically modified animal.

So, in my perspective, I would substitute safety and second animal
health and welfare and the benefits analysis I think would require a
further discussion to determine exactly what that would be and it would
probably be significantly lower on the list.

DR. SCHECHTMAN: Would you restate that? I\'m not quite sure I
understood.

DR. ROBL: What the comment was on benefits analysis?

DR. SCHECHTMAN: No. You said two things. That was one and then I thought
you re-ordered the stuff as well.

DR. ROBL: Yes. I would put benefits analysis somewhat much lower on the
list because I think food safety, animal health and welfare, and as I\'m
looking at this even environmental impact are probably of higher
importance.

MS. TUCKER-FOREMAN: You raised another issue, Jim, which I think is
worth us discussing is the benefits analysis a government responsibility
or is that something that industry has?

MS. DILLEY: I think more importantly we need to flush out what we mean
by that terminology, benefits analysis. Daryl, I know you had your card
up, but Stephanie, Nancy, and then Guy.

DR. BUSS: Well, I certainly agree with putting food safety as number
one. I would advocate for not \-- in fact I would specifically suggest
we indicate these are not in any priority order because it seems to me
now we\'re giving a normal priority for very unique circumstances given
transgenic animals.

And, so, I don\'t have anything specific in mind but I can imagine that
given the nature for some transgenic animals might place whatever \--
much higher at the top than for some other application. I\'m not sure
that really serves a purpose. Rather all the interests indicate
somewhere in the opening comments that sequence should not necessarily
imply right origin. Must we develop \-- are looking for a global
problem.

MS. DILLEY: Okay. Stephanie and then Nancy.

MS. WHELAN: I agree with Daryl. Basically I think if we talk about a
roadmap people think of 1, 2, 3, 4. If we get rid of that roadmap I
think we\'re talking about key issues then there isn\'t that need to
prioritize. So, if we take roadmap words off there and cross them out
then we\'re not thinking about this as some directional map and then
give the issues in any order.

MS. DILLEY: That may be something along the lines of it\'s dependent on
the animal we\'re talking about, some of what you were saying.

MS. WHELAN: There is no order preference. It\'s just issues.

MS. DILLEY: Guy and then Mardi.

DR. CARDINEAU: I guess what I hoped with that first bullet I thought
there was a word missing and it might be risk so maybe it\'s a
risk-benefit analysis and actually all the other things fall in line
with the risk-benefit analysis. I mean, animal health and welfare,
environmental effects, evaluational and so forth. Is that what we\'re
really talking about here? I mean, I\'m fine with, if I\'m understanding
correctly, the producers are the ones that are looking at benefits.

I think that part of our obligation is to consider what the risks are
conversely, are associated with those benefits. I wondered whether or
not saying risk-benefits analysis might not be a better way of doing
that.

MS. DILLEY: Nancy and then Mardi.

MS. BRYSON: I think that you generally don\'t look at benefits unless
there\'s a statutory obligation to do this. The risk-benefit idea
actually I think derived originally from the frustration that what
Congress mandated a decision to register something that still is other
things based on what they had written as benefits. There are a whole lot
of procedures that apply to any regulation that is developed such as
economic analysis, marketing impact, the environmental effects are a
major federal action, but those all relate to what the subject matter of
regulatory action is.

And I don\'t know that we know what we\'re talking about, about what the
regulatory action is. Maybe it\'s approval of transgenic animals for a
food safety program or maybe for some other purpose. So, I would think
that risk- benefits analysis doesn\'t really fit.

I agree with Guy that most regulatory decision- making today has a
risk-benefit component but I\'m not sure that\'s what it\'s really
called.

MS. DILLEY: So the question of whether this is on the wrong list.

MS. BRYSON: Yes. I mean, you certainly do a risk assessment in here. A
risk assessment has to be some kind of regulatory decision but what it
is varies.

MS. DILLEY: Mardi and then Greg.

DR. MELLON: I agree with Nancy. For the most part, if we\'re thinking
about regulation and regulatory framework, benefits are not explicitly
taken into account. You just proved that food is safe or whatever. And,
you know, benefits are not required to be considered and are often \-- I
think people think there are policy reasons that consideration of them
is discouraged because in fact it\'s quite a difficult assessment and it
requires analytical tools that, you know, often are not in the hands of
regulators.

On the other hand, if we\'re looking at this document as one that deals
with issues that ought to be considered as folks are moving these new
products forward the alternative analysis, the need analysis, the
question of whether there are real benefits associated with the process,
is a big part of the debate.

I mean, I spent a lot of time on my comments to the FDA trying to say
somewhere we\'ve got to be able to ask the questions of whether we need
cloning, not just whether a cloned animal is safe, so, I don\'t mind
having it in there highlighting the fact that a public discussion is
definitely going to include a notion of whether you need or want risk
benefits associated with a product, but that is probably not going to be
strictly speaking in a regulatory setting and on a product by product
basis.

MS. DILLEY: Greg.

MR. JAFFE: A number of comments. On the issue of whether we\'re going to
prioritized these things, I tend to agree with Daryl. We shouldn\'t do
that and I think he had good reasons for it. On the other hand, I also
agree with Carol that I still think everyone in the room thinks food
safety as topic A, in most cases the number one one, so while I don\'t
think we should prioritize them, I think we should discuss food safety
first.

The second thing is even though you say that people don\'t get down to
number 7 so I think the top one is say we don\'t prioritize but then
discuss food safety food as the number one concern for most applications
and the number one issue I think people think around the table so I
think that\'s the solution there.

The second one is I also agree with Nancy and others. I think, I mean,
most of our laws don\'t have a risk-benefit calculation put into them
specifically and a separate one that does. Some environmental statutes.
I think the food safety areas clearly don\'t. We don\'t have a balance
on food safety risks. We don\'t say, well, you know, killing a few
people is okay or things like that. We tend to say this meets a safety
threshold or it doesn\'t meet a safety threshold.

We don\'t look at product effects on different populations the way the
medicals make their case, so, that\'s something. I guess in my mind I
don\'t like the term regulatory here as headings here and I guess it\'s
been my way all along that the charter talks about regulatory.

I just call it safety issues or something else because I think that some
of the stuff is under commercial and marketing. You know, clearly
labeling can be a regulatory issue and so can one of the traceability
and tracking. Those can be regulatory and mandatory versus voluntary. It
can be either.

So, I don\'t want us to get locked into the term regulatory. We have a
familiar term here. There\'s safety issues or something like that. Food
safety, environmental safety, animal health safety kind of thing or
something. Then I think that better captures the sub-categories
underneath there. I think all areas, especially where government gets
involved in something that\'s regulatory, whether it\'s voluntary or
mandatory kind of thing.

Then my other comment about \-- I mean, benefits analysis. But clearly
efficacy does get involved in for example, drug safety, because they
also do drug safety under new efficacy they tell you, not that the
drug\'s safer to take, does it do what it\'s supposed to do for both
human drugs or animal drugs. The reasons why they did that I\'m not
going to go into, but so you could say, well, do you want the government
to decide not just that the transgenic animal is safe but does the
transgenic animal \-- are you getting benefit for what you\'re paying
for, then you do what you want to?

In most cases we just let the market decide, you know, for transgenic
crops as well, you know, does it kill the pests? The farmer will decide
that, you know, you let it out the government doesn\'t expect me to say
it does kill these pests, it doesn\'t kill these pests, this doesn\'t
work, and so people in the market won\'t buy it after a few years.

But we hear of places, you know, Agricultual Research Services around
the country, a lot of times they\'ll look for varieties and tell farmers
that varieties are a good variety for you and those are government
employees or people that are paid by the government who have done that.

So, we do have situations where the government does come in and talk
about efficacy or whether the products are worth the value that they are
they worth. So, directly you could put that in here under the sort of
areas if we wanted to, I don\'t feel strongly one way or the other about
that.

I do think if you want to get into the benefit risks and all the other
things to look at and do we need this I think it\'s under more of a
socioeconomic kind of analysis of some sort. So you could put that under
the marketing or somewhere else but you could put, you know, some sort
of, oh, it\'s an issue if one wanted to, the government\'s going to be
involved in, you know, is this the proper way to do it to solve the
problem and then we\'re solving it.

I have an opinion on that. Again, I\'m not sure that that would be a
deciding factor and would be information that might used in the
marketplace and people might be trying to decide if they still wanted to
buy it or pursue that product or not pursue that product.

Anyway, those are just thoughts I have.

MS. DILLEY: Those are good and I think the safety one made sense to me
and just as we\'re reconfiguring that one then I don\'t know what to do
with the last two.

Maybe there needs to be total participation and get clarity on those
with regard to safety, but then other question of whether you put this
cost-benefits discussion. I\'m not sure if that\'s the right category or
the ethical issues is the right category. Maybe that\'s socioeconomic or
other.

We need to reconfigure \-- figure out what topic we need and then how to
reorganize so I think that will be including more things and
reconfiguring is a good one.

Pat, Daryl, and then Jerry.

DR. LAYTON: I guess the question is, fundamentally was if we are
redefining to clear regulation of key issues of government and we\'re
looking at it from, you know, the 50,000 foot level, what are we trying
to say in a way that it\'s easy and it\'s non-FDA/USDA? So, how do we
say this in a way that makes sense?

Because I\'m a little lost on how we set up the issue. So is it that as
a committee we\'ve looked at a series of topics and no matter who
governs or what governs these are the items of governance that need to
be taken in place no matter what because it could get eaten, food safety
has to be done, or, environmental impact has to be done?

What are we trying to say in terms of key issues of governance? Is it
that it should be regulated or it shouldn\'t be regulated? It should
have a process, it shouldn\'t have a process? I don\'t understand what
we want to get to here at the 50,000 foot level of what we\'re trying to
say. The topics are all development. I\'m happy with the topics. It\'s
what we are going to say about a topic. Does that make sense?

MS. DILLEY: I think that\'s a conversation that we want to have.

DR. LAYTON: Yes.

MS. DILLEY: I mean, that\'s exactly how you set it up and we need to
talk about those categories a little bit more?

DR. LAYTON: Yeah.

MS. DILLEY: And then we\'re not deciding who should do it, but we think
this is important and this is why, and then \--

MR. JAFFE: We are deciding how this is involved in some way.

MS. DILLEY: Yes. Right.

MR. JAFFE: We have to figure out how that \--

DR. LAYTON: But the point is when we\'re looking at it right now, does
somebody know how to get through it, that\'s one thing, but we\'re not
talking that. We\'re now at issues of governance. So how do we set it up
so that we can flow through this without getting down into the weeds? If
you have some ideas, help me think through these.

MS. DILLEY: Nancy. Do you want to speak to that?

MS. BRYSON: Yeah. Well, I\'ll speak to that. If you thought about this
as any other new kind of technology, it\'s coming on the market, some
applications we see in the here and now. There may be other things,
there probably will be other things that come along in the future and
you\'re looking at it in the present day what are the things that we
would want to have in place to address that technology.

Certainly, you would want to make sure it was safe. Certainly you\'d
want to make sure that somebody would be in charge of making sure that
it wasn\'t anything that would harm the environment. You also want to
make sure that you\'re not setting up that is so detailed focus that it
couldn\'t involve the new technology.

You would want to make sure that there was an opportunity to discuss the
issues that belong to applications. You want to, and I was talking to
somebody about at lunch, is that you have to be sure that the new
technologies that are being applied to farm animals and they might at
some point become relevant or need to part of the process or something
like that. It\'s that kind of a situation.

Or the things might become relevant to a conservation program which USDA
has, which no one talked about. You just want to have in terms of
government to want to try to be as broad as you can in thinking about
where this could go and try to have a system to address any of the
issues that come up. Some of those are government, some of those are
marketing, some of them are international because they\'re
trade-related.

And we could sort these out by topics perhaps.

MS. DILLEY: Carol, you had a comment. I want to get to Daryl.

MS. TUCKER-FOREMAN: I was just responding off the top of my head to Pat.
I think I\'d probably say that you want a system that addresses food
safety, food for the animals, for the environment and that was
constructed in such a way that it was \-- that there was flexibility to
address the technologies and derive from a process that involved public
participation and transparency.

MS. DILLEY: That\'s what Nancy was saying as well. So, Daryl and then
Jerry.

DR. BUSS: Getting back to the roadmap. So, if we want to think about
government consideration then it seems to me that safety works well for
numbers 2, 3, and 4. It has all the requirements there. And so I wonder
if we\'re not dealing with two different issues. With Item E being
government consideration that would be safety, marketing, ethical issues
and then we\'re really talking about really item C, that part, general
characteristics of governments with public participation and
transparency, authority, and education of stakeholders and coordination
among agencies.

MS. TUCKER-FOREMAN: That\'s the substance process.

DR. BUSS: Exactly. It seems to me we\'re dealing with issues in the
process and they\'re all jumbled together.

DR. LAYTON: I like that.

DR. SCHECHTMAN: Are there two categories or three?

DR. BUSS: I guess we\'re now calling them under governance
considerations which would be safety without the regulatory and then
marketing and ethical and the next one is ethical issues and then
instead of saying number 4, other elements, instead having item C that
might be headed general characteristics of governance and that would
include public participation, transparency, clarity, and those other
three that are under now other elements.

MS. DILLEY: Yes, Jerry.

MR. SLOCUM: Much of what I was going to say has been said but it seems
to me that this benefits analysis or risk-benefits analysis doesn\'t
belong in the regulatory section at all and down in the marketing
section it belongs. I think it does belong. Surely in food safety and
animal health and environmental impact there\'s going to be a risk
analysis done. That\'s what it\'s all about. That\'s what that is.

So, the risk benefits should be I think put \-- that should be the
burden of the introducer of the transgenic animal or genetically
engineered animal. But wherever you envision that discretion, and I\'m
not sure it\'s marketing because I see the other elements of marketing
that look to be pretty governmental-type provisions, we\'re not
addressing, if you want to introduce it, we\'re really not addressing
any of this that we intended.

MS. TUCKER-FOREMAN: I think that\'s what Jim said early on.

MR. SLOCUM: And where \--

DR. ROBL: He didn\'t quite finish.

MR. SLOCUM: But where do we address the industry that would want to
avail themselves of these issues of governance, clarification of issues
of governance or do we?

MS. TUCKER-FOREMAN: I don\'t think we do.

MR. SLOCUM: Is it our intent not to or is our intent to?

DR. SCHECHTMAN: Can I follow up on that with a question of what the
committee means by governance and when you say there are issues of
governance does that mean that these are issues for governance to be
taken up by the Federal Government or issues of governance that need to
be resolved, the ones the committee thinks they need to be talking about
in the report?

MR. SLOCUM: We need to decide that because when we make a roadmap, as
you said Carol, it sounded like this is the way we get from the concept,
the introduction of market trade, production to delivery, okay, and your
basic question was do we want to even ask that question at this point?
Don\'t we want to talk about the kind of hurdles that these new
products, these new technologies, these new animals or animal products
have been cleared? There\'s two very distinctly different things.

MS. DILLEY: Isn\'t that part of clarity though? I mean, \--

MR. SLOCUM: No, not clarity in the sense of this. It\'s not clarity in
the sense of transparency clarity. That transparency clarity I think is
all about making this new regulatory process. It\'s transparent, it\'s
clearly made, the public is actively involved in it from the get go.
That\'s what I thought those words meant under the regulatory framework.

MS. DILLEY: Regulatory, you\'re now combining regulatory and marketing
and other things so is it the regulatory \--

MR. SLOCUM: The question, when we\'re talking about roadmap it sounded
to me like we were really talking more to the providers of the
technology than we were to the USDA. But now when we start talking about
issues of governance it sounds to me like we\'re talking more about
USDA.

MS. DILLEY: We are talking about USDA. And I guess stepping back to our
charges, knowing that these issues are under discussion by the
regulatory agencies themselves, the Administration, it would be hard to
talk directly to the a company because we\'re not speaking for the
Federal Government or making up that roadmap. That was the constant from
that discussion and at some point will become public, I assume.

MR. SLOCUM: I\'m not sure there\'s a benefit formed anywhere.

MS. DILLEY: Okay. That\'s how you\'re connecting the dots. Okay. Now
I\'m getting it. I\'m slow but I\'m getting it.

MR. SLOCUM: No, you\'re not slow.

MS. DILLEY: Okay. Greg, did you have a comment?

MR. JAFFE: Yeah. I was going to say governance is what lots of people
were talking about this morning. I think of it as government involvement
or governmental oversight of the area. We want to identify the areas and
there are a lot of different steps to take to commercialize transgenic
animals, you know, IP issues. Any company that does a benefits analysis
at the beginning of the project they\'re going to come up \-- if they
did a benefits analysis they wouldn\'t be doing the product. If they
think there\'s a market for it, then they\'d honestly think they\'d be
doing it. Whether that\'s made public or not for the end material to me
I\'m not sure I\'m going to put a lot of stock in their benefits
analysis. Time will tell.

If they\'re predicting they have a market, they\'re going to put their
capital into it. If it works, great, if it doesn\'t, they go out of
business. So, there are a lot of other steps. I don\'t think we even
have a clear roadmap, I never envisioned us talking about the commercial
steps, the company steps that they were going to do. It was always, what
is the governmental roadmap? What are the issues that the government
needs to get involved with as some product of this technology goes to
market?

So, whether you call it government involvement or government oversight,
whether you call it governance issues, I think we are talking Federal
Government. We\'re not sitting here talking about State and local
governments. That\'s a different can of worms and I don\'t think we\'re
all experts in and there are 50 states and I think we\'re really at a
national level, where should the government, what are the key issues
that the government needs to be involved in here and some of them may be
mandatory and some of them may be less than mandatory or may be
committees or giving the public information that will help them decide
if they want to buy the product in the market.

Some of them will be not even allowing it to meet certain hurdles in the
market. That\'s how I read it, whether you call it government or
whatever you call it, I personally like government involvement or
government oversight. Government involvement or oversight is a little
bit big. Oversight sounds too regulatory, but \--

MS. DILLEY: Nancy and then Mardi.

MS. BRYSON: I think I like the word governance because it\'s so \-- it
is so non-specific, but I think what USDA brings to the table is the
fact that is not a regulatory agency. I think the thing that it has to
offer in terms of the technology is all kinds of things that we\'ve been
hearing about and I think it\'s a set of tools. What pieces are
regulatory, another piece is marketing programs which in a way are a
safety release valve because they allow the way for producers to get a
process-verified program that lets them stand behind their product.

It\'s a way of letting consumers have access to a product that has the
characteristics they want. And, you know, it just seems like a good
thing and then there are already conservation programs and there\'re all
the research facilities that can be used and then in terms of providing
specifics about what\'s going on in the marketplace when we were doing
coexistence were, were also cognizant of the fact that it would be
really good if USDA did a better job in terms of getting statistics out
in time for agriculture breakdown.

To me, it\'s not really significant when you\'re talking about Federal
Government or State or local government. Because another unique thing
about USDA is the extent to which it\'s involved with, with State and
local governments. The whole agriculture system works because of that
network.

So, you know, I could envision long-term a situation in which, for
example, on animal welfare, if there were great State laws dealing with
animal welfare the Federal Government doesn\'t have to replicate that
but it is another piece of the governance structure for certain,
perhaps, applications of that technology which fit together.

So it seems to me we need to talk about using all of these different
things without being prescriptive or saying it\'s regulatory or
oversight which has some negative connotations.

MS. DILLEY: Mardi.

DR. MELLON: I\'ve been trying to focus on what\'s important about the
fact that we\'re working with animals. A lot of the \-- in many ways you
can just put up there, you know, if you were discussing plants, it
wouldn\'t be any different and, yet, for some reason we think animals
are different and we all know that they\'re going to be treated
differently and used differently.

So, I want to make sure that we capture some of that. To me it is one of
the very different things is that the ethical issues are like them or
not and well-defined or not are going to be front and center on this and
what makes animals different is that ethical issues can trump safety. If
there\'s lots of people, not everybody, but a lot of people can say we
don\'t want to go and have this whether it\'s safe or not. They\'re
ethically offended by it. We don\'t like it, whatever people\'s reasons
are.

But that is not conceivable to me as a conversation that would lead to
people not going ahead with the technology on the plant side but it
seems to me that the ethical concerns are serious enough, are subscribed
to by enough people, that they will alter that commercial impact that
they\'re going to be taken seriously.

So, it seems to me that, you know, this notion of governance and
encompassing the idea of sponsoring conversation or forum for a
meaningful discussion of ethical issues related to animals is really
important and that it will draw in some of the benefit considerations,
why people did not want them, why they did want them. But that it will
challenge some of the accepted mission of the USDA.

I mean, we heard today that they\'ve had a statute since 1943 or
whatever it was that promoted. If it\'s agriculture you find a way to
sell it. We just assume that all agricultural products are good and that
we\'re going to use taxpayer-funded programs and agency resources to
promote the sale of them. Maybe that isn\'t going to be the case
anymore. It\'s just because somebody decided to try to sell it, didn\'t
want to use government resources to promote the sale of that.

So, thinking through in a broader way what we want to use our resources
for and whether we want without any further thought to just assume that
if they\'re introduced they\'re going to be promoted as part of this
larger conversation that we will need to have in the context of animals
in a way that I think we did not need to have in the context of a plant.
Not to say that, you know, the appropriateness of the promotion of
products hasn\'t been controversial before, but this isn\'t that.

So, I\'d like to, you know, make the ethical \-- to put the benefits
discussion \-- to put more into the ethical issues, maybe more on just
this notion that providing one or more places where you can have a
meaningful discussion about ethical issues, but that should consider
issues of need, benefits, the appropriateness of, you know, a
government-sponsored promotion of the technology.

And then, you know, I don\'t object to actually having regulations.
It\'s one of the government\'s issues and to say that it\'s likely to
focus on food safety, on animal health, I think animal welfare probably
ought to go out, I mean, to ethical issues because I don\'t think
regulations do generally deal with animal welfare, but environmental
impacts are appropriate as part of regulation.

MS. DILLEY: Just a couple of things, Mardi. One is I don\'t think we\'re
ever going to come up with a perfect grid that separates these things
out and I think all the conversations we\'ve had and we\'ll probably
have more of them in terms of how to sort and reconfigure makes a lot of
sense.

I\'m not sure we\'re going to have a very clean "regulatory fits over
here and it doesn\'t fit over there" because it kind of blends in at
some level, but I think the best way to kind of organize our
deliberations is a good thing.

The other is, we\'ve got this placeholder over ethical issues and in my
mind a lot of what you said is in my mind the conversation we need to
have and we need to figure out how best to set it up and have it is what
does it mean to have a meaningful discussion about why do we need it, to
what end, those kinds of things, how do you put that together. Again,
not deciding that USDA is going to have the main role or FDA\'s going to
have that main role or, you know, an ethical body that\'s set up that\'s
different that\'s going to have that role.

We\'re not going to go down that road, but more why do we need that,
because animals are different than plants. What does that really mean
and what are we looking for in that? That conversation you need to have
and we need to figure out how to set that up. I\'m not sure we need to
prioritize that among other things at this point. I think you just need
to have a placeholder and then figure out how best to organize that
conversation.

DR. MELLON: I think that that conversation, this is regulatory
conversation, needs to be transparent, needs to have the elements of
transparency and participation.

MS. DILLEY: Which goes with Daryl\'s point, the substantive things we
need to do and the principles, I don\'t know what else to use, process,
both have to intersect to your point. I\'m not sure what cards went up
first. Adrian, Guy, and then Daryl.

DR. POLANSKY: I think thoughtfulness is kind of important when we\'re
talking about animal health and USDA and some of the programs you heard
about earlier. In a couple of those process-based programs, you know,
when you\'ve got a sick animal, to treat that animal with antibiotics. I
think that\'s a pretty huge animal health issue. I think it\'s pretty
much for some people an ethical issue to let that animal die and we
wouldn\'t do that to ourselves or to someone in our family or certain
family pets.

DR. MELLON: They\'re required under the organic process to treat those
animals.

DR. POLANSKY: But that\'s not the only process. But that\'s not across
the board. So, you know, I guess what I\'m saying here is that we need
to be very thoughtful here because there\'s some things going on now,
process-based, that have ethical issues that animal health issues,
animal welfare issues, and we need to be thoughtful as we go down that
road because it\'s not just necessarily dogs and cats in this particular
arena of discussion at least in my opinion.

MS. DILLEY: Guy and then Daryl and Nancy, do you have your card up, yes,
Nancy, and then Jim.

DR. CARDINEAU: I think that Mardi brings up a good point though with
regard to the general populace with regard to animal health. When we
plant corn nobody asks us about the density of the corn plants per acre
but they certainly ask about the density of animals per square feet or
pens or whatever.

We had a law passed in the State of Arizona about how much space a sow
has to be allowed to have. But if you think that is going to be an issue
and I think it\'s something that we should \-- it should be mentioned
and it should be brought up because these are things that in 25 years
there may be discussion.

There aren\'t too many people worried about whether our plants are
feeling bad or not, but I think people are going to be concerned about
what this technology may do to the animal, which, personally, I don\'t
think is an issue for me, but there are people that don\'t understand
the process and worry about that.

And I think it is an important consideration particularly if we want to
produce and be successful. Education is going to be really important. I
don\'t know how Jim or Michael feel about that. I think it\'s really
critical, a critical issue.

MS. DILLEY: Okay. Daryl.

DR. BUSS: Well, nice concept and I wonder if we might be well-served by
rather than starting with government\'s consideration I think we should
really begin by government\'s consideration common to both genetically
modified plants and animals with which we can go ahead and iterate all
of those that are here now and move on and then have a category,
considerations of special importance, or, something like that to
transgenic animals.

That really does narrow that down a lot, the animal health and welfare
and ethical issues. It doesn\'t mean they\'re zero especially with
plants, but we\'re saying this would take that to a different level. And
really pretty much dispense with all of those things like segregation
and branding issues, all of which are real, but having trouble being out
there, and really focus in on those things that are really different
instead of rehashing stuff we have for plants.

DR. LAYTON: We have covered those.

MS. DILLEY: Okay. We have a proposal on the table. Nancy and then Jim
and then Michael.

MS. BRYSON: I think I have to think more about that, Daryl.

MS. DILLEY: I do too because I\'m thinking channeling and and
segregation. Aren\'t there specific animal issues because plants don\'t
move around like animals do so -

DR. LAYTON: Pollen does.

MS. DILLEY: They do move around but I think they\'re different \-- I
don\'t know, maybe not. Leon, did you want to speak specifically to
that?

MR. CORZINE: Yes. I think you need to be a little careful there because
there are lot of differences in these issues we\'re talking about in
regards to animal count. There may be a few things in, labeling,
traceability, or go back to channeling on plants, but animals are a
whole lot different and I think the food safety determinations are
different. I think the environmental impact is different.

And I think we\'ve got the three up there that you need to have in that
category and, you know, food safety at the top and then, you know, we
aren\'t going to have it listed in order, but environmental I think
would be different than animal health and welfare.

But anyway, those are the three, and maybe that\'s under evaluation.
You\'ve got it under safety and regulatory and you don\'t want
regulatory. I wrote, just penciled in my own evaluation and then maybe
start in on these other things that are considerations under, you\'ve
got them general characteristics. So, I think the point is \-- because I
don\'t know if I agree with what Daryl said because we can\'t let that
flow so much because I don\'t think it should be a natural flow from
what you\'re doing with plants and what you\'re doing with animals
because they don\'t start coming back the other way.

MS. DILLEY: Jim and then Michael.

DR. ROBL: Well, I guess two items. Do you intend for this us to go
through this in some sort of sequence here or basically throw out
comments and responses? How would you like to do that?

MS. DILLEY: Well, part of that is, and I think it\'s been helpful to
kind of think through different ways of sorting some of these pieces and
I guess it would be nice to have some construct that people are
comfortable with makes sense logically.

I think the sorting out the general characteristics of governance from
what issues of government need be and then if it\'s safety or however
we\'re going to sort it, we need that as part of our work plan in terms
of how do we run through those and have the actual discussion and then
deal with the type of work plan from that construct.

So, I\'m trying to get some feel for this so it\'s starting to make
sense. Are we honing in on a way to think about what we\'re trying to
do; what conversation we want to have. So, I don\'t know if that
provided any clarity or not.

DR. ROBL: That\'s fine. When it comes to \-- I have my biases when it
comes to the ethical discussions. Particularly, I\'ve said this before
that I\'ve been involved in many of these which end up being your
opinion, my opinion, my religion, your religion. And I liked it better
when we actually had categories under that such as the animal health and
welfare which some people would consider to be a component of ethical
consideration.

Ethics standing out there on its own, again, is very much not just
personal opinion and unless there is a process to work through when it
comes to some consensus decision based on ethics then it does very
little good. It\'s like taking a vote and that\'s where you stand. So, I
do have some concern about this being that kind of discussion or
confined to government that they should have this as a component of some
governance program.

So, I think it needs to be broken down a bit more into something that\'s
actually manageable that can lead to some sort of a decision.

MS. DILLEY: Yeah. I mean, again, I think what we\'re trying to do is
highlight and we actually have to have a conversation at some point and
that\'s what we\'re struggling with is we\'ve got a placeholder here and
we can start a lot of times taking out the placeholders and we can kind
of talk about how do we want to have that conversation.

I think you\'ve got some points, Mardi has, and others as well. It\'s
kind of what do we mean by animals are different than plants, okay, so,
what does that mean? how do we go to that level of that in terms of do
we have a meaningful discussion of ethical issues, so, what does that
mean and why do we need that and what does that look like and what is it
that government may or may not do as contributing to that or helping set
it up or engage in that? all of which may be we don\'t know yet.

Here are some of the things the committee talked about in terms of what
to think about and why we thought about that and what helped in making
that decision, things to think through. This is why we put it on in the
paper to begin with and what we need to think about to move the ball
forward.

It\'s awfully hard to have an acceptable bullet without actually having
a conversation. Then we can come back and actually find the right way we
want to entitle it, but that\'s where I think we need \-- at some point
we need to have that conversation and we\'re not \-- to me, we\'re not
quite prepared to have it and yet rehashing what it means. We\'re
actually kind of are revving up our engines and at some point we need to
actually engage on that.

Michael, we have you and then Pat I think was next and then Carol.

DR. ENGLER: Somehow I think I\'m kind of on Jim\'s page here. The animal
health and welfare bullets seem to be under safety for me. I\'m having
trouble with the ethical considerations also. And I\'m struck by the
fact that most of the producer groups don\'t use welfare as a term
anymore. We could talk about animal care because we\'re talking about
issues like cruelty and abuse and things like this and proper husbandry,
et cetera.

However, I think in the GM realm or GE realm maybe welfare is
appropriate because we\'re not talking about typical animals. We\'re
talking about animals that have been engineered to be different than
what we\'ve bred over all the eons so maybe there will be a genetically
engineered animal that is no longer adaptable to its normal environment,
has to be grown in a barn, now for a very important reason possibly, but
so, I think, you know, in this particular case, you know, we should talk
about welfare under the ethical bullet; whether or not you\'ve created
an animal that\'s not going to have maybe, and I use this advisably, the
quality of life intended by the Maker, but I think that animal health is
a safety issue. It\'s safety of animals and care would be under that
bullet.

DR. VAN EENENNAAM: I think the welfare, the ethical, the health and
safety, is that kind of what you\'re saying?

DR. ENGLER: Yeah, animal health and \--

MS. DILLEY: Safety and then animal welfare.

DR. ENGLER: Animal welfare right below. Care up above. But welfare and
the other one and no health down here.

MS. DILLEY: Pat?

DR. LAYTON: Okay. Two parts. I mean, to Michael. I think, one, is when
the animal that\'s genetically modified and the other is animals in
general?

DR. ENGLER: Correct.

DR. LAYTON: Okay. That\'s two things, I think. One way to look at it is
one of the animals has been genetically modified and the other is the
health and welfare of animals in general that aren\'t genetically
modified.

DR. ENGLER: Well, no. I mean, this alternates between modified so we
don\'t \-- we want to make sure that the modification \--

DR. LAYTON: You\'re saying all the other \--

DR. ENGLER: \-- is safe to the animal and I guess to other animals that
could come in contact with it.

DR. LAYTON: There was one concept I wanted to ask about was it goes to
what Daryl said. Daryl said let\'s not reinvent what we\'ve done for
plants so the question I think I have is when we talked about \-- I
think we\'ve talked about food safety determinations under plants. Is
there something different here that we\'re looking at for animals that
go beyond?

We\'ve said some statements about FDA and transparency and all of those
things under our plant document. So, I guess what I\'m asking, maybe we
need to just change out what it is there that\'s animal specifically if
somebody has ideas what that is because I\'m not sure I know exactly.
But I just thought that might clarify what food safety is under there.
Is it more than how FDA gets to GRAS or or how it gets to "no further
questions" or is it more than that that we\'re talking about under food
safety for animals?

MS. DILLEY: Greg, did you want to speak to that?

MR. JAFFE: Yeah. I think that the comparator is not genetically
engineered plants versus genetically animals. Genetically engineered
animals compared to just non-genetically engineered animals, so, we
don\'t want any animal on the market unless it had some level of safety.
I think it would be safe to say we don\'t use any \-- we take care of
the animal under food safety but the question is what are the food
safety issues regarding the genetically engineered animal, the more
important term.

So, I\'m not a big fan of Daryl\'s distinction there because I think the
comparator means if a company imports, yeah, we check all imports to
make sure it\'s not diseases or *Salmonella* or things like that. The
question is, is there something that has to be checked for the
genetically engineered animal? I don\'t think we should be reinventing
talking \-- we\'re talking about food safety and we\'re not talking
about all the features that go along with making sure the beef and steak
is safe to eat.

We\'re talking about \-- here we\'re talking about the specific issues
of safety regarding a genetically engineered animal.

DR. LAYTON: And what are those?

MR. JAFFE: We\'ve added new protein; we\'ve added new DNA so how does
that change the nutritional quality of that food or what is the
expression of that new protein? You know, those are the issues.

DR. CARDINEAU: That\'s identical to the genetically modified plants.
It\'s exactly the same argument that we made for genetically modified
plants.

DR. VAN EENENNAAM: Can I clarify this? Daryl\'s point was not that we
should make a comparison between GE animals or GE plants for the food
safety. Are there different issues when looking at GE animals than when
we had GE plants, looking at the same issues so you\'re not comparing it
to each other? What issues are distinctly unique to transgenic animals
that weren\'t distinct or weren\'t a part of the transgenic plant
discussion and, so, with regard to the safety determination, all those
issues you just raised, Greg, will absolutely be true in the case of
animals.

But what\'s different about animals that would be unique in that
discussion?

DR. LAYTON: Thank you, Alison. You said what I was trying to think of.

MS. DILLEY: Let me get Carol, then Jamie, and then Daryl.

MS. TUCKER-FOREMAN: I want to know, is another one in that discussion if
Greg wants to respond on that, I\'ve got another issue that I want to
raise, but I didn\'t understand Daryl was suggesting that we not discuss
these things because we\'ve already discussed them under plants.

DR. LAYTON: I think he was just trying to say, what\'s specific to
animals? and so that was what I was trying to figure out what was
different about animals.

MS. DILLEY: Daryl, are they putting the right words in your mouth?

DR. BUSS: I was resorting these two categories, one of which there is
substantial overlap in my mind with plants. The differences, I mean, I
appreciate, you know, the distinction. Even with segregation, for
example, there are a lot of similarities. And then point out as a
separate classification that we see it as being much more substantial
difference pertaining to animals as per the plants.

MS. DILLEY: And that\'s the difference between animals and plants sort
of thing. You\'re taking that one to the next level. Carol.

MS. TUCKER-FOREMAN: I want to let Greg finish his point if I may before
I raise mine.

MS. DILLEY: Yes, definitely. Go ahead.

MR. JAFFE: I guess whether \-- I guess I still think that \-- I don\'t
think how get genetically \-- food safety in genetically engineered
foods or plants are particularly good in the Federal Government so just
I\'m saying what we\'ve got here is that we do the same thing for
animals I don\'t think is satisfactory I guess I\'m saying. And, so, I
still think that to say we want to concentrate only on the things that
are unique to transgenic animals that aren\'t involved with transgenic
crops to me is not the message I want to provide to the government or to
the Secretary because I still think what we should be doing is
identifying the key issues that are going to come up in bringing one of
these transgenic animals to market and I still think food safety is the
number one issue.

I think it\'s safe to say that \-- and animals that aren\'t in crops\--
I think if you don\'t get over that food safety you don\'t get to the
ethical or some of these other hurdles, so, it seemed like it was
suggesting that we didn\'t need to talk about these other ones because
they\'re the same, they\'re repetitive of things that we talked about
with crops, I don\'t agree with that.

I guess I think they do need to be talked about because I think they
still are to a large sense the driving factors about whether or not
these products will make it to market or not.

DR. LAYTON: But can we go back and refer to the issues that we\'ve
pulled out and refer back to them or even use words we\'ve used before
rather than having to re-debate the issue? That was my point. Have we
articulated the issues in our issue document that we still feel are
prevalent here and that we can even repeat if we want to, but did we
already hash it out? I think that\'s where my question was going and
then what do we need to add to it because we did tackle it.

MR. JAFFE: I think I\'m not sure what we wrote but we didn\'t write very
much on food safety in the end in the other report. And I think animals
are very different and I think you\'re eating the steak. You are eating
the protein, you\'re eating the animal yourself. We\'ve learned, looking
at the GE crops, you\'re eating some processed oil or some other thing.
I think people are going to be thinking about it differently. Maybe
you\'re eating the transgenic fish yourself than you are eating, you
know, the corn syrup or the corn in your soda can.

So, I do think to our \--

MS. DILLEY: Well, it\'s easy if we do that because I don\'t we have to
make decisions we can do it this way or we can\'t do it that way. It may
be that the committee has deliberated on food safety at the plant level
and we can \-- if you want to see that refer to X, but we\'re going to
talk about it, because it\'s coming up on their transgenic animals,
here\'s what we have to say about transgenic animal products and move
on.

I mean, it may be that we cite those reports and doesn\'t require more
discussion. It may be we cite the report and modify the transgenic
animal. It may be that we have to have a whole new discussion. So, I
think those are all fine. I don\'t think we could make a black or white
decision. That to me is kind of more procedural, yes, we need to go back
and reconfigure the report and we may want to elaborate and it\'s just
going to vary depending on the topic.

DR. LAYTON: Yes, I would say that. I just want to make sure that we
don\'t ignore what we\'ve already done. We will spend too much time on
it.

MS. DILLEY: Carol and Jamie.

DR. CARDINEAU: I have a comment related to this. Can I make it first, is
that all right?

MS. DILLEY: Go ahead.

DR. CARDINEAU: It seems to me that the food safety issues and the
environmental impact issues for transgenic plants and transgenic animals
are really very similar. I mean, foreign protein escape, what happens if
it gets into where it\'s not supposed to be, and so it\'s a very, very,
very similar things.

The major difference from my perspective is that we\'re talking about
plants and we\'re talking about sentient beings. Animals are sentient
beings. We think of them as feeling and I think that goes back to the
issue that Mardi raised before and it comes back to the ethical
language. What I got from Daryl was Daryl was saying a lot of these same
issues exist with transgenic plants and transgenic animals with regard
to food safety and environmental impact and so forth, but animals are
animals and so we have a separate set of issues that we may not have
thought about too much with regard to plants.

I don\'t think anybody\'s worried about it if we transform a plant if
we\'re going to hurt the plant. At least I don\'t think that issue\'s
been raised in my experience. But there is the concern you might hurt
the animal or what the overall impact will be on the animal and that
goes back to this welfare issue and the critical difference in my mind
is plants versus sentient beings.

And I don\'t know if that\'s where you were going or not, Daryl, but
that I think is what we can make a statement that many of these same
issues related to transgenic plants with regard to food safety and
environmental impact are the same issues that we\'re going to see with
transgenic animals, but there are another set of issues because of the
fact that they are animals.

MS. DILLEY: Okay. Carol and then Jamie.

MS. TUCKER-FOREMAN: In fact, there are issues that are similar between
plants and animals, that I would say is agreeable. I\'m not prepared to
suggest that we don\'t need to discuss them because I, for one, am not
happy with the way that the government has chosen to address and I think
the industry has suffered a lot of trouble because the obscure way in
which government chose to address plants.

But in fact, Guy, you\'re going exactly to the point that I wanted to
raise which is there an additional issue with regard to animals and that
is that you\'re altering a sentient being, and some proposals go way
beyond making something more tender. You talk about a wide variety of
issues that have measured impact, not just on the animals, but I think
they are \-- it goes beyond animal welfare and making decisions to alter
the animals in a variety of ways that go beyond the food chain to
production of organs for human transplant to things that I can\'t even
imagine say a lot about how we think of ourselves as human beings and
what our place in the spectrum of animals is and that it clearly opens
the door to creating transgenic humans, making basic alterations in
humans.

Cloning raises the issue. Cloning, nobody likes to think about that, but
it is the same technology and so it has to be considered. So, those are
the issues that I think have to be discussed as ethical issues. No
matter what we think about it they will be discussed.

Then there will have to be regulatory issues although government has
made a lot of decisions about regulatory frameworks for human bioethics,
about human genetic engineering. It seems to me unreasonable to say,
yes, we can regulate this completely and yet it\'s based on ethical
concerns and that it is not acceptable at all to think about the ethical
concerns raised in an engineering of other animals.

But it seems to me on the other side that is valuable to have an element
that provides an organized mechanism for the public discussion of the
issues that are there. And Health and Human Services has authority under
the Public Health Service Act to set up advisory committees to talk
about bioethics and genetics. They could, as far as Health and Human
Services, create an advisory committee under this existing authority to
discuss \--

MS. DILLEY: Now we\'re getting into the weeds.

MS. TUCKER-FOREMAN: I know, but I have to go to it because everybody\'s
saying well we\'ve got to regulate and I want to say that there are
mechanisms to use governments. They have an organized discussion as
opposed to a regulation or if you wanted not to go all the way to
regulation, but it is an element of governments that it is an
appropriate element of government.

We can do it there. We\'ve got a national advisory committee on
bioethics which has no regulatory authority but it is an organized
governmental mechanism for discussion of human genetic engineering.

I think it\'s appropriate to have governments that would discuss these
issues. I know we don\'t want to get into the weeds, but without talking
about what those mechanisms are the assumption here on everybody\'s part
is that we\'re suggesting that FDA made decisions based on somebody\'s
judgment of what\'s ethical.

MS. DILLEY: Well, I don\'t think \-- my challenge is that we\'ve got a
placeholder for ethical discussions and how deeply we need to go into
what it is you mean without actually having a full conversation. We kind
of dip into it and go a little further and then we kind of \-- we\'re
trying to make sure we\'ve got our categories and then we need to
develop a work plan from that.

We need a lot of discussion around meaningful discussion. We\'ve got
down here provision of forum for meaningful discussion. Many elements of
which you mentioned are relevant. I mean, it\'s not just for regulatory
purposes necessarily. There are all sorts of reasons for this.

MS. TUCKER-FOREMAN: Because this is the one that has been \-- the
discussions in this group and in the discussions that people in this
group largely participate in these are things that are simply not
discussed beyond the statement generally of we don\'t want FDA making
ethical decisions. It\'s decisions based on somebody\'s notion of
what\'s ethical. I get mad every time FDA does that, but it doesn\'t
mean it shouldn\'t be part of the human element.

MS. DILLEY: I think your point is that I\'m hearing is our other topic.
I think the question to the committee in my mind is you need to figure
out how to have that conversation to get into more of the next level of
the conversation; why do we want that; just like why do we want \-- what
do we mean by procurement and consumer branding issues and why is that
important?

MS. TUCKER-FOREMAN: You can say that I wasn\'t prepared to leave it as a
placeholder any longer. I wanted to make a statement about that.

MS. DILLEY: I understand that, Carol, but sure, just as Greg doesn\'t
want a placeholder just on key safety issues, and that\'s what we\'re
trying to figure out is can we \-- do we have the list of things that
people don\'t want as just placeholders and we actually need to have a
conversation about them and then I think the next run at this is how do
we have that conversation; how do we sort through what we mean by a
meaningful discussion so that it\'s not your ethics versus my ethics but
it\'s, you know, for what purposes and how we weigh the mechanisms
potentially?

There\'s lots of different ways to set up a meaningful forum. There are
other models. Michael\'s sent around something on the European, I can\'t
remember what it was, but you\'re right, we can\'t just keep it as a
placeholder and I don\'t think that\'s the intent of the committee, but
I want to get the list here so we know. We\'ve got 2.5 meetings, how are
we going to do this.

MS. TUCKER-FOREMAN: I had heard three people say that ethics didn\'t
belong in this list.

MS. DILLEY: I didn\'t hear that at all. I heard putting it around a
different spot on the list but I didn\'t hear anybody say take it off.

DR. LAYTON: There were different types of ethical places.

DR. CARDINEAU: I don\'t think from a statutory perspective FDA doesn\'t
make decisions based on ethics or economics. They make their decision
based on safety.

MS. TUCKER-FOREMAN: Unfortunately they frequently make them based on
somebody\'s notion of ethics and I will run you through a list of those.
I\'m one of the people who objects to them doing that but I\'m not
suggesting that that be done but that doesn\'t mean that I don\'t think
that it has to be discussed in some government context.

MS. DILLEY: Jamie has had his card up for like 45 minutes. He\'s been
patient. Let him have his say and hopefully we haven\'t run past your
point.

DR. JONKER: No, I think we\'re down to where we were going. The issues
of ethics and morals are personal and I think we need to tread carefully
on it. Something like consumer traits, mandatory labeling versus
non-mandatory labeling, moral and ethics issues. My thought is that we
should actually pool ethical and marketing issues into a bushel of
socioeconomic consideration such as consumer marketing and animal
well-being, things like that.

I\'m very concerned that we\'re going to go down a line of trying to
make the decision what is moral and ethical in transgenic animals that I
don\'t think that any of us are qualified to make that on a national
basis.

MS. DILLEY: You mean we the committee?

DR. JONKER: We the committee. I\'d be very cautious about how we
approach that and I want to take care in how we frame it because they
are such personal decisions.

MS. DILLEY: I don\'t think there would be any disagreement with what you
just said. It needs to be framed very carefully and the question is, how
do you frame it successfully and for what purposes? and that would be
the conversation and it may be under a whole cluster of socio-economic
issues. I don\'t know.

I mean, again, that\'s a conversation that we need to have, so, you
know, I keep putting it on there and making sure people understand that
it\'s on there and need to be careful about how we set that up and the
need to have a conversation, but actually try to have the conversation
at this point in time because we have other things on the list too that
we want to make sure we have on there and then set up a good work plan
to do that.

So, I think Nancy was next and Jim. Okay.

DR. ROBL: I guess my only comment is that we do \-- we are intending to
move into those discussions. Should we basically say that the topics are
\-- we can always come back and make a change, but we\'ve got the list
of topics and we should actually enter into having those kinds of
discussions.

MS. DILLEY: We do and I think that\'s fine as long as no one has
anything repeated, x, y, and z on there and if we don\'t have any of
those x, y, and z\'s then, yes, I think we can proceed and say, okay,
we\'ve got a list and let\'s try and take a run at developing a work
plan and have those conversations and some of which you can organize.

DR. ROBL: I was thinking we should finish that up in the next 15
minutes.

MS. DILLEY: You mean actually have the conversation in the next 15
minutes? Nancy.

MS. BRYSON: I think the committee would do better once we actually get
into the substance. And I think that doesn\'t mean that we can\'t add
something as a result of the discussion on ethical principles or food
safety or something and say, oh, my God, here\'s a topic and I never
thought of it, so, let\'s put it on at this point.

MS. DILLEY: Yeah, really miss something.

DR. LAYTON: I don\'t think I heard anybody say take something off.
We\'ve moved the chairs around but I\'m not sure we had anybody say add
something either other than throw out the road.

DR. CARDINEAU: We took off risk-benefits.

DR. LAYTON: We didn\'t take off risk. There were some things with risk
assessment.

DR. CARDINEAU: And I tried to add risks.

DR. LAYTON: We may have taken that risk-benefit analysis off including
evaluation of alternatives. I thought that was part of risk. We just
moved it down to marketing.

MS. DILLEY: Okay. So there\'s nothing else. Other elements has moved
down to general characteristics. See if there\'s anything else under
there. Again, we can come back to this. Yes?

MR. CORZINE: Is the intent now where we have marketing is that going to
jump to where we have marketing on page 3 of the draft? So I understand
what we\'re doing. Where you have marketing under 3.

MS. DILLEY: You know I have no idea. We need to take this list and kind
of reshuffle the outline.

MR. CORZINE: So if you want to go at the moment. I mean, we\'ve got the
three main things under safety first.

MS. DILLEY: Yeah, yeah.

DR. SCHECHTMAN: I think we will need to reconfigure I think the sort of
remaining questions before we can finish the reconfiguration. The other
pieces that are in this big Roman Numeral II topic which we haven\'t
dwelled on today yet so far, which is to say the marketing piece,
without figuring out where benefits are going to go or specifically to
what extent those are in there.

The other pieces that are currently listed there and the pieces that are
listed under little IV, Other Elements, are those the other pieces that
people think belong there at least in the 200,000 foot level so that we
can jump into the weeds or a little close?

MS. DILLEY: I don\'t know. I heard you say other elements I understood
got moved down to a new C, General Characteristics of Governance.

DR. SCHECHTMAN: I thought General Characteristics of Governance I looked
for in the Transparency, third one in.

MS. TUCKER-FOREMAN: The coordination would be that general.

MR. JAFFE: Education.

MS. DILLEY: Right.

MS. TUCKER-FOREMAN: Education I\'m not sure about, but tracking system
strikes me is \--

DR. CARDINEAU: Are we talking about tracking again? I\'m going to go
back to my question about where it currently is. We\'re talking about
tracking progeny? Are we just tracking \--

MS. DILLEY: That\'s a question for the group. I mean, we getting into
that right now, I think that\'s a very good question. That was a very
good question and I don\'t think there\'s an answer to that at this
point.

DR. LAYTON: And education, are we talking \-- footnote 7 says is
producer, supplier, consumers, society, environment. It seems that\'s
under marketing.

MS. WHELAN: Could we not try to put this into those i, ii, iii and can
we not do that? We move these things around and when we\'re discussing
them it\'s not clear whether \--

MS. DILLEY: Where they go.

MS. WHELAN: We don\'t take them off. We just keep moving it around. Take
those things off and just leave a big list and then we can renumber them
when we\'re finished.

DR. LAYTON: Alphabetical.

MS. DILLEY: Okay. So \--

(Discussion off the record)

MS. TUCKER-FOREMAN: I know we don\'t want to go into this anymore
because we got through a round so that under ethical right now the only
thing under there is animal welfare and, you know, \--

MS. DILLEY: I\'ve just got to sit down with all the conversation and
take an accounting of where we are. So what we need to do is come back
either later this afternoon or tomorrow with, okay, so how do we develop
our \-- what are the elements that needs to be discussed after you set
up the conversation? and get to the next level of deliberations.

So, why don\'t we take a \-- can we take our break a little early and
then come back with some public comment?

DR. SCHECHTMAN: We have to have the public comments \--

MS. DILLEY: Right after.

DR. SCHECHTMAN: \-- when you said you were going to.

MS. DILLEY: Okay.

DR. LAYTON: Could we have a 25 minute break?

DR. SCHECHTMAN: You can have a 25 minute break.

MS. DILLEY: I\'d like to have a 25 minute break.

(Whereupon, a brief recess was taken)

DR. SCHECHTMAN: Okay. Now is the time for public comment, people. Let me
just remind committee members that this is time where we hear comments
from the public for a maximum of five minutes. Those comments are
entered into the official record of the committee. It\'s not a time for
discussion with commentors. We are rather soliciting public comment and
having those entered into the public record. So, with that, let me turn
to Pat.

DR. LAYTON: Okay. I just heard a buzz. Okay. I\'m just checking. Today
we have for public comment Dr. Barbara Glenn. Barbara is with BIO, which
is the Biotechnology Industry Organization. Barbara, welcome to our
meeting and we appreciate your making public comment.

DR. GLEN: Good afternoon, everybody.

(Discussion off the record)

DR. GLEN: Thank you very much for allowing me to make my remarks. My
name is Dr. Barbara Glenn. I\'m managing Director of Animal
Biotechnology at the Biotechnology Industry Organization. BIO is the
world\'s largest international trade organization for the biotech
industry and we have a subscription of over 1,200 members and we serve
the industry with regard to human health, food and agriculture, and
industrial and environmental uses of biotechnology so I just thought
I\'d start with that brief comment so you know from where I come.

BIO and its members engaged in animal biotechnology support of a strong
federal regulatory system to oversee the safe and responsible
development of all genetically engineered animals and the products
derived from them. Such a regulatory system is critical to maximize
public acceptance, to assure safety, and, indeed, to facilitate trade.

Regarding USDA\'s authority, BIO and its members do not anticipate that
the development of GE animals has significant negative animal health or
environmental impact. In fact, we expect that genetic engineering will
improve animal health, well-being, and welfare and reduce the animal\'s
environmental impact.

Nevertheless, we certainly believe that the examination of these
potential impacts in a transparent way may help to gain public
acceptance of these animals throughout the United States and
internationally. USDA\'s experience and expertise in regulation of
animals and animal products is long-standing and encompasses several
areas impacting GE animals.

As you know, the USDA currently regulates the welfare of animals used in
biotechnology research as well as animal biologics and GE insects. Under
its authority to regulate central risks to animal and plant health USDA
may play an important part in examining and regulating any potential
animal health and environmental concerns raised by transgenes in
animals.

In addition, USDA would regulate, of course, the safety of meat,
poultry, and eggs produced from GE animals or their progeny. Appropriate
regulatory oversight should be given to all GE animals, including
insects, livestock, and companion and other animals. BIO supports the
new animal drug process of the Food, Drug, and Cosmetics Act as a
framework for the regulation of GE animals by the Food and Drug
Administration.

To protect public health and safety and avoid duplicitous or
over-burdensome regulations, oversight among USDA and FDA should be
coordinated. Under the terms of possibly a Memorandum of Understanding,
particularly one that acknowledges the need for flexibility over time,
USDA could coordinate its regulatory efforts with FDA to the maximum
extent possible to minimize the regulatory burden on product developers.

The plans and applications of these technologies are rapidly moving
forward. Successful commercialization of these applications will depend
however on public acceptance and competency and technology safety not
only to the animals but to the human consumers of the products that are
produced from these animals and to the environment as well as indeed the
responsible stewardship of the animals that are involved in this
technology.

Therefore, while BIO supports the committee\'s work, we applaud you for
moving forward on this project and we urge you to proceed with your work
in an expeditious manner. That concludes my comments, Mr. Chairman. Mrs.
Chairman. Excuse me, Patricia. Thank you very much for the opportunity.

DR. LAYTON: Thank you.

DR. SCHECHTMAN: Thank you very much.

DR. LAYTON: Checking the audience one more time. No other commentors and
with that I will turn it back over to \-- the meeting back over to Abby.

MS. DILLEY: Yes. During the 25 minute break, I hadn\'t come up with a
new outline. I wish I had. But at this point I think it would be helpful
to have some more discussion around setting up the different thoughts
that we have, the different items that we have. Again, not to
reconfigure again, but to actually be able to engage in some discussion.
Some of it needs more setup than others.

We talked about the safety piece of it and we have food safety
determination and animal health and care and then environmental impact
evaluation I think under that. Yeah, animal health and care,
environmental impact evaluation.

So, maybe to actually look at some of those pieces and take another cut
of those topics might be \-- to me would be a helpful way to start and
taking notes at the top of the list may be a good way of getting into
hopefully a rhythm of what we mean to go to the next level of the
conversation and flush that out a little bit more.

So, the safety piece of it in terms of what did you intend to identify
as government issues, taking that first category and sorting that
through a little bit more I think would be helpful. And then we could
see if we could take a couple of those categories and do the same and
come back to the ethical piece and trying to set that up.

So, we could take maybe that first because I don\'t have a good feel for
that right now in terms of what are we looking for to bring that to \--
again, it\'s not so much that we\'re making a safety determination, but
what issues we want to put before as a committee government to think
about and looking at some of those pieces.

So, identify food safety issues, animal health and care, and
environmental impact evaluations will be helpful to put a little bit
more around those topics.

DR. LAYTON: Well, under food safety we always talked about a transparent
open process, right?

MS. TUCKER-FOREMAN: Mandatory pre-market.

DR. LAYTON: Rather than "no further question." Right.

MS. DILLEY: First of all, we\'re looking for safety if it\'s for a
product that\'s intended for food or feed we\'re looking for safety of
that product, right? I mean, that\'s kind of the bottom line so it makes
sense.

Are there any other pieces of that? There\'s voluntary, there\'s
mandatory, there\'s other dimensions of that statement. Are we looking
for effective on food safety?

DR. LAYTON: How about effective?

MS. TUCKER-FOREMAN: I don\'t understand.

MS. DILLEY: Animals genetically engineered for food and feed uses are
safe.

DR. LAYTON: As opposed to other animals.

MS. DILLEY: Right?

MR. CORZINE: It\'s already under food safety determination.

MS. DILLEY: Kind of give it to me in shorthand. I\'m trying to just get
a few useful sentences. I know how hard it is at the end of a day.
Alison.

DR. VAN EENENNAAM: Are we looking here at how things differ? So, are we
going to list everything that you go to watch out for the protein being
\-- you know, everything we\'ve done. I guess that gets back to that
discussion we had earlier. Are we looking for specific things here that
will be different? and I think the mandatory is different.

MS. DILLEY: Right. Yes, you\'re right. What are we looking for as far as
looking at some of the other reports? I think the one that we started on
food safety issues a little bit more with Opportunities in Agriculture
and Biotechnologies, the effect it would have when you talk about
animals and plants and the one thing is not necessarily to re-discuss
what we\'ve already discussed but maybe one of our assignments could be
to go back and refresh our memories on what we\'ve already said so that
we can either reference that in our report and not go down that path and
then add to whatever other comments, new topics, et cetera that would
need to come under this and have that discussion.

Jamie, did you want to ask \--

DR. JONKER: One thing is we may need to look at how food safety
determination fits in the current context of the CODEX and what would be
a protocol for protecting risk assessment of our DNA animals.

MS. DILLEY: So, things pop up in my mind regarding CODEX and we know,
you know, just like we\'ve already said in terms of contextual piece we
know what happens in government as well as more globally, right, so,
that CODEX piece fits into that.

But then what we talked about quite a bit was the harmonization and how
other countries import and export meat and, again, kind of tag so we
need to get our arms around what are those different dimensions of it,
whether they\'re discussions we\'ve already had and need to reference
those or is there something new that we need to talk about, some of the
new things.

It\'s not just the international arena in CODEX. I don\'t know how we
want to reference that but we need to at least figure out how we want to
make note of that. So, you know, again, what I think we need to do is go
back to what we\'ve got. I don\'t know if we\'ve actually addressed the
food safety issues specific to animals. We may be jogging our memories,
you know, what was already talked about, some additional topics.

Greg, yes?

MR. JAFFE: I don\'t mind going back over what we did in the past because
I\'m one of those people who\'s been at the table since the beginning,
but I would say the majority of people here haven\'t been involved in
the previous reports so the report that was done by the people on the
committee at the time \--

MS. DILLEY: I\'m not saying that should drive it either.

MR. JAFFE: \-- so that\'s one of the things because actually most of the
report was done, I think, with the exception of Daryl.

MS. DILLEY: Okay. So what are the issues?

MR. JAFFE: We could refer back to them.

DR. LAYTON: Here\'s what we\'ve done in the other document, what else do
we add or is there a different outcome of what the issue is?

MR. JAFFE: I think all I\'m saying is a lot of people here did not have
a say in what we said. You did say what should we add. It doesn\'t mean
you may want to repeat what we said if there\'s agreement in it.

MS. DILLEY: So not having the benefit of having gone back in past
documents. Going back to the conversation with Daryl, but what issues
would people like to see under food safety? We have gone down that path
and we wondered well, what have we already said and we may have said
what we already said. We can go through it and decide whether it was
what we said later. What would people like to see and then we talked
about the mandatory, voluntary. We talked about the \--

MS. TUCKER-FOREMAN: Mandatory pre-market.

MS. DILLEY: Okay. So, that\'s kind of a dimension. Is it an approval or
is it a \-- so that\'s one piece of it. I\'m not saying you can answer
that question. I\'m just saying that\'s one of the issues that the
government needs to address whether it\'s an approval or not. Yeah,
it\'s to declare it safe or not safe.

What other dimensions of safety, whether it\'s animal, is there anything
else under the food safety piece of this that you want to flesh out?

DR. LAYTON: We talked about transparency about safety determination.
Process issues.

MS. DILLEY: So anything else under food safety? Did you have something
on food safety?

DR. ROBL: Yeah. If, for example, a product is not a component of the
animal that\'s used for food is a mandatory pre-market determination
that the food is safe something that\'s necessary? In other words, is
this an across the board thing or is there something that \-- or maybe
we should just put as a bullet that there should be some consideration
about what the genetic modification actually is.

MS. DILLEY: So what is being determined as safe? Is that part of that
\--

DR. ROBL: For example, you could make a genetic modification that
doesn\'t alter any component that\'s actually consumed and so versus you
could make an alteration in a muscle protein. There would be different
kinds of modifications and I guess as an item simply to put down that
there should be some consideration as to what the genetic modification
is and its actual impact on the food item.

MS. DILLEY: Right. Okay.

DR. CARDINEAU: There\'s a differentiation between animals used to make
pharmaceuticals and milk, for example, that could eventually be
slaughtered and their meat products could be used because they would
never express the products in any other part of the body except in the
milk. Is that what you\'re thinking about?

I don\'t really think about those animals as food animals.

DR. ROBL: Actually, I wasn\'t thinking about that. I wasn\'t thinking of
anything in particular. That\'s a good example. I was just looking at it
saying, okay, when it comes to food safety and we\'re listing items to
consider, what are the items that you might consider?

MS. DILLEY: The other piece of that kind of links, Guy, your previous
\-- how far down, express kind of a generation do you review for safety,
I guess. I mean, that\'s another question.

DR. ROBL: Well, you can put on there that safety should be evaluated
both in parental line and offspring if it\'s the offspring that will be
consumed.

MS. DILLEY: I guess it\'s more the question so parental versus
offspring.

DR. CARDINEAU: It could affect the tracking which comes up later.

MS. DILLEY: Yes. Yes. Carol.

MS. TUCKER-FOREMAN: I just wondered how \-- do these go under animal
health and care, this sort of thing, because I thought these were being
discussed as elements of food safety determination.

MS. DILLEY: There will probably be some.

MS. TUCKER-FOREMAN: Because it seems to me that the determination that
the transgene actually has something to do with food safety was
something that would be considered during the course internally whether
the product is safe and so I wanted to bring that point up.

DR. ROBL: I agree.

MS. TUCKER-FOREMAN: Whether it applies to the original animal, the
progeny, the offspring, applies to progeny seems to me would be part of
food safety determination. If this is going to be many thousands of beef
I\'m not sure we would need to get into those kind of details if what
we\'re talking about is whether or not you want or don\'t want a
mandatory pre-market determination and I\'m not sure yet you have to go
into very much more at this point.

DR. ROBL: So, the top one there should not be a separate bullet but it
should be under food safety.

MS. TUCKER-FOREMAN: I\'m not sure that we need to say anything more than
\-- are we willing to have \-- do you want to go that deep on it is the
question.

DR. SCHECHTMAN: I think there might be a couple of other questions that
the committee might want to address that are at the same level as that
one that Carol is talking about.

MS. TUCKER-FOREMAN: That includes parental line and offspring and
harmonization.

MS. DILLEY: I envisioned it coming under the marketing piece.

DR. SCHECHTMAN: Just a couple of observations. One, the
parental-offspring thing might instead of going into that level of
detail, you might talk about and, you know, what the safety
determination actually goes to and the scope of the determination.

MS. TUCKER-FOREMAN: The scope of the determination, mandatory
pre-marketing determination, and the scope of that. Yeah, that sounds
reasonable.

DR. SCHECHTMAN: And the other point that I wanted to make along these
lines I forgot. You want to come back to me.

MS. DILLEY: Pat.

DR. LAYTON: I was going to ask is there a place here that we need to say
this animal and its progeny are not ever going to go to food and so
therefore it\'s going to follow x and then there\'s another side where
this animal can go to food or feed and it follows y so that, for
example, there would be a way that you could genetically engineer goats
so that they could produce a medicine in their milk, a protein in their
milk, that would allow you to allow those things to live, have its own
kind of welfare, et cetera, never to go to the food supply.

Is there some other way of ending their lives \--

MS. TUCKER-FOREMAN: They\'re sacrificed and buried.

DR. LAYTON: Right. So, where is that in this conversation? Is that an
equivalent and there\'s a process for food and there\'s a process for
non-food?

MR. SLOCUM: Yes.

DR. LAYTON: Okay.

MS. TUCKER-FOREMAN: I think an example of that would be under the new
animal drug application system. That is one of the things that you would
consider in that construct.

DR. LAYTON: So, at some point there\'s a decision that someone has to go
to to start with that says I\'m going to do this and I\'m going to do it
for non-food or I\'m going to do it and I\'m going to do it for food.
And that\'s a decision point, top-level, as they start a process.

MS. TUCKER-FOREMAN: Those are things under food safety. You know, we\'re
looking at the screen and I can\'t see. The board\'s there and there
seems to be things that would come under safety generally but under food
safety determination.

DR. ROBL: So the first two should come under food safety.

MS. TUCKER-FOREMAN: Yes, I think so.

DR. ROBL: Just take the top two bullets and move them under food safety
determination bullet.

DR. BUSS: Isn\'t food safety sort of implicitly staying in the food
chain?

DR. LAYTON: There\'s another chain that\'s non-food.

DR. ROBL: Well, but it is a number you have to specify. That\'s by
default. You don\'t do a food safety determination if you don\'t plan to
have it enter the food chain.

DR. LAYTON: Right, but that doesn\'t mean that USDA will have some kind
of regulatory. I mean, that doesn\'t mean that we have the issue of
governance over non-food things so I\'m just trying to make sure that
we\'re thinking of all the animals.

DR. ROBL: Right. But that\'s not food safety.

DR. LAYTON: Right. So the key is what do you call that safety issue.

DR. ROBL: You\'d probably go down to animal health and care or
environmental impact.

MR. JAFFE: I actually think it does come under the food safety
discussion because I look at this from the point of view of what are the
\-- again, I\'m looking for what are the issues that the government
should be involved in in this product going to commercialization as it
moves down the line to try to meet commercial product? and, to me, the
first issue is safety in the food supply, and, so, the consumer wants to
know, the government, some independent body coming in and telling me as
a consumer that if I eat food from a transgenic animal it\'s going to be
safe, okay, and that\'s a pretty mandatory pre-market determination
issue.

But clearly, if there\'s going to be transgenic animals out there that
are food, transgenic food animals, meaning it\'s an animal I could eat
or could enter the food supply; if it\'s not entering the food supply my
one concern is it\'s not going in the food supply and that comes in, I
think, and, so, a determination to enter the food supply and part of
that is the stuff I\'m eating is safe or the stuff that\'s not is not
getting into the food supply.

And there are provisions for ensuring that, but I do think they go
together because you\'re talking about from the point of view a goat is
a goat and a cow is a cow and you say, well, I can separate it, but they
want to know, have the assurance it\'s been adequately separated.

So, I can see them sort of \-- I sort of agree with Carol. I mean, from
my past experience we\'ve got about three issues under safety. We\'ve
got, I don\'t know, six issues under \-- three or four issues under
commercial and marketing. We\'ve got three or four issues under ethical.
And I think we\'re talking about that in two paragraphs in each of these
issues in the report and so you\'re not going to get into all that
detail.

MS. DILLEY: It is, I agree. And you need to wonder what is in those
paragraphs. So, you\'re right. We get way down there, but we need to get
clear to know what\'s in the paragraphs.

MR. JAFFE: Right. I think you have more than what\'s already out there.

MS. DILLEY: We\'re trying to sort out what we don\'t want.

MR. JAFFE: Right, with that understanding.

MS. DILLEY: So, yeah. Jamie and then Michael.

DR. JONKER: I do think the harmonization product standards needs to be
in this part rather than in the marketing part because the harmonization
is really at the approval of the product at its stage rather than saying
we approved it, now we\'re going to try and harmonize what we said,
it\'s safe with this process that determines how we should get there on
an international market.

See what I was getting at there, the fact that \--

MS. DILLEY: Yes.

DR. JONKER: \-- you have to have a discussion before you get into the
marketplace rather than after it\'s at the marketplace.

MS. DILLEY: Yeah, okay.

DR. JONKER: And I think that\'s a subset under the mandatory pre-market
determination.

MS. DILLEY: Okay.

MS. TUCKER-FOREMAN: I want to raise an issue about that because we could
determine that it\'s not going to go into the international trade and
therefore our safety determination didn\'t have any impact on it.
That\'s only relevant if the marketing issue is it has to be something
that can go into the international trading system.

We have a determination that is contrary to the other \-- that is
consistent with hormones that Europe won\'t buy our hormone beef and
they pay a price for it. They made the distinction that they\'re going
to add a standard that\'s not consistent and it\'s a marketing decision,
not a safety decision.

MS. DILLEY: I think you guys are saying you think there\'s a little
issue here and it\'s \--

MS. TUCKER-FOREMAN: But it\'s not a safety issue.

MS. DILLEY: Right.

MS. TUCKER-FOREMAN: It\'s whether or not \-- you know \-- the safety
issues are what we use here.

MS. DILLEY: I see what you\'re saying.

MS. TUCKER-FOREMAN: If we want to sell it \--

DR. JONKER: CODEX is a safety issue. Whether or not you\'re the EU or
other nations want to use junk science as non-trade barriers is not
something that we should talk about. I think the CODEX issue needs to be
at the safety issue, not at the market issue level.

MS. DILLEY: Greg.

MR. JAFFE: I think it\'s different things. I mean, what CODEX is doing
is having \-- it\'s a procedure for determining safety. It\'s risk
assessment. They\'re doing a risk assessment. They\'re putting together
a risk assessment pathway.

DR. JONKER: As opposed to market access.

MR. JAFFE: Well, so, I mean, that\'s what they\'re putting together and
I think you\'re saying is that whoever is making the determination for
the U.S. should be looking to what the international standard is for how
to make that decision. CODEX doesn\'t tell you whether it\'s good or
not. They only tell you what\'s the data, what\'s the analysis to make
that determination. In the case of the EU, they interpret the
determination and not the techniques and the mechanisms to make the
determination.

What he\'s saying is we should be saying that our system should be as
good as the rest of the world and that.

MS. DILLEY: That\'s what you\'re saying? Okay. I\'m glad you clarified
that because I don\'t remember \--

MS. SULTON: Is it the assessment method?

MS. DILLEY: Standards. Yes. All right. So I have Michael, did you
remember what you forgot?

DR. SCHECHTMAN: Actually no.

MS. DILLEY: Carol.

DR. SCHECHTMAN: One other point and that is instead of being food safety
determination going to what Greg was saying you can have mandatory food
safety determination, pre-market determination underneath but the
overall topic as Greg was mentioning was safety in food products and I
wonder if that is heading \--

MS. TUCKER-FOREMAN: But first of all, the bullets seem to be organized,
but the consideration of what the genetic modification is and impact on
foods, again, I\'m not sure what that means.

DR. LAYTON: If it was to not have horns?

MS. TUCKER-FOREMAN: If it\'s to not have horns?

DR. LAYTON: Yes.

MS. TUCKER-FOREMAN: It seems to me that that would be \-- so that would
be one of the things that you would consider in making a safety \--
okay, understand.

DR. ROBL: I had made that comment with the argument that that would be a
bullet under the mandatory pre- market determination.

MS. TUCKER-FOREMAN: I heard you say that.

DR. ROBL: Yeah.

MS. DILLEY: So are we \--

DR. ROBL: On the provision for assurance I am not entirely clear on what
the logic, or what if I have a transgenic animal, what part of the
regulations that would prevent me from putting it into the food chain?
And the reason I ask that is because I don\'t know this for sure but it
sounds a lot like you\'re trying to say you have to prove to me that
you\'re not breaking the law which I don\'t think is probably a good
thing to do.

MS. DILLEY: What do you mean? You mean put some language around \--

DR. ROBL: A company that\'s making a transgenic animal has to prove to
the government that it\'s not letting those animals go into the food
chain. To me, if you want the animal, to me, the underlying regulation
is they don\'t go into the food chain and if they go into the food chain
by doing something wrong and I guess I don\'t think it\'s appropriate to
say to your company that you have to prove that you\'re not doing
something wrong.

MS. TUCKER-FOREMAN: What you might have showed the government is what
your mechanisms are for assuring that it doesn\'t go into the food
supply. This is not going into the food supply and here are the ways
I\'m keeping it out. That would be part of the safety determination, I
think. If you\'ve got a goat, you know, you\'re never going to put in
the food supply so what is it you\'re going to do with it to keep it
out.

MS. DILLEY: You\'re not breaking the law, it\'s kind of method, how are
you going to dispose of the animal.

DR. ROBL: I\'m trying to think of how that works in reality. From our
point of view, we do have tracking for every animal and we do know where
it goes. To actually have a regulation to have to prove to the
government that we\'re not doing something wrong does not seem an
appropriate way to regulate. In other words, prove to me that you
didn\'t park, you know, in an illegal parking zone this morning, that
kind of \--

MS. TUCKER-FOREMAN: Look at it as you had something that is a potential
risk that hasn\'t been determined to be safe and it\'s gotten into this
exception box and so you\'d have to show how you\'re set up for the
exception box how you\'re going to get rid of the animals to make sure
that it doesn\'t go into the food supply is the preventive health step
there that helps avoid having to go out and recall a whole bunch of meat
because uh-oh, one of those goats did get in the food supply.

So I think it is certainly well within the regulatory structure that
both FDA and USDA have used in the past to say, how are you going to
ensure that it doesn\'t get there? USDA, for example, as you get meat
that is contaminated with the *E. coli* 0157:H7 it goes into a big bin
that says rejected and you have to show the government what you\'re
going to do with that to make sure that that rejected batch doesn\'t get
back into the food supply.

MS. DILLEY: I think I understand what you\'re saying. So, Carol looked
at ways of doing kind of one look of provisions for assurance and
you\'re looking at what do we really mean and what are we trying to
establish. What\'s it going to look like in the provisions of assurance?

DR. ROBL: I think I\'m looking at a slightly different perspective and I
would give the other perspective by saying, okay, USDA goes to a farmer
and says prove to me that you did not put any cows into the food chain
that were *E. coli*-contaminated today.

MS. TUCKER-FOREMAN: They don\'t go to the farm. They\'re already
searched at the slaughterhouse door and they regulate everything that
goes on in the slaughterhouse including disposing of beef that was
produced that the inspector rejected is not going to into the food
supply after the inspector goes around the corner.

MS. DILLEY: So can we pick up a couple of cards because people have
their cards up. Daryl, Steven, Guy, and Stephanie.

DR. BUSS: At the moment, the last item under marketing, channeling and
segregation piece, right now we have mechanisms for keeping the animals
out of the food chain and we can say mechanisms for channeling the
segregation for animals intended/not intended for the food chain as
opposed to having it under marketing.

DR. SCHECHTMAN: I think channeling, I think in the plant context
channeling is, no one\'s ever claimed that that\'s a 100 percent
accurate system. If I can just jump in from my perspective. If you have
a mandatory pre-market approval system product you\'re going to undergo
review and there would be some sort of provision in whatever that legal
structure was that says these things cannot enter the food supply until
such time as the review had been satisfactorily completed and you will
need to tell us what your system is to ensure that. We\'re not intending
to check every animal during that time but if something should happen
you\'re going to need to be able to account to us what happened to all
the animals.

MS. TUCKER-FOREMAN: I think the concern is we\'re talking about
excluding a class from the safety provisions. It\'s excluding this class
on the grounds that it is not going into the food supply. Therefore, you
got to show how these have met the requirements.

DR. BUSS: Isn\'t that a pre-approved assumption? I mean, it seems to me
that if you were looking at animals in the future you might well be
looking at two different groups of transgenic, one of which might impact
the intended for the food supply and many more than not.

It seems to me now we\'re saying it\'s all where there will no other
class other than not accepted into the food supply the way it\'s now
reading.

DR. SCHECHTMAN: I was only talking about "not accepted until such time."
There are two non-accepted classes. There\'s the non-accepted class
until such time as they\'ve completed their food safety review and
there\'s the not intended for and therefore not accepted. Is that a

fair \--

DR. LAYTON: That was my question. There could be a class of animals that
are not intended for food and another accepted for the food supply. Then
there could be all those animals that we are doing our experiments with
or have all the work done until it gets market acceptance and if they
die in that time period what happens to them because it\'s not accepted
as safe yet you\'re not going to find them in there.

DR. SCHECHTMAN: No, not if they die.

MS. TUCKER-FOREMAN: There\'s a risk it will go into the food supply.

DR. LAYTON: Right. So what are you going to do with it?

MS. TUCKER-FOREMAN: If it\'s an animal that is capable of going into the
food supply and if it looks like goat, it walks like a goat, it is a
goat, except it has a DNA change that let\'s just say we\'re excluding
how does somebody who doesn\'t know what that is makes sure it doesn\'t
go into the food supply? You know, if it looks like food, you got to
have a way to make sure that doesn\'t get in the food supply.

MS. DILLEY: Guy and then Stephanie.

DR. CARDINEAU: I\'ve got to agree with Daryl. Since you meant to keep
the animals out of the food chain and we\'re talking about keeping any
animals out of the food chain and I don\'t think that\'s what we\'re
trying to say here.

MS. DILLEY: That\'s not what we\'re saying.

DR. CARDINEAU: Isn\'t there a mechanism for monitoring the
presence/absence of these animals into the food chain?

DR. LAYTON: It\'s non-food GM.

DR. CARDINEAU: But it doesn\'t say.

DR. LAYTON: Oh, here. Is that better?

DR. CARDINEAU: Yes, I would be happier with that than the way it was
written before because the way it was written before you can\'t have any
GM animals.

MS. DILLEY: That\'s not the intent. It just didn\'t have the right setup
there. Stephanie, Greg, Alison, and then \--

MS. WHELAN: One thing I want to comment on the earlier conversation
someone was talking about provisions for shrimp and really that sounds
like something like HACCP so that there are critical control points. I
mean, you do the critical control points in the HACCP provisions we have
in this area. I mean, I think that\'s bound to change in ways that could
progress.

MS. DILLEY: Greg and then Alison.

MR. JAFFE: I think Alison was before me.

MS. DILLEY: Was she? Okay. I\'m glad you\'re monitoring yourself.

DR. VAN EENENNAAM: Okay. This has already been taken care of right now,
but the mechanisms for keeping pre-regulatory animals out of the food
supply, yeah, pre-approval. For everybody has to do that. And then one
of the issues that came up with the pigs is what about non-transgenic
pigs and animals that are housed with them and, you know, what is a
transgenic animal from the term of regulatory, animals that are housed
with transgenic animals or transgenic animals themselves, non-tapes,
mothers, you know, what\'s the cutoff?

DR. LAYTON: I think it excludes a mother.

MS. TUCKER-FOREMAN: The system is you\'ve got to have assurances that
there\'s a mechanism for keeping the non-food animal out but the mother
would not fall into that category.

DR. VAN EENENNAAM: I\'m just putting that out there. You need to \--

MS. DILLEY: Greg, Adrian, and then Michael. Adrian?

DR. POLANSKY: It seems to me that we\'re talking about is recordkeeping,
tracking, and all of that and disposition. Isn\'t that what we\'re
talking about? So, it\'s verified and audited basically and determined.
To me, that\'s what it\'s talking about. That\'s all I had.

MS. DILLEY: Michael?

MR. ENGLER: Yes. Just to muddy the water further you could imagine an
animal that\'s approved, say, the cow or the goat, but the milk could be
approved for consumption but not the animal.

MS. TUCKER-FOREMAN: Yes, it could.

MR. ENGLER: If there\'s some sort of pharmaceutical or something that\'s
been produced in the milk that is approved as a drug but then the animal
itself has never been approved and there might be quite a few of them if
there was a very high production possibility.

MS. TUCKER-FOREMAN: But that really requires a safety determination.

MR. ENGLER: Would the milk be considered food? That\'s a pharmaceutical
then. Is that we\'re talking, non-food GM, is that what I heard? But
when do you drink the milk? When is it an adulterant?

MS. DILLEY: Can we only have one conversation because I\'m not hearing
you, Michael.

MR. ENGLER: The question was if there\'s something in the milk that made
it a drug is it a drug or is it food and I don\'t know.

DR. CARDINEAU: But you wouldn\'t go to the grocery store to buy it.

MR. ENGLER: Well, you could. The license is on the milk. Davis just
published a paper on conferred resistance to *E. coli* in baby pigs.

MS. TUCKER-FOREMAN: What is the product that you want to sell, milk?

MR. ENGLER: Milk.

MS. TUCKER-FOREMAN: Okay. And so but it comes from a genetically
engineered animal. It seems to me the animal has to be determined to be
safe.

MR. ENGLER: Just the milk.

MS. TUCKER-FOREMAN: So you\'re just going to keep the animal out of the
food supply.

MR. ENGLER: Possibly. Maybe you can\'t prove the animal is safe but
there\'s really good reason to prove the milk is safe. I don\'t know if
anybody\'s thought about that.

MS. TUCKER-FOREMAN: I haven\'t.

MS. DILLEY: Can we move on to another category? How about animal health
and care? So, I can\'t remember who made the distinction. I thought it
was a good one. Michael. Yeah?

MR. ENGLER: And I\'m not making the distinction specifically but I just
thought animal welfare fit better under ethics.

MS. DILLEY: I think you\'re right.

MR. ENGLER: This has to do with more animal, the health of the animal, I
don\'t know, the health of its cohorts or its herd mates or other
species and also just the animal husbandry of this animal in normal
circumstances, but then there\'s more of an ethical issue of whether or
not you made an animal \-- you might be able to take care of him just
fine. But they\'re not the normal animal that can, you know, live in the
outdoors and maybe that\'s something that has to be considered as far as
the safety to the animal itself. Are they sound or are they fit?

MS. DILLEY: Daryl?

DR. BUSS: Under a heading of safety then I\'m not sure animal husbandry
fits in along there and I guess I don\'t like to see it referred to
under the safety.

MS. DILLEY: Take care out?

MR. ENGLER: How about fitness? How about fitness?

MS. DILLEY: Is there anything in addition to health that you need to
add?

DR. LAYTON: Yes. What happens if this animal jumps up, crosses the
fence, and then crosses with wild. Let\'s say it\'s a silkie. Not if it
creates some kind of problem. I don\'t know. See, I\'m not sure where
environmental impact is here versus \-- you raised this, Mike.

MS. DILLEY: Kind of the larger issue \--

DR. LAYTON: Environment versus animal.

MS. DILLEY: The larger population of livestock or herd. It\'s an
environmental impact piece but it was a different dimension of it. An
individual animal as well as animal population or bigger or whatever you
want to say.

DR. ROBL: That\'s not what I was going to comment on.

MS. DILLEY: Sorry. I was just trying to think of what else is animal
health and on a population level I think that\'s different than the
wild.

DR. ROBL: Since it\'s under the food safety category.

(Discussion off the record)

DR. ROBL: Well, I could talk about food safety from a safety standpoint.
You do want to have healthy animals that goes into the food chain. Now,
that\'s a different \-- probably a different aspect of health than the
animal welfare component of it, but there is that component of it.

From a food safety standpoint and environmental impact, you\'re right,
if the transgene does get into a different population and it\'s ready or
not to be evaluated for food safety impact then that could be an issue.
I\'m not sure that either of those are very good comments on that.

DR. LAYTON: Okay. So, if it\'s going to get out and get into wild,
actually non-GE animals, if there\'s a chance of that you want to put
that under environmental impact?

DR. ROBL: Or, if you have a herd of heifers next

\-- across the fence from a herd with a couple of bulls in there and the
bulls are transgenic and they get across to breed with the heifers and
maybe we don\'t know whether this is the transgenic that has been
assessed for food safety you could say that that\'s an environmental
impact that could have safety issues.

MS. TUCKER-FOREMAN: I think the National Academy of Sciences in their
report described, although this is certainly possible, described the
likelihood of cross breeding among these kinds of food animals as a
fairly unlikely thing. Larisa \-- You can have insects, but \--

DR. RUDENKO: I think there\'s more hair pulling.

MS. TUCKER-FOREMAN: But these animals, livestock, the cattle, I think
there was less concerning the domestic herd.

MS. DILLEY: Alison.

DR. VAN EENENNAAM: Are we talking about livestock now? I thought we
opened this back up to animals.

MS. TUCKER-FOREMAN: Yeah, but \--

MS. DILLEY: We did.

MS. TUCKER-FOREMAN: \-- the specific examples. I think the NAS
categories of those bulls that were most at risk because they not get
out and they cross breed and they came down to the ones that we\'re
talking about as being fairly unlikely to happen.

DR. VAN EENENNAAM: The report based its concerns for fish and insects,
no doubt, but we are talking about animals here so I say it\'s not a big
problem but for this particular \--

MS. TUCKER-FOREMAN: I wasn\'t thinking in terms of fish and I don\'t
think that NAS was talking in terms of fish.

MS. DILLEY: We\'re bouncing around.

DR. LAYTON: So if we want to talk about the environment I\'m okay with
that but I think that with pigs and fish we do have the issue of them
escaping and mixing with wild population. Not that I don\'t want to end
all wild hogs in my State alone, but because I think it\'s based in
exotics, but there is that possibility.

(Discussion off the record)

MS. DILLEY: Steven.

MR. HENSLEY: I don\'t \-- I guess having raised livestock my entire life
I don\'t see how we can seriously think that \-- now I am assuming
something, I am assuming that these animals are eventually going to go
on agricultural farms and I don\'t see how we cannot assume whether,
especially a goat, that\'s what I raised, but goats, heifers, whatever
are not going to escape, either breed into a wild population or breed
into the neighboring food group population, non-GM or GM food,
something\'s going to cross.

And eventually it\'s going to happen. There\'s going to be which in
Rockingham County Virginia, back in the 80\'s there was tremendous flood
and washed through all the chicken coops. The ones it didn\'t kill, it
struck them out into the wild. Whether or not they cross-bred I don\'t
know, but it emptied all the houses, the floods did.

Now, a car going through a fence, a tree across the fence, someone
getting greedy. Somebody taking a non-food GM animal and selling it into
the food market.

I mean, so I\'m just thinking that eventually if we are talking about
this going out into your normal agricultural setting the first day, then
we have to plan on that happening. Now, maybe that\'s not one of our
goals here to do, but I don\'t think we should say it\'s not going to
happen because it\'s non-food. They\'re eventually going to get out.

MS. DILLEY: I think that\'s like plants. You can set up systems and most
of it goes one direction but you can\'t assume that it\'s not. Jim.

DR. ROBL: I guess did we decide then that animal health care and the
environmental be under the safety category?

MS. DILLEY: Yeah, that ended up in safety.

DR. ROBL: Okay. And so we\'re happy with that.

DR. LAYTON: We\'re not unhappy at this point in time.

DR. ROBL: And I guess just to add on to what \-- it may be that there
needs to be provisions for back to and I guess it\'s already up there
but it gets back to this provision for assurance of animals that are not
approved for food. In other words, either doing the research and
development phases where animals are not sent to the food chain. There
needs to be provisions for assurance to keep those out of the food
chain.

Presumably, and I guess the other question to address is if they\'re
approved to go into the food chain and they are out in the domestic
population I agree will have an animal getting out and getting across
the fence. You\'ll have some movement. The question is, is that a
separate issue that needs to be put up there?

MS. DILLEY: You mean the research, breaking it out into the different
stages?

DR. ROBL: I think that during the research and development phase when
before the animal might be approved for food safety is one issue and
then after it\'s approved for food safety it becomes a different issue
and, so, do we separate those two and have effectively a separate
discussion on those, particularly the latter, because I think it\'s more
of an issue.

DR. SCHECHTMAN: I think there were maybe two different things that I
heard from Steve. Maybe he can clarify. There\'s the question of animals
that have been approved for food, when they\'re going to be getting out.
I was not sure what you were saying regarding animals that were never
intended to be used as food like the question of whether or not animals
that are producing pharmaceuticals are going to be on regular farms and
that may be part of the question that you could be addressing.

DR. ROBL: That, I think, is easier to address than the provisions for
double fencing and so forth. Double fencing and those kinds of
provisions are much more difficult when it comes to production
agriculture. So, I think that this really is two different situations
and different types of management systems and the one is much better
contained than what the other one is.

DR. SCHECHTMAN: I was just trying to understand where you were going
versus where \--

MR. HENSLEY: Well, my initial question is, are we talking about non-food
GM animals being moved into the agriculture at some point? I mean, in
other words, look, when a company started a pharmaceutical rice, first
time they did this the rice farmers in the middle of rice country
started growing this so eventually it has been moved quite a distance
away but it\'s still being grown by farmers.

So, are we going to have pharmaceutical-producing non-food animals that
are going to be out there being raised on conventional farms and maybe
they\'re double fenced, maybe they\'re not, I\'m sure they\'ll have
extra security precautions, but are they just going to be across the
road from a normal farm or are we talking about these animals solely
staying in research facilities behind 10 foot tall chain link fence with
security guards, et cetera, et cetera?

DR. ROBL: At the time, those animals that are not intended for food use,
and I think it is under this provision here, do have \-- of course I can
only speak for myself, I don\'t know what the regulations say about
this, but there are provisions from the recombinant DNA point of view of
double fencing of both animals and there are provisions for labeling and
tracking and proper disposal, okay.

So, that part of it I would have very little concern. If the animal is
approved for food use and gets out, then it\'s going to be a different
situation. But I think that the provisions can be put in place or are in
place for those animals that are not approved for food use.

MS. DILLEY: Daryl and then Greg.

DR. BUSS: A couple of things. I was just going to say if it\'s approved,
then it\'s safe, right? So, are you really concerned about those? I\'m
more concerned about the pre-approved and not that they\'re intended to
be approved animals.

MS. DILLEY: Could you speak up? People can\'t hear you.

DR. BUSS: To use the example in the transgenic animal producing
pharmaceuticals is no. They\'re extremely valuable and expensive unlike
a seed, a transgenic seed so while I guess I couldn\'t rule out that
some of these would be modeled for use in the general agriculture I\'m
really struggling to imagine how that would occur, given the value of
the animals. Now, we\'re talking about the animal health and so on.

Just to be clear, we kept using the same terminology so the first header
we had safety in the food supply and then I guess I suggested going down
to the next one and safety for the animal. That\'s the piece we\'re
talking about. And then with that I guess what we\'re \-- it seems to me
it would be pretty glaringly lacking in something simple and under that
is something like morbidity and mortality. Talk about animal fitness,
but what about fitness and death.

MS. DILLEY: Right.

MS. SULTON: Safety to?

DR. BUSS: To. Safety to the animals. And then have the next bullet
underneath that and then scroll down to the where next bullets are right
now.

MS. SULTON: Morbidity?

DR. BUSS: Yes. You can put them together, mortality and morbidity. Then
there were some other bullets underneath that and fitness being one of
them.

MS. DILLEY: Stephanie, Greg, and then Pat.

MS. WHELAN: I was going to say the same thing as Daryl in terms of
legality because I think the same thing in the plants were to produce
the pharmaceuticals as something with much higher value and you can
spend a fortune and I think at the end you\'re going to keep it more
confined and I know that in Hawaii, they\'re doing some pharmaceuticals
that they had armed guards 24 hours around the field so you take a lot
of precautions just because of the value.

Again, the ones that are not \-- as was said is you have the same issues
with the plant is if there is a preference of the consumer to have with
or without genetic engineering then the marketing issue is not standard,
and then jumping the fence is a problem and we really talked about the
same problems that you have with plants.

MS. DILLEY: Greg and then Pat.

MR. JAFFE: I\'m not sure \-- we seem to be jumping between all three
safety things here.

MS. DILLEY: We\'re trying to flush them out.

MR. JAFFE: Okay.

MS. DILLEY: So feel free to jump in.

MR. JAFFE: No, I\'m trying to figure out \-- because we haven\'t talked
about the environmental yet.

MS. DILLEY: Pat?

DR. LAYTON: Yes. I just want to \-- I guess what I was going back to on
the animal health, if it\'s a non-food animal even if it\'s expensive
and I\'ve got lots of ways of protecting it, is there in there anything
about, and maybe this is not the place to do it, how we grow those
animals? Is that animal husbandry there? Does that need to be there?
Does it go somewhere else?

Because, you know, you could literally have a sheep that\'s on one of
our research farms and we could say, okay, we\'re just going to lock it
up and, you know, it\'s 95 or 100 degrees outside in the middle of the
day, do they need to go outside, you know, do you have to have sort of
regulations of how those animals are kept for animal care issues?

MS. DILLEY: That\'s welfare, isn\'t it?

DR. ROBL: From the standpoint of regulations.

DR. LAYTON: AWA doesn\'t control farm animals. Is this producing an
animal for a goat milk or something in it, is that research or is that a
production animal?

MR. JAFFE: Research.

DR. LAYTON: See, I don\'t think that\'s research.

MS. DILLEY: Not once.

DR. LAYTON: Not once you\'ve come up with that.

MS. DILLEY: Didn\'t we sort out animal welfare \--

DR. LAYTON: I just wanted to know where it was. That\'s what I want to
make sure I understand. Then I\'m fine. I just wanted to make sure.

DR. BUSS: I do think you need it somewhere but not from the standpoint
of specific regulations because I don\'t think that makes a lot of
sense.

DR. LAYTON: Okay.

DR. BUSS: Because with transgenic there\'s likely to be, what could well
be specific characteristics on that transgenic that affect how you care
for that animal husbandry that would be unique to that animal. So, I\'d
say it was prescribed by regulation necessarily.

DR. LAYTON: Okay. I just wanted to make sure.

DR. BUSS: I don\'t know if it needs to be captured or not.

DR. LAYTON: Okay. I just wanted to make sure.

MS. DILLEY: Environmental impact. So let\'s get into that one.

DR. LAYTON: We do have escape issues, population, cross-breeding, the
potential for cross-breeding is there but I don\'t think it\'s and/or,
I\'m not sure.

MS. DILLEY: When you talk about environmental impact evaluation part of
it is cross-breeding and that\'s the fish thing and then the other \--
there are other \-- I don\'t know, are there other environmental issues?

DR. BUSS: I guess I don\'t know where you\'d put \-- if we\'re just
talking about specifically the animal.

MS. DILLEY: It covers the safety issue over here. But I don\'t \--

(Discussion off the record)

MR. CORZINE: A question as far as waste products. A way to harvest
tissue disposal may be byproduct and out of that comes a process that
produces a pharmaceutical with milk. Pull the pharmaceutical out and
make sure you have a way to do something with the milk.

MS. SULTON: As a sub-category?

MR. CORZINE: Yeah, I think so. Just in that whole disposal issue.

(Discussion off the record)

MS. DILLEY: Michael?

DR. SCHECHTMAN: Small suggestion about the wording there that you might
want to say waste impacts so it doesn\'t get to what Daryl was talking
about.

MS. TUCKER-FOREMAN: Yeah, waste impacts.

MS. DILLEY: We\'re having all these conversations going on at once so,
okay, Alison.

DR. VAN EENENNAAM: Just we\'ve been going through tentative risks almost
and now in the environmental impact we\'re starting to consider possible
benefits. There are possible benefits all the way through but they
didn\'t get put into the equation so I guess I\'m just confused why you
would allow that coming up in this section if you didn\'t discuss it
earlier.

MS. TUCKER-FOREMAN: What\'s the benefit?

DR. VAN EENENNAAM: There could be potential benefits from the technology
down the road.

MS. DILLEY: I think your question is procedurally why are we talking
about benefits because it just came up.

DR. VAN EENENNAAM: I was kind of thinking about the risk-benefit part of
it was kind of the next one down.

MS. DILLEY: Yeah.

DR. VAN EENENNAAM: But maybe it\'s not. I don\'t know.

MS. DILLEY: We were talking about safety. That\'s the thing. And then we
were talking about environmental impact and risk benefits so we kind of
tied it in. We\'re looking.

MS. TUCKER-FOREMAN: I think we ought to look at this separately.

MS. DILLEY: We talked about that and then we kind of looked in here and
that\'s \--

DR. RUDENKO: Is there a useful word that is neutral that can also
accommodate some of the environmental issues of the first two bullets
and the National Academy of Sciences? Instead of potential for
cross-breeding just say containment.

DR. LAYTON: Do I want to be neutral?

MS. TUCKER-FOREMAN: I\'m not sure of the word by-products is \--

MS. DILLEY: I think the example that Leon gave us to extract what you
want when you\'ve got a byproduct of it and not turning it into American
food or anything else but you\'ve got a byproduct of the process and
then it\'s another term for waste but we\'re kind of \--

MS. TUCKER-FOREMAN: It\'s a waste product in this case. The byproduct
suggests a benefit. Alison obviously if you take byproducts out and you
have containment maybe all that you need there.

DR. LAYTON: I\'m not sure that you don\'t have to have waste management.
I\'m not happy with the byproduct word.

MS. TUCKER-FOREMAN: Take the byproduct word out and say waste product.

DR. LAYTON: Because waste management is an issue and I think
adventitious disposal is an issue.

MS. TUCKER-FOREMAN: Byproduct is something else and it presumes a use
for it.

MR. SLOCUM: No, after they extract the pharmaceutical. It\'s a byproduct
of the process.

MS. DILLEY: Any other environmental impact? I know you\'re starting to
run out of gas but I just want to see if there\'s any other thoughts.

DR. SHURDUT: Competition.

MS. DILLEY: Oh, competition, is that up there.

UNIDENTIFIED FEMALE: Is that environmental?

MS. DILLEY: Yes, because they become more \--

DR. SCHECHTMAN: Competitiveness.

MS. DILLEY: Go ahead.

MR. JAFFE: I was just thinking biodiversity.

DR. LAYTON: And another issue of biodiversity.

MR. JAFFE: Right. Other organisms.

MS. DILLEY: Okay. All right. I know we have ten minutes but I think
it\'s the better part of the hour that causes us to stay and tomorrow
just to look at the agenda we have a presentation in the morning at
nine. We start at 8:30. We\'ll try and capture at least what we have.

And then pick up where we can go through the other categories that we
have in this outline and flesh them out a little bit more, the ethical
one and the marketing piece, and then if we get the general
characteristics we can say something on that and then we need to set up
our work plan between now and the next meeting and what work and how we
want to do it and setting up for the conversation at the next plenary
but also if we\'re going to do any work in between and what that looks
like.

So, we\'ll see you bright and early. Coffee will be here at eight and
we\'ll start at 8:30. Michael, anything else you want to add?

DR. SCHECHTMAN: Yes. Two comments. One on the work. I think just for
folks who have been on the committee for a while, my sense is that in a
way we\'re further along than many of the sessions that we had
previously where we\'re trying to figure out what the proponents of the
paper are because I don\'t think there\'s a lot of intent to go much
more deeply than what\'s in the outline.

So, I think, my hope is that as sometimes has been to write up what
you\'re doing. That remains to be seen but I just wanted to express my
extent of encouragement on that. And I can be proven wrong at any time.

MS. DILLEY: That\'s not the goal.

DR. SCHECHTMAN: That\'s not the goal. My second point will be off the
record before we go to dinner tonight.

DR. LAYTON: Is there anyone leaving early tomorrow that we need to \--
is there anyone who has to leave before 4:00 tomorrow? Steve is not here
tomorrow at all. You have a 4:55 flight. Michael has to leave earlier.
So, if were done by 3:30 it would be better than 4:00. Okay.

DR. SCHECHTMAN: Okay.

(Whereupon, at 4:50 p.m. the meeting was adjourned to reconvene on May
29, 2008 at 8:30 a.m.)